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-------
-------
APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
33
-------
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case Bromine covered by this Reregistration Eligibility Decision
Document. It contains generic data requirements that apply to Bromine in all products,
including data requirements for which a "typical formulation" is the test substance.
The data table is organized in the following format;
1. Data Requirement (Column 1), The data requirements are listed in the order in
which they appear in 40 CFR Part 158. the reference numbers accompanying each test refer
to the test protocols set in the Pesticide Assessment Guidelines, which are available from the
National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703)
487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the
data requirements apply. The following letter designations are used for the given use
patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files,
this column lists the identifying number of each study. This normally is the Master Record
Identification (MRID) number, but may be a "GS" number if no MRID number has been
assigned. Refer to the Bibliography appendix for a complete citation of the study.
36
-------
36
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APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Bromine
REQUIREMENT
PRODUCT CHEMISTRY
61-2A Start. Mat. & Mnfg. Process
61-2B Formation of Impurities
62-1 Preliminary Analysis
63-2 Color
63-3 Physical State
63-4 Odor
63-5 Melting Point
63-6 Boiling Point
63-7 Density
63-8 Solubility
63-9 Vapor Pressure
63-10 Dissociation Constant
63-11 Octanol/Water Partition
63-12 pH
63-13 Stability
ECOLOGICAL EFFECTS
USE PATTERN
AH
All
All
All
All
All
All
All
All
All
All
All
All
All
All
CITATION(S)
40708401, 41293601
40708401
40708402, 41293602
40708403,
40708403, 41293603
40708403,
40708403 s 41293603
40708403,
40708403, 41293603
40708403,
40708403, 41293603
40708403, 41293603
40708403, 41293603
40708403,
40708403,
All ecotoxicity requirements were waived
TOXICOLOGY
AH toxicology data requirements were waived.
-------
Data Supporting Guideline Requirements for the Registration of Bromine
REQUIREMENT USE PATTERN CITATION(S)
ErmRONMENTAL FATE
All environmental fate data requirements were waived.
RESIDUE CHEMISTRY
171-4F Magnitude of Residues - Potable L Data Gap
H20
3B
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-------
40
-------
APPENDIX C. Citations Considered to be Part of the
Data Base Supporting the Reregistration of Bromine
41
-------
42
-------
GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all
studies considered relevant by EPA in arriving at the positions and conclusions stated
elsewhere in the Reregistration Eligibility Document, Primary sources for studies in
this bibliography have been the body of data submitted to EPA and its predecessor
agencies in support of past regulatory decisions. Selections from other sources
including the published literature, in those instances where they have been considered,
are included.
2. UNITS OF ENTRY. Hie unit of entry in this bibliography is called a "study". In
the case of published materials, this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency has sought to identify
documents at a level parallel to the published article from within the typically larger
volumes in which they were submitted. The resulting "studies" generally have a
distinct title (or at least a single subject), can stand alone for purposes of review and
can be described with a conventional bibliographic citation. The Agency has also
attempted to unite basic documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID number". This number is unique
to the citation, and should be used whenever a specific reference is required. It is not
related to the six-digit "Accession Number" which has been used to identify volumes
of submitted studies (see paragraph 4(d)(4) below for further explanation). In a few
cases, entries added to the bibliography late in the review may be preceded by a nine
character temporary identifier. These entries are listed after all MRID entries. This
temporary identifying number is also to be used whenever specific reference is
needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a Author, Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the
Agency has shown an identifiable laboratory or testing facility as the author.
When no author or laboratory could be identified, the Agency has shown the
first submitter as the author.
b. Document date. The date of the study is taken directly from the document.
When the date is followed by a question mark, the bibliographer has deduced
-------
the date from the evidence contained in the-document. When the date appears
as (19??), the Agency was unable to determine or estimate the date of the
document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to
create or enhance a document title. Any such editorial insertions are contained
between square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the
trailing parentheses include (in addition to any self-explanatory text) the
following elements describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the
word "under" is the registration number, experimental use permit
number, petition number, or other administrative number associated
with the earliest known submission.
(3) Submitter. The third element is the submitter. When authorship is
defaulted to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume
in which the original submission of the study appears. The six-digit
accession number follows the symbol "CDL," which stands for
"Company Data Library." This accession number is in turn followed
by an alphabetic suffix which shows the relative position of the study
within the volume.
44
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BIBLIOGRAPHY
MRID
CITATION
40708401 Handy, R. (1988) Product Chemistry Data: Product Identity and Composition:
Bromine: RFH-88-156-2. Unpublished study prepared by Great Lakes
Chemical Corp. 9 p.
40708402 Handy, R. (1988) Product Chemistry Data (Analysis and Certification of
Product Ingredients): Bromine: RFH-156-3, Unpublished study prepared by
Great Lakes Chemical Corp. 27 p.
40708403 Handy, R. (1988) Product Chemistry Data: Physical and Chemical
Charateristics: Bromine; RFH-88-156-4. Unpublished study prepared by Great
Lakes Chemical Corp, 6 p.
41293601 Handy, R. (1989) Bromine Product Chemistry Data: Product Identity and
Composition, Unpublished study prepared by Great Lakes Chemical Corp. 9
P-
41293602 Handy, R. (1989) Bromine Product Chemistry Data: Analysis and Certification
of Product Ingredients: Lab Project Number: QCS/84/35 : QCS/79/01 :
QCS/79/02. Unpublished study prepared by Great Lakes Chemical Corp, 27
P-
41293603 Handy, R. (1989) Bromine Product Chemistry Data: Physical and Chemical
Characteristics. Unpublished study prepared by Great Lakes Chemical Corp.
6 p.
References cited in this document:
(1) Clayton, G. D., and Clayton, F. E,, eds., 1982. Patty's Industrial Hygiene and
Toxicology. 3rd Revised Ed. Wiley Interscience, NY.
(2) EPA, Office of Drinking Water, Office of Science and Technology, Health and
Ecological Criteria Division, "Rough Final draft for the Drinking
Water Criteria Document on Bromate" EPA Contract 68-C2-0139-
clement International Corporation.
(3) Harned, Hamilton, and Cole, 1944. J. Pharm. and Ther. 82:215-226.
45
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BIBLIOGRAPHY
MRID CITATION
(4) Flinn, 1941. J. Lab, and Clin. Med. 26:1325-1329.
(5) Kurokawa, Y. et al., 1986a J. Natl. Cancer Inst, 77:977-982.
(6) Kurokawa, Y. et al., 1986b Environ. Health Perspec. 69:221-236.
(7) Kurokawa, Y. et al., 1987 Jpn. J. Cancer Res. 78:358-364.
'" (8) Levine. 1983. Pharmacology: Drug Actions and Reactions. 3rd ed. pp. 240-241,
(9) Millikan, 1945. J. Iowa State Med Soc. 35:120-125.
(10) Millikan, 1946. J. Iowa State Med Soc. 36:39-48.
(12) Rosenblum, Stein, and Eisinger, 1960. Arch. Envrn. Health 1:316-323.
(13) Sax, N. I., and Lewis, R. J. Sr, 1989. Dangerous Properties of Industrial Materials. 7th
Ed. Van Nostrand Reinhold, New York.
(14) Spencer, et al., 1944. Food Research 9:11-18.
(15) Van Logten, et al., 1974. Toxicology 2:257-267.
46
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APPENDIX D. List of Available Related Documents
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-------
The following is a list of available documents related to bromine. It's purpose is to
provide a path to more detailed information if it is needed. These accompanying documents
are part of the Administrative Record for bromine and are included in the EPA's Office of
Pesticide Programs Public Docket.
1. Health and Environmental Effects Science Chapters
2. Detailed Label Usage Information System (LUIS) Report
3. Bromine RED Fact Sheet
4. PR Notice 86-5 (included in this appendix)
5. PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient
Statement
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50
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APPENDIX E. PR Notices 86-5 and 91-2
51
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52
-------
PR Notice 86-5
53
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
July 29, 1986
Of FEE DF
PR NOTICE 86-5 PREVENTION, PESTICIDES
AMD TOXIC SUBSTANCES
NOTICE TO PRODUCERS, FORMULATORS, DISTRIBUTORS
AND REGISTRANTS
Attention: Persons responsible for Federal registration of
pesticides.
Subject: Standard format for data submitted under the
Federal Insecticide, Fungicide, and Rodenticide
Act {FIFRA) and certain provisions of the Federal
Food, Drug, and Cosmetic Act {FFDCA).
I. Purpose
To require data to be submitted to the Environmental
Protection Agency (EPA) in a standard format. This Notice also
provides additional guidance about, and illustrations of, the
required formats.
II. Applicability
This PR Notice applies to all data that are submitted to EPA
to satisfy data requirements for granting or maintaining
pesticide registrations, experimental use permits, tolerances,
and related approvals under certain provisions of FIFRA and
FFDCA. These data are defined in FIFRA §10(d)(1). This Notice
does not apply to commercial, financial, or production
information, which are, and must continue to be, submitted
differently under separate cover.
III. Effective Date
This notice is effective on November 1, 1986. Data formatted
according to this notice may be submitted prior to the effective
date. As of the effective date, submitted data packages that do
not conform to these requirements may be returned to the
submitter for necessary revision.
IV. Background
On September 26, 1984, EPA published proposed regulations in
the Federal Register (49 FR 37956) which include Requirements for
Data Submission (40 CFR §158.32), and Procedures for Claims of
Confidentiality of Data {40 CFR §158.33). These regulations
55
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specify the format for data submitted to EPA under Section 3 of
FIFRA and Sections 408 and 409 of FFDCA, and procedures which
must be followed to make and substantiate claims of confiden-
tiality. No entitlements to data confidentiality are changed,
either by the proposed regulation or by this notice.
OPP is making these retirements mandatory through this
Notice to gain resource-saving benefits from their use before the
entire proposed regulation becomes final. Adequate 1'ead 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 §3. The objective of
the screen is to avoid the additional costs and prolonged delays
associated with handling significantly incomplete application
packages. As of the effective date of this Notice, the screen
will include in its criteria for acceptance of application
packages the data formatting requirements described herein.
OPP has also established a public docket which imposes
deadlines for inserting into the docket documents submitted in
connection with Special Reviews and Registration Standards (see
40 CFR §154.15 and §155.32}. To meet these deadlines, OPP is
requiring an additional copy of any data submitted to the docket.
Please refer to Page 10 for more information about this
requirement.
For several years, OPP has required that each application
for registration or other action include a list of all applicable
data requirements and an indication of how each is satisfied--the
statement of the method of support for the application.
Typically, many requirements are satisfied by reference to data
previously submitted--either by the applicant or by another
party. That requirement is not altered by this notice, which
applies only to data submitted with an application.
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.
56
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- INDEX-
Text Example
Page Page
A. Organization of the Submittal Package 3 17
B. Transmittal Document 4 11
C. Individual Studies , , -• 4
C. 1 Special Considerations for identifying Studies . , 5
D. Organization of each Study Volume 6 17
D. i . Study Title Page 7 12
D. 2 Statement of Data Confidentiality Claims
(based on FIFRA §10{d){l>} 8 13
D. 3 Confidential Attachment , 8 15
D. 4 Supplemental Statement of Data Confidentiality
Claims {other than those based on FIFRA 110(d)(D) 8 14
D. 5 Good Laboratory Practice Compliance Statement . . 9 16
E. Reference to Previously Submitted Data 9
F. Physical Format Requirements & Number of Copies .... 9
G. Special Requirements for Submitting Data to the Docket 10
**************
A. Organization of Submittal Package
A "submittal package" consists of all studies submitted at
the same time for review in support of a single regulatory
action, along with a transmittal document and other related
administrative material (e.g. the method of support statement,
EPA Forms 8570-1, 8570-4, 8570-20, etc,} as appropriate.
Data submitters must organize each submittal package as
described in this Notice. The transmittal and any other admin-
istrative material must be grouped together in the first physical
volume. Each study included in the submittal package must then
be bound separately.
Submitters sometimes provide additional materials that are
intended to clarify, emphasize, or otherwise continent to help
Product Managers and reviewers better understand the submittal,
If such materials relate to gne 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},
57
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B. Transmittal Document
The first item in each submittal package must be a trans-
mittal document. This document identifies the submitter or all
joint submitters,- the regulatory action in support of which the
package is being submitted--i.e., a registration application,
petition, experimental use permit (EUP), §3{c}(2}(B) data
call-in, §6(a)(2) submittal, or a special review; the transmittal
date; and a list of all individual studies included in the
package in the order of their appearance, showing (usually by
Guideline reference number) the data requirement(s) addressed by
each one. The EPA-assigned number for the regulatory action
{e.g. the registration, EUP, or tolerance petition number) should
be included in the transmittal document as well, if it is known
to the submitter. See Attachment 1 for an example of an
acceptable transmittal document.
The list of included studies in the transmittal of a data
submittal package supporting a registration application should be
subdivided by discipline, reflecting the order in which data
requirements appear in 40 CFR 158.
The list of included studies in the transmittal of a data
submittal package supporting a petition for tolerance or an
application for an EUP should be subdivided into sections A, B,
C, . . . . of the petition or application, as defined in 40 CFR 180.7
and 158.125, (petitions) or Pesticide Assessment Guidelines,
Subdivision I (EUPs) as appropriate.
When a submittal package supports a tolerance petition and
an application for a registration or an EUP, list the petition
studies first, then the balance of the studies. Within these two
groups of studies follow the instructions above.
C. Individual Studies
A study is the report of a single scientific investigation,
including all supporting analyses required for logical complete-
ness. A study should be identifiable and distinguishable by a
conventional bibliographic citation including author, date, and
title. Studies generally correspond in scope to a single Guide-
line requirement for supporting data, with some exceptions dis-
cussed in section C.I. Each study included in a submittal
package must be bound as a separate entity, (See comments on
binding studies on page 9.)
Each study must be consecutively paginated, beginning from
the title page as page 1. The total number of pages in the com-
plete study must be shown on the study title page. In addition
(to ensure that inadvertently separated pages can be reassociated
with the proper study during handling or review) use either of
the following:
- Include the total number of pages in the complete study on
each page (i.e., 1 of 250, 2 of 250, ...250 of 250).
- Include a company name or mark and study number on each
page of the study, e g , Company Name-1986-23. Never reuse
a study number for marking the pages of subsequent studies.
58
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When a single study is extremely long, binding it in mul-
tiple volumes is permissible so long as the entire study is pag-
inated in a single series, and each volume is plainly identified
by the study title and its position in the multi-volume sequence.
C. 1 Special Considerations for ..Identifying studies
Some studies raise special problems in study identification,
because they address Guidelines of broader than normal scope or
for other reasons.
a. Safety Studies. Several Guidelines require testing for
safety in more than one species. In these cases each species
tested should be. reported as a separate study, and bound
separately.
Extensive supplemental reports of pathology reviews, feed
analyses, historical control data, and the Tike 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. ProductChemistrv Studies. All product chemistry data
within a submittal package submitted in support of an end-use
product produced from registered manufacturing-use products
should be bound as a single study under a single title page.
Product chemistry data submitted in support of a technical
product, other manufacturing-use product, an experimental use
permit, an import tolerance petition, or an end-use product
produced from unregistered source ingredients, should be bound as
a single study for each Guideline series (61, 62, and 63) for
conventional pesticides, or for the equivalent subject range for
biorational pesticides. The first of the three studies in a
complete product chemistry submittal for a biochemical pesticide
would cover Guidelines 151-10, 151-11, and 151-12; the second
would cover Guidelines 151-13, 151-15, and 151-16; the third
would cover Guideline 151-17. The first study for a microbial
pesticide would cover Guidelines 151-20, 151-21, and 151-22; the
second would cover Guidelines 151-23 and 151-25; the third would
cover Guideline 151-26.
Note particularly that product chemistry studies are likely
to contain Confidential Business Information as defined in FIFRA
§10(d)(1)(A), (B), or (C), and if so must be handled as described
in section D.3. of this notice.
59
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c. gesidue Chemistry Studies. Guidelines 171-4, 153-3,
and 153-4 are extremely broad in scope; studies addressing
residue chemistry requirements must thus be defined at a level
below that of the Guideline code. The general principle,
however, of limiting a study to the report of a single inves-
tigation still applies fully. Data should be treated as a single
study and bound separately for each analytical method, each
report of the nature of the residue in a single crop or animal
species, and for each report of the magnitude of residues
resulting from treatment of a single crop or from processing a
single crop. When more than one commodity is derived from a
single crop {such as beet tops and beet roots) residue data on
all such commodities should be reported as a single study. When
multiple field trials are associated with a single crop, all such
trials should be reported as a single study.
D.
Organization of Each Study Volume
Each complete study must include all applicable elements in
the list below, in the order indicated. (Also see Page 17.)
Several of these elements are further explained in the following
paragraphs. Entries in the column headed "example" cite the
page number of this notice where the element is illustrated.
Element
Study Title Page
Statement of Data
Confidentiality
Claims
Certification of Good
Laboratory Practice
Flagging statements
Body of Study
Study Appendices
Cover Sheet to Confi-
dential Attachment
When Required Example
Always. Page.12
One of the two alternative Page 13
forms of this statement
is always required
If study reports laboratory Page 16
work subject to GLP require-
ments
For certain toxicology studies (When
flagging requirements are finalized,)
Always - with an English language
translation if required.
At submitter's option
If CBI is claimed under FIFRA
§10(d)(l){A}, (B), or (C)
CBI Attachment
Supplemental Statement
of Data Confidentiality
Claims
If CBI is claimed under FIFRA
§10(d)(1)(A), (B), or (C) Page 15
Only if confidentiality is Page 14
claimed on a basis other than
FIFRA §10(d)(1)(A),
-------
D.I. Title Page
A title page is always required for each submitted study,
published or unpublished. The title page must always be freely
releasable to requestors; DO NOT INCLUDE CBI ON THE TITLE PAGE.
An example of an acceptable title page is on page 12 of this
notice. The following information must appear on the title page:
a. Study title. The study title should be as descriptive as
possible It must clearly identify the substance(s) tested and
correspond to the name of the data requirement as it appears in
the Guidelines.
b. Data requirement addressed. Include on the title page the
Guideline number(s) of the specific requirement(s) addressed by
the study. , •
c. Author(s). Cite only individuals with primary intellectual
responsibility for the content of the study. Identify them
plainly as authors, to distinguish them from the performing
laboratory, study sponsor, or other names that may also appear on
the title page.
d. Study Date. The title page must include a single date for
the study. If parts of the study were performed at different
times, use only the date of the latest element in the study.
e. Performing Laboratory Identification. If the study reports
work done by one or more laboratories, include on the title page
the name and address of the performing laboratory or
laboratories, and the laboratory's internal project number(s) for
the work. Clearly distinguish the laboratory's project
identifier from any other reference numbers provided by the study
sponsor or submitter.
f. Supp1ementa1 Submi s s i ons. 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).
5- Fac t s of JPublicat ion. If the study is a reprint of a pub-
lished document, identity on the title page all relevant facts of
publication, such as the journal title, volume, issue, inclusive
page numbers, and publication date.
61
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D.2. Statements of Data Confidentiality Claims Under FIFRA
§10(d) (1) .
Each submitted study must be accompanied by one of the two
alternative forms of the statement of Data Confidentiality Claims
specified in the proposed regulation in §158.33 {b) and (c) (See
Attachment 3}. These statements apply only to claims of data
confidentiality .based on FIFRA §10(d) (1) (A) , (B), or (C) . Use
the appropriate alternative form of the statement either to
assert a claim of §lO{d){i) data confidentiality (§158,33(b)5 or
to waive such a claim {§158.33{c)). In either case, the
statement must be signed and dated, and must include the typed
name and title of the official who signs it. Do not make CBI
claims with respect to analytical methods associated with pet-
itions for tolerances or emergency exemptions (see NOTE Pg 13).
D. 3. Confidential Attachment
If the claim is made that a study includes confidential
business information as defined by the criteria of FIFRA
§10{D)(!)(A), (B), or (C) (as described inD.2. above) all such
information must be excised from the body of the study and
confined to a separate study-specific Confidential Attachment.
Each passage of CBI so isolated must be identified by a reference
number cited within the body of the study at the point from which
the passage was excised {See Attachment 5).
The Confidential Attachment to a study must be identified by
a cover sheet fully identifying the parent study, and must be
clearly marked "Confidential Attachment." An appropriately
annotated photocopy of the parent study title page may be used as
this cover sheet. Paginate the Confidential Attachment
separately from the body of the study, beginning with page 1 of X
on the title page. Each passage confined to the Confidential
Attachment must be associated with a specific cross reference to
the page(s) in the main body of the study on which it is cited,
and with a reference to the applicable passage(s) of FIFRA
§10(d)(1) on which the confidentiality claim is based.
D.4. Supplemental Statement of Data Confidentiality Claims {See
Attachment 4)
If you wish to make a claim of confidentiality for any
portion of a submitted study other than described by FIFRA §10(d)
(1)(A), (B), or (C), the following provisions apply:
- The specific information to which the claim applies must
be clearly marked in the body of the study as subject to a
claim of confidentiality.
- A Supplemental Statement of Data Confidentiality Claims
must be submitted, identifying each passage claimed confi-
dential and describing in detail the basis for the claim.
A list of the points to address in such a statement is
included in Attachment 4 on Pg 14.
- The Supplemental Statement of Data Confidentiality Claims
must be signed and dated and must include the typed name and
title of the official who signed it.
62
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D.5. Good Laboratory Practice Compliance Statement
This statement is required if the study contains laboratory
work subject to GLP requirements specified in 40 CFR 160. Sam-
ples of these statements are shown in Attachment 6,
E. Reference to Previously Submitted Data
DO NOT RESTJEMIT 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. Phys_i_cal Format Requirements
All elements in the data submittal package must be on
uniform 8 1/2 by 11 inch white paper, printed on one side only in
black, ink, with high contrast and good 'resolution. Bindings for
individual studies must be secure, but easily removable to permit
disassembly for microfilming. Check with EPA for special
instructions before submitting data in any medium other than
paper, such as film or magnetic media.
Please be particularly attentive to the following points:
• Do not include frayed or torn pages.
• Do not include carbon copies, or copies in other than
black ink.
• Make sure that photocopies are clear, complete, and
fully readable.
• Do not include oversize computer printouts or fold-out
pages.
• Do not bind any documents with glue or binding tapes.
• Make sure that all pages of each study, including any
attachments or appendices, are present and in correct
sequence.
Number of Copies Required - All submittal packages except
those associated with a Registration Standard or Special Review
(See Part G below) must be provided In three complete, identical
copies. (The proposed regulations specified two copies; three
are now being required to expedite and reduce the cost of
processing data into the OPP Pesticide Document Management System
and getting it into review.)
63
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G. SpeciaJLRequirements for Submitting Data to the,Docket
Data submittal packages associated with a Registration Stan-
dard or Special Review must be provided in four copies, from one
of which all material claimed as CBI has been excised. This
fourth copy will become part of the public docket for the RS or
SR case. If no claims of confidentiality are made for the study,
the fourth copy should be identical to the other three. When
portions of a study submitted in support of an RS or SR are
claimed as CBI, the first three copies will include the CBI
material as provided in section D of this notice. The following
special preparation is required for the fourth copy.
• Remove the "Supplemental Statement of Data
Confidentiality Claims".
• Remove the "Confidential Attachment",
• Excise from the body of the study any information you
claim as confidential, even if it does not fall within
the scope of FIFRA §10(d)(1)(A), (B) , or {C). Do not
close up or paraphrase text remaining after this
excision.
• Mark the fourth copy plainly on both its cover and its
title page with the phrase "Public Docket Material -
contains no information claimed as confidential".
V.
For Further Information
For further information contact John Carley, Chief,
Information Services Branch, Program Management and Support
Division, (703) 305-5240.
W, Ak*n»n
Acting Dirtctor,
Division
Attachment l
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
64
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ATTACHMENT 1
ELEMENTS TO BE INCLUDED IN THE TRANSMITTAL DOCUMENT*
1. Name and address of submitter (or all joint submitters**}
"""Smith Chemical Corporation Jones Chemical Company
1234 West Smith Street -and- 5678 Wilson. Blvd
Cincinnati, OH 98765 Covington, KY 56789
"""Smith Chemical Corp will act as sole agent for all submitters,
2. Regulatory action J,n support of which this package is
submitted
Use the EPA identification number (e.g. 359-EUP-67) if you know
it. Otherwise describe the type of request (e.g. experimental
use permit, data call-in - of xx-xx-xx date).
3. Transmittal date
4. List o^ submitted studies
Vol 1. Administrative materials - forms, previous corres-
pondence with Project Managers, and so forth.
Vol 2. Title of first study in the submittal (Guideline
No.)
Vol n Title of nth study in the submittal (Guideline
No.)
* Applicants commonly provide this information in a tran-
smittal letter. This remains an acceptable practice so
long as all four elements are included.
* Indicate which of the joint submitters is empowered to
act on behalf of all joint submitters in any matter
concerning data compensation or subsequent use or
release of the data.
Company Official:.
Name Signature
Company Name:
Company Contact:
Name Phone
65
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ATTACHMENT 2
SAMPLE STUDY TITLE PAGE FOR A NEWLY SUBMITTED STUDY
Study Title -
(Chemical name) - Magnitude of Residue on Corn
Data Requirement
Guideline 171-4
Author
John C. Davis
; Study Completed On
January 5, 1979
Performing Laboratory
ABC Agricultural Laboratories
940 West Bay Drive
Wilmington, CA 39897
Laboratory Project ID
ABC 47-79
Page 1 of X
(X is the total number of pages in the study)
66
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ATTACHMENT 3
STATEMENTS OF DATA CONFIDENTIALITY CLAIMS
1. No claim of confidentiality under PIFRA §10(d)(1)(A),(B), or
(C) .
STATEMENT OF NO DATA CONFIDENTIALITY CLAIMS
No claim of confidentiality is made for any information
contained in this study on the basis of its falling within
the scope of FIFRA 6§10(d)(1)(A), {B}, or (C).
Company
Company Agent: ; Typed Namg Date:.
Title 1 Signature
2. Claim of confidentiality under FIFRA §10(d)(!)(A), (B), or
STATEMENT OF DATA CONFIDENTIALITY CLAIMS
Information claimed confidential on the basis of its falling
within the scope of FIFRA §10(d)(1)(A), (B), or (C) has been
removed to a confidential appendix, and is cited by
cross-reference number in the body of the study.
Company:
Company Agent: Typed Name Date:
Title Signature
NOTE: Applicants for permanent or temporary tolerances should
note that it is OPp policy that no permanent tolerance, temporary
tolerance, or request for an emergency exemption incorporating an
analytical method, can be approved unless the applicant waives
all claims of confidentiality for the analytical method. These
analytical methods are published in the FDA Pesticide Analytical
Methods Manual, and therefore cannot be claimed as confidential.
OPP implements this policy by returning submitted analytical
methods, for which confidentiality claims have been made, to the
submitter, to obtain the confidentiality waiver before they can
be processed.
67
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ATTACHMENT 4
SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
For any portion of a submitted study that is not described
by FIFRA §10(d)(!)(A), (B), or (C) , but for which you claim
confidential treatment on another basis, the following informa-
tion must be included within a Supplemental Statement of Data
Confidentiality Claims:
• identify specifically by page and line number(s) each
portion of the study for which you claim
confidentiality. *
• Cite the reasons why the cited passage qualifies for
confidential treatment,
• Indicate the length of time--until a specific date or
event, or permanently--for which the information should
be treated as confidential.
• Identify the measures taken to guard against undesired
disclosure of this information.
• Describe the extent to which the information has been
disclosed, and what precautions have been taken in con-
nection with those disclosures.
• Enclose copies of any pertinent determinations of
confidentiality made by EPA, other Federal agencies, of
courts concerning this information.
• If you assert that disclosure of this information would
be likely to result in substantial harmful effects to
you, describe those harmful effects and explain why
they should be viewed as substantial.
• If you assert that the information in voluntarily sub-
mitted, indicate whether you believe disclosure of this
information might tend to lessen the availability to
EPA of similar information in the future, and if so,
how.
68
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ATTACHMENT 5
EXAMPLES OF SEVERAL CONFIDENTIAL ATTACHMENTS
Example 1. (Confidential word or phrase that has been deleted
from the study)
CROSS REFERENCE NUMBER 1. This cross reference number is used in the study
in place of the following words or phrase at the
indicated volume and page references,
DELETED WORDS OR PHRASE: Bi-Kyi BT« myw.1
PAGE LIKE REASON FORJHE DELETION PIFRA REFERENCE
6 14 Identity of Inert Ingredient §10(d)(1) CO
12 25 " "
100 19 " "
Example 2. {Confidential paragraph(s) that have been deleted from the study)
CROSS REFERENCE NUMBER 5 This cross reference number is used in the study
in place of the following paragraph(s) at the
indicated volume and page references.
DELETED PARAGRAPH(S):
( - )
( Reproduce the deleted paragraph{s} here )
( }
PAGE LINES REASON FOR THE DELETION FIFRA REFERENCE
20. 2-17 Description of the quality control process §10(d)(1)(C)
Example 3. (Confidential pages that have been deleted from the study)
CROSS REFERENCE NUMBER ~]_ This cross reference number noted on a place-
holder page is used in place of the following
whole pages at the indicated volume and page
references.
DELETED PAGE(S): are attached immediately behind this page.
PAGE LINES REASON FOR THE DELETION FIFRA REFERENCE
20. 2-17 Description of the product manufacturing process §10(d){!)(A)
69
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ATTACHMENT 6.
SAMPLE GOOD LABORATORY PRACTICE STATEMENTS
Example !_.
This study meets the requirements for 40 CFR Part 160
Submitter
Sponsor
Study Director
Example 2.
This study does not meet the requirements of 40 CFR Part 160, and differs
in the following ways:
1.
2.
3.
Submit ter_
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
70
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ATTACHMENT 7.
FORMAT OP THE SUBHITTAL PACKAGE
Tranwnlttal Docunent.
Related Adrainiatrativc M»t*riala
p., Method of Support Statement, etc.)
Other materials about the aubmittal
(e.g., summaries of groups of stjdt«s
to aid In their z*vi*v).
, subetttttd a*
phy«ic*l •nbitias, according
to the format below.
FORMAT OP SUBMITTED STUDIES
Study title page,
Statement of Confidentiality Claims .
CLP and flagging* «tat«aient« - as appropriate.
LEGEND
ot the *tudy, with English
language tranalation if required,
Append icee to the atudy.
Title fage of the Confidential
Attachm«nt.
Confidential Attachment.
Supplemental Statement
or confidentiality Claim*.
Wh«n flagging requitenants
are finalized.
which *u«t be »ub«itted a«
appropriate to neet e«tat>ii»he
-------
72
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PR Notice 91-2
73
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74
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1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
^ WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
IKS TOWt
PR NOTICE 91-2
NOTICE. TO MANUFACTURERS, PRODUCERS, FORMULATORS,
AND REGISTRANTS OF PESTICIDES
ATTENTION: Persons Responsible for Federal Registration of
Pesticide Products.
SUBJECT: Accuracy of Stated Percentages for Ingredients
Statement
I. PURPOSE:
The purpose of this notice is to clarify the Office of
Pesticide Program's policy with" respect to the statement of
percentages in a pesticide's label's ingredient statement.
Specifically, the amount (percent by weight) of ingredient(s)
specified in the ingredient statement on the label must be stated
as the nominal concentration of such ingredient{s), as that term
is defined in 40 CFR 158,153 (i). Accordingly, the Agency has
established the nominal concentration as the only acceptable
label claim for the amount of active ingredient in the product.
II. BACKGROUND
For some time the Agency has accepted two different methods
of identifying on the label what percentage is claimed for the
ingredientts) 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
75
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CFR 158.175{C) (3) .
The upper and lower certified limits, which must be proposed
in connection with a product's registration, represent the
amounts of an ingredient that may legally be present 40 CPR
158.175. The lower certified limit is used as the enforceable
lower limit for the product composition according to FIFRA
section 12(a)(1){C), while the nominal concentration appearing on
the label would be the routinely achieved concentration used for
calculation of dosages and dilutions.
The nominal concentration would in fact state the greatest
degree of accuracy that is warranted with respect to actual
product composition because the nominal concentration would be
the amount of active ingredient typically found in the product.
It is important for registrants to note that certified
limits for active ingredients are not considered to be trade
secret information under FIFRA section 10(b). In this respect the
certified limits will be routinely provided by EPA to States for
enforcement purposes, since the nominal concentration appearing
on the label may not represent the enforceable composition for
purposes of section 12(a)(1)(C).
III. REQUIREMENTS
As described below under Unit V. " COMPLIANCE SCHEDULE," all
currently registered products as well as all applications for new
registration must comply with this Notice by specifying the
nominal concentration expressed as a percentage by weight as the
label claim in the ingredient{s} statement and equivalence
statements if applicable {e.g., elemental arsenic, metallic zinc,
salt of an acid). In addition, the requirement for performing
sample analyses of five or more representative samples must be
fulfilled. Copies of the raw analytical data must be submitted
with the nominal ingredient label claim. Further information
about the analysis requirement may be found in the 40 CFR
158.170. All products are required to provide certified limits
for each active, inert ingredient, impurities of toxicological
significance{i.e., upper limit(s) only) and on a case by case
basis as specified by EPA. These limits are to be set based on
representative sampling and chemical analysis(i.e., quality
control) of the product.
The format of the ingredient statement must conform to 40
CFR 156-Labeling Requirements For Pesticides and Devices.
After July 1, 1997, all pesticide ingredient Statements must
be changed to nominal concentration.
76
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IV. PRODUCTS THAT REQUIRE EFFICACY DATA-
All pesticides are required to be efficacious. Therefore,
the certified lower limits may not be lower then the minimum
level to achieve efficacy. This is extremely important for
products which are intended to control pests which threaten the
public health, e.g., certain antimicrobial and rodenticide
products. Refer to 40 CFR 153.640,
In those cases where efficacy limits .have been established,
the Agency will not accept certified lower limits which are below
that level for the shelf life of the product.
V. COMPLIANCE SCHEDULE
As described earlier, the purpose of this Notice is to make
the registration process more uniform and more manageable for
both the agency and the regulated community. It is the Agency's
intention to implement the requirements of this notice as
smoothly as possible so as not to disrupt or delay the Agency's
high priority programs, i.e., reregistration, new chemical, or
fast track (FIFRA section 3(c)(3)(B). Therefore,
applicants/registrants are expected to comply with the
requirements of this Notice as follows:
(1) Beginning July 1, 1991, all new product registrations
submitted to the Agency are to comply with the
requirements of this Notice.
(2) Registrants having products subject to reregistration
under FIFRA section 4(a) are to comply with the
requirements of this Notice when specific products are
called in by the Agency under Phase V of the
Reregistration Program.
77
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(3) All other products/applications that are not subject to
(1) and (2) above will have until July 1, 1997, to
comply with this Notice. Such applications should note
"Conversion to Nominal Concentrations on the
application form. These types Or amendments will not be
handled as "Past Track" applications but will be
handled as routine requests.
VI. FOR FURTHER INFORMATION
Contact Tyrone Aiken for information or questions concerning
this notice on (703) 308-7031.
Ann* B. ticviaay,
Registration Division (H-75Q5
78
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APPENDIX F. Product Specific Data Call-In
79
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80
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DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment A of this Notice, the Data Call-In Chemical Status Sheet, to
submit certain 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 HI 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 m-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 M-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 I36a(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).
This Notice is divided into six sections and seven Attachments. The Notice itself contains
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information and instructions applicable to all Data Call-In Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You Are Receiving This Notice
Section II - Data Required By This Notice
Section HI- Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable Adverse
Effects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2 - Product-Specific Data Call-In Response Form
3 - Requirements Status and Registrant's Response Form
4 - EPA Grouping of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - EPA Acceptance Criteria
7 - List of Registrants ^Receiving This Notice
8 - Cost Share and Data Compensation Forms, and Product Specific Data Report
Form
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient and reevaluated the data
needed to support continued registration of the subject active ingredient. The Agency has
concluded that the only additional data necessary are product specific data. No additional
generic data requirements are being imposed. You have been sent this Notice because you have
product(s) containing the subject active ingredient.
SECTION n. DATA REQUIRED BY THIS NQTICE
H-A. DATA REQUIRED
The product specific data required by this Notice are specified in Attachment C,
Requirements Status and Registrant's Response Form. Depending on the results of the studies
required in this Notice, additional testing may be required.
H-B. SrHRDTTT.F, FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements specified in
Attachment C, Requirements Status and Registrant's Response Form, within the time frames
provided.
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H-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been
established.
These EPA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-487-4650),
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OBCD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (40 CFR § 158.70), When using the OECD
protocols, they should be modified as appropriate so that the data generated by the study will satisfy
the requirements of 40 CFR § 158, Normally, the Agency will not extend deadlines for complying
with data requirements when the studies were not conducted in accordance with acceptable
standards. The OECD protocols are available from OECD, 1750 Pennsylvania Avenue N,W.,
Washington, D.C, 20006.
All new studies and proposed protocols submitted in response to this Data Call-in Notice
must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
D-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3fcK2^fFt NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data CalHn does jot in any way supersede or change the
requirements of any previous Data Call-InfsL or any other agreements entered into with the Agency
pertaining to such prior Notice. Registrants must comply with the requirements of all Notices to
avoid issuance of a Notice of Intent to Suspend their affected products.
SECTION m. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
m-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for product specific data must
be submitted to the Agency within 90 days after your receipt of this Notice, Failure to adequately
respond to this Notice within 90 days of your receipt will be a basis for issuing a Notice of Intent
to Suspend (NOIS) affecting your products. This and other bases for issuance of NOIS due to
failure to comply with this Notice are presented in Section IV-A and IV-B.
m-B. OPTIONS FOR RESPONDING TO THE AGENCY
The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this notice or
(c) request a data waiver(s).
A discussion of how to respond if you chose the Voluntary Cancellation option is presented
below. A discussion of the various options available for satisfying the product specific data
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requirements of this Notice is contained in Section IH-C. A discussion of options relating to
requests for data waivers is contained in Section ffl-D.
There are two forms that accompany this Notice of which, depending upon your response,
one or both must be used in your response to the Agency, These forms are the Data-Call-in
Response Form, and the Requirements Status and Registrant's Response Form. Attachment B and
Attachment C. The Data Call-In Response Form must be submitted as part of every response to this
Notice. In addition, one copy of the Requiremenl^Status and Registrant's Response Form must
be submitted for each product listed on the Data Call-in Response Form unless the voluntary
cancellation option is selected or unless the product is identical to another (refer to the instructions
for completing the Data Call-In Response Form in Attachment B). Please note that the company's
authorized representative is required to sign the first page of the Data Call-in Response Form and
Requirements Status and Registrant's Response Form (if this form is required) and initial any
subsequent pages. The forms contain separate detailed instructions on the response options. Do not
alter the printed material. If you have questions or need assistance in preparing your response, call
or write the contact person(s) identified in Attachment A.
1. Voluntary Cancellation - You may avoid the requirements of this Notice by requesting
voluntary cancellation of your product(s) containing the active ingredient that is the subject of this
Notice. If you wish to voluntarily cancel your product, you must submit a completed Data Call-In
Response Form, indicating your election of this option. Voluntary cancellation is item number 5
on the Data CaUJn Response Form. If you choose this option, this is the only form that you are
required to complete.
If you chose to voluntarily cancel your product, further sale and distribution of your product
after the effective date of cancellation must be in accordance with the Existing Stocks provisions
of this Notice which are contained in Section TV-C.
2. Satisfying the Product jpecific Data Requirements of this Notice There are various
options available to satisfy the product specific data requirements of this Notice. These options are
discussed in Section HI-C of this Notice and comprise options 1 through 6 on the Requirements
Status and Registrant's Response Fjym and item numbers 7a and 7b on the Data Call-In Response
Form. Deletion of a use(s) and the low volume/minor use option are not valid options for fulfilling
product specific data requirements.
3. Request for Product Specific Data Waivers. Waivers for product specific data are
discussed in Section ffl-D of this Notice and are covered by option 7 on the Requirements Status
and Registrant's Response Form. If you choose one of these options, you must submit both forms
as well as any other information/data pertaining to the option chosen to address the data
requirement.
m-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-in Response Form that you agree to satisfy the product
specific data requirements (i.e. you select item number 7a or 7b), then you must select one of the
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six options on the Requirements Status^nd Registrant's Response Form related to data production
for each data requirement. Your option selection should be entered under item number 9,
"Registrant Response." The six options related to data production are the first six options discussed
under item 9 in the instructions for completing the Requirements Status and Registrants Response
Form. These six options are listed immediately below with information in parentheses to guide
registrants to additional instructions provided in this Section. The options are:
(1). I will generate and submit data within the specified time frame (Developing Data)
(2) I have entered into an agreement with one or more registrants to develop data jointly
(Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an existing
study that has been submitted but not reviewed by the Agency (Citing an Existing
Study)
Option 1. Developing Data — If you choose to develop the required data it must be in
conformance with Agency deadlines and with other Agency requirements as referenced herein and
in the attachments. All data generated and submitted must comply with the Good Laboratory
Practice (GLP) rule (40 CFR Part 160), be conducted according to the Pesticide Assessment
Guidelines (PAG), and be in conformance with the requirements of PR Notice 86-5.
The time frames in the Requirements^Status and Registrant's Response Form are the time
frames that the Agency is allowing for the submission of completed study reports. The noted
deadlines run from the date of the receipt of this Notice by the registrant. If the data are not
submitted by the deadline, each registrant is subject to receipt of a Notice of Intent to Suspend the
affected registration(s).
If you cannot submit the data/reports to the Agency in the time required by this Notice and
intend to seek additional time to meet the requirements(s), you must submit a request to the Agency
which includes: (1) a detailed description of the expected difficulty and (2) a proposed schedule
including alternative dates for meeting such requirements on a step-by-step basis. You must explain
any technical or laboratory difficulties and provide documentation from the laboratory performing
the testing. While EPA is considering your request, the original deadline remains. The Agency
will respond to your request in writing. If EPA does not grant your request, the original deadline
remains. Normally, extensions can be requested only in cases of extraordinary testing problems
beyond the expectation or control of the registrant. Extensions will not be given in submitting the
90-day responses. Extensions will not be considered if the request for extension is not made in a
timely fashion; in no event shall an extension request be considered if it is submitted at or after the
lapse of the subject deadline.
Option 2. Agreement to Share jn 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
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on the same data. If this is the case, data may be generated for just one of the products in the
group. The registration number of the product for which data will be submitted must be noted in
the agreement to cost share by the registrant selecting this option. If you choose to enter into an
agreement to share in the cost of producing the required data but will not be submitting the data
yourself, you must provide the name of the registrant who will be submitting the data. You must
also provide EPA with documentary evidence that an agreement has been formed. Such evidence
may be your letter offering to join in an agreement and the other registrant's acceptance of your
offer, or a written statement by the parties that an agreement exists. The agreement to produce the
data need not specify all of the terms of the final arrangement between the parties or the mechanism
to resolve the terms. Section 3(c)(2)(B) provides that if the parties cannot resolve the terms of the
agreement they may resolve their differences through binding arbitration.
Option 3, Offer to Share in the Cost of Data Development — This option only applies to
acute toxicity and certain efficacy data as described in option 2 above. If you have made an offer
to pay in an attempt to enter into an agreement or amend an existing agreement to meet the
requirements of this Notice and have been unsuccessful, you may request EPA (by selecting this
option) to exercise its discretion not to suspend your registration(s), although you do not comply
with the data submission requirements of this Notice. EPA has determined that as a general policy,
absent other relevant considerations, it will not suspend the registration of a product of a registrant
who has in good faith sought and continues to seek to enter into a joint data development/cost
sharing program, but the other registrant(s) developing the data has refused to accept your offer.
To qualify for this option, you must submit documentation to the Agency proving that you have
made an offer to another registrant (who has an obligation to submit data) to share in the burden
of developing that data. You must also submit to the Agency a completed EPA Form 8570-32,
Certification of Offer to Cost Share in the Development of Data, Attachment G. In addition, you
must demonstrate that the other registrant to whom the offer was made has not accepted your offer
to enter into a cost sharing agreement by including a copy of your offer and proof of the other
registrant's receipt of that offer (such as a certified mail receipt). Your offer must, in addition to
anything else, offer to share in the burden of producing the data upon terms to be agreed or failing
agreement to be bound by binding arbitration as provided by FIFRA section 3(c)(2)(B)(iii) and must
not qualify this offer. The other registrant must also inform EPA of its election of an option to
develop and submit the data required by this Notice by submitting a Data Call-In Response Form
and a Requirements Status and Registrant's Response Form committing to develop and submit the
data required by this Notice.
In order for you to avoid suspension under this option, you may not withdraw your offer
to share in the burdens of developing the data. In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this Notice. If the other registrant fails
to develop the data or for some other reason is subject to suspension, your registration as well as
that of the other registrant will normally be subject to initiation of suspension proceedings, unless
you commit to submit, and do submit the required data in the specified time frame. In such cases,
the Agency generally will not grant a time extension for submitting the data.
Option 4, Submitting an Existing Study — If you choose to submit an existing study in
response to this Notice, you must determine that the study satisfies the requirements imposed by
this Notice. You may only submit a study that has not been previously submitted to the Agency
or previously cited by anyone. Existing studies are studies which predate issuance of this Notice.
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Do not use this option if you are submitting data to upgrade a study. (See Option 5),
You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the required
date of submission. The Agency may determine at any time that a study is not valid and needs to
be repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly met:
a. You must certify at the time that the existing study is submitted that the raw data and
specimens from the study are available for audit and review and you must identify
where they are available. This must be done in accordance with the requirements
of the Good Laboratory Practice (GLP) regulation, 40 CFR Part 160. As stated in
40 CFR 160.3(j) " 'raw data' means any laboratory worksheets, records,
memoranda, notes, or exact copies thereof, that are the result of original
observations and activities of a study and are necessary for the reconstruction and
evaluation of the report of that study. In the event that exact transcripts of raw data
have been prepared (e.g., tapes which have been transcribed verbatim, dated, and
verified accurate by signature), the exact copy or exact transcript may be substituted
for the original source as raw data. 'Raw data' may include photographs, microfilm
or microfiche copies, computer printouts, magnetic media, including dictated
observations, and recorded data from automated instruments." The term
"specimens", according to 40 CFR 160.3(k), means "any material derived from a
test system for examination or analysis."
b. Health and safety studies completed after May 1984 must also contain all GLP-
required quality assurance and quality control information, pursuant to the
requirements of 40 CFR Part 160. Registrants must also certify at the time of
submitting the existing study that such GLP information is available for post-May
1984 studies by including an appropriate statement on or attached to the study signed
by an authorized official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3
Technical Guidance and that the study has been conducted according to the Pesticide
Assessment Guidelines (PAG) or meets the purpose of the PAG (both available from
NTIS). A study not conducted according to the PAG may be submitted to the
Agency for consideration if the registrant believes that the study clearly meets the
purpose of the PAG. The registrant is referred to 40 CFR 158.70 which states the
Agency's policy regarding acceptable protocols. If you wish to submit the study, you
must, in addition to certifying that the purposes of the PAG are met by the study,
clearly articulate the rationale why you believe the study meets the purpose of the
PAG, including copies of any supporting information or data. It has been the
Agency's experience that studies completed prior to January 1970 rarely satisfied the
purpose of the PAG and that necessary raw data are usually not available for such
studies.
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If you submit an existing study, you must certify that the study meets all requirements of
the criteria outlined above.
If 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 toxicology studies
generally will have been classified as "core-guideline" or "core minimum." For all other
disciplines the classification would be "acceptable." With respect to any studies for which you wish
to select this option you must provide the MRID number of the study you are citing and, if the
study has been reviewed by the Agency, you must provide the Agency's classification of the study.
If you are citing a study of which you are not the original data submitter, you must submit
a -completed copy of EPA Form 8570-31, Certification with Respect to Data Compensation
Requirements.
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Registrants who select one of the above 6 options must meet al] of the requirements
described in the instructions for completing the Data Call-in Response Form and the Requirements
Status and Registrant's Response Form, as appropriate.
ffl-D REQUESTS FOR DATA W;
If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete justification for the request, including technical reasons,
data and references to relevant EPA regulations, guidelines or policies. (Note: any supplemental
data must be submitted in the format required by PR Notice 86-5), This will be the only
opportunity to state the reasons or provide information in support of your request. If the Agency
approves your waiver request, you wiU not be required to supply the data pursuant to section
3(c)(2)(B) of F1FRA. If the Agency denies your waiver request, you must choose an option for
meeting the data requirements of this Notice within 30 days of the receipt of the Agency's decision.
You must indicate and submit the option chosen on the Requirements Status and Registrant's
Response Form. Product specific data requirements for product chemistry, acute toxicity and
efficacy (where appropriate) are required for all products and the Agency would grant a waiver only
under extraordinary circumstances. You should also be aware that submitting a waiver request will
not automatically extend the due date for the study in question. 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
FV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice due to
failure by a registrant to comply with the requirements of this Data Call-in Notice, pursuant to
FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a Notice of Intent to
Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 .days of your receipt of this
Notice.
2. Failure to submit on the required schedule an acceptable proposed or final protocol
when such is required to be submitted to the Agency for review,
3, Failure to submit on the required schedule an adequate progress report on a study
as required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this Notice.
5. Failure to take a required action or submit adequate information pertaining to any
option chosen to address the data requirements (e.g., any required action or
information pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task Forces,
failure to comply with the terms of an agreement or arbitration concerning joint data
development or failure to comply with any terms of a data waiver),
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6. Failure to submit supportable certifications as to the conditions of submitted studies,
as required by Section IH-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost of
developing data and provided proof of the registrant's receipt of such offer or failure
of a registrant on whom you rely for a generic data exemption either to:
a. inform EPA of intent to develop and submit the data required by this Notice
on a Data Call-In Response Form and a Requirements Status and^Registrant's
Response Form: .
b, 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
UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds for
suspension include, but are not limited to, failure to meet any of the following:
1. EPA requirements specified in the Data Call-In Notice or other documents incorporated
by reference (including, as applicable, EPA Pesticide Assessment Guidelines, Data
Reporting Guidelines, and GeneTox Health Effects Test Guidelines) regarding the design,
conduct, and reporting of required studies. Such requirements include, but are not limited
to, those relating to test material, test procedures, selection of species, number of animals,
sex and distribution of animals, dose and effect levels to be tested or attained, duration of
test, and, as applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the incorporation of
any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner of reporting,
the completeness of results, and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or included in this Notice or contained
in PR 86-5. All studies must be submitted in the form of a final report; a preliminary
report will not be considered to fulfill the submission requirement.
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IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing stocks
of a pesticide product which has been suspended or cancelled if doing so would be consistent with
the purposes of the Act.
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding would generally not be
consistent with, the Act's purposes. Accordingly, the Agency anticipates granting registrants
permission to sell, distribute, or use existing stocks of suspended product(s) only in exceptional
circumstances. If you believe such disposition of existing stocks of your product(s) which may be
suspended for failure to comply with this Notice should be permitted, you have the burden of
clearly demonstrating to EPA that granting such permission would be consistent with the Act. You
must also explain why an "existing stocks" provision is necessary, including a statement of the
quantity of existing stocks and your estimate of the time required for their sale, distribution, and
use. Unless you meet this burden the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this Notice and
your product is in full compliance with all Agency requirements, you will have, under most
circumstances, one year from the date your 90 day response to this Notice is due, to sell, distribute,
or use existing stocks. Normally, the Agency will allow persons other than the registrant such as
independent distributors, retailers and end users to sell, distribute or use such existing stocks until
the stocks are exhausted. Any sale, distribution or use of stocks of voluntarily cancelled products
containing an active ingredient for which the Agency has particular risk concerns will be
determined on case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required by
this Notice will not result in the Agency granting any additional time to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was due unless you demonstrate
to the Agency that you are in full compliance with all Agency requirements, including the
requirements of this Notice. For example, if you decide to voluntarily cancel your registration six
months before a 3 year study is scheduled to be submitted, all progress reports and other
information necessary to establish that you have 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.
TOREPGR1
REGISTRANTS'
LE ADVERS
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.
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SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person(s) listed in Attachment A, the Data Call-In Chemical Status Sheet.
All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data CalMn Response Form and a completed
Requirements Status and Registrants Response Form (Attachment B for generic data and
Attachment' C for product specific data) and any other documents required by this Notice, and
should be submitted to the contact person(s) identified in Attachment A. If the voluntary
cancellation or generic data exemption option is chosen, only the Data Call-In Response Form need
be submitted.
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,
Daniel M. Barolo, Director
Special Review and
Reregistration Division
Attachments
1 -
2 -
3 -
4 -
5 -
6 -
7 -
Data Call-In Chemical Status Sheet
Product-Specific Data Call-In Response Form
Requirements Status ^nd Registrant's Response Form
EPA Grouping of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
EPA Aence Critra
List of Registrants Receiving This Notice
Cost Share and Data Compensation Forms, and Product Specific Data Report Form
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Attachment 1. Chemical Status Sheet
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BROMINE DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have
product(s) containing Bromine.
This Product Specific Data Call-In Chemical Status Sheet, contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregistration of
Bromine. This attachment is to be used in conjunction with (1) the Product Specific Data Call-In
Notice, (2) the Product Specific Data Call-In Response Form (Attachment B), (3) the
Requirements Status and Registrant's Form (Attachment C), (4) EPA's Grouping of End[-]Use
Products for Meeting Acute Toxicology Data Requirement (Attachment 0), (5) the EPA
Acceptance Criteria (Attachment E), (6) a list of registrants receiving this DCI (Attachment F)
and (7) the Cost Share and Data Compensation Forms in replying to this Bromine Product
Specific Data Call[-]In (Attachment G), Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for Bromine are
contained in the Requirements Status and Registrant's Response. Attachment C. The Agency
has concluded that additional data on Bromine are needed for specific products. These data are
required to be submitted to the Agency within the time frame listed. These data are needed to
fully complete the reregistration of all eligible Bromine products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of Bromine, please contact Mark
Wilhite at (703) 308-8586.
If you have any questions regarding the product specific data requirements and
procedures established by this Notice, please contact Franklin Rubis (703) 308-8184
All responses to this Notice for the Product Specific data requirements should be
submitted to:
Accelerated Reregistration Branch, Product Manager Team 81
Product Reregistration Branch
Special Review and Reregistration Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Bromine
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Attachment 2. Product Specific Data Call-In Response
Forms (Form A inserts) Plus Instructions
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96
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INSTRUCTIONS FOR COMPLETING THE "DATA CALL-IN RESPONSE" FORM FOR
PRODUCT SPECIFIC DATA
Item 1-4. Already completed by FJA,
Item 5. If you wish to voluntarily cancel your product, answer "yes™. If you choose this
option, you will not have to provide the data required by the Data Call-In Notice and
you will not have to complete any other forms. Further sale and distribution of your
product after the effective date of cancellation must be in accordance with the
Existing Stocks provision of the Data Call-In Notice (Section IV-C).
Item 6. Not applicable since this form calls in product specific data only. However, if your
product is identical to another product and you qualify for a data exemption, you
must respond with "yes" to Item 7a (MUP) or 7B (EUP) on this form, provide the
EPA reregistration numbers of your source (s); you would not complete the
requirements status and registrant's response" form. Examples of such products
include repackaged products and Special Local Needs (Section 24c) products which
are identical to federally registered products.
Item 7a. For each manufacturing use product (MUP) for which you wish to maintain
registration, you must agree to satisfy the data requirements by responding "yes."
Item 7b. For each end use product (EUP) for which you wish to maintain registration, you
must agree to satisfy the data requirements by responding "yes." if you are
requesting a data waiver, answer "yes" here; in addition, on the "Requirements
Status and Registrant's Response" form under Item 9, you must respond with option
7 (Waiver Request) for each study for which you are requesting a waiver. See item
6 with regard to identical products and data exemptions.
Items 8-11. Self-explanatory.
Note: You may provide additional information that does not fit on this form in a signed letter
that accompanies this form. For example, you may wish to report that your product has
already been transferred to another that you have already voluntarily cancelled this product.
For these cases, please supply all relevant details so that EPA can ensure that its records
are correct.
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98
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Attachment 3. Product Specific Requirement Status and
Registrant's Response Forms (Form B inserts) and
Instructions
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100
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE" FORM FOR PRODUCT SPECIFIC DATA
Item 1-3. Completed by EPA. Note the unique identifier number assigned by EPA in item 3.
This number must be used in the transmittal document for any data submissions in
response to this Data Call-in Notice,
Item 4. The guidelines reference numbers of studies required to support the product's
continued registration are identified. These guidelines, in addition to the
requirements specified in the Notice, govern the conduct of the required studies.
Note that series 61 and 62 in product chemistry are now listed under 40 CFR
158.155 through 158.180, Subpart c.
Item 5, The study title associated with the guideline reference number is identified.
Item 6. The use patters (s) of the pesticide associated with the product specific requirements
is (are) identified. For most product specific data requirements, all use patterns are
covered by the data requirements. In the case of efficacy data, the required studies
only pertain to products which have the use sites and/ or pests indicated.
Item 7. The substance to be tested is identified by EPA, For product specific data, the
product as formulated for sale and distribution is the test substance, except in rare
cases.
Item 8. The due date for submission of each study is identified. It is normally based on 8
months after issuance of the Reregistration Eligibility Documents unless EPA
determines that a longer time period is necessary.
Item 9. Enter Only one of the following response codes for each data requirement to show
how you intend to comply with the data requirements listed in this table. Fuller
descriptions of each option are contained in the Data Call-In Notice.
1. I will generate and submit data by the specified due date (Developing Data).
By indicating that I have chosen this option, I certify that I will comply with all the
requirements pertaining to the conditions for submittal of this study as outlined in
the Data Call-In Notice.
2. I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing). I am submitting a copy of this agreement. I understand that
this option is available on for acute toxkity or certain efficacy data and only if EPA
indicates in an attachment to this notice that my product is similar. Enough to
another product to qualify for this option. I certify that another party in the
agreement is committing to submit or provide the required data; if the required study
is not submitted on time, my product my be subject to suspension.
3. I have made offers to share in the cost to develop data (Offers to Cost Share).
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I understand that this option is available only for acute toxicity or certain efficacy
data and only if EPA indicates in an attachment to this Data Call-In Notice that my
product is similar enough to another product to qualify for this option. I am
submitting evidence that I have made an offer to another registrant (who has an
obligation to submit data) to share in the cost of that data, I am also submitting a
completed " Certification of offer to Cost Share in the Development Data" form.
I am including a copy of my offer and proof of the other registrant's receipt of that
offer. I am identifying the party which is committing to submit or provide the
require data; if the required study is not submitted on time, my product may be
subject to suspension. I understand that other terms under Option 3 in the Data
Call-in Notice (Section in-C.l,) apply as well.
4. By the specified due date, I will submit an existing study that has not been
submitted previously to the Agency by anyone (submitting an Existing Study). I
certify that this study will meet all the requirements for submittal of existing data
outlined in option 4 in the Data Call-In Notice (Section HI-C.1.) and will meet the
attached acceptance criteria (for acute toxicity and product chemistry data). I will
attach the needed supporting information along with this response. I also certify that
I have determined that this study will fill the data requirement for which I have
indicated this choice.
5. By the specified due date, I will submit or cite data to upgrade a study
classified by the Agency as partially acceptable and upgrade (upgrading a study).
I will submit evidence of the Agency's review indicating that the study may be
upgraded and what information is required to do so. I will provide the MRID or
Accession number of the study at the due date. I understand that the conditions for
this Option outlined Option 5 in the Data Call-In Notice (Section IH-C.l.) apply.
6. By the specified due date, I will cite an existing study that the Agency has
classified as acceptable or an existing study that has been submitted but not reviewed
by the Agency (Citing an Existing Study). If I am citing another registrant's study,
I understand that this option is available only for acute toxicity or certain efficacy
data and only if the cited study was conducted on my product, an identical product
or a product which EPA has "grouped" with one or more other products for
purposes of depending on the same data. I may also choose this option if I am citing
my own data. In either case, I will provide the MRID or Accession number (s)
number (s) for the cited data on a "Product Specific Data Report" form or in a
similar format. If J cite another registratrant's data, I will submit a completed
"Certification With Respect To Data Compensation Requirements" form.
7. I request a waiver for this study because it is inappropriate for my product
(Waiver Request). I am attaching a complete justification for this request, including
technical reasons, data and references to relevant EPA regulations, guidelines or
policies. fNote: any supplemental data must be submitted in the format required by
P.R. Notice 86-5]. I understand that this is my only opportunity to state the reasons
or provide information in support of my request. If the Agency approves my waiver
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request, I will not be require to supply the data pursuant to Section 3(c) (2) (B) of
FIFRA. If the Agency denies my waiver request, I must choose a method of
meeting the data requirements of this Notice by the due date stated by this Notice.
In this case, I must, within 30 days of my receipt of the Agency's written decision,
submit a revised "Requirements Status chosen, I also understand that the deadline
for submission of data as specified by the original data cal-in notice will not change.
Items 10-13. Self-explanatory.
NOTE; You may provide additional 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.
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104
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Attachment 4. EPA Batching of End-Use Products for
Meeting Data Requirements for Reregistration
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106
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EPA'S BATCHING OF BROMINE PRODUCTS FOR MEETING ACUTE TOXICJTY
DATA REQUIREMENTS FOR REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the
acute toxicity data requirements for reregistration of products containing the active
ingredient bromine, the Agency has batched products which can be considered similar
for purposes of acute toxicity. Factors considered in the sorting process include each
product's active and inert ingredients (identity, percent composition and biological
activity), type of formulation (e.g., emulsifiabie concentrate, aerosol, wettable powder,
granular, etc.), and labeling (e.g., signal word, use classification, precautionary labeling,
etc.). Note that the Agency is not describing batched products as "substantially similar"
since some products within a batch may not be considered chemically simitar or have
identical use patterns.
Batching has been accomplished using the readily available information described
above, and frequently acute toxicity data on individual products has been found to be
incomplete. Notwithstanding the batching process, the Agency reserves the right to
require, at any time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit
or cite a single battery of six acute toxicological studies to represent a!! the products
within that batch. It t's the registrants' option to participate in the process with all other
registrants, only some of the other registrants, or only their own products within a batch,
or to generate all the required acute toxicological studies for each of their own products.
If a registrant chooses to generate the data for a batch, he/she must use one of the
products within the batch as the test material. If a registrant chooses to rely upon
previously submitted acute toxicity data, he/she may do so provided that the data base
is complete and valid by today's standards (see acceptance criteria attached), the
formulation tested is considered by EPA to be similar for acute toxicity, and the
formulation has not been significantly altered since submission and acceptance of the
acute toxicity data. Regardless of whether new data is generated or existing data is
referenced, registrants must clearly identify the test material by EPA Registration Number.
In deciding how to meet the product specific data requirements, registrants must
follow the directions given in the Data Call-In Notice and its attachments appended to the
RED. The DCI Notice contains two response forms which are to be completed and
submitted to the Agency within 90 days of receipt The first form, "Data Call-In
Response," asks whether the registrant will meet the data requirements for each product.
The second form, "Requirements Status and Registrant's Response," lists the product
specific data required for each product, including the standard six acute toxicity tests. A
registrant who wishes to participate in a batch must decide whether he/she will provide
the data or depend on someone else to do so. If a registrant supplies the data to
support a batch of products, he/she must select one of the following options: Developing
Data (Option 1), Submitting an Existing Study (Option 4), Upgrading an Existing Study
(Option 5) or Citing an Existing Study (Option 6). If a registrant depends on another's
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data, he/she must choose among: Cost Sharing {Option 2), Offers to Cost Share (Option
3) or Citing an Existing Study (Option 6). If a registrant does not want to participate in a
batch, the choices are Options 1, 4, 5 or 6. However, a registrant should know that
choosing not to participate in a batch does not preclude other registrants in the batch
from citing his/her studies and offering to cost share (Option 3) those studies.
Table I shows the two products which were batched together.
EPA REG. NO.
2623-3
59454-1
% of Bromine
30.0% - Bromine
30.0% - Bromine
Formulation Type
Impregnated Material
Impregnated Material
Table II shows the two remaining products which was not batched. These products were
not considered similar for purposes of acute toxicity. The registrant of these products is
responsible for meeting the acute toxicity data requirements specified in the data matrix.
EPA REG. NO.
% of Bromine
& Other Active Ingredients
Formulation Type
6768*8
00.04% - Bromine
25.00% - Isopropyl Alcohol
00.21% - O-Phenylphenol
00.69% - Diisobutytphenoxyethoxy
Ethyl Dimethyl Benzyl
Ammonium Chloride Monohydrate
00.33% - N-Octyl Blcydoheptene
Dicarboximide
00.20% - Piperonyf Butoxide
00.10% - Pyrethrins
Ready to Use Spray
6768-9
00.04% - Bromine
00.21% - O-Phenylphenol
00.69% - Diisobutylphenoxyethoxy
Ethyl Dimethyl Benzyl
Ammonium Chloride Monohydrate
Ready to Use Spray
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Attachment 5. EPA Acceptance Criteria
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110
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SUBDIVISION D
Guideline Study Title
Series 61 Product Identity and Composition
Series 62 Analysis and Certification of Product Ingredients
Series 63 Physical and Chemical Characteristics
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61 Product Identity and Composition
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. _ Name of technical material tested (include product name and trade name, if appropriate),
2. _ Name, nominal concentration, and certified limits (upper and lower) for each active ingredient and each
intentionally-added inert ingredient.
3.__ _ Name and upper certified limit for each impurity or each group of impurities present at _>_ 0,1% by /
weight and for certain toxicologically significant impurities (e.g., dioxins, nitrosamines) present at'
<0.1%. ,
4._ _ Purpose of each active ingredient and each intentionally-added inert.
5. _ Chemical name from Chemical Abstracts index of Nomenclature and Chemical Abstracts Service (CAS)
Registry Number for each active ingredient and, if available, for each intentionally-added inert,
6. _ Molecular, structural, and empirical formulas, molecular weight or weight range, and any company
assigned experimental or internal code numbers for each active ingredient.
7.
Description of each beginning material in the manufacturing process,
_______ EPA Registration Number if registered; for other beginning materials, the following:
_ Name and address of manufacturer or supplier,
_ Brand name, trade name or commercial designation.
_ Technical specifications or data sheets by which manufacturer or supplier describes composition,
properties or toxicity,
8. _ Description of manufacturing process.
_______ Statement of whether batch or continuous process.
_ Relative amounts of beginning materials and order in which they are added.
_ Description of equipment.
_ Description of physical conditions (temperature, pressure, humidity) controlled in each step and
the parameters that are maintained.
_ Statement of whether process involves intended chemical reactions.
_ Flow chart with chemical equations for each intended chemical reaction.
_ Duration of each step of process.
_ Description of purification procedures.
_ Description of measures taken to assure quality of final product.
9. _ Discussion of formation of impurities based OD established chemical theory addressing (1) each impurity
which may be present at >_ 0.1% or was found at >_ 0.1% by product analyses and (2) certain
toxicologically significant impurities (see #3).
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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 amioes/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 lexicologically
significant impurities at <0.l% along with explanation of how limit determined.
9. Analytical methods to verify certified limits of each active ingredient and impurities (latter not required
if exempt from requirement of tolerance or if generally recognized as safe by FDA) are fully described.
10. Analytical methods (as discussed in #9) to verify certified limits validated as to their precision and
accuracy.
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63 Physical and Chemical Characteristics
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered,
Does your study meet the following acceptance criteria?
63-2 Color
Verbal description of coloration {or lack of it)
L 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 lbs/ft3
or Ibs/gallon.]
63-8 Solubility
Determined in distilled water and representative polar and non-polar solvents, including those used in
formulations and analytical methods for the pesticide
Measured at about 20-25° C
Reported in g/lOO 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)
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63-11 Octanol/water Partition Coefficient
Measured at about 20-25° C
Experimentally determined and description of procedure provided (preferred method-45 Fed. Register
77350}
Data supporting reported value provided
63-12 pH
Measured at about 20-25° C
Measured following dilution or dispersion in distilled water
63-13 Stability :
Sensitivity to metal ions and metal determined
Stability at normal and elevated temperatures
Sensitivity to sunlight determined
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SUBDIVISION F
Guideline Study Title
81-1 Acute Oral Toxicity in the Rat
81-2 Acute Dermal Toxicity in the Rat, Rabbit or Guinea Kg
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
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81-1 Acute Oral Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. At least 5 young adult rats/sex/group.
3. Dosing, single oral may be administered over 24 hrs.
4." Vehicle control if other than water.
5. Doses tested, sufficient to determine a tpxicity category or a limit dose (5000 mg/kg),
6. Individual observations at least once a day.
7. Observation period to last at least 14 (Jays, or until all test animals appear normal whichever is longer.
8. Individual daily observations.
9. Individual body weights.
10. Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be required for every study.
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81-2 Acute Dermal toxicity in the Rat, Rabbit or Guinea Kg
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. At least 5 animal s/sex/group.
3.^ Rats 200-300 gin, rabbits 2.0-3.0 kg or guinea pigs 350-450 gm.
4. Dosing, single derma],
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 an * are supplemental and may not be required for every study.
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81-3 Acute Inhalation Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Product is a gas, a solid which may produce a significant vapor hazard based OD toxicity and expected use
or contains particles of inbalable size for man (aerodynamic diameter 15 pm or less).
3. At least 5 young adult rats/sex/group.
4. Dosing, at least 4 hours by inhalation.
5. Chamber air flow dynamic, at least 10 air changes/hour, at least 19% oxygen content.
6._ Chamber temperature, 22° C (±2°), relative humidity 40-60$.
7. Monitor rate of air flow.
8. Monitor actual concentrations of test material in breathing zone.
9. Monitor aerodynamic particle size for aerosols.
10. Doses tested, sufficient to determine a toxicity category or a limit dose (5 mg/L actual concentration of
respirable substance).
11. Individual observations at least once a day.
12. Observation period to last at least 14 days,
13. Individual body weights,
14, Gross necropsy on all animals.
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81-4 Primary Eye Irritation in the Rabbit
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive, causes severe
dermal irritation or has a pH of <2 or _>_! 1.5.
3. 6 adult rabbits.
4. Dosing, instillation into the conjunctiva! sac of one eye
per animal,
5. Dose, 0.1 ml if a liquid; 0,1 ml or not more than 100 mg if a solid, paste or particulate substance.
6. Solid or granular test material ground to a fine dust,
7. Eyes not washed for at leasl 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 «n * are supplemental and may not be required for ever}' study,
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81-5 Primary Dermal Irritation Study
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive or has a pH of <2 or ^11.5.
3. 6 adylt 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 cm1.
8. Application site covered with a gauze patch held in place with nomrritating 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 an * are supplemental and may not be required for every study.
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81-6 Dermal Sensitization in the Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc),
2. Study not required if material is corrosive or has a
pHof<2or .>11.5.
3. One of the following methods is utilized:
' Freund's complete adjuvant test
____ Guinea pig maximization test
Split adjuvant technique
Buehler test
Open epicutaneous test
Mauer optimization test
Footpad technique in guinea pig.
4. Complete description of test.
5.* Reference for test.
6. Test followed essentially as described in reference document.
7. Positive control included (may provide historical data conducted within the last 6 months).
Criteria marked with an * are supplemental and may not be required for every study.
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Attachment 6. List of All Registrants Sent This Data Call-In (insert)
Notice
123
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124
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Attachment 7. Cost Share Data Compensation Form, and Confidential
Statement of Formula Form
125
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126
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K)
Confidential Business Information: Do*s Not Conttin flt»tion»l Security
OfCD/V w«hj«QW«. oc awto
v C rM Confidential Statement of Formula
1 Mams and Addr*»s vl Applicant/ R«giitrarn fingludf ZIP Cods)
3 Product N»ma
EPA USE ONLY
1O Component! in Formulation (List « KtutHf iriiroductti
imo ih» torrmituien. Grtc comment? tcctftfct ciitmktl
ntirv, irmdv ntfrtf. indCAS imaiOtrl
f In formation (£.0. 12065)
*--
LJ Basic Formulition
LJ AkwnM«F
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Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed
copies of the form are required. Following are basic instructions:
a. All the blocks on the form must be filled in and answered completely.
b. If any block is not applicable, mark it N/A,
c. The CSF must be signed, dated and the telephone number of the responsible party
must be provided.
d. All applicable information which is on the product specific data submission must
also be reported on the CSF.
e. All weights reported under item 7 must be in pounds per gallon for liquids and
pounds per cubic feet for solids,
f. Flashpoint must be in degrees Fahrenheit and flame extension in inches,
g. For all active ingredients, the EPA Registration Numbers for the currently
registered source products must be reported under column 12.
h. The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all
common names for the trade names must be reported.
i. For the active ingredients, the percent purity of the source products must be
reported under column 10 and must be exactly the same as on the source
product's label,
j. All the weights in columns 13.a. and 13,b. must be in pounds, kilograms, or
grams. In no case will volumes be accepted. Do not mix English and metric
system units (i.e., pounds and kilograms).
k. All the items under column 13.b. must total 100 percent,
1. All items under columns 14,a. and 14.b. for the active ingredients must represent
pure active form.
m. The upper and lower certified limits for ail active and inert ingredients must
follow the 40 CFR 158,175 instructions. An explanation must be provided if the
proposed limits are different than standard certified limits.
n. When new CSFs are submitted and approved, all previously submitted CSFs
become obsolete for that specific formulation,
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130
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r/EPA
United states Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form
OMB No. 207 ant
Product >HIHC
CampgitT Number
V.V\ Kf$. \o.
I Certify that:
My company is witling to develop and submit the data required by EPA under the authority of the Federal
insecticide, Fungicide and Rodsnticide Act (F1FRA), if necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data.
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3{c}(2)(B){i5} of FEFRA 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):
N»m» of Firm(»J
Dmi* of Offer
Certification:
I certify that 1 am duly authorized to represent the company named above, and that the statements that I have made on
this form and aS attachments therein are true, accurate, and complete, i acknowledge that any knowingly false or
misleading statement may be punishable by fme or imprisonment or both under applicable law.
Sign itur* of Comp*ny'» Authorized R*pr*»«nteriv*
Oil*
N»m« and Tlt|* (Pi«»« Typ« or Print)
EPA Form 8570-32 (S/»I) RrpiacM EPA Form 8580. which is u
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United StitM Environmental Prottetlon Agtncy **„ ******
£\ ^l'*^l% JV Washington, DC 20480
^fffcHn-A CERTIFICATION WITH RESPECT TO "" ""• SK£
^^ ••» * » DATA COMPENSATION REQUIREMENTS *w»*»«i •**•• "'*
PubOc reporting burden for this eeltetion at intoimatbn if estimated to avenge 15 minutes per response. includinQ
time for reviewing instructions, starching existing data sources, gainering and maeitaining th« data needed, and
completing and reviewing tht coNtctfen of Information. Send eommenu rvgarttingttw burden etdmate or any oinw
aspect of this collection of informaUon, incWing suggestions tor reducing this burden, to CMet. information Poficy
Brancn, PM-223, U.S. Environmental Protection Agency. 401 M St., S.W., Washington, DC 20460; and to the Office
of M*rugem«r« and Budget, Pap*rwoffc Reduction Project {£070-0106), Washington, DC 20503.
Pfeate flit In blanka below.
Ctfifint N»i»«
'rodnct !!•••
iCertttytnar.
1 , For each fiudy cited ki support g< regtstratien or reregisirnion under the Federal Ir
Rodenticide Aa (FIFHA) that * an encash* use study J am the original data subml1
written permission of the original data submitter 10 cite that study.
2. That tor each study died in support of registration or reregistratbn under F1FRA tha
study. 1 am the original data subminer, or 1 have obtained the wrftten permission of H
have notified in writing the ownpanyOes) Jhat submited data J have died and have*
compensation tor those data In accordance wKh sections 3(c)n)(0) and 3{c){2)<0) o
[] The companies who have submitted the studies Ssted on tht back«»WilOffl'
sheets, or ineftcaietf on the attached "Requirements Status and Registrants' F
registration or reregislraiion under F1FRA.
Siyrmiun;
HUM M* nil* (PIMM Tv»e er MM)
ucNenni. or p tn TO FAY! I nefsay oner ana agree 10 pay oompenswon w wner pi
regtstraiiOfi or reregistraion of niy pfooucts, to tne extent requtfefl &y rirnA sections .
1 SiRnatarc
f
Hwm Mid Tlita (M«M« TfM *r Mftl)
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