United States Office of Prevention, Pesticides EPA 738-R-95-018
Environmental Protection And Toxic Substances July 1995
Agency (7508W)
&EPA Reregistration
Eligibility Decision (RED)
Fenitrothion
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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 fenitrothion. The
enclosed Reregistration Eligibility Decision (RED) contains the Agency's evaluation of the
data base of this chemical, its conclusions of the potential human health and environmental
risks of the current product uses, and its decisions and conditions under which these uses and
products will be eligible for reregistration. The RED includes the data and labeling
requirements for products for reregistration. It may also include requirements for additional
data (generic) on the active ingredient(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
Moana Appleyard at (703) 308-8175. Address any questions on required generic data to the
Special Review and Reregistration Division representative Dennis McNeilly at 308-8066.
Sincerely yours,
Lois A. Rossi, 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
FENITROTHION
LIST A
CASE 0445
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
0445 REREGISTRATION ELIGIBILITY DECISION TEAM i
EXECUTIVE SUMMARY v
I. INTRODUCTION 1
II. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Estimated Usage of Pesticide 4
D. Data Requirements 4
E. Regulatory History 4
III. SCIENCE ASSESSMENT 6
A. Physical Chemistry Assessment 6
B. Human Health Assessment 6
1. Toxicology Assessment 6
a. Acute Toxicity 6
b. Subchronic Toxicity 7
c. Chronic Toxicity 8
d. Carcinogenicity 9
e. Developmental Toxicity 9
f. Reproductive Toxicity 10
g. Mutagenicity 10
h. Metabolism 11
i. Other Toxic Endpoints 11
j. Reference Dose 12
2. Exposure Assessment 13
a. Dietary Exposure 13
b. Occupational and Residential Exposure 14
(1) Use Summary 14
(2) Summary of Toxicity Concerns Impacting
Occupational Exposures 15
(3) Summary of Potential Occupational Exposures ... 16
(4) Handler (Mixers, Loaders, Applicators, Etc.)
Exposures 17
(5) Additional Occupational Exposure Studies 20
(6) Post Application Worker Exposures and Assumptions
20
3. Risk Assessment 22
a. Dietary 22
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b. Occupational and Residential 23
C. Environmental Assessment 25
1. Environmental Fate 25
a. Environmental Chemistry, Fate and Transport 25
b. Environmental Fate Assessment 29
2. Ecological Effects 31
a. Ecological Effects Data 31
(1) Terrestrial Data 31
(2) Aquatic Data 33
(3) Non-Target Insects Data 35
(4) Non-Target Plants Data 36
b. Ecological Effects Risk Assessment 36
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 44
A. Determination of Eligibility 44
1. Eligibility Decision 44
2. Eligible and Ineligible Uses 45
B. Regulatory Position 46
1. Tolerance Reassessment 46
2. Restricted Use Classification 46
3. Reference Dose Exceedance 46
4. Risk Mitigation 47
5. Endangered Species Statement 47
6. Labeling Rationale 48
V. ACTIONS REQUIRED BY REGISTRANTS 52
A. Manufacturing-Use Products 52
1. Additional Generic Data Requirements 52
2. Labeling Requirements for Manufacturing-Use Products 53
B. End-Use Products 53
1. Additional Product-Specific Data Requirements 53
2. Labeling Requirements for End-Use Products 54
C. Existing Stocks 57
VI. APPENDICES 59
APPENDIX A. Table of Use Patterns Subject to Reregistration 61
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 67
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of Fenitrothion 79
APPENDIX D. List of Available Related Documents 97
APPENDIX E 99
PR Notice 86-5 101
PR Notice 91-2 119
APPENDIX F. Combined Generic and Product Specific Data Call-In 125
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Attachment 1. Chemical Status Sheets 145
Attachment 2. Combined Generic and Product Specific Data Call-In
Response Forms (Form A inserts) Plus Instructions 149
Attachment 3. Generic and Product Specific Requirement Status and
Registrant's Response Forms (Form B inserts) and Instructions
155
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 165
Attachment 5. EPA Acceptance Criteria 169
Attachment 6. List of All Registrants Sent This Data Call-in (insert) Notice
183
Attachment 7. Cost Share Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 185
APPENDIX G. FACT SHEET 195
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0445 REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Linda Bass/Dave Thomas
Frank Hernandez
Margaret Cogdell
Environmental Fate and Effects Division
Dan Ballaff
Gail Maske
William Schneider
Health Effects Division
Karl Baetcke
John Redden
Al Nielsen
Steve Schaible
Bonnie Cropp-Kohlligian
Registration Division
Beth Edwards
Mark Perry
Special Review and Reregistration Division
Linda Propst
Dennis McNeilly
Carol Stangel
Moana Appleyard
Office of Compliance Monitoring:
Rick Colbert
Biological Analysis Branch
Economic Analysis Branch
LUIS Staff, Biological Analysis Branch
Ecological Effects Branch
Environmental Fate & Groundwater
Branch
Science Analysis and Coordination Staff
Toxicology Branch I
Risk Characterization & Analysis Branch
Occupational and Residential Exposure
Branch
Dietary Risk Evaluation Section
Chemistry Branch II
Insecticide-Rodenticide Branch
Registration Support Branch
Reregistration Branch
Reregistration Branch
Planning and Reregistration Branch
Planning and Reregistration Branch
Agriculture and Ecosystems Division
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11
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GLOSSARY OF TERMS AND ABBREVIATIONS
AE Acid Equivalent
a.i. Active Ingredient
ADI Acceptable Daily Intake. A now defunct term for reference dose (RfD).
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CI Cation
CNS Central Nervous System
CSF Confidential Statement of Formula
DFR Dislodgeable Foliar Residue
ORES 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
GM Geometric Mean
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 as the weight of substance per weight or volume of water, air or feed,
e.g., mg/L, mg/kg or ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50% of the test
animals when administered by the route indicated (oral, dermal, inhalation). It is expressed as a weight of substance
per unit weight of animal, e.g., mg/kg.
LDlo Lethal Dose-low. Lowest Dose at which lethality occurs
LEL Lowest Effect Level
LOG Level of Concern
LOD Limit of Detection
LOEL Lowest Observed Effect Level
MATC Maximum Acceptable Toxicant Concentration
MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate contaminants in
drinking water under the Safe Drinking Water Act.
pg/g Micrograms Per Gram
mg/L Milligrams Per Liter
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MOE Margin of Exposure
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
N/A Not Applicable
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
OP Organophosphate
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method
PHED Pesticide Handler's Exposure Data
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GLOSSARY OF TERMS AND ABBREVIATIONS
PPE Personal Protective Equipment
ppb Parts Per Billion
ppm Parts Per Million
PRN Pesticide Registration Notice
Q*j The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RS Registration Standard
SLN Special Local Need (Registrations Under Section 24 (c) of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD Toxic Dose. The dose 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
WP Wettable Powder
WPS Worker Protection Standard
IV
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EXECUTIVE SUMMARY
This Reregistration Eligibility Decision (RED) document addresses the reregistration
eligibility of the pesticide fenitrothion, 0,0-dimethyl 0-(4-nitro-m-tolyl) phosphorothioate.
Fenitrothion, an organophosphate, is a cholinesterase inhibiting insecticide/acaricide
registered for use on ornamentals, including trees, and in ant and roach baits. Sumitomo
Chemical Co. requested voluntary cancellation of the malaria control uses of fenitrothion on
February 28, 1995. Annual ornamental usage of fenitrothion is very small and appears to be
decreasing. There are no domestic food or feed uses for fenitrothion. The only established
U.S. food additive regulation is for the combined residues of fenitrothion and its metabolites
0,0-dimethyl 0-(4-nitro-m-tolyl)phosphate and 3-methyl-4-nitrophenol in or on wheat gluten
imported from Australia arising from the postharvest application of fenitrothion to stored
wheat grain in that country. The Agency estimates that the dietary exposure to the U.S.
population is 0.000043 mg/kg bwt/day or approximately 3% of the RfD for the general
population, and 8% of the RfD for children aged 1 through 6.
Registered end-use formulations of fenitrothion include a wettable powder, four
emulsifiable concentrate (EC) formulations, and two bait products. The two products,
Sumithion 40 WDP and Sumithion 50 EC (47.5% a.i.), were registered solely for control of
Anopheline mosquitoes transmitting malaria, but as stated above, the registrant has requested a
voluntary cancellation of these products. Although these products had U.S. registrations, they
were never sold or used in this country. Three products are registered for use on
ornamentals: Pestroy 4EC, Pestroy SEC, and Sumithion 8E. Fenitrothion is labeled for
greenhouse use and outdoor use on ornamentals, including trees. Two fenitrothion bait
products, one for roaches (1.0% active) and one for ants (0.01563% active) were registered
on January 9, 1995. These products are labeled for use in and around homes, cabins,
apartment buildings, stores, restaurants, trailers, campers, and warehouses. These uses result
in considerable less human and environmental exposure than the ornamental uses of
fenitrothion. These bait uses for roaches and ants were registered after the human and
ecological risk assessments were conducted. These products are used indoors and would have
negligible ecological impact. Additionally, these uses would result in considerably less human
exposure than the ornamental uses, therefore they are considered eligible for reregistration.
The Agency completed a risk assessment for fenitrothion in September, 1994 that indicated
significant risk to human health and a high potential for adverse ecological effects.
Consequently, the Agency initiated risk mitigation discussions with the sole technical registrant
of fenitrothion, Sumitomo Chemical Company, Limited. This document discusses the
Agency's risk estimate for all registered uses as well as the estimated risk after implementation
of the proposed risk mitigating label revisions.
Margins of exposure (MOEs), a ratio of the estimated exposure level to the No Observable
Effect Level (NOEL), were calculated for all occupational exposure scenarios for which data
were available. MOEs for many fenitrothion uses indicate a significant risk to handlers (i.e.,
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mixers/loaders/applicators). MOEs, for handlers only, were based on all available exposure
data including: (1) chemical specific data submitted by the registrant to support the registration
of fenitrothion; (2) data available in the Pesticide Handlers Exposure Database; and (3) data
from the open literature.
A significant potential for post-application exposure exists from treatment of ornamentals.
The human, non-dietary exposure data used in this risk assessment contain many uncertainties.
Five exposure studies submitted to support reregistration were reviewed by the Agency and
determined to be unacceptable. Due to the uncertainties in the worker exposure data the
Agency is deferring a regulatory decision concerning the low-pressure handwand and
knapsack/backpack methods of application until chemical-specific worker exposure studies are
submitted. Uncertainties in the existing worker exposure database do not allow the Agency to
determine, with confidence, the appropriate MOEs for these exposure scenarios. However,
the Agency believes it is in the public's best interest to implement the human health and
ecological effect exposure/risk mitigation measures negotiated with the registrant. Therefore,
the Agency has decided not to delay issuing the fenitrothion RED until these studies are
submitted and reviewed. The Agency is requiring the registrant to submit the worker
exposure studies for these two scenarios on an accelerated schedule, i.e., one year.
Due to the acute and subchronic toxicity of fenitrothion, the lack of adequate chemical
specific exposure data for all fenitrothion uses, and the low MOEs calculated for
mixer/loader/applicators, high-pressure handwand treatment is the only ornamental use
eligible for reregistration. While the data base is "substantially complete" for the purposes of
making this reregistration eligibility decision, the Agency is requiring the following data as
confirmatory*:
71-1 Acute Oral LD50 for Bobwhite Quail with the major degradate: 3-
methyl-nitrophenol.
71-4 Chronic Toxicity to Birds with the major degradate: 3-methyl-
nitrophenol. (Reserved)
85-4-SS Six Month Ocular Toxicity Study in Dogs (Reserved)
164-1 Terrestrial Field Dissipation
* NOTE: This list of data requirements is based on the assumption that all risk mitigating label changes proposed by Sumitomo
Chemical Company will be implemented.
The following data are required before the Agency can make a regulatory decision
regarding reregistration eligibility for the low-pressure handwand and knapsack/backpack
methods of application:
132-1 (a) Foliar Dissipation
133-3 Occupational Postapplication Dermal Exposure
133-4 Occupational Postapplication Inhalation Exposure
231 Estimation of Dermal Exposure at Outdoor Sites
232 Estimation of Inhalation Exposure at Outdoor Sites
VI
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233 Estimation of Dermal Exposure at Indoor Sites
234 Estimation of Inhalation Exposure at Indoor Sites
These data are considered confirmatory for the high-pressure handwand treatment of
ornamentals. The Agency is requiring these studies to be submitted within one year of receipt
of this RED.
The Agency is requiring "baseline" personal protective equipment (PPE) for applicators
and other handlers for all end-use products containing fenitrothion as follows: coveralls over
long-sleeved shirt and long pants, chemical-resistant gloves, chemical-resistant footwear plus
socks, chemical-resistant headgear for overhead exposures, chemical-resistant apron when
cleaning equipment, mixing, or loading, and a dust/mist filtering respirator with
MSHA/NIOSH approval number prefix TC-21C. The Agency is requiring personal protective
equipment for early entry consisting of coveralls over long-sleeved shirt and long pants,
chemical-resistant gloves, chemical-resistant footwear plus socks, chemical-resistant headgear
for overhead exposures, and chemical-resistant eyewear.
To mitigate the risk to workers entering treated areas after application, the Agency is
requiring a 48-hour restricted-entry interval (REI) for all uses within the scope of the Worker
Protection Standard (WPS). Based on the acute toxicity endpoints for fenitrothion (i.e.,
category II dermal and inhalation), a 24-hour REI would normally be required. However,
because the inhalation NOEL is low (i.e., 0.049 mg/kg/day) and there are no acceptable
inhalation data with which to adequately assess the REI, the Agency has decided to require a
48-hour restricted-entry interval and upgrade the personal protective equipment specified for
early-entry until acceptable data become available to assess each use pattern of interest. The
48-hour REI is increased to 72 hours when any product containing fenitrothion is used in
outdoor areas where the average rainfall is less than 25 inches a year. Uses within the scope
of the WPS include all commercial (non-homeowner) and research uses of fenitrothion used to
produce agricultural plants (including ornamentals).
Except for the terrestrial field dissipation (164-1) and wildlife toxicity data for
fenitrothion degradates, all ecological effects and environmental fate guideline data needed to
support the reregistration of fenitrothion on ornamentals in greenhouses and nurseries have
been submitted.
Technical grade fenitrothion is highly toxic to birds and aquatic invertebrates, and chronic
effects were observed in an avian reproduction study. Fenitrothion is also moderately toxic to
mammals. Outdoor uses of fenitrothion exceed the hazard limits established in 40 CFR
152.170 for restricted-use classification. Therefore, the Agency will require all fenitrothion
products labeled for outdoor use to be labeled for restricted use only. Of all the registered
uses for fenitrothion, the use for Christmas tree plantations and the basal bark treatment result
in the greatest potential for exposure to non-target species. The registrant has proposed
deleting these uses from the label. For the remaining ornamental uses, the registrant has
proposed significant label revisions to reduce ecological risk. The application rate is reduced
vn
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on a per acre basis to 0.3125 Ib ai/acre, the maximum number of applications is reduced to
three per year, and the minimum interval between applications is increased to one month. In
addition, all broadcast application will be removed form the label and use will be restricted to
spot treatments.
The Agency has determined that outdoor uses of fenitrothion, especially the Christmas tree
plantation use, poses a high acute risk to endangered mammals, birds and aquatic
invertebrates. In addition, fenitrothion poses a chronic risk to birds and aquatic invertebrates.
The Agency has determined that only the high-pressure handwand treatment of ornamentals
and bait uses are eligible for reregistration. The Agency is deferring a regulatory decision
concerning the low-pressure handwand and knapsack/backpack methods of application until
chemical-specific worker exposure studies are submitted. The technical registrant has stated
they will cancel voluntarily uses that were assessed by EPA as posing high ecological risk,
i.e., Christmas tree farm, basal bark treatments, and ornamental broadcast treatments.
Restricted use labeling will ensure that fenitrothion is used only by certified applicators or by
applicators under their supervision.
In addition, before reregistering products containing fenitrothion, 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.
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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 fenitrothion. The document consists of six sections. Section I is the
introduction. Section II describes fenitrothion, 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 fenitrothion.
Section V discusses the reregistration requirements for fenitrothion. 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: Fenitrothion
Common Name: Fenitrothion
Chemical Name: 0,0-dimethyl 0-(4-nitro-m-tolyl) phosphorothioate.
,
H C" ~^ O I OCH
3 OCH
'3
Chemical Family: Organophosphate
CAS Registry Number: 122-14-5
OPP Chemical Code: 105901 (OPP: Office of Pesticide Programs)
Empirical Formula: C9H12N05PS
Trade and Other Names: Sumithion, Pestroy, Accothion, Agrothion, Bayer
41831, Bayer S 5660, Cytel, Dybar, Fenitox,
MEP, Novathion, Nuvanol, Cyfen
• Basic Manufacturer: Sumitomo Chemical Co. LTD., Osaka, Japan
(Fenitrothion is not manufactured in the U.S.)
B. Use Profile
The following is information on the current registered uses of fenitrothion with
an overview of use sites and application methods. A detailed table of these uses of
fenitrothion is in Appendix A. Appendix A summarizes current use patterns; it does
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not include label revisions proposed by the registrant to mitigate human health or
ecological risks. These label revisions are discussed in detail in Sections IV and V.
Type of Pesticide: Nonsystemic organophosphate insecticide and acaricide
Use Sites: Terrestrial and greenhouse non-food crops (ornamentals) including
ornamental and/or shade trees. The registrant requested (Feb 28, 1995)
voluntary cancellation of the malaria control uses of fenitrothion. This use
involved treatment of the interior of domestic, commercial, institutional, and
industrial buildings.
Two fenitrothion bait products were recently registered, one for roaches
(1.0% active) and one for ants (0.01563% active). These products are labeled
for use in and around homes, cabins, apartment buildings, stores, restaurants,
trailers, campers, and warehouses. See Appendix A for details on registered
uses.
Target Pests: Ants, cockroaches (including waterbugs and palmetto bugs),
aphids, bagworm, iris borer, spruce budworm, fall cankerworm, forest and
eastern tent caterpillers, Eotetranychus mites, gypsy moth, lacebugs, leaf
beetles, azalea and birch leafminers, citrus mealybug and white flies, balsam gall
midge, eriophyid mites, southern red mite, palmerworm, boxwood and
hackberry psyllids, pine tipmoth, sawflies, scale insects, spittlebugs, slugs, fall
webworm, black vine weevil, northern pine and pales weevils.
Formulation Types Registered: 0.01563% and 1% baits, 45% EC, 76.8%
EC.
Method and Rates of Application:
Equipment - Ground-based and hand-held equipment.
Method and Rate - Applications are made to run-off on various nonfood plants
(ornamentals) using up to 100 gallons of spray solution per acre at
concentrations ranging from approximately 0.12% up to 2% active ingredient
(w/v). Basal bark treatments are to be repeated every 90 days while spot
treatments and broadcast applications can be repeated every 7 days. The
application rates are the same regardless of whether the site is a greenhouse or a
commercial tree lot.
Note: Sumitomo Chemical Company has proposed significant label changes for
fenitrothion use, including voluntary cancellation of malaria control uses.
- Principle application times are during late spring and early summer.
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C. Estimated Usage of Pesticide
Annual ornamental usage of fenitrothion in the U.S. is very small and appears to be
decreasing. The available production figures and information from the registrant both
indicate that considerably less than 1% of the nursery land in the U.S. is treated
annually with Sumithion 8E, Pestroy 4E or Pestroy 8E (fenitrothion end-use products).
Sumithion 40 WDP and 50 EC products for malaria control are not sold in the U.S.
and their registrations are being voluntarily cancelled. These products are sold and
used in Central America, South America, Asia, Africa and the Caribbean. These
estimates are derived from a variety of published and proprietary sources available to
the Agency.
D. Data Requirements
Data requested in the July 1987 Registration Standard for Fenitrothion included
studies on product chemistry, toxicology, ecological effects, environmental fate, residue
chemistry, and occupational/residential exposure. Because fenitrothion is an
organophosphate, a DCI was also issued on June 28, 1991 requiring neurotoxicity data to
satisfy data requirements for Guidelines: 81-8-SS, 82-5(b), and 85-7-SS. These data were
required to support the uses listed in the 1987 Fenitrothion Registration Standard.
Appendix B includes all data requirements identified by the Agency for the only registered
use remaining after voluntary cancellation, ant and roach baits and use on ornamentals in
greenhouses and nurseries.
E. Regulatory History
Fenitrothion was first registered under FIFRA in the United States in 1975. The
registration was for control of spruce budworm in forests under the supervision of federal
and state officials responsible for insect control programs in forest areas. In November
of 1992, at the request of the registrant, all of the fenitrothion products bearing forestry
uses were cancelled. Fenitrothion is used in the U.S. for commercial ornamental pest
control. The registrant has requested voluntary cancellation of the mosquito control
products (i.e., malaria control).
A Data Call-In (DCI) was issued in 1984 requiring additional toxicity data concerning
the chronic toxicity of fenitrothion. A Registration Standard for Fenitrothion was issued
in July 1987 (NTIS #PB88-191697) which evaluated the studies submitted as a result of
the 1984 DCI. This Reregistration Eligibility Decision reflects a reassessment of all data
which were submitted in response to the Registration Standard and the June 1991 DCI.
As a result of the Registration Standard review, the Agency determined that certain
additional or revised label restrictions were necessary. An interim 24-hour reentry
interval was imposed for greenhouse and nursery ornamental uses, until appropriate
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reentry data were submitted and evaluated. The Agency also imposed a restricted-use
classification on the forestry uses of fenitrothion until receipt and review of comprehensive
aquatic and terrestrial studies. Subsequently, in 1992 the forestry uses of fenitrothion
were cancelled. Labeling was required to reflect the high toxicity to birds, honeybees, and
aquatic invertebrates. Precautions were also imposed to protect potentially exposed
endangered species. Two bait products, one for roaches (1.0% active ingredient) and one
for ants (0.01563% active ingredient) were registered in January 1995.
Through implementation of the labeling requirements of the 1992 Worker Protection
Standard for Agricultural Pesticides (WPS), the 24-hour interim reentry interval
(permitted routine entry to perform hand labor tasks if PPE is worn) was converted to a
2 4-hour interim restricted entry interval (prohibits routine entry to perform hand labor
tasks even if wearing PPE). Uses within the scope of the WPS include all commercial and
research use of fenitrothion to produce agricultural plants. Fenitrothion pest bait products
(ant and roach) fall outside the scope of WPS.
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III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
All pertinent product chemistry data requirements are satisfied for the fenitrothion
95% T registered to Sumitomo Chemical America, Inc. (EPA Reg. No. 39398-4).
1. Identification of the Active Ingredient
Fenitrothion [0,0-dimethyl 0-(4-nitro-m-tolyl) phosphorothioate] is a
cholinesterase inhibiting insecticide/acaricide. The molecular structure of
fenitrothion is shown on page 2. Other pertinent information for fenitrothion
follows:
Empirical Formula: C9H12N05PS
Molecular Weight: 277.2
CAS Registry No.: 122-14-5
PC Code: 105901
Technical fenitrothion is a yellowish-brown oil which decomposes at 140-
145°C (at 0.1 mmHg) and has a specific gravity of 1.32-1.34. Its solubility in
water at 20°C and 30°C is 5 mg/kg and 14 mg/kg, respectively. Fenitrothion
solubility at 22-25°C in methanol and acetone is > 50% w/w and in hexane is
< 10% w/w.
B. Human Health Assessment
1. Toxicology Assessment
The toxicological data base for fenitrothion is adequate and will support
reregistration. The requirement to conduct a six month ocular toxicity study in
dogs is reserved until the Agency develops protocols for the testing. A
replacement acute inhalation study was submitted to the Agency on December 13,
1994. This study is in review.
a. Acute Toxicity
Acute toxicity data on fenitrothion are summarized in the Table below:
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Acute toxicity summary for fenitrothion.
TEST
81-1: Oral LD50
Sumithion Technical (97.2%)
81-2: Dermal LD50
Sumithion Technical (97.2%)
81-3: Inhalation LC50
Sumithion 8-E (77% a.i.)
81-4: Eye effects
Sumithion 8-E (77% a.i.)
81-5: Dermal Irritation
Sumithion 8-E (77% a.i.)
81-6: Dermal Sensitization
Sumithion Technical (97.2%)
81-8: Neurotoxicity-acute delayed: hen
Sumithion Technical (97.2%)
81-8-SS Neurotoxicity Screen: rat
Fenitrothion Technical (94.3%)
RESULT (mg/kg)
LD50 = 330 mg/kg (M), LD50 = 800
mg/kg (F)
LD50 = 890 mg/kg (M), LD50 = 1200
mg/kg (F)
LC50 = 5.0 mg/1
PIS = 0.1/1 10 at 72
hrs., PIS = 0/1 10 at 7 days.
PIS = 2.75 (mild irritant)
Animals treated with 0. 1 ml of 5% and
1% sumithion - results negative
Mortality - 3/16 after first
administration; 3/13 after second
administration; Negative at 500 mg/kg
NOEL and LEL = 12.5 and 50 mg/kg
for males in the study. NOEL could not
be determined for the females.
CATEGORY
II
II
*
II
III
III
N/A
N/A
N/A
* Unacceptable study, a new study was received on December 13, 1994.
The data summarized in the acute toxicity Table (Section B.I.a.) indicate that fenitrothion
presents a potential acute health hazard.
Because of the numerous deficiencies in the 81-3 acute inhalation LC50 study, a
replacement study was submitted and is now in review. The original study was not
conducted with the technical grade material. Although the LC50 was reported as greater
than 5 mg/L, only the nominal concentration was reported, making it difficult to assign
the proper toxicity category (the nominal concentration can be significantly larger than the
analytically determined concentration). In addition, the individual animal data were not
reported. Due to the inadequacies in the acute inhalation LC50 study (81-3) the toxicity
category was moved from category IV to toxicity category II.
b. Subchronic Toxicity
Guideline 82-1, 90-day feeding-rodent, is satisfied by the two
year chronic feeding/oncogenicity study (see c. & d. Chronic
Toxicity, Carcinogenicity). Guideline 82-1, a 90-day feeding-
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nonrodent, is satisfied by the one-year dog feeding study. (MRIDs
00071965, 254868)
In a 21-day dermal study (Guideline 82-2), fenitrothion (93.7%)
was applied to the skin of New Zealand white rabbits. The dose
levels were 0, 3, 10, 50 or 250 mg/kg/day. The Systemic NOEL
equals 3 mg/kg/day and the Systemic LOEL equals 10 mg/kg/day
based on inhibition of plasma cholinesterase (40%) and brain (20%)
cholinesterase in females. The dermal NOEL was not determined.
The dermal LOEL is 3 mg/kg/day based on dermal irritation and
desquamation of the epidermis. (MRID 42058301)
In a 90-day inhalation study (Guideline 82-4), Crl (WI) BR strain
rats were exposed to 0, 0.2, 1.0, or 10 jig/1 of Sumithion
Technical (94.5%). At the 10 jig/1 exposure level, plasma
cholinesterase activity in males and red blood cell (RBC)
cholinesterase activity in males and females was inhibited. Brain
cholinesterase was inhibited in females at 1 jjg/1 and 10 Jig/1. A
NOEL of 0.2 jjg/1 was determined on the basis of brain
cholinesterase inhibition in females. (MRID 40891001)
c. Chronic Toxicity
A two-year chronic feeding/oncogenicity study was conducted in
the Charles River/CD strain rat. The compound was administered
in the diet at doses of 0, 0.5, 1.5 or 5 mg/kg/day (0, 10, 30 or 100
ppm). The cholinesterase LEL equals 10 ppm (LDT) (brain and
plasma). (MRID 00071965)
A 22-month chronic feeding/oncogenicity study was conducted
in the Wistar strain rat. The compound was administered in the diet
at doses of 0, 0.125, 0.25, or 0.5 mg/kg/day (0, 2.5, 5.0 or 10
ppm). The systemic NOEL is 10 ppm; the systemic LOEL is > 10
ppm. The cholinesterase NOEL is 2.5 ppm; the cholinesterase
LEL is 5.0 ppm (plasma). At 10 ppm, RBC cholinesterase was
reduced. (MRID 40420501)
A two-year chronic feeding/oncogenicity study was conducted in
B6C3F1 mice. The compound was administered in the diet at 0, 3,
10, 100, or 1000 ppm (0, 0.45, 1.51, 13.07, or 144.32 mg/kg/day
for the females, and at 0.37, 1.45, 12.62, or 134.28 mg/kg/day for
the male). The study was conducted at adequate dosage based on
a 26-29% suppression in body weight gain at 1000 ppm (both sexes)
and a depression of cholinesterase observed at 100 and 1,000 ppm
8
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(both sexes). The systemic NOEL is 3 ppm (0.45 mg/kg/day);
systemic LEL is 10 ppm (1.45 mg/kg/day) based on decreased body
weight gains, decreased RBC, brain, and plasma cholinesterase
activity. (MRIDs 41925201, 42507701 and 41507704)
A one-year feeding study was conducted in beagle dogs. The
compound was administered in the diet at 0, 5, 10, or 50 ppm (0,
0.125, 0.25, or 1.25 mg/kg/day). The cholinesterase NOEL is 5
ppm; cholinesterase LEL is 10 ppm (plasma cholinesterase
inhibited); systemic NOEL is 5 ppm; and systemic LEL is 10 ppm
(increased incidence of abdominal lymph node hemorrhage).
(MRID 254868)
d. Carcinogenicity
Fenitrothion has been classified by the RfD committee on the
basis of its carcinogenic potential in Group E - evidence of non-
car cinogenicity for humans.
e. Developmental Toxicity
A developmental toxicity study was conducted with pregnant
Sprague-Dawley rats which were administered 0, 3, 8 or 25
mg/kg/day fenitrothion from day 6 through day 15 of gestation.
The maternal NOEL equals 8 mg/kg/day, and the maternal LEL
equals 25 mg/kg/day based on a decrease in the percentage body
weight gain and the absolute body weight (days 11 through 19 of
gestation), decreased mean corrected terminal body weight and
tremors in 9 of the 24 females. The Developmental NOEL equals
8 mg/kg/day, and the Developmental LEL equals 25 mg/kg/day
based on an increased incidence of fetuses and litters with one full
and one rudimentary 13th rib. (MRID 40604002)
A developmental toxicity study was conducted with HRA:
(NZW) SPF strain rabbits. The compound was administered by
gavage at doses of 0, 3, 10 or 30 mg/kg. The maternal NOEL is
10 mg/kg/day, and the maternal LEL is 30 mg/kg/day (increased
mortality, abortion, tremors, ataxia and dyspnea and reduced body
weight gain). The developmental NOEL is 30 mg/kg/day (HOT).
(MRIDs 264497, 00162548, and 40430601)
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f. Reproductive Toxicity
A 2-generation reproduction study was conducted with Sprague-
Dawley (Crl:COBS CD SD BR) rats. Fenitrothion was
administered by gavage in a corn oil vehicle at doses of 0, 10, 40,
or 120 ppm (Male: 0.68, 2.74, or 8.40 mg/kg/day; Female: 0.77,
3.19 or 10.37 mg/kg/day). The parental toxicity NOEL is 40 ppm
based on the following observations: 1) decreased food
consumption, body weight and weight gain in both generations and
sexes at 120 ppm. The parental toxicity LEL is 120 ppm. The
reproductive toxicity NOEL is 40 ppm based on the following
observations: 1) decreased fertility in the F0; and decreased
numbers of implantation sites, decreased viability and lactation.
The reproductive LEL is 120 ppm. The HED RfD/Peer Review
Committee (July 13, 1993) concluded: "... the data do not indicate
treatment-related change in the fertility indices." (MRIDs
41689001, and 42668801)
g. Mutagenicity
A Gene Mutation Assay (Ames Assay) was conducted using
fenitrothion technical (98.6%). Doses ranged from 100 to 2000
jig/plate. Fenitrothion is mutagenic in Salmonella typhimurium
strain TA100 with S-9 activation, but not mutagenic in the
nitroreductase deficient strain TA100 with S-9 activation. The
selected dose range was adequate for demonstrating a mutagenic
effect in TA100, but the results indicate a false-positive response
associated with bacterial nitroreductase activity. Since mammals
lack the type of nitroreductase found in bacteria, fenitrothion is not
considered to be a potential mammalian mutagen. (MRID
00163432)
A Chromosome Aberration in vitro study with CHO cells was
conducted using fenitrothion. Fenitrothion was found to be
negative in Chinese hamster cells treated up to cytotoxic and
insoluble levels, 300 jig/ml with and without S9 activation. (MRID
40789201)
An Unscheduled DNA Synthesis Assay with rat hepatocyte study
was conducted using fenitrothion (96.7%). Fenitrothion was found
to be positive for inducing unscheduled DNA synthesis (UDS) in
primary rat hepatocyte cultures, but only at the HOT, 30 jig/ml, a
cytotoxic dose (60-70% relative cell viability). (MRID 40789202)
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h. Metabolism
C14-fenitrothion administered to male and female Wistar rats,
male and female rabbits, or male beagle dogs as a single dose of 15
mg/kg was absorbed rapidly and excreted nearly to completion in
48 hours with approximately 90% and 5% of the excreted dose
eliminated in the urine and feces, respectively. Expired air from
rats contained no radioactivity; C14 levels in the tissues were not
measured. There were no sex- or species-related differences in the
total excretion. A single oral dose (105 mg/kg) in rats with labeled
fenitrothion for 5 days did not alter the excretion profile.
Seventeen metabolites were isolated in the urine of rats, rabbits,
and dogs, but only eight were identified. The parent compound
was not detected in the urine of any animal. In the feces, no
metabolites other than those found in the urine were present.
(MRIDs 00069960, 40408906)
The urinary metabolites of fenitrothion have been identified in
the male and female rat. The fecal metabolites have been identified
in the male but not the female rat. The major metabolic routes
appear to be (1) the demethylation of the phosphate moiety, (2)
desulfuration of the phosphate moiety and (3) the hydrolysis of the
phosphate moiety from the phenyl moiety as reflected by the types
of metabolites found in the urine and feces. The pattern of
distribution and elimination of fenitrothion in male and female rats
was similar regardless of receiving a single nontoxic dose (15
mg/kg) exposure, a single toxic dose (105 mg/kg) exposure or
repeated nontoxic dose exposure (15 mg/kg every other day for 5
times, and then treated with 15 mg/kg of radiolabeled fenitrothion).
Fenitrothion is excreted in the urine (95% of total dose) and in the
feces (about 5% of the remaining dose) within 7 days of exposure.
Fenitrothion and/or its metabolites were not detected in the expired
air of either male or female rats. No major sex differences were
observed in the distribution, metabolism or the excretion of
fenitrothion.
i. Other Toxic Endpoints
An acute ocular toxicity study was conducted with Sprague-
Dawley (SD) (Crj:CD) rats using fenitrothion (94.5%). Doses
were administered by oral gavage at the following levels: 0, 20, or
200 mg/kg for males, and 0, 40, or 400 mg/kg for females. The
cholinesterase NOEL could not be determined. The cholinesterase
LOEL was less than 20 and 40 mg/kg (LDT) based on erythrocyte
11
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cholinesterase inhibition in male and female rats, respectively. The
ocular NOEL is greater than 200 mg/kg for males, and 400 mg/kg
for females, based on lack of changes clearly related to treatment
in electroretinography (ERG) and ophthalmic examination of the
anterior portions of the eye. The ocular LOEL was not
determined. No residual effect was observed on the
electroretinograph following doses which produced signs of toxicity
and were accompanied by depression of plasma and erythrocyte
cholinesterase activity. No indications of ocular toxicity were
observed. (MRID 41249601)
A 13-week subchronic study was conducted with Sprague-
Dawley (SD) (Crj:CD) rats using fenitrothion (94.5%). Doses
were administered in the feed at the following doses: 0, 2.5, 5, 10
or 30 ppm (Males: 0, 0.14, 0.282, 0.570 or 1.70 mg/kg/day;
Females: 0, 0.169, 0.331, 0.648, or 1.96 mg/kg/day). The
cholinesterase NOEL is 5 ppm based on a statistically significant
inhibition of plasma cholinesterase in female rats to approximately
54% of the control activity levels. In addition, at 30 ppm,
statistically significant inhibition of plasma, erythrocyte and brain
cholinesterase was observed in female rats, and of plasma and
erythrocyte cholinesterase in male rats. (MRID 41249602)
No effect was observed on the ERG at the end of dosing either
in comparison to pretreatment values or in comparison to
concurrent control values. The high dose showed depression of
plasma, erythrocyte and brain cholinesterase at the end of the study.
The study showed no evidence of ocular toxicity.
A six month ocular toxicity study in dogs, required in the 1991
Data Call In, is in a reserved status until a test protocol is
developed.
Reference Dose
The Agency concluded that an RfD should be established based
upon a NOEL of 0.125 mg/kg/day for systemic effects (histo-
pathological changes in lymph nodes) and plasma cholinesterase
inhibition observed at 0.25 mg/kg/day in a long-term feeding study
in dogs. An Uncertainty Factor (UF) of 100 was used to account
for the inter-species extrapolation and intra-species variability. On
this basis the RfD was calculated to be 0.0013 mg/kg/day.
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The Joint FAO/WHO Meeting On Pesticide Residues (JMPR)
reports an ADI of 0.005 mg/kg bw (1988). (Pesticide Residues In
Food - 1988. Report of the Joint Meeting of the FAQ Panel of
Experts on Pesticide Residues in Food and in the Environment and
a WHO Expert Group on Pesticide residues. FAQ Plant Protection
and Production Paper 92, 1988.)
2. Exposure Assessment
a. Dietary Exposure
Plant Metabolism
The qualitative nature of the residue in wheat grain is understood
adequately based upon available rice metabolism/degradation data.
Data indicate that fenitrothion per se, desmethyl fenitrothion, and
p-nitrocresol are the major components of the residue. Additional
metabolites retaining the aryl phosphate or phosphorothioate moiety
which were present in very small amounts (i.e., collectively < 3%
of the TRR in rice grain) were fenitrooxon, fenitrothion S-isomer,
desmethylfenitrooxon, and desmethylfenitrothion S-isomer. The
HED Metabolism Committee has determined that the food additive
regulation for residues in wheat gluten should be in terms of the
parent compound only. No additional data are required.
Residue Analytical Methods - Plants
A GLC method, which was published and described in the
Journal of Agriculture and Food Chemistry 17:271-276, has been
deemed adequate for data collection and enforcement purposes. A
successful EPA method tryout (MTO) was conducted on wheat
gluten using the preferred GLC method. Although certain
inconsistences in the EPA method tryout (MTO) reports were
identified, they are irrelevant to the method's adequacy for data
collection and enforcement purposes. The method will be published
in PAM Vol. II.
Residues of fenitrothion have been subjected to multiresidue
protocols required in the 40 CFR 158.125(b)(15) and published in
the Addendum to Pesticide Assessment Guidelines Subdivision 0 -
Residue Chemistry Data Requirements Multiresidue Protocols.
Fenitrothion is adequately recovered using FDA multiresidue
analytical methods.
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Storage Stability
The available storage stability data indicate that residues of
fenitrothion are stable under frozen (-18°C) storage conditions
in/on wheat and wheat gluten for up to 147 and 174 days,
respectively. These data are adequate to support the available
residue data.
Magnitude of the Residue in Plants
All data requirements for the magnitude of the residue in plants
have been evaluated and deemed adequate with the assumption that
the magnitude data which have been submitted to the Agency
adequately reflect the maximum registered use rate of fenitrothion
on stored wheat in Australia. All data requirements for the
magnitude of the residue in wheat gluten as a result of the
postharvest application of fenitrothion to stored wheat in Australia
have been evaluated and deemed adequate. No additional data are
required.
Animal Data Requirements
Fenitrothion is not registered for use on any domestic crop;
therefore, residues of fenitrothion are not expected to enter the diet
of food animals. In the event that future registrations for use of
fenitrothion on plant commodities used for animal feeds are
approved, or regulations are established covering importation of
animal products from countries in which fenitrothion is registered
for use, additional data may be required.
b. Occupational and Residential Exposure
An occupational and/or residential exposure assessment is
required for an active ingredient if (1) certain toxicological criteria
are triggered and (2) there is potential exposure to handlers
(mixers, loaders, applicators, etc.) during use or to persons entering
treated sites after application is complete.
(1) Use Summary
Fenitrothion applications to ornamentals in greenhouses/outdoors
can be made using ground-based and hand-held equipment. Such
equipment includes, but is not limited to, the following:
14
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groundboom; low-pressure handwands; high-pressure handwands;
knapsack/backpack sprayers; overhead boom sprayers; liquid
broadcast spreaders; and powered personal sprayers.
Application methods for outdoor terrestrial and greenhouse
scenarios include: basal bark treatments, broadcast applications, and
spot treatments. Basal bark treatments can be repeated every 90
days while spot treatments and broadcast applications can be
repeated every 7 days. Applications are made to run-off on various
ornamental plants (non-food) using up to 100 gallons of spray
solution per acre at spray solution concentrations ranging from
approximately 0.12% up to 2% active ingredient (w/v).
Indoor residential use sites include ant/roach baits and mosquito
control uses. The registrant has requested (Feb 28, 1995) voluntary
cancellation of mosquito control uses.
(2) Summary of Toxicity Concerns Impacting Occupational
Exposures
Acute Toxicity
The Agency has determined that the appropriate short-term
endpoints to use for occupational risk assessments are the NOELs
from the 21-day dermal toxicity study and the 90-day inhalation
study for inhalation exposure. Due to the inadequacies with the
acute inhalation study the toxicity category was moved from
categories IV to toxicity category II. The inhalation study has been
resubmitted and is currently in review. Fenitrothion is not a
sensitizer. The vapor pressure for fenitrothion is low (2.14 X 10 4
mmHg @ 25 C).
Other Adverse Effects
The Agency has determined that the primary occupational route
of exposure to fenitrothion is dermal. On this basis, the Agency
determined that the most appropriate NOEL to establish a dermal
margin of exposure is from the 21-day dermal study in rabbits.
The systemic NOEL in this investigation was 3 mg/kg/day based on
40% inhibition of plasma cholinesterase in both sexes and 20%
inhibition of brain cholinesterase in females, observed at 10
mg/kg/day. Clinical signs indicative of cholinesterase inhibition
were observed at 250 mg/kg/day (HDT) in this study. (MRID
42058301)
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A 90-day inhalation study was conducted with rats exposed to 0,
0.2, 1.0, or 10 jjg/l of technical grade material (94.5%). The 0.2
jjg/1 NOEL from this investigation was selected to estimate the
MOE for the occupational inhalation exposure component. The 1.0
jjg/1 LEL was based on inhibition of plasma cholinesterase in males
and RBC cholinesterase in males and females. (MRID 40891001)
Additional evidence of cholinergic inhibition was found in the
81-8-SS Acute Oral Neurotoxicity Study in rats in the form of
clinical signs. The NOEL of 12.5 mg/kg/day was based on
tremors, ataxia, gait capacity, and decreases in body temperature
and motor activity observed at 50 mg/kg/day. This investigation
did not assess cholinesterase enzyme activity as recommended in the
neurotoxicity test guidelines. If the cholinesterase had been
monitored in this investigation, the NOEL for neurotoxicity may
have been lower than 12.5 mg/kg/day. Clinical signs of cholinergic
inhibition were also observed in an oral developmental toxicity
study in rabbits. The maternal NOEL of 10 mg/kg/day was based
on mortality, abortion, tremors, ataxia, dyspnea, and reduced body
weight gain at 30 mg/kg/day. Since it can be presumed that ChE
inhibition occurred at lower levels than those which resulted in
cholinergic signs in the acute neurotoxicity study, it is reasonable
to assume a single dermal exposure could produce the effects noted
at 10 mg/kg in the 21-day dermal study and that the NOEL of 3
mg/kg is appropriate to use for estimating risk following a single
dermal exposure. When considered together, the acute oral and 21-
day dermal studies indicate maximum ChE inhibition occurs within
one to several days and that 100% absorption can be assumed for
the dermal route. (MRIDs 42666901, 40430601)
(3) Summary of Potential Occupational Exposures
The dermal and inhalation exposures may be acute, intermittent, or
chronic.
Handlers (Mixers, Loaders, Applicators, etc.) Exposures: The
Agency has determined that there is an exposure potential for
handlers (mixers, loaders, applicators, etc.) during the usual use-
patterns associated with fenitrothion. Exposures to mixer, loaders
and applicators are likely when fenitrothion is applied to
ornamentals both outdoors or in greenhouses.
Post-Application Exposures: The Agency has determined that
there is a potential for an exposure risk for persons entering treated
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sites after application is complete. Post-application exposures are
likely following applications to ornamentals outdoors and in
greenhouses.
(4) Handler (Mixers, Loaders, Applicators, Etc.) Exposures
& Assumptions
Based on the toxicological endpoints and the significant potential
for exposure, fenitrothion continues to meet the Agency's criteria
for the requirement of mixer/ loader/applicator exposure data.
Mixer/loader/applicator and indoor air residue exposure data were
required by the Fenitrothion Registration Standard (1987).
The following documents were submitted to the Agency in
support of Subdivision U requirements for the reregistration of
fenitrothion:
• Safe Use of Pesticides; Third Report of the World Health
Organization (WHO) Expert Committee on Vector Biology and
Control—Fenitrothion Aspects Excerpted From WHO Technical
Report Series 634 (MRID 40408928),
• Determination of Urinary Metabolites as a Measurement of
Exposure of Spraymen and Householders to Fenitrothion and
Malathion in Haiti—Presented at the 23rd Meeting of the
Collaborative International Pesticide Analytical Council/Sponsored
by the Vector Biology and Control Division, Bureau of Tropical
Diseases, Centers for Disease Control (MRID 40408929), and
• Exposure of Mixer/Loader/Applicators to Pestroy (fenitrothion)
Insecticide Applied to Ornamentals by Hand-Held Spraygun
Equipment (MRID 41096301). [Note: An addendum was submitted
for this study (i.e., MRID 42970301, Representative
Chromatograms and Analytical Data To Supplement Study of
Exposure of Mixer/Loader/Applicators to Pestroy (Fenitrothion)
Insecticide Applied by Hand-Held Spraygun Equipment, 1988.]
These documents were each reviewed by the Agency and
determined to be unacceptable. The WHO and CDC studies were
considered unacceptable because of the study design, the level of
detail provided therein, and the associated lack of quality
control/quality assurance regimens during the biological monitoring
of workers. Additionally, the Mixer/Loader/Applicator exposure
study is unacceptable because of several major inadequacies:
17
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quality control/quality assurance regimen was inadequate and the
label specified PPE requirements were not adhered to in the study
design; storage stability data were not provided and field
fortification data were inadequate to support the submission; and
insufficient data were provided regarding the cultural practices
associated with fenitrothion use on ornamentals; and the addenda
submitted by the registrant did not upgrade the acceptability of the
original data. (MRIDs 41096301, 42970301)
The WHO and CDC studies are not upgradable in order to
satisfy the requirements specified in Subdivision U. The chemical
specific mixer/loader/applicator exposure study (MRID 41096301)
and the associated addenda (MRID 42970301) also do not currently
meet the criteria specified in Subdivision U. However, because the
mixer/loader/applicator exposure study is upgradable by correcting
the deficiencies cited above, the data were utilized for an exposure
assessment and corresponding MOE values were calculated based
on these data.
Based on the use patterns described above, several handler
exposure scenarios are possible given the various types of
application equipment and procedures that might be employed by
fenitrothion users. Typical equipment used to treat ornamentals (in
greenhouses and in outdoor nurseries) were considered in this
assessment. The Pesticide Handlers Exposure Database was used
for all exposure estimates except for mixing/application using a
high pressure handwand. The data for this scenario were chemical-
specific data submitted to support the reregistration of fenitrothion
(MRIDs 41096301, 42970301).
All exposure values presented in this RED are based on the
assumption that fenitrothion handlers are wearing the following
personal protective equipment: coveralls worn over short-sleeved
shirt and short pants; socks plus shoes; chemical resistant gloves;
and a respirator with a protection factor of 5 (i.e., disposable
dust/mist mask). For several scenarios, exposure data for the exact
clothing/PPE ensemble requirements were not available. As a
result, the Agency applied standard protection factors to each data
set to normalize the data in order to represent the standard
clothing/PPE ensemble as closely as possible.
Various uncertainties and caveats must be considered when
completing any risk assessment of this nature. In fact, a majority
of the exposure data used in this assessment were questionable due
18
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to inadequate quality control data and/or an inadequate number of
replicates to sufficiently assess each scenario. These considerations
must be acknowledged during the interpretation of the exposure
assessment. All potential mixer/loader/applicator exposure
scenarios and any available data are presented below.
Daily exposure is calculated using the following formula:
Daily exposure (mg ai/kg bw/day)
= unit exposure(mg ai/lb ai) x use(lb ai/A) x Daily Acres Treated (A/day)
body wt (kg)
Summary Exposure Values Which Conform to the WPS Clothing Requirements For
Fenitrothiona. This table discusses labeled uses prior to risk mitigation.
Exposure Scenario
Daily Dermal Exposure
(mg/kg/day)
Daily Inhalation
Exposure (mg/kg/day)
Mixer/Loader Exposures3
Open Mixing Wettable
Powders
Open Mixing
Liquids
0.022
0.26
0.000038
0.00014
Applicator Exposures
Low Pressure Handwand
Application
High Pressure Handwand
Application
0.31
0.10
0.00023
0.000015
Mixer/Loader/Applicator Exposures
Mixing and Application with
Low Pressure Handwands
Knapsack/
Backpack Application
Mixing and Application with
High Pressure Handwand
2.65
0.20
0.22
0.00040
0.00062
0.00338
a Reported mixer/loader exposure levels represent the maximum amount of chemical
which can be handled on a daily basis.
These daily exposures to fenitrothion by handlers are used to assess the risk to those
handlers.
19
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(5) Additional Occupational Exposure Studies
Foliar residue dissipation along with post-application dermal and inhalation exposure
data were required in the 1987 Fenitrothion Registration Standard. Data submitted by the
registrant were inadequate to calculate post-application exposures for any of the
appropriate use sites described above for fenitrothion. Based on the toxicological
endpoints and the significant potential for exposure, fenitrothion continues to meet the
Agencies' criteria for the requirement of post-application exposure/residue dissipation
data.
The following post-application exposure scenarios are of concern to the Agency: (1)
greenhouse worker exposure after treatment of ornamental plant beds and potted plants;
and (2) outdoor worker exposure after contact with treated ornamental plants and foliage.
Exposures After Applications to Ornamentals: No actual exposure data were
generated to support reregistration of fenitrothion for use on ornamentals in outdoor or
greenhouse sites. The registrant submitted theoretical determinations of exposure potential
based solely on a subjective assessment of agricultural and pesticide application practices.
Adequate QA/QC data were not included. In addition, the determination of the leaf area
of elm saplings was inconclusive, the estimation of fenitrothion half-life in the report was
not justified, and inhalation exposure potential was ignored.
Exposures After Applications to Residences: The registrant has requested (Feb 28,
1995) voluntary cancellation of all malaria control uses. The bait uses of fenitrothion
would result in minimal inhalation exposure and no dermal exposure because they are
formulated in metal containers.
(6) Post Application Worker Exposures and Assumptions
Additional handler exposure studies are required at this time.
There are no exposure data to support powered personal sprayer
and liquid spreader application. Mixer/loader/applicator low and
high-pressure handwand and knapsack/backpack data (Guideline
231, 232, 233 and 234) are required to support these uses. The
following Table summarizes handler data that are required to
support fenitrothion reregistration.
20
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Mixer/loader/applicator data requirements for fenitrothion
Guideline
Series
231
232
233
234
Study Category (Title)
Estimation of Dermal
Exposure at Outdoor
Sites
Estimation of
Inhalation Exposure at
Outdoor Sites
Estimation of Dermal
Exposure at Indoor
Sites
Estimation of
Inhalation Exposure at
Indoor Sites
Required Scenarios
(1) Low-pressure handwand applications
to ornamentals
(2) Knapsack/Backpack application to
ornamentals
(3) High-pressure handwand application
to ornamentals
(1) Low-pressure Handwand
applications to ornamentals
(2) Knapsack/Backpack application to
ornamentals
3) High-pressure handwand application
to ornamentals
(1) Indoor application to ornamentals
(1) Indoor application to ornamentals
Additional post-application exposure studies are required at this time. The following Table
summarizes post-application data that are required to support fenitrothion reregistration.
Summary Post-Application Monitoring Requirements
Guideline
Series
132-la
133-3
133-4
Study Category
(Title)
Dissipation of
Dislodgeable Foliar
Residues
Measurement of
Dermal Exposure
Measurement of
Inhalation Exposure
Required Scenarios
(1) Ornamentals, nursery
stock/greenhouses
(1) Post-application exposure during
ornamental propagation activities
(1) Post-application exposure during
ornamental propagation activities
21
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3. Risk Assessment
a. Dietary
Toxicological Endpoints
Chronic exposure calculated in this analysis was
compared to a Reference Dose (RfD) of 0.0013 mg/kg body
weight/day, based on a No-Observed-Effect-Level (NOEL)
of 0.125 mg/kg bwt/day and an Uncertainty Factor of 100.
The NOEL was taken from a one-year feeding study in dogs
which demonstrated plasma cholinesterase inhibition and
lymph node hemorrhaging.
Residue parameters
There are no food uses of fenitrothion currently
registered which are subject to reregistration. A food
additive regulation exists in 40 CFR 185.2200(a) for
residues of fenitrothion and two of its metabolites in wheat
gluten resulting from postharvest application of the
insecticide to stored wheat in Australia.
The HED Metabolism Committee has concluded that
only fenitrothion per se needs to be regulated in wheat
gluten; the Residue Chemistry Chapter recommends that the
food additive regulation expression for residues of
fenitrothion be amended to specify fenitrothion only at 15
ppm. In the DRES analysis, the existing food additive
regulation of 30 ppm was entered as the food additive
regulation and the recommended tolerance of 15 ppm was
entered as an anticipated residue.
Dietary Risk
The Dietary Risk Evaluation System (DRES) does not
specifically have a consumption estimate for "wheat gluten."
The closest food category in DRES is "wheat flour." In an
effort to get a more realistic consumption estimate for wheat
gluten, the Agency estimated the amount of wheat gluten
imported from Australia. According to USDA, all wheat
gluten consumed in the United States is imported; around
40,000 metric tons of wheat gluten are imported into this
22
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country annually, with about 40 percent of this coming from
Australia. Using these estimates, assuming that the U.S.
population is approximately 255,462,000 (1992 Census),
and assuming the average body weight of the U.S.
population to be 58.9 kg (the mean body weight of
respondents in the 1977-78 Nationwide Food Consumption
Survey, from which DRES consumption estimates are
derived), a consumption estimate for Australian wheat
gluten of 0.002913 g/kg bwt/day was calculated. By
comparing this consumption estimate to that for flour
(1.2572489 g/kg bwt/day), a conversion factor of 0.23,
reflecting gluten consumption as a percentage of wheat flour
consumption, was derived and used in the DRES analysis.
Using the derived wheat gluten consumption estimate and
the recommended residue of 15 ppm, exposure to the
overall U.S. population was estimated at 0.000043 mg/kg
bwt/day, which represents 3% of the RfD. If one assumes
that wheat gluten is consumed by children at the same ratio
to the overall U.S. population's consumption that wheat
flour is, the estimated exposure for children 1 through 6 is
0.000097 mg/kg bwt/day or 8% of the RfD. If the existing
food additive regulation of 30 ppm is used, these exposure
and risk estimates are doubled (7% of the RfD for the
overall U.S. population, 15% of the RfD for children aged
1 through 6).
The acute neurotoxicity endpoint is appropriate for
dietary risk assessment. An acute dietary risk from
consumption of Australian gluten is unlikely because gluten
is mixed with flour.
b. Occupational and Residential
The toxicological endpoints of concern for occupational and
residential exposure to fenitrothion are dermal toxicity
(cholinesterase inhibition) resulting from intermediate (one week to
several months) exposures and inhalation toxicity (cholinesterase
inhibition) resulting from chronic exposure. To estimate MOEs for
intermediate exposures, a NOEL of 3 mg/kg/day was used based on
systemic toxicity from a 21-day dermal toxicity study. Because the
effects are from a dermal study, a dermal absorption of 100% is
assumed. To estimate MOEs for chronic exposures, a NOEL of
0.049 mg/kg/day was used based on the inhalation toxicity from a
23
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90-day inhalation study. An inhalation absorption of 100% is
assumed.
The calculations indicate that MOEs are less than 100 for: (1)
applicators when low-pressure handwands are used; and (2) for
mixer/loader/applicators when low-pressure or knapsack/backpack
equipment is used.
MOE estimates are listed in the following table for use scenarios
considered eligible for reregistration. These calculations include
proposed risk mitigation labeling.
Exposure Scenario
Short term and
Intermediate MOE
Dermal
Inhalation
Mixer/Loader Exposures
Open Mixing
Wettable Powders
Open Mixing
Liquids
140
448
1303
13,720
Applicator Exposures
Low Pressure Handwand
Application
High Pressure
Handwand Application
42
129
26
60,978
Mixer/Loader/Applicator Exposures
Mixing and Application
with Low Pressure
Handwands
Knapsack/
Backpack Application
Mixing/ Application
High Pressure
Handwand
5
65
305
521
340
279
It should be assumed that these MOEs represent a conservative
estimate. Because the unit exposure data were of poor quality and
the number of replicates were insufficient, the MOE estimates
provided may either understate or overstate risk to handlers from
24
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the ornamental uses. Chemical specific data are needed to
adequately estimate potential risk.
Risk from Post-Application Exposure/Residential Use
Due to the lack of exposure data, the Agency is unable to
estimate the post-application risk to workers following applications
to ornamentals outdoor or in greenhouses. Minimal inhalation and
no dermal exposure would result from the ant and roach bait uses,
therefore the risk from these uses are believed to be negligible.
The registrant requested voluntary cancellation of both malaria
control product registrations. The Agency had calculated low
MOEs for this use and it is not eligible for reregistration.
C. Environmental Assessment
1. Environmental Fate
All environmental fate guidelines needed to support terrestrial
nonfood, greenhouse nonfood, and domestic outdoor use sites are fulfilled at
this time, with the exception of the terrestrial field dissipation (164-1) study.
It is unlikely that the additional information provided by this guideline will
change the overall qualitative assessment for fenitrothion. The data would
have a bearing on any quantitative assessment of fenitrothion exposure.
The registrant has proposed major risk mitigating label
modifications, i.e., deleting Christmas tree use, allowing only spot
ornamental treatments rather than broadcast applications, reducing the
application rate on a per acre basis (0.3 Ibs ai/acre), limiting the number of
fenitrothion applications to three per year, and increasing the minimum
interval between applications to one month. If these proposed label changes
are made to all fenitrothion end-use products, the terrestrial field dissipation
study will not be required.
a. Environmental Chemistry, Fate and Transport
(1) Hydrolysis
Phenyl-labeled [14C]-fenitrothion degraded with half-lives
of 191 to 200 days in sterile buffered (pH 5-9) solutions.
The major degradate in Ph 5 and pH 7 buffered solutions
was demethylated fenitrothion. The major degradate in pH
25
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9 buffered solution was 3-methyl-4-nitrophenol. (MRIDs
40717901, 00090500)
(2) Photodegradation in water
Phenyl-labelled [14C]-fenitrothion degraded with a half-
life of 4-7 days. The major non-volatile degradate was 0,0-
dimethyl 0-(3-carboxyl-4-nitro-phenyl) phosphorothioate
which reached a maximum of 12.4% of the applied
radioactivity by 14 to 30 days after application. (MRIDs
40717902, 00159953, 00159952, 00088273, 00061839)
(3) Photodegradation in soil
Fenitrothion degraded with a half-life of 85 days when
applied to a sandy loam soil and exposed to a light source
(simulating sunlight). Seven degradates were identified,
each reaching a maximum of less than or equal to 4.7% of
applied radioactivity. (MRIDs 41346901, 00088273,
40865501)
(4) Photodegradation in air
This data requirement is waived because fenitrothion has
a very low vapor pressure, approximately 5 x 106 mm Hg
at20EC. (MRID 41148901)
(5) Aerobic soil metabolism
Fenitrothion degrades with a half-life of approximately
2 days in sandy loam soil. The major nonvolatile degradate
was 3-methyl-4-nitrophenol which reached a maximum
concentration of 20% of the applied radioactivity at 1 to 3
days. Other degradates identified were fenitrooxon,
desmethylfenitrooxon, and 3-methyl-4-nitroanisole each
reaching a maximum of less than or equal to 0.9% of
applied by 21 days posttreatment. 14C02 was the major
volatile degradate which reached a reported maximum
concen-tration of 71.1% of the applied radioactivity 365
days after application. (MRIDs 41295101, 00061842,
00159950, 00126945)
26
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(6) Anaerobic aquatic metabolism
The anaerobic aquatic half-life for fenitrothion is 0.82
days. Less than 1.0% (approximately 0.01 ppm) of applied
radioactivity was identified as parent material 1 month after
application. During the testing period, cumulative volatiles
reached 1.1% of applied, 50% of which was 14C02. In
addition, non-extractable 14C-residues increased to 73.9%
of recovered radioactivity by day 365 posttreatment of
which approximately 85% was fractionated into fulvic and
humic acid. Three extractable degradates were identified,
3-methyl-4-nitrophenol (15% of applied at day 2 after
application), aminofenitrothion (13% of applied at day 3
post-treatment), and acetylaminofenitrothion (13% of ap-
plied at day 3 post treatment) during the testing period. One
minor extractable degradate was identified, formylaminofen-
itrothion (maximum 4.9% of applied at day 7 posttreat-
ment). By day 273, all degradates were less than 1.3% of
applied radioactivity (MRIDs 41615701, 00159950,
00159949, 00061842)
(7) Leaching/adsorption/desorption
Aged: Aged fenitrothion residues were reported to be
found mainly in the top 5 inches of soil columns. An
average 3.8% of the recovered fenitrothion was volatilized
from the soil columns during the testing period. The major
nonvolatile degradate, 3-methyl-4-nitrophenol, and parent
fenitrothion were not detected in the leachate from the
columns during leaching.
Unaged: In sand, sandy loam, silty clay loam, and silty
clay soil, fenitrothion was slightly mobile to immobile
(Kads=4.9 to 32). In addition, in pond sediment fenitrothion
appears immobile (Kads = 830), as well. Desorption values
were similar (Kdes values = 6.8 to 42; for pond sediment
approximately 550). Adsorption/desorption values were
strongly correlated with the organic matter of the soils.
(MRIDs 40420502, 00159956, 00159951, 00126947,
00061842)
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(8) Soil Dissipation Studies (164-1)
Fenitrothion and 3-methyl-4-nitrophenol (3M4NP)
indirectly applied to soil 0 to 3 inches depth had reported
half-lives of 18 and 25 days, respectively, in Evesboro
loamy sand soil. In another study fenitrothion and 3-
methyl-4-nitrophenol (3M4NP) indirectly applied to soil 0
to 3 inches depth had reported half-lives of 3 and 12 days,
respectively. Because fenitrooxon was not present at
discernible levels except in sufficient soil samples, no half-
live was calculated for fenitrooxon. Fenitrooxon was be-
lieved to be a transient compound that converts to 3M4NP.
Fenitrothion and the major degradate 3M4NP are expected
to be slightly persistent and relatively immobile in soil, i.e.,
leaching of fenitrothion and/or it's major degradates is not
expected. (MRID 41646601)
Another terrestrial field dissipation study is of uncertain
value for several reasons the most important being a poor
mass balance, i.e., recovery of the applied dose was
< 50%. However, it is unlikely that additional information
will significantly affect the overall qualitative assessment.
(9) Bioaccumulation in fish
Fenitrothion appears to accumulate rapidly but at low
concentrations. Maximum BCFs (bioconcentration factor)
of 33X, 341X, and 129X for edible, nonedible, and whole
fish tissues, respectively, were reached by Day 3
postexposure. Depuration was fairly rapid with 93.2 to
95% depuration of accumulated radioactive residues by Day
3 of depuration. Other degradates in edible and non-edible
tissues at concentrations equal to or greater than 0.05 ppm
identified were a sulfate conjugate of 3-methyl-4-
acetylaminophenol, a sulfate conjugate of 3-methyl-4-
nitrophenol, a hydroxymethyl derivative of oxidized
desmethylfenitrothion, and glucuronide conjugates of 3-
methyl-4-acetylaminophenol and 3-hydroxymethyl-4-
nitrophenol. (MRIDs 41654001, 40847001)
(10) Volatility (lab)
The volatility of fenitrothion from a sandy loam soil at
50% and 75% moisture capacity was evaluated for 21 days
28
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at 25 plus or minus 1°C. Approximately 88% of applied
radioactivity was recovered as extractable fenitrothion
residues. From 0.13 to 2.2% of applied radioactivity was
recovered as volatile material during the testing period, and
approximately 6% of applied radioactivity was recovered as
soil bound residues. Two volatiles, parent fenitrothion and
3M4NP (3-methyl-4-nitrophenol), were identified which
reached maximum concentrations of 89.5% and 4.2% of
volatile material (approximately 2% of applied
radioactivity), respectively. A minor peak (less than 2% of
volatile material) was discernible in Day 21 and Day 14 and
Day 21 of the 50% and 75% moisture content soil samples
which co-chromatographed with fenitrooxon. There was an
unknown volatile which reached a maximum concentration
of 0.8% of applied radioactivity (10.3% of volatile materi-
al) . The authors reported that the rate of volatilization
appeared to be dependent on soil moisture. Furthermore,
the vapor pressure of fenitrothion was observed to decline
for the soil at both moisture contents treated. The average
vapor pressure was 5.75 x 106 mm Hg at Day 1 and
dropped to 3.36 x 106 mm Hg at Day 21 for the 75%
moisture content soil samples. The average vapor pressure
was 5.25 x 106 mm Hg and dropped to 2.21 x 10 6 mm Hg
after 21 days for the 50% moisture content soil samples.
(MRID 41148902)
b. Environmental Fate Assessment
This environmental fate assessment is based on
acceptable laboratory data and supplemental field data.
These laboratory data indicate that the major routes of
dissipation are biotic microbial mediated processes to C02
and abiotic aquatic photolysis. The half life for aerobic soil
metabolism is 2.1 days, 0.82 days for anaerobic aquatic
metabolism, and 4-7 days for abiotic aquatic photolysis in
sterile pH 5-9 solutions. Furthermore, fenitrothion appears
to be non-mobile when applied to silty clay loam, silty
clay, and sandy loam soils (Kads = 13.0-32.0). Even though
the field data are supplemental, fenitrothion in different
formulations appears to dissipate fairly rapidly, with a half
life of 3 to 25 days and does not appear to be mobile. It is
found in mainly the top 6" of soil. Therefore, based on the
present data base, fenitrothion is expected to be slightly
persistent and relatively non-mobile in the soil environment.
29
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C02 was the major degradate for aerobic soil metabolism
and photolysis. For aerobic soil metabolism, C02 was
27.5% of applied at Day 5 posttreatment, and for
photolysis, was 41.2 to 42.0% of applied for
photodegradation in water and 4.3% of applied for
photodegradation on soil by Day 30 posttreatment. During
the anaerobic aquatic testing period cumulative volatiles
reached 1.1% of applied of which 50% was determined to
be 14C02. Major nonvolatile degradates for aerobic soil
metabolism, anaerobic aquatic metabolism, and photolysis
appear to be 3-methyl-4-nitro-phenol (approximately 1 to
22% of applied), aminofenitrothion (approximately 13% of
applied), acetyl-aminofenitrothion (approximately 13% of
applied), formylaminofenitrothion (4.9% of applied), 0,0-
dimethyl o-(3-carboxy-4-nitrophenyl)phosphorothionte
(12.4% of applied), fenitrooxon (less than or equal to 4.3%
of applied), demethylate fenitrothion (approximately 1% of
applied), and desmethylfenitrooxon (less than or equal to
4.3% of applied). Other degradates identified [0,0-
dimethyl o-(3-methyl-4-nitrophenyl)phosphorothioate-3-
methyl-4-nitrophenol, o-methyl (5-methyl o-(3-methyl-4-
nitrophenyl)phen-phorothioate, o-methyl o-hydrogen o-(3-
methyl-4-nitro-phenyl) phosphate, o,o-dimethyl o-(3-
carboxy-4-nitrophenyl)phosphate, 5-methylfenitrothion, and
carboxyfenitrooxon] were each present at concentrations of
less than or equal to 2%. Even though fenitrothion does
dissipate fairly rapidly when exposed to aerobic conditions
and a light source, it hydrolyses slowly in sterile aqueous
solutions with a hydrolysis half life of 100 to 200 days in
pH 5-9 solutions. The major degradates reported
discernible in pH 5 and pH 9 solutions were demethylated
fenitrothion at 10.3% of applied and 3-methyl-4-nitrophenol
at 1.7% of applied. The major degradate in the pH 9
solution was 3-methyl-4-nitrophenol at 15.1% of the
applied. Demethylated fenitrothion comprised up to 5.6%
of applied.
Persistence of the individual metabolites has not been
verified. However, it does appear in laboratory and field
data that they degrade fairly rapidly to C02, as well. In
addition, laboratory and field data indicate that fenitrothion
degradates are relatively non-mobile. Although all soil
segments treated with aged fenitrothion contained
30
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radioactive residues, the majority, 68.2-69.2% of the
applied, of the [14C]residues in the soil columns were
concentrated in the surface 1-inch layer. The 1 to 2 inch
soil segment contained less than or equal to 2.6 to 5.4% of
the applied radioactivity. Other soil segments contained less
than or equal to 3.3% of the applied radioactivity.
Fenitrothion was not detected in leachate from the columns.
Extensive extraction and thin layer chromatography (TLC)
analysis of the leachate resulted in the isolation of thirteen
distinct areas of radioactivity plus the origin. None of these
areas contained less than 0.002 ppm of radioactivity. The
field data indicate that fenitrothion residues do not leach
below the 0 to 12 inches soil depth.
Bioaccumulation data indicate that fenitrothion
accumulated in fish with low maximum BCFs, 33X, 34IX,
129X for edible, nonedible, and whole fish tissue,
respectively, and were reached in bluegill by Day 3 of
exposure. In addition, depuration was reported to be 93.2
to 95% of the accumulated radioactive residues by Day 3 of
depuration.
2. Ecological Effects
a. Ecological Effects Data
The ecotoxicological data base is adequate to characterize the
toxicity of fenitrothion to nontarget terrestrial and aquatic
organisms when used on terrestrial food, feed and nonfood sites.
Wildlife toxicology data (71-1) for 3-methyl-4-nitrophenol, the
major fenitrothion degradate, are now required. It is unlikely that
the additional information provided by this study will change the
overall qualitative assessment for fenitrothion. The data would
have a bearing on any quantitative assessment of fenitrothion
exposure.
(1) Terrestrial Data
In order to establish the toxicity of fenitrothion to birds,
the following tests are required using the technical grade
material: one avian single-dose oral (LD50) study on one
species (preferably mallard or bobwhite quail); two subacute
dietary studies (LC50) on one species of waterfowl
(preferably the mallard duck) and one species of upland
31
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game bird (preferably bobwhite quail or ring-necked
pheasant).
(a) Avian Acute Toxicity
Avian Acute Oral Toxicity Findings
Species
Bobwhite quail *
Ring-necked
pheasant
% Test Material
TGAI
TGAI
LC50/LU50
LC50 =157 ppm
LD50 = 34.5 mg/kg
Conclusions
highly toxic
* - Most sensitive species is the bobwhite quail; mallard duck LC50 = 2482 ppm
These results indicate that fenitrothion is highly toxic to birds. (MRIDs
00022923, 00126885)
(b) Avian Chronic
Avian reproduction studies are required when birds may be exposed repeatedly
or continuously through persistence, bioaccumulation, or multiple applications, or
if mammalian reproduction tests indicate reproductive hazard. Present product
labeling of fenitrothion allows several applications of the end-use product per
growing season.
Avian Reproduction Findings
Species
Bobwhite Quail
Reproductive Impairment
Reduced egg production =17.0 ppm
(LOEL) NOEL = 13.0 ppm
Chronic effects (reduced egg production) were observed during the avian
reproduction study with bobwhite quail at the 17.0 ppm concentration level.
The No-Observed Effect Level (NOEL) was determined to be 13.0 ppm.
(MRID 41958401).
(c) Toxicity to Nontarget Mammals
The minimum data required to establish the toxicity of fenitrothion to mammals is an acute
oral toxicity study.
32
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Mammalian Acute Oral Toxicity Findings
Species
Rats
Rats
% Test Material
97.2%
77%
LD5n
330 mg/kg
355 mg/kg
Conclusions
moderately toxic
The available mammalian data indicate that fenitrothion is moderately toxic to small mammals
on an acute basis. (MRIDs 232483, 246664, 002739)
(2) Aquatic Data
(a) 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 the rainbow trout), and the other should use a warm
water species (preferably the bluegill sunfish).
Freshwater Fish Acute Oral Toxicity Findings
Species
Rainbow trout
Bluegill sunfish
Brook trout
Cutthroat trout
% Test Material
95
95
95
technical
LC5n (ppb)
2400
3900
1720
2880
Conclusions
moderately toxic
The results of the four 96-hour acute toxicity studies indicate that
fenitrothion is moderately toxic to both cold and warm water fish. (MRIDs
40094602, 00125909, 00120401)
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(b) Freshwater Fish Chronic Effects
Data from a fish early-life stage test is required if an active ingredient is
persistent in water, or chronic exposure is otherwise expected.
Freshwater Fish Early-life Stage Findings
Species
Rainbow trout
% Test Material (TGAI)
94.5
NOEL/MATC/LOEL (ppb)
46/64/88
The LOEL is based upon effects on the weight and length of rainbow
trout. The guideline requirement for fish chronic toxicity testing on the
technical material has been satisfied. (MRID 40891201)
(c) Freshwater Invertebrate Toxicity
The minimum testing required to assess the hazard of a pesticide is a
freshwater aquatic invertebrate toxicity test, preferably using first instar
Daphnia magna or early instar amphipods, stoneflies, mayflies, or midges.
Freshwater Invertebrate Toxicity Findings
Species
Daphnia magna
Gammarus
Pater onarcella
Daphnia magna
% Test Material
(TGAI)
95
95
95
76.8
EC50/LC50 (ppb)
11
4.3
5.1
2.3
Conclusions
very highly toxic
There is sufficient information to characterize fenitrothion as very highly
toxic to aquatic invertebrates. The guideline requirement is satisfied. (MRIDs
40094602, 00120401, 40620901)
(d) Freshwater Aquatic Invertebrate Chronic Effects
Data from a freshwater aquatic invertebrate life-cycle study is
required if an active ingredient is persistent in water.
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Freshwater Aquatic Invertebrate Life-cycle Findings
Species
Daphnia magna
% Test Material (TGAI)
94.5
NOEL/MATC/LOEL
(ppb)
0.087/0.19/0.23
The 21 day LOEL is based upon adult daphnid survival. (MRID
40891101)
(e) Estuarine/Marine Toxicity
Acute toxicity testing with estuarine and marine organisms is required when an
end-use product is intended for direct application to the marine/estuarine
environment or is expected to reach this environment in significant concentrations.
The terrestrial nonfood use of fenitrothion may result in exposure to the estuarine
environment.
The requirements under this category include a 96-hour LC50 for an estuarine
fish, a 96-hour LC50 for shrimp, and either a 48-hour embryo-larvae study or a 96-
hour shell deposition study with oysters.
Estuarine/Marine Acute Toxicity Findings
Species
Eastern oyster
embryo larvae
Pink Shrimp
Sheepshead minnow
% Test Material
(TGAI)
75
75
75
EC50/LC50 (ppb)
450
1.5
>1000
Conclusions
moderately to very
highly toxic
There is sufficient information to characterize fenitrothion as moderately to very
highly toxic to estuarine organisms. (MRID 40228401)
(3) Non-Target Insects Data
The minimum data required to establish the acute toxicity to honey bees is an
acute contact LD50 study with the technical material.
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Nontarget Insect Acute Contact Toxicity Findings
Species
Honey bee
Honey bee
Test
Material
TGAI
TGAI
LDso
0.02 ug/bee
0.38 ug/bee
Conclusions
highly toxic
There is sufficient information to characterize fenitrothion as highly toxic to
bees. (MRIDs 05001991, 00036935)
(4) Non-Target Plants Data
Plant testing was not required for this insecticide.
b. Ecological Effects Risk Assessment
This section consists of numerous risk assessments each covering a different
combination of endpoint and exposure scenarios. Each risk assessment includes a
risk quotient which combines the toxicity and exposure information. For each risk
quotient there is an established value above which the risk is considered to be at a
high level of concern (LOG). In addition to these high risk values, restricted use
is considered when the risk quotient exceeds the 0.1 for acute aquatic risk or 0.2
for acute avian risk. The generic risk quotients and their respective LOC's for
each risk assessment are provided in the following table. Note that the same risk
quotients are used for nonendangered and endangered species, but the acute LOG
is lower for endangered species.
Endpoint/
Scenario
Mammalian
acute
Mammalian
chronic
Avian acute
Risk Quotient
EEC/LC50
EEC/LEL
FF,r,/T r.™
Non-endangered
LOG
0.5
1.0
05
Endangered
LOG
0.1
1.0
01
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Endpoint/
Scenario
Avian
chronic
Aquatic
acute
Aquatic
Chronic
Non-target
insects/
plants
Risk Quotient
EEC/LEL
EEC/LC50
EEC/LEL
Not
quantified
Non-endangered
LOG
1.0
0.5
1.0
N/A
Endangered
LOG
1.0
0.05
1.0
N/A
1. Non-Endangered Terrestrial Organisms
Avian Species (Acute)
Fenitrothion labels do not specify the amount of active ingredient (ai) that may be
applied per acre during each application. The chemical may be applied once per week.
For this risk assessment, the Agency assumes that 100 gallons of spray solution may be
applied per acre. The 76.8% ai formulation containing 8 Ibs of fenitrothion per gallon
may be applied in concentrations of 3 pts. of product per 100 gallons. Therefore,
fenitrothion may be applied at 3 Ibs ai/acre (8 Ibs/gal x 1 gal/8 pt x 3 pt/100 gal x 100
gal/acre). The Tables below provide the risk quotients for terrestrial organisms.
The weight of a ring-necked pheasant is estimated to be 1.135 kg. The number of
LD50s/square foot is calculated as follows:
3.0 Ibs ai/acre x 454,000 mg/43,560 sq ft = 0.8 LD50s/sq ft
3.5 mg/kg x 1.135 kg
A ring-necked pheasant can consume up to 9.2% of its body weight per day. The
number of LD50s/day resulting from exposure to residues on short grass, insects, and
seeds are calculated as follows:
3.0 Ibs ai/acre x 240x0.092 =1.9 LD50s/day (grass eaters)
34.5 mg/kg
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3.0 Ibsai/acrex 58x0.092 =0.5 LD50s/day (insect eaters)
34.5 mg/kg
3.0 Ibsai/acrex 12x0.092 = 0.1 LD50s/day (seed eaters)
34.5 mg/kg
The maximum residue levels on short grass following a 3 Ibs ai/acre application is 3.0
x 240 ppm = 720 ppm (Kenaga 1972). The avian dietary EEC/LC50 risk quotients on
short grass, insects, and seeds are calculated as follows:
3.0 x 240 ppm =4.6 (grass eaters)
157 ppm
3.0 x 58 ppm =1.1 (insect eaters)
157 ppm
3.0 x 12 ppm =0.2 (seed eaters)
157 ppm
Based upon maximum exposures, high acute risk is expected for birds consuming grass
and insects following a single 3.0 Ib ai/acre application. Although the acute risk to seed
eating birds is less, the risk still exceeds the restricted use Level of Concern (LOG) of
0.2. All of the risk quotients exceed the endangered species LOG of 0.1 See the Table
below.
Acute Risk Quotients for Birds (Single Application)
Maximum
Application
Rate
3.0
Ibs/ai/acre
Risk
Quotient -
LD50/ft2 *
0.8
Risk
Quotient -
LD50/day *
1.9
(grass)
0.5
(insects)
0.1
(seeds)
Risk Quotient
(EEC/LC50)
**
4.6
(grass)
1.1
(insects)
0.2
(seeds)
* The bird LD50 value is 34.5 mg/kg
** The bird LC50 value is 157 ppm
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To get below the high risk LOG, the application rate would need to be reduced to 0.3
Ibs ai/acre for non-endangered species and 0.06 Ibs ai/acre for endangered species. The
registrant has proposed lowering the application rate to 0.3 Ibs ai/acre, see Section IV.
Avian Species (Chronic)
Based upon maximum exposure values, high chronic risk to seed, insect, and grass
eating birds will occur when exposed to a single as well as multiple applications of
fenitrothion at 3.0 Ibs ai/acre. The registrant has proposed numerous label
modifications including a lower use rate, a restriction on the maximum number of
applications per year and a retreatment interval increased from one week to one month.
See Section IV for a detailed discussion.
Chronic Risk Quotient (EEC/NOEL) for Birds
Number of
3.0 Ib/ai/A
Applications
per year
1
53
Risk Quotient
EEC/NOEL1
(seeds)
2.8
(36 ppm)
13.8
(180 ppm)
Risk Quotient
EEC/NOEL1
(grass)
55.4
(720 ppm)
277
(3,600 ppm)
LOG
HR2 >1
HR >1
1 The reproductive NOEL is 13 ppm.
2 HR = High Risk
3 Current labels do not limit the total number of applications/year. Therefore,
it is assumed that five applications may be applied per season with no
degradation.
Mammals
The following table provides risk quotients (EEC/one day LC50) for a single 3 Ib
ai/acre application of fenitrothion (broadcast):
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Acute Risk Quotients for Mammals (Single application)
Species
(One day
LC50)
Meadow vole
(540 ppm)
Least shrew
(300 ppm)
Old field
mouse
(2, 043 ppm)
Expected
Food
(EEC ppm)
Grass
(720)
Insects
(174)
Seeds
(36)
Risk quotient
EEC/one day
LC50
1.3
0.6
0.02
LOG
HR1 > 0.5
RU2 > 0.2
ES3 > 0.1
HR1 > 0.5
RU2 > 0.2
ES3 > 0.1
HR1 > 0.5
RU2 > 0.2
ES3 > 0.1
1 - HR = High Risk
2 - RU = Restricted Use
3 - ES = Endangered Species
These risk quotients exceed the endangered species (ES) LOG of 0.1, the restricted use
(RU) LOG of 0.2 and the high risk (HR) LOG of 0.5. Risk quotients are calculated based
on the LD50 value for laboratory rats (330 mg/kg). The percentage of body weight mammals
consume per day is estimated to be 16, 61, and 110% for the old field mouse, meadow vole,
and least shrew, respectfully (Davis and Golly 1963). Current fenitrothion labels do not
restrict the number of applications that may be applied per year. Risk quotients based upon
multiple applications may be substantially greater than those shown in the table above.
2. Non-Endangered Aquatic Organisms
Freshwater (Acute)
Since the labels do not specify the amount of fenitrothion that may be applied per unit area,
it is assumed that 100 gallons of spray solution may be applied per acre. The aquatic
EEC's for an unincorporated ground application are calculated as follows:
3 Ibs ai/acre x 0.02 (% runoff) x 10 acres x 61 ppb = 36.6 ppb
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The following table provides acute risk quotients for freshwater aquatic organisms. High
acute risk from a single application is expected for freshwater invertebrates. Acute risk
to fish is below all levels of concern for a single application. Multiple applications would
result in higher risks.
Acute Risk Quotients for Freshwater Aquatic Organisms Following a Single 3.0 Ib
ai/acre Application
Species
Freshwater
fish
Freshwater
invertebrates
EEC for 6 ft
deep aquatic
habitat (ppb)
36.6
36.6
Risk Quotient
EEC/LC501
or
EEC/EC501
0.02
8.5
LOG
HR2 >0.5
RU3 >0.2
ES4 >0.1
HR2 >0.5
RU3 >0.2
ES4 >0.1
1 - LC50 is 1,720 ppb for freshwater fish and the EC50 is 4.3 ppb for freshwater
invertebrates.)
2- HR = High Risk
3 - RU = Restricted Use
4 - ES = Endangered Species
Freshwater (Chronic)
The labels do not specify the maximum number of applications of fenitrothion that may
be applied per year, however, the EEC is based upon a single application. The risk
quotient from a single application exceeds the endangered species and high risk levels of
concern for freshwater invertebrates. Chronic risk to freshwater fish from a single
application is below all levels of concern. For multiple applications, it is expected that the
risk would be higher. The following table provides chronic risk quotients for freshwater
aquatic organisms.
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Chronic Risk Quotients for Freshwater Aquatic Organisms Following a Single 3.0 Ib
ai/acre Application.
Species
Freshwater
fish
Freshwater
Invertebrates
Chronic
Geometric
Mean MATC
(ppb)
64
0.19
EEC for 6 ft
deep aquatic
habitat (ppb)
36.6
36.6
Risk Quotient
(EEC/MATC)
0.57
229
Estuarine/Marine
The following table provides acute risk quotients for marine/estuarine organisms. The
acute risk quotient, from a single application, exceeds the endangered species and high risk
levels of concern for marine/estuarine invertebrates (arthropods). Acute risks to fish and
mollusc from a single application are below all levels of concern. For multiple applications
the risk may be greater.
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Acute Risk Quotients for Marine/Estuarine Organisms
Species
Marine/estuarine
fish
Marine/estuarine
invertebrate
Marine/
estuarine mollusc
LC50/
EC50
(ppb)
1,000
1.5
450
EEC for 6 ft
deep aquatic
habitat
36.6
36.6
36.6
Risk
Quotient
EEC/LC50
0.04
24.4
0.08
3. Effects on Beneficial Insects:
The data indicates that fenitrothion is highly toxic to honey bees. The acute contact LD50
value is 0.02 ug/bee. Honey bees that are exposed to this chemical may be adversely effected.
4. Endangered Species
As described in the above risk assessment sections, endangered species LOCs are exceeded
for acute effects to aquatic invertebrates and in some instances for acute effects to birds and
wild mammals. Endangered species LOCs are also exceeded for chronic effects to birds and
aquatic invertebrates.
Limitations on the use of fenitrothion may be required to protect endangered and threatened
species. However, these limitations have not yet been defined (and may be formulation
specific). The Agency anticipates that consultation with the Fish and Wildlife Service will be
conducted in accordance with the species-based priority approach described in the program.
Following the completion of the consultation registrants will be informed of any required label
modifications that are necessary. Such modifications would most likely consist of generic label
statements referring pesticide users to the limitations contained within county bulletins.
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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 fenitrothion active ingredients. The Agency made its reregistration
eligibility determination based upon chemical specific data required for reregistration, the
current guidelines for conducting acceptable studies to generate such data and the data
identified in Appendix B. In addition, the Agency made extensive use of the Pesticide
Handlers Exposure Database (PHED) for occupational exposure estimates.
Appendix B identifies the generic data requirements that the Agency reviewed as part of its
determination of reregistration eligibility of fenitrothion, and lists the submitted studies that
the Agency found acceptable. It also identifies unacceptable studies and the specific studies
required for fenitrothion reregistration.
1. Eligibility Decision
The Agency has determined that fenitrothion uses as currently registered pose adverse
effects to humans, aquatic organisms and wildlife. The technical registrant, Sumitomo
Chemical Company, has submitted a draft label for Sumithion 8E significantly reducing
fenitrothion use on ornamentals. These proposed label changes have mitigated human
health and ecological impact concerns making the high-pressure handwand treatment of
ornamentals use eligible for reregistration. This eligibility determination for reregistration
is contingent upon all ornamental end-use product labels (there are three products
registered for use on ornamentals) being revised as proposed.
On February 28, 1995 the registrant requested voluntary cancellation of the mosquito
(malaria) control uses of fenitrothion.
The Agency defers making a regulatory decision on both the low-pressure handwand and
knapsack/backpack methods of application until chemical-specific worker exposure studies
are submitted. Uncertainties in the existing worker exposure database do not allow the
Agency to determine, with confidence, the appropriate MOEs for these exposure scenarios.
However, the Agency believes it is in the public's best interest to implement the human
health and ecological effect exposure/risk mitigation measures negotiated with the registrant
at this time. Therefore, the Agency has decided not to delay issuing the fenitrothion RED
until these studies are submitted and reviewed. The Agency is requiring the registrant to
submit the worker exposure studies on an accelerated schedule, i.e., one year from
issuance of this document. Details concerning the required label changes can be found in
Section V, Actions Required by Registrants. When the chemical specific exposure data
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required by this RED are received, the Agency will make a regulatory decision regarding
the reregistration eligibility of the low-pressure handwand and knapsack/backpack methods
of application.
Fenitrothion has significant potential for causing adverse effects in aquatic organisms,
wildlife and the environment. Sumitomo Chemical Co. has proposed eliminating the
highest risk uses, and reducing the maximum application rate for all other uses. The
proposed label changes and the fact that this insecticide is not widely used (< 1% of U.S.
nursery acreage are treated annually) were given consideration in making the reregistration
decision for this insecticide. The high-pressure handwand treatment of ornamentals and
the two bait formulations are eligible for reregistration. Details are discussed in the
following section.
2. Eligible and Ineligible Uses
The registrant requested on February 28, 1995 that the malaria control uses of
fenitrothion be cancelled. These uses are not eligible for reregistration due to the low
MOEs for post-application exposure.
Treatment of ornamental plants involves a significant potential for causing adverse
effects to handlers, reentry workers, and nontarget terrestrial and aquatic organisms
including endangered species. The registrant has proposed revised labeling which deletes
high exposure/risk uses: Christmas tree use, basal bark treatment (drench treatment) and
limiting the treatment of shade trees to only those in nurseries. Consequently, Christmas
tree use, basal bark treatment and use on shade trees other than those in nurseries are not
eligible for reregistration. Additionally, the registrant has reduced the ornamental
treatment rate to 0.3125 Ibs ai/acre (30 gallons of Sumithion 8E, diluted at 0.5 ounces per
3 gallons, per acre (previously no limit was established); proposed limiting use to spot
treatment only rather than broadcast use (i.e., deleting overhead boomsprayers,
groundboom and liquid broadcast sprayer application from the label); proposed increasing
the retreatment interval from one week to one month; proposed restricting the maximum
number of applications per year to 3 (previously unspecified); and proposed labeling for
restricted use. The following uses are eligible for reregistration:
- Treatment of ornamental plants in nurseries and greenhouses only, with high-pressure
handwands provided the following restrictions are added to the label: restricted use
classification, maximum application rate of 0.3125 Ibs ai/acre, a maximum number of
applications of three per year is imposed, the minimum retreatment interval is increased
to once per month, use on Christmas trees is deleted, deletion of the drench treatment
for control of the southern pine bark beetle, and treatment of shade trees is limited to
those in nurseries and greenhouses.
- Ant and roach baits
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RESULTING RISK
ECOLOGICAL - The proposed mitigation measures reduce the risk quotients for
nontarget aquatic organisms by a factor of 10. Risk quotients are still exceeded for acute
(0.85) and chronic risk (22.9) to aquatic invertebrates. However, the chronic risk estimate
assumes no degradation between applications. Additionally, voluntary deletion of
broadcast methods of application will reduce the probability of fenitrothion runoff reaching
aquatic systems. The Agency has not recalculated terrestrial organism LOC's. Since
fenitrothion is applied to ornamentals to the point of dripping, the application rate within
specific areas that are treated is potentially much higher than 0.3 Ibs ai/acre. For instance,
if it is assumed that 10% of a nursery is treated at a rate of 0.3 Ibs ai/acre, then the
application rate within the treated area is 3.0 Ib ai/acre. The risk quotients for terrestrial
animals have not been reduced, however, the amount of acreage in which fenitrothion
poses a high risk has been significantly reduced. The Agency estimates that less than 3000
acres will be treated per year.
HUMAN HEALTH - The MOE's for high pressure handwand application are greater
than 100; however this is based on uncertain data and additional confirmatory data are
required.
B. Regulatory Position
The following is a summary of the regulatory positions and rationales for fenitrothion.
Where labeling revisions are imposed, specific language is set forth in Section V of this
document.
1. Tolerance Reassessment
There are no registered food uses for fenitrothion in the U.S. A food additive
regulation of 30 ppm is established for fenitrothion residues in or on imported wheat gluten
from Australia [40 CFR §185.2200(a)]. The food additive regulation is adequately
supported and poses no health risk. The food additive regulation expression for residue
of fenitrothion should be amended to specify fenitrothion only at 15 ppm.
2. Restricted Use Classification
All end-use products of fenitrothion labeled for outdoor use must have a restricted use
classification due to the acute and chronic toxicity of fenitrothion to non-target species.
3. Reference Dose Exceedance
There are no RfD exceedance issues associated with the registered uses of fenitrothion.
The Agency concluded that an RfD should be established based upon a NOEL of 0.125
mg/kg/day for systemic effects (histopathological changes in lymph nodes) and plasma
46
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cholinesterase inhibition observed at 0.25 mg/kg/day in a long-term feeding study in dogs.
An Uncertainty Factor (UF) of 100 was used to account for the inter-species extrapolation
and intra-species variability. On this basis the RfD was calculated to be 0.0013 mg/kg/day.
The Joint FAO/WHO Meeting On Pesticide Residues (JMPR) reports an ADI of 0.005
mg/kg bw (1988). Even if one assumes that residues are present at tolerance levels (an
unlikely assumption) exposure and risk estimates would be 7% for overall population and
15% of the RfD for children aged 1 through 6.
4. Risk Mitigation
The Agency has determined that registered uses of fenitrothion exceed levels of concern
for many uses. In response to these concerns mitigation measures are required (see section
V).
MALARIA CONTROL USES
The registrant has requested that malaria control uses of fenitrothion be cancelled. This
use is not eligible for reregistration.
5. Endangered Species Statement
The Agency has concerns about the exposure of threatened and endangered mammals,
birds and aquatic invertebrates to fenitrothion. Based on the conclusions discussed in the
preceding sections of this risk assessment, endangered species LOCs are exceeded in some
instances for acute effects to birds, wild animals and aquatic organisms. Endangered
species LOCs are also exceeded for chronic effects to birds and aquatic invertebrates.
Currently the Agency is developing a program ("The Endangered Species Protection
Program") to identify all pesticides whose use may cause adverse impacts on endangered
and threatened species and to implement mitigation measures that will address the adverse
impacts. The program would require use restrictions to protect endangered and threatened
species in the country. Consultations with the Fish and Wildlife Service may be necessary
to assess risks to newly listed species or from proposed new uses. In the future, the
Agency plans to publish in the Federal Register a description of the program and have
available enforceable county-specific bulletins. Because the Agency is taking this approach
for protecting endangered and threatened species, it is not imposing label modifications at
this time through the RED. Rather, any requirements for product use modification will
occur in the future under the Endangered Species Protection Program.
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6. Labeling Rationale
a. Occupational/Residential Labeling Rationale/Risk Mitigation
Compliance with Worker Protection
The 1992 Worker Protection Standard for Agricultural Pesticides (WPS) established
certain worker-protection requirements (personal protective equipment, restricted entry
intervals, etc.) to be specified on the label of all products that contain uses within the
scope of the WPS. Uses within the scope of the WPS include all commercial (non-
homeowner) and research uses on farms, forests, nurseries, and greenhouses to produce
agricultural plants (including food, feed, and fiber plants, trees, turf grass, flowers,
shrubs, ornamentals, and seedlings). Uses within scope include not only uses on plants,
but also uses on the soil or planting medium the plants are (or will be) grown in.
Registered uses of fenitrothion outside the scope of the WPS include the recently
registered bait products, one for roaches and another for ants.
Any product whose labeling reasonably permits use in the production of an
agricultural plant on any farm, forest, nursery, or greenhouse must comply with the
labeling requirements of PR Notice 93-7, "Labeling Revisions Required by the Worker
Protection Standard (WPS), and PR Notice 9311, "Supplemental Guidance for PR
Notice 93-7, which reflect the requirements of EPA's labeling regulations for worker
protection statements (40 CFR part 156, subpart K). These labeling revisions are
necessary to implement the Worker Protection Standard for Agricultural Pesticides (40
CFR part 170) and must be completed in accordance with, and within the deadlines
specified in, PR Notices 93-7 and 93-11. Unless otherwise specifically directed in this
RED, all statements required by PR Notices 93-7 and 93-11 are to be on the product
label exactly as instructed in those notices.
After April 21, 1994, except as otherwise provided in PR Notices 93-7 and 93-11,
all products within the scope of those notices must bear WPS PR Notice complying
labeling when they are distributed or sold by the primary registrant or any
supplementally registered distributor.
After October 23, 1995, except as otherwise provided in PR Notices 93-7 and 93-11,
all products within the scope of those notices must bear WPS PR Notice complying
labeling when they are distributed or sold by any person.
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Personal Protective Equipment (PPE) and Engineering Controls for Handlers (Mixer/
Loader/Applicators)
Occupational-Use Products (WPS and NonWPS Uses)
To EPA's knowledge, at this time some of the registered uses of fenitrothion are
within the scope of the Worker Protection Standard for Agricultural Pesticides (WPS)
and some are outside the scope of the WPS. The PPE requirements will pertain to both
the WPS and nonWPS uses by occupational handlers, since the potential exposure to
occupational handlers is similar for WPS and nonWPS uses.
For each occupational end-use product, PPE requirements for pesticide handlers will
be set during reregistration in one of two ways:
1. If EPA has no special concerns about the acute or other adverse effects of an active
ingredient, the PPE for pesticide handlers will be based on the acute toxicity of the end-
use product. For occupational-use products, PPE will be established using the process
described in PR Notice 93-7 or more recent EPA guidelines.
2. If EPA has special concerns about an active ingredient due to very high acute toxicity
or to certain other adverse effects, such as allergic effects or delayed effects (cancer,
developmental toxicity, reproductive effects, etc):
• In the RED for that active ingredient, EPA may establish minimum or "baseline"
handler PPE requirements that pertain to all or most occupational end-use products
containing that active ingredient.
• These minimum PPE requirements must be compared with the PPE that would be
designated on the basis of the acute toxicity of each end-use product.
• The more stringent choice for each type of PPE (i.e., bodywear, hand protection,
footwear, eyewear, etc.) must be placed on the label of the end-use product.
EPA has special concerns about the high acute toxicity (based on the
mixer/loader/applicator exposure assessment) of fenitrothion and is, therefore,
establishing baseline handler PPE requirements for any end-use product that contains
fenitrothion.
Handler PPE for Homeowner-Use Products
Only the two bait formulations of fenitrothion are intended primarily for
homeowner use.
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Post-application/Entry Restrictions
Restricted Entry Interval: Under the Worker Protection Standard (WPS), interim
restricted entry intervals (REI) for all uses within the scope of the WPS are established
based on the acute toxicity of the active ingredient. The toxicity categories of the active
ingredient for acute dermal toxicity, eye irritation potential, and skin irritation potential
are used to determine the interim WPS REI. If one or more of the three acute toxicity
effects are in toxicity category I, the interim WPS REI is established at 48 hours. If
none of the acute toxicity effects are in category I, but one or more of the three is
classified as category II, the interim WPS REI is established at 24 hours. If none of the
three acute toxicity effects are in category I or II, the interim WPS REI is established
at 12 hours. A 48-hour REI is increased to 72 hours when an organophosphate pesticide
is applied outdoors in arid areas. In addition, the WPS specifically retains two types
of REI's established by the Agency prior to the promulgation of the WPS: product-
specific REI's established on the basis of adequate data and interim REI's that are
longer than those that would be established under the WPS.
As an interim measure until adequate reentry data became available, the 1987
Fenitrothion Registration Standard established a reentry interval of 24 hours for
fenitrothion for all uses on agricultural plants, including ornamentals, Christmas trees,
and forestry trees. The 24-hour interim reentry interval (permits routine entry to
perform hand labor tasks if PPE is worn) was converted into a 24-hour interim
restricted entry interval (prohibits routine entry to perform hand labor tasks even if
wearing PPE) through modifications to the labeling specified in PR Notice 93-7, which
implemented the labeling requirements of the 1992 Worker Protection Standard for
Agricultural Pesticides (WPS).
Data needed to assess the risks to agricultural workers from post-application
exposures to fenitrothion are unavailable at this time, so the Agency is unable to
establish a permanent restricted entry interval. However, the Agency is concerned about
the post-application exposures of agricultural workers to fenitrothion, since the MOE's
for mixers, loaders, and applicators are low. Therefore, as an interim measure until
data are available to establish a permanent REI, the Agency will increase the interim
restricted entry interval to 48 hours for all uses of fenitrothion within the scope of the
WPS. In addition, the REI increases to 72 hours when fenitrothion is applied in outdoor
areas where the average rainfall is less than 25 inches per year.
Early Entry PPE The WPS establishes very specific restrictions on entry by workers
to areas that remain under a restricted-entry by workers if the entry involves contact
with treated surfaces. Among those restrictions are a prohibition of routine entry to
perform hand labor tasks and requirement that personal protective equipment be worn.
Personal protective equipment requirements for persons who must enter areas that
remain under a restricted-entry interval are based on the toxicity concerns about the
active ingredient. The requirements are set in one of two ways.
50
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1. If EPA has no special concerns about the acute or other adverse effects of an active
ingredient, it establishes the early-entry PPE requirements based on the acute
dermal toxicity, skin irritation potential, and eye irritation potential of the active
ingredient.
2. If EPA has special concerns about an active ingredient due to very high acute
toxicity or to certain other adverse effects, such as allergic effects or delayed
effects (cancer, developmental toxicity, reproductive effects, etc), it may establish
early-entry PPE requirements that are more stringent than would be established
otherwise.
Since EPA has special concerns about the high acute toxicity of fenitrothion, the
Agency is establishing PPE for dermal protection that is more stringent than the PPE
that would otherwise be established based on the acute toxicity of the active ingredient.
Since fenitrothion is classified as category II for eye irritation potential, protective
eyewear is required.
EPA believes that existing WPS protections are sufficient to mitigate inhalation
exposures to workers who enter treated areas outdoors or in a greenhouse after
fenitrothion has been applied. The Agency will not, therefore, establish a respirator
requirement for early-entry workers. The WPS prohibits anyone (except those who are
entering to perform a specific handler task and are wearing handler PPE, including the
respirator) from entering a treated area for the first four hours following application,
unless there will be no contact with pesticides, including pesticides on plants or in soil,
water, or air. The WPS places additional restrictions on entry during (and immediately
following) applications in enclosed areas when the applicator is required to wear a
respirator. These restrictions include:
• prohibiting anyone (except those who are participating in the application and who
are wearing the PPE required for applicators) from being in the entire enclosed
area (greenhouse) during the application.
• prohibiting anyone (except those who are entering to turn on ventilation equipment
and who are wearing the PPE required for applicators) from entering the
greenhouse after application is complete until specific ventilation criteria have been
met (e.g. 2 hours of mechanical ventilation, 4 hours of passive ventilation, etc.).
Occupational Use Products (Non-WPS Uses)
To EPA's knowledge, at this time some registered uses of fenitrothion are outside
the scope of the Worker Protection Standard for Agricultural Pesticides (WPS). The
Agency is establishing entry restrictions for all nonWPS occupational uses of
fenitrothion end-use products. For specific language refer to Section V of this
document.
51
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Homeowner Use Products (nonWPS Uses)
Only the ant and roach bait formulations are intended primarily for homeowner use.
Additional Labeling Requirements
The Agency is requiring additional labeling statements to be located on all end-use
products containing fenitrothion that are primarily for occupational use. For the
specific labeling statements, refer to Section V of this document.
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. In addition, the technical registrant must submit
a food additive petition changing the food additive regulation for fenitrothion as indicated in
Section IV.B.I, Tolerance Reassessment.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of fenitrothion for the above eligible
uses (ornamentals in nurseries and greenhouses only) has been reviewed and determined
to be substantially complete. However, additional confirmatory data are needed to fulfill
guideline requirements for the studies listed below:
71-1 Acute Oral LD50 for Bobwhite Quail with the major degradate: 3-methyl-
nitrophenol.
71-4 Chronic Toxicity to Birds with the major degradate: 3-methyl-nitrophenol.
(reserved pending results of 71-1 studies).
85-4-SS Six Month Ocular Toxicity Study in Dogs (Reserved)
164-1 Terrestrial Field Dissipation
The following data are required before the Agency can make a regulatory decision
regarding reregistration eligibility for the low-pressure handwand and knapsack/backpack
methods of application:
132-1 (a) Foliar Dissipation
133-3 Occupational Postapplication Dermal Exposure
133-4 Occupational Postapplication Inhalation 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
52
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These data are considered confirmatory for the high-pressure handwand method of
application.
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 a insecticide for the following uses(s): ornamental use in
greenhouses, nurseries and for use in ant and roach baits."
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 uses(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 uses(s).
Other current label precautions are still applicable and are required for product
reregistration if the product is to remain in compliance with FIFRA.
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.
53
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2. Labeling Requirements for End-Use Products
a. Restricted Use Classification
The Agency has determined that all fenitrothion products labeled for use outdoors must
be restricted-use based on acute, subchronic, and chronic effects to humans and/or non-
target species. The following statement must appear on all end-use products:
Restricted Use Pesticide
"This is a restricted use product due to toxicity to fish and aquatic organisms."
"For retail sale to and use only by certified applicators or persons under their direct
supervision and only for those uses covered by the certified applicator's certification."
The labels and labeling of all products must comply with EPA's current regulations and
requirements as specified in 40 CFR §156.10.
b. Changes Relating to Label Rates, Uses and Number of Applications
The following changes must be made to all fenitrothion end-use ornamental products.
1) Restricted use classification for all fenitrothion end-use products labeled for
outdoor use.
2) Deletion of Christmas tree farm and Southern Pine Bark Beetle uses.
3) Deletion of broadcast application from the label; all ornamental uses will be
restricted to spot treatments.
4) The use rate must be limited to 0.3125 Ibs ai/acre and the maximum number of
applications per year must be limited to three.
5) The minimum interval between applications must be increased to one month.
6) The use on shade trees must be limited to those in nurseries and/or greenhouses.
7) Application is limited to high-pressure handwands, low-pressure handwands, and
knapsack/backpack sprayers.
54
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c. Occupational/Residential Labeling
(1) Personal Protective Equipment Requirements for Pesticide Handlers
(mixers, loaders, applicators, etc);
Sole-active-ingredient end-use products that contain fenitrothion must be
revised to adopt the handler personal protective equipment requirements set forth
in this section. Any conflicting PPE requirements on their current labeling must
be removed.
• Handler PPE for Occupational-Use Products (products NOT intended
primarily for home use — (see tests in PR Notice 93-7 and 93-11):
Minimum (Baseline) Personal Protective Equipment Requirements:
Some of the registered uses of fenitrothion are within the scope of the Worker
Protection Standard for Agricultural Pesticides (WPS) and some are outside the
scope of the WPS. The minimum (baseline) PPE requirements pertain to both the
WPS and nonWPS uses by occupational handlers, since the potential exposure to
occupational handlers is similar for WPS and nonWPS uses.
"Applicators and other handlers must wear:
—Coveralls over long-sleeved shirt and long pants
—Chemical-resistant gloves (see instructions * below)
—Chemical-resistant footwear plus socks
—Chemical-resistant headgear for overhead exposure
—Chemical-resistant apron when cleaning equipment, mixing, or
loading" (see instructions ** below)
—Dust/mist filtering respirator (MSHA/NIOSH approval number
prefix TC-21C)
* The glove statement for fenitrothion is the statement established through the
instructions in Supplement Three of PR Notice 93-7.
** The words "mixing, or loading" may be removed if the product is formulated
as "ready-to-use."
Actual End-Use Product Personal Protective Equipment Requirements: The PPE
that would otherwise be established based on the acute toxicity of each end-use
product must be compared to the minimum (baseline) personal protective
equipment, if any, specified above. The more protective PPE requirements must
55
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be placed on the product labeling. For guidance on which PPE is considered more
protective, see PR Notice 93-7.
Placement in Labeling: The personal protective equipment requirements must be
placed on the end-use product labelng in the location specified in PR Notice 93-7
and the format and language of the PPE requirements must be the same as is
specified in PR Notice 93-7.
(2) Entry Restrictions; Labeling
Sole-active-ingredient end-use products that contain fenitrothion must be
revised to adopt the entry restrictions set forth in this section. Any conflicting
entry restrictions on their current labeling must be removed.
• Occupational-Use Products (Products NOT Intended Primarily For
Home Use):
--Uses Within the Scope of the WPS
Restricted-Entry Interval. A restricted entry interval (REI) is required for uses
within the scope of the WPS (see PR Notice 93-7) on all end-use products (see
tests in PR Notices 93-7 and 93-11). This REI must be inserted into the
standardized REI statement required by Supplement Three of PR Notice 93-7.
The Agency is requiring the following entry restrictions for all uses of fenitrothion
within the scope of the Worker Protection Standard:
"Do not enter or allow worker entry into treated areas during the restricted
entry interval (REI) of 48 houis. Each 48-hour REI is increased to 72 hours in
outdoor areas where the average rainfall is less than 25 inches per year."
Early-Entry Personal Protective Equipment (PPE):
There are special risk concerns about fenitrothion since it a toxicological
endpoint of concern for systemic toxicity and the MOE's for handlers were
marginal. The PPE required for early entry following applications of the
fenitrothion is:
—coveralls over long-sleeve shirt and long pants,
—chemical-resistant gloves,
—chemical-resistant footwear plus socks,
—chemical-resistant headgear for overhead exposures, and
—protective eyewear.
56
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User Safety Statements:
The Agency is requiring the following user safety statements to be located on
end-use products containing fenitrothion:
User Safety Requirements:
Discard clothing and other absorbent materials that have been drenched or heavily
contaminated with this product's concentrate. Do not reuse them. Follow
manufacturer's instructions for cleaning/maintaining PPE. If no such instructions
exist for washables, use detergent and hot water. Keep and wash PPE separately
from other laundry.
User Safety Recommendations:
• Users should wash hands before eating, drinking, chewing gum, using
tobacco, or using the toilet.
• Users should remove clothing immediately if pesticide getsinside. Then wash
thoroughly and put on clean clothing.
• Users should remove PPE immediately after handling this product. Wash the
outside of gloves before removing. As soon as possible, wash thoroughly and
change into clean clothing.
d. Environmental Hazard
The following statement is required for end-use products:
ENVIRONMENTAL HAZARD
"This pesticide is toxic to birds and aquatic invertebrates. Do not apply directly to
water or to areas where surface water is present or to intertidal areas below the mean
high water mark. Runoff may be hazardous to aquatc organisms in neighboring areas.
Do not contaminate water when disposing of equipment washwater or rinsate."
C. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling for 26
months from the date of the issuance of this Reregi strati on Eligibility Decision (RED).
Persons other than the registrant maygenerally 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
57
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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 fenitrothion 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 1his 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.
58
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VI. APPENDICES
59
-------
60
-------
APPENDIX A. Table of Use Patterns Subject to
Reregistration
61
-------
62
-------
APPENDIX A ) CASE 0445, [Fenitrothion] Chemical 105901 [Fenitrothion]
SITE Application Type, Application
Form(s) Min. Appl.
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr.
Geographic Limitations
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Rate (AI Tex. @ Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
otherwise) Dose cycle /crop /year
cycle
Interv Entry Allowed
(days) Interv
[day(s)]
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON- FEED
)))))))))))))))))))
BATHROOM PREMISES/HARD SURFACES
Bait application., When needed., By hand. B/S NA
COMMERCIAL STORAGES/WAREHOUSES PREMISES (INDOOR)
Bait application., When needed., By hand. B/S NA
COMMERCIAL/INSTITUTIONAL/INDUSTRIAL PREMISES/EQUIP. (INDOOR)
Bait application., When needed., By hand. B/S NA
COMMERCIAL/INSTITUTIONAL/INDUSTRIAL PREMISES/EQUIPMENT (OUTDOOR)
Bait application., When needed., By hand. B/S NA
HOUSEHOLD/DOMESTIC DWELLINGS
Bait application., When needed., By hand. B/S NA
HOUSEHOLD/DOMESTIC DWELLINGS INDOOR PREMISES
Bait application., When needed., By hand. B/S NA
HOUSEHOLD/DOMESTIC DWELLINGS OUTDOOR PREMISES
Bait application., When needed., By hand. B/S NA
ORNAMENTAL AND/OR SHADE TREES
Bark treatment., Foliar., Sprayer. EC NA
Basal bark treatment., When needed., Hand EC NA
held sprayer.
Use Group: INDOOR RESIDENTIAL
UC * NS NS NS NS AN NS
Use Group: INDOOR NON-FOOD
UC * NS NS NS NS AN NS
Use Group: INDOOR NON-FOOD
UC * NS NS NS NS AN NS
Use Group: TERRESTRIAL NON-FOOD CROP
UC * NS NS NS NS AN NS
Use Group: INDOOR RESIDENTIAL
UC * NS NS NS NS AN NS
Use Group: INDOOR RESIDENTIAL
UC * NS NS NS NS AN NS
Use Group: OUTDOOR RESIDENTIAL
UC * NS NS NS NS AN NS
Use Group: TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL
UC * NS NS NS NS 90 1
Use Group: TERRESTRIAL+GREENHOUSE NON-FOOD CROP
UC * NS NS NS NS 90 1
-------
APPENDIX A ) CASE 0445, [Fenitrothion] Chemical 105901 [Fenitrothion]
SITE Application Type, Application
Form(s) Min. Appl.
Timing, Application Equipment )
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr.
Geographic Limitations
Rate (AI Tex. @ Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
otherwise) Dose cycle /crop /year
cycle
Interv Entry Allowed
(days) Interv
[day(s)]
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
)))))))))))))))))))))))))))
ORNAMENTAL AND/OR SHADE TREES (con't)
Spot treatment., Foliar., Sprayer.
ORNAMENTAL HERBACEOUS PLANTS
Broadcast., Foliar., Sprayer.
Spot treatment., Foliar., Sprayer.
ORNAMENTAL NONFLOWERING PLANTS
Broadcast., Foliar., Sprayer.
Broadcast., Nurserystock., Sprayer.
Spot treatment., Foliar., Sprayer.
Spot treatment., Nurserystock., Sprayer.
ORNAMENTAL WOODY SHRUBS AND VINES
Broadcast., Foliar., Sprayer.
EC NA
EC NA
EC NA
EC NA
EC NA
EC NA
EC NA
EC NA
EC NA
EC NA
EC NA
EC NA
EC NA
EC NA
Use Group: TERRESTRIAL+GREENHOUSE NON-FOOD CROP (con't)
UC * NS NS NS NS 7 1
UC * NS NS NS NS 7 1
UC * NS NS NS NS 7 1
UC * NS NS NS NS 7 1
UC * NS NS NS NS 7 1
UC * NS NS NS NS 7 1
UC * NS NS NS NS 7 1
Use Group: TERRESTRIAL+GREENHOUSE NON-FOOD CROP
UC * NS NS NS NS 7 1
UC * NS NS NS NS 7 1
UC * NS NS NS NS 7 1
UC * NS NS NS NS 7 1
UC * NS NS NS NS 7 1
UC * NS NS NS NS 7 1
UC * NS NS NS NS 7 1
UC * NS NS NS NS 7 1
Use Group: TERRESTRIAL+GREENHOUSE NON-FOOD CROP
UC * NS NS NS NS 7 1
UC * NS NS NS NS 7 1
UC * NS NS NS NS 7 1
UC * NS NS NS NS 7 1
Use Group: TERRESTRIAL+GREENHOUSE NON-FOOD CROP
UC * NS NS NS NS 7 1
C93, C94, CAL
C46
C93, C94, CAL
C46
C93, C94, CAL
C46
C93, C94, CAL
C46
C93, C94, CAL
C46
C93, C94, CAL
C46
C93, C94, CAL
C46
C93, C94, CAL
-------
APPENDIX A ) CASE 0445, [Fenitrothion] Chemical 105901 [Fenitrothion]
SITE Application Type, Application
Form(s) Min. Appl.
Timing, Application Equipment )
Surface Type (Antimicrobial only) s Effica-
cy Influencing Factor (Antimicrobial only)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted
less noted unless noted Max. /crop /year otherwise)/A]
otherwise) otherwise) Dose cycle /crop /year
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
Spot treatment., Foliar., Sprayer.
Use Group: TERRESTRIAL+GREENHOUSE NON-FOOD CROP (con't)
EC
EC
EC
EC
EC
EC
EC
NA
NA
NA
NA
NA
NA
NA
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 7 1
NS 7 1
NS 7 1
NS 7 1
NS 7 1
NS 7 1
NS 7 1
C93, C94,
C46
C93, C94,
C46
C93, C94,
C46
C93, C94,
CAL
CAL
CAL
CAL
NOT SPECIFIED
EATING ESTABLISHMENTS
Bait application., When needed., By hand. B/S NA
-------
APPENDIX A ) CASE 0445, [Fenitrothion] Chemical 105901 [Fenitrothion]
LEGEND
444444
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).
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"
Maximum dose applied to a site over a single crop cycle or year. System calculated.
Max. # Apps @ Max. Rate
Max. Dose [(AI unless
noted otherwise)/A]
Min. Interv (days)
Restr. Entry Interv (days)
PRO Report Date
Minimum Interval between Applications (days)
Restricted Entry Interval (days)
LUIS contains all products that were active or suspended (and that were available from OPP Document Center) as of this date. Some products
registered after this date may have data included in this report, but LUIS does not guarantee that all products registered after this date have
data that has been captured.
SOIL TEXTURE FOR MAX APP. RATE
Non-specific
Coarse
M Medium
F Fine
Others
FORMULATION CODES
B/S
EC
WP
ABBREVIATIONS
BAIT/SOLID
EMULSIFIABLE CONCENTRATE
WETTABLE POWDER
As Needed
Not Applicable
Not Specified (on label)
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
Dosage Can Not be Calculated
No Calculation can be made
PPM calculated by weight
PPM Calculated by volume
Unknown whether PPM is given by weight or by volume
Hundred Weight
nn times (10 power -xx); for instance, "1.234E-04" is equivalent to ".0001234"
USE LIMITATIONS CODES
Do not apply through any type of irrigation system.
Do not apply directly to water.
Runoff from treated areas may be hazardous to aquatic organisms in neighboring areas.
Do not apply where runoff is likely to occur.
Do not contaminate water, food or feed.
Do not contaminate food or feed.
NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.
-------
APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
67
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68
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GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case Fenitrothion covered by this Reregistration Eligibility Decision
Document. It contains generic data requirements that apply to Fenitrothion 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.
69
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70
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APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Fenitrothion
REQUIREMENT USE PATTERN CITATION(S)
PRODUCT CHEMISTRY
61-1 Chemical Identity
61-2A Start. Mat. & Mnfg. Process
61-2B Formation of Impurities
62-1 Preliminary Analysis
62-2 Certification of limits
62-3 Analytical Method
63-2 Color
63-3 Physical State
63-4 Odor
63-5 Melting Point
63-6 Boiling Point
63-7 Density
63-8 Solubility
63-9 Vapor Pressure
63-10 Dissociation Constant
63-11 Octanol/Water Partition
63-12 pH
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
40124301, letter dated 11/17/92, 42815801, Itr
with CSF dated 10/19/93
00150221, 00128047, 41423201, 41679401
00150221, 40124301
00150221, 40124302, letter dated 11/17/92
40124302, 42815801, Itr dated 10/19/93
00150221, 00126960, 00128033, 00079252,
41621701, letter dated 11/17/92
00150221, 00163504
00150221, 00163504
00150221, 00163504
00163504
00150221, 00126960, 00163504
00150221, 00163504
00126960, 00150221, 00163504
00163504
00163504
00163504
00163504
71
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Data Supporting Guideline Requirements for the Reregistration of Fenitrothion
REQUIREMENT
USE PATTERN
CITATION(S)
63-13 Stability
63-14 Oxidizing/Reducing Action
63-15 Flammability
63-16 Explodability
63-17 Storage stability
63-18 Viscosity
63-19 Miscibility
63-20 Corrosion characteristics
ECOLOGICAL EFFECTS
71-1A
Acute Avian Oral - Quail/Duck
All
All
All
All
All
All
All
All
C
00088340, 00126960, 00150221, 00163504
40124303
00163504
40124303
00163504
42632301
40124303
00163504, 42632401
00126885
71-1B Acute Avian Oral - Quail/
(Degradate)
71-2A Avian Dietary - Quail
71-2B Avian Dietary - Duck
71-4A Avian Reproduction - Quail
71-4A Avian Reproduction -
Quail (Degradate)
71-4B Avian Reproduction - Duck
72-1A Fish Toxicity Bluegill
C
C
C
C
C
C
C
DATA GAP
00022923
00022923
41958401
Reserved - Pending results of 74-1 studies
41243502
(Partially fulfilled)
40094602
72
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Data Supporting Guideline Requirements for the Reregistration of Fenitrothion
REQUIREMENT
72-1B
72-1C
72-1D
72-2A
72-2B
72-3A
72-3B
72-3C
72-3D
72-3E
72-3F
72-4A
72-4B
72-5
72-6
Fish Toxicity Bluegill -
(Degradates)
Fish Toxicity Rainbow Trout
Fish Toxicity Rainbow Trout -
(Degradate)
Invertebrate Toxicity
Invertebrate Toxicity - Daphnia
Magna (Degradate)
Estuarine/Marine Toxicity - Fish
Estuarine/Marine Toxicity -
Mollusk
Estuarine/Marine Toxicity -
Shrimp
Estuarine/Marine Toxicity Fish -
(Degradate)
Estuarine/Marine Toxicity Mollusk
- (Degradate)
Estuarine/Marine Toxicity Shrimp
- (Degradate)
Early Life Stage Fish
Life Cycle Invertebrate
Life Cycle Fish
Aquatic Organism Accumulation
USE PATTERN
N/A
C
N/A
C
C
C
C
C
N/A
N/A
N/A
C
C
N/A
N/A
CITATION(S)
N/A
40094602
N/A
00120401
Data Gap
40228401
40228401
40228401
N/A1
N/A2
N/A3
40891201
40891101
N/A
N/A
73
-------
Data Supporting Guideline Requirements for the Reregistration of Fenitrothion
REQUIREMENT
72-7A
72-7B
141-1
141-2
141-5
Simulated Field - Aquatic
Organisms
Actual Field - Aquatic Organisms
Honey Bee Acute Contact
Honey Bee Residue on Foliage
Field Test for Pollinators
USE PATTERN
N/A
N/A
C
C
N/A
CITATION(S)
N/A
N/A
05001991
00126931
N/A
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
81-7
82-1A
82-1B
82-2
82-3
82-4
82-5A
82-5B
Acute Oral Toxicity - Rat
Acute Dermal Toxicity -
Rabbit/Rat
Acute Inhalation Toxicity - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
Dermal Sensitization - Guinea Pig
Acute Delayed Neurotoxicity - Hen
90-Day Feeding - Rodent
90-Day Feeding - Non-rodent
21 -Day Dermal - Rabbit/Rat
90-Day Dermal - Rodent
90-Day Inhalation - Rat
90-Day Neurotoxicity - Hen
90-Day Neurotoxicity - Mammal
All
All
All
All
All
All
All
L
L
I
N/A
I
N/A
All
00061091
00071960
DATA GAP
00127970
00062976, 00105950
00069955
00069955
00071965
00143017
42058301
N/A
40891001
N/A
00069955
74
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Data Supporting Guideline Requirements for the Reregistration of Fenitrothion
REQUIREMENT
USE PATTERN
CITATION(S)
83-1A Chronic Feeding Toxicity - Rodent All
83-IB Chronic Feeding Toxicity - L
Non-Rodent
83-2A Oncogenicity - Rat L
83-2B Oncogenicity - Mouse L
83-3A Developmental Toxicity - Rat L
83-3B Developmental Toxicity - Rabbit L
83-4 2-Generation Reproduction - Rat L
84-2A Gene Mutation (Ames Test) L
84-2B Structural Chromosomal L
Aberration
84-4 Other Genotoxic Effects L
85-1 General Metabolism L
85-2 Dermal Penetration N/A
86-1 Domestic Animal Safety N/A
OCCUPATIONAL/RESIDENTIAL EXPOSURE
132-1A Foliar Residue Dissipation C
132-IB Soil Residue Dissipation N/A
133-3 Dermal Passive Dosimetry C,I
Exposure
133-4 Inhalation Passive Dosimetry C,I
Exposure
00143017, 40420501
40420501
00071965
41925201, 42507701, 42507702, 42507703,
42507704
40604002
00162548, 40430601
41689001, 42668801
00163432
40789201
40789202
00069960, 40408906
N/A
N/A
DATA GAP
N/A
DATA GAP
DATA GAP
75
-------
Data Supporting Guideline Requirements for the Reregistration of Fenitrothion
REQUIREMENT
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
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
162-3 Anaerobic Aquatic Metabolism
162-4 Aerobic Aquatic Metabolism
163-1 Leaching/Adsorption/Desorption
163-2 Volatility - Lab
USE PATTERN CITATION(S)
C,I DATA GAP
C,I DATA GAP
C,I DATA GAP
C,I DATA GAP
C 00090500, 40717901
C 00061839, 00088273,
00159952, 00159953
C 00088273, 40865501
N/A WAIVED
C 00126945, 00159950
00061842, 41295101
N/A N/A
C 00061842, 00159949
00159950, 41615701
N/A N/A
C 00061842, 00126947,
00159951, 00159956,
40420502
C 41148902
76
-------
Data Supporting Guideline Requirements for the Reregistration of Fenitrothion
REQUIREMENT
163-3
164-1
164-2
164-3
164-5
165-1
165-2
165-3
165-4
165-5
166-1
166-2
166-3
201-1
202-1
RESIDUE
171-4A
171-4B
Volatility - Field
Terrestrial Field Dissipation
Aquatic Field Dissipation
Forest Field Dissipation
Long Term Soil Dissipation
Confined Rotational Crop
Field Rotational Crop
Accumulation - Irrigated Crop
Bioaccumulation in Fish
Bioaccumulation - Aquatic
NonTarget
Ground Water - Small Prospective
Ground Water - Small
Retrospective
Ground Water - Irrigated
Retrospective
Droplet Size Spectrum
Drift Field Evaluation
CHEMISTRY
Nature of Residue - Plants
Nature of Residue - Livestock
USE PATTERN
N/A
C
N/A
N/A
N/A
N/A
N/A
N/A
C
N/A
N/A
N/A
N/A
N/A
N/A
L4
N/A
CITATION(S)
N/A
DATA GAP
N/A
N/A
N/A
N/A
N/A
N/A
40847001, 41654001
N/A
N/A
N/A
N/A
N/A
N/A
00069962, 00069963, 00113146
N/A
77
-------
Data Supporting Guideline Requirements for the Reregistration of Fenitrothion
REQUIREMENT
171-4C
171-4D
171-4E
171-4F
171-4J
171-4K
171-4L
171-5
Residue Analytical Method - Plants
Residue Analytical Method -
Animal
Storage Stability
Magnitude of Residues - Potable
H2O
Magnitude of Residues -
Meat/Milk/Poultry/Egg
Crop Field Trials
Processed Food
Wheat gluten
Reduction of Residues
USE PATTERN
L
N/A
L
N/A
N/A
N/A
L
N/A
CITATION(S)
00062928, 00113146, 00135034, 41468701,
41000801, 41679402
N/A
00150219, 00150223, 41468701, 41000802
N/A
N/A
N/A
00113146, 00150224, FAO/WHO(1974),
FAO/WHO(1979), 41468701, Itr dated
11/17/92
N/A
1 - This study is not required provided the registrants revised all ornamental labels to restrict uses on shade trees to only those in
nurseries.
2 - This study is not required provided the registrants revised all ornamental labels restrict uses on shade trees to only those in
nurseries.
3 - This study is not required provided the registrants revised all ornamental labels restrict uses on shade trees to only those in
nurseries.
4 - Fenitrothion is not registered for use on food or feed commodities in the United States. Data were required to support the
tolerance for wheat gluten imported into this country.
78
-------
APPENDIX C. Citations Considered to be Part of the Data
Base Supporting the Reregistration of Fenitrothion
79
-------
80
-------
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
81
-------
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.
82
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BIBLIOGRAPHY
MRID
CITATION
00022923 Lethal Dietary Toxicities of Environmental Pollutants to Birds (1975). U.S.
Fish and Wildlife Service, Special Scientific Report—Wildlife No. 191.
Patuxent Wildlife research Center; Laurel, MD.
00061091 Miyamoto, J.; Kadota, T. (1972) Toxicological Studies with Sumithion.
(Unpublished study received on unknown date under unknown admin, no.;
submitted by Sumitomo Chemical Co., Ltd., Baltimore, Md.; CDL:127719-B)
00061839 Ohkawa, H.; Mikami, N.; Miyamoto, J. (1974) Photodecomposition of
Sumithion. Agricultural and Biological Chemistry 38(11): 2247-2255. (Also in
unpublished submission received Mar 19, 1976 under 10308-2; submitted by
Sumitomo Chemical Co., Ltd., Baltimore, Md.; CDL:227775-F)
00061842 Takimoto, Y.; Hirota, M.; Inui, H.; et al. (1975) Decomposition and Leaching
of Radioactive Sumithion in 4 Different Types of Soil under Laboratory
Conditions. (Unpublished study received Mar 19, 1976 under 10308-2;
prepared by Sumitomo Chemical Co., Ltd., Japan, submitted by Sumitomo
Chemical Co., Ltd., Baltimore, Md.; CDL:227775-I)
00062928 Patchett, G.G. (1976) Determination of Residues of Sumithion and Sumioxon in
Crops and Soil. Method no. RRC 76-50 dated Nov 23, 1976. (Unpublished
study received Dec 8, 1980 under 476-EX-100; submitted by Stauffer Chemical
Co., Richmond, Calif.; CDL: 243935-E)
00062976 Saunders, D.R. (1978) Toxicity Evaluation: Sumithion 8E: Toxicology
Laboratory Report: T-6290. (Unpublished study received Dec 8, 1980 under
476-EX-100; submitted by Stauffer Chemical Co., Richmond, Calif.;
CDL:243934-A)
00069955 Miyamoto, J.; Kadota, T.; Kagoshima, M. (1976) Acute Oral Toxicity and
Delayed Neurotoxicity of Sumithion in Hens. Rev. (Unpublished study,
including letter dated Aug 26, 1976 from N. Ito to J. Miyamoto, received Feb
28, 1978 under 476-EX-80; prepared by Sumitomo Chemical Co., Ltd., Japan,
submitted by Stauffer Chemical Co., Richmond, Calif.; CDL:096826-D)
83
-------
BIBLIOGRAPHY
MRID
CITATION
00069960 Miyamoto, J.; Mihara, K.; Hosokawa, S. (1974) Comparative Metabolism of
Carbon-14 Sumithion in Rats, Rabbits and Dogs. Interim rept. (Unpublished
study received Feb 28, 1978 under 476-EX-80; prepared by Sumitomo
Chemical Co., Ltd., Japan, submitted by Stauffer Chemical Co., Richmond,
Calif.; CDL:096826-I)
00069962 Hosokawa, S.; Miyamoto, J. (1974) Metabolism of labelled Sumithion in
apples. Botyu-Kagaku 39(11):49-53. (Also in unpublished submission received
Feb 28, 1978 under 476-EX-80; submitted by Stauffer Chemical Co.,
Richmond, Calif.; CDL: 096826-L)
00069963 Miyamoto, J.; Sato, Y. (1965) Determination of insecticide residue in animal
and plant tissues: II. Metabolic fate of Sumithion in rice plant applied at the
preheading stage and its residue in harvested grains. Botyu-Kagaku
30(11):45-49. (Also in unpublished submission received Feb 28, 1978 under
476-EX-80; submitted by Stauffer Chemical Co., Richmond, Calif.;
CDL:096826-M)
00071960 Miyamoto, J.;Kadota, T. (1972) Toxicological Studies with Sumithion.
(Unpublished study received dec 1, 1976 under 476-EX-80; prepared by
Sumitomo Chemical Co., Ltd., Japan, submitted by Stauffer Chemical Co.,
Richmond, CA; CDL:094670-B)
00071965 Rutter, H.A., Jr.; Kundzins, W.; Nelson, L.W. (1974) Final Report: Two-year
Dietary Administration in the Rat: Project No. 343-107. (Unpublished study
received Dec 1, 1976 under 476-EX-80; prepared by Hazleton Laboratories,
Inc., submitted by Stauffer Chemical Co., Richmond, Calif.; CDL:096470-G)
00079252 A/S Cheminova (1977) Determination of inert ingredient Content in Methyl
Parathion, Ethyl Parathion, Novathion (Fenitrothion) and Fyfanon (Malathion).
Method AM 5 dated Oct 11, 1977. Unpublished study; 2 p.
00088273 Mikami, N.; Ohkawa, H.; Miyamoto, J. (1976) Photodecomposition of
Sumithion: (Supplementary Studies). (Unpublished study received Feb 2, 1978
under 476-EX-95; prepared by Sumitomo Chemical Co., Ltd., Japan, submitted
by Stauffer Chemical Co., Richmond, Calif.; CDL:232962-N)
84
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BIBLIOGRAPHY
MRID
CITATION
00088340 Ohkawa, H.; Mikami, N.; Miyamoto, J. (1974) Photodecomposition of
Sumithion. (Unpublished study received Jul 1, 1974 under 10308-2; prepared
by Sumitomo Chemical Co., Ltd., Japan, submitted by Sumitomo Chemical
Co., Ltd., Baltimore, Md.; CDL: 120354-1)
00090500 Takimoto, Y.; Hirota, M. (1974) Stability of Sumithion in Water. (Unpublished
study received Dec 14, 1977 under 476-EX-4; prepared by Sumitomo Chemical
Co., Ltd., submitted by Stauffer Chemical Co., Richmond, Calif.;
CDL:232476-K)
00105950 Castles, T. (1978) Toxicity Evaluation: Sumithion 8E: Toxicology Laboratory
Report T-6290. (Unpublished study received Jun 20, 1980 under 476-2197;
submitted by Stauffer Chemical Co., Richmond, CA; CDL:242693-A)
00113146 Sumitomo Chemical America, Inc. (1979) Mature Seeds of Grain Crops:
Sumithion. (Compilation; unpublished study received Jun 6, 1979 under
39398-3; CDL:098318-A)
00120401 Woodward, D.; Mauck, W. (1980) Toxicity of five forest insecticides to
cutthroat trout and two species of aquatic invertebrates. Bull. Environm.
Contam. Toxicol. 25:846-854. (Submitter 69597; also in unpublished
submission received Dec 9, 1982 under 3125327; submitted by Mobay
Chemical Corp., Kansas City, MO; CDL: 248989-0)
00126885 Fletcher, D. (1971) Acute Oral Toxicity Study with Sumithion in Ringneck
Pheasants: IBT No. J9993. (Unpublished study received Mar 15, 1973 under
10308-2; prepared by Industrial Bio-Test Laboratories, Inc., submitted by
Sumitomo Chemical Co., Ltd., Baltimore, MD; CDL:004891-B)
00126931 Johansen, C.; Atkins, E. (1978) Bee Toxicology: Sumithion SEC: TEst No.
I-59-P-78. (Unpublished study received Feb 6, 1979 under 476-EX-80;
prepared by Washington State Univ., Dept. of Entomology and Univ. of
California—Riverside, Dept. of Entomology, submitted by Stauffer Chemical
Co., Richmond, CA; CDL: 097792-C)
00126945 Sumitomo Chemical America, Inc. (1977) Sumithion Degradation Study in
Forest Soil: Project 149046. Monthly rept., Feb. (Unpublished study received
Aug 17, 1977 under 39398-3; CDL:231306-J)
85
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BIBLIOGRAPHY
MRID
CITATION
00126947 Spillner, C., Neuberger, A. (1977) Sumithion Adsorption and Desorption in
Various Soils: Project 149046. (Unpublished study received Aug 17, 1977
under 39398-3; submitted by Sumitomo Chemical America, Inc., New York,
NY; CDL:231306-L)
00126960 Sumitomo Chemical America, Inc. (1978) Toxicity, Chemistry and Packaging
Information for Insecticides. (Compilation; unpublished study received Jan 4,
1979 under 39398-9; CDL:236690-A)
00127970 Howell, A. (undated) Ocular Irritation of Sumithion 8E Insecticide on Rabbits:
T-6290. (Unpublished study received Apr 11, 1983 under 39398-EX-l;
prepared by Stauffer Chemical Co., submitted by Sumitomo Chemical America,
Inc., New York, NY; CDL:250075-A)
00128033 American Cyanamid Co. (1970) Chemical Study: Accothion. (Compilation;
unpublished study received Apr 13, 1970 under 241-216; CDL:050944-D)
00128047 Sumitomo Chemical Co., Ltd. (19??) Chemical Study: Sumithion Technical.
(Compilation; unpublished study received Feb 9, 1973 under unknown admin.
no.; CDL:127717-A)
00135034 Stauffer Chemical Co. (1976) The Results of Tests on the Amount and Nature
of the Residue, and Analytical Methodology Using Sumithion. (Compilation;
unpublished study received Dec 1, 1976 under 476-EX-80; CDL:096472-A)
00143017 Griggs, L.; Jefferson, N.; Blair, M.; et al. (1984) One Year Dietary Toxicity
Study in Dogs: Amendment to the Final Report: 491011. Unpublished study
prepared by International Research and Development Corp. 320 p.
00150219 Taylor, R. (1980) Frozen Stability Studies on Sumithion, Sumioxion,
Aminosumithion, and 3-methyl-4-nitrophenol in Tissues and Milk: T-10416.
Unpublished study prepared by Harris Labs, Inc. 190 p.
00150220 Mihara, Y.; Okuno, Y.; Mikami, Y.; et al. (1979) Supplementary Metabolism
Study of Fenitrothion in Female Goat: Final Report: HT-70-0101-3.
Unpublished study prepared by Sumitomo Chemical Co., Ltd. 16 p.
86
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BIBLIOGRAPHY
MRID
CITATION
00150221 Sumitomo Chemical America, Inc. (1985) The Name, Chemical Identity and
Composition of the Pesticide Chemical: Sumitomo 8-E: Section A.
Unpublished compilation. 66 p.
00150223 Taylor, R. (1980) Frozen Stability Studies on Sumithion Sumioxon and
3-Methyl-4-nitrophenol in Poultry Tissue and Eggs: Projects Nos. T-1149 &
T-1150. Unpublished study prepared by Harris Labs., Inc. 135 p.
00150224 McKay, J. (1981) Letter sent to E.R. Butts dated Jan 28, 1981: Analytical data
from Sumithion stored grain study: Project No. 149046. 9 p.
00159949 Adhya, T.; Barik, S.; Sethunathan, N. (1981) Stability of commercial
formulation of fenitrothion, methyl parathion, and parathion in aerobic soils. J.
Agric. Food Chem. 29(l):90-93.
00159950 Mikami, N.; Sakata, S.; Yamada, H.; et al. (1985) Further studies on
degradation of fenitrothion in soils. J. Pesticide Sci. 10 (3):491-500.
00159951 Mikami, N.; Yoshimura, J.; Matsuda, T.; et al. (1984) Leaching Behaviors of
Fenitrothion and Its Degradation Products in Soils. Unpublished study prepared
by Sumitomo Chemical Co., Takarazuka Research Center. 19 p.
00159952 Mikami, N.; Imanishi, K.; Yamada, H.; et al. (1985) Photodegradation of
fenitrothion in water and on soil surface, and its hydrolysis in water. J.
Pesticide Sci. 10(2):263-272.
00159953 Takimoto, Y. (1984) Studies on the Fate in the Aquatic Environment and
Effects on the Aquatic Organisms of an Organophosphorus Insecticide
Fenitrothion. Unpublished dissertation paper to Kyoto University. 153 p.
00159956 Baarschers, W.; Elvish, J.; Ryan, S. (1983) Adsorption of fenitrothion and
3-methyl-4-nitrophenol on soils and sediment. Bull. Environ. Contam.
Toxicol. 30:621-627.
00162548 Morseth, S. (1986) Teratology Study in Rabbits: Fenitrothion T.G.
(Sumithion): Final Report: Project No. 343-182. Unpublished study prepared
by Hazleton Laboratories America, Inc. 141 p.
87
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BIBLIOGRAPHY
MRID
CITATION
00163432 Suzuki, H.; Miyamoto, J. (1983) Mutagenicity Tests of Sumithion with Nitro
Reductase-defective Bacteria: HT-30-0259. Unpublished study prepared by
Sumitomo Chemical Co., Ltd. 13 p.
00163504 Sumitomo Chemical Co., Ltd. (1986) Physical and Chemical Characteristics of
Technical Grade of Active Ingredient: HP-60-0063. Unpublished compilation.
7 p.
00232484 Acute Toxicity Handbook of Chemicals to Estuarine Organisms (1986).
Prepared by Environmental Research Laboratory, Gulf Breeze, FL.
EPA/600/X-86/231. 264 p.
05001991 Stevenson, J.H. (1978) The acute toxicity of unformulated pesticides to worker
honey bees (Apis mellifera). Plant Pathology 27(1):38-40.
40094602 Johnson, W.; Finley, M. (1980) Handbook of Acute Toxicity of Chemicals to
Fish and Aquatic Invertebrates: resource Publication 137. USDI, Fish and
wildlife service, Washington, D.C. 98 p.
40124300 Sumitomo Chemical Co., Ltd. (1987) Submission of Product Chemistry Data in
Response to Fenitrothion Data Call-in Notice. Transmittal of 3 studies.
40124301 Fujinami, A. (1987) Product Identity & Composition of Fenitrothion: Project
No. HP-70-0064; HP-70-0065. Unpublished compilation prepared by
Sumitomo Chemical Co., Ltd. 17 p.
40124302 Fujinami, A. (1987) Analysis & Certification of Product: Fenitrothion: Project
No. HP-70-0067; HP-70-0068. Unpublished compilation prepared by
Sumitomo Chemical Co., Ltd. 31 p.
40124303 Fujinami, A. (1987) Physical and Chemical Characteristics of Sumithion.
Unpublished compilation prepared by Sumitomo Chemical Co., Ltd. 3 p.
40228401 Mayer, F. (1986) Acute Toxicity Handbook of Chemicals to Estuarine
Organisms; EPA/600/X-86/321. Prepared by US EPA Environmental research
Laboratory, Gulf Breeze, FL. 275 p.
40408906 Miyamoto, K. (1976) Comparative Metabolism of m-Methyl-14C-Sumithion in
Several Species of Mammals in vivo. Published in J. Pesticide Sci. 1, 9-21.
-------
BIBLIOGRAPHY
MRID
CITATION
40420500 Sumitomo Chemical America, Inc. (1987) Submission of Data for the
Registration of Fenitrothion. Transmittal of 3 studies.
40420501 Kadota, T.; Kohda, H.; Miyamoto, J. (1974) Ninety-two Week Feeding Study
of Sumithion in Rats with Special Reference of Cholonesterase Activity: Ref.
Nos. HT-50-0001, HT-70-1001: Published in Scientific Pest Control, Vol. 43.
Unpublished study prepared by Sumitomo Chemical Co. 61 p.
40420502 Spillner, C.; Neuberger, A. (1979) Adsorption and Desorption of Sumithion in
Various Soils: Ref. No. HW-91-0188. Unpublished study prepared by Stauffer
Chemical Co. 20 p.
40430600 Sumitomo Chemical America, Inc. (1987) Submission of Data To Support the
Registration of Fenitrothion: Teratology Study. Transmittal of 1 study.
40430601 Morseth, S.; Serabian, M.; Lichterberger, J.; et al. (1987) RangeFinding and
Actual Teratology Study in Rabbits with Fenitrthion T. G. (Sumithion): Revised
(HT-61-0366 & 0367): Hazleton Project No.: 343-181 & 343-182.
Unpublished study prepared by Hazleton Laboratories America, Inc. 257 p.
40604000 Sumitomo Chemical America, Inc. (1988) Submission of Toxicity Data on
Sumithion in Support of the Fenitrothion Registration Standard. Transmittal of
2 studies.
40604002 Morseth, S. (1987) Teratology Study in Rats with Sumithion (HT-710382):
Laboratory Project ID HLA 343-193. Unpublished study prepared by Hazleton
Laboratories America, Inc. 223 p.
40717900 Sumitomo Chemical America, Inc. (1988) Submission of Environmental Data in
Support of Fenitrothion Registration Standard. Transmittal of 2 studies.
40717901 Takahashi, N. (1988) Hydrolysis of Fenitrothion in Water as a Function of pH
at 25 degrees C: Laboratory Project ID: HM-80-0094. Unpublished study
prepared by Sumitomo Chemical Co., Ltd. 77 p.
40789200 Sumitomo Chemical America, Inc. (1988) Submission of Toxicological Data to
Support the Fenitrothion Registration Standard. Transmittal of 2 studies.
89
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BIBLIOGRAPHY
MRID
CITATION
40789201 Kogiso, S. (1988) In vitro Chromosomal Aberration Test of Sumithion in
Chinese Hamster Ovary Cells (CHO-kl) in Culture: Project No. 1386.
Unpublished study prepared by Sumitomo Chemical Co., Ltd. 21 p.
40789202 Kogiso, S. (1988) In vitro Unscheduled DNA Synthesis (UDS) Assay of
Sumithion in Rat Hepatocytes: Project No. 1281. Unpublished study prepared
by Sumitomo Chemical Co., Ltd. 50 p.
40847000 Sumitomo Chemical America, Inc. (1988) Submission of Toxicity Data in
Support of Fenitrothion Registration Standard. Transmittal of 1 study.
40847001 Ohshima, N.; Takahashi, N.; Mikami, N. (1988) Accumulation and
Metabolism of Carbon 14-Fenitrothion in Bluegill Sunfish (Lepomis
macrochirus): Laboratory Project ID: HM-80-0095. Unpublished study
prepared by Sumitomo Chemical Co., Ltd. 74 p.
40865500 Sumitomo Chemical America, Inc. (1988) Submission of Environmental Fate
Data in Support of the Fenitrothion Registration Standard. Transmittal of 1
study.
40865501 Dykes, J.; Carpenter, M. (1988) Photodegradation Study of Carbon
14-Fenitrothion on Soil Surface: ABC Amended Final Report No. 36677.
Unpublished study prepared by Analytical Bio-Chemistry Laboratories, Inc. 80
P-
40891000 Sumitomo Chemical America, Inc. (1988) Submission of Toxicity Data in
Support of the Fenitrothion Registration Standard. Transmittal of 1 study.
40891001 Coombs, D.; Keeny, T.; Hardy, C.; et al. (1988) Sumithion T. G. 90Day
Inhalation Study in the Rat: Project No. SMO 300/881214. Unpublished study
prepared by Huntingdon Research Centre Ltd. 327 p.
40891100 Sumitomo Chemical Co., Ltd. (1988) Submission of Toxicity Data in Support
of the fenitrothion Registration Standard. Transmittal of 1 study.
40891101 Burgess, D. (1988) Chronic Toxicity of Fenitrothion Technical to Daphnia
magna Under Flow-through Test Conditions: Final Report No. 36648.
Unpublished study prepared by Analytical Bio-Chemistry Laboratories, Inc.
458 p.
90
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BIBLIOGRAPHY
MRID
CITATION
40891200 Sumitomo Chemical Co., Ltd. (1988) Submission of Toxicity Data in Support
of the Fenitrothion Registration Standard. Transmittal of 1 study.
40891201 Cohle, P. (1988) Early Life Stage Toxicity of Fenitrothion Technical to
Rainbow Trout (Salmo gairdneri) in a Flow-through System: Final Report No.
36647. Unpublished study prepared by Analytical Bio-Chemistry Laboratories,
Inc. 1009 p.
41000800 Sumitomo Chemical America, Inc. (1989) Submission of Residue Studies to
Support the Fenitrothion Registration Standard. Transmittal of 2 studies.
41000801 Ohnish, J.; Hirota, M.; Matsuda, T.; et al (1989) Multiresidue Analytical
Method for Fenitrothion, Fenitrooxon and 3-methyl-4nitrophenol in Wheat
Grain and Gluten: Proj. ID HA-90-0183. Unpublished study prepared by
Sumitomo Chemical Co., Ltd. 50 p.
41000802 Turnbull, S.; Roubos, H. (1989) Determination of Fenitrothion, Fenitrooxon
and 3-methyl-4-nitrophenol in Wheat and Gluten Storage Stability: Proj. No.
HR-91-0124. Unpublished study prepared by The Wellcome Foundation Ltd.
29 p.
41148900 Sumitomo Chemical America, Inc. (1989) Submission of Environmental Fate
Data in Support of the Fenitrothion Registration Standard. Transmittal of 2
studies.
41148902 Schofield, C. (1989) Laboratory Volatility from Soil of Fenitrothion: Project
ID 36679. Unpublished study prepared by Analytical Bio-Chemistry
Laboratories. 35 p.
41243500 Sumitomo Chemical America, Inc. (1989) Submission of Toxicity Data in
Support of the Fenitrothion Registration Standard. Transmittal of 2 studies.
41243501 Beavers, J.; Lloyd, D.; Jaber, M. (1989) Sumithion Technical Grade: A
One-generation Reproduction Study with the Bobwhite (Colinus virginianus):
Project ID 166-119. Unpublished study prepared by Wildlife International Ltd.
212 p.
91
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BIBLIOGRAPHY
MRID
CITATION
41243502 Beavers, J.; Lloyd, D.; Jaber, M. (1989) Sumithion Technical Grade: A
One-generation Reproduction Study with the Mallard (Anas platyrhynchos):
Project ID 166-120. Unpublished study prepared by Wildlife International Ltd.
208 p.
41295100 Sumitomo Chemical America, Inc. (1989) Submission of Soil Metabolism Data
to Support the Fenitrothion Registration Standard. Transmittal of 1 study.
41295101 Cranor, W.; Daly, D. (1989) Aerobic Soil Metabolism of Carbon
14-Fenitrothion: Lab Project Number: 36674. Unpublished study prepared by
Analytical Bio-Chemistry Laboratories, Inc. 55 p.
41423200 Sumitomo Chemical America, Inc. (1990) Submission of Product Chemistry
Data to Support the Fenitrothion Registration Standard. Transmittal of 1 study.
41423201 Kato, T. (1990) Description of Beginning Materials and Manufacturing Process
for Fenitrothion: Supplemental Report to MRID No. 40124301. Unpublished
study prepared by Sumitomo Chemical Co., Ltd. 38 p.
41468700 Sumitomo Chemical America, Inc. (1990) Submission of storage stability data
to support fenitrothion registration standard. Transmittal of 1 study.
41468701 Sumitomo Chemical Co. (1990) Determination of Fenitrothion, Fenitrooxon
and 3-Methyl-4-nitrophenol in Wheat and Gluten: Lab Project No. R8834/059.
Unpublished study prepared by Wellcome Australia Ltd. 91 p.
41615700 Sumitomo Chemical Company, Ltd. (1990) Submission of Environmental Fate
Data to Support the Fenitrothion Registration Standard. Transmittal of 1 Study.
41615701 Cranor, W.; Daly, D. (1990) Anaerobic Aquatic Metabolism of Carbon 14
Fenitrothion: Lab Project Number: 36675. Unpublished study prepared by
Analytical Bio-Chemistry Laboratories, Inc. 71 p.
41621700 Sumitomo Chemical America, Inc. (1990) Submission of Data To Support
Fenitrothion Registration Standard Requirements: Product Chemistry Study.
Transmittal of 1 study.
92
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BIBLIOGRAPHY
MRID
CITATION
41621701 Sakaue, S. (1990) Analytical Methods to Verify Certified Limits of Sumithion
Technical Preparation: Lab Project Number: HA-00-0197. Unpublished study
prepared by Sumitomo Chemical Co., Ltd. 36 p.
41654000 Sumitomo Chemical Co., Ltd. (1990) Submission of environmental fate data
(accumulation in bluegill) to support the registration standard for fenitrothion
(Sumithrin). Transmittal of 1 study.
41654001 Oshima, M.; Mikami, N. (1990) Characterization of Unidentified Metabolites
of Fenitrothion in Bluegill Sunfish: Lab Project Number ACC90002: REF.
HM-00-0115. Unpublished study prepared by Sumitomo Chemical Co., Ltd.
59 p.
41679400 Sumitomo Chemical Co., Ltd. (1990) Submission of Chemistry and Residue
Data in Support of Fenitrothion Registration Standard. Transmittal of 2 studies.
41679401 Kato, T. (1990) Description of Beginning Materials of Fenitrothion: Lab
Project Number: HP-00-0091. Unpublished study prepared by Sumitomo
Chemical Co., Ltd. 9 p.
41679402 Rushland, J. (1990) Multiresidue Protocol Evaluation for 3-Methyl-4
-Nitrophenol HA-01-0196: Lab Project Number: HLA 6012-292. Unpublished
study prepared by Hazleton Laboratoreis America, Inc. 156 p.
41689000 Sumitomo Chemical America, Inc. (1990) Submission of Toxicity data in
support of the Fenitrothion registration standard. Transmittal of 1 study.
41689001 Hoberman, A. (1990) Reproductive Effects of Sumithion Administered Orally
in Feed to Crl:CD(SD)BR Rats for two Generations: Lab Project Number:
1119-008: HT-01-0452. Unpublished study prepared by Argus Research
Laboratories, Inc. 1168 p.
41925200 Sumitomo Chemical America, Inc. (1991) Submission of toxicity/ oncogenicity
data to support the registration standard for Fenitrothion (Sumithion).
Transmittal of 1 study.
41925201 Tamano, S. (1990) Chronic Dietary Toxicity and Carcinogenicity Test of
Sumithion Technical in Mice: Lab Project Number: 8425/8426. Unpublished
study prepared by Daiyu-Kai Institute of Medical Science. 2735 p.
93
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BIBLIOGRAPHY
MRID
CITATION
41958400 Sumimoto Chem. Co. (1991) Submission of toxicity data in support of a
registration standard for fenitrothion. Transmittal of 1 study.
41958401 Beavers, J.; Ross, T.; Smith, G.; et al. (1991) Sumithion Technical Grade: A
One-Generation Reproduction Study with the Bobwhite (Colinus virginianus):
Lab Project Number: 166-153. Unpublished study prepared by Wildlife
International Ltd. 201 p.
42058300 Sumitomo Chemical America, Inc. (1991) Submission of toxicity data in
support of the Fenitrothion data call-in of April 29, 1986. Transmittal of 1
study.
42058301 Suetake, K. (1991) 21-Day Toxicity Study in Rabbits with Sumithion T.G.:
Final Report: Lab Project Number: 29022. Unpublished study prepared by
Panapharm Laboratories Co., Ltd. 177 p.
42507700 Sumitomo Chemical America, Inc. (1992) Submission of supplemental product
chemistry and toxicity data to support FENITROTHION registration standard.
Transmittal of 4 studies.
42507701 Yamane, S. (1989) Storage Stability of Sumithion Technical Grade:
HP-90-0105: Lab Project Number: 8425: 8426. Unpublished study prepared
by Sumitomo Chemical Co. , Ltd. 7 p.
42507702 Yamamoto, S. (1989) Homogeneity and Concentration Analysis of Sumithion in
Feed: HP-91-0487: Lab Project Number: 8425: 8426: 5906. Unpublished
study prepared by Sumika Chemical Analysis Service, Ltd. 30 p.
42507703 Kobayashi, A. (1992) Stability Analysis of Sumithion in Feed: HP-21-0498:
Lab Project Number: 8425: 8426: 5909. Unpublished study prepared by
Sumika Chemical Analysis Service, Ltd. 14 p.
42507704 Tamano, S. (1992) Comment on the EPA's Review of the Mouse Conbined
Chronic Toxicity and Oncogenicity Study (Sumithion Technical): Supplemental
Report (MRID 41925201): Lab Project Number: 8425: 8426. Unpublished
study prepared by Daiyu-kai Institute of Medical Science. 9 p.
94
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BIBLIOGRAPHY
MRID
CITATION
42632300 Sumitomo Chemical America, Inc. (1993) Submission of product chemistry
data in support of the registration standard for Fenitrothion. Transmittal of 1
study.
42632301 Furuta, R. (1988) Determination of Viscosity of Sumithion Technical Grade:
Lab Project Number: HP-81-0106. Unpublished study prepared by Sumitomo
Chemical Co., Ltd. 6 p.
42632400 Sumitomo Chemical America, Inc. (1993) Submission of product chemistry
data in support of the registration standard for fenitrothion. Transmittal of 1
study.
42632401 Numashima. (1988) Results of the Test of Physical Properties of the Film
Coated on the Drums for Sumithion: Lab Project Number: HP-81-0107:
757-88-101. Unpublished study prepared by Sumitomo Chemical America,
Inc. 15 p.
42668800 Sumitomo Chemical Co. (1993) Supplemental submission of toxicity data in
support of the Fenitrothion registration standard. Transmittal of 1 study.
42668801 Hoberman, A. (1993) Reproductive Effects of Sumithion Administered Orally
in Feed to Crl:DC (SD) BR Rats for Two Generations—Addendum: Lab Project
Number: 1119-008: HT-31-0513: 1-0285. Unpublished study prepared by
Argus Research Labs., Inc. 62 p.
42815800 Sumitomo Chemical America, Inc. (1993) Submission of product chemistry
data in response to EPA's review of Sumithion Technical CSF. Transmittal of
1 study.
42815801 Weintraub, P. (1993) Comments on EPA's Review of Sumithion Technical
Confidential Statement of Formula. Unpublished study prepared by Sumitomo
Chemical America, Inc. 9 p.
95
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APPENDIX D. List of Available Related Documents
The following is a list of available documents related to Fenitrothion. 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 Fenitrothion 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. Fenitrothion RED Fact Sheet (included in Appendix G)
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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98
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APPENDIX E. PR Notices 86-5 and 91-2
99
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100
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PR Notice 86-5
101
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102
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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
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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
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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
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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
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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)
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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
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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
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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".
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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
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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
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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)
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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.
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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.
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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)
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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
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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
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PR Notice 91-2
119
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120
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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
121
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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)
123
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APPENDIX F. Combined Generic and Product Specific
Data Call-In
125
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126
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
0
f WASHINGTON, D.C. 20460
GENERIC AND PRODUCT SPECIFIC
DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires 7911 and other registrants of pesticide
products containing the active ingredient identified in
Attachment A of this N9tice, 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 (£9^ both
generic and pr9duct specific data), the Requirements
Status and Registrant's Response Form, (see section
III-B); or
3 . Why you believe EPA should rupt 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 t9 this Notice will be subject t9 suspensi9n.
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 secti9n 3(c)(2)(B) of the
Federal Insecticide, Fungicide and Rodenticide Act as amended
(FIFRA) , 7 U.S.C. section 136a (c) (2) (B) . Collection of. this
information is authorized under the Paperwork Reduction Act by
OMB Approval No. 2070-0107 and 2070-0057 (expiration date
3-31-96).
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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
Unreas9nable Adverse Effects
Section VI - Inquiries and Responses to this Notice
The Attachments to this Notice are:
I - Data Call-In Chemical Status Sheet
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 - 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 - 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 registrati9n of the subject active ingredient(s). This
reevaluation identified additional data necessary to assess the
health and safety 9f 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 b9th 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 C9nducted 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 Informati9n Service (NTIS), Attn: Order Desk, 5285 Port
Royal Road, Springfield, Va 22161 (Telephone number:
703-487-4650).
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Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if the
OECD recommended test standards conform to those specified in the
Pesticide Data Requirements regulation (40 CFR § 158.70). When
using the OECD protocols, they should be modified as appropriate
so that the data generated by the study will satisfy the
requirements of 40 CFR § 158. Normally, the Agency will not
extend deadlines for complying with data requirements when the
studies were not conducted in accordance with acceptable
standards. The OECD protocols are available from OECD, 2001 L
Street, N.W., Washington, D.C. 20036 (Telephone number 202-785-
6323; Fax telephone number 202-785-0350).
All new studies and proposed protocols submitted in response
to this Data Call-in Notice must be in accordance with Good
Laboratory Practices [40 CFR Part 160] .
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B)
NOTICES ISSUED 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 N9tices 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 resp9nse to this Notice. The type of Data Call-
in y9u must C9mply 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 9f 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 N9tice for generic data
requirements are: (a) voluntary cancellation, (b) delete use(s),
(c) claim generic data exemption, (d) agree t9 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 9pti9n, 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-Call-in Response
Form, and the Requirements Status and Registrant's Response Form,
(contained in Attachments 2 and 3, respectively).
The Data Call-in Resp9nse Forms must be submitted as part of
every response to this Notice. The Requirements Status and
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Registrant's Response Forms also must be submitted if y9u do not
qualify for a Generic Data Exempti9n or are not requesting
voluntary cancellati9n of your registration(s). Please note that
the company's authorized representative is required to sign the
first page of both Data Call-in Response Forms and the
Requirements Status and Registrant's Response Forms (if this form
is required) and initial any subsequent pages. The forms contain
separate detailed instructions on the response options. Do not
alter the printed material. If you have questions or need
assistance in preparing your response, call or write the contact
person(s) identified in Attachment 1.
a. Voluntary Cancellation -
You may avoid the requirements of this Notice by requesting
voluntary cancellation of your product(s) containing the active
ingredient that is the subject of this Notice. If you wish to
voluntarily cancel your product, you must submit completed
Generic and Product Specific Data Call-In Resp9nse F9rms
(Attachment 2), indicating your election of this option.
Voluntary cancellation is item number 5 9n 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 ch9se to voluntarily cancel your product, further
sale and distribution of your product after the effective date of
cancellation must be in accordance with the Existing Stocks
provisions of this Notice, which are contained in Section IV-C.
b. Use Deletion -
You may avoid the requirements of this Notice by eliminating
the uses of your product to which the requirements apply. If you
wish to amend your registration to delete uses, you must submit
the Requirements Status and Registrant's Response Form
(Attachment 3), a completed application for amendment, a copy of
your proposed amended labeling, and all other informati9n
required for pr9cessing the applicati9n. Use deletion is option
number 7 under item 9 in the instructions for the Requirements
Status and Registrant's Response F9rms. You must als9 complete a
Data Call-In Response Form by signing the certification, item
number 8. Application forms for amending registrations may be
obtained from the Registration Support Branch, Registration
Division, Office of Pesticide Programs, EPA, by calling (703)
308-8358.
If you choose t9 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 pr9duct is exempt from the requirement to
submit 9r cite generic data concerning an active ingredient if
the active ingredient in the product is derived exclusively from
purchased, registered pesticide products C9ntaining 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;
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(ii). Every registrant who is the ultimate source of the
active ingredient in your product subject to this DCI must
be in compliance with the requirements of this Notice and
must remain in compliance; and
(iii). You must have provided to EPA an accurate and
current "Confidential Statement of Formula" for each of your
products to which this Notice applies.
To apply for the Generic Data Exemption you must submit a
completed Data Call-in Response Form, Attachment 2 and all
supporting documentation. The Generic Data Exemption is item
number 6a on the Data Call-in Response Form. If you claim a
generic data exemption you are not required to complete the
Requirements Status and Registrant's Response Form. Generic Data
Exemption cannot be selected as an option for responding to
product specific data requirements.
If you are granted a Generic Data Exemption, you rely on the
efforts of other persons to provide the Agency with the required
data. If the registrant(s) 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 registrati9ns 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 9ptions available to satisfy the generic
data requirements of this Notice. These options are discussed in
Section III-C.l. 9f this Notice and comprise options 1 through 6
of item 9 in the instructions f9r 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 well 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
Resp9nse 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) V9luntary 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 discussi9n 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
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Response Form, for product specific data (contained in
Attachments 2 and 3, respectively) . The Data Call -In Response
Form must be submitted as part of every response to this Notice.
In addition, one copy of the Requirements Status and Registrant's
Response Form also must be submitted for each product listed 9n
the Data Call-in Response Form unless 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 5 on both the Generic and
Product Specific Data Call -In Response Forms. If you choose this
option, you must complete both Data Call-in response forms.
These are the only forms that you are required to complete.
If you ch9ose 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 9ptions
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
opti9n are not valid options for fulfilling product specific data
requirements. It is important to ensure that you are using the
correct f9rms and instructi9ns when completing your response to
the Reregistration Eligibility Decision document.
c . Request for Product Specific Data Waivers .
Waivers f9r product specific data are discussed in Section
III-D.2. of this Notice and are covered by option 7 9f item 9 in
the instructions for the Requirements Status and Registrant's
Response Form. If you choose this opti9n, 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
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requirement. Y9ur option selection should be entered under item
number 9, "Registrant Resp9nse." 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 F9rm. 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)
(3) I have made 9ffers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been
submitted previously to the Agency by anyone
(Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study
classified by EPA as partially acceptable and
upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified
as acceptable or an existing study that has been
submitted but not reviewed by the Agency (Citing an
Existing Study)
Option 1. Developing Data
If you choose to develop the required data it must be in
conf9rmance 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 Lab9ratory
Practice (GLP) rule (40 CFR Part 160), be conducted according to
the Pesticide Assessment Guidelines (PAG) and be in conformance
with the requirements of PR Notice 86-5. In additi9n, certain
studies require Agency approval of test protocols in advance of
study initiation. Th9se 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 Secti9n 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 pr9tocol 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 39016 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 pr9gress report must
include the date the study was or will be initiated and, for
studies to be started within 12 months of C9mmitment, 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
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registrant is subject to receipt of a Notice of Intent to Suspend
the affected registration(s).
If y9u cannot submit the data/reports to the Agency in the
time required by this Notice and intend to seek additional time
to meet the requirements(s), you must submit a request to the
Agency which includes: (1) a detailed description of the expected
difficulty and (2) a proposed schedule including alternative
dates for meeting such requirements on a step-by-step basis. Y9u
must explain any technical or laboratory difficulties and provide
documentati9n 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 ch9ose 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
t9 produce the data need not specify all of the terms of the
final arrangement between the parties or the mechanism to resolve
the terms. Section 3(c)(2)(B) provides that if the parties cannot
resolve the terms of the agreement they may resolve their
differences through binding arbitration.
Option 3. Offer to Share in the Cost of Data Development
If you have made an offer to pay in an attempt to enter into
an agreement or amend an existing agreement to meet the
requirements of this N9tice and have been unsuccessful, you may
request EPA (by selecting this option) to exercise its discretion
not to suspend your registration(s), although you do not comply
with the data submission requirements of this Notice. EPA has
determined that as a general policy, absent other relevant
considerations, it will not suspend the registration of a product
of a registrant who has in good faith sought and continues to
seek to enter into a joint data development/cost sharing program,
but the other registrant(s) developing the data has refused to
accept 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 arbitrati9n as provided by FIFRA secti9n 3(c)(2)(B)(iii)
and must not qualify this offer. The other registrant must also
inform EPA of its election of an option to develop and submit the
data required by this Notice by submitting a Data Call-In
Response Form and a Requirements Status and Registrant's Resp9nse
Form committing to develop and submit the data"required by this
Notice.
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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 t9 develop the data 9r 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 9r
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) .
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 submissi9n. The Agency may determine at any time that a
study is not valid and needs to be repeated.
To meet the requirements of the DCI Notice f9r submitting an
existing study, all of the following three criteria must be
clearly Met :
a. You must certify at the time that the existing study is
submitted that the raw data and specimens from the
study are available for audit and review and you must
identify where they are available. This must be done in
accordance with the requirements of the Good Laboratory
Practice (GLP) regulation, 40 CFR Part 160. As stated
in 40 CFR 160.3 'Raw data' means any laboratory
worksheets, records, memoranda, notes, or exact C9pies
thereof, that are the result of original observations
and activities of a study and are necessary for the
reconstruction and evaluation of the report of that
study. In the event that exact transcripts of raw data
have been prepared (e.g., tapes which have been
transcribed verbatim, dated, and verified accurate by
signature) , the exact copy or exact transcript may be
substituted for the original source as raw data. 'Raw
data' may include photographs, microfilm or microfiche
C9pies, 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 als9 contain all GLP-required quality assurance
and quality control information, pursuant to the
requirements of 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
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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 protoc9ls. 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 prot9col 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 y9u know of a study pertaining to any requirement in this
Notice which does not meet the criteria outlined above but does
contain factual information regarding unreasonable adverse
effects, you must notify the Agency of such a study. If such
study is in the Agency's files, you need only cite it along with
the notification. If not in the Agency's files, you must submit a
summary and copies as required by PR Notice 86-5.
Option 5. Upgrading a Study
If a study has been classified as partially acceptable and
upgradeable, you may submit data to upgrade that study. The
Agency will review the data submitted and determine if the
requirement is satisfied. If the Agency decides the requirement
is not satisfied, you may still be required to submit new data
normally without any time extension. Deficient, but upgradeable
studies will normally be classified as supplemental. However, it
is important to note that not all studies classified as
supplemental are upgradeable. If you have questions regarding the
classification of a study or whether a study may be upgraded,
call or write the contact person listed in Attachment 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) 9f 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 number of the study being
upgraded.
The criteria for submitting an existing study, as specified
in Option 4 above, apply to all data submissions intended to
upgrade studies. Additionally, your submission of data intended
to upgrade studies must be accompanied by a certification that
you comply with each of those criteria, as well as a
certification regarding protocol compliance with Agency
requirements.
Option 6. Citing Existing Studies
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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 toxicol9gy 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 opti9n, 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 y9u 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
Resp9nse Form that you agree to satisfy the product specific data
requirements (i.e. you select option 7a or 7b), then you must
select one of the six options on the Requirements Status and
Registrant's Response Form related t9 data production for each
data requirement. Y9ur option selection should be entered under
item number 9, "Registrant Resp9nse." The six options related to
data pr9duction are the first six options discussed under item 9
in the instructions for completing the Requirements Status and
Registrant's Response F9rm. These six options are listed
immediately below with inf9rmation 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 rrrare
registrants to develop data jointly (Cost Sharing)
(3) I have made 9ffers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been
submitted previously to the Agency by anyone
(Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study
classified by EPA as partially acceptable and
upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified
as acceptable or an existing study that has been
submitted but not reviewed by the Agency (Citing an
Existing Study)
Option 1. Developing Data -- 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
Sroduct specific data as to generic data (see Section III.C.I,
ption 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 pr9ducts in the group. The registration number of
the product for which data will be submitted must be n9ted 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 III.C.I., Option 3)
apply to this option. This option 9nly applies to acute toxicity
and certain efficacy data as described in option 2 above.
Option 4. Submitting an Existing Study -- The same requirements
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described for generic data (see Section III.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 III.C.l., Option 5) apply to this
option for product specific data.
Option 6 . Citing Existing Studies -- The same requirements
described for generic data (see Section III.C.l., Option 6) apply
to this option for product specific data.
Registrants who select one of the ab9ve 6 options must meet
all of the requirements described in the instructions for
completing the Data Call -In Response Form and the Requirements
Status and Registrant's Response Form, and in the generic data
requirements section (III.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
econ9mic incentive to conduct the testing, the importance of the
pesticide, and the exposure and risk from use of the pesticide.
If an active ingredient is used for b9th 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 conditi9n of the waiver, to
submit annual sales reports. The Agency will respond to requests
for waivers in writing.
To apply for a l9w volume, minor use waiver, you must
submit the following information, as applicable t9 your
product(s), as part of your 90-day response to this Notice:
(i) . Total company sales (pounds and d9llars) of all
registered product (s) containing the active ingredient. If
applicable to the active ingredient, include foreign sales
for those pr9ducts 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 manor 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
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years. Include inf9rmation 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 9f 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 C9mpany sales (pounds and dollars) of the active
ingredient, direct production costs of product(s) C9ntaining
the active ingredient (f9llowing the parameters in item 2
above), indirect production C9sts of product(s) containing
the active ingredient (following the parameters in item 3
above), and C9sts of data development pertaining to the
active ingredient.
(viii) A description of the importance and unique
benefits of the active ingredient to users. Discuss the use
patterns and the effectiveness 9f 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 t9 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 y9ur 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
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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), y9u must cho9se a method of meeting the
requirements of this Notice within the time frame provid'ed
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
opti9n 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 for product chemistry,
acute toxicity and efficacy (where appropriate) are required
for all products and the Agency would grant a waiver only
under extraordinary circumstances. You should als9 be aware
that submitting a waiver request will not automatically
extend the due date for the study in questi9n. Waiver
requests submitted without adequate supporting rationale
will be denied and the original due date will remain in
force.
SECTION IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent t9 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 t9 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).
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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 Registrant'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.
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 inc9rporated 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 9f 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 supp9rting (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.
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The Agency has determined that such dispositi9n 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 C9nsistent 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 n9t C9nsider
any request pertaining to the continued sale, distribution, or
use of your existing stocks after suspension.
If you request a voluntary cancellation of y9ur 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 distribut9rs, retailers and end
users to sell, distribute or use such existing stocks until the
stocks are exhausted. Any sale, distribution or use 9f 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 n9t result in
the agency granting any additional time to sell, distribute, or
use existing stocks beyond a year from the date the 90 day
resp9nse was due, unless you demonstrate to the Agency that you
are in full compliance with all Agency requirements, including
the requirements of this Notice. For example, if you decide to
voluntarily cancel your registration six months before a 3-year
study is scheduled to be submitted, all progress reports and
other information necessary to establish that you have been
conducting the study in an acceptable and good faith manner must
have been submitted to the Agency, before EPA will consider
granting an existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(2) states
that if at any time after a pesticide is registered a registrant
has additional factual information regarding unreasonable adverse
effects on the environment by the pesticide, the registrant shall
submit the information to the Agency. Registrants must notify the
Agency of any factual information they have, from whatever
source, including but not limited to interim or preliminary
results of studies, regarding unreasonable adverse effects on man
or the environment. This requirement continues as long as the
products are registered by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and
procedures established by this Notice, call the contact person(s)
listed in Attachment 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
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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,
/s/
Lois A. Rossi, Director
Special Review and
Reregistration Division
Attachments
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2 - Generic Data Call-In and Product Specific Data Call-In
Response Forms with Instructions
3 - Generic Data Call-In and Pr9duct 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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Fenitrothion DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Call-in Notice because
you have product(s) containing Fenitrothion.
This Generic Data Call-In Chemical Status Sheet, contains an
overview of data required by this notice, and point of contact
for inquiries pertaining to the reregistration of Fenitrothion.
This attachment is to be used in C9njunction 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 Fenitrothion 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 Fenitr9thion are contained in the
Requirements Status and Registrant's Response, Attachment C. The
Agency has concluded that additional product chemistry data on
Fenitrothion are needed. These data are needed to fully complete
the reregistration of all eligible Fenitrothion 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 Dennis McNeilly at (703) 308-8066.
All responses to this Notice for the generic data
requirements should be submitted to:
Dennis McNeilly, Chemical Review Manager
Reregistration Branch
Special Review and Registration Division (H7508W)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washingt9n, D.C. 20460
RE: Fenitrothion
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FENITROTHION DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-in Notice
because you have product(s) containing Fenitrothion.
This Product Specific Data Call-In Chemical Status Sheet,
contains an overview of data required by this notice, and point
of contact for inquiries pertaining to the reregistration of
Fenitrothion. 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 Toxic9logy
Data Requirement (Attachment 4) , (5) the EPA Acceptance Criteria
(Attachment 5), (6) a list of registrants receiving this DCI
(Attachment 6) and (7) the Cost Share and Data Compensation Forms
in replying to this Fenitrothion 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 Fenitrothion are contained in the Requirements
Status and Registrant's Response, Attachment 3. The Agency has
concluded that additional data on Fenitrothion are needed for
specific pr9ducts. 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 Fenitrothion
products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If y9u have any questions regarding the generic database of
Fenitrothion, please contact Dennis McNeilly at (703) 308-8066.
If y9u have any questions regarding the product specific
data requirements and procedures established by this Notice,
please contact Moana Appleyard at (703) 308-8175.
All responses to this Notice for the Product Specific data
requirements should be submitted to:
Moana Appleyard
Chemical Review Manager
Product Reregistration Branch
Special Review and Reregistration Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Fenitrothion
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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 Reregistrati9n 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.
Alth9ugh 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 devel9ped 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 f9r 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 omissi9n to the Agency's attention
within the period required for submission of this response form.
Item 5. ON BOTH FORMS: Check this item f9r 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 9f 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 6 a. ON THE GENERIC DATA FORM: Check this Item if the Data
Call-in is for generic data as indicated in Item 3 and y9u 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 pr9duct from one or
more other pr9ducers (who, with respect to the incorporated
product, are in compliance with this and any other outstanding
Data Call-in Notice) , and
INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call -In
incorporate that product int9 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 39016 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
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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 Va.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 7b.For each end use product (EUP) for which you wish to
maintain registration, you must agree to satisfy the data
requirements by responding "yes."
FOR BOTH MUP and EUP products
You should also respond "yes" to this item (7a for MUP's and 7b
for EUP's) if your product is identical to another product and
you qualify for a data exemption. You must provide the EPA
registration numbers of your source(s); do not complete the
Requirements Status and Registrant's Response form. Examples of
such products include repackaged products and Special Local Needs
(Section 24c) products which are identical to federally
registered products.
If you are requesting a data waiver, answer "yes" here; in
addition, on the "Requirements Status and Registrant's Response"
form under Item 9, you must respond with option 7 (Waiver
Request) for each study for which you are requesting a waiver.
NOTE: Item 7a and 7b are not applicable for Generic Data.
INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-In
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 y9ur 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
"Requirements Status and Registrant's Response Forms"
For The Generic and Product Specific Data Call-in
INTRODUCTION
These instructions apply to the Generic and Product Specific
"Requirements Status and Registrant's Resp9nse Forms" and are t9
be used by registrants to respond to generic and product specific
Data Call-in's as part of EPA's reregistrati9n program under the
Federal Insecticide, Fungicide, and R9denticide Act. The type of
Data Call-In (generic or product specific) is indicated in item
number 3 ("Date and Type of DCI") on each form. Both
"Requirements Status and Registrant's Response" forms must be
completed.
Although the form is the same for both product specific and
generic data, instructions for completing the forms differ
slightly. Specifically, 9ptions for satisfying product specific
data requirements do not include (1) deletion of uses or (2)
request for a low volume/minor use waiver. Please read these
instructions carefully before filling out the forms.
EPA has developed these forms individually for each
registrant, and has preprinted these forms to include certain
information unique to this chemical. DO NOT use these forms for
any other active ingredient.
Items 1 through 8 have been preprinted on the form. Item 9
must be completed by the registrant as appropriate. Items 10
through 13 must be completed by the registrant before submitting
a response to the Agency.
The public reporting burden for this collection of
information is estimated to average 30 minutes per resp9nse,
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 Protecti9n Agency, 401 M St., S.W.,
Washington, D.C. 20460; and to the Office of Management and
Budget, Paperwork Reduction Project 2070-0107, Washington, D.C.
20503.
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-In
Item 1. ON BOTH FORMS: This item identifies your company name,
number and address.
Item 2. ON THE GENERIC DATA FORM: This item identifies the
case number, case name, EPA chemical number and
chemical name.
ON THE PRODUCT SPECIFIC DATA FORM: This item
identifies the case number, case name, and the EPA
Registrati9n Number of the product for which the Agency
is requesting product specific data.
Item 3. ON THE GENERIC DATA FORM: This item identifies the
type of Data Call-in. The date of issuance is date
stamped.
ON THE PRODUCT SPECIFIC DATA FORM: This item
identifies the type of Data Call-in. The date of
issuance is also date stamped. Note the unique
identifier number (ID#) assigned by the Agency. This
ID number must be used in the transmittal document for
any data submissions in response to this Data Call-in
Notice.
Item 4. ON BOTH FORMS: This item identifies the guideline
reference number of studies required. These
guidelines, in addition to the requirements specified
in the Data Call-in Notice, govern the conduct of the
required studies. Note that series 61 and 62 in
product chemistry are now listed under 40 CFR 158.155
through 158.180, Subpart c.
Item 5. ON BOTH FORMS: This item identifies the study title
associated with the guideline reference number and
whether protocols and 1, 2, or 3-year progress reports
are required to be submitted in connection with the
study. As noted in Section III of the Data Call-in
Notice, 90-day progress reports are required for all
studies.
If an asterisk appears in Item 5, EPA has attached
information relevant to this guideline reference number
to the Requirements Status and Registrant's Response
Form.
INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-In
Item 6. ON BOTH FORMS: This item identifies the code
associated with the use pattern of the pesticide. In
the case of efficacy data (product specific
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requirement), the required study only pertains to
products which have the use sites and/or pests
indicated. A brief description of each code follows:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food 9utdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food crop
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
0 Indoor residential
Item 7. ON BOTH FORMS: This item identifies the code assigned
to the substance that must be used for testing. A brief
description of each code follows:
EUP End-Use Pr9duct
MP Manufacturing-Use Product
MP/TGAI Manufacturing-Use Product and Technical
Grade Active Ingredient
PAI Pure Active Ingredient
PAI/M Pure Active Ingredient and Metabolites
PAI/PAIRA Pure Active Ingredient or Pute Active
Ingredient Radiolabelled
PAIRA Pure Active Ingredient Radiolabelled
PAIRA/M Pure Active Ingredient Radiolabelled and
Metabolites
PAIRA/PM Pure Active Ingredient Radiolabelled and
Plant Metabolites
TEP Typical End-Use Product
TEP % Typical End-Use Product, Percent Active
Ingredient Specified
TEP/MET Typical End-Use Product and Metabolites
TEP/PAI/M Typical End-Use Product or Pure Active
Ingredient and Metabolites
TGAI Technical Grade Active Ingredient
TGAI/PAI Technical Grade Active Ingredient or
Pure Active Ingredient
TGAI/PAIRA Technical Grade Active Ingredient or
Pure Active Ingredient Radi9labelled
TGAI/TEP Technical Grade Active Ingredient or
Typical End-Use Product
MET Metab9lites
IMP Impurities
DEGR Degradates
* See: guideline comment
Item 8. This item completed by the Agency identifies the time
frame allowed for submission of the study or protocol
identified in item 5.
ON THE GENERIC DATA FORM: The time frame runs from the
date of your receipt of the Data Call-in notice.
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ON THE PRODUCT SPECIFIC DATA FORM: The due date for
submission of product specific studies begins from the
date stamped on the letter transmitting the
Reregistration Eligibility Decision document, and not
from the date of receipt. However, your response to
the Data Call-in itself is due 90 days from the date of
receipt.
Item 9. ON BOTH FORMS: Enter the appropriate Response Code or
Codes to show h9w you intend to comply with each data
requirement. Brief descriptions of each code follow.
The Data Call-in Notice contains a fuller description
of each of these options.
Option 1. ON BOTH FORMS: (Developing Data) I will conduct a
new study and submit it within the time frames
specified in item 8 above. By indicating that I
have chosen this option, I certify that I will
comply with all the requirements pertaining to the
conditions for submittal of this study as outlined
in the Data Call-in Notice and that I will provide
the protocols and progress reports required in
item 5 above.
Option 2. ON BOTH FORMS: (Agreement to Cost Share) I have
entered into an agreement with one or more
registrants to develop data jointly. By indicating
that I have chosen this option, I certify that I
will comply with all the requirements pertaining
to sharing in the cost of developing data as
outlined in the Data Call-in Notice.
However, for Product Specific Data, I
understand that this option is available for acute
toxicity or certain efficacy data ONLY if the
Agency indicates in an attachment to this notice
that my product is similar enough to another
product to qualify for this option. I certify that
another party in the agreement is committing to
submit or provide the required data; if the
required study is not submitted on time, my
product may be subject to suspension.
Option 3. ON BOTH FORMS: (Offer to Cost Share) I have made
an offer to enter into an agreement with one or
more registrants to develop data jointly. I am
also submitting a completed "Certification of
offer to Cost Share in the Development of Data"
form. I am submitting evidence that I have made
an 9ffer to another registrant (who has an
obligation to submit data) to share in the cost of
that data. I am including a copy of my offer and
proof of the other registrant's receipt of that
offer. I am identifying the party which is
committing to submit or provide the required data;
if the required study is not submitted on time, my
product may be subject to suspension. I understand
that other terms under Option 3 in the Data
Call-in Notice apply as well.
However, for Product Specific Data, I
understand that this option is available only for
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acute toxicity or certain efficacy data and only
if the Agency indicates in an attachment t9 this
Data Call-in Notice that my product is similar
enough to another product to qualify for this
option.
Option 4. ON BOTH FORMS: (Submitting Existing Data) I will
submit an existing study by the specified due date
that has never before been submitted t9 EPA. By
indicating that I have chosen this option, I
certify that this study meets all the requirements
pertaining to the conditions for submittal of
existing data outlined in the Data Call-in Notice
and I have attached the needed supporting
information along with this response.
Option 5. ON BOTH FORMS: (Upgrading a Study) I will submit
by the specified due date~or will cite data to
upgrade a study that EPA has classified as
partially acceptable and potentially upgradeable.
By indicating that I have chosen this option, I
certify that I have met all the requirements
pertaining to the conditions for submitting or
citing existing data to upgrade a study described
in the Data Call-in Notice. I am indicating on
attached correspondence the Master Record
Identification Number (MRID) that EPA has assigned
to the data that I am citing as well as the MRID
of the study I am attempting to upgrade.
Option 6. ON BOTH FORMS: (Citing a Study) I am citing an
existing study that has been previously classified
by EPA as acceptable, core, core minimum, or a
study that has not yet been reviewed by the
Agency. If reviewed, I am providing the Agency's
classification of the study.
However, for Product Specific Data, I am
citing another registrant's study. I understand
that this option is available ONLY for acute
toxicity or certain efficacy data and ONLY if the
cited study was conducted on my product, an
identical product or a product which the Agency
has "grouped" with one or more other products for
purposes of depending on the same data. I may also
choose this option if I am citing my own data. In
either case, I will provide the MRID or Accession
number (s). If I cite another registrant's data,
I will submit a completed "Certification With
Respect To Data Compensation Requirements" form.
FOR THE GENERIC DATA FORM ONLY; The following three options
(Numbers 7, 8, and 9) are responses that apply only to the
"Requirements Status and Registrant's Response Form" for
generic data.
Option 7. (Deleting Uses) I am attaching an application for
amendment to my registration deleting the uses for
which the data are required.
Option 8. (Low Volume/Minor Use Waiver Request) I have read
the statements concerning low volume-minor use
161
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data waivers in the Data Call-in Notice and I
request a low-volume min9r use waiver of the data
requirement. I am attaching a detailed
justification to support this waiver request
including, among other things, all information
required to support the request. I understand
that, unless modified by the Agency in writing,
the data requirement as stated in the Notice
governs.
Option 9. (Request for Waiver of Data) I have read the
statements concerning data waivers other than low-
volume minor-use data waivers in the Data Call-in
Notice and I request a waiver of the data
requirement. I am attaching a rationale explaining
why I believe the data requirements do not apply.
I am also submitting a copy of my current labels.
(You must also submit a copy of your Confidential
Statement of Formula if not already on file with
EPA). I understand that, unless modified by the
Agency in writing, the data requirement as stated
in the Notice governs.
FOR PRODUCT SPECIFIC DATA; The following option (number 7)
is a response that applies to the "Requirements Status and
Registrant's Response Form" for product specific data.
Option 7. (Waiver Request) I request a waiver for this
study because it is inappropriate for my product.
I am attaching a complete justification for this
request, including technical reasons, data and
references to relevant EPA regulations, guidelines
or policies. [Note: any supplemental data must be
submitted in the format required by P.R. Notice
86-5] . I understand that this is my only
9pportunity to state the reasons or provide
information in support of my request. If the
Agency approves my waiver request, I will not be
required to supply the data pursuant to Section
3(c) (2) (B) of FIFRA. If the Agency denies my
waiver request, I must choose a method of meeting
the data requirements of this Notice by the due
date stated by this Notice. In this case, I must,
within 30 days-of my receipt of the Agency's
written decision, submit a revised "Requirements
Status" form specifying the option cl^sen. I also
understand that the deadline for submission of
data as specified by the original Data Call-in
notice will not change.
Item 10. ON BOTH FORMS: This item must be signed by an
auth9rized representative of y9ur company. The person
signing must include his/her title, and must initial
and date all other pages of this form.
Item 11. ON BOTH FORMS: Enter the date of signature.
Item 12. ON BOTH FORMS: Enter the name of the person EPA should
contact with questions regarding your response.
Item 13. ON BOTH FORMS: Enter the phone number of your company
contact.
162
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NOTE: You may provide additional information that does not fit on this form in a signed letter that accompanies this your response. For example, you
may wish to report that your product has already been transferred to another company or that you have already voluntarily cancelled this
163
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164
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Attachment 4. EPA Batching of End-Use
Products for Meeting Data Requirements for
Reregistration
165
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166
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EPA'S BATCHING OF FENITROTHION PRODUCTS FOR MEETING ACUTE TOXICITY
DATA REQUIREMENTS FOR REREGISTRATION
In an effort to reduce the time, resources and number of
animals needed to fulfill the acute toxicity data requirements for
reregistration of products containing fenitr9thion as the active
ingredient, the Agency has batched products which can be considered
similar for purposes of acute toxicity. Factors considered in the
sorting process include each product's active and inert ingredients
(identity, percent composition and biological activity), type of
formulation (e.g., emulsifiable concentrate, aerosol, wettable
powder, granular, etc.), and labeling (e.g., signal word, use
classification, precautionary labeling, etc.). Note that the
Agency is not describing batched products as "substantially
similar" since some products within a batch may not be considered
chemically similar or have identical use patterns.
Using available information, batching has been accomplished by
the process described in the preceding paragraph. Notwitn-standing
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 toxicological studies to represent all the products within
that batch. It is the registrants' option to participate in the
process with all other registrants, only some of the other
registrants, or only their own products within a batch, or to
generate all the required acute toxicological studies for each of
their own products. If a registrant chooses to generate the data
for a batch, he/she must use one of the products within the batch
as the test material. If a registrant chooses to rely upon
previously submitted acute toxicity data, he/she may do so provided
that the data base is complete and valid by today's standards (see
acceptance criteria attached), the f9rmulation tested is considered
by EPA to be similar for acute toxicity, and the formulation has
not been significantly altered since submission and acceptance 9f
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 9f 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 dTata 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 9f 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),
167
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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.
Six products were found which contain fenitrothion as the
active ingredient. The products have been placed int9 two batches
and a "no batch" category in accordance with the active and inert
ingredients, type of formulation and current labeling. Table 1
identifies the products in each batch. Table 2 lists the products
which have been placed in the "no batch" category.
Table 1
Batch
1
2
EPA Reg. No.
506-174
506-175
2217-715
39398-13
% Active Ingredient
Fenitrothion 0.015
Fenitrothion 1 . 0
Fenitrothion 76.8
Fenitrothion 73.06
Formulation
Type
Solid
Solid
Liq
Liq
The following table lists products that were either considered
not t9 be similar or the Agency lacked sufficient information for
decision making and were not placed in any batch. Registrants of
these products are responsible for meeting the acute toxicity data
requirements separately for each product.
Table 2 (No Batch)
EPA Reg.
No.
39398-4
2217-714
% Active Ingredient
Fenitrothion 95.0
Fenitrothion 45.0
Formulation
Type
Liq
Liq
168
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Attachment 5. EPA Acceptance Criteria
169
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170
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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
171
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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).
172
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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.
173
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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
174
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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
175
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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 supplemental and may not be required for every study.
-------
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.
-------
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.
178
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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 supplemental and may not be required for every study.
-------
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 and may not be required for every study.
-------
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 supplemental and may not be required for every study.
181
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182
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Attachment 6. List of All Registrants Sent This Data Call-In (insert) Notice
183
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184
-------
Attachment 7. Cost Share Data Compensation Forms, Confidential Statement of
Formula Form and Instructions
185
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186
-------
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188
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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.
189
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190
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?/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
-------
192
-------
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
.^ED s&ijv
^P^k '—
»?• B&JB '->
USB;
Form
Approved
OMB No.
2070-0107,
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 regardingthe burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden to, Chief Information Policy Branch PM-233 U.S. Environmental Protection
Agency, 401 ivl St., S.W., Washington, DC 20460; and to the Office of Management and Budget, Paperwork Reduction Project
(2070-dl06), Washington, DC 20503.
Please fill in blanks below.
Company Name
Product Name
Company
Number
EPA Reg. No.
I Certify that:
1 . For each study cited in support of registration or reregistratiion 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 reregistration 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)(F) and 3(c](2)(D) of FIFRA; and (b) Commence negotiation to determine which data are subject to the compensation
requirement of FlFRA and the amount of compensation due, if any. The companies I have notified are. (check one)
[ ] The companies who have submitted the studies listed on the back of this form or attached sheets, or indicated on the
attached "Requirements Status and Registrants' Response Form,"
3. That I have previously complied with section 3(c)(1)(F) of FIFRA for the studies I have cited in support of registration or
reregistration under FIFRA.
Signature
Date
Name and Title (Please Type or Print)
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons with regard to the
registration or reregistration of my products, to the extent required by FIFRA section 3(c)(1)(F) and 3(c)(2)(D).
Signature
Date
Name and Title (Please Type or Print)
EPA Form 8570-31 (4-96)
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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-95-017
July 1995
R.E.D. FACTS
Fenitrothion
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 0445, fenitrothion.
Fenitrothion is an organophosphate insecticide and acaricide used for
commercial greenhouse and outdoor use on ornamentals, including trees, to
control a variety of insects and mites. Fenitrothion also is marketed in two
new bait products used to control ants and roaches in and around homes,
stores, restaurants, warehouses, and other sites. Two mosquito control
products used in other countries (not in the U.S.) to prevent malaria are
being voluntarily cancelled by the manufacturer. No food or feed uses are
registered, however a food additive regulation is established for residues of
fenitrothion in or on wheat gluten imported from Australia.
Fenitrothion is applied to ornamentals using ground-based and hand-
held equipment. Annual usage on ornamentals is small and appears to be
decreasing. Fenitrothion formulations include a wettable powder,
emulsifiable concentrate, and bait.
Regulatory
History
Fenitrothion was first registered as a pesticide in the U.S. in 1975, for
control of the spruce budworm in forests. EPA issued a Data Call-in (DCI)
in 1984 requiring additional chronic toxicity data, and a Registration
Standard in July 1987 (PB88-191697) which evaluated the studies submitted
in response to the DCI. Certain label restrictions were necessary including
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Human Health
Assessment
a 24-hour interim reentry interval for greenhouse and nursery ornamental
uses, and restricted-use classification for the forestry uses. EPA issued a
second DCI in June 1991, and required labeling to reflect the high toxicity
to birds, honeybees, and aquatic invertebrates. Precautions were imposed to
protect endangered species. The registrant requested cancellation of the
forestry uses in 1992.
Through implementation of the labeling requirements of the 1992
Worker Protection Standard for Agricultural Pesticides (WPS), the 24-hour
interim reentry interval was converted to a 24-hour interim restricted entry
interval. Uses within the scope of the WPS include all commercial and
research uses of fenitrothion to produce agricultural plants, including use on
ornamentals. Fenitrothion ant and roach bait products, registered in January
1995, fall outside the scope of the WPS.
The Agency currently is requiring additional exposure data for
fenitrothion before it can make a regulatory decision on the eligibility of low
pressure handwand and knapsack/backpack methods of application. Six
fenitrothion products are eligible for reregistration.
Toxicity
In studies using laboratory animals, fenitrothion generally has been
shown to be of moderate to high acute toxicity. It is moderately toxic by
the acute oral and dermal routes and has been placed in Toxicity Category II
(the second highest of four categories) for this effect. It is slightly toxic for
acute eye effects and is a mild dermal irritant (Toxicity Category III).
Fenitrothion is not a skin sensitizer.
Fenitrothion is classified as a Group E carcinogen, indicating that it is
non-carcinogenic to humans. It is a cholinesterase inhibitor as indicated in
several chronic and subchronic toxicity tests performed on laboratory
animals.
Studies indicate that fenitrothion does not cause reproductive effects.
Fenitrothion is not considered to be a mammalian mutagen. Metabolism
studies indicate that fenitrothion is excreted in the urine and feces within
seven days of exposure.
A rat study did not indicate ocular toxicity. A six-month ocular study
on dogs, required by the 1991 DCI, is in reserve status until a test protocol
is developed.
Dietary Exposure
Although no food uses currently are registered, people may be
exposed to residues of fenitrothion through the diet. A food additive
regulation for fenitrothion and two of its metabolites has been established
(40 CFR 185.2200(a)) for residues in wheat gluten resulting from
postharvest application of the insecticide to stored wheat in Australia. An
acute risk to the U.S. population from consumption of Australian wheat
gluten is unlikely because gluten is mixed with flour before it is eaten.
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Since fenitrothion is not registered for use on any domestic crops, its
residues are not expected to enter the diet of food animals in the U.S..
EPA developed a U.S. consumption estimate for Australian wheat
gluten, and assessed dietary exposure and risk posed by fenitrothion residues
in that commodity. For the overall U.S. population, such exposure
represents 3% of the Reference Dose (RfD), or amount believed not to
cause adverse effects if consumed daily over a 70-year lifetime. The
exposure level of the most highly exposed subgroup, children aged 1
through 6, represents 8% of the RfD. If the food additive regulation of 30
ppm is used instead of EPA's consumption estimate, these exposure and risk
estimates are doubled to 7% of the RfD for the overall U.S. population and
15% of the RfD for children aged 1 through 6. Dietary exposure and risk
are minimal.
Occupational and Residential Exposure
Based on current use patterns, fenitrothion handlers (mixers, loaders,
and applicators) may be exposed to this pesticide during and after normal
use. Exposure to fenitrothion is most likely to occur during and after its
application to ornamentals, either outdoors or in greenhouses. The primary
route of occupational exposure is dermal. Inhalation exposure may be
acute, intermittent, or chronic.
Although most of the exposure data available were questionable, EPA
assessed worker exposure and risk to fenitrothion using the toxicological
endpoints dermal toxicity resulting from intermediate exposure, and
inhalation toxicity resulting from chronic exposure, both of which may
result in cholinesterase inhibition. Exposure estimates are based on the
assumption that fenitrothion handlers wear certain personal protective
equipment. Margins of Exposure (MOEs) are less than 100 (the margin
believed sufficiently protective) for applicators using low pressure
handwands and for mixer/loader/applicators using low-pressure or
knapsack/backpack equipment. Due to a lack of post-application exposure
data, EPA was unable to estimate exposure or risk to workers following use
of fenitrothion on ornamentals.
Because they are formulated as enclosed baits, the two fenitrothion ant
and roach control products approved in early 1995 for residential use result
in considerably less human exposure than the ornamental uses, during and
after application.
Human Risk Assessment
Based on the available toxicity studies, EPA has determined that
fenitrothion presents a potential acute health hazard. It is of moderate to
high acute toxicity and is a cholinesterase inhibitor. However, it has been
classified as non-carcinogenic to humans ("Group E"). Dietary exposure to
fenitrothion residues in wheat gluten is extremely low, and dietary risk
appears to be minimal.
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Of greater concern is the risk posed to fenitrothion handlers,
particularly mixers/loaders/applicators using low pressure handwands or
knapsack/backpack equipment to treat ornamentals. The MOEs for these
handlers are inadequate. EPA is deferring a regulatory decision for
fenitrothion products applied using these methods until chemical-specific
worker exposure studies, due within one year, are submitted. Thus, for
ornamentals, high pressure handwand treatment is the only application
method eligible for reregistration at this time.
EPA is employing a number of risk mitigation measures to protect
fenitrothion handlers. For example, the Agency is requiring "baseline"
personal protective equipment (PPE); a 48-hour restricted-entry interval
(REI) which is more stringent than the (2 4-hour) interim REI set by the
Worker Protection Standard for Agricultural Pesticides (WPS); and
upgraded PPE for early entry. The 48-hour REI is increased to 72 hours
when any fenitrothion product is used in an outdoor area where the average
rainfall is less than 25 inches per year. (See RED Risk Mitigation and
Labeling sections for more details.)
Environmental Environmental Fate Assessment
AsSGSSmGnt Fenitrothion's major routes of dissipation are biotic microbial
mediated processes to carbon dioxide and abiotic aquatic photolysis.
Fenitrothion appears to be non-mobile when applied to silty clay loam, silty
clay, and sandy loam soils. It appears to dissipate fairly rapidly with a half
life of 3 to 25 days, and does not appear to be mobile. Fenitrothion is
expected to be slightly persistent and relatively non-mobile in the soil
environment. Its metabolites also appear to degrade fairly rapidly to carbon
dioxide, and are relatively non-mobile. Residues do not leach below 0-12
inches soil depth.
Ecological Effects
Fenitrothion is highly toxic to birds on an acute basis, and causes
chronic effects (reduced egg production) in reproduction studies using
bobwhite quail. It is moderately toxic to small mammals and both cold and
warm water fish on an acute basis. However, it is highly toxic to aquatic
invertebrates, and moderately to very highly toxic to estuarine organisms.
It also is highly toxic to bees.
Ecological Effects Risk Assessment
High acute risk is expected for birds consuming grass and insects, and
high chronic risk to seed-, insect-, and grass-eating birds will occur,
following single as well as multiple applications of fenitrothion at 3 Ibs.
active ingredient (ai)/acre. Risk quotients for mammals and estuarine/
marine organisms are exceeded. High acute risk to freshwater invertebrates
is expected from a single application of fenitrothion. Honey bees exposed to
this pesticide may be adversely effected.
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To reduce these risks, the registrant has proposed numerous label
modifications for products used on ornamentals including a lower use rate, a
restriction on the maximum number of applications per year, and an
increase in the retreatment interval from one week to one month. (See Risk
Mitigation, below.)
Endangered species levels of concern (LOCs) are exceeded for acute
effects to aquatic invertebrates and in some instances to birds and wild
mammals, as well as for chronic effects to birds and aquatic invertebrates.
Limitations on the use of fenitrothion may be required in the future to
protect threatened and endangered species when the Endangered Species
Protection Program goes into effect.
Risk Mitigation To lessen the acute toxicity risks of fenitrothion, EPA, in conjunction
with the registrant, has developed and is requiring the following risk
mitigation measures.
° All fenitrothion products labeled for outdoor use must be classified as
restricted use pesticides.
° Use of fenitrothion on Christmas tree plantations, on shade trees other
than those in nurseries, and basal bark (drench) treatment are being
voluntarily deleted from product labels by the registrant. These uses pose
the greatest potential for exposure to non-target species.
° For the remaining ornamental uses, the registrant has proposed
significant label revisions to reduce ecological risk, including:
• Reduce application rate to 0.3125 Ibs./acre;
• Reduce maximum number of applications to three per year;
• Increase minimum interval between applications to one month;
• Remove broadcast application from the label, limiting use to spot
treatment only.
° Due to concerns about the high acute toxicity of fenitrothion, EPA is
establishing baseline personal protective equipment (PPE) requirements for
handlers of all end-use products, and is establishing early-entry PPE
requirements including dermal protection PPE and protective eyewear.
° Due to concerns about the post-application exposure of agricultural
workers, EPA is increasing the interim Restricted Entry Interval (REI) from
24 to 48 hours for all uses within the scope of the WPS. This REI is further
increased to 72 hours when fenitrothion products are used outdoors in areas
where the average rainfall is less than 25 inches per year. The REI will be
reassessed upon receipt and review of the chemical specific exposure data
required in the RED.
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Additional Data
Required
Product Labeling
Changes
Required
EPA is requiring the following additional generic studies for
fenitrothion to confirm its regulatory assessments and conclusions:
- Acute oral LD50 for Bobwhite Quail (3-methyl-nitrophenol);
- Terrestrial Field Dissipation;
- Chronic Toxicity to Birds (reserved);
- Six Month Ocular Toxicity Study in Dogs (reserved).
Before EPA can make a reregistration eligibility decision regarding
the low pressure handwand and knapsack/backpack methods of application,
the following studies must be submitted:
- Foliar Dissipation;
- Occupational Post-application Dermal Exposure;
- Occupational Post-application Inhalation Exposure;
- Estimation of Dermal Exposure at Outdoor Sites;
- Estimation of Inhalation Exposure at Outdoor Sites;
- Estimation of Dermal Exposure at Indoor Sites;
- Estimation of Inhalation Exposure at Indoor Sites.
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 fenitrothion end-use products must comply with EPA's current
pesticide product labeling requirements, and with the following. For a
comprehensive list of labeling requirements, please see the fenitrothion RED
document.
Restricted Use Classification
All fenitrothion products labeled for outdoor use must be classified for
restricted use, and the following statement must appear on product labels:
"Restricted Use Pesticide
Due to toxicity to fish and aquatic organisms.
For retail sale to and use only by certified applicators or persons
under their direct supervision and only for those uses covered by the
certified applicator's certification."
Changes in Rates, Uses, and Number of Applications
The following changes must be made to all ornamental end-use products:
- Restricted use classification;
- Delete Christmas tree farm and Southern Pine Bark Beetle uses;
- Delete broadcast application—all ornamental uses are limited to spot
treatments;
- Limit use rate to 0.3125 Ibs ai/acre and limit the maximum number
of applications per year to three;
- Increase the minimum interval between applications to one month;
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- Limit use on shade trees to those in nurseries and/or greenhouses;
- Limit application to high pressure handwands, low pressure
handwands, and knapsack/backpack sprayers. .
Personal Protective Equipment (PPE) Requirements
The following minimum, baseline PPE requirements pertain to both WPS
and nonWPS uses by occupational handlers:
"Applicators must wear:
- Coveralls over long-sleeved shirt and long pants;
- Chemical-resistant gloves;
- Chemical-resistant footwear plus socks;
- Chemical-resistant headgear for overhead exposure;
- Chemical-resistant apron when cleaning equipment, mixing, or
loading;
- Dust/mist filtering respirator (MSHA/NIOSH approval number
prefix TC-21Q."
Entry Restrictions
EPA is requiring the following entry restrictions for all uses within the
scope of the WPS:
"Do not enter or allow worker entry into treated areas during the
restricted entry interval (REI) of 48 hours. Each 48-hour REI is
increased to 72 hours in outdoor areas where the average rainfall is
less than 25 inches per year."
The PPE required for early entry following applications of fenitrothion is:
- Coveralls over long-sleeved shirt and long pants;
- Chemical-resistant gloves;
- Chemical-resistant footwear plus socks;
- Chemical-resistant headgear for overhead exposures; and
- Protective eyewear.
User Safety Statements
EPA is requiring the following user safety statement on all end-use products
containing fenitrothion:
User Safety Requirements:
"Discard clothing and other absorbent materials that have been
drenched or heavily contaminated with this product's concentrate. Do
not reuse them. Follow manufacturer's instructions for
cleaning/maintaining PPE. If no such instructions exist for washables,
use detergent and hot water. Keep and wash PPE separately from
other laundry."
User Safety Recommendations:
"Users should wash hands before eating, drinking, chewing gum,
using tobacco, or using the toilet."
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"Users should remove clothing immediately if pesticide gets inside.
Then wash thoroughly and put on clean clothing."
"Users should remove PPE immediately after handling this product.
Wash the outside of gloves before removing. As soon as possible,
wash thoroughly and change into clean clothing."
Environmental Hazard
The following statement is required for end-use products:
"ENVIRONMENTAL HAZARD
This pesticide is toxic to birds and aquatic invertebrates. Do not apply
directly to water or to areas where surface water is present or to
intertidal areas below the mean high water mark. Runoff may be
hazardous to aquatic organisms in neighboring areas. Do not
contaminate water when disposing of equipment washwater or
rinsate."
Regulatory
Conclusion
For More
Information
EPA has determined that products containing fenitrothion are eligible
for reregistration except products labeled for application to ornamentals
using low pressure handwand and knapsack/backpack spray equipment
(products applied using high pressure handwand equipment are eligible for
reregistration). The use of eligible fenitrothion products in accordance with
labeling and risk mitigation measures specified in this RED will not pose
unreasonable adverse effects to humans or the environment. These products
will be reregistered once the required confirmatory generic data, product
specific data, CSFs, and revised labeling are received and accepted by EPA.
EPA does not have enough information at this time to make an
eligibility decision for fenitrothion products labeled for use on ornamentals
and applied using low pressure handwand and knapsack/backpack spray
equipment. The Agency is requiring additional worker exposure studies in
order to develop a more complete data base and make a reregistration
eligibility decision regarding these uses of fenitrothion.
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for fenitrothion during a 60-day time period, as
announced in a Notice of Availability published in the Federal Register. To
obtain a copy of the RED document or to submit written comments, please
contact the Pesticide Docket, Public Response and Program Resources
Branch, Field Operations Division (7506C), Office of Pesticide Programs
(OPP), US EPA, Washington, DC 20460, telephone 703-305-
5805.
Electronic copies of the RED and this fact sheet can be downloaded
from the Pesticide Special Review and Reregistration Information System at
703-308-7224. They also are available on the Internet on EPA's gopher
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server, GOPHER.EPA. GOV, or using ftp on FTP.EPA.GOV, or using
WWW (World Wide Web) on WWW.EPA.GOV.
Printed copies of the RED and fact sheet can be obtained from EPA's
National Center for Environmental Publications and Information
(EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-0419, telephone
513-489-8190, fax 513-489-8695.
Following the comment period, the fenitrothion RED document also
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 fenitrothion RED, or reregistration of individual products containing
fenitrothion, 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 8:00 pm Eastern Standard
Time, Monday through Friday.
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