This final regulation implements section 306 of the Bioterrorism Act, which requires anybody and everybody who has something to do with food production at any point in the chain - including those in the supplement industry - to establish and maintain records.
"These records will be crucial for the FDA to deal effectively with food-related emergencies, such as deliberate contamination of food by terrorists," said Dr. Lester Crawford, the acting FDA commissioner.
He added: "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."
The record retention period for human foods ranges from six months to two years depending on the shelf life of the food. All companies - excluding small businesses - have until December 2005 to comply.
Those businesses with 11-499 full-time equivalent employees must comply within 18 months, while those with 10 employees or less have up to two years to put these measures in place.
This is the fourth and final regulation issued by the FDA aimed at increasing the safety and security of the US food supply. The three already in action cover the registration of foreign and domestic food facilities; the prior notice of food shipments imported or offered for import into the US; and administrative detention, so that food products that might pose a threat of serious adverse health consequences or death may be detained.
FDA will be holding four public meetings in January and February 2005 to explain the requirements of the final rule and answer questions.
Richard Jarman, the vice president of food and environmental policy for the NFPA, thought that "industry communication and education" would now be vital to make sure that these regulations were implemented and understood in harmony with any recordkeeping requirements already in place in different food companies.