Q&A: Prioritization of 75-Day Letter Responses

On this page

1. What is a 75-day letter?
2. How does EPA prioritize applicant responses to 75-day letters?
3. Why does EPA prioritize review of applications in this manner?
4. Can an existing, accepted study be cited to resolve a data deficiency?
5. Will EOS still accept waiver requests when an applicant believes they can submit a waiver requests rather than conducting the required data?
6. If EPA denies a waiver request and issues a 75-day letter will EPA accept the submission of new studies to address the data that was originally waived?
7. Are there exceptions to this process?

---

1. What is a 75-day letter?

Under 40 CFR § 152.105, EPA may issue a 75-day deficiency letter to notify an applicant that its application is incomplete, and that it has 75 days in which to address the deficiencies within their pesticide application or provide a schedule for addressing the deficiencies. If, after 75 days, the applicant has not responded, or fails to address the deficiencies within the time scheduled, the Agency will treat the application as if it has been withdrawn by the applicant.

2. How does EPA prioritize applicant responses to 75-day letters?

EPA prioritizes responses to 75-day letters that provide existing raw data or other types of available clarifying information that address identified deficiencies. EPA’s Antimicrobials Division (AD) and Registration Division (RD) generally do not prioritize review of new studies (i.e., studies that were not included in the initial application) that are submitted to address deficiencies identified in 75-day letters, and generally do not renegotiate PRIA timeframes in order to do so. Under FIFRA Section 33(f)(5), renegotiation of a PRIA due date is contingent on mutual agreement between EPA and the applicant. The Biopesticides and Pollution Prevention Division (BPPD) generally prioritizes its work in a similar fashion, but may be more likely, on a case-by-case basis, to consider new or unique studies submitted in response to 75-day letters. This is due to the unique nature of active ingredients and data requirements reviewed by BPPD.

3. Why does EPA prioritize review of applications in this manner?

The Agency determined that, in most cases, renegotiation to allow for submission of new data is not the best use of its limited resources. In most instances where an applicant’s response to a 75-day letter includes new studies, EPA does not have sufficient time to review the new studies within the remaining PRIA decision time period. As a practical matter, submission of new studies in response to a 75-day letter usually results in a Do Not Grant decision from EPA because the Agency cannot review such studies before the PRIA due date and does not intend to renegotiate the due date to do so. Prioritizing review of correct and complete pesticide applications should further advance the Agency’s consistency and efficiency during the pesticide review process, lower the overall PRIA renegotiation rate, and benefit applicants who submit complete and correct packages at the time of submission.

4. Can an existing, accepted study be cited to resolve a data deficiency?

An applicant and the EPA reviewer handling the application can discuss whether citing an existing, accepted study would be appropriate for the action. However, citing an existing study would generally still require a second review by EPA. In these situations, EPA generally does not prioritize review of the newly-cited study or renegotiate the PRIA due date to do so.

5. Will EPA still accept waiver requests when an applicant believes they can submit a waiver request rather than conducting the required data?

Yes. An applicant may choose to submit a waiver request rather than a study meeting the Part 158 data requirement. Complete and scientifically supported waiver requests or data must be included with the initial application. To reduce the risk of a waiver request being denied upon EPA review, applicants are strongly encouraged to request a pre-application study waiver conditional ruling (PRIA codes A535, B614, or R124).

6. If EPA denies a waiver request and issues a 75-day letter, will EPA accept the submission of new studies to address the data that was originally waived?

If a waiver request is denied, AD and RD typically allow the applicant one written rebuttal to correct or amend the waiver request. This generally does not include the submission of new studies. If, after rebuttal, the waiver request remains denied, the associated data requirement would be unsatisfied, and EPA may accordingly issue a Do Not Grant decision in accordance with the review prioritization described above. On a case-by-case basis, BPPD may allow a new study to be submitted in response to a denied waiver request.

7. Are there exceptions to this process?

Yes, in some limited situations and on a case-by-case basis, EPA allows the submission of new studies to address deficiencies and may also, on a case-by-case basis, renegotiate PRIA due dates accordingly. If an applicant believes that submission or citation of new data should be allowed to address an identified deficiency, it should be discussed with the reviewer, Product Manager, and/or Branch Chief.