FST Soapbox

Glove Polymers: The Unregulated Food Safety Threat

By Steve Ardagh
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January 11, 2019


• Categories: Compliance, Food Manufacturing, Foodservice & Retail, FSMA, FST Soapbox

Various polymers are used in food contact applications that include food packaging and disposable gloves. More than 30 different types are used in packaging and up to six in disposables gloves. In terms of safeguards for the U.S. food supply as well as user safety, it is worth noting that 87% of the production of packaging polymers is based in the United States and subject to FDA regulation and monitoring. On the other hand, all (100%) of the 100 or more glove factories supplying the United States are based in Southeast Asia, according to a report by the British Medical Association and are not subjected to the same FDA monitoring or scrutiny.¹

Packaging production is carefully overseen by the FDA, is included in FSMA, and covered in the HACCP process. Toxicology of food packaging is carefully prescribed and subject to strict enforcement action from production to storage.

Glove factories, however, are generally self-regulated, with FDA compliance required for a rough outline of the ingredients of the gloves rather than the final product. Few controls are required for glove manufacturing relating to the reliability of raw materials, manufacturing processes and factory compliance. A clear opportunity exists for accidental contamination within the glove-making process. More significantly, because of the geographic and economic implications in workforce and workplace conditions, intentional contamination potential is greatly increased. Polymer gloves utilized in food processing and service have been implicated in 15–18% of foodborne illness outbreaks in the United States.²

There is a striking difference in the requirements for these two different types of food contact polymers. Food packaging is extensively regulated, gets tested within the context of completed food product and has production primarily in the United States under close supervision. Disposable gloves, on the other hand, rely on self certification, often with testing results only on glove constituents, and little or no oversight of factory process and conditions. It seems as though this is a glaringly obvious but little accounted for risk to the U.S. food sector.

As a result, based on the root cause analysis of food cross contamination, a selection of tests and certifications, some of which are unique to the glove industry, are being implemented by one particular glove supplier. These tests ensure that their gloves coming into the United States are made in clean, well-run factories, free of any type of contamination and are consistent in material makeup to original food safe specifications. This glove fingerprint testing program consists of a number of proprietary risk reduction steps and targeted third-party testing methods, includes gas chromatography combined with mass spectroscopy (GC/MS, surface free energy determination, in vitro cytotoxicity analysis, and microbial viability-linked metagenomic analysis.

With a great deal of faith placed on a glove supplier’s ability to deliver disposable gloves sight unseen, I believe these tests are essential to further reduce the food safety risks associated with them. Objective…Zero surprises!

References

1. Bhutta, M. and Santhakumar, A. (March 2016). In Good Hands. Tackling labor rights concerns in the manufacture of medical gloves. British Medical Association. Retrieved from https://www.bma.org.uk/collective-voice/influence/international/global-justice/fair-medical-trade/medical-gloves-report.
2. Michaels, B. (2018). Determination of the % of Foodborne Illness Outbreaks Attributed to Glove-Related Cross-Contamination. Unpublished report

The author would like to acknowledge Barry Michaels, an international scientific consultant on food safety, infectious disease transmission and glove use, who has assisted in the fingerprint testing program discussed in this column.