FDA imposes record-keeping rules
10 December 2004
FDA imposes record-keeping rules
The following is excerpted from the 9 December 2004 edition of “The Journal of Commerce”.
WASHINGTON — The Food and Drug Administration has issued rules that require businesses in foreign or domestic food-supply chains to keep and maintain records of food shipments.
Unlike previous rules under the Bioterrorism Act of 2002, the record-keeping regulations apply to domestic shippers, carriers and intermediaries, as well as companies in international commerce.
Companies in the food-supply chain will have to keep records on where and from whom they have received shipments, where and to whom they were sent, plus quantities and descriptions of cargo. They must be able to retrieve the records on short notice, if the FDA or a law-enforcement agency requests them.
According to Newark, N.J., attorney Allen Molnar, the regulations are intended to help authorities track food shipments that may have been contaminated by biological agents.
"It's more palatable than people expected," Molnar said. "They have attempted to simplify the process and the way information is captured."
The compliance deadlines are being phased in until Dec. 9, 2006, depending on the size of the company. The largest companies - 500 employees or more - will have until Dec. 9, 2005. Retention requirements range from six months for perishable commodities, to two years for products with a longer shelf life.
"Even those companies that need to comply have a year to make sure their systems are in order," he said. Most companies are already collecting most of the data that the FDA requires. "For 75 percent of companies, the problem will be making sure they have record-retention and retrieval systems that are able to comply."
He recommended that company compliance officers review the new regulations. "If you take a couple of hours to analyze your trade documents, you'll find at each of the pieces are already captured," he said. For most companies, the important thing will be to have a safe place to store and retrieve their records."
The FDA's final rule is in the Dec. 9 Federal Register at http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo...