FIFRA Compliance: Five Tips for Antimicrobial Apparel Manufacturers and Distributors
Over the course of the COVID-19 pandemic, interest in antimicrobial apparel has sharply increased. Often, textile fibers or fabrics are treated or impregnated with an antimicrobial substance and then made available to downstream apparel manufacturers for incorporation into finished clothing articles. Yet because bacteria, viruses, and other microbes are considered “pests” under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), a treated article that makes or implies claims to act against or provide protection from microorganisms may be subject to registration by the U.S. Environmental Protection Agency (EPA) as a “pesticide” product.
A wide range of products making antimicrobial claims have received increased FIFRA enforcement scrutiny from EPA over the last two years. Apparel manufacturers and distributors alike should take steps to ensure their products comply with FIFRA: pesticide manufacturers are responsible for registering their products under FIFRA, but anyone in a supply chain that sells or distributes an unregistered pesticide may be independently liable for violating the law. This may include apparel brands, wholesalers, small or large retailers, website marketplace operators, importers, and other partners throughout the distribution chain. This article offers five brief tips that producers and distributors of clothing articles with antimicrobial claims should always keep top of mind, and especially in the midst of the ongoing pandemic.
Know the Law and How It Applies to Your Activity.
FIFRA prohibits the distribution or sale of any pesticide that is not registered with EPA. This may include many textiles, fabrics, and even finished clothing articles that incorporate pesticidal substances. Examples of such FIFRA-regulated articles are certain fabrics impregnated with mosquito repellents, textile fibers that incorporate antifungal agents, or textiles with “antimicrobial,” “self-sanitizing,” or “self-disinfecting” claims.
Generally, EPA requires approval (or “registration”) in advance of any sale or distribution of these products. EPA must also approve all labeling claims and closely regulates product production, packaging, import, and advertising. In the case of treated textiles that are subsequently fabricated into garments and other finished articles by downstream manufacturers, EPA frequently requires the original textile manufacturer to register its own product, while requiring any finished articles incorporating those textiles to bear hangtags or other labels with EPA-specified text.
Pay Close Attention to Product Claims.
In many cases, the mere mention of a textile’s antimicrobial or antiviral properties may be sufficient to trigger EPA jurisdiction under FIFRA. Distributors of finished clothing articles with such claims should ensure that antimicrobial textiles and fabrics used in their products are appropriately registered by EPA, and that FIFRA labeling accompanies their own finished articles if required by EPA.
In addition, marketing and advertising claims must not differ substantially from claims approved by EPA as part of a treated textile’s registration. For example, if EPA has only approved an antibacterial claim for a textile, it would be a violation of FIFRA to market subsequently fabricated apparel with antiviral claims. It is also a violation of FIFRA to use a registered article in any manner inconsistent with its label. For example, if an antimicrobial textile has been registered by EPA for use only in socks and footwear, that textile should not be incorporated into any other garments.
Don’t Forget the States.
In addition to registration by EPA under FIFRA, a treated textile must be separately registered in every state where it may be sold or distributed. Individual state registration policies may vary. California, for example, also requires each company who sells products made from pesticide-impregnated textiles into or within the state to obtain at least one registration for each category of product sold (e.g., “apparel” or “non-apparel”).
Be Careful With Exemptions.
EPA provides a narrow exemption from FIFRA regulation for certain treated articles that incorporate registered pesticides intended solely to protect the articles themselves from odor, deterioration, or degradation. Clothing articles may be eligible for this “treated article exemption” if an appropriately registered antimicrobial preservative is used and claims for the finished article are very carefully qualified.
Keep in mind that a treated article’s exempt status may be forfeited if it is distributed with claims that are too broad or otherwise imply protection against viruses or other public health pests. For example, a treated fabric that narrowly claims to resist bacterial odors may be eligible for the treated article exemption if it otherwise meets EPA’s criteria; the same product, if distributed with claims to provide unqualified antimicrobial protection, will very likely not.
Keep In Mind FDA’s Separate Requirements.
The U.S. Food and Drug Administration (FDA) may separately regulate apparel items like facemasks or surgical gowns intended for use in healthcare or medical settings. Although EPA excludes certain FDA-regulated products (like liquid chemical sterilants) from regulation under FIFRA, EPA does not provide a blanket FIFRA exclusion for all FDA-regulated articles. This means that dual EPA/FDA jurisdiction is very possible for many products, and distributors should not assume that FDA’s regulation of a particular article will be sufficient to absolve them from EPA compliance obligations under FIFRA.