v>EPA
United States
Environmental Protection
Agency
Office of Prevention, Pesticides EPA 738-R-93-007
And Toxic Substances June 1993
(H-7508W)
Reregistration
Eligibility Document
(RED)
10, 10'-OXYBISPHENOX-
ARSINE (OBPA)
Printed on Recycled Paper
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F
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OP
PREVENTION. PESTICIDES
AND TOXC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
Enclosed is a Reregistration Eligibility Document (RED) for the pesticide active
ingredient 10,10'- Oxybisphenoxarsine, hereafter referred to as OBPA. The RED is the
Agency's evaluation of OBPA's data base, its conclusions regarding human and environmental
risks associated with the current product uses, and its decisions and conditions under which uses
and products will be eligible for reregistration. Also enclosed is the EPA RED facts and the
Pesticide Reregistration Handbook which provides instructions to registrants on how to respond
to any labeling and data requirements specified in the RED and how to reregister products.
The RED identifies outstanding product specific data requirements for end-use products
and manufacturing-use products. These requirements are listed on the Requirements Status and
Registrant's Response Form, which, along with the Data Call-In Response Form listing all of
your company's products subject to the RED, is included as an Attachment. Instructions for
completing both forms are contained in the RED package. All product specific data must be
submitted and found acceptable by the Agency before a product can be reregistered.
Generic data requirements usually will have been fulfilled prior to making a reregistration
eligibility decision. However, there may be some instances where additional generic data are
required. If generic data requirements need to be fulfilled, all registrants must complete the
appropriate Data Call-In Response Form and Requirements Status and Registrant's Response
Form. These forms are in the appendices to the RED.
The RED identifies any specific labeling requirements such as restricted use classifica-
tion, groundwater hazard statements, endangered species precautions, etc., necessary for reregis-
tration based on a review of the generic data for the active ingredient. In addition, in order to
be reregistered, all product labeling must be in compliance with format and content labeling as
described in 40 CFR §156.10 and all labeling changes imposed by Pesticide Regulation (PR)
Notices, and any label changes imposed by this RED.
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The Pesticide Reregistration Handbook contains detailed instructions for compliance with
the RED and must be followed carefully. There are several key points to remember in preparing
your response to the RED:
Within 90 Davs of Your Receipt of this Letter
1. For each product which is subject to this RED, you must complete, sign and submit
the data call-in (DCI) response forms attached to the RED [Appendix G, Attachments
B and C, has forms for product specific data]. Follow the instructions in Attachments
B and C for completing those forms and submit the forms to the appropriate address
specified in the Data Call-Ins. The DCI forms for product specific data are to be sent
to the Registration Division (use the mailing distribution code RED-RD-PM22 for
your product specific response).
2. No time extensions will be granted for submitting the 9")-day responses. If the
Agency does not receive a response for a product, it may issue a Notice of Intent to
Suspend (NOIS) for that product.
3. Any requests for data waivers or time extensions to the 8-month deadline must be
submitted as part of your 90-day response. Such requests will generally not be
considered if submitted later than the 90-day response.
Within 8 Months of the Date of this Letter
1. For each product, you must submit a completed Application for Reregistration (EPA
Form 8570-1), five copies of the label and labeling revised as specified by the RED and
in accordance with current requirements, two. completed copies of the Confidential
Statement of Formula (CSF) (EPA Form 8570-4), a completed Certification with
Respect to Citation of Data (EPA Form 8570-31), and data or references to data (see
item 2 below).
2. You must submit or cite the required product specific data as part of your commit-
ment for reregistration. For most products, you will probably be citing data which have
already been submitted to the Agency. In these cases, you must submit a list of the
studies and the corresponding EPA identifier numbers (i.e., ACCESSION or MRID
numbers). Before citing these studies, you must make sure that they meet the
Agency's current acceptance criteria (Appendix G, Attachment E). Be sure to follow
data formatting requirements in P.R. Notice 86-5. Failure to adequately comply with
the data requirements specified in this RED may result in the Notice of Intent to Suspend
your product.
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The labeling and CSF which you submit for each product must comply with P.R. Notice
91-2 (Appendix D). That Notice requires that the amount of active ingredient declared
in the ingredient statement must be stated as the nominal concentration rather than the
lower certified limit. 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).
Send your Application for Registration to the Registration Division Product Manager
22 (PM 22) who is assigned to the product, Cynthia Giles-Parker. Use the correct
address shown on page 6 of the enclosed Product Registration Handbook (Appendix
E). Note that the mailing distribution code for your response is RED-RD-PM22.
Questions on product specific data requirements and labeling (for both End-use and
Manufacturing-use products) should be directed to the Registration Division Product Manager
22 Team member for OBPA, at (703) 305 - 5540.
Any questions in regard to this RED should be directed to Venus Eagle, Chemical
Review Manager, Reregistration Branch, Special Review and Reregistration Division at
(703) 308 - 8045.
The Agency is prepared to meet with any registrants who have questions about respond-
ing to the OBPA RED. If you wish to meet with the Agency, you must contact Ms. Cynthia
Giles-Parker within two weeks of your receipt of the RED. The Agency intends to have one
combined meeting with interested registrants. If there are any requests for such a meeting, the
Agency will notify all registrants who requested a meeting of the date, location and time.
Requests for a meeting will not extend the 90-day or 8-month response deadlines.
Sincerely yours,
iel M. Barolo, Director^
Special Review and *
Reregistration Division
Enclosures
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United States
Environmental Protection
Agency
Office of Prevention, Pesticides
And Toxic Substances
(H-7508W)
EPA-738-F-93-003
June 1993
R.E.D. FACTS
10, 10'- OXYBISPHENOX-
ARSINE (OBPA)
Pesticide All pesticides sold or used in the United States must be registered by
Reregistration 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 undue hazards to human health or the environment.
When a pesticide is eligible for reregistration, EPA announces its
decision and explains why in a Reregistration Eligibility Document, or
RED. This fact sheet summarizes the information in the RED for 10, 10'-
Oxybisphenoxarsine (OBPA).
Use Profile
OBPA is a bacteriostat, disinfectant (bacteriocide/germicide) and
fungicide. It is registered to prevent the growth of microorganisms in
plastics which are fabricated into shower curtains, floor coverings, wall
coverings, coated fabrics, marine upholstery, automotive vinyl trim, vinyl
molding, tarpaulins, awnings, gaskets, weather stripping, caulking, ditch
liners and swimming pool liners. OBPA also is used as a preservative in
adhesives, coatings and specialty products, in paper and paper and plastic
products, in textiles, fibers and cordage, in carpets, and in other pesticides.
OBPA is formulated as an emulsifiable concentrate, pelleted/tableted,
soluble concentrate/liquid and ready-to-use liquid. The concentration
varies from 1 to 5 percent, based on the total weight of formulation.
Regulatory OBPA was initially registered as a pesticide in the United States in
History 1965. EPA issued a Registration Standard for OBPA in October 1981
(NTIS PB82-172271). The Registration Standard required additional
product chemistry data, a hydrolysis study and an activated sludge
metabolism study, which was later waived. In September 1991, EPA
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issued a Data Call-In (DCI) requiring product ciemistry data and a repeat
of the hydrolysis study (which was later rescinded).
EPA has now completed its review of the OBPA data base, including
the data submitted in response to the 1991 DCI.
Human Health OBPA shows a high degree of acute toxicity when administered
Assessment oraUy a* to the skin and eyes. It has been placed in Toxicity Category I
indicating the highest degree of acute toxicity for these effects.
In subacute feeding studies using rats, animals fed the highest dose
levels had retarded growth, liver effects and an accumulation of arsenic in
the liver and kidneys. In a subacute inhalation study, rats and guinea pigs
sacrificed 48 hours after their last exposure to OBPA had mild to moderate
heart effects and the rats had liver effects. Animals kept four months
longer with no further exposure showed no effects of OBPA.
OBPA dees not appear to cause developmental or reproductive
toxicity, and shows no mutagenic activity. Metabolism studies show that
arsenic accumulates in the liver and kidneys as a result of exposure to
OBPA, however this arsenic is cleared from the body after two weeks.
Dietary Exposure
OBPA is not registered for use on food, feed or processed
commodities. Therefore, dietary exposure or risk is not expected.
Occupational and Residential Exposure
Although occupational and residential exposure to OBPA occurs,
such exposure is indirect and/or extremely low level. Direct occupational
exposure during production of pesticide or plastic products containing
OBPA is mitigated by the use of closed systems and appropriate protective
gloves and eyewear. Indirect residential and other human exposure to
OBPA in treated plastics is low because only a small percent of OBPA is
added to these products, and only small amounts of OBPA are released,
very slowly.
Human Risk Assessment
OBPA does not pose human dietary risks since no food-related uses
are registered and dietary exposure is not anticipated.
The potential for occupational exposure to OBPA is minimal
provided that OBPA is used in a closed system and that appropriate
Personal Protective Equipment (PPE) is worn. Residential exposure to
OBPA is indirect and low level. No additional uses are proposed that
would significantly increase human exposure to OBPA. Therefore, the
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potential human risks from exposure to OBPA pesticides are likely to be
minimal.
Environmental
Assessment
Environmental Fate
No further environmental fete data are needed because of the very
limited environmental exposure expected from current uses of OBPA. The
Registration Standard required an activated sludge study, which was later
waived, and a hydrolysis study. The hydrolysis study was found deficient,
but the Agency later determined that an additional hydrolysis study was not
needed based on the fact that OBPA-treated materials will not result in
significant levels of residues being released into the environment. An
extractability study on pool liners and vinyl baby pants showed that
leaching would not result in residues that exceed the 50 ppb maximum
limit established for arsenic in drinking water.
Ecological Effects
Studies usually required to determine effects on birds, fish and other
nontarget organisms are waived because of OBPA's indoor, industrial use
pattern. Avian and aquatic toxicity information is needed only to assess the need
for precautionary label statements.
Since OBPA is highly corrosive, it would be very highly toxic to birds.
Existing acute oral rat studies confirm that OBPA is highly toxic to terrestrial
organisms.
Aquatic studies show that OBPA is very highly toxic to both freshwater
and marine fish, and to freshwater aquatic and marine invertebrates, on an acute
basis.
Ecological Effects Risk Assessment
OBPA is an indoor, non-food, industrial use pesticide which is
incorporated into plastics, textiles, adhesives, etc.. The Agency does not
conduct risk assessments for nontarget organisms for indoor uses without
effluent. Should residues of OBPA in effluent ever exceed 1.75 ppb, aquatic
organisms would be acutely at risk.
Additional Data BPA is requiring product-specific data, including product chemistry
Required &"<* acute toxicity studies, as well as revised Confidential Statements of
Formula and revised labeling for reregistration of pesticide products
containing OBPA.
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Product Labeling The labels of all registered pesticide products containing OBPA must
Changes Required comply with EPA's current pesticide labeling requirements. End-use and
manufacturing use products also must bear the following label statement in
the Environmental Hazards section:
"This pesticide is toxic to fish, aquatic invertebrates, birds, and
mammals. Do not discharge effluent containing this product into
lakes, streams, ponds, estuaries, oceans, or other waters unless in
accordance with the requirements of a National Pollutant Discharge
Elimination System (NPDES) permit and the permitting authority has
been notified in writing prior to discharge. Do not discharge effluent
containing this product into sewer systems without previously
notifying the local sewage treatment plant authority. For guidance
contact your State Water Board or Regionjd Office of EPA."
In addition, labels must consistently reflect any potential eye and skin
hazard (Danger, Warning or Caution Signal Wcwxls) and recommend
appropriate protective equipment (protective eyeware [goggles or face
shield], waterproof gloves, long sleeved shirts and long-legged pants, shoes
and socks).
Regulatory
Conclusion
The use of currently registered pesticide products containing OBPA
in accordance with approved labeling will not pose unreasonable risks or
adverse effects to humans or the environment. Therefore, all uses of these
products are eligible for reregistration.
These OBPA products will be reregistered once the required product-
specific data, revised Confidential Statements of Formula and revised
labeling are received and accepted by EPA. Products which contain other
active ingredients in addition to OBPA will be eligible for reregistration
only when all of their other active ingredients also are determined to be
eligible.
For More
Information
EPA is requesting public comments on the Reregistration Eligibility
Document (RED) for OBPA 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 or to submit written comment*., please contact the
Pesticide Docket, Public Response and Program Resources Branch, Field
Operations Division (H-7506C), Office of Pesticide Programs (OPP), US
EPA, Washington, DC 20460, telephone 703-305-5805.
Following the comment period, the OBPA RED 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 OBPA or about EPA's pesticide
reregistration program, please contact the Special Review and
Reregistration Division (H-7508W), OPP, US EPA, Washington, DC
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20460, telephone 703-308-8000. For information about reregistration of
individual products containing OBPA, please contact Product Manager -
Cynthia Giles-Parker, Registration Division (H-7505C), OPP, US EPA,
Vtoshington, DC 20460, telephone 703-305-5540.
For information about the health effects of pesticides, or for
assistance in recognizing and managing pesticide poisoning symptoms,
please contact the National Pesticides Telecommunications Network
(NPTN). Call toll-free 1-800-858-7378, between 8:00 am and 6:00 pm
Central Time, Monday through Friday.
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OBPA
Summary of Requirements
Within 90 Davs of Receipt of this RED
1. Sign and submit data call-in response forms attached to the product specific DCI
(Appendix G, Attachment 8 and C).
Within 8 Months From the Date of this RED
1. Submit a completed Application for Reregistration (EPA Form 8570-1).
2. Submit five copies of the label and labeling revised as specified by the RED and in
accordance with current requirements.
3. Submit two completed copies of the Confidential Statement of Formula (EPA Form 8570-
4).
4. Submit a completed Certification With Respect to Data Compensation (EPA Form 8570-
31), if applicable. EPA Form 8570-31 is required to establish ownership of product
specific data only and allows only two options: development of data (owner submission
method); and citing of specific data (selective method requiring a data matrix). The cite
all method of support is not an acceptable option for responding to the product specific
data requirements of the RED.
5. Submit the required data or references to data as specified by the RED/DCI for product
specific data (Appendix G). Please note that products listed in Table I (Attachment D)
did not fall into any batch. Therefore the acute toxicology data required in the product
specific DCI (Appendix G) must be submitted for these products, (i.e., the grouping of
similar products for purposes of submitting acute toxicology data does not apply to those
products listed in Table I of Appendix G, Attachment D). All data submitted to fulfill
requirements listed in Appendix G should be sent to:
Document Processing Desk (RED/RD/PM22)
Office of Pesticide Programs (H7504C)
Environmental Protection Agency
401 M Street, S.W.
Washington, D.C. 20460-0001
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REREGISTRATION ELIGIBILITY DOCUMENT
10,10'-OXYBISPHENOXARSINE (OBPA)
LIST A
CASE 0044
ENVKONMENTAL-mOTECTION-ACENCY
OFHCE-OF-nsnCIDE-FROGRAMS
SPECIAL-KEVIEW-AND'IlEREraSTOA'nON-DIVISION
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OBPA REREGISTRATION ELIGIBILITY TEAM
Office of Pesticide Programs:
Biological*and Economic- Analysis-Division
Rafael Prieto
Alan Halvorson
Environmental-Fate-and'Effects-Division
David Farrar
Richard Lee
Patricia Ott
Health-Effects-Division
Linda Kutney
Patricia McLaughlin
Jeff Evans
Registration Division
Theresa Stowe
Joanne Hayes
Bipin Gandhi
Special-Review and-Reregistration Division
Venus Eagle
Carol Stangle
Gene Frane
Biological Analysis- Branch
Economic Analysis Branch
Science Analysis and Coordination Staff
Ecological Effects Branch
Environmental Fate and Ground water Branch
Chemical Coordination Branch
Toxicology Branch n
Occupational and Residential Exposure Branch
Fungicide-Herbicide Branch
Registration Support Branch
Registration Support Branch
Reregistration-Branch
PolicyPlanning-and-Operations-Branch
Policy and Special Projects Staff
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GLOSSARY OF TERMS AND ABBREVIATIONS
a.i. Active Ingredient
CAS Chemical Abstracts Service
CSF Confidential Statement of Formula
"EEC Estimated Environmental Concentration. The estimated pesticide concentration
in an environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FZFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
HDT Highest Dose Tested
LCW Median Lethal Concentration. A statistically derived concentration of a substance
that can be expected to cause death in 50% of test animals. It is usually
expressed as the weight of substance per weight or volume of water or feed, e.g.,
mg/1 or ppm.
LDjo Median Lethal Dose. A statistically derived single dose that can be expected to
cause death in 50% of the test animals when administered by the route indicated
(oral, dermal). It is expressed as a weight of substance per unit weight of animal,
e.g., mg/kg.
LD,,, Lethal Dose-low. Lowest Dose at which lethality occurs
LKT, Lowest Effect Level
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of recording and tracking
studies submitted.
N/A Not Applicable
ii
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NPDES
NOEL
OPP
PADI
ppm
RfD
R5
TD
TC
TMRC
TEP
GLOSSARY OF TERMS AND ABBREVIATIONS (cent.)
National Pollutant Discharge Elimination System
No Observed Effect Level
Office of Pesticide Programs
Provisional Acceptable Daily Intake
Parts Per Million
Reference Dose
Registration Standard
Toxic Dose. The dose at which a substance produces a toxic effect.
Toxic Concentration. The dose at which a substance produces a toxic effect.
Theoretical Maximum Residue Contribution.
Typical End-Use Product
iii
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TABLE OF CONTENTS
OBPA REREGISTRATTON ELIGIBILITY TEAM i
GLOSSARY OF TERMS AND ABBREVIATIONS ii
EXECUTIVE SUMMARY vi
I. INTRODUCTION 1
IL CASE OVERVIEW 2
A. Chemical Overview 2
B. U§e Profile 2
C. Data Requirements 4
D. Regulatory History 4
m. SCIENCE ASSESSMENT 4
A. Physical Chemistry Assessment 4
B* Human Health Assessment 5
1. Toxicology Assessment 5
a. Acute Tozichy 5
b. Subchronic Toxidty 6
c. Developmental Tozichy and Reproductive Toxicity .... 7
d. Mutagenicfty 7
e. Metabolism 7
2. Exposure Assessment 7
a. Dietary Exposure 7
b. Occupational and Residential 7
3. Risk Assessment , 8
a. Dietary 8
b. Occupational and Rfiflgitfal 9
C. Environmental Assessment 9
1. Environmental Fate 9
2. Ecological Effects 9
a. Ecological Effects Data 10
(1) Terrestrial Data - Effects on Birds 10
(2) Aquatic Data 11
(3) Effects to Non-target Aquatic Invertebrates .... 13
(4) Non-Target Estuarine and Marine Organisms ... 13
(5) Non-Target Insects 13
(6) Non-Target Plants 14
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 14
A. Determination of Eligibility 14
IV
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V.
1. Eligibility Decision 15
2. Eligible and Ineligible Uses IS
B. Regulatory Position 15
1. Tolerance Reassessment 15
2. Labeling Rationale 15
a. Manufacturing Use 15
b. End Use 15
ACTIONS REQUIRED BY REGISTRANTS 16
A. Manufacturing-Use Products 16
1. Additional Generic Data Requirements 16
2. Labeling Requirements for Manufacturing-Use Products 16
B. End-Use Products 16
1. Additional Product-Specific Data Requirements 16
2. Labeling Requirements for End-Use Products 17
VI. APPENDICES
Appendix A - Use Patterns Subject to Reregistration
Appendix B - Table of the Generic Data Requirements and Studies Used to Make the
Reregistration Decision
Appendix C - Citations Considered to be Part of the Data Base Supporting the
Reregistration of OBP A
Appendix D - List of Available Related Documents
Appendix B - Pesticide Reregistration Handbook
Appendix F - Generic Data Call-In
Appendix G - Product Specific Data Call-In
Attachment A -
Attachment B -
Attachment C -
Attachment D -
Attachment B -
Attachment F -
Attachment G -
Chemical Status Sheet
Product Specific DCI Response Fonns (Form A) plus
Instructions
Requirements Status and Registrants' Response Forms
(Form B) phis Instructions
EPA Grouping of End Use Products for meeting Acute
Toxicology Data Requirements.
EPA Acceptance Criteria
List of all Registrant(s) sent this DCI
Cost Share/Data Compensation Forms
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EXECUTIVE SUMMARY
This Reregistration Eligibility Document (RED) will address the eligibility for
reregistration of products containing 10, 10'- Oxybisphenoxarsine (OBPA).
OBPA is a bacteriostat, disinfectant (bacteriocide/gennicide) and fungicide pesticide. Its
use category is: indoor non-food. This arsenic-containing helerocyclic compound is
incorporated into flexible vinyl sheeting and extrusions, silicons caulking compounds,
thermoplastic adhesives, polyurethane, and latex emulsions (not including paints, ink bases and
textiles) to prevent the growth of microorganisms. Although flexible! vinyls and silicones in
themselves are resistant to microbiological deterioration, the use of OBPA formulations in
products made from these materials is necessary due to microbial susceptibility of plasticizers,
lubricants, and fillers which are added to obtain desirable physical and! chemical properties.
OBPA is formulated as an emulsifiable concentrate, pelleted/tableted, soluble
concentrate/liquid and ready-to-use liquid. The concentration varies irom 1 to 5%, based on
total weight of formulation.
OBPA was initially registered as a pesticide in 1965. A Registration Standard was issued
October 30, 1981 (NTIS PB82-172271). This Registration Standard summarized the available
data supporting the reregistration of products containing OBPA which were used as indoor (non-
rood) antimicrobials. The Registration Standard also required additional product chemistry, a
hydrolysis study and an activated sludge metabolism study, which was later waived. A Data
Call-in (DO), dated September 30,1991, was issued requiring product chemistry and the repeat
of the hydrolysis study. The Agency has now completed its review of the OBPA data base
including the data submitted in response to the 1991 DCL
The Agency has determined that the uses of OBPA as currently registered will not cause
unreasonable risk to humans or the environment and these uses are eligible for reregistration.
The Agency is not requiring any additional generic studies to be submitted at this time.
Before reregistering the products containing OBPA, the Agency is requiring that product
specific data, revised Confidential Statements of Formula (CSF) and revised labeling be
submitted within eight months of the issuance of this document. These data include product
chemistry for each registration and acute toxicity testing. After reviewing these data and any
revised labels and finding them acceptable, the Agency will reregister a product based on
whether or not it meets the requirements in Section 3(c)(5) of FIFRA. Those products which
contain other active ingredients in addition to OBPA will be eligible for leregistration only when
all of the other active ingredients are determined to be eligible for rerejnstration.
VI
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodeoticide Act (FIFRA) was amended
to accelerate the registration of products with active ingredients registered prior to November
1, 1984. The amended Act provides a schedule for the reregistration process to be completed
in nine years. There are five phases to the reregistration process. The first four phases of the
process focus on identification of data requirements to support the reregistration of an active
ingredient and the generation and submission of data to fulfill the requirements. The fifth phase
is a review by the U.S. Environmental Protection Agency (referred to as "the Agency") of all
data submitted to support reregistration.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine whether
pesticides containing such active ingredient are eligible for registration" 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 OBPA. The document consists of six sections. Section I is the introduction.
Section n describes OBPA, its uses, data requirements and regulatory history. Section ffl
discusses the human health and environmental assessment based on the data available to the
Agency. Section IV presents the reregistration decision for OBPA . Section V discusses the
reregistration requirements for OBPA. Finally, Section VI is the Appendices which support this
Reregistration Eligibility Document. Additional details concerning the Agency's review of
applicable data are available on request.1
lEPA's reviews of data on the set of registered uses considered for EPA's analysis may be
obtained from the OPP Public Docket, Field Operations Division (H7506C), Office of Pesticide
Programs, EPA, Washington, DC 20460.
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H. CASE OVERVIEW
A. Chemical Ovierview
The following active ingiedient(s) axe covered by this Reregistration Eligibility
Document:
Common Name: OBPA
Chemical Name: 10,10'-Oxybisphenoxarsine
Chemical Family; Thenarsazine oxide
CAS Registry Number: 58-36-6
OFF Chemical Code: 012601
Empirical Formula:
Molecular Weight:
502
Trade and Other Names: Policida P-4
Basic Manufacturer: Morton Thiokol, Inc.
B. Use Profde
Following is information on the current registered uses with an overview of use
sites and application methods. A detailed table of the uses of OBPA is found in
Appendix A.
For OBPA:
Type of Pesticide:
Bacteriostat, Disinfectant (bacteriocide/gennicide)
and Fungicide.
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Use Sites:
INDOOR NON-FOOD:
Industrial Adhesives
Resin/Latex/Polymer Emulsions
Plastic Products
Speciality Industrial Products
Textiles/Textile Fibers/Cordage
Target Pests:
Deterioration/spoilage bacteria, Mold.
Formulation Types
Registered
Type:
Form:
End use, Manufacturing use
Emulsifiable concentrate, Liquid soluble concentrate, Solid
soluble concentrate, Solid formulation not identified
(manufacturing use)
Methods and Rates of Application
Types of Treatment: Industrial preservative
Equipment: Not applicable
Timing: During manufacture
Rate of Application:
Industrial adhesives:
From 150 up to 500 ppm of active ingredient by weight
Resin/latex/polymer emulsions:
From 150 up to 400 ppm of active ingredient by weight
Plastic products:
From 300 up to 500 ppm of active ingredient by weight
Specialty industrial products:
From 150 up to 400 ppm of active ingredient by weight
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Textiles/textile fibers/cordage:
From 400 up to 1000 ppm of active ingredient by weight
Use Practices Limitations: Product should noi: be used on items which
come into contact with food stuffs nor items
of clothing or infiint wear. Do not apply
directly to water.
C. Data Requirements
Data required in the October 1981 Registration Standard for OBPA include studies
on product chemistry, a hydrolysis study and an activated sludge metabolism study,
which was later waived. These data were required to support the uses listed in the
Registration Standard. Appendix B includes all data requirements identified by the
Agency for currently registered uses needed to support reregisxation.
D. Regulatory History
OBPA was registered in the United States in 1965 for use as a disinfectant
(bacteriocide/gennicide), bacteriostat, and fungicide. A Registration Standard for OBPA
was issued in October 1981 (NTIS PB82-172271) which evaluated studies submitted as
a result of (1) an open literature search as of August 14,1981 (2) the Agency's April 20,
1979 decision document to remove OBPA from the RebuttaMe Presumption Against
Registration (RPAR) list and (3) the data submitted by the registrants up through the time
of publication of the 1981 Registration Standard. A Data Call-In (DO) was issued in
September 1991 for OBPA requiring additional product chemistry for Morton Thiokol,
Inc. and a repeat hydrolysis; study to replace the existing iitudy which was found
deficient. This Registration Eligibility Document reflects a reassessment of all data
which were submitted in response to the Registration Standard and subsequent DCI.
SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
OBPA is a white odorless powder which has a density of 0.489 g/ml. It is
insoluble in water. The vapor pressure is extremely low of less than 2.0 x 10~7 at 25.T
C. This chemical is stable to sunlight and a temperature of 54* C. It is also stable to
aluminum, copper, galvanized! steel and stainless steel. OBPA is not an oxidizing and
reducing agent and is non-flammable, non-explosive and non-corrosive.
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B. Human Health Assessment
1. Toxicology Assessment
The toxicological database on OBPA is adequate and will support
registration.
a. Acute Toxicity
Several acute toxicity studies of each type have been done with
OBPA, some of which do not provide complete information. The more
completely reported studies are summarized here. In general, the acute
oral toxicity studies with technical OBPA found LDSO's from about 15 to
40 mg/kg. A more complete report of a test in rats with technical OBPA
had an LD50 of 36.9 mg/kg in males and of 31.6 in females (Anspach,
1977, GS044002). The toxic effects included congested adrenals, kidneys,
and lungs, irritated digestive systems, and depleted fat stores. These
results indicate toxicity category I.
The results found in acute dermal toxicity studies with technical
OBPA varied widely. A study with rabbits using technical OBPA found
an LD50 of 414 mg/kg (Anspach, 1977, GS044002). One that used
technical OBPA on rats reported an LD50 of 121 mg/kg (Litton Bionetics,
1978, GS044039). OBPA is in Toxicity category I for dermal toxicity.
An acute inhalation toxicity study with guinea pigs estimated the
LC50 at 1279 mg/L, results which place this compound in toxicity
category IV for inhalation (Ballantyne, 1978, 05015857).
Two primary eye irritation studies in rabbits with technical OBPA
found cornea! opacity, conjunctivitis, and iritis (Anspach, 1977,
00013643; GS044002). In one study the effects lasted through 72 hours.
The Agency considers this material to be in toxicity category I for eye
irritation.
Results in different primary skin irritation studies were quite
varied. One study with technical OBPA applied to intact and abraded skin
of rabbits found slight to severe edema and peripheral or spotted
erythema, results which fall in toxicity category n (Anspach, 1977,
0013643). Another study applied technical material to intact and abraded
rabbit skin for 24 hours; the results indicated toxicity category HI
(Anspach, 1977, GS044002). The Agency considers that OBPA is in
category n for dermal irritation.
-------
TABLE OF ACUTE TOXIOTY DATA
TEST
Acute Oral LD*, (rat)
Acute Dermal LDM
(rat, rabbit)
Acute Inhalation LC«n
(guinea pig)
Eye Irritation
(rabbit)
Skin Irritation
(rabbit)
RESULT
15-40 mg/kg
121-414 mg/kg
1279 mg/L
Cornea! Opacity
Varies
(edema, erythema)
TOXIOTY CATEGORY
I
I
IV
I
n
b. Subchronic Toxtdty
In a 35-day feeding study, 10 rats/sex/dose were given 0, 1, 10,
30, 100, or 300 ppm of OBPA in the diet (the percent active ingredient
was not stated; Franz and Shrader 1959, 00024936; Oxen 1959,
00024940). Generally, animals at the two higher doses had retarded
growth, higher liver weights, increased testes weights, proliferation of the
portal bile duct, and accumulation of arsenic in liver and kidneys. The
NOEL was 10 ppm (approximately 0.5 mg/kg/dj.y).
A rat feeding study lasting 92 days gave doses of 0,0.03,0.1,0.3,
1.0 or 3.0 mg/kg/day to 10 rats/sex/dose (unspecified percent active
ingredient; McCollister et al. 1969, GS044042). Ilie high dose group had
retarded growth as well as lack of fat in the mesentery; there were
microscopic liver lesions and inflammatory cellular infiltrates in the
periportal area with bile duct hyperplasia. Arsenic accumulated in the
liver and kidney at all doses fln<* in the fat and hair in some of the higher
doses. The NOEL was 1.0 mg/kg/day.
In an inhalation study, both rats and guinea pigs were exposed to
1-2 mg/M3 of technical OBPA (percent not stated) during five days per
week for 30 days (IPC 1957, 00013591; Ballaniyne 1978, 05015857).
Half of the animals were sacrificed 48 hours after the last exposure and
the others were kept without further exposure for four months. The rats
and guinea pigs killed at 48 hours had mild to moderate pulmonary
congestion and hemorrhaging; only the rats had hejMtic involvement. The
animals killed four months later showed no effects of OBPA.
-------
c. Developmental Toxicity and Reproductive Toridty
An investigation of the effect of OBPA on fetal development and
toxicity used dermal applications at 0.3, 3.0 or 30.0 mg/kg on pregnant
rats (Beliles and Makris 1978, GS0440007). However, the animals also
ingested the material put on their skin and the actual doses are uncertain.
All high-dose rats and one mid-dose rat died during the test. There was
no evidence of compound-related teratogenicity or inhibition of fetal
development from the surviving animals. There was some evidence of
fetal toxicity in the mid-dose group and the NOEL was estimated at 0.3
mg/kg.
d. Mutagenicity
A mouse lymphoma test was considered negative for mutagenicity
with and without activation (Brusick and Weir 1976, 00013644). A
mutagenicity study in S* cerevisiae and JL typhimurium with and without
activation did not show mutagenicity (Brusick and Weir 1976,00013647).
An investigation of the metabolites of OBPA used the urine of rats treated
with OBPA in the method of Durston and Ames. There was no indication
of mutagenic activity with urine from treated or untreated rats (Beliles and
Makris 1978, GS044007).
e. Metabolism
Metabolism studies in which OBPA was applied to the skin
generally found arsenic accumulation in the liver and kidney with removal
from the body through both feces and urine (Olson et al.1959, 00026092;
Dow 1964,00024935; Ballantyne 1978,05015857). There are indications
that the arsenic is cleared from the body after two weeks.
2. Exposure Assessment
a. Dietary Exposure
OBPA is not used on food, feed or processed commodities; dietary
exposure to OBPA is not expected.
b. Occupational and Residential
OBPA is an antimicrobial and antifungal pesticide used to treat
polyvinylchloride (PVC), polyuiethane, and ethylene-vinylacetate
copolymer plastics. These plastics are fabricated into shower curtains,
-------
floor coverings, wall coverings, ditch liners, coated fabrics (including
mattresses), vinyl molding, marine upholstery, automotive vinyl trim,
tarpaulins, awnings, gaskets (automotive, refrigerator, dishwasher),
weather stripping, caulking, and swimming pool liners. Plastic products
intended for indoor use contain up to 0.06% OBPA and plastic products
intended for outdoor use contain up to 0.05% OBPA.
OBPA formulations range in concentrations from 1 to 5%. The
OBPA formulations are either liquids or pelletai/tableted forms utilizing
a resin carrier.
Occupational and iygid«ntiai exposure data were not required in the
1981 Registration Standard for OBPA based on the following reasons:
1) direct occupational exposure to OBPA is mitigated by the use
of closed systems, when producing OBPA technical and OBPA
formulations, or when producing plastic products containing
OBPA;
2) indirect human exposure to OBPA ;in treated plastics is low
due to the low percent of OBPA added to plastic coupled with the
slow release of small amounts of OBPA from the plastic matrix;
and
3) no additional uses are proposed that may result in significant
increases in human exposure.
(Inhalation exposure from OBPA-treated products is negligible
since it has a low vapor pressure.)
Based on the low potential for exposure ix> OBPA, exposure data
are not required to support the reregistration of the current uses of OBPA,
provided that (1) manufacturing is under closed systems, and (2)
appropriate Personal Protective Equipment (PPE) is used.
3* Risk Assessment
a. Dietary
There are no registered food or feed uses of OBPA, and therefore,
dietary exposure or risk from OBPA is not expected.
8
-------
c.
b. Occupational and Residential
The potential for occupational exposure to OBPA is minimal
provided that OBPA is used in a closed system and that appropriate
protective eyewear and gloves are used. Therefore, the potential risk for
acute or chronic toxicity from exposure to OBPA is also likely to be
In 1991, the Agency received a research proposal concerning the
potential linkage between OBPA-treated mattresses to Sudden Infant Death
Syndrome (SIDS). The proposal to investigate this environmental factor
as a possible cause of SIDS was submitted by Dr. Julius Goldberg of the
Loyola University Medical Center in Chicago, Illinois. As support for the
proposal was the hypothesis that toxic gases may be produced by
microfungi which attack PVC plastic material, Some of these fungi can
break down the arsenates in the PVC, and produce trimethyl arsine
(AUsop and Hawksworth, 1992). However, in that study, the
investigators could not draw any general conclusions regarding the
significance of biofilms or other fungi that were isolated; this was due
primarily to the limited number of mattress covers studied and the use of
unmatched controls.
At the present tune, there is no evidence to suggest that OBPA is
linked to SIDS. A causal relationship between SIDS and environmental
factors (or genetic factors) has not been established.
Environmental Assessment
1. Environmental Fate
The Agency finds that no further environmental fate data are needed
because of the very limited exposure expected with current uses of this chemical.
The Registration Standard required a hydrolysis study and an activated sludge
study, which was later waived. The hydrolysis study was found deficient, but the
Agency later determined that an additional hydrolysis study was not needed based
on the fact that OBPA-treated material will not result in significant levels of
residues being released into the environment. An extractability study on pool
liners and vinyl baby pants showed that leaching would not result in exceedance
of the 50 ppb maximum daily dietary intake for arsenic in drinking water.
2. Ecological Effects
No further ecological effects toxicity data are required to support current
uses of this chemical.
-------
a. Ecological Effects Data
Topical Summaries
(1) Terrestrial Data - Effects on Birds
'Two studies were submitted and both were found to be
scientifically sound.
Author
Fink
Fink
Dat»
1976
1976
MRZO Mo.
00012:648
00012:649
Avian Acute Toxicitv Test Technical Active Ingredient
The following tests are normally required to measure toxicity of
technical grade active ingredient (TGAI):
One avian single-dose oral study on either a waterfowl species
(preferably mallard duck) or an upkind species (preferably
bobwhite quail).
One subacute dietary study on either a waterfowl species
(preferably mallard duck) or an uphmd species (preferably
bobwhite quail).
No studies were conducted on the technical material, therefore
normally a data gap would exist. However, the usual studies will
be waived because: 1) the material iis highly corrosive and
therefore will be very highly toxic to birds; 2) existing acute oral
rat data (45 mg/kg males and IS mg/l:g females) confirm the
pesticide's high toxicity to terrestrial orgjjiisms; 3) the indoor use
pattern does not require a risk assessment for birds, and avian
toxicity information is needed only to assess the need for
precautionary label statements.
cute Toxicit Test Tical id-Use Product
Studies are not required to support indoor non-food (industrial) use
patterns. The single available acute oral toxicity study for a
typical end-use product (TEP) is:
10
-------
S|MCiM
.
Avian oral
Mallard
duck
%Ta«t
Malarial
6%
TEP
ID*
mg/kg
product
> 10,000
Author
FJfMC
Dm*
1976
MRIDNo.
00013648
Fitfflb
RwiufrMMnti
No
raquiramant
Hie data indicate that OBPA (5%) is practically non-toxic to
mallard duck (waterfowl species) on an acute oral basis.
The single available subacute dietary toxicity study is listed
below:
*.,
Avian ditt.
Botwhitt
quail
X Tart
Material
5 X
TEP
U»
KM product
>10,000
Author
Fink
Date
1976
MID Mo.
00013640
Fulfill*
Rwpri navntv
Ho
raqufraawtt
These data indicate that OBPA (5%) is practically non-toxic to
bobwbite quail (upland bird species) on a subacute dietary basis.
(2) Aquatic Data
Nine studies (in five reports) were submitted under this topic. All
were found acceptable for use in a hazard assessment.
Author
Buccafusco
Heitmuller
Bentley
Lee & Regel
WARF
Date
1977
1980
1976
1974
1973
MRIDNo.
GS044009
00030658
00013641
GS044067
00013611
The minimum ffyfa required for establishing the acute toxicity of
OBPA to freshwater fish is one fish acute toxicity study with the
technical material. The preferred test species is either rainbow
trout or bluegill sunfish.
11
-------
Fish Acute Toxicitv Test Technical Active Ingredient
The acceptable acute toxicity data are listed below:
*
Rainbow
wit
aunfiah
filkAAMBtlABuf
minnow
%A.L
96.6%
96.6%
96.6%
LC.
ppb,.J.
3.5
t.O
.0
A
BlMMMlflMOO
*""
lialuuuiai
.-.
1977
1S77
1990
ID*
0804400*
0*044009
00030669
jj^,
-------
requirements for Ash acute toxicity tests for OBPA with the typical
end-use product. These studies showed that the 5% OBPA
formulated product is practically non-toxic to freshwater fish in
acute exposure. However, other studies using the products with
lower contents of OBPA (2 & 3% a.i.) were found to be highly
toxic to freshwater fish on an acute basis.
(3) Effects to Non-target Aquatic Invertebrates
Two studies were found acceptable for use in a hazard assessment:
Author
Browne
Heitmuller
Date
1980
1979
HRZD Mo.
00030657
00030656
The requirement to establish the acute toxicity of OBPA to aquatic
invertebrates is a 48-h. DadUM acute toxicity study using the
technical material. The acceptable toxicity data are listed below:
Specie*
Uaphaia
aagoa.
Grass
shrimp
\ Test
Material
99.0 %
95.6 %
LCM
ppb a.i.
4.8
50.0
Author
Browne
Heitmull
er
Date
1980
1979
MAID NO.
00030657
00030656
Fulfill*
Raquirema
nts
Yes
Yes
The Daphnia test fulfills the guideline requirement for acute
freshwater invertebrate toxicity testing. The data indicate that
OBPA is very highly toxic to freshwater aquatic invertebrates. A
marine acute invertebrate toxicity study is not required for this
end-use. However, the grass shrimp study would fulfill the
guideline requirement for a marine invertebrate study. That study
shows that OBPA is very highly toxic to a marine invertebrate on
an acute basis.
(4) Non-Target Estuarine and Marine Organisms
No toxicity data are required for the end-uses registered.
(5) Non-Target Insects
13
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No toxicity data axe required for the end-uses registered.
«5) Non-Target Plants
No toxicity data are required for the end-uses registered.
b. Ecological Effects Risk Assessment
OBPA is an indoor non-food use pesticide which is incorporated
into plastics, adhesives, textiles etc. The Agency does not conduct risk
assessments for nontarget organisms for indoor uses without effluent.
Risk assessments for uses with effluent are based on residues in natural
waters receiving the effluent. Should such residues of OBPA exceed
1.75 ppb, aquatic organisms are acutely at risk, This level is based on
acute LC50 for the technical active ingredient is low as 3.5 ppb for an
aquatic organism (rainbow bout).
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission
of relevant data concerning an active ingredient, whether products containing the active
ingredient are eligible for reregistxation. 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 OBPA as an active ingredient. The Agency
has completed its review of these generic data, and has determined that the data are
sufficient to support reregistration of all products containing OBPA. Appendix B
identifies the generic data requirements that the Agency leviewed as part of its
determination of reregistration eligibility of OBPA, and lists die submitted studies that
the Agency found acceptable.
The data identified in Appendix B were sufficient to allow the Agency to assess
the registered uses of OBPA and to determine that OBPA can be used without resulting
in unreasonable adverse effects to man or the environment. Ths Agency therefore finds
that all products containing OBPA as the active ingredient axe eligible for reregistration.
The reregistration of particular products is addressed in Section V of this document.
The Agency made its reregistration eligibility determination based upon the target
data base required for reregistration, the current guidelines for conducting acceptable
studies to generate such data iml the data identified in Appendix B. Although the
Agency has found that all uses of OBPA are eligible for Registration, it should be
understood that the Agency may take appropriate regulatory atrion, and/or require the
submission of additional data to support the registration of products containing OBPA,
14
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if new information comes to the Agency's attention or if the data requirements for
reregistration (or the guidelines for generating such data) change.
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredient OBPA,
the Agency has sufficient information on the health effects of OBPA and on its
potential for causing adverse effects in fish and wildlife and the environment.
Therefore, the Agency concludes that products containing OBPA for all uses are
eligible for reregistration.
The Agency has determined that OBPA products, labeled and used as
specified in this Reregistration Eligibility Document, will not pose unreasonable
risks or adverse effects to humans or the environment
2. Eligible and Ineligible Uses
The Agency has determined that all uses of OBPA are eligible for
reregistration.
B. Regulatory Position
The following is a summary of the regulatory positions and rationales for OBPA.
Where labeling revisions are imposed, specific language is set forth in Section V of this
document.
1. Tolerance Reassessment
There are no registered uses for OBPA in or on food or feed.
2. Labeling Rationale
The "Environmental Hazards" section should include the following:
a. Manufacturing Use
"This pesticide is toxic to fish, aquatic invertebrates, birds, and mammals.
Do not discharge effluent containing this product into lakes, streams,
ponds, estuaries, oceans or other waters unless in accordance with the
requirements of a National Pollutant Discharge Elimination System
(NPDES) permit and the permitting authority has been notified in writing
prior to discharge. Do not discharge effluent containing this product into
sewer systems without previously notifying the local sewage treatment
plant authority. For guidance contact you State Water Board or Regional
Office of the EPA."
15
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b. End Use
Indoor (Industrial use) - Same language as for the manufacturing use.
V. ACTIONS REQUIRED BY REGISTRANTS
This section specifies the data requirements and responses necessary for the reregistration
of both manufacturing-use and end-use products.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistraticn of OBPA for the above
eligible uses has been reviewed and determined to bo substantially complete.
However, some of the product chemistry guidelines hive not been completely
fulfilled.
All of the product chemistry data for OBPA were originally required in
the Registration Standard and are therefore not included in a generic Data Call-In
for the RED.
There are no new generic data being called-in for OBPA.
2. Labeling Requirements for Manufacturing-U!* Products
The "Environmental Hazards" section is to include the following:
"This pesticide is toxic to fish, aquatic invertebrates, birds, and mammals.
Do not discharge effluent containing this product into lakes, streams, ponds,
estuaries, oceans or other waters unless in accordance with the requirements of
a National Pollutant Discharge Elimination System (I'fPDES) permit and the
permitting authority has been notified in writing prior to discharge. Do not
discharge effluent containing this product into sewer systems without previously
notifying the local sewage treatment plant authority. For guidance contact your
State Water Board or Regional Office of the EPA."
In addition, labels must consistently reflect any potential eye and skin
hazard (Danger, Warning or Caution Signal Words) and recommend appropriate
personal protective equipment (protective eyeware {goggles or face shield}, long
sleeved shirts and long-legged pants, waterproof gloves, shoes and socks).
B. End-Use Products
1. Additional Product-Specific Data Requirements
16
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Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide after a determination of eligibility
has been made. The product specific data requirements are listed in Appendix
G, the Product Specific Data Call-in Notice.
Registrants must review previous data submissions to ensure that they meet
current EPA acceptance criteria (Appendix F; Attachment E) and if not, commit
to conduct new studies. If a registrant believes that previously submitted data
meet current testing standards, then study MRID numbers should be cited
according to the instructions in the Requirement Status and Registrants Response
Form provided for each product.
2. Labeling Requirements for End-Use Products
Same language as for the manufacturing use.
End-use product labeling and personal protective equipment requirements
will be determined upon submission or citation and review of acute toxicity
studies conducted on the end-use product.
17
-------
APPENDIX A
Table of Use Patterns
Subject to Reregis
18
-------
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APPENDIX B
Table of the Generic Data Requirements
and Studies Used to Make the
Reregistration Decision
20
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GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for the
pesticide Oxybisphenoxarsine (OBPA) covered by this Reregistration Eligibility Document. It
contains generic data requirements that apply to OBPA 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
B Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files, this
column lists the identifying number of each study. This normally is the Master Record
Identification (MRID) number, but may be a "GS" number if no MRID number has been
assigned. Refer to the Bibliography appendix for a complete citation of the study.
21
-------
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25
-------
APPENDIX C
BIBLIOGRAPHY
Considered to be Part of the Data fi
Supporting R
28
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GUIDE "TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere in
the 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 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
V f w
by Master Record Identifier, or "MRID Number". This number is unique to the citation,
and should be used whenever a specific reference is required. It is not related to the six-
digit "Accession Number" which has been used to identify volumes of submitted studies (see
paragraph 4(d)(4) below for further explanation). In a few cases, entries added to the
bibliography late in the review may be preceded by a nine character temporary identifying
number which is also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material submitted
to EPA, by a description of the earliest known submission. Bibliographic conventions used
reflect the standard of the American National Standards Institute (ANSI), expanded to
provide for certain special needs.
a. Author. Whenever the author could confidently be identified, the Agency has chosen
to show a personal author. When no individual was identified, the Agency has shown
a identifiable laboratory or testing facility as the author. When no author or laboratory
could be identified, the Agency has shown the first submitter as the author.
b. Document Date. The date of the study is taken directly from the document. When the
date is followed by a question mark, the bibliographer has deduced the date from the
evidence contained in the document. When the date appears as (19??), the Agency was
unable to determine or estimate the date of the document.
29
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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 jpermit number, petition
number, or other administrative number associated with the earnest known
submission.
(3)
(4)
Submitter. The third element is the submitter. When authorship is de-faulted to
the submitter, ti% element is omitted.
Volume Identification ( Accession Numbers'}. The final! element in the trailing
parentheses identifies the EPA accession number of ttie volume in which the
original submission of ithe 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.
30
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BIBLIOGRAPHY
PRODUCT CHEMISTRY BIBLIOGRAPHY
42517401 Lawson, P. (1992) Product Identity and Composition for
10,10'-Oxybis-10-H-Phenoxarsine (OBPA). Unpublished study prepared by Akzo
Chemicals Inc. 24 p.
42517402 Clark, A. (1992) Physical and Chemical Characteristics Testing For
10,10'-Oxybis-10-H-Phenoxarsine (OBPA): Guideline 62: Lab Project Number
0922-042: 3130-F(02). Unpublished study prepared by Midwest Research
Institute. 75 p.
42517403 Clark, A. (1992) Physical and Chemical Characteristics Testing for
10,10'-Oxybis-10-H-Phenoxarsine (OBPA): Guideline 63: Lab Project Number
0922-042: 3130-F(01). Unpublished study prepared by Midwest Research
Institute. 50 p.
ECOLOGICAL EFFECTS BIBLIOGRAPHY
00013611 WARF Institute, Incorporated (1973) Report: WARF No. 3031960. (Unpublished
study received May 31, 1973 under 2829-96; sub-mitted by Ventron Corp.,
Beverly, Mass.; CDL:006984-D)
00013641 Bentley, R.E. (1976) Acute Toxicity of Vimyzene [sic] SB-1 to Blue-gill
(JJL ~ Lepomis macrochirus/i - ) and Rainbow Trout 0* Salmo p ~gairdneri/t ~).
(Unpublished study received Feb 5, 1976 under 2829-115; prepared by EG&G,
Bionomics, submitted by Ventron Corp., Beverly, Mass.; CDL:226171-V)
00013648 Fink, R. (1976) Final Report: Eight-Day Dietary LC=5(T-Bobwhite Quail:
Project No. 121-105. (Unpublished study received on un-known date under
2829-115; prepared by Truslow Farms, Inc. in cooperation with Maryland, Dept.
of Agriculture, Div. of Inspection and Regulation, submitted by Ventron Corp.,
Beverly, Mass.; CDL:228092-A)
00013649 Fink, R. (1976) Final Report: Acute Oral LD=5
-------
00030656 Heitmuller, T. (1979) Acute Toxicity of 10,10'-Oxybi5phenoxarsine (OBPA) to
Grass Shrimp (~Palaemonetespugio~M): Report No. BP-79-11-167.
(Unpublished study received May 29,1980 under unknown admin, no.; prepared
by EG&G, Bionomics, submitted by Thiokol Corp., Ventron Div., Danvers,
Mass.; CDL:242904-A)
00030657 Browne, A.M. (1980) Hie Acute Toxicity of lO^O'-Cxybisphenoxarsine to the
Water Flea-Daphnia-magna-Straus: UCES Project No. 11507-57-02.
(Unpublished study received May 29,1980 under unknown admin, no.; prepared
by Union Carbide Corp., submitted by Thiokol Corp., Ventron Div., Danvers,
Mass.;CDL:242904-D)
00030658 Heitmuller, T. (1980) Acute Toxicity of OBPA (10,10 -Oxybisphenoxarsine) to
Sheepshead Minnows (p - Cyprinodon - variegatus - p): Report No. BP-80-2-30.
(Unpublished study received May 29,1980 under unknown admin, no.; prepared
by EG&G, Bionomics, submitted by Thiokol Corp., Ventron Div., Danvers,
Mass.; CDL:242904-B)
GSO44009 Buccafusco, RJ. (1977) Acute Toxicity of OBPA to Bluegill and Rainbow Trout.
(Unpublished study prepared by EG and G Bionomics)
GS044067 Lee, T. and Regel, L. (1974) Fish Toxicity. Testing Report of WARP Institute,
No. 3121308.
00131955 Buccafusco, R. (1977) Acute Toxicity of 10, lO'-Oxybi'tphenoxarsine to Bluegill
(Lepomis macrochirus) and Rainbow Trout (Salmo gairdiieri). Unpublished study;
.100 p.
00147990 Regel, L. (1974) Fish Toxicity: WARF No. 312B08. Unpublished study
prepared by WARF Institute. 16 p.
TOXICOLOGICAL BIBLIOGRAPHY
00013643 Anspach, P.S. (1977) Acute Toxicity and Irritation Studies of 99.9%
10,10'-Oxybisphenoxarsine: 76-990-21. (Unpublished study received Feb. 16,
1977 under 2829-115; prepared by International Bio-Resuarch, Inc., submitted by
Ventron Corp., Beverly, Mass.; CDL:228087-B)
00013644 Brusick, D.J.; Weir, R. J. (1976) Mouse Lymphoma Mutagenicity Evaluation of
10,10'-Oxybisphenoxarsine: Final Report; LBI Project No. 2548. (Unpublished
study received Nov. 9,1976 under 2829-115; prepared ty Litton Bionetics, Inc.,
submitted by Ventron Corp., Beverly, Mass.; CDL:228088-A)
32
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00013647 Brusick, D.J.; Weir, R. J. (1976) Mutagenicity Evaluation of
10,10'-Oxybisphenoxarsine (Technical): Final Report; LBI Project No. 2547.
(Unpublished study received Jul. 15, 1976 under 2829-115; prepared by Litton
Bionetics, Inc., submitted by Ventron Corp., Beverly, Mass.; CDL:228091-A)
00013591 International Paint Company (1957?) Report on the Comparative Toxicology of
Phenarsazine oxide and Phenoxarsine oxide with Additional Data for the
Inhalation Toxicity of DM. (Unpublished study received Sep. 9, 1970 under
2693-21; CDL:105338-A)
00024935 Dow Chemical Company (1964) Toxicological Properties of
10,10'-Oxybisphenoxarsine. (Unpublished study received Nov. 2, 1964;
CDL:121914-A)
00024936 Fiantz, G.C.; Shrader, S.A. (1959) Results of a 35-day Dietary Feeding Study
of 10,10'-Oxybisphenoxarsine to Rats. (Unpublished study received Nov. 2,
1964; prepared by Dow Chemical Co. with Biochemical Research Laboratory;
CDL:121914-B)
00024937 Olson, K.J. (1959) Skin Contact-Irritation. (Unpublished study received Nov 2,
1964 under unknown udmin no.; prepared by Bio-chemical Research Laboratory,
submitted by ?; CDL:121914-C)
00024938 Olson, K.J. (1959) Bye Contact Test. (Unpublished study received Nov 2, 1964
under unknown admin, no.; prepared by Biochemical Research Laboratory,
submitted by ?; CDL:121914-D)
00024940 Oxen, F. (1959) Summary of Pathology on Male & Female Rats Fed
10,10'-Oxybisphenoxarsine in the Diet for 30 Days. (Unpublished study received
Sep.2, 1965; CDL:121914-G)
00024941 Olson, K.J. (1959) Acute Oral Toxicity. (Unpublished study received Nov 2,
1964 under unknown admin, no.; prepared by Bio-chemical Research Laboratory,
submitted by ?; CDL:121914-H)
00026092 Olson, K.J.; Nunemaker, R.B.; Shrader, S.A.; et al. (1959) Skin Contact
Absorption (Unpublished study received Nov. 2,1964; prepared by Biochemical
Research Laboratory with Dow Chemical Co., CDL:121914-F)
GS044002 Anspach, P.S. (1977) Acute Toxicity and Irritation Studies of OBPA (95.6%).
(Unpublished study prepared by Hill TopTesting Services, Inc.)
33
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GS044004 Babish, J.G. (1978) The Acute Dermal Toxicity (LDjo) of OBPA with Sprague-
Dawley Rats. (Unpublished study prepared by Food and Drag Research
Laboratories, Inc.)
GS044007 Bellies, R.P.; Makris, S.L. (1978) Teratology Study in Rats.
10,10'-Oxybisphenoxarsine: LBI Project No. 2081
-------
00131943 Thiokol Corp. (1976) [Study-Chemistry: Vinyzene]. (Compilation; unpublished
study received May 16, 1977 under unknown admin, no.; CDL:251349-A)
GS044011 Cadmus, E.L. (1973a) Extractability of Vinyzene BP-5, Laboratory Report
submitted by Ventron Corporation, Beverly, MA, Mar 30.
GS044012 Cadums, E.L. (1973b) Extractability of Vinyzene BP-10 from Light gauge
Plasticized Vinyl Film used as Baby Pants' Material, Laboratory Report submitted
by Ventron Corporation, Beverly, MA, Oct 1.
GS044023 Hamilton, N.F. (1978) Laboratory Report Evaluating the Diffusive Properties of
New Biocided ATV-129, C-10545, and RH-893 in Three Polymer Systems
Compared to OBPA. Test 78-49 Part I. (Unpublished study received? under an
unknown admin, no.; prepared by Ventron Corp., Beverley, MA)
GS044024 Hamilton, N.F. (1978) Efficacy Study of PVC Films Containing OBPA: Test 78-
49 Part IB. (Unpublished study received? under an unknown admin, no.;
prepared by Ventron Corp., Beverley, MA)
GS044030 Kirkpatrick, D. (1977a) Laboratory report on Silicons Sealant, sample no.
ED805-3082. (Unpublished report received ? under an unknown admin, no.;
prepared by the Consumer Protection Safety Commission; submitted by ?)
GS044034 Kugler, D.J. (1974) Arsenic Survey at Ventron Corp.
GS044048 Porter, W.K. (1973) U.S. Consumer Product Safety Commission's Analyst
Worksheet on G.E. Silicone sealer white, Nov. 11.
GS0440SS United States Department of Health, Education, and Wealfare (1962) Public
Health Service Drinking Water Standards, 1962. Public Health Service
Publication No. 956, Washington, DC, U.S. Government Printing Office.
GS0440S6 Ventron Corporation (1978) Extraction of 10,10'- Oxybisphenoxarsine from
Plasticized Vinyl Films.
GS044062 Weingast, J. (1976) Arsenic Survey at Ventron Corp.
GS044080 Aldous, K.M. (1977) Analysis of Silicone Caulking Compounds for Arsenic
Content. (Unpublished study prepared by the N. Y State Department of Health)
35
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APPENDIX D
TJgt of Available
36
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APPENDIX D
The following is a list of available documents related to Oxybisphenoxarsine (OBPA). Its
purpose is to provide a path to more detailed infonnation if it is required. These accompanying
documents are part of the Administrative Record for OBPA and are included in the EPA's Office
of Pesticide Programs Public Docket.
1. Health and Environmental Effects Science Chapters
2. Detailed Label Usage Infonnation System (LUIS) Report
3. OBPA RED Fact Sheet (included in this RED)
4. PR Notice 91-2 (Included in this RED) Pertains to the Label Ingredient Statement
Federal publications on OBPA are available and may be purchased from the National Technical
Infonnation Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161.
Guidance for the Reregistration of Pesticide Products Containing OBPA as the Active
Ingredient (The 1981 Registration Standard): NTIS Stock No. PB82-172271.
OBPA Data-Call-in (DO) of 9-30-91.
37
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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 policy with respect to the statement of
percentages in a pesticide's label's ingredient statement.
Specifically, the amount (percent by weight) of ingredient(s)
specified in the ingredient statement on the label must be stated
as the nominal concentration of such ingredient(s), as that term
is defined in 40 CFR 158.153(i). Accordingly, the Agency has
established the nominal concentration as the only acceptable
label claim for the amount of active ingredient in the product.
II. BACKGROUND
For some time the Agency has accepted two different methods
of identifying on the label what percentage is claimed for the
ingredient(s) contained in a pesticide. Some applicants claimed a
percentage which represented a level between the upper and the
lower certified limits. This was referred to as the nominal
concentration. Other applicants claimed the lower limit as the
percentage of the ingredient(s) that would be expected to be
present in their product at the end of the product's shelf-life.
Unfortunately, this led to a great deal of confusion among the
regulated industry, the regulators, and the consumers as to
exactly how much of a given ingredient was in a given product.
The Agency has established the nominal concentration as the only
acceptable label claim for the amount of active ingredient in the
product.
Current regulations require that the percentage listed in
the active ingredient statement be as precise as possible
reflecting good manufacturing practices 40 CFR 156.10(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).
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The upper and lower certified limits, which must be proposed in
connection with a product's registration, represent the amounts
of an ingredient that may legally be present 40 CFR 158.175. The
lower certified limit is used as the enforceable lower limit for
the product composition according to FIFRA section 12(a)(l)(C),
while the nominal concentration appearing on the label would be
the routinely achieved concentration used for calculation of
dosages and dilutions.
The nominal concentration would in fact state the greatest
degree of accuracy that is warranted with respect to actual
product composition because the nominal concentration would be
the amount of active ingredient typically found in the product.
It is important for registrants to note that certified
limits for active ingredients are not considered to be trade
secret information under FIFRA section 10 (b) . I:n 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)(l)(C).
III. REQUIREMENTS
As described below under Unit V. " COMPLIANCE SCHEDULE," all
currently registered products as well as all applications for new
registration must comply with this Notice by specifying the
nominal concentration expressed as a percentage by weight as the
label claim in the ingredient(s) statement and equivalence
statements if applicable (e.g., elemental arsen:.c, metallic zinc,
salt of an acid). In addition, the requirement l:or performing
sample analyses of five or more representative samples must be
fulfilled. Copies of the raw analytical data rous;t be submitted
with the nominal ingredient label claim. Further information
about the analysis requirement may be found in the 40 CFR
158.170. All products are required to provide certified limits
for each active, inert ingredient, impurities of toxicological
significance (i.e., upper limit(s) only) and on ei case by case
basis as specified by EPA. These limits are to be set based on
representative sampling and chemical analysis(i.e., quality
control) of the product.
The format of the ingredient statement must conform to 40
CFR 156-Labeling Requirements For Pesticides and. Devices.
After July 1, 1997, all pesticide ingredient Statements must
be changed to nominal concentration.
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IV. PRODUCTS THAT REQUIRE EFFICACY DATA
All pesticides are required to be efficacious. Therefore,
the certified lower limits may not be lower then the minimum
level to achieve efficacy. This is extremely important for
products which are intended to control pests which threaten the
public health, e.g., certain antimicrobial and rodenticide
products. Refer to 40 CFR 153.640.
In those cases where efficacy limits have been established,
the Agency will not accept certified lower limits which are below
that level for the shelf life of the product.
V. COMPLIANCE SCHEDULE
As described earlier, the purpose of this Notice is to make
the registration process more uniform and more manageable for
both the agency and the regulated community. It is the Agency's
intention to implement the requirements of this notice as
smoothly as possible so as not to disrupt or delay the Agency's
high priority programs, i.e., reregistration, new chemical, or
fast track (FIFRA section 3(c)(3)(B). Therefore,
applicants/registrants are expected to comply with the
requirements of this Notice as follows:
(1) Beginning July 1, 1991, all new product registrations
submitted to the Agency are to comply with the
requirements of this Notice.
(2) Registrants having products subject to reregistration
under FIFRA section 4(a) are to comply with the
requirements of this Notice when specific products are
called in by the Agency under Phase V of the
Reregistration Program.
(3) All other products/applications that are not subject to
(1) and (2) above will have until July 1, 1997, to
comply with this Notice. Such applications should note
"Conversion to Nominal Concentrations on the
application form. These types 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) 557-5024
Ann« S. tindaay, Director
Registration Division (Ji-7505
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APPENDIX E
Pesticide RencktratRm Handbook
38
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United Stales Office of October 1991
Environmental Protection Pesticide Programs
Agency ^
Pesticide
Reregistration
Handbook
How to Respond to
the Reregistration
Eligibility Document
(RED)
Printed on Recycled Paper
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PESTICIDE RERBGISTRATION HANDBOOK
HOW TO RESPOND TO THE
REREGISTRATION ELIGIBILITY DOCUMENT (RED)
OFFICE OF PESTICIDE PROGRAMS
ENVIRONMENTAL PROTECTION AGENCY
OCTOBER 1991
Printed on Recycled Paper
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PRODUCT REREGI8TRATION EAHDBOOK
TABLE OP CONTENTS
I. Introduction
A. Purpose and Content
B. Reregistration Eligibility Document
C. Reregistration Process
II. Instructions for Responding
A. How and When to Respond
B. mien No Response Is Needed
B. Where to Respond
III. Submission of Data and Labels/Labeling
A. Generic Data
B. Product Specific Data
1. Product Chemistry
2. Acute Toxicity
3. Product Performance
C. Labels/Labeling
Appendix
A. Confidential statement of Formula and Instructions
B. Label Contents
C. Sample Label FormatsGeneral Use & Restricted Use
D. Label Regulations (40 CFR 156.10)
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PESTICIDE REREGISTRATION HANDBOOK
I. INTRODUCTION
A. Purpose and Content of this HflP^fo?PK
This Handbook provides instructions to registrants on how to
respond to the Reregistration Eligibility Document (hereafter
referred to as the "RED") and how to reregister products.
Section I is this introduction.
Section XI contains step-by-step instructions which must be
followed by registrants responding to the RED.
Section III provides additional instructions on the format,
content and other aspects of generic data, product specific data
and labels/labeling which may be required to be submitted.
Detailed instructions are in the Appendix.
B. The Rereoistration Eligibility Pocu.rn.ent (RED)
Under Section 4 of the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA), as amended in 1988, EPA is required to
reregister pesticides that were first registered before November 1,
1984. The RED describes in detail the subject chemical, its uses
and its regulatory history; describes EPA's decision concerning the
eligibility of the uses of the chemical for reregistration; and
explains the scientific and regulatory bases for this decision.
EPA's reviews of the data by scientific discipline are available
upon request. Appendices to the RED contain: (1) a Data Dall-In
Notice which requires submission of generic and product specific
data and which gives directions for responding, (2) a listing of
existing studies that satisfy generic data requirements and (3) a
bibliography of the generic studies EPA has reviewed.
C. The Rereoistration Process
Reregistration involves a thorough review of the scientific
data base underlying a pesticide's registration. The purpose of
EPA's review is to reassess the potential hazards arising from the
currently registered uses of the pesticide, to determine whether
the data base is substantially complete or there is need for
additional generic data, and to determine whether the pesticide is
eligible for reregistration. This decision is issued as the RED.
EPA's science reviews and information on the registered
uses considered for EPA's analyses may be obtained from: EPA,
Freedom of Information, 401 M St., S.W., Washington, D.C. 20460.
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If the RED declares that some or all uses of the chemical are
eligible for reregistration, affected registrants must first
respond within 90 days of receipt to the data call-in portion of
the RED. Within 8 months of receiving the REE', registrants must
submit or cite any data and labels/labeling required for each
product. EPA has until 14 months after the RED is issued .(i.e.r
6 months after the registrants* 8 month deadline) to review the
submission for each product and decide whether to reregister it
based on the 'following criteria:
--whether all of the product specific data and labels/labeling
are acceptable,
--whether all of the uses on the label/labeling are eligible,
whether all of the active ingredients ir. the product are
eligible, and
if no List 1 toxic inert ingredient is contained in the
product (a List 1 inert is permitted only if all data
for it have been submitted and EPA determines
that the inert does not pose any unreasonable adverse
effects in that product).
Products which meet all of these criteria will be
reregistered. Products which do not meet all of these criteria,
but which have acceptable product specific data and labeling, will
be processed as amendments in order to implement label changes
required by the RED..
II. INSTRUCTIONS FOR RESPONDING
A. How and When to Respond
This section provides directions for submitting timely and
adequate responses necessary to reregister products containing the
active ingredient covered by the RED. Registrants must follow
these steps exactly to avoid suspension of their products. All
products containing the active ingredient in the RED [i.e.,
manufacturing use products, end use products and special local need
(8LK or Section 24c) registrations] are subject to the requirements
of the RED. Figure 1 summarizes how and when to respond to the
RED. A step-by-step explanation follows.
Step 1. Are Expedited Label Chances Reciuired? In some
instances, EPA may conclude that certain changes to product
labels/labeling must be implemented rapidly. I:C the RED requires
expedited label/labeling changes, registrants muiit submit the items
below by the deadline specified in the RED. If expedited label
changes are not required, go to Step 2.
a. Application for Registration (EPA Form 8570-1). Complete
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and sign the form. In Section II, insert the phrase "Expedited
Amendment in Response to the Reregistration Eligibility Document
for (insert ease name for chemical).11 Applications for expedited
label changes will be processed as applications for amended
registration. Use only an original application form with a red
identifier number in the upper right-hand corner.
b. rive (5) copies of revised draft label and labeling.
Refer to the RED for label/labeling changes. and follow the
instructions in Section III.C. and the Appendix of this Handbook
for revising the label and labeling for each product.
step 2. Are data required? If the RED requires generic or
product specific data, you must follow the directions in the data
call-in notice in the RED. All registrants Bust respond for all
products within »o davs of receipt; products for which an adequate
response is not received on time will be subject to suspension. He
time extensions will be given for responding within 90 davs.
Step 3. Are Uses of a Pesticide Eligible for Rereai strati on?
If any uses of the active ingredient (s) covered by the RED are
eligible for reregistration, follow these instructions. If no uses
are eligible, no further response may be needed (see page 5).
EPA's decision on the eligibility of each of the uses of the
active ingredient (s) is presented in the RED. If any uses of a
chemical are eligible for reregistrationt registrants for
manufacturing-use products (MPs), end-use products (EPs) and
special local needs registrations (SLNs), must submit the items
below for each product within e months of the date of issuance of
the RED:
a. Application for Reregistration (use EPA Form 8570-1).
Complete and sign the form. In Section II of that form, check the
box "Other" and insert the phrase "Application for Reregistration.*1
Use only an original application form with a red identifier number
.in the upper right-hand corner.
b. Five (5) copies of revised draft label and labeling.
Refer to the RED for labeling changes specific to the active
ingredient, follow the instructions in Section III.C. of this
Handbook and refer to the Appendix of this Handbook for guidance on
current requirements for labels and labeling. If there are
ineligible uses on the label or labeling, you may delete such uses
and avoid all requirements and consequences which may be associated
with ineligible uses (e.g, generic data requirements, cancellation,
suspension, etc.). If you delete certain uses now and those uses
become eligible for reregistration later, you must submit an
amendment application to add those uses back to the label.
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FIGURE 1. BOW AND VEEN TO RESPOND TO TEE REREGISTRATION
ELIGIBILITY DOCUMENT (RED) TOR MANUFACTURING USE
PRODUCTS (KPs), END-USE PRODUCTS (EPS) and SPECIAL
LOCAL NEEDS REGISTRATIONS (SLNs).
STEP it Are expedited label revisions required?
Yes S\ NO
Submit application
and labels on
expedited schedule
specified in RED.
STEP 2s Are data required?
Yes ^ No
r
Submit forms within
90 days for generic
and product specific
data.
STEP 3i
Are any of the uses on the label
eligible for reregistration?
Yes
Are any uses on the label
ineligible for reregistration?
Yes
Do you vish to
delete ineligible
uses from label?
For each HP t EP
fi SLN (24c) submit
application within
8 months, if
the submission
is acceptable,
the label will be
stamped accepted
as an amendment.
Ma reregistration
vill be issued.
No
Yes
For each HP c EP
& SLN (24c) submit
application vithin
* months. If
the submission
is acceptable,
the label vill be
stamped accepted
and a notice of
reregistration
vill be issued.
No further response
necessary. Await
the outcome of
EPA's review.
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c. Product Specific Data. Yon must follow the instructions
in thf Data Call-in Notice in the RED and in Section III of this
Handbook. Responses to th« data call in art due within »o davs of
receipt of the RED and submission or citation of data is due within
8 Months of the issuance of the RED.
d. Two (2) copies of the current confidential statement of
Formula (EPA Form 8570-4, revised February 85). Two completed and
signed CSF forms must be submitted for the basic formulation and
for each alternate formulation. If CSFs are not provided for the'
alternate formulas, they will not be reregistered and will no
longer be acceptable. The Appendix of this Handbook has specific
instructions for completing the CSF form.
e. Certification with Respect to Citation of Data (EPA Form
8570-31). This form must be completed, signed and submitted for
each product to assure that the data compensation provisions of
FIFRA are met.
B. When No Response is Needed
If no uses of a pesticide are eligible for reregistration, it
is unlikely that you will be required to submit product specific
data or labeling. Uses of an active ingredient may be declared
ineligible for reregistration for two possible reasons:
Available data indicate that one or more of the criteria for
an in-depth special review have been met;
Additional generic data are required.
In the first instance, if the active ingredient is placed into
special review, reregistration activities associated with those
uses of the chemical are stopped until EPA makes a final
determination. At that time, EPA will indicate which uses may be
eligible for reregistration and which uses are to be cancelled. If
some or all of the previously ineligible uses become eligible for
reregistration, EPA will start the reregistration process for
products containing only eligible uses.
In the second instance, based upon the review of studies for
an active ingredient during reregistration, additional generic data
(e.g., second- or third-tier studies) may be needed (see the RED).
In such cases, the chemical's uses will not be eligible for
reregistration until the additional generic data have been
submitted to and reviewed and found acceptable by EPA. If the data
are reviewed and found to be acceptable, EPA will indicate which
uses will be eligible for reregistration and will initiate
reregistration of products containing previously ineligible uses.
If the data are not submitted, products containing the active
ingredient may be suspended.
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C. Where to Respond
By U.S. Mail:
Document Processing Desk (insert distribution code)
Office of Pesticide Programs (H7504C)
Environmental Protection Agency
401 M Street, S.W.
Washington, D.C. 20460-0001
By express mail or by hand delivery:
Document Processing Desk (insert distribution code)
Office of Pesticide Programs (H7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Highway
Arlington, VA 22202
These mailing addresses and the following distribution codes
aust be used to assure the timely receipt and processing of your
submissions. Not using them may significantly delay the handling
of your submissions:
RED-SRRD-xxx (where JQDC is the case code given on the front of
the RED)use this distribution code for all responses pertaining
to or containing generic data. Such responses include the 90-day
response forms for generic data or hard copies of generic data.
RED-RD-PMxx (where xx is the Product Manager team number)
use this distribution code for all responses pertaining to or
containing product specific data or labeling. Such responses would
include expedited labeling amendments, 90-day responses to product
specific data requirements, hard copies of product specific data
and applications for reregistration.
III. SUBMISSION OF DATA AND LABELS/LABELING
This section provides additional instructions concerning
responses required for generic data, product specific data and
labels/labeling.
A. Generic Data
During EPA's evaluation of an active ingredient for
reregistration, additional generic data requirements may be
identified that registrants must fulfill. In some instances these
data requirements would have to be satisfied before an active
ingredient or some of its uses could be declared eligible for
reregistration. In other cases, these new data requirements would
not affect the eligibility of the active ingredient, but would be
necessary to confirm EPA's assessment of that chemical.
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Any new data requirements and how they affect reregistration
eligibility of a chemical are discussed in the RED. If new generic
data requirements are imposed in a Data Dall-In Notice in the RED,
registrants must respond as described in that Notice. The RED also
contains instructions for completing these foi-ms, a citation of
EPA's legal authority for requiring the new data, a listing of
options available to registrants for satisfying the data
requirements and the name of the contact person for inquiries.
B. Product Specific Data
Product specific data may be required for the reregistration
of each pesticide product in three areasproduct chemistry, acute
toxicity and efficacy.
1. Product chemistry
Following are instructions for submitting product-specific
data and a discussion of EPA's policy on inert ingredients.
a. Data
All data requirements for MPs, EPs and SLNs (24c's) are
specified in the Data Call-In Notice in the RED. In addition:
--If you cite data from another identical, registered
product, you must identify the EPA registration number of that
product.
If the product-specific data submitted or cited do not
pertain to an identical formulation to the product submitted for
reregistration, then new product-specific data are required to be
submitted by the deadline specified in the Data Call-in Notice.
The only exception is for products which EPA "groups" together a
being similar enough to depend on the same date. Such groupings
are discussed in the appendix to the RED (for acute toxicity
purposes, for example), if it was feasible to do so.
b. Inert Ingredients
EPA has implemented a strategy for regulating inert
ingredients which affects the reregistration of pesticide products.
This strategy, issued on April 22, 1987 (52 FP 13305-13309) and
updated on November 22, 1989 (54 FR 48314-48316], adopted certain
policies designed to reduce the potential for adverse effects from
pesticide products containing intentionally added inert
ingredients. EPA divided the known inert ingredients into four
categories:
Inerts of toxicological concern (List 1) for which available
data demonstrate toxic effects of concern (includes about 50
chemicals).
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Potentially toxic inerts (List 2) for which only limited
data are available, but such data or the chemical structure suggest
the potential for toxicity (includes about 60 chemicals).
Inerts of unknown toxicity (List 3) for which no data or
bases for suspecting toxic effects are available (includes up to
2,000 chemicals).
Inerts of minimal concern (List 4) which are generally
regarded as innocuous (includes about 290 chemicals).
When a RED is issued and any uses of an active ingredient are
declared eligible for reregistration, all products containing that
active ingredient will be subject to reregistration. EPA will, as
part of the reregistration review, examine the inert ingredients of
each product prior to reregistration to ensure that they do not
present unreasonable risks. In reviewing the product chemistry
data, EPA will identify List 1 inerts. EPA will continue to
encourage registrants to eliminate any List 1 inerts present.
Reregistration of products containing only List 2, 3 or 4 inerts
will be unaffected by the inerts strategy.
Consistent with the strategy on inerts, a product containing
a List l inert ingredient will not be reregistered until a full
risk assessment of the product has been conducted, based on the
data called in for that inert ingredient. However, the existing
registration of a product containing a List 1 inert will remain
valid as long as the product bears the required label warning and
is in compliance with any outstanding DCI, or other activity under
the inerts strategy.
Any product containing a List 2, 3 or 4 inert mav be
reregistered if it meets all other requirements for reregistration.
As the inerts strategy is implemented and data for the List 2 and
3 inerts are reviewed, EPA may move these inerts to the other
Lists. If an inert were moved to List 1, products containing that
inert would become ineligible for reregistration. Inert
ingredients must also meet normal registration and tolerance
requirements, as applicable.
2. Acute Toxicitv
The data call-in notice in the RED specifies the acute
toxicity data required for reregistration of each HP or EP. It
indicates whether any of the standard tests have been waived and,
if so, why.
If feasible, EPA will "batch" products that are similar with
respect to their acute toxicity so that one set of tests can
support reregistration of each baatch of products. This approach
will impose the least amount of testing necessary to adequately
support the registration and labeling for pesticide products. The
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main benefits of this approach are to minimize ithe need for animal
testing, reduce the expense to registrants to generate the tests
and decrease the resources EPA must spend on reviewing data.
Registrants may contact other registrants with products in the same
"batch*1 to decide whether to provide or depend on one set of data;
alternatively, registrants may choose to conduct their own studies.
3. Product Performance
Consult the Data Call-In section of the RED to determine
whether Product Performance data are required for your product.
Product performance (efficacy) data are generated in studies
designed to document how candidate pesticide formulations perform
as pest control agents. These data include tests run to determine
whether a formulation is lethal to certain pest species, to
document the effectiveness of the formulation in controlling pest
species in actual use situations, and to determine whether certain
claims beyond mere control of a pest (e.g., "six-month residual
effect," "kills Warfarin resistant house mice," etc.) are
justified.
EPA has standard protocols for certain isfficacy tests. In
general, standard methods have been developed for tests needed to
substantiate claims that have been made frequently for pesticide
products. As the scope of potential pesticidal claims is extremely
broad, the Agency does not have standard methods for tests needed
to substantiate many pesticide claims, especially those that are
uncommon. The Product Performance Guidelines, Subdivision 6, offer
general guidance for developing protocols for efficacy testing.
Proposed protocols should be submitted to EPA for review before
tests are initiated.
a. Efficacy Data Submission Waiver Policy
FIFRA gives the Administrator of EPA authority "to waive data
requirements pertaining to efficacy" but does not require that
efficacy data requirements be waived for any class of pesticide
product registered under Section 3 of the Act. As a matter of
policy, EPA does not require submission of efficacy data to support
many types of pesticidal claims but does require submission of such
data for certain types of claims. As noted in 40 CFR 158.640, this
waiver applies to the submission of efficacy data rather than to
the generation of efficacy data. EPA expects each registrant to
"ensure through testing that his products are efficacious when used
in accordance with commonly accepted pest control practices."
This general policy notwithstanding, EPA may, at any time,
require a registrant to submit efficacy data to support any claim
made for a product. EPA also may require that certain claims of
effectiveness be established before a Section 3 registration is
granted.
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b. Claims and Products for Which Efficacy Data
Are Required
Submission of efficacy data at reregistration typically is
required for the following types of products:
l. products claimed to control microorganisms that
pose potential threats to public health;
2. products claimed to control vertebrate pests that
may directly or indirectly transmit diseases to
humans ;
3. potentially very hazardous products for which EPA
determines that it is necessary to conduct a "risk-
benefits" analysis;
4. products of types for which EPA has reasons (e.g.,
consumer complaints, unlikely claims, unusual use
patterns, etc.) to question claims; and
&
C. Labels and Labeling
To remain in compliance with FIFRA, the label and' labeling of
each product must be revised to meet the requirements for
reregistration as described below. "Labeling" includes the
container label and -any written, printed or graphic matter that
accompanies the pesticide in U.S. commerce at any time (such as
technical bulletins, collateral labeling, etc.). Applications for
aev uses or labeling changes that do not pertain to reregistratios
must be filed separately from the application for reregistration
described in Step 3 earlier. Changes to labeling which must be
made for reregistration include, but are not limited to:
1. Labeling changes specified in the RED. Such changes may
include statements on RESTRICTED USE, groundwater hazards,
protective clothing/equipment, endangered species, environmental
hazards, etc.
2. The format and content of labeling as described in 40 CFR
156.10. When further acute testing is needed, the currently
accepted precautionary statements will usually be retained until
testing is completed and the data are reviewed.
3. Labeling changes required -by Pesticide Regulatory (PR)
Notices, regulations, regulatory decisions and policies issued by
EPA which are relevant to the pesticide. Your product's labeling
must reflect any applicable requirements which are in effect at the
time the RED is issued. Some existing notices are referred to in
Section B. of the Appendix.
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APPENDIX
A. Confidential Statement of Formula and Instructions
B. Instructions for Label Contents
C. Sample Label FormatsGeneral Use & Restricted Use
D. Label Regulations (40 CFR 156.10)
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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 grains. 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 all active and
inert ingredients must follow the 40 CFR 158.175 instructions. An
explanation must be provided if the proposed limits are different
than standard certified limits.
n. When new CSFs are submitted and approved, all previously
submitted CSFs become obsolete for that specific formulation.
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B. INSTRUCTIONS FOR IABEL CONTENTS
40 CFR 156.10 and Pesticide Regulatory (P.R.) Notices require
that specific labeling statements appear at certain locations on
the label. The sample label formats in Appendix C show where these
statements are to be placed.
Item 1. PRODUCT NAME - The name, brand or trademark is required to
be located on the front panel, preferably centered in the upper
part of the panel. The name of a product will not be accepted if
it is false or misleading. [40 CFR 156.10(b)]
Item 2. COMPANY NAME AND ADDRESS * The name and address of the
producer, registrant or person for whom the product is produced are
required on the label and should be located at the bottom of the
front panel or at the end of the label text. [40 CFR 156.10(c)]
Item 3. NET CONTENTS - A net contents statement is required on all
labels or on the container of the pesticide. The preferred
location is the bottom of the front panel immediately above the
company name and address, or at the end of the label text. The net
contents must be expressed in the largest suitable unit, e.g., "1
pound 10 ounces" rather than "26 ounces." In addition to English
units, net contents may be expressed in metric units. [40 CFR
156.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration number assigned
to the pesticide product must appear on the label, preceded by the
phrase "EPA Registration No.," or "EPA Reg. No." The registration
number must be set in type of a size and style similar to other
print on that part of the label on which it appears and must run
parallel to it. The registration number and the required
identifying phrase must not appear in such a manner as to suggest
or imply recommendation or endorsement of the product by the
Agency. [40 CFR 156.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment number,
preceded by the phrase "EPA Est." is the final establishment at
which the product was produced, and may appear in any suitable
location on the label or immediate container. It must also appear
on the wrapper or outside container of the package if the EPA
establishment number on the immediate container cannot be clearly
read through such wrapper or container. [40 CFR 156.10(f)]
Item 6A. INGREDIENTS STATEMENT - An ingredients statement is
normally required on the front panel. The ingredients statement
must contain the name and percentage by weight of each active
ingredient and the total percentage by weight of all inert
ingredients. The preferred location is immediately below the
product name. The ingredients statement must run parallel with,
and be clearly distinguished from, other text on the panel. It
must not be placed in the body of other text. [40 CFR 156.10(g)]
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricultural
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formulations, the pounds per gallon of active ingredient must be
indicated on the label. [40 CFR 156.10(h)(iv)]
Item 6C. NAMES TO BE USED IN INGREDIENT STATEMENT - The acceptable
common name, if there is one, shall be used, followed by the
chemical name. If no common name has been established, the
chemical name alone shall be used. Chemicals related to the active
ingredient are allowed, to be listed enlv if efficacy data
supporting such claims are submitted or referenced. If such data
are provided, the related chemicals must be lilted separately and
not as a portion of the active ingredient.
Item 6D. INERT INGREDIENTS RECLASSIFIED AS ACTPTE INGREDIENTS -If
EPA has reclassified chemicals from inert inerredient status to
active ingredient status, registrants of affe
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Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal, or
inhalation toxic ity, the word "Poison" shall appear on the label in
red on a background of distinctly contrasting color and the skull
and crossbones shall appear in immediate proximity to the word
POISON. [40 CFR 156.10(h)(1)(i)].
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement of
practical treatment (first aid or other) shall appear on the label
of pesticide products in toxicity Categories I, II, and III. [40
CFR 156.10(h) (1) (iii) ]
Item 7E. REFERRAL STATEMENT - The statement "see Side (or Back)
Panel for Additional Precautionary Statements" is required on the
front panel for all products, unless all required precautionary
statements appear on the front panel. [40 CFR 156.10(h) (1) (iii)].
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The precautionary
statements listed below must appear together on the label under the
heading "PRECAUTIONARY STATEMENTS." The preferred location is at
the top of the side or back panel preceding the directions for use,
and it is preferred that these statements be surrounded by a block
outline. Each of the three hazard warning statements must be
headed by the appropriate hazard title. [40 CFR 156.10(h)(2)]
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a hazard
exists to humans or domestic animals, precautionary statements are
required indicating the particular hazard, the route(s) of exposure
and the precautions to be taken to avoid accident, injury or
damage. [40 CFR 156.10(h)(2)(i)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to non-
target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of the
hazard and the appropriate precautions to avoid potential accident,
injury, or damage. [40 CFR 156.lO(h)(2)(ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY Precautionary
statements relating to flammability of a product are required to
appear on the label if it meets the criteria in the PHYS/CHEM
Labeling Appendix. The requirement is based on the results of the
flashpoint determinations and flame extension tests required to be
submitted for all products. These statements are to be located in
the side/back panel precautionary statements section, preceded by
the heading "Physical/Chemical Hazards." Note that no signal word
is used in conjunction with the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3 (d) requires
that all pesticide formulations/uses be classified for either
general or restricted use. Products classified for restricted use
may be limited to use by certified applicators or persons under
their direct supervision (or may be subject to other restrictions
that may be imposed by regulation). If your product has been
classified for restricted use, then these requirements apply:
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1. All uses restricted. The following statements must be placed
in a black box at the top of the front panel of the label and
labeling:
a. The statement "Restricted Use Pesticide" must appear at
the top of the front panel of the label. The statement
must be set in type of the same minimum size as required
for human hazard signal word [see table in 40 CFR
156.10(h)(1)(iv)]. No statements of any kind may appear
above this RUP statement.
b. The reason .for the the restricted use classification must
appear below the RUP statement. The RED will prescribe
this statement.
c. A summary statement of the terms of restriction must
appear directly below this reason statement on the front
panel. If use is restricted to certified applicators,
the following statement is required: "For retail sale to
and use only by Certified Applicators or persons under
their direct supervision and only for those uses covered
by the Certified Applicator's Certification." The RED
will specify what statement must be used.
2. Some but not all uses restricted. If the RED states that some
uses are classified for restricted use, and some are
unclassified, several courses of action are available:
a. You may label the product for Restricted use. If you do
so, you may include on the label uses that are
unrestricted, but you may not distinguish them on the
label as being unrestricted.
b. You may delete all restricted uses from your label and
submit draft labeling bearing only unrestricted uses.
c. You may "split" your registration, i.e., register two
separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted
simultaneously. Note that the products will be assigned
separate registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the misuse
statement, "It is a violation of Federal law to use this product in
a manner inconsistent with its labeling." This statement appears
at the beginning of the directions for use, directly beneath the
heading of that section.
Item 10A. REENTRY STATEMENT - If a restricted entry interval (REI)
has been established by the Agency, it must be included on the
label. Additional worker protection statements may be required in
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accordance with PR Notice 83-2, March 29, 1983.
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are required to
bear storage and disposal statements. These statements are
developed for specific containers, sizes, and chemical content.
These instructions must be grouped and appear under the heading
"Storage and Disposal" in the directions for use. This heading
must be set in the same type sizes as required for the child hazard
warning. Refer to P.R. Notices 83-3 and 84-]. to determine the
storage and disposal instructions appropriate for your products.
Item IOC. DIRECTIONS FOR USE - Directions for use must be stated
in terms which can be easily read and understood by the average
person likely to use or to supervise the use of the pesticide.
When followed, directions must be adequate to protect the public
from fraud and from personal injury and to prevent unreasonable
adverse effects on the environment. [40 CFR 156.10(i)(2)]
COLLATERAL LABELING .
Bulletins, leaflets, circulars, brochures, data sheets, flyers, or
other written or graphic printed matter which is referred to on the
label or which is to accompany the product are termed collateral
labeling. Such labeling may not bear claims or representations
that differ in substance from those accepted :Ln connection with
registration of the product. Collateral labeling must be made part
of the response to the RED and submitted for review.
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LABEL FORMAT FOR UNCLASSIFIED PRODUCTS
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LABEL FORMAT FOR PRODUCTS CLASSIFIED FOR RESTRICTED USE
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§nvlf»i«"»nt With respect to a Registration
Standard for which the Agency has
determined that a substantially com-
plete chronic health and teratology
data base exists, a copy of the FEDERAL
REGISTER notice concerning availabil-
ity of a proposed Registration Stand-
ard. and a copy of each comment re-
ceived in response to that notice
(within 10 working days after receipt
by the Agency, or 15 working days If
the submitter has asserted a confiden-
tial business information gi*< con-
cerning the material).
(8) A copy of the FEDERAL REGISTER
notice announcing the issuance of the
Registration Standard (within 10
working days after the publication of
the notice).
(c) Index of the docket The Agency
will establish and keep current an
index to the docket for each Registra-
tion Standard. The index will include.
but is not limited to:
(1) A list of each meeting between
the Agency and any person or party
outside of government, containing the
date and subject of the meeting, the
names of participants and the name of
the person requesting the meeting.
(2) A list of each document in the
docket by title, source or recipient^),
and the date the document was re-
ceived or provided by the Agency.
(d) Availability of docket and indi-
ces (1) The Agency wQl make avail-
able to the public for inspection and
copying the docket and index for any
Registration Standard.
(2) The Agency will establish and
of persons who
§156.10
these persons. Annually. EPA will re-
quire that persons on the list renew
their requests for inclusion on the list.
(3) The Agency will issue mm»iiy m
the FEDERAL REGISTER (in conjunction
with the annual schedule notice speci-
fied in 1155.25) a notice announcing
the availability of docket indices.
(4) Each FEDERAL REGISTER notice of
availability of a Registration Standard
will announce the availability of the
docket index for that Standard.
165J4 Notice of availability.
(a) The Agency will issue in the FED-
ERAL REGISTER a notice announcing the
issuance and availability of Registra-
tion Standard which:
(1) Concerns a previously unregis-
tered active ingredient: or
(2) Concerns a previously registered
active ingredient, and the Registration
Standard states that registrants will
be required (under FIFRA section
3(cX2XB» to submit chronic health
(Including, but not limited to. chronic
feeding, oncogenidty and reproduc-
tion) or teratology studies.
(b) Interested persons may submit
comments concerning any Registra-
tion Standard described by paragraph
(a) of this section at any time.
(c) The Agency will issue in the FED-
ERAL REGISTER a notice announcing the
availability of. and providing opportu-
nity for comment on, each proposed
Registration Standard which concerns
a previously registered active ingredi-
ent for which the Agency has deter-
mined that a substantially complete
chronic health and teratology data
base exists. Following the comment
period and issuance of the Registra-
tion Standard, the Agency will issue in
the FEDERAL REGISTER a notice of avail-
ability of the Registration Standard.
PART 156LABELING REQUIRE-
MENTS FOR PESTICIDES AND DE-
have specifically requested that they
receive indices for Registration Stand-
ard dockets. On a quarterly basis. EPA
will distribute the indices of new mate-
rials placed in the public docket to
AUTBOUTT: 7 T7B.C. U6-136y.
1166.10 Labeling requirement*.
(a) General(1) Content* of the
label Every pesticide products shall
bear a label containing the informa-
tion specified by the Act and the regu-
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§156.10
lations In this Part The contents of a
label must show dearly and promi-
nently the following:
(1) The name, brand, or trademark
tinder which the product is sold as pre-
scribed in paragraph (b) of this sec-
tion;
(11) The name and address of the
producer, registrant, or person for
whom produced as prescribed in para-
graph (c) of this section;
(ill) The net contents as prescribed
in paragraph (d) of this section:
(iv) The product registration
number as prescribed in paragraph (e)
of this section;
(v) The producing establishment
number as prescribed in paragraph (f)
of this section;
Ort) An ingredient statement as pre-
scribed in paragraph (g) of this sec-
tion;
(vil) Warning or precautionary state-
ments as prescribed in paragraph (h)
of this section;
(viii) The directions for use as pre-
scribed in paragraph (1) of this section;
and
AH required label text must:
(A) Be set in 6-polnt or larger type;
(B) Appear on a clear contrasting
background; and
(C) Not be obscured or crowded.
(3) Lanffuaye to be sued. All required
label or labeling text shall appear in
the English language. However, the
Agency may require or the applicant
may propose additional text in other
languages as is considered necessary to
protect the public. When additional
text in another language is necessary,
all labeling requirements will be ap-
plied equally to both the English and
40 CFR Ch. I (7-l-i9
other-langusge versions of the label-
ing.
(4) Placement of Label(1) General
The label shall appear on or be secure.
ly attached i» the Immediate contain.
er of the pctsticide product. For pur-
poses of this Section, and the mi*.
branding provisions of the Act. "se-
curely attached" shall mean that a
label can reasonably be expected to
remain affixed during the foreseeable
conditions and period of use. If the im-
mediate container is enclosed within a
wrapper or outside container through
which the lalbel cannot be clearly read.
the label must also be securely at-
tached to such outside wrapper or con-
tainer, if it is a part of the package as
customarily ttistrtbuted or sold.
(ii) Tan* car* and other bulk con-
tainer*(A) Transportation. While a
pesticide product is in transit, the ap-
propriate provisions of 49 CFR Parts
170*189, concerning the transportation
of hazardous materials, and specifical-
ly those pro'risions concerning the la-
beling, marking and placarding of haz-
ardous mateiials and the vehicles car-
rying them, define the basic Federal
requirementi. In addition, when any
registered pisticide product is trans-
ported In a tank car, tank truck or
other mobile or portable bulk contain-
er, a copy oi the accepted label must
be attached to the shipping papers,
and left with the consignee at the time
of delivery.
(B) Storage. When pesticide prod-
ucts are stared in bulk containers,
whether mobile or stationary, which
remain in the custody of the user, a
copy of the label of labeling, including
all appropriate directions for use, shall
be securely attached to the container
in the Immediate vicinity of the dis-
charge control valve.
(5) Falte or misleading statements.
Pursuant to section 2B Examples of statements
or representations in the labeling
which constitute misbranding include:
(1) A false or **»toltiMllinig statement
concerning the composition of the
product;
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Protection Agency
(ID A false or misleading statement
concerning the effectiveness of the
Product as a pesticide or device;
(ill) A false or misleading statement
-bout the value of the product for
purposes other than as a pesticide or
device;
"Among the least toxic chemi-
cals known"
(C) "Pollution approved"
(6) Final printed labeling. (1) Except
as provided in paragraph (aX6Xil) of
this section, final printed labeling
must be submitted and accepted prior
to registration. However, final printed
labeling need not be submitted until
draft label texts have been provision-
ally accepted by the Agency.
(11) Clearly legible reproductions or
photo reductions will be accepted for
unusual labels such as those silk-
screened directly onto glass or metal
containers or large bag or drum labels.
Such reproductions must be of micro-
film reproduction quality.
§ 156.10
(b) Name, brand, or trademark. (1)
The name, brand, or trademark under
which the pesticide product Is sold
shall appear on the front panel of the
label.
(2) No name, brand, or trademark
may appear on the label which:
(i) Is false or misleading, or
(tl) Has not been approved by the
Administrator through registration or
supplemental registration as an addi-
tional name pursuant to 1152.132.
(c) Name and address of producer,
registrant, or person for whom pro-
duced. An unqualified name and ad-
dress given on the label shall be con-
sidered as the name and address of the
producer. If the registrant's name ap-
pears on the label and the registrant is
not the producer, or if the name of the
person for whom the pesticide was
produced appears on the label, it must
be qualified by appropriate wording
such as "Packed for * V "Distribut-
ed by V or "Sold by to show
that the name is not that of the pro-
ducer.
(d) Net weight or meature of con-
tent*. (1) The net weight or measure
of content shall be exclusive of wrap-
pers or other materials and shall be
the average content unless explicitly
stated as a minimum quantity.
(2) If the pesticide is a liquid, the
net content statement shall be in
terms of liquid measure at 68* F (20*C>
and shall be expressed in conventional
American units of fluid ounces, pints,
quarts, and gallons.
(3) If the pesticide is solid or semi-
solid, viscous or pressurized, or is a
mixture of liquid and solid, the net
content statement shall be in terms of
weight expressed as avoirdupois
pounds and ounces.
(4) In all cases, net content shall be
stated in terms of the largest suitable
units, Le., "1 pound 10 ounces" rather
tban "26 ounces."
(5) In addition to the required units
specified, net content may be ex-
pressed in metric units.
(6) Variation above tnintmum eon-
tent or around an average is permissi-
ble only to the extent that it repre-
sents deviation unavoidable in good
manufacturing practice. Variation
below a stated mifiimnm i* not permit-
ted. In no case shall the average con-
-------
{ 156.10
tent of the packages In a shipment fall
Thi rtflrtrttlon
J£5l not appear to such a mumer u
toinraest or Imply recommendation
or endorsement of the product by the
(f ) Producing establishments regis-
tration number. The producing estab-
lishment registration number preced-
ed by the phrase "EPA Est". of the
final establishment at which the prod-
uct was produced may appear In any
suitable location on the label or Imme-
diate container. It must appear on the
wrapper or outside container of the
package if the EPA establishment reg-
istration number on the Immediate
container cannot be clearly read
through such wrapper or container.
(g) Ingredient statement (1) Gener-
al The label of each pesticide product
must bear a statement which contains
the name and percentage by weight of
each active ingredient, the total per-
centage by weight of all Inert Ingredi-
ents; and if the pesticide contains ar-
senic In any form, a statement of the
percentages of total and water-soluble
arsenic calculated as elemental ar-
senic. The active Ingredients must be
designated by the term "active Ingredi-
ents" and the Inert Ingredients by the
term "Inert Ingredients," or the singu-
lar forms of these terms when appro-
priate. Both terms shall be m the
same type size, be aligned to the same
margin and be equally prominent. The
statement "Inert Ingredients, none" Is
not required for pesticides which con-
tain 100 percent active ingredients.
Unless the tngi^dlftnt statement Is a
complete analysis of the pesticide, the
term "analysis" shall not be used as a
heading for the Ingredient statement
(2) Petition of ingredient statement
(I) The ingredient statement Is nor-
mally required on the front panel of
40 CJf* Ch. I (7-1-89 Edition)
the label. If there Is an outside con-
tataer or wrapper through which the
ingredient statement cannot be clearly
read, the Ingredient statement must
fi«o appear era such outside container
or wrapper. If the size or form of the
package makes It Impracticable to
place the Ingredient statement on the
front panel of the label* permission
may be granted for the Ingredient
statement to uppear elsewhere.
(II) The text of the Ingredient state-
ment must inn parallel with other
text on the piinel on which it appears,
arm must be1 clearly distinguishable
from and must not be placed In the
body of other text.
($) Names ito be used in ingredient
statement The name used for each in-
gredient shiiU be the accepted
common name. If there Is one, fol-
lowed by this chemical name. The
common nanui may be used alone only
If it Is well known. If no common name
has been established, the ctifFftteal
name alone sliall be used. In no case
will the use of a trademark or proprie-
tary name be permitted unless such
name has been accepted as a common
name by the Administrator under the
authority of section 25(cx6).
(4) Statements of percentages. The
percentages of ingredients shall be
stated In terras of weight-to-weight.
The sum of percentages of the active
and the Inert ingredients shall be 100.
Percentages stall not be expressed by
a range of values such as "22-25%." If
the uses of the pesticide product are
expressed as weight of active Ingredi-
ent per unit urea, a statement of the
weight of active ingredient per unit
volume of the pesticide formulation
also apt>ear In the Ingredient
-*- .«.
(5) Accuracy o/ stated percentages.
The percentage* given shall be as pre-
cise as possible reflecting good manu-
facturing practice. If there may be un-
avoidable variation between manufac-
turing batches, the value stated for
each active Ingredient shall be the
lowest percentage which may be
present.
(6) Deterioration. Pesticides which
change in chemical composition sig-
nificantly must meet the following la-
beling requirements:
-------
Protection Agoncy
jn cases where It IB determined
pesticide formulation changes
composition significantly,
ct must bear the following
ctatement in a prominent position on
the label: "Not for sale or use after
CdsteJ."
(11) The product must meet all label
Hifm* up to the expiration time indl-
^ted on the label.
(7) Inert ingredients. The Adminis-
trator may require the name of any
inert ingredients) to be listed in the
ingredient statement if he determines
tfatt such ingredients) may pose a
hazard to man or the environment.
(fa) Warnings and precautionary
statement*. Required warnings and
precautionary statements concerning
§ 156.10
the general areas of toxicologies!
hazard including hazard to children,
environmental hazard, and physical or
chemical hazard fall into two groups;
those required on the front panel of
the labeling and those which may
appear elsewhere. Specific require-
ments concerning content* placement,
type sice, and prominence are given
below.
(1) Required front panel statement*.
With the exception of the child
hazard warning statement, the text re-
quired on the front panel of the label
is determined by the Toxidty Catego-
ry of the pesticide. The category is as-
signed on the basis of the highest
hazard shown by any of the indicators
in the table below:
Hart Morion
1
TntoHycsttgorfM
IV
Up to wtd metudng SO
mo/kp,
Upto«ndMm«ng ^
rmttLOii
Up to and induing 200
FromSOtnil
From a. tnt 2 mg/M»r_
From 200 ttiru 2000 __
From 000 ttmt SOOO mo/
kg.
From 2. «vu 20 ng/Mv-
From 2,000 thm 20,000
mg/
V jd^M
f ovyv*
Conotli
vMnBIO MHPWl 7
kiN§Hun iw*w
Skin nteti..
Coma**.
SCVOT Mtefen it 72
Hem.
hnn.
MtttfOA d 72
QrwMrfMntompyiHw.
QrMMrtwi 204)00.
ND viiiRiiuix
MU or MgM WWton «
72 hours.
(i) Human hazard signal word(A)
Toxicity Category L All pesticide prod-
ucts meeting the criteria of Toxicity
Category X shall bear on the front
panel the signal word "Danger." In ad-
dition if the product was assigned to
Toxicity Category I on the basis of its
oral, inhalation or dermal toxlclty (as
distinct from akin and eye local ef-
fects) the word "Poison" shall appear
in red on a background of distinctly
contrasting color and the skull and
crossbones shall appear in immediate
proximity to the word "poison."
(B) Toxicitv Category II. All pesti-
dde products meeting the criteria of
Toxicity Category II shall bear on the
front panel the signal word "Warn-
ing."
(C) Toxicitv Category III. All pesti-
cide products meeting the criteria of
Toxicity Category m shall bear on
the front panel the signal word "Cau-
tion."
(D) Toxicitv Category IV. All pesti-
cide products meeting the criteria of
Toxicity Category IV shall bear on the
front panel the signal word "Caution."
(E) U»e of signal words. Use of any
signal word(s) associated with a higher
Toxicity Category is not permitted
except when the Agency determines
that such labeling is necessary to pre-
vent unreasonable adverse effects on
man or the environment. In no case
shall more than one human hazard
signal word appear on the front panel
of a label.
(11) Child haeard warning. Every pes-
ticide product label shall bear on the
front panel the statement "keep out of
reach of children." Only in cases
where the likelihood of contact with
children during distribution, market-
ing, storage or use is demonstrated by
the applicant to be extremely remote,
or if the nature of the pesticide is such
-------
§U6.1§
that it is approved for use on Infanta
or amall children, may the Administra-
tor waive this requirement.
(Ill) Statement of practice! treat-
mate(A) Toxicity Category /.A
statement of practical treatment (first
aid or other) shall appear on the front
panel of the label of all pesticides fall-
ing into Toxldty Category I on the
frarit of oral, inhalation or dermal tox-
teity. The Agency may,, however,
permit reasonable variations In the
placement of the statement of practi-
cal treatment Is some reference such
as "See statement of practical treat-
ment on back panel" appears on the
front panel near the word "Poison"
and the skull and crossbones.
(B) Other toxidtv categories. The
statement of practical treatment is not
required on the front panel except as
described In paragraph (hXIXiiiXA) of
tills section. The applicant may. how-
ever, include such a front panel state-
ment at his option. Statements of
practical treatment are, however, re-
quired elsewhere on the label in
accord with paragraph (hX2> of this
section if they do not appear on the
front paneL
(lv> Placement and prominence. All
the require front panel warning state-
ments shall be grouped together on
the label, and shall appear with suffi-
cient prominence relative to other
front panel text and graphic material
to make them unlikely to be over-
looked under customary conditions of
purchase and use. The following table
shows the minimm^ type size require-
40 em Ch. I (7.1-89
menu for the front panel warniQ.
statements on various sizes of labels:
of Ivbol wort pofw in
Bond i
10
«
14
It
I
I
10
(2) Other required warning* and pr*.
cautionary statements. The warnings
and precautionary statements as re-
quired below atiall appear together on
the label under the general heading
"Precautionary Statements" and
under appreciate subheadings of
"Hazard to Humans and Domestic Ani-
mals,*' "Environmental Hazard" npui
"Physical or Chemical Hazard."
(i) Hazard to human* and domettic
animate. (A) Wbere a hazard exists to
humans or domestic animals, precau-
tionary statements are required Indi-
cating the particular hazard, the
routeis) of exposure and the precau-
tions to be taken to avoid accident,
injury or damage. The precautionary
paragraph shall be Immediately pre-
ceded by the appropriate hazard signal
word.
(B) The folloiring table depicts typi-
cal precautionary statements. These
statements mtut be modified or ex-
panded to reflect specific hazards.
To**
Mn«nd«y*lMoJ
t OMvloviNid [inhilod or ibtofbod
VvouQh sttnj. Do not bfoofho vopor Cdutt or vpfoy
(FfOflt
(v
Oo not 901 to tiyvt, on thta, or on
^tm ^^L^^ ^^1^.1^ -*
Or svDO OTMIO ffjnO
^OHAd «^
nvmnii or
If M*MSbM*Mril rMBBMia** A*
VlWowVwlJ IWW^PM fjr
thfouQh tfw cWnj. Oo not braMths) mpovs (duM of
pray nUtU. Pe not got m »>. on
i ay* [and trtdnl Mutton. Do not got to ayat.
^_- Ai^K ^» ^tfh ^UMlft^Mk U*«^^d It ^H^hSbM^^tft ft*A*k_
sjn ZWH sji ijn Bjajimsjj nswfnsui « zfSfvsHoojpojii. B>*T|^
tmautad.}
Oat
or Mn «*h ptanry ot
[NO pfs)00MOtsVy
tNoi
-------
Protection Agency
in snvir^nmental hazard*. Where a
* exists to non target organisms
humans and domestic ani-
i. recautionary statements are re-
» stating the nature of the
and the appropriate precau-
to avoid potential accident,
or damage. Examples of the
statements and the drcum-
under which they are required
f a pesticide intended for out-
use contains an active ingredient
g. mft«itMHMi acute oral LDw of
too or less, the statement "This Pesti-
dde is Toxic to Wildlife" is required.
**«»*»*i«, the statement
"This pesticide is extremely toxic to
wildlife (fish)" is required.
(E) For uses involving foliar applica-
tion to agricultural crops, forests, or
shade trees, or for mosquito abate-
ment treatments, pesticides toxic to
pollinating insects must bear appropri-
ate label cautions.
^Ideguocy and clar-
ity of direction*. Directions for use
must be stated in terms which can be
easily read and understood by the av-
erage person likely to use or to super-
vise the use of the pesticide. When fol-
lowed, directions must be adequate to
protect the public from fraud and
from personal injury and to prevent
unreasonable adverse effects on the
environment.
(ii) Placement of directions for me.
Directions may appear on any portion
of the label provided that they are
conspicuous enough to be easily read
by the user of the pesticide product.
Directions for use may appear on
printed or graphic matter which ac-
companies the pesticide provided that:
(A) If required by the Agency, such
printed or graphic matter is securely
attached to each package of the pesti-
cide, or placed within the outside
wrapper or bag:
-------
§156.10
(B) The label bears a reference to
the directions for use in accompanying
leaflets or circulars, such as "See di-
rections in the enclosed circular:'' and
(C) The Administrator determines
that it is not necessary for such direc-
tions to appear on the label.
(Hi) Exception* to requirement for
direction for tite The label clearly states that the
product is for use only by physicians
or veterinarians;
(2) The Administrator determines
that such directions are not necessary
to prevent unreasonable advene ef-
fects on man or the environment; and
The product is also a drug and
regulated under the provisions of the
Federal Food, Drug and Cosmetic Act.
(C) Detailed directions for use may
be omitted from the labeling of pesti-
cide products which are intended for
use only by f ormulaton in preparing
pesticides for sale to the public, pro-
vided that:
(1) There is information readily
available to the formulatar* on the
composition, toxidty, methods of use,
applicable restrictions or limitations,
40 Cm Ch. I (7-1-69 Edition)
and effectivenais of the product for
pesticide purposes;
(*> The label clearly states that the
product Is intended for use only in
manufacturing, formulating,
or repacking for use as a pesticide and
specifies the tyi»e(s) of pesticide prod-
ucts Involved;
(J) The product as finally manufac-
tured, formulated, mixed, or repack-
aged is registerel; and
(.4) The Adixiinistrator determines
that such directions are not necessary
to prevent unreasonable advene ef-
fects on man or the environment.
(2) Content* (if Direction* for Ute.
The directions for use shall include
the following, under the headings "Di-
rections for Use":
(i) The statement of use classifica-
tion as prescribed in paragraph (J) of
this section immediately under the
heading "Directions for Use."
(U) immediately below the state-
ment of use cliisslfication, the state-
ment "It is a violation of Federal law
to use this product in a manner incon-
sistent with its libeling."
(Ill) The site(s> of application, as for
example the crops. Miimaia, areas, or
objects to be treated.
(iv) The tariiet pestts) associated
with each site.
(v) The dosage rate associated with
each site and pent.
(vi) The metbiod of application, in-
cluding instructions for dilution, if re-
quired, and typiKs) of application ap-
paratus or equipment required.
(vii) The frequency and timing of ap-
plications necessary to obtain effective
results without causing unreasonable
adverse effects on the environment.
-------
Protection Agoncy
. | AHJ limitations or restrictions on
... required to prevent unreasonable
SeSe effects, such as:
(A) Required Intervals between ap-
plication and harvest of food or feed
fifOPS.
[Reserved]
(E> For restricted use pesticides, a
jtatement that the pesticide may be
applied under the direct supervision of
.certified applicator who is not phys-
ically present at the site of application
but nonetheless available to the
person applying the pesticide, unless
the Agency has determined that the
pesticide may only be applied under
the direct supervision of a certified ap-
plicator who is physically present
(F) Other pertinent information
which the Administrator determines
to be necessary for the protection of
man and the environment.
(j) Statement of Use Classification,
By October 22. 1976, all pesticide prod-
ucts must bear on their labels a state-
ment of use classification as described
in paragraphs (J) (1) and (2) of this
section. Any pesticide product for
which some uses are classified for gen*
era! use and others for restricted use
shall be separately labeled according
to the labeling standards set forth in
this subsection, and shall be marketed
as separate products with different
registration numbers, one bearing di-
rections only for general use(s) and
the other bearing directions for re-
stricted use(s) except that, if a product
has both restricted use(s) and general
useCs), both of these uses may appear
on a product labeled for restricted use.
Such products shall be subject to the
provisions of paragraph (JX2) of this
section.
(1) General Use Classification. Pesti-
cide products bearing directions for
use(s> classified general shall be la-
beled with the exact words "General
Classification" Immediately below the
heading "Directions for Use." And ref-
erence to the general classification
that suggests or implies that the gen-
eral utility of the pesticide extends
beyond those purposes and uses con-
tained in the Directions for Use wd be
§ 156.10
considered a false or misleading state-
ment under the statutory definitions
of mlsbranding.
(2) Restricted Use Classification,
Pesticide products bearing direction
for use(s) classified restricted shall
bear statements of restricted use clas-
sification on the front panel as de-
scribed below.
(1) Front panel statement of restrict-
ed use classification. (A) At the top of
the front panel of the label, set in type
of the same «itnfa«iit« sizes as required
for human hazard signal words (see
table in paragraph (hXIXiv) of this
section), and appearing with sufficient
prominence relative to other text and
graphic material on the front panel to
make it unlikely to be overlooked
under customary conditions of pur-
chase and use. the statement "Re-
stricted Use Pesticide" shall appear.
-------
-------
APPENDIX F
Generic Data Call-in
39
-------
No generic data are being called-in for:
Oxybisphenoxarsine (OBPA)
40
-------
APPENDIXG
Product Specific Data CaD-In
41
-------
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
DATA CALL-IN NOTICE
OFFICE OF
PREVENTION. PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment A of this Notice, the Data Call-In Chemical Status Sheet.
to submit certain product specific data as noted herein to the U.S. Environmental Protection
Agency (EPA, the Agency). These data are necessary to maintain the continued registration
of your product(s) containing this active ingredient. Within 90 days after you receive this
Notice you must respond as set forth in Section III below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its
Attachments A through G; or
2. Why you believe you are exempt from the requirements listed in this Notice
and in Attachment C, Requirements Status and Registrant's Response Form.
(see section III-B); or
3. Why you believe EPA should not require your submission of product specific
data in the manner specified by this Notice (see section IH-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will
comply with its requirements or should be exempt or excused from doing so, then the
registration of your product(s) subject to this Notice will be subject to suspension. We have
provided a list of all of your products subject to this Notice in Attachment B, Data Call-In
Response Form, as well as a list of all registrants who were sent this Notice (Attachment F).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide,
Fungicide and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B).
Collection of this information is authorized under the Paperwork Reduction Act by OMB
Approval No. 2070-0107 (expiration date 3-31-96).
-------
This Notice is divided into six sections and seven Attachments. The Notice itself
contains information and instructions applicable to all Data Call-In Notices. The
Attachments contain specific chemical information and instructions. The six sections of the
Notice are:
Section I - Why You Are Receiving This Notice
Section II - Data Required By This Notice
Section III - Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With Thh; Notice
Section V - Registrants' Obligation To Report Possible Unrsasonable
Adverse Effects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
A - Data Call-In Chemical Status Sheet
B - Product-Specific Data Call-In Response Form
C - Requirements Status and Registrant's Response Form
D - EPA Grouping of End-Use Products for Meeting Acute Toxicology Data
Requirements for Rerepistration
E - EPA Acceptance Criteria
F - List of Registrants Receiving This Notice
G - Cost Share and Data Compensation Forms, and Product
Specific Data Report Form
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient and reevaluated the
data needed to support continued registration of the subject active ingredient. The Agency
has concluded that the only additional data necessary are product specific data. No additional
generic data requirements are being imposed. You have been sent this Notice because you
have produces) containing the subject active ingredient.
SECTION II. DATA REQUIRED BY THIS NOTICE
H-A. DATA REQUIRED
The product specific data required by this Notice are specified in Attachment C,
Requirements Status and Registrant's Response Form. Depending on the results of the studies
required in this Notice, additional testing may be required.
H-B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements specified in
-------
Attachment C, Requirements Status and Registrant's Response Form, within the timeframes
provided.
n-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been
established.
These EPA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD-recommended test standards conform to those
specified in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the
OECD protocols, they should be modified as appropriate so that the data generated by the study
will satisfy the requirements of 40 CFR § 158. Normally, the Agency will not extend deadlines
for complying with data requirements when the studies were not conducted in accordance with
acceptable standards. The OECD protocols are available from OECD, 1750 Pennsylvania
Avenue N.W., Washington, D.C. 20006.
All new studies and proposed protocols submitted in response to this Data Call-In Notice
must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3rc)(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-Ms1), or any other agreements entered into with the
Agency pertaining to such prior Notice. Registrants must comply with the requirements of all
Notices to avoid issuance of a Notice of Intent to Suspend their affected products.
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
ffl-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for product specific data
must be submitted to the Agency within 90 days after your receipt of this Notice. Failure to
adequately respond to this Notice within 90 days of your receipt will be a basis for issuing a
Notice of Intent to Suspend (NOIS) affecting your products. This and other bases for issuance
of NOIS due to failure to comply with this Notice are presented in Section IV-A and IV-B.
-------
III-B. OPTIONS FOR RESPONDING TO THE AGENCY
The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this notice
or (c) request a data waiver(s).
A discussion of how to respond if you chose the Voluntary Cancellation option is
presented below. A discussion of the various options available for satisfying the product
specific data requirements of this Notice is contained in Section III-C. A discussion of options
relating to requests for data waivers is contained in Section III-D.
There are two forms that accompany this Notice of which, depending upon your
response, one or both must be used in your response to the Agency. These forms are the Data-
Call-in Response Form, and the Requirements Status and Registrant's Response Form.
Attachment B and Attachment C. The Data Call-In Response Form must be submitted as part of
every response to this Notice. In addition, one copy of the Requirements Status and
Registrant's Response Form must be submitted for each product listed on the Data Call-In
Response Form unless the voluntary cancellation option is selected or unless the product is
identical to another (refer to the instructions for completing the Data Call-In Response Form in
Attachment B). Please note that the company's authorized representative is required to sign the
first page of the Data Call-In Response Form and Requirements Status and Registrant's
Response Form (if this form is required) and initial any subsequent pages. The forms contain
separate detailed instructions on the response options. Do not alter the printed material. If you
have questions or need assistance in preparing your response, call or write the contact person(s)
identified in Attachment A.
1. Voluntary Cancellation - You may avoid the requirements of this Notice by requesting
voluntary cancellation of your product(s) containing the active ingredient that is the subject of
this Notice. If you wish to voluntarily cancel your product, you must submit a completed Data
Call-in Response Form, indicating your election of this option. Voluntary cancellation is item
number 5 on the Data Call-In Response Form. If you choose this option, this is the only form
that you are required to complete.
If you chose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C.
2. Satisfying the Product Specific Data Requirements of this Notice There are various
options available to satisfy the product specific data requirements of <:his Notice. These options
are discussed in Section III-C of this Notice and comprise options 1 through 6 on the
Requirements Status and Registrant's Response Form and item numbers 7a and 7b on the Data
Call-In Response Form. Deletion of a use(s) and the low volume/minor use option are not valid
options for fulfilling product specific data requirements.
-------
3. Request for Product Specific Data Waivers. Waivers for product specific data are
discussed in Section III-D of this Notice and are covered by option 7 on the Requirements
Status and Registrant's Response Form. If you choose one of these options, you must submit
both forms as well as any other information/data pertaining to the option chosen to address the
data requirement.
ni-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-In Response Form that you agree to satisfy the
product specific data requirements (i.e. you select item number 7a or 7b), then you must select
one of the six options on the Requirements Status and Registrant's Response Form related to
data production for each data requirement. Your option selection should be entered under item
number 9, "Registrant Response." The six options related to data production are the first six
options discussed under item 9 in the instructions for completing the Requirements Status and
Registrant's Response Form. These six options are listed immediately below with information
in parentheses to guide registrants to additional instructions provided in this Section. The
options are:
(1) I will generate and submit data within the specified timeframe (Developing Data)
(2) I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an existing
study that has been submitted but not reviewed by the Agency (Citing an Existing
Study)
Option 1. Developing Data ~ If you choose to develop the required data it must be in
conformance with Agency deadlines and with other Agency requirements as referenced herein
and in the attachments. All data generated and submitted must comply with the Good
Laboratory Practice (GLP) rule (40 CFR Part 160), be conducted according to the Pesticide
Assessment Guidelines (PAG), and be in conformance with the requirements of PR Notice 86-5.
The time frames in the Requirements Status and Registrant's Response Form are the time
frames that the Agency is allowing for the submission of completed study reports. The noted
deadlines run from the date of the receipt of this Notice by the registrant. If the data are not
submitted by the deadline, each registrant is subject to receipt of a Notice of Intent to Suspend
the affected registration(s).
If you cannot submit the data/reports to the Agency in the time required by this Notice
and intend to seek additional time to meet the requirements(s), you must submit a request to the
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Agency which includes: (1) a detailed description of the expected difficulty and (2) a proposed
schedule including alternative dates for meeting such requirements on a step-by-step basis. You
must explain any technical or laboratory difficulties and provide documentation from the
laboratory performing the testing. While EPA is considering your request, the original deadline
remains. The Agency will respond to your request in writing. If EPA does not grant your
request, the original deadline remains. Normally, extensions can be requested only in cases of
extraordinary testing problems beyond the expectation or control of the registrant. Extensions
will not be given in submitting the 90-day responses. Extensions will not be considered if the
request for extension is not made in a timely fashion; in no event shidl an extension request be
considered if it is submitted at or after the lapse of the subject deadline.
Option 2T Agreement to Share in Cost to Develop Data - Registrants may on|y 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 sire similar for purposes of
depending on the same data. If this is the case, data may be generated for just one of the
products in the group. The registration number of the product for which data will be submitted
must be noted in the agreement to cost share by the registrant selecting this option. If you
choose to enter into an agreement to share in the cost of producing the required data but will
not be submitting the data yourself, you must provide the name of the registrant who will be
submitting the data. You must also provide EPA with documentary evidence that an agreement
has been formed. Such evidence may be your letter offering to join in an agreement and the
other registrant's acceptance of your offer, or a written statement by the parties that an
agreement exists. The agreement to produce the data need not specify all of the terms of the
final arrangement between the parties or the mechanism to resolve the terms. Section 3(c)(2)(B)
provides that if the parties cannot resolve the terms of the agreement they may resolve their
differences through binding arbitration.
Option 3. Offer to Share in the Cost of Data Development This option only applies to
acute toxicity and certain efficacy data as described in option 2 above. If you have made an
offer to pay in an attempt to enter into an agreement or amend an existing agreement to meet
the requirements of this Notice and have been unsuccessful, you may request EPA (by selecting
this option) to exercise its discretion not to suspend your registration! s), although you do not
comply with the data submission requirements of this Notice. EPA has determined that as a
general policy, absent other relevant considerations, it will not suspend the registration of a
product of a registrant who has in good faith sought and continues to seek to enter into a joint
data development/cost sharing program, but the other registrant(s) developing the data has
refused to accept your offer. To qualify for this option, you must submit documentation to the
Agency proving that you have made an offer to another registrant (who has an obligation to
submit data) to share in the burden of developing that data. You must also submit to the
Agency a completed EPA Form 8570-32, Certification of Offer to Cost Share in the
Development of Data, Attachment G. In addition, you must demons xate that the other
registrant to whom the offer was made has not accepted your offer to enter into a costsharing
agreement by including a copy of your offer and proof of the other registrant's receipt of that
offer (such as a certified mail receipt). Your offer must, in addition to anything else, offer to
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share in the burden of producing the data upon terms to be agreed or failing agreement to be
bound by binding arbitration as provided by FIFRA section 3(c)(2)(B)(iii) and must not qualify
this offer. The other registrant must also inform EPA of its election of an option to develop
and submit the data required by this Notice by submitting a Data Call-In Response Form and a
Requirements Status and Registrant's Response Form committing to develop and submit the data
required by this Notice.
In order for you to avoid suspension under this option, you may not withdraw your offer
to share in the burdens of developing the data. In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this Notice. If the other registrant
fails to develop the data or for some other reason is subject to suspension, your registration as
well as that of the other registrant will normally be subject to initiation of suspension
proceedings, unless you commit to submit, and do submit the required data in the specified time
frame. In such cases, the Agency generally will not grant a time extension for submitting the
data,
Option 4. Submitting an Existing Study - If you choose to submit an existing study in
response to this Notice, you must determine that the study satisfies the requirements imposed by
this Notice. You may only submit a study that has not been previously submitted to the Agency
or previously cited by anyone. Existing studies are studies which predate issuance of this
Notice. Do not use this option if you are submitting data to upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the
required date of submission. The Agency may determine at any time that a study is not valid
and needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly met:
a. You must certify at the time that the existing study is submitted that the raw data and
specimens from the study are available for audit and review and you must identify where
they are available. This must be done in accordance with the requirements of the Good
Laboratory Practice (GLP) regulation, 40 CFR Part 160. As stated in 40 CFR 160.3(j)
" '[r]aw data* means any laboratory worksheets, records, memoranda, notes, or exact
copies thereof, that are the result of original observations and activities of a study and
are necessary for the reconstruction and evaluation of the report of that study. In the
event that exact transcripts of raw data have been prepared (e.g., tapes which have been
transcribed verbatim, dated, and verified accurate by signature), the exact copy or exact
transcript may be substituted for the original source as raw data. 'Raw data' may
include photographs, microfilm or microfiche copies, computer printouts, magnetic
media, including dictated observations, and recorded data from automated instruments."
The term "specimens", according to 40 CFR 160.3(k), means "any material derived
from a test system for examination or analysis."
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8
b. Health and safety studies completed after May 1984 must iilso contain all GLP-
required quality assurance and quality control information, pursuant to the requirements
of 40 CFR Part 160. Registrants must also certify at the time of submitting die 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 Registration Phase 3
Technical Guidance and that the study has been conducted according to the Pesticide
Assessment Guidelines (PAG) or meets the purpose of the PAG (both available from
NTIS). A study not conducted according to the PAG may be submitted to the Agency
for consideration if the registrant believes that the study clearly meets the purpose of the
PAG. The registrant is referred to 40 CFR 158.70 which states the Agency's policy
regarding acceptable protocols. If you wish to submit the study, you must, in addition to
certifying that the purposes of the PAG are met by the study, clearly articulate the
rationale why you believe the study meets the purpose of the PAG, including copies of
any supporting information or data. It has been the Agency's experience that studies
completed prior to January 1970 rarely satisfied the purpose of the PAG and that
necessary raw data are usually not available for such studies.
If you submit an existing study, you must certify that the study meets all requirements of
the criteria outlined above.
If you know of a study pertaining to any requirement in this Notice which does not meet
the criteria outlined above but does contain factual information regarding unreasonable adverse
effects, you must notify the Agency of such a study. If such study : s in the Agency's files,
you need only cite it along with the notification. If not in the Agency's files, you must submit a
summary and copies as required by PR Notice 86-5.
Option 5. Upgrading a Study If a study has been classified as partially acceptable and
upgradeable, you may submit data to upgrade that study. The Agency will review the data
submitted and determine if the requirement is satisfied. If the Agency decides the requirement
is not satisfied, you may still be required to submit new data normally without any time
extension. Deficient, but upgradeable studies will normally be classified as supplemental.
However, it is important to note that not all studies classified as supplemental are upgradeable.
If you have questions regarding the classification of a study or whether a study may be
upgraded, call or write the contact person listed in Attachment A. If you submit data to
upgrade an existing study you must satisfy or supply information to correct all deficiencies in
the study identified by EPA. You must provide a clearly articulated rationale of how the
deficiencies have been remedied or corrected and why the study should be rated as acceptable to
EPA. Your submission must also specify the MRID number(s) of the study which you are
attempting to upgrade and must be in conformance with PR Notice 86-5.
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Do not submit additional data for the purpose of upgrading a study classified as
unacceptable and determined by the Agency as not capable of being upgraded.
This option should also be used to cite data that has been previously submitted to
upgrade a study, but has not yet been reviewed by the Agency. You must provide the MRID
number of the data submission as well as the MRID number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4 above, apply to all
data submissions intended to upgrade studies. Additionally your submission of data intended to
upgrade studies must be accompanied by a certification that you comply with each of those
criteria as well as a certification regarding protocol compliance with Agency requirements.
Option 6f Citing Existing Studies - If you choose to cite a study that has been
previously submitted to EPA, that study must have been previously classified by EPA as
acceptable or it must be a study which has not yet been reviewed by the Agency. Acceptable
toxicology studies generally will have been classified as "core-guideline" or "core minimum."
For all other disciplines the classification would be "acceptable." With respect to any studies
for which you wish to select this option you must provide the MRID number of the study you
are citing and, if the study has been reviewed by the Agency, you must provide the Agency's
classification of the study.
If you are citing a study of which you are not the original data submitter, you must
submit a completed copy of EPA Form 8570-31, Certification with Respect to Data
Compensation Requirements.
Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-In Response Form and the
Requirements Status and Registrant's Response Form, as appropriate.
III-D REQUESTS FOR DATA WAIVERS
If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete justification for the request, including technical
reasons, data and references to relevant EPA regulations, guidelines or policies. (Note: any
supplemental data must be submitted in the format required by PR Notice 86-5). This will be
the only opportunity to state the reasons or provide information in support of your request. If
the Agency approves your waiver request, you will not be required to supply the data pursuant
to section 3(c)(2)(B) of FIFRA. If the Agency denies your waiver request, you must choose an
option for meeting the data requirements of this Notice within 30 days of the receipt of the
Agency's decision. You must indicate and submit the option chosen on the Requirements Status
and Registrant's Response Form. Product specific data requirements for product chemistry,
acute toxicity and efficacy (where appropriate) are required for all products and the Agency
would grant a waiver only under extraordinary circumstances. You should also be aware that
submitting a waiver request will not automatically extend the due date for the study in question.
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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 to Suspend product* subject to this Notice due
to failure by a registrant to comply with the requirements of this Dala Call-In Notice, pursuant
to FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a Notice of Intent
to Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of this Notice.
2. Failure to submit on the required schedule an acceptable proposed or final protocol when
such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on a study as
required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this Notice.
5. Failure to take a required action or submit adequate information pertaining to any option
chosen to address the data requirements (e.g., any required action or information pertaining
to submission or citation of existing studies or offers, arrangemerts, or arbitration on the
sharing of costs or the formation of Task Forces, failure to comply with the terms of an
agreement or arbitration concerning joint data development or failure to comply with any
terms of a data waiver).
6. Failure to submit supportable certifications as to the conditions o * submitted studies, as
required by Section III-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost of
developing data and provided proof of the registrant's receipt of such offer or failure of a
registrant on whom you rely for a generic data exemption either to:
a. inform EPA of intent to develop and submit the data required by this Notice on a
Data Call-In Response Form and a Requirements Status and Registrant's Response Form:
b. fulfil] the commitment to develop and submit the data as required by this Notice; or
c. otherwise take appropriate steps to meet the requirements stated in this Notice, unless
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11
you commit to submit and do submit the required data in the specified time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at any time
following the issuance of this Notice.
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds
for suspension include, but are not limited to, failure to meet any of the following:
1. EPA requirements specified in the Data Call-In Notice or other documents
incorporated by reference (including, as applicable, EPA Pesticide Assessment
Guidelines, Data Reporting Guidelines, and GeneTox Health Effects Test Guidelines)
regarding the design, conduct, and reporting of required studies. Such requirements
include, but are not limited to, those relating to test material, test procedures, selection
of species, number of animals, sex and distribution of animals, dose and effect levels to
be tested or attained, duration of test, and, as applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the incorporation
of any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner of reporting,
the completeness of results, and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or included in this Notice or
contained in PR 86-5. All studies must be submitted in the form of a final report; a
preliminary report will not be considered to fulfill the submission requirement.
IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing
stocks of a pesticide product which has been suspended or cancelled if doing so would be
consistent with the purposes of the Act.
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding would generally not
be consistent with the Act's purposes. Accordingly, the Agency anticipates granting registrants
permission to sell, distribute, or use existing stocks of suspended product(s) only in exceptional
circumstances. If you believe such disposition of existing stocks of your product(s) which may
be suspended for failure to comply with this Notice should be permitted, you have the burden of
clearly demonstrating to EPA that granting such permission would be consistent with the Act.
You must also explain why an "existing stocks" provision is necessary, including a statement of
the quantity of existing stocks and your estimate of the time required for their sale, distribution,
and use. Unless you meet this burden the Agency will not consider any request pertaining to
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12
the continued sale, distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this Notice
and your product is in full compliance with all Agency requirements, you will have, under most
circumstances, one year from the date your 90 day response to this Notice is due, to sell,
distribute, or use existing stocks. Normally, the Agency will allow persons other than the
registrant such as independent distributors, retailers and end users to sell, distribute or use such
existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of
voluntarily cancelled products containing an active ingredient for which the Agency has
particular risk concerns will be determined on case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required by
this Notice will not result in the Agency granting any additional time to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was due unless you
demonstrate to the Agency that you are in full compliance with all Agency requirements,
including the requirements of this Notice. For example, if you decide to voluntarily cancel
your registration six months before a 3 year study is scheduled to be submitted, all progress
reports and other information necessary to establish that you have besn 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 ths.t 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 sh;dl submit the information
to the Agency. Registrants must notify the Agency of any factual information they have, from
whatever source, including but not limited to interim or preliminary results of studies, regarding
unreasonable adverse effects on man or the environment. This requirement continues as long as
the products are registered by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person(s) listed in Attachment A, the Data Call-in Chemical Status
Sheet.
All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-In Response Form and a completed
Requirements Status and Registrant's Response Form (Attachment B for generic data and
Attachment C for product specific data) and any other documents required by this Notice, and
should be submitted to the contact person(s) identified in Attachment A. If the voluntary
cancellation or generic data exemption option is chosen, only the Data Call-In Response Form
need be submitted.
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The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in response to this
Notice.
Sincerely yours,
£&i, UBM<4»*<~/
Daniel M. Barolo, Director
Special Review and
Reregistration Division
Attachments
A - Data Call-In Chemical Status Sheet
B - Product-Specific Data Call-In Response Form
C - Requirements Status and Registrant's Response Form
for the Product Specific Data Call-in
D - EPA Grouping of End-Use Products for Meeting Acute
Toxicology Data Requirements for Reregistration
E - EPA Acceptance Criteria
F - List of Registrants Receiving This Notice
G - Cost Share and Data Compensation Forms, and Product
Specific Data Report Form
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ATTACHMENT A
Product Specific DCI Chemical Status Sheet
42
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ATTACHMENT A
OBPA
PRODUCT SPECIFIC DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have products
containing OBPA.
This Product Specific Pafr 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
OBPA products. This attachment is to be used in conjunction with (1) the Product Specific Data
Call-In Notice, (2) the Product Specific Data Call-in Response Form (Attachment B), (3) the
Requirements Status and Registrant's Form (Attachment C), (4) EPA's Grouping of End-Use
Products for Meeting Acute Toxicology Data Requirements for Reregistration (Attachment D),
(5) EPA Acceptance Criteria (Attachment E), (6) List of Registrants Receiving this Notice
(Attachment F), and (7) the Cost Share and Data Compensation Forms (Attachment G) in
replying to this OBPA Product Specific Data Call-In. Instructions and guidance accompany each
form.
DATA REQVfflgp BY THIS NOTICE
The additional data requirements needed to complete the product specific database for OBPA
are contained in the Requirements Status and Registrant's Response (Attachment C). The
Agency has concluded that additional data on OBPA are needed for specific products. While
product specific data requirements were imposed in the 1981 Registration Standard, a complete
listing is provided in Attachment C. If you, as a registrant of an OBPA product, responded to
the 1981 Registration Standard and submitted the data relating to your specific product, simply
choose response number 6 and cite the MRID number that was assigned to your study.
Otherwise, these data are required to be submitted to the Agency within the time-frame listed.
These data are needed to complete the reregistration of all eligible OBPA products.
RESPONSES TO THIS NOTICE
Any questions in regards to this RED, should be directed to Venus Eagle, Chemical Review
Manager, Reregistration Branch, Special Review and Reregistration Division, at (703) 308 -
8045.
43
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If you have any questions regarding the product specific data requirements and procedures
established by this Notice, please contact Cynthia Giles-Parker (703) 305 - 5540.
All responses to this Notice for the product specific data requirements should be submitted
to:
Cynthia Giles-Parker, Product Manager 22
Fungicide-Herbicide Branch
Registration Division (H7505C)
Office of Pesticide Programs
U.S. Environmental Protection Agency
401 M Street, S.W.
Washington, D.C. 20460
RE: OBPA
44
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ATTACHMENT B
Product Specific Data Call-in Response Forms (Form A)
plus Instructions
45
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INSTRUCTIONS FOR COMPLETING THE "DATA CALL-IN RESPONSE" FORM FOR
PRODUCT SPECIFIC DATA
Item 1-4. Already completed by EPA.
Item 5. If you wish to voluntarily cancel your product, answer "yes*. If you choose this
option, you will not have to provide the data required by the Data Call-In Notice
and you will not have to complete any other forms. Further sale and distribution
of your product after the effective date of cancellation must be in accordance with
the Existing Stocks provision of the Data Call-In Notice (Section IV-C).
Item 6. Not applicable since this form calls in product specific data only. However, if
your product is identical to another product and you qualify for a data exemption,
you must respond with "yes" to Item 7a (MUP) or 7B (EUP) on this form,
provide the EPA reregistration numbers of your source (s); you would not
complete the requirements status and registrant's response* form. Examples of
such products include repackaged products and Special Local Needs (Section 24c)
products which are identical to federally registered products.
Item 7a. For each manufacturing use product (MUP) for which you wish to maintain
registration, you must agree to satisfy the data requirements by responding "yes."
Item 7b. For each end use product (EUP) for which you wish to maintain registration, you
must agree to satisfy the data requirements by responding "yes." if you are
requesting a data waiver, answer "yes" here; in addition, on the "Requirements
Status and Registrant's Response" form under Item 9, you must respond with
option 7 (Waiver Request) for each study for which you are requesting a waiver.
See item 6 with regard to identical products and data exemptions.
Items 8-11.Self-explanatory.
Note: You may provide additional information that does not fit on this form in a signed letter
that accompanies this form. For example, you may wish to report that your product has
already been transferred to another or that you have already voluntarily cancelled this
product. For these cases, please supply all relevant details so that EPA can ensure that
its records are correct.
46
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ATTACHMENT C
Product Specific Data Call-in Requirements Status and
Registrant's Response Forms (Form B) plus Instructions
47
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS
REGISTRANT'S RESPONSE" FORM FOR PRODUCT SPECIFIC DATA
AND
Item 1-3 Completed by EPA. Note the unique identifier number assigned by EPA in item
3. This number must be used in the transmittal document for any data
submissions in response to this Data Call-In Notice.
Item 4. The guidelines reference numbers of studies required to support the product's
continued registration are identified. These guidelines, in addition to the
requirements specified! in the Notice, govern the conduct of the required studies.
Note that series 61 and 62 in product chemistry are now listed under 40 CFR
158.155 through 158.180, Subpait c.
Item 5. The study tide associated with the guideline reference number is identified.
Item 6. The use patters (s) of the pesticide associated with the product specific
requirements is (are) identified. For most product specific data requirements, all
use patterns are covered by the data requirements. In the case of efficacy data,
the required studies only pertain to products which have the use sites and/ or
pests indicatpda
Item 7. The substance to be tested is identified by EPA. For product specific data, the
product as formulated for sale and distribution is the test substance, except in rare
cases.
Item 8. The due date for submission of each study is identified. It is normally based on
8 months after issuance of the Registration Eligibility Documents unless EPA
determines that a longer time period is necessary.
Item 9. Enter Only one of the following response codes for each data requirement to
show how you intend to comply with the data requirements listed in this table.
Fuller descriptions of each option are contained in the Data Call-In Notice.
1. I will generate and submit data by the specified due date (Developing Data). By indicating
that I have chosen this option, I certify that I will comply with all the requirements
pertaining to the conditions for submittal of this study as outlined in the Data Call-In Notice.
2. I have entered into an agreement with one or more registrants to develop data jointly (Cost
Sharing). I am submitting a copy of this agreement. I understand that this option is
available on for acute toxicily or certain efficacy data and only if EPA indicates in an
attachment to this notice that my product is similar. Enough to another product to qualify
for this option. I certify that another party in the agreement is committing to submit or
provide the required data; if the required study is not submitted on time, my product my be
subject to suspension.
48
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3. I have made offers to share in the cost to develop data (Offers to Cost Share). I understand
that this option is available only for acute toxicity or certain efficacy data and only if EPA
indicates in an attachment to this Data Call-In Notice that my product is similar enough to
another product to qualify for this option. I am submitting evidence that I have made an
offer to another registrant (who has an obligation to submit data) to share in the cost of that
data. I am also submitting a completed " Certification of offer to Cost Share in the
Development Data" form. I am including a copy of my offer and prooof of the other
registrant's receipt of that offer. I am identifying the party which is committing to submit
or provide the require data; if the required study is not submitted on time, my product may
be subject to suspension. I understand that other terms under Option 3 in the Data Call-In
Notice (Section ffl-C.l.) apply as well.
4. By the specified due date, I will submit an existing study that has not been submitted
previously to the Agency by anyone (submitting an Existing Study). I certify that this study
will meet all the requirements for submittal of existing data outlined in option 4 in the Data
Call-In Notice (Section m-C.l.) and will meet the attached acceptance criteria (for acute
toxicity and product chemistry data). I will attach the needed supporting information along
with this response. I also certify that I have determined that this study will fill the dam
requirement for which I have indicated this choice.
5. By the specified due date, I will submit or cite data to upgrade a study classified by the
Agency as partially acceptable and upgrade (upgrading a study). I will submit evidence of
the Agency's review indicating that the study may be upgraded and what information is
required to do so. I will provide the MRID or Accession number of the study at the due
date. I understand that the conditions for this Option outlined Option 5 in the Data Call-In
Notice (Section m-C.l.) apply.
6. By the specified due date, I will cite an existing study that the Agency has classified as
acceptable or an existing study that has been submitted but not reviewed by the Agency
(Citing an Existing Study). If I am citing another registrant's study, I understand that this
option is available only for acute toxicity or certain efficacy data and only if the cited study
was conducted on my product, an identical product or a product which EPA has "grouped"
with one or more other products for purposes of depending on the same data. I may also
choose this option if I am citing my own data. In either case, I will provide the MRID or
Accession number (s) number (s) for the cited data on a "Product Specific Data Report"
form or in a similar format. If I cite another registratrant's data, I will submit a completed
"Certification With Respect To Data Compensation Requirements" form.
7. I request a waiver for this study because it is inappropriate for my product (Waiver
Request). I am attaching a complete justification for this request, including technical
reasons, data and references to relevant EPA regulations, guidelines or policies. [Note: any
supplemental data must be submitted in the format required by P.R. Notice 86-5]. I
understand that this is my only opportunity to state the reasons or provide information in
support of my request. If the Agency approves my waiver request, I will not be require to
49
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supply the data pursuant to Section 3(c) (2) (B) of FIFRA. If the Agency denies my waiver
request, I must choose a method of meeting the data requirements of this Notice by the due
date stated by this Notice. In this case, I must, within 30 days of my receipt of the
Agency's written decision, submit a revised "Requirements Status chosen. I also understand
that the deadline for submission of data as specified by the original data cal-in notice will
not change.
Items 10-13. Self-explanatory.
NOTE: You may provide additional infonnation that does not fit on this fonn in a signed
letter that accompanies this form. For example, you may wish to report that your
product has already been transferred to another company or that you have already
voluntarily cancelled this product. For these cases, please supply all relevant
details so that EPA can ensure that its records are correct
50
-------
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ATTACHMENT D
EPA's Grouping of End-Use Products for Meeting Acute
Toxicology Data Requirements for Reregistration
51
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ATTACHMENTD
EPA*S DECISION NOT TO BATCH END-USE PRODUCTS CONTAINING 10.10*-
Oxvbisphenoxarsine (OBPA) FOR PURJ'PSIES QFMKKTTNG ACUTE TOXICFTY DATA
REOUIREMENTS 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 end-use products containing the active ingredient
OBPA, the Agency considered batching end-use products. This process involves grouping
similar products for purposes of acute toxicity. Factors considered in the sorting process include
each product's active and inert ingredients (identity, percent composition and biological activity),
type of formulation (e.g., emulsifiable concentrate, aerosol, wettable powder, granular, etc.),
and labeling (e.g., signal word, use classification, precautionary labeling, etc.).
However, batching of end-use products containing OBPA was not possible after considering
the available information described above. Table I lists all the end-use products containing
OBPA. These products were either considered not to be similar for pirposes of acute toxicity
or the Agency lacked sufficient information for decision making purpoiies. Registrants of these
products are responsible for meeting the acute toxicity data requirements for each product.
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), and the formulation has not been significantly altered since submission and acceptance
of the acute toxicity data. Regardless of whether new data is generated or existing data is cited,
the registrant must clearly identify the material tested by its EPA registration number.
In deciding how to meet the product specific data requirements, registrants must follow the
directions given in the Data Call-In Notice and its attachments appended to the RED. The DCI
Notice contains two response forms which are to be completed and submitted to the Agency
within 90 days of receipt. The first form, "Data Call-In Response,* asls 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 must select one of the following options:
Developing Data (Option 1), Submitting an Existing Study (Option 4), Upgrading an Existing
Study (Option 5) or Citing an Existing Study (Option 6). Since the end-use products containing
OBPA could not be batched, registrants cannot choose from the remaining options: Cost sharing
(Option 2) or Offers to Cost Share (Option 3).
52
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Table I. End-Use Products Not Batched Containing OBPA
EPA REG. NO.
34688-37
% of OBPA
1.0
Formulation Type
liquid
34688-38 1 2.0 liquid
34688-46 5.0
liquid
34688-49 ' 5.0 > liquid
2829-82 1.0 ; liquid
2829-96
2.0
liquid
2829-102 ! 1.0 j liquid
2829-104
2829-105
1.0
2.0
liquid
liquid
2829-109 < 2.0 j liquid
2829-110
2.0 | liquid
2829-115 J 5.0 j pellets
2829-120 j 96.0 ; powder
2829-125
5.0 j liquid
2829-90 ! 2.0 ! liquid
53
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ATTACHMENT E
EPA Acceptance Criteria
54
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SUBDIVISION D
Guideline
Series 61
Series 62
Series 63
Study Title
Product Identity and Composition
Analysis and Certification of Product Ingredients
Physical and Chemical Characteristics
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61 Product Identity and Composition
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Name of technical material tested (include product name and
trade name, if appropriate)
2. Name, nominal concentration, and certified limits (upper and
lower) for each active ingredient and each intentionally-
added inert ingredient
3. Name and upper certified limit for each impurity or each
group of impurities present at > 0.1% by weight and for
certain toxicologically significant impurities (e.g.,
dioxins, nitrosamines) present at <0.l%
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
-------
8. (continued)
Flow chart with chemical equations for each intended
chemical reaction
Duration of each step of process
Description of purification procedures
Description of measures taken to assure quality of final
product
Discussion of formation of impurities based on established
chemical theory addressing (1) each impurity which may be
present at > 0.1% or was found at > 0.1% by product analyses
and (2) certain toxicologically significant impurities
(see #3)
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61 Product Identity and Composition
GUIDANCE FOR SUMMARIZING STUDIES
The following criteria apply to the technical grade of the active
ingredient being reregistered. Items 1, 2, 3, and 5 can be
satisfied for most registered products by submission of the
Certified Statement of Formula Ingredients Page (EPA Form 8570-4).
Items 7 and 8 can be satisfied for most technical grade active
ingredients (TGAIs) by submission of a flow chart with chemical
equations for each intended chemical reaction. The flow chart
should include complete chemical structures and names for each
reactant and product of all the reactions.
1. Name of technical material (include product name and trade name,
if appropriate).
2. Description of each active and intentionally-added inert
ingredient, including name, concentration, and certified limits.
3. Name and upper limit for all impurities present at > 0.1% and
those toxicologically significant impurities present at <0.1%.
4. The purpose of each active and intentionally-added inert
ingredient.
5. Chemical name and Registry Number for each active and
intentionally-added inert ingredient (if available).
6. Molecular, structural, and empirical formulas, molecular weight,
and any experimental or internal code number for each active
ingredient.
7. Description of each beginning material in the manufacturing
process.
8. Description of manufacturing process.
9. Discussion of formation of impurities based on established
chemical theory.
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62 Analysis and Certification of Product Ingredients
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active
ingredient being reregistered. Use a table to present the
information in items 6, 7, and 8.
Does your study meet the following acceptance criteria?
1. Five or more representative samples (batches in case of
batch process) analyzed for each active ingredient and all
impurities present at > 0.1%
2. Degree of accountability or closure > ca 98%
3. Analyses conducted for certain trace toxic impurities at
lower than 0.1% (examples, nitrosamines in the case of
products containing dinitroanilines or containing secondary
or tertiary amines/alkanolamines plus nitrites;
polyhalogenated dibenzodioxins and dibenzofurans) [Note
that in the case of nitrosamines both fresh and stored
samples must be analyzed.]
4. Complete and detailed description of each «tep in analytical
method used to analyze above samples
5. statement of precision and accuracy of analytical method
used to analyze above samples
6. Identities and quantities (including mean and standard
deviation) provided for each analyzed ingredient
7. Upper and lower certified limits proposed for each active
ingredient and intentionally added inert along with
explanation of how the limits were determined
8. Upper certified limit proposed for each impurity present at
> 0.1% and for certain toxicologically significant
impurities at <0.1% along with explanation of how limit
determined
9. Analytical methods to verify certified limits of each
active ingredient and impurities (latter not required if
exempt from requirement of tolerance or if generally
recognized as safe by FDA) are fully described
10. Analytical methods (as discussed in #9) to verify certified
limits validated as to their precision and accuracy
_l
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62 Analysis and Certification of Product Ingredients
GUIDANCE FOR SUMMARIZING STUDIES
The following criteria apply to the technical grade of the active
ingredient being reregistered.
1. Number of representative samples analyzed for all active
ingredients and all impurities at > 0.1%.
2. Degree of accountability or closure in analyses in item #1.
3. Chemical names of toxic impurities which were analyzed for
levels <0.1%.
4. Brief description(s) of analytical method(s) used to measure
active ingredients and impurities in items #1 and #3.
5. statement of precision and accuracy of method(s) in item #4.
6. Chemical name and quantities observed (range, mean, standard
deviation) for each ingredient (actives and impurities)
analyzed in item #1.
7. Proposed upper and lower certified limits for each active
ingredient and intentionally added inert with brief explanation
of how limits were determined.
8. Proposed upper certified limit for each impurity present at
>=0.1% and certain toxicologically significant impurities at
<0.1% with brief explanation of how limits were determined.
9. Brief description of analytical method(s) used to verify
certified limits (if same methods as item #4, may reference
latter).
10. Statement of precision and accuracy of method(s) in item #9
(may reference item #5 if applicable).
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63 Physical and Chemical Characteristics
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active
ingredient being reregistered.
Does your study meet the following acceptance criteria?
63-2 Color
Verbal description of coloration (or lack of it)
Any intentional coloration also reported in terms of
Munsell color system
63-3 Physical State
Verbal description of physical state provided using terms
such as "solid, granular, volatile liquid"
Based on visual inspection at about 20-25° C
63-4 odor
Verbal description of odor (or lack of it) using terms
such as "garlic-like, characteristic of aromatic
compounds"
Observed at room temperature
63-5 Melting Point
Reported in C°
Any observed decomposition reported
63-6 Boiling Point
Reported in C°
Pressure under which B.P. measured reported
Any observed decomposition reported
63-7 Density, Bulk Density, Specific Gravity
Measured at about 20-25" C
Density of technical grade active ingredient reported in
g/ml fie the specific gravity of liquids reported with
reference to water at 20° C. [Note: Bulk density of
registered products may be reported in Ibs/ft or
Ibs/gallon.]
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63-8 Solubility
Determined in distilled water and representative polar and
non-polar solvents, including those used in formulations
and analytical methods for the pesticide
Measured at about 20-25° C
Reported in g/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 - 25° C)
63-11 Octanol/water Partition Coefficient
Measured at about 20-25° C
Experimentally determined and description of procedure
provided (preferred method-45 Fed. Register 77350)
Data supporting reported value provided
63-12 pH
Measured at about 20 - 25° C
Measured following dilution or dispersion in distilled
water
63-13 Stability
Sensitivity to metal ions and metal determined
Stability at normal and elevated temperatures
Sensitivity to sunlight determined
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63 Physical and Chemical Characteristics
GUIDANCE FOR SUMMARIZING STUDIES
The following criteria apply to the technical grade of the active
ingredient being reregistered.
-
1. Description of color.
2. Description of physical state.
3. Description of odor.
4. Indication of melting point (in Ce).
5. Indication of boiling point (in C°).
6. Indication of density, bulk density, and specific gravity.
7. Indication of solubility.
8. Indication of vapor pressure.
9. Indication of dissociation constant.
10. Indication of octanol/water partition coefficient.
11. Indication of PH.
12. Description of stability.
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SUBDIVISION F
Guideline Study Title
81-1 Acute Oral Toxicity in the Rat
81-2 Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
81-3 Acute Inhalation Toxicity in the Rat
81-4 Primary Eye Irritation in the Rabbit
81-5 Primary Dermal Irritation Study
81-6 Dermal Sensitization in the Guinea Pig
81-7 Acute Neurotoxicity in the Hen
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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 a * are supplemental and may not be required
for every study.
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81-1 Acute Oral Toxicity in the Rat
GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested, e.g. solid, liquid, percent
AI in technical, end-use product, etc.
2. The number of animals/dose/sex tested.
3. Dosing route and regimen.
4. Vehicle used
5. Doses tested and results
6. Individual observations on day of dosing and for at
least 14 days.
7. Summarization of body weights
8. Summarization of gross necropsy
9. Significance of changes from the Acceptance Criteria
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81-2 Acute Dermal toxicity in the Rat, Rabbit or Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc)
2.
3.*
4.
5."
6.*.
7.
8.
9.
10/
11.
12.'
13.'
14."
At least 5 animals/sex/group
Rats 200-300 gin, rabbits 2.0-3.0 kg or guinea pigs 350-
450 gm.
Dosing, single dermal.
Dosing duration at least 24 hours.
Vehicle control, only if toxicity of vehicle is unknown.
Doses tested, sufficient to determine a toxicity category
or a limit dose (2000 mg/kg).
Application site clipped or shaved at least 24 hours
before dosing
Application site at least 10% of body surface area.
Application site covered with a porous nonirritating cover
to retain test material and to prevent ingestion.
Individual observations at least once a day.
Observation period to last at least 14 days.
Individual body weights.
Gross necropsy on all animals.
Criteria marked with a * are supplemental and may not be required
for every study.
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81-2 Acute Dermal Toxicity in the Rat, Rabbi*: or Guinea Pig
GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested, e.g., solid, liquid, percent AI
in technical, end-use product, etc.
2. The number of animals/sex/dose
3. Weight range of animals
4. Verification of single, dermal exposure
5. Duration of dermal exposure
6. Statement of vehicle control
7. Doses tested and results
8. Preparation of application site
9. Area of application site (percent body surface)
10. Occlusion of test material on application site
11. Individual observations on day of dosing and for at
least 14 days or until all animals appear normal (whichever is
longer).
12. Summarization of body weights
13. Summarization of gross necropsy
14. Significance of changes from Acceptance Criteria
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81-3 Acute Inhalation Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc)
2. Product is a gas, a solid which may produce a significant
vapor hazard based on toxicity and expected use or contains
particles of inhalable size for man (aerodynamic diameter
15 urn or less).
3. At least 5 young adult rats/sex/group
4. Dosing, at least 4 hours by inhalation.
5. Chamber air flow dynamic, at least 10 air changes/hour, at
least 19% oxygen content.
6. Chamber temperature, 22° C (±2), relative humidity 40-60%.
7. Monitor rate of air flow
8. Monitor actual concentrations of test material in breathing
zone.
9. Monitor aerodynamic particle size for aerosols.
10. Doses tested, sufficient to determine a toxicity category
or a limit dose (5 mg/L actual concentration of respirable
substance).
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
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81-3 Acute Inhalation Toxicity in the Rat
GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested, e.g., solid, liquid, percent AI
in technical, end-use product, etc.
2. statement of the inhalability of test substance
3. The number of animals/sex/dose
4. Duration of inhalation exposure
5. Number of chamber air changes/hour and the percent oxygen
content of chamber air
6. Ranges for chamber air temperature and relative humidity
7. Air flow rate
8. Analytical concentrations of test material in breathing zone
9. Results of aerosol particle-size determination
10. Doses tested (or limit dose of 5mg/L or highest attainable)
11. Individual observations on day of dosing and for at least 14
days.
12. Summarization of body weights
13. Summarization of gross necropsy
14. Significance of changes from Acceptance Criteria
-------
81-4 Primary Eye Irritation in the Rabbit
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
! Identify material tested (technical, end-use product, etc)
2. Study not required if material is corrosive, causes severe
dermal irritation or has a pH of < 2 or > 11.5.
3. 6 adult rabbits ""
4. Dosing, instillation into the conjunctival sac of one eye
per animal.
5. Dose, O.l ml if a liquid; 0.1 ml or not more than 100 mg if
a solid, paste or particulate substance.
6. Solid or granular test material ground to a fine dust.
7. Eyes not washed for at least 24 hours.
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 a * are supplemental and may not be required
for every study.
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81-4 Primary Eye Irritation in the Rabbit
GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested, e.g., solid, liquid, percent AI
in technical, end-use product, etc.
2. State if material is corrosive, cause severe dermal irritation
or has a pH of <2 or >11.5
3. Number of adult rabbits tested
4. State method of dosing, i.e., instillation into the
conjunctival sac of one eye per animal
5. Dose administered
6. Note whether solid or granular test material has been ground to
a fine dust
7. State whether eyes were washed and at what time post
instillation (not less than 24 hours)
8. State whether eyes were examined and graded for irritation
before dosing and at what periods after dosing
9. Individual daily observations afterwards, until eyes are normal
or for 21 days
10. Significance of changes from Acceptance Criteria
-------
1
81-5 Primary Dermal Irritation Study
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1.
2."
3.
4.'
5."
6.'
7.
8."
9.
10.
11.*
Identify material tested (technical, end-use product, etc}
Study not required if material is corrosive or has a
pH of <2 or > 11.5.
6 adult animals.
Dosing, single dermal.
Dosing duration 4 hours.
Application site shaved or clipped at least 24 hours prior
to dosing
Application site approximately 6 cm.
Application site covered with a gauze patch held in place
with nonirritating tape
Material removed, washed with water, without trauma to
application site
Application site examined and graded for irritation at i,
24, 48 and 72 hr, then daily until normal or 14 days
(whichever is shorter).
Individual daily observations.
Criteria marked with a * are supplemental and may not be required
for every study.
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81-5 Primary Dermal Irritation Study
GUIDANCE FOR SUMMARIZING STUDIES
1. The fora of pesticide tested, e.g., solid, liquid, percent AI
in technical, end-use product, etc.
2. state if material is corrosive, has a pH <2 or >11.5, or has a
dermal LD 50 <200 mg/kg
3. Number of adult animals tested
4. Amount applied
5. Duration of dermal exposure
6. Preparation of application site (shaved or clipped at specified
time before dosing)
7. Area of application site
8. Method for occlusion of application site
9. Note removal of test material and if skin was washed with water
10. State times post application when site was graded for
irritation
11. Individual observations for day of dosing and individual
daily observations thereafter
12. Significance of changes from Acceptance Criteria.
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81-6 Dermal Sensitization in the Guinea Pig
ACCEPTANCE CRITERIA
dose your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc)
2. Study not required if material is corrosive or has a
pH of <2 or > 11.5.
3. One of the following methods is utilized;
Freund's complete adjuvant test
Guinea pig maximization test
Split adjuvant technique
Buehler test
Open epicutaneous test
Mauer optimization test
Footpad technique in guinea pig
4. Complete description of test
5.*. Reference for test.
6. Test followed essentially as described in reference
document.
7. Positive control included (may provide historical data
conducted within the last 6 months)
Criteria marked with a * are supplemental and may not be required
for every study.
-------
81-6 Dermal Sensitization in the Guinea Pig
GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested, e.g., solid, liquid, percent AI
in technical, end-use product, etc.
2. State if material is corrosive or has pH <2 or >11.5.
3. State specific method utilized
4. Complete description of specific method
5. Reference for the specific method employed
6. Note adherence of the protocol to that in the reference for
the specific method utilized
7. state the positive control tested
8. Significance of changes from Acceptance Criteria
-------
_
3.*
8.*
81-7 Acute Neurotoxicity in the Hen
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Study performed on an organophosphate cholinesterase
inhibiting compound.
Technical form of the active ingredient tested.
Positive control utilized.
Species utilized, domestic laying hen 8-14 months of age.
Dosing oral by gavage or capsule (dermal or inhalation
may be used).
An acute oral LD is determined.
Dose tested equal to an acute oral LD or a limit test of
5000 mg/kg.
Dosed animals may be protected with atropine and/or 2-
PAM.
Sufficient test animals so that at least 6 survive.
Negative (vehicle) control group of at least 6 hens
Positive control of at least 4 hens, (if used)
Test dose repeated if no signs of delayed neurotoxicity
observed by 21 days after dosing.
Observation period 21 days after each dose.
Individual daily observations.
Individual body weights.
Individual necropsy not required.
Histopathology performed on all animals. Tissue to be
fixed in sin preferably using whole animal perfusion
techniques. At least three sections of each of the
following tissues:
_brain, including medulla oblongata
"spinal cord; upper cervical, mid-thoracic and
'lumbro-sacral regions
_tibial nerve; proximal regions and branches
'sciatic nerve
Criteria marked with a * are supplemental and may not be required
for every study.
-------
-------
ATTACHMENT F
List of Registrants sent this DCI
55
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ATTACHMENT G
Product Specific Data Call-In Cost Share and
Data Compensation Forms
56
-------
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r/EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
OKI Nft, 2070-0107
2070-0087
Appreval Espitee 9-U-M
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 SU S.W., Washington, DC 20460; and to the Office
of Management and Budget. Paperwork Reduction Project (20704)106). Washington, DC 20503.
Please fill In blanks below.
Company Name
Product HUB*
Company
EPA Re?
Number
f. Mo.
(Certify that
1. 'for each study died in support of registration or reregistration under the Federal Insecticide. Fungicide and
Rodentictie Act (FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained me
written permission of the original data submitter to cite that study.
That for each study cfted 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 tited and have offered to: (a) Pay
compensation for those data in accordance with sections 3(C)(1)(D) and 3(c)(2)(D) of FIFRA; and (b) Commence
negotiation to determine which data are subject to the compensation requirement of FIFRA and the amount of
compensation due, I any. The companies I have notified are: (check one)
U 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)(i)(D) of FIFRA for the studies I have died in support of
registration or reregistration under FIFRA.
Signature
Oat*
Km* a«* T1U* (PiMM Type «r MM)
RAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the
t or reregistration of my products, to the extent required by FIFRA sections 3(C)(1)(D) and 3(c)(2)(D).
Signature ^ .
*
»«.
Hun and Title (Please Type or Print)
-------
&EPA
United Status Environmental Protaetlon Agency
Washington, DC 20460
CERTIFIICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
OMB fcte.
1070-9097
Public reporting burden tor this coBectton of Information is estimated to average 1!5 minutes per response, incfaxfing
time for reviewing instructtons. searching exfattlng 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 bur Jen, 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 (20704106), Washington, DC 20503. .
Please nil in blanks below.
I Certify that:
My company is wiling to develp 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 sliare in the cost of developing
My firm has offered in writing to enter into such an agreement. That offer vras Irrevocable and included an
offer to be bound by arbitration decision under section 3(c)(2)(B){iii) of Fl FRA 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):
Data of Offer
Certification:
I certify that i am duly authorized to represent the company name 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'* Authorized Repraeentatlv*
Oat*
Nam* and Tide (Pleas* Type or Print)
BPA rum sfTfraa (*-»D
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