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Hold It There
An examination of the FDA’s increased administrative detention authority
by Cathy Crawford and James Dobbs
Under FSMA, the FDA has increased authority to use administrative detention as an enforcement tool. For this reason, companies that manufacture, prepare, pack, or hold food should maintain strong record-keeping practices.
According to the current criteria of the Food, Drug, and Cosmetic Act, the FDA can 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 rule was amended under the FSMA, giving the agency greater authority to use detention as an enforcement method. The new rule changes the 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.
The goal of the 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 their safety can certainly reduce risk. The decision-making skills of those implementing administrative detention, combined with a company’s ability to create and maintain good records, will determine whether or not detention is used appropriately to protect health while avoiding unnecessary burdens, shipment delays, and added costs.
Historically, the majority of FDA administrative detention decisions appear to have been appropriate. According to information published in the Federal Register, the FDA estimated that up to 48% of detained imported foods may have been held because time was needed to determine the facts, and the product was later released as acceptable. This estimate implies that 52% of detained imported food was not released after detention. In other words, after investigation, 52% of the detentions were found to have been justified. For the public, this means that it is likely that a majority of the FDA’s administrative detentions rightfully protected 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 issuing a 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 decision-making skills similar to those used for imports, the same 48% rate of potentially unnecessary detentions may result. Industry and government should share the goal to reduce that percentage in order to ensure that the vast majority of detention actions are necessary and controls are effectively implemented.
The FDA indicates that 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 being potentially subject to a Class II recall. Detention decisions will be made on a case-by-case basis. The Federal Register indicates that each circumstance is “fact-specific.” Accurately recording, documenting, and ensuring a solid audit trail of the facts is essential to every entity susceptible to such a detention. The amount of time and resources spent gathering the necessary information depends on how well the required audit trail has been maintained and will determine how quickly the product can be released, saving the company the headache and costs of being forced to keep the product from the market.
A concern for companies engaged in manufacturing or holding human or animal foods is that administrative detention actions no longer need to be justified by credible evidence. Rather, 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 decide whether 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.
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 fact and not just belief.
A thoroughly documented food safety system with validated preventive controls—an HACCP plan—is the best way to avoid unnecessary detention. This can only be achieved with appropriate training, organized record-keeping systems, and process management to ensure consistent enforcement of policies. Companies should review their food safety plans or have a third party do so, paying specific attention to record-keeping to ensure communication of accurate and complete data. Electronic quality management systems are highly encouraged, based upon the potential for human error and the costs associated with managing a system of manual controls.
When reviewing a 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 a “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 occur once per shift, up to eight hours of production would be suspect.
- Records are to be completed in ink or signified electronically (21 CFR part 11 compliant) at the time of the event, by the person conducting the activity.
- Each recorded activity should include either affirmative or negative results, accompanied by the signature or initials of the person who completed the action. Don’t just record noncompliance. Record evidence of compliance or control as well. For example, a daily sanitation inspection should document acceptable conditions as well as unacceptable ones.
- Following a corrective action, always document a return to control or appropriate conditions. For example, documentation of unacceptable sanitation should be followed by documentation of re-cleaning and re-inspection, including 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 others who store, distribute, import, or produce food can ensure fact-based decisions by using good record-keeping practices and adopting quality systems and technologies that enable such practices to be enforced and embraced.
Cathy Crawford, vice president of HACCP Consulting Group, has a broad range of experience in consulting, food manufacturing, and food chemistry/microbiology laboratories and is a registered auditor for Safe Quality Foods. James Dobbs is a solutions consultant for Qualtrax Compliance Software with emphasis on the food and process manufacturing industry.