Subject: Substances Prohibited from Use in Animal Food or Feed, Proposed Rule, Docket No. 2002N-0273 C-534 VOL 45 (PhRMA) and Entered On February 17, 2006
Date: March 10, 2006 at 5:23 pm PST
Marie A. Vodicka, PhD
Assistant Vice President
Biologics & Blotechnology
Scientlflc & Regulatory Affairs
SCIENCE & REG AFFAIRS
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rrn . 1061
Rackville, MD 20862
Re: Substances Prohibited from Use in Animal Food or Feed, Proposed Rule, Docket
No. 2002N-0273
February 14, 2006
Dear Sir or Madam :
The Pharmaceutical Research and Manufacturers of America (PhRMA) is providing
comment to the proposed rules issued. by the Food and Drug Administration (FDA)
Center for Veterinary Medicine (CVM) entitled Substances Prohibited From Use in
Animal Food or Feed ; Proposed Rule, 21 CFR Part 589; 70 Federal Register 58570
(October 6, 2005). PhRMA applauds the FDA's continued actions to protect the cattle
population of the United States from BSE (bovine spongiform encephalopat.hy) and, as
discussed further below, strongly supports additional safeguards in addition to those
proposed in amended 21 CFR Part 589_
PhRMA represents the country's leading research-based pharmaceutical and
biotechnology companies, which are devoted to inventing medicines that allow patients
to lead longer, healthier and more productive lives. Investing more than $30 billion
annually in discovering and developing new medicines, PhRMA companies are leading
the way in the search for cures .
Animal-derived materials are ubiquitous in our lives and have many important uses .
They are often used in pharmaceutical manufacturing and are sourced according to
Pharmaceutical Research and Manufacturers of America
Page 2of7
guidelines issued by regulatory authorities and the specifications outlined by the quality
systems of the pharmaceutical company. The BSE status of the country where the
animal lived and an assessment of the controls in place to prevent the spread of the
disease, if it should occur, are important considerations in sourcing bovine-derived
materials . While a country may have animals diagnosed with BSE, evaluation of the
measures put in place to halt the spread of the disease is as crucial as identification of
the disease itself. PhRMA continues to support an internationally harmonized, sciencebased
approach to determining appropriate safeguards against BSE. PhRMA believes
that FDA efforts to communicate these science-based concepts to our trading partners
worldwide are critical. It is just as important to institute sound science-based policies in
order to stop the spread of disease.
Consideration of the safeguards enacted in the various countries where ruminant derived
raw materials are sourced provides the underpinning for regulatory guidance.
The cattle population of the United States must continue to be an acceptable source of
bovine-derived raw materials for human food and pharmaceutical manufacturing. As
such, continual re-evaluation of existing safeguards against BSE must occur based on
new information and advances in science . Due to confirmation that BSE is indeed
present in North America, rapid implementation of enhanced safeguards for cattle and
animal feed is required .
We continue to be concerned about the amount of time it has taken the Center for
veterinary Medicine (CVM) to institute any changes to the 1997 feed ban; a lot has
happened since 1997, not the least of which is the identification of a BSE cow native to
the United States (June 2004). As we have urged for many years, the 1997 feed ban
must be enhanced based on new information, including the experimental results that
Page 3 of 7
show as little as 0.001 gram of infected tissue fed orally to cattle may result in BSE
infection of cattle1.
PhRMA supports actions of the Food and Drug Administration Center for Veterinary
Medicine (FDA CVM ) to extend certain provisions in the 1997 Ruminant to Ruminant
feed ban to all animal feed . As noted in the 1997 ruminant feed final rule (§ 589.2000)
and described in the October 6, 2005 Federal Register notice,2 the use of mammalian
derived proteins is currently prohibited in ruminant feed, with the exception of certain
proteins believed not to pose a risk of BSE transmission . These exceptions to the
definition of "protein derived from mammalian tissues" include: blood and blood
products; gelatin; inspected meat products which have been cooked and offered for
human food and further heat processed for feed (such as plate waste and used
cellulosic food casings), referred to herein as "plate waste" ; milk products (milk and
milk protein) ; and any product whose only mammalian protein consists entirely of
porcine or equine protein. The 1997 ruminant feed final rule does not prohibit ruminant
animals from being fed processed animal proteins derived from non-mammalian
species (e .g ., avian or aquatic animals). The 1997 ruminant feed final rule permits the
manufacture of non-ruminant feed containing prohibited mammalian protein and
ruminant feed on the same premises, provided that separate equipment is used in the
production of ruminant feed or that documented adequate clean-out procedures are
used between production batches .
PhRMA has commented numerous times on the inadequacy of the 1997 feed ban (our
latest comments were provided to Federal Register Docket 2004N-0264 and dated
August 12, 2004). We stated that the current exemptions in the feed ban must be
http://www.defra.gov.uk/animalh/bse/science-research/pathog.html#dose
" Federal Register. Docket 20Gi2N-0273_ Vol. 70, No. 193 58570-58601 . Part IZi, Department of Health and Human Services, FDA 21CFR5$9 Subsianecs Prohlbired from Use ill Animal Food or Feed; Proposed Rule
Page 4 of 7
critically examined in light of the identification of BSE positive animals in Canada,
Washington, and subsequently in Texas. Over the last few years, PhRMA has urged
that serious consideration be given to prohibiting all specified risk material (SRM) in
rendered product used for non-ruminant feed due to the potential for "on farm" cross
contamination with feed designated for ruminants . We have strongly recommended
implementation of measures to ensure that SRM is excluded from all animal feed . In
addition, PhRMA urged the complete removal of the exception for ruminant blood and
the exemptions for plate waste and poultry litter from the ruminant feed ban. As such,
we strongly support the current FDA position to eliminate SRM from all animal feed and
urge its immediate implementation. This safeguard must be implemented rapidly.
Regrettably, FDA proposes to eliminate only the brain and spinal cord from cattle 30
months of age or older, not the complete list of SRMs currently designated for human
food . Given the absence of a species barrier when non-ruminant feed is fed
(inadvertently or deliberately) to ruminants, we urge the FDA to reconsider its position
and eliminate the complete list of SRM from all animal feed.
We are steadfast in our position urging the removal of the exemption for plate waste
and poultry litter . This position is based on the lack of species barrier and the inclusion
of tissues with potentially high levels of infectivity present in plate waste and poultry
litter . Allowing the exception for plate waste provides a direct route for feeding
ruminants to ruminants because plate waste may contain uneaten food items such as
T-bone steak waste, including bone innervated with dorsal root ganglia (DRG). The
absence of a species barrier when feeding ruminants to ruminants would facilitate the
transmission of infectivity by the demonstrated high titer DRG, if infectivity were
present . We have evaluated the rationale provide by FDA CVM for not banning plate
waste (in summary: SRMs are prohibited in human food therefore plate waste will not
contain SRMs and can be fed back to cattle). This rationale does not take into account
the lack of a species barrier when feeding cattle plate waste containing beef. The lack
Page 5 of 7
of a species barrier, coupled with the definition of SRMs limited to cows over 30 months
of age, combined with the knowledge that there is circulating BSE agent (albeit at
exceedingly low levels) in North America, are strong reasons to completely ban the
feeding of plate waste to bovines . In addition, the FDA states in the proposed rules that
they do not have an estimate of the amount of plate waste added to bovine feed, but
the available anecdotal information states that the amount is not significant. If there is
only a limited amount of plate waste being processed to bovine feed, given the lack of
species barrier, it appears logical to prohibit the use of plate waste completely. PhRMA
does not agree that eliminating all plate waste from bovine feed is an 'unnecessary
measure' and we strongly urge CVM to reevaluate its position.
Both specified risk materials (SRM) and plate waste are currently allowed in poultry
feed. We recommend that both SRM and plate waste be removed from poultry feed so
that poultry litter can be used as a bovine nitrogen source. If these materials are not
removed from poultry feed, then we recommend that poultry litter be banned from the
diet of cattle.
The proposed rule contains a provision to utilize certain dead cattle in animal feed.
Allowing deadstock (dead, down, disabled, diseased) into the animal food chain if the
brain and spinal cords have been removed does not take into account that these
animals are the most likely to harbor infectivity as symptoms of BSE disease confound
the segregation of these animals. The total amount of infectivity does not reside in the
brain and spinal cord and removal of these tissues does not make the remainder of the
carcass acceptable to process into animal feed . According to risk assessment models,
adult cattle deadstock are the population harboring the majority of the potential
Page 6 of 7
infectivity if BSE were! circulating in a population 3. Elimination of the deadstock from the
animal food chain is critical to prevent the spread of disease.
The other exemptions in the 1997 feed ban such as blood and milk/milk products are
less problematic as Iong as milk and blood are sourced to prevent cross-contamination
with high infiectivity tissues. We agree with the FDA's approach to these two tissues if
the potential for cross-contamination is minimized .
In summary, we recognize the tremendous efforts CVM has expended on defining a
strategy for enhanced feed controls in the United States to help stop the spread of
BSE. The thoughtful evaluation of all comments as a result of the publication of the
Advance Notice of Public Rule Making (July 14, 2004) reflects an Agency attempting to
balance the risks of continuing current feeding practices with the practical
considerations of various industries . We appreciate a risk based approach but have
misgivings about the level of safeguards contained in the proposed rule.
To reiterate, our main concerns center on the following three issues - the narrow
definition of the SRM to be excluded from non-ruminant feed, instead of a complete ban
as for ruminant feed; the continued allowance of plate waste and poultry litter in
ruminant feed and finally, the provision to allow certain deadstock cattle into the animal
food chain .
PhRMA appreciates the opportunity to comment on the proposed changes to the
ruminant feed ban and the implementation of controls on non-ruminant feed_ PhRMA
member companies manufacture human medicines using a wide variety of materials .
We continue to source animal derived raw materials according to regulations of FDA
Page 7 of 7
and the quality systems of the company. The United States must continue to be
recognized as an acceptable source of these animal derived raw materials both
domestically and by our international trading partners . Using sound science to
influence regulatory approaches to animal husbandry is the key to preventing the
spread of BSE in the United States. FDA and USDA have already done a lot to protect
the United States but more must be done as reflected in our comments herein . Please
contact me if you have any questions or would like to arrange a meeting to discuss our
comments.
Sincerely,
Marie A. Vodicka, PhD
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000534-01-vol45.pdf
Subject: Docket No: 2002N-0273 (formerly Docket No. 02N-0273) Substances Prohibited From Use in Animal Food and Feed PAUL BROWN
Date: January 20, 2006 at 9:31 am PST
December 20,2005
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000490-vol40.pdf
McDonalds Dick Crawford
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273_emc-000134-02.pdf
THE SEVEN SCIENTIST REPORT ***
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-EC244-Attach-1.pdf
pharmaceutical supplier Seriologicals Corp.
9 December 2005
snip...
9 December 2005
Division of Dockets Management (RFA-305)
Food and Drug Administration
5630 Fishers Lane
Room 1061
Rockville, MD 20852
Re: Docket No: 2002N-0273 (formerly Docket No. 02N-0273)
Substances Prohibited From Use in Animal Food and Feed
Dear Sir or Madame:
Serologicals Corporation is a global provider of biological products to life
science companies.
The Company's products are essential for the research, development and
manufacturing of
biologically based diagnostic, pharmaceutical and biological products.
customers include
many of the leading research institutions, diagnostic and pharmaceutical
companies throughout
the world. The Company's products and technologies are used in a wide
variety of applications
within the areas of neurobiology, cell signaling, oncology, angiogenesis,
apoptosis,
developmental biology, cellular physiology, hematology, immunology,
cardiology, infectious
diseases and molecular biology.
A number of our products are derived from bovine blood or other bovine
tissues sourced in the
United States, hence the overall health of the national herd is extremely
important to our
company as well as to our customers and their patients. Some of our bovine
based products are
used in the manufacture of vaccines and drugs for humans, hence it is
critical that all measures
are taken to assure these are safe and free from disease especially Bovine
Spongiform
Encephalopathy (BSE). The most effective way to insure this is to create a
system which
processes cattle that are BSE free. ...
snip...
The current proposed rule falls short of this and would still leave a
potential source of infectivity
in the system. In fact by the FDA's own statement the exempted tissues which
are known to
have infectivity (such as distal ileum, DRGs, etc) would cumulatively amount
to 10% of the
infectivity in an infected animal, This proposed rule would still allow for
the possibility that
cattle could be exposed to BSE through:
1. Feeding of materials currently subject to legal exemptions from the ban
(e.g., poultry
litter, plate waste)
2. Cross feeding (the feeding of non-ruminant rations to ruminants) on
farms; and
3. Cross contamination of ruminant and non-ruminant feed
We are most concerned that the FDA has chosen to include a provision which
would allow
tissues from deadstock into the feed chain. We do not support the provision
to allow the removal
of brain and spinal cord from down and deadstock over 30 months of age for
several reasons.
These are the animals with the highest level of infectivity in tissues which
include more than
brain and spinal cord. We do not feel that there can be adequate removal and
enforcement of this
regulation especially during warmer weather. In addition there is emerging
information that at
end stage disease, infectivity may also be included in additionai tissues
such as peripheral nerves
(Buschmann and Groschup, 2005).
Leaving the tissues from these cattle in the animal feed chain will
effectively nullify the intent of
this regulation. This point is illustrated by the 2001 Harvard risk
assessment model which
demonstrated that eliminating dead and downer, 4D cattle, from the feed
stream was a
disproportionately effective means of reducing the risk of re-infection "The
disposition of c&e
that die on the farm would also have a substantial influence on the spread
of BSE if the disease
were in traduced. ...
snip...
Respectfully,
SEROLOGICALS CORPORATION
James J. Kramer, Ph.D.
Vice President, Corporate Operations
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000383-01-vol35.pdf
Date: Tue, 10 Jan 2006 09:39:57 -0600
Reply-To: Bovine Spongiform Encephalopathy
Sender: Bovine Spongiform Encephalopathy
From: "Terry S. Singeltary Sr."
Subject: MAD COW FEED BAN WARNING LETTER December 21, 2005
##################### Bovine Spongiform Encephalopathy #####################
Subject: MAD COW FEED BAN WARNING LETTER December 21, 2005
Date: January 10, 2006 at 7:18 am PST
Public Health Service
Food and Drug Administration
Kansas City District
Southwest Region
11630 West 80th Street
Lenexa, Kansas 66214-3340
December 21, 2005
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
Ref. KAN 2006-08
Mr. Paul Rasmussen, President
Gold Eagle Cooperative Board of Directors
1145 Birch Ave
Corwith, IA 50430
Dear Mr. Rasmussen:
An investigator from our office conducted two inspections of your animal feed manufacturing operations at 415 N. Locust St., Goldfield, Iowa on August 23 and August 25 -26, 2005. During these inspections, a significant deviation from the requirements set forth in Title 21, Code of Federal Regulations (CFR), Part 589 .2000 [21 CFR 589 .2000] - Animal Proteins Prohibited in Ruminant Feed, was identified . The regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Our investigation found a failure to label one of your products, "ISLACT - IS LACTATION," a swine feed, with the statement "Do Not Feed to Cattle or Other Ruminants," as required by 21 CFR 589 .2000(d) . Although your swine feed is not formulated with protein derived from mammalian tissues as defined in 21 CFR 589 .2000(a)(1), which is prohibited in ruminant feed, your production practices may cause the finished product to contain such material. Our investigator found that your firm does not have a strategy for sequencing feeds and does not flush or otherwise clean shared production equipment between the manufacture of poultry feed formulated with protein derived from mammalian tissues and swine feed formulated without such material . As a result, swine feed may acquire protein derived from mammalian tissue from poultry feed residue remaining on the shared production equipment. Your failure to label your "ISLACT - IS LACTATION" swine feed with the statement "Do Not Feed to Cattle or Other Ruminants" causes it to be misbranded under section 403(a)(1) of the Act.
The above is not intended to be an all-inclusive list of deficiencies at your facility. As a manufacturer of animal feed, you are responsible for ensuring that your overall operation and the products you manufacture and distribute comply with the law.
You should take prompt action to correct this violation and establish a system whereby such violations do not recur. Failure to promptly correct this violation may result in regulatory action, such as seizure and/or injunction, without further notice.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include an explanation of each step being taken to correct the violation and prevent its recurrence. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the date by which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Please send your reply to the Food and Drug Administration, Attention: Ralph Gray, Compliance Officer, 11630 West 80th Street, Lenexa, KS 66214-3340.
Sincerely,
/s/
C.R. Pendleton for John W. Thorsky
District Director
Kansas City District
http://www.fda.gov/foi/warning_letters/g5668d.htm
[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
03-025IFA
03-025IFA-2
Terry S. Singeltary
Page 1 of 17
From: Terry S. Singeltary Sr. [[email protected]]
Sent: Thursday, September 08, 2005 6:17 PM
To: [email protected].
Subject: [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirements
for the Disposition of Non-Ambulatory Disabled Cattle
Greetings FSIS,
I would kindly like to submit the following to [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and
Requirements for the Disposition of Non-Ambulatory Disabled Cattle
THE BSE/TSE SUB CLINICAL Non-Ambulatory Disabled Cattle
Broken bones and such may be the first signs of a sub clinical BSE/TSE Non-Ambulatory Disabled Cattle ;
SUB CLINICAL PRION INFECTION
MRC-43-00
Issued: Monday, 28 August 2000
NEW EVIDENCE OF SUB-CLINICAL PRION INFECTION: IMPORTANT RESEARCH
FINDINGS RELEVANT TO CJD AND BSE
Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518
9/13/2005
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf
Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW BSE SAFEGUARDS (comment submission)
https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument
Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL
IMPORTS FROM CANADA
https://web01.aphis.usda.gov/BSEcom.nsf/0/b78ba677e2b0c12185256dd300649f9d?OpenDocument&AutoFramed
Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION]
http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt
Docket Management Docket: 02N-0273 - Substances Prohibited From Use in
Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
Comment Number: EC -10
Accepted - Volume 2
http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html
PART 2
http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be09.html
Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION
TO DOCKET 2003N-0312]
http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt
PDF]Freas, William TSS SUBMISSION
File Format: PDF/Adobe Acrobat -
Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary
Sr. [[email protected]] Monday, January 08,200l 3:03 PM freas ...
http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf
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
http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm
Docket: 02N-0276 - Bioterrorism Preparedness; Registration of Food Facilities, Section 305
Comment Number: EC-254 [TSS SUBMISSION]
snip...
Greetings list members,
i just cannot accept this;
> 23 kg of meat in a suitcase (suitcase bomb...TSS)
> The data do not provide a species of origin code for these
> products, therefore they may not contain any ruminant product. what kind of statement is this?
how stupid do they think we are? it could also very well mean that _all_ of it was ruminant based products !
snip...
Greetings FDA and public, if you go to the below site, and search all BSE known countries and check out their air traffic illegal meat they have confiscated, and check out the low number checked, compared to actual passenger traffic, would not take too much for some nut to bring in FMD/TSEs into the USA as a 'suitcase bomb'.
[[Under APHIS-PPQ's agricultural quarantine inspection monitoring, 284 air passengers from Israel were sampled for items of agricultural interest in fiscal year 2001. Seven of these passengers, or 2 percent, carried a total of 11 kg of meat items that could potentially harbor the pathogen that causes BSE. None of these passengers from whom meat items were confiscated reported plans to visit or work on a ranch or farm during their visit to the U.S.]]
if they were to have questioned the terrorist that bombed the Twin Towers with jets, if they were to have questioned them at flight school in the USA, i am sure that they would have said they did not intend to visit the Twin Towers as a flying bomb either. what am i thinking, they probably did ask this? stupid me.
[[In 1999 a small amount of non-species specific meat and offal was imported and a small amount of fetal bovine serum (FBS) was also imported. FBS is considered to have a relatively low risk of transmitting BSE.]]
more of the USA infamous 'non-species coding system', wonder how many of these species are capable of carrying a TSE?
snip...
Greetings again List Members, let me kick a madcow around here a bit. on the imports from Poland and the infamous USA 'non-species' coding system. the USDA/APHIS states;
> During the past four years (1998 - 2001), US imports from
> Poland included non-species specific animal products
> used in animal feeds and non-species specific sausage and offal
> products (Table 3). Given US restrictions on ruminant product
> imports, these US imports should not have contained ruminant
> material.
NOW, if you read Polands GBR risk assessment and opinion on BSE, especially _cross-contamination_, it states;
ANNEX 1 Poland - Summary of the GBR-Assessment, February 2001 EXTERNAL CHALLENGE STABILITY INTERACTION OF EXTERNAL CHALLENGE AND STABILITY The very high to extremely high external challenge met a very unstable system and could have led to contamination of domestic cattle in Poland from 1987 onwards. This internal challenge again met the still very unstable system and increased over time. The continuing very high external challenge supported this development. Not OK MBM-ban since 1997, but no feed controls. Reasonably OK Heat treatment equivalent to 133°C / 20min / 3 bar standards, but no evidence provided on compliance. Not OK. No SRM-ban, SRM are rendered and included in cattle feed. BSE surveillance: Not sufficient before 2001. Cross-contamination: Lines for ruminant and non-ruminant feed in feed-mills only separated in time and no analytical controls carried out. Likely present since 1987 and growing. see full text and ANNEX 1 at;
http://europa.eu.int/comm/food/fs/sc/ssc/out185_en.pdf
so in my humble opinion, the statement by the USDA/APHIS that ''these US imports _should_ not have contained ruminant materials, is a joke. a sad joke indeed. * POLAND BSE GBR RISK ASSESSMENT
http://europa.eu.int/comm/food/fs/sc/ssc/out185_en.pdf
snip...
full text;
http://www.fda.gov/ohrms/dockets/dockets/02n0276/02N-0276-EC-254.htm
2006 POLAND BSE
Subject: Poland Bse and animal nutrition & bse, scrapie testing Member States
Date: February 8, 2006 at 10:58 am PST
01/2006 Poland Bse and animal nutrition 7693-2005
http://europa.eu.int/comm/food/fvo/act_getPDF.cfm?PDF_ID=4951
Annexes
http://europa.eu.int/comm/food/fvo/act_getPDFannx.cfm?ANX_ID=4540
http://europa.eu.int/comm/food/fvo/act_getPDFannx.cfm?ANX_ID=4541
Subject: New case of mad cow disease in Poland
Date: December 28, 2005 at 10:20 am PST
AFX News Limited
New case of mad cow disease in Poland
12.28.2005, 02:36 AM
WARSAW (AFX) - A new case of bovine spongiform encephalopathy (BSE), or mad cow disease, has been detected in Poland, the country's veterinary service said.
The head of the national veterinary service, Krzysztof Jazdzewski, said that the infected animal was found on a farm in the northwest of the country and had been put down.
'The disease was detected on a farm with a total of 18 animals. Eight of them have been identified as exposed to risk (of contamination) and have been killed,' he said.
There have been more than 22 cases of mad cow disease in Poland since it began testing for BSE in 2001.
[email protected]
afp/jsa
http://www.forbes.com/afxnewslimited/feeds/afx/2005/12/28/afx2416658.html
TSS 2001
Subject: BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001
Date: Tue, 9 Jan 2001 16:49:00 -0800
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: [email protected]
######### 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
so.
"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.
[TSS]
yes, thank you,
U.S. cattle, what kind of guarantee can you
give for serum or tissue donor herds?
[no answer, you could hear in the back ground,
mumbling and 'we can't. have him ask the question
again.]
[host Richard]
could you repeat the question?
[TSS]
U.S. cattle, what kind of guarantee can you
give for serum or tissue donor herds?
[not sure whom ask this]
what group are you with?
[TSS]
CJD Watch, my Mom died from hvCJD and we are
tracking CJD world-wide.
[not sure who is speaking]
could you please disconnect Mr. Singeltary
[TSS]
you are not going to answer my question?
[not sure whom speaking]
NO
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?
[TSS]
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;
[email protected]
301-827-6906
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
appearing.
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
occurred.
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'
56 FIRMS NEVER INSPECTED
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
owners.
THE END
TSS
############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html
############
FROM New York TIMES
Subject: Re: BSE 50 STATE CONFERENCE CALL thread from BSE List and FDA
Posting of cut version...
Date: Thu, 11 Jan 2001 22:02:47 -0700
From: "Sandy Blakeslee"
To: "Terry S. Singeltary Sr."
References: 1
Hi terry -- thanks for all your help. I know it made a difference with
the FDA getting out that release.
From the New York Times NYTimes.com, January 11, 2001
Many Makers of Feed Fail to Heed Rules on Mad Cow Disease
By SANDRA BLAKESLEE
Large numbers of companies involved in manufacturing animal feed are not
complying with regulations meant to prevent the
emergence and spread of mad cow disease in the United States, the Food
and Drug Administration said yesterday.
The widespread failure of companies to follow the regulations, adopted
in August 1997, does not mean that the American food supply is unsafe,
Dr. Stephen Sundlof, director of the Center for Veterinary Medicine at
the F.D.A., said in an interview.
But much more needs to be done to ensure that mad cow disease does not
arise in this country, Dr. Sundlof said.
The regulations state that feed manufacturers and companies that render
slaughtered animals into useful products generally may not feed mammals
to cud-chewing animals, or ruminants, which can carry mad cow disease.
All products that contain rendered cattle or sheep must have a label
that says, "Do not feed to ruminants," Dr. Sundlof said. Manufacturers
must also have a system to prevent ruminant products from being
commingled with other rendered material like that from chicken, fish or
pork. Finally, all companies must keep records of where their products
originated and where they were sold.
Under the regulations, F.D.A. district offices and state veterinary
offices were required to inspect all rendering plants and feed mills to
make sure companies complied. But results issued yesterday demonstrate
that more than three years later, different segments of the feed
industry show varying levels of compliance.
Among 180 large companies that render cattle and another ruminant,
sheep, nearly a quarter were not properly labeling their products and
did not have a system to prevent commingling, the F.D.A. said. And among
347 F.D.A.-licensed feed mills that handle ruminant materials - these
tend to be large operators that mix drugs into their products - 20
percent were not using labels with the required caution statement, and
25 percent did not have a system to prevent commingling.
Then there are some 6,000 to 8,000 feed mills so small they do not
require F.D.A. licenses. They are nonetheless subject
to the regulations, and of 1,593 small feed producers that handle
ruminant material and have been inspected, 40 percent
were not using approved labels and 25 percent had no system in place to
prevent commingling.
On the other hand, fewer than 10 percent of companies, big and small,
were failing to comply with the record-keeping
regulations.
The American Feed Industry Association in Arlington, Va., did not return
phone calls seeking comment.
http://www.nytimes.com/2001/01/11/science/11COW.html
Subject:
USDA/APHIS response to BSE-L--U.S. 50 STATE CONFERENCE CALL
Jan. 9, 2001
Date:
Wed, 10 Jan 2001 14:04:21 -0500
From:
"Gomez, Thomas M."
Reply-To:
Bovine Spongiform Encephalopathy
To:
[email protected]
######### Bovine Spongiform Encephalopathy
#########
USDA/APHIS would like to provide clarification on the following point
from
Mr. Singeltary's 9 Jan posting regarding the 50 state conference call.
[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']
Dr. Detwiler was responding to an announcement made during the call to
use
the FDA emergency number if anyone wanted to report a cow with signs
suspect
for BSE. Mr. Singeltary is correct that Dr. Detwiler asked participants
to
use the FDA emergency number as a last resort to report cattle suspect
for
BSE. What Mr. Singeltary failed to do was provide the List with Dr.
Detwiler's entire statement. Surveillance for BSE in the United States
is a
cooperative effort between states, producers, private veterinarians,
veterinary hospitals and the USDA. The system has been in place for
over 10
years. Each state has a system in place wherein cases are reported to
either the State Veterinarian, the federal Veterinarian in Charge or
through
the veterinary diagnostic laboratory system. The states also have
provisions with emergency numbers. Dr. Detwiler asked participants to
use
the systems currently in place to avoid the possibility of a BSE-suspect
report falling through the cracks. Use of the FDA emergency number has
not
been established as a means to report diseased cattle of any nature.
############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html
############
Subject:
Re: USDA/APHIS response to BSE-L--U.S. 50 STATE CONFERENCE
CALL Jan.9, 2001
Date:
Wed, 10 Jan 2001 13:44:49 -0800
From:
"Terry S. Singeltary Sr."
Reply-To:
Bovine Spongiform Encephalopathy
To:
[email protected]
References:
1
######### Bovine Spongiform Encephalopathy
#########
Hello Mr. Thomas,
> What Mr. Singeltary failed to do was provide
> the List with Dr. Detwiler's entire statement.
would you and the USDA/APHIS be so kind as to supply
this list with a full text version of the conference
call and or post on your web-site?
if so when, and thank you.
if not, why not?
> The system has been in place for over 10 years.
that seems to be a very long time for a system to be in
place, and only test 10,700 cattle from some 1.5 BILLION head (including
calf crop). Especially since French
are testing some 20,000 weekly and the E.U. as a whole,
are testing many many more than the U.S., with less
cattle, same risk of BSE/TSEs.
Why does the U.S. insist on not doing massive testing
with the tests which the E.U. are using?
Why is this, please explain?
Please tell me why my question was not answered?
> U.S. cattle, what kind of guarantee can you
> give for serum or tissue donor herds?
It was a very simple question, a very important
question, one that pertained to the topic of
BSE/feed, and asked in a very diplomatic way.
why was it not answered?
If all these years, we have been hearing that
pharmaceutical grade bovines were raised for
pharmaceuticals vaccines etc. But yet the
USA cannot comply with feed regulations of
the ruminant feed ban, PLUS cannot even
comply with the proper labelling of the feed,
cross contamination etc.
Then how in the world can you Guarantee the feed
fed to pharmaceutical grade bovine, were actually
non ruminant feed?
Before i was ask to be 'disconnected',
i did hear someone in the background
say 'we can't'-- have him ask the question again.
could you please be so kind, as to answer these
questions?
thank you,
Terry S. Singeltary Sr. Bacliff, Texas USA
P.S. if you will also notice, i did not post that
emergency phone number and do not intend on passing
it on to anyone. I was joking when i said i should
call and report the whole damn U.S. Herd. So please
pass that on to Dr. Detwiler, so she can rest easily.
BUT, they should be reported, some are infected with TSE.
The U.S. is just acting as stupid as Germany and other
Countries that insist they are free of BSE.
TSS
----- Original Message -----
From: "Terry S. Singeltary Sr."
To:
Sent: Thursday, January 11, 2001 2:06 PM
Subject: BSE 50 STATE CONFERENCE CALL thread from BSE List and FDA
Posting of cut version...SNIP...END
Date: March 10, 2006 at 5:23 pm PST
Marie A. Vodicka, PhD
Assistant Vice President
Biologics & Blotechnology
Scientlflc & Regulatory Affairs
SCIENCE & REG AFFAIRS
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rrn . 1061
Rackville, MD 20862
Re: Substances Prohibited from Use in Animal Food or Feed, Proposed Rule, Docket
No. 2002N-0273
February 14, 2006
Dear Sir or Madam :
The Pharmaceutical Research and Manufacturers of America (PhRMA) is providing
comment to the proposed rules issued. by the Food and Drug Administration (FDA)
Center for Veterinary Medicine (CVM) entitled Substances Prohibited From Use in
Animal Food or Feed ; Proposed Rule, 21 CFR Part 589; 70 Federal Register 58570
(October 6, 2005). PhRMA applauds the FDA's continued actions to protect the cattle
population of the United States from BSE (bovine spongiform encephalopat.hy) and, as
discussed further below, strongly supports additional safeguards in addition to those
proposed in amended 21 CFR Part 589_
PhRMA represents the country's leading research-based pharmaceutical and
biotechnology companies, which are devoted to inventing medicines that allow patients
to lead longer, healthier and more productive lives. Investing more than $30 billion
annually in discovering and developing new medicines, PhRMA companies are leading
the way in the search for cures .
Animal-derived materials are ubiquitous in our lives and have many important uses .
They are often used in pharmaceutical manufacturing and are sourced according to
Pharmaceutical Research and Manufacturers of America
Page 2of7
guidelines issued by regulatory authorities and the specifications outlined by the quality
systems of the pharmaceutical company. The BSE status of the country where the
animal lived and an assessment of the controls in place to prevent the spread of the
disease, if it should occur, are important considerations in sourcing bovine-derived
materials . While a country may have animals diagnosed with BSE, evaluation of the
measures put in place to halt the spread of the disease is as crucial as identification of
the disease itself. PhRMA continues to support an internationally harmonized, sciencebased
approach to determining appropriate safeguards against BSE. PhRMA believes
that FDA efforts to communicate these science-based concepts to our trading partners
worldwide are critical. It is just as important to institute sound science-based policies in
order to stop the spread of disease.
Consideration of the safeguards enacted in the various countries where ruminant derived
raw materials are sourced provides the underpinning for regulatory guidance.
The cattle population of the United States must continue to be an acceptable source of
bovine-derived raw materials for human food and pharmaceutical manufacturing. As
such, continual re-evaluation of existing safeguards against BSE must occur based on
new information and advances in science . Due to confirmation that BSE is indeed
present in North America, rapid implementation of enhanced safeguards for cattle and
animal feed is required .
We continue to be concerned about the amount of time it has taken the Center for
veterinary Medicine (CVM) to institute any changes to the 1997 feed ban; a lot has
happened since 1997, not the least of which is the identification of a BSE cow native to
the United States (June 2004). As we have urged for many years, the 1997 feed ban
must be enhanced based on new information, including the experimental results that
Page 3 of 7
show as little as 0.001 gram of infected tissue fed orally to cattle may result in BSE
infection of cattle1.
PhRMA supports actions of the Food and Drug Administration Center for Veterinary
Medicine (FDA CVM ) to extend certain provisions in the 1997 Ruminant to Ruminant
feed ban to all animal feed . As noted in the 1997 ruminant feed final rule (§ 589.2000)
and described in the October 6, 2005 Federal Register notice,2 the use of mammalian
derived proteins is currently prohibited in ruminant feed, with the exception of certain
proteins believed not to pose a risk of BSE transmission . These exceptions to the
definition of "protein derived from mammalian tissues" include: blood and blood
products; gelatin; inspected meat products which have been cooked and offered for
human food and further heat processed for feed (such as plate waste and used
cellulosic food casings), referred to herein as "plate waste" ; milk products (milk and
milk protein) ; and any product whose only mammalian protein consists entirely of
porcine or equine protein. The 1997 ruminant feed final rule does not prohibit ruminant
animals from being fed processed animal proteins derived from non-mammalian
species (e .g ., avian or aquatic animals). The 1997 ruminant feed final rule permits the
manufacture of non-ruminant feed containing prohibited mammalian protein and
ruminant feed on the same premises, provided that separate equipment is used in the
production of ruminant feed or that documented adequate clean-out procedures are
used between production batches .
PhRMA has commented numerous times on the inadequacy of the 1997 feed ban (our
latest comments were provided to Federal Register Docket 2004N-0264 and dated
August 12, 2004). We stated that the current exemptions in the feed ban must be
http://www.defra.gov.uk/animalh/bse/science-research/pathog.html#dose
" Federal Register. Docket 20Gi2N-0273_ Vol. 70, No. 193 58570-58601 . Part IZi, Department of Health and Human Services, FDA 21CFR5$9 Subsianecs Prohlbired from Use ill Animal Food or Feed; Proposed Rule
Page 4 of 7
critically examined in light of the identification of BSE positive animals in Canada,
Washington, and subsequently in Texas. Over the last few years, PhRMA has urged
that serious consideration be given to prohibiting all specified risk material (SRM) in
rendered product used for non-ruminant feed due to the potential for "on farm" cross
contamination with feed designated for ruminants . We have strongly recommended
implementation of measures to ensure that SRM is excluded from all animal feed . In
addition, PhRMA urged the complete removal of the exception for ruminant blood and
the exemptions for plate waste and poultry litter from the ruminant feed ban. As such,
we strongly support the current FDA position to eliminate SRM from all animal feed and
urge its immediate implementation. This safeguard must be implemented rapidly.
Regrettably, FDA proposes to eliminate only the brain and spinal cord from cattle 30
months of age or older, not the complete list of SRMs currently designated for human
food . Given the absence of a species barrier when non-ruminant feed is fed
(inadvertently or deliberately) to ruminants, we urge the FDA to reconsider its position
and eliminate the complete list of SRM from all animal feed.
We are steadfast in our position urging the removal of the exemption for plate waste
and poultry litter . This position is based on the lack of species barrier and the inclusion
of tissues with potentially high levels of infectivity present in plate waste and poultry
litter . Allowing the exception for plate waste provides a direct route for feeding
ruminants to ruminants because plate waste may contain uneaten food items such as
T-bone steak waste, including bone innervated with dorsal root ganglia (DRG). The
absence of a species barrier when feeding ruminants to ruminants would facilitate the
transmission of infectivity by the demonstrated high titer DRG, if infectivity were
present . We have evaluated the rationale provide by FDA CVM for not banning plate
waste (in summary: SRMs are prohibited in human food therefore plate waste will not
contain SRMs and can be fed back to cattle). This rationale does not take into account
the lack of a species barrier when feeding cattle plate waste containing beef. The lack
Page 5 of 7
of a species barrier, coupled with the definition of SRMs limited to cows over 30 months
of age, combined with the knowledge that there is circulating BSE agent (albeit at
exceedingly low levels) in North America, are strong reasons to completely ban the
feeding of plate waste to bovines . In addition, the FDA states in the proposed rules that
they do not have an estimate of the amount of plate waste added to bovine feed, but
the available anecdotal information states that the amount is not significant. If there is
only a limited amount of plate waste being processed to bovine feed, given the lack of
species barrier, it appears logical to prohibit the use of plate waste completely. PhRMA
does not agree that eliminating all plate waste from bovine feed is an 'unnecessary
measure' and we strongly urge CVM to reevaluate its position.
Both specified risk materials (SRM) and plate waste are currently allowed in poultry
feed. We recommend that both SRM and plate waste be removed from poultry feed so
that poultry litter can be used as a bovine nitrogen source. If these materials are not
removed from poultry feed, then we recommend that poultry litter be banned from the
diet of cattle.
The proposed rule contains a provision to utilize certain dead cattle in animal feed.
Allowing deadstock (dead, down, disabled, diseased) into the animal food chain if the
brain and spinal cords have been removed does not take into account that these
animals are the most likely to harbor infectivity as symptoms of BSE disease confound
the segregation of these animals. The total amount of infectivity does not reside in the
brain and spinal cord and removal of these tissues does not make the remainder of the
carcass acceptable to process into animal feed . According to risk assessment models,
adult cattle deadstock are the population harboring the majority of the potential
Page 6 of 7
infectivity if BSE were! circulating in a population 3. Elimination of the deadstock from the
animal food chain is critical to prevent the spread of disease.
The other exemptions in the 1997 feed ban such as blood and milk/milk products are
less problematic as Iong as milk and blood are sourced to prevent cross-contamination
with high infiectivity tissues. We agree with the FDA's approach to these two tissues if
the potential for cross-contamination is minimized .
In summary, we recognize the tremendous efforts CVM has expended on defining a
strategy for enhanced feed controls in the United States to help stop the spread of
BSE. The thoughtful evaluation of all comments as a result of the publication of the
Advance Notice of Public Rule Making (July 14, 2004) reflects an Agency attempting to
balance the risks of continuing current feeding practices with the practical
considerations of various industries . We appreciate a risk based approach but have
misgivings about the level of safeguards contained in the proposed rule.
To reiterate, our main concerns center on the following three issues - the narrow
definition of the SRM to be excluded from non-ruminant feed, instead of a complete ban
as for ruminant feed; the continued allowance of plate waste and poultry litter in
ruminant feed and finally, the provision to allow certain deadstock cattle into the animal
food chain .
PhRMA appreciates the opportunity to comment on the proposed changes to the
ruminant feed ban and the implementation of controls on non-ruminant feed_ PhRMA
member companies manufacture human medicines using a wide variety of materials .
We continue to source animal derived raw materials according to regulations of FDA
Page 7 of 7
and the quality systems of the company. The United States must continue to be
recognized as an acceptable source of these animal derived raw materials both
domestically and by our international trading partners . Using sound science to
influence regulatory approaches to animal husbandry is the key to preventing the
spread of BSE in the United States. FDA and USDA have already done a lot to protect
the United States but more must be done as reflected in our comments herein . Please
contact me if you have any questions or would like to arrange a meeting to discuss our
comments.
Sincerely,
Marie A. Vodicka, PhD
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000534-01-vol45.pdf
Subject: Docket No: 2002N-0273 (formerly Docket No. 02N-0273) Substances Prohibited From Use in Animal Food and Feed PAUL BROWN
Date: January 20, 2006 at 9:31 am PST
December 20,2005
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000490-vol40.pdf
McDonalds Dick Crawford
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273_emc-000134-02.pdf
THE SEVEN SCIENTIST REPORT ***
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-EC244-Attach-1.pdf
pharmaceutical supplier Seriologicals Corp.
9 December 2005
snip...
9 December 2005
Division of Dockets Management (RFA-305)
Food and Drug Administration
5630 Fishers Lane
Room 1061
Rockville, MD 20852
Re: Docket No: 2002N-0273 (formerly Docket No. 02N-0273)
Substances Prohibited From Use in Animal Food and Feed
Dear Sir or Madame:
Serologicals Corporation is a global provider of biological products to life
science companies.
The Company's products are essential for the research, development and
manufacturing of
biologically based diagnostic, pharmaceutical and biological products.
customers include
many of the leading research institutions, diagnostic and pharmaceutical
companies throughout
the world. The Company's products and technologies are used in a wide
variety of applications
within the areas of neurobiology, cell signaling, oncology, angiogenesis,
apoptosis,
developmental biology, cellular physiology, hematology, immunology,
cardiology, infectious
diseases and molecular biology.
A number of our products are derived from bovine blood or other bovine
tissues sourced in the
United States, hence the overall health of the national herd is extremely
important to our
company as well as to our customers and their patients. Some of our bovine
based products are
used in the manufacture of vaccines and drugs for humans, hence it is
critical that all measures
are taken to assure these are safe and free from disease especially Bovine
Spongiform
Encephalopathy (BSE). The most effective way to insure this is to create a
system which
processes cattle that are BSE free. ...
snip...
The current proposed rule falls short of this and would still leave a
potential source of infectivity
in the system. In fact by the FDA's own statement the exempted tissues which
are known to
have infectivity (such as distal ileum, DRGs, etc) would cumulatively amount
to 10% of the
infectivity in an infected animal, This proposed rule would still allow for
the possibility that
cattle could be exposed to BSE through:
1. Feeding of materials currently subject to legal exemptions from the ban
(e.g., poultry
litter, plate waste)
2. Cross feeding (the feeding of non-ruminant rations to ruminants) on
farms; and
3. Cross contamination of ruminant and non-ruminant feed
We are most concerned that the FDA has chosen to include a provision which
would allow
tissues from deadstock into the feed chain. We do not support the provision
to allow the removal
of brain and spinal cord from down and deadstock over 30 months of age for
several reasons.
These are the animals with the highest level of infectivity in tissues which
include more than
brain and spinal cord. We do not feel that there can be adequate removal and
enforcement of this
regulation especially during warmer weather. In addition there is emerging
information that at
end stage disease, infectivity may also be included in additionai tissues
such as peripheral nerves
(Buschmann and Groschup, 2005).
Leaving the tissues from these cattle in the animal feed chain will
effectively nullify the intent of
this regulation. This point is illustrated by the 2001 Harvard risk
assessment model which
demonstrated that eliminating dead and downer, 4D cattle, from the feed
stream was a
disproportionately effective means of reducing the risk of re-infection "The
disposition of c&e
that die on the farm would also have a substantial influence on the spread
of BSE if the disease
were in traduced. ...
snip...
Respectfully,
SEROLOGICALS CORPORATION
James J. Kramer, Ph.D.
Vice President, Corporate Operations
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000383-01-vol35.pdf
Date: Tue, 10 Jan 2006 09:39:57 -0600
Reply-To: Bovine Spongiform Encephalopathy
Sender: Bovine Spongiform Encephalopathy
From: "Terry S. Singeltary Sr."
Subject: MAD COW FEED BAN WARNING LETTER December 21, 2005
##################### Bovine Spongiform Encephalopathy #####################
Subject: MAD COW FEED BAN WARNING LETTER December 21, 2005
Date: January 10, 2006 at 7:18 am PST
Public Health Service
Food and Drug Administration
Kansas City District
Southwest Region
11630 West 80th Street
Lenexa, Kansas 66214-3340
December 21, 2005
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
Ref. KAN 2006-08
Mr. Paul Rasmussen, President
Gold Eagle Cooperative Board of Directors
1145 Birch Ave
Corwith, IA 50430
Dear Mr. Rasmussen:
An investigator from our office conducted two inspections of your animal feed manufacturing operations at 415 N. Locust St., Goldfield, Iowa on August 23 and August 25 -26, 2005. During these inspections, a significant deviation from the requirements set forth in Title 21, Code of Federal Regulations (CFR), Part 589 .2000 [21 CFR 589 .2000] - Animal Proteins Prohibited in Ruminant Feed, was identified . The regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Our investigation found a failure to label one of your products, "ISLACT - IS LACTATION," a swine feed, with the statement "Do Not Feed to Cattle or Other Ruminants," as required by 21 CFR 589 .2000(d) . Although your swine feed is not formulated with protein derived from mammalian tissues as defined in 21 CFR 589 .2000(a)(1), which is prohibited in ruminant feed, your production practices may cause the finished product to contain such material. Our investigator found that your firm does not have a strategy for sequencing feeds and does not flush or otherwise clean shared production equipment between the manufacture of poultry feed formulated with protein derived from mammalian tissues and swine feed formulated without such material . As a result, swine feed may acquire protein derived from mammalian tissue from poultry feed residue remaining on the shared production equipment. Your failure to label your "ISLACT - IS LACTATION" swine feed with the statement "Do Not Feed to Cattle or Other Ruminants" causes it to be misbranded under section 403(a)(1) of the Act.
The above is not intended to be an all-inclusive list of deficiencies at your facility. As a manufacturer of animal feed, you are responsible for ensuring that your overall operation and the products you manufacture and distribute comply with the law.
You should take prompt action to correct this violation and establish a system whereby such violations do not recur. Failure to promptly correct this violation may result in regulatory action, such as seizure and/or injunction, without further notice.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include an explanation of each step being taken to correct the violation and prevent its recurrence. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the date by which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Please send your reply to the Food and Drug Administration, Attention: Ralph Gray, Compliance Officer, 11630 West 80th Street, Lenexa, KS 66214-3340.
Sincerely,
/s/
C.R. Pendleton for John W. Thorsky
District Director
Kansas City District
http://www.fda.gov/foi/warning_letters/g5668d.htm
[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
03-025IFA
03-025IFA-2
Terry S. Singeltary
Page 1 of 17
From: Terry S. Singeltary Sr. [[email protected]]
Sent: Thursday, September 08, 2005 6:17 PM
To: [email protected].
Subject: [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirements
for the Disposition of Non-Ambulatory Disabled Cattle
Greetings FSIS,
I would kindly like to submit the following to [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and
Requirements for the Disposition of Non-Ambulatory Disabled Cattle
THE BSE/TSE SUB CLINICAL Non-Ambulatory Disabled Cattle
Broken bones and such may be the first signs of a sub clinical BSE/TSE Non-Ambulatory Disabled Cattle ;
SUB CLINICAL PRION INFECTION
MRC-43-00
Issued: Monday, 28 August 2000
NEW EVIDENCE OF SUB-CLINICAL PRION INFECTION: IMPORTANT RESEARCH
FINDINGS RELEVANT TO CJD AND BSE
Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518
9/13/2005
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf
Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW BSE SAFEGUARDS (comment submission)
https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument
Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL
IMPORTS FROM CANADA
https://web01.aphis.usda.gov/BSEcom.nsf/0/b78ba677e2b0c12185256dd300649f9d?OpenDocument&AutoFramed
Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION]
http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt
Docket Management Docket: 02N-0273 - Substances Prohibited From Use in
Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
Comment Number: EC -10
Accepted - Volume 2
http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html
PART 2
http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be09.html
Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION
TO DOCKET 2003N-0312]
http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt
PDF]Freas, William TSS SUBMISSION
File Format: PDF/Adobe Acrobat -
Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary
Sr. [[email protected]] Monday, January 08,200l 3:03 PM freas ...
http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf
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
http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm
Docket: 02N-0276 - Bioterrorism Preparedness; Registration of Food Facilities, Section 305
Comment Number: EC-254 [TSS SUBMISSION]
snip...
Greetings list members,
i just cannot accept this;
> 23 kg of meat in a suitcase (suitcase bomb...TSS)
> The data do not provide a species of origin code for these
> products, therefore they may not contain any ruminant product. what kind of statement is this?
how stupid do they think we are? it could also very well mean that _all_ of it was ruminant based products !
snip...
Greetings FDA and public, if you go to the below site, and search all BSE known countries and check out their air traffic illegal meat they have confiscated, and check out the low number checked, compared to actual passenger traffic, would not take too much for some nut to bring in FMD/TSEs into the USA as a 'suitcase bomb'.
[[Under APHIS-PPQ's agricultural quarantine inspection monitoring, 284 air passengers from Israel were sampled for items of agricultural interest in fiscal year 2001. Seven of these passengers, or 2 percent, carried a total of 11 kg of meat items that could potentially harbor the pathogen that causes BSE. None of these passengers from whom meat items were confiscated reported plans to visit or work on a ranch or farm during their visit to the U.S.]]
if they were to have questioned the terrorist that bombed the Twin Towers with jets, if they were to have questioned them at flight school in the USA, i am sure that they would have said they did not intend to visit the Twin Towers as a flying bomb either. what am i thinking, they probably did ask this? stupid me.
[[In 1999 a small amount of non-species specific meat and offal was imported and a small amount of fetal bovine serum (FBS) was also imported. FBS is considered to have a relatively low risk of transmitting BSE.]]
more of the USA infamous 'non-species coding system', wonder how many of these species are capable of carrying a TSE?
snip...
Greetings again List Members, let me kick a madcow around here a bit. on the imports from Poland and the infamous USA 'non-species' coding system. the USDA/APHIS states;
> During the past four years (1998 - 2001), US imports from
> Poland included non-species specific animal products
> used in animal feeds and non-species specific sausage and offal
> products (Table 3). Given US restrictions on ruminant product
> imports, these US imports should not have contained ruminant
> material.
NOW, if you read Polands GBR risk assessment and opinion on BSE, especially _cross-contamination_, it states;
ANNEX 1 Poland - Summary of the GBR-Assessment, February 2001 EXTERNAL CHALLENGE STABILITY INTERACTION OF EXTERNAL CHALLENGE AND STABILITY The very high to extremely high external challenge met a very unstable system and could have led to contamination of domestic cattle in Poland from 1987 onwards. This internal challenge again met the still very unstable system and increased over time. The continuing very high external challenge supported this development. Not OK MBM-ban since 1997, but no feed controls. Reasonably OK Heat treatment equivalent to 133°C / 20min / 3 bar standards, but no evidence provided on compliance. Not OK. No SRM-ban, SRM are rendered and included in cattle feed. BSE surveillance: Not sufficient before 2001. Cross-contamination: Lines for ruminant and non-ruminant feed in feed-mills only separated in time and no analytical controls carried out. Likely present since 1987 and growing. see full text and ANNEX 1 at;
http://europa.eu.int/comm/food/fs/sc/ssc/out185_en.pdf
so in my humble opinion, the statement by the USDA/APHIS that ''these US imports _should_ not have contained ruminant materials, is a joke. a sad joke indeed. * POLAND BSE GBR RISK ASSESSMENT
http://europa.eu.int/comm/food/fs/sc/ssc/out185_en.pdf
snip...
full text;
http://www.fda.gov/ohrms/dockets/dockets/02n0276/02N-0276-EC-254.htm
2006 POLAND BSE
Subject: Poland Bse and animal nutrition & bse, scrapie testing Member States
Date: February 8, 2006 at 10:58 am PST
01/2006 Poland Bse and animal nutrition 7693-2005
http://europa.eu.int/comm/food/fvo/act_getPDF.cfm?PDF_ID=4951
Annexes
http://europa.eu.int/comm/food/fvo/act_getPDFannx.cfm?ANX_ID=4540
http://europa.eu.int/comm/food/fvo/act_getPDFannx.cfm?ANX_ID=4541
Subject: New case of mad cow disease in Poland
Date: December 28, 2005 at 10:20 am PST
AFX News Limited
New case of mad cow disease in Poland
12.28.2005, 02:36 AM
WARSAW (AFX) - A new case of bovine spongiform encephalopathy (BSE), or mad cow disease, has been detected in Poland, the country's veterinary service said.
The head of the national veterinary service, Krzysztof Jazdzewski, said that the infected animal was found on a farm in the northwest of the country and had been put down.
'The disease was detected on a farm with a total of 18 animals. Eight of them have been identified as exposed to risk (of contamination) and have been killed,' he said.
There have been more than 22 cases of mad cow disease in Poland since it began testing for BSE in 2001.
[email protected]
afp/jsa
http://www.forbes.com/afxnewslimited/feeds/afx/2005/12/28/afx2416658.html
TSS 2001
Subject: BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001
Date: Tue, 9 Jan 2001 16:49:00 -0800
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: [email protected]
######### 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
so.
"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.
[TSS]
yes, thank you,
U.S. cattle, what kind of guarantee can you
give for serum or tissue donor herds?
[no answer, you could hear in the back ground,
mumbling and 'we can't. have him ask the question
again.]
[host Richard]
could you repeat the question?
[TSS]
U.S. cattle, what kind of guarantee can you
give for serum or tissue donor herds?
[not sure whom ask this]
what group are you with?
[TSS]
CJD Watch, my Mom died from hvCJD and we are
tracking CJD world-wide.
[not sure who is speaking]
could you please disconnect Mr. Singeltary
[TSS]
you are not going to answer my question?
[not sure whom speaking]
NO
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?
[TSS]
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;
[email protected]
301-827-6906
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
appearing.
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
occurred.
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'
56 FIRMS NEVER INSPECTED
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
owners.
THE END
TSS
############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html
############
FROM New York TIMES
Subject: Re: BSE 50 STATE CONFERENCE CALL thread from BSE List and FDA
Posting of cut version...
Date: Thu, 11 Jan 2001 22:02:47 -0700
From: "Sandy Blakeslee"
To: "Terry S. Singeltary Sr."
References: 1
Hi terry -- thanks for all your help. I know it made a difference with
the FDA getting out that release.
From the New York Times NYTimes.com, January 11, 2001
Many Makers of Feed Fail to Heed Rules on Mad Cow Disease
By SANDRA BLAKESLEE
Large numbers of companies involved in manufacturing animal feed are not
complying with regulations meant to prevent the
emergence and spread of mad cow disease in the United States, the Food
and Drug Administration said yesterday.
The widespread failure of companies to follow the regulations, adopted
in August 1997, does not mean that the American food supply is unsafe,
Dr. Stephen Sundlof, director of the Center for Veterinary Medicine at
the F.D.A., said in an interview.
But much more needs to be done to ensure that mad cow disease does not
arise in this country, Dr. Sundlof said.
The regulations state that feed manufacturers and companies that render
slaughtered animals into useful products generally may not feed mammals
to cud-chewing animals, or ruminants, which can carry mad cow disease.
All products that contain rendered cattle or sheep must have a label
that says, "Do not feed to ruminants," Dr. Sundlof said. Manufacturers
must also have a system to prevent ruminant products from being
commingled with other rendered material like that from chicken, fish or
pork. Finally, all companies must keep records of where their products
originated and where they were sold.
Under the regulations, F.D.A. district offices and state veterinary
offices were required to inspect all rendering plants and feed mills to
make sure companies complied. But results issued yesterday demonstrate
that more than three years later, different segments of the feed
industry show varying levels of compliance.
Among 180 large companies that render cattle and another ruminant,
sheep, nearly a quarter were not properly labeling their products and
did not have a system to prevent commingling, the F.D.A. said. And among
347 F.D.A.-licensed feed mills that handle ruminant materials - these
tend to be large operators that mix drugs into their products - 20
percent were not using labels with the required caution statement, and
25 percent did not have a system to prevent commingling.
Then there are some 6,000 to 8,000 feed mills so small they do not
require F.D.A. licenses. They are nonetheless subject
to the regulations, and of 1,593 small feed producers that handle
ruminant material and have been inspected, 40 percent
were not using approved labels and 25 percent had no system in place to
prevent commingling.
On the other hand, fewer than 10 percent of companies, big and small,
were failing to comply with the record-keeping
regulations.
The American Feed Industry Association in Arlington, Va., did not return
phone calls seeking comment.
http://www.nytimes.com/2001/01/11/science/11COW.html
Subject:
USDA/APHIS response to BSE-L--U.S. 50 STATE CONFERENCE CALL
Jan. 9, 2001
Date:
Wed, 10 Jan 2001 14:04:21 -0500
From:
"Gomez, Thomas M."
Reply-To:
Bovine Spongiform Encephalopathy
To:
[email protected]
######### Bovine Spongiform Encephalopathy
#########
USDA/APHIS would like to provide clarification on the following point
from
Mr. Singeltary's 9 Jan posting regarding the 50 state conference call.
[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']
Dr. Detwiler was responding to an announcement made during the call to
use
the FDA emergency number if anyone wanted to report a cow with signs
suspect
for BSE. Mr. Singeltary is correct that Dr. Detwiler asked participants
to
use the FDA emergency number as a last resort to report cattle suspect
for
BSE. What Mr. Singeltary failed to do was provide the List with Dr.
Detwiler's entire statement. Surveillance for BSE in the United States
is a
cooperative effort between states, producers, private veterinarians,
veterinary hospitals and the USDA. The system has been in place for
over 10
years. Each state has a system in place wherein cases are reported to
either the State Veterinarian, the federal Veterinarian in Charge or
through
the veterinary diagnostic laboratory system. The states also have
provisions with emergency numbers. Dr. Detwiler asked participants to
use
the systems currently in place to avoid the possibility of a BSE-suspect
report falling through the cracks. Use of the FDA emergency number has
not
been established as a means to report diseased cattle of any nature.
############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html
############
Subject:
Re: USDA/APHIS response to BSE-L--U.S. 50 STATE CONFERENCE
CALL Jan.9, 2001
Date:
Wed, 10 Jan 2001 13:44:49 -0800
From:
"Terry S. Singeltary Sr."
Reply-To:
Bovine Spongiform Encephalopathy
To:
[email protected]
References:
1
######### Bovine Spongiform Encephalopathy
#########
Hello Mr. Thomas,
> What Mr. Singeltary failed to do was provide
> the List with Dr. Detwiler's entire statement.
would you and the USDA/APHIS be so kind as to supply
this list with a full text version of the conference
call and or post on your web-site?
if so when, and thank you.
if not, why not?
> The system has been in place for over 10 years.
that seems to be a very long time for a system to be in
place, and only test 10,700 cattle from some 1.5 BILLION head (including
calf crop). Especially since French
are testing some 20,000 weekly and the E.U. as a whole,
are testing many many more than the U.S., with less
cattle, same risk of BSE/TSEs.
Why does the U.S. insist on not doing massive testing
with the tests which the E.U. are using?
Why is this, please explain?
Please tell me why my question was not answered?
> U.S. cattle, what kind of guarantee can you
> give for serum or tissue donor herds?
It was a very simple question, a very important
question, one that pertained to the topic of
BSE/feed, and asked in a very diplomatic way.
why was it not answered?
If all these years, we have been hearing that
pharmaceutical grade bovines were raised for
pharmaceuticals vaccines etc. But yet the
USA cannot comply with feed regulations of
the ruminant feed ban, PLUS cannot even
comply with the proper labelling of the feed,
cross contamination etc.
Then how in the world can you Guarantee the feed
fed to pharmaceutical grade bovine, were actually
non ruminant feed?
Before i was ask to be 'disconnected',
i did hear someone in the background
say 'we can't'-- have him ask the question again.
could you please be so kind, as to answer these
questions?
thank you,
Terry S. Singeltary Sr. Bacliff, Texas USA
P.S. if you will also notice, i did not post that
emergency phone number and do not intend on passing
it on to anyone. I was joking when i said i should
call and report the whole damn U.S. Herd. So please
pass that on to Dr. Detwiler, so she can rest easily.
BUT, they should be reported, some are infected with TSE.
The U.S. is just acting as stupid as Germany and other
Countries that insist they are free of BSE.
TSS
----- Original Message -----
From: "Terry S. Singeltary Sr."
To:
Sent: Thursday, January 11, 2001 2:06 PM
Subject: BSE 50 STATE CONFERENCE CALL thread from BSE List and FDA
Posting of cut version...SNIP...END