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From: TSS ()
Subject: Regulation of Dietary Supplements (or the lack of) and TSE aka Transmissible Spongiform Encephalopathy i.e. CJD 2006
Date: March 22, 2006 at 2:21 pm PST

Greetings,


THOUGHT i might go and see what kinda of mad cow goodies still on the market for consumption for humans via the potential route from NUTRITIONAL SUPPLEMENTS, and what no better one to start with than Standard Process Co. i see gw's bse mrr policy mentality has seeped over into the food
and cosmetics i.e. nutritional supplements with the ;

U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
November 14, 2000

Letter to Reiterate Certain Public Health and Safety Concerns to Firms Manufacturing or Importing Dietary Supplements that Contain Specific Bovine Tissues
To: Manufacturers and Importers of Dietary Supplements and Dietary Supplement Ingredients:

The Food and Drug Administration (FDA) is taking this opportunity to reiterate certain public health and safety concerns to firms manufacturing or importing dietary supplements that contain specific bovine tissues. The safety concerns about bovine-derived dietary supplement ingredients, including extracts or substances derived from such tissues, are a result of the fact that bovine-derived ingredients from cattle born, raised, or slaughtered in certain countries present a risk of transmitting the infectious agent that causes bovine spongiform encephalopathy (BSE) to humans consuming such products. FDA strongly recommends that firms should consider the public health consequences of this disease in taking whatever steps are necessary to assure themselves and the public that such ingredients do not come from cattle born, raised, or slaughtered in countries where BSE exists.

Background

BSE is a transmissible neurologic disorder of cattle and is prevalent in certain parts of the world. This neurological disease is one of a number of transmissible spongiform encephalopathies (TSE) known and is similar to other TSEs such as scrapie in sheep and Creutzfeldt-Jakob disease (CJD) in humans. It is believed that the spread of BSE in cattle in some countries, particularly Great Britain, was caused by the feeding of infected cattle and sheep tissues to cattle. While transmission of the causative agent of BSE to humans has not been definitively documented to date, inter-species transfer has been demonstrated (e.g., mice can be infected by exposure to infected bovine tissues). BSE has never been diagnosed in cattle in the United States. However, although steps have been taken to control the spread of BSE in cattle, new cases of BSE continue to be identified in certain European countries. This fact illustrates that serious public health risks associated with the consumption of animal-derived ingredients from animals sourced from BSE-positive countries remain because such tissues may contain the causative agent of BSE.

Recommendations

Although there is still no definitive evidence that the consumption of bovine tissues that contain the transmissible agent for BSE cause CJD in humans, FDA is concerned that appropriate measures to eliminate the use of bovine tissues from BSE-countries be instituted by firms that use bovine-derived ingredients in their products. The list of countries where BSE is known to exist is maintained by the U.S. Department of Agriculture (USDA) and codified in Title 9, Code of Federal Regulations, Part 94.18. Currently, the list of countries in which BSE is know to exist includes Great Britain, France, The Netherlands, Portugal, Luxembourg, Ireland, Switzerland, Oman, and Belgium.

We strongly recommend that firms manufacturing or importing dietary supplements which contain specific bovine tissues (see enclosure), including extracts or substances derived from such tissues, take all steps necessary to assure themselves and the public that such ingredients do not come from cattle born, raised, or slaughtered in countries where BSE exists. FDA believes that any firm using BSE-derived ingredients should take immediate and continued actions to minimize the potential risk of human exposure to the infectious agent that causes BSE in cattle.

We appreciate your attention to and cooperation in this matter. If you need more information or have questions, please contact the Director, Division of Compliance and Enforcement (HFS-810), Office of Nutritional Products, Labeling, and Dietary Supplements, 200 C St., SW, Washington, DC 20204 (telephone 202-205-5229) or your local FDA District Office.


Sincerely,
Christine J. Lewis, Ph.D.
Director
Office of Nutritional Products, Labeling, and Dietary Supplements
Center for Food Safety and Applied Nutrition

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

Enclosure
List of Tissues with Suspected Infectivity(1)

Category I (High infectivity)

brain
spinal cord
Category II (Medium infectivity)

ileum
lymph nodes
proximal colon
spleen
tonsil
dura mater
pineal gland
placenta
cerebrospinal fluid
pituitary gland
adrenal gland
Category III (Low infectivity)

distal colon
nasal mucosa
sciatic nerve
bone marrow
liver
lung
pancreas
thymus gland
List taken from Report of a WHO Consultation on Public Health Issues Related to Animal and Human Spongiform Encephalopathies, World Health Organization, Office of Interantional Epizootics, Geneva, Switzerland, November 12-14, 1991.

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

The absence of a specific tissue, organ, or gland from this list does not mean that such tissue, organ, or gland cannot contain the infectious agent responsible for BSE. It only means that there was not adequate information available at the time to assign the tissue, organ, or gland to a specific category.

[[ I BELIEVE THE SENTENCE DIRECTLY ABOVE WAS ADDED IN WAY AFTER THIS LETTER WAS WRITTEN...TSS]]

http://www.cfsan.fda.gov/~dms/dspltr05.html



Letter to Manufacturers of Biological Products
Recommendations Regarding Bovine Spongiform Encephalopathy (BSE)

Department of Health and Human Services
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

April 19, 2000

To Manufacturers of Biological Products

The Food and Drug Administration (FDA) has issued letters (date May 3, 1991, December 17, 1993, and May 9, 1996) and a guidance document (September 1997) requesting that materials derived from ruminants which have resided in or originated from countries where Bovine Spongiform Encephalopathy (BSE) has been diagnosed not be used in the manufacture of FDA-regulated products intended for administration to humans. The United States Department of Agriculture (USDA) also issued an interim rule on January 6, 1998, restricting the importation of ruminants, meat and meat products from ruminants, and certain ruminant products and byproducts from all countries of Europe. Because of the serious nature of this issue, the Center for Biologics Evaluation and Research (CBER) believes it critical to update the current recommendations.

CBER strongly recommends that manufacturers take whatever steps are necessary to assure that materials derived from all species of ruminant animals born, raised or slaughtered in countries where BSE is known to exist, or countries where the USDA has been unable to assure FDA that BSE does not exist, are not used in the manufacture of FDA-regulated products intended for administration to humans. The Agency has previously recommended that manufacturers take the following steps to prevent this occurrence:


Identify all ruminant-derived materials (e.g., culture medium, transferrin, albumin, enzymes, lipids) used in the manufacture of regulated products. FDA considers the manufacture of biological products to include the preparation of master (including the original cell line) and working cell banks, as well as materials used in fermentation, harvesting, purification and formulation of the products.

Document the country of origin and all countries where the live animal source has resided for each ruminant-derived material used in the manufacture of the regulated product. The regulated-product manufacturer should obtain this information from the supplier of the ruminant-derived product. The regulated-product manufacturer should also obtain the appropriate veterinary regulatory inspection certification of slaughter, as required by the country of origin of live animals, from the supplier. Documentation should be maintained for any new or in-process lots of licensed, cleared or approved products; products pending clearance or approval; and investigational products intended to be administered to humans.

Maintain traceable records for each lot of ruminant material and each lot of FDA-regulated product manufactured using these materials. These records should be part of the product batch records and available for FDA inspection. Such records should be maintained for products manufactured at foreign as well as domestic facilities.
It is the responsibility of the manufacturer to obtain up-to-date information regarding countries where BSE is known to exist, or countries where the USDA has been unable to assure FDA that BSE does not exist. This information is available from the USDA's Animal and Plant Health Inspection Service (APHIS) at telephone number 301-734-8364, website address http://www.aphis.usda.gov/oa/bse/, and codified at 9 CFR 94.18 (see attached).

Specific product-related questions should be directed to the appropriate application division within CBER's product offices. The phone numbers are:

Dr. David Asher, 301-827-3524
Office of Blood Research and Review

Dr. Paul Richman, 301-827-3070
Office of Vaccines Research and Review

James Crim, 301-827-5101
Office of Therapeutics Research and Review

Thank you for your attention to this matter.

Sincerely,

--- signature ---
Kathryn C. Zoon, Ph.D.
Director
Center for Biologics Evaluation And Research

Attachment


Updated May 13, 2002


http://www.fda.gov/cber/ltr/bse041900.htm


Letter to Manufacturers of Biological Products
Recommendations Regarding Bovine Spongiform Encephalopathy (BSE)

§94.18 Restrictions on Importation of Meat and Edible Products From Ruminants Due To Bovine Spongiform Encephalopathy


Bovine spongiform encephalopathy exists in the following regions: Belgium, France, the Republic of Ireland, Liechtenstein, Luxembourg, Oman, The Netherlands, Portugal, Switzerland, and the United Kingdom.

The following regions, because of import requirements less restrictive than those that would be acceptable for import into the United States and/or because of inadequate surveillance, present an undue risk of introducing bovine spongiform encephalopathy into the United States: Albania, Austria, Bosnia-Herzegovina, Bulgaria, Croatia, the Czech Republic, Denmark, the Federal Republic of Yugoslavia, Finland, Germany, Greece, Hungary, Italy, the Former Yugoslav Republic of Macedonia, Norway, Poland, Romania, the Slovak Republic, Slovenia, Spain, and Sweden.

A region may request at any time that the Administrator consider its removal from a list set forth in paragraphs (a)(1) or (a)(2) of this section by following the procedures set forth in §§92.2(b) (1) through (4), 92.2(b) (5) through (11), and 92.2(c) of this chapter.

Except as provided in paragraph (d) of this section, the importation of fresh, frozen, and chilled meat, meat products, and edible products other than meat (excluding gelatin, milk and milk products), from ruminants that have been in any of the countries listed in paragraph (a) of this section is prohibited.

Gelatin. The importation of gelatin derived from ruminants that have been in any region listed in paragraph (a) of this section is prohibited unless the following conditions have been met:

The gelatin must be imported for use in human food, human pharmaceutical products, photography, or some other use that will not result in the gelatin coming in contact with reminants in the United States.

The person importing the gelatin must obtain a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors by filing a permit application on VS form 16-3.17

The permit application must state the intended use of the gelatin and the name and address of the consignee in the United States.

Transit shipment of articles. Fresh (chilled or frozen) meat, and edible products other than meat, that are prohibited importation into the United States in accordance with this section may transit the United States for immediate export if the following conditions are met:

The person moving the articles must obtain a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors by filing a permit application on VS form 16-3.18

The articles must be sealed in leakproof containers bearing serial numbers during transit. Each container must remain sealed during the entire time that it is in the United States.

The person moving the articles shall notify, in writing, the Plant Protection and Quarantine Officer at both the place in the United States where the articles will arrive and the port of export prior to such transit. The notification must include the:

United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors permit number;

Times and dates of arrival in the United States;

Times and dates of exportation from the United States;

Mode of transportation; and

Serial numbers of the sealed containers.

The articles must transit the United States in Customs bond.


(Approved by the Office of Management and Budget under control number 0579-0015)

[56 FR 63868, Dec. 6, 1991, as amended at 58 FR 65104, Dec. 13, 1993; 59 FR 24638, May 12, 1994; 59 FR 67616, Dec. 30, 1994; 62 FR 18264, Apr. 15, 1997; 62 FR 46181, Sept. 2, 1997; 62 FR 56023, Oct. 28, 1997; 62 FR 61434, Nov. 18, 1997; 62 FR 66000, Dec. 17, 1997; 63 FR 408, Jan. 6, 1998; 63 FR 4347, Jan. 28, 1998; 63 FR 71210, Dec. 24, 1998; 64 FR 38550, July 19, 1999]

17 & 18 VS form 16-3 may be obtained from the Animal and Plant Health Inspection Service, Veterinary Services, National Center for Import-Export, 4700 River Road Unit 38, Riverdale, Maryland 20737-1231.


Updated May 13, 2002


http://www.fda.gov/cber/ltr/bseattach.htm

Subject: FDA Amends Interim Final Rule "Use of Materials Derived from Cattle in Human
Date: September 6, 2005 at 8:54 am PST

FOR IMMEDIATE RELEASE
Media Inquiries: Michael Herndon
P05-58
301-827-6242
September 6, 2005
Consumer Inquiries: 888-INFO-FDA


FDA Amends Interim Final Rule "Use of Materials Derived from Cattle in Human
Food and Cosmetics"

The U.S. Food and Drug Administration today published several amendments to
the July 2004 interim final rule, "Use of Materials Derived from Cattle in
Human Food and Cosmetics," that will allow the use of certain cattle-derived
material in human foods and cosmetics.

The rule prohibits the use of cattle-derived materials that can carry the
infectious agent for bovine spongiform encephalopathy (BSE), or mad cow
disease, in human foods, dietary supplements, and in cosmetics. Based on
the scientific information provided during the interim final rule's comment
period, which demonstrates that a part of the cow's digestive tract called
the distal ileum can be consistently and effectively removed from the other
sections of the small intestine, it is no longer necessary to designate the
entire small intestine as a prohibited cattle material.

As a result, FDA is amending the rule to allow use of the small intestine in
human food and cosmetics, provided that the distal ileum has been removed.
The U.S. Department of Agriculture is publishing today a similar amendment
to its interim final rule on BSE.

The amendments also clarify that milk and milk products, hides and
hide-derived products, and tallow derivatives are not prohibited for use in
human food and cosmetics.

Finally, FDA has reconsidered the recommended method for determining
insoluble impurities in a type of solid fat known as tallow, in response to
information submitted to the agency, to cite a method that is less costly to
use and requires less specialized equipment.

FDA issued the interim final rule to minimize human exposure to materials
that studies have demonstrated are highly likely to contain the BSE agent in
cattle with the disease. The amended interim final rule provides the same
level of protection against the agent that causes BSE as the original
provisions.

The amendments to the interim final rule are effective on October 7, 2005
and comments are being are accepted on the amendments through November 7,
2005.

###

http://www.fda.gov/bbs/topics/news/2005/NEW01229.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

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

continuing on;

holy mad cow in a pill, i see they have indeed changed some of the ingredients around, but LOOK at some of the animal organs still used that could potentially expose you to the TSE agent. i have posted the latest and compared to what i posted several years back, and you can see for example they changed the bovine brain to porcine brain, but then left bovine anterior pituitary, daaa. however, we are now indeed finding the agent in the muscle tissue of many species, including humans, bovine, sheep, elk. just check out what is still allowed in these products for humans. i thought for sure they would change this$ NOT to forget, the TSE agent has been
successfully transmitted to pigs by inoculation;


7 OF 10 LITTLE PIGGIES WENT ON TO DEVELOP BSE;

1: J Comp Pathol. 2000 Feb-Apr; 122(2-3): 131-43. Related Articles,

Links

Click here to read

The neuropathology of experimental bovine spongiform encephalopathy
in the pig.

Ryder SJ, Hawkins SA, Dawson M, Wells GA.

Veterinary Laboratories Agency Weybridge, Woodham Lane, New Haw,
Addlestone, Surrey, KT15 3NB, UK.

In an experimental study of the transmissibility of BSE to the pig,
seven of 10 pigs, infected at 1-2 weeks of age by multiple-route
parenteral inoculation with a homogenate of bovine brain from
natural BSE cases developed lesions typical of spongiform
encephalopathy. The lesions consisted principally of severe neuropil
vacuolation affecting most areas of the brain, but mainly the
forebrain. In addition, some vacuolar change was identified in the
rostral colliculi and hypothalamic areas of normal control pigs. PrP
accumulations were detected immunocytochemically in the brains of
BSE-infected animals. PrP accumulation was sparse in many areas and
its density was not obviously related to the degree of vacuolation.
The patterns of PrP immunolabelling in control pigs differed
strikingly from those in the infected animals.

PMID: 10684682 [PubMed - indexed for MEDLINE]

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?holding=npg&cmd=Retrieve&db=PubMed&list_uids=10684682&dopt=Abstract

Title: Experimental Intracerebral and Oral Inoculation of Scrapie to Swine: Preliminary Report


Authors

Greenlee, Justin
Kunkle, Robert
Hamir, Amirali


Submitted to: American Association of Veterinary Laboratory Diagnosticians
Publication Type: Abstract
Publication Acceptance Date: November 5, 2005
Publication Date: November 5, 2005
Citation: Greenlee, J.J., Kunkle, R.A., Hamir, A.N. 2005. Experimental Intracerebral and Oral Inoculation of Scrapie to Swine: Preliminary Report [abstract]. Proceedings of the American Association of Veterinary Laboratory Diagnosticians 48th Annual Conference. P. 38.

Technical Abstract: Transmissible spongiform encephalopathies (TSEs, prion diseases) are chronic neurodegenerative diseases that occur in humans, cattle, sheep, goats, cervids, and a number of laboratory animal models. In a laboratory setting, the host range of a given TSE can be tested by inoculating animals with brain tissue from affected animals through various routes including oral and intracranial. There is no evidence of the natural occurrence of any form of TSE in the pig, but pigs have been shown to be susceptible to bovine spongiform encephalopathy (BSE) infection by multiple-route parenteral challenge. However, pigs orally exposed at eight weeks of age to large amounts of brain from cattle clinically affected with BSE did not support infection after seven years of observation. In the United States, feeding of ruminant by-products to ruminants is prohibited, but feeding of ruminant materials to swine and poultry still occurs. The potential for swine to have access to scrapie-contaminated feedstuffs exists, but the potential for swine to serve as a host for replication/accumulation of the agent of scrapie is unknown. The purpose of this study was to perform oral and intracerebral inoculation of the U.S. scrapie agent to determine the potential of swine as a host for the scrapie agent and their clinical susceptibility. This study utilized 26 swine randomly divided into three groups: controls (n=6), oral inoculates (n=8), and intracranial inoculates (n=12). Brain homogenate (10%) derived from scrapie-affected sheep was given by a single intracranial injection of 0.75 ml or by oral inoculation of 15 ml on four consecutive days. Scrapie inoculum was derived from clinically ill sheep inoculated with material derived from 13 sheep in seven source flocks. A sample of this material was also inoculated back into sheep to assure infectivity. Necropsies were planned for six months post inoculation, at approximately the time the pigs were expected to reach market weight. Samples collected were examined microscopically after routine staining (hematoxylin and eosin) and staining by standard immunohistochemical methods for prion protein (PrP**Sc). After approximately six months incubation time, no histologic lesions suggestive of spongiform encephalopathy or immunohistochemical evidence of prion infection were obtained. No evidence of scrapie infection was demonstrated in this short-term study, but positive results after an incubation period of only six months would be uncharacteristic. The only TSE with an incubation of six months or less known at this time is transmissible mink encephalopathy in mink, skunk, or raccoon hosts. However, scrapie in the raccoon model has a two-year incubation period. A replicate of littermate pigs has been inoculated and will be studied after long-term (3-7 years) incubation, and a similar study is underway with pigs inoculated with material derived from elk, mule deer, and whitetail deer affected by chronic wasting disease (CWD).


Last Modified: 03/19/2006


http://www.ars.usda.gov/research/publications/publications.htm?SEQ_NO_115=180786

confindential
pigs & pharmaceuticals


http://www.bseinquiry.gov.uk/files/yb/1990/09/10007001.pdf

http://www.bseinquiry.gov.uk/files/yb/1990/08/23002001.pdf

http://www.bseinquiry.gov.uk/files/yb/1990/08/23004001.pdf

http://www.bseinquiry.gov.uk/files/yb/1990/08/29003001.pdf


Greetings again,

I think more importantly is the potential for the ruminant protein to be passed to other species via gut of a pig that was rendered and fed ruminant protein beforehand, then once rendered, the TSE agent spreads whether or not pig itself has the disease or not, it's in the gut, thus could be passed via rendering and feeding to other species. ...TSS



Standard Process INC.


Iplex® - Introduced in 1957 and is a member of these product groups: Minerals, Vitamins

Iplex is a special combination formula designed to support the healthy functioning of the eyes. Iplex contains desiccated porcine brain that includes tissue proteins from the pineal gland. †

Content Product No.
150 Capsules 5100

Suggested Use: Two capsules per meal, or as directed.


Proprietary Blend: 967 MG
Arrowroot flour, inositol, calcium lactate, porcine eye PMG™ extract, phosphoric acid, dried buckwheat (leaf) juice, buckwheat (seed), veal bone PMG™ extract, carrot (root), bovine liver, magnesium citrate, porcine stomach, choline bitartrate, nutritional yeast, bovine adrenal, defatted wheat (germ), alfalfa flour, bovine kidney, dried alfalfa juice, allantoin, mushroom, manganese glycerophosphate, bovine adrenal Cytosol™ extract, porcine brain, bovine bone, dl-methionine, oat flour, soybean lecithin, veal bone, mixed tocopherols (soy), carrot oil, and peanut (bran).

Other Ingredients: Gelatin, water, ascorbic acid, potassium para-aminobenzoate, niacinamide, colors, calcium stearate, riboflavin 5'-phosphate, vitamin A palmitate, and pyridoxal 5'-phosphate.

http://www.standardprocess.com/sp_catalog_product_detail.asp

http://www.standardprocess.com/lit/healthissueinfocards/FocusOnEyeHealthL1022.pdf

http://www.standardprocess.com/lit/tabsheets/iplex5100.pdf


Immuplex® - Introduced in 1984 and is a member of these product groups: Minerals, Vitamins

Immuplex combines vitamins A, B12, C, and E, and folic acid, and minerals such as zinc, copper, chromium, iron, and selenium. Immuplex contains bovine thymus, liver, and spleen tissue extracts - nutrients and glandulars well known for their important roles in immune system health and function. †

Content Product No.
40 Capsules 4935
150 Capsules 4960

Suggested Use: Two capsules per meal, or as directed.


Proprietary Blend: 565 MG
Bovine liver PMG™ extract, veal bone PMG™ extract, nutritional yeast, bovine spleen PMG™ extract, bovine thymus PMG™ extract, bovine thymus Cytosol™ extract, bovine liver, bovine spleen, and ovine spleen.

Other Ingredients: Gelatin, zinc liver chelate, ascorbic acid, iron liver chelate, water, chromium yeast, copper liver chelate, selenium yeast, mixed tocopherols (soy), colors, pyridoxine hydrochloride, calcium stearate, vitamin A palmitate, folic acid, and cyanocobalamin.


http://www.standardprocess.com/sp_catalog_product_detail.asp

Neuroplex® - Introduced in 1986 and is a member of these product groups: Minerals, Vitamins

The brain houses the primary center for regulating and coordinating bodily activities. The nervous system, along with the endocrine system, provides most of the control functions for the body. Neuroplex contains porcine brain tissue and bovine tissues from the hypothalamus, pituitary, and pineal glands. The pineal gland is the site of melatonin synthesis. †

Content Product No.
40 Capsules 5850

Suggested Use: Two capsules per day, or as directed.


Proprietary Blend: 696 MG
Tillandsia usneoides, bovine orchic Cytosol™ extract, bovine spleen, porcine brain PMG™ extract, defatted wheat (germ), bovine hypothalamus, bovine anterior pituitary, calcium lactate, bovine liver, potassium para-aminobenzoate, bovine pituitary PMG™ extract, porcine brain, and ascorbic acid.

Other Ingredients: Gelatin, zinc liver chelate, iron liver chelate, niacinamide, water, pyridoxine hydrochloride, calcium stearate, colors, copper liver chelate, cocarboxylase, and riboflavin.

http://www.standardprocess.com/sp_catalog_product_detail.asp


Neurotrophin PMG® - Introduced in 1953 and is a member of these product groups: Protomorphogen™ Extracts

The nervous system provides much of the control functions for the body. In general, the nervous system governs the rapid activities of the body, such as muscle contractions, constantly changing visceral events, and even the rates of secretion for some of the endocrine glands. Neurotrophin PMG contains Protomorphogen™ extracts which are uniquely derived nucleoprotein-mineral extracts that support cellular health. Porcine brain PMG™ extract helps maintain the nervous system in a good state of repair to support healthy brain function. †

Content Product No.
90 Tablets 5900

Suggested Use: One tablet per meal, or as directed.


Proprietary Blend: 205 MG
Porcine brain PMG™ extract and magnesium citrate.

Other Ingredients: Calcium lactate, cellulose, and calcium stearate.


http://www.standardprocess.com/sp_catalog_product_detail.asp

Contact Information

Address Standard Process Inc.
1200 West Royal Lee Drive
PO Box 904
Palmyra, WI 53156-0904
Phone 262-495-2122
Toll Free 800-848-5061 (USA)
e-mail info@standardprocess.com


Page last modified: Friday, June 10, 2005 2:40:12 PM

=========================
================
###

NOW COMPARE BOVINE INGREDIENTS FROM;


2003 - 2004 Product Catalog

Standard Process Inc.


NATURAL COCOA STANDARDBAR (mad cow candy bar)
(i will just list animal organs)
bovine adrenal, bovine liver, bovine spleen, ovine spleen, bovine kidney...

NATURAL PEANUT BUTTER STANDARDBAR

bovine adrenal, bovine liver, bovine spleen, ovine spleen, bovine kidney...

USF (MAD COW) OINTMENT (RUB A DUB DUB, KURU ETC) ;

bovine orhic glandular extract

UTROPHIN PMG

bovine uterus PMG

VASCULIN

bovine heart PMG extract, veal bone PMG extract, bovine liever, porcine
duodenum,
bovine adrenal Cytosol extract, bovine spleen, ovine spleen (some yummy
stuff)

IPLEX (neighbors mom died from CJD while taking these pills for years)

bovine eye PMG extract, veal bone PMG, bovine liver, porcine stomach,
bovine adrenal,
bovine kidney, bovine adrenal Cytosol extract, BOVINE BRAIN, bovine
bone, veal bone
meal

MYO-PLUS

bovine heart PMG, bovine liver, porcine stomach, bovine orchic extract,
bovine
spleen, ovine spleen, bovine adrenal Cytosol extract, BOVINE BRAIN

NEUROPLEX

bovine orchic Cytosol extract, bovine spleen, BOVINE BRAIN PMG EXTRACT,
BOVINE ANTERIOR PITUITARY, bovine liver, BOVINE PITUITARY PMG EXTRACT,
AND MORE BOVINE BRAIN... HOLY MAD COW IN A PILL !!!

NEUROTROPHIN PMG

BOVINE BRAIN PMG

NIACINAMIDE B6 VM

bovine liver, porcine stomach, bovine spleen ovine spleen,
BOVINE BRAIN

OCULOTROPHIN PMG
BOVINE EYE PMG

ORCHEX

bovine liver, bovine orchic Cytosol extract, porcine stomch,
bovine spleen, ovine spleen, BOVINE BRAIN

OSTARPLEX

veal bone PMG extract, veal bone PMG extract, bovine liver,
porcine stomach, bovine adrenal, bovine spleen, ovine spleen,
BOVINE BRAIN

PARAPLEX

bovine pancreas PMG extract, porcine duodenum, bovine adrenal PMG,
BOVINE PITUITARY PMG EXTRACT, bovine thyroid PMG extract

PITUITROPHIN PMG

RUMAPLEX

BOVINE BRAIN, veal bone PMG extract, bovine adrenal, bovine prostate
Cytosol extract, veal bone meal, bovine liver PMG extract, bovine spleen,
ovine spleen, bovine liver

SENAPLEX

bovine liver PMG extract, bovine adrenal, BOVNE BRAIN, veal bone meal,
bovine
kidney, bovine orchic extract, bovine spleen, ovine spleen ..........

THESE are just a few of MANY of just this ONE COMPANY...TSS

DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES ADVISORY COMMITTEE

Friday, January 19, 2001

Holiday Inn Bethesda Versailles I and II
8120 Wisconsin Avenue Bethesda, Maryland

2 PARTICIPANTS
Paul W. Brown, M.D., Chairperson
William Freas, Ph.D., Executive Secretary

VOTING MEMBERS
Ermias D. Belay, M.D. David C. Bolton, Ph.D. Donald S. Burke, M.D.
Dean O. Cliver, Ph.D.
Bruce M. Ewenstein, M.D., Ph.D. Peter G. Lurie, M.D. Pedro Piccardo,
M.D. Stanley B. Prusiner, M.D. Raymond P. Roos, M.D. Elizabeth S.
Williams, D.V.M., Ph.D.

VOTING CONSULTANTS
Linda A. Detwiler, D.V.M.
David Gaylor, Ph.D.

Paul R. McCurdy, M.D.
Kenrad E. Nelson, M.D.

NONVOTING CONSULTANT
Susan Leitman, M.D.

GUESTS
Richard Davey, M.D. Louis Katz, M.D.

snip...

page 501

253

1 DR. BOLTON: I have an additional question about
2 that. What is the assurance that additional locally sourced
3 tracheas are not added into that manufacturing process, thus
4 boosting the yield, if you will, but being returned to the
5 U.S. as being produced from U.S.-sourced raw material?
6 DR. McCURDY: Are there data to indicate how many
7 grams, or whatever, of infected brain are likely to infect
8 an organism, either animal or man, when taken orally?
9 DR. BROWN: If I am not mistaken, and I can be
10 corrected, I think a half a gram is enough in a cow, orally;
11 in other words, one good dietary-supplement pill.
12 DR. McCURDY: What I am driving at is the question
13 we are asked is really not do we wish to regulate these
14 things coming in. I think the statements about difficulties
15 in regulating things in the future or near future for new
16 regulations were probably accurate.
17 But I think that we could exhibit some quite
18 reasonable concern about blood donors who are taking dietary
19 supplements that contain a certain amount of unspecified-
20 origin brain, brain-related, brain and pituitary material.
21 If they have done this for more than a sniff or something
22 like that, then, perhaps, they should be deferred as blood
23 donors.
24 That is probably worse than spending six months in
25 the U.K.

1/19/01
3681t2.rtf(845) page 501


http://www.fda.gov/ohrms/dockets/ac/cber01.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


http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_07.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


TSS

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

BSE ALSO;


PrPSc distribution of a natural case of bovine spongiform encephalopathy


Yoshifumi Iwamaru, Yuka Okubo, Tamako Ikeda, Hiroko Hayashi, Mori- kazu Imamura, Takashi Yokoyama and Morikazu Shinagawa Priori Disease Research Center, National Institute of Animal Health, 3-1-5 Kannondai, Tsukuba 305-0856 Japan gan@affrc.go.jp


Abstract


Bovine spongiform encephalopathy (BSE) is a disease of cattle that causes progressive neurodegeneration of the central nervous system. Infectivity of BSE agent is accompanied with an abnormal isoform of prion protein (PrPSc). The specified risk materials (SRM) are tissues potentially carrying BSE infectivity. The following tissues are designated as SRM in Japan: the skull including the brain and eyes but excluding the glossa and the masse- ter muscle, the vertebral column excluding the vertebrae of the tail, spinal cord, distal illeum. For a risk management step, the use of SRM in both animal feed or human food has been prohibited. However, detailed PrPSc distribution remains obscure in BSE cattle and it has caused controversies
about definitions of SRM. Therefore we have examined PrPSc distribution in a BSE cattle by Western blotting to reassess definitions of SRM. The 11th BSE case in Japan was detected in fallen stock surveillance. The carcass was stocked in the refrigerator. For the detection of PrPSc, 200 mg of tissue samples were homogenized. Following collagenase treatment, samples were digested with proteinase K. After digestion, PrPSc was precipitated by sodium phosphotungstate (PTA). The pellets were subjected to Western blotting using the standard procedure. Anti-prion protein monoclonal antibody (mAb) T2 conjugated horseradish peroxidase was used for the detection of PrPSc. PrPSc was detected in brain, spinal cord, dorsal root ganglia, trigeminal ganglia, sublingual ganglion, retina. In addition, PrPSc was also detected in the peripheral nerves (sciatic nerve, tibial nerve, vagus nerve). Our results suggest that the currently accepted definitions of SRM in 9/13/2005


179
Page 10 of 17

BSE cattle may need to be reexamined.


T. Kitamoto (Ed.)
PRIONS
Food and Drug Safety

================

ALSO from the International Symposium of Prion Diseases held in Sendai, October 31, to November 2, 2004; Bovine spongiform encephalopathy (BSE) in Japan

snip...


"Furthermore, current studies into transmission of cases of BSE that are atypical or that develop in young cattle are expected to amplify the BSE prion" NO. Date conf. Farm Birth place and Date Age at diagnosis 8. 2003.10.6. Fukushima Tochigi 2001.10.13. 23 9. 2003.11.4. Hiroshima Hyogo 2002.1.13. 21 Test results # 8b, 9c cows Elisa Positive, WB Positive, IHC negative, histopathology negative b = atypical BSE case c = case of BSE in a young animal b,c, No PrPSc on IHC, and no spongiform change on histology International Symposium of Prion Diseases held in Sendai, October 31, to November 2, 2004. Tetsuyuki Kitamoto Professor and Chairman Department of Prion Research Tohoku University School of Medicine 2-1 SeiryoAoba-ku, Sendai 980-8575, JAPAN TEL +81-22-717-8147 FAX +81-22-717-8148 e-mail; kitamoto@mail.tains.tohoku.ac.jp Symposium Secretariat Kyomi Sasaki TEL +81-22-717-8233 FAX +81-22-717-7656 e-mail: kvomi-sasaki@mail.tains.tohoku.ac.ip ================================= 9/13/2005
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Page 11 of 17 From: TSS () Subject: Atypical Proteinase K-Resistant Prion Protein (PrPres) observed in an Apparently Healthy 23-Month-Old Holstein Steer Date: August 26, 2005 at 10:24 am PST Atypical Proteinase K-Resistant Prion Protein (PrPres) observed in an Apparently Healthy 23-Month-Old Holstein Steer Jpn. J. Infect. Dis., 56, 221-222, 2003 Laboratory and Epidemiology Communications Atypical Proteinase K-Resistant Prion Protein (PrPres) Observed in an Apparently Healthy 23-Month-Old Holstein Steer Yoshio Yamakawa*, KenÕichi Hagiwara, Kyoko Nohtomi, Yuko Nakamura, Masahiro Nishizima ,Yoshimi Higuchi1, Yuko Sato1, Tetsutaro Sata1 and the Expert Committee for BSE Diagnosis, Ministry of Health, Labour and Welfare of Japan2 Department of Biochemistry & Cell Biology and 1Department of Pathology, National Institute of Infectious Diseases, Tokyo 162-8640 and 2Miistry of Health, Labour and Welfare, Tokyo 100-8916 Communicated by Tetsutaro Sata (Accepted December 2, 2003) *Corresponding author: Mailing address: Department of Biochemistry and Cell Biology, National Institute of Infectious Diseases, Toyama 1-23-1, Shinjuku-ku, Tokyo 1628640,
Japan. Tel: +81-3-5285-1111, Fax: +81-3-5285-1157, E-mail: yamakawa@nih.go.jp


Since October 18, 2001, 'bovine spongiform encephalopathy (BSE) examination for all cattle slaughtered at abattoirs in the country' has been mandated in Japan by the Ministry of Health, Labour and Welfare (MHLW). 'Plateria' ELISA-kit (Bio-Rad Laboratories, Hercules, Calif., USA) is routinely used at abattoirs for detecting proteinase K (PK)-resistant prion protein (PrPSc) in the obex region. Samples positive according to the ELISA screening are further subjected to Western blot (WB) and histologic and immunohistochemical examination (IHC) at the National Institute of Infectious Diseases (NIID) or Obihiro University. If PrPSc is detected either by WB or by IHC, the cattle are diagnosed as BSE. The diagnosis is approved by the Expert Committee for BSE Diagnosis, MHLW. From October 18, 2001 to September 30, 2003, approximately 2.5 million cattle were screened at abattoirs. A hundred and ten specimens positive according to ELISA were subjected to WB/IHC. Seven showed positive by both WB and IHC, all exhibiting the typical electrophoretic profile of a high content of the di-glycosylated molecular form of PrPSc (1-3) and the distinctive granular deposition of PrPSc in neuronal cells and neuropil of the dorsal nucleus of vagus. An ELISA-positive specimen from a 23 month-old Holstein steer slaughtered on September 29, 2003, in Ibaraki Prefecture (Ibaraki case) was sent to the NIID for confirmation. The animal was reportedly healthy before slaughter. The OD titer in ELISA was slightly higher than the 'cut-off' level given by the manufacturer. The histology showed no spongiform changes and IHC revealed no signal of PrPSc accumulation typical for BSE. However, WB analysis of the homogenate that was prepared from the obex region and used for ELISA revealed a small amount of PrPSc with an electrophoretic profile different from that of typical BSE-associated PrPSc (1-3). The characteristics were (i) low content of the di-glycosylated molecular form of PrPSc, (ii) a faster migration of the non-glycosylated form of PrPSc on SDS-PAGE, and (iii) less resistance against PK digestion as compared with an authentic PrPSc specimen derived from an 83-month-old Holstein (Wakayama case) (Fig. 1). Table 1 summarizes the relative amounts of three distinctive glycoforms (di-, mono, non-glycosylated) of PrPSc calculated by densitometric analysis of the blot shown in Fig. 1. As 2.5 mg wet weight obex-equivalent homogenate of the Ibaraki case (Fig. 1, lane 4) gave slightly stronger band intensities of PrPSc than an 8 mg wet weight obex-equivqlent homogenate of a typical BSE-affected Wakayama case (Fig. 1, lane 2), the amount of PrPSc accumulated in the Ibaraki case was calculated to be 1/500 - 1/1000 of the Wakayama case. In the Ibaraki case, the PrPSc bands were not detectable in the homogenates of the proximal surrounding region of the obex. These findings were consistent with the low OD value in ELISA, i.e., 0.2 -0.3 for the Ibaraki case versus over 3.0 for the Wakayama case. The DNA sequence of the PrP coding region of the Ibaraki case was the same as that appearing in the database (GenBank accession number: AJ298878). More recently, we encountered another case that resembled the Ibaraki case. It was a 21-monthold
Holstein steer from Hiroshima Prefecture. WB showed typical BSE-specific PrPSc deposition though IHC did not detect positive signals of PrPSc (data not shown). Though the clinical onset of BSE is usually at around 5 years of age or later, a 20-month-old case showing the clinical signs has been reported (4). Variant forms of BSE similar to our cases, i.e., with atypical histopathological and/or biochemical phenotype, have been recently reported in Italy (5) and in France (6). Such variant BSE was not associated with mutations in the prion protein (PrP) coding region as in our case (5,6). The Ministry of Agriculture, Forestry and Fisheries of Japan (MAFF) announced a ban of feeding ruminants with meat bone meal (MBM) on September 18, 2001, and a complete ban was made on October 15 of the same year. According to the recent MAFF report, the previous seven cases of BSE in Japan were cattle born in 1995 - 1996 and possibly fed with cross-contaminated feed. However, the two cattle in this report were born after the complete ban. Whether contaminated MBM was implicated in the present cases remains to be investigated.

REFERENCES Collinge, J., Sidle, K. C. L., Meads, J., Ironside, J. and Hill, A. F. (1996): Molecular analysis of prion strain variation and the aetiology of 'new variant' CJD. Nature, 383, 685690.
Bruce, M. E., Will, R. G., Ironside, J. W., McConnell, I., Drummond, D., Suttie, A., McCardle, L., Chree, A., Hope, J., Birkett, C., Cousens, S., Fraser, H. and Bostock, C. J.
(1997): Transmissions to mice indicate that 'new variant' CJD is caused by the BSE agent. Nature, 389, 498-501.
Hill, A. F., Desbruslais, M., Joiner, S., Sidle, K. C. L., Gowland, I. and Collinge, J. (1997): The same prion strain causes vCJD and BSE. Nature, 389, 448-450.
Matravers, W., Bridgeman, J. and Smith, M.-F. (ed.)(2000): The BSE Inquiry. p. 37. vol. 16. The Stationery Office Ltd., Norwich, UK.
Casalone, C., Zanusso, G., Acutis, P. L., Crescio, M. I., Corona, C., Ferrari, S., Capobianco, R., Tagliavini, F., Monaco, S. and Caramelli, M. (2003): Identification of a novel
molecular and neuropathological BSE phenotype in Italy. International Conference on Prion Disease: from basic research to intervention concepts. Gasreig, Munhen,
October 8-10.
Bicaba, A. G., Laplanche, J. L., Ryder, S. and Baron, T. (2003): A molecular variant of bovine spongiform encephalopatie. International Conference on Prion Disease: from
basic research to intervention concepts. Gasreig, Munhen, October 8-10.
Asante, E. A., Linehan, J. M., Desbruslais, M., Joiner, S., Gowland, I., Wood, A. L., Welch, J., Hill, A. F., Lloyd, S. E., Wadsworth, J. D. F. and Collinge, J. (2002). BSE
prions propagate as either variant CJD-like or sporadic CJD-like prion strains in transgenic mice expressing human prion protein. EMBO J., 21, 6358-6366.
9/13/2005
Page 12 of 17 SEE SLIDES IN PDF FILE; http://www.nih.go.jp/JJID/56/221.pdf


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

AND CWD;


Prions in Skeletal Muscles of Deer with Chronic Wasting Disease Rachel C. Angers,1* Shawn R. Browning,1*† Tanya S. Seward,2 Christina J. Sigurdson,4‡ Michael W. Miller,5 Edward A. Hoover,4 Glenn C. Telling1,2,3§ 1Department of Microbiology, Immunology and Molecular Genetics, 2Sanders Brown Center on Aging, 3Department of Neurology, University of Kentucky, Lexington, KY 40536, USA. 4Department of Microbiology, Immunology and Pathology, Colorado State University, Fort Collins, CO 80523, USA. 5Colorado Division of Wildlife, Wildlife Research Center, Fort Collins, CO 80526, USA. *These authors contributed equally to this work. †Present address: Department of Infectology, Scripps Research Institute, 5353 Parkside Drive, RF-2, Jupiter, Florida, 33458, USA. ‡Present address: Institute of Neuropathology, University of Zurich, Schmelzbergstrasse 12, 8091 Zurich, Switzerland. §To whom correspondence should be addressed: E-mail: gtell2@uky.edu Prions are transmissible proteinaceous agents of mammals that cause fatal neurodegenerative diseases of the central nervous system (CNS). The presence of infectivity in skeletal muscle of experimentally infected mice raised the possibility that dietary exposure to prions might occur through meat consumption (1). Chronic wasting disease (CWD), an enigmatic and contagious prion disease of North American cervids, is of particular concern. The emergence of CWD in an increasingly wide geographic area and the interspecies transmission of bovine spongiform encephalopathy (BSE) to humans as variant Creutzfeldt Jakob disease (vCJD) have raised concerns about zoonotic transmission of CWD. To test whether skeletal muscle of diseased cervids.........SNIP....END

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.


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


The EMBO Journal, Vol. 19, No. 17 pp. 4425-4430, 2000
© European Molecular Biology Organization

Evidence of a molecular barrier limiting
susceptibility of humans, cattle and sheep to
chronic wasting disease

G.J. Raymond1, A. Bossers2, L.D. Raymond1, K.I. O?Rourke3,
L.E. McHolland4, P.K. Bryant III4, M.W. Miller5, E.S. Williams6, M.
Smits2
and B. Caughey1,7

1NIAID/NIH Rocky Mountain Laboratories, Hamilton, MT 59840,
3USDA/ARS/ADRU, Pullman, WA 99164-7030, 4USDA/ARS/ABADRL,
Laramie, WY 82071, 5Colorado Division of Wildlife, Wildlife Research
Center, Fort Collins, CO 80526-2097, 6Department of Veterinary Sciences,
University of Wyoming, Laramie, WY 82070, USA and 2ID-Lelystad,
Institute for Animal Science and Health, Lelystad, The Netherlands
7Corresponding author e-mail: bcaughey@nih.gov Received June 7, 2000;
revised July 3, 2000; accepted July 5, 2000.

Abstract

Chronic wasting disease (CWD) is a transmissible
spongiform encephalopathy (TSE) of deer and elk,
and little is known about its transmissibility to other
species. An important factor controlling
interspecies TSE susceptibility is prion protein (PrP)
homology between the source and recipient
species/genotypes. Furthermore, the efficiency with which
the protease-resistant PrP (PrP-res) of one
species induces the in vitro conversion of the normal PrP
(PrP-sen) of another species to the
protease-resistant state correlates with the cross-species
transmissibility of TSE agents. Here we
show that the CWD-associated PrP-res (PrPCWD) of cervids
readily induces the conversion of recombinant cervid PrP-sen
molecules to the protease-resistant state in accordance
with the known transmissibility of CWD between cervids. In contrast,
PrPCWD-induced conversions of human and bovine PrP-sen were
much less efficient, and conversion of ovine PrP-sen was
intermediate. These results demonstrate a barrier at the
molecular level that should limit the susceptibility of these non-cervid
species to CWD.

snip...

Clearly, it is premature to draw firm conclusions about CWD
passing naturally into humans, cattle and sheep, but the present
results suggest that CWD transmissions to humans would be as
limited by PrP incompatibility as transmissions of BSE or sheep
scrapie to humans. Although there is no evidence that sheep
scrapie has affected humans, it is likely that BSE has caused variant
CJD in 74 people (definite and probable variant CJD cases to
date according to the UK CJD Surveillance Unit). Given the
presumably large number of people exposed to BSE infectivity,
the susceptibility of humans may still be very low compared with
cattle, which would be consistent with the relatively inefficient
conversion of human PrP-sen by PrPBSE. Nonetheless, since
humans have apparently been infected by BSE, it would seem prudent
to take reasonable measures to limit exposure of humans
(as well as sheep and cattle) to CWD infectivity as has been
recommended for other animal TSEs.

snip...

http://www.emboj.org/current.shtml


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.fcgicmd=Retrieve&db=PubMed&list_uids=6997404&dopt=Abstract


Bovine Spongiform Encephalopathy (BSE, or

“Mad Cow Disease”): Current and Proposed

Safeguards

Updated October 13, 2005

Geoffrey S. Becker

Specialist in Agricultural Policy

Resources, Science and Industry Division

Sarah A. Lister

Specialist in Public Health and Epidemiology

Domestic Social Policy Division


SNIP...


http://www.ncseonline.org/NLE/CRSreports/05oct/RL32199.pdf

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


suppressed peer review of Harvard study October 31, 2002

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


UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE QUARTERLY ENFORCEMENT REPORT July 1, 2005 through September 30, 2005


snip...

Administrative Actions Pending or Taken at Small HACCP Plants [includes actions initiated in prior quarters]


snip...

DESERET MEAT 04852 M SPANISH FORK, UT
07/27/05
08/01/05
X
X
On 7/27/05, a suspension action concerning Bovine Spongiform Encephalopathy and Specified Risk Material was taken in accordance with 9 CFR Part 500.3.


snip...

Administrative Actions Pending or Taken at Small HACCP Plants [includes actions initiated in prior quarters]


snip...

MONTEBELLO MEAT PROCESSING, INC 19075 M19075 P MANATI, PR
08/01/05
08/18/05
X
X
X
09/26/05
On 8/1/05, an enforcement action concerning Bovine Spongiform Encephalopathy and Specified Risk Material was taken in accordance with 9 CFR Part 500.4.


snip...

Table 7. Administrative Actions: Very Small HACCP Plants (7/01/05 to 9/30/05)


snip...


A.J. CEKAK'S MEAT MARKET 09/01/05 09/20/05 On 9/1/05, an enforcement action

21562 M

concerning failure to meet regulatory ORD, NE requirements for Escherichia coli X X X Biotype 1 (E. coli) and Bovine Spongiform Encephalopathy/Specified Risk Material was taken in accordance with 9 CFR Part 500.4.


snip...

Administrative Actions Pending or Taken at Very Small HACCP Plants [includes actions initiated in prior quarters]


snip...

BROWN'S PROCESSING 13100 M13100 P ELSBERRY, MO
08/08/05
08/16/05
X
X
X
On 8/8/05, an enforcement action concerning Bovine Spongiform Encephalopathy and Specified Risk Material was taken in accordance with 9 CFR Part 500.4.


snip...

Administrative Actions Pending or Taken at Very Small HACCP Plants [includes actions initiated in prior quarters]


snip...


FIVE STAR PACK INC. 08725 M08725 P GOLDEN CITY, MO 09/01/05 09/09/05 X X On 9/1/05, an enforcement action concerning failure to meet regulatory requirements for Escherichia coli Biotype 1 (E. coli) and Bovine Spongiform Encephalopathy/Specified Risk Material was taken in accordance with 9 CFR Part 500.4.


snip...

Administrative Actions Pending or Taken at Very Small HACCP Plants [includes actions initiated in prior quarters]

snip...


H AND P MEATS 21352 M SOUTH PITTSBURG, TN 07/28/05 08/08/05 08/17/05 08/19/05 X X On 8/17/05, a suspension action concerning Bovine Spongiform Encephalopathy and Specified Risk Material was taken in accordance with 9 CFR Part 500.3.


snip...

HOPKINS PACKING COMPANY 11069 M BLACKFOOT, ID
07/28/05
08/01/05
X
X
On 7/28/05, a suspension action concerning Bovine Spongiform Encephalopathy and Specified Risk Material was taken in accordance with 9 CFR Part 500.3.


snip...

Administrative Actions Pending or Taken at Very Small HACCP Plants [includes actions initiated in prior quarters]

snip...


NORTHWEST PREMIUM MEATS LLC 11032 M11032 P NAMPA, ID 07/26/05 07/29/05 X X On 7/26/05, a suspension action concerning Bovine Spongiform Encephalopathy and Specified Risk Material was taken in accordance with 9 CFR Part 500.3.


snip...

PARADISE LOCKER MEATS 31865 M31865 P TRIMBLE, MO
09/21/05
X
X
On 9/21/05, an enforcement action concerning Bovine Spongiform Encephalopathy and Specified Risk Material was taken in accordance with 9 CFR Part 500.4.

PARAGON SPRAY DRYING, LLC 31792 M31792 P WAUKON, IA
09/06/05
09/12/05
X
X
X
On 9/6/05, an enforcement action concerning Bovine Spongiform Encephalopathy and Specified Risk Material was taken in accordance with 9 CFR Part 500.4.


snip...

Administrative Actions Pending or Taken at Very Small HACCP Plants [includes actions initiated in prior quarters]


snip...

RANDALL MEAT COMPANY 10669 M HOT SPRINGS, AR
07/01/05
07/28/05
X
X
X
On 7/1/05, an enforcement action concerning Bovine Spongiform Encephalopathy and Specified Risk Material was taken in accordance with 9 CFR Part 500.4.


snip...


Administrative Actions Pending or Taken at Very Small HACCP Plants [includes actions initiated in prior quarters]


snip...


08/04/05

08/19/05

On 8/4/05,

an enforcement action 01046 M01046 P concerning Bovine SpongiformKANSAS CITY, MO X X Encephalopathy and Specified Risk Material was taken in accordance with 9 CFR Part 500.4.


Administrative Actions Pending or Taken at Very Small HACCP Plants [includes actions initiated in prior quarters]


snip...


THE MEAT SHOP 08/18/05 09/06/05

09/09/05

On 9/6/05, a suspension action 31561 M concerning Bovine SpongiformBENSON, VT Encephalopathy and Specified Risk Material was taken in accordance with 9 CFR Part 500.3. XX X X X


THEURER'S QUALITY MEATS, 07/27/05 07/29/05

On 7/27/05, a suspension action INC concerning Bovine Spongiform31647 M31647 P Encephalopathy and Specified Risk X X

LEWISTON, UT Material was taken in accordance with 9 CFR Part 500.3.


TOOELE VALLEY MEATS 07/25/05 08/01/05

On 7/25/05, a suspension action 20594 M20594 Pconcerning Bovine Spongiform

GRANTSVILLE, UT X X Encephalopathy and Specified Risk Material was taken in accordance with 9 CFR Part 500.3.


snip...


52 pages


http://www.fsis.usda.gov/PDF/QER_Q4_FY2005.pdf


FOR IMMEDIATE RELEASE Contact: Kate Cyrul
Friday, February 3, 2006 (202) 225-3661


DeLauro Questions APHIS Officials over Retesting of Infected Cow

– IG Report finds agency officials overruled advice of field scientists –

WASHINGTON, D.C. – Congresswoman Rosa L. DeLauro (Conn.-3) today questioned the reasoning of officials at the Animal and Plant Health Inspection Service (APHIS) that overruled the advice of field scientists on the retesting of a domestic cow found to have the bovine spongiform encephalopathy (BSE) disease. After the USDA announced that the first case of BSE was identified in a native-born cow last June, officials at APHIS said no further testing of the animal was needed. The USDA’s inspector general, however, determined the testing used proved inconclusive results and said that a sample from the cow should be sent for further testing.

DeLauro is ranking member of the House Appropriations Agriculture subcommittee, which has jurisdiction and oversight responsibilities of USDA and FDA.

“I am concerned that the APHIS officials that reviewed these results seemed to make decisions based not on science, but on the economic ramifications a positive BSE finding in a domestic born animal could have on the U.S. economy,” said DeLauro. “When consumer safety is in question, APHIS should not be forced into additional testing of an inconclusive sample by its inspector general.

“While we are glad that this cow did not enter the human food supply, APHIS officials had a responsibility to further examine this sample that even our “gold standard” test proved inconclusive. By refusing to send samples for further testing, APHIS could have jeopardized consumer health and safety and put the industry at a disadvantage, drawing into question the safety of our beef.

“Today I am requesting that APHIS disclose which officials made this decision and further explain their reasoning for not voluntarily testing this inconclusive sample further.”

###

www.house.gov/delaurotss

http://www.house.gov/delauro/press/2006/February/APHIS_retesting_2_3_06.html


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


UNITED STATES DEPARTMENT OF AGRICULTURE OFFICE OF INSPECTOR GENERAL
Washington, D.C. 20250 January 25, 2006 REPLY TO ATTN OF: 50601-10-KC TO: W.
Ron DeHaven Administrator Animal and Plant Health Inspection Service Barbara
Masters Administrator Food Safety and Inspection Service ATTN: William J.
Hudnall Deputy Administrator Marketing Regulatory Program Business Services
William C. Smith Assistant Administrator Office of Program Evaluation,
Enforcement, and Review FROM: Robert W. Young /s/ Assistant Inspector
General for Audit SUBJECT: Animal and Plant Health Inspection Service -
Bovine Spongiform Encephalopathy (BSE) Surveillance Program - Phase II and
Food Safety and Inspection Service - Controls Over BSE Sampling, Specified
Risk Materials, and Advanced Meat Recovery Products - Phase III This report
presents the results of our audit of the enhanced BSE surveillance program
and controls over specified risk materials and advanced meat recovery
products. Your written response to the official draft report, dated January
20, 2006, is included as exhibit G with excerpts of the response and the
Office of Inspector General’s (OIG) position incorporated into the Findings
and Recommendations section of the report, where applicable. We accept the
management decisions for all recommendations. Please follow your agency’s
internal procedures in forwarding documentation for final action to the
Office of the Chief Financial Officer (OCFO). We are providing a separate
memorandum to the agencies and OCFO that provides specific information on
the actions to be completed to achieve final action. We appreciate your
timely response and the cooperation and assistance provided to our staff
during the audit USDA/OIG-A/50601-10-KC/ Page i

Executive Summary

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

Results in Brief This report evaluates elements of the interlocking
safeguards in place to protect United States (U.S.) beef from Bovine
Spongiform Encephalopathy, widely known as BSE or "mad cow disease." Since
1990, the U.S. Department of Agriculture (USDA), Animal and Plant Health
Inspection Service (APHIS), has led a multi-agency effort to monitor and
prevent BSE from entering the food supply. After discovering a BSE-positive
cow in December 2003, APHIS expanded its BSE surveillance program. To
further protect the food supply, USDA banned materials identified as being
at risk of carrying BSE (specified risk materials (SRM)), such as central
nervous system tissue. As part of this effort, USDA’s Food Safety and
Inspection Service (FSIS) required beef slaughter and processing facilities
to incorporate controls for handling such materials into their operational
plans. Onsite FSIS inspectors also inspect cattle for clinical signs in
order to prevent diseased animals from being slaughtered for human
consumption. To evaluate the effectiveness of the safeguards, we assessed
APHIS’ implementation of the expanded surveillance program, as well as FSIS’
controls to prevent banned SRMs from entering the food supply.

In June 2004, APHIS implemented its expanded surveillance program;
participation by industry in this surveillance program is voluntary. As of
May 2005, over 350,000 animals were sampled and tested for BSE. To date, two
animals tested positive for BSE; one tested positive after implementation of
the expanded surveillance program.

USDA made significant efforts to implement the expanded BSE surveillance
program. Much needed to be done in a short period of time to establish the
necessary processes, controls, infrastructure, and networks to assist in
this effort. In addition, extensive outreach and coordination was undertaken
with other Federal, State, and local entities, private industry, and
laboratory and veterinary networks. This report provides an assessment as to
the progress USDA made in expanding its surveillance effort and the
effectiveness of its controls and processes. This report also discusses the
limitations of its program and data in assessing the prevalence of BSE in
the U.S. herd.


snip...

40 ELISA test procedures require two additional (duplicate) tests if the
initial test is reactive, before final interpretation. If either of the
duplicate tests is reactive, the test is deemed inconclusive.

41 Protocol for BSE Contract Laboratories to Receive and Test Bovine Brain
Samples and Report Results for BSE Surveillance Standard Operating Procedure
(SOP), dated October 26, 2004.

42 The NVSL conducted an ELISA test on the original material tested at the
contract laboratory and on two new cuts from the sample tissue.

43 A visual examination of brain tissue by a microscope.

44 A localized pathological change in a bodily organ or tissue.

SNIP...


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


Page 1 of 17

From: Terry S. Singeltary Sr. [flounder9@verizon.net]

Sent: Thursday, September 08, 2005 6:17 PM

To: fsis.regulationscomments@fsis.usda.gov

Subject: [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirements

for the Disposition of Non-Ambulatory Disabled Cattle

Greetings FSIS,

I would kindly like to submit the following to [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and

Requirements for the Disposition of Non-Ambulatory Disabled Cattle

THE BSE/TSE SUB CLINICAL Non-Ambulatory Disabled Cattle

Broken bones and such may be the first signs of a sub clinical BSE/TSE Non-Ambulatory Disabled Cattle ;

SUB CLINICAL PRION INFECTION

MRC-43-00

Issued: Monday, 28 August 2000

NEW EVIDENCE OF SUB-CLINICAL PRION INFECTION: IMPORTANT RESEARCH

FINDINGS RELEVANT TO CJD AND BSE


Terry S. Singeltary Sr.

P.O. Box 42

Bacliff, Texas USA 77518

9/13/2005

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 BROWN
Date: 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

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


U.S. Scientist should be concerned with a CJD epidemic in the U.S., as well... 2 January 2000

http://bmj.bmjjournals.com/cgi/eletters/320/7226/8/b#EL1

Re: vCJD in the USA * BSE in U.S. 15 November 1999

http://bmj.bmjjournals.com/cgi/eletters/319/7220/1312/b#5406

ALL CJD * As at 3rd March 2006 (see increase in sCJD)

http://www.dh.gov.uk/assetRoot/04/13/11/73/04131173.pdf


USA


notice steady increase, but also notice in 2005, # 7 the 38 pendings cases through Oct. and #8 includes 53 type pending, 1 type unknown.

if you look at 2003 there were 3 type unknown.

wonder if they were the same or different than the unknown in 2005?

considering the soup that has been brewing over here in the USA for years via the rendering of BSE and atypical TSE in cattle, CWD, Scrapie, a few TME cases (not too much due to scent gland, but there were a few rendered, but all this, and you have one hell of a recipe for a new strains of TSE in humans. then who knows what 'friendly fire' cases would look like from this soup via secondary transmission via medical/surgical/dental arena. ...TSS


National Prion Disease Pathology Surveillance Center case exams...

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


Coexistence of multiple PrPSc types in individuals with

Creutzfeldt-Jakob disease


Magdalini Polymenidou, Katharina Stoeck, Markus
Glatzel, Martin Vey, Anne Bellon, and Adriano Aguzzi


Summary


Background The molecular typing of sporadic
Creutzfeldt-Jakob disease (CJD) is based on the size
and glycoform

ratio of protease-resistant prion protein (PrPSc), and
on PRNP haplotype. On digestion with proteinase K, type
1 and

type 2 PrPSc display unglycosylated core fragments of
21 kDa and 19 kDa, resulting from cleavage around amino

acids 82 and 97, respectively.

Methods We generated anti-PrP monoclonal antibodies to
epitopes immediately preceding the differential proteinase

K cleavage sites. These antibodies, which were
designated POM2 and POM12, recognise type 1, but not
type 2, PrPSc.

Findings We studied 114 brain samples from 70 patients
with sporadic CJD and three patients with variant CJD.

Every patient classified as CJD type 2, and all variant
CJD patients, showed POM2/POM12 reactivity in the

cerebellum and other PrPSc-rich brain areas, with a
typical PrPSc type 1 migration pattern.

Interpretation The regular coexistence of multiple
PrPSc types in patients with CJD casts doubts on the
validity of

electrophoretic PrPSc mobilities as surrogates for
prion strains, and questions the rational basis of
current CJD

classifications.


snip...


The above results set the existing CJD classifications

into debate and introduce interesting questions about

human CJD types. For example, do human prion types

exist in a dynamic equilibrium in the brains of affected

individuals? Do they coexist in most or even all CJD

cases? Is the biochemically identified PrPSc type simply

the dominant type, and not the only PrPSc species?


Published online October 31, 2005


http://neurology.thelancet.com

Full Text
Diagnosis and Reporting of Creutzfeldt-Jakob Disease
Singeltary, Sr et al.
JAMA.2001; 285: 733-734


http://jama.ama-assn.org/cgi/content/full/285/6/733?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=dignosing+and+reporting+creutzfeldt+jakob+disease&searchid=1048865596978_1528&stored_search=&FIRSTINDEX=0&journalcode=jama


Re: RE-Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob

disease in the United States


Email Terry S. Singeltary:


flounder@wt.net

I lost my mother to hvCJD (Heidenhain Variant CJD). I would like to

comment on the CDC's attempts to monitor the occurrence of emerging

forms of CJD. Asante, Collinge et al [1] have reported 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. However, CJD and all human TSEs are not reportable

nationally. CJD and all human TSEs must be made reportable in every

state and internationally. I hope that the CDC does not continue to

expect us to still believe that the 85%+ of all CJD cases which are

sporadic are all spontaneous, without route/source. We have many TSEs in

the USA in both animal and man. CWD in deer/elk is spreading rapidly and

CWD does transmit to mink, ferret, cattle, and squirrel monkey by

intracerebral inoculation. With the known incubation periods in other

TSEs, oral transmission studies of CWD may take much longer. Every

victim/family of CJD/TSEs should be asked about route and source of this

agent. To prolong this will only spread the agent and needlessly expose

others. In light of the findings of Asante and Collinge et al, there

should be drastic measures to safeguard the medical and surgical arena

from sporadic CJDs and all human TSEs. I only ponder how many sporadic

CJDs in the USA are type 2 PrPSc?


http://www.neurology.org/cgi/eletters/60/2/176#535

TSS




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