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Food-contact surfaces and the EPA/FDA tug of war

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When is a pesticide a pesticide? And when is a pesticide NOT a pesticide? When does an antimicrobial additive in plastic products used in food-contact surfaces become a “pesticide chemical?” These are just a few issues that the EPA and the FDA have been trying to sort out for quite some time.

Fortunately for the plastics industry, the federal government tackled the issue and sought to clarify the antimicrobial oversight confusion that reared its ugly head with the Food Quality Protection Act of 1996 (FQPA) with the Antimicrobial Regulation Technical Corrections Act of 1998 (ARTCA). That regulation amended the definition of a “pesticide chemical” and “corrected the unintended transfer of regulatory authority from the FDA to the EPA, that resulted from the passage of FQPA, for certain food-contact antimicrobials,” according to the FDA. “Specifically, ARTCA reestablished the FDA’s traditional regulatory authority for certain antimicrobials that are used in or on food-contact articles.”

When you look at the huge number of products – particularly the ubiquitous food and beverage containers that pervade our lives – we can see why something that was intended to protect us from being exposed to microbes might have been misinterpreted as a “pesticide.”  The FDA currently regulates antimicrobial substances incorporated in, or applied to, food packaging materials regardless of whether the substance is intended to have an ongoing effect on any portion of the packaging.

The FDA does not regulate “antimicrobials that are incorporated in, or applied to, objects that have a semi-permanent or permanent food-contact surface, other than food packaging, to provide a sanitizing effect on such surface.”Regardless of the regulatory framework under which an antimicrobial additive may fall, there are uniform testing standards to benchmark performance. These include but are not limited to:

  • ISO 22196, Measurement of antibacterial activity on plastics and other non-porous surfaces
  • JIS Z 2801 (Japan), Antimicrobial products – Test for antimicrobial activity and efficacy
  • QB/T 2591 (China), Antimicrobial Plastics, Test for Antimicrobial Activity
  • ASTM E2149-10, 10 Standard Test Method for Determining the Antimicrobial Activity of Immobilized Antimicrobial Agents Under Dynamic Contact Conditions

Conclusion

Antimicrobial additives in plastics bring proven broad spectrum germ-fighting capabilities to thousands of common use items and public area plastic surfaces. Antimicrobial additives and masterbatches also serve to protect plastic items and surfaces from microbial degradation thus maintaining their performance and prolonging their service life. Given the pervasiveness of plastics in developed nations and the ability of manufacturers and compounders to incorporate antimicrobial properties across a variety of formulations, plastic products and components could play a key role in keeping pathogens at bay in both medical and non-medical settings for years to come.

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