1. THE PESTICIDE REGISTRATION IMPROVEMENT EXTENSION ACT OF 2012 (PRIA 3) Impacts of PRIA 3 on Primary/ Secondary (Related Applications) Presented at: PRIA 3 Workshop April 10, 2013 By Susan Lewis Acting Director Antimicrobials Division

2. Primary/Secondary Related Applications 2  Primary/secondary is a term used by OPP for a number of situations in which one or more applications or registration actions are dependent upon or related to another action.  Some actions may be grouped together in one application for which one fee is charged and in other cases, a discretionary refund may be requested for the secondary action.  PRIA 1 used the term parent/child

3. New AI: Example of Primary/Secondary A new, food-use, active ingredient package is submitted with data, a technical product label, four end use product labels and a tolerance petition. 3 Type of SubmissionDescription of ActionPrimary or Secondary New Active Ingredient and 1 st Food Use Technical product & dataPrimary Tolerance petitionPrimary Up to 4 end-use productsPrimary Additional end-use products Secondary

4. New Uses: Primary/Secondary  The fee for a new use application is based on the type of uses in the application.  PRIA 3 footnotes explain how the Agency will handle applications submitted with a new use.  For new use packages that include label amendments only for already registered products, there is no limit on the number of products that may be amended. 4

5. New Uses continued 5  For new use packages that contain no label amendments (other than one for an existing technical product) and only one new product – the new product is covered by the fee for the new use.  For new use packages that contain both label amendments to registered products and one or more new products – the new products are considered separate secondary applications and will be charged the applicable new product fee.

6. New Use: Example of Primary/Secondary An outdoor, non-food, new use application is submitted with data to support 5 new uses and requests label amendments to add those new uses to the technical product and 6 registered end use products. 6 Type of SubmissionDescription of ActionPrimary or Secondary New Uses Amendment to add 5 new non-food uses to technical product label Primary Amendment to add 5 new, non- food uses to each existing end use product Primary New product applicationSecondary (requires additional fee)

7. New Products: Primary/Secondary  Each new product application is subject to a PRIA 3 fee;  Where one set of data/data waivers, pertains to two or more product applications that are submitted in the same package, the Agency refers to the product application containing the data as the primary application;  Additional new product applications submitted in the same package that rely upon the primary application’s data are referred to as secondary applications. 7

8. New Products: Example of Primary/Secondary 8 Type of SubmissionDescription of ActionPrimary or Secondary New Product New product application with data or data waivers (excluding chemistry) Primary Additional submission relying on primary data application for registration Secondary (requires an additional fee)

9. Amendments: Primary/Secondary 9  Under PRIA 2 if an applicant requested to amend a number of registered product labels with the same change and submitted a single set of data to support that change on the label, EPA considered all of the products submitted in that package as one request and charged a single PRIA fee.  Under PRIA 3, the categories have been codified in statute with footnotes that specify the scope of actions that are covered by the base fee for that category;  For some categories, the footnotes indicate that a category covers more than one action, e.g. a new active ingredient application includes up to five new products.

10. Amendments: Primary/Secondary (con’t.) 10  For other categories such as amendments, there is no footnote indicating that more than one action should be included as part of an application. The Agency interprets these categories, where no footnotes states otherwise, to cover only one action;  If an applicant requested to amend two or more registered products submitted in the same package with the same label amendment supported by a single set of data, the Agency would treat the amendment that includes the data as a primary application and the other amendments that rely on the data as secondary applications.  A discretionary refund, if requested by the applicant, would likely be granted for the secondary applications where the review of data for the primary application informs a decision on the secondary application.

11. Amendments: Primary/Secondary (con’t.) 11  In accordance with FIFRA 33(b)(2)(C), payment of at least 25% of the fee for the applicable PRIA category accompanied by a request for a refund of all or part of the remaining fee would allow these secondary applications to go forward into review.

12. Amendments: Example of Primary/Secondary 12 Type of SubmissionDescription of ActionPrimary or Secondary Amendment Amendment application with data or data waivers (excluding chemistry) Primary Additional submission relying on primary data application for amendment Secondary (requires an additional fee)

13. Primary/Secondary Related Applications 13  For Additional Information: Consult the “Primary and Secondary New Product Applications Submitted at the Same Time” Table on the PRIA 3 web page to determine the likely reduced fee for the secondary applications [www.epa.gov/pesticides/fees/; click on PRIA 3: Primary/Secondary (Related Applications)] link];

14. Questions Susan Lewis Acting Director, Antimicrobials Division Lewis.susan@epa.gov 14