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Paperwork, Paperwork

How to Format Your EPA SubmissionPresented by Karen E. Warkentien

Compliance Services International

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Contents of Application Package

EPA Administrative Forms Cover Letter/Transmittal Document Draft Label Tolerance Petition (if necessary) Studies (if necessary)

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EPA Form 8570-What?

EPA Forms– Application for Pesticide Registration/

Amendment (EPA Form 8570-1)– Confidential Statement of Formula (EPA Form

8570-4)– Notice of Supplemental Distribution of a

Registered Pesticide Product (EPA Form 8570-5)

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EPA Form 8570-What?

EPA Forms (cont.)– Formulator’s Exemption Statement (EPA Form

8570-27)– Certification with Respect to Citation of Data

(EPA Form 8570-34)– Data Matrix (EPA Form 8570-35)

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Which Forms Do I Need?

Distributing a Registered Product– Supplemental Distribution Form

• Signed by the primary registrant and the distributor

• Once mailed to EPA, the registration is effective

• No other documents required

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Which Forms Do I Need?

Formulating from a Registered Source– Application Form

• Basic product and contact information

• Substantially-similar (“me-too”) fast track review– Allows for faster review of new products that are identical

or very similar in composition to an already registered product.

– Confidential Statement of Formula• Lists ingredients in the product in weight percent

• Proprietary “recipe” for production

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Which Forms Do I Need?

Formulating from a Registered Source (cont.)

– Formulator’s Exemption Form• Lists registered source material• Exempts registrant from conducting/citing generic

active ingredient testing

– Citation of Data Form/Data Matrix• Required when data are submitted and/or cited

– Need to offer to pay compensation when citing data generated by others

– Matrix lists studies registration application relies on

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Which Forms Do I Need?

Formulating from an Unregistered Source– Application Form– Confidential Statement of Formula– Certification with Respect to Citation of Data

• Methods of Support– Cite-All Method

– Selective Method

– Cite-All Option under the Selective Method

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Which Forms Do I Need?

Formulating from an Unregistered Source– Data Matrix

• List all guideline requirements and data submitted and/or cited

• Two versions– Agency Copy

» All information about the cited studies is provided

– Public Copy

» Guideline reference, study name, and MRID number are blacked out

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What’s in a Letter?

Cover Letter– Accompanies package and directs submission

to the proper product manager (if known)– Identifies the type of submission– Provides company contact information– Can be combined with transmittal document

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What’s in a Letter?

Transmittal Document– Required when data are submitted– Identifies the studies submitted

• Volume number

• Guideline reference

• Study title/Laboratory/Author/Date

– Can be incorporated into the cover letter

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Labeling

Draft label– Guidance Documents

• Regulations in 40 CFR § 156.10

• Label Review Manual

• PR Notices

– Provides use directions for the product– Includes information about human health,

environmental effects, product composition– Five (5) copies required

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Tolerance Petitions

When Required– If proposed use results in residues in/on food

commodities and no tolerance or exemption has been established

What’s Required– Tolerance petition per 40 CFR § 180.7– Data to support tolerance/exemption– $$$$$

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Data Submission and PRN 86-5

PR Notice 86-5– Established formatting guidelines for all studies– Requires basic information about the following

• Data submitter/Laboratory/Guideline

• Confidentiality of data

• Good Laboratory Practice (GLP) compliance

• Flagging of toxic effects (for some toxicology studies)

– Three (3) copies of each submitted study

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Data Submission and PRN 86-5

PR Notice 86-5 (cont.)– EPA front-end review

• Assigns MRID numbers to studies that comply– Master Record Identification numbers

• Rejects noncompliant studies– Not assigned MRID numbers

– Notice of noncompliance states deficiencies

– Rejected studies returned to registrant for reformatting

– Must be resubmitted with new transmittal document