Pet food manufacturers’ continued efforts to minimize food safety risks in their products are essential.
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Explore this issueJune/July 2016
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One big reason why is because FDA has executed a number of significant policy changes, notes Shawn K. Stevens, a global food safety lawyer and founding member of Food Industry Counsel LLC, Random Lake, Wis. His best four-legged friend is a Yorkshire Terrier named Ruby.
FDA’s policy changes are in addition to the agency writing the Food Safety Modernization Act (FSMA) Preventive regulations, which create complex new requirements for manufacturers of both human and pet foods, Stevens says.
“Those policy changes were developed because, in the last decade, the food industry has witnessed an incredible increase in the numbers of foodborne illness outbreaks and recalls,” Stevens relates. “In 2015 alone, there were more than 500 food products recalled. Many of these recalls were triggered by the presence of harmful pathogens in the food products or resulting outbreaks.”
As part of its enforcement scheme, FDA is now conducting microbiological profiling inside food processing facilities during routine inspections and testing vast amounts of food at retail, Stevens explains. “And, as part of these initiatives, FDA announced that it is now targeting pet food aggressively,” he says.
According to Stevens, regarding FDA policy, while FSMA requires more inspections more often, the agency shift to perform microbiological profiling in food facilities is unwritten. “According to my clients who are scattered across the country, the agency is now doing it as a matter of course, and this has been confirmed to me privately by the agency,” he mentions. “Although FDA routinely samples all foods, including pet foods, at retail, they have in the past announced targeted efforts at pet foods.
As FDA continues to collect and test pet food from retail stores, there is an increasing likelihood that an increasing number of pet foods will test positive for the presence of pathogens, Stevens predicts. “In the event of any positive product sample, FDA will take immediate action against the company that processed the product,” Stevens says. “Initially, the agency will require the company to recall all affected product.”
In addition to mandating a recall of the affected product, FDA will also demand entrance into the production facility at issue, and begin sampling the environment extensively (taking hundreds of samples from the drains, floors, walls, production equipment, and finished products) to find the same strain of the sample testing positive at retail, Stevens continues. “In these circumstances, it is likely that FDA will identify additional positives, and any recall will broaden accordingly,” he says.
“Additionally, in the event that any product or environmental samples test positive, FDA will perform genetic DNA testing on the isolates collected from those samples, and compare the DNA fingerprints of those samples against the DNA fingerprints of the isolates collected from sick case patients over the last 20 years and uploaded into the PulseNet database,” Stevens relates. “If FDA discovers that the DNA fingerprint from any of those samples matches an illness (or illnesses) in the PulseNet database, FDA will immediately presume that all of the illnesses were caused by product that originated from that facility. This is the same scenario which unfolded in advance of the recent Blue Bell ice cream outbreak.”
Possible Criminal Investigations
Under the FDA’s new policies, if any human or pet food is contaminated and linked to a human illness, the agency will review the circumstances carefully to determine whether there is any basis for criminal liability against the company or its employees, Stevens says.
“As demonstrated in the recent Jensen Farms, Quality Egg, ConAgra, Blue Bell, Chipotle and other ongoing incidents, FDA has demonstrated its intent to initiate a criminal investigation against any food company executives or quality assurance managers involved in a case where a positive sample collected by FDA from their food facility or product is linked to a foodborne illness,” he emphasizes. “The FDA is using this power while, at the same time, exercising nearly limitless authority to access company records during the course of an inspection and investigation—without a warrant.”
The FDA’s new policy approach to criminal sanctions was recently announced in written statements issued by the U.S. Department of Justice.
“We have not yet witnessed the FDA bring criminal charges against any pet food companies or executives (as of April 2016, as we go to press),” Stevens points out. “But, given what the agency is doing to food companies generally, I expect that if it can be shown that a pet food was linked to a human illness, the agency will take the same approach.”
As a result, he counsels, it is critical for pet food manufacturers to begin sampling their production environment and making any necessary changes to control potential issues before FDA arrives to inspect the facility and begins sampling itself. “Preparing for your next FDA inspection today may save you from a massive recall tomorrow,” Stevens emphasizes.