WASHINGTON -- The Food and Drug Administration has published the last two of four food-safety rules that have the food industry suffering from a collective case of heartburn, with complaints the new mandatory reporting requirements will potentially disrupt the food-distribution system.
The publication of the regulations in the Federal Register opens a 60-day comment period. After that, the agency will complete the final draft of the rules, and put them in effect Dec. 12.
Specifically, the first proposed regulation requires food companies to keep records identifying the source from which they received the food, and the subsequent recipient of the products. The second gives the FDA new authority to detain any shipment of food, based on credible evidence that the food poses a threat to health or safety. The detention rule contains a provision for expediency when perishable foods are involved, and gives companies up to two days to appeal the action, officials noted.
"We can't just be detaining them and letting them spoil without good reason," said Lester Crawford, deputy commissioner of the FDA during a briefing last week for the media. "We have to keep the product moving. We're not under the law supposed to be an agent for causing spoilage of these foods."
Nevertheless, the agency is prepared to enforce the rules, he added. With respect to the recordkeeping rule, officials will send warning letters to companies found, through audits, not to be in compliance, and follow up with inquiries to make sure corrective steps have been taken.
Officials estimated implementing the detention rule could cost as much as $38 million, while the recordkeeping regulation may run as high as $383 million on average per year. When other regulations were put into place, Crawford noted initial costs were high, but over time dropped significantly.
The rules complete the package of regulations contained in the Bioterrorism Act of 2002, which was designed to strengthen the government's power to protect the nation's food supply from acts of terrorism. The other two rules, concerning the registration of food facilities and prior notice of imported foods, were published in January.
