The FDA’s release in December of a proposed rule that would require the nation’s largest food businesses to take steps to prevent intentional food adulteration met with little surprise, though some in the food industry feel the guideline is both too specific and too broad.
The so-called “Focused Mitigation Strategies to Protect Food Against Intentional Adulteration,” part of the Food Safety Modernization Act, is a preventative measure for which the FDA is seeking public comment until March 31. It is the first time the agency has proposed a regulatory measure to tackle the problem. The FDA characterized the rule as building on previous efforts to protect the food supply since the Sept. 11, 2001 terrorist attacks and the subsequent passage of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.
In the proposed rule, the FDA identified four key vulnerable activities within the food system: Bulk liquid receiving and loading, liquid storage and handling, secondary ingredient handling, and mixing and similar activities.
Jennifer McEntire, PhD, vice president and chief science officer of The Acheson Group, a strategic consulting firm for food and beverage companies, characterizes the rule as being both too broad and too specific. For example, the FDA defined intentional adulteration very specifically, including terrorism but not economic motivation, which the FDA will look at in a later version.
“Economic motivation is a different type of issue. I’m not convinced it belongs with preventative controls,” says Dr. McEntire. Economics involves companies using lesser ingredients to gain financially, such as the melamine added to infant formula in China in 2008. She adds that the proposed rule doesn’t address the worst types of contaminants, such as agents that can survive the thermal process.
“The FDA was in an unenviable position to have to write this rule,” she says. “It’s a difficult topic to address, and I think they’ll get many heated comments.”
The FDA emphasized that such food tainting is unlikely, and said it was unaware of an event where the food supply was adulterated with the intent of inflicting massive public harm. “The goal is to protect the food supply from those who may attempt to cause large-scale public health harm,” Michael R. Taylor, the FDA’s deputy commissioner for foods and veterinary medicine, said in a statement when the draft rule was released.
However, Dr. McEntire and others point to an earlier tainting event that didn’t qualify as large-enough scale, namely the 1984 bioterror attack in Oregon by a cult that sprayed Salmonella on salad bars at 10 restaurants in an effort to incapacitate voters.
FDA estimates the benefit of preventing a catastrophic food supply terrorist attack at about $130 billion.
The agency estimates the cost of the proposed rule to domestic and foreign firms is $260 million to $470 million annualized over 10 years, with higher first-year costs. The average annualized cost per firm is about $37,000, with initial costs of $70,000.
“This will cost people time and money but it is something they should do. You want to protect your brand and company, and a little protection goes a long way,” says Virginia Deibel, PhD, director of microbiology at Covance, where she oversees nutritional chemistry and food safety services.
She says food producers have already or should be addressing this.
“It’s no more of a burden than HAACP,” says Dr. Deibel, of adding the safety measures. “When you identify process points in your flow diagram that contain mixing or receiving, it would be one more step for users.”
The rule covers both domestic and foreign facilities that manufacture, process, pack, or hold food and are required to register as a food facility under section 415 of the FD&C Act. It doesn’t apply to farms or food for animals.
The FDA is proposing staggered implementation dates ranging up to three years after publication of the final rule based on business size. For example, very small businesses with less than $10 million in annual sales would have to comply within three years after the final rule is published.