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Hard Surface Disinfectants are regulated in the United States by the Environmental Protection Agency. The Agency has very specific requirements for testing, outlined in the "Series 810" guidelines.
In the United States, disinfectants and sanitizers intended for use on environmental surfaces must be registered with the Environmental Protection Agency (EPA). EPA regulates disinfectants as "antimicrobial pesticides," via the Antimicrobial Division, within the Office of Pesticide Programs. Jennifer McLain currently serves as director. EPA's Antimicrobial Division maintains a list of contacts. EPA gets its authority to regulate pesticides from the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
Navigating EPA's antimicrobial pesitcide regulation is challenging, especially for companies new to the process. Many companies use antimicrobial regulatory consultants. To get a recommendation for a good regulatory consultant, contact the lab.
EPA recommends specific tests using a specific reference microorganisms and product application techniques to substantiate disinfection claims. Those guidlines have been summarized by EPA in a series of documents referred to as "Series 810." Links are provided below:
- 810.2000 - General Considerations for Public Health Uses of Antimicrobial Agents (September 2012)
- 810.2100 - Sterilants--Efficacy Data Recommendations (September 2012)
- 810.2200 - Disinfectants for Use on Hard Surfaces-- Efficacy Data Recommendations (September 2012)
- 810.2300 - Sanitizers for Use on Hard Surfaces--Efficacy Data Recommendations (September 2012)
- 810.2400 - Disinfectants and Sanitizers for Use on Fabrics and Textiles (March 2013)
- 810.2500 - Air Sanitizers (March 2013)
- 810.2600 - Disinfectants and Sanitizers for Use in Water (March 2013)
- 810.2700 - Products with Prion-Related Claims (December 2012)
Companies intending to register disinfectants should be aware that EPA often requires aspects of studies to be conducted in a specific way, not always described in the existing Series 810 documents. Microchem stays up-to-date on EPA requirements and makes every effort to ensure that testing conducted at the lab is in compliance with their current preferences. EPA intends to update several of the documents in summer 2015. As those links become available, Microchem will update the list above.
Companies that intend to sell disinfectants and sanitizers in the United States must provide a great deal of data to the Agency prior to receiving registration. All data must be Types of data and ballpark cost figures are presented below:
- GLP chemistry data package to characterize active ingredient - $15,000
- GLP efficacy data package - $10,000 for most basic data, often companies run $50,000 to $100,000 worth of testing to support long lists of claims on labels.
- GLP toxicity data package - Unfortunately, EPA still recommends animal testing for most disinfectants sold in the U.S. Costs are typically around $20,000. Microchem does not conduct animal testing.
- Federal registration fees - Varies by entity size.
- State registration fees - Approximately $10,000 per year for all 50 states combined.
Once a company has registered a disinfectant, care must be taken to ensure that all claims made in marketing are in compliance with the EPA-approved "Master Label." If they are not, or if other FIFRA violations are observed, EPA may take enforcement action. EPA's enforcement is somwhat sporadic. Companies that receive enforcement action often receive large fines, which are catalogued and posted to the web.
Microchem Laboratory has been testing EPA-registered disinfectants since it was founded in 1988. If your company is interested in discussing registration of a new disinfecant, simply contact the lab for a free initial discussion. We are glad to share our resources and network with you to initiate your disinfectant registration.