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

Accepted - Volume 7

Comment Record
Commentor Mr. Terry Singeltary Date/Time 2003-03-13 17:24:13
Organization CJD WATCH
Category Individual

Comments for FDA General
1. General Comments [Docket No. 96N-0417] Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements Greetings FDA, i would kindly like to make a submission to the above docket number 96N-0417. my name is Terry S. Singeltary Sr. and on 12-14-97 my mother died from Heidenhain Variant Creutzfeldt Jakob disease. i have researched this daily ever since. EXACTLY one year to the day previously on 12-14-96, my neighbor _also_ lost his mother to sCJD. both of these cases confirmed. in the case with my _neighbors_ mother, she had been taking a nutritional supplement called IPLEX; IPLEX; (listing only potentially TSE tainted tissues) vacuum dried bovine BRAIN, bone meal, bovine EYE, veal bone, bovine liver powder, bovine adrenal, vacuum dried bovine kidney, and vacuum dried porcine stomach. [please note, Dr. Gibbs and NIH/CDC took the particular batch of pills (what was left) from my neighbors mother house and did testing on them that came back negative. at the same time, he told me the testing techniques to date may not have picked up any low level infectivity, and she had been taking these type supplements for years, so it could have been another batch, especially if the accumulation theory plays in as opposed to the single dose theory. my opinion they are both likely.] also this is another example of 100s of these type products on the market; Immuplex Ingredients; Bovine Liver PMG Extract, zinc-iron-copper liver chelate, bovine liver powder, veal bone PMG Extract, ascorbic acid, nutritional yeast, bovine spleen PMG Extract, high selenium yeast, vaccum dried bovine and ovine spleen, bovine thymus PMG Extract, bovine thymus Cytosol Extract, mixed tocopherois, high chromium yeast, pyridoxal 5-phosphate, vitamin A esters, calcium lactate, folic asid and cyanocabalamin. Two capsules supple 165 mg Bovine Liver PMG Extract, 45 mg Bovine spleen PMG Extract, 40 mg Vacuum Dried Bovine and Ovine Spleen, 35 mg. Bovine Thymus PMG Extract and 35 mg Bovine Thymus Cytosol Extract. METABOLIFE; Bovine Complex; Glandular system; Ovaries, Prostate, Scrotum and Adrenal (usda cattle) [big deal...tss] Subject: Metabolife Date: Mon, 7, Dec 1998 14:21:35 -0800 From: Rand Smith To: '' Dear Sir, We are looking at reformulation. I agree that slow virus diseases present a problem in some areas of the world. Our product uses healthy USDA inspected cattle for the glandular extract. If you have any links to more information on this subject I would like to examine them. Thank you for your interest and concern. Dr. Smith ============================ i brought this to attention of the Federal Gov. many times; TSE Advisory Comm. 2001 and again in 1998; EPA Comment Number: 550-2 Received: October 26, 1998 Subject: DOCKET # opp-00550 FEDERAL FOOD AND SAFETY PLAN!!! also cjd supplement warning letters somewhere here; and remember, the MILLIONS of cattle infected with BSE in the U.K. were eating nothing more than a 'nutritional supplement'. about pea size. what did Paul Brown say about this previously; i bring your attention to (page 500) Dr. Paul Brown statements; 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. 254 1 DR. BROWN: That is exactly right. I think that 2 is why the discussion has apparently been on things that are 3 not directly related to these questions because, in order to 4 think about deferrals for blood donors who are taking 5 dietary supplements with things like bovine brain in them, 6 it is very important that we know that those products are 7 safe. 8 I think we have heard enough to suggest that they 9 may not be. 10 DR. McCURDY: There is one other item that needs 11 to be considered and that is what proportion of blood donors 12 are doing this; that is, how many blood donors would you 13 lose, and I don't know what the demographics--there is 14 fairly good information on the demography of blood donors. 15 I have no idea what the demography of people who take these 16 supplements is. Maybe they are old men like me and aren't 17 going to be blood donors anymore. 18 DR. BROWN: The wording of the question is not as 19 demanding as the wording of other deferral questions; that 20 is, the question here is consider recommending. We are 21 not even recommending at this point. We are saying to the 22 FDA, please think about this. It is worth thinking about. 23 DR. DETWILER: One point about brain from Europe, 24 and Jean Philippe is still here, those are considered 25 specified risk material and it is not correct to be 255 1 incinerated; correct? Or destroyed? Brain and spinal cord 2 and other high-risk tissues in Europe? 3 DR. NORTON: In tomorrow morning's British Medical 4 Journal, which has appeared on-line today, there is an 5 article called U.S. Takes Precautions against BSE. One 6 paragraph says, Even though the U.S. and U.K. governments 7 ban the practice of feeding cattle products to cows, in the 8 early 1990s, some U.K. renderers continued to manufacture 9 and ship contaminated meat and bonemeal around the world. 10 British export statistics show that thirty-seven tons of 11 meal made from offal was sent to the United States in 1997, 12 well after the U.S. government banned imports of such risky 13 meat. The ultimate use of these imports has not been 14 identified. 15 That will appear tomorrow morning. 16 DR. DETWILER: That actually was in The New York 17 Times. That is a direct quote out of The New York Times 18 article. We called the reporter on that. That statement, 19 the thirty-seven tons, was taken out of the U.S. 20 Geographical BSE Risk Assessment. What they didn't put in 21 there, in the statement, was the remainder of the GBR is at 22 that time, the big labeling for that category in the U.K., 23 because it was illegal for them to ship it to us from their 24 own regs. It is illegal for us to get that. 25 We did go and try and trace that so that wasn't [FULL TEXT ABOUT 600 PAGES] 3681t2.rtf more bad news, they are finding that even as small as .1 gram to be lethal per W.H.O. Rickets et al; BSE/TSE .1 GRAM LETHAL NEW STUDY SAYS via W.H.O. Dr Maura Ricketts [BBC radio 4 FARM news] (audio realplayer LISTEN) with all due respect, Dr. Detwiler needs to stop trying to protect the industry so hard, and start trying to protect the consumer a little better. her consistant refusal to rapid test USA cattle in sufficient numbers to find TSEs will be the downfall of this industry. we have imported tons of MBM/Greaves from the UK. we have imported many other potentially tainted TSE products from many known BSE/TSE Countries over the years. but truthfully, i am more concerned with a homegrown TSE. really it does not matter whether it's a imported strain or a homegrown strain, bottom line, it has been ignored far too long here in the USA, and they are all 100% lethal... Subject: Re: exports from the U.K. of it's MBM to U.S.??? From: Date: Tue, 8 Feb 2000 14:03:16 +0000 To: (Receipt Notification Requested) (Non Receipt Notification Requested) Terry Meat and bonemeal is not specifically classified for overseas trade purposes. The nearest equivalent is listed as flours and meals of meat or offals (including tankage), unfit for human consumption; greaves. UK exports of this to the US are listed below: Country Tonnes 1980 1981 12 1982 1983 1984 10 1985 2 1986 1987 1988 1989 20 1990 Data for exports between 1975 and 1979 are not readily available. These can be obtained (at a charge) from data retailers appointed by HM Customs and Excise: BTSL (Tel: 01372 463121) or Abacus (01245 252222). Best wishes Simon Pearsall Overseas trade statistics Stats (C&F)C ====================================== we have many many TSEs in the USA. plus the USA still refuses to make CJD reportable Nationally, and still refuses to issue a CJD Questionnaire to all the victims and there families seeking to find route and source of agent, whether it be from nutritional supplement or from vaccines or from food route or surgical/medical industry or from any of the many potential routes in the USA, we will never know without investigating these victims and there habits. we _must_ have a CJD Questionnaire, and we must make CJD reportable Nationally. FORGET ABOUT THE NV/V CJD ONLY THEORY! all this i have well documented here; In Reply to: Docket No. 01-068-1 Risk Reduction Strategies for Potential BSE Pathways Involving Downer Cattle and Dead Stock of Cattle and Other Species [TSS SUBMISSION] January 21, 2003 Cattlemen to finalize BSE research contracts (WHAT'S THE RUSH, LET'S WAIT ANOTHER 30 YEARS) - TSS 1/17/03 (0) we have imported many potentially tainted TSE products to the USA, via multiple routes. Besides the 44 tons of the MBM/Greaves we imported from the UK during the BSE crisis, there are the live cattle, beef products, and what about BSE/scrapie in sheep and the sheep/goats we have imported? i have that documented as well; NOT FOR PUBLICATION COMMERCIAL IN CONFIDENCE COMMITTEE ON SAFETY OF MEDICINES 1989/1990 snip... Comment- It is known that British Bone Meal has been exported to the Netherlands and the USA. It is possible that it may have been used to compound animal feed stuffs, which may have been used for cattle. The use of ruminant protein has _NOT_ been banned in the USA. The Company have not addressed the issue of ensuring that source cattle have not been fed ruminant protein, and that feeding practices are recorded and certified... snip... sadly, we import many potentially tainted TSE products. here is some organs and other glands. with the infamous NSCS non species coding system. this comes in very handy for importing potentially tainted TSE products; U.S. Imports for Consumption: December 1998 and 1998 Year-to-Date Subheading 300110: GLANDS AND OTHER ORGANS, DRIED, WHETHER OR NOT POWDERED List of (6-digit) Subheadings in this (2-digit) Chapter Next (6-Digit) Subheading ... Descending ... Ascending Latest Monthly Data Switch from U.S. Imports to U.S. Exports About These Trade Data Tables 3001.10.0010: LIVER,DRIED,WHETHER OR NOT DRIED U.S. Imports for Consumption: December 1998 and 1998 Year-to-Date (Customs Value, in Thousands of Dollars) (Units of Quantity: Kilograms) <--- Dec 1998 ---> <--- 1998 YTD ---> Country Quantity Value Quantity Value ================================================================= WORLD TOTAL . . . . . . . 13,000 61 240,500 941 Argentina . . . . . . . . 12,000 41 236,000 865 Denmark . . . . . . . . . 1,000 20 4,500 76 3001.10.0050: OTHER GLANDS AND OTHER ORGANS, DRIED, WHETHER OR NOT POWDERED U.S. Imports for Consumption: December 1998 and 1998 Year-to-Date (Customs Value, in Thousands of Dollars) (Units of Quantity: Kilograms) <--- Dec 1998 ---> <--- 1998 YTD ---> Country Quantity Value Quantity Value ================================================================= WORLD TOTAL . . . . . . . 26,320 1,148 235,208 11,249 Argentina . . . . . . . . 11,850 146 93,655 1,168 Australia . . . . . . . . --- --- 8 7 Canada . . . . . . . . . --- --- 17,850 30 China (mainland) . . . . 3,500 331 10,117 998 Denmark . . . . . . . . . 10,970 671 90,589 6,918 France . . . . . . . . . --- --- 7,703 741 Hungary . . . . . . . . . --- --- 117 65 Ireland . . . . . . . . . --- --- 4 14 Israel . . . . . . . . . --- --- 5 7 Italy . . . . . . . . . . --- --- 8,530 194 Netherlands . . . . . . . --- --- 17 5 New Zealand . . . . . . . --- --- 336 19 Spain . . . . . . . . . . --- --- 5,994 817 Sweden . . . . . . . . . --- --- 1 10 Switzerland . . . . . . . --- --- 278 253 United Kingdom . . . . . --- --- 4 5 Bovine anmls bnlss ex prcssd frozen/U.S. Imports for Consumption 1997 year to date (custom value, in thousands of dollars) (units of quantity: kilograms) United Kingdom 37,122 kilograms, 43 thousand dollars Netherlands 56,260 kilograms, 413 thousand dollars Canada 18,141,481 kilograms, 23,914 million dollars snip... another fine example; snip... In fact, the salesman now tells us he doesn’t sell the machines anymore. But the quest for youth goes beyond facial creams and exotic contraptions, anti-agers are also ingesting some pretty wild-sounding dietary supplements. “Live proteins from sheep and pig from France, processed,” says a representative. Life-Cell Technologies touts the benefits of supplements that contain processed pig and sheep organs. “I have a lot of body builders and professional athletes that use these products because they strengthen and stimulate the different glands and organs,” says one woman. The idea, she implied, often is that ingesting ground up animal organs will strengthen human organs or even cure thyroid and adrenal diseases. “To my knowledge you can’t just take pulverzied organs and feed them to somebody and think they’re not going to have thyroid disease anymore or hypo-adrenalism,” says Dr. Wexler. It would be kind of a medical miracle, wouldn’t it? “It would be amazing, truly amazing,” says Dr. Wexler. “Dateline” attended another anti-aging conference and expo in Chicago — this time with our cameras in plain view. Remember the exhibitor selling processed pig and sheep organs? We pressed her for scientific documentation. We asked, what is the science behind the idea? The woman tells us, “You would have to go on the Internet and get information, scientific studies.” But this is her company, isn’t it? “Yes it is,” she says. “And if you don’t mind, I don’t want to be interviewed. I don’t.” snip... url is dead now; company data; LifeCell™ Dietary Supplements are derived from the finest organic ovine and porcine sources. They are offered as 31 individual organs and many combinations, or complexes, of live proteins, which are processed under the most sterile conditions by highly qualified and experienced biologists. Each animal used in obtaining live protein supplements is tested for purity by the Agriculture Department of France. They are given a numbered document prior to processing, and then, from each one hundred bottles, three are taken at random to be checked for quality and sterility by the Institut Alfred Fournier, a government laboratory. about that non species coding system, BSE Countries, cross contaminations etc., this can be explained better here. another leaky situation in our 'sealed borders'; # Docket No: 02-088-1 RE-Agricultural Bioterrorism Protection Act of 2002; [TSS SUBMISSION ON POTENTIAL FOR BSE/TSE & FMD 'SUITCASE BOMBS'] - TSS 1/27/03 (0) now, for those that will be saying there is no documented proof of transmission of CJD via the nutritional supplements, i ask, who is looking and who has done transmission studies? absent of evidence is not evidence of absence, no matter how hard they try to make this case. so, lets look at some logistics. logistically speaking, there has never been transmission studies of any sort with TSE transmission to man. HOWEVER, we must not over look this; 1: J Infect Dis 1980 Aug;142(2):205-8 Oral transmission of kuru, Creutzfeldt-Jakob disease, and scrapie to nonhuman primates. Gibbs CJ Jr, Amyx HL, Bacote A, Masters CL, Gajdusek DC. Kuru and Creutzfeldt-Jakob disease of humans and scrapie disease of sheep and goats were transmitted to squirrel monkeys (Saimiri sciureus) that were exposed to the infectious agents only by their nonforced consumption of known infectious tissues. The asymptomatic incubation period in the one monkey exposed to the virus of kuru was 36 months; that in the two monkeys exposed to the virus of Creutzfeldt-Jakob disease was 23 and 27 months, respectively; and that in the two monkeys exposed to the virus of scrapie was 25 and 32 months, respectively. Careful physical examination of the buccal cavities of all of the monkeys failed to reveal signs or oral lesions. One additional monkey similarly exposed to kuru has remained asymptomatic during the 39 months that it has been under observation. PMID: 6997404 just what about those supposedly USDA ''TISSUE DONOR HERDS''? do they really exist? this was taken from my notes of the infamous Jan. 9, 2001 50 STATE EMERGENCY BSE CONFERENCE CALL which i did participate in as an _uninvited_ guest; Subject: BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001 Date: Tue, 9 Jan 2001 16:49:00 -0800 From: Terry S. Singeltary Sr. Reply-To: Bovine Spongiform Encephalopathy To: ######### Bovine Spongiform Encephalopathy ######### Greetings List Members, I was lucky enough to sit in on this BSE conference call today and even managed to ask a question. that is when the trouble started. I submitted a version of my notes to Sandra Blakeslee of the New York Times, whom seemed very upset, and rightly so. They tell me it is a closed meeting and they will release whatever information they deem fit. Rather infuriating. and i would have been doing just fine, until i asked my question. i was surprised my time to ask a question so quick. (understand, these are taken from my notes for now. the spelling of names and such could be off.) [host Richard Barns] and now a question from Terry S. Singeltary of CJD Watch. [TSS] yes, thank you, U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds? [no answer, you could hear in the back ground, mumbling and 'we can't. have him ask the question again.] [host Richard] could you repeat the question? [TSS] U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds? [not sure whom ask this] what group are you with? [TSS] CJD Watch, my Mom died from hvCJD and we are tracking CJD world-wide. [not sure who is speaking] could you please disconnect Mr. Singeltary [TSS] you are not going to answer my question? [not sure whom speaking] NO from this point, i was still connected, got to listen and tape the whole conference. at one point someone came on, a woman, and ask again; [unknown woman] what group are you with? [TSS] CJD Watch and my Mom died from hvCJD we are trying to tract down CJD and other human TSE's world wide. i was invited to sit in on this from someone inside the USDA/APHIS and that is why i am here. do you intend on banning me from this conference now? at this point the conference was turned back up, and i got to finish listening. They never answered or even addressed my one question, or even addressed the issue. BUT, i will try and give you a run-down for now, of the conference. snip... full text; VERY IMPORTANT NEW DATA ON SPORADIC CJD AND BSE !!! the fact that with the new findings from Collinge et al, that BSE transmission to the 129-methionine genotype can lead to an alternate phenotype which is indistinguishable from type 2 PrPSc, the commonest sporadic CJD, i only ponder how many of the sporadic CJDs in the USA are tied to this alternate phenotype? these new findings are very serious, and should have a major impact on the way sporadic CJDs are now treated as opposed to the vCJD that was thought to be the only TSE tied to ingesting beef, in the medical/surgical arena AND NUTRITIONAL SUPPLEMENTS; Subject: re-BSE prions propagate as either variant CJD-like or sporadic CJD Date: Thu, 28 Nov 2002 10:23:43 -0000 From: Asante, Emmanuel A To: '' Dear Terry, I have been asked by Professor Collinge to respond to your request. I am a Senior Scientist in the MRC Prion Unit and the lead author on the paper. I have attached a pdf copy of the paper for your attention. Thank you for your interest in the paper. In respect of your first question, the simple answer is, yes. As you will find in the paper, we have managed to associate the alternate phenotype to type 2 PrPSc, the commonest sporadic CJD. It is too early to be able to claim any further sub-classification in respect of Heidenhain variant CJD or Vicky Rimmer's version. It will take further studies, which are on-going, to establish if there are sub-types to our initial finding which we are now reporting. The main point of the paper is that, as well as leading to the expected new variant CJD phenotype, BSE transmission to the 129-methionine genotype can lead to an alternate phenotype which is indistinguishable from type 2 PrPSc. I hope reading the paper will enlighten you more on the subject. If I can be of any further assistance please to not hesitate to ask. Best wishes. Emmanuel Asante <> ____________________________________ Dr. Emmanuel A Asante MRC Prion Unit & Neurogenetics Dept. Imperial College School of Medicine (St. Mary's) Norfolk Place, LONDON W2 1PG Tel: +44 (0)20 7594 3794 Fax: +44 (0)20 7706 3272 PLEASE SEE FULL TEXT OF THIS ARTICLE; other documented TSEs in the USA; ROUND TABLE ON BSE -- WASHINGTON -- 27-28 JUNE 1989 snip... The summary does tend to give a particular slant to the epidemiology of BSE which is not totally sound. It is a possibility that the agent of BSE may be in the cattle population in a number of countries already apart from the USA and that clinical cases are occurring on rare occasions. It is also important to off the possibility of the relationship between BSE and certain low-temperature rendering systems. For that reason a number of other countries apart from the USA and France are at risk and, in particular, the Netherlands, Denmark, Germany and Belgium. For these reasons it would be wise to move to an international ban on the feeding of ruminant protein to ruminants. Clearly the summary also needs to refer to the incidence of BSE in the UK and not solely to Great Britain. No doubt this has been tidied up in your comments on the summary conclusions. It is a pity that more of the comments put forward by Dr. Kimberlin have not been included in the summary since his views on page 13 are succinct and valuable... snip... Is there a Scrapie-like disease in cattle ? IN CONFIDENCE R.F. MARSH snip... re-mink rancher 'Wisconsin' dead stock feeder using >95% downer or dead dairy and a few horses... Part of the Proceedings of an International Roundtable on Bovine Spongiform Encephalopathy, Bethesda, Maryland, USA, June 27-28, 1989. The possibility of infection with BSE in the United States, as defined by studies on the disease in Great Britain, is judged to be low on the basis of the following: (1) meat and bonemeals imported into the United States from Great Britain between 1980 and 1988 were used mainly in poultry, not ruminant feed; (2) the Scrapie Eradication Program had reduced the prevalence of scrapie in the United States compared with that in Great Britain; and (3) little, if any, rendered animal products are used for protein supplements in cattle feed in the United States. However, there is some evidence that there may already be a scrapie-like disease in cattle in the United States. This evidence comes from epidemiologic studies on an incident of transmissible mink encephalopathy (TME) in Stetsonville, Wis, in 1985. This mink farmer used no commercially available animal by-product mixtures in his feed, but instead slaughtered all animals going into the mink diet, which included mostly (>95%) downer dairy cows, a few horses, but never sheep. To examine the possibility that cattle may have been the source of this incident of TME, two 6-week-old Holstein bull calves were inoculated intracerebrally with mink brain from the affected farm. The bulls developed neurologic disease 18 and 19 months after inoculation. Both brains had spongiform degeneration at necropsy and both were transmissible back to mink by either intracerebral (incubation period of 4 months) or oral (incubation period of 7 months) inoculation Whereas TME has been thought to be caused by feeding scrapie-infected sheep to mink, this theory has no conclusive evidence. Experimental oral inoculation of mink with several different sources of sheep scrapie has never been successful, and an incubation period of less than 12 months has never (sic) produced by intracerebral inoculation. Transmissible mink encephalopathy can develop naturally by infection with incubation periods of less than 12 months. There is reason to believe that scrapie has not been transmitted in the United States from sheep to cattle by rendered protein concentrates as it was in Great Britain. However, some circumstantial evidence exists that cattle may be a source of some TME infections. It is recommended that we increase our surveillance for a BSE-like disease in American cattle by encouraging state diagnostic laboratories to formalin-fix specimens of midbrain and brain stem from bovine brains submitted for rabies testing. If results of these tests are negative, these fixed tissues can then be examined for evidence of spongiform degeneration of the gray matter. -Comments on bovine spongiform encephalopathy J Am Vet Med Assoc 197 (4): (1990) Letter to the Editor, Journal of the American Veterinary Medical Association, August 15, 1990 In my article, Bovine spongiform encephalopathy in the United States (JAVMA, May 15, 1990, p 1677), I stated that little, if any, rendered animal products are used for protein supplements in cattle feed in the United States. I have since learned that this is incorrect, because of the recent trend of using less assimilated by-pass proteins in cattle feed. A large amount of meat-and-bone meal is being fed to American cattle, and this change in feeding practice has greatly increased the risk of bovine spongiform encephalopathy (BSE) developing in the United States. Epidemiologic studies on BSE in Great Britain have indicated that the disease originated in cattle by exposure to the heat-resistant transmissible agent in compounded feed containing rendered animal protein. The most likely source of infection was assumed to be meat-and-bone meal prepared from scrapie-infected sheep, but it is also possible that a heretofore unrecognized scrapie-like infection of cattle could have been spread in the same manner. Because of concern for the possible development of BSE in the United States, the American rendering industry discontinued the processing of fallen and sick sheep last December. In my opinion, this was a prudent policy, but one that will not prevent the possible transmission of BSE from cattle to cattle. As emphasized in my article, there is some evidence that BSE-like infection may already exist in American cattle. The current practice of feeding meat-and-bone meal to cattle solidifies the most important means to perpetuate and amplify the disease cycle. In Great Britain, BSE has produced a great economic and emotional burden. We must take all reasonable measures to prevent BSE from developing in the United States. Therefore, the practice of using animal protein in cattle feed should be discontinued as soon as possible. Waiting until the first case of BSE is diagnosed in the United States will certainly be closing the barn door after the horse is gone. With a disease having a 3- to 6-year incubation period, thousands of animals would be exposed before we recognize the problem and, if that happens, we would be in for a decade of turmoil. R. F. Marsh, DVM, PhD Madison, Wis ============= Subject: Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease in the United States [FULL TEXT] Date: Sat, 22 Feb 2003 10:40:26 -0600 From: Terry S. Singeltary Sr. Reply-To: Bovine Spongiform Encephalopathy To: ######## Bovine Spongiform Encephalopathy ######### Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease in the United States [FULL TEXT] TSS ########### ############ OR GO HERE AND URLS ARE HIGHLIGHTED WITH REFERENCE ACCESS;;article=507 PAGE 25 Transmission Studies Mule deer transmissions of CWD were by intracerebral inoculation and compared with natural cases resulted in a more rapidly progressive clinical disease with repeated episodes of synocopy ending in coma. One control animal became affected, it is believed through contamination of inoculam (?saline). Further CWD transmissions were carried out by Dick Marsh into ferret, mink and squirrel monkey. Transmission occurred in _all_ of these species with the shortest incubation period in the ferret. FULL TEXT OF GOA REPORT BELOW (takes a while to load) 2. Mad Cow Disease: Improvements in the Animal Feed Ban and Other Regulatory Areas Would Strengthen U.S. Prevention Efforts. GAO-02-183, January 25. ============================================= Subject: SCRAPIE 'USA' ANNUAL REPORT (105 newly infected flocks 2002) & CWD IN USA Date: Tue, 10 Dec 2002 08:17:17 -0600 From: Terry S. Singeltary Sr. To: Date: Mon, 9 Dec 2002 21:21:10 -0600 Reply-To: Bovine Spongiform Encephalopathy Sender: Bovine Spongiform Encephalopathy From: Terry S. Singeltary Sr. Subject: SCRAPIE 'USA' ANNUAL REPORT (105 newly infected flocks 2002) & CWD IN USA As of September 30, 2002, there were 45 scrapie infected and source flocks (figure 3). There were 105 newly infected flocks, reported in FY2002 (figure 4). In addition, 379 scrapie cases were confirmed and reported by the National Veterinary Services Laboratories (NVSL) in FY 2002 (figure 5) and (figure 6). Five cases of scrapie in goats were reported in FY 2002 (figure 7), the last of which was confirmed in August 2002. New infected and source flocks numbers and the number of these flocks released in FY 2002 are depicted in chart 4. One hundred (100) flocks which is 67 percent of the scrapie infected and source flocks present in FY 2002 were released or put on clean-up plans in FY2002. Slaughter Surveillance Slaughter Surveillance is currently in Phase II which is intended to determine the prevalence of scrapie in the US culled sheep population. Through September 2002 samples from 3,269 sheep were submitted to NVSL for testing. Samples from a total of 6,795 sheep have been submitted since the beginning of Phase II on April 1, 2002. Surveillance regions are depicted in (figure 8). Scrapie Testing During FY 2002 11,751 animals have been tested for scrapie which includes: 2,711 regular necropsy cases, 1,343 third eyelid biopsies for the test validation project, 546 third eyelid biopsies for the regulatory program, and approximately 7,151 animals for Phase I & II of SOSS (chart 5). Laboratory testing has been taking 10 - 11 days on average with a range of 3 - 34 days. Ear Tag Orders During FY 2002 9.9 million plastic and 6.0 million metal tags were distributed by APHIS (chart 6). NEW SCRAPIE INFECTED AND SOURCE FLOCKS DISTRIBUTION OF CHRONIC WASTING DISEASE THROUGHOUT THE STATES (as of Oct. 2002) CWD USA surveillance PLEASE do not make the same mistake with Scrapie and CWD, about statements made of NO transmission to man, as they did in the early days with BSE. Scrapie and CWD will transmit to man as easily or as difficulty (depending whom you have watch die from CJD) as BSE will to humans. an interesting finding from a French Iatrogentic CJD case, that was identical to a scrapie strain; NEW SCIENTIST MAGAZINE 4/02/01 NEW SCIENTIST EDITORIAL PAGE 3 MAD SHEEP DISEASE? IF THERE is one categorical pronouncement you can safely make about prion diseases like BSE or CJD, it is that one should not make categorical pronouncements. British beef is safe and there is no BSE in Germany come to mind. Now there are two more: scrapie is safe, and people don't catch sporadic CJD. Scrapie is the most widespread prion disease, infecting untold numbers of sheep worldwide. Sporadic CJD is the old-fashioned pre-BSE kind that is supposed to happen spontaneously in unlucky people. But a surprise observation in France suggests some sCJD cases--though by no means all--may be linked to scrapie after all (see p 4). For years, British authorities asserted that BSE was harmless because it was a form of scrapie. In fact, the only evidence scrapie is safe is some broad-brush epidemiology, good as far as it goes but unable to reveal occasional risks for some people from some sheep. Alarm bells should have rung in 1980 when researchers gave monkeys scrapie by feeding them infected brains. But that research, like so much other work on prion diseases, was never followed up. We still have little idea what BSE does in pigs and chickens. The Queniborough vCJD outbreak (see p 5) would be easier to understand if we knew how much brain we must eat to be infected. As for scrapie, it shouldn't take a chance finding to tell us that there may be dangerous sheep out there. Suspect symptoms What if you can catch old-fashioned CJD by eating meat from a sheep infected with scrapie? Exclusive from New Scientist magazine Four years ago, Terry Singeltary watched his mother die horribly from a degenerative brain disease................. full text url follows By Debora MacKenzie Suspect Symptoms if url dead, go here for 'SUSPECT SYMPTOMS' you can access article here also; Then follow up with PNAS studies from which new scientist article written from; Published online before print March 20, 2001 Proc. Natl. Acad. Sci. USA, 10.1073/pnas.041490898 Abstract of this Article Reprint (PDF) Version of this Article Similar articles found in: PNAS Online PubMed PubMed Citation Search Medline for articles by: Lasmézas, C. I. || Deslys, J.-P. Alert me when: new articles cite this article Download to Citation Manager Neurobiology Adaptation of the bovine spongiform encephalopathy agent to primates and comparison with Creutzfeldt- Jakob disease: Implications for human health Corinne Ida Lasmézas*, [dagger] , Jean-Guy Fournier*, Virginie Nouvel*, Hermann Boe*, Domíníque Marcé*, François Lamoury*, Nicolas Kopp [Dagger ] , Jean-Jacques Hauw§, James Ironside¶, Moira Bruce [||] , Dominique Dormont*, and Jean-Philippe Deslys* * 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; [Dagger ] Hôpital Neurologique Pierre Wertheimer, 59, Boulevard Pinel, 69003 Lyon, France; § Laboratoire de Neuropathologie, Hôpital de la Salpêtrière, 83, Boulevard de l'Hôpital, 75013 Paris, France; ¶ Creutzfeldt-Jakob Disease Surveillance Unit, Western General Hospital, Crewe Road, Edinburgh EH4 2XU, United Kingdom; and [||] Institute for Animal Health, Neuropathogenesis Unit, West Mains Road, Edinburgh EH9 3JF, United Kingdom Edited by D. Carleton Gajdusek, Centre National de la Recherche Scientifique, Gif-sur-Yvette, France, and approved December 7, 2000 (received for review October 16, 2000) Abstract There is substantial scientific evidence to support the notion that bovine spongiform encephalopathy (BSE) has contaminated human beings, causing variant Creutzfeldt-Jakob disease (vCJD). This disease has raised concerns about the possibility of an iatrogenic secondary transmission to humans, because the biological properties of the primate-adapted BSE agent are unknown. We show that (i) BSE can be transmitted from primate to primate by intravenous route in 25 months, and (ii) an iatrogenic transmission of vCJD to humans could be readily recognized pathologically, whether it occurs by the central or peripheral route. Strain typing in mice demonstrates that the BSE agent adapts to macaques in the same way as it does to humans and confirms that the BSE agent is responsible for vCJD not only in the United Kingdom but also in France. The agent responsible for French iatrogenic growth hormone-linked CJD taken as a control is very different from vCJD but is similar to that found in one case of sporadic CJD and one sheep scrapie isolate. These data will be key in identifying the origin of human cases of prion disease, including accidental vCJD transmission, and could provide bases for vCJD risk assessment. Introduction The recognition of a variant of the human transmissible spongiform encephalopathy (TSE) Creutzfeldt-Jakob Disease (vCJD) in the U.K. in 1996 raised the major concern that it would correspond to human infection with the agent responsible for bovine spongiform encephalopathy (BSE; ref. 1). Transmission of BSE to macaques provided the first experimental evidence as it produced a disease close to vCJD in humans (2). Strain typing in inbred mice (consisting of measuring the incubation period and establishing lesion profiles corresponding to the strain-specific distribution of brain vacuolation) allows reliable identification of TSE strains (3). This method, together with biochemical methods, has revealed a single phenotype for the agents of BSE and the British cases of vCJD (4-6). Mice expressing only the bovine prion protein (PrP) were highly susceptible to vCJD and BSE, which induced the same disease (7). Thus, it is now well established that BSE has caused vCJD, probably by alimentary contamination. In this respect, the finding of abnormal PrP labeling in the gastrointestinal tract and lymphatic tissues of orally BSE-contaminated lemurs shows that the BSE agent can infect primates by the oral route (8). About 1 million contaminated cattle may have entered the human food chain, and the future number of vCJD cases could range from 63 to 136,000 depending on the incubation period of BSE in humans (9). Unlike sporadic CJD (sCJD) and iatrogenic CJD (iCJD) linked to the administration of contaminated growth hormone extracted from human hypophyses, in vCJD, the infectious agent seems to be widely distributed in lymphoid organs, as pathological PrP (PrPres) can be detected in tonsils, lymph nodes, spleen, and appendix even in the preclinical phase of the disease (10, 11). This raises a public health issue with regard to the risk of iatrogenic transmission of vCJD through surgical instruments, grafts, blood transfusion, or parenteral administration of biological products of human origin. However, this risk is difficult to assess, because it largely depends on factors such as the virulence of the BSE agent adapted to primates and the efficiency of secondary transmission to humans by a peripheral route such as the i.v. one. A further issue is whether vCJD accidentally acquired from humans would be recognized. The latter poses the question of a phenotypic variation of the BSE agent after successive transmissions in humans: does it retain its strain characteristics, and does it induce a pathology similar to that observed in the previous host? A 9-year history of transmission of BSE to primates and mice enables us today to clarify a number of these important points. Although BSE has mainly affected the U.K., two definite cases and one probable case of vCJD have now been reported in France in people who have never resided in the U.K. (12, 13). We strain-typed the first of these cases to establish its origin. Strain typing in C57BL/6 mice of BSE, French, and British vCJD was compared with that of BSE passaged in nonhuman primates, thus allowing us to study the effect of serial passages in primates. Comparisons were also made with French cases of sCJD and iCJD and two strains of scrapie (one of French and one of U.S. origin). Our findings provide experimental demonstration that the same agent, namely that responsible for the cattle disease BSE, has caused vCJD both in France and in the U.K., in line with biochemical data and with the fact that, until 1996, about 10% of the beef consumed in France was imported from the U.K. We found that the BSE agent in nonhuman primates is similar to that causing vCJD in humans and tends to evolve rapidly toward a primate-adapted variant. Furthermore, we showed that the strain responsible for iCJD is closely related to that of one patient with sCJD, and, more unexpectedly, that these agents were similar to the French scrapie strain studied (but different from the U.S. scrapie strain). This finding requires a cautious interpretation for several reasons, not least because of the inevitably limited number of TSE strains that can be studied by such a cumbersome method as strain typing. Nonetheless, it also prompts reconsideration of the possibility that, in some instances, sheep and human TSEs can share a common origin. snip... STATEMENT OF DR HELEN GRANT MD FRCP ISSUED 13/05/1999 BSE INQUIRY CWD to CJD in humans (why not?), as easy as BSE/Scrapie; 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: 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... Scrapie to Humans? no process the supplement industry has that i am aware of will kill this agent considering it survives ashing to 600 degrees celsius, the industry is dangerously unregulated, so in my opinion, all desicated animal organs should be banned from these products (we must ban all SRMs specified risk materials and MRMs mechanically recovered meats and not only for animals, but for man as well) in any form. the nutritional supplement industry as a whole, should be regulated the same way that all pharmaceutical products are _suppose_ to be regulated. and let us hope it is better than what they have done with the vaccine industry and TSEs; TIP740203/l 0424 CONFIDENTIAL TWA LITTLE minute COMMERCIAL IN CONFIDENCE NOT FOR PUBLICATION NON-LICENSED HUMAN TISSUE DEVICES WERE NOT COMMERCIALLY AVAILABLE snip... I was quite prepared to believe in unofficial pituitary hormones, also in the 1970's, whether as described by Dr. Little, or in other circumstances, for animal use. snip... The fact that there were jars of pituitaries (or extract) around on shelves is attested by the still potent 1943 pituitaries, described in Stockell Hartree et al. (J/RF/17/291) which had come from the lab. at Mill Hill. Having taken the trouble to collect them, they were not lightly thrown out... more on the 1968 medicine act, they forgot to follow Draft cover letter to product licence holders (considered by Human and Vet Medicines including deer) (It was noted with concern that hormone extracts could be manufactured by a veterinary surgeon for administration to animals under his care without any Medicines Act Control.) TWA LITTLE STATEMENT 331 Nutritional Supplements ======================= After 10 years of the same old warning letter going out to the nutritional supplements industry about sourcing there products from ''BSE free'' herds (no such thing, especially in the USA), and the same flagrant ignoring of these facts by the industry, the FDA MUST TAKE ACTION NOW! INGREDIENTS should be accurately labeled, with _all_ ingredients. HEALTH CLAIMS should be backed up with scientific data, backed up and verified by the same Governing body that verifies pharmacueticals, and under the same stringent safety regulations. ALL animal/human organs and tissues BANNED in these products! INCLUDING From the Summer 2002, Venison & Velvet newsletter of the elk and deer farming industry in Wisconsin. (In July over 7,000 pounds of antlers were collected from state game farms for pooled use in human nutritional supplements) from the State ''GAME FARMS'' !!! CWD transmits to primates, cattle, mink, ferrits, sheep, deer. CWD transmission studies have never been done on man. i am no Doctor, i have no PhD, and am President of nothing. i make no money and seek no monitary gains from my research. i simply seek the truth. i want to know who is responsible for my mothers death, and many others are seeking the same answers... Moms death from hvCJD 'MOMS AUTOPSY REPORT' SOMETHING TO CHEW ON BMJ BMJ Diagnosis and Reporting of Creutzfeldt-Jakob Disease T. S. Singeltary, Sr; D. E. Kraemer; R. V. Gibbons, R. C. Holman, E. D. Belay, L. B. Schonberger 1 million rapid TSE test in USA cattle annually for 5 years if you want the truth. you continue to flounder around, the agent continues to spread, people continue to die, the industry continues laughing all the way to the bank $$$ MAD COW BOARD TSS BSE NEWS CJD WATCH CJD Watch message board # FSIS--MEETING ON INTERNATIONAL MEAT AND POULTRY FOOD SAFETY MARCH 27, 2003 [TSS SUBMISSION] - TSS 3/10/03 (0) Transmissible Spongiform Encephalopathy Advisory Committee February 20, 2003 - TSS 3/08/03 Part 1 Transmissible Spongiform Encephalopathy Advisory Committee February 20, 2003 - TSS 3/08/03 Part 2 Transmissible Spongiform Encephalopathy Advisory Committee February 20, 2003 - TSS 3/09/03 (0) Part 3 Cattlemen to finalize BSE research contracts (WHAT'S THE RUSH, LET'S WAIT ANOTHER 30 YEARS) - TSS 1/17/03 (0) #Docket No. 01-068-1 Risk Reduction Strategies for Potential BSE Pathways Involving Downer Cattle and Dead Stock of Cattle and Other Species - TSS 1/21/03 (2) In Reply to: Docket No. 01-068-1 Risk Reduction Strategies for Potential BSE Pathways Involving Downer Cattle and Dead Stock of Cattle and Other Species [TSS SUBMISSION] January 21, 2003 Re: Docket No. 01-068-1 -- (200,000 USA DOWNERS ANNUALLY) TSS 1/21/03 Re: Docket No. 02N-0273 Substances Prohibited From Use In Animal Food Or Feed; # Docket No: 02-088-1 RE-Agricultural Bioterrorism Protection Act of 2002; [TSS SUBMISSION ON POTENTIAL FOR BSE/TSE & FMD 'SUITCASE BOMBS'] - TSS 1/27/03 (0) # Re: [Docket No. 99-017-2] Blood and Tissue Collection at Slaughtering Establishments [TSS SUBMISSION] 01N-0423 Substances Prohibited from use in animal food/Feed Ruminant APE 5 National Renderers Association, Inc. Vol#: 2 APE 6 Animal Protein Producers Industry Vol#: 2 APE 7 Darling International Inc. Vol#: 2 EMC 1 Terry S. Singeltary Sr. Vol#: 3 TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES (Williams et al) {rebuttal, TSS et me;-} PART 1 part II # Docket No: 02-088-1 RE-Agricultural Bioterrorism Protection Act of 2002; [TSS SUBMISSION ON POTENTIAL FOR BSE/TSE & FMD 'SUITCASE BOMBS'] - TSS 1/27/03 (0) PDF]Freas, William TSS SUBMISSION File Format: PDF/Adobe Acrobat - Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary Sr. [] Monday, January 08,200l 3:03 PM freas ... EPA Comment Number: 550-2 Received: October 26, 1998 Subject: DOCKET # opp-00550 FEDERAL FOOD AND SAFETY PLAN!!! Docket No: 01-064-1 Title: Animal Disease Risk Assessment, Prevention, and Control Act Contact Person: Mr. William Macheel, (301) 734-4420 Comments Due: October 9, 2001 Received on E-comments 24. Terry S. Singeltary Sr. 8/22/01 thank you, kindest regards, I am sincerely, Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518 CJD WATCH

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