Record keeping rule to come into effect
be required to keep records to show that their products are not
manufactured using prohibited animal parts.
The Food and Drug Administration (FDA) this week issued a final rule making notice on therequirement, which will take effect from January 9, 2007. The records must be made available to FDA forinspection and copying within five days of a request.
The rule is another traceability requirement, on top of regulations on trace-back or trace-forwardactivities under the Bioterrorism Act. Traceability records allow manufacturers and regulators totrack food from the source to the consumer. This makes it easier to pinpoint problems when a foodsafety incident occurs, and make recalls if necessary.
" We believe that records sufficient to demonstrate the absence of prohibited cattle materials in human food and cosmetics are criticalfor manufacturers, processors, and FDA to ensure compliance with the ban on prohibited cattlematerials," the agency stated.
The rule requires that manufacturers and processors of human food and cosmetics maintain traceabilityrecords for products that are "manufactured from, processed with, or otherwise contain, material fromcattle.". The records must have sufficient information to demonstrate that the human food or cosmetic is not drived from cattle
The recordkeeping provisions of the rule apply to food and cosmetics, including food additives, dietarysupplements, and dietary ingredients.
The FDA has also clarified that manufacturers and processors of certain cattle-derived products,such as tallow derivatives, milk and milk products, are exempt from the recordkeeping requirements.
In relation to the type of records that must be kept, the FDA recommends that manufacturers and processorsupdate the information at least annually, from suppliers of cattle materials and of products.Manufacturers and processors should also maintain a record of the source, type, volume, and date of receipt for the cattlematerial or product manufactured from, processed with, or otherwise containing, cattle material.
The FDA plans to publish guidance describing in detail the types of records that would complywith the rule.
The rule was originally proposed in a FDA notice of July 14, 2004 in a bid to ensure high riskanimal parts, such as those specified as banned due to bovine spongiform encephalopathy (BSE), donot end up in foods or cosmetics.
The ban was made in response to the December 2003 discovery in Washington state of BSE in an adultcow imported from Canada. The FDA subsequently made a rule requiring that specified risk materials (SRMs) not be used for FDA-regulated human food andcosmetics.
SRMs include the small intestine of all cattle, tissue from nonambulatory disabled cattle, tissue from cattle not inspectedand passed for human consumption, and mechanically separated beef. SRMs also include the brain, skull, eyes, trigeminal ganglia, spinal cord,vertebral column, and dorsal root ganglia from cattle 30 months and older.
In June 2005, the US agriculture department confirmed the second case in the US of BSE in a cow born inTexas.
