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Antimicrobials are big business in the USA

EPA seal

It seems that consumers are more concerned than ever about bacterial infections, particularly those that are antibiotic resistant. Antimicrobial products are big business in the USA. According to the U.S. Environmental Protection Agency (EPA), approximately one billion dollars each year are spent on a variety of antimicrobial products. More than 5,000 antimicrobial products are currently registered with the EPA and sold in the marketplace, according to a recent report.Nearly 60 percent of antimicrobial products are registered to control infectious microorganisms in hospitals and other health care environments. However, because many of these microorganisms have migrated outside the hospital setting into the general population, more and more products are being developed to fight these infectious bacteria before they can harm people.Because antimicrobials are considered pesticides, regulation of antimicrobial plastic additives in the U.S. is generally the domain of EPA under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). If certain dental uses are claimed, or if the plastic or product containing the plastic is intended for use on or in humans or animals, it could be classified as a drug and regulated by the Food and Drug Administration (FDA).Though rare, there are some antimicrobial additives for which the proposed use makes them both a food additive and drug (e.g., a no-rinse hand sanitizer used by food handlers).

In this case, the product may have to comply with the requirements of FIFRA applicable to both food additives and drug products. According to EPA regulations, antimicrobial articles/products can belong to one of two categories: public health products and non-public health products. Public health products are intended to control microorganisms infectious to humans in any inanimate environment. For example, most grocery stores have disinfectant wipes available for shoppers so they can wipe down the handles of shopping carts and baskets to prevent the spread of bacteria. Non-public health products are used to control growth of algae, odor-causing bacteria, bacteria which cause spoilage, deterioration or fouling of materials and microorganisms infectious only to animals.

When it comes to additives in plastic products in public places – such as shopping cart or basket handles – there are also some regulations. Because antimicrobials can’t discern whether their purpose is to preserve an article or protect human health, the EPA provides a carve-out known as the Treated Articles Exemption (TAE).  Under the TAE, articles (products) that use broad spectrum antimicrobials as a bio-stabilizer or preservative can be exempt from EPA registration as long as no claims are made regarding the ability of the article to provide a human health benefit.To qualify for the exemption, treated articles must display appropriate clarifying statements. If an article claims to be effective in controlling specific microorganisms (e.g., E. coli, S. aureus, Salmonella) it must be registered as a pesticide because EPA considers this a public health claim that goes beyond the preservation of the treated article itself.

In these cases EPA requires chemical data supporting the claims. Upon review, EPA could still determine that the product is exempt from registration as a pesticide and limit the manufacturer to claiming only that the product contains a pesticidial preservative to protect the product itself.So, whether companies are protecting people or their products, there are various regulations that must be followed. If you are thinking about using an antimicrobial additive in the plastic products you manufacture, you need to engage a knowledgeable supplier that can help you understand what you must do in order to be in compliance with the EPA and FDA regulations, if any are applicable to your product. 

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