Antimicrobial Testing Program
Current as of December 2014
This Web page describes EPA's Antimicrobial Testing Program, lists products that have been tested and summarizes program results.
On This Page
- Program Overview
- Testing Results [Updated November 2014]
- Qualifying for an “Agency Confirmed Efficacy” Designation
- What if a Product Fails?
- What Products are Tested?
- ATP Test Methods & Procedures
The EPA's Antimicrobial Testing Program ensures that EPA-approved hospital sterilants, disinfectants and tuberculocides in the marketplace continue to meet stringent efficacy standards. Under the ATP, the agency has collected and tested samples of EPA-registered products from manufacturers, distributors and sellers of hospital sterilants, disinfectants and tuberculocides. The ATP’s efficacy test methods provide a rigorous challenge to the product, as the level of bacteria used in the tests are at least 1,000 times greater than the contamination level typically found on surfaces in health care facilities. The EPA adopted this high standard to ensure that products will be effective even when extremely high pathogen levels are present.
Hospital sterilants, disinfectants and tuberculocides that do not meet the ATP standard are brought into compliance through regulatory or enforcement measures.
Current ATP ListThe List of ATP-tested Hospital Sterilants, Disinfectants and Tuberculocides (PDF) (26 pp, 200Kb) includes all products tested or pending testing in the program. According to Agency testing recommendations, disinfectant products for use in the hospital environment must be effective against both Staphylococcus aureus and Pseudomonas aeruginosa. In addition, hospital disinfectants that have tuberculocidal claims must be effective against Mycobacterium bovis BCG. Agency-accepted standard methods are available for the registration of each formulation type.
For questions contact John Cowden (703-347-0259 or cowden.johnC@epa.gov ).
To have a product designated as “Agency Confirmed Efficacy”, registrants should submit new efficacy data for their products; however, this is a voluntary exercise. For testing liquid formulations, the 2013 version of the AOAC Use Dilution Method for Testing Disinfectants should be used. The revised UDM methods and the associated performance standards are can be found at: http://www.epa.gov/pesticides/methods/atmpmethods/MB-05-12.pdf and http://www.epa.gov/oppad001/umd_performance_standard_revision_document.pdf.
Data Registrants Can Voluntarily Submit to EPA for Review.
Test the hospital disinfectant product following Agency testing guidelines, including all GLP-level requirements and the following criteria:
- Each microbe is tested against three product batches and each batch must be tested on a different day.
- All three batches should be tested at the lower certified limit (LCL) of the active ingredient(s). Testing at a single lab is acceptable. Thus, a total of three tests for S. aureus and three tests for P. aeruginosa are necessary. Sixty carriers are required per test, without contamination in the subculture media. For tuberculocidal claims, two product batches and ten carriers per batch are required.
- To be deemed an effective hospital disinfectant (or tuberculocidal), the product must meet the performance standard for all tested batches for the required microbe(s) based on the method utilized for testing.
- Use of the most current version of the test method is expected, and any modification to the procedure must be clearly noted. Modifications to a procedure should be verified by the Agency in advance of testing.
Submit the data to:
Mail: John Cowden
US EPA (Mail Code 7510P)
1200 Pennsylvania Ave, NW
Washington, DC 20460
If a product does not meet post-registration efficacy standards under the ATP, the EPA will determine the appropriate action to be taken. Options used individually or in combination to bring the product into compliance include:
- Removal of hospital disinfectant or tuberculocidal claims from the product’s label. The registrant must contact the agency to discuss options for relabeling the product.
- Voluntary manufacturer cancellation of the product registration.
- EPA initiates removal of the product from the market place (i.e., stop sale orders.)
The ATP tests registered hospital disinfectants, products for use in dialysis facilities and tuberculocides. At the time of registration, the registrant of each primary product must provide product efficacy data that supports tens and sometimes hundreds of "supplemental distributor" products. Supplemental distributor products may be tested, however, these distributor products are represented by the primary registration number on the ATP list. Distributor products frequently use different brand names, but the EPA Registration Number (Reg. No.) of a product is more useful than its brand name for identifying the primary EPA-registered product.
You can identify distributor products by their three-part EPA Reg. No. The first two parts of the EPA Reg. No. identify the company number assigned to the primary EPA registered product and the product number. A third set of numbers represents the Distributor ID number. For example, EPA Reg. No. 12345-12-2567 is a distributor product for the primary product with EPA Reg. No. 12345-12.
The ATP test methods and procedures are based on standards maintained and published by the Association of Analytical Chemists International, a standard-setting organization. The challenge microorganisms used to determine the effectiveness of hospital disinfectants are Staphylococcus aureus and Pseudomonas aeruginosa, and for tuberculocides, Mycobacterium bovis BCG. Read more about EPA's standard operating procedures for ATP testing.
The agency will be using the revised (2013) performance standard for the AOAC Use-dilution Methods (PDF) (3 pp, 105 k, About PDF) for Staphylococcus aureus (955.15) and Pseudomonas aeruginosa (964.02).