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From: TSS ()
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/2007/ENF01008.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_articles/NRA_Comments_APHIS_Minmal_Risk_Rule_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 (eurosurveillance.weekly@hpa.org.uk), 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/press_releases/2007/070118_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/PublicationsAndStatistics/PressReleases/PressReleasesNotices/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. [flounder9@verizon.net]

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/2006-0011/2006-0011-1.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/03-025IFA/03-025IFA-2.pdf


OIE BSE RECOMMENDATION FOR USA, bought and paid for by your local cattle dealers i.e. USDA et al

Date: May 14, 2007 at 9:00 am PST

http://ranchers.net/forum/viewtopic.php?t=18748

(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.exe?A2=ind0705&L=sanet-mg&T=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/resources-casereport.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/transcripts/1006-4240t1.htm


http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t1.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/projects/projects.htm?ACCN_NO=408490

Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518




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