US Environmental Protection Agency 

Office of Pesticide Programs 

�� Pesticide Registration (PR) Notice 2011-3 

 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)

� 

 November 30, 2011
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Pesticide Registration (PR) Notice 2011-3
 

Notice To: Manufacturers, Producers, Formulators, Distributors and Registrants 

Attention: Persons Responsible for Federal Registration of Pesticides Products 

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 AND APPLICABILITY 

This PR Notice updates and replaces Pesticide Registration Notice 86-5 and discusses both the 

recommended and the required procedures for submitting FIFRA and FFDCA data. All required 

procedures contained within this document, generally indicated by use of the word “must,” were 

previously made mandatory by statute or regulation; this document creates no new legally 

binding requirements. Where indicated by the use of non-mandatory language such as “may,” 

“should” and “can,” this document provides recommendations or guidance. 

The PR Notice applies to all data that are submitted to EPA to support any application, petition, 

or submission intended to persuade EPA to grant, modify or leave unmodified a registration or 

other approval required as a condition of sale or distribution of a pesticide. Such submissions 

may include, but are not limited to, the following: an application for registration or amended 

registration of a pesticide product under FIFRA section 3 or 24; a submission of data required in 

conjunction with reregistration of a currently registered product under FIFRA section 4 (or its 

registration review under FIFRA section 3); an application for an experimental use permit under 

FIFRA section 5; a submission of data in response to a notice issued by EPA under FIFRA 

section 3(c)(2)(B); a petition to establish or modify a tolerance or an exemption from the 

requirement of a tolerance for a pesticide chemical residue under FFDCA section 408 as well as 

studies submitted under FIFRA section 6(a)(2). (See generally, 40 CFR parts 150 – 189; 

specifically, 40 CFR parts 158, 160, 161 and 174.) 

II. EFFECTIVE DATE 

Effective immediately. 

III. BACKGROUND 

PR Notice 86-5 has served as the Office of Pesticide Programs’ (OPP’s) data formatting 

guidance since its publication on July 29, 1986. At the time PR Notice 86-5 was originally 

issued, the only acceptable medium for data submission was paper. Today, advances in 

information technology, statutory and regulatory changes, and new policy initiatives make this 

an opportune time to update the guidance. This new guidance gives registrants the option of 

submitting electronic submissions and provides a flexible but still acceptable format for data 

submission, regardless of the medium in which the data are submitted. Attachment 5 contains a 

listing of glossary terms used in this guidance. 

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IV. OVERVIEW OF CHANGES 

The following list is a summary of the changes recommended by this guidance. A more detailed 

description of the changes to the guidance is described in sections IV and V. 

Electronic submission on CD or DVD is now an option for some types of data 

submissions. OPP plans to make this option available to more types of submissions. 

Check the e-Submission website 

(http://www.epa.gov/pesticides/regulating/registering/submissions/index.htm) for the 

latest information. 

Since the inception of PR Notice 86-5, Master Record Identifiers (MRIDs) have been 

assigned only to data documents that comply with its formatting instructions. One 

major process change being planned by OPP is that MRIDs will no longer be 

assigned after these documents have been screened. MRIDs are already being preassigned, in the case of electronic submissions. Similarly, MRIDs will be assigned to 

all of the data documents in a paper submission prior to our format screening process. 

Submitters will continue to be notified if a document does not meet the mandatory 

formatting elements. 

Currently, three identical copies of all applicable data are required. This applies to 

submissions that are entirely paper. Please note that as OPP phases in its up-front 

imaging of paper submissions, we expect to reduce this requirement to a single copy. 

For the latest information on the status of the up-front imaging effort and number of 

copies required please continue to check the e-Submission website 

(http://www.epa.gov/pesticides/regulating/registering/submissions/index.htm). 

Previous language discouraging double-sided printing and color printing has been 

eliminated. 

Section G of PRN 86-5, Special Requirements for Submitting Data to the Docket, is 

obsolete and has been eliminated. 

Information on asserting claims of data confidentiality has been updated in 

accordance with the latest edition of 40 CFR sections158, 161 and 174. 

The information on flagging of studies for potential adverse effects has been updated 

in accordance with the latest edition of 40 CFR sections 158 and 161. 

OECD dossier format is an option that did not exist when PRN 86-5 was written. 

References to the data requirements for antimicrobial pesticides, which have been 

redesignated in new 40 CFR 161, have been inserted as appropriate. 

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V.	 RELATIONSHIP OF THIS NOTICE TO OTHER OPP POLICY AND GUIDANCE 

FOR SUBMITTING DATA 

A. Test reports and study profile templates 

This notice contains guidance for organizing and formatting submissions of supporting data but 

does not address the substance of test reports themselves. Consult the OPP website at 

http://www.epa.gov/pesticides/regulating/studyprofile templates/studyprofile templatelist.htm 

for information on study profile templates and at 

http://www.epa.gov/ocspp/pubs/frs/home/guidelin.htm for information on harmonized test 

guidelines. 

B. Adverse effects reporting 

Detailed guidance on adverse effects reporting under FIFRA section 6(a)(2) is available at 

http://www.epa.gov/pesticides/fifra6a2/. 

C. Electronic submissions 

At this writing, electronic submission on CD or DVD is an option for some, but not all, types of 

data submissions. Electronic submission guidance is available on OPP’s website at

http://www.epa.gov/pesticides/regulating/registering/submissions/index.htm. However, OPP 

continues to accept all types of data submissions in paper form. 

D. OECD dossier format 

There is an alternative to the overall submission format presented in this Notice for submitters 

who are planning a multi-national electronic submission on CD or DVD. Information on the 

OECD dossier format can be found at http://www.oecd.org. Submitters who use this format 

should arrange individual documents as described in this Notice, with the exception of the 

placement of any information claimed as confidential. Instead of preparing a confidential 

attachment for an individual document, all confidential information should be compiled in 

Document J of the dossier. 

E. Technical amendments for antimicrobial pesticides, 40 CFR part 161 

EPA has redesignated certain pesticide data requirements formerly located in 40 CFR 158 into a 

new part 161. The data requirements that have been transferred apply to antimicrobial 

pesticides. EPA has made conforming changes and cross-reference revisions to the redesignated material, including re-designation of 40 CFR part 158.32, 158.33, and 158.34 as 

161.32, 161.33 and 161.34, respectively. These technical amendments, published in the Federal 

Register on October 24, 2007, (72 FR 60251) preserve the original data requirements for use 

with antimicrobial pesticides until such time as a final rule for antimicrobial pesticides can be 

promulgated and made effective. 

F. Clarification of plant-incorporated protectants data submissions 

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The characteristics of plant-incorporated protectants (PIPs), such as their production and use in 

plants, their biological properties, and their ability to spread and increase in quantity in the 

environment, distinguish them from traditional chemical pesticides. Therefore, PIPs are subject 

to different regulatory requirements and procedures than traditional chemical pesticides. 40 CFR 

174 sets forth regulatory requirements, criteria, and procedures applicable to PIPs under FIFRA 

and FFDCA. When applied to PIPs, the definitions and regulations in 40 CFR 174 supersede the 

regulations found in 40 CFR parts 150 through 180 to the extent that the regulations conflict. 

VI. FORMAT 

A submission consists of all the documents sent to OPP at the same time in support of a single 

regulatory action or a group of related actions, such as a product amendment and a related 

tolerance petition. The documents should be accompanied by a transmittal document and related 

administrative material (e.g., EPA Forms 8570-1, 8570-4, etc.) as appropriate. For actions 

subject to a registration service fee (see FIFRA section 33), failure to comply with this guidance 

may result in rejection of the action during the 21-day completeness screening. This transmittal 

document and administrative material should be grouped together in the first physical volume if 

the submission is on paper. Consult the e-submission XML guidance document at 

http://www.epa.gov/pesticides/regulating/registering/submissions/XMLsubmissions/esubmission xml guidance document v1.pdf for specific information on the format of these 

documents as files on a CD/DVD. 

A detailed discussion of format elements appears below and samples of some of the elements are 

attached. Except for the language of the two alternative forms of the Statement of Data 

Confidentiality that can not be altered (see 40 CFR 158.33), these samples are illustrative. As 

long as the required information is included and clearly identifiable, then the form of the samples 

may be altered to reflect the submitter’s preference.

A. Organization of the data submission package 

The following physical format guidance applies to the transmittal document and data documents 

in a paper data submission. Consistency of electronic data submissions with the data 

submission requirements cited in this notice will be verified electronically. 

8.5 x 11-inch white paper 

High contrast and good resolution 

Easily removable bindings* 

Pages in good condition 

No fold-out or oversize pages 

All pages present, consecutively paginated and in the correct order 

Double-sided printing acceptable, color printing acceptable 

*Two examples of adequate binding are: 1) a staple in the upper-left corner of a small document 

or 2) plastic covers held together by two metal prongs. Transparent covers are preferred. Threering binders are discouraged. 

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B. Transmittal Document (Sample provided in Attachment 1) 

The transmittal document is the first item in each submission. This document discusses basic 

information-- i.e., who is submitting the information, what regulatory actions are involved, the 

date of transmittal, a list of documents in the package and the contact information. Specifically, 

this document identifies: 

the submitting company’s name and address, its EPA-assigned company number(s) if 

one has been previously assigned, and contact information, preferably including fax 

number and email address in addition to name and phone number and the regulatory 

or other action(s) identified by EPA-assigned number (such as the EPA registration 

number, case number or decision number) in support of which the package is being 

submitted. If no number has been assigned by EPA, describe the type of request: data 

call-in notice of MM/DD/YY, experimental use permit, etc.; 

the transmittal date; and 

a list of all documents included in the package in the order of their appearance. They 

should be grouped by discipline (e.g., product chemistry, toxicology, environmental 

fate) and arranged in ascending order by guideline number within each discipline. 

Submitters commonly provide this information in a cover letter. This is adequate so long as all 

of the elements above are included. 

C. Individual documents 

A data document is most commonly the report of a single scientific investigation including all 

supporting analyses required for logical completeness. It may also be a compilation of product 

chemistry data, a summary document that relates to two or more other documents in the 

submission, a rationale for a data waiver request, or any other document that addresses a data 

requirement. If a study is a commentary on or supplement to another previously submitted 

document, or if it responds to EPA questions raised with respect to an earlier document, then 

submitters should include on the title page the EPA MRID of the earlier document, if known. 

Previously submitted documents should not be resubmitted unless specifically requested by OPP. 

Each document should be consecutively paginated beginning with the title page and continuing 

throughout the document, including any appendices. If it is extremely long, binding in multiple 

volumes may be necessary. In this case, the pagination should continue consecutively through 

all of the physical volumes. Each physical volume should be plainly identified by its title and its 

position in the multi-volume sequence (e.g., volume 1 of N, 2 of N, etc.). An English translation 

must be provided for any information in another language, as specified in 40 CFR 158.32(c)(4). 

Currently, three identical copies of all applicable data are required. This applies to submissions 

that are entirely paper. Please note that as OPP phases in its up-front imaging of paper 

submissions, we expect to reduce this requirement to a single copy. For the latest information on 

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the status of the up-front imaging effort and number of copies required, please continue to check 

the e-Submission website 

(http://www.epa.gov/pesticides/regulating/registering/submissions/index.htm). 

1. Document Title Page (Sample provided in Attachment 2) 

Contains the following information for unpublished documents*: 

Document title. This should be as descriptive as possible and include the substance(s) 

or product tested.
 

Test guideline(s) http://www.epa.gov/oppts/pubs/frs/home/guidelin.htm
 

Author(s). Submitters should cite only individuals with primary intellectual
 

responsibility for the content of the document.
 

Study completion date, if applicable; otherwise submitters should use the date on
 

which the document was created.
 

Performing laboratory(ies). If the document reports work done by one or more labs,
 

submitters should include on the title page the name and address of the performing
 

lab(s) and the lab’s internal project number(s) for the work
 

Laboratory project identifier. Submitters should clearly distinguish between the lab’s
 

project identifier and any other reference numbers provided by the sponsor or 

submitter.
 

Total page count for the document (Page 1 of xx).
 

*Published documents should be identified by the relevant facts of publication, such as journal
 

title, volume, issue, page range and publication date.
 

2. Statement of Confidentiality Claim 

The regulations that address data confidentiality requirements are specific to the three categories 

below. The first category represents the majority of documents submitted to the Office of 

Pesticide Programs. 

All pesticides other than antimicrobial pesticides and plant-incorporated protectants,
 

Antimicrobial pesticides, and
 

Plant-incorporated protectants (PIPs).
 

A.	 Documents supporting all pesticides other than antimicrobial pesticides and plantincorporated protectants (See 40 CFR 158.33): 

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One of the two statements below must appear on the second page of each data document. The 

wording of these statements is prescribed by 40 CFR 158.33. Neither deviations from the text of 

these two statements nor claims or markings on the document or its attachments other than the 

statement provided on page 2 of the document will be recognized as asserting a claim of 

confidentiality. The statement must be signed and dated by an authorized representative of the 

submitter. 

1) NO CLAIM OF CONFIDENTIALITY 

No claim of confidentiality, on any basis whatsoever, is made for any information 

contained in this document. I acknowledge that information not designated as 

within the scope of FIFRA sec. 10(d)(1)(A), (B), or (C) and which pertains to a 

registered or previously registered pesticide is not entitled to confidential treatment 

and may be released to the public, subject to the provisions regarding disclosure to 

multinational entities under FIFRA 10(g). 

Submitter: _______signature_________ Date: __________
 

Typed Name of Signer: ______________________________
 

Typed Name of Company: ___________________________
 

2) CLAIM OF CONFIDENTIALITY 

Information claimed as confidential has been removed to a confidential attachment. 

Submitter: _______signature_________ Date: __________
 

Typed Name of Signer: ______________________________
 

Typed Name of Company: ___________________________
 

Use of the statement above requires that all information claimed as confidential be submitted in a 

separate confidential attachment to the document and cross referenced to the specific location 

from which it was removed. The confidential attachment must have its own title page and be 

paginated separately from the non-confidential document. 

In the confidential attachment, information claimed confidential under FIFRA 10(d)(1)(A), (B) 

and (C) must be individually identified. 

FIFRA 10(d)(1)(A): Information that consists of (or whose disclosure would in turn 

disclose) manufacturing or quality control processes. 

FIFRA 10(d)(1)(B): Information that consists of (or whose disclosure would in turn 

disclose) the details of any methods for testing, detecting, or measuring the quantity of 

any deliberately added inert ingredient of a pesticide. 

FIFRA 10(d)(1)(C): Information that consists of (or whose disclosure would in turn 

disclose) the identity or percentage quantity of any deliberately added inert ingredient of 

a pesticide. 

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Sample cross references between the non-confidential document and its confidential attachment 

are provided in Attachment 3. 

3) VOLUNTARY RELEASE OF INFORMATION TO STATES AND FOREIGN 

GOVERNMENTS (40 CFR 158.33(c)(4)) 

In addition to the required use of one of the two confidentiality statements above, submitters are 

encouraged to include an additional statement to allow EPA to share information with state and 

foreign governments to facilitate coordination of pesticide reviews. EPA will not consider such 

a statement to be a waiver of confidentiality or proprietary claims for the information. The 

statement is as follows: 

I authorize the Environmental Protection Agency to release any information 

contained in this document to State and foreign governments, without relinquishing 

proprietary rights or any confidentiality claims asserted above. 

Submitter: _______signature_________ Date: __________
 

Typed Name of Signer: ______________________________
 

Typed Name of Company: ___________________________
 

Information designated as releasable to state or foreign governments in accordance with the 

above statement may be released to those governments without further notice to the submitter. 

EPA will inform the state or foreign government of any confidentiality claims associated with 

the information. 

B. Documents supporting antimicrobial pesticides (See 40 CFR 161.33): 

40 CFR 161.33 is the regulation that currently governs the procedures for claims of 

confidentiality of data in antimicrobial pesticide documents. One of the two statements below 

must appear on the second page of each data document. The statement must be signed and dated 

by an authorized representative of the submitter. 

1) NO CLAIM OF CONFIDENTIALITY 

If no claim of confidentiality is being made for information described by FIFRA section 

10(d)(1)(A), (B), (C), or if such information is not contained in the body of the study, the 

Statement of Data Confidentiality Claims must include the following statement. This 

statement must bear the name, title and signature of the submitter or his properly 

designated agent, and the date of signature: 

No claim of confidentiality is made for any information contained in this study on 

the basis of its falling within the scope of FIFRA sec. 10(d)(1)(A), (B), or (C). 

Submitter: _______signature_________ Date: __________ 

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Typed Name of Signer: ______________________________
 

Typed Name of Company: ___________________________
 

2) CLAIM OF CONFIDENTIALITY 

Any information claimed to be confidential under FIFRA 10(d)(1)(A) through (C) must 

be contained in a separate attachment to the study. If any information is included in the 

body of the study rather than in the confidential attachment, the submitter waives a claim 

of confidentiality for such information under FIFRA section 10(d)(1)(A), (B) or (C). The 

attachment must have a cover page that is clearly marked to indicate that the material 

contained in the attachment falls within the scope of FIFRA section 10(d)(1)(A), (B) or 

(C). Each item in the attachment must be numbered. For each item, the submitter must 

cite the applicable portion of FIFRA section 10(d)(1)(A), (B) or (C) on which the claim 

of confidentiality is based. In addition, for each item, the submitter must provide a list of 

page numbers in the study where the item is cited (i.e., identified by number). Each item 

in the attachment must be referenced in the body of the study by its number in the 

attachment. 

The following statement must appear on the Statement of Data Confidentiality Claims and must 

bear the name, title, and signature of the submitter or his properly designated agent, and the date 

of signature: 

Information claimed as confidential on the basis of its falling within the scope of 

FIFRA sec. 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. 

Submitter: _______signature_________ Date: __________
 

Typed Name of Signer: ______________________________
 

Typed Name of Company: ___________________________
 

Sample cross references between the non-confidential document and its confidential attachment 

are provided in Attachment 3. 

Any information not described by FIFRA section 10(d)(1)(A), (B), or (C) for which a claim of 

confidentiality is made must be submitted in accordance with the following procedures: 

The information must be clearly marked in the body of the study as being claimed 

confidential. 

A separate Supplemental Statement of Data Confidentiality Claims must be submitted, 

identifying by page and line number the location within the study of each item claimed 

confidential, and stating the basis for the claim. 

The Supplemental Statement of Data Confidentiality Claims must bear the name, title 

and signature of the submitter or his properly designated agent, and the date of 

signature. 

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C. Documents supporting plant-incorporated protectants (PIPS) (See 40 CFR 174.9): 

Although it is strongly recommended that the submitter minimize the amount of data and other 

information claimed as Confidential Business Information, a submitter may assert a claim of 

confidentiality for all or part of the information submitted to EPA in a submission for a plantincorporated protectant. To assert such a claim, the submitter must comply with all of the 

following procedures: 

Any claim of confidentiality must accompany the information at the time the information 

is submitted to EPA. Failure to assert a claim at that time constitutes a waiver of 

confidentiality for the information submitted, and the information may be made available 

to the public, subject to section 10(g) of FIFRA, with no further notice to the submitter. 

Any claim of confidentiality must be accompanied, at the time the claim is made, by 

comments substantiating the claim and explaining why the submitter believes that the 

information should not be disclosed. The submitter must address each of the following 

points in substantiation. EPA will consider incomplete all plant-incorporated protectant 

submissions containing information claimed as CBI that are not accompanied by 

substantiation and will suspend any applicable review of such submissions until the 

required substantiation is provided. 

1.	 The portions of the information that are alleged to be entitled to confidential 

treatment; 

2.	 The period of time for which confidential treatment is desired by the business 

(e.g., until a certain date, until the occurrence of a specified event or 

permanently); 

3.	 The purpose for which the information was furnished to EPA and the 

approximate date of submission, if known; 

4.	 Whether a business confidentiality claim accompanied the information when 

it was received by EPA; 

5.	 Measures taken by the business to guard against undesired disclosure of the 

information to others; 

6.	 The extent to which the information has been disclosed to others, and the 

precautions taken in connection therewith; 

7.	 Pertinent confidentiality determinations, if any, by EPA or other federal 

agencies, and a copy of any such determination, or reference to it, if available; 

8.	 Whether the business asserts that disclosure of the information would be 

likely to result in substantial harmful effects on the business's competitive 

position, and if so, what those harmful effects would be, why they should be 

viewed as substantial and an explanation of the causal relationship between 

disclosure and such harmful effects; and 

9.	 Whether the business asserts that the information is voluntarily submitted 

information as defined in §2.201(i), and if so, whether and why disclosure of 

the information would tend to lessen the availability to EPA of similar 

information in the future. 

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3. Statement of compliance or non-compliance with good laboratory practice (GLP) 

standards (40 CFR 160) 

Sample compliance statements are provided in Attachment 4. This statement is required only if a 

document meets the following definition of a study: 

Study means any experiment at one or more test sites, in which a test
 

substance is studied in a test system under laboratory conditions or in the
 

environment to determine or help predict its effects, metabolism, product
 

performance (efficacy studies only as required by 40 CFR 158.400 or 

161.640, as applicable), environmental and chemical fate, persistence and
 

residue, or other characteristics in humans, other living organisms, or 

media. The term “study” does not include basic exploratory studies

carried out to determine whether a test substance or a test method has any
 

potential utility. [Excerpt from 40 CFR 160.3]
 

4. Flagging of studies for potential adverse effects (See CFR 158.34 and 161.34) 

Any study of a type listed in tables 1 and 2 below must include the appropriate one of the two 

statements below, together with the signature of the authorized representative of the submitter 

and the date of signature on its fourth page. 

1) If the study does not meet or exceed criteria listed in the table: 

I have applied the criteria of 40 CFR 158.34/40 CFR 161.34 for flagging studies for 

potential adverse effects to the results of the attached study. This study neither 

meets nor exceeds any of the applicable criteria. 

Submitter: _______signature_________ Date: __________
 

Typed Name of Signer: ______________________________
 

Typed Name of Company: ___________________________
 

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2) If the study meets or exceeds criteria listed in the table: 

I have applied the criteria of 40 CFR 158.34/40 CFR161.34 for flagging studies for 

potential adverse effects to the results of the attached study. This study meets or 

exceeds the criteria numbered [insert all applicable reporting codes]. 

Submitter: _______signature_________ Date: __________ 

Typed Name of Signer: ______________________________ 

Typed Name of Company: ___________________________ 

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Table 1 - Flagging Criteria for All Pesticides other than Antimicrobials 

(See 40 CFR 158.34) 

Study Types Guideline 

No. 

Criteria: Treated animals show any of the following: Criteria 

No. 

Carcinogenicity or combined 870.4200 An incidence of neoplasms in males or females which 1 

chronic feeding study 870.4300 increases with dose (positive trend p≤ 0.05); or

A statistically significant (pairwise p≤ 0.05) increase of

any type of neoplasm in any test group, males or females at 

any does level, compare to concurrent control animals of 

the same sex; or 

2 

An increase in any type of uncommon or rare neoplasms in 

any test group, males or females animals at any dose level, 

compared to concurrent controls of the same sex; or 

3 

A decrease in the time to development of any type of 

neoplasms in any test group, males or females at any dose 

level, compared to concurrent controls of the same sex. 

4 

Prenatal developmental toxicity 870.3700 When compared to concurrent controls, treated offspring 5 

Reproduction and fertility 870.3800 show a dose-related increase in malformations, pre- or 

Developmental neurotoxicity 870.6300 post-natal deaths, or persistent functional behavioral 

changes on a litter basis in the absence of significant 

maternal toxicity at the same dose level. 

Neurotoxicity 870.6100 When compared to concurrent controls, treated animals 6 

870.6200 show a statistically or biologically significant increase in 

neuropathological lesions or persistent functional or 

behavioral changes. 

Chronic feeding 870.4100 The no observed adverse effect level (NOAEL) from one 7 

Carcinogenicity 870.4200 of these studies is less than the NOAEL currently used by 

Reproduction and fertility 870.3800 the Agency as the basis for either the acute or chronic 

Prenatal developmental toxicity 870.3700 reference dose. 

Developmental neurotoxicity 870.6300 

Acute or 90-day neurotoxicity 870.6200 

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Table 2 - Flagging Criteria for Antimicrobial Pesticides 

(See 40 CFR 161.34) 

Toxicity studies Pesticide 

assessment 

guideline 

No. 

Criteria Reporting 

code 

Oncogenicity [or combined 

oncogenicity/chronic feeding 

study] 

or 

Subchronic feeding study 

83-2 

82-1 

Treated animals show any of the following: 

An incidence of neoplasms in males or females which 

increases with dose; 

or 

A statistically significant (p≤ 0.05) incidence of any type

of neoplasm in any test group (male or female animals at 

any does level), compared to concurrent control animals of 

the same sex; 

or 

An increase in any type of uncommon or rare neoplasms in 

any test group (male or female animals at any dose level) 

compared to concurrent control animals; 

or 

A decrease in the time to development of any type of 

neoplasms in any test group (male or female animals at any 

dose level) compared to concurrent control animals 

1 

2 

3 

4 

Teratogenicity 83-3 When compared with concurrent controls, treated animals 

show a dose-related increase in malformations (or deaths) 

on a litter basis in the absence of significant maternal 

toxicity at the same dose levels. 

5 

Neurotoxicity 81-7 When compared with controls, treated animals show a 

response indicative of acute delayed neurotoxicity 

6 

Chronic feeding study or 

combined chronic 

feeding/oncogenicity study 

83-1 Cholinesterase inhibition NOEL less than 10 times the 

current existing ADI. 

or 

General (systemic) toxicity NOEL less than 100 times the 

current existing ADI. 

7 

8 

Reproduction study 83-4 Reproductive effects NOEL less than 100 times the current 

ADI 

9 

Subchronic feeding study 82-1 Cholinesterase inhibition NOEL less than 100 times the 

current ADI. 

or 

General (systemic) toxicity NOEL less than 1000 times the 

current existing ADI. 

10 

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ATTACHMENT 1 

SAMPLE TRANSMITTAL DOCUMENT 

Submitter: 

Smith Chemical Corp.
 

1234 West Smith Street
 

Cincinnati, OH 98765
 

Company Contact: _____(signature)_____
 

Typed Name of Signer: _______________
 

Phone: _______________________
 

Fax: _____optional___________
 

Email address: _____ optional__________
 

Regulatory Action in Support of Which this Package is Submitted: 

EPA registration number: 98765-1, My Flea Product
 

Amendment to add ticks to the label.
 

Submission date: 

MM/DD/YY 

List of Submitted Documents: 

Volume 1	 Administrative materials (This list is for illustration purposes and does not 

attempt to list all of the necessary forms to support a specific regulatory 

action.) 

Amendment form 

Data Matrix 

Proposed label text 

Confidential Statement of Formula 

Volume 2	 Title of first data document (Guideline No.) 

Volume 3	 Title of second data document (Guideline No.) 

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ATTACHMENT 2 

SAMPLE TITLE PAGE 

TITLE 

Product ABCXYZ
 

Acute Oral Toxicity in Rats
 

TEST GUIDELINE 

OPPTS 870.1100 

AUTHOR 

John C. Davis 

STUDY COMPLETION DATE 

01/22/2008 

PERFORMING LABORATORY 

ABC Agricultural Laboratories 

940 West Bay Drive 

Wilmington, DE 33445 

LABORATORY PROJECT ID 

ABC 08-34 

PAGE COUNT 

1 of 35 

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ATTACHMENT 3 

SAMPLE CROSS REFERENCES TO A CONFIDENTIAL ATTACHMENT 

Reference on page 12 of the non-confidential text: 

Information claimed confidential has been removed to the confidential attachment. See 

Cross Reference 1. 

Reference on page 18 of the non-confidential text: 

Information claimed confidential has been removed to the confidential attachment. See 

Cross Reference 2. 

Complementary reference in the confidential attachment: 

Cross Reference 1, page 12
 

FIFRA reference: 10(d)(1)(A)
 

Reproduce the deleted text here. 

Complementary reference in the confidential attachment: 

Cross Reference 3, page 18
 

FIFRA reference: 10(d)(1)(B) 

Reproduce the deleted text here. 

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______________________________________________________________________________ 

______________________________________________________________________________ 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ATTACHMENT 4 

SAMPLE GOOD LABORATORY PRACTICE COMPLIANCE STATEMENTS 

Example 1: 

This study was conducted in accordance with 40 CFR 160. 

Study Director: _________signature_____________ Date: ________ 

Typed Name of Signer: _____________________________________ 

Typed Name of Laboratory: _________________________________ 

Sponsor: ______________signature_____________ Date: ________ 

Typed Name of Signer: _____________________________________ 

Typed Name of Company: ___________________________________ 

Submitter: _____________signature_____________ Date: ________ 

Typed Name or Signer: _____________________________________ 

Typed Name of Company: __________________________________ 

Example 2: 

The following is a detailed description of all differences between the practices used in the study 

and those required by 40 CFR 160: 

Study Director: _________signature_____________ Date: ________ 

Typed Name: _____________________________________________ 

Typed Name of Laboratory: _________________________________ 

Sponsor: ______________signature_____________ Date: ________ 

Typed Name of Signer: _____________________________________ 

Typed Name of Company: __________________________________ 

Submitter: _____________signature_____________ Date: ________ 

Typed Name of Signer: _____________________________________ 

Typed Name of Company: __________________________________ 

Example 3: 

The submitter of this study neither sponsored this study nor conducted it and does not know 

whether the study was conducted in accordance with 40 CFR 160. 

Submitter: _____________signature_____________ Date: ________ 

Typed Name of Signer: _____________________________________ 

Typed Name of Company: __________________________________ 

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ATTACHMENT 5 

GLOSSARY 

Applicant: Any person or entity who sends any application, petition, or other 

submission to OPP with the intention to persuade OPP to grant, modify, or 

leave unmodified a registration or other approval required as a condition 

of sale or distribution of a pesticide. (See 40 CFR 158.3). 

Author(s): Individual(s) primarily responsible for the intellectual content of a 

document. In the case of a document that meets the definition of a “study’

in 40 CFR 160.3, the study director should be identified as the author. 

Authorized Agent: A person residing in the United States who is designated by an applicant 

to act as his agent. If an applicant wishes to designate an agent, he must 

send the Agency a letter stating the name and U.S. mailing address of his 

agent. (See 40 CFR 152.50(b)(3).) If an authorized agent signs any of the 

statements described in this notice, then it should be made clear that he is 

doing so as the applicant’s (submitter’s) authorized agent.

Data: Information submitted by an applicant to satisfy an Agency data 

requirement such as those published in 40 CFR parts 158 and 161, or any 

other information requested by EPA or presented by the applicant in 

support of a scientific or regulatory decision by OPP. Includes, but is not 

limited to, data to support registration review, adverse effects information 

submitted under FIFRA 6(a)(2), information supporting applications for 

new or amended registration, experimental use permits, tolerance petitions 

and tolerance exemption petitions. This information is contained in 

documents that are collectively referred to as data. Studies (see definition 

below) are a subset of data. Studies are subject to the requirements of 40 

CFR 160, OPP’s Good Laboratory Practice Standards (GLPs).

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MRID: Master Record Identifier. A unique 8-digit number assigned to each 

document submitted to OPP. These documents are permanent records; 

you do not need to resubmit any document that has already been assigned 

a MRID unless specifically requested to do so by OPP. Use the MRID to 

cite a previously submitted document that supports a new regulatory 

action. Never re-use an MRID; EPA assigns a new MRID to an amended 

document in order to preserve the integrity of the records in our database. 

OECD Dossier: The Organization for Economic Co-operation and Development (OECD) 

has developed a format for pesticide data submissions that is accepted by 

numerous countries including the United States. See http://www.oecd.org. 

Performing 

Laboratory: Facility/facilities where a study or part of a study is conducted. 

Person: Includes an individual, partnership, corporation, association, scientific or 

academic establishment, government agency, or organizational unit 

thereof, and any other legal entity. (See 40 CFR 160.3.) 

Plant-incorporated 

protectant (PIP): A pesticidal substance that is intended to be produced and used in a living 

plant, or in the produce thereof, and the genetic material necessary for 

production of such a pesticidal substance. It also includes any inert 

ingredient contained in the plant, or produce thereof. (See 40 CFR 174.3) 

Sponsor: A person who initiates and supports, by the provision of financial or other 

resources, a study. (See 40 CFR 160.3.) 

Study: Any experiment at one or more test sites in which a test substance is 

studied in a test system under laboratory conditions or in the environment 

to determine or help predict its effects, metabolism, product performance, 

environmental and chemical fate, persistence and residue, or other 

characteristics in humans, other living organisms or media. The term 

“study” does not include basic exploratory studies carried out to determine 

whether a test substance or a test method has any potential utility. (See 40 

CFR 160.3.) 

Study Completion 

Date: Date the final report is signed by the study director. (See 40 CFR 160.3.) 

Study Director: Individual responsible for the overall conduct of a study. (See 40 CFR 

160.3 and 160.33.) 

Study Profile 

Template: A study profile records basic study information such as materials, 

methods, results, and the applicant’s conclusions in a standard format 

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known as the template that mirrors the template used by EPA science 

reviewers in preparing their Data Evaluation Records (DERs). 

Submission:	 Consists of all the documents sent to OPP at the same time in support of a 

single regulatory action or a group of related actions, such as a product 

amendment and a related tolerance petition by an Applicant (see definition 

above). The documents should be accompanied by a transmittal document 

and related administrative material (e.g., EPA Forms 8570-1, 8570-4, etc.) 

as appropriate. This transmittal document and administrative material 

should be grouped together in the first physical volume if the submission 

is on paper. Consult the e-submission XML guidance document at 

http://www.epa.gov/pesticides/regulating/registering/submissions/XMLsu 

bmissions/e-submission_xml_guidance_document_v1.pdf for specific 

information on the format of these documents as files on a CD/DVD. 

Submitter: Any person making a submission to OPP. 

Test Guideline:	 Number that identifies a published testing procedure. The OCSPP 

harmonized test guidelines are available at: 

http://www.epa.gov/ocspp/pubs/frs/home/guidelin.htm 

Transmittal 

Document:	 Provides the who, what, when and why of the data submission by 

identifying the submitter, submission date, regulatory action being 

supported, and a list of the documents included in the submission. See 40 

CFR 158.32(b), 161.32(a). 

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