Implementation of the Food Safety Modernization Act

Cathy Crawford

As of July 3rd, the Food and Drug Administration (FDA) will have 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.

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.

As of July 3, 2011, the rule is amended under the Food Safety Modernization Act (FSMA) providing greater authority to use detention as an enforcement tool. 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 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.

The majority of FDA detention decisions historically appear to have been appropriate.According to information published in the Federal Register, the FDA estimated up to 48 percent of detained imported foods may have been detained because time was needed to determine the facts and the product was later released as acceptable. This implies 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 a majority of the FDA 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 such as 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 as of July 3, 2011. 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 the vast majority of 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.' 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, 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, 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 in a product or process exists, actions should be considered by the responsible company before the FDA might do the same.

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 and not on beliefs. A thoroughly documented food safety system with validated preventive controls (a HACCP Plan) is the best means 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 only record 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.

  • 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 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 need to be prepared to share validated documentation of product status to remove doubt wherever possible.

Administrative detention of foods can be an effective tool beginning this July, if facts support the decisions made. Manufacturers and others who store, distribute, import, or produce food can ensure this by using good record-keeping practices and adopt quality systems and technologies that enable such practices to be enforced and embraced.

Cathy Crawford has more than 15 years prior experience in consulting, food manufacturing, and food chemistry / microbiology laboratories. She was the Director of Regulatory & Technical Services for a privately owned meat and poultry processing company where she was responsible for regulatory compliance, developing food safety strategies, ensuring appropriate export programs and coordinating recall responses when necessary.

Specializing in food defense programs, she was the instructor for a series of food defense workshops sponsored by the USDA Food Safety Inspection Service (FSIS). She also facilitated national focus group meetings, bringing together industry, trade association and FSIS representatives to produce new model voluntary food defense plans and FSIS Guidance Material.

Ms. Crawford is an enthusiastic trainer who has provided HACCP and other food safety training to a wide variety of businesses including meat and poultry processors, bakeries, fruit and vegetable processors/packers, and food service establishments. In addition to her contributions within the HACCP Consulting Group, she is also a Senior Consultant for the Quality Support Group and an adjunct instructor at the Culinary Institute of Virginia. Contact Cathy at