Subject: FINAL REGULATIONS FOR NON-AMBULATORY DISABLED CATTLE AND SPECIFIED
RISK MATERIALS (SRMs)
Date: August 31, 2007 at 9:21 am PST
UNITED STATES DEPARTMENT OF AGRICULTURE
FOOD SAFETY AND INSPECTION SERVICE
WASHINGTON, DC
FSIS NOTICE
56-07
8/31/07
DISTRIBUTION: Electronic
NOTICE EXPIRES: 10/1/08 OPI: OPPED
FINAL REGULATIONS FOR NON-AMBULATORY DISABLED CATTLE AND SPECIFIED RISK
MATERIALS (SRMs)
I. PURPOSE This notice announces the publication of the SRM final rule,
"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" (also referred to as "the SRM final rule"). It also
announces that FSIS will issue two new directives. The new directives will
consolidate information from all the current FSIS notices related to
non-ambulatory disabled cattle and SRMs. Finally, this notice also instructs
inspection program personnel to meet with the establishment management to
discuss the provisions of the final SRM rule and the changes since the
interim final rule. NOTE: It is important, in enforcing the SRM regulations
that should it be necessary for inspection program personnel to write a
noncompliance record (NR), they cite 9 CFR 310.22. FSIS Notice 05-07
emphasized the need to do this, yet an on-going review of NRs shows that
inspection program personnel have not consistently followed this direction.
Therefore, this notice reminds inspection program personnel of the need to
cite this regulation and advises them that adherence to this direction will
be closely monitored. II. BACKGROUND On July 13, 2007, FSIS published the
SRM final rule (see link below).
http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/03-025F.pdf This final rule
(referred to as "the SRM final rule") makes permanent, with certain changes,
interim regulations that FSIS issued in January 2004 to prevent potential
human exposure to the bovine spongiform encephalopathy (BSE) agent. Like the
interim regulations, the SRM final rule prescribes requirements for the
handling and disposition of SRMs, requires that all non-ambulatory disabled
cattle that are offered for slaughter be condemned, prohibits the use of
mechanically separated (beef) (MS(beef))
for human food, and prohibits the use of air-injection stunning devices on
cattle. The SRM final rule will become effective on October 1, 2007. III.
INSPECTION PROGRAM PERSONNEL RESPONSIBILITIES A. Awareness Meeting 1. Upon
receipt of this notice, inspection program personnel at establishments that
slaughter cattle, and at establishments that process carcasses or parts of
cattle carcasses, are to conduct an awareness meeting with establishment
management. At the meeting, inspection program personnel are to: a. inform
the establishment that FSIS issued a final rule effective October 1, 2007,
that affirmed the air-injection stunning regulations without changes and
affirmed, with some changes, the regulations related to non-ambulatory
disabled cattle and SRMs; b. provide the establishment with link to the
rule; c. discuss the regulations. (See the attached regulatory talking
points); and d. advise the establishment that, because there are changes in
the regulations that may affect the establishment's hazard analysis or alter
its hazard analysis critical control point (HACCP) plan, it is required
under 9 CFR 417.4(a)(3) to reassess the adequacy of the HACCP plan. The
establishment needs to do so by October 1, 2007, the effective date of the
regulation. 2. In a memorandum of interview, inspection program personnel
are to document: a. who was present at this initial awareness meeting; b.
the date and time of the meeting; c. what was discussed, and d. any
documents that were shared with management. 3. Inspection program personnel
are to maintain a copy of the memorandum in the official government file and
provide a copy to the establishment management. B. Verification
Responsibilities Beginning October 1, 2007, inspection program personnel
will use FSIS Directives 6100.1, Ante-Mortem Inspection of Livestock and
FSIS Directive 6100.4, Verification Instructions Related to Specified Risk
Materials (SRMs), which FSIS will issue shortly, to verify the existing and
new regulatory requirements related to non-ambulatory disabled cattle and
SRMs. Refer questions to the Policy Development Division (formerly the TSC)
at 1-800-233-3935.
2
FSIS NOTICE 56-07
3
Assistant Administrator Office of Policy, Program, and Employee Development
TALKING POINTS FOR THE SRM REGULATIONS The SRM final rule affirms the
interim regulations on the handling and disposition of non-ambulatory
disabled cattle. FSIS modified some of the interim regulations to codify
existing practices. Following is a summary of the permanent regulatory
requirements. NON-AMBULATORY DISABLED CATTLE • 9 CFR 309.2(b) permanently
replaces the term "downer" with non-ambulatory disabled livestock. 9 CFR
309.2(b) continues to define "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. • 9 CFR 309.3(e) continues to require that non-ambulatory
disabled cattle that are offered for slaughter be condemned. However, this
requirement now also clarifies that FSIS inspection personnel will determine
the disposition of cattle that become non-ambulatory disabled after such
cattle have passed ante-mortem inspection on a case-by-case basis. This
revision reflects current Agency practices but adds this clarification to
the regulatory text. • 9 CFR 309.13(b) continues to list conditions for
which condemned livestock may be set aside and treated. However, this
requirement now also clarifies that veal calves that cannot rise from a
recumbent position, or that cannot walk because they are tired or cold, may
be set apart and held for treatment. This revision also reflects current
Agency practices but adds this clarification to the regulatory text. • 9 CFR
311.27 continues to prohibit for use as human food of the parts and
carcasses of cattle slaughtered for humane reasons in the absence of an
inspector SRMs 9 CFR 310.22 of the SRM final rule affirms, with certain
changes, the interim requirements for the handling and disposition of SRMs.
Following is a description of these regulations and the changes made in the
SRM final rule. • 9 CFR 310.22 (a) continues to define "SRMs" as: (1) the
brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column
(excluding the vertebrae of the tail, the transverse processes of the
thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root
ganglia (DRG) of cattle 30 months of age and older, and
4
(2) the tonsils and the distal ileum from all cattle. • 9 CFR 310.22(a) also
contains a new provision that excludes from the definition of SRM materials
from cattle from a country that can demonstrate that its BSE risk status can
reasonably be expected to provide the same level of protection from human
exposure to the BSE agent as excluding SRMs from the human food supply does
in the United States. As of the date of this notice, no foreign countries
have qualified to have materials from their cattle excluded from the
definition of "SRMs." Countries that that believe that they are eligible for
this exemption have been instructed to notify FSIS' Office of International
Affairs (OIA) and to provide that Office with sufficient scientific evidence
to support their claimed BSE risk status. When, and if, countries begin to
qualify to have materials from their cattle excluded from FSIS' definition
of "SRMs", FSIS will notify its Import Inspection Personnel and provide the
appropriate instructions for implementing this part of the regulations • 9
CFR 310.22(b) continues to provide that SRMs are inedible and must not be
used for human food. • 9 CFR 310.22(c) continues to provide that SRMs must
be disposed of in accordance with 9 CFR 314.1 and 314.3. It also contains a
new provision that provides that the spinal cord from cattle 30 months of
age and older must be removed from the carcass at the establishment where
the animal was slaughtered. • 9 CFR 310.22(d) contains requirements for the
use of the small intestine for human food. These requirements were in 9 CFR
310.22(a)(3) of the interim final rule but are otherwise unchanged. • 9 CFR
310.22(e) requires that establishments that slaughter cattle, and
establishments that process the carcasses or parts of cattle: o develop,
implement, and maintain written procedures for the removal, segregation, and
disposition of SRMs; o incorporate these procedures into their HACCP plan or
into their Sanitation SOP or other prerequisite program. These requirements
were in 9 CFR 310.22(e) of the interim final rule but are otherwise
unchanged. o contains a new provision, 9 CFR 310.22(e)(1), which clarifies
that an establishment's procedures for the removal, segregation, and
disposition of SRMs must address potential contamination of edible materials
before, during and after entry into the establishment. • 9 CFR 310.22 (f)
sets out sanitation requirements for equipment used to cut through SRMs.
This is a new provision that makes into a requirement the sanitation
procedures that FSIS had described in FSIS Notice 10-04, "Questions and
Answers Regarding the Age Determination of Cattle and Sanitation." • 9 CFR
310.22 (g) sets out the requirements for slaughter establishments shipping
beef carcasses and parts from cattle 30 months of age and older
FSIS NOTICE 56-07
5
containing vertebral columns. This is a new provision that adopts as a
requirement the procedures for transporting vertebral columns that FSIS had
described in 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). Under this section,
establishments that transport carcasses or parts that contain vertebral
columns from cattle 30 months of age and older are required to maintain
records that document that the official establishment that received the
carcasses or parts removed the SRM portions of the vertebral column. • 9 CFR
310.22(h) provides that materials that are designated as SRMs if they are
from cattle 30 months of age and older will be deemed to be SRMs unless the
establishment can demonstrate through documentation that the materials are
from an animal that was younger than 30 months of age at the time of
slaughter. AIR-INJECTION STUNNING AND MS (beef) • 9 CFR 313.15(b)(2) and 9
CFR 310.13(a)(2)(iv)(C) continue to prohibit the use of stunning devices
that deliberately inject compressed air into the cranial cavity of cattle. •
9 CFR 319.5(b) continues to prohibit MS(beef) for human food.
http://www.fsis.usda.gov/OPPDE/rdad/FSI ... /56-07.pdf
[Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk
Materials for Human Food and Requirement for the Disposition of
Non-Ambulatory Disabled Cattle
03-025IFA
03-025IFA-2
Terry S. Singeltary
Page 1 of 17
From: Terry S. Singeltary Sr. [[email protected]]
Sent: Thursday, September 08, 2005 6:17 PM
To: [email protected]
Subject: [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified
Risk Materials for Human Food and Requirements
for the Disposition of Non-Ambulatory Disabled Cattle
Greetings FSIS,
I would kindly like to submit the following to [Docket No. 03-025IFA] FSIS
Prohibition of the Use of Specified Risk Materials for Human Food and
Requirements for the Disposition of Non-Ambulatory Disabled Cattle
THE BSE/TSE SUB CLINICAL Non-Ambulatory Disabled Cattle
Broken bones and such may be the first signs of a sub clinical BSE/TSE
Non-Ambulatory Disabled Cattle ;
SUB CLINICAL PRION INFECTION
MRC-43-00
Issued: Monday, 28 August 2000
NEW EVIDENCE OF SUB-CLINICAL PRION INFECTION: IMPORTANT RESEARCH
FINDINGS RELEVANT TO CJD AND BSE
A team of researchers led by Professor John Collinge at the Medical
Research Council Prion Unit1 report today in the Proceedings of the
National Academy of Sciences, on new evidence for the existence of a
?sub-clinical? form of BSE in mice which was unknown until now.
The scientists took a closer look at what is known as the ?species
barrier? - the main protective factor which limits the ability of
prions2 to jump from one species to infect another. They found the mice
had a ?sub-clinical? form of disease where they carried high levels of
infectivity but did not develop the clinical disease during their normal
lifespan. The idea that individuals can carry a disease and show no
clinical symptoms is not new. It is commonly seen in conventional
infectious diseases.
Researchers tried to infect laboratory mice with hamster prions3 called
Sc237 and found that the mice showed no apparent signs of disease.
However, on closer inspection they found that the mice had high levels
of mouse prions in their brains. This was surprising because it has
always been assumed that hamster prions could not cause the disease in
mice, even when injected directly into the brain.
In addition the researchers showed that this new sub-clinical infection
could be easily passed on when injected into healthy mice and hamsters.
The height of the species barrier varies widely between different
combinations of animals and also varies with the type or strain of
prions. While some barriers are quite small (for instance BSE easily
infects mice), other combinations of strain and species show a seemingly
impenetrable barrier. Traditionally, the particular barrier studied here
was assumed to be robust.
Professor John Collinge said: "These results have a number of important
implications. They suggest that we should re-think how we measure
species barriers in the laboratory, and that we should not assume that
just because one species appears resistant to a strain of prions they
have been exposed to, that they do not silently carry the infection.
9/13/2005
2
Page 2 of 17
This research raises the possibility, which has been mentioned before,
that apparently healthy cattle could harbour, but never show signs of, BSE.
"This is a timely and unexpected result, increasing what we know about
prion disease. These new findings have important implications for those
researching prion disease, those responsible for preventing infected
material getting into the food chain and for those considering how best
to safeguard health and reduce the risk that theoretically, prion
disease could be contracted through medical and surgical procedures."
ISSUED FRIDAY 25 AUGUST UNDER EMBARGO. PLEASE NOTE THAT THE EMBARGO IS
SET BY THE JOURNAL.
FOR FURTHER INFORMATION CONTACT THE MRC PRESS OFFICE ON 020 7637 6011
(OFFICE HOURS) OR 07818 428297 OR 0385 774357 (OUT-OF-OFFICE-HOURS) OR
PROFESSOR JOHN COLLINGE ON 020 7594 3760. PLEASE NOTE THAT OWING TO
TRAVEL COMMITMENTS PROFESSOR COLLINGE WILL ONLY BE AVAILABLE UNTIL 16.30
ON FRIDAY 25 AUGUST AND CONTACTABLE AGAIN ON MONDAY 28 AUGUST VIA THE
MRC PRESS OFFICE. DR ANDREW HILL (A CO-AUTHOR ON THE PAPER) FROM THE
DEPARTMENT OF PATHOLOGY AT THE UNIVERSITY OF MELBOURNE WILL BE AVAILABLE
ON 00 61 3 8344 3995 (DURING OFFICE HOURS) OR 00 61 3 9443 0009
(OUT-OF-OFFICE HOURS). PLEASE NOTE THAT AUSTRALIA IS TEN HOURS AHEAD OF
UK TIME.
NOTES FOR EDITORS
Professor Collinge is a consultant neurologist and Director of the newly
formed MRC Prion Unit based at The Imperial College School of Medicine
at St Mary?s Hospital. He is also a member of the UK Government?s
Spongiform Encephalopathy Advisory Committee (SEAC). The MRC prion unit
is was set up in 1999, and its work includes molecular genetic studies
of human prion disease and transgenic modelling of human prion diseases.
Prions are unique infectious agents that cause fatal brain diseases such
as Creutzfeldt-Jakob disease (CJD) in humans and scrapie and BSE (mad
cow disease) in animals. In some circumstances prions from one species
of animals can infect another and it is clear that BSE has done this to
cause the disease variant CJD in the UK and France. It remains unclear
how large an epidemic of variant CJD will occur over the years ahead.
The strain of prion used here to infect the mice is the Sc237 strain
(also known as 263K) which infects hamsters, and until now was assumed
not to infect mice.
This research was funded by the Medical Research Council and Wellcome
Trust.
The Medical Research Council (MRC) is a national organisation funded by
the UK tax-payer. Its business is medical research aimed at improving
human health; everyone stands to benefit from the outputs. The research
it supports and the scientists it trains meet the needs of the health
services, the pharmaceutical and other health-related industries and the
academic world. MRC has funded work which has led to some of the most
significant discoveries and achievements in medicine in the UK. About
half of the MRC?s expenditure of £345 million is invested in over 50 of
its Institutes and Units, where it employs its own research staff. The
remaining half goes in the form of grant support and training awards to
individuals and teams in universities and medical schools.
The Wellcome Trust is the world's largest medical research charity with
a spend of some £600 million in the current financial year 1999/2000.
The Wellcome Trust supports more than 5,000 researchers, at 400
locations, in 42 different countries to promote and foster research with
the aim of improving human and animal health. As well as funding major
initiatives in the public understanding of science, the Wellcome Trust
is the country's leading supporter of research into the history of
medicine.
http://www.mrc.ac.uk/index/public_inter ... -43-00.htm
SNIP...FULL TEXT;
9/13/2005
Page 3 of 17
https://web01.aphis.usda.gov/regpublic. ... enDocument
[Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine
Spongiform Encephalopathy (BSE)
http://www.fsis.usda.gov/OPPDE/Comments ... 0011-1.pdf
suppressed peer review of Harvard study October 31, 2002
http://www.fsis.usda.gov/oa/topics/BSE_Peer_Review.pdf
Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518
RISK MATERIALS (SRMs)
Date: August 31, 2007 at 9:21 am PST
UNITED STATES DEPARTMENT OF AGRICULTURE
FOOD SAFETY AND INSPECTION SERVICE
WASHINGTON, DC
FSIS NOTICE
56-07
8/31/07
DISTRIBUTION: Electronic
NOTICE EXPIRES: 10/1/08 OPI: OPPED
FINAL REGULATIONS FOR NON-AMBULATORY DISABLED CATTLE AND SPECIFIED RISK
MATERIALS (SRMs)
I. PURPOSE This notice announces the publication of the SRM final rule,
"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" (also referred to as "the SRM final rule"). It also
announces that FSIS will issue two new directives. The new directives will
consolidate information from all the current FSIS notices related to
non-ambulatory disabled cattle and SRMs. Finally, this notice also instructs
inspection program personnel to meet with the establishment management to
discuss the provisions of the final SRM rule and the changes since the
interim final rule. NOTE: It is important, in enforcing the SRM regulations
that should it be necessary for inspection program personnel to write a
noncompliance record (NR), they cite 9 CFR 310.22. FSIS Notice 05-07
emphasized the need to do this, yet an on-going review of NRs shows that
inspection program personnel have not consistently followed this direction.
Therefore, this notice reminds inspection program personnel of the need to
cite this regulation and advises them that adherence to this direction will
be closely monitored. II. BACKGROUND On July 13, 2007, FSIS published the
SRM final rule (see link below).
http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/03-025F.pdf This final rule
(referred to as "the SRM final rule") makes permanent, with certain changes,
interim regulations that FSIS issued in January 2004 to prevent potential
human exposure to the bovine spongiform encephalopathy (BSE) agent. Like the
interim regulations, the SRM final rule prescribes requirements for the
handling and disposition of SRMs, requires that all non-ambulatory disabled
cattle that are offered for slaughter be condemned, prohibits the use of
mechanically separated (beef) (MS(beef))
for human food, and prohibits the use of air-injection stunning devices on
cattle. The SRM final rule will become effective on October 1, 2007. III.
INSPECTION PROGRAM PERSONNEL RESPONSIBILITIES A. Awareness Meeting 1. Upon
receipt of this notice, inspection program personnel at establishments that
slaughter cattle, and at establishments that process carcasses or parts of
cattle carcasses, are to conduct an awareness meeting with establishment
management. At the meeting, inspection program personnel are to: a. inform
the establishment that FSIS issued a final rule effective October 1, 2007,
that affirmed the air-injection stunning regulations without changes and
affirmed, with some changes, the regulations related to non-ambulatory
disabled cattle and SRMs; b. provide the establishment with link to the
rule; c. discuss the regulations. (See the attached regulatory talking
points); and d. advise the establishment that, because there are changes in
the regulations that may affect the establishment's hazard analysis or alter
its hazard analysis critical control point (HACCP) plan, it is required
under 9 CFR 417.4(a)(3) to reassess the adequacy of the HACCP plan. The
establishment needs to do so by October 1, 2007, the effective date of the
regulation. 2. In a memorandum of interview, inspection program personnel
are to document: a. who was present at this initial awareness meeting; b.
the date and time of the meeting; c. what was discussed, and d. any
documents that were shared with management. 3. Inspection program personnel
are to maintain a copy of the memorandum in the official government file and
provide a copy to the establishment management. B. Verification
Responsibilities Beginning October 1, 2007, inspection program personnel
will use FSIS Directives 6100.1, Ante-Mortem Inspection of Livestock and
FSIS Directive 6100.4, Verification Instructions Related to Specified Risk
Materials (SRMs), which FSIS will issue shortly, to verify the existing and
new regulatory requirements related to non-ambulatory disabled cattle and
SRMs. Refer questions to the Policy Development Division (formerly the TSC)
at 1-800-233-3935.
2
FSIS NOTICE 56-07
3
Assistant Administrator Office of Policy, Program, and Employee Development
TALKING POINTS FOR THE SRM REGULATIONS The SRM final rule affirms the
interim regulations on the handling and disposition of non-ambulatory
disabled cattle. FSIS modified some of the interim regulations to codify
existing practices. Following is a summary of the permanent regulatory
requirements. NON-AMBULATORY DISABLED CATTLE • 9 CFR 309.2(b) permanently
replaces the term "downer" with non-ambulatory disabled livestock. 9 CFR
309.2(b) continues to define "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. • 9 CFR 309.3(e) continues to require that non-ambulatory
disabled cattle that are offered for slaughter be condemned. However, this
requirement now also clarifies that FSIS inspection personnel will determine
the disposition of cattle that become non-ambulatory disabled after such
cattle have passed ante-mortem inspection on a case-by-case basis. This
revision reflects current Agency practices but adds this clarification to
the regulatory text. • 9 CFR 309.13(b) continues to list conditions for
which condemned livestock may be set aside and treated. However, this
requirement now also clarifies that veal calves that cannot rise from a
recumbent position, or that cannot walk because they are tired or cold, may
be set apart and held for treatment. This revision also reflects current
Agency practices but adds this clarification to the regulatory text. • 9 CFR
311.27 continues to prohibit for use as human food of the parts and
carcasses of cattle slaughtered for humane reasons in the absence of an
inspector SRMs 9 CFR 310.22 of the SRM final rule affirms, with certain
changes, the interim requirements for the handling and disposition of SRMs.
Following is a description of these regulations and the changes made in the
SRM final rule. • 9 CFR 310.22 (a) continues to define "SRMs" as: (1) the
brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column
(excluding the vertebrae of the tail, the transverse processes of the
thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root
ganglia (DRG) of cattle 30 months of age and older, and
4
(2) the tonsils and the distal ileum from all cattle. • 9 CFR 310.22(a) also
contains a new provision that excludes from the definition of SRM materials
from cattle from a country that can demonstrate that its BSE risk status can
reasonably be expected to provide the same level of protection from human
exposure to the BSE agent as excluding SRMs from the human food supply does
in the United States. As of the date of this notice, no foreign countries
have qualified to have materials from their cattle excluded from the
definition of "SRMs." Countries that that believe that they are eligible for
this exemption have been instructed to notify FSIS' Office of International
Affairs (OIA) and to provide that Office with sufficient scientific evidence
to support their claimed BSE risk status. When, and if, countries begin to
qualify to have materials from their cattle excluded from FSIS' definition
of "SRMs", FSIS will notify its Import Inspection Personnel and provide the
appropriate instructions for implementing this part of the regulations • 9
CFR 310.22(b) continues to provide that SRMs are inedible and must not be
used for human food. • 9 CFR 310.22(c) continues to provide that SRMs must
be disposed of in accordance with 9 CFR 314.1 and 314.3. It also contains a
new provision that provides that the spinal cord from cattle 30 months of
age and older must be removed from the carcass at the establishment where
the animal was slaughtered. • 9 CFR 310.22(d) contains requirements for the
use of the small intestine for human food. These requirements were in 9 CFR
310.22(a)(3) of the interim final rule but are otherwise unchanged. • 9 CFR
310.22(e) requires that establishments that slaughter cattle, and
establishments that process the carcasses or parts of cattle: o develop,
implement, and maintain written procedures for the removal, segregation, and
disposition of SRMs; o incorporate these procedures into their HACCP plan or
into their Sanitation SOP or other prerequisite program. These requirements
were in 9 CFR 310.22(e) of the interim final rule but are otherwise
unchanged. o contains a new provision, 9 CFR 310.22(e)(1), which clarifies
that an establishment's procedures for the removal, segregation, and
disposition of SRMs must address potential contamination of edible materials
before, during and after entry into the establishment. • 9 CFR 310.22 (f)
sets out sanitation requirements for equipment used to cut through SRMs.
This is a new provision that makes into a requirement the sanitation
procedures that FSIS had described in FSIS Notice 10-04, "Questions and
Answers Regarding the Age Determination of Cattle and Sanitation." • 9 CFR
310.22 (g) sets out the requirements for slaughter establishments shipping
beef carcasses and parts from cattle 30 months of age and older
FSIS NOTICE 56-07
5
containing vertebral columns. This is a new provision that adopts as a
requirement the procedures for transporting vertebral columns that FSIS had
described in 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). Under this section,
establishments that transport carcasses or parts that contain vertebral
columns from cattle 30 months of age and older are required to maintain
records that document that the official establishment that received the
carcasses or parts removed the SRM portions of the vertebral column. • 9 CFR
310.22(h) provides that materials that are designated as SRMs if they are
from cattle 30 months of age and older will be deemed to be SRMs unless the
establishment can demonstrate through documentation that the materials are
from an animal that was younger than 30 months of age at the time of
slaughter. AIR-INJECTION STUNNING AND MS (beef) • 9 CFR 313.15(b)(2) and 9
CFR 310.13(a)(2)(iv)(C) continue to prohibit the use of stunning devices
that deliberately inject compressed air into the cranial cavity of cattle. •
9 CFR 319.5(b) continues to prohibit MS(beef) for human food.
http://www.fsis.usda.gov/OPPDE/rdad/FSI ... /56-07.pdf
[Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk
Materials for Human Food and Requirement for the Disposition of
Non-Ambulatory Disabled Cattle
03-025IFA
03-025IFA-2
Terry S. Singeltary
Page 1 of 17
From: Terry S. Singeltary Sr. [[email protected]]
Sent: Thursday, September 08, 2005 6:17 PM
To: [email protected]
Subject: [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified
Risk Materials for Human Food and Requirements
for the Disposition of Non-Ambulatory Disabled Cattle
Greetings FSIS,
I would kindly like to submit the following to [Docket No. 03-025IFA] FSIS
Prohibition of the Use of Specified Risk Materials for Human Food and
Requirements for the Disposition of Non-Ambulatory Disabled Cattle
THE BSE/TSE SUB CLINICAL Non-Ambulatory Disabled Cattle
Broken bones and such may be the first signs of a sub clinical BSE/TSE
Non-Ambulatory Disabled Cattle ;
SUB CLINICAL PRION INFECTION
MRC-43-00
Issued: Monday, 28 August 2000
NEW EVIDENCE OF SUB-CLINICAL PRION INFECTION: IMPORTANT RESEARCH
FINDINGS RELEVANT TO CJD AND BSE
A team of researchers led by Professor John Collinge at the Medical
Research Council Prion Unit1 report today in the Proceedings of the
National Academy of Sciences, on new evidence for the existence of a
?sub-clinical? form of BSE in mice which was unknown until now.
The scientists took a closer look at what is known as the ?species
barrier? - the main protective factor which limits the ability of
prions2 to jump from one species to infect another. They found the mice
had a ?sub-clinical? form of disease where they carried high levels of
infectivity but did not develop the clinical disease during their normal
lifespan. The idea that individuals can carry a disease and show no
clinical symptoms is not new. It is commonly seen in conventional
infectious diseases.
Researchers tried to infect laboratory mice with hamster prions3 called
Sc237 and found that the mice showed no apparent signs of disease.
However, on closer inspection they found that the mice had high levels
of mouse prions in their brains. This was surprising because it has
always been assumed that hamster prions could not cause the disease in
mice, even when injected directly into the brain.
In addition the researchers showed that this new sub-clinical infection
could be easily passed on when injected into healthy mice and hamsters.
The height of the species barrier varies widely between different
combinations of animals and also varies with the type or strain of
prions. While some barriers are quite small (for instance BSE easily
infects mice), other combinations of strain and species show a seemingly
impenetrable barrier. Traditionally, the particular barrier studied here
was assumed to be robust.
Professor John Collinge said: "These results have a number of important
implications. They suggest that we should re-think how we measure
species barriers in the laboratory, and that we should not assume that
just because one species appears resistant to a strain of prions they
have been exposed to, that they do not silently carry the infection.
9/13/2005
2
Page 2 of 17
This research raises the possibility, which has been mentioned before,
that apparently healthy cattle could harbour, but never show signs of, BSE.
"This is a timely and unexpected result, increasing what we know about
prion disease. These new findings have important implications for those
researching prion disease, those responsible for preventing infected
material getting into the food chain and for those considering how best
to safeguard health and reduce the risk that theoretically, prion
disease could be contracted through medical and surgical procedures."
ISSUED FRIDAY 25 AUGUST UNDER EMBARGO. PLEASE NOTE THAT THE EMBARGO IS
SET BY THE JOURNAL.
FOR FURTHER INFORMATION CONTACT THE MRC PRESS OFFICE ON 020 7637 6011
(OFFICE HOURS) OR 07818 428297 OR 0385 774357 (OUT-OF-OFFICE-HOURS) OR
PROFESSOR JOHN COLLINGE ON 020 7594 3760. PLEASE NOTE THAT OWING TO
TRAVEL COMMITMENTS PROFESSOR COLLINGE WILL ONLY BE AVAILABLE UNTIL 16.30
ON FRIDAY 25 AUGUST AND CONTACTABLE AGAIN ON MONDAY 28 AUGUST VIA THE
MRC PRESS OFFICE. DR ANDREW HILL (A CO-AUTHOR ON THE PAPER) FROM THE
DEPARTMENT OF PATHOLOGY AT THE UNIVERSITY OF MELBOURNE WILL BE AVAILABLE
ON 00 61 3 8344 3995 (DURING OFFICE HOURS) OR 00 61 3 9443 0009
(OUT-OF-OFFICE HOURS). PLEASE NOTE THAT AUSTRALIA IS TEN HOURS AHEAD OF
UK TIME.
NOTES FOR EDITORS
Professor Collinge is a consultant neurologist and Director of the newly
formed MRC Prion Unit based at The Imperial College School of Medicine
at St Mary?s Hospital. He is also a member of the UK Government?s
Spongiform Encephalopathy Advisory Committee (SEAC). The MRC prion unit
is was set up in 1999, and its work includes molecular genetic studies
of human prion disease and transgenic modelling of human prion diseases.
Prions are unique infectious agents that cause fatal brain diseases such
as Creutzfeldt-Jakob disease (CJD) in humans and scrapie and BSE (mad
cow disease) in animals. In some circumstances prions from one species
of animals can infect another and it is clear that BSE has done this to
cause the disease variant CJD in the UK and France. It remains unclear
how large an epidemic of variant CJD will occur over the years ahead.
The strain of prion used here to infect the mice is the Sc237 strain
(also known as 263K) which infects hamsters, and until now was assumed
not to infect mice.
This research was funded by the Medical Research Council and Wellcome
Trust.
The Medical Research Council (MRC) is a national organisation funded by
the UK tax-payer. Its business is medical research aimed at improving
human health; everyone stands to benefit from the outputs. The research
it supports and the scientists it trains meet the needs of the health
services, the pharmaceutical and other health-related industries and the
academic world. MRC has funded work which has led to some of the most
significant discoveries and achievements in medicine in the UK. About
half of the MRC?s expenditure of £345 million is invested in over 50 of
its Institutes and Units, where it employs its own research staff. The
remaining half goes in the form of grant support and training awards to
individuals and teams in universities and medical schools.
The Wellcome Trust is the world's largest medical research charity with
a spend of some £600 million in the current financial year 1999/2000.
The Wellcome Trust supports more than 5,000 researchers, at 400
locations, in 42 different countries to promote and foster research with
the aim of improving human and animal health. As well as funding major
initiatives in the public understanding of science, the Wellcome Trust
is the country's leading supporter of research into the history of
medicine.
http://www.mrc.ac.uk/index/public_inter ... -43-00.htm
SNIP...FULL TEXT;
9/13/2005
Page 3 of 17
https://web01.aphis.usda.gov/regpublic. ... enDocument
[Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine
Spongiform Encephalopathy (BSE)
http://www.fsis.usda.gov/OPPDE/Comments ... 0011-1.pdf
suppressed peer review of Harvard study October 31, 2002
http://www.fsis.usda.gov/oa/topics/BSE_Peer_Review.pdf
Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518
