SEARCH VEGSOURCE:

 

 

Follow Ups | Post Followup | Back to Discussion Board | VegSource
See spam or
inappropriate posts?
Please let us know.
  




From: TSS ()
Subject: BSE USDA MAD COW PROTOCOLS, OIG $ GAO [cover up until caught, then cover up some more] NO SPANK POLICY
Date: June 20, 2005 at 12:10 pm PST

BSE USDA MAD COW PROTOCOLS, OIG $ GAO [cover up until caught, then cover up some more] NO SPANK POLICY


THIS _NO SPANK_ POLICY OF THE OIG AND GAO MUST CEASE NOW BEFORE MORE
HUMAN AND ANIMALS ARE EXPOSED TO THIS AGENT...TSS


Release No. 0217.05
Contact:
Office of Communication (202) 720-4623

Printable version
Statement by Agriculture Secretary Mike Johanns Regarding the Sample Sent
to Weybridge, England for Further Testing June 16, 2005
"We find ourselves in a situation where we have two internationally accepted
tests that have produced conflicting results. I believe in this situation we
have an obligation to be thorough. We've consulted with our top scientists
at USDA and with internationally recognized experts to determine our best
course in this unique case. We have agreed upon a protocol that includes
additional testing both here at USDA and at an international reference
laboratory in Weybridge, England. When we have all of the final results we
will share them very publicly.

"We know there is absolutely no risk to animal or human health related to
this case. Our safeguards worked exactly as they were designed to work.
Because they worked, we now have the opportunity to learn more about this
sample, knowing it could advance the science behind our testing efforts."


Last Modified: 06/16/2005


http://www.usda.gov/wps/portal/usdahome?contentidonly=true&contentid=2005/06/0217.xml

B. Investigation of Handling of CNS-Suspect Cow in San Angelo, Texas

Overview

On May 4, 2004, the FSIS Acting Regional Director in Dallas, Texas reported that a cow

identified as having Central Nervous System (CNS) symptoms by an FSIS veterinarian at

Lone Star Beef Processors (Lone Star Beef), a beef processing facility in San Angelo,

Texas was not tested for BSE after it had been slaughtered. The initial decision by the

FSIS Veterinary Medical Officer (VMO) on-site at Lone Star Beef to have the cow tested

for BSE was overturned by a senior APHIS official and the cow’s carcass was sent to a

rendering plant. FSIS regulations at the time of the incident required VMOs to contact

the APHIS Assistant Area Veterinarian in Charge (AAVIC) to allow APHIS to collect a

BSE surveillance sample from suspect cattle.

OIG initiated an investigation to determine if the AAVIC in Austin, Texas, provided a

false statement to USDA FSIS investigators during their inquiry of his decision not to test

the animal at Lone Star Beef. To conduct our investigation, OIG reviewed previously

obtained statements, various documents and USDA regulations, and interviewed APHIS,

FSIS, beef processing facility, and rendering company personnel.

Summary of OIG Findings

The OIG investigation found no substantive evidence that the USDA official(s)

responsible for the decision not to take brain tissue samples from the cow for BSE

testing, or any other USDA personnel, provided false information or engaged in

intentional misconduct. We determined that a misjudgment was made by at least one

USDA veterinary official in the handling of the suspect cow. Sworn statements provided

by the two responsible USDA veterinary officials involved differ as to whether both

concurred in this decision.

The suspect cow’s carcass was sent to a rendering plant in San Angelo on April 27, 2004

for processing as inedible by-product. APHIS then utilized its "Indemnity Plan"

10

procedures to purchase the by-products as a preventative safety measure, and disposed of

it at a local landfill in accordance with applicable environmental standards.

Evidence shows that at the time of this incident, communication problems occurred

between the APHIS and FSIS employees involved. Taken together, the statements of

both APHIS and FSIS personnel and other evidence indicate inconsistencies in their

understanding of procedures for BSE tissue sampling of CNS suspect cattle in certain

circumstances, and the handling of the carcass pending test results. It is apparent from

the sworn statements provided to OIG that APHIS and FSIS personnel and Lone Star

Beef officials could not resolve how best to proceed, and that confusion existed about

how to properly handle the CNS-suspect carcass.

On May 5, 2004, FSIS and APHIS Veterinary Services announced a new joint policy

regarding BSE sampling of condemned cattle at slaughter plants. The policy establishes

protocols for the agencies’ responsibilities to obtain samples from condemned cattle

exhibiting signs of CNS disorders, regardless of age. ...

snip...

http://www.usda.gov/oig/webdocs/Testimony7-2004.pdf


USDA Office of Inspector General Statement on Audit Work Related to the BSE Test

Result Announced on June 10, 2005

In August 2004, the Department of Agriculture’s (USDA) Office of Inspector General

(OIG) issued an audit report on USDA’s BSE Surveillance Program—Phase I. (See

OIG’s website at: http://www.usda.gov/oig/webdocs/50601-9-final.pdf.) OIG made a

number of recommendations to improve the Department’s BSE Surveillance Plan in the

Phase I audit report. Based on our audit findings, we recommended that USDA fully

disclose the assumptions behind its sampling plan, clarify the limitations, and ensure that

all high-risk animals are sampled and tested in accordance with USDA policy and the

2004 Surveillance Plan. We also recommended that USDA expedite development of a

new system to track and report accomplishments, and implement performance measures

and a continuous risk assessment.

Currently, OIG has two audits in progress pertaining to BSE. In our BSE Surveillance

Program—Phase II audit, OIG is monitoring the Department’s implementation of its

BSE Expanded Surveillance Program, involving both APHIS and FSIS. This audit will

evaluate the following: the effectiveness of USDA’s expanded BSE Surveillance

program; the performance of BSE laboratories in meeting their objectives and complying

with program policies and procedures for conducting tests on submitted BSE samples and

reporting test results to APHIS and stakeholders; and the corrective actions taken by

USDA in response to recommendations in the BSE Surveillance Program—Phase I audit

report cited above.

In our Phase III audit, we are evaluating whether the USDA enforcement of the ban on

specified risk materials (SRMs) in meat products and controls to prevent central nervous

system (CNS) tissue in advanced meat recovery (AMR) product have been effectively

implemented. The review also covers FSIS ante mortem condemnation procedures

and procedures for obtaining brain tissue samples from condemned cattle for BSE testing.

In the course of reviewing voluminous records and information gathered during the BSE

Surveillance Program—Phase II audit, OIG auditors noted an unusual pattern of

conflicting test results on one sample and initiated additional testing of that sample. As

announced by USDA on June 10, the sample subsequently rendered a positive result

under the OIE (World Organization for Animal Health) recognized SAF immunoblot test.

OIG’s fieldwork on these audits is ongoing. Once the audits are completed, OIG will

report on the specific BSE Enhanced Surveillance Program issues and procedures we

examined, our corresponding findings and recommendations, and USDA’s response

thereto. We anticipate completing and publicly releasing the reports late this summer.

http://www.usda.gov/oig/webdocs/BSEStatement050615.pdf

January 2002

MAD COW DISEASE

Improvements in the

Animal Feed Ban and

Other Regulatory

Areas Would

Strengthen U.S.

Prevention Efforts

snip...

Results in Brief

While BSE has not been found in the United States, federal actions do not

sufficiently ensure that all BSE-infected animals or products are kept out

or that if BSE were found, it would be detected promptly and not spread to

other cattle through animal feed or enter the human food supply. With

regard to imports, the United States had imported about 125 million

pounds of beef (0.35 percent of total imported) and about 1,000 cattle

(0.003 percent of total imported) from countries that later discovered

BSE—during the period when BSE would have been incubating. In

addition, weaknesses in USDA’s and FDA’s import controls, such as

inspection capacity that has not kept pace with the growth in imports, may

allow BSE-infected products to enter the country. With regard to animal

testing to detect BSE, although USDA has steadily increased the number of

animals it tests, it does not include many animals that die on farms.

Experts consider these animals a high-risk population. Concerning the

feed ban, FDA has not acted promptly to compel firms to keep prohibited

proteins out of cattle feed and to label animal feed that cannot be fed to

cattle. We identified some noncompliant firms that had not been

reinspected for 2 or more years and instances when no enforcement action

had occurred even though the firms had been found noncompliant on

multiple inspections. Moreover, FDA’s data on inspections are severely

flawed and, as a result, FDA does not know the full extent of industry

compliance. FDA acknowledges that it has not yet identified and inspected

all firms subject to the ban. In terms of the public health risk, consumers

do not always know when foods and other products they use may contain

central nervous system tissue, which, according to scientific experts,

could pose a health risk if taken from diseased animals.

The economic impacts of a BSE outbreak in the United States could be

severe, according to federal economists. However, scientific experts

believe the health risks are uncertain. In terms of the economic impacts, if

BSE were discovered in U.S. cattle, beef exports and domestic beef

consumption would drop. The severity and duration of the economic

impact would depend largely on the number of animals affected, the U.S.

response, and the public’s reaction. We could not extrapolate the potential

impact on the U.S. economy by looking at the experiences of countries

Page 3 GAO-02-183 Mad Cow Disease

with BSE because perceptions about food safety risks vary from country

to country, and the economic impacts of BSE on one country might not be

applicable to another. Nonetheless, if BSE were found here, the economic

impact on the $56 billion beef industry could be devastating. Many

consumers might refuse to buy domestic beef; beef exports could decline

dramatically and sales in related industries—such as hamburger chains

and soup and frozen dinner manufacturers—could be similarly affected.

Concerning the health risks, if BSE-infected cattle were to enter the food

supply, some people might develop vCJD. However, experts disagree

about the number of people who would be affected. While many believe

that vCJD is very difficult to contract, so that relatively few people would

develop it, some experts believe that, because of the long incubation

period, no one can predict whether few or many might contract vCJD.

The United States acted as many as 5 years earlier than other countries to

impose controls over imports of animals and animal feed ingredients from

countries that had experienced BSE. Similarly, U.S. surveillance efforts to

test cattle brains for BSE met internationally recommended testing targets

earlier than other countries. However, the United States has a more

permissive feed ban than other countries—one that allows cattle feed to

contain proteins from horses and pigs. FDA is reviewing whether these

ingredients should continue to be allowed in cattle feed. Finally, as in most

countries that are BSE-free, including the United States, cattle brains and

other central nervous system tissue can be sold as human food.

This report makes recommendations to USDA and FDA to, among other

things, strengthen enforcement of the feed ban, develop a coordinated

strategy to identify resources needed to increase inspections of imported

goods, and alert consumers when products may contain central nervous

system tissue. In commenting on a draft of this report, FDA and Customs

concurred with our recommendations. USDA largely concurred but said

that labeling and warning statements should be reserved for known

hazards. ...

snip...full text 63 pages;

http://www.gao.gov/new.items/d02183.pdf

For Release on Delivery

Expected at 3:00 p.m. EST

Tuesday, March 30, 2004

FEDERAL FOOD SAFETY

AND SECURITY SYSTEM

Fundamental Restructuring

Is Needed to Address

Fragmentation and Overlap

Statement of Lawrence J. Dyckman, Director

Natural Resources and Environment

snip...

Page 12 GAO-04-588T

Multiple agencies must respond when serious food safety

challenges emerge. Inconsistent food safety authorities result in the need

for multiple agencies to respond to emerging food safety challenges. This

was illustrated recently with regard to ensuring that animal feed is free of

diseases, such as bovine spongiform encephalopathy (BSE), or mad cow

disease. A fatal human variant of the disease is linked to eating beef from

cattle infected with BSE. As we reported in 2002, four federal agencies are

responsible for overseeing the many imported and domestic products that

6USDA officials report that rulemaking for shell eggs will be separate from rulemaking for

egg products because shell egg packing facilities lack the capacity to respond to a Hazard

Analysis and Critical Control Point (HACCP) rule at present. USDA officials explain that

they will likely propose HACCP and sanitation performance standard regulations for egg

product plants, while shell egg facilities will likely receive guidance and training materials

related to HACCP and sanitation standards.

Page 13 GAO-04-588T

pose a risk of BSE. One, the U.S. Customs and Border Protection, screens

all goods entering the United States to enforce its laws and the laws of 40

other agencies. The second, USDA’s Animal and Plant Health Inspection

Service (APHIS), protects livestock from animal diseases by monitoring

the health of domestic and imported livestock.7 The third, USDA’s FSIS,

monitors the safety of imported and domestically produced meat and, at

slaughterhouses, tests animals prior to slaughter to determine if they are

free of disease and safe for human consumption. Finally, FDA monitors

the safety of animal feed—animals contract BSE through feed that

contains protein derived from the remains of diseased animals. During the

recent discovery of an infected cow in Washington state, FDA investigated

facilities that might have handled byproducts from the infected animal to

make animal feed. Figure 6 illustrates the fragmentation in the agencies’

authorities.

7On March 1, 2003, APHIS’s Agriculture Quarantine and Inspection force became part of the

Department of Homeland Security.

Page 14 GAO-04-588T

Figure 6: Federal Government Agencies Involved in Bovine Spongiform Encephalopathy (BSE) Oversight

When we issued our report in 2002, BSE had not been found in U.S. cattle.

However, we found a number of weaknesses in import controls. Because

of those weaknesses and the disease’s long incubation period—up to 8

years—we concluded that BSE might be silently incubating somewhere in

the United States. Then, in May 2003, an infected cow was found in

Canada, and in December 2003, another was found in the state of

Washington. USDA’s Animal and Plant Health Inspection Service operates

the surveillance program that found the infected U.S. cow, while FDA

must ensure that the disease cannot spread by enforcing an animal feed

ban that prohibits the use of cattle brains and spinal tissue, among other

things, in cattle feed. With regard to the meat from the BSE-infected

Page 15 GAO-04-588T

animal found in Washington state, FSIS conducted a recall of meat

distributed in markets in six states. Both USDA and FDA have reported

that meat from the cow was not used in FDA-regulated foods. However,

had the meat been used, for example, in canned soups that contained less

than 2 percent meat, FDA—not FSIS—would have been responsible for

working with companies to recall those foods. (As app. II shows, the

agencies’ oversight responsibilities for food products vary depending on

the amount of beef or poultry content.) Neither FDA nor USDA has

authority under existing food safety laws to require a company to recall

food products.8 Both agencies work informally with companies to

encourage them to initiate a recall, but our ongoing work shows that each

agency has different approaches and procedures. This can be confusing to

food processors involved in a recall. Overlapping responsibilities in

responding to mad cow disease highlight the challenges that government

and industry face when responding to the need to remove contaminated

food products from the market. As part of work currently underway, we

are looking at USDA and FDA food recalls—including USDA’s oversight of

the BSE-related recall and FDA’s oversight of the feed ban. We are also

monitoring both USDA’s and FDA’s BSE-response activities.

There are undoubtedly other federal food safety activities where overlap

and duplication may occur. For example, in the areas of food safety

research, public outreach, or both FDA, and USDA’s Economic Research

Service, FSIS and the Cooperative State Research, Education and

Extension Service have all received funding to develop food safety-related

educational materials for the public. In addition, responsibility for

regulating genetically modified foods is shared among FDA, USDA, and

the Environmental Protection Agency (EPA). However, we have not yet

examined the extent to which these and other areas of overlap and

duplication impact the efficiency of the food safety system.

8FDA, however, does have legislative authority to require recalls that involve infant

formula.

The fragmented legal and organizational structures of the federal food

safety system are now further challenged by the realization that American

farms and food are vulnerable to potential attack and deliberate

contamination. As we recently reported in a statement for the record

before the Senate Committee on Governmental Affairs,9 bioterrorist

attacks could be directed at many different targets in the farm-to-table

continuum, including crops, livestock, food products in the processing and

Emerging Terrorist

Threats Highlight the

Need to Reorganize

the Federal Food

Safety System

snip...

http://www.gao.gov/new.items/d04588t.pdf

Docket No: 02-088-1 RE-Agricultural Bioterrorism Protection Act of
2002; [TSS SUBMISSION ON POTENTIAL FOR BSE/TSE & FMD 'SUITCASE BOMBS'] -
TSS 1/27/03 (0)

Docket Management

Docket: 02N-0276 - Bioterrorism Preparedness; Registration of Food Facilities, Section 305
Comment Number: EC-254 [TSS SUBMISSION]

http://www.fda.gov/ohrms/dockets/dockets/02n0276/02N-0276-EC-254.htm


GAO says US barriers to mad cow disease are full of holes
Robert Roos News Editor


Note: This story was updated March 1, 2002, to include additional information about recent federal actions to prevent mad cow disease.

Feb 28, 2002 (CIDRAP News) – Congress's General Accounting Office (GAO) concludes in a new report that the United States remains vulnerable to bovine spongiform encephalopathy (BSE), or mad cow disease, because of inadequate import barriers and weak enforcement of rules to contain any BSE-contaminated products that might reach US shores.

"The continuing absence of BSE in the United States today cannot be sufficiently ensured by current federal prevent efforts," states the report, released Feb 26. "The introduction and spread of BSE in the United States could stem from cattle and cattle-derived products from countries that subsequently developed BSE and from gaps in import controls, animal testing, and feed ban enforcement. As a result of these problems, consumers may unknowingly eat foods that contain central nervous system tissue from a diseased animal."

The report says that about 1,000 cattle and 125 million pounds of beef entered the United States from countries that later found cases of BSE. Further, hundreds of firms have violated a ban on putting meat and bone meal in cattle feed, and the Food and Drug Administration (FDA) has done little to enforce the ban, the GAO says.

The GAO investigated the government's BSE prevention efforts at the request of Sens. Tom Harkin, D-Iowa, Richard Lugar, R-Ind., and Dick Durbin, D-Ill. Durbin promised to introduce a bill to strengthen BSE prevention efforts. "We can't have the world's most reliable food supply without an equally reliable system of regulation and oversight," Durbin said in a Feb 26 news release.

Agriculture Secretary Ann Veneman took issue with the report on several counts, saying the GAO didn't fully consider recent actions that federal agencies have taken to strengthen BSE safeguards. She also said the GAO didn't appropriately recognize a Harvard University report issued last year that determined the risk of BSE in the United States to be very low.

Eating meat from animals with BSE is considered a risk factor for variant Creutzfeldt-Jakob disease in humans. BSE prevention steps in the United States began in 1989 with a ban on the importation of live ruminants (cattle, sheep, and goats) and ruminant meat and bone meal from the United Kingdom and other countries with BSE. In 1997 the ban was extended to the rest of Europe, and the FDA banned the use of most mammalian protein in feed for ruminants the same year. In addition, the FDA and the US Department of Agriculture (USDA) screen cattle-derived, FDA-regulated products imported from countries where BSE exists, the GAO report says.

Over the past 20 years, the nation imported about 1,000 cattle, 125 million pounds of beef, and 23 million pounds of inedible meat byproducts from countries where BSE was later found, the GAO determined. Some contaminated animals or products may have entered the country because BSE's incubation period is up to 8 years, the report says.

In particular, the nation imported 242 cattle from Japan between 1993 and 1999. After Japan reported its first BSE cases in September 2001, the USDA managed to locate most of the imported cattle, but 24 animals had already gone to slaughter or rendering.

"In addition to the BSE risk posed by past imports, a small but steady stream of BSE-risk material may still be entering the United States through international bulk mail," the GAO says. USDA inspectors at international bulk mail facilities can spot organic matter with special x-ray scanners, but inspectors are not on duty at all times and they can screen only a fraction of the stream of incoming packages, the report states. In a 6-month period last year, 570 of 116,000 packages screened at one facility contained "at-risk beef or beef-derived products."

Risky items also can slip through federal ports of entry when shipments are inaccurately labeled or through lack of inspection, the GAO reported. For example, sampling by the US Customs Service in fiscal 1999 showed that information on beef shipments was wrong in over 21% of cases. Further, in fiscal year 2000 the FDA inspected only 1% of the 4 million imported food entries under its jurisdiction and less than 1% of the 146,000 shipments of animal drugs and feeds.

BSE prevention efforts also include USDA testing of cattle tissue. The GAO says the USDA has increased its testing program but does not test many cattle that die on farms, which are assumed to pose an increased risk because they are usually older and often die of unknown causes. Some cattle that die on farms are collected and rendered into products that include animal feed, the report says.

The GAO finds serious fault with the FDA's enforcement of the ban on mammalian protein in cattle feed. Since 1997, FDA and state personnel have conducted more than 12,000 inspections at more than 10,576 firms (eg, renderers, feed mills) and found 364 firms in violation, the report states. The FDA estimates that at least another 1,200 firms that should be subject to the ban have not been identified.

"FDA did not take prompt enforcement action to compel firms to comply with the feed ban," the GAO says. By April 2001 (when the GAO investigation began), the agency's only enforcement steps had been to issue two warning letters, though the pace picked up after that. Several firms repeatedly violated the rules but did not receive warning letters. Further, the FDA has no overall enforcement strategy that sets penalties and deadlines.

"Even if FDA were to actively enforce the federal ban, its inspection database is so severely flawed that—until corrected—it should not be used to assess compliance," the report says. It includes a long list of problems with the database; for example, entries for about 45% of all inspections lack information to uniquely identify the firms inspected.

In other findings, the GAO concluded that the United States acted as much as 5 years earlier than other countries to bar imports of animals and animal feed ingredients from countries with BSE cases. However, the nation has a "more permissive" feed ban than other countries in that cattle feed can contain protein from horses and pigs. The FDA is currently reviewing this provision, the report notes.

The report recommends a number of steps to address the problems it describes. Among other things, it suggests that the secretary of agriculture consider using public service announcements or labels to inform consumers that certain beef cuts and products may contain central nervous system (CNS) tissue. The GAO also suggests that the FDA consider requiring labeling of regulated products, including food, cosmetics, and drugs, that contain CNS tissue.

Agriculture Secretary Veneman critiqued the GAO report in a statement released the same day (Feb 26). "The report fails to appropriately recognize the conclusions and recommendations made last year by Harvard University in its comprehensive, 3-year study on BSE," she said. "The Harvard Risk Analysis showed that the risk of BSE occurring in the Untied States is extremely low and that early government protection systems have been largely responsible for keeping BSE out of the United States and would prevent it from spreading if it ever did enter the country."

Veneman also said that despite extensive USDA comments on the draft report, "scientific and technical errors" survived in the final report. Further, the report "does not appropriately consider the additional actions that have been taken by federal agencies to strengthen BSE programs," she added.

The USDA described a number of recent actions related to BSE in a separate news release (see link below). That release says the FDA has "significantly improved" its database on firms' compliance with the animal feed rule. The improved database will be fully operational in April and will allow the FDA to track compliance more effectively, officials said. In addition, the FDA is receiving an extra $15 million for BSE prevention efforts this year, bringing the total to $19 million, and is hiring 115 people this year to help in those efforts.

The USDA also issued a set of responses to the recommendations in the GAO report. The agency rejected the idea of labeling beef and beef products that may contain CNS tissue, stating, "The presence of CNS tissue does not mean that the product is infectious for BSE. Labeling and warning statements should be reserved for known hazards."

In response to another GAO recommendation, the USDA said it is already increasing its testing of tissue samples from animals that die on farms. The agency said that the number of cattle brains tested this year will be more than double last year's total, and that "A focus of this increased surveillance is to obtain more samples from animals that die on farms."

Regarding the Harvard study of BSE risk in the United States, the GAO report says the agency did not try to validate the model or assumptions used by the Harvard researchers. However, the report says the Harvard authors acknowledged that their conclusions "could be influenced by a number of model assumptions that could not be verified with confidence—including assumptions about US measures to prevent the introduction and spread of BSE." The Harvard researchers also noted that compliance with the animal feed ban is the leading source of uncertainty in their assessment, the GAO report states. ...

http://www.cidrap.umn.edu/cidrap/content/other/bse/news/gaorept.html

October 31, 2002

Review of the Evaluation of the

Potential for Bovine Spongiform

Encephalopathy in the United States

Conducted by the Harvard Center for Risk Analysis,

Harvard School of Public Health and Center for

Computational Epidemiology, College of Veterinary

Medicine, Tuskegee University

Final Report

Prepared for

U.S. Department of Agriculture

Food Safety and Inspection Service

Office of Public Health and Science

Prepared by

RTI

Health, Social, and Economics Research

Research Triangle Park, NC 27709

RTI Project Number 07182.024

RTI Project Number

07182.024

Review of the Evaluation of the

Potential for Bovine Spongiform

Encephalopathy in the United States

Conducted by the Harvard Center for Risk Analysis,

Harvard School of Public Health & Center for

Computational Epidemiology, College of Veterinary

Medicine, Tuskegee University

Final Report

October 31, 2002

Prepared for

U.S. Department of Agriculture

Food Safety and Inspection Service

Office of Public Health and Science

Prepared by

RTI

Health, Social, and Economics Research

Research Triangle Park, NC 27709

snip...

9.1 KEY SOURCES OF VARIABILITY AND

UNCERTAINTY

1) In Section 3.2 of the H-T BSE study report, the authors list 15

sources of uncertainty that they evaluated individually for influences

on the model predictions for two outcomes:

Z the total number of cattle that become infected after the

introduction of 10 infected animals at the beginning of the

period, and

Z the amount of BSE infectivity (quantified in terms of the

number of cattle oral ID50s) in food produced for human

consumption over that period.

In addition to varying the parameters to reflect a best case and

worse case, the authors considered the impact of different sources

of infection on the model’s predictions, described in Section 3,

Pages 71-79 and compared the model’s predictions with alternative

9-1

Review of the Evaluation of the Potential for Bovine Spongiform Encephalopathy in the United States — Final Report

scenarios. The parameters evaluated in the sensitivity (uncertainty)

analysis are listed in detail in the synopsis.

2) The method used for evaluating the contributions of

uncertainty in inputs to uncertainty in model predications has key

shortcomings. The chosen method in the BSE risk assessment model

is to evaluate the influence of one individual uncertainty source

while setting all of the other assumptions or uncertainty sources to

their base-case values. For example, when considering the impact

of the uncertainty in maternal BSE transmission rate on the model

prediction, the other 14 uncertainty sources are set to their basecase

point estimates. This kind of analysis should be referred to as

"sensitivity analysis," not as "uncertainty analysis" as described in

the report. Although uncertainty analysis and sensitivity analysis are

closely related, they are two different disciplines. Uncertainty

analysis assesses the uncertainty in model outputs that derives from

uncertainty in all inputs when simulated simultaneously. Sensitivity

Analysis assesses the contributions of the inputs to the total

uncertainty in analysis outcomes (Cullen and Frey, 1999).

Therefore, the results from the BSE model "uncertainty analysis" do

not represent the full range of uncertainty in the risk of animal or

human exposed to BSE associated with simultaneous contributions

from all uncertainty inputs. Instead, what is reported is an

individual contribution of one uncertainty input to the partial

uncertainty in the model output, the risk such as associated with

animal or human exposure to BSE.

3) Variability refers to the heterogeneity of values with respect

to time, space, or a population. For example, in exposure

assessment, variable quantities include the rate at which individuals

consume specific dietary items and the body weights of the

individuals (Cullen and Frey, 1999). Variability can be represented

by a frequency distribution showing the variation in a characteristic

of interest over time, space. Uncertainty arises due to lack of

knowledge regarding the true value of a quantity. For example,

there may be uncertainty regarding the proportion of animals that

die on the farm that are rendered. Uncertainty can be quantified as

a probability distribution representing the likelihood that the

unknown quantity falls within a given range of values (Frey, 1997).

Although the BSE model evaluates the impact of how comparison of

various uncertainty sources influences the model predication, there

9-2

Section 9 — Identification and Characterization of Variability, Uncertainty,

Critical Assumptions, and Data Gaps

is no distinction between variability and uncertainty in the model

inputs or outputs. In typical practice, in an exposure or risk

assessment model, the model inputs can be divided into those that

are variable, those that are uncertain, and those with some aspects

of each (Bogen and Spear, 1987; IAEA, 1989; Morgan and Henrion,

1990; Finkel, 1990; Frey, 1992). For example, in the BSE model,

maternal BSE transmission rate is variable across different mothers,

but it is also uncertain because there is no knowledge regarding its

true value. It is not possible to determine whether there are

variables that are misspecified as uncertain that instead should have

been arranged distribution for variability because there is not

enough description of the characteristics of most of the input

variables. Therefore, based upon the information presented in the

model documentation, it is not possible to determine which inputs

should be arranged distributions for variability and/or uncertainty.

Variability and uncertainty have different ramifications for decisionmakers

(Cullen and Frey, 1999). Uncertainty forces decisionmakers

to judge how probable it is that risks will be overestimated

or underestimated for every member of the exposed population,

whereas variability forces them to cope with the certainty that

different individuals will be subjected to risks both above and below

any reference point one chooses (NRC, 1994). Therefore, it is

recommended that both sources of variability and uncertainty be

identified and distinguished and that variability and uncertainty

analysis be done in the BSE risk assessment model.

4) In Section 2, at the beginning of Page 26, the authors state

the uncertainty in ascertaining the potential risk posed by oral

exposure to Chronic Wasting Disease (CWD):

Ascertaining the potential risk posed by oral

exposure to CWD is further complicated by the

following sources of uncertainty. First, there are no

accurate statistics documenting the number or type

of deer and elk killed by hunters. Second, the type

of deer and elk that can be hunted in different

geographic areas varies. Third, the disposition of

deer and elk remains after slaughter is uncertain.

Finally, the prevalence of the disease in all but the

highest risk areas is unknown.

The authors have found no data for key sources of uncertainty.

9-3

Review of the Evaluation of the Potential for Bovine Spongiform Encephalopathy in the United States — Final Report

5) On Page 55 at the end of the first paragraph, the authors

state, "Our base case assumes that clinical BSE cases would be

detected at AM inspection 90 percent of the time. Because this

value is highly uncertain, our uncertainty analysis evaluates the

impact of using a wide range of values on the results of our

simulation (see Section 3.2.2)." However, it was found that only

two values were evaluated.

6) Table 2.18-1 (Appendix 1, Page 31) specifies joint

probability as a percentage but Table 2.2.2.3 (Appendix 2, Page 8)

specifies it as a probability. (Also, the reviewers wonder if the

decimal point is in the correct place.) Consistency among the units

or measures of the probability would be nice.

7) The authors have done a sensitivity analysis where they

altered the parameter values one at a time to determine the effect on

the model’s predictions, varied values defining the source of

infectivity to determine the effect on the model’s predictions, and

compared the model’s prediction for other scenarios. These are all

important means to determine the model’s behavior and reliability.

The sources of variability are largely only considered individually,

so synergistic effects cannot be assessed. The authors have been

careful to select "reasonable" values for the best and worst cases,

but allowing a greater range of variability would provide a better

understanding of the behavior of the model and its stability.

8) Key sources of variability that have been omitted are

accidents that can sometimes happen and the intentional

introduction of prions to feed or water; and a long-term change in

practices by producers, processing establishments, and/or renderers

that might result in prolonged exposure. Because of these

omissions, one may wonder whether a more parsimonious model

might be as predictive.

9) In the case of variability and uncertainty, the risk of infection

through imported animals is addressed in a defensible manner, even

though the probability of this incursion is not estimated. However,

the age at infection ignores the information and the uncertainty of

the incubation period and is not addressed. The summary of these

aspects, perhaps somewhat harshly, is that the synthesis and critical

review of the literature needs more attention.

9-4

Section 9 — Identification and Characterization of Variability, Uncertainty,

Critical Assumptions, and Data Gaps

10) Little information regarding the distributions of BSE model

inputs and simulation techniques was provided for the so-called

"uncertainty analysis." Therefore, key questions that should be

addressed include the following: (1) How was the value of an input

altered? (2) What sampling techniques were used? It is necessary to

clearly list the distribution assumptions and parameters (if used) and

to clearly describe related simulation techniques when doing

uncertainty analysis. The description in the report regarding the

"uncertainty analysis" of the BSE model is not clear enough for users

or reviewers to understand how the "uncertainty analysis" (if any) is

done.

9.2 CRITICAL ASSUMPTIONS

1) Surveillance efficiency, recognition rate of "clinical cases,"

and level of inactivation by local rendering are overestimated. Also,

with respect to recognition rate (where only the very typical cases

will be recognized), it is assumed that 90 percent (in the case of

worst case, 50 percent) of the BSE clinical cases will be detected in

the ante-mortem inspection, which is way off from the general

feeling in the EU on this topic.

2) In discussing fracContaminate on Page 16, Appendix 1, the

authors state that flushing and cleaning leave only 0.1 percent of the

prohibited material behind. This cross-contamination as compared

to European demonstrated rates is grossly underestimated, unless

flushing and cleaning are done in a very different (and probably

uneconomical) way.

3) The readability of the report could be improved by

tabulating all assumptions, as was done for the slaughter process

assumptions (Table 3-8, Page 68) and the render and feed

production assumptions (Table 3-9, Page 69). On Page 67 (second

paragraph, first line), the authors refer to 15 sets of assumptions, but

present only seven bullets (does a bullet represent a set?). If each

item within a bullet is summed, 17 assumptions can be identified.

Also, the authors set parameters to three values: base case, best

case, and worst case. But the justification for the specific values

assigned is weak, because little data are available. Without hard

data, the detailed list of assumptions for this process has heuristic

9-5

Review of the Evaluation of the Potential for Bovine Spongiform Encephalopathy in the United States — Final Report

value but does not particularly strengthen the predictive value of the

model.

4) The authors assume that "conditions affecting the spread of

BSE in the U.S. would remain unchanged for the 20 years following

its introduction" (Executive summary, Page i, third paragraph, sixth

line). This is a huge assumption and probably unrealistic. As with

most agents of disease, especially newly discovered agents

(emerging diseases), prevalence increases over time largely because

of more and improved testing over time. This has not been

incorporated into the model. Often, agents, once thought rare, are

found to be ubiquitous (e.g., E. coli O157:H7). The public health

goal then is to prevent the agents from spreading or accumulating in

critical locations, including animals, during critical periods of time.

9.3 IMPORTANT DATA GAPS

1) The authors state, "There exist considerable data gaps for

many important model assumptions" (Page 87). The authors have

done a commendable job of incorporating the available data, but

this also has limited the scope of the model and/or has resulted in

giving certain factors more weight (a larger contribution to the

results) than perhaps is warranted.

2) On Pages 22 and 23 the introduction risks are discussed.

The import of risk material from the UK is assessed properly, but the

import of risk material from third countries seems largely ignored.

The EU concluded long ago that lots of risk material from the UK

was transported via third countries. Switzerland, for example,

mainly got infected via France not directly from the UK. Thus, the

introduction risk is probably underestimated, although it is plausible

that this risk still remains very low.

3) An analysis of all imported MBM and feed in the 1980s

would be welcomed. Confirming evidence that imported MBM was

only used in pet food would also be useful.

4) "Tallow" at least deserves some more comments (Page 34),

given the fact that traces of protein are certainly in there and that

international flow of these products is even more difficult to

quantify.

9-6 ...

snip...

full text 132 pages of what USDA DID NOT TELL YOU AND DID NOT WANT YOU TO KNOW;

SUPPRESSED PEER REVIEW OF HARVARD STUDY OCTOBER 31, 2002

http://www.fsis.usda.gov/oa/topics/BSE_Peer_Review.pdf

a

February 2005 MAD COW DISEASE

FDA’s Management of

the Feed Ban Has

Improved, but

Oversight Weaknesses

Continue to Limit

Program Effectiveness

GAO-05-101

What GAO Found

United States Government Accountability Office

Why GAO Did This Study

Highlights

Accountability Integrity Reliability

www.gao.gov/cgi-bin/getrpt?GAO-05-101.

To view the full product, including the scope

and methodology, click on the link above.

For more information, contact Robert A.

Robinson at (202) 512-3841 or

robinsonr@gao.gov.

Highlights of GAO-05-101, a report to

congressional requesters

February 2005

MAD COW DISEASE

FDA’s Management of the Feed Ban Has

Improved, but Oversight Weaknesses

Continue to Limit Program Effectiveness

FDA has made needed improvements to its management and oversight of the

feed-ban rule in response to GAO’s 2002 report, but program weaknesses

continue to limit the effectiveness of the ban and place U.S. cattle at risk of

spreading BSE. Improvements made include FDA establishing a uniform

method of conducting compliance inspections and training FDA inspectors,

as well as state inspectors who carry out inspections under agreements with

FDA, on the new method. FDA also implemented new data-entry procedures

that are designed to more reliably track feed-ban inspection results.

Consequently, FDA has a better management tool for overseeing compliance

with the feed-ban rule and a data system that better conforms to standard

database management practices. However, various program weaknesses

continue to undermine the nation’s firewall against BSE. For example:

• FDA acknowledges that there are more feed manufacturers and

transporters, on-farm mixers, and other feed industry businesses that are

subject to the feed ban than the approximately 14,800 firms inspected to

date; however, it has no uniform approach for identifying additional

firms.

• FDA has not reinspected approximately 2,800, or about 19 percent, of

those businesses, in 5 or more years; several hundred are potentially

high risk. FDA does not know whether those businesses now use

prohibited material in their feed.

• FDA’s feed-ban inspection guidance does not include instructions to

routinely sample cattle feed to test for potentially prohibited material as

part of the compliance inspection. Instead, it includes guidance for

inspectors to visually examine facilities and equipment and review

invoices and other documents.

• Feed intended for export is not required to carry a caution label "Do not

feed to cattle or other ruminants," when the label would be required if

the feed were sold domestically. Without that statement, feed containing

prohibited material could be inadvertently or intentionally diverted back

to U.S. cattle or given to foreign cattle.

• FDA has not always alerted USDA and states when it learned that cattle

may have been given feed that contained prohibited material. This lapse

has been occurring even though FDA’s guidance calls for such

communication.

• Although research suggests that cattle can get BSE from ingesting even a

small amount of infected material, inspectors do not routinely inspect or

review cleanout procedures for vehicles used to haul cattle feed.

More than 5 million cattle across

Europe have been killed to stop the

spread of bovine spongiform

encephalopathy (BSE), commonly

called mad cow disease. Found in

26 countries, including Canada and

the United States, BSE is believed

to spread through animal feed that

contains protein from BSE-infected

animals. Consuming meat from

infected cattle has also been linked

to the deaths of about 150 people

worldwide. In 1997, the Food and

Drug Administration (FDA) issued

a feed-ban rule prohibiting certain

animal protein (prohibited

material) in feed for cattle and

other ruminant animals. FDA and

38 states inspect firms in the feed

industry to enforce this critical

firewall against BSE. In 2002, GAO

reported a number of weaknesses

in FDA’s enforcement of the feed

ban and recommended corrective

actions. This report looks at FDA’s

efforts since 2002 to ensure

industry compliance with the feed

ban and protect U.S. cattle.

What GAO Recommends

GAO recommends FDA, among

other things, develop procedures

for finding additional firms subject

to the feed-ban and using tests to

augment inspections. FDA said the

study was thorough but disagreed

on four of nine recommendations.

GAO continues to believe that,

given the discovery of BSE in North

America and the oversight gaps

described in the report, the

recommended actions are needed

to protect U.S. cattle from BSE.

snip...full text ;

http://www.gao.gov/new.items/d05101.pdf

What GAO Found
United States Government Accountability Office
Why GAO Did This Study
Highlights
Accountability Integrity Reliability
www.gao.gov/cgi-bin/getrpt?GAO-05-549T.
To view the full product, including the scope
and methodology, click on the link above.
For more information, contact Robert A.
Robinson at (202) 512-3841 or
robinsonr@gao.gov.
Highlights of GAO-05-549T, a testimony to
the Subcommittee on the Federal
Workforce and Agency Organization,
Committee on Government Reform,
House of Representatives

May 17, 2005
OVERSEEING THE U.S. FOOD SUPPLY

Steps Should Be Taken to Reduce
Overlapping Federal Inspections and
Related Activities

USDA and FDA have primary responsibility for overseeing the safety of the
U.S. food supply; the Environmental Protection Agency (EPA) and the
National Marine Fisheries Service also play key roles. In carrying out their
responsibilities, these agencies spend resources on a number of overlapping
activities, particularly inspection/enforcement, training, research, and
rulemaking, for both domestic and imported food. For example, both USDA
and FDA conduct similar inspections at 1,451 dual jurisdiction
establishments—facilities that produce foods regulated by both agencies, as
shown below.
To better manage the fragmented federal system, these agencies have
entered into at least 71 interagency agreements—about a third of them
highlight the need to reduce duplication and overlap or make efficient and
effective use of resources. The agencies do not take full advantage of these
agreements because they do not have adequate mechanisms for tracking
them and, in some cases, do not fully implement them.
Selected industry associations, food companies, consumer groups, and
academic experts disagree on the extent of overlap, on how best to improve
the federal system, and on whether to consolidate food safety-related
functions into a single agency. However, they agreed that laws and
regulations should be modernized to more effectively and efficiently control
food safety hazards.
As GAO recently reported, Canada, Denmark, Ireland, Germany, the
Netherlands, New Zealand, and the United Kingdom also had fragmented
systems. These countries took steps to consolidate food safety functions—
each country modified its food safety laws and established a single
agency to
lead food safety management or enforcement of food safety legislation.

GAO has issued many reports
documenting problems resulting
from the fragmented nature of the
federal food safety system—a
system based on 30 primary laws.
This testimony summarizes GAO’s
most recent work on the federal
system for ensuring the safety of
the U.S. food supply. It provides (1)
an overview of food safety
functions, (2) examples of
overlapping and duplicative
inspection and training activities,
and (3) observations on efforts to
better manage the system through
interagency agreements. It also
provides information on other
countries’ experiences with
consolidation and the views of key
stakeholders on possible
consolidation in the United States.
What GAO Recommends
In the past, GAO has recommended
that the Congress consider
fundamental restructuring to
ensure the effective use of scarce
government resources. In the
report that the Subcommittee is
releasing today, GAO recognizes
that, short of reorganization, other
improvements can be made to help
reduce overlap and duplication and
to leverage existing resources. For
example, the Food and Drug
Administration (FDA) could use
existing authority to commission
U.S. Department of Agriculture
(USDA) inspections of dual
jurisdiction establishments.


http://www.gao.gov/highlights/d05213high.pdf


snip...full text below


http://www.gao.gov/new.items/d05213.pdf

OIG same old song and dance until 2008 ;

Safety and Security: Increasingly we have all come to realize that the world

presents greater threats to our well being as individuals and a citizenry in terms

of health and resources. Challenges such as those related to maintaining a safe

food supply and protecting America’s plants and animals from invasive pests are

critical. Thus, we have established as a strategic goal

"Support USDA in the

enhancement of safety and security measures to protect USDA and

agricultural resources and in related public health concerns." ...

http://www.usda.gov/oig/webdocs/rptstrategicplan.pdf

THE TEXAS GONZALES/PURINA INCIDENT SHOWED THAT 5.5 GRAMS OF
RUMINANT PROTEIN WAS FED TO CATTLE ;

FOR IMMEDIATE RELEASE
P01-05
January 30, 2001
Print Media:
301-827-6242
Broadcast Media:
301-827-3434
Consumer Inquiries:
888-INFO-FDA

FDA ANNOUNCES TEST RESULTS FROM TEXAS FEED LOT

Today the Food and Drug Administration announced the results of tests
taken on feed used at a Texas feedlot
that was suspected of containing meat and bone meal from other domestic
cattle -- a violation of FDA's 1997
prohibition on using ruminant material in feed for other ruminants.
Results indicate that a very low level of
prohibited material was found in the feed fed to cattle.

FDA has determined that each animal could have consumed, at most and in
total, five-and-one-half grams -
approximately a quarter ounce -- of prohibited material. These animals
weigh approximately 600 pounds.

It is important to note that the prohibited material was domestic in
origin (therefore not likely to contain infected
material because there is no evidence of BSE in U.S. cattle), fed at a
very low level, and fed only once. The
potential risk of BSE to such cattle is therefore exceedingly low, even
if the feed were contaminated.

According to Dr. Bernard Schwetz, FDA's Acting Principal Deputy
Commissioner, "The challenge to regulators
and industry is to keep this disease out of the United States. One
important defense is to prohibit the use of any
ruminant animal materials in feed for other ruminant animals. Combined
with other steps, like U.S. Department
of Agriculture's (USDA) ban on the importation of live ruminant animals
from affected countries, these steps
represent a series of protections, to keep American cattle free of BSE."

Despite this negligible risk, Purina Mills, Inc., is nonetheless
announcing that it is voluntarily purchasing all 1,222
of the animals held in Texas and mistakenly fed the animal feed
containing the prohibited material. Therefore,
meat from those animals will not enter the human food supply. FDA
believes any cattle that did not consume
feed containing the prohibited material are unaffected by this incident,
and should be handled in the beef supply
clearance process as usual.

FDA believes that Purina Mills has behaved responsibly by first
reporting the human error that resulted in the
misformulation of the animal feed supplement and then by working closely
with State and Federal authorities.

This episode indicates that the multi-layered safeguard system put into
place is essential for protecting the food
supply and that continued vigilance needs to be taken, by all concerned,
to ensure these rules are followed
routinely.

FDA will continue working with USDA as well as State and local officials
to ensure that companies and
individuals comply with all laws and regulations designed to protect the
U.S. food supply.

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


FACTs ARE STILL,


> THE study has limitations that prevent accurately estimating the
> minimum infective dose for humans, ...


IF .1 gram is lethal for other species, and since this new study
confirms 1 out of 2 transmission
of BSE to primate with 5 gram oral dose, i see this study as being very
very disturbing.
BUT of course i have nothing to gain financially for making such a
statement...

http://www.maddeer.org/audio/BBC4farmingtoday2_1_03.ram

Risk of oral infection with bovine spongiform encephalopathy agent in primates

Corinne Ida Lasmézas, Emmanuel Comoy, Stephen Hawkins, Christian Herzog, Franck Mouthon, Timm Konold, Frédéric Auvré, Evelyne Correia, Nathalie Lescoutra-Etchegaray, Nicole Salès, Gerald Wells, Paul Brown, Jean-Philippe Deslys
Summary The uncertain extent of human exposure to bovine spongiform encephalopathy (BSE)--which can lead to variant Creutzfeldt-Jakob disease (vCJD)--is compounded by incomplete knowledge about the efficiency of oral infection and the magnitude of any bovine-to-human biological barrier to transmission. We therefore investigated oral transmission of BSE to non-human primates. We gave two macaques a 5 g oral dose of brain homogenate from a BSE-infected cow. One macaque developed vCJD-like neurological disease 60 months after exposure, whereas the other remained free of disease at 76 months. On the basis of these findings and data from other studies, we made a preliminary estimate of the food exposure risk for man, which provides additional assurance that existing public health measures can prevent transmission of BSE to man.

Published online January 27, 2005

http://www.thelancet.com/journal/journal.isa

Neurobiology
Adaptation of the bovine spongiform encephalopathy agent to primates and comparison with Creutzfeldt- Jakob disease: Implications for human health
Corinne Ida Lasmézas*,, Jean-Guy Fournier*, Virginie Nouvel*, Hermann Boe*, Domíníque Marcé*, François Lamoury*, Nicolas Kopp, Jean-Jacques Hauw§, James Ironside¶, Moira Bruce, Dominique Dormont*, and Jean-Philippe Deslys*

* Commissariat à l'Energie Atomique, Service de Neurovirologie, Direction des Sciences du Vivant/Département de Recherche Medicale, Centre de Recherches du Service de Santé des Armées 60-68, Avenue du Général Leclerc, BP 6, 92 265 Fontenay-aux-Roses Cedex, France; Hôpital Neurologique Pierre Wertheimer, 59, Boulevard Pinel, 69003 Lyon, France; § Laboratoire de Neuropathologie, Hôpital de la Salpêtrière, 83, Boulevard de l'Hôpital, 75013 Paris, France; ¶ Creutzfeldt-Jakob Disease Surveillance Unit, Western General Hospital, Crewe Road, Edinburgh EH4 2XU, United Kingdom; and Institute for Animal Health, Neuropathogenesis Unit, West Mains Road, Edinburgh EH9 3JF, United Kingdom

Edited by D. Carleton Gajdusek, Centre National de la Recherche Scientifique, Gif-sur-Yvette, France, and approved December 7, 2000 (received for review October 16, 2000)


Abstract

There is substantial scientific evidence to support the notion that bovine spongiform encephalopathy (BSE) has contaminated human beings, causing variant Creutzfeldt-Jakob disease (vCJD). This disease has raised concerns about the possibility of an iatrogenic secondary transmission to humans, because the biological properties of the primate-adapted BSE agent are unknown. We show that (i) BSE can be transmitted from primate to primate by intravenous route in 25 months, and (ii) an iatrogenic transmission of vCJD to humans could be readily recognized pathologically, whether it occurs by the central or peripheral route. Strain typing in mice demonstrates that the BSE agent adapts to macaques in the same way as it does to humans and confirms that the BSE agent is responsible for vCJD not only in the United Kingdom but also in France. The agent responsible for French iatrogenic growth hormone-linked CJD taken as a control is very different from vCJD but is similar to that found in one case of sporadic CJD and one sheep scrapie isolate. These data will be key in identifying the origin of human cases of prion disease, including accidental vCJD transmission, and could provide bases for vCJD risk assessment.


Introduction


snip...

Conclusions

From BSE and vCJD transmissions in nonhuman primates, a number of conclusions can be drawn that are of major importance for human health: (i) human-adapted BSE appears to be a variant of the BSE agent that is more virulent for humans than cattle BSE and is efficiently transmitted by the peripheral route; (ii) the detection of vCJD in unusually young patients is probably not because of a lack of diagnosis of cases in older patients, thus raising the question of the source of human contamination with BSE early in life; and (iii) iatrogenic transmissions from patients with vCJD would be readily recognized by using the same diagnostic criteria as those applied to vCJD [clinical and pathological criteria (27) comprising neuronal loss and gliosis in the thalamus correlated with high MRI signal (28, 29)], whether such contaminations had occurred by the central or i.v. route. Primary and iatrogenic cases of vCJD could be distinguished on the basis of the patient's clinical history.

The risk assessment of biological products of human origin, notably those derived from blood, has been deeply modified by the appearance of vCJD. We confirm that the BSE agent has contaminated humans not only in the U.K. and the Republic of Ireland but also in France, and we show that its pathogenic properties for primates are being enhanced by a primary passage in humans. Considering the flow of potentially contaminated bovine-derived products between 1980 and 1996, it is obvious that further vCJD cases may occur outside the U.K. Thus, and in the light of the present study, it is necessary to sustain worldwide CJD surveillance regardless of national BSE incidence and to take all precautionary measures to avoid iatrogenic transmissions from vCJD.

http://www.pnas.org/cgi/content/full/041490898v1

ANOTHER ONE OF FDAs infamous UNTITLED DOCUMENTS TSEs;

Tissue distribution of bovine spongiform

encephalopathy agent in primates after intravenous

or oral infection

C Herzog, N Saks, N Etchegaray, A Charbonnier, S Freire, D Dormont, J-P

Deslys, C I Lasmezas

http://www.fda.gov/ohrms/dockets/dockets/04n0081/04n-0081-bkg0001-Tab-02-vol2.pdf

BASE in cattle in Italy of Identification of a
second bovine amyloidotic spongiform encephalopathy: Molecular
similarities with sporadic

Creutzfeldt-Jakob disease


http://www.pnas.org/cgi/content/abstract/0305777101v1

Adaptation of the bovine spongiform encephalopathy agent to primates
and comparison with Creutzfeldt- Jakob disease: Implications for
human health

THE findings from Corinne Ida Lasmézas*, [dagger] , Jean-Guy Fournier*,
Virginie Nouvel*,

Hermann Boe*, Domíníque Marcé*, François Lamoury*, Nicolas Kopp [Dagger

] , Jean-Jacques Hauw§, James Ironside¶, Moira Bruce [||] , Dominique

Dormont*, and Jean-Philippe Deslys* et al, that The agent responsible
for French iatrogenic growth hormone-linked CJD taken as a control is
very different from vCJD but is similar to that found in one case of
sporadic CJD and one sheep scrapie isolate;

http://www.pnas.org/cgi/content/full/041490898v1

Characterization of two distinct prion strains
derived from bovine spongiform encephalopathy
transmissions to inbred mice

http://vir.sgmjournals.org/cgi/content/abstract/85/8/2471


1: J Infect Dis 1980 Aug;142(2):205-8


Oral transmission of kuru, Creutzfeldt-Jakob disease, and scrapie to nonhuman primates.

Gibbs CJ Jr, Amyx HL, Bacote A, Masters CL, Gajdusek DC.

Kuru and Creutzfeldt-Jakob disease of humans and scrapie disease of sheep and goats were transmitted to squirrel monkeys (Saimiri sciureus) that were exposed to the infectious agents only by their nonforced consumption of known infectious tissues. The asymptomatic incubation period in the one monkey exposed to the virus of kuru was 36 months; that in the two monkeys exposed to the virus of Creutzfeldt-Jakob disease was 23 and 27 months, respectively; and that in the two monkeys exposed to the virus of scrapie was 25 and 32 months, respectively. Careful physical examination of the buccal cavities of all of the monkeys failed to reveal signs or oral lesions. One additional monkey similarly exposed to kuru has remained asymptomatic during the 39 months that it has been under observation.

PMID: 6997404
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=6997404&dopt=Abstract

greetings,

BLATANT enhancement of lies, deceit, secrecy and cover-up ?

SADLY, we can expect more of the same through 2008. ...

HOW many times are they allowed to change protocols every time they get caught before OIG calls it for what it
is and we see heads start to roll, instead of bodies piling up from incubation period catching up, due to OIG continued warning letters and slap on the wrist?


Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW BSE SAFEGUARDS (comment submission)

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

Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL
IMPORTS FROM CANADA


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


Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION]

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

Docket Management Docket: 02N-0273 - Substances Prohibited From Use in

Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed

Comment Number: EC -10

Accepted - Volume 2


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

PART 2


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

PDF]Freas, William TSS SUBMISSION

File Format: PDF/Adobe Acrobat -

Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary

Sr. [flounder@wt.net] Monday, January 08,200l 3:03 PM freas ...

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

Asante/Collinge et al, that BSE transmission to the 129-methionine

genotype can lead to an alternate phenotype that is indistinguishable

from type 2 PrPSc, the commonest _sporadic_ CJD;

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

Docket Management Docket: 96N-0417 - Current Good Manufacturing Practice
in Manufacturing, Packing, or Holding Dietary Ingredients a
Comment Number: EC -2
Accepted - Volume 7

http://www.fda.gov/ohrms/dockets/dailys/03/Mar03/031403/96N-0417-EC-2.htm


[PDF] Appendices to PL107-9 Inter-agency Working Group Final Report 1-1
File Format: PDF/Adobe Acrobat - View as HTML
Agent, Weapons of Mass Destruction Operations Unit Federal Bureau of
those who provided comments in response to Docket No. ...
Meager 8/18/01 Terry S. Singeltary Sr ...


www.aphis.usda.gov/lpa/pubs/pubs/PL107-9_Appen.pdf

Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION
TO DOCKET 2003N-0312]

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

# Docket No: 02-088-1 RE-Agricultural Bioterrorism Protection Act of
2002; [TSS SUBMISSION ON POTENTIAL FOR BSE/TSE & FMD 'SUITCASE BOMBS'] -
TSS 1/27/03 (0)

Docket Management

Docket: 02N-0276 - Bioterrorism Preparedness; Registration of Food Facilities, Section 305
Comment Number: EC-254 [TSS SUBMISSION]

http://www.fda.gov/ohrms/dockets/dockets/02n0276/02N-0276-EC-254.htm


Dockets Entered On October 2, 2003 Table of Contents, Docket #,
Title, 1978N-0301,

OTC External Analgesic Drug Products, ... EMC 7, Terry S. Singeltary Sr.
Vol #: 1, ...

www.fda.gov/ohrms/dockets/dailys/03/oct03/100203/100203.htm


Daily Dockets Entered on 02/05/03

DOCKETS ENTERED on 2/5/03. ... EMC 4 Terry S. Singeltary Sr. Vol#: 2.
... Vol#: 1.

03N-0009 Federal Preemption of State & Local Medical Device Requireme. ...


www.fda.gov/ohrms/dockets/dailys/03/Feb03/020503/020503.htm


Docket Management

Docket: 02N-0370 - Neurological Devices; Classification of Human Dura Mater

Comment Number: EC -1

Accepted - Volume 1


http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be11.html


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


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


Daily Dockets - 04/10/03

... 00D-1662 Use of Xenotransplantation Products in Humans.
EMC 98 Terry S. Singeltary Sr. Vol#: 3. 01F ...
www.fda.gov/ohrms/dockets/dailys/03/Apr03/041003/041003.htm - 05-20-2003
- Cached


2003D-0186
Guidance for Industry: Use of Material From Deer and Elk In Animal Feed


EMC 1
Terry S. Singeltary Sr.
Vol #:
1

http://www.fda.gov/ohrms/dockets/dailys/03/Jun03/060903/060903.htm


2003D-0186
Guidance for Industry: Use of Material From Deer and Elk In Animal Feed


EMC 7
Terry S. Singeltary Sr.
Vol #:
1

2003D-0186
Guidance for Industry: Use of Material From Deer and Elk In Animal Feed


EMC 7
Terry S. Singeltary Sr.
Vol #:
1


http://www.fda.gov/ohrms/dockets/dailys/03/oct03/100203/100203.htm

01N-0423 Substances Prohibited from use in animal food/Feed Ruminant

APE 5 National Renderers Association, Inc. Vol#: 2

APE 6 Animal Protein Producers Industry Vol#: 2

APE 7 Darling International Inc. Vol#: 2

EMC 1 Terry S. Singeltary Sr. Vol#: 3

http://www.fda.gov/ohrms/dockets/dailys/01/Oct01/101501/101501.htm

TSS






Follow Ups:



Post a Followup

Name:
E-mail: (optional)
Subject:

Comments:

Optional Link URL:
Link Title:
Optional Image URL: