Problem/Situation
Just because a High Density Polyurethane (HDPE) food service glove has FDA food contact certification labeling does not mean the glove actually works in preventing cross contamination. OSHA doesn’t specify glove requirements other than they be fit for use. Thus, the burden of risk and liability for glove selection is shifted to glove purchaser for knowing which glove to purchase.
The FDA only initially monitors food glove composition to prevent harmful chemical consumption by consumers. The FDA does not monitor food glove integrity such as pinholes, leaks, and failure rates for the effective prevention of cross contamination as is the case for medical examination gloves.
Improper disposable glove selection for a glove use management system in retail food service is in part due to the misleading “FDA Title 21 CFR part 177 approved for food contact” certification on glove package labeling. This labeling implies that the FDA approves this glove for food service in all capacities giving a false sense of security but in actuality may result in the selection of gloves “not fit for use” causing increased risk of foodborne illness due to cross-contamination associated glove integrity breach failure.
Employers are responsible for selecting of food service gloves that are “fit for use” and intended to reduce cross contamination from food borne illness in customers and employees.
Food borne illness risks include customer complaints and lawsuits, employee illness/workman’s comp claims, traceability investigations, regulatory fines, closures, negative publicity.
Prevalence:
- 328 million US population 2019
- 48 million food borne illnesses /year
- 128,000 hospitalizations/year
- 3,000 deaths/year
- 1 in six customers will contract food borne illness
- 1 in 2,562 customers will be hospitalized
- 1 in 109,000 customers will die
- In 16-20% of food borne illness outbreaks, gloves have been contributory to cross contamination.
- Glove choice based upon sustained integrity and durability can result in at least 3 times less risk or higher of glove breach risk is not ascertained at time of glove purchase
- Chemical composition consumption risk must be ascertained periodically to ensure unregulated ongoing quality control.
- Gloves, however, have created a false sense of security with handlers that bacteria can't get into the food and thus, they only wash their hands 27% of the time, according to the CDC.
These numbers only reflect reported cases of food-borne illness; many go unreported. One must ultimately evaluate food glove based upon chemical composition toxicity, failure rates, pinholes, manufacturing quality control and costs to provide adequate protection.
A cheap food glove can contain toxic chemicals, even though stated as FDA approved for food contact. A glove with a higher leak rate will substantially increase cross contamination risk and increase liability associated with food borne illness - both traceable and unknown.
It is estimated that around 90% of all disposable glove perforations during use go unnoticed or undetected. A glove with a lab tested leak rate of 4 gloves per 100 will result in an approximate 3-fold increase in risk over a glove that meets the medical examination glove standard of 1.5 leaks/100 gloves.
2017 FOOD CODE US FDA
https://www.fda.gov/media/110822/download
Preface i
- FOODBORNE ILLNESS ESTIMATES, RISK FACTORS, AND INTERVENTIONS Foodborne illness in the United States is a major cause of personal distress, preventable illness and death, and avoidable economic burden. It is estimated that foodborne diseases cause approximately 48 million illnesses, 128,000 hospitalizations, and 3,000 deaths in the United States each year. The occurrence of approximately 1,000 reported disease outbreaks (local, regional, and national) each year highlights the challenges of preventing these infections. Most foodborne illnesses occur in persons who are not part of recognized outbreaks. For many victims, foodborne illness results only in discomfort or lost time from the job. For some, especially preschool age children, older adults in health care facilities, and those with impaired immune systems, foodborne illness is more serious and may be life threatening. The annual cost of foodborne illness in terms of pain and suffering, reduced productivity, and medical costs are estimated to be $10 - $83 billion.
Are food gloves safe?
The “FDA Title 21 CFR part 177 approved for food contact” regulates the chemical composition of the gloves such that the glove components are safe and there is low risk of harmful chemical exposure. 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, meaning there are no guidelines for maximum pinhole defects-no guidelines for the number of failures per box. No guidelines for glove breach integrity or toxicity.
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, 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.
The AQL of a disposable glove is the “Acceptable Quality Level” and refers to a quality standard for measuring pinhole defects. In this test, 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 of a medical glove, for example, requires that gloves be manufactured with no more than 15 failures for every 1,000 gloves produced.
Foodborne pathogens with low infective doses may be present on hands in high numbers and can be easily transferred to foods, food contact, and nonfood contact surfaces, necessitating barriers to transmission.
According to FDA, when hands are contaminated or soiled, effective hand hygiene practices may not be sufficient to prevent the transmission of transient pathogens from the hands to ready-to-eat (RTE) foods. The 2017 FDA Food Code discourages bare-hand contact with RTE food and recommends the use of suitable utensils, deli tissues, single-use gloves, or dispensing equipment when handling these food items. The majority of individual state food codes have adopted and enforce this rule. The obvious objective in utilizing gloves in foodservice is to minimize physical, chemical, and microbiological contamination of food. Gloves can unfortunately offer a false sense of security both on the part of food workers and food safety managers when employees are not trained, and glove use is not supervised properly.
In a study of 18 independent delicatessen operations, widespread microbial contamination (Escherichia coli, Staphylococcus aureus) was found on turkey, cream cheese, lettuce, and food contact surfaces. A subsequent review of health inspection observations revealed that there was 1) inadequate hand hygiene, 2) no gloves used, 3) improper single-glove use, and 4) inadequate glove changes in 39 percent, 33 percent, 28 percent, and 67 percent of these delis inspected. Other glove-use behaviors have been identified that cause cross-contamination when gloves are worn for long periods of food prep and not changed when punctured or contaminated. Additionally, pathogens can be found to adhere better to the surface of gloves worn by food employees when gloves fit poorly or if gloves are not changed regularly.
The use of gloves does not reduce the need to ensure proper handwashing before and after glove use. Because hands, like other surfaces, can become coated with oils, grease, and fats, for example, they should be both cleaned and sanitized, just as a food contact surface is cleaned and sanitized. This is especially important during use of food service gloves. The effective use of gloves depends on selection of the right glove type and maintenance of glove barrier integrity. Undetected glove microperforations are a frequent occurrence. Microorganisms can penetrate gloves via microperforations under conditions of normal use. Puncture occurrence is directly related to duration of wearing and puncture hazards of different procedures. With the interior of gloves presenting a warm, moist environment for microbial growth, it is easy to understand why glove leaks would double-cross-contamination risk. Handwashing is an important first step before every glove use, but preventing glove leaks is critical to ensure the final barrier between hands and foods is maintained because even with a prior hand wash, interior glove counts of bacteria can be more than a million organisms.
Food poisoning is the worst consequence that can come from improper food handling, given that it can lead to death in severe cases. On the professional front (restaurants, diners, etc.), this can lead to further consequences. If any of your food is handled improperly - be it in storage, preparation or cooking - and someone falls ill (or worse), then it could lead to any of the following scenarios:
- A negative mark on your business’s reputation, branding and/or reviews
- Fines for breaches of proper health and safety practices
- A significant drop in patron numbers
- Legal proceedings - in a notorious case, KFC had to pay approximately $8.3 million to a girl who suffered significant brain damage due to sustained food poisoning from one of their franchises
- Financial ruin
- Loss of business
- Workman’s comp claims
While you may think some of these could be unlikely, these are some of the very real - and often very likely - consequences that can result if your business is found responsible for causing food poisoning due to improper food handling.
References
https://www.fda.gov/media/110822/download
https://www.initial.com/blog/gloves-vs-no-gloves-the-transmission-of-pathogens/
https://blog.eagleprotect.com/fda-states-gloves-may-be-source-of-cross-contamination
https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/retail-food-protection
https://www.cannonlogistics.com.au/blog/the-consequences-of-improper-food-handling/
https://www.allenandallen.com/do-i-need-a-lawyer-for-food-poisoning/
https://the-injury-lawyer-directory.com/contaminated-food-claims-lawyer-2/
https://foodpoisoningbulletin.com/2012/facts-about-food-poisoning-and-the-law/
https://blog.eagleprotect.com/what-happens-when-disposable-gloves-fail
https://www.who.int/foodsafety/publications/foodborne_disease/outbreak_guidelines.pdf
https://www.foodbeast.com/news/glove-prep-cross-cont/
Ewen-Todd-Food-worker-paper-8.pdf
https://blog.eagleprotect.com/are-you-paying-for-ripped-food-safe-gloves
https://blog.eagleprotect.com/why-medical-grade-disposable-gloves-are-essential-for-food-safety