United States Office of Prevention, Pesticides EPA-738-F-93-014
Environmental Protection And Toxic Substances September 1993
Agency (7508W)
R.E.D. FACTS
Butylate
Pesticide AH pesticides sold or used in the United States must be registered by
Registration EpA- based on scientific studies showing that they can be used without posing
unreasonable risks to people or the environment. Because of advances in
scientific knowledge, the law requires that pesticides which were first
registered years ago be reregistered to ensure that they meet today's more
stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human health
and environmental effects of each pesticide. The Agency imposes any
regulatory controls that are needed to effectively manage each pesticide's
risks. EPA then reregisters pesticides that can be used without posing
unreasonable risks to human health or the environment.
When a pesticide is eligible for reregistration, EPA announces this and
explains why in a Reregistration Eligibility Decision (RED) document. This
feet sheet summarizes the information in the RED for butylate.
Use Profile Butylate is a selective herbicide registered solely for use on corn crops
including field com, sweet corn and popcorn, to control grassy and broadleaf
weeds and nutsedge. Formulations include emulsifiable concentrates,
granular and encapsulated forms. Butylate is applied with ground equipment
and is incorporated into the soil immediately after application.
Regulatory Butylate was first registered as a pesticide in the U.S. in 1967. EPA
History issued a Data Call-In (DCI) Notice in 1981, and a Registration Standard in
September 1983 (NTIS PB85-147304), which required additional product
chemistry, toxicology, ecological effects and environmental fete data. The
Agency issued a second DCI in October 1990, requiring submission of
product chemistry, ecotoxicity, toxicology, environmental fete, residue
chemistry and exposure information.
Currently, there are 14 active registered products which contain the
active ingredient butylate. Between 6 and 15 million pounds of butylate are
applied annually, treating 2 to 7% of the field com grown in the U.S.
Butylate is most commonly used in combination with the herbicides atrazine
and/or cyanazine. Butylate/atrazine products are classified as Restricted Use
Pesticides due to ground water concerns.
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Human Health Toxicity
Assessment Based on results of acute toxicity studies, butylate has been placed in
Toxicity Category I for primary eye irritation. (Category I indicates the
greatest and Category IV the lowest degree of acute toxicity.) It has been
placed in Category III for acute oral and dermal toxicity, dermal irritation,
and acute inhalation toxicity. EPA is requiring acute and subchronic
neurotoxicity studies for butylate because it is chemically related to several
pesticides which have shown neurotoxicity in long-term animal studies.
A chronic toxicity study using rats showed decreased body weight gain
and liver effects in high-dose males. A study with Beagle dogs showed de-
creased body weight, increased platelet count, increased thyroid weight and
liver effects at high doses.
Butylate does not appear to be carcinogenic in the mouse. In a study
using rats, a significant increase in benign lesions was found in the livers of
males at the highest dose tested. The Agency has classified butylate as a
"Group E" carcinogen (evidence of non-carcinogenicity for humans).
In developmental toxicity studies, no teratogenicity was found in rats.
Although maternal toxicity was observed at the highest dose level, no
developmental effects were noted at any dose in rabbits. A reproductive
toxicity study using rats showed kidney effects and changes in blood, organ
weights and liver cells at the highest dose level.
Butylate is not mutagenic. Metabolism studies show that it is rapidly
and completely metabolized and excreted, does not bioaccumulate, and does
not produce metabolites of toxicological concern.
Dietary Exposure
People may be exposed to butylate residues when consuming treated
corn. Tolerances or maximum residue limits of 0.1 ppm have been
established for butylate in or on corn grain (including popcorn), fresh corn
(including sweet corn), and corn forage and fodder (please see 40 CFR
180.232). The Agency has reassessed these tolerances and found that no
changes are needed.
Residues of butylate do not concentrate in processed food or feed.
Therefore, no food or feed additive tolerances have been required. Since it
is metabolized rapidly, finite residues of butylate are not expected in meat,
milk, poultry or eggs. There are no residues of concern to be regulated in
rotational crops.
Plant metabolism studies indicate that no residues of intact butylate are
found in corn at harvest. Storage stability studies show that residues of
butylate in corn grain stored frozen remain stable for up to one year, but
decline by about 50% within 2 to 3 years.
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EPA conducted a chronic dietary exposure assessment for butylate using
a Reference Dose (RfD) of 0.05 mg/kg body weight/day, using tolerance-level
residues, and assuming 100% of the crop was treated. A "worst case"
Theoretical Maximum Residue Concentration (TMRC) was estimated for the
overall U.S. population and 22 subgroups. The TMRC for the general
population was found to represent 0.1% of the RfD, and the TMRC for the
most highly exposed subgroups (non-nursing infants and children 1 to 6 years
old) represents 0.3% of the RfD for each subgroup.
Occupational and Residential Exposure
There is potential for dermal and inhalation exposure among workers
involved in mixer/loader/applicator and soil incorporation activities.
However, butylate is of low toxicity so worker exposure studies are not
needed. Further, since butylate is incorporated into soil well before plants are
mature, post-application exposure is unlikely and reentry data are not needed.
Human Risk Assessment
EPA has concluded that the human health risks from current, low-level
exposure to butylate are minimal due to its low acute toxicity and because it
is not believed to cause cancer in humans.
Environmental Environmental Fate
Assessment The available data indicate that butylate is highly volatile and degrades
moderately rapidly under aerobic conditions. Once in the atmosphere,
butylate may be transported in fogs, mists and rainwater. Runoff to surface
water may follow rainfall.
Based on these properties, EPA has additional questions regarding
runoff into surface water (do concentrations of butylate exceed the Levels of
Concern for fish?), persistence (would butylate residues remain at high levels
long enough to present a chronic risk to terrestrial animals ?}, volatility (what
is the amount and nature of residues in air from volatilization of butylate as
a result of normal agricultural use?), and ground water (is degradation
sufficiently rapid to preclude leaching to ground water?). The Agency is
requiring field dissipation studies with volatilization measurements and aged
leaching data to confirm it's assessment of butylate's environmental fate.
Ecological Effects
Technical butylate is practically nontoxic to birds, highly toxic to
freshwater fish, slightly toxic to freshwater invertebrates and relatively
nontoxic to honey bees. Available data indicate a potential for chronic risk
to birds and mammals, but butylate residues are not expected to persist long
enough to allow chronic exposure. Runoff, spray drift and volatility from
sprinkler application can be expected to reach plants in adjacent fields. Thus,
butylate may pose a hazard to endangered or threatened species.
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Ecological Effects Risk Assessment
Based on available use and exposure information, EPA calculated risk
quotients to assess the acute and chronic risks of butylate granular and spray
formulations to small mammals, birds and aquatic organisms. When the risk
quotient is greater than the LOC, the species exposed may be at risk.
Regarding acute exposure, LOC triggers were exceeded for small
mammals and birds. However, based on mitigating factors including
butylate's use patterns, its low acute toxicity to birds, and the feeding habits
and preferences of small mammals, the Agency has concluded that minimal
acute risks actually exist for nonendangered species.
LOC chronic risk triggers also were exceeded for small mammals and
birds, but only immediately after application of butylate granules. The
Agency concludes that actual chronic risks are unlikely based on
environmental fate data and mitigating factors including butylate's volatility,
its use patterns (it is soil incorporated or watered in immediately after
application), and the feeding habits of small mammals and birds, who would
not likely consume enough granules per day required to reach the LEL over
an extended period.
Neither acute nor chronic risks to aquatic organisms appear likely.
Acute risks to nontarget insects also are unlikely. However, since butylate
is a herbicide, risks to nontarget plants are likely.
Endangered Species
Potential acute risks exist for nontarget endangered mammals,
freshwater vertebrates and amphibians. There also is a possibility of chronic
risks to endangered mammals and birds, as well as risks for endangered
plants, which may impact endangered insects. EPA is working with the U.S.
Fish and Wildlife Service to develop a program to avoid jeopardizing the
continued existence of identified species by the use of pesticides. When this
program goes into effect, endangered species labeling will be required.
Additional Data The generic data base for butylate is substantially complete. However,
Required for confirmatory purposes, EPA is requiring additional generic studies
including product chemistry, storage stability, aged leaching, terrestrial field
dissipation with volatilization measurements, seed germination/seedling
emergence, vegetative vigor, aquatic plant growth, droplet size, spray drift
and acute and subchronic neurotoxicity.
EPA also is requiring product-specific data, including product chemistry
and acute toxicity studies, as well as revised Confidential Statements of
Formula and revised labeling for reregistration of pesticide products
containing butylate.
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Product Labeling All end-use butylate products must comply with EPA's current pesticide
Changes Required product labeling requirements. In addition:
• Effluent Discharge Statement
All end-use or manufacturing-use products that may be contained in an
effluent discharged to the waters of the U.S. or municipal sewer systems must
bear the following effluent discharge labeling statement, modified to include
a fish toxicity statement:
This pesticide is toxic to fish. Do not discharge effluent containing this
product into lakes, streams, ponds, estuaries, oceans or other waters
unless in accordance with the requirements of a National Pollution
Discharge Elimination System (NPDES) permit and the permitting
authority has been notified in writing prior to discharge. Do not
discharge effluent containing this product to sewer systems without
previously notifying the local sewage treatment plant authority. For
guidance contact your State Witer Board or Regional Office of EPA.
• Worker Protection Standard (WPS) Requirements
Any product whose labeling permits use in the production of an
agricultural plant on any agricultural establishment (farm, forest, nursery or
greenhouse) must, within the deadlines specified, 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."
Unless specifically directed in the RED document, all statements required by
these two PR Notices must appear on product labeling exactly as instructed
in the PR Notices.
Labels must be revised to comply with the WPS requirements —
• After April 21, 1994, for products distributed or sold by the primary
registrant or any supplementally registered distributors, and
• After October 23, .1995, for products distributed or sold by any
person.
• Restricted Use Pesticides
The 2 registered butylate/atrazine combination products, classified as
Restricted Use Pesticides due to ground water concerns, must retain
current label precautions regarding toxicity and protection of ground and
surface water.
• Personal Protective Equipment (PPE)
The following PPE labeling is required for all end-use products:
Applicators and other handlers must wear;
- Long-sleeved shirt and long pants
- Chemical-resistant or waterproof gloves
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- Shoes plus socks
Registrants must compare these PPE requirements with those on current
labeling (if any), and retain the more protective. For guidance, please
see Supplement Three of PR Notice 93-7.
• Entry Restrictions
A 12-hour restricted entry interval (REI) is required for all uses on all
butylate end-use product labels. This REI should be inserted into the
standard REI statement required by PR Notice 93-7.
The PPE for early entry should be that required for applicators (see
above), except:
• No apron or respirator (if on the label) is required, and
• "Coveralls" must be specified instead of "long-sleeved shirt and
pants."
This information should be inserted into the standard early entry PPE
statement required by PR Notice 93-7.
o Sole Active Ingredient Products - Registrants must adopt these entry
restrictions, and remove any conflicting entry restrictions from their
labels.
° Multiple Active Ingredient Products - Registrants must compare these
entry restrictions with those on current labeling, and retain the more
protective.
• Protection of Aquatic Organisms
The Environmental Hazard Section of the label must include the
following statements:
o For Granular End-Use Products:
This pesticide is toxic to fish. Do not apply directly to water, or to
areas where surface water is present or to intertidal areas below the
mean high-water mark. Runoff may be hazardous to aquatic organisms
in neighboring areas. Do not contaminate water when disposing of
equipment washwater or rinsate.
o For Non-Granular End-Use Products:
This pesticide is toxic to fish. 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.
Regulatory The use of currently registered pesticide products containing butylate as
Conclusion labeled and specified in the RED document will not pose unreasonable risks
or adverse effects to humans or the environment. Therefore, all uses of these
products are eligible for reregistration.
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Products containing butylate as the sole active ingredient may be
reregistered once the generic and product-specific data, revised Confidential
Statements of Formula and revised labeling are received and accepted by
EPA.
Products also containing other active ingredients may be reregistered
only when the other active ingredients are determined to be eligible for
reregistration.
For More EPA is requesting public comments on the Reregistration Eligibility
Information Decision (RED) document for butylate 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 butylate 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 reregistration program, the
butylate RED, or reregistration of individual products containing butylate,
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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REREGISTRATION ELIGIBILITY DECISION DOCUMENT
BOTYLATE
LIST A
CASE 0071
EmRONMENTAL-PROTECTION-AGENCY
OFFlCE-OF-FESTICIDE'HtOCRAMS
SFEaAL-REVTEW-AND-REREGISTRATION-DIVISION
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TABLE OF CONTENTS
BUTYLATE REREGISTRATION ELIGIBILITY TEAM i
GLOSSARY OF TERMS AND ABBREVIATIONS ii
EXECUTIVE SUMMARY iv
I. INTRODUCTION 1
n. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Estimated Usage of Pesticide 3
D. Data Requirements 4
E. Regulatory History 4
m. SCIENCE ASSESSMENT 5
A. Physical Chemistry Assessment 5
B. Human Health Assessment 6
1. Toxicology Assessment 6
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 11
2. Exposure Assessment 11
a. Dietary 11
b. Occupational and Residential 14
3. Human Risk Assessment 14
a. Dietary 14
b. Occupational and Residential 15
C. Environmental Assessment 15
1. Environmental Fate 15
a. Environmental Chemistry, Fate and Transport 15
b. Environmental Fate Assessment 18
2. Ecological Effects 21
a. Ecological Effects Data 22
(1) Terrestrial Data 22
(2) Aquatic Organism Data 23
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Appendix G - Product Specific Data Call-in
Attachment A - Chemical Status Sheet
Attachment B - Product Specific DCI Response Forms (Form A) plus
Instructions
Attachment C - Requirements Status and Registrants' Response Forms
(Form B) plus Instructions
Attachment D - EPA Grouping of End Use Products for meeting Acute
Toxicology Data Requirements.
Attachment E - EPA Acceptance Criteria
Attachment F - List of all Registrant(s) sent this DCI
Attachment G - Cost Share/Data Compensation Forms
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BUTYLATE REREGISTRATION ELIGIBILITY TEAM
Office of Pesticide Programs:
Biolo gical • and • Economic-Analysis-Division
Stephen Jarboe
James Saulmon
Arthur Grube
Environmental-Fate-and-Effects-Division
Arnet Jones
Curtis Laird
Bemice Slutsky
Health-EffectS'Division
Jeffrey Evans
Robert Zendzian
Charles Frick
Paula Deschamp
Registration -Division
Karen Hicks
Van Seabaugh
Sami Malak
Special Review and Reregistration Division
Judy Loranger
Carol Stangel
Policy and Special Projects Staff
Biological Analysis Branch
Biological Analysis Branch
Economic Analysis Branch
Environmental Fate and Groundwater Branch
Ecological Effects Branch
Science Analysis and Coordination Staff
Occupational and Residential Exposure Branch
Toxicology Branch I
Chemical Coordination Branch
Reregistration Support Chemistry Branch
Fungicide-Herbicide Branch
Registration Support Branch
Registration Support Branch
Reregistration Branch
Policy Planning and Operations Branch
Jean Frane
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GLOSSARY OF TERMS AND ABBREVIATIONS
a.i. Active Ingredient
CAS Chemical Abstracts Service
CSF Confidential Statement of Formula
EEC Estimated Environmental Concentration. The estimated pesticide concentration
in an environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
GLC Gas liquid chromatography
HOT Highest Dose Tested
K+CWHR Kernel plus cob with husk removed
An experimentally derived estimate of the median lethal concentration. The
median lethal concentration is that concentration of a chemical in the inspired air
which, when respired will kill 50% of the sampled population. It is expressed
as the mass of a substance per unit volume of air.
An experimentally derived estimate of the median lethal dose. The median lethal
dose is that mass of a chemical which, when administered by any route, will kill
50% of the sampled population. It is expressed as mass of a substance per unit
mass of the animal.
Lethal Dose-low. The lowest dose at which lethality has been observed, either
experimentally or following accidental exposure.
LEL Lowest Effect Level
LOC Level of concern
LOEL Lowest Observed Effect Level
LD
'so
11
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GLOSSARY OF TERMS AND ABBREVIATIONS (cont.)
MATC Maximum Allowable Toxic Concentration
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of recording and tracking
studies submitted.
N/A Not Applicable
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
PAM Pesticide Analytical Manual
PPE Personal Protective Equipment
ppm Parts Per Million
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.
TGAI Technical Grade of the Active Ingredient
TMRC Theoretical Maximum Residue Contribution
TEP Typical End-Use Product
111
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EXECUTIVE SUMMARY
This Registration Eligibility Decision document (RED) addresses the registration
eligibility of the pesticide butylate, Eutylate is a soil incorporated herbicide produced by Zeneca
Inc. and is registered for use on field corn, sweet com and popcorn to control grass, broadleaf
weeds and nutsedge. Butylate formulations include emulsifiable concentrates, a granular form,
and a microencapsulated form. Butylate is applied with ground equipment and is incorporated
into the soil immediately after application. In certain geographic areas, butylate is registered for
application into center pivot irrigation systems, injection into the soil before or at planting, fall
application before the ground freezes, or soil application and incorporation between the rows
after corn emergence. Butylate is cleared for use with compatible fluid fertilizers and for
impregnation on certain dry bulk fertilizer formulations.
Butylate was initially registered as a pesticide in 1967 by the Stauffer Chemical
Company. A Registration Standard was issued in September 1983 (NTIS PB85-147304). This
Registration Standard summarized the available data supporting the reregistration of products
containing butylate used for control of grassy and broadleaf weeds and nutsedge prior to
emergence, and with preplant, at-planting, and postplanting applications. The Registration
Standard also required additional product chemistry, toxicology, ecological effects and
environmental fate data. An October 24, 1990 Data Call-In Notice (DCI) required the
submission of product chemistry, ecotoxicity, toxicology, environmental fate, residue chemistry
and exposure information. The Agency has now completed its review of the butylate data base
including the data submitted in response to the 1983 Registration Standard and the 1990 DCI.
The Agency has determined that the uses of butylate as currently registered will not cause
unreasonable risk to humans or the environment and these uses are eligible for reregistration.
However, for confirmatory purposes, the Agency is requiring that additional generic data be
submitted. These data include product chemistry, storage stability for crop field trials, aged
leaching and terrestrial field dissipation studies with volatilization measurements. The Agency
is also requiring that other generic data be submitted. These data, which include acute and
subchronic neurotoxicity, seed germination/seedling emergence, vegetative vigor, aquatic plant
growth and droplet size and spray drift, are not part of the target database for the reregistration
of butylate.
Based on the results of its reregistration review, the EPA has concluded that all registered
uses of butylate are eligible for reregistration. The Agency has classified butylate as a Group
E carcinogen (signifies evidence of non-carcinogenicity in humans). A reference dose of 0.05
mg/kg/day has been established based on a NOEL of 5 mg/kg/day, with an uncertainty factor
of 100, for increased liver weights in male dogs in a long-term feeding study. 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. Even using
these values, dietary exposure is estimated to be minimal. There are tolerances established for
corn grain (including popcorn), fresh corn (including sweet com) and corn forage and fodder
(including sweet com, field corn, and popcorn). A reassessment of tolerances is included in this
iv
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document and there are no changes in the previously established tolerances. The Agency has
concluded that human health risks from exposure to butylate are minimal due to its low acute
toxicity and current classification as non-carcinogenic to humans. Available data indicate that
technical butylate is practically nontoxic to birds, highly toxic to freshwater fish, slightly toxic
to freshwater invertebrates and relatively nontoxic to honey bees.
Before reregistering the products containing butylate, 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, the Agency may reregister a product based on
whether or not it meets the requirements in Section 3(c){5) of FIFRA. Those products which
contain other active ingredients may be eligible for reregistration only when the other active
ingredients are determined to be eligible for reregistration.
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended
to accelerate the registration of products with active ingredients registered prior to November
1, 1984. The amended Act provides a schedule for the reregistration process to be completed
in nine years. There are five phases to the reregistration process. The first four phases of the
process focus on identification of data requirements to support the reregistration of an active
ingredient and the generation and submission of data to fulfill the requirements. The fifth phase
is a review by the U.S. Environmental Protection Agency (referred to as "the Agency") of all
data submitted to support reregistration.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for reregistration" before calling
in data on products and either reregistering products or taking "other appropriate regulatory
action." Thus, reregistration involves a thorough review of the scientific data base underlying
a pesticide's registration. The purpose of the Agency's review is to reassess the potential
hazards arising from the currently registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to determine whether the pesticide meets
the "no unreasonable adverse effects" criterion of FIFRA.
This document presents the Agency's decision regarding the reregistration eligibility of
the registered uses of butylate. The document consists of six sections. Section I is the
introduction. Section II describes butylate, its uses, data requirements and regulatory history.
Section El discusses the human health and environmental assessment based on the data available
to the Agency. Section IV presents the reregistration decision for butylate. Section V discusses
the reregistration requirements for butylate. Finally, Section VI is the Appendices which support
this Reregistration Eligibility Decision. Additional details concerning the Agency's review of
applicable data are available on request.1
EPA's reviews of data on the set of registered uses considered for EPA's analysis may be
obtained from the OFF Public Docket, Field Operations Division {H7506O, Office of Pesticide
Programs, EPA, Washington, DC 20460.
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H. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility
Decision:
• Common Name: butylate
• Chemical Name: S-ethyl diisobutylthiocarbamate
• CAS Registry Number: 2008-41-5
• OFF Chemical Code: 041405
• Empirical Formula: CnH^NOS
• Trade and Other Names: Sutan +, R-1910, Gennate Plus, Sutazine +
• Basic Manufacturer: Zeneca, Inc.
B. Use Profile
The following is information on the current registered uses of butylate with an
overview of use sites and application methods. A detailed table of these uses can be
found in Appendix A.
Type of Pesticide:
A soil-incorporated herbicide
Mechanism of action:
Inhibits growth in the meristematic region of leaves of grass by unknown
mechanism
Use Groups/sites:
Terrestrial food and feed crop: field corn, popcorn, sweet com,
forage/silage
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Target Pests:
Barnyardgrass; crabgrass; giant, green, and yellow foxtail; goosegrass;
seedling johnsongrass; and nutsedge
Formulation Types Registered:
Emulsifiable concentrate (89.6 %, 88.2 %, 85.1 %, 78.0 %,
(77.3%, 74.2% butylate formulations)
Granular (10% butylate formulation)
Microencapsulated (48.2% butylate formulation)
Technical grade (97.0% technical butylate formulation)
Emulsifiable concentrate combination product of butylate and atrazine
(56,8% butylate), atrazine is suspended in a butylate EC
Granular combination product of butylate and atrazine (18% butylate)
Method and Rates of Application:
Type of Application - ground (broadcast or band)
Equipment - boom sprayer, soil injection equipment, center pivot irrigation, and
granule application
Rates - Butylate is applied as a preemergent, preplant, at plant, postplant or fall
application at the following maximum active ingredient rates to corn,
popcorn and sweet corn:
Emulsifiable concentrate- applied at 6.30 Ibs ai/A
Granular- applied at 4.08 Ibs ai/A
Microencapsulated- applied at 5.994 Ibs ai/A
C. Estimated Usage of Pesticide
Between 6 to 15 million pounds of butylate are applied annually, treating 2 to 7%
of the field corn grown in the United States. No more than 200,000 pounds of butylate
is applied to sweet corn. Butylate is applied to less than 13% of sweet com acreage.
Data are unavailable for popcorn. These estimates are derived from a variety of
published and proprietary sources available to the Agency.
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D, Data Requirements
Data requested in the September 1983 Registration Standard for butylate
included studies on product chemistry, toxicology, ecological effects and
environmental fate. These data were required to support the uses listed in the
Registration Standard. The 1990 DCI required the submission of product
chemistry, ecotoxicity, toxicology, environmental fate, residue chemistry, and
exposure data. Appendix B includes all data requirements identified by the
Agency for currently registered uses needed to support reregistration.
E. Regulatory History
Butylate was initially registered by the Stauffer Chemical Company in
1967. Butylate is a selective herbicide registered solely for use on corn (field,
sweet, and popcorn) for control of grassy and broadleaf weeds and nutsedge.
Butylate is most commonly used in combination with atrazine and/or cyanazine.
Butylate formulations include granular forms, emulsifiable concentrates and an
encapsulated form. The wettable powder formulation and one of the two granular
formulations are sold as package mixes with atrazine. Registered products
containing butylate as the sole active ingredient are not classified as restricted use
at this time. The butylate-atrazine products are currently classified as restricted
use due to groundwater concerns.
Butylate is applied with ground equipment and is incorporated into the soil
immediately after application. In certain geographic areas, butylate is registered
for application into center pivot irrigation systems, injection into the soil before
or at planting, fall application before the ground freezes, or soil application and
incorporation between the rows after corn emergence. Butylate is cleared for use
with compatible fluid fertilizers, and for impregnation on certain dry bulk
fertilizer formulations.
Data Call-In (DCI) notices were issued in 1981 for butylate requiring
chronic feeding, oncogenicity, reproduction and teratology studies. A Reg-
istration Standard for butylate was issued on September 30, 1983 (NTIS #PB85-
147304) which evaluated the studies submitted as a result of the 1981 DCIs. This
Reregistration Eligibility Decision reflects a reassessment of all data which were
submitted in response to the Registration Standard and 1990 Data Call-in.
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m. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
Color: Pale yellow
Physical State: Liquid
Odor: Rubbery sweet
Boiling Point: 107-109°C at 5 mm Hg
Density: 0.9397 g/ml at 20° C
Solubility: 4.4 X 10'3 g/ml of water at 20°C; miscible with organic solvents
Vapor Pressure: 12.9 fim Hg at 25°C., 6.8 /*m Hg at 20°C
Octanol/Water 1.4 x 104 at 25 °C
Partition Coefficient
pH: 5.5 at 22°C
Stability: Stable at elevated temperatures (53 *C) for two weeks. Stable to sunlight,
to moisture, metals and metal ions
Oxidizing/reducing Reacted with oxidizing agent but not reducing agent
Action:
Flammability: Did not flash at 106° C
Explodability: Not thermally explodable up to 250SC
Storage Stability: Stable at ambient temperature for 2 years
Viscosity: 4.81 centistokes at 25°C
Corrosion
Characteristics: Noncorrosive to stainless steel, carbon steel, borosilicate glass, soft glass,
and aluminum
-------
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 this preliminary analysis data gap exists, the Agency considers the
requirement of this study as confirmatory and not critical to the reregistration eligibility decision.
The data requirements and the data gaps are given in Appendix B.
B, Human Health Assessment
1. Toxicology Assessment
At the time of the Registration Standard the following studies were required:
Acute inhalation (rat) study
90 day non-rodent feeding study
Chronic non-rodent toxicity study
Rat and mouse oncogenicity studies
Rat and rabbit developmental toxicity studies
2-Generation reproduction study
Gene mutation study
Chromosomal aberration study
Other genotoxic effects study
General metabolism study
A Data Call-in notice dated 10/24/90 required the submission of a dermal
sensitization study, an acute inhalation study and a 90 day mammalian
neurotoxicity study. The Agency has reviewed the registrant's data waiver
request for the 90 day mammalian neurotoxicity study and concludes that this
study and an acute neurotoxicity study are still required. However, these
requirements are not part of the target database for butylate and do not affect the
reregistration eligibility decision. These studies are required to support the
continued registration of butylate products. The data requirements and data gaps
are given in Appendix B. Summaries of available studies are provided below.
-------
a. Acute Toxicity
The table below summarizes the toxicity results and categories for technical
grade butylate.
-' - "• .. . •••• • • •.••••!'.' ""_.•"_''••<
.............. ... .... •rpEST'""''' ;•-;;,;,.:•;;;.;;.;•
Acute Oral LDX (1)
Acute Dermal LD^ (1)
Acute Inhalation LC» (2)
• :•• • •••"' ' •' ••: " ".'••• •• •'• '.•• •'.. •'•:• '' '• '••".'•• "• ~ '••:••• ••'•.' -.
.;.:.-'.:-.:• .:'.":.:••:: :;:", . ::RESULTS :'. ':•-':. ..'"-:'::;"":: •'
Males > 3500 mg/kg
females > 4000 mg/kg
LD,,, > 2000 mg/kg
LC» = 2.85 mg/L
.;:•-.•.:•-:-:• •-:••• :.•.;••- :-•... ::-
'= TOX CATEGORY
in
III
ffl
1. MRIDs 00063486, 00149316
2. MRID 42389401
The following table is derived from manufacturing use product data
considered lexicologically similar to butylate technical and is for informational purposes only.
-' V •;:-•-.: •v:"::TEST: :•'.--":: -'V-v ='
Primary Eye Irritation (1)
Primary Dermal Irritation
(2)
Dermal Sensitization (3)
'- : =: ::" ":-":.'";"•. "dREStiijis".:^ Vi1":! i? •-."•';
Comeal opacity noted after 21 days
erythema and edema after 24 hours, still
present after 72 hours
Skin sensitizer
TOSC;dAtECJORir
I
in
Not applicable
1. MEID 00063487
2. MRIDs 00063487, 00149316
3. MRID 42123903
Acute Neurotoxicity
An Acute Neurotoxicity Special Study (Guideline 81-8) is a new
requirement. This study is needed, because butylate is chemically related to
several thiocarbamate pesticides which have shown neurotoxicity in long-term
repeated dose studies in rats and/or dogs. The lack of evidence of neurotoxicity
in a chronic rat study of butylate at 400 mg/kg/day does not provide sufficient
evidence that butylate may not be neurotoxic. This study is not part of the
butylate target database.
-------
b. Subchronic Toxicity
90 Day Feeding-Rodent
Two rat feedings studies were reviewed and deemed unacceptable.
However, a 2-year rat feeding study described below satisfies this requirement.
90-Day Feeding - Nonrodent
A 13 week dog feeding study was reviewed and found to be unacceptable
because of procedural deficiencies. However, an acceptable 1-year dog study
described below satisfies this requirement.
21-Day Dermal
Technical butylate was applied five days/week to normal and abraded skin
sites of New Zealand white rabbits as a ten percent solution (20 mg/kg ai) and a
20 percent solution (40 mg/kg ai) . Treated areas showed erythema, dryness,
fissuring, and sloughing. Congestion was reported in kidneys and lungs of treated
animals, but no supportive histopathology for these observations was found by
the investigators. (MRID 00026312)
Subchronic Neurotoxicity (Mammalian)
A waiver request for this requirement was denied, because butylate is
chemically related to several thiocarbamate pesticides that have shown
neurotoxicity in long-term repeated dose studies in rats and/or dogs.
c. Chronic toxicity
Chronic Rodent
An acceptable rodent study is available in the rat. Sprague-Dawley rats
ingested butylate technical at levels of 50, 100, 200, or 400 mg/kg/day for 24
months. The systemic no-effect level was determined to be the lowest dose
tested, 50 mg/kg/day, based on decreased body weight gain at the next higher
dose, 100 mg/kg/day, and above. In addition, increased incidence of periportal
hepatocellular hypertrophy was recorded in high-dose (400 mg/kg/day) males.
(MRID 00125678)
-------
Chronic Nonrodent
An acceptable nonrodent study is available in the dog. Beagle dogs were
given gelatin capsules containing 0, 5, 25, or 100 mg/kg butylate daily for 12
months. A systemic no-effect level was determined to be 5 mg/kg/day, based
on increased relative liver weight in males treated at the next higher dose, 25
mg/kg/day. In addition, high-dose (100 mg/kg/day) males and females showed
decreased body weight, increased platelet count, increased alkaline phosphatase
activity, and increased thyroid/parathyroid weight; hepatocellular vacuo-
lization/vesiculation was also recorded in two males at this dose. (MRID
40389101)
d. Carcinogenicity
The carcinogenicity data requirement for studies in two species is satisfied
by adequate studies in the mouse (MRID 00035844) and rat (MRID 00125678).
In the first study, CD-I mice were fed butylate (in corn oil) for 24 months
at levels providing daily intakes of 0, 20, 80, or 320 mg/kg/day. Although dose-
related non-neoplastic changes were found in livers and kidneys at 80 and 320
mg/kg/day, no increase in neoplastic lesions was recorded at any dose in either
sex. Butylate does not appear to be carcinogenic in the mouse. (MRID
00035844)
The second study was a combined chronic toxicity/carcinogenicity study
in Sprague-Dawley CD rats fed butylate at levels up to equivalent intakes of 400
mg/kg/day. In addition to periportal hypertrophy, a significant increase in
neoplastic nodules (benign lesions) was found in the livers of males at the highest
dose tested, 400 mg/kg/day. (MRID 00125678)
The carcinogenicity of butylate was evaluated on 10/15/92 by the OPP
Peer Review Committee which classified butylate as Group E - evidence of
noncarcinogenicity for humans.
e. Developmental Toxicity
Developmental toxicity data requirements, listed as data gaps in the 1983
Registration Standard, have since been satisfied by adequate studies in rats
(MRID 00131032) and rabbits (MRID 40389102).
Butylate technical, administered orally by gavage to Sprague-Dawley (CD)
rats at doses of 0, 40, 400, or 1000 mg/kg/day caused decreased body weight
gain and increased relative liver weight in dams. Decreased fetal body weight
-------
and increased skeletal effects were found at 400 mg/kg/day and above, but
increased resorptions only at the highest dose tested. No teratogenicity was found
at any dose. The maternal and fetotoxic no observed effect level (NOEL) was
determined to be the 40 mg/kg and the embryotoxic NOEL, 400 mg/kg.
In the rabbit study, butylate was administered at oral doses of 0, 10, 100,
or 500 mg/kg/day. Maternal toxicity (decreased body weight gain and increased
ovarian weight) was observed only at the highest dose tested (hence the maternal
NOEL was set at 100 mg/kg), but no developmental effects were noted at any
dose.
f. Reproductive Toxicity
The data requirement for a reproduction study with butylate has been
satisfied with an adequate two-generation study in rats fed butylate technical at
levels of 0, 200, 1000 or 4000 ppm (MRID 00160548).
Decreased food consumption in parental males and decreased body weight
in parental females during gestation and lactation were observed at 1000 ppm (50
mg/kg/day), while decreased body weight in F2a (second generation) pups and
decreased absolute brain weight in Ftb (first generation) male weanlings were
noted at the same level.
Increased incidences of dilated renal pelvis and retinal folds were observed
in the Ftb animals but only at 4000 ppm (200 mg/kg/day). Other treatment
related systemic and reproductive effects were noted at the highest dose tested,
including hematological and organ weight changes, as well as increased
hepatocyte vacuolization. The maternal and developmental NOELs were found
to be 200 ppm and 1000 ppm, respectively,
g. Mutagenicity
Acceptable studies are available which report that technical butylate does
not induce gene mutations in Ames testing in bacteria (MRIDs 00149317 and
00162707) or in mouse lymphoma cell (MRID 00162707), even at doses
producing severe toxicity. The same preparation was also negative for
chromosome damage in mouse lymphoma L5178Y cells (MRID 00162709), as
well as negative for DNA repair in yeast cells (MRID 00149317) and mouse
lymphoma cells (MRID 00162709), and negative for transforming capacity in
BALB/3T3 cells (MRID 00162710).
10
-------
h. Metabolism
A total of five reports on the metabolism of butylate in rats have been
submitted. Together, the reported studies satisfy the metabolism data
requirements for butylate. They indicate that butylate is rapidly and completely
metabolized and excreted. No evidence of bioaccumulation was observed and no
metabolites of toxicological concern were identified. (MRIDs 43680, 43681,
43682, 00250645 and 41037301)
i. Reference Dose
A RfD of 0.05 mg/kg/day has been established for butylate based on a
NOEL of 5 mg/kg/day for increased liver weights observed in males at 25
mg/kg/day in a long-term feeding study in dogs and an uncertainty factor of 100.
An ADI (Acceptable Daily Intake) has not been established by the World Health
Organization.
2. Exposure Assessment
a. Dietary
At the time of the Registration Standard, only field and confined rotational
crop studies were required. The 10/24/90 Data Call-in notice required the
submission of the following studies on com, the only registered crop:
Residue analytical method in plants
Storage stability
Magnitude of the residue in processed foods
Confined rotational crop
The residue chemistry data base for butylate is substantially complete with
the exception of storage stability data that must still be submitted. The storage
stability data are considered confirmatory. The Agency has concluded that this
requirement is not critical to the reregistration eligibility decision. The data
requirements and data gaps are shown in Appendix B. Summaries of available
studies are provided below;
Plant Metabolism
The parent compound butylate is the residue of concern. Studies with
corn seedlings conducted under hydroponic conditions and corn grown under
simulated field conditions indicate that butylate is rapidly absorbed from soil by
the roots, translocated to shoots, and metabolized via oxidation to sulfoxides
followed by transfer of the dialkycarbamoyl moiety to glutathione. Glutathione
11
-------
conjugates are metabolized further to cysteine and 3-thiolactic acid conjugates.
These compounds are then conjugated with malonic acid and glucose. No
residues of intact butylate or of diisobutylamine have been found in corn at
harvest. (MRID s 00020555, 00020558, 00021594, 00021781, 00021822,
00021849, and 00129398)
Animal Metabolism
Greater than 99% of [L4C]butylate administered to laboratory animals
(rodents), is rapidly metabolized to water-soluble compounds which are readily
eliminated by excretion (in urine and feces). Metabolism occurs via
sulfoxidation, hydrolysis, and conjugation (major pathway), and via oxidation and
degradation (minor pathway). No metabolites of lexicological concern were
identified. Data from ruminant and poultry metabolism studies are not required
because of limited potential exposure from residues of butylate on livestock feed
items, and also because of a lack of evidence that residues of butylate exist in
laboratory animals. There is no reasonable expectation of finite residues of
butylate in meat, milk, poultry, and eggs with respect to 40 CFR 180.6 (a)(3) and
no tolerances for animal feed items are required. (MRID 00129397)
Residue Analytical Methods - Plants and Animals
An adequate enforcement method is available for determination of residues
of butylate in or on com grain, forage, and fodder. The enforcement method
(Method A of PAM Vol. II; Sec. 180.232) is a GLC method with
microcoulometric detection and a limit of detection of 0.04 ppm. This
enforcement method has undergone successful Agency method validation on corn
grain. Since no tolerances exist for animal commodities, enforcement methods
for residues of butylate in animal commodities are not required. (MRID
00022848, 00023535, 00024324, 00024776, 00025676, 00063485, 00064183,
00068699, 00074451, 05002372, 05010440, 05013158, 05018944, 42126302)
Storage Stability
The available storage stability data (MRID 41812205) indicate that
residues of butylate are stable in corn grain stored frozen for up to 1 year.
Residues in corn grain stored for 2 and 3 years decline by approximately 50%.
A portion of the samples of corn grain used to provide data supporting the
established tolerances were stored for intervals in excess of 1 year. Reassessment
of the 0.1 ppm tolerance includes the assumption that residues of butylate have
declined 50% during storage. The registrant has been required (DCI dated
10/24/90) to submit the sample storage conditions and intervals for those samples
deemed to be useful for tolerance reassessment. The registrant has submitted
preliminary storage stability data from samples of milled corn grain, where the
12
-------
recovery was 85% of the nominal residue (0-day sample). The adequacy of this
study will be determined when the final report for this study is submitted in
September 1993. The required storage stability data can be considered
confirmatory and does not affect the reregistration eligibility of butylate.
Magnitude of the Residue in Plants
The available residue data from crop field trials provide sufficient
information to reassess the 0.1 ppm tolerances for residues of butylate in/on corn
grain, fresh corn, and corn forage/fodder. This assessment includes the
assumption that residues of butylate may decline up to 50% in samples stored in
excess of 1 year. Residues of butylate in or on about 250 samples of corn grain
or whole ears and about 200 samples of field corn forage and fodder were
nondetectable (< 0.02 to < 0.05 ppm). A portion of these samples was stored for
up to 3 years. Assuming a 50% residue decline in samples of corn grain, forage,
and fodder stored for periods longer than 1 year, residues of butylate are not
expected to exceed the established 0.1 ppm tolerance. (MRID 00020547,
00020548, 00020564, 00021749, 00021751, 00021753, 00021755, 00021759,
00021766, 00021769, 00021783, 00021784, 00021787, 00021794, 00021803,
00021856, 00022846, 00023534, 00023727, 00023816, 00023817, 00023818,
00023819, 00024775, 00026259, 00026260, 00026315, 00026316, 00026974,
00035840, 00037762, 00041699, 00090889, 00093145, 00093221, 00093222,
00098255, 00109470, 00117892, 42406401)
Processed Food/Feed
Corn grain and sweet com cannery waste processing studies indicate that
residues of butylate do not concentrate in processed food/feed items. No
food/feed additive tolerances are required. (MRID 42126301 and 42448701)
Confined Rotational Crops
The confined rotational crop study is adequate to satisfy this guideline
requirement. There are no terminal residues of concern to be regulated in
rotational crops; thus, tolerances on rotational crops need not be established. No
additional residue characterization or field rotational crop studies (GLN 165-2)
are required, and no specific plantback intervals are needed. The parent
compound, butylate, was not identified in any plant tissue extract. Two
metabolites were identified and confirmed in plants from the 30-day rotational
interval. The Agency has concluded that the butylate metabolites, identified in
plants rotated to butylate-treated soil, are not of toxicological concern. Hydrolysis
of the non-extractable fractions yielded residues in hydrolysates and post-
hydrolysis solids predominantly in the 10 ppb range. Residues resulting in
rotational crops do not require regulation. (MRID 42694001)
13
-------
b. Occupational and Residential
At the time of the Registration Standard, no exposure studies were
required. The 10/24/90 Data Call-in notices stated that dermal and exposure
studies were reserved pending the review of required toxicology data.
Although there is a potential for dermal and inhalation exposure for
workers involved with mixer/loader/applicator and soil incorporation activities,
butylate does not meet Agency criteria for additional testing based on available
toxicity studies. In addition, since butylate is soil incorporated well before the
plants are mature, the potential for postapplication exposure during tasks such as
sweet corn harvesting or seed corn detasseling is unlikely. Because butylate does
not meet EPA's exposure or toxicity criteria, postapplication/reentry data are not
required to support the reregistration of this chemical.
3. Human Risk Assessment
a. Dietary
A chronic dietary exposure assessment has been conducted using the
following parameters:
1. Toxicological Endpoint: This assessment used a Reference Dose (RfD) of 0.05
mg/kg body weight/day, based on a No Observed Effect Level (NOEL) of 5.0
mg/kg body weight/day and an uncertainty factor of 100. The NOEL was taken
from a long-term feeding study in dogs which demonstrated increased liver
weights in males at the next dose, 25 mg/kg/day.
2. Residue Information: Food uses in this analysis are the published tolerances on
corn commodities. Published tolerances for this chemical are listed in the
Tolerance Index System (TIS) and 40 CFR §180.232.
This assessment used tolerance level residues and 100 percent crop treated
information to estimate the Theoretical Maximum Residue Contribution (TMRC)
for the overall U.S. population and 22 subgroups. The TMRC represents a worst
case estimate. The TMRC for the general population from all published
tolerances is 5.8 x lO'5 mg/kg body weight/day, representing 0.1% of the RfD.
The most highly exposed subpopulations are non-nursing infants (< 1 year old)
and children (1-6 years old). Assuming tolerance level exposures, the TMRCs
are 1.39 x ItT1 and 1.43 x 10" mg/kg/day, respectively, representing 0.3% of the
RfD for each subgroup. At this time, there are no pending or temporary
tolerances for butylate.
14
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b. Occupational and Residential
The Agency has concluded that human health risks from exposure to
butylate are considered to be minimal due to its low acute toxicity and current
classification as non-carcinogenic to humans. No occupational or residential
exposure data have been required.
C. Environmental Assessment
1. Environmental Fate
a. Environmental Chemistry, Fate and Transport
The Registration Standard required the following environmental
fate studies:
Hydrolysis
Photodegradation in water
Terrestrial field dissipation
Fish accumulation
The 10/24/90 Data CalUn notice required the submission of the
following studies:
Photodegradation in soil
Aerobic soil metabolism
Anaerobic soil metabolism
Leaching/adsorption/desorption
Volatility (Laboratory)
Terrestrial field dissipation
Droplet size spectrum
Drift field evaluation
Two additional field dissipation studies with volatilization measurements,
aged leaching, and spray drift and droplet size data are required to confirm the
reregistration eligibility of butylate. Although data gaps exist, these requirements
are not critical to the reregistration eligibility decision. The data requirements
and data gaps are given in Appendix B. Summaries of available studies are
provided below:
1. Hydrolysis
Butylate did not hydrolyze significantly in pH 5, 7, and 9 sterile
aqueous buffered solutions containing \% acetonitrile incubated in the
dark at ± 25 °C. (MRID 40389111)
15
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2. Photodegradation in water
Butylate does not degrade significantly in sterile aqueous pH 7
buffered solutions while being irradiated continuously for 30 days with a
xenon arc lamp. (MRID 40389111)
3. Photodegradation in air
A photodegradation in air study is not required at this time. If the
volatility measurements required in the field dissipation studies indicate a
concern, the Agency will reconsider the need for this test.
4. Photodegradation on soil
Butylate degraded slowly on loam soil that was irradiated outdoors
in California at approximately 25°C, with an average of 82% of the
butylate remaining undegraded after 30 days of irradiation. No
degradation of butylate occurred in the dark control during the same
period. Two minor degradates, butylate sulfoxide and butylate sulfone,
were identified in the irradiated soil. Because butylate is soil-incorporat-
ed, photodegradation is not likely to be an important route of dissipation
in'the environment. (MRID 42123905)
5. Aerobic soil metabolism
Butylate degraded with a reported half-life of 23.9 days in sandy
loam soil that was incubated for 245 days in darkness at 24°C. The
decline in butylate soil residues was due primarily to volatilization (47%
of the applied radioactivity was present as volatilized parent at day 28)
with aerobic soil metabolism of secondary importance. The nonvolatile
degradates identified were butylate sulfoxide, diisobutylformamide,
oxazolidinone, hydroxyisobutyl butylate, butylate S-acid, butylate N-acid,
and diisobutylamine. At the end of the study, 14CO2 and organic [14C]vol-
atiles (of which >93% were butylate) totaled 21.16 and 57.94% of the
applied, respectively; 14Obound residues comprised 9% of the radioactiv-
ity. (MRID 41812201)
6. Anaerobic soil metabolism
Butylate degraded with a half-life of 63.6 days in anaerobic
(Hooding plus nitrogen atmosphere) sandy loam soil that was incubated in
the dark at 24 °C for up to 60 days following 20 days of aerobic
incubation. The decline in butylate soil residues was due primarily to
16
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volatilization (about 60% of the decline in soil residues during the
anaerobic incubation period was due to volatilization of parent) with
anaerobic soil metabolism of secondary importance. The nonvolatile
degradates identified were butylate sulfoxide, diisobutylformamide,
oxazolidinone, hydroxyisobutyl butylate, butylate S-acid, butylate N-acid,
and diisobutylamine. The predominant volatilized compound was
undegraded butylate. (MRID 41812201)
7. Leaching and adsorption/desorption
Based on batch equilibrium experiments, butylate was determined
to be mobile to moderately mobile in Keeton sandy loam, Columbia
loamy sand, Sorrento loam, and Atterberry silt loam soils. The respective
Freundlich K^ values reported for these soils were 1.48, 4.84? 7.28, and
5.47. These results are for parent butylate only and do not assess the
mobility of degradation products. Aged leaching data are required as
confirmatory data to assess the mobility of butylate degradation products.
(MRID 41812202)
8. Laboratory volatility
Butylate readily volatilized from moist sandy loam soil with 53.1 %
of the applied radioactivity volatilized by 25 hr posttreatment. Butylate
comprised > 95% of the volatilized residues. During the experiment, the
soil was maintained at 25°C and 75% of field moisture capacity, with a
continuous flow of humidified air. (MRID 42123906)
9. Terrestrial field dissipation
In two studies found to be supplemental (MRIDs 41812203 and
41812204), butylate dissipated with half-lives of 12-13 days from the
upper 6-7 inches of sandy loam soil that was treated with a soil-
incorporated application of butylate at 6 Ib a.i./A. Neither butylate nor
monitored degradates were detected deeper than 9 inches.
These studies are considered supplemental for the following
reasons:
(a) Butylate is used exclusively as a corn herbicide, but the studies
were conducted in California which is not a major corn-growing
region. The studies' results, therefore, may not be representative
of butylate's dissipation under typical use conditions.
17
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(b) Adequate freezer storage stability data for degradates were not
presented,
(c) One study (MRID 41812204) was initiated during July when air
and soil temperatures were elevated and therefore the dissipation
reported is probably not representative of the compound's typical
use. Butylate is normally applied during or near corn planting
time (April - May). The other study (MRID 41812203) cannot be
used toward fulfillment of the data requirement because the time
zero soil samples did not confirm the application rate. As
confirmatory data, two field dissipation studies are required.
10. Bioaccumulation in fish
The studies submitted provide supplemental information regarding
the bioaccumulation in fish. These studies are considered supplemental
because degradates were uncharacterized. [14C]Butylate residues
accumulated in bluegill sunfish continuously exposed to [MC]butylate at
0.12-0.16 ppm, with maximum mean bioconcentration factors of 180x for
edible tissues, 630x for nonedible tissues, and 410x for whole fish; by day
14 of the depuration period, 98-99% of [uC]butylate residues were
eliminated from the fish tissues. (MRIDs 40843901 and 40657401).
11. Spray Drift and Droplet Size
Droplet size spectrum (201-1) and spray drift evaluation (202-1)
data are needed to support the cnemigation application method for
butylate. The registrant may elect to satisfy both data requirements
through the Spray Drift Task Force, provided the Agency does not require
these data in advance of the Task Force's final report (currently scheduled
for 1994).
b. Environmental Fate Assessment
A comprehensive environmental fate assessment includes: 1) how
a chemical dissipates; 2) identification of significant environmental
degradation products if degradation occurs during dissipation and 3)
analysis of where the residues are most likely to persist (e.g., in the
atmosphere, ground water, surface water, target plants). The existing data
base for butylate is sufficient to draw preliminary conclusions about us
dissipation in the environment. However, there are uncertainties associated
with these conclusions and therefore additional data are required to
confirm this preliminary assessment.
18
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Laboratory studies demonstrate what specific processes and relative
rates may be involved with the dissipation of the chemical and the major
environmental degradates. Field studies confirm the laboratory studies
and examine how the competing dissipation processes affect the overall
dissipation rate.
A preliminary assessment from acceptable laboratory data is that
volatilization is an important (and perhaps the major) route of butylate
dissipation. Partially satisfactory field dissipation studies provide indirect
evidence that substantial volatilization occurs under actual use conditions.
At present, however, there is no information related to the amount or
nature of residues resulting from volatilization during normal agricultural
use. It is not possible to quantify the extent of volatilization in the absence
of field volatility data. Mineralization to CO2 occurs also, but this
appears to be secondary to volatilization as a dissipation pathway.
Based on the available data, it can be concluded that butylate is
highly volatile and degrades moderately rapidly under aerobic conditions.
Aerobic soil metabolism indicated that much of the applied butylate
volatilized during the course of the study. The remaining butylate
degraded to CO2. The moderate value of the calculated Henry's Constant
{8.26 X 10"6 atm-m3/mol), combined with the compound's volatility,
indicate that once in the atmosphere, butylate may be transported in fogs,
mists, and rainwater. Because butylate is often applied to bare ground as
a preemergence herbicide or shortly after planting, and because it is
mobile to moderately mobile in soil, runoff to surface water may follow
a rainfall event. Eased on these demonstrated properties, there were
several issues that require attention.
The first issue is run-off into surface water. The aquatic Estimated
Environmental Concentration (EEC) was based upon models developed for
two different scenarios. These were used to determine whether the
concentrations of butylate would exceed the Levels of Concern for fish.
Field studies would increase the certainty of the aquatic EEC by verifying
the model.
With regard to the fish accumulation study, the Agency believes
that no more data should be required for this guideline study for the
following reasons:
1. 98-99% of the 14C butylate residues were eliminated from the fish
tissue within 14 days. Therefore, butylate is unlikely to be a major
bioaccumulator.
19
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2. Although there are unidentified residues in fish, this is unlikely to
present a human health problem because:
a. Butylate is classified as a group E carcinogen, meaning that
there is evidence of noncarcinogenicity for humans.
b. The Agency has concluded that at the current tolerance level
exposures, the TMRCs for the most highly exposed
subpopulations, non-nursing infants and children aged 1-6, are
1.39 x 104 and 1.43 x 10^, representing 0.3 % of theRfd. Thus,
there is little concern that residues in fish tissue will pose non-
cancer risk.
The second issue relates to volatility of butylate. As stated above,
butylate may be transported in mists, fogs and rainwater. The volatile
component of the field dissipation study would provide basic information
relating to butylate in air. At present, no field data exist relating the
amount or the nature of residues in air from volatilization of butylate as
a result of normal agricultural use.
The last issue relates to groundwater. As stated above, the data
indicate that the major routes of dissipation are volatilization of butylate
and degradation to C02. Some of the intermediate compounds appear to
be structurally related to compounds that may be mobile. Degradation and
volatility may not be sufficiently rapid to preclude leaching into ground
water: however, these situations will most likely be rare. Dissociation
constants developed for intermediate compounds on soils would help
confirm that little or no leaching of residues will occur.
In summary, preliminary conclusions can be made about the
dissipation of butylate in the environment. However, there are
uncertainties associated with these conclusions. Consequently, the
following data are required to confirm the assessment of the environmental
fate of butylate but are not critical to the reregistration eligibility decision:
1, A minimum of two field dissipation studies are required. These
two studies are to be conducted in major corn-producing regions where
butylate is commonly used and must reflect typical com cultivation
practices. Because it is available in emulsifiable concentrate (EC),
flowable concentrate (PC), granular, and microencapsulated formulation
and because formulation may influence dissipation, the studies need to
address the effect of formulation on the field dissipation of butylate.
Therefore, at least one field dissipation study must be conducted with the
20
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EC or FC and the second study must use either the granular or
microencapsulated formulation. Volatilization measurements {which may
be acceptable to satisfy the requirement for the field volatility study) are
needed in all field dissipation studies because it appears to play a sig-
nificant role in the environmental fate of butylate.
2. Aged leaching data are necessary to assess the mobility of
butylate degradation products. Because of the volatility issue and the
relatively slow formation of degradates under aerobic soil conditions,
batch equilibrium studies using radiolabeled synthesized degradates are
required to assess degradate mobility.
3. Spray drift data are required but may be fulfilled through the
Spray Drift Task Force.
2. Ecological Effects
At the time of the Registration Standard cold and warm water fish
acute LC50 studies were required. (The remaining ecological effects
studies were either acceptable or not required). The 10/24/90 Data Call-in
notice required the submission of the following studies:
Estuarine/marine toxicity - fish
A fish early lifestage study
Seed germination/seedling emergence
Vegetative vigor
Aquatic plant growth
The nontarget plant studies (seed germination, seedling emergence,
vegetative vigor and aquatic plant growth) are not required as part of the
target database for butylate and do not effect the reregistration eligibility
decisions. These plant studies are required to support the continued
registration of butylate products. The data requirements and data gaps are
given in Appendix B. Summaries of available studies are provided below.
21
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a. Ecological Effects Data
(1) Terrestrial Data
A. Effects to Nontarget Birds
(i). Avian Single-Dose Oral LDJO
AVIAN ACUTE ORAL TOXICITY
SPECIES
Mallard Duck
% A.I.
98
LD50
(mg/kg)
>4640
CONCLUSIONS
Practically nontoxic
There is sufficient information from the study cited above to characterize technical
grade butylate as practically nontoxic to birds when exposed orally to a single dose.
(MRID 00025060)
(ii). Avian Dietary
AVIAN SUBACUTE DIETARY TOXICITY
SPECIES
Bobwhite Quail
(1)
Mallard duck
(2)
% A.I.
98.1
Tech
98.1
Tech.
LCSO
(ppm)
>5620
>5620
CONCLUSIONS
Practically nontoxic
1. MRID 00131300
2. MRID 00131299
The studies listed above are sufficient to characterize technical butylate as
practically nontoxic when exposure is through the diet to upland game birds (bobwhite
quail) and waterfowl (mallard duck).
22
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(iii). Avian Reproduction
Based upon the available mammalian reproduction data, the use pattern (typical
application, preplant with incorporation into bare soil), and the available environmental
fate data, avion reproduction tests are not required at this time. If future environmental
fate data (i.e., for microencapsulated or granular formulations) indicate significant
persistence of butylate, the Agency will reconsider the need for these tests.
(2) Aquatic Organism Data
A. Acute Toxicity to Freshwater Fish
(i). Effects of Technical Butylate to Freshwater Fish
FRESHWATER FISH ACUTE TOXICITY
TECHNICAL BUTYLATE
SPECIES
Bluegill sunfish (1)
Rainbow trout (2)
Bluegill sunfish (3)
Bluegill sunfish
(3)
Rainbow trout
(3)
% A.I.
98.2
98.2
98
98
98
LC50
Cppm)
6.4
7.0
0.21
0.47
2.10
CONCLUSIONS
The LC50 values for freshwater fish
range from 0.21-7.0 ppm. Using the
data from the most sensitive species,
bluegill sunfish, technical butylate is
classified as highly toxic to freshwater
fish.
1. MRID 001493 18
2. 00149319
3. 40098991
Using the data from the most sensitive species, bluegill sunfish, there is sufficient
information to characterize technical butylate as highly toxic to freshwater fish.
23
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(ii). Effects of Butylate Formulations to Freshwater Fish
FRESHWATER FISH ACUTE TOXICITY
BUTYLATE FORMULATIONS
SPECIES
Rainbow trout (1)
Bluegill Sunfish
(1)
Bluegill Sunfish
(2)
Rainbow trout
(2)
% A.I.
79.23 (Sutan 6E)
79.23 (Sutan 6E)
Sutan 4S
Microencap-
silated
Sutan 4S
Microencap-
silated
LCSo
(ppm)
5.2
7.2
>500
>700
CONCLUSIONS
Moderately toxic
Practically nontoxic
1. MRID 00021835
2. MRID 00020532
There is sufficient information to characterize a 79.23 percent emulsifiable
concentrate formulation as moderately toxic to coldwater and warmwater fish. A 48
percent microencapsulated formulated product was found to be practically nontoxic to
fish.
B. Fish Early Life-Stage
A fish early life stage study (MRID 42214302) and an addendum (MRID
42773601) were reviewed and found to be scientifically-sound but do not meet the
guideline requirements for a fish early life-stage test because of study defects. Although
flawed, this study shows that the maximum allowable toxic concentration for technical
butylate was greater than 0.30 ppm and less than 0.51 ppm. The study can be used to
conduct a risk assessment, therefore, the Agency will not require another study to
support the presently registered corn use.
24
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C. Acute Toxicity to Freshwater Invertebrates
FRESHWATER INVERTEBRATE ACUTE TOXICITY
SPECIES
Daphnia magna
% A.I.
98
LC5o
(ppm)
11.9
CONCLUSIONS
Slightly toxic
There is sufficient information to characterize technical butylate as slightly toxic to
freshwater aquatic invertebrates.
(MRID 00021841)
D. Acute Toxicity to Estuarine/Marine Organisms
ACUTE TOXICITY ESTUARINE ORGANISMS
SPECIES
Sheepshead Minnow
% A.I.
98.4
LC50
ppm
2.6
CONCLUSION
S
Moderately
Toxic
A 96-hour LCSO study was conducted to determine the acute toxicity of butylate to
estuarine and marine fish. The guideline requirement for technical grade acute testing using an
estuarine/marine fish has been satisfied. (MRID 42214301) Technical butylate was found to be
moderately toxic to sheepshead minnow.
25
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(3) Non-Target Insects Data
ACUTE TOXICITY NONTARGET INSECTS
SPECIES
Honeybee
%
A.I.
TGAI
LD50
^g/bee
>29
CONCLUSIONS
Relatively nontoxic
There are sufficient data to characterize butylate as relatively nontoxic to honey bees.
(MRID 00036935) Therefore, the guideline requirement for the honey bee acute contact LDSO
study has been fulfilled.
(4) Non-Target Plants Data
Seven studies were evaluated under this topic and were found to be unacceptable due to
either solubility problems or reporting deficiencies. Phytotoxicity testing is required because the
pesticide may pose a hazard to endangered or threatened species. Runoff, spray drift and
volatility from center pivot sprinkler application can be expected to reach plants in adjacent
fields. Seed germination, seedling emergence, vegetative vigor, and aquatic plant growth studies
are required. These studies are not required as part of the target database for butylate and do not
affect the reregistration eligibility decision. These studies are required to support the continued
registration of butylate products.
b. Ecological Effects Risk Assessment
This section consists of numerous risk assessments each covering a different combination
of endpoint and exposure scenario. Each risk assessment includes a risk quotient which
combines the toxicity and exposure information. For each quotient there is an established value
above which the risk is considered to be at a high level of concern (LOC). 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 LOC is lower for endangered species.
26
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Endpoint/Scenario
Mammalian acute
(granular)
Mammalian acute
(spray)
Mammalian chronic
(granular)
Mammalian chronic
(spray)
Avian acute (granular)
Avian acute (spray)
Avian chronic (granular)
Avian chronic (spray)
Aquatic acute
Aquatic chronic
Non-target insects &
plants
Risk Quotient
UVft2
EEC/LC50
EEC/LEL
EEC/LEL
LDso/ft2
EEC/LC5o
EEC/LEL
EEC/LEL
EEC/LC50
EEC/LEL
NOT QUANTIFIED
Nonendangered LOC
0.5
0.5
1.0
1.0
0.5
0.5
1.0
1.0
0.5
1.0
N/A
Endangered
LOC
0.1
0.1
1.0
1.0
0.1
0.1
1.0
1.0
0.05
1.0
N/A
The narrative sections below provide the derivation and value of the appropriate risk
quotients for butylate and an interpretation of its significance.
1. Mammalian Acute Risk Characterization
A. Granular Formulation Exposure
Because data are unavailable for determining the acute toxicity of
butylate to nontarget mammals, the Agency is using data from acute oral
toxicity studies in rats as surrogate data to calculate and define acute
mammalian risks. The Agency is assuming that deer mice, a represen-
tative small mammal, has similar sensitivity as rats to butylate through
acute oral exposure . LD50 values of 3500 mg/kg and 5431 mg/kg, for
male and female rats, respectively, were used.
27
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Based on available use and exposure information, the Agency has
calculated that a maximum estimated environmental concentration (EEC)
of 66 mg ai/ft2 is possible through use of granular butylate at 6.3 Ib ai/A,
the maximum allowable label rate.
For a deer mouse weighing 0.0184 kg this is equivalent to 3587 mg
ai/ft2/kg.
This results in a risk quotient of:
3587/3500 =1.0 LD50's/ft2 for male deer mice
and
3587/5431 = 0.7 LD50's/ft2 for female deer mice
These are both greater than the established level of concern (LOG)
for granular formulations of 0.5 LD5(/ft2".
Based on these calculations, it appears that small mammals may be
at risk from use of granular butylate. It is important to note, however, that
because of the mitigation factors listed below, it is unlikely that the use
of butylate will pose a hazard to nonendangered small mammals.
(1) Butylate is soil incorporated immediately after application which
should reduce exposure to small mammals except, possibly, at turn
row areas;
(2) Small mammals would be required to consume high numbers of
granules, from approximately 597 to 926 granules, to achieve the
risk quotients of 1.0 and 0.7 LD^'s/ft2.
(3) Small mammals such as deer mice, are not likely to ingest
granules, either selectively or accidently as birds may, unless the
granules were to prove attractive to them.
B. Spray Formulation Exposure
This risk assessment is based upon dietary exposure.
Preliminary EEC's from generic residue data indicate that an
application rate of 6.3 Ib ai/A would result in residues of 788 ppm
(typical) up to 1512 ppm (maximum) on short grasses. A deer mouse
consuming 0.0036 kg food/day would receive 2.8 to 5,4 mg butylate/day
at these concentration levels.
28
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This is equivalent to 154 to 293 mg/kg of butylate/day for a .0184
kg deer mouse.
The level of concern for dietary exposure is exceeded when the
expected dietary intake exceeds 1/2 the LD50. In this case, the dietary
exposure is well below 1/2 the LD50 for both males and females (given in
Section A above). This indicates that acute risks to mammals from
dietary exposure following the use of butylate spray formula are unlikely.
2. Mammalian Chronic Risk Characterization
A. Granular Formulation Exposure
The Agency has assumed that the deer mouse and rat have similar
sensitivities to chronic oral butylate exposures. A 2-generation rat
reproduction study resulted in a lowest effect level (LEL) of 50 mg/kg/day
(described in Section HI Elf).
As described in the section on acute mammalian risk for granular
formulations, the maximum EEC from use of granular butylate is 664 mg
ai/ft2, which is equivalent to 3587 mg/kg/ft2 for an animal with the weight
of a deer mouse.
This results in a risk quotient of
3587/50 = 72
This is much greater than the established LOG of 1.0. However,
the Agency concludes that chronic risks to mammals are unlikely to be
great based upon the mitigating factors discussed in the paragraph above
under mammalian acute risk characterization. Further, the available
environmental fate data indicate butylate is highly volatile and likely to
volatilize substantially under actual use conditions thereby mitigating
chronic risks. However, if future environmental fate data indicate
significant persistence of butylate, the Agency will reexamine the chronic
mammalian risks at that time.
B. Spray Formulation Exposure
The LEL of 50 mg/kg cited in the above section on granular
formulation exposure is equivalent to 256 ppm for an animal with the
weight and food consumption of a deer mouse (provided in the section on
acute mammalian risk).
29
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As stated in the section on acute mammalian risk, preliminary
EECs of 788 to 1512 ppm have been calculated for butylate on short
grasses.
This would result in a risk quotient of
788/256 = 3.1
to 1512/256 = 5.9
which exceed the established LOG of 1.0 for chronic risk,
However, residues on short grasses are not particularly appropriate
to the deer mouse diet. More appropriate food items evaluated in the
same generic data base as the short grasses are fruits, forage, and insects.
EECs based on these items are 44-365 maximum and 9-208 typical.
These EECs lead to a range of risk quotients
from 9/256 = 0.04
to 365/256 = 1.4
Although the risk quotients based upon maximum residues
even on these items exceed the LOG, it is questionable whether the
residues would persist at these levels long enough to constitute
chronic exposure. The available fate data indicate that butylate is
highly volatile and likely to volatilize substantially under actual use
conditions. At present, it is unlikely that small mammals exposed
to chronic exposures will be at risk. However, if future
environmental fate data indicate significant persistence of butylate,
the Agency will reexamine the chronic mammalian risks at that
time.
3, Avian Acute Risk Characterization
A. Granular Formulation Exposure
As stated in the ecological effects data section, the only
avian oral LD50 available is >4640 mg/kg from a study in the
mallard duck. The value 4640 mg/kg is used to quantitate acute
oral toxicity to all birds.
30
-------
The EEC for granular formulation is 66 mg ai/ft2, as
already stated for mammalian risk.
For a small bird such as a field sparrow (weighing 0.014
kg) this is equivalent to 4714 mg ai/kg/ft2.
This results in a risk quotient of:
4714/4640 =1.0
which exceeds the LOG of 0.5. The LOG would not be exceeded
for any birds as large as or larger than a robin.
Even though the calculated quotient exceeds the LOG for
small birds, the Agency has concluded that minimal acute risks
exist for nonendangered avian species exposed to granular butylate
because: (I), all LD50 values are "greater than" values and it is
not known what the LD
-------
This would result in a risk quotient of
365/1501 = 0.24
which is below the LOG for acute risk.
The risk quotient for a mallard, which is more likely to consume
grasses is based upon a higher LC50.
i.e. 1512 = 0.27
5620
This also fails to exceed the LOG.
The Agency concludes, therefore, that acute risks to birds from
spray formulations will be minimal.
4. Avian Chronic Risk Characterization
Because no chronic data on birds are available, the Agency has
used the rat reproduction study, already cited in the mammalian chronic
risk section.
The LEL of 50 mg/kg found for rats is assumed for birds.
A. Granular formulation exposure
For granular formulations the EEC of 66 mg ai/ft2 used for the
granular risk assessments set forth in earlier sections applies.
As stated in the avian acute risk section, this is equivalent to 4714
mg ai/kg/ft2 for a small bird such as a field sparrow.
This results in a risk quotient of
4714/50 = 94.3
for small birds.
For a much larger bird such as a mallard (weighing about 1 kg),
the equivalent exposure would be 66 mg ai/kg/ft2 and the corresponding
risk quotient is: 66/50 =1.3
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Both of these exceed the established LOG of 1.0 for chronic risk.
However, since butylate appears highly volatile and is,
furthermore, soil incorporated or watered in immediately following
applications, it is unlikely that birds will consume sufficient number of
granules to achieve LEL daily throughout their reproductive cycle.
Therefore, the Agency concludes that high chronic risk to birds
from granular butylate is unlikely. However, if future environmental fate
data indicate significant persistence of butylate, chronic avian risks will
be reexamined at that time.
B. Spray Formulation Exposure
Again, the LEL of 50 mg/kg from the rat reproduction study is
assumed to apply to birds.
This is equivalent to 149 ppm in the diet for a small bird such as
a field sparrow and to 1,000 ppm for a much larger bird such as a
mallard.
The dietary EECs are described in previous section and range from
9 to 1512 ppm, depending on the food item.
For the high end of this EEC range (1512 ppm) the risk quotients
range from
1512/149 = 10. for a field sparrow
down to 1512/1000 = 1.5 for a mallard.
However, only the mallard is likely to eat the grasses to which this
EEC applies.
As explained in the section on acute risks, the EECs for the foods
likely to be consumed by a field sparrow are 365 ppm or less. This
results in a risk quotient
of 365/149 = 2.4
for the field sparrow.
All of these risk quotients are above the LOG of 1.0 for chronic
risk.
33
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However, given the apparent volatility of butylate, it is unlikely
that birds will consume foods with residues high enough to achieve the
LEL throughout their reproductive cycle.
Therefore the Agency concludes that chronic risk to birds from
butylate spray formulation is unlikely. However, if future environmental
fate data for the microencapsulated or granulated formulations indicate
significant persistence of butylate, the chronic avian risks will be
reexamined at that time.
5. Aquatic Risk Characterization
Acute. Of the aquatic species tested (see the section on aquatic
organism data) the most sensitive species is the bluegill sunfish, with a
lowest LCso of 0.21 ppm or 210 ppb. This LC30 is used for the aquatic
acute risk assessment.
The Estimated Environmental Concentration for butylate in aquatic
environments was derived from models developed for two different
scenarios: 1) corn grown on Loring Silt Loam in Mississippi; and (2) corn
grown on Fatette Silt Loam in Iowa. Using estimates from these two
sites, acute EEC's were calculated to range from 70 to 76 ppb.
This results in a maximum acute risk quotient of
76/210 = 0.4
which is well below the LOG of 0.5 for acute risk to non-endangered
species. It is, therefore, unlikely that acute risks exist for non-endangered
freshwater fish, invertebrates or marine species.
Chronic risks. The MATC of 0.39 ppm (390 ppb) from the
fathead minnow study is used to quantitate chronic aquatic toxicity.
The chronic EECs derived from the model described above range
from 30 to 34 ppb.
This results in a risk quotient of
34/390 = 0.09
This is below the aquatic chronic LOG of 1.0 for non-endangered
species.
34
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The Agency concludes that chronic risks to non-endangered aquatic
species are unlikely. However, as discussed in the environmental fate
section, these EEC calculations are based upon very limited environmental
fate data and will be reconsidered when the confirmatory field dissipation
studies are reviewed.
6. Nontarget Insects Risk Characterization
Based on the available honey bee toxicity data (acute contact LD50
= > 29 ug/bee) and the presently registered use patterns for butylate
(typically: one application preplan! followed by incorporation or watering
in; applications are usually to bare ground; and no applications are made
during crop bloom (tasseling)) the acute risks to nontarget insects are
unlikely.
7. Nontarget Plant Risk Characterization
There is insufficient data to characterize risks to nontarget plants.
The presently available studies lack pertinent data, which need to be
submitted. For other species the studies need to be redone. However,
since butylate is a herbicide, it is assumed that risks to nontarget plants
are likely.
8. Endangered Species Risk Characterization
The risk quotient for endangered species is calculated in the same
way as for non-endangered species. However the LOC is lower for
endangered species acute risk. The table below summarizes the risk
quotients calculated in earlier sections for non-endangered species and
compares them to the corresponding LOCs for endangered species (taken
from the table at the beginning of this section.) Endpoint/scenario
combinations where the risk quotient exceeds the LOC are marked in the
table below with an asterisk.
35
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Endpoint and Scenario
*Mammalian acute
(granular)
Mammalian acute (spray)
*Mammalian chronic
(granular)
^Mammalian chronic
(spray)
* Avian acute (granular)
* Avian chronic (granular)
*Avian chronic (spray)
* Aquatic (fish) acute
Aquatic (fish) chronic
Butylate Risk Quotient
Value
0.7- 1.0
0.03 - 0.08
72
0.04 - 5.9
1.0
1.3 - 94
1.5 - 10
0.4
0.09
LOG for Endangered Species
0.1
0.1
1.0
1.0
0.1
' 1.0
1.0
0.05
1.0
A high level of concern is reached when the risk quotient exceeds the
LOC for endangered aquatic and terrestrial organisms.
Using the above LOCs and considering butylate's presently registered use
patterns, potential acute risks exist for nontarget endangered mammals, birds and
freshwater vertebrates. Although there are mitigating factors, as discussed above
under the acute risk characterization for non-endangered mammals, endangered
mammals may be more sensitive and, therefore, acute risks may exist. Because
of the sensitivity of freshwater vertebrates to butylate, potential risks may exist
for endangered amphibians.
There also may be a possibility of chronic risks to mammals and birds.
Food habits, use patterns, and butylate's volatility are mitigating factors, but the
possibility that endangered mammals and birds are more sensitive to butylate than
non-endangered ones may offset these mitigating factors. In addition, because
butylate is a herbicide, risks are likely for endangered plants and this may impact
endangered insects. EPA is working with the US Fish and Wildlife Service and
other Federal and state agencies to develop a program to avoid jeopardizing the
continued existence of the identified species by the use of pesticides. When the
Endangered Species Protection Program is published in the Federal Register and
36
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subsequent guidance to registrants is given, endangered species labeling
amendments may be required on affected end use products. Labeling statements
for end use products will likely refer users to county specific bulletins specifying
detailed limitations on use to protect endangered species.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission
of relevant data concerning an active ingredient, whether products containing the active
ingredient are eligible for reregistration. The Agency has previously identified and
required the submission of the generic (i.e. active ingredient specific) data required to
support reregistration of products containing butylate 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 butylate. Appendix B
identifies the generic data requirements that the Agency reviewed as part of its
determination of reregistration eligibility of butylate, 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 butylate and to determine that butylate can be used without
resulting in unreasonable adverse effects to human health and the environment. The
Agency therefore finds that all products containing butylate as the sole active ingredient
are eligible for reregistration. However, those products which contain other active
ingredients will be eligible for reregistration only when the other active ingredients have
been determined to be 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 butylate 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 butylate,
if new information comes to the Agency's attention or if the data requirements for
registration (or the guidelines for generating such data) change.
37
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1. Eligibility Decision
Based on the reviews of the generic data for the active ingredient butylate,
the Agency has sufficient information on the health effects of butylate and on its
potential for causing adverse effects in fish and wildlife and the environment.
The Agency concludes that products containing butylate and registered for use on
field corn, sweet corn and popcorn are eligible for ^registration.
The Agency has determined that butylate products, labeled and used as
specified in this Registration Eligibility Document, will not pose unreasonable
risks or adverse effects to humans or the environment.
2. Eligible and Ineligible Uses
The Agency has determined that the uses of butylate on field corn, sweet
com and popcorn are eligible for reregistration. These are the only registered
uses of butylate.
B. Regulatory Position
The following is a summary of the regulatory positions and rationales for butylate.
Where labeling revisions are imposed, specific language is set forth in Section V of this
document.
1. Tolerance Reassessment
Tolerances for residues of S-ethyl diisobutylthiocarbamate in or on food
and feed commodities are currently expressed in terms of parent compound only
(40 CFR 180.232).
Sufficient crop field trial data are available to ascertain the adequacy of
the established tolerances of 0.1 ppm for residues of butylate in or on field corn
grain (including popcorn), sweet corn kernels plus cob with husk removed
(K+CWHR), field com forage and fodder (including popcorn), and sweet corn
forage and fodder. Sufficient data also indicate that residues of butylate do not
38
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concentrate upon processing; therefore, no food/feed additive tolerances are
required. There are no established or proposed Codex maximum residue limits
(MRL) or other international tolerances for residues of butylate.
The Agency is requiring that the entry in 40 CFR 180.232 be amended by
replacing the chemical name "S-ethyl diisobutylthiocarbamate" with the acceptable
common name "butylate." The term negligible residues should be deleted from
the tolerance expression. The tolerances listed in 40 CFR 180.232 should be
modified to reflect current commodity definitions as follows:
Commodity
Corn grain (including
popcorn)
Fresh corn including
sweet corn (kernels
plus cob with husk
removed)
Corn forage and fodder
including sweet corn,
field corn, and popcorn)
Current
Tolerance
(ppm)
0.1
0.1
0.1
Tolerance
Reassessment
(ppm)
0.1
0.1
0.1
Correct Commodity
Definition
Corn, field, grain
Com, pop, grain
Corn, sweet (K 4- CWHR)
Com, field, fodder
Corn, field, forage
Corn, pop, fodder
Corn, pop, forage
Com, sweet, forage
2, Labeling Rationale
The Worker Protection Standard (WPS) for Agricultural Pesticides -40
CFR Parts 156 and 170, established an interim restricted-entry interval of 12
hours for butylate based on the results of acute dermal toxicity, skin irritation and
eye irritation toxicity testing. The Agency considers the 12-hour restricted entry
interval for this chemical a prudent risk-mitigation measure to protect workers.
Therefore, the Agency retains the 12 hour REI and will allow workers to enter
areas treated with butylate during the REI only in the few narrow exceptions
allowed in the WPS.
39
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The Agency considers the use of a long-sleeved shirt, long pants, shoes,
socks, and chemical-resistant gloves a prudent risk-mitigation measure to protect
handlers and early-entry workers from exposure to butylate. Therefore, the
Agency requires that all products that contain butylate bear personal protective
equipment requirements for handlers and early-entry workers that are at least as
protective as these items. If the end-use product labeling already bears personal
protective equipment requirements that are more protective than these items, the
more protective requirements must be retained.
All manufacturing-use or end-use products that may be contained in
effluent discharged to waters of the United States or municipal sewer systems
must bear required labeling.
3. Endangered Species Statement
The Agency does have concerns regarding exposure of endangered animals
and plants to butylate. At the present time, EPA is 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 by the use of
pesticides. When the Endangered Species Protection Program is implemented and
subsequent guidance is given, endangered species labeling amendments may be
required on affected end-use products. Labeling statements for end use products
will likely refer users to county specific bulletins specifying detailed limitations
on use to protect endangered species.
Specific label language is outlined in Section V, Labeling Requirements.
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 butylate for the
above eligible uses has been reviewed and determined to be substantially
complete. However, additional confirmatory information is needed to fulfill data
requirements for the studies listed below.
40
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Product chemistry
Storage stability
Aged leaching
Terrestrial field dissipation with volatilization measurements
Seed germination/seedling emergence
Vegetative vigor
Aquatic plant growth
Droplet size and spray drift
Acute and subchronic neurotoxicity
2. Labeling Requirements for Manufacturing-Use Products
All manufacturing-use products that may be contained in an effluent
discharged to the waters of the United States or municipal sewer systems must
bear the following revised effluent discharge labeling statement in the
"Environmental Hazards" section. Please note that this effluent discharge
statement has been modified to include a required fish toxicity statement.
"This pesticide is toxic to fish. Do not discharge effluent containing this product
into lakes, streams, ponds, estuaries, oceans or other waters unless in accordance
with the requirements of a National Pollution Discharge Elimination System
(NPDES) permit and the permitting authority has been notified in writing prior
to discharge. Do not discharge effluent containing this product to sewer systems
without previously notifying the local sewage treatment plant authority. For
guidance contact your State Water Board or Regional Office of EPA."
AH affected products distributed or sold by registrants and distributors
(supplemental registrants) must bear the above labeling by October 1, 1995. All
products distributed or sold by persons other than registrants or supplemental
registrants after October 1, 1997 must bear the correct labeling. Refer to PR
Notice 93-10 or 40 CFR 152.46(a)(l) for additional information.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide within 8 months 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
41
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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. Please follow the
instructions in the Pesticide Reregistration Handbook with respect to labels and
labeling,
Worker Protection Standard Requirements
Any product whose labeling reasonably permits use in the production of
an agricultural plant on any agricultural establishment (farm, forest, nursery, or
greenhouse) must comply with the labeling requirements of PR Notice 93-7,
"Labeling Revisions Required by the Worker Protection Standard (WPS), and PR
Notice 93-11, "Supplemental Guidance for PR Notice 93-7, which reflect the
requirements of EPA's labeling regulations for worker protection statements (40
CFR part 156, subpart K). These labeling revisions are necessary to implement
the Worker Protection Standard for Agricultural Pesticides (40 CFR part 170) and
must be completed in accordance with, and within the deadlines specified in PR
Notices 93-7 and 93-11. Unless otherwise specifically directed in this RED, all
statements required by PR Notices 93-7 and 93-11 are to be on the product label
exactly as instructed in those notices.
After April 21, 1994, except as otherwise provided in PR Notices 93-7
and 93-11, all products within the scope of those notices must bear WPS PR-
Notice-complying labeling when they are distributed or sold by the primary
registrant or any supplementally registered distributor.
After October 23, 1995, except as otherwise provided in PR Notices 93-7
and 93-11, all products within the scope of those notices must bear WPS PR-
Notice-complying labeling when they are distributed or sold by any person.
Atrazine-Butylate Combination Products
The Agency requires that the two restricted use butylate-atrazine
combination products retain the label precautions that are currently on these
products due to toxicity and ground and surface water concerns for atxazine
compounds.
42
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Personal Protective Equipment, Requirements
The following personal protective equipment (PPE) labeling is required for
all end-use products:
"Applicators and other handlers must wear:
-Long-sleeved shirt and long pants
-Chemical-resistant or waterproof gloves (see instructions below)
-Shoes plus socks"
The glove statement for butylate is the statement established through the
instructions in Supplement Three of PR Notice 93-7.
Registrants of end-use products that contain butylate must compare the
personal protective equipment requirements set forth in this section to the
personal protective equipment requirements, if any, on current labeling and retain
the more protective. For guidance in choosing which requirement is more
protective, see Supplement Three of PR Notice 93-7.
Entry, Restrictions: A 12-hour restricted entry interval (REI) is required for all
uses on all end-use products. All uses are within the scope of the WPS (see PR
Notice 93-7). This REI should be inserted into the standardized REI statement
required by PR Notice 93-7. The personal protective equipment (PPE) for early
entry should be the PPE required for applicators of butylate, except no apron or
respirator (if any is on label) is required and "coveralls" must be specified for
early-entry workers instead of "long-sleeved shirt and long pants." This PPE
should be inserted into the standardized early entry PPE statement required by PR
Notice 93-7.
Sole-active ingredient: End-use products that contain butylate must adopt the entry
restrictions set forth in this section. Any conflicting entry restrictions on current
labeling must be removed.
Multiple-active ingredient: End-use products that contain butylate must compare
the entry restrictions set forth in this section to the entry restrictions on current
labeling and retain the more protective. A specific time-period in hours or days
is considered more protective than "sprays have dried" or "dusts have settled."
The Environmental Hazard Section is to include:
Granular End-Use Products
"This pesticide is toxic to fish. Do not apply directly to water, or to areas where
surface water is present or to intertidal areas below the mean high-water mark.
43
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Runoff may be hazardous to aquatic organisms in neighboring areas. Do not
contaminate water when disposing of equipment washwater or rinsate."
Non-granular EndbUse Products
"This pesticide is toxic to fish. 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.
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
Document (RED), Persons other than the registrant may generally distribute or sell such
products for 50 months from the date of the issuance of this RED. However, existing
stocks time frames will be established on a case-by-case basis, depending on the number
of products involved, the number of label changes, and other factors. Refer to "Existing
Stocks of Pesticide Products"; Federal Register. Volume 56, No. 123,
June 26, 1991.
The Agency has determined that registrants may distribute and sell butylate
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.
44
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APPENDIX A
Table of Use Patterns
Subject to Reregistration
45
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APPENDIX A - Use patterns subject to reregistration for: CASE 0071, BUTYLATE
SITE
Application Type, Application Timing,
Application Equipment
COM: FIELD OR FORAGE/SILAGE OR POP OR SWEET
Soil incorporated treatment. Preplan! (Fall)
or Postplant or Preemergence, Ground
equipment
Soil incorporated treatment, Preplant or
Postplant or Preemergence, Center pivot
irrigation
Soil incorporated treatment, Postplant,
Ground equipment
Soil incorporated treatment, Preplant,
Ground equipment
Maximum
Application
Rate
-------
SITE
Application Type, Application Timing,
Application Equipment
CORN: FIELD OR FORAGE/SILAGE OR POP OR SWEET
Soil injection treatment. At planting or
Preplant, Soil injector equipment
Maximum
Application
Rate
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APPENDIX B
Table of the Generic Data Requirements
and Studies Used to Make the
Reregistration Decision
46
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-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for
the pesticide butylate covered by this Reregistration Eligibility Decision. It contains generic data
requirements that apply to butylate in all products, including data requirements for which a
"typical formulation" is the test substance.
The data table is organized in the following format:
1. Data Requirement (Column 1). The data requirements are listed in the order in
which they appear in 40 CFR, Part 158. The reference numbers accompanying
each test refer to the test protocols set in the Pesticide Assessment Guidelines,
which are available from the National Technical Information Service, 5285 Port
Royal Road, Springfield, VA 22161 (703) 487 - 4650.
2, Use Pattern (Column 2). This column indicates the use patterns for which the
data requirements apply. The following letter designations are used for the given
use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files,
this column lists the identifying number of each study. This normally is the
Master Record Identification (MRID) number, but may be a "GS" number if no
MRID number has been assigned. Refer to the Bibliography appendix for a
complete citation of the study.
47
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APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Butylate
REQUIREMENT
USE PATTERN
CITATION
PRODUCT CHEMISTRY
61-1 Chemical Identity
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-6
63-7
63-8
63-9
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of Limits
Analytical Method
Color
Physical State
Odor
Boiling Point
Density
Solubility
Vapor Pressure
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
00020545, 00026325, 00043679, 00063484,
42123902, 42764702
00063484, 42123901, 42764701
00063484, 42123901, 42764701
00063484, 42123902, 42764702, DATA GAP
00063484, 42123902, 42764702
00023535, 00025676, 00064183, 05018944,
42123902, GS-0071-001, GS-0071-006,
42764702
00026324, 00063484, 42182201
00020535, 00026324, 00063484, 42182201
00063484, 42182201
00063484, 42182201
00021822, 00063484, 42182201
00063484, 42182201
00063484, 42182201
48
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APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Butylate
REQUIREMENT
USE PATTERN
CITATION
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-20
Octanoiy Water Partition
pH
Stability
Oxidizing/Reducing Action
Flammability
Explodability
Storage Stability
Viscosity
Corrosion Characteristics
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
42182201
00026324, 00063484, 42182201
00063484, 42182201
42182201
42182201
42182201
42182201
42182201
42182201
49
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APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Butylate
REQUIREMENT
USE PATTERN
CITATION
ECOLOGICAL EFFECTS
71-1A
71-2A
71-2B
72-1A
72-1B
72-1C
72-1D
72-2A
72-3A
72-4A
123-1A
123-1B
123-2
Acute Avian Oral-Quail/Duck
Avian Dietary (LCSO) - Quail
Avian Dietary (LC^) - Duck
Fish Acute (LCso) - Bluegill
(TGAI)
Fish Acute (LCSO) - Bluegill (TEP)
Fish Acute (LCg,) - Trout (TGAI)
Fish Acute (LCSO) - Trout (TEP)
Aquatic Invertebrate
Estuarine/marine toxicity
fish
Fish Early Lifestage
Seed germination and seedling
emergence
Vegetative Vigor
Aquatic Plant Growth
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
00025060, GS-071-002
00021835, 00131300
00020530, 00131299
00149318, 40098001
00021835, 00020532
00149319, 40098001
00021835, 00020532
00021841, 05001497
42214301
42214302, 42773601
42123909 DATA GAP
42123904 DATA GAP
42123910, 42123911, 42123912, 42123913,
42123914, DATA GAP
50
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APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Butylate
REQUIREMENT USE PATTERN CITATION
141-1 Honey bee acute contact LDS() AB 00036935
51
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APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Butylate
REQUIREMENT
USE PATTERN
CITATION
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
81-8
82-1A
82-1B
82-2
82-5B
83-1A
83-1B
83-2A
Acute Oral Toxicity - Rat
Acute Dermal Toxicity
Acute Inhalation - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation -
Rabbit
Dermal Sensitization
Acute Neurotoxicity
90-Day Feeding - Rodent
90-Day Feeding - Non-rodent
21-Day Derraal-Rabbit/Rat
90-Day Neurotoxicity - Mammal
Chronic Toxicity - Rodent
Chronic Toxicity - Non-rodent
Oncogenicity - Rat
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
00063486, 00149316
00063486, 00149316
00063488, 42389401
00063487
00063487, 00149316
42123903
DATA GAP
Satisfied by 2 year rat study (00125678)
Satisfied by 1 year dog study (40389101)
00026312
WAIVER DENIED, DATA GAP
00035844, 00125678
40389101
00125678
52
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APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Butylate
REQUIREMENT
USE PATTERN
CITATION
83-2B
83-3A
83-3B
83-4
84-2A
84-2B
84-4
85-1
Oncogenicity - Mouse
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
2-Generatiou Reproduction - Rat
Gene Mutation
Structural Chromosomal
Aberration
Other Genotoxic Effects
General Metabolism
AB
AB
AB
AB
AB
AB
AB
AB
00035844
00131032
40389102
00160548
00149317, 00162707
00162709
00162710, 00162708
00043680, 00043681, 00043682, 41197301
129397, 129398
53
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APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Butylate
REQUIREMENT
USE PATTERN
CITATION
ENVIRONMENTAL FATE
161-1 Hydrolysis
161-2 Photodcgradation - Water
161-3 Photodegradation- Soil
162-1 Aerobic Soil Metabolism
162-2 Anaerobic Soil Metabolism
163-1 Leaching/Adsorption/Desorption
163-2
164-1
165-4
Laboratory Volatility
Terrestrial Field Dissipation
Fish Accumulation
AB
AB
AB
AB
AB
AB
AB
AB
AB
40389111
40389111
42123905
00026320, 00043683, 00043684, 41812201
00043684, 41812201
00027139, 00027140, 00043683, 41812202
DATA GAP
00043683, 42123906
00021848, 00023814, 41812203, 41812204
DATA GAP
00020535, 40657401, 40843901
54
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APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Butylate
REQUIREMENT
RESIDUE
165-1
165-2
171-4A
171-4B
171-4
C/D
171-4E
171-4K
CHEMISTRY
Confined Rotational Crop
Field Rotational Crop
Nature of Residue - Plants
Nature of Residue - Animals
Residue Analytical Method
Plant and Animal
Storage Stability
Magnitude of the Residue
-Corn grain (field, pop, and
sweet)
USE PATTERN CITATION
AB 42694001
AB WAIVED
AB 00020555, 00020558, 00021594, 00021781,
00021822, 00021849, 00129398
AB
AB 00022848, 00023535, 00024324, 00024776,
00025676, 00063485, 00064183, 00068699,
00074451, 05002372, 05010440, 05013158,
05018944, 42126302, PP#7F0621
AB 41812205 - DATA GAP
AB 00020547, 00020548, 00020564, 00021749,
00021751, 00021753, 00021755, 00021759,
00021766, 00021769, 00021783, 00021784,
00021787, 00021794, 00021803, 00021856,
00022846, 00023534, 00023727, 00023816,
00023817, 00023818, 00023819, 00024775,
00026259, 00026260, 00026315, 00026316,
00026974, 00035840, 00037762, 00041699,
00090889, 00093145, 00093221, 00093222,
00098255, 00109470, 00117892
55
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APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Butylate
REQUIREMENT
-Corn forage and fodder
171-41
EXPOSURE
201-1
202-1
231
232
Magnitude of the Residue in
processed food/feed
Droplet Size Spectrum
Drift Field Evaluation
Estimation of Dermal Exposure
Estimation of Inhalation Exposure
USE PATTERN CITATION
AB 00020547, 00020564, 00021749, 00021751,
00021753, 00021755, 00021759, 00021766,
00021769, 00021783, 00021784, 00021787,
00021803, 00021856, 00022846, 00023534,
00023727, 00023816, 00023817, 00023818,
00023819, 00024775, 00026259, 00026260,
00026315, 00026316, 00026974, 00035840,
00037762, 00041699, 00090889, 00093145,
00093221, 00093222, 00098255, 00109470,
00117892, 42406401
AB 42126301, 42448701
AB DATA GAP
AB DATA GAP
AB WAIVED
AB WAIVED
56
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APPENDIX C
BIBLIOGRAPHY
Citations Considered to be Part of the Data Base
Supporting Reregistration
57
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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 this Reregistration Eligibility Decision. 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
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 identifying number which 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 a identifiable laboratory or testing facility as the author.
When no author or laboratory could be identified, the Agency has shown the first
submitter as the author.
b. Document Date. The date of the study is taken directly from the document.
When the date is followed by a question mark, the bibliographer has deduced the
date from the evidence contained in the document. When the date appears as
58
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(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 de-
faulted 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.
59
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BIBLIOGRAPHY
GS-0071-001 Food and Drug Administration, Pesticide Analytical Manual (PAM). Vol. II,
Section 180.232.
GS-0071-002 Schafer, E.W. (1972) The Acute Oral Toxicity of 369 Pesticidal, Pharmaceutical,
and Other Chemicals to Wild Birds. Toxicity and Applied Pharmacology, 21:
315-320.
GS-0071-006 Stauffer Chemical Company; Correspondence file for Pesticide Petition
N0.7F0621; DCL:RCB-115142.
00020530 Hall, A.; Henderson, L.; Joiner, R.; et al. (1974) Sutan + 6-E:Safety Evaluation
by a Five-Day Feeding Test in Mallard [sic] Ducks: T-4644. (Unpublished study
received Aug 29, 1974 under 476-2132; submitted by Stauffer Chemical Co.,
Richmond, Calif.; CDL:026623-A)
00020532 Bresolin, P. (1975) Toxicology Laboratory Report-T-5433. (Unpublished study
received Jan 6, 1976 under 476-2180; submitted by Stauffer Chemical Co.,
Richmond, Calif.; CDL:224372-B)
00020535 Stauffer Chemical Company (19??) Chemistry: [Butylate]. (Unpublished study
received Dec 30, 1965 under unknown admin. no.;CDL:123651-A)
00020545 Stauffer Chemical Company (19??) Basic Manufacturing Process of Sutan
Technical. (Unpublished study received Apr 8, 1976 under 476-2180;
CDL:224137-A)
00020547 Sweet, R.; UnicM, R.; Johns, R.D.; et al. (1975) [Summary of Crop Residue
Data for Sutan + 4-S, Sutan + 4-S/Atrazine and Sutan +4-S/Bladex Tank Mixes
on Corn]. (Unpublished study received on unknown date under 5E1587; prepared
in cooperation with Rutgers, the State Univ. of New Jersey, submitted by Stauffer
Chemical Co., Richmond, Calif.; CDL:097088-C)
00020548 Unger, M. (1974) [Residue Data on the Cross-Linked, Polyurea-Type
Encapsulating Polymer]. (Unpublished study received Jan 14,1975 under
5E1587; submitted by Stauffer Chemical Co., Richmond, Calif.; CDL:097088-C
00020555 Fang, S.C, (1969) Thiolcarbamates. Pages 147-164, In Degradation of
Herbicides. By P.C. Kearney and D.D. Kaufman. New York: ? (Also In
unpublished submission received Mar 27, 1972 under unknown admin, no.;
submitted by Stauffer Chemical Co., Richmond, Calif.; CDL:120329-C)
60
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00020558 Gray, R.A.; Tomlinson, G.A, (1967) Metabolism of Radioactive S /z- Ethyl
diisobutylthiocarbamate (Sutan) in Corn and Rats. (Unpublished study received
Mar 27, 1972 under unknown admin, no.; submitted by Stauffer Chemical Co.,
Richmond, Calif.; CDL:120329-Q)
00020564 Stauffer Chemical Company (1975) Crop Residue Report: FSDS No. A- 9644.
(Unpublished study including FSDS nos. A-9594 and A-9644-1; received Jan 6,
1976 under 476-2180; CDL:226295-H)
00021594 Gulf Oil Chemicals Company (1970?) Metabolism of Thiolcarbamates in Plants.
(Unpublished study received Oct 26, 1971 under unknown admin, no.;
CDL:127196-Y)
00021749 Arkebauer, W.G.; Carswell, T.; Morris, W.P.; et al. (1975) Summary of Crop
Residue Data for Sutan on Soybeans. (Unpublished study received May 2, 1975
under 476-2156; submitted by Stauffer Chemical Co., Richmond, Calif.;
CDL:009609-B)
00021751 Nelson, M. (1975) Summary of Crop Residue Data for Sutan + 6.7-E/Bladex
4-WDS Tank Mix on Com. (Unpublished study received May 2, 1975 under
476-2156; prepared in cooperation with Shell Chemical Co., submitted by
Stauffer Chemical Co., Richmond, Calif.; CDL:009609-D)
00021753 Owens, F.; Snell, R.; Stewart, N.; et al. (1975) Summary of Crop Residue Data
for Sutan + 6.7-E Impregnated on Dry Bulk Fertilizers and Applied Pre-plant
Incorporated on Corn. (Unpublished study received May 2, 1975 under
476-2156; submitted by Stauffer Chemical Co., Richmond, Calif.;
CDL:009609-I)
00021755 Burnside, I. (1975) Crop Residue Report: FSDS No. A-S647. (Unpublished study
received May 2, 1975 under 476-2156; prepared by Univ. of Nebraska, submitted
by Stauffer Chemical Co., Richmond, Calif.; CDL:009609-K)
00021759 Lott, C.; Freeman, J.F.; Shriver, J.; et al. (1972) Crop Residue Report: FSDS
No. B-0416. (Unpublished study including FSDS nos. B-0419, B-0321,
B-0320..,, received Jun 2, 1972 under 476-2000; prepared in cooperation with
Reid Brothers and others, submitted by Stauffer Chemical Co., Richmond, Calif;
CDL:003854-B)
00021766 Solether, W.K.; Sweet, R.; Boldt, P.; et al. (1974) Sutan +: Summary of
Residue Trials Employing Broadcast Applications at a Rate of 6 Pounds or Higher
Actual Sutan Per Acre, Pre-plant Incorporated. (Unpublished study received Apr
5, 1974 under 476-2132; prepared in cooperation with Univ. of Illinois and
others, submitted by Stauffer Chemical Co., Richmond, Calif.; CDL:009847-G)
61
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00021781
00021783
00021784
00021769 Freeman, J.F. (1967) Crop Residue Report: FSDS No. 1835. (Unpublished study
including FSDS nos. A 2110, A 2111 and A 2121, received Jul 31, 1969 under
476-2049; prepared in cooperation with Univ. of Kentucky, Experimental Farm,
submitted by Stauffer Chemical Co., Richmond, Calif.; CDL:003883~B)
Stauffer Chemical Company (1974?) Plant Uptake Studies with
[Phenyl-14C]Polyurea Microencapsulated Sutan + ; Project No. 038022.
(Unpublished study received on unknown date under 5E1587; CDL:097088-A)
Thomas, V.M. (1974?) Plant Uptake-Microencapsulated Sutan +: Project No.
038022. (Unpublished study received Jan 14, 1975 under 5E1587; submitted by
Stauffer Chemical Co., Richmond, Calif.; CDL:094353-C)
Staniforth, D.; Heikes, G. (1973) Supportive Residue Data for Bladex(R)
Herbicide Tank Mix Combination with Sutan(R) Herbicide. (Unpublished study
received Jul 11, 1973 under 201-279; prepared in cooperation with Iowa State
Univ. and others, submitted by Shell Chemical Co., Washington, D.C.;
CDL:000984-A)
00021787 Illnicki, R.; Brown, R.W. (1964) Crop Residue Report: FSDS No. 3853.
(Unpublished study including FSDS nos. 3910 and 3946, received Jan 17, 1966
under unknown admin, no., prepared in Cooperation with Pioneer Hi Bred Seed
Co., submitted by Stauffer Chemical Co., Richmond, Calif.; CDL:123637-C)
00021794 Orr, J.P.; Meade, I.; Cole, ?; et al. (1965) Crop Residue Report: FSDS No.
A1758. (Unpublished study including FSDS nos. A 1838, A 1932, A 1934,..,
received Mar 30, 1966 under unknown admin, no., submitted by Stauffer
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00021803 Holsapple, G.; Stagge, K.; Gandrud, D.; et al. (1976) Summary: Sutan + 10-G
Residue Data. (Unpublished study received Jan 29, 1976 under 476-2001;
submitted by Stauffer Chemical Co., Richmond, Calif.; CDL:223351-A)
00021822 Stauffer Chemical Company (19??) Comparative Plant and Animal Metabolism,
and Fish and Wildlife Toxicity Data for Eptam(R), Sutan(R), Tillam(R) and
Vernam(R). (Unpublished study received Mar 27, 1972 under unknown admin.
no.; CDL:120329-A)
00021835 Knott, W.; Beliles, R.P. (1967) R-1910 and R-1910 6-E Safety Evaluation on
Fish and Wildlife (Bobwhite Quail, Rainbow Trout, and Bluegffl Sunfish).
(Unpublished study received Mar 27, 1972 under unknown admin, no.; prepared
by Woodard Research Corp., submitted by Stauffer Chemical Co., Richmond,
Calif.; CDL:120329-T)
62
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00021841 Vilkas, A.G. (1976) Acute Toxicity of Sutan Technical to the Water Flea Daphnia
magna Straus: AES Proj. # 7602-87. (Unpublished study received Apr 25, 1978
under 476-2180; prepared by Union Carbide Corp., submitted by Stauffer
Chemical Co., Richmond, Calif.; CDL:233577-A)
00021848 Stauffer Chemical Company (1975) [Soil Residue Data of Sutan Combinations and
R-25788]: FSDS Nos. A-9229, A-9229-1, A-9229-2, A-10366. (Unpublished
study including FSDS no. A-8034, received Jan 6, 1976 under 476-2180;
CDL:226295-C)
00021849 Bova, D.L.; DeBaun, J.R. (1975?) Estimation of the Amount of Material
Extractable from the Encapsulating Polymer by Water in Commercial
Formulation of Sutan + Encapsulated: Project No. 148233. (Unpublished study
received Jan 6, 1976 under 476-2180; submitted by Stauffer Chemical Co.,
Richmond, Calif.; CDL:226295-E)
00021856 Stauffer Chemical Company (1978) Crop Residue Report: FSDS No. A-11359.
(Unpublished study received Apr 25, 1978 under 476-2180; CDL-.233576-H)
00022846 Kyle, J.; Rister, A.W.; Tiefenthaler, A.; et al. (1978) [Summary of Crop Residue
Data of Sutan and Other Chemicals on Corn]. (Unpublished study received Oct
10, 1978 under 476-2156; prepared in cooperation with Kansas State Univ.,
Experiment Station, submitted by Stauffer Chemical Co., Richmond, Calif.;
CDL:235281-A)
00022848 Patchett, G.G. (1970?) Determination of R-25788 Residues in Corn. Undated
method. (Unpublished study received Oct 10, 1978 under 476-2156; submitted
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00023534 Lake, ?; Shriver, ?; Dyson, ?; et al. (1968) Crop Residue Report: FSDS No.
B-0071. (Unpublished study including FSDS nos. A-2159, B-0032, A-0450...,
received Jul 22, 1968 under 476-2024; prepared in cooperation with Crop
Chemical Testing Service and Univ. of Guelph, submitted by Stauffer Chemical
Co., Richmond, Calif.; CDL;003868-D)
00023535 Patchett, G.G,; Schwab, G.W. (1967) Sutan Residue Method for Corn and Corn
Forage by Gas Chromatography. Undated method RR-67-28. (Unpublished study
received Jul 22, 1968 under 476-2024; submitted by Stauffer Chemical Co.,
Richmond, Calif.; CDL:003868-E)
00023727 Dom, R.W. (1974) [Compatibility of Bladex(R) Herbicide with Commercial
Herbicide and Liquid Fertilizers]. (Unpublished study received Mar 28, 1975
under 201-281; submitted by Shell Chemical Co., Washington, D.C.;
CDL:009627-A)
63
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00023814 Stauffer Chemical Company (1975) [Residues from Sutan on SoiI]:FSDS Nos.
A-9229, A-9229-1, A-9229-2, A-10366. (Unpublished study including FSDS
no.A-8034, received Jan 6, 1976 under 476-2180; CDL:224370-B)
00023816 Stauffer Chemical Company (1975) Crop Residue Report: FSDS No, A-9644.
(Unpublished study received Jan 6, 1976 under 476-2180; CDL:224370-F)
00023817 Stauffer Chemical Company (1975) Crop Residue Report: FSDS No. A-9594.
(Unpublished study received Jan 6, 1976 under 476-2180; CDL:224370-G)
00023818 Stauffer Chemical Company (1975) Crop Residue Report: FSDS No. A-9644-1.
(Unpublished study received Jan 6, 1976 under 476-2180; CDL:224370-H)
00023819 Stauffer Chemical Company (1975) Crop Residue Report: FSDS No. A-9644.
(Unpublished study received Jan 6, 1976 under 476-2180; CDL:224370-I)
00024324 Adelson, B.J.; O'Sullivan, R.P. (1971) Residue Method for Sutan(R), Method
WRC 71-28 dated Apr 1971. (Unpublished study received Jul 7, 1971 under
476-2103; submitted by Stauffer Chemical Co., Richmond, Calif.;
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00024775 Hoffman, L.; Doebler, T.; Parson, W.; et al. (1976) Summary: Sutan+-Atrazine
18-6G: Residue Data. (Unpublished study received Jan 29, 1976 under 476-2103;
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00024776 Adelson, B.J.; O'Sullivan, R.P. (1971) Residue Method for Sutan(R). Method
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476-2103; prepared by Western Research Center, submitted by Stauffer Chemical
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00025060 Fink, R. (1976) Final Report: Acute Oral LD50-Mallard Duck: Project No.
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00025676 Lesh, M.R. (1979) Determination of Residues of R-33865, EPTC, Butylate and
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00026259 Sweet, R.; Ilnicki, R.; Johns, R.D.; et al. (1975) Summary of Crop Residue Data
for Sutan 4-S on Corn. (Unpublished study received Jan 6, 1976 under
476-2180; prepared in cooperation with Rutgers, The State Univ. of New Jersey
and others, submitted by Stauffer Chemical Co., Richmond, Calif.;
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64
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00026260 Dowler, C.; Moyer, R.; Kolwaite, R.; et al. (1975) Summary of Crop Residue
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(Unpublished study received Jan 6, 1976 under 476-2180; prepared in cooperation
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00026307 Horton, RJ. (1966) R-1910, Tech.: Acute Oral LD50-Rats: Technical Report
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00026312 Woodard, M.W.; Woodard, G.; Cornin, M.T.I. (1967) R-1910 6-E Subacute
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00026314 Woodard, M.W.; Woodard, G.; Cronin, M.T.L (1967) R-1910; Safety
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00026315 Stauffer Chemical Company (1967) Summary: [Sutan]. Summary of studies
090S12-M thru 090812-R. (Unpublished study received Aug 17, 1967 under
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00026316 Brown, R.W.; Raleigh, S.M.; Noll, C.J.; et al. (1967) Corn Residue Studies.
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00026320 Gray, R.A.; Weierich, A.J. (1966?) Behavior and Persistence of S Ethyl
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00026324 Stauffer Chemical Company (19??) Sutan(R): Chemical and Physical Properties.
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00026974 Jongeling, C.; Henrickson, A.; Vecker, E.; et al. (1971) Sutan/Atrazine Residue
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cooperation with Gandy Co. and others, submitted by Stauffer Chemical Co.,
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00027139 Weidner, C.W. (1974) Degradation in Groundwater and Mobility of Herbicides.
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00035844 Goldenthal, E.I.; Gunderson, G. (1979) Lifetime Oral Study in Mice: IRDC No.
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00041699 Marxmiller, R.L.; O'SuIlivan, R.; Lesh, M.; et al. (1980) [Residue Study:
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00043680 Thomas, D.B.; Miaullis, J.B.; Vispetto, A.R.; et al. (1979) Metabolism of
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00043681 Bova, D.L.; DeBaun, J.R.; Petersen, J.C.; et al. (1978) Metabolism of
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00090889 Stauffer Chemical Company (1977) [Corn Residues Data: Fonofos].
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68
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T-12999: Final Report. Unpublished study prepared by Stauffer Chemical Co.
187 p.
40389111 Lee, K. (1987) Butylate-Hydrolysis and Aqueous Photolysis Studies: Laboratory
Project ID: RRC 87-101. Unpublished study prepared by Stauffer Chemical Co.,
Richmond Research Center. 72 p.
40657401 Forbis, A. (1987) Uptake, Depuration and Bioconcentration of[Carbon 14]-Sutan
to Bluegill Sunfish (Lepomis macrochirus):Final Report #35817: Project* 140880.
Unpublished study prepared by Analytical Bio-Chemistry Laboratories, Inc. 38
P-
40843901 Halls, T.; Heitkamp, J. (1988) The Metabolism of [Carbon 14]-Butylate in
Bluegill Sunfish (Lepomis macrochirus): Final Report #36391. Unpublished
study prepared by Analytical Bio-Chemistry Laboratories, Inc. 35p.
41197301 Peffer, R.; Campbell, D. (1988) Sutan Metabolism Study in Rats:Final
Report:!-12977. Unpublished study prepared by Environmental Health Center,
Ciba-Geigy. 260 p.
71
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41812201 McBain, B. (19 89) Sutan (Butylate) Aerobic and Anaerobic Soil Metabolism: Lab
Project Number: PMS-298/299: WRC-89-219. Unpublished study prepared by
ICI Americas Inc. 71 p.
41812202 Yeh, S. (1987) Butylate Batch Equilibrium (Adsorption/Desorption) in Four Soils:
Lab Project Number: PMS-274: MRC 87-30. Unpublished study prepared by ICI
Americas Inc. 42 p.
41812203 Wyatt, N.; Higgle, B.; Hoag, R. (1989) Sutan 6. 7-E Field Dissipation Study for
Terrestrial Food Crop Uses Butylate, California 1988: Lab Project Number:
SUTA-88-SD-01: US02-88-103. Unpublished study prepared by ICI Americas
Inc. 180 p.
41812204 McKay, J. (1989) Sutan 6.7-E Field Dissipation Study for Terrestrial Food Crop
Uses Butylate, California 1987-1988: Lab Project Number: RR 89-031B.
Unpublished study prepared by ICI Americas Inc. 196 p.
41812205 Mckay, J. (1989) Butylate-Storage Stability Study: Crops and Soil Storage
Stability Validation for Butylate in Raw Agriculture Commodities and Soil: Lab
Project Number: WRC 89-17. Unpublished by prepared by ICI Americas Inc.
78 p.
42123901 Javdani, K.; Abbay, G. (1991) Description of Beginning Materials and
Manufacturing Process and Discussion of the Formation of Impurities for Sutan:
Lab Project Number: RR 91-087B. Unpublished study prepared by ICI Americas
Inc., Western Research Ctr. 42 p.
42123902 Abbay, G. (1991) Analysis and Certification of Product Ingredients in Sutan
Selective Herbicide: Lab Project Number: APP-0011: RR 91-061B. Unpublished
study prepared by ICI Americas Inc., Western Research Ctr. 117 p.
42123903 Rattray, N.; Leah, A. (1991) Butylate: Skin Sensitization to the Guinea Pig: Lab
Project Number: CTL/P3422: GG 5290, GG 5250. Unpublished study prepared
by ICI (Macclesfield, UK). 24 p,
42123904 Canning, L.; Farmer, D. (1991) Butylate: A Glasshouse Study of Post Emergence
Effects of the Formulation Sutan +6.7 E on Terrestrial Non-Target Plants: Lab
Project Number: 90JH196: RJ0868B. Unpublished study prepared by ICI
Agrochemicals, Jealotts Hill (UK). 58 p.
42123905 Haag, W.; Mill, T. (1988) Photolysis of Butylate on Soil: Lab Project Number:
SRI 5915-1: ICI ENV-008. Unpublished study prepared by Americas, Inc.
34 p.
72
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42123906 McGahen, L. (1991) Volatility of [carbon 14] Butylate Applied to Soil: Lab
Project Number: PMS346: RR-91-009B. Unpublished study prepared by ICI
Americas Inc., Western Research Ctr. (Mtn. View & Richmond). 43 p.
42123909 Farmer, D.; long, L. (1991) Butylate: A Glasshouse Study of Pre Emergence
Effects of an 803 g/litre Emulsifiable Concentrate Formulation on Terrestrial
Non-Target Plants: Lab Project Number RJ1004B: 91JH217. Unpublished study
prepared by ICI Agrochemicals, Jealotts Hill (UK). 36 p.
42123910 Smyth, D.; Tapp, J.; Sankey, S.; et al. (1991) Butylate: Toxicity to the
Blue-green Alga, Anabaena-floss: Lab Project No: T387/H (FT29/91);
BL4175/B. Unpublished study prepared by ICI (Brixham, UK). 25 p.
42123911 Smyth, D.; Tapp, J.; Sankey, S.; et al. (1991) BL4171/B: Butylate: Toxicity to
the Duckweed (Lemna gibba): Lab Project No: BL4171/B : T387/F (FT27/91),
Unpublished study prepared by Imperial Chemical Industries PLC. 25 p.
42123912 Smyth, D.; Tapp, J.; Sankey, S. (1991) BL4152/B: Toxicity to the Marine Alga,
Skeletonema costatum: Lab Project Number: BL4152/BT387/J(FT31/91).
Unpublished study prepared by Imperial Chemical Industries PLC. 22 p.
42123913 Smyth, D.; Tapp, L; Sankey, S.; et al. (1991) BL4148/B: Toxicity to the
Freshwater Diatom Navicula pelliculosa: Lab Proj ect Number T3 87/1 (FT30/91):
BL4148/B. Unpublished study prepared by Imperial Chemical Industries PLC.
22 p.
42123914 Smyth, D.; Tapp, J.; Sankey, S.; et al. (1991) BL4150/B: Butylate:Toxicity to
the Green Alga Selenastrum capricornutum: Lab Project Number: BL4150/B: T38
7/G (FT28/91). Unpublished study prepared by Imperial Chemical Industries
PLC. 22 p.
42126301 Roper, E. (1991) Sutan plus (Butylate)~Magnitude of the Residues of Butylate on
Processed Commodities of Field Corn Grain from Wet and Dry Milling: Lab
Project Number: SUTA-90-PR-01: RR 91059B. Unpublished study prepared by
ICI Americas Inc., Western Research Center. 121 p.
42126302 Dorman, D. (1982) Determination of Butylate Residues in Corn and Soils:
Addendum to Report # RR 91-059B: Lab Project No: 82-53. Unpublished study
prepared by Stauffer Chemical Co., (ICI Americas). 16 p.
42182201 Ericson, J. (1991) Butylate: Physical Properties: Lab Project Number: ENV-031:
RR-90-423B. Unpublished study prepared by ICI Americas, Inc. 57 p.
73
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42214301 Tapp, L; Sankey, S.; Gaunter, L; (1990) Butylate: Determination of Acute
Toxicity to Sheephead minnow (Cyprinodon variegatus): Lab Project Number:
T387/A/FT70/90: BL3923/B. UnpubHshed study prepared by Imperial Chemical
Industries PLC. 19 p.
42214302 Tapp, J.; Maddock.B.; Gaunter, J.; et al. (1990) Butylate:Chronic Toxicity to
Fathead Minnow (Pimepjales promelas) Embryos and Larvae: Lab Project
Number: BL3955/B: FT71/90: T387/B. Unpublished study prepared by Imperial
Chemical Industries PLC. 54 p.
42389401 Rogers, K.; Parr-Dobrzanski, R. (1992) Butylate: 4-Hour Acute Inhalation
Toxicity Study in the Rat: Lab Project Number:CTL/P/3726: HR2116.
Unpublished study prepared by ICI, Alderley Park, UK. 66 p.
42406401 Roper, E. (1992) Sutan+-Magnitude of the Residues of Butylatein Sweet Corn
Kernels and Cannery Waste: Lab Project Number:BUTY-91-PR-01: RR 91-075B,
Unpublished study prepared by ICI Americas, Inc. 69 p.
42448701 Roper, E. (1992) Butylate Corn Grain Processing Study: Addendum #1 [Response
to EPA Review Comments]: Lab Project Number: ER/WRH-82092. Unpublished
study prepared by ICI Americas. 7 p.
42694001 Diaz, D.; Tarr, J. (1993) Uptake and Metabolism of (isobutyl-l-(carbon
14))Butylate Residues from Soil by Confined Rotational Crops: Lab Project
Number: PMS 340: RR 92-102B. Unpublished study prepared by Zeneca Inc.,
Western Research Center. 156 p.
42764701 Jadvani, K. (1993) Description of Beginning Materials and Manufacturing Process
and Discussion of the Formation of Impurities for Sutan: Lab Project Number:
RR 91-087B ADD 1. Unpublished study prepared by Zeneca Ag Products,
Western Research Center. 10 p.
42764702 Farina, L. (1993) Analysis and Certification of Product Ingredients in SUTAN
Selective Herbicide: Lab Project Number: RR 91-061B RES. Unpublished study
prepared by Zeneca Ag Products, Western Research Center. 79 p.
42773601 Sankey, S. (1993) Butylate: Fish Early Life-Stage Toxicity Test Guideline
Reference 72-4A: Addendum # 1 to MRID # 42214302 Response to EPA Review
Comments: Lab Project Number: BRTX-051393: 051393. Unpublished study
prepared by ICI PLC, Brixham Lab. 9 p.
74
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APPENDIX I>
last of Available Related Docnments
75
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APPENDIX D
The following is a list of available documents related to butylate. Its purpose is to provide a
path to more detailed information if it is required. These accompanying documents are part of
the Administrative Record for butylate 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. Butylate RED Fact Sheet (included in this RED)
4. PR Notice 91-2 (Included in this RED) Pertains to the Label Ingredient Statement
Federal publications on butylate are available and may be purchased from the National Technical
Information Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161.
1. Guidance for the Reregistration of Pesticide Products Containing Butylate as the
Active Ingredient (The 1983 Registration Standard): NTIS Stock No. PB85-
147304
2. Pesticide Fact Sheet (No. 6) for butylate: NTIS Stock No. PB87-108940
76
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i UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
VUK*-*
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
PR NOTICE 91-2
NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS,
AND REGISTRANTS OF PESTICIDES
ATTENTION: Persons Responsible for Federal Registration of
Pesticide Products.
SUBJECT: Accuracy of Stated Percentages for Ingredients
Statement
I. PURPOSE:
The purpose of this notice is to clarify the Office of
Pesticide Program's policy with respect to the statement of
percentages in a pesticide's label's ingredient statement.
Specifically, the amount (percent by weight) of ingredient(s)
specified in the ingredient statement on the label must be stated
as the nominal concentration of such ingredient (s) , as that term
is defined in 40 CFR 158.153(i). Accordingly, the Agency has
established the nominal concentration as the only acceptable
label claim for the amount of active ingredient in the product.
II. BACKGROUND
For some time the Agency has accepted two different methods
of identifying on the label what percentage is claimed for the
ingredient(s) contained in a pesticide. Some applicants claimed a
percentage which represented a level between the upper and the
lower certified limits. This was referred to as the nominal
concentration. Other applicants claimed the lower limit as the
percentage of the ingredient (s) that would be expected to be
present in their product at the end of the product's shelf-life.
Unfortunately, this led to a great deal of confusion among the
regulated industry, the regulators, and the consumers as to
exactly how much of a given ingredient was in a given product.
The Agency has established the nominal concentration as the only
acceptable label claim for the amount of active ingredient in the
product.
Current regulations require that the percentage listed in
the active ingredient statement be as precise as possible
reflecting good manufacturing practices 40 CFR 156.lO(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).
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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 l2(a)(l)(C),
while the nominal concentration appearing on the label would be
the routinely achieved concentration used for calculation of
dosages and dilutions.
The nominal concentration would in fact state the greatest
degree of accuracy that is warranted with respect to actual
product composition because the nominal concentration would be
the amount of active ingredient typically found in the product.
It is important for registrants to note that certified
limits for active ingredients are not considered to be trade
secret information under FIFRA section 10(b). In this respect the
certified limits will be routinely provided by EPA to States for
enforcement purposes, since the nominal concentration appearing
on the label may not represent the enforceable composition for
purposes of section l2(a)(l)(C).
III. REQUIREMENTS
As described below under Unit V. " COMPLIANCE SCHEDULE," all
currently registered products as well as all applications for new
registration must comply with this Notice by specifying the
nominal concentration expressed as a percentage by weight as the
label claim in the ingredient(s) statement and equivalence
statements if applicable (e.g., elemental arsenic, metallic zinc,
salt of an acid) . In addition, the requirement for performing
sample analyses of five or more representative samples must be
fulfilled. Copies of the raw analytical data must be submitted
with the nominal ingredient label claim. Further information
about the analysis requirement may be found in the 40 CFR
158.170. All products are required to provide certified limits
for each active, inert ingredient, impurities of toxicological
significance(i.e., upper limit(s) only) and on a case by case
basis as specified by EPA. These limits are to be set based on
representative sampling and chemical analysis(i.e., quality
control) of the product.
The format of the ingredient statement must conform to 4O
CFR 156-Labeling Requirements For Pesticides and Devices.
After July l, 1997, all pesticide ingredient Statements must
be changed to nominal concentration.
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IV. PRODUCTS THAT REQUIRE EFFICACY DATA
All pesticides are required to be efficacious. Therefore,
the certified lower limits may not be lower then the minimum
level to achieve efficacy. This is extremely important for
products which are intended to control pests which threaten the
public health, e.g., certain antimicrobial and rodenticide
products. Refer to 40 CFR 158.640.
In those cases where efficacy limits have been established,
the Agency will not accept certified lower limits which are below
that level for the shelf life of the product.
V. COMPLIANCE SCHEDULE
As described earlier, the purpose of this Notice is to make
the registration process more uniform and more manageable for
both the agency and the regulated community. It is the Agency's
intention to implement the requirements of this notice as
smoothly as possible so as not to disrupt or delay the Agency's
high priority programs, i.e., reregistration, new chemical, or
fast track (FIFRA section 3(c)(3)(B). Therefore,
applicants/registrants are expected to comply with the
requirements of this Notice as follows:
(1) Beginning July 1, 1991, all new product registrations
submitted to the Agency are to comply with the
requirements of this Notice.
(2) Registrants having products subject to reregistration
under FIFRA section 4 (a) are to comply with the
requirements of this Notice when specific products are
called in by the Agency under Phase V of the
Reregistration Program.
(3) All other products/applications that are not subject to
(1) and (2) above will have until July 1, 1997, to
comply with this Notice. Such applications should note
"Conversion to Nominal Concentrations on the
application form. These types of amendments will not be
handled as "Fast Track" applications but will be
handled as routine requests.
VI. FOR FURTHER INFORMATION
Contact Tyrone Aiken for information or questions concerning
this notice on (703) 308-7031.
Ann* E. tindaay,
Registration Diviaion (H-7505
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APPENDIX E
Pesticide Reregistration Handbook
77
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United States Office of October 1991
Environmental Protection Pesticide Programs
Agency
<&EPA Pesticide
Reregistration
Handbook
How to Respond to
the Reregistration
Eligibility Document
(RED)
£.p Printed cr
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PESTICIDE REREGISTRATION HANDBOOK
HOW TO RESPOND TO THE
REREGISTRATION ELIGIBILITY DOCUMENT (RED)
OFFICE OP PESTICIDE PROGRAMS
ENVIRONMENTAL PROTECTION AGENCY
OCTOBER 1991
Printed o* R-• •"'
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PRODUCT REREG1STRATIOH HANDBOOK
TABLE OF CONTENTS
I. Introduction
A. Purpose and Content 1
B. Reregistration Eligibility Document 1
C. Reregistration Process 1
II. Instructions for Responding
A. How and When to Respond 2
B. When No Response Is Needed 5
B. Where to Respond 6
III. Submission of Data and Labels/Labeling
A. Generic Data 6
B. Product Specific Data 7
1. Product Chemistry 7
2. Acute Toxicity 8
3, Product Performance 9
C. Labels/Labeling 10
Appendix
A. Confidential Statement of Formula and Instructions
B, Label Contents
C. Sample Label Formats—General Use & Restricted Use
D. Label Regulations (40 CFR 156.10)
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PESTICIDE REREGISTRATIOS HANDBOOK
I. INTRODUCTION
A. Purpose and Content of this Handboojc
This Handbook provides instructions to registrants on how to
respond to the Reregistration Eligibility Document (hereafter
referred to as the "RED") and how to reregister products.
Section I is this introduction.
Section II contains step-by-step instructions which must be
followed by registrants responding to the RED.
Section III provides additional instructions on the format,
content and other aspects of generic data, product specific data
and labels/labeling which may be required to be submitted.
Detailed instructions are in the Appendix.
B. The Rerecristration Eligibility Document (RED)
Under Section 4 of the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA), as amended in 1988, EPA is required to
reregister pesticides that were first registered before November I,
1984. The RED describes in detail the subject chemical, its uses
and its regulatory history; describes EPA's decision concerning the
eligibility of the uses of the chemical for reregistration; and
explains the scientific and regulatory bases for this decision.
EPA's reviews of the data by scientific discipline are available
upon request. Appendices to the RED contain: (1) a Data Dall-In
Notice which requires submission of generic and product specific
data and which gives directions for responding, (2) a listing of
existing studies that satisfy generic data requirements and (3) a
bibliography of the generic studies EPA has reviewed.
C. The Reregistration Process
Reregistration involves a thorough review of the scientific
data base underlying a pesticide's registration. The purpose of
EPA's review is to reassess the potential hazards arising from the
currently registered uses of the pesticide, to determine whether
the data base is substantially complete or there is need for
additional generic data, and to determine whether the pesticide is
eligible for reregistration. This decision is issued as the RED.
EPA's science reviews and information on the registered
uses considered for EPA's analyses may be obtained from: EPA,
Freedom of Information, 401 M St., S.W., Washington, D.C. 20460.
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If the RED declares that some or all uses of the chemical are
eligible for reregistration, affected registrants roust first
respond within 90 days of receipt to the data call-in portion of
the RED. Within 8 months of receiving the RED, registrants must
submit or cite any data and labels/labeling required for each
product. EPA has until 14 months after the RED is issued (i.e.,
6 months after the registrants' 8 month deadline) to review the
submission for each product and decide whether to reregister it
based on the following criteria:
—whether all of the product specific data and labels/labeling
are acceptable,
—whether all of the uses on the label/labeling are eligible,
—whether all of the active ingredients in the product are
eligible, and
—if no List 1 toxic inert ingredient is contained in the
product (a List 1 inert is permitted only if all data
for it have been submitted and EPA determines
that the inert does not pose any unreasonable adverse
effects in that product).
Products which meet all of these criteria will be
reregistered. Products which do not meet all of these criteria,
but which have acceptable product specific data and labeling, will
be processed as amendments in order to implement label changes
required by the RED..
II. INSTRUCTIONS FOR RESPONDING
A. How and When to Respond
This section provides directions for submitting timely and
adequate responses necessary to reregister products containing the
active ingredient covered by the RED. Registrants must follow
these steps exactly to avoid suspension of their products. All
products containing tne active ingredient in the RED [i.e.,
manufacturing use products, end use products and special local need
{SLN or Section 24c) registrations] are subject to the requirements
of the RED. Figure 1 summarizes how and when to respond to the
RED. A step-by-step explanation follows.
Step 1. Are Expedited Label Changes Reo^jired? In some
instances, EPA may conclude that certain changes to product
labels/labeling must be implemented rapidly. If the RED requires
expedited label/labeling changes, registrants must submit the items
below by the deadline specified in the RED. If expedited label
changes are not required, go to Step 2.
a. Application for Registration (EPA Form 8570-1) . Complete
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and sign the form. In Section II, insert the phrase "Expedited
Amendment in Response to the Reregistration Eligibility Document
for (insert case name for chemical) ." Applications for expedited
label changes will be processed as applications for amended
registration. use only an original application form with a red
identifier number in the upper right-hand corner.
b. Five (5) copies of revised draft label and labeling.
Refer to the RED for label/labeling changes and follow the
instructions in Section III.C. and the Appendix of this Handbook
for revising the label and labeling for each product,
Step 2. Are data required? If the RED requires generic or
product specific data, you must follow the directions in the data
call-in notice in the RED. All registrants must respond for all
products within 90 davs of receipt; products for which an adequate
response is not received on time will be subject to suspension. No
time extensions vill be given for responding within 90
Step 3. Are Uses of a Pesticide Eligible for Rereaistration?
If any uses of the active ingredient(s) covered by the RED are
eligible for reregistration, follow these instructions. If no uses
are eligible, no further response may be needed (see page 5) .
EPA's decision on the eligibility of each of the uses of the
active ingredient (s) is presented in the RED. . If any uses of a
chemical are eligible for reregistration/ registrants for
manufacturing-use products (MPs) , end-use products (EPs) and
special local needs registrations (SLNs) , must submit the items
below for each product within 8 months of the date of issuance of
the RED:
a. Application for Reregistration (use EPA Form 8570-1).
Complete and sign the form. In Section II of that form, check the
box "Other" and insert the phrase "Application for Reregistration."
Use only an original application f,orm with a red identifier number
in the upper right-hand corner.
b. Five (5) copies of revised draft label and labeling.
Refer to the RED for labeling changes specific to the active
ingredient, follow the instructions in Section II I.e. of this
Handbook and refer to the Appendix of this Handbook for guidance on
current requirements for labels and labeling. If there are
ineligible uses on the label or labeling, you may delete such uses
and avoid all requirements and consequences which may be associated
with ineligible uses (e.g, generic data requirements, cancellation,
suspension, etc.) . If you delete certain uses now and those uses
become eligible for reregistration later, you must submit an
amendment application to add those uses back to the label.
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FIGURE 1. HOW AND WHEN TO RESPOND TO TEE REREGISTRATION
ELIGIBILITY DOCUMENT (RED) FOR MANUFACTURING USE
PRODUCTS (MPs), END-USE PRODUCTS (EPs) and SPECIAL
LOCAL NEEDS REGISTRATIONS (SLNs).
STEP 1: Are expedited label revisions required?
Yes
Submit application
and labels on
expedited schedule
specified in RED.
STEP 2: Are data required?
Yes
Submit forms within
90 days for generic
and product specific
data.
STEP 3:
No
NO
Are any of the uses on the label
eligible for reregistration?
Yes
Are any uses on the label
ineligible for reregistration?
Yes
Do you wish to
delete ineligible
uses from label?
No
For each HP & EF
& SLN <24c) submit
application within
8 months. If
the submission
is acceptable,
the label will be
stamped accepted
as an amendment.
No reregistration
will be issued.
Yes
For each HP & EP
t SLN (24c) submit
application within
8 months. If
the submission
is acceptable,
the label will be
stamped accepted
and a notice of
rere
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c. Product Specific Data. You must follow the instructions
in the Data Call-in Notice in tbe RED and in Section III of this
Handbook. Responses to the data call in are due within 90 days of
receipt of the RED and submission or citation of data is due within
8 months of the issuance of the RED.
d. Two (2) copies of the current Confidential Statement of
Formula (EPA Form 8570-4, revised February 85). Two completed and
signed CSF forms must be submitted for the basic formulation and
for each alternate formulation. If CSFs are not provided for the'
alternate formulas, they will not be reregistered and will no
longer be acceptable. The Appendix of this Handbook has specific
instructions for completing the CSF form.
e. Certification With Respect to Citation of Data (EPA Form
8570-31). This form must be completed, signed and submitted for
each product to assure that the data compensation provisions of
FIFRA are met,
B. When Ho Response is jteeded
If no uses of a pesticide are eligible for reregistration, it
is unlikely that you will be required to submit product specific
data or labeling. Uses of an active ingredient may be declared
ineligible for reregistration for two possible reasons:
—Available data indicate that one or more of the criteria for
an in-depth special review have been met;
—Additional generic data are required.
In the first instance, if the active ingredient is placed into
special review, reregistration activities associated with those
uses of the chemical are stopped until EPA makes a final
determination. At that time, EPA will indicate which uses may be
eligible for reregistration and which uses are to be cancelled. If
some or all of the previously ineligible uses become eligible for
reregistration, EPA will start the reregistration process for
products containing only eligible uses.
In the second instance, based upon the review of studies for
an active ingredient during reregistration, additional generic data
(e.g., second- or third-tier studies) may be needed (see the RED).
In such cases, the chemical's uses will not be eligible for
reregistration until the additional generic data have been
submitted to and reviewed and found acceptable by EPA. If the data
are reviewed and found to be acceptable, EPA will indicate which
uses will be eligible for reregistration and will initiate
reregistration of products containing previously ineligible uses.
If the data are not submitted, products containing the active
ingredient may be suspended.
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C. Where to Respond
By U.S. Mail:
Document Processing Desk (insert distribution code)
Office of Pesticide Programs (H7504C)
Environmental Protection Agency
401 M Street, s.w.
Washington, D.C. 20460-0001
By express mail or by hand delivery:
Document Processing Desk (insert distribution code)
Office of Pesticide Programs (H7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Highway
Arlington, VA 22202
These mailing addresses and the following distribution codes
must be used to assure the timely receipt and processing of your
submissions. Not using them may significantly delay the handling
of your submissions:
RED-SRRD-xxx (where xxx is the case code given on the front of
the RED)—use this distribution code for all responses pertaining
to or containing generic data. Such responses include the 90-day
response forms for generic data or hard copies of generic data.
RED-RD-PMxx (where xx is the Product Manager team number)—
use this distribution code for all responses pertaining to or
containing product specific data or labeling. Such responses would
include expedited labeling amendments, 90-day responses to product
specific data requirements, hard copies of product specific data
and applications for reregistration.
III. SUBMISSION OF DATA AND LABELS/LABELING
This section provides additional instructions concerning
responses required for generic data, product specific data and
labels/labeling.
A. Generic Data
During EPA's evaluation of an active ingredient for
reregistration, additional generic data requirements may be
identified that registrants must fulfill. In some instances these
data requirements would have to be satisfied before an active
ingredient or some of its uses could be declared eligible for
reregistration. In other cases, these new data requirements would
not affect the eligibility of the active ingredient, but would be
necessary to confirm EPA's assessment of that chemical.
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Any new data requirements and how they affect reregistration
eligibility of a chemical are discussed in the RED. If new generic
data requirements are imposed in a Data Dall-ln Notice in the RED,
registrants must respond as described in that Notice. The RED also
contains instructions for completing these forms, a citation of
EPA's legal authority for requiring the new data, a listing of
options available to registrants for satisfying the data
requirements and the name of the contact person for inquiries.
B. Product Specific Data
Product specific data may be required for the reregistration
of each pesticide product in three areas—product chemistry, acute
toxicity and efficacy.
1. Product Chemistry
Following are instructions for submitting product-specific
data and a discussion of EPA's policy on inert ingredients.
All data requirements for MPs, EPs and SLNs (24c's) are
specified in the Data Call-in Notice in the RED. In addition:
—If you cite data from another identical, registered
product, you must identify the EPA registration number of that
product.
—If the product-specific data submitted or cited do not
pertain to an identical formulation to the product submitted for
reregistration, then new product-specific data are required to be
submitted by the deadline specified in the Data Call-in Notice.
The only exception is for products which EPA. "groups" together a
being similar enough to depend on the same data. Such groupings
are discussed in the appendix to the RED (for acute toxicity
purposes, for example), if it was feasible to do so.
b. Inert Ingredients
EPA has implemented a strategy for regulating inert
ingredients which affects the reregistration of pesticide products.
This strategy, issued on April 22, 1987 (52 FR 13305-13309) and
updated on November 22, 1989 {54 FR 48314-48316), adopted certain
policies designed to reduce the potential for adverse effects from
pesticide products containing intentionally added inert
ingredients. EPA divided the known inert ingredients into four
categories:
--Inerts of toxicological concern (List 1) for which available
data demonstrate toxic effects of concern {includes about 50
chemicals) .
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—Potentially toxic inerts (List 2) for which only limited
data are available, but such data or the chemical structure suggest
the potential for toxicity (includes about 60 chemicals),
--Inerts of unknown toxicity (List 3) for which no data or
bases for suspecting toxic effects are available (includes up to
2,000 chemicals).
— Inerts of minimal concern (List 4) which are generally
regarded as innocuous (includes about 290 chemicals).
When a RED is issued and any uses of an active ingredient are
declared eligible for reregistration, all products containing that
active ingredient will be subject to reregistration. EPA will, as
part of the reregistration review, examine the inert ingredients of
each product prior to reregistration to ensure that they do not
present unreasonable risKs. In reviewing the product chemistry
data, EPA will identify List 1 inerts. EPA will continue to
encourage registrants to eliminate any List 1 inerts present.
Reregistration of products containing only List 2, 3 or 4 inerts
will be unaffected by the inerts strategy.
Consistent with the strategy on inerts, a product containing
a List 1 inert ingredient will nfit be reregistered until a full
risk assessment of the product has been conducted, based on the
data called in for that inert ingredient. However, the existing
registration of a product containing a List 1 inert will remain
valid as long as the product bears the required label warning and
is in compliance with any outstanding DCI, or other activity under
the inerts strategy.
Any product containing a List 2, 3 or 4 inert may. be
reregistered if it meets all other requirements for reregistration.
As the inerts strategy is implemented and data for the List 2 and
3 inerts are reviewed, EPA may move these inerts to the other
Lists If an inert were moved to List 1, products containing that
inert would become ineligible for reregistration. Inert
ingredients must also meet normal registration and tolerance
requirements, as applicable.
2, Acute Toxicity
The data call-in notice in the RED specifies the acute
toxicity data required for reregistration of each HP or EP. It
indicates whether any of the standard tests have been waived and,
if so, Why.
If feasible, EPA will "batch" products that are similar with
respect to their acute toxicity so that one set of tests can
support reregistration of each baatch of products. This approach
will impose the least amount of testing necessary to adequately
support the registration and labeling for pesticide products. The
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main benefits of this approach are to minimize the need for animal
testing, reduce the expense to registrants to generate the tests
and decrease the resources EPA must spend on reviewing data.
Registrants may contact other registrants with products in the same
"batch" to decide whether to provide or depend on one set of data;
alternatively, registrants may choose to conduct their own studies.
3. Product Performance
Consult the Data Call-in section of the RED to determine
whether Product Performance data are required for your product.
Product performance (efficacy) data are generated in studies
designed to document how candidate pesticide formulations perform
as pest control agents. These data include tests run to determine
whether a formulation is lethal to certain pest species, to
document the effectiveness of the formulation in controlling pest
species in actual use situations, and to determine whether certain
claims beyond mere control of a pest (e.g., "six-month residual
effect," "kills Warfarin resistant house mice," -etc.) are
justified.
EPA has standard protocols for certain efficacy tests. In
general, standard methods have been developed for tests needed to
substantiate claims that have been made frequently for pesticide
products. As the scope of potential pesticidal claims is extremely
broad, the Agency does not have standard methods for tests needed
to substantiate many pesticide claims, especially those that are
uncommon. The Product Performance Guidelines, Subdivision G, offer
general guidance for developing protocols for efficacy testing.
Proposed protocols should be submitted to EPA for review before
tests are initiated.
a. Efficacy Data Submission Waiver Policy
FIFRA gives the Administrator of EPA authority "to waive data
requirements pertaining to efficacy" but does not require that
efficacy data requirements be waived for any class of pesticide
product registered under Section 3 of the Act. As a matter of
policy, EPA does not require submission of efficacy data to support
many types of pesticidal claims but does require submission of such
data for certain types of claims. As noted in 4O CFR 158.640, this
waiver applies to the submission of efficacy data rather than to
the generation of efficacy data. EPA expects each registrant to
"ensure through testing that his products are efficacious when used
in accordance with commonly accepted pest control practices."
This general policy notwithstanding, EPA may, at any time,
require a registrant to submit efficacy data to support any claim
made for a product. EPA also may require that certain claims of
effectiveness be established before a Section 3 registration is
granted.
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10
b. Claims and Products for Which Efficacy Data Generally
Are Required
Submission of efficacy data at reregistration typically is
required for the following types of products:
1. products claimed to control microorganisms that
pose potential threats to public health;
2. products claimed to control vertebrate pests that
may directly or indirectly transmit diseases to
humans;
3. potentially very hazardous products for which EPA
determines that it is necessary to conduct a "risk-
benefits" analysis;
4. products of types for which EPA has reasons (e.g.,
consumer complaints, unlikely claims, unusual use
patterns, etc.) to question claims; and
C. Labels and_Labeling
To remain in compliance with FIFRA, the label and labeling of
each product must be revised to meet the requirements for
reregistration as described below, "Labeling" includes the
container label and -any written, printed or graphic matter that
accompanies the pesticide in U.S. commerce at any time (such as
technical bulletins, collateral labeling, etc.). Applications for
new uses or labeling changes that do not pertain to reregistration
must be filed separately from the application for reregistration
described in Step 3 earlier. Changes to labeling which must be
made for reregistration include, but are not limited to:
1. Labeling changes specified in the RED. Such changes may
include statements, on RESTRICTED USE, groundwater hazards,
protective clothing/equipment, endangered species, environmental
hazards, etc.
2. The format and content of labeling as described in 40 CFR
156.10. When further acute testing is needed, the currently
accepted precautionary statements will usually be retained until
testing is completed and the data are reviewed.
3. Labeling changes required by Pesticide Regulatory (PR)
Notices, regulations, regulatory decisions and policies issued by
EPA which are relevant to the pesticide. Your product's labeling
must reflect any applicable requirements which are in effect at the
time the RED is issued. Some existing notices are referred to in
Section B. of the Appendix.
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APPENDIX
A. confidential statement of Formula and instructions
B. Instructions for Label Contents
C. Sample Label Formats—General Use & Restricted Use
D. Label Regulations (40 CFR 156.10)
-------
-------
&EPA
United Slit** Environ menu I Protection Agency
OHic* of Peslicwrt Proflr»iti» (TS-767)
Ws sMngl o n. D C 2O460
Confidential Statement of Formula
. Name and Address of Applicant/Registrant tfnctud« ZIP Code)
3. product Kama
EPA USE ONLY
10. CwnpMiwn in Formulation (List« wrt»% intrmluffft
ime r/» taiiaulftiart. Cm commonly »ee»ptul cbarmctl
nwiM. Iffdf tame. »nd CAS numbtr.)
I I Basic Formulation
I I AlternatB Formulation
Page
2. Name and Address ol Producer (Include ZIP Code)
See Inslruclionson Back
4 fl«gillf*tion No./Fil» Symbol
T. Paumh/Gil o* Bulk D*ni!ty
11. Supplier Nim« ft AddrM*
5 EPA Product Mer/Team Mo.
8 pH
tl EPA Reg No
13. Each Componenl
ir Fofmulstion
a. Amount
6 Counity Where Formulated
9 Flash Point/Flame Extanaion
* by Wsighl
Uppti Limn b I
Pu'po«in
16. Typed Name of Approving Official
18 Signature of Approving Official
19. Title
ZO Prwne No. flnclutter A,t» Coast 21
EPA Form B570-4 (R«v. 2-B5) Previous editions are obsolaie.
Ortginat and itcond cftfly ro f PA.
Thudfopf to Applicant
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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
poundst 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.
n. The upper and lower certified limits for all active and
inert ingredients must follow the 40 CFR 158.175 instructions. An
explanation must be provided if the proposed limits are different
than standard certified limits.
n. When new CSFs are submitted and approved, all previously
submitted CSFs become obsolete for that specific formulation.
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B. INSTRUCTIONS FOR LABEL CONTENTS
40 CFR 156,10 and Pesticide Regulatory (P.R.) Notices require
that specific labeling statements appear at certain locations on
the label. The sample label formats in Appendix C show where these
statements are to be placed.
Item 1. PRODUCT NAME - The name, brand or trademark is required to
be located on the front panel, preferably centered in the upper
part of the panel. The name of a product will not be accepted if
it is false or misleading. [40 CFR 156.10(b) ]
Item 2. COMPANY NAME AND ADDRESS - The name and address of the
producer, registrant or person for whom the product is produced are
required on the label and should be located at the bottom of the
front panel or at the end of the label text. [40 CFR 156.10(c)]
Item 3. NET CONTENTS - A net contents statement is required on all
labels or on the container of the pesticide. The. preferred
location is the bottom of the front panel immediately above the
company name and address, or at the end of the label text. The net
contents must be expressed in the largest suitable unit, e.g., "1
pound 10 ounces" rather than "26 ounces." in addition to English
units, net contents may be expressed in metric units. [40 CFR
156.10{d)]
Item 4. EPA REGISTRATION NUMBER - The registration number assigned
to the pesticide product must appear on the label, preceded by the
phrase "EPA Registration No.," or "EPA Reg. No." The registration
number must be set in type of a size and style similar to other
print on that part of the label on which it appears and must run
parallel to it. The registration number and the required
identifying phrase must not appear in such a manner as to suggest
or imply recommendation or endorsement of the product by the
Agency. [40 CFR 156.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment number,
preceded by the phrase "EPA Est." is the final establishment at
which the product was produced, and may appear in any suitable
location on the label or immediate container. It must also appear
on the wrapper or outside container of the package if the EPA
establishment number on the immediate container cannot be clearly
read through such wrapper or container. [40 CFR 156.10(f)]
Item 6A. INGREDIENTS STATEMENT - An ingredients statement is
normally required on the front panel. The ingredients statement
must contain the name and percentage by weight of each active
ingredient and the total percentage by weight -of all inert
ingredients. The preferred location is immediately below the
product name. The ingredients statement must run parallel with,
and be clearly distinguished from, other text on the panel. It
must not be placed in the body of other text. [40 CFR 156.10(g)]
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricultural
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formulations, the pounds per gallon of active ingredient must be
indicated on the label. [40 CFR 156.10(h)(iv)]
Item 6C NAMES TO BE USED IN INGREDIENT STATEMENT - The acceptable
common "name, if there is one, shall be used, followed by the
chemical name. If no common name has been established, the
chemical name alone shall be used. Chemicals related to_the active
ingredient are allowed to be listed only, if efficacy data
supporting such claims are submitted or referenced. If such data
are provided, the related chemicals must be listed separately and
not as a portion of the active ingredient.
Item 6D. INERT INGREDIENTS RECLASSIFIED AS ACTIVE INGREDIENTS - If
EPA has reclassified chemicals from inert ingredient status to
active ingredient status, registrants of affected products must
change the ingredient statement accordingly (See 52 FR 13307-8,
April 22 1987). If such pesticides have food uses, tolerances
must either be established for such uses, or an exemption from the
requirement for tolerances must be obtained.
Item 6E. NOMINAL CONCENTRATION - The amount of active ingredient
declared in the ingredient statement must be the nominal
concentration of the product as defined in 40 CFR 158.153(1) and
described in P.R. Notice 91-2.
Item 7. WARNINGS AND PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label on Signal Word "Keep Out of Reach
Front Panel Minimum Type Size of Children
in fiouare Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 1S point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement "Keep Out
of Reach of Children" must be located on the front panel above the
signal word except where contact with children during distribution
or use is unlikely. [40 CFR 156.10(h)(1)(ii) J
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING, or
CAUTION) is required on the front panel immediately below the child
hazard warning statement. [40 CFR 156.10(h)(1)(i) ] .
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Item 7C, SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal, or
inhalation toxicity, the word "Poison" shall appear on the label in
red on a background of distinctly contrasting color and the skull
and crossbones shall appear in immediate proximity to the word
POISON. [40 CFR 156.10(h)(1)(i)].
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement of
practical treatment (first aid or other) shall appear on the label
of pesticide products in toxicity Categories I, II, and III. [40
CFR 156.10(h)(1)(iii) ]
Item 7E. REFERRAL STATEMENT - The statement "see Side (or Back)
Panel for Additional Precautionary statements" is required on the
front panel for all products, unless all required precautionary
statements appear on the front panel. [40 CFR 156.10(h)(1)(iii)].
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The precautionary
statements listed below must appear together on the label under the
heading "PRECAUTIONARY STATEMENTS." The preferred location is at
the top of the side or back panel preceding the directions for use,
and it is preferred that these statements be surrounded by a block
outline. Each of the three hazard warning statements must be
headed by the appropriate hazard title. [40 CFR 156.10(h)(2)]
Item BA. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a hazard
exists to humans or domestic animals, precautionary statements are
required indicating the particular hazard, the route(s) of exposure
and the precautions to be taken to avoid accident, injury or
damage. [40 CFR 156.10(h) (2) (i) ]
Item SB. ENVIRONMENTAL HAZARD - Where a hazard exists to non-
target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of the
hazard and the appropriate precautions to avoid potential accident,
injury, or damage. [40 CFR I56.10(h)(2)(ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY Precautionary
statements relating to flammability of a product are required to
appear on the label if it meets the criteria in the PHYS/CHEM
Labeling Appendix. The requirement is based on the results of the
flashpoint determinations and flame extension tests required to be
submitted for all products. These statements are to be located in
the side/back panel precautionary statements section, preceded by
the heading "Physical/Chemical Hazards." Note that no signal word
is used in conjunction with the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3(d) requires
that all pesticide formulations/uses be classified for either
general or restricted use. Products classified for restricted use
may be limited to use by certified applicators or persons under
their direct supervision (or may be subject to other restrictions
that may be imposed by regulation) . If your product has been
classified for restricted use, then these requirements apply;
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1. All'uses restricted. The following statements must be placed
in a black box at the top of the front panel of the label and
labeling:
a. The statement "Restricted Use Pesticide" must appear at
the top of the front panel of the label. The statement
must be set in type of the same minimum size as required
for human hazard signal word [see table in 40 CFR
156.10(h)(1)(iv) ] . No statements of any kind may appear
above this RUP statement.
b. The reason.for the the restricted use classification must
appear below the RUP statement. The RED will prescribe
this statement.
c. A summary statement of the terms of restriction must
appear directly below this reason statement on the front
panel. If use is restricted to certified applicators,
the following statement is required: "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." The RED
will specify what statement must be used.
2. Some but not all uses restricted. If the RED states that some
uses are classified for restricted use, and some are
unclassified, several courses of action are available:
a. You may label the product for Restricted use. If you do
so, you may include on the label uses that are
unrestricted, but you may not distinguish them on the
label as being unrestricted.
b. You may delete all restricted uses from your label and
submit draft labeling bearing only unrestricted uses.
c. You may "split" your registration, i.e., register two
separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications Should be submitted
simultaneously. Note that the products will be assigned
separate registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the misuse
statement, "It is a violation of Federal law to use this product in
a manner inconsistent with its labeling." This statement appears
at the beginning of the directions for use, directly beneath the
heading of that section.
Item IDA. REENTRY STATEMENT - If a restricted entry interval (REI)
has been established by the Agency, it must be included on the
label. Additional worker protection statements may be required in
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accordance with PR Notice 83-2, March 29, 1983.
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are required to
bear storage and disposal statements. These statements are
developed for specific containers, sizes, and chemical content.
These instructions must be grouped and appear under the heading
"Storage and Disposal" in the directions for use. This heading
must be set in the same type sizes as required for the child hazard
warning. Refer to P.R. Notices 83-3 and 84-1 to determine the
storage and disposal instructions appropriate for your products.
Item IOC. DIRECTIONS FOR USE - Directions for use must be stated
in terms which can be easily read and understood by the average
person likely to use or to supervise the use of the pesticide.
When followed, directions must be adequate to protect the public
from fraud and from personal injury and to prevent unreasonable
adverse effects on the environment. [40 CFR 156.10(i)(2)]
COLLATERAL LABELING
Bulletins, leaflets, circulars, brochures, data sheets, flyers, or
other written or graphic printed matter which is referred to on the
label or which is to accompany the product are termed collateral
labeling. Such labeling may not bear claims or representations
that differ in substance from those accepted in connection with
registration of the product. Collateral labeling must be made part
of the response to the RED and submitted for review.
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LABEL FORMAT FOR UNCLASSIFIED PRODUCTS
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LABEL FORMAT FOR PRODUCTS CLASSIFIED FOR RESTRICTED UZE
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Environmental Protection Agency
submitter has asserted a confidential
information claim concerning
the material)
<5) A copy of each document, propos-
al or other item of written material
concerning the Registration Standard
provided by the Agency to any person
or party outside of government
(within 15 working days after the Item
is made available to such person or
party).
(6) A copy of the Registration Stand-
ard;
(7) With respect to a Registration
Standard for which the Agency has
determined that a substantially com-
plete chronic health and teratology
data base exists, a copy of the FEDERAL
REGISTER notice concerning availabil-
ity of a proposed Registration Stand-
ard, and a copy of each comment re-
ceived in response to that notice
(within 10 working days after receipt
by the Agency, or 15 working days if
the submitter has asserted a confiden-
tial business Information claim con-
cerning the material).
(8) A copy of the FEDERAL REGISTER
notice announcing the issuance of the
Registration Standard (within 10
working days after the publication of
the notice).
(c) Index of the docket. The Agency
will establish and keep current an
index to the docket for each Registra-
tion Standard. The index will include,
but is not limited to:
(1) A list of each meeting between
the Agency and any person or party
outside of government, containing the
date and subject of the meeting, the
names of participants and the name of
the person requesting the meeting.
(2) A list of each document in the
docket by title, source or recipient(s),
and the date the document was re-
ceived or provided by the Agency.
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§ 156.10
lations in this Part. The contents of a
label must show clearly and promi-
nently the following:
(1) The name, brand, or trademark
under which the product Is sold as pre-
scribed in paragraph (b) of this sec-
(II) The name and address of the
producer, registrant, or person for
whom produced as prescribed in para-
graph (c) of this section;
The product registration
number as prescribed in paragraph (e)
of this section;
(v) The producing establishment
number as prescribed in paragraph (f >
of this section;
(vi) An ingredient statement as pre-
scribed in paragraph (g) of this sec-
tion: , .
(vii) Warning or precautionary state-
ments as prescribed in paragraph th)
of this section;
(vlii) The directions for use as pre-
scribed in paragraph (i) of this section;
and
(ix) The use classification(s) as pre-
scribed in paragraph (j) of this section.
(2) Prominence and legibility. (1) All
words, statements, graphic representa-
tions, designs or other information re-
quired on the labeling by the Act or
the regulations in this part must be
clearly legible to a person with normal
vision, and must be placed with such
conspicuousness (as compared with
other words, statements, designs, or
graphic matter on the labeling) and
expressed in such terms as to render it
likely to be read and understood by
the ordinary individual under custom-
-ary conditions of purchase and use.
(11) All required label text must:
(A) Be set to 6-polnt or larger type;
(B) Appear on a clear contrasting
background: and
(C) Not be obscured or crowded.
(3) L&ngv> to be wed All required
label or labeling text shall appear In
the English language. However, the
Agency may require or the applicant
may propose additional text in other
languages as is considered necessary to
protect the public. When additional
text in another language is necessary,
all labeling requirements will be ap-
plied equally to both the English and
40 CFR Ch. I (7-1-89 Edition)
other-language versions of the label-
ing.
(4) Placement of Label-d) General,
The label shall appear on or be secure-
ly attached to the immediate contain-
er of the pesticide product. For pur-
poses of this Section, and the tnia-
branding provisions of the Act, "se-
curely attached" shall mean that a
label can reasonably be expected to
remain affixed during the foreseeable
conditions and period of use. If the im-
mediate container is enclosed within a
wrapper or outside container through
which the label cannot be clearly read,
the label must also be securely at-
tached to such outside wrapper or con-
tainer. if it is a part of the package as
customarily distributed or sold.
(il) Tank cars and other bulk con-
tainers— < A) Transportation, While a
pesticide product is in transit, the ap-
propriate provisions of 49 CFR Parts
170-189, concerning the transportation
of hazardous materials, and specifical-
ly those provisions concerning the la-
beling, marking and placarding of haz-
ardous materials and the vehicles car-
rying them, define the basic Federal
requirements. In addition, when any
registered" pesticide product is trans-
ported In a tank car, tank truck or
other mobile or portable bulk contain-
er, a copy of the accepted label must
be attached to the shipping papers,
and left with the consignee at the time
of delivery.
(B) Storage. When pesticide prod-
ucts are stored in bulk containers,
whether mobile or stationary, which
remain in the custody ol the user, a
copy of the label of labeling, including
aU appropriate directions for use, shall
be securely attached to the container
in the immediate vicinity of the dis-
charge control valve.
(5) False or misleading statements.
Pursuant to section 2(q)(lXA> of the
Act, a pesticide or a device declared
subject to the Act pursuant to
5 153.240. is misbranded if Its labeling
Is false or misleading in any particular
including both pestlcidal and non-pes-
tlcidal claims. Examples of statements
or representations in the labeling
which constitute misbranding include;
(i) A false or misleading statement
concerning the composition of the
product;
76
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Protection Agency
(ID A false or misleading statement
concerning the effectiveness of the
product as a pesticide or device;
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§156.10
tent of the packages In a shipment fall
suggest or imply recommendation
or endorsement of the product by the
Agency*
(ft Producing establishments regis-
tration number. The producing estab-
lishment registration number preced-
ed by the phrase "EPA Est.", of the
final establishment at which the prod-
uct was produced may appear In any
suitable location on the label or imme-
diate container. It must appear on the
wrapper or outside container of the
package if the EPA establishment reg-
istration number on the immediate
container cannot be clearly read
through such wrapper or container.
(g) Ingredient statement— <1) Gener-
al. The label of each pesticide product
must bear a statement which contains
the name and percentage by weight of
each active ingredient, the total per-
centage by weight of all inert ingredi-
ents; and if the pesticide contains ar-
senic in any form, a statement of the
percentages of total and water-soluble
arsenic calculated as elemental ar-
senic. The active ingredients must be
designated by the term "active ingredi-
ents" and the inert Ingredients by the
term "Inert Ingredients," or the singu-
lar forms of these terms when appro-
priate. Both terms shall be in the
same type size, be aligned to the same
margin and be equally prominent. The
statement "Inert Ingredients, none" is
not required for pesticides which con-
tain 100 percent active ingredients.
Unless the Ingredient statement is a
complete analysis of the pesticide, the
term "analysis" shall not be used as a
heading for the Ingredient statement.
(2) Position of ingredient statement
(1) The Ingredient statement is nor-
mally required on the front panel of
40 CFR Ch. I (7-1-89 Edition)
label If there is an outside con-
tainer or wrapper through which the
ingredient statement cannot be clearly
read, the ingredient statement must
also 'appear on such outside container
or wrapper. If the size or form of the
package makes it impracticable to
place the ingredient statement on the
front panel of the label, permission
may be granted for the ingredient
statement to appear elsewhere.
(ii) The text of the Ingredient state-
ment must run parallel with other
text on the panel on which it appears,
and must be clearly distinguishable
from and must not be placed in the
body of other text.
(3) Names to be used in ingredient
statement. The name used for each in-
gredient shall be the accepted
common name, if there is one, fol-
lowed by the chemical name. The
common name may be used alone only
if it is well known. If no common name
has been established, the chemical
name alone shall be used. In no case
will the use of a trademark or proprie-
tary name be permitted unless such
name has been accepted as a common
name by. the Administrator under the
authority of section 25(0(8).
(4) Statements of percentages. The
percentages of ingredients shall be
stated in terms of weight-to-weight.
The sum of percentages of the active
and the inert Ingredients shall be 100.
Percentages shall not be expressed by
a range of values such as "22-25%." If
the uses of the pesticide product are
expressed as weight of active Ingredi-
ent per unit area, a statement of the
weight of active ingredient per unit
volume of the pesticide formulation
shall also appear in the ingredient
statement.
(5) Accuracy of stated percentages.
The percentages given shall be as pre-
cise as possible reflecting good manu-
facturing practice. If there may be un-
avoidable variation between manufac-
turing batches, the value stated for
each active ingredient shall be the
lowest percentage which may be
present.
(6) Deterioration. Pesticides which
change in chemical composition sig-
nificantly must meet the following la-
beling requirements:
78
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cnv|ronin*ntal Protection Agoncy
,n in cases where it is determined
hat a pesticide .formulation changes
hemlca* composition significantly,
me product must bear the following
tktement in a prominent position on
the label: "Not for sale or use after
rdatel."
Use of signal words. Use of any
signal word(s) associated with a higher
Toxicity Category is not permitted
except when the Agency determines
that such labeling is necessary to pre-
vent unreasonable adverse effects on
man or the environment. In no case
shall more than one human hazard
signal word appear on the front panel
of a label,
(il) Child hazard warning. Every pes-
ticide product laoel shall bear on the
front panel the statement "keep out of
reach of children," Only in cases
where the likelihood of contact with
children during distribution, market-
ing, storage or use is demonstrated by
the applicant to be extremely remote,
or if the nature of the pesticide is such
79
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I 156.10
that It is approved lor use on infants
or small children, may the Administra-
tor waive this requirement.
(ill) Statement of practical treat-
m*n«—(A) Toxicity Category I. A
statement of practical treatment {first
aid or other) shall appear on the front
panel of the label of all pesticides fall-
ing into Toxicity Category I on the
basis of oral, inhalation or dermal tox-
leity. The Agency may. however,
permit reasonable variations in the
placement of the statement of practi-
cal treatment is some reference such
as "See statement of practical treat-
ment on back panel" appears on the
front panel near the word "Poison"
and the skull and crossbones.
CB) Otter toxitrity categories. The
statement of practical treatment is not
required on the front panel except as
described in paragraph (hXIKiilXA) of
this section. The applicant may, how-
ever, include such a front panel state-
ment at his option. Statements of
practical treatment are, however, re-
quired elsewhere on the label in
accord with paragraph (h)(2> of this
section if they do not appear on the
front panel.
(iv) Placement and prominence. All
the require front panel warning state-
ments shall be grouped together on
the label, and shall appear with suffi-
cient prominence relative to other
front panel text and graphic material
to make them unlikely to be over-
looked under customary conditions of
purchase and use. The following table
shows the minimum type size requlre-
40 CFR Ch. 1 (7-1-S9 Edition)
menu for the front panel warning
statements on various sizes of labels:
Size of IUM< front panel in tquare
incnee
$ •ml under
Above 5 to 10
Above 10 to 15
Above 15 to 30
Over 30.
Pot
Requved
aignal
wont, ill
capital!
6
10
12
14
18
rm
"Keepow
Of react! w
Chadren"
15
(2) Other required warnings and pre-
cautionary statements. The warnings
and precautionary statements as re-
quired below shall appear together on
the label under the general heading
"Precautionary Statements" and
under appropriate subheadings of
"Hazard to Humans and Domestic Ani-
mals," "Environmental Hazard" and
"'Physical or Chemical Hazard."
(I) Hazard to humans and domestic
animals. (A) Where a hazard exists to
humans or domestic animals, precau-
tionary statements are required indi-
cating the particular hazard, the
routets) of exposure and the precau-
tions to be taken to avoid accident.
injury or damage. The precautionary
paragraph shall be immediately pre-
ceded by the appropriate hazard signal
word.
(B) The following table depicts typi-
cal precautionary statements. These
statements must be modified,or ex-
panded to reflect specific hazards.
Toncrty
category
Precautionary statement* by tenacity category
Oral, inhalation, or dermal toncrty
Skin and eye toeal effect*
II
III.
IV
Fatal (powsoou*) « (wallowed linhalad or
through akin). Do not breathe vapor toutt or ipray
mot]. Do not get in ayea. on ikin. or on dotting
[Front panel atawmeni of practical treatrnent re-
quired.].
May be fatal II twaHowed [inhaled or abaorbed
through tht it*]. Do not bmthf vipon [duft or
•pray miatl. Do not gel in evea, on akin, or on
cfcxriing tAperopriate flnt aid etatementa rvquired.J.
Harmful ti twaHowed [inhaled or abaorbed through the
akin]. Avoid breathing vapor* [duat or apny rrrtt).
Avoid eomact wtth aWn [eye* or dothing]. [Appro-
priate firat aid atatement required, ].
[No pracaudonary natementt requrad.1
eye and itin damage [or tfcm
irritation}. Do not get in evea. on Dun. or on
clothing. Wear aoojte* or lace ahietd and rubber
gtovee when nandhng. Harmful or fatal if (wallowed.
[Appropriate firr aid atatcmam required-J
Cauaea ay* (and akin] irritation. Do not get in eye*.
on Hw, or on dotting. Harmful if iwutowtd. [A>
propnata flnjt aid •tatemafit raquired,]
Avoid contact with thin, ty« or clothing. In eaat of
contact immediately flush ayat or lion with plenty of
water. Gat medical attention ff irritation penMts.
[No precautionary atttamanta required,]
80
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.ronrB«ntal Protection Agoncy
„. Environmental hazards. Where a
( exists to non target organisms
g humans and domestic ani-
recautionary statements are re-
stating the nature of the
and tne aPProPriate precau-
jo avoid potential accident,
or damage. Examples of the
statements and the circum-
under which they are required
if ft Pesticide intended for out-
use contains an active ingredient
a mammalian acute oral LD» of
or less, the statement "This Pesti-
cide is Toxic to Wildlife" is required.
(B) If » pesticide intended lor out-
door use contains an active ingredient
.ritn a fish acute LC*. of 1 ppm or less,
the statement "This Pesticide Is Toxic
to Pish" is required.
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§ 156.10
(B> The label bears a reference to
the directions for use in accompanying
leaflets or circulars, such as "See di-
rections in the enclosed circular:" and
(C) The Administrator determines
that it is not necessary for such direc-
tions to appear on the label,
(ili) Exceptions to requirement for
direction for use— The site(s) of application, as for
example the crops, animals, areas, or
objects to be treated.
(iv) The target pest(s) associated
with each site.
(v) The dosage rate associated with
each site and pest.
cvi) The method of application, in-
cluding instructions for dilution. If re-
quired, and type(s) of application ap-
paratus or equipment required.
(vil) The frequency and timing of ap-
plications necessary to obtain effective
results without causing unreasonable
adverse effects on the environment.
(vlli) Specific limitations on reentry
to areas where the pesticide has been
applied, meeting the requirements
concerning reentry provided by 40
CFR Part 170.
(be) Specific directions concerning
the storage and disposal of the pesti-
cide and its container, meeting the re-
quirements of 40 CFR Part 165. These
instructions shall be grouped and
appear under the heading "Storage
and Disposal." This heading must b«
set in type of the same minimum siz*»
as required for the child hazard warn-
ing. (See Table In § 162.10(hKl)Clv))
82
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Protection Agtney
Any limitations or restrictions on
ired to prevent unreasonable
ve effects, such as:
/A) Required intervals between ap-
and harvest of food or feed
> Rotational crop restrictions.
) Warnings as required against use
Certain crops, animals, objects, or
adjacent to certain areas.
[Reserved!
F°r restricted use pesticides, a
nt that the pesticide may be
fto under the direct supervision of
* certified applicator who is not phys-
ically present at the site of application
but nonetheless available to the
person applying the pesticide, unless
the Agency has determined that the
pesticide may only be applied under
the direct supervision of a certified ap-
plicator who is physically present.
except that, if a product
has both restricted use(s) and general
use
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APPENDIX F
Generic Data Call-in
78
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
DATA CALL-IN NOTICE
OFFICE OF
CERTIFIED MAIL "WI ~" '^^U PREVENTION. PESTICIDES AND
TOXIC SUBSTANCES
NOV261993
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide
products containing the active ingredient identified in
Attachment A of this Not ice, the Data__Ca_ll-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 A through F; or
2. why you believe you are exempt from the requirements
listed in this Notice and in Attachment C, Requirements
Status and Registrants 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 B, Data Call-in Response Form, as well as a
list of all registrants who were sent this Notice (Attachment D) .
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 (expiration date 3-31-96).
Recycled/Recyclable
Printed with Soy/Canola Ink on paper that
contains at least 50% recycled fiber
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This Notice is divided into six sections and six
Attachments. The Notice itself contains information and
instructions applicable to all Data Call-in Notices. The
Attachments contain specific chemical information and
instructions. The six sections of the Notice are:
Section I - Why You Are Receiving This Notice
Section II - Data Required By This Notice
Section III - Compliance With Requirements Of This
Notice
Section IV - Consequences Of Failure To Comply With
This Notice
Section V - Registrants' Obligation To Report
Possible Unreasonable Adverse Effects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
Attachment A - Data Call-in Chemical Status Sheet
Attachment B - Data Call-in Response Form
Attachment C - Requirements Status And Registrant's Response
Form
Attachment D - List Of All Registrants Sent This Data
Call-in Notice
Attachment E - EPA Acceptance Criteria
Attachment F - Cost Share and Data Compensation Forms
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active
ingredient and reevaluated the data needed to support continued
registration of the subject active ingredient. This reevaluation
identified additional data necessary to assess the health and
safety of the continued use of products containing this active
ingredient. You have been sent this Notice because you have
product(s) containing the subject active ingredient.
SECTION II. DATA REQUIRED BY THIS NOTICE
II-A. DATA REQUIRED
The data required by this Notice are specified in
Attachment C, Requirements Status and Registrant's ResponseJForm.
Depending on the results of the studies required in this Notice,
additional 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 Attachment C, Requirements Status
and Registrant's Response Form, within the timeframes provided.
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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 {tel: 703-487-4650).
Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if the OECD-
recommended test standards conform to those specified in the
Pesticide Data Requirements regulation (40 CFR § 158.70). When
using the OECD protocols, they should be modified as appropriate so
that the data generated by the study will satisfy the requirements
of 40 CFR § 158. Normally, the Agency will not extend deadlines
for complying with data requirements when the studies were not
conducted in accordance with acceptable standards. The OECD
protocols are available from OECD, 1750 Pennsylvania Avenue N.W. ,
Washington, D.C. 20006.
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 160.3(a) (6) ].
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3fc)f21fB) NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-In does not in
any way supersede or change the requirements of any previous Data
Call—Infsi, 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
III-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice
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.
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III-B. OPTIOHS FOR RESPONDING TO THE AGENCY
The options for responding to this Notice are: 1) voluntary
cancellation, 2) delete use(s), (3) claim generic data exemption,
(4) agree to satisfy the data requirements imposed by this Notice
or (5) request a data waiver fa).
A discussion of how to respond if you chose 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 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.
There are two forms that accompany this Notice of which,
depending upon your response, one or both must be used in your
response to the Agency. These forms are the Data-Call-in Response
Form. Attachment B and the Requirements Status and Registrant's
Response Form. Attachment C. The Data Call-in Response Form must be
submitted as part of every response to this Notice. 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
identified in Attachment A.
l. Voluntary Cancellation - You may avoid the requirements of
this Notice by requesting voluntary cancellation of your product(s)
containing the active ingredient that is the subject of this
Notice. If you wish to voluntarily cancel your product, you must
submit a completed Data Call-In Response Form, indicating your
election of this option. Voluntary cancellation is item number 5
on the Data Call-In Response Form. If you choose this option, this
is the only form that you are required to complete.
If you chose to voluntarily cancel your product, further sale
and distribution of your product after the effective date of
cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in section IV-c,
2. 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, 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 on the Requirements Status and Registrant's Response Form.
-------
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 and
Emergency Response Branch, Registration Division, (703) 557-2126.
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 9O day response, must bear an amended label.
3. 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 gualify 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:
a. 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;
b. 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
c. 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 B 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 product specific
data.
If you are granted a Generic Data Exemption, you rely on the
efforts of other persons to provide the Agency with the required
data. If the registrant(s) who have committed to generate and
submit the required data fail to take appropriate steps to meet the
requirements or are no longer in compliance with this Data Call-In
Notice, the Agency will consider that both they and you are not in
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.
4. Satisfying the Data Requirements of this Notice There are
various options available to satisfy the data requirements of this
Notice. These options are discussed in Section III-C of this
Notice and comprise options 1 through 6 on the Requirements Status
and Registrant's Response Form and option 6b and 7 on the Data
Call-in Response Form. If you choose option 6b or 7, you must
submit both forms as well as any other information/data pertaining
to the option chosen to address the data reguirement.
5. Request for Data Waivers. Data waivers are discussed in
Section III-D of this Notice and are covered by options 8 and 9 on
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.
III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-in Response Form that you
agree to satisfy the data requirements (i.e. you select option 6b
and/or 7), 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 Registrants 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:
(l) I will generate and submit data within the specified
timeframe (Developing Data)
{2} I have entered into an agreement with one or more
registrants to develop data jointly (Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been
submitted previously to the Agency by anyone (Submitting
an Existing Study)
(5) I am submitting or citing data to upgrade a study
classified by EPA as partially acceptable and upgradeable
(Upgrading a Study)
(6) I am citing an existing study that EPA has classified as
acceptable or an existing study that has been submitted
but not reviewed by the Agency (Citing an Existing Study)
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Option 1. Developing Data — If you choose to develop the
required data it must be in conformance with Agency deadlines and
with other Agency requirements as referenced herein and in the
attachments. All data generated and submitted must comply with the
Good Laboratory Practice (GLP) rule (40 CFR Part 160), be conducted
according to the Pesticide Assessment Guidelines (PAG), and be in
conformance with the requirements of PR Notice 86-5. In addition,
certain studies require Agency approval of test protocols in
advance of study initiation. Those studies for which a protocol
must be submitted have been identified in the Requirements status
and Registrant's Response Form and/or footnotes to the form. If
you wish to use a protocol which differs from the options discussed
in Section II-C of this Notice, you must submit a detailed
description of the proposed protocol and your reason for wishing to
use it. The Agency may choose to reject a protocol not specified
in Section II-C. If the Agency rejects your protocol you will be
notified in writing, however, you should be aware that rejection of
a proposed protocol will not be a basis for extending the deadline
for submission of data,
A progress report must be submitted for each study within 90
days from the date you are required to commit to generate or
undertake some other means to address that study requirement, such
as making an offer to cost share or agreeing to share in the cost
of developing that study. A 90-day progress report must be
submitted for all studies. 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
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which includes: (1) a detailed description of the expected
difficulty and (2) a proposed schedule including alternative dates
for meeting such requirements on a step-by-step basis. You must
explain any technical or laboratory difficulties and provide
documentation from the laboratory performing the testing. While
EPA is considering your request, the original deadline remains.
The Agency will respond to your request in writing. If EPA does
not grant your request, the original deadline remains. Normally,
extensions can be requested only in cases of extraordinary testing
problems beyond the expectation or control of the registrant.
Extensions will not be given in submitting the 90-day responses.
Extensions will not be considered if the request for extension is
not made in a timely fashion; in no event shall an extension
request be considered if it is submitted at or after the lapse of
the subject deadline.
Option 2. Agreement to Share in Cost to Develop Data — If
you choose to enter into an agreement to share in the cost of
producing the required data but will not be submitting the data
yourself, you must provide the name of the registrant who will be
submitting the data. You must also provide EPA with documentary
evidence that an agreement has been formed. Such evidence may be
your letter offering to join in an agreement and the other
registrant's acceptance of your offer, or a written statement by
the parties that an agreement exists. The agreement to produce the
data need not specify all of the terms of the final arrangement
between the parties or the mechanism to resolve the terms. Section
3(c) (2) (B) provides that if the parties cannot resolve the terms of
the agreement they may resolve their differences through binding
arbitration.
Option 3. Offer to Share in the Cost of Data Development — If
you have made an offer to pay in an attempt to enter into an
agreement or amend an existing agreement to meet the requirements
of this Notice and have been unsuccessful, you may request EPA (by
selecting this option) to exercise its discretion not to suspend
your registration(s) , although you do not comply with the data
submission requirements of this Notice. EPA has determined that as
a general policy, absent other relevant considerations, it will not
suspend the registration of a product of a registrant who has in
good faith sought and continues to seek to enter into a joint data
development/cost sharing program, but the other registrant(s)
developing the data has refused to accept your 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 E. In addition, you must demonstrate that the
other registrant to whom the offer was made has not accepted your
offer to enter into a costsharing agreement by including a copy of
your offer and proof of the other registrant's receipt of that
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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 or failing agreement to
be bound by binding arbitration as provided by FIFRA section
3(c)(2)(E)(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-tin. Response Form and a Requirements Status and
Registrant's Response Form committing to develop and submit the
data required by this Notice.
In order for you to avoid suspension under this option, you
may not withdraw your offer to share in the burdens 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 will normally be subject to
initiation of suspension proceedings, unless you commit to submit,
and do submit the reguired 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
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 16O. As stated in 40 CFR 160.3 (j)
11 '[r]aw data' means any laboratory worksheets, records,
memoranda, notes, or exact copies thereof, that are the result
of original observations and activities of a study and are
necessary for the reconstruction and evaluation of the report
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of that study. In the event that exact transcripts of raw
data have been prepared (e.g., tapes which have been
transcribed verbatim, dated, and verified accurate by
signature), the exact copy or exact transcript may be
substituted for the original source as raw data. 'Raw data'
may include photographs, microfilm or microfiche copies,
computer printouts, magnetic media, including dictated
observations, and recorded data from automated instruments."
The term "specimens", according to 40 CFR 160.3 (k) , ineans "any
material derived from a test system for examination or
analysis."
b. Health and safety studies completed after May 1984 must
also contain all GLP-required quality assurance and quality
control information, pursuant to the requirements of 40 CFR
Part 160. Registrants must also 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 are usually 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
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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 reguired by PR Notice 86-5.
Option 5i 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
guestions regarding the classification of a study or whether a
study may be upgraded, call or write the contact person listed in
Attachment A. 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 should also be used to cite data that has been
previously submitted to upgrade a study, but has not yet been
reviewed by the Agency. You must provide the MRID number of the
data submission as well as the MRID number of the study being
upgraded.
The criteria for submitting an existing study, as specified in
Option 4 above, apply to all data submissions intended to upgrade
studies. Additionally your submission of data intended to upgrade
studies must be accompanied by a certification that you comply with
each of those criteria as well as a certification regarding
protocol compliance with Agency requirements.
Option 6. Citing Existing Studies — If you choose to cite a
study that has been previously submitted to EPA, that study must
have been previously classified by EPA as acceptable or it must be
a study which has not yet been reviewed by the Agency. Acceptable
toxicology studies generally will have been classified as "core-
guideline" or "core minimum." For ecological effects studies, the
classification generally would be a rating of "core." For all
other disciplines the classification would be "acceptable." With
respect to any studies for which you wish to select this option you
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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.
III-D REQUESTS FOR DATA WAIVERS
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 inapplicable and do not apply to your product.
1. Low Volume/Minor Use Waiver — Option 8 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 as low volume pesticides only those active
ingredients whose total production volume for all pesticide
registrants is small. In determining whether to grant a low
volume, minor use waiver the Agency will consider the extent,
pattern and volume of use, the economic incentive to conduct the
testing, the importance of the pesticide, and the exposure and risk
from use of the pesticide. If an active ingredient is used for
both high volume and low volume uses, a low volume exemption will
not be approved. If all uses of an active ingredient are low
volume and the combined volumes for all uses are also low, then an
exemption may be granted, depending on review of other information
outlined below. An exemption will not be granted if any registrant
of the active ingredient elects to conduct the testing. Any
registrant receiving a low volume minor use waiver must remain
within the sales figures in their forecast supporting the waiver
request in order to remain qualified for such waiver. If granted a
waiver, a registrant will be required, as a condition of the
waiver, to submit annual sales reports. The Agency will respond to
requests for waivers in writing.
To apply for a low volume, minor use waiver, you must submit
the following information, as applicable to your productfs), as
part of your 90-day response to this Notice:
a. (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.
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(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.
b. 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.
c. Total indirect production cost (e.g. plant overhead,
amortized plant and equipment) charged to product(sj
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.
d. (i) . 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
onducting the testing needed to fulfill each of
these data requirements.
(ii). 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.
e. For each of the next ten years, a year-by-year fore- cast
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.
f. 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
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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.
2. Request for Waiver of Data — Option 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 corresponding use is no longer registered or the
requirement is inappropriate. You must submit a rationale
explaining why you believe the data requirements should not apply.
You must also 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 do
not apply 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 vour product(s). vou 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.
IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products
subject to this Notice due to failure by a registrant to comply
with the requirements of this Data Call-in Notice, pursuant to
FIFRA section 3fc)(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:
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1. Failure to respond as required by this Notice within
9O days of your receipt of this Notice,
2. Failure to submit on the required schedule an acceptable
proposed or final protocol when such is required to be
submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate
progress report on a study as required by this Notice.
4. Failure to submit on the required schedule acceptable
data as required by this Notice.
5. Failure to take a required action or submit adequate
information pertaining to any option chosen to address the
data requirements (e.g., any required action or information
pertaining to submission or citation of existing studies or
offers, arrangements, or arbitration on the sharing of costs
or the formation of Task Forces, failure to comply with the
terms of an agreement or arbitration concerning joint data
development or failure to comply with any terms of a data
waiver).
6. Failure to submit supportable certifications as to the
conditions of submitted studies, as required by Section III-C
of this Notice.
7. Withdrawal of an offer to share in the cost of developing
required data.
8. Failure of the registrant to whom you have tendered an
offer to share in the cost of developing data and provided
proof of the registrant's receipt of such offer or failure of
a registrant on whom you rely for a generic data exemption
either to:
a. inform EPA of intent to develop and submit the data
required by this Notice on a Data Call-in Response Form
and a Requirements Status and Registrant's Response Form;
t>. fulfill the commitment to develop and submit the data
as required by this Notice; or
c. otherwise take appropriate steps to meet the
requirements stated in this Notice,
unless you commit to submit and do submit the required data in
the specified time frame.
9. Failure to take any required or appropriate steps, not
mentioned above, at any time following the issuance of this
Notice.
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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
submi s s ion requ irement.
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 would generally 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 must also explain why an "existing
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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 case-by-
case basis.
Requests for voluntary cancellation received after the 90 day
response period required by this Notice will not result in the
Agency granting any additional time to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was
due unless you demonstrate to the Agency that you are in full
compliance with all Agency requirements, including the requirements
of this Notice. For example, if you decide to voluntarily cancel
your registration six months before a 3 year study is scheduled to
be submitted, all progress reports and other information necessary
to establish that you have been conducting the study in an
acceptable and good faith manner must have been submitted to the
Agency, before EPA will consider granting an existing stocks
provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(2) states
that if at any time after a pesticide is registered a registrant
has additional factual information regarding unreasonable adverse
effects on the environment by the pesticide, the registrant shall
submit the information to the Agency. Registrants must notify the
Agency of any factual information they have, from whatever source,
including but not limited to interim or preliminary results of
studies, regarding unreasonable adverse effects on man or the
environment. This requirement continues as long as the products
are registered by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and
procedures established by this Notice, call the contact person
listed in Attachment A, the Data call-in chemical status sheet.
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All responses to this Notice (other than voluntary
cancellation requests and generic data exemption claims) must
include a completed Data Call-In Response Form (Attachment B) and a
completed Requirements Status and Registrant's Response Form
(Attachment C) and any other documents required by this Notice, and
should be submitted to the contact person identified in Attachment
A. If the voluntary cancellation or generic data exemption option
is chosen, only the Data Call-In Response Form need be submitted.
The Office of Compliance Monitoring (OCM) of the Office of
Pesticides and Toxic Substances (OPTS), EPA, will be monitoring the
data being generated in response to this Notice.
Sincerely yours,
~ /
Daniel M. Barolo, Dijzector
Special Review and
Reregistration Division
Attachments
A - Data Call-in Chemical Status Sheet
B - Data Ca11-In Response Form
C - Requirements Status and Registrants
Response Form
D - List of Registrants Receiving This Notice
E - EPA Acceptance Criteria
F - Cost Share and Data Compensation Forms
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ATTACHMENT A
Generic DCI Chemical Status Sheet
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BUTYLATE: DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Call-In Notice because you have products
containing butylate.
This Generic Data Call-in Chemical Status Sheet, contains an overview of data required
by this notice, and point of contact for inquiries pertaining to the reregistration of butylate. 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 B), (3) the Requirements Status and Registrant's
Response Form (Attachment C), (4) a list of registrants subject to this DCI and List of Products
Subject to this generic DCI (Attachment D), (5) the EPA Acceptance Criteria (Attachment E),
and (6) the Cost Share and Data Compensation Forms in replying to this butylate Generic Data
Call-In (Attachment F). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for butylate are
contained in the Requirements Status and Registrant's Response, Attachment C. The Agency
has concluded that additional data on butylate are needed on certain technical/manufacturing use
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 butylate products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of butylate, please contact Ms.
Judy Loranger at (703) 308-8056.
If you have any questions regarding the product specific data requirements and
procedures established by this Notice, please contact Mr. Franklin Gee at (703) 308-8008.
All responses to this Notice for the Product Specific data requirements should be
submitted to:
Ms. Veronica Dutch
Special Review and Reregistration Division
Office of Pesticide Programs, H7508W
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Butylate
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ATTACHMENT B
Generic Data Call-In Response Form Instructions
(Form A included in registrants copy only)
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SPECIFIC INSTRUCTIONS FOR
THE DATA CALI^IN RESPONSE FORM
This form is designed to be used to respond to call-ins for generic and product specific
data for the purpose of reregistering pesticides under the Federal Insecticide Fungicide and
Rodenticide Act. Fill out this form each time you are responding to a data call-in for which
EPA has sent you the form entitled "Requirements Status and Registrant's Response."
Items 1 -4 will 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.
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 suggesting for reducing this burden, to Chief, Information Policy
Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, B.C.
20460; and to the Office of Management and Budget, Paperwork Reduction Project 2070-0107,
Washington, D.C. 20503.
INSTRUCTIONS
Item 1. This item identifies your company name, number and address.
Item 2. This item identifies the case number, case name, EPA chemical
number and chemical name.
Item 3. This item identifies the date and type of data call-in.
Item 4. 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. 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. You do not need to complete any
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item on the Requirements Status and Registrant's Response Form
for any product that is voluntarily cancelled.
Item 6a. Check this item if this data call-in is for generic data, as indicated in Item 3 and
if you are eligible for a Generic Data Exemption for the chemical listed in Item
2 and used in the subject product. By electing this exemption, you agree to the
terms and conditions of a Generic Data Exemption as explained in the Data Call-
in Notice.
If you are eligible for or claim a Generic Data Exemption, enter
the EPA registration Number of each registered source of that
active ingredient that you use in your product.
Typically, if you purchase an EPA-registered product from one or
more other producers (who, with respect to the incorporated
product, are in compliance with this and any other outstanding
Data Call-in Notice), and incorporate that product into all your
products, you may complete this item for all products listed on this
form. If, however, you produce the active ingredient yourself, or
use any unregistered product (regardless of the fact that some of
your sources are registered), you may not claim a Generic Data
Exemption and you may not select this item.
Item 6b. Check this Item if the data call-in is a generic data call-in 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.
Item 7a. Check this item if this call-in is a data call-in as indicated in Item 3 for a
manufacturing use product (MUP), and if your product is a manufacturing use
product for which you agree to supply product-specific data. Attach the
Requirements Status and Registrants' Response Form that indicates how you will
satisfy those requirements.
Item 7b. Check this item if this call-in is a data call-in for an end use product (EUP) as
indicated in Item 3 and if your product is a end use product for which you agree
to supply product-specific data. Attach the Requirements Status and Registrant's
Response Form that indicates how you will satisfy those requirements.
Item 8. 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.
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Item 9. Enter the date of signature.
Item 10. Enter the name of the person EPA should contact with questions regarding your
response.
Item 11. Enter the phone number of your company contact.
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ATTACHMENT C
Requirements Status and Registrants' Forms (Form B)
plus Instructions
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SPECIFIC INSTRUCTIONS FOR COMPLETING
THE REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE FORM
Generic Data
This form is designed to be used for registrants to respond to call-ins for generic and
product-specific data as part of EPA's reregistration program under the Federal Insecticide
Fungicide and Rodenticide Act. 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. These instructions are for completion of generic data
requirements.
EPA has developed this form individually for each data call-in addressed to each
registrant, and has preprinted this form with a number of items. DO NOT use this form for any
other active ingredient.
Items 1 through 8 (inclusive) will have been preprinted on the form. You must complete
all other items on this form by typing or printing legibly.
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 suggesting for reducing this burden, to Chief, Information Policy
Branch, PM-223, 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, B.C. 20503.
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INSTRUCTIONS
Item 1. This item identifies your company name, number, and address.
Item 2. This item identifies the case number, case name, EPA chemical number and
chemical name.
Item 3. This item identifies the date and type of data call-in.
Item 4. This item identifies the guideline reference numbers of studies required to support
the product(s) being reregistered. These guidelines, in addition to requirements
specified in the Data Call-In Notice, govern the conduct of the required studies.
Item 5. 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.
Item 6. This item identifies the code associated with the use pattern of the
pesticide. A brief description of each code follows:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food crop
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
87
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Item 7. This item identifies the code assigned to the substance that must be used for
testing. A brief description of each code follows:
EP
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 Ingredient or Pure 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
Item 8. This item identifies the time frame allowed for submission of the study or
protocol identified in item 2. The time frame runs from the date of your receipt
of the Data Call-in Notice.
Item 9, 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.
-------
1. (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.
2. (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.
3, (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 submitting a copy
of the form "Certification of Offer to Cost Share in the Development of
Data" that describes this offer/agreement. By indicating that I have
chosen this option, I certify that I will comply with all the requirements
pertaining to making an offer to share in the cost of developing data as
outlined in the Data Call-in Notice.
4. (Submitting Existing Data) I am submitting an existing study that has
never before been submitted to EPA. By indicating that I have chosen
this option, I certify that this study meets all the requirements pertaining
to the conditions for submittal of existing data outlined in the Data Call-In
Notice and I have attached the needed supporting information along with
this response.
5. (Upgrading a Study) I am submitting or citing 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.
6. (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. I am providing the Agency's
classification of the study.
7. (Deleting Uses) I am attaching an application for amendment to my
registration deleting the uses for which the data are required.
89
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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.
9. (Request for Waiver of Data) I have read the statements concerning data
waivers other than low-volume minor-use data waivers in the Data Call-in
Notice and I request a waiver of the data requirement. I am attaching an
identification of the basis for this waiver and a detailed justification to
support this waiver request. The justification includes, 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.
Item 10. 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. Enter the date of signature.
Item 12. Enter the name of the person EPA should contact with questions regarding your
response.
Item 13. Enter the phone number of your company contact.
90
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DRAFT
COPY
Page 1 of 1
United States Environmental Protection Agency
Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
Form Approved
OMB No. 2070-0107
2070-0057
Approval Expires 03-31-96
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary
1. Company name and Address
4, Guideline
Requirement
Number
62-1 *
82^5 (b) *'••
123-l(a) *
123-1 (b) * ;
123-2 *
163-1 *::.;
164-1 *
:171ri4 (-'©).-: ^-:.:
201-1 *
202*1 ; *, = '-
81-8-SS : *
5. Study Title
Preliminary Analysis
7Prda:y: negro to* -mamma I
Seed germ/seedling emerg
Veget;gtwe: vigor
Aquatic plant growth
i««tii/*dsQrpA}e$drpt f on
Terrestrial field dissipation
stotiig^ stability; : ! " --= ' : -i-
Oroplet size spectrum
ijHifJi :*i*»l,d evaluation ; ;;
Acute .(Jeurotoxi ci ty
J
i
[
Z. Case ft and Name 3. Date and Type of DC I
0071 Butylate GENERIC
Chemical # and Name 041405
Butylate
Progress
Reports
1
y
Y
.] '
2
3
6. Use
Pattern
all
AB = ' . • :
AB
AB :
AB
AB' "•'•.• ; '
AB
AB'.1'.'. •,-"':••
AB
AB':-.,-'- -.'.-'-:-.-:
AB
7. Test
substance
TGAl
TCAl
TGAl
TGAl
TGAl
* See gdln eomnent
TEP
TEP :
TEP
TEP
TGAl
10. Certification
I rertify that the statements made on this form and all attachment- are true, accurate, and complete.
I a^iOHledge that any knowingly false or misleading statement may be punishable by fine, Imprisonment
or both i'-der applicable leu.
Signature and Title of Conpanv's Aim .--^"d Representative
12. Npme of Company Contact
8. Tim
Frame
6 mos.
24 mos.
12 mos.
12 mos .
12 mos.
12 mos.
24 mos.
3 inos.
1 2 TOOS i
12 .mps;;:::;;
12 mos.
3. mos.:
9. Registrant
Response
.-.;.. -: . - .
11. Date
13. Phone Number
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Page 1 of 2
United States Environmental Protection Agency
Washington, D.C. 20460
* COMMENTS FOR GUIDELINE REQUIREMENTS
Case # and Name
0071 Butylate
Chemical # and Name
041405 Butylate
GUIDELINE
COMMENT
62-1
Analysis is needed for one confidential ingredient after consultation with the Agency,
82-5(b) This neurotoxicity study is now required because butylate is chemically related to
several thiocarbamate pesticides that have shown neurotoxicity in long-term repeated
dose studies in rats and/or dogs.
123-1 (a) Phytotoxicity testing is required because this pesticide may pose a hazard to endangered
or threatened species. Runoff, spray drift and volatility from center pivot sprinkler
application can tie expected to reach plants in adjacent fields. The following Tier II
nontarget plants studies are required as confirmatory data: 123-la, 123-lb and 123-2.
123-1 (ta) Refer to the footnote for 123-la.
123-2 Refer to the footnote for 123-la.
163-1 Aged leaching data are required as confirmatory data to assess the mobility of butylate
degradation products. Because of the nature and rate of butylate degradation,
radiolabeled synthesized degradates may be necessary.
164-1 Two field dissipation studies must be conducted in major corn-producing regions where
butylate is commonly used and must reflect typical corn cultivation practices. These
studies must contain volatilization measurements because volatility appears to play a
significant irole in the environmental fate of butylate. One field dissipation study must
be conducted with the EC or FC and the second study must be conducted with either the
granular or microencapsulated formulation.
171-4(e) Based on available storage stability studies that report a 50% decline in residues, the
Agency has concluded that additional storage stability data are required to confirm that
the residues do not exceed the 0.1 ppra tolerance.
-------
Page 2 of 2
United States Environmental Protection Agency
Washington, D.c. 20460
* COMMENTS FOR GUIDELINE REQUIREMENTS
Case ft and Name
0071 Butylate
Chemical # and Name
041405 Butylate
GUIDELINE COMMENT
201-1 This study is required to support the chemigation application method for butylate.
202-1 This study is required to support the chemigation application method for butylate.
81-8-SS This neurotoxicity study is now required because tautylate is chemically related to
several thiocarbamate pesticides that have shown neurotoxicity in long-term repeated
studies in rats and/or dogs.
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ATTACHMENT D
List of all Registrant(s) sent this DCI
(Included in registrants copy only)
91
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ATTACHMENT E
EPA Acceptance Criteria
92
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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
93
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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 toxicologically 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
94
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8. (continued)
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 toxicologically significant impurities
(see #3)
95
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61 Product Identity and Composition
GUIDANCE FOR SUMMARIZING STUDIES
The following criteria apply to the technical grade of the active
ingredient being reregistered. Items 1, 2, 3, and 5 can be
satisfied for most registered products by submission of the
Certified Statement of Formula Ingredients Page (EPA Form 8570-4).
Items 7 and 8 can be satisfied for most technical grade active
ingredients (TGAIs) by submission of a flow chart with chemical
equations for each intended chemical reaction. The flow chart
should include complete chemical structures and names for each
reactant and product of all the reactions.
1. Hame of technical material (include product name and trade name,
if appropriate).
2. Description of each active and intentionally-added inert
ingredient, including name, concentration, and certified limits.
3. Name and upper limit for all impurities present at >_ 0.1% and
those toxicologically significant impurities present at <0.1%.
4. The purpose of each active and intentionally-added inert
ingredient.
5. Chemical name and Registry Number for each active and
intentionally-added inert ingredient (if available).
6. Molecular, structural, and empirical formulas, molecular weight,
and any experimental or internal code number for each active
ingredient.
7. Description of each beginning material in the manufacturing
process.
8. Description of manufacturing process.
9. Discussion of formation of impurities based on established
chemical theory.
96
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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 > 0.1%
2. Degree of accountability or closure >. ca 98%
3. Analyses conducted for certain trace toxic impurities at
lower than 0.1% (examples, nitrosamines in the case of
products containing dinitroanilines or containing secondary
or tertiary 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
> 0.1% and for certain toxicologically significant
impurities at <0.1% along with explanation of how limit
determined
9. Analytical methods to verify certified limits of each
active ingredient and impurities (latter not required if
exempt from requirement of tolerance or if generally
recognized as safe by FDA) are fully described
10. Analytical methods (as discussed in #9) to verify certified
limits validated as to their precision and accuracy
97
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62 Analysis and Certification of Product Ingredients
GUIDANCE FOR SUMMARIZING STUDIES
The following criteria apply to the technical grade of the active
ingredient being reregistered.
1. Number of representative samples analyzed for all active
ingredients and all impurities at >_ 0.1%.
2. Degree of accountability or closure in analyses in item #1.
3. Chemical names of toxic impurities which were analyzed for
levels <0.1%.
4. Brief description(s) of analytical method(s) used to measure
active ingredients and impurities in items #1 and #3.
5. Statement of precision and accuracy of method(s) in item #4.
6. Chemical name and quantities observed (range, mean, standard
deviation) for each ingredient {actives and impurities)
analyzed in item #1.
7. Proposed upper and lower certified limits for each active
ingredient and intentionally added inert with brief explanation
of how limits were determined.
8. Proposed upper certified limit for each impurity present at
>=0.1% and certain toxicologically significant impurities at
<0.1% with brief explanation of how limits were determined.
9. Brief description of analytical method(s) used to verify
certified limits (if same methods as item #4, may reference
latter).
10. Statement of precision and accuracy of method (s) in item #9
(may reference item #5 if applicable).
98
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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 terras
such as "garlic-like, characteristic of aromatic
compounds"
Observed at room temperature
I O
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.]
99
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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/lOO 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 77350}
Data supporting reported value provided
63-12 pH
Measured at about 20 - 25° C
Measured following dilution or dispersion in distilled
water
63-13 Stability
Sensitivity to metal ions and metal determined
^^ Stability at normal and elevated temperatures
Sensitivity to sunlight determined
100
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63 Physical and Chemical Characteristics
GUIDANCE FOR SUMMARIZING STUDIES
The following criteria apply to the technical grade of the active
ingredient being reregistered.
1. Description of color.
2. Description of physical state.
3. Description of odor.
4. Indication of melting point (in C°),
5, Indication of boiling point (in C°).
6. Indication of density, bulk density, and specific gravity.
7. Indication of solubility.
8. Indication of vapor pressure.
9. Indication of dissociation constant.
10. Indication of octanol/water partition coefficient.
11. Indication of PH.
12. Description of stability.
101
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SUBDIVISION F
Guideline Study Title
81-1 Acute Oral Toxicity in the Rat
81-2 Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
81-3 Acute Inhalation Toxicity in the Rat
81-4 Primary Eye Irritation in the Rabbit
81-5 Primary Dermal Irritation Study
81-6 Dermal Sensitization in the Guinea Pig
81-7 Acute Neurotoxicity in the Hen
102
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81-1 Acute Oral Toxicity in the Eat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc)
2. At least 5 young adult rats/sex/group
3. Dosing, single oral may be administered over 24 hrs.
4.*. Vehicle control if other than water.
5. Doses tested, sufficient to determine a toxicity category
or a limit dose (5000 mg/kg).
6. individual observations at least once a day.
7. observation period to last at least 14 days, or until all
test animals appear normal whichever is longer.
8. Individual daily observations.
9._ Individual body weights.
10. Gross necropsy on all animals.
Criteria marked with a * are supplemental and may not be required
for every study.
103
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81-1 Acute Oral Toxicity in the Rat
GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested, e.g. solid, liquid, percent
Al in technical, end-use product, etc.
2. The number of animals/dose/sex tested.
3. Dosing route and regimen.
4. Vehicle used
5. Doses tested and results
6. Individual observations on day of dosing and for at
least 14 days.
7. Summarization of body weights
8. Summarization of gross necropsy
9, Significance of changes from the Acceptance Criteria
104
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81-2 Acute Dermal toxicity in the Rat, Rabbit or Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc)
2. At least 5 animals/sex/group
3.£ Rats 200-300 gm, rabbits 2.0-3.0 kg or guinea pigs 350-
450 gm.
4. Dosing, single dermal.
5. Dosing duration at least 24 hours.
6,*^ Vehicle control, only if toxicity of vehicle is unknown.
7. Doses tested, sufficient to determine a toxicity category
or a limit dose (2000 mg/kg).
8. Application site clipped or shaved at least 24 hours
before dosing
9. Application site at least 10% of body surface area.
10. Application site covered with a porous nonirritating cover
to retain test material and to prevent ingestion.
11. Individual observations at least once a day.
12. ~ Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
Criteria marked with a * are supplemental and may not be reguired
for every study.
105
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81-2 Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested, e.g., solid, liquid, percent AI
in technical, end-use product, etc.
2. The number of animals/sex/dose
3. Weight range of animals
4. Verification of single, dermal exposure
5. Duration of dermal exposure
6. Statement of vehicle control
7. Doses tested and results
8. Preparation of application site
9. Area of application site (percent body surface)
10. Occlusion of test material on application site
11. Individual observations on day of dosing and for at
least 14 days or until all animals appear normal (whichever is
longer).
12. Summarization of body weights
13. Summarization of gross necropsy
14. Significance of changes from Acceptance Criteria
106
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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 urn 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.
107
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81-3 Acute Inhalation Toxicity in the Rat
GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested, e.g., solid, liquid, percent AI
in technical, end-use product, etc.
2. Statement of the inhalability of test substance
3. The number of animals/sex/dose
4. Duration of inhalation exposure
5. Number of chamber air changes/hour and the percent oxygen
content of chamber air
6. Ranges for chamber air temperature and relative humidity
7. Air flow rate
8. Analytical concentrations of test material in breathing zone
9. Results of aerosol particle-size determination
10. Doses tested {or limit dose of 5mg/L or highest attainable)
11. Individual observations on day of dosing and for at least 14
days.
12. Summarization of body weights
13. Summarization of gross necropsy
14. Significance of changes from Acceptance Criteria
108
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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.
g.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 a * are supplemental and may not be required
for every study.
109
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81-4 Primary Eye Irritation in the Rabbit
GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested, e.g., solid, liquid, percent AI
in technical, end-use product, etc.
2. State if material is corrosive, cause severe dermal irritation
or has a pH of <2 or >11.5
3. Number of adult rabbits tested
4. State method of dosing, i.e., instillation into the
conjunctival
sac of one eye per animal
5. Dose administered
6. Note whether solid or granular test material has been ground to
a fine dust
7. State whether eyes were washed and at what time post
instillation (not less than 24 hours)
8. State whether eyes were examined and graded for irritation
before dosing and at what periods after dosing
9. Individual daily observations afterwards, until eyes are normal
or for 21 days
10. Significance of changes from Acceptance Criteria
110
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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 cm.
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 a * are supplemental and may not be required
for every study.
Ill
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81-5 Primary Dermal Irritation study
GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested, e.g., solid, liquid, percent AI
in technical, end-use product, etc.
2. State if material is corrosive, has a pH <2 or >11.5, or has a
dermal LD 50 <200 mg/kg
3. Number of adult animals tested
4. Amount applied
5. Duration of dermal exposure
6. Preparation of application site (shaved or clipped at specified
time before dosing)
7. Area of application site
8. Method for occlusion of application site
9. Note removal of test material and if skin was washed with water
10. State times post application when site was graded for
irritation
11. Individual observations for day of dosing and individual daily
observations thereafter
12. Significance of changes from Acceptance Criteria.
112
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81-6 Dermal Sensitization in the Guinea Pig
ACCEPTANCE CRITERIA
dose 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. One of the following methods is utilized;
Freund's complete adjuvant test
Guinea pig maximization test
Split adjuvant technique
~"_^_ Buehler test
Open epicutaneous test
Mauer optimization test
Footpad technique in guinea pig
4. Complete description of test
5.^. Reference for test.
6. Test followed essentially as described in reference
document.
7. Positive control included (may provide historical data
conducted within the last 6 months)
Criteria marked with a * are supplemental and may not be required
for every study.
113
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81-6 Dermal Sensitization in the Guinea Pig
GUIDANCE FOR SUMMARIZING STUDIES
l. The form of pesticide tested, e.g., solid, liquid, percent AI
in technical, end-use product, etc.
2. State if material is corrosive or has pH <2 or >11.5.
3. State specific method utilized
4. Complete description of specific method
5. Reference for the specific method employed
6. Note adherence of the protocol to that in the reference for
the specific method utilized
7. State the positive control tested
8. Significance of changes from Acceptance Criteria
114
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81-7 Acute Neurotoxicity in the Hen
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Study performed on an organophosphate cholinesterase
inhibiting compound.
2. Technical form of the active ingredient tested.
3.j^ Positive control utilized.
4. Species utilized, domestic laying hen 8-14 months of age.
5.Dosing oral by gavage or capsule (dermal or inhalation
may be used).
6. An acute oral LD is determined.
7. Dose tested equal to an acute oral LD or a limit test of
5000 mg/kg.
8.j* Dosed animals may be protected with atropine and/or 2-
~PAM.
9, Sufficient test animals so that at least 6 survive.
10. Negative (vehicle) control group of at least 6 hens
11.* Positive control of at least 4 hens, {if used)
12. Test dose repeated if no signs of delayed neurotoxicity
observed by 21 days after dosing.
13. Observation period 21 days after each dose.
14. Individual daily observations.
15. Individual body weights.
16. Individual necropsy not required.
17. Histopathology performed on all animals. Tissue to be
fixed in sin preferably using whole animal perfusion
techniques. At least three sections of each of the
following tissues:
brain, including medulla oblongata
"spinal cord; upper cervical, mid-thoracic and
lumbro-sacral regions
tibial nerve; proximal regions and branches
"sciatic nerve
criteria marked with a * are supplemental and may not be required
for every study.
115
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ATTACHMENT F
Cost Share and Data Compensation Forms
116
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&EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF OATA
out ftta.
1070-010?
2070-0417
Public reporting burden lor this coHeetion of information is estimated to average 15 minutes per i*spon«e. Inetuolng
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments ngarolng the burden estimate or any other
aspect of this collection of Information, including suggestions for reducing this burden, to Chief, Information PoBcy
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 80503.
PIMM fill in blanks below.
C*BM*r NM»
tiiMilaal Hwn«
I Certify that:
My wmpany Is willing to develp and submit the data required by EPA under the authority of the Federal
Insecticide, FungWd* and Rodentfade Act (FIFRA). If necessary. However, my company would prtfer to
enter Into an agreement with one or more registrants to develop jointly or share In the cost of developing
My firm has offered In witting to enter Into such an agreement. That offer was Irrevocable and Included a
offer to be bound by •Attrition decision under section 3(c)<2)(B)(in> of FIFRA If flnaJ agreement on al
terms could not be readied otherwise. This offer was made to tht tetowtng flrm(s) on the following
date(s):
•inn*.)
0*4t *l Otltr
Certification:
icertVythatlamduiyatfhoilzedloraDitseflltriecwTp^ navtmadeoi
tWstorm and al attacrmontt thereto are true, accurate, and complete. I acknowledge that any knowingly false or
maJeecfriQ statement may be purtshable by fine or inprisoremrtw both iiiK^appisabie law.
Sl9Mtun ef Ceevuty'e Aa^ieriaetf
Dele
HM *a4 YUto (1
TTM«T MM)
•PA
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&EPA
United Statta Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
Ha. 2070-0107
1070-0097
*-3i-
Public reporting bunjen for this collection at information is estimated to average 15 minutes per response. Muding
lime tor reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection ot information. Send comments regarding tht burden estimate or any other
aspect ef this collection ol information, heading suggestions (or 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 Offct
or Management and Budget, Paperwork Reduction Project (2070-0106), Washington, OC 20503.
Please nil In blanks below.
COMM'-? MOM
Clwmtul MMM
Cempany Number
f PA CtwMlMl Nwmb+f
I Certify that
1 . For each study cited in support o( registration or reregistration under the Federal Insecticide. Fungicide and
Rodentidde Act (FIFRA) that is an exckaive use study, I am the original data submitter, or I have obtained the
written penr.gsion ol the original data submitter to dte that study.
2.
Thai tor eaen study cied in support of registraiion or reregatraicn under FIFRA thai is NOT an exdu*wtu««
study. I am the original data submtter. or I have obtained the written permission of the original data submitter, or I
have notified in writing tht cornpanypes) that submitted data I have cited and have ottered te: (a) Pay
compensation tor those data in accordance with sections 3(3(1 )(0) t"d 3(cH2)(D) Ot FIFRA; and (b) Commence
negotiation to determine which data are subject to the compensation requirement of FIFRA and tht amount of
compensation due, i any. The companies I have notified are: (check one)
I]
AS companies en the data submitters' fist for the active ingredient isted on this term (Cke-Afl
Method or Cite-M Option under the Selective Method). (Also sign the General Offer 10 Pay
J
w»w*w./
M The companies who have submitted the stueK
sheet*, or indicated on the Vtaehed "Require*
registraUonor reregisnten under FIFRA.
» fisted Oft the back of this term of attached
nents Status and Registrants' Response Form.'
[0) of FIFRA tor the studies t have cfttd in support ol
•Ifiutyr*
MM* «* llde (Meet* type « Mat)
GENERAL OFFER TO PAY: I hereby offer end agree 1
MnrrtrBtinn nr t*rmnirit-*tlnn fj irmj rvrv+H-tf In th* A-rl«
ivyiMiauoiior leregisirauon o» my proqucn, 10 B*e e«e
t^«u,™
HUM m4 Till* (MMM Tfp» «r Mnt)
o pay compensation to ether pi
rt required by FIFRA sections:
Oat*
irtons. wth regard to the
Kc}(1)(D)and3
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APPENDIX G
Product Specific Data Call-In
117
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
DATA CALL-IN NOTICE
CERTIFIED MAIL OFFICE OF
v J
SU* i PREVENTION. PESTICIDES AND
TOXIC SUBSTANCES
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide
products containing the active ingredient identified in
Attachment A of this Notice, the Data Call-In Chemical Status
Sheet. to submit certain product specific 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 A through G; or
2. Why you believe you are exempt from the requirements
listed in this Notice and in Attachment c,
Requirements Status and Registrant's Response Form,
(see section III-B); or
3. Why you believe EPA should not require your submission
of product specific 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 B, Data Call-in Response Form, as well as a
list of all registrants who were sent this Notice (Attachment F) .
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 toy
OMB Approval No. 2070-0107 (expiration date 3-31-96).
Recycled/Recyclable
Printed with Say/Canola ink on paper that
contains at laast 50% recycled fiber
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This Notice is divided into the following 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:
A - Data Call-in Chemical Status Sheet
B - Data Call-In Response Form
C - Requirements Status and Registrant's Response Form
D - EPA Grouping of End-Use Products for Meeting Acute
Toxicology Data Requirements for Rereaistration
E - List of Registrantsfsi sent this PCI
F - EPA Acceptance Criteria
G - Cost Share and Data Compensation Forms
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active
ingredient and reevaluated the data needed to support continued
registration of the subject active ingredient. The Agency has
concluded that the only additional data necessary are product
specific data. No additional generic data requirements are being
imposed. You have been sent this Notice because you have
product(s) containing the subject active ingredient.
SECTION IT. DATA REQUIRED BY THIS NOTICE
II-A. DATA REQUIRED
The product specific data required by this Notice are
specified in Attachment C, Requirements Status and Registrant's
Response Form. Depending on the results of the studies required in
this Notice, additional 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 Attachment C, Requirements Status
and Registrants Response F_orm, within the timeframes provided.
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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 (NTTS), Attn: Order Desk, 5285 Port Royal Road,
Springfield, Va 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if the OECD-
recommended test standards conform to those specified in the
Pesticide Data Requirements regulation (40 CFR § 158.70). When
using the OECD protocols, they should be modified as appropriate so
that the data generated by the study will satisfy the requirements
of 40 CFR § 158. Normally, the Agency will not extend deadlines
for complying with data requirements when the studies were not
conducted in accordance with acceptable standards. The OECD
protocols are available from OECD, 1750 Pennsylvania Avenue N.W.,
Washington, D.C. 20006.
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 160.3(a)(6)].
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3fdf21fBl NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-In does not in
any way supersede or change the requirements of any previous Data
Call-Infs>, 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
III-A. SCHEDULE FOR RESPONDIHG TO THE AGENCY
The appropriate responses initially required by this Notice
for 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.
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III-B. OPTIONS FOR RESPONDING TO THE AGENCY
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. A
discussion of options relating to requests for data waivers is
contained in Section III-D.
There are two forms that accompany this Notice of which,
depending upon your response, one or both must be used in your
response to the Agency. These forms are the Data-Call-in Response
Form, and the Requirements Status and Registrant's Response Form.
Attachment B and Attachment C. The Data Call-In 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 must be submitted for each product listed on the
Data Call-in Response Form unless the voluntary cancellation option
is selected or unless the product is identical to another (refer to
the instructions for completing the Data Call-in Response Form in
Attachment B}. 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 A.
1. Voluntary Cancellation - You may avoid the requirements of
this Notice by requesting voluntary cancellation of your product(s)
containing the active ingredient that is the subject of this
Notice. If you wish to voluntarily cancel your product, you must
submit a completed Data Call-In Response Form, indicating your
election of this option. Voluntary cancellation is item number 5
on the Data Call-In Response Form. If you choose this option, this
is the only form 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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2. Satisfying the Product Specific Data Requirements of this
Notice. There are various options available to satisfy the product
specific data requirements of this Notice. These options are
discussed in Section III-C of this Notice and comprise options 1
through 6 on the Requirements Status and Registrant's Response Form
and item numbers 7 a and 7b on the Data Call-in Response Form.
Deletion of a use(s) and the low volume/minor use option are not
valid options for fulfilling product specific data requirements.
3. Request for Product Specific Data Waivers. Waivers for
product specific data are discussed in Section III-D of this Notice
and are covered by option 7 on the Requirements Status and
Registrant's Response Form. If you choose this option, you must
submit both forms as well as any other information/data pertaining
to the option chosen to address the data requirement.
III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-In Response Form that you
agree to satisfy the product specific data requirements (i.e. you
select option 7a or 7b) , then you must select one of the six
options on the Requirements Status and Registrant7s 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
timeframe (Developing Data)
(2) I have entered into an agreement with one or more
registrants to develop data jointly (Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been
submitted previously to the Agency by anyone (Submitting
an Existing Study)
(5) I am submitting or citing data to upgrade a study
classified by EPA as partially acceptable and upgradeable
(Upgrading a Study)
(6) I am citing an existing study that EPA has classified as
acceptable or an existing study that has been submitted
taut not reviewed by the Agency (Citing an Existing Study)
Option l. 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.
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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. 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. Agree to Share in Cost to Develop Data —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. If you choose to enter into an
agreement to share in the cost of producing the required data but
will not be submitting the data yourself, you must provide the name
of the registrant who will be submitting the data. You must also
provide EPA with documentary evidence that an agreement has been
formed. Such evidence may be your letter offering to join in an
agreement and the other registrant's acceptance of your offer, or a
written statement by the parties that an agreement exists. The
agreement to produce the data need not specify all of the terms of
the final arrangement between the parties or the mechanism to
resolve the terms. Section 3(c)(2)(B) provides that if the parties
cannot resolve the terms of the agreement they may resolve their
differences through binding arbitration.
Option 3. Offer to Share in the Cost of Data Development —
This option only applies to acute toxicity and certain efficacy
data as described in option 2 above. 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
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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(s) developing the data
has refused to accept your 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 3570-32,
Certification of Offer to Cost Share in the Development of Data,
Attachment G. In addition, you must demonstrate that the other
registrant to whom the offer was made has not accepted your offer
to enter into a costsharing 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 or failing agreement to be bound by
binding arbitration as provided by FIFRA section 3(c)(2)(B)(iii)
and must not qualify this offer. The other registrant must also
inform EPA of its election of an option to develop and submit the
data required by this Notice by submitting a Data Call-in Response
Form and a Requirements Status and Registrants Response Form
committing to develop and submit the data reguired by this Notice.
in order for you to avoid suspension under this option, you may
not withdraw your offer to share in the burdens 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 will normally be subject to
initiation of suspension proceedings, unless you commit to submit,
and do submit the required data in the specified time frame. In
such cases, the Agency generally will not grant a time extension
for submitting the data.
Option 4, Submitting an Existing Study: — If you choose to
submit an existing study in response to this Notice, you must
determine that the study satisfies the requirements imposed by this
Notice. You may only submit a study that has not been previously
submitted to the Agency or previously cited by anyone. Existing
studies are studies which predate issuance of this Notice. Do not
use this option if you are submitting data to upgrade a study. (See
Option 5).
You should be aware that if the Agency determines that the
study is not acceptable, the Agency will require you to comply with
this Notice, normally without an extension of the required date of
submission. The Agency may determine at any time that a study is
not valid and needs to be repeated.
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To meet the requirements of the DCI Notice for submitting an
existing study, all of the following three criteria must be clearly
met:
a. You must certify at the time that the existing study is
submitted that the raw data and specimens from the study are
available for audit and review and you must identify where they
are available. This must be done in accordance with
the requirements of the Good Laboratory Practice (GLP)
regulation, 40 CFR Part 160. As stated in 40 CFR 160.3(j)
11 '[r]aw data' means any laboratory worksheets, records,
memoranda, notes, or exact copies thereof, that are the result
of original observations and activities of a study and are
necessary for the reconstruction and evaluation of the report
of that study. In the event that exact transcripts of raw data
have been prepared (e.g., tapes which have been transcribed
verbatim, dated, and verified accurate by signature), the exact
copy or exact transcript may be substituted for the original
source as raw data. 'Raw data' may include photographs,
microfilm or microfiche copies, computer printouts, magnetic
media, including dictated observations, and recorded data from
automated instruments." The term "specimens", according to 40
CFR 160.3(k) , means "any material derived from a test system
for examination or analysis."
b. Health and safety studies completed after May 1984 must also
contain all GLP-required quality assurance and quality control
information, pursuant to the requirements of 40 CFR Part 160.
Registrants must also 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 are usually not available for such studies.
8
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If you submit an existing study, you must certify that the
study meets all requirements of the criteria outlined above.
If you know of a study pertaining to any requirement in this
Notice which does not meet the criteria outlined above but does
contain factual information regarding unreasonable adverse effects,
you must notify the Agency of such a study. If such study is in
the Agency's files, you need only cite it along with the
notification. If not in the Agency's files, you must submit a
summary and copies as required by PR Notice 86-5.
Option 5. Upgrading a Study — If a study has been classified
as partially acceptable and upgradeable, you may submit data to
upgrade that study. The Agency will review the data submitted and
determine if the requirement is satisfied. If the Agency decides
the requirement is not satisfied, you may still be required to
submit new data normally without any time extension. Deficient,
but upgradeable studies will normally be classified as
supplemental. However, it is important to note that not all
studies classified as supplemental are upgradeable. If you have
questions regarding the classification of a study or whether a
study may be upgraded, call or write the contact person listed in
Attachment A. 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 should also be used to cite data that has been
previously submitted to upgrade a study, but has not yet been
reviewed by the Agency. You must provide the MRID number of the
data submission as well as the MRID number of the study being
upgraded.
The criteria for submitting an existing study, as specified in
Option 4 above, apply to all data submissions intended to upgrade
studies. Additionally your submission of data intended to upgrade
studies must be accompanied by a certification that you comply with
each of those criteria as well as a certification regarding
protocol compliance with Agency requirements.
Option 6, Citing Existincf 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-
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guideline" or "core minimum." 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.
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, as appropriate.
III-D REQUESTS FOR DATA WAIVERS
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 Requirements Status and
Registrant's Response Form. Product specific data requirements for
product chemistry, acute toxicity and efficacy {where appropriate)
are required for all products and the Agency will 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.
IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products
subject to this Notice due to failure by a registrant to comply
with the requirements of this Data Call-in Notice, pursuant to
FIFRA section 3(c)(2)(B). Events which may be the basis for
issuance of a Notice of Intent to Suspend include, but are not
limited to, the following:
1. Failure to respond as required by this Notice within 90
days of your receipt of this Notice.
10
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2. Failure to submit on the required schedule an acceptable
proposed or final protocol if 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 if 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 either to:
a. Inform EPA of intent to develop and submit the data
required by this Notice on a Data_C_all-In Response Form and a
Requirements Status and Registrant's Response Form;
b. Fulfill the commitment to develop and submit the data as
required by this Notice; or
c. Otherwise take appropriate steps to meet the requirements
stated in this Notice, unless you coinmit to submit and do
submit the required data in the specified time frame.
9. Failure to take any required or appropriate steps, not
mentioned above, at any time following the issuance of this
Notice.
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
The Agency may determine that a study (even if submitted within
the required time) is unacceptable and constitutes a basis for
issuance of a Notice of Intent to Suspend. The grounds for
suspension include, but are not limited to, failure to meet any of
the following:
11
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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 reguirements regarding the submission of protocols (if
applicable), 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 would generally 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 must also 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
12
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distributors, retailers and end users to sell, distribute or use
such existing stocks until the stocks are exhausted. Any sale,
distribution or use of stocks of voluntarily cancelled products
containing an active ingredient for which the Agency has particular
risk concerns will be determined on a case-by-case basis.
Requests for voluntary cancellation received after the 90 day
response period required by this Notice will not result in the
Agency granting any additional time to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was
due unless you demonstrate to the Agency that you are in full
compliance with all Agency requirements, including the requirements
of this Notice. For example, if you decide to voluntarily cancel
your registration six months before a 3 year study is scheduled to
be submitted, all progress reports and other information necessary
to establish that you have been conducting the study in an
acceptable and good faith manner must have been submitted to the
Agency, before EPA will consider granting an existing stocks
provision.
SECTION V. REGISTRANTS7 OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(2) states that
if at any time after a pesticide is registered a registrant has
additional factual information regarding unreasonable adverse
effects on the environment by the pesticide, the registrant shall
submit the information to the Agency. Registrants must notify the
Agency of any factual information they have, from whatever source,
including but not limited to interim or preliminary results of
studies, regarding unreasonable adverse effects on man or the
environment. This requirement continues as long as the products
are registered by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and
procedures established by this Notice, call the contact person(s)
listed in Attachment A, the Data Call-Tn Chemical Status Sheet.
All responses to this Notice (other than voluntary cancellation
requests) must include a completed Data Call-in Response Form and a
completed Retirements Status and Registrant's Response Form
(Attachment B and Attachment C) and any other documents required by
this Notice, and should'be submitted to the contact person(s)
identified in Attachment A. If the voluntary cancellation option is
chosen, only the Data Call-in Response Form need be submitted.
13
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The Office of Compliance Monitoring (OCM) of the Office of
Pesticides and Toxic Substances (OPTS), EPA, will be monitoring the
data being generated in response to this Notice.
Sincerely yours,
-* /
Daniel M. Barolo, Director
Special Review and
Reregistration Division
Attachments
A - Data Call-in Chemical Status Sheet
B - Data Call-in Response Form
C - Requirements status and Registrant's Response Form
D - EPA Grouping of End-Use Products for MeetincLAcute
Toxicology Data Requirements for Rereqistration
E - List of Registrants Sent This PCI
F - EPA Acceptance Criteria (refer to Attachment E, EPA
Acceptance Criteria for Generic PCI)
G — Cost Share and Data Compensation Forms
14
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ATTACHMENT A
Product Specific DCI Chemical Status Sheet
118
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BUTYLATE: DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have
products containing butylate.
This Product Specific Data Call-in Chemical Status Sheet, contains an overview of
data required by this notice, and point of contact for inquiries pertaining to the reregistration
of butylate. 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 B), (3) the
Requirements Status and Registrant's Form (Attachment C), (4) EPA's Grouping of End-Use
Products for Meeting Acute Toxicology Data Requirement (Attachment D), (5) the EPA
Acceptance Criteria (Attachment E), (6) a list of registrants receiving this DCI (Attachment
F) and (7) the Cost Share and Data Compensation Forms in replying to this butylate Product
Specific Data Call-in (Attachment G). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for butylate are
contained in the Requirements Status and Registrant's Response. Attachment C. The Agency
has concluded that additional data on butylate 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 butylate products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of butylate, please contact
Ms. Judy Loranger at (703) 308-8056.
If you have any questions regarding the product specific data requirements and
procedures established by this Notice, please contact Mr. Franklin Gee at (703) 308-8008.
All responses to this Notice for the Product Specific data requirements should be
submitted to:
Ms. Veronica Dutch
Special Review and Reregistration Division
Office of Pesticide Programs, H7508W
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Butylate
119
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ATTACHMFJVT B
Product Specific Data Call-Iu Response Forms (Form A)
plus Instructions
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE" FORM FOR PRODUCT SPECIFIC DATA
Item 1-4. Already completed by EPA.
Item 5. If you wish to voluntarily cancel your product, answer "yes". If you choose
this option, you will not have to provide the data required by the Data Call-in
Notice and you will not have to complete any other forms. Further sale and
distribution of your product after the effective date of cancellation must be in
accordance with the Existing Stocks provision of the Data Call-In Notice
(Section IV-C).
Item 6. Not applicable since this form calls in product specific data only. However, if
your product is identical to another product and you qualify for a data
exemption, you must respond with "yes" to Item 7a (MUP) or 7B (EUP) on
this form, provide the EPA reregistration numbers of your source (s); you
would 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.
Item 7a. For each manufacturing use product (MUP) for which you wish to maintain
registration, you must agree to satisfy the data requirements by responding
"yes."
Item 7b_ For each end use product (EUP) for which you wish to maintain registration,
you must agree to satisfy the data requirements by responding "yes." 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. See item 6 with regard to identical products and data
exemptions.
Items 8-11 .Self-explanatory.
Note: You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that your
product has already been transferred to another or that you have already voluntarily
cancelled this product. For these cases, please supply all relevant details so that EPA
can ensure that its records are correct.
121
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DRAFT COPY
Page 1 of 1
United States Environmental Protection Agency
Washington, D. c. 20460
DATA CALL-IN RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested
Use additional sheet(s) if necessary.
1. Company name and Address 2. Case # and Name
SAMPLE COMPANY 0071 Butylate
KO STREET ADDRESS
NO CITY, XX 00000
4. EPA Product
Registration
HNNNNK-KHNNN
5 . [ wish to
cancel this
product regis-
tration volun-
tarily.
8. Certification
1 certify that the statements made on th
1 acknowledge that any knowingly false c
or both under applicable law.
Signature and Title of Company's Authori
6. Generic Data
6a. I am ctaimimg a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
N.A.
6b. t agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
N.A.
is form and all attachments are true, accurate, and complete.
>r misleading statement may be punishable by fine, imprisonment
zed Representative
7. Product Specific
Form Approved
OMB No. 2070-0107
2070-0057
Approval Expires 03-31-96
on this form.
3. Date and Type of DC I
PRODUCT SPECIFIC
Data
Ts. My product is a MUP and
! agree to satisfy the HUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
10. Name of Company Contact
7b. My product is an EUP and
agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
9. date
11.
Phone Muraber
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ATTACHMENT C
Product Specific Data Call-In Requirements Status and
Registrant's Response Forms (Form B) plus Instructions
122
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE" FORM FOR PRODUCT SPECIFIC DATA
Item 1-3 Completed by EPA. Note the unique identifier number assigned by EPA in
item 3. This number must be used in the transmittal document for any data
submissions in response to this Data Call-In Notice.
Item 4. The guidelines reference numbers of studies required to support the product's
continued registration are identified. These guidelines, in addition to the
requirements specified in the 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. The study title associated with the guideline reference number is identified.
Item 6. The use patters (s) of the pesticide associated with the product specific
requirements is (are) identified. For most product specific data requirements,
all use patterns are covered by the data requirements. In the case of efficacy
data, the required studies only pertain to products which have the use sites
and/ or pests indicated.
Item 7. The substance to be tested is identified by EPA. For product specific data, the
product as formulated for sale and distribution is the test substance, except in
rare cases.
Item 8. The due date for submission of each study is identified. It is normally based
on 8 months after issuance of this Reregistration Eligibility Decision unless
EPA determines that a longer time period is necessary.
Item 9. Enter Only one of the following response codes for each data requirement to
show how you intend to comply with the data requirements listed in this table.
Fuller descriptions of each option are contained in the Data Call-in Notice,
1. I will generate and submit data by the specified due date (Developing Data). 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.
2. I have entered into an agreement with one or more registrants to develop data jointly
(Cost Sharing). I am submitting a copy of this agreement. I understand that this
option is available on for acute toxicity or certain efficacy data and only if EPA
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
123
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agreement is committing to submit or provide the required data; if the required study
is not submitted on time, my product my be subject to suspension.
3. I have made offers to share in the cost to develop data (Offers to Cost Share). I
understand that this option is available only for acute toxicity or certain efficacy data
and only if EPA indicates in an attachment to this Data Call-In Notice that my
product is similar enough to another product to qualify for this option. 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 also submitting a
completed " Certification of offer to Cost Share in the Development Data" form. 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 require
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
(Section in-C.l.) apply as well,
4. By the specified due date, I will submit an existing study that has not been submitted
previously to the Agency by anyone (submitting an Existing Study), I certify that this
study will meet all the requirements for submittal of existing data outlined in option 4
in the Data Call-In Notice (Section m-C.l.) and will meet the attached acceptance
criteria (for acute toxicity and product chemistry data). I will attach the needed
supporting information along with this response. I also certify that I have determined
that this study will fill the data requirement for which I have indicated this choice.
5. By the specified due date, I will submit or cite data to upgrade a study classified by
the Agency as partially acceptable and upgrade (upgrading a study). I will submit
evidence of the Agency's review indicating that the study may be upgraded and what
information is required to do so. I will provide the MRID or Accession number of
the study at the due date. I understand that the conditions for this Option outlined
Option 5 in the Data Call-In Notice (Section IH-C.l.) apply.
6. By the specified due date, I will cite an existing study that the Agency has classified
as acceptable or an existing study that has been submitted but not reviewed by the
Agency (Citing an Existing Study). If 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 EPA 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) number (s) for
the cited data on a "Product Specific Data Report" form or in a similar format. If I
cite another registrant's data, I will submit a completed "Certification With Respect
To Data Compensation Requirements" form.
124
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7. I request a waiver for this study because it is inappropriate for my product (Waiver
Request). 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 require 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 chosen. I also understand that the deadline for
submission of data as specified by the original data cal-in notice will not change.
Items 10-13. Self-explanatory,
NOTE: You may provide additional information that does not fit on this form in a
signed letter that accompanies this form. For example, you may wish to
report that your product has already been transferred to another company or
that you have already voluntarily cancelled this product. For these cases,
please supply all relevant details so that EPA can ensure that its records are
correct.
125
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DRAFT COPY
Page 1 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
Font Approved
OMB So. 2070-0107
2070-0057
Approval Expire! OJ-31-96
IH3TBUCTIOHB] Hea»« type or print in ink. Pl.*.e r«ad carefully th» attached induction, and eupply the information reque.
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LI. Date
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13. Phone Humber
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DRAFT COPY
Page 2 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
liraTRUCTIMISi Flame type or print In ink. Plaaie r«*d carefully the attached instruction* and supply the
Uae additional »heet(») if nacaaaary.
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OMB Ho. 2070-0107
2070-0057
Approval Bxplrea 03-31-96
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DRAFT COPY Page 1 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case f and Name: 0071 Butylate
HP • manufacturing-use product; BP • end-ma product! provided f emulators purchase their active ingredient)s) fron. a ragl»tered source, they need not submit or cite
data pertaining to the purchased prod.uat. [BOTEt If a product la a 100 percent repackage of another registered product th«t 1* purchased, and any use for the product doaa
not differ from thooe of thai purchased and registered source, users are not subject to any data requirements Identified in Urn tablu.]; TEP - typical end-use product)
TOAI - technical grade of the active ingredient) Pnl • "put*" active Ingredient; PAIHA - "pure" active ingredient, radlolabelea.
Da* Categories 1071
A - Terreattial food crept B - Terrestrial food feed crap c - Terrestrial nonfood crop D - Aquatic food crop S - Aquatic nonfood outdoor
F - Aquatic nonfood Industrial O - Aquatic nonfood residential H - Greenhouse food crop 1 - Greenhouse nonfood crop J - Forestry
K - Residential outdoor 1 - Indoor food M - Indoor nonfood M - Indoor Medical O - Indoor residential
\Tt\* following notes ara referenced in column two (5. fltudy Title) of the RBOUIBBMESIS STATUS AMD HEOlSTRMTP'a FESPOH3B fora.]
1 Requirement! pertaining to product identity, composition, analysis, and certification of ingredlenta are detailed further in the following sectional *156.155 for
product identity and composition (61-1); «ise.l60, 158,162, and 138,16S for description of storting materials and manufacturing procass (61-2)j MSB.187 for
discussion of formation of Ispurities («-3)j *1S8.170 for prellalnary analyaia (62-1); '158.175 for certification of Units |62-2)| and "158.180 for enforcement
analytical nattiod* (H-3).
2 A schematic
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United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0071 Butylate
Footnotes (cont.):
^~
which have daoonatratod • potential to adversely affect the visual ay •tarn. Raglatrants. should consult with the agency for development of protocols and methodology
prior to Initiation of etudles..
37 Testing of th» EP dilution It required 1( It can be reasonably anticipated that th« result! of such tMXlng oay nMt the criteria for restriction to u«e by certified
applicators spec Hied In* 40 CFTt 152.170(b) or th« ccitecle for Initiation of epeclal review specified in 40 CPU 154.7
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ATTACHMENT D
EPA's Grouping of End-Use Products for Meeting Acute
Toxicology Data Requirements for Registration
126
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ATTACHMENT D
EPA'S BATCHING OF BUTYLATE END-USE 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
butylate (s-ethyl diisobutylthiocarbamate), 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. Frequently acute toxicity data on individual products has been
found to be incomplete. Notwithstanding the batching process, the Agency reserves the right
to require, at any time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or
cite a single battery of six acute 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 cited, the registrant must clearly identify the material tested by its EPA registration
number.
In deciding how to meet the product specific data requirements, registrants must Mow
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
127
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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.
Table I indicates 1 batch including 2 products containing the active ingredient butylate.
Table I.
Batch No.
1
EPA Reg. No.
34704-702
10132-222
% Butyl ate
25.1
85.1
Formulation
Emulsifiable Concentrate (EC)
EC
Table I! lists 12 products that were either considered not to be similar for purposes of acute
toxicity or the Agency lacked sufficient information for decision making and were not placed in any
batch. Registrants of these products are responsible for meeting the acute toxicity data
requirements for each product.
Table II.
EPA Reg. No.
10181-181
10182-182
10182-192
10182-201
10132-211
10132-236
10182-248
10182-249
10182-269
10182-286
% Butylate, And Other Active
Ingredient
78.06
10.0
88.2
18.0
5.7 Atrazine
77.3
48.2
56,8
1 3.9 Atrazine
74.0
97.O
89.6
Formulation
EC
Granular
EC
Granular
EC
Pellet/tablet
EC
EC
Technical
EC
128
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EPA Reg. No.
10122-288
34704-633
% Butyla'e, And Other Active
Ingredient
85-1
10.0
Formulation
EC
Granular
129
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ATTACHMENT E
EPA Acceptance Criteria
(Refer to Generic DCI Acceptance Criteria Attachment £)
130
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ATTACHMENT F
List of Registrants sent this DCI
(Included in registrants copy only)
131
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ATTACHMENT G
Product Specific Data Call-in Cost Share and
Data Compensation Forms
132
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United Stiiw Environmental Protection Agency
^ ^^> Jt Washington, DC 20460
^Hsf l^aKeU CERTIFICATION OF OFFER TO COST
\J^mm aTl SHARE IN THE DEVELOPMENT OF DATA
fit* Aaam»«
OH* tU. 1070.0107
2070-003?
A»«w*iml fxBtrw 3-u-f«
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 tnis collection ol information, including suggestions for reducing mis 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
ot Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Please fill In blanks below.
Compuy Nam«
Ch*ffife»l Nam*
Company Numbw
EPA ChtmlMl NumUr
I Certify that:
My company is willing to develp and submit the data required by EPA under the authority ot the Federal
Insecticide, Fungicide and Rodenticide Act {F1FRA}, 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
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
offer to b« bound by arbitration decision under section 3(c)(2){B)(iii) of RFRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following flrm{s) on the following
date(s):
0*M •! Offer
I certly that I am duly auttort^ to represent the convanyn^ havemadeon
this form and af attachments therein am ttue, accurate, and complete. lactanwMo^thatanyknowingtyfatseor
statwne^n^btpurtshjble by fine w
Signature ef
Oeie
»m» wttf Tltl* (I
EPA
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United Statts Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
OUt No.
2070-0101
2010-005T
Public reporting burden (or this collection of information is estimated to average IS minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection ol 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 NIIM
CtMffltttl Mm*
Compsny Number
EPA CtMtnical Number
I Certify mat:
i For each study cited in support of registration or ^registration under the Federal insecticide. Fungicide and
Rodentictte Act (FIFRA) mat is an exclusive use study, I am the original data submitter, or I have obtained the
written permission of me original data submitter to die that study.
2 That tor each study died in support of registration or ^registration under F1FRA that is NOT an exclusive use
study | am th« original data sutwtter.w l fttvtcttajnedtte
have notified ft wrting the companyfies) 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 3l(A*wr»
HM« «n« Tine (Ptoee* Type er MM)
GBM6RAL OFFER TO PAY: I htrtby offtr and agree to pay compensation to othtr persons, with regard to me
ragistration or reragistratien of my products, to the extent required by FIFRA sector* 3(c)(i)(0) and 3(c)[2>(D)
NMM end flu* (»••«• Typ« ec Print)
EPA f«t» 4S70-31 (4-tO)
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