PRIA 3 Primary/Secondary (Related Applications)
Primary/secondary is a term used by the Office of Pesticide Programs for a number of situations in which one or more applications or registration actions are dependent upon or related to another action. In essence, these situations occur when a single review will serve to evaluate two or more related actions.
The categories under PRIA 3 group some of these actions together in one application for which one fee is charged. In other cases, the actions may fall under different categories, but a discretionary refund may be available for the dependent or secondary application. (Some of these situations were called parent/child relationships under PRIA 1.) The footnotes in PRIA 3 describe whether one fee or a reduced fee will apply to the secondary application. The footnotes are associated with the tables at Fee Schedule for Registration Applications.
Primary/secondary relationships along with submission requirements and fees associated with the secondary actions are described below for:
New Active Ingredients and First Food Use
The fee for an application to register a new active ingredient or first food use covers:
- any application to register the active ingredient’s technical (manufacturing use);
- up to four end use products; and
- any tolerance petitions submitted within the same application package.
In the case of a new active ingredient application, until the new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be deemed a new active ingredient.
In the case of a first food use application, until that first food use is approved, any subsequent application for an additional new food use or uses will be subject to the registration service fee and decision review time for a first food use.
If you submit information that we did not request to support the new active ingredient or first food use application after completion of the preliminary technical review, we will assess 25% of the registration service fee.
New Uses
The fee for the application is based on the number of new uses requested and includes:
- all label amendments to add the new uses to registered product labels; and
- the tolerance petitions submitted within the original application.
Any other amendment to a registered label besides adding the new use(s), its use directions and precautionary and advisory statements, is a separate registration action, subject to a separate fee for the corresponding PRIA category.
New Product Applications Submitted with New Use
If a new use application only proposes to register the new use for a new product and the application contains no amendment requests, review of the new product application is covered by the PRIA new-use fee. Any additional new products submitted in the same new use package are separate new product applications, each subject to an additional new product fee. (PRIA 3 changed how we handle new product applications; if you have questions about this, see the contact information below.)
If a new use application amends one or more registered labels to add that new use, then any new product application submitted in the new use package with a request to add that same new use is considered a separate application, subject to a separate new product fee.
To assist applicants in identifying the appropriate fee for a secondary action submitted with a new use, applicants should consult the table, New and Amended Product Applications Associated with New Use Requests, which also shows the Agency’s system for tracking and linking related new product applications. The timeframe for a secondary application that is submitted along with the primary application is the same as that of the primary decision.
New Products
Each new product application is subject to a PRIA fee. If one set of data or data waivers, excluding product chemistry, pertains to two or more applications and the data and applications are submitted simultaneously, a discretionary refund may be granted to reduce the fee(s) for the secondary application(s) in accordance with FIFRA Section 33(b)(8)(C) to take into account the decreased amount of work required to review them.
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 this application to go forward to review. Based on previous years of experience, EPA expects that it can grant a discretionary refund that will likely result in a reduced fee as indicated in the Primary and Secondary New Product Applications table. Where this chart indicates the expected fee is more than 25%, EPA recommends submitting the amount of the expected fee as listed in this chart along with a request for a refund to avoid delays in processing applications for which a complete fee has not been received.
To identify the likely fee for a secondary new product, applicants should consult the table, Primary and Secondary New Product Applications which also shows the Agency’s system for tracking and linking related new product applications. The timeframe for the secondary decision is the same as that of the primary decision.
If the new product application relies on data with another application such as an amendment, and the two applications are not submitted within the same application, each of these applications is treated as an individual, separate application with its own fee, start date, and due date. The applicant must reference the data in the other application(s) and may request the discretionary refund.
For More Information
- Questions on discretionary refunds should be directed to the registration ombudsman for the type of pesticide, i.e. conventional, antimicrobial or biopesticide.
- Consult the ombudsman when a product is submitted that contains two or more different types of active ingredients such as a biological or a biochemical active ingredient combined with a conventional active ingredient.
- For information on primary/secondary Plant Incorporated Protectant (PIP) applications such as stacked PIPs, consult the the Chief of the Microbial Pesticides Branch.