Subject: Calf Claimer Powder with prohibited bovine blood meal which did not
bear the cautionary BSE statement DISTRIBUTION NATIONWIDE
Date: June 13, 2007 at 10:59 am PST
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II
___________________________________
PRODUCT
O-NO-MORE (Formerly ORPHAN-NO-MORE) Calf Claimer Powder, packaged in 11-oz.
bottles, For Animal Use Only. Recall # V-043-2007
CODE
A06
RECALLING FIRM/MANUFACTURER
Springer Magrath Co., Mc Cook, NE, by telephone on January 2, 2007, fax
dated January 9, 2007, by letters on February 22, 2007, March 12, March 14
and March 21, 2007. Firm initiated recall is ongoing.
REASON
The finished product was manufactured with prohibited bovine blood meal and
did not bear the cautionary BSE statement that the product should not be fed
to ruminants.
VOLUME OF PRODUCT IN COMMERCE
Approximately 13,255 bottles
DISTRIBUTION
Nationwide
END OF ENFORCEMENT REPORT FOR JUNE 13, 2007
###
http://www.fda.gov/bbs/topics/enforce/2 ... 01008.html
NATIONAL RENDERERS ASSOCIATION,
Inc. 801 N. Fairfax Street ?? Suite 205 Alexandria, ?? Virginia 22314 Tel:
(703) 683-0155 ?? Fax: (703) 683-2626
March 12, 2007 Docket No. 050-15-1 Regulatory Analysis and Development, PPD,
APHIS Station 3A-03.8 4700 River Road Unit 118 Riverdale, Maryland
20737-1238 Re: Docket No. APHIS-2006-0041, Bovine Spongiform Encephalopathy;
Minimal-Risk Regions; Importation of Live Bovines and Products Derived from
Bovines.
To Whom It May Concern: The National Renderers Association (NRA) references
APHIS’s Docket No. APHIS-2006-0041, the agency’s proposed rule to import
cattle and products. NRA is the international trade association for the
industry that safely and efficiently recycles animal agriculture by-products
into valuable ingredients for the livestock, pet food, chemical and consumer
product industries. NRA represents its members’ interests to Congress,
regulatory and other government agencies, promotes greater use of rendered
products, and fosters the opening and expansion of trade between North
American exporters and foreign buyers. NRA’s membership represents more than
98% of the rendering capacity in both the U.S. and Canada. In the proposed
rule the USDA details the criterion necessary for the importation of bovine
blood products. Specifically the USDA explain: “For all the above three
manners of collection, we would require that the blood be collected in a
closed system or in an otherwise hygienic manner that prevents contamination
of the blood with SRMs.†1
With current line speeds in U.S. beef slaughter facilities a closed
collection system (as described by the USDA in the proposed rule) is not
practical and would be cost prohibitive for production of the feed
ingredients spray dried bovine plasma or blood meal. Requiring such a
collection system would effectively eliminate the supply of feed grade
bovine plasma and blood meal. Restricting these products by requiring blood
to be collected by a closed system would result in significant damage to the
livestock industry both domestically and around the world. Traditional
closed collection systems as suggested in the Proposed Rule may be
appropriate for the collection of Fetal Calf Serum and other specialized
blood products but are impractical for collection of blood used for feed
application. The infective agent responsible for BSE has not been identified
in bovine blood (USDA’s reference, OIE 2005). However, the North American
Spray Dried Blood and Plasma Producers and the NRA recognized the potential
for contamination of raw materials with SRM during collection and subsequent
processing and have developed a series of Manufacturing Guidelines and a
Code of Practice designed to minimize the risk of contamination. These
programs include third party audits by the Facilities Certification
Institute to ensure compliance with the manufacturing guidelines. These
Manufacturing Guidelines have been successfully implemented at the spray
dried blood facilities (including Canada) and the Code of Practice has been
certified at more than 35 high volume rendering plants in the U.S. so far
with many more underway. Many Canadian rendering plants operate under
equally effective HACCP programs. Spray dried plasma is a unique feed
ingredient. There are no effective substitutes for spray dried plasma. It is
important that animal agriculture industry continues to have an adequate
supply of this critical feed ingredient. A number of recognized academic and
industry organizations agree that continued access to adequate supplies of
spray dried bovine blood products is critical. Bovine blood meal represents
a very valuable feed ingredient especially for the rations of the lactating
dairy cow. It provides high levels of lysine that does not degrade in the
rumen. High levels of lysine are necessary to maintain optimum levels of
milk production. If bovine blood meal were removed from use in rations, the
price of porcine blood meal will continue to increase, placing an additional
financial burden on the dairy industry among others. In 2001, the Sparks
Company evaluated the impact of prohibiting cattle derived blood meal in
ruminant diets on behalf of the NRA. In 2000, 1.48 billion pounds of blood
were generated from the slaughter of cattle. A resulting 121.9 million
pounds of cattle blood meal and 49.8 million pounds of mixed species blood
meal were manufactured. Total ruminant containing blood meal produced was
171.7 million pounds, 70% of which was utilized in ruminant diets. The study
determined if the use of blood meal were prohibited in cattle diets, a
product loss of $45.3 million would be realized by the cattle sector.
Additional indirect losses from reduced animal productivity at the farm
level were not considered by the report and are estimated below.
[http://www.renderers.org/economic_impact/index.htm] 2
The unique nutritional properties of blood meal, primarily a high level of
non-degradable lysine, provide a high return when used by dairy producers.
Lysine is considered the first limiting amino acid vital to high milk
production. Unlike poultry and swine, high producing dairy cows can’t
utilize synthetic lysine, thus milk production will drop if this ingredient
is removed. Typically 0.5 pounds/day of dried blood meal is fed to a dairy
cow. A reduction of 4 pounds of milk/cow/day would be expected if blood meal
were no longer utilized in these diets. Using the figure from the Sparks
report that 70% of ruminant blood meal was utilized in dairy rations, an
overall drop in milk production of 9.6 million hundredweight would occur. At
$12/cwt this loss in milk production would reduce dairy farm income by
$115.4 million. Thus, combined losses to the U.S. beef cattle and dairy
sectors would total $160.7 million. It is critical the dairy industry
continues to have access to bovine blood and bovine blood fractions. Over
41% of the heifer calves raised in the U.S. suffer from failure of passive
transfer due to inadequate colostral Ig intake. Approximately 11% of heifer
calves died before weaning, and half of this mortality can be attributed to
inadequate supply of quality colostrum (NAHMS, 1992, 1996). Colostrum is
also recognized as a vector for transmission of a number of disease-causing
organisms, including Mycobacterium paratuberculosis (Johne’s disease).
Published studies indicate bovine serum and fractions thereof are the only
effective alternatives for colostrum (Arthington, et al., 2000 a,b; Quigley
et al., 1998, 2000, 2001; McCoy et al, 1997; Holloway et al, 2002; Poulsen
et al, 2003). If access to these proteins is restricted, there is no
effective alternative to reduce calf mortality or to break these disease
cycles. For a more complete review see the review of Quigley et al. (2004).
Many studies from the involved sectors have been shared with FDA on the
economic and environmental impacts of banning the use of bovine blood meal
in feed, especially representatives from blood processors and the poultry
industry. Collectively, the dual impacts (economic and environmental) could
be very great on the industries. If these products are prohibited from
animal feed, there is reduced market for such products and their disposal
costs increase. This could lead to improper disposal, disposal in landfills,
or by land application on farms. If feeding of blood meal were prohibited
for cows, farmers would either feed higher protein levels and/or milk
additional cows to maintain milk production. Either course of action would
result in increased nitrogen and methane release into the environment. There
is no need to stop the feeding of ruminant blood products to ruminants or
any other animals because there is no science to support such a restriction.
There is no scientific or peer reviewed literature linking the feeding of
bovine blood in the form of blood meal or other blood products in feed to
any risk of BSE transmission in cattle and other ruminants. Bovine blood has
never been implicated in bovine-to-bovine transmission of either natural or
experimental BSE. If there are concerns that some collection methods could
allow small amounts of neural tissue to be collected with the blood,
technology can be employed to remove neural tissue 3
from blood without requiring the closed system or sterile procedures. The
possibility was considered in the Harvard Risk Analysis and not deemed a
significant risk to spread BSE. Products resulting from processes such as
filtering or centrifuging should be allowed to be imported because these
steps would remove any particles or tissue residue. Any unnecessarily
restrictive regulation imposed on minimum risk regions by the U.S. could
easily be applied to U.S. products globally and cause severe problems with
the marketing of blood products which are safe and extremely valuable to
livestock and aquaculture production. The NRA urges the USDA to resume the
import of blood products from minimal risk regions for use in feed
applications when those products are produced in a manner consistent with
the current manufacturing guidelines. Sincerely, David L. Meeker, Ph.D., MBA
Vice President, Scientific Services National Renderers Association 4
http://www.animalprotein.org/news_artic ... e_3-07.pdf
> Bovine blood has never been implicated in bovine-to-bovine transmission of
either natural or experimental BSE
yep, that's what they use to say about the blood from the nvCJD victims too,
however they were wrong about that too ;
Fourth case of transfusion-associated vCJD infection in the United Kingdom
Editorial team ([email protected]), Eurosurveillance
editorial office
A case of variant Creutzfeldt-Jakob disease (vCJD) has recently been
diagnosed in a patient in the United Kingdom (UK), who received a blood
transfusion from a donor who later developed vCJD [1]. This is the fourth
case of probable transfusion transmission of vCJD infection in the UK. Three
of the four recipients developed symptoms of vCJD.
The first symptomatic case of vCJD associated with blood transfusion was
identified in December 2003. This individual developed vCJD six and a half
years after transfusion of red cells donated by an individual who developed
symptoms of vCJD three and a half years after donation.
A second case of vCJD 'infection' was identified a few months later in a
person who had received red cells from a donor who developed symptoms of
vCJD 18 months after donation. This patient (the second case) died from
causes unrelated to vCJD five years after transfusion. Post-mortem
investigations found abnormal prion protein in the spleen and a cervical
lymph node., However, prion protein was not found in the brain, and no
pathological features of vCJD were found.
A third case developed symptoms of vCJD six years after receiving a
transfusion of red blood cells, and died two years and eight months later.
The donor of the blood involved developed vCJD about 20 months after
donating it.
These three cases have been published as case reports and in the findings of
the ongoing collaborative study between the National Blood Services, the
National CJD Surveillance Unit, and the Office for National Statistics. This
study aims to collect evidence about transmission of CJD or vCJD via the
blood supply [2,3,4,5].
The new, fourth case is in a patient who developed symptoms of vCJD eight
and a half years after receiving a transfusion of red blood cells from a
donor who developed vCJD about 17 months after this blood was donated [1].
The donor to this case also donated the vCJD-implicated blood transfused to
the third case. As for all other reported clinical vCJD cases that have been
tested for genotype, this patient is a methionine homozygote at codon 129 of
the prion protein gene. The patient is currently alive.
All four cases had received transfusions of non-leucodepleted red blood
cells between 1996 and 1999. Since October 1999, leucocytes have been
removed from all blood used for transfusion in the UK. The effect of
leucodepletion on the reduction of the risk of transmission of vCJD from an
infective donation is uncertain.
This fourth case of vCJD infection associated with blood transfusion further
increases the level of concern about the risk of vCJD transmission between
humans by blood transfusion, although much remains unknown. This reinforces
the importance of the existing precautions that have been introduced to
reduce the risk of transmission of vCJD infection by blood and blood
products [6]. No cases of vCJD have been associated with fractionated plasma
products. The small group of living recipients of vCJD-implicated blood
transfusion in the UK have been informed of their potential exposure to vCJD
by blood transfusion, asked to take certain precautions to reduce the risk
of onward person-to-person transmission of vCJD during health care, and
offered specialist neurological evaluation and advice.
This article has been adapted from reference 1
References:
Health Protection Agency. Fourth case of variant CJD associated with blood
transfusion (press release). Press release, 18 January 2007.
(http://www.hpa.org.uk/hpa/news/articles ... 8_vCJD.htm
)
Llewelyn CA, Hewitt PE, Knight RSG, Amar K, Cousens S, Mackenzie J, et al.
Possible transmission of variant CJD disease by blood transfusion. Lancet
2004; 363:417-21.
Peden AH, Head MW, Ritchie DL, Bell JE, Ironside JW. Preclinical vCJD after
blood transfusion in a PRNP codon 129 heterozygous patient. Lancet 2004 ;
364: 527-9.
Wroe SJ, Pal S, Siddique D, Hyare H, Macfarlane R, et al Clinical
presentation and pre-mortem diagnosis of blood transfusion-associated
variant CJD. Lancet 2006;368:2061-67.
Hewitt PE, Llewelyn CA, Mackenzie J, Will RG. Creutzfeldt-Jakob disease and
blood transfusion: results of the UK Transfusion Medicine Epidemiology
review study. Vox Sang. 2006;91(3):221-230.
Department of Health [London]. Further precautions to protect blood supply.
Press release 2004/0104, 16 March 2004.
(http://www.dh.gov.uk/PublicationsAndSta ... sReleasesN
otices/fs/en?CONTENT_ID=4076608&chk=MTwE%2Bl)
http://www.eurosurveillance.org/ew/2007/070118.asp
http://bloodindex.org/view_news_zone.php?id=206
HARVARD BSE risk assessment was a joke as well, bought and paid for by your
local cattle dealer i.e. USDA et al
*** Suppressed peer review of Harvard study October 31, 2002 ***
http://www.fsis.usda.gov/oa/topics/BSE_Peer_Review.pdf
[Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine
Spongiform Encephalopathy (BSE) [TSS]
Date: August 26, 2006 at 12:09 pm PST
From: Terry S. Singeltary Sr. [[email protected]]
Sent: Monday, July 24, 2006 1:09 PM
To: FSIS RegulationsComments
Subject: [Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine
Spongiform Encephalopathy (BSE)
Page 1 of 98
8/3/2006
Greetings FSIS,
snip... see full text ;
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 Requirements for the Disposition of
Non-Ambulatory Disabled Cattle
http://www.fsis.usda.gov/OPPDE/Comments ... 5IFA-2.pdf
OIE BSE MRR BOUGHT AND PAID FOR BY YOUR LOCAL CATTLE DEALER
(Adopted by the International Committee of the OIE on 23 May 2006)
11. Information published by the OIE is derived from appropriate
declarations made by the official Veterinary Services of Member Countries.
The OIE is not responsible for inaccurate publication of country disease
status based on inaccurate information or changes in epidemiological status
or other significant events that were not promptly reported to then Central
Bureau............
http://www.oie.int/eng/Session2007/RF2006.pdf
Audit Report
Animal and Plant Health Inspection Service
Bovine Spongiform Encephalopathy (BSE) Surveillance Program  Phase II
and
Food Safety and Inspection Service
Controls Over BSE Sampling, Specified Risk Materials, and Advanced Meat
Recovery Products - Phase III
Report No. 50601-10-KC January 2006
Finding 2 Inherent Challenges in Identifying and Testing High-Risk Cattle
Still Remain
http://www.usda.gov/oig/webdocs/50601-10-KC.pdf
Report to Congressional Requesters:
February 2005:
Mad Cow Disease:
FDA's Management of the Feed Ban Has Improved, but Oversight Weaknesses
Continue to Limit Program Effectiveness:
[Hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-05-101]:
http://www.gao.gov/htext/d05101.html
http://www.gao.gov/highlights/d05101high.pdf
January 2002 MAD COW DISEASE Improvements in the Animal Feed Ban and
Other Regulatory Areas Would Strengthen U.S. Prevention Efforts GAO-02-183
http://www.gao.gov/new.items/d02183.pdf
What Do We Feed to Food-Production Animals? A Review of Animal Feed
Ingredients and Their Potential Impacts on Human Health
Date: May 24, 2007 at 6:59 am PST
http://lists.ifas.ufl.edu/cgi-bin/wa.ex ... =0&P=22301
HAVE THEY EVEN DONE transmission studies of the new atypical BSE or what
they call BASE.
HERE IN THE USA, where BASE was discovered, they find that BASE is more
virulent to humans ;
USA MAD COW STRAIN MORE VIRULENT TO HUMANS THAN UK STRAIN
18 January 2007 - Draft minutes of the SEAC 95 meeting (426 KB) held on 7
December 2006 are now available.
snip...
64. A member noted that at the recent Neuroprion meeting, a study was
presented showing that in transgenic mice BSE passaged in sheep may be more
virulent and infectious to a wider range of species than bovine derived BSE.
Other work presented suggested that BSE and bovine amyloidotic spongiform
encephalopathy (BASE) MAY BE RELATED. A mutation had been identified in the
prion protein gene in an AMERICAN BASE CASE THAT WAS SIMILAR IN NATURE TO A
MUTATION FOUND IN CASES OF SPORADIC CJD.
snip...
http://www.seac.gov.uk/minutes/95.pdf
3:30 Transmission of the Italian Atypical BSE (BASE) in Humanized Mouse
Models Qingzhong Kong, Ph.D., Assistant Professor, Pathology, Case Western
Reserve
University
Bovine Amyloid Spongiform Encephalopathy (BASE) is an atypical BSE strain
discovered recently in Italy, and similar or different atypical BSE cases
were also reported in other countries. The infectivity and phenotypes of
these atypical BSE strains in humans are unknown. In collaboration with
Pierluigi Gambetti, as well as Maria Caramelli and her co-workers, we have
inoculated transgenic mice expressing human prion protein with brain
homogenates from BASE or BSE infected cattle. Our data shows that about half
of the BASE-inoculated mice became infected with an average incubation time
of about 19 months; in contrast, none of the BSE-inoculated mice appear to
be infected after more than 2 years.
***These results indicate that BASE is transmissible to humans and suggest
that BASE is more virulent than
classical BSE in humans.***
6:30 Close of Day One
http://www.healthtech.com/2007/tse/day1.asp
SEE STEADY INCREASE IN SPORADIC CJD IN THE USA FROM
1997 TO 2006. SPORADIC CJD CASES TRIPLED, with phenotype
of 'UNKNOWN' strain growing. ...
http://www.cjdsurveillance.com/resource ... eport.html
There is a growing number of human CJD cases, and they were presented last
week in San Francisco by Luigi Gambatti(?) from his CJD surveillance
collection.
He estimates that it may be up to 14 or 15 persons which display selectively
SPRPSC and practically no detected RPRPSC proteins.
http://www.fda.gov/ohrms/dockets/ac/06/ ... 4240t1.htm
http://www.fda.gov/ohrms/dockets/ac/06/ ... 4240t1.pdf
Research Project: Study of Atypical Bse
Location: Virus and Prion Diseases of Livestock
Project Number: 3625-32000-073-07
Project Type: Specific C/A
Start Date: Sep 15, 2004
End Date: Sep 14, 2007
Objective:
The objective of this cooperative research project with Dr. Maria Caramelli
from the Italian BSE Reference Laboratory in Turin, Italy, is to conduct
comparative studies with the U.S. bovine spongiform encephalopathy (BSE)
isolate and the atypical BSE isolates identified in Italy. The studies will
cover the following areas: 1. Evaluation of present diagnostics tools used
in the U.S. for the detection of atypical BSE cases. 2. Molecular comparison
of the U.S. BSE isolate and other typical BSE isolates with atypical BSE
cases. 3. Studies on transmissibility and tissue distribution of atypical
BSE isolates in cattle and other species.
Approach:
This project will be done as a Specific Cooperative Agreement with the
Italian BSE Reference Laboratory, Istituto Zooprofilattico Sperimentale del
Piemonte, in Turin, Italy. It is essential for the U.S. BSE surveillance
program to analyze the effectiveness of the U.S diagnostic tools for
detection of atypical cases of BSE. Molecular comparisons of the U.S. BSE
isolate with atypical BSE isolates will provide further characterization of
the U.S. BSE isolate. Transmission studies are already underway using brain
homogenates from atypical BSE cases into mice, cattle and sheep. It will be
critical to see whether the atypical BSE isolates behave similarly to
typical BSE isolates in terms of transmissibility and disease pathogenesis.
If transmission occurs, tissue distribution comparisons will be made between
cattle infected with the atypical BSE isolate and the U.S. BSE isolate.
Differences in tissue distribution could require new regulations regarding
specific risk material (SRM) removal.
http://www.ars.usda.gov/research/projec ... _NO=408490
Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518
bear the cautionary BSE statement DISTRIBUTION NATIONWIDE
Date: June 13, 2007 at 10:59 am PST
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II
___________________________________
PRODUCT
O-NO-MORE (Formerly ORPHAN-NO-MORE) Calf Claimer Powder, packaged in 11-oz.
bottles, For Animal Use Only. Recall # V-043-2007
CODE
A06
RECALLING FIRM/MANUFACTURER
Springer Magrath Co., Mc Cook, NE, by telephone on January 2, 2007, fax
dated January 9, 2007, by letters on February 22, 2007, March 12, March 14
and March 21, 2007. Firm initiated recall is ongoing.
REASON
The finished product was manufactured with prohibited bovine blood meal and
did not bear the cautionary BSE statement that the product should not be fed
to ruminants.
VOLUME OF PRODUCT IN COMMERCE
Approximately 13,255 bottles
DISTRIBUTION
Nationwide
END OF ENFORCEMENT REPORT FOR JUNE 13, 2007
###
http://www.fda.gov/bbs/topics/enforce/2 ... 01008.html
NATIONAL RENDERERS ASSOCIATION,
Inc. 801 N. Fairfax Street ?? Suite 205 Alexandria, ?? Virginia 22314 Tel:
(703) 683-0155 ?? Fax: (703) 683-2626
March 12, 2007 Docket No. 050-15-1 Regulatory Analysis and Development, PPD,
APHIS Station 3A-03.8 4700 River Road Unit 118 Riverdale, Maryland
20737-1238 Re: Docket No. APHIS-2006-0041, Bovine Spongiform Encephalopathy;
Minimal-Risk Regions; Importation of Live Bovines and Products Derived from
Bovines.
To Whom It May Concern: The National Renderers Association (NRA) references
APHIS’s Docket No. APHIS-2006-0041, the agency’s proposed rule to import
cattle and products. NRA is the international trade association for the
industry that safely and efficiently recycles animal agriculture by-products
into valuable ingredients for the livestock, pet food, chemical and consumer
product industries. NRA represents its members’ interests to Congress,
regulatory and other government agencies, promotes greater use of rendered
products, and fosters the opening and expansion of trade between North
American exporters and foreign buyers. NRA’s membership represents more than
98% of the rendering capacity in both the U.S. and Canada. In the proposed
rule the USDA details the criterion necessary for the importation of bovine
blood products. Specifically the USDA explain: “For all the above three
manners of collection, we would require that the blood be collected in a
closed system or in an otherwise hygienic manner that prevents contamination
of the blood with SRMs.†1
With current line speeds in U.S. beef slaughter facilities a closed
collection system (as described by the USDA in the proposed rule) is not
practical and would be cost prohibitive for production of the feed
ingredients spray dried bovine plasma or blood meal. Requiring such a
collection system would effectively eliminate the supply of feed grade
bovine plasma and blood meal. Restricting these products by requiring blood
to be collected by a closed system would result in significant damage to the
livestock industry both domestically and around the world. Traditional
closed collection systems as suggested in the Proposed Rule may be
appropriate for the collection of Fetal Calf Serum and other specialized
blood products but are impractical for collection of blood used for feed
application. The infective agent responsible for BSE has not been identified
in bovine blood (USDA’s reference, OIE 2005). However, the North American
Spray Dried Blood and Plasma Producers and the NRA recognized the potential
for contamination of raw materials with SRM during collection and subsequent
processing and have developed a series of Manufacturing Guidelines and a
Code of Practice designed to minimize the risk of contamination. These
programs include third party audits by the Facilities Certification
Institute to ensure compliance with the manufacturing guidelines. These
Manufacturing Guidelines have been successfully implemented at the spray
dried blood facilities (including Canada) and the Code of Practice has been
certified at more than 35 high volume rendering plants in the U.S. so far
with many more underway. Many Canadian rendering plants operate under
equally effective HACCP programs. Spray dried plasma is a unique feed
ingredient. There are no effective substitutes for spray dried plasma. It is
important that animal agriculture industry continues to have an adequate
supply of this critical feed ingredient. A number of recognized academic and
industry organizations agree that continued access to adequate supplies of
spray dried bovine blood products is critical. Bovine blood meal represents
a very valuable feed ingredient especially for the rations of the lactating
dairy cow. It provides high levels of lysine that does not degrade in the
rumen. High levels of lysine are necessary to maintain optimum levels of
milk production. If bovine blood meal were removed from use in rations, the
price of porcine blood meal will continue to increase, placing an additional
financial burden on the dairy industry among others. In 2001, the Sparks
Company evaluated the impact of prohibiting cattle derived blood meal in
ruminant diets on behalf of the NRA. In 2000, 1.48 billion pounds of blood
were generated from the slaughter of cattle. A resulting 121.9 million
pounds of cattle blood meal and 49.8 million pounds of mixed species blood
meal were manufactured. Total ruminant containing blood meal produced was
171.7 million pounds, 70% of which was utilized in ruminant diets. The study
determined if the use of blood meal were prohibited in cattle diets, a
product loss of $45.3 million would be realized by the cattle sector.
Additional indirect losses from reduced animal productivity at the farm
level were not considered by the report and are estimated below.
[http://www.renderers.org/economic_impact/index.htm] 2
The unique nutritional properties of blood meal, primarily a high level of
non-degradable lysine, provide a high return when used by dairy producers.
Lysine is considered the first limiting amino acid vital to high milk
production. Unlike poultry and swine, high producing dairy cows can’t
utilize synthetic lysine, thus milk production will drop if this ingredient
is removed. Typically 0.5 pounds/day of dried blood meal is fed to a dairy
cow. A reduction of 4 pounds of milk/cow/day would be expected if blood meal
were no longer utilized in these diets. Using the figure from the Sparks
report that 70% of ruminant blood meal was utilized in dairy rations, an
overall drop in milk production of 9.6 million hundredweight would occur. At
$12/cwt this loss in milk production would reduce dairy farm income by
$115.4 million. Thus, combined losses to the U.S. beef cattle and dairy
sectors would total $160.7 million. It is critical the dairy industry
continues to have access to bovine blood and bovine blood fractions. Over
41% of the heifer calves raised in the U.S. suffer from failure of passive
transfer due to inadequate colostral Ig intake. Approximately 11% of heifer
calves died before weaning, and half of this mortality can be attributed to
inadequate supply of quality colostrum (NAHMS, 1992, 1996). Colostrum is
also recognized as a vector for transmission of a number of disease-causing
organisms, including Mycobacterium paratuberculosis (Johne’s disease).
Published studies indicate bovine serum and fractions thereof are the only
effective alternatives for colostrum (Arthington, et al., 2000 a,b; Quigley
et al., 1998, 2000, 2001; McCoy et al, 1997; Holloway et al, 2002; Poulsen
et al, 2003). If access to these proteins is restricted, there is no
effective alternative to reduce calf mortality or to break these disease
cycles. For a more complete review see the review of Quigley et al. (2004).
Many studies from the involved sectors have been shared with FDA on the
economic and environmental impacts of banning the use of bovine blood meal
in feed, especially representatives from blood processors and the poultry
industry. Collectively, the dual impacts (economic and environmental) could
be very great on the industries. If these products are prohibited from
animal feed, there is reduced market for such products and their disposal
costs increase. This could lead to improper disposal, disposal in landfills,
or by land application on farms. If feeding of blood meal were prohibited
for cows, farmers would either feed higher protein levels and/or milk
additional cows to maintain milk production. Either course of action would
result in increased nitrogen and methane release into the environment. There
is no need to stop the feeding of ruminant blood products to ruminants or
any other animals because there is no science to support such a restriction.
There is no scientific or peer reviewed literature linking the feeding of
bovine blood in the form of blood meal or other blood products in feed to
any risk of BSE transmission in cattle and other ruminants. Bovine blood has
never been implicated in bovine-to-bovine transmission of either natural or
experimental BSE. If there are concerns that some collection methods could
allow small amounts of neural tissue to be collected with the blood,
technology can be employed to remove neural tissue 3
from blood without requiring the closed system or sterile procedures. The
possibility was considered in the Harvard Risk Analysis and not deemed a
significant risk to spread BSE. Products resulting from processes such as
filtering or centrifuging should be allowed to be imported because these
steps would remove any particles or tissue residue. Any unnecessarily
restrictive regulation imposed on minimum risk regions by the U.S. could
easily be applied to U.S. products globally and cause severe problems with
the marketing of blood products which are safe and extremely valuable to
livestock and aquaculture production. The NRA urges the USDA to resume the
import of blood products from minimal risk regions for use in feed
applications when those products are produced in a manner consistent with
the current manufacturing guidelines. Sincerely, David L. Meeker, Ph.D., MBA
Vice President, Scientific Services National Renderers Association 4
http://www.animalprotein.org/news_artic ... e_3-07.pdf
> Bovine blood has never been implicated in bovine-to-bovine transmission of
either natural or experimental BSE
yep, that's what they use to say about the blood from the nvCJD victims too,
however they were wrong about that too ;
Fourth case of transfusion-associated vCJD infection in the United Kingdom
Editorial team ([email protected]), Eurosurveillance
editorial office
A case of variant Creutzfeldt-Jakob disease (vCJD) has recently been
diagnosed in a patient in the United Kingdom (UK), who received a blood
transfusion from a donor who later developed vCJD [1]. This is the fourth
case of probable transfusion transmission of vCJD infection in the UK. Three
of the four recipients developed symptoms of vCJD.
The first symptomatic case of vCJD associated with blood transfusion was
identified in December 2003. This individual developed vCJD six and a half
years after transfusion of red cells donated by an individual who developed
symptoms of vCJD three and a half years after donation.
A second case of vCJD 'infection' was identified a few months later in a
person who had received red cells from a donor who developed symptoms of
vCJD 18 months after donation. This patient (the second case) died from
causes unrelated to vCJD five years after transfusion. Post-mortem
investigations found abnormal prion protein in the spleen and a cervical
lymph node., However, prion protein was not found in the brain, and no
pathological features of vCJD were found.
A third case developed symptoms of vCJD six years after receiving a
transfusion of red blood cells, and died two years and eight months later.
The donor of the blood involved developed vCJD about 20 months after
donating it.
These three cases have been published as case reports and in the findings of
the ongoing collaborative study between the National Blood Services, the
National CJD Surveillance Unit, and the Office for National Statistics. This
study aims to collect evidence about transmission of CJD or vCJD via the
blood supply [2,3,4,5].
The new, fourth case is in a patient who developed symptoms of vCJD eight
and a half years after receiving a transfusion of red blood cells from a
donor who developed vCJD about 17 months after this blood was donated [1].
The donor to this case also donated the vCJD-implicated blood transfused to
the third case. As for all other reported clinical vCJD cases that have been
tested for genotype, this patient is a methionine homozygote at codon 129 of
the prion protein gene. The patient is currently alive.
All four cases had received transfusions of non-leucodepleted red blood
cells between 1996 and 1999. Since October 1999, leucocytes have been
removed from all blood used for transfusion in the UK. The effect of
leucodepletion on the reduction of the risk of transmission of vCJD from an
infective donation is uncertain.
This fourth case of vCJD infection associated with blood transfusion further
increases the level of concern about the risk of vCJD transmission between
humans by blood transfusion, although much remains unknown. This reinforces
the importance of the existing precautions that have been introduced to
reduce the risk of transmission of vCJD infection by blood and blood
products [6]. No cases of vCJD have been associated with fractionated plasma
products. The small group of living recipients of vCJD-implicated blood
transfusion in the UK have been informed of their potential exposure to vCJD
by blood transfusion, asked to take certain precautions to reduce the risk
of onward person-to-person transmission of vCJD during health care, and
offered specialist neurological evaluation and advice.
This article has been adapted from reference 1
References:
Health Protection Agency. Fourth case of variant CJD associated with blood
transfusion (press release). Press release, 18 January 2007.
(http://www.hpa.org.uk/hpa/news/articles ... 8_vCJD.htm
)
Llewelyn CA, Hewitt PE, Knight RSG, Amar K, Cousens S, Mackenzie J, et al.
Possible transmission of variant CJD disease by blood transfusion. Lancet
2004; 363:417-21.
Peden AH, Head MW, Ritchie DL, Bell JE, Ironside JW. Preclinical vCJD after
blood transfusion in a PRNP codon 129 heterozygous patient. Lancet 2004 ;
364: 527-9.
Wroe SJ, Pal S, Siddique D, Hyare H, Macfarlane R, et al Clinical
presentation and pre-mortem diagnosis of blood transfusion-associated
variant CJD. Lancet 2006;368:2061-67.
Hewitt PE, Llewelyn CA, Mackenzie J, Will RG. Creutzfeldt-Jakob disease and
blood transfusion: results of the UK Transfusion Medicine Epidemiology
review study. Vox Sang. 2006;91(3):221-230.
Department of Health [London]. Further precautions to protect blood supply.
Press release 2004/0104, 16 March 2004.
(http://www.dh.gov.uk/PublicationsAndSta ... sReleasesN
otices/fs/en?CONTENT_ID=4076608&chk=MTwE%2Bl)
http://www.eurosurveillance.org/ew/2007/070118.asp
http://bloodindex.org/view_news_zone.php?id=206
HARVARD BSE risk assessment was a joke as well, bought and paid for by your
local cattle dealer i.e. USDA et al
*** Suppressed peer review of Harvard study October 31, 2002 ***
http://www.fsis.usda.gov/oa/topics/BSE_Peer_Review.pdf
[Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine
Spongiform Encephalopathy (BSE) [TSS]
Date: August 26, 2006 at 12:09 pm PST
From: Terry S. Singeltary Sr. [[email protected]]
Sent: Monday, July 24, 2006 1:09 PM
To: FSIS RegulationsComments
Subject: [Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine
Spongiform Encephalopathy (BSE)
Page 1 of 98
8/3/2006
Greetings FSIS,
snip... see full text ;
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 Requirements for the Disposition of
Non-Ambulatory Disabled Cattle
http://www.fsis.usda.gov/OPPDE/Comments ... 5IFA-2.pdf
OIE BSE MRR BOUGHT AND PAID FOR BY YOUR LOCAL CATTLE DEALER
(Adopted by the International Committee of the OIE on 23 May 2006)
11. Information published by the OIE is derived from appropriate
declarations made by the official Veterinary Services of Member Countries.
The OIE is not responsible for inaccurate publication of country disease
status based on inaccurate information or changes in epidemiological status
or other significant events that were not promptly reported to then Central
Bureau............
http://www.oie.int/eng/Session2007/RF2006.pdf
Audit Report
Animal and Plant Health Inspection Service
Bovine Spongiform Encephalopathy (BSE) Surveillance Program  Phase II
and
Food Safety and Inspection Service
Controls Over BSE Sampling, Specified Risk Materials, and Advanced Meat
Recovery Products - Phase III
Report No. 50601-10-KC January 2006
Finding 2 Inherent Challenges in Identifying and Testing High-Risk Cattle
Still Remain
http://www.usda.gov/oig/webdocs/50601-10-KC.pdf
Report to Congressional Requesters:
February 2005:
Mad Cow Disease:
FDA's Management of the Feed Ban Has Improved, but Oversight Weaknesses
Continue to Limit Program Effectiveness:
[Hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-05-101]:
http://www.gao.gov/htext/d05101.html
http://www.gao.gov/highlights/d05101high.pdf
January 2002 MAD COW DISEASE Improvements in the Animal Feed Ban and
Other Regulatory Areas Would Strengthen U.S. Prevention Efforts GAO-02-183
http://www.gao.gov/new.items/d02183.pdf
What Do We Feed to Food-Production Animals? A Review of Animal Feed
Ingredients and Their Potential Impacts on Human Health
Date: May 24, 2007 at 6:59 am PST
http://lists.ifas.ufl.edu/cgi-bin/wa.ex ... =0&P=22301
HAVE THEY EVEN DONE transmission studies of the new atypical BSE or what
they call BASE.
HERE IN THE USA, where BASE was discovered, they find that BASE is more
virulent to humans ;
USA MAD COW STRAIN MORE VIRULENT TO HUMANS THAN UK STRAIN
18 January 2007 - Draft minutes of the SEAC 95 meeting (426 KB) held on 7
December 2006 are now available.
snip...
64. A member noted that at the recent Neuroprion meeting, a study was
presented showing that in transgenic mice BSE passaged in sheep may be more
virulent and infectious to a wider range of species than bovine derived BSE.
Other work presented suggested that BSE and bovine amyloidotic spongiform
encephalopathy (BASE) MAY BE RELATED. A mutation had been identified in the
prion protein gene in an AMERICAN BASE CASE THAT WAS SIMILAR IN NATURE TO A
MUTATION FOUND IN CASES OF SPORADIC CJD.
snip...
http://www.seac.gov.uk/minutes/95.pdf
3:30 Transmission of the Italian Atypical BSE (BASE) in Humanized Mouse
Models Qingzhong Kong, Ph.D., Assistant Professor, Pathology, Case Western
Reserve
University
Bovine Amyloid Spongiform Encephalopathy (BASE) is an atypical BSE strain
discovered recently in Italy, and similar or different atypical BSE cases
were also reported in other countries. The infectivity and phenotypes of
these atypical BSE strains in humans are unknown. In collaboration with
Pierluigi Gambetti, as well as Maria Caramelli and her co-workers, we have
inoculated transgenic mice expressing human prion protein with brain
homogenates from BASE or BSE infected cattle. Our data shows that about half
of the BASE-inoculated mice became infected with an average incubation time
of about 19 months; in contrast, none of the BSE-inoculated mice appear to
be infected after more than 2 years.
***These results indicate that BASE is transmissible to humans and suggest
that BASE is more virulent than
classical BSE in humans.***
6:30 Close of Day One
http://www.healthtech.com/2007/tse/day1.asp
SEE STEADY INCREASE IN SPORADIC CJD IN THE USA FROM
1997 TO 2006. SPORADIC CJD CASES TRIPLED, with phenotype
of 'UNKNOWN' strain growing. ...
http://www.cjdsurveillance.com/resource ... eport.html
There is a growing number of human CJD cases, and they were presented last
week in San Francisco by Luigi Gambatti(?) from his CJD surveillance
collection.
He estimates that it may be up to 14 or 15 persons which display selectively
SPRPSC and practically no detected RPRPSC proteins.
http://www.fda.gov/ohrms/dockets/ac/06/ ... 4240t1.htm
http://www.fda.gov/ohrms/dockets/ac/06/ ... 4240t1.pdf
Research Project: Study of Atypical Bse
Location: Virus and Prion Diseases of Livestock
Project Number: 3625-32000-073-07
Project Type: Specific C/A
Start Date: Sep 15, 2004
End Date: Sep 14, 2007
Objective:
The objective of this cooperative research project with Dr. Maria Caramelli
from the Italian BSE Reference Laboratory in Turin, Italy, is to conduct
comparative studies with the U.S. bovine spongiform encephalopathy (BSE)
isolate and the atypical BSE isolates identified in Italy. The studies will
cover the following areas: 1. Evaluation of present diagnostics tools used
in the U.S. for the detection of atypical BSE cases. 2. Molecular comparison
of the U.S. BSE isolate and other typical BSE isolates with atypical BSE
cases. 3. Studies on transmissibility and tissue distribution of atypical
BSE isolates in cattle and other species.
Approach:
This project will be done as a Specific Cooperative Agreement with the
Italian BSE Reference Laboratory, Istituto Zooprofilattico Sperimentale del
Piemonte, in Turin, Italy. It is essential for the U.S. BSE surveillance
program to analyze the effectiveness of the U.S diagnostic tools for
detection of atypical cases of BSE. Molecular comparisons of the U.S. BSE
isolate with atypical BSE isolates will provide further characterization of
the U.S. BSE isolate. Transmission studies are already underway using brain
homogenates from atypical BSE cases into mice, cattle and sheep. It will be
critical to see whether the atypical BSE isolates behave similarly to
typical BSE isolates in terms of transmissibility and disease pathogenesis.
If transmission occurs, tissue distribution comparisons will be made between
cattle infected with the atypical BSE isolate and the U.S. BSE isolate.
Differences in tissue distribution could require new regulations regarding
specific risk material (SRM) removal.
http://www.ars.usda.gov/research/projec ... _NO=408490
Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518
