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Department of Health and Human Services Food and Drug Administration Friday, April 25, 2008 Part VI Department of Health and Human Services Food and Drug Administration 21 CFR Part 589 Substances Prohibited From Use in Animal Food or Feed; Final Rule VerDate Aug<31>2005 20:09 Apr 24, 2008 Jkt 214001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\25APR2.SGM 25APR2 sroberts on PROD1PC70 with RULES 22720 Federal Register / Vol. 73, No. 81 / Friday, April 25, 2008 / Rules and Regulations DEPARTMENT OF HEALTH AND B. Requirements if it occurs at all. Scientists believe that HUMAN SERVICES C. Recordkeeping and Access the primary route of transmission Requirements requires that cattle ingest feed that has Food and Drug Administration D. Changes to § 589.2000—Animal Proteins been contaminated with a sufficient Prohibited in Ruminant Feed IV. Analysis of Economic Impacts amount of meat and bone meal (MBM) 21 CFR Part 589 A. Summary of Final Regulatory Impact from an infected animal. This route of [Docket No. 2002N–0273] (Formerly Docket Analysis transmission can be prevented by No. 02N–0273) B. Cost Effectiveness of Final Rule and excluding potentially contaminated Alternatives materials from ruminant feed. RIN 0910–AF46 C. Need for Regulation Scientific and epidemiological studies D. Benefits have linked variant Creutzfeldt-Jakob Substances Prohibited From Use in E. Costs disease (vCJD) in humans to exposure to Animal Food or Feed F. Government Costs the BSE agent, most likely through G. Sensitivity Analysis human consumption of beef products AGENCY: Food and Drug Administration, H. Regulatory Flexibility Analysis HHS. V. The Small Business Regulatory contaminated with the agent. As of February 2007, 165 probable and ACTION: Final rule. Enforcement Fairness Act of 1996 (SBREFA) confirmed cases of vCJD have been SUMMARY: The Food and Drug VI. Paperwork Reduction Act of 1995 reported in the United Kingdom. It is Administration (FDA) is amending the VII. Environmental Impact believed that in the United States, agency’s regulations to prohibit the use VIII. Federalism where measures to prevent the of certain cattle origin materials in the IX. References introduction and spread of BSE have food or feed of all animals. These I. Introduction been in place for some time, there is far materials include the following: The less potential for human exposure to the BSE is a progressive and fatal entire carcass of bovine spongiform BSE agent. The Centers for Disease neurological disorder of cattle that encephalopathy (BSE)-positive cattle; Control and Prevention (CDC) leads a results from an unconventional the brains and spinal cords from cattle surveillance system for vCJD in the transmissible agent. BSE belongs to the 30 months of age and older; the entire United States. As of November 2006, family of diseases known as carcass of cattle not inspected and CDC had detected two vCJD cases transmissible spongiform passed for human consumption that are involving United States residents who encephalopathies (TSEs). All TSEs 30 months of age or older from which were born and raised in the United affect the central nervous system of brains and spinal cords were not Kingdom. A third case was confirmed infected animals. However, the removed; tallow that is derived from by CDC in November 2006 and involved distribution of infectivity in the body of BSE-positive cattle; tallow that is a United States resident living in the animal and mode of transmission derived from other materials prohibited Virginia who was born and raised in differ according to the species and TSE by this rule that contains more than 0.15 Saudi Arabia and had lived in the agent. In addition to BSE, TSEs include, percent insoluble impurities; and United States since 2005. This among other diseases, scrapie in sheep mechanically separated beef that is individual did not live in Europe at any and goats, chronic wasting disease in derived from the materials prohibited by time, and CDC has determined that this deer and elk, and Creutzfeldt-Jakob this rule. These measures will further person was most likely infected from disease in humans. contaminated cattle products consumed strengthen existing safeguards against The agent that causes BSE has yet to BSE. as a child when living in Saudi Arabia. be fully characterized. The theory that is On December 23, 2003, the U.S. DATES: This final rule is effective April most accepted in the international Department of Agriculture (USDA) 27, 2009. The Director of the Office of scientific community is that the agent is diagnosed BSE in an adult cow in the the Federal Register approves the an abnormal form of a normal protein United States that had been imported incorporation by reference in known as cellular prion protein. The from Canada. Since then, USDA has accordance with 5 U.S.C. 552(a) and 1 BSE agent does not evoke a traditional confirmed two other cases of BSE in CFR part 51 of a certain publication in immune response or inflammatory adult cows in the United States. One new 21 CFR 589.2001 effective April 27, reaction in host animals. BSE is cow, which was diagnosed on June 24, 2009. confirmed by post-mortem microscopic 2005, was born and raised in Texas. The FOR FURTHER INFORMATION CONTACT: Burt examination of an animal’s brain tissue other cow, which was diagnosed on Pritchett, Center for Veterinary or by detection of the abnormal form of March 15, 2006, had been on a farm in Medicine (HFV–222), Food and Drug the prion protein in an animal’s brain Alabama for less than a year. The Texas Administration, 7519 Standish Pl., tissues. The pathogenic form of the cow was 12 years old and the Alabama Rockville, MD 20855, 240–453–6860, e- protein is both less soluble and more cow was determined to be more than 10 mail: [email protected]. resistant to degradation than the normal years old. Therefore, both cows were SUPPLEMENTARY INFORMATION: form. The BSE agent is resistant to heat born before FDA’s 1997 ruminant feed and to normal sterilization processes. rule (62 FR 30936, June 5, 1997) was in Table of Contents BSE is not a contagious disease, and place. I. Introduction therefore is not spread through casual Under USDA’s enhanced BSE II. Comments on the Proposed Rule contact between animals. The surveillance program, 787,711 cattle A. General Comments possibility of maternal transmission were tested between June 1, 2004, and B. Comments on Proposed New (i.e., from a bovine dam directly to her September 20, 2006. As previously § 589.2001—Cattle Materials Prohibited offspring) was suggested by a 1997 noted, only two animals tested positive in Animal Food or Feed C. Comments on Proposed Amendments to study conducted in the United for BSE, one in Texas and one in § 589.2000—Animal Proteins Prohibited Kingdom. However, subsequent studies Alabama. In September 2006, USDA in Ruminant Feed have shown that it is unlikely that transitioned to an ongoing surveillance III. Description of the Final Rule maternal transmission of BSE occurs at plan under which approximately 40,000 A. Definitions any epidemiologically significant level, cattle are tested per year. VerDate Aug<31>2005 20:09 Apr 24, 2008 Jkt 214001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\FR\FM\25APR2.SGM 25APR2 sroberts on PROD1PC70 with RULES Federal Register / Vol. 73, No. 81 / Friday, April 25, 2008 / Rules and Regulations 22721 In the October 6, 2005, issue of the eliminated by the 1997 feed ban, received numerous comments on its Federal Register (70 FR 58570), FDA because doing so eliminates proposed rule. Based on these published a proposed rule (the October transmissions resulting from cross- comments, the agency has made some 2005 proposed rule) that would prohibit contamination and on-farm misfeeding. modifications to this final rule. the use of certain cattle origin materials The current U.S. ruminant feed Specifically, a statement has been added in the food or feed of all animals. The regulation (§ 589.2000 (21 CFR setting forth the purpose of the new materials identified in the proposal 589.2000)) prohibits the use of certain section, i.e., to prohibit the use of include the following: (1) The brains mammalian-origin proteins in ruminant certain cattle origin materials in the and spinal cords from cattle 30 months feed, but allows the use of these food or feed of all animals to further of age and older; (2) the brains and materials in feed for non-ruminant reduce the risk of the spread of BSE spinal cords from cattle of any age not animals. While the prevalence of BSE in within the United States. This change inspected and passed for human the United States is very much lower was made to clarify that the cattle consumption; (3) the entire carcass of than in European countries with BSE, materials prohibited by this rule are cattle not inspected and passed for evidence from the European experience being prohibited from use in all animal human consumption if the brains and has demonstrated that, in countries with food or feed because of their risk for spinal cords have not been removed; (4) a high level of circulating BSE transmitting BSE. This rule, however, tallow that is derived from the materials infectivity, measures on only ruminant should not be construed to mean that it prohibited by the proposed rule that feed were not sufficient to eliminate all is legal to use any portion of an animal contains more than 0.15 percent transmission of BSE; new cases that is adulterated under the Federal insoluble impurities; and (5) continued to be found in cattle born in Food, Drug, and Cosmetic Act (the act) mechanically separated beef that is the United Kingdom after in animal food or feed.
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