Beveridge & Diamond
 

EPA Proposes New Efficacy Test Guidelines for Public Health Antimicrobial Products

Beveridge & Diamond, P.C., September 20, 2011

On September 15, 2011, the U.S. Environmental Protection Agency (“EPA”) made available for public comment a series of new draft efficacy test guidelines under the Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”) for antimicrobial pesticides that bear public health claims.  76 Fed. Reg. 57031 (Sept. 15, 2011).  Comments on the proposed guidelines must be received by EPA before December 14, 2011.

Unless otherwise exempted from regulation under FIFRA, products that make antimicrobial claims (which include claims to reduce or mitigate the growth of microbiological organisms, as well as claims to protect surfaces, processes, or water against contamination caused by bacteria, viruses, fungi, protozoa, algae, or slime) are considered pesticides that must be registered by EPA before they may be sold or distributed in the United States.  While EPA requires applicants to develop efficacy (i.e., product performance) data to support claims made for all antimicrobial and other pesticide products, EPA generally only requires the submission of efficacy studies from applicants that make public health claims in connection with their products.  40 C.F.R. § 400(e)(1). 

“Public health” antimicrobial products generally include those intended for use as sterilizers, disinfectants, or sanitizers on environmental surfaces.[1]  In 2010, EPA made draft efficacy test guidelines available for sterilants, hard surface disinfectants, and hard surface sanitizers.  75 Fed. Reg. 4380 (Jan. 27, 2010).  Those products subject to EPA’s newly published draft test guidelines include:

  1. water sanitizers, such as: (a) solutions, powders, or tablets intended for emergency disinfection of small quantities of drinking water of questionable potability; (b) products bearing claims for microbiological drinking water purification; and (c) disinfectants intended for use in swimming pools, spas, and hot tubs;
  2. air sanitizers intended for use in residential, commercial, industrial, hospital and medical environments (expressly including air sanitizers that contain at least 5% glycol); and
  3. fabric and textile disinfectants and sanitizers, such as: (a) laundry additive products intended for antimicrobial use in the pre-soak treatment of laundry or in household, hospital, or commercial laundry; (b) laundry additive products which bear claims to provide “residual” self-sanitizing activity on treated fabrics after use in automatic washing machines; (c) products intended for use as carpet sanitizers; (d) antimicrobial products used to treat mattresses, pillows, and upholstered furniture; and (e) fabric and textile surface sanitizer products.

The new draft guidelines describe test methods and procedures that will, according to EPA, “generally satisfy testing requirements” of FIFRA and the Federal Food, Drug, and Cosmetic Act (“FFDCA”).  Once final, EPA intends to incorporate these test guidelines into EPA’s data requirements for antimicrobial products, proposed by EPA on October 8, 2008.  In addition, EPA notes that these draft test guidelines may be incorporated into future regulatory actions taken by EPA under the Toxic Substances Control Act (“TSCA”).   

For more information about EPA’s proposed test guidelines or registration requirements for antimicrobial products more generally, please contact Kathy Szmuszkovicz at Beveridge & Diamond, P.C. (kes@bdlaw.com or 202-789-6037) or Alan Sachs, Independent Consultant Attorney (ajs@bdlaw.com or 410-230-1345).  For more information about EPA’s pending proposal to revise the data requirements for antimicrobial products more generally, please see B&D’s November 10, 2008 Alert, “EPA Proposes New Data Requirements for Antimicrobial Products.”  


[1] Sterilization claims made in connection with critical and semi-critical medical devices are separately regulated by the U.S. Food and Drug Administration (“FDA”) and excluded from regulation under FIFRA.  40 C.F.R. § 152.6(a).