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Regulating Antimicrobial Pesticides

Many of the laws, guidance, and policies that govern EPA are contained in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Exit EPA disclaimer as Amended in 1996, 40 Code of Federal Regulations (CFR) Parts 152, 156 and 158 (includes current regulation & proposed revisions), and the Office of Pesticide Prevention and Toxic Substances (OPPTS) Harmonized Test Guidelines. The additional guidance needed for antimicrobials can be found in the links for efficacy test guidelines, antimicrobial policy questions, and other antimicrobial guidance. See specific antimicrobial laws and guidance documents below:

  1. Registration Policy Documents - list of policy and guidance documents to assist in registering or understanding antimicrobial products
  2. Disinfectant Technical Science Section (DIS/TSS) Documents - for determining efficacy data requirements, label claims, and in some cases testing requirements

Antimicrobial Registration

EPA regulates pesticides under the statutory authority of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The registration requirements for antimicrobial pesticides differ somewhat from those of other pesticides. For example, EPA requires special tests to ensure efficacy of public health pesticides when the pests are invisible disease-causing microbes, rather than insects or rodents that may be harboring disease organisms. Similarly, determining human and ecological risks from exposure to antimicrobial pesticides requires different types of measurements and models than those needed for pesticides largely applied to crops and other plants. In view of these and other differences, EPA decided that its regulations governing pesticide registration requirements should also incorporate special antimicrobial sections. For more detailed registration information please see the following:

  1. Registration Kit (Basic Instruction & Forms)
  2. Label Review Manual (178 pp, 3MB About PDF),
  3. Antimicrobial Pesticide Registration (PR) Notices
  4. Registration Policy Documents

Antimicrobial Reregistration

The process of reregistration involves determining the "eligibility" of the active ingredients (a.i.) for all pesticides originally registered before November 1, 1984. These pesticides must be supported with a complete scientific analysis and show that they can be used without causing unreasonable adverse effects to human health or the environment. EPA is responsible for the development and issuance of Reregistration Eligibility Decision Documents (REDs) for all chemicals with mainly antimicrobial uses. The RED document formally present the Agency's evaluation of the data base supporting the reregistration of a pesticide (conclusions regarding which uses are eligible for reregistration under specific condition and requirements etc.). The Antimicrobial Reregistration Status page contains the list of the antimicrobial REDs, their schedules, and completed documents and available fact sheets.

Antimicrobial Registration and Reregistration Workplans

Issued yearly, these workplans detail the registration of new pesticide active ingredients or new uses of antimicrobial pesticides, reregistration of antimicorbial pesticides, and special projects that are planned activities for the Office of Pesticide Programs for the stated fiscal year.

Antimicrobial Health & Safety

Antimicrobials play an important role in public health and safety. While providing health benefits of pathogen removal and, in some cases, safety benefits of materials preservation, they also involve risks of potential efficacy failure and exposure hazards. It’s no wonder, then, that the effectiveness and proper use of these products are of widespread concern. See the following documents for further reading:

Related Resources

There are several resources outside of the EPA Web site which may give readers additional antimicrobial information sources and opinions, which are not currently located as part of the this section of the EPA Web site. Links outside EPA are not necessarily supported by the agency, but do represent alternative views on subjects related to Antimicrobial pesticides. A list of some additional sources of antimicrobial information can be found under Other Antimicrobial Information Sources.

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