RULES and REGULATIONS

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 309, 310, and 318

[Docket No. 03-025F]

RIN 0583-AC88

Prohibition of the Use of Specified Risk Materials for Human Food and Requirements for the Disposition of Non-Ambulatory Disabled Cattle; Prohibition of the Use of Certain Stunning Devices Used To Immobilize Cattle During Slaughter

Friday, July 13, 2007

AGENCY: Food Safety and Inspection Service, USDA.

*38700 ACTION: Affirmation of interim final rules with amendments.

SUMMARY: The Food Safety and Inspection Service (FSIS) is affirming, with changes, the interim final rule "Prohibition of the Use of Specified Risk Materials for Human Food and Requirements for the Disposition of Non-Ambulatory Cattle," which was published in the Federal Register on January 12, 2004. The Agency is also affirming the interim final rule "Prohibition of the Use of Certain Stunning Devices Used to Immobilize Cattle During Slaughter," also published on January 12, 2004. FSIS issued these interim final rules in response to the confirmation on December 23, 2003, of bovine spongiform encephalopathy (BSE) in an imported dairy cow in Washington State. FSIS is taking this action to make permanent interim measures implemented by the Agency to minimize human exposure to cattle materials that could potentially contain the BSE agent.

DATES: This final rule is effective October 1, 2007. Comments on the information presented under "Paperwork Reduction Act" must be received by September 11, 2007.

FOR FURTHER INFORMATION CONTACT: Dr. Daniel Engeljohn, Deputy Assistant Administrator, Office of Policy, Program, and Employee Development, FSIS, U.S. Department of Agriculture, 1400 Independence Avenue, SW., Washington, DC 20250- 3700, (202) 205-0495.

SUPPLEMENTARY INFORMATION:

Background

On January 12, 2004, FSIS issued a series of three interim final rules to minimize human exposure to materials that scientific studies have demonstrated have the potential to contain the BSE agent in cattle infected with that disease. Scientific and epidemiological studies have linked the human disease variant Cruetzfelt-Jacob Disease (vCJD) to exposure to BSE, most likely through human consumption of beef products contaminated with the BSE agent. FSIS issued the rules in response to the diagnosis on December 23, 2003, of BSE in an imported dairy cow in Washington State. The animal had been imported from Canada.

One of the rules, "Prohibition of the Use of Specified Risk Materials for Human Food and Requirements for the Disposition of Non-ambulatory Disabled Cattle" (69 FR 1862, January 12, 2004) (also referred to as "the SRM interim final rule"), designates certain materials from cattle as specified risk materials (SRMs), declares that SRMs are inedible, and prohibits the use of these materials for human food (9 CFR 310.22(a) and 9 CFR 310.22(b)). The SRM interim final rule also requires 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 and incorporate these procedures into their HACCP plans or Sanitation Standard Operating Procedures (SOPs) or other prerequisite programs (9 CFR 310.22(d)).

The materials identified as SRMs in the FSIS SRM interim final rule 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 dorsal root ganglia (DRG) from cattle 30 months of age and older, and the distal ileum of the small intestine and tonsils from all cattle (9 CFR 310.22(a)). The SRM interim final rule declares that SRMs are inedible because they present a sufficient risk of exposing humans to the BSE agent so as to render them "unfit for human food" within the meaning of section 1(m)(3) of the adulteration provisions of the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601(m)(3)).

The SRM interim final rule designates the distal ileum from all cattle as an SRM because BSE infectivity has been confirmed in the distal ileum in the early stages of the disease. To ensure effective removal of the distal ileum, the SRM interim final rule originally required that the entire small intestine be removed and disposed of as inedible. However, in the preamble to the SRM interim final rule, FSIS noted that beef processors may be able to effectively remove the distal ileum from the rest of the small intestine and requested comments on this issue (69 FR 1862, 1869). The Agency again requested comments on this issue in an advance notice of proposed rulemaking published in July 2004 ("Federal Measures To Mitigate BSE Risks: Considerations for Further Action" (69 FR 42287, 42296)).

In response to these requests, FSIS received several comments that described detailed procedures on how to remove the distal ileum from the small intestine. On the basis of these comments, FSIS evaluated this issue and determined that processors have the technology to effectively remove the distal ileum from the rest of the small intestine. Therefore, on September 7, 2005, FSIS issued an amendment to the SRM interim final rule to permit, under specific conditions, the use of beef small intestine, excluding the distal ileum, for human food (70 FR 53043).

In addition to prohibiting SRMs for use as human food, the SRM interim final rule also prohibits the slaughter for human food of non-ambulatory disabled cattle that are offered for slaughter. FSIS prohibited the slaughter of these non-ambulatory disabled cattle because surveillance data from European countries in which BSE has been detected indicate that non-ambulatory cattle are among the cattle that have a greater incidence of BSE than healthy slaughter cattle. Furthermore, because the typical clinical signs of BSE often cannot be distinguished from the typical clinical signs of other diseases and conditions that affect non-ambulatory cattle, FSIS determined that non-ambulatory disabled cattle present a sufficient risk of introducing the BSE agent into the human food supply so as to render the carcasses of these animals unfit for human food under section 1(m)(3) of the FMIA. The SRM interim final rule requires that all non-ambulatory disabled cattle that are offered for slaughter be condemned (9 CFR 309.3(e)).

In addition to the SRM interim final rule, FSIS published two other interim final rules in response to the confirmation of BSE in the cow in Washington State. One of the rules, Prohibition of the Use of Certain Stunning Devices Used to Immobilize Cattle During Slaughter (69 FR 1885) (also referred to as "the air-injection stunning interim final rule"), prohibits the use of captive bolt stunning devices that deliberately inject air into the cranial cavity of cattle. The other rule, "Meat Produced by Advanced Meat/Bone Separation Machinery and Meat Recovery (AMR) Systems" (69 FR 1874) (also referred to as "the AMR interim final rule"), establishes requirements for meat produced using AMR systems. In this document, FSIS is affirming *38701 without amendment the air-injection stunning interim final rule. Because the AMR interim final rule contains several non-BSE related provisions, FSIS intends to affirm and, if necessary, amend that interim final rule in a separate document that will be published in the Federal Register at a later date.

Since FSIS issued the SRM, AMR, and air-injection stunning interim final rules, the Agency has implemented a number of programs to train its inspection personnel and help plants comply with new requirements. FSIS has issued several notices to its inspection personnel that detail specific aspects of the regulations, including BSE surveillance activities in cooperation with USDA's Animal and Plant Health Inspection Service (APHIS). In 2004, FSIS held five teaching workshops around the country to help primarily small and very small plants understand the regulations and help ensure compliance. As part of a continuing outreach effort to small and very small plants, FSIS produced workshop training materials, which remain available on the FSIS Web site. Additionally, FSIS developed a training CD and accompanying materials called "The ABC's of BSE," which were released as part of FSIS' distance learning program.

FSIS is confident it is successfully carrying out its mission to protect public health by strictly enforcing safeguards designed to protect Americans from BSE. FSIS will continuously evaluate its policies and procedures to ensure that they remain based on the most up-to-date science available.

Since FSIS issued the interim final rules described above, two native cases of BSE have been confirmed in the United States. In June 2005, the disease was confirmed in a 12 year-old cow born and raised on a ranch in Texas. In March 2006, a second case was confirmed in a cow on a farm in Alabama. Experts confirmed through dentition that this animal was at least 10 years old. Both animals were born before the Food and Drug Administration (FDA) issued its 1997 prohibition on the feeding of most mammalian protein to ruminants.

Opportunities To Comment

When it issued the interim final rules described above, FSIS gave the public until April 12, 2004, to submit comments on the rules. The comment period was later extended to May 7, 2004 (69 FR 18245, April 7, 2004). In addition, on July 14, 2004, APHIS, FSIS, and FDA issued an Advance Notice of Proposed Rulemaking (ANPR), "Federal Measures To Mitigate BSE Risks: Considerations for Further Action," (also referred to as "the APHIS/FSIS/FDA ANPR") that provided another opportunity for interested parties to comment on certain issues raised in the SRM interim final rule (69 FR 42287). The comment period for the APHIS/FSIS/FDA ANPR closed on September 13, 2004. In addition, when FSIS amended the SRM interim final rule to permit the use of beef small intestine, excluding the distal ileum, for human food, it gave the public until November 7, 2005, to comment on the issues raised in that rulemaking (70 FR 53043).

In developing this final rule to affirm the SRM and air-injection stunning interim final rules, FSIS considered all comments received in response to the documents described above. Based on its continued analysis of the issues, and on information provided by comments, FSIS has made certain changes to the SRM interim final rule. Those changes are summarized below and are discussed in detail in the Agency's responses to comments. As noted above, FSIS is affirming the interim provisions of the air-injection stunning interim final rule without amendment.

Summary of Amendments to SRM Interim Final Rule

In this final rule, FSIS is affirming the provisions in the SRM interim final rule and, in addition, is amending the rule to:

• Clarify that non-ambulatory disabled cattle that are offered for slaughter must be condemned but that FSIS inspection personnel will determine on a case-by-case basis the disposition of cattle that become non-ambulatory after they have passed ante-mortem inspection;

• Clarify that veal calves that are unable to rise from a recumbent position because they are tired or cold may be set apart and held for treatment;

• Exclude from the definition of SRMs materials from cattle from countries that can demonstrate that their BSE risk status can reasonably be expected to provide the same level of protection from human exposure to the BSE agent as prohibiting SRMs for use as human food does in the United States;

• Require that the spinal cord from cattle 30 months of age and older be removed from the carcass at the establishment where the animal was slaughtered;

• Clarify that an establishment's procedure for the removal, segregation, and disposition of SRMs must address potential contamination of edible materials with SRMs before, during, and after entry into the official establishment;

• Codify requirements for the sanitation of equipment used to cut through SRMs; and

• Specify the conditions under which slaughter establishments may ship carcasses or parts of carcasses that contain vertebral columns from cattle 30 months of age and older to another federally-inspected establishment for further processing.

Comments and Responses

FSIS received approximately 23,000 comments in response to the January 2004 interim final rules, the APHIS/FSIS/FDA ANPR, and the September 2005 amendment to the SRM interim final rule. Among the commenters were dairy farmers, cattle producers, meat processors, importers and exporters of meat products and by-products, members of Congress, representatives of State governments, representatives of foreign governments, organizations that represent livestock producers, organizations that represent meat processors, consumer advocacy organizations, animal welfare advocacy organizations, members of the restaurant industry, members of the academic community, private consultants, and private citizens. Most of the comments were submitted by animal welfare organizations and citizens concerned about the welfare of animals. Approximately 150 comments were submitted by entities other than animal welfare organizations or citizens concerned about the welfare of animals. The following are the issues raised by the comments and FSIS' response.

Prohibition on the Slaughter of Non-Ambulatory Disabled Cattle

Comment: Most of the comments received in response to the SRM interim final rule supported the prohibition on the slaughter of non-ambulatory disabled cattle for human food. Some of these comments stated that such a prohibition is needed to prevent human exposure to the BSE agent. These comments were from members of the restaurant industry, consumer advocacy organizations, animal welfare organizations, and a private consultant. Most supported the prohibition because, as described in the preamble to the SRM interim final rule, surveillance data from the European Union indicate that cattle that cannot rise from a recumbent position are among the cattle that have a greater incidence of BSE than healthy slaughter cattle. One comment noted that non-ambulatory cattle accounted for over half of the detected BSE cases *38702 in both the European Union and Switzerland in 2003. The comment included references to support this statement.

Many comments also supported the prohibition on the slaughter of non-ambulatory cattle because the typical clinical signs of BSE may not always be observed in a non-ambulatory animal. According to the comments, determining the reason that an animal is non-ambulatory is often extremely difficult, if not impossible, without a full diagnostic work-up. One comment noted that neurological, metabolic, or other diseases that affect coordination and other aspects of gait often predispose an animal to injuries, such as broken limbs or soft tissue damage. The comment stated that if an animal is non-ambulatory because of a broken leg or torn ligament, the injury may be the prominent or sole presenting sign. The comment asserted that, without a complete diagnostic work-up and history of disease progression, the true underlying cause of the non-ambulatory condition may be impossible to ascertain.

This same comment also included a list of clinical signs of BSE from the United Kingdom's Department for Environment, Food, and Rural Affairs (DEFRA) Web site. The comment observed that the vast majority of signs (apprehensiveness; nervousness; reluctance to cross concrete, turn corners, enter yards, go through doorways, or permit milking; occasional kicking when milked; head shyness; high stepping gait, particularly hind legs; difficulties in rising; tremors; loss of condition, weight, or milk yield) would be difficult, if not impossible, to observe in a non-ambulatory animal.

Some comments argued that the previous system of clinical examination of non-ambulatory disabled cattle is not adequate to determine the disposition of cattle with regard to BSE. The comments asserted that when the SRM interim rule was issued, both cases of BSE that had been detected in North America at that point were non-ambulatory cattle that had been observed by veterinarians prior to slaughter, and neither had been identified as a BSE clinical suspect.

One comment stated that although the objective of the prohibition on the slaughter of non-ambulatory disabled cattle for human food is to minimize human exposure to the BSE agent, such a measure may also safeguard against other foodborne diseases, drug residues, and bioterrorism.

Most comments that opposed the prohibition on the slaughter of non-ambulatory disabled cattle asserted that prohibiting the slaughter of all non-ambulatory cattle for human food is overly broad and not necessary to protect the public. These comments were submitted by individual farmers, cattle producers, custom slaughter operations, small meat processors, trade associations that represent cattle producers, trade associations that represent meat processors, and State Departments of Agriculture.

One comment argued that the provisions in the SRM interim final rule associated with non-ambulatory disabled cattle do not take into consideration the basis for the animal's non-ambulatory status or the risk mitigation measures implemented by the U.S. government to prevent the spread of the BSE agent in the U.S. human and cattle populations. Several comments stated that the fact that an animal cannot rise from a recumbent position or walk does not necessarily render its carcass unfit for human food. Some of the comments argued that otherwise healthy cattle that are non-ambulatory solely due to an acute injury, such as a broken leg or torn ligament, are no more likely to test positive for BSE than healthy slaughter cattle. These comments asserted that the carcasses of these cattle pose little risk of exposing humans to the BSE agent.

Some comments stated that Federal and state veterinarians are able to readily discern through ante-mortem or post-mortem inspection whether an animal has suffered an acute injury or is affected with a pathological condition. One comment submitted detailed guidance on establishing the clinical signs consistent with cattle suspected of having BSE. According to the comment, the guidance was developed by veterinarians that have extensive experience dealing with cattle with confirmed BSE. The comment stated that while these veterinarians noted that the clinical signs of BSE are subtle, the document establishes clear and objective guidelines for determining clinical risk factors.

One comment noted that, although the SRM interim final rule cited epidemiological data from the European Union that suggests that animals that generally fit the description of "non-ambulatory" are among the animals most likely to test positive for BSE, there remain significant differences among countries concerning the definition of this class of cattle. As an example, the comment provided BSE surveillance data from Switzerland that indicates that there was no difference between the BSE prevalence rate of cattle in the "sick slaughter" category and those from the general "healthy population" within the Swiss cattle herd in 2002. The comment also noted that the Swiss study cited in the SRM interim final rule that demonstrates an increased likelihood of detecting BSE in targeted testing of fallen stock and emergency-slaughtered animals compared to the general population of healthy animals only looked at cattle over 24 months of age.

Some comments recommended that FSIS limit the prohibition on the slaughter of non-ambulatory disabled cattle to the specific subgroup of cattle that are most likely to present a higher risk of testing positive for BSE. According to the comments, these would be cattle that are 30 months of age and older whose non-ambulatory status cannot be attributed to an acute injury. Many of these comments suggested that FSIS allow non-ambulatory disabled cattle younger than 30 months that are unable to rise or walk due to an acute injury to be used for human food if the animal passes ante-mortem inspection and the carcass passes post-mortem inspection.

In addition to the comments described above, on July 7, 2005, the Humane Society of the United States, Farm Sanctuary, and a private citizen petitioned FSIS to take action to issue a final rule to prohibit the slaughter of non-ambulatory disabled cattle for human food. According to the petition, the confirmation on June 24, 2005, of a second case of BSE in a non-ambulatory animal in the United States demonstrates that the issuance of a final rule to prohibit the slaughter of these animals cannot be delayed any further. The petition asserted that FSIS should promptly issue a permanent ban on the slaughter of non-ambulatory disabled cattle to ensure that the U.S food supply is safe, export markets for beef remain open, and animals are treated in a humane and compassionate manner.

Response: After careful consideration of this issue and the comments received in response to the SRM interim final rule, FSIS has decided to affirm the prohibition on the slaughter of non-ambulatory disabled cattle offered for slaughter for human food. As discussed in the preamble to the SRM interim final rule, surveillance data from the European Union indicate that cattle that cannot rise from a recumbent position are among the cattle that have a greater prevalence of BSE than healthy slaughter cattle and the typical clinical signs of BSE may not always be observed when cattle are non-ambulatory.

As noted by some of the comments, the clinical signs of BSE are often subtle, and many typical signs, such as *38703 gait disturbances, can only be observed in an animal that is able to rise from a recumbent position and walk. FSIS agrees that if an animal with clinical BSE is non-ambulatory due to an acute injury, such as a broken leg or torn ligament, the injury may be the prominent or sole presenting sign. Furthermore, the fact that there have been confirmed cases of BSE in North America in non-ambulatory cattle that had been observed by veterinarians prior to slaughter that had not been identified as BSE clinical suspects provides evidence that the underlying reason for an animal's non-ambulatory condition cannot always be accurately ascertained when these animals are presented for slaughter.

As noted by one comment, the non-ambulatory disabled cattle that are more likely to test positive for BSE may differ depending on how a particular country defines this class of animals. However, to minimize the risk that clinical signs of BSE may not be observed in non-ambulatory cattle, FSIS is affirming the SRM interim final rule's definition of non-ambulatory disabled livestock 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.

This final rule affirms the requirement that non-ambulatory disabled cattle offered for slaughter be condemned but also clarifies that FSIS inspection personnel will determine on a case-by-case basis the disposition of cattle that become non-ambulatory after they have passed ante-mortem inspection. This amendment reflects current Agency practice as described in FSIS Notice 5-04, "Interim Guidance for Non-Ambulatory Disabled Cattle and Age Determination" (originally issued January 12, 2004, extension of effective date January 17, 2006) and FSIS Notice 05-06, "Re-Examination of Bovine that become Non-Ambulatory after Passing Ante-Mortem Inspection" (January 18, 2006)).

FSIS Notices 5-04 and 05-06 instruct FSIS PHVs on the actions they are to take when cattle become non-ambulatory after they have passed ante-mortem inspection. These notices provide that FSIS PHVs are to permit cattle that have passed ante-mortem inspection but that become non-ambulatory prior to slaughter from an acute injury to proceed to slaughter and post-mortem inspection if the PHV can verify that the animal suffered an acute injury. Under FSIS Notice 05-06, PHVs are to tag these cattle as "U.S. suspects." If PHVs cannot verify that an animal that has passed ante-mortem inspection but that becomes non-ambulatory prior to slaughter suffered an acute injury, FSIS Notice 05-06 instructs the PHV to tag the animal as "U.S. condemned."

While FSIS agrees that non-ambulatory cattle younger than 30 months are less likely to present a risk of introducing the BSE agent into the human food supply than non-ambulatory disabled cattle that are 30 months of age and older, as explained in the preamble to the SRM interim final rule, although rare, there have been instances in which BSE has been confirmed in cattle younger than 30 months. Thus, FSIS has determined that it is prudent to continue to require the condemnation of cattle that exhibit some type of clinical abnormality that could be consistent with the end stages of BSE, regardless of the age of the animal.

As explained in the final regulatory impact analysis (FRIA) of this final rule, FSIS considered information presented in a recently updated version of the Harvard Risk Assessment (the 2005 model) in making its decision as to which measures are prudent for preventing potential human exposure to the BSE agent. Estimates generated using the 2005 model indicate that removal of SRMs is the most effective measure for preventing human exposure to the BSE agent and that such a measure would reduce, over a 20-year period, human exposure to the BSE agent by 99% from the baseline. The 2005 model also estimates that excluding non-ambulatory cattle from the human food supply would reduce, over a twenty-year period, human exposure to the BSE agent by approximately 3% from the baseline level.

Accordingly, FSIS has decided to affirm the prohibition on the slaughter of non-ambulatory disabled cattle because, as explained above, the typical clinical signs of BSE cannot always be observed in an animal that cannot rise from a recumbent position or walk, and BSE surveillance data from the European Union indicate that non-ambulatory disabled cattle are among the cattle sub-populations that have demonstrated the highest prevalence of BSE in countries where BSE has been identified. As discussed in the preamble to the SRM interim final rule, certain materials from cattle infected with BSE have demonstrated BSE infectivity a few months before the onset of clinical disease. Thus, it is not always possible to identify on ante-mortem inspection those cattle that are approaching the end stages of disease, which is when levels of the BSE agent are the highest. However, the Agency has determined that continuing to require the condemnation of cattle that exhibit some type of clinical abnormality that could be consistent with the end stages of BSE will reduce the potential for materials with infectious levels of the BSE agent to be introduced into the human food supply through the inadvertent contamination of edible tissue with SRMS.

Thus, after considering the available data on BSE and non-ambulatory disabled cattle, FSIS has determined that requiring the condemnation of these animals when they are offered for slaughter continues to be a prudent measure to prevent potential human exposure to the BSE agent.

Comment: Many comments argued that the prohibition on the slaughter of non-ambulatory disabled cattle for human food should not apply to non-ambulatory disabled cattle slaughtered or processed in custom operations for the owner's exclusive use if the animal is non-ambulatory as the result of an acute injury. Most of these comments were from farmers and owners of custom slaughter operations. Some of the comments suggested that FSIS allow the owner of the animal to present documentation at the time of slaughter to verify that the animal is non-ambulatory because of an acute injury. The comments suggested that this documentation could include an affidavit from a witness to the injury or from a state or local veterinarian that examined the animal shortly after the injury occurred. One comment suggested that the attending veterinarian for the farm where the animal was injured fill out an ante-mortem inspection form to document the reason for the animal's non-ambulatory condition. To ensure that non-ambulatory disabled cattle are non-ambulatory as the result of a recent injury, some comments suggested that FSIS limit the time that is permitted to elapse between the injury and the slaughter of the animal. One comment suggested that this time be limited to 12 hours.

Some comments stated that prohibiting the owners of non-ambulatory disabled cattle from having these animals slaughtered or processed in custom operations for their personal use will result in the slaughter and processing of non-ambulatory disabled cattle on the farm under insanitary conditions and without proper refrigeration, which will create a greater risk to public health than allowing these animals to be slaughtered or their products prepared in custom operations. *38704 Other comments questioned FSIS' ability to enforce the prohibition on the slaughter of non-ambulatory disabled cattle in custom facilities, given that products produced in these facilities are exempt from the inspection requirements of the FMIA.

Some comments questioned FSIS' legal authority to prohibit the slaughter or processing of non-ambulatory disabled cattle in custom facilities for the personal use of the owner of the animal. Most of these comments were submitted by representatives of State Departments of Agriculture. These comments argued that: (1) The term "adulterated" as used in the FMIA only applies to carcasses, parts thereof, meat, and meat food products, and not to live animals that have not received ante-mortem inspection by a government veterinarian; (2) the FMIA exempts the slaughter of livestock and the processing of their carcasses and parts for the personal use of the owner from the inspection requirements of the FMIA; and therefore, (3) animals slaughtered in custom operations cannot be condemned by FSIS because they are not inspected. Some of these comments also asserted that a government prohibition on the slaughter or processing of any animal raised by an individual for his or her own personal use amounts to a seizure of property without just compensation.

Response: FSIS has determined that it cannot permit the custom slaughter or preparation of products of non-ambulatory disabled cattle for human food even if it is for the owner's exclusive use because the Agency considers the carcasses of these animals to be adulterated.

As explained in the background section of this document, when it issued the SRM interim final rule, FSIS determined that non-ambulatory disabled cattle present a sufficient risk of introducing the BSE agent into the human food supply so as to render the carcasses of these animals "unfit for human food" under section 1(m)(3) of the adulteration provisions of the FMIA. To prevent the use of adulterated carcasses for human food, the SRM interim final rule requires that all non-ambulatory disabled cattle offered for slaughter be condemned on ante-mortem inspection (9 CFR 309.3(e)).

Although the custom slaughter and preparation of products of cattle and other livestock are exempt from inspection under section 23(a) of the FMIA, meat and meat food products prepared in custom operations are still subject to the FMIA's adulteration and misbranding provisions (21 U.S.C. 623(a), 21 U.S.C. 623(d)). Thus, while FSIS inspectors are not present in custom facilities to condemn non-ambulatory disabled cattle that are offered for slaughter, custom operators are effectively prohibited from slaughtering or preparing products of non-ambulatory disabled cattle, because the carcasses of these animals are considered unfit for human food.

Therefore, FSIS not only disagrees with the comments that assert that it lacks the legal authority to prohibit the custom slaughter or preparation of products of non-ambulatory disabled cattle, the Agency has concluded that the FMIA requires that the carcasses of these animals be prohibited for human food regardless of whether the animal is slaughtered in a custom operation for the owner's exclusive use or in an official establishment for distribution in commerce.

As discussed above, while this final rule requires that all non-ambulatory disabled cattle that are offered for slaughter be condemned, it also clarifies that FSIS inspection personnel will determine the disposition of cattle that become non-ambulatory after they have passed ante-mortem inspection on a case-by-case basis (9 CFR 309.3(e)). Thus, as explained above, FSIS PHVs may permit cattle that have passed ante-mortem inspection but that become non-ambulatory because of an acute injury prior to slaughter to proceed to slaughter and post-mortem inspection if the PHV can verify that the animal suffered an acute injury.

As noted above, FSIS inspectors are not present in custom operations to examine cattle that become non-ambulatory after they have been offered for slaughter. However, if an animal becomes non-ambulatory from an acute injury after its owner has delivered it to a custom operation for slaughter, the custom operator may slaughter the animal for human food if both the operator and the owner of the animal did not observe any other clinical abnormalities that could be consistent with BSE before the animal sustained the acute injury.

Comment: Some comments suggested that, instead of prohibiting the slaughter of all non-ambulatory disabled cattle, FSIS should require that all non-ambulatory disabled cattle be tested for BSE, and if the test result is negative, the Agency should allow the carcass to be used for human food. The comments noted that FSIS' "test and hold" policy, which requires that the carcasses of cattle tested for BSE be retained until the test results are known, would apply. Some comments stated that FSIS should facilitate the testing of non-ambulatory disabled cattle on the farm and use the results to determine the disposition or marketing of the animal.

Other comments agreed with FSIS' conclusion in the SRM interim final rule that, because of limitations in the available testing methods, testing non-ambulatory cattle for BSE would not provide the same level of protection from human exposure to BSE as excluding non-ambulatory disabled cattle from the human food supply.

Response: FSIS disagrees with the comments that suggested that it should permit non-ambulatory disabled cattle that test negative for BSE to be slaughtered for human food. As was explained in the preamble to the SRM interim final rule, under the BSE tests that are available today, certain tissues of cattle infected with BSE may contain the BSE agent even though the diagnostic test does not indicate that the animal has the disease. Thus, FSIS has determined that the BSE tests that are available today are not appropriate for use as a food safety measure.

Comment: Some comments argued that since SRMs are the only materials in which BSE infectivity has been confirmed, rather than prohibiting the slaughter of non-ambulatory disabled cattle, FSIS should require that all materials that have been designated as SRMs be removed from non-ambulatory disabled cattle regardless of the age of the animal. As stated by the comments, removal of SRMs is the action that has the greatest impact on ensuring that materials that may contain the BSE agent do not enter the human food supply.

Response: Although the BSE agent has only been confirmed in certain materials of cattle infected with BSE, unintentional contamination of edible materials with SRMs could potentially occur during slaughter and processing. As noted above, non-ambulatory disabled cattle are among the cattle that are more likely to test positive for the BSE agent than healthy slaughter cattle. Thus, these animals are more likely to be in the end stages of the disease, which is when infective tissues are known to contain the highest levels of the BSE agent. Therefore, FSIS has determined that requiring the condemnation of cattle that exhibit some type of clinical abnormality that could be consistent with BSE will reduce the potential for materials with infectious levels of the BSE agent to be introduced into the human food supply through the inadvertent contamination of edible tissue with SRMs.

Comment: Some comments stated that the prohibition on the slaughter of non- ambulatory disabled cattle will hamper USDA's surveillance testing for BSE by *38705 removing access to these animals at slaughter establishments.

Response: Experience with APHIS' testing for BSE has demonstrated that this has not been the case. Surveillance for BSE in the United States has always targeted those cattle populations where the disease is most likely to be found. The goal of APHIS' enhanced BSE surveillance program, which began on June 1, 2004, was a one-time effort designed to give a snapshot of the cattle population in the United States and to help define whether BSE is present in the cattle population and, if so, at what level. The program tested as many animals in the targeted population as possible over a 12- to 18-month period. Although there have been fewer non-ambulatory disabled cattle available for testing at official slaughter establishments since FSIS issued the SRM interim final rule, APHIS has increased the number of samples collected from non-ambulatory and other high-risk cattle at farms, slaughter facilities, rendering facilities, livestock auctions, veterinary clinics, and public health laboratories.

As discussed in more detail below, based on the information obtained through both the enhanced surveillance program and the BSE surveillance conducted by the United States in the 5 years before the enhanced surveillance program was implemented, USDA has concluded that the prevalence of BSE in the United States is extremely low. Therefore, in July 2006, USDA's APHIS announced that it would begin transitioning its enhanced BSE surveillance program to an ongoing surveillance program (http://www.aphis.usda.gov/newsroom/hot-- issues/bse/downloads/BSE--ongoing--surv--plan--final--71406.pdf). APHIS' ongoing BSE surveillance program, which samples approximately 40,000 animals each year, continues to sample the cattle populations where the disease is most likely to be found. The targeted population for APHIS' ongoing surveillance includes cattle exhibiting signs of CNS disorders or any other signs that may be associated with BSE, including emaciation or injury, and dead cattle, as well as non-ambulatory cattle. Samples from the targeted population are being taken from the same locations as those used during the enhanced surveillance program.

Comment: A few comments requested that FSIS clarify that the prohibition on the slaughter of non-ambulatory disabled cattle does not apply to veal calves that are unable to stand on arrival at the slaughter establishment because they are tired or cold. The comments stated that FSIS should allow the establishment to rest these animals or warm them up prior to ante-mortem inspection. Other comments stated that cattle that have become non-ambulatory for reasons related to stress or fatigue, and have no other clinical signs associated with BSE, should be given the opportunity to recover from the fatigue to determine if they can become ambulatory.

Response: The prohibition on the slaughter of non-ambulatory disabled cattle applies to all cattle that are offered for slaughter, including veal calves. However, the regulations that prescribe requirements for the disposition of condemned livestock permit livestock condemned on account of certain conditions to be set apart and held for treatment (9 CFR 309.13 (b)). These animals are permitted to proceed through normal slaughter procedures if, following treatment, FSIS inspection personnel find that the condition that required condemnation has resolved.

Since it issued the SRM interim final rule, FSIS has permitted veal calves that cannot stand because they are tired or cold to be set aside for treatment. In this final rule, FSIS is revising 9 CFR 309.13 to clarify that this is an accepted practice. The regulations that prescribe requirements for the disposition of condemned livestock also permit condemned livestock to be released for a purpose other than slaughter if permission is obtained by the local, State, or Federal official that has jurisdiction over the movement of the animal (9 CFR 309.13). Thus, cattle and calves that are unable to stand when they arrive at slaughter may, if permission is obtained, be released from the establishment for treatment.

Comment: Several comments from cattle farmers and ranchers asserted that the prohibition on the slaughter of non-ambulatory disabled cattle has placed a serious economic burden on livestock owners. Many of these comments, particularly those from dairy farmers, stated that prior to the implementation of the new regulations, when a healthy cow suffered an acute injury, farmers were able to send the animal to slaughter and receive compensation for it. According to the comments, as a result of the rule, livestock owners must not only incur a loss when a healthy animal becomes non-ambulatory, but also incur costs associated with destroying the animal and disposing of its carcass.

Several comments from small meat processors and custom operations said that the prohibition on the slaughter of non-ambulatory disabled cattle places a serious economic burden on them. These comments stated that because they do not slaughter or process a large number of animals, they stand to lose a significant source of revenue, and some stated that a prohibition on the slaughter of non-ambulatory disabled cattle will cause them to go out of business.

Response: FSIS acknowledges that prohibiting the slaughter of all non-ambulatory disabled cattle offered for slaughter has certain economic effects on farmers, small meat processors, and custom operators. However, as discussed above, the carcasses of non-ambulatory disabled cattle offered for slaughter are adulterated and as such cannot be used for human food. The final regulatory impact analysis section of this document contains a more complete description of the economic impact of prohibiting the slaughter of non-ambulatory disabled cattle for human food.

Materials Designated as SRMs

Comment: Several comments concurred with the list of materials that FSIS designated as SRMs. Some comments indicated that removal of these materials is supported by the Harvard Risk Assessment.

One comment stated that the 30-month cut-off for exclusion of SRMs provides very strong protection of human health, given that fewer than 0.01% of BSE cases have been recorded in cattle under 30 months of age. The comment also said that in regions such as North America, where BSE is very rare, and where measures to prevent its spread have been in place for a number of years, it is improbable that cattle will be exposed to high doses of the BSE agent. Therefore, the commenter postulates that short incubation periods are unlikely in the United States, which makes a 30-month age cut-off for SRMs adequate and reasonable.

Response: FSIS agrees that the current scientific understanding supports these comments. As explained in more detail below, FSIS is affirming the 30-month age and older classification for certain SRMS.

Comment: Some comments stated that the materials designated as SRMs if they are from cattle 30 months of age and older should be considered SRMs if they are from cattle 12 months of age and older. The comments asserted that the pathogenesis of BSE is not clearly understood, and that there is still scientific uncertainty regarding when during the incubation period infectivity occurs. The comments noted that cattle as young as 21 months have tested positive for BSE in both Japan and the United Kingdom.

*38706 Some of the comments also noted that the post-mortem tests that are available today are only capable of identifying the presence of the BSE agent near the end of the incubation period. As stated by the comments, cattle younger than 30 months of age in the early stages of BSE that do not test positive for the disease may still be harboring the BSE agent.

Some comments argued that permitting the brain or spinal cord from cattle of any age for human food carries an unjustifiable risk of exposing humans to the BSE agent. These comments suggested that FSIS prohibit brain and spinal cord from all cattle for human food.

Response: In the SRM interim final rule, FSIS designated all materials that have demonstrated BSE infectivity as SRMs, regardless of the level or proportion of infectivity contained in each tissue. However, because BSE infectivity has only been confirmed in certain tissues when cattle are approaching the end of the disease incubation period, or after cattle have developed overt clinical disease, FSIS designated some tissues as SRMs only if they are from cattle 30 months of age and older. As discussed in detail in the preamble to the SRM interim final rule and in the APHIS/FSIS/FDA ANPR, the Agency has determined that a 30-month-and-older age classification for certain SRMs is reasonable because BSE surveillance data from European countries demonstrate that cattle younger than 30 months are unlikely to be in the later stages of BSE and, thus, are unlikely to contain high levels of BSE infectivity. Materials that have demonstrated infectivity in the early stages of disease are SRMs regardless of the age of the animal. In addition, prevalence estimates from USDA's APHIS enhanced BSE surveillance program also support the 30 month-and-older age classification for certain SRMs. BSE surveillance data from the European Union and the United States are discussed below.

FSIS is aware of the cases of BSE in animals 21 and 23 months of age reported by Japan mentioned by the comments. FSIS took comment on the significance of these cases. The response to those comments is provided later in the preamble to this final rule. In short, a report issued by the European Food Safety Authority (EFSA), Scientific Panel on Biological Hazards, states that "it is unclear whether the very young cases [reported in Japan] were adequately identified and formally confirmed." [FN1]

FN1 The EFSA Journal 2005 220, 1-21, Annex to the Opinion, Report of the Working Group on the assessment of the age limit in cattle for the removal of certain specified risk materials (SRM) (see 1.2.3. Age distribution of young BSE cases outside the EU, p. 11). Available on the Internet at: http://www.efsa.eu.int/science/biohaz/biohaz--opinions/opinion-- annexes/933/biohaz--report--ej220--srmremove--en1.pdf.

BSE surveillance in the European Union. As discussed in the preamble to the SRM interim final rule and the APHIS/FSIS/FDA ANPR, although rare, BSE has been confirmed in cattle younger than 30 months. As explained in those documents, the occurrence of BSE in young animals is most likely the result of exposure to a high infective dose of the BSE agent at a young age.

BSE surveillance data from the European Union indicate that most cases of BSE detected in animals younger than 30 months involve cattle that were most likely exposed to the BSE agent at a time when their countries-of-origin had significant levels of circulating BSE infectivity. As the level of BSE disease in the European Union has decreased, so has the number of confirmed cases in cattle younger than 30 months. [FN2] This most likely reflects a reduction in the amount of circulating BSE infectivity that occurred after full implementation by most E.U. countries of measures to prevent the spread of BSE.

FN2 European Commission (EC), 2005; Report on the monitoring and testing of ruminants for the presence of transmissible spongiform encephalopathy (TSE) in 2004, European Commission Health and Consumer Protection Directorate-General; European Commission (EC), 2004; Report on the monitoring and testing of ruminants for the presence of transmissible spongiform encephalopathy (TSE) in 2003, European Commission Health and Consumer Protection Directorate-General; European Commission (EC), 2003; Report on the monitoring and testing of ruminants for the presence of transmissible spongiform encephalopathy (TSE) in 2002, European Commission Health and Consumer Protection Directorate-General (http:// europa.eu.int/comm/food/food/biosafety/bse/mthly--reps--en.htm).

These analyses of BSE surveillance data from the European Union indicate that when disease prevalence is low, and effective measures for preventing the spread of BSE are in place, it is unlikely that there will be a sufficient amount of circulating BSE infectivity to result in clinical cases in young animals.

BSE surveillance in the United States. As discussed below, analysis of USDA's APHIS BSE surveillance testing program has led FSIS to conclude that the BSE prevalence in the United States is extremely low. Based on the low estimated prevalence of BSE in the United States, FSIS has determined that U.S. cattle younger than 30 months are unlikely to contain high levels of the BSE agent and that a 30-month-and-older age classification for certain SRMs remains appropriate for the United States.

USDA's APHIS has conducted surveillance for BSE disease since 1990. Surveillance has always targeted those cattle populations where the disease is most likely to be found. The level of surveillance in the United States has increased steadily from 1990 and jumped significantly in 2004 when USDA implemented enhanced surveillance following the detection of BSE in an imported cow in December 2003.

As stated above, the goal of USDA's enhanced BSE surveillance program, which began on June 1, 2004, was to test as many animals in the targeted population as possible over a 12- to 18-month period. This program was designed to provide a snapshot of the domestic cattle population to help define whether BSE is present in the United States and, if so, at what level.

Based on the information gained during both the enhanced surveillance program and the BSE surveillance conducted in the United States in the five years before the enhanced surveillance program was implemented, APHIS recently concluded that the prevalence of the disease in this country is extremely low, less than one case per million adult cattle. Two models were used to estimate the prevalence, and the most likely values calculated by these models estimate that the number of cases is between 4 and 7 infected animals out of 42 million adult cattle. [FN3] APHIS' analysis was submitted to the scrutiny of a peer review process, and the expert panel agreed with the appropriateness of APHIS' assumptions and the factors it considered, as well as with the estimate of BSE prevalence. APHIS has transitioned into an ongoing BSE surveillance program designed to test a targeted sample of approximately 40,000 targeted animals each year, a level consistent with international animal health standards. [FN4]

FN3 "An Estimate of the Prevalence of BSE in the United States," Animal and Plant Health Inspection Service, USDA, July 20, 2006. Available on the Internet at: http://www.aphis.usda.gov/peer--review/content/printable-- version/BSE--Prevalance--scientific--doc--after.pdf.

FN4 OIE Terrestrial Animal Health Code 2006, Appendix 3.8.4, Surveillance for Bovine Spongiform Encephalopathy.

Comment: Some commenters indicated that expanding the list of SRMs to include materials from cattle 12 months of age and older is consistent with recommendations made in a report by an international expert BSE panel (the International Review Team or IRT) that was convened at the request of the *38707 Secretary of Agriculture to review actions taken by the United States in response to a single finding of BSE. The commenters noted that the IRT report recommended that the brain, skull, spinal cord, and vertebral column of all cattle over 12 months be excluded from both the human food and animal food chains unless aggressive surveillance proves the BSE risk in the USA to be minimal according to [former] standards of the World Organization for Animal Health (the OIE). [FN5]

FN5 The OIE guidelines no longer provide for a minimal BSE risk category. Since the IRT issued its report, the OIE has revised its BSE risk categories. OIE now has three BSE risk categories instead of five: negligible risk, controlled risk, and undetermined risk.

Response: As noted by the commenters, the IRT report did recommend that the brain, skull, spinal cord, and vertebral column of all cattle over 12 months be excluded from both the human food and animal food chains unless aggressive surveillance indicates otherwise. However, as discussed above, USDA's APHIS has conducted the aggressive surveillance recommended by the IRT, and the extremely low prevalence estimates, in conjunction with the E.U. experience, provide evidence that a 30-month-and-older age classification for certain SRMs is a prudent measure for preventing human exposure to the BSE agent in the United States. The 30-month-and-older age classification for SRMs that have demonstrated BSE infectivity in the end stages of the disease incubation is accepted internationally in BSE standards set by various countries and is consistent with OIE recommendations.

In addition, FSIS' regulations contain measures that reduce the potential for cattle younger than 30 months to introduce the BSE agent into the human food supply. Under 9 CFR 309.4 of the ante-mortem inspection regulations, all livestock with signs of a neurological disease must be condemned. Thus, the regulations prohibit the slaughter of those cattle younger than 30 months having any characteristics consistent with the end stages of BSE, i.e., those with clinical signs consistent with the disease. Furthermore, the prohibition on the slaughter of non-ambulatory disabled cattle, which FSIS is affirming in this document, ensures that non-ambulatory cattle younger than 30 months that may have clinical signs consistent with BSE that are difficult to observe do not enter the human food supply. Thus, the regulations require the condemnation of all cattle that exhibit some type of clinical abnormality that could be consistent with the end stages of BSE, regardless of the age of the animal.

Comment: One comment noted that a recently published study suggests that there may be another form of transmissible spongiform encephalopathy in cattle, referred to as bovine amyloidotic spongiform encephalopathy (BASE). According to the comment, given the possibility of an additional strain of BSE, together with the continued lack of scientific understanding concerning the pathogenesis of the disease, FSIS must minimize human exposure to all animal materials that could potentially harbor the BSE agent. The comment argued that as long as there is uncertainty, SRMs from cattle over 12 months of age should be excluded from both the human and animal food chain.

Response: There is very little data on the BASE strain of BSE described by the comment. The data that are available do not indicate that cattle with this form of BSE are more likely to contain high levels of the infective agent early in the incubation period than cattle with the "typical" BSE strain. Further study on the BASE form of BSE is needed to determine its significance.

Comment: One comment stated that a ban on SRMs regardless of the age of the animal would significantly improve enforcement of the regulations and would eliminate the need to determine the age of each animal offered for slaughter. Another comment said that the only plausible explanation for not prohibiting SRMs from cattle of all ages is an implicit cost/benefit analysis. According to the comment, the FMIA does not allow the Agency to rely on a cost/benefit analysis. It requires that the Agency remove all adulterated materials from the market.

Response: FSIS disagrees with these comments. With regard to the comment that stated that the FMIA requires that the Agency remove all adulterated materials from the market without consideration of costs or benefits, the SRM interim final rule does require that all adulterated materials be excluded from the human food supply. Under the SRM interim final rule, certain materials are only considered adulterated if they are from cattle 30 months of age and older.

FSIS disagrees that prohibiting materials designated as SRMs for human food regardless of the age of the animal is needed to improve enforcement of the regulations, as was suggested by one of the comments. Under the regulations, establishments must develop, implement, and maintain written procedures to ensure that SRMs are completely removed from the carcass, segregated from edible materials, and disposed of as inedible. FSIS is responsible for ensuring that the establishment's procedures are adequate and effective, and is responsible for taking appropriate action if they are not. As discussed in more detail later in this document, the Agency has developed effective procedures for verifying the age of cattle offered for slaughter.

Comment: One comment noted that in its 2002 "Current Thinking Paper" on BSE, FSIS identified prohibiting the brain and spinal cords from cattle 24 months of age and older for human food, and prohibiting the vertebral column from cattle 24 months of age and older as a source material in mechanical meat recovery systems, as measures that the Agency was considering implementing to minimize potential human exposure to the BSE agent. The comment stated that FSIS must offer some justification as to why the Agency determined that a 30-month age cut-off for SRMs is appropriate in preventing potential human exposure to the BSE agent when it had previously stated that a 24-month age cut-off was necessary to protect public health.

Another comment stated that Germany, Italy, and France test all cattle older than 24 month of age that are slaughtered for human food for BSE. According to the comment, this suggests that these countries have concluded that there is a significant risk that cattle between 24 and 30 months of age may transmit the BSE agent to humans.

Response: FSIS made its "current thinking paper" on BSE available to the public January 17, 2002. The 24-month age cut-off for SRMs as described in that document was based on the best information available at the time and was intended to address the fact that, in rare instances, BSE had been confirmed in cattle younger than 30 months in the European Union. [FN6]

FN6 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 (see page 8). Available on the Internet at http:// www.fsis.usda.gov/oa/topics/bse--thinking.htm.

However, the E.U. BSE surveillance data that were available at the time that FSIS issued the paper were limited because they generally reflected cases detected by means of traditional passive surveillance. [FN7] In January 2001, the European Union implemented more systematic testing for BSE, which has increased the number of BSE cases detected. Thus, more complete *38708 information on the age distribution of confirmed BSE cases has become available since FSIS issued its current thinking paper.

FN7 Frequently asked questions about BSE. 6 April 2001. Europa Web site: http://europa.eu.int/comm/food/fs/bse/bse20--en.html.

The E.U. BSE surveillance data that are available today indicate that BSE is unlikely to be confirmed in animals younger than 30 months in the European Union, which, as explained above, most likely reflects a reduction in the amount of circulating BSE infectivity that occurred after full implementation by most E.U. countries of measures to prevent the spread of BSE. For example, in E.U. BSE surveillance testing conducted in 2002, 2003, and 2004, none of the 4,355 animals that tested positive for BSE were younger than 30 months. [FN8] A total of 31,514,999 BSE tests were conducted in those years. In addition, as discussed above, the extremely low BSE prevalence estimates obtained from APHIS' analysis of its BSE surveillance data reinforce the conclusion that a 30-month-and-older age classification for certain SRMs is a prudent measure for preventing human exposure to the BSE agent as opposed to the 24-month age cut-off that the Agency was contemplating when it issued its current thinking paper.

FN8 European Commission (EC), 2005; Report on the monitoring and testing of ruminants for the presence of transmissible spongiform encephalopathy (TSE) in 2004, European Commission Health and Consumer Protection Directorate-General; European Commission (EC), 2004; Report on the monitoring and testing of ruminants for the presence of transmissible spongiform encephalopathy (TSE) in 2003, European Commission Health and Consumer Protection Directorate-General; European Commission (EC), 2003; Report on the monitoring and testing of ruminants for the presence of transmissible spongiform encephalopathy (TSE) in 2002, European Commission Health and Consumer Protection Directorate-General (http:// europa.eu.int/comm/food/food/biosafety/bse/mthly--reps--en.htm).

As noted by one comment, Germany, Italy, and France require that cattle older than 24 months be tested for BSE if they are slaughtered for human food. However, testing for BSE conducted in these countries from 2001 through 2004 has detected only two animals younger than 30 months of age, and both were detected in 2001. [FN9] Of note is that these animals were 28 and 29 months of age. Furthermore, measures implemented by other European countries appear to recognize that cattle older than 30 months present the greatest risk of introducing the BSE agent into the human food supply. Under the E.U. regulations, cattle over 30 months of age must be tested for BSE if they are slaughtered for human food. [FN10] In addition, since 1996, the United Kingdom has prohibited the slaughter of cattle over 30 months of age for human food. This prohibition was recently replaced with a program that permits cattle over 30 months to be used for human food if these animals test negative for BSE (except for cattle born before August 1, 1996). [FN11] In the United Kingdom and the rest of the European Union, SRMs must still be removed from animals that test negative for BSE.

FN9 European Commission (EC), 2002; Report on the monitoring and testing of ruminants for the presence of transmissible spongiform encephalopathy (TSE) in 2001, European Commission Health and Consumer Protection Directorate-General (http://europa.eu.int/comm/food/food/biosafety/bse/mthly--reps-- bse2001--en.htm).

FN10 Commission Regulation (EC) No 1248/2001 of 22 June 2001 amending Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards epidemio-surveillance and testing of transmissible spongiform encephalopathies.

FN11 United Kingdom, Department for Environment Food and Regulatory Affairs (DEFRA) Web site at http://www.defra.gov.uk/animalh/bse/otm/index.html (accessed November 2005).

Comment: A few comments stated that FSIS should designate bone marrow as an SRM even though pathogenesis studies have not conclusively demonstrated that bone marrow contains BSE infectivity. The comments stated that FSIS should not wait for a "conclusive" study to take action to prevent human exposure to a potential source of BSE infectivity. One comment stated that the FMIA mandates a precautionary approach that does not require conclusive demonstration that a meat food product will cause adverse health effects.

Response: FSIS has reviewed the available research with regard to BSE infectivity in bone marrow and has determined that it does not support designating bone marrow as an SRM.

As noted in the preamble to the SRM interim final rule, in pathogenesis studies conducted in the United Kingdom, bone marrow from one set of cattle demonstrated BSE infectivity 38 months post oral exposure to the BSE agent. [FN12] However, because bone marrow from cattle sacrificed at earlier (32 and 36 months) and later (40 months) intervals post exposure to the BSE agent did not demonstrate infectivity, these findings are considered inconclusive. The infectivity at 38 months was detected through use of a mouse bioassay and occurred after the cattle had developed clinical signs of disease.

FN12 Wells GA, Hawkins DA, Green RB, Spencer YI, Dexter I, Dawson M. 1999, Limited detection of sternal bone marrow infectivity in the clinical phase of experimental Bovine Spongiform Encephalopathy (BSE). Vet Rec. Mar 13: 144 (11): 292-4.

BSE infectivity in bone marrow has also been tested using a more sensitive cattle bioassay. In November 2003, the U.K. Spongiform Encephalopathy Advisory Committee (SEAC) reported that in the cattle bioassay, no infectivity had been reported in bone marrow of cattle up to 55-56 months post exposure to the BSE agent. [FN13] SEAC concluded that research from the cattle bioassay indicate that the level of infectivity in the bone marrow is at most very low, and that the single positive finding from the mouse bioassay may be an experimental artifact but cannot be discounted.

FN13 Eightieth Meeting of the Spongiform Encephalopathy Advisory Committee Meeting, November 2003. Available on the Internet at: www.seac.gov.uk/minutes/final80.pdf.

On the basis of the information on BSE infectivity in bone marrow that is described above, FSIS has concluded that there is insufficient evidence to indicate that bone marrow should be designated as an SRM. FSIS will continue to follow the research with regard to BSE infectivity in bone marrow. However, even if there is weak infectivity in the bone marrow of cattle, it likely presents little risk of exposing humans to the BSE agent because FSIS requires condemnation of the cattle most likely to contain infectivity, i.e., those with clinical signs of disease and non-ambulatory animals.

Comment: Some comments suggested that FSIS prohibit organs in close proximity to SRMs, such as the dura mater, hypophysis, pineal gland, and cerebrospinal fluid, for human food. One comment noted that the dura was harvested but not tested in pathogenesis studies conducted in the United Kingdom. According to the comment, the dura's close association with the brain and spinal cord, along with the documented evidence of its role in the human-to-human transmission of CJD, has prompted scientists to designate bovine dura as a high-risk tissue. The comment also noted that if the dura is not removed and disposed of as inedible prior to processing, it may come loose and be incorporated into ground product or contaminate surfaces where de-boning occurs.

Response: FSIS agrees that, because of their close association to the CNS, the dura mater and CSF from cattle 30 months of age and older could potentially come in contact with SRMs; contamination could result from such contact if the animal had BSE. While the dura and CSF are not designated as SRMs, establishments are required to address the potential for edible products to become contaminated with SRMs in their procedures for the removal, segregation, and disposition of SRMS.

*38709 Anatomically, the hypophysis and pineal gland are part of the brain and thus must be removed from the carcass when the brain is removed.

Comment: A few comments suggested that FSIS designate bovine spleen and pancreas as SRMs.

Response: Neither the spleen nor pancreas from cattle has demonstrated BSE infectivity, nor are they closely associated with any materials that have been designated as SRMs. Therefore, the spleen and pancreas from cattle are not SRMs.

Comment: One comment stated that FSIS should designate the entire head from cattle 30 months of age and older as SRM and require that the cheek and head meat of cattle 12 months of age and older be removed before the skull is fragmented or split.

Response: The SRM interim final rule designates potentially infective materials, as well as certain materials that are closely associated with potentially infective materials, from cattle 30 months of age and older as SRMs. Furthermore, under the SRM interim final rule, establishments are required to address contamination of all edible materials, which would include head meat, with SRMs in their procedures for the removal, segregation, and disposition of SRMs. Therefore, FSIS has concluded that it is not necessary to designate the entire head from cattle 30 months of age and older as an SRM.

None of the materials located in the head of cattle younger than 30 months of age are considered SRMs. Therefore, FSIS does not believe that it is necessary to prescribe procedures for the removal of head meat from cattle younger than 30 months in order to minimize potential human exposure to the BSE agent.

Comment: One comment stated that FSIS must better articulate its rationale for excluding other areas of the carcass from the list of SRMs. According to the comment, there is scientific evidence to indicate that the BSE agent is not confined to the brain and spinal cords of cattle, and that it can be found in several other compartments and extra-CNS spinal nerve centers. The comment criticized FSIS for not including a discussion on whether peripheral nerves coursing throughout the carcass may potentially contain BSE infectivity.

Response: As discussed in the preamble to the SRM interim final rule, available data on the development and distribution of tissue infectivity in BSE-infected cattle are incomplete, and most of what is known comes from the pathogenesis studies conducted in the United Kingdom (69 FR 1862, 1864, January 12, 2004). When it issued the SRM interim final rule, FSIS noted that while the results of the pathogenesis 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, these studies did not determine the rate at which the BSE agent increases in the tissues that have demonstrated infectivity or identify the tissues that the BSE agent must pass through to reach its ultimate destination. Of the peripheral nervous tissues tested in the pathogenesis studies, only the DRG and trigeminal ganglia demonstrated infectivity, which occurred late in the disease incubation and in cattle with clinical disease.

After FSIS issued the SRM interim final rule, a study in which highly BSE-susceptible transgenic mice challenged with a variety of tissue samples from a clinically diseased cow was published. [FN14] Of the tissues sampled in this study, infectivity was confirmed in the CNS, as well as in the optic nerve and the retina. In addition, samples of the facial and sciatic nerve of the peripheral nervous system (PNS) also demonstrated infectivity, although at lower levels than the CNS tissues. The study also tested tissue samples from the radial nerve of the PNS and reported no demonstrated infectivity at the time of publication.

FN14 Buschmann, A, Groschup, MH. Highly Bovine Spongiform Encephalopahty-Sensitive Transgenic Mice Confirm the Essential Restriction of Infectivity to the Nervous System in Clinically Diseased Cattle. Journal of Infectious Disease, 2005; 192:934-42.

While both the U.K. pathogenesis study and the study involving the highly BSE-susceptible transgenic mouse bioassay described above demonstrate that BSE infectivity may occur in certain PNS tissues of cattle in the end stages of BSE disease, FSIS has determined that these studies do not provide conclusive evidence that peripheral nerves coursing throughout the carcass contain BSE infectivity. In both studies, the PNS tissues that demonstrated BSE infectivity were closely associated with the CNS, and infectivity was only detected in these tissues late in the disease incubation, or when cattle had overt clinical disease. While FSIS acknowledges that these findings do not exclude the possibility that other parts of the PNS may contain infectivity at some point in the course of BSE disease, the Agency believes that the fact that infectivity has only been confirmed in PNS tissues that are closely associated with the CNS indicates that if BSE infectivity does occur in other parts of the PNS, it is most likely at low or undetectable levels.

Thus, based on the available research, FSIS believes that the primary tissues of concern for spreading the BSE agent have been identified. FSIS will continue to follow the results of future studies on BSE to further refine this determination and inform its policies with regard to BSE.

Comment: Several comments requested that FSIS continue to designate the spinal cord and DRG from cattle 30 months of age and older as SRMs but remove the vertebral column from the list of materials designated as SRMs. The comments stated that designation of vertebral column as SRM because of its proximity to the DRG is not scientifically justifiable. The comments asserted that technologies can be developed to effectively remove DRG without requiring removal of the vertebral column. One comment stated that the regulatory intent of designating the vertebral column as SRM can be achieved by designating spinal cord and DRG as SRMs and adding the following sentence: "Unless the establishment can demonstrate through scientific methods that the spinal cord and DRG have been completely removed, the entire vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum) shall be removed."

Response: While the comments submitted on this issue suggested that technologies can be developed to remove the DRG without requiring removal of certain parts of the vertebral column, they did not provide any evidence to demonstrate that such technologies exist or how establishments would accomplish removal of DRG without removing sections of the vertebral column. Therefore, under this final rule, 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 is among the materials designated as SRM. The Agency will reconsider this issue if this technology becomes available.

Comment: Some comments stated that vertebral bones should not be SRMs if they are part of a bone-in cut of meat. According to one comment, establishments should already have or, if they do not, could easily implement procedures for the thorough removal of the spinal cord and sheath from the vertebral column. The comment stated that the remaining DRG are contained within the vertebral bones and as such are not likely to be consumed by *38710 humans unless they are processed using AMR technology. As noted by the comment, another regulation issued by FSIS, i.e., the AMR interim final rule, prohibits the use of vertebral columns from cattle 30 months of age and older in the production of AMR product. The comment stated that allowing vertebral bones from cattle 30 months of age and older to remain in traditional cuts, like T-bone steaks, will not result in any increased risk of consumer exposure to the BSE agent.

Some comments stated that requiring the removal of the vertebral column from cattle 30 months of age and older imposes costs on farmers and small processors and has raised consumer satisfaction issues. One comment noted that the United Kingdom lifted its ban on bone-in beef because scientists concluded that the potential risk of human exposure to the BSE agent from bone-in beef was insignificant.

Response: FSIS disagrees that vertebral bones should not be SRMs if they are part of a bone-in cut of meat. As noted by the comments, most establishments have the technology to completely remove the spinal cord from the vertebral column, but FSIS is not aware of any that have the technology to remove the DRG without removing parts of the vertebral column.

Although the DRG are located within the vertebral bones, FSIS has determined that because they could potentially become dislodged during consumption of bone-in beef products, the DRG from cattle 30 months of age and older are still a potential source of human exposure to the BSE agent. An updated risk assessment conducted for USDA by the Harvard Center for Risk Analysis (the 2005 Harvard model) determined that consumption of bone-in-beef could account for 23% of the total potential human exposure to the BSE agent on average (based on the conditions as they existed in 2003 and assuming the introduction of 10 infected cows). [FN15] The 2005 Harvard BSE Update assumes that the total infectivity in bone-in-beef is the sum of the contribution of spinal cord contained in these cuts of meat and the DRG attached to the bones.

FN15 Harvard Center for Risk Analysis, " Harvard Risk Assessment of Bovine Spongiform Encephalopathy Phase IA.," 2005. Available for viewing by the public in the FSIS docket room and on the FSIS Web site at: http:// www.fsis.usda.gov/Science/Risk--Assessments/index.asp#bse.

With regard to the comment that the United Kingdom has lifted its bone-in-beef ban, the United Kingdom does not permit for use as human food bone-in-beef derived from parts of the vertebral column that have been designated as SRMs. The vertebral column (excluding the vertebrae of the tail, the spinous and transverse processes of the cervical, thoracic and lumbar vertebrae and the median sacral crest, the wings of the sacrum, but including the DRG) from cattle over 24 months is considered an SRM in the United Kingdom. [FN16]

FN16 United Kingdom Food Standards Agency (FSA) 2005, Web site http:// www.food.gov.uk/bse/what/beef/controls.

Comment: Comments submitted on whether FSIS should require that the entire small intestine be removed to ensure effective removal of the distal ileum were addressed in the amendment to the SRM interim final rule issued on September 7, 2005 (70 FR 53043). FSIS received seven comments in response to the amended interim final rule. Most were supportive of the Agency's decision to permit the use of beef small intestine, excluding the distal ileum, for human food. Some asserted that FSIS only considered comments submitted by the casing and meat processing industry.

Response: FSIS in fact carefully considered all comments on removal of the distal ileum that were submitted in response to the SRM interim final rule and the APHIS/FSIS/FDA ANPR and addressed the issues raised by the comments in the September 7, 2005 amendment to the SRM interim final rule (see 70 FR 53043).

Comment: Since FSIS issued the amendment to the SRM interim final rule that permits, under certain conditions, beef small intestine, excluding the distal ileum, for use as human food, establishments interested in harvesting the small intestine for human food have requested that the Agency clarify whether procedures that involve removal of the small intestine without uncoiling it comply with the requirements of the rule if the establishment can verify that, when it is uncoiled, the part of the small intestine that is not harvested for human food measures at least 80 inches from where the distal ileum attaches to the cecum.

Response: 9 CFR 310.22(a)(3)(ii) of the amended SRM interim final rule provides that the small intestine may be used for human food if the distal ileum is removed by a procedure that removes at least 80 inches of the uncoiled and trimmed small intestine as measured from the ceco-colic junction and progressing proximally towards the jejunum or by a procedure that the establishment demonstrates is effective in ensuring complete removal of the distal ileum. Procedures in which the small intestine is harvested without uncoiling it are likely to comply with 9 CFR 310.22(a)(3)(ii) if the establishment can verify that when it is uncoiled, the portion of the intestine that was not harvested for human food measures at least 80 inches from the ceco-colic junction progressing proximally towards the jejunum.

Requirements for the Removal, Segregation, and Disposition of SRMs

Comment: Some comments stated that FSIS should prescribe specific procedures for the removal, segregation, and disposition of SRMs rather than rely on private industry to implement appropriate procedures that will best achieve the requirements of the interim final rule. One comment stated that in the interim final rule, FSIS did not specify who would approve the procedures for the removal, segregation, and disposition of SRMs in the establishment's HACCP plan or Sanitation SOP.

Response: As noted in the preamble to the SRM interim final rule, FSIS did not prescribe specific procedures for the removal, segregation, and disposition of SRMs because the Agency believes that establishments should have the flexibility to implement the most appropriate procedures that will best achieve the requirements of the rule. The regulations recognize that procedures that are appropriate for some establishments to ensure that SRMs are completely removed from the carcass, segregated from edible materials, and disposed of as inedible may not be effective when used in other establishments. Therefore, FSIS disagrees that it should prescribe specific procedures for the removal, segregation, and disposition of SRMs.

While FSIS does not approve an establishment's procedures for the removal, segregation, and disposition of SRMs, the Agency is responsible for ensuring that these procedures are adequate and effective. If FSIS inspection personnel determine that an establishment's procedures are not effective in excluding SRMs from the human food supply, the Agency will take appropriate action.

Comment: One comment suggested that FSIS require that establishments address SRMs in their HACCP plans, and that the Agency create a regulatory sampling program to verify that edible portions of carcasses are not contaminated with SRMs. The comment stated that the program could be similar to the testing program required for establishments that use AMR technology.

Response: The regulations require that establishments address SRMs as part of their food safety systems, i.e., in their *38711 HACCP plans or Sanitation SOPs or other prerequisite programs. To ensure that SRMs are not present in meat products, FSIS inspection personnel verify that establishments are removing SRMs in a manner that does not result in contamination of edible tissues. Unlike AMR products, gross contamination of beef carcasses and solid cuts of meat with SRMs can often be detected visually. Therefore, FSIS has determined that it is not necessary to establish a verification sampling program for SRM removal at this time.

Comment: One comment requested that FSIS exclude references to HACCP in 9 CFR 310.22(d)(1) because there is no scientific basis for determining that abnormal prions are a hazard reasonably likely to occur when conducting a hazard analysis. The comment stated that removal of SRMs would be better covered in an establishment's Sanitation SOPs or other prerequisite program.

Response: When conducting a hazard analysis, some establishments may determine that SRMs are a hazard that is reasonably likely to occur and that should be addressed in the HACCP plan. Other establishments may determine that it is more appropriate to address the removal and disposition of SRMs in their Sanitation SOPs or other prerequisite programs. Thus, because FSIS believes that establishments should have the flexibility to implement the most appropriate procedures that will best achieve the requirements of this rule, the Agency is not removing references to HACCP in this final rule.

Comment: Some comments suggested that FSIS prescribe and supervise the methods of destruction for SRMs rather than leave those choices to the producers, slaughterers, or processors. One comment stated that because the rule does not specify how SRM disposal must be accomplished, FSIS cannot assure that once removed, SRMs are consistently disposed of in a manner that will not introduce the BSE agent into the environment. One comment noted that alkaline hydrolysis at elevated temperatures is the most effective and environmentally responsible method of destroying materials that could potentially contain the BSE agent. Another comment stated that FSIS did not evaluate alternative methods of disposition for SRMs or the consequences of each alternative.

Response: The SRM interim final rule requires that SRMs be handled and disposed of in accordance with 9 CFR part 314.1 or 9 CFR 314.3 of FSIS' regulations for the handling and disposition of condemned or other inedible products at official establishments (see 9 CFR part 314). For establishments that have the appropriate facilities, condemned or other inedible carcasses or parts must be disposed of by inedible rendering (also referred to as "tanking") in accordance with the procedure prescribed by 9 CFR 314.1. Under 9 CFR 314.3, those establishments that do not have tanking facilities may dispose of condemned or other inedible carcasses or parts by incineration or by denaturing using crude carbolic acid, cresylic disinfectant a formula consisting of one part DF&C No. 3 green coloring, 40 parts water, 40 parts liquid detergent, and 40 parts oil of citronella, or any other proprietary substance approved by the Administrator.

The purpose of the prescribed methods of disposal of condemned or other inedible carcasses and parts in FSIS' regulations is to ensure that condemned and other inedible materials are rendered incapable of use as human food. After these materials have been subjected to an inedible rendering process, incinerated, or denatured, further disposition is conducted in accordance with applicable Federal, state, and local laws and regulations. FSIS works with other governmental entities to ensure that the disposition of SRMs and other inedible materials complies with environmental requirements.

Comment: Some comments requested that FSIS develop compliance guidelines on the removal, segregation, and disposition of SRMs specifically for the U.S. meat packing industry.

Response: FSIS has posted compliance guidance materials for its BSE-related rules on the FSIS Technical Services Center Web page at: http:// www.fsis.usda.gov/About--FSIS/Technical--Service--Center/index.asp.

In addition, after it issued the SRM interim final rule, FSIS held a series of teaching workshops from January through March 2004 to discuss the actions that the Agency had taken to prevent human exposure to the BSE agent. These workshops were designed to assist small and very small plants to understand the requirements of the measures implemented by FSIS to prevent human exposure to the BSE agent. Materials provided at these workshops are available on the FSIS Web site at: http://www.fsis.usda.gov/Science/Workshop--SmallPlants-- BSE/index.asp.

Shipment of Carcasses and Parts That Contain Vertebral Columns

9 CFR 310.22(e) of the SRM interim final rule (which has been re-designated as 9 CFR 310.22(h) in this final rule) provides that materials designated as SRMs 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 at the time of slaughter. In the preamble to the SRM interim final rule, FSIS explained that for 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 which the carcasses or parts were derived (60 FR 1861, 1869-1870, January 12, 2004). The preamble also states that if an establishment that processes the carcasses or parts of cattle does not have records that document the age of the cattle from which the carcasses were derived, it must handle all carcasses and parts as if they were from cattle 30 months of age and older.

FSIS permits federally-inspected establishments that slaughter cattle to ship carcasses and parts that contain vertebral columns from cattle that were 30 months of age and older at the time of slaughter to another federally-inspected establishment for processing if both establishments have controls in place to ensure that the SRM portions of the vertebral column are removed and properly disposed of. When beef carcasses or parts that contain SRM vertebral columns are transported from one official establishment to another, both the transporting establishment and the receiving establishment must develop and maintain documentation and on-going verification to ensure that the SRMs are removed, segregated from edible materials, and disposed of as inedible. If establishments have implemented appropriate controls, FSIS inspection personnel at the shipping establishment will apply the mark of inspection to carcasses or parts that contain SRM vertebral bones as an accommodation to facilitate their transport to a processing facility where the SRMs can be removed and properly disposed of.

To assist with implementation of the SRM interim final rule, FSIS issued an FSIS notice that instructs its inspection program personnel on how to verify the effectiveness of controls adopted by establishments that transport or receive cattle carcasses or parts that contain vertebral columns from cattle 30 months of age and older (see FSIS Notice 68-05, "Verification Activities at Establishments that Transport or Receive Cattle Carcasses or Parts with Vertebral Columns that Contain Specified Risk Materials (SRMs)," October 6, 2005). FSIS Notice 68-05 instructs inspection program personnel at establishments that transport for *38712 further processing carcasses or parts of carcasses that contain vertebral columns from cattle that were 30 months of age and older at the time of slaughter to verify that the establishment: (1) Maintains control of the carcasses or parts while they are in transit (through companies seals or under FSIS control); (2) ensures that the carcasses or parts are accompanied by documentation that clearly identifies that the carcasses or parts are from cattle that were 30 months of age and older at the time of slaughter or that clearly states that the vertebral column must be removed and disposed of as an SRM; (3) maintains records that identify the official establishment that received the carcasses or parts; (4) incorporates its procedures into its HACCP System. FSIS Notice 68-05 also provides that inspectors at establishments that process cattle carcasses and parts are to verify that the establishment (1) has implemented controls to identify carcasses or parts that contain vertebral columns with SRM portions; (2) has implemented controls to ensure that the SRM portions of the vertebral column are properly handled and disposed of; (3) has incorporated its controls into its HACCP System; and (4) maintains records that verify that the SRM portions of the vertebral column were removed and disposed of as inedible.

In January 2006, the USDA Office of the Inspector General (OIG) issued an audit report that found that establishments transporting carcasses and parts from cattle 30 months and older often did not have