Washington Insider -- Wednesday

FDA and Recall Authority

Here’s a quick monitor of Washington farm and trade policy issues from DTN’s well-placed observer.

Beef Checkoff Battle Still Hot Between R-CALF, NCBA

A simmering battle between beef producer groups spilled over this week when a federal court granted R-CALF USA’s motion that could end up expanding its challenge of USDA’s beef checkoff program to possibly 13 more states.

The latest court action resulted in a stinging response from the National Cattlemen’s Beef Association (NCBA), which called the group a “puppet” for animal rights activists and pushed back against accusations the money in the beef checkoff marketing program is being misused.

“R-CALF has become nothing more than a front group for activists seeking to divide the industry, lessen beef demand and drive producers out of business,” said Kendal Frazier, NCBA CEO.

In May 2016, Ranchers-Cattlemen Action Legal Fund, United Stockgrowers of America (R-CALF USA) filed a lawsuit charging USDA with operating the beef checkoff program in violation of the First Amendment by using the federal funds, which compel producers to pay $1 per head for each cattle sold, to fund private speech of the Montana Beef Council.

The group filed the suit after the Montana Beef Council used the funds to support Wendy’s advertising campaign to “promote a product which could contain beef from 41 different countries.” R-CALF argued the checkoff fees were being used to convince consumers that domestically raised beef is no different than foreign beef produced under less stringent procedures.

Courts have upheld a preliminary injunction temporarily blocking producers from paying for the advertising campaigns of the Montana Beef Council without first obtaining their consent.

At the request of R-CALF, the court on Nov. 5 granted a motion to proceed with its case seeking a permanent injunction against USDA and, if successful, the injunction would likely cover cattle producers in the additional states.

The two-page order by Judge Brian Morris, of the U.S. District Court for the District of Montana, also sets a teleconference between the parties for Nov. 7.


Memphis Meats Pitches Solution to Regulating Cell-Based Industry

While the question of how federal agencies will regulate cell-based meats remains unclear, San Francisco-based Memphis Meats, one of the biggest players in the new field, is offering a simple solution.

FDA and USDA could split regulatory responsibilities, and FDA, which already has experience in the cell-based field, could take over regulation of the cell-based meat development process up until the product is “harvested.” And once the product has been developed into a meat tissue, USDA should take over regulation, applying its long-standing expertise in ensuring the safety of meat, says Eric Schulze, Memphis Meats’ vice president of product and regulation.

Schulze, a molecular and cellular biologist and former FDA regulator, sketched that idea while speaking at a Cultured Meat Symposium in San Francisco, Calif.

“FDA has 30 plus years of experience in regulating the safety of processes of using cloned cells on an industrial scale to produce a product. And the safety of those processes should still lie with the FDA,” he stated. And if USDA takes over regulation of the finished tissue product, that would allow each of the agencies to fully employ their regulatory strengths, Schulze suggested.

And with USDA Secretary Sonny Perdue’s recent commitment to have a federal regulatory framework developed for cell-based meats by 2019, the government is already moving in the right direction, Schulze said.

“Inspections and labeling are still being worked out, and that’s sort of the gray area right now,” he said. “But that conversation is rapidly happening. And we are going to hold Secretary Perdue to his commitment in 2019, which is an enormously fast time frame for the U.S. government.”

“We are going to have to figure that out pretty soon, but I don’t think we have answers right now,” Schulze added.


Washington Insider: FDA and Recall Authority

Although USDA has long relied on strong “recall authority” for protection against contaminated products, FDA has been much more reluctant to take such steps. Now, Food Safety News is reporting that “almost eight years after gaining statutory power to mandate food recalls, the FDA is officially publishing information to help industry understand when the agency will use its authority.”

In a guidance document to be released in the Federal Register this week, FDA uses a question-answer format to explain how, when and why the government will force companies to recall food for people and animals.

Congress gave these authorities to FDA as part of the Food Safety Modernization Act, which was signed into law in 2011. A number of provisions in the Act had delayed activation dates, but the FDA was authorized to force food and feed recalls as soon as the legislation was signed into law by the President.

Since 2011, the FDA has used its mandatory recall power three times, FNS says. In 2013 the agency forced the recall of Salmonella-tainted pet treats produced by Kasel Associates Industries; in 2014 it required the recall of OxyElite Pro Dietary Supplements; and in April this year it mandated the recall of all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC after several products were found to contain Salmonella. The agency has been seriously criticized for its reluctance pull back threatening products, and the pace of the recalls.

Recently, Scott Gottlieb, FDA commissioner, told the press that the agency will not be shy about flexing its recall muscles in the future. “Fortunately, most companies collaborate with the FDA to rapidly initiate voluntary recalls of hazardous food products. On average, a recall occurs within four calendar days of the problem being discovered,” Gottlieb said.

“However, we’ve seen cases where companies don’t voluntarily comply even if the products are reasonably likely to cause serious illnesses or death. ...Most of our regulated industry partners share our commitment. But when they don’t, Americans should know that the FDA won’t hesitate to take steps to protect their health.”

The main variable in the mandatory recall equation is whether a food or feed will cause SAHCODHA — that’s FDA talk for serious adverse health consequences or death to humans or animals.

According to the new guidance document, circumstances and/or evidence that can trigger the agency’s recall authority include results from sample analyses, which may include those for raw materials or finished food products and certain sample swabs from the food facility manufacturing environment.

They also include epidemiological data such as foodborne outbreak data directly related to the food product that suggest disease or injuries have already occurred from the consumption of/exposure to the product.

The agency says it will take into account the vulnerability of the population that normally consumes or is exposed to the food product, especially concerning high-risk groups such as infants, toddlers, the elderly, pregnant women, medically-compromised individuals, certain pets, and young livestock as well as the nature of the food product — for example ready-to-eat food, raw, cooked, as well as reportable food registry data and consumer and trade complaints as well as whether the responsible party has failed to initiate a voluntary recall.

The FDA will still give food and feed businesses the opportunity to initiate voluntary recalls before ordering mandatory recalls, according to the guidance document. The document lists several examples of situations when the FDA would consider using its mandatory recall authority.

Previous situations that could have triggered FDA to issue mandatory Class 1 recalls include peanut butter, alfalfa sprouts, and deli products found to be contaminated with Salmonella, under-processed canned chili that contained clostridium botulinum toxin and smoked salmon and pumpkin seeds found to be contaminated with Listeria monocytogenes, as well as products containing undeclared allergens such as milk, peanuts or eggs and baby food that posed a choking hazard and horse feed contaminated with elevated levels of monensin.

And, the agency list included additional detail for contaminants or conditions that would lead to recalls and also noted that if it issues a mandatory recall, it will publicize the recall with alerts and public notices, as appropriate, to provide notification to affected consumers and retailers.

The alerts and notices will include, at a minimum, “the name of the article of food subject to recall, 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,” according to the guidance document.

So, we will see. FDA’s regulatory responsibility is extremely broad and the firms it covers are typically extremely reluctant to go the costly step of recalling products. Still, the Congress has been sharply critical of the agency’s pace of implementation of its new authorities — especially in cases of serious health problems from contaminated products. Criticism of the agency’s willingness to take tough steps to keep or recall dangerous products from the food chain has been growing, and the industry likely will continue to face intense scrutiny over how effectively it uses its new authority — reforms producers should watch closely as they are implemented to maintain the future credibility of the safety of the system, Washington Insider believes.


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(GH/BAS)