The FDA Food Safety Modernization Act (FSMA) was introduced in 2011, aiming to prevent food contamination and subsequent foodborne illnesses rather than just respond to it. One overlooked element within the FSMA is disposable gloves. Labeled as intermittent contact items, the risk of contamination from these products is not seen as great enough to warrant close observation.
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However, growing scientific evidence shows disposable gloves, in direct contact with food, can and do affect food safety, with around 15 percent of food service foodborne outbreaks implicating contaminated gloves as contributory factors in the outbreak.
What are Food Service Gloves?
Food service gloves are certified under FDA Title 21 CFR Part 177, which states that the components of the glove must comply with the FDA regulations and consist of “Substances generally recognized as safe for use in food or food packaging.”
However, the quality and safety of disposable gloves is limited to Letters of Compliance and Guarantee on the general make and model of the glove submitted (once) for testing, not necessarily the subsequent gloves produced. There are few controls required for glove manufacturing relating to the reliability of raw materials, manufacturing processes, and factory compliance after the certification has been awarded.
It is possible for a glove manufacturer to achieve FDA Title 21 CFR Part 177 certification for a glove, then alter manufacturing and hygiene practices, and use cheap raw materials to save costs. Cheap raw materials lower glove strength, flexibility, and durability—increasing glove failure rates, and may also introduce toxic compounds, including known endocrine disruptors and potassium cyanide to glove users and food products.
Fluctuations in raw material prices and the demand for lower costs from the end user puts manufacturers under pressure to sacrifice ingredient quality and substitute raw materials to meet these demands.
The opportunity also exists for deliberate or accidental contamination within the manufacturing process, which the FSMA is now addressing.
Are Food Service Gloves Food Safe?
The AQL of a disposable glove is the “Acceptable Quality Level” and refers to a quality standard for measuring pinhole defects. Glove manufacturers test a random sample of gloves from a batch during initial production. The lower the AQL, the less defects gloves have. An AQL of 1.5, for example, requires that gloves be manufactured with no more than 15 failures for every 1,000 gloves produced.
In comparison to medical or examination grade gloves, no formal government regulations or inspection program exists for food service gloves over and above the FDA Title 21 CFR Part 177 regulation. There is no AQL requirement for food service gloves, meaning there are no guidelines for maximum pinhole defects—no guidelines for the number of failures per box.
Glove Holes and Food Contamination
Moreover, the human skin is a rich environment for microbes consisting of around 1,000 species, and the skin surface can contain on average 2 million to 10 million microorganisms. Most are resident species, some with the potential to cause disease (Staphylococcus spp. or Streptococcus spp.), but transient pathogens are the driver of foodborne infection transmission.
Organisms can become resident colonizers on hands, and combined with a glove puncture, a “liquid bridge” of microbial contamination can flow to contact surfaces of food.
Studies have shown up to 18,000 staphylococci can pass through a single glove hole during a 20-minute period, even though the hands had been scrubbed for 10 minutes prior to gloving. With more than 250 different foodborne diseases associated with food or drink, there is ample opportunity for leaky gloves to share responsibility for transmission.
In-use glove studies show that 50-96 percent of glove punctures go undetected by wearers, with the potential to release tens of thousands of bacteria from internal glove surfaces to food.
Chemicals that Cause Cancer
Vinyl (PVC, polyvinyl chloride) gloves are the most commonly used glove in food handling and processing in the U.S. due to assumed price savings. Up to 50 percent of vinyl glove raw materials are made up of plasticizers which, to reduce costs, can contain inexpensive phthalates DINP (Diisononyl phthalate) and DEHP (Bis(2-ethylhexyl) phthalate), and BPA (Bisphenol A).