Readers' Comments

Crystal meth is the most prolific and spreading drug all over the world. Heroin and cocaine now pale in comparison. How will this affect Afghan farmers?

Demand for heroin is already being drastically reduced, since meth costs only a fraction of the time and effort it takes to produce heroin. No plant growing or harvesting is required for meth. It seems to be made by producing chemicals from other chemicals. Again, how will this affect this geopolitical situation?

The Afghan farmers currently see the need to identify another way to make a living. There are certainly powerful forces at work right now working on convincing them to get a new source of income. This happened in the jungles of Peru during the 1980's, where whole villages were recruited to earn comparatively huge sums of money by producing basuco (cocaine paste). This tore some of the villages apart, as there were those who did not want to particpate in this economy. The monetary gain was so much greater than any other opportunity that had come their way, out there in the jungle. It was not only temptation that led many who opposed the use of drugs in their personal lives to take up a relationship with narcotraffickers: because of their access to money, the narcos were able to bribe local officials, who also ended up participating in the production cycle and pressuring those who didn't agree to look the other way.

The entrepreneurial narcotraffickers will continue to undermine attempts by the USA to convert peasants with what amount to non-existent and meager aid totals when held up against the huge and fast profits the little guy can make with various subterranean economies. In addition, the US has upheld the archaic system of empowering only the monied elites in many very poor countries, annointing them the rich from whom all blessings of employment flow. The irony and cynicism, the anger and lack of gratitude, engendered by this historical trend also helps embolden ambitious people with few resources to take advantage of unsanctioned economies.

What can we surmise the Afghani farmers will do for money and food now that heroin will be getting so cheap?

Hi. I work for WWF-Australia and as such have been following this and similar articles in The Australian with great interest.

I just thought it worth mentioning that the claims made in the article you quote are quite misleading, and mischaracterise Greg's comments significantly.

WWF-Australia responded to this article with a press release clearly re-iterating that WWF-Australia does not support nuclear power as solution to climate change. You can find this release at:
http://wwf.org.au/news/wwf-says-nuclear-no-answer-to-climate-change/

In addition, I've posted my personal views on this article, and subsequent articles, on my personal weblog at:

http://www.synapsechronicles.com/archives/2006/05/

See the posts:
* Media beat-ups (May 4)
* Nuclear is no answer to climate change - WWF (May 5)
* What's going on? (May 9)

Lastly, Greg posted a Letter to the Editor in response to a further article Amanda Hodge wrote on May 9. This letter has not (yet) been published by The Australian, but I've posted the text on my weblog here:
http://www.synapsechronicles.com/archives/2006/05/ scroll down to Letter to the editor (May 10)

I hope that this helps to clarify WWF's position and to demonstrate some of the misleading comments made in the article you reference.

Thanks for the opportunity to comment.

Regards, Grant

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

Waste Reduction by Waste Reduction, Inc.
2910-D Fortune Circle West
Indianapolis, IN 46241
Phone: 317.484.4200
Fax: 317.484.4201
www.wr2.net
Comments on FDA Proposed Rulemaking - Docket No. 2002N-0273
From a public health standpoint, we are surprised and concerned that the
FDA would consider disposal of the brain and spinal cord of cattle over 30
months of age, the material it considers the highest risk SRM, through
landfill or incineration (page 44). It has been well demonstrated that there
is no reduction in potential infectivity of BSE contaminated material sent
to
landfill. Incineration of animal material is an extremely inefficient
process;
animal tissues do not make good fuel being 65% to 70% water. Further,
without specifying the conditions of temperature, residence time, and
agitation, there is no control over the efficiency of the proposed
incineration.
The work of Paul Brown at NIH has clearly shown that the infectivity of
prions (in that case 256K scrapie agent) could survive a temperature of
600ºC for 15 minutes, conditions virtually never reached in routine
incinerators. Alkaline hydrolysis at elevated temperature* has been
demonstrated to destroy infectivity even of the most virulent strain of BSE.
i.e., 301V mouse –passaged BSE, and has been included in EU legislation
as a disposal method for all Category 1 material, including known
BSEcontaminated
material.
We agree strongly with FDA’s concerns about cross contamination, not only
between ruminant feed processing lines and SRM destruction lines but also
between clean ruminant feed made from fresh animal and plant material
and ruminant feed contaminated with chicken droppings, non-ruminant feed
that could contain SRM, blood, and other waste products. While the
infectious dose quoted in Reference 13, 0.01gram of brain tissue from a
BSE infected animal, is frightening enough, a report that appeared after the
publication of the proposed rulemaking suggests that the actual infectious
dose may be as little as one-tenth that amount. While these possible
routes of infection of cattle are of serious concern, a potentially more
direct
route of infection of humans has not been adequately considered or
discussed in connection with the banning of SRM from animal feed. It is an
unfortunate fact in this country that many poor people derive their major
protein intake from the eating of pet foods. Thus, the possible inclusion of
SRM in those products could pose a direct threat to human health. The
eating of pet foods by poor people was one of the primary reasons for the
banning from pet foods of material derived from animals euthanized with
barbiturates. SRMs included in per food could pose a similar significant
threat.
We are also uncomfortable with the elimination of the small intestine of
cattle younger than 30 months of age as SRM. Absorption in the small
intestine is the primary route of infection for the prions that cause Bovine
Spongiform Encephalopathy and it has been demonstrated that these
Waste Reduction by Waste Reduction, Inc.
* In the spirit of full disclosure, it must be noted that WR2 is the
developer of the Alkaline Hydrolysis
Process and the manufacturer of Tissue Digestors™ for the use of the
Process.
agents can localize and reproduce in the lymph nodes of the intestine
before they travel to the central nervous system. For that reason, we
believe that the small intestine of all cattle, or, at least, the terminal
ileum of
all cattle, even those younger than 30 months of age, should be designated
as SRM and removed from the human and animal food chains. While we
realize that this would significantly increase the amount of SRM that
needed to be destroyed, we also believe that the necessary infrastructure
for that destruction, using scaled-up versions of current alkaline
hydrolysis
technology, could rapidly be deployed either as fixed-base plants or as
large-scale mobile systems. While some of the numbers quoted in the
discussion section of the proposed rulemaking for the amount of SRM to be
generated seem very large, efficient use of as few as 100 alkaline
hydrolysis systems capable of processing 20,000 pounds per cycle and as
few as only three cycles per day could process the 2 billion pounds per year
reported on page 25 of the proposed rulemaking.
We must also question the cost estimates for disposal made by ERG. No
specific estimate for any of the proposed disposal methods is presented;
rather, a lump sum “low-end” estimate is given with no relation to any
method. We do not know how they derived any figures on the cost of
alkaline hydrolysis for their analysis as they did not contact us or, to the
best of our knowledge, any of the sites currently using large volume Tissue
Digestors™. Operating costs for these Digestors (not including labor and
amortization of capital equipment) range between $2.5 per 100 lbs and $4
per 100 lbs, far less than the $12 average cited. Further, considering that
the ERG survey had to have been made some months before the
publication of the proposed rulemaking, it could not have taken into account
the dramatic increase in natural gas costs to fuel the proposed incinerator
disposal pathway. Thus, even the apparently high estimates presented that
must include this as, perhaps, the primary disposal pathway are probably
much too low under present circumstances.
In summary, although we accept that the proposed rulemaking may be an
improvement over the present unregulated situation with regard to the use
of SRM in animal feeds, we do not believe it is inclusive enough nor goes
far enough. We believe the original proposal from FDA would provide
significantly greater protection of public health than the currently
proposed
regulation.

http://www.fda.gov/OHRMS/DOCKETS/dockets/02n0273/02n-0273-EC232-Attach-1.pdf

tss

----- Original Message -----
From: "Terry S. Singeltary Sr."
To:
Sent: Monday, May 01, 2006 5:01 PM
Subject: Medical Waste and CJD 2003 guidelines CDC

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

Medical Waste and CJD 2003 guidelines CDC ?
Mon May 1, 2006 16:56
71.248.145.247

Managing Fluid Disposal
Part I of II
By Kathy Dix

Operating room (OR) personnel are frequently overwhelmed by their numerous
responsibilities of not only “fixing” the patient, but also preventing
infection, maintaining a sterile field, utilizing only sterile instruments,
and in general, ensuring the patient’s safety, as well as that of the OR
staff. Proper fluid management is one of those crucial steps to preserving
the wellbeing of both staff and patient.

Has your OR personnel been trained in the disposal of liquid waste? Are they
aware of state and/or city regulations? Is their bloodborne pathogen
training recent? Is annual competency testing required?

snip...

Of special interest, APIC’s guidelines also point out the more recent
anxiety related to Creutzfeldt-Jakob disease (CJD). “Concerns also have been
raised about the need for special handling and treatment procedures for
wastes generated during the care of patients with CJD or other transmissible
spongiform encephalopathies (TSEs),” the guidelines observe. “Prions, the
agents that cause TSEs, have significant resistance to inactivation by a
variety of physical, chemical, or gaseous methods. No epidemiologic
evidence, however, links acquisition of CJD with medical-waste disposal
practices. Although handling neurologic tissue for pathologic examination
and autopsy materials with care, using barrier precautions, and following
specific procedures for the autopsy are prudent measures, employing
extraordinary measures once the materials are discarded is unnecessary.
Regulated medical wastes generated during the care of the CJD patient can be
managed using the same strategies as wastes generated during the care of
other patients. After decontamination, these wastes may then be disposed in
a sanitary landfill or discharged to the sanitary sewer, as appropriate.”1

http://www.infectioncontroltoday.com/articles/651feat3.html

Guidelines for Environmental Infection Control

in Health-Care Facilities

Recommendations of CDC and the Healthcare Infection Control

Practices Advisory Committee (HICPAC)

U.S. Department of Health and Human Services

Centers for Disease Control and Prevention (CDC)

Atlanta, GA 30333

2003

snip...

6. Medical Waste and CJD

Concerns also have been raised about the need for special handling and
treatment procedures for wastes

generated during the care of patients with CJD or other transmissible
spongiform encephalopathies

(TSEs). Prions, the agents that cause TSEs, have significant resistance to
inactivation by a variety of

physical, chemical, or gaseous methods.1427 No epidemiologic evidence,
however, links acquisition of

CJD with medical-waste disposal practices. Although handling neurologic
tissue for pathologic

examination and autopsy materials with care, using barrier precautions, and
following specific

117

procedures for the autopsy are prudent measures,1197 employing extraordinary
measures once the

materials are discarded is unnecessary. Regulated medical wastes generated
during the care of the CJD

patient can be managed using the same strategies as wastes generated during
the care of other patients.

After decontamination, these wastes may then be disposed in a sanitary
landfill or discharged to the

sanitary sewer, as appropriate. .........

snip...

http://www.apic.org/AM/Template.cfm?Section=Search§ion=CDC1&template=/CM/Con
tentDisplay.cfm&ContentFileID=342

VARIANT CREUTZFELDT-JAKOB DISEASE (vCJD) and BLOOD

COMPONENTS

INFORMATION FOR PATIENTS, February 2006

http://www.hpa.org.uk/infections/topics_az/cjd/BC-InfoforP.pdf

http://www.hpa.org.uk/infections/topics_az/cjd/frameworkannex1-Aug2005.pdf

© 2006 American Society for Investigative Pathology

Detection and Localization of PrPSc in the Skeletal Muscle of Patients with
Variant, Iatrogenic, and Sporadic Forms of Creutzfeldt-Jakob Disease
Alexander H. Peden, Diane L. Ritchie, Mark W. Head and James W. Ironside
From the National Creutzfeldt-Jakob Disease Surveillance Unit and Division
of Pathology, School of Molecular and Clinical Medicine, University of
Edinburgh, Western General Hospital, Edinburgh, United Kingdom

Variant Creutzfeldt-Jakob disease (vCJD) differs from other human prion
diseases in that the pathogenic prion protein PrPSc can be detected to a
greater extent at extraneuronal sites throughout the body, principally
within lymphoid tissues. However, a recent study using a high-sensitivity
Western blotting technique revealed low levels of PrPSc in skeletal muscle
from a quarter of Swiss patients with sporadic CJD (sCJD). This posed the
question of whether PrPSc in muscle could also be detected in vCJD, sCJD,
and iatrogenic (iCJD) patients from other populations. Therefore, we have
used the same high-sensitivity Western blotting technique, in combination
with paraffin-embedded tissue blotting, to screen for PrPSc in muscle tissue
specimens taken at autopsy from 49 CJD patients in the United Kingdom. These
techniques identified muscle PrPSc in 8 of 17 vCJD, 7 of 26 sCJD, and 2 of 5
iCJD patients. Paraffin-embedded tissue blotting analysis showed PrPSc in
skeletal muscle in localized anatomical structures that had the
morphological and immunohistochemical characteristics of nerve fibers. The
detection of PrPSc in muscle tissue from all forms of CJD indicates the
possible presence of infectivity in these tissues, suggesting important
implications for assessing the potential risk of iatrogenic spread via
contaminated surgical instruments.

http://ajp.amjpathol.org/cgi/content/abstract/168/3/927

SEAC 2006

21. Dr Matthews noted that data are now available on the infectivity of

a wide range of bovine tissues. In September 2005, the World

Health Organisation had updated its assessment of the risk of TSE

infectivity in tissues. These data, although incomplete, should

increase confidence in the safety of particular tissues, particularly if

the age of the source animal is also considered. As a result, less

reliance need now be placed on the status of the country of origin.

Members agreed, but noted that it would be important to assess

the quality of the data on which assessments are based. As it

seems highly likely that blood, at least from humans infected with

vCJD, can be infectious, tissues and organs with a significant

blood supply may also confer higher risk.

http://www.seac.gov.uk/minutes/draft-91.pdf

THE ENVIRONMENTAL RISK FACTORS FOR TSE ARE STILL UNKNOWN, but from recent
science coming out lately, the risk factor seems to be increasing, rather
than decreasing.

CAN SOMEONE PLEASE EXPLAIN TO ME WHY IT IS STILL ACCEPTABLE FOR sanitary
landfill or discharged to the sanitary sewer, as appropriate FOR CJD, when
the epidemiology of all phenotypes of sporadic CJDs are not known to date,
and with apparent new ones of 'unknown' origin being documented as we
speak???

http://www.cjdsurveillance.com/resources-casereport.html

THE practice of landfilling and or the discharging to the sanitary sewer,
and or spreading to land as fertilizer of any human and or animal TSE should
be banned immediately. ...TSS

TSS

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

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

Hey, this is a good development and the channel sure believes that everything for public service should be a la open
source. However since it is free programming, there could a question mark on the programmes run by corporates and whether it is a substitute for advertising.

In India we have controversies over particular media houses accepting paid editorials and stuff. Thus the editorial guides of Green TV need to be highlighted well I suppose. Nevertheless, it's still good news for PR guys.

Wonder Green TV accepts films from Indian corporates.

Hobbit from http://indiapr.blogspot.com

O'Dwyer's has run [http://www.odwyerpr.com/members/0504lincoln.htm a clarification] of its earlier Lincoln Group article:

[Lincoln Group co-founder Paige] Craig said the LG staffer who told O'Dwyer's that Bill Dixon has left his media relations post was wrong. "He is still with the company," said Craig.

Laurie Adler, whom Craig said handled internal marketing communications duties, has departed the firm.

The main subject of the follow-up article, though, is a Cinco de Mayo party being held by Paige Craig: "The invitation recalls how a French army invaded Mexico in 1862 to collect debt and contribute to the Confederate cause. ... LG's party is to celebrate freedom, liberty and the beginning of France's decline as a world power."

The article goes on to state:

Craig said LG has "changed its attitude," and is now more open with the press. Part of that reasoning is due to the confusion about what LG does. Craig described the firm as "client-driven," and the new transparency is what LG's clients want.

Our books our currently published by Penguin, and indeed they use marketing techniques to advertise and publicize the books. All profits and proceeds from the sale of our books go to the non-profit Center for Media and Democracy where Sheldon Rampton and I work.

http://www.prwatch.org/node/4777

Check out the KGO TV piece above about [[Rick Berman]], the lobbyist who runs [[ActivistCash]] and whom PR exec Kevin Foley finds so credible. KGO TV is the ABC affiliate in San Francisco, CA. This is a great example of a TV station actually engaged in journalism, exposing [[ActivistCash]] and [[Rick Berman]] as industry shills and fronts. KGO could have saved itself thousands and thousands of dollars and avoided offending powerful interests such as the corporations that fund [[ActivistCash]] and [[Berman and Co.]] by NOT doing this story, and instead running one of the corporate-funded fake news stories that Kevin Foley provides stations for free. Hats off to KGO for real journalism in this case.

I'm curious as to why the VNR referenced as having been aired by KTVI in St. Louis is a problem. It was a lifestyles package on Halloween candy and safe Halloween practices.

Do we think enterprising TV reporters would have uncovered a huge Halloween conspiracy where Snickers and 1-800-FLOWERS were teaming up to brainwash all the little tykes? Divert all resources, boys -- we're taking these Satanic bastards down!

I understand the issues with the arthritis cure and such ... but pick your battles, people.

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

BSE on the rise in Poland

By staff reporter

28/04/2006 - Poland has confirmed a new case of BSE in one of its cows, as figures suggest the disease has crept forward in the country amid a rapid fall in outbreaks elsewhere in the world.

Poland's agriculture ministry said its routine sampling procedure had found a further case of mad cow disease in the country's Lodz province.
Veterinary authorities said they had begun investigating how the cow became infected.

The news shows how BSE, known in full as Bovine Spongiform Encepalopathy, continues to be a thorn in Poland's side as it works to improve food safety and quality standards.

Recent figures from the World Organisation for Animal Health, show that cases of BSE in Poland have been increasing over the last few years. The country reported no outbreaks between 1989 and 2000, but cases have crept up from four in 2001 to 19 last year.

The figures also found BSE cases rising, albeit on a small scale, in the Czech Republic and Slovakia. The Czech Republic confirmed eight cases last year, compared to two in 2001.

The trend is something food safety watchdogs in Eastern Europe will be wary of amid reports of dramatic drops in BSE cases elsewhere in the world.

The number of BSE-infected cows fell by 50 per cent in 2005 compared to 2004, according to the Food and Agriculture Organisation (FAO) of the United Nations, which worked closely with the World Organisation for Animal Health to compile its report.

The FAO said just 474 animals died of BSE around the world, compared with 878 in 2004 and 1,646 in 2003, and against a peak of several tens of thousands in 1992.

“It is quite clear that BSE is declining and that the measures introduced to stop the disease are effective," stated Andrew Speedy, an FAO animal production expert. "But further success depends on our continuing to apply those measures worldwide.”

European consumption of beef has slowly been rising as public fears have diminished. For the first time in 20 years consumption of beef and veal surpassed EU production in 2003 and is expected to grow further by 2012, according to a recent forecast report by the European Commission.

http://www.cee-foodindustry.com/news/ng.asp?id=67381

MY POINT EXACTLY...TSS

----- Original Message -----
From: Terry S. Singeltary Sr.
To: news@ens-news.com
Cc: christopher.matthews@fao.org
Sent: Tuesday, March 28, 2006 5:41 PM
Subject: re-Mad Cow Disease Dying Out Worldwide

Greetings,

In reply to the statement made by the FAO AND OIE;

Mad cow disease on the wane worldwide
Rapid rate of decline encouraging
23 March 2006, Rome - Cases of Bovine Spongiform Encepalopathy (BSE) or “mad cow disease” worldwide are declining, according to the UN Food and Agriculture Organization (FAO). They have been dropping at the rate of some 50 percent a year over the past three years, the Organization said today.

Amid the current international alarm over avian flu, it is good news that the battle against another worrying disease is being won.

In 2005, just 474 animals died of BSE around the world, compared with 878 in 2004 and 1646 in 2003, and against a peak of several tens of thousands in 1992, according to figures collected by the Paris-based World Animal Health Organization (OIE), with which FAO works closely.

Only five human deaths resulting from variant Creutzfeldt-Jakob Disease (vCJD), believed to be the human form of BSE, were reported worldwide in 2005. All of them were in the United Kingdom – the country most affected by the disease – where nine deaths were registered in 2004 and 18 in 2003. ...

http://www.fao.org/newsroom/en/news/2006/1000258/index.html

'Mad Cow Disease Dying Out Worldwide'
http://www.ens-newswire.com/ens/mar2006/2006-03-28-02.asp

I would kindly like to reply;

I find this statement to be without any merit at all. HOW can one conclude that BSE or other TSEs are dying out worldwide, when the surveillance of BSE/TSE to any creditable extent is only practiced in EU states and Japan. NO one knows the true extent in these other countries where a surveillance system for BSE/TSE has never been enforced. For example, in North America alone, the USDA et al have no idea what the true extent of the BSE/TSE are in the USA cattle population. ONE needs to look no further than the State of Texas and what has happened there time and time again with BSE in cattle. The first 500,000 test of the infamous June 2004 Enhanced BSE surveillance program was terribly flawed from the beginning, and proven to be so, with flawed BSE testing protocol with the IHC testing minus WB confirmation. THESE tests were meaningless and should be done over. HOW can one lay claim to mad cow dying out worldwide, when some countries have never even had a documented surveillance system for BSE/TSE set up? I find this report by the FAO and the OIE, which by the way, whos regulations of BSE failed us terribly to begin with, and continue to fail us today, especially by accepting the 'Minimal Risk Region' regulations the USA started, once the USA documented there first case of BSE. One only has to look at the countries that followed the BSE guidelines by the OIE, most of which all came down with BSE even after following the flawed protocol of the OIE. This report is terribly misleading and in fact in my opinion, it is FALSE, should be retracted and corrected with the truth. The truth is, BSE has been reduced greatly in most all EU countries that have indeed followed the ruminant to ruminant feed ban, cross contamination guidelines, etc. but they have no idea about the rest of the world, especially the USA and all of North America. This agent goes much further than the ukbsenvcjd only theory leads you do to believe. The USA is infected with CWD in deer and elk, scrapie in sheep and goats to a lesser extent, and TME in mink, besides the TSE i.e. BSE they have documented in the USA bovine, but what about atypical TSEs? (please see references below)

Thank you,
kind regards,

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

SOURCE ............SNIP..........END................TSS

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

BSE GBR ASSESSMENTS

http://www.efsa.eu.int/science/tse_assessments/gbr_assessments/catindex_en.html

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of the United States of America (USA)
Last updated: 19 July 2005
Adopted July 2004 (Question N° EFSA-Q-2003-083)

Report
Summary
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.

Publication date: 20 August 2004

http://www.efsa.eu.int/science/tse_assessments/gbr_assessments/573_it.html

http://www.efsa.eu.int/science/tse_assessments/gbr_assessments/573/sr03_biohaz02_usa_report_summary_en1.pdf

http://www.efsa.eu.int/science/tse_assessments/gbr_assessments/573/sr03_biohaz02_usa_report_v2_en1.pdf

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of Mexico

Adopted July 2004 (Question N° EFSA-Q-2003-083)

[Last updated 08 September 2004]

http://www.efsa.eu.int/science/tse_assessments/gbr_assessments/565/sr04_biohaz02_mexico_report_v2_en1.pdf

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of the United States of America (USA)

Adopted July 2004 (Question N° EFSA-Q-2003-083)

[Last updated 08 September 2004]

http://www.efsa.eu.int/science/tse_assessments/gbr_assessments/573/sr03_biohaz02_usa_report_v2_en1.pdf

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of Canada

Adopted July 2004 (Question N° EFSA-Q-2003-083)

[Last updated 08 September 2004]

http://www.efsa.eu.int/science/tse_assessments/gbr_assessments/564/sr02_biohaz02_canada_report_v2_en1.pdf

4. Professor Richard Marsh has recently described an outbreak of TME in which
the owner routinely fed cattle material (DEAD STOCK) to mink but claimed
NEVER to have fed sheep material. This raises a theoretical possibility that sheep
(and goats) may not be the only animal reservoir of scrapie-like agents...

full text;

a review of research work at home and abroad

http://www.bseinquiry.gov.uk/files/mb/m11c/tab01.pdf

1994 UK EXPORTS BEEF VEAL USA , MEXICO $ CANADA ONLY
other Countries list in PDF file)

USA -------- TOTALS ''8'' TONS
CANADA -- TOTALS ''29'' TONS

1995 UK EXPORT BEEF AND VEAL TO USA AND CANADA

USA ------- TOTALS ''358'' TONS

CANADA --TOTALS ''24'' TONS

BONE-IN BEEF AND VEAL

USA-------- TOTALS ''10'' TONS (i think this is part of the 358 tons
above?)

UK EXPORT OF LIKE CATTLE TO USA AND CANADA

1986 TO 1996 USA TOTAL = 1297

1986 TO 1996 CAN TOTAL = 299

http://www.bseinquiry.gov.uk/files/mb/m11f/tab10.pdf

UK EXPORT MEAT OR OFFAL OF BOVINE ANIMALS DEC 1987

CANADA -- 64,526 KG

UK EXPORT OFFALS OF BOVINE ANIMALS FRESH CHILLED
OR FROZEN OTHER THAN LIVER DEC 1987 YTD

USA -- 45,943 KG

UK EXPORT MEAT OF BOVINE ANIMAL WITH BONE IN 1988

CANADA -- 4,163 KG

PREP OR PRES MEAT OR OFFAL OF BOVINE ANIMALS CUMULATIVE
TO DEC 1988

USA -------- 28,609 KG
CANADA -- 22,044 KG

MEAT OF BOVINE ANIMALS WITH BONE IN CUMULATIVE TO ANUAL 1989

USA -------- 17,880 KG
MEXICO---- 33,444 KG

BONELESS MEAT OF BOVINE 1989

USA --------111,953 KG
CANADA---1,800 KG
MEXICO --- 1,143,387 KG

EDIBLE OFFAL OF BOVINE ANIMALS 1989

USA -------- 19,980 KG
MEXICO--- 31,244 KG

MORE........

MEAT OF BOVINE ANIMALS BONELESS 1990

USA 146,443

http://www.bseinquiry.gov.uk/files/mb/m11g/tab05.pdf

UK EXPORTS MBM AROUND GLOBE

http://www.bseinquiry.gov.uk/files/mb/m11g/tab05.pdf

Oversight of FSIS Recalls

For the past several years we have testified about our continuing work regarding adulterated beef product recalls. In July 2004, a Pennsylvania firm initiated a recall of approximately 170,000 pounds of ground beef patties because of mislabeling. Approximately one-fourth of this product was made, in part, from beef trim from Canada which was not eligible for import to the U.S., following the detection of a Canadian cow with BSE.

http://appropriations.house.gov/_files/FongTestimony.pdf

look on page 44 and up here about the Texas cow also;

Rigid Protocols Reduced the Likelihood BSE Could be Detected

APHIS relied on a single test method, as well as a histological examination of tissue for lesions consistent with BSE, to confirm the presence of BSE even though discrepant test results indicated further testing may be prudent. When IHC test results were interpreted as negative, APHIS concluded the sample tested negative for BSE. Subsequent independent tests initiated by OIG using a different testing method, as well as confirmatory testing by Weybridge, determined that the suspect sample was a positive case of BSE.

When the tissue sample originally arrived at NVSL in November 2004 from the contract lab, NVSL scientists repeated the ELISA screening test and again produced three high positive reactive results. NVSL scientists cut out two sections of the brain sample for IHC testing. One section was used for an experimental procedure that was not part of the confirmatory testing protocol, and the other cut was for normal IHC testing using scrapie for a positive control.47 According to NVSL scientists, the experimental test results were inconclusive but the IHC test was interpreted as negative. The NVSL scientists were concerned with the inconsistencies and conducted

APHIS Declares BSE Sample Negative Despite Conflicting Results

snip.......see full text;

http://www.usda.gov/oig/webdocs/50601-10-KC.pdf

-------- 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: <419E14E2.5040104@wt.net> <6.0.0.22.2.20041119113601.02682730@tahc.state.tx. 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: <419E14E2.5040104@wt.net>

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: <419E14E2.5040104@wt.net> <6.0.0.22.2.20041119113601.02682730@tahc.state.tx. us> <41A2724F.3000901@wt.net> <6.0.0.22.2.20041122174504.02796d38@tahc.state.tx. us> <41A27EBC.4050700@wt.net>

our computer department was working on a place holder we could postUSDA's announcement of any results. There are no results to be announced tonightby 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.>>>>>>==========================
==========================

Oversight of FSIS Recalls

For the past several years we have testified about our continuing work regarding adulterated beef product recalls. In July 2004, a Pennsylvania firm initiated a recall of approximately 170,000 pounds of ground beef patties because of mislabeling. Approximately one-fourth of this product was made, in part, from beef trim from Canada which was not eligible for import to the U.S., following the detection of a Canadian cow with BSE.

http://appropriations.house.gov/_files/FongTestimony.pdf

look on page 44 and up here about the Texas cow also;

Rigid Protocols Reduced the Likelihood BSE Could be Detected

APHIS relied on a single test method, as well as a histological examination of tissue for lesions consistent with BSE, to confirm the presence of BSE even though discrepant test results indicated further testing may be prudent. When IHC test results were interpreted as negative, APHIS concluded the sample tested negative for BSE. Subsequent independent tests initiated by OIG using a different testing method, as well as confirmatory testing by Weybridge, determined that the suspect sample was a positive case of BSE.

When the tissue sample originally arrived at NVSL in November 2004 from the contract lab, NVSL scientists repeated the ELISA screening test and again produced three high positive reactive results. NVSL scientists cut out two sections of the brain sample for IHC testing. One section was used for an experimental procedure that was not part of the confirmatory testing protocol, and the other cut was for normal IHC testing using scrapie for a positive control.47 According to NVSL scientists, the experimental test results were inconclusive but the IHC test was interpreted as negative. The NVSL scientists were concerned with the inconsistencies and conducted

APHIS Declares BSE Sample Negative Despite Conflicting Results

snip.......see full text;

http://www.usda.gov/oig/webdocs/50601-10-KC.pdf

-------- 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: <419E14E2.5040104@wt.net> <6.0.0.22.2.20041119113601.02682730@tahc.state.tx. 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: <419E14E2.5040104@wt.net>

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: <419E14E2.5040104@wt.net> <6.0.0.22.2.20041119113601.02682730@tahc.state.tx. us> <41A2724F.3000901@wt.net> <6.0.0.22.2.20041122174504.02796d38@tahc.state.tx. us> <41A27EBC.4050700@wt.net>

our computer department was working on a place holder we could postUSDA's announcement of any results. There are no results to be announced tonightby 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.>>>>>>==========================
==========================

OH SHIT< bingo, bet this is what you are seeking mike;

Report on Food & Drug Administration Dallas District Investigation of
Bovine Spongiform Encephalopathy Event in Texas 2005

Executive Summary:

On June 24, 2005, USDA informed FDA that a cow in Texas tested positive for Bovine Spongiform Encephalopathy (BSE). Information provided by APHIS was that the BSE positive cow was born and raised in a herd in Texas and was approximately 12 years old. The animal was sampled for BSE at a pet food plant in Texas on November 15, 2004, as part of USDA’s enhanced surveillance program. The animal was disposed of by incineration and did not enter the human food or animal feed chains. Although the positive animal posed no risk to the animal feed supply, FDA, APHIS, the Texas Animal Health Commission (TAHC), and the Texas Feed and Fertilizer Control Service (TFFCS) conducted a feed investigation with two main objectives. The first objective was to identify all protein sources in the animal’s feed history that could potentially have been the source of the BSE agent. The second objective was to verify that cattle leaving the herd after 1997 that were identified by USDA/APHIS as animals of concern (e.g. progeny and feed cohorts), were rendered at facilities in compliance with the regulation (21 CFR 589.2000) that prohibits most mammalian protein in feed for ruminants that became effective August 4, 1997 (herein called BSE/Ruminant Feed rule).

The feed history investigation identified 21 feed products that had been used on the farm since 1990. These feed products were purchased from three retail feed stores and had been manufactured at nine different feed mills. The investigators visited these establishments to collect information on formulations, shipping invoices, and use of ruminant meat and bone meal (MBM) on the premises both pre-1997 feed ban and post-1997 feed ban. This investigation found no feed products used on the farm since 1997 that had been formulated to contain prohibited mammalian protein.

The investigation identified one feed which contained an animal protein source that could not be identified. The investigation also found one feed mill that supplied feed to the farm that had used ruminant MBM in feed formulations for non-ruminant species after the BSE/Ruminant Feed rule went into effect, which is permitted under the rule, and that several feed mills had used ruminant MBM in feeds prior to the feed ban. Although the investigation did not identify a specific feed source as the likely cause of this animal’s infection, it is probable that the most likely route of exposure for this animal was consumption of an animal feed containing mammalian protein prior to the implementation of the BSE/Ruminant Feed rule in 1997.

The investigation into the disposition of herd mates from this farm involved visits to nine slaughter plants and eight rendering plants. The investigation found that all rendering plants were operating in compliance with the BSE/ruminant feed ban regulation. A review of the inspection history of each of these rendering firms found no violations.

Background of Investigation:

When notified on June 24, 2005, FDA Headquarters and Dallas District management officials immediately began making contacts with their Federal, State and Local counterparts to plan for and initiate follow-up investigational activities to determine the feed history in this herd and to assure the safety of the animal feed supply by evaluating current and historic compliance with the BSE/ruminant feed ban rule.

APHIS established a joint Incident Command Post and FDA Dallas District staffed this post full time with a Supervisory Investigator charged with coordinating activities between FDA, APHIS, TAHC and TFFCS. Coordination conference calls were set up with all Federal and State agencies involved in the investigation to keep everyone apprised of investigational developments.

Animal Tracing Activities and Renderer Follow-up Inspections:

One of APHIS’ primary objectives was to identify and trace the animals of interest (animals of interest would include any animals which could have been potential birth cohorts or feed cohorts of the index animal, or potential offspring of the index animal within the two years prior to the positive diagnosis) from the index herd. This objective included the identification of points of sale and ultimately the actual slaughter facilities for animals of interest that left the farm. As the trace information was developed, APHIS shared this information with FDA. Further information on animal of interest identification and tracing can be found in the USDA Texas BSE Final Epidemiology report.

APHIS identified nine slaughter establishments receiving these animals of interest. Eight of the slaughter establishments were located in the State of Texas and one was located in the State of Georgia. Dallas District Investigators notified USDA/FSIS of our plans to visit each slaughter establishment to identify rendering facilities receiving materials from these slaughter establishments during the timeframe they received animals of interest. Dallas District also issued an assignment to Atlanta District to visit and inspect the one slaughter/renderer establishment located in the State of Georgia.

Eight renderers and one protein source broker were identified as receiving materials from these slaughter establishments. Each rendering facility identified was inspected for current compliance with the mammalian protein feed ban rule. Each firm’s operations during the period of time of receipt of these animals post 1997 were evaluated from a historical viewpoint and no evidence of noncompliance was detected.

In all, FDA visited nine slaughter facilities, eight rendering facilities and one broker of these materials. All facilities inspected were found to be in compliance with the BSE/ruminant feed ban rule

Feed Investigation:

As information was learned about the index herd, FDA Investigators working with TAHC officials conducted multiple interviews with the producer of the animal regarding possible feeds, feed sources, animal husbandry practices, and other events which may have changed normal feeding practices over the course of the index animal’s life in the herd and any other information which may have been helpful in identifying the possible sources of feed for this animal and herd. FDA corroborated this information through interviews at the retail feed supply stores where the producer purchased feeds.

Follow-up at these retail feed supply stores identified 21 possible feed products the producer may have used during the history of the herd. Fifteen purchased feed products were identified, along with hay, native grass, rice straw, soybean meal, milk replacer/colostrum and bagged corn. These products were identified as originating from nine different manufacturers. Each of these manufacturers was inspected by FDA Dallas District and TFFCS Investigators.

Feed manufacturers were located throughout the State of Texas. An assignment was also issued to another FDA District to visit a Corporate Headquarters facility in an effort to review archived feed formulations and labels. During each of these inspections, the firm’s current compliance with the BSE/ruminant feed ban rule was evaluated and attempts were made to determine the protein sources used in feeds on the index farm. Many of the feeds investigated were manufactured and used prior to the implementation of the BSE/ruminant feed ban rule in 1997. Feed products of particular interest included any which may have contained a protein source and the primary focus was on identifying any possible mammalian protein source material in those feed products. We found that ruminant feeds that had contained mammalian meat and bone meal (MBM) prior to the BSE/ruminant feed ban rule had been discontinued or reformulated upon the implementation of these rules. There is no regulatory requirement for a feed mill to archive formulations for that length of time, so in those instances where an actual formulation could not be obtained, experienced employees of the firms were interviewed and their recollections recorded.

Of all the feeds in use by the producer since 1997, none were discovered to have contained prohibited material (mammalian protein). Since the age of the index animal was determined to be approximately 12 years, investigating and reconstructing a feed history over such a long period of time is challenging. This ranch is a beef cow-calf operation and minimal feed records were maintained. Due to the nature of this investigation, it is difficult to determine what feeds were in use at specific times and what the formulation of those feeds were at the time they were fed. A feed history was developed through interviews with the producer and other farm personnel since they did not maintain any feed history documentation. Interviews with personnel at retail establishments disclosed incomplete records and cash sales that did not always identify the purchaser. Dallas District investigated any and all feed ingredients that were identified as being fed or potentially fed over the course of the last 15 years of this herd’s operation. Feeds discovered during this investigation with potential mammalian protein sources are as below:

One feed, used prior to 1996, before the implementation of the feed ban, was suspected to contain mammalian meat and bone meal, but this could not be confirmed as no formulation records were available.

The producer recalled using a particular feed sporadically during the 1980’s and 1990’s, however, he could not remember the name or manufacturer of the feed and had no records identifying the product. It is not known whether this feed contained an animal protein source. Attempts to identify this feed through interviews with retail sources were unsuccessful.

The producer identified one feed product that has been used since the year 2000 which contains fish meal as a protein source. Further investigation revealed that this product had contained mammalian meat and bone meal prior to 1997, but that it had been reformulated at that time using fish meal to replace the MBM.

A tabular representation of the feed inspection follow-up activities is presented below:

Feed
Dates of Use
Protein Source
Current BSE Inspection
BSE Compliance History

Feed #1 - Range Meal
1980’s - 2000
Unknown - Unable to determine actual manufacturer, no records available from producer
N/A
N/A

Feed #2 - High Protein Starter Feed
2001 to present
Feather meal
BSE Compliant
BSE Compliant

Feed #3 - High Protein Starter Feed
~1995 - 2001
Feather meal
BSE Compliant
BSE Compliant

Feed #4 - Cottonseed cake
Prior to 1990
Cottonseed meal
BSE Compliant
BSE Compliant

Feed #5 - Cottonseed cake
Early 1980’s - 1990’s
Cottonseed meal
BSE Compliant
BSE Compliant

Feed #6 - Limiter
2001 to present
Feather meal
BSE Compliant
BSE Compliant

Feed #7 - Creep pellets
Prior to 1970
Likely feather meal - no formulation could be obtained
N/A
N/A

Feed #8 - Lick tub
Since 2000
MBM prior to 1997 Fish Meal since 1997
BSE Compliant
BSE Compliant

Feed #9 - Cottonseed meal
Continuously
Cottonseed meal
BSE Compliant
BSE Compliant

Feed #10 - Range Cubes
Continuously since 1990
Feather meal
BSE Compliant
BSE Compliant[1]

Feed #11 - Sulfur Salt Block
Continuously
Minerals; calcium - all non-animal derived
BSE Compliant
BSE Compliant

Feed #12 - Lick tub
Continuously since 1995
Feather meal
BSE Compliant
BSE Compliant

Feed #13 - Beef Supplement
Prior to 1996
Prior to 1997, suspect MBM - Not able to confirm, no formulation available
BSE Compliant
Same manufacturer as Feed #10[1]

Feed #14 - Mineralized Salt
Continuously since 1998
Minerals; calcium - all non-animal derived
BSE Compliant
BSE Compliant

Feed #15 - Soybean meal
Since 2000, sparingly
Soybean meal
N/A
N/A

Feed #16 - Corn
Continuously
Corn
N/A
N/A

Feed #17 - Rice straw
1996, during dry year
Rice straw
N/A
N/A

Feed #18 - Hay
Continuously
Hay
N/A
N/A

Feed #19 - Milk Replacer
Since 2000, Infrequent use
Dehydrated colostrums, whey
N/A
N/A

Feed #20 - Grass
Continuously
Native grass
N/A
N/A

Feed #21 - Soybean meal
Since 2000, sparingly
Soybean meal
N/A
N/A

[1] Dallas District previously documented one incident of the accidental addition of mammalian protein to a feed that was to be used for cattle at this facility. This incident was isolated to the manufacture of one lot of a custom cattle feed. A cross contamination error resulted in mammalian meat and bone meal being accidentally included in a feed. The error was detected soon after production. The firm acted swiftly in recalling the product and purchasing the animals that had consumed the feed. No products entered the human food or ruminant feed chain.

Dallas District Compliance History with BSE Feed Ban Rules:

Prior to 1997, feed manufacturers were not required to differentiate between protein sources used in ruminant and non-ruminant feeds. For a period of time following the implementation of the BSE/ruminant feed ban rule, some feed manufacturers continued to use both prohibited material and non-prohibited material within the same facility, employing separation and cleanout procedures to minimize cross-contamination. Although the regulations allow this practice, the potential for cross-contamination of ruminant feeds is greater. Most feed mills have found this practice to be difficult and have abandoned this practice.

Since the implementation of the BSE/ruminant feed ban rule in 1997, Dallas District and its State partners have inspected every known or registered feed manufacturer located in the states of Texas, Oklahoma and Arkansas. Further, every rendering operation and feed manufacturer actually processing with prohibited materials has been inspected annually. The compliance rate of the industry has been excellent.

Results:

In total FDA, along with TFFCS, conducted 33 inspections, investigations and interviews of the producer, retail feed establishments, feed manufacturers, corporate headquarters, slaughter facilities, renderers and a protein source broker. The FDA Dallas District follow-up to this incident resulted in the coordination of efforts of multiple Federal and State agencies. This report is the physical output of many hours of research, planning and coordination. All of the inspections conducted confirmed the feed manufacturers and rendering operations to be in compliance with the current BSE/ruminant feed ban rule.

Dallas District conducts annual inspections of all feed mills and rendering facilities who handle, use or produce PM for feed use. Inspections performed since the initiation of the BSE/ruminant feed ban rules in 1997 have confirmed a high degree of industry wide compliance with these important safeguards. The district also routinely coordinates and shares information regarding feed inspections with the TFFCS who are also responsible for the evaluating feed ban compliance in the state of Texas.

Food and Drug Administration
August 30, 2005
Minor edit September 8, 2005

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

ALSO, in TEXAS, cattle on feed for decades, fda says 5.5 grams ruminant protein, if tainted with TSE, is not enough to kill a cow. actually, it's enough to kill 100+ cows ;-)

http://www.fda.gov/bbs/topics/NEWS/2001/NEW00752.html

ALSO, in TEXAS, home of the SSS policy, live an in color;

“Anthrax is under-reported, because many ranchers in this area automatically dispose

of carcasses and vaccinate livestock when they find dead animals that are bloated or

bloody--common signs of the disease,” said Dr. Fancher. “Anthrax is a reportable

disease, however, and it’s important to know when an outbreak occurs, so other

ranchers can be notified to vaccinate.

http://www.tahc.state.tx.us/news/pr/2005/2005Jul_Anthrax_Confirmed_in_SuttonCty.pdf

TSS

THE END

Subject: COW SENSE: THE BUSH ADMINISTRATION’S BROKEN RECORD ON MAD COW DISEASE
Date: May 2, 2006 at 6:50 pm PST

1

COW SENSE:

THE BUSH ADMINISTRATION’S BROKEN RECORD ON

MAD COW DISEASE

A WHITE PAPER OF THE

CENTER FOR SCIENCE IN THE PUBLIC INTEREST,

OMB WATCH AND CONSUMER FEDERATION OF AMERICA

The country’s third confirmed case of Bovine Spongiform Encephalopathy, better known

as “Mad Cow Disease,”1 was discovered on March 10, 2006, in a cow located on a farm

in Alabama. When discussing this latest case of mad cow disease with a concerned

public, the U.S. Department of Agriculture’s (USDA) John Clifford announced in the

same breath that the agency intends to scale back testing for the brain-wasting disorder

from 1000 to about 110 daily. The lower testing levels haven't been finalized, “but the

department’s budget proposal calls for 40,000 tests annually,” about one-tenth of the

current testing level.2

Because of the gravity of the potential problem—mad cow disease infected millions of

cattle in Britain and resulted in 160 fatal human illnesses as well3—details about the case

are particularly troubling. The veterinarian who examined the cow estimated that it was

around 10 years old—estimated, that is, because the lack of an animal identification

program of the sort already in place in Europe, Canada, and Japan means that the

government cannot know with certainty the animal’s age. Moreover, there is much more

we do not know: we cannot know with any certainty how many calves it had, or even the

farm where it was born and probably ate the feed containing the agent that causes mad

cow disease. Without this information, it becomes nearly impossible to trace animals that

may have consumed the same infected feed and to ensure that they don’t make it into the

human or animal food supply.

The country’s first confirmed case of mad cow disease was discovered on December 23,

2003. Three years later why is the public still in the dark when it comes to mad cow

disease? Why can’t we trace animals back to the source herd to discover the related cows

that may also present the same risk to the food chain? Why are there still loopholes in the

safety net that weaken our ability to prevent the spread of BSE in the nation’s cattle herd

or even to monitor the incidence of the disease? The answer is a string of broken

promises that trace back to the special influence of special interests in the Bush

administration.

1 “USDA/Alabama BSE Epidemiological Update: News Release.” United States Department of

Agriculture. .

2 Quaid, Libby. “Update 12: Government to Scale Back Mad Cow Testing.” The Associate Press on the

web March 14, 2006. .

3 “Creutzfeld-Jakob Disease in the UK: Press release.” UK Department of Health. March 8, 2005.

.

2

Surveillance and Industry Testing

Enhanced Surveillance

In response to the discovery of the first BSE-infected cow in the U.S. in December of

2003, USDA’s Animal and Plant Health Inspection Service (APHIS) instituted an

intensive animal health testing program for BSE. According to APHIS, the program was

designed as a one-time effort to provide a snapshot of the prevalence of BSE in the

domestic cattle population. The program was designed to test as many cattle from the

high-risk population as possible in a 12- to 18-month period. 4

Since 1994, APHIS has tested over 650,000 samples with two confirmed positives from

cattle that could have been born before the implementation of 1997 feed ban. But because

of a lack of paperwork and an animal identification system, we may never know the exact

age or origin of the cattle in question.

When the recent BSE case in Alabama was announced, USDA also proposed scaling

back the surveillance program to test just 40,000 animals a year. However, Secretary

Johanns has since retreated, saying the agency is not in a hurry to reduce testing.5

Private Firms

In February of 2004, Creekstone Farms Premium Beef LLC, a privately owned producer

and processor, petitioned USDA to allow them to conduct private testing for mad cow

disease. The company wanted to regain entry into the Japanese beef market after Japan

closed its borders to American beef in 2003, citing BSE concerns. Of the roughly $3.9

billion in global sales of American beef in 2003, Japan accounted for $1.4 billion.6

Creekstone Farms was willing to address this concern by complying with Japan’s request

that every carcass exported to Japan be tested for BSE. But USDA refused the license

request. It is USDA’s contention that testing every animal or animals younger than 30

months is not scientifically justified or necessary.

While testing every animal for BSE is not necessary to assure food safety, private firms

like Creekstone should be able to voluntarily test for BSE, especially since they were

willing to do this at its own expense. USDA should not prohibit private companies from

testing their product. The Japanese government and consumers wanted all cattle tested for

mad cow disease and Creekstone was willing to comply with this request. By prohibiting

companies from giving their customers what they want, USDA is not only is restricting

free enterprise but also preventing companies from regaining the full value of their export

market. USDA’s action is in effect a disincentive for companies who are willing to go the

extra mile to address their customers concerns. It’s been over two years since Creekstone

4 Animal and Plant Health Inspection Service.

.

5 The Associated Press. “USDA in no hurry to scale back mad cow tests.” MSNBC.com on the web March

27, 2006. .

6 “Renewed Japan Beef ban prompts U.S. probe” USA Today on the web January 20, 2006.

.

3

petitioned USDA to allow testing for BSE and U.S. companies still have not fully

regained access to Japanese markets.

Bush Administration’s Broken Promises

After the first BSE case was found in the U.S, the Bush administration made a string of

promises to ensure that the United States would not experience the kind of crisis in

consumer confidence that happened in Britain. As the policy decisions moved from the

press secretary’s lectern to the pages of the Federal Register, however, the Bush

administration began to break promise after promise. Two stand out: the failure to

implement a national animal identification and tracking system; and the failure to

produce a strong feed rule to prevent the nation’s cattle herd from consuming materials

that pose the risk of transmitting BSE.

Failure to Follow Through on Animal ID

On December 30, 2003, just seven days after the first mad cow was discovered in the

United States, Secretary Ann Veneman announced that the U.S. would expedite the

adoption of a “verifiable nationwide animal identification system to help enhance the

speed and accuracy of our response to disease outbreaks across many different animal

species.”7 This important announcement was followed by multi-million dollar

investments, including $18.8 million in 2004, and Congressional appropriations of $33

million in both 2005 and 2006.8 USDA, in a 2004 statement of Undersecretary Bill

Hawkes, said that the Animal Health Protection Act gave the agency “authority to

address the animal ID system in a mandatory fashion if we so choose.”

Animal identification programs are already used in many parts of the world, including

Europe, Canada, Japan and New Zealand, to track animals and safeguard animal health.

Such systems are implemented to protect against the spread of animal diseases, some of

which also affect human health. Foot and mouth disease and bovine tuberculosis

outbreaks have historically been kept in check by controlling the movement of livestock.

When it comes to BSE, cattle identification provides critical information that helps to

identify animals from the same farm that years before may have eaten infected feed. (See

Table I.)

USDA began the implementation of the National Animal Identification System (NAIS)

on a voluntary basis in 2004. The long-term goal of the NAIS was to provide animal

health officials with the capability to identify all livestock and premises that have had

direct contact with a disease of concern within 48 hours after discovery.

7 “Veneman Announces Additional Protection Measures To Guard Against BSE: News Release No.

0449.03.” United States Department of Agriculture. December 3, 2003. < http://www.usda.

gov/Newsroom/0449.03.html>.

8 “Veneman Announces Framework and Funding for National Animal Identification System: News Release

No. 0170.04.” United States Department of Agriculture. April 27, 2004.

Newsroom/0170.04.html>.

4

While Veneman expressed urgency, in May 2005, Secretary Michael Johanns announced

that full recording of animal movements would be delayed until 2009.9 This extended

timeline reversed the expedited implementation promised by Secretary Veneman.

In a February 2006 meeting of a cattleman’s association called R-CALF, the NAIS

coordinator Neil Hammerschmidt said that the 2009 timeline would not be met, as the

agency had “no one working on rules to implement a mandatory program.”10 In a letter

to the Center for Science in the Public Interest in March 2006, USDA “clarified”

Hammerschmidt’s remarks by saying that “broad support for the NAIS will motivate a

majority of stakeholders to voluntarily participate. . . . Such market incentives could

obviate the need for our Agency to take regulatory action to make participation

mandatory.” Thus, Hammerschmidt was right – USDA had already decided that animal

identification and tracking programs would not be mandatory.

Failure to Follow Through on Cattle Feed Standards

Although cattle are ruminants that by nature eat grasses, the agribusiness practice today is

to fatten them up quickly with grains, animal proteins and other materials not typically in

a ruminant diet. Until 1997, when the practice was banned, feed manufacturers would

feed rendered cattle proteins back to cattle. This practice increased the risk of spreading

mad cow disease, as cattle were exposed to the infectious proteins (or “prions”) when

parts from infected cattle were allowed in cattle feed. This is the likely cause of the large

outbreak of BSE in cattle in Great Britain.

The Bush Administration announced plans to strengthen the feed ban in January 2004,

when the U.S. Food and Drug Administration (FDA) announced it would ban the use of

mammalian blood, poultry litter, and plate waste as feed ingredients for cattle and other

ruminants.11 Feeding plate waste and chicken litter back to cattle can recycle bovine

proteins into cattle feed.

These actions would have strengthened the feed ban and reduced the loopholes where

cattle materials could inadvertently enter cattle feed. A panel of international experts also

supported strengthening the U.S. feed ban, and urged that all animal feed should be free

of high risk cattle parts.12

9 “USDA Unveils Multi-Year Draft Strategic Plan the National Animal Identification System,” News

Release No. 0149.05.” United States Department of Agriculture. May 5, 2005.

10 “USDA abandons plan for mandatory animal ID by 2009.” Food Chemical News February 6, 2006.

47:52.

11 “Expanded "Mad Cow" Safeguards Announced To Strengthen Existing Firewalls Against BSE

Transmission: News Release.” United States Department of Health and Human Services. January 26, 2004.

.

12 International Review Team, Report on Measures Related to Bovine Spongiform Encephalopathy (BSE) in

the United States (Feb. 2, 2004)..

5

Instead of adopting these safeguards, in July 2004, FDA delayed action by announcing

another study of feed ban issues.13 Over a year later, in October 2005, the FDA proposed

minimal new restrictions on the animal feed industry – restrictions that live up to neither

their own promises nor the recommendations of the international experts.14

Special Access for Special Interests

So, why at the same time the third case of BSE was confirmed, did USDA even suggest

reducing its surveillance testing? And how did common sense protections – like the

animal identification system and safer animal feed – get scuttled or weakened beyond

recognition?

The reason? Former industry players are embedded throughout the Bush administration

and often play key roles in the agencies that are supposed to regulate those same

industries. More importantly, any time the USDA or FDA makes a promise to protect the

public, industry can use its own special hotline straight to the White House to promote its

cause.

Going Straight to the Top

Industry interests have aggressively lobbied the White House itself to distort the entire

continuum of mad cow-related policy. Although Congress delegates authority to regulate

food safety issues directly to the agencies, the White House has granted itself authority to

review agency rulemakings with a series of executive orders.15 The White House has

asserted a role in the earliest stages of policymaking by convening agencies to coordinate

regulatory priorities and by reviewing agency rulemaking agendas.16 It demands the right

to review proposed and final significant rules before they can be published in the Federal

Register.17 The White House receives—and, in fact, welcomes—ex parte

communications from industry in the course of its reviews. In accordance with the

executive order,18 the White House maintains a log of those meetings on the website for

the Office of Management and Budget’s (OMB) Office of Information and Regulatory

Affairs (OIRA).19

These White House logs reveal that the feed and rendering industries brought their top

officials into numerous meetings both before and after BSE was found in the U.S. in

order to push back on BSE policy. The logs show six meetings regarding FDA’s

13 “USDA and HHS Strengthen Safeguards Against Bovine Spongiform Encephalopathy: Press Release.

United States Department of Health and Human Services. July 9, 2004.

14 Substances Prohibited from Use in Animal Food or Feed, 70 Fed. Reg. 58569 (October 6, 2005)..

15 See Exec. Order No. 12,866, 58 Fed. Reg. 51735 (Sept. 30, 1993).

16 See id. § 4.

17 See id. § 6.

18 See id. § 6(b)(4).

19 See Office of Info. & Reg. Affs., OMB, Meetings and Outside Communication.

whitehouse.gov/omb/oira/>.

6

consideration of the feed ban and three more regarding USDA policies on specified risk

materials and downer cattle, featuring a Who’s Who of the rendering and related

industries. (See Table II.)

The rendering industry in particular has much at stake, because that sector takes cow

parts — not just those that are left over after material for beef products are removed, but

also any useable parts from cattle excluded from the food chain, including downer cows

— to produce protein feeds, tallow, meat and bone meal, and a wide array of other

products. Many such products are used in animal feeds that can be fed to hogs and

poultry, and thus can be indirectly fed back to cows because of the loophole in the FDA

feed ban rules.

In fact, some of the companies that sent executives to meet with the White House had

direct experience with mad cow disease. For example, Baker Commodities, Inc., which

sent executive vice president Ray Kelly to speak with the White House on both the FDA

feed ban and USDA policy on downer cattle and dead stock, owns two of the rendering

plants that received portions of the 6-year-old Holstein that tested positive as the

country’s first confirmed case of mad cow. Likewise, another company represented in

White House meetings, Valley Proteins, generates products—which president Gerald

Smith cannot “guarantee . . . are free of cattle products”—that are “used to make feed for

East Coast poultry and turkey farmers.”20 The renderers’ industry group National

Renderers Association ensured that its sector was well represented in White House

meetings, but one representative in particular — Don Franco, president of the Animal

Protein Producers Industry and vice president of scientific services for the National

Renderers Association, stands out from the rest because he also has a role in influencing

policy at the USDA directly. Franco was appointed in 2002 to serve a two-year term on

the USDA National Foreign Animal and Poultry Disease Advisory Committee, which is

described approvingly by the rendering industry magazine as providing “valuable

information on methods, techniques, and policies directed at preventing the introduction

of foreign diseases without imposing impractical restrictions.”21

Not surprisingly, with all the industry pressure documented publicly in the meeting logs

(and possibly complemented by yet more meetings not logged because they were held

before any policy was officially under OMB review), the White House ordered changes

in the rules that were ultimately published in the Federal Register.

Foxes in the Henhouse

It is currently unknown whether the National Cattlemen’s Beef Association (NCBA) held

any meetings with the White House, because OIRA logs only meetings about regulations

being reviewed under the executive order and USDA has made it clear that no one in the

agency was attempting to draft a rule on animal identification. Of course, NCBA did not

20 Gay, Lance. “Rendering Scrutinized Because of Mad Cow” Cincinnati (Ky.) Post Oct. 1, 2004, : at A17,

available on Westlaw at 2004 WLNR 1340543.

21 “Franco Named to Committee.” Render Magazine, Feb. 2002.

.

7

need to petition the White House to influence the agency’s priorities, because NCBA’s

interests are already deeply embedded in the USDA itself.

The USDA has a number of former executives from NCBA and other allied industry

concerns at both high levels and important staff positions:

Dale Moore, Chief of Staff at USDA since 2001, was formerly the Director of

Legislative Affairs for the National Cattlemen’s Beef Association from 1997 until his

appointment in 2001. Before that, he worked on the industry dominated House

Agriculture Committee in various positions.

Alisa Harrison served as Press Secretary and Deputy Director of Communications under

both Secretaries Veneman and Johanns. She came over to USDA directly from the

National Cattlemen’s Beef Association, where she was Executive Director of Public

Relations. Who better to handle the publicity following the first U.S. case of mad cow

disease. Clearly USDA was planning their public relations strategy long before their

public health response. Alisa Harrison is no longer at USDA.

Charles Lambert, Under Secretary for Marketing and Regulatory Programs, served 15

years in various positions at the National Cattlemen’s Beef Association in Denver and

Washington. Up to 1979, he also ran a cow-calf operation in West-Central Kansas.

Floyd D. Gaibler, Deputy Under Secretary for Farm & Foreign Ag. Services, was most

recently a consultant at Lesher & Russel, Inc., an agricultural consulting firm whose

clients include Altria, Monsanto, and the Meat Promotion Coalition, a group of

agribusiness companied that includes the National Meat Association, the American

Meat Institute, and the National Cattlemen’s Beef Association.

8

Conclusion

“Cronyism” is more than just a rhetorical bludgeon: it is a very real problem in the Bush

administration, with very serious consequences for the American public. The Bush

administration has a consistent history of putting the cattlemen’s and other special

interests above the public interest, in a “special interest takeover” of government.22 It is a

recurring problem that weakens public protections in all areas, from mine safety to the

environment. As the background of mad cow policy reveals, it is a problem that reaches

even the very food we eat.

Both to improve domestic BSE protections and to increase the Bush Administration’s

chances of getting U.S. beef into global markets, it should reverse course and institute

real reforms on mad cow disease:

• Close the loopholes in the feed ban. FDA needs to further reduce the risk of

BSE from infected animals that are not caught by its limited surveillance program

from being recycled into the cattle feed supply. Eliminating the use of bovine

blood products, chicken litter, and plate waste from animal feed is the first step.

Eliminating the use of high-risk cattle parts in all animal feed would be the most

protective. Without an animal identification and tracking system to find exposed

cattle, the risk that some of these cattle parts are getting into the food and feed

supplies is certainly elevated.

• Implement the mandatory animal ID system. The USDA should implement

the animal tracking system that is already thoroughly planned, has a multi-million

dollar investment of taxpayer funds, and has many key pieces in place. Canada

implemented its mandatory program within a single year. The United States has

been working on the animal ID plan since before 2003. It has the legal authority

but lacks the political will to implement a world class system, like those relied on

in many other countries. With nearly $100 million invested in the program,

USDA should make good on its promises and implement a mandatory system by

January 2007.

• Until USDA has a program in place to identify cattle that were exposed to

infected feed, USDA should (1) test all cattle of any age showing signs of central

nervous system disease; (2) continue a high-intensity testing system of all cattle

30 months or older; and (3) test a random sampling of healthy animals 20 to 30

months old. Companies that want to test their own cattle should not be prohibited

from doing so by the government.

• Cut off the special interest hotline to the White House. When it comes to mad

cow disease, the White House Office of Management and Budget has seen a

22 See generally Center for Amer. Prog. & OMB Watch. “Special Interest Takeover: The Bush

Administration and the Dismantling of Public Safeguards (2004).”

.

9

parade of special interest lobbyists who have had an impact on reducing the level

of protection that the Bush Administration promised, but never delivered.

Centralizing regulatory review in the White House gives industry a one-stop shop:

what they can’t achieve by having industry insiders staffing the agencies, they can

get by sitting down with the Bush administration’s top officials. Congress should

shut down this special access for special interests.

With these simple remedies, the Bush administration and Congress would ensure that the

next time someone claims to be sickened by the culture of corruption in the Bush

administration and its cozy ties with industry, the claim is merely rhetorical — not literal.

10

Table I

Does Animal ID Work?

Comparing Canada’s mandatory tracking system

with the U.S. system

CANADA Confirmed BSE Cases1

Proportion of Birth Cohort

Identified

Percentage

May 20, 2003; Alberta, Canada

undetermined

undetermined

Dec 23, 2003; Washington State*

Birth herd in Alberta, Canada

55 out of 57

96%

Jan 2, 2005; Alberta, Canada

135 out of 135

100%

Jan 11, 2005; Alberta, Canada

349 out of 349

100%

Jan 22, 2006; Alberta, Canada

156 out of 156

100%

U.S. Confirmed BSE Cases

Proportion of Birth Cohort

Identified

Percentage

Dec 23, 2003; Washington State1*

Herd imported to United States in 2001

Animals imported & also from birth herd

29 out of 81

14 out of 25

36%

56%

June 24, 2005; Texas2

146 out of 200

73%

March 15, 2006; Alabama3

Pending

Pending

*The U.S. cow originated from Alberta, Canada.

1 CFIA, BSE in North America, Completed Investigations, available at:

2 USDA APHIS, Texas BSE Investigation, Final Epidemiology Report, August 2005, available at:

http://www.aphis.usda.gov/lpa/issues/bse/epi-updates/bse_final_epidemiology_report.pdf

3 USDA/Alabama BSE Epidemiological Update, aavailable at:

11

Table II

Meatings

An Overview of White House Meetings

With Special Interests on Mad Cow Policy

Office of Management and Budget Meetings on USDA Policies

Regarding Specified Risk Materials and Downer Cattle

2005 July 5 Australian Embassy

July 12 North American Casing Association

August 11 North American Casings Association – oral

contact

October 18 Darling International

Baker Commodities

National By-Products

National Renderers Association

Office of Management and Budget Meetings on FDA Policies Regarding

Ruminant Feed

2002 August 12 American Feed Industry Association

August 21 Darling International

Baker Commodities

National By-Products

September 26 National Renderers Association

2005 August 23 Darling International

Valley Proteins

Kaluzny Bros.

Griffin Industries

Anamax Group

National By-Products

National Renderers Association

August 24 American Feed Industry Association

August 26 Pet Food Industry

Canadian Cattlemen’s Association

American Meat Institute

National Grain & Feed Association

Canadian Meat Council

http://www.ombwatch.org/regs/2006/cowsense.pdf

913. SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED

Agency:

Department of Health and Human Services (HHS)/Food and Drug Administration (FDA)

Priority:

Other Significant

Legal Authority:

21 USC 321; 21 USC 342; 21 USC 343; 21 USC 349; 21 USC 371

CFR Citation: (To search for a specific CFR, visit the Code of Federal Regulations.)

21 CFR 589.2001

Legal Deadline:

None

Abstract:

On October 6, 2005, the Food and Drug Administration (FDA) proposed to amend its regulations to prohibit the use of certain cattle origin materials in the food or feed of all animals to help strengthen existing safeguards to prevent the spread of bovine spongiform encephalopathy (BSE) in U.S. cattle. The discovery of a BSE-positive dairy cow in December 2003 has caused FDA to review its policies for prevention of BSE which resulted in this rulemaking.

Timetable: Action Date FR Cite
ANPRM 07/14/04 69 FR 42288
ANPRM Comment Period End 08/13/04
NPRM 10/06/05 70 FR 58569
NPRM Comment Period End 12/20/05
Final Action 07/00/06

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses

Government Levels Affected:

None

Agency Contact:

Burt Pritchett, Biologist, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, HFV-222, 7519 Standish Place, MPN-4, Rockville, MD 20855

Phone: 240 453-6860

Fax: 240 453-6882

Email: burt.pritchett@fda.hhs.gov

RIN:

0910-AF46

http://ciir.cs.umass.edu/cgi-bin/ua/web_fetch_doc?dataset=ua&db=agendaSpring2006&query=and&doc_id=913

914. USE OF MATERIALS DERIVED FROM CATTLE IN HUMAN FOOD AND COSMETICS

Agency:

Department of Health and Human Services (HHS)/Food and Drug Administration (FDA)

Priority:

Other Significant

Legal Authority:

21 USC 342; 21 USC 361; 21 USC 371

CFR Citation: (To search for a specific CFR, visit the Code of Federal Regulations.)

21 CFR 189.5; 21 CFR 700.27

Legal Deadline:

None

Abstract:

On July 14, 2004, FDA issued an interim final rule (IFR), effective immediately, to prohibit the use of certain cattle material, to address the potential risk of bovine spongiform encephalopathy (BSE), in human food, including dietary supplements, and cosmetics. Prohibited cattle materials under the IFR include specified risk materials, small intestine of all cattle, material from nonambulatory disabled cattle, material from cattle not inspected and passed for human consumption, and mechanically separated (MS) (Beef). Specified risk materials are the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months and older; and the tonsils and distal ileum of the small intestine of all cattle. Prohibited cattle materials do not include tallow that contains no more than 0.15 percent hexane-insoluble impurities and tallow derivatives. This action minimizes human exposure to materials that scientific studies have demonstrated are highly likely to contain the BSE agent in cattle infected with the disease. Scientists believe that the human disease variant Creutzfeldt-Jakob disease (vCJD) is likely caused by the consumption of products contaminated with the agent that causes BSE. After reviewing comments received to the interim final rule, FDA intends to issue a final rule.

On September 7, 2005, FDA amended the IFR to permit the use of small intestine in human food and cosmetics if it is effectively removed from the distal ileum. The amendment also clarified that milk and milk products, hides, and tallow derivatives are not prohibited for use in human food and cosmetics.

Timetable: Action Date FR Cite
Interim Final Rule 07/14/04 69 FR 42256
Interim Final Rule Comment Period End 10/12/04
Interim Final Rule (Ammendments) 09/07/05 70 FR 53063
Final Action 07/00/06

Regulatory Flexibility Analysis Required:

No

Small Entities Affected:

No

Government Levels Affected:

None

Agency Contact:

Morris E. Potter, Lead Scientist for Epidemiology, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, HFS-032, 60 Eighth St., NE, Atlanta, GA 30309

Phone: 404 253-1225

Fax: 404-253-1218

Email: morris.potter@fda.hhs.gov

RIN:

0910-AF47

http://ciir.cs.umass.edu/cgi-bin/ua/web_fetch_doc?dataset=ua&db=agendaSpring2006&query=and&doc_id=914

915. RECORDKEEPING REQUIREMENTS FOR HUMAN FOOD AND COSMETICS MANUFACTURED FROM, PROCESSED WITH, OR OTHERWISE CONTAINING MATERIAL FROM CATTLE

Agency:

Department of Health and Human Services (HHS)/Food and Drug Administration (FDA)

Priority:

Other Significant

Legal Authority:

21 USC 342; 21 USC 361; 21 USC 371; 21 USC 381

CFR Citation: (To search for a specific CFR, visit the Code of Federal Regulations.)

21 CFR 189.5; 21 CFR 700.27

Legal Deadline:

None

Abstract:

On July 14, 2004, FDA proposed to require that manufacturers and processors of human food and cosmetics that are manufactured from, processed with, or otherwise contain, material from cattle must establish and maintain records sufficient to demonstrate the food or cosmetic is not manufactured from, processed with, or does not otherwise contain, prohibited cattle materials. This is a companion rulemaking to FDA's interim final rule entitled "Use of Materials Derived From Cattle in Human Food and Cosmetics." FDA intends to finalize this proposal after reviewing any comments received.

Timetable: Action Date FR Cite
NPRM 07/14/04 69 FR 42275
NPRM Comment Period End 08/13/04
Final Action 09/00/06

Regulatory Flexibility Analysis Required:

No

Small Entities Affected:

Businesses

Government Levels Affected:

None

Agency Contact:

Rebecca Buckner, Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, HFS-366, College Park, MD 20740

Phone: 301 436-1486

Fax: 301 436-2632

Email: rebecca.buckner@fda.hhs.gov

RIN:

0910-AF48

http://ciir.cs.umass.edu/cgi-bin/ua/web_fetch_doc?dataset=ua&db=agendaSpring2006&query=and&doc_id=915

http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf

https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument

https://web01.aphis.usda.gov/BSEcom.nsf/0/b78ba677e2b0c12185256dd300649f9d?OpenDocument&AutoFramed

http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt

http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html

http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be09.html

http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf

http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm

TSS

Subject: USDA STATEMENT Regarding the Conclusion of the Epidemiological Investigation Into BSE POSITIVE IN ALABAMA
Date: May 3, 2006 at 7:13 am PST

May 2, 2006 - Sparks Announces Conclusion of Epi Investigation of BSE Positive Cow
MONTGOMERY – Commissioner Ron Sparks has announced that the Alabama Department of Agriculture and Industries, the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS), and the U.S. Department of Health and Human Services’ Food and Drug Administration (FDA) have completed their epidemiological investigation regarding a cow that tested positive for bovine spongiform encephalopathy (BSE) in Alabama in March.

May 2, 2006 - Sparks Announces Conclusion of Epi Investigation of BSE Positive Cow
May 2, 2006 - Sparks Announces Conclusion of Epi Investigation of BSE Positive Cow

The results indicate that the positive animal, called the index animal, was a red crossbreed. This animal was non-ambulatory on the farm, known as the index farm, and examined by a local, private veterinarian. The veterinarian returned to the farm the following day, euthanized the animal and collected a sample, which was submitted for BSE testing. The animal was buried on the farm at that time and did not enter the animal or human food chain, in accordance with APHIS protocols.

Alabama officials and APHIS excavated the index animal’s carcass and through dentition, an examination of its teeth, determined the animal to be more than 10 years old. It was born prior to the implementation of FDA’s 1997 feed ban that minimizes the risk that a cow might consume feed contaminated with the agent thought to cause BSE.

Alabama state officials and APHIS investigated 36 farms and 5 auction houses and conducted DNA testing on herds that may have included relatives of the index animal. State investigators and APHIS were unable to find any related animals except for the two most recent calves of the index animal. The most recent calf was located at the same farm as the index animal and the second calf died the year before. No other animals of interest were located. The living calf of the BSE-positive animal is currently being held at APHIS’ National Veterinary Services Laboratory in Ames, Iowa, for observation.

The state and federal joint investigation did not reveal the BSE-positive animal’s herd of origin. However, this was not entirely unexpected due to the age of the animal, along with its lack of identifying brands, tattoos and tags. Experience worldwide has shown that it is highly unusual to find BSE in more than one animal in a herd or in an affected animal’s offspring.

To ensure that adequate feed controls were in place in the feed facilities in the immediate geographic area of the index farm, FDA conducted a feed investigation into local feed mills that may have supplied feed to the index animal after the 1997 feed ban. This investigation found that all local feed mills that handle prohibited materials have been and continue to be in compliance with the FDA’s feed ban.

As part of APHIS’ BSE enhanced surveillance program, more than 700,000 samples have been tested since June 2004. To date, only two of these highest risk animals has tested positive for the disease as part of the surveillance program, for a total of three cases of BSE in the United States. While APHIS’ epidemiological investigation did not locate additional animals of interest, it is important to remember that human and animal health in the United States is protected by a system of interlocking safeguards, which ensure the safety of U.S. beef. The most important of these safeguards is the ban on specified risk materials from the food supply and the FDA's 1997 feed ban.

NOTE: For more information on USDA’s epidemiological investigation and a copy of the report, please visit the APHIS website at www.aphis.usda.gov/newsroom/hot_issues/bse.shtml.

Federal Contacts:
Jim Rogers, USDA 202-690-4755
Rae Jones, FDA 301-827-6242

http://www.agi.state.al.us/press_releases/may-2-2006---sparks-announces-conclusion-of-epi-investigation-of-bse-positive-cow?pn=2

Jim Rogers, USDA 202-690-4755
Rae Jones, FDA 301-827- 6242
Christy Rhodes, Alabama 334-240-7103

Statement by USDA Chief Veterinary Officer John Clifford Regarding the Conclusion of the Epidemiological Investigation Into a Bovine Spongiform Encephalopathy (BSE)-Positive Cow Found in Alabama
May 2, 2006

“The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) and the U.S. Department of Health and Human Services’ Food and Drug Administration (FDA) have completed their investigations regarding a cow that tested positive for bovine spongiform encephalopathy (BSE) in Alabama in March. Both agencies conducted their investigations in collaboration with the Alabama Department of Agriculture and Industries.

“Our results indicate that the positive animal, called the index animal, was a red crossbreed. This animal was non-ambulatory on the farm, known as the index farm, and examined by a local, private veterinarian. The veterinarian returned to the farm the following day, euthanized the animal and collected a sample, which was submitted for BSE testing. The animal was buried on the farm at that time and did not enter the animal or human food chain, in accordance with APHIS protocols.

“APHIS and Alabama officials excavated the index animal’s carcass and through dentition, an examination of its teeth, determined the animal to be more than 10 years old. It was born prior to the implementation of FDA’s 1997 feed ban that minimizes the risk that a cow might consume feed contaminated with the agent thought to cause BSE.

“APHIS and Alabama State officials investigated 36 farms and 5 auction houses and conducted DNA testing on herds that may have included relatives of the index animal. APHIS and State investigators were unable to find any related animals except for the two most recent calves of the index animal. The most recent calf was located at the same farm as the index animal and the second calf died the year before. No other animals of interest were located. The living calf of the BSE-positive animal is currently being held at APHIS’ National Veterinary Services Laboratory in Ames, Iowa, for observation.

“APHIS’ investigation did not reveal the BSE-positive animal’s herd of origin. However, this was not entirely unexpected due to the age of the animal, along with its lack of identifying brands, tattoos and tags. Experience worldwide has shown that it is highly unusual to find BSE in more than one animal in a herd or in an affected animal’s offspring.

“To ensure that adequate feed controls were in place in the feed facilities in the immediate geographic area of the index farm, FDA conducted a feed investigation into local feed mills that may have supplied feed to the index animal after the 1997 feed ban. This investigation found that all local feed mills that handle prohibited materials have been and continue to be in compliance with the FDA’s feed ban.

“As part of APHIS’ BSE enhanced surveillance program, more than 700,000 samples have been tested since June 2004. To date, only two of these highest risk animals has tested positive for the disease as part of the surveillance program, for a total of three cases of BSE in the United States. While APHIS’ epidemiological investigation did not locate additional animals of interest, it is important to remember that human and animal health in the United States is protected by a system of interlocking safeguards, which ensure the safety of U.S. beef. The most important of these safeguards is the ban on specified risk materials from the food supply and the FDA's 1997 feed ban. ”

#

http://www.aphis.usda.gov/newsroom/content/2006/05/alepi.shtml

Alabama BSE Investigation

Final Epidemiology Report

May 2, 2006

snip...

Summary:

Despite a thorough investigation of two farms that were known to contain the index cow,

and 35 other farms that might have supplied the index cow to the farms where the index

case was known to have resided, the investigators were unable to locate the herd of

origin. The index case did not have unique or permanent identification, plus, the size and

color of the cow being traced is very common in the Southern United States. Due to the

unremarkable appearance of solid red cows, it is not easy for owners to remember

individual animals. In the Southern United States, it is common business practice to buy

breeding age cows and keep them for several years while they produce calves. Most

calves produced are sold the year they are born, whereas breeding cows are sold when

there is a lapse in breeding, which can occur multiple times in cows’ lives. For all of

these reasons, USDA was unable to locate the herd of origin.

snip...

http://www.aphis.usda.gov/newsroom/hot_issues/bse/content/printable_version/EPI_Final.pdf

Subject: [Docket No. APHIS-2006-0047] Bovine Spongiform Encephalopathy; Availability of an Estimate of Prevalence in the United States
Date: May 3, 2006 at 7:10 am PST

[Federal Register: May 3, 2006 (Volume 71, Number 85)]
[Notices]
[Page 26019-26020]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03my06-36]

-----------------------------------------------------------------------

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2006-0047]

Bovine Spongiform Encephalopathy; Availability of an Estimate of
Prevalence in the United States

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: We are advising the public that an analysis of the prevalence
of bovine spongiform encephalopathy (BSE) in the United States has been
prepared by the Animal and Plant Health Inspection Service. We are
making the analysis of BSE prevalence in this country available to the
public.

ADDRESSES: Copies of the analysis are available for review on the
Internet (see SUPPLEMENTARY INFORMATION below) and 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.

FOR FURTHER INFORMATION CONTACT: Dr. Brian McCluskey, National
Surveillance Coordinator, National Surveillance Unit, Center for Animal
Health Surveillance, VS, APHIS, USDA, 2150 Centre Avenue, Fort Collins,
CO 80526-8177; 970-494-7589.

SUPPLEMENTARY INFORMATION: Bovine spongiform encephalopathy (BSE) is a
progressive and fatal neurological disorder of cattle that results from
an unconventional transmissible agent. BSE belongs to the family of
diseases known as transmissible spongiform encephalopathies (TSEs).
Since 1990, the United States has conducted surveillance for BSE in
this country with increasing intensity, including an enhanced
surveillance effort implemented following the diagnosis of BSE in a cow
of Canadian origin in Washington State in December 2003.

[[Page 26020]]

The Animal and Plant Health Inspection Service (APHIS) has
conducted an analysis of the BSE surveillance data collected in the
United States. Based on this analysis, APHIS has arrived at an estimate
of BSE prevalence in this country. This information will help to guide
and support any future requests for consideration of the overall BSE
status of the United States.
We are making our analysis of BSE prevalence in the United States
available to the public. This report is considered a draft and will
undergo peer review.
The analysis may be viewed on the APHIS Web site at http://www.aphis.usda.gov/newsroom/hot_issues/bse/bse_in_usa.shtml.
Click

on the document titled ``An Estimate of the Prevalence of BSE in the
United States.'' The analysis may be also viewed on the Regulations.gov
Web site. Go to http://www.regulations.gov, click on the ``Advanced

Search'' tab and select ``Docket Search.'' In the Docket ID field,
enter APHIS-2006-0047, click on ``Submit,'' then click on the Docket ID
link in the search results page. The analysis will appear in the
resulting list of documents.
You may request paper copies of the analysis by calling or writing
to the person listed under FOR FURTHER INFORMATION CONTACT. Please
refer to the title of the analysis (``An Estimate of the Prevalence of
BSE in the United States'') when requesting copies. The analysis is
also available for review in our reading room (information on the
location and hours of the reading room is provided under the heading
ADDRESSES at the beginning of this notice).

Done in Washington, DC, this 1st day of May 2006.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E6-6728 Filed 5-2-06; 8:45 am]

BILLING CODE 3410-34-P

http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/E6-6728.htm

http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/pdf/E6-6728.pdf

CDC DR. PAUL BROWN TSE EXPERT COMMENTS 2006The 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

CDC - Afterthoughts about Bovine Spongiform Encephalopathy and ... Afterthoughts about Bovine Spongiform Encephalopathy and Variant Creutzfeldt-Jakob Disease. Paul Brown Senior Investigator, National Institutes of Health, ...

http://www.cdc.gov/ncidod/eid/vol7no3_supp/brown.htm

PLEASE SEE FLAMING EVIDENCE THAT THE USDA ET AL COVERED UP MAD COW DISEASE IN TEXAS ;
PAGE 43; Section 2. Testing Protocols and Quality Assurance Controls snip...
FULL TEXT 130 PAGES

http://www.usda.gov/oig/webdocs/50601-10-KC.pdf

[GAO-05-101 ] Mad Cow Disease: FDA's Management of the Feed Ban Has Improved, but Oversight Weaknesses Continue to Limit Program Effectiveness Size: 104986 , Score: 1000 , TEXT , PDF , SUMMARY

http://frwebgate.access.gpo.gov/cgi-bin/useftp.cgi?IPaddress=162.140.64.88&filename=d05101.txt&directory=/diskb/wais/data/gao

[2] [GAO-05-101 ] Mad Cow Disease: FDA's Management of the Feed Ban Has Improved, but Oversight Weaknesses Continue to Limit Program Effectiveness Size: 104986 , Score: 1000 , TEXT , PDF , SUMMARY
http://frwebgate.access.gpo.gov/cgi-bin/useftp.cgi?IPaddress=162.140.64.88&filename=d05101.txt&directory=/diskb/wais/data/gao
[Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirement for the Disposition of Non-Ambulatory Disabled Cattle 03-025IFA 03-025IFA-2 Terry S. Singeltary

http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf

Subject: Substances Prohibited from Use in Animal Food or Feed, Proposed Rule, Docket No. 2002N-0273 C-534 VOL 45 (PhRMA) and Entered On February 17, 2006 Date: March 10, 2006 at 5:23 pm PST Marie A. Vodicka, PhD Assistant Vice President Biologics & Blotechnology Scientlflc & Regulatory Affairs SCIENCE & REG AFFAIRS Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, rrn . 1061 Rackville, MD 20862 Re: Substances Prohibited from Use in Animal Food or Feed, Proposed Rule, Docket No. 2002N-0273 February 14, 2006 Dear Sir or Madam : The Pharmaceutical Research and Manufacturers of America (PhRMA) is providing comment to the proposed rules issued. ......
snip...

http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000534-01-vol45.pdf

Subject: Docket No: 2002N-0273 (formerly Docket No. 02N-0273) Substances Prohibited From Use in Animal Food and Feed PAUL BROWNDate: January 20, 2006 at 9:31 am PST December 20,2005 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane Room 1061 Rockville, MD 20852 Re: Docket No: 2002N-0273 (formerly Docket No. 02N-0273) Substances Prohibited From Use in Animal Food and Feed Dear Sir or Madame: As scientists and Irecognized experts who have worked in the field of TSEs for decades, we are deeply concerned by the recent discoveries of indigenous BSE infected cattle in North America and appreciate the opportunity to submit comments to this very......... snip... Given that BSE can be transmitted to cattle via an oral route with just .OO1 gram of infected tissue, it may not take much infectivity to contaminate feed and keep the disease recycling. ........

http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000490-vol40.pdf

December 19, 2005 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane Room 1061 Rockville, MD 20852 Re: Docket No: 2002N-0273 (formerly Docket No. 02N-0273) Substances Prohibited From Use in Animal Food and Feed Dear Sir or Madame: The McDonald’s Corporation buys more beef than any other restaurant in the United States. It is essential for our customers and our company that the beef has the highest level of safety. Concerning BSE, ........... snip.......

http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273_emc-000134-02.pdf

THE SEVEN SCIENTIST REPORT ***

http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-EC244-Attach-1.pdf

http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf

Sent: Saturday, June 04, 2005 8:07 AM
Subject: BSE OIE CHAPTER 2.3.13 (The Weakening of a already terribly flawwed BSE/TSE surveillance system)

http://p079.ezboard.com/fwolftracksproductionsfrm2.showMessage?topicID=470.topic

Audit Report Animal and Plant Health Inspection Service Bovine Spongiform
Encephalopathy (BSE) Surveillance Program – Phase II and Food Safety andInspection Service Controls Over BSE Sampling, Specified Risk Materials, andAdvanced Meat Recovery Products - Phase III

http://brain.hastypastry.net/forums/showthread.php?t=120372

Subject: Re: Summary of Enhanced BSE Surveillance in the United States & BSE Prevalence Estimate for U.S. April 27, 2006Date: April 28, 2006 at 10:20 am PSTRelease No. 0143.06Contact:Ed Loyd (202) 720-4623Jim Rogers (202) 690-4755

http://disc.server.com/discussion.cgi?disc=167318;article=2815;title=CJD%20WATCH

Meanwhile, back at the ranch with larry, curly, and mo at USDA ET AL ON BSE ALABAMA STYLE

http://www.prwatch.org/node/4624

http://disc2.server.com/discussion.cgi?disc=167318;article=2763;title=CJD%20WATCH

TSS

Kevin, you are so proud of your biased, slanted "news" stories paid for by your corporate and government clients who are featured in them, why not share them with the world? I hereby challenge you to make them all public by posting them online for all to see as they are produced and distributed, as we did with the VNRs we captured. Then, since you monitor for your clients exactly where this fake news aired, you shuold also post online information about which stations aired them, when and where. This is the age of the internet Kevin, and this sort of transparency would be wonderful! All the great information in your VNRs would reach an even wider audience. Let me know if you need any technical help in doing this. However, I know that you won't take up this challenge because you would be doing just what we've done, exposing how much of TV news is really just the disguised and plagiarized airings of PR videos.