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Pesticide Registration (PR) Notice 86-5 

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)

Resources

● Pesticide Registration Notices

July 29, 1986

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 (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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