2021 multi-state 25(b) audit announced
Multiple State Lead Agencies (SLAs) will be conducting an audit of all currently registered 25(b) pesticides in 2021. 25(b) pesticides, also known as Minimum Risk Pesticides, are a category of pesticides that US EPA has determined are unlikely to cause harm to man and the environment. As such, 25(b)s are exempt from the requirement to register under the Federal Insecticide, Fungicide and Rodenticide Act. Several states, however, do require the registration of 25(b)s and, with no federal review, these states take on the lead role for evaluating both the safety and the efficacy of these products.
Under the auspices of the Association of American Pest Control Officials (AAPCO), multiple states formed the FIFRA 25(b) Workgroup to address issues with 25(b) pesticides in a cohesive manner. The SLAs participating in this audit include Arizona, Indiana, Maine, Mississippi, South Dakota, Washington DC, and Wisconsin. The intent of the audit is to ensure that all currently registered 25(b)s meet the guidance published by the workgroup, which can be found on the AAPCO website.
The Office of the Indiana State Chemist (OISC) formally announced this audit in conjunction with the mailing of their year-end pesticide renewal notices. The announcement describes the following expectations and timelines for all 25(b) registrants:
1. Registrants must complete AAPCO’s fillable excel registrant document
2. The audit submission must include individual file folders for each product with:
a. Current market label in text searchable PDF format
b. Statement of formula
c. Efficacy data
d. Safety Data Sheets
e. Any available human health toxicity or hypoallergenic data
3. The excel document, along with the individual product files must be submitted no later than December 31, 2020 to all of the aforementioned SLA’s in compliance with the formatting and submission requirements outlined in the announcement.
States will conduct the audit and prepare findings during calendar years 2021-2022. Registrants will have calendar years 2023-2024 to address findings. Any products, for which findings were not addressed adequately, will not be eligible for renewal for sale and distribution in 2025.
How TSG can help
Our consultants have full knowledge of AAPCO’s 25(b) workgroup requirements and can assist with assembling all information for your audit submission. TSG can also assist registrants with the evaluation of available efficacy data to determine if it is robust enough to support all the desired label claims or if adjustments to those claims are advisable. In addition, we can negotiate with SLAs on their audit findings and provide possible alternative solutions that will benefit the registrant while satisfying the SLAs.