18 September 2006 - Production or use of farmed animal feed containing restricted animal proteins leaflet
http://www.defra.gov.uk/animalh/bse/con ... eaflet.pdf
STRICTLY PRIVATE AND CONFIDENTIAL 25, AUGUST 1995
snip...
To minimise the risk of farmers' claims for compensation from feed
compounders.
To minimise the potential damage to compound feed markets through adverse publicity.
To maximise freedom of action for feed compounders, notably by
maintaining the availability of meat and bone meal as a raw
material in animal feeds, and ensuring time is available to make any
changes which may be required.
snip...
THE FUTURE
4..........
MAFF remains under pressure in Brussels and is not skilled at
handling potentially explosive issues.
5. Tests _may_ show that ruminant feeds have been sold which
contain illegal traces of ruminant protein. More likely, a few positive
test results will turn up but proof that a particular feed mill knowingly
supplied it to a particular farm will be difficult if not impossible.
6. The threat remains real and it will be some years before feed
compounders are free of it. The longer we can avoid any direct
linkage between feed milling _practices_ and actual BSE cases,
the more likely it is that serious damage can be avoided. ...
SEE full text ;
http://www.bseinquiry.gov.uk/files/yb/1 ... 002001.pdf
USA 2006
http://www.usda.gov/oig/webdocs/50601-10-KC.pdf
Possible contamination of dairy feeds with ruminant derived meat and bone meal.
FEED RECALL USA SEPT 6, 2006 1961.72 TONS IN COMMERCE AL, TN, AND WV
Date: September 6, 2006 at 7:58 am PST
http://www.fda.gov/bbs/topics/enforce/2 ... 00968.html
Possible contamination of animal feed ingredients, including ingredients
that are used in feed for dairy animals, with ruminant derived meat and bone
meal. RECALLS ENFORCEMENT REPORT FOR AUGUST 9, 2006 KY, LA,
MS, AL, GA, AND TN 11,000+ TONS
http://www.fda.gov/bbs/topics/ENFORCE/2 ... 00964.html
The feed was manufactured from materials that may have been contaminated
with mammalian protein. RECALL MI MAMMALIAN PROTEIN VOLUME OF PRODUCT IN COMMERCE 27,694,240 lbs
http://www.fda.gov/bbs/topics/enforce/2 ... 00963.html
Animal and fish feeds which were possibly contaminated with ruminant based
protein not labeled as "Do not feed to ruminants". RECALL AL AND FL VOLUME OF PRODUCT IN COMMERCE 125 TONS Products manufactured from 02/01/2005 until 06/06/2006
http://www.fda.gov/bbs/topics/enforce/2 ... 00963.html
USDA 2003
We have to be careful that we don't get so set in the way we do things that
we forget to look for different emerging variations of disease. We've gotten
away from collecting the whole brain in our systems. We're using the brain
stem and we're looking in only one area. In Norway, they were doing a
project and looking at cases of Scrapie, and they found this where they did
not find lesions or PRP in the area of the obex. They found it in the
cerebellum and the cerebrum. It's a good lesson for us. Ames had to go
back and change the procedure for looking at Scrapie samples. In the USDA,
we had routinely looked at all the sections of the brain, and then we got
away from it. They've recently gone back.
Dr. Keller: Tissues are routinely tested, based on which tissue provides an
'official' test result as recognized by APHIS.
Dr. Detwiler: That's on the slaughter. But on the clinical cases, aren't
they still asking for the brain? But even on the slaughter, they're looking
only at the brainstem. We may be missing certain things if we confine
ourselves to one area.
snip.............
Dr. Detwiler: It seems a good idea, but I'm not aware of it.
Another important thing to get across to the public is that the negatives
do not guarantee absence of infectivity. The animal could be early in the
disease and the incubation period. Even sample collection is so important.
If you're not collecting the right area of the brain in sheep, or if
collecting lymphoreticular tissue, and you don't get a good biopsy, you
could miss the area with the PRP in it and come up with a negative test.
There's a new, unusual form of Scrapie that's been detected in Norway. We
have to be careful that we don't get so set in the way we do things that we
forget to look for different emerging variations of disease. We've gotten
away from collecting the whole brain in our systems. We're using the brain
stem and we're looking in only one area. In Norway, they were doing a
project and looking at cases of Scrapie, and they found this where they did
not find lesions or PRP in the area of the obex. They found it in the
cerebellum and the cerebrum. It's a good lesson for us. Ames had to go
back and change the procedure for looking at Scrapie samples. In the USDA,
we had routinely looked at all the sections of the brain, and then we got
away from it. They've recently gone back.
Dr. Keller: Tissues are routinely tested, based on which tissue provides an
'official' test result as recognized by APHIS
.
Dr. Detwiler: That's on the slaughter. But on the clinical cases, aren't
they still asking for the brain? But even on the slaughter, they're looking
only at the brainstem. We may be missing certain things if we confine
ourselves to one area.
snip...
FULL TEXT;
Completely Edited Version
PRION ROUNDTABLE
Accomplished this day, Wednesday, December 11, 2003, Denver, Colorado
2005
=============================
AFTER this administration put Dr. Detwiler out to pasture cause she did not
agree with there BSE protocols, she was so wrong, she now works to make sure
our beef at McDonald's is safe cause McDonalds saw the writing on the wall ;
International Scientific Advisory Council
McDonald's International Scientific Advisory Council adds further strength
to our beef safety program by providing independent expert scientific and
medical advice on bovine spongiform encephalopathy (BSE).
COUNCIL MEMBERS
Dr. Neil Cashman. Diener Professor of Neurodegenerative Diseases and
Director, Neuromuscular Disease Clinic, Sunnybrook & Women's Health Sciences
Center, University of Toronto. Specialist in motor neuron diseases and the
cell biology of amyloid encephalopathies, including prion illnesses. Author
of over 250 publications. Recipient of the 2000 Jonas Salk Prize for
biomedical research.
Dr. Dean Danilson. Vice President QAFS, Tyson Foods, Inc. Responsible for
quality assurance and food safety programs for the retail division for fresh
beef, pork, poultry and ready-to-eat meats.
Dr. Linda Detwiler. Adjunct Professor, Virginia-Maryland Regional College of
Veterinary Medicine, University of Maryland. Also provides private animal
health consulting services, with specializations in transmissible spongiform
encephalopathies, emergency preparedness, and animal product issues related
to imports and exports. Formerly Senior Staff Veterinarian, Emergency
Programs Staff, U.S. Department of Agriculture Animal and Plant Health
Inspection Service, the unit principally responsible for surveillance,
prevention, and education activities related to BSE. Member of various
international working groups and advisory committees on TSEs. Author of
numerous articles on the issues.
Alan A. Harris, M.D. Professor of Internal Medicine and Preventive Medicine,
Senior Assistant Chairman, Department of Internal Medicine, Hospital
Epidemiologist, Rush-Presbyterian-St. Luke's Medical Center. Specialist in
public health and foodborne illnesses. Fellow, Infectious Diseases Society
of America. Fellow, American College of Physicians. Member, Society of
Healthcare Epidemiology of America. Author or co-author of more than 140
scientific publications.
Dr. Beat Hörnlimann, MPH. Managing Director, SVISS Consulting, BSE 7192
Ltd., an organization that provides expert advice on public and animal
health, particularly with respect to BSE. Formerly Chief Veterinary Officer,
Public Health Department, Kanton Zug, Switzerland. Led Swiss BSE and scrapie
eradication program and served in numerous other senior-level staff and
advisory positions related to TSEs. Author of a book on prions and prion
diseases in humans and animals.
Dr. David Kessler. Dean, School of Medicine, Yale University and former
Commissioner, U.S. Food and Drug Administration. Author of A Question of
Intent (on federal tobacco regulation efforts) and numerous articles in
major medical journals. Member, Board of Directors, Elizabeth Glaser
Pediatric AIDS Foundation, Doctors of the World, National Center for
Addiction and Substance, Henry Kaiser Family Foundation. Recipient of
numerous medical public service awards, including the American Heart
Association National Public Affairs Special Recognition Award, American
Academy of Pediatrics Excellence in Public Service Award, and American
Cancer Society Medal of Honor.
Dr. Colin Masters. Professor and Head, Department of Pathology, University
of Melbourne. Specialist in neuropathology. Member, numerous national and
international medical professional societies.
Dr. Carols Messuti. Ministry of Livestock, Agriculture, and Fishing,
Government of Uruguay and Delegate to the OIE, the UN's principal agency for
animal diseases.
Dr. Jeffrey W. Savell. Professor, E.M. ?Manny? Rosenthal Chairholder, and
Leader, Meat Science Section, Department of Animal Science, Texas A&M
University. Specialist in meat quality/consistency, food safety and
nutrition. Past President, American Meat Science Association; member,
Institute of Food Technologists, American Society of Animal Science, HACCP
Alliance. Author or co-author of more than 250 articles and co-author of the
Laboratory Manual for Meat Science. Recipient of numerous awards for
research and teaching.
Dr. James Toole. Walter C. Teagle Professor of Neurology, Professor of
Public Health Sciences, and Director, Stroke Research Center, Wake Forest
University School of Medicine. President, International Stroke Society;
member and past-president, World Federation of Neurology; member and
past-president American Neurological Association; fellow, Royal College of
Physicians; master, American College of Physicians. Author of
Cerebrovascular Disorders and over 600 medical textbook chapters; co-editor
Handbook of Clinical Neurology. Former editor, Journal of the Neurological
Sciences.
http://www.mcdonalds.com/corp/values/so ... tific.html
September 13,2004
USDA, FSTS
Docket Clerk
300 12* Street, SW
Room 102, Cotton Annex
Washington, DC 20250
04-021ANPR
04-021ANPR-70
Richard L. Crawford
Re: Docket No: 04-02 1 ANPR Federal Measures to Mitigate BSE Risks:
Considerations
for Further Action
Dear Sir or Madame:
On behalf of McDonald's Corporation, which operates more than 13,000
restaurants in
the United States, we appreciate the opportunity to submit comments to this
very
important Advance Notice of Proposed Rulemaking (ANPRM). 69 Fed. Reg. 42288
(July
14,2004).
In previous comments submitted to FSIS regarding the removal of SRI&,
McDonalds
fully supported this rule and its immediate implementation. The removal of
SRMs from
human food is the primary firewall to protect the US consumer from being
exposed to the
BSE agent. While we applaud the requirement for SRM removal, we feel that it
is
equally important for FSIS to insure that each slaughterplant which
processes cattle have
systems in place which prevent cross contamination between edible tissue and
SRMs.
This should include but not be limited to the use of separate equipment,
such as knives,
blades, etc. where appropriate. In addition, it is also important that
appropriate and
effective disinfection procedures for equipment used to handle SRMs be
developed and
approved for use.
It is our opinion that requiring SRM removal without a procedure to prevent
cross
contamination is inadequate as a protective public health measure. The TSE
agents
@ions) are sticky and highly resistant to disinfection. If SRMs such as
brain and spinal
cord are allowed to contact equipment and other surfaces such as deboning
tables which
then are used to handle and process edible tissue this could allow
contamination and
negates the intention of the ban. This is true not only in plants
slaughtering fed cattle
both under and over 30 months but also in plants slaughtering predominately
older cattle.
It is important that measure be taken to prevent cross contamination between
carcasses
and SRms in the cull plants. McDonalds requires their suppliers to prevent
cross
contamination and audits against certain measurable standards such as
requiring spinal
cord to bc removed on the kill floor. We would be willing to share these
standards with
FSIS as an example.
FSIS Docket No. 04-02 1 ANPR
dooqhl- =w c1qo -
McDonalds again recommends that dura (the covering around the brain and
spinal cord)
be added to the list of SRMs. While skull and vertebral column are included
as SRMs,
dura is not. If dura is not removed prior to processing on the fabrication
floor, it may
come loose and be incorporated into ground product. Bovine dura was never
tested for
infectivity. It was assumed that due to direct contact with spinal cord, it
may serve as a
vehicle to transmit disease. In addition, human dura has been the source of
human to
human transmission of Creutzfeldt-Jakob Disease (CJD). (personal
communication - Dr.
Danny Matthews, UK, VLA) Our ISAC committee recommended that McDonalds add
the removal of dura as a specification in the production of our product.
McDonalds urges the USDA to make the appropriate adjustments in the SRM ban
if new
scientific findings and/or the results of the increased surveillance warrant
a change.
In regards to imported meat products from other countries, McDonalds
suggests that no
SRM exemption be made for countries based on BSE risk. The long incubation
period
and limited surveillance in many countries can limit the ability to
accurately determine
risk. Also, the risk level of a country could potentially change over night
if the trading
patterns of a country changed. It seems logistically impossible to maintain
a system
which could continually monitor the world's trading patterns. In addition,
science has
not provided all of the answers in regards to the transmission of BSE.
Requiring SRMs
to be removed from imported products for human food is prudent. If the US
would wait
until disease is confirmed the exposure would already have occurred.
Thank you for the opportunity to comment on these very important issues.
Richard L. Crawford
Corporat,e Vice President, Government Relations
McDonalds Corporation
1 Kroc Drive
Oak Brook, Illinois 60523
FSIS Docket No. 04-021ANPR
http://www.fda.gov/ohrms/dockets/dailys ... -vol22.pdf
THE USDA JUNE 2004 ENHANCED BSE SURVEILLANCE PROGRAM WAS TERRIBLY FLAWED ;
CDC DR. PAUL BROWN TSE EXPERT COMMENTS 2006
The U.S. Department of Agriculture was quick to assure the public earlier
this week that the third case of mad cow disease did not pose a risk to
them, but what federal officials have not acknowledged is that this latest
case indicates the deadly disease has been circulating in U.S. herds for at
least a decade.
The second case, which was detected last year in a Texas cow and which USDA
officials were reluctant to verify, was approximately 12 years old.
These two cases (the latest was detected in an Alabama cow) present a
picture of the disease having been here for 10 years or so, since it is
thought that cows usually contract the disease from contaminated feed they
consume as calves. The concern is that humans can contract a fatal,
incurable, brain-wasting illness from consuming beef products contaminated
with the mad cow pathogen.
"The fact the Texas cow showed up fairly clearly implied the existence of
other undetected cases," Dr. Paul Brown, former medical director of the
National Institutes of Health's Laboratory for Central Nervous System
Studies and an expert on mad cow-like diseases, told United Press
International. "The question was, 'How many?' and we still can't answer
that."
Brown, who is preparing a scientific paper based on the latest two mad cow
cases to estimate the maximum number of infected cows that occurred in the
United States, said he has "absolutely no confidence in USDA tests before
one year ago" because of the agency's reluctance to retest the Texas cow
that initially tested positive.
USDA officials finally retested the cow and confirmed it was infected seven
months later, but only at the insistence of the agency's inspector general.
"Everything they did on the Texas cow makes everything USDA did before 2005
suspect," Brown said. ...snip...end
http://www.upi.com/ConsumerHealthDaily/ ... 5557-1284r
CDC - Bovine Spongiform Encephalopathy and Variant Creutzfeldt ...
Dr. Paul Brown is Senior Research Scientist in the Laboratory of Central
Nervous System ... Address for correspondence: Paul Brown, Building 36, Room
4A-05, ...
http://www.cdc.gov/ncidod/eid/vol7no1/brown.htm
CDC - Afterthoughts about Bovine Spongiform Encephalopathy and ...
Afterthoughts about Bovine Spongiform Encephalopathy and Variant
Creutzfeldt-Jakob Disease. Paul Brown Senior Investigator, National
Institutes of Health, ...
http://www.cdc.gov/ncidod/eid/vol7no3_supp/brown.htm
December 20,2005
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane
Room 1061
Rockville, MD 20852
Re: Docket No: 2002N-0273 (formerly Docket No. 02N-0273)
Substances Prohibited From Use in Animal Food and Feed
Dear Sir or Madame:
As scientists and Irecognized experts who have worked in the field of TSEs
for
decades, we are deeply concerned by the recent discoveries of indigenous BSE
infected
cattle in North America and appreciate the opportunity to submit comments to
this very
important proposed rule We strongly supported the measures that USDA and FDA
implemented to protect public health after the discovery of the case of
bovine spongiform
encephalopathy (BSE) found in Washington State in 2003. We know of no event
or
discovery since then that could justify relaxing the existing specified risk
material
(SRM) and non-ambulatory bans and surveillance that were implemented at that
time.
Further, we strongly supported the codification of those changes, as well as
additional
measures to strengthen the entire feed and food system. The discovery of
additional
cases of indigenous BSE in North America since that time has validated our
position and
strengthened OUT convictions.
We caution against using the 18 month enhanced surveillance as a
justification to relax or
impede further actions. While this surveillance has not uncovered an
epidemic, it does
not clear the US cattle herd from infection. While it is highly likely that
US and
Canadian cattle were exposed to BSE prior to the 1997 feed ban, we do not
know how
many cattle were infected or how widely the infection was dispersed. BSE
cases are
most likely clustered in time and location, so while enhanced surveillance
provides an 18
month snapshot, it does uot negate the fact that US and Canadian cattle were
exposed to
BSE. We also do not know in any quantitative or controlled way how effective
the feed
ban has been, especially at the farm level. At this point we cannot even
make a thorough
assessment of the USDA surveillance as details such as age, risk category
and regional
distribution have not been released.
see full text 18 pages ;
http://www.fda.gov/ohrms/dockets/docket ... -vol40.pdf
[GAO-05-101 ] Mad Cow Disease: FDA's Management of the Feed Ban Has
Improved, but Oversight Weaknesses Continue to Limit Program Effectiveness
Size: 104986 , Score: 1000 , TEXT , PDF , SUMMARY
http://frwebgate.access.gpo.gov/cgi-bin ... s/data/gao
[2]
[GAO-05-101 ] Mad Cow Disease: FDA's Management of the Feed Ban Has
Improved, but Oversight Weaknesses Continue to Limit Program Effectiveness
Size: 104986 , Score: 1000 , TEXT , PDF , SUMMARY
http://frwebgate.access.gpo.gov/cgi-bin ... s/data/gao
[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
http://www.fsis.usda.gov/OPPDE/Comments ... 5IFA-2.pdf
Subject: Substances Prohibited from Use in Animal Food or Feed, Proposed
Rule, Docket No. 2002N-0273 C-534 VOL 45 (PhRMA) and Entered On February 17,
2006
Date: March 10, 2006 at 5:23 pm PST
Marie A. Vodicka, PhD
Assistant Vice President
Biologics & Blotechnology
Scientlflc & Regulatory Affairs
SCIENCE & REG AFFAIRS
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rrn . 1061
Rackville, MD 20862
Re: Substances Prohibited from Use in Animal Food or Feed, Proposed Rule,
Docket
No. 2002N-0273
February 14, 2006
Dear Sir or Madam :
The Pharmaceutical Research and Manufacturers of America (PhRMA) is
providing
comment to the proposed rules issued. ......
snip...
http://www.fda.gov/ohrms/dockets/docket ... -vol45.pdf
Subject: Docket No: 2002N-0273 (formerly Docket No. 02N-0273) Substances
Prohibited From Use in Animal Food and Feed PAUL BROWN
Date: January 20, 2006 at 9:31 am PST
December 20,2005
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane
Room 1061
Rockville, MD 20852
Re: Docket No: 2002N-0273 (formerly Docket No. 02N-0273)
Substances Prohibited From Use in Animal Food and Feed
Dear Sir or Madame:
As scientists and Irecognized experts who have worked in the field of TSEs
for
decades, we are deeply concerned by the recent discoveries of indigenous BSE
infected
cattle in North America and appreciate the opportunity to submit comments to
this very.........
snip...
Given that BSE can be transmitted to cattle via an
oral route with just .OO1 gram of infected tissue, it may not take much
infectivity to
contaminate feed and keep the disease recycling. ........
http://www.fda.gov/ohrms/dockets/docket ... -vol40.pdf
THE SEVEN SCIENTIST REPORT ***
http://www.fda.gov/ohrms/dockets/docket ... tach-1.pdf
Subject: [Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine
Spongiform Encephalopathy (BSE)
http://www.fsis.usda.gov/OPPDE/Comments ... 0011-1.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
9/13/2005
http://www.fsis.usda.gov/OPPDE/Comments ... 5IFA-2.pdf
Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW BSE SAFEGUARDS (comment submission)
https://web01.aphis.usda.gov/regpublic. ... enDocument
Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL
IMPORTS FROM CANADA
https://web01.aphis.usda.gov/BSEcom.nsf ... AutoFramed
Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION]
http://www.fda.gov/ohrms/dockets/docket ... 000001.txt
Docket Management Docket: 02N-0273 - Substances Prohibited From Use in
Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
Comment Number: EC -10
Accepted - Volume 2
http://www.fda.gov/ohrms/dockets/dailys ... 4be07.html
PART 2
http://www.fda.gov/ohrms/dockets/dailys ... 4be09.html
TSS
http://www.defra.gov.uk/animalh/bse/con ... eaflet.pdf
STRICTLY PRIVATE AND CONFIDENTIAL 25, AUGUST 1995
snip...
To minimise the risk of farmers' claims for compensation from feed
compounders.
To minimise the potential damage to compound feed markets through adverse publicity.
To maximise freedom of action for feed compounders, notably by
maintaining the availability of meat and bone meal as a raw
material in animal feeds, and ensuring time is available to make any
changes which may be required.
snip...
THE FUTURE
4..........
MAFF remains under pressure in Brussels and is not skilled at
handling potentially explosive issues.
5. Tests _may_ show that ruminant feeds have been sold which
contain illegal traces of ruminant protein. More likely, a few positive
test results will turn up but proof that a particular feed mill knowingly
supplied it to a particular farm will be difficult if not impossible.
6. The threat remains real and it will be some years before feed
compounders are free of it. The longer we can avoid any direct
linkage between feed milling _practices_ and actual BSE cases,
the more likely it is that serious damage can be avoided. ...
SEE full text ;
http://www.bseinquiry.gov.uk/files/yb/1 ... 002001.pdf
USA 2006
http://www.usda.gov/oig/webdocs/50601-10-KC.pdf
Possible contamination of dairy feeds with ruminant derived meat and bone meal.
FEED RECALL USA SEPT 6, 2006 1961.72 TONS IN COMMERCE AL, TN, AND WV
Date: September 6, 2006 at 7:58 am PST
http://www.fda.gov/bbs/topics/enforce/2 ... 00968.html
Possible contamination of animal feed ingredients, including ingredients
that are used in feed for dairy animals, with ruminant derived meat and bone
meal. RECALLS ENFORCEMENT REPORT FOR AUGUST 9, 2006 KY, LA,
MS, AL, GA, AND TN 11,000+ TONS
http://www.fda.gov/bbs/topics/ENFORCE/2 ... 00964.html
The feed was manufactured from materials that may have been contaminated
with mammalian protein. RECALL MI MAMMALIAN PROTEIN VOLUME OF PRODUCT IN COMMERCE 27,694,240 lbs
http://www.fda.gov/bbs/topics/enforce/2 ... 00963.html
Animal and fish feeds which were possibly contaminated with ruminant based
protein not labeled as "Do not feed to ruminants". RECALL AL AND FL VOLUME OF PRODUCT IN COMMERCE 125 TONS Products manufactured from 02/01/2005 until 06/06/2006
http://www.fda.gov/bbs/topics/enforce/2 ... 00963.html
USDA 2003
We have to be careful that we don't get so set in the way we do things that
we forget to look for different emerging variations of disease. We've gotten
away from collecting the whole brain in our systems. We're using the brain
stem and we're looking in only one area. In Norway, they were doing a
project and looking at cases of Scrapie, and they found this where they did
not find lesions or PRP in the area of the obex. They found it in the
cerebellum and the cerebrum. It's a good lesson for us. Ames had to go
back and change the procedure for looking at Scrapie samples. In the USDA,
we had routinely looked at all the sections of the brain, and then we got
away from it. They've recently gone back.
Dr. Keller: Tissues are routinely tested, based on which tissue provides an
'official' test result as recognized by APHIS.
Dr. Detwiler: That's on the slaughter. But on the clinical cases, aren't
they still asking for the brain? But even on the slaughter, they're looking
only at the brainstem. We may be missing certain things if we confine
ourselves to one area.
snip.............
Dr. Detwiler: It seems a good idea, but I'm not aware of it.
Another important thing to get across to the public is that the negatives
do not guarantee absence of infectivity. The animal could be early in the
disease and the incubation period. Even sample collection is so important.
If you're not collecting the right area of the brain in sheep, or if
collecting lymphoreticular tissue, and you don't get a good biopsy, you
could miss the area with the PRP in it and come up with a negative test.
There's a new, unusual form of Scrapie that's been detected in Norway. We
have to be careful that we don't get so set in the way we do things that we
forget to look for different emerging variations of disease. We've gotten
away from collecting the whole brain in our systems. We're using the brain
stem and we're looking in only one area. In Norway, they were doing a
project and looking at cases of Scrapie, and they found this where they did
not find lesions or PRP in the area of the obex. They found it in the
cerebellum and the cerebrum. It's a good lesson for us. Ames had to go
back and change the procedure for looking at Scrapie samples. In the USDA,
we had routinely looked at all the sections of the brain, and then we got
away from it. They've recently gone back.
Dr. Keller: Tissues are routinely tested, based on which tissue provides an
'official' test result as recognized by APHIS
.
Dr. Detwiler: That's on the slaughter. But on the clinical cases, aren't
they still asking for the brain? But even on the slaughter, they're looking
only at the brainstem. We may be missing certain things if we confine
ourselves to one area.
snip...
FULL TEXT;
Completely Edited Version
PRION ROUNDTABLE
Accomplished this day, Wednesday, December 11, 2003, Denver, Colorado
2005
=============================
AFTER this administration put Dr. Detwiler out to pasture cause she did not
agree with there BSE protocols, she was so wrong, she now works to make sure
our beef at McDonald's is safe cause McDonalds saw the writing on the wall ;
International Scientific Advisory Council
McDonald's International Scientific Advisory Council adds further strength
to our beef safety program by providing independent expert scientific and
medical advice on bovine spongiform encephalopathy (BSE).
COUNCIL MEMBERS
Dr. Neil Cashman. Diener Professor of Neurodegenerative Diseases and
Director, Neuromuscular Disease Clinic, Sunnybrook & Women's Health Sciences
Center, University of Toronto. Specialist in motor neuron diseases and the
cell biology of amyloid encephalopathies, including prion illnesses. Author
of over 250 publications. Recipient of the 2000 Jonas Salk Prize for
biomedical research.
Dr. Dean Danilson. Vice President QAFS, Tyson Foods, Inc. Responsible for
quality assurance and food safety programs for the retail division for fresh
beef, pork, poultry and ready-to-eat meats.
Dr. Linda Detwiler. Adjunct Professor, Virginia-Maryland Regional College of
Veterinary Medicine, University of Maryland. Also provides private animal
health consulting services, with specializations in transmissible spongiform
encephalopathies, emergency preparedness, and animal product issues related
to imports and exports. Formerly Senior Staff Veterinarian, Emergency
Programs Staff, U.S. Department of Agriculture Animal and Plant Health
Inspection Service, the unit principally responsible for surveillance,
prevention, and education activities related to BSE. Member of various
international working groups and advisory committees on TSEs. Author of
numerous articles on the issues.
Alan A. Harris, M.D. Professor of Internal Medicine and Preventive Medicine,
Senior Assistant Chairman, Department of Internal Medicine, Hospital
Epidemiologist, Rush-Presbyterian-St. Luke's Medical Center. Specialist in
public health and foodborne illnesses. Fellow, Infectious Diseases Society
of America. Fellow, American College of Physicians. Member, Society of
Healthcare Epidemiology of America. Author or co-author of more than 140
scientific publications.
Dr. Beat Hörnlimann, MPH. Managing Director, SVISS Consulting, BSE 7192
Ltd., an organization that provides expert advice on public and animal
health, particularly with respect to BSE. Formerly Chief Veterinary Officer,
Public Health Department, Kanton Zug, Switzerland. Led Swiss BSE and scrapie
eradication program and served in numerous other senior-level staff and
advisory positions related to TSEs. Author of a book on prions and prion
diseases in humans and animals.
Dr. David Kessler. Dean, School of Medicine, Yale University and former
Commissioner, U.S. Food and Drug Administration. Author of A Question of
Intent (on federal tobacco regulation efforts) and numerous articles in
major medical journals. Member, Board of Directors, Elizabeth Glaser
Pediatric AIDS Foundation, Doctors of the World, National Center for
Addiction and Substance, Henry Kaiser Family Foundation. Recipient of
numerous medical public service awards, including the American Heart
Association National Public Affairs Special Recognition Award, American
Academy of Pediatrics Excellence in Public Service Award, and American
Cancer Society Medal of Honor.
Dr. Colin Masters. Professor and Head, Department of Pathology, University
of Melbourne. Specialist in neuropathology. Member, numerous national and
international medical professional societies.
Dr. Carols Messuti. Ministry of Livestock, Agriculture, and Fishing,
Government of Uruguay and Delegate to the OIE, the UN's principal agency for
animal diseases.
Dr. Jeffrey W. Savell. Professor, E.M. ?Manny? Rosenthal Chairholder, and
Leader, Meat Science Section, Department of Animal Science, Texas A&M
University. Specialist in meat quality/consistency, food safety and
nutrition. Past President, American Meat Science Association; member,
Institute of Food Technologists, American Society of Animal Science, HACCP
Alliance. Author or co-author of more than 250 articles and co-author of the
Laboratory Manual for Meat Science. Recipient of numerous awards for
research and teaching.
Dr. James Toole. Walter C. Teagle Professor of Neurology, Professor of
Public Health Sciences, and Director, Stroke Research Center, Wake Forest
University School of Medicine. President, International Stroke Society;
member and past-president, World Federation of Neurology; member and
past-president American Neurological Association; fellow, Royal College of
Physicians; master, American College of Physicians. Author of
Cerebrovascular Disorders and over 600 medical textbook chapters; co-editor
Handbook of Clinical Neurology. Former editor, Journal of the Neurological
Sciences.
http://www.mcdonalds.com/corp/values/so ... tific.html
September 13,2004
USDA, FSTS
Docket Clerk
300 12* Street, SW
Room 102, Cotton Annex
Washington, DC 20250
04-021ANPR
04-021ANPR-70
Richard L. Crawford
Re: Docket No: 04-02 1 ANPR Federal Measures to Mitigate BSE Risks:
Considerations
for Further Action
Dear Sir or Madame:
On behalf of McDonald's Corporation, which operates more than 13,000
restaurants in
the United States, we appreciate the opportunity to submit comments to this
very
important Advance Notice of Proposed Rulemaking (ANPRM). 69 Fed. Reg. 42288
(July
14,2004).
In previous comments submitted to FSIS regarding the removal of SRI&,
McDonalds
fully supported this rule and its immediate implementation. The removal of
SRMs from
human food is the primary firewall to protect the US consumer from being
exposed to the
BSE agent. While we applaud the requirement for SRM removal, we feel that it
is
equally important for FSIS to insure that each slaughterplant which
processes cattle have
systems in place which prevent cross contamination between edible tissue and
SRMs.
This should include but not be limited to the use of separate equipment,
such as knives,
blades, etc. where appropriate. In addition, it is also important that
appropriate and
effective disinfection procedures for equipment used to handle SRMs be
developed and
approved for use.
It is our opinion that requiring SRM removal without a procedure to prevent
cross
contamination is inadequate as a protective public health measure. The TSE
agents
@ions) are sticky and highly resistant to disinfection. If SRMs such as
brain and spinal
cord are allowed to contact equipment and other surfaces such as deboning
tables which
then are used to handle and process edible tissue this could allow
contamination and
negates the intention of the ban. This is true not only in plants
slaughtering fed cattle
both under and over 30 months but also in plants slaughtering predominately
older cattle.
It is important that measure be taken to prevent cross contamination between
carcasses
and SRms in the cull plants. McDonalds requires their suppliers to prevent
cross
contamination and audits against certain measurable standards such as
requiring spinal
cord to bc removed on the kill floor. We would be willing to share these
standards with
FSIS as an example.
FSIS Docket No. 04-02 1 ANPR
dooqhl- =w c1qo -
McDonalds again recommends that dura (the covering around the brain and
spinal cord)
be added to the list of SRMs. While skull and vertebral column are included
as SRMs,
dura is not. If dura is not removed prior to processing on the fabrication
floor, it may
come loose and be incorporated into ground product. Bovine dura was never
tested for
infectivity. It was assumed that due to direct contact with spinal cord, it
may serve as a
vehicle to transmit disease. In addition, human dura has been the source of
human to
human transmission of Creutzfeldt-Jakob Disease (CJD). (personal
communication - Dr.
Danny Matthews, UK, VLA) Our ISAC committee recommended that McDonalds add
the removal of dura as a specification in the production of our product.
McDonalds urges the USDA to make the appropriate adjustments in the SRM ban
if new
scientific findings and/or the results of the increased surveillance warrant
a change.
In regards to imported meat products from other countries, McDonalds
suggests that no
SRM exemption be made for countries based on BSE risk. The long incubation
period
and limited surveillance in many countries can limit the ability to
accurately determine
risk. Also, the risk level of a country could potentially change over night
if the trading
patterns of a country changed. It seems logistically impossible to maintain
a system
which could continually monitor the world's trading patterns. In addition,
science has
not provided all of the answers in regards to the transmission of BSE.
Requiring SRMs
to be removed from imported products for human food is prudent. If the US
would wait
until disease is confirmed the exposure would already have occurred.
Thank you for the opportunity to comment on these very important issues.
Richard L. Crawford
Corporat,e Vice President, Government Relations
McDonalds Corporation
1 Kroc Drive
Oak Brook, Illinois 60523
FSIS Docket No. 04-021ANPR
http://www.fda.gov/ohrms/dockets/dailys ... -vol22.pdf
THE USDA JUNE 2004 ENHANCED BSE SURVEILLANCE PROGRAM WAS TERRIBLY FLAWED ;
CDC DR. PAUL BROWN TSE EXPERT COMMENTS 2006
The U.S. Department of Agriculture was quick to assure the public earlier
this week that the third case of mad cow disease did not pose a risk to
them, but what federal officials have not acknowledged is that this latest
case indicates the deadly disease has been circulating in U.S. herds for at
least a decade.
The second case, which was detected last year in a Texas cow and which USDA
officials were reluctant to verify, was approximately 12 years old.
These two cases (the latest was detected in an Alabama cow) present a
picture of the disease having been here for 10 years or so, since it is
thought that cows usually contract the disease from contaminated feed they
consume as calves. The concern is that humans can contract a fatal,
incurable, brain-wasting illness from consuming beef products contaminated
with the mad cow pathogen.
"The fact the Texas cow showed up fairly clearly implied the existence of
other undetected cases," Dr. Paul Brown, former medical director of the
National Institutes of Health's Laboratory for Central Nervous System
Studies and an expert on mad cow-like diseases, told United Press
International. "The question was, 'How many?' and we still can't answer
that."
Brown, who is preparing a scientific paper based on the latest two mad cow
cases to estimate the maximum number of infected cows that occurred in the
United States, said he has "absolutely no confidence in USDA tests before
one year ago" because of the agency's reluctance to retest the Texas cow
that initially tested positive.
USDA officials finally retested the cow and confirmed it was infected seven
months later, but only at the insistence of the agency's inspector general.
"Everything they did on the Texas cow makes everything USDA did before 2005
suspect," Brown said. ...snip...end
http://www.upi.com/ConsumerHealthDaily/ ... 5557-1284r
CDC - Bovine Spongiform Encephalopathy and Variant Creutzfeldt ...
Dr. Paul Brown is Senior Research Scientist in the Laboratory of Central
Nervous System ... Address for correspondence: Paul Brown, Building 36, Room
4A-05, ...
http://www.cdc.gov/ncidod/eid/vol7no1/brown.htm
CDC - Afterthoughts about Bovine Spongiform Encephalopathy and ...
Afterthoughts about Bovine Spongiform Encephalopathy and Variant
Creutzfeldt-Jakob Disease. Paul Brown Senior Investigator, National
Institutes of Health, ...
http://www.cdc.gov/ncidod/eid/vol7no3_supp/brown.htm
December 20,2005
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane
Room 1061
Rockville, MD 20852
Re: Docket No: 2002N-0273 (formerly Docket No. 02N-0273)
Substances Prohibited From Use in Animal Food and Feed
Dear Sir or Madame:
As scientists and Irecognized experts who have worked in the field of TSEs
for
decades, we are deeply concerned by the recent discoveries of indigenous BSE
infected
cattle in North America and appreciate the opportunity to submit comments to
this very
important proposed rule We strongly supported the measures that USDA and FDA
implemented to protect public health after the discovery of the case of
bovine spongiform
encephalopathy (BSE) found in Washington State in 2003. We know of no event
or
discovery since then that could justify relaxing the existing specified risk
material
(SRM) and non-ambulatory bans and surveillance that were implemented at that
time.
Further, we strongly supported the codification of those changes, as well as
additional
measures to strengthen the entire feed and food system. The discovery of
additional
cases of indigenous BSE in North America since that time has validated our
position and
strengthened OUT convictions.
We caution against using the 18 month enhanced surveillance as a
justification to relax or
impede further actions. While this surveillance has not uncovered an
epidemic, it does
not clear the US cattle herd from infection. While it is highly likely that
US and
Canadian cattle were exposed to BSE prior to the 1997 feed ban, we do not
know how
many cattle were infected or how widely the infection was dispersed. BSE
cases are
most likely clustered in time and location, so while enhanced surveillance
provides an 18
month snapshot, it does uot negate the fact that US and Canadian cattle were
exposed to
BSE. We also do not know in any quantitative or controlled way how effective
the feed
ban has been, especially at the farm level. At this point we cannot even
make a thorough
assessment of the USDA surveillance as details such as age, risk category
and regional
distribution have not been released.
see full text 18 pages ;
http://www.fda.gov/ohrms/dockets/docket ... -vol40.pdf
[GAO-05-101 ] Mad Cow Disease: FDA's Management of the Feed Ban Has
Improved, but Oversight Weaknesses Continue to Limit Program Effectiveness
Size: 104986 , Score: 1000 , TEXT , PDF , SUMMARY
http://frwebgate.access.gpo.gov/cgi-bin ... s/data/gao
[2]
[GAO-05-101 ] Mad Cow Disease: FDA's Management of the Feed Ban Has
Improved, but Oversight Weaknesses Continue to Limit Program Effectiveness
Size: 104986 , Score: 1000 , TEXT , PDF , SUMMARY
http://frwebgate.access.gpo.gov/cgi-bin ... s/data/gao
[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
http://www.fsis.usda.gov/OPPDE/Comments ... 5IFA-2.pdf
Subject: Substances Prohibited from Use in Animal Food or Feed, Proposed
Rule, Docket No. 2002N-0273 C-534 VOL 45 (PhRMA) and Entered On February 17,
2006
Date: March 10, 2006 at 5:23 pm PST
Marie A. Vodicka, PhD
Assistant Vice President
Biologics & Blotechnology
Scientlflc & Regulatory Affairs
SCIENCE & REG AFFAIRS
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rrn . 1061
Rackville, MD 20862
Re: Substances Prohibited from Use in Animal Food or Feed, Proposed Rule,
Docket
No. 2002N-0273
February 14, 2006
Dear Sir or Madam :
The Pharmaceutical Research and Manufacturers of America (PhRMA) is
providing
comment to the proposed rules issued. ......
snip...
http://www.fda.gov/ohrms/dockets/docket ... -vol45.pdf
Subject: Docket No: 2002N-0273 (formerly Docket No. 02N-0273) Substances
Prohibited From Use in Animal Food and Feed PAUL BROWN
Date: January 20, 2006 at 9:31 am PST
December 20,2005
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane
Room 1061
Rockville, MD 20852
Re: Docket No: 2002N-0273 (formerly Docket No. 02N-0273)
Substances Prohibited From Use in Animal Food and Feed
Dear Sir or Madame:
As scientists and Irecognized experts who have worked in the field of TSEs
for
decades, we are deeply concerned by the recent discoveries of indigenous BSE
infected
cattle in North America and appreciate the opportunity to submit comments to
this very.........
snip...
Given that BSE can be transmitted to cattle via an
oral route with just .OO1 gram of infected tissue, it may not take much
infectivity to
contaminate feed and keep the disease recycling. ........
http://www.fda.gov/ohrms/dockets/docket ... -vol40.pdf
THE SEVEN SCIENTIST REPORT ***
http://www.fda.gov/ohrms/dockets/docket ... tach-1.pdf
Subject: [Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine
Spongiform Encephalopathy (BSE)
http://www.fsis.usda.gov/OPPDE/Comments ... 0011-1.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
9/13/2005
http://www.fsis.usda.gov/OPPDE/Comments ... 5IFA-2.pdf
Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW BSE SAFEGUARDS (comment submission)
https://web01.aphis.usda.gov/regpublic. ... enDocument
Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL
IMPORTS FROM CANADA
https://web01.aphis.usda.gov/BSEcom.nsf ... AutoFramed
Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION]
http://www.fda.gov/ohrms/dockets/docket ... 000001.txt
Docket Management Docket: 02N-0273 - Substances Prohibited From Use in
Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
Comment Number: EC -10
Accepted - Volume 2
http://www.fda.gov/ohrms/dockets/dailys ... 4be07.html
PART 2
http://www.fda.gov/ohrms/dockets/dailys ... 4be09.html
TSS
