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From: TSS ()
Subject: vCJD Prevention for International Travel, Health Information 2005-2006 CDC
Date: June 23, 2005 at 3:41 pm PST

Traveler's Health: Yellow Book
Health Information for International Travel, 2005-2006
Travelers' Health Home > Yellow Book >
Chapter 4 – Prevention of Specific Infectious Diseases
Bovine Spongiform Encephalopathy and Variant Creutzfeldt-Jakob Disease
Description
Since 1996, strong evidence has accumulated for a causal relationship between ongoing outbreaks in Europe of a disease in cattle called bovine spongiform encephalopathy (BSE, or "mad cow disease") and a disease in humans called variant Creutzfeldt-Jakob disease (vCJD). Both disorders, which are caused by an unconventional transmissible agent, are invariably fatal brain diseases with incubation periods typically measured in years. Transmission of the BSE agent to humans, leading to vCJD, is believed to occur via ingestion of cattle products contaminated with the BSE agent; however, the specific foods associated with this transmission are unknown. Bioassays have identified the BSE agent in the brain, spinal cord, retina, dorsal root ganglia, distal ileum, and bone marrow of cattle experimentally infected by the oral route, suggesting that these tissues represent the highest risk of transmission.

Occurrence
From 1995 through August 2004, 147 human cases of vCJD were reported in the United Kingdom (UK), 7 in France, and 1 each in Canada, Ireland, Italy, and the United States. The patients from Canada, Ireland, and the United States had lived in the UK during a key exposure period of the UK population to the BSE agent. By year of onset, the incidence of vCJD in the UK appears to have peaked in 1999 and to have been declining thereafter. However, the future pattern of this epidemic remains uncertain.

From 1986 through 2001, >98% of BSE cases worldwide were reported from the UK, where the disease was first described. During this same period, the number of European countries reporting at least one indigenous BSE case increased from 4 to18 through 2001. During 2001-2003, three countries outside Europe (Canada, Japan, and Israel) reported their first indigenous BSE cases, and others followed.

The reported BSE incidence rates, by country and year, are available on the Internet website of the Office International des Epizooties and new information is being generated on a regular basis. (http://www.oie.int/eng/info/en_esbincidence.htm).

The identification in 2003 of a BSE case in Canada, and the subsequent identification later that year of a BSE case in the United States that had been imported from Canada led to the concern that indigenous transmission of BSE may be occurring in North America. Safeguards to minimize the risk for human exposure to BSE have been implemented in the United States by the Department of Agriculture (http://aphis.usda.gov/lpa/issues/bse_testing/plan.html).

Transfusion of blood contaminated with the vCJD agent is believed responsible for a few cases of disease in the UK. This prompted the US Food and Drug Administration to publish guidance outlining a geography-based donor deferral policy to reduce the risk of bloodborne transmission of vCJD in the United States. This guidance document included an appendix that listed European countries with BSE or a possible increased risk of BSE for use in determining blood donor deferrals. One deferral criterion was living cumulatively for 5 or more years in continental Europe from 1980 to the present. http://www.aphis.usda.gov/NCIE/country.html#BSE.

Risk for Travelers
The current risk of acquiring vCJD from eating beef (muscle meat) and beef products produced from cattle in countries with at least a possibly increased risk of BSE cannot be determined precisely. Nevertheless, in the UK, the current risk of acquiring vCJD from eating beef and beef products appears to be extremely small, perhaps about 1 case per 10 billion servings. In the other countries of the world, this current risk, if it exists at all, would not likely be any higher than that in the UK if BSE-related, public health control measures are being well implemented. Among many uncertainties affecting this determination are the incubation period between exposure to the infective agent and onset of illness, the sensitivities of each country's surveillance for BSE and vCJD, the compliance with and effectiveness of public health measures instituted in each country to prevent BSE contamination of human food, and details about cattle products from one country distributed and consumed elsewhere. Despite the exceedingly low risk, the US blood donor deferral criteria in effect as of September 2004 focus on the time (cumulatively 3 months or more) that a person lived in the UK from 1980 through 1996, whereas for the rest of Europe the criteria focus on the time (cumulatively 5 years or more) that a person lived in these countries from 1980 through the present.

Prevention
Public health control measures, such as surveillance, culling sick animals, or banning specified risk materials, have been instituted in many countries, particularly in those with indigenous cases of confirmed BSE, in order to prevent potentially BSE-infected tissues from entering the human food supply. The most stringent of these control measures, including a program that excludes all animals >30 months of age from the human food and animal feed supplies, have been applied in the UK and appear to be highly effective. In June 2000, the European Union Commission on Food Safety and Animal Welfare strengthened the European Union's BSE control measures by requiring all member states to remove specified risk materials from animal feed and human food chains as of October 1, 2000; such bans had already been instituted in most member states.

To reduce any risk of acquiring vCJD from food, travelers to Europe or other areas with indigenous cases of BSE may consider either avoiding beef and beef products altogether or selecting beef or beef products, such as solid pieces of muscle meat (rather than brains or beef products like burgers and sausages), that might have a reduced opportunity for contamination with tissues that may harbor the BSE agent. These measures, however, should be taken with the knowledge of the very low risk of transmission as defined above. Milk and milk products from cows are not believed to pose any risk for transmitting the BSE agent.

Treatment
As of September 2004, treatment of prion diseases remains supportive; no specific therapy has been shown to stop the progression of these diseases.

Bibliography
Belay ED, Schonberger LB. The public health impact of prion diseases. Annu Rev Public Health 2005; 26:in press.
Centers for Disease Control and Prevention. Bovine spongiform encephalopathy in a dairy cow — Washington state, 2003. MMWR 2003;52:1280-1285.
Llewelyn CA, Hewitt PE, Knight RSG, et al. Possible transmission of variant Creutzfeldt-Jakob disease by blood transfusion. Lancet 2004;363:417-421.
Peden AH, Head MW, Ritchie DL, et al. Preclinical vCJD after blood transfusion in a PRNP codon 129 heterozygous patient. Lancet 2004;264:527-529.
Will RG, Alpers MP, Dormont D, Schonberger LB. Infectious and sporadic prion diseases. In: Prusiner SB, ed. Prion Biology and Diseases, 2nd Ed., Cold Spring Harbor Laboratory Press, Cold Spring Harbor, New York, 2004: 629-671.
-Lawrence B. Schonberger, Ermias D. Belay, James J. Sejvar

Important: For current travel notices, such as outbreak and travel precaution advisories, and additional recommendations, see this site's Destinations section.

http://www2.ncid.cdc.gov/travel/yb/utils/ybGet.asp?section=dis&obj=madcow.htm


SEEMS, Lawrence B. Schonberger, Ermias D. Belay, James J. Sejvar fail to mention the risk from North America
and BSE/TSE. SO, for traveler's to the USA;



EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of the United States of America (USA)
Publication date: 20 August 2004
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.


http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/573_en.html


CANADA

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/563/sr02_biohaz02_canada_report_annex_en1.pdf

MEXICO

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/566/sr04_biohaz02_mexico_report_annex_en1.pdf



European Food Safety Authority
20 August 2004
PRESS RELEASE
EFSA publishes Geographical BSE-Risk (GBR) assessments for
Australia, Canada, Mexico, Norway, South Africa, Sweden
and the United States of America
The European Food Safety Authority (EFSA) has issued today seven up-to-date
scientific reports on the Geographical Bovine Spongiform Encephalopathy (BSE)
Risk (GBR) assessments for Australia, Canada, Mexico, Norway, South Africa
Sweden and the United States of America. While Australias GBR level I (i.e.
presence of BSE in domestic cattle is highly unlikely) is maintained, that of Norway
has been raised to level II (presence of BSE unlikely but not excluded), Sweden
remains at GBR level II and those of Canada and the United States have been raised
to level III (presence of BSE likely but not confirmed, or confirmed at a lower level)
following a new assessment taking into account the most recent evidence. EFSAs
Scientific Expert Working Group on geographic BSE risk assessment also evaluated
the status of Mexico and South Africa which were classified as level III.
In 2003 EFSA was requested by the European Commission (EC) to re-assess the
Geographical Bovine Spongiform Encephalopathy (BSE) risk (GBR) for 13 countries:
Australia, Botswana, Canada, Costa Rica, El Salvador, Nicaragua, Namibia, Norway,
Mexico, Panama, Swaziland, Sweden and the United States. Although the European
Commission did not specifically seek advice from EFSA relating to the appearance of
BSE in South Africa, the working group decided to carry out a risk assessment for this
country under a self-tasking mandate in order to allow for a meaningful evaluation of the
three other countries in the Southern African Region for which a GBR assessment was
requested (i.e. Botswana, Namibia, Swaziland). EFSAs Scientific Expert Working
Group on the Assessment of the GBR has completed to date those assessments relating to
Australia, Canada, Mexico, Norway, South Africa, Sweden and the United States of
America. The GBR assessments for the remaining countries will be finalized by the end
of 2004.
In conducting the GBR assessments, EFSAs GBR working group followed the
methodology developed by the former Scientific Steering Committee of DG Health and
Consumer Safety (DG SANCO) of the European Commission which is described in its
final opinion on GBR assessment1. The risk assessments published today are based on
up-to-date data provided by the countries concerned as well as other sources of data (i.e.
Eurostat and country export data) covering the period of 1980 to 2003.
A detailed analysis for each country is presented in the Scientific Reports which can be
found at:

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



From: Terry S. Singeltary Sr. [flounder@wt.net]
Sent: Tuesday, July 29, 2003 1:03 PM
To: fdadockets@oc.fda.gov
Cc: ggraber@cvm.fda.gov; Linda.Grassie@fda.gov; BSE-L
Subject: Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION
TO DOCKET 2003N-0312]

Greetings FDA,

snip...

PLUS, if the USA continues to flagrantly ignore the _documented_ science to date about the known TSEs in the USA (let alone the undocumented TSEs in cattle), it is my opinion, every other Country that is dealing with BSE/TSE should boycott the USA and demand that the SSC reclassify the USA BSE GBR II risk assessment to BSE/TSE GBR III 'IMMEDIATELY'. for the SSC to _flounder_ any longer on this issue, should also be regarded with great suspicion as well. NOT to leave out the OIE and it's terribly flawed system of disease surveillance. the OIE should make a move on CWD in the USA, and make a risk assessment on this as a threat to human health. the OIE should also change the mathematical formula for testing of disease. this (in my opinion and others) is terribly flawed as well. to think that a sample survey of 400 or so cattle in a population of 100 million, to think this will find anything, especially after seeing how many TSE tests it took Italy and other Countries to find 1 case of BSE (1 million rapid TSE test in less than 2 years, to find 102 BSE cases), should be proof enough to make drastic changes of this system. the OIE criteria for BSE Country classification and it's interpretation is very problematic. a text that is suppose to give guidelines, but is not understandable, cannot be considered satisfactory. the OIE told me 2 years ago that they were concerned with CWD, but said any changes might take years. well, two years have come and gone, and no change in relations with CWD as a human health risk. if we wait for politics and science to finally make this connection, we very well may die before any decisions
or changes are made. this is not acceptable. we must take the politics and the industry out of any final decisions of the Scientific community. this has been the problem from day one with this environmental man made death sentence. some of you may think i am exaggerating, but you only have to see it once, you only have to watch a loved one die from this one time, and you will never forget, OR forgive...yes, i am still very angry... but the transmission studies DO NOT lie, only the politicians and the industry do... and they are still lying to this day...TSS


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


Terry S. Singeltary Sr. P.O. BOX 42 Bacliff, TEXAS USA



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