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Registration Service Fees
Fee Inquiries

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Questions and Answers on:

Current as of September 2012

Questions and Answers on:

  1. We would like to convert our Section 24(c) into a Section 3 registration. Is there a PRIA fee for this application?
  2. Which applications are reregistration or registration review actions and not subject to a PRIA registration fee?
  3. The Agency has made a preliminary determination that a minor crop can be added to a crop grouping and it is a nonrepresentative crop for the crop grouping so crop residue data would not be needed to establish a tolerance. This preliminary determination, however, has not been finalized by rulemaking and therefore is not codified or published in the Code of Federal Regulations (CFR). Do I still have to pay the new use PRIA fee?
  4. When review of conditional data shows that a new tolerance(s) is needed or a tolerance level(s) needs to be amended, is this action a PRIA or non PRIA action?
  5. Our company currently has a use on a registered label that is restricted to certain regions of the US. We would like to amend it to a national use, for use throughout the US. How would such an application be classified under PRIA?
1. We would like to convert our Section 24(c) into a Section 3 registration. Is there a PRIA fee for this application?

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." Since a 24(c) is equivalent to a section 3 for the uses within the States with the section 24(c), there is no fee for converting a 24(c) to a Section 3. Specifically, a registrant may choose to add 24(c) uses to its master label provided the proposed uses on the label are restricted to the State or States with an appropriate Section 24(c). If the proposed directions on the label allow use 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.

2. Which applications are reregistration or registration review actions and not subject to a PRIA registration fee?

Applications submitted solely in response to EPA's reregistration or registration reviews, such as applications in response to reregistration eligibility determinations (REDs) or risk management documents (RMDs), are not PRIA applications and therefore are not subject to PRIA fees or deadline times. However, applications that do not conform to the Agency's decisions and requirements for the continued registration of the active ingredient and/or its products are new registration actions not associated with the RED or RMD or registration review. Examples of these type of registrant requests could include but are not limited to different risk mitigation language, additional or different directions for use, additional uses, different PHIs than specified by the Agency, different or additional formulation changes, changes in precautionary or advisory language not specified in the RED or RMD, etc. These examples are registration applications, some of which are subject to a PRIA fee.

3. The Agency has made a preliminary determination that a minor crop can be added to a crop grouping and it is a nonrepresentative crop for the crop grouping so crop residue data would not be needed to establish a tolerance. This preliminary determination, however, has not been finalized by rulemaking and therefore is not codified or published in the Code of Federal Regulations (CFR). Do I still have to pay the new use PRIA fee?

Yes, you will have to pay a fee. 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 crop still does not belong to the crop grouping until the regulation has been finalized or published in the Code of Federal Regulations (CFR). The crop grouping tables may be found in 40 CFR 180.41.

Because 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 prior to 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 or State application, application solely associated with an IR-4 tolerance petition, or certain minor use application).

4. When review of conditional data shows that a new tolerance(s) is needed or a tolerance level(s) needs to be amended, is this action a PRIA or non PRIA action?

It is a PRIA action. Agency review of the data submitted as a condition of a registration fulfills the condition of the registration. If a tolerance has to be amended as a result of the review, the applicant will need to submit a separate application and/or petition and 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.

5. Our company currently has a use on a registered label that is restricted to certain regions of the US. We would like to amend it to a national use, for use throughout the US. How would such an application be classified under PRIA?

The application 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:
  1. 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;
  2. Any aquatic, terrestrial, outdoor, or forestry use pattern, if no product containing the active ingredient is currently registered for that use pattern; or
  3. 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 impacting the level of exposure may differ from one region to another (e.g, amount of precipitation, soil type, etc.).

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