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Are you the terrorist next door?
Congress recently passed legislation called the Animal Enterprise Terrorism Act (AETA), which can be used to prosecute civil disobedience and speech as “domestic terrorism” when an animal-related business loses profits and property. The Act also protects corporations that pollute and destroy the environment.
I was an ordinary American until November 27, 2006 when I became a terrorist or more accurately what I call a “stand-by terrorist.” Perhaps I cannot truly own this newfound nickname until the government decides to prosecute me for word crimes, if that day ever arrives. Until then, I just think of myself as being on stand-by, just as are most--if not all--Americans, whether they realize it or not.
You may wonder how words can amount to a terrorist act in the land of the free and home of the outspoken. It is not widely known, but Congress recently passed legislation called the Animal Enterprise Terrorism Act (AETA), which can be used to prosecute civil disobedience and speech as “domestic terrorism” when an animal-related business loses profits and property. The Act also protects corporations that pollute and destroy the environment.
You may ask, what does this have to do with me because I’m no nature fan or animal lover? Well, it could eventually have very much to do with you because the AETA--a natural child of the Patriot Act--is likely to be the first of many assaults on the social justice movement in favor of corporations and other moneyed interests. If you think you may want to use your free speech someday to criticize something, anything, then you had better be very concerned.
You should also be concerned about whether law enforcement protects you from the Bin Ladens of the world or fritters away your hard-earned tax dollars investigating pacifists. The American Civil Liberties Union says the FBI uses “counterterrorism resources to monitor and infiltrate (nonviolent) domestic political organizations that criticize business interests and government policies.” An FBI special agent recently told me that planting undercover agents at legal, peaceful events--with hopes that they will somehow learn about illegal activities--is a favored tactic of the bureau.
What are the parameters of the Animal Enterprise Terrorism Act and who could be tangled in its web, slapped with prison time and branded a terrorist? Could Oprah Winfrey--the beloved and successful talk show host--and her former vegetarian guest, Howard Lyman, be prosecuted as terrorists if they were to repeat anti-beef comments made to Winfrey’s 15 million viewers in 1996?
It is indeed possible because the AETA is overbroad, vague and subject to the whims of law enforcement, as evidenced last year when six young, New Jersey website operators became the first individuals convicted on “animal enterprise terrorism” charges. The young people were part of the Stop Huntington Cruelty (SHAC) campaign, which targeted the Huntington Life Sciences (HLS) animal research labs. The website operators did nothing more than assert their First Amendment rights: they posted videotape of tortured dogs inside HLS and reported the legal and illegal handiwork of activists, which eventually caused the corporation to lose profits and to be dropped from the New York Stock Exchange. The FBI were unable to catch the underground activists, so they targeted the website operators, who are serving up to six years in prison for their speech.
If the government fails to catch a thief or saboteur, should it be allowed to pursue the CNN reporter who delivers the news? Or an outspoken op-ed columnist? Or six kids from New Jersey with a website? The AETA ignores Shakespeare’s recommendation, “Don’t shoot the messenger,” potentially stigmatizing a “speaker” with the most heinous, post-9/11 label in America: terrorist.
In 1996, Oprah Winfrey invited ex-cattle rancher Howard Lyman to talk about Mad Cow disease on her television show. Lyman knew first-hand how cows--even diseased ones--were fed being to other cows and how their diets were supplemented with ground-up dogs, cats and road kill. He explained the meat production process, and Winfrey offered that she would never eat another burger. The audience cheered. On the following day, cattle futures plummeted, and the financial disaster was labeled the “Oprah Crash.”
Estimated losses to the beef industry were $10 - $12 million, and a group of cattlemen filed a lawsuit against Winfrey and Lyman under a Texas food disparagement law. They wanted compensation for loss of profits. Winfrey and Lyman won, but only after spending over a million dollars on legal fees. In his book, Mad Cowboy, Lyman says that those who sued “apparently believe that the First Amendment… was not meant to be interpreted so broadly as to allow people to say unpleasant things about beef.”
If Winfrey and Lyman were to make these comments today, and viewers hit the streets, embarking upon civil disobedience, vandalism, even breaking into factory farms and rescuing frightened death row cows from slaughter, could the pair be held liable as AETA conspirators? It is entirely possible.
But nothing this extreme needs to occur because the penalty section of the AETA explicitly states that a person can violate the law and go to prison even if there is no property damage, no loss of profits, no fear to any persons, and no injuries. In other words, if Lyman were to say to Winfrey, “Gee, I hope someone rescues those poor tortured, cows before slaughter,” his comment could be interpreted as a violation of the AETA, more specifically as a “conspiracy to interfere with the operations of an animal enterprise.” Without a transcript from the show, one cannot know what casual exchanges floated between Winfrey and Lyman that day. It may seem far-fetched to envision the pair in prison, branded terrorists--especially since Winfrey is affluent and popular--but it is not far-fetched within the parameters of this poorly drafted legislation, which leaves much open to interpretation by law enforcement and the court system.
Just as the AETA chills speech, it has disturbing ramifications for those who commit slightly illegal misdeeds. The Act can transform misdemeanors into federal crimes, and it can turn ordinary Americans--who, for example, post illegal signs or engage in graffiti--into domestic terrorists.
Let’s assume a high school senior enters a national science fair, and his project involves decapitating live mice. His mother objects to the experiment as cruel and immoral, but the son ignores her. She takes matters into her own hands by stealing the mice and placing them in a loving home, then smashing the remainder of the project and shoving it in the trash. Science fair projects are specifically protected under the AETA, as are vivisection labs, factory farms, slaughterhouses, zoos, furriers and rodeos. The mother has intentionally damaged her son’s animal-related property, which means the U.S. government may arrest her as a terrorist and throw her in jail.
Let’s take another case. A small boy is murdered, and his older sister is devastated. Because law enforcement officers fail to read the killer his rights and bungle other aspects of the case, he goes free. A year later, the sister discovers the killer owns a horse boarding facility in a neighboring state. She drives to the location and paints his fence with the words, “He murdered my little brother. Don’t board your horses here” in attempt to ruin his business and warn customers about the danger. The girl has intentionally caused damage to an animal enterprise. Under the AETA, her graffiti can be prosecuted as a terrorist act.
As a final example, a journalist writes an article about combating the AETA. He suggests peppering the country with signs that read “ALF.” “ALF” is an acronym for the Animal Liberation Front, a group that has vandalized companies that use and kill animals. When “ALF” is scribbled on a fence, building or sign, the FBI is automatically called to investigate. This is routine because the bureau considers the group the number one domestic terrorist threat, even though the ALF has never injured a human or animal.
Investigating the acronym “ALF” would be a laborious task if thousands of signs throughout the country had to be checked. The sign placement strategy would run law enforcement ragged, educate the public about the absurdity of the AETA, and further water down the word “terrorist” so that all Americans could come to realize how they themselves qualify as “terrorists on stand-by.”
At some point, it is likely an animal enterprise owner or employee would play “the fear card.” A butcher, for example, could claim to be frightened by an “ALF” placard adjacent to his shop, alleging an impending attack by angry animal rights activists.
It is a violation of the AETA to intentionally induce fear (of bodily harm) in those associated with an animal enterprise, even when no property is damaged. The “victim”--or the butcher, in this case--would determine what constitutes fear, and it would be easy for him to prove nefarious intentions since everyone knows animal advocates would like to see butchers out of business. Posting illegal signs is common in most neighborhoods, such as when advertising garage sales and political candidates, yet fines are rarely imposed. In the case of “ALF” placards, the “graphic artists” could be arrested as terrorists; the journalist who originated the idea could also be at risk.
It is important to know that AETA terrorism charges cannot be brought against someone when the “target” is unaffiliated with an animal enterprise. If the son’s science project had involved no animals, if the murderer had owned a bicycle shop instead of a horse ranch, and if the illegally posted signs had advertised an estate sale, the FBI would not be called. This demonstrates how the AETA violates the equal protection clause of the Constitution, which states that all people must have equal protection under the law.
Why should biomedical corporations and their executives--as well as other animal industries that bestow hefty campaign donations upon Washington politicos--be provided with a special law? Aren’t there more (or equally) deserving “targets” in need of activist protection, such as abortion clinics, anti-union employers, gay-run businesses and houses of worship? Should there be an Abortion Clinic Terrorism Act, a Union Employer Terrorism Act, and a Gay Community Terrorism Act, among others? Or would these niche laws further impede efforts to identify real terrorism, as the AETA does?
There have been over 13,000 incidents against abortion clinics and doctors since 1977, including seven murders. There have been over 2,100 acts of union violence between 1991 and 2001, including bombings, shootings and near fatal injuries.
In 2004 alone, there were over 4,500 racially motivated incidents in America, while there were another 1,480 based on religious bias and another 1,460 based on sexual orientation. Animal and environmental groups have committed far fewer acts, yet they are pinned with the “terrorist” tag, while those who shoot abortion doctors or burn down synagogues are perceived only as felons.
By the same token, it is unfair to drag a mother off to prison as a terrorist due to bad luck, in that her son decides to embark upon an animal project. If she had destroyed his chemistry vials, she would not be facing terrorism charges. Her compassionate response to animal abuse should make her a hero, not an Al-Qaeda operative. It is dangerous to dilute the word “terrorism” so it loses all meaning, so it describes the most caring and justice-loving members of our society, and so it theoretically applies to the entire citizenry, many who sweat nervously in “standby” waiting rooms.
The AETA may lead to consequences its originators did not foresee. It may embolden aboveground activists who no longer need to limit their activities to that which is legal. After all, they are viewed as terrorists either way. Why should they cheer from the sidelines when they can run with the ball?
Inequitable and oppressive laws can propel pacifists into action, as depicted in the movie, Catch A Fire. The film relates a true story about an apolitical black man who is wrongly accused of being a terrorist by South African authorities in 1980. After enduring arrest and interrogation, he comes to the realization that it is only right to be a “terrorist,” so as to combat the entrenched apartheid of the day. He becomes a rebel fighter, planting an incendiary device at an oil refinery. Ironically, the government--convinced it is keeping him under control by choking him with the heavy hand of the law--wakes him up to injustice and ignites him into action. Animal liberation is no less a noble cause, and a similar result could be expected. Who could be next to catch a fire?
America is about nothing if it is not about fairness and free speech. The AETA does not comport with this image. It is unjust and unconstitutional, and it interferes with the prosecution of real terrorism against the American people.
Once we faced a “red scare”; now we are bombarded with a “green scare.” The time has come to ask yourself: Do you really want to be on stand-by or do you want to take a stand?
And are you now, or could you someday be, the terrorist next door?
________
Charlotte Laws, Ph.D. authors a chapter of the 2006 book, Igniting a Revolution: Voices in Defense of Mother Earth. She is the founder and president of the Los Angeles Directors of Animal Welfare and the League for Earth and Animal Protection. Her website is http://www.CharlotteLaws.org and her blog is http://charlottelaws.typepad.com
You may wonder how words can amount to a terrorist act in the land of the free and home of the outspoken. It is not widely known, but Congress recently passed legislation called the Animal Enterprise Terrorism Act (AETA), which can be used to prosecute civil disobedience and speech as “domestic terrorism” when an animal-related business loses profits and property. The Act also protects corporations that pollute and destroy the environment.
You may ask, what does this have to do with me because I’m no nature fan or animal lover? Well, it could eventually have very much to do with you because the AETA--a natural child of the Patriot Act--is likely to be the first of many assaults on the social justice movement in favor of corporations and other moneyed interests. If you think you may want to use your free speech someday to criticize something, anything, then you had better be very concerned.
You should also be concerned about whether law enforcement protects you from the Bin Ladens of the world or fritters away your hard-earned tax dollars investigating pacifists. The American Civil Liberties Union says the FBI uses “counterterrorism resources to monitor and infiltrate (nonviolent) domestic political organizations that criticize business interests and government policies.” An FBI special agent recently told me that planting undercover agents at legal, peaceful events--with hopes that they will somehow learn about illegal activities--is a favored tactic of the bureau.
What are the parameters of the Animal Enterprise Terrorism Act and who could be tangled in its web, slapped with prison time and branded a terrorist? Could Oprah Winfrey--the beloved and successful talk show host--and her former vegetarian guest, Howard Lyman, be prosecuted as terrorists if they were to repeat anti-beef comments made to Winfrey’s 15 million viewers in 1996?
It is indeed possible because the AETA is overbroad, vague and subject to the whims of law enforcement, as evidenced last year when six young, New Jersey website operators became the first individuals convicted on “animal enterprise terrorism” charges. The young people were part of the Stop Huntington Cruelty (SHAC) campaign, which targeted the Huntington Life Sciences (HLS) animal research labs. The website operators did nothing more than assert their First Amendment rights: they posted videotape of tortured dogs inside HLS and reported the legal and illegal handiwork of activists, which eventually caused the corporation to lose profits and to be dropped from the New York Stock Exchange. The FBI were unable to catch the underground activists, so they targeted the website operators, who are serving up to six years in prison for their speech.
If the government fails to catch a thief or saboteur, should it be allowed to pursue the CNN reporter who delivers the news? Or an outspoken op-ed columnist? Or six kids from New Jersey with a website? The AETA ignores Shakespeare’s recommendation, “Don’t shoot the messenger,” potentially stigmatizing a “speaker” with the most heinous, post-9/11 label in America: terrorist.
In 1996, Oprah Winfrey invited ex-cattle rancher Howard Lyman to talk about Mad Cow disease on her television show. Lyman knew first-hand how cows--even diseased ones--were fed being to other cows and how their diets were supplemented with ground-up dogs, cats and road kill. He explained the meat production process, and Winfrey offered that she would never eat another burger. The audience cheered. On the following day, cattle futures plummeted, and the financial disaster was labeled the “Oprah Crash.”
Estimated losses to the beef industry were $10 - $12 million, and a group of cattlemen filed a lawsuit against Winfrey and Lyman under a Texas food disparagement law. They wanted compensation for loss of profits. Winfrey and Lyman won, but only after spending over a million dollars on legal fees. In his book, Mad Cowboy, Lyman says that those who sued “apparently believe that the First Amendment… was not meant to be interpreted so broadly as to allow people to say unpleasant things about beef.”
If Winfrey and Lyman were to make these comments today, and viewers hit the streets, embarking upon civil disobedience, vandalism, even breaking into factory farms and rescuing frightened death row cows from slaughter, could the pair be held liable as AETA conspirators? It is entirely possible.
But nothing this extreme needs to occur because the penalty section of the AETA explicitly states that a person can violate the law and go to prison even if there is no property damage, no loss of profits, no fear to any persons, and no injuries. In other words, if Lyman were to say to Winfrey, “Gee, I hope someone rescues those poor tortured, cows before slaughter,” his comment could be interpreted as a violation of the AETA, more specifically as a “conspiracy to interfere with the operations of an animal enterprise.” Without a transcript from the show, one cannot know what casual exchanges floated between Winfrey and Lyman that day. It may seem far-fetched to envision the pair in prison, branded terrorists--especially since Winfrey is affluent and popular--but it is not far-fetched within the parameters of this poorly drafted legislation, which leaves much open to interpretation by law enforcement and the court system.
Just as the AETA chills speech, it has disturbing ramifications for those who commit slightly illegal misdeeds. The Act can transform misdemeanors into federal crimes, and it can turn ordinary Americans--who, for example, post illegal signs or engage in graffiti--into domestic terrorists.
Let’s assume a high school senior enters a national science fair, and his project involves decapitating live mice. His mother objects to the experiment as cruel and immoral, but the son ignores her. She takes matters into her own hands by stealing the mice and placing them in a loving home, then smashing the remainder of the project and shoving it in the trash. Science fair projects are specifically protected under the AETA, as are vivisection labs, factory farms, slaughterhouses, zoos, furriers and rodeos. The mother has intentionally damaged her son’s animal-related property, which means the U.S. government may arrest her as a terrorist and throw her in jail.
Let’s take another case. A small boy is murdered, and his older sister is devastated. Because law enforcement officers fail to read the killer his rights and bungle other aspects of the case, he goes free. A year later, the sister discovers the killer owns a horse boarding facility in a neighboring state. She drives to the location and paints his fence with the words, “He murdered my little brother. Don’t board your horses here” in attempt to ruin his business and warn customers about the danger. The girl has intentionally caused damage to an animal enterprise. Under the AETA, her graffiti can be prosecuted as a terrorist act.
As a final example, a journalist writes an article about combating the AETA. He suggests peppering the country with signs that read “ALF.” “ALF” is an acronym for the Animal Liberation Front, a group that has vandalized companies that use and kill animals. When “ALF” is scribbled on a fence, building or sign, the FBI is automatically called to investigate. This is routine because the bureau considers the group the number one domestic terrorist threat, even though the ALF has never injured a human or animal.
Investigating the acronym “ALF” would be a laborious task if thousands of signs throughout the country had to be checked. The sign placement strategy would run law enforcement ragged, educate the public about the absurdity of the AETA, and further water down the word “terrorist” so that all Americans could come to realize how they themselves qualify as “terrorists on stand-by.”
At some point, it is likely an animal enterprise owner or employee would play “the fear card.” A butcher, for example, could claim to be frightened by an “ALF” placard adjacent to his shop, alleging an impending attack by angry animal rights activists.
It is a violation of the AETA to intentionally induce fear (of bodily harm) in those associated with an animal enterprise, even when no property is damaged. The “victim”--or the butcher, in this case--would determine what constitutes fear, and it would be easy for him to prove nefarious intentions since everyone knows animal advocates would like to see butchers out of business. Posting illegal signs is common in most neighborhoods, such as when advertising garage sales and political candidates, yet fines are rarely imposed. In the case of “ALF” placards, the “graphic artists” could be arrested as terrorists; the journalist who originated the idea could also be at risk.
It is important to know that AETA terrorism charges cannot be brought against someone when the “target” is unaffiliated with an animal enterprise. If the son’s science project had involved no animals, if the murderer had owned a bicycle shop instead of a horse ranch, and if the illegally posted signs had advertised an estate sale, the FBI would not be called. This demonstrates how the AETA violates the equal protection clause of the Constitution, which states that all people must have equal protection under the law.
Why should biomedical corporations and their executives--as well as other animal industries that bestow hefty campaign donations upon Washington politicos--be provided with a special law? Aren’t there more (or equally) deserving “targets” in need of activist protection, such as abortion clinics, anti-union employers, gay-run businesses and houses of worship? Should there be an Abortion Clinic Terrorism Act, a Union Employer Terrorism Act, and a Gay Community Terrorism Act, among others? Or would these niche laws further impede efforts to identify real terrorism, as the AETA does?
There have been over 13,000 incidents against abortion clinics and doctors since 1977, including seven murders. There have been over 2,100 acts of union violence between 1991 and 2001, including bombings, shootings and near fatal injuries.
In 2004 alone, there were over 4,500 racially motivated incidents in America, while there were another 1,480 based on religious bias and another 1,460 based on sexual orientation. Animal and environmental groups have committed far fewer acts, yet they are pinned with the “terrorist” tag, while those who shoot abortion doctors or burn down synagogues are perceived only as felons.
By the same token, it is unfair to drag a mother off to prison as a terrorist due to bad luck, in that her son decides to embark upon an animal project. If she had destroyed his chemistry vials, she would not be facing terrorism charges. Her compassionate response to animal abuse should make her a hero, not an Al-Qaeda operative. It is dangerous to dilute the word “terrorism” so it loses all meaning, so it describes the most caring and justice-loving members of our society, and so it theoretically applies to the entire citizenry, many who sweat nervously in “standby” waiting rooms.
The AETA may lead to consequences its originators did not foresee. It may embolden aboveground activists who no longer need to limit their activities to that which is legal. After all, they are viewed as terrorists either way. Why should they cheer from the sidelines when they can run with the ball?
Inequitable and oppressive laws can propel pacifists into action, as depicted in the movie, Catch A Fire. The film relates a true story about an apolitical black man who is wrongly accused of being a terrorist by South African authorities in 1980. After enduring arrest and interrogation, he comes to the realization that it is only right to be a “terrorist,” so as to combat the entrenched apartheid of the day. He becomes a rebel fighter, planting an incendiary device at an oil refinery. Ironically, the government--convinced it is keeping him under control by choking him with the heavy hand of the law--wakes him up to injustice and ignites him into action. Animal liberation is no less a noble cause, and a similar result could be expected. Who could be next to catch a fire?
America is about nothing if it is not about fairness and free speech. The AETA does not comport with this image. It is unjust and unconstitutional, and it interferes with the prosecution of real terrorism against the American people.
Once we faced a “red scare”; now we are bombarded with a “green scare.” The time has come to ask yourself: Do you really want to be on stand-by or do you want to take a stand?
And are you now, or could you someday be, the terrorist next door?
________
Charlotte Laws, Ph.D. authors a chapter of the 2006 book, Igniting a Revolution: Voices in Defense of Mother Earth. She is the founder and president of the Los Angeles Directors of Animal Welfare and the League for Earth and Animal Protection. Her website is http://www.CharlotteLaws.org and her blog is http://charlottelaws.typepad.com
For more information:
http://www.CharlotteLaws.org
Add Your Comments
Comments
(Hide Comments)
January 28, 2007
Greetings APHIS,
I would kindly like to submit the following to ;
BSE; MRR; IMPORTATION OF LIVE BOVINES AND PRODUCTS DERIVED FROM BOVINES [Docket No. APHIS-2006-0041] RIN 0579-AC01
[Federal Register: January 9, 2007 (Volume 72, Number 5)]
[Proposed Rules]
[Page 1101-1129]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09ja07-21]
[[Page 1101]]
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Part III
Department of Agriculture
-----------------------------------------------------------------------
Animal and Plant Health Inspection Service
-----------------------------------------------------------------------
9 CFR Parts 93, 94, 95, and 96
Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of
Live Bovines and Products Derived From Bovines; Proposed Rule
[[Page 1102]]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 93, 94, 95, and 96
[Docket No. APHIS-2006-0041]
RIN 0579-AC01
Bovine Spongiform Encephalopathy; Minimal-Risk Regions;
Importation of Live Bovines and Products Derived From Bovines
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: We are proposing to amend the regulations regarding the
importation of animals and animal products to establish conditions for
the importation of the following commodities from regions that present
a minimal risk of introducing bovine spongiform encephalopathy (BSE)
into the United States: Live bovines for any use born on or after a
date determined by APHIS to be the date of effective enforcement of a
ruminant-to-ruminant feed ban in the region of export; blood and blood
products derived from bovines; and casings and part of the small
intestine derived from bovines. We are proposing these amendments after
conducting a risk assessment and comprehensive evaluation of the issues
that concluded that such bovines and bovine products can be safely
imported under the conditions described in this proposed rule.
DATES: We will consider all comments that we receive on or before March
12, 2007.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to http://www.regulations.gov
, select ``Animal and Plant Health Inspection
Service'' from the agency drop-down menu, then click ``Submit.'' In the
Docket ID column, select APHIS-2006-0041 to submit or view public
comments and to view supporting and related materials available
electronically. Information on using Regulations.gov, including
instructions for accessing documents, submitting comments, and viewing
the docket after the close of the comment period, is available through
the site's ``User Tips'' link.
Postal Mail/Commercial Delivery: Please send four copies
of your comment (an original and three copies) to Docket No. APHIS
2006-0041, Regulatory Analysis and Development, PPD, APHIS, Station 3A-
03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state
that your comment refers to Docket No. APHIS 2006-0041.
Reading Room: You may read any comments that we receive on this
docket in our reading room. The reading room is located in room 1141 of
the USDA South Building, 14th Street and Independence Avenue, SW.,
Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m.,
Monday through Friday, except holidays. To be sure someone is there to
help you, please call (202) 690-2817 before coming.
Other Information: Additional information about APHIS and its
programs is available on the Internet at http://www.aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT: For information regarding ruminant
products, contact Dr. Karen James-Preston, Director, Technical Trade
Services, Animal Products, National Center for Import and Export, VS,
APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231; (301) 734-
4356.
For information concerning live ruminants, contact Dr. Lee Ann
Thomas, Director, Technical Trade Services, Animals, Organisms and
Vectors, and Select Agents, National Center for Import and Export, VS,
APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231; (301) 734-
4356.
For other information concerning this proposed rule, contact Dr.
Lisa Ferguson, Senior Staff Veterinarian, National Center for Animal
Health Programs, VS, APHIS, 4700 River Road Unit 43, Riverdale, MD
20737-1231; (301) 734-6954.
SUPPLEMENTARY INFORMATION:
I. Background ............... snip .................... full text ;
http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/07-17.htm
MY COMMENTS are as follows ;
WITH the new BASE mad cow in the USA bovine, on top of the regular BSE mad cow, I urgently stress that our borders be sealed and that no bovine or ovine, or cervids be traded. THE BSE MRR policy should be repealed, and the old BSE GBR risk assessments be adhered too, and strengthened to include all TSE. ...TSS
18 January 2007 - Draft minutes of the SEAC 95 meeting (426 KB) held on 7
December 2006 are now available.
snip...
ITEM 9 - ANY OTHER BUSINESS
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. A study also demonstrated that in a
mouse model it was possible to alleviate the pathological changes of prion
disease by suppressing expression of the prion protein gene after infection.
http://www.seac.gov.uk/minutes/95.pdf
Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL
IMPORTS FROM CANADA
https://web01.aphis.usda.gov/BSEcom.nsf/0/b78ba677e2b0c12185256dd300649f9d?OpenDocument&AutoFramed
EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of the United States of America (USA)
Summary of the Scientific Report
The European Food Safety Authority and its Scientific Expert Working Group on the Assessment of the Geographical Bovine Spongiform Encephalopathy (BSE) Risk (GBR) were asked by the European Commission (EC) to provide an up-to-date scientific report on the GBR in the United States of America, i.e. the likelihood of the presence of one or more cattle being infected with BSE, pre-clinically as well as clinically, in USA. This scientific report addresses the GBR of USA as assessed in 2004 based on data covering the period 1980-2003.
The BSE agent was probably imported into USA and could have reached domestic cattle in the middle of the eighties. These cattle imported in the mid eighties could have been rendered in the late eighties and therefore led to an internal challenge in the early nineties. It is possible that imported meat and bone meal (MBM) into the USA reached domestic cattle and leads to an internal challenge in the early nineties.
A processing risk developed in the late 80s/early 90s when cattle imports from BSE risk countries were slaughtered or died and were processed (partly) into feed, together with some imports of MBM. This risk continued to exist, and grew significantly in the mid 90’s when domestic cattle, infected by imported MBM, reached processing. Given the low stability of the system, the risk increased over the years with continued imports of cattle and MBM from BSE risk countries.
EFSA concludes that the current GBR level of USA is III, i.e. it is likely but not confirmed that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent. As long as there are no significant changes in rendering or feeding, the stability remains extremely/very unstable. Thus, the probability of cattle to be (pre-clinically or clinically) infected with the BSE-agent persistently increases.
http://www.efsa.europa.eu/en/science/tse_assessments/gbr_assessments/573.html
http://www.efsa.europa.eu/etc/medialib/efsa/science/tse_assessments/gbr_assessments/573.Par.0004.File.dat/sr03_biohaz02_usa_report_v2_en1.pdf
EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of Canada
Summary of the Scientific Report
The European Food Safety Authority and its Scientific Expert Working Group on the Assessment of the Geographical Bovine Spongiform Encephalopathy (BSE) Risk (GBR) were asked to provide an up-to-date scientific report on the GBR in Canada, i.e. the likelihood of the presence of one or more cattle being infected with BSE, pre-clinically as well as clinically, in Canada. This scientific report addresses the GBR of Canada as assessed in 2004 based on data covering the period 1980-2003.
The BSE agent was probably imported into the country middle of the eighties and could have reached domestic cattle in the early nineties. These cattle imported in the mid eighties could have been rendered in the late eighties and therefore led to an internal challenge in the early 90s. It is possible that imported meat and bone meal (MBM) into Canada reached domestic cattle and led to an internal challenge in the early 90s.
A certain risk that BSE-infected cattle entered processing in Canada, and were at least partly rendered for feed, occurred in the early 1990s when cattle imported from UK in the mid 80s could have been slaughtered. This risk continued to exist, and grew significantly in the mid 90’s when domestic cattle, infected by imported MBM, reached processing. Given the low stability of the system, the risk increased over the years with continued imports of cattle and MBM from BSE risk countries.
EFSA concludes that the current GBR level of Canada is III, i.e. it is confirmed at a lower level that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent. As long as the system remains unstable, it is expected that the GBR continues to grow, even if no additional external challenges occur.
http://www.efsa.europa.eu/en/science/tse_assessments/gbr_assessments/564.html
http://www.efsa.europa.eu/etc/medialib/efsa/science/tse_assessments/gbr_assessments/564.Par.0001.File.dat/sr02_biohaz02_canada_report_v2_en1.pdf
EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of Mexico
Summary of the Scientific Report
The European Food Safety Authority and its Scientific Expert Working Group on the Assessment of the Geographical Bovine Spongiform Encephalopathy (BSE) Risk (GBR) were asked by the European Commission (EC) to provide an up-to-date scientific report on the GBR in Mexico, i.e. the likelihood of the presence of one or more cattle being infected with BSE, pre-clinically as well as clinically, in Mexico. This scientific report addresses the GBR of Mexico as assessed in 2004 based on data covering the period 1980-2003.
The BSE agent was probably imported into Mexico and could have reached domestic cattle. These cattle imported could have been rendered and therefore led to an internal challenge in the mid to late 1990s. It is possible that imported meat and bone meal (MBM) into Mexico reached domestic cattle and leads to an internal challenge around 1993.
It is likely that BSE infectivity entered processing at the time of imported ‘at - risk’ MBM (1993) and at the time of slaughter of imported live ‘at - risk’ cattle (mid to late 1990s). The high level of external challenge is maintained throughout the reference period, and the system has not been made stable. Thus it is likely that BSE infectivity was recycled and propagated from approximately 1993. The risk has since grown consistently due to a maintained internal and external challenge and lack of a stable system.
EFSA concludes that the current geographical BSE risk (GBR) level is III, i.e. it is likely but not confirmed that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent. The GBR is likely to increase due to continued internal and external challenge, coupled with a very unstable system.
http://www.efsa.europa.eu/etc/medialib/efsa/science/tse_assessments/gbr_assessments/565.Par.0003.File.dat/sr04_biohaz02_mexico_report_summary_en1.pdf
http://www.efsa.europa.eu/etc/medialib/efsa/science/tse_assessments/gbr_assessments/565.Par.0004.File.dat/sr04_biohaz02_mexico_report_v2_en1.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/view.php?StoryID=20060315-055557-1284r
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
PAUL BROWN COMMENT TO ME ON THIS ISSUE
Tuesday, September 12, 2006 11:10 AM
"Actually, Terry, I have been critical of the USDA handling of the mad cow issue for some years, and with Linda Detwiler and others sent lengthy detailed critiques and recommendations to both the USDA and the Canadian Food Agency."
O.I.E. .......... ??? GOD HELP US! most every country that went by the flawed OIE BSE guidelines, most all became BSE infected countries. ...TSS
sample survey via oie for bse is about 400 test via 100 million cattle, if i am not mistaken. MOST countries that went
by these OIE guidelines all eventually went down with BSE. ...TSS
http://www.oie.int/downld/SC/2005/bse_2005.pdf
THE OIE has now shown they are nothing more than a National Trading Brokerage for all strains of animal TSE.
AS i said before, OIE should hang up there jock strap now, since it appears they will buckle every time a country
makes some political hay about trade protocol, commodities and futures. IF they are not going to be science based, they
should do everyone a favor and dissolve there organization. ...
Page 95 of 98
8/3/2006
WHAT ABOUT RISK FACTORS TO HUMANS FROM ALL OTHER TSEs, WITH RELATIONS TO SRMs ???
a.. BSE OIE
see full text ;
http://p079.ezboard.com/fwolftracksproductionsfrm2.showMessage?topicID=470.topic
IT'S as obvious as day and night, either Larry, Curley, and Mo have been at the helm of the
USDA/APHIS/FSIS/FDA/CDC/NIH et al for many many years, or the incompetence of these agencies are so inept,
either through ignorance and or just too overweight with industry reps., they then should be all done away with and a
single agency brought forth, and if not, how will you correct this ongoing problem ?
http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0612&L=sanet-mg&T=0&P=20678
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0611&L=sanet-mg&T=0&I=-3&P=3381
Subject: [Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine
Spongiform Encephalopathy (BSE)
http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf
BRITISH MEDICAL JOURNAL
BMJ
http://www.bmj.com/cgi/eletters/319/7220/1312/b#EL2
BMJ
http://www.bmj.com/cgi/eletters/320/7226/8/b#EL1
[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
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf
[Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine
Spongiform Encephalopathy (BSE)
http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf
THE SEVEN SCIENTIST REPORT ***
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-EC244-Attach-1.pdf
PAUL BROWN M.D.
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000490-vol40.pdf
9 December 2005
Division of Dockets Management (RFA-305)
SEROLOGICALS CORPORATION
James J. Kramer, Ph.D.
Vice President, Corporate Operations
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000383-01-vol35.pdf
Embassy of Japan
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02N-0273-EC240.htm
Dockets Entered on December 22, 2005
2005D-0330, Guidance for Industry and FDA Review Staff on Collection of
Platelets
by Automated ... EC 203, McDonald's Restaurants Corporation, Vol #:, 34 ...
http://www.fda.gov/ohrms/dockets/dailys/05/Dec05/122205/122205.htm
03-025IF 03-025IF-631 Linda A. Detwiler [PDF]
Page 1. 03-025IF 03-025IF-631 Linda A. Detwiler Page 2. Page 3. Page 4.
Page 5. Page 6. Page 7. Page 8. Page 9. Page 10. Page 11. Page 12.
http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-631.pdf
03-025IF 03-025IF-634 Linda A. Detwiler [PDF]
Page 1. 03-025IF 03-025IF-634 Linda A. Detwiler Page 2.
Page 3. Page 4. Page 5. Page 6. Page 7. Page 8.
http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-634.pdf
Page 1 of 17 9/13/2005 [PDF]
... 2005 6:17 PM To: fsis.regulationscomments [at] fsis.usda.gov Subject: [Docket
No. 03-025IFA]
FSIS Prohibition of the Use of Specified Risk Materials for Human Food ...
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf
03-025IFA 03-025IFA-6 Jason Frost [PDF]
... Zealand Embassy COMMENTS ON FEDERAL REGISTER 9 CFR Parts 309 et al
[Docket No. 03-
025IF] Prohibition of the Use of Specified Risk Materials for Human Food and
...
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-6.pdf
In its opinion of 7-8 December 2000 (EC 2000), the SSC ... [PDF]
Page 1. Linda A. Detwiler, DVM 225 Hwy 35 Red Bank, New Jersey 07701 Phone:
732-741-2290
Cell: 732-580-9391 Fax: 732-741-7751 June 22, 2005 FSIS Docket Clerk US ...
http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-589.pdf
Volume 12, Number 12–December 2006
PERSPECTIVE
On the Question of Sporadic
or Atypical Bovine SpongiformEncephalopathy and
Creutzfeldt-Jakob Disease
Paul Brown,* Lisa M. McShane,† Gianluigi Zanusso,‡ and Linda Detwiler§
Strategies to investigate the possible existence of sporadic
bovine spongiform encephalopathy (BSE) require
systematic testing programs to identify cases in countries
considered to have little or no risk for orally acquired disease,
or to detect a stable occurrence of atypical cases in
countries in which orally acquired disease is disappearing.
To achieve 95% statistical confidence that the prevalence
of sporadic BSE is no greater than 1 per million (i.e., the
annual incidence of sporadic Creutzfeldt-Jakob disease
[CJD] in humans) would require negative tests in 3 million
randomly selected older cattle. A link between BSE and
sporadic CJD has been suggested on the basis of laboratory
studies but is unsupported by epidemiologic observation.
Such a link might yet be established by the discovery
of a specific molecular marker or of particular combinations
of trends over time of typical and atypical BSE and various
subtypes of sporadic CJD, as their numbers are influenced
by a continuation of current public health measures that
exclude high-risk bovine tissues from the animal and
human food chains.
SNIP...
http://www.cdc.gov/ncidod/EID/vol12no12/06-0965.htm?s_cid=eid06_0965_e
3:00 Afternoon Refreshment Break, Poster and Exhibit Viewing in the Exhibit
Hall
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
Calves were challenged by mouth with homogenised brain from confirmed cases of BSE. Some received 300g (3 doses of 100g), some 100g, 10g or 1g. They were then left to develop BSE, but were not subjected to the normal stresses that they might have encountered in a dairy herd. Animals in all four groups developed BSE. There has been a considerable spread of incubation period in some of the groups, but it appears as if those in the 1 and 10g challenge groups most closely fit the picture of incubation periods seen in the epidemic. Experiments in progress indicate that oral infection can occur in some animals with doses as low as 0.01g and 0.001g. .........
http://www.defra.gov.uk/animalh/bse/science-research/pathog.html#dose
and i think, with time, and testing becomes more and more sensitive, we will all be surprised at just how much is too much, and just how young one might be to spread the agent, even as sub-clinical.
IF i remember correctly, the infamous PURINA FEED MILL incident in Gonzales TEXAS,
where at one feeding, those cows could not have consumed more than......or no more than 5.5 grams...etc. so, how many feedings does a feeder and or dairy calf have in there lifespan ? wouldn't you multiply that by those figures by that ??? be a lot of potential mad cow protein IN COMMERCE, and still is in 2006......tss
FDA has determined that each animal could have consumed, at most and in total, five-and-one-half grams - approximately a quarter ounce -- of prohibited material. These animals weigh approximately 600 pounds.
http://www.fda.gov/bbs/topics/NEWS/2001/NEW00752.html
http://www.fda.gov/ora/about/enf_story/archive/2001/ch5/default.htm
Subject: DOCUMENTATION RELATED TO SPECIFIED RISK MATERIALS (SRMs) AND OTHER REGULATIONS FSIS NOTICE 01-07 1/8/07
Date: January 8, 2007 at 9:28 am PST
FSIS NOTICE 01-07 1/8/07
DOCUMENTATION RELATED TO SPECIFIED RISK MATERIALS (SRMs)
AND OTHER REGULATIONS
This notice clarifies how inspection program personnel are to document regulatory noncompliance related to 9 CFR 310.22 for controlling specified risk materials, as well as other regulations
Inspection program personnel are to cite 9 CFR 310.22 in the Relevant Regulation section of every noncompliance report (NR) for an establishment that does not meet the regulatory requirements for controlling SRMs. In addition to selecting 9 CFR 310.22, inspection program personnel are to select all other regulations with which there has been noncompliance.
For example, while performing the 03C02 procedure, the Inspector-in-Charge (IIC) sees spinal cord material on previously cut T-bone steaks that had passed the Critical Control Point (CCP). The IIC cites 9 CFR 417.2(c)(4) and 310.22(b) in the Relevant Regulations section on the Procedure Results NR screen. The IIC notifies the appropriate establishment official of the finding. The IIC also verifies that the corrective actions implemented by the establishment meet the requirements of 9 CFR 417.3(a) before issuing the NR.
Inspection program personnel are to describe the noncompliances in the Narrative Section, block 10, of the NR. The narrative should include a complete description of the SRM noncompliance, including the type of SRM and any other information relevant to the noncompliance. The narrative should also address each of the other regulations that inspection program personnel cite in the Relevant Regulations section on the NR screen. The statements in block 10 of the NR are to support completely and adequately the regulatory noncompliances cited.
For every NR that inspection program personnel issue, it is important that they cite all relevant regulations. These citations provide data that are the basis for critical, risk-based decisions that the FSIS must regularly make when working to ensure that meat and poultry products are safe. Thus, it is not appropriate for inspection program personnel to cite only one regulation if other regulations are also violated by the noncompliance that is the subject of the NR.
Inspection program personnel with technical questions related to the use of PBIS, or who experience technical problems, should contact the FAIM Help Desk at 1-800-473-9135. They should contact the Technical Service Center at 1-800-233-3935 for policy-related questions.
Philip S. Derfler /s/
Assistant Administrator
Office of Policy, Program, and Employee Development
DISTRIBUTION: Inspection Offices; T/A Inspectors; Plant Mgt; TRA; ABB; TSC; Import Offices NOTICE EXPIRES: 2/1/08 OPI: OPPED
http://www.fsis.usda.gov/regulations_&_policies/Notice_01-07/index.asp
> This notice clarifies how inspection program personnel are to document regulatory noncompliance
> related to 9 CFR 310.22 for controlling specified risk materials, as well as other regulations
SO, it's Monday Jan. 8, 2007, in 2006 ALONE, the FDA allowed literally 100s of 1,000s of TONS of ruminant protein to be fed to not only USA cattle and livestock, but it also exported this poison to other parts of the globe as well, and the FSIS is just NOW clarifying how it's inspectors handle SRMs ??? and no SRMs are being fed to cattle in the USA ???
LIKE i said,
IT'S as obvious as day and night, either Larry, Curley, and Mo have been at the helm of the
USDA/APHIS/FSIS/FDA/CDC/NIH et al for many many years, or the incompetence
of these agencies are so inept, either through ignorance and or just too overweight with industry reps.,
they then should be all done away with and a single agency brought forth, and if not, how will you
correct this ongoing problem ?
http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf
http://www.prwatch.org/node/4624
====================================
2006 (partial list of) highly potential mad cow protein in commerce USA
Subject: MAD COW FEED RECALL USA SEPT 6, 2006 1961.72 TONS IN COMMERCE AL,
TN, AND WV
Date: September 6, 2006 at 7:58 am PST
PRODUCT
a) EVSRC Custom dairy feed, Recall # V-130-6;
b) Performance Chick Starter, Recall # V-131-6;
c) Performance Quail Grower, Recall # V-132-6;
d) Performance Pheasant Finisher, Recall # V-133-6.
CODE
None
RECALLING FIRM/MANUFACTURER
Donaldson & Hasenbein/dba J&R Feed Service, Inc., Cullman, AL, by telephone
on June 23, 2006 and by letter dated July 19, 2006. Firm initiated recall is
complete.
REASON
Dairy and poultry feeds were possibly contaminated with ruminant based
protein.
VOLUME OF PRODUCT IN COMMERCE
477.72 tons
DISTRIBUTION
AL
______________________________
PRODUCT
a) Dairy feed, custom, Recall # V-134-6;
b) Custom Dairy Feed with Monensin, Recall # V-135-6.
CODE
None. Bulk product
RECALLING FIRM/MANUFACTURER
Recalling Firm: Burkmann Feed, Greeneville, TN, by Telephone beginning on
June 28, 2006.
Manufacturer: H. J. Baker & Bro., Inc., Albertville, AL. Firm initiated
recall is complete.
REASON
Possible contamination of dairy feeds with ruminant derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
1,484 tons
DISTRIBUTION
TN and WV
http://www.fda.gov/bbs/topics/enforce/2006/ENF00968.html
Subject: MAD COW FEED RECALLS ENFORCEMENT REPORT FOR AUGUST 9, 2006 KY, LA,
MS, AL, GA, AND TN 11,000+ TONS
Date: August 16, 2006 at 9:19 am PST
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II
______________________________
PRODUCT
Bulk custom made dairy feed, Recall # V-115-6
CODE
None
RECALLING FIRM/MANUFACTURER
Hiseville Feed & Seed Co., Hiseville, KY, by telephone and letter on or
about July 14, 2006. FDA initiated recall is ongoing.
REASON
Custom made feeds contain ingredient called Pro-Lak which may contain
ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
Approximately 2,223 tons
DISTRIBUTION
KY
______________________________
PRODUCT
Bulk custom made dairy feed, Recall # V-116-6
CODE
None
RECALLING FIRM/MANUFACTURER
Rips Farm Center, Tollesboro, KY, by telephone and letter on July 14, 2006.
FDA initiated recall is ongoing.
REASON
Custom made feeds contain ingredient called Pro-Lak which may contain
ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
1,220 tons
DISTRIBUTION
KY
______________________________
PRODUCT
Bulk custom made dairy feed, Recall # V-117-6
CODE
None
RECALLING FIRM/MANUFACTURER
Kentwood Co-op, Kentwood, LA, by telephone on June 27, 2006. FDA initiated
recall is completed.
REASON
Possible contamination of animal feed ingredients, including ingredients
that are used in feed for dairy animals, with ruminant derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
40 tons
DISTRIBUTION
LA and MS
______________________________
PRODUCT
Bulk Dairy Feed, Recall V-118-6
CODE
None
RECALLING FIRM/MANUFACTURER
Cal Maine Foods, Inc., Edwards, MS, by telephone on June 26, 2006. FDA
initiated recall is complete.
REASON
Possible contamination of animal feed ingredients, including ingredients
that are used in feed for dairy animals, with ruminant derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
7,150 tons
DISTRIBUTION
MS
______________________________
PRODUCT
Bulk custom dairy pre-mixes, Recall # V-119-6
CODE
None
RECALLING FIRM/MANUFACTURER
Walthall County Co-op, Tylertown, MS, by telephone on June 26, 2006. Firm
initiated recall is complete.
REASON
Possible contamination of dairy animal feeds with ruminant derived meat and
bone meal.
VOLUME OF PRODUCT IN COMMERCE
87 tons
DISTRIBUTION
MS
______________________________
PRODUCT
Bulk custom dairy pre-mixes, Recall # V-120-6
CODE
None
RECALLING FIRM/MANUFACTURER
Ware Milling Inc., Houston, MS, by telephone on June 23, 2006. Firm
initiated recall is complete.
REASON
Possible contamination of dairy animal feeds with ruminant derived meat and
bone meal.
VOLUME OF PRODUCT IN COMMERCE
350 tons
DISTRIBUTION
AL and MS
______________________________
PRODUCT
a) Tucker Milling, LLC Tm 32% Sinking Fish Grower, #2680-Pellet,
50 lb. bags, Recall # V-121-6;
b) Tucker Milling, LLC #31120, Game Bird Breeder Pellet,
50 lb. bags, Recall # V-122-6;
c) Tucker Milling, LLC #31232 Game Bird Grower,
50 lb. bags, Recall # V-123-6;
d) Tucker Milling, LLC 31227-Crumble, Game Bird Starter, BMD
Medicated, 50 lb bags, Recall # V-124-6;
e) Tucker Milling, LLC #31120, Game Bird Breeder, 50 lb bags,
Recall # V-125-6;
f) Tucker Milling, LLC #30230, 30 % Turkey Starter, 50 lb bags,
Recall # V-126-6;
g) Tucker Milling, LLC #30116, TM Broiler Finisher,
50 lb bags, Recall # V-127-6
CODE
All products manufactured from 02/01/2005 until 06/20/2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tucker Milling LLC, Guntersville, AL, by telephone and visit
on June 20, 2006, and by letter on June 23, 2006.
Manufacturer: H. J. Baker and Brothers Inc., Stamford, CT. Firm initiated
recall is ongoing.
REASON
Poultry and fish feeds which were possibly contaminated with ruminant based
protein were not labeled as "Do not feed to ruminants".
VOLUME OF PRODUCT IN COMMERCE
7,541-50 lb bags
DISTRIBUTION
AL, GA, MS, and TN
END OF ENFORCEMENT REPORT FOR AUGUST 9, 2006
###
http://www.fda.gov/bbs/topics/ENFORCE/2006/ENF00964.html
Subject: MAD COW FEED RECALL MI MAMMALIAN PROTEIN VOLUME OF PRODUCT IN
COMMERCE 27,694,240 lbs
Date: August 6, 2006 at 6:14 pm PST
PRODUCT
Bulk custom dairy feds manufactured from concentrates, Recall # V-113-6
CODE
All dairy feeds produced between 2/1/05 and 6/16/06 and containing H. J.
Baker recalled feed products.
RECALLING FIRM/MANUFACTURER
Vita Plus Corp., Gagetown, MI, by visit beginning on June 21, 2006. Firm
initiated recall is complete.
REASON
The feed was manufactured from materials that may have been contaminated
with mammalian protein.
VOLUME OF PRODUCT IN COMMERCE
27,694,240 lbs
DISTRIBUTION
MI
END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006
###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html
Subject: MAD COW FEED RECALL AL AND FL VOLUME OF PRODUCT IN COMMERCE 125
TONS Products manufactured from 02/01/2005 until 06/06/2006
Date: August 6, 2006 at 6:16 pm PST
PRODUCT
a) CO-OP 32% Sinking Catfish, Recall # V-100-6;
b) Performance Sheep Pell W/Decox/A/N, medicated,
net wt. 50 lbs, Recall # V-101-6;
c) Pro 40% Swine Conc Meal -- 50 lb, Recall # V-102-6;
d) CO-OP 32% Sinking Catfish Food Medicated,
Recall # V-103-6;
e) "Big Jim's" BBB Deer Ration, Big Buck Blend,
Recall # V-104-6;
f) CO-OP 40% Hog Supplement Medicated Pelleted,
Tylosin 100 grams/ton, 50 lb. bag, Recall # V-105-6;
g) Pig Starter Pell II, 18% W/MCDX Medicated 282020,
Carbadox -- 0.0055%, Recall # V-106-6;
h) CO-OP STARTER-GROWER CRUMBLES, Complete
Feed for Chickens from Hatch to 20 Weeks, Medicated,
Bacitracin Methylene Disalicylate, 25 and 50 Lbs,
Recall # V-107-6;
i) CO-OP LAYING PELLETS, Complete Feed for Laying
Chickens, Recall # 108-6;
j) CO-OP LAYING CRUMBLES, Recall # V-109-6;
k) CO-OP QUAIL FLIGHT CONDITIONER MEDICATED,
net wt 50 Lbs, Recall # V-110-6;
l) CO-OP QUAIL STARTER MEDICATED, Net Wt. 50 Lbs,
Recall # V-111-6;
m) CO-OP QUAIL GROWER MEDICATED, 50 Lbs,
Recall # V-112-6
CODE
Product manufactured from 02/01/2005 until 06/06/2006
RECALLING FIRM/MANUFACTURER
Alabama Farmers Cooperative, Inc., Decatur, AL, by telephone, fax, email and
visit on June 9, 2006. FDA initiated recall is complete.
REASON
Animal and fish feeds which were possibly contaminated with ruminant based
protein not labeled as "Do not feed to ruminants".
VOLUME OF PRODUCT IN COMMERCE
125 tons
DISTRIBUTION
AL and FL
END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006
###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html
Subject: MAD COW FEED RECALL KY VOLUME OF PRODUCT IN COMMERCE ?????
Date: August 6, 2006 at 6:19 pm PST
PRODUCT
Bulk custom made dairy feed, Recall # V-114-6
CODE
None
RECALLING FIRM/MANUFACTURER
Burkmann Feeds LLC, Glasgow, KY, by letter on July 14, 2006. Firm initiated
recall is ongoing.
REASON
Custom made feeds contain ingredient called Pro-Lak, which may contain
ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
?????
DISTRIBUTION
KY
END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006
###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html
CJD WATCH MESSAGE BOARD
TSS
MAD COW FEED RECALL USA EQUALS 10,878.06 TONS NATIONWIDE
Sun Jul 16, 2006 09:22
71.248.128.67
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
______________________________
PRODUCT
a) PRO-LAK, bulk weight, Protein Concentrate for Lactating Dairy Animals,
Recall # V-079-6;
b) ProAmino II, FOR PREFRESH AND LACTATING COWS, net weight 50lb (22.6 kg),
Recall # V-080-6;
c) PRO-PAK, MARINE & ANIMAL PROTEIN CONCENTRATE FOR USE IN ANIMAL
FEED, Recall # V-081-6;
d) Feather Meal, Recall # V-082-6
CODE
a) Bulk
b) None
c) Bulk
d) Bulk
RECALLING FIRM/MANUFACTURER
H. J. Baker & Bro., Inc., Albertville, AL, by telephone on June 15, 2006 and
by press release on June 16, 2006. Firm initiated recall is ongoing.
REASON
Possible contamination of animal feeds with ruminent derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
10,878.06 tons
DISTRIBUTION
Nationwide
END OF ENFORCEMENT REPORT FOR July 12, 2006
###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00960.html
Subject: MAD COW FEED BAN WARNING LETTER ISSUED MAY 17, 2006
Date: June 27, 2006 at 7:42 am PST
Public Health Service
Food and Drug Administration
New Orleans District
297 Plus Park Blvd.
Nashville, TN 37217
Telephone: 615-781-5380
Fax: 615-781-5391
May 17, 2006
WARNING LETTER NO. 2006-NOL-06
FEDERAL EXPRESS
OVERNIGHT DELIVERY
Mr. William Shirley, Jr., Owner
Louisiana.DBA Riegel By-Products
2621 State Street
Dallas, Texas 75204
Dear Mr. Shirley:
On February 12, 17, 21, and 22, 2006, a U.S. Food & Drug Administration
(FDA) investigator inspected your rendering plant, located at 509 Fortson
Street, Shreveport, Louisiana. The inspection revealed significant
deviations from the requirements set forth in Title 21, Code of Federal
Regulations, Part 589.2000 [21 CFR 589.2000], Animal Proteins Prohibited in
Ruminant Feed. This regulation is intended to prevent the establishment and
amplification of Bovine Spongiform Encephalopathy (BSE). You failed to
follow the requirements of this regulation; products being manufactured and
distributed by your facility are misbranded within the meaning of Section
403(a)(1) [21 USC 343(a)(1)] of the Federal Food, Drug, and Cosmetic Act
(the Act).
Our investigation found you failed to provide measures, including sufficient
written procedures, to prevent commingling or cross-contamination and to
maintain sufficient written procedures [21 CFR 589.2000(e)] because:
You failed to use clean-out procedures or other means adequate to prevent
carryover of protein derived from mammalian tissues into animal protein or
feeds which may be used for ruminants. For example, your facility uses the
same equipment to process mammalian and poultry tissues. However, you use
only hot water to clean the cookers between processing tissues from each
species. You do not clean the auger, hammer mill, grinder, and spouts after
processing mammalian tissues.
You failed to maintain written procedures specifying the clean-out
procedures or other means to prevent carryover of protein derived from
mammalian tissues into feeds which may be used for ruminants.
As a result . the poultry meal you manufacture may contain protein derived
from mammalian tissues prohibited in ruminant feed. Pursuant to 21 CFR
589.2000(e)(1)(i), any products containing or may contain protein derived
from mammalian tissues must be labeled, "Do not feed to cattle or other
ruminants." Since you failed to label a product which may contain protein
derived from mammalian tissues with the required cautionary statement. the
poultry meal is misbranded under Section 403(a)(1) [21 USC 343(a)(1)] of the
Act.
This letter is not intended as an all-inclusive list of violations at your
facility. As a manufacturer of materials intended for animal feed use, you
are responsible for ensuring your overall operation and the products you
manufacture and distribute are in compliance with the law. You should take
prompt action to correct these violations, and you should establish a system
whereby violations do not recur. Failure to promptly correct these
violations may result in regulatory action, such as seizure and/or
injunction, without further notice.
You should notify this office in writing within 15 working days of receiving
this letter, outlining the specific steps you have taken to bring your firm
into compliance with the law. Your response should include an explanation of
each step taken to correct the violations and prevent their recurrence. If
corrective action cannot be completed within 15 working days, state the
reason for the delay and the date by which the corrections will be
completed. Include copies of any available documentation demonstrating
corrections have been made.
Your reply should be directed to Mark W. Rivero, Compliance Officer, U.S.
Food and Drug Administration, 2424 Edenborn Avenue, Suite 410, Metairie,
Louisiana 70001. If you have questions regarding any issue in this letter,
please contact Mr. Rivero at (504) 219-8818, extension 103.
Sincerely,
/S
Carol S. Sanchez
Acting District Director
New Orleans District
http://www.fda.gov/foi/warning_letters/g5883d.htm
look at the table and you'll see that as little as 1 mg (or 0.001 gm) caused
7% (1 of 14) of the cows to come down with BSE;
Risk of oral infection with bovine spongiform encephalopathy agent in
primates
Corinne Ida Lasmézas, Emmanuel Comoy, Stephen Hawkins, Christian Herzog,
Franck Mouthon, Timm Konold, Frédéric Auvré, Evelyne Correia, Nathalie
Lescoutra-Etchegaray, Nicole Salès, Gerald Wells, Paul Brown, Jean-Philippe
Deslys
Summary The uncertain extent of human exposure to bovine spongiform
encephalopathy (BSE)--which can lead to variant Creutzfeldt-Jakob disease
(vCJD)--is compounded by incomplete knowledge about the efficiency of oral
infection and the magnitude of any bovine-to-human biological barrier to
transmission. We therefore investigated oral transmission of BSE to
non-human primates. We gave two macaques a 5 g oral dose of brain homogenate
from a BSE-infected cow. One macaque developed vCJD-like neurological
disease 60 months after exposure, whereas the other remained free of disease
at 76 months. On the basis of these findings and data from other studies, we
made a preliminary estimate of the food exposure risk for man, which
provides additional assurance that existing public health measures can
prevent transmission of BSE to man.
snip...
BSE bovine brain inoculum
100 g 10 g 5 g 1 g 100 mg 10 mg 1 mg 0·1 mg 0·01 mg
Primate (oral route)* 1/2 (50%)
Cattle (oral route)* 10/10 (100%) 7/9 (78%) 7/10 (70%) 3/15 (20%) 1/15 (7%)
1/15 (7%)
RIII mice (ic ip route)* 17/18 (94%) 15/17 (88%) 1/14 (7%)
PrPres biochemical detection
The comparison is made on the basis of calibration of the bovine inoculum
used in our study with primates against a bovine brain inoculum with a
similar PrPres concentration that was
inoculated into mice and cattle.8 *Data are number of animals
positive/number of animals surviving at the time of clinical onset of
disease in the first positive animal (%). The accuracy of
bioassays is generally judged to be about plus or minus 1 log. ic
ip=intracerebral and intraperitoneal.
Table 1: Comparison of transmission rates in primates and cattle infected
orally with similar BSE brain inocula
Published online January 27, 2005
http://www.thelancet.com/journal/journal.isa
Feb 06, 2004 Washington State Investigation—Final Epidemiology Report
http://www.aphis.usda.gov/newsroom/hot_issues/bse/downloads/WashingtonState_epi_final3-04.pdf
Secretary's Advisory Committee Recommendations
Feb 13, 2004 Secretary’s Advisory Committee Report
http://www.aphis.usda.gov/newsroom/hot_issues/bse/downloads/SAC-Report2-13-04.pdf
Feb 02, 2004 International Review Team (IRT) Report
http://www.aphis.usda.gov/newsroom/hot_issues/bse/downloads/US_BSE_Report2-2-04.pdf
http://www.aphis.usda.gov/newsroom/hot_issues/bse/surveillance/bse_disease_surv.shtml
Information on the Washington State Investigation of the BSE-positive Cow
This Office of Inspector General (OIG)
http://www.usda.gov/oig/webdocs/TestimonyBlurb2.pdf
http://www.usda.gov/oig/webdocs/Testimony7-2004.pdf
http://www.usda.gov/oig/webdocs/50601-9-final.pdf
OIG REPORT ON IMPORTS FROM CANADA
http://www.usda.gov/oig/webdocs/33601-01-HY.pdf
Final Case Summeries
May 02, 2006 Alabama BSE Investigation—Final Epidemiology Report
http://www.aphis.usda.gov/newsroom/hot_issues/bse/downloads/EPI_Final5-2-06.pdf
http://www.scienceblog.com/cms/feds_confirm_mad_cow_in_alabama_10204.html
http://www.prwatch.org/node/4624
http://www.microbes.info/forums/index.php?showtopic=306
Aug 30, 2005 USDA Texas BSE Investigation—Final Epidemiology Report
http://www.aphis.usda.gov/newsroom/hot_issues/bse/downloads/bse_final_epi_report8-05.pdf
TSS REPORT ON 2ND TEJAS MAD COW Mon, 22 Nov 2004 17:12:15 -0600 (the one
that did NOT get away, thanks to the Honorable Phyllis Fong)
-------- Original Message --------
Subject: Re: BSE 'INCONCLUSIVE' COW from
TEXAS ???
Date: Mon, 22 Nov 2004 17:12:15 -0600
From: "Terry S. Singeltary Sr."
To: Carla Everett
References: <[log in to unmask]>
<[log in to unmask] us>
Greetings Carla,still hear a rumor;
Texas single beef cow not born in Canada no beef entered the food chain?
and i see the TEXAS department of animal health is ramping up forsomething,
but they forgot a url for update?I HAVE NO ACTUAL CONFIRMATION YET...can you
confirm???terry
==============================
==============================
-------- Original Message --------
Subject: Re: BSE 'INCONCLUSIVE' COW from
TEXAS ???
Date: Fri, 19 Nov 2004 11:38:21 -0600
From: Carla Everett
To: "Terry S. Singeltary Sr."
References: <[log in to unmask]>
The USDA has made a statement, and we are referring all callers to the USDA
web site. We have no informationabout the animal being in Texas. CarlaAt
09:44 AM 11/19/2004, you wrote:>Greetings Carla,>>i am getting
unsubstantiated claims of this BSE 'inconclusive' cow is from>TEXAS. can you
comment on this either way please?>>thank you,>Terry S. Singeltary Sr.>>
===================
===================
-------- Original Message --------
Subject: Re: BSE 'INCONCLUSIVE' COW from
TEXAS ???
Date: Mon, 22 Nov 2004 18:33:20 -0600
From: Carla Everett
To: "Terry S. Singeltary Sr."
References: <[log in to unmask]>
<[log in to unmask] us>
<[log in to unmask]> <[log in to unmask]
us> <[log in to unmask]>
our computer department was working on a place holder we could post USDA's
announcement of any results. There are no results to be announced tonight by
NVSL, so we are back in a waiting mode and will post the USDA
announcementwhen we hear something.At 06:05 PM 11/22/2004, you wrote:>why
was the announcement on your TAHC site removed?>>Bovine Spongiform
Encephalopathy:>November 22: Press Release title here >>star image More BSE
information>>>>terry>>Carla Everett wrote:>>>no confirmation on the U.S.'
inconclusive test...>>no confirmation on location of
animal.>>>>>>
==========================
==========================
THEN, 7+ MONTHS OF COVER-UP BY JOHANN ET AL! no doubt about it now $$$
NO, it's not pretty, hell, im not pretty, but these are the facts, take em
or leave em, however, you cannot change them.
with kindest regards,
I am still sincerely disgusted and tired in sunny Bacliff, Texas USA 77518
Terry S. Singeltary Sr.
FULL 130 LASHINGS TO USDA BY OIG again
http://www.usda.gov/oig/webdocs/50601-10-KC.pdf
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0612&L=sanet-mg&T=0&P=23557
Feb 06, 2004 Washington State Investigation—Final Epidemiology Report
http://www.aphis.usda.gov/newsroom/hot_issues/bse/downloads/WashingtonState_epi_final3-04.pdf
Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION]
http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-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/03/Jan03/012403/8004be07.html
PART 2
http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be09.html
ALSO, now with the 4th documented transmission of vCJD via transfusion, from such a small donor pool, we must ban blood from feed for animal and human consumption ;
Fourth case of transfusion-associated vCJD infection in the United Kingdom
Editorial team (eurosurveillance.weekly [at] hpa.org.uk), Eurosurveillance
editorial office
A suspected 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/PressReleasesN
otices/fs/en?CONTENT_ID=4076608&chk=MTwE%2Bl)
http://www.eurosurveillance.org/ew/2007/070118.asp#4
THE last time a country decided it was o.k. to poison the rest of the world, I thought we had learned something from it, I suppose we have not. that is all in the world the BSE MRR policy is, a legal tool to poison the globe, just for commodities and futures. THIS time however, we are dealing with a more virulent strain of mad cow disease i.e. BASE, and it's been here in the USA for some time if you go back and look at the studies of Mission, Texas from the Scrapie transmission studies there. So I failed to see the logic of this BSE MRR policy, there is nothing science based about it. ...
CONFIDENTIAL BSE POLICY
http://www.bseinquiry.gov.uk/files/yb/1994/05/20002001.pdf
RESTRICTED
MINISTER'S MEETING ON BSE (EXPORTS AND TRIPE) AND ANTHRAX, 14, JULY 1989
http://www.bseinquiry.gov.uk/files/yb/1989/07/14006001.pdf
England worried briefly about infecting other countries
27 Aug 00 confidential correspondence obtained by Terry S. Singeltary Sr.
BSE11/2 020;
SC1337p
DEPARTMENT OF HEALTH AND SOCIAL SECURITY
Richmond House, 79 Whitehall, London SWIA 2NS
Telephone 01-210 3000
From the Chief Medical Officer
Sir Donald Achson KBE DM DSc FRCP FFCM FFOM
Mr K C Meldrum
Chief Veterinary Officer
Ministry of Agriculture, Fisheries and Food
Government Buildings
Hook Rise South
Tolworth
Surbiton
Surrey
KT6 7NG 3 January 1990
Dear Mr Meldrum
BOVINE SPONGIFORM ENCEPHALOPATHY
You will recall that we have previously discussed the potential risks of
BSE occurring in other countries as a result of the continuing export
from the UK of meat and bone that may be contaminated by scrapie or
possibly BSE.
I remain concerned that we are not being consistent in our attempts to
contain the risks of BSE. Having banned the feeding of meat and bone
meal to ruminamts in 1988, we should take steps to prevent these UK
products being fed to ruminants in other countries. This could be
achieved either through a ban on the export of meat and bone meal,
or at least by the proper labelling of these products to make it
absolutely clear they should not be fed to ruminants
[or zoo animals, including rare and endangered primates -- webmaster].
Unless some such action is taken the difficult problems we have faced with BSE
may well occur in other countries who import UK meat and bone meal.
Surely it is short sighted for us to risk being seen in future as
having been responsible for the introduction of BSE to the food chain
in other countries.
I would be very interested to hear how you feel this gap in the present
precautionary measures to eliminate BSE should be closed. We should be
aiming at the global elimination of this new bovine disense. The export
of our meat and bone meal is a continuing risk to other countries.
Yours Sincerely
Donald Acheson
Copy:
Dr Metters
Dr Pickles
90/1.03/1.1
============
BSE13/3 0083
Dr Pickles
From: Dr J S Metters DCM0
International, Prevention and Community Services
7 June 1990
Copies to: Dr McInnes Miss Pease Mr Otley
BSE
1. I spoke to Mr Capstick yesterday. Among other things, he told me
that MAFF are now considering the labelling of animal foodstuffs, and
in particular what detail would be required if such labelling was made
compulsory. Apparently our freedom of action is constrained by EC
Directives [total garbage, MAFF wants to keep exporting -- webmaster], and there is also concern about the level of detail that
should be included in any foodstuff labels.
2. Mr Capstick suggested that this was not an area that DH had a
particular interest. I countered by saying that we supported the
principle of labelling of animal foodstuffs, particularly when these
were going for export.
3. I also thanked him for keeping us informed, in a way that I hope
encourage further communication of MAFF's internal deliberations.
J S METTERS
Room 509
Richmond House
Ext. 5591 92/YdeS 90/6.7/5.1
http://www.mad-cow.org/00/aug00_last_news.html#fff
http://www.bseinquiry.gov.uk/files/yb/1990/01/03001001.pdf
> Transmission Studies
>
> Mule deer transmissions of CWD were by intracerebral inoculation and
> compared with natural cases
>
> {the following was written but with a single line marked through it
''first
> passage (by this route)}...TSS
>
> resulted in a more rapidly progressive clinical disease with repeated
> episodes of synocopy ending in coma. One control animal became affected,
it
> is believed through contamination of inoculum (?saline). Further CWD
> transmissions were carried out by Dick Marsh into ferret, mink and
squirrel
> monkey. Transmission occurred in ALL of these species with the shortest
> incubation period in the ferret.
>
> snip...
>
> Appendix 3
>
> VISIT TO USA - DR A E WRATHALL - INFO OH BSE AND SCRAPIE
>
> 1. Dr Clark lately of the Scrapie Research Unit, Mission Texas has
> successfully transmitted ovine and caprine scrapie to cattle. The
> experimental results have not been published but there are plans to do
> this. This work was initiated in 1978. A summary of it is:-
>
> Expt A
> 6 Her x Jer calves born in 1978 were inoculated as follows with
> a 2nd Suffolk scrapie passage:-
>
>
> i/c 1ml; i/m, 5ml; s/c 5ml; oral 30ml.
> 1/6 went down after 48 months with a scrapie/BSE-like disease.
>
> Expt B
> 6 Her or Jer or HxJ calves were inoculated with angora Goat
> virus 2/6 went down similarly after 36 months.
>
> Expt C
> Mice inoculated from brains of calves/cattle in expts A • B
> were resistant, only 1/20 going down with scrapie and this was the
> reason given for not publishing.
>
> Diagnosis in A, B, C was by histopath. No reports on SAT were given.
>
> 2. Dr Warren Foote indicated success so far in eliminating scrapie in
> offspring from experimentally- (and naturally) infected sheep by ET.
> He had found difficulty in obtaining embryos from naturally infected
> sheep (cf SPA).
>
> 3. Prof. A Robertson gave a brief account of BSE. The US approach was to
> accord it a very low profile indeed. Dr A Thiermann showed the
> picture in the "Independent" with cattle being incinerated and thought
> this was a fanatical incident to be avoided in the US at all costs.
> BSE was not reported in USA.
>
>
> 4. Scrapie incidents (ie affected flocks) have shown a dramatic increase
> since 1978. In 1953 when the National Control Scheme was started
> there were 10-14 incidents, in 1978 - 1 and in 1988 so far 60.
>
> 5. Scrapie agent was reported to have been isolated from a solitary
> fetus.
>
> 6. A western blotting diagnostic technique (? on PrP) shows some promise.
>
> 7. Results of a questionnaire sent to 33 states on the subject of the
> national sheep scrapie programme survey indicated
>
>
> 17/33 wished to drop it
>
> 6/33 wished to develop it
>
> 8/33 had few sheep and were neutral
>
>
> Information obtained from Dr Wrathall's notes of a meeting of the U.S.
> Animal Health Association at Little Rock, Arkansas Nov. 1988.
>
>
>
> 33
>
> end...TSS
>
>
> >> Differences in tissue distribution could require new regulations
> >> regarding specific risk material (SRM) removal.
>
>
> snip...end
>
> full text 33 PAGES ;
>
>
> http://www.bseinquiry.gov.uk/files/mb/m11b/tab01.pdf
>
> http://www.bseinquiry.gov.uk/files/yb/1988/10/00001001.pdf
>
>
> It was, however, performed in the USA in 1979, when it was shown that
cattle
> inoculated with the scrapie agent endemic in the flock of Suffolk sheep at
> the United States Department of Agriculture in Mission, Texas, developed a
> TSE quite unlike BSE. 32 The findings of the initial transmission, though
> not of the clinical or neurohistological examination, were communicated in
> October 1988 to Dr Watson, Director of the CVL, following a visit by Dr
> Wrathall, one of the project leaders in the Pathology Department of the
CVL,
> to the United States Department of Agriculture. 33 The results were not
> published at this point, since the attempted transmission to mice from the
> experimental cow brain had been inconclusive. The results of the clinical
> and histological differences between scrapie-affected sheep and cattle
were
> published in 1995. Similar studies in which cattle were inoculated
> intracerebrally with scrapie inocula derived from a number of
> scrapie-affected sheep of different breeds and from different States, were
> carried out at the US National Animal Disease Centre. 34 The results,
> published in 1994, showed that this source of scrapie agent, though
> pathogenic for cattle, did not produce the same clinical signs of brain
> lesions characteristic of BSE.
>
> http://www.bseinquiry.gov.uk/
>
>
>
> 1: J Infect Dis. 1994 Apr;169(4):814-20.
>
>
> Intracerebral transmission of scrapie to cattle.
>
> Cutlip RC, Miller JM, Race RE, Jenny AL, Katz JB, Lehmkuhl HD, DeBey BM,
> Robinson MM.
>
> USDA, Agriculture Research Service, National Animal Disease Center, Ames,
IA
> 50010.
>
> To determine if sheep scrapie agent(s) in the United States would induce a
> disease in cattle resembling bovine spongiform encephalopathy, 18 newborn
> calves were inoculated intracerebrally with a pooled suspension of brain
> from 9 sheep with scrapie. Half of the calves were euthanatized 1 year
after
> inoculation. All calves kept longer than 1 year became severely lethargic
> and demonstrated clinical signs of motor neuron dysfunction that were
> manifest as progressive stiffness, posterior pares
Greetings APHIS,
I would kindly like to submit the following to ;
BSE; MRR; IMPORTATION OF LIVE BOVINES AND PRODUCTS DERIVED FROM BOVINES [Docket No. APHIS-2006-0041] RIN 0579-AC01
[Federal Register: January 9, 2007 (Volume 72, Number 5)]
[Proposed Rules]
[Page 1101-1129]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09ja07-21]
[[Page 1101]]
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Part III
Department of Agriculture
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Animal and Plant Health Inspection Service
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9 CFR Parts 93, 94, 95, and 96
Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of
Live Bovines and Products Derived From Bovines; Proposed Rule
[[Page 1102]]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 93, 94, 95, and 96
[Docket No. APHIS-2006-0041]
RIN 0579-AC01
Bovine Spongiform Encephalopathy; Minimal-Risk Regions;
Importation of Live Bovines and Products Derived From Bovines
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: We are proposing to amend the regulations regarding the
importation of animals and animal products to establish conditions for
the importation of the following commodities from regions that present
a minimal risk of introducing bovine spongiform encephalopathy (BSE)
into the United States: Live bovines for any use born on or after a
date determined by APHIS to be the date of effective enforcement of a
ruminant-to-ruminant feed ban in the region of export; blood and blood
products derived from bovines; and casings and part of the small
intestine derived from bovines. We are proposing these amendments after
conducting a risk assessment and comprehensive evaluation of the issues
that concluded that such bovines and bovine products can be safely
imported under the conditions described in this proposed rule.
DATES: We will consider all comments that we receive on or before March
12, 2007.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to http://www.regulations.gov
, select ``Animal and Plant Health Inspection
Service'' from the agency drop-down menu, then click ``Submit.'' In the
Docket ID column, select APHIS-2006-0041 to submit or view public
comments and to view supporting and related materials available
electronically. Information on using Regulations.gov, including
instructions for accessing documents, submitting comments, and viewing
the docket after the close of the comment period, is available through
the site's ``User Tips'' link.
Postal Mail/Commercial Delivery: Please send four copies
of your comment (an original and three copies) to Docket No. APHIS
2006-0041, Regulatory Analysis and Development, PPD, APHIS, Station 3A-
03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state
that your comment refers to Docket No. APHIS 2006-0041.
Reading Room: You may read any comments that we receive on this
docket in our reading room. The reading room is located in room 1141 of
the USDA South Building, 14th Street and Independence Avenue, SW.,
Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m.,
Monday through Friday, except holidays. To be sure someone is there to
help you, please call (202) 690-2817 before coming.
Other Information: Additional information about APHIS and its
programs is available on the Internet at http://www.aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT: For information regarding ruminant
products, contact Dr. Karen James-Preston, Director, Technical Trade
Services, Animal Products, National Center for Import and Export, VS,
APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231; (301) 734-
4356.
For information concerning live ruminants, contact Dr. Lee Ann
Thomas, Director, Technical Trade Services, Animals, Organisms and
Vectors, and Select Agents, National Center for Import and Export, VS,
APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231; (301) 734-
4356.
For other information concerning this proposed rule, contact Dr.
Lisa Ferguson, Senior Staff Veterinarian, National Center for Animal
Health Programs, VS, APHIS, 4700 River Road Unit 43, Riverdale, MD
20737-1231; (301) 734-6954.
SUPPLEMENTARY INFORMATION:
I. Background ............... snip .................... full text ;
http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/07-17.htm
MY COMMENTS are as follows ;
WITH the new BASE mad cow in the USA bovine, on top of the regular BSE mad cow, I urgently stress that our borders be sealed and that no bovine or ovine, or cervids be traded. THE BSE MRR policy should be repealed, and the old BSE GBR risk assessments be adhered too, and strengthened to include all TSE. ...TSS
18 January 2007 - Draft minutes of the SEAC 95 meeting (426 KB) held on 7
December 2006 are now available.
snip...
ITEM 9 - ANY OTHER BUSINESS
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. A study also demonstrated that in a
mouse model it was possible to alleviate the pathological changes of prion
disease by suppressing expression of the prion protein gene after infection.
http://www.seac.gov.uk/minutes/95.pdf
Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL
IMPORTS FROM CANADA
https://web01.aphis.usda.gov/BSEcom.nsf/0/b78ba677e2b0c12185256dd300649f9d?OpenDocument&AutoFramed
EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of the United States of America (USA)
Summary of the Scientific Report
The European Food Safety Authority and its Scientific Expert Working Group on the Assessment of the Geographical Bovine Spongiform Encephalopathy (BSE) Risk (GBR) were asked by the European Commission (EC) to provide an up-to-date scientific report on the GBR in the United States of America, i.e. the likelihood of the presence of one or more cattle being infected with BSE, pre-clinically as well as clinically, in USA. This scientific report addresses the GBR of USA as assessed in 2004 based on data covering the period 1980-2003.
The BSE agent was probably imported into USA and could have reached domestic cattle in the middle of the eighties. These cattle imported in the mid eighties could have been rendered in the late eighties and therefore led to an internal challenge in the early nineties. It is possible that imported meat and bone meal (MBM) into the USA reached domestic cattle and leads to an internal challenge in the early nineties.
A processing risk developed in the late 80s/early 90s when cattle imports from BSE risk countries were slaughtered or died and were processed (partly) into feed, together with some imports of MBM. This risk continued to exist, and grew significantly in the mid 90’s when domestic cattle, infected by imported MBM, reached processing. Given the low stability of the system, the risk increased over the years with continued imports of cattle and MBM from BSE risk countries.
EFSA concludes that the current GBR level of USA is III, i.e. it is likely but not confirmed that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent. As long as there are no significant changes in rendering or feeding, the stability remains extremely/very unstable. Thus, the probability of cattle to be (pre-clinically or clinically) infected with the BSE-agent persistently increases.
http://www.efsa.europa.eu/en/science/tse_assessments/gbr_assessments/573.html
http://www.efsa.europa.eu/etc/medialib/efsa/science/tse_assessments/gbr_assessments/573.Par.0004.File.dat/sr03_biohaz02_usa_report_v2_en1.pdf
EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of Canada
Summary of the Scientific Report
The European Food Safety Authority and its Scientific Expert Working Group on the Assessment of the Geographical Bovine Spongiform Encephalopathy (BSE) Risk (GBR) were asked to provide an up-to-date scientific report on the GBR in Canada, i.e. the likelihood of the presence of one or more cattle being infected with BSE, pre-clinically as well as clinically, in Canada. This scientific report addresses the GBR of Canada as assessed in 2004 based on data covering the period 1980-2003.
The BSE agent was probably imported into the country middle of the eighties and could have reached domestic cattle in the early nineties. These cattle imported in the mid eighties could have been rendered in the late eighties and therefore led to an internal challenge in the early 90s. It is possible that imported meat and bone meal (MBM) into Canada reached domestic cattle and led to an internal challenge in the early 90s.
A certain risk that BSE-infected cattle entered processing in Canada, and were at least partly rendered for feed, occurred in the early 1990s when cattle imported from UK in the mid 80s could have been slaughtered. This risk continued to exist, and grew significantly in the mid 90’s when domestic cattle, infected by imported MBM, reached processing. Given the low stability of the system, the risk increased over the years with continued imports of cattle and MBM from BSE risk countries.
EFSA concludes that the current GBR level of Canada is III, i.e. it is confirmed at a lower level that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent. As long as the system remains unstable, it is expected that the GBR continues to grow, even if no additional external challenges occur.
http://www.efsa.europa.eu/en/science/tse_assessments/gbr_assessments/564.html
http://www.efsa.europa.eu/etc/medialib/efsa/science/tse_assessments/gbr_assessments/564.Par.0001.File.dat/sr02_biohaz02_canada_report_v2_en1.pdf
EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of Mexico
Summary of the Scientific Report
The European Food Safety Authority and its Scientific Expert Working Group on the Assessment of the Geographical Bovine Spongiform Encephalopathy (BSE) Risk (GBR) were asked by the European Commission (EC) to provide an up-to-date scientific report on the GBR in Mexico, i.e. the likelihood of the presence of one or more cattle being infected with BSE, pre-clinically as well as clinically, in Mexico. This scientific report addresses the GBR of Mexico as assessed in 2004 based on data covering the period 1980-2003.
The BSE agent was probably imported into Mexico and could have reached domestic cattle. These cattle imported could have been rendered and therefore led to an internal challenge in the mid to late 1990s. It is possible that imported meat and bone meal (MBM) into Mexico reached domestic cattle and leads to an internal challenge around 1993.
It is likely that BSE infectivity entered processing at the time of imported ‘at - risk’ MBM (1993) and at the time of slaughter of imported live ‘at - risk’ cattle (mid to late 1990s). The high level of external challenge is maintained throughout the reference period, and the system has not been made stable. Thus it is likely that BSE infectivity was recycled and propagated from approximately 1993. The risk has since grown consistently due to a maintained internal and external challenge and lack of a stable system.
EFSA concludes that the current geographical BSE risk (GBR) level is III, i.e. it is likely but not confirmed that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent. The GBR is likely to increase due to continued internal and external challenge, coupled with a very unstable system.
http://www.efsa.europa.eu/etc/medialib/efsa/science/tse_assessments/gbr_assessments/565.Par.0003.File.dat/sr04_biohaz02_mexico_report_summary_en1.pdf
http://www.efsa.europa.eu/etc/medialib/efsa/science/tse_assessments/gbr_assessments/565.Par.0004.File.dat/sr04_biohaz02_mexico_report_v2_en1.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/view.php?StoryID=20060315-055557-1284r
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
PAUL BROWN COMMENT TO ME ON THIS ISSUE
Tuesday, September 12, 2006 11:10 AM
"Actually, Terry, I have been critical of the USDA handling of the mad cow issue for some years, and with Linda Detwiler and others sent lengthy detailed critiques and recommendations to both the USDA and the Canadian Food Agency."
O.I.E. .......... ??? GOD HELP US! most every country that went by the flawed OIE BSE guidelines, most all became BSE infected countries. ...TSS
sample survey via oie for bse is about 400 test via 100 million cattle, if i am not mistaken. MOST countries that went
by these OIE guidelines all eventually went down with BSE. ...TSS
http://www.oie.int/downld/SC/2005/bse_2005.pdf
THE OIE has now shown they are nothing more than a National Trading Brokerage for all strains of animal TSE.
AS i said before, OIE should hang up there jock strap now, since it appears they will buckle every time a country
makes some political hay about trade protocol, commodities and futures. IF they are not going to be science based, they
should do everyone a favor and dissolve there organization. ...
Page 95 of 98
8/3/2006
WHAT ABOUT RISK FACTORS TO HUMANS FROM ALL OTHER TSEs, WITH RELATIONS TO SRMs ???
a.. BSE OIE
see full text ;
http://p079.ezboard.com/fwolftracksproductionsfrm2.showMessage?topicID=470.topic
IT'S as obvious as day and night, either Larry, Curley, and Mo have been at the helm of the
USDA/APHIS/FSIS/FDA/CDC/NIH et al for many many years, or the incompetence of these agencies are so inept,
either through ignorance and or just too overweight with industry reps., they then should be all done away with and a
single agency brought forth, and if not, how will you correct this ongoing problem ?
http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0612&L=sanet-mg&T=0&P=20678
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0611&L=sanet-mg&T=0&I=-3&P=3381
Subject: [Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine
Spongiform Encephalopathy (BSE)
http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf
BRITISH MEDICAL JOURNAL
BMJ
http://www.bmj.com/cgi/eletters/319/7220/1312/b#EL2
BMJ
http://www.bmj.com/cgi/eletters/320/7226/8/b#EL1
[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
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf
[Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine
Spongiform Encephalopathy (BSE)
http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf
THE SEVEN SCIENTIST REPORT ***
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-EC244-Attach-1.pdf
PAUL BROWN M.D.
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000490-vol40.pdf
9 December 2005
Division of Dockets Management (RFA-305)
SEROLOGICALS CORPORATION
James J. Kramer, Ph.D.
Vice President, Corporate Operations
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000383-01-vol35.pdf
Embassy of Japan
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02N-0273-EC240.htm
Dockets Entered on December 22, 2005
2005D-0330, Guidance for Industry and FDA Review Staff on Collection of
Platelets
by Automated ... EC 203, McDonald's Restaurants Corporation, Vol #:, 34 ...
http://www.fda.gov/ohrms/dockets/dailys/05/Dec05/122205/122205.htm
03-025IF 03-025IF-631 Linda A. Detwiler [PDF]
Page 1. 03-025IF 03-025IF-631 Linda A. Detwiler Page 2. Page 3. Page 4.
Page 5. Page 6. Page 7. Page 8. Page 9. Page 10. Page 11. Page 12.
http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-631.pdf
03-025IF 03-025IF-634 Linda A. Detwiler [PDF]
Page 1. 03-025IF 03-025IF-634 Linda A. Detwiler Page 2.
Page 3. Page 4. Page 5. Page 6. Page 7. Page 8.
http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-634.pdf
Page 1 of 17 9/13/2005 [PDF]
... 2005 6:17 PM To: fsis.regulationscomments [at] fsis.usda.gov Subject: [Docket
No. 03-025IFA]
FSIS Prohibition of the Use of Specified Risk Materials for Human Food ...
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf
03-025IFA 03-025IFA-6 Jason Frost [PDF]
... Zealand Embassy COMMENTS ON FEDERAL REGISTER 9 CFR Parts 309 et al
[Docket No. 03-
025IF] Prohibition of the Use of Specified Risk Materials for Human Food and
...
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-6.pdf
In its opinion of 7-8 December 2000 (EC 2000), the SSC ... [PDF]
Page 1. Linda A. Detwiler, DVM 225 Hwy 35 Red Bank, New Jersey 07701 Phone:
732-741-2290
Cell: 732-580-9391 Fax: 732-741-7751 June 22, 2005 FSIS Docket Clerk US ...
http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-589.pdf
Volume 12, Number 12–December 2006
PERSPECTIVE
On the Question of Sporadic
or Atypical Bovine SpongiformEncephalopathy and
Creutzfeldt-Jakob Disease
Paul Brown,* Lisa M. McShane,† Gianluigi Zanusso,‡ and Linda Detwiler§
Strategies to investigate the possible existence of sporadic
bovine spongiform encephalopathy (BSE) require
systematic testing programs to identify cases in countries
considered to have little or no risk for orally acquired disease,
or to detect a stable occurrence of atypical cases in
countries in which orally acquired disease is disappearing.
To achieve 95% statistical confidence that the prevalence
of sporadic BSE is no greater than 1 per million (i.e., the
annual incidence of sporadic Creutzfeldt-Jakob disease
[CJD] in humans) would require negative tests in 3 million
randomly selected older cattle. A link between BSE and
sporadic CJD has been suggested on the basis of laboratory
studies but is unsupported by epidemiologic observation.
Such a link might yet be established by the discovery
of a specific molecular marker or of particular combinations
of trends over time of typical and atypical BSE and various
subtypes of sporadic CJD, as their numbers are influenced
by a continuation of current public health measures that
exclude high-risk bovine tissues from the animal and
human food chains.
SNIP...
http://www.cdc.gov/ncidod/EID/vol12no12/06-0965.htm?s_cid=eid06_0965_e
3:00 Afternoon Refreshment Break, Poster and Exhibit Viewing in the Exhibit
Hall
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
Calves were challenged by mouth with homogenised brain from confirmed cases of BSE. Some received 300g (3 doses of 100g), some 100g, 10g or 1g. They were then left to develop BSE, but were not subjected to the normal stresses that they might have encountered in a dairy herd. Animals in all four groups developed BSE. There has been a considerable spread of incubation period in some of the groups, but it appears as if those in the 1 and 10g challenge groups most closely fit the picture of incubation periods seen in the epidemic. Experiments in progress indicate that oral infection can occur in some animals with doses as low as 0.01g and 0.001g. .........
http://www.defra.gov.uk/animalh/bse/science-research/pathog.html#dose
and i think, with time, and testing becomes more and more sensitive, we will all be surprised at just how much is too much, and just how young one might be to spread the agent, even as sub-clinical.
IF i remember correctly, the infamous PURINA FEED MILL incident in Gonzales TEXAS,
where at one feeding, those cows could not have consumed more than......or no more than 5.5 grams...etc. so, how many feedings does a feeder and or dairy calf have in there lifespan ? wouldn't you multiply that by those figures by that ??? be a lot of potential mad cow protein IN COMMERCE, and still is in 2006......tss
FDA has determined that each animal could have consumed, at most and in total, five-and-one-half grams - approximately a quarter ounce -- of prohibited material. These animals weigh approximately 600 pounds.
http://www.fda.gov/bbs/topics/NEWS/2001/NEW00752.html
http://www.fda.gov/ora/about/enf_story/archive/2001/ch5/default.htm
Subject: DOCUMENTATION RELATED TO SPECIFIED RISK MATERIALS (SRMs) AND OTHER REGULATIONS FSIS NOTICE 01-07 1/8/07
Date: January 8, 2007 at 9:28 am PST
FSIS NOTICE 01-07 1/8/07
DOCUMENTATION RELATED TO SPECIFIED RISK MATERIALS (SRMs)
AND OTHER REGULATIONS
This notice clarifies how inspection program personnel are to document regulatory noncompliance related to 9 CFR 310.22 for controlling specified risk materials, as well as other regulations
Inspection program personnel are to cite 9 CFR 310.22 in the Relevant Regulation section of every noncompliance report (NR) for an establishment that does not meet the regulatory requirements for controlling SRMs. In addition to selecting 9 CFR 310.22, inspection program personnel are to select all other regulations with which there has been noncompliance.
For example, while performing the 03C02 procedure, the Inspector-in-Charge (IIC) sees spinal cord material on previously cut T-bone steaks that had passed the Critical Control Point (CCP). The IIC cites 9 CFR 417.2(c)(4) and 310.22(b) in the Relevant Regulations section on the Procedure Results NR screen. The IIC notifies the appropriate establishment official of the finding. The IIC also verifies that the corrective actions implemented by the establishment meet the requirements of 9 CFR 417.3(a) before issuing the NR.
Inspection program personnel are to describe the noncompliances in the Narrative Section, block 10, of the NR. The narrative should include a complete description of the SRM noncompliance, including the type of SRM and any other information relevant to the noncompliance. The narrative should also address each of the other regulations that inspection program personnel cite in the Relevant Regulations section on the NR screen. The statements in block 10 of the NR are to support completely and adequately the regulatory noncompliances cited.
For every NR that inspection program personnel issue, it is important that they cite all relevant regulations. These citations provide data that are the basis for critical, risk-based decisions that the FSIS must regularly make when working to ensure that meat and poultry products are safe. Thus, it is not appropriate for inspection program personnel to cite only one regulation if other regulations are also violated by the noncompliance that is the subject of the NR.
Inspection program personnel with technical questions related to the use of PBIS, or who experience technical problems, should contact the FAIM Help Desk at 1-800-473-9135. They should contact the Technical Service Center at 1-800-233-3935 for policy-related questions.
Philip S. Derfler /s/
Assistant Administrator
Office of Policy, Program, and Employee Development
DISTRIBUTION: Inspection Offices; T/A Inspectors; Plant Mgt; TRA; ABB; TSC; Import Offices NOTICE EXPIRES: 2/1/08 OPI: OPPED
http://www.fsis.usda.gov/regulations_&_policies/Notice_01-07/index.asp
> This notice clarifies how inspection program personnel are to document regulatory noncompliance
> related to 9 CFR 310.22 for controlling specified risk materials, as well as other regulations
SO, it's Monday Jan. 8, 2007, in 2006 ALONE, the FDA allowed literally 100s of 1,000s of TONS of ruminant protein to be fed to not only USA cattle and livestock, but it also exported this poison to other parts of the globe as well, and the FSIS is just NOW clarifying how it's inspectors handle SRMs ??? and no SRMs are being fed to cattle in the USA ???
LIKE i said,
IT'S as obvious as day and night, either Larry, Curley, and Mo have been at the helm of the
USDA/APHIS/FSIS/FDA/CDC/NIH et al for many many years, or the incompetence
of these agencies are so inept, either through ignorance and or just too overweight with industry reps.,
they then should be all done away with and a single agency brought forth, and if not, how will you
correct this ongoing problem ?
http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf
http://www.prwatch.org/node/4624
====================================
2006 (partial list of) highly potential mad cow protein in commerce USA
Subject: MAD COW FEED RECALL USA SEPT 6, 2006 1961.72 TONS IN COMMERCE AL,
TN, AND WV
Date: September 6, 2006 at 7:58 am PST
PRODUCT
a) EVSRC Custom dairy feed, Recall # V-130-6;
b) Performance Chick Starter, Recall # V-131-6;
c) Performance Quail Grower, Recall # V-132-6;
d) Performance Pheasant Finisher, Recall # V-133-6.
CODE
None
RECALLING FIRM/MANUFACTURER
Donaldson & Hasenbein/dba J&R Feed Service, Inc., Cullman, AL, by telephone
on June 23, 2006 and by letter dated July 19, 2006. Firm initiated recall is
complete.
REASON
Dairy and poultry feeds were possibly contaminated with ruminant based
protein.
VOLUME OF PRODUCT IN COMMERCE
477.72 tons
DISTRIBUTION
AL
______________________________
PRODUCT
a) Dairy feed, custom, Recall # V-134-6;
b) Custom Dairy Feed with Monensin, Recall # V-135-6.
CODE
None. Bulk product
RECALLING FIRM/MANUFACTURER
Recalling Firm: Burkmann Feed, Greeneville, TN, by Telephone beginning on
June 28, 2006.
Manufacturer: H. J. Baker & Bro., Inc., Albertville, AL. Firm initiated
recall is complete.
REASON
Possible contamination of dairy feeds with ruminant derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
1,484 tons
DISTRIBUTION
TN and WV
http://www.fda.gov/bbs/topics/enforce/2006/ENF00968.html
Subject: MAD COW FEED RECALLS ENFORCEMENT REPORT FOR AUGUST 9, 2006 KY, LA,
MS, AL, GA, AND TN 11,000+ TONS
Date: August 16, 2006 at 9:19 am PST
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II
______________________________
PRODUCT
Bulk custom made dairy feed, Recall # V-115-6
CODE
None
RECALLING FIRM/MANUFACTURER
Hiseville Feed & Seed Co., Hiseville, KY, by telephone and letter on or
about July 14, 2006. FDA initiated recall is ongoing.
REASON
Custom made feeds contain ingredient called Pro-Lak which may contain
ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
Approximately 2,223 tons
DISTRIBUTION
KY
______________________________
PRODUCT
Bulk custom made dairy feed, Recall # V-116-6
CODE
None
RECALLING FIRM/MANUFACTURER
Rips Farm Center, Tollesboro, KY, by telephone and letter on July 14, 2006.
FDA initiated recall is ongoing.
REASON
Custom made feeds contain ingredient called Pro-Lak which may contain
ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
1,220 tons
DISTRIBUTION
KY
______________________________
PRODUCT
Bulk custom made dairy feed, Recall # V-117-6
CODE
None
RECALLING FIRM/MANUFACTURER
Kentwood Co-op, Kentwood, LA, by telephone on June 27, 2006. FDA initiated
recall is completed.
REASON
Possible contamination of animal feed ingredients, including ingredients
that are used in feed for dairy animals, with ruminant derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
40 tons
DISTRIBUTION
LA and MS
______________________________
PRODUCT
Bulk Dairy Feed, Recall V-118-6
CODE
None
RECALLING FIRM/MANUFACTURER
Cal Maine Foods, Inc., Edwards, MS, by telephone on June 26, 2006. FDA
initiated recall is complete.
REASON
Possible contamination of animal feed ingredients, including ingredients
that are used in feed for dairy animals, with ruminant derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
7,150 tons
DISTRIBUTION
MS
______________________________
PRODUCT
Bulk custom dairy pre-mixes, Recall # V-119-6
CODE
None
RECALLING FIRM/MANUFACTURER
Walthall County Co-op, Tylertown, MS, by telephone on June 26, 2006. Firm
initiated recall is complete.
REASON
Possible contamination of dairy animal feeds with ruminant derived meat and
bone meal.
VOLUME OF PRODUCT IN COMMERCE
87 tons
DISTRIBUTION
MS
______________________________
PRODUCT
Bulk custom dairy pre-mixes, Recall # V-120-6
CODE
None
RECALLING FIRM/MANUFACTURER
Ware Milling Inc., Houston, MS, by telephone on June 23, 2006. Firm
initiated recall is complete.
REASON
Possible contamination of dairy animal feeds with ruminant derived meat and
bone meal.
VOLUME OF PRODUCT IN COMMERCE
350 tons
DISTRIBUTION
AL and MS
______________________________
PRODUCT
a) Tucker Milling, LLC Tm 32% Sinking Fish Grower, #2680-Pellet,
50 lb. bags, Recall # V-121-6;
b) Tucker Milling, LLC #31120, Game Bird Breeder Pellet,
50 lb. bags, Recall # V-122-6;
c) Tucker Milling, LLC #31232 Game Bird Grower,
50 lb. bags, Recall # V-123-6;
d) Tucker Milling, LLC 31227-Crumble, Game Bird Starter, BMD
Medicated, 50 lb bags, Recall # V-124-6;
e) Tucker Milling, LLC #31120, Game Bird Breeder, 50 lb bags,
Recall # V-125-6;
f) Tucker Milling, LLC #30230, 30 % Turkey Starter, 50 lb bags,
Recall # V-126-6;
g) Tucker Milling, LLC #30116, TM Broiler Finisher,
50 lb bags, Recall # V-127-6
CODE
All products manufactured from 02/01/2005 until 06/20/2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tucker Milling LLC, Guntersville, AL, by telephone and visit
on June 20, 2006, and by letter on June 23, 2006.
Manufacturer: H. J. Baker and Brothers Inc., Stamford, CT. Firm initiated
recall is ongoing.
REASON
Poultry and fish feeds which were possibly contaminated with ruminant based
protein were not labeled as "Do not feed to ruminants".
VOLUME OF PRODUCT IN COMMERCE
7,541-50 lb bags
DISTRIBUTION
AL, GA, MS, and TN
END OF ENFORCEMENT REPORT FOR AUGUST 9, 2006
###
http://www.fda.gov/bbs/topics/ENFORCE/2006/ENF00964.html
Subject: MAD COW FEED RECALL MI MAMMALIAN PROTEIN VOLUME OF PRODUCT IN
COMMERCE 27,694,240 lbs
Date: August 6, 2006 at 6:14 pm PST
PRODUCT
Bulk custom dairy feds manufactured from concentrates, Recall # V-113-6
CODE
All dairy feeds produced between 2/1/05 and 6/16/06 and containing H. J.
Baker recalled feed products.
RECALLING FIRM/MANUFACTURER
Vita Plus Corp., Gagetown, MI, by visit beginning on June 21, 2006. Firm
initiated recall is complete.
REASON
The feed was manufactured from materials that may have been contaminated
with mammalian protein.
VOLUME OF PRODUCT IN COMMERCE
27,694,240 lbs
DISTRIBUTION
MI
END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006
###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html
Subject: MAD COW FEED RECALL AL AND FL VOLUME OF PRODUCT IN COMMERCE 125
TONS Products manufactured from 02/01/2005 until 06/06/2006
Date: August 6, 2006 at 6:16 pm PST
PRODUCT
a) CO-OP 32% Sinking Catfish, Recall # V-100-6;
b) Performance Sheep Pell W/Decox/A/N, medicated,
net wt. 50 lbs, Recall # V-101-6;
c) Pro 40% Swine Conc Meal -- 50 lb, Recall # V-102-6;
d) CO-OP 32% Sinking Catfish Food Medicated,
Recall # V-103-6;
e) "Big Jim's" BBB Deer Ration, Big Buck Blend,
Recall # V-104-6;
f) CO-OP 40% Hog Supplement Medicated Pelleted,
Tylosin 100 grams/ton, 50 lb. bag, Recall # V-105-6;
g) Pig Starter Pell II, 18% W/MCDX Medicated 282020,
Carbadox -- 0.0055%, Recall # V-106-6;
h) CO-OP STARTER-GROWER CRUMBLES, Complete
Feed for Chickens from Hatch to 20 Weeks, Medicated,
Bacitracin Methylene Disalicylate, 25 and 50 Lbs,
Recall # V-107-6;
i) CO-OP LAYING PELLETS, Complete Feed for Laying
Chickens, Recall # 108-6;
j) CO-OP LAYING CRUMBLES, Recall # V-109-6;
k) CO-OP QUAIL FLIGHT CONDITIONER MEDICATED,
net wt 50 Lbs, Recall # V-110-6;
l) CO-OP QUAIL STARTER MEDICATED, Net Wt. 50 Lbs,
Recall # V-111-6;
m) CO-OP QUAIL GROWER MEDICATED, 50 Lbs,
Recall # V-112-6
CODE
Product manufactured from 02/01/2005 until 06/06/2006
RECALLING FIRM/MANUFACTURER
Alabama Farmers Cooperative, Inc., Decatur, AL, by telephone, fax, email and
visit on June 9, 2006. FDA initiated recall is complete.
REASON
Animal and fish feeds which were possibly contaminated with ruminant based
protein not labeled as "Do not feed to ruminants".
VOLUME OF PRODUCT IN COMMERCE
125 tons
DISTRIBUTION
AL and FL
END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006
###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html
Subject: MAD COW FEED RECALL KY VOLUME OF PRODUCT IN COMMERCE ?????
Date: August 6, 2006 at 6:19 pm PST
PRODUCT
Bulk custom made dairy feed, Recall # V-114-6
CODE
None
RECALLING FIRM/MANUFACTURER
Burkmann Feeds LLC, Glasgow, KY, by letter on July 14, 2006. Firm initiated
recall is ongoing.
REASON
Custom made feeds contain ingredient called Pro-Lak, which may contain
ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
?????
DISTRIBUTION
KY
END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006
###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html
CJD WATCH MESSAGE BOARD
TSS
MAD COW FEED RECALL USA EQUALS 10,878.06 TONS NATIONWIDE
Sun Jul 16, 2006 09:22
71.248.128.67
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
______________________________
PRODUCT
a) PRO-LAK, bulk weight, Protein Concentrate for Lactating Dairy Animals,
Recall # V-079-6;
b) ProAmino II, FOR PREFRESH AND LACTATING COWS, net weight 50lb (22.6 kg),
Recall # V-080-6;
c) PRO-PAK, MARINE & ANIMAL PROTEIN CONCENTRATE FOR USE IN ANIMAL
FEED, Recall # V-081-6;
d) Feather Meal, Recall # V-082-6
CODE
a) Bulk
b) None
c) Bulk
d) Bulk
RECALLING FIRM/MANUFACTURER
H. J. Baker & Bro., Inc., Albertville, AL, by telephone on June 15, 2006 and
by press release on June 16, 2006. Firm initiated recall is ongoing.
REASON
Possible contamination of animal feeds with ruminent derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
10,878.06 tons
DISTRIBUTION
Nationwide
END OF ENFORCEMENT REPORT FOR July 12, 2006
###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00960.html
Subject: MAD COW FEED BAN WARNING LETTER ISSUED MAY 17, 2006
Date: June 27, 2006 at 7:42 am PST
Public Health Service
Food and Drug Administration
New Orleans District
297 Plus Park Blvd.
Nashville, TN 37217
Telephone: 615-781-5380
Fax: 615-781-5391
May 17, 2006
WARNING LETTER NO. 2006-NOL-06
FEDERAL EXPRESS
OVERNIGHT DELIVERY
Mr. William Shirley, Jr., Owner
Louisiana.DBA Riegel By-Products
2621 State Street
Dallas, Texas 75204
Dear Mr. Shirley:
On February 12, 17, 21, and 22, 2006, a U.S. Food & Drug Administration
(FDA) investigator inspected your rendering plant, located at 509 Fortson
Street, Shreveport, Louisiana. The inspection revealed significant
deviations from the requirements set forth in Title 21, Code of Federal
Regulations, Part 589.2000 [21 CFR 589.2000], Animal Proteins Prohibited in
Ruminant Feed. This regulation is intended to prevent the establishment and
amplification of Bovine Spongiform Encephalopathy (BSE). You failed to
follow the requirements of this regulation; products being manufactured and
distributed by your facility are misbranded within the meaning of Section
403(a)(1) [21 USC 343(a)(1)] of the Federal Food, Drug, and Cosmetic Act
(the Act).
Our investigation found you failed to provide measures, including sufficient
written procedures, to prevent commingling or cross-contamination and to
maintain sufficient written procedures [21 CFR 589.2000(e)] because:
You failed to use clean-out procedures or other means adequate to prevent
carryover of protein derived from mammalian tissues into animal protein or
feeds which may be used for ruminants. For example, your facility uses the
same equipment to process mammalian and poultry tissues. However, you use
only hot water to clean the cookers between processing tissues from each
species. You do not clean the auger, hammer mill, grinder, and spouts after
processing mammalian tissues.
You failed to maintain written procedures specifying the clean-out
procedures or other means to prevent carryover of protein derived from
mammalian tissues into feeds which may be used for ruminants.
As a result . the poultry meal you manufacture may contain protein derived
from mammalian tissues prohibited in ruminant feed. Pursuant to 21 CFR
589.2000(e)(1)(i), any products containing or may contain protein derived
from mammalian tissues must be labeled, "Do not feed to cattle or other
ruminants." Since you failed to label a product which may contain protein
derived from mammalian tissues with the required cautionary statement. the
poultry meal is misbranded under Section 403(a)(1) [21 USC 343(a)(1)] of the
Act.
This letter is not intended as an all-inclusive list of violations at your
facility. As a manufacturer of materials intended for animal feed use, you
are responsible for ensuring your overall operation and the products you
manufacture and distribute are in compliance with the law. You should take
prompt action to correct these violations, and you should establish a system
whereby violations do not recur. Failure to promptly correct these
violations may result in regulatory action, such as seizure and/or
injunction, without further notice.
You should notify this office in writing within 15 working days of receiving
this letter, outlining the specific steps you have taken to bring your firm
into compliance with the law. Your response should include an explanation of
each step taken to correct the violations and prevent their recurrence. If
corrective action cannot be completed within 15 working days, state the
reason for the delay and the date by which the corrections will be
completed. Include copies of any available documentation demonstrating
corrections have been made.
Your reply should be directed to Mark W. Rivero, Compliance Officer, U.S.
Food and Drug Administration, 2424 Edenborn Avenue, Suite 410, Metairie,
Louisiana 70001. If you have questions regarding any issue in this letter,
please contact Mr. Rivero at (504) 219-8818, extension 103.
Sincerely,
/S
Carol S. Sanchez
Acting District Director
New Orleans District
http://www.fda.gov/foi/warning_letters/g5883d.htm
look at the table and you'll see that as little as 1 mg (or 0.001 gm) caused
7% (1 of 14) of the cows to come down with BSE;
Risk of oral infection with bovine spongiform encephalopathy agent in
primates
Corinne Ida Lasmézas, Emmanuel Comoy, Stephen Hawkins, Christian Herzog,
Franck Mouthon, Timm Konold, Frédéric Auvré, Evelyne Correia, Nathalie
Lescoutra-Etchegaray, Nicole Salès, Gerald Wells, Paul Brown, Jean-Philippe
Deslys
Summary The uncertain extent of human exposure to bovine spongiform
encephalopathy (BSE)--which can lead to variant Creutzfeldt-Jakob disease
(vCJD)--is compounded by incomplete knowledge about the efficiency of oral
infection and the magnitude of any bovine-to-human biological barrier to
transmission. We therefore investigated oral transmission of BSE to
non-human primates. We gave two macaques a 5 g oral dose of brain homogenate
from a BSE-infected cow. One macaque developed vCJD-like neurological
disease 60 months after exposure, whereas the other remained free of disease
at 76 months. On the basis of these findings and data from other studies, we
made a preliminary estimate of the food exposure risk for man, which
provides additional assurance that existing public health measures can
prevent transmission of BSE to man.
snip...
BSE bovine brain inoculum
100 g 10 g 5 g 1 g 100 mg 10 mg 1 mg 0·1 mg 0·01 mg
Primate (oral route)* 1/2 (50%)
Cattle (oral route)* 10/10 (100%) 7/9 (78%) 7/10 (70%) 3/15 (20%) 1/15 (7%)
1/15 (7%)
RIII mice (ic ip route)* 17/18 (94%) 15/17 (88%) 1/14 (7%)
PrPres biochemical detection
The comparison is made on the basis of calibration of the bovine inoculum
used in our study with primates against a bovine brain inoculum with a
similar PrPres concentration that was
inoculated into mice and cattle.8 *Data are number of animals
positive/number of animals surviving at the time of clinical onset of
disease in the first positive animal (%). The accuracy of
bioassays is generally judged to be about plus or minus 1 log. ic
ip=intracerebral and intraperitoneal.
Table 1: Comparison of transmission rates in primates and cattle infected
orally with similar BSE brain inocula
Published online January 27, 2005
http://www.thelancet.com/journal/journal.isa
Feb 06, 2004 Washington State Investigation—Final Epidemiology Report
http://www.aphis.usda.gov/newsroom/hot_issues/bse/downloads/WashingtonState_epi_final3-04.pdf
Secretary's Advisory Committee Recommendations
Feb 13, 2004 Secretary’s Advisory Committee Report
http://www.aphis.usda.gov/newsroom/hot_issues/bse/downloads/SAC-Report2-13-04.pdf
Feb 02, 2004 International Review Team (IRT) Report
http://www.aphis.usda.gov/newsroom/hot_issues/bse/downloads/US_BSE_Report2-2-04.pdf
http://www.aphis.usda.gov/newsroom/hot_issues/bse/surveillance/bse_disease_surv.shtml
Information on the Washington State Investigation of the BSE-positive Cow
This Office of Inspector General (OIG)
http://www.usda.gov/oig/webdocs/TestimonyBlurb2.pdf
http://www.usda.gov/oig/webdocs/Testimony7-2004.pdf
http://www.usda.gov/oig/webdocs/50601-9-final.pdf
OIG REPORT ON IMPORTS FROM CANADA
http://www.usda.gov/oig/webdocs/33601-01-HY.pdf
Final Case Summeries
May 02, 2006 Alabama BSE Investigation—Final Epidemiology Report
http://www.aphis.usda.gov/newsroom/hot_issues/bse/downloads/EPI_Final5-2-06.pdf
http://www.scienceblog.com/cms/feds_confirm_mad_cow_in_alabama_10204.html
http://www.prwatch.org/node/4624
http://www.microbes.info/forums/index.php?showtopic=306
Aug 30, 2005 USDA Texas BSE Investigation—Final Epidemiology Report
http://www.aphis.usda.gov/newsroom/hot_issues/bse/downloads/bse_final_epi_report8-05.pdf
TSS REPORT ON 2ND TEJAS MAD COW Mon, 22 Nov 2004 17:12:15 -0600 (the one
that did NOT get away, thanks to the Honorable Phyllis Fong)
-------- Original Message --------
Subject: Re: BSE 'INCONCLUSIVE' COW from
TEXAS ???
Date: Mon, 22 Nov 2004 17:12:15 -0600
From: "Terry S. Singeltary Sr."
To: Carla Everett
References: <[log in to unmask]>
<[log in to unmask] us>
Greetings Carla,still hear a rumor;
Texas single beef cow not born in Canada no beef entered the food chain?
and i see the TEXAS department of animal health is ramping up forsomething,
but they forgot a url for update?I HAVE NO ACTUAL CONFIRMATION YET...can you
confirm???terry
==============================
==============================
-------- Original Message --------
Subject: Re: BSE 'INCONCLUSIVE' COW from
TEXAS ???
Date: Fri, 19 Nov 2004 11:38:21 -0600
From: Carla Everett
To: "Terry S. Singeltary Sr."
References: <[log in to unmask]>
The USDA has made a statement, and we are referring all callers to the USDA
web site. We have no informationabout the animal being in Texas. CarlaAt
09:44 AM 11/19/2004, you wrote:>Greetings Carla,>>i am getting
unsubstantiated claims of this BSE 'inconclusive' cow is from>TEXAS. can you
comment on this either way please?>>thank you,>Terry S. Singeltary Sr.>>
===================
===================
-------- Original Message --------
Subject: Re: BSE 'INCONCLUSIVE' COW from
TEXAS ???
Date: Mon, 22 Nov 2004 18:33:20 -0600
From: Carla Everett
To: "Terry S. Singeltary Sr."
References: <[log in to unmask]>
<[log in to unmask] us>
<[log in to unmask]> <[log in to unmask]
us> <[log in to unmask]>
our computer department was working on a place holder we could post USDA's
announcement of any results. There are no results to be announced tonight by
NVSL, so we are back in a waiting mode and will post the USDA
announcementwhen we hear something.At 06:05 PM 11/22/2004, you wrote:>why
was the announcement on your TAHC site removed?>>Bovine Spongiform
Encephalopathy:>November 22: Press Release title here >>star image More BSE
information>>>>terry>>Carla Everett wrote:>>>no confirmation on the U.S.'
inconclusive test...>>no confirmation on location of
animal.>>>>>>
==========================
==========================
THEN, 7+ MONTHS OF COVER-UP BY JOHANN ET AL! no doubt about it now $$$
NO, it's not pretty, hell, im not pretty, but these are the facts, take em
or leave em, however, you cannot change them.
with kindest regards,
I am still sincerely disgusted and tired in sunny Bacliff, Texas USA 77518
Terry S. Singeltary Sr.
FULL 130 LASHINGS TO USDA BY OIG again
http://www.usda.gov/oig/webdocs/50601-10-KC.pdf
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0612&L=sanet-mg&T=0&P=23557
Feb 06, 2004 Washington State Investigation—Final Epidemiology Report
http://www.aphis.usda.gov/newsroom/hot_issues/bse/downloads/WashingtonState_epi_final3-04.pdf
Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION]
http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-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/03/Jan03/012403/8004be07.html
PART 2
http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be09.html
ALSO, now with the 4th documented transmission of vCJD via transfusion, from such a small donor pool, we must ban blood from feed for animal and human consumption ;
Fourth case of transfusion-associated vCJD infection in the United Kingdom
Editorial team (eurosurveillance.weekly [at] hpa.org.uk), Eurosurveillance
editorial office
A suspected 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/PressReleasesN
otices/fs/en?CONTENT_ID=4076608&chk=MTwE%2Bl)
http://www.eurosurveillance.org/ew/2007/070118.asp#4
THE last time a country decided it was o.k. to poison the rest of the world, I thought we had learned something from it, I suppose we have not. that is all in the world the BSE MRR policy is, a legal tool to poison the globe, just for commodities and futures. THIS time however, we are dealing with a more virulent strain of mad cow disease i.e. BASE, and it's been here in the USA for some time if you go back and look at the studies of Mission, Texas from the Scrapie transmission studies there. So I failed to see the logic of this BSE MRR policy, there is nothing science based about it. ...
CONFIDENTIAL BSE POLICY
http://www.bseinquiry.gov.uk/files/yb/1994/05/20002001.pdf
RESTRICTED
MINISTER'S MEETING ON BSE (EXPORTS AND TRIPE) AND ANTHRAX, 14, JULY 1989
http://www.bseinquiry.gov.uk/files/yb/1989/07/14006001.pdf
England worried briefly about infecting other countries
27 Aug 00 confidential correspondence obtained by Terry S. Singeltary Sr.
BSE11/2 020;
SC1337p
DEPARTMENT OF HEALTH AND SOCIAL SECURITY
Richmond House, 79 Whitehall, London SWIA 2NS
Telephone 01-210 3000
From the Chief Medical Officer
Sir Donald Achson KBE DM DSc FRCP FFCM FFOM
Mr K C Meldrum
Chief Veterinary Officer
Ministry of Agriculture, Fisheries and Food
Government Buildings
Hook Rise South
Tolworth
Surbiton
Surrey
KT6 7NG 3 January 1990
Dear Mr Meldrum
BOVINE SPONGIFORM ENCEPHALOPATHY
You will recall that we have previously discussed the potential risks of
BSE occurring in other countries as a result of the continuing export
from the UK of meat and bone that may be contaminated by scrapie or
possibly BSE.
I remain concerned that we are not being consistent in our attempts to
contain the risks of BSE. Having banned the feeding of meat and bone
meal to ruminamts in 1988, we should take steps to prevent these UK
products being fed to ruminants in other countries. This could be
achieved either through a ban on the export of meat and bone meal,
or at least by the proper labelling of these products to make it
absolutely clear they should not be fed to ruminants
[or zoo animals, including rare and endangered primates -- webmaster].
Unless some such action is taken the difficult problems we have faced with BSE
may well occur in other countries who import UK meat and bone meal.
Surely it is short sighted for us to risk being seen in future as
having been responsible for the introduction of BSE to the food chain
in other countries.
I would be very interested to hear how you feel this gap in the present
precautionary measures to eliminate BSE should be closed. We should be
aiming at the global elimination of this new bovine disense. The export
of our meat and bone meal is a continuing risk to other countries.
Yours Sincerely
Donald Acheson
Copy:
Dr Metters
Dr Pickles
90/1.03/1.1
============
BSE13/3 0083
Dr Pickles
From: Dr J S Metters DCM0
International, Prevention and Community Services
7 June 1990
Copies to: Dr McInnes Miss Pease Mr Otley
BSE
1. I spoke to Mr Capstick yesterday. Among other things, he told me
that MAFF are now considering the labelling of animal foodstuffs, and
in particular what detail would be required if such labelling was made
compulsory. Apparently our freedom of action is constrained by EC
Directives [total garbage, MAFF wants to keep exporting -- webmaster], and there is also concern about the level of detail that
should be included in any foodstuff labels.
2. Mr Capstick suggested that this was not an area that DH had a
particular interest. I countered by saying that we supported the
principle of labelling of animal foodstuffs, particularly when these
were going for export.
3. I also thanked him for keeping us informed, in a way that I hope
encourage further communication of MAFF's internal deliberations.
J S METTERS
Room 509
Richmond House
Ext. 5591 92/YdeS 90/6.7/5.1
http://www.mad-cow.org/00/aug00_last_news.html#fff
http://www.bseinquiry.gov.uk/files/yb/1990/01/03001001.pdf
> Transmission Studies
>
> Mule deer transmissions of CWD were by intracerebral inoculation and
> compared with natural cases
>
> {the following was written but with a single line marked through it
''first
> passage (by this route)}...TSS
>
> resulted in a more rapidly progressive clinical disease with repeated
> episodes of synocopy ending in coma. One control animal became affected,
it
> is believed through contamination of inoculum (?saline). Further CWD
> transmissions were carried out by Dick Marsh into ferret, mink and
squirrel
> monkey. Transmission occurred in ALL of these species with the shortest
> incubation period in the ferret.
>
> snip...
>
> Appendix 3
>
> VISIT TO USA - DR A E WRATHALL - INFO OH BSE AND SCRAPIE
>
> 1. Dr Clark lately of the Scrapie Research Unit, Mission Texas has
> successfully transmitted ovine and caprine scrapie to cattle. The
> experimental results have not been published but there are plans to do
> this. This work was initiated in 1978. A summary of it is:-
>
> Expt A
> 6 Her x Jer calves born in 1978 were inoculated as follows with
> a 2nd Suffolk scrapie passage:-
>
>
> i/c 1ml; i/m, 5ml; s/c 5ml; oral 30ml.
> 1/6 went down after 48 months with a scrapie/BSE-like disease.
>
> Expt B
> 6 Her or Jer or HxJ calves were inoculated with angora Goat
> virus 2/6 went down similarly after 36 months.
>
> Expt C
> Mice inoculated from brains of calves/cattle in expts A • B
> were resistant, only 1/20 going down with scrapie and this was the
> reason given for not publishing.
>
> Diagnosis in A, B, C was by histopath. No reports on SAT were given.
>
> 2. Dr Warren Foote indicated success so far in eliminating scrapie in
> offspring from experimentally- (and naturally) infected sheep by ET.
> He had found difficulty in obtaining embryos from naturally infected
> sheep (cf SPA).
>
> 3. Prof. A Robertson gave a brief account of BSE. The US approach was to
> accord it a very low profile indeed. Dr A Thiermann showed the
> picture in the "Independent" with cattle being incinerated and thought
> this was a fanatical incident to be avoided in the US at all costs.
> BSE was not reported in USA.
>
>
> 4. Scrapie incidents (ie affected flocks) have shown a dramatic increase
> since 1978. In 1953 when the National Control Scheme was started
> there were 10-14 incidents, in 1978 - 1 and in 1988 so far 60.
>
> 5. Scrapie agent was reported to have been isolated from a solitary
> fetus.
>
> 6. A western blotting diagnostic technique (? on PrP) shows some promise.
>
> 7. Results of a questionnaire sent to 33 states on the subject of the
> national sheep scrapie programme survey indicated
>
>
> 17/33 wished to drop it
>
> 6/33 wished to develop it
>
> 8/33 had few sheep and were neutral
>
>
> Information obtained from Dr Wrathall's notes of a meeting of the U.S.
> Animal Health Association at Little Rock, Arkansas Nov. 1988.
>
>
>
> 33
>
> end...TSS
>
>
> >> Differences in tissue distribution could require new regulations
> >> regarding specific risk material (SRM) removal.
>
>
> snip...end
>
> full text 33 PAGES ;
>
>
> http://www.bseinquiry.gov.uk/files/mb/m11b/tab01.pdf
>
> http://www.bseinquiry.gov.uk/files/yb/1988/10/00001001.pdf
>
>
> It was, however, performed in the USA in 1979, when it was shown that
cattle
> inoculated with the scrapie agent endemic in the flock of Suffolk sheep at
> the United States Department of Agriculture in Mission, Texas, developed a
> TSE quite unlike BSE. 32 The findings of the initial transmission, though
> not of the clinical or neurohistological examination, were communicated in
> October 1988 to Dr Watson, Director of the CVL, following a visit by Dr
> Wrathall, one of the project leaders in the Pathology Department of the
CVL,
> to the United States Department of Agriculture. 33 The results were not
> published at this point, since the attempted transmission to mice from the
> experimental cow brain had been inconclusive. The results of the clinical
> and histological differences between scrapie-affected sheep and cattle
were
> published in 1995. Similar studies in which cattle were inoculated
> intracerebrally with scrapie inocula derived from a number of
> scrapie-affected sheep of different breeds and from different States, were
> carried out at the US National Animal Disease Centre. 34 The results,
> published in 1994, showed that this source of scrapie agent, though
> pathogenic for cattle, did not produce the same clinical signs of brain
> lesions characteristic of BSE.
>
> http://www.bseinquiry.gov.uk/
>
>
>
> 1: J Infect Dis. 1994 Apr;169(4):814-20.
>
>
> Intracerebral transmission of scrapie to cattle.
>
> Cutlip RC, Miller JM, Race RE, Jenny AL, Katz JB, Lehmkuhl HD, DeBey BM,
> Robinson MM.
>
> USDA, Agriculture Research Service, National Animal Disease Center, Ames,
IA
> 50010.
>
> To determine if sheep scrapie agent(s) in the United States would induce a
> disease in cattle resembling bovine spongiform encephalopathy, 18 newborn
> calves were inoculated intracerebrally with a pooled suspension of brain
> from 9 sheep with scrapie. Half of the calves were euthanatized 1 year
after
> inoculation. All calves kept longer than 1 year became severely lethargic
> and demonstrated clinical signs of motor neuron dysfunction that were
> manifest as progressive stiffness, posterior pares
For more information:
http://www.fsis.usda.gov/OPPDE/Comments/20...
> 1: J Infect Dis. 1994 Apr;169(4):814-20.
>
>
> Intracerebral transmission of scrapie to cattle.
>
> Cutlip RC, Miller JM, Race RE, Jenny AL, Katz JB, Lehmkuhl HD, DeBey BM,
> Robinson MM.
>
> USDA, Agriculture Research Service, National Animal Disease Center, Ames,
IA
> 50010.
>
> To determine if sheep scrapie agent(s) in the United States would induce a
> disease in cattle resembling bovine spongiform encephalopathy, 18 newborn
> calves were inoculated intracerebrally with a pooled suspension of brain
> from 9 sheep with scrapie. Half of the calves were euthanatized 1 year
after
> inoculation. All calves kept longer than 1 year became severely lethargic
> and demonstrated clinical signs of motor neuron dysfunction that were
> manifest as progressive stiffness, posterior paresis, general weakness,
and
> permanent recumbency. The incubation period was 14-18 months, and the
> clinical course was 1-5 months. The brain from each calf was examined for
> lesions and for protease-resistant prion protein. Lesions were subtle, but
a
> disease-specific isoform of the prion protein was present in the brain of
> all calves. Neither signs nor lesions were characteristic of those for
> bovine spongiform encephalopathy.
>
> MeSH Terms:
> Animals
> Brain/microbiology*
> Brain/pathology
> Cattle
> Cattle Diseases/etiology*
> Cattle Diseases/pathology
> Encephalopathy, Bovine Spongiform/etiology*
> Encephalopathy, Bovine Spongiform/pathology
> Immunoblotting/veterinary
> Immunohistochemistry
> Male
> Motor Neurons/physiology
> Prions/analysis
> Scrapie/pathology
> Scrapie/transmission*
> Sheep
> Sleep Stages
> Time Factors
>
> Substances:
> Prions
>
>
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8133096&dopt=Citation
>
>
> Intracerebral transmission of scrapie to cattle FULL TEXT PDF;
>
> SNIP...
>
>
> Discussion
>
>
> WE conclude that American sources of sheep scrapie are transmissible to
> cattle by direct intracerebral inoculation but the disease induced is NOT
> identical to BSE as seen in the United Kingdom. While there were
> similarities in clinical signs between this experimental disease and BSE,
> there was no evidence of aggressiveness, hyperexcitability, hyperesthesia
> (tactile or auditory), or hyperemetria of limbs as has been reported for
BSE
> (9). Neither were there extensive neurologic lesions, which are primary
for
> BSE, such as severe vacuolation of neurons and neuropil or neuronal
necrosis
> and gliosis. Although some vacuolation of neuropil, chromotolysis in
> neurons, and gliosis were seen in the brains of some affected calves,
these
> were industinguishable from those of controls. Vacuolated neurons in the
red
> nucleus of both challenged and normal calves were considered normal for
the
> bovines as previously described (50).
>
>
> PrP-res was found in ALL CHALLENGED CALVES REGARDLESS OF CLINCIAL SIGNS,
and
> the amount of PrP-res positively related to the length of the incubation.
> ...
>
>
> snip...
>
>
> WE also conclude from these studies that scrapie in cattle MIGHT NOT BE
> RECOGNIZED BY ROUTINE HISTOPATHOLOGICAL EXAMINATION OF THE BRAIN AND
SUGGEST
> THAT DETECTION OF PrP-res by immunohistochemistry or immunoblotting is
> necessary to make a definitive diagnosis. THUS, undiagnosed scrapie
> infection could contribute to the ''DOWNER-COW'' syndrome and could be
> responsible for some outbreaks of transmissible mink encephalopathy
proposed
> by Burger and Hartsough (8) and Marsh and harsough (52). ...
>
>
> snip...
>
>
> Multiple sources of sheep affected with scrapie and two breeds of cattle
> from several sources were used inthe current study in an effort to avoid a
> single strain of either agent or host. Preliminary results from mouse
> inoculations indicate multiple strains of the agent were present in the
> pooled inoculum (unpublished data). ...
>
>
> Transmission of the sheep scrapie to cattle was attempted in 1979 by using
> intracerebral, intramuscular, subcutaneous, and oral routes of inoculation
> of 5, 8- to 11-month old cattlw with a homologous mixture of brain from 1
> affected sheep (61, 62). ONE of the 5 cattle develped neurologic signs 48
> months after inoculation. Signs were disorientation, incoordination, a
> stiff-legged stilted gait, progressive difficulty in rising, and finally
in
> terminal recumbency. The clinical course was 2.5 months. TWO of the 5
cattle
> similarly inoculated with brain tissue from a goat with scrapie exhibited
> similar signs 27 and 36 months after incoluation. Clinical courses were 43
> an 44 days. Brain lesions of mild gliosis and vacuolation and mouse
> inoculation data were insufficient to confirm a diagnosis of scrapie. This
> work remained controversial until recent examination of the brains
detected
> PrP-res in all 3 cattle with neurologic disease but in none of the
> unaffected cattle (62). Results of these studies are similar to ours and
> underscore the necessity of methods other than histopathology to diagnose
> scrapie infection in cattle. We believe that immunologic techniques for
> detecting PrP-res currently provide the most sensitive and reliable way to
> make a definitive diagnosis...
>
>
> http://www.bseinquiry.gov.uk/files/sc/seac17/tab03.pdf
>
>
> Visit to USA ... info on BSE and Scrapie
>
> http://www.bseinquiry.gov.uk/files/yb/1988/10/00001001.pdf
>
snip...
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0610&L=sanet-mg&D=0&T=0&P=19406
2006-2007 USA AND OIE POISONING GLOBE WITH BSE MRR POLICY
***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
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. A study also demonstrated that in a
mouse model it was possible to alleviate the pathological changes of prion
disease by suppressing expression of the prion protein gene after infection.
http://www.seac.gov.uk/minutes/95.pdf
THE USA is in a most unique situation, one of unknown circumstances with human and animal TSE. THE USA has the most documented TSE in different species to date, with substrains growing in those species (BSE/BASE in cattle and CWD in deer and elk, there is evidence here with different strains), and we know that sheep scrapie has over 20 strains of the typical scrapie with atypical scrapie documented and also BSE is very likely to have passed to sheep. all of which have been
rendered and fed back to animals for human and animal consumption, a frightening scenario. WE do not know the outcome, and to play with human life around the globe with the very likely TSE tainted products from the USA, in my opinion is like playing Russian roulette, of long duration, with potential long and enduring consequences, of which once done, cannot be undone. These are the facts as I have come to know through daily and extensive research of TSE over 9 years, since 12/14/97.
I do not pretend to have all the answers, but i do know to continue to believe in the ukbsenvcjd only theory of transmission to humans of only this one strain from only this one TSE from only this one part of the globe, will only lead to further failures, and needless exposure to humans from all strains of TSE, and possibly many
more needless deaths from TSE via a multitude of proven routes and sources via many studies with primates and rodents and other species.
MY personal belief, since you ask, is that not only the Canadian border, but the USA border, and the Mexican border should be sealed up tighter than a drum for exporting there TSE tainted products, until a validated, 100% sensitive test is available, and all animals for human and animal consumption are tested. all we are doing is the exact same thing the UK did with there mad cow poisoning when they exported it all over the globe, all the while knowing what they were doing. this BSE MRR policy is nothing more than a legal tool to do just exactly what the UK did, thanks to the OIE and GW, it's legal now. and they executed Saddam for poisoning ???
go figure. ...
Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518
Comment Submitted
Comment Receipt
Thank you. Your comment on Document ID: APHIS-2006-0041-0001 has been sent. Comment Tracking Number: XXXXXXXXXXXXXXXXXX
Attachments:
XXXXXXXXXXXXAPHIS-2006-0041_January 28.doc
If you wish to retain a copy of the receipt, use the following link to print a copy for your files. Print
http://www.regulations.gov/fdmspublic/component/main
TSS
>
>
> Intracerebral transmission of scrapie to cattle.
>
> Cutlip RC, Miller JM, Race RE, Jenny AL, Katz JB, Lehmkuhl HD, DeBey BM,
> Robinson MM.
>
> USDA, Agriculture Research Service, National Animal Disease Center, Ames,
IA
> 50010.
>
> To determine if sheep scrapie agent(s) in the United States would induce a
> disease in cattle resembling bovine spongiform encephalopathy, 18 newborn
> calves were inoculated intracerebrally with a pooled suspension of brain
> from 9 sheep with scrapie. Half of the calves were euthanatized 1 year
after
> inoculation. All calves kept longer than 1 year became severely lethargic
> and demonstrated clinical signs of motor neuron dysfunction that were
> manifest as progressive stiffness, posterior paresis, general weakness,
and
> permanent recumbency. The incubation period was 14-18 months, and the
> clinical course was 1-5 months. The brain from each calf was examined for
> lesions and for protease-resistant prion protein. Lesions were subtle, but
a
> disease-specific isoform of the prion protein was present in the brain of
> all calves. Neither signs nor lesions were characteristic of those for
> bovine spongiform encephalopathy.
>
> MeSH Terms:
> Animals
> Brain/microbiology*
> Brain/pathology
> Cattle
> Cattle Diseases/etiology*
> Cattle Diseases/pathology
> Encephalopathy, Bovine Spongiform/etiology*
> Encephalopathy, Bovine Spongiform/pathology
> Immunoblotting/veterinary
> Immunohistochemistry
> Male
> Motor Neurons/physiology
> Prions/analysis
> Scrapie/pathology
> Scrapie/transmission*
> Sheep
> Sleep Stages
> Time Factors
>
> Substances:
> Prions
>
>
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8133096&dopt=Citation
>
>
> Intracerebral transmission of scrapie to cattle FULL TEXT PDF;
>
> SNIP...
>
>
> Discussion
>
>
> WE conclude that American sources of sheep scrapie are transmissible to
> cattle by direct intracerebral inoculation but the disease induced is NOT
> identical to BSE as seen in the United Kingdom. While there were
> similarities in clinical signs between this experimental disease and BSE,
> there was no evidence of aggressiveness, hyperexcitability, hyperesthesia
> (tactile or auditory), or hyperemetria of limbs as has been reported for
BSE
> (9). Neither were there extensive neurologic lesions, which are primary
for
> BSE, such as severe vacuolation of neurons and neuropil or neuronal
necrosis
> and gliosis. Although some vacuolation of neuropil, chromotolysis in
> neurons, and gliosis were seen in the brains of some affected calves,
these
> were industinguishable from those of controls. Vacuolated neurons in the
red
> nucleus of both challenged and normal calves were considered normal for
the
> bovines as previously described (50).
>
>
> PrP-res was found in ALL CHALLENGED CALVES REGARDLESS OF CLINCIAL SIGNS,
and
> the amount of PrP-res positively related to the length of the incubation.
> ...
>
>
> snip...
>
>
> WE also conclude from these studies that scrapie in cattle MIGHT NOT BE
> RECOGNIZED BY ROUTINE HISTOPATHOLOGICAL EXAMINATION OF THE BRAIN AND
SUGGEST
> THAT DETECTION OF PrP-res by immunohistochemistry or immunoblotting is
> necessary to make a definitive diagnosis. THUS, undiagnosed scrapie
> infection could contribute to the ''DOWNER-COW'' syndrome and could be
> responsible for some outbreaks of transmissible mink encephalopathy
proposed
> by Burger and Hartsough (8) and Marsh and harsough (52). ...
>
>
> snip...
>
>
> Multiple sources of sheep affected with scrapie and two breeds of cattle
> from several sources were used inthe current study in an effort to avoid a
> single strain of either agent or host. Preliminary results from mouse
> inoculations indicate multiple strains of the agent were present in the
> pooled inoculum (unpublished data). ...
>
>
> Transmission of the sheep scrapie to cattle was attempted in 1979 by using
> intracerebral, intramuscular, subcutaneous, and oral routes of inoculation
> of 5, 8- to 11-month old cattlw with a homologous mixture of brain from 1
> affected sheep (61, 62). ONE of the 5 cattle develped neurologic signs 48
> months after inoculation. Signs were disorientation, incoordination, a
> stiff-legged stilted gait, progressive difficulty in rising, and finally
in
> terminal recumbency. The clinical course was 2.5 months. TWO of the 5
cattle
> similarly inoculated with brain tissue from a goat with scrapie exhibited
> similar signs 27 and 36 months after incoluation. Clinical courses were 43
> an 44 days. Brain lesions of mild gliosis and vacuolation and mouse
> inoculation data were insufficient to confirm a diagnosis of scrapie. This
> work remained controversial until recent examination of the brains
detected
> PrP-res in all 3 cattle with neurologic disease but in none of the
> unaffected cattle (62). Results of these studies are similar to ours and
> underscore the necessity of methods other than histopathology to diagnose
> scrapie infection in cattle. We believe that immunologic techniques for
> detecting PrP-res currently provide the most sensitive and reliable way to
> make a definitive diagnosis...
>
>
> http://www.bseinquiry.gov.uk/files/sc/seac17/tab03.pdf
>
>
> Visit to USA ... info on BSE and Scrapie
>
> http://www.bseinquiry.gov.uk/files/yb/1988/10/00001001.pdf
>
snip...
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0610&L=sanet-mg&D=0&T=0&P=19406
2006-2007 USA AND OIE POISONING GLOBE WITH BSE MRR POLICY
***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
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. A study also demonstrated that in a
mouse model it was possible to alleviate the pathological changes of prion
disease by suppressing expression of the prion protein gene after infection.
http://www.seac.gov.uk/minutes/95.pdf
THE USA is in a most unique situation, one of unknown circumstances with human and animal TSE. THE USA has the most documented TSE in different species to date, with substrains growing in those species (BSE/BASE in cattle and CWD in deer and elk, there is evidence here with different strains), and we know that sheep scrapie has over 20 strains of the typical scrapie with atypical scrapie documented and also BSE is very likely to have passed to sheep. all of which have been
rendered and fed back to animals for human and animal consumption, a frightening scenario. WE do not know the outcome, and to play with human life around the globe with the very likely TSE tainted products from the USA, in my opinion is like playing Russian roulette, of long duration, with potential long and enduring consequences, of which once done, cannot be undone. These are the facts as I have come to know through daily and extensive research of TSE over 9 years, since 12/14/97.
I do not pretend to have all the answers, but i do know to continue to believe in the ukbsenvcjd only theory of transmission to humans of only this one strain from only this one TSE from only this one part of the globe, will only lead to further failures, and needless exposure to humans from all strains of TSE, and possibly many
more needless deaths from TSE via a multitude of proven routes and sources via many studies with primates and rodents and other species.
MY personal belief, since you ask, is that not only the Canadian border, but the USA border, and the Mexican border should be sealed up tighter than a drum for exporting there TSE tainted products, until a validated, 100% sensitive test is available, and all animals for human and animal consumption are tested. all we are doing is the exact same thing the UK did with there mad cow poisoning when they exported it all over the globe, all the while knowing what they were doing. this BSE MRR policy is nothing more than a legal tool to do just exactly what the UK did, thanks to the OIE and GW, it's legal now. and they executed Saddam for poisoning ???
go figure. ...
Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518
Comment Submitted
Comment Receipt
Thank you. Your comment on Document ID: APHIS-2006-0041-0001 has been sent. Comment Tracking Number: XXXXXXXXXXXXXXXXXX
Attachments:
XXXXXXXXXXXXAPHIS-2006-0041_January 28.doc
If you wish to retain a copy of the receipt, use the following link to print a copy for your files. Print
http://www.regulations.gov/fdmspublic/component/main
TSS
For more information:
http://www.fsis.usda.gov/OPPDE/Comments/20...
Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants; Proposed Rule Docket No. 2005N-0373 RIN # 0910-AF54
COMMENT SUBMISSION TO ;
Docket No. 2005N-0373
and RIN number 0910-AF54
[Federal Register: January 12, 2007 (Volume 72, Number 8)]
[Proposed Rules]
[Page 1581-1619]
Docket No. 2005N-0373
and RIN number 0910-AF54
Use of Materials Derived from Cattle in Medical Products Intended for
Use in Humans and Drugs Intended for Use in Ruminants; Proposed Rule
snip...
SUMMARY: The Food and Drug Administration (FDA) is proposing to
prohibit the use of certain cattle material in, or in the manufacture
(including processing) of, drugs, biologics, and medical devices
intended for use in humans and human cells, tissues, and cellular and
tissue-based products (HCT/Ps) (collectively, medical products for
humans), and in drugs intended for use in ruminant animals (drugs for
ruminants). FDA is also proposing new recordkeeping requirements for
medical products for humans and drugs for ruminants that are
manufactured from or otherwise contain material from cattle. FDA is
proposing these actions as part of its continuing efforts to strengthen
defenses against the potential risk of exposure to, and spread of,
bovine spongiform encephalopathy (BSE) and related human disease in the
United States.
DATES: Submit written or electronic comments on the proposed rule by
March 13, 2007. Submit written comments on the information collection
requirements by February 12, 2007. Requests for an informal hearing on
the proposed ban related to medical devices must be submitted by
February 12, 2007.
ADDRESSES: You may submit comments, identified by Docket No. 2005N-0373
and RIN number 0910-AF54, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following ways:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Agency Web site: http://www.fda.gov/dockets/ecomments.
snip...end
http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/E6-22329.htm
TSS SUBMISSION TO ;
Docket No. 2005N-0373
and RIN number 0910-AF54
Greetings FDA et al,
ONCE again I would kindly like to comment on the continuous failed attempts
by the FDA to regulate the use of certain cattle material in, or in the manufacture
including processing) of, drugs, biologics, and medical devices
intended for use in humans and human cells, tissues, and cellular and
tissue-based products (HCT/Ps) (collectively, medical products for
humans), and in drugs intended for use in ruminant animals (drugs for
ruminants) from the proven risk factors of Transmissible Spongiform Encephalopahy
i.e. TSE's in all species. I have continued to warn the FDA et al about these
risk factors via the surgical and medical arena (vaccines, nutritional supplements,
bovine heart valves, and other animal donor tissue), and I have continued to point
out the risk factor of the UKBSENVCJD only theory, and the ramifications there from,
i.e. BASE (bovine amyloidotic spongiform encephalopathy), and my greatest fears, one
I have warned you about time and time again, seems to be coming true ;
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. A study also demonstrated that in a
mouse model it was possible to alleviate the pathological changes of prion
disease by suppressing expression of the prion protein gene after infection.
http://www.seac.gov.uk/minutes/95.pdf
3:00 Afternoon Refreshment Break, Poster and Exhibit Viewing in the Exhibit
Hall
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
Volume 12, Number 12–December 2006
PERSPECTIVE
On the Question of Sporadic or Atypical Bovine Spongiform Encephalopathy and
Creutzfeldt-Jakob Disease
http://www.cdc.gov/ncidod/EID/vol12no12/06-0965.htm?s_cid=eid06_0965_e
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
Disturbingly, we now know that the USA has had, beyond any shadow of a doubt, been
circulating TSE in a very wide variety of products, and have been for decades. Even
more disturbingly, we now have to deal with, whether or not the industry like it or not,
atypical TSE i.e. BASE in the USA. NOW we have the 4th documented vCJD transfusion related
case in the U.K., this raises serious questions about blood and tissue related products in
relations to TSE transmission from all species ;
Date: January 18, 2007 at 8:32 am PST
Fourth case of transfusion-associated vCJD infection in the United Kingdom
Editorial team (eurosurveillance.weekly [at] hpa.org.uk), Eurosurveillance editorial office
A suspected 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:
snip...
http://www.eurosurveillance.org/ew/2007/070118.asp#4
SEE ALSO ;
HPA Press Statement
18 January 2007
4th case of variant CJD infection associated with blood transfusion
http://www.hpa.org.uk/hpa/news/articles/press_releases/2007/070118_vCJD.htm
ONCE again I must warn you that the USA is in a most unique situation, one of unknown
circumstances with human and animal TSE. THE USA has the most documented TSE in different
species to date, with substrains growing in those species (BSE/BASE in cattle and CWD in
deer and elk, there is evidence here with different strains), and we know that sheep scrapie
has over 20 strains of the typical scrapie with atypical scrapie documented and also BSE is
very likely to have passed to sheep. all of which have been rendered and fed back to animals
for human and animal consumption, a frightening scenario. WE do not know the outcome, and to
play with human life around the globe with the very likely TSE tainted blood and tissue from
the USA bovine, in my opinion is like playing Russian roulette, of long duration, with potential
long and enduring consequences, of which once done, cannot be undone. These are the facts as I
have come to know through daily and extensive research of TSE over 9 years, since 12/14/97. I tried
to warn back in 2001, at the infamous Jan. 9, 2001 50 STATE BSE CONFERENCE CALL that the USA indeed
was still feeding ruminant protein to 'tissue and blood donor herds', to no avail.
I do not pretend to have all the answers, but I do know to continue to believe in the ukbsenvcjd only
theory of transmission to humans of only this one strain from only this one TSE from only this one
part of the globe, will only lead to further failures, and needless exposure to humans from all strains
of TSE, and possibly many more needless deaths from TSE via a multitude of proven routes and sources via
many studies with primates and rodents and other species. ...
WE have known about risk factors of Scrapie Associated Fibers i.e. SAFs and ignored
the '1968 MEDICINE ACT' ;
http://www.bseinquiry.gov.uk/files/yb/1989/01/30008001.pdf
http://www.bseinquiry.gov.uk/files/ws/s469.pdf
The BSE Inquiry / Statement No 477
Professor Sir James Armour
Issued 07/07/1999
snip...
Summary
Although the letter from the BSE Inquiry requesting evidence was addressed to me, I have
presented the course of events as handled by the VPC under my chairmanship. There was very
good agreement between the Committee and myself on the advice given to the Medicines Unit,
VMD and the Licensing Authority. Advice given through 1988 and 1989 centred on the
development of Guidelines, both UK and European, in relation to the source and tissues of origin
of materials used in the manufacture of veterinary products (and their sterilisation).
Answers to Specific Considerations
Outlined in Annex B of BSE Inquiry Letter of 7th April 1999
1. The interaction which you and/or the Committee of which you were a member had
with the Department of Health and the various bodies constituted to advise it
(Medicines Control Agency, Committee for Safety of Medicines, the Biologicals Sub-
Committee, the Safety, Efficacy and Adverse Reactions Committee and the BSE
Working Group). In particular, to what extent were information and ideas shared?
Who instigated such action, in what forum did it take place and how was it
structured? What was the outcome?
The only formal interaction that I or other members of the VPC had with DoH was
through the representatives of DoH who attended VPC meetings. Any information from
the other committees mentioned came via officials of MAFF, CVL or VMD, who had
attended meetings of the Biological Sub-Committee of CSM and the BSE Working
Group.
2. The information and knowledge which was in the possession of the committee of
which you were a member regarding bovine and ovine materials in veterinary
medicines prior to the identification of BSE in cattle.
Information was contained in individual licence applications granted after the 1968 Act
[L12 Part A].
3. The approach subsequently taken to gathering, collating and analysing information
as to the bovine and ovine ingredients in veterinary medical products.
Following the issue of the 1989 Guidelines on Spongiform Encephalopathies of Bovine,
Ovine and Caprine Origin: Guidance on Good Manufacturing Practice and Request for
Information [YB89/3.15/4.1-4.4], these were rigorously applied by the VPC to all new
applications seen and to the products seen under the review of products licensed prior to
1984.
Following collation and analysis of the returns on the questionnaires issued by VMD in
March 1989, existing products were treated in the same way.
4. The formulation of the joint Committee for the Safety of Medicines/Veterinary
Products Committee Guidelines for Industry issued in March 1989 and of any
revision of these guidelines.
These guidelines were originally drafted by officials at the Medicines Unit, CVL and
their counterparts at the Department of Health.
They were then considered by the CSM and the VPC at individual meetings and, with a
few suggested amendments, approved.
These were superseded by CVMP Guidelines first published in January 1993
[YB93/1.00/4.1-4.6].
5. The procedures adopted and action taken to ensure compliance with those
guidelines. In particular, what policy was adopted with regard to manufacturers’
existing stocks of medicinal products which contained bovine ingredients and what
information was gathered as to manufacturers’ compliance with that policy? What
structures were adopted for ensuring compliance in general?
Compliance was handled by VMD. The VPC received reports where there was a potential
problem with compliance and advice was offered (see [YB90/11.00/5.1-5.2] and (Annex
12)).
6. The policy adopted in relation to the licensing of veterinary medicines and the
changes in that policy over the relevant period.
The main changes relate to those recommended in the 1989 Guidelines [YB89/3.15/4.1-
4.4] and those produced by the CVMP in 1993 [YB93/1.00/4.1-4.6]. The source and
origins of tissue material used in veterinary medicines, in particular bovine material,
became key quality and safety issues.
7. Research undertaken or investigations made in order to assess the risk to cattle
and/or other animals and/or humans from the use of medicines (veterinary or
otherwise) containing bovine material. In particular, what assessment was made of
the risks associated with different routes of infectivity?
Neither I nor, to my knowledge any VPC member, recommended any particular research
in relation to BSE/veterinary medicines.
Risks associated with different routes of infectivity were dealt with on a product-byproduct
application basis. I and the VPC members were aware of the order of infectivity
identified for scrapie from previous studies and emphasised in the CVMP guidelines of
1993. This was based on a titration of infectivity in mice by the intracerebral route.
8. What consideration if any was given to the risk associated with: (a) the use of bovine
pituitary hormones, both to stimulate ovulation in cattle and otherwise and (b) the
use of ovine materials in veterinary medicines, both in the period before and after
the identification of BSE in cattle?
a. The VPC considered possible contamination of medicines with the BSE agent in July
1988 while assessing guidelines for the review of products containing hormones at the
request of the Medicines Unit. The need for any risk of contamination with BSE to be
considered with substances derived from glandular extracts intended for use in the
treatment of ruminants was highlighted during the discussions concerning hormonal
products in 1988 already referred to (See Paragraph 6 – Chronology of the BSE
discussions at VPC). This discussion included bovine pituitary hormones.
b. The need to avoid the use of ovine brain material, or indeed, any ovine material with the
potential to contaminate medicines with the scrapie agent is dealt with under MAL67 -
MAFF’s 1983 guide to the use of substances of animal origin in the manufacture of
veterinary vaccines [YB83/6.00/1.1-1.4]. As mentioned previously, risk was assessed
with individual product applications. The Committee and I were aware that scrapie had
been disseminated via a louping ill vaccine (I think in the late 1940s or early 1950s) in
which brain and spleen tissue from scrapie-infected sheep had been inadvertently
incorporated.
http://www.bseinquiry.gov.uk/files/ws/s477.pdf
The case of company Z
Whilst the Inquiry revealed some of the secret workings of government,
pharmaceutical companies have been protected by confidentiality clauses
in the 1968 Medicines Act. The Inquiry was warned not to mention their
names—instead the word "redacted" appears in the transcripts.
The Inquiry heard how investigations found there were 111 medicines
administered by injection using the most risky by-products—brain and lymph.
Most were made from imported material, but a range of homeopathic medicines
and surgical sutures were not. The sutures used for sewing up tissues after
operations were manufactured by the main British supplier referred to as "Z".
They were made from cleaned cow intestines that the company processed at the
rate of 2,500 a day. Against the advice of their own guidelines, officials
renewed the licence on condition the company used intestines from clean beef
cattle 18 months to two years old.
A minority recommended the use of intestines from BSE-free countries. The Inquiry
was shown minutes where officials pointed out that “the agreement with the Company
is ‘confidential' so that there will be no direct comparisons” between the
conditions they had set and the recent ban on offals, including intestines,
for human consumption. Four years later, government officials announced that
a study had detected BSE infectivity at the end of the small intestine from
calves as young as six months old.
By July 1992 the BSE Inquiry was told all vaccines available in Britain fully complied
with the guidelines and did not use British cattle by-products. By the end of the same
year 40,000 cattle had shown symptoms of BSE. The number incubating BSE was much larger.
But what of the stocks of vaccines? According to the Daily Telegraph, the BSE Inquiry
has failed to establish what happened to them and “pharmaceutical companies have so far
declined to volunteer the information”. One Inquiry spokesperson said, “It is possible
that we will never know whether all these vaccines were destroyed or whether they were
used.” All the Labour Health Minister, Tessa Jowell would say is they were
“not disposed of or discontinued”. ...end
IATROGENIC DISEASE IN ANIMALS
http://www.iica.org.ar/Bse/6-%20Bradley.html
Ray Bradley
Private BSE Consultant
Veterinary Laboratories Agency, United Kingdom
There have been two reported incidents of iatrogenic disease in animals,
both involving scrapie. One was in Great Britain (Gordon, Brownlee and
Wilson, 1939, Gordon 1946, 1959) the other in Italy (Capucchio et al, 1998,
Agrimi et al, 1999). Both resulted from infection being
introduced into vaccines, louping ill vaccine in Great Britain, Mycoplasma
agalactiae vaccine in Italy. Each of these vaccines was prepared from
tissues that included sheep brain. In both episodes it seems most likely
that natural scrapie infection was present unknowingly in some brains used
for the purpose. Once prepared and having passed all the conventional
vaccine tests large numbers of sheep in Great Britain, and goats and some
sheep in Italy were inoculated. After the necessary incubation period large
numbers (> 1,000 in each case) of inoculated animals came down with scrapie.
In the meantime some inoculated clinically healthy goats and sheep may have
entered food and feed chains or have been used for other purposes. In the
British outbreak there appears to have been no consequence for humans who
may have consumed infected sheep. It is too early to say what may be the
consequences in Italy but measures have been taken to reduce any risk there
may have been. .........end
Louping-ill vaccine documents from November 23rd, 1946 FULL TEXT
THE VETERINARY RECORD
516 No 47. Vol. 58
November 23rd, 1946
NATIONAL VETERINARY MEDICAL ASSOCIATION OF GREAT BRITAIN AND IRELAND
ANNUAL CONGRESS, 1946
The annual Congress, 1946, was held at the Royal Veterinary College,
Royal College Street, London, N.W.I. from September 22nd to September
27th.
Opening Meeting
[skip to scrapie vaccine issue...tss]
Papers Presented to Congress
SNIP...FULL TEXT ;
http://whale.to/v/singeltary.html
although 176 products do _not_ conform to the CSM/VPC
guidelines.
http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf
8. The Secretary of State has a number of licences. We understand that
the inactivated polio vaccine is no longer being used. There is a stock
of smallpox vaccine. We have not been able to determine the source
material. (Made in sheep very unlikely to contain bovine ingredients).
http://www.bseinquiry.gov.uk/files/yb/1989/02/14010001.pdf
http://www.bseinquiry.gov.uk/files/yb/1989/02/14011001.pdf
Draft cover letter to product licence holders
(considered by Human and Vet Medicines including deer)
http://www.bseinquiry.gov.uk/files/yb/1989/02/22008001.pdf
http://www.bseinquiry.gov.uk/files/yb/1989/02/22011001.pdf
2.3.Iatrogenic exposure
Iatrogenic exposure of scrapie has probably occurred twice. The first report determined that
the vehicle was a louping ill vaccine prepared from sheep tissues and this infected a large
number of sheep sheep (Gordon, 1946, Greig, 1950). The second was more recent and in this
case a vaccine against Mycoplasma agalactiae prepared from sheep tissues was incriminated
(Agrimi et al 1999, Capucchio, 1998) but not all outbreaks could be linked to the use of the
vaccine. In this episode goats were predominantly affected10.
http://ec.europa.eu/food/fs/sc/ssc/out170_en.pdf
http://ec.europa.eu/food/fs/sc/ssc/out247_en.pdf
5.3.3 The greatest risk, in theory, would be from parenteral injection of material derived
from bovine brain or lymphoid tissue. Medicinal products for injection or surgical implantation
which are prepared from bovine tissues, or which utilise bovine serum albumin or similar agents
in their manufacture, might also be capable of transmitting infectious agents. All medicinal
products are licensed under the Medicines Act by the Licensing Authority following guidance,
for example from the Committee on Safety of Medicines (CSM), the Committee on Dental and Surgical
Materials (CDSM) and their subcommittees. The Licensing Authority have been alerted to potential
concern about BSE in medicinal products and will ensure that scrutiny of source materials and
manufacturing processes now takes account of BSE agent.
http://www.bseinquiry.gov.uk/files/ib/ibd1/tab02.pdf
The documents below were provided by Terry S. Singeltary Sr on 8 May 2000.
They are optically character read (scanned into computer) and so may contain
typos and unreadable parts.
TIP740203/l 0424 CONFIDENTIAL
Mr Cunningham CMP3 From: D O Hagger MBI
Dr Salisbury MED/IMCD3
Mr Burton PD/STB/PG1B B/17/2 Date: 15.02.1989
Mr Dudley PD/AD4
BOVINE SPONGIFORM ENCEPHALOPATHY
1. The purpose of this minute is to alert you to recent developments on
BSE as they affect medicines and to invite representatives to a meeting
in Market Towers on 22 February 1989.
2. The report of the Working Party on Bovine Spongiform
Encephalopathy (BSE) was submitted by the CMO to the Secretary of State
for Health and Minister for Agriculturer on 9 February.
3. The summary at the end of the report records, inter alia: 'we have
drawn the attention of the Licensing Authority to the potential of
transfer of BSE agent in human and veterinary medicinal products. In
paragraph 7 of his submission (Annex A), the CMO notes:
"I am also putting work urgently in hand to satisfy myself that
everything possible has been done to ensure .... that transfer of the
BSE agent in human and veterinary medicinal products does not occur."
4. The Veterinary products Committee meets on 16 February and The
committee on Safety of Medicines on 23 February when each will be
considering a draft of some joint guidelines for manufacturers of
medicinal products which use bovine material as an ingredient or an
intermediate in the manufacturing process (Annex B).....
6. Although a wide range of medicines may be implicated - and the
present proposal is to write to companies for more information - an
"instant" telephone survey of manufacturer of vaccines used for children
has already been undertaken in response to a request from Dr Harris. The
results are in Dr Adams' minute of 14 February (Annex C) - the proviso
in his second paragraph, last sentence should be noted.
89/02.15/11.1
89/02.15/11.2
MF580439/1 0584
SOUTHWOOD REPORT: BSE AND MEDICINAL PRODUCTS
1. I attach a list of questions on BSE and medicines compiled with the
aim of providing question and answer briefing to DH and MAFF Ministers
upon publication of the Southwood Report. I have suggested names of
those who may be able to provide answers.
All recipients are invited to consider which if any important areas have
been missed. Also attached is copy QA briefing being proposed by MAFF. I
understand MAFF have produced General QA briefing on the reports as a
whole.
..
MF580439/1 0585 Question
1. Which medicines are affected? (person to provide reply) Dr. Jefferys
2. Are the risks greater with some medicines than others? Dr. Jefferys
3. Why are medicines affected? Dr. Jefferys
4. Are some affected products available over the counter from pharmacies or shops? Dr. Purves
5. Are only UK products at risk? Dr. Jefferys
6. Are existing stocks safe? Dr. Jefferys
7. Are pre 1980 stocks available? Mr. Burton
8. Are these alternatives to the use of bovine material? Dr. Purves
9. Why can't we throw away suspect stock and import or manufacture safe medicines? Dr. Jefferys
10. Which patients are at risk? Dr. Jefferys
11. Are some patients particularly vulnerable? Dr Jefferys
12. What risks exist to those who have already used these medicines? Dr. Jefferys
13. HOW might patients be affected? Dr. Jefferys
14. Can BSE be transmitted to patients by medicines? Dr. Jefferys
15. How long will it be before risks are quantified? Dr. Jefferys
100 89/02.17/10.2 MF580439/1 0586
16. What research is going on to find out if medicines can transmit this disease and if any
patients have been affected? Dr Jefferys
17. Could recent cases of Creuuzfeld Jacob Disease have been caused by transmission of BSE through medicines? Dr. Jefferys
18. What action is the Licensing Authority taking to ensure proper scrutinising of source materials and manufacturing processes? Dr. Jefferys/Dr. Purves
19. Are the guidelines practical? Dr. Jefferys/Dr. Purves
20. Will the guidelines remove the risk? Dr. Jefferys
21. How will the guidelines be enforced? Dr. Jefferys/Dr. Purves
22. How soon will they come into force? Dr. Jefferys
23. Will the guidelines be published? Mr. Hagger
24. What is being done to reassure patients, parents etc? Mr. Hagger/Dr. Salisbury
25. What advice is being given to doctors, pharmacists etc? Mr. Hagger
26. What advice is the Government giving about its vaccination programme? Dr. Salisbury
27. Is the vaccination programme put at risk because of BSE? Dr. Salisbury
89/02.17/10.3
Q. Will government act on this?
A. Yes - thymus is not used in preparation of baby foods but it is
contacting all manufacturers to seek their urgent views on use of
kidneys and liver from ruminants. Will consider any necessary measures
in the light of their response.
VETERINARY MEDICINES
Q. Can medicines spread BSE to other cattle/animals?
A. The report describes any risks as remote.
Q. How can risks be avoided?
A. In liaison with the DOH the Veterinary Products Committee is
examining guidelines for the veterinary pharmaceutical industry
which will be issued shortly.
Q. What will Guidelines say?
A. In essence they call for non-bovine sources to be used if possible,
including synthetic material of biotechnological origin. Where this is
not possible the industry should look for sources which are free of BSE
and which are collected in a manner which avoids risk of contamination
by the BSE agent.
89/02.17/10.4 MF580439/1 0588
A. Bovine source material is used in [garbled, cannot read...TSS] and some other medicines.
Q. How many medicines are involved?
A. Computer records show that about 300 of the 3,050 veterinary
medicines licensed in the U.K. are manufactured directly from bovine
source material. However, other medicines may be produced from
bovine sources and a letter is going to all license holders so that a
comprehensive list can be drawn up.
89/06.19/8.1 BSE3/1 0191 Hr J Maslin (MAFF) Ref: Maslin3g
From: Dr H Pickles Med SEB/B Date: 3 July 1989
CATTLE BY-PRODUCTS AND BSE
I was interested to see the list of by-products sent to the HSE. Those
of particular concern included:
* small intestines: sutures (I thought the source was ovine but you are
checking this)
* spinal cord: pharmaceuticals
* thymus: pharmaceuticals
Are you able to give me more information on which UK manufacturers use
these materials? Our proposed ban on bovine offal for human consumption
would not affect these uses, I assume.
Id No. 1934/RD/1 89/08.10/6.1 117A
BOVINE SPONGIFORM ENCEPHALAPATHY MEETING
HELD ON 21 AUGUST 1989 AT 2;15 IN ROOM 720
Miss M Duncan (Chairman)
Mr W Burton
Dr E Hoxey
Mrs J Dhell
Ms K Turner
Dr S Whittle
Mr N Weatherhead
...
5. The MCA had sent 2700 questionnaires out, 1,124 had made valid
returns; of these 122 use animal material of some kind and there are 582
products involved.
...
6. The MCA/BSE working group will meet on 6th September. Their
aim is to review responses from professional officers in MCA who have
suggested seven categories of importance (with 1 being the most
important} for medical products:
ID 2267/NRE/1 89/08.21/10.1
1. Products with Bovine brain/lymph tissue administered by injection.
2. Products with bovine tissue other than brain/lymph administered by
inection.
3. Tissue implants/open wound dressing/surgical materials/dental and
ophthlamic products with bovine ingredients.
4. Products with bovine ingredients administered topically.
5. Products with bovine ingredients administered orally.
6. Products with other animal/fish/insect/bird ingredients administered
by injection/topically/oral routes.
7. Products with ingredients derived from animal material by chemical
processing (eg stearic acid, gelatine, lanolin ext.
The BSE working group will decide which of these are important, and
should be examined more closely, and which categories can be eliminated.
The responses by the companies were presented by Ms Turner and were
categorised by MCA standards, the products that were discussed were all
low volume usage products eg sutures, heart valves.
8. As the responses included some materials of human origin it
was decided that more information should be sought about CJD. There had
been 2 recent deaths reported associated with human growth hormone.
These were being investigated.
9. Re-editing of the Paper on "Incubation of Scrapie-like Agents"
It was suggested that the document could be sent out to companies with
the non-standard sterilization Document. The document could have severe
implications on the companies whose products have a high risk factor as
decided by the MCA working group....
11. The Need for a list of High Priority Implantables The commitee decided that no list is
necessary as all implantables, including ones from a human source are of high priority. Concern was
shown over Killingbeck who use human material but had not yet responded.
The company will be chased for a response. Concern was shown over the fact that there may be other scrapie-like
organisms in other animals and further enquiries should be made.
2334q/RD/4 89/08.21/10.7
BOVINE MATERIAL USED IN THE MANUFACTURE OF SURGICAL IMPLANTS AND
BLOOD CONTACT MEDICAL DEVICES
Glutaraldehyde, formaldehyde, and ethylene oxide are used in the
sterilization of these devices.
However, glutaraldehyde 4,10,12,19 formaldehyde 5,10,11,13,19 and
ethylene oxide 19,23 are all reported to be ineffective methods for
sterilization of material infected with the agents of CJD or scrapie.
Previous advice and research using the agents of CJD and scrapie, has
concentrated on the decontamination of equipment; protection of health
care workers from contaminated human material; human growth hormone; and
dura mater. The methods developed may not be directly applicable or
transferable to material of bovine origin for use in human implantation.
2334q/RD/7 89/08.21/10.10 BSE11/2 020 SC1337
DEPARTMENT OF HEALTH AND SOCIAL SECURITY
Richmood House 79 Whitehall, London SW1A 2NS
Telephone 01-210-3000
From the Chief Medical Officer
Sir Donald Acheson KBE DM DSc FRCP FFCM FFOM
Mr K C Meldrum
Chief Veterinary Officer
Ministry of Agriculture, Fisheries and Food
Government Buildings
Hook Rise South
Tolworth
Surbiton
Surrey
KT6 7NG
3 January 1990
Dear Mr. Meldrum,
BOVINE SPONGIFORM ENCEPHALOPATHY
You will recall that we have previously discussed the potential risks of
BSE occurring in other Countries as a result of the continuing export
from the UK of meat and bone that may be contaminated by scrapie or
possibly BSE.
I remain concerned that we are not being consistent in our attempts to
contain the risks of BSE. Having banned the feeding of meat and bone
meal to ruminants in 1988, we should take steps to prevent these UK
products being fed to ruminants in other countries. This could be
achieved either through a ban on the export of meat and bone meal, or at
least by the proper labelling of these products to make it absolutely
clear they should not be fed to ruminants. Unless some such action is
taken the difficult problems we have faced with BSE may well occur in
other countries who import UK meat and bone meal. Surely it is short
sighted for us to risk being seen in future as having been responsible
for the introduction of BSE to the food chain in other countries.
I would be very interested to hear how you feel this gap in the present
prcautionary measures to eliminate BSE should be closed. We should be
aiming at the global elimination of this new bovine disease. The export
of our meat and bone meal is a continuing risk to other countries.
Signed
Sincerely Donald Acheson
Did the US import fetal calf serum and vaccines from BSE-affected countries?
3002.10.0040: FETAL BOVINE SERUM (FBS)
U.S. Imports for Consumption: December 1998 and 1998 Year-to-Date
(Customs Value, in Thousands of Dollars)
(Units of Quantity: Kilograms)
<--- Dec 1998 ---> <--- 1998 YTD --->
Country Quantity Value Quantity Value
=================================================================
WORLD TOTAL . . . . . . . 2,727 233 131,486 8,502
Australia . . . . . . . . --- --- 19,637 2,623
Austria . . . . . . . . . --- --- 2,400 191
Belgium . . . . . . . . . --- --- 17 32
Canada . . . . . . . . . 900 110 30,983 3,220
Costa Rica . . . . . . . 500 20 4,677 169
Federal Rep. of Germany --- --- 105 21
Finland . . . . . . . . . 1 8 9 83
France . . . . . . . . . --- --- 73 7
Guatemala . . . . . . . . --- --- 719 42
Honduras . . . . . . . . --- --- 1,108 88
Israel . . . . . . . . . --- --- 24 165
Netherlands . . . . . . . --- --- 1 5
New Zealand . . . . . . . 26 5 65,953 913
Panama . . . . . . . . . --- --- 1,195 64
Switzerland . . . . . . . 971 8 1,078 23
United Kingdom . . . . . 329 82 743 756
Uruguay . . . . . . . . . --- --- 2,764 98
------------------------------------------------------------------
3002.20.0000: VACCINES FOR HUMAN MEDICINE
U.S. Imports for Consumption: December 1998 and 1998 Year-to-Date
(Customs Value, in Thousands of Dollars)
(Units of Quantity: Kilograms)
<--- Dec 1998 ---> <--- 1998 YTD --->
Country Quantity Value Quantity Value
=================================================================
WORLD TOTAL . . . . . . . 25,702 26,150 550,258 378,735
Austria . . . . . . . . . --- --- 45 225
Belgium . . . . . . . . . 14,311 12,029 248,041 199,036
Canada . . . . . . . . . 1,109 1,527 15,798 16,305
Denmark . . . . . . . . . 80 234 246 682
Federal Rep. of Germany 1,064 4,073 12,001 6,329
France . . . . . . . . . 3,902 4,859 87,879 92,845
Ireland . . . . . . . . . --- --- 120 478
Italy . . . . . . . . . . --- --- 2,359 81
Japan . . . . . . . . . . 445 1,903 11,350 11,298
Netherlands . . . . . . . --- --- 94 6
Republic Of South Africa --- --- 2 1
Spain . . . . . . . . . . --- --- 60 30
Switzerland . . . . . . . 716 353 9,303 4,271
United Kingdom . . . . . 4,075 1,172 162,960 47,148
------------------------------------------------------------------
3002.30.0000: VACCINES FOR VETRINARY MEDICINE
U.S. Imports for Consumption: December 1998 and 1998 Year-to-Date
(Customs Value, in Thousands of Dollars)
(Units of Quantity: Kilograms)
<--- Dec 1998 ---> <--- 1998 YTD --->
Country Quantity Value Quantity Value
=================================================================
WORLD TOTAL . . . . . . . 6,528 237 87,149 2,715
Canada . . . . . . . . . --- --- 2,637 305
Federal Rep. of Germany --- --- 104 5
Netherlands . . . . . . . 138 64 472 192
New Zealand . . . . . . . 6,390 173 83,882 1,895
United Kingdom . . . . . --- --- 54 318
http://www.mad-cow.org/00/may00_news.html
SEE HEART VALVES ;
http://www.mad-cow.org/00/may00_news.html#aaa
My submission to FDA about this ;
http://www.fda.gov/ohrms/dockets/dailys/00/mar00/030100/emc0597.rtf
http://www.fda.gov/OHRMS/DOCKETS/DOCKETS/96n0417/96N-0417-EC-2.htm
PDF]Freas, William TSS SUBMISSION
File Format: PDF/Adobe Acrobat -
Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary
Sr. [flounder [at] wt.net] Monday, January 08,200l 3:03 PM freas ...
http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf
Asante/Collinge et al, that BSE transmission to the 129-methionine
genotype can lead to an alternate phenotype that is indistinguishable
from type 2 PrPSc, the commonest _sporadic_ CJD;
http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm
Date: Sun, 7 Jan 2001 09:45:19 -0800
Reply-To: Sustainable Agriculture Network Discussion Group
<[log in to unmask]>
Sender: Sustainable Agriculture Network Discussion Group
<[log in to unmask]>
From: Beth von Gunten <[log in to unmask]>
Subject: [BSE] FDA/IMPORTANT NOTICE: 50 STATE CONFERENCE CALL
Content-Type: text/plain; charset="us-ascii" ; format="flowed"
IMPORTANT NOTICE: 50 STATE CONFERENCE CALL - BSE
TUESDAY, JANUARY 9, 2001
1:00-2:00 PM EST CALL: 1-888-273-9887
A special "50 STATE CONFERENCE CALL" to discuss BSE (Bovine
Spongiform Encephalopathy) issues for Food and Drug Administration
(FDA) regulated animal feed products in the United States and
imported animal feeds. The conference call will
discuss the FDA proposed response to the current BSE issue and the
assistance needed from state feed and agriculture programs. THIS
ISSUE MAY IMPACT ALL STATES AND ALL ANIMAL FEED AND PRODUCTION
INDUSTRIES.
The 50 State call is scheduled for Tuesday, January 9, 2001 from
1:00-2:00 pm EST. Any state agency responsible for animal feed issues
wishing to participate should call 1-888-273-9887 and ask to be
connected to the "50 State BSE Call". The conference host operator
will explain how to participate, including asking questions during
the call. If possible, please coordinate within your state to utilize
only one phone line per state agency.
We request that you forward this message to your agency management
and feed coordinators or other agencies or departments who may be
responsible for any animal feed issues related to FDA regulated
products.
The agenda will be as follows:
1. Center For Veterinary Medicine (FDA) - Discussion of the problem
related to BSE events in Europe and the impact on US feed ingredients
for animals and feed operations. Discussion of the proposed
actions/inspections/compliance of licensed and unlicensed feed mills,
commercial feed manufacturers, animal feed imports, renderer's,
protein blenders, on-farm mixers, and ruminant feeders.
2. Office of Regional Operations (FDA) - Discussion of
contracting/working with states to inspect the universe of feed
mills/industry for "Animal Proteins Prohibited from Use in Animal
Feed". Discussion of working with FDA field offices.
3. Questions and answers.
Richard H. Barnes, Director
Division of Federal-State Relations (HFC-150)
5600 Fishers Lane Room 1207
Rockville, Md. 20857
ph: (301) 827-6906 FAX: (301) 443-2143
Email: [log in to unmask]
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0101&L=sanet-mg&P=13410
Subject: U.S.A. - 50 STATE BSE CONFERENCE CALL JAN. 9, 2001 (my notes)
Date: January 10, 2001 at 1:36 pm PST
Subject: BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001
Date: Tue, 9 Jan 2001 16:49:00 -0800
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L [at] uni-karlsruhe.de
######### Bovine Spongiform Encephalopathy #########
Greetings List Members,
I was lucky enough to sit in on this BSE conference
call today and even managed to ask a question.
that is when the trouble started.
I submitted a version of my notes to
Sandra Blakeslee of the New York Times,
whom seemed very upset, and rightly
so.
"They tell me it is a closed meeting and
they will release whatever information
they deem fit. Rather infuriating."
and i would have been doing just fine,
until i asked my question. i was surprised
my time to ask a question so quick.
(understand, these are taken from my notes for now.
the spelling of names and such could be off.)
[host Richard Barns]
and now a question from Terry S. Singeltary of
CJD Watch.
[TSS]
yes, thank you,
U.S. cattle, what kind of guarantee can you
give for serum or tissue donor herds?
[no answer, you could hear in the back ground,
mumbling and 'we can't. have him ask the question
again.]
[host Richard]
could you repeat the question?
[TSS]
U.S. cattle, what kind of guarantee can you
give for serum or tissue donor herds?
[not sure whom ask this]
what group are you with?
[TSS]
CJD Watch, my Mom died from hvCJD and we are
tracking CJD world-wide.
[not sure who is speaking]
could you please disconnect Mr. Singeltary
[TSS]
you are not going to answer my question?
[not sure whom speaking]
NO
from this point, i was still connected, got to listen
and tape the whole conference. at one point someone
came on, a woman, and ask again;
[unknown woman]
what group are you with?
[TSS]
CJD Watch and my Mom died from hvCJD
we are trying to tract down CJD and other
human TSE's world wide. i was invited to
sit in on this from someone inside the USDA/APHIS
and that is why i am here. do you intend on banning
me from this conference now?
at this point the conference was turned back up,
and i got to finish listening. They never answered
or even addressed my one question, or even addressed
the issue. BUT, i will try and give you a run-down
for now, of the conference.
IF i were another Country, I would take heed to my
notes, BUT PLEASE do not depend on them. ask for
transcript from;
RBARNS [at] ORA.FDA.GOV
301-827-6906
he would be glad to give you one ;-)
Rockville Maryland,
Richard Barns Host
BSE issues in the U.S.,
How they were labelling ruminant feed?
Revising issues.
The conference opened up with the explaining of
the U.K. BSE epidemic winding down with about 30
cases a week.
although new cases in other countries were now
appearing.
Look at Germany whom said NO BSE and now have BSE.
BSE increasing across Europe.
Because of Temporary Ban on certain rendered product,
heightened interest in U.S.
A recent statement in Washington Post, said the
New Administration (old GW) has a list of issues.
BSE is one of the issues.
BSE Risk is still low, minimal in U.S. with a greater
interest in MBM not to enter U.S.
HOWEVER, if BSE were to enter the U.S.
it would be economically disastrous
to the render, feed, cattle, industries,
and for human health.
(human health-they just threw that in cause i was listening.
I will now jot down some figures in
which they told you, 'no need to write them down'.
just hope i have them correct. hmmm, maybe i hope
i don't ???)
80% inspection of rendering
*Problem-Complete coverage of rendering HAS NOT
occurred.
sizeable number of 1st time FAILED INITIAL INSPECTION,
have not been reinspected (70% to 80%).
Compliance critical, Compliance poor in U.K.
and other European Firms.
Gloria Dunason
Major Assignment 1998 goal TOTAL compliance.
This _did not_ occur. Mixed level of compliance,
depending on firm.
Rendering FDA license and NON FDA license
system in place for home rendering & feed
76% in compliance
79% cross contamination
21% DID NOT have system
92% record keeping
less than 60% total compliance
279 inspectors
185 handling prohibited materials
Renderer at top of pyramid, significant
part of compliance.
84% compliance
failed to have caution statement render
72% compliance & cross contamination
caution statement on feed, 'DO NOT FEED TO CATTLE'
56 FIRMS NEVER INSPECTED
1240 FDA license feed mills
846 inspected
"close to 400 feed mills have not been inspected"
80% compliance for feed.
10% don't have system.
NON-FDA licensed mills
There is NO inventory on non licensed mills.
approximately 6000 to 8000 Firms ???
4,344 ever inspected.
"FDA does not have a lot of experience with"
40% do NOT have caution statement 'DO NOT FEED'.
74% Commingling compliance
"This industry needs a lot of work and only half
gotten to"
"700 Firms that were falitive, and need to be
re-inspected, in addition to the 8,000 Firms."
Quote to do BSE inspection in 19 states by end
of January or 30 days, and other states 60 days.
to change feed status??? Contract check and ask
questions and pass info.
At this time, we will take questions.
[I was about the third or fourth to ask question.
then all B.S.eee broke loose, and i lost my train
of thought for a few minutes. picked back up here]
someone asking about nutritional supplements and
sourcing, did not get name. something about inspectors
not knowing of BSE risk??? the conference person assuring that Steve
Follum? and the TSE advisory Committee were
handling that.
Some other Dr. Vet, whom were asking questions
that did not know what to do???
[Dennis Wilson]
California Food Agr.
Imports, are they looking at imports?
[Conference person]
they are looking at imports,
FDA issued imports Bulletin.
[Linda Singeltary ??? this was a another phone in
question, not related i don't think]
Why do we have non-licensed facilities?
(conference person)
other feed mills do not handle as potent drugs???
Dennis Blank, Ken Jackson
licensed 400
non FDA 4400 inspected of a total of 6000 to 8000,
(they really don't know how many non licensed Firms
in U.S. they guess 6000 to 8000??? TSS)
Linda Detwiler
asking everyone (me) not to use emergency BSE number,
unless last resort.
(i thought of calling them today, and reporting the
whole damn U.S. cattle herd ;-) 'not'
Warren-Maryland Dept. Agr.
Prudent to re-inspect after 3 years.
concerned of Firms that have changed
owners.
THE END
TSS
############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ############
JANUARY 9, 2001 50 STATE BSE CONFERENCE CALL
http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html
http://www.fda.gov/OHRMS/DOCKETS/DOCKETS/96n0417/96N-0417-EC-2.htm
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0612&L=sanet-mg&D=0&T=0&P=1049
http://www.bioedonline.org/forums/messageview.cfm?thread=954
http://lists.iatp.org/listarchive/archive.cfm?id=121143
ALL the warnings have been there, most just chose to ignore them, now only time will tell who has to pay the final price.
sadly, some like Lester Crawford reaped the rewards of ignoring these risk factors $$$ you cannot put the wolf in guard
of the hen house, and the fda, usda, aphis, fsis, et al are full of these wolves guarding the hen houses ;
Sentencing Is Delayed in Case Of Former FDA Commissioner
ASSOCIATED PRESS
Former FDA Commissioner Lester Crawford's sentencing on charges he lied about his stock holdings was delayed Tuesday over
questions about sentencing guidelines. Under a deal worked out between his attorney and federal prosecutors, Mr. Crawford had
agreed earlier to a $50,000 fine and probation. Magistrate Judge Deborah A. Robinson asked the attorneys to explain why they didn't
use certain federal sentencing guidelines in ... snip...end
http://online.wsj.com/
no conflict of interest there right ???
WHAT else did old lester crawford lie about, and whom reaped what from that $$$
Press Release
FOR IMMEDIATE RELEASE
Monday, Jan. 26, 2004
FDA Press Office
301-827-6242
Expanded "Mad Cow" Safeguards Announced to Strengthen Existing Firewalls Against BSE Transmission
HHS Secretary Tommy G. Thompson today announced several new public health measures, to be implemented by the Food and
Drug Administration (FDA), to strengthen significantly the multiple existing firewalls that protect Americans from exposure to the agent
thought to cause bovine spongiform encephalopathy (BSE, also known as mad cow disease) and that help prevent the spread of BSE in U.S. cattle.
The existing multiple firewalls, developed by both the U.S. Department of Agriculture (USDA) and HHS, have been extremely effective in protecting
the American consumer from exposure to BSE. The first firewall is based on import controls started in 1989. A second firewall is surveillance of the
U.S. cattle population for the presence of BSE, a USDA firewall that led to the finding of the BSE cow in December. The third firewall is FDA's 1997
animal feed ban, which is the critical safeguard to help prevent the spread of BSE through cattle herds by prohibiting the feeding of most mammalian
protein to ruminant animals, including cattle. The fourth firewall, recently announced by USDA, makes sure that no bovine tissues known to be at high
risk for carrying the agent of BSE enter the human food supply regulated by USDA. The fifth firewall is effective response planning to contain the
potential for any damage from a BSE positive animal, if one is discovered. This contingency response plan, which had been developed over the past
several years, was initiated immediately upon the discovery of a BSE positive cow in Washington State December 23.
The new safeguards being announced today are science-based and further bolster these already effective safeguards.
Specifically, HHS intends to ban from human food (including dietary supplements), and cosmetics a wide range of bovine-derived material so that the
same safeguards that protect Americans from exposure to the agent of BSE through meat products regulated by USDA also apply to food products that
FDA regulates.
FDA will also prohibit certain currently allowed feeding and manufacturing practices involving feed for cattle and other ruminant animals. These additional
measures will further strengthen FDA's 1997 "animal feed" rule.
"Today's actions will make strong public health protections against BSE even stronger," Secretary Thompson said. "Although the current animal feed
rule provides a strong barrier against the further spread of BSE, we must never be satisfied with the status quo where the health and safety of our
animals and our population is at stake. The science and our own experience and knowledge in this area are constantly evolving. Small as the risk
may already be, this is the time to make sure the public is protected to the greatest extent possible."
"Today we are bolstering our BSE firewalls to protect the public," said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "We are further strengthening
our animal feed rule, and we are taking additional steps to further protect the public from being exposed to any potentially risky materials from cattle.
FDA's vigorous inspection and enforcement program has helped us achieve a compliance rate of more than 99 percent with the feed ban rule, and we
intend to increase our enforcement efforts to assure compliance with our enhanced regulations. Finally, we are continuing to assist in the development
of new technologies that will help us in the future improve even further these BSE protections. With today's actions, FDA will be doing more than ever
before to protect the public against BSE by eliminating additional potential sources of BSE exposure."
To implement these new protections, FDA will publish two interim final rules that will take effect immediately upon publication, although there will be an
opportunity for public comment after publication.
The first interim final rule will ban the following materials from FDA-regulated human food, (including dietary supplements) and cosmetics:
Any material from "downer" cattle. ("Downer" cattle are animals that cannot walk.)
Any material from "dead" cattle. ("Dead" cattle are cattle that die on the farm (i.e. before reaching the slaughter plant);
Specified Risk Materials (SRMs) that are known to harbor the highest concentrations of the infectious agent for BSE, such as the brain,
skull, eyes, and spinal cord of cattle 30 months or older, and a portion of the small intestine and tonsils from all cattle, regardless of their age or health;
and
The product known as mechanically separated beef, a product which may contain SRMs. Meat obtained by Advanced Meat Recovery (an
automated system for cutting meat from bones), may be used since USDA regulations do not allow the presence of SRMs in this product.
The second interim final rule is designed to lower even further the risk that cattle will be purposefully or inadvertently fed prohibited protein. It was the
feeding of such protein to cattle that was the route of disease transmission that led to the BSE epidemic in United Kingdom cattle in the 1980's and 1990's.
This interim final rule will implement four specific changes in FDA's present animal feed rule. First, the rule will eliminate the present exemption in the feed
rule that allows mammalian blood and blood products to be fed to other ruminants as a protein source. Recent scientific evidence suggests that blood can
carry some infectivity for BSE.
Second, the rule will also ban the use of "poultry litter" as a feed ingredient for ruminant animals. Poultry litter consists of bedding, spilled feed, feathers,
and fecal matter that are collected from living quarters where poultry is raised. This material is then used in cattle feed in some areas of the country where
cattle and large poultry raising operations are located near each other. Poultry feed may legally contain protein that is prohibited in ruminant feed, such as
bovine meat and bone meal. The concern is that spillage of poultry feed in the chicken house occurs and that poultry feed (which may contain protein
prohibited in ruminant feed) is then collected as part of the "poultry litter" and added to ruminant feed.
Third, the rule will ban the use of "plate waste" as a feed ingredient for ruminants. Plate waste consists of uneaten meat and other meat scraps that are
currently collected from some large restaurant operations and rendered into meat and bone meal for animal feed. The use of "plate waste" confounds
FDA's ability to analyze ruminant feeds for the presence of prohibited proteins, compromising the Agency's ability to fully enforce the animal feed rule.
Fourth, the rule will further minimize the possibility of cross-contamination of ruminant and non-ruminant animal feed by requiring equipment, facilities or
production lines to be dedicated to non-ruminant animal feeds if they use protein that is prohibited in ruminant feed. Currently, some equipment, facilities
and production lines process or handle prohibited and non-prohibited materials and make both ruminant and non-ruminant feed -- a practice which could
lead to cross-contamination.
To accompany these new measures designed to provide a further layer of protection against BSE, FDA will in 2004 step up its inspections of feed mills
and renderers. FDA will itself conduct 2,800 inspections and will make its resources go even further by continuing to work with state agencies to fund 3,100
contract inspections of feed mill and renderers and other firms that handle animal feed and feed ingredients. Through partnerships with states, FDA will also
receive data on 700 additional inspections, for a total of 3,800 state contract and partnership inspections in 2004 alone, including annual inspections of 100
percent of all known renderers and feed mills that process products containing materials prohibited in ruminant feed.
"We have worked hard with the rendering and animal feed production industries to try and achieve full compliance with the animal feed rule," said Dr. McClellan,
"and through strong education and a vigorous enforcement campaign, backed by additional inspections and resources, we intend to maintain a high level of compliance."
Dr. McClellan also noted that, in response to finding a BSE positive cow in Washington state December 23, FDA inspected and traced products at 22 facilities related
to that positive cow or products from the cow, including feed mills, farms, dairy farms, calf feeder lots, slaughter houses, meat processors, transfer stations, and
shipping terminals. Moreover, FDA has conducted inspections at the rendering facilities that handled materials from the positive cow, and they were found to be
fully in compliance with FDA's feed rule.
To further strengthen protections for Americans, FDA/HHS intends to work with Congress to consider proposals to assure that these important protective measures
will be implemented as effectively as possible.
FDA is also continuing its efforts to assist in the development of better BSE science, to achieve the same or greater confidence in BSE protection at a lower cost.
For example, to enhance the ability of our public health system to detect prohibited materials in animal feed, FDA will continue to support the development and
evaluation of diagnostic tests to identify prohibited materials. These tests would offer a quick and reliable method of testing animal feeds for prohibited materials
and for testing other products for contamination with the agent thought to cause BSE.
FDA has publicly discussed many of the measures being announced today with stakeholders in workshops, videoconferences, and public meetings. In addition,
FDA published an Advance Notice of Proposed Rulemaking in November 2002 (available online at http://www.fda.gov/OHRMS/DOCKETS/98fr/110602c.htm
concerning possible changes to the animal feed rule.
Comprehensive information about FDA's work on BSE and links to other related websites are available at http://www.fda.gov.
###
http://www.fda.gov/bbs/topics/news/2004/hhs_012604.html
STATEMENT
BY
LESTER M. CRAWFORD, D.V.M., PH.D.
DEPUTY COMMISSIONER OF FOOD AND DRUGS
DEPARTMENT OF HEALTH AND HUMAN SERVICES
BEFORE
THE COMMITTEE ON AGRICULTURE, NUTRITION, AND FORESTRY
UNITED STATES SENATE
JANUARY 27, 2004
Introduction
Mr. Chairman, Members of the Committee, thank you for the opportunity to participate in today’s hearing on measures taken by the Federal government to
safeguard human and animal health in the United States from Bovine Spongiform Encephalopathy (BSE) and the response to the finding of a BSE-positive
cow in the State of Washington. I am Dr. Lester M. Crawford, Deputy Commissioner, Food and Drug Administration (FDA or the Agency).
The mission of FDA is to protect the public health by assuring the safety and efficacy of our nation’s human and veterinary drugs, human biological products,
medical devices, human and animal food supply, cosmetics, and radiation emitting products. In fulfilling this mission, FDA is the Agency responsible for
assuring that all FDA-regulated products remain safe and uncompromised from BSE and related diseases. Many FDA-regulated products contain bovine
ingredients, for example, heart valves, ophthalmic devices, dental products, wound dressings, injectable drugs, vaccines, soups, gravies, sausage casings,
and animal feeds.
FDA has long been actively involved nationally and internationally in efforts to understand and prevent the spread of BSE. FDA collaborates extensively with
the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the Animal and Plant Health Inspection Service (APHIS) and
the Food Safety and Inspection Service (FSIS) within the U.S. Department of Agriculture (USDA), Customs and Border Protection (CBP), the Environmental
Protection Agency (EPA), other Federal agencies, state and local jurisdictions, and with affected industries and consumer groups. Many of these activi
COMMENT SUBMISSION TO ;
Docket No. 2005N-0373
and RIN number 0910-AF54
[Federal Register: January 12, 2007 (Volume 72, Number 8)]
[Proposed Rules]
[Page 1581-1619]
Docket No. 2005N-0373
and RIN number 0910-AF54
Use of Materials Derived from Cattle in Medical Products Intended for
Use in Humans and Drugs Intended for Use in Ruminants; Proposed Rule
snip...
SUMMARY: The Food and Drug Administration (FDA) is proposing to
prohibit the use of certain cattle material in, or in the manufacture
(including processing) of, drugs, biologics, and medical devices
intended for use in humans and human cells, tissues, and cellular and
tissue-based products (HCT/Ps) (collectively, medical products for
humans), and in drugs intended for use in ruminant animals (drugs for
ruminants). FDA is also proposing new recordkeeping requirements for
medical products for humans and drugs for ruminants that are
manufactured from or otherwise contain material from cattle. FDA is
proposing these actions as part of its continuing efforts to strengthen
defenses against the potential risk of exposure to, and spread of,
bovine spongiform encephalopathy (BSE) and related human disease in the
United States.
DATES: Submit written or electronic comments on the proposed rule by
March 13, 2007. Submit written comments on the information collection
requirements by February 12, 2007. Requests for an informal hearing on
the proposed ban related to medical devices must be submitted by
February 12, 2007.
ADDRESSES: You may submit comments, identified by Docket No. 2005N-0373
and RIN number 0910-AF54, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following ways:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Agency Web site: http://www.fda.gov/dockets/ecomments.
snip...end
http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/E6-22329.htm
TSS SUBMISSION TO ;
Docket No. 2005N-0373
and RIN number 0910-AF54
Greetings FDA et al,
ONCE again I would kindly like to comment on the continuous failed attempts
by the FDA to regulate the use of certain cattle material in, or in the manufacture
including processing) of, drugs, biologics, and medical devices
intended for use in humans and human cells, tissues, and cellular and
tissue-based products (HCT/Ps) (collectively, medical products for
humans), and in drugs intended for use in ruminant animals (drugs for
ruminants) from the proven risk factors of Transmissible Spongiform Encephalopahy
i.e. TSE's in all species. I have continued to warn the FDA et al about these
risk factors via the surgical and medical arena (vaccines, nutritional supplements,
bovine heart valves, and other animal donor tissue), and I have continued to point
out the risk factor of the UKBSENVCJD only theory, and the ramifications there from,
i.e. BASE (bovine amyloidotic spongiform encephalopathy), and my greatest fears, one
I have warned you about time and time again, seems to be coming true ;
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. A study also demonstrated that in a
mouse model it was possible to alleviate the pathological changes of prion
disease by suppressing expression of the prion protein gene after infection.
http://www.seac.gov.uk/minutes/95.pdf
3:00 Afternoon Refreshment Break, Poster and Exhibit Viewing in the Exhibit
Hall
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
Volume 12, Number 12–December 2006
PERSPECTIVE
On the Question of Sporadic or Atypical Bovine Spongiform Encephalopathy and
Creutzfeldt-Jakob Disease
http://www.cdc.gov/ncidod/EID/vol12no12/06-0965.htm?s_cid=eid06_0965_e
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
Disturbingly, we now know that the USA has had, beyond any shadow of a doubt, been
circulating TSE in a very wide variety of products, and have been for decades. Even
more disturbingly, we now have to deal with, whether or not the industry like it or not,
atypical TSE i.e. BASE in the USA. NOW we have the 4th documented vCJD transfusion related
case in the U.K., this raises serious questions about blood and tissue related products in
relations to TSE transmission from all species ;
Date: January 18, 2007 at 8:32 am PST
Fourth case of transfusion-associated vCJD infection in the United Kingdom
Editorial team (eurosurveillance.weekly [at] hpa.org.uk), Eurosurveillance editorial office
A suspected 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:
snip...
http://www.eurosurveillance.org/ew/2007/070118.asp#4
SEE ALSO ;
HPA Press Statement
18 January 2007
4th case of variant CJD infection associated with blood transfusion
http://www.hpa.org.uk/hpa/news/articles/press_releases/2007/070118_vCJD.htm
ONCE again I must warn you that the USA is in a most unique situation, one of unknown
circumstances with human and animal TSE. THE USA has the most documented TSE in different
species to date, with substrains growing in those species (BSE/BASE in cattle and CWD in
deer and elk, there is evidence here with different strains), and we know that sheep scrapie
has over 20 strains of the typical scrapie with atypical scrapie documented and also BSE is
very likely to have passed to sheep. all of which have been rendered and fed back to animals
for human and animal consumption, a frightening scenario. WE do not know the outcome, and to
play with human life around the globe with the very likely TSE tainted blood and tissue from
the USA bovine, in my opinion is like playing Russian roulette, of long duration, with potential
long and enduring consequences, of which once done, cannot be undone. These are the facts as I
have come to know through daily and extensive research of TSE over 9 years, since 12/14/97. I tried
to warn back in 2001, at the infamous Jan. 9, 2001 50 STATE BSE CONFERENCE CALL that the USA indeed
was still feeding ruminant protein to 'tissue and blood donor herds', to no avail.
I do not pretend to have all the answers, but I do know to continue to believe in the ukbsenvcjd only
theory of transmission to humans of only this one strain from only this one TSE from only this one
part of the globe, will only lead to further failures, and needless exposure to humans from all strains
of TSE, and possibly many more needless deaths from TSE via a multitude of proven routes and sources via
many studies with primates and rodents and other species. ...
WE have known about risk factors of Scrapie Associated Fibers i.e. SAFs and ignored
the '1968 MEDICINE ACT' ;
http://www.bseinquiry.gov.uk/files/yb/1989/01/30008001.pdf
http://www.bseinquiry.gov.uk/files/ws/s469.pdf
The BSE Inquiry / Statement No 477
Professor Sir James Armour
Issued 07/07/1999
snip...
Summary
Although the letter from the BSE Inquiry requesting evidence was addressed to me, I have
presented the course of events as handled by the VPC under my chairmanship. There was very
good agreement between the Committee and myself on the advice given to the Medicines Unit,
VMD and the Licensing Authority. Advice given through 1988 and 1989 centred on the
development of Guidelines, both UK and European, in relation to the source and tissues of origin
of materials used in the manufacture of veterinary products (and their sterilisation).
Answers to Specific Considerations
Outlined in Annex B of BSE Inquiry Letter of 7th April 1999
1. The interaction which you and/or the Committee of which you were a member had
with the Department of Health and the various bodies constituted to advise it
(Medicines Control Agency, Committee for Safety of Medicines, the Biologicals Sub-
Committee, the Safety, Efficacy and Adverse Reactions Committee and the BSE
Working Group). In particular, to what extent were information and ideas shared?
Who instigated such action, in what forum did it take place and how was it
structured? What was the outcome?
The only formal interaction that I or other members of the VPC had with DoH was
through the representatives of DoH who attended VPC meetings. Any information from
the other committees mentioned came via officials of MAFF, CVL or VMD, who had
attended meetings of the Biological Sub-Committee of CSM and the BSE Working
Group.
2. The information and knowledge which was in the possession of the committee of
which you were a member regarding bovine and ovine materials in veterinary
medicines prior to the identification of BSE in cattle.
Information was contained in individual licence applications granted after the 1968 Act
[L12 Part A].
3. The approach subsequently taken to gathering, collating and analysing information
as to the bovine and ovine ingredients in veterinary medical products.
Following the issue of the 1989 Guidelines on Spongiform Encephalopathies of Bovine,
Ovine and Caprine Origin: Guidance on Good Manufacturing Practice and Request for
Information [YB89/3.15/4.1-4.4], these were rigorously applied by the VPC to all new
applications seen and to the products seen under the review of products licensed prior to
1984.
Following collation and analysis of the returns on the questionnaires issued by VMD in
March 1989, existing products were treated in the same way.
4. The formulation of the joint Committee for the Safety of Medicines/Veterinary
Products Committee Guidelines for Industry issued in March 1989 and of any
revision of these guidelines.
These guidelines were originally drafted by officials at the Medicines Unit, CVL and
their counterparts at the Department of Health.
They were then considered by the CSM and the VPC at individual meetings and, with a
few suggested amendments, approved.
These were superseded by CVMP Guidelines first published in January 1993
[YB93/1.00/4.1-4.6].
5. The procedures adopted and action taken to ensure compliance with those
guidelines. In particular, what policy was adopted with regard to manufacturers’
existing stocks of medicinal products which contained bovine ingredients and what
information was gathered as to manufacturers’ compliance with that policy? What
structures were adopted for ensuring compliance in general?
Compliance was handled by VMD. The VPC received reports where there was a potential
problem with compliance and advice was offered (see [YB90/11.00/5.1-5.2] and (Annex
12)).
6. The policy adopted in relation to the licensing of veterinary medicines and the
changes in that policy over the relevant period.
The main changes relate to those recommended in the 1989 Guidelines [YB89/3.15/4.1-
4.4] and those produced by the CVMP in 1993 [YB93/1.00/4.1-4.6]. The source and
origins of tissue material used in veterinary medicines, in particular bovine material,
became key quality and safety issues.
7. Research undertaken or investigations made in order to assess the risk to cattle
and/or other animals and/or humans from the use of medicines (veterinary or
otherwise) containing bovine material. In particular, what assessment was made of
the risks associated with different routes of infectivity?
Neither I nor, to my knowledge any VPC member, recommended any particular research
in relation to BSE/veterinary medicines.
Risks associated with different routes of infectivity were dealt with on a product-byproduct
application basis. I and the VPC members were aware of the order of infectivity
identified for scrapie from previous studies and emphasised in the CVMP guidelines of
1993. This was based on a titration of infectivity in mice by the intracerebral route.
8. What consideration if any was given to the risk associated with: (a) the use of bovine
pituitary hormones, both to stimulate ovulation in cattle and otherwise and (b) the
use of ovine materials in veterinary medicines, both in the period before and after
the identification of BSE in cattle?
a. The VPC considered possible contamination of medicines with the BSE agent in July
1988 while assessing guidelines for the review of products containing hormones at the
request of the Medicines Unit. The need for any risk of contamination with BSE to be
considered with substances derived from glandular extracts intended for use in the
treatment of ruminants was highlighted during the discussions concerning hormonal
products in 1988 already referred to (See Paragraph 6 – Chronology of the BSE
discussions at VPC). This discussion included bovine pituitary hormones.
b. The need to avoid the use of ovine brain material, or indeed, any ovine material with the
potential to contaminate medicines with the scrapie agent is dealt with under MAL67 -
MAFF’s 1983 guide to the use of substances of animal origin in the manufacture of
veterinary vaccines [YB83/6.00/1.1-1.4]. As mentioned previously, risk was assessed
with individual product applications. The Committee and I were aware that scrapie had
been disseminated via a louping ill vaccine (I think in the late 1940s or early 1950s) in
which brain and spleen tissue from scrapie-infected sheep had been inadvertently
incorporated.
http://www.bseinquiry.gov.uk/files/ws/s477.pdf
The case of company Z
Whilst the Inquiry revealed some of the secret workings of government,
pharmaceutical companies have been protected by confidentiality clauses
in the 1968 Medicines Act. The Inquiry was warned not to mention their
names—instead the word "redacted" appears in the transcripts.
The Inquiry heard how investigations found there were 111 medicines
administered by injection using the most risky by-products—brain and lymph.
Most were made from imported material, but a range of homeopathic medicines
and surgical sutures were not. The sutures used for sewing up tissues after
operations were manufactured by the main British supplier referred to as "Z".
They were made from cleaned cow intestines that the company processed at the
rate of 2,500 a day. Against the advice of their own guidelines, officials
renewed the licence on condition the company used intestines from clean beef
cattle 18 months to two years old.
A minority recommended the use of intestines from BSE-free countries. The Inquiry
was shown minutes where officials pointed out that “the agreement with the Company
is ‘confidential' so that there will be no direct comparisons” between the
conditions they had set and the recent ban on offals, including intestines,
for human consumption. Four years later, government officials announced that
a study had detected BSE infectivity at the end of the small intestine from
calves as young as six months old.
By July 1992 the BSE Inquiry was told all vaccines available in Britain fully complied
with the guidelines and did not use British cattle by-products. By the end of the same
year 40,000 cattle had shown symptoms of BSE. The number incubating BSE was much larger.
But what of the stocks of vaccines? According to the Daily Telegraph, the BSE Inquiry
has failed to establish what happened to them and “pharmaceutical companies have so far
declined to volunteer the information”. One Inquiry spokesperson said, “It is possible
that we will never know whether all these vaccines were destroyed or whether they were
used.” All the Labour Health Minister, Tessa Jowell would say is they were
“not disposed of or discontinued”. ...end
IATROGENIC DISEASE IN ANIMALS
http://www.iica.org.ar/Bse/6-%20Bradley.html
Ray Bradley
Private BSE Consultant
Veterinary Laboratories Agency, United Kingdom
There have been two reported incidents of iatrogenic disease in animals,
both involving scrapie. One was in Great Britain (Gordon, Brownlee and
Wilson, 1939, Gordon 1946, 1959) the other in Italy (Capucchio et al, 1998,
Agrimi et al, 1999). Both resulted from infection being
introduced into vaccines, louping ill vaccine in Great Britain, Mycoplasma
agalactiae vaccine in Italy. Each of these vaccines was prepared from
tissues that included sheep brain. In both episodes it seems most likely
that natural scrapie infection was present unknowingly in some brains used
for the purpose. Once prepared and having passed all the conventional
vaccine tests large numbers of sheep in Great Britain, and goats and some
sheep in Italy were inoculated. After the necessary incubation period large
numbers (> 1,000 in each case) of inoculated animals came down with scrapie.
In the meantime some inoculated clinically healthy goats and sheep may have
entered food and feed chains or have been used for other purposes. In the
British outbreak there appears to have been no consequence for humans who
may have consumed infected sheep. It is too early to say what may be the
consequences in Italy but measures have been taken to reduce any risk there
may have been. .........end
Louping-ill vaccine documents from November 23rd, 1946 FULL TEXT
THE VETERINARY RECORD
516 No 47. Vol. 58
November 23rd, 1946
NATIONAL VETERINARY MEDICAL ASSOCIATION OF GREAT BRITAIN AND IRELAND
ANNUAL CONGRESS, 1946
The annual Congress, 1946, was held at the Royal Veterinary College,
Royal College Street, London, N.W.I. from September 22nd to September
27th.
Opening Meeting
[skip to scrapie vaccine issue...tss]
Papers Presented to Congress
SNIP...FULL TEXT ;
http://whale.to/v/singeltary.html
although 176 products do _not_ conform to the CSM/VPC
guidelines.
http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf
8. The Secretary of State has a number of licences. We understand that
the inactivated polio vaccine is no longer being used. There is a stock
of smallpox vaccine. We have not been able to determine the source
material. (Made in sheep very unlikely to contain bovine ingredients).
http://www.bseinquiry.gov.uk/files/yb/1989/02/14010001.pdf
http://www.bseinquiry.gov.uk/files/yb/1989/02/14011001.pdf
Draft cover letter to product licence holders
(considered by Human and Vet Medicines including deer)
http://www.bseinquiry.gov.uk/files/yb/1989/02/22008001.pdf
http://www.bseinquiry.gov.uk/files/yb/1989/02/22011001.pdf
2.3.Iatrogenic exposure
Iatrogenic exposure of scrapie has probably occurred twice. The first report determined that
the vehicle was a louping ill vaccine prepared from sheep tissues and this infected a large
number of sheep sheep (Gordon, 1946, Greig, 1950). The second was more recent and in this
case a vaccine against Mycoplasma agalactiae prepared from sheep tissues was incriminated
(Agrimi et al 1999, Capucchio, 1998) but not all outbreaks could be linked to the use of the
vaccine. In this episode goats were predominantly affected10.
http://ec.europa.eu/food/fs/sc/ssc/out170_en.pdf
http://ec.europa.eu/food/fs/sc/ssc/out247_en.pdf
5.3.3 The greatest risk, in theory, would be from parenteral injection of material derived
from bovine brain or lymphoid tissue. Medicinal products for injection or surgical implantation
which are prepared from bovine tissues, or which utilise bovine serum albumin or similar agents
in their manufacture, might also be capable of transmitting infectious agents. All medicinal
products are licensed under the Medicines Act by the Licensing Authority following guidance,
for example from the Committee on Safety of Medicines (CSM), the Committee on Dental and Surgical
Materials (CDSM) and their subcommittees. The Licensing Authority have been alerted to potential
concern about BSE in medicinal products and will ensure that scrutiny of source materials and
manufacturing processes now takes account of BSE agent.
http://www.bseinquiry.gov.uk/files/ib/ibd1/tab02.pdf
The documents below were provided by Terry S. Singeltary Sr on 8 May 2000.
They are optically character read (scanned into computer) and so may contain
typos and unreadable parts.
TIP740203/l 0424 CONFIDENTIAL
Mr Cunningham CMP3 From: D O Hagger MBI
Dr Salisbury MED/IMCD3
Mr Burton PD/STB/PG1B B/17/2 Date: 15.02.1989
Mr Dudley PD/AD4
BOVINE SPONGIFORM ENCEPHALOPATHY
1. The purpose of this minute is to alert you to recent developments on
BSE as they affect medicines and to invite representatives to a meeting
in Market Towers on 22 February 1989.
2. The report of the Working Party on Bovine Spongiform
Encephalopathy (BSE) was submitted by the CMO to the Secretary of State
for Health and Minister for Agriculturer on 9 February.
3. The summary at the end of the report records, inter alia: 'we have
drawn the attention of the Licensing Authority to the potential of
transfer of BSE agent in human and veterinary medicinal products. In
paragraph 7 of his submission (Annex A), the CMO notes:
"I am also putting work urgently in hand to satisfy myself that
everything possible has been done to ensure .... that transfer of the
BSE agent in human and veterinary medicinal products does not occur."
4. The Veterinary products Committee meets on 16 February and The
committee on Safety of Medicines on 23 February when each will be
considering a draft of some joint guidelines for manufacturers of
medicinal products which use bovine material as an ingredient or an
intermediate in the manufacturing process (Annex B).....
6. Although a wide range of medicines may be implicated - and the
present proposal is to write to companies for more information - an
"instant" telephone survey of manufacturer of vaccines used for children
has already been undertaken in response to a request from Dr Harris. The
results are in Dr Adams' minute of 14 February (Annex C) - the proviso
in his second paragraph, last sentence should be noted.
89/02.15/11.1
89/02.15/11.2
MF580439/1 0584
SOUTHWOOD REPORT: BSE AND MEDICINAL PRODUCTS
1. I attach a list of questions on BSE and medicines compiled with the
aim of providing question and answer briefing to DH and MAFF Ministers
upon publication of the Southwood Report. I have suggested names of
those who may be able to provide answers.
All recipients are invited to consider which if any important areas have
been missed. Also attached is copy QA briefing being proposed by MAFF. I
understand MAFF have produced General QA briefing on the reports as a
whole.
..
MF580439/1 0585 Question
1. Which medicines are affected? (person to provide reply) Dr. Jefferys
2. Are the risks greater with some medicines than others? Dr. Jefferys
3. Why are medicines affected? Dr. Jefferys
4. Are some affected products available over the counter from pharmacies or shops? Dr. Purves
5. Are only UK products at risk? Dr. Jefferys
6. Are existing stocks safe? Dr. Jefferys
7. Are pre 1980 stocks available? Mr. Burton
8. Are these alternatives to the use of bovine material? Dr. Purves
9. Why can't we throw away suspect stock and import or manufacture safe medicines? Dr. Jefferys
10. Which patients are at risk? Dr. Jefferys
11. Are some patients particularly vulnerable? Dr Jefferys
12. What risks exist to those who have already used these medicines? Dr. Jefferys
13. HOW might patients be affected? Dr. Jefferys
14. Can BSE be transmitted to patients by medicines? Dr. Jefferys
15. How long will it be before risks are quantified? Dr. Jefferys
100 89/02.17/10.2 MF580439/1 0586
16. What research is going on to find out if medicines can transmit this disease and if any
patients have been affected? Dr Jefferys
17. Could recent cases of Creuuzfeld Jacob Disease have been caused by transmission of BSE through medicines? Dr. Jefferys
18. What action is the Licensing Authority taking to ensure proper scrutinising of source materials and manufacturing processes? Dr. Jefferys/Dr. Purves
19. Are the guidelines practical? Dr. Jefferys/Dr. Purves
20. Will the guidelines remove the risk? Dr. Jefferys
21. How will the guidelines be enforced? Dr. Jefferys/Dr. Purves
22. How soon will they come into force? Dr. Jefferys
23. Will the guidelines be published? Mr. Hagger
24. What is being done to reassure patients, parents etc? Mr. Hagger/Dr. Salisbury
25. What advice is being given to doctors, pharmacists etc? Mr. Hagger
26. What advice is the Government giving about its vaccination programme? Dr. Salisbury
27. Is the vaccination programme put at risk because of BSE? Dr. Salisbury
89/02.17/10.3
Q. Will government act on this?
A. Yes - thymus is not used in preparation of baby foods but it is
contacting all manufacturers to seek their urgent views on use of
kidneys and liver from ruminants. Will consider any necessary measures
in the light of their response.
VETERINARY MEDICINES
Q. Can medicines spread BSE to other cattle/animals?
A. The report describes any risks as remote.
Q. How can risks be avoided?
A. In liaison with the DOH the Veterinary Products Committee is
examining guidelines for the veterinary pharmaceutical industry
which will be issued shortly.
Q. What will Guidelines say?
A. In essence they call for non-bovine sources to be used if possible,
including synthetic material of biotechnological origin. Where this is
not possible the industry should look for sources which are free of BSE
and which are collected in a manner which avoids risk of contamination
by the BSE agent.
89/02.17/10.4 MF580439/1 0588
A. Bovine source material is used in [garbled, cannot read...TSS] and some other medicines.
Q. How many medicines are involved?
A. Computer records show that about 300 of the 3,050 veterinary
medicines licensed in the U.K. are manufactured directly from bovine
source material. However, other medicines may be produced from
bovine sources and a letter is going to all license holders so that a
comprehensive list can be drawn up.
89/06.19/8.1 BSE3/1 0191 Hr J Maslin (MAFF) Ref: Maslin3g
From: Dr H Pickles Med SEB/B Date: 3 July 1989
CATTLE BY-PRODUCTS AND BSE
I was interested to see the list of by-products sent to the HSE. Those
of particular concern included:
* small intestines: sutures (I thought the source was ovine but you are
checking this)
* spinal cord: pharmaceuticals
* thymus: pharmaceuticals
Are you able to give me more information on which UK manufacturers use
these materials? Our proposed ban on bovine offal for human consumption
would not affect these uses, I assume.
Id No. 1934/RD/1 89/08.10/6.1 117A
BOVINE SPONGIFORM ENCEPHALAPATHY MEETING
HELD ON 21 AUGUST 1989 AT 2;15 IN ROOM 720
Miss M Duncan (Chairman)
Mr W Burton
Dr E Hoxey
Mrs J Dhell
Ms K Turner
Dr S Whittle
Mr N Weatherhead
...
5. The MCA had sent 2700 questionnaires out, 1,124 had made valid
returns; of these 122 use animal material of some kind and there are 582
products involved.
...
6. The MCA/BSE working group will meet on 6th September. Their
aim is to review responses from professional officers in MCA who have
suggested seven categories of importance (with 1 being the most
important} for medical products:
ID 2267/NRE/1 89/08.21/10.1
1. Products with Bovine brain/lymph tissue administered by injection.
2. Products with bovine tissue other than brain/lymph administered by
inection.
3. Tissue implants/open wound dressing/surgical materials/dental and
ophthlamic products with bovine ingredients.
4. Products with bovine ingredients administered topically.
5. Products with bovine ingredients administered orally.
6. Products with other animal/fish/insect/bird ingredients administered
by injection/topically/oral routes.
7. Products with ingredients derived from animal material by chemical
processing (eg stearic acid, gelatine, lanolin ext.
The BSE working group will decide which of these are important, and
should be examined more closely, and which categories can be eliminated.
The responses by the companies were presented by Ms Turner and were
categorised by MCA standards, the products that were discussed were all
low volume usage products eg sutures, heart valves.
8. As the responses included some materials of human origin it
was decided that more information should be sought about CJD. There had
been 2 recent deaths reported associated with human growth hormone.
These were being investigated.
9. Re-editing of the Paper on "Incubation of Scrapie-like Agents"
It was suggested that the document could be sent out to companies with
the non-standard sterilization Document. The document could have severe
implications on the companies whose products have a high risk factor as
decided by the MCA working group....
11. The Need for a list of High Priority Implantables The commitee decided that no list is
necessary as all implantables, including ones from a human source are of high priority. Concern was
shown over Killingbeck who use human material but had not yet responded.
The company will be chased for a response. Concern was shown over the fact that there may be other scrapie-like
organisms in other animals and further enquiries should be made.
2334q/RD/4 89/08.21/10.7
BOVINE MATERIAL USED IN THE MANUFACTURE OF SURGICAL IMPLANTS AND
BLOOD CONTACT MEDICAL DEVICES
Glutaraldehyde, formaldehyde, and ethylene oxide are used in the
sterilization of these devices.
However, glutaraldehyde 4,10,12,19 formaldehyde 5,10,11,13,19 and
ethylene oxide 19,23 are all reported to be ineffective methods for
sterilization of material infected with the agents of CJD or scrapie.
Previous advice and research using the agents of CJD and scrapie, has
concentrated on the decontamination of equipment; protection of health
care workers from contaminated human material; human growth hormone; and
dura mater. The methods developed may not be directly applicable or
transferable to material of bovine origin for use in human implantation.
2334q/RD/7 89/08.21/10.10 BSE11/2 020 SC1337
DEPARTMENT OF HEALTH AND SOCIAL SECURITY
Richmood House 79 Whitehall, London SW1A 2NS
Telephone 01-210-3000
From the Chief Medical Officer
Sir Donald Acheson KBE DM DSc FRCP FFCM FFOM
Mr K C Meldrum
Chief Veterinary Officer
Ministry of Agriculture, Fisheries and Food
Government Buildings
Hook Rise South
Tolworth
Surbiton
Surrey
KT6 7NG
3 January 1990
Dear Mr. Meldrum,
BOVINE SPONGIFORM ENCEPHALOPATHY
You will recall that we have previously discussed the potential risks of
BSE occurring in other Countries as a result of the continuing export
from the UK of meat and bone that may be contaminated by scrapie or
possibly BSE.
I remain concerned that we are not being consistent in our attempts to
contain the risks of BSE. Having banned the feeding of meat and bone
meal to ruminants in 1988, we should take steps to prevent these UK
products being fed to ruminants in other countries. This could be
achieved either through a ban on the export of meat and bone meal, or at
least by the proper labelling of these products to make it absolutely
clear they should not be fed to ruminants. Unless some such action is
taken the difficult problems we have faced with BSE may well occur in
other countries who import UK meat and bone meal. Surely it is short
sighted for us to risk being seen in future as having been responsible
for the introduction of BSE to the food chain in other countries.
I would be very interested to hear how you feel this gap in the present
prcautionary measures to eliminate BSE should be closed. We should be
aiming at the global elimination of this new bovine disease. The export
of our meat and bone meal is a continuing risk to other countries.
Signed
Sincerely Donald Acheson
Did the US import fetal calf serum and vaccines from BSE-affected countries?
3002.10.0040: FETAL BOVINE SERUM (FBS)
U.S. Imports for Consumption: December 1998 and 1998 Year-to-Date
(Customs Value, in Thousands of Dollars)
(Units of Quantity: Kilograms)
<--- Dec 1998 ---> <--- 1998 YTD --->
Country Quantity Value Quantity Value
=================================================================
WORLD TOTAL . . . . . . . 2,727 233 131,486 8,502
Australia . . . . . . . . --- --- 19,637 2,623
Austria . . . . . . . . . --- --- 2,400 191
Belgium . . . . . . . . . --- --- 17 32
Canada . . . . . . . . . 900 110 30,983 3,220
Costa Rica . . . . . . . 500 20 4,677 169
Federal Rep. of Germany --- --- 105 21
Finland . . . . . . . . . 1 8 9 83
France . . . . . . . . . --- --- 73 7
Guatemala . . . . . . . . --- --- 719 42
Honduras . . . . . . . . --- --- 1,108 88
Israel . . . . . . . . . --- --- 24 165
Netherlands . . . . . . . --- --- 1 5
New Zealand . . . . . . . 26 5 65,953 913
Panama . . . . . . . . . --- --- 1,195 64
Switzerland . . . . . . . 971 8 1,078 23
United Kingdom . . . . . 329 82 743 756
Uruguay . . . . . . . . . --- --- 2,764 98
------------------------------------------------------------------
3002.20.0000: VACCINES FOR HUMAN MEDICINE
U.S. Imports for Consumption: December 1998 and 1998 Year-to-Date
(Customs Value, in Thousands of Dollars)
(Units of Quantity: Kilograms)
<--- Dec 1998 ---> <--- 1998 YTD --->
Country Quantity Value Quantity Value
=================================================================
WORLD TOTAL . . . . . . . 25,702 26,150 550,258 378,735
Austria . . . . . . . . . --- --- 45 225
Belgium . . . . . . . . . 14,311 12,029 248,041 199,036
Canada . . . . . . . . . 1,109 1,527 15,798 16,305
Denmark . . . . . . . . . 80 234 246 682
Federal Rep. of Germany 1,064 4,073 12,001 6,329
France . . . . . . . . . 3,902 4,859 87,879 92,845
Ireland . . . . . . . . . --- --- 120 478
Italy . . . . . . . . . . --- --- 2,359 81
Japan . . . . . . . . . . 445 1,903 11,350 11,298
Netherlands . . . . . . . --- --- 94 6
Republic Of South Africa --- --- 2 1
Spain . . . . . . . . . . --- --- 60 30
Switzerland . . . . . . . 716 353 9,303 4,271
United Kingdom . . . . . 4,075 1,172 162,960 47,148
------------------------------------------------------------------
3002.30.0000: VACCINES FOR VETRINARY MEDICINE
U.S. Imports for Consumption: December 1998 and 1998 Year-to-Date
(Customs Value, in Thousands of Dollars)
(Units of Quantity: Kilograms)
<--- Dec 1998 ---> <--- 1998 YTD --->
Country Quantity Value Quantity Value
=================================================================
WORLD TOTAL . . . . . . . 6,528 237 87,149 2,715
Canada . . . . . . . . . --- --- 2,637 305
Federal Rep. of Germany --- --- 104 5
Netherlands . . . . . . . 138 64 472 192
New Zealand . . . . . . . 6,390 173 83,882 1,895
United Kingdom . . . . . --- --- 54 318
http://www.mad-cow.org/00/may00_news.html
SEE HEART VALVES ;
http://www.mad-cow.org/00/may00_news.html#aaa
My submission to FDA about this ;
http://www.fda.gov/ohrms/dockets/dailys/00/mar00/030100/emc0597.rtf
http://www.fda.gov/OHRMS/DOCKETS/DOCKETS/96n0417/96N-0417-EC-2.htm
PDF]Freas, William TSS SUBMISSION
File Format: PDF/Adobe Acrobat -
Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary
Sr. [flounder [at] wt.net] Monday, January 08,200l 3:03 PM freas ...
http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf
Asante/Collinge et al, that BSE transmission to the 129-methionine
genotype can lead to an alternate phenotype that is indistinguishable
from type 2 PrPSc, the commonest _sporadic_ CJD;
http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm
Date: Sun, 7 Jan 2001 09:45:19 -0800
Reply-To: Sustainable Agriculture Network Discussion Group
<[log in to unmask]>
Sender: Sustainable Agriculture Network Discussion Group
<[log in to unmask]>
From: Beth von Gunten <[log in to unmask]>
Subject: [BSE] FDA/IMPORTANT NOTICE: 50 STATE CONFERENCE CALL
Content-Type: text/plain; charset="us-ascii" ; format="flowed"
IMPORTANT NOTICE: 50 STATE CONFERENCE CALL - BSE
TUESDAY, JANUARY 9, 2001
1:00-2:00 PM EST CALL: 1-888-273-9887
A special "50 STATE CONFERENCE CALL" to discuss BSE (Bovine
Spongiform Encephalopathy) issues for Food and Drug Administration
(FDA) regulated animal feed products in the United States and
imported animal feeds. The conference call will
discuss the FDA proposed response to the current BSE issue and the
assistance needed from state feed and agriculture programs. THIS
ISSUE MAY IMPACT ALL STATES AND ALL ANIMAL FEED AND PRODUCTION
INDUSTRIES.
The 50 State call is scheduled for Tuesday, January 9, 2001 from
1:00-2:00 pm EST. Any state agency responsible for animal feed issues
wishing to participate should call 1-888-273-9887 and ask to be
connected to the "50 State BSE Call". The conference host operator
will explain how to participate, including asking questions during
the call. If possible, please coordinate within your state to utilize
only one phone line per state agency.
We request that you forward this message to your agency management
and feed coordinators or other agencies or departments who may be
responsible for any animal feed issues related to FDA regulated
products.
The agenda will be as follows:
1. Center For Veterinary Medicine (FDA) - Discussion of the problem
related to BSE events in Europe and the impact on US feed ingredients
for animals and feed operations. Discussion of the proposed
actions/inspections/compliance of licensed and unlicensed feed mills,
commercial feed manufacturers, animal feed imports, renderer's,
protein blenders, on-farm mixers, and ruminant feeders.
2. Office of Regional Operations (FDA) - Discussion of
contracting/working with states to inspect the universe of feed
mills/industry for "Animal Proteins Prohibited from Use in Animal
Feed". Discussion of working with FDA field offices.
3. Questions and answers.
Richard H. Barnes, Director
Division of Federal-State Relations (HFC-150)
5600 Fishers Lane Room 1207
Rockville, Md. 20857
ph: (301) 827-6906 FAX: (301) 443-2143
Email: [log in to unmask]
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0101&L=sanet-mg&P=13410
Subject: U.S.A. - 50 STATE BSE CONFERENCE CALL JAN. 9, 2001 (my notes)
Date: January 10, 2001 at 1:36 pm PST
Subject: BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001
Date: Tue, 9 Jan 2001 16:49:00 -0800
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L [at] uni-karlsruhe.de
######### Bovine Spongiform Encephalopathy #########
Greetings List Members,
I was lucky enough to sit in on this BSE conference
call today and even managed to ask a question.
that is when the trouble started.
I submitted a version of my notes to
Sandra Blakeslee of the New York Times,
whom seemed very upset, and rightly
so.
"They tell me it is a closed meeting and
they will release whatever information
they deem fit. Rather infuriating."
and i would have been doing just fine,
until i asked my question. i was surprised
my time to ask a question so quick.
(understand, these are taken from my notes for now.
the spelling of names and such could be off.)
[host Richard Barns]
and now a question from Terry S. Singeltary of
CJD Watch.
[TSS]
yes, thank you,
U.S. cattle, what kind of guarantee can you
give for serum or tissue donor herds?
[no answer, you could hear in the back ground,
mumbling and 'we can't. have him ask the question
again.]
[host Richard]
could you repeat the question?
[TSS]
U.S. cattle, what kind of guarantee can you
give for serum or tissue donor herds?
[not sure whom ask this]
what group are you with?
[TSS]
CJD Watch, my Mom died from hvCJD and we are
tracking CJD world-wide.
[not sure who is speaking]
could you please disconnect Mr. Singeltary
[TSS]
you are not going to answer my question?
[not sure whom speaking]
NO
from this point, i was still connected, got to listen
and tape the whole conference. at one point someone
came on, a woman, and ask again;
[unknown woman]
what group are you with?
[TSS]
CJD Watch and my Mom died from hvCJD
we are trying to tract down CJD and other
human TSE's world wide. i was invited to
sit in on this from someone inside the USDA/APHIS
and that is why i am here. do you intend on banning
me from this conference now?
at this point the conference was turned back up,
and i got to finish listening. They never answered
or even addressed my one question, or even addressed
the issue. BUT, i will try and give you a run-down
for now, of the conference.
IF i were another Country, I would take heed to my
notes, BUT PLEASE do not depend on them. ask for
transcript from;
RBARNS [at] ORA.FDA.GOV
301-827-6906
he would be glad to give you one ;-)
Rockville Maryland,
Richard Barns Host
BSE issues in the U.S.,
How they were labelling ruminant feed?
Revising issues.
The conference opened up with the explaining of
the U.K. BSE epidemic winding down with about 30
cases a week.
although new cases in other countries were now
appearing.
Look at Germany whom said NO BSE and now have BSE.
BSE increasing across Europe.
Because of Temporary Ban on certain rendered product,
heightened interest in U.S.
A recent statement in Washington Post, said the
New Administration (old GW) has a list of issues.
BSE is one of the issues.
BSE Risk is still low, minimal in U.S. with a greater
interest in MBM not to enter U.S.
HOWEVER, if BSE were to enter the U.S.
it would be economically disastrous
to the render, feed, cattle, industries,
and for human health.
(human health-they just threw that in cause i was listening.
I will now jot down some figures in
which they told you, 'no need to write them down'.
just hope i have them correct. hmmm, maybe i hope
i don't ???)
80% inspection of rendering
*Problem-Complete coverage of rendering HAS NOT
occurred.
sizeable number of 1st time FAILED INITIAL INSPECTION,
have not been reinspected (70% to 80%).
Compliance critical, Compliance poor in U.K.
and other European Firms.
Gloria Dunason
Major Assignment 1998 goal TOTAL compliance.
This _did not_ occur. Mixed level of compliance,
depending on firm.
Rendering FDA license and NON FDA license
system in place for home rendering & feed
76% in compliance
79% cross contamination
21% DID NOT have system
92% record keeping
less than 60% total compliance
279 inspectors
185 handling prohibited materials
Renderer at top of pyramid, significant
part of compliance.
84% compliance
failed to have caution statement render
72% compliance & cross contamination
caution statement on feed, 'DO NOT FEED TO CATTLE'
56 FIRMS NEVER INSPECTED
1240 FDA license feed mills
846 inspected
"close to 400 feed mills have not been inspected"
80% compliance for feed.
10% don't have system.
NON-FDA licensed mills
There is NO inventory on non licensed mills.
approximately 6000 to 8000 Firms ???
4,344 ever inspected.
"FDA does not have a lot of experience with"
40% do NOT have caution statement 'DO NOT FEED'.
74% Commingling compliance
"This industry needs a lot of work and only half
gotten to"
"700 Firms that were falitive, and need to be
re-inspected, in addition to the 8,000 Firms."
Quote to do BSE inspection in 19 states by end
of January or 30 days, and other states 60 days.
to change feed status??? Contract check and ask
questions and pass info.
At this time, we will take questions.
[I was about the third or fourth to ask question.
then all B.S.eee broke loose, and i lost my train
of thought for a few minutes. picked back up here]
someone asking about nutritional supplements and
sourcing, did not get name. something about inspectors
not knowing of BSE risk??? the conference person assuring that Steve
Follum? and the TSE advisory Committee were
handling that.
Some other Dr. Vet, whom were asking questions
that did not know what to do???
[Dennis Wilson]
California Food Agr.
Imports, are they looking at imports?
[Conference person]
they are looking at imports,
FDA issued imports Bulletin.
[Linda Singeltary ??? this was a another phone in
question, not related i don't think]
Why do we have non-licensed facilities?
(conference person)
other feed mills do not handle as potent drugs???
Dennis Blank, Ken Jackson
licensed 400
non FDA 4400 inspected of a total of 6000 to 8000,
(they really don't know how many non licensed Firms
in U.S. they guess 6000 to 8000??? TSS)
Linda Detwiler
asking everyone (me) not to use emergency BSE number,
unless last resort.
(i thought of calling them today, and reporting the
whole damn U.S. cattle herd ;-) 'not'
Warren-Maryland Dept. Agr.
Prudent to re-inspect after 3 years.
concerned of Firms that have changed
owners.
THE END
TSS
############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ############
JANUARY 9, 2001 50 STATE BSE CONFERENCE CALL
http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html
http://www.fda.gov/OHRMS/DOCKETS/DOCKETS/96n0417/96N-0417-EC-2.htm
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0612&L=sanet-mg&D=0&T=0&P=1049
http://www.bioedonline.org/forums/messageview.cfm?thread=954
http://lists.iatp.org/listarchive/archive.cfm?id=121143
ALL the warnings have been there, most just chose to ignore them, now only time will tell who has to pay the final price.
sadly, some like Lester Crawford reaped the rewards of ignoring these risk factors $$$ you cannot put the wolf in guard
of the hen house, and the fda, usda, aphis, fsis, et al are full of these wolves guarding the hen houses ;
Sentencing Is Delayed in Case Of Former FDA Commissioner
ASSOCIATED PRESS
Former FDA Commissioner Lester Crawford's sentencing on charges he lied about his stock holdings was delayed Tuesday over
questions about sentencing guidelines. Under a deal worked out between his attorney and federal prosecutors, Mr. Crawford had
agreed earlier to a $50,000 fine and probation. Magistrate Judge Deborah A. Robinson asked the attorneys to explain why they didn't
use certain federal sentencing guidelines in ... snip...end
http://online.wsj.com/
no conflict of interest there right ???
WHAT else did old lester crawford lie about, and whom reaped what from that $$$
Press Release
FOR IMMEDIATE RELEASE
Monday, Jan. 26, 2004
FDA Press Office
301-827-6242
Expanded "Mad Cow" Safeguards Announced to Strengthen Existing Firewalls Against BSE Transmission
HHS Secretary Tommy G. Thompson today announced several new public health measures, to be implemented by the Food and
Drug Administration (FDA), to strengthen significantly the multiple existing firewalls that protect Americans from exposure to the agent
thought to cause bovine spongiform encephalopathy (BSE, also known as mad cow disease) and that help prevent the spread of BSE in U.S. cattle.
The existing multiple firewalls, developed by both the U.S. Department of Agriculture (USDA) and HHS, have been extremely effective in protecting
the American consumer from exposure to BSE. The first firewall is based on import controls started in 1989. A second firewall is surveillance of the
U.S. cattle population for the presence of BSE, a USDA firewall that led to the finding of the BSE cow in December. The third firewall is FDA's 1997
animal feed ban, which is the critical safeguard to help prevent the spread of BSE through cattle herds by prohibiting the feeding of most mammalian
protein to ruminant animals, including cattle. The fourth firewall, recently announced by USDA, makes sure that no bovine tissues known to be at high
risk for carrying the agent of BSE enter the human food supply regulated by USDA. The fifth firewall is effective response planning to contain the
potential for any damage from a BSE positive animal, if one is discovered. This contingency response plan, which had been developed over the past
several years, was initiated immediately upon the discovery of a BSE positive cow in Washington State December 23.
The new safeguards being announced today are science-based and further bolster these already effective safeguards.
Specifically, HHS intends to ban from human food (including dietary supplements), and cosmetics a wide range of bovine-derived material so that the
same safeguards that protect Americans from exposure to the agent of BSE through meat products regulated by USDA also apply to food products that
FDA regulates.
FDA will also prohibit certain currently allowed feeding and manufacturing practices involving feed for cattle and other ruminant animals. These additional
measures will further strengthen FDA's 1997 "animal feed" rule.
"Today's actions will make strong public health protections against BSE even stronger," Secretary Thompson said. "Although the current animal feed
rule provides a strong barrier against the further spread of BSE, we must never be satisfied with the status quo where the health and safety of our
animals and our population is at stake. The science and our own experience and knowledge in this area are constantly evolving. Small as the risk
may already be, this is the time to make sure the public is protected to the greatest extent possible."
"Today we are bolstering our BSE firewalls to protect the public," said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "We are further strengthening
our animal feed rule, and we are taking additional steps to further protect the public from being exposed to any potentially risky materials from cattle.
FDA's vigorous inspection and enforcement program has helped us achieve a compliance rate of more than 99 percent with the feed ban rule, and we
intend to increase our enforcement efforts to assure compliance with our enhanced regulations. Finally, we are continuing to assist in the development
of new technologies that will help us in the future improve even further these BSE protections. With today's actions, FDA will be doing more than ever
before to protect the public against BSE by eliminating additional potential sources of BSE exposure."
To implement these new protections, FDA will publish two interim final rules that will take effect immediately upon publication, although there will be an
opportunity for public comment after publication.
The first interim final rule will ban the following materials from FDA-regulated human food, (including dietary supplements) and cosmetics:
Any material from "downer" cattle. ("Downer" cattle are animals that cannot walk.)
Any material from "dead" cattle. ("Dead" cattle are cattle that die on the farm (i.e. before reaching the slaughter plant);
Specified Risk Materials (SRMs) that are known to harbor the highest concentrations of the infectious agent for BSE, such as the brain,
skull, eyes, and spinal cord of cattle 30 months or older, and a portion of the small intestine and tonsils from all cattle, regardless of their age or health;
and
The product known as mechanically separated beef, a product which may contain SRMs. Meat obtained by Advanced Meat Recovery (an
automated system for cutting meat from bones), may be used since USDA regulations do not allow the presence of SRMs in this product.
The second interim final rule is designed to lower even further the risk that cattle will be purposefully or inadvertently fed prohibited protein. It was the
feeding of such protein to cattle that was the route of disease transmission that led to the BSE epidemic in United Kingdom cattle in the 1980's and 1990's.
This interim final rule will implement four specific changes in FDA's present animal feed rule. First, the rule will eliminate the present exemption in the feed
rule that allows mammalian blood and blood products to be fed to other ruminants as a protein source. Recent scientific evidence suggests that blood can
carry some infectivity for BSE.
Second, the rule will also ban the use of "poultry litter" as a feed ingredient for ruminant animals. Poultry litter consists of bedding, spilled feed, feathers,
and fecal matter that are collected from living quarters where poultry is raised. This material is then used in cattle feed in some areas of the country where
cattle and large poultry raising operations are located near each other. Poultry feed may legally contain protein that is prohibited in ruminant feed, such as
bovine meat and bone meal. The concern is that spillage of poultry feed in the chicken house occurs and that poultry feed (which may contain protein
prohibited in ruminant feed) is then collected as part of the "poultry litter" and added to ruminant feed.
Third, the rule will ban the use of "plate waste" as a feed ingredient for ruminants. Plate waste consists of uneaten meat and other meat scraps that are
currently collected from some large restaurant operations and rendered into meat and bone meal for animal feed. The use of "plate waste" confounds
FDA's ability to analyze ruminant feeds for the presence of prohibited proteins, compromising the Agency's ability to fully enforce the animal feed rule.
Fourth, the rule will further minimize the possibility of cross-contamination of ruminant and non-ruminant animal feed by requiring equipment, facilities or
production lines to be dedicated to non-ruminant animal feeds if they use protein that is prohibited in ruminant feed. Currently, some equipment, facilities
and production lines process or handle prohibited and non-prohibited materials and make both ruminant and non-ruminant feed -- a practice which could
lead to cross-contamination.
To accompany these new measures designed to provide a further layer of protection against BSE, FDA will in 2004 step up its inspections of feed mills
and renderers. FDA will itself conduct 2,800 inspections and will make its resources go even further by continuing to work with state agencies to fund 3,100
contract inspections of feed mill and renderers and other firms that handle animal feed and feed ingredients. Through partnerships with states, FDA will also
receive data on 700 additional inspections, for a total of 3,800 state contract and partnership inspections in 2004 alone, including annual inspections of 100
percent of all known renderers and feed mills that process products containing materials prohibited in ruminant feed.
"We have worked hard with the rendering and animal feed production industries to try and achieve full compliance with the animal feed rule," said Dr. McClellan,
"and through strong education and a vigorous enforcement campaign, backed by additional inspections and resources, we intend to maintain a high level of compliance."
Dr. McClellan also noted that, in response to finding a BSE positive cow in Washington state December 23, FDA inspected and traced products at 22 facilities related
to that positive cow or products from the cow, including feed mills, farms, dairy farms, calf feeder lots, slaughter houses, meat processors, transfer stations, and
shipping terminals. Moreover, FDA has conducted inspections at the rendering facilities that handled materials from the positive cow, and they were found to be
fully in compliance with FDA's feed rule.
To further strengthen protections for Americans, FDA/HHS intends to work with Congress to consider proposals to assure that these important protective measures
will be implemented as effectively as possible.
FDA is also continuing its efforts to assist in the development of better BSE science, to achieve the same or greater confidence in BSE protection at a lower cost.
For example, to enhance the ability of our public health system to detect prohibited materials in animal feed, FDA will continue to support the development and
evaluation of diagnostic tests to identify prohibited materials. These tests would offer a quick and reliable method of testing animal feeds for prohibited materials
and for testing other products for contamination with the agent thought to cause BSE.
FDA has publicly discussed many of the measures being announced today with stakeholders in workshops, videoconferences, and public meetings. In addition,
FDA published an Advance Notice of Proposed Rulemaking in November 2002 (available online at http://www.fda.gov/OHRMS/DOCKETS/98fr/110602c.htm
concerning possible changes to the animal feed rule.
Comprehensive information about FDA's work on BSE and links to other related websites are available at http://www.fda.gov.
###
http://www.fda.gov/bbs/topics/news/2004/hhs_012604.html
STATEMENT
BY
LESTER M. CRAWFORD, D.V.M., PH.D.
DEPUTY COMMISSIONER OF FOOD AND DRUGS
DEPARTMENT OF HEALTH AND HUMAN SERVICES
BEFORE
THE COMMITTEE ON AGRICULTURE, NUTRITION, AND FORESTRY
UNITED STATES SENATE
JANUARY 27, 2004
Introduction
Mr. Chairman, Members of the Committee, thank you for the opportunity to participate in today’s hearing on measures taken by the Federal government to
safeguard human and animal health in the United States from Bovine Spongiform Encephalopathy (BSE) and the response to the finding of a BSE-positive
cow in the State of Washington. I am Dr. Lester M. Crawford, Deputy Commissioner, Food and Drug Administration (FDA or the Agency).
The mission of FDA is to protect the public health by assuring the safety and efficacy of our nation’s human and veterinary drugs, human biological products,
medical devices, human and animal food supply, cosmetics, and radiation emitting products. In fulfilling this mission, FDA is the Agency responsible for
assuring that all FDA-regulated products remain safe and uncompromised from BSE and related diseases. Many FDA-regulated products contain bovine
ingredients, for example, heart valves, ophthalmic devices, dental products, wound dressings, injectable drugs, vaccines, soups, gravies, sausage casings,
and animal feeds.
FDA has long been actively involved nationally and internationally in efforts to understand and prevent the spread of BSE. FDA collaborates extensively with
the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the Animal and Plant Health Inspection Service (APHIS) and
the Food Safety and Inspection Service (FSIS) within the U.S. Department of Agriculture (USDA), Customs and Border Protection (CBP), the Environmental
Protection Agency (EPA), other Federal agencies, state and local jurisdictions, and with affected industries and consumer groups. Many of these activi
For more information:
http://www.neurology.org/cgi/eletters/60/2...
STATEMENT
BY
LESTER M. CRAWFORD, D.V.M., PH.D.
DEPUTY COMMISSIONER OF FOOD AND DRUGS
DEPARTMENT OF HEALTH AND HUMAN SERVICES
BEFORE
THE COMMITTEE ON AGRICULTURE, NUTRITION, AND FORESTRY
UNITED STATES SENATE
JANUARY 27, 2004
Introduction
Mr. Chairman, Members of the Committee, thank you for the opportunity to participate in today’s hearing on measures taken by the Federal government to
safeguard human and animal health in the United States from Bovine Spongiform Encephalopathy (BSE) and the response to the finding of a BSE-positive
cow in the State of Washington. I am Dr. Lester M. Crawford, Deputy Commissioner, Food and Drug Administration (FDA or the Agency).
The mission of FDA is to protect the public health by assuring the safety and efficacy of our nation’s human and veterinary drugs, human biological products,
medical devices, human and animal food supply, cosmetics, and radiation emitting products. In fulfilling this mission, FDA is the Agency responsible for
assuring that all FDA-regulated products remain safe and uncompromised from BSE and related diseases. Many FDA-regulated products contain bovine
ingredients, for example, heart valves, ophthalmic devices, dental products, wound dressings, injectable drugs, vaccines, soups, gravies, sausage casings,
and animal feeds.
FDA has long been actively involved nationally and internationally in efforts to understand and prevent the spread of BSE. FDA collaborates extensively with
the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the Animal and Plant Health Inspection Service (APHIS) and
the Food Safety and Inspection Service (FSIS) within the U.S. Department of Agriculture (USDA), Customs and Border Protection (CBP), the Environmental
Protection Agency (EPA), other Federal agencies, state and local jurisdictions, and with affected industries and consumer groups. Many of these activities
fit within the framework of the Department of Health and Human Service’s (HHS or the Department) Bovine Spongiform Encephalopathy/Transmissible
Spongiform Encephalopathy (BSE/TSE) Action Plan, which was released in August 2001. This collaboration over many years has enabled FDA to strengthen
safeguards for FDA-regulated products and to respond quickly and effectively to the first case of BSE within the U.S.
Executive Summary
The mission of the Agency is to protect the public health by assuring the safety and efficacy of our nation’s human and veterinary drugs, human biological
products, medical devices, human and animal food supply, cosmetics, and radiation emitting products. In fulfilling this mission, FDA is the Agency
responsible for assuring that all FDA-regulated products remain safe and uncompromised from BSE and related diseases.
BSE is a progressive neurological disorder of cattle that results from infection by an unconventional transmissible agent, and was first diagnosed in the
United Kingdom (U.K.) in 1986. Many FDA-regulated products contain bovine ingredients, for example, heart valves, ophthalmic devices, dental products,
wound dressings, injectable drugs, vaccines, soups, gravies, sausage casings, and animal feeds and thus must be taken into consideration as part the
effort to prevent infectivity by BSE.
FDA has a longstanding commitment to protecting consumers from BSE by following multiple measures designed to safeguard FDA-regulated products
from possible contamination by the BSE agent. Under the Federal Food, Drug, and Cosmetic (FD&C) Act, FDA has the authority to prevent the adulteration
and misbranding of FDA-regulated products. Further, for medical products that require pre-market approval (e.g., drugs under Section 505 and medical
devices under Section 513 of the FD&C Act), FDA has addressed safety concerns related to BSE through requirements of the application and approval
process.
The U.S. employs a robust multi-layered approach to preventing the introduction and amplification of BSE. While the goal of this approach is to achieve
an extremely high level of compliance with each preventative measure, this multi-layered approach is designed to protect the U.S. consumer from exposure
to the BSE infective material, and to date this approach has been working. Since 1989, USDA has prohibited the importation of live animals and animal
products from BSE-positive countries. Since 1997, FDA has prohibited the use of certain mammalian proteins in the manufacture of ruminant feed. FDA
continues to implement policies to keep safe all FDA-regulated products, including food, food ingredients, dietary supplements, drugs, vaccines, and
cosmetics from risk of any BSE-contaminated bovine material. As a result of these multiple regulatory safeguards, the risk of exposure to BSE through
products, FDA regulates remains extremely low in the U.S.
FDA’s 1997 animal feed regulation forms the basis of the Agency’s efforts to prevent the spread of BSE through animal feed. This rule prohibits the use
of most mammalian protein in the manufacture of animal feeds for ruminants. FDA implemented this rule to establish in our country feeding practices
consistent with the best science and epidemiological knowledge known at the time to prevent the spread of BSE throughout herds of U.S. cattle. A risk
assessment sponsored by USDA and conducted by the Harvard Center for Risk Analysis, released in November 2001, identified FDA’s feed ban as one
of the primary safeguards against the spread of BSE in U.S. cattle.
To maximize protection afforded by the feed regulation, FDA has developed and implemented a BSE/Ruminant Feed Ban Inspection compliance program
and established the goal of 100 percent compliance. FDA’s strategy for achieving uniform compliance with the feed rule focuses on three areas: education,
inspection, and enforcement. FDA and its state counterparts conduct, at least annually, targeted BSE inspections of 100 percent of known renderers,
protein blenders, and feed mills processing products containing material prohibited from use in ruminant feed. Compliance by these establishments
with FDA’s feed rule is estimated to be at better than 99 percent. As of December 20, 2003, FDA had received over 26,000 inspection reports
(6,404 for Fiscal Year 2003). The majority of these inspections (around 70 percent) were conducted by state officials for FDA, with the remainder conducted
by FDA officials. The total number of inspection reports represents 13,672 firms, 1,949 of which are active and handle materials prohibited from use in
ruminant feed. The 1,949 active firms that handle prohibited material have been inspected by FDA and, as of December 31, 2003, only five were found to
have significant violations, resulting in official action indicated (OAI). FDA is working with these firms to bring them into compliance.
On December 23, 2003, FDA was notified by USDA of a presumptive-positive finding of BSE in a cow in Washington State. FDA immediately initiated its BSE
Emergency Response Plan. As part of the plan, FDA has been coordinately closely with USDA so that we can effectively investigate this BSE case, trace the
various products involved, and take the appropriate steps to protect the public. FDA investigators and inspectors located the high risk material rendered
from the infected cow, and the rendering plants placed a hold on the rendered material, which is being disposed of appropriately. I am happy to report that
all of the establishments inspected by FDA during the course of the investigation were in compliance with the feed ban. In addition, to help address the
concerns of foreign governments and restore confidence in American products, FDA has participated, along with USDA, in numerous meetings and
consultations with foreign governments since USDA surveillance found the BSE-positive cow.
In addition to new policies and regulations, new knowledge and tools gained through applied research can greatly help us to be more effective in our
regulatory mission, such as protecting the country from BSE. Several of FDA’s Centers, as well as many private laboratories, academic institutions, and
other Federal agencies (most notably NIH) are also involved in significant research activities relating to TSEs. Basic areas requiring research include:
increasing our understanding of prions, learning how prions are transmitted within a species and potentially between species, developing diagnostic
tests for humans and animals, developing detection methods for use on regulated products, developing methods to increase or eliminate infectivity,
and designing new treatments. We are optimistic about the promise of new technologies, such as better methods to quickly distinguish the species of
proteins and sensors to detect abnormal prions in food. Development of these technologies can contribute significantly to the effort to prevent the
spread of BSE and must be considered carefully when evaluating potential regulatory changes to address BSE.
At the time that FDA implemented the feed rule in 1997, the Agency also recognized that evolving, complex scientific and public health issues,
particularly regarding BSE required the Agency to continue to assess and scrutinize the rule to ensure its integrity as a firewall against the potential
for spread of BSE. To further explore ways the animal feed regulation could be improved in November 2002, FDA published an advance notice of
proposed rulemaking (ANPR) soliciting information and views from the affected industries and the public on some potential changes to its current
feed regulation, including ways that the animal feed regulation could be strengthened. Although the risk of exposure to BSE in the U.S. remains
extremely low and the measures in place are working, as a result of the recently discovered infected cow in the state of Washington, the Agency
is evaluating the appropriateness of additional science-based measures to further strengthen our current protections.
Yesterday, Department Secretary Tommy Thompson and FDA Commissioner Mark McClellan announced several additional public health
measures to further strengthen the current robust safeguards that help protect Americans from exposure to the agent that causes BSE and
help prevent the spread of BSE in U.S. cattle. These measures relate to both protections for foods intended for human consumption as well
as additional measures to strengthen FDA’s 1997 final rule regulating animal feed. With respect to human foods, FDA announced that it will
extend to FDA-regulated foods, dietary supplements and cosmetics, restrictions on using specified risk materials that would complement the
recent USDA announcements. Concerning animal feed, the Agency announced a series of measures designed to lower even further the risk
that cattle will be purposefully or inadvertently fed “ruminant” proteins, including, eliminating an exemption in the feed rule that allows mammalian
blood and blood products at slaughter to be fed to ruminants as a protein source; banning the use of “poultry litter” as a feed ingredient for cattle
and other ruminants; prohibiting the use of “plate waste” as a feed ingredient for ruminants, including cattle; and taking steps to further minimize
the possibility of cross-contamination of animal feed via equipment, facilities or production lines.
Finally, FDA is increasing its inspections of feed mills and renderers in 2004. Our 2001 base funding for BSE-related activities was $3.8 million.
We shifted resources internally in 2001 and received a substantial increase from Congress in 2002. Our funded level for 2004 is currently approximately
$21.5 million, almost a five-fold increase over the 2001 base. FDA will itself conduct 2,800 inspections and will make its resources go even further by
working with state agencies to fund 3,100 contract inspections of feed mills and renderers and other firms that handle animal feed and feed ingredients.
Through partnerships with states, FDA will also receive data on 700 additional inspections, for a total of 3,800 state contract and partnership inspections
in 2004. These inspections would include 100 percent of all known renderers and feed mills that process products containing prohibited materials.
The Agency looks forward to continuing to assist Congress as it evaluates the risks associated with BSE, identifies opportunities to promote technologies
that will detect and prevent the spread of BSE, and considers science-based approaches to further strengthen regulatory protections and bolster the
resources available to assist Federal, state, local and private efforts to assure that BSE does not present a threat to human or animal health in the U.S.
Background on Bovine Spongiform Encephalopathy (BSE) .................
snip...
http://www.fda.gov/ola/2004/bse0127.html
For Immediate Release
July 9, 2004
FSIS Press Office
APHIS Press Office
FDA Media Relations
(202) 720-9113
(202) 734-7799
(301) 827-6242
USDA and HHS Strengthen Safeguards Against
Bovine Spongiform Encephalopathy
http://www.fda.gov/bbs/topics/news/2004/NEW01084.html
PLEASE NOTE, WERE STILL WAITING for some of these BSE/TSE safeguards $$$
some of those promises above have still yet to be implemented, AND, the USDA/FDA et al are still feeding cows to cows in 2006 ;
Subject: MAD COW FEED RECALL USA SEPT 6, 2006 1961.72 TONS IN COMMERCE AL,
TN, AND WV
Date: September 6, 2006 at 7:58 am PST
PRODUCT
a) EVSRC Custom dairy feed, Recall # V-130-6;
b) Performance Chick Starter, Recall # V-131-6;
c) Performance Quail Grower, Recall # V-132-6;
d) Performance Pheasant Finisher, Recall # V-133-6.
CODE
None
RECALLING FIRM/MANUFACTURER
Donaldson & Hasenbein/dba J&R Feed Service, Inc., Cullman, AL, by telephone
on June 23, 2006 and by letter dated July 19, 2006. Firm initiated recall is
complete.
REASON
Dairy and poultry feeds were possibly contaminated with ruminant based
protein.
VOLUME OF PRODUCT IN COMMERCE
477.72 tons
DISTRIBUTION
AL
______________________________
PRODUCT
a) Dairy feed, custom, Recall # V-134-6;
b) Custom Dairy Feed with Monensin, Recall # V-135-6.
CODE
None. Bulk product
RECALLING FIRM/MANUFACTURER
Recalling Firm: Burkmann Feed, Greeneville, TN, by Telephone beginning on
June 28, 2006.
Manufacturer: H. J. Baker & Bro., Inc., Albertville, AL. Firm initiated
recall is complete.
REASON
Possible contamination of dairy feeds with ruminant derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
1,484 tons
DISTRIBUTION
TN and WV
http://www.fda.gov/bbs/topics/enforce/2006/ENF00968.html
Subject: MAD COW FEED RECALLS ENFORCEMENT REPORT FOR AUGUST 9, 2006 KY, LA,
MS, AL, GA, AND TN 11,000+ TONS
Date: August 16, 2006 at 9:19 am PST
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II
______________________________
PRODUCT
Bulk custom made dairy feed, Recall # V-115-6
CODE
None
RECALLING FIRM/MANUFACTURER
Hiseville Feed & Seed Co., Hiseville, KY, by telephone and letter on or
about July 14, 2006. FDA initiated recall is ongoing.
REASON
Custom made feeds contain ingredient called Pro-Lak which may contain
ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
Approximately 2,223 tons
DISTRIBUTION
KY
______________________________
PRODUCT
Bulk custom made dairy feed, Recall # V-116-6
CODE
None
RECALLING FIRM/MANUFACTURER
Rips Farm Center, Tollesboro, KY, by telephone and letter on July 14, 2006.
FDA initiated recall is ongoing.
REASON
Custom made feeds contain ingredient called Pro-Lak which may contain
ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
1,220 tons
DISTRIBUTION
KY
______________________________
PRODUCT
Bulk custom made dairy feed, Recall # V-117-6
CODE
None
RECALLING FIRM/MANUFACTURER
Kentwood Co-op, Kentwood, LA, by telephone on June 27, 2006. FDA initiated
recall is completed.
REASON
Possible contamination of animal feed ingredients, including ingredients
that are used in feed for dairy animals, with ruminant derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
40 tons
DISTRIBUTION
LA and MS
______________________________
PRODUCT
Bulk Dairy Feed, Recall V-118-6
CODE
None
RECALLING FIRM/MANUFACTURER
Cal Maine Foods, Inc., Edwards, MS, by telephone on June 26, 2006. FDA
initiated recall is complete.
REASON
Possible contamination of animal feed ingredients, including ingredients
that are used in feed for dairy animals, with ruminant derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
7,150 tons
DISTRIBUTION
MS
______________________________
PRODUCT
Bulk custom dairy pre-mixes, Recall # V-119-6
CODE
None
RECALLING FIRM/MANUFACTURER
Walthall County Co-op, Tylertown, MS, by telephone on June 26, 2006. Firm
initiated recall is complete.
REASON
Possible contamination of dairy animal feeds with ruminant derived meat and
bone meal.
VOLUME OF PRODUCT IN COMMERCE
87 tons
DISTRIBUTION
MS
______________________________
PRODUCT
Bulk custom dairy pre-mixes, Recall # V-120-6
CODE
None
RECALLING FIRM/MANUFACTURER
Ware Milling Inc., Houston, MS, by telephone on June 23, 2006. Firm
initiated recall is complete.
REASON
Possible contamination of dairy animal feeds with ruminant derived meat and
bone meal.
VOLUME OF PRODUCT IN COMMERCE
350 tons
DISTRIBUTION
AL and MS
______________________________
PRODUCT
a) Tucker Milling, LLC Tm 32% Sinking Fish Grower, #2680-Pellet,
50 lb. bags, Recall # V-121-6;
b) Tucker Milling, LLC #31120, Game Bird Breeder Pellet,
50 lb. bags, Recall # V-122-6;
c) Tucker Milling, LLC #31232 Game Bird Grower,
50 lb. bags, Recall # V-123-6;
d) Tucker Milling, LLC 31227-Crumble, Game Bird Starter, BMD
Medicated, 50 lb bags, Recall # V-124-6;
e) Tucker Milling, LLC #31120, Game Bird Breeder, 50 lb bags,
Recall # V-125-6;
f) Tucker Milling, LLC #30230, 30 % Turkey Starter, 50 lb bags,
Recall # V-126-6;
g) Tucker Milling, LLC #30116, TM Broiler Finisher,
50 lb bags, Recall # V-127-6
CODE
All products manufactured from 02/01/2005 until 06/20/2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tucker Milling LLC, Guntersville, AL, by telephone and visit
on June 20, 2006, and by letter on June 23, 2006.
Manufacturer: H. J. Baker and Brothers Inc., Stamford, CT. Firm initiated
recall is ongoing.
REASON
Poultry and fish feeds which were possibly contaminated with ruminant based
protein were not labeled as "Do not feed to ruminants".
VOLUME OF PRODUCT IN COMMERCE
7,541-50 lb bags
DISTRIBUTION
AL, GA, MS, and TN
END OF ENFORCEMENT REPORT FOR AUGUST 9, 2006
###
http://www.fda.gov/bbs/topics/ENFORCE/2006/ENF00964.html
Subject: MAD COW FEED RECALL MI MAMMALIAN PROTEIN VOLUME OF PRODUCT IN
COMMERCE 27,694,240 lbs
Date: August 6, 2006 at 6:14 pm PST
PRODUCT
Bulk custom dairy feds manufactured from concentrates, Recall # V-113-6
CODE
All dairy feeds produced between 2/1/05 and 6/16/06 and containing H. J.
Baker recalled feed products.
RECALLING FIRM/MANUFACTURER
Vita Plus Corp., Gagetown, MI, by visit beginning on June 21, 2006. Firm
initiated recall is complete.
REASON
The feed was manufactured from materials that may have been contaminated
with mammalian protein.
VOLUME OF PRODUCT IN COMMERCE
27,694,240 lbs
DISTRIBUTION
MI
END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006
###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html
Subject: MAD COW FEED RECALL AL AND FL VOLUME OF PRODUCT IN COMMERCE 125
TONS Products manufactured from 02/01/2005 until 06/06/2006
Date: August 6, 2006 at 6:16 pm PST
PRODUCT
a) CO-OP 32% Sinking Catfish, Recall # V-100-6;
b) Performance Sheep Pell W/Decox/A/N, medicated,
net wt. 50 lbs, Recall # V-101-6;
c) Pro 40% Swine Conc Meal -- 50 lb, Recall # V-102-6;
d) CO-OP 32% Sinking Catfish Food Medicated,
Recall # V-103-6;
e) "Big Jim's" BBB Deer Ration, Big Buck Blend,
Recall # V-104-6;
f) CO-OP 40% Hog Supplement Medicated Pelleted,
Tylosin 100 grams/ton, 50 lb. bag, Recall # V-105-6;
g) Pig Starter Pell II, 18% W/MCDX Medicated 282020,
Carbadox -- 0.0055%, Recall # V-106-6;
h) CO-OP STARTER-GROWER CRUMBLES, Complete
Feed for Chickens from Hatch to 20 Weeks, Medicated,
Bacitracin Methylene Disalicylate, 25 and 50 Lbs,
Recall # V-107-6;
i) CO-OP LAYING PELLETS, Complete Feed for Laying
Chickens, Recall # 108-6;
j) CO-OP LAYING CRUMBLES, Recall # V-109-6;
k) CO-OP QUAIL FLIGHT CONDITIONER MEDICATED,
net wt 50 Lbs, Recall # V-110-6;
l) CO-OP QUAIL STARTER MEDICATED, Net Wt. 50 Lbs,
Recall # V-111-6;
m) CO-OP QUAIL GROWER MEDICATED, 50 Lbs,
Recall # V-112-6
CODE
Product manufactured from 02/01/2005 until 06/06/2006
RECALLING FIRM/MANUFACTURER
Alabama Farmers Cooperative, Inc., Decatur, AL, by telephone, fax, email and
visit on June 9, 2006. FDA initiated recall is complete.
REASON
Animal and fish feeds which were possibly contaminated with ruminant based
protein not labeled as "Do not feed to ruminants".
VOLUME OF PRODUCT IN COMMERCE
125 tons
DISTRIBUTION
AL and FL
END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006
###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html
Subject: MAD COW FEED RECALL KY VOLUME OF PRODUCT IN COMMERCE ?????
Date: August 6, 2006 at 6:19 pm PST
PRODUCT
Bulk custom made dairy feed, Recall # V-114-6
CODE
None
RECALLING FIRM/MANUFACTURER
Burkmann Feeds LLC, Glasgow, KY, by letter on July 14, 2006. Firm initiated
recall is ongoing.
REASON
Custom made feeds contain ingredient called Pro-Lak, which may contain
ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
?????
DISTRIBUTION
KY
END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006
###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html
CJD WATCH MESSAGE BOARD
TSS
MAD COW FEED RECALL USA EQUALS 10,878.06 TONS NATIONWIDE
Sun Jul 16, 2006 09:22
71.248.128.67
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
______________________________
PRODUCT
a) PRO-LAK, bulk weight, Protein Concentrate for Lactating Dairy Animals,
Recall # V-079-6;
b) ProAmino II, FOR PREFRESH AND LACTATING COWS, net weight 50lb (22.6 kg),
Recall # V-080-6;
c) PRO-PAK, MARINE & ANIMAL PROTEIN CONCENTRATE FOR USE IN ANIMAL
FEED, Recall # V-081-6;
d) Feather Meal, Recall # V-082-6
CODE
a) Bulk
b) None
c) Bulk
d) Bulk
RECALLING FIRM/MANUFACTURER
H. J. Baker & Bro., Inc., Albertville, AL, by telephone on June 15, 2006 and
by press release on June 16, 2006. Firm initiated recall is ongoing.
REASON
Possible contamination of animal feeds with ruminent derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
10,878.06 tons
DISTRIBUTION
Nationwide
END OF ENFORCEMENT REPORT FOR July 12, 2006
###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00960.html
Subject: MAD COW FEED BAN WARNING LETTER ISSUED MAY 17, 2006
Date: June 27, 2006 at 7:42 am PST
Public Health Service
Food and Drug Administration
New Orleans District
297 Plus Park Blvd.
Nashville, TN 37217
Telephone: 615-781-5380
Fax: 615-781-5391
May 17, 2006
WARNING LETTER NO. 2006-NOL-06
FEDERAL EXPRESS
OVERNIGHT DELIVERY
Mr. William Shirley, Jr., Owner
Louisiana.DBA Riegel By-Products
2621 State Street
Dallas, Texas 75204
Dear Mr. Shirley:
On February 12, 17, 21, and 22, 2006, a U.S. Food & Drug Administration
(FDA) investigator inspected your rendering plant, located at 509 Fortson
Street, Shreveport, Louisiana. The inspection revealed significant
deviations from the requirements set forth in Title 21, Code of Federal
Regulations, Part 589.2000 [21 CFR 589.2000], Animal Proteins Prohibited in
Ruminant Feed. This regulation is intended to prevent the establishment and
amplification of Bovine Spongiform Encephalopathy (BSE). You failed to
follow the requirements of this regulation; products being manufactured and
distributed by your facility are misbranded within the meaning of Section
403(a)(1) [21 USC 343(a)(1)] of the Federal Food, Drug, and Cosmetic Act
(the Act).
Our investigation found you failed to provide measures, including sufficient
written procedures, to prevent commingling or cross-contamination and to
maintain sufficient written procedures [21 CFR 589.2000(e)] because:
You failed to use clean-out procedures or other means adequate to prevent
carryover of protein derived from mammalian tissues into animal protein or
feeds which may be used for ruminants. For example, your facility uses the
same equipment to process mammalian and poultry tissues. However, you use
only hot water to clean the cookers between processing tissues from each
species. You do not clean the auger, hammer mill, grinder, and spouts after
processing mammalian tissues.
You failed to maintain written procedures specifying the clean-out
procedures or other means to prevent carryover of protein derived from
mammalian tissues into feeds which may be used for ruminants.
As a result . the poultry meal you manufacture may contain protein derived
from mammalian tissues prohibited in ruminant feed. Pursuant to 21 CFR
589.2000(e)(1)(i), any products containing or may contain protein derived
from mammalian tissues must be labeled, "Do not feed to cattle or other
ruminants." Since you failed to label a product which may contain protein
derived from mammalian tissues with the required cautionary statement. the
poultry meal is misbranded under Section 403(a)(1) [21 USC 343(a)(1)] of the
Act.
This letter is not intended as an all-inclusive list of violations at your
facility. As a manufacturer of materials intended for animal feed use, you
are responsible for ensuring your overall operation and the products you
manufacture and distribute are in compliance with the law. You should take
prompt action to correct these violations, and you should establish a system
whereby violations do not recur. Failure to promptly correct these
violations may result in regulatory action, such as seizure and/or
injunction, without further notice.
You should notify this office in writing within 15 working days of receiving
this letter, outlining the specific steps you have taken to bring your firm
into compliance with the law. Your response should include an explanation of
each step taken to correct the violations and prevent their recurrence. If
corrective action cannot be completed within 15 working days, state the
reason for the delay and the date by which the corrections will be
completed. Include copies of any available documentation demonstrating
corrections have been made.
Your reply should be directed to Mark W. Rivero, Compliance Officer, U.S.
Food and Drug Administration, 2424 Edenborn Avenue, Suite 410, Metairie,
Louisiana 70001. If you have questions regarding any issue in this letter,
please contact Mr. Rivero at (504) 219-8818, extension 103.
Sincerely,
/S
Carol S. Sanchez
Acting District Director
New Orleans District
http://www.fda.gov/foi/warning_letters/g5883d.htm
look at the table and you'll see that as little as 1 mg (or 0.001 gm) caused
7% (1 of 14) of the cows to come down with BSE;
Risk of oral infection with bovine spongiform encephalopathy agent in
primates
Corinne Ida Lasmézas, Emmanuel Comoy, Stephen Hawkins, Christian Herzog,
Franck Mouthon, Timm Konold, Frédéric Auvré, Evelyne Correia, Nathalie
Lescoutra-Etchegaray, Nicole Salès, Gerald Wells, Paul Brown, Jean-Philippe
Deslys
Summary The uncertain extent of human exposure to bovine spongiform
encephalopathy (BSE)--which can lead to variant Creutzfeldt-Jakob disease
(vCJD)--is compounded by incomplete knowledge about the efficiency of oral
infection and the magnitude of any bovine-to-human biological barrier to
transmission. We therefore investigated oral transmission of BSE to
non-human primates. We gave two macaques a 5 g oral dose of brain homogenate
from a BSE-infected cow. One macaque developed vCJD-like neurological
disease 60 months after exposure, whereas the other remained free of disease
at 76 months. On the basis of these findings and data from other studies, we
made a preliminary estimate of the food exposure risk for man, which
provides additional assurance that existing public health measures can
prevent transmission of BSE to man.
snip...
BSE bovine brain inoculum
100 g 10 g 5 g 1 g 100 mg 10 mg 1 mg 0·1 mg 0·01 mg
Primate (oral route)* 1/2 (50%)
Cattle (oral route)* 10/10 (100%) 7/9 (78%) 7/10 (70%) 3/15 (20%) 1/15 (7%)
1/15 (7%)
RIII mice (ic ip route)* 17/18 (94%) 15/17 (88%) 1/14 (7%)
PrPres biochemical detection
The comparison is made on the basis of calibration of the bovine inoculum
used in our study with primates against a bovine brain inoculum with a
similar PrPres concentration that was
inoculated into mice and cattle.8 *Data are number of animals
positive/number of animals surviving at the time of clinical onset of
disease in the first positive animal (%). The accuracy of
bioassays is generally judged to be about plus or minus 1 log. ic
ip=intracerebral and intraperitoneal.
Table 1: Comparison of transmission rates in primates and cattle infected
orally with similar BSE brain inocula
Published online January 27, 2005
http://www.thelancet.com/journal/journal.isa
[Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine
Spongiform Encephalopathy (BSE)
http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf
[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
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf
THE SEVEN SCIENTIST REPORT ***
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-EC244-Attach-1.pdf
PAUL BROWN M.D.
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000490-vol40.pdf
9 December 2005
Division of Dockets Management (RFA-305)
SEROLOGICALS CORPORATION
James J. Kramer, Ph.D.
Vice President, Corporate Operations
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000383-01-vol35.pdf
Embassy of Japan
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02N-0273-EC240.htm
END
still sadly disgusted,
Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518
BY
LESTER M. CRAWFORD, D.V.M., PH.D.
DEPUTY COMMISSIONER OF FOOD AND DRUGS
DEPARTMENT OF HEALTH AND HUMAN SERVICES
BEFORE
THE COMMITTEE ON AGRICULTURE, NUTRITION, AND FORESTRY
UNITED STATES SENATE
JANUARY 27, 2004
Introduction
Mr. Chairman, Members of the Committee, thank you for the opportunity to participate in today’s hearing on measures taken by the Federal government to
safeguard human and animal health in the United States from Bovine Spongiform Encephalopathy (BSE) and the response to the finding of a BSE-positive
cow in the State of Washington. I am Dr. Lester M. Crawford, Deputy Commissioner, Food and Drug Administration (FDA or the Agency).
The mission of FDA is to protect the public health by assuring the safety and efficacy of our nation’s human and veterinary drugs, human biological products,
medical devices, human and animal food supply, cosmetics, and radiation emitting products. In fulfilling this mission, FDA is the Agency responsible for
assuring that all FDA-regulated products remain safe and uncompromised from BSE and related diseases. Many FDA-regulated products contain bovine
ingredients, for example, heart valves, ophthalmic devices, dental products, wound dressings, injectable drugs, vaccines, soups, gravies, sausage casings,
and animal feeds.
FDA has long been actively involved nationally and internationally in efforts to understand and prevent the spread of BSE. FDA collaborates extensively with
the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the Animal and Plant Health Inspection Service (APHIS) and
the Food Safety and Inspection Service (FSIS) within the U.S. Department of Agriculture (USDA), Customs and Border Protection (CBP), the Environmental
Protection Agency (EPA), other Federal agencies, state and local jurisdictions, and with affected industries and consumer groups. Many of these activities
fit within the framework of the Department of Health and Human Service’s (HHS or the Department) Bovine Spongiform Encephalopathy/Transmissible
Spongiform Encephalopathy (BSE/TSE) Action Plan, which was released in August 2001. This collaboration over many years has enabled FDA to strengthen
safeguards for FDA-regulated products and to respond quickly and effectively to the first case of BSE within the U.S.
Executive Summary
The mission of the Agency is to protect the public health by assuring the safety and efficacy of our nation’s human and veterinary drugs, human biological
products, medical devices, human and animal food supply, cosmetics, and radiation emitting products. In fulfilling this mission, FDA is the Agency
responsible for assuring that all FDA-regulated products remain safe and uncompromised from BSE and related diseases.
BSE is a progressive neurological disorder of cattle that results from infection by an unconventional transmissible agent, and was first diagnosed in the
United Kingdom (U.K.) in 1986. Many FDA-regulated products contain bovine ingredients, for example, heart valves, ophthalmic devices, dental products,
wound dressings, injectable drugs, vaccines, soups, gravies, sausage casings, and animal feeds and thus must be taken into consideration as part the
effort to prevent infectivity by BSE.
FDA has a longstanding commitment to protecting consumers from BSE by following multiple measures designed to safeguard FDA-regulated products
from possible contamination by the BSE agent. Under the Federal Food, Drug, and Cosmetic (FD&C) Act, FDA has the authority to prevent the adulteration
and misbranding of FDA-regulated products. Further, for medical products that require pre-market approval (e.g., drugs under Section 505 and medical
devices under Section 513 of the FD&C Act), FDA has addressed safety concerns related to BSE through requirements of the application and approval
process.
The U.S. employs a robust multi-layered approach to preventing the introduction and amplification of BSE. While the goal of this approach is to achieve
an extremely high level of compliance with each preventative measure, this multi-layered approach is designed to protect the U.S. consumer from exposure
to the BSE infective material, and to date this approach has been working. Since 1989, USDA has prohibited the importation of live animals and animal
products from BSE-positive countries. Since 1997, FDA has prohibited the use of certain mammalian proteins in the manufacture of ruminant feed. FDA
continues to implement policies to keep safe all FDA-regulated products, including food, food ingredients, dietary supplements, drugs, vaccines, and
cosmetics from risk of any BSE-contaminated bovine material. As a result of these multiple regulatory safeguards, the risk of exposure to BSE through
products, FDA regulates remains extremely low in the U.S.
FDA’s 1997 animal feed regulation forms the basis of the Agency’s efforts to prevent the spread of BSE through animal feed. This rule prohibits the use
of most mammalian protein in the manufacture of animal feeds for ruminants. FDA implemented this rule to establish in our country feeding practices
consistent with the best science and epidemiological knowledge known at the time to prevent the spread of BSE throughout herds of U.S. cattle. A risk
assessment sponsored by USDA and conducted by the Harvard Center for Risk Analysis, released in November 2001, identified FDA’s feed ban as one
of the primary safeguards against the spread of BSE in U.S. cattle.
To maximize protection afforded by the feed regulation, FDA has developed and implemented a BSE/Ruminant Feed Ban Inspection compliance program
and established the goal of 100 percent compliance. FDA’s strategy for achieving uniform compliance with the feed rule focuses on three areas: education,
inspection, and enforcement. FDA and its state counterparts conduct, at least annually, targeted BSE inspections of 100 percent of known renderers,
protein blenders, and feed mills processing products containing material prohibited from use in ruminant feed. Compliance by these establishments
with FDA’s feed rule is estimated to be at better than 99 percent. As of December 20, 2003, FDA had received over 26,000 inspection reports
(6,404 for Fiscal Year 2003). The majority of these inspections (around 70 percent) were conducted by state officials for FDA, with the remainder conducted
by FDA officials. The total number of inspection reports represents 13,672 firms, 1,949 of which are active and handle materials prohibited from use in
ruminant feed. The 1,949 active firms that handle prohibited material have been inspected by FDA and, as of December 31, 2003, only five were found to
have significant violations, resulting in official action indicated (OAI). FDA is working with these firms to bring them into compliance.
On December 23, 2003, FDA was notified by USDA of a presumptive-positive finding of BSE in a cow in Washington State. FDA immediately initiated its BSE
Emergency Response Plan. As part of the plan, FDA has been coordinately closely with USDA so that we can effectively investigate this BSE case, trace the
various products involved, and take the appropriate steps to protect the public. FDA investigators and inspectors located the high risk material rendered
from the infected cow, and the rendering plants placed a hold on the rendered material, which is being disposed of appropriately. I am happy to report that
all of the establishments inspected by FDA during the course of the investigation were in compliance with the feed ban. In addition, to help address the
concerns of foreign governments and restore confidence in American products, FDA has participated, along with USDA, in numerous meetings and
consultations with foreign governments since USDA surveillance found the BSE-positive cow.
In addition to new policies and regulations, new knowledge and tools gained through applied research can greatly help us to be more effective in our
regulatory mission, such as protecting the country from BSE. Several of FDA’s Centers, as well as many private laboratories, academic institutions, and
other Federal agencies (most notably NIH) are also involved in significant research activities relating to TSEs. Basic areas requiring research include:
increasing our understanding of prions, learning how prions are transmitted within a species and potentially between species, developing diagnostic
tests for humans and animals, developing detection methods for use on regulated products, developing methods to increase or eliminate infectivity,
and designing new treatments. We are optimistic about the promise of new technologies, such as better methods to quickly distinguish the species of
proteins and sensors to detect abnormal prions in food. Development of these technologies can contribute significantly to the effort to prevent the
spread of BSE and must be considered carefully when evaluating potential regulatory changes to address BSE.
At the time that FDA implemented the feed rule in 1997, the Agency also recognized that evolving, complex scientific and public health issues,
particularly regarding BSE required the Agency to continue to assess and scrutinize the rule to ensure its integrity as a firewall against the potential
for spread of BSE. To further explore ways the animal feed regulation could be improved in November 2002, FDA published an advance notice of
proposed rulemaking (ANPR) soliciting information and views from the affected industries and the public on some potential changes to its current
feed regulation, including ways that the animal feed regulation could be strengthened. Although the risk of exposure to BSE in the U.S. remains
extremely low and the measures in place are working, as a result of the recently discovered infected cow in the state of Washington, the Agency
is evaluating the appropriateness of additional science-based measures to further strengthen our current protections.
Yesterday, Department Secretary Tommy Thompson and FDA Commissioner Mark McClellan announced several additional public health
measures to further strengthen the current robust safeguards that help protect Americans from exposure to the agent that causes BSE and
help prevent the spread of BSE in U.S. cattle. These measures relate to both protections for foods intended for human consumption as well
as additional measures to strengthen FDA’s 1997 final rule regulating animal feed. With respect to human foods, FDA announced that it will
extend to FDA-regulated foods, dietary supplements and cosmetics, restrictions on using specified risk materials that would complement the
recent USDA announcements. Concerning animal feed, the Agency announced a series of measures designed to lower even further the risk
that cattle will be purposefully or inadvertently fed “ruminant” proteins, including, eliminating an exemption in the feed rule that allows mammalian
blood and blood products at slaughter to be fed to ruminants as a protein source; banning the use of “poultry litter” as a feed ingredient for cattle
and other ruminants; prohibiting the use of “plate waste” as a feed ingredient for ruminants, including cattle; and taking steps to further minimize
the possibility of cross-contamination of animal feed via equipment, facilities or production lines.
Finally, FDA is increasing its inspections of feed mills and renderers in 2004. Our 2001 base funding for BSE-related activities was $3.8 million.
We shifted resources internally in 2001 and received a substantial increase from Congress in 2002. Our funded level for 2004 is currently approximately
$21.5 million, almost a five-fold increase over the 2001 base. FDA will itself conduct 2,800 inspections and will make its resources go even further by
working with state agencies to fund 3,100 contract inspections of feed mills and renderers and other firms that handle animal feed and feed ingredients.
Through partnerships with states, FDA will also receive data on 700 additional inspections, for a total of 3,800 state contract and partnership inspections
in 2004. These inspections would include 100 percent of all known renderers and feed mills that process products containing prohibited materials.
The Agency looks forward to continuing to assist Congress as it evaluates the risks associated with BSE, identifies opportunities to promote technologies
that will detect and prevent the spread of BSE, and considers science-based approaches to further strengthen regulatory protections and bolster the
resources available to assist Federal, state, local and private efforts to assure that BSE does not present a threat to human or animal health in the U.S.
Background on Bovine Spongiform Encephalopathy (BSE) .................
snip...
http://www.fda.gov/ola/2004/bse0127.html
For Immediate Release
July 9, 2004
FSIS Press Office
APHIS Press Office
FDA Media Relations
(202) 720-9113
(202) 734-7799
(301) 827-6242
USDA and HHS Strengthen Safeguards Against
Bovine Spongiform Encephalopathy
http://www.fda.gov/bbs/topics/news/2004/NEW01084.html
PLEASE NOTE, WERE STILL WAITING for some of these BSE/TSE safeguards $$$
some of those promises above have still yet to be implemented, AND, the USDA/FDA et al are still feeding cows to cows in 2006 ;
Subject: MAD COW FEED RECALL USA SEPT 6, 2006 1961.72 TONS IN COMMERCE AL,
TN, AND WV
Date: September 6, 2006 at 7:58 am PST
PRODUCT
a) EVSRC Custom dairy feed, Recall # V-130-6;
b) Performance Chick Starter, Recall # V-131-6;
c) Performance Quail Grower, Recall # V-132-6;
d) Performance Pheasant Finisher, Recall # V-133-6.
CODE
None
RECALLING FIRM/MANUFACTURER
Donaldson & Hasenbein/dba J&R Feed Service, Inc., Cullman, AL, by telephone
on June 23, 2006 and by letter dated July 19, 2006. Firm initiated recall is
complete.
REASON
Dairy and poultry feeds were possibly contaminated with ruminant based
protein.
VOLUME OF PRODUCT IN COMMERCE
477.72 tons
DISTRIBUTION
AL
______________________________
PRODUCT
a) Dairy feed, custom, Recall # V-134-6;
b) Custom Dairy Feed with Monensin, Recall # V-135-6.
CODE
None. Bulk product
RECALLING FIRM/MANUFACTURER
Recalling Firm: Burkmann Feed, Greeneville, TN, by Telephone beginning on
June 28, 2006.
Manufacturer: H. J. Baker & Bro., Inc., Albertville, AL. Firm initiated
recall is complete.
REASON
Possible contamination of dairy feeds with ruminant derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
1,484 tons
DISTRIBUTION
TN and WV
http://www.fda.gov/bbs/topics/enforce/2006/ENF00968.html
Subject: MAD COW FEED RECALLS ENFORCEMENT REPORT FOR AUGUST 9, 2006 KY, LA,
MS, AL, GA, AND TN 11,000+ TONS
Date: August 16, 2006 at 9:19 am PST
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II
______________________________
PRODUCT
Bulk custom made dairy feed, Recall # V-115-6
CODE
None
RECALLING FIRM/MANUFACTURER
Hiseville Feed & Seed Co., Hiseville, KY, by telephone and letter on or
about July 14, 2006. FDA initiated recall is ongoing.
REASON
Custom made feeds contain ingredient called Pro-Lak which may contain
ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
Approximately 2,223 tons
DISTRIBUTION
KY
______________________________
PRODUCT
Bulk custom made dairy feed, Recall # V-116-6
CODE
None
RECALLING FIRM/MANUFACTURER
Rips Farm Center, Tollesboro, KY, by telephone and letter on July 14, 2006.
FDA initiated recall is ongoing.
REASON
Custom made feeds contain ingredient called Pro-Lak which may contain
ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
1,220 tons
DISTRIBUTION
KY
______________________________
PRODUCT
Bulk custom made dairy feed, Recall # V-117-6
CODE
None
RECALLING FIRM/MANUFACTURER
Kentwood Co-op, Kentwood, LA, by telephone on June 27, 2006. FDA initiated
recall is completed.
REASON
Possible contamination of animal feed ingredients, including ingredients
that are used in feed for dairy animals, with ruminant derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
40 tons
DISTRIBUTION
LA and MS
______________________________
PRODUCT
Bulk Dairy Feed, Recall V-118-6
CODE
None
RECALLING FIRM/MANUFACTURER
Cal Maine Foods, Inc., Edwards, MS, by telephone on June 26, 2006. FDA
initiated recall is complete.
REASON
Possible contamination of animal feed ingredients, including ingredients
that are used in feed for dairy animals, with ruminant derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
7,150 tons
DISTRIBUTION
MS
______________________________
PRODUCT
Bulk custom dairy pre-mixes, Recall # V-119-6
CODE
None
RECALLING FIRM/MANUFACTURER
Walthall County Co-op, Tylertown, MS, by telephone on June 26, 2006. Firm
initiated recall is complete.
REASON
Possible contamination of dairy animal feeds with ruminant derived meat and
bone meal.
VOLUME OF PRODUCT IN COMMERCE
87 tons
DISTRIBUTION
MS
______________________________
PRODUCT
Bulk custom dairy pre-mixes, Recall # V-120-6
CODE
None
RECALLING FIRM/MANUFACTURER
Ware Milling Inc., Houston, MS, by telephone on June 23, 2006. Firm
initiated recall is complete.
REASON
Possible contamination of dairy animal feeds with ruminant derived meat and
bone meal.
VOLUME OF PRODUCT IN COMMERCE
350 tons
DISTRIBUTION
AL and MS
______________________________
PRODUCT
a) Tucker Milling, LLC Tm 32% Sinking Fish Grower, #2680-Pellet,
50 lb. bags, Recall # V-121-6;
b) Tucker Milling, LLC #31120, Game Bird Breeder Pellet,
50 lb. bags, Recall # V-122-6;
c) Tucker Milling, LLC #31232 Game Bird Grower,
50 lb. bags, Recall # V-123-6;
d) Tucker Milling, LLC 31227-Crumble, Game Bird Starter, BMD
Medicated, 50 lb bags, Recall # V-124-6;
e) Tucker Milling, LLC #31120, Game Bird Breeder, 50 lb bags,
Recall # V-125-6;
f) Tucker Milling, LLC #30230, 30 % Turkey Starter, 50 lb bags,
Recall # V-126-6;
g) Tucker Milling, LLC #30116, TM Broiler Finisher,
50 lb bags, Recall # V-127-6
CODE
All products manufactured from 02/01/2005 until 06/20/2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tucker Milling LLC, Guntersville, AL, by telephone and visit
on June 20, 2006, and by letter on June 23, 2006.
Manufacturer: H. J. Baker and Brothers Inc., Stamford, CT. Firm initiated
recall is ongoing.
REASON
Poultry and fish feeds which were possibly contaminated with ruminant based
protein were not labeled as "Do not feed to ruminants".
VOLUME OF PRODUCT IN COMMERCE
7,541-50 lb bags
DISTRIBUTION
AL, GA, MS, and TN
END OF ENFORCEMENT REPORT FOR AUGUST 9, 2006
###
http://www.fda.gov/bbs/topics/ENFORCE/2006/ENF00964.html
Subject: MAD COW FEED RECALL MI MAMMALIAN PROTEIN VOLUME OF PRODUCT IN
COMMERCE 27,694,240 lbs
Date: August 6, 2006 at 6:14 pm PST
PRODUCT
Bulk custom dairy feds manufactured from concentrates, Recall # V-113-6
CODE
All dairy feeds produced between 2/1/05 and 6/16/06 and containing H. J.
Baker recalled feed products.
RECALLING FIRM/MANUFACTURER
Vita Plus Corp., Gagetown, MI, by visit beginning on June 21, 2006. Firm
initiated recall is complete.
REASON
The feed was manufactured from materials that may have been contaminated
with mammalian protein.
VOLUME OF PRODUCT IN COMMERCE
27,694,240 lbs
DISTRIBUTION
MI
END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006
###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html
Subject: MAD COW FEED RECALL AL AND FL VOLUME OF PRODUCT IN COMMERCE 125
TONS Products manufactured from 02/01/2005 until 06/06/2006
Date: August 6, 2006 at 6:16 pm PST
PRODUCT
a) CO-OP 32% Sinking Catfish, Recall # V-100-6;
b) Performance Sheep Pell W/Decox/A/N, medicated,
net wt. 50 lbs, Recall # V-101-6;
c) Pro 40% Swine Conc Meal -- 50 lb, Recall # V-102-6;
d) CO-OP 32% Sinking Catfish Food Medicated,
Recall # V-103-6;
e) "Big Jim's" BBB Deer Ration, Big Buck Blend,
Recall # V-104-6;
f) CO-OP 40% Hog Supplement Medicated Pelleted,
Tylosin 100 grams/ton, 50 lb. bag, Recall # V-105-6;
g) Pig Starter Pell II, 18% W/MCDX Medicated 282020,
Carbadox -- 0.0055%, Recall # V-106-6;
h) CO-OP STARTER-GROWER CRUMBLES, Complete
Feed for Chickens from Hatch to 20 Weeks, Medicated,
Bacitracin Methylene Disalicylate, 25 and 50 Lbs,
Recall # V-107-6;
i) CO-OP LAYING PELLETS, Complete Feed for Laying
Chickens, Recall # 108-6;
j) CO-OP LAYING CRUMBLES, Recall # V-109-6;
k) CO-OP QUAIL FLIGHT CONDITIONER MEDICATED,
net wt 50 Lbs, Recall # V-110-6;
l) CO-OP QUAIL STARTER MEDICATED, Net Wt. 50 Lbs,
Recall # V-111-6;
m) CO-OP QUAIL GROWER MEDICATED, 50 Lbs,
Recall # V-112-6
CODE
Product manufactured from 02/01/2005 until 06/06/2006
RECALLING FIRM/MANUFACTURER
Alabama Farmers Cooperative, Inc., Decatur, AL, by telephone, fax, email and
visit on June 9, 2006. FDA initiated recall is complete.
REASON
Animal and fish feeds which were possibly contaminated with ruminant based
protein not labeled as "Do not feed to ruminants".
VOLUME OF PRODUCT IN COMMERCE
125 tons
DISTRIBUTION
AL and FL
END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006
###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html
Subject: MAD COW FEED RECALL KY VOLUME OF PRODUCT IN COMMERCE ?????
Date: August 6, 2006 at 6:19 pm PST
PRODUCT
Bulk custom made dairy feed, Recall # V-114-6
CODE
None
RECALLING FIRM/MANUFACTURER
Burkmann Feeds LLC, Glasgow, KY, by letter on July 14, 2006. Firm initiated
recall is ongoing.
REASON
Custom made feeds contain ingredient called Pro-Lak, which may contain
ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
?????
DISTRIBUTION
KY
END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006
###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html
CJD WATCH MESSAGE BOARD
TSS
MAD COW FEED RECALL USA EQUALS 10,878.06 TONS NATIONWIDE
Sun Jul 16, 2006 09:22
71.248.128.67
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
______________________________
PRODUCT
a) PRO-LAK, bulk weight, Protein Concentrate for Lactating Dairy Animals,
Recall # V-079-6;
b) ProAmino II, FOR PREFRESH AND LACTATING COWS, net weight 50lb (22.6 kg),
Recall # V-080-6;
c) PRO-PAK, MARINE & ANIMAL PROTEIN CONCENTRATE FOR USE IN ANIMAL
FEED, Recall # V-081-6;
d) Feather Meal, Recall # V-082-6
CODE
a) Bulk
b) None
c) Bulk
d) Bulk
RECALLING FIRM/MANUFACTURER
H. J. Baker & Bro., Inc., Albertville, AL, by telephone on June 15, 2006 and
by press release on June 16, 2006. Firm initiated recall is ongoing.
REASON
Possible contamination of animal feeds with ruminent derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
10,878.06 tons
DISTRIBUTION
Nationwide
END OF ENFORCEMENT REPORT FOR July 12, 2006
###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00960.html
Subject: MAD COW FEED BAN WARNING LETTER ISSUED MAY 17, 2006
Date: June 27, 2006 at 7:42 am PST
Public Health Service
Food and Drug Administration
New Orleans District
297 Plus Park Blvd.
Nashville, TN 37217
Telephone: 615-781-5380
Fax: 615-781-5391
May 17, 2006
WARNING LETTER NO. 2006-NOL-06
FEDERAL EXPRESS
OVERNIGHT DELIVERY
Mr. William Shirley, Jr., Owner
Louisiana.DBA Riegel By-Products
2621 State Street
Dallas, Texas 75204
Dear Mr. Shirley:
On February 12, 17, 21, and 22, 2006, a U.S. Food & Drug Administration
(FDA) investigator inspected your rendering plant, located at 509 Fortson
Street, Shreveport, Louisiana. The inspection revealed significant
deviations from the requirements set forth in Title 21, Code of Federal
Regulations, Part 589.2000 [21 CFR 589.2000], Animal Proteins Prohibited in
Ruminant Feed. This regulation is intended to prevent the establishment and
amplification of Bovine Spongiform Encephalopathy (BSE). You failed to
follow the requirements of this regulation; products being manufactured and
distributed by your facility are misbranded within the meaning of Section
403(a)(1) [21 USC 343(a)(1)] of the Federal Food, Drug, and Cosmetic Act
(the Act).
Our investigation found you failed to provide measures, including sufficient
written procedures, to prevent commingling or cross-contamination and to
maintain sufficient written procedures [21 CFR 589.2000(e)] because:
You failed to use clean-out procedures or other means adequate to prevent
carryover of protein derived from mammalian tissues into animal protein or
feeds which may be used for ruminants. For example, your facility uses the
same equipment to process mammalian and poultry tissues. However, you use
only hot water to clean the cookers between processing tissues from each
species. You do not clean the auger, hammer mill, grinder, and spouts after
processing mammalian tissues.
You failed to maintain written procedures specifying the clean-out
procedures or other means to prevent carryover of protein derived from
mammalian tissues into feeds which may be used for ruminants.
As a result . the poultry meal you manufacture may contain protein derived
from mammalian tissues prohibited in ruminant feed. Pursuant to 21 CFR
589.2000(e)(1)(i), any products containing or may contain protein derived
from mammalian tissues must be labeled, "Do not feed to cattle or other
ruminants." Since you failed to label a product which may contain protein
derived from mammalian tissues with the required cautionary statement. the
poultry meal is misbranded under Section 403(a)(1) [21 USC 343(a)(1)] of the
Act.
This letter is not intended as an all-inclusive list of violations at your
facility. As a manufacturer of materials intended for animal feed use, you
are responsible for ensuring your overall operation and the products you
manufacture and distribute are in compliance with the law. You should take
prompt action to correct these violations, and you should establish a system
whereby violations do not recur. Failure to promptly correct these
violations may result in regulatory action, such as seizure and/or
injunction, without further notice.
You should notify this office in writing within 15 working days of receiving
this letter, outlining the specific steps you have taken to bring your firm
into compliance with the law. Your response should include an explanation of
each step taken to correct the violations and prevent their recurrence. If
corrective action cannot be completed within 15 working days, state the
reason for the delay and the date by which the corrections will be
completed. Include copies of any available documentation demonstrating
corrections have been made.
Your reply should be directed to Mark W. Rivero, Compliance Officer, U.S.
Food and Drug Administration, 2424 Edenborn Avenue, Suite 410, Metairie,
Louisiana 70001. If you have questions regarding any issue in this letter,
please contact Mr. Rivero at (504) 219-8818, extension 103.
Sincerely,
/S
Carol S. Sanchez
Acting District Director
New Orleans District
http://www.fda.gov/foi/warning_letters/g5883d.htm
look at the table and you'll see that as little as 1 mg (or 0.001 gm) caused
7% (1 of 14) of the cows to come down with BSE;
Risk of oral infection with bovine spongiform encephalopathy agent in
primates
Corinne Ida Lasmézas, Emmanuel Comoy, Stephen Hawkins, Christian Herzog,
Franck Mouthon, Timm Konold, Frédéric Auvré, Evelyne Correia, Nathalie
Lescoutra-Etchegaray, Nicole Salès, Gerald Wells, Paul Brown, Jean-Philippe
Deslys
Summary The uncertain extent of human exposure to bovine spongiform
encephalopathy (BSE)--which can lead to variant Creutzfeldt-Jakob disease
(vCJD)--is compounded by incomplete knowledge about the efficiency of oral
infection and the magnitude of any bovine-to-human biological barrier to
transmission. We therefore investigated oral transmission of BSE to
non-human primates. We gave two macaques a 5 g oral dose of brain homogenate
from a BSE-infected cow. One macaque developed vCJD-like neurological
disease 60 months after exposure, whereas the other remained free of disease
at 76 months. On the basis of these findings and data from other studies, we
made a preliminary estimate of the food exposure risk for man, which
provides additional assurance that existing public health measures can
prevent transmission of BSE to man.
snip...
BSE bovine brain inoculum
100 g 10 g 5 g 1 g 100 mg 10 mg 1 mg 0·1 mg 0·01 mg
Primate (oral route)* 1/2 (50%)
Cattle (oral route)* 10/10 (100%) 7/9 (78%) 7/10 (70%) 3/15 (20%) 1/15 (7%)
1/15 (7%)
RIII mice (ic ip route)* 17/18 (94%) 15/17 (88%) 1/14 (7%)
PrPres biochemical detection
The comparison is made on the basis of calibration of the bovine inoculum
used in our study with primates against a bovine brain inoculum with a
similar PrPres concentration that was
inoculated into mice and cattle.8 *Data are number of animals
positive/number of animals surviving at the time of clinical onset of
disease in the first positive animal (%). The accuracy of
bioassays is generally judged to be about plus or minus 1 log. ic
ip=intracerebral and intraperitoneal.
Table 1: Comparison of transmission rates in primates and cattle infected
orally with similar BSE brain inocula
Published online January 27, 2005
http://www.thelancet.com/journal/journal.isa
[Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine
Spongiform Encephalopathy (BSE)
http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf
[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
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf
THE SEVEN SCIENTIST REPORT ***
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-EC244-Attach-1.pdf
PAUL BROWN M.D.
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000490-vol40.pdf
9 December 2005
Division of Dockets Management (RFA-305)
SEROLOGICALS CORPORATION
James J. Kramer, Ph.D.
Vice President, Corporate Operations
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000383-01-vol35.pdf
Embassy of Japan
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02N-0273-EC240.htm
END
still sadly disgusted,
Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518
For more information:
http://disc.server.com/Indices/236650.html
Ghandi once said that the greatness of a nation could be measured by the way it treats its animals. USA is large, but not "great" if the laws protect those who mistreat, abuse, kill and torture animals for profits and anyone speaking out is labeled a "terrorist"! Anyone with compassion for the discarded creatures of the human race is therefore a terrorist? Pity for our world and this so-called Christian nation.
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