d Drug Administration held its first public meeting last week on its proposed rule on intentional adulteration under the Food Safety Modernization Act (FSMA).“We see this, in many ways, while being different in terms of where the hazards come from, in line with the basic principles that underlie FSMA,” said Michael Taylor, FDA’s deputy commissioner for foods and veterinary medicine, at the Feb. 20 meeting held in College Park, MD.
“Here, we’re not talking about hazards that we know a lot about …. We’re talking about purposeful human behavior that has a hostile motive and has every motive to be surreptitious and not be something that you can really study and anticipate in the same way. We fully appreciate the challenge that that presents.”
The rule is the sixth proposed FSMA rule and will require domestic and foreign food facilities to address hazards that may be intentionally introduced by acts of terrorism.
Don Kraemer, a senior advisor with FDA’s Center for Food Safety and Applied Nutrition (CFSAN), said that the agency is particularly interested in hearing comments regarding how the proposed rule could be modified to better focus it, whether it would be feasible and consistent with the statutory charge to require measures to protect against intentional adulteration only in the event of a “credible threat,” and what the appropriate level of public health protection is with respect to intentional adulteration.
The rule focuses on acts intended to cause massive harm to public health rather than economically motivated adulteration and acts of disgruntled employees, consumers, or competitors. Several presenters at the meeting explained that the focus is on a “sophisticated insider” – someone with legitimate access to the food system.
CFSAN economist Richard Bruns noted that the intentional adulteration rule does not fit into a typical cost-benefit analysis because “in most years, the economic benefit of this rule will be zero.” FDA doesn’t anticipate that there will be a massive attack on the food system every year.
But, Bruns said, the benefits from it will be larger than the costs if the rule prevents a catastrophic attack every 350 years. The projected costs of complying with the rule are $180 million for domestic firms and $370 million in total annualized costs, but the benefit is saving $130 billion per prevented catastrophic attack.
Questions and comments raised by the public included requests for information on how the rule will be enforced within foreign plants, clarification of certain language, whether food defense plans would be subject to Freedom of Information Act (FOIA) requests, and why economically motivated adulteration and acts of disgruntled employees, consumers, or competitors were not also addressed by the rule.
Upcoming FDA meetings in Chicago, IL, on Feb. 27 and in Anaheim, CA, on March 13 will also address the intentional adulteration rule, as well as the sanitary transportation rule.
