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In the United States, disinfectants used on environmental surfaces are regulated by the Environmental Protection Agency (EPA), under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA regulates disinfectants and sanitizers as pesticides, often referring to them as "antimicrobial pesticides." Prior to sale, disinfectants and sanitizers must be registered with the EPA as well as with all 50 U.S. States.
To register a disinfectant or sanitizer, companies must submit chemical characterization, safety, and efficacy data to EPA, as well as pay registration fees. Efficacy data should be generated in compliance with Good Laboratory Practice Regulations (GLP). Test methods used should be taken from the Series 810 guidance, and companies should consult EPA's Pesticide Registration Manual. Companies can also learn about disinfectant registration here.
Disinfectant and Sanitizer Testing Basics
EPA has long preferred so-called "hard surface carrier" methods for substantiation of efficacy claims. Test surfaces called carriers are inoculated, dried, and then treated with the disinfectant.
Some hard surface carrier methods are qualitative, meaning pass or fail determinations are made based on whether one or more test microorganisms survive treatment with a disinfectant. Other methods are quantitative, meaning percent reductions are calculated by counting viable microbial populations before and after treatment with the disinfectant.
Sanitizers are ordinarily tested using quantitative test methods such as ASTM E1153. The passing criteria depends on the method used and the label claim desired, but is typically a percent reduction such as 99.9%.
Disinfectants are tested using either the AOAC Germicidal Spray Products as Disinfectants Test (for spray products) or the AOAC Use-Dilution Test (for dilutable disinfectants).
Disinfectant and Sanitizer Test Methods
Disinfectant and Sanitizer Testing and Screening Methods (Cost-Effective and Quick)
Virucidal Disinfectant Testing Services
Microchem is one of the few labs in the country with a cell culture laboratory built to support virucidal efficacy testing. The laboratory also offers cost-effective screening for virus-killing activity of disinfectants using bacteriophage surrogates.
Algaecide Testing Services
Microchem Laboratory offers a wide range of testing services for antimicrobial pesticides, including AOAC, ASTM, EPA methods for disinfectant registration. In the eyes of the EPA, a disinfectant is a chemical product which kills or suppresses growth of pathogens and other microorganisms. Disinfectant products are assessed against a wide variety of microorganisms, both specified by various methods and supplemental. Disinfectants and sanitizers reduce the microbial contamination in schools, hospitals, public establishments, households, and industrial settings. Disinfectants come in various forms, including liquids, dilutable liquids, powder to be reconstituted, sprays, and wipes and have a variety of applications. For testing according to EPA standards, disinfectants are assessed for public health claims by use on hard, non-porous surfaces.
EPA Disinfectant claims are used for marketing of products. Many claims can only be made following registration with EPA, including such language as "Antibacterial," "Kills germs," "Prevents the spread of MRSA," "Kills 99.999% of germs," and other such public health claims. Naturally, these statements, when backed up by data, would give an edge to products and technologies which can make them, over those which do not have such claims.
Antimicrobial pesticides are registered with the appropriate agency through appropriate GLP testing, available at Microchem Laboratory. Different label claims require different test methods.
If you are interested in registering a disinfectant product or adding to label claims, you may also find EPA's disinfectant testing requirements or our list of available microorganisms helpful.
Microchem Laboratory also provides non-GLP testing for all methods, as well as screening for research and development purposes. These methods can not be used for agency registration of label claims, but they are cost effective and have relatively quick turnaround times, providing valuable data for customers who may still be formulating products or making changes to an established formula.