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Recalls happen for a variety of reasons. Most of the time a recall is initiated due to some form of contamination. Usually when we think food contamination, we think biological. The most common foodborne illness is Salmonella, a harmful bacterium, though Norovirus is another that may come to mind. While biological contamination (such as Listeria monocytogenes, E. coli, Botulinum toxin, etc.) is one reason a food product might be recalled; there are several other reasons a food product may be recalled, like recalls for foreign objects.
If you have consumed a product that was recalled for foreign material contamination and have fallen ill, contact our foreign object contamination lawyers. The Lange Law Firm, PLLC is dedicated to helping victims recover the compensation they deserve. You may be eligible to collect damages through a foreign objects contamination lawsuit.
Here are some ways recalls are initiated, including those for foreign objects:
When food products are imported into the United States, they must be inspected at the Port of Entry. Some countries are not allowed to import certain foods into the United States due to established risk factors. Sometimes these products slip through the cracks and are discovered at a later inspection. If the un-inspected or illegal product has made its way into American consumer hands, the product must be recalled.
Most meat products require inspection from the United States Department of Agriculture (USDA). Beef and poultry products require an inspector present at slaughter if they plan to resale the meat. A product without this required inspection is subject to recall.
Sometimes shelf-stable foods are at risk from deviation from protocol. This involves heating temperature or time in most cases. When a company reviews their records and discovers a problem, they will recall affected product in the hopes that any product that might be contaminated or subject to contamination are taken back before anyone becomes sick.
A food product that contains foreign objects – an unintended non-food product is subject to recall as it may cause bodily harm to the consumer. This could be anything from bone fragments, to glass, plastic, metal pieces, or some other hard or sharp object that ends up in the food product and shipped out to consumers.
Foreign objects can be classified in two ways: intrinsic – referring to something naturally occurring in the food product such as bones, stems, or pits OR extrinsic – referring to objects that are not normally found in food such as metal or plastic.
There 5 basic sources of foreign objects contamination ranging from the farm production to the consumer.
According to the US Food and Drug Administration (FDA) the FDA Health Hazard Evaluation Board evaluated approximately 190 cases of such hard or sharp foreign objects in food from 1972 to 1997. Data drawn from those cases lead the board to determine that objects that are less than 7 mm (maximum dimension) rarely cause trauma or serious injury outside of special risk groups – infants, surgery patients, and the elderly. Additional scientific and clinical literature was gathered to support this conclusion. As a result, the board established Defect Action Levels for unavoidable defects that are smaller than the elevated risk of 7 mm.
Some food products naturally have hard or sharp components in them. Take bones in seafood or shells in nut products for example. The board determined that these types of foreign objects, though not edible or intended to be consumed in the food, are unlikely to cause injury due to consumer expectation of potential contamination of those particular products. One exception was noted, however. When the food label indicated that the hard or sharp component had been removed from the food such as pitted olives, if the food contained pit fragments it would more likely cause injury as it was no longer expected. The FDA established those Defect Action Levels for these types of unavoidable defects in their Compliance Policy Guides.
These levels are assessed based on risk factor and nature of potential foreign material contaminant and specific for each food type and expectation level. Defect Action Levels have come under fire in the past, as they give food producers a pass on including potentially harmful objects in their food products.
Quite a bit can go wrong when a person consumes something that is not meant for consumption. Metal shavings, hard plastic pieces, glass shards each have their own risk factors. The most common foreign material reported based on FDA consumer complaints that resulted in illness or injury was glass. Where the hard or sharp object ends up will also determine what type of injury is possible.
Consuming food contaminated with hard or sharp foreign objects may cause serious injury to parts of the digestive tract that it comes in contact with. These include, but are not limited to:
The mouth and teeth may become injured or damaged as a result of consuming hard or sharp foreign objects. These injuries include, but are not limited to:
The most common injury reported based on FDA consumer complaints was mouth or throat lacerations.
Food producers have many opportunities to intervene and minimize foreign material contamination risk. In fact, these interventions should be a part of any food producers Risk Assessment. Some activities include the following: supplier approval programs, pest management, glass and brittle plastic controls, cleaning and sanitation programs, building management, preventative maintenance programs, pallet management, equipment and utensils, personnel hygiene, and having Standard Operating Procedures.
By being picky on where food manufacturers source their food supplies, they have a greater chance of getting foods free from foreign material contamination. Food manufacturers may mandate that suppliers pass certain criteria that will rule out contamination by foreign objects. These requirements may include passing the product through a metal detector or screen prior to packaging. This may not work 100% of the time, but requiring a supplier to be as vigilant as the manufacturer is a big first step.
Pest management is an important part of any food manufacturing facility. While insect parts might not make someone sick, it is certainly not a good idea to have in your final product. An appropriate pest management program must be in place. Many raw agricultural commodities are received outdoors – that is where they come from. Birds, insects, and rodents are a consistent concern. Proper sanitation in the environment and interventions such as washing will minimize the risk of pest or pest parts ending up in the final product.
A proactive control for glass and brittle plastics is essential to minimizing foreign material contamination. No glass or ceramic products should be used in the food processing area or warehouse at any time. For large manufacturing plants, strict adherence is required. Windows and light fixtures should be shatterproof or covered with plastic to contain any breakage. If glass is required for production, a thorough inventory of glass products should always be maintained.
Cleaning and sanitation are obvious ways to minimize risk of foreign material contamination. Less obvious, however is hat the cleaning and sanitizing program must also include inspection of the equipment as it is being cleaned. Damaged equipment, no matter how clean, can generate foreign material contamination.
A facility that is in good physical condition will help minimize product contamination with foreign material. Older facilities pose an increased challenge as they may contain wooden ceilings or floors that require painting or sealing. Leaks may cause a contamination event. Old, peeling paint might make its way into the final product. For this reason, building maintenance issues must be identified and maintained regularly.
While preventative maintenance might be the least appreciated it helps keep equipment operating properly and protects the company’s assets. Proper preventative maintenance can help prevent loss of nuts, bolts, blades in cutters, and any other piece from equipment from breaking or coming loose, leading to foreign material contamination.
Pallets can get dirty. And gross. They are the surface that keeps the product together, but also touches the ground instead of the product. When moved around from place to place and holding different types of items, they can be a source for both biological contamination and foreign material contamination when they become damaged. Pallets should be inspected, stored appropriately, and cleaned. Splintered or broken pallets with loose boards or nails should be set aside for repair or recycling.
Equipment and utensils should be properly cleaned, maintained, sanitized, and inspected to ensure that they are not a source of contamination. Breaking or broken equipment can become lost in the food product, leading to foreign material contamination.
Personnel hygiene is a huge part of contamination management. This applies to biological and foreign objects:
Each manufacturer should have Standard Operating Procedures that are implemented every day. This could apply to how the product is made, how equipment is used, and how maintenance is performed.
Generally, ingested foreign objects will pass naturally through the digestive system somewhere between 4 to 7 days in about 80 to 90% of cases. It is estimated that around 1 to 5% of foreign material contamination cases will result in injury.
According to the FDA Compliance Policy Guide, sharp objects between 7 and 25 mm found in Ready-to-Eat foods are dangerous and meet the “criteria for direct reference seizure.” Their criteria for recommending legal action was very specific. If the food product requires additional preparation (not ready-to-eat) hard or sharp objects must be between 7 and 25 mm in size. This drops to anything less than 7 mm if the product is intended for special-risk groups such as children and the elderly. Anything over 25 mm in length also falls under this recommendation without any stipulations.
Always contact your health care provider if you feel you have consumed something contaminated with a foreign material. If you have consumed a product that was recalled for foreign material contamination, it is a good idea to see your health care provider to be sure that no injury took place. After receiving medical attention, contact us. Our foreign object contamination lawyers offer free consultations.