From time to time, our customers seek to understand more about how the EPA regulates products like SafeHandles. In explaining the EPA’s regulatory role, I often refer to our products use of our active agent as one that is regulated under the EPA’s Treated Article exemption. So what exactly does this mean? One of the labs we have worked with closely in the past, explains this wonderfully!
A “Treated article” is industry-speak for a solid or semi-solid object or product rendered antimicrobial by incorporation of an active ingredient into or onto the object itself.
For the purposes of this article, “treated articles” do not include medical devices or surfaces with claims to control microorganisms of public health concern.
Here is how EPA puts it: “The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) require the registration of any substance intended to prevent, destroy, repel, or mitigate pests. However, the Code of Federal Regulations prescribes the conditions under which an exemption from registration is allowed for treated articles or substances designed to protect products from microbial attack.”
Basically, “treated articles” are not regulated in the U.S. as are disinfectants (efficacy and safety data are not reviewed by the EPA). Such antimicrobial products are not allowed to make public health-related claims, including unqualified claims that they are “antimicrobial.”
The confusion people experience when learning about and discussing antimicrobial consumer products is totally understandable! Part of the problem is that the term “antimicrobial” is very broad. Basically, anything that has a negative impact on microorganisms can be called “antimicrobial.” Among antimicrobial consumer products, there is a range of activity, illustrated in the figure that appears below:
After considering the figure above, one might feel compelled to ask the question, “So products like antimicrobial pens, antimicrobial fabrics, antimicrobial countertops, and antimicrobial surgical scrubs…. What kind of antimicrobial activity do they possess?”
It’s an excellent question. The degree of antimicrobial activity in an “antimicrobial” consumer product varies by manufacturer and product but in general, most treated articles demonstrate the kind of antimicrobial activity you’d find on the left half of the figure above. That is, companies have usually carried out tests on the antimicrobial products that demonstrate either growth-inhibiting or mildly “cidal” (germ-killing) properties.
Some test methods commonly used to determine the antimicrobial activity of solid treated articles are JIS Z 2801 and ASTM E2149. These test methods aren’t as realistic as they could be, and it is possible for a product to “pass” these tests without producing an appreciable antimicrobial effect in “real-life” settings.
Many of the companies that make “treated articles” go the extra mile for their antimicrobial products. That is, whether they make the label claims or not, they develop products that have a public health impact and test them against relevant microorganisms using relevant test systems (many of which are designed on a custom basis).
John Bergenske, Technical Director