***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
============
############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html
############
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. ...
http://web.archive.org/web/20030516061153/http://www.bseinquiry.gov.uk/files/yb/1990/01/26018001.pdf
http://web.archive.org/web/20030526094945/http://www.bseinquiry.gov.uk/files/yb/1990/01/29015001.pdf
http://web.archive.org/web/20030515204421/http://www.bseinquiry.gov.uk/files/yb/1990/01/31014001.pdf
*** (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)...
http://web.archive.org/web/20030529120226/http://www.bseinquiry.gov.uk/files/yb/1991/06/30001001.pdf
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.
