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If Microchem Laboratory had a bacterial colony for each time one of our scientists explained the EPA treated article exemption to a customer, we'd have a loaded petri dish!
Microbiology humor aside, our customers know we are glad to help them navigate the complicated world of antimicrobial regulations. If you have questions about your company's antimicrobial surfaces, just contact the laboratory or give us a call and we'll help you, too.
In that spirit, let's dive into a discussion of the EPA Treated Article Exemption.
On March 6, 2000, EPA issued Pesticide Registration Notice #2000-1, entitled "Applicability of the Treated Articles Exemption to Antimicrobial Pesticides." This notice served to clarify the exemption from FIFRA regulation for certain antimicrobial surfaces and objects laid out by FIFRA in 40 CFR 152.25(a).
To paraphrase, the EPA treated articles exemption says this: "If an antimicrobial treated object or surface is to be exempt from regulation by FIFRA (meaning manufacturers don't have to get EPA's approval prior to selling it), then the incorporated antimicrobial chemical must be registered with EPA and the product claims must describe protection of the product, not protection of the person using it."
If your antimicrobial object is intended to protect public health, then it must be registered with EPA through their pesticide registration process. As one part of that process, GLP efficacy data must be generated. To explore this option, call us at (512) 310-8378.
Note: odor control claims are not considered health claims by EPA.
To help people better understand the treated article exemption, we at Microchem have taken the liberty of making an educational "claim game." To play the game, simply mouse over the picture you think best answers the question. Let's play!
Which of the following objects is most likely to be an EPA-Regulated "Treated Article?"
One of the first things an antimicobial manufacturer must learn is the regulatory classification of their object, device, or liquid because all antimicrobials are not regulated alike. In fact, the regulations that pertain to disinfectants totally different from those that pertain to medical sterilants, which are different from those that pertain to antimicrobial medical devices.
In this article, we are discussing treated articles and the EPA treated article exemption, so the next question has to do with the verbiage of a treated article claim operating under the treated article exemption. As you recall, the treated article exemption basically says that an antimicrobial manufacturer does not need to interface with EPA, provided they use a registered active ingredient and the claims center on product protection, not people protection.
Which of the following claims is OK for an EPA Treated Article?
As the game illustrates, the only permissible claim of the three above is "Treated with an antimicrobial to protect the phone." The "Kills MRSA" claim is pretty obviously a claim related to people-protection. However, the blanket "antimicrobial" claim often trips up manufacturers. EPA sees the un-qualified term "antimicrobial" as a health-related claim, so it cannot be used by itself for products wishing to operate under the treated article exemption.
There are manufacturers who have been fined by EPA for claiming an object was antimicrobial without making it clear to consumers that the effect applies to the product and does not confer protection to the user. For example, Logitech and the company that makes Crocs sandals were both fined more than $200,000 in recent years.
There is still the issue of laboratory testing. What is required? In brief, manufacturers have a great deal of leeway with regard to how to go about substantiating claims that an object operating under the TAE is antimicrobial, but must do substantial testing to protect themselves from lawsuits from competitors and enforcement by the Federal Trade Commission.
The term antimicrobial is broad, as explained on this antimicrobial surfaces page. As a result, there are a host of test methods to choose from, some of which are very sensitive to antimicrobial activity, such as the JIS Z 2801 or ASTM E2149 methods. Microchem Laboratory has mastered both of those techniques and can provide a quick and easy price quote if your firm is at that stage of the R&D process.
Whichever method you choose, it is imperative to choose a laboratory well versed in the technique. It should employ experienced microbiologists trained in antimicrobial testing. As mentioned previously, the methods can be very sensitive and so by nature can be inherently variable.
The last thing a company needs is to have an antimicrobial surface submitted to a laboratory and have antimicrobial activity go undetected due to lab error. Conversely, it is important for a manufacturer to know if activity is not as great as warranted by the antimicrobial active ingredient supplier before the product hits the market.
By reading this article, you have learned the basics of the Treated Article Exemption by EPA. You now know to make sure that your active ingredient which will be incorporated into the product is registered with EPA appropriately and you have a good handle on what kind of claims will be allowed on the product label, including "collateral marketing materials" like webpages. Lastly, you know that it is crucial to work with a knowledgeable, reputable, independent laboratory with a specialty in antimicrobial testing to substantiate your claims.
Microchem Laboratory encourages you to contact the laboratory if you have any questions about the treated article exemption, or if you would like us to email you the PR Notice 2000-1.pdf file.
Lastly, please note that EPA regulations can be somewhat nuanced and interpretation of the rules may change depending on EPA staff perspective. Thus, Microchem Laboratory encourages companies to verify regulatory compliance with expert consultants or directly with EPA prior to sale.