Tuesday, August 8, 2017

Concurrence With OIE Risk Designations for Bovine Spongiform Encephalopathy [Docket No. APHIS-2016-0092]

Subject: Concurrence With OIE Risk Designations for Bovine Spongiform Encephalopathy [Docket No. APHIS-2016-0092]

[Federal Register Volume 82, Number 151 (Tuesday, August 8, 2017)] [Notices] [Pages 37041-37042] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2017-16674] 

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2016-0092] 

Concurrence With OIE Risk Designations for Bovine Spongiform Encephalopathy

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public of our decision to concur with the World Organization for Animal Health's (OIE) bovine spongiform encephalopathy (BSE) risk designations for seven regions. The OIE recognizes these regions as being of negligible risk for BSE. We are taking this action based on our review of information supporting the OIE's risk designations for these regions.

FOR FURTHER INFORMATION CONTACT: Dr. Roberta Morales, Senior Staff Veterinarian, Regionalization Evaluation Services, National Import Export Services, VS, APHIS, 920 Main Campus Drive, Suite 200, Raleigh, NC 27606; (919) 855-7735.

SUPPLEMENTARY INFORMATION: The regulations in 9 CFR part 92 subpart B, ``Importation of Animals and Animal Products; Procedures for Requesting BSE Risk Status Classification With Regard to Bovines'' (referred to below as the regulations), set forth the process by which the Animal and Plant Health Inspection Service (APHIS) classifies regions for bovine spongiform encephalopathy (BSE) risk. Section 92.5 of the regulations provides that all countries of the world are considered by APHIS to be in one of three BSE risk categories: 

Negligible risk, controlled risk, or undetermined risk. 

These risk categories are defined in Sec. 92.1. 

Any region that is not classified by APHIS as presenting either negligible risk or controlled risk for BSE is considered to present an undetermined risk. 

The list of those regions classified by APHIS as having either negligible risk or controlled risk can be accessed on the APHIS Web site at 


The list can also be obtained by writing to APHIS at National Import Export Services, 4700 River Road, Unit 38, Riverdale, MD 20737. Under the regulations, APHIS may classify a region for BSE in one of two ways. One way is for countries that have

[[Page 37042]]

not received a risk classification from the World Organization for Animal Health (OIE) to request classification by APHIS. The other way is for APHIS to concur with the classification given to a country by the OIE. If the OIE has recognized a country as either BSE negligible risk or BSE controlled risk, APHIS will seek information to support our concurrence with the OIE classification. This information may be publicly available information, or APHIS may request that countries supply the same information given to the OIE. APHIS will announce in the Federal Register, subject to public comment, its intent to concur with an OIE classification. In accordance with that process, we published a notice \1\ in the Federal Register on January 23, 2017 (82 FR 7786, Docket No. APHIS- 2016-0092), in which we announced our intent to concur with the OIE risk designations for seven regions. The OIE recognizes these regions as being of negligible risk for BSE. We solicited comments on the notice for 60 days ending on March 24, 2017. We received one comment by that date, from a private citizen. 

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 \1\ To view the notice and the comment we received, go to 


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 The commenter expressed concern that there is no process for verifying whether ruminant-to-ruminant feed bans are effectively enforced. As part of its risk assessment process, the OIE considers the likelihood that the BSE agent either could be introduced into or spread within a country through contaminated commodities, including animal feed and feed ingredients. They consider both the production of processed animal proteins from domestic livestock, and the use of imported processed animal proteins, animal feed, and feed ingredients when assessing that risk. APHIS reviews similar information before concurring with the OIE designation. Once recognized as either negligible or controlled risk for BSE by the OIE, a country must submit data on surveillance results and feed controls for the previous 12 months annually to maintain that status. If a country fails to provide that data in a timely manner, or the data shows changes that increase the risk of BSE introduction or spread, the country's risk designation may be changed. In the event that a country's risk status is demoted by the OIE, APHIS would also change its risk designation for the country. Within the United States, the Food and Drug Administration (FDA) is the Federal agency responsible for regulating animal feed. The FDA has established regulations in 21 CFR part 589 that prohibit mammalian protein in ruminant feed (which includes a ruminant-to-ruminant feed ban) and the use of tissues that have the highest risk for carrying the BSE agent in all animal feed. These high risk cattle materials, known as specified risk materials (SRM), include the brains and spinal cords from cattle 30 months of age and older. To assess and monitor for compliance with the feed ban, the FDA established the ruminant feed ban inspection program and guidance to assist both the FDA and State investigators. Feed mill and rendering plant inspections conducted since 1998 indicate a very high level of compliance with the feed ban. Summaries of inspections can be viewed on the FDA Web site at


The FDA also established a feed testing program in 2001. The FDA's highest priority for sample selection is given to finished products intended for ruminants, and feed ingredients that may reasonably be expected to be later used in ruminant feed. The commenter also expressed concern that products from cattle slaughtered at 36 months of age pose a health risk to consumers. The commenter is correct that certain bovine products and live cattle from specific countries with a higher risk of BSE release may carry BSE infectivity and therefore present a health risk to consumers if no measures are taken to mitigate that risk. For this reason, the OIE also describes specific requirements for certain commodities originating from regions of controlled and undetermined risk. APHIS regulations require implementation of and compliance with very similar requirements for both live bovines and bovine commodities in a region before we concur with the OIE's BSE risk designation. These requirements mitigate the risk of exposure to a negligible level. Therefore, countries with either controlled or undetermined risk statuses must demonstrate that they have the authority to conduct oversight of the compliance with such requirements. 

Therefore, in accordance with the regulations in Sec. 92.5, we are announcing our decision to concur with the OIE risk classifications of the following countries: Regions of negligible risk for BSE: Costa Rica, Germany, Lithuania, Mexico, Namibia, Romania, and Spain.

 Authority: 7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.

 Done in Washington, DC, this 2nd day of August 2017. Michael C. Gregoire, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2017-16674 Filed 8-7-17; 8:45 am] BILLING CODE 3410-34-P 



''To assess and monitor for compliance with the feed ban, the FDA established the ruminant feed ban inspection program and guidance to assist both the FDA and State investigators. Feed mill and rendering plant inspections conducted since 1998 indicate a very high level of compliance with the feed ban.''



Therefore, in accordance with the regulations in § 92.5, we are announcing our decision to concur with the OIE risk classifications of the following countries:

Regions of negligible risk for BSE: Costa Rica, Germany, Lithuania, Mexico, Namibia, Romania, and Spain. 

Authority: 

7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.

Done in Washington, DC, this 2nd day of August 2017.


LET'S LOOK AT SOME HISTORY OF 3 OF THE 7 NEW COUNTRIES RECOGNIZED BY APHIS/USDA/OIE ET AL...


Spain BSE


MONDAY, JUNE 19, 2017 

PRION 2017 CONFERENCE ABSTRACT 

P61 vCJD strain properties in a Spanish mother and son replicate as those of a young UK case 

P61 vCJD strain properties in a Spanish mother and son replicate as those of a young UK case 

Dr Abigail Diack1, Mrs Aileen Boyle, Dr Diane Ritchie2, Jesus de Pedro-Cuesta3, Alberto Rabano4, Prof Robert WiLL2, Prof Jean Manson1 1The Roslin Institute, Easter Bush, United Kingdom, 2National CJD Research & Surveillance Centre, Edinburgh, United Kingdom, 3National Center of Epidemiology and CIBERNED, Madrid, Spain, 4CIEN Tissue Bank, ClEN Foundation, and ClBERNED, Madrid, Spain 

Aims Since the first report in 1996, there have been 228 cases of vCJD worldwide. Comparative studies of vCJD cases have demonstrated similar clinical symptoms, patterns of neuropathology and biochemical phenotype between cases originating from different countries. Here we have investigated transmission characteristics of the first cases of vCJD in first-degree relatives, a mother and son who resided in Spain. Both individuals are in the older age range of reported vCJD cases and had relatively atypical early clinical symptoms when compared to UK cases. 

Methods A strain typing panel of wild-type mice was inoculated with brain homogenate prepared from both the Spanish mother (aged 64) and son (aged 41) and compared with a UK case of vCJD. Mice were assessed for clinical signs, neuropathology and PrPres glycoform profile. 

Results All three vCJD brain isolates transmitted successfully to the wild-type mouse panel with the appearance of clinical and pathological signs associated with TSE transmission to mice. Inocula from the Spanish mother and son showed the same temporal order of clinical endpoint in each mouse strain when compared with the UK case. The distribution of TSE vacuolation was consistent for each vCJD inocula however variability in the intensity of vacuolation distribution was apparent. This was most evident in the VM mice challenged with the Spanish mother and may be indicative of low titre. PrP deposition patterns were similar between inocula with variability in the intensity of PrP accumulation between mice observed both within and between groups. PrPres was detected in the brains of RIII and VM mice challenged with all three isolates with no differences detected. 

Conclusions This study of two first degree relatives with vCJD confirms that the same infectious TSE agent was responsible for both cases and is consistent with that of a UK case of vCJD and historical vCJD transmission data. This is the first strain characterisation study of an older individual with vCJD and highlights the need for awareness of vCJD in older age groups particularly in those presenting with atypical dementias. These findings add additional supporting evidence to the hypothesis that a single strain of TSE agent is responsible for vCJD cases regardless of geographical origin or age at infection and indirectly support the hypothesis of a dietary origin for primary cases of vCJD. 

PRION 2017 DECIPHERING NEURODEGENERATIVE DISORDERS 


FRIDAY, MARCH 10, 2017

OIE Spain Prion (Atypical BSE type L) Bovine Spongiform Encephalopathy Mad Cow Disease


FRIDAY, JUNE 3, 2016 

The epidemiological evolution of prion infection on bovine in Romania, in the period of 2010 – 2015 

PRION 2016 TOKYO JAPAN


ROMANIA BSE

THURSDAY, DECEMBER 25, 2014 

Bovine spongiform encephalopathy, Romania Confirmed


MEXICO BSE

EFSA concludes that the current geographical BSE risk (GBR) level is III, i.e. it is likely but not confirmed that domestic cattle are (clinically or pre-clinically) infected with the BSE agent. The GBR is likely to increase due to continued internal and external challenge, coupled with a very unstable system. 


MEXICO BSE GBR

Scientific Report of the European Food Safety Authority on the Assessment of the Geographical BSE-Risk (GBR) of MEXICO

Question N° EFSA-Q-2003-083

Adopted July 2004

Summary

The European Food Safety Authority and its Scientific Expert Working Group on the Assessment of the Geographical Bovine Spongiform Encephalopathy (BSE) Risk (GBR) were asked by the European Commission (EC) to provide an up-to-date scientific report on the GBR in Mexico, i.e. the likelihood of the presence of one or more cattle being infected with BSE, pre-clinically as well as clinically, in Mexico. This scientific report addresses the GBR of Mexico as assessed in 2004 based on data covering the period 1980-2003.

The BSE agent was probably imported into Mexico and could have reached domestic cattle. These cattle imported could have been rendered and therefore led to an internal challenge in the mid to late 1990’s. It is possible that imported meat and bone meal (MBM) into Mexico reached domestic cattle and leads to an internal challenge around 1993.

It is likely that BSE infectivity entered processing at the time of imported ‘at - risk’ MBM (1993) and at the time of slaughter of imported live ‘at - risk’ cattle (mid to late 1990s). The high level of external challenge is maintained throughout the reference period, and the system has not been made stable. Thus it is likely that BSE infectivity was recycled and propagated from approximately 1993. The risk has since grown consistently due to a maintained internal and external challenge and lack of a stable system.

EFSA concludes that the current geographical BSE risk (GBR) level is III, i.e. it is likely but not confirmed that domestic cattle are (clinically or pre-clinically) infected with the BSEagent. The GBR is likely to increase due to continued internal and external challenge, coupled with a very unstable system.

http://www.efsa.europa.eu/en/efsajournal/doc/4r.pdf

Key words: BSE, geographical risk assessment, GBR, Mexico, third countries

SNIP...

Annex to the EFSA Scientific Report (2004) 4, 1-13 on the Assessment of the Geographical BSE Risk of Mexico

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2.3 Overall assessment of the external challenge

The level of the external challenge that has to be met by the BSE/cattle system is estimated according to the guidance given by the SSC in its final opinion on the GBR of July 2000 (as updated in January 2002).

Live cattle imports:

According to the CD the country imported in total over the period 1980 to 2003, approximately 3.2 million live cattle from BSE - risk countries, of which conclusively none came from the UK. The numbers shown in table 1 are the raw import figures and are not reflecting the adjusted imports for the assessment of the external challenge. Broken down to 5 - years periods the resulting external challenge is as given in table 3. This assessment takes into account the evidence that certain imported cattle did not enter the domestic BSE/cattle system, i.e. were not rendered into feed. In the case of Mexico, it is assumed that “cattle still alive” (imports from Spain) did not enter the rendering system.

MBM imports:

According to the CD the country imported in total over the period 1980 - 2003 approximately 826,000 tons MBM from BSE - risk countries (according to “other data”: ~ 919,000 tons), of which none came from the UK. The numbers shown in table 2 are the raw import figures and are not reflecting the adjusted imports for the assessment of the external challenge. Broken down to 5 - years periods the resulting external challenge is as given in table 3. This assessment takes into account the evidence that certain imported MBM did not enter the domestic BSE/cattle system or did not represent an external challenge for other reasons. However, in the case of Mexico, there was not sufficient evidence to remove any quantities of MBM from the external challenge.

SNIP...

Annex to the EFSA Scientific Report (2004) 4, 1-13 on the Assessment of the Geographical BSE Risk of Mexico

- 12 -

would harbour, while being pre - clinical, as much infectivity as a clinical BSE case. Hence cattle imports could have led to an internal challenge about 3 years after the import of breeding cattle (that are normally imported at 20 - 24 months of age) that could have been infected prior to import. In case of Mexico this implies that an internal challenge caused by live cattle imports (predominantly from USA or Canada) first occurred in the mid to late 1990’s and continued to the present.

On the other hand imports of contaminated MBM would lead to an internal challenge in the year of import, if fed to cattle. The feeding system is of utmost importance in this context. If it could be excluded that imported, potentially contaminated feed stuffs reached cattle, such imports might not lead to an internal challenge at all. In case of Mexico this implies that an internal challenge caused by MBM imports (predominantly from USA or Canada) first occurred around 1993 and continued to the present.

In view of the above - described consideration the combination of the very / extremely high external challenges with a very unstable system makes the occurrence of an internal challenge likely in Mexico from approximately 1993 onwards.

4.2 Risk that BSE infectivity entered processing

It is likely that BSE infectivity entered processing at the time of imported ‘at - risk’ MBM (1993) and at the time of slaughter of imported live ‘at - risk’ cattle (mid to late 1990’s). The high level of external challenge is maintained throughout the reference period, and the system has not been made stable, leading to increased internal challenge.

4.3 Risk that BSE infectivity was recycled and propagated

It is likely that BSE infectivity was recycled and propagated from approximately 1993. The risk has since grown consistently due to a maintained internal and external challenge and lack of a stable system.

5. CONCLUSION ON THE GEOGRAPHICAL BSE – RISK

5.1 The current GBR as function of the past stability and challenge

The current geographical BSE risk (GBR) level is III, i.e. it is likely but not confirmed that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent.

5.2 The expected development of the GBR as a function of the past and present stability and challenge

***• The GBR is likely to increase due to continued internal and external challenge, coupled with a very unstable system.

SNIP...

http://www.efsa.europa.eu/en/efsajournal/doc/4r.pdf


***The most recent assessments (and reassessments) were published in June 2005 (Table I; 18), and included the categorisation of Canada, the USA, and Mexico as GBR III. Although only Canada and the USA have reported cases, the historically open system of trade in North America suggests that it is likely that BSE is present also in Mexico.

http://www.oie.int/boutique/extrait/06heim937950.pdf

Subject: Mexico SAGARPA Assessment of BSE VS EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of Mexico

Date: February 5, 2007 at 1:11 pm PST

Empresa solicitante: SAGARPA

Tipo del análisis efectuado: Cuantitativo

Temática: “Análisis de riesgo sobre la ocurrencia de la encefalopatía espongiforme bovina en México”

INTRODUCTION:

The bovine spongiform encephalopathy (BSE), it is a neurological disease, invariably fatal and with long period of incubation, that affects cattle. Its etiologic agent is the prion. General consensus exists with respect to that the feeding of contaminated meat and bone flours, it is the most significant source in the dissemination and transmission of this etiologic agent. At this time there is no exist evidence that BSE is transmitted by means of embryos, their semen and in case of existing maternal transmission, if this could happened it would be in a so extremely low rate that it could not be considered like a trigger or leading factor of an epidemic. Controversy in respect to other probable ways of transmission remains. The BSE was diagnosed for the first time in 1986 in the United Kingdom. At this time it exists in 26 countries, including a Canada and the United States of North America (USA).

This document summarizes the analyzed elements and the results of the study of the evaluation of the risk factors, of the epidemiology surveillance and related activities, as well as the quantitative estimation of the risk with respect to the probability of introduction of the disease to the Mexican herd.

EVALUATED ELEMENTS:

Demography and characteristics of the Mexican cattle industry: Cattle is one of the main activities in the Mexican farming sector, due to its contribution in the supply of meat (beef) products, dairy, among others; as well as its participation in the international trade on cattle exports, mainly to the United States of North America.

According to data of the 2001, cattle population is of 30.620.933 of heads, of which 28.480.803 are beef cattle and 2.140.130 dairy cattle. The main cattle production states are located in the center-north, where its operation is intensive and its feeding is based on grains; as well as in the coast of the Gulf of Mexico and the south-southeastern, with intensive programs and feeding is based mainly on the pasturing (grass). The national dairy herd, is calculated as specialized or technified that represent 17,44% of the herd, semi-specialized 14,90% of the herd, double-purpose herd (beef and dairy) 59,68% and the small family-run herd or the referred as “backyard” (traspatio) 7,98%.Previous numbers are to be considered as an estimation of the dairy livestock inventory by production units. Nevertheless, it is necessary to consider that all races of pure breed can be found in anyone of those groups.

Legal grounds: Mexico counts on a normative frame that covers (deals with) the relevant aspects of the Epidemiology Surveillance of the BSE, like the Federal Law of Animal Health, the Federal Law of Metrology and Regulation, the General Law of Health and several Mexican Official Norms (NOM-009-Z00-1994, Sanitary process of the meat, NOM-030-ZOO-1995, Specifications and procedures for the import of beef, carcasses, viscera and offal at zoo-sanitary inspection points, NOM-061-ZOO-1999, Zoo-sanitary specifications of nutritional products destined for animal feed and NOM-060-ZOO-1999, Zoo-sanitary specifications for the transformation of animals offal and its use in animal feeding). Wider and extended covertures of these regulations were evaluated.

Veterinary infrastructure: The veterinary services in the country are structural and normative organized by the Mexican State through the Secretariat of Agriculture, Livestock, Rural Affairs, Fishery and Alimentary (SAGARPA) Federally Empower, that is to say, that has the capacity and authority to negotiate an to come to agreement with the States Governments that integrate the Republic; to coordinate itself with the other Secretariats of State; to deal with organizations of the Private and Social sector as well as with the rest of the Civil Society as a whole.

The National Service of Health, Food Safety and Ag-alimentary Quality (SENASICA), it is an organism of this Secretariat, which has attributions in the matter of vegetable health, animal health and ag-alimentary safety and is conformed by the following main directorates: Sanidad Vegetal, Salud Animal, Inocuidad Agroalimentaria, Acuícola y Pesquera, Inspección Fitozoosanitaria, (equivalent to U.S. APHIS, FSIS and VS –Veterinary Services) Jurídica, Administración e Informática. In accordance with the assigned attributions, it corresponds to central offices the substantive part and the operative part, to the personnel assigned to the State Delegations of the SAGARPA and other instances of the SENASICA.

Consequently, the four main areas are assigned to the Main directorate of Salud Animal-Animal Health (DGSA) and to the Main directorate of Inspección Fotozoosanitaria-Plant Inspection (DGIF) and Veterinary Services (SV) in Mexico are in charge of: surveillance, epidemiology, animal movement, zoo-sanitary campaigns and emergencies.

Imports This is perhaps one of the medullar points, in the sense that it represents the information of the imports made during the risk periods and therefore, it provides the fundamental information for the risk assessment. In 1991, Mexico implemented measures to avoid the appearance of BSE, as the disease had become a serious worldwide problem, reason why, live bovines imports were prohibited, beef, beef products and by-products and in 1994 flour of meat and bone from countries affected by this disease was also prohibited and in the 2000 MBM feeding ban was imposed. In order to mitigate the risk of transmission of the EEB, a revision of the established requirements for import for ruminants’ products began.

Cattle imports and its products and by-products, as well as specific risk materials played a very important role in this study, where considerable amounts of cattle imports from countries now affected by BSE were identified, countries that at the time of the import they remained clean and therefore just some preventive risk measures were in place.

Slaughter, Cattle disposition and Offal.- Different cattle slaughter schemes were analyzed as well as the processes in use, finding some significant differences among them, being the most important the sanitary jurisdiction of the organizations that regulate us.

In Mexico, the slaughter is divided in three different systems, Federal Inspection Type Plants (TIF), which has been increased in the past years; in 1992 they participated with the 13,5%, in 1997 with the 19,40% and in 2002 with the 26,60% of the national total. In the case of the municipal slaughterhouses from 1992 to 1997, their slaughtered animals corresponded to the 49,5% and for 2002 it was increased to 73,4%, whereas the slaughter in private plants decreased of 37,10% in 1992 to 31,10%, in 1997 and from 1998 to date, we have no information.

The procedures to be followed by the establishments in the animal slaughter and those that industrialize, process, packing, chilled/froze beef products or by-products for human consumption, in order to obtain products of optimal hygienic quality, are written in the NOM-009-ZOO-1994 “sanitary Process of Beef”.

The direct consumption of beef can be stratified in three great destinies, differentiated by the market that are destined to, the rural one, the one of small centers of population, (and) the one of the big cities, characterized each one of them by its consumption and the partial or integral industrialization by direct consumer and by means of commercialization or points of sale, as well as for the origin of the own supplier.(?)

Rendering of Cattle Products.

The processes applied by the rendering plants for obtaining the protein from inedible offal, were evaluated.

Food elaboration and its use for animal feeding.- This analysis was focused in the processes of food elaboration for animal consumption.

In Mexico, the control in the production of food from animal origin, as much as the elaboration of the meat flour as that of the balanced food manufacture it is regulated by the Mexican Official Norm NOM-061-ZOO-1999, “Zoo-sanitary Specifications of nutritional products for animal consumption”, which bans the use of MBM flours of ruminant origin or any mixture that contains it for the elaboration of balanced meals for ruminants, and the Mexican Official Norm NOM-060-ZOO-1999, “Zoo-sanitary Specifications for the transformation of animal offal and its use in the animal feeding”.

In accordance with the Section of Manufacturers of Balanced Food for Animals of the National Camera of the Industry of Transformation (CANACINTRA), there are 396 balanced food plants registered, same that have the capacity to produce more than 20 million tons a year, according to the numbers registered during 1999-2002. 63% of such plants are integrated and produce 64% of the animal feed produced nationwide, the rest corresponds to commercial plants.

The animal feed produced by the integrated plants, that is the most significant part, during the 2002 it produced the 58,7% of the products destined for raising of poultry, the 16,5% for swine, the 14,3% for dairy and 9,2% for feedlots (cattle) and 1,3% for other species.

As far as the composition of the main raw materials to produce balanced foods, these mainly correspond in 45% to domestic sorghum and 55% sorghum concentrated; 16% to domestic yellow maize and 84% imported; 91% domestic protein pastes and 9% imported; 80% of other domestic forage grains (broken maize, wheat, barley, oats, etc.) and 20% imported and other ingredients (wheat by-products, maize, vitamins, minerals, oils, etc.).

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Neuropathies in Mexico, Epidemiology Surveillance Program.- For this analysis, the legal elements related to the notification of the BSE were taken into account, in Mexico, as well as the activities made by the Commission Mexico - United States for the Prevention of the Aftosa Fever and Other Exotic Diseases of Animals (CPA), official entity in charge of carrying out this activity and other connected activities as training, taking of samples and the diagnosis of laboratory.

BSE Diagnosis.

Veterinary Services diagnoses capacity was evaluated as well as its adherence to the international standards, according to what is indicated by the International Organization of Animal Health (OIE), as well as the processes of taking and shipping of samples.

For the diagnosis of the BSE, the OIE recommends five laboratory tests: Histopathology (HP), Immunohistochemistry (IHQ), Western blot (immunotransferency), ELISA (enzimoinmunoassay) and Bio-assay in mouse. At this time Mexico counts with two laboratories of diagnosis for this disease: the National Center of Services of Diagnosis in Animal Health (CENASA) and the Laboratory of high security of the CPA. The CENASA performs the histopathology test and at the CPA the Immunohistochemistry test is carried out.

The reception of samples at CPA, it depends to a great extent on the economic resources which are accounted for this activity, expense that is approximately of $400,00 ($ 36.50 USD.) per sample received (includes the material for conservation, packing and shipping), reason for what, have to wait for the collection of several to be sent at the same time and in order to reduce costs, but delaying the result. As the CPA does not have a certified pathologist to carry-out the HP test technique, these samples are sent to the CENASA for their diagnosis; this implies that such samples are stored by approximately one week, since it doesn’t have the human resources for its transfer.

The main problem at CENASA, for the right operation of the diagnosis of the BSE, it is the lack of coordination on shipping and receiving of samples, which is not done accordingly to the calendar of the laboratory and the operative area, because in a short period of time the expected/projected number of samples is exceeded, resulting in delays in accomplishment of the tests and the disposition in excess of material and human resources.

At this moment, the techniques are being standardized, Immunohistochemistry at the CENASA and the western blot (immunmotransferency) at the CPA, which will allow us to have more tools for the diagnose in Mexico; in addition, the WB allow us to count on another technique of the higher sensitivity and specificity, that guarantees optimal result in less time (approximately 8 hours).

It must be mentioned that, we have had contemplated the formation of a network of laboratories of diagnosis of TSE´s to specialized on the HP technique, where we will have 6 regional laboratories and 4 universities involved, this will in the future allow the processing and diagnosis of the sample from its place of origin and only its confirmation by other techniques at central level. For this, we already count with the procedure for the authorization and verification of a laboratory of histopathology for the diagnosis of the BSE.

Monetary Compensation to cattle dealers: Because the BSE is considered as an exotic disease, a contingency fund that could be put to work in case the disease appears, does not exist at this time.

In the case of the contingency funds, the national campaign for diseases relies on a section on this subject. Nevertheless, for the exotic diseases official norms do not exist and article 36 of the Federal Law of Animal Health only establishes that will be due to create, but it does not explain the mechanism to be considered for its creation.

The pre-established form to compensate the possible producers that are themselves affected by the presence of BSE in their cattle, it will be from the federal budget that is agreed upon the program Alliance for the Country for the corresponding fiscal year.

In this sense, it is necessary to pinpoint that the minimum amount to consider for this budget will be a 4% of the total assigned to the Fito-zoo-sanitary Contingencies Plan on behalf of the Federal Government.

This will have a distribution by federal entity, which a specific amount will be able to be assigned to joint, if necessary, to the DINESA against the BSE. Also, the State Governments will proportionally contribute an equal amount to the federal to be incorporated to the compensation funds of the Device of Emergency. As for the cattlemen, they will have to come-up with resources equivalent to the third part of the total amount assigned by the Federal and State governments.

Animal identification and traceability of cattle products.- Different elements were considered with which Mexico counts on to carry out the traceability of animals and its products upon a sanitary problem, including the animal identification and the organizations related to this activity.

 Actually, the identification system of the cattle in Mexico is organized in two forms, one State-ID with aims of demonstration of property and control of cattle rustling and another Federal-ID, with aims of identification for the development of the zoo-sanitary campaigns against the bovine tuberculosis and brucellosis, first it is based on the registry and recognition of the Hot-Brands of each producer, and the second in addition to the previous system, one is based on a metallic earring of blue color with a number of identification, which is described in the NOM-031-ZOO-1995, Campaña Nacional Contra la Tuberculosis Bovina (Mycobacterium bovis), National Campaign Against Bovine Tuberculosis.

This procedure assigns a number to an animal, which is used during zoo-sanitary surveillance campaigns, these activities are registered along with an identification number, in a document called test-opinion, in which it is written down, in addition to the test results applied to the animals, the identification and data of the cattle herd and ranch of origin of the animal for its later traceability. This test-opinion is along with the certificate of “Herd free of bovine tuberculosis” as described in the same Mexican Official Norm.

According to the procedure previously described, in Mexico, there were around 3.291 registered herds with 282.932 heads of bovines identified in 2003, that represents 0,94% of the total population in this country.

Nevertheless, in the same NOM, it’s expressed in point 11 referring to mobilization that the animals coming from disease-free herds, they will be able to be mobilized to any destination within the national territory with no need to be tested for tuberculosis before its mobilization, if the following requirements are met: obtain a zoo-sanitary certificate, and for the zoo-sanitary certificate to be issued, certification that they come from a disease-free herd and that the animals must have a disease-free herd identification.

Considering that in order to mobilize the animals it is necessary to have a valid disease-free zoo-sanitary certificate, we can estimate that there are more than 3,431,022 identified animals, according to the information obtained from the Statistical Report of the Cattle Mobilization of FY2000, with information captured up to the 24 of August of 2001 by the National Organism of Herd Certification, A.C., that represents the 11,4% of the bovine total population on which we can observe that more than 50% of these mobilizations are directed to slaughterhouses, 17% to feedlots, 15% for export and 11% for pasturing.

Based on the above, experience of a suitable animal traceability is shown specially in the case of the animals destined to be exported, where the USDA when finding a positive animal reactor to the tests of tuberculosis in the United States, it has been possible to trace it back to its the original herd; on the other hand, the identification system used on dairy cattle, which counts on a homogenous system of identification for production and genetic improvement control, nevertheless, this mechanism although is available for the federal government, it would make use of, only in the presence of a serious epidemiology event.

Educational Programs, Awareness and Training.- The CPA, one of its activities, is to maintain a permanent program of training courses on exotic diseases of the animals, on a national context. In 1994, BSE awareness programs were incorporated , with the diffusion of information, talks and courses on the following areas: disease history, economic consequences, etiology, transmission mechanisms, clinical signage, histopathology injuries, differential diagnosis, measures of prevention and activities of epidemiologist surveillance, supported by audio-visual means, these programs are taken to a diverse audience, including the students of the last semesters of Veterinary Medicine, to the personnel that conforms the Quarantine National System, as well as Veterinary Doctors, government, private and to other specialists.

ESTIMATION OF RISK (Risk Assessment)

According to the qualitative estimation in this assessment, it was determined that the risk of occurrence of the disease in the bovine population, is low.

The quantitative estimation index was located at 5.268908E 08 of the risk of disease exposure of the national herd, number that represents numerically like a low probability of occurrence of the problem in Mexico.

CONCLUSIONS AND RECOMMENDATIONS

Conclusions

The BSE is a disease that was described for the first time in 1986, nevertheless, today, epidemiologists have many unanswered questions on how is transmitted.

The introduction of the BSE in Mexico would cause a serious socioeconomic impact, commercial, political and probably of public health concern, because the presence of the disease would restrict sanitarily and commercially, disrupting the actual distribution of meat products at national level and to other countries, independently of the impact in the consumption of the inhabitants with respect to the beef consumption and products of bovine origin.

Considering the way of transmission, in case of a breakout, the native animals that are at greater risk of being infected in Mexico, those are the dairy cattle in specialized systems and the bovines at feedlots in the arid and tropical regions.

In Mexico, we got Laws, Mexican Official Norms and Agreements, that cover relevant aspects of the epidemiology surveillance of the BSE, same that must be fortified in its operative phase, mainly in its application and enforcement.

The Mexican Official Norm NOM-030-ZOO-1995, Specifications and procedures for the import of beef, carcasses, viscera and offal at zoo-sanitary inspection points, prohibits the import of cattle products, however, fresh beef has been imported, chilled, frozen and beef preparations, as long as it comes from animals smaller of thirty months of age, which diminishes the risk but does not exclude it.

The evaluation showed that the four great areas of concern are assigned to the Main Directorate of Animal Health (DGSA) and to the Main Directorate of Fito-zoo-sanitary Inspection (DGIF); responsibility of the Veterinary Services in Mexico, in relation to the BSE are: epidemiology surveillance, animal movement control, zoo-sanitary campaigns and emergencies; functionality and capability of communicating among them was evaluated as we as the capacity of response before a sanitary emergency caused by the BSE.

***It is necessary to increase and to better coordination of the surveillance activities, particularity between the areas of diagnoses and operational, for the correct execution of the surveillance activities in the field.

***The imported bovines (1996-2003) have been slaughtered and those destined to improve genetics, once they conclude their productive life and are discarded, will also be slaughtered.

***The actions of detection of downer-cows need to be reinforced for its processing at TIF plants, till now a deficient activity, where the majority of the animals with such clinical characteristics, regularly are not taken this plants but rather are slaughtered at same ranch/location and consumed regionally or they are taken to slaughterhouses without supervision and sanitary inspection.

***Ante mortem inspections need to be reinforced at Federal Inspection Type Plants, municipal and private slaughterhouses, mainly in these two last ones, with the purpose of detecting bovines clinically affected by BSE.

***There is commercial interest to incorporate flours of meat and bone of ruminants in the rations destined to the feeding of the bovines, like an alternative source of protein matter, reason why official mechanisms must be reinforced in preventing this type of illegal practices.

***One of the tools in preventing the BSE is to avoid the exposure of the native bovines to the consumption of presumably contaminated feed with the pathological agent or unless is processed by means of a thermal process that guarantees its inactivation. However, the heat treatment that the flours of meat and bone are put under in XXXXXX XXXXX XXXXX XXXXXX XXXXXX XXXXXX XXXXXX XXXXX XXXXX XXXX XXXXX XXXXXX XXXXX XXXXX XXXXXX XXXXX XXXXX XXXX during 20 minutes), even though this one, it does not guarantee the destruction of the prion either, but it reduces its infectivity significantly.

***The Country counts on regulations, in respect to the transformation of offal (NOM-061-ZOO-1999), there still are deficiencies as to the number and qualification of the personnel responsible in supervising their fulfillment through inspection and verification.

***Deficiencies in the availability of technical information at official and private levels were detected, crucial information necessary for the elaboration of the present assessment, such as the case of the information on product imports and on rendering plants, were not available for the study.

***Blood was not considered as a potential source of transmission of the BSE, by-product in form of flour (dry blood), that is also produced by the rendering plants and is used in animals feeds.

***The BSE epidemiology surveillance program in Mexico must be reinforced by focusing on a target animal study (bovine suspected of BSE and with suggestive clinical signs of the disease). On the other hand, as a result from this study, we found that a percentage of the obtained samples for BSE testing have been inadequately collected and among other causes were: absence of cerebral stem, incomplete cerebral stem, over-manipulated samples, advanced changes (decompose) postmortem, not enough tissue to work on, low concentration of conservative (solution) or samples taken from inadequate age of animal (too young); showing all of these, a necessity to review these procedures.

***It was also detected the fact that, as a routine practice the samples sent for the diagnosis of bovine rabies, whenever they come out positive to this disease, they are no longer processed for the BSE testing, discarding with this, the possibility of finding both diseases in a same animal, rabies virus and the BSE prion. It is also concluded that with the loss of diagnosis material, it prevented us from obtaining valuable epidemiology information useful in restructuring our surveillance program.

***The identification of the cattle, as well as the traceability of its products and by-products, presents serious deficiencies at national level, which is important in case the BSE is detected in the Country, given its importance like a primordial component to trace, to prevent and to eradicate this and other animal diseases, turning out to be an additional vital tool to determine the dissemination degree in case of break-out in the country, that would immediately allow us to be able to establish its origin (native or imported) and to take the appropriate counter-epidemic measures.

***From 1994, the Commission Mexico - United States for the Prevention of Foot-and-Mouth Disease (FMD) and other Exotic Diseases (CPA), it has carried out activities of awareness and training on BSE, however, this has been centered to certain zones of the country, leaving some other zones, particularly the rural zones without cover, same that can provide with valuable epidemiology information and some cases for diagnosis of neuropathy in ruminants.

*** According to the analysis made on the risk assessment in its qualitative modality, it is considered like low-risk, the risk of introduction of the BSE to the national herd, whereas the quantitative study locates it in values of 5.268908E-08.

Recommendations:

We ought:

to reinforce the inspection and supervision activities by the sanitary authority of the SAGARPA over all of those involved in the cattle production chain, in respect to the fulfillment and application of the established technical regulations expressed on the official norms on the monitoring of BSE, specially the NOM-060-ZOO-1999, Zoo-sanitary specifications for the transformation of animals offal and its use in animal feeding and the NOM-061-ZOO-1999, Zoo-sanitary specifications of nutritional products for animal consumption;

to increase the number of inspectors (Vet Doctors) as much as governmental as private, with a vision of having a better supervision of the rendering plants and feed factories. It is recommendable that such inspectors have a veterinary doctor’s degree.

to reinforce the active epidemiology surveillance subsystem, having special attention to aim at target animals and the size of the statistical test, as well as its stratification at national level;

to review, to update and to homologate the criteria and definitions of the Mexican official norms related to the monitoring of the BSE and the requirements of import, according to norms NOM-008, NOM-030 and NOM-060;

to provide technical and legal elements in the official norms, that may allow to optimize the use of financial and human resources (federal, state and private), with the purpose of that the material and human infrastructure, the installed diagnoses and the potential, can be used with greater efficiency, in the prevention activities, diagnosis and surveillance of the BSE in Mexico;

to homologate the mechanism of training in the obtaining of the samples for the BSE, using the technique of the teaspoon, by means of a national program;

to have a certified pathologist for the high security laboratory of the CPA, because this situation of not having one, causes the delay in the processing of samples, as well as the loss of economic resources by requiring the support of the CENASA;

to plan the taking of samples at a national level and to coordinate its shipment to the CPA for its processing in the laboratory of high security or its re-expedition to the CENASA, with the purpose of optimizing the diagnosis;

to obtain funds and allocate them at each state, in order to compensate cattle dealers affected by the animal culling at risk by BSE, in case of BSE showing up in Mexico, the same or similar mechanism are to established for the handling of monetary compensation, like the one used on the Alliance for the Country or to extend the already existing state government faculties, by means of an exclusive and specific account for the implementation of BSE comp payment.

to implement a national animal identification and traceability system, its products and by-products, that it may allow us to apply prevention measures and control of diseases, as it would be the case of the BSE.

With foundation in Article 14, fraction VI, of the Federal Law of Transparency and Access to the Governmental Public Information, the following paragraphs have been blocked:

Justification of the blockade (p. 6, paragraph 1):

Gallinaza and pollinaza- feather meal (hay bed or substrate on which birds grow up, constituted by rice husk, straw or another type of hay, agriculturist, that at the end of the raising cycle of young hens or chicken, contains the feces of the animals that were bred on it, as well as rest of non-consumed food by the birds), it has been considered in multiple occasions, like an element of potential risk in the transmission of the bovine spongiform encephalopathy (BSE), when it is used to feed ruminants. The risk is generated, as it is common, the bird feed, contains flours of meat and bone of ruminant like source of protein. In this way, in theory, if some of the bovines with which the meat and bone flour was prepared as bird feed were infected with the BSE prion and given the high resistance of the agent (prion) to high temperatures, in the industrial process as the making of the flour, like the making of the nutritional concentrated feed for birds, and even the passage by digestive-tract of the bird, it would not guarantee the destruction of the BSE prion, reason why the possibility would exist, when gallinaza or pollinaza is used in the feeding of ruminants, this could infect susceptible ruminants.

With foundation in Article 14, fraction VI, of the Federal Law of Transparency and Access to the Governmental Public Information, the following paragraphs have been blocked:

Justification of the blockade (p. 6, paragraph 2):

As much gallinaza as pollinaza, they can contain up to a 3% of wasted food, independently of bird feces that could also contain the prion, all implying that the flours of meat and bone of bovine origin, can be consumed by other bovines and by doing this, constituting a possible situation of BSE risk.

***Norma NOM-060-ZOO-1999 Zoo-sanitary specifications for the transformation of animal’s offal and its use in animal feeding and the NOM-061-ZOO-1999 Zoo-sanitary Specifications of nutritional products for animal consumption, they clearly indicate the prohibition to feed ruminants with flours of meat and bone of ruminant origin, however, the prohibition to feed ruminants with gallinaza or pollinaza, is not contemplated in these norms.

With foundation in Article 14, fraction VI, of the Federal Law of Transparency and Access to the Governmental Public Information, the following paragraphs have been blocked:

Justification of the blockade (p. 6, paragraph 3):

***Other elements to consider are the production cycles of the farms of birds in Mexico, a common practice is that when a cycle is reached (ended) “all inside, all outside”, and the pollinaza and gallinaza are destined to feed the cattle. Depending on the type and the characteristics of the bed, it is possible to calculate an approximated weight of 13,9 kg. by square meter of bird farm surface.

With foundation in Article 14, fraction VI, of the Federal Law of Transparency and Access to the Governmental Public Information, the following paragraphs have been blocked:

Justification of the blockade (p. 6, paragraph 4):

***In the Mexican market, two types of products are accepted: pollinaza and gallinaza, which has been consolidated as a production system, considering that near 90% of the feces are used as ruminant’s feed, with prices reaching near those of cereal grains, the rest is used in agriculture.

With foundation in Article 14, fraction VI, of the Federal Law of Transparency and Access to the Governmental Public Information, the following paragraphs have been blocked:

Justification of the blockade (p. 6, paragraph 5):

***The use of the animal feces like source of high nutrients supply, it obeys mainly to its high content of mineral matter and non-protein nitrogen. In general, nitrogen is concentrated in greater amount in bird feces. What is doubtless, it is that the feces are raw material available all the year long for animal feeding, especially bovines.

The FAO (1980) made a description of the physical composition of pollinaza as it is detailed next:

Feces 62%

Bed 31%

Wasted Feed 3%

Feathers 2%

Unknown ingredients related to fresh matter 2%

Source: The FAO. Feed from Wastes Animal: State of knowledge, Production animal and Health, to paper 18. Rome, Italy 1980.

Conclusion:

****Making public the information that has been eliminated of the report, it would open the door for those in the grain business to use it for their benefit and by pressing the government/the authority to establish a NOM banning such products as ruminant feed. This would bring/cause an important alteration in the commercialization of these products nationwide, which in turn would remarkably increase the production costs of the cattle in feed lots. Today, we foresee escalating grains prices at medium term, originated by its use in the ethanol production; this would aggravate the situation and force a NOM as described before, which in addition, if our sanitary status with respect to the BSE is considered low, it would be obviously excessive cost and highly harmful for the producer of birds and cattle. It is why, that it was decided to block the reference information.

With foundation in Article 14, fraction VI, of the Federal Law of Transparency and Access to the Governmental Public Information, the following paragraphs have been blocked:

Justification of the blockade (p. 12, paragraph 3):

***During the period between 1996 to 2003 years in which, considering the long period of incubation of the BSE, the disease was already present in the United States of America and Canada, Mexico as usual, imported considerable amounts of calves destined for dairy production. In the same term “bullfight” bulls from Spain were imported once Europe reached a free status from FMD, same that allowed the import of some cattle for reproduction from other European countries, with exception of the United Kingdom and Ireland, countries in which BSE already existed.

***In all the cases these imports were immediately stopped even before the confirmation of BSE in those countries, nevertheless, as already indicated, the ample period of incubation of the disease, those imports are looked as of certain risk, even though in that moment they were not.

***The nonexistence of a national animal identification and traceability system at that time made it impossible to establish the destiny of most of those animals and to even know if they have been eliminated at the end of its productive life. It is possible to indicate that the recent imports of heifers coming from the United States of America and in the near future from Canada, new requirements and actions that guarantee their traceability and other measures to mitigate the BSE risk, are in place.

***Even though during the administration of the Lic. Vicente Fox, the SAGARPA made a concerted effort to establish the National System of Individual Cattle Identification (SINIIGA), the magnitude, cost and coverage of the project, its conclusion in the short and medium term are way far distant, what implies that it will be long time before Mexico can count on a suitable (working) national system of identification and traceability of animals and products of origin animal.

***The blockade of the above paragraph obeys to the convenience of not exposing to the Federal Government to unnecessarily critics that even though funded, it would not contribute to the solution of a problem that, although is of urgent attention, by its magnitude and cost, it exceeds in much, the present capacities as much of the Government, like of the National Cattlemen Sector. The critic would sustain in that what it is said in such paragraph is purely speculative, without possibility of corroborating it documentarily.

END...

Hola Amigo Terry,

Finally, here is a translation - if you can call it that - i'm not happy with it but guess that some paragraphs are very literally translated (poorest job i have ever done translating a document), please read it and if something is not clear enough or not right just let me know it and i'll correct it...

If you don't find anything of importance; if it is to vague and shows that they have done nothing about it; if somehow it gives you the impresion that they don't know a thing and are trying to cover their butts in a very stupid way;...yea! you got the right impression!!

All they are saying it's a "mea culpa" and we ought to do this and that; we don't know how they came in or where they are; we are looking into it; we screwed up all the BSE testing and we don't know how to do it right; it is too costly and we don't have the money; we didn't do it, past administration did it; we are trying to fix it; etc.,

All of the above and more, but we are following OIE rules, we have NO BSE anywhere and risk is extremely low or null, but CATTLEMEN WIL BE COMPENSATED!!

Conclusion- they are a bunch of murderers and me a national security threat for having them to admit it!! .....Oh my Lord!

snip...end (tss)

Have a wonderful weekend and our best regards,

xxxxxxxxxxxxxxxxxxxxxxx

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


Mexico Bovine Spongiform Encephalopathy BSE TSE Prion Surveillance ???


WEDNESDAY, JUNE 13, 2012 

MEXICO IS UNDER or MIS DIAGNOSING CREUTZFELDT JAKOB DISEASE AND OTHER PRION DISEASE SOME WITH POSSIBLE nvCJD


Conclusions The incidence of CJD in the health area of Meixoeiro Hospital is three times higher than expected. The hypothesis that at least some cases of sCJD are apparently because of covert transmission or zoonosis events should not be formally refuted and might explain the high rate found. 

snip...see full text ; 


GERMANY BSE GBR July 2000

5. CONCLUSION ON THE GEOGRAPHICAL BSE-RISK

5.1 The current GBR

The current geographical BSE-risk (GBR) level is III, i.e. it is likely that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent but it is not confirmed.

The current surveillance system is depending on notification of suspects, i.e. it is passive, and therefore not able to detect all clinical BSE cases. The probability that BSE is confirmed in Germany within the next years is significant, in particular if active surveillance would improve the performance of the surveillance system.

5.2 The expected development of the GBR

Assuming that measures in place continue to be appropriately implemented and no new external challenge occurs, the probability that cattle are (pre-clinically or clinically) infected with the BSE-agent will remain as it is.

5.3 Recommendations for influencing the future GBR

The following measures would lead to a decrease of the GBR:

• Exclusion of SRM and fallen stock from rendering and feed processing. (According to 2000/418/EC foreseen for 01/10/2000)

• Application of appropriate rendering (EU standards (133/20/3)) to all materials (according to 99/534/EC foreseen for July 2000).

• Measures to further reduce the risk of cross-contamination, ideally a prohibition of feeding MMBM to all farmed animals.

Results from an improved intensive surveillance program, targeting at risk subpopulations such as adult cattle in fallen stock or in emergency slaughter, could help to verify the current assessment.


GAIN Report - E35023 Page 3 of 3

UNCLASSIFIED USDA Foreign Agricultural Service

Evolution of BSE in the EU-25

BSE cases in the European Union (EU) continued to decrease to about 830 cases in 2004, from 1369 cases in 2003. Except for Germany, which had a small increase from 54 BSE infected cows in 2003 to 59 in 2004, all EU-15 member states identified fewer cases, with the United Kingdom dropping from 612 cases to 322 cases. In the New Member States (NMS), the situation is mixed, although the overall number of BSE cases is much lower.

More background information on the BSE/TSE situation in the EU can be found at the Commission website at 

http://europa.eu.int/comm/food/food/biosafety/bse/index_en.htm 

or on the USEU website at 

http://www.useu.be/agri/srm.html.

Number of reported cases of BSE

2002 2003 2004

Austria 0 0..

Belgium 38 15 11

Czech Republic 2 4 7

Denmark 3 2 1

Finland 0 0..

France 239 137 54

Germany 106 54 59

Greece 0 0..

Ireland 333 183 126

Italy 38 29 7

Netherlands 24 19 6

Poland 5 11 1

Portugal 86 133 92

Slovakia 6 2 7

Slovenia 1 1 2

Spain 127 167 131

United Kingdom 1,144 612 322

Total BSE cases 2,152 1,369 826

Germany date as of 30 November 2004

UK data are preliminar

.. Negligible

Source: OIE


MONDAY, DECEMBER 1, 2014 

Germany Bovine Spongiform Encephalopathy BSE CJD TSE Prion disease A Review December 1, 2014


From: Terry S. Singeltary Sr.

Sent: Wednesday, February 26, 2014 7:54 AM

To: BSE-L@LISTS.AEGEE.ORG

Subject: [BSE-L] GERMANY REPORTS ANOTHER CASE OF ATYPICAL BSE (H-TYPE)

Bovine spongiform encephalopathy,

Germany

Information received on 25/02/2014 from Dr. Karin Schwabenbauer, Ministerial Dirigentin and Chief Veterinary Officer , Directorate of Animal Health, Animal Welfare, Bundesministerium für Ernährung, Landwirtschaft und Verbraucherschutz (BMELV) , Bonn, Germany

Summary

Report type Immediate notification (Final report) Date of start of the event 30/01/2014 Date of pre-confirmation of the event 04/02/2014 Report date 25/02/2014 Date submitted to OIE 25/02/2014 Date event resolved 13/02/2014 Reason for notification Reoccurrence of a listed disease Date of previous occurrence 16/01/2014 Manifestation of disease Sub-clinical infection Causal agent Prion (atypical BSE H-type) Nature of diagnosis Laboratory (advanced) This event pertains to the whole country

New outbreaks (1)

Outbreak 1 Prädikow, Prötzel, Märkisch-Oderland, BRANDENBURG Date of start of the outbreak 30/01/2014 Outbreak status Resolved (13/02/2014) Epidemiological unit Farm Affected animals Species Susceptible Cases Deaths Destroyed Slaughtered Cattle 714 1 0 1 0

Summary of outbreaks Total outbreaks: 1 Total animals affected Species Susceptible Cases Deaths Destroyed Slaughtered Cattle 714 1 0 1 0

Outbreak statistics Species Apparent morbidity rate Apparent mortality rate Apparent case fatality rate Proportion susceptible animals lost* Cattle 0.14% 0.00% 0.00% 0.14%

*Removed from the susceptible population through death, destruction and/or slaughter
Epidemiology Source of the outbreak(s) or origin of infection Unknown or inconclusive

Epidemiological comments As part of the German targeted bovine spongiform encephalopathy (BSE) surveillance system, a BSE-case classified as atypical (H-type) was identified in a cow at slaughter. An epidemiological investigation of the event was conducted. The summary of the event is as follows: - The cow was slaughtered on 30.01.2014 at the age of eleven years and four months without clinical signs. - Results from the immuno blot tests at the NRL (Friedrich Loeffler-Institute) confirmed the animal positive for atypical BSE of the H-type, a very rare form of the disease not associated with feeding. - The animal´s carcass has been destroyed. The identified animal did not enter the food channels; at no time it presented any risk to human health. - The epidemiological investigation identified eight offspring cattle, three of which were already slaughtered, one of which has been fallen and four of which have been traded to another Member State. The tracing of the bovines born on the farm from one year before until one year after the birth of the identified cow revealed 371 bovines (177 have been already slaughtered, 63 were fallen stock, 3 have been traded within the territory of Germany, 127 have been traded to other States, one has been culled and destroyed). The OIE does not recognize an atypical form of BSE as a distinct entity for the purpose of its international standards; it is not mentioned in the OIE Terrestrial Animal Health Code, which does not distinguish between different forms of BSE.

Control measures Measures applied Movement control inside the country Screening Disinfection of infected premises/establishment(s) Modified stamping out No vaccination No treatment of affected animals
Measures to be applied No other measures

Diagnostic test results Laboratory name and type Species Test Test date Result Friedrich Loeffler-Institute (National laboratory) Cattle western blot 04/02/2014 Positive

Future Reporting The event is resolved. No more reports will be submitted.

Map of outbreak locations

Saturday, January 18, 2014

GERMANY DETECTS A CASE OF ATYPICAL BSE Jan 17, 2014

Saturday, January 18, 2014

Bovine spongiform encephalopathy ,Germany Information received on 17/01/2014

Wednesday, February 26, 2014

GERMANY REPORTS ANOTHER CASE OF ATYPICAL BSE (H-TYPE)

Saturday, January 18, 2014

GERMANY DETECTS A CASE OF ATYPICAL BSE Jan 17, 2014

Saturday, January 18, 2014

Bovine spongiform encephalopathy ,Germany Information received on 17/01/2014




THERE HAS BEEN LITERALLY 100s if not 1000s OF TONNAGE OF BANNED MAD COW FEED FED OUT INTO COMMERCE AS LATE AS 10 YEARS POST FEED BAN 2007, AND AS RECENTLY AS LAST YEAR 2016 the breach of the mad cow feed ban continued. these are the facts...


 P56 Detection of classical BSE prions in the ileal Peyer’s patch of unweaned calves from two months after oral challenge

Ivett Ackermann1, Dr. Anne Balkema-Buschmann1, Dr. Reiner Ulrich2, Dr. Kerstin Tauscher2, Dr. Christine Fast1, Dr. Markus Keller1, James C. Shawulu1, Prof. Dr. Martin H. Groschup1 1Friedrich-Loeffler-Institut, INEID, Greifswald-Insel Riems, Germany, 2Friedrich-Loeffler-Institut, ATB, Greifswald-Insel Riems, Germany

Aims: In cattle the ileal Peyer’s patch (IPP) functions as the entry port for classical BSE prions, as these were detectable from 4 months post experimental challenge of cattle that were 4 to 6 months of age at infection. However, the earliest time point of prion detection in bovines may also be a matter of age, as a recently reported experiment indicated that BSE challenged unweaned lambs are more susceptible than older weaned lambs or adults. To prove this hypothesis and to clarify the dynamics of pathological prion protein (PrPSc) spread during the first 8 months of infection, young unweaned calves were challenged orally with classical BSE prions and the progress of the infection was monitored by assessing the ileal Peyer’s patches to determine – as a proxy of their susceptibility - the earliest time point at which pathological prion protein (PrPSc) and prion infectivity are detectable.

Methods: 18 unweaned Simmental calves aged 4 to 6 weeks were orally challenged with classical BSE, while 2 calves served as negative controls. The animals were euthanized and necropsied at predetermined time points of 1 week as well as 2, 4, 6 and 8 months post infection. To serve as positive controls 2 infected cattle were kept until the development of clinical symptoms of BSE. For each of the 18 infected and 2 negative control calves, samples of the ileal Peyer’s patch were examined by immunohistochemistry (IHC), protein misfolding cyclic amplification (PMCA) and transgenic Tgbov XV mouse bioassay.

Results: In the ileal Peyer’s patches newly generated BSE prions were detectable as early as 2 months post infection (mpi) by PMCA and transgenic mouse bioassay. From 4 mpi, PrPSc accumulation was detectable by IHC in tingible body macrophages (TBMs) of the IPP follicles and already in follicular dendritic cells (FDCs). The positive control animals developed clinical signs of BSE after incubation periods of 32 mpi and 36 mpi, respectively.

Conclusions: The earlier detection of BSE prions in the ileal Peyer’s patches may result from using improved assay protocols for the sample analysis. However, the presented data rather indicate an earlier propagation of BSE prions in the ileal Peyer’s patches as a result of challenging unweaned calves. This is also supported by the observation that the 2 BSE-challenged control animals came down after short incubation times.


P.108: Successful oral challenge of adult cattle with classical BSE

Sandor Dudas1,*, Kristina Santiago-Mateo1, Tammy Pickles1, Catherine Graham2, and Stefanie Czub1 1Canadian Food Inspection Agency; NCAD Lethbridge; Lethbridge, Alberta, Canada; 2Nova Scotia Department of Agriculture; Pathology Laboratory; Truro, Nova Scotia, Canada

Classical Bovine spongiform encephalopathy (C-type BSE) is a feed- and food-borne fatal neurological disease which can be orally transmitted to cattle and humans. Due to the presence of contaminated milk replacer, it is generally assumed that cattle become infected early in life as calves and then succumb to disease as adults. Here we challenged three 14 months old cattle per-orally with 100 grams of C-type BSE brain to investigate age-related susceptibility or resistance. During incubation, the animals were sampled monthly for blood and feces and subjected to standardized testing to identify changes related to neurological disease. At 53 months post exposure, progressive signs of central nervous system disease were observed in these 3 animals, and they were euthanized. Two of the C-BSE animals tested strongly positive using standard BSE rapid tests, 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. 

***Our study demonstrates susceptibility of adult cattle to oral transmission of classical BSE. 

We are further examining explanations for the unusual disease presentation in the third challenged animal.


***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.

P.86: Estimating the risk of transmission of BSE and scrapie to ruminants and humans by protein misfolding cyclic amplification

Morikazu Imamura, Naoko Tabeta, Yoshifumi Iwamaru, and Yuichi Murayama National Institute of Animal Health; Tsukuba, Japan

To assess the risk of the transmission of ruminant prions to ruminants and humans at the molecular level, we investigated the ability of abnormal prion protein (PrPSc) of typical and atypical BSEs (L-type and H-type) and typical scrapie to convert normal prion protein (PrPC) from bovine, ovine, and human to proteinase K-resistant PrPSc-like form (PrPres) using serial protein misfolding cyclic amplifi- cation (PMCA).

Six rounds of serial PMCA was performed using 10% brain homogenates from transgenic mice expressing bovine, ovine or human PrPC in combination with PrPSc seed from typical and atypical BSE- or typical scrapie-infected brain homogenates from native host species. In the conventional PMCA, the conversion of PrPC to PrPres was observed only when the species of PrPC source and PrPSc seed matched. However, in the PMCA with supplements (digitonin, synthetic polyA and heparin), both bovine and ovine PrPC were converted by PrPSc from all tested prion strains. On the other hand, human PrPC was converted by PrPSc from typical and H-type BSE in this PMCA condition.

Although these results were not compatible with the previous reports describing the lack of transmissibility of H-type BSE to ovine and human transgenic mice, 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.


P.170: Potential detection of oral transmission of H type atypical BSE in cattle using in vitro conversion

***P.170: Potential detection of oral transmission of H type atypical BSE in cattle using in vitro conversion

Sandor Dudas, John G Gray, Renee Clark, and Stefanie Czub Canadian Food Inspection Agency; Lethbridge, AB Canada

Keywords: Atypical BSE, oral transmission, RT-QuIC

The detection of bovine spongiform encephalopathy (BSE) has had a significant negative impact on the cattle industry worldwide. In response, governments took actions to prevent transmission and additional threats to animal health and food safety. While these measures seem to be effective for controlling classical BSE, the more recently discovered atypical BSE has presented a new challenge. To generate data for risk assessment and control measures, we have challenged cattle orally with atypical BSE to determine transmissibility and mis-folded prion (PrPSc) tissue distribution. Upon presentation of clinical symptoms, animals were euthanized and tested for characteristic histopathological changes as well as PrPSc deposition.

The H-type challenged animal displayed vacuolation exclusively in rostral brain areas but the L-type challenged animal showed no evidence thereof. To our surprise, neither of the animals euthanized, which were displaying clinical signs indicative of BSE, showed conclusive mis-folded prion accumulation in the brain or gut using standard molecular or immunohistochemical assays. To confirm presence or absence of prion infectivity, we employed an optimized real-time quaking induced conversion (RT-QuIC) assay developed at the Rocky Mountain Laboratory, Hamilton, USA.

Detection of PrPSc was unsuccessful for brain samples tests from the orally inoculated L type animal using the RT-QuIC. It is possible that these negative results were related to the tissue sampling locations or that type specific optimization is needed to detect PrPSc in this animal. We were however able to consistently detect the presence of mis-folded prions in the brain of the H-type inoculated animal. Considering the negative and inconclusive results with other PrPSc detection methods, positive results using the optimized RT-QuIC suggests the method is extremely sensitive for H-type BSE detection. This may be evidence of the first successful oral transmission of H type atypical BSE in cattle and additional investigation of samples from these animals are ongoing.




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?


USDA announces Alabama case of Atypical L-type BASE Bovine Spongiform Encephalopathy and BANNED FEED

look at the table and you'll see that as little as 1 mg (or 0.001 gm) caused 7% (1 of 14) of the cows to come down with BSE; 

Risk of oral infection with bovine spongiform encephalopathy agent in primates

Corinne Ida Lasmézas, Emmanuel Comoy, Stephen Hawkins, Christian Herzog, Franck Mouthon, Timm Konold, Frédéric Auvré, Evelyne Correia, Nathalie Lescoutra-Etchegaray, Nicole Salès, Gerald Wells, Paul Brown, Jean-Philippe Deslys 

Summary The uncertain extent of human exposure to bovine spongiform encephalopathy (BSE)--which can lead to variant Creutzfeldt-Jakob disease (vCJD)--is compounded by incomplete knowledge about the efficiency of oral infection and the magnitude of any bovine-to-human biological barrier to transmission. We therefore investigated oral transmission of BSE to non-human primates. We gave two macaques a 5 g oral dose of brain homogenate from a BSE-infected cow. One macaque developed vCJD-like neurological disease 60 months after exposure, whereas the other remained free of disease at 76 months. On the basis of these findings and data from other studies, we made a preliminary estimate of the food exposure risk for man, which provides additional assurance that existing public health measures can prevent transmission of BSE to man. 

snip... 

BSE bovine brain inoculum

100 g 10 g 5 g 1 g 100 mg 10 mg 1 mg 0·1 mg 0·01 mg

Primate (oral route)* 1/2 (50%)

Cattle (oral route)* 10/10 (100%) 7/9 (78%) 7/10 (70%) 3/15 (20%) 1/15 (7%) 1/15 (7%)

RIII mice (ic ip route)* 17/18 (94%) 15/17 (88%) 1/14 (7%)

PrPres biochemical detection

The comparison is made on the basis of calibration of the bovine inoculum used in our study with primates against a bovine brain inoculum with a similar PrPres concentration that was

inoculated into mice and cattle.8 *Data are number of animals positive/number of animals surviving at the time of clinical onset of disease in the first positive animal (%). The accuracy of

bioassays is generally judged to be about plus or minus 1 log. ic ip=intracerebral and intraperitoneal.

Table 1: Comparison of transmission rates in primates and cattle infected orally with similar BSE brain inocula 

Published online January 27, 2005


It is clear that the designing scientists must

also have shared Mr Bradley's surprise at the results because all the dose

levels right down to 1 gram triggered infection. 


6. It also appears to me that Mr Bradley's answer (that it would take less than say 100 grams) was probably given with the benefit of hindsight; particularly if one considers that later in the same answer Mr Bradley expresses his surprise that it could take as little of 1 gram of brain to cause BSE by the oral route within the same species. This information did not become available until the "attack rate" experiment had been completed in 1995/96. This was a titration experiment designed to ascertain the infective dose. A range of dosages was used to ensure that the actual result was within both a lower and an upper limit within the study and the designing scientists would not have expected all the dose levels to trigger infection. The dose ranges chosen by the most informed scientists at that time ranged from 1 gram to three times one hundred grams.

***It is clear that the designing scientists must have also shared Mr Bradley's surprise at the results because all the dose levels right down to 1 gram triggered infection. 



2) Infectious dose:

To cattle: 1 gram of infected brain material (by oral ingestion) 


***********CJD REPORT 1994 increased risk for consumption of veal and venison and lamb***********

CREUTZFELDT JAKOB DISEASE SURVEILLANCE IN THE UNITED KINGDOM THIRD ANNUAL REPORT AUGUST 1994

Consumption of venison and veal was much less widespread among both cases and controls. For both of these meats there was evidence of a trend with increasing frequency of consumption being associated with increasing risk of CJD. (not nvCJD, but sporadic CJD...tss)

These associations were largely unchanged when attention was restricted to pairs with data obtained from relatives. ...

Table 9 presents the results of an analysis of these data.

There is STRONG evidence of an association between ‘’regular’’ veal eating and risk of CJD (p = .0.01).

Individuals reported to eat veal on average at least once a year appear to be at 13 TIMES THE RISK of individuals who have never eaten veal.

There is, however, a very wide confidence interval around this estimate. There is no strong evidence that eating veal less than once per year is associated with increased risk of CJD (p = 0.51).
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 ;


The Presence of Disease-Associated Prion Protein in Skeletal Muscle of Cattle Infected with Classical Bovine Spongiform Encephalopathy 


Hiroyuki OKADA,1,* Kohtaro MIYAZAWA,1 Shigeo FUKUDA,2 Yoshifumi IWAMARU,1 Morikazu IMAMURA,1 Kentaro MASUJIN,1 Yuichi MATSUURA,1 Takashi FUJII,2 Kei FUJII,2 Soichi KAGEYAMA,2 Miyako YOSHIOKA,1 Yuichi MURAYAMA,1 and Takashi YOKOYAMA1



Infectivity in Skeletal Muscle of Cattle with Atypical Bovine Spongiform Encephalopathy


Silvia Suardi , Chiara Vimercati , Cristina Casalone , Daniela Gelmetti, Cristiano Corona, Barbara Iulini, Maria Mazza, Guerino Lombardi, Fabio Moda, Margherita Ruggerone, Ilaria Campagnani, Elena Piccoli, Marcella Catania, [ ... ], Fabrizio Tagliavini [ view all ] Published: February 21, 2012 

https://doi.org/10.1371/journal.pone.0031449

The present data offer novel information on the tropism of the BASE agent and highlight relevant public health issues. While the transmission barrier for classical BSE is high in most species, BASE prions are readily transmissible to a variety of mammals including non-human primates [11]–[13], [35]. Accordingly, the possibility of spreading of BASE prions through skeletal muscle to other species should be taken into account and evaluated in risk analysis studies.



Scientists investigate origin of isolated BSE cases 

The European response to bovine spongiform encephalopathy (BSE) after the crisis of the 1980s has significantly reduced prevalence of the disease in cattle. However, isolated cases are still being reported in the EU and for this reason the European Commission asked EFSA to investigate their origin.

The key measure for controlling BSE in the EU is a ban on the use of animal proteins in livestock feed. This is because BSE can be transmitted to cattle through contaminated feed, mainly in the first year of life.

Sixty cases of classical BSE have been reported in cattle born after the EU ban was enforced in 2001. None of these animals entered the food chain. Classical BSE is the type of BSE transmissible to humans. The Commission asked EFSA to determine if these cases were caused by contaminated feed or whether they occurred spontaneously, i.e. without an apparent cause.

EFSA experts concluded that contaminated feed is the most likely source of infection. This is because the infectious agent that causes BSE has the ability to remain active for many years. Cattle may have been exposed to contaminated feed because the BSE infectious agent was present where feed was stored or handled. A second possibility is that contaminated feed ingredients may have been imported from non-EU countries.

Experts could not rule out other causes due to the difficulty of investigating individual cases. Some constraints are the long incubation period of the disease and the lack of detailed information available from farms at the time of the trace-back investigation.

EFSA experts made a series of recommendations to maintain and strengthen the EU monitoring and reporting system, and to evaluate new scientific data that become available.

The European response to BSE

The coordinated European response to BSE has succeeded in reducing the prevalence of the disease. Between 2005 and 2015 about 73,000,000 cattle were tested for BSE in the EU, out of which 60 born after the ban tested positive for classical BSE. The number of affected animals rises to 1,259 if cattle born before the ban are included. The number of classical BSE cases has dropped significantly in the EU over time, from 554 cases reported in 2005 to just two in 2015 (both animals born after the ban). Moreover the EU food safety system is designed to prevent the entry of BSE-contaminated meat into the food chain.


10 years post mad cow feed ban August 1997 

10,000,000+ LBS. of PROHIBITED BANNED MAD COW FEED I.E. BLOOD LACED MBM IN COMMERCE USA 2007 

Date: March 21, 2007 at 2:27 pm PST 

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINES -- CLASS II PRODUCT 

Bulk cattle feed made with recalled Darling's 85% Blood Meal, Flash Dried, Recall # V-024-2007 CODE Cattle feed delivered between 01/12/2007 and 01/26/2007 RECALLING FIRM/MANUFACTURER Pfeiffer, Arno, Inc, Greenbush, WI. by conversation on February 5, 2007. 

Firm initiated recall is ongoing. 

REASON Blood meal used to make cattle feed was recalled because it was cross- contaminated with prohibited bovine meat and bone meal that had been manufactured on common equipment and labeling did not bear cautionary BSE statement. 

VOLUME OF PRODUCT IN COMMERCE 42,090 lbs. DISTRIBUTION WI 

___________________________________ 

PRODUCT 

Custom dairy premix products: 

MNM ALL PURPOSE Pellet, 

HILLSIDE/CDL Prot- Buffer Meal, 

LEE, M.-CLOSE UP PX Pellet, 

HIGH DESERT/ GHC LACT Meal, 

TATARKA, 

M CUST PROT Meal, 

SUNRIDGE/CDL PROTEIN Blend, 

LOURENZO, K PVM DAIRY Meal, 

DOUBLE B DAIRY/GHC LAC Mineral, 

WEST PIONT/GHC CLOSEUP Mineral, 

WEST POINT/GHC LACT Meal, 

JENKS, 

J/COMPASS PROTEIN Meal, 

COPPINI - 8# SPECIAL DAIRY Mix, 

GULICK, L-LACT Meal (Bulk), 

TRIPLE J - PROTEIN/LACTATION, 

ROCK CREEK/GHC MILK Mineral, 

BETTENCOURT/GHC S.SIDE MK-MN, 

BETTENCOURT #1/GHC MILK MINR, 

V&C DAIRY/GHC LACT Meal, 

VEENSTRA, F/GHC LACT Meal, 

SMUTNY, A- BYPASS ML W/SMARTA, 

Recall # V-025-2007 

CODE The firm does not utilize a code - only shipping documentation with commodity and weights identified. 

RECALLING FIRM/MANUFACTURER Rangen, Inc, Buhl, ID, by letters on February 13 and 14, 2007. 

Firm initiated recall is complete. 

REASON Products manufactured from bulk feed containing blood meal that was cross contaminated with prohibited meat and bone meal and the labeling did not bear cautionary BSE statement. 

VOLUME OF PRODUCT IN COMMERCE 9,997,976 lbs. 

DISTRIBUTION ID and NV 

END OF ENFORCEMENT REPORT FOR MARCH 21, 2007 



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 ***

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


16 years post mad cow feed ban August 1997 2013 

Sunday, December 15, 2013 

FDA PART 589 -- SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED VIOLATIONS OFFICIAL ACTION INDICATED OIA UPDATE DECEMBER 2013 UPDATE 


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 


17 years post mad cow feed ban August 1997 

Monday, October 26, 2015 

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


TUESDAY, 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


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 challenge="" groups="" month="" pigs="" remaining="" the="">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 5="" 6="" at="" by="" detected="" eia.="" examined="" group="" in="" intracranial="" least="" lymphoid="" month="" months="" of="" one="" pigs="" positive="" prpsc="" quic="" the="" tissues="" was="">6 months group, 5/6 pigs in the oral <6 4="" and="" group="" months="" 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



Article Induction of IAPP amyloid deposition and associated diabetic abnormalities by a prion-like mechanism


 View ORCID ProfileAbhisek Mukherjee, Diego Morales-Scheihing, Natalia Salvadores, Ines Moreno-Gonzalez, Cesar Gonzalez, View ORCID ProfileKathleen Taylor-Presse, View ORCID ProfileNicolas Mendez, Mohammad Shahnawaz, View ORCID ProfileA. Osama Gaber, View ORCID ProfileOmaima M. Sabek, View ORCID ProfileDaniel W. Fraga, View ORCID ProfileClaudio Soto DOI: 10.1084/jem.20161134 | Published August 1, 2017

ArticleFigures & DataInfoMetrics Preview PDF Abstract

Although a large proportion of patients with type 2 diabetes (T2D) accumulate misfolded aggregates composed of the islet amyloid polypeptide (IAPP), its role in the disease is unknown. Here, we show that pancreatic IAPP aggregates can promote the misfolding and aggregation of endogenous IAPP in islet cultures obtained from transgenic mouse or healthy human pancreas. Islet homogenates immunodepleted with anti-IAPP–specific antibodies were not able to induce IAPP aggregation. Importantly, intraperitoneal inoculation of pancreatic homogenates containing IAPP aggregates into transgenic mice expressing human IAPP dramatically accelerates IAPP amyloid deposition, which was accompanied by clinical abnormalities typical of T2D, including hyperglycemia, impaired glucose tolerance, and a substantial reduction on β cell number and mass. Finally, induction of IAPP deposition and diabetic abnormalities were also induced in vivo by administration of IAPP aggregates prepared in vitro using pure, synthetic IAPP. Our findings suggest that some of the pathologic and clinical alterations of T2D might be transmissible through a similar mechanism by which prions propagate in prion diseases.

Submitted: 19 July 2016 Revision received 24 March 2017 Accepted: 19 June 2017 http://www.rupress.org/terms/https://creativecommons.org/licenses/by-nc-sa/4.0/ This article is distributed under the terms of an Attribution–Noncommercial–Share Alike–No Mirror Sites license for the first six months after the publication date (see http://www.rupress.org/terms/). After six months it is available under a Creative Commons License (Attribution–Noncommercial–Share Alike 4.0 International license, as described at https://creativecommons.org/licenses/by-nc-sa/4.0/).

View Full Text © 2017 Mukherjee et al.


TUESDAY, AUGUST 1, 2017 

Could Insulin be contaminated with and potentially spread, Transmissible Spongiform Encephalopathy TSE Prion, what if?


TUESDAY, AUGUST 1, 2017 

Could diabetes spread like mad cow disease?



i remember reading a lot about diabetes and tse prion during the BSE Inquiry days. i may have to go back and study that a bit closer.

also, interestingly, in the recent study with cwd and macaque, i also remember reading, In four animals wasting was observed, two of those had confirmed diabetes.


THURSDAY, AUGUST 3, 2017 

BSE INQUIRY DFA 18 COSMETICS FDA OVERSIGHT WARNING The Honorable Frank Pallone, Jr.


TUESDAY, AUGUST 1, 2017 

BSE INQUIRY DFA 17 Medicines and medical devices


TUESDAY, APRIL 18, 2017 

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


TUESDAY, MARCH 28, 2017 

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


2017

TUESDAY, JULY 18, 2017 

USDA announces Alabama case of Bovine Spongiform Encephalopathy Alabama


SUNDAY, JULY 30, 2017 

*** PRION2017 Low levels of classical BSE infectivity in rendered fat tissue



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


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.***


Wednesday, December 21, 2016 

TRANSMISSION, DIFFERENTIATION, AND PATHOBIOLOGY OF TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES 2016 ANNUAL REPORT ARS RESEARCH 


Tuesday, September 06, 2016

A comparison of classical and H-type bovine spongiform encephalopathy associated with E211K prion protein polymorphism in wild type and EK211 cattle following intracranial inoculation


Saturday, July 23, 2016

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


TUESDAY, JULY 18, 2017 

MINK FARMING USA TRANSMISSIBLE MINK ENCEPHALOPATHY TSE PRION DISEASE SURVEILLANCE AND TESTING



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

 Monday, June 20, 2016

Specified Risk Materials SRMs BSE TSE Prion Program

Thursday, June 9, 2016

Advisory Committee; Transmissible Spongiform Encephalopathies Advisory Committee; Termination

Saturday, April 16, 2016

APHIS [Docket No. APHIS-2016-0029] Secretary's Advisory Committee on Animal Health; Meeting May 2, 2016, and June 16, 2016 Singeltary Submission


WEDNESDAY, JULY 26, 2017 

APHIS USDA Emerging Animal Disease Preparedness and Response Plan July 2017


THURSDAY, JUNE 22, 2017 

World Organisation for Animal Health (OIE) to establish liaison office in College Station, Texas


MONDAY, JANUARY 4, 2016 

Long live the OIE, or time to close the doors on a failed entity?


WEDNESDAY, MARCH 11, 2015 

OIE and Centers for Disease Control and Prevention Reinforce Collaboration


MONDAY, MAY 05, 2014

Member Country details for listing OIE CWD 2013 against the criteria of Article 1.2.2., the Code Commission recommends consideration for listing

OIE STILL FLOUNDERING WITH TSE PRION DISEASE, letting it spread around the globe with the bse mrr policy, and still ignoring cwd, and making atypical scrapie a legal trading commodity.


THURSDAY, MAY 30, 2013 

World Organization for Animal Health (OIE) has upgraded the United States' risk classification for mad cow disease to "negligible" from "controlled", and risk further exposing the globe to the TSE prion mad cow type disease


TUESDAY, JULY 17, 2012 

O.I.E. BSE, CWD, SCRAPIE, TSE PRION DISEASE Final Report of the 80th General Session, 20 - 25 May 2012


BSE TSE PRION USDA OIE NEEDLESS CONFLICT


2001 FDA CJD TSE Prion Singeltary Submission

BSE YOUNGEST DOCUMENTED TO DATE 20 MONTHS

1992 20 26 15.02 16.02

1.6. YOUNGEST AND OLDEST CASES BY YEAR OF ONSET (FOR PASSIVE SURVEILLANCE CASES) AND ON YEAR OF SLAUGHTER (FOR ACTIVE SURVEILLANCE CASES) AS AT 03/09/2007 NB The last case in an animal aged 30 months or less was in 1996

YR OF ONSET AGE YOUNGEST CASE (mths) AGE 2nd YOUNGEST CASE (mths) AGE 2nd OLDEST (yrs.mths) OLDEST CASE (yrs.mths)

1986 30 33 5.03 5.07

1987 30 31 9.09 10

1988 24 27 10.02 11.01(2)

1989 21 24(4) 12(2) 15.04

1990 24(2) 26 13.03 14

1991 24 26(3) 14.02 17.05

1992 20 26 15.02 16.02

1993 29 30(3) 14.1 18.1

1994 30(2) 31(2) 14.05 16.07

995 24 32 14.09 15.05

1996 29 30 15.07 17.02

1997 37(7) 38(3) 14.09 15.01

1998 34 36 14.07 15.05

1999 39(2) 41 13.07 13.1

2000 40 42 17.08 19.09

2001 45 48 16.01 20.08

2002 47 48(2) 18.04 22.07

2003 46 49 18.07(2) 20.06

2004 49 52 17.04 22.07

2005 36 38 18.01 19.04

2006 48 58 17.05 19.09

2007 81(2) 88 15(02) 17.03

PAGE 5


Tracking spongiform encephalopathies in North America

Xavier Bosch

Published: August 2003


Summary;

“My name is Terry S Singeltary Sr, and I live in Bacliff, Texas. I lost my mom to hvCJD (Heidenhain variant CJD) and have been searching for answers ever since. What I have found is that we have not been told the truth. CWD in deer and elk is a small portion of a much bigger problem.”

49-year-old Singeltary is one of a number of people who have remained largely unsatisfied after being told that a close relative died from a rapidly progressive dementia compatible with spontaneous Creutzfeldt-Jakob disease (CJD). So he decided to gather hundreds of documents on transmissible spongiform encephalopathies (TSE) and realised that if Britons could get variant CJD from bovine spongiform encephalopathy (BSE), Americans might get a similar disorder from chronic wasting disease (CWD) the relative of mad cow disease seen among deer and elk in the USA. Although his feverish search did not lead him to the smoking gun linking CWD to a similar disease in North American people, it did uncover a largely disappointing situation.

Singeltary was greatly demoralised at the few attempts to monitor the occurrence of CJD and CWD in the USA. Only a few states have made CJD reportable. Human and animal TSEs should be reportable nationwide and internationally, he complained in a letter to the Journal of the American Medical Association (JAMA 2003; 285: 733). "I hope that the CDC does not continue to expect us to still believe that the 85% plus of all CJD cases which are sporadic are all spontaneous, without route or source."

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.


Until recently, CWD was thought to be confined to the wild in a small region in Colorado. But since early 2002, it has been reported in other areas, including Wisconsin, South Dakota, and the Canadian province of Saskatchewan. Indeed, the occurrence of CWD in states that were not endemic previously increased concern about a widespread outbreak and possible transmission to people and cattle.

To date, experimental studies have proven that the CWD agent can be transmitted to cattle by intracerebral inoculation and that it can cross the mucous membranes of the digestive tract to initiate infection in lymphoid tissue before invasion of the central nervous system. Yet the plausibility of CWD spreading to people has remained elusive.

Part of the problem seems to stem from the US surveillance system. CJD is only reported in those areas known to be endemic foci of CWD. Moreover, US authorities have been criticised for not having performed enough prionic tests in farm deer and elk.

Although in November last year the US Food and Drug Administration issued a directive to state public-health and agriculture officials prohibiting material from CWD-positive animals from being used as an ingredient in feed for any animal species, epidemiological control and research in the USA has been quite different from the situation in the UK and Europe regarding BSE.

"Getting data on TSEs in the USA from the government is like pulling teeth", Singeltary argues. "You get it when they want you to have it, and only what they want you to have."

Norman Foster, director of the Cognitive Disorders Clinic at the University of Michigan (Ann Arbor, MI, USA), says that "current surveillance of prion disease in people in the USA is inadequate to detect whether CWD is occurring in human beings"; adding that, "the cases that we know about are reassuring, because they do not suggest the appearance of a new variant of CJD in the USA or atypical features in patients that might be exposed to CWD. However, until we establish a system that identifies and analyses a high proportion of suspected prion disease cases we will not know for sure". The USA should develop a system modelled on that established in the UK, he points out.

Ali Samii, a neurologist at Seattle VA Medical Center who recently reported the cases of three hunters "two of whom were friends" who died from pathologically confirmed CJD, says that "at present there are insufficient data to claim transmission of CWD into humans"; adding that "[only] by asking [the questions of venison consumption and deer/elk hunting] in every case can we collect suspect cases and look into the plausibility of transmission further". Samii argues that by making both doctors and hunters more aware of the possibility of prions spreading through eating venison, doctors treating hunters with dementia can consider a possible prion disease, and doctors treating CJD patients will know to ask whether they ate venison.

CDC spokesman Ermias Belay says that the CDC "will not be investigating the [Samii] cases because there is no evidence that the men ate CWD-infected meat". He notes that although "the likelihood of CWD jumping the species barrier to infect humans cannot be ruled out 100%" and that "[we] cannot be 100% sure that CWD does not exist in humans& the data seeking evidence of CWD transmission to humans have been very limited". 




26 March 2003 

Terry S. Singeltary, retired (medically) CJD WATCH 

I lost my mother to hvCJD (Heidenhain Variant CJD). I would like to comment on the CDC's attempts to monitor the occurrence of emerging forms of CJD. Asante, Collinge et al [1] have reported that BSE transmission to the 129-methionine genotype can lead to an alternate phenotype that is indistinguishable from type 2 PrPSc, the commonest sporadic CJD. However, CJD and all human TSEs are not reportable nationally. CJD and all human TSEs must be made reportable in every state and internationally. I hope that the CDC does not continue to expect us to still believe that the 85%+ of all CJD cases which are sporadic are all spontaneous, without route/source. We have many TSEs in the USA in both animal and man. CWD in deer/elk is spreading rapidly and CWD does transmit to mink, ferret, cattle, and squirrel monkey by intracerebral inoculation. With the known incubation periods in other TSEs, oral transmission studies of CWD may take much longer. Every victim/family of CJD/TSEs should be asked about route and source of this agent. To prolong this will only spread the agent and needlessly expose others. In light of the findings of Asante and Collinge et al, there should be drastic measures to safeguard the medical and surgical arena from sporadic CJDs and all human TSEs. I only ponder how many sporadic CJDs in the USA are type 2 PrPSc? 



2 January 2000 British Medical Journal U.S. 

Scientist should be concerned with a CJD epidemic in the U.S., as well 



15 November 1999 British Medical Journal hvCJD in the USA * BSE in U.S. 



Terry S. Singeltary Sr.