Untied States Prevention, Pesticides, EPA738-S-93-012
Environmental Protection And Toxic Substances September 1993
Agency (H7508W)
&EPA Registration
Eligibility Decision (RED)
Cedarwood Oil
Printed on Recycled Paper
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TABLE OF CONTENTS
WOOD OILS AND GUMS REREGISTRATION ELIGIBnJTY DECISION
TEAM .' i
GLOSSARY OF TERMS AND ABBREVIATIONS ii
EXECUTIVE SUMMARY - . iv
I. INTRODUCTION 1
H. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile . 2
C. Data Requirements 3
D. Regulatory History 4
m. SCIENCE ASSESSMENT . 5
A. Physical Chemistry Assessment 5
IV. RISK MANAGEMENT AND REREGISTRATION ELIGIBILITY
DECISION 6
A, Determination of Reregistration Eligibility 6
1. Eligible and Ineligible Uses 7
B. Risk Management Decision 7
V. ACTIONS REQUIRED BY REGISTRANTS 8
A. Technical Grade Information 8
1. Generic Data Requirements 8
B. End-Use Products 8
1. Additional Product-Specific Data Requirements 8
2. Labeling Requirements for End-Use Products 9
A. Existing Stocks 9
VI. APPENDICES
Appendix A -Usr Patterns Subject to Reregistration
Appendix B - Table of the Generic Data Requirements and Studies Used to Make the
Reregistration Decision
Appendix C - Citations Considered to be Part of the Data Base Supporting the
Reregistration of Wood Oils and Gums
Appendix D - List of Available Related Documents
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Appendix E - Pesticide Reregistration Handbook
Appendix F - Generic Data Call-in
Attachment A - Chemical Status Sheet
Attachment B - Generic DCI Response Forms (Form A) plus Instructions
Attachment C - Requirements Status and Registrants' Response Forms
(Form B) plus Instructions
Attachment D - List of all Registrant(s) sent this DCI
Appendix G - Product Specific Data Call-In
Attachment A - Chemical Status Sheet
Attachment B - Product Specific DCI Response Forms (Form A) plus
Instructions
Attachment C - Requirements Status and Registrants' Response Forms
(Form B) plus Instructions
Attachment D - EPA Grouping of End Use Products for meeting Acute
Toxicology Data Requirements.
Attachment E - EPA Acceptance Criteria
Attachment F - List of all Registrant(s) sent this DCI
Attachment G - Cost Share/Data Compensation Forms
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WOOD OILS AND GUMS REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Bioloeical and Economic Analysis Division
Janet Andersen
Environmental Fate and Effects Division
William Schneider
Health Effects Division
Flora Chow
Tom McCUntock
Charles Prick
Registration Division
Marion Johnson, Jr.
Al Smith
JoAnne Hayes
Special Review and Reregistration Division
Virginia Dietrich
Brace Sidwell
Biological Analysis Branch
Science Analysis and Coordination Staff
Chemical Coordination Branch
Science Analysis Branch
Chemical Coordination Branch
Insecticide and Rodenticide Branch
Registration Support Branch
Registration Support Branch
Accelerated Reregistration Branch
Accelerated Reregistration Branch
Office of Compliance Monitoring:
Phyllis Flaherty
Pesticides Enforcement Policy Branch
Office of Genera] Counsel:
Kevin Lee
Pesticides Branch
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GLOSSARY OF TERMS AND ABBREVIATIONS
a,i. Active Ingredient
CAS Chemical Abstracts Service
CSF Confidential Statement of Formula
EEC Estimated Environmental Concentration. The estimated pesticide concentration
in an environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FLFKA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
HDT Highest Dose Tested
LC50 Median Lethal Concentration. A statistically derived concentration of a substance
that can be expected to cause death in 50% of test animals. It is usually
expressed as the weight of substance per weight or volume of water or feed, e.g.,
mg/1 or ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to
cause death in 50% of the test animals when administered by the route indicated
(oral, dermal). It is expressed as a weight of substance per unit weight of animal,
e.g., mg/kg.
LD10 Lethal Dose-low. Lowest Dose at which lethality occurs
LEL Lowest Effect Level
LOEL Lowest Observed Effect Level
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of recording and tracking
studies submitted.
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GLOSSARY OF TERMS AND ABBREVIATIONS (cont.)
N/A Not Applicable
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
ppm Parts Per Million
RfD Reference Dose
RS Registration Standard
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TC Toxic Concentration. The dose at which a substance produces a toxic effect.
TMRC Theoretical Maximum Residue Contribution.
IV
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EXECUTIVE SUMMARY
The Agency has completed its reregistration assessment of the available information on
the pesticide active ingredient cedarwood oil in the case named Wood Oils and Gums. It has
been determined that the currently registered uses will not cause unreasonable risk to humans
or the environment and these uses are eligible for reregistration.
Cedarwood oil is a natural component of wood from the tree, Juniperus virginiana L.,
for use in pesticide products to repel moths from and inhibit mildew in clothing; and repel fleas
from pets and their sleeping quarters. Current registered products include cedarwood blocks,
a pet collar, and a ready-to-use liquid. The Agency is proposing, under a separate action, to
deregulate the cedarwood block products in accordance with FIFRA 25(b).
Before reregistering the products containing cedarwood oil, the Agency is requiring that
additional technical chemistry data on the extracted oil, as well as product specific data on acute
toxicology, chemistry and efficacy, revised Confidential Statements of Formula (CSF) and
revised labeling be submitted within eight months of the issuance of this document. After
reviewing these data and revised labels and finding them acceptable in accordance with Section
3(c)(5) of FIFRA, the Agency will reregister products. 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.
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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 U.S. Environmental Protection Agency (referred to as "the Agency") of all
data submitted to support reregistration.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine whether
pesticides containing such active ingredient are eligible for reregistration" before calling in data
on products and either reregistering products or taking other "appropriate regulatory action."
Thus, reregistration involves a thorough review of the scientific data base underlying a
pesticide's registration. The purpose of the Agency's review is to reassess the potential hazards
arising from the currently registered uses of the pesticide; to determine the need for additional
data on health and environmental effects; and to determine whether the pesticide meets the "no
unreasonable adverse effects" criterion of FIFRA.
This document presents the Agency's decision regarding the reregistration eligibility of the
registered uses of cedarwood oil. The document consists of six sections. Section I is the
introduction. Section n describes cedarwood oil, its uses, data requirements and regulatory
history. Section in discusses the human health and environmental assessment based on the data
available to the Agency. Section IV presents the reregistration decision for cedarwood oil.
Section V discusses the reregistration requirements for cedarwood oil . Finally, Section VI is
the Appendices which support this Reregistration Eligibility Decision document. Additional
details concerning the Agency's review of applicable data are available on request.1
JEPA's reviews of data on the set of registered uses considered for EPA's analysis may be
obtained from the OPP Public Docket, Field Operations Division (H7506C), Office of Pesticide
Programs, EPA, Washington, DC 20460.
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CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility
Decision document:
* Common Name: Cedarwood oil
Chemical Name: Oil extracted from species of cedar trees, especially
Juniperos viiginiana L. (1)
* Chemical Family: Wood oils and gums
» CAS Registry Number: 800-27-9
* OPP Chemical Code: 40505
Empirical Formula: cedarwood oil is a mixture of organic
compounds
• Trade and Other Names: oil of cedar
• Basic Manufacturer: not applicable
B. Use Profile
The following is information on the current registered uses with an overview of
use sites and application methods. Appendix A is a detailed table of these uses of
cedarwood oil.
For Cedarwood oil:
Type of Pesticide: repellant/feeding depressant; fungicide
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Use Sites: Indoor Residential - domestic dwellings and their contents,
Pets/Animals (presumably cats and dogs) and their Eving and sleeping
quarters
Target Pests: fleas, moths, mildew
Formulation Types Registered:
Liquid ready-to-use - sprayed on animal bedding
0.48 % cedarwood oil
Impregnated pet collar/tag
0.5 % oil of citronella
1.0 % oil of eucalyptus
0.5 % cedarwood oil
2.0 % oil of pennyroyal
0.125 % oils, rue;
Wood blocks, containing an average of —
5.17% cedarwood oil (2-8% range)
C. Data Requirements
The Agency has waived all generic data requirements except for physical
chemistry for this active ingredient. The rationale for this action is discussed below and
also in Section HE. Instead it has relied on general, commonly available information
about cedarwood oil. Appendix B includes all data requirements identified by the
Agency for currently registered uses needed to support reregistration.
EPA has developed a target database, set forth in the regulations (2) and the
Agency's Reregistration Phase 2 Technical Guidance Document, to be addressed for
pesticide reregistration. These regulations and the Guidance Document specify the
necessary data based on factors including use sites, potential environmental and human
(dietary and occupational) exposures, product formulation types, and product application
methods. Due to 4he-diverse~nature and characteristics of pesticide products and their
uses subject to reregistration, the Agency also recognizes the necessity to modify the data
requirements for specific pesticides, including waiving certain data requirements because
such requirements are inappropriate or unnecessary for risk assessment and reregistration.
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This approach to waiving individual data requirements has served to identify the
appropriate data requirement sets for pesticide products. Further, the Agency believes
there is a category of pesticide active ingredients for which a broadly reduced set of data
requirements are appropriate for reregistration. Specifically, products in this category
may be exempt from the generic data requirements for toxicology, residue chemistry,
human exposure, ecological effects, and environmental fate on the active ingredient. The
Agency believes there are considerations which, when taken together, can form the basis
for a conclusion that such a reduction in data requirements is appropriate for a particular
pesticide active ingredient, .while not compromising human health or environmental
safety.
There are, however, certain data requirements which are essential and not likely
to be waived. Basic product identity/chemistry information on the active ingredient and
formulated products is required for pesticides in this category so that the Agency has
reasonable certainty of the pesticide's chemical and physical characteristics. Also,
product specific acute toxicology studies are required for the Agency to determine
appropriate product labeling for potential hazards to those who handle or apply these
products. However, these toxicology studies may also be waived if an assessment of the
product formulation, including the inert ingredients, indicates that such studies are
unnecessary to prescribe appropriate labeling. Efficacy studies may be required of
formulated products labeled for uses and pests that are of a public health concern.
In considering cedarwood oil for reregistration eligibility the Agency believes it
is an active ingredient that should be considered for this broad waiver of the generic data
requirements. The considerations that led the Agency to this conclusion are discussed in
Section in below.
D. Regulatory History
Originally, the reregistration case Wood Oil and Gums included three active
ingredients; cedarwood oil, Canadian balsam, and ester gum. After Phase 2 in 1990,
products containing the latter two active ingredients were cancelled for non-support by
the registrants, leaving only products containing cedarwood oil.
Cedarwood oil was initially registered as a pesticide in the United States in 1960
to repel moths from clothing. Since then products have been registered to repel fleas
from pets and their bedding. The five currently registered products containing
cedarwood oU as-art-active-ingredient fall under one of three types of pesticide products:
three are solid cedarwood block products, ("Cedar Fresh", EPA Reg. No. 65555-1;
"Ozark Cedar", EPA Reg. No. 65813-1, and "Woodland/RPM Cedar", EPA Reg. No.
66211-1), one product is a pet collar ("Herbal Flea Collar", EPA Reg. No. 42443-1),
and one product is a ready-to-use liquid that may be applied by hand spray ("Green Earth
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Flea Spray" Reg. No. 63380-1).
ffl. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
Cedarwood oil is a distilled extract from the cured cedarwood obtained from
Juniperus virginiana L., and other species of cedar. The chief chemical components are
cedrene (a terpene) and cedral (cedar camphor).
Cedarwood oil ranges in color from colorless to slightly yellow. It is somewhat
viscid. It is insoluble in water but soluble in both alcohol and ether (1).
B. Human Health And Environmental Assessment
As discussed above, the Agency has waived the generic data requirements, except
for certain technical chemistry information, for cedarwood oil. It is relying on
commonly available information about this chemical and its uses to reach a decision
about its potential risks to human health and the environment associated with the current
uses of registered products. The specific information about cedarwood oil the Agency
considered is as follows:
Cedarwood oil is a mixture of organic compounds. It is a component of many
non-pesticidal consumer products currently marketed in the United States. Cedarwood
oil is listed as a food additive by the Food and Drag Administration (5). The alcohols
and terpenes of cedarwood oil are considered by FDA to be Generally Recognized As
Safe (GRAS). As a pesticide, it repels insect pests by a non-toxic mode of action. Its
mode of action against mildew is unknown. EPA is not aware of any adverse effects of
the active ingredient to humans or the environment in the literature when used in a
manner prescribed in end-use product labeling. There have been no reported incidents
of toxicity.
There have been some studies performed on cedarwood dust as well as the
constituents of cedarwood oil. According to a recent survey of the literature, pulmonary
effects and liver effects have been noted in laboratory animals (3). These effects are
hypothesized to be related to the occupational hazards associated with saw mill workers
(4) chronically exposed-te-environments high in cedarwood dust. However, this type of
exposure is not indicative of that from use of the currently registered pesticide products.
The Agency believes there is negligible human and environmental exposure to the
pesticide as a result of the use patterns; there is a low use rate and frequency of
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application and/or the products are applied in a confined or contained manner. However,
the handling and use of the liquid product could pose a relatively greater exposure
potential by the dermal and inhalation routes. Product specific acute toxicity testing will
allow the Agency to address appropriate labeling to address potential concerns for users.
Since the pesticide will be used in indoor domestic dwellings, on pets and on their
living and sleeping quarters, the Agency expects that there will be negligible exposure
to the environment and to nontarget organisms.
Based on these factors the Agency does not believe generic data, beyond those
data required to satisfy basic characterization of the chemistry (refer to Appendix B), are
necessary to determine whether the current registered uses of this active ingredient pose
unreasonable risks to humans or the environment. However, it is requiring the
submission of product specific data (chemistry, acute toxicity and efficacy).
In conclusion, the Agency has determined that the use of cedarwood oil as an
active ingredient in products for the current uses should not result in unreasonable
adverse effects to human health or the environment.
IV. RISK MANAGEMENT AND REREGISTRATIQN ELIGIBILITY DECISION
A. Determination of Reregistration 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. As discussed above, the Agency has
determined that the set of generic data requirements that would normally be applicable
to cedarwood oil need not be satisfied for the Agency to reach a decision on potential
risks and reregistration eligibility. Rather, it has considered general and commonly
available information. The Agency has determined that cedarwood oil meets .criteria as
outlined in the document "Guidance for Making Determinations to Reduce Data
Requirements". Cedarwood oil met the criteria due to its use and availability for non-
pesticide food uses, its regulatory status as a chemical classified as GRAS and exempt
from the requirement of food additive tolerances; its non-toxic mode of action as a
pesticide; that there is negligible human and environmental exposure to the pesticide as
a result of the porposed use pattern, and the lack of reports of adverse effects. (No data
were submitted-u«der-6(a)(2)"Of FIFRA, no significant incidents have been reported to
the Agency, and there is no indication in the literature that the pesticide poses adverse
effects in humans or to the environment when used in a manner prescribed in end-use
poduct labeling.) Appendix B identifies the sources for this information that the Agency
reviewed as part of its determination of reregistration eligibility of cedarwood oil and
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lists the submitted studies that the Agency considered acceptable.
The Agency believes this information is sufficient to support reregistration and,
that cedarwood oil can be used without resulting in unreasonable adverse effects to
human health and the environment. The Agency therefore finds that all products
containing cedarwood oil as the active ingredient are eligible for reregistration. The
reregistration of particular products is addressed in Section V of this document.
Although the Agency has found that all uses of cedarwood oil 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 cedarwood oil, if new information comes to the Agency's attention
or if the data requirements for registration (or the guidelines for generating such data)
change.
However, the Agency has determined that natural cedarwood products consisting
of wood blocks, not treated or impregnated with any additional substance(s), distributed
and sold as moth and flea repellents or mildew control agents, are of a character which
is unnecessary to be subject to FEFRA. Cedarwood oil is naturally contained in the cedar
wood; it cannot easily be separated from the wood or wood products. Consumers using
these cedarwood products are unlikely to be exposed to significant amounts of cedarwood
dust or oil, either by the inhalation or dermal route. The Agency believes there is
negligible risk to man or the environment associated with the use of these wood products
as pesticides. Therefore, under authority of FXFRA section 25(b), 7 U.S.C 136w(b), the
Agency has proposed that such products be exempted from provisions of FIFRA, except
misbranding provisions (58 FR 42711; August 11, 1993). A 30-day comment period is
provided. Products containing cedarwood oil extracted from wood or synthesized and
subsequently used for pesticide purposes are not included in this proposed exemption.
Since the Agency is proposing that these cedarwood products be exempted from
regulation, further reregistration requirements are being held in abeyance. If the Agency
concludes it should not proceed to effect the exemption of these products, the Agency
will proceed to impose the appropriate reregistration requirements on these products.
1. Eligible and Ineligible Uses
The Agency has determined that all current uses of cedarwood oil products
are eligible for reregistration.
B. Risk Management Decision
In consideration of the above information about cedarwood oil, the Agency finds
no reason to impose new risk reduction measures for currently registered uses. The
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Agency will however, assess the need for product specific risk reduction measures upon
receipt of data that are being required under the Product Specific Data Call-in Notice
appended to this document.
V. ACTIONS REQUIRED BY REGISTRANTS
This section specifies the data requirements and responses necessary for thereregistration
of end-use products. Because there are no registered manufacturing-use products or technical
products the generic data requirements are required for all registrants.
A. Technical Grade Information
1. Generic Data Requirements
There are currently no registered manufacturing use products for
cedarwood oil. The generic data base supporting the reregistration of products
containing cedarwood oil for the above eligible uses has been reviewed and
determined to be incomplete. Registrants are required to submit the technical
chemistry data corresponding to Series 61 and Series 62 for the analysis and
certification of product ingredients. If the product is a United Stales
Pharmacopoeia (USP) grade, a copy of USP analysis with citation of the
analytical methods used and certification would satisfy the requirement for Series
62.
The Confidential Statement of Formula (CSF) must be supported by
analytical data. The data on the physical and chemical characteristics of
cedarwood oil from the Material Safety Data Sheet (MSDS) for the product may
be compiled by the registrant in the format required by the FIFRA Accelerated
Reregistration Phase 3 Technical Guidedance, specifically PR Notice 86-5 to
satisfy some of the requirements of Series 63. The generic data requirements are
listed in Appendix F, the Generic Data Call-in Notice.
B. End-Use Products
1. Additional Product-Specific Data Requirements
-Section 4(g)(2)B) of FDFRA 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.
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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.
Additional physical chemistry data on cedarwood oil are required to
provide the Agency with a more complete characterization of the chemistry of the
cedarwood oil that is used in the registered products. These generic data
requirements are imposed on the end-use products because there is no registered
source of technical grade cedarwood oil.
2. Labeling Requirements for End-Use Products
The labels and labeling of all products must comply with EPA's current
regulations and requirements as specified in 40 CFR §156.10. Please follow the
instructions in the Pesticide Reregistration Handbook with respect to labels and
labeling. In addition, registrants with products that are used on pets and/or
animals will be required to specify on their labels which animals may be treated
with the product.
A. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling
for 26 months from the date of the issuance of this Reregistration Eligibility Decision
document (RED). Persons other than the registrant may generally distribute or sell such
products for 50 months from the date of the issuance of the 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 cedarwood oil
products bearing old labels/labeling for 26 months from the date of issuance of this RED.
Persons other than the registrant may distribute or sell such products for 50 months from
the date of the issuance of this RED.
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VI.
APPENDICES
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12
•>.!*>*
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APPENDIX A
Table of Use Patterns Subject to Reregistration
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Date 09/15/91 - Time 15:39
APPENDIX A - CASE 3150, Wood oil* Mid guw! Ote»tcal 040505 ICedartwod oil]
SITE Application Type, Application
lining. Application Equipment -
Surface Type 1 Efficacy Influen-
cing Factor (AntlMlcroelal only)
USES ELIGIBLE FOR REREGI STRATI ON
NOK- FOOD /HOK- FEED
Fora Minimum
Application
Rate
Maxima
Application
Ratea
Sol I Max
Text •
(Max Appa
Oae)
Max.
*PP«
• Max
Rate
Mln.
Inter*
Cdaya)
Reetr. Geographic Geographic
Entry At toned Dl tallowed
Interv
: INDOOR RESIDENTIAL
NA * NS NS AN
NA * NS NS US
Uae 6r«4»: INDOOR RESIDENTIAL
NA * MS NS AN
.0003125 Ib *
enl«al
NS
NS
NS
NS
NS
NS
NS
IS
•s
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Oete 09/15/9! - T(M 15:39 APPENDIX A - CASE 3150, [Wood oUt am* gum] etwBieal 0*0505 ICedartMOd *ll| Pea* 2
LEGEND
HEAD6*. ABBREVIATIONS
Max. i App* i Nax1«M ranter of Application*
MM. ApjM • Nan Rat* t NaxfmM nuiter of Applications at Maxfiue Do*ag* Rate
Nfn. Interv (day*) : NinfauR Interval between Applications (day*)
Reatr. Entry Interv (days) : Rettrlcted Entry Interval (days)
SOI| TptWt FCH KAX APP. HATE
*i Non*apeeiflc
C i Coartt
N t Nedlua
F i Fin*
0 : Other*
FOKWLATJON COOES
IC/T ! IMPREGNATED COLLAR/TAG
IMPU : IMPREGNATED MATERIAL
R1U ! LIOU1D-REAOT TO USi
AMBEVIAT10HS
AS: At Natdtd
HA i Not Applicable
NS : Hot Specified (on label)
ICAT!CM KATE
Dosage Can Hot be Calculated
No CaLc : No Calculation can be Mde
V : PfN calculated by Height
V i PM Calculated by voluM
cut i Hundred Weight
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APPENDIX B
Table of the Generic Data Requirements and
Studies Used to Make the Reregistration Decision
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GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for
the pesticide bromine covered by this Reregistration Eligibility Decision. It contains generic data
requirements that apply to bromine 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 die 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
MR£D -number has been assigned. Refer to the Bibliography appendix for a
complete citation of the study.
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APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Cedarwood Oil
REQUIREMENT
USE PATTERN CITATION
PRODUCT CHEMISTRY
61-1 Chemical Identity
61-2A Start. Mat. & Mnfg. Process
61-2B Formation of Impurities
62-1 Preliminary Analysis
62-2 Certification of limits
62-3 Analytical Method
63-2 Color
63-3 Physical State
63-4 Odor
63-5 Melting Point
63-6 Boiling Point
63-7 Density
63-8 Solubility
63-9 Vapor Pressure
63-10 Dissociation Constant
63-11 Octanol/VVater Partition
63-12 pH
All 42319001,42101201,41549503
All 42101201, 42362601, 42319001
All 42101201,42362601,42319001
AH 42362602,42319002
All 42362602,42319002
All 42319002
All SATISFIED
All SATISFIED
All SATISFIED
AU SATISFIED
All SATISFIED
All SATISFIED
AU SATISFIED
All SATISFIED
ALL SATISFIED
ALL SATISFIED
ALL SATISFIED
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APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Cedarwood Oil
REQUIREMENT
PRODUCT CHEMISTRY
63-13' Stability
71-1A Acute Avian Oral - Quail/Duck
71-2A Avian Dietary - Quail
72-1 A Fish Toxicity Bluegill
72-1 C Fish Toxicity Rainbow Trout
72-2A Invertebrate Toxicity
TOXICOLOGY
81-1 Acute Oral Toxicity - Rat
81-2 Acute Dermal Toxicity -
Rabbit/Rat
81-3 Acute Inhalation Toxicity - Rat
81-4 Primary Eye Irritation - Rabbit
81-5 Primary Dermal Irritation -
USE PATTERN
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
CITATION
SATISFIED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
Rabbit
81-4 Dermal Sensitization - Guinea
Pig
ALL
WAIVED
Confirmatory data are being required from certain registrants
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APPENDIX B
__ Datsf Supporting Guideline Requirements for the Reregistration of Cedarwood Oil
REQUIREMENT , USE PATTERN CITATION
TOXICOLOGY
84-2A Gene Muatation-(Ames Test) All WAIVED
84-2B Structural Chromosomal ALL WAIVED
Aberration
84-4 Other Genotoxic Effects ALL WAIVED
22
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APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Cedarwood Oil
REQUIREMENT
USE PATTERN CITATION
Hydrolysis
ALL
WAIVED
23
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f
24
TV.
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I
APPENDIX C
Citations Considered to be Part of the Data Base
Supporting the Reregistration of Wood Oils and Gums
25
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I
26
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GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY, This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere
in the ^registration Eligibility Decision. Primary sources for studies in this
bibliography have been the body of data submitted to EPA and its predecessor agencies
in support of past regulatory decisions. Selections from other sources including the
published literature, in those instances where they have been considered, are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the
case of published materials, this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency has sought to identify
documents at a level parallel to the published article from within the typically larger
volumes in which they were submitted. The resulting "studies" generally nave a distinct
title (or at least a single subject), can stand alone for purposes of review and can be
described with a conventional bibliographic citation. The Agency has also attempted to
unite basic documents and commentaries upon them, treating them as a single study.
3, IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID number". This number is unique
to the citation, and should be used whenever a specific reference is required. It is not
related to the six-digit "Accession Number" which has been used to identify volumes of
submitted studies (see paragraph 4(d)(4) below for further explanation). In a few cases,
entries added to the bibliography late in the review may be preceded by a nine character
temporary identifier. These entries are listed after all MRID entries. This temporary
identifying number is also to be used whenever specific reference is needed.
4, FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the
Agency has shown an identifiable laboratory or testing facility as the author.
When no author or laboratory could be identified, the Agency has shown the first
submitter as the author.
b. Document date. The date of the study is taken directly from the document.
When the date is followed by a question mark, the bibliographer has deduced the
date from the evidence contained in the document. When the date appears as
(19??), the Agency was unable to determine or estimate the date of the document.
27
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i
c. Title. In some cases, it has been necessary for the Agency bibliographers to
create or enhance a document title. Any such editorial insertions are contained
between square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing
parentheses include (in addition to any self-explanatory text) the following
elements describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the
word "under" is the registration number, experimental use permit number,
petition number, or other administrative number associated with the
earliest known submission.
(3) Submitter. The third element is the submitter. When authorship is
defaulted to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume in
which the original submission of the study appears. The six-digit
accession number follows the symbol "CDL," which stands for "Company
Data Library." This accession number is in turn followed by an
alphabetic suffix which shows the relative position of the study within the
volume.
28
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41549503
42101201
42319001
42319002
42362601
42362602
1. The Merck Index; An Encyclopedia of Chemicals, Drugs, and Biologicals.
Windholz, Martha, editor, et. al. Tenth Edition. Published in 1983 by Merck
and Company, Rahway New Jersey, U.S.A.
2. Code of Federal Regulations, Title 40, part 158, revised as of My 1, 1992.
Published by the Office of the Federal Register National Archives and Records
Administration, Washington, D.C., U.S.A.
3. Gordon WP; Forte AJ; McMurtry RJ; Nelson SD (1982) Hepatotoxicity and
Pulmonary Toxicity of Pennyroyal Oil and its Constituent Terpenes in the Mouse.
Published by the Journal of Toxicology and Applied Pharmacology; Volume 65,
ISS 4, P413-24.}
4. Ayars GH; Altman LC; Frazier CE; CM BY; (1989) The Toxicity of
Constituents of Cedar and Pine Woods to Pulmonary Epithelium. Published by
Journal of Allergy and Clinical Immunology; Volume 83, ISS 3, P610.
5. Code of Federal Regulations, Title 21, part 172, section 515, revised as of
July 1, 1992. Published by the Office of the Federal Register National Archives
and Records Administration, Washington, D.C., U.S.A.
Gunther (19??) Oil of Cedarwood. pp. 356-363 in unknown source.
Arbor American Corp. (1991) Chemical Identity: Cedar Wood Oil. Unpublished
study. 6 p.
Anon. (1992) Product Identification and Disclosure of Ingredients; Description
of Beginning Materials and Manufacturing process; Discussion of formation of
impurities (contains published material). Unpublished study prepared by Cor-Pak
International. 15 p,
Maltese, L. (1992) Analysis of Redwood Cedars: Lab Project Number: 92-1076:
92-1117: 92-1216. Unpublished study prepared by Stillwell & Gladding. 13 p.
Anon, (1992) Description of Materials Used to Produce Product and Description
of Production Process: Aromatic Cedar. Unpublished study prepared by P & M
-Consumer Products, Inc. 7 p.
Zavarin, E. (1992) Analysis of Red Cedar Wood Juniperus Virginiana:
Unpublished study prepared by Forest Products Laboratory (University of
California at Berkley). 8 p.
29
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i
30
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i
APPENDIX D
List of Available Related Documents
31
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32
:•<*»
r
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The following is a list of available documents related to cedarwood oil. It's puipose is
to provide a path to more detailed information if it is needed. These accompanying documents
are part of the Administrative Record for cedarwood oil 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. Cedarwood oil RED Fact Sheet
4. PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient
Statement
5. Guidance for Making Determinations to Reduce Data Requirements
6. Minutes from the April 19 and May 17 meetings of the Ad Hoc Screening
Committee for Reduced Data Requirements
33
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i
34
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i
APPENDIX E
Pesticide Reregistration Handbook
PR Notices 86-5 and 91-2
35
53?
y \.
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36
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i
PESTICIDE REGISTRATION HANDBOOK
37
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38
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PR Notice 86-5
39
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40
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
July 29, 1986
OFFICE OF
PR NOTICE 86-5 PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
NOTICE TO PRODUCERS, FORMULATORS, DISTRIBUTORS
AND REGISTRANTS
Attention: Persons responsible for Federal registration of
pesticides.
Subject: Standard format for data submitted under the
Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) and certain provisions of the Federal
Food, Drug, and Cosmetic Act (FFDCA),
I. Purpose
To require data to be submitted to the Environmental
Protection Agency (EPA) in a standard format. This Notice also
provides additional guidance about, and illustrations of, the
required formats.
II. Applicability
This PR Notice applies to all data that are submitted to EPA
to satisfy data requirements for granting or maintaining
pesticide registrations, experimental use permits, tolerances,
and related approvals under certain provisions of FIFRA and
FFDCA. These data are defined in FIFRA §10(d){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
This notice is effective on November 1, 1986. Data formatted
according to this notice may be submitted prior to the effective
date. As of the effective date, submitted data packages that do
not conform to these requirements may be returned to the
submitter for necessary revision.
IV. Background
On September 26, 1984, EPA published proposed regulations in
the Federal Register (49 FR 37956) which include Requirements for
Data Submission (40 CFR §158.32), and Procedures for Claims of
Confidentiality of Data (40 CFR §158.33). These regulations
41
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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
entire proposed regulation becomes final. Adequate lead time is
being provided for submitters to comply with the new
requirements.
V. Relationship ofthis Notice to Other OPP Policy and Guidancg
While this Notice contains requirements for organizing and
formatting submittals of supporting data, it does not address the
substance of test reports themselves. "Data reporting" guidance
is now under development in OPP, and will specify how the study
objectives, protocol, observations, findings, and conclusions are
organized and presented within the study report. The data
reporting guidance will be compatible with submittal format
requirements described in this Notice.
OPP has also promulgated a policy (PR Notice 86-4 dated
April 15, 1986) that provides for early screening of certain
applications for registration under FIFRA §3. The objective of
the screen is to avoid the additional costs and prolonged delays
associated with handling significantly incomplete application
packages. As of the effective date of this Notice, the screen
will include in its criteria for acceptance of application
packages the data formatting requirements described herein.
OPP has also established a public docket which imposes
deadlines for inserting into the docket documents submitted in
connection with Special Reviews and Registration Standards (see
40 CFR §154.15 and §155.32). To meet these deadlines, OPP is
requiring an additional copy of any data submitted to the docket.
Please refer to Page 10 for more information about this
requirement.
For several years, OPP has required that each-application.
for registration or other action include a list of all applicable
data requirements and an indication of how each is satisfied--the
statement of the method of support for the application.
Typically, many requirements are satisfied by reference to data
previously submitted--either by the applicant or by another
party. That requirement is not altered by this notice, which
applies only to data submitted with an application.
¥1. Forma.t Requirements
A more detailed discussion of these format requirements
follows the index on the next page, and samples of some of the
requirements are attached. Except for the language of the two
alternative forms of the Statement of Data Confidentiality Claims
(shown in Attachment 3) which cannot be altered, these samples
are illustrative. As long as the required information is
included and clearly identifiable, the form of the samples may be
altered to reflect the .submitter's preference.
42
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i
- INDEX-
Text Example
Page Page
A. Organization of the Submittal Package 3 17
B. Transmittal Document 4 11
C. Individual Studies . ..... 4
C. 1 Special Considerations for Identifying Studies . . 5
D. Organization of each Study Volume . 6 17
D. l .Study Title Page 7 12
D. 2 Statement of Data Confidentiality Claims
{based on FIFRA §iO(d)(D) ........ 8 13
D. 3 Confidential Attachment . 8 15
D. 4 Supplemental Statement of Data Confidentiality
Claims {other than those based on FIFRA §10{d){lJ) 8 14
D. 5 Good Laboratory Practice Compliance Statement . . 9 16
E. Reference to Previously Submitted Data 9
F. Physical Format Requirements & Number of Copies .... 9
G. Special Requirements for Submitting Data to the Docket 10
**************
A. Organization of Submittal Package
A "submittal package" consists of all studies submitted at
the same time for review in support of a single regulatory
action, along with a transrnittal document and other related
administrative material (e.g. the method of support statement,
EPA Forms 8570-1, 8570-4, 8570-20, etc.) as appropriate.
Data submitters must organize each submittal package as
described in this Notice. The transmittal and any other admin-
istrative material must be 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).
43
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B» Transmittal
The first item in each submittal package must be a trans-
mittal document. This document identifies the submitter or all
joint submitters; the regulatory action in support of which the
package is being submitted--i.e., a registration application,
petition, experimental use permit (EUP), §3(c)(2)(B) data
call-in, §6(a)(2) submittal, or a special review; the transmittal
date; and a list of all individual studies included in the
package in the order of their appearance, showing (usually by
Guideline reference number) the data requirement(s) addressed by
each one. The EPA-assigned number for the regulatory action
(e.g. the registration, EUP, or tolerance petition number) should
be included in the transmittal document as well, if it is known
to the submitter. See Attachment 1 for an example of an
acceptable transmittal document.
The list of included studies in the transmittal of a data
submittal package supporting a registration application should be
subdivided by discipline, reflecting the order in which data
requirements appear in 40 CFR 158.
The list of included studies in the transmittal of a data
submittal package supporting a petition for tolerance or an
application for an EUP should be subdivided into sections A, B,
C,.... of the petition or application, as defined in 40 CFR 180.7
and 158.125, (petitions) or Pesticide Assessment Guidelines,
Subdivision I (EUPs) as appropriate.
When a submittal package supports a tolerance petition and
an application for a 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 some 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 l. 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.
44
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When a single study is extremely long, binding it in mul-
tiple volumes is permissible so long as the entire study is pag-
inated in a single series, and each volume is plainly identified
by the study title and its position in the multi-volume sequence.
C.I gpecial 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 ChemistryStudies. All product chemistry data
within a submittal package submitted in support of an end-use
product produced from registered manufacturing-use products
should be bound as a single study under a single title page.
Product chemistry data submitted in support of a technical
product, other manufacturing-use product, an experimental use
permit, an import tolerance petition, or an end-use product
produced from unregistered source ingredients, should be bound as
a single study for each Guideline series {61, 62, and 63) for
conventional pesticides, or for the equivalent subject range for
biorational pesticides. The first of the three studies in a.
complete product chemistry submittal for a biochemical pesticide
would cover Guidelines 151-10, 151-11, and 151-12; the second
would cover Guidelines 151-13, 151-15, and 151-16,- the third
would cover Guideline 151-17. The first study for a microbial
pesticide would cover Guidelines 151-20, 151-21, and 151-22; the
second would cover Guidelines 151-23 and 151-25; the third would
cover Guideline 151-26.
Note particularly that product chemistry studies are likely
to contain-Confidential-Business Information as defined in FIFRA
§10(d)(l)(A), (B) , or {C5, and if so must be handled as described
in section D.3. of this notice.
45
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c. Residue ChemistryStudies. Guidelines 171-4, 153-3,
and 153-4 are extremely broad in scope; studies addressing
residue chemistry requirements must thus be defined at a level
below that of the Guideline code. The general principle,
however, of limiting a study to the report of a single 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
Each complete study must include all applicable elements in
the list below, in the order indicated. (Also see Page 17.)
Several of these elements are further explained in the following
paragraphs. Entries in the column headed "example" cite the
page number of this notice where the element is illustrated.
Element
Study Title Page
Statement of Data
Conf ident iali ty
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 toxicology studies (When
flagging requirements are finalized.)
Always - with an English language
•translation if required,
At submitter's option
If CBI is claimed under FIFRA
§10 (d) (1) (A) , (B), or (C)
CBI Attachment
Supplemental Statement
of Data Confidentiality
Claims
If CBI is claimed under FIFRA
510(d)(l)(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)
46
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D.l. Title Page
A title page is always required for each submitted study,
published or unpublished. The title page must always be freely
releasable to requestors; DO NOT INCLUDE CBI ON THE TITLE PAGE.
An example of an acceptable title page is on page 12 of this
notice. The following information must appear on the title page:
a. Study title. The study title should be as descriptive as
possible It must clearly identify the substance(s) tested and
correspond to the name of the data requirement as it appears in
the Guidelines.
b. Data requirement addressed. Include on the title page the
Guideline number(s) of the specific requirement(s) addressed by
the study.
c. Author(s). Cite only individuals with primary intellectual
responsibility for the content of the study. Identify them
plainly as authors, to distinguish them from the performing
laboratory, study sponsor, or other names that may also appear on
the title page.
d. Study Date. The title page must include a single date for
the study. If parts of the study were performed at different
times, use only the date of the latest element in the study.
e. Performing Laboratory Identification. If the study reports
work done by one or more laboratories, include on the title page
the name and address of the performing laboratory or
laboratories, and the laboratory's internal project number(s) for
the work. Clearly distinguish the laboratory's project
identifier from any other reference numbers provided by the study
sponsor or submitter.
f. Supplemental Submissions. If the study is a commentary on
or supplement to another previously submitted study, or 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).
g. Facts of Publication. If the study is a reprint of a pub-
lished document, identity on the title page all relevant facts of
publication, such as the journal title, volume, issue, inclusive
page numbers, .and publication date.
47
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D.2. Statements of Data Confidentiality Claims Under FIFRA
§10(d)(1).
Each submitted study must be accompanied by one of the two
alternative forms of the statement of Data Confidentiality Claims
specified in the proposed regulation in §158.33 (b) and (c) (See
Attachment 3). These statements apply only to claims of data
confidentiality based on FIFRA §10(d)(1)(A), (B3 , or (C). Use
the appropriate alternative form of the statement either to
assert a claim of §10(d)(l) data confidentiality (§158.33(b)) or
to waive such a claim (§158.33(c)). In either case, the
statement must be signed and dated, and must include the typed
name and title of the official who signs it. Do not make CBI
claims with respect to analytical methods associated with pet-
itions for tolerances or emergency exemptions (see NOTE Pg 13).
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 information to which the claim applies must
be clearly marked in the body of the study as subject to a
claim of confidentiality.
- A Supplemental Statement of 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.
48
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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 STUD? THAT HAS PREVIOUSLY BEEN SUBMITTED
FOR ANOTHER PURPOSE unless EPA specifically requests it. A copy
of the title page plus the MRID number (if known) is sufficient
to allow us to retrieve the study immediately for review. This
prevents duplicate entries in the Agency files, and saves you
the cost of sending more copies of the study. References to 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
instructions before submitting data in any medium other than
paper, such as film or magnetic media.
Please be particularly attentive to the following points:
» Do not include frayed or torn pages.
• Do not include carbon copies, or copies in other than
black ink.
» Make sure that photocopies are clear, complete, and
fully readable.
» Do not include oversize computer printouts or fold-out
pages.
» Do not bind any documents with glue or binding tapes.
• Make sure that all pages of each study, including any
attachments or appendices, are present and in correct
sequence.
Number of Copies Required - All submittal packages except
those associated with a Registration Standard or Special Review
(See Part G -below} must be provided In three complete, identical
copies. (The proposed regulations specified two copies; three
are now being required to expedite and reduce the cost of
processing data into the OPP Pesticide Document Management System
and getting it into review.}
49
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I
G.
:ina Data to the Docket
Data submittal packages associated with a Registration Stan-
dard or Special Review must be provided in four copies, from one
of which all material claimed as CBI has been excised. This
fourth copy will become part of the public docket for the RS or
SR case. If no claims of confidentiality are made for the study,
the fourth copy should be identical to the other three. When
portions of a study submitted in support 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)(l)(A), (B), or (C). Do not
close up or paraphrase text remaining after this
excision.
» Mark the fourth copy plainly on both its cover and its
title page with the phrase "Public Docket Material -
contains no information claimed as confidential".
V.
For Further Information
For further information contact John Carley, .Chief,
Information Services Branch, Program Management and Support
Division, (703) 305-5240.
/">
fttmi99 V. Ak*rman
/ActIns Oirtctor.
^ «Bgiatr*tlor> Division
Attachment 1. Sample Transmittal Document
Attachment 2... -Sample Title Page for a Newly Submitted Study
Attachment 3. Statements of Data Confidentiality Claims
Attachment 4. Supplemental Statement of Data Confidentiality
Claims
Attachment 5. Samples of Confidential Attachments
Attachment 6. Sample Good Laboratory Practice Statements
Attachment 7. Format Diagrams for Submittal Packages and Studies
50
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ATTACHMENT 1
ELEMENTS TO BE INCLUDED IN THE TRANSMITTAL DOCUMENT*
1. Name and address of submitter (or all joint submitters**)
+Smith Chemical Corporation Jones Chemical Company
1234 West Smith Street -and- 5678 Wilson Blvd
Cincinnati, OH 98765 Covington, KY 56789
+Smith Chemical Corp will act as sole agent for all submitters.
2. Regulatory action in support of which this package is
submitted
Use the EPA identification number (e.g. 359-EUP-67) if you know
it. Otherwise describe the type of request (e.g. experimental
use permit, data call-in - of xx-xx-xx date).
3.
4,
Transmittal date
nutted studies
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-
smit tal letter. This remains an acceptable practice so
long as all four elements are included.
* Indicate which of the joint submitters is empowered to
act on behalf of all joint submitters in any matter
concerning data compensation or subsequent use or
release of the data.
Company Official:,
Name Signature
Company Name:
Company .Contact:
Name Phone
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i
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 ProjectID
ABC 47-79
Page l of X
(X is the total number of pages in the study)
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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:
Sicrnature
2. Claim of confidentiality under FIFRA §10(d)(1)(A), (B) » or
(C) .
STATEMENT OF DATA CONFIDENTIALITY CLAIMS
Information claimed confidential on the basis of its falling
within the scope of FIFRA §10(d)(l)(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:
Title
Typed Name
Date:
Signature
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, £or.-which confidentiality claims have been made, to the
submitter, to obtain the confidentiality waiver before they can
be processed.
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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 §lO(d)(1)(A), {B}, or (C) , but for which you claim
confidential 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) each
portion of the study for which you claim
confidentiality.
» Cite the reasons why the cited passage qualifies for
confidential treatment.
• Indicate the length of time--until a specific date or
event, or permanently--for which the information should
be treated as confidential.
» Identify the measures taken to guard against undesired
disclosure of this information.
Ik
» Describe the extent to which the information has been
disclosed, and what precautions have been taken in con-
nection with those disclosures.
• Enclose copies of any pertinent determinations of
confidentiality made by EPA, other Federal agencies, of
courts concerning this information.
» If you assert that disclosure of this information would
be likely to result in substantial harmful effects to
you, describe those harmful effects and explain why
they should be viewed as substantial.
• If you assert that the information in voluntarily sub-
mitted, indicate whether you believe disclosure of this
information might tend to lessen the availability to
SPA of similar information in the future, and if so,
how.
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ATTACHMENT 5
EXAMPLES OP SEVERAL CONFIDENTIAL ATTACHMENTS
Example 1. (Confidential word or phrase that has been deleted
from the study)
CROSS REFERENCE NUMBER I This cross reference number is used in the study
in place of the following words or phrase at the
indicated volume and page references.
DELETED WORDS OR PHRASE;
6
12
100
LINE REASON FOR THE DELETION
14
25
19
Identity of Inert Ingredient
f IFRA REFERENCE
110 (d) (1) (C)
Example 2. (Confidential paragraph(a) that have been deleted from the study)
CROSS REFERENCE NUMBER § This cross reference number is used in the study
in place of the following paragraph(s) at the
indicated volume and page references.
DELETED PARAGRAPH(S}:
PAGE
20.
Reproduce the deleted paragraph(s) here
LINES REASON FOR THE PSLETION FIFRA RSPBRBjjCB
2-17 Description of the quality control process §10(d)(1)(C)
Example 3. {Confidential pages that have been deleted from the study)
CROSS REFERENCE NUMBER 2 This cross reference number noted on a place-
holder page is used in place of the following
whole pages at the indicated volume and page
references.
DELETED PAGE(S): are attached immediately behind this page.
PAGE LINES REASON FOR THE DELETION FIFRA REFERENCE
20. 2-17 Description of the product manufacturing process §10(d)(1)(A)
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ATTACHMENT 6.
SAMPLE GOOD LABORATORY PRACTICE STATEMENTS
Example 1,
This study meets the requirements for 40 CFR Part 160
Submitter :
. Sponsor
Study Director
Example 2.
This study does not meet the requirements of 40 CFR Part 160, and differs
in the following ways:
l.
2.
3.
Submitter_
Sponsor
Study Director_
Example 3.
The submitter of this study was neither the sponsor of this study nor
conducted it, and does not know whether it has been conducted in
accordance with 40 CFR Part 160.
Submitter
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1
ATTACHMENT 7.
FORMAT OP THE SUBHITTAL PACKAGE
Transmitt«l Document.
Related Administrative Materials
(e.g., Method off Support Statement, etc.)
I Other materials about the subnittal
— (e.g., summaries of groups of stadit
to aid in their review).
Studiesi submittad as unique
physical entities, according
to the format below.
FORMAT OP 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,
I Title page of the Confidential
~r ' ... Attachment.
LEGEND
L-f
--r
i
i —"^
,-*—i
i
—• j
Confidantial Attachment.
Supplemental Statement
—- of Confidentiality Claims.
* When flagging requirements
ara finalized.
Documents which nust be submitted as
appropriate to neat established requir*
nts*
I Documents submitted at submitter's option.
1?
57
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58
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PR Notice 91-2
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\
1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PfSTiCIDES
AND TOXIC SUBSTANCES
PR NOTICE 91-2
NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS,
AND REGISTRANTS OF PESTICIDES
ATTENTION: Persons Responsible for Federal Registration of
Pesticide Products.
SUBJECT: Accuracy of Stated Percentages for Ingredients
Statement
I. PURPOSE:
The purpose of this notice is to clarify the Office of
Pesticide Program's policy with respect to the statement of
percentages in a pesticide's label's ingredient statement.
Specifically, the amount (percent by weight) of ingredient(s)
specified in the ingredient statement on the label must be stated
as the nominal concentration of such ingredient(s)» as that term
is defined in 40 CFR 158.153(i). Accordingly, the Agency has
established the nominal concentration as the only acceptable
label claim for the amount of active ingredient in the product.
II. BACKGROUND
For some time the Agency has accepted two different methods
of identifying on the label what percentage is claimed for the
ingredient(s5 contained in a pesticide. Some applicants claimed a
percentage which represented a level between the upper and the
lower certified limits. This was referred to as the nominal
concentration. Other applicants claimed the lower limit as the
percentage of the ingredient(s) that would be expected to be
present in their product at the end of the product's shelf-life.
Unfortunately, this led to a great deal of confusion among the
regulated industry, the regulators, and the consumers as to
exactly how much of a given ingredient was in a given product.
The Agency has established the nominal concentration as the only
acceptable label claim for the amount of active ingredient in the
product.
Current regulations require that the percentage listed in
the active ingredient statement be as precise as possible
reflecting good manufacturing practices 40 CFR 156.10(g)(5). The
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certified limits required for each active ingredient are intended
to encompass any such "good manufacturing practice" variations 40
CFR 158.175(c) (3) .
The upper and lower certified limits, which must be proposed in
connection with a product's registration, represent the amounts
of an ingredient that may legally be present 40 CFR 158,175. The
lower certified limit is used as the enforceable lower limit for
the product composition according to FIFRA section 12(a)(1)(C),
while the nominal concentration appearing on the label would be
the routinely achieved concentration used for calculation of
dosages and dilutions.
The nominal concentration would in fact state the greatest
degree of accuracy that is warranted with respect to actual
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 provide certified limits
for each active, inert ingredient, impurities of toxicological
significance(i.e., upper limit(s) only) and on a case by case
basis as specified by EPA. These limits are to be set based on
representative sampling and chemical analysis(i.e., quality
control) of the product.
The format of the ingredient statement must conform to 40
CFR 156-Labeling Requirements For Pesticides and Devices.
After July 1, 1997, all pesticide ingredient Statements must
be changed to nominal concentration.
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IV. PRODUCTS THAT REQUIRE EFFICACY DATA
All pesticides are required to be efficacious. Therefore,
the certified lower limits may not be lower then the minimum
level to achieve efficacy. This is extremely important for
products which are intended to control pests which threaten the
public health, e.g., certain antimicrobial and rodenticide
products. Refer to 40 CFR 153.640.
In those cases where efficacy limits have been established,
the Agency will not accept certified lower limits which are below
that level for the shelf life of the product.
V. COMPLIANCE SCHEDULE
As described earlier, the purpose of this Notice is to make
the registration process more uniform and more manageable for
both the agency and the regulated community. It is the Agency's
intention to implement the requirements of this notice as
smoothly as possible so as not to disrupt or delay the Agency' s
high priority programs, i.e., reregistration, new chemical, or
fast track (FIFRA section 3(c) (35 (B) . Therefore,
applicants/registrants are expected to comply with the
requirements of this Notice as follows:
(i) Beginning July l, 1991, all new product registrations
submitted to the Agency are to comply with the
requirements of this Notice.
(2) Registrants having products subject to reregistration
under FIFRA section 4 (a) are to comply with the
requirements of this Notice when specific products are
called in by the Agency under Phase V of the
Reregistration Program.
(3) All other products/applications that are not subject to
(1) and (2) above will have until July 1, 1997, to
comply with this Notice. Such applications should note
"Conversion to Nominal Concentrations on the
application form. These types Or amendments will not be
handled as "Fast Track" applications but will be
handled as routine requests.
VI. FOR FURTHER INFORMATION
Contact Tyrone Aiken for information or questions concerning
this notice on (703) 308-7031.
Ann* E. tindaay, Director
Diviaicn (M-75O5
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APPENDIX F
Generic Data Call-In
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DATA CALUN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient(s) identified in Attachment A of this Notice, the Data Call-in Chemical Status Sheet.
to submit certain data as noted herein to the U.S. Environmental Protection Agency (EPA, the
Agency). These data are necessary to maintain the continued registration of your product(s)
containing this active ingredient(s). Within 90 days after you receive this Notice you must
respond as set forth in Section ffi below. Your response must state:
1 . how you will comply with the requirements set forth in this Notice and its Attachments
A through D; or,
2. why you believe you are exempt from the requirements listed in this Notice and in
Attachment C, Requirements Status and Registrant's Response Form, (see section ni-B);
or,
3. why you believe EPA should not require your submission of data in the manner specified
by this Notice (see section JH-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
your product(s) subject to this Notice will be subject to suspension. We have provided a list of
all of your products subject to this Notice in Attachment B, Data Call-In Response Form, as well
as a list of all registrants who were sent this Notice (Attachment D).
authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-0107
(expiration date 12-31-92).
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I
This Notice is divided into six sections and five Attachments, The Notice itself contains
information and instructions applicable to all Data Call-in Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You Are Receiving This Notice
Section n - Data Required By This Notice
Section in - Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable Adverse
Effects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
Attachment A - Data Call-in Chemical Status Sheet
Attachment B - Data Call-In Response Form
Attachment C - Requirements Status And Registrant's Response Form
Attachment D - List Of All Registrants Sent This Data Call-In Notice
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient(s) and reevaluated the
data needed to support continued registration of the subject active ingredient(s). This
reevaluation identified additional data necessary to assess the health and safety of the continued
use of products containing this active ingredient(s). You have been sent this Notice because you
have product(s) containing the subject active ingredient(s),
SECTION H. DATA REQUIRED BY TfflS NOTICE
A. DATA REQUIRED
The data required by this Notice are specified in Attachment C, Requirements
Status and Registrant's Response Form. Depending on the results of the studies required
in this Notice, additional testing may be required.
B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements
specified in Attachment C, Requirements Status and Registrant's Response Form, within
the time frames provided.
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C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test
standards outlined in the Pesticide Assessment Guidelines for those studies for which
guidelines have been established.
These EPA Guidelines are available from the National Technical Information
Service (NTTS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel:
703-487:4650).
Protocols approved by the Organization for Economic Cooperation and
Development (OECD) are also acceptable if the OECD-recommended test standards
conform to those specified in the Pesticide Data Requirements regulation (40 CFR §
158.70). When using the OECD protocols, they should be modified as appropriate so
that the data generated by the study will satisfy the requirements of 40 CFR § 158.
Normally, the Agency will not extend deadlines for complying with data requirements
when the studies were not conducted in accordance with acceptable standards. The
OECD protocols are available from OECD, 1750 Pennsylvania Avenue N.W.,
Washington, D.C. 20006.
All new studies and proposed protocols submitted in response to this Data Call-in
Notice must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
D, REGISTRANTS RECEIVING PREVIOUS SECTION 3fc^rB) NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-In does not in any way supersede
or change the requirements of any previous Data CaU-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 m. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
A- SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice must be submitted to
the -Agency within 90-day s after your receipt of this Notice. Failure to adequately
respond to this Notice within 90 days of your receipt will be a basis for issuing a Notice
of Intent to Suspend (NOIS) affecting your products. This and other bases for issuance
of NOIS due to failure to comply with this Notice are presented in Section IV-A and IV-
B.
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B. OPTIONS FOR RESPONDING TO THE AGENCY
The options for responding to this Notice are: 1) voluntary cancellation, 2) delete
use(s), (3) claim generic data exemption, (4) agree to satisfy the data requirements
imposed by this Notice or (5) request a data waiver(s).
A discussion of how to respond if you chose the Voluntary Cancellation option,
the Delete Use(s) option or the Generic Data Exemption option is presented below. A
discussion of the various options available for satisfying the data requirements of this
Notice is contained in Section DI-C. A discussion of options relating to requests for data
waivers is contained in Section ffl-D,
There are two forms that accompany this Notice of which, depending upon your
response, one or both must be used in your response to the Agency. These forms are
the Data-Call-in Response Form (Attachment B) and the Requirements Status and
Registrant's Response Form (Attachment C). The Data Call-in Response Form must be
submitted as part of every response to this Notice, Please note that the company's
authorized representative is required to sign the first page of the Data Call-In Response
Form and Requirements Status and Registrant's Response Form (if this form is required)
and initial any subsequent pages. The forms contain separate detailed instructions on the
response options. Do not alter the printed material. If you have questions or need
assistance in preparing your response, call or write the contact person identified in
Attachment A.
1. Voluntary Cancellation - You may avoid the requirements of this Notice
by requesting voluntary cancellation of your product(s) containing the active
ingredient(s) that is the subject of this Notice. If you wish to voluntarily cancel
your product, you must submit a completed Data Call-In Response Form.
indicating your election of this option. Voluntary cancellation is item number 5
on the Data Call-In Response Form. If you choose this option, this is the only
form that you are required to complete.
If you choose to voluntarily cancel your product, further sale and
distribution of your product after the effective date of cancellation must be in
accordance with the Existing Stocks provisions of this Notice which are contained
in Section IV-C.
2. Use Deletion - You may avoid the requirements of this Notice by
eliminating the uses of your product to which the requirements apply. If you
wish to amend^ow registration to delete uses, you must submit the Requirements
Status and Registrant's Response Form, a completed application for amendment,
a copy of your proposed amended labeling, and all other information required for
processing the application. Use deletion is option number 7 on the Requirements
Status and Registrant's Response Form. You must also complete a Data Call-In
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Response Form by signing the certification, item number 8. Application forms for
amending registrations may be obtained from the Registration Support and
Emergency Response Branch, Registration Division, (703) 308-8358.
If you choose to delete the use(s) subject to this Notice or uses subject to
specific data requirements, further sale, distribution, or use of your product after
one year from the due date of your 90 day response, must bear an amended label.
3. Generic Data Exemption - Under section 3(c)(2)(D) of FIFRA, an
applicant for registration of a product is exempt from the requirement to submit
or cite generic data concerning an active ingredient(s) if the active ingredient(s)
in the product is derived exclusively from purchased, registered pesticide products
containing the active ingredient(s). EPA has concluded, as an exercise of its
discretion, that it normally will not suspend the registration of a product which
would qualify and continue to qualify for the generic data exemption in section
3(c)(2)(D) of FEPRA. To qualify, all of the following requirements must be met:
a. The active ingredient(s) in your registered product must be present
solely because of incorporation of another registered product which
contains the subject active ingredient(s) and is purchased from a source
not connected with you; and,
b. every registrant who is the ultimate source of the active
ingredient(s) in your product subject to this DCI must be in compliance
with the requirements of this Notice and must remain in compliance; and
c. you must have provided to EPA an accurate and current
"Confidential Statement of Formula" for each of your products to which
this Notice applies.
To apply for the Generic Data Exemption you must submit a completed
Data Call-In Response Form. Attachment B and all supporting documentation.
The Generic Data Exemption is item number 6a on the Data CalHn Response
Form. If you claim a generic data exemption you are not required to complete
the Requirements Status and Registrant's Response Form. Generic Data
Exemption cannot be selected as an option for product specific data.
If you are granted a Generic Data Exemption, you rely on the efforts of
4>ther persons to provide the Agency with the required data. If the registrant(s)
who have committed to generate and submit the required data fail to take
appropriate steps to meet the requirements or are no longer in compliance with
this Data Call-In Notice, the Agency will consider that both they and you are not
in compliance and will normally initiate proceedings to suspend the registrations
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of both your and their product(s), unless you commit to submit and do submit the
required data within the specified time. In such cases the Agency generally will
not grant a time extension for submitting the data.
4. Satisfying the Data Requirements of this Notice - There are various
options available to satisfy the data requirements of this Notice. These options
are discussed in Section ffl-C of this Notice and comprise options 1 through 6 on
the Requirements Status and Registrant's Response Form and option 6b and 7 on
the Data Call-In Response Form. If you choose option 6b or 7, you must submit
both forms as well as any other information/data pertaining to the option chosen
to address the data requirement.
5. Request for Data Waivers. Data waivers are discussed in Section ffl-D
of this Notice and are covered by options 8 and 9 on the Requirements Status and
Registrant's Response Form. If you choose one of these options, you must
submit both forms as well as any other information/data pertaining to the option
chosen to address the data requirement.
C. SATISFYING THE DATA REQUIREMENTS OP THIS NOTICE
If you acknowledge on the Data Call-In Response Form that you agree to satisfy
the data requirements (i.e. you select option 6b and/or 7), then you must select one of
the six options on the Requirements Status and Registrant's Response Form related to
data production for each data requirement. Your option selection should be entered
under item number 9, "Registrant Response." The six options related to data production
are the first six options discussed under item 9 in the instructions for completing the
Requirements Status and Registrant's Response Form. These six options are listed
immediately below with information in parentheses to guide registrants to additional
instructions provided in this Section. The options are:
1. I will generate and submit data within the specified time frame
(Developing Data),
2. I have entered into an agreement with one or more registrants to develop
data jointly (Cost Sharing),
3. I have made offers to cost-share (Offers to Cost Share),
4, I am submitting an existing study that has not been submitted previously
to the Agency by anyone (Submitting an Existing Study),
5. I am submitting or citing data to upgrade a study classified by EPA as
partially acceptable and upgradeable (Upgrading a Study),
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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 confonnance with
Agency deadlines and with other Agency requirements as referenced herein and
in the attachments. All data generated and submitted must comply with the Good
Laboratory Practice (GLP) rale (40 CFR Part 160), be conducted according to the
Pesticide Assessment Guidelines (PAG), and be in confonnance with the
requirements of PR Notice 86-5. In addition, certain studies require Agency
approval of test protocols in advance of study initiation. Those studies for which
a protocol must be submitted have been identified in the Requirements Status and
Registrant's Response Form and/or footnotes to the form. If you wish to use a
protocol which differs from the options discussed in Section n-C of this Notice,
you must submit a detailed description of the proposed protocol and your reason
for wishing to use it. The Agency may choose to reject a protocol not specified
in Section n-C. If the Agency rejects your protocol you will be notified in
writing, however, you should be aware that rejection of a proposed protocol will
not be a basis for extending the deadline for submission of data,
A progress report must be submitted for each study within 90 days from
the date you are required to commit to generate or undertake some other means
to address that study requirement, such as making an offer to cost-share or
agreeing to share in the cost of developing that study. A 90-day progress report
must be submitted for all studies. This 90-day progress report must include the
date the study was or will be initiated and, for studies to be started within 12
months of commitment, the name and address of the laboratory(ies) or individuals
who are or will be conducting the study.
In addition, if the time frame for submission of a final report is more than
1 year, interim reports must be submitted at 12 month intervals from the date you
are required to commit to generate or otherwise address the requirement for the
study. In addition to the other information specified in the preceding paragraph,
at a minimum, a brief description of current activity on and the status of the study
must be included as well as a full description of any problems encountered since
the last progress report.
T4ie time frames in the Requirements Status and Registrant's Response
Form are the time frames that the Agency is allowing for the submission of
completed study reports or protocols. The noted deadlines run from the date of
the receipt of this Notice by the registrant. If the data are not submitted by the
deadline, each registrant is subject to receipt of a Notice of Intent to Suspend the
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affected registration(s).
If you cannot submit the data/reports to the Agency in the time required
by this Notice and intend to seek additional time to meet the requirement(s), you
must submit a request to the Agency which includes: (1) a detailed description
of the expected difficulty and (2) a proposed schedule including alternative dates
for meeting such requirements on a step-by-step basis. You must explain any
technical or laboratory difficulties and provide documentation from the laboratory
performing the testing. While EPA is considering your request, the original
deadline remains. The Agency will respond to your request in writing. If EPA
does not grant your request, the original deadline remains. Normally, extensions
can be requested only in cases of extraordinary testing problems beyond the
expectation or control of the registrant. Extensions will not be given in
submitting the 90-day responses. Extensions will not be considered if the request
for extension is not made in a timely fashion; in no event shall an extension
request be considered if it is submitted at or after the lapse of the subject
deadline.
Option 2. Agreement to Share in Cost to Develop Data —
If you choose to enter into an agreement to share in the cost of producing
the required data but will not be submitting the data yourself, you must provide
the name of the registrant who will be submitting the data. You must also
provide EPA with documentary evidence that an agreement has been formed.
Such evidence may be your letter offering to join in an agreement and the other
registrant's acceptance of your offer, or a written statement by the parties that an
agreement exists. The agreement to produce the data need not specify all of the
terms of the final arrangement between the parties or the mechanism to resolve
the terms. Section 3(c)(2)(B) provides that if the parties cannot resolve the terms
of the agreement they may resolve their differences through binding arbitration.
Option 3, Offer to Share in the Cost of Data Development —
If you have made an offer to pay in an attempt to enter into an agreement
or amend an existing agreement to meet the requirements of this Notice and have
been unsuccessful, you may request EPA (by selecting this option) to exercise its
discretion not to suspend your registration(s), although you do not comply with
the data submission requirements of this Notice. EPA has determined that as a
general policy, absent other relevant considerations, it will not suspend the
registration of a product of a registrant who has in good faith sought and
continues to seek to enter into a joint data development/cost sharing program, but
the other registrant(s) developing the data has refused to accept your offer. To
qualify for this option, you must submit documentation to the Agency proving
that you have made an offer to another registrant (who has an obligation to submit
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data) to share in the burden of developing that data. You must also submit to the
Agency a completed EPA Form 8570^32, Certification of Offer to Cost Share in
the Development of Data, Attachment E. In addition, you must demonstrate that
the other registrant to whom the offer was made has not accepted your offer to
enter into a cost sharing agreement by including a copy of your offer and proof
of the other registrant's receipt of that offer (such as a certified mail receipt).
Your offer must, in addition to anything else, offer to share in the burden of
producing the data upon terms to be agreed or failing agreement to be bound by
binding arbitration as provided by HFRA section 3(c)(2)(B)(iii) and must not
qualify this offer. The other registrant must also inform EPA of its election of
an option to develop and submit the data required by this Notice by submitting
a Data Call-In Response Form and a Requirements Status and Registrant's
Response Form committing to develop and submit the data required by this
Notice.
In order for you to avoid suspension under this option, you may not
withdraw your offer to share in the burdens of developing the data. In addition,
the other registrant must fulfill its commitment to develop and submit the data as
required by this Notice. If the other registrant fails to develop the data or for
some other reason is subject to suspension, your registration as well as that of the
other registrant will normally be subject to initiation of suspension proceedings,
unless you commit to submit, and do submit the required data in the specified
time frame. In such cases, the Agency generally will not grant a time extension
for submitting the data.
Option 4. Submitting an Existing Study —
If you choose to submit an existing study in response to this Notice, you
must determine that the study satisfies the requirements imposed by this Notice.
You may only submit a study that has not been previously submitted to the
Agency or previously cited by anyone. Existing studies are studies which predate
issuance of this Notice. Do not use this option if you are submitting data to
upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the study is not
acceptable, the Agency will require you to comply with this Notice, normally
without an extension of the required date of submission. The Agency may
determine at any time that a study is not valid and needs to be repeated.
To-meet 4he requirements of the DCI Notice for submitting an existing
study, all of the following three criteria must be clearly met:
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a. You must certify at the time that the existing study is submitted
that the raw data and specimens from the study are available for audit and
review and you must identify where they are available. This must be
done in accordance with the requirements of the Good Laboratory Practice
(GLP) regulation, 40 CFR Part 160. As stated in 40 CFR 160.3(7) " raw
data means any laboratory worksheets, records, memoranda, notes, or
exact copies thereof, that are the result of original observations and
activities of a study and are necessary for the reconstruction and
evaluation of the report of that study. In the event that exact transcripts
of raw data have been prepared (e.g., tapes which have been transcribed
verbatim, dated, and verified accurate by signature), the exact copy or
exact transcript may be substituted for the original source as raw data.
Raw data may include photographs, microfilm or microfiche copies,
computer printouts, magnetic media, including dictated observations, and
recorded data from automated instruments." The term "specimens",
according to 40 CFR 160.3(7), means "any material derived from a test
system for examination or analysis."
b. Health and safety studies completed after May 1984 must also
contain all GLP-required quality assurance and quality control
information, pursuant to the requirements of 40 CFR Part 160.
Registrants must also certify at the time of submitting the existing study
that such GLP information is available for post-May 1984 studies by
including an appropriate statement on or attached to the study signed by
an authorized official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for
the Guideline relevant to the study provided in the FIFRA Accelerated
Reregistration Phase 3 Technical Guidance and that the study has been
conducted according to the Pesticide Assessment Guidelines (PAG) or
meets the purpose of the PAG (both available from NTIS). A study not
conducted according to the PAG may be submitted to the Agency for
consideration if the registrant believes that the study clearly meets the
purpose of the PAG. The registrant is referred to 40 CFR 158.70 which
states the Agency's policy regarding acceptable protocols. If you wish to
submit the study, you must, in addition to certifying that the purposes of
the PAG are met by the study, clearly articulate the rationale why you
believe the study meets the purpose of the PAG, including copies of any
supporting information or data. It has been the Agency's experience that
studies-completed prior to January 1970 rarely satisfied the purpose of the
PAG and that necessary raw data are usually not available for such
studies.
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If you submit an existing study, you must certify that the study
meets all requirements of the criteria outlined above.
If EPA has previously reviewed a protocol for a study you are
submitting, you must identify any action taken by the Agency on the
protocol and must indicate, as part of your certification, the manner in
which all Agency comments, concerns, or issues were addressed in the
final protocol and study.
If you know of a study pertaining to any requirement in this Notice
which does not meet the criteria outlined above but does contain factual
information regarding unreasonable adverse effects, you must notify the
Agency of such a study. If such a study is in the Agency's files, you
need only cite it along with the notification. If not in the Agency's Hies,
you must submit a summary and copies as required by PR Notice 86-5,
Option 5. Upgrading a Study ~
If a study has been classified as partially acceptable and upgradeable, you
may submit data to upgrade that study. The Agency will review the data
submitted and determine if the requirement is satisfied. If the Agency decides the
requirement is not satisfied, you may still be required to submit new data
normally without any time extension. Deficient, but upgradeable studies will
normally be classified as supplemental. However, it is important to note that not
all studies classified as supplemental are upgradeable. If you have questions
regarding the classification of a study or whether a study may be upgraded, call
or write the contact person listed in Attachment A. If you submit data to upgrade
an existing study you must satisfy or supply information to correct §11 deficiencies
in the study identified by EPA. You must provide a clearly articulated rationale
of how the deficiencies have been remedied or corrected and why the study
should be rated as acceptable to EPA. Your submission must also specify the
MRID number(s) of the study which you are attempting to upgrade and must be
in conformance with PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a study
classified as unacceptable and determined by the Agency as not capable of being
upgraded.
This option should also be used to cite data that has been previously
submitted -te-upfrade 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 MRED
number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4
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above, apply to all data submissions intended to upgrade studies. Additionally
your submission of data intended to upgrade studies must be accompanied by a
certification that you comply with each of those criteria as well as a certification
regarding protocol compliance with Agency requirements.
Option 6. Citing Existing Studies —
If you choose to cite a study that has been previously submitted to EPA,
that study must have been previously classified by EPA as acceptable or it must
be a study which has not yet been reviewed by the Agency, Acceptable
toxicology studies generally will have been classified as "core-guideline" or "core
minimum." For ecological effects studies, the classification generally would be
a rating of "core." For all other disciplines the classification would be
"acceptable." With respect to any studies for which you wish to select this option
you must provide the MRID number of the study you are citing and, if the study
has been reviewed by the Agency, you must provide the Agency's classification
of the study.
If you are citing a study of which you are not the original data submitter,
you must submit a completed copy of EPA Form 8570-31, Certification with
Respect to Data Compensation Requirements.
D. REQUESTS FOR DATA WAIVERS
There are two types of data waiver responses to this Notice. The first is a request
for a low volume/minor use waiver and the second is a waiver request based on your
belief that the data requirement(s) are inapplicable and do not apply to your product.
1. Low Volume/Minor Use Waiver -- Option 8 on the Requirements Status
and Registrant's Response Form. Section 3(c)(2)(A) of FIFRA requires EPA to
consider the appropriateness of requiring data for low volume, minor use
pesticides. In implementing this provision EPA considers as low volume
pesticides only those active ingredient(s) whose total production volume for all
pesticide registrants is small. In determining whether to grant a low volume,
minor use waiver the Agency will consider the extent, pattern and volume of use,
the economic incentive to conduct the testing, the importance of the pesticide, and
the exposure and risk from use of the pesticide. If an active ingredient(s) is used
for both high volume and low volume uses, a low volume exemption will not be
approved. If all uses of an active ingredient(s) are low volume and the combined
volumes^er-aH-uses are also low, then an exemption may be granted, depending
on review of other information outlined below. An exemption will not be granted
if any registrant of the active ingredient(s) elects to conduct the testing. Any
registrant receiving a low volume minor use waiver must remain within the sales
figures in their forecast supporting the waiver request in order to remain qualified
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for such waiver. If granted a waiver, a registrant will be required, as a condition
of the waiver, to submit annual sales reports. The Agency will respond to
requests for waivers in writing.
To apply for a low volume, minor use waiver, you must submit the
following information, as applicable to your product(s), as part of your 90-day
response to this Notice:
a. Total company sales (pounds and dollars) of all registered
product(s) containing the active ingredient(s). If applicable to the active
ingredient(s), include foreign sales for those products that are not
registered in this country but are applied to sugar (cane or beet), coffee,
bananas, cocoa, and other such crops. Present the above information by
year for each of the past five years.
b. Provide an estimate of the sales (pounds and dollars) of the active
ingredient(s) for each major use site. Present the above information by
year for each of the past five years.
c. Total direct production cost of product(s) containing the active
ingredients) by year for the past five years. Include information on raw
material cost, direct labor cost, advertising, sales and marketing, and any
other significant costs listed separately.
d. Total indirect production cost (e.g. plant overhead, amortized plant
and equipment) charged to product(s) containing the active ingredient(s)
by year for the past five years. Exclude all non-recurring costs that were
directly related to the active ingredient(s), such as costs of initial
registration and any data development.
e. A list of each data requirement for which you seek a waiver.
Indicate the type of waiver sought and the estimated cost to you (listed
separately for each data requirement and associated test) of conducting
the testing needed to fulfill each of these data requirements.
f. A list of each data requirement for which you are not seeking any
waiver and the estimated cost to you (listed separately for each data
requirement and associated test) of conducting the testing needed to fulfill
each of these data requirements.
g. For each of the next ten years, a year-by-year forecast of company
sales (pounds and dollars) of the active ingredient(s), direct production
costs of product(s) containing the active ingredient(s) (following the
parameters in item c above), indirect production costs of product(s)
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containing the active ingredient(s) (following the parameters in item d
above), and costs of data development pertaining to the active
ingredient(s).
h. A description of the importance and unique benefits of the active
ingredient(s) to users. Discuss the use patterns and the effectiveness of
the active ingredient(s) relative to registered alternative chemicals and
non-chemical control strategies. Focus on benefits unique to the active
ingredient(s), providing information that is as quantitative as possible. If
you do not have quantitative data upon which to base your estimates, then
present the reasoning used to derive your estimates. To assist the Agency
in determining the degree of importance of the active ingredient(s) in
terms of its benefits, you should provide information on any of the
following factors, as applicable to your produces):
(1) documentation of the usefulness of the active ingredient(s)
in Integrated Pest Management, (b) description of the beneficial impacts
on the environment of use of the active ingredient(s), as opposed to its
registered alternatives, (c) information on the breakdown of the active
ingredient(s) after use and on its persistence in the environment, and (d)
description of its usefulness against a pest(s) of public health significance.
Failure to submit sufficient information for the Agency to make a determination
regarding a request for a low volume minor use waiver will result in denial of the request
for a waiver.
2. Request for Waiver of Data -Option 9 on the Requirements Status and
Registrant's Response Form. This option may be used if you believe that a
particular data requirement should not apply because the corresponding use is no
longer registered or the requirement is inappropriate. You must submit a
rationale explaining why you believe the data requirements should not apply.
You must also submit the current label(s) of your produces) and, if a current
copy of your Confidential Statement of Formula is not already on file you must
submit a current copy.
You will be informed of the Agency's decision in writing. If the Agency
determines that the data requirements of this Notice do not apply to your
product(s), you will not be required to supply the data pursuant to section
3(c)(2)(B). If EPA determines that the data are required for your product(s). you
of meetin the reuirements of this Notice within the time
frame provided by this Notice. Within 30 days of your receipt of the Agency's
written decision, you must submit a revised Requirements Status and Registrant's
Response Form indicating the option chosen.
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IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
A. NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this
Notice due to failure by a registrant to comply with the requirements of this Data Call-in
Notice, pursuant to FIFRA section 3(c)(2)(B). Events which may be the basis for
issuance of a Notice of Intent to Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your
receipt of this Notice,
2. Failure to submit on the required schedule an acceptable proposed or final
protocol when such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on
a study as required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by
this Notice.
5. Failure to take a required action or submit adequate information pertaining
to any option chosen to address the data requirements (e.g., any required
action or information pertaining to submission or citation of existing
studies or offers, arrangements, or arbitration on the sharing of costs or
the formation of Task Forces, failure to comply with the terms of an
agreement or arbitration concerning joint data development or failure to
comply with any terms of a data waiver).
6, Failure to submit supportable certifications as to the conditions of
submitted studies, as required by Section UI-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in
the cost of developing data and provided proof of the registrant's receipt
of such offer, or failure of a registrant on whom you rely for a generic
data exemption either to;
a. inform EPA of intent to develop and submit the data required by
this Notice on a Data Call-In Response Form and a Requirements Status
and Registrant's Response Form: or,
b. fulfill the commitment to develop and submit the data as required
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by this Notice; or,
c, otherwise take appropriate steps to meet the requirements stated in
this Notice, unless you commit to submit and do submit the required data
in the specified time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at
any time following the issuance of this Notice.
B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required
time) is unacceptable and constitutes a basis for issuance of a Notice of Intent to
Suspend. The grounds for suspension include, but are not limited to, failure to meet any
of the following:
1. EPA requirements specified in the Data Call-In Notice or other documents
incorporated by reference (including, as applicable, EPA Pesticide Assessment
Guidelines, Data Reporting Guidelines, and GeneTox Health Effects Test
Guidelines) regarding the design, conduct, and reporting of required studies.
Such requirements include, but are not limited to, those relating to test material,
test procedures, selection of species, number of animals, sex and distribution of
animals, dose and effect levels to be tested or attained, duration of test, and, as
applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the
incorporation of any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner
of reporting, the completeness of results, and the adequacy of any required
supporting (or raw) data, including, but not limited to, requirements referenced
or included in this Notice or contained in PR 86-5. All studies must be submitted
in the form of a final report; a preliminary report will not be considered to fulfill
the submission requirement.
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 Federal Insecticide, Fungicide, and
Rodenticide Act.
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The Agency has determined that such disposition by registrants of existing stocks
for a suspended registration when a section 3(c)(2)(B) data request is outstanding would
generally not be consistent with the Act's purposes. Accordingly, the Agency anticipates
granting registrants permission to seH, distribute, or use existing stocks of suspended
product(s) only in exceptional circumstances. If you believe such disposition of existing
stocks of your product(s) which may be suspended for failure to comply with this Notice
should be permitted, you have the burden of clearly demonstrating to EPA that granting
such permission would be consistent with the Act. You must also explain why an
"existing stocks" provision is necessary, including a statement of the quantity of existing
stocks and your estimate of the time required for their sale, distribution, and use. Unless
you meet this burden the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this
Notice and your product is in fiill compliance with all Agency requirements, you will
have, under most circumstances, one year from the date your 90 day response to this
Notice is due, to sell, distribute, or use existing stocks. Normally, the Agency will allow
persons other than the registrant such as independent distributors, retailers and end users
to sell, distribute or use such existing stocks until the stocks are exhausted. Any sale,
distribution or use of stocks of voluntarily cancelled products containing an active
ingredient(s) for which the Agency has particular risk concerns will be determined on
case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period
required by this Notice will not result in the Agency granting any additional time to sell,
distribute, or use existing stocks beyond a year from the date the 90 day response was
due unless you demonstrate to the Agency that you are in full compliance with all
Agency requirements, including the requirements of this Notice. For example, if you
decide to voluntarily cancel your registration six months before a 3 year study is
scheduled to be submitted, all progress reports and other information necessary to
establish that you have been conducting the study in an acceptable and good faith manner
must have been submitted to the Agency, before EPA will consider granting an existing
stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE UNREASONABLE
Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on die-environmentby the pesticide, the registrant shall submit the information
to the Agency. Registrants must notify the Agency of any factual information they have, from
whatever source, including but not limited to interim or preliminary results of studies, regarding
unreasonable adverse effects on man or the environment. This requirement continues as long
as the products are registered by the Agency.
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SECTION VI. - INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person listed in Attachment A, the Data Call-In Chemical Status Sheet.
All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-in Response Form (Attachment B) and
a completed Requirements Status and Registrant's Response Form (Attachment C) and any other
documents required by this Notice, and should be submitted to the contact person identified in
Attachment A. If the voluntary cancellation or generic data exemption option is chosen, only the
Data Call-in Response Form need be submitted.
The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in response to this Notice,
Sincerely yours,
Peter P. Caulkins Ph.D., Acting Director
Special Review
and Reregistration Division
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Page 1 of 1
United Stages Envirc .imental Protection Agency
Washingt.on, D.C. 20460
*>*QUIRKMKNTS STATUS AND REGISTRANT'S RBSPONSB
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested
Use additional sheet(s) if necessary
1. Company nane and Address
4. Guideline
Reojui reswnt
Hunter
61-1
61-2 (a)
61-2 (b)
62-3, / • .'•• . .:..
62-2
62-3 '..-. • ;..:;
5. Study Title
Chealcal Identity
Begin. »it, 1 erifg, proc .-;;--:::-': •
Discussion of Iftfxiritles
Preliminary *n«ly»i*
Certification of Units
,'-••,---•-•
Analytical NetlwT
f
2. Case i and Name
3150 Wood oils and gums
Chemical 9 and Name 040505
Cedarwood oil
Progress
Reports
1
2
3
6. Use
Pattern
all
all
all
all
all
all
7. Test
Substance
TGAI
TfiAI
TGAI
TGA!
TGAI
TGAI
10. Certification
1 certify that the statement* made on this fom and all attachments are true, accurate, and complete.
i acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable Ian.
Signature and Title of Company's Authorized Representative
12. Name of Company Contact
8.
Fra
8
8
8
8
8
8
Fora Approved
OMB No. 2070-010?
2070-005?
Approval Expire* 03-31-96
on this font.
3. Date and Type of DC I
GENERIC
Tine
me
mos.
mos.
mos,
mos,
mos.
mos.
9. Registrant
Response
11. Date
13. Phone Nunber
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Attachment A
Chemical Status Sheet
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CEDARWOOD OIL: DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Call-In Notice because you have a product
containing cedarwood oil.
This Generic Data Call-in Chemical Status Sheet, contains an overview of data required
by this notice, and a point of contact for inquiries pertaining to the reregistration of cedarwood
oil. This attachment is to be used in conjunction with (1) the Generic Data Call-In Notice, (2)
the Generic Data Call-In Response Form (Attachment B), (3) the Requirements Status and
Registrant's Form (Attachment C), (4) a Est of registrants receiving this DCI (Attachment D),
(5) the EPA Acceptance Criteria (Attachment E), and (6) the Cost Share and Data Compensation
Forms in replying to this cedarwood oil Generic Data Call-In (Attachment F). Instructions and
guidance accompany each form.
The additional data requirements needed to complete the generic database for cedarwood
oil are contained in the Requirements Status and Registrant's Response. Attachment C. The
Agency has concluded that additional product chemistry data on cedarwood oil needed. These
data are needed to fully complete the reregistration of all eligible cedarwood oil products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic data requirements and procedures
established by this Notice, please contact Virginia Dietrich at (703) 308-8157. All responses
to this Notice for the generic data requirements should be submitted to;
Virginia Dietrich, Chemical Review Manager
Accelerated Reregistration Branch
Special Review and Registration Division (7508W)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Cedapweod Oil
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Attachment B
Generic DCI Response Forms (Form A) plus Instructions
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SPECIFIC INSTRUCTIONS FOR THE DATA CALL-IN RESPONSE FORM
This Form is designed to be used to respond to call-ins for generic and product specific data for
the purpose of reregistering pesticides under the Federal Insecticide Fungicide and Rodenticide
Act. Fill out this form each time you are responding to a data call-in for which EPA has sent
you the form entitled "Requirements Status and Registrant's Response."
Items 1-4 will have been preprinted on the form Items 5 through 7 must be completed by the
registrant as appropriate Items 8 through 11 must be completed by the registrant before
submitting a response to the Agency.
Public reporting burden for this collection of information is estimated to average 15 minutes per
response, including time for reviewing instructions, searching existing data sources, gathering
and maintaining the data needed, and completing and reviewing the collection of information.
Send comments regarding the burden estimate or any other aspect of this collection of
information, including suggesting for reducing this burden, to Chief, Information Policy Branch,
PM-223, U S Environmental Protection Agency, 401 M St , S W , Washington, D C 20460;
and to the Office of Management and Budget, Paperwork Reduction Project 2070-0107,
Washington, D C 20503
INSTRUCTIONS
Item 1 This item identifies your company name, number and address.
Item 2 This item identifies the ease number, ease name, EPA chemical number and
chemical name.
Item 3 This item identifies the date and type of data call-in.
Item 4 This item identifies the EPA product registrations relevant to the data call-in.
Please note that you are also responsible for informing the Agency of your
response regarding any product that you believe may be covered by this data
call-in but that is not listed by the Agency in Item 4. You must bring any such
apparent omission to the Agency's attention within the period required for
submission of this response form.
Item 5 Cheek this item for each product registration you wish to cancel voluntarily. If
a registration number is listed for a product for which you previously requested
voluntary cancellation, indicate in Item 5 the date of that request. You do not
need te-comptete-aay item on the Requirements Status and Registrant's Response
Form for any product that is voluntarily cancelled.
Item 6a Check this item if this data call-in is for generic data as indicated in Item 3 and
if you are eligible for a Generic Data Exemption for the chemical listed in Item
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2 and used in the subject product. By electing this exemption, you agree to the
terms and conditions of a Generic Data Exemption as explained in the Data
Call-In Notice.
If you are eligible for or claim a Generic Data Exemption, enter the EPA
registration Number of each registered source of that active ingredient that you
use in your product.
Typically, if you purchase an EPA-registered product from one or more other
producers (who, with respect to the incorporated product, are in compliance with
this and-any other outstanding Data Call-In Notice), and incorporate that product
into all your products, you may complete this item for all products listed on this
form If, however, you produce the active ingredient yourself, or use any
unregistered product (regardless of the fact that some of your sources are
registered), you may not claim a Generic Data Exemption and you may not select
this item.
Item 6b Check this Item if the data call-in is a generic data call-in as indicated in Item 3
and if you are agreeing to satisfy the generic data requirements of this data
call-in. Attach the Requirements Status and Registrant's Response Form that
Indicates how you will satisfy those requirements.
Item 7a Check this item only if this call-in is a data call-in as indicated in Item 3 for a
manufacturing use product (MUP), and if your product is a manufacturing use
product for which you agree to supply product-specific data. Attach the
Requirements Status and Registrants' Response Form that indicates how you will
satisfy those requirements.
Item 7b Check this item only if this call-in is a data call-in for an end use product (EUP)
as indicated in Item 3 and if your product is an end use product for which you
agree to supply product-specific data. Attach the Requirements Status and
Registrant's Response Form that indicates how you will satisfy those
requirements.
Item 8 This certification statement must be signed by an authorized representative of
your company and the person signing must include his/her title. Additional pages
used in your response must be initialled and dated in the space provided for the
certification.
Item 9 -Enter-the date of signature.
Item 10 Enter the name of the person EPA should contact with questions regarding your
response.
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Item 11 Enter the phone number of your company contact.
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Attachment C
Requirements Status and Registrants' Response Forms
(Form B) plus Instructions
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SPECIFIC INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANTS RESPONSE FORM
Generic Data
This form is designed to be used for registrants to respond to call-in- for generic and .
product-specific data as part of EPA's reregistration program under the Federal Insecticide
Fungicide and Rodemtcide Act. Although the form is the same for both product specific and
generic data, instructions for completing the forms differ slightly. Specifically, options for
satisfying product specific data requirements do not include (1) deletion of uses or (2) request
for a low volume/minor use waiver. These instructions are for completion of generic data
requirements.
EPA has developed this form individually for each data call-in addressed to each registrant,
and has preprinted this form with a number of items. DO NOT use this form for any other
active ingredient.
Items 1 through 8 (inclusive) will have been preprinted on the form. You must complete all
other items on this form by typing or printing legibly.
Public reporting burden for this collection of information is estimated to average 30 minutes
per response, including time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing the collection of
information. Send comments regarding the burden estimate or any other aspect of this
collection of information, including suggesting for reducing this burden, to Chief,
Information Policy Branch, PM-223, U.S. Environmental Protection Agency, 401 M St.,
S.W., Washington, D.C. 20460; and to the Office of Management and Budget, Paperwork
Reduction Project 2070-0107, Washington, D.C. 20503.
INSTRUCTIONS
Item 1. This item identifies your company name, number, and address.
Item 2, This item identifies the case number, case name, EPA chemical number and
chemical name.
Item 3, This item identifies the date and type of data call-in.
Item 4. This item identifies the guideline reference numbers of studies required to
support the~pred«et(s) being reregistered. These guidelines, in addition to
requirements specified in the Data Call-in Notice, govern the conduct of the
required studies.
Item 5. This item identifies the study title associated with the guideline reference
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number and whether protocols and 1, 2, or 3-year progress reports are
required to be submitted in connection with the study. As noted in Section in
of the Data Call-in Notice, 90-day progress reports are required for all studies.
If an asterisk appears in Item 5, EPA has attached information relevant to this
guideline reference number to the Requirements Status and Registrant's •
Response Form.
Item 6. This item identifies the code associated with the use pattern of the pesticide. A
brief description of each code follows:
A. Terrestrial food
B. Terrestrial feed
C, Terrestrial non-food
D. Aquatic food
E. Aquatic non-food outdoor
F. Aquatic non-food industrial
G. Aquatic non-food residential
H. Greenhouse food
I. Greenhouse non-food crop
J. Forestry
K. Residential
L. Indoor food
M. Indoor non-food
N. Indoor medical
O. Indoor residential
Item 7. This item identifies the code assigned to the substance that must be used for
testing. A brief description of each code follows.
EP End-Use Product
MP Manufacturing-Use Product
MP/TGAI Manufacturing-Use Product and Technical Grade Active
Ingredient
PAI Pure Active Ingredient
PAI/M Pure Active Ingredient and Metabolites
PAI/PAIRA Pure Active Ingredient or Pure Active Ingredient
Radio labelled
PAIRA Pure Active Ingredient RadiolabeUed
PAIRA/M Pure Active Ingredient RadiolabeUed and Metabolites
PAIRA/PM Pure Active Ingredient RadiolabeUed and Plant
Metabolites
TEP Typical End-Use Product
TEP _ * Typical End-Use Product, Percent Active Ingredient
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Specified
TEP/MET Typical Bid-Use Product and Metabolites
TEP/PAI/M Typical End-Use Product or Pure Active Ingredient and
Metabolites
TGAI/PAIRA Technical Grade Active Ingredient or Pure Active
Ingredient Radiolabelled
TGAI Technical Grade Active Ingredient
TGAI/TEP Technical Grade Active Ingredient or Typical
End-Use Product
TGAI/PAI Technical Grade Active Ingredient of Pure Active
Ingredient
MET Metabolites
IMP Impurities
DEGR Degradates
*See: guideline comment
Item 8. This item identifies the time frame allowed for submission of the study or
protocol identified in item 2. The time frame runs from the date of your
receipt of the Data Call-In Notice.
Item 9. Enter the appropriate Response Code or Codes to show how you intend to
comply with each data requirement. Brief descriptions of each code follow.
The Data Call-In Notice contains a fuller description of each of these options.
1. (Developing Data) I will conduct a new study and submit it within the
time frames specified in item 8 above. By indicating that I have chosen
this option, I certify that I will comply with all the requirements
pertaining to the conditions for submittal of this study as outlined in the
Data Call-in Notice and that I will provide the protocol and progress
reports required in item 5 above.
2. (Agreement to Cost Share) I have entered into an agreement with one
or more registrants to develop data jointly. By indicating that I have
chosen this option, I certify that I will comply with all the requirements
pertaining to sharing in the cost of developing data as outlined in the
Data Call-In Notice.
3. (Offer to Cost Share) I have made an offer to enter into an agreement
-with-ene-op more registrants to develop data jointly. I am submitting a
copy of the form "Certification of Offer to Cost Share in the
Development of Data" that describes this offer/agreement. By
indicating that I have chosen this option, I certify that I will comply
with all the requirements pertaining to making an' offer to share in the
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cost of developing data as outlined in the Data Call-In Notice.
4. (Submitting Existing Data) I am submitting an existing study that has
never before been submitted to EPA. By indicating that I have chosen
this option, I certify that this study meets all the requirements
pertaining to the conditions for submittal of existing data outlined in the
Data Call-In Notice and I have attached the needed supporting
information along with this response.
5. (Upgrading a Study) I am submitting or citing data to upgrade a study
that EPA has classified as partially acceptable and potentially
upgradeable. By indicating that I have chosen this option, I certify that
I have met all the requirements pertaining to the conditions for
submitting or citing existing data to upgrade a study described in the
Data Call-In Notice. I am indicating on attached correspondence the
Master Record Identification Number (MRID) that EPA has assigned to
the data that I am citing as well as the MRID of the study I am
attempting to upgrade.
6. (Citing a Study) I am citing an existing study that has been previously
classified by EPA as acceptable, core, core minimum, or a study that
has not yet been reviewed by the Agency. I am providing the Agency's
classification of the study.
7. (Deleting Uses) I am attaching an application for amendment to my
registration deleting the uses for which the data are required.
8. (Low Volume/Minor Use Waiver Request) I have read the statements
concerning low volume-minor use data waivers in the Data Call-in
Notice and I request a low-volume minor use waiver of the data
requirement. I am attaching a detailed justification to support this
waiver request including, among other things, all information required
to support the request. I understand that, unless modified by the
Agency in writing, the data requirement as stated in the Notice
governs.
9, (Request for Waiver of Data) I have read the statements concerning
data waivers other than low volume minor-use data waivers in the Data
Call-in Notice and I request a waiver of the data requirement, I am
—attacMng-am identification of the basis for^his waiver and a detailed
justification to support this waiver request. The justification includes,
among other things, all information required to support the request. I
understand that, unless modified by the Agency in writing, the data
requirement as stated in the Notice governs.
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Item 10. This item must be signed by an authorized representative of your company.
The person signing must include his/her title, and must initial and date all
other pages of this form.
Item 11. Biter the date of signature.
Item 12. Enter the name of the person EPA should contact with questions regarding
your response.
Item 13. Enter the phone number of your company contact.
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Attachment D
List of Registrants Sent This DCI
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APPENDIX G
Product Specific Data Call-In
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DATA CALL-IN NOTICE
Dear Sir or Madam;
This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment A of this Notice, the Data Call-in Chemical Status Sheet.
to submit certain product specific data as noted herein to the U.S. Environmental Protection
Agency (EPA, the Agency). These data are necessary to maintain the continued registration
of your product(s) containing this active ingredient. Within 90 days after you receive this
Notice you must respond as set forth in Section ffl below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its
Attachments A through G; or
2. Why you believe you are exempt from the requirements listed in this Notice
and in Attachment C, Requirements Status and Registrant's Response Form.
(see section ffl-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 ni-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will
comply with its requirements or should be exempt or excused from doing so, then the
registration of your product(s) subject to this Notice will be subject to suspension. We have
provided a list of all of your products subject to this Notice in Attachment B, Data Call-in
Response Form, as well as a list of all registrants who were sent this Notice (Attachment F).
The authority -for4his Notice is section 3(c)(2)(B) of the Federal Insecticide,
Fungicide and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B).
Collection of this information is authorized under the Paperwork Reduction Act by OMB
Approval No. 2070-0107 (expiration date 12-31-92).
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This Notice is divided into six sections and seven Attachments. The Notice itself
contains infoimation and instructions applicable to all Data Call-In Notices. The
Attachments contain specific chemical information and instructions. The six sections of the
Notice are:
Section I - Why You Are Receiving This Notice
Section n - Data Required By This Notice
Section IE- Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable
Adverse Effects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
A - Data Call-In Chemical Status Sheet
B - Product-Specific Data Call-In Response Form
C - Requirements Status and Registrant's Response Form
D - EPA Grouping of Bid-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
E - EPA Acceptance Criteria
F - List of Registrants Receiving This Notice
G - 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 H. DATA REQUIRED BY THIS NOTICE
n-A. DATA RF-QTITRRD
The product specific date required by this Notice are specified in Attachment C,
Requirements Status and Registrant's Response Form. Depending on the results of the studies
required in this Notice, additional testing may be required.
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H-B. SCHEDITLE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements specified in
Attachment C, Requirements Status and Registrant's Response Form, within the time frames
provided.
H-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: 703^87-4650).
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 CPU § 158.70). When using the
OECD protocols, they should be modified as appropriate so that the data generated by the study
will satisfy the requirements of 40 CFR § 158, Normally, the Agency will not extend deadlines
for complying with data requirements when the studies were not conducted in accordance with
acceptable standards. The OECD protocols are available from OECD, 1750 Pennsylvania
Avenue N.W., Washington, D.C. 20006.
All new studies and proposed protocols submitted in response to this Data Call-In Notice
must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
IJ-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-in does not in any way supersede or change
the requirements of any previous Data Call-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 m, COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
m-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 (his 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
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of NOIS due to failure to comply with this Notice are presented in Section IV-A and IV-B.
ffl-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 ffl-C. A discussion of options
relating to requests for data waivers is contained in Section ffl-D,
There are two forms that accompany this Notice of which, depending upon your
response, one or both must be used in your response to the Agency. These forms are the Data-
Call-in Response Form, and the Requirements Status and Registrant's Response Form,
Attachment B and Attachment C. The Data Call-In Response Form must be submitted as part of
every response to this Notice. In addition, one copy of the Requirements Status and
Registrant's Response Form must be submitted for each product listed on the Data Call-in
Response Form unless the voluntary cancellation option is selected or unless the product is
identical to another (refer to the instructions for completing the Data Call-in Response Form in
Attachment B). Please note that the company's authorized representative is required to sign the
first page of the Data Call-In Response Form and Requirements Status and Registrant's
Response Form (if this form is required) and initial any subsequent pages. The forms contain
separate detailed instructions on the response options. Do not alter the printed material. If you
have questions or need assistance in preparing your response, call or write the contact person(s)
identified in Attachment A.
1. Voluntary Cancellation - You may avoid the requirements of this Notice by requesting
voluntary cancellation of your product(s) containing the active ingredient that is the subject of
this Notice. If you wish to voluntarily cancel your product, you must submit a completed Data
Call-In Response Form, indicating your election of this option. Voluntary cancellation is item
number 5 on the Data Call-In Response Form. If you choose this option, this is the only form
that you are required to complete.
If you 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 Fjcisting 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 ffl-C of this Notice and comprise options 1 through 6 on the
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Requirements Status and Registrant's 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. Request for Product Specific Data Waivers. Waivers for product specific data are
discussed in Section ffl-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,
ffi-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-In Response Form that you agree to satisfy the
product specific data requirements (i.e. you select item number 7a or 7b), then you must select
one of the six options on the Requiremen|s Status and Registrant'gjtesponse Form related to
data production for each data requirement. Your option selection should be entered under item
number 9, "Registrant Response." The six options related to data production are the first six
options discussed under item 9 in the instructions for completing the Requirements Status and
Registrant's Response Form. These six options are listed immediately below with information
in parentheses to guide registrants to additional instructions provided in this Section. The
options are:
(1) I will generate and submit data within the specified time frame (Developing Data)
(2) I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an existing
study that has been submitted but not reviewed by the Agency (Citing an Existing
Study)
Option 1, Developing Data — If you choose to develop the required data it must be in
conformance with Agency deadlines and with other Agency requirements as referenced herein
and in the attachments. All data generated and submitted must comply with the Good
Laboratory Practice (GLP) rule (40 CFR Part 160), be conducted according to the Pesticide
Assessment Guidelines (PAG), and be in conformance with the requirements of PR Notice 86-5.
The time frames in the Requirements Status and Registrant's Response Form are the tune
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
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submitted by the deadline, each registrant is subject to receipt of a Notice of Intent to Suspend
the affected registration(s).
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If you cannot submit the data/reports to the Agency in the time required by this Notice
and intend to seek additional time to meet the requirements(s), you must submit a request to the
Agency which includes: (1) a detailed description of the expected difficulty and (2) a proposed
schedule including alternative dates for meeting such requirements on a step-by-step basis. You
must explain any technical or laboratory difficulties and provide documentation from the
laboratory performing the testing. While EPA is considering your request, the original deadline
remains. The Agency will respond to your request in writing. If EPA does not grant your
request, the original deadline remains. Normally, extensions can be requested only in cases of
extraordinary testing problems beyond the expectation or control of the registrant. Extensions
will not be given in submitting the 90-day responses. Extensions will not be considered if the
request for extension is not made in a timely fashion; in no event shall an extension request be
considered if it is submitted at or after the lapse of the subject deadline.
Option 2. Apeement to Share in Cost to Develop Data - Registrants may only choose
this option for acute toxicity data and certain efficacy data and only if EPA has indicated in the
attached data tables that your product and at least one other product are similar for purposes of
depending on the same data. If this is the case, data may be generated for just one of the
products in the group. The registration number of the product for which data will be submitted
must be noted in the agreement to cost share by the registrant selecting this option. If you
choose to enter into an agreement to share in the cost of producing the required data but will
not be submitting the data yourself, you must provide the name of the registrant who will be
submitting the data. You must also provide EPA with documentary evidence that an agreement
has been formed. Such evidence may be your letter offering to join in an agreement and the
other registrant's acceptance of your offer, or a written statement by the parties that an
agreement exists. The agreement to produce the data need not specify all of the terms of the
final arrangement between the parties or the mechanism to resolve the terms. Section 3(c)(2)(B)
provides that if the parties cannot resolve the terms of the agreement they may resolve their
differences through binding arbitration.
Option 3f 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 documentation to the
Agency proving -that ^ou-have made an offer to another registrant (who has an obligation to
submit data) to share in the burden of developing that data. You must also submit to the
Agency a completed EPA Form 8570-32, Certification of Offer to Cost Share in the
Development of Data, Attachment G. In addition, you must demonstrate that the other
registrant to whom the offer was made has not accepted your offer to enter into a cost sharing
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agreement by including a copy of your offer and proof of the other registrant's receipt of that
offer (such as a certified mail receipt). Your offer must, in addition to anything else, offer to
share in the burden of producing the data upon terms to be agreed or failing agreement to be
bound by binding arbitration as provided by FIFRA section 3(c)(2)(B)(iii) and must not qualify
this offer. The other registrant must also inform EPA of its election of an option to develop
and submit the data required by this Notice by submitting a Data Call-in Response Form and a
Requirements Status and Registrant's Response Form committing to develop and submit the data
required by this Notice.
In order for you to avoid suspension under this option, you may not withdraw your offer
to share in the burdens of developing the data. In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this Notice. If the other registrant
fails to develop the data or for some other reason is subject to suspension, your registration as
well as that of the other registrant will normally be subject to initiation of suspension
proceedings, unless you commit to submit, and do submit the required data in the specified time
frame. In such cases, the Agency generally will not grant a time extension for submitting the
data,
Option 4. Submitting an Existing Study — If you choose to submit an existing study in
response to this Notice, you must determine that the study satisfies the requirements imposed by
this Notice. You may only submit a study that has not been previously submitted to the Agency
or previously cited by anyone. Existing studies are studies which predate issuance of this
Notice. Do not use this option if you are submitting data to upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the
required date of submission. The Agency may determine at any time that a study is not valid
and needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly met:
a. You must certify at the time that the existing study is submitted that the raw data
and specimens from the study are available for audit and review and you must
identify where they are available. This must be done in accordance with the
requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR Part
160. As stated in 40 CFR 160.3(j) " 'raw data' means any laboratory worksheets,
records, memoranda, notes, or exact copies thereof, that are the result of original
observations and activities of a study and are necessary for the reconstruction and
-evaJuatioa-ef the-report of that study. In the event that exact transcripts of raw
data have been prepared (e.g., tapes which have been transcribed verbatim,
dated, and verified accurate by signature), the exact copy or exact transcript may
be substituted for the original source as raw data. 'Raw data' may include
photographs, microfilm or microfiche copies, computer printouts, magnetic
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media, including dictated observations, and recorded data from automated
instruments." The term "specimens", according to 40 CFR 16Q.3(k), means "any
material derived from a test system for examination or analysis."
b. Health and safety studies completed after May 1984 must also contain all GLP-
required quality assurance and quality control information, pursuant to the
requirements of 40 CFR Part 160. Registrants must also certify at the time of
submitting the existing study that such GLP information is available for post-May
1984 studies by including an appropriate statement on or attached to the study
signed by an authorized official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3
Technical Guidance and that the study has been conducted according to the
Pesticide Assessment Guidelines (PAG) or meets the purpose of the PAG (both
available from NTIS). A study not conducted according to the PAG may be
submitted to the Agency for consideration if the registrant beEeves 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 beleve 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 you know of a study pertaining to any requirement in this Notice which does not meet
the criteria outlined above but does contain factual information regarding unreasonable adverse
effects, you must notify the Agency of such a study. If such study is in the Agency's files,
you need only cite it along with the notification. If not in the Agency's files, you must submit a
summary and copies as required by PR Notice 86-5.
Option 5. Upgrading a Study — If a study has been classified as partially acceptable and
upgradeable, you may submit data to upgrade that study. The Agency will review the data
submitted and determine if the requirement is satisfied. If the Agency decides the requirement
is not satisfied, you may still be required to submit new data normally without any time
extension. Deficient, but upgradeable studies will normally be classified as supplemental.
However, it is important to note that not all studies classified as supplemental are upgradeable.
If you have questions regarding the classification of a study or whether a study may be
upgraded, call or write the contact person listed in Attachment A. If you submit data to
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upgrade an existing study you must satisfy or supply information to correct §U 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 eonformance 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 of data intended to
upgrade studies must be accompanied by a certification that you comply with each of those
criteria as well as a certification regarding protocol compliance with Agency requirements.
Option 6. Citing Existing Studies - If you choose to cite a study that has been
previously submitted to EPA, that study must have been previously classified by EPA as
acceptable or it must be a study which has not yet been reviewed by the Agency. Acceptable
toxicology studies generally will have been classified as "core-guideline" or "core minimum."
For all other disciplines the classification would be "acceptable." With respect to any studies
for which you wish to select this option you must provide the MRID number of the study you
are citing and, if the study has been reviewed by the Agency, you must provide the Agency's
classification of the study.
If you are citing a study of which you are not the original data submitter, you must
submit a completed copy of EPA Form 8570-31, Certification with Respect to Data
Compensation Requirements.
Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-inResponse Form and the
Requirements Status and Registrant's Response Form, as appropriate.
m-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. Y-eu 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.
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Waiver requests submitted without adequate supporting rationale will be denied and the original
due date will remain in force.
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IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice due
to failure by a registrant to comply with the requirements of this Data Call-In Notice, pursuant
to FJFRA section 3(c)(2)(B). Events which may be the basis for issuance of a Notice of Intent
to Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of
this Notice.
2. Failure to submit on the required schedule an acceptable proposed or final
protocol when such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on a study
as required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this
Notice.
5. Failure to take a required action or submit adequate information pertaining to any
option chosen to address the data requirements (e.g., any required action or
information pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task
Forces, failure to comply with the terms of an agreement or arbitration
concerning joint data development or failure to comply with any terms of a data
waiver).
6. Failure to submit supportable certifications as to the conditions of submitted
studies, as required by Section ffl-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost
of developing data and provided proof of the registrant's receipt of such offer or
failure of a registrant on whom you rely for a generic data exemption either to:
a. inform EPA of intent to develop and submit the data required by this
Notice -on a Data Gall-In Response Form and a Requirements Status and
Registrant's Response Form;
b. fulfill the commitment to develop and submit the data as required by this
Notice; or
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c. otherwise take appropriate steps to meet the requirements stated in this
Notice, unless you commit to submit and do submit the required data in
the specified time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at any
time following the issuance of this Notice.
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE '
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds
for suspension include, but are not limited to, failure to meet any of the following:
1. EPA requirements specified in the Data Call-In Notice or other documents
incorporated by reference (including, as applicable, EPA Pesticide Assessment
Guidelines, Data Reporting Guidelines, and GeneTox Health Effects Test Guidelines)
regarding the design, conduct, and reporting of required studies. Such requirements
include, but are not limited to, those relating to test material, test procedures, selection
of species, number of animals, sex and distribution of animals, dose and effect levels to
be tested or attained, duration of test, and, as applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the incorporation
of any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner of reporting,
the completeness of results, and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or included in this Notice or
contained in PR 86-5. All studies must be submitted in the form of a final report; a
preliminary report will not be considered to fulfill the submission requirement,
IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing
stocks of a pesticide product which has been suspended or cancelled if doing so would be
consistent with the purposes of the Act.
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding would generally not
be consistent with the Act's purposes. Accordingly, the Agency anticipates granting registrants
permission to sell, distribute, or use existing stocks of suspended product(s) only in exceptional
circumstances. If you believe such disposition of existing stocks of your product(s) which may
be suspended for failure to comply with this Notice should be permitted, you have the burden of
clearly demonstrating to EPA that granting such permission would be consistent with the Act.
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i
You must also explain why an "existing stocks" provision is necessary, including a statement of
the quantity of existing stocks and your estimate of the time required for their sale, distribution,
and use. Unless you meet this burden the Agency will not consider any request pertaining to
the continued sale, distribution, or use of your existing stocks after suspension.
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If you request a voluntary cancellation of your product(s) as a response to this Notice
and your product is in full compliance with all Agency requirements, you will have, under most
circumstances, one year from the date your 90 day response to this Notice is due, to sell,
distribute, or use existing stocks. Normally, the Agency will allow persons other than the
registrant such as independent distributors, retailers and end users to sell, distribute or use such
existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of
voluntarily cancelled products containing an active ingredient for which the Agency has
particular risk concerns will be determined on case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required by
this Notice will not result in the Agency granting any additional time to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was due unless you
demonstrate to the Agency that you are in full compliance with all Agency requirements,
including the requirements of this Notice. For example, if you decide to voluntarily cancel
your registration six months before a 3 year study is scheduled to be submitted, all progress
reports and other information necessary to establish that you have been conducting the study in
an acceptable and good faith manner must have been submitted to the Agency, before EPA will
consider granting an existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information
to the Agency. Registrants must notify the Agency of any factual information they have, from
whatever source, including but not limited to interim or preliminary results of studies, regarding
unreasonable adverse effects on man or the environment. This requirement continues as long as
the products are registered by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person(s) listed in Attachment A, 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 Status and Registrant's Response Form (Attachment B for generic data and
Attachment C for product specific data) and any other documents required by this Notice, and
should be-subntttted-to-ihe contactperson(s) identified in Attachment A. If the voluntary
cancellation or generic data exemption option is chosen, only the Data Call-In Response Form
need be submitted.
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The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in response to this
Notice.
Sincerely yours,
Peter P. Caulkins Ph.D., Acting Director
Special Review and
Reregistration Division
Attachments
B-
C-
D-
E-
F-
Data Call-In Chemical Status Sheet
Product-Specific Data Call-In Response Form
Requirements Status and Registrant's Response Form for the Product Specific
Data Call-in
EPA Grouping of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
EPA Acceptance Criteria
List of Registrants Receiving This Notice
Cost Share and Data Compensation Forms, and Product Specific Data Report
Form
125
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126
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i
Attachment A
Chemical Status Sheet
127
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128
*'«»,
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CEDARWOOD OIL DATA CALL[-]IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-in Notice because you have
product(s) containing cedarwood oil.
This Product Specific Data Call-In Chemical Status Sheet, contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the rercgistration of
cedarwood oil. This attachment is to be used in conjunction with (1) the Product Specific Data
Call-In Notice, (2) the Product Specific Data Call-In Response Form (Attachment B), (3) the
Requirements Status and Registrant's Form (Attachment C), (4) EPA's Grouping of End[-]Use
Products for Meeting Acute Toxicology Data Requirement (Attachment D), (5) the EPA
Acceptance Criteria (Attachment E), (6) a list of registrants receiving this DO (Attachment F)
and (7) the Cost Share and Data Compensation Forms in replying to this cedarwood oil Product
Specific Data Call[-]In (Attachment G). Instructions and guidance accompany each form.
The additional data requirements needed to complete the database for cedarwood oil are
contained in the Requirements Status and Registrant's Response. Attachment C. The Agency
has concluded that additional data on cedarwood oil 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 cedarwood oil products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of cedarwood oil, please
contact Ron Kendall at (703) 308-8068.
If you have any questions regarding the product specific data requirements and
procedures established by this Notice, please contact Frank Rubis (703) 308-8184. All
responses to this Notice for the Product Specific data requirements should be submitted to:
Frank Rubis, Product Manager, Team 81
Product Reregistration Branch
Special Review and Reregistration Division 7508W
-Office of-Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Cedarwood OU
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i
INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORM FOR
PRODUCT SPECIFIC DATA
Item 1-4.
Item 5.
Item 6.
Item 7a.
Already completed by EPA.
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 TV-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."
Item 7b. For each end use product (EUP) for which you wish to maintain registration, you
must agree to satisfy the data requirements by responding "yes." If you are
requesting a data waiver, answer "yes" here; in addition, on the "Requirements
Status and Registrant's Response" form under Item 9, you must respond with
Option 7 (Waiver Request) for each study for which you are requesting a waiver.
See Item 6 with regard to identical products and data exemptions.
Items 8-11. Self-explanatory,
NOTE: You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that your
product has already been transferred to another 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.
130
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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 transraittal 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 in the Notice, govern the conduct of the required studies.
Note that series 61 and 62 in product chemistry are now listed under 40 CFR
158.155 through 158.180, Subpart C,
Item 5. The study title associated with the guideline reference number is identified.
Item 6. The use pattern(s) of the pesticide associated with the product specific
requirements is (are) identified. For most product specific data requirements, all
use patterns are covered by the data requirements. In the case of efficacy data,
the required studies only pertain to products which have the use sites and/or pests
indicated.
Item 7. The substance to be tested is identified by EPA. For product specific data, the
product as formulated for sale and distribution is the test substance, except in rare
cases.
Item 8. The due date for submission of each study is identified. It is normally based on 8
months after issuance of 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 data requirements listed in this table. Fuller
descriptions of each option arc 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 Requirements"
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
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i
enough to another product to qualify for this option. I certify that another party
in the agreement is committing to submit or provide the required data; if the
required study is not submitted on time, my product may be subject to
suspension. 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).
3. I have made offers to share in the cost to develop data (Offers to Cost Share). I
understand that this option is available only for acute toxicity or certain efficacy
data and only if EPA indicates in an attachment to this Data Call-in Notice that
my product is similar enough to another product to qualify for this option. I am
submitting evidence that I have made an offer to another registrant (who has an
obligation to submit data) to share in the cost of that data. I am also submitting a
completed "Certification of Offer to Cost Share in the Development Data" form.
I am including a copy of my offer and proof of the other registrant's receipt of
that offer. I am identifying the party which is committing to submit or provide
the required data; if the required study is not submitted on time, my product may
be subject to suspension. I understand that other terms under Option 3 in the
Data Call-in Notice (Section M-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).
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 ffl-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).
5. 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 MRTD 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 m-C.l.)
apply. By the specified due date, I will also submit: (1) a completed
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"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).
6. By the specified due date, I will cite an existing study that the Agency has
classified as acceptable or an existing study that has been submitted but not
reviewed by the Agency (Citing an Existing Study). If I am citing another
registrant's study, I understand that this option is available only for acute toxicity
or certain efficacy data and only if the cited study was conducted on my product,
an identical product or a product which EPA has "grouped" with one or more
other products for purposes of depending on the same data. I may also choose
this option if I am citing my own data. In either case, I will provide the MRID
or Accession number(s) 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.
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Page 1 off
United States Environmental Protection Agency Form Approved
Washington, D. C. 20460 '• «. «,. wo-owr
DATA CALL-IN RESPONSE 2070-0057
Approval Expires 03-31-96
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this fora.
Use additional sheet (s) If necessary.
1. Company name and Address 2. Case f and Name 3. Date and Type of DC1
SAMPLE COMPANY 3150 Wood oils and gums PRODUCT SPECIFIC
NO STREET ADDRESS
NO CITY, XX 00000
«. fPA Product
Registration
NNNNNN-NNNNN
5, I wish to
cancel this
product regis-
tration volun-
tarily.
6. Generic Data
6a. I an claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed belou.
N.A.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
N.A.
7. Product Specific Data
7a. My product is a HUP and'
I agree to satisfy the HUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b. My product is an EUP and
i agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response.*
8. Certification 9. Datt
I certify that the statements made on this form and all attachments are true, accurate, and complete.
I acknowledge that any knowingly false or misleading statement my be punishable by fine, imprisonment
or both under applicable IBM.
Signature and Title of Company's Authorized Representative
10. Name of Company Contact 11. Phone Hunter
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Page 1 o£ 3
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully
Use odd it tonal sheet(s) If necessary.
1 . Company name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number
61-1
61-2 (a)
61-2 (b)
62-1
62s.2-:V^ ••'::••• : •
62-3
63 -;&-&'•••'•? "• ' '• v
63-3
63-4
63-5
63-6
63-7
Form Approved
OMB No. 2070-0107
2070-0057
Approval Expires 03-31-96
the attached instructions and supply the information requested on this form.
2. Case # and Name S. Date and Type of DC1
3150 Wood oils and gums PRODUCT SPECIFIC
ID# NNNNNN-RD-NNNN
EPA Reg. NO. NNNNNN-NNNNN
5. Study Title
Prod Cheat - tegular Ownieal
Product Identity I composition (1)
Descriptn starting materials, (1,2)
productn I formulatn
process
Discussion of formation of (1,3}
impurities
Preliminary analysis (1,6)
Certification of Unit* C1»5>
Analytical method (1)
Color
Physical state
Odor '• ' . ; '
Melting point (6)
Boiling point <7»
Density
10. Certification
|
0
C
0
L
Progress
Reports
1
2
3
6. Use
Pattern
ABCDIFGHIJKliiNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHljtiiMNO
ABCDEFGHIJKLMNO
ABOJEFGHIJKtiMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
7. Test
Substance .
MP/EP
MP/EP and T<3At
MP/EP and TGAI
MP/EP and TGAI
MP/EP ,
MP/EP
MP/BP and TGAI
MP/EP and TGAI
MP/EP and TGAI
TGAI
TGA1
MP/EP and TGAI
B. Time
Frame
8 mos.
8 tnos.
B mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 moa.
8 mos.
9. Registrant
Response
11. Date
1 certify that the statements made on this form and all attachments are true, accurate, and couple te.
1 acknowledge that any knowingly false or misleading statement my be punishable by fine, Imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
12. Name of Company Contact
13. Phone Hunfcer
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DRAFT COPY
Page 2 of 3
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully
Use additional sheet (s) if necessary.
1 . Company name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Nuflber
63-8
63-9
63-10
63-11
63-12
63-13 -:-
63-14
63-tSK'- •''•'
63-16
63-17
63-18
63-19
63-20
63-21
81-1
81-2
81-3
5. Study Title
Solubility
Vapor pressure
Dissociation constant
Octanol/water partition (8)
coefficient
pH (9)
Stability
Oxidizing or reducing action (10)
FlamMtmfty (11)
Explodability (12)
Storage stability
Viscosity (13)
MisclbiUty (14)
Corrosion characteristics
Dielectric breakdown voltag* (15)
Acute Toxic - Regular ctwdcal
the attached instructions and supply the
2. Case * and Name
information requested
3150 Wood oils and gums
EPA Reg. No. NNNNNN-NNNNN
Acute oral toxieity-rat (1,36,3?)
Acute dermal (1,2,37)
toxl city- rabbit/rat
Acute inhalation toxicfty-rat (3)
Initial to indicate certification as to information on this page
(full text of certification is on page one).
1
I
§
L
Progress
Reports
1
2
3
6. Use
Pattern
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDBFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
7. Test
Form Approved
OHB No. 2070-010?
2070-0057
Approval Expires 03-3 1 -96
on this form.
3. Date and Type of DC1
PRODUCT SPECIFIC
ID# NNNNNN-RD-NNNN
Substance
TGAI/PAI
TGAI/PAI
TGAI/PAI
PAI
MP/EP
MP/BP
MP/EP
MP/BP
MP/EP
MP/BP
MP/EP
MP/EP
MP/EP
MP/BP
MP/BP
MP/EP
MP/EP
and TGAI
and TGAI
and TGAI
and TGAI
8. Time
Frame
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mOS.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
9. Registrant
Response
Date
136
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Page 3 of 3
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in Ink. Please read carefully
Use additional sheet(s) if necessary.
1. Company name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requl rewent
Hunter
81-4
81-5
81-6
95-11
5. Study Title
Primary eyt irritation-rabbit 52)
Primary dermal Irritation (1,2)
Dermal senslttiatfon (4}
^fftcaof,-,.lnM)rfcbr*tfI.cantriDi, taenta
Pratise* fjstjpeflji
Laboratory efficacy (1,3,4)
•valuation
the attached instructions and supply the
information requested
2. Case f and Nam
3150 Wood oils and gums
EPA Reg. No. NNNNNN-NNNNN
L
Progress
Reports
1
2
3
6, Use
Pattern
ABCDIFGHIJKtiMNO
ABCDEFGHIJKIjMNO
ABCDEPGHXJKIliNO
KLM O
Initial to Indicate certification as to information on this page
(full text of certification is on page one).
Form Approved
OMB No. 2070-0107
EQ7Q-OOS7
Approval Expires 03-31-94
on this form.
3. Date and Type of OC1
PRODUCT SPECIFIC
ID* NNNNNN-RD-NNNN
7. Test
Substance
MP/EP
MP/EP
MP/BP
EP
8. Time
Frame
8 mOS.
8 mos.
8 mos,
8 mos.
9. Registrant
Response
Date
137
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DRAFT COPY . • Page 1 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 3150 Wood oils and gums
Cis., *-rt; Cf> = end-use product; provided formulators purchase their active Ingredient(s) from a registered source, they need not submit or cite
..Jin V*i tbin«ii* to the purchased product. [NOTE: If a product is a 100 percent repackage of another registered product that Is purchased, and any use for the product doe*
not differ from those of the purchased and registered source, users are not subject to any dat* requirements identified In the tables.]; Tip * typical end-use product;
TGA1 « technical grade of the active ingredient; PAI = "pure" active ingredient; PAIRA = "pure" active ingredient, radl.labeled.
Use Categories Key;
A - Terrestrial food crop B - Terrestrial food feed crop C - Terrestrial nonfood crop D - Aquatic food crop E - Aquatic nonfood outdoor
F • Aquatic nonfood Industrial G - Aquatic nonfood residential H - Greenhouse food crop I * Greenhouse nonfood crop J - Forestry
K - Residential outdoor L - Indoor food M - Indoor nonfood N - Indoor Medical 0 - Indoor residential
Footnotes: [The following notes are referenced in colum two {5. Study Title) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
Prod Chen - Regular Chemical
1 Requirements pertaining to product identity, composition, analysis, and certification of Ingredients are detailed further in the following sections: *158.155 far
product identity and composition (61-1); "158.160, 158,162, and 158.165 for description of starting materials and manufacturing process (61-2); *158.167 for
discussion of formation of Impurities (61-3); *158.1fO for preliminary analysis (62-1); *158.175 for certification of limits (62-Z); and *158.180 for tnforeanent
analytical methods (6Z-3).
2 A schematic diagram and/or brief description of the production process Hill suffice If the pesticide Is not already under full ical* production and an experimental
use permit Is being sought.
3 If the pesticide is not already under full scale production and an experimental use permit Is sought, a discussion of unintentional Ingredients shall be submitted to
the extent this Information is available.
4 To support registration of an HP or EP, whether produced by an integrated system or not, the technical grade of Active Ingredient must be analyzed. If the technical
grade of Active Ingredient cannot be Isolated, a statement of composition of the practical equivalent of the technical grade of Active Ingredient must be submitted.
Data on EPs or MPs will be required on a case-by-case basis,
S Certified limits are not required for inert ingredients in products proposed for experimental use.
'6 Required If technical chemical is solid at room temperature.
7 Required If technical chemical Is liquid at room temperature.
8 Required If technical chemical is organic and non-polar,
9 Required If test substances are dispersibte with water.
10 Required If product contains an oxldiiirtg or reducing agent.
11 Required If product contains combustible liquids.
12 Required if product Is potentially explosive.
13 Required If product is a liquid.
14 Required if product is an emulsiffable liquid and is to be diluted with petroleum solvents.
15 Required If end-use product is liquid and is to be used around electrical equipment.
Acute Toxic - Regular Cheaical
1 Not required If test material is a gas or highly volatile.
2 Not required if test material is corrosive to skin or has pH less than 2 or greater than 11.S; such a product will be classified as Toxlclty Category I on the basis
of potential eye and dermal irritation effects.
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DRAFT-COPY Page 2 Of 2
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 3150 Wood oils and gums
;vv || I,, I,, - - -LIU.... ,,,| uuuu •:•:•::::::,, -VL. vvv;;;;^ * - vv;;;;;^ ..-I - vv;;;;;^ - nnnr .-J.-.-.V.1....... -1- "'' ITITUT TU "-- vv;;;;-..J H1JL
Footnotes (cont.):
3 Required if the product consists of, or under conditions of use uill result in, an Inhalable material (e. g., gas, volatile substances, or aerosol/particulate).
<• -Tfiired unless repeated dermal exposure does not occur under conditions of use.
•' •• tir.i (acute, subchronic, and/or chronic) is required for organophospates, and may be required for other choIinesterase inhibitors and other pesticide
ii,. *..ed a , t»ntial to adversely affect the visual system. Registrant* should consult with the agency for development of protocols and methodology
;•;.-' - \ud:es.
. _^.,.., 01 i,ie EP dilution Is required if it can be reasonably anticipated that the results of such testing may meet the criteria for restriction to use by certified
applicators specified in 40 CFR 152.170
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i
140
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Attachment D
EPA Grouping of End-Use Products for Meeting Data Requirements for
Reregistration
141
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EPA'S DECISION ON BATCHING PRODUCTS CONTAINING CEDAR WOOD OIL FOR PURPOSES
OF MEETING ACUTE TOXICITY DATA REQUIREMENTS FOR REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the acute toxicity
data requirements for reregistration of products containing the active ingredient cedar wood oil, the Agency
considered batching products. This process involves grouping similar products for purposes of acute
toxicity. Factors considered in the sorting process include each product's active and inert ingredients
(identity, percent composition and biological activity), type of formulation (e.g., emulsifiable concentrate,
aerosol, wettable powder, granular, etc.), and labeling (e.g., signal word, use classification, precautionary
labeling, etc.). Note that the Agency is not describing batched products as "substantially similar" since
some products within a batch may not be considered chemically similar or have identical use patterns.
Batching has been accomplished using the information described above as available. Acute toxicity
data on individual products has frequently been found to be incomplete. Notwithstanding the batching
process, the Agency reserves the right to require, at any time, acute toxicity data for an individual product
should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or cite a single
battery of six acute lexicological studies to represent all the products within that batch. It is the registrants'
option to participate in the process with all other registrants, only some of the other registrants, or only
their own products within a batch, or to generate all the required acute toxicological studies for each of
their own products. If a registrant chooses to rely upon previously submitted acute toxicity data, he/she
may do so provided that the data base is complete and valid by today's standards (see acceptance criteria
attached), the formulation tested is considered by EPA to be similar for acute toxicity, and the formulation
has not been significantly altered since submission and acceptance of the acute toxicity data. Regardless of
whether new data is generated or existing data is cited, the registrant must clearly identify the material
tested by its EPA registration number.
In deciding how to meet the product specific data requirements, registrants must follow the
directions given in the Data Call-in Notice and its attachments appended to the RED. The DCI Notice
contains two response forms which are to be completed and submitted to the Agency within 90 days of
receipt. The first form, "Data Call-In Response", asks whether the registrant will meet the data
requirements for each product. The second form, "Requirements Status and Registrant's Response", lists
the product specific data required for each product, including the standard six acute toxicity tests. A
registrant who wishes to participate in a batch must decide whether he/she will provide the data or depend
on someone else to do so. If a registrant supplies the data to support a batch of products, he/she must
select one of the following options: Developing Data (Option 1), Submitting an Existing Study (Option 4),
Upgrading an Existing Study (Option 5), or Citing an Existing Study (Option 6). If a registrant depends on
another's data, he/she-must-choose among: Cost Sharing (Option 2), Offers to Cost Share (Option 3) or
Citing an Existing Study (Option 6). If a registrant does not want to participate in a batch, the choices are
Options 1, 4, 5 or 6. However, a registrant should know that choosing not to participate in a batch does
not preclude other registrants in the batch form citing his/her studies and offering to cost share (Option 3)
those studies.
142
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Table I lists the products of Batch 1.
Table I.
Batch No.
1
EPA Reg. No.
65555-1
65813-1
66211-1
% of Cedar Wood
Oil
5,17
4.40
4.40
Formulation Type
block
block
block
Table n lists the products which could not be batched. These products were not considered similar
for purposes of acute toxicity.
The registrants of these products are responsible for meeting the acute toxicity data requirements specified
in the data matrix for end-use products.
Table H.
EPA Reg. No.
63380-1
42443-1
% of Cedar Wood Oil & other
Active Ingredients
0.48
0.50
Oil of Pennyroyal 2.00
Oil of Eucalyptus 1.00
Oil of Citronella 0.50
Oil of Rue 0.12
Formulation Type
aerosol
collar
143
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144
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i
ATTACHMENT E
EPA ACCEPTANCE CRITERIA
145
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146
*««
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I
SUBDIVISION D
Guideline Study Title
Series 61 Product Identity and Composition
Series 62 Analysis and Certification of Product Ingredients
Series 63 Physical and Chemical Characteristics
147
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I
148
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til Product Identity and Composition
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Name of technical material tested (include product name and trade name, if appropriate).
2. Name, nominal concentration, and certified limits (upper and lower) for each active ingredient and each
intentionally-added inert ingredient.
3. Name and upper certified limit for each impurity or each group of impurities present at >. 0.1 % by weight
and for certain lexicologically significant impurities (e.g., dioxins, nitrosamines) present at
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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).
150
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i
62 Analysis and Certification of Product Ingredients
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered. Use a table to present
the information in items 6, 7, and 8.
Does your study meet the following acceptance criteria?
1. Five or more representative samples (batches in case of batch process) analyzed for
each active ingredient and all impurities present at > 0,1%.
2, Degree of accountability or closure _>. ca 98%.
3. Analyses conducted for certain trace toxic impurities at lower than 0.1% (examples,
nitrosamines in the case of products containing dinitroanilines or containing secondary
or tertiary amines/alkanolamines plus nitrites; polyhalogenated dibenzodioxins and
dibenzofurans). [Note that in the case of nitrosamines both fresh and stored samples
must be analyzed.].
4. Complete and detailed description of each step in analytical method used to analyze
above samples.
5. Statement of precision and accuracy of analytical method used to analyze above
samples.
6. Identities and quantities (including mean and standard deviation) provided for each
analyzed ingredient.
1. Upper and lower certified limits proposed for each active ingredient and intentionally
added inert along with explanation of how the limits were determined.
8. Upper certified limit proposed for each impurity present at >_ 0.1 % and for certain
lexicologically significant impurities at < 0.1 % along with explanation of how limit
determined.
9.; Analytical methods to verify certified limits of each active ingredient and impurities
(latter not required if exempt from requirement of tolerance or if generally recognized
as safe by FDA) are fully described.
10. Analytical methods (as discussed in #9) to verify certified limits validated as to their
precision and accuracy.
151
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152
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63 Physical and Chemical Characteristics
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered.
Does your study meet the following acceptance criteria?
63-2 Color
Verbal description of coloration (or lack of it)
Any intentional coloration also reported in terms of Munsell color system
63-3 Physical State
Verbal description of physical state provided using terms such as "solid, granular, volatile liquid"
Based on visual inspection at about 20-25° C
63-4 Odor
Verbal description of odor (or lack of it) using terms such as "garlic-like, characteristic of aromatic
compounds"
Observed at room temperature
63-5 Melting Point
Reported in °C
Any observed decomposition reported
63-6 Boiling Point
Reported in °C
Pressure under which B.P. measured reported
Any observed decomposition reported
63-7 Density, Bulk Density, Specific Gravity
Measured at about 20-25° C
Density of technical grade active ingredient reported in g/ml or the specific gravity of liquids reported with
reference to water at 20° C. [Note: Bulk density of registered products may be reported in Ibs/ft3 or
Ibs/gallon.]
63-8 Solubility
Determined in distilled water and representative polar and non-polar solvents, including those used in
formulations and analytical methods for the pesticide
Measured at about 20-25° C
Reported in g/100 ml (other units like ppm acceptable if sparingly soluble)
153
*'«».
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63-9 Vapor Pressure
Measured at 25° C (or calculated by extrapolation from measurements made at higher temperature if
pressure too low to measure at 25° C)
Experimental procedure described
Reported in mm Hg (ton) or other conventional units
63-10 Dissociation Constant
Experimental method described
Temperature of measurement specified (preferably about
20-25 °C)
63-11 Octanol/water Partition Coefficient
Measured at about 20-25° C
Experimentally determined and description of procedure provided (preferred method-45 Fed. Register
77350)
Data supporting reported value provided
63-12 pH
Measured at about 20-25° C
Measured following dilution or dispersion in distilled water
63-13 Stability
Sensitivity to metal ions and metal determined
Stability at normal and elevated temperatures
Sensitivity to sunlight determined
154
iff*
*'««,-
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I
SUBDIVISION F
Guideline Study Title
81-1 Acute Oral Toxicity in the Rat
81-2 Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
81-3 Acute Inhalation Toxicity in the Rat
81-4 Primary Eye Irritation in the Rabbit
81-5 Primary Dermal Irritation Study
81-6 Dermal Sensitization in the Guinea Pig
155
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15.6
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i
81-1 Acute Oral Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. At least 5 young adult rats/sex/group.
3. Dosing, single oral may be administered over 24 hrs.
4.* Vehicle control if other than water.
5. Doses tested, sufficient to deteimine a toxicity category or a limit dose (5000 mg/kg).
6. Individual observations at least once a day.
7. Observation period to last at least 14 days, or until all test animals appear normal whichever
is longer.
8, Individual daily observations,
9. Individual body weights.
10. Gross necropsy on all animals.
Cntent nurked with an * *re supplemental and may not be required for every ttudy.
157
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81-2 Acute Dermal toxicity in the Rat, Rabbit or Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc),
2. At least 5 animals/sex/group. "
3.* Rats 200-300 gin, rabbits 2,0-3.0 kg or guinea pigs 350-450 gin.
4. Dosing, single dermal.
5. Dosing duration at least 24 hours.
6.* Vehicle control, only if toxicity of vehicle is unknown.
7. Doses tested, sufficient to determine a toxicity category or a limit dose (2000 mg/kg).
8. Application site clipped or shaved at least 24 hours before dosing.
9, Application site at least 10% of body surface area.
10. Application site covered with a porous nonirritating cover to retain test material and t o
prevent ingestion.
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
Criteri* marked with «n * are supplemental and m«y not be required for evety Mudy.
158
*'<£,
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81-3 Acute Inhalation Toxicity in the Rat
ACCEPTANCE C1TTER1A
Does your study meet the following acceptance criteria?
1. ,_ Identify material tested (technical, end-use product, etc).
2. ,_ Product is a gas, a solid which may produce a significant vapor hazard based on toxicity and expected
use or contains particles of inhalable size for man (aerodynamic diameter 15 /un or less).
3. At least 5 young adult rats/sex/group.
4, Dosing, at least 4 hours by inhalation.
5. Chamber air flow dynamic, at least 10 air changes/hour, at least 19% oxygen content.
6. Chamber temperature, 22° C (±2°), relative humidity 40-60%.
7. Monitor rate of air flow.
8. Monitor actual concentrations of test material in breathing zone.
9. Monitor aerodynamic particle size for aerosols.
10. Doses tested, sufficient to determine a toxicity category or a limit dose (5 mg/L actual concentration
of respirable substance).
11, Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
159
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i
81-4 Primarj Eye Irritation in the Rabbit
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive, causes severe dermal irritation or has a pH of ._11.5.
3. 6 adult rabbits.
4. Dosing, instillation into the conjunctiva! sac of one eye per animal.
5. Dose, 0.1 ml if a liquid; 0,1 ml or not more than 100 mg if a solid, paste or paniculate substance.
6. SoEd or granular test material ground to a fine dust.
7. Eyes not washed for at least 24 hours.
8. Eyes examined and graded for irritation before dosing and at 1, 24, 48 and 72 hr, then daily until eyes
are normal or 21 days (whichever is shorter),
9.* Individual daily observations.
Catena marked with in * ire supplement*! «nd may not be required for every study.
160
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81-5 Primary Dermal Irritation Study
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive or has a pH of 11,5.
3. 6 adult animals.
4. Dosing, single dermal.
5. Dosing duration 4 hours.
6. Application site shaved or clipped at least 24 hours prior to dosing.
7. Application site approximately 6 cm2,
8. Application site covered with a gauze patch held in place with noninitating tape.
9. Material removed, washed with water, without trauma to application site.
10. Application site examined and graded for irritation at 1, 24, 48 and 72 hr, then daily until normal or
14 days (whichever is shorter).
11.* Individual daily observations.
Criteria marked with in * are njpplemental and may not be required for every itudy.
161
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81-6 Dermal Sensitization in the Guinea Fig
ACCEPTANCE CRITERIA
Does your study meet the foEowing acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive or has a pH of <2 or > 11.5.
3. .One of the following methods is utilized:
Freund's complete adjuvant test
Guinea pig maximization test
Split adjuvant technique
Buehler test
Open epicutaneous test
Mauer optimization test
Footpad technique in guinea pig.
4. Complete description of test.
5.* Reference for test.
6. Test followed essentially as described in reference document.
7. Positive control included (may provide historical data conducted within the last 6 months).
Criteria marked with in * are supplement*! and nay not be required for every itudy,
162
*"<».
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i
ATTACHMENTF
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN
NOTICE
163
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164
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I
ATTACHMENT G
COST SHARE AND DATA COMPENSATION FORMS
165
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166
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r/EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OIIS No. 20704101
Approval Expire* 12-31-92
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 eoBedfen 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 Polcy
Branch, PM-223, U.S. Environmental Protection Agency, 401 M St.. S.W., Washington, DC 20460; and to the Office
«f Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Please fill in blanks below.
Company Nam*
Company Number
Chemical Nam*
IPA Chemical Number
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(»)
Oat* 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
Nam* and
el Company's Autf,
orized Representative
Oat*
i
Title (Pl*aae Type or Print)
EPA Form 1570-32
167
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168
*'«*
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&EPA
United Slates Environmental Protection Agency
Washington, D.C 24460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
OMB N*. l»7»-fll«
Appr***l tlplrw I3.3l.f2
Public nyoroagbcnien far this ecllecn'ca of into
reviewing instructions, searching existing data sources, gaihering inl nutintaining the daa needed, and compleong and
review -ing the coBfctiwi of information. Send comments regarding the burden <"-Bf|*'yt* or any other aspect of this collection of
infor Cation, including suggestions for reducing this burden, D Chief. Information Policy Branch, PM-223, UJ.
En vi oomenol Pnxecricc Agency, 401M, St. S.W., Washington, D£. 20460; and to the Office of Management and Budget,
Pap«al3 below.
Company Nj
Cbemical Name
. EPA Chrmifal Nonber
ICenxfyibat
1. For each study died In
icregjsmion pndff tfae Federal
, Fungicide and Rodennlcide Act (FIFRA) thai is
an exclusive use study, I an the original data M^mJffT. or I have ftfroinfd Aft wrioen r*TTBiPHon of r*w* original **** TnN"fn'^' to
cite that study.
submitter, or I lave obtained the wrinea pennisaion of the original data lahminef.or I hawmotifiedii wnoat ibecooqa»7Qe»)
that sabcmneddaa I have died and have offered ttt (a) p«y >*«ipgn
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