California’s Department of Pesticide Regulation (DPR) has released California Notice CA 2022-12 – Application Return Policy for Pesticide Product Registrations and Amendments, setting a new timeframe for responding to applications that are incomplete, inaccurate, or missing the required application fee.
This policy will go into effect on July 1st, 2022 and will limit the registrant to 15 business days to respond to any application deficiencies found by the Regulatory Scientist in their preliminary review. Per the policy, the DPR Regulatory Scientist will perform a preliminarily review of the submission to ensure it is complete and accurate. If an issue is found with the application or if any part of the submission is found to be missing, including the fee, the Regulatory Scientist will review the deficiency to determine whether it is able to be addressed in the 15-business day timeline. If the issue is able to be addressed within the time limit, the Regulatory Scientist will email the listed agent notifying them of the deficiency and giving them the opportunity to correct it. If the issue is not able to be addressed within 15 business days, the submission will be returned.
Ensuring your application is complete and accurate is vital to maintaining your spot in the queue for regulatory review and avoiding delays to registration of your product. SRC has a Quality Assurance Team that reviews all application documents before they are submitted to confirm that there are no deficiencies with the application and all required documents are included.
Additionally, DPR provides helpful guidance related to proper completion of submission documents at https://www.cdpr.ca.gov/docs/registration/references.htm.
What Deficiencies Can Be Addressed within the 15-Business Day Time Limit?
According to the notice, the following are examples of deficiencies that will be emailed to the registrant’s agent for correction within the 15-business day timeframe:
- Application errors
- Missing data
- Missing data references
- Missing application fee
- Six copies of the label not provided
- Illegible labels
- Missing EPA documents
- Missing agent letter of authorization
- Using an incorrect version of the application form
- Not providing content of proprietary blends in product formulations
If all deficiencies are fully addressed prior to the deadline, then the registration will maintain its place in the queue.
Any issue with the submission that is not resolved within the given timeframe will be returned. This includes additional deficiencies found in the corrected materials provided in response to the original deficiency notification.
What Deficiencies Will Lead to an Immediate Return?
- Any deficiency not corrected within 15 business days of notification
- Revisions requiring EPA approval
- Additional substantive changes that go beyond addressing the identified deficiency. ONLY the deficiency may be addressed during this time frame. Other label or formula changes may lead to return of the submission.
- Data not properly formatted according to DPR requirements
If a submission is returned, the registrant has 180 days to respond with all corrected items to avoid having to submit a new application package and pay the application fee again.
A returned submission will NOT maintain its place in the review queue and will be added to the back of the queue when resubmitted. Quick responses to any notifications from the Regulatory Scientist are key to keeping your estimated registration timelines on track and achieving your sale and marketing goals for your products.
Contact your SRC Regulatory Consultant for assistance with California DPR submission requirements and processing.