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BSE/Urine

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Mike

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Mad cow disease could spread through urine, Swiss study


Main Category: CJD/vCJD/Mad Cow Disease News


Researchers from the University Hospital of Zurich have found that prions can be spread through urine. Prions are proteins that cause mad cow disease, CJD and scrapie.

You can read about this study in the journal Science.

Lead researcher, Adriano Aguzzi, said that prions can be found in the urine of scrapie infected mice with kidney inflammation. Mice without kidney inflammation (infected with scrapie) had no prions in their urine.

Hence, they concluded that prions could be transmitted through urine.

Before this study, it was thought that the only way to infect an animal or human with BSE or CJD is through contaminated foods or feeds.

Perhaps we should monitor the urine, not just animal remains, say the researchers.

Written by: Christian Nordqvist
Editor: Medical News Today



Please send any medical news or health news press releases to: [email protected]
 
Mike, my discussions with Dr. Aguzzi led to us inviting him to participate in the validation of our test. He declined due to his workload. But he was provided with a copy of our Paper and found that we had already identified PrPsc in urine. He thought it was novel approach.

One aspect of urine-based PrPsc transfer - from one animal to another - that I have been studying is the manner in which bull elk, bull moose and male deer tend to sniff and lick the rear end of the female during their mating season. A natural species form of oral stimulations to the sexually active female that is designed to allow the male to mount and consumate the act of mating her. I have long thought that BSE and CWD could be transferred in this manner from one animal to another simply by the sharing of mucus traces and urine traces on the vulva or upper thigh areas of the female. I have observed hereford cattle - females - doing the exact same thing to each other as any amorous bull would to a cow and the idea of cross-contamination immediately came to mind. Whadda ya think on that issue Mike? Ron.
 
Being a Rancher ,bse-tester, I know you are correct on that statement.Sure sounds as the reason for the explosion in deer TSE's.That why I want a BSE URINE TEST for every class of animals.
 
Makes sense that it is a way that prions are spread in the animal world. Ron, the more I read and study, the more I get po'ed at the government agencies that deny these type tests. Seems as though they are trying to hide it instead of eradicate them.
 
Mike, I have sat and watched rutting elk cows literally bleeding from the rears as the bull licks her prior to mounting. He is subjected to licking vaginal discharge, blood and urine literally all at the same time. I have seen this with whitetail deer and Mule Deer. Moose tend to do the same also but the instances of CWD in Moose are apparently extremely rare with only a few cases reported world-wide. Deer on the other hand are running rampant with CWD in parts of the USA midwest and western Canada. Whitetail deer bucks will, like bull elk, mate with many many does in a very short time and therefore, the potential for spreading PrPsc is huge!! Bull Elk may breed with scores of cows in a matter of days. Governments like control and to openly state they have made mistakes is something you and I will never hear in our lifetime. So what is the answer. I am workng closely with a ranchers group here in Alberta who are going to open their own slaughter facilities very soon and they have agreed to use our test on every single animal. This will include cattle, sheep, goats, bison and whatever else goes through the plant. Even though the CFIA has not officially sanctioned the test (yet), they cannot stop it from being used. Various components of the market-place has come to this group and said that they would take everything that leaves the plant provided it has been tested. This group is also going to become involved in the validation of the test. Testing is the only way to go as it ensures the quality of the meat and meat by-products and this alone will generate a market acceptance beyond anything we have seen to date. Each animal tested will provide urine for the actual test, some brain tissue taken at post mortem and a slice of liver that will be archived for a specific time period in a bank of minus 80 freezers. We figure we can store many thousands of samples in a very small place for a period equal to the time the product leaves the plant and makes its way to the sales shelf, plus a cushion time of about a month or so at which time the stored samples will be destroyed. This allows for a tissue sample-bank to be maintained in the event some questions arise as to the condition of any particul animals. Along with each sample will be a data coded that will be used to trace the animal right back to the farm and all pertinant data relating to that individual animal. Once the market place becomes driven by the quality of the product and the BSE testing, then, and only then will the governments listen.

I was at a meeting here in Edmonton wherein a top Alberta Government advisor, openly stated that if Tyson and Cargill ever decided to use our test, then the Alberta Government and the Canadian Government would take a look at it, but not before as the total being tested per year throughout Canada would be capped at 30,000 animals - period! If that is not true government BS then I do not know what is? So who drives the government? Is it the packing industry or a handfull of advisors - or both? Personally, I think it a couple of twins called "bliss" and "ignorance!"
 
This problen could easily be soved with a $20.00 per head tax by packers to test every animal until we know the scope of BSE and know its routes of transmission. How much money did the taxpayers give to Tyson? $49 million would pay for a lot of tests.

I find it funny that the Alberta govt. openly said that the two main packers are basically dictating govt. policy in this issue. It tells you who is really running the country. Its not the people.

We have the same problem here in the USA.
 
bse-tester writes;


>>>Mike, my discussions with Dr. Aguzzi led to us inviting him to participate in the validation of our test. He declined due to his workload. But he was provided with a copy of our Paper and found that we had already identified PrPsc in urine. He thought it was novel approach. >>>

>>>One aspect of urine-based PrPsc transfer - from one animal to another - that I have been studying is the manner in which bull elk, bull moose and male deer tend to sniff and lick the rear end of the female during their mating season. A natural species form of oral stimulations to the sexually active female that is designed to allow the male to mount and consumate the act of mating her. I have long thought that BSE and CWD could be transferred in this manner from one animal to another simply by the sharing of mucus traces and urine traces on the vulva or upper thigh areas of the female. I have observed hereford cattle - females - doing the exact same thing to each other as any amorous bull would to a cow and the idea of cross-contamination immediately came to mind.<<<

>>>Mike, I have sat and watched rutting elk cows literally bleeding from the rears as the bull licks her prior to mounting. He is subjected to licking vaginal discharge, blood and urine literally all at the same time. I have seen this with whitetail deer and Mule Deer. Moose tend to do the same also but the instances of CWD in Moose are apparently extremely rare with only a few cases reported world-wide. Deer on the other hand are running rampant with CWD in parts of the USA midwest and western Canada. Whitetail deer bucks will, like bull elk, mate with many many does in a very short time and therefore, the potential for spreading PrPsc is huge!! <<<



bse-tester,

something else to consider, is the Mr. Macho type great white warrior in the woods, who smears 100% bull elk/deer urine all over themselves, as a scent to attract other big game, i was concerned about this years ago and tried to warn the hunters about this route of exposure, especially if one would have a cut, i.e. inoculation. really, makes no difference to me if they smear feces all over themselves if it make them feel better, but fact is both the urine and feces carry the TSE agent, and these products are still on the market. ...tss




DEPARTMENT OF HEALTH & HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND
DRUG ADMINISTRATION



April 9, 2001 WARNING LETTER



01-PHI-12 CERTIFIED MAIL RETURN RECEIPT REQUESTED



Brian J. Raymond, Owner Sandy Lake Mills 26 Mill Street P.O. Box 117
Sandy Lake, PA 16145 PHILADELPHIA DISTRICT



Tel: 215-597-4390



Dear Mr. Raymond:



Food and Drug Administration Investigator Gregory E. Beichner conducted
an inspection of your animal feed manufacturing operation, located in
Sandy Lake, Pennsylvania, on March 23, 2001, and determined that your
firm manufactures animal feeds including feeds containing prohibited
materials. The inspection found significant deviations from the
requirements set forth in Title 21, code of Federal Regulations, part
589.2000 - Animal Proteins Prohibited in Ruminant Feed. The regulation
is intended to prevent the establishment and amplification of Bovine
Spongiform Encephalopathy (BSE) . Such deviations cause products being
manufactured at this facility to be misbranded within the meaning of
Section 403(f), of the Federal Food, Drug, and Cosmetic Act (the Act).



Our investigation found failure to label your swine feed with the
required cautionary statement "Do Not Feed to cattle or other Ruminants"
The FDA suggests that the statement be distinguished by different
type-size or color or other means of highlighting the statement so that
it is easily noticed by a purchaser.



In addition, we note that you are using approximately 140 pounds of
cracked corn to flush your mixer used in the manufacture of animal feeds
containing prohibited material. This flushed material is fed to wild
game including deer, a ruminant animal. Feed material which may
potentially contain prohibited material should not be fed to ruminant
animals which may become part of the food chain.



The above is not intended to be an all-inclusive list of deviations from
the regulations. As a manufacturer of materials intended for animal feed
use, you are responsible for assuring that your overall operation and
the products you manufacture and distribute are in compliance with the
law. We have enclosed a copy of FDA's Small Entity Compliance Guide to
assist you with complying with the regulation... blah, blah, blah...


http://www.fda.gov/foi/warning_letters/g1115d.pdf


These results indicate that mule deer fawns develop detectable PrP res
after oral exposure to an inoculum containing CWD prions. In the
earliest post-exposure period, CWD PrPres was traced to the lymphoid
tissues draining the oral and intestinal mucosa (i.e. the
retropharyngeal lymph nodes, tonsil, ileal Peyer's patches and
ileocaecal lymph nodes), which probably received the highest initial
exposure to the inoculum. Hadlow et al. (1982) demonstrated scrapie
agent in the tonsil, retropharyngeal and mesenteric lymph nodes, ileum
and spleen in a 10-month-old naturally infected lamb by mouse bioassay.
Eight of nine sheep had infectivity in the retropharyngeal lymph node.
He concluded that the tissue distribution suggested primary infection
via the gastrointestinal tract. The tissue distribution of PrPres in the
early stages of infection in the fawns is strikingly similar to that
seen in naturally infected sheep with scrapie. These findings support
oral exposure as a natural route of CWD infection in deer and support
oral inoculation as a reasonable exposure route for experimental studies
of CWD.



snip...



http://vir.sgmjournals.org/cgi/content/full/80/10/2757



Science 14 October 2005:Vol. 310. no. 5746, pp. 324 - 326DOI: 10.1126/science.1118829

Reports

Coincident Scrapie Infection and Nephritis Lead to Urinary Prion Excretion

Harald Seeger,1* Mathias Heikenwalder,1* Nicolas Zeller,1 Jan Kranich,1 Petra Schwarz,1 Ariana Gaspert,2 Burkhardt Seifert,3 Gino Miele,1 Adriano Aguzzi1


Prion infectivity is typically restricted to the central nervous and lymphatic systems of infected hosts, but chronic inflammation can expand the distribution of prions. We tested whether chronic inflammatory kidney disorders would trigger excretion of prion infectivity into urine. Urinary proteins from scrapie-infected mice with lymphocytic nephritis induced scrapie upon inoculation into noninfected indicator mice. Prionuria was found in presymptomatic scrapie-infected and in sick mice, whereas neither prionuria nor urinary PrPSc was detectable in prion-infected wild-type or PrPC-overexpressing mice, or in nephritic mice inoculated with noninfectious brain. Thus, urine may provide a vector for horizontal prion transmission, and inflammation of excretory organs may influence prion spread.

snip...

How do prions enter the urine? Upon extrarenalreplication, blood-borne prions may beexcreted by a defective filtration apparatus.Alternatively, prions may be produced locallyand excreted during leukocyturia. Althoughprionemia occurs in many paradigms ofperipheral prion pathogenesis (15, 16), thelatter hypothesis appears more likely, becauseprionuria was invariably associated with localprion replication within kidneys.Urine from one CJD patient was reported toelicit prion disease in mice (17, 1, but not inprimates (19). Perhaps unrecognized nephriticconditions may underlie these discrepantobservations. Inflammation-associated prionuriamay also contribute to horizontal transmissionamong sheep, deer, and elk, whose high efficiencyof lateral transmission is not understood.References and Notes...snip...end


1 Institute of Neuropathology, University Hospital of Zürich, Schmelzbergstrasse 12, CH-8091 Zürich, Switzerland.2 Institute of Clinical Pathology, University Hospital of Zürich, Schmelzbergstrasse 12, CH-8091 Zürich, Switzerland.3 Institute of Biostatistics, University of Zürich, Sumatrastrasse 30, CH-8006 Zürich, Switzerland. * These authors contributed equally to this work. To whom correspondence should be addressed. E-mail: [email protected]

http://www.sciencemag.org/cgi/content/abstract/310/5746/324


http://www.biggamehunt.net/forums/viewtopic.php?t=7603


http://www.afia.org/Industry_News/forum.html?ShowMessage=1003


http://www.michiganwalleye.com/forum/printthread.php?t=23313


http://www.americansportsman.com/messageboard/hunting/smallgamehunting/deer/viewpost.asp?mb=deerhunting&post=642






what about those 'deer scents' of 100% urine', and the prion that is
found in urine, why not just pass the prion with the urine to other deer...


Mrs. Doe Pee Doe in Estrus Model FDE1 Mrs. Doe Pee's Doe in Estrus is
made from Estrus urine collected at the peak of the rut, blended with
Fresh Doe Urine for an extremely effective buck enticer. Use pre-rut
before the does come into heat. Use during full rut when bucks are most
active. Use during post-rut when bucks are still actively looking for
does. 1 oz.


http://www.gamecalls.net/huntingproducts/deerlures.html


ELK SCENT/SPRAY BOTTLE * Works anytime of the year * 100 % Cow
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Product Code WP-ESB $9.95


http://www.elkinc.com/Scent.asp


prions in urine?


[PDF] A URINE TEST FOR THE IN-VIVO DIAGNOSIS OF PRION DISEASES


http://www.sigov.si/vurs/PDF/diagnoastika-bse-urin.pdf


TSS

########### http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ############





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-------- Original Message -------- Subject: DOCKET-- 03D-0186 -- FDA Issues Draft Guidance on Use of Material From Deer and Elk in Animal Feed; Availability
Date: Fri, 16 May 2003 11:47:37 -0500
From: "Terry S. Singeltary Sr." <[email protected]>
To: [email protected]



Greetings FDA,i would kindly like to comment on;Docket 03D-0186FDA Issues Draft Guidance on Use of Material From Deer and Elk in Animal Feed; AvailabilitySeveral factors on this apparent voluntary proposal disturbs me greatly,please allow me to point them out;1. MY first point is the failure of the partial ruminant-to-ruminant feedban of 8/4/97. this partial and voluntary feed ban of some ruminantmaterials being fed back to cattle is terribly flawed. without the_total_ and _mandatory_ ban of all ruminant materials being fedback to ruminants including cattle, sheep, goat, deer, elk and mink,chickens, fish (all farmed animals for human/animal consumption),this half ass measure will fail terribly, as in the past decades... 2. WHAT about sub-clinical TSE in deer and elk? with the recentfindings of deer fawns being infected with CWD, how many couldpossibly be sub-clinically infected. until we have a rapid TSE test toassure us that all deer/elk are free of disease (clinical and sub-clinical),we must ban not only documented CWD infected deer/elk, but healthyones as well. it this is not done, they system will fail...3. WE must ban not only CNS (SRMs specified risk materials),but ALL tissues. recent new and old findings support infectivityin the rump or ass muscle. wether it be low or high, accumulationwill play a crucial role in TSEs.4. THERE are and have been for some time many TSEs in theUSA. TME in mink, Scrapie in Sheep and Goats, and unidentifiedTSE in USA cattle. all this has been proven, but the TSE in USAcattle has been totally ignored for decades. i will document thisdata below in my references.5. UNTIL we ban all ruminant by-products from being fed backto ALL ruminants, until we rapid TSE test (not only deer/elk) butcattle in sufficient numbers to find (1 million rapid TSE test inUSA cattle annually for 5 years), any partial measures such as theones proposed while ignoring sub-clinical TSEs and not rapid TSEtesting cattle, not closing down feed mills that continue to violate theFDA's BSE feed regulation (21 CFR 589.2000) and not makingfreely available those violations, will only continue to spread theseTSE mad cow agents in the USA. I am curious what we willcall a phenotype in a species that is mixed with who knowshow many strains of scrapie, who knows what strain or how manystrains of TSE in USA cattle, and the CWD in deer and elk (notelling how many strains there), but all of this has been renderedfor animal feeds in the USA for decades. it will get interesting oncesomeone starts looking in all species, including humans here in theUSA, but this has yet to happen... 6. IT is paramount that CJD be made reportable in every state(especially ''sporadic'' cjd), and that a CJD Questionnaire mustbe issued to every family of a victim of TSE. only checking deathcertificates will not be sufficient. this has been proven as well(see below HISTORY OF CJD -- CJD QUESTIONNAIRE)7. WE must learn from our past mistakes, not continue to makethe same mistakes... REFERENCES

snip...

Oral transmission and early lymphoid tropism of chronic wasting diseasePrPres in mule deer fawns (Odocoileus hemionus )Christina J. Sigurdson1, Elizabeth S. Williams2, Michael W. Miller3,Terry R. Spraker1,4, Katherine I. O'Rourke5 and Edward A. Hoover1Department of Pathology, College of Veterinary Medicine and BiomedicalSciences, Colorado State University, Fort Collins, CO 80523- 1671, USA1Department of Veterinary Sciences, University of Wyoming, 1174 SnowyRange Road, University of Wyoming, Laramie, WY 82070, USA 2Colorado Division of Wildlife, Wildlife Research Center, 317 WestProspect Road, Fort Collins, CO 80526-2097, USA3Colorado State University Veterinary Diagnostic Laboratory, 300 WestDrake Road, Fort Collins, CO 80523-1671, USA4Animal Disease Research Unit, Agricultural Research Service, USDepartment of Agriculture, 337 Bustad Hall, Washington State University,Pullman, WA 99164-7030, USA5Author for correspondence: Edward Hoover.Fax +1 970 491 0523. [email protected] deer fawns (Odocoileus hemionus) were inoculated orally with abrain homogenate prepared from mule deer with naturally occurringchronic wasting disease (CWD), a prion-induced transmissible spongiformencephalopathy. Fawns were necropsied and examined for PrP res, theabnormal prion protein isoform, at 10, 42, 53, 77, 78 and 80 dayspost-inoculation (p.i.) using an immunohistochemistry assay modified toenhance sensitivity. PrPres was detected in alimentary-tract-associatedlymphoid tissues (one or more of the following: retropharyngeal lymphnode, tonsil, Peyer's patch and ileocaecal lymph node) as early as 42days p.i. and in all fawns examined thereafter (53 to 80 days p.i.). NoPrPres staining was detected in lymphoid tissue of three control fawnsreceiving a control brain inoculum, nor was PrPres detectable in neuraltissue of any fawn. PrPres-specific staining was markedly enhanced bysequential tissue treatment with formic acid, proteinase K and hydratedautoclaving prior to immunohistochemical staining with monoclonalantibody F89/160.1.5. These results indicate that CWD PrP res can bedetected in lymphoid tissues draining the alimentary tract within a fewweeks after oral exposure to infectious prions and may reflect theinitial pathway of CWD infection in deer. The rapid infection of deerfawns following exposure by the most plausible natural route isconsistent with the efficient horizontal transmission of CWD in natureand enables accelerated studies of transmission and pathogenesis in thenative species.snip...These results indicate that mule deer fawns develop detectable PrP resafter oral exposure to an inoculum containing CWD prions. In theearliest post-exposure period, CWD PrPres was traced to the lymphoidtissues draining the oral and intestinal mucosa (i.e. theretropharyngeal lymph nodes, tonsil, ileal Peyer's patches andileocaecal lymph nodes), which probably received the highest initialexposure to the inoculum. Hadlow et al. (1982) demonstrated scrapieagent in the tonsil, retropharyngeal and mesenteric lymph nodes, ileumand spleen in a 10-month-old naturally infected lamb by mouse bioassay.Eight of nine sheep had infectivity in the retropharyngeal lymph node.He concluded that the tissue distribution suggested primary infectionvia the gastrointestinal tract. The tissue distribution of PrPres in theearly stages of infection in the fawns is strikingly similar to thatseen in naturally infected sheep with scrapie. These findings supportoral exposure as a natural route of CWD infection in deer and supportoral inoculation as a reasonable exposure route for experimental studiesof CWD.snip...http://vir.sgmjournals.org/cgi/content/full/80/10/2757===================================now, just what is in that deer feed? _ANIMAL PROTEIN_Subject: MAD DEER/ELK DISEASE AND POTENTIAL SOURCESDate: Sat, 25 May 2002 18:41:46 -0700From: "Terry S. Singeltary Sr."Reply-To: BSE-LTo: BSE-L8420-20.5% Antler DeveloperFor Deer and Game in the wildGuaranteed Analysis Ingredients / Products Feeding Directionssnip..._animal protein_http://www.surefed.com/deer.htmBODE'S GAME FEED SUPPLEMENT #400A RATION FOR DEERNET WEIGHT 50 POUNDS22.6 KG.snip..._animal protein_http://www.bodefeed.com/prod7.htmIngredientsGrain Products, Plant Protein Products, Processed Grain By-Products,Forage Products, Roughage Products 15%, Molasses Products,__Animal Protein Products__,Monocalcium Phosphate, Dicalcium Pyosphate, Salt,Calcium Carbonate, Vitamin A Acetate with D-activated Animal Sterol(source of Vitamin D3), Vitamin E Supplement, Vitamin B12 Supplement,Riboflavin Supplement, Niacin Supplement, Calcium Panothenate, CholineChloride, Folic Acid, Menadione Soduim Bisulfite Complex, PyridoxineHydorchloride, Thiamine Mononitrate, d-Biotin, Manganous Oxide, ZincOxide, Ferrous Carbonate, Calcium Iodate, Cobalt Carbonate, DriedSacchoromyces Berevisiae Fermentation Solubles, Cellulose gum,Artificial Flavors added.http://www.bodefeed.com/prod6.htm===================================MORE ANIMAL PROTEIN PRODUCTS FOR DEERBode's #1 Game PelletsA RATION FOR DEERF3153GUARANTEED ANALYSISCrude Protein (Min) 16%Crude Fat (Min) 2.0%Crude Fiber (Max) 19%Calcium (Ca) (Min) 1.25%Calcium (Ca) (Max) 1.75%Phosphorus (P) (Min) 1.0%Salt (Min) .30%Salt (Max) .70%IngredientsGrain Products, Plant Protein Products, Processed Grain By-Products,Forage Products, Roughage Products, 15% Molasses Products,__Animal Protein Products__,Monocalcium Phosphate, Dicalcium Phosphate, Salt,Calcium Carbonate, Vitamin A Acetate with D-activated Animal Sterol(source of Vitamin D3) Vitamin E Supplement, Vitamin B12 Supplement,Roboflavin Supplement, Niacin Supplement, Calcium Pantothenate, CholineChloride, Folic Acid, Menadione Sodium Bisulfite Complex, PyridoxineHydrochloride, Thiamine Mononitrate, e - Biotin, Manganous Oxide, ZincOxide, Ferrous Carbonate, Calcium Iodate, Cobalt Carbonate, DriedSaccharyomyces Cerevisiae Fermentation Solubles, Cellulose gum,Artificial Flavors added.FEEDING DIRECTIONSFeed as Creep Feed with Normal Diethttp://www.bodefeed.com/prod8.htmINGREDIENTSGrain Products, Roughage Products (not more than 35%), Processed GrainBy-Products, Plant Protein Products, Forage Products,__Animal Protein Products__,L-Lysine, Calcium Carbonate, Salt, Monocalcium/DicalciumPhosphate, Yeast Culture, Magnesium Oxide, Cobalt Carbonate, BasicCopper Chloride, Manganese Sulfate, Manganous Oxide, Sodium Selenite,Zinc Sulfate, Zinc Oxide, Sodium Selenite, Potassium Iodide,Ethylenediamine Dihydriodide, Vitamin E Supplement, Vitamin ASupplement, Vitamin D3 Supplement, Mineral Oil, Mold Inhibitor, CalciumLignin Sulfonate, Vitamin B12 Supplement, Menadione Sodium BisulfiteComplex, Calcium Pantothenate, Riboflavin, Niacin, Biotin, Folic Acid,Pyridoxine Hydrochloride, Mineral Oil, Chromium TripicolinateDIRECTIONS FOR USEDeer Builder Pellets is designed to be fed to deer under rangeconditions or deer that require higher levels of protein. Feed to deerduring gestation, fawning, lactation, antler growth and pre-rut, allphases which require a higher level of nutrition. Provide adequateamounts of good quality roughage and fresh water at all times.http://www.profilenutrition.com/Products/Specialty/deer_builder_pellets.html===================================================DEPARTMENT OF HEALTH & HUMAN SERVICESPUBLIC HEALTH SERVICEFOOD AND DRUG ADMINISTRATIONApril 9, 2001 WARNING LETTER01-PHI-12CERTIFIED MAILRETURN RECEIPT REQUESTEDBrian J. Raymond, OwnerSandy Lake Mills26 Mill StreetP.O. Box 117Sandy Lake, PA 16145PHILADELPHIA DISTRICTTel: 215-597-4390Dear Mr. Raymond:Food and Drug Administration Investigator Gregory E. Beichner conductedan inspection of your animal feed manufacturing operation, located inSandy Lake, Pennsylvania, on March 23,2001, and determined that your firm manufactures animal feeds includingfeeds containing prohibited materials. The inspection found significantdeviations from the requirements set forth inTitle 21, code of Federal Regulations, part 589.2000 - Animal ProteinsProhibited in Ruminant Feed. The regulation is intended to prevent theestablishment and amplification of Bovine Spongiform Encephalopathy(BSE) . Such deviations cause products being manufactured at thisfacility to be misbranded within the meaning of Section 403(f), of theFederal Food, Drug, and CosmeticAct (the Act).Our investigation found failure to label yourswine feed with the required cautionary statement "Do Not Feed to cattleor other Ruminants" The FDA suggests that the statement bedistinguishedby different type-size or color or other means of highlighting thestatement so that it is easily noticed by a purchaser.In addition, we note that you are using approximately 140 pounds ofcracked corn to flush your mixer used in the manufacture of animalfeeds containing prohibited material. Thisflushed material is fed to wild game including deer, a ruminant animal.Feed material which may potentially contain prohibited material shouldnot be fed to ruminant animals which may become part of the food chain.The above is not intended to be an all-inclusive list of deviations fromthe regulations. As a manufacturer of materials intended for animalfeed use, you are responsible for assuring that your overall operationand the products you manufacture and distribute are in compliance withthe law. We have enclosed a copy of FDA's Small Entity Compliance Guideto assist you with complying with the regulation... blah, blah, blah...http://www.fda.gov/foi/warning_letters/g1115d.pdf==================================

tss
 
Encephalopathies Rapid Test

NewsRx.com, February 23, 2006



Genesis Bioventures, Inc., (GBI) (GBIW) announced that the U.S. Patent & Trademark Office has issued a notice of allowance for the Rapid Prion-Detection Assay developed by Prion Developmental Laboratories (PDL), a portfolio company of GBI.

The patent for the Rapid Prion-Detection Assay protects this method of testing for all transmissible spongiform encephalopathies (TSEs) in animals and humans. PDL has already received approval for its chronic wasting disease assay and is currently focusing on rapid diagnostic tests for mad cow disease and other animal TSEs.

Dr. Robert Petersen, CEO of PDL, commented, "This is a pivotal patent for the industry and for consumers as it clears the path for producers and meat packers in the United States to economically test all beef produced for consumption and to ensure that exported beef is free from the infectious agent that causes mad cow disease. We believe this is a critically important development that can have substantial economic benefit to the $98 billion United States beef industry by enabling regimens to test every animal before the animal is processed and shipped to food stores or exported to foreign nations."

Dr. Richard Rubenstein, PDL's chief scientific officer, added, "This is a milestone event for PDL and our entire team. This patent further validates the science behind our effort to supply a simple, cost-effective solution to protect the human food supply against mad cow disease and other forms of TSEs. We believe our technology has the potential to become a world leader in numerous commercialized tests for TSEs in the near future."

PDL is a biotechnology company that researches, develops, and produces advanced diagnostic and food safety monitoring tests for human and animal diseases caused by prions. Genesis Bioventures, Inc., has a significant investment in PDL.

Genesis Bioventures, Inc., is a biomedical-development corporation focusing on the development and marketing of diagnostics and therapeutics in oncology and neurodegenerative diseases. This article was prepared by Biotech Week editors from staff and other reports. Copyright 2006, Biotech Week via NewsRx.com.
 
The Best part ;Dr. Robert Petersen, CEO of PDL, commented, "This is a pivotal patent for the industry and for consumers as it clears the path for producers and meat packers in the United States to economically test all beef produced for consumption and to ensure that exported beef is free from the infectious agent that causes mad cow disease. We believe this is a critically important development that can have substantial economic benefit to the $98 billion United States beef industry by enabling regimens to test every animal before the animal is processed and shipped to food stores or exported to foreign nations."
 

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