1. Food Safety and Inspection Service Overview of New Regulations and Policies to Further Enhance Safeguards Against Bovine Spongiform Encephalopathy (BSE) Mary Porretta Regulations and Petitions Policy Staff Office of Policy and Program Development Food Safety and Inspection Service United States Department of Agriculture

2. Food Safety and Inspection Service (FSIS) Mission is to ensure that meat, poultry, and processed egg products are wholesome, not adulterated, and properly marked, labeled, and packaged Provisions in FSIS regulations issued in response to the detection of the BSE case in the US on December 23, 2003, are intended to prevent human exposure to the BSE agent through consumption of meat and meat food products

3. Overview of FSIS Policies Related to BSE January 12, 2004, FSIS published 3 interim final rules and a notice in the Federal Register All regulations were issued as emergency interim final rules, effective immediately upon publication

4. Overview of FSIS Policies Related to BSE Interim final rules have a 90-day comment period that closes on April 12, 2004 After the comment period closes FSIS will analyze all comments received and later will publish another document in the Federal Register that will include a discussion of the comments received and any amendments made as a result of those comments

5. Overview FSIS Policies Related to BSE “ Prohibition of the Use of Specified Risk Materials for Human Food and Requirements for the Disposition of Non-Ambulatory Disabled Cattle” (69 FR 1862) “Meat Produced by Advanced Meat/Bone Separation Machinery and Meat Recovery Systems” (69 FR 1862)

6. Overview of the New FSIS Regulations “Prohibition of the Use of Certain Stunning Devices Used to Immobilize Cattle During Slaughter” (69 FR 1885) “Bovine Spongiform Encephalopathy Surveillance Program” (69 FR 1892)

7. Prohibition of the Use of Specified Risk Materials for Human Food Designates certain materials from cattle as “specified risk materials” (SRMs) Declares that SRMs are inedible and prohibits their use for human food

8. Prohibition of the Use of Specified Risk Materials for Human Food Materials designated as SRMs include: 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

9. Prohibition of the Use of Specified Risk Materials for Human Food To ensure complete removal of the distal ileum, establishments must remove and dispose of as inedible the entire small intestine Establishments that slaughter cattle, or that process the carcasses or parts of cattle, are required to develop, implement, and maintain written procedures for the removal, segregation, and disposition of SRMs Procedures must be addressed in HACCP plan, Sanitation SOP, or other prerequisite program

10. Prohibition of the Use of Specified Risk Materials for Human Food Establishments must maintain daily records that document the implementation and monitoring of their procedures FSIS verifies the adequacy and effectiveness of the procedures

11. Prohibition of the Use of Specified Risk Materials for Human Food Materials are deemed to be from cattle 30 months of age and older unless the establishment can demonstrate that materials are from an animal that was less than 30 months of age at the time of slaughter Documentation or dentition may be used to determine the age of cattle offered for slaughter SRM regulations to be codified at 9 CFR 310.22

12. Requirements for the Disposition of Non-Ambulatory Disabled Cattle “Non-ambulatory disabled livestock” 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 (9 CFR 309.2)

13. Requirements for the Disposition of Non-Ambulatory Disabled Cattle Carcasses of non-ambulatory disabled cattle prohibited for human food Non-ambulatory disabled cattle that are presented for slaughter must be condemned (9 CFR 309.3) Condemned livestock cannot be taken into the establishment to be slaughtered or dressed (9 CFR 309.13)

14. Advanced Meat Recovery (AMR) Systems and Mechanically Separated(MS) (beef) 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 product When produced properly, product derived from AMR systems is comparable to meat derived by hand deboning and can be labeled as “meat”

15. AMR and MS (Beef) Under former (and current) FSIS regulations spinal cord not considered a component of boneless meat Under former regulations, beef AMR product found to contain spinal cord was permitted to be used for human food if re-labeled as MS(beef) (provided that other requirements for MS(beef) were met)

16. AMR and MS (Beef) New regulations declare MS (beef) inedible and prohibit its use for human food (9 CFR319.5(b))

17. Meat Produced by AMR Systems Vertebral columns and skulls of cattle 30 months of age and older cannot be used in the production of AMR product (9 CFR 310.22 and 9 CFR 318.24(a)) AMR product identified as meat cannot contain any brain, trigeminal ganglia, spinal cord, or DRG (9 CFR 301.2 and 9 CFR 318.24(a) and (c)) Meat produced using AMR systems cannot contain unacceptable levels of bone solids or bone marrow (9 CFR 318.24(a) and (c))

18. Meat Produced by AMR Systems Establishments must develop, implement, and maintain procedures that ensure that AMR process is in control (9 CFR 318.24(b)) Procedures must include observation of the bones that enter the system and testing of the product that exists the system

19. Meat Produced by AMR Systems FSIS conducts regulatory verification testing for the presence of spinal cord and DRG in AMR product

20. Prohibition of the Use of Air- Injection Stunning for Cattle Captive bolt stunning devices that deliberately inject air into the cranial cavity cannot be used to stun cattle prior to slaughter

21. BSE Surveillance Testing FSIS will not pass and apply the mark of inspection to the carcasses and parts from cattle that are selected for testing for BSE by APHIS until the sample is determined to be negative (“test and hold”)

22. FSIS Policies and Guidance Materials A series of FSIS Notices have been issued to provide additional clarification to FSIS inspection program personnel on the new policies All policies published in the Federal Register available on FSIS web site at: http://www.fsis.usda.gov/oa/news/2004/bseregs.htm Related FSIS Notices available on FSIS web site at: http://www.fsis.usda.gov/oa/topics/bse.htm