Freya Farm, a pesticide-free cannabis producer, and processor located in Conway, Wash., was recently forced to issue a recall after the chemical o-Phenylphenol, listed under CA Prop 65, was found on its products. Testing traced the antimicrobial compound, known to cause cancer, back to Freya’s FDA-compliant food-grade gloves during packaging.
According to a report published in the Cannabis Industry Journal titled The Unregulated Cannabis, contaminated single-use gloves were responsible for the recent recall of products. The reason this could happen with FDA-compliant, food-grade gloves need urgent attention. The production and manufacturing of food contact gloves are largely unsupervised, with limited and infrequent checks on gloves imported into the US. After initial approvals, non-sterile, FDA-compliant food-grade gloves are not subject to ongoing controls. This may lead to lower grade and cheap raw materials being used in sub-standard production facilities and processes. Freya Farm said:
“Nothing ruins your day like testing your product, confident it will be clean, only to find it contaminated with some crazy, toxic chemical. The gloves were the last thing we tested; we just never imagined something sold as food-safe could transfer such nastiness. The discovery was just the beginning… recalls are costly in more ways than one.”
Deliberate or Accidental Contamination
The quality and safety of disposable gloves are limited to Letters of Compliance and Guarantee on the glove’s general make and model, not necessarily the glove you are holding in your hand. There are few controls on the consistency of raw materials, manufacturing processes, and factory compliance for food contact and medical examination grade gloves. Therefore, the opportunity exists for deliberate or accidental contamination within the process of which the Preventive Controls Qualified Individual (PCQI) may not be aware.
A recall of this type can be expensive, as fines range up to $200,000. Since this incident, Freya Farm has implemented a responsible sourcing policy for gloves using supplier Eagle Protect to protect its products, people, and brand reputation.
Eagle Protect, a global supplier of PPE to the food and medical sectors, is currently implementing a unique proprietary third-party glove analysis to ensure a range of gloves is regularly checked for harmful contaminants, toxins, and pathogens. This Fingerprint Glove Analysis mitigates the risk of intentional or accidental physical, chemical, or microbiological glove contamination by inspecting five factors: the use of safe ingredients, cross-contamination potential, cleanliness, structural integrity, and dermal compatibility.
Cheap Raw Materials Lower Glove Durability
Harmful toxins and contaminants in gloves have been identified in many peer-reviewed scientific studies. This is now a real issue for companies producing consumer products, especially in organics and cannabis, whose products must be handled by gloves and test clean.
After initial approval, non-sterile FDA-compliant food-grade disposable gloves are not subject to ongoing controls to ensure the reliability and consistency of raw material ingredients or quality processes during manufacturing. Opportunity exists for glove manufacturers to use cheap raw materials that lower glove durability and introduce toxic compounds that can transfer to glove users and products.
The company affected by the glove contamination, Freya Farm, grows high-grade and unique strains of cannabis. They have since started purchasing gloves from the US branch of Eagle Protect, which implements a proprietary third-party glove analysis to ensure a range of Eagle gloves are consistently high-quality, and free from harmful contaminants, toxins, and pathogens. Eagle Protect CEO Steve Ardagh explained:
“Sourcing quality, third-party tested gloves, from a company our customers can trust, is assurance they are receiving the best gloves to handle their products. Sourcing from us mitigates food safety and brand reputational risks.”
Dioxin Is Classified As a Carcinogen
The manufacturing PVC process releases dioxins into the atmosphere, as does burning or disposing of them in landfills. Some researchers have shown exposure to dioxins causes reproductive, developmental, and other health problems. At least one dioxin is classified as a carcinogen.
Vinyl gloves can also contain phthalates, which have been shown to leach from the gloves into the human body and leach into and evaporate into food, particularly fatty food. Some phthalates have been found to affect human health adversely and are on California’s list of known carcinogens.
Besides, studies have proven vinyl gloves have an increased permeability to bacteria and viruses, and in some cases, begin leaking as soon as they are donned. New research also shows vinyl gloves are an ineffective barrier during food handling and have three times the cross-contamination potential of quality nitrile gloves.
Issues with Gloves
According to Eagle Protect, while vinyl gloves are less expensive than nitrile, the economics goes beyond per-unit cost. But many glove supply companies and procurement managers don’t see it as such, failing to factor in food safety aspects, human health implications, and environmental concerns.
- Latex gloves are made out of rubber and are biodegradable, but some people are allergic.
- Nitrile gloves are made out of synthetic rubber and ideal for when latex allergies are of concern. They are also more resistant to chemicals that can compromise gloves made of other materials.
- Vinyl gloves are a popular choice for the food industry and situations in which high durability and protection levels are less of a priority. They are the less expensive option.
The Centers for Disease Control has no direct guidelines regarding what kind of gloves should be used in handling food and has not studied vinyl versus other kinds of gloves, according to Brittany Behm, a public affairs specialist in CDC’s Division of Foodborne, Waterborne, and Environmental Diseases.
The agency does recommend handwashing and wearing gloves when making food. Based on studies, the FDA notes that workers are more likely to wear gloves in chain restaurants, suggesting that restaurant managers may partially determine use.
Use of PVC in Health Care
Out of concern for toxic chemicals in products, healthcare institutions around the world, including U.S.-based Kaiser Permanente, have opted for nitrile gloves rather than vinyl. Kaiser, the nation’s largest integrated health care delivery program and user of more than 50 million gloves a year, also has moved away from tubing made from PVC.