A common theme of 2024 is extended processing timelines for pesticide product reviews and approvals at both the Environmental Protection Agency (EPA) and California Department of Pesticide Regulation (DPR). There are many factors leading to the current Agency timelines for all submission types.  A large backlog of actions coupled with resource constraints (personnel and budgetary) have contributed to these longer processing times.

SRC recognizes this is disruptive to business plans and works to make submission processing as efficient as possible.  Many of the factors surrounding these delays are out of a registrant’s control, other than lobbying your representative for increased agency budgets. However, quality packages are in your control and one of the most effective tools to help close an action when your submission package reaches the top of the queue.  Here are our top 5 tips to avoid deficiency notices which add time to receiving your approval:

 

  1. Provide a robust cover letter that explains how all the requirements (administrative, data, labeling) are met. Include support for classification of the submission type.
  2. Review your Confidential Statement of Formula carefully, even if previously approved.  There could be hidden landmines in the source materials.
  3. Ensure all the fields in the administrative and application forms are complete and consistent with one another. Deficiency letters can be issued for typos and transcription errors in the administrative forms.
  4. Review your label carefully for typos and clarity.  Small label errors can be mistaken as an unintended marketing claim that may require additional data. SRC reviews your label for potential claims issues that could arise during the Agency review and will notify you of those in advance of filing.
  5. Format study volumes properly with complete signatures, pagination, identification and legibility.

 

We strive for excellence in our Agency submissions at SRC, with a Quality Assurance review conducted on every package that leaves our hands.  We are available to submit actions on your behalf, prepare your packages for your direct submission, or provide a quality review.  SRC can also help you preserve Agency resources by drafting your efficacy Data Evaluation Record (DER) to include in the submission. This allows the Agency to focus on their review rather than data entry.

We understand that every day, week, and month that your submission is under review means lost sales for your company. Give yourself the best chance at success and let us know how we can help!

 

 

 

 

Rebecca Mannion

Federal Regulatory Team Assistant Manager

Posted on: 10/04/2024