Thursday, February 25, 2016

U.S. Food & Drug Administration (FDA) FDA/CFSAN Cosmetics Update: Cosmetics Program; Import and Domestic and Transmissible Spongiform Encephalopathy TSE Prion Disease Risk Factors

***WARNING TO ALL CONSUMERS AND COUNTRIES AROUND THE WORLD***

 

***Note: FDA labs do not conduct BSE analysis and thus no sampling guidance is issued for BSE. ***

 

*** The basis for any regulatory action on a cosmetic product with respect to prohibited cattle material relies on review of records as described above, labeling and other documentation.***

 

U.S. Food & Drug Administration (FDA) FDA/CFSAN Cosmetics News Update: Cosmetics Program; Import and Domestic and Transmissible Spongiform Encephalopathy TSE Prion Disease Risk Factors

 

snip...

 

3. Prohibited Cattle Material(Coverage of Bovine Tissue and Tissue-Derived Ingredients for Bovine Spongiform Encephalopathy (BSE)

 

(DOMESTICS AND IMPORTS)

 

Bovine Spongiform Encephalopathy (BSE), commonly known as mad-cow disease, is a fatal disease in cattle. The infectious agent has been linked to Cruetzfeldt-Jakob disease, a neurological disorder in humans.BSE is thought to be transmitted from infected cattle to humans via exposure to certain bovine tissues.

 

The cosmetic industry has historically been a user of bovine-derived raw materials. Human exposure to the infectious agent can occur through eye, mouth, or skin. Cosmetics containing infected bovine-derived materials may act as a vehicle capable of transmitting the infection to humans.

 

The agency has determined that certain raw materials from cattle are potentially highly infectious, and, if obtained from infected animals, may contain the BSE infectious agent. Cattle tissues prohibited from use in cosmetics are listed in 21 CFR 700.27, and include:

 

• The small intestine of all cattle except as provided in 21 CFR 700.27 (b) (2)

 

• material from non-ambulatory disabled cattle

 

• material from cattle not inspected and passed

 

• mechanically separated (MS) (Beef)

 

• “specified risk materials” identified in 21 CFR 700.27 (a) (5):

 

o brain

 

o skull

 

o eyes

 

o trigeminal ganglia

 

o spinal cord

 

o vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum)

 

o dorsal root ganglia of cattle 30 months and older

 

o tonsils and distal ileum of the small intestine of all cattle

 

Refer to 21 CFR 700.27 for more information, particularly for more information on the definition for cattle “inspected and passed” and a process for foreign countries to be exempted from provisions regarding prohibited cattle material. A current listing of countries designated for exemption under paragraph (e) of 21 CFR 700.27 may be obtained from CFSAN OFS (Jeffrey Hamer (240)402-4188, or Jeffrey.Hamer@fda.hhs.gov).

 

BSE Record Keeping Requirements:

 

In accordance with 21 CFR 700.27(c), manufacturers and processors of a cosmetic that is manufactured from, processed with, or otherwise contains, material from cattle must establish and maintain records to demonstrate that the cosmetic is not manufactured from, processed with, or does not otherwise contain, prohibited cattle materials.

 

COSMETICS PROGRAM 7329.001

 

TRANSMITTAL NO: 2016-CPGM-CFSAN-001 PART III PAGE 4

 

FORM 2438 g (10/91)

 

These records must be retained for 2 years at the manufacturing establishment or at a reasonably accessible location. Electronic records are acceptable if they are accessible from an onsite location.

 

These records must be available to FDA for inspection and copying.

 

Product labels and cosmetic raw materials, bulk cosmetic formulations, and finished cosmetic products and relevant records should be reviewed to determine if any of the products or ingredients contain prohibited cattle material.

 

If a firm manufacturing or importing cosmetic products or their ingredients uses any prohibited cattle material, document the following:

 

• The finished products containing the prohibited tissue

 

• The specific country of origin of the tissue

 

• The name and address of the importer or other responsible party.

 

The district compliance branch should consult with the CFSAN/OC/DE/Labeling and Dietary Supplements Compliance Branch (LDSCB) (HFS-608) for regulatory consideration.

 

Attachment B “Bovine Tissue and Tissue-Derived Ingredients, Materials with Suspected Risk of Infectivity” lists high-risk tissues to assist investigators in the identification of tissues and tissue-derived ingredients of concern. If a firm manufacturing or importing cosmetic products or their ingredients uses a tissue or tissue-derived ingredient listed in Attachment B but not otherwise listed as prohibited cattle material in 21 CFR 700.27, the FDA investigator should determine whether it has been exported from and/or originated from a BSE affected or at-risk country. If so, the investigator should contact CFSAN for further guidance.

 

A current list of BSE affected or at-risk countries can be found at: USDA’s Animal and Plant Health Inspection Service (APHIS) website (https://www.aphis.usda.gov/wps/portal/aphis/home/). Search “countries/regions affected by BSE.”

 

Note: FDA labs do not conduct BSE analysis and thus no sampling guidance is issued for BSE. The basis for any regulatory action on a cosmetic product with respect to prohibited cattle material relies on review of records as described above, labeling and other documentation.

 

4. Adequacy of Preservation (DOMESTICS)

 

snip...

 


 

Tuesday, March 5, 2013

 

Use of Materials Derived From Cattle in Human Food and Cosmetics; Reopening of the Comment Period FDA-2004-N-0188-0051 (TSS SUBMISSION)

 

FDA believes current regulation protects the public from BSE but reopens comment period due to new studies

 


 

Monday, February 01, 2010

 

Import Alert 17-04 BSE CJD HIGH RISK TISSUES, Nutritional Supplements and Cosmetics Import Alert 17-04

 


 

-------- Original Message -------- Subject: Medical Product Certified Herd Use For Bovine-Derived Source Materials Proposed By FDA Date: Wed, 11 Feb 2004 15:17:32 -0600 From: "Terry S. Singeltary Sr." flounder@wt.net Reply-To: Bovine Spongiform Encephalopathy BSE-L@uni-karlsruhe.de To: BSE-L@uni-karlsruhe.de

 


 

Thursday, January 14, 2016

 

*** EMERGING ANIMAL DISEASES Actions Needed to Better Position USDA to Address Future Risks Report to the Chairman, Committee on Energy and Commerce, House of Representatives December 2015 GAO-16-132

 

GAO

 


 

 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.

 

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

 

PRION 2015 CONFERENCE FT. COLLINS CWD RISK FACTORS TO HUMANS

 

*** LATE-BREAKING ABSTRACTS PRION 2015 CONFERENCE ***

 

O18

 

Zoonotic Potential of CWD Prions

 

Liuting Qing1, Ignazio Cali1,2, Jue Yuan1, Shenghai Huang3, Diane Kofskey1, Pierluigi Gambetti1, Wenquan Zou1, Qingzhong Kong1 1Case Western Reserve University, Cleveland, Ohio, USA, 2Second University of Naples, Naples, Italy, 3Encore Health Resources, Houston, Texas, USA

 

*** These results indicate that the CWD prion has the potential to infect human CNS and peripheral lymphoid tissues and that there might be asymptomatic human carriers of CWD infection.

 

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

 

***These results indicate that the CWD prion has the potential to infect human CNS and peripheral lymphoid tissues and that there might be asymptomatic human carriers of CWD infection.***

 

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

 

P.105: RT-QuIC models trans-species prion transmission

 

Kristen Davenport, Davin Henderson, Candace Mathiason, and Edward Hoover Prion Research Center; Colorado State University; Fort Collins, CO USA

 

Conversely, FSE maintained sufficient BSE characteristics to more efficiently convert bovine rPrP than feline rPrP. Additionally, human rPrP was competent for conversion by CWD and fCWD.

 

***This insinuates that, at the level of protein:protein interactions, the barrier preventing transmission of CWD to humans is less robust than previously estimated.

 

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

 

***This insinuates that, at the level of protein:protein interactions, the barrier preventing transmission of CWD to humans is less robust than previously estimated.***

 

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

 


 

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

 


 

*** The potential impact of prion diseases on human health was greatly magnified by the recognition that interspecies transfer of BSE to humans by beef ingestion resulted in vCJD. While changes in animal feed constituents and slaughter practices appear to have curtailed vCJD, there is concern that CWD of free-ranging deer and elk in the U.S. might also cross the species barrier. Thus, consuming venison could be a source of human prion disease. Whether BSE and CWD represent interspecies scrapie transfer or are newly arisen prion diseases is unknown. Therefore, the possibility of transmission of prion disease through other food animals cannot be ruled out. There is evidence that vCJD can be transmitted through blood transfusion. There is likely a pool of unknown size of asymptomatic individuals infected with vCJD, and there may be asymptomatic individuals infected with the CWD equivalent. These circumstances represent a potential threat to blood, blood products, and plasma supplies.

 


 

now, let’s see what the authors said about this casual link, personal communications years ago. see where it is stated NO STRONG evidence. so, does this mean there IS casual evidence ???? “Our conclusion stating that we found no strong evidence of CWD transmission to humans”

 

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

 

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

 

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

 

From: "Belay, Ermias"

 

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

 

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

 

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

 

Dear Sir/Madam,

 

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

 

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

 

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

 

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

 

To: rr26k@nih.gov; rrace@niaid.nih.gov; ebb8@CDC.GOV

 

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

 

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

 

Thursday, April 03, 2008

 

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

 

snip...

 

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

 

snip... full text ;

 


 

CJD is so rare in people under age 30, one case in a billion (leaving out medical mishaps), that four cases under 30 is "very high," says Colorado neurologist Bosque. "Then, if you add these other two from Wisconsin [cases in the newspaper], six cases of CJD in people associated with venison is very, very high." Only now, with Mary Riley, there are at least seven, and possibly eight, with Steve, her dining companion. "It's not critical mass that matters," however, Belay says. "One case would do it for me." The chance that two people who know each other would both contact CJD, like the two Wisconsin sportsmen, is so unlikely, experts say, it would happen only once in 140 years.

 

Given the incubation period for TSEs in humans, it may require another generation to write the final chapter on CWD in Wisconsin. "Does chronic wasting disease pass into humans? We'll be able to answer that in 2022," says Race. Meanwhile, the state has become part of an immense experiment.

 


 

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

 

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

 


 

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

 


 

***This information will have a scientific impact since it is the first study that demonstrates the transmission of scrapie to a non-human primate with a close genetic relationship to humans. This information is especially useful to regulatory officials and those involved with risk assessment of the potential transmission of animal prion diseases to humans.

 

***This observation strengthens the questioning of the harmlessness of scrapie to humans, at a time when protective measures for human and animal health are being dismantled and reduced as c-BSE is considered controlled and being eradicated. Our results underscore the importance of precautionary and protective measures and the necessity for long-term experimental transmission studies to assess the zoonotic potential of other animal prion strains.

 


 

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

 

Title: Evaluation of the zoonotic potential of transmissible mink encephalopathy

 

Authors

 

item Comoy, Emmanuel - item Mikol, Jacqueline - item Ruchoux, Marie-Madeleine - item Durand, Valerie - item Luccantoni-Freire, Sophie - item Dehen, Capucine - item Correia, Evelyne - item Casalone, Cristina - item Richt, Juergen item Greenlee, Justin item Torres, Juan Maria - item Brown, Paul - item Deslys, Jean-Philippe -

 

Submitted to: Pathogens Publication Type: Peer Reviewed Journal Publication Acceptance Date: July 30, 2013 Publication Date: July 30, 2013 Citation: Comoy, E.E., Mikol, J., Ruchoux, M., Durand, V., Luccantoni-Freire, S., Dehen, C., Correia, E., Casalone, C., Richt, J.A., Greenlee, J.J., Torres, J.M., Brown, P., Deslys, J. 2013. Evaluation of the zoonotic potential of transmissible mink encephalopathy. Pathogens. 2:(3)520-532.

 

Interpretive Summary: Cases of bovine spongiform encephalopathy (BSE) or mad cow disease can be subclassified into at least 3 distinct disease forms with the predominate form known as classical BSE and the others collectively referred to as atypical BSE. Atypical BSE can be further subdivided into H-type and L-type cases that are distinct from classical BSE and from each other. Both of the atypical BSE subtypes are believed to occur spontaneously, whereas classical BSE is spread through feeding contaminated meat and bone meal to cattle. Transmissible mink encephalopathy (TME) is another prion disease that transmits to cattle and show similarities to L-type BSE when subjected to laboratory testing. The purpose of this study was to use non-human primates (cynomologous macaque) and transgenic mice expressing the human prion protein to determine if TME could represent a potential risk to human health. TME from two sources (cattle and raccoons) was able to infect non-human primates and transgenic mice after exposure by the intracranial route. This result suggest that humans may be able to replicate TME prions after an exposure that allows infectious material access to brain tissue. At this time, it is unknown whether non-human primates or transgenic mice would be susceptible to TME prions after oral exposure. The results obtained in these animal models were similar to those obtained for L-type BSE. Although rare, the existence of TME and that it transmits to cattle, non-human primates, and transgenic mice suggest that feed bans preventing the feeding of mammalian tissues to cattle should stay in place and that regular prion surveillance during the slaughter should remain in place. Parties with interest in the cattle and beef industries and regulatory officials responsible for safe feeding practices of cattle will be interested in this work. Technical Abstract: Successful transmission of Transmissible Mink Encephalopathy (TME) to cattle supports the bovine hypothesis to the still controversial origin of TME outbreaks. Human and primate susceptibility to classical Bovine Spongiform Encephalopathy (c-BSE) and the transmissibility of L-type BSE to macaques assume a low cattle-to-primate species barrier: we therefore evaluated the zoonotic potential of cattle-adapted TME. In less than two years, this strain induced in cynomolgus macaques a neurological disease similar to L-BSE and distinct from c-BSE. TME derived from another donor species (raccoon) induced a similar disease with shorter incubation periods.

 

*** L-BSE and cattle-adapted TME were also transmissible to transgenic mice expressing human PrP. Interestingly, secondary transmissions to transgenic mice expressing bovine PrP showed the maintenance of prion strain features for the three tested bovine prion strains (cattle TME, c-BSE and L-BSE) regardless of intermediate host.

 

*** Thus, TME is the third animal prion strain transmissible to both macaques and humanized transgenic mice, suggesting zoonotic potentials that should be considered in the risk analysis of animal prion diseases for human health.

 

*** Moreover, the similarities between TME and L-BSE are highly suggestive of a link between those strains, and of the presence of L-BSE decades prior to its identification in USA and Europe.

 


 

Evidence That Transmissible Mink Encephalopathy Results from Feeding Infected Cattle

 

Over the next 8-10 weeks, approximately 40% of all the adult mink on the farm died from TME.

 

snip...

 

The rancher was a ''dead stock'' feeder using mostly (>95%) downer or dead dairy cattle...

 


 


 


 

Friday, December 14, 2012

 

DEFRA U.K. What is the risk of Chronic Wasting Disease CWD being introduced into Great Britain? A Qualitative Risk Assessment October 2012

 

snip...

 

In the USA, under the Food and Drug Administration’s BSE Feed Regulation (21 CFR 589.2000) most material (exceptions include milk, tallow, and gelatin) from deer and elk is prohibited for use in feed for ruminant animals. With regards to feed for non-ruminant animals, under FDA law, CWD positive deer may not be used for any animal feed or feed ingredients. For elk and deer considered at high risk for CWD, the FDA recommends that these animals do not enter the animal feed system. However, this recommendation is guidance and not a requirement by law.

 

Animals considered at high risk for CWD include:

 

1) animals from areas declared to be endemic for CWD and/or to be CWD eradication zones and

 

2) deer and elk that at some time during the 60-month period prior to slaughter were in a captive herd that contained a CWD-positive animal.

 

Therefore, in the USA, materials from cervids other than CWD positive animals may be used in animal feed and feed ingredients for non-ruminants.

 

The amount of animal PAP that is of deer and/or elk origin imported from the USA to GB can not be determined, however, as it is not specified in TRACES. It may constitute a small percentage of the 8412 kilos of non-fish origin processed animal proteins that were imported from US into GB in 2011.

 

Overall, therefore, it is considered there is a __greater than negligible risk___ that (nonruminant) animal feed and pet food containing deer and/or elk protein is imported into GB.

 

There is uncertainty associated with this estimate given the lack of data on the amount of deer and/or elk protein possibly being imported in these products.

 

snip...

 

36% in 2007 (Almberg et al., 2011). In such areas, population declines of deer of up to 30 to 50% have been observed (Almberg et al., 2011). In areas of Colorado, the prevalence can be as high as 30% (EFSA, 2011). The clinical signs of CWD in affected adults are weight loss and behavioural changes that can span weeks or months (Williams, 2005). In addition, signs might include excessive salivation, behavioural alterations including a fixed stare and changes in interaction with other animals in the herd, and an altered stance (Williams, 2005). These signs are indistinguishable from cervids experimentally infected with bovine spongiform encephalopathy (BSE). Given this, if CWD was to be introduced into countries with BSE such as GB, for example, infected deer populations would need to be tested to differentiate if they were infected with CWD or BSE to minimise the risk of BSE entering the human food-chain via affected venison.

 

snip...

 

The rate of transmission of CWD has been reported to be as high as 30% and can approach 100% among captive animals in endemic areas (Safar et al., 2008).

 

snip...

 

In summary, in endemic areas, there is a medium probability that the soil and surrounding environment is contaminated with CWD prions and in a bioavailable form. In rural areas where CWD has not been reported and deer are present, there is a greater than negligible risk the soil is contaminated with CWD prion.

 

snip...

 

In summary, given the volume of tourists, hunters and servicemen moving between GB and North America, the probability of at least one person travelling to/from a CWD affected area and, in doing so, contaminating their clothing, footwear and/or equipment prior to arriving in GB is greater than negligible. For deer hunters, specifically, the risk is likely to be greater given the increased contact with deer and their environment. However, there is significant uncertainty associated with these estimates.

 

snip...

 

Therefore, it is considered that farmed and park deer may have a higher probability of exposure to CWD transferred to the environment than wild deer given the restricted habitat range and higher frequency of contact with tourists and returning GB residents.

 

snip...

 


 

THIRD, THE USDA FDA TRIPLE MAD COW DISEASE FIREWALL, WAS NOTHING MORE THAN INK ON PAPER !

 

now, let’s just for a moment put away the corporate junk science, and let’s look at recent updated BSE, CWD, Scrapie, TSE Prion sound science, could not hurt...

 

Saturday, January 31, 2015

 

European red deer (Cervus elaphus elaphus) are susceptible to Bovine Spongiform Encephalopathy BSE by Oral Alimentary route

 


 

I strenuously once again urge the FDA and its industry constituents, to make it MANDATORY that all ruminant feed be banned to all ruminants, and this should include all cervids as soon as possible for the following reasons...

 

======

 

In the USA, under the Food and Drug Administrations BSE Feed Regulation (21 CFR 589.2000) most material (exceptions include milk, tallow, and gelatin) from deer and elk is prohibited for use in feed for ruminant animals. With regards to feed for non-ruminant animals, under FDA law, CWD positive deer may not be used for any animal feed or feed ingredients. For elk and deer considered at high risk for CWD, the FDA recommends that these animals do not enter the animal feed system.

 

***However, this recommendation is guidance and not a requirement by law.

 

======

 

31 Jan 2015 at 20:14 GMT

 

*** Ruminant feed ban for cervids in the United States? ***

 

31 Jan 2015 at 20:14 GMT

 

see Singeltary comment ;

 


 

Oral transmission and early lymphoid tropism of chronic wasting disease PrPres in mule deer fawns (Odocoileus hemionus )

 

These results indicate that CWD PrP res can be detected in lymphoid tissues draining the alimentary tract within a few weeks after oral exposure to infectious prions and may reflect the initial pathway of CWD infection in deer. The rapid infection of deer fawns following exposure by the most plausible natural route is consistent with the efficient horizontal transmission of CWD in nature and enables accelerated studies of transmission and pathogenesis in the native species.

 

snip...

 

These results indicate that mule deer fawns develop detectable PrP res after oral exposure to an inoculum containing CWD prions. In the earliest post-exposure period, CWD PrPres was traced to the lymphoid tissues draining the oral and intestinal mucosa (i.e. the retropharyngeal lymph nodes, tonsil, ileal Peyer's patches and ileocaecal lymph nodes), which probably received the highest initial exposure to the inoculum. Hadlow et al. (1982) demonstrated scrapie agent in the tonsil, retropharyngeal and mesenteric lymph nodes, ileum and spleen in a 10-month-old naturally infected lamb by mouse bioassay. Eight of nine sheep had infectivity in the retropharyngeal lymph node. He concluded that the tissue distribution suggested primary infection via the gastrointestinal tract. The tissue distribution of PrPres in the early stages of infection in the fawns is strikingly similar to that seen in naturally infected sheep with scrapie. These findings support oral exposure as a natural route of CWD infection in deer and support oral inoculation as a reasonable exposure route for experimental studies of CWD.

 

snip...

 


 

Title: Experimental oral transmission of chronic wasting disease (CWD) to red deer (Cervus elaphus elaphus): early detection and late stage distribution of protease-resistant protein (PrP-res)

 

In this study, red deer (Cervus elaphus elaphus) were exposed to the prion agent by oral administration of brain homogenates from infected Rocky Mountain elk. Antemortem testing was performed at 7 months post infection and the deer were euthanized when clinical disease was observed at approximately 18 months after infection. The abnormal prion protein was assayed by immunohistochemistry, enzyme linked immunosorbent assay and western blot. Abnormal prion protein was found in the spinal cord, brainstem, cerebellum, midbrain, thalamus, and cerebrum in all 4 infected red deer. Most of the lymph nodes throughout the body were positive for abnormal prion proteins. Abnromal prion protein was observed in some additional peripheral tissues in some but not all of the deer. In particular, most areas of the gastrointestinal tract were positive for abnormal prions, although the salivary glands were rarely positive. This study demonstrates the potential for oral transmission of chronic wasting disease to red deer and confirms the usefulness of the current testing methods for post mortem diagnosis of the disease in this species.

 


 

Sunday, April 5, 2015

 

*** Guidance for Industry Ensuring Safety of Animal Feed Maintained and Fed On-Farm Draft Guidance FDA-2014-D-1180 ***

 


 

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

 


 

*** It also suggests a similar cause or source for atypical BSE in these countries. ***

 

Discussion: The C, L and H type BSE cases in Canada exhibit molecular characteristics similar to those described for classical and atypical BSE cases from Europe and Japan.

 

*** This supports the theory that the importation of BSE contaminated feedstuff is the source of C-type BSE in Canada.

 

*** It also suggests a similar cause or source for atypical BSE in these countries. ***

 

see page 176 of 201 pages...tss

 


 

***atypical spontaneous BSE in France LOL***

 

FRANCE STOPS TESTING FOR MAD COW DISEASE BSE, and here’s why, to many spontaneous events of mad cow disease $$$

 

***so 20 cases of atypical BSE in France, compared to the remaining 40 cases in the remaining 12 Countries, divided by the remaining 12 Countries, about 3+ cases per country, besides Frances 20 cases. you cannot explain this away with any spontaneous BSe. ...TSS

 

Sunday, October 5, 2014

 

France stops BSE testing for Mad Cow Disease

 


 

10 years post mad cow feed ban August 1997

 

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

 

Date: March 21, 2007 at 2:27 pm PST

 

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINES -- CLASS II

 

PRODUCT

 

Bulk cattle feed made with recalled Darling's 85% Blood Meal, Flash Dried, Recall # V-024-2007

 

CODE

 

Cattle feed delivered between 01/12/2007 and 01/26/2007

 

RECALLING FIRM/MANUFACTURER

 

Pfeiffer, Arno, Inc, Greenbush, WI. by conversation on February 5, 2007.

 

Firm initiated recall is ongoing.

 

REASON

 

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

 

VOLUME OF PRODUCT IN COMMERCE

 

42,090 lbs.

 

DISTRIBUTION

 

WI

 

___________________________________

 

PRODUCT

 

Custom dairy premix products: MNM ALL PURPOSE Pellet, HILLSIDE/CDL Prot- Buffer Meal, LEE, M.-CLOSE UP PX Pellet, HIGH DESERT/ GHC LACT Meal, TATARKA, M CUST PROT Meal, SUNRIDGE/CDL PROTEIN Blend, LOURENZO, K PVM DAIRY Meal, DOUBLE B DAIRY/GHC LAC Mineral, WEST PIONT/GHC CLOSEUP Mineral, WEST POINT/GHC LACT Meal, JENKS, J/COMPASS PROTEIN Meal, COPPINI - 8# SPECIAL DAIRY Mix, GULICK, L-LACT Meal (Bulk), TRIPLE J - PROTEIN/LACTATION, ROCK CREEK/GHC MILK Mineral, BETTENCOURT/GHC S.SIDE MK-MN, BETTENCOURT #1/GHC MILK MINR, V&C DAIRY/GHC LACT Meal, VEENSTRA, F/GHC LACT Meal, SMUTNY, A- BYPASS ML W/SMARTA, Recall # V-025-2007

 

CODE

 

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

 

RECALLING FIRM/MANUFACTURER

 

Rangen, Inc, Buhl, ID, by letters on February 13 and 14, 2007. Firm initiated recall is complete.

 

REASON

 

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

 

VOLUME OF PRODUCT IN COMMERCE

 

9,997,976 lbs.

 

DISTRIBUTION

 

ID and NV

 

END OF ENFORCEMENT REPORT FOR MARCH 21, 2007

 


 

16 years post mad cow feed ban August 1997

 

2013

 

Sunday, December 15, 2013

 

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

 


 

17 years post mad cow feed ban August 1997

 

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

 


 

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, February 16, 2016

 

Real and perceived issues involving animal proteins C. R. Hamilton May 3, 2002, a review of USDA MAD COW DISEASE BSE FEED AND CERVID 2016

 


 

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

 

Title: Transmission of scrapie prions to primate after an extended silent incubation period

 

Authors

 

item Comoy, Emmanuel - item Mikol, Jacqueline - item Luccantoni-Freire, Sophie - item Correia, Evelyne - item Lescoutra-Etchegaray, Nathalie - item Durand, Valérie - item Dehen, Capucine - item Andreoletti, Olivier - item Casalone, Cristina - item Richt, Juergen item Greenlee, Justin item Baron, Thierry - item Benestad, Sylvie - item Hills, Bob - item Brown, Paul - item Deslys, Jean-Philippe -

 

Submitted to: Scientific Reports Publication Type: Peer Reviewed Journal Publication Acceptance Date: May 28, 2015 Publication Date: June 30, 2015 Citation: Comoy, E.E., Mikol, J., Luccantoni-Freire, S., Correia, E., Lescoutra-Etchegaray, N., Durand, V., Dehen, C., Andreoletti, O., Casalone, C., Richt, J.A., Greenlee, J.J., Baron, T., Benestad, S., Brown, P., Deslys, J. 2015. Transmission of scrapie prions to primate after an extended silent incubation period. Scientific Reports. 5:11573.

 

Interpretive Summary:

 

The transmissible spongiform encephalopathies (also called prion diseases) are fatal neurodegenerative diseases that affect animals and humans. The agent of prion diseases is a misfolded form of the prion protein that is resistant to breakdown by the host cells. Since all mammals express prion protein on the surface of various cells such as neurons, all mammals are, in theory, capable of replicating prion diseases. One example of a prion disease, bovine spongiform encephalopathy (BSE; also called mad cow disease), has been shown to infect cattle, sheep, exotic undulates, cats, non-human primates, and humans when the new host is exposed to feeds or foods contaminated with the disease agent.

 

***The purpose of this study was to test whether non-human primates (cynomologous macaque) are susceptible to the agent of sheep scrapie.

 

***After an incubation period of approximately 10 years a macaque developed progressive clinical signs suggestive of neurologic disease.

 

***Upon postmortem examination and microscopic examination of tissues, there was a widespread distribution of lesions consistent with a transmissible spongiform encephalopathy.

 

This information will have a scientific impact since it is the first study that demonstrates the transmission of scrapie to a non-human primate with a close genetic relationship to humans. This information is especially useful to regulatory officials and those involved with risk assessment of the potential transmission of animal prion diseases to humans.

 

Technical Abstract:

 

Classical bovine spongiform encephalopathy (c-BSE) is an animal prion disease that also causes variant Creutzfeldt-Jakob disease in humans. Over the past decades, c-BSE's zoonotic potential has been the driving force in establishing extensive protective measures for animal and human health. In complement to the recent demonstration that humanized mice are susceptible to scrapie, we report here the first observation of direct transmission of a natural classical scrapie isolate to a macaque after a 10-year incubation period. Neuropathologic examination revealed all of the features of a prion disease: spongiform change, neuronal loss, and accumulation of PrPres throughout the CNS.

 

***This observation strengthens the questioning of the harmlessness of scrapie to humans, at a time when protective measures for human and animal health are being dismantled and reduced as c-BSE is considered controlled and being eradicated. Our results underscore the importance of precautionary and protective measures and the necessity for long-term experimental transmission studies to assess the zoonotic potential of other animal prion strains.

 


 

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 amplification (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.

 

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

 


 


 

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

 

***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.

 

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

 

*** Needless conflict ***

 

Nature 485, 279–280 (17 May 2012) doi:10.1038/485279b

 

Published online 16 May 2012

 

Terry S. Singeltary Sr. said:

 

I kindly wish to submit the following please ;

 


 

Comments on technical aspects of the risk assessment were then submitted to FSIS.

 

Comments were received from Food and Water Watch, Food Animal Concerns Trust (FACT), Farm Sanctuary, R-CALF USA, Linda A Detwiler, and Terry S. Singeltary.

 

This document provides itemized replies to the public comments received on the 2005 updated Harvard BSE risk assessment. Please bear the following points in mind:

 


 

Owens, Julie

 

From: Terry S. Singeltary Sr. [flounder9@verizon.net]

 

Sent: Monday, July 24, 2006 1:09 PM

 

To: FSIS RegulationsComments

 

Subject: [Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine Spongiform Encephalopathy (BSE)

 

Page 1 of 98

 


 

FSIS, USDA, REPLY TO SINGELTARY

 


 

Singeltary to APHIS FDA USDA et al ;

 


 


 

Current CDER Approaches to Minimizing the Risk of TSE Agents in Drugs (HTM) (PDF) (Word)

 

CDER Current Recommendations on Measures to Minimize Risk of TSE Agents in Medical Devices (HTM) (PDF) (Word)

 

Memorandum Regarding TSE/BSE Letter to Manufacturers of FDA-Regulated Medical Devices Containing Animal Tissue Products or Components (PDF)

 

Impact on FDA-Regulated Foods, Including Dietary Supplements, and Cosmetics (HTM) (PDF) (Word)

 

Food and Drug Administration Transmissible Spongiform Encephalopathies Advisory Committee

 

February 12, 2004

 

Issue Summary for Topic #4 F, Update on the Washington State BSE Case

 

Issue: Impact on FDA-regulated Foods, including Dietary Supplements, and Cosmetics

 

Background:

 

FDA has jurisdiction over most food products, including those that contain a relatively small proportion of meat (exempted under the Federal Meat Inspection Act). Many of the foods, including dietary supplements, food additives, and food ingredients, and cosmetics regulated by FDA contain beef or components of beef. Examples of the bovine-origin products regulated by FDA are soups and stocks, beef flavors and extracts, gelatin, collagen, amino acids, and foods that contain small amounts of beef, such as pizza, multi-component frozen meals, and entrees. Many cosmetics contain tallow or tallow derivatives, gelatin, collagen, and other bovine components. Dietary supplements are often enclosed in gelatin capsules and may be composed of a variety of bovine tissues. Foods, including dietary supplements, food additives, and food ingredients may be formulated from any ingredient that is safe and wholesome, unless specifically prohibited by regulation. Since 1992, the agency has strongly recommended that firms manufacturing or importing foods that might contain bovine tissues, including extracts or substances derived from these tissues, take whatever steps are necessary to reduce the potential risk of human exposure to or transmission of the infectious agent that causes BSE. Since 1992, FDA has advised dietary supplement manufacturers and distributors that they should take steps to ensure that no dietary supplement ingredients come from cattle born, raised or slaughtered in any country known to have BSE or that has inadequate controls to detect and control it. Except for color additives and those ingredients prohibited or restricted by regulation, a manufacturer may essentially use any ingredient in the formulation of a cosmetic product provided the product is safe, properly labeled, and not adulterated by use of the ingredient. As is true for foods, including dietary supplements, since 1994, we have strongly recommended that firms manufacturing or importing cosmetic products that contain bovine tissues, including extracts or substances derived from these tissues, take whatever steps are necessary to reduce the potential risk of human exposure to or transmission of the infectious agent that causes BSE. Gelatin produced from bovine hides and bones is used in foods, including dietary supplements, cosmetics, and many other FDA-regulated products. In 1997, to reduce the risk of BSE transmission, the agency published guidance on production of gelatin for oral consumption that recommended removal of the skull, spine and spinal cord and made recommendations on sourcing of bones and hides. During the July 2003 TSEAC meeting, evidence on the effectiveness of gelatin processing was presented to the committee. We are considering the need to revise the guidance in view of the pending issuance of the BSE regulation recently announced by FDA. If the gelatin guidance is still necessary, we will revise it taking into consideration the committee s comments and the provisions of the regulation. The agency also recently received a petition to modify the guidance. If the gelatin guidance is revised, it will be presented at a TSEAC meeting later in 2004. The identification of the first case of BSE in the United States., even though the animal was imported from Canada, triggered emergency response reactions by USDA and FDA to retrieve products of the slaughter that went to edible and inedible rendering. USDA published regulations that prohibit the inclusion in human food of downer cattle, SRMs from cattle 30 months of age or older, and the product Mechanically Separated Beef, and established new standards for Advanced Meat Recovery meat to limit central nervous system tissue in the product. The general flow of bovine-origin materials into FDA-regulated foods, dietary supplements, and cosmetics influences the degree of BSE risk to consumers in the United States, and is under agency review.

 

CURRENT On January 26, 2004, FDA announced that it intends to publish a regulation that bans in human foods, including dietary supplements, and cosmetics: · Use of non-ambulatory disabled animals and animals that die before being presented for slaughter · Specified Risk Materials, · Mechanically Separated (Beef), and · Tissue from animals that are inspected and not passed for human consumption This will be an interim final regulation, open to public comment, that essentially parallels actions taken by USDA in their interim final rules published January 12, 2004.

 


 


 

Subject: BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001

 

Date: Tue, 9 Jan 2001 16:49:00 –0800

 

From: "Terry S. Singeltary Sr."

 

Reply-To: Bovine Spongiform Encephalopathy BSE-L

 

To: BSE-L

 

snip...

 

[host Richard Barns] and now a question from Terry S. Singeltary of CJD Watch.

 

[TSS] yes, thank you, U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds?

 

[no answer, you could hear in the back ground, mumbling and 'we can't. have him ask the question again.]

 

[host Richard] could you repeat the question?

 

[TSS] U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds?

 

[not sure whom ask this] what group are you with?

 

[TSS] CJD Watch, my Mom died from hvCJD and we are tracking CJD world-wide.

 

[not sure who is speaking] could you please disconnect Mr. Singeltary

 

[TSS] you are not going to answer my question?

 

[not sure whom speaking] NO

 

snip...

 

Subject: BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001

 

Date: Tue, 9 Jan 2001 16:49:00 -0800

 

From: "Terry S. Singeltary Sr."

 

Reply-To: Bovine Spongiform Encephalopathy

 

To: BSE-L@uni-karlsruhe.de

 

######### Bovine Spongiform Encephalopathy #########

 


 

SEE HISTORY ON BSE TSE PRION AND COSMETICS BSE INQUIRY DFA 18

 

89 Thursday, July 22, 2010 BSE INQUIRY DFA 18 COSMETICS From: TSS

 

Subject: Use of Materials Derived From Cattle in Human Food and Cosmetics [Docket No. 2004N-0081] RIN 0910-AF47

 

Date: April 17, 2008 at 2:41 pm PST

 


 


 


 


 

 In experimentally infected cattle, brain and spinal cord were again been confirmed to be infectious, but in addition the distal ileum (lower small intestine) also contained significant amounts of infectivity(31, 32). Two key ganglia, which are key intermediate points linking the central and peripheral nervous systems, namely TAFS 3 the trigeminal and dorsal root ganglia (DRG), were also clearly infectious(32, 33). This is not surprising given their close association with central nervous tissue. Peripheral nerves have also been demonstrated to become positive after the brain and spinal cord(1, 19). Completion of bioassay studies has also enabled a better understanding of the sequence of events, and rate of accumulation of infectivity, especially in relation to ileum, brain and spinal cord(1,2), and have confirmed the basic assumptions upon risk management policy were based.

 

PAGE 3

 


 

 Thursday, April 17, 2008

 

Use of Materials Derived From Cattle in Human Food and Cosmetics [Docket No. 2004N-0081] RIN 0910-AF47 [Federal Register: April 17, 2008 (Volume 73, Number 75)] [Rules and Regulations] [Page 20785-20794] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr17ap08-7]

 


 

 Monday, February 01, 2010

 

Import Alert 17-04 BSE CJD HIGH RISK TISSUES, Nutritional Supplements and Cosmetics

 


 

 SEE HISTORY OF COSMETICS AND MAD COW TYPE DISEASE

 

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

 

Subject: Docket No. 2004N-0081 and or RIN number RIN-0910-AF47 Use of Materials Derived From Cattle in Human Food and Cosmetics [comment submission]

 

Date: Tue, 13 Jul 2004 16:08:38 -0500

 

From: "Terry S. Singeltary Sr." T

 

o: fdadockets@oc.fda.gov

 

CC: burt.pritchett@fda.gov, Agriculture@mail.house.gov

 

COMMENT SUBMISSION [Docket No. 2004N-O081] RIN-0910--AF47 Use of Materials Derived From Cattle in Human Food and Cosmetics

 


 

Greetings FDA,

 

I would kindly like to comment on the potential for TSE transmission from cosmetics to humans and why I think that ALL animal by-products should be excluded from cosmetics. IF we look at the TSE 'KURU'. Kuru is a transmissible spongiform encephalopathy that was identified in Papua New Guinea in the late 1950s. Several thousand cases of the disease occurred during a period of several decades. Epidemiologic investigations implicated ritual endocannibalistic funeral feasts as the likely route through which the infectious agent was spread. The incubation period in females was estimated to be shorter than that in males. The shortest incubation periods were estimated in adult women, who may have been exposed to the largest doses of infectious material. MY question is, was the woman exposed to larger doses, are was it the route of the agent that may have been the factor of shorter incubation in woman, or both?

 

What is Kuru? Kuru is a rare and fatal brain disorder that occurred at epidemic levels during the 1950s-60s among the Fore people in the highlands of New Guinea. The disease was the result of the practice of ritualistic cannibalism among the Fore, in which relatives prepared and consumed the tissues (including brain) of deceased family members. Brain tissue from individuals with kuru was highly infectious, and the disease was transmitted either through eating or by contact with open sores or wounds. Government discouragement of the practice of cannibalism led to a continuing decline in the disease, which has now mostly disappeared.

 

snip...

 

PLEASE NOTE the later ''or by contact with open sores or wounds.''

 

and the disease was transmitted either through eating or by contact with open sores or wounds.

 


 

the Fore women would scoop the brains of their dead relatives out of their skulls by hand before cooking. They then wiped the residual liquid and cadaver tissue over their paint-daubed bodies, leaving it caked in their hair and on their bodies for weeks after a mortuary feast.

 

Jennifer Cooke: kuru deaths continue in 1999

 

Sydney Morning Herald, Saturday, August 28, 1999

 

TSE INFECTION does takes place when the skin surface has been broken by scarification (Taylor et al, 1996).

 

The transmission of KURU into animals supported the belief that the disease had been transmitted through ceremonial cannibalistic rituals in New Guinea with a possible route of spread involving handling fresh tissue and inoculation through mucous membranes and wounds including skin abrasions (Gajdusek, 1977)

 

Masters, C.J., Gajdusek, D.C. and Gibbs, C.J., (1980). The spongiform encephalopathies: the natural history of CJD and its relationship to kuru and scrapie.

 

* Gajdusek D.C. (1996). Kuru: From the New Guinea field journals 1957-1962. Grand Street, 15:6-33

 

* Gajdusek D.C. (1973). Kuru in the New Guinea Highlands. In Spillane JD (ed): Tropical Neurology. New York, Oxford University Press.

 

* Gajdusek D.C., Gibbs C.J., and M. Alpers (1966). Experimental transmission of a kuru-like syndrome to chimpanzees. Nature, 209:794.

 

* Lindenbaum S. (1979). Kuru Sorcery. Mountain View, Ca, Mayfield Publishing Company.

 

SCCNFP/0724/03, final THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS OPINION CONCERNING USE OF SPECIFIED RISK MATERIAL IN COSMETICS CLARIFICATION FOR TALLOW DERIVATIVES adopted by the SCCNFP on 30 July 2003 by means of the written procedure SCCNFP/0724/03, final Opinion on the Use of specified risk material in cosmetics - Clarification for tallow derivatives

 

____________________________________________________________________________ _________________

 

2 1. Background

 

snip...

 


 

 4. For GBR-C III and IV countries, tallow derivatives are safe if, in addition to the above (3), the specific risk materials have been removed and are not used for the production of tallow/tallow derivatives.

 

PLEASE NOTE, under the old BSE GBR, the USA would be re-classified as at least a GBR III risk assessment, if not a GBR IV in my opinion due to the misgivings from USDA/APHIS et al, some documented below in my references from Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW BSE SAFEGUARDS (comment submission).

 

Report on the Assessment of the Geographical BSE - Risk of USA (July 2000) (220kb)

 


 

 snip...end

 

Subject: DFA 18 Cosmetics...[There have been reports of BSE outbreaks in Germany, France, and even in the U.S.A., a prime market for Jersey cattle]

 

From: "Terry S. Singeltary Sr."

 

Reply-To: Bovine Spongiform Encephalopathy

 

Date: Mon, 1 Nov 1999 09:28:04 -0600

 

Content-Type: text/plain

 

Parts/Attachments: text/plain (66 lines)

 

Reply

 

Terry S. Singeltary Sr., Bacliff, Texas USA --

 

Greetings,

 

I have been reading over the latest DFA 18, about cosmetics, and the possible route of BSE, through this source. Several interesting comments I find, that have brought several questions in mind, ones in which I have asked before, and still no answer. The CDC refuses to answer any of my questions through their site, and no one else seems to know the answer. Is the U.S.A. considered to be B.S.E. free, by other Countries? I asked this question to Dr. Detwiler, her reply was; "To the best of my knowledge there are no countries in the world which restrict any animals or animal products from the United States due to a risk from BSE. I am not sure if all such countries are using the term BSE free"...

 

The reason in bringing this up, I find several statements in this draft, that pertains to this, statements that I find quite interesting;

 

Page 24, DFA 18, -- "the line taken on cosmetics including sourcing from overseas was based on that given for licensed medicinal products by a group that included Drs. Kimberlin, Watson and Will, as well as other MAFF officials. There is no question that the UK is an "infected area": the only question is whether other countries should be included too. The Licensing Authority, quite reasonably in my view, feels they can only insist on sourcing in Countries where there is no evidence of BSE and the veterinary service and reporting system is adequate to detect it were it is present. Most manufacturers of mainline pharmaceuticals are not risking having to change sources yet again and so are looking to Australasia. If the CVO thinks he has enough evidence, _say concerning the USA_, to persuade the CSM, CDSM etc to advise more strongly against sourcing there too, he should present that evidence in a convincing form and in writing. I do not see this as a matter for our group, since there are statutory responsibilities under the Medicines Act. What we should do is ensure consistent advice is given for those borderline products (like these "cosmetics" with medicinal claims) that currently fall outside that Act."

 

Page 60, DFA 18, cosmetics -- 4. If it is possible for humans to contract "mad cow" disease from cosmetics, the risk is greater from "exotica" products because, unlike soap ingredients, the ingredients are not subject to repeated boiling and some are just merely chilled. MAFF have advised the CTPA that the only safe source is Australasia. Along with other European countries, France and Germany have imported from the UK infected feedstuff and live cattle. There have been reports of BSE outbreaks in Germany and France and _even in the USA_, a prime market for Jersey cattle. The Germans claim that they have "cured" their infected cattle by bathing them in a special dip they have developed but MAFF say there is no magic German cure. The French are masters at suppressing bad news. However, their higher scientific committee has issued "approved BSE guidelines" for French industry to follow. These guidelines cover, amongst other things, cosmetic products and are based on guidelines issued by MAFF. The French have not credited MAFF at all and are touting their guidelines around the Commission.

 

I suppose my question would still be, does the EU, and or all the rest of the European Countries, consider the U.S.A. to be B.S.E. Free?

 

------------------ http://www.uni-karlsruhe.de/~listserv/ -------------------

 


 

 Subject: COSMETICS, TOILETRY AND THE PERFUME INDUSTRY & B.S.E.

 

From: "Terry S. Singeltary Sr."

 

Reply-To: Bovine Spongiform Encephalopathy

 

Date: Sun, 3 Sep 2000 10:55:19 -0700

 

Content-Type: text/plain

 

Parts/Attachments: text/plain (305 lines)

 

Reply

 

######### Bovine Spongiform Encephalopathy #########

 

Greetings List Members,

 

Human transmission: There are some in the media and even the medical profession who are trying to make connections between BSE and the human disorder CJD. There is _no_ evidence of any association nor would we expect any cases by now even were BSE to be transmissible to humans. Dr Wills' study (see 2i above) will monitor the situation for the next decade or two.

 

I thought i would break off the vaccines & BSE related issues just briefly, to show you another fine example of the, hmmmmmmmm, i will not use _cover-ups_, because people cannot accept that, even if that is where the truth lies. So i will call them, the _purposely miss judgements_, or _happen-stances of mega-ignorance_.

 

kind regards, Terry S. Singeltary Sr., Bacliff, Texas USA

 

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

 

dti

 

Miss Marion Kelly Cosmetic, Toiletry and Perfumery Association 35 Dover Street London W1X3RA

 

Department of Trade and Industry

 

10-18 Victoria Street London SW1H ONN

 

Enquiries 01-215 5000

 

Telex 8811074 DTHQ G

 

01 215 3324

 

1 February 1990

 

Dear Marion

 

As you know there is no record of bovine spongiform encepalopathy crossing to humans, but we need to take precautions to avoid any risk.

 

There a number of cosmetric products on sale in the United Kingdom such as anti-ageing creams that contain extracts of bovine offal, primarily from spleen and Thymus.

 

The purpose of this letter is to ask you to ask your members to eliminate any risk by reformulating such products to eliminate these extracts, or alternatively to use material derived from cattle reared outside the UK, Eire or the Channel Islands.

 

Please let me know if you have any trouble persuading your members to do so.

 

Yours sincerely

 

R J ROSCOE

 

CONSUMER SAFETY UNIT

 

ROOM 407

 

90/02.01/14.1

 

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

 

BSE110/1 0080

 

DEPARTMENT OF HEALTH AND SOCIAL SECURITY HANNIBAL HOUSE Room No ELEPHANT AND CASTLE LONDON SE1 6TE

 

1 February 1990

 

Mr R Roscoe Consumer Affairs Department of Trade and Industry 10-18 Victoria Street London SW1

 

Dear Richard

 

USE OF BOVINE OFFAL IN COSMETICS

 

I am replying to your request for advice on the safety of the use of extracts of bovine offal in certain cosmetics, such as skin products claimed to have 'anti-ageing' properties with respect to bovine spongiform encephalopathy (BSE). As you are aware there are a number of cosmetic products on sale in the UK that contain small amounts of such extracts, primarily from spleen and thymus.

 

we accept that the risk of transmission is likely to be remote, but believe that it would be prudent to eliminate any risk by reformulating such products. Alternatively if the incorporation of bovine extracts is retained, material derived from cattle reared outside the UK, Eire or the Channel Islands should be used.

 

We would be grateful if you would transmit these recommendations to industry via the Trade Association CTPA.

 

I attach background briefing prepared by medical colleagues from those sections most involved with consideration of BSE in DH, together with a copy of the Southwood report.

 

Please let me know if you need any further information.

 

Yours sincerely

 

DR R J FIELDER

 

Enclosure

 

90/2.1/7.1

 

===========

 

BSE110/1 0081

 

BACKGROUND BRIEFING

 

presence of Bovine Offals in Cosmetics and Bovine Spongiform Encephalopathy

 

(1) Extracts of bovine spleen and thymus are present at between ca 0.1 and 5% in certain cosmetic preparations, for example certain products claimed to delay the signs of ageing of skin. The concern about the increasing incidence of BSE in cattle in the UK has made it necessary to reconsider the safety of such products.

 

The disease

 

BSE is a progressive neurological disorder in cattle, which results from infection with an "unconventional viral' agent. The first case was described in cows in 1986. By 19 January 1990 there had been 9436 confirmed cases in the UK on 5474 farms. There are no confirmed cases outside the British Isles, apart from a case in a cow recently exported from England. BSE is one of a family of spongiform encephalopathies which also include scrapie in sheep and kuru and Creutzfeldt Jakob disease (CJD) in man. The infection which leads to BBE appears to have been introduced into cattle from the contaminated feeding stuff, meat and bone meal, made partly from sheep offal: scrapie is endemic in sheep in the UK.

 

The causative agents of these diseases are thought to be unconventional transmissible agents (referred to variously as prions, virinos, filamentous viruses or slow viruses). They are extremely resistant to most denaturing processes eg heat, UV, high salt concentration, formalin and alkylating agents. The current DH guideline for treating items used on CJD patients is a temperature of 134-138 C (at 2 atmospheres) held for 18 minutes. They are also not removed by normal microbiological filters. It is thus unlikely that the mild processing techniques used to obtain the extracts used in cosmetics would remove the causative agents.

 

(2) Government action to date includes:

 

a. An expert working party was set up under Sir Richard Southwood and reported in February 1989. All their recommendations have been acted upon.

 

b. The disease has been made notifiable in cattle.

 

c. All suspect animals are slaughtered and carcases destroyed (50% compensation policy but 100% if diagnosis not confirmed); milk from such animals is also destroyed.

 

d. Sale or supply of animal protein from ruminants for feeding to ruminants prohibited - hopefully to prevent any new infections in cattle. This has had a major effect on the rendering industry.

 

e. Another committee was set up under Dr David Tyrrell to report on research needs. An interim report was published in January 1990 together with an announcement about additional funding. Much research work into the disease is currently in progress and additional studies are being planned.

 

Regulations in November 1989 introduced a ban on various

 

90/2.1/7.2

 

===========

 

BSEllO/1 0082

 

bovine offal for human consumption, going wider than the Southwood recommendations which were for such a ban to affect baby food only.

 

The Medicines Control Agency have gathered information from pharmaceutical companies about use of bovine ingredients in parenteral pharmaceuticals and issued interim guidelines. Many biological products and vaccines use such ingredients. The MCA are considering whether action on specific products is appropriate.

 

h. The Health and Safety Executive (HSE) is reviewing its guidance to those who come into direct contact with bovine 'risk' tissues. A press release for those who handle BSE carcases has been issued and one for abattoir workers is in preparation. The HSE ara also discussing risks from BSE exposure with the veterinary profession.

 

i. All UK cases of CJD will be monitored in a study to be conducted by Dr R G Will in Edinburgh, funded by the Department of Health: this should allow detection of any spread of infection to hummans, although this possibility is considered remote.

 

(3) Current live issues

 

Research: Dr Tyrell's interim report identified a large research programme classed as high priority. Almost all of this research falls to MAFF {Central Veterinary Labs} or the AFRC, although the MRC also has an interest. Substantial money has been made available for this work but research will be laborious and results will come slowly.

 

Food: There has been constant pressure on MAFF about the supposed risk to humans from eating beef and beef products. Infected animals who are incubating the disease but do not show any abnormalities cannot be detected at present and will be entering the human food chain. The offal ban removes the highest 'risk' tissues. Some critics may not be satisfied by this. However, others may argue the action to date is over the top, not demanded by the experts, and illogical since scrapie-infected sheep can still be eaten and doing so for the last 200 years has not caused harm to humans. We expect BSE agent to be resistant to irradiation as applied to food, as well as relatively resistant to cooking.

 

Other animals: There is no evidence that animals other than cattle (and domesticated, deer) have been or could be affected by BSE, other than experimentally, but there are pressures to extend the ruminant protein ban: at present pigs and poultry receive this sort of feed. Such action, as well as being hard to justify scientifically, would increase costs for the industry and cause perhaps insurmountable problems for abattoirs, who would find renderers no longer willing to accept offal. Many 1000's of tons of offal need to be disposed of daily.

 

Compensation: This has been set at 50% for BSE, although for some other diseases it is higher. Some critics believe this encourages evasion, with cows affected minimally being sent for human consumption. Even the current level of compensation is proving expensive for MAFF.

 

Exports: Some foreign countries have banned British exports of seman, embryos and livestock. The EC now no longer accepts live cattle over 6 months of age. The Germans are creating difficulties over beef exports too. The EC are also considering making BSE

 

90/2.1/7.3

 

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

 

BSE110/1 0083

 

notifiable and banning ruminant protein feeding to rminants, as we have done here. At present, British meat and bone meat can still be exported and might spread infection overseas (MAFF claim importers have been warned that it is not regarded suitable for feeding to ruminants).

 

Human transmission: There are some in the media and even the medical profession who are trying to make connections between BSE and the human disorder CJD. There is _no_ evidence of any association nor would we expect any cases by now even were BSE to be transmissible to humans. Dr Wills' study (see 2i above) will monitor the situation for the next decade or two.

 

90/2.1/7.4

 

=========== [like i have said, they really did miss the boat on this whole ordeal. from day one, to date, and they still continue to deny the inevitable.] TSS

 

=========== [also, found this in this pile, so will just add...tss] ===========

 

BOVINE SPONGIFORM ENCEPHALOPATHY

 

I have been asked to provide a draft reply to the attached letter from Sir Richard Southwood to the Minister. The Minister has indicated that we must meet Sir Richard's points (a} on the need for him to be fully briefed as to developments and (b) on the urgency of making progress with the transmission study.

 

On (a), I would suggest that the draft reply should indicate that you will be in touch with Sir Richard regularly to keep him in the picture. On (b), I hope we can now tell Sir Richard that the arrangements for the purchase and relocation of the animals are under way.

 

A R Cruickshank

 

20 June 1989

 

Mr A J Lawrence

 

AH

 

cc Mr K C Meldrum Dr W A Watson Mr R C Lowson

 

89/6.20/8.1

 

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

 


 


 

 From: TSS (216-119-138-155.ipset18.wt.net)

 

Subject: FAT LIPS/SHINY HAIR/Creams (Cosmetics) PRETTY WOMEN $ MOVIE STARS $ MAD COW DISEASE ...

 

Date: June 10, 2001 at 8:24 am PST

 

Greetings ALL,

 

was reading a 'smut' magazine about the 'babes' and came across this article about the different movie stars 'fat lips' (collagen injections). something in the article caught my eye. ONE was Collagen and the other was HASK PLACENTA No-Rinse Treatment. (if containing animal tissues, and then running down into the eye's, seems like a potential transmission route, if you consider kuru and the fact transmission of that TSE agent via topical applications {rubbing of organs etc on skin, cuts etc...TSS}).

 

""Attention, Goldie Hawn: You might want to forget about more collagen infections for that full-lipped look. Collagen for the procedure usually comes from cows -- as in "mad cow disease". So what's a girl to do? Some docs are using an acid found in roosters' combs instead of collagen. Others use collagen from 'ELITE' herds that don't mix with common bovines. And one scientist is awaiting approval for a human collagen from the foreskin of infant boys -- further proof that beauty is only skin deep""-- 'The National Enquirer' 5/6/01

 

are these babes in far a 'rude' awakening. firstly, these so called 'ELITE' herds they speak of, are what they call, 'tissue donor herds', that are suppose to be fed 'only' certain products that _do not_ include ruminant feed of any sort. AND from the exact question i asked at the infamous '50 STATE EMERGENCY CONFERENCE CALL' of Jan, 9, 2001, sadly we find, there is absolutley, NO SUCH THING. It was all a joke. The 'partial' ruminant to ruminant feed ban of August 4, 1997, never was enforced, and most knew nothing about it, and/or chose to ignore it.

 


 

Hask Placenta® No-Rinse Hair Repair Treatment

 

Nature's protein treatment. Excellent for hair that is abused by relaxing, tinting, bleaching and exposure to the sun.

 

Price: US$4.95 Package: 5 fl oz (150 ml) Item No.: P8225 **discontinued** - replaced by Perm-Aid® No-Rinse Conditioning Treatment

 

Placenta, the most powerful natural protein for the hair instantly restores life and luster to day brittle hair.

 

Directions:

 

Shake well. Apply after shampooing. Use pump and spray until hair is saturated. Massage thoroughly. Do not rinse. Wait 3 minutes: proceed as usual with setting or styling.

 

Ingredients:

 

Water, SD Alcohol 40, Placental Protein, Cetrimonium Bromide, Lactic Acid, Fragrance, Stearamide MEA, Polysorbate 80, Phenoxyethanol, Methylparaben, Butylparaben, Propylparaben, Stearyl Imidazoline, Cetearyl Alcohol, Dimethicone, FD&C Yellow #5.

 


 

Hask Perm-Aid® Revitalizing Treatment

 

Special care for permed hair, also for chemically damaged and extremely abused hair.

 

Price: US$3.95 Package: 2.5 oz (70.94 grams) Item No.: P8216 Availability: **discontinued** recommend Perm-Aid No Rinse Conditioning Treatment

 

This product had been discontinued by the manufacturer, we recommend Perm-Aid® No Rinse Conditioning Treatment, which is more potent!

 


 

Part No : 1227 Description : Hask Placenta Treat.Vial 24/unit

 

This product is in stock, and will ships in one to two business day. If the order is received before 1:00 pm Pacific Time, usually ships on same business day.

 


 

HASK PLACENTA products are leaders in the Deep Conditioner segment of Hair Care. Henna-n-Placenta Pacs are #13 in Unit Sales of ALL conditioners and #1 of all DEEP conditioners in the Drug Class*. Hask Placenta Instant Hair Repair, with No-Rinse treatment, is a top-10 unit seller*. National Media Support drives the brand and Hask’s strong professional heritage has consumer recognition.

 


 

BSE INQUIRY

 

Use of Bovine offal in Cosmetics;

 


 


 

6. Information on the transfer of spongiform encephalopathies indicates that the risks from parenternal exposure are greater than orally; though the transfer through intact skin is probably unlikely, the effect of a cut or abrasion to the skin is unknown. ...

 


 


 


 


 

 *** (Third paragraph: The wording of this paragraph will raise NEW concerns which cannot be scientifically answered. We would ask that the third paragraph be OMITTED.)

 


 

 NOT FOR PUBLICATION

 


 

 (there may still be some strange products administered by injection that are trying to _evade_ the Medicines Act by calling themselves cosmetics. If _any_ of those involve bovine ingredients, they need to _comply_ with the CSM guidelines)...

 


 


 


 


 


 

BSE110/1 0180

 

RUMINANT-DERIVED MATERIAL IN COSMETICS

 

The Department of Health wishes to reinforce the advice given to the Cosmetics Industry in February 1990 (ref.)

 

It is possible that some ruminant-derived materials are being incorporated into cosmetics or beauty treatments which are then marketed as 'natural products.

 

The particular materials that should not under _ANY_ circumstances be used in the manufacturer of cosmetics or beauty treatments are:

 

1. bovine (cattle)-derived offals, or proteins derived from these offals. These offals are: brain, spinal cord, spleen, thymus, tonsils, intestines of Bovine offal (prohibition) regulations

 

2. ovine (sheep)-derived offals and ovine placenta.

 

In view of the current uncertainty about the incidence of infection with spongiform encephalopathy agents it is probably advisable that these recommendations apply to the above ruminant-derived materials of ANY COUNTRY OF ORIGIN...

 

31 October 1991

 

91/10.31/9.1

 

It also emerged from the 16- volume report of Lord Phillips, released on Thursday, that people who bought anti-aging cream may have exposed themselves to BSE unwittingly.

 

The report describes their use as “a potential pathway to infection” because some creams may have included cattle brain placenta.

 


 

A CONSIDERATION OF THE POSSIBLE HAZARD OF GELATIN TO MAN IN RELATION TO THE TRANSMISSION OF BSE

 


 

 Subject: BSE aka MAD COW DISEASE AND TOPICAL APPLICATIONS COSMETICS (cuts/abrasions etc.)

 

From: "Terry S. Singeltary Sr."

 

Reply-To: Bovine Spongiform Encephalopathy

 

Date: Wed, 12 Sep 2001 16:51:36 -0700

 

Content-Type: text/plain

 

Parts/Attachments: text/plain (257 lines)

 

Reply

 

######## Bovine Spongiform Encephalopathy #########

 

Greetings everyone,

 

since the debate on this ended abruptly, i thought some might be interested in the following;

 

TOSS =====

 

DOA 18

 

Cosmetics

 

snip...

 

73. On 29 January 1990 Dr Pickles sent a minute to Dr Singh, copied to Mr Love and Mr Maslin. Dr Pickles referred to a conversation about Dr Singh’s draft letter to Mr Roscoe, and stated:[73]

 

snip...

 

But I think application to broken skin is getting rather close to parenteral administration. Together with problems of policing the 6 month limit, and the fact that the ‘benefit’ from such material is so dubious, I would prefer to see a complete ban.’

 

snip...

 

75. On 29 January 1990 Mr Sloggem replied to Mrs Shersby’s minute of the same date. He said:[75]

 

“1. The advice from Dr Fielder seems fine to me. There could be a problem with abraded skin providing a route of entry. Spleen and placenta could well have high titres, assuming the analogy with scrapie holds good. Sourcing abroad would seem the sensible thing to do. Some tissues may have higher titres earlier than brain tissue eg gut, hence these are best avoided from British sources.

 

snip...

 

“… the line taken on cosmetics including sourcing from overseas was based on that given for licensed medicinal products by a group that included Drs Kimberlin, Watson and Will, as well as other MAFF officials. There is no question that the UK is an “infected area”: the only question is whether other countries should be included too. The Licensing Authority, quite reasonably in my view, feels they can only insist on sourcing in countries where there is no evidence of BSE and the veterinary service and reporting system is adequate to detect it were it present. Most manufacturers of mainline pharmaceuticals are not risking having to change sources yet again and so are looking to Australasia. If the CVO thinks he has enough evidence, say concerning the USA, to persuade the CSM, CDSM etc to advise more strongly against sourcing there too, he should present that evidence in a convincing form and in writing. I do not see this as a matter for our group, since there are statutory responsibilities under the Medicines Act. What we should do is ensure consistent advice is given for those borderline products (like these “cosmetics” with medicinal claims) that currently fall outside that Act.”

 


 

snip...

 

136. On 25 July 1991, Dr Pickles replied to Mr Murray’s request. She agreed that the geographical aspects needed updating. She said ‘[the] background briefing is not really appropriate in that form (it was not something I had intended should have gone to DTI in any case).’ She also suggested that it could be pointed out that there were potential concerns:[142]

 

‘* for workers in the cosmetic industry who may be exposed frequently to these materials, especially if inoculation injuries might occur and

 

* those who by repeated application particularly to thinned, scarified or diseased skin might absorb material including infective agent that way, also

 

* there may still be some strange products administered by injection that are trying to evade the Medicines Act by calling themselves cosmetics. If any of those involve bovine ingredients, they need to comply with the CSM guidelines.’

 

snip...

 

‘I have the feeling we are far too remote from the industry to make meaningful comments. Contacts via DOH/DTI do not inspire me with confidence. I would advise we need to know what bovine materials are really used in cosmetics and for what purposes. We either need to send someone into the industry (as I did for tripe, casings and rennet) or have a closer contact via the trade association. I am not satisfied yet that the industry is ‘in the clear’ and it is us that may shoulder some blame if it is later found ladies are rubbing cow brain or placenta on to their faces. It may not be our job but if we have any responsibility we need to get at the facts.’

 

snip...

 

‘Cosmetics

 

3. In February 1990 the Department of Health wrote to the Department of Trade and Industry, following a request for advice on the safety of using extracts of bovine offal in certain cosmetics. Placenta is used for its supposed anti-ageing properties. Gangliosides, spleen and thymus may also be used, although there is no firm knowledge on this.

 

4. DTI issued advice to the industry, via the Trade Association, to the effect that even though the risks were remote it would be prudent to reformulate these products or source from countries free from BSE. In this context it was agreed at the Tyrrell committee meeting on 28 June that DTI would be reminded that since BSE had been found in other countries their guidance to cosmetic manufacturers needed to be updated.

 

snip...

 

‘MK and JS said that the cosmetics of concern can be divided into two – 10% expensive ‘exotica’ which could contain the particular tissues of concern to DH such as cerebrocides, placenta (either human or other animal) and 90% are the routine products, many of which are based on collagen, elastin and gelatin. …

 

MK explained that the French cosmetics industry was soon to hold discussions with their Department of Health and it was likely that the use of placental material, particularly human, would be discontinued in any cosmetics. The main producers of ‘exotica’ were French and American, the products very expensive and therefore the companies would have the resources to ensure the safety of their products by safe sourcing eg from Australasia where there is no scrapie and no BSE. Small UK manufacturers would not be producing products containing animal materials but would rely on vegetable materials. They were not thought to be likely to be incorporating materials of concern, and this was also true for those producers of ‘natural’ products who would not necessarily be members of the CTPA.’

 

snip...

 

The delegation thought that cosmetic products applied to the mucous membranes or around the eyes were the most dangerous.

 


 


 

Subject: Use of Materials Derived From Cattle in Human Food and Cosmetics [Docket No. 2004N-0081] RIN 0910-AF47

 

From: "Terry S. Singeltary Sr."

 

Reply-To: Bovine Spongiform Encephalopathy

 

Date: Thu, 17 Apr 2008 12:46:56 -0500

 

Content-Type: text/plain

 


 

Subject: CHINA TO START IMPORTING COSMETICS FROM COUNTRIES WITH BSE

 

From: "Terry S. Singeltary Sr."

 

Reply-To: Bovine Spongiform Encephalopathy

 

Date: Sun, 1 Apr 2007 13:05:42 -0500

 

Volume 7 Medicines and Cosmetics 8. Cosmetics and toiletries Introduction Exotica Standard topical products Collagen implants How the issue was handled

 

8.1 In this chapter we consider the Government's response to the risks posed by the use of bovine material in cosmetics. Cosmetics, as defined by the Cosmetics Products (Safety) Regulations 1996, include:

 

any substance or preparation intended to be placed in contact with any part of the external surfaces of the human body (that is to say, the epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours except where such cleaning, perfuming, protecting, changing, keeping or correcting is wholly for the purpose of treating or preventing disease. 1

 

8.2 Cosmetics using bovine materials fell into three categories: (i) products using lightly treated high-risk bovine offals: 'exotica'; (ii) standard topically applied products using heavily processed bovine by-products; and (iii) implants using bovine collagen.

 

Exotica

 

8.3 Concern about a risk of possible BSE contamination focused mainly on those cosmetic products commonly described as 'exotica'. These included 'premium priced facial skin care products' such as certain anti-ageing and anti-wrinkle creams. There was no ban on the use in them of animal material such as 'cellular extracts' that was deemed an unacceptable risk in food and medicines, and accordingly proscribed under the food safety and medicines safety legislation. Such material might be only lightly processed or simply chilled. Possible ingredients identified relatively early on were gangliocides extracted from the brain; and placental material, spleen and thymus. 2

 

Standard topical products

 

8.4 Although never considered a serious risk, questions were also raised about how to ensure the safety of more standard cosmetic products. These included the full range of topically applied cosmetics, ie, creams and toiletries applied to the skin, lips and eyelids, and included soaps, skin creams, shaving sticks and stick deodorants. Many of these used heavily processed bovine by-products such as collagen, elastin, gelatine and tallow derivatives. 3

 

Collagen implants

 

8.5 Concern was also expressed about bovine collagen used in implants. Although not mentioned in the highly condensed minutes of the CSM/BSC meeting of 2 November 1988, Dr Pickles's own note at the time records that this came up at the meeting as an area of concern: 'Some collagen implants of bovine origin as used by cosmetic clinics are not even licensed.' 4 Collagen products intended for correction of contour deficiencies of the skin were considered licensable under the Surgical Materials Order SI 1971 No. 1276. DH has told us that although collagen implants might have been used for 'cosmetic' reasons, this would have been under medical supervision as they were 'prescription only' medicines. 5

 

How the issue was handled

 

8.6 Although specifically identified in the Tyrrell Report in June 1989 as a small-scale user that might not be covered by the regulations and guidelines then in place, 6 the cosmetics industry was not itself the subject of advice or guidance until February 1990.

 

8.7 In January of that year Mr Richard Roscoe of the Department of Trade and Industry (DTI), the Department with policy responsibility for the safety of cosmetics, had on his own initiative asked DH for advice about the risk from BSE associated with the use of bovine offal in certain cosmetics. 7 DH's advice was that although the risk of transmission of BSE was remote, it would be prudent to reformulate, or source bovine material from cattle reared outside the British Isles. 8 DTI passed this advice on to the cosmetics industry trade association, the Cosmetics, Toiletries and Perfumery Association (CTPA), which in turn informed its members. 9

 

8.8 SEAC considered the use of bovine material in non-food products generally in June 1991. 10 By that time, BSE had been identified in countries other than the UK, and it was suggested that the advice issued to the cosmetics industry in February 1990 should be updated to take this into account. Updated advice was not sent to the CTPA until April 1992. 11

 

8.9 One approach that was considered within DH was the introduction of a voluntary ban on bovine materials from countries in which cases of BSE had been reported. Such a ban, if it were to be introduced, would have to be implemented at EU level, so as not to fall foul of European law. The question of BSE and cosmetics was therefore taken forward in the EC Working Party on Cosmetics (ECWPC). Progress at EC/EU level was slow; by the end of October 1994 the Scientific Committee on Cosmetology (SCC) had produced only an interim statement suggesting that material from animals with the potential to transmit infectious agents should not be used in the manufacture of cosmetics. 12 In February 1995 the ECWPC decided that the existing Cosmetics Directive did not need alteration. 13 This decision was based in part on assurance by COLIPA, the European cosmetics trade association, that its members were following certain approved basic precautions on a voluntary basis. 14

 

8.10 When, in March 1996, the EU ban on the export from the UK of bovine products destined for use in cosmetic, medicinal and pharmaceutical products was introduced, 15 the CTPA conducted a survey of its members and reported that almost all had been using non-UK-sourced bovine material for some time. 16

 

8.11 In the sections that follow we look first at the regulatory framework on cosmetics safety, which was markedly different from that on either food or medicinal products safety. The sponsoring Department for the industry, which was also responsible for its regulation, was DTI. As we shall see, there was some confusion at various points in the sequence of events about the respective responsibilities of DTI and DH for minimising risks to human health from the production and use of cosmetic products.

 

8.12 In the final section of the chapter we review some lessons that emerge from the way BSE was handled.

 


 

Volume 7 Medicines and Cosmetics 8. Cosmetics and toiletries Regulatory framework Enforcement DTI handling of cosmetics DH's role in cosmetics safety

 

8.13 The regulation of cosmetics is based on the EU Cosmetics Directive (1976), which was implemented in the UK by regulations made under the Consumer Protection Act 1987. Under this system, cosmetic products must meet various safety requirements, but, unlike medicinal products, they do not require a licence.

 

8.14 The Cosmetics Directive seeks to ensure the safety of cosmetics and their unhindered trade throughout the EU. In relation to safety, Article 2 provides:

 

Cosmetic products put on the market within the Community must not be liable to cause damage to human health when applied under normal conditions of use. 1

 

8.15 Dr Robin Fielder of DH told us that the Cosmetics Directive places the onus on manufacturers and suppliers to ensure that the product is safe for the use intended. 2

 

8.16 Member States have a duty to 'take all necessary measures to ensure that only cosmetic products which conform to [the Directive] may be put on the market'. 3 The Annexes to the Cosmetics Directive list substances that must not be used in cosmetics and substances whose use is regulated. They also contain lists of substances ('the prescribed lists') permitted for certain uses (preservatives, colourants, sun screens) and only these substances may be used for those purposes in cosmetic products. 4 The prescribed lists may be amended following consideration by the European Commission's Cosmetic Products Working Party, which consists of representatives from the Member States and the industry. DTI led for the UK on this with DH also having a role. The final decision is taken by the Committee on the Adaptation to Technical Progress, which is chaired by the Commission and consists of representatives from Member States. Both the Working Party and the Commission have access to the opinions of the Scientific Committee on Cosmetology (SCC), an independent multidisciplinary body of scientists appointed by the Commission to assess the safety of cosmetics ingredients, as well as to advice from their own national scientific advisers. 5

 

8.17 The Cosmetics Directive limits the action individual Member States can take to regulate cosmetics. 6 If a product complies with the relevant Annex, the UK Government cannot prohibit its use unless, on the basis of a 'substantiated justification', it represents a hazard to health. 7

 

8.18 Regulations made, in part, under section 11 of the Consumer Protection Act 1987 give effect to the Cosmetics Directive in UK law. The Cosmetic Products (Safety) Regulations 1984 (made under a predecessor of the Act) were replaced on 1 January 1990 by the Cosmetic Products (Safety) Regulations 1989 ('the 1989 Regulations').

 

8.19 The main provisions of the 1989 Regulations are as follows: 8

 

1.A cosmetic product shall not be liable to cause damage to human health when it is applied under normal conditions of use (reg. 3(1)). 2.No cosmetic product may contain any substance listed in column 2 of Schedule 1, unless it is only a trace that could not reasonably have been removed during or after manufacture (reg. 4(2)). 3.A cosmetic product must not contain any substance listed in column 2 of Schedule 2 unless specified requirements in that schedule are satisfied (reg. 4(3)). 4.The Secretary of State may authorise the use in a cosmetic product of any substance not listed in either schedule 1 or 2 (reg. 5(1)). In giving authorisation the Secretary of State may impose conditions relating to the use of the substance (reg. 5(2)). 5.There are various conditions and standards for labelling and packaging (reg. 6).

 

8.20 The Consumer Protection Act imposes a general safety requirement on all consumer goods. Section 10 of the Act makes it an offence to supply consumer goods that fail to comply with the general safety requirement. For this purpose, consumer goods fail to comply with the safety requirement if they are not reasonably safe having regard to all the circumstances. 'Safe' means that there is no risk (apart from one reduced to a minimum) that the goods will (whether immediately or later) cause death or personal injury to any person. 9

 

8.21 The Cosmetics Directive and the 1989 Regulations left only limited scope for the application of section 10 of the Act. Since the introduction of the General Product Safety Regulations 1994 10 there has been virtually no scope for its application.

 

8.22 In practice informal contact and voluntary cooperation played an important part in the regulation of the cosmetics industry.

 

Enforcement

 

8.23 DTI had policy responsibility for the safety of cosmetics in the UK. Day-to-day enforcement of safety regulations such as the 1989 Regulations fell to the trading standards departments of local authorities. 11

 

8.24 Supplying consumer goods that failed to comply with the general safety requirement or with certain requirements of safety regulations was an offence and punishable in the courts. 12

 

8.25 In addition, enforcement authorities (which for these purposes meant DTI and the trading standards departments of local authorities) had power to serve a suspension notice prohibiting the person on whom it was served from supplying goods for up to six months; power to apply to the court for a forfeiture order; 13 and power for an authorised officer of the enforcement authority to enter any premises, inspect any goods, or examine any procedure, or in appropriate circumstances to seize and detain goods. 14

 

8.26 The Secretary of State also had the power to serve a notice on a person prohibiting the person from selling consumer goods if the Secretary of State considered them to be unsafe (a prohibition notice), or requiring the person to publish a warning about such goods (a notice to warn). 15 However, these powers applied only to the person on whom the notice was served or against whom the order was sought, rather than to a general category of goods, and no power existed to recall products under these provisions. 16

 

8.27 DTI told us that it was unaware of any instance in which these powers had been used in respect of a BSE risk in cosmetics. 17

 

DTI handling of cosmetics

 

8.28 Within DTI overall responsibility for the safety of cosmetics lay with the Consumer Safety Unit (CSU). Within the CSU, the Chemical Hazards Section (CHS) had day-to-day responsibility for cosmetics. 18

 

8.29 Mr David Jones, a Grade 5 official, was Head of the CSU until 1995. Mr Roscoe, a Grade 7 official, was Head of the CHS from 1983 to 1992, with specific responsibility for ensuring the safety of cosmetics sold in the UK. 19 He was succeeded by Mr John Walker. Mrs M L Payne, a Higher Executive Officer in the CSU from 1990, was responsible for developing policy on regulation covering chemicals, including ingredients used in cosmetics. 20

 

8.30 The CTPA was the peak representative body for the UK cosmetics industry and the channel through which DTI distributed cautionary guidance on BSE to cosmetics manufacturers.

 

DH's role in cosmetics safety

 

8.31 Although DTI had overall regulatory responsibility for cosmetics, DH also played a role as DTI's adviser on toxicity. 21 The relevant Division in DH was MED TEP (Medical Toxicology Environmental Protection), 22 later evolving into the HEF M (Health Aspects of Environment and Food Medical), 23 which would give advice when necessary.

 

8.32 Mr Roscoe told us that whenever the CHS was alerted to the presence of a potentially 'risky' ingredient in a particular cosmetic product it would refer the matter to DH. 24 Upon receipt of advice from DH, the CHS would then decide on a course of action. According to Mr Roscoe, DTI would always act on this advice 'unless there were very strong reasons for not doing so'. 25

 

8.33 Mr Roscoe also told the Inquiry that he believed that when DH encountered a new risk it was its responsibility to pass on the information to DTI. 26

 

8.34 The DH adviser on toxicology over the period of concern was Dr Fielder, who was assisted by Dr Dewhurst (1988-90), Dr Gott (1991-93) and Ms Mulholland (1993-97). 27

 


 

COSMETICS-further reading from the inquiry on this subject;

 


 


 


 


 


 


 

 Volume 7: Medicines and Cosmetics 8. Cosmetics and toiletries 1997/98

 

8.145 Although outside the period covered by the Inquiry, it is of interest to note the Cosmetics Directive was subsequently amended by Commission Directive 97/1/EC on 10 January 1997 to prohibit the use in cosmetics of:

 

Bovine, ovine and caprine tissues and fluids from the encephalon, the spinal cord and the eyes, and ingredients derived therefrom. 1 8.146 The Cosmetics Directive was further amended by Commission Directive 98/16/EC on 5 March 1998 to prohibit the use in cosmetics of: 2

 

(a) the skull, including the brain and eyes, tonsils and spinal cord of: - bovine animals aged 12 months, - ovine and caprine animals which are aged over 12 months or have a permanent incisor tooth erupted through the gum; (b) the spleens of ovine and caprine animals and ingredients derived therefrom. However, tallow derivatives may be used provided that the following methods have been used and strictly certified by the producer: - Transesterification or Hydrolysis at at least: 200ºC, 40 bars (40,000 hPa) for 20 minutes (glycerol and fatty acids and esters); - Saponification with NaOH 12 M (glycerol and soap); - Batch process: at 95ºC for three hours, or - Continuous process: at 140ºC, two bars (2000 hPa) for eight minutes or equivalent conditions.

 


 


 

8.227 These matters stretch well beyond our remit. However, it appears to us, as it did to the Tyrrell Committee, that cosmetics were indeed a potential pathway for pathogens, and that not enough was known about this. Future occasions could arise when, as with BSE, there needs to be a means of turning off the tap at source, rather than catching droplets downstream. Consideration might usefully be given to what powers and processes would assist this.

 


 


 


 

 9.63 Mr Bradley replied by letter dated 17 June 1990 to Dr Pickles's letter of 11 June. He stated in relation to A1d:

 

I have not got far with this. Where do fetal calves, placenta and uteri go and are any uses made of lymph nodes? Cosmetics, ointments, oils, indeed anything that is used on the skin (it could have a lesion) could presen an increased hazard. I have some concern over mesenteric lymph nodes though they are not eaten, though DOH/MAFF agreed earlier there was no need to include them in the offal ban. This is one to discuss in Committee. 34

 

I understand that there is concern on the Tyrrell Committee recommendation A1d on pharmaceuticals and cosmetics. This has never been considered a primary responsibility of MAFF although collaboration with the principals (DOH and industry) was anticipated.

 

I suspect the VMD approach will be to avoid or selectively reduce use of bovine tissues in medicinal products for animals. Presumably the authorities responsible for human medicinal products and cosmetics have taken similar action. 35

 


 

 (iii) Non-food uses of bovine material. The Committee asked for a note on the use of bovine material for cosmetics in particular, although it might make sense to cover all the non-food uses that we can think of (harp strings, tennis rackets etc). I think that all that is required is a factual note about the range of uses, and quantities, together with an assessment of possible risk factors. It looks to me like a job for Dr Pickles. 1

 


 


 


 


 


 

 Annex 2 to Chapter 9: Uses made of the cattle carcass

 

Item Products derived Additional comments

 

HEAD

 

Brain Human food Laboratory reagents Veterinary medicines Pharmaceuticals Cosmetics

 


 


 


 


 


 


 


 

 4.4 On 10.1.90 I attended the second meeting of the CSM BSE Working Party. The discussions which took place and the conclusions reached can be found in the Minutes of the meeting [YB 90/1.10/1.1-1.24]. I provided comments to Dr Singh in Med TEH on his draft letter to DTI which responded to a request for advice on the safety of the use of bovine offal (in particular, spleen and thymus) in cosmetics [YB 90/1.29/1.1-1.2]. My briefing notes were used to accompany the reply to DTI [YB 90/2.1/4.1]. I indicated I was not happy about the use of bovine offal from calves under 6 months in cosmetics (in contrast to foods) because on damaged skin such use could be close to parenteral administration so the nearest parallel might be injectable medicines. Besides there were no compensating benefits.

 

57. April 1990

 

57.1 The formation of SEAC was announced by Mr Gummer on 3.4.90 [YB 90/5.24/4.1-4.2]. As requested, I supplied comments on the draft Agenda prepared by Mr Lowson for SEAC's first meeting [YB 90/4.6/4.1-4.3] and I supplied a list of documents to accompany the formal papers for background information. I offered to put together a discussion paper on bovine eyeballs and the use of bovine material in cosmetics. This draft paper entitled Routes of Possible Transmission into Man was later sent to Mr Lowson for comment [YB 90/4.12/1.1-1.4]. It met with the approval of Mr Lowson but it was not submitted to SEAC at that time as CVO indicated he thought a more detailed paper was needed [YB 90/4.24/3.1-3.2 and see YB 90/4.23/1.1].

 


 


 


 


 

Content-Type: text/plain

 


 

BSE Inquiry report criticises ex-Tory ministers

 

Sat, Sep 2, 2000 PA News

 

Conservative former ministers and Whitehall officials face strong criticism in the official report into the BSE crisis, it was reported tonight. The inquiry chairman Lord Phillips is believed to have notified several former health and agriculture ministers that they are facing criticism in the 13-volume report he is to publish in a few weeks.

 

Reports in several Sunday newspapers suggested the former ministers would be taken to task for being "too adamant" in their assurances that British beef was safe, and for failing to react swiftly enough to scientists' findings that the disease could spread to humans. Scientists first suspected that there was a risk to humans eating BSE-infected offal in the mid-80s, but it was not until March 1996 that Tory ministers admitted that there was a danger to the public.

 

But the ex-ministers could come off lightly compared with senior civil servants who ran the two departments as the decade-long saga unfolded.

 

Lord Phillips' two-year inquiry is said to have concluded that too much importance was attached to the interests of the livestock industry, and not enough to those of consumers. The BSE affair led to a worldwide ban on British beef exports which is estimated to have cost the taxpayer 4.6 billion.

 

Comment (webmaster): It is unclear why the judge released the findings prior to publication. What purpose is served anyway with polite criticism (1, 2) of long-departed political figures and retired civil servants? Keith Meldrin, who masterminded the coverup within MAFF for 10 years, also receives a wrist-slap for a leading role in 82 human deaths. His successor at MAFF who continued these abominable policies was forced into retirement this year but given a handsome 400,000 pound retirement package. MAFF itself has spent 7 million pounds of public money on lawyers even and successfully fought the Inquiry practise of publishing fulltext of government memos on the Internet.

 

However, these documents can still be obtained in print form. Terry S. Singeltary Sr. of Bacliff, Texas, has obtained many of the documents alluded to in the Inquiry but never released. These have been optically character read into electronic form and distributed to the German BSE listserve archive as well as to this web site:

 

BSE offals used in cosmetics, toiletry and perfume industry

 

Sun, 3 Sep 2000. Unpublished Inquiry documents obtained by CJD activist Terry S. Singeltary Sr. of Bacliff, Texas

 

Miss Marion Kelly Cosmetic, Toiletry and Perfumery Association 35 Dover Street London W1X3RA

 

Department of Trade and Industry 10-18 Victoria Street London SW1H ONN Enquiries 01-215 5000 Telex 8811074 DTHQ G 01 215 3324 1 February 1990

 

Dear Marion

 

As you know there is no record of bovine spongiform encepalopathy crossing to humans, but we need to take precautions to avoid any risk.

 

There a number of cosmetric products on sale in the United Kingdom such as anti-ageing creams that contain extracts of bovine offal, primarily from spleen and thymus. [Two of the highest risk tissues. Note the epidemic has been raging for 4 years by the time of the non-binding voluntary suggestions here. -- webmaster]

 

The purpose of this letter is to ask you to ask your members to eliminate any risk by reformulating such products to eliminate these extracts, or alternatively to use material derived from cattle reared outside the UK, Eire or the Channel Islands. [Eire, Channel Islands, and many other countries were thoroughly infected by then -- webmaster]

 

Please let me know if you have any trouble persuading your members to do so.

 

Yours sincerely

 

R J ROSCOE CONSUMER SAFETY UNIT ROOM 407

 

90/02.01/14.1 ==============

 

BSE110/1 0080

 

DEPARTMENT OF HEALTH AND SOCIAL SECURITY HANNIBAL HOUSE Room No ELEPHANT AND CASTLE LONDON SE1 6TE

 

1 February 1990

 

Mr R Roscoe Consumer Affairs Department of Trade and Industry 10-18 Victoria Street London SW1

 

Dear Richard

 

USE OF BOVINE OFFAL IN COSMETICS

 

I am replying to your request for advice on the safety of the use of extracts of bovine offal in certain cosmetics, such as skin products claimed to have 'anti-ageing' properties with respect to bovine spongiform encephalopathy (BSE). As you are aware there are a number of cosmetic products on sale in the UK that contain small amounts of such extracts, primarily from spleen and thymus.

 

We accept that the risk of transmission is likely to be remote, but believe that it would be prudent to eliminate any risk by reformulating such products. Alternatively if the incorporation of bovine extracts is retained, material derived from cattle reared outside the UK, Eire or the Channel Islands should be used.

 

We would be grateful if you would transmit these recommendations to industry via the Trade Association CTPA.

 

I attach background briefing prepared by medical colleagues from those sections most involved with consideration of BSE in DH, together with a copy of the Southwood report.

 

Please let me know if you need any further information.

 

Yours sincerely DR R J FIELDER Enclosure 90/2.1/7.1 ===========

 

BSE110/1 0081

 

BACKGROUND BRIEFING

 

Presence of Bovine Offals in Cosmetics and Bovine Spongiform Encephalopathy

 

(1) Extracts of bovine spleen and thymus are present at between ca 0.1 and 5% in certain cosmetic preparations, for example certain products claimed to delay the signs of ageing of skin. The concern about the increasing incidence of BSE in cattle in the UK has made it necessary to reconsider the safety of such products.

 

BSE is a progressive neurological disorder in cattle, which results from infection with an "unconventional viral' agent. The first case was described in cows in 1986. By 19 January 1990 there had been 9436 confirmed cases in the UK on 5474 farms. There are no confirmed cases outside the British Isles, apart from a case in a cow recently exported from England. BSE is one of a family of spongiform encephalopathies which also include scrapie in sheep and kuru and Creutzfeldt Jakob disease (CJD) in man. The infection which leads to BBE appears to have been introduced into cattle from the contaminated feeding stuff, meat and bone meal, made partly from sheep offal: scrapie is endemic in sheep in the UK.

 

The causative agents of these diseases are thought to be unconventional transmissible agents (referred to variously as prions, virinos, filamentous viruses or slow viruses). They are extremely resistant to most denaturing processes eg heat, UV, high salt concentration, formalin and alkylating agents. The current DH guideline for treating items used on CJD patients is a temperature of 134-138 C (at 2 atmospheres) held for 18 minutes. They are also not removed by normal microbiological filters. It is thus unlikely that the mild processing techniques used to obtain the extracts used in cosmetics would remove the causative agents.

 

(2) Government action to date includes:

 

a. An expert working party was set up under Sir Richard Southwood and reported in February 1989. All their recommendations have been acted upon.

 

b. The disease has been made notifiable in cattle.

 

c. All suspect animals are slaughtered and carcases destroyed (50% compensation policy but 100% if diagnosis not confirmed); milk from such animals is also destroyed.

 

d. Sale or supply of animal protein from ruminants for feeding to ruminants prohibited - hopefully to prevent any new infections in cattle. This has had a major effect on the rendering industry.

 

e. Another committee was set up under Dr David Tyrrell to report on research needs. An interim report was published in January 1990 together with an announcement about additional funding. Much research work into the disease is currently in progress and additional studies are being planned.

 

Regulations in November 1989 introduced a ban on various bovine offal for human consumption, going wider than the Southwood recommendations which were for such a ban to affect baby food only.

 

The Medicines Control Agency have gathered information from pharmaceutical companies about use of bovine ingredients in parenteral pharmaceuticals and issued interim guidelines. Many biological products and vaccines use such ingredients. The MCA are considering whether action on specific products is appropriate.

 

h. The Health and Safety Executive (HSE) is reviewing its guidance to those who come into direct contact with bovine 'risk' tissues. A press release for those who handle BSE carcases has been issued and one for abattoir workers is in preparation. The HSE ara also discussing risks from BSE exposure with the veterinary profession.

 

i. All UK cases of CJD will be monitored in a study to be conducted by Dr R G Will in Edinburgh, funded by the Department of Health: this should allow detection of any spread of infection to hummans, although this possibility is considered remote.

 

(3) Current live issues

 

Research: Dr Tyrell's interim report identified a large research programme classed as high priority. Almost all of this research falls to MAFF {Central Veterinary Labs} or the AFRC, although the MRC also has an interest. Substantial money has been made available for this work but research will be laborious and results will come slowly.

 

Food: There has been constant pressure on MAFF about the supposed risk to humans from eating beef and beef products. Infected animals who are incubating the disease but do not show any abnormalities cannot be detected at present and will be entering the human food chain. The offal ban removes the highest 'risk' tissues. Some critics may not be satisfied by this. However, others may argue the action to date is over the top, not demanded by the experts, and illogical since scrapie-infected sheep can still be eaten and doing so for the last 200 years has not caused harm to humans. We expect BSE agent to be resistant to irradiation as applied to food, as well as relatively resistant to cooking.

 

Other animals: There is no evidence that animals other than cattle (and domesticated, deer) have been or could be affected by BSE, other than experimentally, but there are pressures to extend the ruminant protein ban: at present pigs and poultry receive this sort of feed. Such action, as well as being hard to justify scientifically, would increase costs for the industry and cause perhaps insurmountable problems for abattoirs, who would find renderers no longer willing to accept offal. Many 1000's of tons of offal need to be disposed of daily.

 

Compensation: This has been set at 50% for BSE, although for some other diseases it is higher. Some critics believe this encourages evasion, with cows affected minimally being sent for human consumption. Even the current level of compensation is proving expensive for MAFF.

 

Exports: Some foreign countries have banned British exports of seman, embryos and livestock. The EC now no longer accepts live cattle over 6 months of age. The Germans are creating difficulties over beef exports too. The EC are also considering making BSE notifiable and banning ruminant protein feeding to rminants, as we have done here. At present, British meat and bone meat can still be exported and might spread infection overseas (MAFF claim importers have been warned that it is not regarded suitable for feeding to ruminants).

 

Human transmission: There are some in the media and even the medical profession who are trying to make connections between BSE and the human disorder CJD. There is _no_ evidence of any association nor would we expect any cases by now even were BSE to be transmissible to humans. Dr Wills' study (see 2i above) will monitor the situation for the next decade or two.

 

I have been asked to provide a draft reply to the attached letter from Sir Richard Southwood to the Minister. The Minister has indicated that we must meet Sir Richard's points (a} on the need for him to be fully briefed as to developments and (b) on the urgency of making progress with the transmission study.

 

On (a), I would suggest that the draft reply should indicate that you will be in touch with Sir Richard regularly to keep him in the picture. On (b), I hope we can now tell Sir Richard that the arrangements for the purchase and relocation of the animals are under way.

 

A R Cruickshank 20 June 1989 Mr A J Lawrence AH cc Mr K C Meldrum Dr W A Watson Mr R C Lowson 89/6.20/8.1

 


 

update

 


 


 


 


 

Sunday, January 17, 2016

 

Of Grave Concern Heidenhain Variant Creutzfeldt Jakob Disease

 


 

Saturday, February 13, 2016

 

The Risk of Prion Infection through Bovine Grafting Materials in dentistry

 


 

Saturday, February 6, 2016

 

*** Secretary's Advisory Committee on Animal Health; Meeting [Docket No. APHIS-2016-0007] Singeltary Submission ***

 


 

Terry S. Singeltary Sr.

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