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Antimicrobial Testing Program
This Web page describes EPA's Antimicrobial Testing Program (ATP), lists products that have been tested and summarizes program results.
On This Page
- Program overview
- What products are tested?
- Testing results and actions for products that fail testing
- Submitting samples or data to support marketplace efficacy
- For more information
The Antimicrobial Testing Program ensures that EPA-approved hospital disinfectants and tuberculocides in the marketplace continue to meet stringent efficacy standards.
Under the ATP, we have 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. We adopted high standards 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 standards are brought into compliance through regulatory or enforcement measures.
The ATP tests:
- Registered hospital disinfectants.
- Products for use in dialysis facilities.
At the time of registration, the registrant of each primary product must provide efficacy data. A primary product may support tens or hundreds of “supplemental distributor” products. You can identify a product by the EPA registration number listed on the product label:
- The primary product carries a two-part EPA registration number – the first number is assigned to the company, the second number is unique to the product.
- A distributor product has a third number following the primary EPA registration number.
- For example, EPA registration Number 12345-12 is the primary registration number; EPA registration number 12345-12-2567 refers to a distributor product.
Under the ATP, primary or supplemental distributor products may be tested. The testing results are reflected under the primary registration number.
The List of ATP-tested Hospital Sterilants, Disinfectants and Tuberculocides identifies products that carry hospital disinfectant claims and have been tested or are pending testing in the program. We update the list periodically throughout the year.
Disinfectant products for use in the hospital environment are tested using standard methods. Disinfectants must be effective against both Staphylococcus aureus and Pseudomonas aeruginosa. In addition, products that have tuberculocidal claims must be effective against Mycobacterium bovis BCG. Agency-accepted standard methods and EPA standard operating procedures for ATP testing are available for the registration of each formulation type. Read more about EPA's standard operating procedures for ATP testing.
If a product does not meet post-registration efficacy standards under the ATP, we will determine the appropriate course of action to be taken. Options used individually or in combination to bring the product into compliance include:
- Removal of the hospital disinfectant or tuberculocidal claims from the product’s label.
- Voluntary manufacturer cancellation of the product registration.
- Removal of the product from the marketplace (i.e., stop sale orders) initiated by EPA.
Registrants have the option of voluntarily submitting data for liquid formulations that have been tested using the 2013 version of the AOAC Use Dilution Method for Testing Disinfectants. View the revised UDM methods and the associated performance standards.
For other formulation types such as spray and towelette products or for products with claims against Mycobacterium, registrants may voluntarily submit a product sample to EPA for testing.
If you decide to voluntarily provide a sample for testing, contact Susan Lawrence (firstname.lastname@example.org) at the OPP Microbiology Laboratory. Submit a copy of the:
- "Efficacy Test Conditions" form (DOCX)(2 pp, 22 K)
- Product label.
The laboratory will review the information and provide a date for submission of the sample.
Procedure for Product Sample Submission
Once you receive a date from the laboratory, follow the procedure outlined below.
The Agency requires a representative sample of the product that is packaged, labeled, and ready for release for shipment to the marketplace. In order to complete a formulation analysis and efficacy confirmation testing of hospital disinfectants, dialysis premise, and/or tuberculocidal claims, the typical quantities that are required for testing are noted below. If the sample is packaged in containers or volumes other than those noted below, indicate that in your email communication to the lab.
- Ready to Use (RTU) products: 2 gallons
- Concentrated Products: 4 quarts
- Aerosol Spray Products: 10 cans
- Towelette Products: 400 Wipes (in separate containers)
Ship samples consistent with the Department of Transportation (DOT) Hazardous Materials Regulations found at 49 CFR Parts 100-185. Include a company contact should issues arise during shipment. Registrants should maintain accurate batch and shipping records for all batches/lots chosen for evaluation.
Ship products to the following address:
Environmental Science Center
701 Mapes Road
Ft. Meade, Maryland 20755-5350
Attention: Michele Cottrill
Notify Michele Cottrill (email@example.com) upon shipment.
What EPA Does When We Receive Your Product Sample
The laboratory will conduct a formulation analysis of the sample. If the analysis indicates the product is within the appropriate limits, the sample will advance to efficacy testing. The laboratory will use the most current version of the applicable efficacy test method as outlined in the Product Performance Guidelines, OCSPP 810.2200, Disinfectants for Use on Hard Surfaces. View the OPP Microbiology Laboratory Standard Operating Procedures.
For products that pass both the chemistry and efficacy analysis, we will send the registrant a copy of the test reports. If a product fails to meet any of the performance requirements, we will contact the registrant concerning next steps.
For questions on the Antimicrobial Testing Program, contact John Cowden (Cowden.johnC@epa.gov) or (703) 347-0259.