[Federal Register: April 25, 2008 (Volume 73, Number 81)] [Rules and Regulations] [Page 22719-22758] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr25ap08-8] [[Page 22719]] ----------------------------------------------------------------------- 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 [[Page 22720]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 589 [Docket No. 2002N-0273] (Formerly Docket No. 02N-0273) RIN 0910-AF46 Substances Prohibited From Use in Animal Food or Feed AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is amending the agency's regulations to prohibit the use of certain cattle origin materials in the food or feed of all animals. These materials include the following: The entire carcass of bovine spongiform encephalopathy (BSE)-positive cattle; the brains and spinal cords from cattle 30 months of age and older; the entire carcass of cattle not inspected and passed for human consumption that are 30 months of age or older from which brains and spinal cords were not removed; tallow that is derived from BSE-positive 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 prohibited by this rule. These measures will further strengthen existing safeguards against BSE. DATES: This final rule is effective April 27, 2009. 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 a certain publication in new 21 CFR 589.2001 effective April 27, 2009. FOR FURTHER INFORMATION CONTACT: Burt Pritchett, Center for Veterinary Medicine (HFV-222), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-453-6860, e-mail: burt.pritchett@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Table of Contents I. Introduction II. Comments on the Proposed Rule A. General Comments B. Comments on Proposed New Sec. 589.2001--Cattle Materials Prohibited in Animal Food or Feed C. Comments on Proposed Amendments to Sec. 589.2000--Animal Proteins Prohibited in Ruminant Feed III. Description of the Final Rule A. Definitions B. Requirements C. Recordkeeping and Access Requirements D. Changes to Sec. 589.2000--Animal Proteins Prohibited in Ruminant Feed IV. Analysis of Economic Impacts A. Summary of Final Regulatory Impact Analysis B. Cost Effectiveness of Final Rule and Alternatives C. Need for Regulation D. Benefits E. Costs F. Government Costs G. Sensitivity Analysis H. Regulatory Flexibility Analysis V. The Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) VI. Paperwork Reduction Act of 1995 VII. Environmental Impact VIII. Federalism IX. References I. Introduction BSE is a progressive and fatal neurological disorder of cattle that results from an unconventional transmissible agent. BSE belongs to the family of diseases known as transmissible spongiform encephalopathies (TSEs). All TSEs affect the central nervous system of infected animals. However, the distribution of infectivity in the body of the animal and mode of transmission differ according to the species and TSE agent. In addition to BSE, TSEs include, among other diseases, scrapie in sheep and goats, chronic wasting disease in deer and elk, and Creutzfeldt- Jakob disease in humans. The agent that causes BSE has yet to be fully characterized. The theory that is most accepted in the international scientific community is that the agent is an abnormal form of a normal protein known as cellular prion protein. The BSE agent does not evoke a traditional immune response or inflammatory reaction in host animals. BSE is confirmed by post-mortem microscopic examination of an animal's brain tissue or by detection of the abnormal form of the prion protein in an animal's brain tissues. The pathogenic form of the protein is both less soluble and more resistant to degradation than the normal form. The BSE agent is resistant to heat and to normal sterilization processes. BSE is not a contagious disease, and therefore is not spread through casual contact between animals. The possibility of maternal transmission (i.e., from a bovine dam directly to her offspring) was suggested by a 1997 study conducted in the United Kingdom. However, subsequent studies have shown that it is unlikely that maternal transmission of BSE occurs at any epidemiologically significant level, if it occurs at all. Scientists believe that the primary route of transmission requires that cattle ingest feed that has been contaminated with a sufficient amount of meat and bone meal (MBM) from an infected animal. This route of transmission can be prevented by excluding potentially contaminated materials from ruminant feed. Scientific and epidemiological studies have linked variant Creutzfeldt-Jakob disease (vCJD) in humans to exposure to the BSE agent, most likely through human consumption of beef products contaminated with the agent. As of February 2007, 165 probable and confirmed cases of vCJD have been reported in the United Kingdom. It is believed that in the United States, where measures to prevent the introduction and spread of BSE have been in place for some time, there is far less potential for human exposure to the BSE agent. The Centers for Disease Control and Prevention (CDC) leads a surveillance system for vCJD in the United States. As of November 2006, CDC had detected two vCJD cases involving United States residents who were born and raised in the United Kingdom. A third case was confirmed by CDC in November 2006 and involved a United States resident living in Virginia who was born and raised in Saudi Arabia and had lived in the United States since 2005. This individual did not live in Europe at any time, and CDC has determined that this person was most likely infected from contaminated cattle products consumed as a child when living in Saudi Arabia. On December 23, 2003, the U.S. Department of Agriculture (USDA) diagnosed BSE in an adult cow in the United States that had been imported from Canada. Since then, USDA has confirmed two other cases of BSE in adult cows in the United States. One cow, which was diagnosed on June 24, 2005, was born and raised in Texas. The other cow, which was diagnosed on March 15, 2006, had been on a farm in Alabama for less than a year. The Texas cow was 12 years old and the Alabama cow was determined to be more than 10 years old. Therefore, both cows were born before FDA's 1997 ruminant feed rule (62 FR 30936, June 5, 1997) was in place. Under USDA's enhanced BSE surveillance program, 787,711 cattle were tested between June 1, 2004, and September 20, 2006. As previously noted, only two animals tested positive for BSE, one in Texas and one in Alabama. In September 2006, USDA transitioned to an ongoing surveillance plan under which approximately 40,000 cattle are tested per year. [[Page 22721]] In the October 6, 2005, issue of the Federal Register (70 FR 58570), FDA published a proposed rule (the October 2005 proposed rule) that would prohibit the use of certain cattle origin materials in the food or feed of all animals. The materials identified in the proposal include the following: (1) The brains and spinal cords from cattle 30 months of age and older; (2) the brains and spinal cords from cattle of any age not inspected and passed for human consumption; (3) the entire carcass of cattle not inspected and passed for human consumption if the brains and spinal cords have not been removed; (4) tallow that is derived from the materials prohibited by the proposed rule that contains more than 0.15 percent insoluble impurities; and (5) mechanically separated beef that is derived from the materials prohibited by the proposed rule. The preamble to the proposed rule contained information regarding BSE, including a summary of the current animal feed safeguards in the United States and the risk of BSE in North America, other options FDA considered for strengthening animal feed protections, and the reasons for proposing to exclude certain cattle-derived risk materials from all animal food and feed. Also discussed in the preamble to the proposed rule was the Harvard Risk Assessment (referred to in the preamble to the proposed rule as the ``Harvard-Tuskegee Study''), completed for USDA in 2001. The authors released a revised risk assessment in 2003. Among other things, the Harvard-Tuskegee Study identified pathways or practices that, if addressed, could further decrease the already low risk of the spread of BSE if it were introduced into this country. In mid-July 2006, USDA's Food Safety and Inspection Service (FSIS) released a further revised Harvard Risk Assessment. Conducted in 2005, the risk assessment used an updated model to simulate the impact of measures adopted by USDA and considered by FDA in response to the detection of a BSE-positive cow in Washington State in December 2003. The 2005 study confirmed the original findings in the 2001 Harvard- Tuskegee Study and noted that, with the protective measures in place in the United States in 2003, the introduction of BSE would result in limited spread, and the disease would be eliminated over time. Of the additional feed-related mitigation measures evaluated, the revised model predicted that removal of specified risk materials (SRMs) from all animal feed would result in a substantial reduction of any residual BSE disease agent not eliminated by the 1997 feed ban, because doing so eliminates transmissions resulting from cross-contamination and on-farm misfeeding. The current U.S. ruminant feed regulation (Sec. 589.2000 (21 CFR 589.2000)) prohibits the use of certain mammalian-origin proteins in ruminant feed, but allows the use of these materials in feed for non- ruminant animals. While the prevalence of BSE in the United States is very much lower than in European countries with BSE, evidence from the European experience has demonstrated that, in countries with a high level of circulating BSE infectivity, measures on only ruminant feed were not sufficient to eliminate all transmission of BSE; new cases continued to be found in cattle born in the United Kingdom after implementation of a ruminant-to-ruminant feed ban. As stated in the proposed rule, these new cases were attributed to either cross- contamination during feed manufacture and transport, or to intentional or unintentional misfeeding on the farm. FDA believes that the presence of certain cattle-derived risk materials in the non-ruminant feed supply presents a potential source of exposure in the United States. Although in the United States, compliance with the 1997 ruminant feed rule by the U.S. animal feed industry, i.e., renderers, protein blenders, and feed mills, has been very high, inspections of feed manufacturing firms have identified some instances of inadequate cleanout procedures, mislabeling, and recordkeeping deficiencies. As discussed in the preamble to the proposed rule, data from both naturally infected and experimentally infected cattle indicate that roughly 90 percent of BSE infectivity is contained in the brain and spinal cord, and only about 10 percent of BSE infectivity is present in the retina, dorsal root and trigeminal ganglia, and the distal ileum (Ref. 1). The agency continues to believe that the 1997 ruminant feed rule provides a strong primary line of defense against BSE transmission by prohibiting the use in ruminant feed of all materials with potential BSE infectivity. The additional measures taken in this final rule will further reinforce the existing rule by removing certain cattle-derived risk materials from all animal feed. This action greatly minimizes the residual BSE risks not eliminated by the 1997 feed ban if cross- contamination of ruminant feed with non-ruminant feed, or diversion of non-ruminant feeds to ruminants, were to occur. As discussed in greater detail in section II of this document, FDA received numerous comments on its proposed rule. Based on these comments, the agency has made some modifications to this final rule. Specifically, a statement has been added setting forth the purpose of the new section, i.e., to prohibit the use of certain cattle origin materials in the food or feed of all animals to further reduce the risk of the spread of BSE within the United States. This change was made to clarify that the cattle materials prohibited by this rule are being prohibited from use in all animal food or feed because of their risk for transmitting BSE. This rule, however, should not be construed to mean that it is legal to use any portion of an animal that is adulterated under the Federal Food, Drug, and Cosmetic Act (the act) in animal food or feed. Under section 402(a)(5) of the act (21 U.S.C. 342(a)(5)), animal feed and feed ingredients containing material derived from a BSE- positive animal are adulterated because they are in whole or in part the product of a diseased animal. The definition of cattle materials prohibited in animal feed (CMPAF) has been revised to include the entire carcass of BSE-positive cattle. This change was made to be consistent with the agency's previous guidance entitled ``Use of Material from BSE-Positive Cattle in Animal Feed,'' for which a notice of availability was published in the Federal Register of September 30, 2004 (69 FR 58448). In that guidance, the agency made clear that it was not going to exercise enforcement discretion with regard to the use of BSE-positive cattle in animal food or feed. Therefore, this rule prohibits the use of BSE-positive cattle in all animal food or feed. Additional changes have also been made in this final rule to the definition of CMPAF. As defined in the proposed rule, CMPAF included the brains and spinal cords from cattle of any age not inspected and passed for human consumption (or the entire carcass, if brain and spinal cord were not removed). FDA explained in the preamble to the proposed rule its rationale for applying these requirements to cattle of any age. This rationale cited surveillance data showing that cattle not inspected and passed for human consumption were included in the population of cattle at highest risk of BSE, and noted that inspection programs were not in place in the rendering industry for verifying the age of dead cattle. However, given the challenges of removing the brain and spinal cord from this class of cattle, FDA specifically requested comment on this issue. [[Page 22722]] FDA has revised the definition of CMPAF in the final rule (proposed Sec. 589.2001(a)(iii) and new section 589.2001(b)(iii)) to prohibit the use of the entire carcass of cattle not inspected and passed for human consumption that are 30 months of age or older from which brain and spinal cord have not been effectively removed or otherwise effectively excluded from animal feed. As a result, the rule now prohibits the use of the entire carcass of cattle not inspected and passed for human consumption unless: (1) The cattle are shown to be less than 30 months of age, or (2) the brains and spinal cords were effectively removed or effectively excluded from animal feed use. The final rule was further revised to require renderers to develop and maintain written procedures for determining the age of and/or removing the brain and spinal cord from, dead cattle, and to make the written procedures available for FDA inspection. FDA notes that, for cattle not inspected and passed that are diseased or that died otherwise than by slaughter, the entire carcass of such animals is adulterated under section 402(a)(5) of the act. FDA has traditionally exercised enforcement discretion with regard to the use of such animals in animal feed. For example, see Compliance Policy Guide 675.400. FDA intends to continue exercising such discretion for the use in animal feed of: (1) The remaining material from cattle that are diseased or that die otherwise than by slaughter when the brain and spinal cord are effectively removed or effectively excluded from animal feed use and (2) the entire carcass from cattle that are diseased or that die otherwise than by slaughter if such cattle are shown to be less than 30 months of age. FDA made these revisions based on comments indicating that it is feasible to put processes in place to age such cattle and that very little risk reduction is gained by excluding material from such cattle. FDA also received many comments that raised concerns about the environmental impacts of disposing of these animals by means other than rendering them for animal feed use. FDA noted in the preamble to the October 2005 proposed rule (70 FR 58570) that European surveillance data suggest that cattle not inspected and passed for human consumption are more likely to test positive for BSE than healthy cattle that have been inspected and passed. However, FDA considered the level of risk reduction that might potentially be achieved by prohibiting materials from cattle that are not inspected and passed for human consumption and that are less than 30 months of age. FDA also considered the following: (1) Surveillance data indicate the current risk of BSE to U.S. cattle is very low, (2) the existing ruminant feed regulation provides strong protection against BSE, and (3) the new measures established by the final rule represent a secondary level of protection to address failures in compliance that may occur with the existing ruminant feed rule. After considering all of the previously mentioned factors, FDA determined that the proposed measure to prohibit materials from cattle that are not inspected and passed for human consumption and that are less than 30 months of age is not necessary. Based on comments received, FDA has added a provision to this rule so that the agency may designate a country as not subject to the new requirements in this rule. As explained elsewhere in this document, a country seeking such a designation must submit a written request and include information about the country's BSE case history, risk factors, measures to prevent the introduction and transmission of BSE, and any other relevant information. Lastly, for renderers handling cattle materials, this final rule provides, as did the proposed rule, that such renderers must establish and maintain records sufficient to demonstrate that material rendered for animal feed was not manufactured from, processed with, or does not otherwise contain CMPAF. Based on comments received regarding verification of CMPAF segregation in slaughter facilities, this final rule has been revised to clarify that the renderer's records must also include documentation that establishments supplying cattle materials to the renderers have adequate procedures in place to effectively exclude CMPAF. These supplier-related records must include either certification or other documentation from the supplier that material supplied to the renderer does not include CMPAF or documentation of another method, acceptable to FDA, such as third-party certification, for verifying that suppliers have effectively excluded CMPAF from animal feed. II. Comments on the Proposed Rule FDA received more than 840 comments on the proposed rule. They came from a wide variety of organizations, such as cattlemen, renderers, feed manufacturers, Federal agencies, State agriculture departments, trade associations, professional organizations, universities and research institutions, consumer organizations, and individuals. Many comments questioned the need for additional controls in light of the high compliance with FDA's 1997 feed rule by the U.S. animal feed industry, coupled with the low prevalence of BSE in this country. Some comments took the opposing view, stating that more aggressive steps should be taken by FDA and that all ruminant-derived material should be prohibited in all animal feed. Some comments urged that all exemptions (e.g., plate waste and poultry litter) be removed from the regulations. Other comments asserted that the proposed rule was not scientifically based and should not be finalized. Many comments from industry raised concerns about the increased burden--financial and otherwise--if the proposed rule is finalized. Some comments discussed the difficulty of ensuring complete removal of brain and spinal cord from dead cattle. Other comments expressed concerns about the increased volume of materials that would have to be disposed of through incineration, landfills, or other means. Potentially adverse environmental effects--and resultant adverse animal and public health consequences--from the increased volume of disposal materials were mentioned by several comments. Comments also expressed concerns about registration, certification, verification of segregation of CMPAF at slaughter establishments, recordkeeping, and record retention time. A description of the comments and FDA's responses follows. A. General Comments 1. Need for Additional BSE Safeguards (Comment 1) Many comments, in addressing the proposed rule generally, said that the current BSE feed regulation does not need to be strengthened. Reasons given for this position were the low prevalence of BSE in this country as shown by USDA's surveillance results, the conclusion of the original Harvard Risk Assessment that the United States is resistant to BSE, and the effectiveness of the current ruminant feed rule (Sec. 589.2000) as evidenced by the high rate of industry compliance and the absence of BSE cases in cattle born after the 1997 ruminant feed rule. One comment said that FDA should develop a more accurate estimation of BSE risk to U.S. cattle by entering USDA's most recent prevalence data into the Harvard Risk Assessment model. (Response) FDA agrees that the prevalence of BSE in the United States is very low, and that compliance with the current feed ban by the U.S. animal feed industry is at a high level. Though the situations are not directly [[Page 22723]] comparable, evidence from the European experience has demonstrated that BSE transmission can continue to occur even with a ruminant feed ban in place. FDA believes that eliminating the highest risk cattle-derived materials from the non-ruminant feed supply will further reduce the potential for cattle exposure to the BSE agent via cross-contamination of ruminant feed during feed manufacturing or transportation, or through on-farm misfeeding. As stated in the preamble to the proposed rule, without fully dedicated equipment, it may not be possible to completely prevent carryover of feed or feed ingredients even when cleanout procedures are in place. (Comment 2) One comment said that, because the cow found in Texas in June 2005 did not test positive as a typical case of BSE, this case does not support the need for additional regulation. (Response) FDA is aware that the PrPSC (disease-specific prion protein) isolates from the Texas and Alabama cases are atypical in that they have characteristics on immunohistochemical and western blot analyses that distinguish them from the typical BSE isolate. Because the significance of these differences, particularly with respect to origin and transmissibility, is not yet clear, the agency believes the atypical nature of these two cases does not diminish the need to strengthen BSE feed controls. (Comment 3) Several comments said that the proposed rule was not based on the BSE situation in the United States, but rather on the situation in Europe where the incidence of BSE was 500-fold greater and control measures were instituted after BSE cases were identified. One comment also thought FDA might have developed its proposal based on the BSE situation in Japan. (Response) While the data from Europe and Japan on BSE provided the agency with important information to help develop our response to BSE, the agency based its decision on the BSE situation in the United States and believes that these measures are appropriate to the United States situation. The agency believes, however, that the early firewalls (prohibition on imports of animals and ruminant feed from countries with BSE and the ruminant feed ban) put in place in the United States makes it possible and appropriate to strengthen feed controls with measures that are still less expansive than those that would be appropriate in countries with higher BSE prevalence such as in European countries and Japan. The measures being implemented are commensurate with the BSE prevalence in the United States. (Comment 4) Several comments declared that the recommendations in the International Review Team's (IRT) February 2005 report are not relevant to the development of this rule because they were not based on science, they do not reflect the difference in BSE risk between Europe and the United States, and they do not present an accurate understanding of the U.S. industry's compliance with the existing BSE feed regulation. (Response) FDA agrees that not all of the IRT recommendations are appropriate for the U.S. situation. However, FDA is adopting the IRT recommendation to require the removal of certain cattle-derived risk materials from all animal feed. FDA believes that the level of compliance with the current ruminant feed rule by the U.S. animal feed industry is high, but believes that the additional measures provide a secondary level of protection to address failures in compliance that may occur with the existing ruminant feed rule. (Comment 5) One comment said that cross-contamination is not a problem because the BSE prevalence is so low in the United States. Another comment asked for the data the agency is relying on to show that cross-contamination and feeding errors need to be controlled, especially since the agency's own statistics show the industry is in high compliance with the 1997 ruminant feed rule. (Response) FDA agrees that overall compliance with the 1997 ruminant feed rule by the U.S. animal feed industry has been high, but there have been instances of noncompliance with the rule that could have resulted in cattle being exposed to prohibited material through cross-contamination, mislabeling, or intentional or unintentional misfeeding. Information describing these instances of noncompliance was set forth in the preamble to the October 2005 proposed rule (70 FR 58570 at 58577). An updated summary of compliance information is provided in the References section of this document (Ref. 2). (Comment 6) A few comments asked FDA to recognize that the USDA 18- month surveillance snapshot may not be an accurate indication of BSE prevalence in the United States. Specifically, because the BSE cases to date are likely clustered in time and location, USDA's surveillance results may underestimate the true risk. (Response) FDA stated in the preamble to the proposed rule that the detection of one BSE case in over 418,000 samples analyzed under USDA's enhanced surveillance program at the time of the publication of the proposed rule indicates that the prevalence of BSE is very low in the U.S. cattle population. FDA notes that USDA has conducted surveillance for BSE since 1990. A July 20, 2006, USDA report entitled ``An Estimate of the Prevalence of BSE in the United States'' supports FDA's qualitative statement of a very low prevalence of BSE in the United States (Ref. 3). According to the report, a model developed in Europe was used to calculate U.S. BSE prevalence from two BSE cases detected in 735,213 samples collected over a 7-year period ending in March 2006. Results of this analysis support a conclusion that the prevalence of BSE in the U.S. cattle population is less than one infected animal per million adult cattle. FDA remains confident in the two models used by USDA. The most likely values calculated by these models for the estimated number of cases were 4 or 7 infected animals out of 42 million adult cattle. USDA's analysis was submitted to the scrutiny of a peer review process, and the expert panel agreed with the appropriateness of USDA's assumptions and the factors it considered, as well as with the estimate of BSE prevalence. (Comment 7) One comment noted that the effectiveness of the feed ban, especially at the farm level, is not known. (Response) Inspection results indicate that compliance by U.S. animal feed industry is high. However, FDA agrees that it is very difficult to assess compliance with the ruminant feed rule at the farm level. FDA believes excluding certain cattle-derived risk materials from all animal feed channels will minimize any residual risks from on- farm misfeeding. (Comment 8) Two comments indicated that the agency's feed control measures for ensuring compliance with the 1997 ruminant feed rule have been inadequate, citing a Government Accountability Office (GAO) study as evidence. (Response) FDA disagrees with these comments. FDA believes its enforcement activities are adequate for ensuring industry compliance with the 1997 ruminant feed rule. The agency's response to the GAO's study can be found in Appendix VI of the GAO's report (Ref. 4). (Comment 9) One comment speculated that, in some species, atypical BSE might be more pathogenic than typical BSE. (Response) FDA is not aware of any scientific evidence that atypical BSE is [[Page 22724]] more pathogenic than typical BSE. Therefore, the agency believes that the controls in this final rule are appropriate. (Comment 10) Several comments said the proposed rule will hamper BSE surveillance by reducing the number of cattle available for sampling. (Response) FDA has conferred with USDA on the development of this rule. Further, USDA's transition from enhanced BSE surveillance to ongoing BSE surveillance places greater importance on collecting samples where clinical histories on sampled animals are more likely to be available, such as on farms and at diagnostic laboratories, and less importance on sampling at rendering plants where clinical histories are usually not available (Ref. 5). 2. Other Approaches for Strengthening Feed Controls A number of comments recommended ways to strengthen feed controls that they believed would provide better protection than the measures proposed by FDA. (Comment 11) Several comments stated that the proposed rule does not go far enough, that it still allows materials derived from ruminant species to be fed to other species, and that it does not include any of the actions announced on January 26, 2004. Several comments suggested that no animal or mammalian products be allowed in cattle feed or in feed for any other food-producing animal species. One comment noted that, although the proposed rule is a small step in the right direction, it is inadequate to close the existing loopholes. Two comments stated that the proposal ignores some of the recommendations made by the IRT and other BSE experts. Several comments stated that the proposed rule would leave 10 percent of the potential infectivity in the feeding system. One comment stated that the 10-percent infectivity may represent 780 ID50 (ID50 is the amount of infective material that would result in a case of BSE in 50 percent of the cattle that consumed it). Another comment remarked that distal ileum should be removed from animal feed, regardless of the disposal problems this could cause. In contrast, several comments were supportive of the agency's reasoning behind the proposed rule. These comments stated that removal of brain and spinal cord from cattle 30 months of age and older is the single most important step that can be taken to prevent the amplification of BSE and thereby shorten the time it takes to eradicate any latent BSE infectivity that might be present but undetected in U.S. cattle. Some comments further noted that the proposal is consistent with the IRT recommendation regarding a staged approach to removing SRM from animal feed. (Response) The agency does not believe it is necessary, given the low prevalence of BSE in the United States, to prohibit all ruminant material from animal feed, nor is it necessary to prohibit all animal or all mammalian products in cattle feed. Our reasoning for deciding against the measures under consideration by FDA that were announced on January 26, 2004, and choosing instead to focus on certain cattle- derived risk materials was fully explained in the preamble to the October 2005 proposed rule (70 FR 58570 at 58578). In deciding to prohibit brain and spinal cord only from cattle 30 months of age or older, rather than the full list of SRMs, FDA considered the following: (1) Surveillance data indicate the current risk of BSE to U.S. cattle is very low, (2) the existing ruminant feed regulation provides strong protection against BSE, and (3) the new measures in this rule represent a secondary level of protection to address potential failures in compliance that may occur with the existing ruminant feed rule. FDA believes that the existing ruminant feed rule provides a strong line of defense by prohibiting the use in ruminant feed of protein derived from mammalian tissues. The additional measures in this final rule will further reinforce existing ruminant feed protection measures by removing the highest risk cattle-derived materials from all animal feed. (Comment 12) One comment stated that the agency's proposal was too broad and asked that the rule be limited to removal of brain and spinal cord from dead and antemortem condemned cattle 30 months of age or older. The comment said this would have captured the two BSE cases in Washington and Texas. (Response) FDA believes that the rule should apply to cattle slaughtered for human consumption as well as to cattle not inspected and passed for human consumption at antemortem inspection. Infected cattle that are over 30 months of age and in the preclinical stage of disease could pass antemortem inspection, yet still harbor significant levels of BSE infectivity in the brain and spinal cord. (Comment 13) Numerous comments suggested that FDA prohibit the use of blood in animal feed. Reasons mentioned were that blood has been shown to contain TSE infectivity in several species, that vCJD has been found to be transmitted through blood, and that emboli created by stunning could carry infectivity. One comment said that, with more sensitive detection methods, BSE infectivity may be confirmed in blood. In contrast, numerous comments said FDA should continue to allow the use of blood in animal feed because there is no scientific basis for prohibiting blood in cattle feed and because calf health is dependent on colostrum supplements, which include blood products. One comment said that the chair of the IRT committee stated that blood does not transmit BSE. (Response) As explained in the preamble to the proposed rule, FDA is not prohibiting the use of blood and blood products in animal feed because we believe such a prohibition would do very little to reduce the risk of BSE transmission. Although TSE infectivity has been demonstrated experimentally in the blood (Ref. 6) of sheep and rodents (Ref. 7), species differences in the involvement of the lymphoreticular system in TSE diseases suggest that these findings cannot necessarily be extrapolated to cattle (Ref. 8). Studies using mouse and cattle bioassays have so far failed to detect BSE infectivity in bovine blood (Ref. 9). While FDA agrees that more sensitive detection methods might some day demonstrate BSE infectivity in bovine blood, the agency believes that it is highly unlikely that the BSE agent is present in blood of infected cattle at levels sufficient to transmit disease through oral administration of processed blood products. This conclusion is based on the inefficiency of the oral route of transmission relative to the intracerebral route, which was used in unsuccessful attempts to detect BSE infectivity in bovine blood. FDA believes that the prohibitions in this final rule make it unnecessary to also preclude the use of blood in animal feed. (Comment 14) A number of comments requested that poultry litter not be permitted to be fed to cattle, citing several reasons. One comment asked that FDA determine actual risk before deciding that poultry litter is not a risk factor. One comment stated that feces were infectious in rodents orally challenged with scrapie. Another comment noted that, in the United Kingdom, when cattle are orally challenged, the feces must be treated as medical waste for 1 month post-challenge. Another comment stated that TSE agents may be present in the porcine/ poultry intestinal content, while still another comment stated that the 2001 World Health Organization/Food and Agriculture Organization of the United Nations/World Organisation for Animal Health (OIE) Technical [[Page 22725]] Consultation concluded that digestive contents and fecal material from livestock or poultry being fed meat and bone meal (MBM) potentially contaminated with BSE should not be used as an ingredient in animal feed. (Response) In the preamble to the October 2005 proposed rule, FDA provided calculations submitted in comments to the advance notice of proposed rulemaking (ANPRM) that published in the Federal Register on July 14, 2004 (69 FR 42288), showing that a cow would need to consume a very large volume of poultry litter to ingest an infectious dose of BSE, assuming that the poultry feed spilled into the litter was formulated with MBM derived from a BSE-infected cow. Based on this analysis, FDA believes that the risk of cattle exposure to an infectious dose of BSE through poultry litter is low. The measures contained in this final regulation should reduce that risk even further because removing CMPAF from all animal feed prevents BSE infectivity from reaching poultry in the first place. (Comment 15) Several comments disagreed with the need for prohibiting poultry litter in cattle feed if FDA finalizes the proposed measures. Two comments said that there is no scientific basis for prohibiting poultry material in ruminant rations. Another comment pointed out that banning poultry litter would create significant disposal issues. (Response) As discussed in the response to the previous comment, because the rule prohibits the use of the highest risk cattle-derived materials in all animal feed, FDA agrees that it is not necessary to prohibit poultry litter from being fed to cattle. (Comment 16) Several comments recommended that dedicated facilities and equipment be required in order to prevent cross-contamination. One comment disagreed, stating that requiring dedicated facilities would force some renderers to discontinue operations. (Response) As explained in the preamble to the October 2005 proposed rule (70 FR 58570 at 58584), FDA fully expects this final rule to reduce substantially the remaining risk associated with cross- contamination, and therefore does not believe that the rule needs to also require dedicated facilities and equipment. (Comment 17) One comment suggested a ``systems approach'' as a substitute for the measures presented in the proposed rule. This approach, according to the comment, would prohibit the entire carcass (except skeletal muscle) of mature dead cattle and the brain and spinal cord of mature slaughter cattle from all animal feed. It would also prohibit the use of hypobaric (vacuum) rendering for processing inedible ruminant material. The commenter submitted modeling data obtained using the Harvard Risk Assessment model, which showed that this approach is as protective of animal and public health as a complete SRMs ban, while creating a much smaller disposal challenge. According to the modeling results, the ``systems approach'' and the full SRMs approach would reduce cases of BSE by 97 percent and 99 percent, respectively. FDA's proposed measures would reduce new cases by 40 percent to 63 percent, depending on the effectiveness of brain and spinal cord removal. The comment acknowledged that the ``systems approach'' would initially create disposal challenges, especially in the dairy sector, but that cost-effective carcass disposal methods could be implemented. (Response) The difference between the comment's ``systems approach'' and the approach in this final rule is that the ``systems approach'' would exclude the entire carcass of dead cattle 30 months of age or older rather than only the brain and spinal cord. As the comment acknowledges, eliminating the rendering option (other than disposal rendering) for disposal of all dead cattle 30 months of age or older may create major disposal challenges in some regions of the country (see ``Environmental Assessment'' for this final rule, Docket No. 2002N-0273). Modeling results submitted by the same commenter in response to the ANPRM showed that eliminating vacuum rendering contributed very little to the effectiveness of the ``systems approach.'' The agency believes that excluding brain and spinal cord from all cattle 30 months of age or older, and not the complete list of SRMs, is the most appropriate course of action for the United States where the BSE prevalence is low and strong feed controls are already in place. (Comment 18) Citing the link of BSE cases in Alberta to hypobaric (or vacuum) rendering, one comment recommended that the use of hypobaric rendering be prohibited because it provides no TSE inactivation. (Response) FDA agrees that the cluster of BSE cases associated with a vacuum renderer in Alberta underscores the concern about the ability of this process to inactivate BSE infectivity. A major advantage of the measures in this final rule over other options considered is that they prevent the highest risk cattle-derived materials from all animal feed, thereby reducing concerns about vacuum rendering. (Comment 19) One comment said that FDA should prohibit the use of mammalian protein in feed for food producing animals, and cited the following recent research to support this position: Infectious dose may be smaller than previously thought: Attack rate studies in the United Kingdom have demonstrated transmission at a 0.001 gram (g) dose (no reference), 10 times lower than the 0.01 g dose described by FDA in the proposal. Repeated low dose exposure: A study in which scrapie was injected into mice (Jacquemot 2005) showed that repeated low doses caused scrapie when a single dose of the same size did not. A second study in which scrapie was administered orally to hamsters (Diringer 1998) showed a higher incidence of scrapie in hamsters receiving repeated doses than in hamsters receiving a single dose. Additional organs may be infectious: Disease-specific prion protein (PrP\sc\) was found in the kidney, pancreas, and liver of scrapie infected mice when inflammation was induced in these organs (Heikenwalder 2005). Another study showed PrP\sc\ in the urine of scrapie infected mice with kidney inflammation. A third study found PrP\sc\ present in mammary glands of sheep with mastitis (Ligios 2005). Interspecies barrier may be smaller than previously thought: Some studies have shown interspecies inoculation produced subclinical disease but not clinical disease, suggesting that previously assumed species barriers were not complete (Hill 2000). (Response) FDA is aware that BSE transmission has been demonstrated at a 0.001 g dose. FDA is also aware of the other recent scientific findings and considered this information as we were developing the final rule. The agency believes that the risks associated with repeated low dose exposure, infectivity in inflamed organs, and unapparent carriers of BSE infectivity are very low. The agency believes the risks of BSE infection are adequately addressed by the 1997 ruminant feed rule and this final rule, and that it is not necessary to prohibit all mammalian protein in feed for food-producing animals. (Comment 20) One comment noted that species which appear to be resistant may in fact be unapparent carriers and over time could become sources of the BSE agent. Another comment added that failure to detect infectivity in tissues of experimentally infected pigs and chickens might be due to insufficiently sensitive bioassay techniques. Another [[Page 22726]] comment suggested that because swine and poultry may be silent carriers, materials derived from swine and poultry should not be fed to cattle. (Response) These concerns were first addressed in the 1997 ruminant feed rule (62 FR 30936 at 30939). The agency has received no new information that would lead us to conclude that the additional measures suggested by these comments are needed to protect against BSE at this time. (Comment 21) Several comments said that FDA should remove the exemptions in the current feed rule, with the possible exception of the exemption for milk. (Response) As discussed in the preamble to the October 2005 proposed rule (70 FR 58570 at 58573), the agency considered eliminating certain of the current exemptions in the 1997 ruminant feed rule. However, as further discussed in that preamble, given low levels of BSE prevalence and high compliance with the 1997 ruminant feed ban, the agency determined that prohibiting the highest risk cattle-derived materials from all animal feed would be the most appropriate measure in the United States to further reduce the remaining risk of BSE infection not already addressed by the 1997 feed ban. Other responses to comments in the preamble to this final rule also discuss the agency's reasons for not eliminating certain exemptions in the 1997 ruminant feed rule. (Comment 22) Numerous comments suggested that the plate waste exemption be eliminated. Reasons cited were that plate waste could contain highly infectious material, FDA has not specified the reheating requirements sufficient to inactivate the agent, it could be a factor in the spread of scrapie, and it confounds feed testing. In contrast, one comment advised against eliminating the exemption, noting that potential infectivity in high risk material has already been removed from meat by USDA regulations. (Response) The exemption in the 1997 ruminant feed rule is specifically for ``inspected meat products which have been cooked and offered for human food and further heat processed for feed (such as plate waste and used cellulosic food casings)'' (Sec. 589.2000(a)(1)). FDA disagrees that it is necessary to eliminate the plate waste exemption because, since 2004, human food has been required to be free of SRMs by USDA and FDA (69 FR 1862, January 12, 2004 (affirmation of interim rule 72 FR 38699, July 13, 2007), and 69 FR 42256, July 14, 2004, respectively). 3. International Trade Issues The agency received a number of comments about trade, particularly about international standards related to feed controls for the prevention of BSE. (Comment 23) One comment stated that FDA should not place more importance on trade considerations than on animal health, while another comment asserted that the proposed rule does not meet international standards, and therefore export markets may remain closed to U.S. products. In contrast, another comment stated that the proposed rule would satisfy trading partners and should help to reopen export markets. (Response) FDA's mission is to promote and protect public health. The agency's regulations are issued to achieve this mission. FDA is also aware of the international trade obligations of the United States and considers these obligations in rulemaking. FDA believes that this final rule, while based on its mission to promote and protect the public health, is consistent with international trade obligations. (Comment 24) One comment stated that the OIE recommends that feed and certain other commodities from controlled risk countries should not be traded if they contain protein from brains, eyes, spinal cord, skull, or vertebral column from cattle 30 months of age or older, or contain protein from the distal ileum or tonsils from cattle of any age. The comment added that if these commodities should not be traded internationally, then they should not be used domestically. (Response) The OIE guidelines described in the comment apply to meat products for human consumption and ruminant feed. They do not apply to all animal feed. FDA also notes that these risk materials are already prohibited from all ruminant feed. As discussed throughout the preamble to this final rule, FDA believes further prohibiting brain and spinal cord from cattle 30 months of age and older in all animal food or feed is appropriate for the U.S. situation. (Comment 25) Several comments stated that FDA should harmonize its new BSE feed regulations with those proposed by Canada. One comment provided a recommendation on how the United States and Canadian feed regulations should be harmonized, suggesting that both countries prohibit dead and downer cattle and require the removal of brain and spinal cord from cattle 30 months of age and older at slaughter. In contrast, another comment stated that trade with Canada should be restricted because of inadequate feed controls and inadequate surveillance in Canada. (Response) The governments of the United States and Canada discussed the differences between their proposed regulations and considered options for aligning the two regulations. This led to a better understanding of each country's situation. Having considered the circumstances related to each of the BSE-positive cows and the control systems in place in Canada and the United States, FDA has concluded that measures in the 1997 ruminant feed rule and in this final rule are the most appropriate for the situation in the United States. (Comment 26) Australia and New Zealand commented that they should not have to meet the proposed FDA requirements for exporting feed products to the United States because both countries have BSE-free status. Further, they stated that such requirements are contrary to World Trade Organization obligations under the Sanitary and Phytosanitary Agreement. (Response) As stated previously, FDA is aware of the international trade obligations of the United States and has considered these obligations throughout the rulemaking process for this regulation. In the preamble to FDA's interim final rule on prohibiting the use of certain cattle materials in human food and cosmetics (69 FR 42256, July 14, 2004), FDA requested comment on standards to apply when determining another country's BSE status, providing an exemption for ``BSE-free'' countries, and how to determine that countries meet any standards that might be developed. On July 13, 2007, USDA's FSIS published a final rule ``Prohibition of the Use of Specified Risk Materials for Human Food and Requirements for the Disposition of Non-Ambulatory Disabled Cattle; Prohibition on the Use of Certain Stunning Devices Used to Immobilize Cattle During Slaughter'' (also referred to as ``the SRM final rule'') (72 FR 38700), which affirmed, with changes, interim measures implemented by FSIS to minimize human exposure to materials that could potentially contain the BSE agent. One change that FSIS made in the SRM final rule was to exclude from the definition of SRMs materials from cattle from a country that can demonstrate that its BSE risk status can reasonably be expected to provide the same level of protection from human exposure to the BSE agent as prohibiting the use of SRMs for human food does in the United States. In the preamble to the SRM final rule, FSIS explained that those countries that believe that they are eligible to have materials from their [[Page 22727]] cattle excluded from the definition of SRMs should provide sufficient scientific evidence to support their claimed BSE risk status, and FSIS would then develop criteria to evaluate the equivalence request. FDA has decided to adopt a similar approach, and will allow a foreign country to seek a designation from FDA by which the restrictions otherwise applicable to animal feed would not apply to cattle-derived material from that country. Any country seeking such a designation would have to provide sufficient scientific evidence to support its claimed BSE risk status. B. Comments on Proposed New Sec. 589.2001--Cattle Materials Prohibited in Animal Food or Feed 1. Definition of Cattle Materials Prohibited in Animal Feed (CMPAF) FDA received numerous comments addressing the definition of ``cattle materials prohibited in animal food or feed'' (CMPAF) as set forth in proposed Sec. 589.2001(a). While some urged that all deads and downers, regardless of age, be included in the definition, others suggested that younger cattle be excluded from the definition because of science showing a lower infectivity risk in this group. (Comment 27) Numerous comments suggested that FDA exclude all deads and downers, regardless of their age, from the feed chain because they contain the highest level of infectivity and because the Harvard- Tuskegee Study showed reduction of the risk of BSE transmission when these two categories of animals were eliminated from the feed stream. Several comments said that infectivity could be present in tissues other than brain and spinal cord. Specifically mentioned was new research showing infectivity in peripheral nerves, both in one cow using a new bioassay technique (Buschmann and Groschup, 2005 (Ref. 10)), and in a 94-month-old BSE infected cow in Japan using a western blot method. One comment said that subclinical infection could be present in cattle younger than 30 months of age. (Response) FDA disagrees that it is necessary to prohibit all cattle not inspected and passed for human consumption from all animal feed to prevent BSE infection. BSE has a long incubation period. Epidemiological data from the United Kingdom epidemic have demonstrated that, on average, cattle develop clinical signs 4 to 6 years after infection (Bradley 1991; Anderson 1996 (Ref. 11)), though the incubation period can be longer or shorter than 4 to 6 years. With BSE, as with other TSEs, the total amount of infectivity in an animal increases throughout the incubation period, reaching the highest load at the end, very close to the death of the animal. Infectivity is considered to increase exponentially after exposure, reaching 4.5 logs less than clinical cases by 50 percent of the incubation period, and 3 logs less than a clinical case at 70 percent of the incubation period (Comer and Huntly, 2003 (Ref. 12)). Therefore, FDA assumes that the benefit shown in the Harvard-Tuskegee Study of excluding animals that die on the farm from the animal feed chain (77 percent reduction in mean number of new cases) is primarily attributable to excluding older deadstock. FDA does not believe that studies showing BSE infectivity in peripheral nerves are sufficient to justify prohibiting all cattle not inspected and passed from use in all animal feed to prevent BSE infection. In the Buschmann and Groschup study, the experimental mice used were approximately 10 times more sensitive than cattle to the BSE agent, and the donor cow was showing severe signs of late-stage clinical BSE. Furthermore, based on end-point titration, incubation time, and transmission rate, the infectivity levels in peripheral nerves are extremely low compared to levels in brain and spinal cord. The mice were injected both intracerebrally and intraperitoneally, which is much more efficient than the oral route of administration. Therefore, the agency believes that very little BSE risk reduction would be realized if this final rule prohibited all cattle not inspected and passed for human consumption from use in all animal feed. (Comment 28) Several comments suggested that deads and downers under 30 months of age be allowed in non-ruminant feed without brain and spinal cord removal, pointing out that no risk reduction is achieved by this requirement, and that age of deadstock could be verified by dentition, records, animal identification systems, or an onsite inspection. One comment said that FDA should provide guidance to renderers for procedures to verify age of cattle. (Response). FDA agrees that very little BSE risk reduction would be realized by prohibiting from animal feed all cattle less than 30 months of age that were not inspected and passed for human consumption and from which brain and spinal cord had not been removed. In the preamble to the October 2005 proposed rule, the agency explained the rationale for the 30-month age criterion and stated that it should be applied in the animal feed context. However, the agency also explained that the decision to prohibit all cattle not inspected and passed for human consumption from which the brain and spinal cord were not removed from animal feed was based on the fact that procedures were currently not in place at rendering facilities to verify that firms were determining the age of cattle effectively (70 FR 58570 at 58578). Several comments suggested methods to determine the age of dead cattle, including animal identification systems, dairy herd records, dentition, body weight, or feed lot origin. Based on the limited scientific basis with regard to BSE risk reduction for prohibiting cattle not inspected and passed for human consumption less than 30 months of age and the comments suggesting ways to determine the age of such cattle, FDA has revised the definition of CMPAF in the final rule. The revised definition of CMPAF includes the entire carcass of cattle not inspected and passed for human consumption that are 30 months of age or older from which brains and spinal cords were not effectively removed or otherwise effectively excluded from animal feed. The final rule requires renderers to maintain written procedures if they remove brain and spinal cord from such cattle, or separate such animals based on whether or not they are 30 months of age or older. As suggested by one comment, FDA will issue separate guidance for industry on methods for determining the age of cattle. FDA will work with USDA to develop methods consistent with those of USDA. As FDA noted previously (70 FR 58570 at 58579), section 402(a)(5) of the act states that a food shall be deemed to be adulterated if it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter. Since the category of cattle defined in this final rule as ``cattle not inspected and passed for human consumption'' are animals that already fall within the category of animals referred to in section 402(a)(5) of the act as ``diseased animals or animals which died otherwise than by slaughter,'' any animal feed derived from such animals would be considered adulterated. However, FDA has traditionally exercised enforcement discretion with regard to the use of such animals in animal feed. For example, see Compliance Policy Guide 675.400. With the implementation of this final rule, FDA will no longer exercise enforcement discretion over those materials prohibited by this regulation (i.e., CMPAF) that are derived from cattle not inspected and passed for [[Page 22728]] human consumption. FDA intends to continue exercising such discretion (relative to section 402(a)(5) of the act) for the use in animal feed of material derived from such cattle that are not defined as CMPAF. This includes (1) The remaining material from cattle not inspected and passed for human consumption when the brain and spinal cord are effectively removed or effectively excluded from animal feed use and (2) the entire carcass from cattle not inspected and passed for human consumption if such cattle are shown to be less than 30 months of age. (Comment 29) One comment asked that downer cattle not be allowed in animal feed. (Response) Under the final rule, to prevent BSE, cattle not inspected and passed for human consumption are prohibited from use in animal feed unless they are shown to be less than 30 months of age or the brain and spinal cord are effectively removed or effectively excluded from animal feed. FDA originally included cattle of any age that were not inspected and passed for human consumption in the definition of CMPAF because: (1) European surveillance data suggested that cattle not inspected and passed for human consumption posed a higher risk for BSE and (2) we believed that processes were currently not established in the rendering industry for verifying the age of such cattle through inspection. However, FDA received comments on the feasibility of aging such cattle and on the relatively low risk reduction achieved by excluding such cattle if they were less than 30 months of age. FDA considered these comments, surveillance data indicating the current risk of BSE to U.S. cattle is very low, the strong feed protection provided by the existing ruminant feed rule, and the added secondary level of protection provided by the other provisions of this final rule. Based on these factors, FDA concluded that it was not necessary to include in the definition of CMPAF cattle not inspected and passed for human consumption that are under 30 months of age. (Comment 30) One comment requested that striated muscle from cattle that died otherwise than by slaughter be allowed to be harvested for use in non-ruminant feed. (Response) This final rule does not prohibit the use of cattle not inspected and passed for human consumption in animal feed if they are shown to be less than 30 months of age or if the brain and spinal cord are effectively removed or otherwise effectively excluded from animal feed. 4-D operations (plants that harvest skeletal muscle from dead, dying, diseased, or disabled cattle) that harvest skeletal muscle for such use as pet and mink food fall within the final rule's definition of renderer and must have written procedures in place describing the aging methods and specifying how brain and spinal cord, or parts of carcasses containing brain and spinal cord, will be effectively removed or effectively excluded from animal feed. As discussed in more detail in the response to Comment 28, FDA notes that the use in animal feed of materials from cattle not inspected and passed for human consumption that are diseased or that die otherwise than by slaughter is the subject of enforcement discretion. (Comment 31) One comment from a foreign country requested that FDA clarify whether beef recovered by Advanced Meat Recovery (AMR) systems from vertebral column, from which spinal cord has been removed, is permissible in animal feed. (Response) This final rule does not prohibit in animal feed an AMR product derived from the vertebral column of cattle from which spinal cord has been removed prior to the AMR process, provided that the other requirements of the final rule are also met. 2. Definition of Cattle Not Inspected and Passed for Human Consumption (Comment 32) Several comments stated that cattle carcasses and parts condemned on post-mortem inspection should not be considered CMPAF because some parts of the condemned carcass may have already been commingled with normal slaughter byproducts. The comments suggested that the definition ``cattle not inspected and passed for human consumption'' be changed to ``cattle that do not pass ante-mortem inspection.'' (Response) The agency did not intend for the purposes of this regulation that the carcasses of cattle condemned on post-mortem inspection be included in the definition of cattle not inspected and passed for human consumption. The agency intended this category of cattle to include cattle that had been presented to a slaughter establishment and rejected (did not pass ante-mortem inspection) as well as cattle that had not been presented to a slaughter establishment and, hence, were not subject to inspection by an appropriate regulatory authority. To clarify this, FDA is modifying the definition of ``cattle not inspected and passed for human consumption'' in this final rule to mean ``cattle that did not pass ante-mortem inspection by the appropriate regulatory authority. 3. Restrictions on Tallow (Comment 33) One comment stated that the proposal is unclear as to whether the 0.15-percent insoluble impurity standard applies to all tallow or only to tallow derived from CMPAF. The comment requested that the tallow standard only apply to CMPAF-derived tallow. (Response) The final rule defines tallow as CMPAF if it is derived from: (1) BSE-positive cattle or (2) from other CMPAF material and contains insoluble impurities greater than 0.15 percent. The existing Sec. 589.2000 has been changed to clarify that protein derived from mammalian tissues does not include tallow containing 0.15 percent or less insoluble impurities. The result of these changes is that tallow usage is more restrictive in ruminant feed than in feed for non- ruminants. All tallow that contains more than 0.15 percent insoluble impurities is prohibited in ruminant feed, but only tallow that contains more than 0.15 percent insoluble impurities and that is made from CMPAF is prohibited in the food or feed of all animals. (Comment 34) Five comments stated that tallow should be prohibited in animal feed. Two comments said that tallow should be entirely free of protein impurities. In contrast, another comment said that tallow from animals inspected and passed for human consumption with SRM removed should be allowed in animal feed without the 0.15 percent restriction. (Response) The agency disagrees that all tallow should be prohibited in animal feed or that tallow should be free of impurities to be used in animal feed. The OIE considers tallow with less than 0.15 percent insoluble impurities to be protein-free. Further, OIE guidelines recommend that tallow meeting this standard is safe for use in animal feed, regardless of the exporting country's BSE status. As explained in the proposed rule, the agency is concerned about protein impurities that may be present in tallow particularly now that an attack rate study in the United Kingdom has found that oral administration of a very low dose (1 milligram (mg)) of BSE-infected brain produced disease in 1 of 15 calves receiving the dose. The agency sought comment on its proposed action, but no comments were received that provided a scientific basis for the agency to modify its position. Therefore, FDA has decided to prohibit all tallow containing more than 0.15 percent insoluble impurities from use in ruminant feed, but prohibit only tallow that contains more than 0.15 percent insoluble [[Page 22729]] impurities an