Indiana’s pending finalization of 25(b) audit update

Companies selling minimum risk pesticides in Indiana can expect to receive the results of the Indiana State audit by the first week of March. The Office of the Indiana State Chemist (OISC) is finalizing its review of the 25(b) audit update, and TSG's regulatory experts anticipate significant industry impact. Kelly Rahn, Executive VP of Business Development, notes, “Indiana will likely require widespread changes to 25(b) products. This will force registrants to divert internal regulatory staff away from business-critical activities to time-consuming, complex regulatory submissions that will provide no revenue growth. Whatever changes Indiana drives, registrants will need to update labels in 42 other states if the client wants one label for national distribution.” Rahn also adds:  “It is plausible that the audit review has caused delays in the issuance of new registrations in Indiana and, if that is the case, these delays will continue for the foreseeable future.” 

OISC is auditing all 25(b) products registered in Indiana. The stated reason for this audit is to ensure that older 25(b) products are up to current standards and, as such, the audit was limited to products registered in 2022 and older. Hundreds of products have been reviewed, and OISC intends to provide the results to registrants the first week of March.

Registrants will receive one document for each 25(b) product which will list the changes that must be made in order to maintain the registration. Changes may be required to labels, formulas, websites, SDSs and additional efficacy data may also need to be submitted for review. One particular call-out that could significantly disrupt the supply chain is that registrants will be required to prove that inert components in the formulas are not acting as active ingredients, if Indiana suspects something is amiss.

Registrants must submit their intent to make the revisions to OISC by September 1, 2024. The final revisions must be submitted by September 1, 2025, except for submission of additional efficacy data which will be given an additional 6 months. If OISC hasn’t received a response by September 1, 2024, Indiana will assume that the registrant does not intend to comply.

The products of registrants opting not to make the required revisions will be placed into one year of discontinuance for 2025. Distribution of these products into the state after December 31, 2025, will be considered sale of an unregistered pesticide for which a registrant may receive stop sale orders and fines.

TSG's regulatory experts specialize in navigating minimum-risk pesticides and guiding clients through state-level processes. We have a strong track record of successfully challenging states on their 25(b) interpretations and finding less onerous ways than are suggested by the state to satisfy their requirements. As participants in AAPCO's FIFRA 25(b) working group, we monitor changes and advocate for clients, in addition to frequent conversations with regulators which keeps us updated on changes as they happen.

Rather than diverting your staff away from activities that will grow your business, why not let TSG do the heavy lifting instead? We provide a range of support options from handling your tedious administrative tasks to engaging in complex negotiations with regulators on your behalf. Contact us for support during this Indiana audit or for any other regulatory needs you may have.