For nearly 2 years, the food industry has been left to wonder precisely how the U.S. Food and Drug Administration (FDA) will implement the Food Safety Modernization Act (FSMA). This is in part because the federal government has yet to finally promulgate four regulations at the heart of FSMA that involve risk-based preventative controls, produce safety and foreign supplier verification. Those regulations, although long overdue, remain under Office of Management and Budget (OMB) review.
In late November 2012, FDA added to that mix, and perhaps the delay, tendering for OMB scrutiny a proposed regulation regarding accreditation of third-party auditors who will conduct food safety audits of foreign entities, including foreign facilities involved in the food import supply chain. FDA posits that this regulation provides another important step toward assuring consumers that imported foods are safe; accredited auditors would expand FDA coverage, utilizing identified standards to complete international food company safety audits.
At this juncture, it may be a fool’s errand to surmise when this newly proposed regulation, much less the prior pending proposed regulations, will issue. OMB apparently takes issue with some aspect of those proposed regulations, and promulgation of an appropriate rule by which to accredit third-party auditors may prove no less problematic. When those rules finally are released for public comment, it will be important for food companies to review and analyze them and, were appropriate, submit comments. In that way, food companies can help shape the very rules that will control their operations and impact their success.
This is not to say that food companies are without means for understanding how FDA will utilize FSMA. Far from that case, on November 26, 2012, FDA for the first time exercised its FSMA-provided authority to suspend the registration of Sunland, Inc., a New Mexico processor of nut-based products. Notably, prior to FSMA, FDA required a court order to stop companies from selling contaminated food. That court-involved process often ate up critical time and undermined FDA efforts to prevent foodborne illness outbreaks.
Here, FDA moved more swiftly under FSMA, although not before scores of consumers became ill after eating Sunland, Inc. product—widespread illness that full implementation of FSMA-required preventative and risk-based food safety measures is supposed to prevent. Regardless, it is clear that FSMA provides FDA authority to suspend a company’s registration where FDA determines that it is reasonably probable that food manufactured, processed, packed, received or held by the facility may cause serious adverse health consequences or death to humans and/or animals. The penalty for such an FDA finding is extreme: It effectively shuts down the facility because the facility is prohibited from introducing food into domestic and international commerce and from importing food.
An affected facility is not without an avenue for remedy. First, it may challenge FDA’s determination, but it must do so quickly, submitting within 2 days (absent FDA agreement to a longer period) a written a demand that an informal hearing on the suspension order is warranted because circumstances exist that show a genuine and substantial issue of fact as to the grounds for the suspension. Second, where no informal hearing is requested, or the affected company does not meet its burden at the hearing, the affected company may petition for reinstatement after demonstrating that it has taken corrective action to remedy the health and safety conditions cited by FDA.
Whether FDA’s first use of its suspension authority truly portends a more proactive FDA on the near horizon remains to be seen. However, given the gravity of a facility registration suspension order, and the extremely short period of time within which that suspension process initially operates, food companies would be prudent to take heed of important lessons that can be gleaned from the Sunland suspension, including:
• Implementation of appropriate hazard analysis and risk-based preventative controls;
• Implementation of a document retention policy that carefully organizes and maintains company and supply chain information; and
• Preparation of a plan by which the company is to marshal facts and information and prepare a response should FDA inspect for contaminated foods or issue a suspension order.
In short, proper preparation is likely to help a food company head off product contamination and a related foodborne illness outbreak in the first place and, as a result, forestall need for any unscheduled FDA investigation. For the unprepared food company, in contrast, FDA’s ability to suspend its registration without court order may have a devastating and perhaps fatal impact on the company.
John T. Shapiro and Jason R. Klinowski are attorneys and members of the Food Industry Team at Freeborn & Peters LLP (Chicago).
Sunland, Inc. Suspension over Food Contamination May Offer Clues on How FDA Will Utilize FSMA