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Antimicrobial Testing Program
Current as of May 11, 2012
This Web page describes EPA's Antimicrobial Testing Program (ATP), lists products that have been tested and summarizes program results. This information is provided to ensure that anyone using antimicrobial products has a full understanding of the scope and purpose of EPA’s Antimicrobial Testing Program.
On This Page
- Program Overview
- Testing Results
- What if a Product Fails?
- Product Universe
- Collection of Products
- How Tests are Performed
- Next Steps
Program Overview
Chemical disinfection of hard, non-porous surfaces such as floors, bed rails and tables is recognized as one component of the infection control systems in hospitals, food processing operations and other places where disease-causing microorganisms such as bacteria and viruses may be introduced or present. Frequent hand-washing, waste disposal and sterilization of instruments and devices are examples of other practices critical to infection control.
EPA's ATP has been testing hospital sterilants, disinfectants, and tuberculocides since 1991 to help ensure that products in the marketplace meet stringent efficacy standards. EPA’s Office of Pesticide Programs (OPP) has the responsibility under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) to regulate the registration of antimicrobial products used to control pathogenic bacteria, viruses and other microorganisms for a variety of uses. Under FIFRA, the registrant of a product with a public health claim is required to submit efficacy, or effectiveness data, to EPA in support of the product's registration. EPA reviews the effectiveness data as part of the registration process for each product. If the data meet efficacy standards and all other requirements for registration are met, the product qualifies for registration and is issued a distinct identification number, or EPA registration number, that appears on the product's label along with other required statements.
EPA collects and tests samples from manufacturers, stores or other places. The efficacy test methods provide a rigorous challenge to the product, as the level of bacteria used in the test(s) is at least 1,000 times greater than the contamination level typically found on surfaces in health care facilities. EPA adopted this high standard to ensure that products will be effective even when extremely high pathogen levels are present. Those that have not met this high standard are brought into compliance through regulatory or enforcement measures.
The Agency may determine that immediate enforcement action is appropriate, including stop sale orders and product recalls. The Agency is continuing efforts to complete testing of the initial group of products and is developing a long-term strategy for continued oversight of hospital disinfectants.
Testing Results
Disinfectant products with public health claims must be effective against both Staphylococcus aureus and Pseudomonas aeruginosa to meet Agency registration efficacy standards for use as a hospital disinfectant. Tuberculocidal products must also be effective against Mycobacterium bovis BCG.
This table provides the results of the agency's efficacy testing (PDF, 14 pp, 172.62KB About PDF). All hospital disinfectant products are grouped into three categories—“Agency Confirmed Efficacy,” “Agency Taking Action” and “Not Tested.” The first category, “Agency Confirmed Efficacy,” includes products that have passed ATP testing and are confirmed as efficacious hospital disinfectants. The second category, “Agency Taking Action,” includes products under Agency deliberation including actions such as performing additional testing or review and initiating regulatory or enforcement action. The third category, “Not Tested,” includes newly registered products that have not yet been tested (23 products) and products that, although registered, are not in production. Of those tested, the Agency has confirmed that 68% are efficacious. The Agency is taking action on the remaining 32% of tested products.
What if a Product Fails?
If a product does not meet post-registration efficacy standards under the ATP, 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 (e.g., stop sale orders.)
Product Universe
When the ATP was initiated in 1991, three categories of antimicrobial products were identified for post-registration evaluation:
- tuberculocides
- hospital disinfectants
- sterilants
These products were selected because public health care facilities use them to reduce the number of microorganisms on hard, nonporous surfaces as part of their infection control program. EPA is currently in the process of testing antimicrobial products with tuberculocidal and hospital disinfection claims.
The registrant of each “primary” product must provide the product effectiveness data that supports tens and sometimes hundreds of "supplemental distributor" products because in many cases, additional companies, called formulators or supplemental distributors, manufacture and sell "primary" registered formulations.
Supplemental distributor products must be formulated identically to the primary product even though other companies manufacture and sell them. These supplemental distributor products are issued their own EPA registration number that ties them to the primary registration. Taking into account the number of distributor registrations, the total number of registered hospital products is in the thousands.
Collection of Products
The Agency uses a variety of means to collect product samples for testing. Typically, the Agency collects samples via official federal or state inspectors. Due to issues with availability of product samples at production sites, the Agency has also initiated other collection efforts such as purchase from the marketplace, including internet purchases and direct shipment from the registrant. As an example, in December 2008, EPA issued a letter to the primary registrants requesting that samples of their liquid, spray or wipe products be shipped directly to the laboratories for testing. This voluntary submission was a special effort to accelerate the number of products coming into the program to be tested. Use of a variety of collection mechanisms helps ensure a continuous flow of products for testing and evaluation and that all products are ultimately tested.
How Tests are Performed
For the purpose of product registration, the Agency accepts data from studies performed according to specific methods for testing the effectiveness of hospital disinfectants and tuberculocides. The Association of Analytical Chemists International (AOAC), a standard-setting organization, maintains and publishes the majority of these methods. 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.
Next Steps
EPA is developing an ATP Strategy for future oversight of disinfectant products. As one step, the Agency is conducting a pilot study during FY 2012 that is focused on food contact sanitizers. A random sampling of sanitizers from the marketplace will be tested to determine if the products meet the label claims. The data from the study will be analyzed to determine whether additional scrutiny of this class of antimicrobials is warranted.