13 January 2004 Source: http://www.access.gpo.gov/su_docs/aces/fr-cont.html ----------------------------------------------------------------------- [Federal Register: January 12, 2004 (Volume 69, Number 7)] [Notices] [Page 1694] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr12ja04-33] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF AGRICULTURE Office of the Secretary [Docket No. 04-001-1] Declaration of Extraordinary Emergency Because of Bovine Spongiform Encephalopathy Bovine spongiform encephalopathy (BSE) has been detected in the United States. BSE is a progressive neurological disorder of ruminants that results from infection by an unconventional transmissible agent. It appears that BSE is primarily spread through the use of ruminant feed containing protein and other products from ruminants infected with BSE. The disease was detected in the State of Washington and had not previously been detected in the United States. The presence of BSE presents a threat to U.S. livestock. It constitutes a significant danger to the national economy and a potential serious burden on interstate and foreign commerce. The Department has reviewed the measures being taken by the State of Washington to quarantine and regulate the herds in question and has consulted with appropriate State Government and Indian tribal officials in the State of Washington. Based on that review and consultation, and the scope of the impact of this event on the national economy, the Department has determined that the State may be unable to adequately take the measures necessary to quarantine and dispose of animals that may be infected with or exposed to BSE. Therefore, the Department has determined that an extraordinary emergency exists because of BSE in the State of Washington. This declaration of extraordinary emergency authorizes the Secretary to (1) hold, seize, treat, apply other remedial actions to, destroy (including preventative slaughter), or otherwise dispose of, any animal, article, facility, or means of conveyance if the Secretary determines the action is necessary to prevent the dissemination of BSE and (2) prohibit or restrict the movement or use within the State of Washington, or any portion of the State of Washington, of any animal or article, means of conveyance, or facility if the Secretary determines that the prohibition or restriction is necessary to prevent the dissemination of BSE. The appropriate State Government and Indian tribal officials in Washington have been informed of these facts. EFFECTIVE DATE: This declaration of extraordinary emergency shall become effective January 6, 2004. Ann M. Veneman, Secretary of Agriculture. [FR Doc. 04-623 Filed 1-9-04; 8:45 am] BILLING CODE 3410-34-P ----------------------------------------------------------------------- [Federal Register: January 12, 2004 (Volume 69, Number 7)] [Rules and Regulations] [Page 1874-1885] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr12ja04-26] ----------------------------------------------------------------------- DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service 9 CFR Parts 301, 318, and 320 [Docket No. 03-038IF] RIN 0583-AC51 Meat Produced by Advanced Meat/Bone Separation Machinery and Meat Recovery (AMR) Systems AGENCY: Food Safety and Inspection Service, USDA. ACTION: Interim final rule and request for comment. ----------------------------------------------------------------------- SUMMARY: The Food Safety and Inspection Service (FSIS) is issuing this interim final rule on meat produced by advanced meat recovery (AMR) systems. This new regulation is a prophylactic measure designed, in part, to prevent human exposure to the Bovine Spongiform Encephalopathy (BSE) agent by ensuring that AMR systems are not a means of introducing central nervous system tissue into product labeled as ``meat.'' In addition to the measures related to BSE, FSIS is finalizing restrictions related to bone solids and bone marrow for livestock products. This rule articulates the criteria that FSIS will use to ensure that AMR products can be represented as ``meat'' and thus are not adulterated or misbranded. Finally, the Agency is requiring that Federally-inspected establishments that process the carcasses or parts of cattle develop, implement, and maintain written procedures for the removal, segregation, and disposition of specified risk materials (SRMs), including non-complying product from beef AMR systems. Establishments must incorporate these procedures into their HACCP plans or in their Sanitation SOPs or other prerequisite program. FSIS is issuing this document as an interim final rule because of the discovery of a BSE-positive cow in this country. DATES: This interim final rule is effective January 12, 2004. Comments on this interim final rule must be received by April 12, 2004. ADDRESSES: Submit written comments to: FSIS Docket Clerk, Docket 03-038IF, Room 102, Cotton Annex, 300 12th Street, SW., Washington, DC 20250-3700. Reference materials cited in this document and any comments received will be available for public inspection in the FSIS Docket Room from 8:30 a.m. to 4:30 p.m., Monday through Friday. Reference materials that are not copyrighted will also be available on the FSIS Web site at http://www.fsis.usda.gov. All comments will be available for inspection in the FSIS Docket Room or on the FSIS Web site at http://www.fsis.usda.gov. FOR FURTHER INFORMATION CONTACT: Daniel L. Engeljohn, Ph.D., Executive Associate, Policy Analysis and Formulation, Office of Policy and Program Development, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250-3700; (202) 205-0495. SUPPLEMENTARY INFORMATION: Table of Contents Background [[Page 1875]] BSE Previous Rulemaking Discussion of Public Comments on Docket 96-027P Overview of this Interim Final Rule and Requests for Comment Emergency Action Codified Text Background The mission of the Food Safety and Inspection Service (FSIS) is to ensure that meat and meat food products are wholesome, not adulterated, and properly marked, labeled and packaged. Under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.), FSIS has the authority to determine that product is unfit for human food, i.e., adulterated, within the meaning of section 1(m)(3) of the FMIA (21 U.S.C. 601(m)(3)). Furthermore, a meat or meat food product is misbranded under any of a number of circumstances, including if its labeling is false or misleading in any particular; if it is offered for sale under the name of another food; if it is an imitation of another food, unless its label bears (in type of uniform size and prominence) the word ``imitation'' and, immediately thereafter, the name of the food imitated; or if it purports to be or is represented as a food for which a definition and standard of identity or composition is prescribed by regulations, unless it conforms to the regulations and its label bears the name of the food specified in the definition and standard (21 U.S.C. 601(n)(1), (n)(2), (n)(3), and (n)(7)). This interim final rule addresses both the adulteration and misbranding provisions of the FMIA. BSE Bovine Spongiform Encephalopathy (BSE) is a slowly progressive degenerative disease that affects the central nervous system (CNS) of adult cattle and is a member of the family of diseases known as transmissible spongiform encephalopathies (TSEs). TSEs also include scrapie in sheep and goats, chronic wasting disease in elk and deer, and variant Creutzfeldt-Jakob Disease (vCJD) in humans. The typical incubation period (the time from when an animal becomes infected until it first shows signs of disease) is believed to be from two to eight years. BSE was first documented in the United Kingdom in 1986, and has since been identified and confirmed in a number of other European and non-European nations. The agent that causes BSE and other TSEs has yet to be fully characterized. The theory that is most accepted in the scientific community is that the agent is a prion, which is an abnormal form of a normal protein known as cellular prion protein, although other types of agents have been implicated. FSIS has determined that this interim final rule is necessary to ensure that AMR systems are not a means of introducing CNS-type tissues (including brain, trigeminal ganglia, spinal cord, and dorsal root ganglia (DRG)), which have been identified as a potential source for the BSE infective agent into the food supply. Animal Age and BSE Infectivity Age-of-onset was known and recorded for approximately 135,000 cattle with confirmed clinical BSE in the United Kingdom between 1988 and August 2003. The age distribution data show that, of the cattle that developed clinical BSE in the field, only 0.01 percent were less than 30 months of age. Therefore, cattle younger than 30 months of age are less likely to be in the later stages of BSE incubation than older BSE-infected cattle and are less likely to contain high levels of BSE infectivity. For additional information about the onset of clinical BSE, see the interim final rule ``Prohibition of the Use of Specified Risk Materials for Human Food and Requirements for the Disposition of Non-Ambulatory Disable Cattle,'' Docket No. 03-025IF, also in this issue of the Federal Register. FSIS is providing a method for its inspection program personnel in slaughter establishments to use to determine the age of cattle when supporting documentation is not provided by the establishment. This is relevant to this rulemaking on advanced meat/bone separation machinery and meat recovery (AMR) systems because AMR systems generally are operated separate from slaughter operations. Thus, establishments will need to process skulls and vertebral columns under control programs (i.e., Hazard Analysis Critical Control Point (HACCP) plans, Sanitation Standard Operation Procedures (Sanitation SOPs), or prerequisite programs) separate from their slaughter operation controls. To ensure that the skulls and vertebral columns are appropriately handled, the slaughter establishment will need to provide documentation associated with the age of the skulls and vertebral columns to the receiving processing operation. Establishments using AMR systems will need to ensure that the skulls and vertebral columns are not from cattle 30 months of age and older. Infective Tissue In 2001, the European Commission's Scientific Steering Committee (SSC), an advisory committee for the European Union, considered the amount and distribution of BSE infectivity in a typical case of BSE and estimated that, in an animal with clinical disease, the brain contains 64.1 percent of the total infectivity in the animal, and the spinal cord contains 25.6 percent. According to the SSC, the highest remaining proportion of infectivity in a typical animal with clinical BSE is found in the DRG (3.8 percent). In experimentally infected cattle with clinical BSE, infectivity has been demonstrated in the brain, spinal cord, DRG, trigeminal ganglia, and the distal ileum of the small intestine. For additional information about BSE infectivity, see Docket No. 03-025IF. The Harvard BSE Risk Assessment In 1998, USDA commissioned the Harvard Center for Risk Analysis to conduct an analysis and evaluation of the current measures implemented by the government to prevent the introduction and spread of BSE in the United States and to reduce the potential exposure of consumers to the BSE agent. Using a probabilistic simulation model to characterize the consequences of introducing BSE into the country through a variety of pathways, the Harvard study concluded that the risk to consumers in the United States was low, and that the country is highly resistant to the spread of the disease, if introduced.\1\ In evaluating the potential risk mitigation actions that could be taken to further reduce the likelihood that BSE could spread to cattle or humans, the risk assessment recommended three courses of action. The first is to prevent infected or potentially infected animals or contaminated feed from entering the country. The second is to ensure compliance with Food and Drug Administration's (FDA's) ruminant feed ban. The third is to prohibit the infective materials of BSE-infected animals from entering both the human food and animal feed chains. The Harvard study divided potential sources of human exposure to BSE infectivity into two categories: Specific high-risk tissues and contamination of low-risk tissues. The former include, in order of infectivity, brain, spinal cord, DRG, distal ileum, trigeminal ganglia, and other tissues found in the head (e.g., eyes and tonsils). As for the latter, the Harvard study indicated that the most important means by which low-risk tissue can become contaminated is through the use of AMR systems that can leave spinal cord and DRG in the recovered meat product. [[Page 1876]] The AMR Process AMR systems are newer models of systems that have been used since the 1960s. The new systems emulate the physical action of hand-held high-speed knives for the removal of skeletal muscle tissue from bone through the use of hydraulic pressure. AMR systems apply pressure to detach the meat (skeletal muscle) tissue from the bones in a ``hard separation'' process. Desinewers that typically use belt pressure against a rotating perforated steel drum then separate meat from connective tissue, sinews, and other non-meat components in a ``soft separation'' process. In addition to vertebrae, typical bones processed by piston-driven AMR systems are brisket bones (breast or lower chest), rib bones, flat bones (scapulas), and hip bones (pelvis). AMR product is an intermediate product that is typically blended at about 5 to 12 percent of the formulation of ground products derived from manufacturing trimmings. Descriptive labeling for the product of AMR includes ``(species) trimmings, finely textured,'' ``finely ground (species),'' or any other term that accurately reflects its form. AMR technology enables processors to remove attached skeletal muscle tissue from livestock bones without incorporating significant amounts of bone and bone products into the final meat product. When produced properly, product from AMR systems is comparable to meat derived by hand deboning and can be labeled as ``meat'' (9 CFR 301.2). Under the FSIS regulations, spinal cord is not a component of meat, and therefore, product from AMR systems identified as ``meat'' that contains spinal cord is misbranded. Until today, FSIS has not taken regulatory action against ``meat'' containing DRG and other CNS-type tissues. From January through August 2002, FSIS conducted a survey of AMR products derived from the vertebral column of cattle to establish a baseline for the prevalence of spinal cord and DRG in beef AMR products (referred to as the 2002 Beef AMR Survey). In the 2002 Beef AMR Survey, the Agency found that while some establishments were able to consistently produce beef AMR product that was free of spinal cord and DRG, a majority of the establishments had difficulty keeping spinal cord and DRG out of their AMR products. Overall, FSIS found that that approximately 76% (25 of 34) of the establishments whose AMR product was tested had positive laboratory results for spinal cord, DRG, or both in their final beef AMR products. The survey also found that approximately 35% (89 of 256) of all final AMR product samples that were tested had positive laboratory results for spinal cord, DRG, or both. In March 2003, after completion of the 2002 Beef AMR Survey, FSIS implemented a routine regulatory sampling program of beef products from AMR systems as an additional measure to prevent misbranding of beef AMR products. Prior to the implementation of this regulatory sampling program, FSIS inspection program personnel collected AMR product samples for analysis for the presence of spinal cord tissue only if they believed that the establishment was not completely removing spinal cord from the vertebral column before the vertebral bones entered the AMR system (FSIS Directive 7160.2, April 14, 1997). Under the revised regulatory sampling program, FSIS inspection program personnel take samples of beef AMR product on a routine basis to verify that spinal cord tissue is not present in such product (FSIS Directive 7160.03, Revision 1, August 25, 2003). If spinal cord tissue is detected in beef AMR product, FSIS inspection program personnel take regulatory control action against the AMR product and equipment to prevent misbranded product from entering commerce. If the establishment has distributed misbranded beef AMR product, FSIS requests a voluntary recall. Removal of the spinal cord before the vertebral columns enter the AMR system does not always ensure that spinal cord or DRG will not be incorporated into the final product. The Harvard study (discussed below) found that, if a beef carcass is mis-split when the spinal cord is removed, a portion of the spinal cord may remain encapsulated in the spinal canal of the vertebral column, and, if it is not removed before the vertebral bones enter the AMR system, the spinal cord could contaminate the final AMR product. Even when the spinal cord is completely removed from the vertebral column, the DRG of cattle are firmly attached to the bones of the vertebral column and are not removed along with the spinal cord. Thus, removing the spinal cord from the vertebral column does not prevent the DRG from entering an AMR system and becoming incorporated into the final AMR product. Although FSIS and the regulated industry have recently taken actions to prevent the incorporation of spinal cord and, in some instances, DRG, in beef AMR products, FSIS continues to detect spinal cord and DRG in its routine regulatory sampling of beef AMR products, although to a lesser extent than it did in the 2002 Beef AMR Survey. In its routine regulatory sampling conducted from March to December in 2003, FSIS found spinal cord in 23 of 340 randomly scheduled samples, an estimated prevalence of 6.8 percent. In addition, the prevalence in follow-up samples was 13.6 percent, indicating that establishments with an initial positive continued to have some problems controlling for spinal cord in beef AMR systems. While FSIS was testing samples for spinal cord, FSIS also recorded the results for DRG. The prevalence for DRG was found in 10.9 percent of the samples in which DRG was recorded.\2\ Under the current regulations, AMR product that contains DRG, or any other CNS tissue except spinal cord, is not misbranded and can be identified as meat. However, given the nature of DRG and other CNS tissue except spinal cord, and the fact that BSE has been confirmed in a cow in the United States, FSIS has reconsidered its approach to the presence of all CNS tissues, particularly from cattle, as further discussed below. In addition, for a more complete explanation as to why skulls and vertebral columns of cattle 30 months of age and older are designated as specified risk materials (SRMs) and cannot be used in AMR systems, see Docket No. 03-025IF in this issue of the Federal Register. In addition to the measures identified to address BSE through restrictions associated with SRMs, FSIS also is identifying additional measures to restrict the use of beef product and spent bone materials associated with CNS-type tissues from cattle younger than 30 months of age, as described below. Finally, FSIS is finalizing new bone solids and bone marrow restrictions that are slightly modified from those previously proposed for livestock product labeled as ``meat.'' Previous Rulemaking In 1994, the Agency published a final rule (59 FR 62551) to amend the definition of ``meat'' to include product resulting from AMR systems. The 1994 rule reflected the Agency's position that calcium limits and the physical conformation of the bones exiting the system were sufficient to ensure that the production process was in control, and that the characteristics and composition of the resulting product were those of meat. The rule required that product resulting from the bone separation process not exceed a calcium content of 0.15 percent or 150 milligrams/ 100 [[Page 1877]] grams of product (150 mg/100 g) within a tolerance of 0.03 percent or 30 mg/100 g of product for each sample analyzed. The rule also required that the bones emerging from the AMR machinery be comparable to those resulting from hand deboning; that is, they must be essentially intact and in their natural physical conformation, such that they are recognizable as, for example, loin bones and rib bones, when they emerge from the machinery. Shortly after FSIS issued the 1994 rule, consumer groups expressed concern that the regulatory requirements for meat produced by AMR systems were not being met consistently. Consumer groups alleged that, in certain AMR operations, the starting materials and machinery were being manipulated to produce a product that conformed to the requirements for Mechanically Separated (Species) (MS(Species)), a finely comminuted meat food product that may include spinal cord and dorsal root ganglia (DRG), but not to the requirements for meat. (At the time, FSIS considered spinal cord to be central nervous system (CNS) tissue. However, FSIS did not include DRG within the meaning of CNS tissue. Rather, it considered DRG to be more a part of the peripheral nervous system instead of a CNS-type tissue because it was contained within the nexus between the spinal cord and the muscle tissue.) In 1995, FSIS conducted a survey of federally inspected meat establishments using AMR systems. Inspection program personnel in 13 of the 48 surveyed establishments reported results that were not in compliance with the requirements for AMR established in the 1994 rule.\3\ To determine whether the product that was being produced by AMR systems was compositionally consistent with hand-deboned meat, in 1996, FSIS began conducting a survey to profile the chemical and histological composition of meat derived from beef neck bones. Beef neck bones from the upper vertebral column are split during the slaughter dressing process, as opposed to long bones which generally are not split, and thus are inherently likely to contribute bone content (e.g., marrow) to the product resulting from the AMR system. Samples were found to contain spinal cord and fragments of other CNS-type tissue. FSIS concluded that the AMR product produced was likely not comparable to corresponding hand-deboned product, even when the calcium criterion of the 1994 rule was for the most part met. The results of the 1996 survey demonstrated that the provisions of the 1994 rule, if met, were not sufficient to ensure that AMR product would be comparable to hand-deboned meat in composition. A final report on the 1996 survey results is available in the Docket Room and on the FSIS web site.\4\ After considering information from consumer groups about compliance concerns, reviewing the 1995 field survey and the response to a 1996 notice soliciting public comment on that survey, and studying the results of the 1996 neck bone survey, FSIS concluded that it was necessary to propose amending its regulations and to issue a directive to inspection personnel to ensure that manufacturers were not incorporating spinal cord into AMR product labeled as meat. In 1997, FSIS published Directive 7160.2 to instruct inspection program personnel that establishments must completely remove spinal cord from any neck or back bones before the bones enter the AMR system. The directive emphasized that the definition of ``meat'' in 9 CFR 301.2 does not apply when the use of AMR systems results in product that contains spinal cord. FSIS did not address DRG in the directive because, at that time, FSIS did not have validated methodology to identify DRG, and DRG was not yet identified as a potential risk material. On April 13, 1998, FSIS issued a proposed rule (63 FR 17959), in which it stated that provisions in the 1994 final rule needed revision to prevent misbranding and economic adulteration of AMR product labeled as ``meat.'' Specifically the Agency proposed to: (1) Adopt performance standards for bone solids and bone marrow; (2) adopt a zero tolerance for the presence of spinal cord; and (3) delete the provision that focused upon the condition of the bones emerging from the AMR systems to determine whether or not the production process was in control. The Agency's objective was to ensure that the regulations provided clear standards for industry to meet. Prior to December 23, 2003, FSIS had not addressed AMR systems in the context of BSE, although FSIS had taken numerous steps to limit the presence of spinal cord in product derived from AMR systems. In particular, in March 2003, FSIS announced the results of the 2002 Beef AMR Survey and stated that FSIS soon would clarify its intent by rulemaking on AMR to ensure that DRG was excluded from the definition of product labeled as ``meat.'' By 2002, FSIS had a validated methodology to detect and discern DRG, there was widespread agreement within the scientific community that DRG was included within the meaning of CNS-type tissue, and there was scientific evidence that DRG carried the BSE infective agent. FSIS did not contemplate addressing tissues of brain and trigeminal ganglia in product from AMR systems because FSIS was not aware of any establishments using bone material, such as skulls, that would contain these tissues in the production of meat. Brain and trigeminal ganglia, along with spinal cord and DRG, all fit within the meaning of CNS-type tissues for purposes of further discussion in this document. Currently, FSIS does not analyze meat for tissues of brain and trigeminal ganglia. However, since skulls may in the future be used in AMR systems, FSIS is reassessing whether it should validate its testing methodology to detect and discern brain and trigeminal ganglia in product recovered from AMR systems. FSIS has concluded that the 1994 rule, the 1998 proposed rule, and the FSIS Directives will not keep spinal cord and other CNS-type tissue out of product derived from livestock, particularly cattle, that is labeled as ``meat.'' FSIS concludes that restrictions for CNS-type tissues need to be explicitly stated in the regulations, along with a requirement to have written process control procedures and testing by the establishment, to ensure that the process control procedures are effective in producing product labeled as ``meat.'' Furthermore, FSIS has initiated a survey on pork AMR products and believes that the lack of process control regarding the presence of CNS-type tissues in pork product recovered from AMR systems also may be a concern. The new requirements in this interim final rule are applicable, for the most part, to products derived from pork bones. FSIS has decided to publish this new AMR regulation as an interim final rule and to address both CNS-type tissues and the restrictions related to bone solids and bone marrow. The presence of spinal cord or other CNS-type tissue in AMR product, that is, in meat, particularly from cattle, represents a potential threat to the public health of the United States. The Administrator thus finds that there is good cause to make this new AMR regulation effective immediately. It is especially designed to prevent the occurrence of spinal cord and other CNS-type tissues in ``meat'' and meat food products derived from cattle, and to prevent the occurrence of spinal cord and other CNS-type tissues in ``meat'' derived from livestock other than cattle. Before explaining in more detail the provisions of this interim final rule, a [[Page 1878]] brief discussion of the comments received on the proposal and FSIS' responses follows. Discussion of Public Comments on Docket 96-027P The 60-day comment period on the 1998 proposed AMR rule ended on June 12, 1998. Forty-five comments were received from food and equipment manufacturers, professional and industrial trade associations, consumers and consumer advocacy organizations, academia, and consultants. On December 16, 1999, FSIS issued a notice (64 FR 70200) reopening the comment period for an additional 30 days to give the public an opportunity to review and comment on the methods and results used by Agricultural Research Service (ARS) scientists to derive new iron-to- protein values. The Agency also sought comment on a report submitted by a meat industry group regarding economic and worker safety issues relevant to the proposed rule. The reopened comment period closed on January 18, 2000. Twenty-six additional comments were received in response to the notice. The two sets of comments and FSIS' responses are merged in this ``Comment'' section. Bone Solids Comment: Many commenters disagreed with the proposed calcium requirement that was established as a measure of the bone solids content of AMR product, to ensure that AMR product is meat. One commenter stated that the limit was too high, and another suggested that the limit should be lowered to approximate the calcium level in hand-deboned meat, with a reasonable allowance for variation. Another commenter pointed out that FSIS asserted in the 1994 final rule that its purpose was to ensure that the characteristics and composition of AMR are consistent with those of meat. Another commenter claimed that the proposed reduction in the calcium level was arbitrary and determined on the basis of a limited data set and not based on actual process data. Another commenter requested that the calcium performance standard account for differences among meat species. Response: FSIS does not agree that the calcium standard should be based only on actual process data and does not agree that the calcium level for AMR products needs to approximate that of hand-deboned products. The calcium level in hand-deboned products is nearly negligible. The increased amount in the AMR product that the Agency proposed to allow represented a small amount of calcium that would not in any appreciable way affect the safety or quality of the product. When the vertebrae are split, increased bone dust (i.e., material high in calcium) is created and may accumulate in the AMR product. In hand- deboning, such material is less likely to be incorporated into the product. The calcium limit that FSIS proposed was based on the results of its 1996 survey and the data that were submitted to FSIS by industry. FSIS believes that this calcium limit can be consistently achieved by industry and represents a more appropriate level than that in the 1994 rule. Regarding the comment about different calcium levels for beef and pork, FSIS considered data for different species that were submitted by industry groups as well as the data gathered by FSIS in the 1996 survey. A summary of the data is presented in the technical addendum, which is available in the Docket Room and on the FSIS web page. The data show that average calcium levels for AMR pork and beef products are approximately 100 mg/100 g. FSIS believes that these data suggest that with regard to bone solids, there would not be any significant difference between pork and beef. Therefore, the required calcium targets for pork and beef AMR products are the same in this interim final rule. As mentioned above, in 1994, FSIS believed that the performance standards it established regarding calcium as a measure of bone solids content, and the physical conformation of the bones exiting the system were sufficient to ensure that the AMR production process was in control, and that the characteristics and composition of the resulting AMR product would be comparable to those of meat. However, based on the results of the 1996 AMR survey, FSIS concluded that the established performance standards, even if met, were not sufficient to ensure that AMR product would be comparable to meat and as a consequence proposed different standards in 1998. In particular, regarding compositional parameters, the 1996 results showed that the AMR products produced at the time were not comparable to hand-deboned product with respect to a number of measures, even when the calcium limit designed to measure bone solids content was met. The 1998 proposed rule identified a calcium limit of 130 mg/100 g product. This level was premised on a target average level of approximately 100 mg/100 g product but did not specify whether the 130 mg/100 g was an average or an absolute level. Data collected by the Agency and submitted by industry indicated that the average calcium level obtained for AMR pork and beef products is approximately 100 mg/ 100 g, but that there was wide variation in individual establishment results. Furthermore, the average of the calcium results in the 2002 Beef AMR Survey was below 100 mg/100 g, but again, there was wide variation in individual results. FSIS is clarifying in this interim final rule that no analysis can exceed the regulatory maximum of 130 mg/100 g sample. This level of calcium in the product does not affect the appearance, texture, or other quality aspects of the product and is a small amount of calcium when compared to the calcium content generally contained in MS(Species). In deciding on a calcium level, FSIS understands that it is virtually impossible for calcium levels in AMR product to be equal to those of hand-deboned product, which is essentially 0 mg/100 g. The presence of small amounts of calcium does not affect the qualitative characteristics of the product and only trivially affect its compositional aspects. Thus the standard will ensure that AMR product is ``meat.'' In addition, this standard creates a clear distinction between AMR product and MS(Species) product, which generally has more than triple the calcium of AMR. At the same time, FSIS has tried not to set such a low level for calcium that it would not be economically feasible to produce AMR product. Comment: A commenter thought that calcium samples should be taken at the intermediate stage of the AMR process, because at this stage the calcium samples would indicate whether bones are being broken or crushed. Response: FSIS is only concerned about the levels of calcium in the final AMR product as a means of ensuring that an excess amount of bone solids is not introduced into the product. It is not using a calcium measurement level to determine if bones are broken or crushed. Thus, FSIS is not including a standard to measure calcium at an intermediate stage in the AMR process in this interim final rule. Bone Marrow Comment: Commenters stated that the methodology and data used to derive the iron criterion that was proposed as a measure for noncomplying product were incorrect, and that, therefore, the proposed values were not appropriate. Specifically, it was pointed out that the analytical procedures used in the FSIS 1996 survey were based on procedures that understated iron values. Further, a commenter disagreed with the Agency's [[Page 1879]] approach of correlating histological data and the bone marrow cell assessment, with iron content. The commenter claimed that the correlation was not high, and thus was not accurate. A commenter agreed that a measurement of total iron is a good indicator of the presence of marrow in meat and further claimed that the amount of iron in beef is well established. However, there were many comments that questioned both using excess iron as a measure of bone marrow and the methodology used to establish the limit in the standard. A commenter suggested not using protein at all in adjusting the iron requirement but, rather, using a straight iron value level. A commenter suggested that FSIS needs to account for the fact that AMR procedures remove connective tissue that contains little or no iron, and that muscle adjacent to the bone is higher in iron than is hand- deboned muscle. Therefore, even if marrow components were absent, iron- to-protein ratios (IPRs) would be higher in AMR products than those in hand-deboned meat. Another commenter claimed that the use of iron as proposed by the Agency would be biased against low fat, high protein products and suggested a simple IPR. Some commenters said that the iron levels established were too high and urged FSIS to make the target levels more consistent with hand-deboned product. These commenters suggested a 5 to 10 percent variation in the IPR between AMR and hand-deboned meat. Commenters also suggested that establishments should not be permitted to determine their own IPR values, as was proposed. Response: FSIS will first address the measurement and methodology issue and then provide a justification for the excess iron measure it proposed. In the course of doing so, it will provide an explanation for the procedures that it used for deriving the iron performance standard contained in this interim final rule. Excess iron is the iron in excess of that which would be expected given the protein value if the product was meat. The measure for excess iron for the 2002 survey was: excFe=Fe-kP, where P is the protein (%), Fe is the iron (mg per 100 g), and k is a constant equal to 1.1 times 0.138. The 0.138 is the assumed IPR for the corresponding hand-deboned meat product, and the 1.1 is an adjustment factor. Measurement and methodology. While the measurement used by FSIS was accurate, the Agency agrees that the methodology and measurement procedures used in developing the standards for iron in the 1998 proposed rule were not consistent with common laboratory analyses for iron measurement. FSIS used a hydrochloric acid wet-ash digestion procedure to measure the iron levels of samples collected in the 1996 survey because this methodology was considered faster and less labor intensive than traditional dry-ash procedures (i.e., dry-ash procedure for digestion). The wet-ash procedure predictably underestimates the true level of iron. In contrast, the method used by ARS scientists, which is based on a dry-ash procedure for digestion, dries the samples and obtains iron results approximately double those obtained by the FSIS procedure. Further, the results obtained by the ARS dry-ash procedure are more consistent with levels previously reported for hand- deboned product in Agricultural Handbook 8 (now called USDA Nutrient Database for Standard Reference, Release 12). ARS analyzed split samples from the 1996 survey for FSIS, and FSIS used the ARS results along with more current FSIS data for deriving the standards for iron in this interim final rule. For samples in which there were no dry-ash procedure results, the FSIS wet-ash procedure results were multiplied by 2.11, which is the average ratio of the results from the dry-ash procedure to those that FSIS found using the hydrochloric acid wet-ash procedure (See the technical addendum for additional information in the FSIS docket room and on the web site).\5\ FSIS agrees with the commenter's concern about FSIS'' approach of correlating histological data and bone marrow cells with iron content and thus is not including a standard for bone marrow cells in this interim final rule. Although bone marrow cells are unique to bone marrow, they have been found in hand-deboned product probably as a consequence of contamination of the muscle tissue during the carcass splitting process during slaughter. FSIS justification for using excess iron as a measure of bone marrow. FSIS has determined that there is no practical methodology to measure bone marrow using commercial practices. Bone marrow contains many of the same components as muscle tissue and blood. Therefore, FSIS sought to establish in the 1998 proposal a practical methodology that would predict whether the known composition of hand-deboned meat was sufficiently different from AMR as a consequence of the incorporation of bone content (other than calcium) in AMR. FSIS deemed this additional bone content to be an indication of the presence of bone marrow. Consequently, iron, which is contained in marrow and in blood tissue, was chosen as a practical surrogate for bone marrow. To determine whether there were excess iron levels in AMR, and thus bone marrow in this product, the Agency proposed using an adjustment based on the protein value because an analysis of the data from a prior survey demonstrated that there was a correlation between iron and protein results. Protein levels will change with iron levels, everything else being equal. If bone marrow, which has a higher IPR value than meat, is added to product, the measured IPR value would be greater than the IPR for corresponding hand-deboned product without bone marrow. Accounting for measurement error, if this difference is large enough, it can then be concluded that bone marrow at more than a negligible amount is in the product. One of the commenters pointed out that a problem with the above model is that the AMR process removes connective tissue that contains little or no iron. The Agency believes that the effect of this removal is not large and would not change the basic premise of the model presented above. From the 1996 FSIS survey, the Agency determined that the average difference in protein between pre- and post-desinewed AMR product was about 0.5 percent, based on a post-desinewed product average protein of about 16.5 percent. Therefore, as a percentage of protein, the amount of protein associated with connective tissue removed during the desinewing step averaged only about 3 percent and does not represent a large proportion of the protein that is in the final product. In addition, it is possible that, during AMR processing, some unbound water is removed which would result in the removal of some water-soluble protein and dissolved solids.\6\ FSIS recognizes that these two factors, removal of connective tissue with low iron and protein and removal of unbound water, may result in an increase in the IPRs of AMR product. However, FSIS does not believe that such a possible increase renders the use of an excess iron measurement inaccurate for assessing AMR process control. Although FSIS does not believe that the effects of these factors would be substantial, it has taken them into consideration in this interim final rule and is using a 10 percent factor for adjusting the protein levels used for calculating levels of excess iron in AMR product. Another issue raised by the commenters regarding the appropriateness of the excess iron [[Page 1880]] measurement was that meat close to the bone has higher IPRs than meat farther from the bone. FSIS agrees with the commenter. However, the IPRs would be expected to be higher in AMR product than in hand-deboned product, even though no bone marrow would be introduced. FSIS has decided to allow alternative IPRs to be used in this interim final rule to reflect the inherent differences that exist among starting products. Regarding the comment made that the use of the excessive iron measure as proposed would be biased against high protein and low fat products, FSIS believes that for practical purposes, the difference between the excessive iron and the IPR calculations is not great. In this interim final rule, however, FSIS is adopting a different excess iron limit measurement than the one proposed in 1998. This new limit is based on a more current examination of excess iron measurements for hand-deboned product from the 2002 survey of AMR product. See footnote 1 in new Sec. 318.24(c)(1)(ii) for a detailed explanation of the formula derived for the excess iron value measurement. An assumption used by FSIS in the derivation of the excess iron value measurement for this interim final rule was that there would be duplicate measurements of iron and protein taken by establishments on an individual sample. Performing duplicate measurements on an individual sample is recommended because, on a few occasions in the 2002 survey, large differences for samples were found when duplicate measurements were made. Thus, to ensure that AMR product is consistent with meat, FSIS is adopting a measured 3.5 mg/100 g excess iron limit based on duplicate analyses of samples of AMR product. Related Comments Comment: Several commenters alleged that FSIS has singled out AMR technology for scrutiny while products derived from a low temperature rendering process (LTRP) were approved by FSIS for the school lunch program without any scientific basis or public input. The suggestion was made that FSIS withdraw the proposed rule on AMR products until comparable rules to regulate LTRP products have been developed and implemented. Response: The Agency has focused on meat produced by AMR systems because it is the main product not produced by hand-deboning, and is a product in which constituents not expected in boneless meat can be incorporated as a result of the process used for its production. Other technologies, such as LTRP, generally involve the removal of components such as fat and muscle. The Agency intends to further evaluate how it regulates other types of operations that are used to manufacture meat and poultry trimmings from various starting materials. The Agency seeks more specific comment and data on the compositional characteristics of LTRP and similar products derived from non-AMR systems. Comment: A commenter said the proposal was based on an antiquated regulatory foundation because the definition of meat is obsolete and is, in effect, an anatomical description. In addition, the commenter maintained that the proposal was an attempt to relate a chemical constituent of AMR-derived product to the former USDA Handbook 8 references for regulatory purposes and conflicted with Agency policies regarding constituents of other meat products. Response: Meat is defined in anatomical terms, and not chemically, because it is directly obtained from livestock and not chemically derived from other elements. Therefore, the regulatory definition of meat refers to the parts of livestock that are edible (as opposed to inedible parts/organs). The former Handbook 8 details the composition of foods but does not represent a formula for making ``meat.'' FSIS is not relating a constituent of AMR product to former Handbook 8 data on the composition of meat. AMR product is meat unless it includes constituents such as spinal cord and DRG that are not expected constituents of boneless meat. In addition, FSIS has determined that AMR product is meat unless the process by which it is produced incorporates expected constituents, such as calcium and iron, at excessive levels. Comment: A commenter asked about FSIS' response to the report on AMR technology and on worker safety issues related to AMR systems.\7\ Response: Regarding the report, which was produced by the Georgetown University Center for Food and Nutritional Policy, FSIS generally agrees with the historical and technical aspects of the report on AMR systems. The report addressed the disagreements that have characterized the regulated introduction of mechanical deboning in this country, and how these initiatives have attracted the attention of consumer advocacy groups. The 1999 report states that the presence of CNS tissue in meats of any kind should be avoided and cited FSIS' prohibition against spinal cord in AMR meat since 1997. The report discussed the reduction in worker-related injuries as perhaps the greatest societal advantage of AMR systems. FSIS agrees that manual deboning and the use of motorized knives are dangerous because they are associated with direct injuries and cumulative trauma disorders (CTDs). The report noted that some studies have demonstrated a 38 percent increase in CTDs as a consequence of working in deboning operations. FSIS agrees with the statements in the report about the efficiency of AMR systems that makes meat processing operations more safe and profitable. However, for the reasons presented in this interim final rule, the Agency disagrees with the Sparks report's assertion that further rulemaking to refine the 1994 final rule is unwarranted. Comment: A commenter asked whether FSIS agreed with the cost estimates in the Sparks Companies, Inc., report, which provided an economic analysis of the 1998 proposed AMR rule.\8\ Response: FSIS does not agree with some of the conclusions in the Sparks report. For example, FSIS believes that it is unlikely that all AMR systems will be removed and replaced with tertiary hand-deboning procedures, as the report suggests. Not all of the AMR systems are used to process split vertebral columns with exposed and extruding bone marrow tissue. Some systems are used to process only brisket or sternum and rib bones. The expected continued use of non-vertebral bones in AMR systems would considerably reduce the capital cost loss of $40 million estimated in the report. The report's discussion of capital costs also fails to take into account depreciation of the AMR systems since 1994, which would considerably reduce the capital cost loss. In addition, the cost of auto-knives may be somewhat over-estimated because the report assumes that the knives depreciate within a year. FSIS would suggest that the authors of the report should have used only the flow of services of the knives, not the depreciation of the entire capital stock of the knives within a year. However, the report was helpful and provided the Agency with important data to gauge volume and yield data, for example, and to gain a greater understanding of the extent of the AMR beef and pork industry in this country. These comments and all of the other public comments submitted in response to the 1998 proposal are available for review in the FSIS Docket Room and at the FSIS Web site. [[Page 1881]] Consumer Group Petition Because of its concerns about the presence of spinal cord and DRG in AMR product, in 2001, a consumer group, the Center for Science in the Public Interest (CSPI) on behalf of other consumer and public health associations, petitioned USDA to institute regulatory actions to prohibit spinal cord and DRG in AMR beef products.\9\ In addition, a consortium of 14 animal welfare, farmer, environmental, and public health groups voiced similar concerns and urged USDA and the FDA to take immediate regulatory action.\10\ 2002 Survey of AMR Products In order to assess the current industry practices associated with AMR systems, the petition submitted by CSPI, and the need for further Agency action with regard to AMR, the Agency determined that it needed to conduct a survey of AMR systems (i.e., the 2002 Survey of AMR Products). Another purpose of this survey was to characterize the recovered product of AMR systems regarding texture and appearance, look at current production practices (e.g., pressure settings and type of source materials) and yield data, and determine how those practices influence the calcium and iron levels of the final product. In January 2002, FSIS began collecting random samples from the 42 piston-driven AMR systems in production at 34 establishments harvesting AMR product derived from beef vertebrae or beef vertebrae mixed with other types of beef bones. Several establishments had more than one operating AMR system processing beef vertebrae. Over a 7-month period, samples from each AMR system that uses beef vertebrae as source material were randomly collected. An FSIS laboratory tested the products for the presence of spinal cord and DRG. At random times over the 7-month period, FSIS collected final (after the desinewer) product samples and intermediate (before the desinewer) samples from each of the active machines. In addition, the AMR system model and identification number, type of starter (input) product, and the maximum pressure applied and pressure hold or dwell time (at the maximum pressure) of the systems were noted. Most of the samples also were tested for the food chemistry constituents calcium, iron, and protein. Although some of the establishments (4 of 34 or 12 percent) were able to produce final AMR product with no spinal cord or DRG on a consistent basis (based on all (six or more) samples being negative), other establishments consistently produced samples that tested positive for spinal cord and DRG. For the survey, approximately 35 percent of the final AMR product samples tested positive for spinal cord or DRG: 29 percent for spinal cord and 10 percent for DRG. The occurrence of spinal cord and DRG was not considered to be significantly correlated; that is, the presence of one of these tissues in a sample did not significantly affect the likelihood of the presence of the other. This lack of significant correlation suggests that there may be different factors that determine the presence of these tissues in AMR product. On the other hand, estimated values of excess iron and calcium were positively correlated, suggesting that there is a common set of factors that influence their levels. See the final report on the 2002 survey results in the FSIS Docket Room or at the FSIS web site for additional details.\11\ FSIS Directive 7160.3 In August 2003, FSIS issued Directive 7160.3, Revision 1, to provide instructions to inspection program personnel for sampling boneless comminuted beef products from AMR systems in which vertebral columns are used and on actions to take if the product contains spinal cord.\12\ The directive did not address the presence of DRG tissue in AMR product because the Agency had not included DRG in the 1998 proposed rule. After doing follow-up verification sampling, the Agency was especially concerned that some establishments were not adequately addressing the problem of spinal cord in AMR product. The directive defined the range of follow-up actions available to the Agency when product from an AMR system is found to contain spinal cord tissue. FSIS withheld label approval for those establishments whose AMR system repeatedly failed to produce product that was free of spinal cord. Thus, these establishments effectively were not allowed to produce AMR meat from beef vertebrae. Overview of This Interim Final Rule and Request for Comments FSIS is amending the meat inspection regulations in Parts 301, 318, and 320 of the Code of Federal Regulations by modifying the definition of ``meat;'' adding or modifying non-compliance criteria for bone solids, bone marrow, brain, trigeminal ganglia, spinal cord, and DRG; requiring the development, implementation, and maintenance of a written program, including documentation and recordkeeping requirements, for ensuring process control; and declaring inedible the skulls and vertebral column bones from cattle that are 30 months of age and older. As indicated in a new Section 310.22, which is adopted in another interim final rule issued today (see Docket 03-025IF in this issue of the Federal Register), skulls and vertebral column bones from cattle 30 months of age and older are inedible and cannot be used for human food. Therefore, if skulls or vertebral column bones from cattle 30 months of age and older are used in AMR systems, the product exiting the AMR system is adulterated, and the product and the spent bone materials are inedible and cannot be use used for human food. For AMR product derived from the bones of cattle younger than 30 months, the presence of CNS-type tissues will render the product misbranded. Similarly, for AMR product derived from the bones of livestock other than cattle, the presence of CNS-type tissues will result in misbranding. For AMR product derived from the bones of all livestock, the restrictions associated with bone solids and bone marrow also relate to misbranding. FSIS is amending Sec. 301.2(b), the definition of ``meat'' to make it clear that boneless meat may not include significant portions of bone or related components, such as bone marrow, or any amount of CNS- type tissues. Therefore, product produced using an AMR system must not include significant amounts of bone or related components. It also must not include any brain, trigeminal ganglia, spinal cord, or DRG. Section 318.24(a) provides that skulls and vertebral column bones of cattle 30 months of age and older, as provided for in a new section 310.22 which is adopted in another interim final rule issued today (See Docket 03-025IF in this issue of the Federal Register), cannot be used in AMR systems. In addition, the recovered meat product exiting the AMR system must not significantly incorporate bone solids or bone marrow, as measured by the presence of calcium and excess iron, and cannot contain any brain, trigeminal ganglia, spinal cord, or DRG. Section 318.24(b) provides that establishments operating AMR systems are required to develop, implement, and maintain procedures that ensure that their production process is in control. The establishment must incorporate its production process procedures in a written program that is designed to ensure the ongoing effectiveness of the process control program. Because of the food safety concerns presented by SRMs, for establishments that process [[Page 1882]] cattle, the written program must be in the establishment's Hazard Analysis and Critical Control Point (HACCP) plan, or in its Sanitation Standard Operating Procedure (Sanitation SOP) or other prerequisite program. By declaring SRMs inedible and prohibiting their use for human food, FSIS will ensure that materials that could present a significant risk to human health, but whose infectivity status cannot be readily ascertained, are excluded from the human food supply. Because BSE was recently confirmed in a cow in the United States, FSIS has determined that the SRMs, adopted in another interim final rule issued today (see Docket 03-025IF in this issue of the Federal Register), are unfit for human food. Thus, the status of these materials has changed from edible to inedible. Such a change is likely to affect the underlying hazard analysis that must be conducted as prescribed by 9 CFR 417.4(a)(3). Therefore, in response to this change, FSIS expects that establishments that slaughter cattle or process carcasses or parts of cattle will reassess their HACCP plans in accordance with 9 CFR 417.4(a)(3) to address SRMs. Under Sec. 318.24(b), the written program must include the observation of bones entering the AMR system and the testing of the product exiting the AMR system. The establishment shall maintain records on a daily basis sufficient to document the implementation and verification of its production process. The establishment shall make the documentation available to inspection program personnel. Section 318.24(b) makes clear that establishments will be expected to determine how and when they will test product for calcium, iron, spinal cord, and DRG. Based on the supporting documentation provided by the establishment, and FSIS's own verification, FSIS will make a determination whether the product is misbranded or adulterated. FSIS expects that the establishment will ensure that each production lot is in compliance with the provisions of this regulation. Regarding the testing methodology for spinal cord and DRG, FSIS will continue to use its validated histological procedures. However, FSIS is aware that establishments have access to methodology that is not as specific or sensitive as the FSIS methodology and that is considerably less expensive to perform. FSIS encourages establishments to use any methodology that is effective. FSIS cautions establishments, however, that if the establishment's methodology is not adequate to discern complying product from non-complying product, FSIS will ensure that non-complying product is not allowed to enter commerce. Because of the expense and time associated with highly sensitive and specific tests, such as the methodology used by FSIS, researchers have been working on quicker and less costly tests. One such research effort has employed ELISA technology. For the 2002 AMR beef survey, an ELISA procedure was examined by FSIS, but FSIS concluded that the test was not sufficiently specific or sensitive. Not only were there many false positive and negative results (when compared to the FSIS histological results), the rates of false positive and negative results were establishment dependent. This latter finding could imply that there was some other component in the product interfering with the test. FSIS is aware that there are a number of research efforts underway to improve the sensitivity and specificity of the rapid tests that can be used in lieu of the normative histological tests for evaluating the presence of spinal cord and DRG. FSIS does not want to preclude the use of such tests by establishments. Therefore, FSIS is soliciting information during the comment period on alternative test methods and performance specificity and sensitivity. FSIS is interested in identifying a test for use by establishments that is as sensitive to the presence of spinal cord and DRG in product as the histological test employed by FSIS, but that is less expensive and less time consuming. The production process is not in control if the skulls of livestock entering the AMR system contain any brain or trigeminal ganglia tissue, or the vertebral column entering the AMR system has any spinal cord. In addition, the process is not in control if the recovered product contains unacceptable levels of bone solids or bone marrow, or any level of spinal cord or DRG, as provided for in Sec. 318.24(c). In addition, the production process is not in control if the product is not properly labeled or spent bone materials are not properly handled. Section 318.24(c)(1) describes the five criteria that define when recovered AMR product may not be used and labeled as ``meat.'' They include a measure for excess bone solids (calcium content above the stated level); a measure for excess bone marrow (iron in relation to protein above the stated level); the presence of brain or trigeminal ganglia; the presence of spinal cord; and the presence of DRG. In Sec. 318.24(c)(2), if the recovered product derived from any livestock fails under any of these criteria, it cannot be labeled as ``meat.'' In addition, product derived from beef skulls or vertebral column bones from cattle younger than 30 months containing CNS-type tissues cannot be used as an ingredient of a meat food product. For example, this product, if it contained spinal cord, cannot be labeled as ``Beef with Spinal Cord'' or ``Beef with Spinal Cord Meat Food Product'' because detached spinal cord is prohibited from use in the preparation of edible product other than for edible rendering (9 CFR 318.6(b)(4)). It also cannot be labeled as MS(Beef) because FSIS has determined MS(Beef) to be inedible and prohibited its use as human food (see Docket 03-025IF in this issue of the Federal Register. Such product can be rendered to produce products identified as beef stock, beef extract, and beef flavoring without any identification of the source materials other than ``beef'' because the source materials are edible, not inedible. FSIS has determined that it is appropriate to now prohibit product that contains CNS-type tissues derived from cattle younger than 30 months of age for use in a meat food product, except for the sale of brain or the use of brain in which its presence is required to be reflected prominently and conspicuously in labeling. FSIS has established precedent for not allowing detached spinal cord for use in meat food products, but does allow its use for edible rendering. FSIS requests comment on whether product derived from the bones of cattle younger than 30 months (as well as product from livestock other than cattle) that may contain CNS-type tissues should continue to be allowed in edible rendering, or whether such product should be inedible and not allowed in edible rendering or allowed in descriptively labeled meat food product. FSIS requests comment on whether edible rendered products derived from bones of livestock in which the bones may contain CNS-type tissues should be required to bear a common or usual name that reflects the potential presence of CNS- tissue (e.g., ``beef stock derived from materials that may contain spinal cord''). FSIS will be working with FDA on this issue. As discussed above, skulls or vertebral column bones from cattle 30 months of age and older may not be used at all in AMR systems. Product derived from bones of cattle other than skulls or vertebral column bones may bear a name that is not false or misleading but cannot bear the name ``Mechanically Separated (Beef).'' In another interim final rule issued today (see Docket 03-025IF in this issue of [[Page 1883]] the Federal Register), FSIS has determined that MS(Beef) is inedible and prohibited its use as human food. Such product would not contain CNS-type tissues because only the skulls and vertebral column bones contain CNS-type tissues. For purposes of this rule, bone marrow from cattle is not identified as an SRM. The scientific evidence to establish that cattle bone marrow is a tissue that demonstrates infectivity is inconclusive at this time (see Docket No. 03-025IF, also published in this issue of the Federal Register for additional information about bone marrow). Therefore, product from cattle of any age (e.g., through the use of AMR systems using long bones rather than vertebral column bones) that fails to meet the bone marrow standard is misbranded. FSIS seeks comment on this issue. Section 318.24(c)(3) provides that spent skulls and vertebral column bone materials from cattle eligible to enter an AMR system (i.e., from cattle younger than 30 months of age) are eligible for edible rendering, as is the product derived from these bones that contains CNS-type tissues (see Sec. 318.24 (c)(2)(i) or (ii). Although some non-complying AMR product derived from the vertebral column of pork and livestock other than cattle may be diverted to use as MS(Species), such a practice has not been customary in the past because MS(Species) rarely, if ever, is produced in the United States. FSIS is considering rulemaking on MS(Species) from species other than cattle regarding the presence of CNS-type tissue in this product and is seeking comment on this issue. Section 320.1 is amended to extend the recordkeeping requirements to the entire AMR process control system. The current regulation applies only to the calcium criteria. This change is necessary to ensure that establishments maintain appropriate records documenting that they are controlling the entire process, including the appropriate identification and segregation of cattle and their derived products. The establishment may determine to incorporate the control procedures and recordkeeping into their HACCP plan or into their Sanitation SOP or other prerequisite program. Such control procedures may be based on the guidance prepared by the Canadian government for their industry. Request for Comments FSIS requests comments on the measures contained in this interim final rule, and specifically on whether the Agency has chosen measures that are most appropriate for preventing human exposure to the BSE agent in the United States. Emergency Action Given the fact that a cow in Washington State tested positive for BSE on December 23, 2003, it is necessary to issue this rule on an emergency basis. BSE infectivity has been confirmed in the brain, eyes, trigeminal ganglia, tonsils, spinal cord, DRG, and distal ileum. Furthermore, most of these tissues have demonstrated infectivity before experimentally infected animals developed clinical signs of disease. Thus, BSE infectivity in these tissues is not readily ascertainable. Therefore, FSIS has determined that it must take immediate action to ensure that materials that could present a significant risk to human health in beef derived from AMR systems and the spent bone materials derived from AMR systems are excluded from the human food supply. Under these circumstances, the FSIS Administrator has determined that prior notice and opportunity for public comment are contrary to the public interest, and that there is good cause under 5 U.S.C. 553 for making this rule effective less than 30 days after publication in the Federal Register. FSIS will consider comments received during the comment period for this interim rule (see DATES above). After the comment period closes, the Agency will publish another document in the Federal Register. The document will include a discussion of any comments received in response to this interim rule and any amendments made as a result of those comments. In an effort to ensure that establishments comply with this interim final rule upon publication in the Federal Register, FSIS will provide guidance to inspection program personnel regarding the implementation strategy. At a minimum, FSIS inspection program personnel will be directed to meet with management of each affected establishment to discuss how and when the establishment expects to complete its reassessment of its HAACP plan to ensure that SRMs and MS(Beef) do not adulterate product. Executive Order 12866 and the Regulatory Flexibility Act This rule has been reviewed under Executive Order 12866. It has been determined to be economically significant for purposes of E.O. 12866. The emergency situation surrounding this rulemaking makes timely compliance with Executive Order 12866 and the Regulatory Flexibility Act (5. U.S.C. 601 et seq.) impracticable. FSIS is currently assessing the potential economic effects of this action. When this work is complete, the Agency will publish a notice of availability in the Federal Register and will provide an opportunity for public comment. Executive Order 12988 This interim final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts State and local laws and regulations that are inconsistent with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule. However, the administrative procedures specified in 9 CFR 306.5. must be exhausted before any judicial challenge of the application of the provisions of this interim final rule, if the challenge involves any decision of an FSIS employee relating to inspection services provided under the FMIA or PPIA. Paperwork Reduction Act In accordance with section 3507(j) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), the information collection and recordkeeping requirements included in this interim final rule have been submitted for emergency approval to the Office of Management and Budget (OMB). OMB has assigned control number 0583-XXXX to the information and recordkeeping requirements. Title: Advanced Meat Recovery Systems. Type of collection: New. Abstract: FSIS has reviewed the paperwork and recordkeeping requirements in this interim final rule in accordance with the Paperwork Reduction Act. Under this interim final rule, FSIS is requiring a new information collection activity. FSIS is requiring establishments that produce meat from AMR systems to ensure that bones used for AMR systems do not contain brain, trigeminal ganglia, or spinal cord, to test for calcium (at a different level than previously required), iron, protein, spinal cord, and DRG, to document their testing protocols, to assess the age of cattle product used in the AMR system, and to document their procedures for handling product from cattle of any age in a manner that does not cause product to be misbranded or adulterated, and to maintain records of their documentation and test results. Estimate of burden: FSIS estimates that it will take establishments on a daily basis 30 minutes to collect the [[Page 1884]] information such as for calcium and iron and 30 minutes to sample for spinal cord and DRG. The Agency estimates that it will take 2 minutes to do recordkeeping of test results. FSIS also estimates that it will take establishments 2 hours to develop their testing protocols. Respondents: Establishments that produce livestock product (e.g., beef and pork) from AMR systems. Estimated Number of Respondents: 56. Estimated Number of Responses per Respondent: 1,201. Estimated Total Annual Burden on Respondents: 18,088 hours. Copies of this information collection assessment can be obtained from John O'Connell, Paperwork Reduction Act Coordinator, FSIS, USDA, 112 Annex, 300 12th Street, SW., Washington, DC 20250-3700. Additional Public Notification Public involvement in all segments of rulemaking and policy development is important. Consequently, in an effort to better ensure that minorities, women, and persons with disabilities are aware of this interim final rule and informed about the mechanism for providing their comments, FSIS will announce it and make copies of this Federal Register publication through the FSIS Constituent Update, which is communicated via Listserv, a free e-mail subscription service. In addition, the update is available online through the FSIS web page located at http://www.fsis.usda.gov. The update is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, recalls, and any other types of information that could affect or would be of interest to our constituents and stakeholders. The constituent Listserv consists of industry, trade, and farm groups, consumer interest groups, allied health professionals, scientific professionals, and other persons who have requested to be included. Through the Listserv and web page, FSIS is able to provide information to a much broader, more diverse audience. For more information, contact the Congressional and Public Affairs Office, at (202) 720-9113. To be added to the free e-mail subscription service (Listserv) go to the ``Constituent Update'' page on the FSIS Web site at http://www.fsis.usda.gov/oa/update.htm. Click on the ``Subscribe to the Constituent Update Listserv'' link, then fill out and submit the form. Footnotes The following sources are referred to in this document and are available for review in the FSIS Docket Room (See ADDRESSES above) between 8:30 a.m. and 4 p.m., Monday through Friday. 1. Harvard Center for Risk Analysis, Harvard School of Public Health, and Center for Computations Epidemiology, College of Veterinary Medicine, Tuskegee University, November 2001. Evaluation of the Potential for Bovine Spongiform Encephalopathy in the United States. 2. Summary of Calendar Year 2003 AMR Testing, FSIS. 3. Hasiak, R.J. and H. Marks, The ``Advanced Meat Recovery System'' Survey Project Final Report, February 21, 1997. 4. FSIS Directive 7160.2, ``Meat'' Prepared Using Advanced Mechanical Meat/Bone Separation Machinery and Meat Recovery Systems, April 14, 1997. 5. FSIS technical paper, Derivation of excess iron limits for meat products produced by Advanced Recovery Systems, July 21, 1999. 6. Wyndom, W.R. and R.A. Field, Effect of method of analysis on iron content of beef from advanced meat recovery systems, May 2000. 7. Georgetown University Center for Food & Nutritional Policy, Advanced Meat Recovery Systems, 1999. 8. Sparks Companies, Inc., Advanced Meat Recovery Systems--An Economic Analysis of Proposed USDA Regulations, July 1999. 9. Letter to FDA and USDA, submitted by Public Citizen, and signed by the Animal Welfare Institute. Cancer Prevention Coalition, Center for Food Safety, Community Nutrition Institute, Family Farm Defenders, Farm Sanctuary, Global Resource Action Center for the Environment, Government Accountability Project, Project Humane Farming Association, Institute for Agriculture and Trade Policy, National Family Farm Coalition, Organic Consumers Association, Public Citizen, and the U.S. Public Interest Research Group, April 13, 2001. 10. Petition for Regulatory Action to Bar the Use of Spinal Cord and Columns and Other Potentially Infectious Tissue from Beef in the Human Food Supply, submitted by the Center for Science in the Public Interest, on behalf of the American Public Health Association, Consumer Federation of America, Government Accountability Project, National Consumers League, and Safe Tables Our Priority, August 9, 2001. 11. Analysis of 2002 FSIS Bovine AMR Survey Results, prepared by the USDA, FSIS, February 2003. 12. FSIS Directive 7160.3, Revision 1, Advanced Meat Recovery Using Beef Vertebral Raw Materials, August 25, 2003. List of Subjects 9 CFR Part 301 Meat and meat products. 9 CFR Part 318 Meat inspection, Records. 9 CFR Part 320 Meat inspection, Records. 0 For the reasons set forth above, FSIS is amending 9 CFR, chapter III, as follows: PART 301--TERMINOLOGY 0 1. The authority citation for part 301 continues to read as follows: Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR 2.18, 2.53. 0 2. In Sec. 301.2, the definition of ``Meat'' is revised to read as follows: Sec. 301.2 Definitions. * * * * * Meat. (1) The part of the muscle of any cattle, sheep, swine, or goats which is skeletal or which is found in the tongue, diaphragm, heart, or esophagus, with or without the accompanying and overlying fat, and the portions of bone (in bone-in product such as T-bone or porterhouse steak), skin, sinew, nerve, and blood vessels which normally accompany the muscle tissue and that are not separated from it in the process of dressing. As applied to products of equines, this term has a comparable meaning. (i) Meat does not include the muscle found in the lips, snout, or ears. (ii) Meat may not include significant portions of bone, including hard bone and related components, such as bone marrow, or any amount of brain, trigeminal ganglia, spinal cord, or dorsal root ganglia (DRG). * * * * * PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS 0 3. The authority citation for part 318 continues to read as follows: Authority: 7 U.S.C. 138f, 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR 2.7, 2.18, and 2.53. 0 4. Section 318.24 is revised to read as follows: Sec. 318.24 Product prepared using advanced meat/bone separation machinery; process control. (a) General. Meat, as defined in Sec. 301.2 of this subchapter, may be derived by mechanically separating skeletal muscle tissue from the bones of livestock, other than skulls or vertebral column bones of cattle 30 months of age and older as provided in Sec. 310.22 of this subchapter, using advances in mechanical meat/bone separation machinery (i.e., AMR systems) that, in accordance with this section, recover meat-- (1) Without significant incorporation of bone solids or bone marrow as measured by the presence of calcium and iron in excess of the requirements in this section, and (2) Without the presence of any brain, trigeminal ganglia, spinal cord, or dorsal root ganglia (DRG). [[Page 1885]] (b) Process control. As a prerequisite to labeling or using product as meat derived by the mechanical separation of skeletal muscle tissue from livestock bones, the operator of an establishment must develop, implement, and maintain procedures that ensure that the establishment's production process is in control. (1) The production process is not in control if the skulls entering the AMR system contain any brain or trigeminal ganglia tissue, if the vertebral column bones entering the AMR system contain any spinal cord, if the recovered product fails otherwise under any provision of paragraph (c)(1), if the product is not properly labeled under the provisions of paragraph (c)(2), or if the spent bone materials are not properly handled under the provisions of paragraph (c)(3) of this section. (2) The establishment must document its production process controls in writing. The program must be designed to ensure the on-going effectiveness of the process controls. If the establishment processes cattle, the program must be in its HACCP plan, its Sanitation SOP, or other prerequisite program. The program shall describe the on-going verification activities that will be performed, including the observation of the bones entering the AMR system for brain, trigeminal ganglia, and spinal cord; the testing of the product exiting the AMR system for bone solids, bone marrow, spinal cord, and DRG as prescribed in paragraph (c)(1) of this section; the use of the product and spent bone materials exiting the AMR system; and the frequency with which these activities will be performed. (3) The establishment shall maintain records on a daily basis sufficient to document the implementation and verification of its production process. (4) The establishment shall make available to inspection program personnel the documentation described in paragraphs (b)(2) and (b)(3) of this section and any other data generated using these procedures. (c) Noncomplying product. (1) Notwithstanding any other provision of this section, product that is recovered using advanced meat/bone separation machinery is not meat under any one or more of the following circumstances: (i) Bone solids. The product's calcium content, measured by individual samples and rounded to the nearest 10th, is more than 130.0 mg per 100 g. (ii) Bone marrow. The product's added iron content, measured by duplicate analyses on individual samples and rounded to the nearest 10th, is more than 3.5 mg per 100 g.\1\ --------------------------------------------------------------------------- \1\ The excessive iron (ExcFe) measurement for an analyzed sample is equal to the obtained iron (Fe) result expressed in mg/100 g measured and rounded to the nearest 100th or more for that sample, minus the product of three factors: (1) The iron to protein ratio (IPR) factor associated with corresponding hand-deboned product; (2) the obtained protein (P) result (%) for that sample; and (3) a constant factor of 1.10. In formula, this can be written as: ExcFe = mFe - IPR x Protein x 1.10, where ExcFe represents the excess iron, expressed in units of mg/100 g; mFe represents the measured level of iron (Fe, mg/100 g), IPR is the iron to protein ratio for the appropriate hand-deboned product, and ``Protein'' is the measured level of protein rounded to the nearest 100th and expressed as a percentage of the total weight of the sample. In lieu of data demonstrating otherwise, the values of IPR to be used in the above formula are as follows: For beef products the value of IPR is equal to 0.104, except for any combination of bones that include any beef neckbone product, for which the value of 0.138 is to be used; for pork product, the IPR value is 0.052. Other IPR values can be used provided that the operator of an establishment has verified and documented the ratio of iron content to protein content in the skeletal muscle tissue attached to bones prior to their entering the AMR system, based on analyses of hand-deboned samples, and the documented value is to be substituted for the IPR value (as applicable) in the above formula with respect to product that the establishment mechanically separates from those bones. --------------------------------------------------------------------------- (iii) Brain or trigeminal ganglia. Skulls that enter the AMR system have tissues of brain or trigeminal ganglia. (iv) Spinal cord. Vertebral column bones that enter the AMR system have tissues of spinal cord, or the product that exits the AMR system contains spinal cord. (v) DRG. The product that exits the AMR system contains DRG. (2) If product that may not be labeled or used as ``meat'' under this section meets the requirements of Sec. 319.5 of this subchapter, it may bear the name ``Mechanically Separated (Species)'' except as follows: (i) If skulls or vertebral column bones of cattle younger than 30 months of age that enter the AMR system have tissues of brain, trigeminal ganglia, or spinal cord, the product that exits the AMR system shall not be used as an ingredient of a meat food product. (ii) If product that exits the AMR system contains spinal cord or DRG from bones of cattle younger than 30 months of age, it shall not be used as an ingredient of a meat food product. (iii) If product derived from any bones of cattle of any age does not comply with (c)(1)(i) or (ii), it may bear a common or usual name that is not false or misleading, except that the product may not bear the name ``Mechanically Separated (Beef).'' (3) Spent skulls or vertebral column bone materials from cattle younger than 30 months of age that exit the AMR system shall not be used as an ingredient of a meat food product. PART 320--RECORDS, REGISTRATION AND REPORTING 0 5. The authority citation for part 320 continues to read as follows: Authority: 21 U.S.C. 601-695; 7 CFR 2.7, 2.18, and 2.53. Sec. 320.1 [Amended] 0 6. Section 320.1, paragraph (b)(10), is amended by removing ``of calcium content in meat derived from'' and adding, in its place, ``documenting the development, implementation, and maintenance of procedures for the control of the production process using.'' Done in Washington, DC, on: January 7, 2004. Garry L. McKee, Administrator. [FR Doc. 04-626 Filed 1-8-04; 1:43 pm] ----------------------------------------------------------------------- [Federal Register: January 12, 2004 (Volume 69, Number 7)] [Rules and Regulations] [Page 1861-1874] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr12ja04-25] [[Page 1861]] ----------------------------------------------------------------------- Part V Department of Agriculture ----------------------------------------------------------------------- Food Safety and Inspection Service ----------------------------------------------------------------------- 9 CFR Part 301, 309, et al. Prohibition of the Use of Specified Risk Materials for Human Food and Requirements for the Disposition of Non-Ambulatory Disabled Cattle; Meat Produced by Advanced Meat/Bone Separation Machinery and Meat Recovery (AMR) Systems; Prohibition of the Use of Certain Stunning Devices Used To Immobilize Cattle During Slaughter; Bovine Spongiform Encephalopathy Surveillance Program; Interim Final Rules and Notice [[Page 1862]] ----------------------------------------------------------------------- DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service 9 CFR Parts 309, 310, 311, 318, and 319 [Docket No. 03-025IF] Prohibition of the Use of Specified Risk Materials for Human Food and Requirements for the Disposition of Non-Ambulatory Disabled Cattle AGENCY: Food Safety and Inspection Service, USDA. ACTION: Interim final rule and request for comments. ----------------------------------------------------------------------- SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the Federal meat inspection regulations to designate the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia (DRG) of cattle 30 months of age and older, and the tonsils and distal ileum of the small intestine of all cattle, as ``specified risk materials'' (SRMs). The Agency is declaring that SRMs are inedible and prohibiting their use for human food. In addition, FSIS is requiring that all non-ambulatory disabled cattle presented for slaughter be condemned. The Agency is requiring that federally-inspected establishments that slaughter cattle and federally-inspected establishments that process the carcasses or parts of cattle develop, implement, and maintain written procedures for the removal, segregation, and disposition of SRMs. Establishments must incorporate these procedures into their HACCP plans or in their Sanitation SOPs or other prerequisite program. FSIS is taking this action in response to the diagnosis on December 23, 2003, by the U.S. Department of Agriculture of a positive case of bovine spongiform encephalopathy (BSE) in an adult Holstein cow in the State of Washington. This action will minimize human exposure to materials that scientific studies have demonstrated as containing the BSE agent in cattle infected with the disease. Infectivity has never been demonstrated in the muscle tissue of cattle experimentally or naturally infected with BSE at any stage of the disease. DATES: This interim final rule is effective January 12, 2004. Comments on this interim final rule must be received by April 12, 2004. ADDRESSES: Submit written comments to: FSIS Docket Clerk, Docket 03-025IF, Room 102, Cotton Annex, 300 12th and C Street, SW., Washington, DC 20250-3700. Reference materials cited in this document and any comments received will be available for public inspection in the FSIS Docket Room from 8:30 a.m. to 4:30 p.m., Monday through Friday. Reference materials that are not copyrighted will also be available on the FSIS Web site at http: //http://www.fsis.usda.gov. FOR FURTHER INFORMATION CONTACT: Daniel L. Engeljohn, Ph.D., Executive Associate, Policy Analysis and Formulation, Office of Policy and Program Development, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250-3700; (202)205-0495. SUPPLEMENTARY INFORMATION: Background Under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.), FSIS issues regulations governing the production of meat and meat food products prepared for distribution in commerce. The regulations, along with FSIS inspection programs, are designed to ensure that meat and meat food products are safe, wholesome, unadulterated, and properly marked, labeled, and packaged. The FMIA prohibits anyone from selling, transporting, offering for sale or transportation, or receiving for transportation in commerce, any adulterated or misbranded meat or meat food product (21 U.S.C. 610). Under the FMIA, a meat food product is adulterated if, among other circumstances, it bears or contains any poisonous or deleterious substance that may render it injurious to health (21 U.S.C. 601(m)(1)) or if it is for any reason unsound, unhealthful, unwholesome, or unfit for human food (21 U.S.C. 601(m)(3)). The FMIA requires that FSIS inspect the carcasses, parts of carcasses, and meat food products of all cattle, sheep, swine, goats, horses, mules, or other equines that are capable for use as human food to ensure that such articles are not adulterated (21 U.S.C. 604, 606). If the carcasses, parts of carcasses, and meat food products are found, upon inspection, to be not adulterated, FSIS marks them as ``Inspected and passed'' (21 U.S.C. 604, 606, 607). The FMIA gives FSIS broad authority to promulgate such rules and regulations as are necessary to carry out the provisions of the Act (21 U.S.C. 621). As discussed in greater detail below, infectivity has been confirmed in the brain, trigeminal ganglia, tonsils, spinal cord, DRG, and distal ileum of the small intestine of cattle experimentally infected with BSE, and in the brain, spinal cord, and eyes of cattle infected with BSE under field conditions. Data on the age distribution of clinical cases of BSE in the field reported in the United Kingdom indicate that clinical BSE disease has rarely been reported in cattle younger than 30 months of age. In cattle experimentally infected with BSE, infectivity has been confirmed in the distal ileum at various stages of the disease process and as early as 6 months after oral exposure to the BSE agent. The tonsils of experimentally infected cattle have demonstrated apparently weak infectivity as early as 10 months after oral exposure to the BSE agent. The other tissues in which BSE infectivity has been confirmed have demonstrated infectivity at the end stages of disease, which, in experimentally infected cattle, was 32 months after exposure to the BSE agent and later. The brain, trigeminal ganglia, tonsils, DRG, and distal ileum are materials of experimentally infected cattle in which infectivity has been confirmed before the onset of clinical disease. Based on these findings, FSIS has concluded that the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and DRG of cattle 30 months of age and older, and the tonsils and distal ileum of the small intestine of all cattle are unfit for human food under section 1(m)(3) of the FMIA (21 U.S.C 601(m)(3)). Therefore, FSIS is designating these materials as SRMs, declaring that they are inedible and, pursuant to its authority to promulgate regulations necessary to carry out the provisions of the FMIA, prohibiting their use for human food. Because there are currently no restrictions on the incorporation of spinal cord and DRG into MS(Beef) meat food product, such product may contain concentrated amounts of these high-risk tissues. Therefore FSIS has concluded that, like the SRMs described above, MS(Beef) is unfit for human food under section 1(m)(3) of the FMIA (21 U.S.C. 601(m)(3)). As discussed in detail below, surveillance data from European countries in which BSE has been detected indicate that non-ambulatory cattle are among the animals that have a greater incidence of BSE than other cattle. Surveillance data also indicate that clinical signs of BSE cannot always be observed in non-ambulatory cattle. Furthermore, due to limitations in the testing methods for BSE that are available today, certain tissues of cattle [[Page 1863]] infected with BSE may contain BSE infectivity even though the diagnostic test does not indicate that the animal has the disease. For the reasons presented above, FSIS believes that non-ambulatory disabled cattle present a risk of introducing the BSE agent into the human food supply. Therefore, FSIS has determined that the carcasses of non- ambulatory disabled cattle are unfit for human food under section 1(m)(3) of the FMIA and that all non-ambulatory disabled cattle that are presented for slaughter should be condemned. By declaring SRMs and MS(Beef) inedible and prohibiting their use for human food, and by condemning all non-ambulatory disabled cattle, FSIS will ensure that materials that could present a significant risk to human health, but whose infectivity status cannot be readily ascertained, are excluded from the human food supply. Because BSE was recently confirmed in a cow in the United States, FSIS has determined that the SRMs identified in this document are unfit for human food. Thus, the status of most of these materials has changed from edible to inedible. Such a change is likely to affect the underlying hazard analysis that must be conducted as prescribed by 9 CFR 417.4(a)(3). Therefore, in response to this change, FSIS expects that establishments that slaughter cattle and establishments that process the carcasses or parts of cattle will reassess their HACCP plans in accordance with 9 CFR 417.4(a)(3) to address SRMs. BSE and Variant Creutzfeldt-Jakob Disease BSE is a progressive degenerative disease that affects the central nervous system (CNS) of adult cattle. BSE belongs to the family of diseases known as transmissible spongiform encephalopathies (TSEs), which include, among other diseases, scrapie in sheep and goats, chronic wasting disease (CWD) in deer and elk, and Cruetzfeldt-Jakob disease (CJD) in humans. The typical incubation period (the time from when an animal becomes infected until it first shows disease signs) for BSE is believed to be from two to eight years. BSE was first documented in the United Kingdom in 1986 and has since been identified in approximately 21 other countries in Europe. BSE has also been confirmed in some non-European countries, including Japan, Israel, and Canada. On December 23, 2003, USDA announced a presumptive diagnosis of BSE in an adult Holstein cow from Washington State. Samples were taken from the cow on December 9 as part of USDA's BSE surveillance program. The BSE diagnosis was made on December 22 and 23 by histopathology and immunohistochemical testing at the National Veterinary Services Laboratory, Ames, Iowa. On December 25, 2003, the International Reference Laboratory in Weybridge, England confirmed the diagnosis of BSE. The agent that causes BSE and other TSEs has yet to be fully characterized. The theory that is most accepted in the scientific community is that the agent is a prion, which is an abnormal form of a normal protein known as cellular prion protein, although other types of agents have also been implicated. The agent is highly resistant to heat, ultraviolet light, ionizing radiation, and common disinfectants that normally inactivate viruses or bacteria. In 1996, a newly recognized form of the human disease CJD, referred to as vCJD, was reported in the United Kingdom. Scientific and epidemiological studies have linked vCJD to exposure to BSE, probably through human consumption of beef products contaminated with the agent that causes BSE (Ref. 1-5 available for viewing by the public in the FSIS Docket Room). To date, approximately 150 probable and confirmed cases of vCJD have been reported worldwide. The Centers for Disease Control and Prevention (CDC) leads a surveillance system for vCJD in the United States, and as of December, 2003, the disease has never been detected in residents of the United States that have never lived in or traveled to the United Kingdom for extended periods of time. In 2002, a probable case of vCJD was reported in a Florida resident who lived in the United Kingdom during the BSE epidemic. Epidemiological data indicate that the patient was likely exposed to the BSE agent before moving to the United States. (Ref. 6 available for viewing by the public in the FSIS Docket Room). The United States government has implemented a number of measures to prevent BSE from entering the United States and to prevent the spread of the disease should it be introduced into the United States. Since 1989, USDA's Animal and Plant Health Inspection Service (APHIS) has prohibited the importation of live cattle and certain cattle products, including rendered protein products, from countries where BSE is known to exist. In 1997, due to concerns about widespread risk factors and inadequate surveillance for BSE in many European countries, these importation restrictions were extended to include all of the countries in Europe. In 1997, FDA prohibited the use of most mammalian protein in the manufacture of animal feeds given to cattle and other ruminants. In December 2000, APHIS prohibited all imports of rendered animal protein products, regardless of species, from BSE-restricted countries because of concern that feed intended for cattle may have been cross-contaminated with the BSE agent. In addition, APHIS leads an ongoing, comprehensive, interagency surveillance system for BSE in the United States and, in cooperation with FSIS, has drafted an emergency response plan to be used in the event that BSE is identified in the United States. This plan was activated when the BSE test for the cow in Washington State came back presumptive positive on December 23, 2003. Other Federal agencies also have contingency plans that work in concert with the USDA plan. BSE Infectivity Animal age. The distribution and amount of the BSE agent in cattle infected with BSE is not known with certainty. It is generally accepted that in animals with clinical BSE disease, the brain and spinal cord contain the greatest concentration of the BSE agent, and that the quantity of the agent increases as the animals progress through the incubation period to the development of clinical disease. Thus, the total infective load in cattle in the early stages of the incubation period is believed to be much lower than in cattle approaching the end of the incubation period or in those cattle with overt clinical BSE. As stated above, the typical incubation period for BSE is believed to be between two to eight years. Information on the age at which cattle develop clinical BSE under field conditions, i.e., commercially reared cattle not part of a specially designed experiment, can be useful in identifying those cattle that, if infected with the BSE agent, are most likely to contain the highest levels of infectivity. Age-of-onset was known and recorded for approximately 135,000 cattle with confirmed clinical BSE in the United Kingdom between 1988 and August 2003 (Ref. 7, available for viewing by the public in the FSIS Docket Room). These data demonstrate that the age at which cattle develop clinical disease varies. The data from the United Kingdom show a gradual increase in the number of clinical BSE cases with increasing age, and that the number of confirmed cases peaks at 5 years of age. The lower ranges of this age distribution include some cattle younger than 30 months of age. [[Page 1864]] The age distribution data show that, of the cattle that developed clinical BSE in the field, only 0.01% were less than 30 months of age. Thus, cattle younger than 30 months of age are less likely to be in the later stages of BSE incubation than older BSE-infected cattle, and hence, are less likely to contain high levels of BSE infectivity. Research demonstrates that the incubation period for BSE appears to be linked to the infectious dose of the BSE agent received, i.e., the larger the infectious dose received the shorter the incubation period (Ref. 8, available for viewing by the public in the FSIS docket room). Thus, given these observations, scientists that have studied the disease believe that the occurrence of BSE in young cattle is most likely the result of exposure to a very large dose of the BSE agent at a very young age. Detection of BSE in cattle younger than 30 months of age. In October 2003, Japan reported a BSE case in a 23-month old bull, the 8th BSE case confirmed in that country. Earlier cases confirmed in Japan were in cattle over 5 years of age. This recent case apparently did not have clinical signs of disease and was detected as part of Japan's regular surveillance for BSE in which all cattle slaughtered for human consumption are screened for the disease. In reporting on this BSE case, Japanese officials stated that tests suggested that the form of the BSE agent found in the affected animal was atypical, and that they planned to conduct further studies on this form of the disease. A similar form of the atypical agent detected in the Japanese animal has been reported in two BSE cases in Italy. However the Italian animals were 11 and 12 years old. Japan has reported importing feed from Italy. In early November 2003, shortly after reporting the confirmation of BSE in a 23-month-old animal, Japan reported that BSE was confirmed in a 21-month-old animal. The 21-month-old animal is Japan's 9th reported case of BSE. Like the 23-month-old animal, this animal apparently did not have clinical signs of disease. However, the abnormal prion protein detected in this animal does not appear to be the same as the apparently atypical form detected in the 23-month-old animal. Japanese officials reported that they will be conducting testing to determine if the tissues of these relatively young cattle that were recently found positive for BSE contain BSE infectivity. The immediate implications of the recent detection of BSE in two animals younger than 24 months of age in Japan, one of which has an apparently atypical form of the disease, are not readily apparent at this time. Although rare, confirmed cases of BSE in animals younger than 30 months of age have also been reported in the United Kingdom and in some other European countries. As stated earlier in this document, a confirmed case of BSE in an animal less than 30 months of age generally implies that the animal was exposed to a large dose of the infective agent at a young age. From 1988 to 1996, during the height of the BSE epidemic in the United Kingdom when large amounts of infective agent were being circulated among cattle herds, 19 clinical cases of BSE were confirmed in cattle younger than 30 months of age (Ref. 9, available for viewing by the public in the FSIS docket room). The youngest confirmed case of BSE was in the United Kingdom in an animal with clinical disease at 20 months of age in 1992. However, as of September 30, 2003, no cases of BSE in cattle younger than 30 months of age have been detected in the United Kingdom since 1996, and only 3 cases have been found in European animals less than 30 months of age since 2001. FSIS requests comment on the potential implications, if any, of the reported 21- and 23-month-old cases of BSE in Japan. The Agency is also requesting comments on whether, and if so how, it should modify the measures in this rulemaking to address the fact that, in rare instances, BSE has been confirmed in cattle younger than 30 months of age. Infective tissues. Available data on the development and distribution of tissue infectivity in BSE-infected cattle are incomplete. Most of what is known comes from pathogenesis studies conducted in the United Kingdom (Ref. 10, 11, 12 available for viewing by the public in the FSIS Docket Room). In these studies, cattle were deliberately infected with BSE through oral exposure to the brains of cattle with confirmed BSE. The experimentally infected cattle were killed at regular intervals as the disease developed, and at each interval the tissues of the infected cattle were examined for histopathological changes consistent with BSE and for abnormal prion proteins. At each interval, tissues of the BSE infected cattle were also injected into mice to identify those tissues of cattle capable of transmitting the disease. The pathogenesis studies involved a small number of cattle (30 animals) that received a large, uniform dose of the BSE agent at a very young age (4 months). Thus, the findings may not reflect the development and distribution of infectivity of cattle exposed to the BSE under field conditions, where the level and age of exposure to the BSE agent are unpredictable. Furthermore, the pathogenesis studies did not determine the rate at which the BSE agent increases in the tissues that have demonstrated infectivity or the tissues that the agent must pass through to reach its ultimate destination in the animal after it is ingested. However, the results of these studies are useful in that they provide experimental evidence of the distribution of the infective agent in BSE-infected cattle at various stages of the disease. The pathogenesis studies demonstrate that in cattle infected with BSE, the total amount of infectivity in the animal, as well as the distribution of infectivity in the animal's body, change over time, with the highest levels of infectivity detected in the brain and spinal cord at the end stages of disease. In the studies, some cattle exhibited clinical signs of BSE as early as 35 months post oral exposure to the BSE agent. By 37 months post oral exposure, all of the 5 animals that were still alive demonstrated clinical evidence of BSE (animals had been serially sacrificed at set intervals). In cattle with clinical BSE, infectivity was demonstrated in the brain, spinal cord, DRG, trigeminal ganglia, and the distal ileum of the small intestine. (DRG are clusters of nerve cells attached to the spinal cord that are contained within the bones of the vertebral column. ``DRG'' as used in this document has the same meaning as the term ``dorsal spinal nerve root ganglia.'' Trigeminal ganglia are clusters of nerve cells connected to the brain that lie close to the exterior of the skull.) In one set of animals, infectivity was demonstrated in the bone marrow at 38 months post exposure, but these findings were not conclusive. At this time, bone marrow is not designated as SRM. However, in today's Federal Register, FSIS is announcing new requirements to limit the presence of bone marrow in meat produced from AMR systems, with iron as a marker. This action is not a food safety measure at this time but is related to misbranding. In some cattle in the studies, BSE infectivity was demonstrated in the brain, spinal cord, and DRG as early as 32 months post oral exposure to the BSE agent. In addition, infectivity was demonstrated in these tissues three months before animals began to develop clinical signs of the disease. Infectivity was demonstrated in the distal ileum of cattle 6 to 18 months post oral exposure to the BSE agent and again at 38 months and 40 months post oral exposure. A second phase of the pathogenesis studies that uses a cattle bioassay is being conducted to ensure that low levels of infectivity that may not have [[Page 1865]] been detected in the first phase using the mouse bioassay are not missed. The cattle bioassay, in which tissues from cattle deliberately infected with BSE are injected directly into the brains of BSE-free cattle, is considered to be several hundred-fold more sensitive in detecting BSE infectivity than the mouse bioassay. Preliminary results from the cattle bioassay demonstrate that, in addition to the materials that were found to contain infectivity when the mouse bioassay was used, the tonsils of calves 10 months post oral exposure to the BSE agent contain infectivity. However, because only one of five animals injected with infected tonsil material developed clinical BSE at 45 months post-inoculation, the level of infectivity in the tonsils appears to be very low. The second phase of the study is still underway and is not expected to be completed for several more years. (Ref. 8 and 13, available for viewing by the public in the FSIS Docket Room). In cattle infected with BSE under field conditions, BSE infectivity has been confirmed in the brain, spinal cord, and retina of the eye at the end stages of the disease (Ref. 8 available for viewing by the public in the FSIS Docket Room). BSE infectivity has never been demonstrated in the muscle tissue of cattle experimentally or naturally infected with the disease at any stage of the disease. Proportion of infectivity in certain tissues. In 2001, the European Commission's Scientific Steering Committee (SSC), a scientific advisory committee for the European Union, considered the amount and distribution of BSE infectivity in a typical case of BSE and estimated that, in an animal with clinical disease, the brain contains 64.1% of the total infectivity in the animal and the spinal cord contains 25.6% of the total infectivity (Ref. 14 available for viewing by the public in the FSIS Docket Room). Thus, the brain and spinal cord of cattle with clinical BSE are estimated to contain nearly 90% of the total infectivity in the animal. According to the SSC, the remaining proportion of infectivity in a typical animal with clinical BSE is found in the DRG (3.8%), the trigeminal ganglia (2.6%), the distal ileum (3.3%), the spleen (0.3%), and the eyes (0.04%).\1\ However, as mentioned above, in experimentally infected cattle BSE infectivity has been demonstrated in the distal ileum as early as 6 to 18 months post oral exposure to the BSE agent and in the tonsils as early as 10 months post exposure. Thus, in younger cattle infected with BSE, these materials apparently present the greatest risk of exposing humans to the BSE agent. --------------------------------------------------------------------------- \1\ For this study, low levels of infectivity were assumed for the spleen and eyes based on scrapie experiments. The spleen has not demonstrated infectivity in cattle. --------------------------------------------------------------------------- Current Regulatory Requirements for Potentially Infective Materials Under FSIS' regulations, most of the materials that have demonstrated BSE infectivity in cattle with clinical disease, i.e., brain, eyes, trigeminal ganglia, spinal cord, DRG, and the distal ileum of the small intestine, may currently be used in some way for human food. The brains of all livestock species, including the brains of cattle, are permitted for human food, with the exception of brains from animals stunned by lead, sponge iron, or frangible bullets (9 CFR 310.18(b)). Unprocessed cattle brains are typically sold chilled, frozen, or canned, and are consumed as a variety meat. Cattle brains may also be used as a by-product ingredient in certain processed products. When used as a by-product ingredient, cattle brains must be listed in the ingredients statement on the labeling of the product and declared by species (9 CFR 317.2(f)(1)). Cattle brains are also permitted to be used as a source material in edible rendering. Edible rendering involves the processing of materials inspected and passed for human food into products, such as edible oils, meals, beef extracts, beef protein, beef broths, beef stocks, and beef flavorings. Many of these products are regulated by FSIS and FDA. Given the invariable presence of bone splinters, detached spinal cords from all livestock species, including cattle, are prohibited for use in the preparation of edible products (9 CFR 318.6(b)(4)). However, detached spinal cords may be used as a raw material in edible rendering (9 CFR 318.6(b)(4)). The labeling of extracts prepared from brains, spinal cords, or other organs or parts of the carcass other than fresh meat from all livestock species, including cattle, must include the true name of the parts from which the product was prepared, e.g., ``extract from beef brain'' (9 CFR 317.8(b)(15)). Vertebral columns from cattle contain both spinal cord and DRG. FSIS' regulations do not require that the spinal cord or DRG of cattle be removed from the vertebral column at the time of slaughter. Thus, some bone-in beef products may contain spinal cord, DRG, or both. Bones from the vertebral column of cattle are permitted to be used as source materials in the production of processed products manufactured from edible rendering. When the vertebral columns from cattle are used in the production of such products, spinal cord and DRG that remain attached to the vertebral column could potentially become dislodged and incorporated into the final product. Under the FSIS regulations, the labeling of the final product is not required to disclose the fact that the product may contain spinal cord or DRG. Bones from the vertebral column of cattle are also permitted for use as a source material in meat recovery systems that use pressure to separate beef muscle tissue from bones. When the vertebral columns are used as a source material in these systems, spinal cord and DRG may become dislodged from the vertebral bones and incorporated into the final product. The use of vertebral columns in systems that mechanically separate meat and meat products from bone, and the labeling requirements for such products, are discussed in greater detail below. Casings made from the small intestine, including the distal ileum, of cattle are permitted to be used as containers for meat food products (9 CFR 318.6(b)(1)). Cattle intestines, including the distal ileum, are also permitted for use as ingredients in meat food products that do not have an FSIS prescribed standard of identity, provided that the products are properly labeled (9 CFR 318.6(b)(8)). FSIS' regulations do not prohibit the use of cattle eyes for human food, although direct consumption of such materials is uncommon in the United States. The tonsils of all livestock species, including cattle, are prohibited for use as ingredients of meat food products (9 CFR 318.6(b)(6)). The trigeminal ganglia of cattle are not sold directly as consumer products. However, the heads of cattle (commonly referred to as ``market heads'') are permitted for use as human food and are sold to retail establishments where they are used to produce edible products. Some retail establishments sell market heads of cattle directly to consumers. Cattle market heads contain skull, eyes, trigeminal ganglia, and fragments of brains. Meat that has been trimmed from the head and cheeks of cattle is permitted to be used in FSIS-regulated products, although some product standards place certain restrictions on the use of head and cheek meat (for examples see 9 CFR 319.81, 9 CFR 319.199, 9 CFR 319.300 9 CFR 319.301, and 9 CFR.303) Head or cheek meat may contain CNS materials if the meat is not removed before the skull is fragmented or split. Although rare, the skulls of cattle are sometimes [[Page 1866]] intentionally split to remove materials contained within the cranial cavity, such as the pituitary gland. The skulls of cattle are sometimes unintentionally fragmented, and the brains of the animals exposed, when a mechanical device is used to remove horns from cattle. In some instances, in addition to the fragmentation that occurs during horn removal, the brain has also been penetrated by the captive bolt of a stun gun, which results in a hole with weeping material that may contain CNS tissue. In these cases, when the head and cheek meat are removed, the heads of the cattle may be manipulated in such a way as to potentially contaminate the meat. Contamination of head or cheek meat with trigeminal ganglia is unlikely because the trigeminal ganglia are embedded within the skull and are not likely to be removed when the meat is harvested. Meat Produced Using Advanced Meat Recovery Systems and Mechanically Separated (Species) Meat Food Product Advanced Meat Recovery. Advanced Meat Recovery (AMR) is a technology that enables processors to remove the attached skeletal muscle tissue from livestock bones without incorporating significant amounts of bone and bone products into the final meat product. When produced properly, product from AMR systems is comparable to meat derived by hand deboning and can be labeled as ``meat'' (9 CFR 301.2). Under the FSIS regulations, spinal cord is not a component of meat, and therefore, product from AMR systems identified as ``meat'' that contains spinal cord is misbranded. From January through August 2002, FSIS conducted a survey of AMR products derived from the vertebral column of cattle to establish a baseline for the prevalence of spinal cord and DRG tissue in beef AMR products (referred to as the 2002 Beef AMR Survey) (Ref. 15 and 16, available for viewing by the public in the FSIS docket room and on the Internet at http://www.fsis.usda.gov/oa/topics/AMRAnalysis.pdf and http://www.fsis.usda.gov/OA/topics/AMRSurvey.pdf). In the 2002 Beef AMR Survey, the Agency found that while some establishments were able to consistently produce beef AMR product that was free of spinal cord and DRG tissue, a majority of the establishments had difficulty keeping spinal cord and DRG out of their AMR products. Overall, FSIS found that that approximately 76% (25 of 34) of the establishments whose AMR product was tested had positive laboratory results for spinal cord, DRG, or both in their final beef AMR products. The survey also found that approximately 35% (89 of 256) of all final AMR product samples that were tested had positive laboratory results for spinal cord, DRG, or both. In March 2003, after completion of the 2002 Beef AMR Survey, FSIS implemented a routine regulatory sampling program of beef products from AMR systems as an additional measure to prevent misbranding of beef AMR products. Prior to the implementation of this regulatory sampling program, FSIS inspection program personnel collected AMR product samples for analysis for the presence of spinal cord tissue only if they believed that the establishment was not completely removing spinal cord from the vertebral column before the vertebral bones entered the AMR system (FSIS Directive 7160.2, April 14, 1997). Under the revised regulatory sampling program, FSIS inspection program personnel take samples of beef AMR product on a routine basis to verify that spinal cord tissue is not present in such product (FSIS Directive 7160.03, Revision 1, August 25, 2003). If spinal cord tissue is detected in beef AMR product, FSIS inspection program personnel take regulatory control action against the AMR product and equipment to prevent misbranded product from entering commerce. If the establishment has distributed misbranded beef AMR product, FSIS requests a voluntary recall. Removal of the spinal cord before the vertebral columns enter the AMR system does not always ensure that spinal cord or DRG will not be incorporated into the final product. The Harvard study found that, if a beef carcass is mis-split when the spinal cord is removed, a portion of the spinal cord may remain encapsulated in the spinal canal of the vertebral column, and, if it is not removed before the vertebral bones enter the AMR system, the spinal cord could contaminate the final AMR product. Even when the spinal cord is completely removed from the vertebral column, the DRG of cattle are firmly attached to the bones of the vertebral column and are not removed along with the spinal cord. Thus, removing the spinal cord from the vertebral column does not prevent the DRG from entering an AMR system and becoming incorporated into the final AMR product. Although FSIS and the regulated industry have recently taken actions to prevent the incorporation of spinal cord and, in some instances, DRG, in beef AMR products (Ref. 15 and 16, available for viewing by the public in the FSIS docket room), FSIS continues to detect spinal cord and DRG in its routine regulatory sampling of beef AMR products, although to a lesser extent than it did in the 2002 Beef AMR Survey. In its routine regulatory sampling conducted from March to December in 2003, FSIS detected spinal cord in 23 of 340 randomly scheduled samples, an estimated prevalence of 6.8 percent. In addition, the prevalence in follow-up samples was 13.6 percent, indicating that establishments with an initial positive continued to have some problems controlling for spinal cord in beef AMR systems. While FSIS was testing samples for spinal cord, FSIS also recorded the results for DRG. The prevalence for DRG was found in 10.9 percent of the samples in which DRG was recorded. Under the current regulations, AMR product that contains DRG is not misbranded and can be identified as meat. However, given the nature of DRG, and the fact that BSE has been confirmed in a cow in the United States, FSIS has reconsidered its approach to this tissue and is issuing a separate interim final rule on AMR systems in this edition of the Federal Register that reflects recent developments that have occurred with regard to BSE. The interim final rule on AMR systems also establishes non-compliance criteria to discern ``meat'' from non-meat product. Mechanically Separated (MS)(Beef). MS(Beef) meat food product is a finely comminuted product resulting from the mechanical separation and removal of most of the bone from attached skeletal muscle of cattle carcasses and parts of carcasses that meets the specifications contained in 9 CFR 319.5, the regulation that prescribes the standard of identity for MS(Species). Unlike AMR systems in which bone and bone products are not purposefully incorporated in the final meat product, MS(Species) systems are designed to purposefully incorporate significant amounts of bone and bone components in the resulting meat food product. The specifications for product identified as MS(Species) in 9 CFR 319.5 do not establish limits on the incorporation of spinal cord or DRG into this product. Although beef products produced using AMR systems that contain spinal cord cannot be identified as meat, if these products meet the specifications contained in 9 CFR 319.5, they are permitted to be labeled as MS(Beef). Under the current regulations, MS(Species) product is permitted for use as an ingredient in other processed meat and poultry products in limited amounts (9 CFR 319.6). When MS(Beef) is used as an ingredient in meat or poultry products, it must be identified in the ingredients statement as [[Page 1867]] MS(Beef). However, the fact that MS(Beef) may contain spinal cord or DRG is not required to be conveyed on the labeling of MS(Beef) product or processed products that contain MS(Beef). The fact that MS(beef) has been permitted to include spinal cord and DRG makes this product an obvious source of potential human exposure to the BSE agent. Given that a case of BSE was recently confirmed in the United States, FSIS believes that it is necessary to remove this high-risk product from the human food supply. Therefore, in this interim final rule, the Agency is banning the use of MS(beef) for human food. Accordingly, no product may bear the label (MS(Beef)). However, certain products from bones that do not contain CNS tissue, e.g., long bones, that may contain excess bone solids or bone marrow may be produced but must be labeled with an appropriate common or usual name (refer to the interim final rule, ``Meat Produced by Advanced Meat/Bone Separation Machinery and Meat Recovery Systems,'' docket number 03-038IF published in this edition of the Federal Register). The Harvard Risk Assessment In April 1998, USDA commissioned the Harvard Center for Risk Analysis to conduct an analysis and evaluation of the current measures implemented by the United States government to prevent the spread of BSE in the United States and to reduce the potential exposure of Americans to the BSE agent. The risk assessment (referred to below as the Harvard study) reviewed available scientific information related to BSE and other TSEs, assessed pathways by which BSE could potentially occur in the United States, and identified measures that could be taken to protect human and animal health in the United States (Ref. 17, available for viewing by the public in the FSIS docket room and on the Internet at http://www.fsis.usda.gov/OA/topics/bse.htm). The Harvard study concluded that if introduced, due to the preventive measures currently in place in the United States, BSE is extremely unlikely to become established in the United States. Should BSE enter the United States, the Harvard study concluded that only a small amount of potentially infective tissues would likely reach the human food supply and be available for human consumption. The Harvard study expressed the amount of infectivity in terms of cattle oral ID50s for the purpose of quantifying both animal and human exposure to the BSE agent. A cattle oral ID50 is the amount of infectious tissue that would be expected to cause 50% of exposed cattle to develop BSE. Because the exact quantitative relationship between human exposure to the BSE agent and the likelihood of human disease is unknown, the Harvard study did not evaluate the quantitative likelihood that humans will develop vCJD if BSE were introduced into the United States. The Harvard study also did not address potential human exposure to the BSE agent through products containing ingredients of bovine origin, such as some pharmaceuticals, gelatin, and beef stocks, extracts, and flavorings. Many of these products are derived through the edible rendering process. FSIS is working with FDA, the agency that regulates the use of these products, to address the impact of this issue. The Harvard study identified three pathways or practices that could contribute most to either human exposure to the BSE agent or to the spread of BSE should it be introduced into the United States. The three pathways are: [sbull] Noncompliance with FDA regulations prohibiting the use of certain proteins in feed for cattle and other ruminants; [sbull] Rendering of animals that die on the farm and use (through illegal diversion or cross-contamination) of the rendered product in ruminant feed; [sbull] Inclusion of high-risk tissue from cattle, such as brain and spinal cord, in edible products. FDA and USDA's APHIS are taking action to address the first two pathways. FDA is enhancing its enforcement of the feed ban and is evaluating whether further rulemaking is needed (see Advance Notice of Proposed Rulemaking, ``Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed,'' 67 FR 67572, November 6, 2002). APHIS is developing approaches to control the potential risk that dead stock and non-ambulatory animals could serve as potential pathways for the spread of BSE (see Advance Notice of Proposed Rulemaking, ``Risk Reduction Strategies for Potential BSE Pathways Involving Downer Cattle and Dead Stock of Cattle and Other Species,'' 68 FR 2703, January 21, 2003). FSIS is prohibiting the use of certain materials from cattle for human food to address the third potential pathway identified in the Harvard study, the inclusion of high-risk tissues in edible product. In addition, in a separate rulemaking published in this edition of the Federal Register, FSIS is prohibiting the use of penetrative stunning devices that inject air into the cranial cavity of cattle to ensure that portions of the brain are not dislocated into the tissues of the carcass as a consequence of humanely stunning cattle during the slaughter process (see ``Prohibition on the Use of Certain Stunning Devices Used to Immobilize Cattle During Slaughter,'' Docket 01-033IF). Although FSIS is not aware of any cattle slaughter establishments in the United States that use air-injection stunning, research has shown that this practice poses a risk of exposing humans to materials that could contain the BSE agent. Given that a case of BSE was recently confirmed in the United States, FSIS believes that this prohibition is a necessary measure to help strengthen the U.S. Government's actions to prevent human exposure to the BSE agent. The Harvard study concluded that, based on conditions as they existed in 2001, if 10 infected cows were introduced into the United States, on average, three additional new cases of BSE in cattle would be expected. In fact, Harvard predicted that there was a 75 to 95% chance that there would be no new cases at all. The extreme case (95th percentile of the distribution) predicted 11 new cases. However, in all cases, the system in 2001 was robust enough so that model predicts that the disease would be quickly cleared from the United States with virtually no chance that there would be any infected animals 20 years following the import of the 10 infected cattle. The Harvard study concluded the greatest sources of potential human exposure to the BSE agent would be human consumption of cattle brain (26% of the total potential exposure on average), cattle spinal cord (5% of the total potential exposure on average), and beef products derived from AMR systems (57% of the total potential exposure on average). The Harvard study also determined that other potential human exposure routes to the BSE agent include consumption of bone-in beef (11% of the total potential exposure on average), and intestine (2% of the total potential exposure on average). However, as stated in the Harvard study report, these estimates are likely to overstate true human exposure because they represent the amount of infectivity presented for human consumption but do not take into account waste or actual consumption rate. For example, the reported quantity for potential exposure to infectivity in bone-in beef reflects the presence of spinal cord and DRG in a fraction of cuts like T-bone steaks, although the spinal cord and DRG may never be consumed in these cuts of meat. [[Page 1868]] The Harvard study divided potential sources of human exposure to BSE infectivity into two categories: specific high-risk tissues and contamination of low risk tissues with high-risk tissues. Specific high-risk tissues identified by Harvard, in order of infectivity, include: brain, spinal cord, DRG, distal ileum, and the trigeminal ganglia and other tissues found in the head (e.g., eyes). Since brain and spinal cord of cattle infected with BSE contain most of the BSE infectivity in the animal, the Harvard study concluded that, if BSE were present in the United States, human consumption of bovine brains and spinal cords would be an obvious source of exposure to the BSE agent. The Harvard study identified the production of meat through the use of AMR systems as the most important means by which low risk tissue can become contaminated with high-risk tissues because AMR systems can leave spinal cord and DRG in the recovered meat. Assuming that there is no SRM ban in place, the Harvard study estimated that beef AMR product could account for approximately 57% of the potential human exposure to the BSE agent. Specified Risk Materials (SRMs) Materials designated as SRMs. In determining which materials of cattle should be removed from the human food supply, FSIS considered the data on the age distribution of confirmed BSE cases in the United Kingdom, the findings of the pathogenesis studies conducted in the United Kingdom, and the findings of the BSE risk analysis conducted by Harvard. After considering the factors mentioned above, together with the fact that a case of BSE was recently confirmed in the United States, FSIS has decided to designate the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and DRG of cattle 30 months of age and older, and the tonsils and distal ileum of all cattle as SRMs, declare them inedible, and prohibit their use for human food. The Agency believes that removing these materials from the human food supply is a prudent and appropriate measure for preventing human exposure to the BSE agent in the United States. Except for the skull and vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum) of cattle 30 months of age and older, the materials listed as SRMs in this interim final rule are all materials that have demonstrated infectivity in cattle naturally or experimentally infected with BSE. Thus, in this rule, FSIS is designating all materials from cattle that have demonstrated BSE infectivity as SRMs, regardless of the level or proportion of infectivity contained in each tissue. Although the skull or vertebral column of cattle infected with BSE have not demonstrated infectivity, the skull contains the eyes, trigeminal ganglia, and brain, and the vertebral column contains DRG and spinal cord. Thus, because they contain high-risk tissues, FSIS is including skulls and vertebral columns (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum) from cattle 30 months of age and older in the list of SRMs that the Agency is declaring inedible and prohibiting for human food. Head meat, cheek meat, and tongue are not part of the skull. Therefore, under this interim final rule, these materials may continue to be used for human food, provided they are not contaminated with SRM. Unlike other parts of the vertebral column, the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum do not contain spinal cord or DRG. Therefore, FSIS is excluding these parts of the vertebral column from the materials designated as SRMs. Under this interim final rule, bone-in beef from cattle 30 months of age and older may be prepared from these sections of the vertebral column. These sections of the vertebral column may also be used as a source material for products produced from edible rendering. The Harvard study identified the production of meat through the use of AMR systems as the most important means by which low risk tissue can become contaminated with high-risk tissues, such as spinal cord and DRG. Furthermore, as discussed above, although FSIS and the regulated industry have taken actions to prevent the incorporation of spinal cord and, in some instances, DRG, in beef AMR products, FSIS continues to detect spinal cord and DRG in its routine regulatory sampling of this product. By designating the vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum) from cattle 30 months of age and older as SRM and prohibiting its use for human food, FSIS will ensure that spinal cord and DRG from cattle 30 months of age and older are not incorporated into beef AMR product. The Harvard study determined that some potential exposure to BSE infectivity would result from the presence of spinal cord and DRG in certain bone-in cuts of beef, such as T-bone steaks. By designating vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum) from cattle 30 months of age and older as SRM and prohibiting its use for human food FSIS will ensure that bone-in cuts of meat from cattle 30 months of age and older will not contain spinal cord or DRG. The Harvard study did not address potential human exposure to the BSE agent through beef stocks, broths, or other products produced from the edible rendering process. However, it is possible that, when vertebral column bones are used as a source material for products produced from edible rendering, spinal cord and DRG could become dislodged from the vertebral bones and incorporated into the final product. By designating vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum) from cattle 30 months of age and older as SRM and prohibiting its use for human food FSIS will ensure that spinal cord and DRG from cattle 30 months of age and older will not be incorporated into beef products produced from the edible rendering process. Because of its proximity to the vertebral column, some hand-deboned meat may contain DRG depending on the technique used to recover the meat from the bone. Thus, hand-deboned meat from cattle could be a potential source of human exposure to DRG. FSIS is not aware of any data on the extent to which DRG are found in hand-deboned meat. FSIS is examining this issue in a study it is conducting to delineate the characteristics of hand-deboned meat. FSIS is not, at this time, prohibiting hand-deboned meat from the vertebral columns of cattle 30 months of age and older for use as human food. The Agency requests comments on this issue. The SRMs prohibited for human food in this interim final rule are the same materials prohibited for use as human food by Canada, thus establishing a consistent standard in both countries. The Canadian SRMs include the skull, brain, trigeminal ganglia, eyes, tonsils, spinal cord, and DRG from cattle 30 months of age and older, and distal ileum from all cattle. Although the vertebral column (excluding the vertebrae of the tail, the transverse process of the thoracic and lumbar [[Page 1869]] vertebrae, and the wings of the sacrum) from cattle 30 months of age and older is not identified as SRM in the Canadian regulations, to ensure complete removal of potentially risky DRG from the human food supply, the Canadian Food Inspection Agency (CFIA) requires that the vertebral column of cattle 30 months of age and older, excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum, be removed and disposed of as inedible product (Meat Hygiene Directive 2003-18 (Amended), July 24 2003). The CFIA also prohibits the use of vertebral columns from cattle 30 months of age and older as a raw material in the preparation of mechanically separated meat or finely textured meat (Meat Hygiene Directive 2003-18 (Amended), July 24, 2003). The Canadian provisions for the removal of SRMs from the carcasses of cattle slaughtered in official Canadian establishments can be accessed on the Internet at http://www.inspection.gc.ca/english/anima/meavia/mmopmmhv/chap4/annexne.shtml . The Canadian SRMs include the distal ileum from all cattle. However, the CFIA presently requires that the small intestine of all cattle be removed and disposed of as inedible product (Meat Hygiene Directive 2003-18 (Amended), July 24, 2003). Therefore, FSIS is designating, consistent with the Canadian rule, the distal ileum of the small intestine as SRM. To ensure that the distal ileum is completely removed from the carcass, FSIS is requiring that establishments remove the entire small intestine and that it be disposed of as inedible. Processors may be able to effectively remove just the distal ileum, and, accordingly, the Agency requests comments on this issue. Rationale. Given the way that infectivity occurs in BSE-infected cattle, and the fact that a case of BSE has been detected in the United States, FSIS has determined that certain materials from cattle present sufficient risk of exposing humans to the BSE agent that it is prudent and appropriate to find that such materials are unfit for human food within the meaning of section 1(m)(3) of the FMIA (21 U.S.C. 601(m)(3)). For the reasons presented above, FSIS has concluded that these materials are the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and DRG of cattle 30 months of age and older, and the tonsils and distal ileum of all cattle. The brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and DRG of cattle 30 months of age and older, and the tonsils and distal ileum of all cattle, present a persistent risk of exposing humans to the BSE agent because, in pre-clinical BSE-infected cattle, infectivity in most of these tissues is not readily ascertainable. Thus, humans could unknowingly be exposed to the BSE agent through consumption of these materials. By designating the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and DRG of cattle 30 months of age and older, and the tonsils and distal ileum of all cattle as SRMs, declaring that they are inedible, and prohibiting their use for human food, FSIS will ensure that materials that could present a significant risk to human health, but whose infectivity status cannot be readily ascertained, are excluded from the human food supply. Procedures for the Removal, Segregation, and Disposition of SRMs In this interim final rule, FSIS is requiring that establishments that slaughter cattle and establishments that process the carcasses or parts of cattle develop, implement, and maintain written procedures for the removal, segregation, and disposition of SRMs (section 310.22(d)(1)). The Agency is not prescribing specific procedures that establishments must follow because FSIS believes that establishments should have the flexibility to implement the most appropriate procedures that will best achieve the requirements of this rule. Establishments are responsible for ensuring that SRMs are completely removed from the carcass, segregated from edible products, and disposed in an appropriate manner. Establishments must address their control procedures in their HACCP plans, Sanitation SOPs, or other prerequisite programs. FSIS will ensure the adequacy and effectiveness of the establishment's procedures. This interim final rule also requires (section 310.22(d)(4)) that establishments that slaughter cattle and establishments that process the carcasses or parts of cattle maintain daily records that document the implementation and monitoring of their procedures for the removal, segregation, and disposition of SRMs, and that the establishments make these records available to FSIS personnel on request. FSIS will develop compliance guidelines for use by very small and small establishments to assist them in the development of validated methods for meeting the requirements of this interim final rule. FSIS believes that the use of the Canadian guidance on SRM removal generally is acceptable. FSIS will assess whether additional guidance is necessary (see the FSIS docket room and the FSIS Web site for the link to the Canadian and other compliance guidance information). Verification of the Age of Cattle Most of the materials that FSIS is prohibiting for use as human food in this rulemaking are from cattle 30 months of age and older. Thus, FSIS is prescribing the method that inspection program personnel will use to determine the age of cattle slaughtered in official establishments, to verify that the establishments are effectively segregating SRMs from edible materials. The Agency is aware of two methods that can be used to verify the age of cattle slaughtered in official establishments: (1) Documentation that identifies the age of the animal, such as a birth certificate, cattle passport, or some other form of identification, that is presented with the animal when it arrives for slaughter, and (2) examination of the dentition of the animal to determine whether at least one of the second set of permanent incisors has erupted (the permanent incisors of cattle erupt from 24 through 30 months of age). The Agency has decided to use a combination of both methods. If the establishment has records that document the age of the cattle slaughtered in the facility, FSIS inspection program personnel will examine the records. If the inspection program personnel conclude that the records are accurate and reliable, they will accept the records as verification of the age of the cattle. However, if FSIS inspection program personnel examine the records and find significant reasons for questioning their validity, they will verify the age of the cattle through dental examination. If the establishment does not have records that document the age of the cattle presented for slaughter, or the inspection program personnel have any reason to question the age of the animals, the Agency will verify age through dental examination. In establishments that only process the carcasses and parts of carcasses of cattle, the Agency will verify age through establishment records that document the age of the cattle from [[Page 1870]] which the carcasses were derived. If the establishment does not have records that document the age of the cattle from which the carcasses were derived, it must handle all carcasses and parts of carcasses as if they came from cattle 30 months of age and older. Although there are various methods of cattle identification in the United States, there is no national cattle identification system. Thus, there is currently no uniform standard of documentation that FSIS can rely on to accurately verify the age of cattle slaughtered in official establishments. On December 30, 2003, the Secretary of Agriculture announced that the USDA will implement a system of national animal identification. The development of such a system has been underway for more than a year and a half to achieve uniformity, consistency, and efficiency across this national system. FSIS has developed instructions for use by its inspection personnel in verifying the age of cattle that is available for viewing by the public in the FSIS docket room and posted on the FSIS Web site. Non-Ambulatory Disabled Cattle Current regulatory requirements. FSIS' regulations prohibit for use as human food all livestock, including cattle, with clinical signs of a CNS disorder (9 CFR 309.4) and livestock that are in a dying condition or that died otherwise than by slaughter (9 CFR 309.3). Under the current regulation, all seriously crippled livestock and livestock commonly termed ``downers'' presented for slaughter are automatically suspected of being affected with a disease or condition that may require condemnation of the animal, in whole or in part, and are identified as ``U.S. Suspects'' (9 CFR 309.2(b)). Such animals are examined at ante-mortem inspection by an FSIS veterinarian, and a record of the veterinarian's clinical findings accompanies the carcass to post-mortem inspection if the animal is not condemned on ante-mortem inspection. Post-mortem inspections of the carcasses of ``U.S. Suspect'' livestock are performed by veterinarians rather than by food inspectors, and the results of this inspection are recorded. ``U.S. Suspects,'' unless otherwise released pursuant to 9 CFR 309.2(p), must be set apart and slaughtered separately (9 CFR 309.2(n)). If, on post- mortem inspection, the meat and meat food products from such animals are found to be not adulterated, such products may be used for human food (9 CFR 311.1). Non-ambulatory cattle and BSE. Surveillance data from European countries in which BSE has been detected, indicate that cattle with clinical signs of a CNS disorder, dead cattle, and cattle that can not rise from a recumbent position (in Europe these cattle are distinguished either as ``fallen stock'' if not for human consumption or ``emergency slaughter'' cattle if for human consumption) have a greater incidence of BSE than healthy slaughter cattle. For example, in 2002 the EU reported that for healthy cattle 55-60 months of age, there were 0.55 positive tests for BSE per 10,000 animals tested compared with 3.05 positive tests for BSE per 10,000 cattle tested for the high- risk cattle (i.e., fallen stock, emergency slaughter and animals that show clinical signs of BSE on ante-mortem inspection) (Ref. 18, available for viewing by the public in the FSIS docket room). In addition, an analysis of a targeted screening program for BSE in Switzerland found that when high-risk cattle were targeted for BSE testing, the odds of finding a BSE case was 49 times higher in fallen stock and 58 times higher in emergency-slaughtered cattle than in cattle tested under passive surveillance, i.e., clinical BSE suspects reported to the veterinary authorities (Ref. 19, available for viewing by the public in the FSIS docket room). This study also found that the BSE cases detected through targeted screening of high risk animals were on average four months younger than the BSE cases detected through passive surveillance of clinical suspects. Surveillance for BSE in Europe has also shown that the typical clinical signs associated with BSE cannot always be observed in non- ambulatory cattle infected with BSE because the signs of BSE often cannot be differentiated from the typical clinical signs of the many other diseases and conditions affecting non-ambulatory cattle. Furthermore, as discussed in greater detail below, there are limitations with the diagnostic tests for BSE that are available today. Under the current testing methods, which are conducted on sections of the brain or spinal cord, certain tissues of cattle infected with BSE, such as the distal ileum and tonsils, may contain BSE infectivity even though the diagnostic test does not show that the animal has the disease. Thus, permitting the carcasses of non-ambulatory cattle to be used for human food if the animal tests negative for BSE will not provide the same level of protection against human exposure to the BSE agent that prohibiting these cattle from entering the human food supply will. Revised regulatory requirements. Because they present a risk of introducing the BSE agent into the human food supply, FSIS has determined that the carcasses of non-ambulatory disabled cattle are unfit for human food under section 1(m)(3) of the FMIA and that all non-ambulatory disabled cattle that are presented for slaughter should be condemned. Therefore, FSIS is amending its ante-mortem inspection regulations to require the condemnation of non-ambulatory disabled cattle presented for slaughter. Specifically, FSIS is amending the regulations that prescribe requirements for ``U.S. Suspect'' livestock in 9 CFR 309.2 by replacing the reference to ``animals commonly termed `downers' ' in Sec. 309.2(b) with the term ``non-ambulatory disabled livestock.'' FSIS is making this modification because there is currently no regulatory definition of ``downer'' and the Agency believes that the term ``non- ambulatory disabled'' more accurately describes the cattle that it believes should be prohibited for human food. ``Non-ambulatory disabled livestock'' is defined as livestock that cannot rise from a recumbent position or that cannot walk, including, but not limited to, those with broken appendages, severed tendons or ligaments, nerve paralysis, fractured vertebral column, or metabolic conditions. Thus, this definition includes livestock that are non-ambulatory due to an acute injury in route to the slaughter facility, such as a broken leg, as well as livestock that are non-ambulatory due to an underlying pathological condition. FSIS is excluding all non-ambulatory disabled cattle from the human food supply, regardless of the reason for their non-ambulatory status or the time at which they became non-ambulatory. Thus, if an animal becomes non-ambulatory in route to the establishment due to an acute injury, it must be humanely removed from the truck, humanely euthanized, and the carcass properly disposed of. Likewise, cattle that become non-ambulatory on the establishment premises, such as an animal that breaks its leg as it is unloaded from the truck, are also required to be humanely moved, humanely euthanized, and the carcass properly disposed of. FSIS is also amending the regulations that prescribe requirements for dead, dying, disabled, or diseased and similar livestock in 9 CFR 309.3 to require that non-ambulatory disabled cattle be condemned and disposed of in accordance with 9 CFR 309.13. Unless another provision in part 309 applies, under Sec. 309.13, condemned livestock must be killed by the establishment, if [[Page 1871]] not already dead. Such animals cannot be taken into the establishment to be slaughtered or dressed, or conveyed into any department of the establishment that is used for edible products. The carcasses of condemned livestock must be disposed of in the manner provided for in part 314. Under part 314, condemned carcasses must be disposed of by ``tanking,'' i.e., inedible rendering (9 CFR 314.1). For those establishments that do not have facilities for tanking, condemned carcasses may be disposed of by incineration or denatured by crude carbolic acid, cresylic disinfectant, a formula consisting of one part FD&C No. 3 green coloring, 40 parts water, 40 parts liquid detergent, and 40 parts oil of citronella, or any other proprietary material approved by the Administrator of FSIS (9 CFR 314.3). The Agency is aware that many establishments use activated charcoal to denature inedible materials. Therefore, FSIS recognizes activated charcoal as a proprietary substance approved by the Administrator. The regulations in 9 CFR 311.27 permit injured livestock to be slaughtered for humane reasons at hours when an inspector is not available to perform ante-mortem inspection, provided that the carcasses and parts of such animals are kept for inspection. To ensure that non-ambulatory disabled cattle are not slaughtered under this provision and their carcasses and parts used for human food, FSIS is amending 9 CFR 311.27 to prohibit the carcasses and parts of carcasses from cattle slaughtered on an emergency basis without ante-mortem inspection from being used for human food. Without performing ante- mortem inspection on cattle slaughtered on an emergency basis, FSIS inspection program personnel cannot determine whether the carcasses or parts from such cattle came from a non-ambulatory disabled animal, and thus cannot find that the carcasses and parts from these emergency slaughter cattle are not adulterated. Testing Cattle for BSE There is no sensitive and reliable live animal test for BSE, and the available post-mortem diagnostic tests can only indicate that cattle have the disease two to three months before the onset of clinical disease or after the onset of clinical disease. Given the limitations of the diagnostic tests available today, which are conducted on sections of the brain or spinal cord, certain tissues of cattle infected with BSE, such as distal ileum and small intestine, may contain BSE infectivity even though the diagnostic test will not show that the animal has the disease. Thus, exempting materials from cattle that test negative for BSE from the restrictions in this rulemaking will likely not provide the same level of protection as prohibiting those materials for use as human food. Therefore, under this interim final rule, the use of specified risk materials from cattle is prohibited for human food regardless of whether the animal has been tested for BSE. FSIS requests comments on whether further consideration should be given to exempting cattle that have tested negative for BSE from the requirements contained in this interim final rule, and if so, what testing methods and protocols the Agency should accept as providing acceptable and reliable results. Request for Comments FSIS requests comments on the measures contained in this interim final rule, and specifically on whether the Agency has chosen measures that are most appropriate for preventing human exposure to the BSE agent in the United States. Emergency Action The fact that a cow in Washington State tested as positive for BSE on December 23, 2003, makes this rulemaking necessary on an emergency basis. As discussed above, BSE infectivity has been confirmed in the brain, eyes, trigeminal ganglia, tonsils, spinal cord, DRG and distal ileum. Furthermore, most of these tissues have demonstrated infectivity before experimentally infected animals developed clinical signs of disease. Thus, BSE infectivity in these tissues is not readily ascertainable. Therefore, FSIS has determined that it must take immediate action to ensure that materials that could present a significant risk to human health are excluded from the human food supply. Under these circumstances, the FSIS Administrator has determined that prior notice and opportunity for public comment are contrary to the public interest, and that there is good cause under 5 U.S.C. 553 for making this rule effective less than 30 days after publication in the Federal Register. FSIS will consider comments received during the comment period for this interim rule (see DATES above). After the comment period closes, the Agency will publish another document in the Federal Register. The document will include a discussion of any comments received in response to this interim rule and any amendments made as a result of those comments. In an effort to ensure that establishments comply with this interim final rule upon publication in the Federal Register, FSIS will provide guidance to inspection program personnel regarding the implementation strategy. At a minimum, FSIS inspection program personnel will be directed to meet with management of each affected establishment to discuss how and when the establishment expects to complete its reassessment of its HACCP plan and to ensure that SRMs and MS (Beef) do not adulterate product. Executive Order 12866 and Regulatory Flexibility Act This rule has been reviewed under Executive Order 12866. It has been determined to be economically significant for purposes of Executive Order 12866 and therefore, has been reviewed by the Office of Management and Budget (OMB). The emergency situation surrounding this rulemaking makes timely compliance with Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) impracticable. FSIS is currently assessing the potential economic effects of this action. When this work is complete, the Agency will publish a notice of availability in the Federal Register and will provide an opportunity for public comment. Executive Order 12988 This interim final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts State and local laws and regulations that are inconsistent with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule. However, the administrative procedures specified in 9 CFR 306.5. must be exhausted before any judicial challenge of the application of the provisions of this interim final rule, if the challenge involves any decision of an FSIS employee relating to inspection services provided under the FMIA or PPIA. Paperwork Reduction Act In accordance with section 3507(j) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), the information collection and recordkeeping requirements included in this interim final rule have been submitted for emergency approval to the Office of Management and Budget (OMB). Title: Prohibition of the Use of Specified Risk Materials for Human Food and Requirements for the Disposition of Non-Ambulatory Disabled Cattle. [[Page 1872]] Type of collection: New. Abstract: In this interim final rule, FSIS is requiring that establishments that slaughter cattle and establishments that process the carcasses or parts of cattle develop written procedures for the removal, segregation, and disposition of SRMs. FSIS is also requiring that these establishments maintain daily records sufficient to document the implementation and monitoring of their procedures for the removal, segregation, and disposition of SRMs, and any corrective actions taken. These records are needed for FSIS to verify the effectiveness of an establishment's procedures. Estimate of burden: FSIS estimates that it will take establishments approximately 8 hours to develop written procedures for the removal, disposition, and segregation of SRMs. FSIS estimates that an establishment will spend about five minutes a day developing an average of nine monitoring records, which includes documentation of any corrective actions taken, and an additional two minutes a day to file each record. Respondents: Official establishments that slaughter cattle and official establishments that process the carcasses or parts of cattle. Estimated Number of Respondents: 2,500. Estimated Number of Responses per Respondent: 2,701. Estimated Total Annual Burden on Respondents: 807,500 hours. Copies of this information collection assessment can be obtained from John O'Connell, Paperwork Reduction Act Coordinator, Food Safety and Inspection Service, USDA, 112 Annex, 300 12th Street, SW., Washington, DC 20250 Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (b) the accuracy of the Agency's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected, ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques, or other forms of information technology. Comments may be sent to both John O'Connell, Paperwork Reduction Act Coordinator, at the address provided above, and the Desk Officer for Agriculture, Office of information and Regulatory Affairs, Office of Management and Budget, Washington, DC 20253. To be most effective, comments should be sent to OMB within 30 days of the publication date of this interim final rule. Government Paperwork Elimination Act (GPEA) FSIS is committed to achieving the goals of the GPEA, which requires that Government agencies, in general, provide the public with the option of submitting information or transacting business electronically to the maximum extent possible. Under this interim final rule, records that document the implementation and monitoring of an establishment's procedures for the removal, segregation, and disposition of SRMs may be maintained on computers, provided that the establishment implements appropriate controls to ensure the integrity of the electronic data. Allowing establishments to comply with the required recordkeeping requirements will reduce data collection time, and information processing and handling by the regulated industry and FSIS. Additional Public Notification Public awareness of all segments of rulemaking and policy development is important. Consequently, in an effort to better ensure that minorities, women, and persons with disabilities are aware of this final interim final rule and are informed about the mechanism for providing their comments, FSIS will announce it and provide copies of this Federal Register publication in the FSIS Constituent Update. FSIS provides a weekly FSIS Constituent Update, which is communicated via fax to over 300 organizations and individuals. In addition, the update is available on line through the FSIS Web page located at http://www.fsis.usda.gov. The update is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, recalls, and any other types of information that could affect or would be of interest to our constituents/stakeholders. The constituent fax list consists of industry, trade, and farm groups, consumer interest groups, allied health professionals, scientific professionals, and other individuals that have requested to be included. Through these various channels, FSIS is able to provide information to a much broader, more diverse audience. For more information and to be added to the constituent fax list, fax your request to the Congressional and Public Affairs Office, at (202) 720- 5704. References The following sources are referred to in this document. All have been placed on display in the FSIS Docket Room (address above) and may be seen by interested persons between 8:30 a.m. and 4:30 p.m., Monday through Friday. Materials that are not copyright protected may also be accessed on the FSIS Web site as related documents to this interim final rule. 1. Will, R.G., et al., A new variant of Creutzfeldt-Jakob disease in the UK. Lancet 347, 921-925 (1996). 2. Collinge, J., et al., Molecular analysis of prion strain variation and the aetiology of ``new variant'' CJD. Nature 383, 685-690 (1996). 3. Bruce, M.E., et al., Transmission to mice indicates that ``new variant'' CJD is caused by the BSE agent. Nature 389, 498-501 (1997). 4. Scott, M.R., et al., Compelling transgenentic evidence for transmission of bovine spongiform encephalopathy prions to humans. Proc Natl Acad Sci USA 96, 15137-12142 (1997). 5. Belay, E.D., et al., Relationship between transmissible spongiform encephalopathies in animals and humans. In: Task Force Report of the Council for Agricultural Science and Technology. Washington, DC: Council for Agricultrual Science and Technology, October 2002, No. 136. 6. MMWR, Probable Variant Creutzfeldt-Jakob Disease in a U.S. Resident--Florida, 2002, 51(41):927-929 (October 18, 2002). 7. Department for Environment Food and Rural Affairs, United Kingdom, FSIS personal communication. 8. European Union Scientific Steering Committee (EU SSC), 2002. Update on the Opinion of TSE infectivity distribution in ruminant tissues (initially adopted by the scientific steering committee at its meeting of 10-11 January 2002 and amended at its meeting of 7-8 November 2002) following the submission of (1) a risk assessment by the German Federal Ministry of Consumer Protection Food and Agriculture, and (2) new scientific evidence regarding BSE infectivity distribution in tonsils; European Commission, Scientific Steering Committee, Health and Consumer Protection Directorate General. 9. Department for Environment Food and Rural Affairs, United Kingdom, DEFRA BSE Information, Youngest and oldest cases by year of onset-GB (Passive surveillance only), September 30, 2003. [[Page 1873]] 10. Wells, G.A.H., et al., Infectivity in the ileum of cattle challenged orally with bovine spongiform encephalopathy. Veterinary Record 135, 40-41 (1994). 11. Wells, G.A.H., et al., Preliminary observations on the pathogenesis of experimental bovine spongiform encephalopathy (BSE): an update. Veterinary Record 142, 103-106 (1998). 12. Wells, G.A.H. Limited detection of sternal bone marrow infection in the clinical phase of experimental bovine spongiform encephalopathy. Veterinary Record 144, 292-294 (1999). 13. United Kingdom Food Standards Agency press release, Thursday, October 17, 2002. 14. European Union Scientific Steering Committee (EU SSC), 2001. Opinion of 10 December 1999 of the Scientific Steering Committee on the Human Exposure Risk (HER) via Food with Respect to BSE. 15. Analysis of 2002 FSIS Bovine AMR Products Survey Results, prepared by the United States Department of Agriculture, Food Safety and Inspection Service, February 2003. Available on the Internet at http://www.fsis.usda.gov/oa/topics/AMRAnalysis.pdf. 16. The Follow-up to the Beef AMR Product Survey of 2002: Follow-up Results and Actions for the Elimination of CNS (Spinal Cord) Tissues from AMR Products Derived from Beef Vertebrae, prepared by the Food Safety and Inspection Service, February 2003. Available on the Internet at http://www.fsis.usda.gov/OA/topics/AMRSurvey.pdf. 17. Harvard Center for Risk Analysis, Harvard School of Public Health, and Center for Computational Epidemiology, College of Veterinary Medicine, Tuskegee University, November 26, 2001. Evaluation of the Potential for Bovine Spongiform Encephalopathy in the United States. 18. European Commission, 2003. ``Report on the Monitoring and Testing of Ruminants for the Presence of Transmissible Spongiform Encephalopathy (TSE) in 2002,'' p. 49. 19. Doherr, M.G., et al., Targeted screening of high-risk cattle populations for BSE to augment mandatory reporting of clinical suspects. Preventive Veterinary Medicine 51:1-2, 3-16 (2001). List of Subjects 9 CFR Part 309 Ante-mortem inspection, Disposition of carcasses. 9 CFR Part 310 Post-mortem inspection, Disposition of carcasses. 9 CFR Part 311 Post-mortem inspection, Disposition of carcasses. 9 CFR Part 318 Entry into official establishments, reinspection and preparation of products. 9 CFR Part 319 Food grades and standards, Food labeling, Meat inspection. 0 For the reasons discussed in the preamble, FSIS is amending 9 CFR Chapter III as follows: PART 309--ANTE-MORTEM INSPECTION 0 1. The authority citation for part 309 continues to read as follows: Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55. 0 2. Paragraph (b) of Sec. 309.2 is revised to read as follows: Sec. 309.2 Livestock suspected of being diseased or affected with certain conditions; identifying suspects; disposition on post-mortem inspection or otherwise. * * * * * (b) All seriously crippled animals and non-ambulatory disabled livestock shall be identified as U.S. Suspects and disposed of as provided in Sec. 311.1 of this subchapter unless they are required to be classed as condemned under Sec. 309.3. Non-ambulatory disabled livestock are livestock that cannot rise from a recumbent position or that cannot walk, including, but not limited to, those with broken appendages, severed tendons or ligaments, nerve paralysis, fractured vertebral column, or metabolic conditions. * * * * * 0 3. Section 309.3 is revised by adding a new paragraph (e) to read as follows: Sec. 309.3 Dead, dying, disabled, or diseased and similar livestock. * * * * * (e) Non-ambulatory disabled cattle shall be condemned and disposed of in accordance with Sec. 309.13. PART 310--POST-MORTEM INSPECTION 0 4. The authority citation for part 310 continues to read as follows: Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53. 0 5. A new Sec. 310.22 is added to read as follows: Sec. 310.22 Specified risk materials from cattle and their handling and disposition. (a) The following materials from cattle are specified risk materials: (1) The brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months of age and older; (2) The tonsils of all cattle; and (3) The distal ileum of all cattle. To ensure effective removal of the distal ileum, the establishment shall remove the entire small intestine, and shall dispose of it in accordance with Sec. Sec. 314.1 or 314.3 of this subchapter. (b) Specified risk materials are inedible and shall not be used for human food. (c) Specified risk materials shall be disposed of in accordance with Sec. Sec. 314.1 or 314.3 of this subchapter. (d) Procedures for the removal, segregation, and disposition of specified risk materials. (1) Establishments that slaughter cattle and establishments that process the carcasses or parts of cattle shall develop, implement, and maintain written procedures for the removal, segregation, and disposition of specified risk materials. The establishment shall incorporate such procedures into its HACCP plan or in its Sanitation SOP or other prerequisite program. (2) Establishments that slaughter cattle and establishments that process the carcasses or parts of cattle must take appropriate corrective action when either the establishment or FSIS determines that the establishment's procedures for the removal, segregation, and disposition of specified risk materials, or the implementation or maintenance of such procedures, have failed to ensure that such materials are adequately and effectively removed from the carcass of cattle, segregated from edible materials, and disposed of in accordance with paragraph (c) of this section. (3) Establishments that slaughter cattle and establishments that process the carcasses or parts of cattle shall routinely evaluate the effectiveness of their procedures for the removal, segregation, and disposition of specified [[Page 1874]] risk materials in preventing the use of these materials for human food and shall revise the procedures as necessary whenever any changes occur that could affect the removal, segregation, and disposition of specified risk materials. (4) Recordkeeping requirements. (i) Establishments that slaughter cattle and establishments that process the carcasses or parts of cattle shall maintain daily records sufficient to document the implementation and monitoring of the procedures for the removal, segregation, and disposition of the materials listed in paragraph (a) of this section, and any corrective actions taken. (ii) Records required by this section may be maintained on computers provided that the establishment implements appropriate controls to ensure the integrity of the electronic data. (iii) Records required by this section shall be retained for at least one year and shall be accessible to FSIS. All such records shall be maintained at the official establishment 48 hours following completion, after which they may be maintained off-site provided such records can be made available to FSIS within 24 hours of request. (e) The materials listed in paragraph (a)(1) of this section will be deemed to be from cattle 30 months of age and older unless the establishment can demonstrate that the materials are from an animal that was younger than 30 months of age at the time of slaughter. PART 311--DISPOSAL OF DISEASED OR OTHERWISE ADULTERATED CARCASSES AND PARTS 0 6. The authority citation for part 311 continues to read as follows: Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55. Sec. 311.27 [Amended] 0 7. Section 311.27 is amended as follows: 0 a. By inserting ``of all livestock except for cattle'' in the first sentence after ``the carcass and all parts'' and before ``shall be kept for inspection''. 0 b. By adding the following new sentence at the end of the paragraph: ``The parts and carcasses of cattle slaughtered in the absence of an inspector shall not be used for human food.'' PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS 0 8. The authority citation for part 318 is revised to read as follows: Authority: 7 U.S.C. 138f, 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR 2.18, 2.53. Sec. 318.6 [Amended] 0 9. Section 318.6 is amended as follows: 0 a. Paragraph (b)(1) is amended by removing the word ``cattle'' and adding the following new sentence at the end of the paragraph: ``Casings from cattle may be used as containers of products provided the casings are not derived from the small intestine.'' 0 b. Paragraph (b)(4) is amended by adding the following new sentence at the end of the paragraph: ``Detached spinal cords from cattle 30 months of age and older shall not be used as raw materials for edible rendering.'' 0 c. Paragraph (b)(8) is amended by adding the following new sentence at the end of the paragraph: ``The small intestine of cattle shall not be used in any meat food products or for edible rendering.'' PART 319--DEFINITIONS AND STANDARDS OF IDENTITY OR COMPOSITION 0 10. The authority citation for part 319 continues to read as follows: Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR 2.17, 2.55. 0 11. Section 319.5 is amended as follows: 0 a. A new paragraph (b) is added to read as follows: Sec. 319.5 Mechanically Separated Species. * * * * * (b) Mechanically Separated (Beef) is inedible and prohibited for use as human food. * * * * * Done at Washington, DC, on January 7, 2004. Garry L. McKee, Administrator. [FR Doc. 04-625 Filed 1-8-04; 1:43 pm] ----------------------------------------------------------------------- [Federal Register: January 12, 2004 (Volume 69, Number 7)] [Rules and Regulations] [Page 1885-1891] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr12ja04-27] ----------------------------------------------------------------------- DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service 9 CFR Parts 310 and 313 [Docket No. 01-033IF] Prohibition of the Use of Certain Stunning Devices Used to Immobilize Cattle During Slaughter AGENCY: Food Safety and Inspection Service, USDA. ACTION: Interim final rule with request for comments. ----------------------------------------------------------------------- SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the Federal meat inspection regulations to prohibit the use of penetrative captive bolt stunning devices that deliberately inject air into the cranial cavity of cattle. This rulemaking responds to the findings of a risk assessment on bovine spongiform encephalopathy (BSE) conducted by the Harvard Center for Risk Analysis (referred to as the Harvard study) and is part of a series of actions that the USDA is taking to strengthen its BSE prevention programs. The Harvard study found that, owing to already ongoing Federal programs, the U.S. is highly resistant to the introduction and spread of the disease. Even so, the USDA response to BSE has always been proactive and preventive. Therefore, FSIS is taking this action to address the potential risk posed by stunning devices that may force visible pieces of brain, known as macro-emboli, into the circulatory system of stunned cattle. [[Page 1886]] DATES: Effective January 12, 2004; comments received on or before April 12, 2004 will be considered prior to issuance of a final rule. ADDRESSES: Send an original and two copies of comments to: FSIS Docket Clerk, Docket 01-033IF, Room 102, Cotton Annex, 300 C Street, SW., Washington, DC 20250-3700. Reference materials cited in this document and any comments received will be available for public inspection in the FSIS Docket Room from 8:30 a.m. to 4:30 p.m., Monday through Friday. FOR FURTHER INFORMATION CONTACT: Daniel Engeljohn, Ph.D., Executive Associate, Policy Analysis and Formulation, Office of Policy and Program Development, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250-3700; (202) 205-0495. SUPPLEMENTARY INFORMATION: Background BSE is a slowly progressing, fatal degenerative disease that affects the central nervous system (CNS) of cattle. BSE belongs to the family of diseases known as the transmissible spongiform encephalopathies (TSEs), which include scrapie in sheep and goats, chronic wasting disease (CWD) in deer and elk, and Creutzfeldt-Jakob Disease (CJD) in humans. In 1996, following outbreaks of BSE in cattle in the United Kingdom, scientists found a possible link between BSE and a new variant of CJD, commonly referred to as variant CJD (vCJD). While it is not certain how BSE may be spread to humans, evidence indicates that humans may acquire vCJD by consuming parts of cattle that contain the BSE agent. The U.S government has taken a number of actions to prevent the spread of BSE into the U.S. Since 1989, the USDA's Animal and Plant Health Inspection Service (APHIS) has prohibited the importation of live cattle and certain animal products from cattle, including rendered protein products, from the United Kingdom and certain other countries where BSE is known to exist. In 1997, because of concerns about widespread risk factors and inadequate surveillance for BSE in many European countries, these importation restrictions were extended to include all of the countries in Europe. As of December 7, 2000, APHIS has prohibited all imports of rendered animal protein products, regardless of species, from BSE-restricted countries because of concerns that feed intended for cattle may have been cross-contaminated with the BSE agent. APHIS leads an ongoing, comprehensive, interagency surveillance system for BSE in the U.S. and, in cooperation with FSIS, has drafted an emergency response plan to be used in the event that BSE is identified in the U.S. BSE was, in fact, identified in a cow in Washington State on December 23, 2003; as a result, the plan was immediately put into effect. Other Federal agencies also have contingency plans that work in concert with the USDA plan. In 1997, the Food and Drug Administration (FDA) issued a final rule prohibiting the use of most mammalian protein in animal feeds for cattle and other ruminants. Under the FDA's rule, animal feed manufacturers must keep records sufficient to track any material that contains prohibited protein (prohibited material) throughout its receipt, processing, and distribution, must have processes in place to prevent co-mingling between ruminant feed and non-ruminant feed containing prohibited materials, and must ensure that non-ruminant feed containing prohibited materials is labeled conspicuously with the statement ``Do not feed to cattle and other ruminants.'' These regulations are intended to prevent the spread of BSE in U.S. cattle through feed contaminated with the BSE agent. In addition, the Centers for Disease Control and Prevention (CDC) leads a surveillance program for vCJD in the U.S. On November 30, 2001, the USDA released the results of a risk assessment on BSE conducted by the Harvard Center for Risk Analysis that evaluates the ways BSE could spread in the U.S. (Ref. 1, available for viewing by the public in the FSIS Docket room and on the Internet at http://www.fsis.usda.gov/OA/topics/bse.htm). The Harvard study also provides government agencies with a science-based approach to evaluate measures already in place to prevent the spread of BSE into the U.S. and to identify additional actions that should be taken to minimize the risk of BSE. The Harvard study shows that early prevention systems put into place by the USDA and the Department of Health and Human Services (HHS) would prevent BSE from spreading throughout the country. Although the Harvard study found that the U.S. was highly resistant to the spread of BSE, as previously mentioned, the USDA response to BSE has always been proactive and preventive. Therefore, in response to the Harvard study, on November 30, 2001, the Secretary of Agriculture announced a series of actions that the Department would take to strengthen its BSE prevention programs and to maintain the government's vigilance against the spread of BSE. One of these actions was to issue a proposed rule to prohibit the use of certain stunning devices used to immobilize cattle during slaughter. This action was identified because certain methods used to stun cattle (i.e., render them unconscious before they are slaughtered) have been found to force visible pieces of CNS tissue, known as macro-emboli, into the circulatory system of stunned cattle. Most of the infectivity in cattle that have BSE is found in the CNS tissue, i.e., brain and spinal cord. Stunning and the Humane Methods of Slaughter Act Section 3(b) of the Federal Meat Inspection Act (FMIA) (21 U.S.C. 603(b)) requires that any cattle or other livestock species slaughtered or handled in connection with slaughter under Federal inspection be handled in accordance with the provisions of the Humane Methods of Slaughter Act (HMSA) (7 U.S.C. 1901-1906). The HMSA states that ``* * * it is * * * the policy of the United States that the slaughtering of livestock and the handling of livestock in connection with slaughter shall be carried out only by humane methods'' (7 U.S.C. 1901). The HMSA requires that livestock be rendered insensible to pain before being shackled, hoisted, thrown, cast, or cut (unless they are slaughtered and handled in connection with slaughter in accordance with certain specified religious ritual requirements) (7 U.S.C. 1902, 1906). The HMSA also authorizes the Secretary of Agriculture (and FSIS by delegation) to designate methods of slaughter and handling in connection with slaughter that conform to the policy of the HMSA (7 U.S.C. 1904(b)). Pursuant to the authority granted under the HMSA, FSIS promulgated regulations that prescribe requirements for the humane treatment of livestock. These regulations, which are codified at 9 CFR part 313, identify, among other things, humane methods of stunning for specified livestock species (see 9 CFR 313.5, 9 CFR 313.15, 9 CFR 313.30). 9 CFR 313.15 sets forth the requirements for the use of captive bolt stunning for livestock. There are two types of captive bolt stunners, penetrative and non-penetrative. Both are permitted to be used to stun cattle prior to bleeding. In addition, the FSIS post-mortem inspection regulations, at 9 CFR 310.13, specifically list air-injection captive bolt stunning as an approved method for injecting air into the carcasses or parts of carcasses of livestock (9 CFR 310.13(a)(2)(iv)(C)). [[Page 1887]] Most slaughter establishments use penetrative captive bolt stun guns to render cattle unconscious, quickly and painlessly prior to slaughter. Penetrative captive bolt stun guns have steel bolts, powered by either compressed air or a blank cartridge. The bolt is driven into the animal's brain. In the past, captive bolt stun guns were often built or modified to inject compressed air into the cranium of cattle, so as to disrupt the brain structures and induce total and prolonged unconsciousness, to ensure that cattle were slaughtered in a humane manner. Studies have shown that penetrative captive bolt stunners that incorporate air-injection can force visible pieces of brain and other CNS tissue into the circulatory system of stunned cattle. These studies are discussed in greater detail below. The regulations in 9 CFR 313.15 do not distinguish among the different types of penetrative captive bolt stunners, such as those that inject air into the cranium of the animal and those that do not. Both methods of stunning are considered to be humane, and both are permitted to be used on cattle. Thus, under the regulations, captive bolt stunners that do not inject air can be used to slaughter cattle humanely. Summary of Studies on Stunning Methods The frequency with which CNS tissue enters the circulatory system of stunned cattle and the size of the CNS tissue emboli depend on the method of stunning used. Fragments of CNS tissue that can be detected visually are referred to as CNS macro-emboli, while pieces of CNS tissue that can only be detected microscopically or with the use of CNS tissue markers are referred to as micro-emboli. Studies have found that when air-injection pneumatic stunners are used, CNS tissue emboli can be identified visually in the pulmonary artery and in the right ventricle of the heart and microscopically in the jugular venous blood (Refs. 2-4, available for viewing by the public in the FSIS Docket Room). Air-injection pneumatic stunning has also been found to result in a high incidence of visually observed blood clots in the right ventricle of the heart (Ref. 3, available for viewing by the public in the FSIS Docket Room). Other types of penetrative captive bolt stunners besides those that use air injection include pneumatically operated stunners that do not inject air and standard cartridge-fired captive bolt stunners. One study found that both pneumatically operated stunners that do not inject air and cartridge fired captive bolt stunners resulted in visually detectable blood clots in the right ventricle of the heart, although only a small number of blood clots were observed when a cartridge fired captive bolt was used (Ref. 3, available for viewing by the public in the FSIS Docket Room). The observation of visible blood clots cannot be used as direct evidence of the presence of CNS tissue; however, the presence of visible blood clots does indicate some type of interference with blood flow through the heart. The blood clots observed in the study were not analyzed for the presence of CNS tissue. More studies are needed to determine whether, and if so, the degree to which, CNS tissue may be present in blood clots observed in the heart of stunned cattle. In general, studies have not demonstrated that penetrative captive bolt stunning without air injection results in CNS tissue macro-emboli in the blood or other tissues of stunned cattle. One study detected no visible or microscopic fragments of brain tissue in jugular venous blood of cattle when a penetrative captive bolt without air injection was used (Ref. 4, available for viewing by the public in the FSIS Docket Room). This same study found no evidence of CNS tissue in jugular venous blood using assays for CNS markers. Another study did not detect CNS tissue in the lungs of cattle by gross examination or by histopathology of selected areas of the lung when captive bolt stunning without air-injection was used (Ref. 5, available for viewing by the public in the FSIS docket room). However, there is one study in which the presence of CNS tissue markers was weakly detected by assay of emboli found in the lungs after cattle were stunned using a penetrative captive bolt without air injection (Ref. 6, available for viewing by the public in the FSIS docket room). The authors of this study concluded that the results suggest that the contamination of the lung with CNS tissue after using a conventional cartridge-fired captive bolt stunner can not be excluded; however, the incidence appears to be very low. The authors also concluded that the presumed CNS tissue emboli, if present at all, are microscopically small. Although not documented in the published studies, in addition to the heart and lungs, FSIS inspection program personnel have reported observing CNS tissue macro-emboli in the liver and kidney of cattle stunned with pneumatic powered air-injection stunners. The Agency has photographs and histopathology reports documenting the presence of CNS tissue macro-emboli when hearts, lungs, livers, and kidneys from cattle stunned using air-injection devices are dissected.\1\ --------------------------------------------------------------------------- \1\ These are available for viewing by the public in the FSIS docket room. --------------------------------------------------------------------------- Risk Considerations 1. European Scientific Steering Committee Opinion The European Commission's (EC) Scientific Steering Committee (SSC) adopted an opinion on Stunning Methods and BSE Risks at its January 10- 11, 2002, meeting that, among other things, describes the tissues and organs that are at risk of being contaminated with CNS material when certain stunning methods are used on certain ruminants (Ref. 7, available for viewing by the public in the FSIS Docket Room). In the opinion, the SSC ranks these stunning methods according to the risk and possible level of CNS tissue contamination. The opinion was based on a scientific report prepared by the EC's TSE/BSE ad hoc Group (Ref. 8, available for viewing by the public in the FSIS Docket Room). The stunning methods addressed in the SSC report include: pneumatic stunner that injects air, pneumatic stunner that does not inject air, captive bolt stunner with pithing, captive bolt stunner without pithing, non- penetrative stunner, and electro-narcosis. Pithing is the insertion of an elongated rod-shaped instrument into the cranial cavity of a stunned animal to further lacerate the CNS tissue. This stunning method is banned by the E.U. and has never been used in the U.S. The SSC concluded that if brain damage occurs during any type of penetrative stunning, and CNS particles are disseminated into the blood, the tissues and organs likely to be contaminated with CNS tissue are, in decreasing order of risk, the blood, pulmonary arteries and lung, and right atrium and ventricles of the heart. The SSC also concluded that the risk of CNS tissue contamination of any other tissue as a result of penetrative stunning was absent or negligible. However, in its report, the EC's TSE/BSE ad hoc committee noted that little data is available to determine whether CNS tissue emboli can occur in a homogenized form or just as structured tissue fragments. As stated in the report, it could be that homogenized CNS tissue may be able to enter arterial circulation and spread to other tissues, including spleen and muscle. There is one study in which marker bacteria placed on a captive bolt pistol was recovered from the spleen, and marker bacteria placed on a pithing rod was found in both [[Page 1888]] spleen and muscle (Ref. 9, available for viewing by the public in the FSIS Docket Room). In its opinion on stunning methods, the SSC ranked the various stunning methods used at slaughter in the E.U. according to the risk for contamination of other tissues with CNS tissue and the possible level of contamination. Of the stunning methods evaluated, the SSC concluded that pneumatic stunners that inject air present the highest risk of brain damage and dissemination of CNS tissue to other tissues and organs, followed by pneumatic stunning without air injection, captive bolt stunning with pithing, and captive bolt stunning without pithing. The SSC found that non-penetrative stunning methods and electro-narcosis present a negligible risk of causing CNS tissue emboli. According to the TSE/BSE ad hoc committee report, there is no accurate estimate of the size range of CNS emboli that occurs as a result of certain stunning methods or of the level of the BSE agent in the CNS tissues of animals incubating the disease. However, the report does state that `` * * * it is clearly evident that if visible CNS material is found * * * it is clear that if this tissue was TSE- infected the organ in which it resides presents a TSE risk.'' Thus, based on the conclusions of the TSE/BSE ad hoc committee, FSIS has determined that methods of stunning that cause contamination of tissues and organs with visible CNS tissue macro-emboli are the methods most likely to present a risk of exposing humans to the agent that causes BSE if used on an animal that has BSE. The SSC noted that any risk to consumers from contamination of tissues and organs with CNS tissue depends on the level of BSE infectivity in the brain of the stunned animal. Thus, the importance of the stunning methods used becomes irrelevant if cattle brains can be assumed to be free of the BSE agent, which, according to the SSC, would be the case for all cattle under one year of age regardless of the country or origin. Furthermore, the SSC determined that when applied to cattle below 30 months of age from any country, stunning methods other than stunning with a pneumatic gun that injects air under pressure, or any stunning methods accompanied by pithing, are likely to result in a much lower or no significant risk of contamination with the BSE agent. 2. The Harvard Risk Assessment's Evaluation of Stunning Methods The Harvard risk assessment model has two stunning methods built in, standard captive bolt stunning and captive bolt stunning with air- injection (Ref. 1, available for viewing by the public in the FSIS docket room and on the Internet at http://www.fsis.usda.gov/OA/topics/bse.htm ). The Harvard study does not differentiate between pneumatic powered captive bolt stunners without air-injection and cartridge fired captive bolt stunners without air-injection. In the risk assessment, Harvard estimates the probability that each method will result in CNS tissue emboli contamination of certain bovine tissues and organs, and the degree to which contamination might occur. In its model, Harvard assumes that if a stunning method results in CNS tissue emboli, the blood, heart, lungs, and liver may be contaminated. Harvard estimates that for each BSE-infected animal stunned with a standard captive bolt stunner (without air injection) there is a 50 percent probability that a very small fraction of the BSE agent will be transferred to the blood. This small fraction of the BSE agent is what would be contained within micro-emboli that might occur. Harvard also estimates that for each BSE-infected animal stunned with a captive bolt stunner that uses air-injection, there is a 31 percent, 16 percent, 3 percent, and 0.6 percent probability that a fraction of the BSE agent will transfer to the blood, heart, lung, and liver, respectively. The probability and amount of the BSE agent transferred varies, with the greatest fraction in the blood, a lower fraction in the heart and lungs, and the lowest in the liver. Harvard found that stunners that use air-injection have a potential to fail on occasion, which results in an increase in CNS tissue emboli formation. Thus, in its risk assessment model, Harvard estimates that when a BSE infected animal is stunned with a malfunctioning captive bolt stunner that uses air-injection, the probability of BSE agent transfer occurring can be approximately 10 times higher for the lung and liver, twice as high for the heart, and 50 percent higher for the blood. Harvard estimated that the amount of BSE agent transferred to these tissues would be approximately ten times higher than the amount transferred with a working air-injection stunner. When evaluating the potential impact that stunning methods may have on the introduction and spread of BSE in the U.S., for its ``base case'' scenario Harvard assumes that air-injection stunning is not used in the U.S., and for its ``worst case'' scenario Harvard assumes that air-injection stunning is used 15 percent of the time. The base case is based upon the present state of the U.S. cattle population, and the existing government regulations and prevailing agricultural practices. When the base case scenario is compared with the worst case scenario, and it is assumed that ten BSE-infected cattle have been introduced into the U.S. system, the number of cattle ID50s that would be potentially available for human exposure increases from 35 to 41 or approximately 17 percent. A cattle oral ID50 is the amount of BSE infectious tissue that would on average cause 50 percent of cattle exposed to develop BSE. Although the Harvard study found that the stunning method used is not a major potential source of human exposure to cattle ID50s, it still found that the number of cattle ID50s available for human exposure would increase with greater use of air- injection stunning. Prohibition of Air-Injection Stunning When developing this rule, FSIS reviewed the published studies on stunning methods and CNS tissue emboli to determine which stunning methods that have been used on cattle in the U.S. are likely to result in CNS tissue macro-emboli. The collective findings of the studies indicate that the only stunning technique that has been used in the U.S. that conclusively results in CNS tissue macro-emboli when used to stun cattle is pneumatic-powered captive bolt stunning with air injection. Furthermore, the findings of the Harvard study on BSE and the SSC Opinion on Stunning Methods and BSE Risks, indicate that, of all the stunning devices used on cattle in the U.S., pneumatic-powered captive bolt stunners that inject air present the highest risk of exposing humans to the BSE agent. Prohibiting the use of air-injection stunning for cattle in the U.S. is consistent with many international stunning requirements for cattle. For example, the E.U. prohibits the use of air-injection stunning for cattle for its member countries.\2\ The E.U. also prohibits the importation of meat products from cattle from the U.S., as well as many other countries, that have been stunned using air- injection.\3\ Canada also prohibits the use of air-injection stunning for cattle.\4\ Thus, [[Page 1889]] prohibiting the use of air-injection stunning for cattle in the U.S. would help to ensure that U.S. establishments that export beef products to foreign countries are not using air injection stunning, which could promote trade with certain countries. --------------------------------------------------------------------------- \2\ Council Directive 93/119/EC, 22 December, 1993 (Official Journal L 340, 31/12/1993., p. 21). \3\ Commission Regulation (EC) No. 999/2001, 22 May 2001, as amended by Regulation (EC) No. 270/2002 14 February 2002 (Official Journal L. 045, 15/02/2002. p. 13-14). \4\ Meat Hygiene Directive 2002-21, April 8, 2002. --------------------------------------------------------------------------- Meat products exported from another country to the U.S. must meet all safety standards applied to meat food products produced in the U.S. Once this rule is in effect, foreign establishments that use air- injection stunning for cattle would be prohibited from importing beef products into the U.S. Thus, prohibiting the use of air-injection stunning in the U.S. would also address the potential risk associated with imported beef products produced from cattle stunned using air- injection. As noted in the E.U. SSC report on Stunning Methods and BSE Risks, there are relatively few studies on stunning techniques and CNS tissue emboli, and the methods used in the studies that have been done are inconsistent. Thus, if further studies indicate that stunning techniques used in the U.S. other than air-injection stunning result in CNS tissue macro-emboli, the Agency will consider prohibiting the use of other stunning techniques as well. FSIS' authority to prohibit the use of captive bolt stunning devices that inject air into the cranium of cattle derives from the FMIA (21 U.S.C. 601(m), 621). When air-injection stunners cause CNS tissue to become dislodged from the brains of cattle, the circulatory systems of the stunned cattle become contaminated with visible CNS macro-emboli. As noted in the E.U. SSC report and the Harvard study, this condition could promote the spread of the BSE agent in the carcass if the animal were infected with BSE because CNS tissue macro-emboli that contain the BSE agent could become lodged in other, edible tissues or organs. FSIS believes that it should not wait until BSE is detected in this country before putting in place appropriate prophylactic measures. By prohibiting the use of air-injection stunning for cattle, FSIS seeks to eliminate a foreseeable source of risk. This action is necessary to strengthen the U.S. Government's BSE prevention efforts. Emergency Action Given the fact that a cow in Washington State tested as positive for BSE on December 23, 2003, it is necessary to issue this rule on an emergency basis. BSE infectivity has been confirmed in the brain, eyes, trigeminal ganglia, tonsils, spinal cord, dorsal root ganglia, and distal ileum. Furthermore, most of these tissues have demonstrated infectivity before experimentally infected animals developed clinical signs of disease. Thus, BSE infectivity in these tissues is not readily ascertainable. Therefore, FSIS has determined that it must take immediate action to ensure that materials that could present a significant risk to human health in beef, as a consequence of stunning practices, are prohibited. Under these circumstances, the FSIS Administrator has determined that prior notice and opportunity for public comment are contrary to the public interest, and that there is good cause under 5 U.S.C. 553 for making this rule effective less than 30 days after publication in the Federal Register. FSIS will consider comments received during the comment period for this interim rule (see DATES above). After the comment period closes, the Agency will publish another document in the Federal Register. The document will include a discussion of any comments received in response to this interim rule and any amendments made as a result of those comments. Executive Order 12866 and Regulatory Flexibility Act This interim final rule has been determined to be significant as defined in Executive Order 12866, and therefore, it has been reviewed by the Office of Management and Budget. FSIS is not aware of any cattle slaughter establishments that use air-injection stunning. Therefore, there appear to be no immediate quantifiable costs or benefits associated with this action. However, since research has shown that the practice poses a risk of exposing humans to materials that could contain the BSE agent, and because the technology was used in the U.S. as recently as the 1990's, FSIS believes that this prohibition is a necessary action to help strengthen the U.S. Government's BSE prevention programs. FSIS has conducted two separate surveys on the use of air injection stunning in official U.S. cattle slaughter establishments. The first survey was conducted from late 1999 to early 2000 and was limited to 72 cattle slaughter establishments located in two FSIS Districts. The second survey was conducted from May 2002 to October, 2002 and involved 270 establishments that slaughter cattle nationwide. Neither of these surveys detected the use of air-injection stunning devices on cattle in official U.S. cattle slaughter establishments. In addition, in July 2002, the seventeen veterinarians in charge of verifying humane slaughter practices in U.S. slaughter plants reported to FSIS headquarters that that they knew of no beef slaughter establishments that use air-injection stunning. Under section 301 of the FMIA, States are permitted to operate their own meat inspection programs provided that State requirements are at least equal to those imposed by the Federal government (21 U.S.C. 661). Meat products produced under State inspection may only be sold within the State. Thus, when it becomes effective, this rule could impact state-inspected establishments that still use air-injection stunning on cattle. However, FSIS is not aware of any state-inspected plants that use this method of stunning. In November 2002, FSIS conducted an informal survey of State officials on the use of air- injection stunners in state-inspected cattle slaughter establishments. The survey detected no state-inspected establishments that were using air-injection stunning on cattle. FSIS is aware of only two companies that have sold air-injection stunning equipment to cattle slaughter establishments in the U.S. One of these companies informed the Agency that it no longer manufactures air-injection stunners, and that in the U.S. it had replaced existing stunners with ones that do not use air injection, at its own cost in the late 1990's. The other manufacturer told FSIS that, although it still produces air-injection stunners, it does not sell any in the U.S. and is in the process of phasing out production of these devices. The E.U. and Canada ban air-injection stunning of cattle and prohibit the importation of beef made from cattle stunned in this manner. Thus, U.S. cattle slaughter establishments that export beef products to these countries already can not use air-injection stunners on those cattle whose products are intended for export. Meat products exported from another country to the U.S. must meet all safety standards applied to food produced in the U.S. Thus, any foreign establishments that export meat products to the U.S. that use air-injection stunning on cattle may incur costs to replace or modify air-injection stunners or be prohibited from exporting beef products to the U.S. In 2000, approximately 87 percent of the beef and veal imported into the U.S. (fresh and frozen) came from Australia, New Zealand, and Canada; approximately 10 percent from Argentina, Brazil, and Uruguay; and approximately 3 percent from Costa Rica, Honduras, Mexico, and Nicaragua (Ref 10, available for viewing by the public in the FSIS Docket Room). [[Page 1890]] As previously mentioned, Canada already prohibits the use of air injection stunners on cattle. Therefore, this rule would have no impact on Canadian establishments that export beef to the U.S. Although Australian law does not ban the use of air-injection stunning, to be used in Australia, any new stunning system must be approved by the Australian Quarantine and Inspection Service (AQUIS). There have been trials of low pressure air injection stunning in Australia. However, AQUIS has not approved any of these devices for general use. Furthermore, an AQUIS official informed FSIS that there is a high degree of awareness among both the regulators and the industry in Australia about the potential problems with this type of stunning. It is unlikely that its introduction in Australia will be sought. New Zealand food safety laws do not allow for the use of air-injection stunning. Both stunning manufacturers that have reported selling air- injection stunning equipment in the U.S. in the past, also have reported that they have sold air-injection stunning equipment to cattle slaughter establishments in South America, and one of them still sells air-injection stunning equipment to cattle slaughter establishments in Mexico, South America, and Eastern Europe. However, FSIS international auditors have not detected the use of air-injection stunners during audits of cattle slaughter establishments in Mexico and South America over the past three years, and the U.S. imports very little, if any, beef products from Eastern Europe. The Agency is continuing to gather data on the international use of air-injection stunning. For those establishments, if any, that are using air-injection stunning, based on conversations with stunning equipment manufacturers, FSIS estimates that the cost of modifying or replacing an individual piece of equipment could range from $1,500.00 to $2,000.00. Regulatory Flexibility Act The Administrator, FSIS, has determined that this rule will not have a significant economic impact, as defined by the Regulatory Flexibility Act (5 U.S.C. 601), on a substantial number of small entities. As discussed above, FSIS is not aware of any cattle slaughter establishments that use air-injection stunning, regardless of the size of the establishment. Thus, it is likely that this rule will have no economic impact on entities of any size. Any small firms that are using air-injection stunning on cattle would incur costs to replace or modify the equipment, which, as stated above, are estimated to range from $1,500.00 to $2,000.00 per piece of equipment. Alternatives Considered FSIS announced its plan to prohibit the use of air-injection stunning of cattle in its current thinking paper on BSE, made available to the public on January 17, 2002 (67 FR 2399, Ref. 11 available for viewing by the public in the FSIS docket room and on the Internet at http://www.fsis.usda.gov/OA/topics/BSE_thinking.htm). Thus, although generally the Agency neither promotes nor bans specific types of technology used for meat and poultry slaughter, the regulatory approach adopted with this action of prohibiting air-injection stunners is consistent with earlier statements made by the Agency. In its BSE current thinking paper, FSIS requested comments on the policy options discussed in the document and received no comments that opposed banning the use of air-injection stunners on cattle. In addition to the approach that was adopted, the Agency considered the alternative of establishing a performance standard that stunning equipment would be required to meet to be used on cattle, and the alternative of no rulemaking. Under the first option, the Agency would have developed a CNS tissue emboli performance standard that stunners would be required to meet to be permitted to be used on cattle. The benefits of this option are that it is more consistent with FSIS regulatory policy than banning a specific technology, and that it would prevent all methods of stunning that do not comply with the performance standard from being used on cattle, not just air-injection stunning. Thus, this option would prevent the need to regulate individual pieces of equipment. A potential problem with this option is that there are relatively few studies on stunning methods and CNS tissue emboli. Thus, the Agency was concerned that if it were to establish a CNS tissue emboli performance standard for cattle stunning devices at this time, further studies could reveal that the performance standard selected does not achieve the result intended by the Agency. Therefore, FSIS decided to prohibit the use of the stunning method that all available studies do conclude result in CNS tissue macro-emboli, i.e., stunning that uses air-injection. Establishing a CNS tissue emboli performance standard would also be more difficult to enforce than the option that was chosen because inspectors would be required to verify that the performance standard was being met. Ensuring compliance with a CNS tissue emboli performance standard could involve analysis of blood or tissue samples for CNS tissue, either by the Agency or the establishment. On the other hand, enforcing a ban on air-injection stunners would simply involve visual verification that a certain piece of equipment is not being used. Thus, enforcement of a performance standard would require more resources than enforcement of an outright ban on air-injection stunners. FSIS rejected the option of no rulemaking because, as previously mentioned, USDA action with regard to BSE has been, and should continue to be, proactive and preventive. Thus, the Agency is taking this action to strengthen its BSE prevention programs. Furthermore, the Agency has already publicized its intention to prohibit the use of air-injection stunning on cattle. There have been no developments with regard to this issue that justify a change in this position. FSIS chose the option of prohibiting the use of air-injection stunning for cattle because the Harvard risk assessment and other recent studies indicate that of all the stunning devices that have been used on cattle in the U.S., pneumatic-powered captive bolt stunners that inject compressed air present the highest risk of exposing humans to bovine CNS tissue. Furthermore, unlike a performance standard, this option also clearly establishes which stunning methods would be prohibited, and it is easy to enforce. In addition, an outright prohibition on air-injection stunning is consistent with international laws and policies that did not allow the use of specific stunning technologies, such as air-injection. Executive Order 12988 This interim final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This interim final rule: (1) Preempts State and local laws and regulations that are inconsistent with this rule: (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule. However, the administrative procedures specified in 9 CFR 306.5 must be exhausted before any judicial challenge of the application of the provisions of this rule, if the challenge involves any decision of an FSIS employee relating to inspection services provided under the FMIA. [[Page 1891]] Paperwork Requirements There are no paperwork or recordkeeping requirements associated with this direct final rule under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Public Notification and Request for Data Public awareness of all segments of rulemaking and policy development is important. Consequently, in an effort to better ensure that minorities, women, and persons with disabilities are aware of this direct final, FSIS will announce it and make copies of this Federal Register publication available through the FSIS Constituent Update. FSIS provides a weekly Constituent Update, which is communicated via Listserv, a free e-mail subscription service. In addition, the update is available on-line through the FSIS Web page located at http://www.fsis.usda.gov. The update is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, recalls, and any other types of information that could affect or would be of interest to our constituents/stakeholders. The constituent Listserv consists of industry, trade, and farm groups, consumer interest groups, allied health professionals, scientific professionals, and other individuals that have requested to be included. Through the Listserv and Web page, FSIS is able to provide information to a much broader, more diverse audience. For more information contact the Congressional and Public Affairs Office, at (202) 720-9113. To be added to the free e-mail subscription service (Listserv), go to the ``Constituent Update'' page on the FSIS Web site at http://www.fsis.usda.gov/oa/update/update.htm. Click on the ``Subscribe to the Constituent Update Listserv'' link, then fill out and submit the form. References The following sources are referred to in this document. All have been placed on display in the FSIS Docket Room (address above) and may be seen by interested persons between 8:30 a.m. and 4:30 p.m., Monday through Friday. 1. Harvard Center for Risk Analysis, Harvard School of Public Health, and Center for Computational Epidemiology, College of Veterinary Medicine, Tuskegee University, November 26, 2001. Evaluation of the Potential for Bovine Spongiform Encephalopathy in the United States. 2. Garland, T., Bauer, N., Bailey, M., 1996. Brain emboli in the lung of cattle after stunning. The Lancet, 348:610. 3. Schmidt, G.R., Hossner, K.E., Yemm, R.S., Gould, D.H., 1999. Potential for disruption of central nervous system tissue in beef cattle by different types of captive bolt stunners, J. Food Prot., 62:390-393. 4. Anil, M.H., Love, S., Williams, S., Shand, A., McKinstry, J.L., Helps, C.R., Waterman-Pearson, A., Seghatchian, J., and Harbour, D.A., 1999. Potential contamination of beef carcasses with brain tissue at slaughter. Vet. Rec., 145: 460-462. 5. Munro, R. 1997. Neural tissue emboli in cattle. Vet. Rec., 145:356. 6. Horlacher, S., Lucker, E., Eigenbrodt, E., Wenisch, S., 2002. ZNS-Emboli in der Rinderlunge (Brain emboli in the lungs of cattle). Berl Munch Tierarztl Wochenschr Jan-Feb; 115(1-2):1-5. 7. E.C. (European Commission), 2002. Opinion of 10-11 January 2002 of the Scientific Steering Committee on Stunning Methods and BSE Risks (The Risk of Dissemination of Brain Particles into the Blood and Carcass When Applying Certain Stunning Methods). 8. E.C. (European Commission), 2001. Report on Stunning Methods and BSE Risks (The Risk of Dissemination of Brain Particles into the Blood and Carcass When Applying Certain Stunning Methods). Prepared by the TSE BSE Ad Hoc Group at its meeting of 13 December 2001. 9. Mackey, B.M, and Derrick, C.M., 1979. Contamination of the deep tissues of carcasses by bacteria present on the slaughter instruments on in the gut. J. Appl. Bact., 46:355-366. 10. USDA Agricultural Statistics, 2002, VII-44, Table 7-70. 11. Food Safety and Inspection Service (FSIS), Current Thinking On Measures That Could Be Implemented To Minimize Human Exposure To Materials That Could Potentially Contain the Bovine Spongiform Encephalopathy Agent, January 15, 2002. Available on the internet at http://www.fsis.usda.gov/OA/topics/BSE_thinking.htm. List of Subjects 9 CFR Part 310 Animal diseases, Meat inspection. 9 CFR Part 313 Animal welfare, Livestock, Meat inspection. 0 For the reasons discussed in the preamble, FSIS amends 9 CFR chapter III as follows: PART 310--POST-MORTEM INSPECTION 0 1. The authority citation for part 310 continues to read as follows: Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53. Sec. 310.13 [Amended] 0 2. Section 310.13 is amended as follows: Paragraph (a)(2)(iv)(C) is amended by adding the phrase ``of all livestock except cattle'' after ``into the skull'' and before ``in conjunction with''. PART 313--HUMANE SLAUGHTER OF LIVESTOCK 0 1. The authority citation for part 313 continues to read as follows: Authority: 7 U.S.C. 1901-1906; 21 U.S.C. 601-695; 7 CFR 2.17, 2.55. Sec. 313.15 [Amended] 0 2. Section 313.15 is amended as follows: Paragraph (b)(2) is amended by revising the paragraph heading, designating the text as paragraph (b)(2)(i), and by adding a new paragraph (b)(2)(ii). The added and revised text reads as follows: Sec. 313.15 Mechanical; captive bolt. * * * * * (b) * * * (2) Special requirements and prohibitions. * * * * * (ii) Captive bolt stunners that deliberately inject compressed air into the cranium at the end of the penetration cycle shall not be used to stun cattle. Done at Washington, DC, on: January 7, 2004. Garry L. McKee, Administrator. [FR Doc. 04-624 Filed 1-8-04; 1:43 pm] ----------------------------------------------------------------------- [Federal Register: January 12, 2004 (Volume 69, Number 7)] [Notices] [Page 1892] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr12ja04-135] [[Page 1892]] ----------------------------------------------------------------------- DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service [Docket No. 03-048N] Bovine Spongiform Encephalopathy Surveillance Program AGENCY: Food Safety and Inspection Service, USDA. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing that it will no longer pass and apply the mark of inspection to the carcasses and parts from cattle that are selected for testing by USDA's Animal and Plant Health Inspection Service (APHIS) for Bovine Spongiform Encephalopathy (BSE) until the sample is determined to be negative. FOR FURTHER INFORMATION CONTACT: Daniel L. Engeljohn, Ph.D., Executive Associate, Office of Policy and Program Development, Food Safety and Inspection Service, 1400 Independence Avenue SW., Washington, DC 20250- 3700; (202) 205-0495. SUPPLEMENTARY INFORMATION: The mission of the U.S. Department of Agriculture (USDA) is to enhance the quality of life for the American people by ensuring a safe, affordable, nutritious, and accessible food supply. APHIS is responsible for ensuring animals and plant health. FSIS is responsible for protecting the Nation's meat, poultry, and egg products supply, making sure it is safe, wholesome, not adulterated, and properly labeled and packaged. These two agencies lead USDA's program activities for prevention, monitoring, and control of bovine spongiform encephalopathy (BSE) in cattle and in the U.S. food supply. BSE, widely referred to as ``mad cow disease,'' is a chronic degenerative disease affecting the central nervous system (CNS) of cattle. To prevent the entry into commerce of meat and meat food products that are adulterated, FSIS inspection program personnel perform ante- and post-mortem inspection of cattle that are slaughtered in the United States. As part of the ante-mortem inspection, FSIS inspection program personnel look for symptoms of disease, including signs of CNS impairment. Cattle showing symptoms of certain diseases, including those exhibiting signs of neurologic impairment, are condemned, and the meat from these animals is not permitted for use as human food. The brains from cattle exhibiting signs of neurologic impairment are submitted to USDA's National Veterinary Services Laboratories for analysis. APHIS veterinarians also randomly collect brain samples from cattle that are believed to be at higher risk of BSE, including cattle older than 30 months and non-ambulatory cattle, as well as from other cattle that do not exhibit signs of neurologic impairment to be tested for BSE. Until recently, unless otherwise prohibited by an FSIS Veterinary Medical Officer, the meat from these animals was allowed to be processed for human food before the BSE sample results were received by FSIS and the establishment. FSIS recommended, but did not require, that slaughter establishments hold these carcasses until the sample results had been received. On December 23, 2003, APHIS diagnosed a presumptive-positive case of BSE in the brain of an adult Holstein cow in the State of Washington. This brain had been sampled by APHIS as part of its surveillance sampling program. On December 25, 2003, the International Reference Laboratory in Weybridge, England confirmed the diagnosis of BSE. In light of this finding, FSIS has concluded that, when APHIS takes a surveillance sample, it would be prudent for FSIS inspection program personnel not to apply the mark of inspection until the result from the APHIS testing is received by FSIS and the establishment, and the result is negative. Accordingly, FSIS will no longer allow these carcasses to be marked ``Inspected and passed'' until the sample testing has been completed, and the result is negative. FSIS is issuing a Directive to its inspection program personnel that sets out this course of action. Additional Public Notification Public awareness of all segments of rulemaking and policy development is important. Consequently, in an effort to better ensure that minorities, women, and persons with disabilities are aware of this notice, FSIS will announce it and make copies of this Federal Register publication available through the FSIS Constituent Update. FSIS provides a weekly Constituent Update, which is communicated via Listserv, a free e-mail subscription service. In addition, the update is available on-line through the FSIS web page located at http://www.fsis.usda.gov. The update is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, recalls, and any other types of information that could affect or would be of interest to our constituents/stakeholders. The constituent Listserv consists of industry, trade, and farm groups, consumer interest groups, allied health professionals, scientific professionals, and other individuals that have requested to be included. Through the Listserv and web page, FSIS is able to provide information to a much broader, more diverse audience. For more information contact the Congressional and Public Affairs Office, at (202) 720-9113. To be added to the free e-mail subscription service (Listserv) go to the ``Constituent Update'' page on the FSIS Web site at http://www.fsis.usda.gov/oa/update/update.htm. Click on the ``Subscribe to the Constituent Update Listserv'' link, then fill out and submit the form. Done at Washington, DC on January 7, 2004. Garry L. McKee, Administrator. [FR Doc. 04-627 Filed 1-8-04; 1:43 pm] -----------------------------------------------------------------------