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EPA Announces Updated Draft Efficacy Protocol for Copper Surface Sanitizer Products

For Release:  February 10, 2016

The U.S. Environmental Protection Agency initiated an external peer review of the updated draft protocol for testing the antimicrobial efficacy of copper-containing surface products. The testing described in this draft protocol is designed to support registration of copper-containing surface products (such as door knobs or other items that are not intended for food contact) that bear sanitizer claims. Based on public comments, numerous changes have been made to the draft, including changes to the test microbes, culture preparation, quality control process and product characterization.

Under the Federal Insecticide, Fungicide, and Rodenticide Act, EPA evaluates the efficacy of antimicrobial products intended to control pathogens that can be detrimental to public health. The products in question are hard surface copper-containing products such as door handles, light switch panels and bed rails. The copper-containing surface products are utilized for their antimicrobial characteristics.

Antimicrobial efficacy testing of copper-containing surface products presents many challenges because of the prolonged product life span, the likelihood that cleaning and disinfecting agents would be used on the surfaces and the wide variation in potential product forms and use patterns. This protocol is designed to address these issues by including a product characterization component that challenges the product’s physical durability and chemical stability when used as proposed. The efficacy assessment component of the protocol involves evaluation of the performance of two product manufacturing lots against two pathogenic microorganisms – Staphylococcus aureus and Pseudomonas aeruginosa. The efficacy test results, in combination with the product durability/stability component, will be used to determine the sanitizing activity of the copper-containing surface. Following completion of the external peer review, the Agency will evaluate the findings and revise the draft as appropriate prior to posting the final protocol.

For more information, go to: EPA’s Antimicrobial Pesticide Registration.

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