REREGISTRATION ELIGIBILITY DECISION
NUOSEPT 145®
LIST C
CASE 3052
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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1
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregistration eligibility review and decisions on the pesticide chemical case Nuosept 145®
which includes the active ingredient [[[(2-dihydro-5-methyl-3(2H)-oxazolyl)-l-
methylethoxy]methoxy]methoxy] methanpl. The enclosed Reregistration Eligibility Decision
(RED) contains the Agency's evaluation of the data base of these chemicals, its conclusions of
the potential human health and environmental risks of the current product uses, and its
decisions and conditions under which these uses and products will be eligible for
reregistration. The RED includes the-data and labeling requirements for products for
reregistration.
To assist you with a proper response, read the enclosed document entitled "Summary
of Instructions for Responding to the RED". This summary also refers to other enclosed
documents which include further instructions. You must follow all instructions and submit
complete and timely responses. The first set of required responses are due 90 days from
the date of this letter. The second set of required responses are due 8 months from the
date of this letter. Complete and timely responses will avoid the Agency taking the.
enforcement action of suspension against your products.
If you have questions on the product specific data requirements or wish to meet with
the Agency, please contact the Special Review and Reregistration Division representative
Franklin Gee at (703) 308-8008. Address any questions on required generic data to the
Special Review and Reregistration Division representative Kathleen Depukat at 703-308-8587.
Sincerely yours,
Louis P. True, Jr., Acting Director
Special Review
and Reregistration Division
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1. DATA CALL-IN (PCD OR "90-DAY RESPONSE"-If generic data are required for
reregistration, a DCI letter will be enclosed describing such data. If product specific data
are required, another DCI letter will be enclosed listing such requirements. If both generic
and product specific data are required, a combined Generic and Product Specific letter will
be enclosed describing such data. Complete the two response forms provided with each DCI
letter (or four forms for the combined) by following the instructions provided. You must
submit the response forms for each product and for each DCI within 90 days of the date
of this letter (RED issuance date); otherwise, your product may be suspended.
2. TIME EXTENSIONS AND DATA WAIVER REQUESTS-No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for data waivers must be submitted as part of the
90-day response. Requests for time extensions should be submitted in the 90-day response,
but certainly no later than the 8-month response date. All data waiver and time extension
requests must be accompanied by a foil justification. All waivers and time extensions must be
granted by EPA in order to go into effect.
3. APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"-You must
submit the following items for each product within eight months of the date of this letter
(RED issuance date).
i
a. Application for Reregistration (EPA Form 8570-1). Use only an original
application form. Mark it "Application for Reregistration." Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in item 5.
b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
changes, or labeling changes not related to reregistration) separately. You may delete uses
which the RED says are ineligible for reregistration. For further labeling guidance, refer to
the labeling section of the EPA publication "General Information on Applying for Registration
in the U.S., Second Edition, August 1992" (available from the National Technical Information
Service, publication #PB92-221811; telephone number 703-487-4650).
c. Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA
identifier (MRID) numbers. Before citing these studies, you must make sure that they meet
the Agency's acceptance criteria (attached to the DCI).
d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
concentration. You have two options for submitting a CSF: (1) accept the standard certified
limits (see 40 CFR §158.175) or (2) provide certified limits that are supported by the analysis
of five batches. If you choose the second option, you must submit or cite the data for the five
batches along with a certification statement as described in 40 CFR §158.175(e). A copy of
the CSF is enclosed; follow the instructions on its back.
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e. Certification With Respect to Data Compensation Requirements. Complete and
sign EPA form 8570-31 for each product.
4. COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTTCE-Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5. WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
By U.S. Matt:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express;
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVDEWS-EPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections. EPA will try to respond to data
waiver and time extension requests within 60 days. EPA will also try to respond to all 8-
month submissions with a final reregistration determination within 14 months after the RED
has been issued.
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TABLE OF CONTENTS
NUOSEPT 145® REREGISTRATION ELIGIBILITY DECISION TEAM i
EXECUTIVE SUMMARY vi
I. INTRODUCTION 1
H. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile '.'.'. 2
C. Data Requirements 4
D. Regulatory History 4
m. SCIENCE ASSESSMENT 4
A. Physical Chemistry Assessment 4
B. Human Health Assessment 5
1. Toxicology Assessment 5
a. Acute Toxicity 5
b. Subchronic Toxicity 6
c. Developmental Toxicity 6
d. Multagenicity 6
2. Exposure Assessment 7
a. Dietary Exposure 7
b. Occupational and Residential 8
(1) Mixer/Loader/Applicator (Handler) Exposure .... 8
3. Risk Assessment 8
a. Dietary 8
b. Occupational and Residential 8
C. Environmental Assessment 8
1. Environmental Fate 8
a. Environmental Chemistry, Fate and Transport 9
b. Environmental Fate Assessment , . . 9
2. Ecological Effects 9
a. Ecological Effects Data 9
b. Ecological Effects Risk Assessment 10
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 10
A. Determination of Eligibility 10
1. Eligibility Decision 11
2. Eligible and Ineligible Uses „ . 11
B. Regulatory Position 11
1. Personal Protective Equipment (PPE) for Handlers 11
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2. Entry Restrictions for Occupational-Use Products (NonWPS Uses)
12
V. ACTIONS REQUIRED BY REGISTRANTS 12
A. Manufacturing-Use Products 12
1. Additional Generic Data Requirements 12
2. Labeling Requirements for Future Manufacturing-Use Products
13
B. End-Use Products 13
1. Additional Product-Specific Data Requirements 13
2. Labeling Requirements for End-Use Products 14
C. Existing Stocks 15
VI. APPENDICES 17
APPENDIX A. Table of Use Patterns Subject to Reregistration 19
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 23
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of Nuosept 145 31
APPENDIX D. List of Available Related Documents 37
APPENDIX E 41
PRNotice 86-5 43
PR Notice 91-2 61
APPENDIX F. Product Specific Data Call-In . 67
Attachment 1. Chemical Status Sheet 81
Attachment 2. Product Specific Data Call-In Response Forms (Form A
inserts) Plus Instructions 85
Attachment 3. Product Specific Requirement Status and Registrant's
Response Forms (FormB inserts) and Instructions 91
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 97
Attachment 5. EPA Acceptance Criteria 101
Attachment 6. List of All Registrants Sent This Data Call-In (insert) Notice
115
Attachment 7. Cost Share Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 117
APPENDIX G. FACT SHEET 127
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NUOSEPT 145® REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Rafael Prieto
Steve Jarboe
Jihad Alsadek
Environmental Fate and Effects Division
Kathy Monk
Jim Goodyear
Leslie Touart
Man Shamin
Health Effects Division
Flora Chow
Nguyen Thoa
Winston Dang
Patricia McLaughlin
Registration Division
Sami Malak
Mark Perry
Tom Ellwanger
Marshall Swindell
Martha Delaney
Special Review and Reregistration Division
Kathleen Depukat
Kathy Davis
Biological Analysis Branch
Biological Analysis Branch
Economic Analysis Branch
Science Analysis and Coordination Staff
Ecological Effects Branch
Ecological Effects Branch
Environmental Fate and Groundwater Branch
Chemical Coordination Branch
Chemical Coordination Branch
Occupational and Residential Exposure Branch
Toxicology Branch II
Registration Support Branch
Registration Support Branch
Registration Support Branch
Antimicrobial Program Branch
Antimicrobial Program Branch
Accelerated Reregistration Branch
Accelerated Reregistration Branch
Policy & Special Projects Staff
Jean Frane
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Office of Compliance:
Phyllis Flaherty
Office of General Counsel:
Kevin Lee
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GLOSSARY OF TERMS AND ABBREVIATIONS
AE
a.i.
ARC
CAS
CSF
DRES
DWEL
EEC
EP
EPA
FDA
FIFRA
FFDCA
GLC
GRAS
HA
HDT
Acid equivalent
Active Ingredient
Anticipated Residue Contribution
Chemical Abstracts Service
Confidential Statement of Formula
Dietary Risk Evaluation System
Drinking Water Equivalent Level (DWEL) The DWEL represents a medium
specific (i.e. drinking water) lifetime exposure at which adverse, non
carcinogenic health effects are not anticipated to occur.
Estimated Environmental Concentration. The estimated pesticide concentration
in an environment, such as a terrestrial ecosystem.
End-Use Product
U.S. Environmental Protection Agency
Food and Drug Administration
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act
Gas Liquid Chromatography
Generally Recognized As Safe as designated by FDA
Health Advisory (HA) The HA values are used as informal guidance to
municipalities and other organizations when emergency spills or contamination
situations occur.
Highest Dose Tested
m
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LC
50
LD
'50
LEL
LOG
LOEL
MCLG
MP
MPI
MOE
MRID
N/A
NPDES
NOEL
OPP
PADI
PAM
GLOSSARY OF TERMS AND ABBREVIATIONS
Median Lethal Concentration. A statistically derived concentration of a
substance that can be expected to cause death in 50% of test animals. It is
usually expressed as the weight of substance per weight or volume of water, air
or feed, e.g., mg/1, mg/kg or ppm.
Median Lethal Dose. A statistically derived single dose that can be expected to
cause death in 50% of the test animals when administered by the route indicated
(oral, dermal, inhalation). It is expressed as a weight of substance per unit
weight of animal, e.g., mg/kg.
Lethal Dose-low. Lowest Dose at which lethality occurs
Lowest Effect Level
Level of Concern
Lowest Observed Effect Level
Maximum Contaminant Level Goal (MCLG) The MCLG is used by the
Agency to regulate contaminants in drinking water under the Safe Drinking
Water Act.
Manufacturing-Use Product
Maximum Permissible Intake
Margin Of Exposure
Master Record Identification (number). EPA's system of recording and.
tracking studies submitted.
Not Applicable
National Pollutant Discharge Elimination System
No Observed Effect Level
Office of Pesticide Programs
Provisional Acceptable Daily Intake
Pesticide Analytical Method
IV
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PPE
ppm
PRN
RED
REI
RfD
RS
TD
TC
TEP
TGAI
TMRC
TLC
WPS
GLOSSARY OF TERMS AND ABBREVIATIONS
Personal Protective Equipment
Parts Per Million
Pesticide Registration Notice
The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer
Risk Model
Registration Eligibility Decision
Restricted Entry Interval
Reference Dose
Registration Standard
Toxic Dose. The dose at which a substance produces a toxic effect.
Toxic Concentration. The concentration at which a substance produces a toxic
effect.
Typical End-Use Product
Technical Grade Active Ingredient
Theoretical Maximum Residue Contribution
Thin Layer Chromatography
Worker Protection Standard
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EXECUTIVE SUMMARY
The U. S. Environmental Protection Agency (referred to as "the Agency") has
completed an assessment of the potential human health and environmental risks associated with
the pesticide uses of [[[(2-dihydro-5-methyl-3(2H)-oxazolyl)-l-
methylethoxy]methoxy]methoxy] methanol, hereafter referred to as the Nuosept 145® technical
(formerly known as Cosan 145®). The Agency has determined that pesticide products
containing Nuosept 145® as an active ingredient, labeled and used as specified in this
Reregistration Eligibility Decision document (RED), will not cause unreasonable risk to
humans or the environment. Therefore, the Agency has concluded that products containing
Nuosept 145® are eligible for reregistration.
The Nuosept 145® end-use product (EP) is a liquid organic preservative registered for
industrial indoor non-food use in latex paints, resin emulsions, building adhesives, dispersed
colors, pigment slurries, and ready-to-mix joint cements.
Environmental risks from the Nuosept 145® EP use are considered to be negligible due
to the indoor use pattern and the limited ecotoxicology data suggest low toxicity to avian and
aquatic species.
Before reregistering the products containing the Nuosept 145® technical, the Agency is
requiring that product specific data, revised Confidential Statements of Formula (CSF) and
revised labeling be submitted within eight months of the issuance of this document. These data
include product chemistry for each registration and acute toxicity testing. After reviewing
these data and any revised labels and finding them acceptable in accordance with Section
3(c)(5) of FIFRA, the Agency will reregister a product. Those products which contain other
active ingredients will be eligible for reregistration only when the other active ingredients are
determined to be eligible for reregistration.
VI
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
amended to accelerate the reregistration of products with active ingredients registered prior to
November 1, 1984, The amended Act provides a schedule for the reregistration process to be
completed in nine years. There are five phases to the reregistration process. The first four
phases of the process focus on identification of data requirements to support the reregistration
of an active ingredient and the generation and submission of data to fulfill the requirements
The fifth phase is a review by the 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 Nuosept 145® technical. This pesticide chemical was referred to as
Cosan 145® m the Phase 1 list of chemicals subject to reregistration. Since then (1989), the
trade name has changed. The document consists of six sections. Section I is the introduction
Section H describes the Nuosept 145® technical, its uses, data requirements and regulatory
history. Section HI discusses the human health and environmental assessment based on the
^?®aValla^le t0 ±G Agency' Section IV P^sents the reregistration decision for the Nuosept
145 technical. Section V discusses the reregistration requirements for the Nuosept 145®
technical. 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.
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H. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility
Decision document:
Chemical Name:
[[[(2-dihydro-5-methyl-3(2H)-oxazoryl)-l-
methylethoxy]methoxy]methoxy] methanol
• CAS Registry Number:
97553-90-7
OPP Chemical Code:
123702
Empirical Formula:
• Molecular Weight:
C10H21N05
235.28
Trade and Other Names:
Nuosept® 145 technical
Cosan 145® (formerly)
B. Use Profile
The following is information on the currently registered uses with an overview
of use sites and application methods. A detailed table of these uses of Nuosept 145® is
in Appendix A.
For Nuosept 145®:
Type of Pesticide:
Use Sites:
Microbicide/Microbistat (Slime-Forming Bacteria
and Fungi)
INDOOR NON-FOOD:
Industrial Adhesives
Resin/Latex/Polymer Emulsions
Latex (In-Can) Paints
Specialty Industrial Products
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Target Pests:
Slime-forming bacteria and fungi
Formulation Types
Registered: TYPE:
FORM:
Method and Rates of Application:
End Use
Soluble Concentrate/Liquid
Type of Treatment -
Timing -
Rate of Application -
Use Practice Limitations:
(currently on labels)
Industrial preservative treatment
During manufacture, not specified
Industrial Adhesives (building adhesives and
ready-mix joint cements) - 250 to 2500 ppm active
ingredient by weight
Resin/Latex/Polymer Emulsions - 250 to 1000
ppm active ingredient by weight
Latex (In-Can) Paints - 500-1500 ppm active
ingredient by weight
Specialty Industrial Products (dispersed colors and
pigment slurries) - 500 to 1500 ppm active
ingredient by weight
Do not discharge effluent containing this product
into lakes, streams, ponds, estuaries, oceans, or
public waters unless this product is specifically
identified and addressed in accordance with a
NPDES permit. Do not discharge effluent
containing this product to sewer systems without
previously notifying the sewage treatment plant
authority. After biocide addition, the product
should not be subjected to excessively high
temperatures (175° F maximum). This product
must not be used in any connection with feed, food
or drinking water.
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C. Data Requirements
Appendix B includes all data requirements identified by the Agency for
currently registered uses needed to support reregistration.
D. Regulatory History
The Agency first registered a product containing [[[(2-dihydro-5-methyl-3(2H)-
oxazolyl)-l-methylethoxy]methoxy]methoxy] methanol as Cosan 145® in September
1983. The registration was sold and renamed Nuosept 145® (EP). The uses registered
at that time were indoor non-food, latex paints, resin emulsions, building adhesives,
dispersed colors, pigment slurries, and ready-mix joint cements to control bacteria and
slime-forming fungi. These uses represent the same set as are being reregistered in this
Reregistration Eligibility Decision document. There is currently one product registered
with Nuosept 145® technical as the active ingredient. It exists in the product as the sole
active ingredient. No Phase 4 Data Call-In was issued.
ffl. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
The data submitted pertaining to the physical and chemical characteristics of the
Nuosept 145® technical are adequate.
Color:
Physical State:
Odor:
Boiling Point:
Specific Gravity
at 25° C:
Solubility in Water
at 20° C:
Vapor Pressure
at 20° C:
Dissociation Constant:
Yellow
Clear liquid
Pungent
102.4°C
1.079
24 gm/100 ml
1.4x lO
7.7 + 0.4
4
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Octanol/Water Partition
Coefficient: < 10
pH at 25° C: 8.67
Stability: Stable
Human Health Assessment
1. Toxicology Assessment
The Nuosept 145® technical lexicological data base is adequate and will
support reregistration eligibility for the currently registered uses.
a. Acute Toxicity
The acute toxicity data on Nuosept 145® technical (50% a.i.) are
summarized below in Table 1.
Table 1.
Summary of Acute Toxicity Data on Nuosept 145®
Guideline
81-1
81-2
81-3
81-4
81-5
81-6
Description
Oral LD50 - rat
Dermal LD50 - rabbit
Inhalation LC50 - rat
Primary Eye Irritation -
rabbit
Primary Skin Irritation -
rabbit
Dermal Sensitization -
guinea pig
Test Results
1620 mg/kg (F)
1950 mg/kg (M)
4120 mg/kg (M & F)
0.13mg/l/4hr.
Corrosive
Corrosive
No sensitization
Toxicity
Category
III
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i
i
N/A
The acute oral study found ataxia, salivation, and decreased
activity in the dosed rats (MRID 110542). Ataxia and decreased activity
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were also found in the acute dermal study, along with nasal discharge
and anorexia. There was severe irritation in both the epidermis and
dermis of treated skin (MRID 41650401). Rats exposed to inhalation of
the pesticide had gasping and respiratory distress, and in the two higher
doses, decreased activity, nasal discharge, corneal opacity, and lung
erythema (MRID 110541). In a primary eye irritation study, the
Nuosept® 145 technical was corrosive and caused irreversible damage in
unwashed and washed eyes. The test material reacts with proteinaceous
material (MRID 110544). In a primary dermal irritation study Nuosept
145® technical was also corrosive, with a Primary Irritation Score (PIS)
of 7.42/8.00 (MRID 110543). No dermal sensitization was observed in
guinea pigs with Nuosept 145® technical (MRID 110545).
b. Subchronic Toxicity
In a 90-day dermal toxicity study, doses of 0, 150, 500, or 1500
mg/kg/day were applied to rats. The systemic NOEL was 500
mg/kg/day. The LOEL was 1500 mg/kg/day, based on increased
adrenal weights in both sexes; decreased food consumption, body
weight, and weight gain in males; and decreased food efficiency in
females. The NOEL for dermal effects was less than the lowest dose
tested. The LOEL for dermal effects was 150 mg/kg/day. Dermal
irritation occurred in all dose groups in a dose-related manner.
Erythema occurred at all doses and edema at the two higher doses;
hyperkeratosis, inflammation, and ulceration were found in females at
all doses and in males at the two higher doses (MRID 41735601).
c. Developmental Toxicity
In a developmental toxicity study, rats were tested at oral doses
of 0, 100, 400, or 800 mg/kg/day. No developmental effects were
found at any dose and the developmental NOEL was 800 mg/kg/day.
The maternal systemic NOEL was 400 mg/kg/day and the LOEL was
800 mg/kg/day, based on decreased food consumption, body weight, and
body weight gain, along with lethargy and labored respiration (MRID
41757301).
d. Mutagenicity
The mutagenicity data on the Nuosept 145® technical are
summarized below in Table 2.
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Table 2.
Summary of Mutagenicity Data on Nuosept 145®
Study Type
Gene Mutation in vitro
(CHO/HGPRT assay)
Structural Chromosome
Aberration in vitro
(CHO cells)
Structural Chromosome
Aberration in vivo
(mice bone marrow
micronucleus test)
Unscheduled DNA synthesis
in vitro (primary
hepatocytes of rat)
Unscheduled DNA synthesis
in vivo (primary hepatocytes
of rat)
Guideline
84-2
84-2(b)
84-2(b)
84-4
84-4
Results
Negative up to cytotoxic levels, with or
without metabolic activation (MRIDs
41642402 & 41675401)
Positive at high doses tested - 20 /tg/rnl
without activation; 250 /tg/ml with
activation (MRID 41642403)
Negative in mice dosed orally up to toxic
doses, 1200 mg/kg/day (MRID 41948302)
Negative at < 100 #g/ml. Positive at
cytotoxic levels of 200-250 /wg/ml (MRID
41642401)
Negative in rats dosed orally up to toxic
levels of 1800-2400 mg/kg (MRID
41948301)
The Nuosept 145® technical was negative in most mutagenicity
tests, including an in vitro gene mutation test, an in vivo structural
chromosomal aberration test, and an in vivo unscheduled DNA synthesis
test. The chemical was positive in another unscheduled DNA synthesis
only at toxic levels and in an in vitro structural chromosomal aberration
test only at the high doses. The overall results suggest that mutagenicity
health hazards from the Nuosept 145® technical in the expected usage
are minimal.
2. Exposure Assessment
a. Dietary Exposure
No dietary exposure is expected from use of the Nuosept 145®
because its use pattern is indoor non-food use only.
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3.
b. Occupational and Residential
The Nuosept 145® EP is a liquid organic preservative registered
for use in resin emulsions, latex paint, adhesives, dispersed colors,
pigment slurries, and ready-to-mix joint cements. This product is not
registered for agricultural uses. According to the current product label,
the Nuosept 145® EP will protect and preserve raw materials and
finished products at use concentrations ranging from 0.05% to 0.5%
active ingredient.
(1) Mixer/Loader/Applicator (Handler) Exposure
• Based on the pattern of use, several exposure scenarios
are plausible as defined by the type of application equipment and
procedures that may be employed by Nuosept 145® EP handlers.
The current label permits two kinds: open pouring and closed
delivery system application. For those handlers using open
pouring methods without PPE, there is the potential for
respiratory, skin, and eye effects from exposure to Nuosept 145®
EP. Application via closed delivery systems would significantly
reduce any exposure potential.
Risk Assessment
a. Dietary
Human health risk from dietary exposure is not expected because
the Nuosept 145® EP has no food uses.
b. Occupational and Residential
There are no health concerns for non-acute occupational
exposure. The toxicology data base does not indicate any association of
the pesticide with non-acute toxic effects. However, there is a potential
for respiratory, skin and eye effects from acute occupational exposure to
the Nuosept 145® technical. The Nuosept 145® technical is Toxicity
Category I for acute inhalation toxicity and eye/skin irritation.
C. Environmental Assessment
1. Environmental Fate
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a. Environmental Chemistry, Fate and Transport
A hydrolysis study was conducted on the Nuosept 145® technical
which was shown to be stable to hydrolysis at pH 5.0, 7.0 and 9.0.
Other environmental fate studies were not required because
environmental exposure from the current use patterns is unlikely.
b. Environmental Fate Assessment
Due to the indoor use pattern, the Agency did not conduct an
environmental fate assessment for the Nuosept 145® technical.
2. Ecological Effects
The studies that have been submitted are on the 50% soluble
concentrate. Because the technical grade is not registered as a pesticide and
because the chemicals in the other 50% of the formulation is water, the tests on
the 50% soluble concentrate satisfy the reregistration requirements.
a. Ecological Effects Data
Since the Nuosept 145® EP use pattern is entirely indoors, the
Agency reduced the basic data requirements to one avian, one
invertebrate, and one fish toxicity test. The three studies submitted on
the 50% soluble concentrate were all found to be acceptable for use in a
hazard assessment.
Table 3.
Ecological Effects Data Summary
Test Species
Bobwhite Quail
(Colinus virginianus)
Daphnid
(Daphnia magna)
Rainbow Trout
(Salmo gairdneri)
LC5n (ppm)
> 5620
98
280
Conclusions
Practically nontoxic
Slightly toxic
Practically nontoxic
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There is sufficient information to characterize the Nuosept
145® technical as practically nontoxic to birds on a subacute
dietary basis. A single dose oral toxicity study with a Bobwhite
quail (Colinus virginianus} is waived (MRID 160934).
There is sufficient information to characterize the Nuosept
145® technical as being slightly toxic to freshwater invertebrates
(Daphnia magnd) (MRID 160933).
There is sufficient information to characterize the Nuosept
145® technical as being practically nontoxic to freshwater fish,
Rainbow trout (Salmo gairdneri) (MRID 160935).
b. Ecological Effects Risk Assessment
Based on the available data and the use pattern, the
environmental risk is considered to be low. There is no direct use or
application of this pesticide outdoors. Any significant hazard would
presumably result from a transportation accident, spill, or purposeful
discharge into the environment. Any such environmental contamination
would have minimal impact on avian and aquatic species given the
results of the three studies described above.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission
of relevant data concerning an active ingredient, whether products containing the active
ingredients are eligible for reregistration. The Agency has previously identified and
required the submission of the generic (i.e. active ingredient specific) data required to
support reregistration of products containing Nuosept 145® 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 Nuosept 145® technical.
Appendix B identifies the generic data requirements that the Agency reviewed as part of
its determination of reregistration eligibility of the Nuosept 145® technical, 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 the Nuosept 145® technical and to determine that Nuosept 145® technical
can be used without resulting in unreasonable adverse effects to humans and the
environment. The Agency therefore finds that all products containing Nuosept 145® as
the active ingredient are eligible for reregistration. The reregistration of particular
products is addressed in Section V of this document.
10
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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 Nuosept 145® 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 the Nuosept
145® technical, if new information comes to the Agency's attention or if the data
requirements for registration (or the guidelines for generating such data) change.
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredient Nuosept 145®,
the Agency has sufficient information on the health effects of the Nuosept 145® technical
and on its potential for causing adverse effects in fish and wildlife and the
environment. The Agency has determined that Nuosept 145® products, labeled and used
as specified in this Reregistration Eligibility Decision, will not pose unreasonable risks or
adverse effects to humans or the environment. Therefore, the Agency concludes that
products containing the Nuosept 145® technical for all uses are eligible for reregistration.
2. Eligible and Ineligible Uses
The Agency has determined that all registered uses of Nuosept 145®, are
eligible for reregistration.
B. Regulatory Position
The following is a summary of the regulatory positions and rationales for the
Nuosept 145® technical. 'Where labeling revisions are imposed, specific language is set
forth in Section V of this document.
1. Personal Protective Equipment
(Mixer/Loader/Applicators)
(PPE) for Handlers
For each end-use product, PPE requirements for pesticide handlers
will be set during reregistration in one of two ways:
• If the Agency has no special concerns about the acute or other
adverse effects of an active ingredient, the PPE for pesticide
handlers will be based on the acute toxicity of the end-use product.
• If the Agency has special concerns about an active ingredient due
to very high acute toxicity or to certain other adverse effects, such
11
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as allergic effects or delayed effects (cancer, developmental
toxicity, reproductive effects, etc.):
• In the RED for that active ingredient, the Agency may
establish minimum or "baseline" handler PPE requirements
that pertain to all or most occupational end-use products
containing that active ingredient;
• These minimum PPE requirements must be compared with
the PPE that would be designated on the basis of the acute
toxicity of each end-use product;
• The more stringent choice for each type of PPE (e.g.,
bodywear, hand protection, footwear, eyewear, etc.) must
be placed on the label of the end-use product.
There are no special toxicological concerns about Nuosept 145® that
warrant the establishment of active-ingredient-based PPE requirements.
2. Entry Restrictions for Occupational-Use Products (NonWPS Uses)
Exposure to the Nuosept 145® EP treated products, such as
emulsions, latex paints, adhesives, dispersed colors and pigment slurries is
expected to occur. However, the Agency has determined that since the risk
concerns are negligible for exposure to the Nuosept 145® technical as it is
diluted in the treated product, such exposures do not warrant special
restrictions.
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
While there currently is no registered MP, the generic data base supporting
the reregistration of the Nuosept 145® technical for the above eligible uses has
been reviewed and determined to be substantially complete. No additional generic
data are required.
12
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2. Labeling Requirements for Future Manufacturing-Use Products
Effluent Discharge Labeling Statements
All manufacturing-use or end-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.
"Do not discharge effluent containing this product into lakes, streams, ponds,
estuaries, oceans or other waters unless in accordance with the requirements of a
National Pollutant Discharge Elimination System (NPDES) permit and the
permitting authority has been notified in writing prior to discharge. Do not
discharge effluent containing this product to sewer systems without previously
notifying the local sewage treatment plant authority. For guidance contact your
State Water Board or Regional Office of the EPA."
All 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 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. These data include product chemistry for
each registration and acute toxicity testing.
Registrants must review previous data submissions to ensure that they meet
current EPA acceptance criteria (Appendix F; Attachment E) and if not, commit
to conduct new studies. If a registrant believes that previously submitted data meet
current testing standards, then study MRID numbers should be cited according to
the instructions in the Requirement Status and Registrants Response Form provided
for each product.
13
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2. Labeling Requirements for End-Use Products
Personal Protective Equipment and Engineering Controls
The Agency is requiring the following labeling statements to be located on
all end-use products containing Nuosept 145® that are intended primarily for
occupational use:
Application Restrictions:
"Do not apply this product in a way that will contact workers or other
persons, either directly or through drift. Only protected handlers may be
in the area during application."
Engineering Controls:
"When handlers use closed systems, enclosed cabs, or aircraft in a manner
that meets the requirements listed in the Worker Protection Standard (WPS)
for agricultural pesticides [40 CFR 170.260(d) (4-6)], the handler PPE
requirements may be reduced or modified as specified in the WPS."
Although the Agency recognized that the current uses of Nuosept 145® do
not fall within the scope of the WPS, the requirements for engineering controls are
appropriate.
User Safety Requirements:
"Follow manufacturer's instructions for cleaning/maintaining PPE. If no
such instructions for washables, use detergent and hot water. Keep and
wash PPE separately from other laundry."
User Safety Recommendations:
"Users should wash hands before eating, drinking, chewing gum, using
tobacco, or using the toilet."
"Users should remove clothing immediately if pesticide gets inside. Then
wash thoroughly and put on clean clothing."
"Users should remove PPE immediately after handling this product. Wash
the outside of gloves before removing. As soon as possible, wash
thoroughly and change into clean clothing."
14
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Type of Respirator:
If the acute inhalation toxicity of the end-use product is in Category I or II
and, therefore, a respirator is required for pesticide handlers, the following
type of respirator is appropriate to mitigate Nuosept 145® inhalation
concerns:
"A respirator with either an organic-vapor-removing cartridge with a
prefilter approved for pesticides (OSHA/NIOSH approval number prefix
TC-23C), or a canister approved for pesticides (OSHA/NIOSH approval
number prefix TC-14C)."
C. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling
for 26 months from the date of the issuance of this Reregistration Eligibility Decision
(RED). Persons other than the registrant may generally distribute or sell such products
for 50 months from the date of the issuance of this RED. However, existing stocks time
frames will be established case-by-case, depending on the number of products involved,
the number of label changes, and other factors. Refer to "Existing Stocks of Pesticide
Products; Statement of Policy"; Federal Register, Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell Nuosept 145®
products bearing old labels/labeling, i.e., labels absent the modifications specified in this
RED document, except as noted below, for 26 months from the date of issuance of this
RED. Registrants and persons other than the registrants remain obligated to meet
preexisting Agency imposed label changes and existing stocks requirements applicable to
your products.
15
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APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
23
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GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case Nuosept 145 covered by this Reregistration Eligibility Decision
Document. It contains generic data requirements that apply to Nuosept 145 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.
25
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APPENDIX C. Citations Considered to be Part of the
Data Base Supporting the Reregistration of Nuosept 145
31
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GUIDE TO APPENDIX C
CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated
elsewhere in the Reregistration Eligibility Document. Primary sources for studies in
this bibliography have been the body of data submitted to EPA and its predecessor
agencies in support of past regulatory decisions. Selections from other sources
including the published literature, in those instances where they have been considered
are included. '
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 tide (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.
IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID number". This number is unique
to the citation, and should be used whenever a specific reference is required. It is not
related to the six-digit "Accession Number" which has been used to identify volumes of
submitted studies (see paragraph 4(d)(4) below for further explanation). In a few
cases, entries added to the bibliography late in the review may be preceded by a nine
character temporary identifier. These entries are listed after all MRID entries. This
temporary identifying number is also to be used whenever specific reference is needed.
FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the
Agency has shown an identifiable laboratory or testing facility as the author.
When no author or laboratory could be identified, the Agency has shown the
first submitter as the author.
b.
Document date. The date of the study is taken directly from the document.
When the date is followed by a question mark, the bibliographer has deduced
the date from the evidence contained in the document. When the date appears
33
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as (19??), the Agency was unable to determine or estimate the date of the
document.
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.
Trailing parentheses. For studies submitted to the Agency in the past, the
trailing parentheses include (in addition to any self-explanatory text) the
following elements describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the
word "under" is the registration number, experimental use permit
number, petition number, or other administrative number associated
with the earliest known submission.
(3) Submitter. The third element is the submitter. When authorship is
defaulted to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume
in which the original submission of the study appears. The six-digit
accession number follows the symbol "CDL," which stands for
"Company Data Library." This accession number is in turn followed by
an alphabetic suffix which shows the relative position of the study within
the volume.
34
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BIBLIOGRAPHY
MRID
CITATION
110541
110542
110543
110544
110545
160933
160934
160935
41642401
41642402
Voss, K.; Becci, P.; Scott, G.; et al. (1982) Acute LC50 of Cosan 145 in
Sprague-Dawley Rats. (Unpublished study prepared by Food and Drug
Research Laboratories, Inc. submitted by Cosan Chemical Corp., Carlstadt,
NJ).
Reagan, E.; Becci, P. (1982) Acute Oral LD50 Assay in Rats using Cosan 145.
(Unpublished study prepared by Food and Drug Research Laboratories, Inc.,
submitted by Cosan Chemical Corp., Carlstadt, NJ).
Reagan, E.; Becci,, P. (1982) Primary Skin Irritation Study in Albino Rabbits
usig Cosan 145. (Unpublished study prepared by Food and Drug Research
Laboratories, Inc., submited by Cosan Chemical Corp., Carlstadt, NJ).
Reagan, E.; Becci, P. (1982) Primary Eye Irritation Study in Albino Rabbits
using Cosan 145. (Unpublished study prepared by Food and Drug Research
Laboratories, Inc., submitted by Cosan Chemical Corp., Carlstadt, NJ).
Siglin, J.; Becci, P. (1982) Dermal Sensitization Study: Modified Buehler Test.
(Unpublished study prepared by Food and Drug Research Laboratories, Inc.
submitted by Cosan Chemical Corp., Carlstadt, NJ).
Hoberg, J.; Surprenant, D. (1984) Acute Toxicity of Cosan 145 to Daphnids
(Daphnia magna). (Unpublished study prepared by Springborn Bionomics,
Inc.) 13 p.
Stewart, H. (1990) A Dietary LC50 Study in Bobwhite Quail with Cosan 145.
(Unpublished study prepared by Wildlife International). 19 p.
Sousa, J.; Surprenant, D. (1984) Acute Toxicity of Cosan 145 to Rainbow
Trout (Salmo gairdneri). (Unpublished study prepared by Springborn
Bionomics, Inc.) 13 p.
Bakke, J. (1990) Evaluation of the Potential of Cosan 145 to Induce
Unscheduled DNA Synthesis in the In Vitro Hepatocyte DNA Repair Assay
Using the Male F-344 Rat. (Unpublished study prepared by SRI International).
22 p.
Bakke, J. (1990) Evaluation of Cosan 145 in the CHO/HGPRT Gene Mutation
Assay. (Unpublished study prepared by SRI International). 26 p.
35
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BIBLIOGRAPHY
MRID
CITATION
41642403 Blachman, D. (1990) An Assessment of the Clastogenic Potential of Cosan 145
Utilizing the Mammalian Cell Cytogenic Assay with Chinese Hamster Ovary
Cells. (Unpublished study prepared by SRI International). 27 p.
41650401 Reagan, E. (1982) Acute Dermal (LDSO) in Albino Rabbits of Cosan 145.
(Unpublished study prepared by Food and Drug Research Laboratories, Inc.).
342 p.
41671301 Mahoney, D. (1990) Manufacturing Use Product Chemistry Data: Nuosept 145.
(Unpublished study prepared by Huls America, Inc.). 12 p.
41671302 Mahoney, D. (1990) Manufacturing Use Product Chemistry Data: Nuosept 145:
(Unpublished study prepared by Huls America, Inc.). 4 p.
41671901 Campbell, S.; Hoxter, K.; Smith, G. (1990) Nuosept 145: An Acute Oral
Toxicity Study with the Northern Bobwhite: Lab Project Number: 290-104.
(Unpublished study prepared by Wildlife International Ltd.). 19 p.
41675401 Bakke, J. (1990) Evaluation of Cosan 145 in the CHO/HGPRT Gene Mutation
Assay. (Unpublished study prepared by SRI International). 27 p.
41735601 Naas, D. (1990) 90-Day Dermal Study In Rats With Nuosept 145: Lab Project
Number: WIL-159008. (Unpublished study prepared by WIL Research
Laboratories, Inc.). 475 p.
41757301 Nemec, M. (1990) A Developmental Toxicity Study of Nuosept. 145 in Rats:
Final Report: Lab Project Number: WIL-159009. (Unpublished study prepared
by WIL Research Laboratories, Inc.). 347 p.
41824601 Mahoney, D. (1990) Manufacturing Use Product Chemistry Data: Nuosept 145.
(Unpublished study prepared by Huls America, Inc.). 21 p.
41948301 Hamilton, C. (1991) Measurement of Unscheduled DNA Synthesis in Male
Fischer-344 Rat Hepatocytes after in vivo Treatment with Nuosept 145.
(Unpublished study prepared by SRI International). 26 p.
41948302 O'Loughlin, K. (1991) Bone Marrow Erythrocyte Micronucleus Assay of
Nuosept 145 in Swiss-Webster Mice. (Unpublished study prepared by SRI
International). 40 p.
36
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APPENDIX D. List of Available Related Documents
37
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The following is a list of available documents related to Nuosept 145®. It's purpose is
to provide a path to more detailed information if it is needed. These accompanying documents
are part of the Administrative Record for Nuosept 145® 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. Nuosept 145® RED Fact Sheet
4. PR Notice 86-5 (included in this appendix)
5. PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient
Statement
39
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APPENDIX E. PR Notices 86-5 and 91-2
41
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PR Notice 86-5
43
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UNTIED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
July 29,1986
PR NOTICE 86-5
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
NOTICE TO PRODUCERS, FORMULATORS, DISTRIBUTORS
AND REGISTRANTS
Attention:
Subject:
I. Purpose
Persons responsible for Federal registration of
pesticides.
Standard format for data submitted under the
Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) and certain provisions of the Federal
Food, Drug, and Cosmetic Act (FFDCA).
To require data to be submitted to the Environmental
Protection Agency (EPA in a standard format. This Notice also
provides additional guidance about, and illustrations of, the
II. Applicability
This PR Notice applies to all data that are submitted to EPA
to satisfy data requirements for granting or maintaining
pesticide registrations, experimental use permits, tolerances,
aS£L^elat?d approvals under certain provisions of FIFRA and
FFDCA. These data are defined in FIFRA §10 (d) (1) . This Notice
does not apply to commercial, financial, or production
information, which are, and must continue to be, submitted
differently under separate cover.
III. Effective Date
ar,^j ?otiSe is effective on November 1, 1986. Data formatted
according to this notice may be submitted prior to the effective
date. As of the effective date, submitted data packages that do
not conform to these requirements may be returned to the
submitter for necessary revision.
IV. Background
4-1, T,J SePtember 26, 1984, EPA published proposed regulations in
the Federal Register (49 FR 37956) which include Requirements for
Data Submission (40 CFR §158.32), and Procedures for Claims of
Confidentiality of Data (40 CFR §158.33). These regulations
specify. the format for data submitted to EPA under Section 3 of
FIFRA and Sections 408 and 409 of FFDCA, and procedures which
must be followed, to make and substantiate claims of confiden-
tiality. No entitlements to data confidentiality are changed,
either by the proposed regulation or by this notice.
._ . . opp is making these requirements mandatory through this
Notice to gain resource-saving benefits from their use before the
45
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entire proposed regulation becomes final. Adequate lead time is
being provided for submitters to comply with the new
requirements.
V. Relationship of this Notice to Other QPP Policy and Guidance
While this Notice contains requirements for organizing and
formatting submittals of supporting data, it does n9t address the
substance of test reports themselves. "Data reporting" guidance
is now under development in OPP, and will specify how the study
objectives, protocol, observations, findings, and conclusions are
organized and presented within the study report. The data
reporting guidance will be C9mpatible with submittal format
requirements described in this Notice.
OPP has also promulgated a policy (PR Notice 86-4 dated
April 15, 1986) that provides for early screening of certain
applications for registration under FIFRA §3. The objective of
the screen is to avoid the additional C9sts and prolonged delays
associated with handling significantly incomplete application
packages. As of the effective date of this Notice, the screen
will include in its criteria for acceptance of applicati9n
packages the data formatting requirements described herein.
OPP has also-established a public docket which imposes _
deadlines for inserting into the docket documents submitted in
connection with Special Reviews and Registration Standards (see
40 CFR §154.15 and §155.32). To meet these deadlines, OPP is
requiring an additional copy of any data submitted to the docket.
Please refer to Page 10 for more information about this
requirement.
For several years, OPP has required that each application
for registration or other action include a list 9f all_applicable
data requirements and ah indication of how each_is satisfied—the
statement of the method of support f9r the application.
Typically, many requirements are satisfied by reference to data
previously submitted—either by the applicant or by another
party. That requirement is not altered by this notice, which
applies only to data submitted with an application.
VI. Format Requirements
A more detailed discussion of these format requirements
follows the index on the next page, and samples of some of the
requirements are attached. Except for the language 9f the two_
alternative forms of the Statement of Data Confidentiality Claims
(shown in Attachment 3) which cannot be altered, these samples
are illustrative. As long as the required information is
included and clearly identifiable, the form of the samples may be
altered to reflect the submitter's preference.
- INDEX-
A.
B.
C.
D.
Organization of the Submittal Package
Transmittal Document 4
Individual Studies 4
C. 1 Special Considerations for Identifying Studies . . 5
Organization of each Study Volume 6
D. 1 Study Title Page 7
Text Example
Page Page
17
111
17
12
46
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E.
F.
G.
D. 2 Statement of Data Confidentiality Claims
^ , . (based on FIFRA §10(d)(l)) ........ 8
D. 3 Confidential Attachment 8
D. 4 Supplemental Statement of Data Confidentiality
Claims (other than those based on FIFRA. §10 (d) (1) ) 8
D. 5 Good Laboratory Practice Compliance Statement . . 9
Reference to Previously Submitted Data 9
Physical Format Requirements & Number of Copies .... 9
Special Requirements for Submitting Data to the Docket 10
A- Organization of Submittal Package
A "submittal package" consists of all studies submitted at
thetsame time for review in support of a single regulatory
action, along with a transmittal document and other related
^™1Slstra£ive material (e.g. the method of support statement,
EPA Forms 8570-1, 8570-4, 8570-20, etc.) as appropriate.
Data submitters must organize each submittal package as
described in this Notice. The transmittal and any other admin-
istrative material must be grouped together in the first physical
volume. Each study included in the submittal package must then
be bound separately.
Submitters sometimes provide additional materials that are
intended to clarify, emphasize, or otherwise comment to help
Product Managers and reviewers better understand the submittal.
- If such materials relate to one study, they should be
included as an appendix to that study.
- If such materials relate to more than one study (as for
example a summary of all studies in a discipline) or to the
submittal in general, they must be included in the submittal
package as a_separate study (with title page and statement
of confidentiality claims).
B. Transmittal Document
•x-x. ?hf first item in each submittal package must be a trans-
mittal document. This document identifies the submitter or all
joint submitters; the regulatory action in support of which the
package is being submitted—i.e., a registration application,
petition, experimental.use permit (EUP), §3(c)(2)(Bl data
call-in, §6(a)(2) submittalt or a special review; the transmittal
date; and a list of all individual studies included in the
package in the order of their appearance, showing (usually by
Guideline reference number) the data requirement(s) addressed by
each one. The EPA-assigned number for the regulatory action
(e.g. the registration, EUP, or tolerance petition number) should
be included_in the transmittal document as well, if it is known
to the submitter. See Attachment 1 for an example of an
acceptable transmittal document.
_The list of included studies in the transmittal of a data
submittal package supporting a registration application should be
subdivided by discipline, reflecting the order in which data
requirements appear in 40 CFR 158.
.The list of included studies in the transmittal of a data
submittal package supporting a petition for tolerance or an
13
15
14
16
47
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application for an EUP should be subdivided into sections A, B, •
cTT... of the petition or application, as defined in 40.CFR 180.7
and 158.125, (petitions) or Pesticide Assessment Guidelines,
Subdivision I (EUPs) as appropriate.
When a submittal package supports a tolerance petiti9n_and
an application for a registration or an EUP,_ list the_petition
studies first, then the balance of the studies. Within these two
groups of studies follow the instructions above.
C. Individual Studies
A study is the report of a single scientific investigation,
including all supporting analyses required for.logical complete-
ness. A study should be identifiable and distinguishable by a
conventional bibliographic citation including author{ date, and
title. Studies generally correspond in scope to a single Guide-
line requirement for supporting data, with S9me exceptions dis-
cussed in section C.I. Each study included in a submittal
package must be bound as a separate entity. (See comments on
binding studies on page 9.)
Each study must be consecutively paginated, beginning from
the title page as page 1. The total number of pages in the com-
plete study must be shown on the study title page. In addition
(to ensure that inadvertently separated pages can be reassociated
with the proper study during handling or review) use either of
the following:
- Include the total number of pages in the complete study on
each page (i.e., 1 of 250, 2 of 250, ...250 of 250).
- Include a company name or mark and study number on each
page of the study, e g , Company Name-1986-23. Never reuse
a study number for marking the pages of subsequent.studies.
When a single study is extremely long, binding it in_mul-
tiple volumes is permissible so long as the entire study is pag-
inated in a single series, and each yolume is plainly identified
by the study title and its position in the multi-volume sequence.
C.I Special Considerations for Identifying Studies
Some studies raise special problems in study identification,
because they address Guidelines of broader than normal scope or
for other reasons.
a. Safety Studies. Several Guidelines require testing for
safety in more than one species. In these cases each species
tested should be reported as a separate study, and bound
separately.
Extensive supplemental reports of pathology reviews, feed
analyses, historical control data, and the like are often assoc-
iated with safety studies. Whenever possible these should be
submitted with primary reports of the study, and bound with the
primary study as appendices. When such supplemental reports are
submitted independently of the primary report, take care to fully
identify the primary report to which they pertain.
Batteries of acute toxicity tests, performed on the same end
use product and covered by a single title page, may be bound
together and reported as a single study.
b. Product Chemistry Studies. All product chemistry data
within a submittal package submitted in support of an end-use
product produced from registered manufacturing-use,products
should be bound as a single study under a single title page.
Product chemistry data submitted in support of a technical
product, other manufacturing-use product, an experimental use
permit, an import tolerance petition, or an end-use product
48
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produced from unregistered source ingredients, should be bound as
a single study for each Guideline series (61, 62, and 63) for
conventional pesticides, or for the equivalent subject range for
biorational pesticides.. The first of the three studies in a
complete product chemistry submittal for a biochemical pesticide
would cover Guidelines 151-10, 151-11, and 151-12; the second
would cover Guidelines 151-13, 151-15, and 151-16 the third
would cover Guideline 151-17. The first study for a microbial
pesticide would cover Guidelines 151-20, 151-21, and 151-22; the
151-23 and 151-25; the third would
Particularly that .product chemistry studies are likely
?0nf«dentia:i/^?usiness Information as defined in FIFRA
r/-*(B)fc °£.(c>' and lf so must be handled as described
section D.3. of this notice.
, c.; Residue Chemistry Studies. Guidelines 171-4, 153-3,
and 153-4 are extremely broad in scope; studies addressing
residue chemistry requirements must thus be defined at a level
below that of _ the Guideline code. The general principle
iKweyer, of limiting a study to the report of a single inves-
tigation still applies fully. Data should be treated as a single
study and bound separately for each analytical method, each
report of the nature of the residue in a single crop or animal
species, and for each report of the magnitude of residues •
resulting from treatment of a single crop or from processing a
single crop. When more than one commodity is derived from a
single crop ( such _ as beet tops and beet roots) residue data on
all such commodities should be reported as a single study. When
multiple field trials are associated with a single crop, all such
trials should be reported as a single study.
D- Organization of Each Study Volume
4-v -?ach complete study must include all applicable elements in
the list below, in the order indicated. (Also see Page 17 )
Several of these elements are further explained in the following
paragraphs. Entries in the column headed "example" cite the
page number of this notice where the element is illustrated
Element
Study Title Page
Statement of Data
Confidentiality
Claims
Certification of Good
Laboratory Practice
Flagging statements
Body of Study
Study Appendices
Cover Sheet to Confi-
dential Attachment
When Required Example
Always page 12
One of the two alternative Page 13
forms of this statement
is always required
If study reports laboratory Page 16
work subject to GLP require-
ments
For certain t9xicology studies (When
flagging requirements are finalized.)
Always - with an English language
translation if required.
At submitter's option
If CBI is claimed under FIFRA
§10 (d) (1) (A), (B), or (C)
CBI Attachment
Supplemental Statement
of Data Confidentiality
Claims
If CBI is claimed under FIFRA
§10 (d) (1) (A), (B), or (C) Page 15
Only if confidentiality is Page 14
claimed on a basis other than
FIFRA §10 (d) (1) (A), (B), or (C)
49
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D.I. Title Page
A title page is always required for each submitted study,
published or unpublished. The title page must always be freely
releasable to requestors; DO NOT INCLUDE CBI ON THE TITLE PAGE.
An example of an acceptable title page is on page 12 of . this
notice. The following information must appear on the title page:
a. Study title. The study title should be as descriptive as
possible It must clearly identify the substance (s) _ tested and_
correspond to the name of the data requirement as it appears in
the Guidelines .
b. Data requirement addressed . Include on the title page the
Guideline number (s) of the specific requirement ( s ) addressed by
the study.
c. Author ( s _)_ . Cite only individuals with primary _ intellectual
responsibility for the content of the study. Identify . them
plainly as authors, to distinguish them from the performing
laboratory, study sponsor, or other names that may also appear on
the title page.
d. Study Date. The title page must include a single date for
the study. l3T~parts of the study were performed at different
times, use only the date of the latest element in the study.
e. Performing Laboratory Identification. If the study reports
work done by one or more laboratories, include on the title page
the name and address of the performing laboratory or
laboratories, and the laboratory's internal project Dumber (s) for
the work. Clearly distinguish the laboratory's project
identifier from, any other reference numbers provided by the study
sponsor or submitter.
f . Supplemental Submissions . If the study is a commentary on
or supplement to another previously submitted study, or if it
responds to EPA questions raised with respect to an earlier
study, include on the title page elements a. through d. for the
previously submitted study, along with the EPA Master Record
Identifier (MRID) or Accession number. of the earlier study if you
know these numbers. (Supplements submitted in the same submittal
package as the primary study should be appended to and bound with
the primary study. Do not include supplements to more than one
study under a single title page)
! Facts of Publication. If the study is a reprint of a pub-
ished document, identity on the title page all relevant facts of
publication, such as the journal title, volume, issue, inclusive
page numbers, and publication date.
D.2. Statements of Data Confidentiality Claims Under FIFRA
Each submitted study must be accompanied by one of _ the
alternative forms of the statement of Data Confidentiality Claims
specified in the proposed regulation in §158.33 (b) and (c) (See
Attachment 3 ) . These statements apply only to claims of data
confidentiality based on FIFRA §10(d) (1) (A) , (B) , or (C) . Use
the appropriate alternative form of the statement either to
assert a claim of §10(d)(l) data confidentiality (§158.33(b)) or
to waive such a claim (§158 .33 (c) ) . In either case, the
statement must be signed and dated, and must include the typed
name and title of the official who signs it. 09 not make CBI
claims with1 respect to analytical methods associated with pet-
50
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itions for tolerances or emergency exemptions (see NOTE Pg 13).
D.3. Confidential Attachment
_ If the claim is made that a study includes confidential
business information as defined by the criteria of FIFRA
§10(D) (1) (A) , (B), or (C) (as described in D.2. above) all such
information must be excised from the body of the study and
confined to a separate study-specific Confidential Attachment.
Each passage of CBI so isolated must be identified by a reference
number cited within the body of the study at the point from which
the passage was excised (See Attachment 5).
The Confidential Attachment to a study must be identified by
a cover sheet fully identifying the parent study, and must be
clearly marked "Confidential Attachment'." An appropriately
annotated photocopy of the parent study title page may be used as
this cover sheet. Paginate the Confidential Attachment
separately from the body of the study, beginning with page 1 of X
on the title page. Each passage confined to the Confidential
Attachment must be associated with a specific cross reference to
the page(s) in the main body of the study on which it is cited,
and with a reference to the applicable passage(s) of FIFRA
§10(d)(1) on which the confidentiality claim is based.
D-4- Supplemental Statement of Data Confidentiality Claims (See
Attachment 4)
_If you wish to make a claim of confidentiality for any
portion of a submitted study other than described by FIFRA §10(d)
(1)(A), (B), or (C), the following provisions apply:
- The specific inf9rmation to which the claim applies must
be clearly marked in the body of the study as subject to a
claim of confidentiality.
- A Supplemental Statement 9f Data Confidentiality Claims
must_be submitted, identifying each passage claimed confi-
dential and describing in detail the basis for the claim.
A list of the points to address in such a statement is
included in Attachment 4 on Pg 14.
- The Supplemental Statement of Data Confidentiality Claims
must be signed and dated and must include the typed name and
title of the official who signed it.
D.5. Good Laboratory Practice Compliance Statement
This statement is required if the study contains laboratory
work subject to GLP requirements specified in 40 CFR 160. Sam-
ples of these statements are shown in Attachment 6.
E.
Reference to Previously Submitted Data
DO NOT RESUBMIT A STUDY THAT HAS PREVIOUSLY BEEN SUBMITTED
FOR ANOTHER PURPOSE unless EPA specifically requests it. A copy
of the title page plus the MRID number (if known) is sufficient
to allow us t9 retrieve the study immediately for review. This
prevents duplicate entries in the Agency files, and saves you
the cost of sending more copies of the study. References to pre-
viously submitted studies should not be included in the transmit-
tal document, but should be incorporated into the statement of
the method of support for the application.
F.
Physical Format Requirements
All elements in the data submittal package must be on
uniform 8 1/2 by 11 inch white paper, printed on one side only in
black ink, with high contrast and good resolution. Bindings for
individual studies must be secure, but easily removable to permit
disassembly for microfilming. Check with EPA for special
51
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instructions bef9re submitting data_in any medium other than
paper, such as film or magnetic media.
Please be particularly attentive to the following points:
• Do not include frayed or torn pages.
• Do not include carbon copies, or copies in other than
black ink.
• Make sure that photocopies are clear, complete, and
fully readable.
• Do not include oversize computer printouts or fold-out
pages.
• Do not bind any documents with glue or binding tapes.
• Make sure that all pages of each study, including any
attachments or appendices, are present and in correct
sequence.
Number of Copies Required - All submittal packages except
those associated with a Registration Standard or Special Review
(See Part G below) must be provided In three complete, identical
copies. (The proposed regulati9ns specified two copies; three
are now being required to expedite and reduce the cost of
processing data into the OPP Pesticide Document Management System
and getting it into review.)
G. Special Requirements for Submitting Data to the Docket
Data submittal packages associated with a Registration Stan-
dard or Special Review must be provided in four C9pies, from one
of which all material claimed as CBI has been excised. This
fourth copy will become part of the public docket for the RS or
SR case. If no claims of confidentiality are made for the study,
the fourth copy should be identical to the other three. When
portions of a study submitted in support of an RS or SR are
claimed as CBI, the first three copies will include the CBI
material as provided in section D of this notice. The following
special preparation is required for the fourth copy.
• Remove the "Supplemental Statement of Data
Confidentiality Claims".
• Remove the "Confidential Attachment".
• Excise from the body of the study any information you
claim as confidential, even if it does not fall within
the scope of FIFRA §10(d)(1)(A), (B), or (C). Do not
close up or paraphrase text remaining after this
excision.
• Mark the fourth copy plainly on both its cover and its
title page with the phrase "Public Docket Material -
contains no information claimed as confidential".
52
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V.
For Further Information
For further information contact John Carley, Chief,
Inf9rmation Services Branch, Program Management and Support
Division, (703) 305-5240.
/S/
James W. Akerman
Acting Director,
Registration Division
Attachment 1
Attachment 2,
Attachment 3,
Attachment 4,
Attachment 5,
Attachment 6.
Attachment 7,
Sample Transmittal Document
Sample Title Page for a Newly Submitted Study
Statements of Data Confidentiality Claims
Supplemental Statement of Data Confidentiality
Claims
Samples of Confidential Attachments
Sample G9od Laboratory Practice Statements
Format Diagrams for Submittal Packages and Studies
53
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1.
ATTACHMENT 1
ELEMENTS TO BE INCLUDED IN THE TRANSMITTAL DOCUMENT*
Name and address of submitter (or all joint submitters**)
"""Smith. Chemical Corporation
1234 West Smith Street
Cincinnati, OH 98765
-and-
Jones Chemical Company
5678 Wilson Blvd
Covington, KY 56789
""Smith Chemical Corp will act as sole agent for all submitters.
2. Regulatory action in support of which this package is
submit.tea'.
Use the EPA identification number (e.g. 359-EUP-67) if you know
it. Otherwise describe the type of request (e.g. experimental
use permit, data call-in - of xx-xx-xx date).
3. Transmittal date
4. List of submitted studies
Vol 1. Administrative materials - forms, previous corres-
pondence with Project Managers, and so forth.
Vol 2. Title of first study in the submittal (Guideline
No.)
Vol n Title of nth study in the submittal (Guideline
No.)
* Applicants commonly provide this information in a tran-
smittal letter. This remains an acceptable practice so
long as all four elements are included.
* Indicate which of the joint submitters is empowered to
act on behalf of all joint submitters in any matter
concerning data compensation or subsequent use or
release or the data.
Company Official:
Company Name
Company Contact:
Name
Signature
Name
Phone
54
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ATTACHMENT 2
SAMPLE STUDY TITLE PAGE FOR A NEWLY SUBMITTED, STUDY
Study Title ,
(Chemical name) - Magnitude of Residue on Corn
Data Requirement
Guideline 171-4
Author
John C. Davis
Study Completed On
January 5, 1979
Performing Laboratory
ABC Agricultural Laboratories,
940 West Bay Drive
Wilmington, CA 39897
Laboratory Project ID
ABC 47-79
Page 1 of X
(X is the total number of pages in the study)
55
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ATTACHMENT 3
STATEMENTS OF DATA CONFIDENTIALITY CLAIMS
1. No claim of confidentiality under FIFRA §10 (d) (1) (A), (B), or (C) .
STATEMENT OF NO DATA CONFIDENTIALITY CLAIMS
No claim of confidentiality is made for any information contained in this
study on the basis of its falling within the scope of FIFRA
6§10(d) (1) (A), (B), or (C) .
Company
Company Agent:
Title
Typed Name
Date:
Signature
2. Claim of confidentiality under FIFRA §10 (d) (1) (A), (B), or (C) .
Information claimed confidential on the basis of its falling within the
scope of FIFRA §10(d)(1)(A), (B), or (C) has been removed to a
confidential appendix, and is cited by cross-reference number in the body
of the study.
Company:
Company Agent:
Typed Name
Date:
Title
Signature
STATEMENT.OF DATA CONFIDENTIALITY CLAIMS
NOTE: Applicants for permanent or temporary tolerances should
note that it is OPP policy that no permanent tolerance, temporary
tolerance, or request for an emergency exemption incorporating an
analytical method, can be approved unless the applicant waives
all claims of confidentiality for the analytical method. These
analytical methods are published in the FDA Pesticide Analytical
Methods Manual, and therefore cannot be claimed as confidential.
OPP implements this policy by returning submitted analytical
methods, for which confidentiality claims have been made, to the
submitter, to obtain the confidentiality waiver before they can
be processed.
56
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ATTACHMENT 4
SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
For any portion of a submitted study that is not described
by FIFRA §10(d)(1)(A), (B), or (C), but for which y9u claim
C9nfidential treatment on another basis, the following informa-
tion must be included within a Supplemental Statement of Data
Confidentiality Claims:
Identify specifically by page and line number(s)
f the study for which
portion" o
confidentiality.
you claim
each
Cite the reasons why the cited passage qualifies for
confidential treatment.
Indicate the length of time—until a specific date or
event, or permanently—for which the information should
be treated as confidential.
Identify the measures taken to guard against undesired
disclosure of this information.
Describe the extent to which the information has been
disclosed^ and what precautions have been taken in con-
nection with those disclosures.
Enclose C9pies of any pertinent determinations of
confidentiality made by EPA, other Federal agencies, of
courts concerning this information.
If ymi assert that disclosure of this information would
be likely to result in substantial harmful effects to
you, describe tlwse harmful effects and explain why
they should be viewed as substantial.
If you assert that the informati9n in voluntarily sub-
mitted, indicate whether you believe disclosure of this
information might tend to lessen the availability to
EPA of similar information in the future, and if so,
how.
57
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ATTACHMENT 5
EXAMPLES OF SEVERAL CONFIDENTIAL ATTACHMENTS
Example 1. (Confidential word or phrase that has been deleted
from the study)
CROSS REFERENCE NUMBER 1
DELETED WORDS OR PHRASE:
PAGE LINES REASON FOR THE DELETION
REFERENCE
This cross reference number is used in the study in place of the
following paragraph(s) at the indicated volume and page
references.
Ethylene Glycol
FIFRA
6
28
100
14 Identity of Inert Ingredient
25 "
19
§10(d)(C)
Example 2. (Confidential paragraph(s) that have been deleted from the study)
CROSS REFERENCE NUMBER 5
This cross reference number is used in the study in place of the
following paragraph(s) at the indicated volume and page
references.
DELETED PARAGRAPH^):
(
( Reproduce the deleted paragraph(s) here
PAGE
20.
LINES REASON FOR THE DELETION
2-17 Description of the quality control process
FIFRA REFERENCE
§10(d)U)(C)
Example 3. (Confidential pages that have been deleted from the study)
CROSS REFERENCE NUMBER 7
This cross reference number is used in the study in place of the
following paragraph(s) at the indicated volume and page
references.
DELETED PAGES(S): are attached immediately behind this page
PAGES REASON FOR THE DELETION
35-41. Description of product manufacturing process
FIFRA REFERENCE
-------
ATTACHMENT 6.
SAMPLE GOOD LABORATORY PRACTICE STATEMENTS
Example 1.
This study meets the requirements for 40 CFR Part 160
Submitter
Sponsor
Example 2.
This study does not meet the requirements of 40 CFR Part 160, and
differs in the following ways:
1..
2..
3.
Submitter,
Sponsor
Study Director.
Example 3.
The submitter of this study was neither the sponsor of this study nor
conducted it, and does riot know whether it has been conducted in
accordance with 40 CFR Part 160.
Submitter
59
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ATTACHMENT 7.
FORMAT OF THE SUBMITTAL PACKAGE
Transmittal Document
Related Administrative Materials
(e.g. Method of Support Statement, etc.)
Other materials about the submittal
(e.g., summaries of groups of studies
to aid in their review).
Studies submitted as unique
to the format below.
FORMAT OF SUBMITTED STUDIES
•Study title page.
Statement of Confidentiality Claims.
, GLP and flagging* statements - as appropriate.
Body of the study, with English
language translation if required.
Appendices to the study.
Title Page of the Confidential
Attachment.
Confidential Attachment.
Supplemental Statement
of Confidentiality Claims
* When flagging requirements
are finalised.
Documents which must be submitted as
appropriate to meet established requirements.
Documents submitted at submitter's option.
LEGEND
60
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PR Notice 91-2
61
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*
m
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
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:
r, ..- purpose of this notice is to clarify the Office of
Pesticide Program's policy with respect to the statement of
ercentages in a pesticide's label's ingredient statement.
.
- (Percent by weight) of ingredient ( s )
in the ingredient statement on the label must be stated
as the nominal concentration of such ingredient ( s ), as that term
^i-S^V?*40 CFR 158.153(1). Accordingly, the AgJncy hL
established the nominal concentration as the only acceptable
label claim for the amount of active ingredient in the product.
II. BACKGROUND
O-F ,-rt4«l.1i. 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
SSS^S&'^^i*^8^*1 a levei Between t£e upper and the
i™™£? rtif led 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
^I^Sr.i? their Product at the end of the product's shelf-life.
2S£ if \^2t?1X' £his i?d 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
Current regulations require that the percentage listed in
the active ingredient statement be as precise as possible
reflecting go9d manufacturing practices 40 CFR 156. 10 (g) (5) . The
?^roi™d lim:Lts required for each active ingredient are intended
CFR 158 ?vlfc???)S good manufacturing practice" variations 40
-;« ™ uPPer a?£ lower certified .limits, which must be proposed
in connection with a product's registration, -represent the
of an ingredient that may legally be present 40 CFR
The lower certified limit is used as the enforceable
f?rv^? Product composition according to FIFRA
i a)1(i)olC)Li-wh:Lle 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
63
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product composition because the nominal concentration would be
the amount of active ingredient typically found in the product.
It is important for registrants to note that certified
limits for active ingredients are not considered to.be trade
secret information under FIFRA section 10(b).. In this respect the
certified limits will be routinely provided by EPA.to States.for
enforcement purposes, since the nominal concentration.appearing
on the label may not represent the enforceable composition for
purposes of section 12(a)(1)(C).
III. REQUIREMENTS
As described below under Unit V. " COMPLIANCE SCHEDULE," all
currently registered products as well as all applications for new
registration must comply with this Notice by specifying the
nominal 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 pr9vide certified limits
for each active, inert ingredient, impurities of toxicological
significance(i.e., upper limit(s) 9nly) and on a case by case
basis as specified by EPA. These limits are to.be set based, on
representative sampling and chemical analysis(i.e., quality
control) of the product.
The format of the ingredient statement must conform to 40
CFR 156-Labeling Requirements For Pesticides and Devices.
After July 1, 1997, all pesticide ingredient Statements must
be changed to nominal concentration.
IV. PRODUCTS THAT REQUIRE EFFICACY DATA
All pesticides are required to be efficacious. Therefore,
the certified lower limits may not be lower then the minimum
level to achieve efficacy. This is extremely important for
products which are intended to control pests which threaten the
public health, e.g., certain antimicrobial and rodenticide
products. Refer to 40 CFR 153.640.
In those cases where efficacy limits have been established,
the Agency will not accept certified lower limits which are below
that level for the shelf life of the product.
V. COMPLIANCE SCHEDULE
As described earlier, the purpose of this Notice is to make
the registration process more uniform and more manageable tor
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
hiah 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.
64
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(2)
(3)
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.
?ther products/applications that are not subject to
and (2) ab9ve will have until July 1, 1997 to
rJX W:j-th F11^ N9fcice. Such applications should note
'Conversion to Nominal Concentrations on the
£S£j^C;!tlonnlorm-mThese tv£>es Or amendments will not be
handled as "Fast, Track" applications but will be
handled as routine requests .
VI. FOR FURTHER INFORMATION
tffiSaS£ti5°SS
concerning
/s/
Anne E. Lindsay, Director
Registration Division (H-7505C)
65
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APPENDIX F. Product Specific Data Call-in
67
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DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide
products containing the active ingredient identified in
Attachment 1 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 C9ntinued 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 3,
Requirements Statusand Registrant's ResponseForm.
(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 2, Data Call-In Response Form, as well as a
list of all registrants who were sent this Notice (Attachment 6)
The authority for this Notice is secti9n 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 12-31-92).
This Notice is divided into six sections and seven
Attachments. The Notice itself contains information and
instructions applicable to all Data Call-in Notices. The
Attachments contain specific chemical information and
instructions. The six sections of the Notice are:
Section I
Section II
Section III -
Notice
Section IV -
This Notice
Why You Are Receiving This Notice
Data Required By This Notice
Compliance With Requirements Of This
Consequences Of Failure To Comply With
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Registrants' Obligation To Report
Possible Unreasonable Adverse Effects
Inquiries And Responses To This Notice
Section V -
Section VI -
The Attachments to this Notice are:
1
2
3
4
5
6
7
:a call-in Chemical
- Product-Specific Data
Status Sheet
Call-In Response Form
^.c;MUj. Status and Registrant' s Response Form
EPA Grouping of End-Use Products for Meeting Acute
foxicology Data Requirements for Rerecristration
PA Acceptance Criteria
List of Registrants Receiving This Notice
Cost Share and Data Compensation Forms, and Product
Specific Data Report Form
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 II. DATA REQUIREDBY THIS NOTICE
II-A. DATA REQUIRED
The product specific data required by this Notice_are
specified in Attachment 3, 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 3, Requirements Status
and Registrant's Response Form, within the time frames provided.
II-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in
accordance with test standards outlined in the Pesticide Assessment
Guidelines for those studies for which guidelines have been
established.
These EPA Guidelines are available from the National Technical
Information Service (NTIS), Attn: Order Desk, 5285 Port Royal Road,
Springfield, Va 22161 (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, B.C. 20006.
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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 3(c)(2)(B) NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein^ this Data Call-in does not in
any way supersede or chancre the requirements of any previous Data
Call-In(s).or any other agreements entered into with the Agency
pertaining to such prior Notice. Registrants must comply with the
requirements of all Notices to avoid issuance of a Notice of Intent
to Suspend,their affected products.
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
III-A. SCHEDULE FOR RESPONDING 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. . .
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 chose 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 2 and Attachment 3~The Data Call-in Response Form must
be submitted as part of every response to this Notice.In
addition, one copy of the Recruirements Status and Registrant's
Response Form must be submitted for each product listed on the Data
Call-in Response Form unless the V9luntary 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 2). Please note that the company's authorized
representative is required to sign the first page of the Data Call-
in Response Form and Requirements Status and Registrant's Response
Form (if this form, is required)and initial any subsequent pages.
The forms contain separate detailed instructions on the response
options. Do not alter the printed material. If you have questions
or need assistance in preparing your response, call or write the
contact person(s) identified in Attachment 1.
1. yoluntarv 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
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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. 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 Recmirements Status and Registrants Response Form
and item numbers 7a 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. Recruest 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 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 t9 satisfy the product specific data requirementsTi.e. y9u
select item number 7a or 7b), then you must select one of the six
options on the Requirements Status and Registrant's Response Form
related to data production for each data requirement.Your option
selection should be entered under item number 9, "Registrant
Response." The six options related to data production are the
first six options discussed under item 9 in the instructions for
completing the Requirements Status and Registrant's Response Form.
These six options are listed immediately below with information in
parentheses to guide registrants to additional instructions
provided in this Section. The options are:
(1) I will generate and submit data within the specified time
frame (Developing Data)
(2) I have entered into an agreement with one or nupre
registrants to develop data jointly (Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been
submitted previously to the Agency by anyone (Submitting
an Existing Study)
(5) I am submitting or citing data to upgrade a study
classified by EPA as partially acceptable and upgradeable
(Upgrading a Study)
(6) I am citing an existing study that EPA has classified as
acceptable or an existing study that has been submitted
but not reviewed by the Agency (Citing an Existing Study)
Option 1, Developing Data — If you choose to develop the
required data it must be in conformance with Agency deadlines and
with other Agency requirements as referenced herein and in the
attachments. All data generated and submitted must comply with the
G6od 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 y9u cannot submit the data/reports to the Agency in the
time required by this Notice and intend to seek additional time to
meet the requirements ( s ), you must submit a request to the Agency
which includes: (1) a detailed description of the expected
difficulty and (2) a proposed schedule including alternative dates
for meeting such requirements on a step-by-step basis. You must
explain any technical or laboratory difficulties and provide
documentation from the laboratory performing the testing. While
EPA is considering your request, the original deadline remains.
The Agency will respond to your request in writing. If EPA does
not grant your request, the original deadline remains. Normally,
extensions can be requested only in cases of extraordinary testing
problems beyond the expectation or control of the registrant.
Extensions will not be given in submitting the 90-day responses.
Extensions will not be considered if the request for extension is
not .made in a timely fashion <• in no event shall an extension
request be considered if it is submitted at or after the lapse of
the subject deadline.
Option 2, Agreement to Share in Cost to Develop Data
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 tKe
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
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 documentati9n 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
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also submit to the Agency a completed EPA Form 8570-32,
Certification of Offer to Cost Share in the Development of Data,
Attachment 7. In addition, you must demonstrate that the other
registrant to whom the offer was, made has not accepted your offer
to enter into a cost sharing agreement by including a copy of your
offer and proof of the pther 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 arbitrati9n as provided by FIFRA section 3(c) (2) (B) (iii)
and must not qualify this offer. The other registrant must also
inform EPA of its election of an option to develop and submit the
data required by this Notice by submitting a Data Call-in Response
Form and a Requirements Status and Registrant ' s Response Form
committing to develop and submit the data required by this Notice .
In order for you to avoid suspension under this option,
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 t as ( that of the other registrant will normally be subject t9
initiation of suspension proceedings, unless you C9mmit 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, Submitting1 _ 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} .
Y9U should be aware that if the Agency determines that the
study is not acceptable, the Agency will require you t9 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 f9r 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) " 'raw data' means any laboratory
worksheets, records, memoranda, notes, or exact C9pies
there9f, 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
C9pies, computer printouts, magnetic media, including
dictated observations, and recorded data from automated
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:|-ns.truments." 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 9n 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 y?u,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, y9u 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. l-f you have
questions regarding the classification of a study or whether a
study may be upgraded, call or write the contact person listed in
Attachment 1. If you submit data to upgrade an existing study you
must satisfy or_supply information to correct all deficiencies in
the study identified by EPA. You must provide a clearly
articulated rationale of how the deficiencies have been remedied or
corrected and why the study should be rated as acceptable to EPA
Your submission must also specify the MRID number(s) of the study
which you are attempting to upgrade and must be in conformance with
PR Notice 86-5.
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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 9f 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
studythat 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 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 ab9ve 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 would grant a waiver
only under extraordinary circumstances. You should also be aware
that submitting a waiver request will not automatically extend the
due date for the study in question. Waiver requests submitted
without adequate supporting rationale will be denied and the
original due date will remain in force.
IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
IV-A NOTICE OF INTENT TO SUSPEND
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1,
2.
3.
4.
5.
„ —- -sj-.—j may _ issue a Notice of Intent to Suspend products
Ur3e££ to th^-s Notice due to failure by a registrant to comply
w^th 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:
Failure to respond as required by this Notice within 90
days of your receipt of this Notice.
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.
Failure to submit on the required schedule an adequate
progress report on a study as required by this Notice.
Failure to submit on the required schedule acceptable
data as required by this Notice.
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).
Failure to submit supportable certifications as to the
conditions of submitted studies, as required by Section
III-C of this Notice.
Withdrawal of an offer to share in the cost of developing
required data.
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:
inform EPA of intent to develop and submit the data
required by this Notice on a Data Call-In Response
Form and a Requirements Statusahd Registrant's'
Response Formf '
b. fulfill the commitment to develop and submit the
data as required by this Notice; or
c. otherwise take appropriate steps to meet the
requirements stated in this Notice, unless you
commit t9 submit and do submit the required data in
the specified time frame.
Failure to take any required or appropriate steps, not
me.ntl£ned above/ at any time following the issuance of
this Notice.
BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE"
7.
8.
9.
a.
IV-B.
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
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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 ot
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 ot
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 oe
consistent with the Act's purposes. Accordingly, the Agency
anticipates granting registrants permission to sell, distribute, or
Sse existing stocks of Suspended product(s only in exceptional
circumstances. If you believe such disposition 9f existingstocks
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 tne
quantity of existing stocks and your estimate of the time required
for their sale, distribution, and use. Unless.you meet this Tsurden
the Agency will not consider any request pertaining to tne ...
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 tne date your 90.day response to this
Notice is due to sell, distribute, or use existing stocks.
Normally7 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 hasparticular risk concerns will be determined on case-by-
case basis.
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Requests for voluntary cancellation received after the 90 dav
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 fciith 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
*-v *. Registrants t are reminded that FIFRA section 6 (a) (2) states
£ iJ-a- an¥ lime a?ter a Pesticide is: registered a registrant
ff 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: riot 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. v^-ue
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and
procedures established by this Notice, call the contact person(s)
listed in Attachment 1, the Data Call-in Chemical Status Sheet
All responses to this Notice (other than voluntary
cancellation requests and generic data exemption claims) must
include a completed Data. Call-In Response Form and a completed
Requirements gtatus and Registrant's Response Form (Attachment 2
and Attachment. 3 Jror. product specific data) and any other documents
required by this Notice, and should be submitted to the contact
person(s).identified in Attachment 1. If the voluntary
cancellation or generic data exemption option is chosen, only the
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,
.-7
Louis P. True, Jr., Acting Director
Special Review and
Reregistration Division
Attachments
2
3
4
- Data Call-in Chemical Status Sheet
- Product-Specific Data Call-in Response Form
- Requirements Status and Registrant's Response Form
- EPA Grouping of End-Use Products for Meeting Acute
Toxicology Data Requirements for Rerecristration
79
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5
6
7
- EPA Acceptance Criteria
- List of
- Cost
Registrants
are and Data
Receiving This
Specific Data Report Form
Compensation Forms
Notice
and
Product
80
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Attachment 1. Chemical Status Sheet
81
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NUOSEPT® 145 DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-in Notice
because you have product(s) containing Nuosept® 145.
This Product Specific Data Call-In Chemical Status Sheet.
contains an 9veryiew of data required by this notice, and point of
contact for inquiries pertaining to the reregistration of Nuosept®
145. This attachment is to be used in conjunction with (1) the
Product Specific Data Call-in Notice, (2) the Product Specific Data
Call-in_Response Form (Attachment 2), (3) the Requirements Status
and Registrant's Form (Attachment 3), (4) EPA's Grouping of End-Use
Products for Meeting Acute Toxicology Data Requirement (Attachment
4),_(5) the EPA Acceptance Criteria (Attachment 5), (6) a list of
registrants receiving this DCI (Attachment 6) and (7) the Cost
Share and Data Compensation Forms in replying to this Nuosept® 145
Pr9duct Specific Data Call-in (Attachment 7). Instructions and
guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the
database for Nuosept® 145 are contained in the Requirements Status
and Registrant's Response. Attachment 3. The Agency has concluded
that additional data on Nuosept® 145 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 Nuosept® 145 products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of
Nuosept® 145, please contact Kathleen Depukat at (703) 308-8587.
,If you have any questions regarding the product specific data
requirements and procedures established by this Notice, please
c2nta££-,Franklin Gee at <703) 308-8008 or Emily Mitchell at (703)
308-8583.
All responses to this Notice for the Product Specific data
requirements should be submitted to:
Emily Mitchell
Chemical Review Manager Team 81
Product Reregistration Branch
Special Review and Reregistration Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, B.C. 20460
RE: Nuosept® 145
83
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Attachment 2. Product Specific Data Call-in
Response Forms (Form A inserts) Plus
Instructions
85
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Item 6.
INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN 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).
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 registration 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.
For each manufacturing use product (MUP) for which you wish
to maintain registration, you must agree to satisfy the
data requirements by responding "yes."
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.
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 canceled this product. For these
cases, please supply all relevant details so that EPA can
ensure that its records are correct.
Item 7a.
Item 7b.
NOTE;
87
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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 guideline reference numbers of studies required to
support the product's continued registration are
identified. These guidelines, in addition to the
requirements specified xn 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 pattern(s) of the pesticide ass9ciatedtwith 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 the
Reregistration Eligibility Document 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
datarequirements 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. By the
specified due date, I will also submit: (1) a completed
"Certification With Respect To Data Compensation
Requirements11 form (EPA Form 8570-29) and (2) two completed
and signed copies of the Confidential Statement of Formula
(EPA Form 8570-4).
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 only 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 agreement is committing to submit or p^vide
the required data; if the required study is n9t submitted
on time, my product may be subject to suspension. By the
specified due date, I will also submit: (1) a completed
"Certification With Respect To Data Compensation
88
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Requirements™ form (EPA Form 8570-29) and (2) two completed
and signed copies of the Confidential Statement of Formula
(EPA Form 8570-4).
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 required data; if the required study is not
submitted on time, my product may be subject to suspension.
I understand that other terms under Option 3 in the Data
CallTIn Notice (Section III-C.l.) apply as well. By the
specified due date, I will also submit: (1) a completed
"Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed
and signed copies of the Confidential Statement of Formula
(EPA Form 8570-4).
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 III-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. By the
specified due date, I will also submit a completed
"Certification With Respect To Data Compensation
Requirements'" form (EPA Form 8570-29) to show what data
compensation option I have chosen. By the specified due
date, I will also submit: (1) a completed "Certification
With Respect To Data Compensation Requirements" form (EPA
Form 8570-29) and (2) two completed and signed copies of
the Confidential Statement of Formula (EPA Form 8570-4).
By the specified due date, I will submit or cite data to
upgrade a study classified by the Agency as partially
acceptable and upgradable (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 III-C.l.) apply. By the specified due
date, I will also submit: (1) a completed "Certification
With Respect To Data Compensation Requirements" form (EPA
Form 8570-29) and (2) two completed and signed copies of
the Confidential Statement of Formula (EPA Form 8570-4).
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
89
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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 C9nducted on my product, an
identical product or a product which EPA has "grouped" with
one or more other products for purposes of depending 9n 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) for the cited data on a "Product
Specific Data Report" form or in a similar format. By the
specified due date, I will also submit: (1) a completed
"Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed
and signed copies of the Confidential Statement of Formula
(EPA Form 8570-4) .
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 required to
supply the data pursuant to Section 3(c)(2)(B) of FIFRA.
If the Agency denies my waiver request, I must choose a
method of meeting the data requirements of this Notice by
the due date stated by this Notice. In this case, I must,
within 30 days of my receipt of the Agency's written
decision, submit a revised "Requirements Status and
Registrant's Response" Form indicating the option chosen.
I also understand that the deadline for submission of data
as specified by the original data call-in notice will not
change. By the specified due date, I will also submit: (1)
a completed "Certification With Respect To Data
Compensation Requirements" form (EPA Form 8570-29)_and (2)
two completed and signed copies of the Confidential
Statement of Formula (EPA Form 8570-4) .
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 canceled this product. For these
cases, please supply all relevant details so that EPA can
ensure that its records are correct.
90
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Attachment 3. Product Specific Requirement
Status and Registrant's Response Forms (Form
B inserts) and Instructions
91
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STATOS
«•«•»»«••
Item1-3-
Item 4.
Item 5
Item 6,
Item 7
Item 8
Item 9
SS.
response
The guidelines reference numbers of studies required to
fS8??$4 ^the 5£foduct's.^ ?9"tinued regiltratTon arS
identified. These guidelines, in addition to the
requirements specified In the Notice, govern the conduct of
rir tudies- Note that series 61 and 62 in
title associated with the guideline reference
-^ io.entified.
~~^*-r~Z Patters (s) of the pesticide associated with the
product specific requirements is (are) identified. For
most product specific data requirements, all use patterns
a£|,c°y®rej?.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?
The substance .to be tested is identified by EPA For
?«S x* i-sp-lcif-lc d?ta',the Product as formulated for sale
and dlstribut:LOn 1S the test substance, except in rare
CciSGS .
i«, ™t1ifo^sul2nissi2n of each study is identified.
«™- norm^llyc,-Ib.as.td.n?n 8 months after issuance of the
Reregistration Eligibility Documents unless EPA determines
tnat a longer time period is necessary.
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-
-Lxi JWOdCS a
!?enerate and submit data by the specified due
hi oonP:ifg Da^ai* By indicatWthat I have choseS
this_ option, I certify that I will comply with all the
33XiSE!rtSH Pert1a1ipinf to the conditions^for submittal of
this study as outlined in the Data Call-in Notice.
haye entered into an. agreement with one or more
ants to develop data jointly (Cost Sharing) . I am
h « a c°Py °fwthis agreement. I understand that
this option is available on £9r acute toxicity or certain
HEf« ™&2at?>,a?d °nly if EPA indicates in an attachment to
Snrfi^? ^ JSltfniy*profe?t 1S similar- Enough to another
SfSSS-0?^0-!,911*13-^' for-this option. I certify that another
party in the agreement is committing to submit or provide
S^-TS?11^ da^a; if the required Itudy is nSt suESi?ted
on time, my product my be subject to suspension.
j**. ?^J^ave made offers to share in the cost to
ata ,1°."^ to Cost Share) . I understand that .this
available only for acute toxicity or certain efficacv
a and only i< EPA indicates in an attachment to this
thS «SflN^iCie that my Product is similar enough tS
another product to qualify for this option. I am
93
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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 III-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 III-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 III-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 it 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 registratrant's data, I
will submit a completed "Certification With Respect To Data
Compensation Requirements" form.
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
94
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°f my- rec^Pt 9f the Agency's written decision,
nof*reXXSfedi *. Retirements Status chosen. I also
understand that the .deadline for submission of data as
specified by the original data cal-in notice will not
, cnange.
Items 10-13. Self-explanatory.
NffFJL;Yo-u may Provide additional information that does not fit on
° a sWed ietter that accompanies this form. For
you may wish to report that your product has alreadv been
"& -t0 ano>her company or that you Save alreSdy vS!3ntaril?
this product. For these cases, please supply all relevant
details so that EPA can ensure that its records are correct.
95
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Attachment 4. EPA Batching of End-Use
Products for Meeting Data Requirements for
Reregistration
97
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KEREGISTRATION
„ . ?ecaus® there is only one end-use product at this time
containing the active ingredient Nuosept 145®, no toxicology batchina
is required.
99
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Attachment 5. EPA Acceptance Criteria
101
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SUBDIVISION D
Guideline
Series 61
Series 62
Series 63
Study Title
Product Identity and Composition
Analysis and Certification of Product Ingredients
Physical aid Chemical Characteristics
103
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61 Product Identify and Composition
ACCEPTANCE CRITERIA
Docs 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 f9r each impurity or each group of impurities present at > 0.1 % by weight and
for certain lexicologically significant impurities (e.g., dioxins, nitrosamines) present aF <0.1 %.
4. Purpose of each active ingredient and each intentionally-added inert.
5, Chemical name from Chemical Abstracts index of Nomenclature and Chemical Abstracts Service (CAS)
Registry Number for each active ingredient and, if available, for each intentionally-added inert.
6. Molecular, structural, and empirical formulas, molecular weight or weight range, and any company assigned
experimental or internal code numbers for each active ingredient.
7. Description of each beginning material in the manufacturing process.
EPA Registration Number if registered;
for other beginning materials, the following:
Name and address of manufacturer or supplier.
Brand name, trade name or commercial designation.
Technical specifications or data sheets by which manufacturer or supplier describes composition,
properties or toxicity.
8. Description of manufacturing process.
Statement of whether batch or continuous process. _
Relative amounts of beginning materials and order in which they are added.
Description of equipment.
Description of physical conditions (temperature, pressure, humidity) controlled in each step and the
parameters that are maintained.
Statement of whether process involves intended chemical reactions.
Flow chart with chemical equations for each intended chemical reaction.
Duration of each step of process.
Description of purification procedures.
Description of measures taken to assure quality of final product.
9. Discussion of formation of impurities based on established chemical theory addressing (1) each impurity which
may be present at > 0.1% or was found at >_ 0.1% by product analyses and (2) certain lexicologically
significant impurities~(see #3).
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62 Analysis and Certification of Product Ingredients
2.
3."
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 %.
Degree of accountability or closure > ca98%.
Analyses conducted for certain trace toxic impurities at lower man 0.1% (examples, nitrosamines in the case of
products containing dinitroanilines or containing secondary or tertiary amines/alkanolamines plus nitrites;
polyhalogenated dibenzodioxiris and dibenzofurans). [Note that in the case of nitrosamines both fresh and stored
samples must be analyzed.].
Complete and detailed description of each step in analytical method used to analyze above samples.
Statement ofprecisipn and accuracy of analytical method used to analyze above samples.
Identities ana quantities (including mean and standard deviation) provided for each analyzed ingredient.
Upper and lower certified limits proposed for each active ingredient and intentionally added inert along with
explanation of Irow the limits were determined.
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.
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.
Analytical methods (as discussed in y9) to verify certified limits validated as to their precision and accuracy.
4.
5.-
6."
9.
10.
105
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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.
c
Docs your study meet the following acceptance criteria?
63-2 Color
Verbal description of coloration (or lack of it)
Any intentional coloration also reported in terms of Munsell color system
63-3 Physical State
Verbal description of physical state provided using terms such as "solid, granular, volatile liquid
Based on visual inspection at about 20-25 ° C
63-4 Odor
Verbal description of odor (or lack of it) using terms such as "garlic-like, characteristic of aromatic
compounds"
Observed at room temperature
63-5 Melting Point
Reported in °C
Any observed decomposition reported
63-6 Boiling Point
, 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 hi 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 Ibs/fr or
Ibs/gallon.]
63-8 Solubility
Determined in distilled water and representative polar and non-polar solvents, including those used in
formulations and analytical methods for the pesticide
Measured at about 20-25° C
Reported in g/100 ml (other units like ppm acceptable if sparingly soluble)
63-9 Vapor Pressure
Measured at 25° C (or calculated by extrapolation from measurements made at higher temperature if pressure
too low to measure at 25 ° C)
Experimental procedure described
Reported hi mm Hg (torr) or other conventional units
63-10 Dissociation Constant
Experimental method described
Temperature of measurement specified (preferably about
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
106
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Guideline
81-1
81-2
81-3
81-4
81-5
81-6
SUBDIVISION F
Study Title
Acute Oral Toxicity in the Rat
Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
Acute Inhalation T9xicity in the Rat
Primary Eye Irritation in the Rabbit
Primary Dermal Irritation Study
Dermal Sensitization in the Guinea Pig
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81-1 Acute Oral Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. At least 5 young adult rats/sex/group.
3. Dosing, single oral may be administered over 24 hrs.
4." "Vehicle control if other than water. /fnnn /, s
5. Doses tested, sufficient to determine a toxicity category or a limit dose (5000 rag/kg).
6.Individual observations at least once a day. . .
7. Observation period to last at least 14 days, or until all test animals appear normal whichever is longer.
8. Individual daily observations.
9. Individual body weights.
10. Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be required for every study.
108
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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?
Identify material tested (technical, end-use product, etc).
At least 5 animals/sex/group.
Rats 200-300 gm, rabbits 2.0-3.0 kg or guinea pigs 350-450 gm.
Dosing, single dermal.
Dosing duration at least 24 tours.
Vehicle control, only if toxicity of vehicle is unknown.
Doses tested, sufficient to determine a toxicity category or a limit dose (2000 mg/kg).
Application site clipped or shaved at least 24 nours before dosing.
Application site at least 10% of body surface area.
Application site covered with a porous nonirritating cover to retain test material and to prevent
11- Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be required for every study.
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81-3 Acute Inhalation Toxicity in the Rat
ACCEPTANCE CRITERIA
Docs your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Product is a gas, a solid which may produce a significant vapor hazard based on toxicity and expected use or
•_— contains particles of inhalable size for man (aerodynamic diameter 15 pm or less).
3. At least 5 young adult rats/sex/group.
4; ~ Dosing, at least 4 hours by inhalation.
5 Chamber air flow dynamic, at least 10 air changes/hour, at least 19% oxygen content.
6." ; Chamber temperature, 22° C (+2°), relative humidity 40-60%.
7. Monitor rate of air flow.
8. Monitor actual concentrations of test material in breathing zone.
9; Monitor aerodynamic particle size for aerosols. .
10.- Doses tested, sufficient to determine a toxicity category or a limit dose (5 mg/L actual concentration ol 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.
110
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81-4 Primary Eye Irritation in the Rabbit
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
!• 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 (he conjunctiva! sac of one eye
per animal.
•?• P°.s,e' O-1 mlifaliquid; 0.1 ml or not more than 100 mg if a solid, paste or participate substance.
6. Solid or granular test material ground to a fine dust. "»*•*•
7. Eyes not washed for at least 24 hours.
8- %es examined and graded for irritation before dosing and
at 1, 24, 48 and 72 hr, then daily until eyes are normal
or 21 days (whichever is shorter).
9.* Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
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81-5 Primary Dermal Irritation Study
ACCEPTANCE CRITERIA
Docs your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, eto).
2. ' Study not required if material is corrosive or has a pH of <2 or ^11.3.
3. 6 adult animals.
4. Dosing, single dermal.
5, Dosing duration 4 hours. .
6. Application site shaved or clipped at least 24 hours pnor 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. .... ^., , , A .
10. ApplicaSsite examined and graded for irritation at 1, 24, 48 and 72 hr, then daily until normal or 14 days
(whichever is shorter).
11,* Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
JL.XA
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81-6 Dermal Sensitization in the Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1.
2.'
4.
5.*
6.-
7."
Identify material tested (technical, end-use product, etc).
Study not required if material is corrosive or has a
pHof <2or >11.5.
One offfie 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.
Complete description of test.
Reference for test.
Test followed essentially as described in reference document.
Positive control included (may provide historical data conducted within the last 6 months).
Criteria marked with an * are supplemental and may not be required for every study.
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Attachment 6. List of All Registrants Sent This Data Call-In (insert) Notice
115
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Attachment 7. Cost Share Data Compensation Forms, Confidential
Statement of Formula Form and Instructions
117
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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.
If any block is not applicable, mark it N/A.
The CSF must be signed, dated and the telephone number of the responsible party must be provided.
All applicable information which is on the product specific data submission must also be reported on the
CSF.
b.
c.
d.
e.
f.
g.
h.
i.
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k.
1.
m.
n.
All weights reported under item 7 must be in pounds per gallon for liquids and pounds per cubic feet for
solids.
Flashpoint must be in degrees Fahrenheit and flame extension in inches.
For all active ingredients, the EPA Registration Numbers for the currently registered source products
must be reported under column 12.
The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all common names for the
trade names must be reported.
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 laoel.
All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or grams. In no case will
volumes be accepted. Do not mix English and metric system units (i.e., pounds and kilograms).
All the items under column 13.b. must total 100 percent.
All items under columns 14.a. and 14.b. for the active ingredients must represent pure active form.
The upper and lower certified limits for ail active and inert ingredients must follow the 40 CFR 158.175
instructions. An explanation must be provided if the proposed limit
limits.
limits are different than standard certified
When new CSFs are submitted and approved, all previously submitted CSFs become obsolete for that
specific formulation.
121
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svEPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OMB No. 2070-0106
2070-0057
Approval Expires 3-31-96
Public reporting burden for this collection of Information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W.. Washington, DC 20460; and to the Office
of Management and Budget. Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Please fill in blanks below.
Company Name
Company Number
EPA Reg. No.
I Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data.
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
Name of Flrm(»)
Date of Offer
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company1* Authorized Representative
Dale
Name and Title (Please Type or Print)
EPA Form 8570-32 (5/91) Replaces EPA Form 8580, which is obsolete
123
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&EPA
Stitas Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
^ ^ •*•••• • • fa»*Mp er aw^** 9 § ^gv
COMPENSATION REQUIREMENTS
OMB N*. 3070-0107
2070-0037
_^^___^_^^^^ 3-31-96
In* PM»!if« Infonnatton, including suggestions for reducing this burden to Chief Information Policy
5 ' U^einant kndrfiSlil^II!?*1 "HSK.^?**401 M St> S'W- WwWnflto". DC 20460: and to the Office
of Management and Budget. Paperwork Reduction Project <207 and Tltta
Typ» or Print)
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APPENDIX G. FACT SHEET
127
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United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-94-027
September 1994
R.E.D. FACTS
Pesticide
Reregistration
Use Profile
Nuosept 1
All pesticides sold or distributed in the United States must be
registered by EPA, based on scientific studies showing that they can be used
without posing unreasonable risks to people or the environment. Because of
advances in scientific knowledge, the law requires that pesticides which
were first registered years ago be reregistered to ensure that they meet
today's more stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency imposes
any regulatory controls that are needed to effectively manage each
pesticide's risks. EPA then reregisters pesticides that can be used without
posing unreasonable risks to human health or the environment.
When a pesticide is eligible for reregistration, EPA announces this and
explains why in a Reregistration Eligibility Decision (RED) document. This'
fact sheet summarizes the information in the RED document for
reregistration case 3052, [[[(2-dihydro-5-methyl-3(2H)-oxazolyl)-l-
methylethox3^]methoxy]methoxy] methanol, hereafter referred to as Nuosept
145® (formerly known as Cosan 145®).
Nuosept 145® is a liquid organic preservative registered for industrial
indoor, non-food use in latex paint (in can), resin emulsions, building
adhesives, dispersed colors, pigment slurries and ready-to-mix joint
cements. This microbiocide/microbiostat is used to control slime-forming
bacteria and fungi. The two application methods for Nuosept 145® include
open pouring and closed delivery systems.
Current use practice limitations prohibit discharge of effluent
containing Nuosept 145® into streams, ponds, estuaries, oceans or public
waters unless this product is specifically identified and addressed in a
National Pollutant Discharge Elimination System (NPDES) permit and the
sewage treatment plant authority has been notified. After the biocide has
been added to a product, it should not be subject to temperatures above 175°
F. Finally, Nuosept 145® must not be used in connection with feed, food or
drinking water.
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Regulatory The Agency first registered a pesticide product containing [[[(2-
HistOiy dihydro-5-methyl-3(2H)-oxazolyl)-l-methylethoxy]methoxy]methoxy]
methanol, referred to as Cosan 145®, in 1983. The registration was sold
and renamed Nuosept 145®. The original uses registered are the same uses
included under the Reregistration Eligibility Decision for Nuosept 145®.
Currently, there is only one end use product registered containing Nuosept
145® technical as the (sole) active ingredient.
Human Health
Assessment
Toxicity
Nuosept 145® technical is highly acutely toxic and can cause severe
respiratory, eye and skin effects. It is classified in Toxicity Category I for
acute inhalation toxicity and primary eye and skin irritation (Category I
indicates the highest level of acute toxicity). Nuosept 145® poses minimal
mutagenicity risks and no subacute, chronic or developmental toxicity
concerns.
Dietary Exposure
There are no food uses for Nuosept 145®, therefore, no dietary
exposure is expected.
Occupational and Residential Exposure
The current Nuosept 145® product label permits application by open
pouring and closed delivery system. Handlers using open pouring methods
without Personal Protective Equipment (PPE) face potential respiratory, eye
and skin effects from exposure to this acutely toxic pesticide. Application
via closed delivery systems significantly reduces potential exposure and risk.
Human Risk Assessment
Nuosept 145® is not registered for any food or feed related uses, so no
dietary risks are posed.
There are no health concerns for residential exposure or for long-term
occupational exposure. However, there is a potential for acute respiratory,
skin and eye effects from occupational exposure to the Nuosept 145®
technical, particularly from the open pouring method of application.
Therefore, the Agency is requiring the use of PPE for handlers using this
method of application.
Environmental
Assessment
Environmental Fate
Nuosept 145® technical is stable to hydrolysis at several pH levels.
Other environmental fate studies were not required because current use
patterns are unlikely to result in environmental exposure.
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Additional Data
Required
Product Labeling
Changes Required
Regulatory
Conclusion
For More
Information
Ecological Effects
Nuosept 145® technical is practically nontoxic to birds on a subacute
dietary basis, and practically nontoxic to freshwater fish on an acute basis.
It is slightly toxic to freshwater invertebrates.
Ecological Effects Risk Assessment
Based on available data and considering its use patterns, the
environmental risk posed by Nuosept 145® is believed to be low. Nuosept
145® is used entirely indoors; there is no direct use or application of this
pesticide outdoors. Any significant hazard would presumably result from a
transportation accident, spill, or purposeful discharge into the environment.
Any such environmental contamination would have minimal impact on avian
and aquatic species.
EPA is requiring product-specific data including product chemistry
and acute toxicity studies, a revised Confidential Statement of Formula
(CSF), and revised product labeling for reregistration of the product
containing Nuosept 145® technical.
The label of the registered pesticide product containing Nuosept 145®
must comply with EPA's current pesticide labeling requirements.
Use of the currently registered product containing Nuosept 145® in
accordance with approved labeling will not pose unreasonable risks or
adverse effects to humans or the environment. Therefore, all uses of this
product are eligible for reregistration. The product will be reregistered
once the required product-specific data, revised Confidential Statement of
Formula and revised labeling are received and accepted by EPA.
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for Nuosept 145® during a 60-day time period, as
announced in a Notice of Availability published in the Federal Register. To
obtain a copy of the RED document or to submit written comments, please
contact the Pesticide Docket, Public Response and Program Resources
Branch, Field Operations Division (7506C), Office of Pesticide Programs
(OPP), US EPA, Washington, DC 20460, telephone 703-305-5805.
Electronic copies of the RED and this fact sheet can be downloaded
from the Pesticide Special Review and Reregistration Information System at
703-308-7224, and also from the Internet via FEDWORLD.GOV and EPA's
gopher server, EARTH1 .EPA. GOV.
Following the comment period, the Nuosept 145® RED document will
be available from the National Technical Information Service (NTIS), 5285
Port Royal Road, Springfield, VA 22161, telephone 703-487-4650.
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For more information about EPA's pesticide reregistration program,
the Nuosept 145® RED, or reregistration of the individual product
containing Nuosept 145, 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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