United States Prevention, Pesticides EPA 738-R-94-034
Environmental Protection And Toxic Substances September 1994
Agency (7508W)
&EPA Reregistration
Eligibility Decision (RED)
Limonene
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregistration eligibility review and decisions on the pesticide chemical case Limonene which
includes the active ingredient limonene.
The enclosed Reregistration Eligibility Decision (RED) contains the Agency's
evaluation of the data base of this [these] chemical [s], its conclusions of the potential human
health and environmental risks of the current product uses, and its decisions and conditions
under which these uses and products will be eligible for reregistration. The RED includes the
data and labeling requirements for products for reregistration. It may also include
requirements for additional data (generic) on the active ingredient(s) to confirm the risk
assessments.
To assist you with a proper response, read the enclosed document entitled "Summary
of Instructions for Responding to the RED". This summary also refers to other enclosed
documents which include further instructions. You must follow all instructions and submit
complete and timely responses. The first set of required responses are due 90 days from
the date of this letter. The second set of required responses are due 8 months from the
date of this letter. Complete and timely responses will avoid the Agency taking the
enforcement action of suspension against your products.
If you have questions on the product specific data requirements or wish to meet with
the Agency, please contact the Special Review and Reregistration Division representative
Franklin Gee at (703) 308-8008. Address any questions on required generic data to the
Special Review and Reregistration Division representative Emily Mitchell at (703) 308-8583.
Sincerely yours,
Louis P. True, Jr., Director
Special Review and
Reregistration Division
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1. DATA CALL-IN (PCI) OR "90-DAY RESPONSE" If generic data are required for
reregistration, a DCI letter will be enclosed describing such data. If product specific data
are required, another DCI letter will be enclosed listing such requirements. If both generic
and product specific data are required, a combined Generic and Product Specific letter will
be enclosed describing such data. Complete the two response forms provided with each DCI
letter (or four forms for the combined) by following the instructions provided. You must
submit the response forms for each product and for each DCI within 90 days of the date
of this letter (RED issuance date); otherwise, your product may be suspended.
2. TIME EXTENSIONS AND DATA WAIVER REQUESTS No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for data waivers must be submitted as part of the
90-day response. Requests for time extensions should be submitted in the 90-day response,
but certainly no later than the 8-month response date. All data waiver and time extension
requests must be accompanied by a full justification. All waivers and time extensions must be
granted by EPA in order to go into effect.
3. APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE" You must
submit the following items for each product within eight months of the date of this letter
(RED issuance date).
a. Application for Reregistration (EPA Form 8570-1). Use only an original
application form. Mark it "Application for Reregistration." Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in item 5.
b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
changes, or labeling changes not related to reregistration) separately. You may delete uses
which the RED says are ineligible for reregistration. For further labeling guidance, refer to
the labeling section of the EPA publication " General Information on Applying for Registration
in the U.S., Second Edition, August 1992" (available from the National Technical Information
Service, publication #PB92-221811; telephone number 703-487-4650).
c. Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA
identifier (MRID) numbers. Before citing these studies, you must make sure that they meet
the Agency's acceptance criteria (attached to the DCI).
d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
concentration. You have two options for submitting a CSF: (1) accept the standard certified
limits (see 40 CFR §158.175) or (2) provide certified limits that are supported by the analysis
of five batches. If you choose the second option, you must submit or cite the data for the five
batches along with a certification statement as described in 40 CFR §158.175(e). A copy of
the CSF is enclosed; follow the instructions on its back.
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e. Certification With Respect to Data Compensation Requirements. Complete and
sign EPA form 8570-31 for each product.
4. COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5. WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
By U.S. Mail:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVIEWS—EPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections. EPA will try to respond to data
waiver and time extension requests within 60 days. EPA will also try to respond to all 8-
month submissions with a final reregistration determination within 14 months after the RED
has been issued.
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REREGISTRATION ELIGIBILITY DECISION
LIMONENE
LISTC
CASE 3083
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
LIMONENE REREGISTRATION ELIGIBILITY DECISION TEAM i
EXECUTIVE SUMMARY vi
I. INTRODUCTION 1
II. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 3
C. Estimated Usage of Pesticide 4
D. Regulatory History 6
III. SCIENCE ASSESSMENT 6
A. Physical Chemistry Assessment 6
B. Human Health and Environmental Assessment 7
1. Toxicology Assessment 8
a. Acute Toxicity 8
b. Subchronic Toxicity 8
c. Chronic toxicity 9
d. Mutagenicity and Carcinogenicity 9
e. Developmental Toxicity 9
f. Other Toxic Endpoints 10
2. Exposure Assessment 10
a. Occupational and Residential 10
3. Risk Assessment 11
a. Occupational and Residential 11
C. Environmental Assessment 11
1. Environmental Fate 11
a. Environmental Chemistry, Fate and Transport 11
b. Environmental Fate Assessment 11
2. Ecological Effects 12
a. Ecological Effects Data 12
(1) Terrestrial Data 12
(2) Aquatic Data 14
b. Ecological Effects Risk Assessment 16
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 20
A. Determination of Eligibility 20
1. Eligibility Decision 20
2. Eligible and Ineligible Uses 21
B. Regulatory Position 21
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C. Tolerance Reassessment 21
V. ACTIONS REQUIRED BY REGISTRANTS 22
A. Manufacturing-Use Products 22
1. Additional Generic Data Requirements 22
2. Labeling Requirements for Manufacturing-Use Products 22
B. End-Use Products 23
1. Additional Product-Specific Data Requirements 23
2. Labeling Requirements for End-Use Products 23
3. Additional Label Requirements 24
4. Existing Stocks 24
VI. APPENDICES 27
APPENDIX A. Table of Use Patterns Subject to Reregistration 29
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 37
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of Limonene 51
APPENDIX D. List of Available Related Documents 85
APPENDIX E 89
PR Notice 86-5 91
PR Notice 91-2 109
APPENDIX F. Combined Generic and Product Specific Data Call-In 115
Attachment 1. Chemical Status Sheets 135
Attachment 2. Combined Generic and Product Specific Data Call-in
Response Forms (Form A inserts) Plus Instructions 139
Attachment 3. Generic and Product Specific Requirement Status and
Registrant's Response Forms (Form B inserts) and Instructions
145
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 151
Attachment 5. EPA Acceptance Criteria 155
Attachment 6. List of All Registrants Sent This Data Call-in (insert) Notice
169
Attachment 7. Cost Share Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 171
APPENDIX G. FACT SHEET 181
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LIMONENE REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
GABE PATRICK
ALAN HALVORSON
Environmental Fate and Effects Division
WILLIAM ERICKSON
LARRY LIU
KATHY MONK
Health Effects Division
LINNEA HANSEN
ARLIENE AIKENS
Registration Division
DAN PEACOCK
DARIA MILLS
SAMI MALAK
IAN BLACKWELL
Special Review and Reregistration Division
EMILY MITCHELL
BARBARA BRISCOE
Office of Compliance Monitoring:
PHYLLIS FLAHERTY
Biological Analysis Branch
Economic Analysis Branch
Ecological Effects Branch
Environmental Fate and Groundwater Branch
Science Analysis and Coordination Staff
Toxicology Branch I
Chemical Coordination Branch
Insecticide-Rodenticide Branch
Insecticide-Rodenticide Branch
Registration Support Branch
Registration Support Branch
Policy, Planning and Operations Branch
Policy, Planning and Operations Branch
Pesticides Enforcement Policy Branch
Office of General Counsel:
KEVIN LEE
Pesticides Branch
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11
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GLOSSARY OF TERMS AND ABBREVIATIONS
AE Acid equivalent
a.i. Active Ingredient
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CSF Confidential Statement of Formula
DRES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (DWEL) The DWEL represents a medium
specific (i.e. drinking water) lifetime exposure at which adverse, non carcinogenic
health effects are not anticipated to occur.
EEC Estimated Environmental Concentration. The estimated pesticide concentration in
an environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
GLC Gas Liquid Chromatography
GRAS Generally Recognized As Safe as designated by FDA
HA Health Advisory (HA) The HA values are used as informal guidance to
municipalities and other organizations when emergency spills or contamination
situations occur.
HOT Highest Dose Tested
LC50 Median Lethal Concentration. A statistically derived concentration of a substance
that can be expected to cause death in 50% of test animals. It is usually expressed
in
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GLOSSARY OF TERMS AND ABBREVIATIONS
LD
50
LDlo
LEL
LOG
LOEL
MCLG
MP
MPI
MOE
MRID
N/A
NPDES
NOEL
OPP
PADI
PAM
PPE
as the weight of substance per weight or volume of water, air or feed, e.g., mg/1,
mg/kg or ppm.
Median Lethal Dose. A statistically derived single dose that can be expected to
cause death in 50% of the test animals when administered by the route indicated
(oral, dermal, inhalation). It is expressed as a weight of substance per unit weight
of animal, e.g., mg/kg.
Lethal Dose-low. Lowest Dose at which lethality occurs
Lowest Effect Level
Level of Concern
Lowest Observed Effect Level
Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency
to regulate contaminants in drinking water under the Safe Drinking Water Act.
Manufacturing-Use Product
Maximum Permissible Intake
Margin Of Exposure
Master Record Identification (number). EPA's system of recording and tracking
studies submitted.
Not Applicable
National Pollutant Discharge Elimination System
No Observed Effect Level
Office of Pesticide Programs
Provisional Acceptable Daily Intake
Pesticide Analytical Method
Personal Protective Equipment
IV
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GLOSSARY OF TERMS AND ABBREVIATIONS
ppm Parts Per Million
PRN Pesticide Registration Notice
Q*! The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk
Model
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RS Registration Standard
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TC Toxic Concentration. The concentration at which a substance produces a toxic
effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TMRC Theoretical Maximum Residue Contribution
TLC Thin Layer Chromatography
WPS Worker Protection Standard
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EXECUTIVE SUMMARY
The Agency has determined that the uses of limonene as currently registered will not
cause unreasonable risk to humans or the environment and these uses are eligible for
reregistration. The Agency is requiring additional confirmatory data for the 90-Day Dermal
Toxicity Study.
Before reregistering the products containing limonene, the Agency is requiring that
product specific data, revised Confidential Statements of Formula (CSF) and revised labeling
be submitted within eight months of the issuance of this document. These data include product
chemistry for each registration and acute toxicity testing. After reviewing these data and any
revised labels and finding them acceptable in accordance with Section 3(c)(5) of FIFRA, the
Agency will reregister a product. Those products which contain other active ingredients will
be eligible for reregistration only when the other active ingredients are determined to be
eligible for reregistration.
Limonene is a naturally occurring chemical which is used in many food products, for
its characteristic lemon-like flavor and odor. The Food and Drug Administration lists
limonene as a Generally Recognized as Safe (GRAS) food additive/flavoring and fragrance
additive (soap,perfume).
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 limonene. The document consists of six sections. Section I is the
introduction. Section II describes limonene, its uses, data requirements and regulatory
history. Section III discusses the human health and environmental assessment based on the data
available to the Agency. Section IV presents the reregistration decision for limonene. Section
V discusses the reregistration requirements for limonene. Finally, Section VI is the
Appendices which support this Reregistration Eligibility Decision. Additional details
concerning the Agency's review of applicable data are available on request.
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II. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility
Document:
€ Common Name: Limonene
€ Chemical Name: l-methyl-4-(l-methylethenyl)cyclohexene
€ CAS Registry Number: 138863
€ OPP Chemical Code: 079701
€ Empirical Formula: C10H16
€ Trade and Other Names: d-limonene
€ Basic Manufacturer(s): Pet Chemicals
Rod Products
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B. Use Profile
The following is information on the current registered uses with an overview of
use sites and application methods. A detailed table of these use patterns of limonene is
provided in Appendix A.
For Limonene:
Type of Pesticide: Insecticide; repellent
Use Sites: Terrestrial Food & Feed Crop - compost and manure
Indoor Residential - cats and dogs repellent spray and shampoo,
pet living/sleeping quarters, household/domestic dwellings,
indoor premises, and human body/clothing while being worn
Outdoor Residential - household/domestic dwellings, outdoor
premises
Terrestrial Non-Food & Outdoor Residential - ornamental
herbaceous plants, ornamental lawns and turf, paved and
recreational areas
Aquatic Non-Food Residential - fountains, ponds and pools
Aquatic Non-Food Industrial - drainage systems
Aquatic Non-Food Outdoor - swamps/marshes/wetlands/stagnant
water
Target Pests: flying insects, flies, ants, cockroaches and/or mosquito larvae,
fleas, ticks, dogs, and cats
Formulation Types Registered: Emulsifiable concentrate
Granular
Impregnated Material
Pressurized Liquid
Liquid - Ready to use
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Method and Rates of Application:
Equipment - By hand
Method and Rate - Sprinkle
Household/Domestic Dwellings Outdoor Premises
.4015 Ib AI/1000 sq. ft.
Ornamental Herbaceous Plants
.4015 Ib AI/1000 sq. ft.
Ornamental Lawns and Turf
.4015 Ib AI/1000 sq. ft.
Paved Areas (Private Roads/Sidewalks)
.4015 Ib AI/1000 sq. ft.
Aquatic Sites (Drainage systems, ornamental ponds,
swamps/marshes/wetlands/stagnant water)
.549 Ib AI/A
When Needed
Use Practice Limitations:
Labels prohibit use on weanling kittens and caution against use of undiluted
product.
C. Estimated Usage of Pesticide
This section summarizes the best estimates available for the pesticide uses of
limonene. These estimates are derived from a variety of published and proprietary
sources available to the Agency. The data, reported on an aggregate and site (crop)
basis, reflect annual fluctuations in use patterns as well as the variability in using data
from various information sources.
The table below summarizes the pesticides use by site.
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Annual U.S. Usage Estimates for Limonene
Site
- Units/Area/Volume - Percent Quantity
Available Treated Treated Applied
Drainage systems
Eating establ, serv'g areas
Garbage dumps
Households, indoor (*,#)
dogs, cats & kennels (*, +)
Households, outdoor (*,@)
driveways & patios (*,@)
lawns & ornamentals (*,@)
Intermittently flooded areas
Lakes, ponds, impounded water
Manure
Orn'tal ponds, fountains, etc
Recreation areas, tables
Swamps, marshes, bogs, etc
Total - CA only
TOTAL - U.S.
NA
NA
NA
84,600 kHH
< 84,600 kHH
66,800 kHH
< 66,800 kHH
66,800 kHH
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
780 kHH
< 780 kHH
OkHH
OkHH
OkHH
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
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D. Regulatory History
Limonene was registered in the United States as an insecticide by the
United States Department of Agriculture in 1958. Subsequently, limonene was
first registered as an antimicrobial in 1971, and as a dog and cat repellent in
1983.
Limonene is an active ingredient in 15 currently registered products.
These products are ready-to-use solutions, emulsifiable concentrates, granular,
or impregnated material formulations. The products are used for pet flea and
tick control, as an insecticide spray, as an outdoor dog and cat repellent,
as a fly repellent tablecloth, as an insect repellent for use on humans, and
as a mosquito larvicide.
On May 4, 1988, the Agency announced (53 FR 15989) that it no longer
considered limonene to be an active ingredient if used in antimicrobial products. For
these products the Agency considered limonene to function as as inert ingredient (i.e.
odorants, perfumes). See 40 CFR 153.139(a).
In April 1994, limonene was granted an exemption from the requirement of a
tolerance when it is an inert ingredient used as a solvent or fragrance in pesticide
formulations (40 CFR 180.1001 (c), (e)).
The Food and Drug Administration lists limonene as a Generally Recognized as
Safe (GRAS) (21 CFR 182.60) food additive/flavoring and fragrance additive (soap,
perfume).
III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
Limonene occurs naturally in fruits (especially citrus fruits, vegetables, meats, and
spices). As an additive it is found in a variety of foods and beverages. It is listed by FDA as
Generally Recognized As Safe (GRAS) under Title 21 of the Code of Federal Regulations (21
CFR 182.60). Limonene is also used as an inert ingredient in pesticide formulations.
Limonene ranges in color from clear to light yellow with a mild citrus-
type odor. It is insoluble in water but soluble in mineral oils, fixed oils,
alcohols and ether, and very slightly soluble in glycerin.
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B. Human Health and Environmental Assessment
Adequate toxicological and environmental effects data on limonene are available to support
reregistration eligibility.
The Agency determined that limonene meets the criteria for a category of pesticide active
ingredients for which a reduced set of generic data requirements are appropriate for registration.
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. In considering limonene for reregistration eligibility, the Agency believes that it is
an active ingredient that meets the criterion for the following reasons:
1. Limonene has been established as an inert and has been granted an exemption from the
requirement of a tolerance when used as an inert in solvents or fragrances in antimicrobial
pesticide formulations. Limonene, a naturally occurring chemical, is found in high concentration
in citrus fruits and spices and is generally regarded as safe by FDA. It is widely used as a
flavoring and/or frangrance additive in foods, soaps, and perfumes.
2. Adverse effects from exposure are sufficiently well known and documented in the literature.
Use of the substance for pesticidal purposes does not require additional data; additional testing of
the pesticide active ingredient would not be expected to provide any additional information.
3. The 90-day dermal toxicity study is required to support registration of an insect repellent
formulation to be directly applied to humans dermally, and is to be tested using the formulation,
not technical limonene active ingredient alone. The study will be designed as a safety study.
Because the systemic toxicity is not anticipated, the requirement of a 90-day dermal toxicity study
is considered confirmatory.
4. A review of the available toxicity data indicates that adequate information is available to
characterize risks to humans and animals.
5. Limonene is not mutagenic or a developmental toxicant. The primary toxicological concerns,
dermal irritation in human and adverse effects in a small percentage of domestic animals, will
require precautionary statements on labels of products. Systemic toxicity in humans is not
expected to occur from pesticide uses since dermal irritation, which occurs at high doses leads to
self-discontinuation of product use.
An assessment of the data used in determining the reregistration eligibility of limonene is
detailed below.
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1. Toxicology Assessment
Adequate animal toxicological data on limonene are available and will support
reregistration eligibility.
Toxicology data on limonene reviewed here includes a 1992 National Toxicology
Program (NTP) 2-year cancer bioassay including shorter-term oral toxicity tests and a
comprehensive literature review, a developmental toxicity study in rat, a 2-week
preliminary study conducted for a 90-day dermal toxicity study in rat and the U.S. EPA
Risk Assessment Forum document entitled "Alpha2u-Globulin: Association with
Chemically Induced Renal Toxicity and Neoplasia in the Male Rat".
a. Acute Toxicity
The oral toxicity of limonene is relatively low. An oral lethal dose for
humans has been estimated at 1 oz. - 1 pint. Limonene has been administered
therapeutically to humans at doses of 20 g to dissolve gallstones. Systemic toxicity
from dermal exposure is anticipated to be lower than oral toxicity because dermal
penetration is expected to be less than 100% and since local dermal irritation would
occur at high exposure levels, causing discontinuation of exposure.
b. Subchronic Toxicity
In the NTP study, toxicity of limonene administered by gavage in corn oil
was assessed in CD rats and in B6C3F1 mice in 16-day, 13-week and 2-year
studies. In the 16-day study, no effects were observed in males at or below 825
mg/kg/day or in females at or below 1,650 mg/kg/day. Decreased body weights
were observed in males at 1,650 mg/kg/day and in females at 3,300 mg/kg/day.
Deaths occurred at 3,300 and 6,600 mg/kg/day among both males and females.
In the 13-week study, no effects were observed in females at or below 600
mg/kg/day. At 1,200 and 2,400 mg/kg/day clinical signs (lethargy, salivation)
were observed in males and females. Decreased body weight was observed in
males at 1,200 mg/kg/day and females at 2,400 mg/kg/day. Lacrimation, rough
coat and lethargy were noted at 1,200 mg/kg/day. Nephropathy related to alpha2u-
globin accumulation was observed in male rats at all doses (150 mg/kg/day above).
Mortality was increased in males and females at 2,400 mg/kg/day (highest dose
tested).
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c. Chronic toxicity
In the 2-year study, male rats were given 75 or 150 mg/kg/day and females
300 or 600 mg/kg/day limonene. At 150 mg/kg/day males had slightly decreased
body weight but at both doses developed alpha2u-globulin nephrotoxicity and renal
adenoma/adenocarcinoma. Females showed no effects at 300 mg/kg/day but at
600 mg/kg/day had slightly decreased body weight and increased mortality.
Mice given limonene at the same doses in the 16-day and 13-week studies
also showed limited evidence of toxicity at high doses, although some body weight
decrease in males was observed at all doses. Mice were given 250 or 500
mg/kg/day (males) or 500 or 1000 mg/kg/day (females) in the 2-year study.
Females at 1000 mg/kg/day had decreased body weight. No treatment-related
nephropathy or renal adenomas/carcinomas were observed in either sex in the 2-
year study.
d. Mutagenicity and Carcinogenicity
Limonene is not mutagenic in numerous assays. Renal adeno-
mas/carcinomas in male rats administered limonene for 2 years (NTP study) are
considered to be related to alpha2u-globulin-induced nephropathy and therefore are
not considered relevant to human risk assessment (Risk Assessment Forum
document on alpha2u-globulin nephropathy).
e. Developmental Toxicity
Limonene is not a developmental toxicant. Delayed ossification in bone
development may be observed at high doses that also cause maternal toxicity.
Several developmental toxicity studies were cited in the literature review of the
NTP study. No developmental effects were observed in rabbits administered
limonene up to 1,000 mg/kg; 6/21 maternal animals died and decreased body
weight was observed. At 250 mg/kg no maternal or developmental toxicity was
observed. Pregnant rats given 2,869 mg/kg limonene during days 9-15 of
gestation showed decreased body weight gain. Delayed ossification was seen in
fetuses at this dose, presumably secondary to maternal effects. A study in mice
(2,363 mg/kg during days 7-12 of gestation) also showed decreased maternal body
weight gain with increased incidence of abnormal bone formation in fetuses.
However, the dose administered in these two studies far exceeded limit doses.
In the rat developmental toxicity study submitted to the Agency in 1992,
a NOEL of 250 mg/kg/day for maternal and developmental toxicity was
determined. Small decrements in maternal body weight gain were observed at 500
and 1000 mg/kg/day and excess salivation at 1000 mg/kg/day. Slight but
statistically significant and dose-dependent increases in the number of liters and
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fetuses with 14 ribs instead of 13 were observed at 500 and 1000 mg/kg/day.
These effects are considered variations in skeletal formation, were not
accompanied by other effects, are secondary to maternal toxicity and do not
represent a concern for developmental toxicity of limonene.
f. Other Toxic Endpoints
Limonene is a known dermal irritant when applied at high concentrations
and may cause dermal sensitization. The 2-week preliminary study for the rat 90-
day dermal toxicity study submitted as 6 (a) (2) data showed that dermally-applied
technical limonene at 500, 1,000 or 1,500 mg/kg/day produced excessive dermal
irritation, usually after 1-3 days of application. No overt treatment-related systemic
toxicity or clinical signs were observed.
The 90-day dermal safety study on the formulation of the newly registered
product (Registration Number 045987-G) is required because the product use may
result in prolonged human dermal exposure through repeated skin applications.
The safety study on the formulated product is also needed because of the
combination of ingredients in the formulation. This will ensure the combination
in the formulation does not cause unexpected effects.
Another report cited in that submission indicated that doses of pine oil
blend (a mix of terpenes including limonene) up to 226 mg/kg/day did not produce
dermal irritation or systemic toxicity in rats after a 90-day exposure.
2. Exposure Assessment
a. Occupational and Residential
The primary toxicologic concerns for humans are dermal irritation and/or
sensitization from dermal exposure at high concentrations. Systemic toxicity is not
expected to occur from pesticide uses since dermal irritation, which occurs at high
doses, results in self-discontinuation of product use.
The primary toxicologic concerns for domestic animals are adverse
reactions in a small percentage of animals, cats in particular, exposed to limonene
in flea and tick spray, shampoo or dip products.
An animal safety study in cats on a flea dip indicated that a small
percentage of cats may develop transient symptoms when treated according to label
instructions and that kittens/young cats are more sensitive. Labels contain
Precautionary Statements indicating the potential for dermal irritation, sensitivity
of some animals to treatment, prohibiting use on weanling kittens and cautioning
against use of undiluted product.
10
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Symptoms of limonene toxicity may include hypothermia, tremors, ataxia
and excess salivation. Agitation and vocalization may also occur. Irritation of the
skin, particularly around the scrotum, has been reported and ocular irritation may
occur if eyes are accidentally exposed.
3. Risk Assessment
a. Occupational and Residential
Human exposure may occur during application of pet flea products,
application of pet flea products, application of animal repellent granules or insect
spray, or use of impregnated tablecloths. The tablecloth product containing
limonene to repel insects was exempted from tolerances. Toxicologic concerns for
humans from exposure to limonene are dermal irritation and sensitization.
Systemic toxicity is not anticipated to occur at doses below the threshold for
dermal irritation. Exposure to limonene would be discontinued if dermal irritation
occurred and is therefore self-limiting. Ocular irritation may also occur if
products are accidentally placed in the eye and not washed away.
Limonene is an active ingredient in several registered shampoo, dip and
spray products applied dermally to domestic animals to control fleas and ticks.
Most sprays and shampoos contain 5% limonene; dip concentrates (32-78%) are
diluted prior to use to less than 1% limonene. Adverse reactions in domestic
animals, particularly cats from exposure to limonene have been reported following
exposure to flea control products.
Additional precautionary statements on label are required to reduce adverse
effects.
C. Environmental Assessment
1. Environmental Fate
a. Environmental Chemistry, Fate and Transport
The Agency is relying on data available in the literature to assess the
environmental fate of limonene for its current uses.
b. Environmental Fate Assessment
Limonene [l-methyl-4-(l-methylethenyl)cyclohexene] is classified as a
terpene. It contains a carbon skeleton made up of isoprene units joined in a head-
to-tail way. The chemical is insoluble in water. Because limonene does not have
11
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functional groups for hydrolysis, and its cyclohexene ring and ethylene group are
known to be resistent to hydrolysis, the compound is expected to be stable in
water.
2. Ecological Effects
a. Ecological Effects Data
(1) Terrestrial Data
Terrestrial Animal Data
In order to establish the toxicity of limonene to birds, the following
tests would ordinarily be required using the technical grade material: one
avian single-dose oral (LD50) study on one species (preferably mallard duck
or bobwhite quail); two subacute dietary studies (LC50) tests on one species
of waterfowl (preferably the mallard duck) and one upland game-bird
species (preferably the bobwhite quail). However, because the present use
patterns of limonene were deemed low volume, the requirement for a
dietary test with a waterfowl species has been waived.
The data submitted for limonene includes studies on both technical
and formulated product. Because the first products registered were
basically indoor-use applications for controlling ticks and fleas on dogs and
cats, acute oral testing was not required for technical limonene. When the
first of two products with outdoor uses was proposed for registration, it
was concluded that any additional testing should be done using the
formulated product, which contains other active ingredients and inerts that
may be more toxic than limonene.
12
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Avian Acute Toxicity
The single-dose study submitted for the formulated product is
summarized below.
Species
Bobwhite
quail
o/oai1
4.015
LD50
(mg/kg)
>2000
Conclusions
Practically Nontoxic
'the formulated product tested also contains twofuranones
(0.073%) as active ingredients
These results indicate that the formulated product is
practically nontoxic to bobwhite quail. The guideline requirement
for the avian acute oral LD50 is fulfilled. (MRID #00146988)
Avian Subacute Dietary Toxicity
The acute dietary toxicity study submitted for the technical
product is summarized below.
Species
Bobwhite
quail
%ai
92
LC50
(ppm)
>5620
Conclusions
Practically
Nontoxic
The data indicate that technical limonene is practically
nontoxic to bobwhite quail on a dietary basis. The guideline
requirement for a dietary toxicity test with bobwhite quail is
satisfied.
The acute dietary toxicity studies submitted for a formulated
limonene product are summarized below.
13
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Species
Bobwhite
quail
Mallard
o/oai1
4.015
4.015
LC50
(ppm)
>5000
>5000
Conclusions
Practically
Nontoxic
Practically
Nontoxic
'the formulated product tested also contains two
furanones (0.073%) as active ingredients
The data indicate that the formulated product is practically
nontoxic to the bobwhite quail and mallard duck on a dietary basis.
The requirements for dietary toxicity tests are satisfied. (MRID #s
00109342, 00109341)
(2) Aquatic Data
Freshwater Fish Toxicity
In order to establish the toxicity of a pesticide to freshwater
fish, the minimum data required on the technical grade of the active
ingredient are two freshwater fish toxicity studies. One study
should use a coldwater species (preferably rainbow trout) and the
other a warmwater species (preferably bluegill sunfish). For the
same reasons noted for the terrestrial tests, some testing was
conducted on the formulated product rather than the technical.
The acute toxicity data for fish are summarized below for
technical limonene.
Species
Rainbow
trout
o/oai
92
LC50
(ppm)
80
Conclusions
Slightly Toxic
The data indicate that technical limonene is slightly toxic to
freshwater fish. The guideline requirements for acute toxicity
testing with a coldwater fish are fulfilled. (MRID #00146085)
14
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The acute toxicity data for fish are summarized below for
the formulated product.
Species
Rainbow
trout
Fathead
minnow
o/oai1
4.015
4.015
LC50
(ppm)
569-737
1490
Conclusions
Practically
Nontoxic
Practically
Nontoxic
'the formulated product tested also contains two furanones
(0.073%) as active ingredients
These data indicate that the formulated limonene product is
practically non-toxic to freshwater fish. The requirements for
testing with freshwater fish are satisfied. (MRID #s 00109343,
00109344)
Freshwater Invertebrate Toxicity
In order to establish the toxicity of a pesticide to freshwater
aquatic invertebrates, the minimum data required on the technical
grade of the active ingredient is one acute toxicity study. The
preferred test species is first instar Daphnia magna or early instar
amphipods, stoneflies, or mayflies.
The useful aquatic invertebrate toxicity data for technical
limonene are summarized below.
Species
Daphnia
magna
%ai
92
LC50
(ppm)
39
Conclusions
Slightly Toxic
These data indicate that technical limonene is slightly toxic
to freshwater invertebrates. The guideline requirement for an acute
toxicity study with a freshwater invertebrate is satisfied. (MRID
#00146085)
15
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The aquatic invertebrate toxicity data for the formulated
product are summarized below.
Species
Daphnia
magna
o/oai1
4.015
LC50
(ppm)
17-20
Conclusions
Slightly Toxic
'theformulated product tested also contains twofuranones (0.073%) as active
ingredients
These data indicate that the formulated product is slightly
toxic to freshwater invertebrates. The requirement for acute
toxicity studies with freshwater invertebrates is satisfied. (MRID
#00109345)
b. Ecological Effects Risk Assessment
Risk to Terrestrial Animals
Avian Acute Oral and Subacute Dietary Effects
Limonene has not been quantitatively assessed. However,
based on the lack of toxicity of limonene to birds, little risk is
anticipated.
Potential risk to birds might occur from ingestion of
granules spread on lawns, driveways, and sidewalks; or from
consumption of contaminated insects around sprayed manure heaps,
compost piles, garbage pails, and dumpsters.
"The Agency is unable to calculate an acute risk quotinent
for birds, because toxicity test effect levels are unknown. The
acceptable avian acute oral study demonstrated an LD50 greater than
2,000 mg/kg for the formulated product. The Agency's Guidelines
for Avian Acute Oral testing specify that a study may demonstrate
that the actual LD50 is greater than 2,000 mg/kg, in lieu of
demonstrating an actual LD50. Because the submitted study tested
up to the maximum 2,000 mg/kg level and no indications of toxicity
were noted, the Agency has determined it is reasonable to assume
that the regulatory levels of concern for acute effects will not be
exceeded."
16
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The risk to birds from possible consumption of contaminated
insects around the outdoor sites where insects are sprayed cannot be
quantitatively assessed. Directions for use on the label for EPA
Registration No. 45987-2 include spraying "to wet" crawling ants,
roaches, and flying insects; thoroughly spraying ant trails on
sidewalks, paths, and buildings, repeating the treatment a second
time if ants reappear a few days later; and liberally spraying and
thoroughly wetting manure heaps, compost piles, and insect-
attracting garbage pails and dumpsters. Insects (e.g., flies, beetles,
larva) contaminated by such spraying might be consumed by a
variety of birds. However, based on the lack of toxicity of
limonene to birds, little risk is anticipated.
Mammalian Acute Effects
The acute oral LD50 value for the rat is greater than 5000
mg/kg, which classifies it as practically nontoxic. Because granular
limonene is registered as a mammalian repellent and is practically
nontoxic, it is not anticipated that granules would be consumed in
sufficient quantities to be a risk to mammals.
Risk to Aquatic Animals
Mosquito Larvicide Use
The LOG for freshwater invertebrates was exceeded (risk
quotient = 1.5) for the mosquito larvicide use. However, the end-
use product is expected to dissipate rapidly, by break up of the oily
film. Thus, due to the likely short duration of the effect, there is
not a major ecological concern.
Direct Application to Water
The mosquito larvicide product is applied directly to water
where breeding mosquitos are likely to be. Potential risk to aquatic
organisms is estimated by the EEC/LC50 (or EC50). This is the risk
quotient (RQ). The Level of Concern (LOG) for this endpoint is a
risk quotient greater than or equal to 0.5 for nonendangered species
and 0.05 for endangered species.
The EEC is calculated below. It is based on the maximum
direct application to water, which is 5 gallons per acre. For this
17
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use a six inch water body scenario is used since mosquito breeding
areas are likely to be in shallow water.
EEC = 34.15 Ibsx734ppb
(where34.15 = max. appL rate in Ibsproduct/acre which equals 5 gal/acre x 6.83 Ibs/gal and 734ppb
= EEC for a direct application ofl Ib. to 6 Inches of water) = 25ppm)
The aquatic organisms of concern in this case, based on the
toxicity of the formulated product to daphnids, are aquatic
invertebrates with a formulated product EC50 of 17-20 ppm. The
risk quotient for these organisms is 25/17 = 1.5, which exceeds the
level of concern. However, due to the nature of the product and
the likely short duration of the effect, there is not a major
ecological concern.
Other (Non-larvicide) Uses
Minimal risks to nonendangered and endangered aquatic
species are expected from runoff into ponded waters 6-feet deep
from applications of the granular product.
Ground Application
Runoff of limonene into water bodies could present a potential
risk to aquatic organisms. Runoff of pesticide from ground
applications was estimated by multiplying the maximum application
rate (Ibs ai/acre) by the percent runoff (based on solubility) from a
10-acre drainage basin into a 1-acre water body. Because solubility
data are unavailable for limonene the maximum pesticide runoff,
which is 5%, was assumed. Based on these assumptions the
maximum aquatic concentration of limonene is 0.5 ppm for a 6-ft.
deep water body, as calculated below.
Expected Aquatic Residues
[maximum application rate = 17.5 Ibs ai/acre]
Runoff = maximum application rate (Ibs ai/acre) x
% runoff x 10-acre drainage basin
= 17.5 Ibs ai/acre x 0.051 x 10 acres
= 8.75 Ibs ai
18
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EEC = runoff (Ibs ai) x EEC (ppb) of a 1 Ib ai/acre direct
application for a 6-ft. deep pond2
= 8.75 x 61 ppb for 6-ft. deep pond
= 0.533 ppm
Vunoff is assumed to be 5%
2from Urban and Cook (1986)
Potential risk to aquatic organisms is estimated by the
EEC/LC50 (or EC50). This is the risk quotient (RQ). The Level of
Concern (LOG) for this endpoint is a risk quotient greater than or
equal to 0.5 for nonendangered species and 0.05 for endangered
species. The risk quotients are shown in the table below.
Aquatic
organism
Fish
Invertebrates
EEC
(ppm)
0.5
RQ
(EEC/
LC501)
0.006
0.03
'the ECSO value is used for invertebrates
Based on these values, minimal risks to nonendangered and
endangered aquatic species are expected from runoff into ponded
waters 6-feet deep from applications of the granular product.
19
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IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission
of relevant data concerning an active ingredient, whether products containing the active
ingredients are eligible for reregistration. The Agency has previously identified and
required the submission of the generic (i.e. active ingredient specific) data required to
support reregistration of products containing limonene active ingredients. The Agency has
completed its review of these generic data, and has determined that the data are sufficient
to support reregistration of all products containing limonene. Appendix B identifies the
generic data requirements that the Agency reviewed as part of its determination of
reregistration eligibility of limonene, and lists the submitted studies that the Agency found
acceptable.
The data identified in Appendix B were sufficient to allow the Agency to assess the
registered uses of limonene and to determine that limonene can be used without resulting
in unreasonable adverse effects to humans and the environment. The Agency therefore
finds that all products containing limonene as the active ingredients are eligible for
reregistration. The reregistration of particular products is addressed in Section V of this
document.
The Agency made its reregistration eligibility determination based upon the target
data base required for reregistration, the current guidelines for conducting acceptable
studies to generate such data and the data identified in Appendix B. Although the Agency
has found that all uses of limonene 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 limonene, if new
information comes to the Agency's attention or if the data requirements for registration
(or the guidelines for generating such data) change.
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredients
limonene, the Agency has sufficient information on the health effects of limonene
and on its potential for causing adverse effects in fish and wildlife and the
environment. Therefore, the Agency concludes that products containing limonene
for all uses are eligible for reregistration.
The Agency has determined that limonene products, labeled and used as
specified in this Reregistration Eligibility Decision, will not pose unreasonable
risks or adverse effects to humans or the environment.
20
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2. Eligible and Ineligible Uses
The Agency has determined that all uses of limonene are eligible for
reregistration.
B. Regulatory Position
The following is a summary of the regulatory positions and rationales for
limonene. Where labeling revisions are imposed, specific language is set forth in Section
V of this document.
C. Tolerance Reassessment
In April 1994, limonene was granted an exemption from the requirement of a
tolerance when it is an inert ingredient used as a solvent or fragrance in pesticide
formulations [cite Federal Register citation; i.e., 40 CFR §180.1001 (c), (e)].
21
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V. ACTIONS REQUIRED BY REGISTRANTS
This section specifies the data requirements and responses necessary for the reregistration
of both manufacturing-use and end-use products.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of limonene for the
above eligible uses has been reviewed and determined to be substantially complete.
However, additional confirmatory data is needed for the 90-Day
Dermal Toxicity study to fulfill the data requirements.
2. Labeling Requirements for Manufacturing-Use Products
To remain in compliance with FIFRA, manufacturing use product (MP)
labeling must be revised to comply with all current EPA regulations, PR Notices
and applicable policies. The MP labeling must bear the following statement under
Directions For Use:
"Only for formulation into an [fill blank with
Insecticide, Herbicide or the applicable term which describes the type of pesticides
use(s)] for the following use(s): (fill blank only with those
uses that are being supported by MP registrant)."
An MP registrant may, at his/her discretion, add one of the following
statements to an MP label under "Directions for Use" to permit the reformulation
of the product for a specific use or all additional uses supported by a formulator
or user group:
(a) "This product may be used to formulate products for
specific use(s) not listed on the MP label if the
formulator, user group, or grower has complied with
U.S. EPA submission requirements regarding the support
of such use(s)."
(b) "This product may be used to formulate products for any
additional use(s) not listed on the MP label if the
formulator, user group, or grower has complied with
U.S. EPA submission requirements regarding the support
of such use(s)."
22
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B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide after a determination of eligibility
has been made. The product specific data requirements are listed in Appendix G,
the Product Specific Data Call-in Notice.
Registrants must review previous data submissions to ensure that they meet
current EPA acceptance criteria (Appendix F; Attachment E) and if not, commit
to conduct new studies. If a registrant believes that previously submitted data meet
current testing standards, then study MRID numbers should be cited according to
the instructions in the Requirement Status and Registrants Response Form provided
for each product.
2. Labeling Requirements for End-Use Products
Worker Protection Standard
To the Agency's knowledge, at this time all registered uses of limonene are
outside the scope of the Worker Protection Standard for Agricultural Pesticides
(WPS). The Agency will not establish entry restrictions at this time for limonene
end-use products.
The labeling language for the end-use products:
(a) End-Use Products (except the mosquito larvicide use)
Do not apply directly to water, or to areas where surface
water is present or to intertidal areas below the mean high-
water mark. Do not contaminate water when disposing of
equipment washwater or rinsate.
(b) End-Use Products (mosquito larvicide use)
Do not contaminate water when disposing of equipment
washwater or rinsate. Consult with your State Agency
in charge of fish and game before applying to public
waters to determine if a permit is needed.
The labels and labeling of all products must comply with EPA's current
regulations and requirements as specified in 40 CFR §156.10and other applicable
notices.
23
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3. Additional Label Requirements
Although the toxicology of limonene has been adequately characterized
and toxicity is generally relatively low, adverse effects may occasionally
occur in pets exposed to limonene flea/tick dips, shampoos and sprays.
Labels contain precautionary statements regarding sensitivity among some
individual animals, dermal/ocular irritation, use on kittens or nursing
mothers and warning against using undiluted product. Although the labels
provide appropriate information, the Agency requires the following changes
to strengthen the language and further reduce risk of adverse effects:
- Add: Applicators of flea and tick dip (concentrates), spray or
shampoo products are to use protective gloves to reduce the risk of
dermal irritation or dermal sensitization.
- Add: Flea dip concentrates may harm animals when used at greater
strength than specified on the label.
- Change the age for product use on kittens/puppies to several months or
a year.
- Change the statement: "Use with care on nursing animals" to "Do not
use on nursing animals or any animal which is in poor health".
- Provide a list of symptoms, which may occur when animals are sensitive
to the product, to the precautionary statement "individual animals may
may be more sensitive to the product".
4. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling
for 26 months from the date of the issuance of this Reregistration Eligibility Decision
(RED). Persons other than the registrant may generally distribute or sell such products for
50 months from the date of the issuance of this RED. However, existing stocks time
frames will be established case-by-case, depending on the number of products involved,
the number of label changes, and other factors. Refer to "Existing Stocks of Pesticide
Products; Statement of Policy"; Federal Register, Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell limonene
products bearing old labels/labeling for 26 months from the date of issuance of this RED.
Persons other than the registrant may distribute or sell such products for 50 months from
the date of the issuance of this RED. Registrants and persons other than registrants remain
obligated to meet pre-existing Agency-imposed label changes and existing stocks
requirements applicable to products they sell or distribute.
24
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25
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26
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VI. APPENDICES
27
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28
-------
APPENDIX A. Table of Use Patterns Subject to Reregistration
29
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30
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Date 09/14/94 € Time 14:00
APPENDIX A € CASE 3083, [Limonene] Chemical 079701 [Limonene]
LUIS 1.5 € Page 1
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment € Rate (AI un- Rate (AI Tex. ® Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
FOOD/FEED USES
COMPOST/COMPOST PILES
Compost treatment., When needed., Pump spray RTU
bottle.
Use Group: TERRESTRIAL FOOD+FEED CROP
UC * NS NS NS NS NS
MANURE
Spray., When needed., Pump spray bottle. RTU
NON-FOOD/NON-FEED
Use Group: TERRESTRIAL FOOD+FEED CROP
UC * NS NS NS NS NS
CATS (ADULTS/KITTENS)
Animal treatment (spray)., Not on label., PRL
Aerosol can.
Use Group: INDOOR RESIDENTIAL
UC * NS NS NS
Animal treatment (spray)., When needed., PRL
Aerosol can.
Animal treatment (spray)., When needed., RTU
Pump spray bottle.
Dip treatment., When needed., Not on label. EC
Shampoo., When needed., By hand.
Sponge-on., When needed., Sponge.
Sprinkle., When needed., Not on label.
DOGS/CANINES (ADULTS/PUPPIES)
Animal treatment (spray)., Not on label., PRL
Aerosol can.
UC * NS NS
NS
EC
EC
RTU
RTU
EC
EC
EC
EC
NA
NA
NA
NA
NA
NA
NA
NA
UC
UC
UC
UC
UC
UC
UC
UC
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
AN
NS
AN
NS
AN
NS
AN
NS
NS
NS
NS
NS
NS
NS
NS
NS
Use Group: INDOOR RESIDENTIAL
UC * NS NS NS
Animal treatment (spray)., When needed.,
Aerosol can.
UC
NS
NS
NS
Animal treatment (spray)., When needed.,
Pump spray bottle.
UC * NS
-------
Date 09/14/94 € Time 14:00
APPENDIX A € CASE 3083, [Limonene] Chemical 079701 [Limonene]
LUIS 1.5
Page
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment € Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
DOGS/CANINES (ADULTS/PUPPIES) (con't)
Dip treatment., When needed., Not on label. EC NA
EC NA
Shampoo., When needed., By hand. RTU NA
RTU NA
Sponge-on., When needed., Sponge. EC NA
EC NA
Sprinkle., When needed., Not on label. EC NA
EC NA
DRAINAGE SYSTEMS
Water treatment (surface)., When needed., By EC NA
hand.
HOUSEHOLD/DOMESTIC DWELLINGS INDOOR PREMISES
Indoor general surface treatment., When RTU NA
needed., Pump spray bottle.
HOUSEHOLD/DOMESTIC DWELLINGS OUTDOOR PREMISES
Impregnated covering., When needed., By IMPR NA
hand.
Outdoor general surface spray., When RTU NA
needed., Pump spray bottle.
Sprinkle., When needed., Not on label.
NA
HUMAN BODY/CLOTHING WHILE BEING WORN (INSECT CONTROL)
Clothing treatment., When needed., Sprayer. RTU NA
Skin contact treatment., When needed., By RTU NA
hand.
Use Group: INDOOR RESIDENTIAL (con't)
NS AN NS
NS NS NS
NS AN NS
NS NS NS
NS AN NS
NS NS NS
NS AN NS
NS NS NS
Use Group: AQUATIC NON-FOOD INDUSTRIAL
.549 Ib A * NS NS NS NS NS NS
Use Group: INDOOR RESIDENTIAL
UC * NS NS NS NS NS NS
UC
UC
UC
UC
UC
UC
UC
UC
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Use Group: OUTDOOR RESIDENTIAL
UC * NS NS NS
UC
4.015E-04 Ib
sq.ft
* NS
NS
NS
NS
NS
NS
Use Group: INDOOR RESIDENTIAL
UC * NS NS NS
UC * NS NS NS
NS NS NS
NS NS NS
NS AN NS
NS 0.12 NS
NS 0.12 NS
Spray., When needed., Hand held sprayer.
UC
NS NS
NS
NS 0.12
NS
-------
Date 09/14/94 € Time 14:00
APPENDIX A € CASE 3083, [Limonene] Chemical 079701 [Limonene]
LUIS 1.5 € Page 3
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. tt Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment € Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
ORNAMENTAL HERBACEOUS PLANTS
Sprinkle., When needed., Not on label. G NA
ORNAMENTAL LAWNS AND TURF
Sprinkle., When needed., Not on label. G NA
ORNAMENTAL PONDS/AQUARIA
Water treatment (surface)., When needed., By EC NA
hand.
PAVED AREAS (PRIVATE ROADS/SIDEWALKS)
Sprinkle., When needed., Not on label. G NA
PET LIVING/SLEEPING QUARTERS
Animal bedding/litter treatment., Not on PRL NA
label., Aerosol can.
Animal bedding/litter treatment., When PRL NA
needed., Aerosol can.
Animal bedding/litter treatment., When RTU NA
needed., Pump spray bottle.
RECREATIONAL AREAS
Impregnated covering., When needed., By IMPR NA
hand.
SWAMPS /MARSHES /WETLANDS /STAGNANT WATER
Water treatment (surface)., When needed., By EC NA
hand.
WIDE AREA/GENERAL OUTDOOR TREATMENT (PUBLIC HEALTH USE)
Spray., When needed., Sprayer. EC NA
Use Group: TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL
4.015E-04 Ib * NS NS NS NS AN NS
sq.ft
Use Group: TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL
4.015E-04 Ib * NS NS NS NS AN NS
sq.ft
Use Group: AQUATIC NON-FOOD RESIDENTIAL
.549 Ib A * NS NS NS NS NS NS
Use Group: TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL
4.015E-04 Ib * NS NS NS NS AN NS
sq.ft
Use Group: INDOOR RESIDENTIAL
UC * NS NS NS NS NS NS
UC * NS NS
NS NS AN NS
UC
NS NS
NS
NS NS
NS
Use Group: TERRESTRIAL NON-FOOD CROP
UC * NS NS NS NS NS NS
Use Group: AQUATIC NON-FOOD OUTDOOR
.549 Ib A * NS NS NS NS NS NS
Use Group: TERRESTRIAL NON-FOOD CROP
1.373 Ib A * NS NS NS NS 14 NS
-------
Date 09/14/94 € Time 14:00
APPENDIX A € CASE 3083, [Limonene] Chemical 079701 [Limonene]
LUIS 1.5 € Page 4
SITE Application Type, Application Form(s)
Timing, Application Equipment €
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr.
Rate (AI un- Rate (AI Tex. ® Max. Rate unless noted Interv Entry
less noted unless noted Max. /crop /year otherwise)/A] (days) Interv
otherwise) otherwise) Dose cycle /crop /year [day (s) '.
cycle
Geographic Limitations
Allowed Disallowed
Use
Limitations
Codes
USES ELIGIBLE FOR REREGISTRATION
NOT SPECIFIED
SITE TERM TOO GENERAL
Animal treatment (spray)., When needed.,
Pump spray bottle.
Use Group: USE GROUP FOR SITE 00000
UC * NS NS NS NS
-------
Date 09/14/94 € Time 14:00 APPENDIX A € CASE 3083, [Limonene] Chemical 079701 [Limonene] LUIS 1.5 € Page 5
HEADER ABBREVIATIONS
Min. Appl. Rate (AI unless : Minimum dose for a single application to a single site. System calculated. Microbial claims only.
noted otherwise)
Max. Appl. Rate (AI unless : Maximum dose for a single application to a single site. System calculated.
noted otherwise)
Soil Tex. Max. Dose : Maximum dose for a single application to a single site as related to soil texture (Herbicide claims only).
Max. # Apps ® Max. Rate : Maximum number of Applications at Maximum Dosage Rate. Example: "4 applications per year" is expressed as "4/1 yr"; "4 applications per 3
years" is expressed as "4/3 yr"
Max. Dose [(AI unless : Maximum dose applied to a site over a single crop cycle or year. System calculated.
noted otherwise)/A]
Min. Interv (days) : Minimum Interval between Applications (days)
Restr. Entry Interv (days) : Restricted Entry Interval (days)
SOIL TEXTURE FOR MAX APP. RATE
* : Non-specific
C : Coarse
M : Medium
F : Fine
O : Others
FORMULATION CODES
EC : EMULSIFIABLE CONCENTRATE
G : GRANULAR
IMPR : IMPREGNATED MATERIAL
PRL : PRESSURIZED LIQUID
RTU : LIQUID-READY TO USE
ABBREVIATIONS
AN : As Needed
NA : Not Applicable
NS : Not Specified (on label)
UC : Unconverted due to lack of data (on label), or with one of following units: bag, bait, bait block, bait pack, bait station, bait station(s), block, briquet,
briquets, bursts, cake, can, canister, capsule, cartridges, coil, collar, container, dispenser, drop, eartag, grains, lure, pack, packet, packets, pad, part,
parts, pellets, piece, pieces, pill, pumps, sec, sec burst, sheet, spike, stake, stick, strip, tab, tablet, tablets, tag, tape, towelette, tray, unit, --
APPLICATION RATE
DCNC : Dosage Can Not be Calculated
No Calc : No Calculation can be made
W : PPM calculated by weight
V : PPM Calculated by volume
cwt : Hundred Weight
nnE-xx : nn times (10 power -xx); for instance, "1.234E-04" is equivalent to ".0001234"
-------
36
-------
APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
37
-------
38
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case Limonene covered by this Reregistration Eligibility Decision
Document. It contains generic data requirements that apply to Limonene in all products,
including data requirements for which a "typical formulation" is the test substance.
The data table is organized in the following format:
1. Data Requirement (Column 1). The data requirements are listed in the order in
which they appear in 40 CFR Part 158. the reference numbers accompanying each test refer
to the test protocols set in the Pesticide Assessment Guidelines, which are available from the
National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703)
487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
0 Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files,
this column lists the identifying number of each study. This normally is the Master Record
Identification (MRID) number, but may be a "GS" number if no MRID number has been
assigned. Refer to the Bibliography appendix for a complete citation of the study.
39
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40
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of LIMONENE
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
61-1
61-2A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
63-14
Chemical Identity
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Water Partition
PH
Stability
Oxidizing/Reducing Action
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
41962101
41962101
41962101
41962101
41962101
N/A
41962101
41962101
41962101
41962101
WAIVED
43107701, 41962101
41
-------
Data Supporting Guideline Requirements for the Reregistration of LIMONENE
REQUIREMENT
USE PATTERN
CITATION(S)
63-15 Flammability
63-16 Explodability
63-17 Storage stability
63-18 Viscosity
63-19 Miscibility
63-20 Corrosion characteristics
63-21 Dielectric breakdown volt
64-1 Submittal of Samples
ECOLOGICAL EFFECTS
71-1A Acute Avian Oral - Quail/Duck
71-1B Acute Avian Oral - Quail/Duck
TEP
71-2A Avian Dietary - Quail
71-2B Avian Dietary - Duck
71-3 Wild Mammal Toxicity
71-4A Avian Reproduction - Quail
71-4B Avian Reproduction - Duck
71-5A Simulated Field Study
71-5B Actual Field Study
72-1A Fish Toxicity Bluegill
72-IB Fish Toxicity Bluegill - TEP
ALL
ALL
00109340
WAIVED
ALL
WAIVED
42
-------
Data Supporting Guideline Requirements for the Reregistration of LIMONENE
REQUIREMENT
USE PATTERN
CITATION(S)
72-1C Fish Toxicity Rainbow Trout
72-ID Fish Toxicity Rainbow Trout- TEP
72-2A Invertebrate Toxicity
72-2B Invertebrate Toxicity - TEP
72-3A Estuarine/Marine Toxicity - Fish
72-3B Estuarine/Marine Toxicity -
Mollusk
72-3C Estuarine/Marine Toxicity -
Shrimp
72-3D Estuarine/Marine Toxicity Fish-
TEP
72-3E Estuarine/Marine Toxicity Mollusk
-TEP
72-3F Estuarine/Marine Toxicity Shrimp
-TEP
72-4A Early Life Stage Fish
72-4B Life Cycle Invertebrate
72-5 Life Cycle Fish
72-6 Aquatic Organism Accumulation
72-7A Simulated Field - Aquatic
Organisms
72-7B Actual Field - Aquatic Organisms
122-1A Seed Germination/Seedling
Emergence
ALL
WAIVED
43
-------
Data Supporting Guideline Requirements for the Reregistration of LIMONENE
REQUIREMENT USE PATTERN CITATION(S)
122-IB Vegetative Vigor
122-2 Aquatic Plant Growth
123-1A Seed Germination/Seedling
Emergence
123-IB Vegetative Vigor
123-2 Aquatic Plant Growth
124-1 Terrestrial Field
124-2 Aquatic Field
141-1 Honey Bee Acute Contact
141-2 Honey Bee Residue on Foliage
141-5 Field Test for Pollinators
TOXICOLOGY
81-1 Acute Oral Toxicity - Rat
81-2 Acute Dermal Toxicity -
Rabbit/Rat
81-3 Acute Inhalation Toxicity - Rat
81-4 Primary Eye Irritation - Rabbit
81-5 Primary Dermal Irritation - Rabbit
81-6 Dermal Sensitization - Guinea Pig
81-7 Acute Delayed Neurotoxicity - Hen ALL N/A
82-1A 90-Day Feeding - Rodent
82-IB 90-Day Feeding - Non-rodent
44
-------
Data Supporting Guideline Requirements for the Reregistration of LIMONENE
REQUIREMENT
USE PATTERN
CITATION(S)
82-2 21-Day Dermal - Rabbit/Rat
82-3 90-Day Dermal - Rodent
82-4 90-Day Inhalation - Rat
82-5A 90-Day Neurotoxicity - Hen
82-5B 90-Day Neurotoxicity - Mammal
83-1A Chronic Feeding Toxicity - Rodent
83-IB Chronic Feeding Toxicity -
Non-Rodent
83-2A Oncogenicity - Rat
83-2B Oncogenicity - Mouse
83-2B Oncogenicity - Mouse
83-3A Developmental Toxicity - Rat
83-3B Developmental Toxicity - Rabbit
83-4 2-Generation Reproduction - Rat
84-2A Gene Mutation (Ames Test)
84-2B Structural Chromosomal
Aberration
84-4 Other Genotoxic Effects
85-1 General Metabolism
85-2 Dermal Penetration
86-1 Domestic Animal Safety
ALL
DATA GAP
ALL
42316301
45
-------
Data Supporting Guideline Requirements for the Reregistration of LIMONENE
REQUIREMENT
USE PATTERN
CITATION(S)
OCCUPATIONAL/RESIDENTIAL EXPOSURE
132-1A Foliar Residue Dissipation
132-IB Soil Residue Dissipation
133-3 Dermal Passive Dosimetry
Exposure
133-4 Inhalation Passive Dosimetry
Exposure
231 Estimation of Dermal Exposure at
Outdoor Sites
232 Estimation of Inhalation Exposure
at Outdoor Sites
233 Estimation of Dermal Exposure at
Indoor Sites
234 Estimation of Inhalation Exposure
at Indoor Sites
ENVIRONMENTAL FATE
160-5 Chemical Identity
161-1 Hydrolysis
161-2 Photodegradation - Water
161-3 Photodegradation - Soil
161-4 Photodegradation - Air
162-1 Aerobic Soil Metabolism
162-2 Anaerobic Soil Metabolism
ALL
WAIVED
ALL
WAIVED
46
-------
Data Supporting Guideline Requirements for the Reregistration of LIMONENE
REQUIREMENT
USE PATTERN
CITATION(S)
162-3 Anaerobic Aquatic Metabolism
162-4 Aerobic Aquatic Metabolism
163-1 Leaching/Adsorption/Desorption
163-2 Volatility - Lab
163-3 Volatility - Field
164-1 Terrestrial Field Dissipation
164-2 Aquatic Field Dissipation
164-3 Forest Field Dissipation
164-5 Long Term Soil Dissipation
165-1 Confined Rotational Crop
165-2 Field Rotational Crop
165-3 Accumulation - Irrigated Crop
165-4 Bioaccumulation in Fish
165-5 Bioaccumulation - Aquatic
NonTarget
166-1 Ground Water - Small Prospective
166-2 Ground Water - Small
Retrospective
166-3 Ground Water - Irrigated
Retrospective
201-1 Droplet Size Spectrum
202-1 Drift Field Evaluation
ALL
WAIVED
ALL
WAIVED
47
-------
Data Supporting Guideline Requirements for the Reregistration of LIMONENE
REQUIREMENT USE PATTERN CITATION(S)
RESIDUE CHEMISTRY
171-4A Nature of Residue - Plants
171-4B Nature of Residue - Livestock
171-4C Residue Analytical Method - Plants
171-4D Residue Analytical Method -
Animal
171-4E Storage Stability
171-4F Magnitude of Residues - Potable
H2O
171-4G Magnitude of Residues in Fish
171-4H Magnitude of Residues - Irrigated
Crop
171-41 Magnitude of Residues - Food
Handling
171-4J Magnitude of Residues -
Meat/Milk/Poultry/Egg
171-4K Crop Field Trials
171-4L Processed Food
171-5 Reduction of Residues
171-6 Proposed Tolerance
171-7 Support for Tolerance
171-13 Analtyical Reference Standard
48
-------
49
-------
50
-------
APPENDIX C. Citations Considered to be Part of the Data
Base Supporting the Reregistration of Limonene
51
-------
52
-------
GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated
elsewhere in the Reregistration Eligibility Document. Primary sources for studies in
this bibliography have been the body of data submitted to EPA and its predecessor
agencies in support of past regulatory decisions. Selections from other sources
including the published literature, in those instances where they have been considered,
are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the
case of published materials, this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency has sought to identify
documents at a level parallel to the published article from within the typically larger
volumes in which they were submitted. The resulting "studies" generally have a
distinct title (or at least a single subject), can stand alone for purposes of review and
can be described with a conventional bibliographic citation. The Agency has also
attempted to unite basic documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID number". This number is unique
to the citation, and should be used whenever a specific reference is required. It is not
related to the six-digit "Accession Number" which has been used to identify volumes of
submitted studies (see paragraph 4 (d) (4) below for further explanation). In a few
cases, entries added to the bibliography late in the review may be preceded by a nine
character temporary identifier. These entries are listed after all MRID entries. This
temporary identifying number is also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the
Agency has shown an identifiable laboratory or testing facility as the author.
When no author or laboratory could be identified, the Agency has shown the
first submitter as the author.
b. Document date. The date of the study is taken directly from the document.
When the date is followed by a question mark, the bibliographer has deduced
the date from the evidence contained in the document. When the date appears
53
-------
as (19??), the Agency was unable to determine or estimate the date of the
document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to
create or enhance a document title. Any such editorial insertions are contained
between square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the
trailing parentheses include (in addition to any self-explanatory text) the
following elements describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the
word "under" is the registration number, experimental use permit
number, petition number, or other administrative number associated
with the earliest known submission.
(3) Submitter. The third element is the submitter. When authorship is
defaulted to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume
in which the original submission of the study appears. The six-digit
accession number follows the symbol "CDL," which stands for
"Company Data Library." This accession number is in turn followed by
an alphabetic suffix which shows the relative position of the study within
the volume.
54
-------
BIBLIOGRAPHY
MRID
CITATION
00042305 Purdue Frederick Company (1975) Primary Dermal Irritation in Albino
Rabbits: Project # MB 79-3580. (Unpublished study received Sep 8, 1980
under 10279-7; CDL:243192-B)
00042306 Napp Laboratories, Limited (1980) A Summary of the Experience of the NAPP
Pharmaceutical Group in the Manufacture and Marketing of Prioderm(R)
Lotion. (Unpublished study received Sep 8, 1980 under 10279-7; submitted by
Purdue Frederick Co., Norwalk, Conn.; CDL:243192-C)
00042310 SCM Corporation (1979) Material Safety Data Sheet: File No. 20B21.
(Unpublished study received Sep 8, 1980 under 10279-7; submitted by Purdue
Frederick Co., Norwalk, Conn.; CDL:243192-H)
00042311 Purdue Frederick Company (19??) General Chemistry: Prioderm Lotion.
(Unpublished study received Sep 8, 1980 under 10279-7; CDL:243192-J)
00042316 Purdue Frederick Company (19??) Basic Manufacturing Process for Prioderm
Lotion. (Unpublished study received Sep 8, 1980 under 10279-7;
CDL:243192-K)
00043010 Hercules Powder Company, Incorporated (1962) Hercules(R) Pine Oils:
Yarmor(R) 302, 302W, 317, 350, F, and Herco(R): Summary of Toxicological
Investigations. Wilmington, Del.: Hercules. (Bulletin T-103;
also ~ In ~ unpublished submission received May 2, 1962 under unknown
admin, no.; CDL:104228-A)
00046417 Shapiro, R.L. (1967) Efficacy Reports Using Air Fresheners in Sanitation
Tests, Germicidal Tests and Others. (Unpublished study received Feb 29, 1968
under unknown admin, no.; prepared by Hudson Laboratories, Inc., submitted
by Dow Chemical U.S.A., Midland, Mich.; CDL:118638-A)
00054054 Organic Chemicals (1974) Toxicity Tests: Terpene Alcohols. (Unpublished
study received May 19, 1976 under 13648-7; CDL: 230193-A)
00057723 Hercules Powder Company (1962) Hercules(R) Terpene Hydrocarbons and
Solvents. Wilmington, Del.: Hercules. (Bulletin T-108; unpublished study
55
-------
BIBLIOGRAPHY
MRID
CITATION
received May 19, 1976 under 13648-7; submitted by Organic Chemicals, Div.
of SCM Corp., Jacksonville, Fla.; CDL:230193-B)
00063204 B.C. Davis (19??) Limonene: 1-Methyl-A-(1-methylethenyl) cyclohexene;
P-Mentha-1, B-diene. (Unpublished study received Jun 12, 1976 under
41989-EX-l; CDL:234091-A)
00063205 Young, J.A.; Doyle, R.L. (1974) Acute Toxicity and Irritation Studies of
Mac's Citrus Base Waterless Hand Cleaner: Report No. 74053-21.
(Unpublished study received Jun 12, 1978 under 41989EX-1; prepared by Hill
Top Testing Services, Inc., submitted by E.G. Davis, Titusville, Fla.;
CDL:234091-B)
00063206 Young, J.A.; Doyle, R.L. (1974) Primary Skin and Acute Eye Irritation
Studies of 15% Emul, WHC, 35% Citrus Oil, 50% H20, 8.9 and PAD # 1:
Report No. 74-131-21. (Unpublished study received Jun 12, 1976 under
41989-EX-l; prepared by American Biomedical Corp., submitted by E.G.
Davis, Titusville, Fla.; CDL:234091-C)
00076995 Berlin, C.H.; Lesonsky, R.L. (1980) Dermal Toxicity on Rabbits: Test Report
No. 1-2-27836-1. (Unpublished study received May 5, 1981 under 45987-1;
prepared by Bio-Technics Laboratories, Inc., submitted by Monogram
Industries, Inc., Santa Monica, Calif.; CDL:245190-A)
00076996 Berlin, C.H. (1980) Acute Oral Toxicity: Test Report No. 1-2-278362.
(Unpublished study received May 5, 1981 under 45987-1; prepared by
Bio-Technics Laboratories, Inc., submitted by Monogram Industries, Inc.,
Santa Monica, Calif.; CDL:245190-B)
00076997 Berlin, C.H. (1980) Primary Eye Irritation: Test Report No. 1-227836-3.
(Unpublished study received May 5, 1981 under 45987-1; prepared by
Bio-Technics Laboratories, Inc., submitted by Monogram Industries, Inc.,
Santa Monica, Calif.; CDL:245190-C)
00076998 Berlin, C.H. (1980) Acute Inhalation Toxicity: Test Report No. 12-27836-4.
(Unpublished study received May 5, 1981 under 459871; prepared by
Bio-Technics, Inc., submitted by Monogram Industries, Inc., Santa Monica,
Calif.; CDL:245190-D)
56
-------
BIBLIOGRAPHY
MRID
CITATION
00076999 Berlin, C.H. (1980) Primary Dermal Irritation: Test Report No. 12-27836-5.
(Unpublished study received May 5, 1981 under 459871; prepared by
Bio-Technics Laboratories, Inc., submitted by Monogram Industries, Inc.,
Santa Monica, Calif.; CDL:245190-E)
00077000 Berlin, C.H. (1980) Guinea Pig Sensitization: Test Report No. 1-227836-6.
(Unpublished study received May 5, 1981 under 459871; prepared by
Bio-Technics Laboratories, Inc., submitted by Monogram Industries, Inc.,
Santa Monica, Calif.; CDL:245190-F)
00077001 Monogram Industries, Incorporated (19??) Product Chemistry. (Unpublished
study received May 5, 1981 under 45987-1; CDL: 245189-A)
00077002 Meuly, W.C., inventor; Rhodia, Inc., assignee (1975) Process for repelling
dogs and cats from a selected area or from each other using
gamma-N-alkyl-gamma-butyrolactones and delta-Nalkyl-delta-valerolactones.
U.S. patent 3,923,997. Dec 2. 8 p. U.S. Cl. 424/279; 424/45; Int. C1.2 AOIN
9/28. (Published study; CDL:245188-A)
00077003 Monogram Industries, Incorporated (1978?) Environmental Chemistry.
(Unpublished study received May 5, 1981 under 45987-1; CDL: 245187-A)
00094682 Young, S.M. (19??) D'limonene: Fema #2633. (Unpublished study received
Jan 29, 1982 under 4758-141; prepared by Citrus & Allied Essences Ltd.,
submitted by Pet Chemicals, Inc., Miami Springs, Fla.; CDL:246738-A)
00094683 Ting, S.V.; Newhall, W.F. (1965) The Occurrence of a natural antioxident in
citrus fruit. Journal of Food Science 30(1) :57-63. (Also ~ In ~ unpublished
submission received Jan 29, 1982 under 4758-141; submitted by Pet Chemicals,
Inc., Miami Springs, Fla.; CDL:246738-B)
00094685 Cerven, D.R.; Moreno, O.M.; Altenbach, E.J. (1982) Oral Toxicity in Albino
Rats: Project No. MB 81-5736 A. (Unpublished study received Jan 29, 1982
under 4758-141; prepared by MB Research Laboratories, Inc., submitted by Pet
Chemicals, Inc., Miami Springs, Fla.; CDL:246739-A)
00094686 Cerven, D.R.; Moreno, O.M.; Altenbach, E.J. (1982) Acute Dermal Toxicity
in Albino Rabbits: Project No. MB 81-5736 B. (Unpublished study received
57
-------
BIBLIOGRAPHY
MRID
CITATION
Jan 29, 1982 under 4758-141; prepared by MB Research Laboratories, Inc.,
submitted by Pet Chemicals, Inc., Miami Springs, Fla.; CDL:246739-B)
00094687 Weatherby, S.E.; Moreno, O.M.; Altenbach, E.J. (1982) Primary Dermal
Irritation in Albino Rabbits: Project No. MB 81-5736 C. (Unpublished study
received Jan 29, 1982 under 4758-141; prepared by MB Research Laboratories,
Inc., submitted by Pet Chemicals, Inc., Miami Springs, Fla.; CDL:246739-C)
00094688 Weatherby, S.E.; Moreno, O.M.; Altenbach, E.J. (1982) Eye Irritation in
Rabbits: Project No. MB 81-5736 D. (Unpublished study received Jan 29,
1982 under 4758-141; prepared by MB Research Laboratories, Inc., submitted
by Pet Chemicals, Inc., Miami Springs, Fla.; CDL:246739-D)
00094689 Cerven, D.R.; Moreno, O.M.; Altenbach, E.J. (1982) Guinea Pig
Sensitization: Project No. MB 81-5736 F. (Unpublished study received Jan 29,
1982 under 4758-141; prepared by MB Research Laboratories, Inc., submitted
by Pet Chemicals, Inc., Miami Springs, Fla.; CDL:246739-E)
00094690 Tansy, M.F. (1981) Letter sent to Oscar M. Moreno dated Dec 29, 1981:
Inhalation toxicology report on compound 81-5736. (Unpublished study
received Jan 29, 1982 under 4758-141; prepared by MB Research Laboratories,
Inc., submitted by Pet Chemicals, Inc., Miami Springs, Fla.; CDL:246739-F)
00094691 Boyd, W.E. (1982) Efficacy Study of Citrus Shampoo on Fleas. (Unpublished
study, including letter dated Jan 17, 1982 from L.A. Bernstein to Claire
Ulanoff, received Jan 29, 1982 under 4758-141; prepared by Boyd & Doty
D.V.M. Chartered, submitted by Pet Chemicals, Inc., Miami Springs, Fla.;
CDL:246740-A)
00097972 Whitmire Research Laboratories, Incorporated (1981) Efficacy Data in Support
of Application for Amended Registration for Whitmire Wasp-stopper III.
(Compilation; unpublished study received Jul 19, 1980 under 499-215;
CDL:247107-A)
00100789 Pet Chemicals, Inc. (1982) Efficacy of Citrex Dip. (Compilation; unpublished
study received Apr 30, 1982 under 4758-142; CDL:247444-A)
58
-------
BIBLIOGRAPHY
MRID
CITATION
00100790 Cerven, D.; Moreno, 0.; Altenbach, E. (1982) Oral Toxicity in Albino Rats:
Citrex Flea & Tick Dip: Project No. MB 825844 A. (Unpublished study
received Apr 30, 1982 under 4758142; prepared by MB Research Laboratories,
Inc., submitted by Pet Chemicals, Inc., Miami Springs, FL; CDL:247445-A)
00100791 Cerven, D.; Moreno, 0.; Altenbach, E. (1982) Acute Dermal Toxicity in
Albino Rabbits: Citrex Flea and Tick Dip: Project No. MB 82-5844 B.
(Unpublished study received Apr 30, 1982 under 4758-142; prepared by MB
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MRID
CITATION
40393601 Von Genk, R. (1987) Glidco Pine Oil 80-Modified Manufacturing Procedure:
Laboratory Project ID: 80-371. Unpublished study prepared by SCM Glidco
Organics. 8 p.
40543600 Rod Products Company (1988) Submission of Efficacy Data on Doo-Not (EPA
Reg. No. 45987-1). Transmittal of 1 study.
40543601 Rod, R. (1987) Doo-Not Test Procedure TP-109B: Efficacy Tests with Cats.
Unpublished study prepared by Connie's Kitty Castle. 13 p.
40805600 Elite Chemical Corp. Inc. (1988) Submission of Chemistry and Efficacy Data in
Support of Elite d-Limonene Flea Dip. Transmittal of 1 study.
40805601 Adams, R. (1988) Elite d-Limonene Flea Dip: Product Chemistry and Efficacy
Data. Unpublished study prepared by Elite Chemical Corp. 24 p.
40805900 Elite Chemical Corp. Inc. (1988) Submission of Chemistry and Efficacy Data in
Support of Elite d-Limonene Flea Spray. Transmittal of 1 study.
40805901 Adams, R. (1988) Elite d-Limonene Flea Spray: Product Chemistry and
Efficacy Data. Unpublished study prepared by Elite Chemical Corp. 24 p.
40806100 Elite Chemical Corp. Inc. (1988) Submission of Chemistry Data in Support of
Elite d-Limonene Flea Shampoo. Transmittal of 1 study.
40806101 Adams, R. (1988) Elite d-Limonene Flea Shampoo: (Product Chemistry and
Efficacy Data). Unpublished study prepared by Elite Chemical Corp. 24 p.
41953100 Pet Chemicals/SRA International (1991) Submission of product chemistry data
in support of reregistration of D-Limonene. Transmittal of 1 study.
41953101 Commerford, J. (1991) D-Limonene: Physical and Chemical Characteristics.
Unpublished study prepared by SRA International Inc. 6 p.
41962100 Pet Chemicals/SRA International, Inc. (1991) Submission of product chemistry
data in support of reregistration of D-Limonene. Transmittal of 1 study.
41962101 Commerford, J. (1991) D-Limonene: Analysis and Certification of Product
Ingredients. Unpublished study prepared by Pet Chemicals, lip.
72
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BIBLIOGRAPHY
MRID
CITATION
42023900 Pet Chemicals (1991) Submission of Incident Report for Flea Stop Flea Spray
for Section 6(a)(2) Requirements. Transmittal of 1 study.
42023901 Williams, T. (1991) Letter sent to U.S. EPA dated September 16, 1991: Flea
Stop Flea Spray: Report of exploding cans. Prepared by Pet Chemicals. 1 p.
42024000 Pet Chemicals (1991) Submission of Incident Report Pertaining to Flea Stop
Flea Spray for Section 6(a)(2) Requirements. Transmittal of 1 study.
42024001 Williams, T. (1990) Letter Sent to U.S. EPA dated September 11, 1991: Flea
Stop Flea Spray: Report of exploding cans. Prepared by Pet Chemicals. 1 p.
42103100 Pet Chemicals (1991) Submission of 6(a)(2) data to Support the Registration of
VIP Dip: Efficacy Data. Transmittal of 1 Study.
42103101 Williams, D. (1991) Letter Sent to U.S. EPA dated November 19,1991 :
Concerning incident report from a veterninarian of VIP dip. Prepared by Pet
Chemicals. 1 p.
42136600 Pet Chemicals (1991) Submission of Incident Report on Flea Stop Dip: Risk
Exposure Study. Transmittal of 1 study.
42136601 Williams, T. (1991) Letter Sent to US EPA Registration Div. dated December
2, 1991: Concerning incident of cat treated with Flea Stop Dip. Prepared by
Pet Chemicals. 1 p.
42136800 Pet Chemicals (1991) Submission of Incident Report on Flea Stop Fogger and
Dip Sprayed over fishing area and used on cat: Risk/ Exposure Study.
Transmittal of 1 study.
42136801 Williams, T. (1991) Letter Sent to US EPA Registration Div. dated December
11, 1991: Concerning incidents of fish kill after using Flea Stop Fogger &
problems with cat after dipping with Flea Stop Dip. Prepared by Pet
Chemicals. 1 p.
42257100 Pet Chemicals (1992) Submission of Scetion 6(a)(2) Data Regarding Adverse
Effects of Flea Stop Shampoo. Transmittal of 1 study.
73
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BIBLIOGRAPHY
MRID
CITATION
42257101 Williams, D. (1992) Letter Sent to EPA dated January 6, 1992: Regarding
adverse effect of seven (7) chihuahuas after being shampooed with Flea Stop
Shampoo. Prepared by Pet Chemicals. 1 p.
42302400 Pet Chemicals (1992) Submission of FIFRA 6(a)(2) incident report concerning
Flea Stop Flea Spray. Transmittal of 1 study.
42302401 Williams, T. (1992) Letter Sent to Registration Div., EPA dated April 27,
1992: Concerning explosion of 14 oz container of Flea Stop Flea Spray.
Prepared by Pet Chemicals. 1 p.
42316300 Pet Chemicals (1992) Submission of toxicity data in support of the
reregistration of D-Limonene. Transmittal of 1 study.
42316301 Hoberman, A. (1992) Developmental Toxicity (Embryo-Fetal Toxicity and
Teratogenic Potential) Study of D-Limonene Technical Administered Orally Via
Gavage to Crl:CD BR VAF/Plus Presumed Pregnant Rats: Final Report: Lab
Project Number: 2119-001. Unpublished study prepared by Argus Research
Laboratories, Inc. 334 p.
42357400 Christal's Inc. (1992) Submission of product chemistry data to support the
registration of Australian Luxury Shampoo for Dogs (d-limonene). Transmittal
of 1 study.
42357401 Harrison, E. (1992) D-limonene: Product Identity and Composition.
Unpublished study prepared by Christal's Inc. lip.
42380700 Rod Products Comp. (1992) Submission of Product Chemistry Data in Support
of Registration for Fly, Cockroach, and Ant Killer. Transmittal of 1 study.
42380701 Rod, R. (1991) Subpart C-Product Chemistry Data Requirements: Unpublished
study prepared by Rod Products Co. 58 p.
42392900 Mr. Christal's Inc. (1992) Submission of Product Chemistry and Toxicity Data
in Support of Registration for Australian Luxury Shampoo for Dogs.
Transmittal of 17 studies.
42392901 Anthony, C. (1992) D-Limonene: Preliminary Analysis of Representative
Samples and Precision and Accuracy of Analytical Methods Used to Validate
74
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BIBLIOGRAPHY
MRID
CITATION
Certified Limits: Lab Project Number: 00355-001. Unpublished study prepared
by Case Consulting Laboratories, Inc. 17 p.
42392902 Anthony, C. (1992) D-Limonene: Physical and Chemical Properties: Lab
Project Number: 00355-001. Unpublished study prepared by Case Consulting
Laboratories, Inc. 46 p.
42392903 Harrison, E. (1992) Product Identity and Composition: Australian Luxury
Shampoo for Dogs: Unpublished study. 107 p.
42392904 Harrison, E. (1992) Australian Luxury Shampoo for Dogs: Analysis and
Certification of Product Ingredients. Unpublished study, lip.
42392905 Anthony, C. (1992) Dog Shampoo Physical and Chemical Properties: Lab
Project Number: 00355-001. Unpublished study prepared by Case Consulting
Laboratories, Inc. 46 p.
42392906 Cerven, D. (1992) Single Dose Oral Toxicity in Rats/LD50 in Rats: Australian
Luxury Dog Shampoo, Formula DS (CTF)-R1: Lab Project Number: MB
91-1103 A. Unpublished study prepared by MB Research Laboratories, Inc. 9
P-
42392907 Cerven, D. (1992) Acute Dermal Toxicity in Rabbits/LD50 in Rabbits:
Australian Luxury Dog Shampoo, Formula DS (CTF)-Rl: Lab Project
Number: MB 91-1103 B. Unpublished study prepared by MB Research
Laboratories, Inc. 14 p.
42392908 Werley, M. (1992) Inhalation Toxicity in Rats: Australian Luxury Dog
Shampoo, Formula DS (CTF)-Rl: Lab Project Number: MB 91-1103 E.
Unpublished study prepared by MB Research Laboratories, Inc. 33 p.
42392909 Cerven, D. (1992) Primary Eye Irritation and/or Corrosion in Rabbits:
Australian Luxury Dog Shampoo, Formula DS (CTF)-Rl: Lab Project
Number: MB 91-1103. Unpublished study prepared by MB Research
Laboratories, Inc. lip.
42392910 Cerven, D. (1992) Primary Eye Irritation and/or Corrosion in Rabbits:
Australian Luxury Dog Shampoo, Formula DS (CTF)R-4: Lab Project
Number: MB 92-1484 D. Unpublished study prepared by MB Research
75
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BIBLIOGRAPHY
MRID
CITATION
Laboratories, Inc. lip.
42392911 Cerven, D. (1992) Primary Dermal Irritation in Albino Rabbits: Australian
Luxury Dog Shampoo, Formula DS (CTF)-R1: Lab Project Number: MB
91-1103 C. Unpublished study prepared by MB Research Laboratories, Inc.
10 p.
42392912 Cerven, D. (1992) Delayed Contact Dermal Sensitization Buehler Method:
Australian Luxury Dog Shampoo, Formula DS (CTF)-Rl: Lab Project
Number: MB 91-1103 F. Unpublished study prepared by MB Research
Laboratories, Inc. 18 p.
42392913 Cerven, D. (1992) Single Dose Oral Toxicity in Rats/LD50 in Rats: Sunkist
Premium Orange Terpene (Limonene) #6098: Lab Project Number: MB
91-1104 A. Unpublished study prepared by MB Research Laboratories, Inc.
lip.
42392914 Cerven, D. (1992) Acute Dermal Toxicity in Rabbits/LD50 in Rabbits: Sunkist
Premium Orange Terpene (Limonene) #6098: Lab Project Number: MB
91-1104 B. Unpublished study prepared by MB Research Laboratories, Inc.
12 p.
42392915 Cerven, D. (1992) Primary Eye Irritation and/or Corrosion in Rabbits: Sunkist
Premium Orange Terpene (Limonene) #6098: Lab Project Number: MB
91-1104 D. Unpublished study prepared by MB Research Laboratories, Inc.
lip.
42392916 Cerven, D. (1992) Primary Dermal Irritation in Albino Rabbits: Sunkist
Premium Orange Terpene (Limonene) #6098: Lab Project Number: MB
91-1104 C. Unpublished study prepared by MB Research Laboratories, Inc.
10 p.
42392917 Cerven, D. (1992) Delayed Contact Dermal Sensitization Buehler Method:
Sunkist Premium Orange Terpene (Limonene) #6098: Lab Project Number:
MB 91-1104 F. Unpublished study prepared by MB Research Laboratories,
Inc. 18 p.
76
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BIBLIOGRAPHY
MRID
CITATION
42626200 Rod Products Co. (1993) Submission of product chemistry and efficacy data in
support of the registration of Bugchaser Insect Repellent Tablecloth.
Transmittal of 3 studies.
42626201 Rod, R. (1993) Product Chemistry: Bugchaser Insect Repellent Outdoor
Tablecloth. Unpublished study prepared by Rod Products Co. 14 p.
42626202 Rod, R. (1993) Data Requirements Tables (Subpart D): Bugchaser Insect
Repellent Strip & Bugchaser Insect Repellent Outdoor Tablecloth. Unpublished
study prepared by Rod Products Co. 8 p.
42626203 Rod, R. (1992) Efficacy Studies: Insect Repellents/Feeding Depressants.
Unpublished study prepared by Rod Products Co. 11 p.
42626300 Rod Products Co. (1993) Submission of product chemistry and efficacy data in
support of the registration of Bugchaser Insect Repellent Strip. Transmittal of 3
studies.
42626301 Rod, R. (1993) Product Chemistry: Bugchaser Insect Repellent Strip.
Unpublished study prepared by Rod Products Co. 14 p.
42626302 Rod, R. (1993) Data Requirements Tables (Subpart D): Bugchaser Insect
Repellent Strip & Bugchaser Insect Repellent Outdoor Tablecloth. Unpublished
study prepared by Rod Products Co. 8 p.
42626303 Rod, R. (1992) Efficacy Studies: Insect Repellents/Feeding Depressants.
Unpublished study prepared by Rod Products Co. 7 p.
42678104 Kuhn, J. (1993) Rodspray: Acute Dermal Toxicity Study in Rabbits: Lab
Project Number: 9684-92. Unpublished study prepared by Stillmeadow, Inc.
lip.
42694200 Mr. Christal's (1993) Submission of toxicity data in support of the Limonene
reregistration. Transmittal of 1 study.
42694201 Jameson, C. (1983) NTP Technical Report on the Toxicology and
Carcinogenesis Studies of d-Limonene in F344/N Rats and B6C3F Mice.
Prepared by Mr. Christal's Inc.; available from the National Institutes of
Health, Public Health Service, NIH Publication No. 90-2802. 168 p.
77
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BIBLIOGRAPHY
MRID
CITATION
42726600 Mr. Christal's Inc. (1993) Submission of Product Chemistry and Toxicity Data
in Support of Registration Australian Luxury Shampoo for Dogs. Transmittal
of 5 Studies.
42726601 Cervin, D. (1993) Delayed Contact Dermal Sensitization Test (Buehler
Method): Australian Luxury Dog Shampoo, Formula DS (CTF)-Rl: Amended
Final Report: Lab Project Number: MB 91-1104 F. Unpublished study
prepared by MB Research Laboratories, Inc. 18 p.
42726602 Cervin, D. (1993) Delayed Contact Dermal Sensitization Test (Buehler
Method): Sunkist Premium Orange Terpene (Limonene): Amended Final
Report: Lab Project Number: MB 91-1103 F. Unpublished study prepared by
MB Research Laboratories, Inc. 18 p.
42726603 Moreno, M. (1993) Inhalation Toxicity in Rats: Australian Luxury Dog
Shampoo, formula DS (CTF)-Rl: Amended Final Report: Lab Project Number:
MB 91-1103 E. Unpublished study prepared by MB Research Laboratories,
Inc. 33 p.
42726604 Anthony, C. (1993) Mr. Christal's Australian Luxury Dog Shampoo: Physical
and Chemical Properties: Lab Project Number: 00425-001. Unpublished study
prepared by Case Consulting Laboratories, Inc. 15 p.
42726605 Harrison, E. (1993) Addendum to MRID# 42392903: Mr. Christal's Australian
Luxury Shampoo for Dogs: Beginning Materials and Discussion of Impurity
Formation. Unpublished study prepared by Mr. Christal's. 19 p.
42864100 Rod Products Co. (1993) Submission of efficacy data in support of registration
for Bugchaser Insect Repellent Strip. Transmittal of 1 study.
42864101 Rod, R. (1993) Efficacy Studies: Various Rodspray Products. Unpublished
study prepared by Rod Products Co. 14 p.
43011900 Applied Biochemists, Inc. (1993) Submission of Product Chemistry and Acute
Toxicology Data in Support of Pond and Lake Algaecide Product Clearigate.
Transmittal of 7 studies.
78
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BIBLIOGRAPHY
MRID
CITATION
43011901 Anthony, C. (1993) Enhanced Cutrine: Physical and Chemical Properties: Lab
Project Number: 00408-001. Unpublished study prepared by Case Consulting
Labs, Inc. 39 p.
43011902 Anthony, C. (1993) Enhanced Cutrine: Storage Stability: Lab Project Number:
00428-001. Unpublished study prepared by Case Consulting Labs, Inc. 21 p.
43011903 Shapiro, R. (1993) EPA Acute Dermal Toxicity-Defined LD50 (in Rabbits of
Enhanced Cutrine): Lab Project Number: T-1964. Unpublished study prepared
by Product Safety Labs. 23 p.
43011904 Shapiro, R. (1993) EPA Acute Inhalation-Defined LC50 (in Rats of Enhanced
Cutrine): Lab Project Number: T-1966. Unpublished study prepared by
Product Safety Labs. 40 p.
43011905 Shapiro, R. (1993) EPA Primary Dermal Irritation Test (in Rabbits of
Enhanced Cutrine): Lab Project Number: T-1963. Unpublished study prepared
by Product Safety Labs. 17 p.
43011906 Shapiro, R. (1993) EPA Guinea Pig Sensitization Test (Buehler) (of Enhanced
Cutrine): Lab Project Number: T-1965. Unpublished study prepared by
Product Safety Labs. 23 p.
43011907 Kierkowski, D. (1993) Product Chemistry Series 61 (of Cleargate): Lab Project
Number. Unpublished study prepared by Applied Biochemists, Inc. 9 p.
43013700 Rod Products Co. (1993) Submission of Efficacy Data in Support of
Application for Registration of BUGCHASER Insect Repellent Strip.
Transmittal of 1 Study.
43013701 Vargo, A. (1993) Efficacy Study: Bugchaser Wrist Band Insect Repellent Strip.
Unpublished study prepared by American Samoa Community College. 5 p.
43107700 Speer Products, Inc. (1994) Submittal of Product Chemistry Data in Support of
Reregistration of Limonene. Transmittal of 1 study.
43107701 Rondon, C. (1994) Stability of d-Limonene Technical: Final Report: Lab
Project Number: 93-6411-11. Unpublished study prepared by Arctech, Inc. 44
P-
79
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BIBLIOGRAPHY
MRID
CITATION
43117000 Speer Products (1994) Submission of toxicology data in support of FIFRA
6(a)(2) requirements for d-limonene. Transmittal of 1 study.
43117001 Lewis, E. (1994) Letter Sent to R. Mountfort dated January 21, 1994: (Dermal
Irritation and Ulceration in 2-week Dermal Range Finding Test: d-Limonene).
Prepared by Pazianos Associates for Speer Products, Inc. 37 p.
43182700 Mr. Christal's, Inc. (1994) Submittal of Skin Sensitization Data in Support of
Registration of Christal's Australian Luxury Shampoo for Dogs. Transmittal of
2 studies.
43182701 Chmura, P. (1994) Delayed Contact Dermal Sensitization Test (Buehler
Method): Australian Dog Shampoo, DS (CTF) R-5, Lot #ALS-54, 5.07%
Limonene: Lab Project Number: MB 93-3128 F. Unpublished study prepared
by MB Research Laboratories, Inc. 24 p.
43182702 Chmura, P. (1994) Delayed Contact Dermal Sensitization Test (Buehler
Method): Sunkist Essential Oils, Premium Orange Terpenes, Lot #61983,
98.55% Limonene: Lab Project Number: MB 93-3290 F. Unpublished study
prepared by MB Research Laboratories, Inc. 23 p.
93136000 Pazianos Associates (1990) Reregistration Phase 3 Response: Limonene.
93136001 Damico, J. (1990) Pazianos Associates Phase 3 Summary of MRID 00150435
and Related MRIDs 00152930. D-Limonene Product Chemistry Data. 12 p.
93136002 Damico, J. (1990) Pazianos Associates Phase 3 Summary of MRID 00150435.
D-Limonene Product Chemistry Data: Chemical and Physical Properties. 5 p.
93136003 Smith, F. (1990) Pazianos Associates Phase 3 Summary of MRID 00146988.
A Dietary LC50 Study in the Bobwhite with d-Limonene. Prepared by Wildlife
International, Ltd. 6 p.
93136004 Smith, F. (1990) Pazianos Associates Phase 3 Summary of MRID 00146085.
A 96-hour Static Bioassay in Rainbow Trout with d-Limonene. Prepared by
Environmental & Toxicological Consultants, Inc. 6 p.
80
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BIBLIOGRAPHY
MRID
CITATION
93136005 Smith, F. (1990) Pazianos Associates Phase 3 Summary of MRID 00146085.
A 48-hour Static Bioassay in Daphnia magna with d-Limonene. Prepared by
Environmental & Toxicological Consultants, Inc. 6 p.
93136006 Smith, F. (1990) Pazianos Associates Phase 3 Summary of MRID 00150437.
Acute Oral Toxicity Study in Rats: d-Limonene. Prepared by Cosmopolitan
Safety Evaluation, Inc. 6 p.
93136007 Smith, F. (1990) Pazianos Associates Phase 3 Summary of MRID 00150436.
Acute Dermal Toxicity in the Rabbit: d-Limonene. Prepared by Cosmopolitan
Safety Evaluation, Inc. 6 p.
93136008 Smith, F. (1990) Pazianos Associates Phase 3 Summary of MRID 00150433.
Acute Inhalation Toxicity in the Rat: d-Limonene. Prepared by Cosmopolitan
Safety Evaluation, Inc. 5 p.
93136009 Smith, F. (1990) Pazianos Associates Phase 3 Summary of MRID 00150431.
Primary Eye Irritation Study in Rabbits: d-Limonene. Prepared by
Cosmopolitan Safety Evaluation, Inc. 5 p.
93136010 Smith, F. (1990) Pazianos Associates Phase 3 Summary of MRID 00150432.
Primary Dermal Irritation Study in Rabbits: d-Limonene. Prepared by
Cosmopolitan Safety Evaluation, Inc. 6 p.
93136011 Smith, F. (1990) Pazianos Associates Phase 3 Summary of MRID 00150434.
Dermal Sensitization in the Guinea Pig: d-Limonene. Prepared by
Cosmopolitan Safety Evaluation, Inc. 5 p.
93136999 Pazianos Associates (1990) Reregistration Phase 3 Response: Limonene.
Correspondence and Supporting Material.
93137000 Rod Products Company (1990) Reregistration Phase 3 Response: Limonene.
93137001 Rod, R. (1990) Rod Products Company Phase 3 Summary of MRID 00077001
and Related MRIDs 00077002, 00077003. (Product Identity: Doo-Not). 7 p.
81
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BIBLIOGRAPHY
MRID
CITATION
93137002 Rod, R. (1990) Rod Products Company Phase 3 Summary of MRID 00109340.
Acute Avian Oral: Quail: No-Go Dog Repellent: ABSL No. 18766. Prepared
by Applied Biological Sciences Laboratory, Inc. lip.
93137003 Rod, R. (1990) Rod Products Company Phase 3 Summary of MRID 00109342.
Acute Avian Diet.: Quail: No-Go Dog Repellent: ABSL No. 18866. Prepared
by Applied Biological Sciences Laboratory, Inc. 12 p.
93137004 Rod, R. (1990) Rod Products Company Phase 3 Summary of MRID 00109341.
Acute Avian Diet.: Duck: No-Go Dog Repellent: ABSL No. 18866. Prepared
by Applied Biological Sciences Laboratory, Inc. 12 p.
93137005 Rod, R. (1990) Rod Products Company Phase 3 Summary of MRID 00109344.
Fish Toxicity Fathead Minnows: No-Go Dog Repellent: ABSL No. 18766.
Prepared by Applied Biological Sciences Laboratory, Inc. lip.
93137006 Rod, R. (1990) Rod Products Company Phase 3 Summary of MRID 00109343.
Fish Toxicity Rainbow Trout: No-Go Dog Repellent: ABSL No. 18766.
Prepared by Applied Biological Sciences Laboratories, Inc. lip.
93137007 Rod, R. (1990) Rod Products Company Phase 3 Summary of MRID 00109345.
Invertebrate Toxicity: No-Go Dog Repellent: ABSL No. 18766. Prepared by
Applied Biological Sciences Laboratories, Inc. lip.
93137008 Rod, R. (1990) Rod Products Company Phase 3 Summary of MRID 00109339.
Acute Oral Toxicity Rat: Monogram Animal Repellant No. 100: Test Report
No. 1-2-27836-2. Prepared by Bio-Technics Laboratories, Inc. 8 p.
93137009 Rod, R. (1990) Rod Products Company Phase 3 Summary of MRID 00109339.
Acute Dermal Toxicity Rabbit...Monogram Animal Repellant No. 100: Test
Report No. 1-2-27836-1. Prepared by Bio-Technics Laboratories, Inc. 8 p.
93137010 Rod, R. (1990) Rod Products Company Phase 3 Summary of MRID 00109339.
Acute Inhalation Toxicity Rat: Monogram Animal Repellant No. 100: Test
Report No. 1-2-27836-4. Prepared by Bio-Technics Laboratories, Inc. 8 p.
82
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BIBLIOGRAPHY
MRID
CITATION
93137011 Rod, R. (1990) Rod Products Company Phase 3 Summary of MRID 00109339.
Primary Eye Irritation Rabbit: Monogram Animal Repellant No. 100: Test
Report No. 1-2-27836-3. Prepared by Bio-Technics Laboratories, Inc. 8 p.
93137012 Rod, R. (1990) Rod Products Company Phase 3 Summary of MRID 00109339.
Primary Dermal Irritation: Monogram Animal Repellant No. 100: Test Report
No. 1-2-27836-5. Prepared by Bio-Technics Laboratories, Inc. 9 p.
93137013 Rod, R. (1990) Rod Products Company Phase 3 Summary of MRID 00109339.
Dermal Sensitization: Monogram Animal Repellant No. 100: Test Report No.
1-2-27836-6. Prepared by Bio-Technics Laboratories, Inc. 8 p.
93137999 Rod Products Company (1990) Reregistration Phase 3 Response: Limonene.
Correspondence and Supporting Material.
93280000 Mr. Cristal's (1993) Reregistration Phase 3 Response: d-Limonene.
93280999 Mr. Cristal's (1993) Reregistration Phase 3 Response: d-Limonene.
Correspondence and Supporting Material.
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APPENDIX D. List of Available Related Documents
85
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86
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The following is a list of available documents related to Limonene. It's purpose is to
provide a path to more detailed information if it is needed. These accompanying documents
are part of the Administrative Record for Limonene 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. Limonene RED Fact Sheet
4. PR Notice 86-5 (included in this appendix)
5. PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient
Statement
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APPENDIX E. PR Notices 86-5 and 91-2
89
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90
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PR Notice 86-5
91
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92
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I UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
/""Pno1t° WASHINGTON, B.C. 20460
July 29, 1986
OFFICE OF
PR NOTICE 86-5 PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
NOTICE TO PRODUCERS, FORMULATORS, DISTRIBUTORS
AND REGISTRANTS
Attention: Pers9ns responsible for Federal registration of
pesticides.
Subject: Standard format for data submitted under the
Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) and certain provisions of the Federal
Food, Drug, and Cosmetic Act (FFDCA).
I. Purpose
To require data to be submitted to the Environmental
Protection Agency (EPA) in a standard format. This Notice also
provides additional guidance about, and illustrations of, the
required formats.
II. Applicability
This PR Notice applies to all data that are submitted to EPA
to satisfy data requirements for granting or maintaining
pesticide registrations, experimental use permits, tolerances,
and related approvals under certain provisions of FIFRA and
FFDCA. These data are defined in FIFRA §10(d)(1). This Notice
does not apply to commercial, financial, or production
information, which are, and must continue to be, submitted
differently under separate cover.
Ill. Effective Date
This notice is effective on November 1, 1986. Data formatted
according to this notice may be submitted prior to the effective
date. As of the effective date, submitted data packages that do
not conform to these requirements may be returned to the
submitter for necessary revision.
IV. Background
On September 26, 1984, EPA published proposed regulations in
the Federal Register (49 FR 37956) which include Requirements for
Data Submission (40 CFR §158.32), and Procedures for Claims of
Confidentiality of Data (40 CFR §158.33). These regulations
specify the format for data submitted to EPA under Section 3 of
FIFRA and Sections 408 and 409 of FFDCA, and procedures which
must be followed to make and substantiate claims of confiden-
tiality. No entitlements to data confidentiality are changed,
either by the proposed regulation or by this notice.
OPP is making these requirements mandatory through this
Notice to gain resource-saving benefits from their use before the
93
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entire proposed regulation becomes final. Adequate lead time is
being provided for submitters to comply with the new
requirements.
V. Relationship of this Notice to Other OPP Policy and Guidance
While this Notice contains requirements for organizing and
formatting submittals of supporting data, it does not address the
substance of test reports themselves. "Data reporting" guidance
is now under development in OPP, and will specify how the study
objectives, protocol, observations, findings, and conclusions are
organized and presented within the study report. The data
reporting guidance will be C9mpatible with submittal format
requirements described in this Notice.
OPP has also promulgated a policy (PR Notice 86-4 dated
April 15, 1986) that provides for early screening of certain
applications for registration under FIFRA §3. The objective of
the screen is to avoid the additional C9sts and prolonged delays
associated with handling significantly incomplete application
packages. As of the effective date of this Notice, the screen
will include in its criteria for acceptance of applicati9n
packages the data formatting requirements described herein.
OPP has also established a public docket which imposes
deadlines for inserting int9 the docket documents submitted in
connection with Special Reviews and Registration Standards (see
40 CFR §154.15 and §155.32). To meet these deadlines, OPP is
requiring an additional copy of any data submitted to the docket.
Please refer to Page 10 for more information about this
requirement.
For several years, OPP has required that each application
for registration or other action include a list 9f all applicable
data requirements and an indication of how each is satisfied--the
statement of the method of support f9r the application.
Typically, many requirements are satisfied by reference to data
previously submitted--either by the applicant or by another
party. That requirement is not altered by this notice, which
applies only to data submitted with an application.
VI. Format Requirements
A more detailed discussion of these format requirements
foll9ws the index on the next page, and samples of some of the
requirements are attached. Except for the language 9f the two
alternative forms of the Statement of Data Confidentiality Claims
(shown in Attachment 3) which cannot be altered, these samples
are illustrative. As long as the required information is
included and clearly identifiable, the form of the samples may be
altered to reflect the submitter's preference.
- INDEX-
Text Example
Page Page
A. Organization of the Submittal Package 3 17
B. Transmittal Document 4 11
C. Individual Studies 4
C. 1 Special Considerations for Identifying Studies . . 5
D. Organization of each Study Volume 6 17
D. 1 Study Title Page 7 12
94
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D. 2 Statement of Data Confidentiality Claims
(based on FIFRA §10 (d) (1)1 8 13
D. 3 Confidential Attachment 8 15
D. 4 Supplemental Statement of Data Confidentiality
Claims (other than those based on FIFRA §10(d)(1) ) 8 14
D. 5 Good Laboratory Practice Compliance Statement . . 9 16
E. Reference to Previously Submitted Data 9
F. Physical Format Requirements & Number of Copies .... 9
G. Special Requirements for Submitting Data to the Docket 10
A. Organization of Submittal Package
A "submittal package" consists of all studies submitted at
the same time f9r review in support of a single regulatory
action, along with a transmittal document and other related
administrative material (e.g. the method of support statement,
EPA Forms 8570-1, 8570-4, 8570-20, etc.) as appropriate.
Data submitters must organize each submittal package as
described in this Notice. The transmittal and any other admin-
istrative material must be grouped together in the first physical
volume. Each study included in the submittal package must then
be bound separately.
Submitters sometimes provide additional materials that are
intended to clarify, emphasize, or otherwise comment to help
Product Managers and reviewers better understand the submittal.
If such materials relate to one study, they should be
included as an appendix to that study.
- If such materials relate to more than one study (as for
example a summary of all studies in a discipline) or to the
submittal in general, they must be included in the submittal
package as a separate study (with title page and statement
of confidentiality claims).
B. Transmittal Document
The first item in each submittal package must be a trans-
mittal document. This document identifies the submitter or all
joint submitters; the regulatory action in support of which the
package is being submitted--!.e., a registration application,
petition, experimental use permit (EUPT, §3(c)(2)(B) data
call-in, §6(a)(2) submittal, 9r a special review; the transmittal
date; and a list of all individual studies included in the
gackage in the order of their appearance, showing (usually by
uideline reference number) the data requirement(s) addressed by
each one. The EPA-assigned number for the regulatory action
(e.g. the registration, EUP, or tolerance petition number) should
be included in the transmittal document as well, if it is known
to the submitter. See Attachment 1 for an example of an
acceptable transmittal document.
The list of included studies in the transmittal of a data
submittal package supporting a registration application should be
subdivided by discipline, reflecting the order in which data
requirements appear in 40 CFR 158.
The list of included studies in the transmittal of a data
submittal package supporting a petition for tolerance or an
95
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application for an EUP should be subdivided into sections A, B,
C,.... of the petition or application, as defined in 40 CFR 180.7
and 158.125, (petitions) or Pesticide Assessment Guidelines,
Subdivision I (EUPs) as appropriate.
When a submittal package supports a tolerance petiti9n and
an application for a registration or an EUP, list the petition
studies first, then the balance of the studies. Within these two
groups of studies follow the instructions above.
C. Individual Studies
A study is the report of a single scientific investigation,
including all supporting analyses required for logical complete-
ness. A study should be identifiable and distinguishable by a
C9nventional bibliographic citation including author, date, and
title. Studies generally correspond in scope to a single Guide-
line requirement for supporting data, with 39016 exceptions dis-
cussed in section C.I. Each study included in a submittal
Eackage must be bound as a separate entity. (See comments on
inding studies on page 9.)
Each study must be consecutively paginated, beginning from
the title page as page 1. The total number of pages in the com-
plete study must be shown on the study title page. In addition
(to ensure that inadvertently separated pages can be reassociated
with the proper study during handling or review) use either of
the following:
- Include the total number of pages in the complete study on
each page (i.e., 1 of 250, 2 of 250, ...250 of 250).
- Include a company name or mark and study number on each
page of the study, e g , Company Name-1986-23. Never reuse
a study number for marking the pages of subsequent studies.
When a single study is extremely long, binding it in mul-
tiple V9lumes is permissible so long as the entire study is pag-
inated in a single series, and each volume is plainly identified
by the study title and its position in the multi-volume sequence.
C.1 Special Considerations for Identifying Studies
Some studies raise special problems in study identification,
because they address Guidelines of broader than normal scope or
for other reasons.
a. Safety Studies. Several Guidelines require testing for
safety in more than one species. In these cases each species
tested should be reported as a separate study, and bound
separately.
Extensive supplemental reports of pathology reviews, feed
analyses, historical C9ntrol data, and the like are often assoc-
iated with safety studies. Whenever possible these should be
submitted with primary reports of the study, and bound with the
primary study as appendices. When such supplemental reports are
submitted independently of the primary report, take care to fully
identify the primary report to which they pertain.
Batteries of acute toxicity tests, performed on the same end
use product and covered by a single title page, may be bound
together and reported as a single study.
b. Product Chemistry Studies. All product chemistry data
within a submittal package submitted in support of an end-use
product produced from registered manufacturing-use products
should be bound as a single study under a single title page.
Product chemistry data submitted in support of a technical
product, other manufacturing-use product, an experimental use
permit, an import tolerance petition, or an end-use product
96
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produced from unregistered source ingredients, should be bound as
a single study for each Guideline series (61, 62, and 63) for
C9nventional pesticides, or for the equivalent subject range for
biorational pesticides. The first of the three studies in a
complete product chemistry submittal for a biochemical pesticide
would cover Guidelines 151-10, 151-11, and 151-12; the second
would cover Guidelines 151-13, 151-15, and 151-16; the third
would cover Guideline 151-17. The first study for a microbial
pesticide would cover Guidelines 151-20, 151-21, and 151-22; the
second W9uld cover Guidelines 151-23 and 151-25; the third would
cover Guideline 151-26.
Note particularly that product chemistry studies are likely
to contain Confidential Business Information as defined in FIFRA
§10(d)(1)(A), (B) , or (C), and if so must be handled as described
in section D.3. of this notice.
c. Residue Chemistry Studies. Guidelines 171-4, 153-3,
and 153-4 are extremely broad in scope; studies addressing
residue chemistry requirements must thus be defined at a level
below that of the Guideline code. The general principle,
h9wever, of limiting a study to the report of a single inves-
tigation still applies fully. Data should be treated as a single
study and bound separately for each analytical method, each
report of the nature of the residue in a single crop or animal
species, and for each report of the magnitude of residues
resulting from treatment of a single crop or from processing a
single crop. When more than one commodity is derived from a
single crop (such as beet tops and beet roots) residue data on
all such C9mmodities should be reported as a single study. When
multiple field trials are associated with a single crop, all such
trials should be reported as a single study.
D.
Organization of Each Study Volume
Each complete study must include all applicable elements in
the list below, in the order indicated. (Also see Page 17.)
Several of these elements are further explained in the following
paragraphs. Entries in the column headed "example" cite the
page number of this notice where the element is illustrated.
Element
Study Title Page
Statement of Data
Confidentiality
Claims
Certification of Good
Laboratory Practice
Flagging statements
Body of Study
Study Appendices
Cover Sheet to Confi-
dential Attachment
When Required Example
Always Page 12
One of the two alternative Page 13
forms of this statement
is always required
If study reports Iaborat9ry Page 16
work subject to GLP require-
ments
For certain t9xicology studies (When
flagging requirements are finalized.)
Always - with an English language
translation if required.
At submitter's option
If CBI is claimed under FIFRA
§10 (d) (1) (A) , (B) , or (C)
CBI Attachment
Supplemental Statement
of Data Confidentiality
Claims
If CBI is claimed under FIFRA
§10 (d) (1) (A) , (B) , or (C) Page 15
Only if confidentiality is Page 14
claimed on a basis other than
FIFRA §10(d)(1)(A), (B), or (C)
97
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D.I. Title Page
A title page is always required for each submitted study,
published or unpublished. The title page must always be freely
releasable to requestors; DO NOT INCLUDE CBI ON THE TITLE PAGE.
An example of an acceptable title page is on page 12 of this
notice. The following information must appear on the title page:
a. Study title. The study title should be as descriptive as
possible It must clearly identify the substance(s) tested and
correspond to the name of the data requirement as it appears in
the Guidelines.
b. Data requirement addressed. Include on the title page the
Guideline number(s) of the specific requirement(s) addressed by
the study.
c. Author(s). Cite only individuals with primary intellectual
responsibility for the C9ntent 9f the study. Identify them
plainly as authors, to distinguish them from the performing
laboratory, study sponsor, or other names that may also appear on
the title page.
d. Study Date. The title page must include a single date for
the study. If parts of the study were performed at different
times, use only the date of the latest element in the study.
e. Performing Laboratory IdentificatJ9n. If the study reports
work done by one or more laboratories,Include on the title page
the name and address of the performing laboratory or
laboratories, and the laboratory's internal project number(s) for
the work. Clearly distinguish the laboratory's project
identifier from any other reference numbers provided by the study
sponsor or submitter.
f. Supplemental Submissions. If the study is a commentary on
or supplement to another previously submitted study, or if it
responds to EPA questions raised with respect to an earlier
study, include 9n the title page elements a. through d. for the
previ9usly submitted study, along with the EPA Master Record
Identifier (MRID) or Accession number of the earlier study if you
know these numbers. (Supplements submitted in the same submittal
package as the primary study should be appended to and bound with
the primary stuay. Do not include supplements to more than one
study under a single title page).
g. Facts of Publication. If the study is a reprint of a pub-
lished d9cument, identity on the title page all relevant facts of
publication, such as the J9urnal title, volume, issue, inclusive
page numbers, and publication date.
D.2. Statements of Data Confidentiality Claims Under FIFRA
§10(d) (1) .
Each submitted study must be accompanied by one of the two
alternative forms of the statement of Data Confidentiality Claims
specified in the proposed regulation in §158.33 (b) and (c) (See
Attachment 3). These statements apply only to claims of data
confidentiality based on FIFRA §10(d)(1)(A), (B), or (C). Use
the appropriate alternative form of the statement either to
assert a claim of §10(d)(l) data confidentiality (§158.33(b)) or
to waive such a claim (§158.33(c)). In either case, the
statement must be signed and dated, and must include the typed
name and title of the official who signs it. Do not make CBI
98
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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 t9 the Confidential
Attachment must be associated with a specific cross reference to
the page(s) in the main body of the study on which it is cited,
and with a reference to the applicable passage(s) of FIFRA
§10(d)(1) on which the confidentiality claim is based.
D.4. Supplemental Statement of Data Confidentiality Claims (See
Attachment 4)
If you wish to make a claim of confidentiality for any
)ortion of a submitted study other than described by FIFRA £
[I)(A), (B), or (C), the following provisions apply:
- The specific information to which the claim applies must
be clearly marked in the body of the study as subject to a
claim of confidentiality.
- A Supplemental Statement 9f Data Confidentiality Claims
must be submitted, identifying each passage claimed confi-
dential and describing in detail the basis for the claim.
A list of the points to address in such a statement is
included in Attachment 4 on Pg 14.
- The Supplemental Statement of Data Confidentiality Claims
must be signed and dated and must include the typed name and
title of the official who signed it.
D.5. Good Laboratory Practice Compliance Statement
This statement is required if the study contains laboratory
work subject to GLP requirements specified in 40 CFR 160. Sam-
ples of these statements are shown in Attachment 6.
E. Reference to Previously Submitted Data
DO NOT RESUBMIT A STUDY THAT HAS PREVIOUSLY BEEN SUBMITTED
FOR ANOTHER PURPOSE unless EPA specifically requests it. A copy
of the title page plus the MRID number (if known) is sufficient
to allow us t9 retrieve the study immediately for review. This
prevents duplicate entries in the Agency files, and saves you
the cost of sending more copies of the study. References to pre-
viously submitted studies smpuld not be included in the transmit-
tal document, but should be incorp9rated into the statement of
the method of support for the application.
F. Physical Format Requirements
All elements in the data submittal package must be on
uniform 8 1/2 by 11 inch white paper, printed 9n one side only in
black ink, with high contrast and good res9lution. Bindings for
individual studies must be secure, but easily removable to permit
99
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disassembly for microfilming. Check with EPA for special
instructions bef9re submitting data in any medium other than
paper, such as film or magnetic media.
Please be particularly attentive to the following points:
€ Do not include frayed or torn pages.
€ Do not include carbon copies, or copies in other than
black ink.
€ Make sure that photocopies are clear, complete, and
fully readable.
€ Do not include oversize computer printouts or fold-out
pages.
€ Do not bind any documents with glue or binding tapes.
€ Make sure that all pages of each study, including any
attachments or appendices, are present and in correct
sequence.
Number of Copies Required - All submittal packages except
those associated with a Registration Standard or Special Review
(See Part G below) must be provided In three complete, identical
copies. (The prop9sed regulati9ns specified two copies; three
are now being required to expedite and reduce the cost of
processing data into the OPP Pesticide Document Management System
and getting it into review.)
G. Special Requirements for Submitting Data to the Docket
Data submittal packages associated with a Registration Stan-
dard 9r Special Review must be provided in four C9pies, fr9m one
of which all material claimed as CBI has been excised. This
fourth copy will become part of the public docket for the RS or
SR case. If no claims of confidentiality are made for the study,
the fourth copy should be identical to the other three. When
portions of a study submitted in support of an RS or SR are
claimed as CBI, the first three copies will include the CBI
material as provided in section D of this notice. The following
special preparation is required for the fourth copy.
€ Remove the "Supplemental Statement of Data
Confidentiality Claims".
€ Remove the "Confidential Attachment".
€ Excise from the body of the study any information you
claim as confidential, even if it does not fall within
the scope of FIFRA §10(d)(1)(A), (B), or (C). Do not
close up or paraphrase text remaining after this
excision.
€ Mark the fourth copy plainly on both its cover and its
title page with the phrase "Public Docket Material -
contains no information claimed as confidential".
100
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V. For Further Information
For further information contact John Carley, Chief,
Information Services Branch, Program Management and Support
Division, (703) 305-5240.
/S/
James W. Akerman
Acting Director,
Registration Division
Attachment 1. Sample Transmittal Document
Attachment 2. Sample Title Page for a Newly Submitted Study
Attachment 3. Statements of Data Confidentiality Claims
Attachment 4. Supplemental Statement of Data Confidentiality
Claims
Attachment 5. Samples of Confidential Attachments
Attachment 6. Sample G9od Laboratory Practice Statements
Attachment 7. Format Diagrams for Submittal Packages and Studies
101
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ATTACHMENT 1
ELEMENTS TO BE INCLUDED IN THE TRANSMITTAL DOCUMENT*
1. Name and address of submitter (or all joint submitters**)
"Smith Chemical Corporation Jones Chemical Company
1234 West Smith Street -and- 5678 Wilson Blvd
Cincinnati, OH 98765 Covington, KY 56789
"Smith Chemical Corp will act as sole agent for all submitters.
2. Regulatory action in support of which this package is
submitted
Use the EPA identification number (e.g. 359-EUP-67) if you know
it. Otherwise describe the type of request (e.g. experimental
use permit, data call-in - of xx-xx-xx date).
3. Transmittal date
4. List of submitted studies
Vol 1. Administrative materials - forms, previous corres-
pondence with Project Managers, and so forth.
Vol 2. Title of first study in the submittal (Guideline
No.)
Vol n Title of nth study in the submittal (Guideline
No.)
* Applicants commonly provide this information in a tran-
smittal letter. This remains an acceptable practice so
long as all four elements are included.
* Indicate which of the J9int submitters is empowered to
act on behalf of all joint submitters in any matter
concerning data compensation or subsequent use or
release of the data.
Company Official:
Name Signature
Company Name
Company Contact:
Name Phone
102
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ATTACHMENT 2
SAMPLE STUDY TITLE PAGE FOR A NEWLY SUBMITTED STUDY
Study Title
(Chemical name) - Magnitude of Residue on Corn
Data Requirement
Guideline 171-4
Author
John C. Davis
Study Completed On
January 5, 1979
Performing Laboratory
ABC Agricultural Laboratories
940 West Bay Drive
Wilmington, CA 39897
Laboratory Project ID
ABC 47-79
Page 1 of X
(X is the total number of pages in the study)
103
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ATTACHMENT 3
STATEMENTS OF DATA CONFIDENTIALITY CLAIMS
1. No claim of confidentiality under FIFRA §10(d)(1)(A),(B), or (C).
STATEMENT OF NO DATA CONFIDENTIALITY CLAIMS
No claim of confidentiality is made for any information contained in this
study on the basis of its falling within the scope of FIFRA
6§10(d)(1)(A), (B), or (C).
Company
Company Agent: Typed Name Date:
Title Signature
2. Claim of confidentiality under FIFRA §10(d)(1)(A), (B), or (C).
Information claimed confidential on the basis of its falling within the
scope of FIFRA §10(d)(1)(A), (B), or (C) has been removed to a
confidential appendix, and is cited by cross-reference number in the body
of the study.
Company:
Company Agent: Typed Name Date:
Title Signature
STATEMENT OF DATA CONFIDENTIALITY CLAIMS
NOTE: Applicants for permanent or temporary tolerances should
note that it is OPP policy that no permanent tolerance, temporary
tolerance, or request for an emergency exemption incorporating an
analytical method, can be approved unless the applicant waives
all claims of confidentiality for the analytical method. These
analytical methods are published in the FDA Pesticide Analytical
Meth9ds Manual, and therefore cannot be claimed as confidential.
OPP implements this policy by returning submitted analytical
methods, for which confidentiality claims have been made, to the
submitter, to obtain the confidentiality waiver before they can
be processed.
104
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ATTACHMENT 4
SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
For any portion of a submitted study that is not described
by FIFRA §10(d)(1)(A), (B), or (C), but for which y9u claim
C9nfidential treatment 9n another basis, the following informa-
tion must be included within a Supplemental Statement of Data
Confidentiality Claims:
€ Identify specifically by page and line number(s) each
portion of the study for which you claim
confidentiality.
€ Cite the reasons why the cited passage qualifies for
confidential treatment.
€ Indicate the length of time--until a specific date or
event, or permanently--for which the information should
be treated as confidential.
€ Identify the measures taken to guard against undesired
disclosure of this information.
€ Describe the extent to which the information has been
disclosed, and what precautions have been taken in con-
nection with those disclosures.
€ Encl9se C9pies of any pertinent determinations of
confidentiality made by EPA, other Federal agencies, of
courts concerning this information.
€ If y9u assert that disclosure of this information would
be likely to result in substantial harmful effects to
you, describe th9se harmful effects and explain why
they should be viewed as substantial.
€ If you assert that the informati9n in voluntarily sub-
mitted, indicate whether you believe disclosure of this
information might tend to lessen the availability to
EPA of similar information in the future, and if so,
how.
105
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ATTACHMENT 5
EXAMPLES OF SEVERAL CONFIDENTIAL ATTACHMENTS
Example 1. (Confidential word or phrase that has been deleted
from the study)
CROSS REFERENCE NUMBER 1 This cross reference number is used in the study in place of the following
paragraph(s) at the indicated volume and page references.
DELETED WORDS OR PHRASE: Ethylene Glycol
PAGE LINES REASON FOR THE DELETION FIFRA REFERENCE
6 14 Identity of Inert Ingredient §10(d)(C)
28 25
100 19
Example 2. (Confidential paragraph(s) that have been deleted from the study)
CROSS REFERENCE NUMBER 5 This cross reference number is used in the study in place of the following
paragraph(s) at the indicated volume and page references.
DELETED PARAGRAPH(S):
( )
( Reproduce the deleted paragraph (s) here )
PAGE LINES REASON FOR THE DELETION FIFRA REFERENCE
20. 2-17 Description of the quality control process §10(d)(l)(C)
Example 3. (Confidential pages that have been deleted from the study)
CROSS REFERENCE NUMBER 7 This cross reference number is used in the study in place of the following
paragraph(s) at the indicated volume and page references.
DELETED PAGES (S): are attached immediately behind this page
PAGES REASON FOR THE DELETION FIFRA REFERENCE
35-41. Description of product manufacturing process §10(d)(l)(A)
106
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ATTACHMENT 6.
SAMPLE GOOD LABORATORY PRACTICE STATEMENTS
Example 1.
This study meets the requirements for 40 CFR Part 160
Submitter
Sponsor
Example 2.
This study does not meet the requirements of 40 CFR Part 160, and
differs in the following ways:
1.
2.
3.
Submitter
Sponsor
Study Director_
Example 3.
The submitter of this study was neither the sponsor of this study nor
conducted it, and does not know whether it has been conducted in
accordance with 40 CFR Part 160.
Submitter
107
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ATTACHMENT 7.
FORMAT OF THE SUBMITTAL PACKAGE
Transmittal Document
Related Administrative Materials
(e.g. Method of Support Statement, etc.)
Other materials about the submittal
(e.g., summaries of groups of studies
to aid in their review).
Studies submitted as unique
to the format below.
FORMAT OF SUBMITTED STUDIES
• Study title page.
Statement of Confidentiality Claims.
GLP and flagging* statements - as appropriate.
Body of the study, with English
language translation if required.
Appendices to the study.
Title Page of the Confidential
Attachment.
Confidential Attachment.
Supplemental Statement
of Confidentiality Claims
When flagging requirements
are finalised.
Documents which must be submitted as
appropriate to meet established requirements.
Documents submitted at submitter's option.
LEGEND
108
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PR Notice 91-2
109
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110
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
PR NOTICE 91-2
NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS,
AND REGISTRANTS OF PESTICIDES
ATTENTION: Persons Responsible for Federal Registration of
Pesticide Products.
SUBJECT: Accuracy of Stated Percentages for Ingredients
Statement
I. PURPOSE:
The purpose of this notice is to clarify the Office of
Pesticide Program's P9licy with respect to the statement of
percentages in a pesticide's label's ingredient statement.
Specifically, the amount (percent by weight) of ingredient(s)
specified in the ingredient statement on the label must be stated
as the nominal concentration of such ingredient(s), as that term
is defined in 40 CFR 158.153(1). Accordingly, the Agency has
established the nominal concentration as the only acceptable
label claim for the amount of active ingredient in the product.
II. BACKGROUND
For some time the Agency has accepted two different methods
9f identifying on the label what percentage is claimed for the
ingredient(s) contained in a pesticide. Some applicants claimed a
percentage which represented a level between the upper and the
lower certified limits. This was referred to as the nominal
concentration. Other applicants claimed the lower limit as the
percentage of the ingredient(s) that would be expected to be
present in their product at the end of the product's shelf-life.
Unfortunately, this led to a great deal of confusion among the
regulated industry, the regulators, and the consumers as to
exactly how much of a given ingredient was in a given product.
The Agency has established the nominal concentration as the only
acceptable label claim for the amount of active ingredient in the
product.
Current regulations require that the percentage listed in
the active ingredient statement be as precise as possible
reflecting go9d manufacturing practices 40 CFR 156.10(g)(5). The
certified limits required for each active ingredient are intended
to encompass any such "good manufacturing practice" variations 40
CFR 158.175(c)(3).
The upper and lower certified limits, which must be proposed
in connection with a product's registration, represent the
amounts of an ingredient that may legally be present 40 CFR
158.175. The lower certified limit is used as the enforceable
lower limit for the product composition according to FIFRA
section 12(a)(1)(C), while the nominal concentration appearing on
the label would be the routinely achieved concentration used for
calculation of dosages and dilutions.
The nominal concentration would in fact state the greatest
degree of accuracy that is warranted with respect to actual
111
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product compositi9n because the nominal concentration would be
the amount of active ingredient typically found in the product.
It is imp9rtant for registrants to note that certified
limits for active ingredients are not considered to be trade
secret information under FIFRA section 10(b). In this respect the
certified limits will be routinely provided by EPA to States for
enforcement purposes, since the nominal concentration appearing
on the label may not represent the enforceable composition for
purposes of section 12(a)(1)(C).
III. REQUIREMENTS
As described below under Unit V. " COMPLIANCE SCHEDULE," all
currently registered products as well as all applications for new
registration must comply with this Notice by specifying the
nominal C9ncentrati9n expressed as a percentage by weight as the
label claim in the ingredient(s) statement and equivalence
statements if applicable (e.g., elemental arsenic, metallic zinc,
salt of an acid). In addition, the requirement for performing
sample analyses of five or more representative samples must be
fulfilled. C9pies of the raw analytical data must be submitted
with the nominal ingredient label claim. Further information
about the analysis requirement may be found in the 40 CFR
158.170. All products are required to pr9vide certified limits
for each active, inert ingredient, impurities of toxicological
significance(i.e., upper limit(s) 9nly) and on a case by case
basis as specified by EPA. These limits are to be set based on
representative sampling and chemical analysis(i.e., quality
control) of the product.
The format of the ingredient statement must conform to 40
CFR 156-Labeling Requirements For Pesticides and Devices.
After July 1, 1997, all pesticide ingredient Statements must
be changed to nominal concentration.
IV. PRODUCTS THAT REQUIRE EFFICACY DATA
All pesticides are required to be efficacious. Therefore,
the certified lower limits may not be lower then the minimum
level to achieve efficacy. This is extremely important for
products which are intended to C9ntrol pests which threaten the
public health, e.g., certain antimicrobial and rodenticide
products. Refer to 40 CFR 153.640.
In those cases where efficacy limits have been established,
the Agency will not accept certified lower limits which are below
that level for the shelf life of the product.
V. COMPLIANCE SCHEDULE
As described earlier, the purpose of this Notice is to make
the registration process more uniform and more manageable for
both the agency and the regulated community. It is the Agency's
intention to implement the requirements of this notice as
smoothly as possible so as not to disrupt or delay the Agency's
high priority programs, i.e., reregistration, new chemical, or
fast track (FIFRA section 3(c)(3)(B). Therefore,
applicants/registrants are expected to comply with the
requirements of this Notice as follows:
(1) Beginning July 1, 1991, all new product registrations
submitted to the Agency are to comply with the
requirements of this Notice.
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(2) Registrants having products subject to reregistration
under FIFRA section 4(a) are to comply with the
requirements of this Notice when specific products are
called in by the Agency under Phase V of the
Reregistration Program.
(3) All other products/applications that are not subject to
(1) and (2) ab9ve will have until July 1, 1997, to
comply with this Notice. Such applications should note
"Conversion to Nominal Concentrations on the
application form. These types Or amendments will not be
handled as "Fast Track" applications but will be
handled as routine requests.
VI. FOR FURTHER INFORMATION
Contact Tyrone Aiken for information or questions concerning
this notice on (703) 308-7031.
/s/
Anne E. Lindsay, Director
Registration Division (H-7505C)
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APPENDIX F. Combined Generic and Product Specific
Data Call-In
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GENERIC AND PRODUCT SPECIFIC
DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the
active ingredient identified in Attachment A of this Notice, the Data Call-In Chemical Status
Sheet, to submit certain data as noted herein to the U.S. Environmental Protection Agency
(EPA, the Agency). These data are necessary to maintain the continued registration of your
product(s) containing this active ingredient. Within 90 days after you receive this Notice you
must respond as set forth in Section III below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its
Attachments 1 through 7; or
2. Why you believe you are exempt from the requirements listed in this Notice and
in Attachment 3 (for both generic and product specific data), the Requirements
Status and Registrant's Response Form, (see section III-B); or
3. Why you believe EPA should not require your submission of data in the manner
specified by this Notice (see section III-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
your product(s) subject to this Notice will be subject to suspension. We have provided a list of
all of your products subject to this Notice in Attachment 2. All products are listed on both the
generic and product specific Data Call-in Response Forms. Also included is a list of all
registrants who were sent this Notice (Attachment 6).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No.
2070-0107 and 2070-0057 (expiration date 3-31-96).
This Notice is divided into six sections and seven Attachments. The Notice itself
contains information and instructions applicable to all Data Call-In Notices. The Attachments
contain specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You are Receiving this Notice
Section II - Data Required by this Notice
Section III - Compliance with Requirements of this Notice
Section IV - Consequences of Failure to Comply with this Notice
Section V - Registrants' Obligation to Report Possible Unreasonable Adverse Effects
Section VI - Inquiries and Responses to this Notice
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
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2 - Generic Data Call-in and Product Specific Data Call-in Response Forms with
Instructions
3 - Generic Data Call-In and Product Specific Data Call-In Requirements Status
and Registrant's Response Forms with Instructions
4 - LPA Grouping or End-Use Products for Meeting Acute Toxicology Data
Requirements tor Reregistration
5 - LPA Acceptance Criteria
6 - List or Registrants Receiving This Notice
7 - Cost Share and Data Compensation Forms
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient (s) and reevaluated the
data needed to support continued registration of the subject active ingredient(s). This
reevaluation identified additional data necessary to assess the health and safety of the continued
use of products containing this active ingredient(s). You have been sent this Notice because
you have product (s) containing the subject active ingredients.
SECTION II. DATA REQUIRED BY THIS NOTICE
II-A. DATA REQUIRED
The data required by this Notice are specified in the Requirements Status and
Registrant's Response Forms: Attachment 3 (for both generic and product specific data
requirements). Depending on the results of the studies required in this Notice, additional
studies/testing may be required.
II-B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements specified
in the Requirements Status and Registrant's Response Forms (Attachment 3) within the
timeframes provided.
II-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test
standards outlined in the Pesticide Assessment Guidelines for those studies for which
guidelines have been established.
These EPA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (Telephone number:
703-487-4650).
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD recommended test standards conform to those
specified in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the
C"ECD protocols, they should be modified as appropriate so that the data generated by the
study will satisfy the requirements of 40 CFR § 158. Normally, the Agency will not extend
deadlines for complying with data requirements when the studies were not conducted in
accordance with acceptable standards. The OECD protocols are available from OECD, 2001 L
Street, N.W., Washington, D.C. 20036 (Telephone number 202-785-6323; Fax telephone
number 202-785-0350).
All new studies and proposed protocols submitted in response to this Data Call-In
Notice must be in accordance with Good Laboratory Practices [40 CFR Part 160].
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II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES ISSUED
BY THE AGENCY
Unless otherwise noted herein, this Data Call-in does not in any way supersede or
change the requirements of any previous Data Call-in (s), or any other agreements entered into
with the Agency pertaining to such prior Notice. Registrants must comply with the
requirements of all Notices to avoid issuance of a Notice of Intent to Suspend their affected
products.
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
You must use the correct forms and instructions when completing your response to this
Notice. The type of Data Call-In you must comply with (Generic or Product Specific) is
specified in item number 3 on the four Data Call-in forms (Attachments 2 and 3).
III-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for generic and product
specific data must be submitted to the Agency within 90 days after your receipt of this Notice.
Failure to adequately respond to this Notice within 90 days of your receipt will be a basis for
issuing a Notice of Intent to Suspend (NOIS) affecting your products. This and other bases for
issuance of NOIS due to failure to comply with this Notice are presented in Section IV-A and
IV-B.
III-B. OPTIONS FOR RESPONDING TO THE AGENCY
1. Generic Data Requirements
The options for responding to this Notice for generic data requirements are: (a)
voluntary cancellation, (b) delete use(s), (c) claim generic data exemption, (d) agree to satisfy
the generic data requirements imposed by this Notice or (e) request a data waiver (s).
A discussion of how to respond if you choose the Voluntary Cancellation option, the
Delete Use(s) option or the Generic Data Exemption option is presented below. A discussion
of the various options available for satisfying the generic data requirements of this Notice is
contained in Section III-C. A discussion of options relating to requests for data waivers is
contained in Section III-D.
Two forms apply to generic data requirements, one or both of which must be used in
responding to the Agency, depending upon your response. These two forms are the
Data-CalHn Response Form, and the Requirements Status and Registrant's Response Form,
(contained in Attachments Z and 3, respectively).
The Data Call-In Response Forms must be submitted as part of every response to this
Notice. The Requirements Status and Registrant's Response Forms also must be submitted if
you do not qualify for a Generic Data Exemption or are not requesting voluntary cancellation
of your registration^). Please note that the company's authorized representative is required to
sign the first page of both Data Call-in Response Forms and the Requirements Status and
Registrant's Response Forms (if this form is required) and initial any subsequent pages. The
forms contain separate detailed instructions on the response options. Do not alter the printed
material. If you have questions or need assistance in preparing your response, call or write the
contact person (s) identified in Attachment 1.
a. Voluntary Cancellation -
You may avoid the requirements of this Notice by requesting voluntary cancellation of
your product (s) containing the active ingredient that is the subject of this Notice. If you wish
to voluntarily cancel your product, you must submit completed Generic and Product Specific
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Data Call-in Response Forms (Attachment 2), indicating your election of this option.
Voluntary cancellation is item number 5 on both Data Call-In Response Form(s). If you
choose this option, these are the only forms that you are required to complete.
If you chose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice, which are contained in Section IV-C.
b. Use Deletion -
You may avoid the requirements of this Notice by eliminating the uses of your product
to which the requirements apply. If you wish to amend your registration to delete uses, you
must submit the Requirements Status and Registrant's Response Form (Attachment 3), a
completed application tor amendment, a copy of your proposed amended labeling, and all
other information required for processing the application. Use deletion is option number 7
under item 9 in the instructions for the Requirements Status and Registrant's Response Forms.
You must also complete a Data Call-In Response Form by signing the certification, item
number 8. Application forms tor amending registrations may be obtained from the
Registration Support Branch, Registration Division, Office of Pesticide Programs, EPA, by
calling (703) ~~-~
If you choose to delete the use(s) subject to this Notice or uses subject to specific data
requirements, further sale, distribution, or use of your product after one year from the due
date of your 90 day response, is allowed only if the product bears an amended label.
c. Generic Data Exemption -
Under section 3(c)(2)(D) of FIFRA, an applicant for registration of a product is
exempt from the requirement to submit or cite generic data concerning an active ingredient if
the active ingredient in the product is derived exclusively from purchased, registered pesticide
products containing the active ingredient. EPA has concluded, as an exercise of its discretion,
that it normally will not suspend the registration of a product which would qualify and
continue to qualify for the generic data exemption in section 3(c)(2)(D) of FIFRA. To qualify,
all of the following requirements must be met:
(i). The active ingredient in your registered product must be present solely because of
incorporation of another registered product which contains the subject active ingredient
and is purchased from a source not connected with you;
(ii). Every registrant who is the ultimate source of the active ingredient in your
product subject to this DCI must be in compliance with the requirements of this Notice
and must remain in compliance; and
(iii). You must have provided to EPA an accurate and current " Confidential Statement
of Formula" for each of your products to which this Notice applies.
To apply for the Generic Data Exemption you must submit a completed Data Call-in
Response Form, Attachment 2 and all supporting documentation. The Generic Data Exemption
is item number 6a on the Data Call-in Response Form. If you claim a generic data exemption
you are not required to compiete the Requirements Status and Registrant's Response Form.
Generic Data Exemption cannot be selected as an option tor responding to product specific
data requirements.
If you are granted a Generic Data Exemption, you rely on the efforts of other persons
to provide the Agency with the required data. If the registrant^) who have committed to
generate and submit the required data fail to take appropriate steps to meet requirements or are
no longer in compliance with this Data Call-In Notice, the Agency will consider that both they
and you are not compliance and will normally initiate proceedings to suspend the registrations
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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.
d. Satisfying the Generic Data Requirements of this Notice
There are various options available to satisfy the generic data requirements of this
Notice. These options are discussed in Section III-C.l. of this Notice and comprise options 1
through 6 of item 9 in the instructions for the Requirements Status and Registrant's Response
Form and item 6b on the Data Call-in Response Form, if you choose item 6b (agree to satisfy
the generic data requirements), you must submit the Data Call-in Response Form and the
Requirements Status and Registrant's Response Form as weii as any other information/data
pertaining to the option chosen to address the data requirement. Your response must be on the
forms marked "GENERIC" in item number 3.
e. Request for Generic Data Waivers.
Waivers for generic data are discussed in Section III-D.l. of this Notice and are
covered by options 8 and 9 of item 9 in the instructions for the Requirements Status and
Registrant's Response Form. If you choose one of these options, you must submit both forms
as well as any other information/data pertaining to the option chosen to address the data
requirement.
2. Product Specific Data Requirements
The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this Notice
or (c) request a data waiver (s).
A discussion of how to respond if you choose the Voluntary Cancellation option is
presented below. A discussion of the various options available for satisfying the product
specific data requirements of this Notice is contained in Section III-C.2. A discussion of
options relating to requests for data waivers is contained in Section III-D.2.
Two forms apply to the product specific data requirements one or both of which must
be used in responding to the Agency, depending upon your response. These forms are the
Data-Call-in Response Form, and the Requirements Status and Registrant's Response Form,
for product specific data (contained in Attachments 2 and 3, respectively). 1 he Data CallTn
Response Form must be submitted as part of every response to this Notice. In addition, one
copy of the Requirements Status and Registrant's Response Form also must be submitted for
each product listed on the Data Caii-ln Response Form uniess the voluntary cancellation option
is selected. Please note that the company's authorized representative is required to sign the
first page of the Data Call-In Response Form and Requirements Status and Registrant s
Response Form (if this form is required) and initial any subsequent pages. The forms contain
separate detailed instructions on the response options. Do not alter the printed material. If you
have questions or need assistance in preparing your response, call or write the contact
person(s) identified in Attachment 1.
a. Voluntary Cancellation
You may avoid the requirements of this Notice by requesting voluntary cancellation of
your product (s) containing the active ingredient that is the subject of this Notice. If you wish
to voluntarily cancel your product, you must submit a completed Data Call-In Response Form,
indicating your election of this option. Voluntary cancellation is item number b on both the
Generic and Product Specific Data Call-in Response Forms. If you choose this
option, you must complete both Data Call-In response forms. These are the only forms that
you are required to complete.
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If you choose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C.
b. Satisfying the Product Specific Data Requirements of this Notice.
There are various options available to satisfy the product specific data requirements of
this Notice. These options are discussed in Section III-C.2. of this Notice and comprise
options 1 through 6 of item 9 in the instructions for the product specific Requirements Status
and Registrant's Response Form and item numbers 7a and 7b (agree to satisfy the product
specific data requirements for an MUP or EUP as applicable) on the product specific Data
Call-in Response Form. Note that the options available for addressing product specific data
requirements differ slightly from those options for fulfilling generic data requirements.
Deletion of a use(s) and the low volume/minor use option are not valid options for fulfilling
product specific data requirements. It is important to ensure that you are using the correct
forms and instructions when completing your response to the Reregistration Eligibility
Decision document.
c. Request for Product Specific Data Waivers.
Waivers for product specific data are discussed in Section III-D.2. of this Notice and
are covered by option 7 of item 9 in the instructions for the Requirements Status and
Registrant's Response Form. If you choose this option, you must submit the Data Call-In
Response Form and the Requirements Status and Registrant's Response Form as well as any
other information/data pertaining to the option chosen to address the data requirement. Your
response must be on the forms marked "PRODUCT SPECIFIC" in item number 3.
III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
1. Generic Data
If you acknowledge on the Generic Data Call-In Response Form that you agree to
satisfy the generic data requirements (i.e. you select item number 6b), then you must select
one of the six options on the Generic Requirements Status and Registrant's Response Form
related to data production for each data requirement. Your option selection should be entered
under item number 9, "Registrant Response." The six options related to data production are
the first six options discussed under item 9 in the instructions for completing the Requirements
Status and Registrant's Response Form. These six options are listed
immediately below with information in parentheses to guide you to additional instructions
provided in this Section. The options are:
(1) I will generate and submit data within the specified timeframe (Developing
Data)
(2) I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing)
I have made offers to cost-share (Offers to Cost Share)
I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an existing
study that has been submitted but not reviewed by the Agency (Citing an
-i-i.-i. Oj_1\ OJVO
Existing Study)
Option 1. Developing Data
If you choose to develop the required data it must be in conformance with Agency
deadlines and with other Agency requirements as referenced herein and in the attachments. All
data generated and submitted must comply with the Good Laboratory Practice (GLP) rule (40
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CFR Part 160), be conducted according to the Pesticide Assessment Guidelines (PAG) and be
in conformance with the requirements of PR Notice 86-5. In addition, certain studies require
Agency approval of test protocols in advance of study initiation. Those studies for which a
protocol must be submitted have been identified in the Requirements Status and Registrant's
Response Form and/or footnotes to the form. If you wish to use a protocol which differs from
the options discussed in Section II-C of this Notice, you must submit a detailed description of
the proposed protocol and your reason for wishing to use it. The Agency may choose to reject
a protocol not specified in Section II-C. If the Agency rejects your protocol you will be
notified in writing, however, you should be aware that rejection of a proposed protocol will
not be a basis for extending the deadline for submission of data.
A progress report must be submitted for each study within 90 days from the date you
are required to commit to generate or undertake some other means to address that study
requirement, such as making an offer to cost share or agreeing to share in the cost of
developing that study. This 90-day progress report must include the date the study was or will
be initiated and, for studies to be started within 12 months of commitment, the name and
address of the laboratory(ies) or individuals who are or will be conducting the study.
In addition, if the time frame for submission of a final report is more than 1 year,
interim reports must be submitted at 12 month intervals from the date you are required to
commit to generate or otherwise address the requirement for the study. In addition to the other
information specified in the preceding paragraph, at a minimum, a brief description of current
activity on and the status of the study must be included as well as a full
description of any problems encountered since the last progress report.
The time frames in the Requirements Status and Registrant's Response Form are the
time frames that the Agency is allowing for the submission of completed study reports or
protocols. The noted deadlines run from the date of the receipt of this Notice by the registrant.
If the data are not submitted by the deadline, each registrant is subject to receipt of a Notice of
Intent to Suspend the affected registration(s).
If you cannot submit the data/reports to the Agency in the time required by this Notice
and intend to seek additional time to meet the requirements(s), you must submit a request to
the Agency which includes: (1) a detailed description of the expected difficulty and (2) a
proposed schedule including alternative dates for meeting such requirements on a step-by-step
basis. You must explain any technical or laboratory difficulties and provide documentation
from the laboratory performing the testing. While EPA is considering your request, the
original deadline remains. The Agency will respond to your request in writing. If EPA does
not grant your request, the original deadline remains. Normally, extensions can be requested
only in cases of extraordinary testing problems beyond the expectation or control of the
registrant. Extensions will not be given in submitting the 90-day responses. Extensions will
not be considered if the request for extension is not made in a timely fashion; in no event shall
an extension request be considered if it is submitted at or after the lapse of the subject
deadline.
Option 2. Agreement to Share in Cost to Develop Data
If you choose to enter into an agreement to share in the cost of producing the required
data but will not be submitting the data yourself, you must provide the name of the registrant
who will be submitting the data. You must also provide EPA with documentary evidence that
an agreement has been formed. Such evidence may be your letter offering to join in an
agreement and the other registrant's acceptance of your offer, or a written statement by the
parties that an agreement exists. The agreement to produce the data need not specify all of the
terms of the final arrangement between the parties or the mechanism to resolve the terms.
Section 3(c)(2)(B) provides that if the parties cannot resolve the terms of the agreement they
may resolve their differences through binding arbitration.
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Option 3. Offer to Share in the Cost of Data Development
If you have made an offer to pay in an attempt to enter into an agreement or amend an
existing agreement to meet the requirements of this Notice and have been unsuccessful, you
may request EPA (by selecting this option) to exercise its discretion not to suspend your
registration(s), although you do not comply with the data submission requirements of this
Notice. EPA has determined that as a general policy, absent other relevant considerations, it
will not suspend the registration of a product of a registrant who has in good faith sought and
continues to seek to enter into a joint data development/cost sharing program, but the other
registrant^) developing the data has refused to accept the offer. To qualify for this option, you
must submit documentation to the Agency proving that you have made an offer to another
registrant (who has an obligation to submit data) to share in the burden of developing that
data. You must also submit to the Agency a completed EPA Form 8570-32, Certification of
Offer to Cost Share in the Development of Data, Attachment 7. In addition, you must
demonstrate that the other registrant to whom the offer was made has not accepted your offer
to enter into a cost-sharing agreement by including a copy of your offer and proof of the other
registrant's receipt of that offer (such as a certified mail receipt). Your offer must, in addition
to anything else, offer to share in the burden of producing the data upon terms to be agreed to
or, failing agreement, to be bound by binding arbitration as provided by FIFRA section
3(c)(2)(Bj(iii) and must not qualify this offer. The other registrant must also inform EPA of its
election of an option to develop and submit the data required by this Notice by submitting a
Data Call-In Response Form and a Requirements Status and Registrant's Response Form
committing to develop and submit the data required by this Notice.
In order for you to avoid suspension under this option, you may not withdraw your
offer to share in the burden of developing the data. In addition, the other registrant must fulfill
its commitment to develop and submit the data as required by this Notice. If the other
registrant fails to develop the data or for some other reason is subject to suspension, your
registration as well as that of the other registrant normally will be subject to initiation of
suspension proceedings, unless you commit to submit, and do submit, the required data in the
specified time frame. In such cases, the Agency generally will not grant a time extension for
submitting the data.
Option 4. Submitting an Existing Study
If you choose to submit an existing study in response to this Notice, you must
determine that the study satisfies the requirements imposed by this Notice. You may only
submit a study that has not been previously submitted to the Agency or previously cited by
anyone. Existing studies are studies which predate issuance of this Notice. Do not use this
option if you are submitting data to upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the
required date of submission. The Agency may determine at any time that a study is not valid
and needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly Met:
a. You must certify at the time that the existing study is submitted that the raw
data and specimens from the study are available for audit and review and you
must identify where they are available. This must be done in accordance with
the requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR
Part 160. As stated in 40 CFR 160.3 'Raw data' means any laboratory
worksheets, records, memoranda, notes, or exact copies thereof, that are the
result of original observations and activities of a study and are necessary for the
reconstruction and evaluation of the report of that study. In the event that exact
transcripts of raw data have been prepared (e.g., tapes which have been
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transcribed verbatim, dated, and verified accurate by signature), the exact copy
or exact transcript may be substituted for the original source as raw data. 'Raw
data' may include photographs, microfilm or microfiche copies, computer
printouts, magnetic media, including dictated observations, and recorded data
from automated instruments." The term "specimens", according to 40 CFR
160.3, means "any material derived from a test system for examination or
analysis."
b. Health and safety studies completed after May 1984 also must also contain all
GLP-required quality assurance and quality control information, pursuant to the
requirements or 40 CFR Part 160. Registrants also must certify at the time of
submitting the existing study that such GLP information is available for post
May 1984 studies by including an appropriate statement on or attached to the
study signed by an authorized official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3
Technical Guidance and that the study has been conducted according to the
Pesticide Assessment Guidelines (PAG) or meets the purpose of the PAG (both
available from NTIS). A study not conducted according to the PAG may be
submitted to the Agency for consideration if the registrant believes that the
study clearly meets the purpose of the PAG. The registrant is referred to 40
CFR 158.70 which states the Agency's policy regarding acceptable protocols. If
you wish to submit the study, you must, in addition to certifying that the
purposes of the PAG are met by the study, clearly articulate the rationale why
you believe the study meets the purpose of the PAG, including copies of any
supporting information or data. It has been the Agency's experience that studies
completed prior to January 1970 rarely satisfied the purpose of the PAG and
that necessary raw data usually are not available for such studies.
If you submit an existing study, you must certify that the study meets all requirements
of the criteria outlined above.
If EPA has previously reviewed a protocol for a study you are submitting, you must
identify any action taken by the Agency on the protocol and must indicate, as part of your
certification, the manner in which all Agency comments, concerns, or issues were addressed
in the final protocol and study.
If you know of a study pertaining to any requirement in this Notice which does not
meet the criteria outlined above but does contain factual information regarding unreasonable
adverse effects, you must notify the Agency of such a study. If such study is in the Agency's
files, you need only cite it along with the notification. If not in the Agency's files, you must
submit a summary and copies as required by PR Notice 86-5.
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Option 5. Upgrading a Study
If a study has been classified as partially acceptable and upgradeable, you may submit
data to upgrade that study. The Agency will review the data submitted and determine if the
requirement is satisfied. If the Agency decides the requirement is not satisfied, you may still
be required to submit new data normally without any time extension. Deficient, but
upgradeable studies will normally be classified as supplemental. However, it is important to
note that not all studies classified! as supplemental are upgradeable. If you have questions
regarding the classification of a study or whether a study may be upgraded, call or write the
contact person listed in Attachment 1. If you submit data to upgrade an existing study you
must satisfy or supply information to correct all deficiencies in the study identified by EPA.
You must provide a clearly articulated rationale" of how the deficiencies have been remedied or
corrected and why the study should be rated as acceptable to EPA. Your submission must also
specify the MRID number (s) of the study which you are attempting to upgrade and must be in
conformance with PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a study classified as
unacceptable and determined by the Agency as not capable of being upgraded.
This option also should be used to cite data that has been previously submitted to
upgrade a study, but has not yet been reviewed by the Agency. You must provide the MRID
number of the data submission as well as the MRID nurriber of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4 above, apply to
all data submissions intended to upgrade studies. Additionally, your submission of data
intended to upgrade studies must be accompanied by a certification that you comply with each
of those criteria, as well as a certification regarding protocol compliance with Agency
requirements.
Option 6. Citing Existing Studies
If you choose to cite a study that has been previously submitted to EPA, that study
must have been previously classified by EPA as acceptable, or it must be a study which has
not yet been reviewed by the Agency. Acceptable toxicology studies generally will have been
classified as "core-guideline" or "core-minimum." For ecological effects studies, the
classification generally would be a rating of "core." For all other disciplines the classification
would be "acceptable." With respect to any studies for which you wish to select this option,
you must provide the MRID number of the study you are citing and, if the study has been
reviewed by the Agency, you must provide the Agency's classification of the study.
If you are citing a study of which you are not the original data submitter, you must
submit a completed copy of EPA Form 8570-31, Certification with Respect to Data
Compensation Requirements.
2. Product Specific Data
If you acknowledge on the product specific Data Call-in Response Form that you agree
to satisfy the product specific data requirements (i.e. you select option (a or Yb), then you
must select one of the six options on the Requirements Status and Registrant's Response Form
related to data production for each data requirement. Your option selection should be entered
under item number 9, "Registrant Response." The six options related to data production are
the first six options discussed under item 9 in the instructions for completing the Requirements
Status and Registrant's Response Form. These six options are listed immediately below with
information in parentheses to guide registrants to additional instructions provided in this
Section. The options are:
(1) I will generate and submit data within the specified time-frame (Developing
Data)
(2) I have entered into an agreement with one or more registrants to develop data
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(Cost Sharing)
1 have made offers to cost-share (Offers to Cost Share)
I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an existing
study that has been
submitted but not reviewed by the Agency (Citing an Existing Study)
Option 1. Developing Data — The requirements for developing product specific data are the
same as those described for generic data (see Section III.C.I, Option 1) except that normally
no protocols or progress reports are required.
Option 2. Agree to Share in Cost to Develop Data — If you enter into an agreement to cost
share, the same requirements apply to product specific data as to generic data (see Section
III.C.I, Option 2). However, registrants may only choose this option for acute toxicity data
and certain efficacy data and only if EPA has indicated in the attached data tables that your
product and at least one other product are similar for purposes of depending on
the same data. If this is the case, data may be generated for just one of the products in the
group. The registration number of the product for which data will be submitted must be noted
in the agreement to cost share by the registrant selecting this option.
Option 3. Offer to Share in the Cost of Data Development —The same requirements for
generic data (Section lll.C.l., Option 3) apply to this option. This option only applies to acute
toxicity and certain efficacy data as described in option 2 above.
Option 4. Submitting an Existing Study — The same requirements described for generic data
(see Section lll.C.l" Option 4) apply to this option for product specific data.
Option 5. Upgrading a Study — The same requirements described for generic data (see Section
lll.C.l., Option b) apply to this option for product specific data.
Option 6. Citing Existing Studies — The same requirements described for generic data (see
Section lll.C.l" Option 6) apply to this option for product specific data.
Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-In Response Form and the
Requirements Status and Registrant's Response Form, and in the generic data requirements
section (lll.C.l.), as appropriate.
III-D REQUESTS FOR DATA WAIVERS
1. Generic Data
There are two types of data waiver responses to this Notice. The first is a request for a
low volume/minor use waiver and the second is a waiver request based on your belief that the
data requirement(s) are not appropriate for your product.
a. Low Volume/Minor Use Waiver
Option 8 under item 9 on the Requirements Status and Registrant's Response
Form. Section 3(c)(2)(A) of FIFRA requires EPA to consider the appropriateness of
requiring data for low volume, minor use pesticides. In implementing this provision,
EPA considers low volume pesticides to be only those active ingredients whose total
production volume for all pesticide registrants is small. In determining whether to grant
a low volume, minor use waiver, the Agency will consider the extent, pattern and
volume of use, the economic incentive to conduct the testing, the importance of the
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pesticide, and the exposure and risk from use of the pesticide. If an active ingredient is
used for both high volume and low volume uses, a low volume exemption will not be
approved. If all uses of an active ingredient are low volume and the combined volumes
for all uses are also low, then an exemption may be granted, depending on review of
other information outlined below. An exemption will not be granted if any registrant of
the active ingredient elects to conduct the testing. Any registrant receiving a low
volume minor use waiver must remain within the sales figures in their forecast
supporting the waiver request in order to remain qualified for such waiver. If granted a
waiver, a registrant will be required, as a condition of the waiver, to submit annual
sales reports. The Agency will respond to requests for waivers in writing.
To apply for a low volume, minor use waiver, you must submit the following
information, as applicable to your product(s), as part of your 90-day response to this
Notice:
(i). Total company sales (pounds and dollars) of all registered product(s)
containing the active ingredient. If applicable to the active ingredient, include foreign
sales for those products that are not registered in this country but are applied to sugar
(cane or beet), coffee, bananas, cocoa, and other such crops. Present the above
information by year for each of the past five years.
(ii) Provide an estimate of the sales (pounds and dollars) of the active
ingredient for each major use site. Present the above information by year for each of
the past five years.
(iii) Total direct production cost of product (s) containing the active ingredient
by year for the past five years. Include information on raw material cost, direct labor
cost, advertising, sales and marketing, and any other significant costs listed separately.
(iv) Total indirect production cost (e.g. plant overhead, amortized plant and
equipment) charged to product (s) containing the active ingredient by year for the past
five years. Exclude all non-recurring costs that were directly related to the active
ingredient, such as costs of initial registration and any data development.
(v) A list of each data requirement for which you seek a waiver. Indicate the
type of waiver sought and the estimated cost to you (listed separately for each data
requirement and associated test) of conducting the testing needed to fulfill each of these
data requirements.
(vi) A list of each data requirement for which you are not seeking any waiver
and the estimated cost to you (listed separately for each data requirement and associated
test) of conducting the testing needed to fulfill each of these data requirements.
(vii) For each of the next ten years, a year-by-year forecast of company sales
(pounds and dollars) of the active ingredient, direct production costs of product (s)
containing the active ingredient (following the parameters in item 2 above), indirect
production costs of product(s) containing the active ingredient (following the
parameters in item 3 above), and costs of data development pertaining to the active
ingredient.
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(viii) A description of the importance and unique benefits of the active
ingredient to users. Discuss the use patterns and the effectiveness of the active
ingredient relative to registered alternative chemicals and non-chemical control
strategies. Focus on benefits unique to the active ingredient, providing information that
is as quantitative as possible. If you do not have quantitative data upon which to base
your estimates, then present the reasoning used to derive your estimates. To assist the
Agency in determining the degree of importance of the active ingredient in terms of its
benefits, you should provide information on any of the following factors, as applicable
to your product(s): (a) documentation of the usefulness of the active ingredient in
Integrated Pest Management, (b) description of the beneficial impacts on the
environment of use of the active ingredient, as opposed to its registered alternatives,
(c) information on the breakdown of the active ingredient after use and on its
persistence in the environment, and (d) description of its usefulness against a pest(s) of
public health significance.
Failure to submit sufficient information for the Agency to make a determination
regarding a request for a low volume/minor use waiver will result in denial of the
request for a waiver.
b. Request for Waiver of Data
Option 9, under Item 9, on the Requirements Status and Registrant's Response
Form. This option may be used if you believe that a particular data requirement should
not apply because the requirement is inappropriate. You must submit a rationale
explaining why you believe the data requirements should not apply. You also must
submit the current label(s) of your product(s) and, if a current copy of your
Confidential Statement of Formula is not already on file you must submit a current
copy.
You will be informed of the Agency's decision in writing. If the Agency
determines that the data requirements of this Notice are not appropriate to your
product(s), you will not be required to supply the data pursuant to section 3(c)(2)(B). If
EPA determines that the data are required for your product(s) you must choose a ~~
method of meeting the requirements of this Notice within the time frame provided by
this Notice. Within 30 days of your receipt of the Agency's written decision, you must
submit a revised Requirements Status and Registrant s Response Form indicating the
option chosen.
2. Product Specific Data
If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete justification for the request including
technical reasons, data and references to relevant EPA regulations, guidelines or
policies. (Note: any supplemental data must be submitted in the format required by PR
Notice 86-5). This will be the only opportunity to state the reasons or provide
information in support of your request. If the Agency approves your waiver request,
you will not be required to supply the data pursuant to section 3(c)(2)(B) of FIFRA. If
the Agency denies your waiver request, you must choose an option for meeting the data
requirements of this Notice within 30 days of the receipt of the Agency's decision.
You must indicate and submit the option chosen on the product specific Requirements
Status and Registrant's Response Form. Product specific data requirements tor product
chemistry, acute toxicity and efficacy (where appropriate) are required for all products
and the Agency would grant a waiver only under extraordinary circumstances. You
should also be aware that submitting a waiver request will not automatically extend the
due date for the study in question. Waiver requests submitted~without adequate
supporting rationale will be denied and the original due date will remain in force.
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SECTION IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS
JNUTHJK
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice due
to failure by a registrant to comply with the requirements of this Data Call-in Notice, pursuant
to FIFRA section 3 (c) (2) (B). Events which may be the basis for issuance of a Notice of Intent
to Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of
this Notice.
2. Failure to submit on the required schedule an acceptable proposed or final
protocol when such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on a
study as required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this
Notice.
5. Failure to take a required action or submit adequate information pertaining to
any option chosen to address the data requirements (e.g., any required action or
information pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task
Forces, failure to comply with the terms of an agreement or arbitration
concerning joint data development or failure to comply with any terms of a data
waiver).
6. Failure to submit supportable certifications as to the conditions of submitted
studies, as required by Section III-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost
of developing data and provided proof of the registrant's receipt of such offer
or failure of a registrant on whom you rely for a generic data exemption either
to:
i. Inform EPA of intent to develop and submit the data required by this Notice
on a Data Call-In Response Form and a Requirements Status and Reqistrant's
Response Form.
ii. Fulfill the commitment to develop and submit the data as required by this
Notice; or
iii. Otherwise take appropriate steps to meet the requirements stated in this
Notice,
unless you commit to submit and do submit the required data in the specified
time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at any
time following the issuance of this Notice.
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IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds
for suspension include, but are not limited to, failure to meet any of the following:
1) EPA requirements specified in the Data Call-In Notice or other documents
incorporated by reference (including, as applicable, EPA Pesticide Assessment
Guidelines, Data Reporting Guidelines, and GeneTox Health Effects Test Guidelines)
regarding the design, conduct, and reporting of required studies. Such requirements
include, but are not limited to, those relating to test material, test procedures, selection
of species, number of animals, sex and distribution of animals, dose and effect levels to
be tested or attained, duration of test, and, as applicable, Good Laboratory Practices.
2) EPA requirements regarding the submission of protocols, including the
incorporation of any changes required by the Agency following review.
3) EPA requirements regarding the reporting of data, including the manner of
reporting, the completeness of results, and the adequacy of any required supporting (or
raw) data, including, but not limited to, requirements referenced or included in this
Notice or contained in PR 86-5. All studies must be submitted in the form of a final
report; a preliminary report will not be considered to fulfill the submission
requirement.
IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing
stocks of a pesticide product which has been suspended or cancelled if doing so would be
consistent with the purposes of the Act.
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3 (c) (2) (B) data request is outstanding generally would
not be consistent with the Act's purposes. Accordingly, the Agency anticipates granting
registrants permission to sell, distribute, or use existing stocks of suspended product(s) only in
exceptional circumstances. If you believe such disposition of existing stocks of your product (s)
which may be suspended for failure to comply with this Notice should be permitted, you have
the burden of clearly demonstrating to EPA that granting such permission would be consistent
with the Act. You also must explain why an "existing stocks" provision is necessary, including
a statement of the quantity of existing stocks and your estimate of the time required for their
sale, distribution, and use. Unless you meet this burden, the Agency will not consider any
request pertaining to the continued sale, distribution, or use of your existing stocks after
suspension.
If you request a voluntary cancellation of your product(s) as a response to this Notice
and your product is in full compliance with all Agency requirements, you will have, under
most circumstances, one year from the date your 90 day response to this Notice is due, to sell,
distribute, or use existing stocks. Normally, the Agency will allow persons other than the
registrant such as independent distributors, retailers and end users to sell, distribute or use
such existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of
voluntarily cancelled products containing an active ingredient for which the Agency has
particular risk concerns will be determined on a case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required
by this Notice will not result in the agency granting any additional time to sell, distribute, or
use existing stocks beyond a year from the date the 90 day response was due, unless you
demonstrate to the Agency that you are in full compliance with all Agency requirements,
including the requirements of this Notice. For example, if you decide to voluntarily cancel
your registration six months before a 3-year study is scheduled to be submitted, all progress
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reports and other information necessary to establish that you have been conducting the study in
an acceptable and good faith manner must have been submitted to the Agency, before EPA
will consider granting an existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
LJJMREASONABLE ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6 (a) (2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information
to the Agency. Registrants must notify the Agency of any factual information they have, from
whatever source, including but not limited to interim or preliminary results of studies,
regarding unreasonable adverse effects on man or the environment. This requirement
continues as long as the products are registered by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by
this Notice, call the contact person(sj listed in Attachment 1, the Data Call-in Chemical Status
Sheet.
All responses to this Notice must include completed Data Call-in Response Forms
(Attachment 2|and completed Requirements Status and Registrant's Response Forms
(Attachment 3), for both (generic and product specific data) and any other documents required
by this Notice, and should be submitted to the contact person(s) identified in Attachment 1. If
the voluntary cancellation or generic data exemption option is chosen, only the Generic and
Product Specific Data Call-in Response Forms need be submitted.
The Office of Compliance (OC) of the Office of Enforcement and Compliance
Assurance (OECA), EPA, will be monitoring the data being generated in response to this
Notice.
Sincerely yours,
Louis P. True, Jr., Acting Director
Special Review and
Reregistration Division
Attachments
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2 - Generic Data Caii-ln and Product Specific Data Call-In Response Forms with
Instructions
3 - Generic Data Call-in and Product Specific Data Call-In Requirements Status
and Registrant's Response Forms with Instructions
4 - EPA Grouping of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - EPA Acceptance Criteria
6 - List of Registrants Receiving This Notice
7 - Confidential Statement of Formula, Cost Share and Data Compensation Forms
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Attachment 1. Chemical Status Sheets
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Limonene DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Call-In Notice because you have product(s)
containing Limonene.
This Generic Data Call-In Chemical Status Sheet, contains an overview of data
required by this notice, and point or contact tor inquiries pertaining to the reregistration of
Limonene. This attachment is to be used in conjunction with (1) the Generic Data Call-In
Notice, (2) the Generic Data Call-In Response Form (Attachment 2), (3) the Requirements
Status and Registrant's Form (Attachment 2), (4) a list of registrants receiving this DCI
(Attachment 4), (5) the EPA Acceptance Criteria (Attachment 5), and (6) the Cost Share and
Data Compensation Forms in replying to this Limonene Generic Data Callln (Attachment F).
Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the generic database for
Limonene are contained in the Requirements Status and Registrant's Response, Attachment C.
The Agency has concluded that additional product chemistry data on Limonene are needed.
These data are needed to fully complete the reregistration of all eligible Limonene 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 Emily H. Mitchell at (703) 308-8583\
All responses to this Notice for the generic data requirements should be submitted to:
Emily H. Mitchell, Chemical Review Manager
Planning and Reregistration
Special Review and Registration Division (H7508W)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Limonene
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LIMONENE DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have
product(s) containing Limonene.
This Product Specific Data Call-In Chemical Status Sheet contains an overview of data
required by this notice, and point of contact tor inquiries pertaining to the reregistration of
Limonene. This attachment is to be used in conjunction with (1) the Product Specific Data
Call-In Notice, (2) the Product Specific Data Call-In Response Form (Attachment 2), (3) the
Requirements Status and Registrant's Form (Attachment 3), (4) EPA's Grouping of End-Use
Products for Meeting Acute Toxicology Data Requirement (Attachment 4), (5) the EPA
Acceptance Criteria (Attachment 5), (o) a list of registrants receiving this DCI (Attachment 6)
and (7) the Cost Share and Data Compensation Forms in replying to this Limonene Product
Specific Data Call-In (Attachment 7). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for Limonene are
contained in the Requirements Status and Registrant's Response, Attachment 3. The Agency
has concluded that additional data on Limonene are needed tor specific products. These data
are required to be submitted to the Agency within the time frame listed. These data are
needed to fully complete the reregistration of all eligible Limonene products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of Limonene, please contact
Emily H. Mitchell at (703) 308-8583.
If you have any questions regarding the product specific data requirements and
procedures established by this Notice, please contact Franklin Gee at (703) 308-8008.
(703) 308-8583.
All responses to this Notice for the Product Specific data requirements should be
submitted to:
Emily H. Mitchell
Chemical Review Manager Team 81
Product Reregistration Branch
Special Review and Reregistration Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Limonene
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Attachment 2. Combined Generic and Product Specific
Data Call-In Response Forms (Form A inserts) Plus
Instructions
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Instructions For Completing The "Data Call-In Response Forms" For The Generic And
Product Specific Data Call-In
INTRODUCTION
These instructions apply to the Generic and Product Specific "Data Call-In Response
Forms" and are to be used by registrants to respond to generic and product specific Data
Call-Ins as part of EPA's Reregistration Program under the Federal Insecticide, Fungicide,
and Rodenticide Act. The type of data call-in (generic or product specific) is indicated in
item number 3 ("Date and Type of DCI") on each form. BOTH "Data Call-In Response"
forms must be completed.
Although the form is the same for both generic and product specific data, instructions
for completing these forms are different. Please read these instructions carefully before filling
out the forms.
EPA has developed these forms individually for each registrant, and has preprinted
these forms with a number of items. DO NOT use these forms for any other active
ingredient.
Items 1 through 4 have been preprinted on the form. Items 5 through 7 must be
completed by the registrant as appropriate. Items 8 through 11 must be completed by the
registrant before submitting a response to the Agency.
The public reporting burden for this collection of information is estimated to average
15 minutes per response, including time for reviewing instructions, searching existing data
sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information. Send comments regarding the burden estimate or any other aspect of
this collection of information, including suggestions for reducing this burden, to Chief,
Information Policy Branch, Mail Code 213o, U.S. Environmental Protection Agency, 401 M
St., S.W., Washington, D.C. 20460; and to the Office of Management and Budget,
Paperwork Reduction Project 2070-0107, Washington, D.C. 20503.
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-in
Item l.ON BOTH FORMS: This item identifies your company name, number and
address.
Item 2.ON BOTH FORMS: This item identifies the case number, case name, EPA
chemical number and chemical name.
Item 3.ON BOTH FORMS: This item identifies the type of Data Call-in. The date
of issuance is date stamped.
Item 4.ON BOTH FORMS: This item identifies the EPA product registrations
relevant to the data call-in. Please note that you are also responsible for informing the Agency
of your response regarding any product that you believe may be covered by this Data Call-in
but that is not listed by the Agency in Item 4. You must bring any such apparent omission to
the Agency's attention within the period required for submission of this response form.
Item 5.ON BOTH FORMS: Check this item for each product registration you wish to
cancel voluntarily. If a registration number is listed for a product for which you previously
requested voluntary cancellation, indicate in Item 5 the date of that request. Since this Data
Call-in requires both generic and product specific data, you must complete item 5 on both
Data Call-In response forms. You do not need to complete any item on the Requirements
Status and Registrant's Response Forms.
Item 6a.ON THE GENERIC DATA FORM: Check this Item if the Data Call-in is
for generic data as indicated in Item 3 and you are eligible for a Generic Data Exemption for
the chemical listed in Item 2 and used in the subject product. By electing this exemption, you
agree to the terms and conditions of a Generic Data Exemption as explained in the Data
Call-In Notice.
If you are eligible for or claim a Generic Data Exemption, enter the EPA registration
Number of each registered source of that active ingredient that you use in your product.
Typically, if you purchase an EPA-registered product from one or more other
producers (who, with respect to the incorporated product, are in compliance with this and any
other outstanding Data Call-In Notice), and incorporate that product into all your products,
you may complete this item for all products listed on this form. If, however, you produce the
active ingredient yourself, or use any unregistered product (regardless of the fact that some of
your sources are registered), you may not claim a Generic Data Exemption and you may not
select this item.
Item 6b.ON THE GENERIC DATA FORM: Check this Item if the Data Call-in is
for generic data as indicated in Item 3 and if you are agreeing to satisfy the generic data
requirements of this Data Call-In. Attach the Requirements Status and Registrant's Response
Form that indicates how you will satisfy those requirements.
NOTE: Item 6a and 6b are not applicable for Product Specific Data.
Item 7a.ON THE PRODUCT SPECIFIC DATA FORM: For each manufacturing
use product (MUP) for which you wish to maintain registration, you must agree to satisfy the
data requirements by responding "yes."
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Item Tb.For each end use product (EUP) for which you wish to maintain registration,
you must agree to satisfy the data requirements by responding "yes."
FOR BOTH MUP and EUP products
You should also respond "yes" to this item (7a for MUP's and 7b for EUP's) if your
product is identical to another product and you qualify for a data exemption. You must
provide the EPA registration numbers of your source (s); do not complete the Requirements
Status and Registrant's Response form. Examples of such products include repackaged
products and Special Local Needs (Section 24cj products which are identical to federally
registered products.
If you are requesting a data waiver, answer "yes" here; in addition, on the
"Requirements Status and Registrant's Response" form under Item 9, you must respond with
option 7 (Waiver Request) for each study for which you are requesting a waiver.
NOTE: Item 7 a and 7b are not applicable for Generic Data.
Item 8.ON BOTH FORMS: This certification statement must be signed by an
authorized representative of your company and the person signing must include his/her title.
Additional pages used in your response must be initialled and dated in the space provided for
the certification.
Item 9.ON BOTH FORMS: Enter the date of signature.
Item 10.ON BOTH FORMS: Enter the name of the person EPA should contact with
questions regarding your response.
Item 11.ON BOTH FORMS: Enter the phone number of your company contact.
Note: You may provide additional information that does not fit on this form in a signed letter that accompanies your response. For example, you may wish to
report that your product has already been transferred to another company or that you have already voluntarily cancelled this product. For these cases,
please supply all relevant details so that EPA can ensure that its records are correct.
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Attachment 3. Generic and Product Specific Requirement
Status and Registrant's Response Forms (Form B inserts)
and Instructions
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Instructions For Completing The "Data Call-in Response Forms" For The Generic And
Product Specific Data Call-In
INTRODUCTION
These instructions apply to the Generic and Product Specific "Data Call-In Response
Forms" and are to be used by registrants to respond to generic and product specific Data Call-Ins
as part of EPA's Reregistration Program under the Federal Insecticide, Fungicide, and
Rodenticide Act. The type of data call-in (generic or product specific) is indicated in item
number 3 ("Date and Type of DCI") on each form. BOTH "Data Call-In Response" forms
must be completed.
Although the form is the same for both generic and product specific data, instructions for
completing these forms are different. Please read these instructions carefully before filling out
the forms.
EPA has developed these forms individually for each registrant, and has preprinted these
forms with a number of items. DO NOT use these forms for any other active ingredient.
Items 1 through 4 have been preprinted on the form. Items 5 through 7 must be completed
by the registrant as appropriate. Items 8 through 11 must be completed by the registrant before
submitting a response to the Agency.
The public reporting burden for this collection of information is estimated to average 15
minutes per response, including time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing the collection of
information. Send comments regarding the burden estimate or any other aspect of this collection
of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, Mail Code 2136, U.S. Environmental Protection Agency, 401 M St., S.W., Washington,
D.C. 20460; and to the Office of Management and Budget, Paperwork Reduction Project
2070-0107, Washington, D.C. 20503.
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-in
Item l.ON BOTH FORMS: This item identifies your company name, number and
address.
Item 2.ON BOTH FORMS: This item identifies the case number, case name, EPA
chemical number and chemical name.
Item 3.ON BOTH FORMS: This item identifies the type of Data Call-in. The date of
issuance is date stamped.
Item 4.ON BOTH FORMS: This item identifies the EPA product registrations relevant
to the data call-in. Please note that you are also responsible for informing the Agency of your
response regarding any product that you believe may be covered by this Data Call-in but that is
not listed by the Agency in Item 4. You must bring any such apparent omission to the Agency's
attention within the period required for submission of this response form.
Item 5.ON BOTH FORMS: Check this item for each product registration you wish to
cancel voluntarily. If a registration number is listed for a product for which you previously
requested voluntary cancellation, indicate in Item 5 the date of that request. Since this Data Call-
in requires both generic and product specific data, you must complete item 5 on both Data Call-In
response forms. You do not need to complete any item on the Requirements Status and
Registrant's Response Forms.
Item 6a.ON THE GENERIC DATA FORM: Check this Item if the Data Call-in is for
generic data as indicated in Item 3 and you are eligible for a Generic Data Exemption for the
chemical listed in Item 2 and used in the subject product. By electing this exemption, you agree
to the terms and conditions of a Generic Data Exemption as explained in the Data Call-in Notice.
If you are eligible for or claim a Generic Data Exemption, enter the EPA registration
Number of each registered source of that active ingredient that you use in your product.
j, 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.ON THE GENERIC DATA FORM: Check this Item if the Data Call-in is for
generic data as indicated in Item 3 and if you are agreeing to satisfy the generic data requirements
of this Data Call-In. Attach the Requirements Status and Registrant's Response Form that
indicates how you will satisfy those requirements.
NOTE: Item 6a and 6b are not applicable for Product Specific Data.
Item 7a.ON THE PRODUCT SPECIFIC DATA FORM: For each manufacturing use
product (MUP) for which you wish to maintain registration, you must agree to satisfy the data
requirements by responding "yes."
Item Tb.For each end use product (EUP) for which you wish to maintain registration, you
must agree to satisfy the data requirements by responding "yes."
148
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FOR BOTH MUP and EUP products
You should also respond "yes" to this item (7a for MUP's and 7b for EUP's) if your
product is identical to another product and you qualify for a data exemption. You must provide
the EPA registration numbers of your source (s); do not complete the Requirements Status and
Registrant's Response form. Examples of such products include repackaged products and Special
Local Needs (Section 24c) products which are identical to federally registered products.
If you are requesting a data waiver, answer "yes" here; in addition, on the "Requirements
Status and Registrant's Response" form under Item 9, you must respond with option/ (Waiver
Request) for each study for which you are requesting a waiver.
NOTE: Item 7 a and 7b are not applicable for Generic Data.
Item 8.ON BOTH FORMS: This certification statement must be signed by an authorized
representative of your company and the person signing must include his/her title. Additional
pages used in your response must be initialled and dated in the space provided for the
certification.
Item 9.ON BOTH FORMS: Enter the date of signature.
Item 10.ON BOTH FORMS: Enter the name of the person EPA should contact with
questions regarding your response.
Item 11.ON BOTH FORMS: Enter the phone number of your company contact.
Note: You may provide additional information that does not fit on this form in a signed letter that accompanies your response. For example, you may wish to
report that your product has already been transferred to another company or that you have already voluntarily cancelled this product. For these cases,
please supply all relevant details so that EPA can ensure that its records are correct.
149
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150
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Attachment 4. EPA Batching of End-Use Products for
Meeting Data Requirements for Reregistration
151
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152
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EPA'S BATCHING OF PRODUCTS CONTAINING D-LIMONENE AS THE ACTIVE
INGREDIENT FOR MEETING ACUTE TOXICITY DATA REQUIREMENTS FOR
REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the acute toxicity
data requirements for reregistration of products containing the active ingredient d-limonene (1-
Methyl-4-(l-methylethenyl) cyclohexene) the Agency has batched products which can be considered
similar in terms of acute toxicity. Factors considered in the sorting process include each product's
active and inert ingredients (identity, percent composition and biological activity), type of formulation
(e.g., emulsifiable concentrate, aerosol, wettable powder, granular, etc.), and labeling (e.g., signal
word, use classification, precautionary labeling, etc.). Note that the Agency is not describing batched
products as "substantially similar" since some products within a batch may not be considered
chemically similar or have identical use patterns.
Using available information, batching has been accomplished by the process described in the
preceding paragraph. Notwithstanding the batching process, the Agency reserves the right to require,
at any time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or cite a
single battery of six acute lexicological studies to represent all the products within that batch. It is
the registrants' option to participate in the process with all other registrants, only some of the other
registrants, or only their own products within a batch, or to generate all the required acute
lexicological studies for each of their own products. If a registrant chooses to generate the data for
a batch, he/she must use one of the products within the batch as the test material. If a registrant
chooses to rely upon previously submitted acute toxicity data, he/she may do so provided that the
data base is complete and valid by today's standards (see acceptance criteria attached), the
formulation tested is considered by EPA to be similar for acute toxicity, and the formulation has not
been significantly altered since submission and acceptance of the acute toxicity data. Regardless of
whether new data is generated or existing data is referenced, registrants must clearly identify the test
material by EPA Registration Number. If more than one confidential statement of formula (CSF)
exists for a product, the registrant must indicate the formulation actually tested by identifying the
corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow the
directions given in the Data Call-in Notice and its attachments appended to the RED. The DCI Notice
contains two response forms which are to be completed and submitted to the Agency within 90 days
of receipt. The first form, "Data Call-In Response," asks whether the registrant will meet the data
requirements for each product. The second form, "Requirements Status and Registrant's Response,"
lists the product specific data required for each product, including the standard six acute toxicity tests.
A registrant who wishes to participate in a batch must decide whether he/she will provide the data
or depend on someone else to do so. If a registrant supplies the data to support a batch of products,
he/she must select one of the following options: Developing Data (Option 1), Submitting an Existing
Study (Option 4), Upgrading an Existing Study (Option 5) or Citing an Existing Study (Option 6).
If a registrant depends on another's data, he/she must choose among: Cost Sharing (Option 2), Offers
to Cost Share (Option 3) or Citing an Existing Study (Option 6). If a registrant does not want to
participate in a batch, the choices are Options 1, 4, 5 or 6. However, a registrant should know that
choosing not to participate in a batch does not preclude other registrants in the batch from citing
his/her studies and offering to cost share (Option 3) those studies.
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Table 1 displays the batch for the active ingredient d-limonene.
Table 1
Batch
1
Registration Number
4758-153
11715-243
% Active Ingredients
d-limonene ... 0.920%
linalool ... 0.925%
piperonyl butoxide ... 0.500%
propylene glycol ... 10.000%
d-limonene ... 0.920%
linalool ... 0.925%
piperonyl butoxide ... 0.500%
propylene glycol ... 10.000%
Form
non-aerosol
spray
non-aerosol
spray
Table 2 lists those products the Agency was unable to batch. These products were either considered
not to be similar to other products for purposes of acute toxicity or the Agency lacked sufficient
information for decision making. Registrants of these products are responsible for meeting the acute
toxicity data requirements for each product.
Table 2
Unbatched Products
Reg. No.
4758-141
4758-142
4758-143
4758-144
4758-145
% Active Ingredient
d-limonene
d-limonene
d-limonene
pyrethrins
piperonyl butoxide
d-limonene
d-limonene
... 5.00
... 32.00
... 9.20
... 0.05
... 0.25
... 78.20
... 5.00
Form
liquid
liquid
liquid
liquid
liquid
Table 2 (continued)
4758-146
4758-149
45987-1
45987-2
45987-5
62012-1
d-limonene
d-limonene
d-limonene
dihydro-5-pentyl-2(3H) furanone
dihydro-5-heptyl-2(3H) furanone
d-limonene
dihydro-5-pentyl-2(3H) furanone
dihydro-5-heptyl-2(3H) furanone
d-limonene
dihydro-5-pentyl-2(3H) furanone
dihydro-5-heptyl-2(3H) furanone
d-limonene
... 5.00
... 92.00
.. 4.015
.. 0.024
.. 0.049
.. 4.015
.. 0.024
.. 0.049
.. 4.015
.. 0.024
.. 0.049
... 5.00
aerosol
liquid
granular
liquid
vinyl sheet
liquid
154
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Attachment 5. EPA Acceptance Criteria
155
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156
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SUBDIVISION D
Guideline Study Title
Series 61 Product Identity and Composition
Series 62 Analysis and Certification of Product Ingredients
Series 63 Physical and Chemical Characteristics
157
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61 Product Identity and Composition
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Name of technical material tested (include product name and trade name, if appropriate).
2. Name, nominal concentration, and certified limits (upper and lower) for each active ingredient and each intentionally-
added inert ingredient.
3. Name and upper certified limit for each impurity or each group of impurities present at > 0.1% by weight and for
certain lexicologically significant impurities (e.g., dioxins, nitrosamines) present at < 0.1%.
4. Purpose of each active ingredient and each intentionally-added inert.
5. Chemical name from Chemical Abstracts index of Nomenclature and Chemical Abstracts Service (CAS) Registry
Number for each active ingredient and, if available, for each intentionally-added inert.
6. Molecular, structural, and empirical formulas, molecular weight or weight range, and any company assigned
experimental or internal code numbers for each active ingredient.
7. Description of each beginning material in the manufacturing process.
EPA Registration Number if registered;
for other beginning materials, the following:
Name and address of manufacturer or supplier.
Brand name, trade name or commercial designation.
Technical specifications or data sheets by which manufacturer or supplier describes composition, properties or
toxicity.
8. Description of manufacturing process.
Statement of whether batch or continuous process.
Relative amounts of beginning materials and order in which they are added.
Description of equipment.
Description of physical conditions (temperature, pressure, humidity) controlled in each step and the parameters
that are maintained.
Statement of whether process involves intended chemical reactions.
Flow chart with chemical equations for each intended chemical reaction.
Duration of each step of process.
Description of purification procedures.
Description of measures taken to assure quality of final product.
9. Discussion of formation of impurities based on established chemical theory addressing (1) each impurity which may
be present at _>_ 0.1% or was found at _>_ 0.1% by product analyses and (2) certain lexicologically significant impurities
(see #3).
158
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62 Analysis and Certification of Product Ingredients
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered. Use a table to present the information
in items 6, T, and 8.
Does your study meet the following acceptance criteria?
1. Five or more representative samples (batches in case of batch process) analyzed for each active ingredient and all
impurities present at > 0.1%.
2. Degree of accountability or closure > ca 98%.
3. Analyses conducted for certain trace tdxTcTmpurities at lower than 0.1% (examples, nitrosamines in the case of products
containing dinitroanilines or containing secondary or tertiary amines/alkanolamines plus nitrites; polyhalogenated
dibenzodioxins and dibenzofurans). [Note that in the case of nitrosamines both fresh and stored samples must be
analyzed.].
4. Complete and detailed description of each step in analytical method used to analyze above samples.
5. Statement of precision and accuracy of analytical method used to analyze above samples.
6. Identities and quantities (including mean and standard deviation) provided for each analyzed ingredient.
7. Upper and lower certified limits proposed for each active ingredient and intentionally added inert along with explanation
of now the limits were determined.
8. Upper certified limit proposed for each impurity present at > 0.1% and for certain lexicologically significant impurities
at < 0.1% along with explanation of how limit determine!!.
9. Analytical methods to verify certified limits of each active ingredient and impurities (latter not required if exempt from
requirement of tolerance or if generally recognized as safe by FDA) are fully described.
10. Analytical methods (as discussed in #9) to verify certified limits validated as to their precision and accuracy.
159
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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 MeltingPoint
Reported in °C
Any observed decomposition reported
63-6 Boiling Point
Reported in °C
Pressure under which B.P. measured reported
Any observed decomposition reported
63-7 Density, Bulk Density, Specific Gravity
Measured at about 20-25° C
Density of technical grade active ingredient reported in g/ml or the specific gravity of liquids reported with reference
to water at 20° C. [Note: Bulk density of registered products~~may be reported in lbs/ft3 or Ibs/gallon.]
63-8 Solubility
Determined in distilled water and representative polar and non-polar solvents, including those used in formulations and
analytical methods for the pesticide
Measured at about 20-25° C
Reported in g/100 ml (other units like ppm acceptable if sparingly soluble)
63-9 Vapor Pressure
Measured at 25° C (or calculated by extrapolation from measurements made at higher temperature if pressure too low
to measure at 25° C)
Experimental procedure described
Reported in mm Hg (torr) or other conventional units
63-10 Dissociation Constant
Experimental method described
Temperature of measurement specified (preferably about
20-2B°C)
63-11 Octanol/water Partition Coefficient
Measured at about 20-25° C
Experimentally determined and description of procedure provided (preferred method-45 Fed. Register 77350)
Data supporting reported value provided
63-12 pH
Measured at about 20-25° C
Measured following dilution or dispersion in distilled water
63-13 Stability
Sensitivity to metal ions and metal determined
Stability at normal and elevated temperatures
Sensitivity to sunlight determined
160
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SUBDIVISION F
Guideline Study Title
81-1 Acute Oral Toxicity in the Rat
81-2 Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
81-3 Acute Inhalation Toxicity in the Rat
81-4 Primary Eye Irritation in the Rabbit
81-5 Primary Dermal Irritation Study
81-6 Dermal Sensitization in the Guinea Pig
161
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81-1 Acute Oral Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. At least 5 young adult rats/sex/group.
3.^ Dosing, single oral may be administered over 24 hrs.
4.*! Vehicle control if other than water.
5. Doses tested, sufficient to determine a toxicity category or a limit dose (5000 mg/kg).
6. Individual observations at least once a day.
7. Observation period to last at least 14 days, or until all test animals appear normal whichever is longer.
8. Individual daily observations.
9. Individual body weights.
10. Gross necropsy on all animals.
Criteria marked with an * are supplementaLand may not be required for every study.
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81-2 Acute Dermal toxicity in the Rat, Rabbit or Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. At least 5 animals/sex/group.
3.^ Rats 200-300 gm, rabbits 2.0-3.0 kg or guinea pigs 350-450 gm.
4. Dosing, single dermal.
5. Dosing duration at least 24 hours.
6.^ Vehicle control, only if toxicity of vehicle is unknown.
7.1 Doses tested, sufficient to determine a toxicity category or a limit dose (2000 mg/kg).
8. Application site clipped or shaved at least 24 hours oefore dosing.
9. Application site at least 10% of body surface area.
10. Application site covered with a porous nonirritating cover to retain test material and to prevent
ingestion.
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
Criteria marked with an * are supplemental^and may not be required for every study.
163
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81-3 Acute Inhalation Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Product is a gas, a solid which may produce a significant vapor hazard based on toxicity and expected use or contains
particles of inhalable size for man (aerodynamic diameter 15 pm or less).
3. At least 5 young adult rats/sex/group.
4. Dosing, at least 4 hours by inhalation.
5. Chamber air flow dynamic, at least 10 air changes/hour, at least 19% oxygen content.
6. Chamber temperature, 22° C (+_2°), relative humidity 40-60%.
7. Monitor rate of air flow.
8. Monitor actual concentrations of test material in breathing zone.
9. Monitor aerodynamic particle size for aerosols.
10. Doses tested, sufficient to determine a toxicity category or a limit dose (5 mg/L actual concentration of respirable
substance).
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
164
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81-4 Primary Eye Irritation in the Rabbit
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive, causes severe
dermal irritation or has a pH of < 2 or > 11.5.
3. 6 adult rabbits.
4. Dosing, instillation into the conjunctival sac of one eye
per animal.
5. Dose, 0.1 ml if a liquid; 0.1 ml or not more than 100 mg if a solid, paste or particulate substance.
6. Solid or granular test material ground to a fine dust.
7. Eyes not washed for at least 24nours.
8. Eyes examined and graded for irritation before dosing and
at 1, 24, 48 and 72 hr, then daily until eyes are normal
or 21 days (whichever is shorter).
9.^ Individual daily observations.
Criteria marked with an * are supplementaland may not be required for every study.
165
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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 <7. or > 11.5.
3. 6 adult animals.
4. Dosing, single dermal.
5. Dosing duration 4 hours.
6. Application site shaved or clipped at least 24 hours prior to dosing.
7. Application site approximately 6 cm2.
8. Application site covered with a gauze patch held in place with nonirritating tape.
9. Material removed, washed with water, without trauma to application site.
10. Application site examined and graded for irritation at 1, 24, 48 and 72 hr, then daily until normal or 14 days (whichever
is snorter).
11.^ Individual daily observations.
Criteria marked with an * are supplemental^nd may not be required for every study.
ibb
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81-6 Dermal Sensitization in the Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive or has a
pHof <2of >11.5.
3. une oflhe following methods is utilized:
Freund's complete adjuvant test
Guinea pig maximization test
Split adjuvant technique
Buehler test
Open epicutaneous test
Mauer optimization test
Footpad technique in guinea pig.
4. Complete description of test.
5.^ Reference for test.
6C Test followed essentially as described in reference document.
7. Positive control included (may provide historical data conducted within the last 6 months).
Criteria marked with an * are supplementajand may not be required for every study.
167
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168
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Attachment 6. List of All Registrants Sent This Data Call-In (insert) Notice
169
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170
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Attachment 7. Cost Share Data Compensation Forms, Confidential Statement of
Formula Form and Instructions
171
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172
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174
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Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed
copies of the form are required. Following are basic instructions:
a. All the blocks on the form must be filled in and answered completely.
b. If any block is not applicable, mark it N/A.
c. The CSF must be signed, dated and the telephone number of the responsible
party must be provided.
d. All applicable information which is on the product specific data submission
must also be reported on the CSF.
e. All weights reported under item 7 must be in pounds per gallon for liquids and
pounds per cubic feet for solids.
f. Flashpoint must be in degrees Fahrenheit and flame extension in inches.
g. For all active ingredients, the EPA Registration Numbers for the currently
registered source products must be reported under column 12.
h. The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and
all common names for the trade names must be reported.
i. For the active ingredients, the percent purity of the source products must be
reported under column 10 and must be exactly the same as on the source
product's label.
j. All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or
grams. In no case will volumes be accepted. Do not mix English and metric
system units (i.e., pounds and kilograms).
k. All the items under column 13.b. must total 100 percent.
1. All items under columns 14.a. and 14.b. for the active ingredients must
represent pure active form.
m. The upper and lower certified limits for ail active and inert ingredients must
follow the 40 CFR 158.175 instructions. An explanation must be provided if the
proposed limits are different than standard certified limits.
n. When new CSFs are submitted and approved, all previously submitted CSFs
become obsolete for that specific formulation.
175
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176
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r/EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OMB No. 2070-0106
2070-0057
Approval Expires 3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Please fill In blanks below.
Company Name
Product Name
Company Number
EPA Reg. No.
I Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data.
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
Name of Firm(s)
Date of Offer
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company's Authorized Representative
Date
Name and Title (Please Type or Print)
EPA Form 8570-32 (5/91) Replaces EPA Form 8580, which is obsolete
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&EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
OUt M«v. 2070-0101
2070-OOS7
Approval Explfw 3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection ol information, including suggestions for reducing this burden, to Chief, Information Policy
Branch. PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington. DC 20503.
Please fill In blanks below.
Company Nairn
Product HUM
Company Numb«r
EPA R*g. MO.
I Certify that:
1. For each study cited in support of registration or ^registration under the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the
written permission of the original data submitter to cite that study.
2. That for each study cited in support of registration or ^registration under FIFRA that is NOT an exclusive use
study, I am the original data submitter, or I have obtained the written permission of the original data submitter, or I
have notified in writing the company(ies) that submitted data I have cited and have offered to: (a) Pay
compensation for those data in accordance with sections 3(C)(1)(D) and 3(c)(2)(D) of FIFRA; and (b) Commence
negotiation to determine which data are subject to the compensation requirement of FIFRA and the amount of
compensation due. if any. The companies I have notified are: (check one)
[ ] The companies who have submitted the studies listed on the back of this loan or attached
sheets, or indicated on the attached "Requirements Status and Registrants' Response Form,*
3. That I have previously complied with section 3(c)(i )(D) of FIFRA for the studies I have tiled in support of
registration or ^registration under FIFRA.
Signature
Date
Nam* and Till* (Ploaao Typo or Print)
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the
registration or ^registration of my products, to the extent required by FIFRA sections 3(c)(i)(D) and 3(c)(2)(0).
Signature
Date
Name and TMIo (Ploaaa Typo or Print)
EPA Form 1570-31 (4-»0)
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APPENDIX G. FACT SHEET
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United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-94-030
September 1994
R.E.D. FACTS
Limonene
Pesticide
Reregistration
Use Profile
All pesticides sold or distributed in the United States must be
registered by EPA, based on scientific studies showing that they can be used
without posing unreasonable risks to people or the environment. Because of
advances in scientific knowledge, the law requires that pesticides which
were first registered years ago be reregistered to ensure that they meet
today's more stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency imposes
any regulatory controls that are needed to effectively manage each
pesticide's risks. EPA then reregisters pesticides that can be used without
posing unreasonable risks to human health or the environment.
When a pesticide is eligible for reregistration, EPA announces this and
explains why in a Reregistration Eligibility Decision (RED) document. This
fact sheet summarizes the information in the RED document for
reregistration case 3083, limonene.
Limonene is a naturally occurring chemical which is used in many
food products, soaps and perfumes for its lemon-like flavor and odor.
Limonene also is a registered active ingredient in 15 pesticide products used
as insecticides, insect repellents, and dog and cat repellents.
Pesticide products containing limonene are used for flea and tick
control on pets, as an insecticide spray, an outdoor dog and cat repellent, a
fly repellent tablecloth, a mosquito larvicide, and an insect repellent for use
on humans. Formulations include ready-to-use solutions, emulsifiable
concentrates, granulars and impregnated material. Limonene is applied by
hand as needed, both indoors and outdoors. Use practice limitations include
a label prohibition against use on weanling kittens and a caution against use
of undiluted product.
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Regulatory
History
Human Health
Assessment
Limonene was first registered as a insecticide in the U.S. in 1958. It
was registered as an antimicrobial in 1971, and as a dog and cat repellent in
1983. In May 1988, EPA announced that limonene is considered an inert
rather than an active ingredient when used in antimicrobial products (please
see 40 CFR 153.139(a)). In April 1994, limonene was granted an
exemption from the requirement of a tolerance (or maximum residue limit)
when it is an inert ingredient used as a solvent or fragrance in pesticide
formulations (please see 40 CFR 180.1001 (c), (e)). The Food and Drug
Administration (FDA) lists limonene as Generally Recognized as Safe
(GRAS) as a food additive or flavoring and a fragrance additive (please see
21 CFR 182.60). Currently, 15 limonene pesticide products are registered.
Limonene is among those pesticide active ingredients for which a
reduced set of generic data requirements is appropriate for registration or
reregistration. Limonene is naturally occurring, has been established as an
inert, is exempt from the requirement of a tolerance, and is recognized as
safe by FDA. Its effects are well known and documented in scientific
literature; additional testing would not likely provide any new findings.
Adequate information is available to characterize its risks to humans and
animals.
Toxicity
Limonene is of relatively low acute toxicity taken orally. It is a
dermal irritant when applied at high concentrations and may cause dermal
sensitization. A 90-day dermal toxicity study using the formulated product
is required as confirmatory data to support reregistration of the insect
repellent that is to be applied directly to human skin.
A subchronic study by the National Toxicology Program (NTP) using
rats and mice resulted in decreased body weights, kidney disease and
mortality at the highest dose tested. A chronic toxicity study by NTP using
rats resulted in decreased body weight, kidney disease and kidney tumors,
which occurred due to a species-specific mechanism. Limonene is not
considered a human carcinogen, a developmental toxicant or mutagenic.
Dietary Exposure
Limonene occurs naturally in citrus and other fruits, vegetables, meats
and spices. It also is used in a variety of foods and beverages (as well as in
soaps and perfumes) to add lemon-like flavor and aroma. FDA considers
limonene Generally Recognized as Safe (GRAS) as a food additive or
flavoring, and as a fragrance additive. EPA has granted limonene an
exemption from the requirement of a tolerance when it is used as an inert
ingredient in pesticide formulations, and when used as an insect repellent
tablecloth.
As a pesticide active ingredient, limonene is not registered for food or
feed crop uses and is not expected to result in dietary exposure.
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Environmental
Assessment
Occupational and Residential Exposure
People and pets may be exposed to limonene during and after
application in household settings. Human exposure may occur during
application of pet flea products, animal repellent granules or insecticide
sprays, or during use of insect repellent impregnated tablecloths.
Toxicologic concerns for humans from these exposures include skin
irritation and sensitization. Ocular irritation also may occur if limonene
products accidentally enter the eye and are not washed away.
Limonene is used in several shampoo, dip and spray products applied
dermally to domestic animals to control fleas and ticks. Adverse reactions
have been reported in a small percentage of animals, especially cats,
following exposure to limonene products. Kittens and young cats seem to
be most sensitive. Product labels bear precautionary statements warning of
the potential for dermal irritation, prohibiting use on weanling kittens, and
cautioning against use of undiluted product on pets.
Human Risk Assessment
Dietary exposure to limonene is not a concern. Limonene occurs
naturally in foods, is used as a flavoring agent, is generally recognized as
safe by FDA, and has only one food-related pesticide use (as an insect
repellent impregnating tablecloths) that EPA has exempted from tolerance
requirements.
People may be exposed to limonene when applying flea and tick
control shampoos, dips or sprays to their pets, when applying animal
repellent granules or insecticide sprays, or when using impregnated
tablecloths. Skin irritation and sensitization or eye irritation may occur
from these uses. In addition, adverse reactions may occur in some pets,
especially cats, treated with the flea and tick control products. Additional
precautionary statements are required on limonene product labeling to
reduce the potential for adverse effects among users and treated pets.
Environmental Fate
Limonene is insoluble and is expected to be stable in water.
Ecological Effects
Technical limonene is practically nontoxic to birds on a subacute
dietary basis, and is slightly toxic to freshwater fish and invertebrates on an
acute basis. The formulated product is practically nontoxic to birds on an
acute and subacute dietary basis. It is practically nontoxic to freshwater fish
and slightly toxic to freshwater invertebrates on an acute basis. Based on
acute toxicity data using rats, limonene is practically nontoxic to mammals.
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Additional Data
Required
Product Labeling
Changes Required
Ecological Effects Risk Assessment
Potential risk to birds might occur from ingesting limonene granules
spread on lawns, sidewalks or driveways, or from consuming insects
contaminated with limonene. However, based on the lack of toxicity of
limonene to birds, little risk is anticipated.
Similarly, mammals are not likely to ingest a sufficient quantity of
limonene granules to be at risk, particularly since limonene is practically
nontoxic to mammals.
The mosquito larvicide use of limonene produces an oily film that is
expected to dissipate rapidly, posing no major ecological concern for
freshwater invertebrates or other aquatic species. Minimal risks to aquatic
species, including endangered aquatic species, are expected from runoff into
pond water from applications of the granular product.
EPA is requiring a 90-day dermal toxicity study for the recently
registered limonene personal insect repellent product, to confirm its
regulatory assessments and conclusions. The Agency also is requiring
product-specific data including product chemistry and acute toxicity studies,
revised Confidential Statements of Formula (CSFs) and revised labeling for
reregistration.
All limonene end-use products must comply with EPA's current
pesticide product labeling requirements, and with the following:
Environmental Hazard Statements
End-use products with the mosquito larvicide use must bear the following
statement:
"Do not contaminate water when disposing of equipment washwater or
rinsate. Consult with your State Agency in charge of fish and game
before applying to public waters to determine if a permit is needed."
End-use products without the mosquito larvicide use must bear the following
statement:
"Do not apply directly to water, or to areas where surface water is
present or to intertidal areas below the mean high-water mark. Do not
contaminate water when disposing of equipment washwater or
rinsate."
Precautionary Statements
To reduce the risk of adverse effects which occasionally occur in pets
exposed to limonene flea and tick control products, and to reduce risks of
skin irritation/ sensitization to product users, the following strengthened
statements are required on labels of products intended for use on domestic
animals:
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Regulatory
Conclusion
For More
Information
Add: "Applicators of flea and tick dip (concentrates), spray or
shampoo products are to use protective gloves to reduce the risk of
dermal irritation or dermal sensitization."
Add: "Flea dip concentrates may harm animals when used at greater
strength than specified on the label."
Change the age for product use on kittens/puppies to several months
or a year.
Change the statement, "Use with care on nursing animals," to "Do not
use on nursing animals or any animal which is in poor health."
Provide a list of symptoms which may occur when animals are
sensitive to the product, to the precautionary statement, "Individual
animals may be more sensitive to the product."
The use of currently registered pesticide products containing limonene
in accordance with approved labeling will not pose unreasonable risks or
adverse effects to humans or the environment. Therefore, all uses of these
products are eligible for reregistration.
These limonene products will be reregistered once the required
confirmatory data, product-specific data, revised Confidential Statements of
Formula and revised labeling are received and accepted by EPA.
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for limonene during a 60-day time period, as
announced in a Notice of Availability published in the Federal Register. To
obtain a copy of the RED document or to submit written comments, please
contact the Pesticide Docket, Public Response and Program Resources
Branch, Field Operations Division (7506C), Office of Pesticide Programs
(OPP), US EPA, Washington, DC 20460, telephone 703-305-5805.
Following the comment period, the limonene RED document will be
available from the National Technical Information Service (NTIS), 5285
Port Royal Road, Springfield, VA 22161, telephone 703-487-4650.
For more information about EPA's pesticide reregistration program,
the limonene RED, or reregistration of individual products containing
limonene, please contact the Special Review and Reregistration Division
(7508W), OPP, US EPA, Washington, DC 20460, telephone 703-308-8000.
For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms, please contact
the National Pesticides Telecommunications Network (NPTN). Call toll-
free 1-800-858-7378, between 8:00 am and 6:00 pm Central Time, Monday
through Friday.
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