FDA Invites Comment on Draft Mandatory Recall Guidance

The Food and Drug Administration issued draft guidance on mandatory recalls in a May 7, 2015 Federal Register notice and is inviting public comment by July 6. The draft document presents the agency’s current thinking on how the food industry can implement the mandatory food recall provisions the Federal Food, Drug, and Cosmetic Act (FDCA) as amended by the Food Safety Modernization Act (FSMA).

In my experience as a former director of FDA’s Center for Food Safety and Applied Nutrition and of FDA’s Center for Veterinary Medicine, the voluntary system of recalls worked well in almost all situations. Nonetheless, the mandatory recall authority is a significant addition to the agency’s enforcement powers for those rare cases in which companies fail to comply with a request.

FDA’s mandatory food recall authority went into effect as soon as the landmark food safety law was enacted on January 4, 2011. The authority added in Section 423 of the FDCA covers all foods (other than infant formula recalls, which are covered separately under Section 412) that are manufactured, processed, packed, or held at a food facility that is required to register with FDA.

The amended FDCA gives FDA the authority to order a “responsible party” to recall food products if there is “a reasonable probability” that the food is adulterated or misbranded and “will cause serious adverse health consequences or death to humans or animals (SAHCODHA).”

The “responsible party” is the person who submits the registration for a food facility at which the food is manufactured, processed, packed, or held, FDA explains. A “person” is defined as including individuals, partnerships, corporations and associations. So the owner, operator, or agent in charge of a facility who is responsible for submitting the registration is also responsible for implementing and assuring the mandatory recall is performed, the draft guidance says.

The term “food” includes articles used for food or drink for man or other animals, chewing gum, and components of any such article. The term “food” also includes dietary supplements.

Among other topics, the draft guidance describes the process the agency will follow for a mandatory recall. Once it determines that the criteria for a mandatory recall have been met, it will first give the responsible party a chance to voluntarily stop distribution and recall the food. FDA says it will provide the request in writing using “an expeditious method.” If the responsible party won’t comply, the agency may order it to stop distributing the food and it will also give an opportunity for an informal hearing. After these steps, the agency may mandate a recall – and only the FDA Commissioner has the authority to order a recall, the guidance explains.

FDA says it will consider the following factors to assess if a recall is needed:

  • Observations made during inspections of the responsible party or other parties;
  • Results from sample analyses;
  • Epidemiological data;
  • Reportable Food Registry data; and
  • Consumer and trade complaints.

The agency has the authority to collect fees from a responsible party for a domestic facility or importer who does not comply with a food recall order. The fees would cover time spent by FDA conducting the food recall activities, technical assistance, follow-up checks and public notifications. In an August 8, 2014 Federal Register notice, FDA listed its fiscal year 2015 fees for reinspections and for non-compliance with a recall order, which will remain in effect through September 30, 2015 and will be revised annually. For FY 2015, the hourly rate is $215 if domestic travel is involved and $305 if foreign travel is required.

To make consumers and retailers aware of recalls, the agency says it will “ensure that a press release is published regarding the recall,” as well as alerts and public notices, as needed. These will include, at a minimum, the name of the recalled food, a description of the risks associated with the food, and “to the extent practical, information about similar articles of food that are not affected by the recall,” the agency says.

Corporate Culture Meets FSMA Compliance at the Intersection of Food Safety

By Amy Scanlin, M.S., EAS Consulting Group, LLC

When the FDA’s overhaul of food safety, the Food Safety Modernization Act (FSMA), is fully rolled out in 2016 it will be the largest change the U.S. food industry has seen. And yet with all the increased requirements for compliance there is one link that is not addressed and cannot be addressed by FDA, that of an organization’s corporate culture and employee internal commitment to getting it right.

How can the industry help further corporate culture and individuals to understand, care about and comply with their personal roles in food safety? Food safety culture is communicated not only through written protocols but through unwritten commitment to compliance and attention to detail. EAS Senior Consultants Tim Hansen, Joan Rosen and Joseph Famiglietti share their thoughts on how corporate culture affects a firm’s understanding and response to FSMA.

Food Safety Leadership from the Top Down

“There is no question in my mind that food safety leadership starts at the top,” says Tim Hansen. “There are several reasons. First, it is usually a regulatory requirement. Second, food safety concepts are not always simple so management has to implement procedures that protect food safety as the average line worker may not understand the concepts and third, a food safety problem can cause great economic harm to the producer. It is leadership’s duty to ensure that this does not happen.”

“A food company needs to have a continuous program in place to keep their employees involved with food safety,” adds Joe Famiglietti. “A problem that I’ve seen over the years is the highest ranking officer delegates quality control and training functions to certain employees and holds them responsible for ensuring these programs are successful. CEO’s need to get more involved in product safety and demonstrate their involvement to their employees. Employees need to know that food safety is critical to their jobs and that company management is playing an active role in implementing programs to ensure their products do not adversely affect the public.”

The culture of an organization plays a role, Hansen explains. “If all employees feel like they are part of the organization and the firm treats everyone fairly there is a good chance that employees will go the extra mile. Accomplishing food safety goals can be problematic when there isn’t a highly engaged work force.”

“Employees will care more about food safety when management demonstrates leadership by ‘walking the talk,’” says Joan Rosen. “Simple steps can go a long way to build trust and drive food safety commitment.” She also says that consistent communication and actions will help to convey the company’s food safety mission and vision. This can include posting reminders around the facility, or incentives for sharing examples of food safety practices and improvements with peers.

Training and Compliance – Lessons from HACCP

Hansen cites compliance lessons learned by FDA during the implementation of the 1997 Seafood HACCP rule. “Almost all the processors had findings on the FDA 483 form,” he says. Some firms clearly did not do their due diligence in conforming to the new regulations but most of problems were due to the sheer complexity of the new requirements. The processors did not really understand what FDA expected. FDA had a big learning curve in how to communicate these complexities and have largely succeeded.”

FDA is drawing on it’s experience with HACCP as it prepares to roll out new rules under FSMA. But companies will need to understand that simply conducting a hazard analysis and preparing a written HACCP plan may not be enough,” says Famiglietti. “They may need to take a closer look at their raw material suppliers and conduct more product testing and environmental monitoring to assure they are producing a safe product.”

“A lack of training is frequently the cause of errors,” says Rosen. “Training is not just a matter of sitting people down, explaining a set of instructions and then signing a paper saying ‘I attended and have been trained.’ Verifying the effectiveness of training is just as important or perhaps more important than the training itself.”

Getting it Right – Low Acid Canned Foods

Hansen, who was a Director in FDA’s Office of Seafood and the Director Seafood Inspection Program at NOAA Fisheries prior to joining EAS shares one of his many favorite examples of industry getting it right. “In the 1980’s there had been a couple of botulism outbreaks in canned salmon. These events threatened the viability of this product as consumers were justifiably wary.”

With a few notable exceptions, the industry “really rallied around the principles of food safety for Low Acid Canned Foods,” he says. “Everyone from the President of the companies to the workers on the line became very aware of the hazards associated with canning salmon and the possibility of a botulism outbreak and many important steps were taken to ensure food safety… Everyone involved in the salmon canning process understood that they needed to do more, from the line workers to the company management, to the trade association and government regulators. It is a success story for food safety since it is been over 35 years since there has been a food safety outbreak [in that industry].”

Sometimes food safety is as simple as a choice. As FDA and industry work together to further implementation and understanding of FSMA, remember that with buy-in from all levels these guidance documents will move from merely words on paper to a living document. Staying vigilant to the importance of everyone’s role will have a significant impact.