Enforcement Analytical Method Validation: 9 Parameters to Consider

The United States Environmental Protection Agency (EPA) requires registrants to provide toxicology data, antimicrobial efficacy data and product chemistry data to support the purported label claims for antimicrobial products designed to protect public health in the United States. As a part of the product chemistry data, the EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) requires registrants to provide an analytical method suitable for enforcement purposes for each active ingredient in the product and for each other ingredient or impurity that is determined to be toxicologically significant. The enforcement analytical method is maintained with the product registration and is used by the Agency whenever enforcement activities are performed on the product. As such, a thorough analytical method validation is paramount in preventing misinterpretation or misdirection during enforcement activities.

This white paper summarizes 9 key parameters that should be considered to ensure that the enforcement analytical method of an antimicrobial product intended for EPA registration is robust and scientifically sound.