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HHS/FDA

RIN: 0910-AF47

Publication ID: Spring 2007

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 and 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 (Amendments)	09/07/2005	70 FR 53063
Interim Final Rule (Amendments) Comment Period End	11/07/2005
Final Action	04/00/2008

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