1. You describe the “food safety gap” as a hidden risk to the United States food industry — why?
FDA food compliance (Title 21 Part 177.2600 — Nitrile Gloves) is a one-off test with no expiry date measuring glove raw materials and their migration potential into food. It does not test cleanliness or microbial levels or require gloves to be intact or without holes. In contrast, the Good Manufacturing Process (GMP — FDA Title 21 Part 110.10) states that gloves used for food handling should be “intact, clean, and sanitary condition.” The food safety gap is the difference between the GMP and the limited FDA food compliance requirements.
2. What regarding gloves is covered in the FDA Food Code?
The FDA Food Code (2022) also mentions the necessity of using “sanitary gloves,” again in contrast to the FDA food compliance requirements. Glove shipments are rarely checked on arrival into the U.S. Food compliance test results are based on trust with factories in Southeast Asia. We know from our own testing that many gloves with FDA food compliance would fail chemical migration checks on arrival.
3. The food safety gap seems real. Is it a significant issue?
Collaborating with leading microbiologist Barry Michaels, Eagle has developed a proprietary glove quality verification program, Delta Zero™. A range of Eagle gloves are tested on arrival for toxicity levels, safe ingredients and bioburden to ensure their food safety and performance. For baseline calibration, over 2,800 gloves were tested from 26 brands of unopened medical and food compliant gloves, and 250 viable pathogens were found, including E. coli, Salmonella and Listeria. In addition, over 50% of the gloves had fecal indicators! To be truly food safe, food handling gloves require increased compliance testing than what is currently performed.
4. This is distressing! Is it a real food safety risk?
Simply put, ask yourself: Do you want to take the (food safety and legal) risk of potentially and knowingly introducing pathogens and toxic contaminants into your food system?
5. How do I mitigate glove risks?
Realize FDA food compliance does not mean gloves are clean, intact and free from bioburden. Buy from a glove supplier testing to ensure against potential toxic and microbial contamination. Disposable glove sourcing should be incorporated into your HACCP protocol to identify key characteristics and tests required to mitigate this potential hazard.
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