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From: TSS ()
Subject: Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material From Cattle
Date: August 15, 2007 at 7:03 am PST

[Federal Register: August 15, 2007 (Volume 72, Number 157)]
[Rules and Regulations]
[Page 45636]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15au07-6]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 700


Recordkeeping Requirements for Human Food and Cosmetics
Manufactured From, Processed With, or Otherwise Containing, Material
From Cattle

CFR Correction

In Title 21 of the Code of Federal Regulations, Parts 600 to 799,
revised as of April 1, 2007, in Sec. 700.27, on page 138, paragraph
(d) is reinstated to read as follows:


Sec. 700.27 Use of prohibited cattle materials in cosmetic products.

* * * * *
(d) Adulteration. Failure of a manufacturer or processor to operate
in compliance with the requirements of paragraph (b) or (c) of this
section renders a cosmetic adulterated under section 601(c) of the act.
[FR Doc. 07-55510 Filed 8-14-07; 8:45 am]

BILLING CODE 1505-01-D

http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/07-55510.htm


Preparation for International Cooperation on Cosmetics Regulations Meeting in Brussels, Belgium (Federal Register Notice, August 13, 2007) August 28, 2007, Rockville, MD (Registration Deadline: August 21, 2007)


http://www.cfsan.fda.gov/~lrd/fr070813.html

http://www.fda.gov/OHRMS/DOCKETS/98fr/07n-0313-nm00001.pdf


[Federal Register: October 11, 2006 (Volume 71, Number 196)]
[Rules and Regulations]
[Page 59653-59669]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11oc06-3]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 189 and 700

[Docket No. 2004N-0257]
RIN 0910-AF48

Recordkeeping Requirements for Human Food and Cosmetics
Manufactured From, Processed With, or Otherwise Containing, Material
From Cattle

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is requiring that
manufacturers and processors of human food and cosmetics that are
manufactured from, processed with, or otherwise contain, material from
cattle establish and maintain records sufficient to demonstrate that
the human food or cosmetic is not manufactured from, processed with, or
does not otherwise contain, prohibited cattle materials. These
recordkeeping requirements provide documentation for the provisions in
FDA's interim final rule entitled ``Use of Materials Derived From
Cattle in Human Food and Cosmetics.'' FDA is requiring recordkeeping
because manufacturers and processors of human food and cosmetics need
records to ensure that their products do not contain prohibited cattle
materials, and records are necessary to help FDA ensure compliance with
the requirements of the interim final rule.

DATES: This rule is effective on January 9, 2007.

FOR FURTHER INFORMATION CONTACT: Rebecca Buckner, Center for Food
Safety and Applied Nutrition (HFS-306), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1486.

SUPPLEMENTARY INFORMATION:

[[Page 59654]]

I. Background

On July 14, 2004, FDA proposed a rule entitled ``Recordkeeping
Requirements for Human Food and Cosmetics Manufactured From, Processed
With, or Otherwise Containing, Material From Cattle'' (the proposed
rule) (69 FR 42275) to require that manufacturers and processors of
human food and cosmetics that are manufactured from, processed with, or
otherwise contain, material from cattle establish and maintain records
sufficient to demonstrate the food or cosmetic is not manufactured
from, processed with, or does not otherwise contain, prohibited cattle
materials. The proposed rule was a companion rulemaking to FDA's
interim final rule (IFR) entitled ``Use of Materials Derived From
Cattle in Human Food and Cosmetics'' (the IFR) (69 FR 42256). We
believe that records sufficient to demonstrate the absence of
prohibited cattle materials in human food and cosmetics are critical
for manufacturers, processors, and FDA to ensure compliance with the
ban on prohibited cattle materials. Therefore, we are finalizing the
proposed rule to require that manufacturers and processors of human
food and cosmetics that are manufactured from, processed with, or
otherwise contain, material from cattle establish and maintain records
sufficient to demonstrate that human food and cosmetics are not
manufactured from, processed with, or do not otherwise contain,
prohibited cattle materials. We also are finalizing the provision in
the proposed rule that these records must be made available to FDA for
inspection and copying. FDA notes that the requirement in the IFR that
existing records relevant to compliance be made available to FDA
remains and has been incorporated into the final record provisions.
In response to the December 2003 finding of an adult cow--imported
from Canada--that tested positive for bovine spongiform encephalopathy
(BSE) in the State of Washington, FDA published the IFR requiring that
specified risk materials (SRMs), small intestine of all cattle, tissue
from nonambulatory disabled cattle, tissue from cattle not inspected
and passed for human consumption, and mechanically separated beef (MS
beef) not be used for FDA-regulated human food and cosmetics.\1\ SRMs
include the brain, skull, eyes, trigeminal ganglia, spinal cord,
vertebral column (excluding the vertebrae of the tail, the transverse
process of the thoracic and lumbar vertebrae, and the wings of the
sacrum), and dorsal root ganglia of cattle 30 months and older, as well
as the tonsils and distal ileum of the small intestine of all cattle.
---------------------------------------------------------------------------

\1\ In June 2005, USDA confirmed the second case of BSE in the
United States in a cow born in Texas.
---------------------------------------------------------------------------

The U.S. Department of Agriculture (USDA) also published an IFR (69
FR 1862, January 12, 2004) to prohibit certain cattle material from use
in human food. FDA's IFR extended the protection from BSE provided
under USDA's BSE IFR to FDA-regulated human food and cosmetics. On
September 7, 2005, both FDA (70 FR 53063) and USDA (70 FR 53043)
published amendments to their respective IFRs to allow the use of small
intestine in human food and cosmetics provided the distal ileum has
been removed. This final rule on recordkeeping will help ensure
compliance with the provisions of FDA's IFR and, thereby, will serve as
an additional safeguard to reduce human exposure to the agent that
causes BSE that may be present in human food and cosmetics that are
manufactured from, processed with, or otherwise contain, material from
cattle.
FDA believes that these recordkeeping requirements are necessary
for manufacturers and processors to ensure that all cattle material
they use is free from prohibited cattle materials. Furthermore, these
requirements are necessary for FDA to ensure compliance with the
provisions of the IFR. There is currently no validated premortem test
to reliably detect the presence of the BSE agent or the presence of
prohibited cattle material in human food and cosmetics. Once cattle
material such as brain or spinal cord is separated from the source
animal, it may not be possible to determine the age of the animal from
which the material came without records and, therefore, whether the
material is an SRM. In addition, without records, it may not be
possible to determine whether a product contains material from cattle
that were not inspected and passed for human consumption. Also, a
product might contain MS beef without its presence being evident from
the appearance of the product.
FDA received 32 responses, each containing one or more comments,
from industry, consumers, and other stakeholder groups in response to
the proposed rule. We have responded in this document to the comments
that were within the scope of this rulemaking. We received several
comments that pertained to the prohibitions on the cattle materials
themselves, as opposed to the recordkeeping requirements, and other
issues that are covered in the IFR. We will be responding to those
comments when we finalize the IFR.

II. Response to Comments

A. Who Has to Keep Records? (Sec. Sec. 189.5(c)(1) and 700.27(c)(1)
(21 CFR 189.5(c)(1) and 700.27(c)(1)))


SNIP...FULL TEXT @ ;


http://www.cfsan.fda.gov/~lrd/fr061011.html


§ 700.27 Use of prohibited cattle materials in cosmetic products.
top
(a) Definitions . The definitions and interpretations of terms contained in section 201 of the Federal Food, Drug, and Cosmetic Act (the act) apply to such terms when used in this part. The following definitions also apply:

(1) Prohibited cattle materials means specified risk materials, small intestine of all cattle except as provided in paragraph (b)(2) of this section, material from nonambulatory disabled cattle, material from cattle not inspected and passed, or Mechanically Separated (MS)(Beef). Prohibited cattle materials do not include tallow that contains no more than 0.15 percent insoluble impurities, tallow derivatives, hides and hide-derived products, and milk and milk products.

(2) Inspected and passed means that the product has been inspected and passed for human consumption by the appropriate regulatory authority, and at the time it was inspected and passed, it was found to be not adulterated.

(3) Mechanically Separated (MS)(Beef) means a meat food product that is finely comminuted, resulting from the mechanical separation and removal of most of the bone from attached skeletal muscle of cattle carcasses and parts of carcasses that meet the specifications contained in 9 CFR 319.5, the regulation that prescribes the standard of identity for MS (Species).

(4) Nonambulatory disabled cattle means cattle that cannot rise from a recumbent position or that cannot walk, including, but not limited to, those with broken appendages, severed tendons or ligaments, nerve paralysis, fractured vertebral column, or metabolic conditions.

(5) Specified risk material means the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months and older and the tonsils and distal ileum of the small intestine of all cattle.

(6) Tallow means the rendered fat of cattle obtained by pressing or by applying any other extraction process to tissues derived directly from discrete adipose tissue masses or to other carcass parts and tissues. Tallow must be produced from tissues that are not prohibited cattle materials or must contain not more than 0.15 percent insoluble impurities as determined by the method entitled “Insoluble Impurities” (AOCS Official Method Ca 3a-46), American Oil Chemists' Society (AOCS), 5th Edition, 1997, incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or another method equivalent in accuracy, precision, and sensitivity to AOCS Official Method Ca 3a-46. You may obtain copies of the method from the AOCS ( http://www.aocs.org ) 2211 W. Bradley Ave. Champaign, IL 61821. Copies may be examined at the Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html .

(7) Tallow derivative means any chemical obtained through initial hydrolysis, saponification, or trans-esterification of tallow; chemical conversion of material obtained by hydrolysis, saponification, or trans-esterification may be applied to obtain the desired product.

(b) Requirements . (1) No cosmetic shall be manufactured from, processed with, or otherwise contain, prohibited cattle materials.

(2) The small intestine is not considered prohibited cattle material if the distal ileum is removed by a procedure that removes at least 80 inches of the uncoiled and trimmed small intestine, as measured from the caeco-colic junction and progressing proximally towards the jejunum, or by a procedure that the establishment can demonstrate is equally effective in ensuring complete removal of the distal ileum.

(c) Records. (1) Manufacturers and processors of a cosmetic that is manufactured from, processed with, or otherwise contains, material from cattle must establish and maintain records sufficient to demonstrate that the cosmetic is not manufactured from, processed with, or does not otherwise contain, prohibited cattle materials.

(2) Records must be retained for 2 years after the date they were created.

(3) Records must be retained at the manufacturing or processing establishment or at a reasonably accessible location.

(4) The maintenance of electronic records is acceptable. Electronic records are considered to be reasonably accessible if they are accessible from an onsite location.

(5) Records required by this section and existing records relevant to compliance with this section must be available to FDA for inspection and copying.

(6) When filing entry with U.S. Customs and Border Protection, the importer of record of a cosmetic manufactured from, processed with, or otherwise containing, cattle material must affirm that the cosmetic was manufactured from, processed with, or otherwise contains, cattle material and must affirm that the cosmetic was manufactured in accordance with this section. If a cosmetic is manufactured from, processed with, or otherwise contains, cattle material, then the importer of record must, if requested, provide within 5 days records sufficient to demonstrate that the cosmetic is not manufactured from, processed with, or does not otherwise contain, prohibited cattle material.

(7) Records established or maintained to satisfy the requirements of this subpart that meet the definition of electronic records in §11.3(b)(6) of this chapter are exempt from the requirements of part 11 of this chapter. Records that satisfy the requirements of this subpart but that are also required under other applicable statutory provisions or regulations remain subject to part 11 of this chapter.

[70 FR 53068, Sept. 7, 2005, as amended at 71 FR 59668, Oct. 11, 2006 ]


http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr;sid=4d62e23c377ad7edc6751cd6d20598c9;rgn=div5;view=text;node=21%3A7.0.1.2.10;idno=21;cc=ecfr#21:7.0.1.2.10.2.1.10

Voluntary Report - public distribution

Date: 3/27/2007

GAIN Report Number: CH7025

CH7025

China, Peoples Republic of

Livestock and Products

China Proposes to Ease Certification Requirements

for Cosmetics Imports

2007

Approved by:

Maurice House

U.S. Embassy

Prepared by:

Casey Bean and Zhang Jianping

Report Highlights:

On February 21, 2007, the Chinese WTO TBT Enquiry Point notified to the World Trade

Organization (WTO) of a proposed policy change on the certification of imported cosmetics

from countries with BSE. The new policy will become effective on August 1, 2007. This

announcement is positive news for the U.S. cosmetics industry since they will no longer be

required to submit a CTFA certificate with shipments to China. China's demand for imported

cosmetics remains strong, and the country's imports increased by 40 and 84 percent

respectively in volume and value in January 2007 over the same month of the previous year.

Attached is an unofficial translation of China's WTO notification.

Includes PSD Changes: No

Includes Trade Matrix: No

Unscheduled Report

Beijing [CH1]

[CH]

USDA Foreign Agricultural Service

GAIN Report

Global Agriculture Information Network

Template Version 2.09

GAIN Report - CH7025 Page 2 of 4

UNCLASSIFIED USDA Foreign Agricultural Service

Executive Summary

On February 21, 2007, the Chinese World Trade Organization (WTO) Enquiry Office at the

General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) notified to

the WTO of a draft policy change on cosmetics imports from countries with bovine

spongiform encephalopathy (BSE). The new policy will become effective on August 31,

2007.

According to the new policy, Chinese importers will be no longer requested to provide the

Cosmetic Certificate for BSE issued by the health administrative department, or officially

authorized agencies in BSE countries, including the United States, when they apply for health

permits with the Ministry of Health (MOH) or declare for import inspection and quarantine

with the Chinese entry-exit inspection and quarantine bureaus under AQSIQ. MOH and

AQSIQ have jointly listed forbidden high-risk materials in cosmetics from BSE-infected

countries for manufacturers in those countries. (Please refer to the unofficial translation of

China’s WTO notification below.)

This announcement is positive news for U.S. suppliers since they are no longer required to

submit the BSE certificate issued by the Cosmetic, Toiletry and Fragrance Association (CTFA).

During 2004, in order to maintain market access for U.S. cosmetics in the wake of the

December 2003 detection of BSE in the United States, FAS Beijing helped broker this interim

certification requirement through CTFA.

China’s demand for imported cosmetics remains strong—imports in January 2007

increased by 40 and 84 percent, respectively, in volume and value from the year

before

As China’s living standard and disposable incomes continue rising, so does consume r demand

for imported cosmetics. China’s total cosmetics imports in 2006 increased by 62 percent to

12,988 MT from 8,019 MT in 2004, and China’s total import volume in the first month in

2007 increased by 40 percent over the same month in 2006. China’s total import value for

cosmetics in 2006 reached $276.5 million, a 94 percent increase from $142.8 million in

2004. China’s total import value in the first month in 2007 increased by 84 percent

compared with the same month in 2006. The United States is the second largest supplier to

China after France, accounting for 26 and 21 percent respectively in China’s total import

volume and value in 2006.

FAS Beijing believes this new policy will facilitate imports of cosmetics imports.

Table 1: China cosmetics imports in volume

China Cosmetics Imports, 2004-2007 (MT)

Jan-Dec Jan-Dec Jan-Dec Jan - Jan Jan - Jan

Quantity Quantity Quantity Quantity

Comparison

% Change

Origin 2004 2005 2006 2006 2007 2007/06

World 8,019 10,515 12,988 779 1,092 40.18

France 2,163 2,752 3,506 159 319 100.63

United States 2,045 2,974 3,332 98 294 200.00

Japan 980 1,369 1,543 90 132 46.67

South Korea 276 675 1,038 131 102 -22.14

United Kingdom 250 315 470 23 52 126.09

Taiwan 1,025 861 902 71 49 -30.99

GAIN Report - CH7025 Page 3 of 4

UNCLASSIFIED USDA Foreign Agricultural Service

Australia 50 53 63 3 36 1100.00

Monaco 120 230 303 12 18 50.00

Other 1,110 1,286 1,831 192 90 -53.13

HS Code: 3303.0000, 3304.1000, 3304.2000, 3304.3000, 3304.9010 and 3304.9900

Source: WTA China Statistics

Table 2: China cosmetics imports in value

China Cosmetics Imports, 2004-2007 ($1,000))

Jan-Dec Jan-Dec Jan-Dec Jan - Jan Jan - Jan

Value Value Value Value

Comparison

% Change

Origin 2004 2005 2006 2006 2007 2007/06

World 142,754 210,032 276,452 15,118 27,787 83.80

France 50,774 66,992 97,562 4,765 10,696 124.47

United States 27,204 50,251 58,288 2,083 5,493 163.71

Japan 29,756 43,689 50,884 3,371 5,023 49.01

South Korea 3,562 11,388 15,600 1,832 1,799 -1.80

United Kingdom 591 545 10,458 676 1,155 70.86

Taiwan 4,132 4,384 5,733 528 388 -26.52

Australia 332 316 545 30 97 223.33

Monaco 3,707 6,856 6,917 247 606 145.34

Other 22,696 25,611 30,465 1,586 2,530 59.52

HS Code: 3303.0000, 3304.1000, 3304.2000, 3304.3000, 3304.9010 and 3304.9900

Source: WTA China Statistics

Translation of China’s draft policy change notified to the WTO

(Unofficial Translation, FAS Beijing)

Notification on Modifying the Management Measure For

Cosmetics Imported From BSE-Infected Areas

(Draft)

(February 21, 2007)

To further strengthen the management on cosmetics imports, the measure on imported

cosmetics from BSE-infected areas will be adjusted as follows.

I. It is forbidden to import cosmetics with high-risk materials from BSE-infected

areas as listed in the appendix of this notification. The Ministry of Health (MOH)

and the General Administration of Quality Supervision, Inspection and Quarantine

(AQSIQ) will revise and announce the list of high-risk materials based on risk

assessments result.

II. Importers will be no longer requested to provide the Cosmetics Certificate for BSE

issued by the health administrative department or officially authorized agencies in

BSE countries when applying for a health permit (or recorded certificate) with the

health administrative department or declaring for inspection and quarantine with

the entry-exit inspection and quarantine authorities, which are under the State

Council.

GAIN Report - CH7025 Page 4 of 4

UNCLASSIFIED USDA Foreign Agricultural Service

III. Imported cosmetics with high-risk materials listed in the Appendix from BSEinfected

areas will be dealt with based on Chinese laws and regulations.

This notification will become effective on August 31, 2007

Appendix:

Forbidden High-Risk Materials in Imported Cosmetics from BSE-Infected Areas

1. Bovine and ovine brain, spinal cord, skull, vertebral column, eyes, tonsils, intestines,

cerebrospinal fluid, pituitary, duramater spinalis, pineal, spleen, thymus and other

lymph tissues, blood, umbilical cord, ovaries, placenta, tongue, livers, adrenal glands,

pancreas, etc., as well as their products.

2. Gelatin or collagen derived from bovine or ovine bones without high pressure washing

(fat skimming)—softening through acid washing—acid or alkaline treatment—

filtration—sterilization with temperature at or above 138 degrees of centigrade no less

than 4 seconds.

End report


http://www.fas.usda.gov/gainfiles/200703/146280618.pdf


snip...


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


snip...


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://www.bseinquiry.gov.uk/report/volume7/chapter9.htm

http://www.bseinquiry.gov.uk/report/volume7/chapteh2.htm

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://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://www.bseinquiry.gov.uk/report/volume7/chaptee5.htm

http://www.bseinquiry.gov.uk/report/volume7/chaptec6.htm

http://www.bseinquiry.gov.uk/report/volume7/chaptec7.htm

http://www.bseinquiry.gov.uk/report/volume7/chapteb8.htm

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://www.bseinquiry.gov.uk/report/volume7/glossary.htm


http://www.bseinquiry.gov.uk/report/volume7/whoswho.htm


http://www.bseinquiry.gov.uk/report/volume7/index.htm


http://www.bseinquiry.gov.uk/report/volume7/volume72.htm

http://www.bseinquiry.gov.uk/report/volume7/volume73.htm


http://www.bseinquiry.gov.uk/report/volume7/volume74.htm


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

FULL TEXT COSMETICS AND BSE, BASE ETC. @ ;

http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0704&L=sanet-mg&P=71

RA- 07

CLUSTERING OF PRPPRES IN CENTRAL BRAIN REGIONS OF BSE-INFECTED MACAQUES
(M. FASCICULARIS)

J.Montag1, G.Hunsmann1, W.Schulz-Schaefer2, and D.Motzkus1
1German Primate Center (DPZ), Dept. of Virology and Immunology, Kellnerweg
4, 37077 Göttingen, Germany
2Georg-August University Göttingen, Dept. of Neurology, Robert-Koch-Str. 40,
37075 Göttingen, Germany

According to biochemical and epidemiological findings bovine spongiform
encephalopathy (BSE) was transmitted
to humans causing variant Creutzfeldt Jakob disease (vCJD). Previous studies
have shown intracerebral (i.c.)
transmission of BSE affected brain from cattle can cause TSEs in cynomolgus
macaques (M. fascicularis). The
lesion profile resembles that of vCJD. Recently, oral infection of M.
fascicularis with macaque-adapted BSE
material was reported.
In cooperation with five European partners a quantitative study for the
transmission of the BSE agent to M.
fascicularis was initiated to assess the risk of vCJD infection in humans
through contaminated food products.
Titration was performed orally and intracerebrally to determine the minimal
infectious dose for cynomolgus
monkeys.

Here we report the outcome of the intracerebral infection with 50 mg BSE
brain homogenate in six non-human
primates. All animals showed clinical symptoms of TSE after an average of
1100 days. Using immunohistological
and biochemical methods prion protein (PrP) deposits were confirmed in the
brains of all animals. Using Western
blot analysis the glycosylation pattern was compared to the inoculum and to
the pattern of different CJD
subtypes. The glycopattern TSE infected cynomolgus macaques resembles human
CJD type 2. Simian PrPres
was detected with the monoclonal anti prion antibody 11C6, which revealed a
higher sensitivity in comparison to
12F10 and 3F4. We further analysed the distribution of PrPres by
microdissection of seven different brain regions
of all infected macaques. High concentrations of PrPres were found in
central brain regions, as gyrus cinguli,
nucleus caudatus, vermis cerebelli and basis pontis. In contrast, in the
peripheral regions gyrus frontalis, gyrus
parietalis and gyrus occipitalis PrPres was hardly detectable.
Thus, the incubation period related to the life expectancy, the PrPres
glycosylation pattern as well as the
distribution in certain brain regions resemble those in vCJD patients. The
relative abundance of PrPres in
macaques will be compared to that of orally infected animals.


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


PR-18
STUDIES ON THE SECOND ATYPICAL BSE CASE IN A JAPANESE BLACK COW

K. Hagiwara1, Y. Nakamura1, Y. Yamakawa1, Y. Sato2, M. Tobiume2, T. Sata2
and the Expert Committee for
BSE Diagnosis, Ministry of Health, Labour and Welfare (MHLW) 3
Dep. Biochemistry and Cell Biology1 and Pathology2, Natl. Inst. Infectious
Diseases, Shinjuku, Tokyo 162-8640,
Japan, and MHLW, Tokyo 100-8916, Japan 3

An ELISA (Plateria, BioRad) positive specimen of a 14 year-old Japanese
Black cow (beef cattle)
slaughtered in an abattoir was examined by western-blot (WB) and
histological/immunohistochemical
(IHC) analyses for the confirmation of BSE. Dysstasia had been reported as a
clinical symptom.
Histological examination of the medulla oblongata at the level of obex
showed severe vacuolations in
dorsal nucleus of the vagus, nucleus of the solitary tract and nucleus of
the spinal tract. Granular and
linear deposition of PrPSc was also detected in these areas by IHC analysis.
Thus, histological and
IHC data were compatible with the histopathology of the typical BSE. In the
WB analysis, however,
the amount of the di-glycosylated PK-resitant PrPP
Sc was found to be at approx.35% of the total PrPSc,
and the mono-glycosylated PrPSc was at approx.40%. The WB analyses showed
that PrPSc
distributed widely in the brain with the unchanged glycosylation ratio. Such
a glycosylation-ratio is
distinct from that of the typical BSE agent in which the di-glycosylated
form is dominant (approx.70%)
but, intriguingly, similar to that of the type-2 sporadic CJD agent. No DNA
mutation was detected in
the PrP coding region, except polymorphisms of the codons for Gln78 and
Asn192 being determined
as CAG and AAT, respectively. Judging from the glycosylation-ratio, BSE
prion herein is different
from the typical BSE prion, and the atypical BSE prion found previously in a
Holstein steer in Japan
(ref. 1). Instead, its molecular feature is close, if not identical, to
PrPSc found in the cattle succumbed
to bovine amyloidtic spongiform encephalopathy (ref. 2), and to the sporadic
CJD-like PrPSc in the
mice inoculated with BSE agent (ref. 3).
References: 1) Y. Yamakawa et.al., Jpn.J.Infect.Dis. (2003), 56, 221. 2) C.
Casalone et.al., PNAS (2004), 101, 3065. 3) S.E.
Lloyd et.al., J.Gen.Virol. (2004), 85, 2471.


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http://www.neuroprion.com/pdf_docs/conferences/prion2006/abstract_book.pdf

PATH-26

Pathological Prion Protein in Muscles of Rodents Infected with BSE or vCJD

Achim Thomzig1, Franco Cardone2, Dominique Krüger1, Maurizio Pocchiari2,
Paul Brown3,
Michael Beekes1
1 Robert Koch-Institut, P24; 2 Instituto Superiore di Sanitŕ, Depatment of
Cell Biology and Neurosciences, Rome, Italy;
3 Bethesda, Maryland, USA

Recently, pathological prion protein PrPTSE was detected in muscles from
sheep infected with
scrapie, the archetype of transmissible spongiform encephalopathies (TSEs).
This finding has
highlighted the question of whether mammalian muscle may potentially also
provide a reservoir
for TSE agents related to Bovine Spongiform Encephalopathy (BSE) and variant
Creutzfeldt-
Jakob Disease (vCJD). We here report results from studies in hamsters and
mice which provide
direct experimental evidence, for the first time, of BSE- and
vCJD-associated PrPTSE deposition
in muscles. Our findings emphasize the need for further assessment of
possible public health
risks from TSE involvement of skeletal muscle.


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http://www.neuroprion.com/pdf_docs/conferences/prion2005/abstract_book.pdf


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