Checklists for 45/90 Preliminary Technical Screen
EPA uses these checklists to ensure that the application is ready for in depth review. Applicants can use them to help ensure their applications are complete. The applicant may submit the checklist with the application.
FIFRA section 33(f)(4)(B), “Initial Content and Preliminary Technical Screenings” directs the EPA to conduct a preliminary technical screen of the application. This screening is conducted no later than 45 days after the start of the decision review period for actions with decision review time periods equal to or less than 6 months and no later than 90 days after the start of the decision review period for actions with decision review time periods greater than 6 months. In conducting this technical screen, the EPA determines whether:
- the application and the data and information submitted with the application are accurate and complete, and
- the application, data and information are consistent with the proposed labeling and any proposed tolerance or tolerance exemption, and
- the application, data and information are such that subject to full review could result in the granting of the application.
If the application fails the technical screen, and the deficiencies cannot be corrected by the applicant within 10 business days after receipt of the EPA’s notification of the failure, EPA will reject the application. EPA uses the Fee Reduction Tables to determine the fee amount to be retained.
(the following are Microsoft Word documents)
- New Active Ingredient with Tolerances/1st Food Use (Word)(4 pp, 123 K)
- New AI Non-Food Use (Word)(4 pp, 111 K)
- New Product/Registered Source (Word)(4 pp, 108 K)
- New Product/Unregistered Source (Word)(4 pp, 118 K)
- Label Checklist (Word)(6 pp, 50 K)
- New AI with Tolerances (Word)(6 pp, 159 K)
- New AI Non-Food Use (Word)(4 pp, 107 K)
- New Product/Registered Source (Word)(5 pp, 123 K)
- New Product/Unregistered Source (Word)(5 pp, 127 K)