Description and Usage of Antimicrobial Products

Antimicrobial agents are substances or mixtures of substances used to destroy or suppress the growth of harmful microorganisms whether bacteria, viruses, or fungi on inanimate objects and surfaces. Antimicrobial products contain about 300 different active ingredients and are marketed in several formulations: sprays, liquids, concentrated powders, and gases. Today, approximately one billion dollars each year are spent on a variety of different types of antimicrobial products. More than 8000 antimicrobial products are currently registered with the U.S. Environmental Protection Agency (EPA) and sold in the marketplace. Nearly 50% of antimicrobial products are registered to control infectious microorganisms in hospitals and other health care environments. However, public health antimicrobial products tend to be low-volume products, and thus constitute less than 5% of the estimated total market for antimicrobial products.

Types of Antimicrobial Products

Antimicrobial products are divided into two categories based on the type of microbial pest against which the product works. Non-public health products are used to control growth of algae, odor-causing bacteria, bacteria which cause spoilage, deterioration or fouling of materials and microorganisms infectious only to animals. This general category includes products used in cooling towers, jet fuel, paints, and treatments for textile and paper products. Public health products are intended to control microorganisms infectious to humans in any inanimate environment. The more commonly used public health antimicrobial products include the following:

Sterilisers (Sporicides): Used to destroy or eliminate all forms of microbial life including fungi, viruses, and all forms of bacteria and their spores. Spores are considered to be the most difficult form of micro-organism to destroy. Therefore, EPA considers the term Sporicide to be synonymous with "Steriliser." Sterilisation is critical to infection control and is widely used in hospitals on medical and surgical, instruments and equipment. Types of Sterilisers include steam under pressure (autoclaving), dry heat ovens, low temperature gas (ethylene oxide), and liquid chemical sterilants. Gaseous and dry heat Sterilisers are used primarily for Sterilisation of medical instruments. Liquid sterilants are primarily used for delicate instruments which cannot withstand high temperature and gases.

Disinfectants: Used on hard inanimate surfaces and objects to destroy or irreversibly inactivate infectious fungi and bacteria but not necessarily their spores. Disinfectant products are divided into two major types: hospital and general use. Hospital type disinfectants are the most critical to infection control and are used on medical and dental instruments, floors, walls, bed linens, toilet seats, and other surfaces. General disinfectants are the major source of products used in households, swimming pools, and water purifiers.

Sanitisers: Used to reduce, but not necessarily eliminate, micro-organisms from the inanimate environment to levels considered safe as determined by public health codes or regulations. Sanitisers include food contact and non-food contact products. Sanitising rinses for surfaces such as dishes and cooking utensils, as well as equipment and utensils found in dairies, food-processing plants, and eating and drinking establishments comprise the food contact Sanitisers. These products are important because they are used on sites where consumable food products are placed and stored. Non-food contact surface sanitizers include carpet sanitisers, air sanitisers, laundry additives, and in-tank toilet bowl sanitisers.

Antiseptics and Germicides: Used to prevent infection and decay by inhibiting the growth of microorganisms. Because these products are used in or on living humans or animals, they are considered drugs and are thus approved and regulated by the Food and Drug Administration (FDA).

EPA Regulation of Antimicrobial Products

EPA registers and regulates antimicrobial pesticides under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). To obtain registration, manufacturers of antimicrobial products must meet the basic standards, the foremost being: 1) that the product will not cause unreasonable adverse effects to human health or the environment, and 2) that product labeling and composition comply with the requirements of FIFRA. Moreover, manufacturers are required to submit to EPA detailed and specific information concerning the chemical composition of their product; effectiveness data to document their claims against specific microorganisms and to support the directions for use provided in labeling; labeling that reflects the required elements for safe and effective use; and toxicology data to document any hazards associated with use of the product.

Recently, increased concern has emerged regarding whether public health products used to kill microorganisms pathogenic to man on inanimate surfaces and objects in hospitals, schools, restaurants, and homes work as claimed on the label. The private and public sector communities, including competitor registrants, have made the Agency aware of Sterilisers and hospital disinfectants which may be ineffective. EPA has responded to this situation by developing a comprehensive strategy to improve the regulation of antimicrobial pesticides

Since public health products are crucial for infection control, and because of the increased controversy regarding product effectiveness, the Agency is conducting pre-registration confirmatory and post-registration enforcement testing of certain public health products. More specifically, EPA has entered into an Interagency Agreement with the FDA, and is jointly testing all sterilants except gases (registered and those seeking registration) and registered products which make unsubstantiated claims of controlling the bacterium which causes tuberculosis (including sterilants and hospital disinfectants). These two types of public health products are the most crucial to infection control and their failure could pose grave danger to the public and the medical community.

Furthermore, EPA has greatly improved communications with the public, all levels of government, academia, user communities, industry, health professionals, trade organizations, and independent testing groups. Also, EPA has committed funds to ensure that the tests used to demonstrate the efficacy of antimicrobial products are reliable and reproducible; is in the process of developing a complaint system to handle concerns regarding ineffective products; amplified internal controls to ensure the integrity of data submitted by registrants; and is currently publishing a quarterly newsletter designed to educate the general public about the status and direction of the regulation of antimicrobial products. The Agency is actively working to ensure that all antimicrobial products sold and distributed in the marketplace are effective in protecting public health and the environment from potential health risks.

The previous EPA regulation may have changed due to the passage of FQPA.

1 An inanimate object or surface does not have the qualities of a living organism. Antimicrobial agents used on inanimate objects and surfaces are regulated as pesticides by EPA. Products intended for the control of fungi, bacteria, viruses or other microorganisms in or on living humans or animals are considered drugs, not pesticides, and are therefore regulated by the U. S. Food and Drug Administration (FDA). See 40 CFR 152.5(d) and 152.8(a).