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From: TSS ()
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.


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FSIS NOTICE 56-07

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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

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(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

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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/FSISNotices/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. [flounder9@verizon.net]

Sent: Thursday, September 08, 2005 6:17 PM

To: fsis.regulationscomments@fsis.usda.gov

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_interest/public-press_office/public-press_releases_2000/public-mrc-43-00.htm


SNIP...FULL TEXT;

9/13/2005

Page 3 of 17

https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument

[Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine
Spongiform Encephalopathy (BSE)

http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.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




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