BackgroundInks and coatings intended to provide antimicrobial/antiviral properties are regulated as antimicrobial pesticides by the Federal Environmental Protection Agency. Antimicrobial pesticides comprise a highly diverse group of pesticides that is distinctly different from conventional pesticides and biopesticides. Although they are subject to the same basic regulatory provisions of FIFRA as are conventional pesticides and biopesticides, antimicrobial pesticides are also specifically defined in FIFRA section 2(mm) and subject to additional registration requirements described in FIFRA section 3(h). In addition, antimicrobial pesticides are managed solely by the Antimicrobials Division (AD) of the Office of Pesticide Programs. This chapter provides additional guidance unique to antimicrobial pesticides that is not covered in the other chapters.
What is an Antimicrobial Pesticide?
- is intended to disinfect, sanitize, reduce, or mitigate growth or development of microbiological organisms; or
- is intended to protect inanimate objects, industrial processes or systems, surfaces, water, or other chemical substances from contamination, fouling, or deterioration caused by bacteria, viruses, fungi, protozoa, algae, or slime; and
- is exempt from or not subject to a tolerance…or a food additive regulation.
In general, antimicrobial substances used on inanimate surfaces are subject to FIFRA, whereas antimicrobial substances used in or on living animals or humans are subject to the Federal Food, Drug, and Cosmetic Act (e.g., human or animal drugs, antiseptics, liquid chemical sterilants used on medical devices, etc.). Some antimicrobial products are subject to both FIFRA and FFDCA (i.e., dual jurisdiction products) because they involve direct or indirect food uses, or use on food contact surfaces (see Use Patterns section below for uses that may be subject to both FIFRA and FFDCA). Also refer to FDA’s web site for a description of antimicrobial products that are subject to the FFDCA
NAPIM Bulletin on Antiviral Inks/Coatings