IDFA and the National Milk Producers Federation filed a sweeping set of comments last Friday with the Food and Drug Administration on the agency’s proposed rule on current good manufacturing practices and preventive controls under the Food Safety Modernization Act. In general, the comments emphasized that the FSMA requirements and standards should be risk based and promote food safety, the rulemaking should stay within FSMA’s framework of protecting public health, and the enforcement must be consistent and appropriate.
The Preventive Controls for Human Food rule would require food companies, including dairy food manufacturers – whether they manufacture, process, pack or store food – to put in place better controls to reduce the risk of contamination.
One-Size-Fits-All Approach Not Effective
Noting that a one-size-fits-all approach would not be effective, IDFA and NMPF said food companies must be allowed to adapt general requirements to fit the needs of their products and manufacturing facilities. The comments support the extensive need to train FDA inspectors appropriately and called for a process for companies to appeal inspectional findings that they believe are inappropriate, not required by the regulations or not consistent with promoting food safety and protecting public health.
“We support the Food Safety Preventive Controls Alliance as one means of facilitating a common understanding of how FSMA is to be interpreted and applied in the real world setting,” the comments said. “We urge FDA to continue its high level of transparency and collaboration with stakeholders during this transition process.”
The Food Safety Preventive Controls Alliance is composed of members from the FDA, local and state food protection agencies, the food industry and academia. It is funded by a one-year, $1 million grant to the Illinois Institute of Technology’s Institute for Food Safety and Health (IIT IFSH), a nationally recognized leader in food safety. IDFA is pleased to announce that John Allan, IDFA vice president of regulatory affairs and international standards, was recently accepted as a member of the FSPCA Steering Committee.
Requests for Clarification and Revision
IDFA and NMPF urged the agency to make several clarifications and revisions to the proposed rule.
- They agreed that added attention needs to be given to food-allergen/cross-contact issues related to Good Manufacturing Practices but asked FDA to clarify that “allergen cross-contact is not a form of contamination, the agency is not imposing a zero-tolerance standard for allergen management and necessary allergen controls are driven by hazard analysis.”
- They supported making employee training a requirement, provided the requirement is general so company training programs can be tailored to meet individual company needs.
- They opposed FDA’s attempt to “transform FSMA into a traditional HACCP program.”
- They strongly opposed mandated finished product pathogen testing.
- They supported a supplier verification provision but urged FDA to focus on requiring manufacturers to develop a risk-based verification plan that considers the risks presented by both the ingredient and the supplier. They noted that FDA should have access to records demonstrating that the company is conducting verification activities but not have access to underlying records of the activities themselves.
- They strongly supported the proposed exemption for warehouses where the food is not subject to Time/Temperature Control for Safety (TCS). They requested an expansion of the exemption to cover all frozen foods that FDA acknowledges are not typically subject to TCS.
- They strongly opposed requirements that would make companies submit facility profiles with hazards and controls information, and that would provide FDA with remote access to manufacturing and related records.
- The comments showed that FDA’s economic analysis “greatly” understated the expected costs from the preventive controls rule, as proposed. Substantial changes are needed to meet FDA’s vision for the rule to be largely cost-neutral for food companies with advanced food safety systems and for medium-size and smaller companies.
Costs Could Be Substantial
"If FDA does not change these proposed regulations in the final rule in rather significant ways, the requirements would impose very substantial costs without any commensurate benefit to food safety,” the comments conclude. “FDA should seek to minimize such costs and not divert precious company resources away from the central task of assuring food safety.”
FDA has extended the comment period several times, most recently to November 22, 2013. The final rule isn’t expected to be published until June 30, 2015.
For more information, contact Clay Detlefsen, IDFA vice president of regulatory affairs, at email@example.com.