Tuesday, April 19, 2016

Docket No. FDA-2013-N-0764 for Animal Feed Regulatory Program Standards Singeltary Comment Submission

Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Feed Regulatory Program Standards A Notice by the Food and Drug Administration on 04/12/2016

https://www.federalregister.gov/articles/2016/04/12/2016-08331/agency-information-collection-activities-proposed-collection-comment-request-animal-feed-regulatory#open-comment


https://www.gpo.gov/fdsys/pkg/FR-2016-04-12/pdf/2016-08331.pdf




Docket No. FDA-2013-N-0764 for “Animal Feed Regulatory Program Standards.” Singeltary Comment,
 
Greetings FDA et al,
 
I would kindly like to comment on ;
 
Docket No. FDA-2013-N-0764 for “Animal Feed Regulatory Program Standards.”
 
I implore that we close the mad cow feed loopholes with cervid, and we must enforce existing feed regulations against the BSE TSE Prion. we have failed terribly in this.
 
the august 1997 mad cow feed ban was nothing but ink on paper, imo. please see ;
 
31 Jan 2015 at 20:14 GMT
 
*** Ruminant feed ban for cervids in the United States? ***
 
31 Jan 2015 at 20:14 GMT
 
see Singeltary comment ;
 
 
SEE WHAT DEFRA MAFF ET AL SAID JUST LAST MONTH ABOUT THIS ;
 
Thursday, April 07, 2016
 
What is the risk of chronic wasting disease being introduced into Great Britain? An updated Qualitative Risk Assessment March 2016
 
Sheep and cattle may be exposed to CWD via common grazing areas with affected deer but so far, appear to be poorly susceptible to mule deer CWD (Sigurdson, 2008).
 
***In contrast, cattle are highly susceptible to white-tailed deer CWD and mule deer CWD in experimental conditions but no natural CWD infections in cattle have been reported (Sigurdson, 2008; Hamir et al., 2006). It is not known how susceptible humans are to CWD but given that the prion can be present in muscle, it is likely that humans have been exposed to the agent via consumption of venison (Sigurdson, 2008). Initial experimental research, however, suggests that human susceptibility to CWD is low and there may be a robust species barrier for CWD transmission to humans (Sigurdson, 2008). It is apparent, though, that CWD is affecting wild and farmed cervid populations in endemic areas with some deer populations decreasing as a result.
 
snip...
 
For the purpose of the qualitative risk assessment developed here it is necessary to estimate the probability that a 30-ml bottle of lure contains urine from an infected deer. This requires an estimate of the proportion of deer herds in the USA which are infected with CWD together with the within herd prevalence.
 
The distribution map of CWD in US shows it is present mainly in central states (Figure 1). However, Virginia in the east of the country has recorded seven recent cases of CWD (Anon 2015a). Some US manufacturers claim to take steps to prevent urine being taken from infected animals eg by sourcing from farms where the deer are randomly tested for CWD (Anon 2015a). However, if disease is already present and testing is not carried out regularly, captive populations are not necessarily disease free (Strausser 2014). Urine-based deer lures have been known to be collected from domestic white-tailed deer herds and therefore there is a recognised risk. This is reflected by 6 US States which have
 
14
 
banned the use of natural deer urine for lures, as the deer urine may be sourced from CWD-endemic areas in the USA as well as from areas free of CWD. For example, the US State of Virginia is banning the use of urine-based deer lures on July 2015 and Vermont from 2016 due to the risk of spread of CWD. Alaska banned their use in 2012 (Anon 2015a). Pennsylvania Game Commission has banned urine-based deer lures and acknowledged that there is no way to detect their use (Strausser 2014). On the basis of unpublished data (J. Manson, Pers. Comm.) it appears that up to 50% of deer herds can be infected with 80-90% of animals infected within some herds.
 
*** It is therefore assumed that probability that a 30-ml bottle of deer urine lure imported from the USA is sources from an infected deer is medium.
 
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 cannot be determined, however, as it is not specified in TRACES. It may constitute a small percentage of the very low tonnage of non-fish origin processed animal proteins that were imported from US into GB.
 
*** Overall, therefore, it is considered there is a greater than negligible risk that (non-ruminant) 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...
 
 
Summary and MORE HERE ;
 
What is the risk of chronic wasting disease being introduced into Great Britain? An updated Qualitative Risk Assessment March 2016
 
 
 10 years post mad cow feed ban August 1997
 
 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
 
 
 16 years post mad cow feed ban August 1997
 
 2013
 
 Sunday, December 15, 2013
 
 FDA PART 589 -- SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED VIOLATIONS OFFICIAL ACTION INDICATED OIA UPDATE DECEMBER 2013 UPDATE
 
 
 17 years post mad cow feed ban August 1997
 
 Monday, October 26, 2015
 
 FDA PART 589 -- SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED VIOLATIONS OFFICIAL ACTION INDICATED OIA UPDATE October 2015
 
 
 Tuesday, December 23, 2014
 
 FDA PART 589 -- SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEEDVIOLATIONS OFFICIAL ACTION INDICATED OAI UPDATE DECEMBER 2014 BSE TSE PRION
 
 
 2006 WAS A BANNER YEARS TOO FOR MAD COW PROTEIN IN COMMERCE IN USA. ...SNIP...END
 
 Subject: Re: TEXAS CONFIRMATION OF BOVINE SPONGIFORM ENCEPHALOPATHY BSE TSE PRION IN ONE SAMPLE OF SORGHUM DDGS OUT OF 168 DG SAMPLES
 
 ***UDATED CORRECTION BY AUTHOR...SEE EMAIL TO ME...terry
 
 From: Kyung-Min Lee Sent: Thursday, October 01, 2015 1:39 PM
 
 To: Terry S. Singeltary Sr. ; BSE-L@LISTS.AEGEE.ORG
 
 Cc: CJD-L@LISTS.AEGEE.ORG ; cjdvoice@yahoogroups.com ; bloodcjd@yahoogroups.com ; jcattanach@foodprotection.org ; cnc3@psu.edu ; dloynachan@foodprotection.org ; lhovey@foodprotection.org ; Timothy J. Herrman
 
 Subject: RE: TEXAS CONFIRMATION OF BOVINE SPONGIFORM ENCEPHALOPATHY BSE TSE PRION IN ONE SAMPLE OF SORGHUM DDGS OUT OF 168 DG SAMPLES
 
 Dear Terry S. Singeltary Sr.
 
 Thank for your interest and concern about our published article entitled “Evaluation of Selected Nutrients and Contaminants in Distillers Grains from Ethanol Production in Texas”. I should apologize you and others that there were some errors and misleading statements in this article due to inappropriate terminology. The statement you were concerned about was corrected to "One sorghum DDGS out of 168 DG samples was contaminated with animal protein prohibited for use in ruminant feed and was channeled to poultry feed." We requested the journal editor to correct some errors and the relevant statements, or to withdraw the article from the journal.
 
Again I sincerely apologize for any confusion and inconvenience this may cause. Thanks.
 
best wishes,
 
Kyung-Min
 
Kyung-Min Lee, Ph. D. Research Scientist Office of the Texas State Chemist
 
Texas A&M AgriLife Research P.O. Box 3160, College Station, TX 77841-3160 Phone: 979-845-4113 (ext 132) Email:kml@otsc.tamu.edu Fax: 979-845-1389
 
snip...end...tss
 
my link corrected
 
Sunday, September 27, 2015
 
TEXAS CONFIRMATION OF BOVINE SPONGIFORM ENCEPHALOPATHY BSE TSE PRION IN ONE SAMPLE OF SORGHUM DDGS OUT OF 168 DG SAMPLES
 
 
 
Thursday, March 24, 2016
 
FRANCE CONFIRMS BOVINE SPONGIFORM ENCEPHALOPATHY BSE MAD COW (ESB) chez une vache dans les Ardennes
 
 
Sunday, October 5, 2014
 
France stops BSE testing for Mad Cow Disease
 
 
***atypical spontaneous BSE in France LOL***
 
FRANCE STOPS TESTING FOR MAD COW DISEASE BSE, and here’s why, to many spontaneous events of mad cow disease $$$
 
If you Compare France to other Countries with atypical BSE, in my opinion, you cannot explain this with ‘spontaneous’.
 
Table 1: Number of Atypical BSE cases reported by EU Member States in the period 2001–2014 by country and by type (L- and H-BSE) (extracted from EU BSE databases on 1 July 2014). By 2015, these data might be more comprehensive following a request from the European Commission to Member States for re-testing and retrospective classification of all positive bovine isolates in the EU in the years 2003–2009
 
BSE type
 
Country 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013(a) 2014(a) Total
 
H-BSE Austria 1 1
 
France(b) 1 2 3 1 2 2 2 2 15
 
Germany 1 1 2
 
Ireland 1 1 2 1 5
 
The Netherlands 1 1
 
Poland 1 1 2
 
Portugal 1 1
 
Spain 1 1 2
 
Sweden 1 1
 
United Kingdom 1 1 1 1 1 5
 
Total 2 3 3 1 1 2 2 2 4 4 5 1 4 1 35
 
L-BSE Austria 1 1 2
 
Denmark 1 1
 
France(b) 1 1 1 1 2 1 3 2 1 1 14
 
Germany 1 1 2
 
Italy 1 1 1 1 1 5
 
The Netherlands 1 1 1 3
 
Poland 1 2 2 1 2 1 2 1 12
 
Spain 2 2
 
United Kingdom 1 1 1 1 4
 
Total 0 5 3 4 3 3 6 3 3 4 3 6 1 1 45
 
Total Atypical cases (H + L)
 
2 8 6 5 4 5 8 5 7 8 8 7 5 2 80
 
(a): Data for 2013-2014 are incomplete and may not include all cases/countries reported.
 
(b): France has performed extensive retrospective testing to classify BSE cases, which is probably the explanation for the higher number of Atypical BSE cases reported in this country.
 
The number of Atypical BSE cases detected in countries that have already identified them seems to be similar from year to year. In France, a retrospective study of all TSE-positive cattle identified through the compulsory EU surveillance between 2001 and 2007 indicated that the prevalence of H-BSE and L-BSE was 0.35 and 0.41 cases per million adult cattle tested, respectively, which increased to 1.9 and 1.7 cases per million, respectively, in tested animals over eight years old (Biacabe et al., 2008). No comprehensive study on the prevalence of Atypical BSE cases has yet been carried out in other EU Member States. All cases of Atypical BSE reported in the EU BSE databases have been identified by active surveillance testing (59 % in fallen stock, 38 % in healthy slaughtered cattle and 4 % in emergency slaughtered cattle). Cases were reported in animals over eight years of age, with the exception of two cases (one H-BSE and one L-BSE) detected in Spain in 2011/2012. One additional case of H-BSE was detected in Switzerland in 2012 in a cow born in Germany in 2005 (Guldimann et al., 2012).
 
 
 
Wednesday, July 15, 2015
 
Additional BSE TSE prion testing detects pathologic lesion in unusual brain location and PrPsc by PMCA only, how many cases have we missed?
 
 
***however in 1 C-type challenged animal, Prion 2015 Poster Abstracts S67 PrPsc was not detected using rapid tests for BSE.
 
***Subsequent testing resulted in the detection of pathologic lesion in unusual brain location and PrPsc detection by PMCA only.
 
*** IBNC Tauopathy or TSE Prion disease, it appears, no one is sure ***
 
Posted by Terry S. Singeltary Sr. on 03 Jul 2015 at 16:53 GMT
 
 
*** Singeltary reply ; Molecular, Biochemical and Genetic Characteristics of BSE in Canada Singeltary reply ;
 
 
*** It also suggests a similar cause or source for atypical BSE in these countries. ***
 
Discussion: The C, L and H type BSE cases in Canada exhibit molecular characteristics similar to those described for classical and atypical BSE cases from Europe and Japan.
 
*** This supports the theory that the importation of BSE contaminated feedstuff is the source of C-type BSE in Canada.
 
*** It also suggests a similar cause or source for atypical BSE in these countries. ***
 
see page 176 of 201 pages...tss
 
 
Evidence That Transmissible Mink Encephalopathy Results from Feeding Infected Cattle
 
Over the next 8-10 weeks, approximately 40% of all the adult mink on the farm died from TME.
 
snip...
 
The rancher was a ''dead stock'' feeder using mostly (>95%) downer or dead dairy cattle...
 
 
SEE THE DRASTIC REDUCTION OF CONFIRMED BSE CASES IN THE UK ONCE THE FEED BAN TOOK HOLD FROM THE TOP YEAR DOWN TO THE FIRST ZERO YEAR ;
 
1992 36680 SLAUGHTERED SUSPECTS IN WHICH BSE CONFIRMED
 
2013 0 0 0 0 0 0 0 0
 
 
 
 
 
 
Saturday, April 16, 2016
 
APHIS [Docket No. APHIS-2016-0029] Secretary's Advisory Committee on Animal Health; Meeting May 2, 2016, and June 16, 2016 Singeltary Submission
 
 
Sunday, March 20, 2016
 
UPDATED MARCH 2016 URGENT Docket No. FDA-2003-D-0432 (formerly 03D-0186) Use of Material from Deer and Elk in Animal Feed Singeltary Submission
 
 
Tuesday, April 12, 2016
 
The first detection of Chronic Wasting Disease (CWD) in Europe
 
 
Friday, April 08, 2016
 
Arkansas AGFC Chronic Wasting Disease CWD TSE Prion Confirms 23 Additional Cases Total At 79 To Date
 
 
Saturday, April 02, 2016
 
TEXAS TAHC BREAKS IT'S SILENCE WITH TWO MORE CASES CWD CAPTIVE DEER BRINGING TOTAL TO 10 CAPTIVES REPORTED TO DATE
 
 
Friday, February 26, 2016
 
TEXAS Hartley County Mule Deer Tests Positive for Chronic Wasting Disease CWD TSE Prion
 
 
Friday, February 05, 2016
 
TEXAS NEW CHRONIC WASTING DISEASE CWD CASE DISCOVERD AT CAPTIVE DEER RELEASE SITE
 
 
Thursday, March 31, 2016
 
*** Chronic Wasting Disease CWD TSE Prion Roundup USA April 1, 2016 ***
 
 
Monday, March 28, 2016
 
National Scrapie Eradication Program February 2016 Monthly Report
 
 
*** Docket No. APHIS-2007-0127 Scrapie in Sheep and Goats Terry Singeltary Sr. Submission ***
 
Monday, November 16, 2015
 
*** Docket No. APHIS-2007-0127 Scrapie in Sheep and Goats Terry Singeltary Sr. Submission ***
 
 
 
Friday, March 18, 2016 CFSAN
 
Constituent Update: FDA Announces Final Rule on Bovine Spongiform Encephalopathy BSE MAD COW TSE PRION Center for Food Safety and Applied Nutrition - Constituent Update
 
 
Tuesday, March 15, 2016
 
Docket No. FDA-2016-N-0321 Risk Assessment of Foodborne Illness Associated with Pathogens from Produce Grown in Fields Amended with Untreated Biological Soil Amendments of Animal Origin; Request for Comments, Scientific Data, and Information Singeltary Submission
 
 
Monday, April 11, 2016
 
DECLARATION OF EXTRAORDINARY EMERGENCY DUE TO A FOREIGN ANIMAL DISEASE TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY TSE PRION CHRONIC WASTING DISEASE CWD IN THE UNITED STATES AND NORTH AMERICA ?
 
 
Terry S. Singeltary Sr.
 
Friday, March 18, 2016
 
CFSAN Constituent Update: FDA Announces Final Rule on Bovine Spongiform Encephalopathy BSE MAD COW TSE PRION
 
Center for Food Safety and Applied Nutrition - Constituent Update
 
 
PLEASE REMEMBER, IN 55 YEARS AND OLDER, THE RATE OF DOCUMENTED CJD JUMPS TO ONE IN 9,000. the cases are mounting...
 
Thursday, April 14, 2016
 
*** Arizona 22 year old diagnosed with Creutzfeldt Jakob Disease CJD ***
 
 
Terry S. Singeltary Sr. Bacliff, Texas USA 77518 flounder9@verizon.net