United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2005_register executive 2010-09-23 article Rules and Regulations D09002ee1c810d538 D09002ee1c810d5b8 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is amending the interim final rule on use of materials derived from cattle in human food and cosmetics published in the Federal Register of July 14, 2004. In the July 14, 2004, interim final rule, FDA designated certain materials from cattle, including the entire small intestine, as "prohibited cattle materials" and banned the use of such materials in human food, including dietary supplements, and in cosmetics. FDA is taking this action in response to comments received on the interim final rule. Information was provided in comments that persuaded the agency that the distal ileum, one of three portions of the small intestine, could be consistently and effectively removed from the small intestine, such that the remainder of the small intestine, formerly a prohibited cattle material, could be used for human food or cosmetics. We (FDA) are also clarifying that milk and milk products, hide and hide-derived products, and tallow derivatives are not prohibited cattle materials. Comments also led the agency to reconsider the method cited in the interim final rule for determining insoluble impurities in tallow and to cite instead a method that is less costly to use and requires less specialized equipment. FDA issued the interim final rule to minimize human exposure to materials that scientific studies have demonstrated are highly likely to contain the bovine spongiform encephalopathy (BSE) agent in cattle infected with the disease. FDA believes that the amended provisions of the interim final rule provide the same level of protection from human exposure to the agent that causes BSE as the original provisions. 70 FR 53063 https://www.govinfo.gov/app/details/FR-2005-09-07/05-17693 05-17693 fr07se05-7 RIN 0910-AF47 4160-01-S Docket No. 2004N-0081 https://www.govinfo.gov/app/details/FR-2005-09-07/05-17693 https://www.govinfo.gov/content/pkg/FR-2005-09-07/html/05-17693.htm https://www.govinfo.gov/content/pkg/FR-2005-09-07/pdf/05-17693.pdf 7 p. 53063 53069 70 FR 53063 Title 21 Part 189 21 CFR Part 189 Title 21 Part 700 21 CFR Part 700 RIN 0910-AF47 Use of Materials Derived From Cattle in Human Food and Cosmetics; Federal Register Vol. 70, Issue RULE 05-17693 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2005-10-07 2005-10-07 Docket No. 2004N-0081 4160-01-S 05-17693 Interim final rule and request for comments.

The Food and Drug Administration (FDA) is amending the interim final rule on use of materials derived from cattle in human food and cosmetics published in the Federal Register of July 14, 2004. In the July 14, 2004, interim final rule, FDA designated certain materials from cattle, including the entire small intestine, as "prohibited cattle materials" and banned the use of such materials in human food, including dietary supplements, and in cosmetics. FDA is taking this action in response to comments received on the interim final rule. Information was provided in comments that persuaded the agency that the distal ileum, one of three portions of the small intestine, could be consistently and effectively removed from the small intestine, such that the remainder of the small intestine, formerly a prohibited cattle material, could be used for human food or cosmetics. We (FDA) are also clarifying that milk and milk products, hide and hide-derived products, and tallow derivatives are not prohibited cattle materials. Comments also led the agency to reconsider the method cited in the interim final rule for determining insoluble impurities in tallow and to cite instead a method that is less costly to use and requires less specialized equipment. FDA issued the interim final rule to minimize human exposure to materials that scientific studies have demonstrated are highly likely to contain the bovine spongiform encephalopathy (BSE) agent in cattle infected with the disease. FDA believes that the amended provisions of the interim final rule provide the same level of protection from human exposure to the agent that causes BSE as the original provisions.

The amendments to the interim final rule are effective October 7, 2005. Submit written or electronic comments on the amendments to the interim final rule by November 7, 2005. The Director of the Office of the Federal Register approves the incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of certain publications in 21 CFR 189.5 and 700.27 as of October 7, 2005. Rebecca Buckner, Center for Food Safety and Applied Nutrition (HFS-306), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1486. Food and cosmetics: Cattle materials; prohibited use, fdadockets@oc.fda.gov http://europa.eu.int/comm/food/fs/bse/scientific_advice08_en.html http://www.aocs.org http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html http://www.fda.gov/dockets/ecomments http://www.fda.gov/ohrms/dockets/default.htm http://www.regulations.gov Vol. 70, no. 172 Office of the Federal Register, National Archives and Records Administration 2005-09-07 continuing daily deposited born digital 262 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2005-09-07 P0b002ee18098ad06 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr07se05 https://www.govinfo.gov/app/details/FR-2005-09-07 https://www.govinfo.gov/content/pkg/FR-2005-09-07/pdf/FR-2005-09-07.pdf https://www.govinfo.gov/content/pkg/FR-2005-09-07/xml/FR-2005-09-07.xml fdlp 53043 53293 DGPO 2010-09-23 2024-06-06 FR-2005-09-07 machine generated eng FR FR-2005-09-07 70 172