United States Office of Prevention, Pesticides
Environmental Protection And Toxic Substances June 1992
Agency (H-7608W) PB92-221829
svEPA Reregistration
Eligibility Document
(RED)
/•*•* ' A -J
Citric Acid
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REREGISTRATION ELIGIBILITY DOCUMENT
CITRIC ACID
LISTD
CASE 4024
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
WASHINGTON, D.C.
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EPA CITRIC ACID REREGISTRATION ELIGIBILITY TEAM
Office of Pesticide Programs:
Biological and Econom
Branch
Phyllis Johnson
Ted Czerkowicz
Rafael Prieto
Biological Analysis Branch
Biological Analysis Branch
Biological Analysis Branch
Enyimntnen*at Fate and Effects Division
Roy Bingham Environmental Fate and Ground Water Branch
Martha Sager Science Analysis and Coordination Staff
Charles Lewis Ecological Effects Branch
Health Effects Division
James Yowell Occupational and Residential Exposure Branch
Pat McLaughlin Toxicology Branch JJ
Bonnie Kohlligian Chemistry Branch TJ
Dave Van Onner Science Analysis and Coordination Branch
Program Management and Support Division
BeWanda Alexander Information Services Branch
Registration Division
Sami Malak Registration Support Branch
Ruth Douglas Antimicrobial Program Branch
Mary Waller Registration Support Branch
Bill Wooge Antimicrobial Program Branch
Pat Critchlow Registration Support Branch
Special Review and Reregistration Division
Napoleon Kotey Accelerated Reregistration Branch
Policy and Special Projects Staff
Jean Frane
Office of General Counsel
Mary Jane Angelo
Office of Compliance Monitoring
Beverly Updike
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TABLE OF CONTENTS
Page
GLOSSARY OF TERMS AND ABBREVIATIONS
EXECUTIVE SUMMARY
I. INTRODUCTION
n. CASE OVERVIEW
A. CHEMICAL OVERVIEW
B. USE PROFILE
C. REGULATORY HISTORY
HI. SCIENCE ASSESSMENT OF CITRIC ACID
A. PRODUCT CHEMISTRY ASSESSMENT
B. ENVIRONMENTAL AND HUMAN HEALTH ASSESSMENT
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. DETERMINATION OF ELIGIBILITY
B. ADDITIONAL GENERIC DATA REQUIREMENT
C. LABELING FOR MANUFACTURING-USE PRODUCTS
V. ACTIONS REQUIRED BY REGISTRANTS OF END-USE PRODUCTS
A. DETERMINATION OF ELIGIBILITY
i
1. Product Specific Data Requirements
2. Labeling Requirements for End-Use Products
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2
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VI. APPENDICES
APPENDIX A - Use Patterns Subject to Reregistration
APPENDIX B - Generic Data Requirements for Reregistration of Citric Acid
and Data Citations Supporting Reregistration
APPENDIX C - Citations Considered to be Part of the Data Base
Supporting the Reregistration of Citric acid
APPENDIX D - PR Notice 91-2
APPENDIX £ - Pesticide Reregistration Handbook
APPENDIX F - Product Specific Data Call-In
Attachment A - Chemical Status Sheet
Attachment B - Product Specific DCI Response Forms (Form A) plus
Instructions
Attachment C - Requirements Status and Registrants' Response Forms
(Form B) plus Instructions
Attachment D - EPA Groupings of End-Use Products for Meeting Data
Requirements for Reregistration
Attachment E - EPA Acceptance Criteria
Attachment F - List of all Registrant(s) sent this DCI
Attachment G - Cost Share/Data Compensation Forms
Application for Registration
Page
8
11
15
17
20
42
111
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GLOSSARY OF TERMS AND ABBREVIATIONS
CAS Chemical Abstracts Service
CFR Code of Federal Regulations
CSF Confidential Statement of Formula
EPA U.S. Environmental Protection Agency
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
GRAS Generally Recognized As Safe
MRID Master Record Identification (number). EPA's system of recording and
tracking studies submitted to the EPA.
ppm Parts per Million
RED Reregistration Eligibility Document
IV
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SUMMARY
This Reregistration Eligibility Document (RED) addresses pesticide uses of citric acid.
Citric acid-containing products axe currently registered as disinfectants, sanitizers, fungicides,
and scale remover for use in toilets and food processing equipments. It is intended for either
residential or commercial use. All products containing citric acid as an active ingredient and
registered for these uses are eligible for reregistration.
The U.S. Environmental Protection Agency (EPA) has conducted a review of the
scientific data base and other relevant information supporting the reregistration of citric acid
and has determined that the data base is sufficient to allow EPA to make a reregistration
decision. All applicable toxicology, ecological and environmental effect data requirements
have been waived for this active ingredient. The information and data available to EPA
support the conclusion that the currently registered uses of citric acid will not result in
unreasonable adverse effects to human health and the environment.
Accordingly, EPA has determined that all products containing citric acid as the active
ingredient are eligible for reregistration and will be reregistered when acceptable labeling and
product specific data are submitted and/or cited. Before reregistering each product, the EPA
is requiring that product specific data and revised labeling be submitted by the registrants
within eight months of the issuance of this document. After reviewing these data and the
revised labels EPA will determine whether or not the conditions of FIFRA 3(c)(5) have been
met, that is, whether product composition and labeling are acceptable and the product's uses
will not cause unreasonable adverse effects to humans or the environment. If these
conditions are met EPA will reregister the product. Any end-use products containing citric
acid in combination with other active ingredients will not be reregistered until REDs are
issued for all active ingredients contained in that product.
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide 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 of citric
acid. The document consists of six sections. Section I is the introduction. Section n
describes citric acid, 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 discusses the reregistration decision for citric acid. Section V discusses the
reregistration requirements for citric acid. 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
1 EPA'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 (H7S06C), Office of Pesticide
Programs, EPA, Washington, DC 20460.
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n.
CASE OVERVIEW
A. Chemical Qveryjew
The following active ingredient is covered by this Reregistration Eligibility
Document:
Chemical Name: Citric acid
CAS Registry Number: 77-92-9
Office of Pesticide Programs Chemical Code: 021801
Empirical Formula:
B. Use Profile
The following is information on the registered use with specific use sites and
application methods. A detailed table of eligible uses of citric acid is in Appendix A.
Type of Pesticide:
Use Sites:
Disinfectant, Sanitizer, Virucide, Fungicide, Algicide
INDOOR RESIDENTIAL: Toilets, Urinals, Bathrooms
INDOOR FOOD: Dairy and food processing equipment, Tanks,
Vats, Pails, Pipelines, Closed systems
Pests:
When combined with other active ingredients: Odor-
causing bacteria, Mildew, Pathogenic fungi,
Staphylococcus aureus. Adenovirus type 2, Herpes
simplex type 1, Influenza A2/Hong Kong, Human
Immunodeficiency Virus type 1, Algae
Formulation Types
Registered: End use
Form:
Liquid ready to use, Soluble concentrate/Liquid
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Method and Rates
of Application: Types Of Treatment: Foam application, Immersion,
Circulation method, Spray, Brush-on, Swab
Equipment: Foaming apparatus, Brush
Timing: When needed
Rate of Application: From 208 up to 23000 ppm by
volume
Use Practices
Limitations: None
C.
Reeulatorv Historv
EPA registered the first citric acid-containing products in the early 1970's. The
currently registered products (3) are used as fungicides and bactericides sanitizers, virucides,
and algicides in the sites identified in Section n. B. above. Citric acid is Generally
Recognized As Safe (GRAS) (21 CFR 182.1033) by FDA for use in food.
Under a memorandum of understanding (MOU) issued on December 22, 1971, (36
FR 24234), FDA and EPA defined responsibilites in the regulation of food-contact sanitizing
solutions. FDA approves, under food additive regulations, the use of sanitizers on food-
contact surfaces. EPA defers to FDA for dietary risk assessments. This approval includes
the lexicological and dietary residue assessments. EPA focuses on product chemistry,
efficacy, and applicator risk assessments. Citric acid-containing products registered as
sanitizers for food-contact surfaces fall under this agreement.
CITRIC ACID
TIT.
EPA has reviewed the scientific data base for citric acid primarily relying on
information from published literature submitted by the registrant. These are cited in
Appendix C.
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A. Product Chemistry Assessment
Citric acid occurs naturally in plants and animal tissues and fluids. It may be
produced on an industrial scale by mycological fermentation of carbohydrates such as corn
starch and crude sugar solutions (molasses). Strains of mold used include Asperfittus nifer
and Candida tvpolvtica. Citric acid may also be extracted from citrus fruits and from
pineapple waste. One common method of production is submerged fermentation utilizing
glucose as the carbohydrate source for Asperfittus nifer. The mold, produced under
controlled aseptic conditions, is used in specific quantities to seed the sugar solution, along
with sources of assimilable nitrogen, phosphate, magnesium and various trace minerals.
Citric acid is generally recovered by selectively transferring the citric acid via a
solvent from the aqueous solution containing various by-products to another aqueous solution
in which the citric acid is more concentrated and contains substantially less by-products. The
final processing steps begin with a diluent wash of the aqueous solution by a hydrocarbon
solvent, followed by passage of the acid solution through granular activated-carbon columns.
Effluent from the carbon columns is processed through a conventional sequence of
evaporator-crystallizer steps to complete the manufacturing process. Analysis of citric acid
can be accomplished by the use of a liquid chromatography method.
Citric acid occurs as colorless, translucent crystal or white granular to fine crystalline
powder at room temperature with a strongly acid taste and is odorless. The molecular
weight is 192.12. The melting point is 153°C but it decomposes before boiling. Citric acid
is completely soluble in water and ethanol; but slightly soluble in chloroform, ethyl acetate,
amyl alcohol, amyl acetate and diethyl ether. The loose bulk density ranges from 54-57
Ib/ft3 and specific gravity of a 10 percent solution is 1.035. The pH of citric acid is in the
acidic range, from 0.8 for a 50 percent solution to 2.8 for a 0.1 percent solution. Citric acid
dissociates in solution with a pK, of 4.761.
B. Environmental ^^ Human Health Assessment
EPA has developed a normative set of data requirements, set forth in the regulations
(40 CFR Part 158) and the Agency's Reregistration Phase 2 Technical Guidance Document.
These data requirements must be addressed for pesticide reregistration. These regulations
and the guidance document specify the necessary data based on factors including use sites,
potential environmental and human (dietary and occupational) exposures, product formulation
types, product application methods, and results of initial (Tier 1) studies. Due to the diverse
nature and characteristics of pesticide products and their uses subject to reregistration, the
Agency also recognizes the need to modify the data requirements for specific pesticides,
including waiving certain data requirements because such requirements are inappropriate or
unnecessary for reregistration.
The case-specific approach to waive individual data requirements has served to
identify the appropriate data requirement sets for pesticide products. Further, the Agency
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believes there is a category of pesticide active ingredients for which a broadly reduced set of
data requirements are appropriate for reregistration. Specifically, products in this category
would be exempt from the generic data requirements for toxicology, human exposure,
ecological effects, and environmental fate on the active ingredient. The Agency believes
there are numerous considerations which, when taken together, can form the basis for a
conclusion that such a reduction in data requirements is appropriate for a particular pesticide
active ingredient, while not compromising human health or environmental safety.
There are, however, certain data requirements which are essential and may not be
waived. Basic chemistry data on the active ingredient and formulated products are required
for pesticides in this category so that the Agency has reasonable certainty of the pesticide's
identity and chemical/physical characteristics. Also, acute toxicology studies for formulated
products are required for the Agency to determine appropriate product labeling for potential
hazards to those who handle or apply such products. However, these toxicology studies may
be waived if an assessment of the product formulation, including the inert ingredients,
indicates that such studies are unnecessary to prescribe appropriate labeling.
In considering citric acid for reregistration eligibility, the Agency believes it is an
active ingredient that should be considered for this broad waiver of the generic data
requirements. The considerations that lead the Agency to this conclusion are as follows:
The U.S. FDA lists citric acid as a multiple purpose "generally recognized as safe"
(GRAS) food substance (21 CFR part 182). Citric acid is also approved by the Joint
FAO/WHO Expert Committee on Food Additives for use in foods without limitation.
There is no indication in the available information on citric acid as provided by the
registrant that suggests that citric acid would constitute a hazard to the public or to the
environment. Citric acid is widely distributed in plants and animals and occurs naturally in
foods in substantial quantities. It is a well-known intermediate in carbohydrate metabolism
and ingested citrate is considered to be completely metabolized.
Citric acid from living organisms is found naturally in soil and water. Citrates
leached from rotting vegetation and produced by microorganisms have been detected at low
levels throughout the ecosystem. Citric acid degrades readily when in contact with a variety
of microorganisms that are found in soil, natural waters or sewage treatment systems. There
is negligible human and environmental exposure to citric acid as a pesticide as a result of
current registered use patterns, e.g., it has a low use rate and frequency of application.
, No reports of adverse effects have been submitted to the Agency for this active
ingredient. Citric acid, is, however, a severe eye irritant and a moderate skin irritant, so
appropriate label precautions are necessary. There is no indication of any other
significant adverse effects from citric acid to humans or the environment associated with its
use as a pesticide.
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Based on these factors die Agency does not believe generic data beyond those data
required to satisfy basic product identity and chemistry questions (refer to Appendix B) are
necessary to determine if the current registered uses of this active ingredient pose
unreasonable risks to humans or the environment. Therefore, the Agency waived all generic
data requirements except the basic product identity and chemistry data. The Agency believes
that, based on the above factors, the registered uses of citric acid do not pose unreasonable
risks to humans or the environment.
IV. RISK MANAGEMENT AND RFRFfTTSTR ATION DECISION FOR CITRIC ACID
A. Determination
Section 4(g)(2)(A) of FIFRA requires the Agency to determine, after consideration of
relevant data concerning an active ingredient whether products containing the active
ingredient are eligible for reregistration. For products containing citric acid as an active
ingredient the Agency waived all generic data requirements except for those basic product
identity and chemistry. These data were submitted and reviewed. In addition to these data,
the Agency has considered the factors discussed above in Section in regarding citric acid's
natural occurrence, common use as a food item, and the lack of reported adverse effects
information. The Agency has completed its consideration of these data and other factors and
has determined this information is sufficient to support reregistration of products containing
citric acid as an active ingredient. The reregistration of particular products is addressed in
Section V of this document.
Although the Agency has concluded that products containing citric acid are eligible
for reregistration, the Agency may take regulatory actions in the future that would affect the
continued registration of citric acid-containing products if significant information about this
active ingredient and/or its products comes to the Agency's attention. Such regulatory action
could include requiring the submission of additional data if the data requirements for
registration (or the guidelines for generating such data) change.
B. Additional Generic Data Requirements
The generic data base supporting the reregistration of products containing citric acid
has been reviewed and determined to be substantially complete for reregistration. No further
generic data are required.
C. LilfrcIJTlg Requirements For Manufacturing-Use Products Of Citric Acid
No manufacturing-use products are registered.
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V. ACTIONS RFOf flRFP BY REGISTRANTS OF END-TOE PRODUCTS
A.
Determination Of Elicibilitv
Based cm the reviews of the generic data for the active ingredient citric acid, the
products containing this active ingredient axe eligible for reregistration. Section 4(g)(2)(B) of
HFRA calls for die Agency to obtain any needed product-specific data regarding the
pesticide after a determination of eligibility has been made. The Agency will review these
data when they have been submitted and/or cited and determine whether to reregister
individual products.
1. Product Specufic Data Requirements
The product-specific data requirements are slated in Attachment C.
2.
Reuirements For End-Use Products
The labels and labeling of all products must comply with the Agency's current
regulations and requirements. Follow the instructions in the Product Reregistration
Handbook with respect to labels and labeling.
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APPENDIX A
Citric Acid Use Patterns Subject to Registration
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APPENDIX B
Generic Data Requirements for Reregistration of Citric Acid and
Data Citations Supporting Reregistration
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GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the rercgistration for the
pesticide covered by this Reregistration Eligibility Document.
Appendix B contains generic data requirements that apply to the pesticide in all products,
including data requirements for which a "typical formulation" is the test substance.
The data tables generally are organized according to the following format:
l.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 out in the Pesticide Assessment Guidelines, which are available from the
National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161.
2.Bibliographic citation (Column 2). If the EPA 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 Appendices for a complete citation of the study.
12
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APPENDIX B
Generic Data Supporting Guideline Requirements for
Reregistration of Citric acid
Requirement
Citric acid
citation
61-1 Chemical Identity (1)
61-2(a) Description of starting material
and manufacturing process (1)
61-2(b) Discussion of formation of
impurities (1)
62-1 Preliminary analysis of product
samples (1)
62-3 Analytical methods to verify
certified limits (1)
63-2 Color (1)
63-3 Physical State (1)
63-4 Odor (1)
63-5 Melting Point (1)
63-6 Boiling Point (1)
63-7 Density, bulk density, or specific
gravity (1)
63-8 Solubility (1)
63-10 Dissociation Constant (1)
63-12 pH (1)
63-13 Stability (1)
(1) For all requirements, information was obtained from product chemistry literature, and
the specification sheet submitted in response to Phase m reregistration package.
13
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ECOLOGICAL
O
EPA waived 40 CFR Part 158 requirements for reasons discussed in section m.
TOXICOLOGY
EPA waived 40 CFR Fart 158 generic requirements for reasons discussed in section
FATE
EPA waived 40 CFR Part 158 requirements for reasons discussed in section m.
RESTPTJE CHEMISTRY
EPA waived 40 CFR Part 158 requirements for reasons discussed in section m.
HUMAN EXPOSURE
EPA waived 40 CFR Part 158 requirements for reasons discussed in section HI.
The citations listed in the bibliography (Appendix C) were used to support these decisions.
u
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APPENDIX C
Citations Considered to be Part of the Data Base
Supporting the Registration of Citric Acid
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OFFICE OF PESTICIDE PROGRAMS
REREGISTRATION ELIGIBILITY DOCUMENT
BIBLIOGRAPHY
CONTENT OF BIBLIOGRAPHY. This bibliography contains citations of all publications
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere in the
Reregistration Eligibility Document. Primary sources for published literature in this
bibliography have been the body of data submitted to EPA in support of past regulatory
decisions.
(1) Sax, N. I., and Lewis, R. J. SR, 1989. Dangerous Properties of Industrial Materials. 7th
Edition. Van Nostrand Reinhold, New York.
(2) Clayton, G. D., and Clayton, F. E., eds., 1982. Patty's Industrial Hygiene and
Toxicology. 3rd Revised Edition. Wiley Interscience, NY.
(3) FASEB, 1977. "Evaluation of the Health Aspects of Citric Acid, Sodium Citrate,
Potassium Citrate, Calcium Citrate, Ammonium Citrate, Triethyl Citrate, Isopropyl Citrate,
and Stearyl Citrate as Food Ingredients* SCOGS-84.
(4) The Merck Index. Eleventh edition 1989 p. 363. Merck & Co., Inc.
(5) Encyclopedia of Chemical Technology. Third edition, Vol. 6. A. Wiley Interscience, NY.
16
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APPENDIX D
PR Notice 91-2
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1
UNffID STATES ENVIRONMENTAL PROTECTION AGENCY
WASWNOTOM, D.C. 204(0
FRMOTXCB tl-2 PMISKS1CODC
SUMTANCCS
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.
.-IX. 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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2.
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). Zn 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 arsenic, metallic xinc, salt of an1
acid). Zn addition, the requirement for performing sample analyses
of five or more representative samples must be fulfilled. Copies of
the raw analytical data must be submitted with the nominal
ingredient label claim. Further information about the analysis
requirement may be found in the 40 CFR 158.170. All products are
required to provide certified limits for each active, inert
ingredient, impurities of toxicological significance(i.e., upper
limit (s) only) and on a case by case basis as specified by EPA.
These limit* are to bo 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
bo changed to nominal concentration.
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IV. PRODUCTS THAT REQUIRE EFFICACY DATA
All pesticides are required to be efficacious. Therefore,
the certified lover limits may not be lover 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 158.640.
In those cases where efficacy limits have been established,
the Agency will not accept certified lover limits vhich are below
that level for the shelf life of'the product.
V. COMPLIANCE SCHEDULE
As described earliar, 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., reregistratlon, nev 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 l, 1991, all nev product
registrations submitted to the Agency
are to comply with the requirements of this
Notice.
(2) Registrants having products subject to
reregistration under FZFRA section 4(a) are to
comply with the requirements of this Notice when
specific products ere called in by the Agency
under Phase V of the Reregistratlon Program.
(3) All other products/applications that are
not subject to (1) and (2) above vill have until
July 1, 1997, to comply with this Notice.
Such applications should note "Conversion
to Nominal Concentration" on the application
form. These types of amendments vill not be
handled as "Fast Track" applications but
vill be handled as routine requests.
VI. FOR FURTHER INFORMATION
Contact Tyrone Aiken for information or questions concerning
this notice on (703) 557-5024.
— £
Anne B. Lindsay, Director
Registration Division (H-7505
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APPENDIX E
Pesticide Reregistration Handbook
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APPENDIX F
Product Specific Data Call-In
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(g)
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
DATA CALL-IN NOTICE
CERTIFIED MAIL
OFFICE OF
PESTCCES AND TOXIC
SUBSTANCES
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 III-D).
If you do not respond to this Notice, or if you do not
satisfy EPA that you will comply with its requirements or should
be exempt or excused from doing so, then the registration of your
product(s) subject to this Notice will be subject to suspension.
We have provided a list of all of your products subject to this
Notice in Attachment 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 12-31-92).
AMMT on RteydM Pv»'
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This Notice is divided into six sections and seven
Attachments. The Notice itself contains information and
instructions applicable to all Data Call-in Notices. The
Attachments contain specific chemical information and
instructions. The six sections of the Notice are:
Section I
Section II
Section III
Why You Are Receiving This Notice
Data Required By This Notice
Compliance With Requirements Of This
Notice
Section IV - Consequences Of Failure To Comply With
This Notice
Section V - Registrants* Obligation To Report
Possible Unreasonable Adverse Effects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
A
B
C
D
E -
F
G
Data Call-in Chemical Status Sheet
Data Ca 3,1 -In Response Form
Requirements Status and Registrant's Response Form
Groupino of End— Use Products for Meeting Acute
Toxicology Data Requirements for Rereaj.strqtion
EPA Acceptance Criteria
frist of Registrants Receiving This Notice
Cost Share and Data Compensation Forms f and Product
Specific Data Report Form
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active
ingredient and reevaluated the data needed to support continued
registration of the subject active ingredient. The Agency has
concluded that the only additional data necessary are product
specific data. No additional generic data requirements are being
imposed. You have been sent this Notice because you have
product(sj containing the subject active ingredient.
SECTION II. DATA REQUIRED BY THIS NOTICE
II-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.
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II-B. ffTHEPVIrE FOR SUBMISSION 9F DATA
You are required to submit the data or otherwise satisfy the
data requirements specified in Attachment C, Requirements status
and Registrant's Response Fora, within the timeframes provided.
II-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in
accordance with test standards outlined in the Pesticide Assessment
Guidelines for those studies for which guidelines have been
established.
•r
'• 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 i 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 3fclf21fBl NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-In does not in
anv way supersede or change the requirements of any previous Data
Call-infsi. 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
6 OF THIS NOTICE
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
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your products. This and other bases for issuance of NOZS due to
failure to comply with this Notice are presented in Section IV-A
and IV-B.
3:iI-8. 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 choose the Voluntary
Cancellation option is presented below. A discussion of the
various options available for satisfying the product specific data
requirements of this Notice is contained in Section III-C. 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 Respopse Form in
Attachment B). Please note that the company's authorized
representative is required to sign the first page of the Data Call-
Ir. Response Form and Requirements Status and Registrant's Response
fern (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 pataCall-in Response Form. indicating your
election of this option. Voluntary cancellation is item number 5
on the Data Call-In Response Form. If you choose this option, this
is the only form that you are required to complete.
If you choose to voluntarily cancel your product, further sale
and distribution of your product after the effective date of
icancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-c.
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2. Satisfying the Product Specific Data,Requirements of
Notice. There are various options available to satisfy the product
specific data requirements of this Notice. These options are
discussed in Section III-C of this Notice and comprise options l
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 this option, you must
submit both forms as well as any other information/data pertaining
to the option chosen to address the data requirement.
Iir-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 option 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.11 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.
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The time frames in the Requirements Status and Registrant' s
Response Form are the tine 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 Agency which
includes: (1) a detailed description of the expected difficulty and
(2) a proposed schedule including alternative dates for meeting
such requirements on a step-by-step basis. You must explain any
technical or laboratory difficulties and provide documentation from
the laboratory performing the testing. While EPA is considering
your request, the original deadline remains. The Agency will
respond to your request in writing. If EPA does not grant your
request, the original deadline remains. Normally, extensions can
be requested only in cases of extraordinary testing problems beyond
the expectation or control of the registrant. Extensions will not
be given in submitting the 90-day responses. Extensions will not
be considered if the request for extension is not made in a timely
fashion; in no event shall an extension request be considered if it
is submitted at or after the lapse of the subject deadline.
Option—2., Agree to Share in Cost to Develop Data —Registrants
may only choose this option for acute toxicity data and certain
efficacy data and only if EPA has indicated in the attached data
tables that your product and at least one other product are similar
for purposes of depending on the same data. If this is the case,
data may be generated for just one of the products in the group.
The registration number of the product for which data will be
submitted must be noted in the agreement to cost share by the
registrant selecting this option. If you choose to enter into an
agreement to share in the cost of producing the required data but
will not be submitting the data yourself, you must provide the name
of the registrant who will be submitting the data. You must also
provide EPA with documentary evidence that an agreement has been
formed. Such evidence may be your letter offering to join in an
agreement and the other registrant's acceptance of your offer, or a
written statement by the parties that an agreement exists. The
agreement to produce the data need not specify all of the terms of
the final arrangement between the parties or the mechanism to
resolve the terms. Section 3(c)(2)(B) provides that if the parties
cannot resolve the terms of the agreement they may resolve their
differences through binding arbitration.
Option 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
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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 6. In addition, you must demonstrate 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 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 . Sufcffl)i^tina 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.
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8
To meet the requirements of the OCX Notice for submitting an
existing study, all of the following three criteria must be clearly
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.11 The term "specimens", according to 40
CFR 160. 3 (k) , means "any material derived from a test system
for examination or analysis."
b. Health and safety studies completed after May 1984 must also
contain all GLP-reguired quality assurance and quality control
information, pursuant to the requirements of 40 CFR Part 160.
Registrants must also certify at the time of submitting the
existing study that such GLP information is available for post-
May 1984 studies by including an appropriate statement on or
attached to the study signed by an authorized official or
representative of the registrant.
c. You must certify that each study fulfills the acceptance
criteria for the Guideline relevant to the study provided inx^^^,^
the FIFRA Accelerated Reregistration Phase 3 Technical Guidance A
and that the study has been conducted according to the
Pesticide Assessment Guidelines (PAG) or meets the purpose of
"the PAG (both available from NTIS) . A study not conducted
according to the PAG may be submitted to the Agency for
consideration if the registrant believes that the study clearly
meets the purpose of the PAG. The registrant is referred to 40
CFR 158.70 which states the Agency's policy regarding
acceptable protocols. If you wish to submit the study, you
must, in addition to certifying that the purposes of the PAG
are met by the study, clearly articulate the rationale why you
believe the study meets the purpose of the PAG, including
copies of any supporting information or data. It has been the
Agency's experience that studies completed prior to January
1970 rarely satisfied the purpose of the PAG and that necessary
raw data are usually not available for such studies.
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If you submit an existing study, you Must certify that the
study aeets all requirements of the criteria outlined above.
It you know of a study pertaining to any requirement in this
Notice which does not meet the criteria outlined above but does
contain factual information regarding unreasonable adverse effects,
you must notify the Agency of such a study. If such study is in
the Agency's files, you need only cite it along with the
notification. If not in the Agency's files, you must submit a
summary and copies as required by PR Notice 86-5.
, Option 5. Upgrading a study ~ If a study has been classified
as partially acceptable and upgradeable, you may submit data to
upgrade that study. The Agency will review the data submitted and
determine if the requirement is satisfied. If the Agency decides
the requirement is not satisfied, you may still be required to
submit new data normally without any time extension. Deficient,
but upgradeable studies will normally be .classified as
supplemental. However, it is important to note that not all
studies classified as supplemental are upgradeable. If you have
questions regarding the classification of a study or whether a
study may be upgraded, call or write the contact person listed in
Attachment A* If you submit data to upgrade an existing study you
must satisfy or supply information to correct all deficiencies in
the study identified by EPA. You must provide a clearly
articulated rationale of how the deficiencies have been remedied or
corrected and why the study should be rated as acceptable to EPA.
Your submission must also specify the MRID number(s) of the study
which you are attempting to upgrade and must be in conformance with
PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a
study classified as unacceptable and determined by the Agency as
not capable of being upgraded.
This option should also be used to cite data that has been
previously submitted to upgrade a study, but has not yet been
reviewed by the Agency. You must provide the MRID number of the
data submission as well as the MRID number of the study being
upgraded.
The criteria for submitting an existing study, as specified in
Option 4 above, apply to all data submissions intended to upgrade
studies. Additionally your submission of data intended to upgrade
studies must be accompanied by a certification that you comply with
each of those criteria as well as a certification regarding
protocol compliance with Agency requirements.
Option 6. Citing Existing Studies --If you choose to cite a
study that has been previously submitted to EPA, that study must
have been previously classified by EPA as acceptable or it must be
a study which has not yet been reviewed by the Agency. Acceptable
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10
toxicology studies generally will have been classified as "core-
guideline" or "core minimum.11 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
o:f 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
s-:ate 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 will grant a waiver
o:ily under extraordinary circumstances. You should also be aware
that submitting a waiver request will not automatically extend the
due date for the study in question. Waiver requests submitted
without adequate supporting rationale will be denied and the
original due date will remain in force.
IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products
s-ibject to this Notice due to failure by a registrant to comply
with the requirements of this Data Call-in Notice, pursuant to
FIFRA section 3(c)(2)(B). Events which may be the basis for
issuance of a Notice of Intent to Suspend include, but are not
limited to, the following:
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11
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 if 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 if required by this Notice.
4 . Failure to submit on the required schedule acceptable
data as required by this Notice.
5. Failure to take a required action or submit adequate
.-• information pertaining to any option chosen to address the data
/requirements (e.g., any required action or information
• pertaining to submission or citation of existing studies or
'offers, arrangements, or arbitration on the sharing of costs or
the formation of Task Forces, failure to comply with the terms
of an agreement or arbitration concerning joint data
development or failure to comply with any terms of a data
waiver) .
6. Failure to submit supportable certifications as to the
conditions of submitted studies, as required by Section III-c
of this Notice.
7. Withdrawal of an offer to share in the cost of developing
required data.
8. Failure of the registrant to whom you have tendered an offer
to share in the cost of developing data and provided proof of
the. registrant's receipt of such offer either to:
a. Inform EPA of intent to develop and submit the data
required by this Notice on a pata gall-In Response Form and a
Requirements Status and Registrant's Response Form;
b. Fulfill the commitment to develop and submit the data as
required by this Notice; or
• c. otherwise take appropriate steps to meet the requirements
stated in this Notice, unless you commit to submit and do
submit the required data in the specified time frame.
9. Failure to take any required or appropriate steps, not
mentioned above, at any time following the issuance of this
Notice.
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
The Agency may determine that a study (even if submitted within
the required time) is unacceptable and constitutes a basis for
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12
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 (if
• '' applicable), 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 CANpEfrMfP PROPffCT.S
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
wr:h this Notice should be permitted, you have the burden of
clearly demonstrating to EPA that granting such permission would be
consistent with the Act. You must also explain why an "existing
stocks" provision is necessary, including a statement of the
quantity of existing stocks and your estimate of the time required
for their sale, distribution, and use. Unless you meet this burden
the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after
suspension.
If you request a voluntary cancellation of your product(s) as a
response to this Notice and your product is in full compliance with
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13
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
vill allow persons other than the registrant such as independent
distributors, retailers and end users to sell, distribute or use
such existing stocks until the stocks are exhausted. Any sale,
distribution or use of stocks of voluntarily cancelled products
containing an active ingredient for which the Agency has particular
risk concerns will be determined on a case-by-case basis.
Requests for voluntary cancellation received altfit the 90 day
response period required by .this Notice will not result in the
Agency granting any additional time to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was
due unless you demonstrate to the Agency that you are in full
compliance with all Agency requirements, including the requirements
of this Notice. For example, if you decide to voluntarily cancel
your registration six months before a 3 year study is scheduled to
be submitted, all progress reports and other information necessary
to establish that you have been conducting the study in an
acceptable and good faith manner must have been submitted to the
Agency, before EPA will consider granting an existing stocks
provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT
UNREASONABLE ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6 (a) (2) states that
if at any time after a pesticide is registered a registrant has
additional factual information regarding unreasonable adverse
effects on the environment by the pesticide, the registrant shall
submit the information to the Agency. Registrants must notify the
Agency of any factual information they have, from whatever source,
including but not limited to interim or preliminary results of
studies, regarding unreasonable adverse effects on man or the
environment. This requirement continues as long as the products
are registered by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and
procedures established by this Notice, call the contact person(s)
listed in Attachment A, the Data Call-In Chemical Status Sheet.
All responses to this Notice (other than voluntary cancellation
requests) must include a completed Data Call-In Response Fora and a
completed Requirements Status and Registrant's Response Form
(Attachment B and Attachment C) 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 option is
chosen, only the Data Call-In Response Form need be submitted.
-------
14
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,
A •
B •
C -
D •
E -
F -
G -
.Daniel M. Barolo, Director
..'•• Special Review and
Reregistration Division
Attachments
Data Call-In Chemical Status Sheet
Data Call-In Response Form
Requirements Status and Registrant's Response Form
EPA Grouping of End-Use Products for Meeting Acute
Toxicology Data Requirements for Rerecristration
EPAAcceptance Criteria
List of Registrants Receivipg This Notice
Cost Share and Data Compensation Forms, and Product
Specific Data Report Form
-------
ATTACHMENT A
Chemical Status Sheet
-------
ATTACHMENT A
CITRIC ACID: DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Data Call-In Notice because you have products containing
citnc acid.
This attachment, the Data
Status Sheet, contains a point of contact for
inquiries. This attachment is to be used in conjunction with (1) the Data Call-In Notice. (2)
Attachment B, the Data Call-In Response Form,. (3) Attachment C, the Requirement Status and
Registrant's Response Form for product specific data, (4) Attachment D, EPA Grouping of
End-Use Products for Meeting Acute Toxicology Data Requirements for Reregistration. (5)
Attachment E, EPA Acceptance Criteria. (6) Attachment F, List of j^fl Registrants) sfrnt this
Data Call-In Notice, and (7) Attachment G, the Cost Share and Data Compensation Forms for
product specific data, and Product Specific Data Report Form for use in replying to this citric
acid Data Call-In. Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for citric acid are
listed in the Requirements Status and Registrant's Response Form. Attachment C.
The Agency has concluded that product specific data are needed for citric acid. The
required additional data are listed in Attachment C.
Depending on the results of the studies required in this Notice, additional testing may
be required.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the product specific data requirements and
procedures established by this Notice, please contact Ruth Douglas at (703) 305-6600. All
responses to this Notice should be submitted to:
Document Processing Desk (RED/RD/PM-32)
Office of Pesticide Programs
U.S. Environmental Protection Agency
401 M Street S.W.
Washington, D.C. 20460
RE: Citric acid
-------
If you have any questions regarding the generic data requirements and procedures
established by this Notice, please contact Napoleon Kotey at (703) 308-8523. All responses to
this Notice should be submitted to:
Chemical Review Manager Napoleon Kotey
Accelerated Reregistration Branch (H7508W)
Special Review and Reregistration Division
Office of Pesticide Programs
U.S. Environmental Protection Agency
401 M Street S.W.
Washington, D.C. 20460
RE: Citric acid
-------
ATTACHMENT B
PRODUCT SPECIFIC DATA CALL-IN RESPONSE FORMS (Form A)
PLUS INSTRUCTIONS
-------
* -. «.
SPECIFIC INSTRUCTIONS FOR COMPLETING
THE DATA CALL-IN RESPONSE FORK
Product Specific Data
This fonn is designed to be used to respond to call-ins for
generic and product specific data for the purpose of
reregistering pesticides under the Federal Insecticide Fungicide
and Rodenticide Act. Fill out this form each time you are
responding to a data call-in for which EPA has sent you the form
entitled "Requirements Status and Registrant's Response."
Items 1-4 will have been preprinted on the form. Items 5
through 7 must be completed by the registrant as appropriate.
Items 8 through 11 must be completed by the registrant before
submitting a response to the Agency.
Public reporting burden for this collection of information
is estimated to average 15 minutes per response, including time
for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and
reviewing the collection of information. Send comments regarding
the burden estimate or any other aspect of this collection of
information, including suggesting for reducing this burden, to
Chief, Information Policy Branch, PM-223, U.S. Environmental
Protection Agency, 401 H St., S.w., Washington, D.C. 20460; and
to the Office of Management and Budget, Paperwork Reduction
Project 2070-0107, Washington, D.C. 20503.
-------
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INSTRUCTIONS FOR COMPLETING THE "DA* A 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 (MP)
or 7b (EP) on this form, provide the EPA registration
numbers of your source(s) and complete and submit the
"Generic Data Exemption" form; 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 (MP) for which you
wish to maintain registration, you must agree to
satisfy the data requirements by responding "yes."
Itejn -7b. For each end use product (EP) for which you wish to
maintain registration, you must agree to satisfy the
data requirements by responding "yes." If you are
requesting a data waiver, answer "yes" here; in
addition, on the "Requirements Status and Registrant's
Response" form under Item 9, you must respond with
Option 7 (Waiver Request) for each study for which you
are requesting a waiver. See Item 6 with regard to
identical products and data exemptions.
Items 8-11. Self-explanatory.
NOTE; You may provide additional information that does not
fit on this form in a signed letter that accompanies
this form. For example, you may wish to report that
( - your product has already been transferred to another
company or that you have already voluntarily cancelled
this product. For these cases, please supply all
relevant details so that EPA can ensure that, its
records are correct.
-------
ATTACHMENT C
PRODUCT SPECIFIC REQUIREMENT STATUS AND REGISTRANT'S RESPONSE
(FORMS B) PLUS INSTRUCTIONS
AND
PR NOTICE 86-5
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-------
SPECIFIC INSTRUCTIONS FOR COMPLETING
THE REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE FORM
Product Specific Pate
• This form is designed to be used for registrants to respond
to call-ins for generic and product-specific data as part of
EPA's reregistration program under the Federal Insecticide
Fungicide and Rodenticide Act. Although the form is the saae for
both product specific and generic data, instructions for
completing the forms differ slightly. Specifically, options for
satisfying product specific data requirements do not include (1)
deletion of uses or (2) request for * low volume/minor use
waiver. These instructions are for completion of product
specific data requirements.
EPA has developed this form individually for each data call-
in addressed to each registrant, and has preprinted this form
with a number of items. DO NOT use this form for any other
active ingredient.
Items 1 through 8 (inclusive) will have been preprinted on
the form. You must complete all other items on this form by
typing or printing legibly.
Public reporting burden for this collection of information
is estimated to average 30 minutes per response, including time
for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and
reviewing the collection of information. Send comments regarding
the burden estimate or any other aspect of this collection of
information, including suggesting for reducing this burden, to
Chief, Information Policy Branch, FM-223, U.S. Environmental
Protection Agency, 401 N St., S.W., Washington, O.C. 20460; and
to the Office of Management and Budget, Paperwork Reduction
Project 2070-0107, Washington, D.C. 20503.
-------
INSTRUCTIONS POR -COMPLETING THE "REQUIREMENTS STATUS
REGISTRANT'S RESPONSE" FORM FOR PRODUCT SPECIFIC DATA . .
AND
Itea 1-3 Completed by EPA. Not* tha waique identifier auaber
assigned by EPA in Itea 3. This number Bust be use* ia
tee traasaittal docuaeat for any data subaissioas in
r*spons* to this Data Call-in Notiee.
• • . •
Itea 4.. The guidelina reference Jiuabers of studies raquired to
support tha product's eontinuad registration ara
idantifiad. These guidelines, in addition to tha
requireaents spaeifiad in tha Notiea, govern tha conduct
of tha raquirad studias. Nota that sarias 61 and 62 in
product chemistry ara now listad under 40 CFR 158.155
through 150. ISO, Subpart C.
Itea 5. Tha study titla associated with tha guidalina rafaranea
number is idantifiad.
Ztaa 6. Tha usa pattern(s) of tha pesticide assoeiatad with tha
product spacifie requirements is (ara) idantifiad. For
nost product spacifie data requirements, all usa pattarns
ara covarad by tha data requireaents. In tha easa of
afficacy data, tha raquirad studias only pertain to
products which hava tha usa sitas and/or pasts indieatad.
•
Item 7. Tha substance to ba tastad is idantifiad by EPA. For
product specific data, tha product as formulated for sala
and distribution is tha test substanea, except in rara
casas. . • • ••
Ztaa 8. Tha dua data for submission of aach study is idantifiad.
It is normally based on 8 aoaths. after issuance of tha
ReregistratioD Eligibility Bocuaeat unless EPA^datarainas
that a longer tiaa period is necessary.
Itaa 9. Eater e«lve«e of the following raspoase codes for each
data requirement to show how you intend to eoaply with
tha data requirements listed ia this table. Fuller
descriptions of aach option ara contained in tha Data
Call-In Notice.
1. I will generate and submit data by tha specified dua data
(Developing Data) . By indicating that I hava chosen this
i option, I certify that I will eoaply with all tha
requirements pertaining to tha conditions for subaittal
of this study as outlined in tha Data Call-In Notiea.
*
2. I hava entered into an agreeaent with ona or acre
registrants to develop data jointly (Cost Sharing). I
aa submitting a copy of this agraaaeat and a eoaplatad
"Certification With Respect To Data Compensation
Requireaeats" fora. I understand that this option is
available only for acute toxicity or certain afficacy
-J
-------
data and only if EPA indicates in an attachment to this
Notice that ay product is similar enough to another
product to qualify for this option. . Z 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, ay product may be subject to
suspension. * • . • . . ' .' .
3. Z have Bade offers to share in the cost to develop data
COffers to Cost Share). Z 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. Z aa
submitting evidence that Z have made aa offer to another
registrant (who has an obligation to submit data) to
share in the cost of that data. Z aa also submitting a
completed "Certification of Offer to Cost Share in the
Development Data" fora. Z aa including a copy of ay
offer and proof of the other registrant's receipt of that
•offer. I am identifying the party which is committing
to submit or provide the required data; if the required
study is not submitted on time, ay product may be subject
to suspension. Z understand that other terms under
Option 3 in the Data Call-in Notice (Section ZIZ-C.l.)
apply as veil.
4. By the specified due date, Z vill submit an existing
study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study). Z
certify that this study vill aeet all the requirements
for subnittal of existing data outlined in Option 4 in
the Data Call-in Notice (Section ZZZ-C.l.) and vill aeet
the attached acceptance criteria (for acute toxicity and
product chemistry data). Z vill attach the needed
supporting information along with this response. Z also
certify that Z have determined that this study vill fill
the data requirement for which Z have indicated this
choice.
t
£. By the specified due data, Z vill submit or cite data to
upgrade a study classified by the Agency as partially
acceptable and upgradable (Upgrading a Study).* Z vill
submit evidence of the Agency»s reviev indicating that
the study may be upgraded and what information is
required to do so. Z vill provide the MRID or Accession
number of the stud? at the due date. Z understand that
the conditions for this option outlined Option 5 in the
Data Call-in Notice (Section IZZ-C.l.) apply.
6. By the'specif ied due date, Z vill 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 aa citing
-------
1 another registrant's study, I understand that this option
•is available only for acute toxicity or certain efficacy
data and oaly if the cited study was. conducted on ay
.product, an identical product or a product which EPA has
'"grouped" with one or acre other products for purposes
of depending on the same data. I nay also choose this
option if Z aa citing ay own data. In either case, I
Jvill provide the 10RXO or Accession cumber(•) for the
cited, data on a "Product Specific Data Report* fora or
in a similar format. Zf Z cite another, registrant's
data, Z vill submit a completed "Certification with
Respect TO Data Condensation Requirements" fora.
• . *
7. Z request a vaiver for. this study because it is
inappropriate for ay product (Waiver Request). Z aa
attaching a complete justification for this request,
including technical reasons, data and references to
relevant EPA regulations, guidelines or policies. {Note:
any supplemental data Bust be submitted in the format
required by P.R. Notice 86-5]. Z understand that this
is ay only opportunity to state the reasons or provide
information in support of ay request. Zf the Agency
approves ay waiver request, Z vill sot be required* to
•upply the data pursuant to Section 3(c) (2) (B) of FIFRA.
Zf the Agency denies ay vaiver request, Z must choose a
method of meeting the data requirements of this Notice
by the due date stated by this Notice. Zn this case, Z
aust, within 30 days of ay receipt of the Agency's
written decision, submit a revised "Requirements Status
and Registrant's Response" Fora indicating the option
chosen* • Z also understand that the deadline for
submission of data as specified by the original data
call-in notice vill hot change.
; +
Items 10-13. Self-explanatory.
you may provide additional information that does not fit
en this fora in a signed letter that accompanies this
fora* For example, you Bay 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 E?A can ensure that its records are
correct.
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, O.C. 204CO
JUL
PR NOTICE 86—5 PMTICIDCS ANB TOXIC UIMTANCES
•_ NOTICE TO PRODUCERSt FORMULATORS, DISTRIBUTORS
AND REGISTRANTS
Attentions Persons responsible for Federal registration off
pesticides.
Subject: Standard format for data submitted under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA)
and certain provisions of the Federal Food, Drug,
and Coc.ietic Act (FFDCA).
I. Purpose
to require data to be submitted to the Environmental
Protection Agency (EPA) in a standard format. This Notice also
provides additional guidance about, and illustrations of, the
required formats.
II. Applicability
This PR Notice applies to all data that are submitted to EPA
to satisfy data requirements for granting or maintaining pesticide
registrations, experimental use permits, tolerances, and related
approvals under certain provisions of FIFRA and FFDCA. These
data are defined in FIFRA S10(d)(l). This Notice does not apply
to commercial, financial, or production information, which are,
and roust continue to be, submitted differently under separate
cover.
III. Effective Date
This notice is effective on November 1, 1966. Data formatted
according to this notice may be submitted prior to the effective
date. As of the effective date, submitted data packages that do
not conform to these requirements may be returned to the submitter
for tnecessary revision.
IV. Background
On September 26, 1984, EPA published proposed regulations
in the Federal Register (49 FR 37956) which include Requirements
for Data Submission (40 CFR $158.32), and Procedures for Claims
of Confidentiality of Data (40 CFR $158.33). These regulations
-------
specify the format for data submitted to EPA under Section 3 of
FIFRA and Sections 408 and 409 of FFDCA, and procedures which
must be followed to make and substantiate claims of confiden-
-:ality. Ns entiti .its :> -lata c -fide^ialifcy are char^c-d,
either by the proposed regulation or by this notice.
OPP is making these requirements mandatory through this
Notice to gain resource-saving benefits from their use before the
entire proposed regulation becomes final. Adequate lead time is
being provided for submitters to comply with the new requirements.
V. Relationship of this Notice to other OPP Policy and Guidance
While this Notice contains requirements for organizing and
'formatting submittals of supporting data, it does not address
the substance of test reports themselves. "Data reporting"
guidance is now under development in OPP, and will specify how
the study objectives, protocol, observations, findings, and
conclusions are organized and presented within the study report.
The data reporting guidance will be compatible with submittal
format requirements described in this Notice.
OPP has also promulgated a policy (PR Notice 86-4 dated
April 15, 1986) that provides for early screening of certain
applications for registration under FIFRA S3. The objective of
the screen is to avoid the additional costs and prolonged delays
associated with handling significantly incomplete application
packages. As of the effective date of this Notice, the screen
will include in its criteria for acceptance of application
packages the data formatting requirements described herein.
OPP has also established a public docket which imposes dead-
line.s for inserting into the docket documents submitted in con-
nection with Special Reviews and Registration Standards (see
40 CFR 5154.15 and $155.32). To meet these deadlines, OPP is
requiring an additional copy of any data submitted to the docket.
Please refer to Page 10 for more information about this requirement,
For several years, OPP has required that each application for
registration or other action include a list of all applicable
data requirements and an indication of how each is satisfied—the
statement of the method of support for the application. Typically,
many requirements are satisfied by reference to data previously
submitted—either by the applicant or by another party. That re-
quirement is not altered by this notice, which applies only to
data submitted with an application.
VI. Format Requirements
A more detailed discussion of these format requirements
follows the index on the next page, and samples of some of the
requirements are attached. Except for the language of the two
alternative forms of the Statement of Data Confidentiality Claims
(shown in Attachment 3) which cannot be altered, these samples
are illustrative. As long as the required information is included
and clearly identifiable, the form of the samples may be altered
to reflect the submitter's preference.
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- INDEX -
A. Organization of the Submittal Package
B. Transmittal Document
C. individual Studies ......
C.I Special Considerations for Identifying Studies.
D. Organization of each study Volume
D.I Study Title Page
Text Exarple
Page Page
D.2 Statement of Data Confidentiality Claims
(based on FIFRA S10(d)(l)) ,
D.3 Confidential Attachment
3
4
4
5
6
7
8
8
17
11
17
12
13
15
D.4 Supplemental Statement of Data Confidentiality
Claims (other than those based on FIFRA $10(d)(l)J 6 14
D.5 Good Laboratory Practice Compliance statement . . 9 16
E. Reference to Previously Submitted Data . 9
F. Physical Format Requirements & Number of Copies ... 9
G. Special Requirements for Submitting Data to the Docket 10
****t*********
A. Organization of Submittal Package
A 'submittal package1 consists of all studies submitted at
the same time for review in support of a single regulatory action,
along with a transmittal document and other related administrative
material (e.g. the method of support statement, EPA Forms 8570-1,
8570-4, 8570-20, etc.) as appropriate.
Data submitters must organize each submittal package as
described in this notice. The transmittal and any other admin-
istrative material must be grouped together in the first physical
volume. Each study included in the submittal package must then
be bound separately.
S'Jbmitters sometimes provide additional materials that are
intended to clarify, emphasize, or otherwise comment to help
Product Managers and reviewers better understand the submittal.
If such materials relate to one study/ they should be
included as an appendix to that study.
- If such materials relate to more than one study (as for
example a summary of all studies in a discipline) or to the
submittal in general, they must be included in the submittal
package as a separate study (with title page and statement
of confidentiality claims).
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B. Transmittal Document
The first item in each submittal package must be a trans-
mit*?! .'--j.-* .:. Tri- ••* . "".fr": identifies the Sut-n;Ut?r or all
joint submitters; the regulatory action in support of which the
package is being submitted—i.e., a registration application,
petition, experimental use permit (EUP), S3(c)(2)(B) data call-in,
S6(a)(2) submittal, or a special review; the transmittal date;
and a list of all individual studies included in the package in
the order of their appearance, showing (usually by Guideline
reference number) the data requirements) addressed by each one.
The EPA-assigned number for the regulatory action (e.g. the
registration, EUP, or tolerance petition number) should be
included in the transmittal document as well, if it is known to
the submitter, see Attachment 1 for an example of an acceptable
transmittal document.
The list of included studies in the transmittal of a data
submittal package supporting a registration application should
be subdivided by discipline, reflecting the order in which data
requirements appear in 40 CFF 158.
The list of included studies in the transmittal of a data
submittal package supporting a petition for tolerance or an
application for an EUP should be subdivided into sections A, B,
C,.... of the petition or application, as defined in 4(f CFR
180.7 and 158.125, (petitions) or Pesticide Assessment Guidelines,
Subdivision I (EUPs) as appropriate.
When a submittal package supports a tolerance petition and
an application for a registration or an EUP, list the petition
studies first, then the balance of the studies. Within these
two groups of studies follow the instructions above.
C. Individual Studies
A study is the report of a single scientific investigation,
including all supporting analyses required for logical complete-
ness. A study should be identifiable and distinguishable by a
conventional bibliographic citation including author, date, and
title. Studies generally correspond in scope to a single Guide-
line requirement for supporting data, with some exceptions dis-
cussed in section C.I. Each study included in a submittal package
must be bound as a separate entity. (See comments on binding
studies on page 9.)
Each study must be consecutively paginated, beginning from
the title page as page 1. The total number of pages in the com-
plete study must be shown on the study title page. In addition
(to ensure that inadvertently separated pages can be reassociated
with the proper study during handling or review) use either of
the following:
- Include the total number of pages in the complete study
on each page (ie., 1 of 250, 2 of 250, ...250 of 250).
- Include a company name or mark and study number on each
page of the study, e.g.. Company Name-1986-23. Never reuse
a study number for marking the pages of subsequent studies.
-------
Mien a single study is extremely long, binding it in multiple
volumes is permissible so long as th«» entire study i* pa^inaf?-*
.;; a air.*.lfc avties, ana eacn volume is plainly identified by the
study title and its position in the multi-volume sequence.
C.I special Considerations for Identifying Studies
Some studies raise special problems in study identification,
because they address Guidelines of broader than normal scope or
for other reasons.
a. Safety studies. Several Guidelines require testing for
safety in more than one species. In these cases each species
tested should be reported as a separate study, and bound
separately.
Extensive supplemental reports of pathology reviews, feed
analyses, historical control data, and the like are often assoc-
iated with safety studies. Whenever possible these should be
submitted with primary reports of the study, and bound with the
primary study as appendices. When such supplemental reports are
submitted independently of the primary report, take care to fully
.identify the primary report to which they pertain.
Batteries of acute toxicity tests, performed on the same end
use product and covered by a single title page, may be bound
together and reported as a single study,
b. Product Chemistry Studies. All product chemistry data
within a submittal package submitted in support of an end-use
product produced from registered manufacturing-use products
should be bound as a single study under a single title page.
Product chemistry data submitted in support of a techni-
cal product, other manufacturing-use product, an experimental
use permit, an import tolerance petition, or an end-use prod-
uct produced from unregistered source ingredients, should be
bound as a single study for each Guideline series (61, 62,
and 63) for conventional pesticides, or for the equivalent
subject range for biorational pesticides. The first of the
three studies in a complete product chemistry submittal for
a biochemical pesticide would cover Guidelines 151-10, 151-11,
and 151-12; the second would cover Guidelines 151-13, 151-15,
and 151-16; the third would cover Guideline 151-17. The
first study for a microbial pesticide would covet Guidelines
151-20, 151-21, and 151-22; the second would cover Guidelines
151-23 and 151-25; the third would cover Guideline 151-26.
Note particularly that product chemistry studies are
likely to contain Confidential Business Information as defined
in FIFRA S10(d)(1)(A), (B), or (C), and if so must be handled
as described in section D.3. of this notice.
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c. Residue Chemistry Studies. Guidelines 171-4, 153-3,
and ''S'?-^ are extreme! *> broad in ^cooet stjdlies addressing
residue chemistry requirements mu&c oiuS o«a Octiriea at a
level below that of the Guideline code. The general principle,
however, of limiting a study to the report of a single inves-
tigation still applies fully. Data should be treated as a
single study and bound separately for each analytical method,
each report of the nature of the residue in a single crop or
animal species, and for each report of the magnitude of resi-
dues resulting from treatment of a single crop or from proces-
sing a single crop. When more than one commodity is derived
from a single crop (such as beet tops and beet roots) residue
data on all such commodities should be reported as a single
study. When multiple field trials are associated <*ith a
single crop, all such trials should be reported as a single
study.
D. Organization of Each Study Volume
Each complete study must include all applicable elements in
the list below, in the order indicated. (Also see Page 17.)
Several of these elements are further explained in the following
paragraphs. Entries in the column headed 'example1 cite the
page number of this notice where the element is illustrated.
Element
Study Title Page
Statement of Data
Confidentiality
Claims
Certification of Good
Laboratory Practice
Flagging statements
Body of Study
Study Appendices
Cover Sheet to Confi-
dential Attachment
t
CBI Attachment
Supplemental Statement
of Data Confidentiality
Claims
When Required Example
Always Page 12
One of the two alternative Page 13
forms of this statement
is always required. '
If study reports laboratory Page 16
work subject to GLP require-
ments
For certain toxicology studies. (When
flagging requirements are finalized.)
Always - with an English language
translation if required.
At submitter's option
If CBI is claimed under FIFRA
510(d)(l){A), (B), or (C)
If CBI is claimed under FIFRA
f filO(d)(l)(A), (B), or (C)
Only if confidentiality is
claimed on a basis other than
FIFRA S10(d)(l)(A), (B), or (C)
Page 15
Page 14
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D.I Title page
A title page is always required for each submitted study,
published or unpublished. The title page must always be freely
releasable to requestors; DO NOT INCLUDE CBI ON THE TITL3 PAGE.
An example of an acceptable title page is on page 12 of this
notice. The following information must appear on the title
paget
a. Study title. The study title should be as descriptive as
possible.It must clearly identify the substance(s) tested and
correspond to the name of the data requirement as it appears
in the Guidelines.
b. Data requirement addressed. Include on the title page the
Guideline number(s) of the specific requirement(s) addressed by
the study.
c< Author(s). Cite only individuals with primary intellectual
responsibility for the content of the study. Identify them
plainly as authors, to distinguish them from the performing
laboratory, study sponsor, or other names that nay also appear on
the title page.
d" StudyDate. The title page must include a single date for
the study. If parts of the study were performed at different
times, use only the date of the latest element in the study.
e. Performing Laboratory Identification. 'If the study reports
work done by one or more laboratories,include on the title page
the name and address of the performing laboratory or laboratories,
and the laboratory's internal project number(s) for the work.
Clearly distinguish the laboratory's project identifier from any
other reference numbers provided by the study sponsor or submitter.
f. Supplemental Submissions. If the study is a commentary on
or supplement to another previously submitted study, or if it
responds to EPA questions raised with respect to an earlier study,
include on the title page elements a. through d. for the previously
submitted study, along with the EPA Master Record Identifier (MRID)
or Accession number of the earlier study if you know these numbers.
(Supplements submitted in the same submittal package as the primary
study should be appended to and bound with the primary study. DO
not include supplements to more than one study under a single
title page).
t
g. Facts of Publication. If the study is a reprint of a pub-
lished document, identify on the title page all relevant facts
of publication, such as the journal title, volume, issue, inclusive
page numbers, and publication date.
-------
D.2. Statements of Data Confidentiality Claims under FIFRA SlO(d)U).
Each submitted study must be accompanied by one of the two
alternative forms of the Statement of Data Confidentiality Claims
specified in the proposed regulation in (5158.33 (b) and (c).
(See Attachment 3) These statements apply only to claims of data
confidentiality based on FIFRA $10(d) (1) (A77(B), or (C). Use
the appropriate alternative form of the statement either to
assert a claim of SlO(dHl) data confidentiality <$158.33(b))
or to waive such a claim (5158.33(0). Zn either case, the
statement must be signed and dated, and must include the typed
name and title of the official who signs it. Do not make CBI
claims with respect to analytical methods associated with petitions
for tolerances or emergency exemptions (see NOTE Pg 13).
D.3. Confidential Attachment
If the claim is made that a study includes confidential busi-
ness information as defined by the criteria of FIFRA S10(d)(1)(A),
(B), or (C) (as described in D. 2. above) all such information must
be excised from the body of the study and confined to a separate
study-specific Confidential Attachment. Each passage of CBI so
isolated must be identified by a reference number cited within the
-body of the study at the point from which the passage was excised
(See Attachment S).
The Confidential Attachment to a study must be identified by a
coyer sheet fully identifying the parent study, and must be clearly
marked 'Confidential Attachment.1 An appropriately annotated
photocopy of the parent study title page may be used as this cover
sheet. Paginate the Confidential Attachment separately from the
body of the study, beginning with page 1 of X on the title page.
Each passage confined to the Confidential Attachment must be assoc-
iated with a specific cross reference to the page(s) in the main
body of the study on which it is cited, and with a reference to the
applicable passage(s) of FIFRA $10(d)(l) on which the confidentiality
claim is based.
D.4. Supplemental Statement of Data Confidentiality Claims (See
Attachment 4)
If you wish to make a claim of confidentiality for any
portion of a submitted study other than described by FIFRA 510(d)
(1)(A), (B), or (C), the following provisions apply:
- The specific information to which the claim applies must be
clearly marked in the body of the study as'subject to a
claim of confidentiality.
*- A Supplemental Statement of Data Confidentiality Claims
must be submitted, identifying each passage claimed confi-
dential and describing in detail the basis for the claim.
A list of the points to address in such a statement is
included in Attachment 4 on Pg 14.
- The Supplemental Statement of Data Confidentiality Claims
must be signed and dated and must include tne typed name
and title of the official who signed it.
8
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D.5 C?cd Lat*-ratr>ry Practict* Compliance Statement
This statement is required if the study contains laboratory
work subject to GLP requirements specified in 40 CFR 160. Sam-
ples of these statements are shown in Attachment 6.
E. Reference to Previously Submitted Data
DO NOT RESUBMIT A STUDY THAT HAS PREVIOUSLY BEEN SUBMITTED
FOR ANOTHER PURPOSE unless EPA specifically requests it. A copy
of the title page plus the MRID number (if known) is sufficient
to allow us to retrieve the study immediately for review. This
prevents duplicate entries in the Agency files, and saves you
the cost of sending more copies of the study. References to pre-
viously submitted studies should not be included in the transmit-
tal document, but should be incorporated into the statement of
the method of support for the application.
F. Physical Format Requirements
All elements in the data submittal package must "be on uniform
8 1/2 by 11 inch white paper, printed on one side only in black
ink, with high contrast and good resolution. Bindings for indi-
vidual studies must be secure, but easily removable to permit
disassembly for microfilming. Check with EPA for special
instructions before submitting data in any medium other than
paper, such as film or magnetic media.
Please be particularly attentive to the following pointss
o Do not include frayed or torn pages.
o Do not include carbon copies, or copies in other than
black ink.
o Hake sure that photocopies are clear, complete, and fully
readable.
o Do not include oversize computer printouts or fold-out pages.
o Do not bind any documents with glue or binding tapes.
o Jlake sure that all pages of each study, including any attach-
ments or appendices, are present and in correct sequence.
' Number of Copies Required - All submittal*packages except
those associated with a Registration Standard or Special Review
(see Part G below) must be provided in three complete, identical
copies. (The proposed regulations specified two copies; three
are now being required to expedite and reduce the cost of proces-
sing data into the OPP Pesticide Document Management System and
getting it into review.)
-------
G.
Special Requirements for Submitting Data to the Docket
Data suDmittal packages associated witn a Registration Stan-
dard or Special Review must be provided in four copies, from one
of which all material claimed as CBI has been excised. This
fourth copy will become part of the public docket Cor the RS or
SR case. If no claims of confidentiality are made for the study,
the fourth copy should be identical to the other three, when
portions of a study submitted in support of an RS or SR are
claimed as CBI, the first three copies will include the CBI
material as provided in section D of this notice. The following
special preparation is required for the fourth copy.
o Remove the 'Supplemental Statement of Data Ccnfidentiality
Claims'.
o Remove the 'Confidential Attachment'.
o Excise from the body of the study any information you claim
as confidential, even if it does not fall within the scope
of FIFRA $10(d)(l)(A), (B), or (C). Do not close up or
paraphrase text remaining after this excision.
.o Mark the fourth copy plainly on both its cover and its title
page with the phrase "Public Docket Material * contains no
information claimed as confidential".
V. For Further information
For further information contact William C. Grosse, Chief,
Information Services Branch, Program Management and Support
Division, (703-557-2613).
ames w. Akerman
Acting Director,
Registration Division
Attachment 1.
Attachment 2.
Attachment 3.
Attachment 4.
Attachment 5.
Attachment 6.
Attachment 7.
Sample Transmittal Document
Sample Title Page for a Newly Submitted Study
Statements of Data Confidentiality Claims
Supplemental Statement of Data Confidentiality Claims
Samples of Confidential Attachments
Sample Good Laboratory Practice statements
Format Diagrams for Submittal Packages and Studies
10
-------
ATTACHMENT 1.
ELEMENTS TO BE INCLUDED IN THE TRANSMITTAL DOCUMENT*
1. Name and address of submitter
-------
ATTACHMENT 2.
SAMPLE STUDY TITLE PAGE FOR A NEWLY SUBMITTED STUDY
Study Title
(Chemical name) - Magnitude of Residue on Corn
Data Requirement
Guideline 171-4
Author
John C. Davis
Study Completed On
January 5, 1979
Performing Laboratory
ABC Agricultural Laboratories
940 West Bay Drive
Wilmington, CA 39897
Laboratory ProjectID
ABC 47-79
Page 1 of X
CX is the total number of pages in the study)
-------
r 3.
STATEMENTS OF DATA CONFIDENTIALITY CLAIMS
1. No claim of confidentiality under FIFRA S10{d)U)(A),(B), or (C)
STATEMENT OF NO DATA CONFIDENTIALITY CLAIMS
No claim of confidentiality is made for any information contained in this study
en the basis of its falling within the scope of FIFRA S10(d)(l)(A), (B), or (C).
Company
Company Agent:
Typed Name
Title
Date:
Signature
2. Claim of confidentiality under FIFRA $10(d)(l)(A), (B), or (C).
STATEMENT OF DATA CONFIDENTIALITY CLAIMS
Information claimed confidential on the basis of its falling within the scope
of FIFRA $10(d)(l)(A), (B), or (C) has been removed to a confidential appendix,
and is cited by cross-reference number in the body of the study.
Company*
Company Agent:
Typed Name
Title
Date:
Signature
NOTEs Applicants for permanent or temporary tolerances should note that it
is OPP policy that no permanent tolerance, temporary tolerance, or request for
an emergency exemption incorporating an analytical method, can be approved
unless the applicant waives all claims of confidentiality for the analytical
method. These analytical methods are published in the FDA Pesticide Analyt-
ical Methods Manual, and therefore cannot be claimed as confidential. OPP
implements this policy by returning submitted analytical methods, for which
which confidentiality claims have been maue, to the submitter, to obtain
the confidentiality waiver before they can be processed.
13
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ATTACHMENT 4.
SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
For any portion of a submitted study that is not described
by FIFRA SlO(d)UHA), (B), or (C), but for which you claim
confidential treatment on another basis, the following informa-
tion must be included within a Supplemental Statement of Data
Confidentiality Claimst
o Identify specifically by page and line number(s) each
portion of the study for which you claim confidentiality.
'o Cite the reasons why the cited passage qualifies for
confidential treatment.
o indicate the length of time—until a specific date or
event, or permanently—for which the information should
be treated as confidential.
o Identify the measures taken to guard against undesired
disclosure of this information.
o Describe the extent to which the information has been
disclosed, and what precautions have been taken in con-
nection with those disclosures.
o Enclose copies of any pertinent determinations of confi-
dentiality made by EPA, other Federal agencies, or courts
concerning this information.
p. -If you assert that disclosure of this information would
be likely to result in substantial harmful effects to
you, describe those harmful effects and explain why they
should be viewed as substantial.
o If you assert that the information is voluntarily sub-
mitted, indicate whether you believe disclosure of this
information might tend to lessen the availability to
EPA of similar information in the future, and if so, how.
14
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/CTACKfENT 5.
EXAMPLES OF SEVERAL CONFIDENTIAL ATTACHMENTS
Example 1 (Confidential word or phrase that has been deleted fron the study)
CROSS REFERENCE NUMBER 1
DELETED WORDS OR PHRASE:
This cross reference number is used in the study
in place of the following words or phrase at the
indicated volume and page references.
Ethylene Glycol
PAGE LINE REASON FOR TOE
6
28
100
14
25
19
Identity of Inert Ingredient
FIFRA REFERENCE
SlOldMlHC)
Example 2 (Confidential paragraphs) that have been deleted from the study)
CROSStfEFERENCE NUMBER 5 This cross reference number is used in the study
in place of the following paragraphs) at the
indicated volume and page references.
DELf2raHKAGRAPH(S) I
Reproduce the deleted paragraph(s) here
PAGE..LIMES REASON FOR THE DELETION FIFRA REFERENCE
20 4-17 Description of the quality control process S10(d)(l)(C)
Example 3 {Confidential pages that have been deleted from the study)
CROSS
DEL
NUMBER 7 This cross reference nunfcer noted on a place-holder
page is used in place of the following whole pages
at the indicated volume and page references.
(ST: are attached innediately behind this page.
REASON FDR THE DELETION
Description of product manufacturing process
FIFRA REFERENCE
IS
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ATTACH* F!T 6.
SAMPLE GOOD LABORATORY PRACTICE STATEMENTS
Example 1.
This study meets the requirements for 40 CFR Part 160
Submitter •
Sponsor
Study Director
Example 2,
This study does not meet the requirements of 4C CPR
Part 160, and differs in the following ways:
1.
2.
3.
Submitter
Sponsor
Study Director
Example 3.
The submitter of this study was neither the sponsor of this
study nor conducted it, and does not know whether it has
been conducted in accordance with 40 CFR Part 160.
Submitter
16
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ATTACHMENT 7.
FORMAT OP THE SUBMITTAL PACKAGE
Transmittal Document.
Related Administrative Materials
(e.g.. Method of Support Statement, etc.)
Other materials about the submittal
(e.g., summaries of groups of studies
to aid in their review).
Studies, submitted as unique
physical entities, according
to the format below.
FORMAT OF SUBMITTED STUDIES
Study title page.
Statement of Confidentiality Claims.
GLP and flagging* statements - as appropriate.
Body of the study, with English
language translation if required.
Appendices to the study.
Title Page of the Confidential
' ,.• Attachment.
-J 1 Confidential Attachment,
I '-"
_j- —1 Supplemental Statement
-* , . of Confidentiality Claims,
• »
x-*"" * when flagging requirements
->*' are finalized.
LEGEND
Documents which must be submitted as
appropriate to meet established requirements.
I
Documents submitted at submitter's option.
17
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ATTACHMENT D
EPA GROUPING OF END-USE PRODUCTS FOR MEETING
DATA REQUIREMENTS FOR REREGISTRATION
-------
EF&'S f*»?rgTi^l NOT TO BKRH HBMEE HPOULT5 OCMMNIN3 UL'iKiC JIOD FOR MJKHJSES
OF MUEEINS Acuus TGKICTIY DKBk BEQDIBEMEtnS FCR REKECESTRATIQN
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 citric acid, 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
PL a
prpCTMt- J"TU>TY labeling, etc. )
However, batching of end-use products containing citric acid was not
possible after considering the available information described above. Table I
lists all the end-use products containing citric acid. These products were
either considered not to be similar for purposes of acute toxicity or the Agency
lacked sufficient information for decision making purposes. Registrants of these
products are responsible for meeting the acute toxicity data requirements for
each product.
Registrants must gen
each of their products.
te all the required acute toxicological studies for
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 (sea acceptance criteria attached) .
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 OCX Notice contains two response forms which are to be
completed and submitted to the Agency within 90 days of receipt. The first form,
"Data Call-in Response," asks whether the registrant will meet the data
requirements for each product. The second form, "Requirements Status and
Registrant's Response," lists the product specific data required for each
product, including the standard six acute toxicity tests. A registrant 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 citric acid
could not be batched, registrants cannot choose from the remaining options: Cost
sharing (Option 2) or Offers to Cost Share (Option 3) .
-------
Table Z. Bid-Use Products Containing Citric Acid
EPA REG. NO.
1*77-90
1677-100
5664-4
X of Cftrfc Acid ft Other Active Ingredients
20.0X - Citric Acid
22.SX - Phosphoric Acid
2.0X - Decvnic Acid
6.0X - Octenolc Acid
4.6X - Citric Acid
16.4X - Phosphoric Acid
1.0X - Citric Acid
B.SX - Phosphoric Acid
5.0X • Sulfssric Acid
3.0X - Oxolie Acid
1 .OX • Bluconf c Acid
1 .2X - Sodlui Xyleno sulphonste
ForiMletion Type
Liquid
liquid
Liquid
-------
ATTACHMENT E
EPA ACCEPTANCE CRITERIA
-------
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
-------
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 <0.1%
4. Purpose of each active ingredient and each intentionally-
added inert
5. Chemical name from Chemical Abstracts index of Nomenclature
and Chemical Abstracts Service (CAS) Registry Number for each
active ingredient and, if available, for each intentionally-
added inert
6. Molecular, structural, and empirical formulas, molecular
weight or weight range, and any company assigned experimental
or internal code numbers for each active ingredient
7. Description of each beginning material in the manufacturing
process
EPA Registration Number if registered; for other
beginning materials, the following:
Name and address of manufacturer or supplier
Brand name, trade name or commercial designation
Technical specifications or data sheets by which
manufacturer or supplier describes composition,
properties or toxicity
8. Description of manufacturing process
Statement of whether batch or continuous process
Relative amounts of beginning materials and order in
which they are added
, Description of equipment
Description of physical conditions (temperature,
pressure, humidity) controlled in each step and the
parameters that are maintained
Statement of whether process involves intended chemical
reactions
-------
8. (continued)
9.
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)
-------
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.
-------
62 Analysis and Certification of Product Ingredients
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active
ingredient being reregistered. Use a table to present the
information in items 6, 7, and 8.
Does your study meet the following acceptance criteria?
1. Five or more representative samples (batches in case of
batch process) analyzed for each active ingredient and all
impurities present at > 0.1%
2. Degree of accountability or closure > ca 98%
3. Analyses conducted for certain trace toxic impurities at
lower than 0.1% (examples, nitrosamines in the case of
products containing dinitroanilines or containing secondary
or tertiary amines/alkanolamines plus nitrites;
polyhalogenated dibenzodioxins and dibenzofurans) [Note
that in the case of nitrosamines both fresh and stored
samples must be analyzed.]
4. Complete and detailed description of each step in analytical
method used to analyze above samples
5. statement of precision and accuracy of analytical method
used to analyze above samples
6. Identities and quantities (including mean and standard
deviation) provided for each analyzed ingredient
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._J Analytical methods (as discussed in 19) to verify certified
limits validated as to their precision and accuracy
-------
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).
-------
63 Physical and Chemical Characteristics
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active
ingredient being reregistered.
Does your study meet the following acceptance criteria?
63-2 Color
Verbal description of coloration (or lack of it)
Any intentional coloration also reported in terms of
Munsell color system
63-3 Physical State
Verbal description of physical state provided using terms
such as "solid, granular, volatile liquid"
Based on visual inspection at about 20-25* C
63-4 Odor
Verbal description of odor (or lack of it) using terms
such as "garlic-like, characteristic of aromatic
compounds"
Observed at room temperature
63-5 Melting Point
Reported in C*
Any observed decomposition reported
63-6 Boiling Point
Reported in C*
Pressure under which B.P. measured reported
Any observed decomposition reported
63-7 Density, Bulk Density, Specific Gravity
Measured at about 20-25' C
Density of technical grade active ingredient reported in
» g/ml or the specific gravity of liquids reported with
reference to water at 20* C. [Note: Bulk density of
registered products may be reported in Ibs/ft or
Ibs/gallon.]
-------
63-8 Solubility
Determined in distilled water and representative polar and
non-polar solvents, including those used in formulations
and analytical methods for the pesticide
Measured at about 20-25' C
Reported in g/100 ml (other units like ppm acceptable if
sparingly soluble)
63-9 Vapor Pressure
Measured at 25* C (or calculated by extrapolation from
measurements made at higher temperature if pressure too
low to measure at 25* C)
Experimental procedure described
Reported in mm Hg (torr) or other conventional units
63-10 Dissociation Constant
Experimental method described
Temperature of measurement specified (preferably
about 20 - 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
-------
63 Physical and Chemical Characteristics
GUIDANCE FOR SUMMARIZING STUDIES
The following criteria apply to the technical grade of the active
ingredient being reregistered.
Description of color.
Description of physical state.
Description of odor.
Indication of melting point (in C').
Indication of boiling point (in C*).
Indication of density, bulk density,
Indication of solubility.
Indication of vapor pressure.
Indication of dissociation constant.
Indication of octanol/water partition coefficient.
Indication of PH.
and specific gravity.
-------
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
-------
81-1 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. I
9. Individual body weights. •
10. Gross necropsy on all animals.
Criteria marked with a * are supplemental and may not be required
for every study.
-------
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
-------
81-2 Acute Dermal toxicity in the Rat, Rabbit or Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc)
2. At least 5 animals/sex/group
3.* Rats 200-300 gm, rabbits 2.0-3.0 kg or guinea pigs 350-
450 gm.
4. Dosing, single dermal.
5. Dosing duration at least 24 hours.
6.*^ Vehicle control, only if toxicity of vehicle is unknown.
7. Doses tested, sufficient to determine a toxicity category
or a limit dose (2000 mg/kg).
8. Application site clipped or shaved at least 24 hours
before dosing
9. Application site at least 10% of body surface area.
10. Application site covered with a porous nonirritating cover
to retain test material and to prevent ingestion.
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
Criteria marked with a * are supplemental and may not be required
for every study.
-------
81-2 Acute Dermal Toxicity in the Rat, Rabbit 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
-------
81-3 Acute Inhalation Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1,
2.
3,
4,
5,
6,
7,
8,
9,
10,
11,
12.
13.
14.
Identify material tested (technical, end-use product, etc)
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).
At least 5 young adult rats/sex/group
Dosing, at least 4 hours by inhalation.
Chamber air flow dynamic, at least 10 air changes/hour, at
least 19% oxygen content.
Chamber temperature, 22* C (±2), relative humidity 40-60%.
Monitor rate of air flow
Monitor actual concentrations of test material in breathing
zone.
Monitor aerodynamic particle size for aerosols.
Doses tested, sufficient to determine a toxicity category
or a limit dose (5 mg/L actual concentration of respirable
substance).
Individual observations at least once a day.
Observation period to last at least 14 days.
Individual body weights.
Gross necropsy on all animals.
-------
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?
1. Identify material tested (technical, end-use product, etc)
2. Study not required if material is corrosive, causes severe
dermal irritation or has a pH of < 2 or > 11.5.
3. 6 adult rabbits
4. Dosing, instillation into the conjunctival sac of one eye
per animal.
5. Dose, 0.1 ml if a liquid; 0.1 ml or not more than 100 mg if
a solid, paste or particulate substance.
6. Solid or granular test material ground to a fine dust.
7. Eyes not washed for at least 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.
-------
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
-------
81-5 Primary Dermal Irritation Study
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc)
2. Study not required if material is corrosive or has a
pH of <2 or > 11.5.
3. 6 adult animals.
4. Dosing, single dermal.
5. Dosing duration 4 hours.
6. Application site shaved or clipped at least 24 hours prior
to dosing
7. Application site approximately 6 cm.
8. Application site covered with a gauze patch held in place
with nonirritating tape
9. Material removed, washed with water, without trauma to
application site
10. Application site examined and graded for irritation at 1,
24, 48 and 72 hr, then daily until normal or 14 days
(whichever is shorter).
11,.* Individual daily observations.
Criteria marked with a * are supplemental and may not be required
for every study.
-------
81-5 Primary Dermal Irritation Study
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, 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.
-------
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
Hauer 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
-------
ATTACHMENT F
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
-------
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ATTACHMENT G
COST SHARE AND DATA COMPENSATION FORMS
-------
r/EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
Form Approved
OMB No. 2070-0106
Approval Eiplra* 12-31-12
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
tint* tor 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
as|wct of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Bninch, PM-223, U.S. Environmental Protection Agency, 401 M St.. S.W., Washington, DC 20460; and to the Office
of Management and Budget. Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Pitas* fill In blanks below.
Company Nama
Product Name
EPA Reg. No.
ICeitifythat:
1. For each study cited in support of registration or reregistratton under the Federal Insecticide, Fungicide and
Hodentfcide Act {FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the
written permission of the original data submitter to cite that study.
That for each study dted in support of registration or reregistratton under FIFRA that is NOT an exclusive use
study, I am the original data submitter, or I have obtained the written permission of the original data submitter, or I
have notified in writing the company(ies) that submitted data I have cited and have offered to: (a) Pay
compensation for those data in accordance with sections 3{c)(i)(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, V any. The companies I have notified are:
[ I The companies who have submitted the studies listed on the back of this form or attached
sheets, or indicated on the attached "Requirements Status and Registrants' Response Form,'
3. That I have previously complied with section 3(C)(1 )(D) of FIFRA for the studies I have tiled in support of
registration or reregistratton under FIFRA.
Signature
Data
Nanrn and Tltla (Pitas* Typo or Print)
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the
registration or reregistratton of my products, to the extent required by FIFRA sections 3(C)(1)(D) and 3(C)(2)(D),
!signilur*
Data
Nam* and T)Ua
-------
&EPA
Unlttd States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OUB No. 20704106
Approval Expirea 12-3V92
Pubic reporting burden for this collection of Information is estimated to average 15 minutes per response, including
time tor reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief, information Policy
Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W.. Washington, DC 20460; and to the Office
of Management and Budget. Paperwork Reduction Project (20704106), Washington. DC 20503.
Please fill In blanks below.
Company Namo
Product Name
EPA Reg. No.
I Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However, my company would prefer to
e.iter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data.
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA If final agreement on all
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
Nraii of Flrm(a)
Date of Offer
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature
Namo and
of Company'* Authorized Representative
Title (Please Type or
Date
Print)
EPA Form 1570-32
-------
US Environmental Protection Agency Registration Standard for:
Washington. DC 80400
SERA Product Specific
**u j-% Data Re£ort
Registration
Guideline No.
Sfcc. I5ai20
Product
Chemistry
61-1
81-2 fa)
ei-2 fb)
82-1
62-2
62-3
63-2
0-3
63-»
63-9
6M
63-7
63-8
63-9
63-10
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-16
63-19
63-20
63-21
Sec. 158.135
Toxicology
«1.1
81-2
•1-3
81-«
61-5
814
Name of Test
Identity of Ingredients
Statement of composition
Discussion of formation of ingredients
Preliminary analysis
Certification of limit*
Analytical methods for enforcement limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-density, or specific gravity
Solubility
Vapor pressure
Dissociation constant
Octanol/water partition coefficient
PH
Stability
Oxidizing/reducing reaction
Flammability
Explodability
Storage stability
Viscosity
Mrscibility
Corrosion Characteristics
Dielectric breakdown voltage
Acute oral toxicity, rat
Acute dermal towctty. rabbit /rat /g .pig
Acute inhalation toxicity. rat
Primary eye irritation, rabbit
Primary dermal Irritation
Dermal sensitization
Testing not
required for my
product listed
above
rCn*c*D«bw)
•
m
EPA Registration Number
1 am complying with
Data Requirements by -
Citing MR 10 No.
Submitting Data
(fttacneoV
fCnec/toetow)
OMB 4207040S?
Expires 1 1-30-89
(For EPA Use
Only)
Accession
ftifpftLxtni
assigned
*
Certification
I certify that the statements i have made on this form and all attachments thereto 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.
[Typec! Name and Title
Signature
Date
EPA Fxm 8580-4 (Rev. $48) Previous edition is obsolete.
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