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HHS/FDA | RIN: 0910-AF47 | Publication ID: Spring 2009 |
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. 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. On April 17, 2008, FDA amended the IFR so that FDA may designate a country as not subject to certain BSE-related restrictions relating to prohibited cattle materials applicable to human food and cosmetics. Comments submitted in response to the July 14, 2004 IFR that were not addressed in the September 7, 2005 and April 17, 2008 amendments will be addressed in the final rule. The final rule also will respond to comments submitted following the September 7, 2005 and April 17, 2008 amendments. | |
Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
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 |
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Timetable:
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Regulatory Flexibility Analysis Required: Yes | Government Levels Affected: None |
Small Entities Affected: Businesses | Federalism: No |
Included in the Regulatory Plan: No | |
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. | |
RIN Data Printed in the FR: Yes | |
Agency Contact: Charli Long Supervisory Chemist Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine, 7500 Standish Place, MPN-2, HFV-150, Rockville, MD 20855 Phone:240 402-0850 Email: charli.long-medrano@fda.hhs.gov |