1

Instructions for the Product-Specific Data Call-In

TABLE OF CONTENTS

Table of Contents ........................................................................................... 1

Chapter 1: Product Reregistration Process and Summary of Instructions .................... 2

Chapter 2: Instructions For Completing the “Data Call-In Response Form” for the

Product-Specific Data Call-In for the 90-Day Response ......................... 4

Task 1. How to Complete Items 1 through 5 of the Data Call-In Response Form

................................................................................................. 4

Task 2. How to Complete Items 7a and 7b of the Data Call-In Response Form

................................................................................................ 5

Task 3. How to Complete Items 8 through 11 on the Data Call-In Response 

Form ......................................................................................... 6

Chapter 3: Instructions for Completing the “Requirements Status and Registrant’s

Response Form” for Product-Specific Data for the 90 Day Response ........ 6

Task 1: Check Items 1 through 3 on the “Requirements and Registrant’s 

Response” Form ................................................................... 6

Task 2. Read the Description of items 4 through 8.................................... 8

Task 3. How to Complete Items 9 through 13 ........................................ 8

Option 1: Develop Data .................................................................. 10

Option 2: Agreement to Share in the Cost to Develop Data ............... 11

Option 3: Offering to Share in the Cost of Developing Data.............. 12

Option 4: Submitting an Existing Study ..................................... 13

Option 5: Upgrading a Study .................................................. 14

Option 6: Citing an Existing Study ........................................... 15

Option 7: Waiver Request ...................................................... 16

Option 8: “Not Applicable” ................................................... 16

Chapter 4. Sharing Testing Costs with Others Using Batching or Bridging ................. 17

Find Your Product’s Batch/ Names of Other Registrants in Your Batch ......... 18 

Requesting Rebatching or How to Rely on Data From Another Batch ........... 19 

Batching and Your 90-Day Response .................................................. 19

Batching Tables (example) ............................................................. 21

Chapter 5: How to Complete the Confidential Statement of Formula Form for the 8

Month Response ......................................................................... 21

Chapter 6. List of Available Documents ............................................................. 22
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Chapter 1: Product Reregistration Process and Summary of 

Instructions

Product Reregistration Process: Once a reregistration Eligibility Decision (RED) for a generic 

active ingredient is issued, reregistration of products containing the active ingredient begins. 

The table below helps explain the product reregistration process.

STEP ACTION

1 EPA issues RED and product-specific Data Call-In (DCI). 

2 Registrant responds to DCI by submitting the 90-Day Response.

3 EPA reviews 90-Day Response and answers requests from registrant.

4 Registrant submits application for reregistration, and any needed studies (the Eight 

Month Response).

5 EPA reviews the Eight Month Response.

6 EPA notifies registrant of results of review. 

Are product-specific data and the labels acceptable?

..........Yes – the product is reregistered *

.......... No – EPA may:

............. – require the registrant to submit additional or amended information, or 

..............– proceed with suspension action.

* A product is reregistered only after each active ingredient within the product has become 

eligible for reregistration.

Responding: The 90-Day Response: Once the RED is issued, product reregistration begins 

with EPA issuing a product-specific Data Call-In notice (DCI). To satisfy the requirements of 

this Data Call-in, registrants must respond within 90 days of receipt of this notice. This response 

is called the 90 Day Response. The following table lists the steps for responding to the DCI.

STEP ACTION

1 Locate the DCI forms sent with this DCI issuance. 

.......... Data Call-In Response Form

.......... Requirement Status and Registrant’s Response Form

2 Read the accompanying instructions.

3 Decide how you will respond.

4 Complete the forms.

5 Requests for time extensions for actual product specific data submissions (normally 

due at the 8 month response) and/or data waivers must be accompanied by a full 

justification and submitted as part of this 90-Day Response.

6 Submit forms and time extension requests/data waivers to your Chemical Review 

Manager (see contact name in DCI Notice Attachment #1).

Note: If your product is a 100% repack of another product registered with EPA, complete and 

submit only the Data Call-In Response Form as your 90-Day Response to the Agency.
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How to Comment on the RED: When the RED is issued, EPA solicits comments on the 

information and conclusions in the RED. Below is a table that explains the process for 

commenting on the RED.

STAGE DESCRIPTION

1 EPA issues the RED.

2 EPA announces RED availability in the Federal Register (FR).

3 Interested parties have 60 days to submit comments on the RED document once the 

FR Notice is published. Comments can be submitted to the Public Docket.

4 EPA Considers the responses and may amend the RED.

5 EPA announces in the FR that the RED is final and describes how comments were 

addressed.

Responding: The 8 Month Response: The following table lists the steps needed for submitting 

the 8 Month Response.

STEP ACTION

1 Locate the Confidential Statement of Formula (CSF) Form 8570-4, available at 

http://www.epa.gov/opprd001/forms/

2 Complete this form according to the accompanying instructions in Chapter 5 within 

this document.

3 Your 8 Month Response must contain:

 Two copies of the Confidential Statement of Formula form for each basic 

and alternate formulation.

 Application for Reregistration, EPA Form 8570-1, available at 

http://www.epa.gov/opprd001/forms/

 Five copies of the draft labeling revised according to requirements listed in 

the Fact Sheet.

 Certification with Respect to Citations of Data, EPA Form 8570-34, 

available at http://www.epa.gov/opprd001/forms/

 Certification of Attempt to Enter into an Agreement with other Registrants 

for Development of Data, EPA Form 8570-32, available at 

http://www.epa.gov/opprd001/forms/

 Product-specific Data if required by this Data Call-In Notice.

4 Submit this response within 8 months of receiving this notice.

Note: If your product is a 100% repack of another product registered with EPA, you must submit 

a Formulator’s Exemption Statement, EPA Form 8570-27, available at 

http://www.epa.gov/opprd001/forms/ and the first three items bulleted above under step 3 when 

you submit your 8 month response to the Agency.
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Chapter 2: Instructions For Completing the “Data Call-In Response 

Form” for the Product-Specific Data Call-In for the 90-Day 

Response

Task 1. How to Complete Items 1 through 5 of the Data Call-In Response Form

Description: Items 1-5 cover basic information about your products covered by this Data CallIn.

Diagram: This is a diagram of the Product Specific Data Call-In Response for your reference.

United States Environmental Protection

Agency Washington, D.C. 20460

DATA CALL-IN RESPONSE

OMB Approval XXXX-XXXX

Instructions: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.

Use additional sheet(s) if necessary.

1. Company Name and Address

Sample Company

Street Address

 City, State, zip code

2. Case # and Name

XXXX Sample Name

3. Date and Type of DCI and Number

02-Mar-2007

Product Specific

ID# PDCI-XXXXXX-XXXXX

4. EPA Product 

Registration

5. I wish to 

cancel the 

product 

registration 

voluntarily

6. Generic Data 7. Product Specific Data

6a. I am claiming a 

Generic Data 

Exemption because 

I obtain the active 

ingredient from the 

source EPA 

registration number 

listed below

6b. I agree to 

satisfy Generic 

Data 

requirements as 

indicated on the 

attached form 

entitled 

“Requirements 

Status and 

Registrant’s 

Response.”

7a. My product is 

an MUP and I 

agree to satisfy the 

MUP requirements 

on the attached 

form entitled 

“Requirements 

Status and 

Registrant’s 

Response.”

7b. My product is an EUP and I 

agree to satisfy the EUP 

requirements on the attached 

form entitled “Requirements 

Status and Registrant’s 

Response.”

XXXXXX-XXXX N.A. N.A.

8. Certification. I certify that the statements made on this form and all attachments are true, accurate, 

and complete. I acknowledge that any knowingly false or misleading statement may be punishable by 

fine, imprisonment or both under applicable law.

Signature and Title of Company’s Authorized Representative ____________________________

9. Date

10. Name of Company 11. Phone Number

Check Information in Items 1-5: Follow these steps for completing items 1-5.

STEP ACTION

A Check the accuracy of the preprinted information in item 1 (Company name, 

number, and address) and item 2 (Case number, case name, EPA chemical number 

and chemical name).

B Is the information in items 1 and 2 correct?

 If yes, move to step C.
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 If no, pencil in corrections on the form and move to step C.

Note: If your address is not correct, you must also formally change your address by 

sending a request separate from this action by U.S. mail to the following address:

Document Processing Desk (COADR)

Office of Pesticide Programs (7504C)

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, N.W.

Washington, DC 20460

C Look at item 3. Note that this form is entitled “Product Specific”.

Note: Product-specific data are from studies conducted on a pesticide product itself (i.e., on 

the pesticide product after it is formulated).

D Check item 4. This item identifies the EPA product registrations affected by the 

Data Call-In.

Note: Registrants are responsible for informing the Agency about any product that they 

believe may be covered by this Data call-In but that is not listed by the Agency in Item 4. 

They must notify the Agency of such omissions within 90 days of receipt of this form.

E Use the following instructions for a 100% repack:

 If your product is a 100% REPACK of another valid registered product, then 

write “REPACK OF PRODUCT (enter EPA registration number here)” 

prominently in block 7 on the form. Skip to Task 3 (Blocks 8, 9, 10, and 

11).

F Do you intend to voluntarily cancel any of your products?

 If yes, mark an “X” or “YES” in item box 5 across from the product you 

intend to cancel.

Note: This will initiate voluntary cancellation of this product. EPA will send 

you a letter notifying you of the cancellation.

 If no, move to Task 2, which explains item 7a and 7b.

Skip Items 6a and 6b: Items 6a and 6b do not apply to the product-specific data requirements in 

this notice. They deal with possible exemption from the generic data requirements. EPA uses 

the same form for both generic and product-specific data, however, items 6a and 6b apply ONLY 

to generic data.

Task 2. How to Complete Items 7a and 7b of the Data Call-In Response Form.

Description: Items 7a and 7b only apply to product-specific data. Use the following table to 

determine your responses to items 7a and 7b.

If you have a ... and .... then...

Manufacturing-use 

product (MUP)

You wish to maintain the 

registration

Mark “yes” in box 7a

End-use product (EUP) You wish to maintain the 

registration

Mark “yes” in box 7b
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Note: Even if you wish to request a data waiver, answer “yes” to the appropriate item (7a or 7b). 

Also on the Requirements Status and Registrant’s Response form discussed in Chapter 3 under 

item 9, respond with option 7 (Waiver Request) for each study for which a waiver is requested 

(see Task 3, Option 7 starting on page ).

Task 3. How to Complete Items 8 through 11 on the Data Call-In Response Form.

Authorized Signature and Contact Person: Use the following table to complete items 8-11.

STEP ACTION

A For item 8, an authorized representative of each company must sign the certification 

statement. Include the representative’s title. Additional pages used in the response 

must be initialed and dated in the lower left corner by this representative.

B For item 9, enter the date of signature.

C For item 10, enter the name of the person EPA should contact with questions 

regarding the response. 

D For item 11, enter the phone number of the company contact.

Note: Please provide additional information that does not fit on this form in a signed letter that 

accompanies the response. For example, you may wish to report that a product has been 

transferred to another company or that it has been voluntarily canceled. For these cases, please 

supply all relevant details.

Chapter 3: Instructions For Completing the “Requirements Status 

and Registrant’s Response” Form for Product-Specific Data for the 

90-Day Response

Task 1. Check Items 1 through 3 on the “Requirements Status and Registrant’s 

Response” Form.

Description: Items 1-3 describe basic information about your products covered by the Data CallIn, the requirements of which are listed on the “Requirements Status and Registrant’s Response” 

form. Below is a sample form.
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United States Environmental Protection

Agency Washington, D.C. 20460

REQUIREMENTS STATUS AND REGISTRANT’S RESPONSE

OMB Approval XXXX-XXXX

Instructions: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.

Use additional sheet(s) if necessary.

1. Company Name and Address

Sample Company

Street Address

 City, State, zip code

2. Case # and Name

XXXX Sample Name

3. Date and Type of DCI and Number

02-Mar-2007

Product Specific

ID# PDCI-XXXXXX-XXXXX

4. Guideline 

Requirement 

Number

5. Study Title P

r

o

t

Progress

Reports

6. Use Pattern 7. Test Substance 8. Time 

Frame 

(Months)

9. Registrant 

Response

1 2 3

830.1550

830.1600

830.1620

830.1650

Product identity

Description materials

Description of production

process

Description of formulation 

process

A,B,C,D,E,F,G

A,B,C,D,E,F,G

A,B,C,D,E,F,G

A,B,C,D,E,F,G

MP or EP

MP or EP

MP or EP

MP or EP

8 mos.

8 mos.

8 mos.

8 mos.

10. Certification. I certify that the statements made on this form and all attachments are true, accurate, 

and complete. I acknowledge that any knowingly false or misleading statement may be punishable by 

fine, imprisonment or both under applicable law.

Signature and Title of Company’s Authorized Representative ____________________________

11. Date

12. Name of Company 13. Phone Number

Check Information in Items 1-3: Follow these steps for checking items 1 through 3.

STEP ACTION

A Check the accuracy of the preprinted information in item 1 (Company name and 

address) and item 2 (Case number, case name, EPA registration number for that 

chemical).

B Is the information in items 1 and 2 correct?

 If yes, move to step C.

 If no, pencil in corrections on the form and move to step C.

Note: If your address is not correct, you must also formally change your address 

by sending a request separate from this action by U.S. mail to the following 

address:

Document Processing Desk (COADR)

Office of Pesticide Programs (7504C)

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, N.W.

Washington, DC 20460

C Look at item 3. This block is entitled “Product Specific”and has a unique identifier 

assigned by EPA (ID#).

 Product-specific data are from studies conducted using a pesticide product 

AFTER it is formulated with other ingredients (e.g., inert ingredients such 

as perfumes, solvents, or other pesticide active ingredients) into a 

manufacturing-use or end-use pesticide product.

 The unique ID# assigned by EPA must be used in any document 

transmitting any data submitted in response to this Product Specific DCI.
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Task 2. Read the Description of Items 4 through 8.

Description: Items 4 through 8 cover the information the Agency is requiring to be conducted 

on your specific product(s).

 Item 4 – Guideline Requirement Number – Identifies guideline requirement numbers for 

each study necessary to support the product’s continued registration.

 Item 5 – Study Title – Identifies the study title associated with the guideline requirement 

number.

 Item 6 – Use Pattern – Includes all possible use patterns of the pesticide.

 Item 7 – Test Substance – Identifies the form of the pesticide that must be tested.

 Item 8 – Timeframe – Identifies the amount of time given to conduct and submit the 

required study to the Agency starting from receipt of this Data Call-In Notice.

Task 3. How to Complete Items 9 through 13.

Item 9, Registrant Response: In order to show how you intend to comply with the data 

requirements listed in the “Requirements Status and Registrant’s Response” form, you must 

choose one response code (option) for each data requirement. You may select from the 

following options when indicating how you wish to respond to each data requirement in item 9.

Option 

Number

Description Definition Details 

on Page

1 Developing 

Data

You will generate and submit the data within the specified 

time frame.

2 Cost Sharing You will enter into an agreement with one or more registrants 

to develop data jointly, and share the cost.

3 Offer to Cost 

Share

You have made unsuccessful offers to other data submitters 

to cost share.

4 Submitting an 

Existing Study

You are submitting an existing study that has not been 

submitted previously to the Agency by anyone.

5 Upgrading an 

Existing Study

You are submitting or citing data to upgrade a study 

classified by EPA as partially acceptable and upgradeable.

6 Citing an 

Existing Study

You are citing an existing study that EPA has classified as 

acceptable or an existing study that has been submitted but 

not reviewed by the Agency.

7 Waiver 

Request

You are requesting the Agency to waive a required study 

because you believe it is inappropriate for your product. You 

must attach a complete justification for this request, 

including technical reasons, data and references to relevant 

EPA regulations, guidelines, or policies.

8 Not Applicable Your product meets the criteria for “not applicable” as 

expressed in the footnote for that specific Guideline 

requirement.
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Example #1

If you want to ... then select response 

code ....

and place response code in item 9

column next to that specific study ...

Develop the data 1 e.g., Guideline 830.1550

Submit an existing study 4 e.g., Guideline 830.1600

The diagram below of the “Requirements Status and Registrant’s Response” form illustrates 

Example #1.

United States Environmental Protection

Agency Washington, D.C. 20460

REQUIREMENTS STATUS AND REGISTRANT’S RESPONSE

OMB Approval XXXX-XXXX

Instructions: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.

Use additional sheet(s) if necessary.

1. Company Name and Address

Sample Company

Street Address

 City, State, zip code

2. Case # and Name

XXXX Sample Name

3. Date and Type of DCI and Number

02-Mar-2007

Product Specific

ID# PDCI-XXXXXX-XXXXX

4. Guideline 

Requirement 

Number

5. Study Title P

r

o

t

Progress

Reports

6. Use Pattern 7. Test Substance 8. Time 

Frame 

(Months)

9. Registrant 

Response

1 2 3

830.1550

830.1600

830.1620

830.1650

Product identity

Description materials

Description of production 

process

Description of formulation 

process

A,B,C,D,E,F,G

A,B,C,D,E,F,G

A,B,C,D,E,F,G

A,B,C,D,E,F,G

MP or EP

MP or EP

MP or EP

MP or EP

8 mos.

8 mos.

8 mos.

8 mos.

1

4

10. Certification. I certify that the statements made on this form and all attachments are true, accurate, 

and complete. I acknowledge that any knowingly false or misleading statement may be punishable by 

fine, imprisonment or both under applicable law.

Signature and Title of Company’s Authorized Representative ____________________________

11. Date4

12. Name of Company 13. Phone Number

Items 10 through 13: Use this table to complete items 10-13.

STEP ACTION

A For item 10, an authorized representative of each company must sign the 

certification statement. Include the representative’s title. Additional pages used in 

the response must be initialed and dated in the lower left corner by this 

representative.

B For item 11, enter the date of signature.

C For item 12, enter the name of the person EPA should contact with questions 

regarding your response. 

D For item 13, enter the phone number of your company contact.

For 100% Repacks: If your product is a 100% repack of another product registered with EPA, 

then you will not be conducting product-specific data and you do not need to submit this form.
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Option 1: Develop Data

Introduction: Select Option 1 if you are going to develop data to satisfy this data requirement.

By selecting this option, you certify that you will comply with all the requirements for 

submitting this study as outlined in the Data Call-In Notice.

Rules: 

 If you choose to develop the required data, it must conform with deadlines and 

requirements referenced in this notice. 

 All data generated and submitted must comply with the Good Laboratory Practice rule 

(40 CFR Part 160), be conducted according to the Pesticide Assessment Guidelines 

(PAG), and be in conformance with the requirements of PR Notice 86-5. 

 The Agency does not grant time extensions for the 90-Day Response.

How to Use Option 1: Complete the following steps if you choose Option 1.

STEP ACTION

1 Enter “1” next to the guideline requirement, under column 9, on the “Requirements 

Status and Registrant’s Response” form for which you will develop data.

Data submission deadline: The time frames stated in column 8 in the “Requirements Status and 

Registrant's Response” form are those the Agency is allowing for submission of completed studies. 

These deadlines are calculated from the date of receipt of the DCI Notice by the registrant. If the data are 

not submitted by the deadline, the registrant is subject to receipt of a Notice of Intent to Suspend the 

affected registration(s).

Requesting Time Extension for Studies: If you intend to seek additional time to meet the data 

requirement(s), use the following procedure to request a time extension.

STEP ACTION

1 Prepare a request which includes:

 A detailed description of the expected technical or laboratory difficulty; and

 A proposed date for meeting the requirement.

2 Provide documentation from the laboratory performing the testing.

3 Submit request to your Chemical Review Manager (see contact name in DCI Notice

Attachment #1).

Conditions for Approval: Normally, extensions can be requested only in cases of extraordinary 

testing problems beyond the expectation or control of the registrant.

Extensions will not be considered if the request for extension is not made in a timely fashion; in 

no event shall an extension request be considered if it is submitted at or after the subject 

deadline.

EPA Response: EPA will review your request and respond in writing. While the Agency is 

considering your request, the original deadline remains. The possible outcomes are as follows:
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If ... then ....

the Agency approves your request, a new due date will be assigned.

the Agency denies your request, the due date specified in your original due date 

from the DCI will not normally be changed and 

the Agency may proceed with enforcement action 

against the affected product registration.

Option 2: Agreement to Share in the Cost to Develop Data

Introduction: Select Option 2 for each specific guideline for which you have an agreement to 

share in the cost of developing data.

Note: Do not select this option if you have offered to cost share and have been rejected by 

the other registrant(s) (see Option 3).

Rules: This option is only available:

 For acute toxicity data and certain efficacy data, and

 When EPA has indicated that at least two products are similar and can depend on the 

same data (see page ).

How to Use Option 2: Complete the following steps if you choose Option 2.

STEP ACTION

1 Enter “2” next to the guideline requirement, under column 9, on the “Requirements 

Status and Registrant’s Response” form for which you have a cost share agreement, 

once you have determined that your product is eligible (based on the criteria set 

forth in the Rules above).

2 Submit to the Agency a completed EPA Form 8570-32, Certification of Attempt to 

Enter into an Agreement with other Registrants for Development of Data, which is

available at http://www.epa.gov/opprd001/forms/ (see page ).

Provide the Registration Number of the product for which the data will be 

submitted. If you are not producing the data yourself, you must also provide the 

name of the registrant who will be producing the data under your agreement to cost 

share.

3 Submit with the 90-Day Response evidence that an agreement exists.

Evidence may include, for example:

 A letter offering to join in an agreement along with an acceptance letter from 

the other registrant; or

 A written statement by the parties that an agreement exists.

4 Notes: 

 The other registrant must fulfill its commitment to develop and submit the 

data.

 If the other registrant fails to develop the data or for some other reason is 

subject to suspension, your registration will also be subject to the initiation 

of suspension proceedings, unless you commit to submit, and do submit the 
12

required data in the specified time frame. In such cases, the Agency 

generally will not grant a time extension.

Note: The agreement to produce the data need not specify all the terms of the final arrangement 

between the parties or the mechanism to resolve the terms. Section 3(C)(2)(B) of FIFRA 

provides that if parties cannot resolve the terms of the agreement, they may resolve them through 

binding arbitration.

Option 3: Offer to Share in the Cost of Developing Data

Introduction: Select Option 3 for each specific guideline for which you have made an offer to 

pay, or enter into or amend an existing agreement, to share in the cost of developing data, and 

you have been rejected by the other registrant(s).

As a general policy, the Agency will not suspend the registration of a product in situations where 

the registrant has in good faith sought and continues to seek to enter into a joint data 

development program and where the other registrant(s) developing data has refused to accept the 

offer.

By choosing this option, you are requesting the Agency to exercise its discretion not to suspend 

your registration(s), even though you did not comply with the data submission requirement.

Rules: This option is only available:

 for acute toxicity data and certain efficacy data, and 

 if EPA has indicated that at least two products are similar and can depend on the same 

data (see page ).

How to Use Option 3: Complete the following steps if you choose Option 3.

STEP ACTION

1 Enter “3" next to the guideline requirement for which you have offered to share in 

the cost of developing data, once you have determined that you qualify for this 

option. To qualify for Option 3, you must submit documentation to the Agency 

proving that you have made an offer to another registrant (who has an obligation to 

submit the data) to share in the burden of developing data.

2 Submit to the Agency a completed Form 8570-32, Certification of Attempt to Enter 

into an Agreement with other Registrants for Development of Data, which is

available at http://www.epa.gov/opprd001/forms/ (see page ).

Note: Your offer to cost share will be subject to binding arbitration as provided by 

FIFRA section 3(c)(2)(B)(iii) and must not include any conditions that qualify this 

offer.

3 Provide proof that the registrant to whom you made the offer to cost share has not accepted

your offer.

Example: A copy of your offer and proof of the other registrant’s receipt of that offer (such 

as a certified mail receipt).
13

4 The other registrant must also inform the Agency that it intends to develop and 

submit the data by indicating this on the “Data Call-In Response” form, and 

“Requirements Status and Registrant’s Response” form.

Notes: 

 The other registrant must fulfill its commitment to develop and submit the 

data.

 If the other registrant fails to develop the data or for some other reason is 

subject to suspension, your registration will also be subject to the initiation 

of suspension proceedings, unless you commit to submit, and do submit the 

required data in the specified time frame. In such cases, the Agency 

generally will not grant a time extension.

 In order for you to avoid suspension under Option 3, you may not withdraw 

your offer to cost share.

Option 4: Submitting an Existing Study

Introduction: Select Option 4 for each specific guideline for which you would like to submit an 

existing study that satisfies the requirements of this Data Call-In Notice. Do not use this option 

if you are submitting data to upgrade a study.

What is an existing study: An existing study is one that:

 Predates the DCI Notice; and

 Has not been previously submitted to the Agency (or cited by anyone).

Criteria for Existing Study: To submit an existing study, the following three criteria must be 

met.

Criteria DESCRIPTION

1 Raw data and specimens from the study are available for audit and review.

 you must certify that these are available.

 you must also identify where they are available.

2 The study contains all quality assurance and quality control information required by 

Good Laboratory Practice Standards (see 40 CFR Part 160). 

3 The study fulfills the purpose of the acceptance criteria for the study, and the study 

has been conducted in accordance with the Pesticide Assessment Guidelines (PAG) 

(see page on how to obtain a copy of the acceptance criteria and the PAG). Or, 

a study not conducted according to the PAG may be submitted to the Agency if the 

registrant certifies that the study meets the purpose of the PAG. Refer to 40 CFR 

158.70 for the Agency’s policy regarding acceptable protocols.

Suspension for Inadequate Study: If the existing study does not meet the Agency’s standards, 

then the Agency may suspend registration of the pesticide products supported by these data.
14

Reporting Unreasonable Adverse Effects: You must notify the Agency if you know of a study 

containing factual information regarding unreasonable adverse effects pertaining to any 

requirement in this Notice, even if the study does not meet the criteria above.

How to Use Option 4: Complete the following steps if you choose Option 4.

STEP ACTION

1 Enter “4" next to the guideline requirement for which you have decided to submit an 

existing study.

Option 5: Upgrading a Study

Introduction: Select Option 5 for each specific guideline for which you have a previously 

rejected, but upgradable, study that can be amended to satisfy a data requirement in the DCI 

Notice.

What is Upgradable: The term “upgradable” is a term used by the Agency in its reviews to 

describe the quality of a study. If the Agency determines that a study is upgradable, then the 

study may be made acceptable if certain critical information is supplied.

Example: Purity of Test Material: Providing the purity of the test material is an example of 

information that could be used to upgrade a study.

Counter-example: No NOAEL Established: For example, if a No Observed Adverse Effect 

Level (NOAEL) is not established during a toxicity study, then a study can not be upgraded. The 

Agency’s review would state this. The study would need to be repeated to obtain the necessary 

information.

How to Use Option 5: Complete the following steps if you choose Option 5.

STEP ACTION

1 Look at the Agency’s review of the study. Has the study been reviewed by EPA and 

found to be “upgradeable” ? 

 If no, select another option. Do not submit additional data to upgrade a 

study if the Agency has determined that it can not be upgraded. 

 If yes, go to step 2.

2 Mark “5" on the “Requirements Status and Registrant’s Response” form.

3 Submit the additional data to correct all deficiencies identified by EPA as you would 

any other submission of data (see page for further explanation on how to 

request a copy of PR notice 86-5 which explains this procedure). Make sure to 

reference the MRID number of the study you are upgrading.

If the Upgrade is Rejected: If the agency decides the requirement is not satisfied by the 

additional data that you submit, you may still be required to submit new data usually without a 

time extension. Also, once you exceed the due-date for the submission of your study, your 

product registration is subject to enforcement action (suspension).
15

Already Submitted Information to Upgrade: Select this option if you have already submitted 

information to upgrade the study and the Agency has not yet reviewed it. With your 8-month 

response, submit a separate page with MRID numbers of both the original submission and that of 

the new data upgrading the original submission.

Option 6: Citing an Existing Study

Introduction: Select Option 6 for each specific guideline for which you have an existing study 

that the Agency has classified as acceptable, or that has been submitted but not reviewed by the 

Agency.

Citing Another Registrant’s Data: Rules:

 This option is available only for acute toxicity or certain efficacy data.

 The cited study must have been conducted on your product, an identical product, or a 

product which EPA has “grouped/batched” with your product, or which EPA agrees 

provides an appropriate bridge.

 If you decide to cite another registrant’s data, you must also submit a completed 

“Certification with Respect to Citations of Data,” EPA form 8570-34, available at

http://www.epa.gov/opprd001/forms/ (see page ).

How to Use Option 6: Whether you are citing your own data or another registrant’s study, you 

must complete the following steps if you choose Option 6.

STEP ACTION

1 Enter “6" next to the guideline requirement for which the Agency has an existing 

study previously classified as acceptable* or an existing study that has been 

submitted but not reviewed by the Agency on the Requirements Status and 

Registrant’s Response Form under column 9, the Registrant Response column.

2 By the specified due date, you must provide the MRID or Accession number(s) for 

the cited data with your 8-month response.

Criteria for Citing an Existing Study: To cite an existing study, the following criteria must be 

met:

Criteria DESCRIPTION

1 The study contains all quality assurance and quality control information required by 

Good Laboratory Practice Standards (see 40 CFR Part 160). 

2 The study fulfills the purpose of the acceptance criteria for the study, and the study 

has been conducted in accordance with the Pesticide Assessment Guidelines (PAG) 

(see page on how to obtain a copy of the acceptance criteria and the PAG).

Suspension for Inadequate Study: If the cited existing study does not meet the Agency’s 

standards, then the Agency may suspend registration of the pesticide products supported by these 

data.
16

Option 7: Waiver Request

Introduction: Select Option 7 for each specific guideline for which you believe the data 

requirement is inappropriate for your product.

Example: A registrant requested and received a waiver for the acute inhalation toxicity study 

(Guideline 870.1300) because they believed their product did not pose an inhalation hazard 

because it was a paste that had no volatile components.

How to Request a Waiver: Follow these steps to request a waiver.

STEP ACTION

1 Enter “7" next to the guideline requirement you would like to have waived on the 

Requirements Status and Registrant’s Response Form under column 9, the 

Registrant Response column.

2 Attach a complete justification for this request, including technical reasons, data, 

and references to relevant EPA regulations, guidelines or policies.

Note #1: Any supplemental data must be submitted in the format required by PR 

Notice 86-5.

Note #2: This is your only opportunity to state the reasons or provide information 

in support of your request. If the Agency approves your waiver request, you will 

not be required to supply the data pursuant to Section 3(c)(2)(B) of FIFRA.

What if the waiver Request is Denied: If the Agency denies your request you must:

 Within 30 days of your receipt of the Agency’s written decision, submit a revised 

“Requirement Status and Registrant’s Response” form with a new response option 

chosen (for the requirement study that was denied the waiver status).

 Meet the deadline for submission of data as specified by the original DCI Notice.

Option 8: “Not Applicable”

Introduction: Select Option 8 for each specific guideline only if your product meets the criteria 

for not applicable, as expressed in the footnote for that specific guideline. To determine if a 

relevant footnote exists, refer to the bottom of the “Requirements Status and Registrant’s 

Response” form. These footnotes are reproduced from the 40 CFR, sections 158.190, (Physical 

and Chemical Characteristics) and 158.340, (Toxicology).

Example: If your product is a solid, the boiling point study would not be applicable, as 

expressed in footnote (7).

Contrast with Data Waivers: In data waiver situations, the justification for not performing the 

test involves issues not covered by a footnote.

Instructions: To claim a requirement as not applicable:
17

STEP ACTION

1 Enter “8" next to the requirement you consider to be inapplicable under column 9 on 

the Requirements Status and Registrant’s Response Form. 

2 Prepare and attach a complete justification for this request, including technical 

reasons, based on the footnote.

EPA will then review your request. The possible outcomes are as follows:

If ... then ....

the Agency approves 

your request,

you will not be required to supply the data.

the Agency denies 

your request,

submit a revised “Requirements Status” form with a new response 

option within 30 days of your receipt of the Agency’s written 

decision. You must choose a method of meeting the data requirements 

of this Notice by the due date stated in this Notice. The due date 

specified in your original DCI generally will not be changed.

Chapter 4: Sharing Testing Costs with Others Using Batching or 

Bridging

Introduction: To reduce the resources needed to fulfill the acute toxicity data requirements for 

reregistration, the Agency allows acute toxicity testing of one or more selected products to 

represent a group of products. This may be done using “batching” or “bridging”. 

Note: The Agency reserves the right to require, at any time, acute toxicity data for an individual 

product.

What is Batching: Batching is the Agency’s process of grouping together products. The acute 

toxicity of a “batch” of similar products may be characterized by a set of tests on one product 

instead of for each product within the batch. The registrant may select any product in the batch 

as the test material. For example, products with identical formulations would be placed in the 

same batch for acute toxicity testing.

What is Bridging: Sometimes the Agency will batch together similar but not identical products. 

To characterize the range of toxicity within this type of batch, the Agency may chose certain 

products within the batch for testing. This is called bridging. The Agency may select the 

product(s) within a batch that will best characterize the range of potential toxicity of products 

within the batch. When the Agency selects the products to be tested it will state so in the 

batching tables. Registrants may also propose bridging strategies for approval by the Agency.

Criteria Used for Batching: The Agency uses the following criteria to group products into 

batches: 

1) Type of formulation (e.g. emulsifiable concentrate, wettable powder, etc.).

2) Active and inert ingredients:

 identity
18

 percent composition

 toxicological activity

Policy: Not Substantially Similar: Applications for new “me-too” products must be 

“substantially similar” to a currently registered product. Products in the same batch are 

considered “toxicologically similar” but may not be “substantially similar” since some products 

within a batch may not be considered chemically similar or have identical use patterns. 

Others May Cite Studies: Choosing not to participate with other registrants in a batch does not 

preclude those other registrants from citing your studies and offering to “cost-share” for those 

studies.

How to Find Your Product’s Batch and the Names of Other 

Registrants in Your Batch

Introduction: The Agency provides both a table listing products in your batch and a list of 

registrants sent the product-specific Data Call-In so that you may contact them to plan a testing 

strategy.

Who’s in Your Batch: Use the following table to identify your products’s batch and the other 

registrants with products in your batch:

STEP ACTION

A Refer to the enclosed batching tables. Look for your product’s “registration number” 

in the “EPA Reg. No.” column. Is your product listed? 

 If yes, note the batch in which your product has been placed. Now go on to 

Step B. 

 If no, contact your Chemical Review Manager (see contact name in DCI 

Notice Attachment #1).

B Note the company numbers of the other products in your batch. The first set of 

numbers in the Registration Number identifies the company; the second, the product. 

For example, take this Registration Number “524-23”: the Company Number is 524 

and under that company number the Product Number is 23.

C Now locate the enclosed “List of All Registrants Sent This Data Call-In Notice.”

D Look in the left column which lists these registrants’ company numbers. Find the 

company numbers of other registrants in your batch. Look across the table to find 

their names and addresses (e.g., company number 524 identifies the Monsanto 

Company).

E Contact other companies in your batch about sharing the cost of testing.

F If you decide to cooperate with others in a batch, then you may choose to participate 

with:

 all other registrants, or

 only some of the other registrants 
19

Requesting Rebatching or How to Rely on Data From 

Another Batch

Introduction: You may believe that the acute toxicity of your product can be adequately 

characterized by data from another batch of products. In this case you may request that your 

product be rebatched.

Circumstances Requiring Rebatching: The following circumstances commonly require 

rebatching of products:

 You have recently changed your formula;

 Your product’s Confidential Statement of Formula is out-of-date.

How to Request Rebatching: Use the following instructions to request “rebatching”:

Write a letter explaining why your product should be in another batch and send it to your Product 

Reregistration Manager (see cover letter for their name and address). Provide a detailed rational 

which supports your claim. Submit a new Confidential Statement of Formula with your letter.

Requesting Initial Batching: Occasionally, a product may be registered or reinstated during the 

time lag between batching and mailing the Product Specific Data Call-in Package. In this case 

request initial batching. Follow the same instructions as for “rebatching” described above.

Batching and Your 90-Day Response

Introduction: If you choose to participate in a batch to satisfy your acute toxicity testing 

requirements, indicate that in your 90-day response.

List of Response Options: You may select from the following options when completing your 

90-day Response. Please refer to the instructions for the “Requirements Status and Registrant’s 

Response” form in Chapter 3 for a detailed discussion of these options.

Option Number Description

1 Developing Data

2 Cost Sharing

3 Offer to Cost Share

4 Submitting an Existing Study

5 Upgrading an Existing Study

6 Citing an Existing Study

7 Waiver Request

8 Not Applicable

Choosing Response Options: Use the following table to determine the universe of acceptable 

response options for the “Requirements Status and Registrant’s Response” form.
20

If you are ... Then select option ....

Supplying data to support a 

batch of products.

1, 4, 5, or 6

Depending on another’s 

data.

2, 3, or 6

Not participating in a batch 

(supplying data for only 

your product).

1, 4, 5, or 6

Requesting a waiver. 7

For guidance on requesting a waiver, please see the footnotes 

following the “Requirements Status and Registrant’s Response” 

form. 

Note: Common justifications for requesting waivers include:

 test can not be performed (for example acute inhalation 

testing is not required if test material can not be 

formulated into respirable particles)

 test is not needed (for example, primary dermal 

irritation is not needed if the material is known to be 

highly acutely toxic by the dermal route).

Claiming the study is 

inapplicable.

8

For guidance on claiming the study inapplicable, please see the 

footnotes following the “Requirements Status and Registrant’s 

Response” form.

For example: 

 the requirement for boiling point would be inapplicable 

if the product was formulated as a solid.

Choices for Participation: Registrants of products within a batch may choose to cooperatively 

generate, submit or cite a single battery of six acute toxicological studies to represent all the 

products within that batch. Use the following table to decide whether to generate a new study or 

cite an existing study.

If a registrant ... Then the registrant ....

chooses to generate 

data for a batch

must use one of the products within the batch as the test material

chooses to rely upon 

previously submitted 

data

may do so provided that the:

 the data are complete (see Chapter Six, List of Available Documents, 

for information on how to obtain acceptance criteria),

 the formulation tested is considered by EPA to be similar for acute 

toxicity, and 

 the formulation has not been significantly altered since submission and 

acceptance of the acute toxicity data.
21

Note: When submitting studies for Agency review, clearly identify the test material by EPA 

Registration Number. If more than one Confidential Statement of Formula (CSF) exists for a 

product, identify the corresponding CSF.

Batching Tables (example)

Batch 1: Example

Registration Number Percent Active 

Ingredient: ethafluralin

Formulation:

62719-184 10% Granular

65242-135 10% Granular

ND90000200 10% Granular

ND91000200 10% Granular

Acute data on any product in batch 1 (listed above) may be used to support any other batch 1 

product.

Batch 2: Example

Registration Number Percent Active 

Ingredient: ethafluralin

Formulation:

34704-610 36.1% Liquid

51036-190 36.1% Liquid

And so on ...

Again, acute data on any product in batch 2 (listed above) may be used to support any other 

batch 2 product.

Chapter 5: How to Complete the Confidential 

Statement of Formula Form for the 8 Month Response

Introduction: Two signed copies of the CSF (EPA Form 8570-4, which is available at 

http://www.epa.gov/opprd001/forms/ ) are required for each basic and each alternate formulation 

of a product undergoing reregistration. This form is part of the “8 Month Response.”

Rules: The following rules apply to all CSFs submitted to the Agency:

 The CSF must comply with PR Notice 91-2 by declaring the active ingredient as a 

nominal concentration.

 All blocks in the form must by filled out completely. If any block is not applicable, mark 

it N/A.
22

 The CSF must be signed and dated, with the telephone number and name of the 

responsible party provided.

 All applicable information which is on the product specific data submission must also be 

reported on the CSF.

 When new CSFs are submitted and approved, all previously submitted CSFs become 

obsolete for that specific formulation.

Procedure for Completing the CSF Form: The following steps will assist you in completing 

the CSF form:

Note: Please refer to the back of the original form for further information.

STEP ACTION

1 In boxes 1-6, enter the appropriate information.

2 In box 7, enter all weights as pounds per gallon for liquids and pounds per cubic feet 

for solids.

3 In box 8, indicate the pH of the product.

4 In box 9, the flashpoint must be in degrees fahrenheit and flame extension in inches.

5 In boxes 10-12, list the components in the formulation, the supplier and the 

Registration number of the currently registered source products. Notes:

 The Chemical Abstracts Service (CAS) Numbers for all actives and inerts 

and all common names for the trade names must be reported.

 For active ingredients, the percent purity of the source product must be 

reported under column 10 and must be exactly the same as on the source 

product’s label.

6 In box 13, all weights must be in pounds, kilograms or grams. Notes:

 In no case will volumes be accepted.

 Do not mix English and metric system units (i.e. pounds and kilograms).

 All items under 13.b. must total 100.00 percent.

7 In box 14, all items under 14.a. and 14.b. for the active ingredients must represent 

pure active form. Notes:

 The upper and lower certified limits for all active and inert ingredients must 

follow the 40 CFR 158.175 instructions.

 An explanation must be provided if the proposed limits are different than 

standard certified limits and they must be supported by the analysis of 5 

batches that are submitted along with the certification statement.

8 In boxes 15-21, enter the appropriate information, including the date of the 

application to which this form applies.

Chapter 6. List of Available Documents

Introduction: The Agency provides reference materials concerning this RED document, 

including additional copies, and general information on the pesticide reregistration program.
23

If you want ... Then contact .... And request . . .

1. PR Notice 2011-3 

updates and replaces 

PR Notice 86-5: 

Standard Format for 

Data Submitted Under 

FIFRA and Certain 

provisions of FFDCA

http://www.epa.gov/pesticides/PR_Notices/pr2011-3.pdf

OR

National Technical Information Service (NTIS) 

5301 Shawnee Road 

Alexandria, VA 22312

Tel: 1-800-553-6847 or 703-605-6000

Email: info@ntis.gov

http://www.ntis.gov/

EPA Number

540/PR-99-007

2. PR Notice 91-2:

Accuracy of Stated 

Percentages for 

Ingredients Statement

http://www.epa.gov/pesticides/PR_Notices/pr91-2.htm

OR

See NTIS information above.

EPA Number

540/PR-99-008

3. The Agency’s 

Acceptance Criteria 

(within the FIFRA 

Accelerated Reregistration Phase Three 

Technical Guidance 

Package)

See NTIS information above. PB-90-161530

4. Application for 

Pesticide 

Registration

Find at http://www.epa.gov/opprd001/forms/

OR

Office of Pesticide Programs (OPP) (7504P)

U.S. Environmental Protection Agency

1200 Pennsylvania Ave., NW

Washington, DC 20460 

Tel: 703-308-8893 for conventional pesticide products

Tel: 703-308-6427 for antimicrobial pesticide products

Tel: 703-308-0152 for biological/biochemical pesticide products

Form 8570-1

5. The Confidential 

Statement of 

Formula (CSF) form

See OPP information above. Form 8570-4

6. Formulator’s 

Exemption 

Statement form

See OPP information above. Form 8570-27

7. A complete copy 

of this or any other 

RED document.

Find the specific docket for a particular RED at:

http://www.regulations.gov/

OR

EPA’s “National Service Center for Environmental Publications” 

(EPA/NSCEP)

U.S. EPA/ NSCEP

P.O. Box 42419

Cincinnati, OH 45242-0419 

Tel: 1-800-490-9198, Fax: 301-604-3408

Email: nscep@bps-lmit.com

http://www.epa.gov/nscep/ 

OR

EPA Publication 

Number
24

See NTIS information above.

8. Electronic copies 

of this or any other 

RED and fact sheet, 

and PR Notices.

Using World Wide Web, Find RED at:

http://www.epa.gov/pesticides/reregistration/status.htm

OR

http://iaspub.epa.gov/apex/pesticides/f?p=chemicalsearch:1

Find Notices at:

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

9. More information 

about EPA’s 

pesticide 

reregistration 

program, the RED, 

or reregistration of 

individual pesticide 

products.

See:

http://www.epa.gov/oppsrrd1/reregistration/reregistration_facts.htm

http://www.epa.gov/pesticides/reregistration/productreregistration.htm

http://www.epa.gov/oppsrrd1/reevaluation/index.htm

http://www.epa.gov/oppad001/contacts_ad.htm

http://www.epa.gov/oppbppd1/biopesticides/contacts_bppd.htm

Pesticide Re-evaluation Division (7508P)

Office of Pesticide Programs (OPP)

US EPA

1200 Pennsylvania Ave., 

N.W. Washington, DC 20460 

Tel: 703-308-8000 for conventional pesticides

Antimicrobials Division (7510P)

Office of Pesticide Programs (OPP)

US EPA

1200 Pennsylvania Ave., 

N.W. Washington, DC 20460 

Tel: 703-308-6411 for antimicrobials

Biopesticides and Pollution Prevention Division (7511P)

Office of Pesticide Programs (OPP)

US EPA

1200 Pennsylvania Ave., 

N.W. Washington, DC 20460 

Fax: 703-308-7026 for biologically-based pesticides

10. Information 

about the health 

effects of pesticides, 

or assistance in 

recognizing and 

managing pesticide 

poisoning 

symptoms.

National Pesticides Information Center (NPIC)

Oregon State University

310 Weniger Hall

Corvallis, OR 97331-6502

Tel: 1-800-858-7378

Email: npic@ace.orst.edu

http://npic.orst.edu/