Docket Management
Docket: 02N-0273 - Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
Comment Number: EC -11

Accepted - Volume 2

Comment Record
Commentor Mr. Terry Singeltary Date/Time 2003-01-15 14:24:45
Organization CJD WATCH
Category Individual

Comments for FDA General
Questions
1. General Comments PART 2 continued from part 1...TSS >>>nothing personal Linda, take care, and may the New Year bring >>> >>>PEACE... >>> >>>TSS >>> >>>CVM HomePage wrote: >>> >>> >>>>Dear Mr. Singeltary: >>>> >>>>As mentioned in my e-mail of December 4, FDA's Center for Veterinary >>>>Medicine never posted the Warning Letters for ruminant feed violations on >>>>our BSE page -- http://www.fda.gov/cvm/index/bse/bsetoc.html. However, >>>>these Warning Letters have been included on the FDA Warning Letters >>>>page >>>>-- http://www.fda.gov/foi/warning.htm that is located on the FDA's >>>>Electronic Freedom of Information Reading Room page. But, not as a >>>>separate category of Warning Letters for violations of the ruminant feed >>>>rules. >>>> >>>>I checked the Warning Letter page, and found that quite a few Warning >>>>Letters have been posted since May; however, I did not find any more >>>>recent >>>>than May 7, 2002, regarding Animal Proteins Prohibited in Ruminant >>>>Feed/Misbranded (ruminant feed rule violations.) You may wish to >>>>file a >>>>Freedom of Information Act (FOIA) request to determine if more recent >>>>Warning Letters have been issued, but not posted on the FDA Home Page. >>>>Information about filing a FOIA request may be found at: >>>>http://www.fda.gov/opacom/backgrounders/foiahand.html >>>> >>>>As mentioned on the CVM and Ruminant Feed (BSE) Inspections site -- >>>> >>>>After March 11, 2002, FDA discontinued the database that was used to >>>>compile these listings. The Agency started a new database on April 15, >>>>2002, >>>>and future updates on BSE enforcement and inspectional findings will draw >>>>from it. The format of the information presented here may change, due to >>>>design changes of the new database. This site will be updated after a >>>>period >>>>of time that allows for transition into the new database system. >>>> >>>>Unfortunately, the new database is much more complicated than the old >>>>one, >>>>and it does not lend itself to presenting data in a simple spreadsheet >>>>as we >>>>did in the past. Please be assured that CVM is working to solve this >>>>problem, and we do plan to post this data in the future. >>>> >>>>We have nothing new to report at this time. >>>> >>>>I hope that this information is helpful. >>>> >>>>Sincerely yours, >>>> >>>>Linda A. Grassie for the FDA Home Page >>>> >>>> >>>>-----Original Message----- >>>>From: Terry S. Singeltary Sr. [mailto:flounder@wt.net] >>>>Sent: Saturday, December 21, 2002 4:03 PM >>>>To: CVMHomeP@cvm.fda.gov >>>>Subject: USA ruminant-to-ruminant feed ban warning letters ??? >>>> >>>> >>>>Greetings, >>>> >>>>i have noticed the inspections and warning letters >>>>from firms not complying with the ruminant-to-ruminant >>>>feed ban violations has not been updated since (March 11, 2002)? >>>> >>>>2) Firms Currently Considered as Not in Compliance with the BSE Feed >>>>Rule >>>> >>>>The following spreadsheet is a subset of Spreadsheet 1 and contains the >>>>name, address, and firm identifier of all firms that were considered as >>>>not being in compliance with the BSE feed regulation at their most >>>>recent inspection, according to the BSE inspection database. Compliance >>>>status was determined by examination of the BSE Inspection Checklist. >>>>The dates of the inspections and the specific BSE provision violations >>>>for each inspection are also included. The listing is organized >>>>alphabetically first by the FDA District and then by the state in which >>>>the inspected facility is located. >>>> >>>>Most Recent BSE Inspections, Firms Not in Compliance >>>> >>>>http://www.fda.gov/cvm/efoi/InpectionListDescriptionforHP.htm >>>> >>>>i would be interested to know if all firms are now complying and that no >>>>warning letters have been issued since may of 2002, or have they just not >>>>been posted? >>>> >>>>if so, how can i locate them? >>>> >>>>thank you, >>>>kind regards, >>>>terry ======================================================= TRIPLE FIRE WALLS OF WHAT ??? NOW about those triple fire walls and imports and what about these potential biological 'TSE/FMD SUITCASE BOMBS'. omitting the 44 tons of MBM/GREAVES we imported from the UK; Subject: Re: exports from the U.K. of it's MBM to U.S.??? From: S.J.Pearsall@esg.maff.gsi.gov.uk Date: Tue, 8 Feb 2000 14:03:16 +0000 To: flounder@wt.net (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 Simon as discussed thanks Julie --- Forwarded message: Sent: Fri Feb 04 21:47:01 2000 Received: Fri Feb 04 21:45:15 2000 ========================================= or what about these potential BSE/TSE imports; 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 http://mad-cow.org/~tom/sept_mid_98_news.html#offals and if there is BSE in sheep, here is UK sheep/goat export; http://www.vegsource.com/articles/sheep_exports.htm BSE/TSE MADCOW SUITCASE BOMBS USCS=UNSPECIFIED SPECIES CODING SYSTEM=ANYTHING GOES THE USA SEALED BORDERS ARE LEAKING, AND HAVE BEEN FOR DECADES...TSS Date: Thu, 21 Mar 2002 08:42:56 -0800 Reply-To: Bovine Spongiform Encephalopathy Sender: Bovine Spongiform Encephalopathy From: Terry S. Singeltary Sr. Subject: USA SEALED BORDERS AND THE ''USCS'' (unspecified species coding system) MORE POTENTIAL B.S.eee Change in Disease Status of Greece With Regard to Foot-and-Mouth [Federal Register: March 21, 2002 (Volume 67, Number 55)] snip... Under Sec. 94.11, meat and other animal products of ruminants and swine, including ship stores, airplane meals, and baggage containing these meat or animal products, may not be imported into the United States except in accordance with Sec. 94.11 and the applicable requirements of the U.S. Department of Agriculture's Food Safety and Inspection Service at 9 CFR chapter III. snip... From an economic standpoint, the proposed rule would have little or no impact on U.S. animal stock and commodities. There are two reasons. First, the proposed rule would not remove other disease-based restrictions on the importation of ruminants or swine (and certain meat and other products from those animals) from Greece into the United States. Because bovine spongiform encephalopathy is considered to exist in Greece, the importation of ruminants and meat, meat products, and certain other products of ruminants that have been in Greece is prohibited. snip... http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2002_register&docid=02-6837-filed ======================== What are the U.S. imports of affected animals or animal products from the country? Very few products that would be of risk for transmission of BSE were imported into the US from Greece during 2000 or 2001 (January - April). Due to the above mentioned import ban, no live ruminants, ruminant meat, meal made from ruminants, or other high risk products from ruminants were imported from Greece during this time period. In 2001 (January - April), 3000 kg of enzymes and prepared enzymes and 5 kg of medicants containing antibiotics for veterinary use were imported. The data do not provide a species of origin code for these products, therefore they may not contain any ruminant product. Sources: World Trade Atlas What is the level of passenger traffic arriving in the United States from the affected country? Approximately 185,000 direct flights from Greece arrived to US airports in fiscal year 2000. Also, an unknown number of passengers from Greece arrived via indirect flights. Under APHIS-PPQ's agriculture quarantine inspection monitoring, 584 air passengers from Greece were sampled for items of agricultural interest in fiscal year 2000. Of these passengers, 14 carried meat (non-pork) items that could potentially transmit pathogens that cause BSE; most passengers carried from one to two kilograms (kg) of meat, although one passenger in November 1999 carried 23 kg of meat in a suitcase. Florida, Massachusetts, and New York were the reported destinations of these passengers. None of the passengers with meat items reported plans to visit or work on a ranch or farm while in the US. Source: US Department of Transportation, and APHIS-PPQ Agricultural Quarantine Inspection data base http://www.aphis.usda.gov/vs/ceah/cei/bse_greece0701.htm Greetings list members, i just cannot accept this; > 23 kg of meat in a suitcase (suitcase bomb...TSS) > The data do not provide a species of origin code for these > products, therefore they may not contain any ruminant product. what kind of statement is this? how stupid do they think we are? it could also very well mean that _all_ of it was ruminant based products ! Terry S. Singeltary Sr., Bacliff, Texas USA What is the level of passenger traffic arriving in the United States from Slovenia? There were no direct flights from Slovenia to the US in fiscal year 2000. APHIS-PPQ’s agriculture quarantine inspection monitoring sampled 27 air passengers from Slovenia for items of agricultural interest in fiscal year 2000. One of these 27 passengers was carrying two kilograms of a meat item that could potentially harbor pathogens that cause BSE. This passenger arrived to Elizabeth, New York, in June 2000 and declared no intention to visit a farm or ranch in the US. Source: US Department of Transportation, and APHIS-PPQ Agricultural Quarantine Inspection data base http://www.aphis.usda.gov/vs/ceah/cei/bse_slovenia1101.htm What is the level of passenger traffic arriving in the United States from the affected country? A total of 45,438 passengers arrived in the US on direct flights from the Czech Republic in fiscal year 2000. It is likely that additional passengers originating in the Czech Republic traveled to the US on non-direct flights. As part of APHIS-PPQ’s Agriculture Quarantine Inspection Monitoring, 238 air passengers from the Czech Republic were inspected for items of agricultural interest in fiscal year 2000. Of these, 10, or 4.2%, were found to be carrying a total of 17 kg of items that could potentially present a risk for BSE. None of the passengers with items reported plans to visit or work on a farm or ranch while in the US. Source: US Department of Transportation, and APHIS-PPQ Agricultural Quarantine Inspection data base http://www.aphis.usda.gov/vs/ceah/cei/bse_cz0601.htm What are the US imports of affected animals or animal products from Austria? Between 1998 and June 2001, US imports from Austria included goat meat, animal feeds, and sausage. The sausage and animals feeds were from unspecified species. Source: World Trade Atlas snip... What is the level of passenger traffic arriving in the United States from Austria? A total of 168,598 passengers on direct flights from Austria arrived at US airports in fiscal year 2000. An undetermined number of passengers from Austria arrived in the US via indirect flights. Under APHIS-PPQ’s agricultural quarantine inspection monitoring, 565 air passengers from Austria were sampled for items of agricultural interest in fiscal year 2000. Ten (10) of these passengers, or 1.7 percent, carried a total of 23 kg meat (non-pork) items that could potentially harbor the pathogen(s) that cause BSE. None of these passengers from whom meat items were confiscated reported plans to visit or work on a ranch or farm during their visit to the US. Source: US Dept. of Transportation; APHIS-PPQ http://www.aphis.usda.gov/vs/ceah/cei/bse_austria1201.htm Greetings FDA and public, if you go to the below site, and search all BSE known countries and check out their air traffic illegal meat they have confiscated, and check out the low number checked, compared to actual passenger traffic, would not take too much for some nut to bring in FMD/TSEs into the USA as a 'suitcase bomb'. [[Under APHIS-PPQ's agricultural quarantine inspection monitoring, 284 air passengers from Israel were sampled for items of agricultural interest in fiscal year 2001. Seven of these passengers, or 2 percent, carried a total of 11 kg of meat items that could potentially harbor the pathogen that causes BSE. None of these passengers from whom meat items were confiscated reported plans to visit or work on a ranch or farm during their visit to the U.S.]] if they were to have questioned the terrorist that bombed the Twin Towers with jets, if they were to have questioned them at flight school in the USA, i am sure that they would have said they did not intend to visit the Twin Towers as a flying bomb either. what am i thinking, they probably did ask this? stupid me. [[In 1999 a small amount of non-species specific meat and offal was imported and a small amount of fetal bovine serum (FBS) was also imported. FBS is considered to have a relatively low risk of transmitting BSE.]] more of the USA infamous 'non-species coding system', wonder how many of these species are capable of carrying a TSE? snip... A total of 524,401 passengers arrived on direct flights to the U.S. from Israel in fiscal year 2000. This number does not include passengers who arrived in the U.S. from Israel via indirect flights. Under APHIS-PPQ's agricultural quarantine inspection monitoring, 284 air passengers from Israel were sampled for items of agricultural interest in fiscal year 2001. Seven of these passengers, or 2 percent, carried a total of 11 kg of meat items that could potentially harbor the pathogen that causes BSE. None of these passengers from whom meat items were confiscated reported plans to visit or work on a ranch or farm during their visit to the U.S. http://www.aphis.usda.gov/vs/ceah/cei/bse_israel0602.htm Source: U.S. Department of Transportation and APHIS-PPQ Agricultural Quarantine Inspection data base. What is the level of passenger traffic arriving in the United States from Japan? Approximately 6.84 million passengers on 29,826 direct flights from Japan arrived at US airports in fiscal year 2000. An undetermined number of passengers from Japan arrived in the US via indirect flights. Under APHIS-PPQ's agriculture quarantine inspection monitoring, 801 air passengers from Japan were sampled for items of agricultural interest in fiscal year 2000. Of these 801 passengers, 10 carried meat (non-pork) items that could potentially harbor the pathogen(s) that cause BSE; most passengers carried an average of 1.7 kilograms of meat. None of these passengers from whom meat items were confiscated reported plans to visit or work on a ranch or farm during their visit to the US. Source: US Department of Transportation, and APHIS-PPQ Agricultural Quarantine Inspection data base http://www.aphis.usda.gov/vs/ceah/cei/bse_japan0901.htm What is the level of passenger traffic arriving in the United States from the affected country? A total of 3.3 million passengers arrived in the US on direct flights from Germany in 1998, although many of these passengers would not have originated in Germany. As part of APHIS-PPQ's Agriculture Quarantine Inspection Monitoring, 8,247 air passengers from Germany were inspected for items of agricultural interest. Of these, 198, or 2.3%, were found to be carrying a total of 304 kg of items that could potentially present a risk for BSE. Thirty (30) of the passengers with items reported plans to visit or work on a farm or ranch while in the US. Reported destination states of these 30 passengers were CA, CO, DE, FL, LA, MT, OH, VA, and WY. Source: US Department of Transportation, and APHIS-PPQ Agricultural Quarantine Inspection data base http://www.aphis.usda.gov/vs/ceah/cei/bse_germany1200e.htm search archives at bottom of page of each BSE Country; http://www.aphis.usda.gov/vs/ceah/cei/iw_archive.htm kind regards, Terry S. Singeltary Sr., Bacliff, Texas USA more on non-species coding system and TSEs and potential 'suitcase bombs' http://www.vegsource.com/talk/madcow/messages/9911936.html http://www.vegsource.com/talk/madcow/messages/9911943.html ========================================================== ANOTHER COW GOES DOWN WITH CWD IN LAB STUDIES; Subject: Re: CWD TO CATTLE by inoculation (ok, is it three or four???) Date: Wed, 11 Dec 2002 23:20:41 +0000 From: Steve Dealler Reply-To: Bovine Spongiform Encephalopathy Organization: Netscape Online member To: BSE-L References: Dear Dr Miller, I have to admit it was difficult to me to believe either....but in the end I just had to realise that it was true. When I investigated the age at which cattle actually were becoming infected it was shocking to find that the majority were infected under 1 month of age (and many of them seemed to be within the first week, although the data on this was more shakey, and the rest seemed to be infected in a decreasing slope up to the 7th month. The question was: just how could the cattle be infected simply so young? What also was turning out was that I could not find any obvious sign of multipoint inoculation and it was as if either there was a major dose arriving at one point or not at all. Again the maths on that was difficult but would probably stand up to the logic. These figures could only be certain in the period on either of the feed ban in the UK in 1988: but then again there was no change in the age distrubution after some other factors are removed since that point. For a long time we had been wondering why, during the epidemic, the age distribution of cases did not change greatly, when the actual amount of infectivity in the total diet of the battle population may have gone up 10,000fold. Surely, if infection was taking place at many points in an animal's life then they would have been becoming younger when dying of disease as the epidemic progressed?..but this was not seen. So...when you argue that a lamb is unlikely to have been infected naturally at a single point....I think that this is almost certainly incorrect and that they are indeed infected when exceedingly young and probably at a single point. Also I now believe that the amount of infectivity needed to infect these animals is likely to be very low compared with adults when given orally. (this was all published in the British Food Journal in 2001) Steve Dealler Janice M. Miller wrote: > ######## Bovine Spongiform Encephalopathy ######### > > I did not mean to imply that it wouldn't be possible for an animal to > consume that amount of material, especially over a lifetime. I was > merely pointing out that it is unlikely a lamb would be naturally > exposed to that amount of material at a single time point early in its > life and therefore such a short incubation period would not be expected > to occur under non-experimental conditions. > > >>> flounder@WT.NET 12/09/02 12:35PM >>> > > > hello Dr. Miller, > > i was curious about this statement; > > > It was not a true natural exposure, however, because they fed > > > the lambs 2-5 grams of infectious brain, which is very likely a > > > much larger dose than would occur under natural conditions. > > how do you come to the conclusion that 2-5 grams is a > 'much larger dose than would occur under natural conditions', > considering 1/2 to 1 gram is lethal for a cow ? > > FDA has determined that each animal could have consumed, at most and > in > total, five-and-one-half grams - approximately a quarter ounce -- of > prohibited material. These animals weigh approximately 600 pounds. > > http://www.fda.gov/bbs/topics/news/2001/new00752.html > > if we look at these studies, we will find that > the 5.5 grams would be more than sufficient to > infect a cow, if the feed was tainted with TSEs...TSS > > please read page 4, 5 and 6 of some 53; > > Scientific Steering Committee > ORAL EXPOSURE OF HUMANS TO THE BSE AGENT: > INFECTIVE DOSE AND SPECIES BARRIER > > http://europa.eu.int/comm/food/fs/sc/ssc/out79_en.pdf > > 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. > > [FULL TEXT ABOUT 600 PAGES] > 3681t2.rtf > http://www.fda.gov/ohrms/dockets/ac/cber01.htm > > thank you, > > kind regards, > terry > > Janice M. Miller wrote: > > > > With scrapie it's believed that most infections occur at or > shortly > > after birth, either from exposure to placenta from the lamb's own > > infected dam or from another placent of another infected ewe that is > > lambing at the same time. There are several experiments reported, > > however, in which older sheep from scrapie-free flocks have been put > in > > contact with lambing ewes from scrapie flocks and transmission has > > occurred. In these cases the incubation period appears to be > longer. > > Recently we heard in England that they have been able to reproduce > > scrapie within 6 months (an incredibly short incubation period for > that > > disease) by oral exposure of 2-week old lambs. It was not a true > > natural exposure, however, because they fed the lambs 2-5 grams of > > infectious brain, which is very likely a much larger dose than would > > occur under natural conditions. The effect of age on incubation > period > > may reflect the amount of lymphoid tissue available in the > intestinal > > tract of lambs because they experience a significant amount of > atrophy > > in that tissue diromg the first year of life. I don't remember > anyone > > suggesting that age plays a role in either the success of > transmissions > > or incubation periods when sheep are inoculated initracerebrally. > That > > seems to depend mostly on infectious titer of the inoculum and the > > genetics of the recipient sheep. > > In CWD no one has found any evidence that placenta is > infectious > > so the source of infectivity for transmission is unknown. In the > highly > > contaminated wildlife research facility at Colorado they lose over > 90% > > of their deer by about 2 years of age so it is likely that those > animals > > are infected at a very young age. In the wild, however, they are > > reporting some positive animals that are much older so while there > might > > be some development of resistance with age, it certainly isn't > complete. > > I don't know that anyone has reported doing experiments where > CWD-free > > deer of different ages were put into a contaminated environment to > see > > if the transmission rates or incubation periods would be influenced > by > > age. > > > > > >>>>taotm@EARTHLINK.NET 11/26/02 08:24AM >>> > >>> > > > > Dr. Miller, > > > > About a year ago there was a report of from a Colorado DoW staffer > who > > recalled seeing scrapie sheep in > > pens near the sickly-looking deer at the Ft. Collins research > facility. > > Although there's some debate about > > whether those sheep actually had scrapie, given the results of the > > intercerebral tests-- ... The other > > sheep, necropsied 35 months after inoculation, showed clinical signs > > and histopathologic lesions that were > > indistinguishable from scrapie...-- has there been any attempt to > > recreate the alleged conditions at Ft. > > Collins? In other words, an environmental test where scrapie sheep > > would be put in close proximity to > > healthy deer? Clearly there's a huge questions about the mechanics > of > > jumping the species barrier. But is > > it possible that this was the way the CWD prion fire was initially > lit? > > Farmed sheep to wild cervids? > > > > Also, have there been any tests looking at the age at which an > animal > > becomes infected? Are younger, > > smaller animals more at risk? Does the same dose of infectious > material > > as given an adult affect them > > faster or more intensely? > > > > thank you, > > > > Janet Ginsburg > > > > Terry S. Singeltary Sr. wrote: > > > >>hello Janice, > >> > >>many thanks for this update. > >> > >> > we do not know if the CWD agent in white-tailed deer > >> > would be equivalent to that obtained from mule deer. > >> > >>i was just reading some data where it states; > >> > >>Although few white tailed deer were available for biopsy, > >>findings were consistent with those in mule deer and > >>support similarity in lymphoid accumulation of PrPCWD > >>between the species that has been observed post-mortem. > >>However, because PrPCWD does not appear to accumulate > >>in lymphoid tissue to the same degree in elk as deer > >>(T.R. Spraker, unpublished data) > >> > >>i am confused? > >> > >>thank you, > >>kind regards, > >> > >>terry > >> > >>Janice M. Miller wrote: > >> > > > >>> The statement that 4 cattle have developed evidence of CWD > >> > > transmission > > > >>>following intracerebral inoculation is correct because an > >> > > additional > > > >>>animal has been found prion positive subsequent to the 2001 paper > >> > > that > > > >>>presented preliminary findings after only 2 and a half years of > >>>observation. Following this message is a summary of the current > >> > > status > > > >>>of our CWD cross-species transmission experiments in cattle and > >> > > sheep. > > > >>>This information was prepared in anticipation of questions about > >> > > these > > > >>>studies that we expected would be raised at the recent annual > >> > > meeting of > > > >>>the U.S. Animal Health Association. > >>> I would like to correct one statement in the newspaper > >> > > article > > > >>>that was attributed to me that is in error. I did not imply that > >> > > our > > > >>>work thus far could be extrapolated to the situation with > >> > > white-tailed > > > >>>deer and dairy cattle. While there is no indication that there > >> > > should > > > >>>be any difference in susceptibility of beef versus dairy cattle, we > >> > > do > > > >>>not know if the CWD agent in white-tailed deer would be equivalent > >> > > to > > > >>>that obtained from mule deer. For that reason Dr. Hamir is now > >>>repeating the original experiment in cattle with brain suspension > >> > > from > > > >>>affected white-tails as inoculum. > >>> > >>>Experimental Transmission of Chronic Wasting Disease (CWD) to > >> > > Cattle > > > >>>and Sheep > >>>Progress report - October 15, 2002 > >>> > >>>Transmission of CWD (mule deer) to cattle: > >>> > >>>Background: > >>>In 1997, 13 calves were inoculated intracerebrally with brain > >>>suspension from mule deer naturally affected with CWD. During the > >> > > first > > > >>>3 years, 3 animals were euthanized 23, 24, and 28 months after > >>>inoculation because of weight loss (2) or sudden death (1). > >> > > Although > > > >>>microscopic examination of the brains did not show classical > >> > > lesions of > > > >>>transmissible spongiform encephalopathy (TSE), a specific TSE > >> > > marker > > > >>>protein, PrPres, was detected by immunohistochemistry (IHC) and > >> > > western > > > >>>blot . Detailed information on these animals has been published > >>>previously (A Hamir et al., J Vet Diagn Invest 13: 91-96, 2001). > >>> > >>>Update: > >>>During the 3rd and 4th years of observation, 5 additional animals > >> > > have > > > >>>been euthanized because of health concerns (primarily chronic joint > >> > > and > > > >>>foot problems). Although all tests for PrPres are not complete, > >> > > IHC > > > >>>results indicate that 1 of these animals, necropsied 59 months > >> > > after > > > >>>inoculation, was positive for PrPres. This animal (# 1746) had not > >> > > been > > > >>>eating well for approximately 1 week prior to being found > >> > > recumbent. At > > > >>>necropsy, significant gross lesions consisted of an oblique > >> > > fracture of > > > >>>L1 vertebral arch with extension into the body, and moderate > >> > > multifocal > > > >>>hemorrhagic ulceration in the abomasum. Microscopic examination > >> > > of > > > >>>brain revealed a few isolated neurons with single or multiple > >> > > vacuoles, > > > >>>but neither neuronal degeneration nor gliosis was observed. IHC > >>>revealed the presence of PrPres in sections from several areas of > >> > > the > > > >>>brain. > >>> > >>>Summary of findings on this case and data from previous animals: > >>> > >>> Necropsy Survival Disease Clinical > >>>Histo- IHC SAF WB > >>> No. Route date period course signs > >> > > pathology > > > >>>________________________________________________________________ > >>> > >>>1745 i/c 8/18/99 23m 2m + > >>>+/- + - + > >>> > >>>1768 i/c 9/22/99 24m 3m + > >>>+/- + + + > >>> > >>>1744 i/c 1/29/00 28m 3d +/- > >>>- + + + > >>> > >>>1749 i/c 5/20/01 44m NA - > >>> - - NT NT > >>> > >>>1748 i/c 6/27/01 45m NA - > >>>- - NT NT > >>> > >>>1743 i/c 8/21/02 59m NA - > >>>- - Pending Pending > >>> > >>>1741 i/c 8/22/02 59m NA - > >>>- - Pending Pending > >>> > >>>1746 i/c 8/27/02 59m 7d +/- > >>>+/- + Pending Pending > >>> > >>>NT = not tested; IHC = immunohistochemistry for PrPres; SAF = > >> > > scrapie > > > >>>associated fibrils; NA = not applicable; WB = Western blot > >>>(Prionics-Check); + = lesions or antigen present; - = lesions or > >>>antigen absent; +/- = signs/lesions equivocal; i/c = intracerebral; > >> > > m = > > > >>>months; d = days. > >>> > >>>Summary: > >>>After 5 years of observation we have 4 CWD transmissions to cattle > >> > > from > > > >>>a group of 13 inoculates. These animals, which were necropsied 23, > >> > > 24, > > > >>>28, and 59 months after inoculation, did not show the clinical > >> > > signs or > > > >>>histopathologic lesions typical of a TSE, but PrPres was detected > >> > > in > > > >>>brain samples. Four other animals that were necropsied during the > >> > > 4th > > > >>>and 5th years of observation have not shown evidence of prion > >> > > disease > > > >>>(although not all tests are complete) and the 5 remaining cattle > >> > > are > > > >>>apparently healthy. Note that this study involved direct > >> > > intracerebral > > > >>>inoculation of cattle with the CWD agent, which is an unnatural > >> > > route of > > > >>>exposure. It is likely that transmission by a more natural route, > >> > > such > > > >>>as oral exposure, would be much more difficult to accomplish. > >> > > Cattle > > > >>>have been inoculated orally at the University of Wyoming with the > >> > > same > > > >>>inoculum used for this experiment, and 5 years into the study > >> > > these > > > >>>animals remain healthy. > >>> > >>> > >>>Experimental Transmission of CWD (mule deer) to sheep > >>> > >>>Eight Suffolk sheep from the NADC scrapie-free flock were > >> > > inoculated > > > >>>intracerebrally with the CWD brain suspension used to inoculate > >> > > cattle. > > > >>>PRNP genotyping showed that 4 of the sheep were QQ at codon 171 and > >> > > the > > > >>>other four were QR. Two of the QQ sheep were euthanized during the > >> > > 3rd > > > >>>year of observation. At necropsy one of these animals had a > >> > > urethral > > > >>>obstruction and PrPres was not detected in brain or lymphoid > >> > > tissues. > > > >>>The other sheep, necropsied 35 months after inoculation, showed > >> > > clinical > > > >>>signs and histopathologic lesions that were indistinguishable from > >>>scrapie. IHC tests showed typical PrPres accumulations in brain, > >>>tonsil, and some lymph nodes. The 2 remaining QQ sheep and all 4 > >> > > QR > > > >>>sheep are apparently healthy 39 months after inoculation. > >>> > >>>Summary: > >>>After 3 years of observation we have 1 transmission of CWD to a 171 > >> > > QQ > > > >>>sheep. This animal, which was necropsied 35 months after > >> > > inoculation, > > > >>>showed clinical signs and histopathologic lesions that were > >>>indistinguishable from scrapie. Another QQ sheep that was > >> > > necropsied > > > >>>during the 3rd year showed no evidence of prion disease and all > >>>remaining sheep (2 QQ and 4 QR) are apparently healthy. > >>> > >>> > >>>>>>flounder@WT.NET 11/23/02 06:54PM >>> > >>>>>> > >>> > >>>1: J Vet Diagn Invest 2001 Jan;13(1):91-6 > >>> > >>>Preliminary findings on the experimental transmission of chronic > >>>wasting > >>>disease agent of mule deer to cattle. > >>> > >>>Hamir AN, Cutlip RC, Miller JM, Williams ES, Stack MJ, Miller MW, > >>>O'Rourke KI, Chaplin MJ. > >>> > >>>National Animal Disease Center, ARS, USDA, Ames, IA 50010, USA. > >>> > >>>To determine the transmissibility of chronic wasting disease (CWD) > >> > > to > > > >>>cattle and to provide information about clinical course, lesions, > >> > > and > > > >>>suitability of currently used diagnostic procedures for detection > >> > > of > > > >>>CWD > >>>in cattle, 13 calves were inoculated intracerebrally with brain > >>>suspension from mule deer naturally affected with CWD. Between 24 > >> > > and > > > >>>27 > >>>months postinoculation, 3 animals became recumbent and were > >>>euthanized. > >>>Gross necropsies revealed emaciation in 2 animals and a large > >>>pulmonary > >>>abscess in the third. Brains were examined for protease-resistant > >>>prion > >>>protein (PrP(res)) by immunohistochemistry and Western blotting > >> > > and > > > >>>for > >>>scrapie-associated fibrils (SAFs) by negative-stain electron > >>>microscopy. > >>>Microscopic lesions in the brain were subtle in 2 animals and > >> > > absent > > > >>>in > >>>the third case. However, all 3 animals were positive for PrP(res) > >> > > by > > > >>>immunohistochemistry and Western blot, and SAFs were detected in 2 > >> > > of > > > >>>the animals. An uninoculated control animal euthanized during the > >> > > same > > > >>>period did not have PrP(res) in its brain. These are preliminary > >>>observations from a currently in-progress experiment. Three years > >>>after > >>>the CWD challenge, the 10 remaining inoculated cattle are alive > >> > > and > > > >>>apparently healthy. These preliminary findings demonstrate that > >>>diagnostic techniques currently used for bovine spongiform > >>>encephalopathy (BSE) surveillance would also detect CWD in cattle > >>>should > >>>it occur naturally. > http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11243374&dopt=Abstract > > >>>Sat, Nov 23, 2002 > >>> > >>>Scientists unsure if CWD can jump species > >>> > >>>By Jessica Bock > >>>Wausau Daily Herald > >>>jbock@wdhprint.com > >>> > >>>snip... > >>> > >>>Janice Miller, a veterinarian in charge of the experiment, said > >> > > she > > > >>>believes previous research shows it is hard for the disease to be > >>>transmitted naturally from whitetail deer to dairy cattle. > >>>Our study says nothing of how it could be transmitted in natural > >>>surroundings, she said. > >>> > >>>Miller has been studying the transmission of CWD from mule deer to > >>>cattle since 1997. Since then, chronic wasting disease was > >> > > transmitted > > > >>>to four out of 13 cattle injected with brain tissue from naturally > >>>infected mule deer, she said. > >>> > >>>In Wyoming, Williams has been studying cattle that were given a > >>>concoction of diseased brain tissue orally, and five years into > >> > > the > > > >>>study the animals remain healthy, Miller said. > >>>No one knows if chronic wasting disease could ever spread to > >> > > another > > > >>>species through natural surroundings. > >>> > >>>Our experience is that it's pretty hard to predict, Miller said. > >>> > >>>http://www.wausaudailyherald.com/wdhlocal/277564794712612.shtml > >>> > >>>greetings list, > >>> > >>> > Since then, chronic wasting disease was > >>> > >>> > transmitted to four out of 13 cattle > >>> > >>>is this a typo by the media or has another cow gone down > >>>with CWD since the preliminary findings were found? > >>> > >>>TSS ======================================================= scrapie in USA increasing; 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: flounder@wt.net 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). http://www.aphis.usda.gov/vs/nahps/scrapie/annual_report/annual-report.html NEW SCRAPIE INFECTED AND SOURCE FLOCKS http://www.aphis.usda.gov/vs/nahps/scrapie/annual_report/figure04.gif DISTRIBUTION OF CHRONIC WASTING DISEASE THROUGHOUT THE STATES (as of Oct. 2002) http://www.aphis.usda.gov/vs/nahps/cwd/cwd-distribution.html CWD USA surveillance http://www.aphis.usda.gov/vs/nahps/cwd/cwd-state.html http://www.testcowsnow.com TSS ================================================== we must _never_ forget the work of the late Dr. Richard Marsh; 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... http://www.bseinquiry.gov.uk/files/yb/1989/08/29003001.pdf 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... http://www.bseinquiry.gov.uk/files/yb/1987/06/10004001.pdf 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 TSS Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518 CJD WATCH http://www.fortunecity.com/healthclub/cpr/349/part1cjd.htm 'MOMS AUTOPSY REPORT' http://www.vegsource.com/talk/lyman/messages/7548.html http://www.vegsource.com/talk/madcow/index.html =============================================== January 13, 2003 Dockets Management Branch Food and Drug Administration 5630 Fishers Lane Room 1061 Rockville, MD 20852 Re: Docket No. 02N-0273 – Substances Prohibited From Use In Animal Food Or Feed; Animal Proteins Prohibited In Ruminant Feed; Advanced Notice Of Proposed Rulemaking Dear Sir/Madam: The undersigned organizations representing a coalition of the nation’s animal producers, feed and ingredient manufacturers, meat processors and animal care providers offer these comments to the above-referenced notice. Our organizations have and continue to support the current scientifically based animal feeding regulations that restrict the use of certain animal proteins derived from mammalian tissues for use in ruminant feed. A careful analysis of the facts suggests no regulatory changes are warranted at this time. FDA in 1997 adopted the current feed restrictions based on sound science and review of industry practices. We believe the existing FDA animal feed regulations are appropriate given the low level of risk that BSE will occur in the U.S. Our goal is not to change the regulations, but to achieve 100 percent compliance with the existing regulations. According to FDA, compliance with the BSE feed rule (21 C.F.R. § 589.2000) has been excellent. In fact, the coalition is unaware of any other FDA rule or program even approaching a near 100 percent compliance rate. BSE prevention in the U.S. involves multiple programs that can best be described as a triple firewall strategy. This includes: (1) a ban on the importation of ruminants and ruminant products from countries with BSE; (2) a statistically sound and comprehensive animal surveillance program to continually monitor for the presence of the disease; and (3) ruminant feeding restrictions to prevent the amplification and spread of the infective agent in the unlikely event BSE occurs in our domestic cattle. The current BSE feed rule, as part of this triple firewall strategy, is more than adequate to meet the objectives stated in the preamble to the final rule. In fact, several scientific studies have confirmed the fundamental soundness of the government’s approach and indicated our nation’s risk is extremely low. Neither current science nor the current excellent compliance rate supports an expansion of the rule at this time. The coalition agrees the rule needs to be reviewed from time-to-time and applauds the agency’s efforts to do so by conducting a public hearing on October 30, 2001 and publishing its Advanced Notice of Proposed Rulemaking (ANPR) on November 6, 2002. An occasional review of the rule will serve to strengthen it, if new risks are identified or new, relevant science is brought to light. However, no new risks or science support the proposed changes set forth in the ANPR. In fact, as the Harvard BSE Risk Assessment indicated, if BSE were to occur in the United States, the disease would not be able to sustain itself because of the current measures in place. Not only would the proposed changes have no appreciable effect on the risk of BSE occurring or proliferating in the U.S., the proposed changes would likely take away valuable resources that are needed to ensure full compliance with the current rules in place. Rigorous enforcement of the current feed rule will result in greater risk reduction than any or all of the proposed changes discussed in the ANPR. To that end, we urge the agency to continue to educate the regulated industries about the rule, continue active surveillance, assure compliance if violations are discovered, take vigorous enforcement actions against violators and continue the agency's cooperation and support of state inspection programs. The coalition believes FDA has been diligent in carrying out its responsibilities to reduce, as much as possible, the risk of BSE being introduced and amplified in the U.S. Our risk of BSE in domestic cattle is not zero, nor can it ever be, but our risk today is the lowest it has ever been since the disease was first recognized as a threat to the U.S. cattle population. We pledge our continuing commitment to a goal of 100 percent compliance and assuring that federal and state agencies have the necessary resources to achieve that goal. We thank the agency for the opportunity to submit these comments and for the agency’s consideration of them. Individual trade associations will offer additional comments on issues relevant to their members. Sincerely, American Farm Bureau Federation American Feed Industry Association American Meat Institute American Sheep Industry Association Fats and Proteins Research Foundation National Cattlemen's Beef Association National Chicken Council National Grain and Feed Association National Institute for Animal Agriculture National Milk Producers Federation National Meat Association National Pork Producers Council National Renderers Association National Turkey Federation Pet Food Institute http://www.meatami.com/Template.cfm?Section=BSE&NavMenuID=188&template=TaggedContentFile.cfm&NewsID=625 TSS




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