Regulation of Antimicrobial Pesticides by the US Environmental Protection Agency

Regulation of Antimicrobial Pesticides by the US Environmental Protection Agency

Stephen F. Tomasino

Tajah L. Blackburn

Jacqueline L. Hardy

In the United States (US), certain types of antimicrobial agents such as hospital disinfectants used to treat environmental surfaces contaminated with a public health-related pathogen, are pesticides (ie, a substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest), and thus are regulated by the US Environmental Protection Agency (EPA). This chapter provides background information about the general considerations associated with the registration of pesticides in the United States with an emphasis on the regulatory requirements for antimicrobial products bearing public health claims. The views expressed in this chapter are those of the authors and do not necessarily reflect the views or policies of the EPA.


The US Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) provides for federal regulation of the distribution, sale, and use of pesticides.1 All pesticides distributed or sold in the United States must be registered (ie, licensed) by EPA, unless exempt. The FIFRA’s implementing regulations are found in Title 40 of the Code of Federal Regulations (CFR), Parts 150 to 189.2 Regulations are codified annually in the US CFR. Title 40: Protection of Environment is the section of the CFR that deals with EPA’s mission of protecting human health and the environment. Part 152 sets forth procedures, requirements, and criteria concerning the registration of pesticide products under FIFRA §3 (registration of pesticides). The EPA also derives authority to regulate pesticide residues on food items (eg, antimicrobial products intended to be applied to food or material or article that contact food) from provisions in the Federal Food, Drug, and Cosmetic Act (FFDCA).3 The Food Quality Protection Act (FQPA)4 amended both FIFRA and FFDCA and broadened the scope of how EPA regulates pesticides. For example, FQPA requires the EPA to make a safety finding when setting maximum residue levels (tolerances) to consider the special susceptibility of children to pesticides, and to consider aggregate risk from exposure to a pesticide from multiple sources (food, water, residential, and other nonoccupational sources) when assessing tolerances. The FIFRA was further amended by the Pesticide Registration Improvement Act (PRIA) of 2003, which was reauthorized by the Pesticide Registration Improvement Extension Act of 2018.5 The PRIA establishes pesticide registration fees for some registration actions under which applicants are required to pay a fee and, in exchange, EPA is obligated to perform certain registration functions within defined timeframes.

The following are terms associated with EPA’s regulatory authority under FIFRA:

  • 40 CFR §152.5. Pests. An organism is declared to be a pest under circumstances that make it deleterious to man or the environment, if it is (1) any vertebrate animal other than man; (2) any invertebrate animal, including but not limited to, any insect, other arthropod, nematode, or mollusk such as a slug and snail, but excluding any internal parasite of living man or other living animals; (3) any plant growing where not wanted, including any moss, algae, liverwort, or other plant of any higher order, and any plant part such as a root; or (4) any fungus, bacterium, virus, prion, or other microorganism, except for those on or in living man or other living animals and those on or in processed food or processed animal feed, beverages, drugs (as defined in FFDCA 201(g)(1)), and cosmetics (as defined in FFDCA §201 (i)).

  • 40 CFR §152.3. Definitions. In general, the term pesticide means any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest. See 40 CFR §152.3 for exclusions.

  • 40 CFR §152.3. Definitions. A pesticide product means a pesticide in a form (including composition, packaging, and labeling) in which the pesticide is, or is intended to be, distributed or sold. The term includes any
    physical apparatus used to deliver or apply the pesticide if distributed or sold with the pesticide.

The EPA’s regulation “Data Requirements for Registration,” which was issued originally in 40 CFR Part 158, specifies the types of data and information generally required under FIFRA. On October 26, 2007, EPA promulgated final rules establishing updated basic data requirements for conventional, biochemical, and microbial pesticides. On May 8, 2013, EPA published a final rule amending 40 CFR Part 158, to add a subpart setting forth basic data requirements that support an application to register an antimicrobial pesticide product. This final rule, which is codified as 40 CFR Part 158 Subpart W—Antimicrobial Pesticide Data Requirements,6 contains the basic data requirements specifically applicable to antimicrobial pesticides (see the following discussion).

As a useful tool, EPA’s Pesticide Registration Manual7 is intended to provide guidance for companies and individuals who want to have their pesticide products registered by EPA. Chapter 4 of the manual (Additional Considerations for Antimicrobial Products) provides specific information concerning the registration of antimicrobial pesticides.


Pesticide registration is a scientific, legal, and administrative process through which the EPA examines the ingredients of the pesticide; the particular site or crop where it is to be used; the amount, frequency, and timing of its use; storage and disposal practices; and labeling, to ensure when a product is used according to the label, no unreasonable adverse effects on human health and the environment will occur. The EPA’s pesticide review and regulatory activities are conducted by the Office of Pesticide Programs (OPP) within the Office of Chemical Safety and Pollution Prevention (OCSPP).8 Work related to the registration and regulation of antimicrobial pesticides is handled by the OPP Antimicrobials Division. An application for a registration action, for example, to register a new pesticide active ingredient, new product for an existing pesticidal chemical, or adding a new use to an existing product, is submitted by a company for consideration by EPA. The company seeking to register the pesticide, the applicant, must provide data from studies that comply with EPA data requirements at 40 CFR Part 158 Subpart W. The Antimicrobial Pesticide Use Site Index9 is used in conjunction with the data tables in the subpart to determine the applicability of data requirements to certain antimicrobial use patterns. Good laboratory practice standards, as defined in 40 CFR Part 160, apply to studies submitted to support the registration of pesticides. The pesticide registration process includes many common requirements applicable to the various types of pesticides, but some requirements are specific to the type of pesticide, such as the need for product efficacy data for antimicrobial pesticides bearing claims against public health pests.

In evaluating a pesticide registration application for a new active ingredient and/or new use, the EPA assesses a wide variety of potential human health and environmental effects and routes of exposure associated with use of the product to ensure that, when the product is used according to the proposed labeled directions, no unreasonable adverse effects on human health or the environment will occur. Risk assessments are conducted to evaluate the potential for harm to humans, wildlife, fish, and plants, including endangered species and nontarget organisms; contamination of surface water or ground water from leaching, runoff, and spray drift; and potential human risks ranging from short-term toxicity to long-term effects such as cancer and reproductive system disorders. If EPA determines that no unreasonable adverse effects to human health or the environment will result from the sale, distribution, and use of a pesticide product, it may then grant the applicant a license or registration to legally sell and distribute the product in the United States. Once an EPA registration has been granted, then the registrants must also address and comply with any applicable requirements imposed by the states in which they wish to sell or distribute their product.

An applicant who does not wish to register and produce its own unique product may become a supplemental registrant for another company that has already registered a product. This supplemental registration allows the new registrant to market the product under its own company and brand name. If a registrant has a product previously registered with EPA and wishes to make a change to the registration such as change the formulation or labeling text (ie, add, delete, or change formulation components or label precautionary statements, or add or change uses), it must file an application to amend its registered product.


All registered products must bear an EPA-approved label on every package. Regulatory requirements for pesticide labels are found in the 40 CFR Part 156. A Label Review Manual10 issued by EPA provides guidance on pesticide labeling with the goal of improving the quality and consistency of pesticide labels. The EPA reviews pesticide product labels as part of the registration process and must approve all label language before a pesticide can be sold or distributed in the United States. The overall intent of the label is to provide clear directions for use and effective product performance while minimizing risks to human health and the environment. Pesticide product labels provide critical information about how to safely and legally handle, use, and dispose of pesticide products. The label is considered the law and must be followed. In addition,
following labeling instructions carefully and precisely is necessary to ensure safe and effective use. Pesticide labels are legally enforceable and all of them carry the statement: “It is a violation of Federal law to use this product in a manner inconsistent with its labeling.”


All EPA-registered pesticides bear an EPA registration number on the label. The EPA registration number consists of two groups of numbers separated by a hyphen, for example, EPA Registration Number 12345-12. The first group of numbers refers to the registrant’s company identification number and the second group of numbers represents the registrant’s product number. Distributors may also sell products with identical formulations and identical efficacy as the primary products. Distributor products frequently use different brand names but can be identified by their three-part EPA Registration Number. The first two parts of the EPA Registration Number match the registrant and their product, whereas the third set of numbers represent the distributor identification number. For example, EPA Registration Number 12345-12-2567 is a distributor product (identified by 2567) with an identical formulation and efficacy to the primary product with the EPA Registration Number 12345-12.


Per FIFRA section 2(mm), an antimicrobial pesticide is a pesticide that is intended to (1) disinfect, sanitize, reduce, or mitigate growth or development of microbiological organisms or (2) protect inanimate objects, industrial processes or systems, surfaces, water, or other chemical substances from contamination, fouling, or deterioration caused by bacteria, viruses, fungi, protozoa, algae, or slime. In general, antimicrobial pesticides used on inanimate surfaces are subject to FIFRA, whereas antimicrobial substances used in or on living animals or humans are regulated by FDA under FFDCA (eg, human or animal drugs, antiseptics). Furthermore, some antimicrobial products are subject to both FIFRA and FFDCA (ie, dual jurisdiction products) because they involve direct or indirect food uses or use on food contact surfaces. The focus here is on antimicrobial pesticides with claims against public health pathogens intended for use on inanimate environmental surfaces.

Antimicrobial pesticides regulated by EPA contain numerous active ingredients (eg, sodium hypochlorite, quaternary ammonium compounds, hydrogen peroxide) and are marketed in many types of formulations including sprays, towelettes, liquids, concentrated powders, and gases. Many of these products are registered to control microorganisms infectious to humans on inanimate surfaces, and thus are intended to protect against microorganisms harmful to public health. Per 40 CFR Part 158 Subpart W §158.2204 (a) and (b), antimicrobial pesticide products are considered as either public health or nonpublic health, depending on the specific claims made on each product’s labeling.

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May 9, 2021 | Posted by in MICROBIOLOGY | Comments Off on Regulation of Antimicrobial Pesticides by the US Environmental Protection Agency

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