For the past three years, the major story in food safety has been the enactment and subsequent steps toward full implementation of the FDA Food Safety Modernization Act (FSMA). However, the changes FSMA brings to the food safety regulatory structure are so significant and complex that FDA has been unable to implement most of its provisions by the statutory deadlines.
As background, FSMA was signed into law by the president on Jan. 4, 2011, and it requires FDA to move from a food safety approach that reacted to potential harm after an illness outbreak or a finding of adulteration to a preventative framework that identifies potential threats to the food supply and acts to counter them before any harm occurs. To that end, FSMA grants FDA new authority, such as a mandate to require science‐based preventive controls throughout the food supply chain and enhanced authority regarding inspection, compliance, outbreak response and recalls.
FSMA’s own terms required FDA to implement many of the provisions by July 2012, but the agency has been unable to meet its deadlines. In an effort to force FDA to expedite the implementation of FSMA, two public interest groups took the unusual step of suing the agency in federal district court. The public interest groups prevailed and the court held that, among other things, FDA must publish all FSMA final regulations no later than June 30, 2015.
Consequently, 2014 will see the food industry and others reviewing FDA’s proposed rules and, in turn, preparing and submitting comments to the agency.
- FSMA was signed into law by President Obama on Jan. 4, 2011
- It requires the FDA to move from a reactive food safety approach to a preventative framework that identifies potential threats to the food supply and acts to counter them before any harm occurs.
- FSMA grants FDA new authority, such as a mandate to require science‐based preventive controls throughout the food supply chain
FDA’s proposed rule implementing FSMA’s mandate for preventive controls for human food (FSMA section 103) continues to generate the most controversy and commentary. Among the provisions that have been objected to are exemptions to safety standards for small businesses and “qualified facilities.” Many comments regarding these provisions argue that food safety provisions should apply to all businesses in the food supply chain. However, smaller businesses argue that the costs imposed by the proposed rule would dramatically increase costs and force many of them to close their doors, even if the currently proposed exemptions are part of the final rule.
Another controversial issue is FDA’s proposed definition of “farm mixed-type facility.” As currently proposed, those facilities must implement both the preventive controls for human food and the produce safety standards (FSMA section 105). Many affected businesses object to the overlapping coverage of these rules. In addition, industry comments have raised many other issues that will impact FDA’s further efforts to implement this rule.
USDA’s Food Safety Inspection Service (FSIS) has not been as active as FDA, but its plans for 2014 are significant. FSIS’s primary goal is to keep the commercial supply of meat, poultry, catfish and processed egg products safe. To that end, FSIS has recently released the Salmonella Action Plan.
FSIS has described Salmonella contamination as “the most pressing problem it faces.” Consequently, the plan is comprehensive and includes specific provisions to (1) issue a proposed poultry slaughter rule; (2) revise the agency’s Salmonella sampling plans; (3) train FSIS inspection program personnel to effectively combat Salmonella; (4) issue a directive for sanitary dressing in hogs; (5) consider the publication of more information regarding the Salmonella performance categorization of FSIS-regulated establishments; (6) develop standards for comminuted poultry products, poultry parts, hog carcasses, and pork products; (7) consider the impact of pre-harvest activities on Salmonella contamination; and (8) create more effective communications to consumers regarding Salmonella. FSIS estimates that most of these provisions will be completed in 2014.
Detailed discussion of FSIS’s entire Salmonella Action Plan is beyond the scope of this article, but some of its provisions merit additional attention. FSIS considers the modernization of poultry slaughter inspection through a proposed poultry slaughter rule to be central to its efforts against Salmonella contamination and it estimates that it will result in at least 4,200 fewer Salmonella illnesses each year. Expect this proposed rule to be issued in the third quarter of 2014.
FSIS’s focus is not limited to poultry, however, as the agency finds that pork products also contribute to Salmonella illnesses. FSIS believes that decreasing sanitary dressing problems in establishments that slaughter hogs could decrease Salmonella contamination on carcasses. The agency estimates that it will issue a directive for verification activities related to sanitary dressing in hog slaughter establishments in the fourth quarter of 2014.
In sum, FDA’s food safety activities for 2014 will be dominated by the continued implementation of FSMA, but FSIS will also be busy implementing its ambitious Salmonella Action Plan.