| FSIS NOTICE |
4-04 |
1/9/04 |
This Notice Has Expired. It is Provided Here for Informational Purposes Only.
Awareness Meeting Regarding New Regulations That Prohibit
Non-Ambulatory Disabled Cattle and the Use of Certain Materials From Cattle for
Human Food
FSIS will issue three regulations and a notice in the Federal Register on
January 12, 2004, in response to the diagnosis by USDA of a positive case of BSE
in an adult Holstein cow in the State of Washington. These regulations and the
notice will minimize human exposure to materials that scientific studies have
demonstrated as containing the BSE agent in cattle infected with the disease.
The regulations prohibit the slaughter of non-ambulatory disabled cattle and
identify a list of materials, including Specified Risk Materials (SRMs), that
may present a risk for transmitting Bovine Spongiform Encephalopathy (BSE) and
are now inedible:
For all cattle:
The tonsils are an SRM
The small intestine -- the distal ileum is the SRM
For cattle 30 months of age and older:
The head – skull, eyes, brain, and trigeminal ganglia are the SRMs
The vertebral column – spinal cord and dorsal root ganglia (DRG) are the SRMs
Upon receipt of this FSIS notice, at establishments that slaughter cattle or
establishments that process bone-in parts of cattle carcasses, inspection
program personnel are to inform plant management through an awareness meeting
about the new regulations and policies, inform them that the regulations are
available on the FSIS website at
http://www.fsis.usda.gov/oa/news/2004/bseregs.htm, provide them a copy of
applicable checklists (see attachments), and inform them
that as of Monday January 12, 2004, regulatory requirements will be in
effect that prohibit the slaughter of non-ambulatory disabled cattle and that
require establishments to ensure the removal, segregation, and disposition of
SRMs. Inspection program personnel are to inform plant management that if an
establishment slaughters non-ambulatory disabled cattle or fails to ensure the
removal, segregation, and disposition of SRMs, inspection program personnel will
take a regulatory control action as set out in 9 CFR 500.2(a)(3), conditions
preclude FSIS from determining that product is not adulterated.
At the first weekly scheduled PBIS meeting after receipt of this FSIS notice,
inspection program personnel are to review the applicable checklist with the
plant management to ensure that the establishment understands what is required
under the new regulations. Because the new regulations and policies are for the
most part food safety related for beef products, inspection program personnel
also are to inform the establishment that it is to reassess its hazard analysis
to determine what steps, if any, are necessary to ensure that its products are
free of materials that present the risk of transmitting BSE infectivity. Also at
this meeting, inspection program personnel are to inform plant management that
by the time of the second weekly PBIS-scheduled meeting, inspection program
personnel will begin to verify that the establishment has incorporated the
appropriate procedures and controls into Hazard Analysis and Critical Control
Point (HACCP) plans, Sanitation Standard Operating Procedures (Sanitation SOPs),
or prerequisite programs as required by the new regulations. Inspection program
personnel also are to inform plant management that if it does not address
procedures and controls in its HACCP plans, Sanitation SOPs, or prerequisite
programs, a Notice of Intended Enforcement Action will be issued.
In a memorandum of interview, inspection program personnel are to
document who was present at the initial awareness meeting, the date and time of
the meeting, what was discussed, and any documents that were shared with
management. Inspection program personnel are to maintain a copy of the
memorandum in the official government file and provide a copy to the plant
management.
In the interim period prior to the second weekly scheduled PBIS meeting, while
the establishment is reassessing the HACCP plan(s), if inspection program
personnel identify noncompliance it will be documented as 06D01 using the
“product based” trend indicator.
At the second weekly scheduled PBIS meeting, inspection program personnel are to
verify that the establishment has addressed, in writing, the necessary
procedures and controls within the HACCP plan, Sanitation SOPs, or prerequisite
program.
After the second weekly scheduled PBIS meeting, inspection program personnel
will verify that the requirements are being met utilizing the HACCP or the
Sanitation SOPs procedure and document noncompliance accordingly.
/s/ Philip S. Derfler
Assistant Administrator
Office Policy and Program Development
| DISTRIBUTION: Inspection Offices; T/A Inspectors; Plant Mgt; T/A Plant Mgt; TRA; ABB; TSC; Import Offices | NOTICE EXPIRES: 2/01/05 | OPI: OPPD
|
that non-ambulatory disabled livestock, including cattle, are now defined in 9 CFR 309.2(b) 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?
that the new regulations state that non-ambulatory disabled cattle are to be condemned and disposed of in accordance with 9 CFR 309.13?
that cattle, regardless of whether they are non-ambulatory disabled, can no longer be slaughtered under the emergency slaughter provisions of the regulations, in modified 9 CFR 311.27?
that captive bolt stunners that deliberately inject compressed air (air injection stunning) into the cranium at the end of the penetration cycle shall not be used to stun cattle (see 9 CFR 3313.15(b)(2)(ii))?
that the heads from cattle 30 months of age or older are to be condemned unless the establishment can ensure that the stunning does not result in brain leakage onto the head?
that cattle selected by APHIS for BSE Surveillance testing that are not non-ambulatory disabled are slaughtered but will be held and are not “inspected and passed” until the results of the test are received and are negative?
What is being done to ensure that these cattle do not enter the establishment?
What is being done to ensure that these cattle are humanely handled and killed in a timely fashion, and removed from the premises to prevent insanitary conditions?

that the regulations at 9 CFR 310.22(a) designate the following materials as SRMs and prohibit their use for human food:
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 the distal ileum (distal ileum is a SRM, but to ensure effective removal of the distal ileum, the establishment is required to remove the entire small intestine from all cattle)?
that if it does not segregate cattle 30 months of age and older from younger cattle it is to handle all cattle as if they were 30 months of age and older?
that it is recommended if old and young cattle are slaughtered and intended to be segregated, that the young cattle are slaughtered before old cattle or that the equipment used on the cattle 30 months of age and older is sanitized and there is no cross-contamination of carcasses less than 30 months of age.
How it will ensure appropriate segregation and disposal of the small intestine and tonsils of all cattle?
How it will determine age of cattle, such as by records or dentition?
How it will segregate cattle 30
months of age and older from cattle
younger than 30 months.
How it is removing, segregating, and disposing of SRMs to ensure that there is no cross-contamination with edible product? (NOTE: For example, the vertebral columns from cattle 30 months of age and older do not have to be removed during the slaughter operation. However, if they are not removed in the slaughter operation, procedures must be put in place to ensure that the vertebral columns are adequately identified as being from cattle 30 months of age and older and the documentation transfers with the vertebral columns until they are appropriately disposed of as inedible.)

that the new regulations (9 CFR 310.22) prohibit the use of the skulls and vertebral columns from cattle 30 months of age and older (except for the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum)? (NOTE: Parts of carcasses 30 months of age and older can enter the boning operation, post-slaughter and post-chill, for the removal of the SRMs).
that if it does not have documentation about the age of the cattle from which vertebral columns are derived, it is to handle all skulls and vertebral columns as if they were from cattle 30 months of age and older?
that the traditional T-bone or porterhouse steaks and bone-in rib roasts can no longer come from cattle 30 months of age and older (i.e., a portion of the vertebral column bone defining these cuts of meat must now be removed, resulting in a semi-boneless cut of meat)?
How it receives documentation from the slaughter operation regarding the age of cattle from which the skulls and vertebral columns are derived?
How it will segregate the skull and prohibited sections of the vertebral column from cattle 30 months of age and older (i.e., the bones that contain central nervous system-type tissues) from all other bones?

that the new regulations (9 CFR 318.24) prohibit the use of the skulls or vertebral columns (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum bones) of cattle 30 months of age or older from use in an AMR system?
that the new regulations (9 CFR 318.24) prohibit product derived from AMR systems from the bones of cattle of any age from containing any central nervous system-type tissues (i.e., brain and trigeminal ganglia from the skull, or spinal cord and DRG from the vertebral column)?
that the new regulations (9 CFR 319.5) prohibit the use of Mechanically Separated (Beef) and that these labels will be rescinded?
that there are additional new
non-food safety related regulatory requirements
(9 CFR 318.24) related to the production of AMR for bone solids (calcium) and
bone marrow (iron)?
how it segregates skulls and vertebral columns from cattle 30 months of age and older from skulls and vertebral columns from cattle younger than 30 months?
how it will prevent product derived
from AMR systems from containing brain, trigeminal ganglia, spinal cord, or
DRG?