Congress is on the brink of passing the Food Safety Modernization Act (“the Act”), widely heralded as the most significant reform of the nation’s food safety laws in decades. The Act, which passed the Senate last week but faces procedural and legislative roadblocks in the House of Representatives, promises to usher in a heightened era of federal oversight for food manufacturers by granting the FDA new power to enact food safety regulation and to halt operation of food facilities because of safety concerns.

Key Provisions in the Act

The Act’s reforms are extensive, and require comprehensive scrutiny for businesses in the food industry. Among many significant provisions, the Act:  

  • Requires owners of food facilities to implement detailed “hazard analysis and risk-based preventive controls,” to prevent “hazards that could affect food” and “provide assurances that such food is not adulterated under section 402 or misbranded under section 403(w),” subject to regulations the FDA shall promulgate within 18 months after the Act’s enactment. See Food Safety Modernization Act, S. 510, 111th Cong. § 103 (as passed by Senate, Nov. 30, 2010).  
  • Requires businesses cultivating produce to comply with “science-based minimum standards for the safe production and harvesting … of [certain] fruits and vegetables,” subject to notice and comment rulemaking by the FDA beginning within 1 year after the Act’s enactment. Id. § 105.  
  • Requires food importers to verify that imported food is produced in compliance with certain of the Act’s requirements applicable to domestic food manufacturers, subject to regulations the FDA shall promulgate within 1 year after the Act’s enactment. Id. § 301.  
  • Provides for the increased safety inspection by the FDA of “high-risk facilities,” id. § 201; increases the FDA’s records-inspection authority, see id. § 101; and directs the FDA to establish “pilot projects” to enhance the tracking and tracing of food and recordkeeping, in coordination with the Secretary of Agriculture, representatives of state departments of health and agriculture, and the food industry. Id. § 204.  
  • Enables the FDA to suspend food facilities’ registration and lawful operation if the FDA “determines that food manufactured, processed, packed, received, or held by a facility … has a reasonable probability of causing serious adverse health consequences or death to humans or animals[.]” Id. § 102. The Act provides for an informal hearing to contest the suspension of a facility’s registration. Id. § 102(b)(2).

Enables the FDA to order the mandatory recall of an article of food if the FDA determines “there is a reasonable probability that an article of food … is adulterated under section 402 or misbranded under section 403(w) and the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals[.]” Id. § 206. The Act provides for an informal hearing to contest a recall order. Id.

Legal Impact on the Food Industry

The Act substantially increases the FDA’s authority to ensure the safety of food products. Under the Act’s new regulatory framework, food manufacturers are prohibited from maintaining facilities that fail to implement hazard analyses and preventive controls. The FDA may suspend the registration and lawful operation of a food facility if the Agency determines the facility’s products have a reasonable probability of causing serious adverse health consequences. Similarly, the FDA may order the mandatory recall of food products if it determines the products have a reasonable probability of causing serious adverse health consequences.

Still, the Act leaves much unclear. Many of the Act’s key provisions rely upon FDA regulations to be promulgated at a future date. Food manufacturers may also have legitimate concerns regarding the extent to which they must simultaneously comply with federal regulations and requirements imposed under state law.

The scope of federal preemption of state law claims also remains unclear. The Act does not include an express preemption provision, although the Act’s safety provisions concerning cultivation of produce appear to allow states and foreign countries to vary from the FDA’s regulations only where the state or foreign country requests and is granted approval by the FDA. See id. § 105. Requirements imposed under state law may arguably be impliedly preempted where they conflict with federal requirements imposed under the Act, although such an argument would likely depend on the particular requirements at issue.

What the Future Holds

The Act is not yet law. Last year, the House of Representatives passed its own food safety bill and, at a minimum, now faces the task of reconciling that bill with the version passed by the Senate. More problematically, as of this article’s printing significant debate had arisen as to whether the bill, as a procedural matter, can originate in the Senate, placing the passage of any food safety bill this year in some doubt. The House, Senate, and President Obama, nonetheless, have expressed support for comprehensive reform of the nation’s food safety laws and proponents of the Act remain hopeful that it will be enacted by the end of 2010.

Even if a compromise bill is passed, the full impact of the Act on the food industry will remain uncertain for some time, both because the safety regulations the Act empowers the FDA to promulgate have yet to be written and because of the potential uncertainty surrounding the legal provisions discussed above. If, as proponents hope, the Act is passed without significant change, it will herald a new age of heightened FDA authority over the food industry. Manufacturers will likely focus their attention on devising legal strategies for managing their risk in an environment of increased regulatory scrutiny