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Pesticide Registration Improvement Renewal Act (PRIA 2)
Fee Determination Decision Tree

Decision Tree Resources:
Below is the fee for your selected Fee Category for
Fiscal Year 2009 & 2010
Action Code
Description
Fee
(FY 09/ FY 10)
Decision Time
(months)
R311
 New product; requires approval of a new food-use inert; applicant-initiated; excludes approval of safeners
$16,317.00
FY 09
FY 10
12
12


Do you plan to request either of the following types of waivers?

50% waiver 50% waiver
75% waiver 75% waiver

To pay the fee shown above, go to http://www.pay.gov and follow the instructions.

Applications with a fee reduction request require a 25% payment due at application. Once the Agency determines the amount of the fee, you will be sent a bill or invoice for the balance due.

How to submit your application directly to EPA.


Action Code Interpretation: An application for registration for a new end-use pesticide product containing an active ingredient that is currently registered for the proposed food uses in the US.  The proposed formulation contains an inert ingredient that has not been approved for use on food use sites (refer to definition of food use).  The applicant requests the inert be granted a tolerance exemption or a tolerance.

The request for the new inert ingredient‘s tolerance or  tolerance exemption on food sites must include an application for registration of a new pesticide product.  All data (inert and end use product) and the petition and Notice of Filing (NOF) for the inert ingredient tolerance or tolerance exemption must be submitted with the application.  If a new product registration is not sought, then the request for food use inert tolerance falls outside of the scope of PRIA.

Approval of a safener does not fall within this category, but falls within the applicable new active ingredient category.

Data on the new food use inert ingredient:  OPP highly recommends the applicant request a meeting with the Inert Ingredients Assessment Branch (IIAB) staff prior to submission under PRIA to go over data needs.  Data to support the inert approval must accompany the application.

Inert ingredients are found in section 180.910 – 960 (plus some later sections).  [Note:  some internet browsers allow 40 CFR part 180 to be searched by the CAS number or name of the inert ingredient tolerance exemption.]  Also, a number of exemptions have expirations dates.  Therefore, click the links provided at the top of section 180.910 – 940 to find out the expiration dates.

All applications require the following:

  • A data matrix is required with the application.
  • Product chemistry data (Group A and B) unless the product is identical.  In some cases product chemistry data can be satisfied as outlined in Pesticide Registration Notice 98-1.
  • All other inert ingredients must already be approved for the applicable uses in the product.
  • Acute toxicity, efficacy, public health pest efficacy, companion animal safety data and/or child resistant packaging data requirements must be addressed by using: 1) the cite-all method, or 2) selective data citation which includes submitting the required data.  A rationale for a waiver or bridging of these data falls within this category.
Since this category requires both an application for the product and a petition to approve the inert ingredient, the entire package must be processed together.  If one part of the package fails (i.e., inert approval) then the application for the product also fails.  A change to the application would require the applicant to withdraw their application and petition and start the process application again.

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