FSMA marches on
The tangled web of interrelated proposed regulations and comment period deadlines mandated by the US Food Safety Modernization Act (FSMA) of 2010 continued to move toward final implementation at the close of 2013 as the US Food and Drug Administration (FDA) made several important announcements. Implementation is complicated by the fact that a federal court has ordered that all FSMA rules be made final by June 30, 2015, despite FDA’s assertion that it needs more time to adequately review and write final regulations. (See Inform 25:16–19, 2014.)
The agency’s troubles creating and implementing the massive overhaul of the US food safety system are encapsulated in an FDA announcement made on December 19, 2013. In a blog post, FDA’s Michael Taylor, deputy commissioner for foods and veterinary medicine, began by writing: “You spoke. We heard you.” Input from farmers, Taylor said, led to an FDA decision to revise two of the proposed rules affecting farmers under the Food Safety Modernization Act (FSMA). Revised rules for the proposed regulations—originally released in January 2013—on produce safety and preventive controls for human food will be released early in the second quarter of 2014, he said.
Next, on December 24, 2013, the agency released its proposed rule on food defense. That left only one remaining regulation to be released—a proposed rule on the sanitary transport of food and feed—which was presented on January 31, 2014 just as this issue of Inform was going to press. More information on it will appear in the April issue.
FSMA Rule on Adulteration
“Under the proposed rule on Focused Mitigation Strategies to Protect Food against Intentional Adulteration, a food facility would be required to have a written food defense plan that addresses significant vulnerabilities in its food production process,” explains William Kanitz, president of Scoring System, Inc. in Venice, Florida, USA. Scoring System is the developer of ScoringAg, an online food safety record-keeping system.
“Facilities then would have to identify and implement strategies to address these vulnerabilities,” noted Kanitz.
The aim of the proposed rule is to protect food from intentional adulteration when the intent is to cause large-scale public harm. FDA has identified four key activities within the food production system that are most vulnerable to such forms of adulteration. They are:
- Bulk liquid receiving and loading;
- Liquid storage and handling;
- Secondary ingredient handling (the step where ingredients other than the primary ingredient of the food are handled before being combined with the primary ingredient); and
- Mixing and similar activities.
Under the proposed rule, facilities would be required to review their production systems to determine if they engage in any of these activities or else complete their own vulnerability assessments. Once that is completed, they would need to identify actionable process steps, “which are points, steps, or procedures in a food process that will require focused mitigation strategies to reduce the risk of intentional adulteration,” FDA said.
The cost of the proposed rule to both domestic and foreign firms, according to the agency, annualized over 10 years at a 7% discount rate, is between $260 million and $470 million. The first-year cost is between $520 million and $860 million. The average annualized cost per firm is about $37,000, with initial costs of $70,000. (This is an average per-firm cost, and firms may have more than one facility. The annualized cost for a one-facility firm with 100 employees is about $13,000.) “The expected benefit of preventing a catastrophic terrorist attack on the US food supply is about $130 billion, which means that the benefits of this rule outweigh the costs to Americans if the rule has a 1 in 730 or better annual chance of preventing such an attack,” FDA said in the proposed rule.
Comment Periods Extended
The comment period for the proposed rule on adulteration closes on March 31, 2014. Meanwhile, FDA extended the comment periods for two previously released FSMA proposed regulations. Comments on the proposed rule on food for animals and the draft risk assessment for animal feed operations co-located on a farm are now due on March 31 instead of February 26.