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Cathy Crawford

FDA Compliance

When ‘Reason to Believe’ Halts Food Production

Sloppy record-keeping could trigger the FDA’s administrative detention

Published: Monday, August 22, 2011 - 13:35

As of July 3, 2011, the Food and Drug Administration (FDA) has increased authority to use administrative detention as an enforcement tool. For this reason, companies that manufacture, prepare, pack, or hold food should ensure strong record-keeping practices.

Under the current criteria of the Food, Drug and Cosmetics Act, the FDA may order the detention of human or animal food where there is credible evidence or information indicating an article of food presents a threat of serious adverse health consequences or death to humans or animals.

This new rule, which is amended under the Food Safety Modernization Act (FSMA), changes the Food Drug and Cosmetics Act criteria to allow the FDA to order detention if there is reason to believe an article of food is adulterated or misbranded. Foods can be detained for 20 calendar days with a possible 10 calendar-day extension, if needed.

Fact-specific detention

The goal of administrative detention of foods is to protect public health and prevent potentially harmful products from being consumed or used. Detaining products where there is doubt concerning safety certainly can reduce risk. The decision-making skills of those implementing detention, combined with the ability of companies to create and maintain good records, will determine if detention is used to appropriately protect health while avoiding unnecessary burdens, shipment delays, and added costs.

Most FDA detention decisions historically appear to have been appropriate. According to information published in the Federal Register, the FDA has estimated that, of the imported foods that were detained, up to 48 percent were held because time was needed to determine the facts, and the product was later released as acceptable. This implies that 52 percent of detained imported food was not released after detention. In other words, after investigation, 52 percent of the detentions were justified. For the public, this implies that a majority of the FDA administrative detentions rightfully acted on public-health concerns.

These estimates are based on imported product because the FDA has not used administrative detention for domestic foods. Other methods have been used, including voluntary recall, instituting a seizure action, or referring the matter to state authorities. The prior use of these other enforcement methods makes it difficult to predict how often the detention of domestic product may be used. If future FDA detentions of domestic products are based on similar decision-making skills as those employed for imports, the same 48 percent rate of potentially unnecessary detentions may be the result. It should be a shared goal between industry and government to reduce that value to ensure that detention actions are necessary and controls are effectively implemented.

The FDA indicates it is more likely to use administrative detention where this is the most effective enforcement tool available, and where the use of, or exposure to, the product may cause temporary or reversible adverse health consequences. This would be similar to a product potentially subject to a Class II recall. Detention decisions will be made on a case-by-case basis. The Federal Register indicates each circumstance is “fact specific.” Therefore recording, documenting, and accurately ensuring a solid audit trail of the facts is essential.

A concern for companies engaged in manufacturing or holding human or animal foods is that administrative detention actions no longer must be justified by credible evidence. Instead, a “reason to believe” could cause potentially unnecessary product loss or shipment delays of wholesome, legal products. Where facts are missing or inappropriately recorded, the FDA must act upon available information to form a reason to believe the product is, or is not, safe. The old adage “when in doubt, throw it out” might be changed to “when in doubt, consider the use of enforcement tools.” If sufficient doubt about a product or process exists, actions should be considered by the responsible company before the FDA takes action.

Prudent prevention: adequate record-keeping

The FDA has no funds or means of reimbursement for a company facing product loss due to an administrative hold where product is later found to be wholesome. The solution to avoiding potentially unnecessary actions is to ensure case-by-case decisions are based on well-documented facts rather than beliefs. A thoroughly documented food safety system with validated preventive controls (i.e., a HACCP plan) is the best way to avoid unnecessary detention. This can only be achieved with appropriate training and organized record-keeping systems. Companies should review their food safety plans or have a third party do so, paying specific attention to record keeping to ensure the communication of accurate and complete data. Electronic record management systems are highly encouraged.

When reviewing your data system, consider the following:
• If an activity has an impact on food safety, it should be recorded. For example, lack of evidence of appropriate use of sanitizers combined with the presence of a strong odor could lead to “reason to believe” the product is adulterated.
• The frequency of recorded events should be related to food safety and process stability. Be prepared to consider the product or process from the time of an out-of-limits event back to the last acceptable check as unacceptable. For example, if a company checks temperature once per hour, all production for up to one hour could be suspect if the process is discovered to be out of limits. If the same checks are once per shift, up to eight hours of production would be suspect.
• Records are to be completed in ink, at the time of the event, and by the person conducting the activity. Electronic records are also appropriate if the system is password-protected.
• Each recorded activity should include either affirmative or negative results, and a signature or initials of the person who completed the action. Don't record just the noncompliance; record evidence of compliance or control as well. For example, a daily sanitation inspection should document acceptable conditions as well as any unacceptable ones.
• When following a corrective action, always document a return to control or appropriate conditions. For example, the documentation of unacceptable sanitation should be followed by the documentation of recleaning and re-inspection, and include the results of that inspection.

 

These are some of the steps needed to ensure factual communication, which will lead to appropriate decisions and decrease the risk and costs associated with production losses. A reason to believe a product is adulterated could arise from an anonymous call to the FDA reportable food registry, a simple observation, or even a customer complaint. Companies must be prepared to share validated documentation of product status to remove doubt wherever possible.

Administrative detention of foods can be an effective tool if facts support the decisions made. Manufacturers and other organizations in the food industry that store, distribute, import, or produce food can help the FDA make informed decisions by using good record-keeping practices and adopting quality systems and technologies that enable such practices to be enforced and embraced.

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About The Author

Cathy Crawford’s picture

Cathy Crawford

Cathy Crawford has more than 15 years experience in consulting, food manufacturing, and food chemistry and microbiology laboratories. Specializing in food defense programs, she was the instructor for a series of workshops sponsored by the USDA Food Safety Inspection Service (FSIS). Crawford is an enthusiastic trainer who has provided hazard analysis and critical control point (HACCP) guidance and other food-safety training to meat and poultry processors, bakeries, fruit and vegetable processors/packers, and food service establishments. In addition to her contributions within the HACCP Consulting Group LLC, she is also a senior consultant for the Quality Support Group and an adjunct instructor at the Culinary Institute of Virginia. Contact Crawford at foodsafety1@yahoo.com.