Treated articles compliance – USA
Treated articles refer to products that are treated with pesticides in order to protect the item itself. In the U.S. they are regulated by the Environmental Protection Agency (EPA). While treated articles are exempt from registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), these products are highly regulated.
Paint treated with a pesticide to protect the paint coating, shower curtains treated to resist deterioration by mildew, a master batch used to produce children’s toys, and socks treated with an antibacterial to limit odor, are all examples of treated articles and may be sold as such in the USA.
Treated articles and substances are exempt from registration under the Code of Federal Regulations (40 CFR 152.25), provided that the pesticide used in the product is registered for such use. For example, a company that wants to use a materials preservative to treat clothing, must use only an EPA registered materials preservative product that is approved for use in textiles, and not one approved in only plastics or coatings. It is important to note that in order to qualify for the treated article exemption, the specific materials preservative product must be approved by EPA and not simply a product with the same active ingredient.
There are strict rules surrounding claims that manufacturers can make about treated articles. FIFRA does not allow companies to make public health claims that go beyond the preservation of the treated article itself. Claims for treated articles or substances are limited to clarifying statements like: “Antimicrobial properties are built in to inhibit the growth of bacteria that may spoil or foul this product. The antimicrobial properties do not protect users or others against bacteria, viruses, germs, or other disease organisms. Always clean and wash this product thoroughly before and after each use.”
TSG can help
- Understand the limits in the claims that a treated article can make
- Register a materials preservative for use in the manufacture of a treated article
- Review marketing material to determine if the claims fall within the exemption
- Develop claim guidance for manufacturers to provide to their customers
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's team of scientists and regulatory consultants manage all aspects of product compliance with our customers. Our Washington, DC-based Federal Affairs team is led by Abigail Wacek.
Frequently asked questions
No. The term “germ” is a public health claim. EPA does not allow public health pesticidal claims on treated articles. Claims for treated articles would be limited to a statement like “Antimicrobial properties are built in to inhibit the growth of bacteria that may deteriorate product. The antimicrobial properties do not protect users or others against food-borne bacteria. Always clean and wash this product thoroughly before and after each use.” TSG's experts routinely advise clients on the claims treated articles can make, as well as develop claim guidance for manufacturers to provide to their customers.
FIFRA requires the registration of any substance intended to prevent, destroy, repel, or mitigate pests. However, certain exemptions are made under the Code of Federal Regulations allowing the non-public-health use of a pesticide that is intended to protect only the treated article or substance itself, for example to preserve a paint coating or a fabric. Products that qualify for this exemption must display appropriate clarifying statements. TSG’s experts can advise if your product qualifies for a treated article exemption as well as review the required clarifying statements.
In order to qualify for the exemption, a product must have an EPA pesticide registration to be used in the manufacture of a treated article. These products, often called materials preservatives, may be registered for incorporation into or for the treatment of plastics, films, coatings, textiles, and other finished goods. TSG can advise on whether a product is registered with EPA and whether the registration is appropriate for use in the manufacture of specific types of treated articles.
Pesticide products for sale in the United States require registration with the EPA as well as individual states. The process to register a pesticide requires the submission of an application that addresses product-specific chemistry, toxicity and efficacy, as well as information on the active ingredient. The applicant must submit a label and there is an EPA application fee and decision review time. TSG’s experts can provide a registration strategy assessment tailored to your specific formulation, desired use site and claims. Follow the link to learn more about how we can help with pesticide compliance.