FSMA Foundational Rule Implementation Remains in Flux – What To Do Now?
By John T. Shapiro
The following regulations form the foundation of the Food Safety Modernization Act’s (FSMA) core food safety obligations:
Current good manufacturing practice and hazard analysis and risk-based preventative Controls for Human Food [FSMA § 103(a) and 103(c)]
Standards for the growing, harvesting, packing and holding of produce for human consumption [FSMA § 105(a)]
Foreign supplier verification program [FSMA § 301(a)]
Accreditation of third-party auditors (FSMA § 307)
Preventive controls for animal food [FSMA § 103(a) and 103(c)]
Sanitary transport of food and feed (FSMA § 111)
Protection against intentional adulteration of food [FSMA § 106(b)]
Given the desire to protect consumers from food that causes foodborne illness, Congress directed the U.S. Food and Drug Administration (FDA) to implement these rules on a relatively fast track, in or before 2013. But, as consumers and the food industry each well know, FDA could not meet the statutory-mandated deadlines given the complexities each rule involves.
Frustrated by what they perceived as dawdling, the Centers for Food Safety and for Environmental Health sued FDA, asserting that FDA violated FSMA and requesting that the court do what the FDA would not—set certain rule promulgation deadlines. In April 2013, the court sided with the plaintiffs, ruling that the FDA violated FSMA when it missed the statutorily-set deadlines.
Recognizing the magnitude of the task that Congress set for FDA and that efforts to ensure food safety might be thwarted were the court to arbitrarily set deadlines by which FDA must issue the regulations, the court directed nevertheless the parties to confer and agree on a schedule by which FDA would complete the regulations. But the parties were unable to do so. Therefore, on June 21, 2013, the court set June 30, 2015, as the date by which the seven foundational regulations must publish.
Court intervention may not be the last word on the time frame for implementation of FSMA. FDA has asked the appellate court to extend the date by which FDA must promulgate the final version of the intentional adulteration rule. That rule directs implementation of measures to prepare and protect the food supply chain from intentional adulteration at specific vulnerable points. Although the appellate court has refused to issue an order that would permit FDA to delay issuance of a draft attentional adulteration rule, the Court has set FDA’s appeal on an expedited track. The Court will hear oral argument in March 2014 on FDA’s request for additional time in which to issue a final intentional adulteration rule.
But the date by which FDA must issue the final adulteration rule is not the only foundational regulation under attack. Nor is the only challenge to FSMA implementation taking place in court. The National Association of State Departments of Agriculture (NASDA), for example, has asked Congress to give FDA more time to promulgate the FSMA rules, including issuance of second drafts of the rules for public comment. The preventative control and produce safety rules are of particular concern to NASDA. The Association seeks clarity in interpretation and implementation of the rules, and it asserts that additional study is needed concerning FSMA’s impact on farming operations and food production businesses, generally. In addition to making sure that the rules effectively promote food safety, NASDA argues that time is needed to form the federal-state partnerships that are critical to making FSMA implementation a success.
Similarly, the Produce Marketing Association and United Fresh Produce Association recently submitted extensive comments that question the efficacy of many aspects of the preventative control and produce safety rules. Among other things, the trade associations note the importance of making sure that the regulations establish science-based standards for companies throughout the food supply chain. In short, both trade associations urge Congress to grant FDA the time needed to get it right rather than rush to the issuance of rules that are not sufficient to protect consumer health.
What’s a food company to do with the uncertainty that continues to dog the timeframe for FSMA implementation, much less FSMA requirements? The answer remains clear, even if the regulations do not. Prepare. Broad contours of FSMA appear to be relatively set. It thus is important for food companies to be proactive, even as the FSMA regulations are poked, prodded and, perhaps, tweaked or revised. Now is the time for food companies to assess the entirety of their operations, both internal and with suppliers and customers, including study of science-based standards and food safety trends, identification of potential hazards, creation of a written food safety plan, establishment of preventative control systems and systems to monitor and verify the preventative controls, review of supply chain partners for compliance with food safety standards and retooling of supply relationships where needed, and preparation of a recall and crisis management plan should a disruption occur. In that manner, companies will employ the best practices FSMA embodies and be ready to meet FSMA requirements whenever they may be fully settled and implemented.
John T. Shapiro is partner and member of the Food Industry Team at Freeborn & Peters LLP (Chicago).