According to news media reports, the focus of the hearing was mainly on the issues surrounding risk assessment and the concentration of FDA attention on "high-risk" products. But in zeroing in on the "high-risk" issue, Senators have apparently overlooked an even greater flaw in this Plan - the so-called "mandatory recall" provision.
For several years, Senator Tom Harkin (now Chairman of the Senate Agriculture Committee) has sponsored legislation to provide the FDA and USDA with authority to mandate recalls of foods that present a hazard to human health. Each time, the Bush Administration claimed that it had no need of such authority; the voluntary recall system was working. Now, the Administration appears to have had a change of heart. Or has it?
The mandatory recall authority proposed in the Plan reads as follows:
"This authority would be limited to foods that the Secretary has reason to believe are adulterated and present a threat of serious adverse health consequences or death. It would be imposed only if a firm refuses or unduly delays conducting a voluntary recall. An order to recall food could only be issued by the HHS Secretary, Deputy Secretary, or Commissioner of Food and Drugs, and would be accompanied by appropriate due process rights."
There are several major flaws in this proposal. The most glaring is the total exclusion of mandatory recall authority for USDA, the federal government department that regulates all meat, poultry and processed egg products in the United States (including, for example, pepperoni-topped pizza). Another loophole is the lack of definition of the terms "threat of serious adverse health consequences", "unduly delays" and "due process rights". Are vomiting or diarrhea "serious adverse health consequences", or would the new authority only cover life-threatening situations such as botulism or hemolytic uremic syndrome (HUS)? How long is an undue delay? Who decides? And what constitutes "due process rights"? Will FDA need to go to court each time it needs to exercise its mandatory recall authority?
Canada has had mandatory recall authority on its books for ten years under the Canada Food Inspection Agency Act. The law, which covers all foods, simply states:
"19. (1) Where the Minister believes on reasonable grounds that a product regulated under an Act or provision that the Agency enforces or administers by virtue of section 11 poses a risk to public, animal or plant health, the Minister may, by notice served on any person selling, marketing or distributing the product, order that the product be recalled or sent to a place designated by the Minister.”
There is no requirement, under the Canadian law, for the Canada Food Inspection Agency to demonstrate that a company has "unduly delayed" implementing a recall. The authority is the Agency's to use as needed to ensure prompt action and to protect public health.
President Theodore Roosevelt once advised that we should "Walk softly and carry a big stick." That advice should be heeded by this Administration in its dealings with the food industry, both domestic and foreign. Unfortunately, the "mandatory recall" proposal described in the Food Protection Plan will have the FDA walking on eggshells with nothing more than a small twig in hand with which to enforce its mandate.