Antimicrobial regulation – USA
The U.S. Environmental Protection Agency (EPA) regulates antimicrobial pesticides separately from conventional pesticides and biopesticides. Antimicrobial pesticides are substances or mixtures of substances that prevent, destroy, repel or mitigate microorganisms on inanimate objects and surfaces.
Depending on the formulation of the product, uses and label claims, the product may be exempt from federal and state regulation or may be regulated by either EPA or the Food and Drug Administration (FDA) or by both agencies.
Examples of antimicrobial products include sanitizers, disinfectants, algaecides, preservatives, fungicides, and germicides. Antimicrobial pesticides may be used in the manufacture of treated articles. EPA regulates non-public health and public health pesticides. Non-public health pesticides control the growth of microorganisms such as algae and odor-causing bacteria, bacteria that cause spoilage, deterioration or fouling of materials and microorganisms that are only infectious to animals. Examples of non-public health uses include antimicrobials used in cooling towers, paints, plastics, and treatment for textiles and paper products.
Antimicrobials that are intended to control microorganisms infectious to humans in any inanimate environment are considered public health antimicrobials. These products include sterilizers, disinfectants and sanitizers. Examples of public health uses include antimicrobials used in hospitals, institutions, schools, industrial settings such as food processing facilities and homes.
Antimicrobial pesticides require registration by EPA and in every state in which they are distributed. These products are evaluated based on their chemistry, toxicology, product performance, and use site using guidelines established under FIFRA (Federal Insecticide, Fungicide, and Rodenticide Act).
TSG can help
- Prepare and submit federal and state registrations
- Develop product registration strategy
- Obtain Company Number and Establishment Numbers
- Prepare and submit pesticide inert petitions
- Place and monitor studies with contract research labs
- Prepare data waiver rationales
- Conduct compliance audits including recordkeeping requirements
- Develop and review labels
- Review product claims for compliance
- Address annual reporting, registration review and renewals
TSG provides companies with high-quality regulatory and scientific consulting services. We aim to understand our clients' goals and objectives, learn the scientific and technical aspects of projects and anticipate compliance challenges to plan a strategic path forward. TSG's team of experts is deadline-focused, responsive and committed to professionalism. We have the utmost respect for the confidentiality of our work, strong project management skills, and take great measure to cultivate long-term partnerships with clients.
TSG has a team of scientists and regulatory consultants who manage all aspects of product registration, lifecycle management and strategic planning with our customers. Key professionals working with antimicrobials, sanitizers and disinfectants include Juli Mann, Julie Ownbey, Hal Stowe and Abigail Wacek, and in our state team Kelly Rahn, April Kitchen and Ananda Thomason.
Frequently asked questions
No, under FIFRA cleaners and deodorizers are exempt from registration. However, there is a tremendous amount of complexity associated with the intended use of the product and whether EPA would consider a specific claim to be pesticidal, thus triggering the requirement for registration. TSG can assist in helping to navigate the complexity of these claims and provide guidance on claims to avoid the need for EPA registration.
Yes! EPA considers the term “germ” as a public health efficacy claim. Any product claiming to kill or control germs on environmental surfaces must first register the product with the EPA and in the states. TSG’s consultants can assist your company in identifying the data required to support a germs claim, in developing label language to support the claim, and in submitting an application to support the addition of this claim to a pesticide product label.
The EPA registers antimicrobial products based on formulation, use site, and claim. Product applications must address information specific to the active ingredient as well as product specific product chemistry, acute toxicity, and efficacy data. The application must also include a robust product label. TSG’s scientific and regulatory consultants have extensive expertise in supporting clients in developing product registration strategies, as well as preparing and submitting federal and state registrations. We can work with you to identify the data applicable to your registration, assist in preparing an EPA-compliant product label, develop testing strategies including protocol development as well as complete the necessary administrative paperwork to support your application. TSG can submit product applications on your behalf and engage with the EPA throughout the registration process and negotiate novel claims, thereby supporting your application from beginning to end.
The FDA has authority over hand wash products in the U.S. under the Federal Food, Drug, and Cosmetic Act. This Act also addresses the use and safety of medical device products which are used to clean, disinfect, sterilize, or otherwise treat medical devices. TSG consultants assist companies in navigating the complex regulations associated with the sale of hand washes and sanitizers in the U.S.
Products which are EPA-registered broad spectrum or hospital disinfectants with applicable virucidal claims under the EPA’s emerging viral pathogen program may make claims against SARS-CoV-2, a coronavirus that causes COVID-19 as long as the products have the emerging pathogen required language on their label. EPA maintains a list Disinfectants for Use Against SARS-CoV-2. There may be additional disinfectants which meet the criteria but which are not yet on the list. EPA is updating the list regularly.
No. In addition to efficacy as a broad-spectrum or hospital disinfectant and at least one large or one small non-enveloped virus, in order to make a claim against an emerging viral pathogen such as SARS-CoV-2 you must have first submitted supporting documentation to EPA under the emerging viral pathogen. TSG can work with you to confirm if your existing data will support the claim and assist you in preparing a submission package to EPA. EPA has initiated a process to expedite review of some emerging pathogen claims.
No. Treated article claims are limited to preservation of the article itself. Additionally, the emerging pathogen guidance is only applicable to disinfectants applied to hard, non-porous surfaces. The EPA has not registered any textiles which can make claims against the coronavirus.
Yes, if the only change being made to the label is the addition of the emerging pathogen language and there is no data to review. To allow for EPA to quickly expedite the submission, it is recommended to submit via EPA’s online CDX portal. Your TSG consultant can assist you in preparing a submission so your product may be added to List N: EPA’s Registered Antimicrobial Products for Use Against Novel Coronavirus SARS-CoV-2, the Cause of COVID-19.