FSIS and FDA Issue Interim Final Rules Allowing Use of Most Beef Small Intestine in Food and Cosmetics
The Food and Safety Inspection Service (FSIS) and the Food and Drug Administration (FDA) are amending, effective October 7, 2005, the interim final rules issued in 2004 on the use of materials derived from cattle in human food and/or cosmetics, in order to provide for the use of most parts of beef small intestine.
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Specifically, FSIS is amending its January 2004 interim final rule, "Prohibition of the Use of Specified Risk Materials for Human Food and Requirements for the Disposition of Non-Ambulatory Cattle," in order to permit beef small intestine, excluding the distal ileum, to be used for human food, provided that such product is derived from cattle that were slaughtered in an official establishment in the U.S. or in a certified foreign establishment from a foreign country that is eligible to export beef products to the U.S.
The FDA is also amending its July 2004 interim final rule, "Use of Materials Derived From Cattle in Human Food and Cosmetics" which had designated certain materials from cattle, including the entire small intestine, as "prohibited cattle materials" and also banned the use of such materials in human food, including dietary supplements, and in cosmetics. The FDA is making certain amendments in order to allow the use of the beef small intestine, with the exception of the distal ileum, in human food and cosmetics.
As an additional amendment, the FDA is also clarifying that milk and milk products, hide and hide-derived products, and tallow derivatives are not prohibited cattle materials. The FDA is also amending its regulations to cite a less costly method for determining insoluble impurities in tallow.
FDA, FSIS Find Distal Ileum Can Be Effectively Removed From Small Intestine
FSIS states that it has determined that the removal of the distal ileum in accordance with these amendments will provide the same level of protection from human exposure to the bovine spongiform encephalopathy (BSE) agent as does the exclusion of the entire small intestine from the human food supply.
The FDA explains that it is taking this action in response to comments received on its interim final rule that persuaded the agency that the distal ileum, one of the three portions of the small intestine, could be consistently and effectively removed from the small intestine, such that the remainder of the intestine, formerly a prohibited cattle material, could be used for human food or cosmetics. The FDA also indicates that the amended interim final rule provides the same level of protection against the agent that causes BSE as the original provisions.
(See ITT's Online Archives or 07/15/04 news, 04071520, for BP summary of July 2004 FDA interim final rule. See ITT's Online Archives or 01/13/04 news, 04011310, for BP summary of January 2004 FSIS interim final rule).
- comments to both agencies on the amendments to the interim final rules due by 11/07/05
FSIS Contact - Daniel Engeljohn (202) 205-0495
FDA Contact - Rebecca Buckner (301) 436-1486
FSIS interim final rule (D/N 03-025IFA, FR Pub 09/07/05) available at http://a257.g.akamaitech.net/7/257/2422/01jan20051800/edocket.access.gpo.gov/2005/pdf/05-17683.pdf
FDA interim final rule (D/N 2004N-0081, FR Pub 09/07/05) available at http://a257.g.akamaitech.net/7/257/2422/01jan20051800/edocket.access.gpo.gov/2005/pdf/05-17693.pdf