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Thread: Fda emergency request for rule change 589.2000

  1. #1
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    Default Fda emergency request for rule change 589.2000

    From: Terry Singeltary [mailto:flounder9@verizon.net]
    Sent: Tuesday, July 10, 2018 11:09 PM
    To: Legislation <Legislation@fda.hhs.gov>
    Cc: Alexander, Nicholas <Nicholas.Alexander@fda.hhs.gov>; Commissioner FDA <CommissionerFDA@fda.hhs.gov>; Kux, Leslie <Leslie.Kux@fda.hhs.gov>; Lorraine, Catherine C <Catherine.Lorraine@fda.hhs.gov>; Cohen, Kenneth <Kenneth.Cohen@fda.hhs.gov>; Dupont, Jarilyn <Jarilyn.Dupont@fda.hhs.gov>; Granger, Lisa C <Lisa.Granger@fda.hhs.gov>; CBER OMBUDSMAN <CBEROMBUDSMAN@fda.hhs.gov>; CDER OMBUDSMAN <cderombudsman@fda.hhs.gov>; CDER OMBUDSMAN <cderombudsman@fda.hhs.gov>; CDRH Ombudsman <CDRHOmbudsman@fda.hhs.gov>; CTPOmbudsman <CTPOmbudsman@fda.hhs.gov>; CVM OMBUDSMAN <CVMOMBUDSMAN@fda.hhs.gov>; Zeller, Jessica <Jessica.Zeller@fda.hhs.gov>; OC Ombudsman <Ombuds@OC.FDA.GOV>
    Subject: CONFIDENTIAL IN CONFIDENCE SPONGIFORM ENCEPHALOPATHY OF PIGS FDA EMERGENCY REQUEST FOR RULE CHANGE



    TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY TSE PRION DISEASE AKA MAD COW TYPE DISEASE



    Subject: CONFIDENTIAL IN CONFIDENCE SPONGIFORM ENCEPHALOPATHY OF PIGS FDA EMERGENCY REQUEST FOR RULE CHANGE

    Dear Commissioner Dr. Gottlieb Sir, and FDA et al,



    I am writing with great urgency about something that you should be very much aware of. Time I put my politics aside, this is just too important for humans and animals.



    How does a peon like me, request to FDA for an immediate hearing, request for ruling to the FDA, to propose amending the USA Section 21 C.F.R. 589.2000, Animal Proteins Prohibited in Ruminant Feed ban regulation, due to recent scientific findings, one that could have grave implications for man and animal around the globe?



    i am talking about mad cow disease again. it's gone no where, just spread and mutated, now cwd and scrapie transmits to pigs via oral route. cwd in cervid is spreading with no stopping it. this is not good.



    Please see here what I am speaking of Sir, 1ST, an old documented from BSE Inquiry, then new scientific findings, price of tse prion poker goes way up. we must not flounder any longer. I PRAY SOMEONE FINALLY TAKES ME SERIOUSLY! ...



    with kindest regards, very sincerely, terry



    From: Terry Singeltary <flounder9@verizon.net>
    Date: July 10, 2018 at 11:21:06 AM CDT
    To: bse-l@lists.aegee.org
    Cc: cjdvoice@yahoogroups.com, bloodcjd@yahoogroups.com
    Subject: CONFIDENTIAL IN CONFIDENCE SPONGIFORM ENCEPHALOPATHY OF PIGS

    *** ''but feeding of other ruminant protein, including scrapie-infected sheep, can continue to pigs.''



    CONFIDENTIAL SPONGIFORM ENCEPHALOPATHY OF PIGS



    CONFIDENTIAL



    Ref: Pigs10i



    IN CONFIDENCE



    Dr. Metters



    From Dr. H Pickles Med ISD/3



    Date 10 September 1990



    Copy: Dr G Jones Mr D Hagger Mr T Murray (o/r) Dr D Harper Dr Richardson Mrs Shersby



    SPONGIFORM ENCEPHALOPATHY OF PIGS



    1. There has been a preliminary meeting of the Tyrrell committee today to discuss the significance of the pig experiment in the light of other evidence, for example on feline spongiform encephalopathy.



    2. The preliminary conclusions were:



    we now know pigs are capable of expressing spongiform encephalopathy. Previously this had been doubted.



    the clinical picture in pigs exposed to agent by these doses/routes is fairly distinctive and unlikely to have gone unrecognised.



    even so improved monitoring/surveillance of neurological disease in older pigs should be considered.



    feeding of the "specified offal" (ie nervous/lymphoid tissue from cattle) should no longer be permitted, to pigs or to any other species.



    *** but feeding of other ruminant protein, including scrapie-infected sheep, can continue to pigs.



    if one natural field case of spongiform encephalopathy were described in a pig, we would need a ban on offal from for human consumption.



    we cannot rule out the possibility that unrecognised subclinical spongiform encephalopathy could be present in British pigs though there is no evidence for this: only with parenteral/implantable pharmaceuticals/devices is the theoretical risk to humans of sufficient concern to consider any action.



    90/9.10/7.1



    whilst any such action on pharmaceuticals/devices is for others to decide, this group (which includes 4 key members of the CSM group) suggests non-UK sources should now be used, at least for "high risk" pharmaceuticals and devices (ie for those from nervous or RE System)



    3. The full committee will meet on the 19th to confirm these conclusions, to review experimental protocols of transmission experiments, to reconsider the cat position in the light of additional cases and to consider scrapie in sheep and goats. In view of Mr Gummer's earlier commitments, we assume he willI want to go public on the pig soon after, so the Tyrrell committee will also prepare a brief written statement.



    4. You may want to consider with the MCA and the Medical Device Agency what preparatory action is appropriate in anticipation of the formal advice from the Tyrrell group. The CSM subgroup not due to meet until the 31 October.



    Hilary Pickles Room 414 Eileen House Ext: 22832



    http://web.archive.org/web/200308220...9/10007001.pdf



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    Detection of PrPres in peripheral tissue in pigs with clinical disease induced by intracerebral challenge with sheep-passaged bovine spongiform encephalopathy agent



    Carlos Hedman ,Alicia Otero ,Jean-Yves Douet,Caroline Lacroux,Séverine Lugan,Hicham Filali,Fabien Corbière,Naima Aron,Juan José Badiola,Olivier Andréoletti,Rosa Bolea



    Published: July 5, 2018



    Abstract

    Bovine spongiform encephalopathy (BSE) can be efficiently transmitted to pigs via intracerebral inoculation. A clear link has been established between the consumption of products of bovine origin contaminated with the BSE agent and the development of variant Creutzfeldt-Jakob disease in humans. Small ruminants can also naturally develop BSE, and sheep-adapted BSE (Sh-BSE) propagates more efficiently than cattle BSE in pigs and in mouse models expressing porcine prion protein. In addition, Sh-BSE shows greater efficiency of transmission to human models than original cow BSE. While infectivity and/or abnormal PrP accumulation have been reported in the central nervous system in BSE-infected pigs, the ability of the agent to replicate in peripheral tissues has not been fully investigated. We previously characterized the presence of prions in a panel of tissues collected at the clinical stage of disease from pigs experimentally infected with Sh-BSE. Western blot revealed low levels of PrPres accumulation in lymphoid tissues, nerves, and skeletal muscles from 4 of the 5 animals analysed. Using protein misfolding cyclic amplification (PMCA), which we found to be 6 log fold more sensitive than direct WB for the detection of pig BSE, we confirmed the presence of the Sh-BSE agent in lymphoid organs, nerves, ileum, and striated muscles from all 5 inoculated pigs. Surprisingly, PrPres positivity was also detected in white blood cells from one pig using this method. The presence of infectivity in lymphoid tissues, striated muscles, and peripheral nerves was confirmed by bioassay in bovine PrP transgenic mice. These results demonstrate the ability of BSE-derived agents to replicate efficiently in various peripheral tissues in pigs. Although no prion transmission has been reported in pigs following oral BSE challenge, our data support the continuation of the Feed Ban measure implemented to prevent entry of the BSE agent into the feed chain.



    http://journals.plos.org/plosone/art...l.pone.0199914




    Singeltary's comment;



    cwd and scrapie transmits to pigs orally and the USA Section 21 C.F.R. 589.2000, Animal Proteins Prohibited in Ruminant Feed ban WARNING

    Posted by flounder on 08 Jul 2018 at 21:05 GMT

    >>>Although no prion transmission has been reported in pigs following oral BSE challenge, our data support the continuation of the Feed Ban measure implemented to prevent entry of the BSE agent into the feed chain.<<<

    I would kindly like to bring urgent awareness to PLOS and the authors of this study, and the globe, the USA Section 21 C.F.R. 589.2000, Animal Proteins Prohibited in Ruminant Feed ban has been a failed policy since inception imo (see DEFRA report below), also, cervid that are potentially at risk of Chronic Wasting Disease CWD TSE Prion, are still allowed to be used as protein feed for livestock. But foremost, CWD and Scrapie TRANSMITS TO PIGS BY ORAL ROUTE. please see many many more tonnages of 589.2000, Animal Proteins Prohibited in Ruminant Feed right up to 2017. this is an extremely dangerous situation for the globe, especially with this new outbreak of TSE Prion disease in a new livestock species, i.e. camels in Nigeria, this is an extremely dangerous situation that has global ramifications and needs to be addressed asap, or risk spreading cwd tse prion from the USA and Canada further around the globe. please see;



    http://journals.plos.org/plosone/art...9-17927c1a2d60



    terry

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    Default

    2001

    ***> Terry,...Perhaps you could submit a request for ruling to the FDA on this issue to propose amending the regulation to include all animal foods, including pet foods.


    -----Original Message-----

    From: Robert A. LaBudde [mailto:ral@LCFLTD.COM]

    Sent: Tuesday, August 14, 2001 11:43 PM

    To: BSE-L@UNI-KARLSRUHE.DE

    Subject: Re: MAD COW/HORSE FEED BAN VIOLATIONS WARNING LETTER July 20, 2001

    ######## Bovine Spongiform Encephalopathy

    > ######### At 01:41 PM 8/14/01 -0700, Terry wrote:

    >DEPARTMENT OF HEALTH AND HUMAN SERVICE

    > >July 20, 2001 >

    >Our Investigator reported a telephone discussion with Mr. Barry G.

    >Harrison who identified himself as the Corporate Counsel of the Farnam

    >Companies, Inc. During this discussion Mr. Harrison, reportedly, claimed

    >the products in question are exempt from the cautionary statement

    >requirement. This claimed exemption is based on the fact the products

    >are intended only for the equine market and your firm defines horses as

    >pets. We cannot accept this claimed exemption because while some horses

    >may be held as pets, horses are also working animals and in some parts

    >of North America, food animals.

    > >Based on our knowledge of working ranches, horse feed is often stored in

    >the same general area as ruminant feed making a conspicuous cautionary

    >statenmit vital on feeds and supplements,

    >containing prohibited materials.

    Terry:

    Perhaps you should pester FDA about this "loophole". Apparently, "pet food" does not have to bear the warning labels specified for food animals.

    I can't see any serious objection to expanding the label requirement to ALL animal food, not just food animals.

    Also, horses are "ruminants", so it's disturbing that they might escape the feed ban by being classified as "pets". Another good reason to extend the warning labels and regulation to all animal foods.

    Perhaps you could submit a request for ruling to the FDA on this issue to propose amending the regulation to include all animal foods, including pet foods.

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

    Robert A. LaBudde, PhD, PAS, Dpl. ACAFS e-mail: ral@lcfltd.com Least Cost Formulations, Ltd. URL: http://lcfltd.com/ 824 Timberlake Drive Tel: 757-467-0954 Virginia Beach, VA 23464-3239 Fax: 757-467-2947

    "Vere scire est per causas scire"

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

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

    see old thread here;


    http://madcowfeed.blogspot.com/2017/...-pet-food.html


    WEDNESDAY, JULY 11, 2018

    CONFIDENTIAL IN CONFIDENCE SPONGIFORM ENCEPHALOPATHY OF PIGS FDA EMERGENCY REQUEST FOR RULE CHANGE USA Section 21 C.F.R. 589.2000

    http://transmissiblespongiformenceph...pongiform.html

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