CANADA FAR EXCEEDS USA FDA ON MAD COW FEED CONTROLS

[flounder]

CANADA STRENGTHENS FEED CONTROLS

OTTAWA, June 26, 2006 (15:00 EST) - The Canadian Food Inspection Agency
is banning cattle tissues capable of transmitting bovine spongiform
encephalopathy (BSE) from all animal feeds, pet foods and fertilizers.
The enhancement will significantly accelerate Canada's progress toward
eradicating the disease from the national cattle herd by preventing more
than 99% of any potential BSE infectivity from entering the Canadian
feed system.

The banned tissues, which are collectively known as specified risk
material (SRM), have been shown in infected cattle to contain
concentrated levels of the BSE agent. Canada has already applied
identical protection to the human food system, where SRM are removed
from all cattle slaughtered for human consumption. This measure is
internationally recognized as the most effective way to protect the
safety of food from BSE.

"This ban tightens already strong, internationally recognized feed
controls and shortens the path we must follow to move beyond BSE," said
the Honourable Chuck Strahl, Minister of Agriculture and Agri-Food and
Minister for the Canadian Wheat Board. "Preventing all these materials
from entering the animal feed chain minimizes risks and demonstrates the
commitment of Canada's new government to take necessary, science-based
actions to address BSE."

Ongoing surveillance testing continues to indicate that the level of BSE
in Canada is very low. This is attributable to Canada's current feed
ban, which has prohibited the use of SRM in feed for cattle and other
ruminant animals since 1997. Extending SRM controls to all animal feeds
addresses potential contamination that could occur during feed
production, transportation, storage and use. Removing SRM from pet food
and fertilizers is intended to mitigate the risk associated with the
potential exposure of cattle and other susceptible animals to BSE
through the misuse of these products.

The new outcome-based regulations enter into force on July 12, 2007,
with additional time provided for small establishments to achieve full
compliance. In the meantime, an awareness campaign will be undertaken to
ensure that all regulated parties are fully aware of their
responsibilities and have adjusted their practices and procedures as
required. Special emphasis will be placed on working closely and in full
cooperation with small abattoirs to help them transition to the new
requirements and facilitate their long-term viability. The Government
has set aside $80 million to work with the provinces to assist
industry's implementation of the new feed controls.

Enhanced feed controls complete the Government's response to the
detection of BSE, consistent with the recommendations of the
international team of experts that reviewed Canada's situation. As a
priority, Canada first focused on human health protection, which was
achieved through the removal of SRM from the food system. Attention then
turned to animal health measures through intensified surveillance
testing for BSE and increased animal tracing capabilities.

SRM are defined as the skull, brain, trigeminal ganglia (nerves attached
to the brain), eyes, tonsils, spinal cord and dorsal root ganglia
(nerves attached to the spinal cord) of cattle aged 30 months or older
and the distal ileum (portion of the small intestine) of cattle of all
ages.

For more information:
Fact Sheet: Canada's Enhanced Feed Ban

http://www.inspection.gc.ca/english/ani ... rene.shtml




USA FDA

FLIP ;


C. Animal Feed Restrictions

Specified Risk Materials (SRMs)
In the ``Feed Restrictions'' section of the report, the IRT
recommended: ``All SRM should be excluded from all animal feed,
including pet food.'' [p. 5] FDA has prohibited the use of most
mammalian proteins in ruminant feed since 1997. The IRT report stated
that, ``Considering the BSE situation in North America, the [IRT]
believes the partial (ruminant to ruminant) feed ban that is currently
in place is insufficient to prevent exposure of cattle to the BSE
agent.'' [p. 5] The IRT further stated that, ``While science would
support the feed bans limited to the prohibition of ruminant derived
[meat and bone meal] MBM in ruminant feed, practical difficulties of
enforcement demand more pragmatic and effective solutions.'' [p. 6]
Specifically, the IRT cited epidemiological evidence in the United
Kingdom that highlight the dangers of cattle infection through the
consumption of feed that had been contaminated accidentally when
manufactured in premises that legitimately used mammalian meat and bone
meal in feed for pigs and poultry. [p. 5] In addition, the IRT report
cited an ongoing attack rate study at the Veterinary Laboratories
Agency in the United Kingdom that demonstrates

[[Page 42297]]

transmission of BSE with 10 mg of infectious brain tissue. [p. 5]
Although not yet published, more recent results from this study have
demonstrated transmission with a lower dose of infectious brain tissue.
These levels are significantly lower than the 1 gram infectious dose
that had been demonstrated in the same study at the time the 1997 BSE
feed rule was issued. Further, the Harvard-Tuskegee Study showed that
removing SRMs from all animal feed reduces by 88 percent the potential
exposure of cattle to the BSE agent when 10 BSE infected cattle are
introduced into the United States. Accordingly, FDA has tentatively
concluded that it should propose removing SRMs from all animal feed to
adequately control the risks associated with cross contamination
throughout feed manufacture and distribution and with intentional or
unintentional misfeeding on the farm. FDA is currently working on a
proposal to accomplish this goal.


http://www.fda.gov/OHRMS/DOCKETS/98fr/04-15882.htm



http://www.fda.gov/OHRMS/DOCKETS/98fr/05-20196.htm


III. Significance of Guidance

This level 1 guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The guidance represents
the agency's current thinking about the manufacture and labeling of raw
meat foods for companion and captive noncompanion carnivores and
omnivores. It does not create or confer any rights for or on any person
and will not operate to bind FDA or the public. An alternative approach
may be used if such approach satisfies the requirements of the
applicable statutes and regulations.


http://www.fda.gov/OHRMS/DOCKETS/98fr/04-11366.htm


FLOP ;


Currently in the U.S. , animal products that are prohibited from cattle feed
are _acceptable_ for use in pet food. Such products include meat and bone
meal, for example. However, FDA believes that the safeguards it has put into
place (i.e. ruminant feed rule) to prevent BSE in the U.S. have also
protected cats. To date, no case of FSE has been found in the U.S. FDA
continues to review these safeguards to be sure they are adequate,
especially in light of the BSE case found in Washington State in December,
2003. ...



http://www.fda.gov/cvm/petfoods.htm



BSE, BOVINE - USA: FEED RECALL
*******************************
A ProMED-mail post
<http://www.promedmail.org>
ProMED-mail is a program of the
International Society for Infectious Diseases
<http://www.isid.org>

Date: 21 Jun 2006
From: Terry Singeltary <[email protected]>
Source: Chron.com, 20 Jun 2006 [edited]
<http://www.chron.com/disp/story.mpl/ap/fn/3987413.html>


Mad Cow Feed Recall, USA, Albertville, AL, 16 Jun 2006; Feed Recalled
Over Mad Cow Violation
-----------------------------------------------
Livestock feed ingredients shipped to 9 states may have been
contaminated with cattle remains in violation of a 1997 ban to
protect against mad cow disease, a manufacturer said Tuesday [20 Jun 2006].

H.J. Baker & Bro. Inc. said it was recalling 3 livestock feed
ingredients, including 2 used to supplement feed given to dairy cows.
A sample tested by the Food and Drug Administration was positive for
cattle meat and bone meal, said Mark Hohnbaum, president of the
Westport, Connecticut-based company's feed products group.

"This is very concerning to us. This isn't something that happens to
us. We are very serious about food safety," Hohnbaum said. Mad cow
disease is only known to spread when cows eat feed containing brain
and other nerve tissue from infected cattle. Protein from cattle was
commonly added to cattle feed to speed growth until the ban largely
outlawed the practice.

Cattle tissue may have contaminated 2 feed ingredients given to dairy
cows -- Pro-Lak and Pro-Amino II -- made by H.J. Baker between August
2005 and June 2006. The 3rd of the recalled ingredients, Pro-Pak with
Porcine Meat and Bone, was mislabeled. It is used in poultry feed.

The company announced the recall in the wake of ongoing FDA
inspections of its Albertville, Alabama plant, Hohnbaum said. The
inspections have found manufacturing and clerical issues, he added.

The company shipped the ingredients to feed manufacturers and dairy
farms in the following states: Alabama, California, Florida, Georgia,
Kentucky, Louisiana, Michigan, Mississippi and Tennessee. The company
is notifying its customers of the voluntary recall. It does not know
how much of the feed ingredients it sold, Hohnbaum said.

On the Net:
Food and Drug Administration animal feed information:
<http://www.fda.gov/cvm/animalfeed.htm>

--
Terry S. Singeltary Sr.
<[email protected]>

[The company is already notifying its customers. Furthermore, the
company does not know how much feed was contaminated, so they are
likely being very cautious and notifying customers, although they may
not have had animals exposed.

It is likely the company does not know how much contamination each
batch of feed received.

Customers should be forewarned that even if an animal consumes some
of this feed, it does not mean it is sure to come down with Bovine
Spongiform Encephalopathy (BSE). It takes a certain amount of
infective material being consumed as well as certain conditions
within the animal for BSE to develop.

What is intriguing about this event is that, though the FDA will fine
the feed manufacturer, on-farm mixing of feed that may contain
prohibited material does not find its way onto the FDA radar screen.
There have been multiple cases of farm-site feed mixing with
confirmation of prohibited material being in the feed, and the feed
being fed to cattle. When this apparent oversight was brought to the
attention of the FDA, the reply was that they [the FDA] did not
believe they had jurisdiction over the farm, only the manufacturers.
Since the FDA could not demonstrate a prion to a court of law, they
did not see how they could prosecute a case of farm-site feed mixing.

Clearly, had the international team that surveyed the situation in
the US during 2004 known of this approach, their recommendations may
well have been different.

Without adherence to the feeding rules, cases of BSE in the United
States will likely continue to occur on a sporadic basis. - Mod.TG]

[see also:
2004
----
BSE, bovine - USA (WA) (16): new regulations 20040318.0747
BSE, bovine - USA: APHIS report 20040205.0426
2003
----
BSE, bovine - USA (WA) (09): new regulations 20031230.3172]
..................tg/msp/mpp

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[flounder]

CJD WATCH MESSAGE BOARD
TSS
FDA Statement on Canadian Rule to Control BSE Risks
Tue Jun 27, 2006 09:27
70.110.82.186


##################### Bovine Spongiform Encephalopathy #####################

FOR IMMEDIATE RELEASE
Statement
June 26, 2006
Media Inquiries:
Rae Jones, 301-827-6242
Consumer Inquiries:
888-INFO-FDA



FDA Statement on Canadian Rule to Control BSE Risks

The Food and Drug Administration (FDA) is aware of the release of a final rule by the Canadian Food Inspection Agency (CFIA) to extend protections in Canada against the risks of bovine spongiform encephalopathy (BSE), so-called Mad Cow disease. The rule is an addition to existing Canadian measures to ban risky ingredients in animal feed -- measures that have provided significant safeguards to protect the health of both United States and Canadian cattle fed animal feed from Canada, and thereby have protected consumers of beef in both countries.

The Canadian approach to BSE prevention is similar to FDA's approach, and the public health agencies of both countries have been in close touch as they have developed their respective regulations. Both countries' BSE feed rules are designed to forestall the spread of the disease and its related human form, variant Creutzfeldt-Jakob Disease, through BSE-infected animal feed. The FDA BSE feed rule, which has been in effect since 1997, has proved its effectiveness as a key component of a tiered firewall against BSE; to date, there have been only three cows found with BSE in the United States, and each of them was either imported, or old enough to have consumed animal feed manufactured before the regulation took effect.

Nevertheless, since the detection of the first BSE-positive cow in the United States, FDA has been actively exploring various ways to further strengthen its existing feed rule which prohibits the use of certain mammalian protein in feed for cattle and other ruminants. Even though the risk of BSE is extremely low, in October 2005, the agency issued a proposed rule that would prohibit the use of certain high risk cattle materials in all animal feed to further reduce an already low probability event. The agency is in the process of analyzing and evaluating the approximately 800 public comments submitted to the FDA about this proposal.

FDA and HHS are committed to continuing to protect animal health and consumers against the spread of BSE through animal feed in the United States . After FDA considers the public comments on the proposal issued in October 2005, the agency and HHS plan to develop and issue a final rule as expeditiously as possible.

####


http://www.fda.gov/bbs/topics/NEWS/2006/NEW01397.html




>>>to date, there have been only three cows found with BSE in the United States, and each of them was either imported, or old enough to have consumed animal feed manufactured before the regulation took effect. <<<


PLEASE NOTE, key word here ''found''.

does not mean that there are many more that they refused to find, considering the terribly flawed USDA june 2004 enhanced BSE cover-up, all of which has been well documented on this list.


>>>The agency is in the process of analyzing and evaluating the approximately 800 public comments submitted to the FDA about this proposal. <<<

>>>The FDA BSE feed rule, which has been in effect since 1997, has proved its effectiveness as a key component of a tiered firewall against BSE<<<


while were all still holding our breath here, the mad cow agent continues to amplify and spread through the USA livestock community via the terribly flawed USDA/FDA BSE 'tiered firewall' and that very recent 9 state recall of feed product containing potential mad cow disease. ...

still disgusted in sunny bacliff, texas


TSS


#################### https://lists.aegee.org/bse-l.html ####################


##################### Bovine Spongiform Encephalopathy #####################

Top Democrat Finds F.D.A.'s Efforts Have Plunged


By GARDINER HARRIS
Published: June 27, 2006
WASHINGTON, June 26 — A 15-month inquiry by a top House Democrat has found that enforcement of the nation's food and drug laws declined sharply during the first five years of the Bush administration.

For instance, the investigation found, the number of warning letters that the Food and Drug Administration issued to drug companies, medical device makers and others dropped 54 percent, to 535 in 2005 from 1,154 in 2000.

The seizure of mislabeled, defective or dangerous products dipped 44 percent, according to the inquiry, pursued by Representative Henry A. Waxman of California, the senior Democrat on the House Government Reform Committee.

The research found no evidence that such declines could be attributed to increased compliance with regulations. Investigators at the F.D.A. continued to uncover about the same number of problems at drug and device companies as before, Mr. Waxman's inquiry found, but top officials of the agency increasingly overruled the investigators' enforcement recommendations.

The biggest decline in enforcement actions was found at the agency's device center, where they decreased 65 percent in the five-year period despite a wave of problems with devices including implantable defibrillators and pacemakers.

"Americans have relied on F.D.A. to ensure the safety of their food and drugs for 100 years," Mr. Waxman said. "But under the Bush administration, enforcement efforts have plummeted and serious violations are ignored."

David K. Elder, the director of the agency's Office of Enforcement, explained that the F.D.A. had increasingly focused on the most serious violations.

"As a result of F.D.A.'s focus on those firms and those violations that present the highest risk to consumers and public health," Mr. Elder said in a statement, "the agency has taken prompt, targeted and aggressive action against firms that are in violation of law."

Jack Calfee, a resident scholar at the conservative American Enterprise Institute, said the decline in the statistics was meaningless because most of the violations involved paperwork problems.

"I doubt that it makes a significant difference in the safety of drugs or other products," Mr. Calfee said.

Mr. Waxman began his inquiry after Congressional hearings in 2004 suggested that the agency was partly to blame for a shortage of flu vaccines. His staff requested thousands of documents from the F.D.A.

The investigation found that by almost every measure, enforcement actions had significantly declined from 2000 to 2005. The lone exception was in the number of products that had to be recalled from the market: that increased 44 percent.

"Since one of the goals of an enforcement system is to deter violations and keep dangerous products off of the market," the report said, "the increase in recalls is not a hallmark of effective enforcement."

In one prominent case, in December 2000, a worker at a nursing home in Xenia, Ohio, mistakenly hooked up a tank of nitrogen gas to the home's oxygen delivery system. Four residents died.

In the months that followed, investigators for the agency concluded that the company that delivered the tanks, BOC Gases, was partly to blame for the mix-up, given what they deemed inadequacy of the company's own controls and employee training. Indeed, BOC had a "corporate-wide problem," F.D.A. documents at the time said. The investigators recommended prosecution, but the agency took no enforcement action.

Kristina Schurr, a spokeswoman for BOC, said that the company's controls had not been to blame but that in any case it had improved its procedures since then.

Several former top officials of the agency attributed the decline in enforcement actions to budget problems.

"This is a tragedy," said Peter Barton Hutt, a former general counsel of the F.D.A. who now represents drug companies and teaches food and drug law at Harvard. "Congress has failed to realize that our single most important government agency is being systematically dismantled."

Dr. Sidney M. Wolfe, director of the Health Research Group at the watchdog organization Public Citizen, noted that the agency now received about $380 million a year in fees from drug makers.

"The public," Dr. Wolfe said, "is getting the kind of F.D.A. that the industry is paying for them to get."


http://www.nytimes.com/2006/06/27/healt ... r=homepage


June 26, 2006, 11:10PM
Study shows drop in enforcement of FDA laws


New York Times

WASHINGTON - An inquiry by a top House Democrat has found that enforcement of the nation's food and drug laws declined sharply during the first five years of the Bush administration.

For instance, the 15-month investigation found, the number of warning letters that the Food and Drug Administration issued to drug companies, medical device makers and others dropped 54 percent, to 535 in 2005 from 1,154 in 2000.

The seizure of mislabeled, defective or dangerous products dipped 44 percent, according to the inquiry, pursued by Rep. Henry Waxman, D-Calif., the senior Democrat on the House Government Reform Committee.

The research found no evidence that such declines could be attributed to increased compliance with regulations. Investigators at the FDA continued to uncover about the same number of problems at drug and device companies as before, Waxman's inquiry found, but top officials of the agency increasingly overruled the investigators' enforcement recommendations. .......... chron.com/


>> >>Date: Wed, 2 Oct 2002 09:04:42 -0700

>>Reply-To: Bovine Spongiform Encephalopathy

>>Sender: Bovine Spongiform Encephalopathy

>>From: Terry S. Singeltary Sr.

>>Subject: MAD COW FEED BAN WARNING LETTERS USA 'update'


>>where, oh where, did all Terry's mad cow feed ban warning letters go$


>> >>FDA Cuts Back on Warnings

>> >>10/01/02

>> >>WASHINGTON -- The Food and Drug Administration has substantially cut

>>back on warnings sent to companies that run afoul of its rules, a move

>>the agency contends will result in more-effective enforcement but that

>>critics say lets violators off the hook.


>> >>The drop results from a policy change in late February that requires the


>>FDA chief counsel's office to clear all warning letters to ensure they

>>are legally sound. Before the change, division and district offices

>>around the country issued such letters unilaterally. In the six months

>>since, the agency issued 279 warning letters, a drop of 64% from the

>>same period last year, a review of agency records shows. The FDA says

>>the chief counsel's office rejected only 6% of the 699 warning letters

>>and other citations it reviewed. At the same time, division and district

>>enforcers may be holding back letters they once would have sent.


>> >>SEE FULL STORY >> >>


http://online.wsj.com/


>> >>snip...


>> >>Date: Wed, 9 Oct 2002 13:21:00 -0700

>>Reply-To: Bovine Spongiform Encephalopathy

>>Sender: Bovine Spongiform Encephalopathy

>>From: Terry S. Singeltary Sr.

>>Subject: 'TONNAGE' OF TAINTED FEED $ what's up with the mad cow warning >> letters >>

>>Greetings, >>

>>since the FDA has apparently stopped issuing some warning letters; >> >>10/7/02 >>

>>Senate Questions FDA Commissioner Nominee

>> >>In testimony today before the U.S. Senate, Dr. Mark McClellan, the Bush

>>administration nominee for Commissioner of Food and Drugs, said that

>>under his leadership, the FDA would uphold its enforcement authority to

>>ensure the safety and effectiveness of the products it regulates and to

>>ensure that accurate and truthful information is conveyed to the public.


>> >>Sen. Edward Kennedy (D-Mass.), chairman of the Senate Health, Education,

>>Labor and Pensions (HELP) Committee, expressed concern at the start of

>>the hearing that the FDA may be backing away from its regulatory

>>authority, noting a drop in the number of Warning Letters issued by the ...


snip... full text


http://www.fda.gov/ohrms/dockets/dailys ... 4be07.html



TSS

 

[Bez?]

flounder

I really do not like it when you post info like this. It is far too difficult to read, and certainly breeds friction between the two countries.

It would be nice if you would have the kindness to perhaps summarize for us illiterate and/or slow reading folk.

In fact despite the politics and the scrapping between the producers on both sides of the border, the average consumer not only has no clue as to the happenings - they well and truly are not interested.

In my opinion there would be far more advancement if the positives were accentuated rather than the "we are better than you" that seems to continually float around on the internet.

There are darned fine ranchers on both sides of the border, but they are often played like musical instruments by the media and various ag groups - and perhaps individuals like you - searching for points and / or dollars.

Bez?

 

[flounder]

bez writes ;

>>>I really do not like it when you post info like this. It is far too difficult to read, and certainly breeds friction between the two countries. <<<


by all means, lets stick our head in the sand and play like everything is o.k., just print the postives??? show me the positives in relations with BSE/TSE regulations in the USA, show me a TSE enhanced surveillance program in the USA that is actually working? and the enforcement of them???


bez writes ;

>>>There are darned fine ranchers on both sides of the border, but they are often played like musical instruments by the media and various ag groups - and perhaps individuals like you - searching for points and / or dollars. <<<

i could not agree with you more, but it is not me that you should be upset with, i am actually on your side. there are no points and or money in this for me. again, i am only vested here by watching for 10+ weeks, everyday, a slow incredibly horrible death of my mother to the Heidenhain Variant of Creutzfeldt Jakob disease. the truth is what drives me, amplification and transmission, and maybe some day we will know the origin. there are farmers and ranchers out there that actually want the truth, they want the data, they want what the federal gov is not telling them. but then, there are others that would rather stick there head in the sand, rubber stamp what the USDA et al are telling them, that the BSE firewalls are working and that there is no problem. but i am not one of those people. i know the truth. i have seen it. it's not pretty.

you have no idea what the USDA et al are capable of doing to a rancher or farmer and or there family. just ask the Faillace's. it is them you should be concerned about, the USDA AND FDA got you in this mess, and they are capable of doing anything to make it look like they are right. anything!


TSS