F.D.A. issues 'final rule' on administrative detention

by Jay Sjerven
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The U.S. Food and Drug Administration on Feb. 4 announced a final rule amending the criteria for administrative detention to prevent potentially unsafe food from reaching the marketplace. The final rule took effect on Feb. 5 when it was published in the Federal Register. The rule made the criteria for administrative detention consistent with changes to the Federal Food, Drug, and Cosmetic Act mandated by the Food Safety Modernization Act.

The final rule adopted the interim final rule “Criteria used to order administrative detention of food for human or animal consumption,” published in May 2011, without change. The interim final rule amended the criteria for ordering administrative detention to permit the F.D.A. to administratively detain a food it believes is adulterated or misbranded. The interim final rule became effective in July 2011.

Before the passage of the F.S.M.A. in January 2011, the F.D.A., as authorized by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, was able to detain a food product only when it had credible evidence that the product presented a threat of serious adverse health consequences or death to humans or animals. Under the new final rule, the F.D.A. may detain a food if it believes that the food is adulterated or misbranded, a lower threshold that provides the agency greater flexibility. The final rule states the F.D.A. may keep detained products out of the marketplace for a maximum of 30 days while it determines whether to take further enforcement action, such as seizure.

The F.D.A. noted it received and considered 12 “responsive” comments to the interim final rule, but the agency did not as a result make any changes to the regulatory language included in the interim final rule and that was adopted without change in the final rule.

Some commenters requested the F.D.A. clarify what it meant by the phrase “reason to believe that an article of human or animal food is adulterated or misbranded.” The F.D.A. said decisions on whether it had reason to so believe “will be made on a case-by-case basis because such decisions are fact specific.” The F.D.A. said it would consider the individual facts in each particular situation to inform its reason to believe that an article of food was adulterated or misbranded.

“Because such decisions are fact specific, F.D.A. has not, therefore, amended the regulation to provide additional explanation of the criteria for ordering administrative detention,” the agency said.

Commenters stated the F.D.A. should implement the new administrative detention criteria in a consistent, judicious way, and some stated the agency should restrict the use of administrative detention of food to food that significantly adversely affects human or animal health and that the F.D.A. would consider classifying as a Class 1 recall.

The F.D.A. responded, stating it intends to use administrative detention “in a manner that is consistent with and furthers the prevention-based goals of F.S.M.A. and the agency’s public health mission.” It acknowledged the new criteria provide the agency with more flexibility in its use of administrative detention and said it will use the tool as appropriate.

“The agency will also continue to use its advisory action tools, such as warning letters and untitled letters, to achieve voluntary corrective action to address adulteration or misbranding violations, as appropriate,” the F.D.A. said.

One commenter asked the F.D.A. to clarify which party would be responsible for the costs associated with an administrative detention, such as storage or moving costs, or with the disposal of the detained products by means of reconditioning, re-export or destruction.

The F.D.A. said, “The responsibility for paying the storage costs of administratively detained food is a matter to be resolved between the private parties involved. F.D.A. is not liable for these costs.” The F.D.A. added an owner or agent in charge of the place where the food is located may request modification of a detention order to allow the food to be moved or destroyed if they do not want to store it.

F.D.A. extends comment period on information-collection provisions associated with two proposed rules

The U.S. Food and Drug Administration on Feb. 15 announced it was extending to May 16 the comment period of the information-collection provisions associated with the proposed rules on "Current good manufacturing practice and hazard analysis and risk-based prevent controls for human food" and "Standards for the growing, harvesting, packing and holding of produce for human consumption" that appeared in the Federal Register of Jan. 16.

The F.D.A. initially requested comments by Feb. 15 on the information-collection provisions that are subject to review by the Office of Management and Budget under the Paperwork Reduction Act of 1995. The F.D.A. extended the deadline for the comment period in response to requests for an extension, in order to allow interested persons additional time to submit comments. May 16 also is the deadline for submitting comments on the proposed rules themselves.

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