Record keeping for U.S. food shippers takes effect in 12 months

Record keeping for U.S. food shippers takes effect in 12 months The U.S. Food and Drug Administration has issued new record keeping rules for companies that handle food in any capacity.
   The rule implements section 306 of the 2002 Bioterrorism Act, which directs the Health and Human Services secretary to issue regulations regarding persons who manufacture, process, pack, transport, distribute, receive, hold or import food to establish and maintain records. These records identify the immediate previous source of all food received, as well as, the immediate subsequent recipient of all food released.
   “These records will be crucial for FDA to deal effectively with food-related emergencies, such as deliberate contamination of food by terrorists,” said Lester M. Crawford, acting FDA commissioner, in a Dec. 6 statement. “The ability to trace back will enable us to get to the source of contamination.
   “The records also enable FDA to trace forward to remove adulterated food that poses a significant health threat in the food supply,” he said.
   The record retention period for human foods ranges from six months to two years, depending on the shelf life of the food. Records for animal food, including pet food, must be retained for one year. The maximum record retention requirement for transporters of all types of food is one year.
   Records must be retained at the location where the activities covered in the records occurred or at a reasonable accessible location, the FDA said. To minimize the burden on food companies affected by the final rule, companies may keep required information in any format, paper or electronic. All business covered by this rule must comply within 12 months from the date the rule is published in the Federal Register.
   “When FDA has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, any records or other information to which FDA has access must be available for inspection and copying as soon as possible, not to exceed 24 hours from time of receipt of the official request,” the FDA said.
   The Bioterrorism Act allows FDA to take civil and criminal action in a federal court for any person who fails to comply with the record keeping rule.
   The FDA has issued three other final rules under the Bioterrorism Act, which are in effect. They include:
   * Registration of overseas and domestic food facilities.
   * Prior notice for food imports entering the United States.
   * Administrative detention for high-risk food shipments.
   FDA will hold seven public meetings in January and February 2005 to explain the requirements of its record keeping rule. “Registration is on a first-come, first served basis,” the agency said.
   To register for the public meetings or to view information on all four food supply protections, access online: https://www.fda.gov/oc/bioterrorism/bioact.html.