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23 FDA Veterinarian 1 (2008)

handle is hein.animal/fdavt0023 and id is 1 raw text is: 2008 Vol. XXIII, No. I FDA's BSE Final Rule Published; New Requirements Imposed on Renderers by Walt D. Osborne, M.S., I. D., Assistant Editor A fter a rulemaking process that took 2-1/2 years, the Food and Drug Administration published on April 25, 2008 (73 F.R. 22720), a final rule that further strengthens existing safeguards against bovine spongiform encephal- opathy (BSE) in the United States. The new rule (21 CFR 589.2001) prohibits the use of the highest risk cat- tle materials in the food or feed of all animals. This measure augments FDA's 1997 rule (21 CFR 568.2000), which prohibits the use of mammalian-origin proteins in feed fed to ruminants, but allows the use of these materials in feed for non-ruminant animals. The Agency believes additional pro- tections are needed even though com- pliance with the 1997 rule has been extremely high, and no new BSE cases have been reported in the United States since March 2006, when the second of two U.S. cases of BSE was detected. The new rule is expected to further reduce any cattle exposure to the BSE agent not eliminated by the 1997 feed rule. It is important to note that new cases of BSE continue to be found in cattle born in the United Kingdom after implemen- tation of that country's ruminant-to- ruminant feed ban. Also, FDA inspec- tions of feed manufacturing firms have identified some instances of inadequate cleanout procedures, mislabeling, and recordkeeping deficiencies. The new rule, which becomes effec- tive April 27, 2009, is intended to miti- gate such compliance failures and pre- vent the potential transmission of the BSE agent through cross-contamination or on-farm misfeeding. As discussed in the preamble to the proposed rule, scientific data indicate that roughly 90 percent of BSE infec- tivity is contained in the brain and spi- nal cord of cattle, and only about 10 percent of BSE infectivity is present in such cattle parts as the distal ileum of the small intestine, the dorsal root and trigeminal ganglia, and the retina of the eye. For this reason, the new rule fo- cuses on the removal of cattle brain and spinal cord from animal feed. FDA received more than 800 com- ments to the October 5, 2005, proposed rule, including comments from indus- try, State and local governments, trade associations, academia, and consum- ers. Reviewing all of the comments and responding to them in the preamble to the final rule proved to be a time-con- suming task. In particular, comments challenging FDA's estimate of the cost of the new regulation necessitated a re-analysis of the economic impact of the rule. In response to the comments, some changes to the proposed rule are reflected in the final version. What is prohibited? IN THI FDA's new rule prohibits CVM's the use of the following cattle Lab materials in the food or feed of Geneti all animals: Rok * The entire carcass of BSE- Comb positive cattle; IIIn * The brains and spinal cords from cattle 30 months of age and older; * The entire carcass of cattle not in- spected and passed for human con- sumption that are 30 months of age or older from which brains and spi- nal cords were not removed; * Tallow that is derived from BSE-posi- tive cattle; tallow that is derived from other materials prohibited by this rule that contains more than 0.15 percent insoluble impurities; and * Mechanically separated beef that is derived from the materials prohib- ited by this rule. All of these materials constitute cat- tle materials prohibited in animal feed, or CMPAF. One change the Agency made in going from the proposed rule to the final rule concerns the requirement to remove the brain and spinal cord from dead stock cattle, that is, cattle that die of injury or disease before they are ever sent to slaughter. As defined in the pro- posed rule, CMPAF includes the brains and spinal cords from cattle of any age not inspected and passed for human (Continued, next page) S ISSUE Role in Regulating Advertising and cling of New Animal Drugs ........................ ic Variability in Dogs and Its Potential , in Drug Development ........................... 6 aling Escherichia (ol O) I 7:H7 Foodborne ss Under FDA', Critical Path Initiatiw ........9

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