Product Comparator: Registration guarantees effectiveness in disinfectants and sporicidal agents
12/01/1999
Laureen Belleville
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If your application requires a product that kills microorganisms, then you need a disinfectant or sporicidal agent that is registered with the EPA. In fact, according to Jeanne M. Fox, EPA Region 2 Administrator, "Unless a product is registered as a pesticide with the EPA, it is not formally recognized as effective. People and institutions should not buy products claiming to disinfect surfaces unless an EPA registration number appears on the label."
RIGHT. Veltek's Decon-ahol sterile WFI formula.
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The EPA is concerned that institutions will use unregistered products that make antimicrobial claims in the expectation that they will disinfect or sanitize. If the products failed to disinfect, people could be injured, and the institution might be held responsible. In an effort to reduce this risk to public health, EPA has targeted ineffective antimicrobials as a national priority and will pursue enforcement actions against companies for making such claims.
RIGHT. Steris' LpHse acid phenol disinfectant. END General cleaning agents, however, do not require EPA registration.
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 that the product will not cause unreasonable adverse effects to human health or the environment and that product labeling and composition comply with the requirements of FIFRA. Moreover, manufacturers are required to submit to EPA detailed information concerning the chemical composition of their products; 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 hazards associated with the use of the product.
There is a hierarchy of efficacy for the products and how they are regulated: "The difference between 'sanitize' and 'disinfect' is the degree," explains Yvette Hopkins, EPA ombudsman and outreach team leader. She further explains that "liquid chemical sterilant products that are intended for use on critical or semi-critical devices [items that come in contact with the blood stream or mucosa] are not regulated as 'pesticides' by the EPA but as 'medical devices' under the regulatory authority of the Food and Drug Administration (FDA)." And she warns that different states may have additional regulations.
Validation of sanitizing agents can be accomplished in a variety of ways. Typically manufacturers will conduct either an in vitro evaluation, an in situ evaluation or perhaps both when evaluating disinfectant efficacy. The EPA and FDA ask for evidence that disinfectants work as expected in actual application. Therefore, in situ evaluation or field studies are increasingly common. These activities can be costly and time consuming for the manufacturer. Once a product is EPA registered it costs about $1600 per year to maintain registration. Companies that register with the EPA are assigned two numbers: one for the company and one for the product. Hopkins at EPA advises buyers to get these numbers from the vendor. "But don't stop there," she warns. "Call the EPA to check that they are valid numbers. There have been instances where unregistered companies have 'made up' numbers for buyers."
We've included the EPA registration number for the companies listed in our table. Readers can get more information on the products by contacting the manufacturers as listed or the EPA at (703) 308-6214; Fax: (703) 308-6466. Or contact the National Anti-Microbial Information Network at Oregon State University, (800) 447-6349, ww.ace.orst.edu/info/nain.
Download file to view table.
Glossary of terms
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.
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.
Sanitizers: Used to reduce, but not necessarily eliminate, microorganisms from the inanimate environment to levels considered safe as determined by public health codes or regulations. Sanitizers include food contact and non-food contact products.
Sterilizers (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 the most difficult form of microorganism to destroy. Therefore, EPA considers the term 'sporicide' to be synonymous with 'sterilizer.' Sterilization is critical to infection control. Types of sterilizers include steam under pressure (autoclaving), dry heat ovens, low-temperature gas (ethylene oxide), and liquid chemical sterilants. Gaseous and dry head sanitizers are used primarily for sterilization of medical instruments. Liquid sterilants are primarily used for delicate instruments that cannot withstand high temperature and gases.
Source: EPA