FDA and USDA 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 announced three rulemakings 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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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 III, the final part of a series of summaries on the three rulemakings and one notice. Part III highlights (1) the FDA's proposed rule on recordkeeping requirements, (2) the joint Advance Notice of Proposed Rulemaking (ANPR) issued by the FDA and the USDA's Food Safety and Inspection Service (FSIS) and Animal and Plant Health Inspection Service (APHIS) on additional BSE measures under consideration, and (3) the FDA's risk assessment regarding vCJD in cosmetics.
FDA's Proposed Rule on Recordkeeping Requirements
The FDA's proposed rule would provide recordkeeping requirements for human food (in 21 CFR 189.5(c)) and for cosmetic products (in 21 CFR 700.27(c)) which are substantially similar to one another, as follows (partial list):
Sufficient records would have to be established and maintained. Manufacturers and processors of FDA-regulated human food or an FDA-regulated cosmetic that is manufactured from, processed with, or otherwise contains, material from cattle would have to establish and maintain records sufficient to demonstrate that the food is not manufactured from, processed with, or does not otherwise contain, prohibited cattle materials.
(For example, the proposed rule's preamble states that a manufacturer or processor of FDA-regulated human food or cosmetics containing cattle material could have, among other types of records, a signed and dated affirmation (with contact information) by the slaughter establishment that cattle material supplied by that establishment in a particular shipment does not contain prohibited cattle materials.)
Importers would have to electronically affirm compliance with above recordkeeping requirement, etc. Importers would have to electronically affirm their compliance at the time of entry into the U.S. with the above requirement to establish and maintain records, and would have to, if requested, provide the required records within a reasonable time.
2 year retention period; availability. According to the proposed rule, records would have to be retained at the manufacturing or processing establishment or at a reasonably accessible location for two years after the date the records were created. In addition, the required records would have to be available to FDA for inspection and copying.
Joint ANPR Seeks Comments on Additional Measures, Etc.
FDA states that the purpose of the joint ANPR is to inform the public about the recommendations of an international review team (IRT), convened by USDA in response to a December 2003 detection of BSE in Washington state, and to seek comment on additional measures under consideration based on the IRT's recommendations, and other considerations.
The IRT made several policy recommendations designed to further reduce the risk of cattle being exposed to BSE, which include several changes that the federal government had already embarked upon. Among other federal government polices discussed in the ANPR, the FDA seeks comments on a possible proposed rule to remove specified risk materials (SRMs) from all animal feed, and APHIS provides details on the development and implementation of a national animal identification system (NAIS).
(See ITT's Online Archives or 07/20/04 news, 04072099 6, for BP summary of APHIS' announcement of a August 4-5, 2004 meeting to discuss NAIS.)
Risk Assessment on vCJD in Cosmetics
According to FDA, there is some risk of occurrence of vCJD in humans from the use of cattle-derived protein in cosmetics.
FDA states that the risk of BSE from cosmetics may be reduced through the control of exposure. The assessment states that aside from the derivation processes used on tallow, the effectiveness of cosmetic manufacturing processes for inactivating BSE prions (proteins) is unknown. According to the assessment, the surest way to prevent transmission of the BSE-prion through cosmetics is to avoid the use of high-risk cattle-derived protein in the manufacture of cosmetics.
(See ITT's Online Archives or 07/15/04 and 07/16/04 news, 04071520 and 04071615, for Parts I and II of this series.)
- written comments on the FDA's proposed rule are due by August 13, 2004
- written comments on the joint ANPR are due to FDA on or before August 13, 2004, and to APHIS and FSIS on or before September 13, 2004
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
FDA Risk assessment (dated 07/14/04) available at http://www.cfsan.fda.gov/comm/bse-ra.html