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Revised Data Requirements for EPA Registration of Antimicrobial Products

Wednesday, May 08, 2013
Sandler, Travis & Rosenberg Trade Report

The Environmental Protection Agency has issued a final rule that, effective July 8, will revise the data requirements for antimicrobial pesticide products to reflect current scientific and regulatory practice and provide clearer and transparent information about the data needed to support pesticide registration decisions for antimicrobial products.

Those who may be affected by this rule include importers of pesticide products, antifoulants, antimicrobial pesticides or wood preservatives. EPA sources state that this rule may result in more data requirements for some antimicrobial products but fewer for others, depending on the nature of the product and its use and exposure patterns. Potentially affected companies are encouraged to engage with the EPA to determine what specific tests and requirements may apply to their products.

Antimicrobial pesticides are used to control microbiological contamination in healthcare applications and deterioration in industrial, commercial and consumer products. Common public health antimicrobial products include sterilants, disinfectants and sanitizers. Non-public health products are sold and distributed for use to control the growth of algae, odor-causing bacteria, bacteria that cause spoilage, deterioration or fouling of materials, and microorganisms infectious only to animals. Other examples of non-public health products include products used in cooling towers, jet fuel, paints, and treatments for textile and paper products.

The EPA believes that the enhanced clarity and transparency of the information presented in the revised regulations will reduce uncertainty for applicants in generating and submitting data that is necessary for the EPA to be able to make registration decisions based on data-driven risk estimates that use fewer conservative assumptions. By fostering an understanding of which studies are needed to support the use of antimicrobial pesticide products, this final rule not only may save applicants time and money but should also allow such products to enter the market earlier.

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