Independent Review of EPA Antimicrobial Pesticide Efficacy Data

Antimicrobial pesticides (sanitizers, disinfectants, and sterilants) are statutorily required to demonstrate efficacy to support label claims against pests of public health significance. In recent years, EPA antimicrobial submissions have increasingly been rejected at the screening stage due to deficiencies. Rejections and withdrawals increase both time and cost to market, with withdrawals resulting in forfeiture of 25% of the PRIA fee.

Antimicrobial submissions may stall, fail, or trigger enforcement concerns for a range of reasons, including administrative deficiencies, missing documentation, incorrect or inappropriate testing parameters, unforeseen testing circumstances, labeling issues or noncompliance with EPA expectations.

I specialize in independent antimicrobial efficacy data review, providing tactical and strategic, pre- and post-submission scientific analysis to identify errors and gaps before they become regulatory obstacles. In addition to antimicrobial pesticides, I have experience reviewing data and labels for pesticide devices, treated articles, and FIFRA jurisdictional matters where efficacy support is required. 

My collaborative services are structured to be practical and efficient, emphasizing good value and timely availability.

My services support

• registrants filing independently, registrants using authorized agents or legal counsel; and

• consultants and legal firms, who may use my services as a behind-the-scenes supplement to their submission work.

Independent Non-GLP Device Lab Testing and Compliance checks

Support your pesticide device products with laboratory testing. All devices with claims against pests must be supported with data - I can help through protocol development, strategy (test vs. claim) and test execution. I also review labels, claims, packaging and whether the device is regulated under FIFRA (EPA). Mitigate any Stop Sale, Use, or Removal Order (SSURO) and keep your product on the market.

Please review the available services and reach out with any questions or specific requests.