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EPA Antimicrobial Regulations

In the United States, the Environmental Protection Agency regulates the use of antimicrobials. Antimicrobial pesticides kill or stop the growth of fungi, viruses and bacteria. Antimicrobial products also protect surfaces and waterways from contamination from bacteria, viruses, algae and protozoa. According to the EPA, people spend more than one billion dollars annually on antimicrobial products.

  1. Types

    • The EPA regulates products used to control the growth of algae in water systems, in addition to products that treat infectious conditions in animals. Sterilizers, disinfectants, sanitizers and antiseptics must follow EPA regulations. Health-care workers depend on sterilizers hospital environments to clean medical equipment. People use disinfectants in health-care settings and in homes to destroy fungi and bacteria present on hard surfaces. Disinfectants include cleaning products that are used in pools and water purifiers. And people use sanitizers to clean hands, kitchen utensils and dishes. Antiseptics are used to prevent the spread or growth of microorganisms.

    Exceptions

    • EPA antimicrobial regulations do not cover the use of antimicrobials in medications for human consumption. In the United States, the Food and Drug Administration registers and approves antimicrobial human medications.

    Application

    • The EPA requires all new antimicrobial products to be registered under the authority of the Federal Insecticide, Fungicide and Rodenticide Act. Registrants must submit a statement to the EPA that contains a copy of the label of the product, directions of use and medical claims. The name of the pesticide should be included in the statement, in addition to the name and address of the person selling the drug. EPA antimicrobial regulations also require the pesticide to be classified as general use or restricted use.

    Fees

    • EPA antimicrobial regulations require an application fee to have a product considered for EPA approval. There are more than 140 fee categories. As of 2010, the submission of a new active ingredient for approval costs an applicant roughly $200,000. If an applicant submits a product that is similar to an existing product and contains EPA approved ingredients, the application fee is a relatively low $1,365. Small businesses may qualify for up to a 75-percent discount in application fees.

    Approval

    • The EPA may request samples of the antimicrobial product before final approval. The EPA usually approves products consisting of EPA-registered ingredients already on the market. The EPA will set the exact uses and dosage of the product. After a company has EPA approval for its product, the company may begin to use or sell the product. If the ingredients in an antimicrobial pesticide change, the EPA must reapprove the product.

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