Food Safety and Inspection Food Safety and Inspection Service Service Overview of New Regulations and Overview of New Regulations and Policies to Further Enhance Policies to Further Enhance Safeguards Against Bovine Safeguards Against Bovine Spongiform Encephalopathy (BSE) 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
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Food Safety and Inspection ServiceFood Safety and Inspection Service
Overview of New Regulations and Policies Overview of New Regulations and Policies to Further Enhance Safeguards Against to Further Enhance Safeguards Against
Food Safety and Inspection ServiceFood Safety and Inspection Service (FSIS)(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
Overview of FSIS Policies Overview of FSIS Policies Related to BSERelated 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
Overview of FSIS Policies Overview of FSIS Policies Related to BSE 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
Overview FSIS Policies Overview FSIS Policies Related to BSERelated 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)
Overview of the New FSIS Overview of the New FSIS RegulationsRegulations
“Prohibition of the Use of Certain Stunning Devices Used to Immobilize Cattle During Slaughter” (69 FR 1885)
Prohibition of the Use of Specified Prohibition of the Use of Specified Risk Materials for Human Food 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
Prohibition of the Use of Specified Prohibition of the Use of Specified Risk Materials for Human FoodRisk 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
Prohibition of the Use of Specified Prohibition of the Use of Specified Risk Materials for Human FoodRisk 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
Prohibition of the Use of Specified Prohibition of the Use of Specified Risk Materials for Human FoodRisk 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
Prohibition of the Use of Specified Prohibition of the Use of Specified Risk Materials for Human FoodRisk 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
Requirements for the Disposition of Requirements for the Disposition of Non-Ambulatory Disabled CattleNon-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)
Requirements for the Disposition of Requirements for the Disposition of Non-Ambulatory Disabled CattleNon-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)
Advanced Meat Recovery (AMR) Advanced Meat Recovery (AMR) Systems and Mechanically Systems and Mechanically
Separated(MS) (beef)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”
AMR and MS (Beef)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)
AMR and MS (Beef)AMR and MS (Beef)
New regulations declare MS (beef) inedible and prohibit its use for human food
(9 CFR319.5(b))
Meat Produced by AMR SystemsMeat 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))
Meat Produced by AMR Meat Produced by AMR SystemsSystems
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
Meat Produced by AMR SystemsMeat Produced by AMR Systems
FSIS conducts regulatory verification testing for the presence of spinal cord and DRG in AMR product
Prohibition of the Use of Air-Prohibition of the Use of Air-Injection Stunning for CattleInjection Stunning for Cattle
Captive bolt stunning devices that deliberately inject air into the cranial cavity cannot be used to stun cattle prior to slaughter
BSE Surveillance TestingBSE 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”)
FSIS Policies and Guidance FSIS Policies and Guidance MaterialsMaterials
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
