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HHS/FDA RIN: 0910-AF47 Publication ID: Fall 2006 
Title: Use of Materials Derived From Cattle in Human Food and Cosmetics 
Abstract: On July 14, 2004, FDA issued an interim final rule (IFR), effective immediately, to prohibit the use of certain cattle material, to address the potential risk of bovine spongiform encephalopathy (BSE), in human food, including dietary supplements, and cosmetics. Prohibited cattle materials under the IFR include specified risk materials, small intestine of all cattle, material from nonambulatory disabled cattle, material from cattle not inspected and passed for human consumption, and mechanically separated (MS) (Beef). Specified risk materials are the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months and older; and the tonsils and distal ileum of the small intestine of all cattle. Prohibited cattle materials do not include tallow that contains no more than 0.15 percent hexane-insoluble impurities and tallow derivatives. This action minimizes human exposure to materials that scientific studies have demonstrated are highly likely to contain the BSE agent in cattle infected with the disease. Scientists believe that the human disease variant Creutzfeldt-Jakob disease (vCJD) is likely caused by the consumption of products contaminated with the agent that causes BSE. After reviewing comments received to the interim final rule, FDA intends to issue a final rule. On September 7, 2005, FDA amended the IFR to permit the use of small intestine in human food and cosmetics if it is effectively removed from the distal ileum. The amendment also clarified that milk and milk products, hides, and tallow derivatives are not prohibited for use in human food and cosmetics. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 189.5; 21 CFR 700.27 
Legal Authority: 21 USC 342; 21 USC 361; 21 USC 371 
Legal Deadline:  None
Timetable:
Action Date FR Cite
Interim Final Rule  07/14/2004  69 FR 42256 
Interim Final Rule Comment Period End  10/12/2004   
Interim Final Rule (Ammendments)  09/07/2005  70 FR 53063 
Final Action  To Be Determined   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact:
Morris E. Potter
Lead Scientist for Epidemiology
Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition, HFS-032, 60 Eighth Street NE.,
Atlanta, GA 30309
Phone:404 253-1225
Fax:404 253-1218
Email: morris.potter@fda.hhs.gov

 
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