Beverage and pharma producers beware: The U.S. Environmental Protection Agency (EPA) recently has shown an interest in enforcing the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), a law traditionally associated with chemical pesticides, against companies that manufacture and offer for sale in the United States products deemed to be “pesticide devices.” Alleging FIFRA violations against a supplier to the life sciences industry of aseptic filtration devices that reduce bioburden, the EPA focused on cartridges containing membranes used for filtration in “clean room” environments in research labs, pharmaceutical drug makers, and beverage companies. Some of the products considered to be FIFRA devices also were subject to regulation by the Food and Drug Administration. Pepper assisted the company in evaluating its operations and, as a result, the company took extraordinary measures to ensure compliance while meeting its supply obligations to its customers, and it agreed to settle the EPA’s allegations.
The case has noteworthy implications for pharmaceutical, life sciences and food and beverage companies. If the EPA pursues similar cases against other companies that produce pesticide devices, such actions could have a direct and substantial impact upon the supply chain for these businesses; since EPA’s enforcement authority includes stop-sale orders and seizures of non-compliant goods, non-compliant producers would have to consider self-imposed restrictions until compliance could be achieved.