From: Terry S. Singeltary Sr.
Sent: Monday, March 23, 2015 9:50 PM
Subject: Guidance for Industry Ensuring Safety of Animal Feed
Maintained and Fed On-Farm Draft Guidance FDA-2014-D-1180
Draft Guidance for Industry on Ensuring Safety of Animal Feed Maintained
and Fed On-Farm; Availability This Notice document was issued by the Food and
Drug Administration (FDA)
For related information, Open Docket Folder Docket folder icon
--------------------------------------------------------------------------------
Show agency attachment(s) DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and
Drug Administration [Docket No. FDA-2014-D-1180] Draft Guidance for Industry on
Ensuring Safety of Animal Feed Maintained and Fed On-Farm; Availability Agency
Food and Drug Administration, HHS.
Action Notice.
Summary The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry #203 entitled “Ensuring Safety of
Animal Feed Maintained and Fed On-Farm.” This draft guidance is intended to help
animal producers (persons who feed animals) develop and implement on-farm
practices to ensure the safety of animal feed maintained and fed to animals on
the farm.
Dates Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this draft
guidance before it begins work on the final version of the guidance, submit
either electronic or written comments on the draft guidance by June 3,
2015.
Addresses Submit written requests for single copies of the draft guidance
to the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and
Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one
self-addressed adhesive label to assist that office in processing your requests.
See the SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written
comments to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For Further Information Contact Phares Okelo, Center for Veterinary
Medicine (HFV-226), Food and Drug Administration, 7519 Standish Pl., Rockville,
MD 20855, 240-453-6862, email: phares.okelo@fda.hhs.gov.
Supplementary Information I. Background FDA is announcing the availability
of a draft guidance for industry # 203 entitled “Ensuring Safety of Animal Feed
Maintained and Fed On-Farm.” This draft guidance is intended to help animal
producers (persons who feed animals) develop and implement on-farm practices to
ensure the safety of animal feed maintained and fed to animals on the farm. In
this document, “farm” means animal production units such as integrated poultry
grower operations, swine finishing units, and cattle feedlots. This document
outlines basic measures that may be taken to maintain the safety of all types of
feed held on the farm for use in animal production. This draft guidance
recommends establishing measures to ensure the acquisition of safe feed and
maintenance of its safety until the feed is offered to animals in the farm
environment. This document does not address feed manufacture, which also may
occur on farms.
II. Significance of Guidance This level 1 draft guidance is being issued
consistent with FDA's good guidance practices regulation (21 CFR 10.115). The
draft guidance, when finalized, will represent the Agency's current thinking on
this topic. It does not create or confer any rights for or on any person and
does not operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statutes and
regulations.
III. Paperwork Reduction Act of 1995 FDA concludes that there are no
collections of information under the Paperwork Reduction Act of 1995.
IV. Comments Interested persons may submit either electronic comments
regarding this document to http://www.regulations.gov or written
comments to the Division of Dockets Management (seeADDRESSES). It is only
necessary to send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments may be seen
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through
Friday and will be posted to the docket at http://www.regulations.gov.
V. Electronic Access Persons with access to the Internet may obtain the
draft guidance at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm
or http://www.regulations.gov.
Dated: March 16, 2015. Leslie Kux, Associate Commissioner for Policy. [FR
Doc. 2015-06390 Filed 3-19-15; 8:45 am] BILLING CODE 4164-01-P
Contains Nonbinding Recommendations
Draft — Not for Implementation
1
#203
Guidance for Industry Ensuring Safety of Animal Feed Maintained and Fed
On-Farm Draft Guidance
This draft guidance document is for comment purposes only. Submit comments
on this draft guidance by the date provided in the Federal Register notice
announcing the availability of the draft guidance. Submit electronic comments to
http://www.regulations.gov. Submit
written comments to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All comments
should be identified with the docket number listed in the notice of availability
that publishes in the Federal Register. For further information regarding this
draft guidance document, contact Phares Okelo, Center for Veterinary Medicine
(HFV-226), Food and Drug Administration, 7519 Standish Place, Rockville, MD
20855, 240-453-6862, E-mail: Phares.Okelo@fda.hhs.gov. Additional copies of this
draft guidance document may be requested from the Policy and Regulations Staff
(HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7519
Standish Place, Rockville, MD 20855, and may be viewed on the Internet at either
http://www.fda.gov/AnimalVeterinary/default.htm
or http://www.regulations.gov. U.S.
Department of Health and Human Services Food and Drug Administration Center for
Veterinary Medicine March 2015
D. What feed safety precautions should I take in animal feeding? In
accordance with applicable federal regulations, you are required to: 1. Ensure
certain animal protein products, which could be a source of the Bovine
Spongiform Encephalopathy (BSE) agent, are not used in feed for ruminant animals
(21 CFR § 589.2000) or certain cattle origin materials in the food or feed of
all animals (21 CFR 589.2001), as applicable.
In addition, we recommend that you:
snip...
Greetings FDA et al,
I wish to comment on Guidance for Industry Ensuring Safety of Animal Feed
Maintained and Fed On-Farm Draft Guidance FDA-2014-D-1180.
Once again, I wish to kindly bring up the failed attempt of the FDA and the
ruminant to ruminant mad cow feed ban of August 4, 1997. This feed ban is still
failing today, as we speak. Even more worrisome, is the fact it is still legal
to feed cervids to cervids in the USA, in fact, the FDA only _recommends_ that
deer and elk considered to be of _high_ risk for CWD do not enter the animal
food chain, but there is NO law, it’s only voluntary, a recipe for a TSE prion
disaster, as we have seen with the ruminant to ruminant feed ban for cattle,
where in 2007, one decade post August 1997 mad cow feed ban, where in 2007
10,000,000 POUNDS OF BANNED BLOOD LACED MEAT AND BONE MEAL WHEN OUT INTO
COMMERCE, TO BE FED OUT. Since 2007, these BSE feed ban rules have been breached
time and time again. tons and tons of mad cow feed went out in Alabama as well,
where one of the mad cows were documented, just the year before in 2006, and in
2013 and 2014, breaches so bad (OAI) Official Action Indicated were issued.
those are like the one issued where 10 million pounds of banned blood laced meat
and bone meal were fed out.
What is the use of having a ‘Guidance for Industry Ensuring Safety of
Animal Feed Maintained and Fed On-Farm Draft Guidance FDA-2014-D-1180’, if it
cannot be enforced, as we have seen with a mandatory ruminant to ruminant feed
ban?
I strenuously once again urge the FDA and it’s industry constituents, to
make it MANDATORY that all ruminant feed be banned to all ruminants, and this
should include all cervids as soon as possible for the following
reasons...
In the USA, under the Food and Drug Administration’s BSE Feed Regulation (21 CFR 589.2000) most material (exceptions include milk, tallow, and gelatin) from deer and elk is prohibited for use in feed for ruminant animals. With regards to feed for non-ruminant animals, under FDA law, CWD positive deer may not be used for any animal feed or feed ingredients. For elk and deer considered at high risk for CWD, the FDA recommends that these animals do not enter the animal feed system.
***However, this recommendation is guidance and not a requirement by law.
=================================
Animals considered at high risk for CWD include:
1) animals from areas declared to be endemic for CWD and/or to be CWD
eradication zones and
2) deer and elk that at some time during the 60-month period prior to
slaughter were in a captive herd that contained a CWD-positive animal.
Therefore, in the USA, materials from cervids other than CWD positive
animals may be used in animal feed and feed ingredients for non-ruminants.
The amount of animal PAP that is of deer and/or elk origin imported from
the USA to GB can not be determined, however, as it is not specified in TRACES.
It may constitute a small percentage of the 8412 kilos of non-fish origin
processed animal proteins that were imported from US into GB in 2011.
Overall, therefore, it is considered there is a __greater than negligible
risk___ that (nonruminant) animal feed and pet food containing deer and/or elk
protein is imported into GB.
There is uncertainty associated with this estimate given the lack of data
on the amount of deer and/or elk protein possibly being imported in these
products.
Friday, December 14, 2012
DEFRA U.K. What is the risk of Chronic Wasting Disease CWD being introduced
into Great Britain? A Qualitative Risk Assessment October 2012
snip...
In the USA, under the Food and Drug Administration’s BSE Feed Regulation
(21 CFR 589.2000) most material (exceptions include milk, tallow, and gelatin)
from deer and elk is prohibited for use in feed for ruminant animals. With
regards to feed for non-ruminant animals, under FDA law, CWD positive deer may
not be used for any animal feed or feed ingredients. For elk and deer considered
at high risk for CWD, the FDA recommends that these animals do not enter the
animal feed system. However, this recommendation is guidance and not a
requirement by law.
Animals considered at high risk for CWD include:
1) animals from areas declared to be endemic for CWD and/or to be CWD
eradication zones and
2) deer and elk that at some time during the 60-month period prior to
slaughter were in a captive herd that contained a CWD-positive animal.
Therefore, in the USA, materials from cervids other than CWD positive
animals may be used in animal feed and feed ingredients for non-ruminants.
The amount of animal PAP that is of deer and/or elk origin imported from
the USA to GB can not be determined, however, as it is not specified in TRACES.
It may constitute a small percentage of the 8412 kilos of non-fish origin
processed animal proteins that were imported from US into GB in 2011.
Overall, therefore, it is considered there is a __greater than negligible
risk___ that (nonruminant) animal feed and pet food containing deer and/or elk
protein is imported into GB.
There is uncertainty associated with this estimate given the lack of data
on the amount of deer and/or elk protein possibly being imported in these
products.
snip...
36% in 2007 (Almberg et al., 2011). In such areas, population declines of
deer of up to 30 to 50% have been observed (Almberg et al., 2011). In areas of
Colorado, the prevalence can be as high as 30% (EFSA, 2011). The clinical signs
of CWD in affected adults are weight loss and behavioural changes that can span
weeks or months (Williams, 2005). In addition, signs might include excessive
salivation, behavioural alterations including a fixed stare and changes in
interaction with other animals in the herd, and an altered stance (Williams,
2005). These signs are indistinguishable from cervids experimentally infected
with bovine spongiform encephalopathy (BSE). Given this, if CWD was to be
introduced into countries with BSE such as GB, for example, infected deer
populations would need to be tested to differentiate if they were infected with
CWD or BSE to minimise the risk of BSE entering the human food-chain via
affected venison.
snip...
The rate of transmission of CWD has been reported to be as high as 30% and
can approach 100% among captive animals in endemic areas (Safar et al., 2008).
snip...
In summary, in endemic areas, there is a medium probability that the soil
and surrounding environment is contaminated with CWD prions and in a
bioavailable form. In rural areas where CWD has not been reported and deer are
present, there is a greater than negligible risk the soil is contaminated with
CWD prion.
snip...
In summary, given the volume of tourists, hunters and servicemen moving
between GB and North America, the probability of at least one person travelling
to/from a CWD affected area and, in doing so, contaminating their clothing,
footwear and/or equipment prior to arriving in GB is greater than negligible.
For deer hunters, specifically, the risk is likely to be greater given the
increased contact with deer and their environment. However, there is significant
uncertainty associated with these estimates.
snip...
Therefore, it is considered that farmed and park deer may have a higher
probability of exposure to CWD transferred to the environment than wild deer
given the restricted habitat range and higher frequency of contact with tourists
and returning GB residents.
snip...
Susceptibility of European Red Deer (Cervus elaphus elaphus) to Alimentary
Challenge with Bovine Spongiform Encephalopathy
Mark P. Dagleish , * E-mail: mark.dagleish@moredun.ac.uk
Affiliation: Moredun Research Institute, Pentlands Science Park, Bush Loan,
Penicuik, Near Edinburgh EH26 0PZ, United Kingdom
⨯ Stuart Martin, Affiliation: Animal Health & Veterinary Laboratories
Agency Lasswade, Pentlands Science Park, Bush Loan, Penicuik, Near Edinburgh
EH26 0PZ, United Kingdom
⨯ Philip Steele, Affiliation: Moredun Research Institute, Pentlands Science
Park, Bush Loan, Penicuik, Near Edinburgh EH26 0PZ, United Kingdom
⨯ Jeanie Finlayson, Affiliation: Moredun Research Institute, Pentlands
Science Park, Bush Loan, Penicuik, Near Edinburgh EH26 0PZ, United Kingdom
⨯ Samantha L. Eaton, Affiliation: Neurobiology Division, The Roslin
Institute at, Royal (Dick) School of Veterinary Studies, University of
Edinburgh, Easter Bush Campus, Midlothian, EH25 9RG, United Kingdom
⨯ Sílvia Sisó, Affiliation: Animal Health & Veterinary Laboratories
Agency Lasswade, Pentlands Science Park, Bush Loan, Penicuik, Near Edinburgh
EH26 0PZ, United Kingdom
⨯ Paula Stewart, Affiliation: Neurobiology Division, The Roslin Institute
at, Royal (Dick) School of Veterinary Studies, University of Edinburgh, Easter
Bush Campus, Midlothian, EH25 9RG, United Kingdom
⨯ Natalia Fernández-Borges, Affiliation: CIC bioGUNE, Parque tecnológico de
Bizkaia, Derio 48160, Spain
⨯ Scott Hamilton, Affiliation: Moredun Research Institute, Pentlands
Science Park, Bush Loan, Penicuik, Near Edinburgh EH26 0PZ, United Kingdom
⨯ Yvonne Pang, Affiliation: Moredun Research Institute, Pentlands Science
Park, Bush Loan, Penicuik, Near Edinburgh EH26 0PZ, United Kingdom
⨯ Francesca Chianini, Affiliation: Moredun Research Institute, Pentlands
Science Park, Bush Loan, Penicuik, Near Edinburgh EH26 0PZ, United Kingdom
⨯ Hugh W. Reid, Affiliation: Moredun Research Institute, Pentlands Science
Park, Bush Loan, Penicuik, Near Edinburgh EH26 0PZ, United Kingdom
⨯ Wilfred Goldmann, Affiliation: Neurobiology Division, The Roslin
Institute at, Royal (Dick) School of Veterinary Studies, University of
Edinburgh, Easter Bush Campus, Midlothian, EH25 9RG, United Kingdom
⨯ Lorenzo González, Affiliation: Animal Health & Veterinary
Laboratories Agency Lasswade, Pentlands Science Park, Bush Loan, Penicuik, Near
Edinburgh EH26 0PZ, United Kingdom
⨯ Joaquín Castilla, Affiliations: CIC bioGUNE, Parque tecnológico de
Bizkaia, Derio 48160, Spain, IKERBASQUE, Basque Foundation for Science, Bilbao
48013, Bizkaia, Spain
⨯ [ ... ], Martin Jeffrey Affiliation: Animal Health & Veterinary
Laboratories Agency Lasswade, Pentlands Science Park, Bush Loan, Penicuik, Near
Edinburgh EH26 0PZ, United Kingdom
⨯ [ view all ] [ view less ] Susceptibility of European Red Deer (Cervus
elaphus elaphus) to Alimentary Challenge with Bovine Spongiform Encephalopathy
Mark P. Dagleish, Stuart Martin, Philip Steele, Jeanie Finlayson, Samantha L.
Eaton, Sílvia Sisó, Paula Stewart, Natalia Fernández-Borges, … Scott Hamilton,
Yvonne Pang PLOS x Published: January 23, 2015 DOI: 10.1371/journal.pone.0116094
Abstract
European red deer (Cervus elaphus elaphus) are susceptible to the agent of
bovine spongiform encephalopathy, one of the transmissible spongiform
encephalopathies, when challenged intracerebrally but their susceptibility to
alimentary challenge, the presumed natural route of transmission, is unknown. To
determine this, eighteen deer were challenged via stomach tube with a large dose
of the bovine spongiform encephalopathy agent and clinical signs, gross and
histological lesions, presence and distribution of abnormal prion protein and
the attack rate recorded. Only a single animal developed clinical disease, and
this was acute with both neurological and respiratory signs, at 1726 days post
challenge although there was significant (27.6%) weight loss in the preceding
141 days. The clinically affected animal had histological lesions of vacuolation
in the neuronal perikaryon and neuropil, typical of transmissible spongiform
encephalopathies. Abnormal prion protein, the diagnostic marker of transmissible
encephalopathies, was primarily restricted to the central and peripheral nervous
systems although a very small amount was present in tingible body macrophages in
the lymphoid patches of the caecum and colon. Serial protein misfolding cyclical
amplification, an in vitro ultra-sensitive diagnostic technique, was positive
for neurological tissue from the single clinically diseased deer. All other
alimentary challenged deer failed to develop clinical disease and were negative
for all other investigations. These findings show that transmission of bovine
spongiform encephalopathy to European red deer via the alimentary route is
possible but the transmission rate is low. Additionally, when deer carcases are
subjected to the same regulations that ruminants in Europe with respect to the
removal of specified offal from the human food chain, the zoonotic risk of
bovine spongiform encephalopathy, the cause of variant Creutzfeldt-Jakob
disease, from consumption of venison is probably very low.
snip...
Discussion This investigation resulted in the first and only known case, to
date, of clinical disease or accumulation of abnormal PrPd in any cervid species
due to oral challenge with BSE. The increase in incubation period compared to
European red deer challenged with BSE intra-cerebrally (1060 days) [33] compared
to oral challenge (1727 days) is approximately 60% and similar to the
differences observed in incubation periods for sheep or goats when challenged
with TSE agents by these two routes [40,41]. The neurological clinical signs
observed could be broadly related to the spongiform encephalopathy and the
accumulation of PrPd in that the restlessness, stereotypic head movements and
pacing may be due to compromise of the nucleus accumbens [42], found in the
striatum, and the laboured breathing due to the lesions in the medulla, where
the respiratory centre is located [43]. Alternatively, the laboured and audible
mouth breathing may have been due to, or contributed to by, compromise of either
of the recurrent laryngeal nerves resulting in some degree of laryngeal
paralysis but we were unable to determine this. Apart from the gradual loss of
body weight, the speed of onset of clinical signs and progression was very rapid
but animal welfare requirements precluded any further longitudinal study of
these. The clinical signs described for this animal are broadly similar to those
reported for clinical BSE in European red deer challenged via the intracerebral
route [33], clinical cases of CWD in deer [44] and clinical cases of BSE in
cattle [45].
snip...see full text ;
31 Jan 2015 at 20:14 GMT
*** Ruminant feed ban for cervids in the United States? ***
31 Jan 2015 at 20:14 GMT
Oral transmission and early lymphoid tropism of chronic wasting disease PrPres in mule deer fawns (Odocoileus hemionus)
The rapid infection of deer fawns following exposure by the most plausible natural route is consistent with the efficient horizontal transmission of CWD in nature and enables accelerated studies of transmission and pathogenesis in the native species. Introduction
http://vir.sgmjournals.org/content/80/10/2757.full.pdf
10,000,000+ LBS. of PROHIBITED BANNED MAD COW FEED I.E. BLOOD LACED MBM IN
COMMERCE USA 2007
Date: March 21, 2007 at 2:27 pm PST
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINES -- CLASS II
PRODUCT
Bulk cattle feed made with recalled Darling's 85% Blood Meal, Flash Dried,
Recall # V-024-2007
CODE
Cattle feed delivered between 01/12/2007 and 01/26/2007
RECALLING FIRM/MANUFACTURER
Pfeiffer, Arno, Inc, Greenbush, WI. by conversation on February 5, 2007.
Firm initiated recall is ongoing.
REASON
Blood meal used to make cattle feed was recalled because it was cross-
contaminated with prohibited bovine meat and bone meal that had been
manufactured on common equipment and labeling did not bear cautionary BSE
statement.
VOLUME OF PRODUCT IN COMMERCE
42,090 lbs.
DISTRIBUTION
WI
___________________________________
PRODUCT
Custom dairy premix products: MNM ALL PURPOSE Pellet, HILLSIDE/CDL Prot-
Buffer Meal, LEE, M.-CLOSE UP PX Pellet, HIGH DESERT/ GHC LACT Meal, TATARKA, M
CUST PROT Meal, SUNRIDGE/CDL PROTEIN Blend, LOURENZO, K PVM DAIRY Meal, DOUBLE B
DAIRY/GHC LAC Mineral, WEST PIONT/GHC CLOSEUP Mineral, WEST POINT/GHC LACT Meal,
JENKS, J/COMPASS PROTEIN Meal, COPPINI - 8# SPECIAL DAIRY Mix, GULICK, L-LACT
Meal (Bulk), TRIPLE J - PROTEIN/LACTATION, ROCK CREEK/GHC MILK Mineral,
BETTENCOURT/GHC S.SIDE MK-MN, BETTENCOURT #1/GHC MILK MINR, V&C DAIRY/GHC
LACT Meal, VEENSTRA, F/GHC LACT Meal, SMUTNY, A- BYPASS ML W/SMARTA, Recall #
V-025-2007
CODE
The firm does not utilize a code - only shipping documentation with
commodity and weights identified.
RECALLING FIRM/MANUFACTURER
Rangen, Inc, Buhl, ID, by letters on February 13 and 14, 2007. Firm
initiated recall is complete.
REASON
Products manufactured from bulk feed containing blood meal that was cross
contaminated with prohibited meat and bone meal and the labeling did not bear
cautionary BSE statement.
VOLUME OF PRODUCT IN COMMERCE
9,997,976 lbs.
DISTRIBUTION
ID and NV
END OF ENFORCEMENT REPORT FOR MARCH 21, 2007
Tuesday, December 23, 2014
FDA PART 589 -- SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED
VIOLATIONS OFFICIAL ACTION INDICATED OAI UPDATE DECEMBER 2014 BSE TSE PRION
2013
Sunday, December 15, 2013
FDA PART 589 -- SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED
VIOLATIONS OFFICIAL ACTION INDICATED OAI UPDATE DECEMBER 2013 UPDATE
DOCKET-- 03D-0186 -- FDA Issues Draft Guidance on Use of Material From Deer
and Elk in Animal Feed; Availability
Date: Fri, 16 May 2003 11:47:37 –0500
EMC 1 Terry S. Singeltary Sr. Vol #: 1
PLEASE SEE FULL TEXT SUBMISSION ;
19 May 2010 at 21:21 GMT
*** Singeltary reply ; Molecular, Biochemical and Genetic Characteristics
of BSE in Canada Singeltary reply ;
Saturday, January 24, 2015
Bovine Spongiform Encephalopathy: Atypical Pros and Cons
Saturday, January 31, 2015
RAPID ADVICE 17-2014 : Evaluation of the risk for public health of casings
in countries with a “negligible risk status for BSE” and on the risk of
modification of the list of specified risk materials (SRM) with regard to BSE
Conclusion/Significance: Our results point to a possibly higher degree of
pathogenicity of BASE than classical BSE in primates and also raise a question
about a possible link to one uncommon subset of cases of apparently sporadic
CJD. Thus, despite the waning epidemic of classical BSE, the occurrence of
atypical strains should temper the urge to relax measures currently in place to
protect public health from accidental contamination by BSE-contaminated
products.
Thursday, March 19, 2015
Detection and Discrimination of Classical and Atypical L-Type Bovine
Spongiform Encephalopathy by Real-Time Quaking-Induced Conversion
Wednesday, March 18, 2015
Changes in Retinal Function and Morphology Are Early Clinical Signs of
Disease in Cattle with Bovine Spongiform Encephalopathy
Thursday, February 19, 2015
Inspections Circumvented for Condemned Cows STATEMENT OF THE HONORABLE
PHYLLIS K. FONG INSPECTOR GENERAL
Tuesday, February 17, 2015
*** Could we spot the next BSE?, asks BVA President
Tuesday, December 16, 2014
Evidence for zoonotic potential of ovine scrapie prions
Hervé Cassard,1, n1 Juan-Maria Torres,2, n1 Caroline Lacroux,1, Jean-Yves
Douet,1, Sylvie L. Benestad,3, Frédéric Lantier,4, Séverine Lugan,1, Isabelle
Lantier,4, Pierrette Costes,1, Naima Aron,1, Fabienne Reine,5, Laetitia
Herzog,5, Juan-Carlos Espinosa,2, Vincent Beringue5, & Olivier Andréoletti1,
Affiliations Contributions Corresponding author Journal name: Nature
Communications Volume: 5, Article number: 5821 DOI: doi:10.1038/ncomms6821
Received 07 August 2014 Accepted 10 November 2014 Published 16 December 2014
Article tools Citation Reprints Rights & permissions Article metrics
Abstract
Although Bovine Spongiform Encephalopathy (BSE) is the cause of variant
Creutzfeldt Jakob disease (vCJD) in humans, the zoonotic potential of scrapie
prions remains unknown. Mice genetically engineered to overexpress the human
prion protein (tgHu) have emerged as highly relevant models for gauging the
capacity of prions to transmit to humans. These models can propagate human
prions without any apparent transmission barrier and have been used used to
confirm the zoonotic ability of BSE. Here we show that a panel of sheep scrapie
prions transmit to several tgHu mice models with an efficiency comparable to
that of cattle BSE. The serial transmission of different scrapie isolates in
these mice led to the propagation of prions that are phenotypically identical to
those causing sporadic CJD (sCJD) in humans. These results demonstrate that
scrapie prions have a zoonotic potential and raise new questions about the
possible link between animal and human prions.
Subject terms: Biological sciences• Medical research At a glance
why do we not want to do TSE transmission studies on chimpanzees $
5. A positive result from a chimpanzee challenged severly would likely
create alarm in some circles even if the result could not be interpreted for
man. I have a view that all these agents could be transmitted provided a large
enough dose by appropriate routes was given and the animals kept long enough.
Until the mechanisms of the species barrier are more clearly understood it might
be best to retain that hypothesis.
snip...
R. BRADLEY
Suspect symptoms
What if you can catch old-fashioned CJD by eating meat from a sheep
infected with scrapie?
28 Mar 01 Most doctors believe that sCJD is caused by a prion protein
deforming by chance into a killer. But Singeltary thinks otherwise. He is one of
a number of campaigners who say that some sCJD, like the variant CJD related to
BSE, is caused by eating meat from infected animals. Their suspicions have
focused on sheep carrying scrapie, a BSE-like disease that is widespread in
flocks across Europe and North America.
Now scientists in France have stumbled across new evidence that adds weight
to the campaigners' fears. To their complete surprise, the researchers found
that one strain of scrapie causes the same brain damage in mice as sCJD.
"This means we cannot rule out that at least some sCJD may be caused by
some strains of scrapie," says team member Jean-Philippe Deslys of the French
Atomic Energy Commission's medical research laboratory in Fontenay-aux-Roses,
south-west of Paris. Hans Kretschmar of the University of Göttingen, who
coordinates CJD surveillance in Germany, is so concerned by the findings that he
now wants to trawl back through past sCJD cases to see if any might have been
caused by eating infected mutton or lamb...
2001
Suspect symptoms
What if you can catch old-fashioned CJD by eating meat from a sheep
infected with scrapie?
28 Mar 01
Like lambs to the slaughter
31 March 2001
by Debora MacKenzie Magazine issue 2284.
FOUR years ago, Terry Singeltary watched his mother die horribly from a
degenerative brain disease. Doctors told him it was Alzheimer's, but Singeltary
was suspicious. The diagnosis didn't fit her violent symptoms, and he demanded
an autopsy. It showed she had died of sporadic Creutzfeldt-Jakob disease.
Most doctors believe that sCJD is caused by a prion protein deforming by
chance into a killer. But Singeltary thinks otherwise. He is one of a number of
campaigners who say that some sCJD, like the variant CJD related to BSE, is
caused by eating meat from infected animals. Their suspicions have focused on
sheep carrying scrapie, a BSE-like disease that is widespread in flocks across
Europe and North America.
Now scientists in France have stumbled across new evidence that adds weight
to the campaigners' fears. To their complete surprise, the researchers found
that one strain of scrapie causes the same brain damage in mice as sCJD.
"This means we cannot rule out that at least some sCJD may be caused by
some strains of scrapie," says team member Jean-Philippe Deslys of the French
Atomic Energy Commission's medical research laboratory in Fontenay-aux-Roses,
south-west of Paris. Hans Kretschmar of the University of Göttingen, who
coordinates CJD surveillance in Germany, is so concerned by the findings that he
now wants to trawl back through past sCJD cases to see if any might have been
caused by eating infected mutton or lamb.
Scrapie has been around for centuries and until now there has been no
evidence that it poses a risk to human health. But if the French finding means
that scrapie can cause sCJD in people, countries around the world may have
overlooked a CJD crisis to rival that caused by BSE.
Deslys and colleagues were originally studying vCJD, not sCJD. They
injected the brains of macaque monkeys with brain from BSE cattle, and from
French and British vCJD patients. The brain damage and clinical symptoms in the
monkeys were the same for all three. Mice injected with the original sets of
brain tissue or with infected monkey brain also developed the same
symptoms.
As a control experiment, the team also injected mice with brain tissue from
people and animals with other prion diseases: a French case of sCJD; a French
patient who caught sCJD from human-derived growth hormone; sheep with a French
strain of scrapie; and mice carrying a prion derived from an American scrapie
strain. As expected, they all affected the brain in a different way from BSE and
vCJD. But while the American strain of scrapie caused different damage from
sCJD, the French strain produced exactly the same pathology.
"The main evidence that scrapie does not affect humans has been
epidemiology," says Moira Bruce of the neuropathogenesis unit of the Institute
for Animal Health in Edinburgh, who was a member of the same team as Deslys.
"You see about the same incidence of the disease everywhere, whether or not
there are many sheep, and in countries such as New Zealand with no scrapie." In
the only previous comparisons of sCJD and scrapie in mice, Bruce found they were
dissimilar.
But there are more than 20 strains of scrapie, and six of sCJD. "You would
not necessarily see a relationship between the two with epidemiology if only
some strains affect only some people," says Deslys. Bruce is cautious about the
mouse results, but agrees they require further investigation. Other trials of
scrapie and sCJD in mice, she says, are in progress.
People can have three different genetic variations of the human prion
protein, and each type of protein can fold up two different ways. Kretschmar has
found that these six combinations correspond to six clinical types of sCJD: each
type of normal prion produces a particular pathology when it spontaneously
deforms to produce sCJD.
But if these proteins deform because of infection with a disease-causing
prion, the relationship between pathology and prion type should be different, as
it is in vCJD. "If we look at brain samples from sporadic CJD cases and find
some that do not fit the pattern," says Kretschmar, "that could mean they were
caused by infection."
There are 250 deaths per year from sCJD in the US, and a similar incidence
elsewhere. Singeltary and other US activists think that some of these people
died after eating contaminated meat or "nutritional" pills containing dried
animal brain. Governments will have a hard time facing activists like Singeltary
if it turns out that some sCJD isn't as spontaneous as doctors have
insisted.
Deslys's work on macaques also provides further proof that the human
disease vCJD is caused by BSE. And the experiments showed that vCJD is much more
virulent to primates than BSE, even when injected into the bloodstream rather
than the brain. This, says Deslys, means that there is an even bigger risk than
we thought that vCJD can be passed from one patient to another through
contaminated blood transfusions and surgical instruments.
Friday, January 30, 2015
*** Scrapie: a particularly persistent pathogen ***
Wednesday, December 24, 2014
National Scrapie Eradication Program November 2014 Monthly Report Fiscal
Year 2015
Wednesday, March 18, 2015
Chronic Wasting Disease CWD Confirmed Texas Trans Pecos March 18,
2015
*** The potential impact of prion diseases on human health was greatly
magnified by the recognition that interspecies transfer of BSE to humans by beef
ingestion resulted in vCJD. While changes in animal feed constituents and
slaughter practices appear to have curtailed vCJD, there is concern that CWD of
free-ranging deer and elk in the U.S. might also cross the species barrier.
Thus, consuming venison could be a source of human prion disease. Whether BSE
and CWD represent interspecies scrapie transfer or are newly arisen prion
diseases is unknown. Therefore, the possibility of transmission of prion disease
through other food animals cannot be ruled out. There is evidence that vCJD can
be transmitted through blood transfusion. There is likely a pool of unknown size
of asymptomatic individuals infected with vCJD, and there may be asymptomatic
individuals infected with the CWD equivalent. These circumstances represent a
potential threat to blood, blood products, and plasma supplies.
Monday, March 09, 2015
*** Chronic Wasting Disease CWD TSE prion and human animal risk factor
there from
Saturday, March 21, 2015
*** Canada and United States Creutzfeldt Jakob TSE Prion Disease Incidence
Rates Increasing ***
COMMENT FROM TERRY S. SINGELTARY SR.
|
This is a Comment on the Animal and Plant Health
Inspection Service (APHIS) Notice: Agency Information
Collection Activities; Proposals, Submissions, and Approvals: Bovine Spongiform
Encephalopathy; Importation of Animals and Animal
Products
For related information, Open Docket Folder
 Comment
Docket No. APHIS-2014-0107
Bovine Spongiform Encephalopathy; Importation of Animals and Animal Products
Singeltary Submission ;
I believe that there is more risk to the world from Transmissible Spongiform Encephalopathy TSE prion aka mad cow type disease now, coming from the United States and all of North America, than there is risk coming to the USA and North America, from other Countries. I am NOT saying I dont think there is any risk for the BSE type TSE prion coming from other Countries, I am just saying that in 2015, why is the APHIS/USDA/FSIS/FDA still ignoring these present mad cow risk factors in North America like they are not here? North America has more strains of TSE prion disease, in more species (excluding zoo animals in the early BSE days, and excluding the Feline TSE and or Canine TSE, because they dont look, and yes, there has been documented evidence and scientific studies, and DEFRA Hound study, that shows the canine spongiform encephalopathy is very possible, if it has not already happened, just not documented), then any other Country in the world. Mink TME, Deer Elk cervid CWD (multiple strains), cBSE cattle, atypical L-type BSE cattle, atypical H-type BSE cattle, atyical HG type BSE cow (the only cow documented in the world to date with this strain), typical sheep goat Scrapie (multiple strains), and the atypical Nor-98 Scrapie, which has been linked to sporadic CJD, Nor-98 atypical Scrapie has spread from coast to coast. sporadic CJD on the rise, with different strains mounting, victims becoming younger, with the latest nvCJD human mad cow case being documented in Texas again, this case, NOT LINKED TO EUROPEAN TRAVEL CDC. typical BSE can propagate as nvCJD and or sporadic CJD (Collinge et al), and sporadic CJD has now been linked to atypical BSE, Scrapie and atypical Scrapie, and scientist are very concerned with CWD TSE prion in the Cervid populations. in my opinion, the BSE MRR policy, which overtook the BSE GBR risk assessments for each country, and then made BSE confirmed countries legal to trade mad cow disease, which was all brought forth AFTER that fateful day December 23, 2003, when the USA lost its gold card i.e. BSE FREE status, thats the day it all started. once the BSE MRR policy was shoved down every countries throat by USDA inc and the OIE, then the legal trading of Scrapie was validated to be a legal trading commodity, also shoved through by the USDA inc and the OIE, the world then lost 30 years of attempted eradication of the BSE TSE prion disease typical and atypical strains, and the BSE TSE Prion aka mad cow type disease was thus made a legal trading commodity, like it or not. its all about money now folks, trade, to hell with human health with a slow incubating disease, that is 100% fatal once clinical, and forget the fact of exposure, sub-clinical infection, and friendly fire there from i.e. iatrogenic TSE prion disease, the pass it forward mode of the TSE PRION aka mad cow type disease. its all going to be sporadic CJD or sporadic ffi, or sporadic gss, or now the infamous VPSPr. ...problem solved $$$ the USDA/APHIS/FSIS/FDA triple mad cow BSE firewall, well, that was nothing but ink on paper. for this very reason I believe the BSE MRR policy is a total failure, and that this policy should be immediately withdrawn, and set back in place the BSE GBR Risk Assessments, with the BSE GBR risk assessments set up to monitor all TSE PRION disease in all species of animals, and that the BSE GBR risk assessments be made stronger than before. lets start with the recent notice that beef from Ireland will be coming to America. Ireland confirmed around 1655 cases of mad cow disease. with the highest year confirming about 333 cases in 2002, with numbers of BSE confirmed cases dropping from that point on, to a documentation of 1 confirmed case in 2013, to date. a drastic decrease in the feeding of cows to cows i.e. the ruminant mad cow feed ban, and the enforcement of that ban, has drastically reduced the number of BSE cases in Europe, minus a few BABs or BARBs. a far cry from the USDA FDA triple BSE firewall, which was nothing more than ink on paper, where in 2007, in one week recall alone, some 10 MILLION POUNDS OF BANNED POTENTIAL MAD COW FEED WENT OUT INTO COMMERCE IN THE USA. this is 10 years post feed ban. in my honest opinion, due to the blatant cover up of BSE TSE prion aka mad cow disease in the USA, we still have no clue as to the true number of cases of BSE mad cow disease in the USA or North America as a whole. ...just saying. Number of reported cases of bovine spongiform encephalopathy (BSE) in farmed cattle worldwide* (excluding the United Kingdom) Country/Year snip...please see attached pdf file, with references of breaches in the USA triple BSE mad cow firewalls, and recent science on the TSE prion disease. ...TSS Attachments(1)Docket No. APHIS-2014-0107 Bovine Spongiform Encephalopathy; Importation of Animals and Animal Products Singeltary Submission
View
Attachment:
 |
Sunday, January 11, 2015
Docket No. APHIS-2014-0107 Bovine Spongiform Encephalopathy; Importation of
Animals and Animal Products Singeltary Submission
Saturday, March 21, 2015
*** Canada and United States Creutzfeldt Jakob TSE Prion Disease Incidence
Rates Increasing ***
Terry S. Singeltary Sr.
Your comment was submitted successfully!.
Success! You will now be commenting directly on:
The Food and Drug Administration (FDA) Notice: Draft Guidance for Industry
on Ensuring Safety of Animal Feed Maintained and Fed On-Farm; Availability
For related information, Open Docket Folder Docket folder icon
3.Your Receipt.3 Your Receipt 2 Your Preview 1 Your Information ..publicly
viewable Information entered will be viewable on Regulations.gov Agency Posting
Guidelines: More infoView Commenter's Checklist (PDF) Alternate Ways to Comment
.Comment(Required) publicly viewable http://www.regulations.gov/#!documentDetail;D=FDA-2014-D-1180-0001
Guidance for Industry Ensuring Safety of Animal Feed Maintained and Fed
On-Farm Draft Guidance FDA-2014-D-1180 Singeltary Comment
Greetings FDA et al,
I wish to comment on Guidance for Industry Ensuring Safety of Animal Feed
Maintained and Fed On-Farm Draft Guidance FDA-2014-D-1180.
Once again, I wish to kindly bring up the failed attempt of the FDA and the
ruminant to ruminant mad cow feed ban of August 4, 1997. This feed ban is still
failing today, as we speak. Even more worrisome, is the fact it is still legal
to feed cervids to cervids in the USA, in fact, the FDA only _recommends_ that
deer and elk considered to be of _high_ risk for CWD do not enter the animal
food chain, but there is NO law, it’s only voluntary, a recipe for a TSE prion
disaster, as we have seen with the ruminant to ruminant feed ban for cattle,
where in 2007, one decade post August 1997 mad cow feed ban, where in 2007
10,000,000 POUNDS OF BANNED BLOOD LACED MEAT AND BONE MEAL WHEN OUT INTO
COMMERCE, TO BE FED OUT. Since 2007, these BSE feed ban rules have been breached
time and time again. tons and tons of mad cow feed went out in Alabama as well,
where one of the mad cows were documented, just the year before in 2006, and in
2013 and 2014, breaches so bad (OAI) Official Action Indicated were issued.
those are like the one issued where 10 million pounds of banned blood laced meat
and bone meal were fed out.
What is the use of having a ‘Guidance for Industry Ensuring Safety of
Animal Feed Maintained and Fed On-Farm Draft Guidance FDA-2014-D-1180’, if it
cannot be enforced, as we have seen with a mandatory ruminant to ruminant feed
ban?
I strenuously once again urge the FDA and it’s industry constituents, to
make it MANDATORY that all ruminant feed be banned to all ruminants, and this
should include all cervids as soon as possible for the following reasons...
======
In the USA, under the Food and Drug Administration’s BSE Feed Regulation
(21 CFR 589.2000) most material (exceptions include milk, tallow, and gelatin)
from deer and elk is prohibited for use in feed for ruminant animals. With
regards to feed for non-ruminant animals, under FDA law, CWD positive deer may
not be used for any animal feed or feed ingredients. For elk and deer considered
at high risk for CWD, the FDA recommends that these animals do not enter the
animal feed system.
***However, this recommendation is guidance and not a requirement by law.
======
31 Jan 2015 at 20:14 GMT
*** Ruminant feed ban for cervids in the United States? ***
31 Jan 2015 at 20:14 GMT
19 May 2010 at 21:21 GMT
*** Singeltary reply ; Molecular, Biochemical and Genetic Characteristics
of BSE in Canada Singeltary reply ;
Tuesday, December 23, 2014
FDA PART 589 -- SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED
VIOLATIONS OFFICIAL ACTION INDICATED OAI UPDATE DECEMBER 2014 BSE TSE PRION
2013
Sunday, December 15, 2013
FDA PART 589 -- SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED
VIOLATIONS OFFICIAL ACTION INDICATED OAI UPDATE DECEMBER 2013 UPDATE
http://madcowusda.blogspot.com/2013/12/fda-part-589-substances-prohibited-from.html
DOCKET-- 03D-0186 -- FDA Issues Draft Guidance on Use of Material From Deer and
Elk in Animal Feed; Availability Date: Fri, 16 May 2003 11:47:37 –0500 EMC 1
Terry S. Singeltary Sr. Vol #: 1
PLEASE SEE FULL TEXT SUBMISSION ;
10,000,000+ LBS. of PROHIBITED BANNED MAD COW FEED I.E. BLOOD LACED MBM IN
COMMERCE USA 2007
Date: March 21, 2007 at 2:27 pm PST
REASON
Blood meal used to make cattle feed was recalled because it was cross-
contaminated with prohibited bovine meat and bone meal that had been
manufactured on common equipment and labeling did not bear cautionary BSE
statement.
VOLUME OF PRODUCT IN COMMERCE
42,090 lbs.
DISTRIBUTION
WI
REASON
Products manufactured from bulk feed containing blood meal that was cross
contaminated with prohibited meat and bone meal and the labeling did not bear
cautionary BSE statement.
VOLUME OF PRODUCT IN COMMERCE
9,997,976 lbs.
DISTRIBUTION
ID and NV
END OF ENFORCEMENT REPORT FOR MARCH 21, 2007
Terry S. Singeltary Sr.
*** See attached file(s).Only 1 character remaining...Drop files hereUpload
file(s)(Optional)publicly viewableChoose fileProcessing dropped files...Guidance
for Indust...ry Comment.txtCancelRetryDeleteDrop files here..First
Name(Required) publicly viewable .. Last Name(Required) publicly viewable ...I
want to provide my contact information OpenContact Information.(Required)
publicly viewable .. (Required) publicly viewable ....(Required) publicly
viewable .. State or Province(Required) publicly viewable ....Region(Required)
publicly viewable ..ZIP/Postal Code(Required) publicly viewable
....Country(Required) publicly viewable ......Email Address(Required) publicly
viewable .. (Required) publicly viewable ..(Required) publicly viewable ... I am
submitting on behalf of a third party OpenRepresenting Another.Submitter's
Representative(Required) publicly viewable .. Organization Name(Required)
publicly viewable ....(Required) publicly viewable ....(Required) publicly
viewable ....(Required) publicly viewable .... (Required) publicly viewable
....Government agency(Required) publicly viewable ... .Category(Required)
publicly viewable .....ContinueThis is how your comment will appear on
Regulations.gov:Comment: http://www.regulations.gov/#!documentDetail;D=FDA-2014-D-1180-0001
Guidance for Industry Ensuring Safety of Animal Feed Maintained and Fed
On-Farm Draft Guidance FDA-2014-D-1180 Singeltary Comment
Greetings FDA et al,
I wish to comment on Guidance for Industry Ensuring Safety of Animal Feed
Maintained and Fed On-Farm Draft Guidance FDA-2014-D-1180.
Once again, I wish to kindly bring up the failed attempt of the FDA and the
ruminant to ruminant mad cow feed ban of August 4, 1997. This feed ban is still
failing today, as we speak. Even more worrisome, is the fact it is still legal
to feed cervids to cervids in the USA, in fact, the FDA only _recommends_ that
deer and elk considered to be of _high_ risk for CWD do not enter the animal
food chain, but there is NO law, it’s only voluntary, a recipe for a TSE prion
disaster, as we have seen with the ruminant to ruminant feed ban for cattle,
where in 2007, one decade post August 1997 mad cow feed ban, where in 2007
10,000,000 POUNDS OF BANNED BLOOD LACED MEAT AND BONE MEAL WHEN OUT INTO
COMMERCE, TO BE FED OUT. Since 2007, these BSE feed ban rules have been breached
time and time again. tons and tons of mad cow feed went out in Alabama as well,
where one of the mad cows were documented, just the year before in 2006, and in
2013 and 2014, breaches so bad (OAI) Official Action Indicated were issued.
those are like the one issued where 10 million pounds of banned blood laced meat
and bone meal were fed out.
What is the use of having a ‘Guidance for Industry Ensuring Safety of
Animal Feed Maintained and Fed On-Farm Draft Guidance FDA-2014-D-1180’, if it
cannot be enforced, as we have seen with a mandatory ruminant to ruminant feed
ban?
I strenuously once again urge the FDA and it’s industry constituents, to
make it MANDATORY that all ruminant feed be banned to all ruminants, and this
should include all cervids as soon as possible for the following
reasons...
======
In the USA, under the Food and Drug Administration’s BSE Feed Regulation
(21 CFR 589.2000) most material (exceptions include milk, tallow, and gelatin)
from deer and elk is prohibited for use in feed for ruminant animals. With
regards to feed for non-ruminant animals, under FDA law, CWD positive deer may
not be used for any animal feed or feed ingredients. For elk and deer considered
at high risk for CWD, the FDA recommends that these animals do not enter the
animal feed system.
***However, this recommendation is guidance and not a requirement by law.
======
31 Jan 2015 at 20:14 GMT
*** Ruminant feed ban for cervids in the United States? ***
31 Jan 2015 at 20:14 GMT
19 May 2010 at 21:21 GMT
*** Singeltary reply ; Molecular, Biochemical and Genetic Characteristics
of BSE in Canada Singeltary reply ;
Tuesday, December 23, 2014
FDA PART 589 -- SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED
VIOLATIONS OFFICIAL ACTION INDICATED OAI UPDATE DECEMBER 2014 BSE TSE PRION
2013
Sunday, December 15, 2013
FDA PART 589 -- SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED
VIOLATIONS OFFICIAL ACTION INDICATED OAI UPDATE DECEMBER 2013 UPDATE
DOCKET-- 03D-0186 -- FDA Issues Draft Guidance on Use of Material From Deer
and Elk in Animal Feed; Availability Date: Fri, 16 May 2003 11:47:37 –0500 EMC 1
Terry S. Singeltary Sr. Vol #: 1
PLEASE SEE FULL TEXT SUBMISSION ;
10,000,000+ LBS. of PROHIBITED BANNED MAD COW FEED I.E. BLOOD LACED MBM IN
COMMERCE USA 2007
Date: March 21, 2007 at 2:27 pm PST
REASON
Blood meal used to make cattle feed was recalled because it was cross-
contaminated with prohibited bovine meat and bone meal that had been
manufactured on common equipment and labeling did not bear cautionary BSE
statement.
VOLUME OF PRODUCT IN COMMERCE
42,090 lbs.
DISTRIBUTION
WI
REASON
Products manufactured from bulk feed containing blood meal that was cross
contaminated with prohibited meat and bone meal and the labeling did not bear
cautionary BSE statement.
VOLUME OF PRODUCT IN COMMERCE
9,997,976 lbs.
DISTRIBUTION
ID and NV
END OF ENFORCEMENT REPORT FOR MARCH 21, 2007
Terry S. Singeltary Sr.
*** See attached file(s)1 characters remaining Uploaded File(s)(Optional)No
files uploaded•Guidance for Industry Ensuring Safety of Animal Feed Maintained
and Fed On-Farm Draft Guidance FDA-2014-D-1180 Singeltary Comment.txt.This
information will be sent to the agency: This information will appear on
Regulations.gov:None of the information will be displayed on
Regulations.govCategory: Individual Consumer This information will not appear on
Regulations.gov:All information will be displayed on Regulations.govFirst Name:
TerryLast Name: SingeltaryOrganization Name: NA . You are filing a document into
an official docket. Any personal information included in your comment and/or
uploaded attachment(s) may be publicly viewable on the web. I read and
understand the statement above. .EditSubmit Comment. Your Comment Tracking
Number: xxxxx Your comment may be viewable on Regulations.gov once the
agency has reviewed it. This process is dependent on agency public submission
policies/procedures and processing times. Use your tracking number to find out
the status of your comment. Note: You submitted your comment to an agency that
does not publish comments on Regulations.gov. To check the status of your
comment or obtain further information, please follow-up directly with the agency
contact listed in the document soliciting your input. Email ReceiptTool Tip
Success Your email receipt was sent successfully Your comment: Comment:
Guidance for Industry Ensuring Safety of Animal Feed Maintained and Fed
On-Farm Draft Guidance FDA-2014-D-1180 Singeltary Comment
Greetings FDA et al,
I wish to comment on Guidance for Industry Ensuring Safety of Animal Feed
Maintained and Fed On-Farm Draft Guidance FDA-2014-D-1180.
Once again, I wish to kindly bring up the failed attempt of the FDA and the
ruminant to ruminant mad cow feed ban of August 4, 1997. This feed ban is still
failing today, as we speak. Even more worrisome, is the fact it is still legal
to feed cervids to cervids in the USA, in fact, the FDA only _recommends_ that
deer and elk considered to be of _high_ risk for CWD do not enter the animal
food chain, but there is NO law, it’s only voluntary, a recipe for a TSE prion
disaster, as we have seen with the ruminant to ruminant feed ban for cattle,
where in 2007, one decade post August 1997 mad cow feed ban, where in 2007
10,000,000 POUNDS OF BANNED BLOOD LACED MEAT AND BONE MEAL WHEN OUT INTO
COMMERCE, TO BE FED OUT. Since 2007, these BSE feed ban rules have been breached
time and time again. tons and tons of mad cow feed went out in Alabama as well,
where one of the mad cows were documented, just the year before in 2006, and in
2013 and 2014, breaches so bad (OAI) Official Action Indicated were issued.
those are like the one issued where 10 million pounds of banned blood laced meat
and bone meal were fed out.
What is the use of having a ‘Guidance for Industry Ensuring Safety of
Animal Feed Maintained and Fed On-Farm Draft Guidance FDA-2014-D-1180’, if it
cannot be enforced, as we have seen with a mandatory ruminant to ruminant feed
ban?
I strenuously once again urge the FDA and it’s industry constituents, to
make it MANDATORY that all ruminant feed be banned to all ruminants, and this
should include all cervids as soon as possible for the following
reasons...
======
In the USA, under the Food and Drug Administration’s BSE Feed Regulation
(21 CFR 589.2000) most material (exceptions include milk, tallow, and gelatin)
from deer and elk is prohibited for use in feed for ruminant animals. With
regards to feed for non-ruminant animals, under FDA law, CWD positive deer may
not be used for any animal feed or feed ingredients. For elk and deer considered
at high risk for CWD, the FDA recommends that these animals do not enter the
animal feed system.
***However, this recommendation is guidance and not a requirement by law.
======
31 Jan 2015 at 20:14 GMT
*** Ruminant feed ban for cervids in the United States? ***
31 Jan 2015 at 20:14 GMT
19 May 2010 at 21:21 GMT
*** Singeltary reply ; Molecular, Biochemical and Genetic Characteristics
of BSE in Canada Singeltary reply ;
Tuesday, December 23, 2014
FDA PART 589 -- SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED
VIOLATIONS OFFICIAL ACTION INDICATED OAI UPDATE DECEMBER 2014 BSE TSE PRION
2013
Sunday, December 15, 2013
FDA PART 589 -- SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED
VIOLATIONS OFFICIAL ACTION INDICATED OAI UPDATE DECEMBER 2013 UPDATE
DOCKET-- 03D-0186 -- FDA Issues Draft Guidance on Use of Material From Deer
and Elk in Animal Feed; Availability Date: Fri, 16 May 2003 11:47:37 –0500 EMC 1
Terry S. Singeltary Sr. Vol #: 1
PLEASE SEE FULL TEXT SUBMISSION ;
10,000,000+ LBS. of PROHIBITED BANNED MAD COW FEED I.E. BLOOD LACED MBM IN
COMMERCE USA 2007
Date: March 21, 2007 at 2:27 pm PST
REASON
Blood meal used to make cattle feed was recalled because it was cross-
contaminated with prohibited bovine meat and bone meal that had been
manufactured on common equipment and labeling did not bear cautionary BSE
statement.
VOLUME OF PRODUCT IN COMMERCE
42,090 lbs.
DISTRIBUTION
WI
REASON
Products manufactured from bulk feed containing blood meal that was cross
contaminated with prohibited meat and bone meal and the labeling did not bear
cautionary BSE statement.
VOLUME OF PRODUCT IN COMMERCE
9,997,976 lbs.
DISTRIBUTION
ID and NV
END OF ENFORCEMENT REPORT FOR MARCH 21, 2007
Terry S. Singeltary Sr.
*** See attached file(s) 1 characters remaining
Uploaded File(s)(Optional) No files uploaded •Guidance for Industry
Ensuring Safety of Animal Feed Maintained and Fed On-Farm Draft Guidance
FDA-2014-D-1180 Singeltary Comment.txt: success .This information was sent to
the agency: This information will appear on Regulations.gov: None of the
information will be displayed on Regulations.gov Category: Individual Consumer
This information will not appear on Regulations.gov: All information will be
displayed on Regulations.gov First Name: Terry Last Name: Singeltary
Organization Name: NA
Your comment was submitted successfully!.
Success! You will now be commenting directly on:
The Food and Drug Administration (FDA) Notice: Draft Guidance for Industry
on Ensuring Safety of Animal Feed Maintained and Fed On-Farm; Availability
For related information, Open Docket Folder Docket folder icon
3.Your Receipt.3 Your Receipt 2 Your Preview 1 Your Information ..publicly
viewable Information entered will be viewable on Regulations.gov Agency Posting
Guidelines: More infoView Commenter's Checklist (PDF) Alternate Ways to Comment
.Comment(Required) publicly viewable http://www.regulations.gov/#!documentDetail;D=FDA-2014-D-1180-0001
