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Antimicrobial Testing Program
Current as of June 12, 2009
On This Page
- Program Overview
- Testing Results
- What if a Product Fails?
- Product Universe
- Collection of Products
- How Tests are Performed
- Next Steps
This Web page describes EPA's Antimicrobial Testing Program (ATP), summarizes program results, and lists products that have been tested. 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.
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. Other measures such as 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 tuberculosides since 1991 to help ensure that products in the marketplace meet stringent efficacy standards.
EPA collects and tests samples from manufacturers 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. This high standard was adopted by EPA to ensure that products will be effective even when extremely high pathogen levels are present.
The current focus of testing is on the "primary" registration of each disinfectant product formulation. The manufacturers of these primary registered products often contract with distributors, who then register products with identical formulas. Results of the testing program currently show that approximately two-thirds of the hospital disinfectants and half of the tuberculocides are fully efficacious when challenged at the highest bacterial challenge level. Those that have not met this high standard are brought into compliance through regulatory or enforcement measures, or a combination of both. The registrant may be required to reformulate, reduce the product claims, change the use directions or even cancel the product.
In rare instances, the Agency may determine that immediate enforcement action is appropriate, including stop sale orders and product recalls. The majority of products initially found not to be in full compliance with the efficacy performance standard have been brought into compliance using one of these approaches.
We are continuing efforts to complete testing of the initial group of products and are developing a long-term strategy for continued oversight of both the primary products and the larger group of distributor products.
Testing Results
Products tested through the ATP (26 pp, 163 K, About PDF). These include:
- 325 hospital disinfectants
- 72 tuberculocides
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.
Approximately two-thirds of the tested hospital disinfectant products and half of the tuberculocidal products have met EPA's post-registration efficacy standards.
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:
- Reformulation of the product and retesting by the manufacturer.
- Removal of hospital disinfectant or tuberculocidal claims from the product’s label.
- Modification of label directions (such as contact times) and retesting by the manufacturer following the new directions.
- Voluntary cancellation of the product by the manufacturer.
- 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 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.
In many cases, "primary" registered formulations are manufactured and sold by additional companies, called formulators or supplemental distributors. The registrant of each primary product must provide the product effectiveness data that supports tens and sometimes hundreds of "supplemental distributor" products.
Supplemental distributor products must be formulated identically to the primary product even though they are manufactured and sold by other companies. 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.
Sterilant testing was completed in 1993. In 1996, regulatory authority for certain liquid chemical sterilant products was transferred to the Food and Drug Administration under the Food Quality Protection Act amendments to FIFRA. For more information see FDA-Cleared Sterilants and High Level Disinfectants with General Claims for Processing Reusable Medical and Dental Devices.
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.
Collection of Products
The Agency uses a variety of means to collect product samples for testing. In the past, the Agency relied solely on collection by official federal or state inspectors. Due to issues with availability of product samples at production sites, the collection activities were expanded to include Internet purchases, direct shipment from the registrant or purchase from the marketplace. 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 request to the registrants is only intended to complete the initial testing, as EPA expects to return to the random testing of products. 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 specific methods for testing the effectiveness of hospital disinfectants and tuberculocides. The majority of methods are maintained and published by Association of Analytical Chemists (AOAC) International, a standard-setting organization. These same methods are used for post-registration evaluation in the ATP. 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.
Currently, EPA employs four laboratories to conduct ATP testing:
- Ohio Department of Agriculture/Consumer Analytical Laboratory
- North Carolina Department of Agriculture and Consumer Services
- Michigan Department of Agriculture/Laboratory Division
- EPA’s Office of Pesticide Program’s Microbiology Laboratory Branch
Next Steps
The Agency has set the end of 2011 as the goal for completing the post-registration evaluation of efficacy of the remaining hospital disinfectants and tuberculocides under the ATP.
In addition, EPA is developing an ATP Strategy that includes continued oversight of primary and distributor products. The strategy and implementation plan are scheduled to be completed in early 2010 and will be publicly available.