FDA Issues Final Rule on Recordkeeping for Food and Cosmetics Containing Cattle Material, Etc.
The Food and Drug Administration (FDA) has issued a final rule, effective January 9, 2007, that will require that manufacturers and processors of human food and cosmetics that are manufactured from, processed with, or otherwise contain, material from cattle establish and maintain records sufficient to demonstrate that the human food or cosmetic is not manufactured from, processed with, or does not otherwise contain, prohibited cattle materials.
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(The regulations in this final rule replace the less detailed recordkeeping regulations contained in an earlier interim final rule. See ITT's Online Archives or 07/15/04 news, 04071520, for BP summary of the interim final rule on prohibited cattle materials. See ITT's Online Archives or 09/14/05 news, 05091420, for BP summary of the FDA's amendment of the interim final rule.)
Recordkeeping Requirements for Cattle Material in Human Food and Cosmetics
The FDA is adding the following recordkeeping requirements to 21 CFR 189.5(c) (Prohibited cattle materials) and 21 CFR 700.27(c) (Use of prohibited cattle materials in cosmetic products):
(1) Manufacturers and processors of a human food or cosmetic that is manufactured from, processed with, or otherwise contains, material from cattle must establish and maintain records sufficient to demonstrate that the food or cosmetic is not manufactured from, processed with, or does not otherwise contain, prohibited cattle materials.
(2) Records must be retained for 2 years after the date they were created.
(3) Records must be retained at the manufacturing or processing establishment or at a reasonably accessible location.
(4) The maintenance of electronic records is acceptable. Electronic records are considered to be reasonably accessible if they are accessible from an onsite location.
(5) Records required by this section and existing records relevant to compliance with this section must be available to FDA for inspection and copying.
(6) When filing entry with U.S. Customs and Border Protection (CBP), the importer of record of a human food or cosmetic manufactured from, processed with, or otherwise containing, cattle material must affirm that the food or cosmetic was manufactured from, processed with, or otherwise contains, cattle material.
The importer of record must also affirm that the food or cosmetic was manufactured in accordance with this section. If a human food or cosmetic is manufactured from, processed with, or otherwise contains, cattle material, then the importer of record must, if requested, provide within 5 days records sufficient to demonstrate that the food or cosmetic is not manufactured from, processed with, or does not otherwise contain, prohibited cattle material.
(7) Records established or maintained to satisfy the requirements of 21 CFR 189.5 or 21 CFR 700.27 that meet the definition of electronic records in Sec. 11.3(b)(6) of this chapter are exempt from the requirements of part 11 of this chapter. Records that satisfy the requirements of 21 CFR 189.5 or 21 CFR 700.27 but that are also required under other applicable statutory provisions or regulations remain subject to part 11 of this chapter.
(According to FDA sources, records kept for this final rule may be the same records kept for other FDA regulations, as long as both sets of record requirements are met.)
(See ITT's Online Archives or 07/15/04 news, 04071520, for BP summary of the proposed rule on recordkeeping requirements for cattle materials.)
FDA contact - Rebecca Buckner (301) 436-1486
FDA Final Rule, (D/N 2004N-0257, FR Pub 10/11/06) available at http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/pdf/E6-16830.pdf
BP Note
FDA sources state that the FDA is hoping that the affirmation for imports can be part of the electronic entry filing process, and expects to issue an update on affirmation filing options before the final rule's January 9, 2007 effective date.