20000426 adminstrative documents for epa registration
TRANSCRIPT
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CSMA Workshop
Paperwork, Paperwork
How to Format Your EPA SubmissionPresented by Karen E. Warkentien
Compliance Services International
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CSMA Workshop
Contents of Application Package
EPA Administrative Forms Cover Letter/Transmittal Document Draft Label Tolerance Petition (if necessary) Studies (if necessary)
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CSMA Workshop
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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CSMA Workshop
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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CSMA Workshop
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