Thursday, November 16, 2017

Texas Natural Meats Recalls Beef Products Due To Possible Specified Risk Materials Contamination

News Release

Texas Natural Meats Recalls Beef Products Due To Possible Specified Risk Materials Contamination

Class II Recall122-2017
Health Risk: LowNov 15, 2017
Congressional and Public Affairs
Brett Filloon
(202) 720-9113
Press@fsis.usda.gov

WASHINGTON, Nov. 15, 2017 – Texas Natural Meats, a Lott, Texas establishment, is recalling approximately 116 pounds of beef tongue products that may be contaminated with specified risk materials (SRMs), the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The raw intact beef tongue items were produced on various dates between April 1, 2016 and Nov. 11, 2017. The following products are subject to recall: [View Label (PDF Only)]
  • 1.72-lb. cryovac packages of frozen “Beef Tongue”.
The products subject to recall bear establishment number “EST. 34449” inside the USDA mark of inspection. These items were shipped to product owners and further distributed in Texas.                           
The problem was discovered on Nov. 15, 2017 by FSIS, while conducting inspection verification activities.
There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.  
Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers.
Consumers and media with questions about the recall can contact C.W. Whorton, Plant Manager, at (254) 584-0115.
Consumers with food safety questions can "Ask Karen," the FSIS virtual representative available 24 hours a day at AskKaren.gov or via smartphone at m.askkaren.gov. The toll-free USDA Meat and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and Spanish and can be reached from 10 a.m. to 6 p.m. (Eastern Time) Monday through Friday. Recorded food safety messages are available 24 hours a day. The online Electronic Consumer Complaint Monitoring System can be accessed 24 hours a day at: http://www.fsis.usda.gov/reportproblem.
USDA Recall Classifications
Class IThis is a health hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death.
Class IIThis is a health hazard situation where there is a remote probability of adverse health consequences from the use of the product.
Class IIIThis is a situation where the use of the product will not cause adverse health consequences.



Specified Risk Materials Program
 
The Specified Risk Materials Program is intended to allow qualified investigators to seek funding for research directly related to the following areas of specified risk materials (SRM): detection of prions in complex matrices; SRM as feedstock for processes and products; disposition and disposal methods; cost benefit estimates of existing or new disposition and disposal methodologies; risk assessment; risk communication about SRM and risks and benefits of disposition and disposal of SRM; and other.
 
Funding is accessible for all relevant fields of inquiry in the themes as described in the guidelines to develop innovative disposition and disposal methods and/or uses of specified risk materials. This competition will support grants of up to $500,000 for a period of up to three years. Applications are due August 15, 2016.
 
>> Application Guidelines
 
Explorations Program The Explorations Program allows Alberta-based investigators to seek funding for research directly related to prion diseases and prion-like human neurodegenerative diseases and dementias. The research themes for this program are protein folding and misfolding in prion diseases, the pathobiology of transmissible spongiform encephalopathies (TSEs), surveillance and control of prion diseases, TSEs and society, protein folding and misfolding in prion-like human neurodegenerative diseases, and prion-like mechanisms in human neurodegenerative diseases.
 
The Alberta Prion Research Institute offers two tiers of funding for the Explorations competition: grants of up to $200,000 for a maximum of two years and grants of up to $500,000 for a maximum of three years. Applications are due August 31, 2016.
 
>> Application Guidelines
 
Research Team Program The Research Team Program allows teams of qualified investigators to seek funding for research directly related to prion diseases and prion-like human neurodegenerative diseases and dementias. The research themes for this program are protein folding and misfolding in prion diseases, the pathobiology of TSEs, surveillance and control of prion diseases, TSEs and society, protein folding and misfolding in prion-like human neurodegenerative diseases and prion-like mechanisms in the pathobiology of prion-like human neurodegenerative diseases.
 
The program is designed to encourage collaboration within Alberta and between Alberta-based investigators and researchers outside of Alberta. The team of researchers must be from at least two different research institutions. The Alberta Prion Research Institute provides up to $750,000 for a team grant over a maximum of three years. The total from partners provided to support a Research Team proposal will be a cash contribution of at least 25 per cent of the total amount contributed by the Prion Institute (at least 20 per cent of total project costs). Applications are due August 31, 2016.
 
>> Application Guidelines
 
Grant Crafting Workshops The Alberta Prion Research Institute is offering grant crafting workshops in Edmonton and Calgary. The grant crafting workshops will include presentations from two researchers with experience crafting and reviewing proposals, including one member of the Prion Institute’s International Research Advisory Council. These sessions are open to research administrators, principal investigators, postdocs, grad students and other lab members.
 
Tuesday, June 21 – Edmonton 1:30 – 3:30 p.m. 204 Brain and Aging Research Building Centre for Prions and Protein Folding Diseases, University of Alberta
 
Wednesday, June 22 – Calgary 9 – 11 a.m. TRW 2E23 University of Calgary Foothills Campus
 
 
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
 
Subject: 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
 
SCIENTIFIC COMMITTEE OF THE BELGIAN FEDERAL AGENCY FOR THE SAFETY OF THE FOOD CHAIN
 
RAPID ADVICE 17-2014
 
Subject: 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 (Dossier SciCom 2014/22) Rapid advice approved by the Scientific Committee on 22nd October 2014.
 
Summary
 
The Scientific Committee was asked to answer two questions in regard to a proposal from the European Commission to no longer obligate Member States with a negligible BSE risk status to remove and dispose the specified risk materials as specified in Annex V to Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies. The aim of this modification of the Regulation is to ensure that conditions for imports of commodities from third countries are not more favorable than the conditions applying to Member States with the same OIE BSE negligible risk status. More specifically it was asked to the Scientific Committee:
 
- If there is a difference in public health risk between the casings imported from third countries with a “negligible risk status for BSE” and casings that come from the 18 EU Member States with a “negligible risk status for BSE”?
 
- If there is a significantly increased public health risk if, in the EU Member States with a “negligible risk status for BSE”, the intestines are no longer removed as SRM and if the other risk materials for BSE (the skull including the brains and eyes, the spinal cord, the tonsils and the spine) are indeed considered as SRM?
 
Due to lack of availability of data on true prevalence and tissue infectivity of BSE (classical as well as atypical BSE) the Scientific Committee was not able to thoroughly investigate the questions.
 
Removal of specified risk materials from cattle at slaughter prevents BSE infected materials from entering the human food chain.
 
The Scientific Committee is of the opinion that, taking into consideration the uncertainties in regard to the true prevalence of BSE (classical as well as atypical BSE) in countries with a “negligible risk status for BSE” and given the problems related with the early detection of asymptomatic BSE and given the zoonotic significance of atypical BSE, that stopping with the routine removal of specified risk materials during bovine slaughter will increase the risk for public health.
 
2/14
 
The Scientific Committee is not able to compare the public health risk of casings from third countries and from the 18 EU Member States, both with a negligible risk status for BSE, because of lack of data on true BSE prevalence and BSE tissue infectivity (classical BSE and atypical BSE) in the considered countries.
 
The Scientific Committee is also not able to properly answer the second question if there is a significantly increased public health risk if, in the EU Member States with a “negligible risk status for BSE”, the intestines are no longer removed as SRM due to lack of quantitative data on tissue infectivity of different specified risk materials in slaughtered bovines in these countries. There is also no information on tissue infectivity of atypical BSE cases. It is known however that intestines are the portal of entry of prions and that they are already infective before the prions reach the central nervous system.
 
The final decision pertaining the need of removal of all or part of the specified risk materials is a risk management decision and goes beyond the competencies of the Scientific Committee.
 
Samenvatting Sneladvies over de risico’s voor de volksgezondheid van worstenvellen in landen met een “verwaarloosbaar risicostatuut voor BSE” en over de risico’s van wijziging van een lijst van gespecifieerde risicomaterialen (GRM) voor BSE
 
snip...
 
In conclusion the Scientific Committee is not able to answer this question with an acceptable degree of uncertainty because of lack of data on true prevalence of BSE (classical as well as atypical forms of BSE) in the considered countries. It reiterates its concern regarding the import of certain animal products from third countries with a ‘negligible BSE risk status’ as stated in rapid advice SciCom 16-2013.
 
snip...
 
2. Is there a significantly increased public health risk if, in the EU Member States with a “negligible risk status for BSE”, the intestines are no longer removed as SRM while the other risk materials for BSE (the skull including the brains and eyes, the spinal cord, the tonsils and the spine) are indeed considered as SRM?
 
Once again the Scientific Committee is not able to properly answer this question because of lack of quantitative data on tissue infectivity of different specified risk materials in slaughtered bovines in EU Member States with a “negligible risk status for BSE”.
 
BSE infected animals may enter undetected the food chain due to the low sensitivity of the diagnostic tests. Further on the classical BSE agent accumulates from the first months post exposure in particular segments of the bovine intestines and persists till clinical onset. In addition no information is available about the infectivity of tissues by the atypical BSE agent, especially in the intestines.
 
If intestines from cattle in EU Member States with a “negligible risk status for BSE” are no longer removed as SRM and are allowed to enter the food chain the public health risk will be increased. The degree of rise in risk level cannot be determined. According to EFSA Journal 2014;12(2):3554, the TSEi model indicated that the removal of the last four meters of the small intestine and of the caecum from the food and feed chain would result in a major reduction of the Classical BSE exposure risk associated with intestine and mesentery in cattle.
 
Referring to its previous advice 16-2013 the Scientific Committee repeats that stopping with the routine removal of all specified risk materials during bovine slaughter will increase the risks of exposure of the population to BSE because of the uncertainty related to the detection of BSE. This uncertainty is the consequence of the long incubation period (especially in cases of atypical BSE), the low sensitivity of the available diagnostic methods, the apparent spontaneous nature of atypical BSE, the lack of a clear clinical picture of atypical BSE cases and the reduction in number of tests in healthy slaughtered animals.
 
The final decision pertaining the need of removal of all or part of the specified risk materials is a decision to be taken by the risk manager and goes beyond the competencies of the Scientific Committee.
 
5. Conclusion
 
Removal of specified risk materials from cattle at slaughter prevents BSE infected materials from entering the human food chain.
 
The Scientific Committee is of the opinion that, taking into consideration the uncertainties in regard to the true prevalence of BSE (including classical as well asaAtypical BSE) in countries with a “negligible risk status for BSE” and given the problems related with the early detection of asymptomatic BSE and given the zoonotic character of atypical BSE, stopping with the routine removal of all specified risk materials during bovine slaughter will increase the risk for public health.
 
12/14
 
The Scientific Committee is not able to compare the public health risk of casings from third countries and from the 18 EU Member States both with a negligible risk status for BSE because of lack of data on true BSE prevalence (classical BSE and atypical BSE) in the considered countries.
 
The Scientific Committee is not able to properly answer the question if there is a significantly increased public health risk if, in the EU Member States with a “negligible risk status for BSE”, the intestines are no longer removed as SRM due to lack of quantitative data on tissue infectivity of different specified risk materials in slaughtered bovines in these countries. There is also no information on tissue infectivity by the agent of atypical BSE.
 
On behalf of the Scientific Committee, The President Prof. Dr. E. Thiry (Sgd.) Brussels, 06/11/2014
 
References
 
snip...end
 
 
Thursday, July 24, 2014
 
Protocol for further laboratory investigations into the distribution of infectivity of Atypical BSE SCIENTIFIC REPORT OF EFSA
 
 
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
 
 
In the USA, USDA et al sometimes serves SRM’s up as appetizers or horderves.
 
Thursday, November 28, 2013
 
Department of Justice Former Suppliers of Beef to National School Lunch Program Settle Allegations of Improper Practices and Mistreating Cows
 
 
seems USDA NSLP et al thought that it would be alright, to feed our children all across the USA, via the NSLP, DEAD STOCK DOWNER COWS, the most high risk cattle for mad cow type disease, and other dangerous pathogens, and they did this for 4 years, that was documented, then hid what they did by having a recall, one of the largest recalls ever, and they made this recall and masked the reason for the recall due to animal abuse (I do not condone animal abuse), not for the reason of the potential for these animals to have mad cow BSE type disease (or other dangerous and deadly pathogens). these TSE prion disease can lay dormant for 5, 10, 20 years, or longer, WHO WILL WATCH OUR CHILDREN FOR THE NEXT 5 DECADES FOR CJD ???
 
Saturday, September 21, 2013
 
Westland/Hallmark: 2008 Beef Recall A Case Study by The Food Industry Center January 2010 THE FLIM-FLAM REPORT
 
 
DID YOUR CHILD CONSUME SOME OF THESE DEAD STOCK DOWNER COWS, THE MOST HIGH RISK FOR MAD COW DISEASE ???
 
this recall was not for the welfare of the animals. ...tss you can check and see here ; (link now dead, does not work...tss)
 
 
try this link ;
 
 
Sunday, November 13, 2011
 
*** California BSE mad cow beef recall, QFC, CJD, and dead stock downer livestock
 
 
Wednesday, March 2, 2016
 
RANCHO He did not know that they were placing healthy cow heads next to suspect carcasses BSE TSE Prion
 
 
Sunday, June 14, 2015
 
Larry’s Custom Meats Inc. Recalls Beef Tongue Products That May Contain Specified Risk Materials BSE TSE Prion
 
 
Thursday, June 12, 2014
 
Missouri Firm Recalls Ribeye and Carcass Products That May Contain Specified Risk Materials 4,012 pounds of fresh beef products because the dorsal root ganglia may not have been completely removed
 
 
Saturday, November 10, 2012
 
Wisconsin Firm Recalls Beef Tongues That May Contain Specified Risk Materials Nov 9, 2012 WI Firm Recalls Beef Tongues
 
 
Saturday, July 23, 2011
 
CATTLE HEADS WITH TONSILS, BEEF TONGUES, SPINAL CORD, SPECIFIED RISK MATERIALS (SRM's) AND PRIONS, AKA MAD COW DISEASE
 
 
Sunday, October 18, 2009
 
Wisconsin Firm Recalls Beef Tongues That Contain Prohibited Materials SRM WASHINGTON, October 17, 2009
 
 
Thursday, October 15, 2009
 
Nebraska Firm Recalls Beef Tongues That Contain Prohibited Materials SRM WASHINGTON, Oct 15, 2009
 
 
Thursday, June 26, 2008
 
Texas Firm Recalls Cattle Heads That Contain Prohibited Materials
 
 
Tuesday, July 1, 2008
 
Missouri Firm Recalls Cattle Heads That Contain Prohibited Materials SRMs
 
 
Friday, August 8, 2008
 
Texas Firm Recalls Cattle Heads That Contain Prohibited Materials SRMs 941,271 pounds with tonsils not completely removed
 
 
Saturday, April 5, 2008
 
SRM MAD COW RECALL 406 THOUSAND POUNDS CATTLE HEADS WITH TONSILS KANSAS
 
 
Wednesday, April 30, 2008
 
Consumption of beef tongue: Human BSE risk associated with exposure to lymphoid tissue in bovine tongue in consideration of new research findings
 
 
Wednesday, April 30, 2008
 
Consumption of beef tongue: Human BSE risk associated with exposure to lymphoid tissue in bovine tongue in consideration of new research findings
 
 
Friday, October 15, 2010
 
BSE infectivity in the absence of detectable PrPSc accumulation in the tongue and nasal mucosa of terminally diseased cattle
 
 
SPECIFIED RISK MATERIALS SRMs
 

SPECIFIED RISK MATERIAL SRM 2016

 
Subject: USDA OIG SEMIANNUAL REPORT TO CONGRESS FY 2007 1st Half (bogus BSE sampling FROM HEALTHY USDA CATTLE)
 
Date: June 21, 2007 at 2:49 pm PST
 
Owner and Corporation Plead Guilty to Defrauding Bovine Spongiform Encephalopathy (BSE) Surveillance Program
 
An Arizona meat processing company and its owner pled guilty in February 2007 to charges of theft of Government funds, mail fraud, and wire fraud. The owner and his company defrauded the BSE Surveillance Program when they falsified BSE Surveillance Data Collection Forms and then submitted payment requests to USDA for the services.
 
In addition to the targeted sample population (those cattle that were more than 30 months old or had other risk factors for BSE),
 
*** the owner submitted to USDA, or caused to be submitted, BSE obex (brain stem) samples from healthy USDA-inspected cattle.
 
As a result, the owner fraudulently received approximately $390,000. Sentencing is scheduled for May 2007.
 
snip...
 
Topics that will be covered in ongoing or planned reviews under Goal 1 include:
 
soundness of BSE maintenance sampling (APHIS),
 
implementation of Performance-Based Inspection System enhancements for specified risk material (SRM) violations and improved inspection controls over SRMs (FSIS and APHIS),
 
snip...
 
The findings and recommendations from these efforts will be covered in future semiannual reports as the relevant audits and investigations are completed.
 
4 USDA OIG SEMIANNUAL REPORT TO CONGRESS FY 2007 1st Half
 

BARB = BORN AFTER RUMINANT BAN

ITEM 4 – BSE UPDATE

10. Mr Patrick Burke (Defra) presented epidemiological data on BSE cases in the GB cattle herd, and of cases in other countries, and summarised the surveillance undertaken in the UK. The GB BSE epidemic peaked in 1992 with over 36,000 cases confirmed. This has since been in steep decline with 203 cases confirmed in 2005 and only a few (n=18) confirmed cases so far in 2006. The average age of onset of clinical BSE has increased with time. The proportion of clinical suspect cases subsequently confirmed as BSE has declined, probably due to the reduction in number of BSE infected cattle in relation to the number with other diseases. The incidence of GB BSE cases born after the 1996 reinforced feed ban (BARB cases) was also in decline. To date, 124 GB BARB cases had been identified. Most of these were detected in casualty animals that had been subjected to emergency slaughter under the over thirty-month scheme. Data on the number of BARB cases by birth cohort showed a peak in 2003, a subsequent decline in 2004, but an increase in 2005. This increase could partially be attributed to the introduction of a cohort cull in March 2005, leading to earlier detection of BARB cases. In the absence of the cull, it is likely these cases would have only been detected in later years through active surveillance or as clinical cases. Epidemiological data on BSE worldwide showed a wide geographical distribution but an overall decline in the incidence of the disease.

11. Members asked about the increase in BARB cases in 2005. Mr Burke explained that introduction of the cohort cull in March 2005 allowed detection of positive cases at an earlier stage and could partially explain the increase observed. A member observed that the end of the Over Thirty Month Scheme and changes to emergency slaughter rules which both came into effect in early 2006 might have encouraged farmers to submit more older cattle for slaughter in later 2005, and this might also have contributed to the identification of more cases in 2005. In view of these variables, revised backcalculation estimates of prevalence in the BARB cohorts would be a more useful indicator than observed incidence. Dr Danny Matthews (VLA) noted that cattle born later were exposed to relatively low doses of infectivity compared with historic 

7 © SEAC 2006

exposures, and so would be expected to have relatively long incubation periods. Thus, it is likely that animals infected late in the epidemic have yet to be identified in relatively recent birth cohorts. The committee were satisfied that the increase in number of cases identified in 2005 was unlikely to reflect a real increase in the number of infected animals, but instead reflects changes in surveillance and other factors. 




THURSDAY, JULY 20, 2017 

USDA OIE Alabama Atypical L-type BASE Bovine Spongiform Encephalopathy BSE animal feeds for ruminants rule, 21 CFR 589.200



SUNDAY, JULY 23, 2017

atypical L-type BASE Bovine Amyloidotic Spongiform Encephalopathy BSE TSE PRION



SUNDAY, JULY 23, 2017

Experimental Infection of Cattle With a Novel Prion Derived From Atypical H-Type Bovine Spongiform Encephalopathy



THURSDAY, AUGUST 17, 2017 

JAVMA NEWS Atypical BSE found in Alabama cow September 01, 2017



Saturday, July 23, 2016

BOVINE SPONGIFORM ENCEPHALOPATHY BSE TSE PRION SURVEILLANCE, TESTING, AND SRM REMOVAL UNITED STATE OF AMERICA UPDATE JULY 2016

 

Monday, June 20, 2016 

Specified Risk Materials SRMs BSE TSE Prion Program 



Final Feed Investigation Summary - California BSE Case - July 2012

On Tuesday, April 24, 2012, the California Department of Food and Agriculture (CDFA) and the U.S. Food and Drug Administration (FDA) were informed by the CDFA Animal Health Safety Service (AHSS) Division that a brain sample collected from a dead cow at the Baker Commodities rendering transfer station in Hanford, California tested positive for L-type atypical bovine spongiform encephalopathy (BSE). While cases of classical BSE have been clearly linked to the use of contaminated meat and bone meal (MBM) as an ingredient in cattle feed, the origin of atypical strains of BSE is unknown. Given the scientific uncertainty about the origin of the L-type strain of BSE, FDA and CDFA conducted a feed investigation to try to determine if any feed supplied to the index premises since the birth of the index cow could have been manufactured with or cross-contaminated by ingredients that are prohibited for use in feed for ruminant animals.

FDA published BSE feed regulations in 1997 and 2008 to protect against cattle exposure to the BSE agent through animal feed. The 1997 “feed ban” (21 CFR 589.2000) prohibits feeding mammalian protein, with certain exceptions such as for milk products and blood products, to ruminants. The 2008 “enhanced feed rule” (21 CFR 589.2001) addresses concerns that the 1997 rule might not completely eliminate the potential for cattle to be exposed to infectivity as a result of cross-contamination during feed manufacturing or distribution, or as a result of on-farm misfeeding of swine feed, poultry feed, or pet food to cattle. To further reduce the BSE risks associated with cross-contamination and on-farm misfeeding, the 2008 rule banned the use of the highest risk cattle tissues - the brain and spinal cord from cattle 30 months of age and older - in all animal feed. To investigate whether the BSE positive cow in California had access to feed ingredients containing bovine origin MBM, the CDFA and the FDA visited the index dairy farm where they evaluated the dairy farm’s compliance with BSE feed regulations, obtained the feeding history of the index cow since her birth in September 2001 to the present, and identified all feed suppliers to those premises where the cow had resided since birth. An inspection for compliance with 21 CFR 589.2000 and 589.2001 (a BSE inspection) was then conducted at each of the feed suppliers identified. In addition, inspection reports from all previous inspections at the identified feed firms were reviewed to determine each firm’s history of using prohibited material in feed manufacturing, as well as each firm’s history of compliance with FDA’s BSE feed regulations. Particular attention was focused on controls in place at each facility to prevent cross contamination.

Review of the BSE inspection histories found that compliance with BSE feed regulations was excellent. None of the facilities had used prohibited material in their feed manufacturing during the entire period of interest. All historical BSE inspections at the 12 feed suppliers were NAI (no action indicated) for all inspections conducted over the period of interest. One facility had minor violations (VAI, or voluntary action indicated) for medicated feed good manufacturing practices (GMP) deficiencies. Prior to the period of interest, one firm was OAI for an April 2000 inspection because the firm had inadequate cleanout procedures and failed to label product potentially containing prohibited material with the required caution statement “do not feed to cattle or other ruminants”. The next inspection of that facility, in May 2001 (6 months before the date of birth of the index cow), found that the facility no longer used prohibited material.

Although none of the facilities had used prohibited material in their feed manufacturing during the entire period of interest, one facility distributed prohibited material but did not use it to manufacture feeds. This facility maintained separation between its manufactured feed and products for distribution that contained prohibited material. Six facilities used only vegetable origin protein sources such as whole and rolled corn, soybean meal, canola meal, distillers dried grain, corn gluten, wheat, almond hulls, rolled barley, cottonseed, sunflower meal, and beet pulp. Five facilities used blood meal (one of the five used only porcine origin blood meal). Two used feather meal, two used fish meal, and one used porcine origin MBM. One facility processed and manufactured with poultry waste. Three facilities distributed pet food or sold it to retail customers. All three of these facilities kept the pet food in an area of the facility separated from feed manufacturing, with posted signs saying “do not feed to cattle or other ruminants.”

The reporting form used to conduct BSE inspections requires the investigator to verify that facilities that do not use prohibited material have safeguards in place to assure that the facility does not receive prohibited material. All 12 firms had procedures in place for obtaining written certification or other assurances from suppliers that products contained no prohibited material. Written procedures at each facility also required that plant personnel review labels of incoming product for prohibited ingredients. The inspection reports showed that each feed supplier also had appropriate procedures for ensuring that vehicles used to haul incoming or outgoing product had either not previously hauled product containing prohibited material, or had been properly cleaned. This feed investigation found that no feed suppliers to the index premises processed with prohibited material during the period of interest, that all feed facilities obtained appropriate assurances from their suppliers that incoming ingredients did not contain prohibited material, and that vehicle inspections and/or driver certifications were used by all facilities to ensure that products were not transported in vehicles that had hauled product containing prohibited material in the previous load. Based on these findings, the feed investigation team did not identify any conditions where feed ingredients supplied to the index premises had been manufactured with prohibited material, or where feed suppliers to the index premises did not have adequate safeguards in place to prevent cross-contamination during feed manufacture, storage, or transportation.

Additional Information

USDA Summary Report - California BSE Case Investigation - July 2012 


Wednesday, April 25, 2012

4th MAD COW DISEASE U.S.A. CALIFORNIA ATYPICAL L-TYPE BSE 2012


2012 ATYPICAL L-TYPE BASE BSE TSE PRION CALIFORNIA ‘confirmed’ 

Saturday, August 4, 2012

*** Final Feed Investigation Summary - California BSE Case - July 2012



SPONTANEOUS ATYPICAL BOVINE SPONGIFORM ENCEPHALOPATHY

***Moreover, sporadic disease has never been observed in breeding colonies or primate research laboratories, most notably among hundreds of animals over several decades of study at the National Institutes of Health25, and in nearly twenty older animals continuously housed in our own facility.***



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. ***

P.9.21

Molecular characterization of BSE in Canada

Jianmin Yang 1 , Sandor Dudas 2 , Catherine Graham 2 , Markus Czub 3 , Tim McAllister 1 , Stefanie Czub 1 1 Agriculture and Agri-Food Canada Research Centre, Canada; 2 National and OIE BSE Reference Laboratory, Canada; 3 University of Calgary, Canada

Background: Three BSE types (classical and two atypical) have been identified on the basis of molecular characteristics of the misfolded protein associated with the disease. To date, each of these three types have been detected in Canadian cattle. Objectives: This study was conducted to further characterize the 16 Canadian BSE cases based on the biochemical properties of there associated PrPres.

Methods: Immuno-reactivity, molecular weight, glycoform profiles and relative proteinase K sensitivity of the PrPres from each of the 16 confirmed Canadian BSE cases was determined using modified Western blot analysis.

Results: Fourteen of the 16 Canadian BSE cases were C type, 1 was H type and 1 was L type. The Canadian H and L-type BSE cases exhibited size shifts and changes in glycosylation similar to other atypical BSE cases. PK digestion under mild and stringent conditions revealed a reduced protease resistance of the atypical cases compared to the C-type cases. N terminal-specific antibodies bound to PrPres from H type but not from C or L type. The C-terminal-specific antibodies resulted in a shift in the glycoform profile and detected a fourth band in the Canadian H-type BSE.

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



*** Singeltary reply ; Molecular, Biochemical and Genetic Characteristics of BSE in Canada Singeltary reply;



***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



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?



MICHIGAN FDA PART 589 -- SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED VIOLATIONS OFFICIAL ACTION INDICATED OAI UPDATE BREACH APRIL 4, 2017

Greetings FDA HHS et al Enforcement Reports,

i have followed the mad cow saga since December 14, 1997, when i lost my Mom to the hvCJD. without going into all that and what i have been doing since then to bring awareness, i am reaching out to you privately, because i do not want to have to wait another 10 years to finally get an answer via the FOIA on feed or the infamous mad sheep of mad river valley testing blunder. i'm getting old and probably will not be around in 10 years. but what i am look for, you might be able to help me out with, and i will keep the source 'in confidence'. what i am looking for is the full report and amount of product in commerce being recalled (if any). i am extremely concerned with the 21 CFR 589.2000 feed regulations and risk factors there from cervid, pigs, dogs, cats. we now have cwd transmitting to pigs orally in the lab, and this is getting serious now. i know OAI actions are severe from the past OAIs and investigations there from. but if you could please give me a full report of exactly what this OAI violation consisted of, or someone that can, without years of FOIA requests and denials and appeals, it would be most helpful, and very much appreciated. i am not the enemy, i have simply been trying to fix a wrong for almost 2 decades every day, but seems i have failed. i made a promise to mom, never forget, and never let them forget. i hope to hear back from you...

with kindest regards, terry 

11998 DET-DO MI 48846-847 OPR 4/4/2017 OAI 

Subject: MICHIGAN FDA PART 589 -- SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED VIOLATIONS OFFICIAL ACTION INDICATED OAI UPDATE BREACH APRIL 4, 2017

MICHIGAN FDA PART 589 -- SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEEDVIOLATIONS OFFICIAL ACTION INDICATED OAI UPDATE BREACH APRIL 4, 2017

FDA BSE/Ruminant Feed Inspections Firms Inventory 

11998 DET-DO MI 48846-847 OPR 4/4/2017 OAI 



NAI = NO ACTION INDICATED

OAI = OFFICIAL ACTION INDICATED

VAI = VOLUNTARY ACTION INDICATED

RTS = REFERRED TO STATE

OAI (Official Action Indicated) when inspectors find significant objectionable conditions or practices and believe that regulatory sanctions are warranted to address the establishment’s lack of compliance with the regulation. An example of an OAI classification would be findings of manufacturing procedures insufficient to ensure that ruminant feed is not contaminated with prohibited material. Inspectors will promptly re-inspect facilities classified OAI after regulatory sanctions have been applied to determine whether the corrective actions are adequate to address the objectionable conditions.


FY 2016 Inspectional Observation Summaries

4132 21 CFR 589.2000(d)(1) Protein blenders, feed manufacturers, distributors Products that contain or may contain prohibited material fail to bear the caution statement, "Do not feed to cattle or other ruminants." Specifically, *** 2

4131 21 CFR 589.2000(c)(1)(i) Renderers Products that contain or may contain prohibited material fail to bear a label containing the caution statement, "Do not feed to cattle or other ruminants." Specifically, *** 1



FY 2015 Inspectional Observation Summaries

4132 21 CFR 589.2000(d)(1) Protein blenders, feed manufacturers, distributors Products that contain or may contain prohibited material fail to bear the caution statement, "Do not feed to cattle or other ruminants." Specifically, *** 2



FY 2014 Inspectional Observation Summaries

4146 21 CFR 589.2000(e)(1) Written clean-out procedures Failure to maintain written clean-out procedures to prevent carryover of protein derived from mammalian tissues to animal protein or feeds that may be used for ruminants. Specifically, *** 2

4131 21 CFR 589.2000(c)(1)(i) Renderers Products that contain or may contain prohibited material fail to bear a label containing the caution statement, "Do not feed to cattle or other ruminants." Specifically, *** 1

4132 21 CFR 589.2000(d)(1) Protein blenders, feed manufacturers, distributors Products that contain or may contain prohibited material fail to bear the caution statement, "Do not feed to cattle or other ruminants." Specifically, *** 1

4145 21 CFR 589.2000(e)(1) Use of clean-out procedures Failure to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissues to animal protein or feeds that may be used for ruminants. Specifically, *** 1



FY 2013 Inspectional Observation Summaries

4131 21 CFR 589.2000(c)(1)(i) 5 Renderers Products that contain or may contain prohibited material fail to bear a label containing the caution statement, "Do not feed to cattle or other ruminants." Specifically, ***

4132 21 CFR 589.2000(d)(1) 5 Protein blenders, feed manufacturers, distributors Products that contain or may contain prohibited material fail to bear the caution statement, "Do not feed to cattle or other ruminants." Specifically, ***

4145 21 CFR 589.2000(e)(1) 1 Use of clean-out procedures Failure to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissues to animal protein or feeds that may be used for ruminants. Specifically, ***

4146 21 CFR 589.2000(e)(1) 1 Written clean-out procedures Failure to maintain written clean-out procedures to prevent carryover of protein derived from mammalian tissues to animal protein or feeds that may be used for ruminants. Specifically, ***

FY 2012 Inspectional Observation Summaries

4131 21 CFR 589.2000(c)(1)(i) 5 Renderers Products that contain or may contain prohibited material fail to bear a label containing the caution statement, "Do not feed to cattle or other ruminants." Specifically, ***

4132 21 CFR 589.2000(d)(1) 4 Protein blenders, feed manufacturers, distributors Products that contain or may contain prohibited material fail to bear the caution statement, "Do not feed to cattle or other ruminants." Specifically, ***



FY 2011 Inspectional Observation Summaries

4132 21 CFR 589.2000(d)(1) 5 Protein blenders, feed manufacturers, distributors Products that contain or may contain prohibited material fail to bear the caution statement, "Do not feed to cattle or other ruminants."Specifically, ***

4131 21 CFR 589.2000(c)(1)(i) 4 Renderers Products that contain or may contain prohibited material fail to bear a label containing the caution statement, "Do not feed to cattle or other ruminants."Specifically, ***

4146 21 CFR 589.2000(e)(1) 1 Written clean-out procedures Failure to maintain written clean-out procedures to prevent carryover of protein derived from mammalian tissues to animal protein or feeds that may be used for ruminants. Specifically, ***



FY 2010 Inspectional Observation Summaries

4131 21 CFR 589.2000(c)(1)(i) 3 Renderers Products that contain or may contain prohibited material fail to bear a label containing the caution statement, "Do not feed to cattle or other ruminants." Specifically, *** 4132 21 CFR 589.2000(d)(1) 3 Protein blenders, feed manufacturers, distributors Products that contain or may contain prohibited material fail to bear the caution statement, "Do not feed to cattle or other ruminants." Specifically, ***

4146 21 CFR 589.2000(e)(1) 1 Written clean-out procedures Failure to maintain written clean-out procedures to prevent carryover of protein derived from mammalian tissues to animal protein or feeds that may be used for ruminants. Specifically, ***



FY 2009 Inspectional Observation Summaries

4132 21 CFR 589.2000(d)(1) 10 Protein blenders, feed manufacturers, distributors Products that contain or may contain prohibited material fail to bear the caution statement, "Do not feed to cattle or other ruminants." Specifically, ***

4146 21 CFR 589.2000(e)(1) 4 Written clean-out procedures Failure to maintain written clean-out procedures to prevent carryover of protein derived from mammalian tissues to animal protein or feeds that may be used for ruminants. Specifically, ***

4145 21 CFR 589.2000(e)(1) 3 Use of clean-out procedures Failure to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissues to animal protein or feeds that may be used for ruminants. Specifically, ***



FY 2008 Inspectional Observation Summaries

4132 21 CFR 589.2000(d)(1) 7 Protein blenders, feed manufacturers, distributors Products that contain or may contain prohibited material fail to bear the caution statement, "Do not feed to cattle or other ruminants." Specifically, ***

4145 21 CFR 589.2000(e)(1) 1 Use of clean-out procedures Failure to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissues to animal protein or feeds that may be used for ruminants. Specifically, *** 4146 21 CFR 589.2000(e)(1) 1 Written clean-out procedures Failure to maintain written clean-out procedures to prevent carryover of protein derived from mammalian tissues to animal protein or feeds that may be used for ruminants. Specifically, ***



FY 2007 Inspectional Observation Summaries

4132 21 CFR 589.2000(d)(1) 3 Protein blenders, feed manufacturers, distributors Products that contain or may contain prohibited material fail to bear the caution statement, "Do not feed to cattle or other ruminants." Specifically, ***

4146 21 CFR 589.2000(e)(1) 3 Written clean-out procedures Failure to maintain written clean-out procedures to prevent carryover of protein derived from mammalian tissues to animal protein or feeds that may be used for ruminants. Specifically, ***

4131 21 CFR 589.2000(c)(1)(i) 2 Renderers Products that contain or may contain prohibited material fail to bear a label containing the caution statement, "Do not feed to cattle or other ruminants." Specifically, ***

4145 21 CFR 589.2000(e)(1) 1 Use of clean-out procedures Failure to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissues to animal protein or feeds that may be used for ruminants. Specifically, ***



FY 2006 Inspectional Observation Summaries

4132 21 CFR 589.2000(d)(1) 6 Protein blenders, feed manufacturers, distributors Products that contain or may contain prohibited material fail to bear the caution statement, "Do not feed to cattle or other ruminants."Specifically, ***

4146 21 CFR 589.2000(e)(1) 5 Written clean-out procedures Failure to maintain written clean-out procedures to prevent carryover of protein derived from mammalian tissues to animal protein or feeds that may be used for ruminants. Specifically, ***

4145 21 CFR 589.2000(e)(1) 4 Use of clean-out procedures Failure to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissues to animal protein or feeds that may be used for ruminants. Specifically, ***

4131 21 CFR 589.2000(c)(1)(i) 2 Renderers Products that contain or may contain prohibited material fail to bear a label containing the caution statement, "Do not feed to cattle or other ruminants." Specifically, ***



TUESDAY, APRIL 18, 2017 

EXTREME USA FDA PART 589 TSE PRION FEED LOOP HOLE STILL EXIST, AND PRICE OF POKER GOES UP



TUESDAY, JANUARY 17, 2017 

FDA PART 589 -- SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEEDVIOLATIONS OFFICIAL ACTION INDICATED OAI UPDATE 2016 to 2017 BSE TSE PRION



Sunday, March 20, 2016

Docket No. FDA-2003-D-0432 (formerly 03D-0186) Use of Material from Deer and Elk in Animal Feed ***UPDATED MARCH 2016*** Singeltary Submission



SEE MAD COW FEED VIOLATIONS AFER MAD COW FEED VIOLATIONS



Tuesday, April 19, 2016

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



Monday, October 26, 2015 

FDA PART 589 -- SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED VIOLATIONS OFFICIAL ACTION INDICATED OIA UPDATE October 2015 



Sunday, September 27, 2015

TEXAS CONFIRMATION OF BOVINE SPONGIFORM ENCEPHALOPATHY BSE TSE PRION IN ONE SAMPLE OF SORGHUM DDGS OUT OF 168 DG SAMPLES



*** STRICTLY IN CONFIDENCE ***

BSE 

S33/94

Sampling of Ruminant Feeding Stuffs For Ruminant Protein



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 



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 



2012-2014


Newberry Feed & Farm, Inc. 2/14/14 

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service

Food and Drug Administration

 Atlanta District Office

60 8th St., NE

Atlanta, GA 30309 

February 14, 2014

VIA UPS J. Clint Layne, President/Co-owner Rhett Baker, Secretary-Treasurer/Co-owner Newberry Feed & Farm Center, Inc. 131 Giff Street Newberry, SC 29108

 WARNING LETTER (14-ATL-04) 

Dear Messrs. Layne and Baker,

 An inspection of your feed mill located at 2431 Vincent Street, Newberry, SC 29108 conducted by Investigators from the U.S. Food & Drug Administration (FDA) and South Carolina Department of Agriculture on September 5-9, 2013 revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for Medicated Feeds found in Title 21, Code of Federal Regulations, Part 225 (21 C.F.R. 225). Such violations cause the medicated feeds manufactured at your facility to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 351(a)(2)(B)] in that the methods used in, or the facilities or controls used for the manufacture, processing, packing, or holding of the medicated feeds do not conform to or are not operated or administered in conformity with current good manufacturing practices. 

 The inspection also revealed significant violations of the requirements set forth in Title 21, Code of Federal Regulations, Section 589.2000 (21 C.F.R. 589.2000), Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Animal feeds and feed ingredients containing prohibited mammalian proteins are considered potentially injurious to ruminant and public health. Because you failed to comply with the requirements set forth in 21 C.F.R. 589.2000, the feed products manufactured and distributed by your facility are adulterated within the meaning of Section 402(a)(4) of the Act [21 U.S.C. 342(a)(4)] in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. The adulterated feed was subsequently misbranded within the meaning of Section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] because it was not properly labeled with the required BSE cautionary statement.

 Medicated Feed CGMP violations observed during the inspection include, but are not limited to, the following: 

1. You failed to ensure that all equipment that comes in contact with the active drug component, feeds in process or finished medicated feed is subject to reasonable and effective procedures to prevent unsafe contamination of feeds with drugs. [21 C.F.R. 225.65(b)] 

Your written equipment cleaning procedure that requires flushing with a minimum of (b)(4) does not appear to be effective to prevent unsafe contamination of your manufactured feed. During the inspection, our Investigators observed a build-up of feed residue on surfaces inside the mixer that was approximately three inches thick in accumulation. This build-up was observed on the equipment throughout the inspection, including after flushing had been performed. In addition, the cleaning procedure does not include cleaning of the hand-add chute or scoops/buckets used to handle ingredients that are then used to manufacture medicated feed. During the inspection, our Investigators observed a build-up of feed residues approximately four inches thick on the inside of the chute used to add the drug ingredients and other “hand-adds”. Considering the extent of residue accumulation—some of which would include the drug sources used in your medicated feeds—on surfaces in the mixer and the hand-add chute, it is likely that chunks of this material break off periodically, and may sometimes end up in feeds not intended to contain that drug. 

 This is a repeat observation from the July 24-26, 2012 inspection. Your response to the Form FDA 483, Inspectional Observations, issued to you following the 2012 inspection stated the buckets and scoops would be replaced, and you would schedule a regular cleaning of the equipment every (b)(4). Based on the accumulation of residual feed observed on manufacturing equipment during the inspection and which remained following flushing, you have either failed to implement the promised corrective action or you have failed to ensure that the corrective action was lasting and effective in preventing the violation from recurring. 

On October 3, 2013, we received your response to the Form FDA 483 issued to you following the September 2013 inspection. You state in your response that you have posted signs, added cleaning of the dump chute to the (b)(4) cleaning procedure, and increased the physical cleaning of the mixer to (b)(4). You also state that dedicated scoops will be used for each component or drug and have ordered disposable liners for the buckets that will be discarded following each dumping of product. However, you did not provide any documentation to demonstrate these changes have been made, such as photos of the new sign or newly cleaned equipment, or copies of the revised cleaning procedure. 

2. You failed to investigate and implement corrective action where the results of assays indicated that the level of drug in medicated feed was not in accord with label specifications or not within permissible assay limits. An original or copy of the record of such action must be maintained on the premises. [21 C.F.R. 225.58(d)]

 Your firm failed to adequately investigate and implement corrective action when you received an assay result on 6/21/13 for a Type C medicated feed containing Amprolium, showing the drug present at 73% of the concentration stated on the label. This assay result is outside of the assay limits of 80-120% established in 21 C.F.R. 558.4. The subsequent review of production and inventory records conducted by your firm revealed these records were “OK”, and it was determined the feed sample was taken incorrectly. Your firm’s “\investigation sheet” dated 6/21/13 states the corrective action as “[t]rying to make sure the samples are taken correctly.” No technique or procedural changes were made in response to the described corrective action, however. Thus, your firm failed to implement any corrective action in response to the out of specification assay result. 

Your firm also received assay results for a Type C medicated broiler feed containing a Salinomycin concentration of 75% on 7/7/12 and 78% on 8/3/12. These assay results are outside the specification tolerance of 80-120% of the concentration stated on the label. [21 C.F.R. 558.4]. Your firm did not initiate any investigation or corrective action after receiving these results. Failure to investigate and implement corrective action following an out-of-limits assay is a repeat observation from the July 24-26, 2012 inspection.

 In your response to the Form FDA 483 issued to you following the September 2013 inspection, you state that you have instructed personnel further on completing the investigation form and have also added sampling instructions to the procedures manual. However, you did not provide copies of the new/revised investigation form or the revisions to the procedures manual discussing sampling. 

3. Your daily inventory records fail to record the batches or production runs (or lots) of medicated feed in which each drug was used. [21 C.F.R. 225.42(b)(6)(iii)] Although your daily inventory records appear to contain all of the other required information, due to the way the form is designed, there is only space to record one batch per day per drug and no space to record the name of the product, lot number, or other identifier for that batch. Your daily inventory record must reflect every batch or lot of medicated feed manufactured each day. 

4. You failed to document in the daily inventory record actions taken to reconcile any discrepancies in the daily inventory record. [21 C.F.R. 225.42(b)(6)(v)] For example, the drug inventory conducted on 8/30/13 revealed a discrepancy with respect to one fifty pound bag of (b)(4)(a Type A medicated article). It does not appear that your firm took any action to reconcile this discrepancy. You state in your response to both #3 and #4 above that you have added an area to the inventory control sheet to report any drugs that do not reconcile, and that there is a space to make notes and/or adjustments to inventory to ensure they reconcile. However, you did not indicate that the inventory control sheet had been adjusted to provide for the possibility that any single drug may be used more than once a day, and you did not provide any documentation—such as a copy of the revised form—to demonstrate that these changes have been made. 

 5. You have failed to properly identify, store, handle, and control drugs in your mixing areas to maintain their integrity and identity [21 C.F.R. 225.42(b)(4)]. Our inspection found that your firm was storing bags of Type A Medicated Articles in a manner and location that allowed them to be covered in bird droppings.

 This finding also relates to your obligations under 21 C.F.R. 225.20(b)(2) and (3), which requires the facility to be maintained in a reasonably clean and orderly manner, and for access by birds and other pests to be minimized. During the September 5-6, 2013 inspection, our Investigators observed birds (greater than ten) nesting, flying, perched and foraging in the mill. Your response indicated that you are investigating ways to keep birds out of the mill, but that you did not yet have a plan at that time. You indicated that you would have a plan in place by November 1, 2013, but did not provide further information regarding any plan.

 In addition, the following violations of the Animal Proteins Prohibited in Ruminant Feed regulation [21 C.F.R. 589.2000] were observed during the inspection: 

1. You failed to use clean out procedures or other means adequate to prevent carryover of protein derived from mammalian tissues to feeds that may be used for ruminants [21 C.F.R. 589.2000(e)(1)(iii)(B)]. Your feed is therefore adulterated under Section 402(a)(4) [21 U.S.C. 342(a)(4)] of the Act. 

Because your firm uses animal proteins prohibited from use in ruminant feeds, and also makes feeds for ruminants, you are required to have a cleanout procedure adequate to prevent carryover into ruminant feeds. As noted above, our Investigators observed a significant build-up of feed residues inside the feed mixer and the hand-add chute, which remained following your cleanout procedure. This equipment is used for processing both proteins derived from mammalian tissues and feeds for ruminants. Since flushing was ineffective in removing the accumulated feed from the equipment, your clean out procedure was inadequate to prevent carryover of protein derived from mammalian tissues to feeds intended for ruminant animals. 

Your response indicates that your corrective actions for this item are the same as for Item 1 above. However, as noted above, you did not provide any documentation to demonstrate that the changes you discussed have been made, or that they were adequate to address this issue. 

2. You failed to label all products which contained or may have contained prohibited materials and that are intended for use in animal feed with the BSE cautionary statement, "Do not feed to cattle or other ruminants." [21 C.F.R. 589.2000(e)(1)(i).] 

As discussed above, your clean out procedure is inadequate to prevent carryover of protein derived from mammalian tissues to feeds intended for ruminant animals. Thus, all feeds manufactured using your mixer and hand-add chute that did not contain the BSE cautionary statement “Do not feed to cattle or other ruminants,” are misbranded under Section 403(a)(1) [21 U.S.C. 343(a)(1)] of the Act. For example, a batch of Carolina Choice Beef Conditioner Custom Mix (b)(4), manufactured on September 6, 2013, while there was a significant build-up of feed residues in the feed mixer, was misbranded as its label did not contain the required BSE cautionary statement. 

The above is not intended to be an all-inclusive list of violations at your facility. As a medicated and non-medicated feed manufacturer, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance with the law. You should take prompt action to correct these violations, and you should establish procedures whereby such violations do not recur. Failure to promptly correct these violations may result in regulatory and/or administrative sanctions. These sanctions include, but are not limited to, seizure, injunction, and/or notice of opportunity for a hearing on a proposal to withdraw approval of your Medicated Feed Mill License under Section 512(m)(4)(B)(ii) of the Act and 21 C.F.R. 515.22(c)(2). 

Based on the results of the September 5-9, 2013 inspection, evaluated together with the evidence before FDA when the Medicated Feed Mill License was approved, the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of medicated feeds are inadequate to assure and preserve the identity, strength, quality, and purity of the new animal drugs therein. This letter constitutes official notification under the law and provides you an opportunity to correct the above described violations. 

You should notify this office, in writing, within fifteen (15) working days of the receipt of this letter of the steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step being taken to correct the violations and prevent their recurrence. In your response, please include the timeframe in which the corrections will be completed and provide any documentation that will effectively assist us in evaluating whether the corrective actions have been made and the adequacy of such. If you are unable to complete the corrective actions within fifteen (15) working days, identify the reason for the delay and the time within which you will complete the corrections. Include copies of any available documentation demonstrating that corrections have been made. 

Your written response should be sent to the U.S. Food and Drug Administration, Attn: Janice L. King, Compliance Officer, at the address noted in the letterhead. If you have questions, please contact Mrs. King at 843-746-2990 or write her at the noted address. 

Sincerely, /S/ Philip S. Campbell Acting District Director Atlanta District Office 

cc: South Carolina Department of Agriculture, Phillip C. Trefsgar 


 
Rocky Ford Pet Foods 8/27/13 

Department of Health and Human Services logoDepartment of Health and Human Services Public Health Service Food and Drug Administration 

Denver District Office Bldg. 20-Denver Federal Center P.O. Box 25087 6th Avenue & Kipling Street Denver, Colorado 80225-0087 Telephone: 303-236-3000 FAX: 303-236-3100 

August 27, 2013 WARNING LETTER 

VIA UPS Overnight 

Mr. Juan Manuel Villegas Owner Rocky Ford Pet Foods 21693 Highway 50 East Rocky Ford, CO 81067 Ref. #: DEN-13-20-WL 

Dear Mr. Villegas: 

On February 25-27, 2013, the U.S. Food and Drug Administration (FDA) conducted an inspection of your rendering facility located at 21693 Highway 50 East, Rocky Ford, Colorado. This inspection revealed significant deviations from the requirements set forth in FDA regulations intended to reduce the risk of bovine spongiform encephalopathy (BSE) within the United States. These regulations are found in Title 21 of the Code of Federal Regulations (CFR), Section 589.2000 (21 CFR 589.2000), Animal Proteins Prohibited in Ruminant Feed, and Section 589.2001 (21 CFR 589.2001), Cattle Materials Prohibited in Animal Food or Feed to Prevent the Transmission of Bovine Spongiform Encephalopathy. These regulations address how renderers process (1) mammalian proteins prohibited from use in ruminant food or feed and (2) materials designated as “cattle materials prohibited in animal food or feed” (CMPAF) which are prohibited from use in animal food or feed. CMPAF include, but are not limited to: 

The brain and spinal cord of cattle 30 months of age or older; The entire carcass of cattle infected with BSE; and The entire carcass of cattle 30 months of age or older that have not been inspected and passed for human consumption if the brains and spinal cords were not removed or otherwise effectively excluded from animal feed. 

Your facility processes CMPAF. 

Your failure to follow certain requirements of these regulations, as described below, resulted in products manufactured and distributed by your facilities being adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 U.S.C. 342(a)(4)] and misbranded within the meaning of Section 403(f) of the Act, [21 U.S.C. 343(f)]. You can find the Act, and its implementing regulations on the Internet through links on the FDA’s web page at www.fda.gov. 

Our inspection revealed the following serious deviations from the regulations at your rendering facility: 

Failure to prevent the inclusion of cattle materials prohibited in animal feed (CMPAF) in animal feed or feed ingredients, as required by 21 CFR 589.2001(c)(1). Specifically, on February 25, 2013, our investigator observed that the unmarked CMPAF posterior sections of vertebral columns for two cows, identified by your firm as older than 30 months of age, were separated from the rest of the marked CMPAF material from those animals. The unmarked CMPAF material was then commingled with 18 additional posterior vertebral columns and placed in a trailer for shipment to another renderer for further processing and possible use in animal feed. 

You removed all 20 posterior vertebral columns from the trailer during the inspection and stated that you would dispose of them in a landfill. 

Failure to maintain adequate written procedures specifying how the process of removing the brain and spinal cord from cattle not inspected and passed for human consumption or 30 months of age or older is carried out, as required by 21 CFR 589.2001(c)(2)(ii). Specifically, your written procedure “Rocky Ford Ped [sic] Food Standard Operating Procedure for handling 30 month and older Beef and CMPAF Products” indicates that the head, vertebral column, and rib cage for cattle 30 months of age and older are kept in one piece. This written procedure is not consistent with actual operations observed at your firm on February 26, 2013. Our investigator observed that posterior vertebral columns from two cows 30 months of age or older were separated from the animals’ heads and anterior vertebral columns; the posterior sections were not marked as CMPAF material. Your written procedures fail to specify how, for animals 30 months of age or older, posterior vertebral columns separated from marked anterior vertebral columns would themselves be marked as CMPAF material. 

Failure to mark the CMPAF and products that contain or may contain CMPAF with an agent that can be readily detected on visual inspection, as required by 21 CFR 589.2001(c)(2)(v). Specifically, the posterior sections of vertebra columns from cattle identified by your firm as 30 months of age or older were separated from the head and anterior vertebral columns but then were not identified as CMPAF with an agent readily detectable on visual examination. Therefore, the CMPAF posterior vertebral columns were indistinguishable from the non-CMPAF posterior vertebral columns. 

Failure to label containers, including vehicles when used as containers, which contain CMPAF with the required statement, “Do not feed to animals,” as required by 21 CFR 589.2001(c)(2)(iv). Specifically, the dump truck and trailer used for storage and transport of CMPAF materials did not bear the statement “Do not feed to animals.” 

Failure to avoid cross-contamination once CMPAF have been separated from other cattle materials as required by 21 CFR 589.2001(c)(2)(iii). Specifically, both marked and unmarked CMPAF were observed to be stored on the floor of the processing area rather than in separate containers that adequately prevent contact with animal feed, animal feed ingredients, or equipment surfaces, 21 CFR 589.2001(c)(2)(iii)(B). As described in item #1 above, the unmarked materials were indistinguishable from non-CMPAF materials and could result in cross-contamination. 

This letter is not intended to serve as an all-inclusive list of violations at your facility. As a manufacturer of materials intended for animal feed use, you are responsible for ensuring your overall operation and the products you manufacture and distribute are in compliance with the law. You should take prompt action to correct these violations, and you should establish a system whereby violations do not recur. Failure to promptly correct these violations may result in regulatory action, such as seizure and/or injunction, without further notice. 

You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the timeframe within which the corrections will be completed. Please include copies of supporting documentation demonstrating that corrections have been made. 

Your written response should be sent to: U.S. Food and Drug Administration, P.O. Box 25087, 6th Ave. and Kipling St., DFC, Bldg 20, Denver, CO 80225-0087, Attn: Sarah A. Della Fave, Compliance Officer. If you have any questions about this letter, please contact Ms. Della Fave at (303) 236-3006. 

Sincerely, /S/ LaTonya Mitchell District Director 

 cc: Ronald K. Jones, D.V.M. Denver District Manager USDA/FSIS PO Box 25387 DFC, Bldg 45 Denver, CO 80225

 Laurel Hamling Colorado Department of Agriculture Feed Program 2331 W. 31st Avenue Denver, CO 80211



Product Details

Product Description: CalDensity Black Label, CalDensity White Label with HA, packaged in white plastic 5, 15, 25, 40, 60 lb pails with plastic liner and white plastic lid. 

Reason for Recall: During an FDA inspection it was found that the CalDensity Black label and CalDensity White Label with HA product containers did not include the precautionary statement 

DO NOT FEED TO CATTLE OR OTHER RUMINANTS

Product Quantity: 50,935 lbs 

Recall Number: V-209-2012 Code Information: 042009, 051009, 061209, 071509, 091009, 011510, 030310, 031610, 052610, 092410, 120110, 011211, 020111, 030911, 050111, 071111 & 090111. 

Classification: Class II Event Details

Event ID: 61880 

Voluntary / Mandated: Voluntary: 

Firm Initiated Product Type: Veterinary Initial Firm Notification of Consignee or Public: E-Mail Status: 

Terminated Distribution Pattern: 

Nationwide distribution: AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, KY, LA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, PA, SC, TX, UT, VA, WA & WV. 

No shipments were made to foreign countries including Canada. 

Recalling Firm: Process Managers LLC 485 Gawthrope Dr Winchester, KY 40391-8910 United States Recall Initiation Date: 1/6/2012 Center Classification Date: 9/7/2012 Date Terminated: 1/24/2014 



2012-2013

Product Details

Product Description: Regular Chicken 50# 

Ingredients: Corn, Wheat, Oats, Oyster shells, Medium Grit, CCC, ADS, Plant Protein Products, Animal Protein Products, Processed Grain By-Products, Roughage Products, Animal Fat procession with DHA, etc 

Reason for Recall: During an FDA sample collection, the firms 50# Regular Chicken Feed was found to contain mammalian protein. The label does not contain the warning statement. 

Product Quantity: 5400lbs (50lb bags) 

Recall Number: V-137-2013 Code Information: 8/6/2012 Classification: 

Class III Event Details

Event ID: 63743 

Voluntary / Mandated: 

Voluntary: 

Firm Initiated Product Type: 

Veterinary Initial Firm Notification of Consignee or Public: 

Other Status: Terminated 

Distribution Pattern: Midland MI area only. 

Recalling Firm: Cohoons Elevator Inc. 802 Townsend St Midland, MI 48640-5362 United States 

Recall Initiation Date: 11/21/2012 Center Classification Date: 2/8/2013 Date Terminated: 2/12/2013 



2007 MAD COW FEED BAN BREACH 10 MILLION POUNDS OF BANNED PRODUCT IN COMMERCE


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

###



ALABAMA MAD COW FEED IN COMMERCE 2006


RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II

______________________________ 

PRODUCT

a) CO-OP 32% Sinking Catfish, Recall # V-100-6;

b) Performance Sheep Pell W/Decox/A/N, medicated, net wt. 50 lbs, Recall # V-101-6;

c) Pro 40% Swine Conc Meal -- 50 lb, Recall # V-102-6;

d) CO-OP 32% Sinking Catfish Food Medicated, Recall # V-103-6;

e) "Big Jim’s" BBB Deer Ration, Big Buck Blend, Recall # V-104-6;

f) CO-OP 40% Hog Supplement Medicated Pelleted, Tylosin 100 grams/ton, 50 lb. bag, Recall # V-105-6;

g) Pig Starter Pell II, 18% W/MCDX Medicated 282020, Carbadox -- 0.0055%, Recall # V-106-6;

h) CO-OP STARTER-GROWER CRUMBLES, Complete Feed for Chickens from Hatch to 20 Weeks, Medicated, Bacitracin Methylene Disalicylate, 25 and 50 Lbs, Recall # V-107-6;

i) CO-OP LAYING PELLETS, Complete Feed for Laying Chickens, Recall # 108-6;

j) CO-OP LAYING CRUMBLES, Recall # V-109-6;

k) CO-OP QUAIL FLIGHT CONDITIONER MEDICATED, net wt 50 Lbs, Recall # V-110-6;

l) CO-OP QUAIL STARTER MEDICATED, Net Wt. 50 Lbs, Recall # V-111-6;

m) CO-OP QUAIL GROWER MEDICATED, 50 Lbs, Recall # V-112-6

CODE

Product manufactured from 02/01/2005 until 06/06/2006

RECALLING FIRM/MANUFACTURER

Alabama Farmers Cooperative, Inc., Decatur, AL, by telephone, fax, email and visit on June 9, 2006. FDA initiated recall is complete.

REASON

Animal and fish feeds which were possibly contaminated with ruminant based protein not labeled as "Do not feed to ruminants".

VOLUME OF PRODUCT IN COMMERCE

125 tons

DISTRIBUTION

AL and FL 

______________________________

PRODUCT

Bulk custom dairy feds manufactured from concentrates, Recall # V-113-6

CODE

All dairy feeds produced between 2/1/05 and 6/16/06 and containing H. J. Baker recalled feed products.

RECALLING FIRM/MANUFACTURER

Vita Plus Corp., Gagetown, MI, by visit beginning on June 21, 2006. Firm initiated recall is complete.

REASON

The feed was manufactured from materials that may have been contaminated with mammalian protein.

VOLUME OF PRODUCT IN COMMERCE

27,694,240 lbs

DISTRIBUTION

MI 

______________________________

PRODUCT

Bulk custom made dairy feed, Recall # V-114-6

CODE

None

RECALLING FIRM/MANUFACTURER

Burkmann Feeds LLC, Glasgow, KY, by letter on July 14, 2006. Firm initiated recall is ongoing.

REASON

Custom made feeds contain ingredient called Pro-Lak, which may contain ruminant derived meat and bone meal.

VOLUME OF PRODUCT IN COMMERCE

?????

DISTRIBUTION

KY

END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006

###


=====

PRODUCT 

Bulk Whole Barley, Recall # V-256-2009

CODE

No code or lot number.

RECALLING FIRM/MANUFACTURER

Mars Petcare US, Clinton, OK, by telephone on May 21, 2009. Firm initiated recall is complete.

REASON

Product may have contained prohibited materials without cautionary statement on the label.

VOLUME OF PRODUCT IN COMMERCE

208,820 pounds

DISTRIBUTION

TX

END OF ENFORCEMENT REPORT FOR AUGUST 26, 2009

###


Subject: MAD COW FEED RECALL KY VOLUME OF PRODUCT IN COMMERCE ????? 

Date: August 6, 2006 at 6:19 pm PST 

PRODUCT Bulk custom made dairy feed, Recall # V-114-6 

CODE None 

RECALLING FIRM/MANUFACTURER Burkmann Feeds LLC, Glasgow, KY, by letter on July 14, 2006. 

Firm initiated recall is ongoing. REASON Custom made feeds contain ingredient called Pro-Lak, which may contain ruminant derived meat and bone meal. 

VOLUME OF PRODUCT IN COMMERCE ????? 

DISTRIBUTION KY 

END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006

### 


MAD COW FEED RECALL USA EQUALS 10,878.06 TONS NATIONWIDE Sun Jul 16, 2006 09:22 71.248.128.67 

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II 

______________________________ 


PRODUCT a) PRO-LAK, bulk weight, Protein Concentrate for Lactating Dairy Animals, Recall # V-079-6; 

b) ProAmino II, FOR PREFRESH AND LACTATING COWS, net weight 50lb (22.6 kg), Recall # V-080-6; 

c) PRO-PAK, MARINE & ANIMAL PROTEIN CONCENTRATE FOR USE IN ANIMAL FEED, Recall # V-081-6; 

d) Feather Meal, Recall # V-082-6 

CODE a) Bulk b) None c) Bulk d) Bulk 

RECALLING FIRM/MANUFACTURER H. J. Baker & Bro., Inc., Albertville, AL, by telephone on June 15, 2006 and by press release on June 16, 2006. 

Firm initiated recall is ongoing.

 REASON Possible contamination of animal feeds with ruminent derived meat and bone meal. 

VOLUME OF PRODUCT IN COMMERCE 10,878.06 tons 

DISTRIBUTION Nationwide

END OF ENFORCEMENT REPORT FOR July 12, 2006

###


Subject: MAD COW FEED BAN WARNING LETTER ISSUED MAY 17, 2006 

Date: June 27, 2006 at 7:42 am PST Public Health Service Food and Drug Administration

New Orleans District 297 Plus Park Blvd. Nashville, TN 37217

Telephone: 615-781-5380 Fax: 615-781-5391

May 17, 2006

WARNING LETTER NO. 2006-NOL-06

FEDERAL EXPRESS OVERNIGHT DELIVERY

Mr. William Shirley, Jr., Owner Louisiana.DBA Riegel By-Products 2621 State Street Dallas, Texas 75204

Dear Mr. Shirley:

On February 12, 17, 21, and 22, 2006, a U.S. Food & Drug Administration (FDA) investigator inspected your rendering plant, located at 509 Fortson Street, Shreveport, Louisiana. The inspection revealed significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 [21 CFR 589.2000], Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). You failed to follow the requirements of this regulation; products being manufactured and distributed by your facility are misbranded within the meaning of Section 403(a)(1) [21 USC 343(a)(1)] of the Federal Food, Drug, and Cosmetic Act (the Act).

Our investigation found you failed to provide measures, including sufficient written procedures, to prevent commingling or cross-contamination and to maintain sufficient written procedures [21 CFR 589.2000(e)] because:

You failed to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissues into animal protein or feeds which may be used for ruminants. For example, your facility uses the same equipment to process mammalian and poultry tissues. However, you use only hot water to clean the cookers between processing tissues from each species. You do not clean the auger, hammer mill, grinder, and spouts after processing mammalian tissues.

You failed to maintain written procedures specifying the clean-out procedures or other means to prevent carryover of protein derived from mammalian tissues into feeds which may be used for ruminants.

As a result . the poultry meal you manufacture may contain protein derived from mammalian tissues prohibited in ruminant feed. Pursuant to 21 CFR 589.2000(e)(1)(i), any products containing or may contain protein derived from mammalian tissues must be labeled, "Do not feed to cattle or other ruminants." Since you failed to label a product which may contain protein derived from mammalian tissues with the required cautionary statement. the poultry meal is misbranded under Section 403(a)(1) [21 USC 343(a)(1)] of the Act.

This letter is not intended as an all-inclusive list of violations at your facility. As a manufacturer of materials intended for animal feed use, you are responsible for ensuring your overall operation and the products you manufacture and distribute are in compliance with the law. You should take prompt action to correct these violations, and you should establish a system whereby violations do not recur. Failure to promptly correct these violations may result in regulatory action, such as seizure and/or injunction, without further notice.

You should notify this office in writing within 15 working days of receiving this letter, outlining the specific steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating corrections have been made.

Your reply should be directed to Mark W. Rivero, Compliance Officer, U.S. Food and Drug Administration, 2424 Edenborn Avenue, Suite 410, Metairie, Louisiana 70001. If you have questions regarding any issue in this letter, please contact Mr. Rivero at (504) 219-8818, extension 103.

Sincerely,

/S

Carol S. Sanchez Acting District Director New Orleans District 


PLEASE NOTE, THE FDA URLS FOR OLD WARNING LETTERS ARE OBSOLETE AND DO NOT WORK IN MOST CASES. I LOOKED UP THE OLD ONE ABOVE AND FOUND IT, BUT HAVE NOT DONE THAT FOR THE OTHERS TO FOLLOW. THE DATA IS VALID THOUGH! 

Subject: MAD COW PROTEIN IN COMMERCE USA 2006 RECALL UPDATE 

From: "Terry S. Singeltary Sr." <[log in to unmask]> 

Reply-To: SAFETY <[log in to unmask]> 

Date: Mon, 9 Oct 2006 14:10:37 -0500 

Subject: MAD COW FEED RECALL USA SEPT 6, 2006 1961.72 TONS 

IN COMMERCE AL, TN, AND WV 

Date: September 6, 2006 at 7:58 am PST

PRODUCT a) EVSRC Custom dairy feed, Recall # V-130-6; b) Performance Chick Starter, Recall # V-131-6; c) Performance Quail Grower, Recall # V-132-6; d) Performance Pheasant Finisher, Recall # V-133-6. CODE None RECALLING FIRM/MANUFACTURER Donaldson & Hasenbein/dba J&R Feed Service, Inc., Cullman, AL, by telephone on June 23, 2006 and by letter dated July 19, 2006. 

Firm initiated recall is complete.

REASON Dairy and poultry feeds were possibly contaminated with ruminant based protein.

VOLUME OF PRODUCT IN COMMERCE 477.72 tons 

DISTRIBUTION AL

______________________________

snip...


 Subject: MAD COW FEED RECALLS ENFORCEMENT REPORT FOR AUGUST 9, 2006 KY, LA, MS, AL, GA, AND TN 11,000+ TONS 

Date: August 16, 2006 at 9:19 am PST RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II

______________________________

snip...

______________________________

PRODUCT Bulk custom dairy pre-mixes, Recall # V-120-6 

CODE None 

RECALLING FIRM/MANUFACTURER Ware Milling Inc., Houston, MS, by telephone on June 23, 2006. Firm initiated recall is complete.

REASON Possible contamination of dairy animal feeds with ruminant derived meat and bone meal.

VOLUME OF PRODUCT IN COMMERCE 350 tons DISTRIBUTION AL and MS

______________________________

PRODUCT 

a) Tucker Milling, LLC Tm 32% Sinking Fish Grower, #2680-Pellet, 50 lb. bags, Recall # V-121-6; 

b) Tucker Milling, LLC #31120, Game Bird Breeder Pellet, 50 lb. bags, Recall # V-122-6; 

c) Tucker Milling, LLC #31232 Game Bird Grower, 50 lb. bags, Recall # V-123-6; 

d) Tucker Milling, LLC 31227-Crumble, Game Bird Starter, BMD Medicated, 50 lb bags, Recall # V-124-6; 

e) Tucker Milling, LLC #31120, Game Bird Breeder, 50 lb bags, Recall # V-125-6; 

f) Tucker Milling, LLC #30230, 30 % Turkey Starter, 50 lb bags, Recall # V-126-6; 

g) Tucker Milling, LLC #30116, TM Broiler Finisher, 50 lb bags, Recall # V-127-6 

CODE All products manufactured from 02/01/2005 until 06/20/2006 

RECALLING FIRM/MANUFACTURER Recalling Firm: Tucker Milling LLC, Guntersville, AL, by telephone and visit on June 20, 2006, and by letter on June 23, 2006. Manufacturer: H. J. Baker and Brothers Inc., Stamford, CT. Firm initiated recall is ongoing.

REASON Poultry and fish feeds which were possibly contaminated with ruminant based protein were not labeled as "Do not feed to ruminants".

VOLUME OF PRODUCT IN COMMERCE 7,541-50 lb bags

DISTRIBUTION AL, GA, MS, and TN

END OF ENFORCEMENT REPORT FOR AUGUST 9, 2006

###


 Subject: MAD COW FEED RECALL AL AND FL VOLUME OF PRODUCT IN COMMERCE 125 TONS

Products manufactured from 02/01/2005 until 06/06/2006 

Date: August 6, 2006 at 6:16 pm PST 

PRODUCT 

a) CO-OP 32% Sinking Catfish, Recall # V-100-6; 

b) Performance Sheep Pell W/Decox/A/N, medicated, net wt. 50 lbs, Recall # V-101-6; 

c) Pro 40% Swine Conc Meal -- 50 lb, Recall # V-102-6; d) CO-OP 32% Sinking Catfish Food Medicated, Recall # V-103-6; 

e) "Big Jim's" BBB Deer Ration, Big Buck Blend, Recall # V-104-6; 

f) CO-OP 40% Hog Supplement Medicated Pelleted, Tylosin 100 grams/ton, 50 lb. bag, Recall # V-105-6; 

g) Pig Starter Pell II, 18% W/MCDX Medicated 282020, Carbadox -- 0.0055%, Recall # V-106-6; 

h) CO-OP STARTER-GROWER CRUMBLES, Complete Feed for Chickens from Hatch to 20 Weeks, Medicated, Bacitracin Methylene Disalicylate, 25 and 50 Lbs, Recall # V-107-6; 

i) CO-OP LAYING PELLETS, Complete Feed for Laying Chickens, Recall # 108-6; 

j) CO-OP LAYING CRUMBLES, Recall # V-109-6; 

k) CO-OP QUAIL FLIGHT CONDITIONER MEDICATED, net wt 50 Lbs, Recall # V-110-6; 

l) CO-OP QUAIL STARTER MEDICATED, Net Wt. 50 Lbs, Recall # V-111-6; 

m) CO-OP QUAIL GROWER MEDICATED, 50 Lbs, Recall # V-112-6 

CODE 

Product manufactured from 02/01/2005 until 06/06/2006 RECALLING FIRM/MANUFACTURER Alabama Farmers Cooperative, Inc., Decatur, AL, by telephone, fax, email and visit on June 9, 2006. FDA initiated recall is complete.

REASON Animal and fish feeds which were possibly contaminated with ruminant based protein not labeled as "Do not feed to ruminants".

VOLUME OF PRODUCT IN COMMERCE 125 tons DISTRIBUTION AL and FL

END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006

###


 MAD COW FEED RECALL USA EQUALS 10,878.06 TONS NATIONWIDE Sun Jul 16, 2006 09:22 71.248.128.67

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II

______________________________

PRODUCT 

a) PRO-LAK, bulk weight, Protein Concentrate for Lactating Dairy Animals, Recall # V-079-6; 

b) ProAmino II, FOR PREFRESH AND LACTATING COWS, net weight 50lb (22.6 kg), Recall # V-080-6; 

c) PRO-PAK, MARINE & ANIMAL PROTEIN CONCENTRATE FOR USE IN ANIMAL FEED, Recall # V-081-6; 

d) Feather Meal, Recall # V-082-6 

CODE a) Bulk b) None c) Bulk d) Bulk 

RECALLING FIRM/MANUFACTURER H. J. Baker & Bro., Inc., Albertville, AL, by telephone on June 15, 2006 and by press release on June 16, 2006. 

Firm initiated recall is ongoing.

REASON Possible contamination of animal feeds with ruminent derived meat and bone meal.

VOLUME OF PRODUCT IN COMMERCE 10,878.06 tons

DISTRIBUTION Nationwide

END OF ENFORCEMENT REPORT FOR July 12, 2006

###


Office of Inspector General Semiannual Report to Congress FY 2007 - 2nd Half

Two Texas Companies Sentenced and Fined for Misbranding Meat Products In April 2007, two closely held and related Texas companies pled guilty in Federal court and were sentenced to 12 months of probation and ordered to pay $10,250 in fines for misbranding meat products. One of the companies sold adulterated meat products to a retail store in New Mexico. Additionally, portions of the invoices failed to properly and consistently identify the meat products as being from cattle more than 30 months old at time of slaughter. This information is required to be disclosed because of bovine spongiform encephalopathy (BSE, or "mad cow disease") concerns. No adulterated meat reached consumers.


 Saturday, August 29, 2009

FOIA REQUEST FEED RECALL 2009 Product may have contained prohibited materials Bulk Whole Barley, Recall # V-256-2009


 Friday, September 4, 2009

FOIA REQUEST ON FEED RECALL PRODUCT 429,128 lbs. feed for ruminant animals may have been contaminated with prohibited material Recall # V-258-2009


Thursday, March 19, 2009

MILLIONS AND MILLIONS OF POUNDS OF MAD COW FEED IN COMMERCE USA WITH ONGOING 12 YEARS OF DENIAL NOW, WHY IN THE WORLD DO WE TO TALK ABOUT THIS ANYMORE $$$




*** PLEASE SEE THIS URGENT UPDATE ON CWD AND FEED ANIMAL PROTEIN ***

cwd to pig, orally ;

Research Project: TRANSMISSION, DIFFERENTIATION, AND PATHOBIOLOGY OF TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES

Location: Virus and Prion Research

Title: Disease-associated prion protein detected in lymphoid tissues from pigs challenged with the agent of chronic wasting disease

Author item Moore, Sarah item Kunkle, Robert item Kondru, Naveen item Manne, Sireesha item Smith, Jodi item Kanthasamy, Anumantha item West Greenlee, M item Greenlee, Justin

Submitted to: Prion Publication Type: Abstract Only Publication Acceptance Date: 3/15/2017 Publication Date: N/A Citation: N/A Interpretive Summary:

Technical Abstract: Aims: Chronic wasting disease (CWD) is a naturally-occurring, fatal neurodegenerative disease of cervids. We previously demonstrated that disease-associated prion protein (PrPSc) can be detected in the brain and retina from pigs challenged intracranially or orally with the CWD agent. In that study, neurological signs consistent with prion disease were observed only in one pig: an intracranially challenged pig that was euthanized at 64 months post-challenge. The purpose of this study was to use an antigen-capture immunoassay (EIA) and real-time quaking-induced conversion (QuIC) to determine whether PrPSc is present in lymphoid tissues from pigs challenged with the CWD agent.

Methods: At two months of age, crossbred pigs were challenged by the intracranial route (n=20), oral route (n=19), or were left unchallenged (n=9). At approximately 6 months of age, the time at which commercial pigs reach market weight, half of the pigs in each group were culled (<6 month challenge groups). The remaining pigs (>6 month challenge groups) were allowed to incubate for up to 73 months post challenge (mpc). The retropharyngeal lymph node (RPLN) was screened for the presence of PrPSc by EIA and immunohistochemistry (IHC). The RPLN, palatine tonsil, and mesenteric lymph node (MLN) from 6-7 pigs per challenge group were also tested using EIA and QuIC.

Results: PrPSc was not detected by EIA and IHC in any RPLNs. All tonsils and MLNs were negative by IHC, though the MLN from one pig in the oral <6 month group was positive by EIA. PrPSc was detected by QuIC in at least one of the lymphoid tissues examined in 5/6 pigs in the intracranial <6 months group, 6/7 intracranial >6 months group, 5/6 pigs in the oral <6 months group, and 4/6 oral >6 months group. Overall, the MLN was positive in 14/19 (74%) of samples examined, the RPLN in 8/18 (44%), and the tonsil in 10/25 (40%). Conclusions:

This study demonstrates that PrPSc accumulates in lymphoid tissues from pigs challenged intracranially or orally with the CWD agent, and can be detected as early as 4 months after challenge.

CWD-infected pigs rarely develop clinical disease and if they do, they do so after a long incubation period. This raises the possibility that CWD-infected pigs could shed prions into their environment long before they develop clinical disease.

Furthermore, lymphoid tissues from CWD-infected pigs could present a potential source of CWD infectivity in the animal and human food chains.



CONFIDENTIAL


EXPERIMENTAL PORCINE SPONGIFORM ENCEPHALOPATHY

While this clearly is a cause for concern we should not jump to the conclusion that this means that pigs will necessarily be infected by bone and meat meal fed by the oral route as is the case with cattle. ...



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.


 
Our records show that while some use is made of porcine materials in medicinal products, the only products which would appear to be in a hypothetically ''higher risk'' area are the adrenocorticotrophic hormone for which the source material comes from outside the United Kingdom, namely America China Sweden France and Germany. The products are manufactured by Ferring and Armour. A further product, ''Zenoderm Corium implant'' manufactured by Ethicon, makes use of porcine skin - which is not considered to be a ''high risk'' tissue, but one of its uses is described in the data sheet as ''in dural replacement''. This product is sourced from the United Kingdom.....


 
snip...see much more here ;


WEDNESDAY, APRIL 05, 2017

Disease-associated prion protein detected in lymphoid tissues from pigs challenged with the agent of chronic wasting disease



MONDAY, AUGUST 14, 2017 

Experimental transmission of the chronic wasting disease agent to swine after oral or intracranial inoculation




TUESDAY, APRIL 18, 2017 

EXTREME USA FDA PART 589 TSE PRION FEED LOOP HOLE STILL EXIST, AND PRICE OF POKER GOES UP



FRIDAY, NOVEMBER 3, 2017

BSE MAD COW TSE PRION DISEASE PET FOOD FEED IN COMMERCE INDUSTRY VS TERRY S. SINGELTARY Sr. A REVIEW

''I have a neighbor who is a dairy farmer. He tells me that he knows of several farmers who feed their cattle expired dog food. These farmers are unaware of any dangers posed to their cattle from the pet food contents. For these farmers, the pet food is just another source of protein.''

IN CONFIDENCE



SATURDAY, NOVEMBER 4, 2017 

FDA 589.2000, Section 21 C.F.R. Animal Proteins Prohibited in Ruminant Feed WARNING Letters and FEED MILL VIOLATIONS OBSERVATIONS 2017 to 2006



OFFICIAL REPORT U.K. GOVERNMENT DEFRA

What is the risk of chronic wasting disease being introduced into Great Britain? A Qualitative Risk Assessment October 2012

Several different animal feed products are imported into GB from North America. These include processed pet foods and consignments of unfinished feed ingredients for use in animal feed. The amount of imported feed, including pet food, that contains cervid protein is unknown and identified as a significant data gap. As non-ruminant animal feed may be produced with cervid protein (but not from positive CWD animals) in the United States (US), there is a greater than negligible risk that feed with cervid protein is imported from North America into GB. There is, however, uncertainty associated with this estimate.

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...

What is the risk of chronic wasting disease being introduced into Great Britain? A Qualitative Risk Assessment October 2012


Thursday, April 07, 2016

What is the risk of chronic wasting disease being introduced into Great Britain? An updated Qualitative Risk Assessment March 2016


TUESDAY, OCTOBER 17, 2017 

EFSA asked to review risk from processed animal proteins in feed PIG PAP and CWD TSE Prion Oral Transmission




THURSDAY, JULY 13, 2017 

EFSA BSE Sixty cases of mad cow disease since 2001 breached feed ban likely the cause 

Scientists investigate origin of isolated BSE cases



FRIDAY, OCTOBER 06, 2017 

Canada and USA Scrapie BSE TSE Prion Update October 5 2017



WEDNESDAY, OCTOBER 4, 2017 

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of the United States of America (USA) a review 2017



O.05: Transmission of prions to primates after extended silent incubation periods: Implications for BSE and scrapie risk assessment in human populations
 
Emmanuel Comoy, Jacqueline Mikol, Valerie Durand, Sophie Luccantoni, Evelyne Correia, Nathalie Lescoutra, Capucine Dehen, and Jean-Philippe Deslys Atomic Energy Commission; Fontenay-aux-Roses, France
 
Prion diseases (PD) are the unique neurodegenerative proteinopathies reputed to be transmissible under field conditions since decades. The transmission of Bovine Spongiform Encephalopathy (BSE) to humans evidenced that an animal PD might be zoonotic under appropriate conditions. Contrarily, in the absence of obvious (epidemiological or experimental) elements supporting a transmission or genetic predispositions, PD, like the other proteinopathies, are reputed to occur spontaneously (atpical animal prion strains, sporadic CJD summing 80% of human prion cases). Non-human primate models provided the first evidences supporting the transmissibiity of human prion strains and the zoonotic potential of BSE. Among them, cynomolgus macaques brought major information for BSE risk assessment for human health (Chen, 2014), according to their phylogenetic proximity to humans and extended lifetime. We used this model to assess the zoonotic potential of other animal PD from bovine, ovine and cervid origins even after very long silent incubation periods.
 
*** We recently observed the direct transmission of a natural classical scrapie isolate to macaque after a 10-year silent incubation period,
 
***with features similar to some reported for human cases of sporadic CJD, albeit requiring fourfold long incubation than BSE. Scrapie, as recently evoked in humanized mice (Cassard, 2014),
 
***is the third potentially zoonotic PD (with BSE and L-type BSE),
 
***thus questioning the origin of human sporadic cases. 

We will present an updated panorama of our different transmission studies and discuss the implications of such extended incubation periods on risk assessment of animal PD for human health.
 
===============
 
***thus questioning the origin of human sporadic cases***
 
===============
 
***our findings suggest that possible transmission risk of H-type BSE to sheep and human. Bioassay will be required to determine whether the PMCA products are infectious to these animals.
 
==============
 
 
 Transmission data also revealed that several scrapie prions propagate in HuPrP-Tg mice with efficiency comparable to that of cattle BSE. While the efficiency of transmission at primary passage was low, subsequent passages resulted in a highly virulent prion disease in both Met129 and Val129 mice. Transmission of the different scrapie isolates in these mice leads to the emergence of prion strain phenotypes that showed similar characteristics to those displayed by MM1 or VV2 sCJD prion. These results demonstrate that scrapie prions have a zoonotic potential and raise new questions about the possible link between animal and human prions.
 
 
 
Saturday, April 23, 2016
 
Scrapie ZOONOSIS PRION CONFERENCE TOKYO 2016
 
*** SCRAPIE WS-01: Prion diseases in animals and zoonotic potential 2016 ***
 
Prion. 10:S15-S21. 2016 ISSN: 1933-6896 printl 1933-690X
 


SUNDAY, JULY 30, 2017 PRION2017 Low levels of classical BSE infectivity in rendered fat tissue P169 Low levels of classical BSE infectivity in rendered fat tissue

Dr. Christine Fast1, Dr. Markus Keller2, Dr. Ute Ziegler3, Prof. Dr. Martin Groschup4 1Friedrich-Loeffler-Institut, Greifswald, Germany, 2Friedrich-Loeffler-Institut, Greifswald, Germany, 3Friedrich-Loeffler-Institut, Greifswald, Germany, 4Friedrich-Loeffler-Institut, Greifswald, Germany

Aims: Specified Risk Materials (SRM) are the animal tissues potentially containing the highest levels of Bovine Spongiform Encephalopathy (BSE) prions; and their removal is the most important consumer protection measure against BSE. BSE infectivity in the mesentery fat is most likely associated with embedded nervous tissue. To date, it is unclear if contamination of the rendered fat could have occurred during tallow production at a slaughterhouse.

Methods: Samples were taken from five cattle originating from the German BSE pathogenesis study. Two animals were at preclinical, one at late preclinical and one animal at clinical stage of disease; one control animal was included. For all cattle, mouse bioassay results for the celiac and mesenteric ganglion complex (CMGC) were generated previously, showing either no, mild, moderate or substantial infectivity loads. Fat was rendered from CMGC samples embedded in mesentery fat by incubating for 20 minutes at 95°C, according to standard tallow production methods. Subsequently, the melted fat was 1:5 diluted in physiological saline and thoroughly vortexed. The liquid fat was cleaned by a short centrifugation at 10.000 rpm. Finally, 7-12 bovine prion protein overexpressing transgenic mice (Tgbov XV) were i.c. inoculated with 25-30 μl of the supernatant. Mice were sacrificed after 730 days or when showing clinical symptoms and mouse brains were subsequently examined by biochemical and immunohistochemical methods.

Results: Neither the control and the preclinical nor the late preclinical animals showed signs of infectivity in mouse bioassay of the fat samples after up to 730 days p.i. In contrast, low levels of infectivity were detected in the fat of the clinical animal as one mouse displayed a clear accumulation of pathological prion protein in the brain after an incubation period of 598 days p.i.

Conclusions: Our results clearly indicate the potential contamination of melted mesenteric fat by embedded nervous structures during standard tallow production. However, the BSE infectivity level was weak and detectable only in the fat rendered from one sample with documented high infectivity load in the ganglion itself (Kaatz et al. 2012). Albeit, this study is not representative as only one clinical animal was included, it provides a proof of principle. A broader examination would allow a better insight into temporal and spatial distribution pattern of BSE infectivity in rendered fat tissues of different origins.Such estimates have a critical role in qualitative and quantitative risk assessments and in providing advice on the designation and removal of certain SRM tissues.



--->CHRONIC WASTING DISEASE CWD TSE PRION REALITY ON THE REAL THREAT OF ZOONOSIS ZOONOTIC DISEASE<---

2017

Subject: ***CDC Now Recommends Strongly consider having the deer or elk tested for CWD before you eat the meat

CDC Now Recommends Strongly consider having the deer or elk tested for CWD before you eat the meat 

Chronic Wasting Disease (CWD) 

Prevention 

If CWD could spread to people, it would most likely be through eating of infected deer and elk. In a 2006-2007 CDC survey of U.S. residents, nearly 20 percent of those surveyed said they had hunted deer or elk and more than two-thirds said they had eaten venison or elk meat. However, to date, no CWD infections have been reported in people. 

Hunters must consider many factors when determining whether to eat meat from deer and elk harvested from areas with CWD, including the level of risk they are willing to accept. Hunters harvesting wild deer and elk from areas with reported CWD should check state wildlife and public health guidance to see whether testing of animals is recommended or required in a given state or region. In areas where CWD is known to be present, CDC recommends that hunters strongly consider having those animals tested before eating the meat. 

Tests for CWD are monitoring tools that some state wildlife officials use to look at the rates of CWD in certain animal populations. Testing may not be available in every state, and states may use these tests in different ways. A negative test result does not guarantee that an individual animal is not infected with CWD, but it does make it considerably less likely and may reduce your risk of exposure to CWD. 

To be as safe as possible and decrease their potential risk of exposure to CWD, hunters should take the following steps when hunting in areas with CWD: 

Do not shoot, handle or eat meat from deer and elk that look sick or are acting strangely or are found dead (road-kill). When field-dressing a deer: Wear latex or rubber gloves when dressing the animal or handling the meat. Minimize how much you handle the organs of the animal, particularly the brain or spinal cord tissues. Do not use household knives or other kitchen utensils for field dressing. Check state wildlife and public health guidance to see whether testing of animals is recommended or required. Recommendations vary by state, but information about testing is available from many state wildlife agencies. Strongly consider having the deer or elk tested for CWD before you eat the meat. If you have your deer or elk commercially processed, consider asking that your animal be processed individually to avoid mixing meat from multiple animals. If your animal tests positive for CWD, do not eat meat from that animal. The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service regulates commercially farmed deer and elk. The agency operates a national CWD herd certification program. As part of the voluntary program, states and individual herd owners agree to meet requirements meant to decrease the risk of CWD in their herds. Privately owned herds that do not participate in the herd certification program may be at increased risk for CWD. 

Page last reviewed: August 17, 2017 Page last updated: August 17, 2017 Content source: Centers for Disease Control and Prevention National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) Division of High-Consequence Pathogens and Pathology (DHCPP) 


 > However, to date, no CWD infections have been reported in people. 

key word here is 'reported'. science has shown that CWD in humans will look like sporadic CJD. SO, how can one assume that CWD has not already transmitted to humans? they can't, and it's as simple as that. from all recorded science to date, CWD has already transmitted to humans, and it's being misdiagnosed as sporadic CJD. ...terry 

LOOKING FOR CWD IN HUMANS AS nvCJD or as an ATYPICAL CJD, LOOKING IN ALL THE WRONG PLACES $$$ 

*** These results would seem to suggest that CWD does indeed have zoonotic potential, at least as judged by the compatibility of CWD prions and their human PrPC target. Furthermore, extrapolation from this simple in vitro assay suggests that if zoonotic CWD occurred, it would most likely effect those of the PRNP codon 129-MM genotype and that the PrPres type would be similar to that found in the most common subtype of sCJD (MM1).*** 



Molecular Barriers to Zoonotic Transmission of Prions 

*** chronic wasting disease, there was no absolute barrier to conversion of the human prion protein. 

*** Furthermore, the form of human PrPres produced in this in vitro assay when seeded with CWD, resembles that found in the most common human prion disease, namely sCJD of the MM1 subtype. 


TUESDAY, SEPTEMBER 12, 2017 

CDC Now Recommends Strongly consider having the deer or elk tested for CWD before you eat the meat 


Prion 2017 Conference Abstracts CWD

 2017 PRION CONFERENCE 

First evidence of intracranial and peroral transmission of Chronic Wasting Disease (CWD) into Cynomolgus macaques: a work in progress 

Stefanie Czub1, Walter Schulz-Schaeffer2, Christiane Stahl-Hennig3, Michael Beekes4, Hermann Schaetzl5 and Dirk Motzkus6 1 

University of Calgary Faculty of Veterinary Medicine/Canadian Food Inspection Agency; 2Universitatsklinikum des Saarlandes und Medizinische Fakultat der Universitat des Saarlandes; 3 Deutsches Primaten Zentrum/Goettingen; 4 Robert-Koch-Institut Berlin; 5 University of Calgary Faculty of Veterinary Medicine; 6 presently: Boehringer Ingelheim Veterinary Research Center; previously: Deutsches Primaten Zentrum/Goettingen 

This is a progress report of a project which started in 2009. 21 cynomolgus macaques were challenged with characterized CWD material from white-tailed deer (WTD) or elk by intracerebral (ic), oral, and skin exposure routes. Additional blood transfusion experiments are supposed to assess the CWD contamination risk of human blood product. Challenge materials originated from symptomatic cervids for ic, skin scarification and partially per oral routes (WTD brain). Challenge material for feeding of muscle derived from preclinical WTD and from preclinical macaques for blood transfusion experiments. We have confirmed that the CWD challenge material contained at least two different CWD agents (brain material) as well as CWD prions in muscle-associated nerves. 

Here we present first data on a group of animals either challenged ic with steel wires or per orally and sacrificed with incubation times ranging from 4.5 to 6.9 years at postmortem. Three animals displayed signs of mild clinical disease, including anxiety, apathy, ataxia and/or tremor. In four animals wasting was observed, two of those had confirmed diabetes. All animals have variable signs of prion neuropathology in spinal cords and brains and by supersensitive IHC, reaction was detected in spinal cord segments of all animals. Protein misfolding cyclic amplification (PMCA), real-time quaking-induced conversion (RT-QuiC) and PET-blot assays to further substantiate these findings are on the way, as well as bioassays in bank voles and transgenic mice. 

At present, a total of 10 animals are sacrificed and read-outs are ongoing. Preclinical incubation of the remaining macaques covers a range from 6.4 to 7.10 years. Based on the species barrier and an incubation time of > 5 years for BSE in macaques and about 10 years for scrapie in macaques, we expected an onset of clinical disease beyond 6 years post inoculation. 

PRION 2017 DECIPHERING NEURODEGENERATIVE DISORDERS 

Subject: PRION 2017 CONFERENCE DECIPHERING NEURODEGENERATIVE DISORDERS VIDEO 

PRION 2017 CONFERENCE DECIPHERING NEURODEGENERATIVE DISORDERS 

*** PRION 2017 CONFERENCE VIDEO 



 TUESDAY, JUNE 13, 2017

PRION 2017 CONFERENCE ABSTRACT 

First evidence of intracranial and peroral transmission of Chronic Wasting Disease (CWD) into Cynomolgus macaques: a work in progress


TUESDAY, JULY 04, 2017

*** PRION 2017 CONFERENCE ABSTRACTS ON CHRONIC WASTING DISEASE CWD TSE PRION ***


TUESDAY, JUNE 13, 2017

PRION 2017 CONFERENCE ABSTRACT Chronic Wasting Disease in European moose is associated with PrPSc features different from North American CWD


Wednesday, May 24, 2017 

PRION2017 CONFERENCE VIDEO UPDATE 23 – 26 May 2017 Edinburgh UPDATE 1 


SATURDAY, JULY 29, 2017 

Risk Advisory Opinion: Potential Human Health Risks from Chronic Wasting Disease CFIA, PHAC, HC (HPFB and FNIHB), INAC, Parks Canada, ECCC and AAFC 


Prion Infectivity in Fat of Deer with Chronic Wasting Disease▿ 

Brent Race#, Kimberly Meade-White#, Richard Race and Bruce Chesebro* + Author Affiliations

Rocky Mountain Laboratories, 903 South 4th Street, Hamilton, Montana 59840 Next Section ABSTRACT

Chronic wasting disease (CWD) is a neurodegenerative prion disease of cervids. Some animal prion diseases, such as bovine spongiform encephalopathy, can infect humans; however, human susceptibility to CWD is unknown. In ruminants, prion infectivity is found in central nervous system and lymphoid tissues, with smaller amounts in intestine and muscle. In mice, prion infectivity was recently detected in fat. Since ruminant fat is consumed by humans and fed to animals, we determined infectivity titers in fat from two CWD-infected deer. Deer fat devoid of muscle contained low levels of CWD infectivity and might be a risk factor for prion infection of other species.


Prions in Skeletal Muscles of Deer with Chronic Wasting Disease 

Rachel C. Angers1,*, Shawn R. Browning1,*,†, Tanya S. Seward2, Christina J. Sigurdson4,‡, Michael W. Miller5, Edward A. Hoover4, Glenn C. Telling1,2,3,§ ↵* These authors contributed equally to this work. ↵† Present address: Department of Infectology, Scripps Research Institute, 5353 Parkside Drive, RF-2, Jupiter, FL 33458, USA. ↵‡ Present address: Institute of Neuropathology, University of Zurich, Schmelzbergstrasse 12, 8091 Zurich, Switzerland. + See all authors and affiliations Science 24 Feb 2006: Vol. 311, Issue 5764, pp. 1117 DOI: 10.1126/science.1122864 Article Figures & Data Info & Metrics eLetters PDF You are currently viewing the abstract.

View Full Text

Abstract

The emergence of chronic wasting disease (CWD) in deer and elk in an increasingly wide geographic area, as well as the interspecies transmission of bovine spongiform encephalopathy to humans in the form of variant Creutzfeldt Jakob disease, have raised concerns about the zoonotic potential of CWD. Because meat consumption is the most likely means of exposure, it is important to determine whether skeletal muscle of diseased cervids contains prion infectivity. Here bioassays in transgenic mice expressing cervid prion protein revealed the presence of infectious prions in skeletal muscles of CWD-infected deer, demonstrating that humans consuming or handling meat from CWD-infected deer are at risk to prion exposure.



*** WDA 2016 NEW YORK *** 

 We found that CWD adapts to a new host more readily than BSE and that human PrP was unexpectedly prone to misfolding by CWD prions. In addition, we investigated the role of specific regions of the bovine, deer and human PrP protein in resistance to conversion by prions from another species. We have concluded that the human protein has a region that confers unusual susceptibility to conversion by CWD prions. 

 Student Presentations Session 2 

 The species barriers and public health threat of CWD and BSE prions 

 Ms. Kristen Davenport1, Dr. Davin Henderson1, Dr. Candace Mathiason1, Dr. Edward Hoover1 1Colorado State University 

 Chronic wasting disease (CWD) is spreading rapidly through cervid populations in the USA. Bovine spongiform encephalopathy (BSE, mad cow disease) arose in the 1980s because cattle were fed recycled animal protein. These and other prion diseases are caused by abnormal folding of the normal prion protein (PrP) into a disease causing form (PrPd), which is pathogenic to nervous system cells and can cause subsequent PrP to misfold. CWD spreads among cervids very efficiently, but it has not yet infected humans. On the other hand, BSE was spread only when cattle consumed infected bovine or ovine tissue, but did infect humans and other species. The objective of this research is to understand the role of PrP structure in cross-species infection by CWD and BSE. To study the propensity of each species’ PrP to be induced to misfold by the presence of PrPd from verious species, we have used an in vitro system that permits detection of PrPd in real-time. We measured the conversion efficiency of various combinations of PrPd seeds and PrP substrate combinations. We observed the cross-species behavior of CWD and BSE, in addition to feline-adapted CWD and BSE. We found that CWD adapts to a new host more readily than BSE and that human PrP was unexpectedly prone to misfolding by CWD prions. In addition, we investigated the role of specific regions of the bovine, deer and human PrP protein in resistance to conversion by prions from another species. We have concluded that the human protein has a region that confers unusual susceptibility to conversion by CWD prions. CWD is unique among prion diseases in its rapid spread in natural populations. BSE prions are essentially unaltered upon passage to a new species, while CWD adapts to the new species. This adaptation has consequences for surveillance of humans exposed to CWD. 

 Wildlife Disease Risk Communication Research Contributes to Wildlife Trust Administration Exploring perceptions about chronic wasting disease risks among wildlife and agriculture professionals and stakeholders 


From: TSS (216-119-163-189.ipset45.wt.net) 

Subject: CWD aka MAD DEER/ELK TO HUMANS ??? 

Date: September 30, 2002 at 7:06 am PST 

From: "Belay, Ermias" 

To: Cc: "Race, Richard (NIH)" ; ; "Belay, Ermias" 

Sent: Monday, September 30, 2002 9:22 AM 

Subject: RE: TO CDC AND NIH - PUB MED- 3 MORE DEATHS - CWD - YOUNG HUNTERS 

Dear Sir/Madam, 

In the Archives of Neurology you quoted (the abstract of which was attached to your email), we did not say CWD in humans will present like variant CJD. That assumption would be wrong. I encourage you to read the whole article and call me if you have questions or need more clarification (phone: 404-639-3091). Also, we do not claim that "no-one has ever been infected with prion disease from eating venison." Our conclusion stating that we found no strong evidence of CWD transmission to humans in the article you quoted or in any other forum is limited to the patients we investigated. 

Ermias Belay, M.D. Centers for Disease Control and Prevention 

-----Original Message----- 

From: Sent: Sunday, September 29, 2002 10:15 AM 


Subject: TO CDC AND NIH - PUB MED- 3 MORE DEATHS - CWD - YOUNG HUNTERS 

Sunday, November 10, 2002 6:26 PM ......snip........end..............TSS 

Thursday, April 03, 2008 

A prion disease of cervids: Chronic wasting disease 2008 1: Vet Res. 2008 Apr 3;39(4):41 A prion disease of cervids: Chronic wasting disease Sigurdson CJ. 

snip... 

*** twenty-seven CJD patients who regularly consumed venison were reported to the Surveillance Center***, 

snip... full text ; 


I urge everyone to watch this video closely...terry 

*** you can see video here and interview with Jeff's Mom, and scientist telling you to test everything and potential risk factors for humans ***


*** 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. 



BSE INQUIRY

*** The association between venison eating and risk of CJD shows similar pattern, with regular venison eating associated with a 9 FOLD INCREASE IN RISK OF CJD (p = 0.04). *** 

*** The association between venison eating and risk of CJD shows similar pattern, with regular venison eating associated with a 9 FOLD INCREASE IN RISK OF CJD (p = 0.04). *** 

*** The association between venison eating and risk of CJD shows similar pattern, with regular venison eating associated with a 9 FOLD INCREASE IN RISK OF CJD (p = 0.04). 

*** There is some evidence that risk of CJD INCREASES WITH INCREASING FREQUENCY OF LAMB EATING (p = 0.02). 

The evidence for such an association between beef eating and CJD is weaker (p = 0.14). When only controls for whom a relative was interviewed are included, this evidence becomes a little STRONGER (p = 0.08). 

snip... 

It was found that when veal was included in the model with another exposure, the association between veal and CJD remained statistically significant (p = < 0.05 for all exposures), while the other exposures ceased to be statistically significant (p = > 0.05). 

snip... 

In conclusion, an analysis of dietary histories revealed statistical associations between various meats/animal products and INCREASED RISK OF CJD. When some account was taken of possible confounding, the association between VEAL EATING AND RISK OF CJD EMERGED AS THE STRONGEST OF THESE ASSOCIATIONS STATISTICALLY. ... 

snip... 

***In the study in the USA, a range of foodstuffs were associated with an increased risk of CJD, including liver consumption which was associated with an apparent SIX-FOLD INCREASE IN THE RISK OF CJD. 

By comparing the data from 3 studies in relation to this particular dietary factor, the risk of liver consumption became non-significant with an odds ratio of 1.2 (PERSONAL COMMUNICATION, PROFESSOR A. HOFMAN. ERASMUS UNIVERSITY, ROTTERDAM). (???...TSS) 

snip...see full report ;


you can see more evidence here ;


*** After a natural route of exposure, 100% of WTD were susceptible to scrapie.

PO-039: A comparison of scrapie and chronic wasting disease in white-tailed deer
 
Justin Greenlee, Jodi Smith, Eric Nicholson US Dept. Agriculture; Agricultural Research Service, National Animal Disease Center; Ames, IA USA
 
 
White-tailed deer are susceptible to the agent of sheep scrapie by intracerebral inoculation
 
snip...
 
It is unlikely that CWD will be eradicated from free-ranging cervids, and the disease is likely to continue to spread geographically [10]. However, the potential that white-tailed deer may be susceptible to sheep scrapie by a natural route presents an additional confounding factor to halting the spread of CWD. This leads to the additional speculations that
 
1) infected deer could serve as a reservoir to infect sheep with scrapie offering challenges to scrapie eradication efforts and
 
2) CWD spread need not remain geographically confined to current endemic areas, but could occur anywhere that sheep with scrapie and susceptible cervids cohabitate.
 
This work demonstrates for the first time that white-tailed deer are susceptible to sheep scrapie by intracerebral inoculation with a high attack rate and that the disease that results has similarities to CWD. These experiments will be repeated with a more natural route of inoculation to determine the likelihood of the potential transmission of sheep scrapie to white-tailed deer. If scrapie were to occur in white-tailed deer, results of this study indicate that it would be detected as a TSE, but may be difficult to differentiate from CWD without in-depth biochemical analysis.
 
 
 
2012
 
PO-039: A comparison of scrapie and chronic wasting disease in white-tailed deer
 
Justin Greenlee, Jodi Smith, Eric Nicholson US Dept. Agriculture; Agricultural Research Service, National Animal Disease Center; Ames, IA USA
 
snip...
 
The results of this study suggest that there are many similarities in the manifestation of CWD and scrapie in WTD after IC inoculation including early and widespread presence of PrPSc in lymphoid tissues, clinical signs of depression and weight loss progressing to wasting, and an incubation time of 21-23 months. Moreover, western blots (WB) done on brain material from the obex region have a molecular profile similar to CWD and distinct from tissues of the cerebrum or the scrapie inoculum. However, results of microscopic and IHC examination indicate that there are differences between the lesions expected in CWD and those that occur in deer with scrapie: amyloid plaques were not noted in any sections of brain examined from these deer and the pattern of immunoreactivity by IHC was diffuse rather than plaque-like.
 
*** After a natural route of exposure, 100% of WTD were susceptible to scrapie.
 
Deer developed clinical signs of wasting and mental depression and were necropsied from 28 to 33 months PI. Tissues from these deer were positive for PrPSc by IHC and WB. Similar to IC inoculated deer, samples from these deer exhibited two different molecular profiles: samples from obex resembled CWD whereas those from cerebrum were similar to the original scrapie inoculum. On further examination by WB using a panel of antibodies, the tissues from deer with scrapie exhibit properties differing from tissues either from sheep with scrapie or WTD with CWD. Samples from WTD with CWD or sheep with scrapie are strongly immunoreactive when probed with mAb P4, however, samples from WTD with scrapie are only weakly immunoreactive. In contrast, when probed with mAb’s 6H4 or SAF 84, samples from sheep with scrapie and WTD with CWD are weakly immunoreactive and samples from WTD with scrapie are strongly positive. This work demonstrates that WTD are highly susceptible to sheep scrapie, but on first passage, scrapie in WTD is differentiable from CWD.
 
 
2011
 
*** After a natural route of exposure, 100% of white-tailed deer were susceptible to scrapie.
 

TUESDAY, MARCH 28, 2017 

*** Passage of scrapie to deer results in a new phenotype upon return passage to sheep ***



CWD TO CATTLE

***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...


price of prion poker goes up for cwd to cattle;

Monday, April 04, 2016

*** Limited amplification of chronic wasting disease prions in the peripheral tissues of intracerebrally inoculated cattle ***


MONDAY, NOVEMBER 06, 2017 

Experimental transfusion of variant CJD-infected blood reveals previously uncharacterised prion disorder in mice and macaque

''On secondary and tertiary transmissions, however, the proportion of PrPres positive animals gradually increased to almost 100%. 

''Recent communications suggest that a similar situation might exist in other models of experimental exposure to prions involving swine32 and cattle33.'' 

''Experimental transfusion of variant CJD-infected blood reveals previously uncharacterised prion disorder in mice and macaque''



MONDAY, OCTOBER 02, 2017 

Creutzfeldt Jakob Disease United States of America USA and United Kingdom UK Increasing and Zoonotic Pontential From Different Species



THURSDAY, AUGUST 17, 2017 

*** Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease in the United States revisited 2017 Singeltary et al



WEDNESDAY, NOVEMBER 1, 2017 

Blood-derived amyloid-β protein induces Alzheimer’s disease pathologies



Diagnosis and Reporting of Creutzfeldt-Jakob Disease 

Singeltary, Sr et al. JAMA.2001; 285: 733-734. Vol. 285 No. 6, February 14, 2001 JAMA Diagnosis and Reporting of Creutzfeldt-Jakob Disease 

To the Editor: 

In their Research Letter, Dr Gibbons and colleagues1 reported that the annual US death rate due to Creutzfeldt-Jakob disease (CJD) has been stable since 1985. These estimates, however, are based only on reported cases, and do not include misdiagnosed or preclinical cases. It seems to me that misdiagnosis alone would drastically change these figures. An unknown number of persons with a diagnosis of Alzheimer disease in fact may have CJD, although only a small number of these patients receive the postmortem examination necessary to make this diagnosis. Furthermore, only a few states have made CJD reportable. Human and animal transmissible spongiform encephalopathies should be reportable nationwide and internationally. 

Terry S. Singeltary, Sr Bacliff, Tex 

1. Gibbons RV, Holman RC, Belay ED, Schonberger LB. Creutzfeldt-Jakob disease in the United States: 1979-1998. JAMA. 2000;284:2322-2323. 



Terry S. Singeltary Sr.

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