The U.S. Food and Drug Administration (FDA) is requiring manufacturers and processors of human food and cosmetics that are manufactured from, processed with, or otherwise contain, material from cattle establish and maintain records sufficient to demonstrate that the human food or cosmetic is not manufactured from, processed with, or does not otherwise contain, prohibited cattle materials.

The aim of the new recordkeeping rule is to prevent human exposure to the causative agent of bovine spongiform encephalopathy (BSE). Experts believe that certain materials in cattle carcasses – mainly brain, spinal cord, and lymph tissue from cattle older than 20 months of age, deemed specified risk material (SRM) – contains high concentrations of the BSE causative agent.

“These recordkeeping requirements provide documentation for the provisions in FDA's interim final rule entitled ‘Use of Materials Derived From Cattle in Human Food and Cosmetics',” an FDA news release explained.

FDA is requiring recordkeeping because manufacturers and processors of human food and cosmetics need records to ensure that their products do not contain prohibited cattle materials, and records are necessary to help FDA ensure compliance with the requirements of the interim final rule.

In a news release, FDA said it believes that these recordkeeping requirements are necessary for manufacturers and processors to ensure that all cattle material they use is free from prohibited SRM cattle materials. Furthermore, these requirements are necessary for FDA to ensure compliance with the provisions of the interim final rule. There is currently no validated pre-mortem test to reliably detect the presence of the BSE agent or the presence of prohibited SRM in human food and cosmetics.

Once the SRM is removed from the source animal, it may not be possible to determine the age of the animal from which the material came without records and, therefore, whether the material is a SRM. In addition, without records, it may not be possible to determine whether a product contains material from cattle that were not inspected and passed for human consumption. Also, a product might contain beef without its presence being evident from the appearance of the product, FDA said.