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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
' WASHINGTON, D.CJ 20460
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Fax-On-Demand
Telephone: (202)401-0527
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OFFICE OF
PBEVENTION, PESTICIDES AND
TOXIC SUBSTANCES
6/12/1998
PESTICIDE REGISTRATION (PR) NOTICE 98-5
NOTICE TO MANUFACTURERS, PRODUCERS, FQRMULATORS,
AND REGISTRANTS OF PESTICIDE PRODUCTS
ATTENTION:
SUBJECT:
Persons Responsible for Federal Registration and Reregistration of
Pesticide Products
New forms for the Certification with Respect to Citation of Data
I. INTRODUCTION • ,
The Office of Pesticide Programs (OPP) of the Environmental Protection Agency (EPA)
announces new forms for citation of data to support the registration or reregistration of pesticide
products. EPA Forms 8570-34 ("Certification with Respect to Citation of Data") and 8570-35
("Data Matrix"). . .
' Form 8570-34 replaces Forms 8570-29 and 8570-31 and Form 8570-35 replaces Form
8570-20 and the "Blue Book Sample Matrix Format." As of the date of this notice the old forms may
no longer be used. The new forms will streamline data compensation for both registration and
reregistration of pesticide products by merging three forms into two and by reducing the paperwork
burden for both EPA and the pesticide industry. The same forms will be used for the registration,
reregistration and special review1 of pesticides. ' ' •
II. BACKGROUND INFORMATION
The Environmental Protection Agency (EPA, or the Agency) is responsible under section 3 of
the Federal Insecticide,' Fungicide, and Rodenticide Act (FIFRA) for registering pesticide products on
the basis of scientific data or other information adequate to show that, among other things, the products
will not .pose unreasonable adverse effects on the environment. After registration, under section
3(c)(2)(B) of FIFRA, EPA may require pesticide registrants to generate and submit data to the Agency
where such data is needed to assess whether certain pesticides should continue to be registered.
when responding to data call-ins issued under section 3 (c)(2)(B) of FIFRA
. Internet Address (URL) • http://www.epa.gov
Recycled/Recyclable •Printed with Vegetable OH Based Inks on Recycled Paper (Minimum 20% Postconsumer)
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An individual or entity wanting to obtain or maintain a registration for a pesticide product
must submit an application package consisting of information relating to the identity and
composition of the product, and supporting data or a citation to supporting data that have previously
been submitted to the Agency. In the latter case, the applicant generally must also certify that an
offer of compensation has been made to the original data submitter or that the submitter has granted
permission to cite data. Applicants make this certification by submitting a "Certification with
Respect to Citation of Data" form (Now Form 8570-34, which replaces Forms 8570-29 and -31).
The consequence of using another company's data to support a pesticide registration without
an offer of compensation is possible cancellation of the pesticide registration. FIFRA places an
obligation on the Agency to ensure that the original data submitter is offered compensation for the
use of data. The specifics as to the amount and terms of compensation are not within the Agency's
purview. Rather, the Federal Mediation and Conciliation Service will appoint an arbitrator to resolve
these specifics upon the request of either party.
In the mid-1990s, the pesticide industry formed a "Data Compensation Task Force"
consisting of pesticide manufacturers, formulators, and distributors. Collectively, the group
represents both original data submitters and those that use another's data to support registration. The
Task Force was formed to develop a mechanism for the pesticide industry to better protect its data
rights by, among other things, making it easier for industry to self-police the FIFRA data
compensation scheme.
The Task Force provided input to EPA for improving the existing data citation and
compensation forms used by the Agency to track compliance with the requirements of FIFRA. The
Agency agreed that improvements could be made and has therefore developed a new EPA Form
8570-34 ("Certification With Respect to Citation of Data") and EPA Form 8570-35 ("Data Matrix").
These forms will be used for registration, reregistration and special review purposes. Form 8570-34
and the "Public File Copy" of Form 8570-35 will be placed in a publicly available file once a
pesticide is registered. This file will provide data submitters with faster, easier access to these
documents than can be obtained through the Freedom of Information Act.
III. OVERVIEW OF CHANGES IN NEWFORMS
EPA Forms 8570-34 ("Certification with Respect to Citation of Data") and 8570-35 ("Data Matrix")
supplement and are integral to one another. These forms have been modified to be user-friendly and
add additional information for tracking data citation. A copy of these new forms is attached to this
notice. For each product, both forms will be available for public inspection once it is registered.
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. - ', • - ' 3 ; - ". '
a. EPA Form 8570-34, Certification with Respect to Citation of Data:
Form 8570-34 replaces Forms 8570-29 and 8570-31. Pesticide registrants must use
this form to indicate how they will meet their data submission/data citation
obligations under FIFRA, When a registrant refers to another company's data, it
must certify that an offer of compensation has. been made to the original data
submitter or that it has the original data submitter's permission to cite the data and
it must now indicate that it has evidence on file that an offer has been made or that
permission has been granted. It should be noted that Form 8570-34 does not replace
Form 8570-32, Certification of Offer to Cost Share in the Development of Data.
This form has been modified to.add four items: First, the names of the active
ingredients and/or representative test compounds are required at the top of the form.
Second the use pattern for the product is required. Third, the telephone number for
the applicant is required. And fourth, the applicant must indicate whether it is using
the cite-all method of support or whether it is using the selective method of suppbrt.
Also the form contains a brief description of the possible penalties for improperly
citing data. The form remains one page.
b. - EPA Form 8570-35, Data Matrix
The second revised form (8570-35), the data matrix, replaces the existing form
(8750-20) and the "Blue Book Sample Matrix Format." The data matrix must be-
used under the selective method. The matrix should also be used under the cite-all
method to indicate the companies to whom offers of compensation were made.
\ '
The revised data matrix, form provides more clarity regarding the information cited
by the applicant. To ensure consistency, these forms would be used for reregistration
as Well as registration and special review- The new form has completely revised
instructions. The instructions are designed to be user friendly, increase accuracy, and
reduce the time spent completing" the form.
There are two different copies of Form 8570-35. The "Public File Copy" and the
"Agency Internal Use Copy." The Agency Internal Use Copy is normally retained for
Agency use but is available by request under the Freedom Of Information Act. The
Public File Copy will not contain the guideline reference number, the guideline study
name, and the MRID number but will indicate the submitter and status of the data.
This version of the data matrix will be available for public inspection along with
, Form 8570-34, once a product is registered.
In the paper, chemical transfer, version of Form 8570-35, the second sheet is the
"Public File Copy." It has the columns for Guideline Reference Number, Guideline
Study Name and MRID Number blacked out so that this information is not
transferred from the top (Agency Internal Use Copy) sheet. The "Agency Internal Use
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Copy" or top sheet in the paper version and has the columns for Guideline Reference
Number, Guideline Study Name and MRID Number legible.
Important: If you are using the electronically available version of this form,.yoM must
submit both the "Public File Copy" and the "Agency Internal Use Copy." The forms
must be submitted in paper. The Agency cannot accept electronic submission.
The new Data Matrix, EPA Form 8570-35, provides a more detailed explanation of
how to fill out the form than the "Blue Book Sample Matrix Format" and Form
8570-20. Registrants are required to date and sign the form including their title. The
form will eliminate the return receipt to the registrant which reduces the Agency's
burden. The box requesting to be.on the DSL (Data Submitters List) is not on the
new form. Effective the date of this notice, registrants submitting data will
automatically be added to the DSL. If a registrant does not want to be added to the
DSL they must notify the Agency in writing at:
Office of Pesticide Programs 7504C [DSL]
U.S. Environmental Protection Agency
401MSt,S.W. , ,
Washington, D. C. 20460
It is the registrant's responsibility to verify that the information on the DSL is correct.
Corrections to DSL should be sent in writing to the above address.
The new Data Matrix will provide a clear indication of the information required, and
it will avoid confusion over when the "Blue Book Sample Matrix Format" should be
used as opposed to Form 8570-20. Further, original data submitters will find it easier
to ascertain if their data has been cited and whether or not they were purportedly sent
offers of compensation. Even though registrants will have more clarity using the new
Data Matrix, the amount of time needed to complete the form is the same as Form
8570-20 or the "Blue Book Sample Matrix format."
IV. EFFECTIVE DATE
Forms 8570-34 and 8570-35 should now be used for all registration, reregistration and
special review activities. Old Forms 8570-29, 8570-31, 8570-20 and "Blue Book Sample Matrix
Format" will not be accepted effective upon publication of this notice.
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V. ADDITIONAL INFORMATION ;
Electronic copies of Forms 8570-34 and 8570-35 ("Public File Copy" and "Agency Internal Use
Copy.") are available on the Internet at http://www.epa.gov/ opppmsdl/PRJVotices. The forms
are attached at the end of the PR Notice.
Paper copies of Forms 8570-34 and 8570-35: Please get these forms from our Internet site if you can.
If you do not have Internet access, paper copies can be requested from:
Registration Division
Office of Pesticide Programs (7505C)
U.S. Environmental Protection Agency . ..
• 401 M St, S. W.
Washington, D. C, 20460 '
Phone:(703)305-6549 . <' • >
If you have questions about the new data compensation forms, please contact your Agency
representative in the appropriate regulatory division or contact:
AlanDixon
Registration Division (7505C)
Office of Pesticide Programs,
U.S. Environmental Protection Agency
401M St, S. W. ' •>' --.
Washington, D. C. 20460
Telephone:. (703)305-7237 ' r
FAX: (703)305-6920
e-mail: dixon.alan@epaniail.epa.gov . •
For registered products, copies of submitted data compensation Forms 8570-34 and 8570-35 ( Public
File Copy only) are available for public inspection at:
U.S. Environmental Protection Agency ,
Office of Pesticide Programs '.
N ",. ' Public Regulatory Docket
Crystal Mall IIBuilding
1921 Jefferson Davis Highway-Room 119
Arlington, Virginia 22202 ''
(703) 305-5805
Jaines J. Jones,
'"2gistration Division.
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Electronic copies of EPA forms:
8570-34 ("Certification with Respect to Citation of Data")
8570-35 ("Data Matrix")
Important: In electronic format there are two different copies of form 8570-35 ("Data Matrix").
The "Public File Copy" has the columns for Guideline Reference Number, Guideline Study
Name and MRID Number blacked out. This is equivalent to the second sheet hi the chemical
transfer, paper, version where these columns are also blacked out so that information is not
transferred from the top sheet. The "Agency Internal Use Copy" is the same as the top sheet in
the paper version where the-columns for Guideline Reference Number, Guideline Study Name
and MRID Number are legible. If you are using the electronically available version of this form,
you must submit both the "Public File Copy" and the "Agency Internal Use Copy" to the
Agency.
• Only paper copies of the forms will be accepted at this time. Do not send electronic copies of
these forms to the Office of Pesticide Programs.
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Form Approved OMB No, 2Q7Q-QQ6Q
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
401 M Street, S.W.
WASHINGTON/D.C. 20460
Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 1.25 hours per response for
registration and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the .•
necessary forms. Send comments regarding burden estimate or any other aspect of this collection of information, including suggestions for reducing the
burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC 20460.
Do not send the completed form to this address.
Certification with Respect to Citation of Data
Applicant's/Registrant's Name, Address, and Telephone Number " .
Active Ingredients ) and/or representative test compound(s)
General Use Pattern(s) (list all those claimed for this product using 40 CFR Part 158)
EPA Registration Number/File Symbol
Date
Product Name
NOTE: If your product is a 100% repackaging of another purchased EPA-registered prdduct labeled for all the same uses on your label, you do not need to
submit this form. You must submit the Forrriulator's Exemption Statement (EPA Form 8570-27). • : -
Dl am responding to a Data-Call-in Notice, and have included with this form a list of companies sent offers of compensation (the Data Matrix form
should be used for this purpose).. . .... '
SECTION I: METHOD OF DATA SUPPORT (Check one method only)
ti
I am using the cite-all method of support, and have included with this
form a list of companies sent offers of compensation (the Data Matrix
form should be used for this purpose).
•D.
I am using the selective method of support (or cite-all option
under the selective method), and have included with this form a
completed list of data requirements (the Data Matrix form must
be used).
SECTION II: GENERAL OFFER TO PAY
[Required if using the cite-all method or when using the cite-all option under the selective method to satisfy one or more^ata requirements]
I' | I hereby offer and agree to pay compensation, to other persons, with regard to the approval of this application, to the extent required by FIFRA.
SECTION III: CERTIFICATION
I certify that this application for registration, this form for reregistration, or this Data-Call-in response is supported by all data submitted or cited in
the application for registration, the form for reregistration, or the Data-Call-in response. In addition, if the cite-all option or cite-all option under the selective
method is indicated in Section I, this application is supported by all data in the Agency's files that (1) concern the properties or effects of this product or an.;
identical or substantially similar product, or one or more of the ingredients in this product; and (2) is a type of data that would be required to be submitted
under the data requirements in effect on the date of approval of this application if the application sought the initial registration of a product of identical or
similar composition and uses .
I certify that for each exclusive use study cited in support of this registration or reregistration, that I am the original data submitter or that I have
obtained the written permission of the original data submitter to cite that study.
I certify that for each study cited in support of this registration or reregistration that is not an exclusive use study, either: (a) I am the original data
submitter; (b) I have obtained the. permission of the original data submitter to use the study in support of this application; (c) all periods of eligibility for .
compensation have expired for the study; (d) the study is in the public literature; or (e) I have notified in writing the company that submitted the study and
have offered (I) to pay compensation to the extent required by sections 3(c)(1 )(F) and/or 3{c)(2)(B) of FIFRA; and (ii) to commence negotiations to determini
the amount and terms of compensation, if any, to be paid for the use of the study. '•••'/.
I certify that in all instances where an offer of compensation is required, copies of all offers to pay compensation and evidence of their delivery in
accordance with sections 3(c)(1)(F) and/or 3(c)(2)(B) of FIFRA are available and will be submitted to the Agency upon request.' Should,! fail to produce sue!
evidence to the Agency upon request, I understand that the Agency may initiate action to deny, cancel or suspend the registration of my product in
conformity with FIFRA.
I certify that the statements I have made on this form and all attachments to it are true, accurate, and complete. I acknowledge that any
knowingly false or misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature , -
Date
Typed or Printed Name and Title
EPA Form 8570-34 (9-97) Electronic and Paper versions available. Submit only Paper version.
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Index of this Electronic Publication:
Page 1
Page 2-6
Page 7
PageS
Page 9
Page 10
This page
PR Notice 98-5
Form 8570-34
Form 8570-35
Form 8570-35
Form 8570-35
see guidance below
Agency Internal Use Copy*
Public File Copy*
Instructions
Electronic copies of EPA forms:
i - , • ' •
8570-34 ("Certification with Respect to Citation of Data")
8570-35 ("Data Matrix")
Important: In electronic format there are two different copies of form 8570-35 ("Data Matrix").
The "Public File Copy" has the columns for Guideline Reference Number, Guideline Study Name
and MRlD Number blacked out. This is equivalent to the second sheet in the chemical transfer,
paper, version where these columns are also blacked out so that information is not transferred
from the top sheet. The "Agency Internal Use Copy" is the same as the top sheet in the paper •
version where the columns for. Guideline Reference Number, Guideline Study Name and MRID
Number are legible. If you are using the electronically available version of this form, you must
submit both the "Public File Copy" and the "Agency Internal Use Copy" to the Agency.
Only paper copies of the forms will be accepted at this time. Do not send electronic copies of
these forms to the Office of Pesticide Programs:
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