Senior executives of large food distributors, industry consultants and attorneys, and even FDA officials agree it will take more than simply abiding by the Food Safety and Modernization Act (FSMA) to ensure that unsafe food does not enter the marketplace. “At the end of the day, any regulations, any of your food safety programs, any of your SOPs, are all designed to deliver a specific result—food safety,” said Craig W. Henry, PhD, vice president, Decernis LLP.
“The real challenge is fewer foodborne illnesses, higher consumer confidence in the products that are produced and made available to that marketplace, and a higher degree of confidence in those who help govern, manufacture, deliver, distribute, and retail those products,” Henry told attendees of a workshop at this year’s Food Safety Summit in Baltimore on “Doing the Right Thing—Meeting Consumer and FSMA Food Safety Expectations.”
Jorge Hernandez, senior vice president for food safety and quality assurance at US Foods Inc., said safety and quality have to be part and parcel of any business. US Foods has more than 550 private label suppliers from more than 10 countries, and offers more than 300,000 private label and manufactured products. As a result, “the potential for a problem to be exponentially huge [exists] within a matter of days. To me, it’s not about regulation, but about doing the right things,” Hernandez said.
But for those who fail to grasp the importance of inculcating food safety into every aspect of their business, a senior FDA official outlined the new enforcement powers made available through FSMA, and explained how and when the agency intends to use them. Roberta Wagner, deputy director for regulatory affairs, FDA’s Center for Food Safety and Applied Nutrition (CFSAN), told workshop attendees that a key program goal is to develop and swiftly deploy the fastest, most effective methods for identifying, containing, and eliminating food hazards.
Enhanced Records Inspection
The first of the new tools is expanded authority to obtain and inspect food company records. FSMA Section 101 amended Section 414 of the Food Drug & Cosmetics Act, which itself had been added by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the BT Act). The BT Act gave FDA access to records relating to food produced by a registered facility that the agency “reasonably believes” to be adulterated and presents a threat of serious adverse health consequences or death to humans or animals (SAHCODHA). FSMA expanded the agency’s reach to records relating to “any other article of food” that it reasonably believes is likely to be similarly affected (not including farms and restaurants).
FSMA also gives FDA access to records when it has a “reasonable belief” that an article of food is adulterated, or that the agency believes there is a “reasonable probability” that use of or exposure to an article of food will cause SAHCODHA. “There’s a lot of the food industry where the FDA goes out and does inspections and we had absolutely no authority to review certain records,” Wagner explained. “We will invoke the use of this authority to gain access to those records.”
Having this authority would have been useful during FDA’s investigation of the Peanut Corp. of America during the massive Salmonella outbreak in 2009. “The firm refused to show us records regarding its testing programs and testing results,” Wagner said. “The way the records access authority was originally put out there, we were limited initially to only records that pertained to one line in that manufacturing facility, and only the one that produced the King Nut peanut butter that was identified initially as producing several illnesses in a nursing home,” Wagner told the workshop. “The authority given to us under the BT Act of 2002 was way too narrow.”
The FDA has used its enhanced records access authority several times. During its April 2013 investigation of an E. coli O121 outbreak associated with frozen pizza producer Rich Products Corp., Buffalo, N.Y., the FDA obtained records from a different facility that had milled raw wheat and other flour ingredients. The agency also used the expanded authority in October 2013 while investigating a dietary supplement from USP Labs LLC, Dallas, Texas, associated with reports of liver toxicity. “The records access was quite broad in that case as well,” Wagner said.
Since 2007, FDA has invoked its records access authorities (under the BT Act and FSMA) 26 times in cases when firms refused to turn over records. Wagner noted that FDA may not need to invoke this authority as much in the future because FSMA Section 103, the Hazard Analysis and Risk-Based Preventive Controls, requires food processors and manufacturers to make their records available “promptly” to FDA upon request.
Suspension of Registration
A more powerful enforcement tool is the suspension of facility registration. FSMA Section 102 allows FDA to suspend the registration of a facility when the agency determines that food manufactured, processed, packed, received, or held has a “reasonable probability” of causing SAHCODHA. Unlike the enhanced records access, a suspension order requires the personal approval of the FDA commissioner. One reason is the provision’s implications: A suspension order applies to all operations and facilities associated with a company’s registration, not just the one that may be linked to SAHCOHDA. “It has the effect of an injunction,” Wagner said, because it prohibits a company from introducing any food into commerce, including items produced before or after the suspension order was received.
FDA has exercised this authority twice. In November 2013, it suspended the registration of Sunland Inc., Portales, N.M., following an outbreak of Salmonella in peanut butter that sickened at least 35 people in 19 states. In March 2014, FDA used this authority against Roos Foods Inc., Kenton, Del., a producer of Latin-themed cheese and other dairy products, after an outbreak of listeriosis linked to its soft cheeses products from which one person died and seven others were hospitalized.
“It’s typically not one thing that goes wrong that leads to a problem of this magnitude; it’s a multiple factors that contribute to a problem of this size,” says David Acheson, MD, CEO, The Acheson Group and a former FDA associate commissioner for foods. In the case of Sunland, the FDA had reviewed the facility’s internal testing records and found multiple positive Salmonella results throughout the plant and in finished product during the previous three years, along with other “serious violations” of current Good Manufacturing Practices. Even though Roos Foods had voluntarily recalled its products, FDA invoked the suspension after inspectors found unsanitary conditions in the facility, including rainwater leaking from the roof onto cheese processing equipment, bags of salt, packaging materials, and pooling on food contact surfaces.
“It’s difficult to argue that FDA shouldn’t exercise the option for immediate action when food-contact surfaces are being subjected to a ‘rain storm’ of potential contamination,” Dr. Acheson argues in a recent posting.
FSMA Section 206 for the first time gives FDA mandatory recall authority of food products. The threshold is a reasonable probability that food is adulterated or mis-
branded and evidence that its use or exposure will cause SAHCODHA. A recall order also requires the FDA commissioner’s approval. According to Wagner, a mandatory recall comes at the end of a process. The first step is a verbal request to undertake a voluntary recall. If the firm declines, the next step is a 423(a) letter, formally known as Notification of Opportunity to Initiate a Voluntary Recall. “If the firm refuses to do anything after that point, that’s where you will get an order to cease distribution and notify customers or conduct a mandatory recall,” Wagner said.
While FDA has not invoked this mandatory recall authority, it has issued several 423(a) letters. In 2013, FDA issued a letter to Kasel Associated Industries, Denver, Colo., because of Salmonella in its pet food products. The company initiated a voluntary recall. Earlier this year, the agency sent a 423(a) letter to USP Labs over its dietary supplement linked to liver toxicity. USP also conducted a voluntary recall.
If your company is involved in a recall, “your odds of being inspected skyrocket,” Dr. Acheson says. “You then better ensure that all your food safety programs including your environmental monitoring, cleaning, and sanitation practices are in top-notch shape, and you identified the root cause of the recall and eradicated it. Otherwise you risk inspectors citing you for insanitary condition violations—which are on the rise.”
FSMA Section 207 allows for enhanced administrative detention of food, which means FDA can hold adulterated or misbranded food to prevent it from entering the marketplace. The original threshold granted under the BT Act was “credible evidence or information that the food presents a threat” of SAHCODHA. “We never quite met that threshold” to use the authority, Wagner said. Under FSMA, the standard has been expanded to “reason to believe that an article of food is adulterated or misbranded.” FDA has invoked this authority seven times since 2011 for fishery products, dietary supplements, and other foods, she said.
But as industry representatives agree, hewing to the regulations alone is not sufficient. “We know that FSMA will have a positive impact on food safety, but it cannot be viewed as a magic bullet,” Wagner said. “It will take everyone—food processors, manufacturers, suppliers, third-party auditors and labs, and regulators—acting vigilantly and responsibly to assure that no one segment of the food supply chain or firm is enabling or permitting poor performance, resulting in unsafe food making its way into consumers’ homes.”
Agres is based in Laurel, Md. Reach him at email@example.com.