Monday, May 30, 2011

CEPs for gelatin and impact of the revised EU Note for Guidance on the TSE risk EMEA/410/01 Rev.3) will come into force in July 2011

Note concerning CEPs for gelatin and impact of the revised EU Note for Guidance on the TSE risk

(23/05/11) Revision 3 of the EU "Note for Guidance on minimizing the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products" (EMEA/410/01 Rev.3) will come into force in July 2011 and introduces a new requirement for gelatin obtained from bones, which is based on the intended use of the finished product. Gelatin introduced in products for parenteral use should only be manufactured from bones sourced from OIE categories A or B countries, whereas gelatin for oral use may be manufactured from bones from any category of country.

The certificates of suitability granted for gelatin do not take into account the final use of the finished product. Therefore, where a CEP for gelatin is included in a marketing authorization, applicants/holders have to demonstrate in their application(s) for the relevant medicinal product(s), that the source of gelatin is suitable for the intended use. This will be approved by the licensing authorities evaluating the finished medicinal product.

http://www.edqm.eu/en/News-and-General-Information-164.html


Note for Guidance on minimizing the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products" (EMEA/410/01 Rev.3)


http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003700.pdf




http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003698.pdf



http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2011:073:0001:0018:EN:PDF



http://www.bpro.or.jp/publication/pdf_jptrans/eu/eu200105en.pdf



also see ;


http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000351.jsp&murl=menus/regulations/regulations.jsp&mid=WC0b01ac058002956c&jsenabled=true






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


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






Annex to the EFSA Scientific Report (2004) 3, 1-17 on the Assessment of the Geographical BSE Risk of USA

2.1 Import of cattle from BSE-Risk2 countries

An overview of the data on live cattle imports is presented in table 1 and is based on data as provided in the country dossier (CD) and corresponding data on relevant exports as available from BSE risk countries that exported to the USA. Only data from risk periods are indicated, i.e. those periods when exports from a BSE risk country already represented an external challenge, according to the SSC opinion on the GBR (SSC July 2000 and updated January 2002).

• According to the country dossier, 323 cattle were imported directly from the UK, all between 1980 and 1989, and 10 via Canada in 90, 91 and 92. According to Eurostat, 327 cattle were imported from UK. Of these cattle 96% were beef breeding cattle, 4% were dairy cattle. After 1989 an import stop for UK cattle was in effect.

• Cattle imported from the UK were traced-back in 1995. This trace back exercise provided the details on which the assessment of the HRS of the import risk assessment is based. The animals still alive in 1995 (117 cattle) have been purchased, diagnostic samples were taken, and the carcasses were incinerated. These animals were not taken into account for the external challenge. All these animals tested negative for BSE (histopathology and IHC). Of these 117 cattle 52 came from UK-herds in which one or more cases of BSE later on developed.

• For 173 cattle imported from the UK in the 80s, information on their final use is, according to the HRS, lacking and it is indicated that it is possible that some of these animals could have been rendered. In the HRS it is also noted that these animals were imported before the peak of the epidemic and none came from a birth cohort in which a BSE case is known to be developed. However, based on realistic worst case assumptions it has to be assumed that they created a risk if rendered for feed.

• EU export data show that from the EU (excluding UK), 1,663 cattle were exported to the USA since 1980; according to the CD only 460 cattle have been imported from the EU.

• According to the CD, 162 cattle were imported from Ireland between 1980 and 1988 (according to Eurostat 233). The trace back of these animals showed that 22 were found as being excluded from rendering in the US system and 4 were born in US quarantine and were therefore not taken into account for the external challenge.

• According to the CD, 6 cattle from Belgium (Eurostat also 6), 46 from Germany (Eurostat 430), 3 from Austria (Eurostat 0) and 8 from Italy (Eurostat 21) have been imported. The 40 breeding-cattle imported from these countries in 1996 and 1997 were all traced back and none of them entered the US system.

• According to Eurostat, 12 cattle from Denmark and 558 cattle from the Netherlands were imported to the USA. These imports were not indicated in the CD.

• Additionally according to the CD, 235 cattle have been imported from France (403 according to Eurostat) and 103 cattle from Switzerland (48 according to other sources).

• The discrepancy in the EU export data and the import data in the CD (See table 1) can in some cases, be explained by the use of the fiscal year data (from October to September) in the CD.

• Between 235.000 and 1.7 Million (CD and Other sources) cattle per year are imported to the USA from Canada. According to the CD, feeder/slaughter cattle represent typically more around 80% of the imported cattle from Canada; therefore, only 20% of the imported cattle have been taken into account.

• From Japan, 242 animals from a special beef breed were imported. These animals were traced, and were mostly excluded from the US rendering system. At most 39 of these animals have been rendered.

2.2 Import of MBM or MBM-containing feedstuffs from BSE-Risk countries

An overview of the data on MBM imports is presented in table 2 and is based on data provided in the country dossier (CD) and corresponding data on relevant exports as available from BSE risk countries that exported to the USA. Only data from risk periods are indicated, i.e. those periods when exports from a BSE risk country already represented an external challenge, according to the SSC opinion on the GBR (SSC, July 2000 and updated January 2002).

• The CD reports import of 5 tons of MBM from the UK. According to Eurostat, 63 tons have been exported from the UK to the USA between 1980 and 1996; however, according the updated MBM statistics from the UK (August 2001) 24 tons of MBM were exported from the UK to the USA between 1980 and 1996; 39 tons exported in 1989 were not confirmed by the updated UK export statistic and therefore not taken into account. A further 38 tons were exported in 1997-1998 and 39 tons in 1999. As it was illegal to export mammalian meat meal, bone meal and MBM from UK since 27/03/1996, exports indicated after that date should only have included non-mammalian MBM. Therefore, these imports were not taken into account.

• According to the CD, MBM was imported from Denmark, France, Italy and the Netherlands. It was claimed but not substantiated that these imports were not from ruminant origin, and therefore did not contribute to the BSE risk of the USA.

• The Eurostat export statistics indicated additional exports from Belgium, Greece, Ireland and Spain.

• Very large amounts of MBM (CD and other sources) between 18.000 and 44.000 tons annually were imported from Canada.

country imported 2038 (other sources) or 1128 (CD) live cattle from BSE risk countries other than Canada, of which 327 (other sources) or 323 (CD) came from the UK. From Canada the imports were >500,000 animals per year. The numbers shown in table 1 are the raw import figures and are not reflecting the adjusted imports for the assessment of the external challenge. Broken down to 5 year periods the resulting external challenge is as given in table 3. This assessment takes into account the different aspects discussed above that allow to assume that certain imported cattle did not enter the domestic BSE-cattle system, i.e. were not rendered into feed. In the case of the USA, all the animals for which tracing information showed that they were not rendered were excluded from the external challenge. MBM imports:

In total the country imported 689 tons MBM (CD) or 2,230 tons MBM (other sources) from BSE risk countries other than Canada, of which 5 tons (CD) or 101 tons (other sources) were exported from the UK (UK export data). From Canada, the imports were about 30 000 tons per year. The numbers shown in table 2 are the raw import figures and are not reflecting the adjusted imports for the assessment of the external challenge. Broken down to 5 year periods the resulting external challenge is as given in table 3. This assessment takes into account the different aspects discussed above that allow to assume that certain imported MBM did not enter the domestic BSE/cattle system or did not represent an external challenge for other reasons. As it was illegal to export mammalian MBM from UK since 27/03/1996, exports indicated after that date should only have included non-mammalian MBM. In the case of the USA imported MBM from UK in 1989 and between 1997 and 1999 was not taken into account.

Annex to the EFSA Scientific Report (2004) 3, 1-17 on the Assessment of the Geographical BSE Risk of USA

please see full text ;

http://www.efsa.europa.eu/en/scdocs/doc/3rax1.pdf


Scientific Report of the European Food Safety Authority on the Assessment of the Geographical BSE Risk (GBR) of the USA Question number: EFSA-Q-2003-083

Adopted: 1 July 2004

Summary (0.1 Mb)

Report (0.2 Mb)

Annex (0.3 Mb)

Summary

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

The BSE agent was probably imported into USA and could have reached domestic cattle in the middle of the eighties. These cattle imported in the mid eighties could have been rendered in the late eighties and therefore led to an internal challenge in the early nineties. It is possible that imported meat and bone meal (MBM) into the USA reached domestic cattle and leads to an internal challenge in the early nineties.

A processing risk developed in the late 80s/early 90s when cattle imports from BSE risk countries were slaughtered or died and were processed (partly) into feed, together with some imports of MBM. This risk continued to exist, and grew significantly in the mid 90’s when domestic cattle, infected by imported MBM, reached processing. Given the low stability of the system, the risk increased over the years with continued imports of cattle and MBM from BSE risk countries.

EFSA concludes that the current GBR level of USA is III, i.e. it is likely but not confirmed that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent. As long as there are no significant changes in rendering or feeding, the stability remains extremely/very unstable. Thus, the probability of cattle to be (pre-clinically or clinically) infected with the BSE-agent persistently increases.

http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1211902594180.htm




Archive Number 20101206.4364 Published Date 06-DEC-2010 Subject PRO/AH/EDR Prion disease update 2010 (11)

PRION DISEASE UPDATE 2010 (11)

SEE;

TAFS1 Position Paper on Position Paper on Relaxation of the Feed Ban in the EU Berne, 2010 TAFS

INTERNATIONAL FORUM FOR TRANSMISSIBLE ANIMAL DISEASES AND FOOD SAFETY a non-profit Swiss Foundation

http://www.promedmail.org/pls/apex/f?p=2400:1001:5492868805159684::NO::F2400_P1001_BACK_PAGE,F2400_P1001_PUB_MAIL_ID:1000,86129



Saturday, November 6, 2010

TAFS1 Position Paper on Position Paper on Relaxation of the Feed Ban in the EU Berne, 2010 TAFS

INTERNATIONAL FORUM FOR TRANSMISSIBLE ANIMAL DISEASES AND FOOD SAFETY a non-profit Swiss Foundation


http://madcowfeed.blogspot.com/2010/11/tafs1-position-paper-on-position-paper.html


http://www.aphis.usda.gov/import_export/plants/manuals/ports/downloads/apm_pdf/03_18petfoodsandfeed.pdf



http://www.dardni.gov.uk/index/animal-health/animal-diseases/bse/bse-feed-ban.htm


Saturday, August 14, 2010

BSE Case Associated with Prion Protein Gene Mutation (g-h-BSEalabama) and VPSPr PRIONPATHY

(see mad cow feed in COMMERCE IN ALABAMA...TSS)

http://prionpathy.blogspot.com/2010/08/bse-case-associated-with-prion-protein.html




Saturday, February 26, 2011

Supreme Court Protects Vaccine Manufacturers, Not Injured Children there from Bruesewitz vs Wyeth

http://vcjdtransfusion.blogspot.com/2011/02/supreme-court-protects-vaccine.html


EXPORT OF BRITISH BIOLOGICAL PHARMACEUTICALS...

snip...please see full text ;

Sunday, January 30, 2011

Vaccines and Transmissible Spongiform Encephalopathy the Prion Disease, what if ?

COMMERCIAL IN CONFIDENCE

http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/vaccines-and-transmissible-spongiform.html


The documents below were provided by Terry S. Singeltary Sr on 8 May 2000.

They are optically character read (scanned into computer) and so may contain typos and unreadable parts.

TIP740203/l 0424 CONFIDENTIAL

snip...

The responses by the companies were presented by Ms Turner and were categorised by MCA standards, the products that were discussed were all low volume usage products eg sutures, heart valves.

8. As the responses included some materials of human origin it was decided that more information should be sought about CJD. There had been 2 recent deaths reported associated with human growth hormone. These were being investigated.

snip...

http://www.mad-cow.org/00/may00_news.html#aaa


5.3.3 The greatest risk, in theory, would be from parenteral injection of material derived from bovine brain or lymphoid tissue. Medicinal products for injection or surgical implantation which are prepared from bovine tissues, or which utilise bovine serum albumin or similar agents in their manufacture, might also be capable of transmitting infectious agents. All medicinal products are licensed under the Medicines Act by the Licensing Authority following guidance, for example from the Committee on Safety of Medicines (CSM), the Committee on Dental and Surgical Materials (CDSM) and their subcommittees. The Licensing Authority have been alerted to potential concern about BSE in medicinal products and will ensure that scrutiny of source materials and manufacturing processes now takes account of BSE agent.

see all 76 pages ;

http://collections.europarchive.org/tna/20080102132706/http://www.bseinquiry.gov.uk/files/ib/ibd1/tab02.pdf



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

http://bse-atypical.blogspot.com/2010/01/14th-international-congress-on.html



Wednesday, February 3, 2010

Import Alert 62-07 Sygen Injectable (Bovine-Extracted GMI Monosialoganglioside) manufactured from bovine brain starting material

http://bseusa.blogspot.com/2010/02/import-alert-62-07-sygen-injectable.html



Monday, February 01, 2010

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

http://creutzfeldt-jakob-disease.blogspot.com/2010/02/import-alert-17-04-bse-cjd-high-risk.html



Thursday, March 19, 2009

Chronic Wasting Disease Prions in Elk Antler Velvet (Nutritional Supplements and CJD)



http://chronic-wasting-disease.blogspot.com/2009/03/chronic-wasting-disease-prions-in-elk.html



http://www.mad-cow.org/00/dec00_late_news.html#hhh


http://www.mad-cow.org/00/jan01_late.html#ggg


http://www.organicconsumers.org/meat/elkvelvet.cfm



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

http://www.fda.gov/OHRMS/DOCKETS/98fr/04n-0081-nir0001.pdf


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.

http://www.ninds.nih.gov/health_and_medical/disorders/kuru.htm


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...

http://europa.eu.int/comm/health/ph_risk/committees/sccp/documents/out229_en.pdf


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)

http://europa.eu.int/comm/food/fs/sc/ssc/out137_en.pdf


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/ -------------------


https://lists.aegee.org/cgi-bin/wa?A2=ind9911&L=BSE-L&P=R270&1=BSE-L&9=A&I=-3&J=on&X=2D25604264697D83A3&Y=flounder9%40verizon.net&d=No+Match%3BMatch%3BMatches&z=4


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 ############


https://lists.aegee.org/cgi-bin/wa?A2=ind0009&L=BSE-L&P=R2540&1=BSE-L&9=A&I=-3&J=on&X=57C86A263C194B4411&Y=flounder9%40verizon.net&d=No+Match%3BMatch%3BMatches&z=4



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.

http://bseusa.blogspot.com/2010/04/upcoming-bse-webinar-on-thursday-april.html


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.

http://www.folica.com/shampoos/haskplacenta.htm


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!

http://www.folica.com/shampoos/haskpermaid_revtre.htm


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.

http://www.beautycentury.com/mall/stockIS.asp?sku=1227


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.

http://www.ecrm-epps.com/Expose/V4_7/Table_Profiles/Alleghany.html


BSE INQUIRY

Use of Bovine offal in Cosmetics;

http://collections.europarchive.org/tna/20081105233036/http://www.bseinquiry.gov.uk/files/yb/1990/02/01004001.pdf



http://web.archive.org/web/20040625033734/www.bseinquiry.gov.uk/files/yb/1990/02/01007001.pdf


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://collections.europarchive.org/tna/20080102164040/http://www.bseinquiry.gov.uk/files/yb/1990/01/29001001.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.)

http://collections.europarchive.org/tna/20081105233038/http://www.bseinquiry.gov.uk/files/yb/1990/01/31014001.pdf



NOT FOR PUBLICATION

http://collections.europarchive.org/tna/20080102164021/http://www.bseinquiry.gov.uk/files/yb/1991/06/00005001.pdf



(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://collections.europarchive.org/tna/20080102164014/http://www.bseinquiry.gov.uk/files/yb/1991/07/25003001.pdf



http://collections.europarchive.org/tna/20081105233044/http://www.bseinquiry.gov.uk/files/yb/1991/06/26003001.pdf



http://web.archive.org/web/20030529120226/http://www.bseinquiry.gov.uk/files/yb/1991/06/30001001.pdf



http://collections.europarchive.org/tna/20080102164053/http://www.bseinquiry.gov.uk/files/yb/1991/10/15002001.pdf



http://collections.europarchive.org/tna/20080102164025/http://www.bseinquiry.gov.uk/files/yb/1991/10/31009001.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.

http://www.sesahs.nsw.gov.au/albionstcentre/infection_control/newsletter6.htm



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

http://collections.europarchive.org/tna/20080102120826/http://www.bseinquiry.gov.uk/files/sc/seac13/tab07.pdf



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.”

http://www.bse.org.uk/dfa/dfa18.htm

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.

http://www.bse.org.uk/dfa/dfa18.htm

https://lists.aegee.org/cgi-bin/wa?A2=ind0109&L=BSE-L&P=R4117&1=BSE-L&9=A&I=-3&J=on&X=57C86A263C194B4411&Y=flounder9%40verizon.net&d=No+Match%3BMatch%3BMatches&z=4



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

https://lists.aegee.org/cgi-bin/wa?A2=ind0804&L=BSE-L&P=R7115&1=BSE-L&9=A&I=-3&J=on&X=4C5F74434D94442225&Y=flounder9%40verizon.net&d=No+Match%3BMatch%3BMatches&z=4



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.

http://web.archive.org/web/20010218202403/http://www.bseinquiry.gov.uk/report/volume7/chapter8.htm#416223



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

http://web.archive.org/web/20010218200336/http://www.bseinquiry.gov.uk/report/volume7/chapteg2.htm



COSMETICS-further reading from the inquiry on this subject;

http://web.archive.org/web/20010218201247/http://www.bseinquiry.gov.uk/report/volume7/chapteg3.htm



http://web.archive.org/web/20010218201548/http://www.bseinquiry.gov.uk/report/volume7/chaptef4.htm



http://web.archive.org/web/20010624184106/http://www.bseinquiry.gov.uk/report/volume7/chapted5.htm



http://web.archive.org/web/20020328132354/http://www.bseinquiry.gov.uk/report/volume7/chapteb6.htm



http://web.archive.org/web/20010624172330/http://www.bseinquiry.gov.uk/report/volume7/chapteb7.htm



http://web.archive.org/web/20010624184940/http://www.bseinquiry.gov.uk/report/volume7/chaptea8.htm



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.

http://web.archive.org/web/20010218200025/http://www.bseinquiry.gov.uk/report/volume7/chapteri.htm



http://web.archive.org/web/20020328151016/http://www.bseinquiry.gov.uk/report/volume7/chapte10.htm



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.

http://web.archive.org/web/20030702111440/http://www.bseinquiry.gov.uk/report/volume7/chapter9.htm



http://web.archive.org/web/20020328140201/http://www.bseinquiry.gov.uk/report/volume7/chapteh2.htm



http://web.archive.org/web/20010218201146/http://www.bseinquiry.gov.uk/report/volume7/chapteh3.htm



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

http://web.archive.org/web/20010624174011/http://www.bseinquiry.gov.uk/report/volume7/chapteg4.htm



(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

http://web.archive.org/web/20010624170118/http://www.bseinquiry.gov.uk/report/volume7/chaptee5.htm



http://web.archive.org/web/20010218184950/http://www.bseinquiry.gov.uk/report/volume7/chaptec6.htm



http://web.archive.org/web/20010624181038/http://www.bseinquiry.gov.uk/report/volume7/chaptec7.htm



http://web.archive.org/web/20010624173202/http://www.bseinquiry.gov.uk/report/volume7/chapteb8.htm



http://web.archive.org/web/20030506095053/http://www.bseinquiry.gov.uk/report/volume7/chaptea9.htm



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

http://web.archive.org/web/20010218201535/http://www.bseinquiry.gov.uk/report/volume7/glossary.htm



http://web.archive.org/web/20020328150145/http://www.bseinquiry.gov.uk/report/volume7/whoswho.htm



http://web.archive.org/web/20010624175300/http://www.bseinquiry.gov.uk/report/volume7/index.htm



http://web.archive.org/web/20010221160942/http://www.bseinquiry.gov.uk/report/volume7/volume72.htm



http://web.archive.org/web/20010221160108/http://www.bseinquiry.gov.uk/report/volume7/volume73.htm



http://web.archive.org/web/20030907100258/www.bseinquiry.gov.uk/report/volume7/volume74.htm



http://web.archive.org/web/20010221160018/http://www.bseinquiry.gov.uk/report/volume7/volume75.htm



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].

http://www.bse.org.uk/witness/htm/stat115.htm


http://www.telegraph.co.uk/et?ac=003789727059657&rtmo=weoeinKb&atmo=rrrrrrrq&pg=/et/96/9/7/wbse07.html



http://www.telegraph.co.uk/et?ac=003789727059657&rtmo=weoeinKb&atmo=rrrrrrrq&pg=/et/99/11/2/nbse02.html



http://www.telegraph.co.uk/et?ac=003789727059657&rtmo=weoeinKb&atmo=rrrrrrrq&pg=/et/00/10/29/nbse129.html



Content-Type: text/plain

https://lists.aegee.org/cgi-bin/wa?A2=ind0704&L=BSE-L&P=R2765&1=BSE-L&9=A&I=-3&J=on&X=57C86A263C194B4411&Y=flounder9%40verizon.net&d=No+Match%3BMatch%3BMatches&z=4



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

http://www.mad-cow.org/00/sep00_news.html#aaa


update

http://europa.eu.int/comm/food/fs/sc/ssc/out109_en.html


http://europa.eu.int/comm/food/fs/sc/ssc/out80_en.pdf


P.S. -- one must consider 'accumulation' of agent over time. ...

2009

To date the OIE/WAHO assumes that the human and animal health standards set out in the BSE chapter for classical BSE (C-Type) applies to all forms of BSE which include the H-type and L-type atypical forms. This assumption is scientifically not completely justified and accumulating evidence suggests that this may in fact not be the case. Molecular characterization and the spatial distribution pattern of histopathologic lesions and immunohistochemistry (IHC) signals are used to identify and characterize atypical BSE. Both the L-type and H-type atypical cases display significant differences in the conformation and spatial accumulation of the disease associated prion protein (PrPSc) in brains of afflicted cattle. Transmission studies in bovine transgenic and wild type mouse models support that the atypical BSE types might be unique strains because they have different incubation times and lesion profiles when compared to C-type BSE. When L-type BSE was inoculated into ovine transgenic mice and Syrian hamster the resulting molecular fingerprint had changed, either in the first or a subsequent passage, from L-type into C-type BSE. In addition, non-human primates are specifically susceptible for atypical BSE as demonstrated by an approximately 50% shortened incubation time for L-type BSE as compared to C-type. Considering the current scientific information available, it cannot be assumed that these different BSE types pose the same human health risks as C-type BSE or that these risks are mitigated by the same protective measures.

http://www.prionetcanada.ca/detail.aspx?menu=5&dt=293380&app=93&cat1=387&tp=20&lk=no&cat2



I ask Professor Kong ;

Thursday, December 04, 2008 3:37 PM Subject: RE: re--Chronic Wating Disease (CWD) and Bovine Spongiform Encephalopathies (BSE): Public Health Risk Assessment

''IS the h-BSE more virulent than typical BSE as well, or the same as cBSE, or less virulent than cBSE? just curious.....''

Professor Kong reply ;

.....snip

''As to the H-BSE, we do not have sufficient data to say one way or another, but we have found that H-BSE can infect humans. I hope we could publish these data once the study is complete.

Thanks for your interest.''

Best regards,

Qingzhong Kong, PhD Associate Professor Department of Pathology Case Western Reserve University Cleveland, OH 44106 USA

END...TSS


P02.35

Molecular Features of the Protease-resistant Prion Protein (PrPres) in H-type BSE

Biacabe, A-G1; Jacobs, JG2; Gavier-Widén, D3; Vulin, J1; Langeveld, JPM2; Baron, TGM1 1AFSSA, France; 2CIDC-Lelystad, Netherlands; 3SVA, Sweden

Western blot analyses of PrPres accumulating in the brain of BSE-infected cattle have demonstrated 3 different molecular phenotypes regarding to the apparent molecular masses and glycoform ratios of PrPres bands. We initially described isolates (H-type BSE) essentially characterized by higher PrPres molecular mass and decreased levels of the diglycosylated PrPres band, in contrast to the classical type of BSE. This type is also distinct from another BSE phenotype named L-type BSE, or also BASE (for Bovine Amyloid Spongiform Encephalopathy), mainly characterized by a low representation of the diglycosylated PrPres band as well as a lower PrPres molecular mass. Retrospective molecular studies in France of all available BSE cases older than 8 years old and of part of the other cases identified since the beginning of the exhaustive surveillance of the disease in 20001 allowed to identify 7 H-type BSE cases, among 594 BSE cases that could be classified as classical, L- or H-type BSE. By Western blot analysis of H-type PrPres, we described a remarkable specific feature with antibodies raised against the C-terminal region of PrP that demonstrated the existence of a more C-terminal cleaved form of PrPres (named PrPres#2 ), in addition to the usual PrPres form (PrPres #1). In the unglycosylated form, PrPres #2 migrates at about 14 kDa, compared to 20 kDa for PrPres #1. The proportion of the PrPres#2 in cattle seems to by higher compared to the PrPres#1. Furthermore another PK–resistant fragment at about 7 kDa was detected by some more N-terminal antibodies and presumed to be the result of cleavages of both N- and C-terminal parts of PrP. These singular features were maintained after transmission of the disease to C57Bl/6 mice. The identification of these two additional PrPres fragments (PrPres #2 and 7kDa band) reminds features reported respectively in sporadic Creutzfeldt-Jakob disease and in Gerstmann-Sträussler-Scheinker (GSS) syndrome in humans.

http://www.neuroprion.com/pdf_docs/conferences/prion2007/abstract_book.pdf


Monday, October 19, 2009

Atypical BSE, BSE, and other human and animal TSE in North America Update October 19, 2009

http://bse-atypical.blogspot.com/2009/10/atypical-bse-bse-and-other-human-and.html


14th International Congress on Infectious Diseases H-type and L-type Atypical BSE January 2010 (special pre-congress edition)

18.173 page 189

Experimental Challenge of Cattle with H-type and L-type Atypical BSE

A. Buschmann1, U. Ziegler1, M. Keller1, R. Rogers2, B. Hills3, M.H. Groschup1. 1Friedrich-Loeffler-Institut, Greifswald-Insel Riems, Germany, 2Health Canada, Bureau of Microbial Hazards, Health Products & Food Branch, Ottawa, Canada, 3Health Canada, Transmissible Spongiform Encephalopathy Secretariat, Ottawa, Canada

Background: After the detection of two novel BSE forms designated H-type and L-type atypical BSE the question of the pathogenesis and the agent distribution of these two types in cattle was fully open. From initial studies of the brain pathology, it was already known that the anatomical distribution of L-type BSE differs from that of the classical type where the obex region in the brainstem always displays the highest PrPSc concentrations. In contrast in L-type BSE cases, the thalamus and frontal cortex regions showed the highest levels of the pathological prion protein, while the obex region was only weakly involved.

Methods:We performed intracranial inoculations of cattle (five and six per group) using 10%brainstemhomogenates of the two German H- and L-type atypical BSE isolates. The animals were inoculated under narcosis and then kept in a free-ranging stable under appropriate biosafety conditions.At least one animal per group was killed and sectioned in the preclinical stage and the remaining animals were kept until they developed clinical symptoms. The animals were examined for behavioural changes every four weeks throughout the experiment following a protocol that had been established during earlier BSE pathogenesis studies with classical BSE.

Results and Discussion: All animals of both groups developed clinical symptoms and had to be euthanized within 16 months. The clinical picture differed from that of classical BSE, as the earliest signs of illness were loss of body weight and depression. However, the animals later developed hind limb ataxia and hyperesthesia predominantly and the head. Analysis of brain samples from these animals confirmed the BSE infection and the atypical Western blot profile was maintained in all animals. Samples from these animals are now being examined in order to be able to describe the pathogenesis and agent distribution for these novel BSE types. Conclusions: A pilot study using a commercially avaialble BSE rapid test ELISA revealed an essential restriction of PrPSc to the central nervous system for both atypical BSE forms. A much more detailed analysis for PrPSc and infectivity is still ongoing.

http://www.isid.org/14th_icid/


http://ww2.isid.org/Downloads/IMED2009_AbstrAuth.pdf



http://www.isid.org/publications/ICID_Archive.shtml


14th ICID International Scientific Exchange Brochure -

Final Abstract Number: ISE.114

Session: International Scientific Exchange

Transmissible Spongiform encephalopathy (TSE) animal and human TSE in North America update October 2009

T. Singeltary

Bacliff, TX, USA

Background:

An update on atypical BSE and other TSE in North America. Please remember, the typical U.K. c-BSE, the atypical l-BSE (BASE), and h-BSE have all been documented in North America, along with the typical scrapie's, and atypical Nor-98 Scrapie, and to date, 2 different strains of CWD, and also TME. All these TSE in different species have been rendered and fed to food producing animals for humans and animals in North America (TSE in cats and dogs ?), and that the trading of these TSEs via animals and products via the USA and Canada has been immense over the years, decades.

Methods:

12 years independent research of available data

Results:

I propose that the current diagnostic criteria for human TSEs only enhances and helps the spreading of human TSE from the continued belief of the UKBSEnvCJD only theory in 2009. With all the science to date refuting it, to continue to validate this old myth, will only spread this TSE agent through a multitude of potential routes and sources i.e. consumption, medical i.e., surgical, blood, dental, endoscopy, optical, nutritional supplements, cosmetics etc.

Conclusion:

I would like to submit a review of past CJD surveillance in the USA, and the urgent need to make all human TSE in the USA a reportable disease, in every state, of every age group, and to make this mandatory immediately without further delay. The ramifications of not doing so will only allow this agent to spread further in the medical, dental, surgical arena's. Restricting the reporting of CJD and or any human TSE is NOT scientific. Iatrogenic CJD knows NO age group, TSE knows no boundaries. I propose as with Aguzzi, Asante, Collinge, Caughey, Deslys, Dormont, Gibbs, Gajdusek, Ironside, Manuelidis, Marsh, et al and many more, that the world of TSE Transmissible Spongiform Encephalopathy is far from an exact science, but there is enough proven science to date that this myth should be put to rest once and for all, and that we move forward with a new classification for human and animal TSE that would properly identify the infected species, the source species, and then the route.

http://ww2.isid.org/Downloads/14th_ICID_ISE_Abstracts.pdf


Thursday, May 26, 2011

Travel History, Hunting, and Venison Consumption Related to Prion Disease Exposure, 2006-2007 FoodNet Population Survey

Journal of the American Dietetic Association Volume 111, Issue 6 , Pages 858-863, June 2011.

http://transmissiblespongiformencephalopathy.blogspot.com/2011/05/travel-history-hunting-and-venison.html



Topics in Current Chemistry, 2011, 1-28, DOI: 10.1007/128_2011_161

Atypical Prion Diseases in Humans and Animals

Michael A. Tranulis, Sylvie L. Benestad, Thierry Baron and Hans Kretzschmar

Abstract

Although prion diseases, such as Creutzfeldt–Jakob disease (CJD) in humans and scrapie in sheep, have long been recognized, our understanding of their epidemiology and pathogenesis is still in its early stages. Progress is hampered by the lengthy incubation periods and the lack of effective ways of monitoring and characterizing these agents. Protease-resistant conformers of the prion protein (PrP), known as the “scrapie form” (PrPSc), are used as disease markers, and for taxonomic purposes, in correlation with clinical, pathological, and genetic data. In humans, prion diseases can arise sporadically (sCJD) or genetically (gCJD and others), caused by mutations in the PrP-gene (PRNP), or as a foodborne infection, with the agent of bovine spongiform encephalopathy (BSE) causing variant CJD (vCJD). Person-to-person spread of human prion disease has only been known to occur following cannibalism (kuru disease in Papua New Guinea) or through medical or surgical treatment (iatrogenic CJD, iCJD). In contrast, scrapie in small ruminants and chronic wasting disease (CWD) in cervids behave as infectious diseases within these species. Recently, however, so-called atypical forms of prion diseases have been discovered in sheep (atypical/Nor98 scrapie) and in cattle, BSE-H and BSE-L. These maladies resemble sporadic or genetic human prion diseases and might be their animal equivalents. This hypothesis also raises the significant public health question of possible epidemiological links between these diseases and their counterparts in humans.

Keywords Animal - Atypical - Atypical/Nor98 scrapie - BSE-H - BSE-L - Human - Prion disease - Prion strain - Prion type

http://resources.metapress.com/pdf-preview.axd?code=f433r34h34ugg617&size=largest



Monday, May 23, 2011

Atypical Prion Diseases in Humans and Animals 2011

Top Curr Chem (2011)

DOI: 10.1007/128_2011_161

# Springer-Verlag Berlin Heidelberg 2011

http://bse-atypical.blogspot.com/2011/05/atypical-prion-diseases-in-humans-and.html



Thursday, August 12, 2010

Seven main threats for the future linked to prions

First threat

The TSE road map defining the evolution of European policy for protection against prion diseases is based on a certain numbers of hypotheses some of which may turn out to be erroneous. In particular, a form of BSE (called atypical Bovine Spongiform Encephalopathy), recently identified by systematic testing in aged cattle without clinical signs, may be the origin of classical BSE and thus potentially constitute a reservoir, which may be impossible to eradicate if a sporadic origin is confirmed.

***Also, a link is suspected between atypical BSE and some apparently sporadic cases of Creutzfeldt-Jakob disease in humans. These atypical BSE cases constitute an unforeseen first threat that could sharply modify the European approach to prion diseases.

Second threat

snip...

http://www.neuroprion.org/en/np-neuroprion.html



http://prionpathy.blogspot.com/2010/08/seven-main-threats-for-future-linked-to.html



http://prionpathy.blogspot.com/


Rural and Regional Affairs and Transport References Committee

The possible impacts and consequences for public health, trade and agriculture of the Government’s decision to relax import restrictions on beef Final report June 2010

2.65 At its hearing on 14 May 2010, the committee heard evidence from Dr Alan Fahey who has recently submitted a thesis on the clinical neuropsychiatric, epidemiological and diagnostic features of Creutzfeldt-Jakob disease.48 Dr Fahey told the committee of his concerns regarding the lengthy incubation period for transmissible spongiform encephalopathies, the inadequacy of current tests and the limited nature of our current understanding of this group of diseases.49

2.66 Dr Fahey also told the committee that in the last two years a link has been established between forms of atypical CJD and atypical BSE. Dr Fahey said that: They now believe that those atypical BSEs overseas are in fact causing sporadic Creutzfeldt-Jakob disease. They were not sure if it was due to mad sheep disease or a different form. If you look in the textbooks it looks like this is just arising by itself. But in my research I have a summary of a document which states that there has never been any proof that sporadic Creutzfeldt-Jakob disease has arisen de novo—has arisen of itself. There is no proof of that. The recent research is that in fact it is due to atypical forms of mad cow disease which have been found across Europe, have been found in America and have been found in Asia. These atypical forms of mad cow disease typically have even longer incubation periods than the classical mad cow disease.50

http://www.aph.gov.au/senate/committee/rrat_ctte/mad_cows/report/report.pdf



Sunday, May 01, 2011

STUDY OF ATYPICAL BSE 2010 Annual Report May 2011

http://bse-atypical.blogspot.com/2011/05/study-of-atypical-bse-2010-annual.html



CREUTZFELDT JAKOB DISEASE

Saturday, March 5, 2011

MAD COW ATYPICAL CJD PRION TSE CASES WITH CLASSIFICATIONS PENDING ON THE RISE IN NORTH AMERICA

http://transmissiblespongiformencephalopathy.blogspot.com/2011/03/mad-cow-atypical-cjd-prion-tse-cases.html


Sunday, May 10, 2009

Meeting of the Transmissible Spongiform Encephalopathies Committee On June 12, 2009 (Singeltary submission)

TO : william.freas@fda.hhs.gov

May 8, 2009

Greetings again Dr. Freas, TSEAC et al,

I would kindly, once again, wish to comment at this meeting about the urgent actions that need to be taken asap, to the Meeting of the Transmissible Spongiform Encephalopathies Committee On June 12, 2009. Due to my disability from my neck injury, I will not be attending this meeting either, however I hope for my submission to be read and submitted. ...

IN reply to ;

http://tseac.blogspot.com/2009/05/meeting-of-transmissible-spongiform.html



Harvard Risk Assessment of Bovine Spongiform Encephalopathy Update, October 31, 2005 INTRODUCTION The United States Department of Agriculture's Food Safety and Inspection Service (FSIS) held a public meeting on July 25, 2006 in Washington, D.C. to present findings from the Harvard Risk Assessment of Bovine Spongiform Encephalopathy Update, October 31, 2005 (report and model located on the FSIS website: http://www.fsis.usda.gov/Science/Risk_Assessments/index.asp).

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:

http://www.fsis.usda.gov/PDF/BSE_Risk_Assess_Response_Public_Comments.pdf


From: Terry S. Singeltary Sr.

To: FREAS@CBER.FDA.GOV

Cc: william.freas@fda.hhs.gov ; rosanna.harvey@fda.hhs.gov

Sent: Friday, December 01, 2006 2:59 PM

Subject: Re: TSE advisory committee for the meeting December 15, 2006 [TSS SUBMISSION

snip...

ONE FINAL COMMENT PLEASE, (i know this is long Dr. Freas but please bear with me)

THE USA is in a most unique situation, one of unknown circumstances with human and animal TSE. THE USA has the most documented TSE in different species to date, with substrains growing in those species (BSE/BASE in cattle and CWD in deer and elk, there is evidence here with different strains), and we know that sheep scrapie has over 20 strains of the typical scrapie with atypical scrapie documented and also BSE is very likely to have passed to sheep. all of which have been rendered and fed back to animals for human and animal consumption, a frightening scenario. WE do not know the outcome, and to play with human life around the globe with the very likely TSE tainted blood from the USA, in my opinion is like playing Russian roulette, of long duration, with potential long and enduring consequences, of which once done, cannot be undone.

These are the facts as i have come to know through daily and extensive research of TSE over 9 years, since 12/14/97. I do not pretend to have all the answers, but i do know to continue to believe in the ukbsenvcjd only theory of transmission to humans of only this one strain from only this one TSE from only this one part of the globe, will only lead to further failures, and needless exposure to humans from all strains of TSE, and possibly many more needless deaths from TSE via a multitude of proven routes and sources via many studies with primates and rodents and other species. ...

Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518

snip... 48 pages...

http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064801f3413&disposition=attachment&contentType=msw8


PDF]Freas, William TSS SUBMISSION

File Format: PDF/Adobe Acrobat -

Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary

Sr. [flounder@wt.net] Monday, January 08,200l 3:03 PM freas ...

http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf


Tuesday, February 8, 2011

U.S.A. 50 STATE BSE MAD COW CONFERENCE CALL Jan. 9, 2001

http://tseac.blogspot.com/2011/02/usa-50-state-bse-mad-cow-conference.html





TSS

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