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From: TSS ()
Subject: Docket No. 2005N-0373 RIN number 0910-AF54 TSS SUBMISSION
Date: January 25, 2007 at 8:35 am PST

----- Original Message -----
From: Terry S. Singeltary Sr.
Cc: ; ;
Sent: Wednesday, January 24, 2007 5:40 PM
Subject: Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants; Proposed Rule Docket No. 2005N-0373 RIN # 0910-AF54


A kind greetings from Texas. I tried submitting this twice, and was not sure either time if it was recieved and downloaded correctly. so i send this to you in case it did not...........many thanks, terry

Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants; Proposed Rule Docket No. 2005N-0373 RIN # 0910-AF54


Docket No. 2005N-0373
and RIN number 0910-AF54

[Federal Register: January 12, 2007 (Volume 72, Number 8)]
[Proposed Rules]
[Page 1581-1619]

Docket No. 2005N-0373
and RIN number 0910-AF54

Use of Materials Derived from Cattle in Medical Products Intended for
Use in Humans and Drugs Intended for Use in Ruminants; Proposed Rule


SUMMARY: The Food and Drug Administration (FDA) is proposing to
prohibit the use of certain cattle material in, or in the manufacture
(including processing) of, drugs, biologics, and medical devices
intended for use in humans and human cells, tissues, and cellular and
tissue-based products (HCT/Ps) (collectively, medical products for
humans), and in drugs intended for use in ruminant animals (drugs for
ruminants). FDA is also proposing new recordkeeping requirements for
medical products for humans and drugs for ruminants that are
manufactured from or otherwise contain material from cattle. FDA is
proposing these actions as part of its continuing efforts to strengthen
defenses against the potential risk of exposure to, and spread of,
bovine spongiform encephalopathy (BSE) and related human disease in the
United States.

DATES: Submit written or electronic comments on the proposed rule by
March 13, 2007. Submit written comments on the information collection
requirements by February 12, 2007. Requests for an informal hearing on
the proposed ban related to medical devices must be submitted by
February 12, 2007.

ADDRESSES: You may submit comments, identified by Docket No. 2005N-0373
and RIN number 0910-AF54, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following ways:
Federal eRulemaking Portal:

Follow the instructions for submitting comments.
Agency Web site:



Docket No. 2005N-0373
and RIN number 0910-AF54

Greetings FDA et al,
ONCE again I would kindly like to comment on the continuous failed attempts
by the FDA to regulate the use of certain cattle material in, or in the manufacture
including processing) of, drugs, biologics, and medical devices
intended for use in humans and human cells, tissues, and cellular and
tissue-based products (HCT/Ps) (collectively, medical products for
humans), and in drugs intended for use in ruminant animals (drugs for
ruminants) from the proven risk factors of Transmissible Spongiform Encephalopahy
i.e. TSE's in all species. I have continued to warn the FDA et al about these
risk factors via the surgical and medical arena (vaccines, nutritional supplements,
bovine heart valves, and other animal donor tissue), and I have continued to point
out the risk factor of the UKBSENVCJD only theory, and the ramifications there from,
i.e. BASE (bovine amyloidotic spongiform encephalopathy), and my greatest fears, one
I have warned you about time and time again, seems to be coming true ;

64. A member noted that at the recent Neuroprion meeting, a study was
presented showing that in transgenic mice BSE passaged in sheep may be more
virulent and infectious to a wider range of species than bovine derived BSE.
Other work presented suggested that BSE and bovine amyloidotic spongiform
encephalopathy (BASE) MAY BE RELATED. A mutation had been identified in the
MUTATION FOUND IN CASES OF SPORADIC CJD. A study also demonstrated that in a
mouse model it was possible to alleviate the pathological changes of prion
disease by suppressing expression of the prion protein gene after infection.

3:00 Afternoon Refreshment Break, Poster and Exhibit Viewing in the Exhibit

3:30 Transmission of the Italian Atypical BSE (BASE) in Humanized Mouse

Models Qingzhong Kong, Ph.D., Assistant Professor, Pathology, Case Western Reserve

Bovine Amyloid Spongiform Encephalopathy (BASE) is an atypical BSE strain
discovered recently in Italy, and similar or different atypical BSE cases
were also reported in other countries. The infectivity and phenotypes of
these atypical BSE strains in humans are unknown. In collaboration with
Pierluigi Gambetti, as well as Maria Caramelli and her co-workers, we have
inoculated transgenic mice expressing human prion protein with brain
homogenates from BASE or BSE infected cattle. Our data shows that about half
of the BASE-inoculated mice became infected with an average incubation time
of about 19 months; in contrast, none of the BSE-inoculated mice appear to
be infected after more than 2 years. ***These results indicate that BASE is
transmissible to humans and suggest that BASE is more virulent than
classical BSE in humans.

6:30 Close of Day One

Volume 12, Number 12–December 2006


On the Question of Sporadic or Atypical Bovine Spongiform Encephalopathy and

Creutzfeldt-Jakob Disease

1997 TO 2006. SPORADIC CJD CASES TRIPLED, with phenotype
of 'UNKNOWN' strain growing. ...

There is a growing number of human CJD cases, and they were presented last
week in San Francisco by Luigi Gambatti(?) from his CJD surveillance

He estimates that it may be up to 14 or 15 persons which display selectively
SPRPSC and practically no detected RPRPSC proteins.

Disturbingly, we now know that the USA has had, beyond any shadow of a doubt, been
circulating TSE in a very wide variety of products, and have been for decades. Even
more disturbingly, we now have to deal with, whether or not the industry like it or not,
atypical TSE i.e. BASE in the USA. NOW we have the 4th documented vCJD transfusion related
case in the U.K., this raises serious questions about blood and tissue related products in
relations to TSE transmission from all species ;

Date: January 18, 2007 at 8:32 am PST

Fourth case of transfusion-associated vCJD infection in the United Kingdom

Editorial team (, Eurosurveillance editorial office

A suspected case of variant Creutzfeldt-Jakob disease (vCJD) has recently been diagnosed
in a patient in the United Kingdom (UK), who received a blood transfusion from a donor who
later developed vCJD [1]. This is the fourth case of probable transfusion transmission of
vCJD infection in the UK. Three of the four recipients developed symptoms of vCJD.
The first symptomatic case of vCJD associated with blood transfusion was identified in
December 2003. This individual developed vCJD six and a half years after transfusion of
red cells donated by an individual who developed symptoms of vCJD three and a half years
after donation.

A second case of vCJD 'infection' was identified a few months later in a person who had
received red cells from a donor who developed symptoms of vCJD 18 months after donation.
This patient (the second case) died from causes unrelated to vCJD five years after
transfusion. Post-mortem investigations found abnormal prion protein in the spleen
and a cervical lymph node., However, prion protein was not found in the brain, and no
pathological features of vCJD were found.

A third case developed symptoms of vCJD six years after receiving a transfusion of red
blood cells, and died two years and eight months later. The donor of the blood involved
developed vCJD about 20 months after donating it.

These three cases have been published as case reports and in the findings of the ongoing
collaborative study between the National Blood Services, the National CJD Surveillance Unit,
and the Office for National Statistics. This study aims to collect evidence about transmission
of CJD or vCJD via the blood supply [2,3,4,5].

The new, fourth case is in a patient who developed symptoms of vCJD eight and a half years
after receiving a transfusion of red blood cells from a donor who developed vCJD about 17
months after this blood was donated [1]. The donor to this case also donated the vCJD-implicated
blood transfused to the third case. As for all other reported clinical vCJD cases that have been
tested for genotype, this patient is a methionine homozygote at codon 129 of the prion protein gene.
The patient is currently alive.

All four cases had received transfusions of non-leucodepleted red blood cells between 1996 and 1999.
Since October 1999, leucocytes have been removed from all blood used for transfusion in the UK. The
effect of leucodepletion on the reduction of the risk of transmission of vCJD from an infective
donation is uncertain.

This fourth case of vCJD infection associated with blood transfusion further increases the level of
concern about the risk of vCJD transmission between humans by blood transfusion, although much
remains unknown. This reinforces the importance of the existing precautions that have been introduced
to reduce the risk of transmission of vCJD infection by blood and blood products [6]. No cases of
vCJD have been associated with fractionated plasma products. The small group of living recipients
of vCJD-implicated blood transfusion in the UK have been informed of their potential exposure to
vCJD by blood transfusion, asked to take certain precautions to reduce the risk of onward
person-to-person transmission of vCJD during health care, and offered specialist neurological
evaluation and advice.

This article has been adapted from reference 1




HPA Press Statement
18 January 2007
4th case of variant CJD infection associated with blood transfusion

ONCE again I must warn you that 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 and tissue from
the USA bovine, 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 tried
to warn back in 2001, at the infamous Jan. 9, 2001 50 STATE BSE CONFERENCE CALL that the USA indeed
was still feeding ruminant protein to 'tissue and blood donor herds', to no avail.

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. ...

WE have known about risk factors of Scrapie Associated Fibers i.e. SAFs and ignored
the '1968 MEDICINE ACT' ;

The BSE Inquiry / Statement No 477
Professor Sir James Armour
Issued 07/07/1999



Although the letter from the BSE Inquiry requesting evidence was addressed to me, I have
presented the course of events as handled by the VPC under my chairmanship. There was very
good agreement between the Committee and myself on the advice given to the Medicines Unit,
VMD and the Licensing Authority. Advice given through 1988 and 1989 centred on the
development of Guidelines, both UK and European, in relation to the source and tissues of origin
of materials used in the manufacture of veterinary products (and their sterilisation).

Answers to Specific Considerations

Outlined in Annex B of BSE Inquiry Letter of 7th April 1999

1. The interaction which you and/or the Committee of which you were a member had
with the Department of Health and the various bodies constituted to advise it
(Medicines Control Agency, Committee for Safety of Medicines, the Biologicals Sub-
Committee, the Safety, Efficacy and Adverse Reactions Committee and the BSE
Working Group). In particular, to what extent were information and ideas shared?
Who instigated such action, in what forum did it take place and how was it
structured? What was the outcome?

The only formal interaction that I or other members of the VPC had with DoH was
through the representatives of DoH who attended VPC meetings. Any information from
the other committees mentioned came via officials of MAFF, CVL or VMD, who had
attended meetings of the Biological Sub-Committee of CSM and the BSE Working

2. The information and knowledge which was in the possession of the committee of
which you were a member regarding bovine and ovine materials in veterinary
medicines prior to the identification of BSE in cattle.

Information was contained in individual licence applications granted after the 1968 Act
[L12 Part A].

3. The approach subsequently taken to gathering, collating and analysing information
as to the bovine and ovine ingredients in veterinary medical products.

Following the issue of the 1989 Guidelines on Spongiform Encephalopathies of Bovine,
Ovine and Caprine Origin: Guidance on Good Manufacturing Practice and Request for
Information [YB89/3.15/4.1-4.4], these were rigorously applied by the VPC to all new
applications seen and to the products seen under the review of products licensed prior to
Following collation and analysis of the returns on the questionnaires issued by VMD in
March 1989, existing products were treated in the same way.

4. The formulation of the joint Committee for the Safety of Medicines/Veterinary
Products Committee Guidelines for Industry issued in March 1989 and of any
revision of these guidelines.

These guidelines were originally drafted by officials at the Medicines Unit, CVL and
their counterparts at the Department of Health.
They were then considered by the CSM and the VPC at individual meetings and, with a
few suggested amendments, approved.
These were superseded by CVMP Guidelines first published in January 1993

5. The procedures adopted and action taken to ensure compliance with those
guidelines. In particular, what policy was adopted with regard to manufacturers’
existing stocks of medicinal products which contained bovine ingredients and what
information was gathered as to manufacturers’ compliance with that policy? What
structures were adopted for ensuring compliance in general?
Compliance was handled by VMD. The VPC received reports where there was a potential
problem with compliance and advice was offered (see [YB90/11.00/5.1-5.2] and (Annex

6. The policy adopted in relation to the licensing of veterinary medicines and the
changes in that policy over the relevant period.

The main changes relate to those recommended in the 1989 Guidelines [YB89/3.15/4.1-
4.4] and those produced by the CVMP in 1993 [YB93/1.00/4.1-4.6]. The source and
origins of tissue material used in veterinary medicines, in particular bovine material,
became key quality and safety issues.

7. Research undertaken or investigations made in order to assess the risk to cattle
and/or other animals and/or humans from the use of medicines (veterinary or
otherwise) containing bovine material. In particular, what assessment was made of
the risks associated with different routes of infectivity?

Neither I nor, to my knowledge any VPC member, recommended any particular research
in relation to BSE/veterinary medicines.
Risks associated with different routes of infectivity were dealt with on a product-byproduct
application basis. I and the VPC members were aware of the order of infectivity
identified for scrapie from previous studies and emphasised in the CVMP guidelines of
1993. This was based on a titration of infectivity in mice by the intracerebral route.

8. What consideration if any was given to the risk associated with: (a) the use of bovine
pituitary hormones, both to stimulate ovulation in cattle and otherwise and (b) the
use of ovine materials in veterinary medicines, both in the period before and after
the identification of BSE in cattle?

a. The VPC considered possible contamination of medicines with the BSE agent in July
1988 while assessing guidelines for the review of products containing hormones at the
request of the Medicines Unit. The need for any risk of contamination with BSE to be
considered with substances derived from glandular extracts intended for use in the
treatment of ruminants was highlighted during the discussions concerning hormonal
products in 1988 already referred to (See Paragraph 6 – Chronology of the BSE
discussions at VPC). This discussion included bovine pituitary hormones.
b. The need to avoid the use of ovine brain material, or indeed, any ovine material with the
potential to contaminate medicines with the scrapie agent is dealt with under MAL67 -
MAFF’s 1983 guide to the use of substances of animal origin in the manufacture of
veterinary vaccines [YB83/6.00/1.1-1.4]. As mentioned previously, risk was assessed
with individual product applications. The Committee and I were aware that scrapie had
been disseminated via a louping ill vaccine (I think in the late 1940s or early 1950s) in
which brain and spleen tissue from scrapie-infected sheep had been inadvertently

The case of company Z

Whilst the Inquiry revealed some of the secret workings of government,
pharmaceutical companies have been protected by confidentiality clauses
in the 1968 Medicines Act. The Inquiry was warned not to mention their
names—instead the word "redacted" appears in the transcripts.

The Inquiry heard how investigations found there were 111 medicines
administered by injection using the most risky by-products—brain and lymph.
Most were made from imported material, but a range of homeopathic medicines
and surgical sutures were not. The sutures used for sewing up tissues after
operations were manufactured by the main British supplier referred to as "Z".
They were made from cleaned cow intestines that the company processed at the
rate of 2,500 a day. Against the advice of their own guidelines, officials
renewed the licence on condition the company used intestines from clean beef
cattle 18 months to two years old.

A minority recommended the use of intestines from BSE-free countries. The Inquiry
was shown minutes where officials pointed out that “the agreement with the Company
is ‘confidential' so that there will be no direct comparisons” between the
conditions they had set and the recent ban on offals, including intestines,
for human consumption. Four years later, government officials announced that
a study had detected BSE infectivity at the end of the small intestine from
calves as young as six months old.

By July 1992 the BSE Inquiry was told all vaccines available in Britain fully complied
with the guidelines and did not use British cattle by-products. By the end of the same
year 40,000 cattle had shown symptoms of BSE. The number incubating BSE was much larger.
But what of the stocks of vaccines? According to the Daily Telegraph, the BSE Inquiry
has failed to establish what happened to them and “pharmaceutical companies have so far
declined to volunteer the information”. One Inquiry spokesperson said, “It is possible
that we will never know whether all these vaccines were destroyed or whether they were
used.” All the Labour Health Minister, Tessa Jowell would say is they were
“not disposed of or discontinued”. ...end


Ray Bradley

Private BSE Consultant

Veterinary Laboratories Agency, United Kingdom

There have been two reported incidents of iatrogenic disease in animals,
both involving scrapie. One was in Great Britain (Gordon, Brownlee and
Wilson, 1939, Gordon 1946, 1959) the other in Italy (Capucchio et al, 1998,
Agrimi et al, 1999). Both resulted from infection being
introduced into vaccines, louping ill vaccine in Great Britain, Mycoplasma
agalactiae vaccine in Italy. Each of these vaccines was prepared from
tissues that included sheep brain. In both episodes it seems most likely
that natural scrapie infection was present unknowingly in some brains used
for the purpose. Once prepared and having passed all the conventional
vaccine tests large numbers of sheep in Great Britain, and goats and some
sheep in Italy were inoculated. After the necessary incubation period large
numbers (> 1,000 in each case) of inoculated animals came down with scrapie.
In the meantime some inoculated clinically healthy goats and sheep may have
entered food and feed chains or have been used for other purposes. In the
British outbreak there appears to have been no consequence for humans who
may have consumed infected sheep. It is too early to say what may be the
consequences in Italy but measures have been taken to reduce any risk there
may have been. .........end

Louping-ill vaccine documents from November 23rd, 1946 FULL TEXT


516 No 47. Vol. 58

November 23rd, 1946



The annual Congress, 1946, was held at the Royal Veterinary College,
Royal College Street, London, N.W.I. from September 22nd to September

Opening Meeting

[skip to scrapie vaccine issue...tss]

Papers Presented to Congress


although 176 products do _not_ conform to the CSM/VPC

8. The Secretary of State has a number of licences. We understand that
the inactivated polio vaccine is no longer being used. There is a stock
of smallpox vaccine. We have not been able to determine the source
material. (Made in sheep very unlikely to contain bovine ingredients).

Draft cover letter to product licence holders
(considered by Human and Vet Medicines including deer)

2.3.Iatrogenic exposure

Iatrogenic exposure of scrapie has probably occurred twice. The first report determined that

the vehicle was a louping ill vaccine prepared from sheep tissues and this infected a large

number of sheep sheep (Gordon, 1946, Greig, 1950). The second was more recent and in this

case a vaccine against Mycoplasma agalactiae prepared from sheep tissues was incriminated

(Agrimi et al 1999, Capucchio, 1998) but not all outbreaks could be linked to the use of the

vaccine. In this episode goats were predominantly affected10.

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.

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.


Mr Cunningham CMP3 From: D O Hagger MBI
Dr Salisbury MED/IMCD3
Mr Burton PD/STB/PG1B B/17/2 Date: 15.02.1989
Mr Dudley PD/AD4


1. The purpose of this minute is to alert you to recent developments on
BSE as they affect medicines and to invite representatives to a meeting
in Market Towers on 22 February 1989.

2. The report of the Working Party on Bovine Spongiform
Encephalopathy (BSE) was submitted by the CMO to the Secretary of State
for Health and Minister for Agriculturer on 9 February.

3. The summary at the end of the report records, inter alia: 'we have
drawn the attention of the Licensing Authority to the potential of
transfer of BSE agent in human and veterinary medicinal products. In
paragraph 7 of his submission (Annex A), the CMO notes:

"I am also putting work urgently in hand to satisfy myself that
everything possible has been done to ensure .... that transfer of the
BSE agent in human and veterinary medicinal products does not occur."

4. The Veterinary products Committee meets on 16 February and The
committee on Safety of Medicines on 23 February when each will be
considering a draft of some joint guidelines for manufacturers of
medicinal products which use bovine material as an ingredient or an
intermediate in the manufacturing process (Annex B).....

6. Although a wide range of medicines may be implicated - and the
present proposal is to write to companies for more information - an
"instant" telephone survey of manufacturer of vaccines used for children
has already been undertaken in response to a request from Dr Harris. The
results are in Dr Adams' minute of 14 February (Annex C) - the proviso
in his second paragraph, last sentence should be noted.



MF580439/1 0584

1. I attach a list of questions on BSE and medicines compiled with the
aim of providing question and answer briefing to DH and MAFF Ministers
upon publication of the Southwood Report. I have suggested names of
those who may be able to provide answers.

All recipients are invited to consider which if any important areas have
been missed. Also attached is copy QA briefing being proposed by MAFF. I
understand MAFF have produced General QA briefing on the reports as a


MF580439/1 0585 Question

1. Which medicines are affected? (person to provide reply) Dr. Jefferys

2. Are the risks greater with some medicines than others? Dr. Jefferys

3. Why are medicines affected? Dr. Jefferys

4. Are some affected products available over the counter from pharmacies or shops? Dr. Purves

5. Are only UK products at risk? Dr. Jefferys

6. Are existing stocks safe? Dr. Jefferys

7. Are pre 1980 stocks available? Mr. Burton

8. Are these alternatives to the use of bovine material? Dr. Purves

9. Why can't we throw away suspect stock and import or manufacture safe medicines? Dr. Jefferys

10. Which patients are at risk? Dr. Jefferys

11. Are some patients particularly vulnerable? Dr Jefferys

12. What risks exist to those who have already used these medicines? Dr. Jefferys

13. HOW might patients be affected? Dr. Jefferys

14. Can BSE be transmitted to patients by medicines? Dr. Jefferys

15. How long will it be before risks are quantified? Dr. Jefferys

100 89/02.17/10.2 MF580439/1 0586

16. What research is going on to find out if medicines can transmit this disease and if any
patients have been affected? Dr Jefferys

17. Could recent cases of Creuuzfeld Jacob Disease have been caused by transmission of BSE through medicines? Dr. Jefferys

18. What action is the Licensing Authority taking to ensure proper scrutinising of source materials and manufacturing processes? Dr. Jefferys/Dr. Purves

19. Are the guidelines practical? Dr. Jefferys/Dr. Purves

20. Will the guidelines remove the risk? Dr. Jefferys

21. How will the guidelines be enforced? Dr. Jefferys/Dr. Purves

22. How soon will they come into force? Dr. Jefferys

23. Will the guidelines be published? Mr. Hagger

24. What is being done to reassure patients, parents etc? Mr. Hagger/Dr. Salisbury

25. What advice is being given to doctors, pharmacists etc? Mr. Hagger

26. What advice is the Government giving about its vaccination programme? Dr. Salisbury

27. Is the vaccination programme put at risk because of BSE? Dr. Salisbury


Q. Will government act on this?

A. Yes - thymus is not used in preparation of baby foods but it is
contacting all manufacturers to seek their urgent views on use of
kidneys and liver from ruminants. Will consider any necessary measures
in the light of their response.


Q. Can medicines spread BSE to other cattle/animals?

A. The report describes any risks as remote.

Q. How can risks be avoided?

A. In liaison with the DOH the Veterinary Products Committee is
examining guidelines for the veterinary pharmaceutical industry
which will be issued shortly.

Q. What will Guidelines say?

A. In essence they call for non-bovine sources to be used if possible,
including synthetic material of biotechnological origin. Where this is
not possible the industry should look for sources which are free of BSE
and which are collected in a manner which avoids risk of contamination
by the BSE agent.

89/02.17/10.4 MF580439/1 0588

A. Bovine source material is used in [garbled, cannot read...TSS] and some other medicines.

Q. How many medicines are involved?

A. Computer records show that about 300 of the 3,050 veterinary
medicines licensed in the U.K. are manufactured directly from bovine
source material. However, other medicines may be produced from
bovine sources and a letter is going to all license holders so that a
comprehensive list can be drawn up.

89/06.19/8.1 BSE3/1 0191 Hr J Maslin (MAFF) Ref: Maslin3g

From: Dr H Pickles Med SEB/B Date: 3 July 1989


I was interested to see the list of by-products sent to the HSE. Those
of particular concern included:

* small intestines: sutures (I thought the source was ovine but you are
checking this)

* spinal cord: pharmaceuticals

* thymus: pharmaceuticals

Are you able to give me more information on which UK manufacturers use
these materials? Our proposed ban on bovine offal for human consumption
would not affect these uses, I assume.

Id No. 1934/RD/1 89/08.10/6.1 117A

HELD ON 21 AUGUST 1989 AT 2;15 IN ROOM 720
Miss M Duncan (Chairman)
Mr W Burton
Dr E Hoxey
Mrs J Dhell
Ms K Turner
Dr S Whittle
Mr N Weatherhead
5. The MCA had sent 2700 questionnaires out, 1,124 had made valid
returns; of these 122 use animal material of some kind and there are 582
products involved.
6. The MCA/BSE working group will meet on 6th September. Their
aim is to review responses from professional officers in MCA who have
suggested seven categories of importance (with 1 being the most
important} for medical products:

ID 2267/NRE/1 89/08.21/10.1

1. Products with Bovine brain/lymph tissue administered by injection.

2. Products with bovine tissue other than brain/lymph administered by

3. Tissue implants/open wound dressing/surgical materials/dental and
ophthlamic products with bovine ingredients.

4. Products with bovine ingredients administered topically.

5. Products with bovine ingredients administered orally.

6. Products with other animal/fish/insect/bird ingredients administered
by injection/topically/oral routes.

7. Products with ingredients derived from animal material by chemical
processing (eg stearic acid, gelatine, lanolin ext.

The BSE working group will decide which of these are important, and
should be examined more closely, and which categories can be eliminated.

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.

9. Re-editing of the Paper on "Incubation of Scrapie-like Agents"

It was suggested that the document could be sent out to companies with
the non-standard sterilization Document. The document could have severe
implications on the companies whose products have a high risk factor as
decided by the MCA working group....

11. The Need for a list of High Priority Implantables The commitee decided that no list is
necessary as all implantables, including ones from a human source are of high priority. Concern was
shown over Killingbeck who use human material but had not yet responded.
The company will be chased for a response. Concern was shown over the fact that there may be other scrapie-like
organisms in other animals and further enquiries should be made.

2334q/RD/4 89/08.21/10.7


Glutaraldehyde, formaldehyde, and ethylene oxide are used in the
sterilization of these devices.

However, glutaraldehyde 4,10,12,19 formaldehyde 5,10,11,13,19 and
ethylene oxide 19,23 are all reported to be ineffective methods for
sterilization of material infected with the agents of CJD or scrapie.

Previous advice and research using the agents of CJD and scrapie, has
concentrated on the decontamination of equipment; protection of health
care workers from contaminated human material; human growth hormone; and
dura mater. The methods developed may not be directly applicable or
transferable to material of bovine origin for use in human implantation.

2334q/RD/7 89/08.21/10.10 BSE11/2 020 SC1337

Richmood House 79 Whitehall, London SW1A 2NS
Telephone 01-210-3000
From the Chief Medical Officer
Sir Donald Acheson KBE DM DSc FRCP FFCM FFOM

Mr K C Meldrum
Chief Veterinary Officer
Ministry of Agriculture, Fisheries and Food
Government Buildings
Hook Rise South

3 January 1990

Dear Mr. Meldrum,


You will recall that we have previously discussed the potential risks of
BSE occurring in other Countries as a result of the continuing export
from the UK of meat and bone that may be contaminated by scrapie or
possibly BSE.

I remain concerned that we are not being consistent in our attempts to
contain the risks of BSE. Having banned the feeding of meat and bone
meal to ruminants in 1988, we should take steps to prevent these UK
products being fed to ruminants in other countries. This could be
achieved either through a ban on the export of meat and bone meal, or at
least by the proper labelling of these products to make it absolutely
clear they should not be fed to ruminants. Unless some such action is
taken the difficult problems we have faced with BSE may well occur in
other countries who import UK meat and bone meal. Surely it is short
sighted for us to risk being seen in future as having been responsible
for the introduction of BSE to the food chain in other countries.

I would be very interested to hear how you feel this gap in the present
prcautionary measures to eliminate BSE should be closed. We should be
aiming at the global elimination of this new bovine disease. The export
of our meat and bone meal is a continuing risk to other countries.

Sincerely Donald Acheson

Did the US import fetal calf serum and vaccines from BSE-affected countries?

3002.10.0040: FETAL BOVINE SERUM (FBS)
U.S. Imports for Consumption: December 1998 and 1998 Year-to-Date
(Customs Value, in Thousands of Dollars)
(Units of Quantity: Kilograms)

<--- Dec 1998 ---> <--- 1998 YTD --->
Country Quantity Value Quantity Value
WORLD TOTAL . . . . . . . 2,727 233 131,486 8,502
Australia . . . . . . . . --- --- 19,637 2,623
Austria . . . . . . . . . --- --- 2,400 191
Belgium . . . . . . . . . --- --- 17 32
Canada . . . . . . . . . 900 110 30,983 3,220
Costa Rica . . . . . . . 500 20 4,677 169
Federal Rep. of Germany --- --- 105 21
Finland . . . . . . . . . 1 8 9 83
France . . . . . . . . . --- --- 73 7
Guatemala . . . . . . . . --- --- 719 42
Honduras . . . . . . . . --- --- 1,108 88
Israel . . . . . . . . . --- --- 24 165
Netherlands . . . . . . . --- --- 1 5
New Zealand . . . . . . . 26 5 65,953 913
Panama . . . . . . . . . --- --- 1,195 64
Switzerland . . . . . . . 971 8 1,078 23
United Kingdom . . . . . 329 82 743 756
Uruguay . . . . . . . . . --- --- 2,764 98
U.S. Imports for Consumption: December 1998 and 1998 Year-to-Date
(Customs Value, in Thousands of Dollars)
(Units of Quantity: Kilograms)

<--- Dec 1998 ---> <--- 1998 YTD --->
Country Quantity Value Quantity Value
WORLD TOTAL . . . . . . . 25,702 26,150 550,258 378,735
Austria . . . . . . . . . --- --- 45 225
Belgium . . . . . . . . . 14,311 12,029 248,041 199,036
Canada . . . . . . . . . 1,109 1,527 15,798 16,305
Denmark . . . . . . . . . 80 234 246 682
Federal Rep. of Germany 1,064 4,073 12,001 6,329
France . . . . . . . . . 3,902 4,859 87,879 92,845
Ireland . . . . . . . . . --- --- 120 478
Italy . . . . . . . . . . --- --- 2,359 81
Japan . . . . . . . . . . 445 1,903 11,350 11,298
Netherlands . . . . . . . --- --- 94 6
Republic Of South Africa --- --- 2 1
Spain . . . . . . . . . . --- --- 60 30
Switzerland . . . . . . . 716 353 9,303 4,271
United Kingdom . . . . . 4,075 1,172 162,960 47,148
U.S. Imports for Consumption: December 1998 and 1998 Year-to-Date
(Customs Value, in Thousands of Dollars)
(Units of Quantity: Kilograms)

<--- Dec 1998 ---> <--- 1998 YTD --->
Country Quantity Value Quantity Value
WORLD TOTAL . . . . . . . 6,528 237 87,149 2,715
Canada . . . . . . . . . --- --- 2,637 305
Federal Rep. of Germany --- --- 104 5
Netherlands . . . . . . . 138 64 472 192
New Zealand . . . . . . . 6,390 173 83,882 1,895
United Kingdom . . . . . --- --- 54 318


My submission to FDA about this ;


File Format: PDF/Adobe Acrobat -

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

Sr. [] Monday, January 08,200l 3:03 PM freas ...

Asante/Collinge et al, that BSE transmission to the 129-methionine

genotype can lead to an alternate phenotype that is indistinguishable

from type 2 PrPSc, the commonest _sporadic_ CJD;

Date: Sun, 7 Jan 2001 09:45:19 -0800
Reply-To: Sustainable Agriculture Network Discussion Group
<[log in to unmask]>
Sender: Sustainable Agriculture Network Discussion Group
<[log in to unmask]>
From: Beth von Gunten <[log in to unmask]>
Content-Type: text/plain; charset="us-ascii" ; format="flowed"


1:00-2:00 PM EST CALL: 1-888-273-9887

A special "50 STATE CONFERENCE CALL" to discuss BSE (Bovine
Spongiform Encephalopathy) issues for Food and Drug Administration
(FDA) regulated animal feed products in the United States and
imported animal feeds. The conference call will
discuss the FDA proposed response to the current BSE issue and the
assistance needed from state feed and agriculture programs. THIS

The 50 State call is scheduled for Tuesday, January 9, 2001 from
1:00-2:00 pm EST. Any state agency responsible for animal feed issues
wishing to participate should call 1-888-273-9887 and ask to be
connected to the "50 State BSE Call". The conference host operator
will explain how to participate, including asking questions during
the call. If possible, please coordinate within your state to utilize
only one phone line per state agency.

We request that you forward this message to your agency management
and feed coordinators or other agencies or departments who may be
responsible for any animal feed issues related to FDA regulated

The agenda will be as follows:

1. Center For Veterinary Medicine (FDA) - Discussion of the problem
related to BSE events in Europe and the impact on US feed ingredients
for animals and feed operations. Discussion of the proposed
actions/inspections/compliance of licensed and unlicensed feed mills,
commercial feed manufacturers, animal feed imports, renderer's,
protein blenders, on-farm mixers, and ruminant feeders.

2. Office of Regional Operations (FDA) - Discussion of
contracting/working with states to inspect the universe of feed
mills/industry for "Animal Proteins Prohibited from Use in Animal
Feed". Discussion of working with FDA field offices.

3. Questions and answers.

Richard H. Barnes, Director
Division of Federal-State Relations (HFC-150)
5600 Fishers Lane Room 1207
Rockville, Md. 20857
ph: (301) 827-6906 FAX: (301) 443-2143
Email: [log in to unmask]

Subject: U.S.A. - 50 STATE BSE CONFERENCE CALL JAN. 9, 2001 (my notes)
Date: January 10, 2001 at 1:36 pm PST

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

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

Greetings List Members,

I was lucky enough to sit in on this BSE conference
call today and even managed to ask a question.
that is when the trouble started.

I submitted a version of my notes to
Sandra Blakeslee of the New York Times,
whom seemed very upset, and rightly

"They tell me it is a closed meeting and
they will release whatever information
they deem fit. Rather infuriating."

and i would have been doing just fine,
until i asked my question. i was surprised
my time to ask a question so quick.

(understand, these are taken from my notes for now.
the spelling of names and such could be off.)

[host Richard Barns]

and now a question from Terry S. Singeltary of
CJD Watch.


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

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

[host Richard]

could you repeat the question?


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

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

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

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

you are not going to answer my question?

[not sure whom speaking]


from this point, i was still connected, got to listen
and tape the whole conference. at one point someone
came on, a woman, and ask again;

[unknown woman]

what group are you with?


CJD Watch and my Mom died from hvCJD
we are trying to tract down CJD and other
human TSE's world wide. i was invited to
sit in on this from someone inside the USDA/APHIS
and that is why i am here. do you intend on banning
me from this conference now?

at this point the conference was turned back up,
and i got to finish listening. They never answered
or even addressed my one question, or even addressed
the issue. BUT, i will try and give you a run-down
for now, of the conference.

IF i were another Country, I would take heed to my
notes, BUT PLEASE do not depend on them. ask for
transcript from;


he would be glad to give you one ;-)

Rockville Maryland,
Richard Barns Host

BSE issues in the U.S.,

How they were labelling ruminant feed?

Revising issues.

The conference opened up with the explaining of
the U.K. BSE epidemic winding down with about 30
cases a week.

although new cases in other countries were now

Look at Germany whom said NO BSE and now have BSE.

BSE increasing across Europe.

Because of Temporary Ban on certain rendered product,
heightened interest in U.S.

A recent statement in Washington Post, said the
New Administration (old GW) has a list of issues.
BSE is one of the issues.

BSE Risk is still low, minimal in U.S. with a greater
interest in MBM not to enter U.S.

HOWEVER, if BSE were to enter the U.S.
it would be economically disastrous
to the render, feed, cattle, industries,
and for human health.

(human health-they just threw that in cause i was listening.
I will now jot down some figures in
which they told you, 'no need to write them down'.
just hope i have them correct. hmmm, maybe i hope
i don't ???)

80% inspection of rendering

*Problem-Complete coverage of rendering HAS NOT

sizeable number of 1st time FAILED INITIAL INSPECTION,
have not been reinspected (70% to 80%).

Compliance critical, Compliance poor in U.K.
and other European Firms.

Gloria Dunason
Major Assignment 1998 goal TOTAL compliance.
This _did not_ occur. Mixed level of compliance,
depending on firm.

Rendering FDA license and NON FDA license

system in place for home rendering & feed
76% in compliance
79% cross contamination
21% DID NOT have system
92% record keeping
less than 60% total compliance

279 inspectors
185 handling prohibited materials

Renderer at top of pyramid, significant
part of compliance.
84% compliance

failed to have caution statement render
72% compliance & cross contamination
caution statement on feed, 'DO NOT FEED TO CATTLE'


1240 FDA license feed mills
846 inspected

"close to 400 feed mills have not been inspected"

80% compliance for feed.

10% don't have system.

NON-FDA licensed mills
There is NO inventory on non licensed mills.
approximately 6000 to 8000 Firms ???
4,344 ever inspected.
"FDA does not have a lot of experience with"

40% do NOT have caution statement 'DO NOT FEED'.

74% Commingling compliance

"This industry needs a lot of work and only half
gotten to"

"700 Firms that were falitive, and need to be
re-inspected, in addition to the 8,000 Firms."

Quote to do BSE inspection in 19 states by end
of January or 30 days, and other states 60 days.
to change feed status??? Contract check and ask
questions and pass info.

At this time, we will take questions.

[I was about the third or fourth to ask question.
then all B.S.eee broke loose, and i lost my train
of thought for a few minutes. picked back up here]

someone asking about nutritional supplements and
sourcing, did not get name. something about inspectors
not knowing of BSE risk??? the conference person assuring that Steve
Follum? and the TSE advisory Committee were
handling that.

Some other Dr. Vet, whom were asking questions
that did not know what to do???

[Dennis Wilson]
California Food Agr.
Imports, are they looking at imports?

[Conference person]
they are looking at imports,
FDA issued imports Bulletin.

[Linda Singeltary ??? this was a another phone in
question, not related i don't think]
Why do we have non-licensed facilities?

(conference person)
other feed mills do not handle as potent drugs???

Dennis Blank, Ken Jackson
licensed 400
non FDA 4400 inspected of a total of 6000 to 8000,

(they really don't know how many non licensed Firms
in U.S. they guess 6000 to 8000??? TSS)

Linda Detwiler
asking everyone (me) not to use emergency BSE number,
unless last resort.
(i thought of calling them today, and reporting the
whole damn U.S. cattle herd ;-) 'not'

Warren-Maryland Dept. Agr.
Prudent to re-inspect after 3 years.
concerned of Firms that have changed



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


ALL the warnings have been there, most just chose to ignore them, now only time will tell who has to pay the final price.
sadly, some like Lester Crawford reaped the rewards of ignoring these risk factors $$$ you cannot put the wolf in guard
of the hen house, and the fda, usda, aphis, fsis, et al are full of these wolves guarding the hen houses ;

Sentencing Is Delayed in Case Of Former FDA Commissioner

Former FDA Commissioner Lester Crawford's sentencing on charges he lied about his stock holdings was delayed Tuesday over
questions about sentencing guidelines. Under a deal worked out between his attorney and federal prosecutors, Mr. Crawford had
agreed earlier to a $50,000 fine and probation. Magistrate Judge Deborah A. Robinson asked the attorneys to explain why they didn't
use certain federal sentencing guidelines in ... snip...end

no conflict of interest there right ???

WHAT else did old lester crawford lie about, and whom reaped what from that $$$

Press Release
Monday, Jan. 26, 2004
FDA Press Office

Expanded "Mad Cow" Safeguards Announced to Strengthen Existing Firewalls Against BSE Transmission

HHS Secretary Tommy G. Thompson today announced several new public health measures, to be implemented by the Food and
Drug Administration (FDA), to strengthen significantly the multiple existing firewalls that protect Americans from exposure to the agent
thought to cause bovine spongiform encephalopathy (BSE, also known as mad cow disease) and that help prevent the spread of BSE in U.S. cattle.

The existing multiple firewalls, developed by both the U.S. Department of Agriculture (USDA) and HHS, have been extremely effective in protecting
the American consumer from exposure to BSE. The first firewall is based on import controls started in 1989. A second firewall is surveillance of the
U.S. cattle population for the presence of BSE, a USDA firewall that led to the finding of the BSE cow in December. The third firewall is FDA's 1997
animal feed ban, which is the critical safeguard to help prevent the spread of BSE through cattle herds by prohibiting the feeding of most mammalian
protein to ruminant animals, including cattle. The fourth firewall, recently announced by USDA, makes sure that no bovine tissues known to be at high
risk for carrying the agent of BSE enter the human food supply regulated by USDA. The fifth firewall is effective response planning to contain the
potential for any damage from a BSE positive animal, if one is discovered. This contingency response plan, which had been developed over the past
several years, was initiated immediately upon the discovery of a BSE positive cow in Washington State December 23.

The new safeguards being announced today are science-based and further bolster these already effective safeguards.

Specifically, HHS intends to ban from human food (including dietary supplements), and cosmetics a wide range of bovine-derived material so that the
same safeguards that protect Americans from exposure to the agent of BSE through meat products regulated by USDA also apply to food products that
FDA regulates.

FDA will also prohibit certain currently allowed feeding and manufacturing practices involving feed for cattle and other ruminant animals. These additional
measures will further strengthen FDA's 1997 "animal feed" rule.

"Today's actions will make strong public health protections against BSE even stronger," Secretary Thompson said. "Although the current animal feed
rule provides a strong barrier against the further spread of BSE, we must never be satisfied with the status quo where the health and safety of our
animals and our population is at stake. The science and our own experience and knowledge in this area are constantly evolving. Small as the risk
may already be, this is the time to make sure the public is protected to the greatest extent possible."

"Today we are bolstering our BSE firewalls to protect the public," said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "We are further strengthening
our animal feed rule, and we are taking additional steps to further protect the public from being exposed to any potentially risky materials from cattle.
FDA's vigorous inspection and enforcement program has helped us achieve a compliance rate of more than 99 percent with the feed ban rule, and we
intend to increase our enforcement efforts to assure compliance with our enhanced regulations. Finally, we are continuing to assist in the development
of new technologies that will help us in the future improve even further these BSE protections. With today's actions, FDA will be doing more than ever
before to protect the public against BSE by eliminating additional potential sources of BSE exposure."

To implement these new protections, FDA will publish two interim final rules that will take effect immediately upon publication, although there will be an
opportunity for public comment after publication.

The first interim final rule will ban the following materials from FDA-regulated human food, (including dietary supplements) and cosmetics:

Any material from "downer" cattle. ("Downer" cattle are animals that cannot walk.)

Any material from "dead" cattle. ("Dead" cattle are cattle that die on the farm (i.e. before reaching the slaughter plant);

Specified Risk Materials (SRMs) that are known to harbor the highest concentrations of the infectious agent for BSE, such as the brain,
skull, eyes, and spinal cord of cattle 30 months or older, and a portion of the small intestine and tonsils from all cattle, regardless of their age or health;


The product known as mechanically separated beef, a product which may contain SRMs. Meat obtained by Advanced Meat Recovery (an
automated system for cutting meat from bones), may be used since USDA regulations do not allow the presence of SRMs in this product.

The second interim final rule is designed to lower even further the risk that cattle will be purposefully or inadvertently fed prohibited protein. It was the
feeding of such protein to cattle that was the route of disease transmission that led to the BSE epidemic in United Kingdom cattle in the 1980's and 1990's.
This interim final rule will implement four specific changes in FDA's present animal feed rule. First, the rule will eliminate the present exemption in the feed
rule that allows mammalian blood and blood products to be fed to other ruminants as a protein source. Recent scientific evidence suggests that blood can
carry some infectivity for BSE.

Second, the rule will also ban the use of "poultry litter" as a feed ingredient for ruminant animals. Poultry litter consists of bedding, spilled feed, feathers,
and fecal matter that are collected from living quarters where poultry is raised. This material is then used in cattle feed in some areas of the country where
cattle and large poultry raising operations are located near each other. Poultry feed may legally contain protein that is prohibited in ruminant feed, such as
bovine meat and bone meal. The concern is that spillage of poultry feed in the chicken house occurs and that poultry feed (which may contain protein
prohibited in ruminant feed) is then collected as part of the "poultry litter" and added to ruminant feed.

Third, the rule will ban the use of "plate waste" as a feed ingredient for ruminants. Plate waste consists of uneaten meat and other meat scraps that are
currently collected from some large restaurant operations and rendered into meat and bone meal for animal feed. The use of "plate waste" confounds
FDA's ability to analyze ruminant feeds for the presence of prohibited proteins, compromising the Agency's ability to fully enforce the animal feed rule.

Fourth, the rule will further minimize the possibility of cross-contamination of ruminant and non-ruminant animal feed by requiring equipment, facilities or
production lines to be dedicated to non-ruminant animal feeds if they use protein that is prohibited in ruminant feed. Currently, some equipment, facilities
and production lines process or handle prohibited and non-prohibited materials and make both ruminant and non-ruminant feed -- a practice which could
lead to cross-contamination.

To accompany these new measures designed to provide a further layer of protection against BSE, FDA will in 2004 step up its inspections of feed mills
and renderers. FDA will itself conduct 2,800 inspections and will make its resources go even further by continuing to work with state agencies to fund 3,100
contract inspections of feed mill and renderers and other firms that handle animal feed and feed ingredients. Through partnerships with states, FDA will also
receive data on 700 additional inspections, for a total of 3,800 state contract and partnership inspections in 2004 alone, including annual inspections of 100
percent of all known renderers and feed mills that process products containing materials prohibited in ruminant feed.

"We have worked hard with the rendering and animal feed production industries to try and achieve full compliance with the animal feed rule," said Dr. McClellan,
"and through strong education and a vigorous enforcement campaign, backed by additional inspections and resources, we intend to maintain a high level of compliance."
Dr. McClellan also noted that, in response to finding a BSE positive cow in Washington state December 23, FDA inspected and traced products at 22 facilities related
to that positive cow or products from the cow, including feed mills, farms, dairy farms, calf feeder lots, slaughter houses, meat processors, transfer stations, and
shipping terminals. Moreover, FDA has conducted inspections at the rendering facilities that handled materials from the positive cow, and they were found to be
fully in compliance with FDA's feed rule.

To further strengthen protections for Americans, FDA/HHS intends to work with Congress to consider proposals to assure that these important protective measures
will be implemented as effectively as possible.

FDA is also continuing its efforts to assist in the development of better BSE science, to achieve the same or greater confidence in BSE protection at a lower cost.
For example, to enhance the ability of our public health system to detect prohibited materials in animal feed, FDA will continue to support the development and
evaluation of diagnostic tests to identify prohibited materials. These tests would offer a quick and reliable method of testing animal feeds for prohibited materials
and for testing other products for contamination with the agent thought to cause BSE.

FDA has publicly discussed many of the measures being announced today with stakeholders in workshops, videoconferences, and public meetings. In addition,
FDA published an Advance Notice of Proposed Rulemaking in November 2002 (available online at
concerning possible changes to the animal feed rule.

Comprehensive information about FDA's work on BSE and links to other related websites are available at



JANUARY 27, 2004


Mr. Chairman, Members of the Committee, thank you for the opportunity to participate in today’s hearing on measures taken by the Federal government to
safeguard human and animal health in the United States from Bovine Spongiform Encephalopathy (BSE) and the response to the finding of a BSE-positive
cow in the State of Washington. I am Dr. Lester M. Crawford, Deputy Commissioner, Food and Drug Administration (FDA or the Agency).

The mission of FDA is to protect the public health by assuring the safety and efficacy of our nation’s human and veterinary drugs, human biological products,
medical devices, human and animal food supply, cosmetics, and radiation emitting products. In fulfilling this mission, FDA is the Agency responsible for
assuring that all FDA-regulated products remain safe and uncompromised from BSE and related diseases. Many FDA-regulated products contain bovine
ingredients, for example, heart valves, ophthalmic devices, dental products, wound dressings, injectable drugs, vaccines, soups, gravies, sausage casings,
and animal feeds.

FDA has long been actively involved nationally and internationally in efforts to understand and prevent the spread of BSE. FDA collaborates extensively with
the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the Animal and Plant Health Inspection Service (APHIS) and
the Food Safety and Inspection Service (FSIS) within the U.S. Department of Agriculture (USDA), Customs and Border Protection (CBP), the Environmental
Protection Agency (EPA), other Federal agencies, state and local jurisdictions, and with affected industries and consumer groups. Many of these activities
fit within the framework of the Department of Health and Human Service’s (HHS or the Department) Bovine Spongiform Encephalopathy/Transmissible
Spongiform Encephalopathy (BSE/TSE) Action Plan, which was released in August 2001. This collaboration over many years has enabled FDA to strengthen
safeguards for FDA-regulated products and to respond quickly and effectively to the first case of BSE within the U.S.

Executive Summary

The mission of the Agency is to protect the public health by assuring the safety and efficacy of our nation’s human and veterinary drugs, human biological
products, medical devices, human and animal food supply, cosmetics, and radiation emitting products. In fulfilling this mission, FDA is the Agency
responsible for assuring that all FDA-regulated products remain safe and uncompromised from BSE and related diseases.

BSE is a progressive neurological disorder of cattle that results from infection by an unconventional transmissible agent, and was first diagnosed in the
United Kingdom (U.K.) in 1986. Many FDA-regulated products contain bovine ingredients, for example, heart valves, ophthalmic devices, dental products,
wound dressings, injectable drugs, vaccines, soups, gravies, sausage casings, and animal feeds and thus must be taken into consideration as part the
effort to prevent infectivity by BSE.

FDA has a longstanding commitment to protecting consumers from BSE by following multiple measures designed to safeguard FDA-regulated products
from possible contamination by the BSE agent. Under the Federal Food, Drug, and Cosmetic (FD&C) Act, FDA has the authority to prevent the adulteration
and misbranding of FDA-regulated products. Further, for medical products that require pre-market approval (e.g., drugs under Section 505 and medical
devices under Section 513 of the FD&C Act), FDA has addressed safety concerns related to BSE through requirements of the application and approval

The U.S. employs a robust multi-layered approach to preventing the introduction and amplification of BSE. While the goal of this approach is to achieve
an extremely high level of compliance with each preventative measure, this multi-layered approach is designed to protect the U.S. consumer from exposure
to the BSE infective material, and to date this approach has been working. Since 1989, USDA has prohibited the importation of live animals and animal
products from BSE-positive countries. Since 1997, FDA has prohibited the use of certain mammalian proteins in the manufacture of ruminant feed. FDA
continues to implement policies to keep safe all FDA-regulated products, including food, food ingredients, dietary supplements, drugs, vaccines, and
cosmetics from risk of any BSE-contaminated bovine material. As a result of these multiple regulatory safeguards, the risk of exposure to BSE through
products, FDA regulates remains extremely low in the U.S.

FDA’s 1997 animal feed regulation forms the basis of the Agency’s efforts to prevent the spread of BSE through animal feed. This rule prohibits the use
of most mammalian protein in the manufacture of animal feeds for ruminants. FDA implemented this rule to establish in our country feeding practices
consistent with the best science and epidemiological knowledge known at the time to prevent the spread of BSE throughout herds of U.S. cattle. A risk
assessment sponsored by USDA and conducted by the Harvard Center for Risk Analysis, released in November 2001, identified FDA’s feed ban as one
of the primary safeguards against the spread of BSE in U.S. cattle.

To maximize protection afforded by the feed regulation, FDA has developed and implemented a BSE/Ruminant Feed Ban Inspection compliance program
and established the goal of 100 percent compliance. FDA’s strategy for achieving uniform compliance with the feed rule focuses on three areas: education,
inspection, and enforcement. FDA and its state counterparts conduct, at least annually, targeted BSE inspections of 100 percent of known renderers,
protein blenders, and feed mills processing products containing material prohibited from use in ruminant feed. Compliance by these establishments
with FDA’s feed rule is estimated to be at better than 99 percent. As of December 20, 2003, FDA had received over 26,000 inspection reports
(6,404 for Fiscal Year 2003). The majority of these inspections (around 70 percent) were conducted by state officials for FDA, with the remainder conducted
by FDA officials. The total number of inspection reports represents 13,672 firms, 1,949 of which are active and handle materials prohibited from use in
ruminant feed. The 1,949 active firms that handle prohibited material have been inspected by FDA and, as of December 31, 2003, only five were found to
have significant violations, resulting in official action indicated (OAI). FDA is working with these firms to bring them into compliance.

On December 23, 2003, FDA was notified by USDA of a presumptive-positive finding of BSE in a cow in Washington State. FDA immediately initiated its BSE
Emergency Response Plan. As part of the plan, FDA has been coordinately closely with USDA so that we can effectively investigate this BSE case, trace the
various products involved, and take the appropriate steps to protect the public. FDA investigators and inspectors located the high risk material rendered
from the infected cow, and the rendering plants placed a hold on the rendered material, which is being disposed of appropriately. I am happy to report that
all of the establishments inspected by FDA during the course of the investigation were in compliance with the feed ban. In addition, to help address the
concerns of foreign governments and restore confidence in American products, FDA has participated, along with USDA, in numerous meetings and
consultations with foreign governments since USDA surveillance found the BSE-positive cow.

In addition to new policies and regulations, new knowledge and tools gained through applied research can greatly help us to be more effective in our
regulatory mission, such as protecting the country from BSE. Several of FDA’s Centers, as well as many private laboratories, academic institutions, and
other Federal agencies (most notably NIH) are also involved in significant research activities relating to TSEs. Basic areas requiring research include:
increasing our understanding of prions, learning how prions are transmitted within a species and potentially between species, developing diagnostic
tests for humans and animals, developing detection methods for use on regulated products, developing methods to increase or eliminate infectivity,
and designing new treatments. We are optimistic about the promise of new technologies, such as better methods to quickly distinguish the species of
proteins and sensors to detect abnormal prions in food. Development of these technologies can contribute significantly to the effort to prevent the
spread of BSE and must be considered carefully when evaluating potential regulatory changes to address BSE.

At the time that FDA implemented the feed rule in 1997, the Agency also recognized that evolving, complex scientific and public health issues,
particularly regarding BSE required the Agency to continue to assess and scrutinize the rule to ensure its integrity as a firewall against the potential
for spread of BSE. To further explore ways the animal feed regulation could be improved in November 2002, FDA published an advance notice of
proposed rulemaking (ANPR) soliciting information and views from the affected industries and the public on some potential changes to its current
feed regulation, including ways that the animal feed regulation could be strengthened. Although the risk of exposure to BSE in the U.S. remains
extremely low and the measures in place are working, as a result of the recently discovered infected cow in the state of Washington, the Agency
is evaluating the appropriateness of additional science-based measures to further strengthen our current protections.

Yesterday, Department Secretary Tommy Thompson and FDA Commissioner Mark McClellan announced several additional public health
measures to further strengthen the current robust safeguards that help protect Americans from exposure to the agent that causes BSE and
help prevent the spread of BSE in U.S. cattle. These measures relate to both protections for foods intended for human consumption as well
as additional measures to strengthen FDA’s 1997 final rule regulating animal feed. With respect to human foods, FDA announced that it will
extend to FDA-regulated foods, dietary supplements and cosmetics, restrictions on using specified risk materials that would complement the
recent USDA announcements. Concerning animal feed, the Agency announced a series of measures designed to lower even further the risk
that cattle will be purposefully or inadvertently fed “ruminant” proteins, including, eliminating an exemption in the feed rule that allows mammalian
blood and blood products at slaughter to be fed to ruminants as a protein source; banning the use of “poultry litter” as a feed ingredient for cattle
and other ruminants; prohibiting the use of “plate waste” as a feed ingredient for ruminants, including cattle; and taking steps to further minimize
the possibility of cross-contamination of animal feed via equipment, facilities or production lines.

Finally, FDA is increasing its inspections of feed mills and renderers in 2004. Our 2001 base funding for BSE-related activities was $3.8 million.
We shifted resources internally in 2001 and received a substantial increase from Congress in 2002. Our funded level for 2004 is currently approximately
$21.5 million, almost a five-fold increase over the 2001 base. FDA will itself conduct 2,800 inspections and will make its resources go even further by
working with state agencies to fund 3,100 contract inspections of feed mills and renderers and other firms that handle animal feed and feed ingredients.
Through partnerships with states, FDA will also receive data on 700 additional inspections, for a total of 3,800 state contract and partnership inspections
in 2004. These inspections would include 100 percent of all known renderers and feed mills that process products containing prohibited materials.
The Agency looks forward to continuing to assist Congress as it evaluates the risks associated with BSE, identifies opportunities to promote technologies
that will detect and prevent the spread of BSE, and considers science-based approaches to further strengthen regulatory protections and bolster the
resources available to assist Federal, state, local and private efforts to assure that BSE does not present a threat to human or animal health in the U.S.

Background on Bovine Spongiform Encephalopathy (BSE) .................


For Immediate Release
July 9, 2004
FSIS Press Office
APHIS Press Office
FDA Media Relations
(202) 720-9113
(202) 734-7799
(301) 827-6242

USDA and HHS Strengthen Safeguards Against
Bovine Spongiform Encephalopathy

PLEASE NOTE, WERE STILL WAITING for some of these BSE/TSE safeguards $$$

some of those promises above have still yet to be implemented, AND, the USDA/FDA et al are still feeding cows to cows in 2006 ;


Date: September 6, 2006 at 7:58 am PST


a) EVSRC Custom dairy feed, Recall # V-130-6;
b) Performance Chick Starter, Recall # V-131-6;
c) Performance Quail Grower, Recall # V-132-6;
d) Performance Pheasant Finisher, Recall # V-133-6.
Donaldson & Hasenbein/dba J&R Feed Service, Inc., Cullman, AL, by telephone
on June 23, 2006 and by letter dated July 19, 2006. Firm initiated recall is
Dairy and poultry feeds were possibly contaminated with ruminant based
477.72 tons

a) Dairy feed, custom, Recall # V-134-6;
b) Custom Dairy Feed with Monensin, Recall # V-135-6.
None. Bulk product
Recalling Firm: Burkmann Feed, Greeneville, TN, by Telephone beginning on
June 28, 2006.
Manufacturer: H. J. Baker & Bro., Inc., Albertville, AL. Firm initiated
recall is complete.
Possible contamination of dairy feeds with ruminant derived meat and bone
1,484 tons
TN and WV

MS, AL, GA, AND TN 11,000+ TONS
Date: August 16, 2006 at 9:19 am PST
Bulk custom made dairy feed, Recall # V-115-6
Hiseville Feed & Seed Co., Hiseville, KY, by telephone and letter on or
about July 14, 2006. FDA initiated recall is ongoing.
Custom made feeds contain ingredient called Pro-Lak which may contain
ruminant derived meat and bone meal.
Approximately 2,223 tons
Bulk custom made dairy feed, Recall # V-116-6
Rips Farm Center, Tollesboro, KY, by telephone and letter on July 14, 2006.
FDA initiated recall is ongoing.
Custom made feeds contain ingredient called Pro-Lak which may contain
ruminant derived meat and bone meal.
1,220 tons
Bulk custom made dairy feed, Recall # V-117-6
Kentwood Co-op, Kentwood, LA, by telephone on June 27, 2006. FDA initiated
recall is completed.
Possible contamination of animal feed ingredients, including ingredients
that are used in feed for dairy animals, with ruminant derived meat and bone
40 tons
LA and MS
Bulk Dairy Feed, Recall V-118-6
Cal Maine Foods, Inc., Edwards, MS, by telephone on June 26, 2006. FDA
initiated recall is complete.
Possible contamination of animal feed ingredients, including ingredients
that are used in feed for dairy animals, with ruminant derived meat and bone
7,150 tons
Bulk custom dairy pre-mixes, Recall # V-119-6
Walthall County Co-op, Tylertown, MS, by telephone on June 26, 2006. Firm
initiated recall is complete.
Possible contamination of dairy animal feeds with ruminant derived meat and
bone meal.
87 tons
Bulk custom dairy pre-mixes, Recall # V-120-6
Ware Milling Inc., Houston, MS, by telephone on June 23, 2006. Firm
initiated recall is complete.
Possible contamination of dairy animal feeds with ruminant derived meat and
bone meal.
350 tons
AL and MS
a) Tucker Milling, LLC Tm 32% Sinking Fish Grower, #2680-Pellet,
50 lb. bags, Recall # V-121-6;
b) Tucker Milling, LLC #31120, Game Bird Breeder Pellet,
50 lb. bags, Recall # V-122-6;
c) Tucker Milling, LLC #31232 Game Bird Grower,
50 lb. bags, Recall # V-123-6;
d) Tucker Milling, LLC 31227-Crumble, Game Bird Starter, BMD
Medicated, 50 lb bags, Recall # V-124-6;
e) Tucker Milling, LLC #31120, Game Bird Breeder, 50 lb bags,
Recall # V-125-6;
f) Tucker Milling, LLC #30230, 30 % Turkey Starter, 50 lb bags,
Recall # V-126-6;
g) Tucker Milling, LLC #30116, TM Broiler Finisher,
50 lb bags, Recall # V-127-6
All products manufactured from 02/01/2005 until 06/20/2006
Recalling Firm: Tucker Milling LLC, Guntersville, AL, by telephone and visit
on June 20, 2006, and by letter on June 23, 2006.
Manufacturer: H. J. Baker and Brothers Inc., Stamford, CT. Firm initiated
recall is ongoing.
Poultry and fish feeds which were possibly contaminated with ruminant based
protein were not labeled as "Do not feed to ruminants".
7,541-50 lb bags
AL, GA, MS, and TN

COMMERCE 27,694,240 lbs
Date: August 6, 2006 at 6:14 pm PST
Bulk custom dairy feds manufactured from concentrates, Recall # V-113-6
All dairy feeds produced between 2/1/05 and 6/16/06 and containing H. J.
Baker recalled feed products.
Vita Plus Corp., Gagetown, MI, by visit beginning on June 21, 2006. Firm
initiated recall is complete.
The feed was manufactured from materials that may have been contaminated
with mammalian protein.
27,694,240 lbs


TONS Products manufactured from 02/01/2005 until 06/06/2006
Date: August 6, 2006 at 6:16 pm PST
a) CO-OP 32% Sinking Catfish, Recall # V-100-6;
b) Performance Sheep Pell W/Decox/A/N, medicated,
net wt. 50 lbs, Recall # V-101-6;
c) Pro 40% Swine Conc Meal -- 50 lb, Recall # V-102-6;
d) CO-OP 32% Sinking Catfish Food Medicated,
Recall # V-103-6;
e) "Big Jim's" BBB Deer Ration, Big Buck Blend,
Recall # V-104-6;
f) CO-OP 40% Hog Supplement Medicated Pelleted,
Tylosin 100 grams/ton, 50 lb. bag, Recall # V-105-6;
g) Pig Starter Pell II, 18% W/MCDX Medicated 282020,
Carbadox -- 0.0055%, Recall # V-106-6;
Feed for Chickens from Hatch to 20 Weeks, Medicated,
Bacitracin Methylene Disalicylate, 25 and 50 Lbs,
Recall # V-107-6;
i) CO-OP LAYING PELLETS, Complete Feed for Laying
Chickens, Recall # 108-6;
j) CO-OP LAYING CRUMBLES, Recall # V-109-6;
net wt 50 Lbs, Recall # V-110-6;
Recall # V-111-6;
Recall # V-112-6
Product manufactured from 02/01/2005 until 06/06/2006
Alabama Farmers Cooperative, Inc., Decatur, AL, by telephone, fax, email and
visit on June 9, 2006. FDA initiated recall is complete.
Animal and fish feeds which were possibly contaminated with ruminant based
protein not labeled as "Do not feed to ruminants".
125 tons
AL and FL


Date: August 6, 2006 at 6:19 pm PST
Bulk custom made dairy feed, Recall # V-114-6
Burkmann Feeds LLC, Glasgow, KY, by letter on July 14, 2006. Firm initiated
recall is ongoing.
Custom made feeds contain ingredient called Pro-Lak, which may contain
ruminant derived meat and bone meal.

Sun Jul 16, 2006 09:22

a) PRO-LAK, bulk weight, Protein Concentrate for Lactating Dairy Animals,
Recall # V-079-6;
b) ProAmino II, FOR PREFRESH AND LACTATING COWS, net weight 50lb (22.6 kg),
Recall # V-080-6;
FEED, Recall # V-081-6;
d) Feather Meal, Recall # V-082-6
a) Bulk
b) None
c) Bulk
d) Bulk
H. J. Baker & Bro., Inc., Albertville, AL, by telephone on June 15, 2006 and
by press release on June 16, 2006. Firm initiated recall is ongoing.
Possible contamination of animal feeds with ruminent derived meat and bone
10,878.06 tons

Date: June 27, 2006 at 7:42 am PST
Public Health Service
Food and Drug Administration
New Orleans District
297 Plus Park Blvd.
Nashville, TN 37217
Telephone: 615-781-5380
Fax: 615-781-5391

May 17, 2006
Mr. William Shirley, Jr., Owner
Louisiana.DBA Riegel By-Products
2621 State Street
Dallas, Texas 75204
Dear Mr. Shirley:
On February 12, 17, 21, and 22, 2006, a U.S. Food & Drug Administration
(FDA) investigator inspected your rendering plant, located at 509 Fortson
Street, Shreveport, Louisiana. The inspection revealed significant
deviations from the requirements set forth in Title 21, Code of Federal
Regulations, Part 589.2000 [21 CFR 589.2000], Animal Proteins Prohibited in
Ruminant Feed. This regulation is intended to prevent the establishment and
amplification of Bovine Spongiform Encephalopathy (BSE). You failed to
follow the requirements of this regulation; products being manufactured and
distributed by your facility are misbranded within the meaning of Section
403(a)(1) [21 USC 343(a)(1)] of the Federal Food, Drug, and Cosmetic Act
(the Act).
Our investigation found you failed to provide measures, including sufficient
written procedures, to prevent commingling or cross-contamination and to
maintain sufficient written procedures [21 CFR 589.2000(e)] because:
You failed to use clean-out procedures or other means adequate to prevent
carryover of protein derived from mammalian tissues into animal protein or
feeds which may be used for ruminants. For example, your facility uses the
same equipment to process mammalian and poultry tissues. However, you use
only hot water to clean the cookers between processing tissues from each
species. You do not clean the auger, hammer mill, grinder, and spouts after
processing mammalian tissues.
You failed to maintain written procedures specifying the clean-out
procedures or other means to prevent carryover of protein derived from
mammalian tissues into feeds which may be used for ruminants.
As a result . the poultry meal you manufacture may contain protein derived
from mammalian tissues prohibited in ruminant feed. Pursuant to 21 CFR
589.2000(e)(1)(i), any products containing or may contain protein derived
from mammalian tissues must be labeled, "Do not feed to cattle or other
ruminants." Since you failed to label a product which may contain protein
derived from mammalian tissues with the required cautionary statement. the
poultry meal is misbranded under Section 403(a)(1) [21 USC 343(a)(1)] of the
This letter is not intended as an all-inclusive list of violations at your
facility. As a manufacturer of materials intended for animal feed use, you
are responsible for ensuring your overall operation and the products you
manufacture and distribute are in compliance with the law. You should take
prompt action to correct these violations, and you should establish a system
whereby violations do not recur. Failure to promptly correct these
violations may result in regulatory action, such as seizure and/or
injunction, without further notice.
You should notify this office in writing within 15 working days of receiving
this letter, outlining the specific steps you have taken to bring your firm
into compliance with the law. Your response should include an explanation of
each step taken to correct the violations and prevent their recurrence. If
corrective action cannot be completed within 15 working days, state the
reason for the delay and the date by which the corrections will be
completed. Include copies of any available documentation demonstrating
corrections have been made.
Your reply should be directed to Mark W. Rivero, Compliance Officer, U.S.
Food and Drug Administration, 2424 Edenborn Avenue, Suite 410, Metairie,
Louisiana 70001. If you have questions regarding any issue in this letter,
please contact Mr. Rivero at (504) 219-8818, extension 103.
Carol S. Sanchez
Acting District Director
New Orleans District

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

Risk of oral infection with bovine spongiform encephalopathy agent in

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

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


BSE bovine brain inoculum
100 g 10 g 5 g 1 g 100 mg 10 mg 1 mg 0·1 mg 0·01 mg
Primate (oral route)* 1/2 (50%)
Cattle (oral route)* 10/10 (100%) 7/9 (78%) 7/10 (70%) 3/15 (20%) 1/15 (7%)
1/15 (7%)
RIII mice (ic ip route)* 17/18 (94%) 15/17 (88%) 1/14 (7%)
PrPres biochemical detection
The comparison is made on the basis of calibration of the bovine inoculum
used in our study with primates against a bovine brain inoculum with a
similar PrPres concentration that was
inoculated into mice and cattle.8 *Data are number of animals
positive/number of animals surviving at the time of clinical onset of
disease in the first positive animal (%). The accuracy of
bioassays is generally judged to be about plus or minus 1 log. ic
ip=intracerebral and intraperitoneal.
Table 1: Comparison of transmission rates in primates and cattle infected
orally with similar BSE brain inocula

Published online January 27, 2005

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

[Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk
Materials for Human Food and Requirement for the Disposition of
Non-Ambulatory Disabled Cattle



9 December 2005
Division of Dockets Management (RFA-305)

James J. Kramer, Ph.D.
Vice President, Corporate Operations

Embassy of Japan


still sadly disgusted,

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

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