Safeguarding the US Food Supply
The CDC estimates 48 million people get sick, 128,000 people are hospitalized, and 3,000 people die each year from foodborne diseases in the US alone.
The Food Safety Modernization Act (FSMA) aims to ensure the US food supply is safe by shifting the focus from responding to contamination to preventing it. Food contact surfaces are divided into four zones depending on their level of risk of contamination, Zone 1 being the highest risk for product contamination. In a recent guidance, the FDA confirmed gloves as a Zone 1 Food Contact Surface.
It is estimated 328 million disposable gloves are used daily in the U.S. Most are manufactured in factories in Malaysia, Thailand and throughout Asia where labor conditions can be poor, and bioterrorism risks extensive.
FDA (21 CFR 177) compliance for food handling is a one-off test with no expiry date, focused on chemical migration tests only; “Food Compliant” gloves are not tested for bioburden, cleanliness, or performance, making it easy for manufacturers to change ingredients and manufacturing standards. Using dirty water sources and poor QA procedure during production in an effort to cut costs can lead to chemical and microbial contamination. Opportunity exists for deliberate or accidental contamination within the process, of which the Preventive Controls Qualified Individual (PCQI) may not be aware.
Opportunity exists for deliberate or accidental contamination within the process.
Risks During Glove Manufacturing
While poor manufacturing practices have resulted in reported instances of physical, chemical, and microbiological contamination, the capacity for bioterrorism involving gloves has not been recognized. A great deal of faith is placed in suppliers’ ability to deliver disposable gloves sight unseen. With an end user’s focus often on price, the “ingredients” of a glove’s raw material can be unknowingly changed, lacking qualification, or testing and produced under unsanitary conditions.
Commonly used glove elastomers can support a wide assortment of microbial species identified as capable of food bioterrorism. It has been clearly demonstrated in experiments that bacteria persist on gloves and transfer to contact surfaces.
The most comprehensive feature in the new food safety regulations under FSMA is the requirement for a detailed hazard analysis of every step in the manufacturing process of human and animal food.
It is for this reason that performing hazard analysis of the glove manufacturing process and supply chain is essential. Studies have revealed critical control points important in glove production and highly significant in preventing intentional contamination.
Risks of Bioterrorism Connected to Food And Glove Supply
Disposable glove safety, efficacy and food security as related to the supply chain is a particularly complex matter. Without glove supply chain transparency, the insertion of a bioterrorism agent is a possibility. While glove punctures, rips and tears are unfortunately tolerated during food handling, with only the occasional loss of life, illness, complain or recall, glove integrity takes on greater importance in the context of bioterrorism.
Accidental or Intentional Glove Manufacturing Risks
Areas of weakness in the food chain include processes that already have risk of accidental contamination—food packaging and glove manufacturing. Weaknesses within either packaging or the glove production process can be exploited and weaponization is clearly possible.
Expendable individuals may knowingly or innocently spread contamination during glove manufacturing work duties. High turnover, low wages, poor working conditions, and difficulty in imposing security in glove manufacturing factories can leave food products at risk. The same is true of food packaging, the difference being that per head count each glove worker can be responsible for producing over 2.5 million gloves each year.
Just like food packaging, leak prevention is critical for gloves - a sweaty, punctured, and leaking glove is an ideal mechanism for distributing chemical or biological contamination to foodstuffs. Scenarios to combat physical, chemical, and microbiological contamination are normal in food safety programs, but potentially deliberate hazards are factors not normally considered.
How to Reduce The Risks Of Glove Contamination
To effectively combat food contamination, risk managers are putting preventive control systems in place.
It is important to reduce the potential for all adverse events related to normal glove use from chance contamination to the extremes discussed here. This can only be achieved by using qualified gloves with significantly higher margins of safety - including ethical manufacturing certifications and factory audits, incorporating HACCP and quality control systems, and independent testing for raw material consistency and against microbial and chemical contamination. Consistency and attention to detail by a glove supplier is essential for food safe gloves, where quality and performance must come without unwanted chemical or microbiological issues.
Numerous studies have shown vinyl gloves have an increased permeability to bacteria and virus, increasing the risk of cross contamination for both the glove users and the food they are handling. To reduce costs, suppliers often allow inexpensive phthalates and BPA to be added during manufacturing. Adverse health effects of exposure to BPA and phthalates in US food and occupational settings is estimated to result in $175 Billion in healthcare costs. Read further information on vinyl gloves risks.
Because of their chemical resistant properties, high strength and thin wall construction, qualified nitrile gloves can be used as an adjunct to personal protection equipment where applicable, to prevent exposure.
Next Generation Safety Assurance Certification
Most cosmetic and drug manufacturers check every lot of raw materials against an internally developed standard.
This level of chemical and microbiological safety assurance can be achieved with disposable gloves by select and proprietary analysis of proven effectiveness. Eagle Protects proprietary independent glove verification program ensures against the risk of harmful chemical or microbial contamination or change in raw materials during manufacturin. This provides manufacturers and food service customers consistently—safe gloves with an improved accidental or intentional contamination profile.
There are identified potential risks associated with disposable gloves and food chain contamination. To improve shelf-life and reduction in the risks of food borne illnesses, glove distributors should provide documented supply chain transparency and manufacturing hazard mitigation. This should include all issues related to glove factory operation, hygienic and ethical labor practices, demonstrated through a multi-leveled certification process.
The disposable glove industry and food producers reliant on critical glove supplies have been able to run for a long period without any accountability to the food chain. Fortunately, times have changed and a greater level of safety assurance is mandated by the government, the food industry and customers.
