FDA and USDA Issue Rulemakings to Prevent Risk of BSE in Human Food (Including Dietary Supplements) and Cosmetics, Etc
The Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) have issued a press release announcing three actions being taken to further strengthen existing safeguards that protect consumers against the agent that causes Bovine Spongiform Encephalopathy (BSE), also known as mad cow disease.
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The three actions are as follows: (1) an FDA interim final rule that prohibits the use of certain cattle materials in FDA-regulated human food (including dietary supplements) and cosmetics; (2) an FDA proposed rule on recordkeeping requirements relating to the interim final rule; and (3) a joint USDA Food Safety and Inspection Service (FSIS), USDA Animal and Plant Health Inspection Service (APHIS), and FDA Advance Notice of Proposed Rulemaking (ANPR) seeking public comments on additional preventive actions that are being considered concerning BSE.
In addition, the FDA has issued a notice announcing the availability of a risk assessment regarding the potential for variant Creutzfeldt-Jakob Disease (vCJD) in humans from exposure to cosmetics containing cattle protein infected with the BSE agent.
This is Part I of a multi-part series of summaries on the three rulemakings and one notice. See future issues of ITT for additional summaries.
Certain Cattle Material in FDA-Regulated Human Food/Cosmetics Prohibited
The FDA's interim final rule, effective July 14, 2004, prohibits the use of certain cattle material, to address the potential risk of BSE, in FDA-regulated human food (including dietary supplements) and cosmetics. Prohibited cattle material includes specified risk materials (SRMs), 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.
(According to the FDA's interim final rule, SRMs 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 for both human food and cosmetics exclude 1) tallow that contains no more than 0.15% hexane-insoluble impurities and 2) tallow derivatives.
(The FDA notes that dietary supplements have been found to contain the following cattle materials: liver powder, brain, ovaries, eye tissue, mammary tissue, adrenal gland, hypothalamus, or substances derived from these tissues.
Regarding cosmetics, FDA states that they have been found to be made from a variety of cattle ingredients. Tallow derivatives, particularly fatty acids and glycerin, are the predominant bovine ingredient used by the cosmetic industry. Additionally, ingredients sometimes include albumin, brain extract, brain lipid, cholesterol, fibronectin, sphingolipids, collagen, keratin, and tallow.)
FDA Proposed Rule on Recordkeeping Requirements
According to the press release, in conjunction with the above-described interim final rule, FDA's proposed rule would require that manufacturers and processors of FDA-regulated human food and cosmetics maintain records showing that prohibited cattle materials are not used in their products.
Joint ANPR Seeks Comments on Additional BSE Measures, IRT Report
To allow interested parties and stakeholders the opportunity to comment on the additional regulatory and policy measures under consideration, the press release states that APHIS and FSIS, along with the FDA, developed the ANPR which includes several additional actions the federal government is considering regarding BSE.
According to the press release, the ANPR also provides the public a succinct report on the work of the international review team (IRT) convened to review the U.S. response to the single case of BSE in the U.S. (in a cow imported from Canada), along with a summary of the many actions already taken by USDA on BSE.
(See ITT's Online Archives or 01/13/04 news, 04011310, for BP summary of USDA's January 2004 interim final rules and notices on BSE protection measures.)
FDA and USDA press release (dated 07/09/04) available at http://www.fda.gov/bbs/topics/news/2004/NEW01084.html
FDA interim final rule (D/N 2004N-0081, FR Pub 07/14/04) available at http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/pdf/04-15881.pdf
FDA proposed rule (D/N 2004N-0257, FR Pub 07/14/04) available at http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/pdf/04-15880.pdf
Joint ANPR (D/N 04-047-1 (APHIS), D/N 04-021ANPR (FSIS), D/N 2004N-0264 (FDA); FR Pub 07/14/04) available at http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/pdf/04-15882.pdf
FDA notice on risk assessment (D/N 2004N-0291, FR Pub 07/14/04) available at http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/pdf/04-15979.pdf