Actions Not Covered by PRIA Registration Service Fees
There are many types of registration applications that are not subject to the decision time review periods and registration service fee requirements of PRIA 3. Examples include:
- Review of confirmatory data submitted in support of an already-issued registration (excluding efficacy data).
- Agency-initiated amendments (e.g., label amendments to comply with a reregistration eligibility decision).
- Submission of a sub-registrant/supplemental distributor label.
- Special Local Needs Registrations submitted under FIFRA Section 24(c).
- Adding minor crops to a crop grouping where no residue data are needed.
- Emergency Exemption Requests submitted under FIFRA Section 18.
- Notifications as described in Pesticide Registration Notice 98-10.
- Fast Track Amendments or label amendments that require no data review.
- Minor Formulation Amendments as described in Pesticide Registration Notice 98-10.
- 6(a)2 evaluations.
- Registrant responses to State Label Information Tracking System (SLITS) inquiries.
- The re-establishment of a time-limited tolerance.
If we determine that an application submitted without a fee belongs in a PRIA-covered category, we will send the application back to the applicant with a notice that the application is subject to a fee. The applicant must pay the appropriate fee and resubmit the application.
An example of this would be if a fast-track amendment, which would not normally require a fee, has been submitted for a change that requires data review. This is a covered pesticide registration category under PRIA 3 and requires a fee. The action must be submitted in a PRIA-covered registration category, with the appropriate fee.
According to FIFRA Section 24(c), "A State may provide registration for additional uses of federal registered pesticides formulated for distribution and use within the State to meet special local needs in accord with the purposes of [FIFRA] and if registration for such use has not been previously been denied, disapproved, or canceled by the Administrator. Such registration shall be deemed registration under [section 3] for all purposes of [FIFRA], but shall authorize distribution and use [only] within such State."
Because a 24(c) is equivalent to a section 3 for the uses within the state/s that granted the section 24(c), there is no fee to convert a 24(c) to a Section 3. Specifically, a registrant may choose to add 24(c) uses to its master label provided the directions for use on the label restrict the use to the state or states that have granted the Section 24(c) use. If the registrant proposes directions on the label allow uses that go beyond what was approved in the section 24(c) registration(s), then the application will be considered an application for a new use and will be subject to the appropriate PRIA fee.
Similarly, amending a label from regional use to national use would be considered a new use, subject to a fee.
- Applications submitted solely in response to an EPA reregistration or registration review, such as reregistration eligibility determinations (REDs) or risk management documents (RMDs), are not PRIA applications when they propose changes consistent with the RED or RMD. Therefore these applications are not subject to PRIA fees or deadlines.
- However, applications intended to respond to REDs or RMDs that do not conform to the Agency's decisions and requirements for the continued registration of the active ingredient and/or its products may be PRIA applications and may be subject to PRIA fees and deadlines. Examples of these type of registrant requests could include:
- Different risk mitigation language.
- Additional or different directions for use.
- Additional uses.
- Different pre-harvest intervals (PHIs) than specified by the Agency.
- Different or additional formulation changes.
- Changes in precautionary language.
- Advisory language not specified in the RED or RMD, etc.
When a minor, non-representative crop has been preliminarily determined by the Agency to belong to a crop grouping and no new crop specific residue data would be needed to establish a tolerance once tolerances have been established for the group, the regulation must be finalized or published in the Code of Federal Regulations before the crop will belong to the crop grouping. The crop grouping tables may be found in 40 CFR 180.41.
When the Agency’s preliminary decision has not been finalized through rulemaking at the time of the application’s submission, the request to add the minor use to a label will be classified as a new use subject to a new use fee. Understanding that less data will need to be reviewed because the data on the representative crop(s) will be used to establish the tolerance(s), the registrant may be eligible for a reduction in the fee of up to 75% when requesting an additional new use for such a minor crop.
Applicants should contact their registration ombudsman before submitting such an application and discuss their request for a fee reduction. The maximum that the Agency may reduce a fee is 75% of the fee published in the Congressional Record unless the fee is exempted (federal agency or state application, application solely associated with an IR-4 tolerance petition, or certain minor use application).
If a tolerance has to be amended as a result of the review of data submitted in fulfillment of a condition of registration, the applicant will need to submit a separate application and/or petition; these are covered PRIA actions. The applicant could request a discretionary refund under FIFRA Section 33(b)(8)(C) to take into consideration any data that was reviewed with another application.
An application to change a label from regional to national use would be classified as a “new use” consistent with the definition of new use in 40 CFR 152.3.
New use, when used with respect to a product containing a particular active ingredient, means:
- Any proposed use pattern that would require the establishment of, the increase in, or the exemption from the requirement of, a tolerance or food additive regulation under section 408 or 409 of the Federal Food, Drug and Cosmetic Act.
- Any aquatic, terrestrial, outdoor, or forestry use pattern, if no product containing the active ingredient is currently registered for that use pattern.
- Any additional use pattern that would result in a significant increase in the level of exposure, or a change in the route of exposure, to the active ingredient of man or other organisms.
Expansion of a use from regional to national meets the third criterion as it will result in a significant increase in the level of exposure to man and other organisms. Additional populations are exposed and conditions affecting the level of exposure may differ from one region to another (e.g., amount of precipitation, soil type, etc.).