1. Paperwork, Paperwork
How to Format Your EPA Submission
Presented by Karen E. Warkentien
Compliance Services International
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2. Contents of Application Package
EPA Administrative Forms
Cover Letter/Transmittal Document
Draft Label
Tolerance Petition (if necessary)
Studies (if necessary)
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3. 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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4. 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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5. 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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6. 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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7. 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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8. 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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9. 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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10. 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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11. 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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12. 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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13. 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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14. 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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15. 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
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