Attachment F - PR Notice 86-5

Pesticide Registration (PR) Notice 86-5,Standard Format for Data Submitte...IFRA and Certain Provisions of the FFDCA | Regulating Pesticides | US EPA

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Pesticide Registration (PR) Notice 86-5

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Reevaluation: Pesticide
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Pesticide Registration (PR) Notice 86-5:
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)

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July 29, 1986

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Pesticide Registration Notices

Notice To: Producers, Formulators,
Distributors And Registrants
Attention: Persons Responsible for Federal Registration of Pesticides

Storage & Disposal
Restricted & Canceled
Uses
Pesticide Tolerances
Registration
Information Sources

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 (EUPs), tolerances, and related
approvals under certain provisions of FIFRA and FFDCA. These data are
defined in FIFRA section 10(d)(1). This Notice does not apply to
commercial, financial, or production information, which are, and must

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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 (Section 158.32 of Title 40 of the Code of Federal
Regulations [40 CFR 158.32]), and Procedures for Claims of
Confidentiality of Data (40 CFR 158.33). These regulations specify
the format for data submitted to EPA under FIFRA section 3 and FFDCA
sections 408 and 409, and procedures which must be followed to make
and substantiate claims of confidentiality. No entitlements to data
confidentiality are changed, either by the proposed regulation or by
this Notice.
The Office of Pesticide Programs (OPP) is making these
requirements mandatory through this Notice to gain resource-saving
benefits from their use before the entire proposed regulation becomes
final. Adequate lead time is being provided for submitters to comply
with the new requirements.
V. RELATIONSHIP OF THIS NOTICE TO OTHER OPP POLICY AND GUIDANCE
While this Notice contains requirements for organizing and
formatting submittals of supporting data, it does not address the
substance of test reports themselves. "Data reporting" guidance is
now under development in OPP, and will specify how the study objectives,
protocol, observations, findings, and conclusions are organized and
presented within the study report. The data reporting guidance will be
compatible with submittal format requirements described in this Notice.

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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 section 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.
(The original PR Notice 86-5 had a paragraph about submitting extra
copies of studies for the public docket. This practice is no longer
followed.)
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 below, 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.
INDEX Example
A. Organization of Submittal Package Attachment 7
B. Transmittal Document Attachment 1
C. Individual Studies

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C.1. Special Considerations for Identifying Studies
D. Organization of Each Study Volume Attachment 7
D.1. Study Title Page Attachment 2
D.2. Statement of Data Confidentiality Claims Attachment 3
[Based on FIFRA section 10(d)(1)]
D.3. Confidential Attachment Attachment 5
D.4. Supplemental Statement of Data
Confidentiality Claims [Other
Than Those Based on FIFRA section
10(d)(1)] Attachment 4
D.5. Good Laboratory Practice Compliance Statement Attachment 6
E. Reference to Previously Submitted Data
F. Physical Format Requirements and Number of Copies
G. Special Requirements for Submitting Data to the Docket
(NOW OBSOLETE)
------------------------------------------------------------------------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 administrative 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

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are intended to clarify, emphasize, or otherwise comment to help
Product Managers and reviewers better understand the submittal.
- If such materials relate to one study, they should be
included as an appendix to that study.
- If such materials relate to more than one study (as
for example a summary of all studies in a discipline)
or to the submittal in general, they must be included
in the submittal package as a separate study (with
title page and statement of confidentiality claims).
B. Transmittal Document
The first item in each submittal package must be a transmittal
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, EUP,
section 3(c)(2)(B) Data Call-In Notice, section 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 Guidelines 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 Part 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.
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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 completeness.
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 Guideline requirement for
supporting data, with some exceptions discussed in section C.1. Each
study included in a submittal package must be bound as a separate
entity. (See comments on binding studies in section F.)
Each study must be consecutively paginated, beginning from the
title page as page 1. The total number of pages in the complete study
must be shown on the study title page. In addition (to ensure that
inadvertently separated pages can be reassociated with the proper
study during handling or review) use either of the following:
- Include the total number of pages in the complete
study on each page (i.e., 1 of 250, 2 of 250, ...250 of 250).
- Include a company name or mark and study number on
each page of the study, e.g., Company Name-1986-23.
Never reuse a study number for marking the pages of
subsequent studies.
When a single study is extremely long, binding it in
multiple volumes is permissible so long as the entire study is
paginated 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
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other reasons.
a. Safety Studies. Several Guidelines require testing for
safety in more than one species. In these cases, each species tested
should be reported as a separate study, and bound separately.
Extensive supplemental reports of pathology reviews, feed analyses,
historical control data, and the like are often associated with safety
studies. Whenever possible these should be submitted with primary
reports of the study, and bound with the primary study as appendices.
When such supplemental reports are submitted independently of the
primary report, take care to fully identify the primary report to which
they pertain.
Batteries of acute toxicity tests, performed on the same end-use
product and covered by a single title page, may be bound together and
reported as a single study.
b. Product Chemistry Studies. All product chemistry data
within a submittal package submitted in support of an end-use
product produced from registered manufacturing-use products should be
bound as a single study under a single title page.
Product chemistry data submitted in support of a technical
product, other manufacturing-use product, an EUP, 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 157-13, 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

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contain Confidential Business Information (CBI) as defined in FIFRA
section 10(d)(1)(A), (B), or (C), and if so must be handled as
described in section D.3. of this Notice.
c. Residue Chemistry Studies. Guidelines 171-4, 153-3, and 153-4
are extremely broad in scope; studies addressing residue chemistry
requirements must thus be defined at a level below that of the Guideline
code. The general principle, however, of limiting a study to the report
of a single investigation 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. (See Attachment 7.) 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 When Required Example
Study Title Page Always Attachment 2
Statement of Data One of the two alternative Attachment 3
Confidentiality forms of this statement
Claims is always required.
Certification of Good If study reports laboratory Attachment 6
Laboratory Practice work subject to GLP
(GLP) requirements.
Flagging Statements For certain toxicology

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studies. (When flagging
requirements are finalized.)
Body of Study Always - with an English
language translation if
required.

Study Appendices At submitter's option
Cover Sheet to Confi- If CBI is claimed under
dential Attachment FIFRA section 10(d)(1)(A),
(B), or (C)
CBI Attachment If CBI is claimed under Attachment 5
FIFRA section 10(d)(1)(A),
(B), or (C)
Supplemental Statement Only if confidentiality is Attachment 4
of Data Confidentiality claimed on a basis other
Claims than FIFRA section
10(d)(1)(A), (B), or (C)
D.1. 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 Attachment 2
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.

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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. Supplemental Submissions. If the study is a commentary on or
supplement to another previously submitted study, or if it responds to
EPA questions raised with respect to an earlier study, include on the
title page elements a. through d. for the previously submitted study,
along with the EPA Master Record Identifier (MRID) or Accession Number
of the earlier study if you know these numbers. (Supplements submitted
in the same submittal package as the primary study should be appended to
and bound with the primary study. Do not include supplements to more
than one study under a single title page.)
g. Facts of Publication. If the study is a reprint of a published
document, identify on the title page all relevant facts of publication,
such as the journal title, volume, issue, inclusive page numbers, and
publication date.
D.2. Statements of Data Confidentiality Claims Under FIFRA
section 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 sections 158.33(b) and (c) (see
Attachment 3). These statements apply only to claims of data
confidentiality based on FIFRA section 10(d)(1)(A), (B), or (C). Use
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the appropriate alternative form of the statement either to assert a
claim of section 10(d)(1) data confidentiality (section 158.33(b)) or
waive such a claim (section 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 petitions for tolerances or emergency
exemptions (see NOTE at bottom of Attachment 3).
D.3. Confidential Attachment
If the claim is made that a study includes confidential business
information as defined by the criteria of FIFRA section 10(d)(1)(A),
(B), or (C) (as described in D.2. above), all such information must be
excised from the body of the study and confined to a separate
study-specific Confidential Attachment. Each passage of CBI so isolated
must be identified by a reference number cited within the body of the
study at the point from which the passage was excised (see Attachment 5).
The Confidential Attachment to a study must be identified by a
cover sheet fully identifying the parent study, and must be clearly
marked "Confidential Attachment." An appropriately annotated
photocopy of the parent study title page may be used as this cover
sheet. Paginate the Confidential Attachment separately from the body of
the study, beginning with page 1 of X on the title page. Each passage
confined 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 section 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 section
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

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subject to a claim of confidentiality.
- A Supplemental Statement of Data Confidentiality
Claims must be submitted, identifying each passage
claimed confidential 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.
- The Supplemental Statement of Data Confidentiality
Claims must be signed and dated and must include the
typed name and title of the official who signed it.
D.5. Good Laboratory Practice Compliance Statement
This statement is required if the study contains laboratory
work subject to GLP requirements specified in 40 CFR Part 160.
Samples of these statements are shown in Attachment 6.
E. Reference to Previously Submitted Data
DO NOT RESUBMIT A STUDY THAT HAS PREVIOUSLY BEEN SUBMITTED FOR
ANOTHER PURPOSE unless EPA specifically requests it. A copy of the
title page plus the MRID Number (if known) is sufficient to allow us to
retrieve the study immediately for review. This prevents duplicate
entries in the Agency files, and saves you the cost of sending more
copies of the study. References to previously submitted studies should
not be included in the transmittal document, but should be incorporated
into the statement of the method of support for the application.
F. Physical Format Requirements
All elements in the data submittal package must be on uniform
8 1/2 by 11 inch white paper, printed on one side only in black ink,
with high contrast and good resolution. Bindings for 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:

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o Do not include frayed or torn pages.
o Do not include carbon copies, or copies in other than
black ink.
o Make sure that photocopies are clear, complete, and fully
readable.
o Do not include oversize computer printouts or
fold-out pages.
o Do not bind any documents with glue or binding tapes.

o 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 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.)
G. Special Requirements for Submitting Data to the Docket
(NOW OBSOLETE)
Data submittal packages associated with a Registration Standard or
Special Review were originally required in four copies in order to
include a copy for the Docket. This practice has been discontinued.
Only three copies of a study are now required.

V. FOR FURTHER INFORMATION
For further information, contact Kathryn S. Bouve, Chief,
Information Services Branch, Program Management and Support Division, at
(703) 305-5032. [Address Updated 1/8/97]

original signer: James W. Akerman
Acting Director

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Registration Division

Attachment 1. Sample Transmittal Document
Attachment 2. Sample Title Page for a Newly Submitted Study
Attachment 3. Statements of Data Confidentiality Claims
Attachment 4. Supplemental Statement of Data Confidentiality Claims
Attachment 5. Samples of Confidential Attachments
Attachment 6. Sample of Good Laboratory Practice Statements
Attachment 7. Format Diagrams for Submittal Packages and Studies

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 Boulevard
Cincinnati, OH 98765 Covington, KY 56789
+Smith Chemical Corporation will act as sole agent for all
submitters.
2. Regulatory Action in Support of Which This Package is Submitted
Use the EPA identification Number (e.g., 359-EUP-67) if you know
it. Otherwise describe the type of request (e.g., experimental
use permit, data call-in notice - of xx-xx-xx date).
3. Transmittal Data
4. List of Submitted Studies
Vol 1. Administrative materials - forms, previous correspondence
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 transmittal
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

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Company Name:
________________________________________________
Company Contact: ____________________________
__________________
Name Phone

ATTACHMENT 2
SAMPLE STUDY TITLE PAGE FOR A NEWLY SUBMITTED STUDY
Study Title
(Chemical Name) - Magnitude of Residue on Corn
Data Requirement
Guidelines Reference No. 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)

ATTACHMENT 3
STATEMENTS OF DATA CONFIDENTIALITY CLAIMS
1. No claim of confidentiality under FIFRA section 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 section 10(d)(1)(A), (B), or (C).
Company: ____________________________________________________

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Company Agent: Typed Name Date:
-------------------------- ------------Title Signature
----------------------------------------- ------------------2. Claim of confidentiality under FIFRA section 10(d)(1)(A), (B), or
(C).
Information claimed confidential on the basis of its falling
within the scope of FIFRA section 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, 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.

ATTACHMENT 4
SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
For any portion of a submitted study that is not described by FIFRA
section 10(d)(1)(A), (B), or (C), but for which you claim confidential
treatment on another basis, the following information must be included
within a Supplemental Statement of Data Confidentiality Claims:
o Identify specifically by page and line number(s) each portion of
the study for which you claim confidentiality.
o Cite the reasons why the cited passage qualifies for
confidential treatment.
o Indicate the length of time--until a specific date or event, or
permanently--for which the information should be treated as
confidential.
o Identify the measures taken to guard against undesired
disclosure of this information.
o Describe the extent to which the information has been disclosed,
and what precautions have been taken in connection with those
disclosures.
o Enclose copies of any pertinent determinations of
confidentiality made by EPA, other Federal agencies, or courts
concerning this information.
o 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.

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o If you assert that the information is voluntarily submitted,
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.

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: Ethylene Glycol
PAGE LINE REASON FOR THE DELETION FIFRA REFERENCE
6 14 Identity of Inert Ingredient section 10(d)(1)(C)
28 25 " "
100 19 " "
----------------------------------------------------------------------Example 2 (Confidential paragraph(s) that have been deleted from the
study)
CROSS REFERENCE NUMBER 5 This cross-reference number is
used in the study in place of the
following paragraph(s) at the
indicated volume and page references.
DELETED PARAGRAPH(S):
()
( Reproduce the deleted paragraph(s) here )
()
PAGE LINE REASON FOR THE DELETION FIFRA REFERENCE
20 4-17 Description of the quality section 10(d)(1)(C)
control process
----------------------------------------------------------------------Example 3 (Confidential pages that have been deleted from the study)
CROSS REFERENCE NUMBER 7 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(S) REASON FOR THE DELETION FIFRA REFERENCE
33-41 Description of product section 10(d)(1)(A)
manufacturing processing

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ATTACHMENT 6
SAMPLE GOOD LABORATORY PRACTICE STATEMENTS
Example 1.
This study meets the requirements for 40 CFR Part 160
Submitter: _____________________________________________
Sponsor: _____________________________________________
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. _____________________________________________________
Submitter: ______________________________________________
Sponsor: ______________________________________________
Study Director: _________________________________________
Example 3.
The submitter of this study was neither the sponsor of this study nor
conducted it, and does not know whether it has been conducted in
accordance with 40 CFR Part 160.
Submitter: ______________________________________________

ATTACHMENT 7
FORMAT OF THE SUBMITTAL PACKAGE
A. Transmittal Document.
B. Related Administrative Materials
(e.g., Method of Support Statement, etc.).
C. Other materials about the submittal
(e.g., summaries of groups of studies to aid
in their review).
D. Studies, submitted as unique physical
entities, according to the format below.
--------------------------------FORMAT OF SUBMITTED STUDIES
A.* Study title page.
B.* Statement of Confidentiality Claims.
C.* GLP and flagging statements - as appropriate.

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D.* Body of the study, with English language translation
if required.
E.** Appendices to the study.
F.** Title Page of the Confidential Attachment.
G.** Confidential Attachment.
H.** Supplemental Statement of Confidentiality
Claims.
LEGEND
* Documents which must be submitted as appropriate to meet
established requirements.
** Documents submitted at submitter's option.

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