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From: TSS ()
Subject: Re: McDonald's Corp. seven scientists and experts and a pharmaceutical supplier Seriologicals Corp. U.S. NOT PROTECTED AGAINST MAD COW DISEASE
Date: January 5, 2006 at 2:44 pm PST

In Reply to: McDonald's Corp. seven scientists and experts and a pharmaceutical supplier Seriologicals Corp. U.S. NOT PROTECTED AGAINST MAD COW DISEASE posted by TSS on January 4, 2006 at 3:15 pm:

Greetings,

see below my comments this and more;


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:

snip...


but first;


i seem to be having a relaps today. my opinions are taking me over. i must comment and therefore will probably brake my 2006 resolution.


i thought i might look up some of the submissions by the industry to various docket submissions about BSE. talk about corporate science and BSe$ some of these folks are determined to continue to spread this agent it seems, just for a profit, and i think it's just that for the most part, they are oblivious to the 'sound science' and are stuck in the 'fabricated science' USDA/FDA et al has been feeding them since the 'partial' and 'voluntary' r-t-r feed ban was put into place 8/4/97. i sat in on the infamous jan. 9, 2001, 50 state BSE emergency conference call, and the same thing was very evident then, the industry was oblivious to the science and the real facts. hell, most did not even know about the feed ban. and reading in 2006 some of the submissions made in nov. and dec. 2005 to the 2002N-0273 Animal Proteins Prohibited in Ruminant Feed docket i submitted to 2003-01-15 13:55:02, but some of these people still go by the terribly flawed 'USA Gold Standard' of the 'bought and paid for by your local cattle dealer's Harvard BSE risk assessment, which like i said was proven flawed by a board of 'TSE EXPERTS' from around the globe ;


THE SUPPRESSED PEER REVIEW OF THE HARVARD BSE RISK ASSESSMENT study October 31, 2002 132 PAGES

http://www.fsis.usda.gov/oa/topics/BSE_Peer_Review.pdf


I really believe that some of these Gov. agencies and some of these industry are starting to see the light a bit, and want to go to a true 'sound science' based approach, the science is catching up, they see it, BUT, the Gov agencies have fed the industry so much BSe over the years, they now cannot make them believe the truth, the 'sound science'. maybe huh??? ......................na.....im dreaming now.


NOT to mention what everyone FAILS to mention, the fact that the USA, CANADA, AND MEXICO GBR BSE RISK ASSESSMENT was raised to a risk level of BSE GBR III July 2004;

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of the United States of America (USA)
Publication date: 20 August 2004
Adopted July 2004 (Question N° EFSA-Q-2003-083)

Report

Summary
Summary of the Scientific Report

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

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

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

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


http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/573_en.html

SUMMARY

Summary of Scientific Report
http://www.efsa.eu.int
1 of 1
Scientific Report of the European Food Safety Authority
on the Assessment of the Geographical BSE-Risk (GBR) of
United States of America (USA)
Question N° EFSA-Q-2003-083
Adopted July 2004
Summary of scientific report
The European Food Safety Authority and its Scientific Expert Working Group on the
Assessment of the Geographical Bovine Spongiform Encephalopathy (BSE) Risk (GBR)
were asked by the European Commission (EC) to provide an up-to-date scientific report on
the GBR in the United States of America, i.e. the likelihood of the presence of one or more
cattle being infected with BSE, pre-clinically as well as clinically, in USA. This scientific
report addresses the GBR of USA as assessed in 2004 based on data covering the period
1980-2003.
The BSE agent was probably imported into USA and could have reached domestic cattle in
the middle of the eighties. These cattle imported in the mid eighties could have been rendered
in the late eighties and therefore led to an internal challenge in the early nineties. It is possible
that imported meat and bone meal (MBM) into the USA reached domestic cattle and leads to
an internal challenge in the early nineties.
A processing risk developed in the late 80s/early 90s when cattle imports from BSE risk
countries were slaughtered or died and were processed (partly) into feed, together with some
imports of MBM. This risk continued to exist, and grew significantly in the mid 90’s when
domestic cattle, infected by imported MBM, reached processing. Given the low stability of
the system, the risk increased over the years with continued imports of cattle and MBM from
BSE risk countries.
EFSA concludes that the current GBR level of USA is III, i.e. it is likely but not confirmed
that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent. As long as
there are no significant changes in rendering or feeding, the stability remains extremely/very
unstable. Thus, the probability of cattle to be (pre-clinically or clinically) infected with the
BSE-agent persistently increases.
Key words: BSE, geographical risk assessment, GBR, USA, third countries

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/573/sr03_biohaz02_usa_report_summary_en1.pdf

REPORT (6 PAGES)

snip...

EFSA Scientific Report (2004) 3, 1-6 on the Assessment of the Geographical BSE Risk of
Conclusions
The European Food Safety Authority concludes:
1. The BSE agent was probably imported into USA and could have reached domestic
cattle in the middle of the eighties. This cattle imported in the mid eighties could have
been rendered in the late eighties and therefore led to an internal challenge in the early
nineties. It is possible that meat and bone meal (MBM) imported into the USA
reached domestic cattle and lead to an internal challenge in the early nineties.
2. A processing risk developed in the late 80s/early 90s when cattle imports from BSE
risk countries were slaughtered or died and were processed (partly) into feed, together
with some imports of MBM. This risk continued to exist, and grew significantly in the
mid 90’s when domestic cattle, infected by imported MBM, reached processing.
Given the low stability of the system, the risk increased over the years with continued
imports of cattle and MBM from BSE risk countries.
3. The current geographical BSE risk (GBR) level is III, i.e. it is likely but not confirmed
that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent.
4. This assessment deviates from the previous assessment (SSC opinion, 2000) because
at that time several exporting countries were not considered a potential risk.
5. It is also worth noting that the current GBR conclusions are not dependent on the large
exchange of imports between USA and Canada. External challenge due to exports to
the USA from European countries varied from moderate to high. These challenges
indicate that it was likely that BSE infectivity was introduced into the North American
continent.
6. EFSA and its Scientific Expert Working group on GBR are concerned that the
available information was not confirmed by inspection missions as performed by the
Food and Veterinary office (FVO – DG SANCO) in Member States and other third
countries. They recommend including, as far as feasible, BSE-related aspects in
future inspection missions.
Expected development of the GBR
As long as there are no significant changes in rendering or feeding, the stability remains
extremely/very unstable. Thus, the probability of cattle to be (pre-clinically or clinically)
infected with the BSE-agent persistently increases.
A table summarising the reasons for the current assessment is given in the table below

snip...

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/573/sr03_biohaz02_usa_report_v2_en1.pdf


EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of Mexico
Last updated: 08 September 2004
Adopted July 2004 (Question N° EFSA-Q-2003-083)

Report

http://www.efsa.eu.int
3 of 6
Conclusions
The European Food Safety Authority concludes:
1. The BSE agent was probably imported into Mexico and could have reached domestic
cattle. These cattle imported could have been rendered and therefore led to an internal
EFSA Scientific Report (2004) 4, 1-6 on the Assessment of the Geographical BSE Risk of
challenge in the mid to late 1990’s. It is possible that imported MBM into Mexico
reached domestic cattle and leads to an internal challenge around 1993.
2. It is likely that BSE infectivity entered processing at the time of imported ‘at - risk’
MBM (1993) and at the time of slaughter of imported live ‘at - risk’ cattle (mid to late
1990s). The high level of external challenge is maintained throughout the reference
period, and the system has not been made stable. Thus it is likely that BSE infectivity
was recycled and propagated from approximately 1993. The risk has since grown
consistently due to a maintained internal and external challenge and lack of a stable
system.
3. The current geographical BSE risk (GBR) level is III, i.e. it is likely but not confirmed
that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent.
4. EFSA and its Scientific Expert Working group on GBR are concerned that the
available information was not confirmed by inspection missions as performed by the
Food and Veterinary office (FVO – DG SANCO) in Member States and other third
countries. They recommend including, as far as feasible, BSE-related aspects in
future inspection missions.

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/565/sr04_biohaz02_mexico_report_v2_en1.pdf

Summary

Summary of Scientific Report
http://www.efsa.eu.int
1 of 2
Scientific Report of the European Food Safety Authority
on the Assessment of the Geographical BSE-Risk (GBR) of
MEXICO
Question N° EFSA-Q-2003-083
Adopted July 2004
SUMMARY OF SCIENTIFIC REPORT
The European Food Safety Authority and its Scientific Expert Working Group on the
Assessment of the Geographical Bovine Spongiform Encephalopathy (BSE) Risk (GBR)
were asked by the European Commission (EC) to provide an up-to-date scientific report on
the GBR in Mexico, i.e. the likelihood of the presence of one or more cattle being infected
with BSE, pre-clinically as well as clinically, in Mexico. This scientific report addresses the
GBR of Mexico as assessed in 2004 based on data covering the period 1980-2003.
The BSE agent was probably imported into Mexico and could have reached domestic cattle.
These cattle imported could have been rendered and therefore led to an internal challenge in
the mid to late 1990s. It is possible that imported meat and bone meal (MBM) into Mexico
reached domestic cattle and leads to an internal challenge around 1993.
It is likely that BSE infectivity entered processing at the time of imported ‘at - risk’ MBM
(1993) and at the time of slaughter of imported live ‘at - risk’ cattle (mid to late 1990s). The
high level of external challenge is maintained throughout the reference period, and the system
has not been made stable. Thus it is likely that BSE infectivity was recycled and propagated
from approximately 1993. The risk has since grown consistently due to a maintained internal
and external challenge and lack of a stable system.
EFSA concludes that the current geographical BSE risk (GBR) level is III, i.e. it is likely
but not confirmed that domestic cattle are (clinically or pre-clinically) infected with the BSEagent.
The GBR is likely to increase due to continued internal and external challenge, coupled
with a very unstable system.
Key words: BSE, geographical risk assessment, GBR, Mexico, third countries
Summary of Scientific Report
http://www.efsa.eu.int
2 of 2


http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/565/sr04_biohaz02_mexico_report_summary_en1.pdf


Summary of the Scientific Report

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

The BSE agent was probably imported into Mexico and could have reached domestic cattle. These cattle imported could have been rendered and therefore led to an internal challenge in the mid to late 1990s. It is possible that imported meat and bone meal (MBM) into Mexico reached domestic cattle and leads to an internal challenge around 1993.

It is likely that BSE infectivity entered processing at the time of imported ‘at - risk’ MBM (1993) and at the time of slaughter of imported live ‘at - risk’ cattle (mid to late 1990s). The high level of external challenge is maintained throughout the reference period, and the system has not been made stable. Thus it is likely that BSE infectivity was recycled and propagated from approximately 1993. The risk has since grown consistently due to a maintained internal and external challenge and lack of a stable system.

EFSA concludes that the current geographical BSE risk (GBR) level is III, i.e. it is likely but not confirmed that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent. The GBR is likely to increase due to continued internal and external challenge, coupled with a very unstable system.

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/565_en.html


CANADA

3.3 Overall assessment of the stability

For the overall assessment of the stability, the impact of the three main stability factors

(i.e. feeding, rendering and SRM-removal) and of the additional stability factor,

surveillance, has to be estimated. Again, the guidance provided by the SSC in its

opinion on the GBR of July 2000 (as updated January 2002) is applied.

Feeding

Until 1997, it was legally possible to feed ruminant MBM to cattle and a certain fraction of

cattle feed (for calves and dairy cattle) is assumed to have contained MBM. Therefore

feeding was "Not OK". In August 1997 a ruminant MBM ban was introduced but feeding

of non-ruminant MBM to cattle remained legal as well as feeding of ruminant MBM to

non-ruminant animals. This makes control of the feed ban very difficult because laboratory

differentiation between ruminant and non ruminant MBM is difficult if not impossible.

Annex to the EFSA Scientific Report (2004) 2, 1-15 on the Assessment of the

Geographical BSE Risk of Canada

Due to the highly specialised production system in Canada, various mammalian MBM

streams can be separated. Such a feed ban would therefore be assessed as "reasonably

OK", for all regions where this highly specialised system exists. However, several areas

in Canada do have mixed farming and mixed feed mills, and in such regions, an RMBM

ban would not suffice. Additionally, official controls for cattle feeds to control for the

compliance with the ban were not started until the end of 2003. Thus, for the whole

country, the assessment of the feeding after 1997 remains "Not OK".

Rendering

The rendering industry is operating with processes that are not known to reduce infectivity.

It is therefore concluded that the rendering was and is "Not OK".

SRM-removal

SRM and fallen stock were and are rendered for feed. Therefore SRM-removal is assessed

as "Not OK"

snip...

4.2 Risk that BSE infectivity entered processing

A certain risk that BSE-infected cattle entered processing in Canada, and were at least

partly rendered for feed, occurred in the early 1990s when cattle imported from UK in

the mid 80s could have been slaughtered. This risk continued to exist, and grew

significantly in the mid 90’s when domestic cattle, infected by imported MBM, reached

processing. Given the low stability of the system, the risk increased over the years with

continued imports of cattle and MBM from BSE risk countries.

4.3 Risk that BSE infectivity was recycled and propagated

A risk that BSE-infectivity was recycled and propagated exists since a processing risk

first appeared; i.e. in the early 90s. Until today this risk persists and increases fast

because of the extremely unstable BSE/cattle system in Canada.

5. CONCLUSION ON THE GEOGRAPHICAL BSE-RISK

5.1 The current GBR as function of the past stability and challenge

The current geographical BSE-risk (GBR) level is III, i.e. it is confirmed at a lower level

that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent.

This assessment deviates from the previous assessment (SSC opinion, 2000) because at

that time several exporting countries were not considered a potential risk.

snip...

full text;


http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/563/sr02_biohaz02_canada_report_annex_en1.pdf


ONE YEAR PREVIOUSLY ;

From: Terry S. Singeltary Sr. [flounder@wt.net]
Sent: Tuesday, July 29, 2003 1:03 PM
To: fdadockets@oc.fda.gov
Cc: ggraber@cvm.fda.gov; Linda.Grassie@fda.gov; BSE-L
Subject: Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION
TO DOCKET 2003N-0312]

Greetings FDA,

snip...

PLUS, if the USA continues to flagrantly ignore the _documented_ science to date about the known TSEs in the USA (let alone the undocumented TSEs in cattle), it is my opinion, every other Country that is dealing with BSE/TSE should boycott the USA and demand that the SSC reclassify the USA BSE GBR II risk assessment to BSE/TSE GBR III 'IMMEDIATELY'. for the SSC to _flounder_ any longer on this issue, should also be regarded with great suspicion as well. NOT to leave out the OIE and it's terribly flawed system of disease surveillance. the OIE should make a move on CWD in the USA, and make a risk assessment on this as a threat to human health. the OIE should also change the mathematical formula for testing of disease. this (in my opinion and others) is terribly flawed as well. to think that a sample survey of 400 or so cattle in a population of 100 million, to think this will find anything, especially after seeing how many TSE tests it took Italy and other Countries to find 1 case of BSE (1 million rapid TSE test in less than 2 years, to find 102 BSE cases), should be proof enough to make drastic changes of this system. the OIE criteria for BSE Country classification and it's interpretation is very problematic. a text that is suppose to give guidelines, but is not understandable, cannot be considered satisfactory. the OIE told me 2 years ago that they were concerned with CWD, but said any changes might take years. well, two years have come and gone, and no change in relations with CWD as a human health risk. if we wait for politics and science to finally make this connection, we very well may die before any decisions
or changes are made. this is not acceptable. we must take the politics and the industry out of any final decisions of the Scientific community. this has been the problem from day one with this environmental man made death sentence. some of you may think i am exaggerating, but you only have to see it once, you only have to watch a loved one die from this one time, and you will never forget, OR forgive...yes, i am still very angry... but the transmission studies DO NOT lie, only the politicians and the industry do... and they are still lying to this day...TSS


http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt

o.k., more opinion i said i would not have.
THIS all happened about the time GW et al and his bunch of scientific bozo's did away with the BSE GBR risk assessments and started there own commodities/futures science based approach to trading all strains of TSEs globally, this is called GWs infamous ''BSE MRR'' policy or the BSE Minimal Risk Region' or what i also call the 'BSE Most Risk Regions', because if everyone follows these stupid new guidelines, you will do just that, be spreading all strains of TSE globally, hence, these countries will be the ones most at risk, ESPECIALLY the ones importing from North America. The USA and Canada are in a Unique situation with TSEs, there are so many of them in different species. we have been rendering and feeding to animals for human and animal consumption for decades, thus the true number of phenotypes of TSE and the epidemiology of these TSEs are still unknown in relations to transmission to man and animal. WE have new atypical TSEs showing up now across the globe, so after some 3 decades of trying to eradicate, we are set back to the stone age of TSE pre-90s due to this BSE MRR policy. Thanks GW et al. you will go down in history in more ways than one.

sorry, i said i did not have an opinion in 2006, i slipped a bit there.


looking further into this ;


Oct. thru Dec. 2005 submissions

2002N-0273 Animal Proteins Prohibited in Ruminant Feed

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. As a company there are a number of precautions that we can
take by our strict specifications but many of the needed precautions require the force of federal
regulation, hence we appreciate the opportunity to submit comments to this very important
proposed rule.
After the identification of bovine spongiform encephalopathy (BSE) in indigenous North
American cattle, the U.S. Department of Agriculture (USDA) responded rapidly to implement
measures to protect public health in regard to food. Our company recognizes and supports the
importance of the current feed ban which went into effect in August 1997. However, given what
is known about the epidemiology and characteristically long incubation period of BSE, we urge
5655 Spalding Drive * Norcross, GA 30092
678-728-2000 * 800-842-9099 * Facsimile 678-728-2299
www.serologicais.com
Division of Dockets Management (HFA-305)
Page 2
9 December 2005
the FDA to act without further delay and implement additional measures which will reduce the
risk of BSE recycling in the US cattle herd.
We feel that for the FDA to provide a more comprehensive and protective feed ban, specified
risk materials (SRMs) and deadstock must be removed from all animal feed and that legal
exemptions which allow ruminant protein to be fed back to ruminants (with the exception of
milk) should be discontinued.
SRMs, as defined by the USDA, are tissues which, in a BSE infected animal, are known to either
harbor BSE infectivity or to be closely associated with infectivity. If SRMs are not removed,
they may introduce BSE infectivity and continue to provide a source of animal feed
contamination. Rendering will reduce infectivity but it will not totally eliminate it. This is
significant as research in the United Kingdom has shown that a calf may be infected with BSE
by the ingestion of as little as .OOl gram of untreated brain.
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. ” The base case scenario showed that the mean total number ofID.50~ (i.e.,
dosage sufficient to infect SO percent of exposed cattte) from healthy animals at slaughter
presented to the food/feed system was 1500, The mean total number of ID.50.s from adult cattle
Division of Dockets Management (HFA-305)
Page 3
9 December 2005
deadstockpresented to the feed system was 3 7,000.
deadstock).
This illustrates the risk of “40 cattle” (i.e.,
From the Harvard Risk Assessment, 2001, Appendix 3A Base Case and Harvard Risk
Assessment, 200 1 Executive Summary
Serologicals and companies like ours which supply components of drugs and biologicals have a
responsibility to the manufacturers of these products, the medical community and their patients
as well as regulatory agencies throughout the world to provide the safest products as possible.
Since there is no test for BSE in live cattle or for product, the regulatory agencies throughout the
world expect us to reduce or eliminate risk via suurcing criteria, These parameters may include
but not be limited to country of origin, herd of origin, age of the animal, etc. The United States
is no longer a country with negligible risk, hence individual animal criteria has become more
important. In fact other Centers of the FDA have stated that more attention should be given to
sourcing from herds likely to be a source of BSE free animals. The exemptions in the current
ban as well as in the newly proposed rule make this difficult if not impossible as there are still
legal avenues for ruminants to consume potentially contaminated ruminant protein. In addition,
the USDA still has not implemented a system of identification and traceability.
Serologicals urges agencies of the US government to work with academia and industry on
research in the following areas:
e Methods to inactivate TSEs agents which then may allow a product to be used and even
fed to animals without risk
l Alternative uses for animal byproducts which would maintain value
Serologicals will continue to work with the FDA and other government agencies to implement a
strong BSE risk control program, Serologicals would like to reiterate our opinion that for the
FDA to provide a more comprehensive and protective feed ban, specified risk materials (SRMs)
and deadstock must be removed from all animal feed and that legal exemptions which allow
ruminant protein to be fed back to ruminants (with the exception of milk) should be
discontinued. Thank you for the opportunity to submit these comments to the public record.
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

C 435 Government of Japan Vol #: 36


snip...


The Food safety risk assessment related to the import of beef and beef offal from the U.S.A. and Canada by the Food Safety Commission of Japan (FSC) was completed on December 8, 2005. REGARDING the feed ban, the following was noted as an ADDENDUM TO THE CONCLUSION ON THE RISK ASSESSMENT REPORT OF FSC:


"To prevent BSE exposure and amplification in U.S.A. and Canada, the use of SRM must be prohibited COMPLETELY. The ban must be applied not only to cattle feed but ALSO TO ALL OTHER ANIMAL FOOD/FEED that may cause cross-contamination."

snip...


http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000435-01-vol36.pdf

C 416 Valley Proteins, Inc. Vol #: 36

Dee I.5 cl5 ll:12a P- 1
0 0
P.O. Box 3588 Tele: (540) 877-2590
Winchester-, VA 22604-2586 Fax: (540) 877-3215
VALLEY PROTEINS, INC.
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 106 1
Rockville, MD
--A
December 15,2005_
Reference Docket Number 2002N-0273
To whom it may concern:
Valley Proteins and Carolina by Products have been in the rendering business for over
fifty years. One of the invaluable and under appreciated services we provide is the pick
up of dead animals; from producers as well as livestock sIaughtcr/process facilities. The
ability to handle these animals in a safe, economically and environmentally sound
manner is being put at risk due to provisions of the proposed rule 21 CFR part 589.
It seemed that FDA had always prided &elf in utilizing sound science in the decision
making process. FDA should be commended on taking a proactive stance in 1997 in
collaboration with members of industry to develop a sound rule regarding feeding of
ruminant materials to ruminants. This current proposed rule, which would amend the
existing rule, woulld lead one to believe that politics is winning out over science as there
is no sound scientific basis to make the proposals. For example:
l The feed baln put in place in 1997 is working. FDA’s own inspections indicate a
compliance rate of over 99%.
l USDA’s B!SE surveillance program that has tested nearly 600,000 high risk
animals has, detected only one positive animal. This particular animal was born 4
years prior ‘to the implementation of the existing feed ban. To our knowledge
there is no evidence that this animal ever consumed feed containing ruminant
proteins.
cm- 0a-n c +lb
Dee 15 05 11:12a
0
P-2
l It is our understanding that this animal in question did not test as a typical positive
using multiple testing methods.
l USDA’s BSE testing of 2 I ,2 16 healthy animals all tested negative.
l SRM’s are restricted from the human food chain therefore risk to human health is
negligible at best.
l Harvard Risk Analysis shows the potential for four additional BSE positive
animals over a 20 year span if 10 infected animals were introduced into the
market place. As this number is significantly higher than the prevailing rate in the
United States one would think the actual BSE risk is virtually non-existent. It is
our understanding that this Harvard Risk Analysis is being updated with current
surveillance data and we would hope that FDA takes this new risk analysis into
account.
In reality the existing program is working and will continue to work. There is no rational
reason to add these: new restrictions to the existing rule. Following are comments about
this proposed rule as well as consequences we foresee if this proposed rule were to go
into rfltxl;
l The European experience is referenced numerous times in the document. There is
no real comlparison between Europe and US given the prevalence of BSE in the
EU. l’here was also compensation to the rendering industry to keep processing
this material to eliminate any potential environmental issues.
l The implementation of this proposed rule will greatly reduce the supply of “high
risk” animals available for USDA’s BSE surveillance program.
.
l The implementation of this new rule could significantly impact the credibility of a
national animal ID system when said program is finally put into place.
l The cost to pick up dead animals would increase significantly if the current
proposed rule were to go into effect. We believe that our charges would increase
to approximately $150-$175 per animal to be able to economically pick up and
process these animals. It is our belief that the producer would not pay such a
charge and most of these animals would be disposed of in an environmentally
unsound manner.
l It is our belief that 65% of the dead ruminant animals we collect would not be of a
quality that would allow for the effective removal of the brain and spinal column.
l Valley ProtfeinsKarolina By Products collects over 67 million pounds of ruminant
dead stock per year. We believe that over 80% of this material would no longer be
processed due to fees we would need to charge due to the loss of protein sales
value. We believe this material would be buried on site or land filled. What will
the cnvirommental impact be?
Dee Y.5 05 11:12a
l There is over 17 million pounds of non ruminant dead stock that might not be
collected due to the expected poor economic returns for our routes if we
experience the expected loss of ruminant material on these routes.
l There would be a significant disposal issue for the small packers/abattoirs we
service. Spinal columns and brains from animals over 30 months of age would
have to be handled and transported separately. We believe the cost of this separate
service would force the supplier to dispose of this material in a landfill or other
less desirable disposal method. Our survey shows landfill fees of between $50 and
$135 per t0.n in our service area.
l If this proposed rule is implemented it is highly likely that 2 of our existing plants
would close. Close to 100 jobs could be at risk. A third plant would be
significantly impacted and could loose over 30 jobs.
. We feel that we would loose over 4 million dollars of product value from no
longer processing these animals.
l There is no scientific reason to remove the spinal column or brain from an animal
under 30 months of age.
9 We believe the improper disposal of these carcasses will lead to a broader spread
of animal disease and therefore be a much more significant: animal/human health
risk than BSE ever could be.
We believe there is no scientific reason to put the proposed rule into effect. There are
numerous firewalls in place that adequately protect our food and feed supply from BSE.
The risk of BSE is currently miniscule. We believe that the environmental and economic
impacts of the proposed rule would greatly exceed any potential risk reduction. We have
a system that is WORKING; let’s keep it.
P-3
Mike Reiser
Director of Marketing
Valley Proteins
540-877-3224

http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000416-vol36.pdf


http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000436-01-vol36.pdf


http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000246-01-vol24.pdf


http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000126-01-vol21.pdf


EVERYONE should remember valley protein don't you? i do ;-)


Friday, January 23, 1998 5:49 a.m. CT

Witness testifies some ill cattle sent to rendering plant

By CHIP CHANDLER
Globe-News Staff Writer

A senior vice president of Cactus Feeders Inc. testified Thursday that
cattle with central nervous system diseases were sent to a rendering plant.

Attorneys for talk-show host Oprah Winfrey tried to link those diseases
with mad cow disease during a sometimes heated cross-examination.

Mike Engler -- son of Paul Engler, the original plaintiff and owner of
Cactus Feeders Inc. -- agreed that more than 10 cows with some sort of
central nervous system disorder were sent to Hereford By-Products.

snip...

Encephalitis was indicated on the death certificates -- or ``dead
slips'' -- of three Cactus Feeders cows discussed in court. The slips
then were stamped, ``Picked up by your local used cattle dealer'' before
the carcasses were taken to the rendering plant.

snip...

@marillo Globe-News 2/18/98 1st -- Graphic pictures greet Winfrey Jury...

Pictures of sheep heads, euthanized pets and roadkill greeted jurors
this morning as they returned to the continuation of the cattlemen vs.
Oprah Winfrey lawsuit. The lawsuit continues today in U.S. District Mary
Lou robinson's court, but in a much diminished state. Robinson, after
hearing a day of arguments, granted the defendant's motions to dismiss
the case in part. The jury will not consider defamation and false
disparagement of food issues, Robinson ruled, but the trial will move
forward on the common-law business disparagement cause of action.
Defense lawyer Charles Babcock called Van Smith, a city Paper reporter
from Baltimore who had written an article on rendering plants in
September 1995. Smith and Babcock went through more than 50 pictures
taken as the reporter toured the Valley Proteins plant in Baltimore and
followed a rendering truck to the local animal shelter, a sausage plant
and a slaughterhouse. Babcock used the pictures to back up a statement
made by defendant Howard Lyman on "The Oprah Winfrey Show." Lyman's
statement was, "well, what it comes down to is about half the slaught of
...animals is not salable to humans. "They either have to pay to have to
put it into the dump, or they sell it for feed; they grind it up, turn
it into what looks like brown sugar, add it to all of the animals that
died unexpectedly, all of the roadkills, and the euthanized animals -
add it to them, grind it up and feed it back to other animals." Babcock
also said sheep were a part of this process, contrary to what he said
plaintiff Paul Engler earlier testified, that a voluntary ban on sheep
in the rendering plant was being followed. Joseph Coyne, plaintiff's
attorney, asked Smith what type of newspaper he wrote for. City Paper is
a free alternative weekly paper with a circulation of 91,000 that Coyne
said published "the bizarre and offbeat." "Really gross, wasn't it,"
Coyne asked Smith, referring to the pictures. Smith agreed and also said
Coyne was right when he said something had to be done with the pets and
animals that people do not take care of. "There are a lot of elements in
society that have to take responsibility for this problem," Smith. "The
rendering industry is quietly trying to take care of
it.".................

WITNESS TESTIFIES SOME ILL CATTLE SENT TO RENDERING PLANT... @marillo
Globe-News 1/23/98

A senior vice president of cactus feeders inc. testified Thursday that
cattle with central nervous system disease were sent to a rendering
plant. Attorneys for talk-show host Oprah Winfrey tried to link those
diseases with mad cow disease during a sometimes heated
cross-examination. Mike Engler -- son of Paul Engler, the original
plaintiff and owner of cactus feeders inc. -- AGREED that more than 10
cows with some sort of central nervous system disorder were sent to
Hereford By-Products. The younger Engler, who has a doctorate in
biochemistry from Johns Hopkins University, was the only witness jurors
heard Thursday in the Oprah Winfrey defamation trial. His testimony will
resume this morning. According to a U.S. Dept. of Agr. report from which
Winfrey attorney Charles Babcock quoted, ENCEPHALITIS caused by unknown
reasons could be a warning sign for BOVINE SPONGIFORM ENCEPHALOPATHY, OR
MADCOW DISEASE. ENCEPHALITIS was indicated on the death certificates--
or "DEAD SLIPS" -- of three cactus feeders cows discussed in court. The
slips then were stamped, "PICKED UP BY YOUR LOCAL USED CATTLE DEALER"
before the carcasses were taken to the RENDERING PLANT. Under later
questioning by plaintiff's attorney Joseph Coyne, Engler said he thought
symptoms of ENCEPHOMYOLITIS, which include the cow keeping its head
locked in an upright position, were "inconsistent with what was observed
in England" with BSE-infected Cattle.

During direct testimony on Thursday morning, Engler outlined the
standard procedures for feeding cattle in feedlots. To do so, he mixed
in a large, clear plastic bowl the ingredients that would make up the 20
pounds of feed a feed-yard animal eats per day. The recipe contained 78
percent steamed, flaked whole corn; 10 percent roughage; 3 percent
liquid fat; 2 percent molasses; and 1 percent vitamins and
PHARMACEUTICALS, Engler said. The remainder would be a supplement, an
ingredient bought from feed manufactures to provide protein. This
portion would be made primarily of cottonseed or soybean meal, BUT COULD
CONTAIN MEAT AND BONE MEAL. Before this summer, that meal could have
contained rendered cattle parts, which is believed to have contributed
to the spread of MADCOW disease in England, Engler said. The government
issued a mandatory ban on such feed on Aug. 4. Later, Babcock and Engler
fought over Lyman's statement that "COWS ARE EATING COWS." Engler would
not concede, as Babcock wanted, that rendered cows can still be
considered cows when part of bone and meat meal. Corn is processed into
fructose, which is then used in soft drinks, Engler said. "When people
drink Cokes, they don't say they're drinking corn," he said, arguing
that a similar process happens with rendered cows. During the day's
testimony, Engler also said statements by Lyman were inflammatory and
false. He said the statement "100,000 cattle are fine at night, dead in
the morning," made by Lyman, is untrue. "It simple doesn't happen,"
Engler said, adding that most cattle that die are the victims of lengthy
illnesses with symptoms that are tracked. When questioned by Lyman's
attorney, Barry Peterson, Engler said he did not know whether cattle
with BSE might have been imported from England or other countries before
bans on those countries cattle were enacted. Peterson focused on the
only known case of BSE in Canada. He said cattle from that herd were
brought to America. Though most were found and destroyed, some could NOT
be located, he said. "You can't tell me today that some of those cattle
were not turned over to a renderer:" Peterson asked. "Nor can I say they
were," Engler answered///


http://www.amarillonet.com/

C 414 Northwest Meat Processors Association Vol #: 36


working for the meet industry of the northwest
Northwest Meat
Processors Associatm 3
OFFICERS
Pmsidsnt
Jerry Haun
llaun’s Meat & Sausage
Rt 1 Box 24OA
Vice Ptwident
Steve Quanz
Hemplerk
1401 F St
Bellmgham, WA 98225
360-734-5330 December 13,2005
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 106 1
Rockville, MD 20852
RE: Docket No. 2002N-0273
Substances Prohibited From Use in Animal Food or Feed
The Northwest Meat Proces;sors Association would like to submit the following comments
on the amendments to the Agency’s regulation, “Substances Prohibited From Use in
Animal Food or Feed.”
The Association is a regional group with members involved in meat and poultry
processing, slaughterers, caterers, food service companies, wholesalers, retailers, and
suppliers.
We have concerns over the amendments to the “Substances Prohibited From Use in
Animsl Food or Feed” regulations because of the impact the changes will have on our
membership. Since our membership consists of mainly small and very small businesses,
these proposed changes will severely affect them. Increased costs passed on fi-om the
rendering industry, as well als elimination of certain by-product materials from pick-up will
have the most economic impact on small and very small processors.
The disposal of the Specified Risk Materials (SRMs) will be the biggest challenge of the
proposed amendments. Currently, most meat slaughterers and processors rely on renderers
to dispose of the inedible by-products industry collects
and processes over 47 billio@@i& these industries and
transforms the inedible prodiucts into useful and valuable feed and industrial materials.
Rendering adds millions of ldollars in value to livestock production through the
manufacture of protein materials while removing the need to dispose of meat industry byproducts
in landfills or by other methods that may impact public health and the
environment.
Additional regulation of livestock feed ingredients through the proposed amendments will
reduce the demand for rendered material, which will increase by-product disposal costs.
Higher livestock production costs, lower value for slaughtered animals, reduced
profitability for renderers, increased costs for processors, and more expensive meat
products for consumers are all very likely to occur. A reduction in the value of byproducts
directly reduces the amount packers are able to pay for livestock, creating a
vicious cycle of events.
more
Secretary-Treasurer
Dayle Robnetl
Diamond S Meat Co
7400 Kmgs Way
Klamath Falls, OR 97603
541-804-8767
Past Pf66ident
Brian Dolby
Gene’s Meat Market
PO Box66
Mehama, OR 97384
503-859-2252
DIRECTORS
Doug Chlechl
Doug’s &al&y Meats
253-052-9744
Pat Calrus
Del Fox Custom Meats
360-629-3723
Jim Hanson
Carlton Farms
503-852-7166
Gary Mallett
Eastern OR Moble Slaughter
541-567-2011
Dawd Mayo
Oversea Casing Co
206-682-6845
Steven McLaren
Market Supply
503-239-4990
Ben Moore
Redmond Lockers
541-540-5575
EX-OFFICIO
Jan Busboom
Washqton State Unlvenlty
509-335-2880
Bob Dickson
Oregon State Universtly
541-737-3414
Ron Richard
Unwerscty of Idaho
208-885-6727
EXECUTIVE DIRECTOR
Dennis Hay6
emall haysmgmt@pipelmne corn
2380 N.W. Roosevelt, Portland, OR 97210 l 503-226-2756 . FAX 503-224-0947
2. Comments on Docket No. 2002N-0273
If rendering becomes too expensive for meat slaughterers and processors to use, they are left with few
alternatives. Landfills will not be able to handle the increased amount of material, and there are many
costs associated with using I andfills for disposal. Some landfills do not accept these types of materials
and hauling such materials may require special vehicles or permits. Composting or burying of byproducts
takes a considerable amount of land and time, as well as additional labor. It is only a viable
option for those establishme:nts in rural areas with available land and the equipment to properly compost
or bury by-product material. Burying creates the largest risks for human health and the environment
because of the potential for ground and surface water pollution if proper techniques are not followed.
Incineration requires a signilicant capital expense and constant fuel supply, as well as permits to operate
legally. It is probably not economically feasible for a small processor to purchase an incinerator and have
enough volume to make it run efficiently. Also, instead of creating a return for by-products by sending
them to be rendered, incineration, landfilling, and burying offer no value for those products. There are
definite environmental concerns with all of these options, as well as possible risks to public health. The
meat industry is often the folcus of public scrutiny and must be very conscious of the view of consumers,
especially where both human health and the environment are concerned.
Another concern the Association has is for establishments that are considered custom-exempt. The
proposed rules indicate that “‘the entire carcass of cattle not inspected and passed for human consumption
if the brain and spinal cord have not been removed” would be banned from livestock feed. This means
that custom-exempt facilities would need to remove the brain and spinal cord from the remaining offal
prior to it being acceptable I%r rendering, otherwise none of the animal would be allowed to be used.
Again, this increases production and labor costs for small processors.
We appreciate the chance to comment on the proposed amendments to the “Substances Prohibited From
Use in Animal Food or Feed.” We hope that the FDA will take our concerns to heart and evaluate the
proposed rules accordingly, The associated costs and economic impact for small and very small meat
processors will be great and environmental concerns with the proposed amendments are large. Until more
cost effective alternatives to rendering by-products from slaughter are available, these amendments will
cause undue harm to processors. The United States Department of Agriculture’s BSE testing program
should clearly indicate that ESE is not a problem in this country and prove that the current safeguards are
not in need of modification.
Dennis Hays
Executive Director
cc: Jerry Haun, President


http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000414-01-vol36.pdf


C 421 Baker Commodities, Inc. Vol #: 36

@
/
0763 5 DEC 15 P1:59
December 13,2005
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, Maryland 20852
Re: Docket No. 2002N-0273, Substances Prohibited From Use in Animal Food or Feed
To Whom It May Concern:
I am the President of Baker Commodities, Inc., one of the major rendering companies in
the United States. We are extremely concerned about the FDA’s proposed changes to
the 1997 ruminant to ruminant feed ban. We believe that this change is not necessary
as the current feed ban is working and the proposed change would be very costly to
cattlemen, dairymen, renderers and consumers with little or no reduction in the risk of
bovine spongiform encephalopathy (BSE) or mad cow disease.
On October 5, 2005, FDA published an advance notice of proposed rule making
(ANPR) in the Federal Register. The ANPR proposes changes to the existing feed ban
that was enacted in 1997, which prohibits the feeding of ruminant-derived proteins back
to ruminants. FDA is under constant pressure by so-called consumer groups, animal
rights advocates and other special interest groups to make these changes under the
guise of reducing the threat of BSE within the United States. Although the enhanced
surveillance program instituted by USDA has demonstrated that the risk of BSE in our
nation’s herd is virtually nonexistent, these groups have chosen to focus on the 2003
BSE case in Washington State involving a cow of Canadian origin, and the 2005 BSE
case in Texas, an anilmal that was approximately twelve years old.
USDA has completecl testing on over 555,000 samples submitted for BSE testing. Of
these samples, 535,000 were taken from animals that USDA and FDA believe are “at
the highest risk of testing positive for BSE.” These so-called “high risk animals” are
animals that are over 30 months of age, that have died from causes other than
slaughter, as well as non-ambulatory and disabled cattle. In other words, these were
animals that either died on the farm or were downers. In addition, Senator Tom Harkin
(D-Iowa) suggested to the U.S. Dept. of Agriculture that tests on healthy cattle be done
because some clinically “normal” cattle over 30 months of age had tested positive for
c WI BAKER COMMODITIES INC. @udifg aud pllide..&ddde
4020 Bandini Boulevard, Los Angeles, CA 90023-4674 (323) 268-2801 FAX (323) 268-5166
December 13,2005
FDA Proposal to Amend Feed Rule
Page 2 of 5
BSE in other countries. These tests have been completed. The original goal was
20,000, but the department exceeded that goal, by stopping at 21,216.
Having tested well over one half million head of cattle from what USDA considers to be
the “highest risk population,” and having found one animal that has tested positive
under very questionable circumstances (the Texas case), provides more than enough
scientific data to back up the assertion that the livestock and rendering industries have
made for years. Our beef is the safest in the world, and BSE poses no risk to human or
animal health in this country.
Nevertheless, the Food and Drug Administration (FDA) has chosen to ignore the
scientific data that the enhanced surveillance program has afforded us, and chosen to
propose further changes to the feed rule that will place a hardship on both industry and
the producer. FDA maintains that there is virtually no economic or environmental
impact as a result of the proposed rule. This position by FDA is blatantly wrong, and
serves only to enable the agency to impose the recommended changes without
requiring them to conduct an economic or environmental assessment.
There are several items in the proposed rule that are bothersome. Namely, the
requirement in the proposed rule stating that packers remove the brain and spinal cord
from all cattle over 30 months of age and the prohibition from using specified risk
materials (SRM) in all animal feed. This will require the packer to install separate
handling equipment on the kill floor, for this material, so that it can be disposed of
properly, where as now, it is commingled with other inedible by-products. If the packer
renders his own inedible by products, he will have to add additional equipment to
process this material, or dispose it in some other manner. If a render is picking up the
packer’s inedible by-product, the packer will have to provide a system where the SRM’s
can be picked up separately, in designated vehicles by the render.
A requirement in the proposed rule mandating the removal of the brain and spinal cord
from cattle of any age not inspected and passed for human consumption poses
additional problems and costs to renderers. This means that all animals that die, mainly
at feed lots and farms, regardless of age, and non-ambulatory disabled cattle, will have
to have their brains alnd spinal cords removed before other parts of the animal can be
used for animal feeds.
Removing the brain and spinal cord from dead cattle picked up at the farm or feedlot is
not impossible, but it is not an easy task. It is a very labor-intensive process that is
further complicated by seasonal changes that greatly affect the condition of the animal
and the ability to successfully remove these materials. Our central California dead
stock plant processes over 5,000 of such animals each week.
2
December 13,2005
FDA Proposal to Amend Feed Rule
Page 3 of 5
During the winter months, with colder temperatures and wind chill factors, the spinal
cord becomes frozen in the vertebral column making it impossible to remove the spinal
cord without either spllitting the carcass or cutting off the ribcage and disposing of the
entire vertebral column. Likewise the brain cavity of the animal freezes requiring
disposal of the entire head. In calves, the entire carcass would require disposal as
SRM’s considering the amount of labor required to separate these materials in
comparison to the value of finished product derived from the remaining portion of the
carcass.
During the summer months, rapid decomposition of the animal may make removal of
SRM’s in some animals impossible, requiring the entire carcass to be disposed of. In
concentrated dairy areas it is not uncommon for renderers to procure thousands of
calves per week that would now have a negative economic value to the renderer at the
present pickup fee. Of the 5,000 weekly animals processed at our central California
dead stock plant , approximately 3,000 are calves.
Renders will be required to either construct separate facilities for processing SRM’s or
take them to a landfill. Constructing additional facilities will be very difficult due to
zoning restrictions, grandfathering and plant cost constraints. There will most likely be
insufficient SRM’s generated by any one render to justify the cost of such a facility.
Multiple renders may decide to construct regional facilities to handle SRM material.
This raises anti-trust and other concerns.
The least cost method for disposing of SRM’s would be land filling. Incineration,
cornposting and chemical digestion have a significantly higher cost than rendering,
which may not be available due to the limited quantity of such material.
Why is the FDA worried about animals less than 30 months of age? For human
consumption, packers only have to remove the brain and spinal cord from animals over
30 months old. Why should there be a greater standard for animals being used for feed
purposes? There is no scientific basis for removing the brain and spinal cord from a
calf.
Landfill disposal is generally the least cost option for SRM disposal. This creates
several additional problems as a result. First, not all landfills are permitted by EPA to
accept raw animal malterials. Second, landfills that are permitted may elect to classify
this material as special or hazardous waste and charge significantly higher fees for its
disposal. Third, but by no means the least significant problem, is that scavengers such
as coyotes, dogs, rats and other animals will enter the landfill and scatter raw animal
materials throughout the surrounding area. This problem in and of itself creates a far
3
December 13,2005
FDA Proposal to Amend Feed Rule
Page 4 of 5
more significant risk t:o human and animal health than the threat of BSE under the
current feed rule. We believe that an environmental impact study should be required
before greatly increasing the amount of raw animal materials being disposed of using
non-rendering methodologies.
Transportation of these materials to the landfill will be another significant cost to the
renderer and the packer alike. Under the proposed rule, separate dedicated containers
must be used to collect these materials once they are separated from the carcass. This
would include separate dedicated containers within the packing or rendering plant
facility, as well as separate dedicated trucks or trailers for transporting these materials
to the landfill.
FDA has cited three rnain reasons further regulations are needed. These are: Cross
contamination during feed manufacturing or transport, unintentional misfeeding on the
farm and the concern that poultry litter that is currently allowed in cattle feed may
contain spilled poultry feed and would provide a source of contamination in ruminant
feed. Comments regarding this concern were submitted to FDA in 2004.
FDA has stated on one hand that it acknowledges that livestock production in the United
States is greatly different than livestock production in other countries, particularly in the
United Kingdom, where multi-specie farms are commonplace. On the other hand, FDA
continually refers to the BSE situation in the UK, where livestock production and
rendering practices are greatly different.
And why did the USDA have EU scientists recommend steps that our government
should take to prevent the establishment of BSE in the U.S. and prevent exporting
contaminated feed, if we did have BSE? It seems that the EU should have paid more
attention to their own exports of contaminated feed, at discount prices, all over the
world, which resulted in Japan and other nations, having BSE .
The Harvard Study commissioned by USDA states that the existing firewall provided by
the current feed rule makes the United States “extremely robust against the
establishment of BSE.” The Harvard Study also points out that if introduction of BSE
had occurred via importation of live animals from the United Kingdom before 1988, that
the current feed rule hlas minimized exposure, and began to eliminate the disease from
the cattle population, even assuming less than complete compliance with the feed ban.
If the proposed rule is made final by FDA there may be significant economic,
environmental and human and animal health impacts. The costs associated with the
proposed rule will certainly lower the market value of animals over 30 months of age
sold to packers. Renderers will be forced to increase their fees for the removal of dead
4
December 13,2005
FDA Proposal to Amend Feed Rule
Page 5 of 5
or disabled cattle to offset the labor and disposal costs associated with the rule.
Smaller or less conscilentious producers may elect to improperly dispose of dead cattle
to avoid pickup fees and create further environmental and human and animal health
issues, in addition to those imposed by placing raw animal materials in a landfill.
Consumer groups, animal rights activists and special interest groups will be very vocal
in their support of further regulation. It is up to the FDA to realize that we DO have the
safest and best beef and milk in the world, and that no further action is necessary.
I would like to summarize this letter by saying “ENOUGH IS ENOUGH” and it is not too
late to tell Brussels, OIE, and the EU to “KISS OUR ASS”.
Very Truly Yours,
BAKER COMMODITIES INC.
C/bresident

http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000421-01-vol36.pdf

C 426 Fayetteville animal Clinic, P.C. Vol #: 36

HOLLY ANDREWS, D.V.M. W. H. KIDD, D.V.M.
MARGIE CARTER, D.V.M. STACY SMITH, D.V.M.
MARY CHORNEY, D.V.M. NAT WALKER, D.V.M.
FAYETTEVILLE ANIlMAL CLINIC, I-X’.
FAYETTEVILLE, TENNESSEE 37334
TELEPHONE (93 1) 433- 1202
t)?i?! 5 DECl5 A9:49
Dear Sir/Madam,
Comment on Docket No. 2002N-0273 Proposed Rule To amend BSE Feed Ban
Our veterinary practice is located in a rural area of southern middle Tennessee. This
area has a large agricultural livestock business. The county we are located in (Lincoln
County) is number one in the state of Tennessee in terms of beef cattle numbers with
approximately 70,000 head. Currently our dead animals are removed by a rendering
company (Griffin Industries). The proposed rule to amend the BSE feed ban, if enacted,
would effectively stop dead animal removal by the rendering company in our county as
well as surrounding counties. It would be impossible to economically and practically
remove the brain and spinal cord from all the dead cattle so the companies would stop
picking them up.
The only practical alternative would be burial. Non compliance with proper burial, or
no burial at all, would be a big problem. On numerous farms in our county soil is not
deep enough to bury an animal correctly. Our county is located in a geographic area of
rolling hills with numerous limestone rock outcroppings and caves with water running
into the caves. There is no county wide public water system that serves everyone. A
large percentage of our population still relies on wells and springs for their drinking
water. Not having a rsendering service pick up dead animals would lead to ground and
surface water contamination, a danger to livestock and human health, and causing odor
and aesthetic problems throughout the county. It would also result in increased cost to
the farmers and loss of otherwise useable cattle by-products.
In addition, the current ruminant to ruminant feed ban prevents possible spread of
BSE in cattle. Other animals that might consume cattle by-products are not in the human
food chain and would not pose a risk to human health.
The USDA surveillance program has demonstrated that the United States does not
have a problem with BSE. The miniscule risk of BSE does not warrant all the increased
risk to human and environmental health that the above rule would create.
We would like to respectfully request that the above rule be withdrawn from
consideration.
Sincerely,
Fayetteville Animal Clinic
Holly Andrews, D.V.M.
Mary Chorney, D.V.M.
Margaret Carter, D.V.M.
William H. Kidd, D.V.
Stacy Smith, D.V.M.
Nat Walker, D.V.M.


http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000426-01-vol36.pdf

C 413 Farmers Union Industries, LLC Vol #: 36


0
IJJ 002,‘00~.
0 Phone: 507-537-2935
Fax: 507-637-5499
Farmers Union Industries, LLC I.
590 west Park Roh l :‘A B&3,9
. I.
l h&Wood Falls, Minnesota 56283-0379
Dee 14,2005
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, ‘Room 1061
Rochiie, Maryland 20852.
Re: Dtxket Na 2002~'0273, .krbstunces Rohibited From use in Artimal Food
OrFeed
To Whom It May Concern:
This letter is in reference to FDA's Docket No. 2002N-0273, the agency’s proposed rule
and the invitation to comment on substances prohibited from use in animal food or teed.
Central Bi-Products; is the largest rendering company in the State of Minnesota with
plants located in Redwood Falls and Long Prairie. We provide rendering suvice to three
cow slaughtering plants, killing animals over 30 months of age, over a thousand locker
plants that are not IJSDA inspected, and farm pick-up of mortalities. The FDA proposed
rule 2 1 CFR Part 589 will create an extreme hardship for these customers and Central Bi-
Products.
COW Slaughter plants will have 3,500,OOO pounds of brains and spinal cords that we will
not allow into our rendering plants based upon current understanding of the proposed rule
and facility compliance. This m&al will most likely go to land fills.
Locker plants in oulr service area will have over 20 million pounds of material that could
potentialIy be land ffilled.
On Gum mortalities create the largest problem, Central B&Products provides removal
service to Minnesota, Eastern South Dakota and SE North Dakota. If the rule becomes
law, Central B&Products will be forced to discontinue dead stock pick-up of all bovine
animals leaving the farmers and ranchers in excess of 35,OOO,OOO pound of animals that
will be disposed of by land fills, burial, dumping into creeks and rivers, or what ever
means can be used to make these animals disappear. In addition this loss of material and
revenue to contract haulers would most likely eliminate economic pick-up for porcine
mortalities as well. Our analysis shows that the only route that would continue to exist
would be those seAng commercial f&lots. This would result in the elimination of 24
contract hauler positions and present another financial burden to the family farm. Central
Bi-Products would ‘become an independent packer/renderer with this law.
oak ox!! CY\3
12/14/2005 14:47 FAX
The states sewed by our mmpany would lose the important disease control and
monitoring service ithat we have provided to state and federal agencies over the past
twenty-six years. We have served USDA and state veterinary seryices with disease
reporting and control, including the service our cxxnpany provided BS part of the BSE
suweilhnce program.
The USDA has tested 530,000 animals for BSE with only one positive case. We do not
have a health concern Corn BSB. Firewalls are in place to assure that ruminam byproducts
are not feed back to ruminants. The FDA rule is not needed to protect our beef
supply, moreover it will create a large economic loss to the industry and create a situation
with dead rotting araimals and animal parts be disposed of in unsafe ways. We could
potentially be neat@ a breeding ground for many other diseases that arc more dc&ly
than BSE. Furthermore, if we do have a positive BSE animal that is burled or allowed to
rot and be scavenged be wild animals do we not provide a path &r unwanted spread of
the priori. What will fiture generations think of the FDA if we allow this to happen.
We disagree with tbe conclusion that i%rther acrion pvsed in the rule is necessary,
urge the FDA to seriously consider comments from the National Renderers Association
(NRA)andthe2005R d en ering Industry Study by In&ma Economics, and urge the
agency to do indeptb economic and environmental impact studies, based on current and
representative data, before formalizing the proposed rule.
We continue to support scientifically based animal feeding regulations to restrict the use
of certain animal proteins derived tirn mammalian tissues used in ruminant feeds. We
agree that animal feed regulations need to be reviewed from time-to-time if new risks are
identified or new, relevant scim is brought to light. However, we agree with the NRA
analysis of the facts and believe FDA’s preliminary conclusion to remove cattle brains
and spinal cord and rendered dead animals from all animal feed is not warranted and this
action aimed at removing a very minute risk from BSE will increase risks from other
diseases, cause environmental degradation, and cost much more than can be justified.
The 1997 feed rule iis working and compliance is extremely high. The USDA enhanced
surveillance testing program found only one indigenous cow tested positive for BSE out
of more than 534,879 surveillance samples Corn high risk groups over the past 15 months
showing the incidence of BSE in the U.S. to be near zero. The National Cattleman’s
Beef Association esrtimates an infection rate in the U.S. of one in more than 18 million
caWcle over 30 months of ag*for all practical purposes it is statistically zero.
Applying the wrne rules as recommended in Europe is nonsense. The incidence in the
U.S. is at least 500 fold lower than in the EU. The U.S. instituted preventive masures
long before Burope, and the early action assured the infection was never established here.
It is also worth noting that the rendering industry in Europe is heavily subsidized so that
prohibited materials are picked up and processed avoiding a massive disposal problem.
We agree witb NRA,‘s statement tbt the feasibility of removing brains and spinal cords
from dead stmk is very low except under the best conditions of weather, climate, distance
betareen production and rendering locations, age, size, and condition of cattle, works
12/14/2005 14:4R FAX
skill, and equipment and technology, Renderers will be forced to charge higher
collection f&es to cover the increaSed costs of material disposal, professing, and lost
product revenues olr end the practice of collecting dead urttle altogether. The magnitude
of the disposal prohlem the proposed rule would cause is much larger than FDA
estimates.
FDA describes the primary benefit of the proposed rule as “elimination of the vast
majority of the risk of spreading BSE to other cattle fiom intentional or unintentional use
of non-ruminant feed for ruminants or cross-contamination of ruminant feed with nonruminant
feed or ingredients intend4 fbr non-ruminant f&.” The risks eliminated by
the proposal are likely much smaller than the fiture risks of burying carcasses and
disease agents on the fivm at best, and more inappropriate methods at worse.
If the FDA requires dedicated flxilities, equipment, storage, and transportation equipment
to handle prohibited cattle materials, it may not be economically feasible for rendenxs to
continue prooessing such material. It would be more likely for this material to be
deposited in landfills, resulting in increasexl environmental exposure because of the high
biological load of this material in its unpr~sed state.
In summary, we believe this action aimed at removing a very minute risk corn BSE will
increase risks &om other diseases, cause environmental degradation, and cost much more
than can be justified-fbr renderers, producers, procus~ n, and society. We urge the
FDA to take no fbrther action to add restrictions to the 1997 feed rule.
Resm y submitted by:
&-
Charles Neece
Director: Research and Development
Farmers Union Industries
Central Bi-Products, div.


http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000413-01-vol36.pdf

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

Dockets Entered On December 22, 2005


2002N-0273 Animal Proteins Prohibited in Ruminant Feed
C 454 United States Animal Health Association (USAHA) Vol #: 39
C 455 Australian Government Vol #: 39
C 456 R. Moore et al. Vol #: 39
C 457 Kentucky Farm Bureau Federation Vol #: 39
C 458 Baker Commodities, Inc. Vol #: 39
C 459 Farmers Union Industries, LLC Vol #: 39
C 460 B. Smith Vol #: 39
C 461 National Renderers Association, Inc. (NRA) Vol #: 39
EC 197 PARAMORE MEAT PROCESSING Vol #: 34
EC 198 Center for Food Safety Vol #: 34
EC 199 Pennsylvania Department of Agriculture Vol #: 34
EC 200 Tennessee Department of Agriculture, animal health Vol #: 34
EC 201 APC, Inc. Vol #: 34
EC 202 N. Amer. Spray Dried Blood Vol #: 34
EC 203 McDonald's Restaurants Corporation Vol #: 34
EC 204 Mrs. Bonnie Warner Vol #: 34
EC 205 McDonald's Restaurants Corp Vol #: 34
EC 206 Dr. Farris Beasley Vol #: 34
EC 207 Kentucky Department of Agriculture Vol #: 34
EC 208 American Farm Bureau Federation Vol #: 34
EC 209 VA Department of Environmental Quality Vol #: 34
EC 210 The National Assn of State Depts of Agriculture Vol #: 34
EC 211 Food Vol #: 34
EC 212 Mrs. melissa cave Vol #: 34
EC 213 Tennessee Farm Bureau Federation Vol #: 34
EC 214 Marshall County Farm Bureau Vol #: 34
EC 215 Giles County Farm Bureau Vol #: 34
EC 216 South Dakota Animal Industry Board Vol #: 34
EC 217 Texas and Southwestern Cattle Raisers Association Vol #: 34
EC 218 Dr. John Eckman Vol #: 34
EC 219 Clemson University Vol #: 34
EC 220 American Meat Institute Vol #: 34
EC 221 Carolina By Products Vol #: 34
EMC 124 J. Jones Vol #: 14
EMC 125 L. Cunningham Vol #: 14
EMC 126 National Grain and Feed Association (NGFA) Vol #: 14

http://www.fda.gov/ohrms/dockets/dailys/05/Dec05/122205/122205.htm

2002N-0273 Animal Proteins Prohibited in Ruminant Feed
C 462 Darling International, Inc. (Darling) Vol #: 39
C 463 World Renderers Organization Vol #: 39
C 464 Food Animal Concerns Trust (FACT) Vol #: 39
C 465 Georgia Department of Agriculture Vol #: 39
C 466 National Grain and Feed Association (NGFA) Vol #: 39
C 467 Georgia Department of Agriculture Vol #: 39
C 468 M. Wise Vol #: 39
C 469 R. Kidd Vol #: 39
C 470 J. Kidd Vol #: 39
C 471 Eligible Vol #: 40
C 472 University of California Vol #: 40
C 473 Honorable Randy Neugebauer Vol #: 40
C 474 R. Martin Vol #: 40
C 475 A. Allebach Vol #: 40
C 476 Georgia Department of Agriculture Vol #: 40
C 477 Northwest Meat Processors Association Vol #: 40
C 478 Maryland Department of Agriculture Vol #: 40
C 479 B. Harris Vol #: 40
C 480 Association of American Feed Control Officials, Inc. (AAFCO) Vol #: 40
C 481 R. Biven et al. Vol #: 40
C 482 American Feed Industry Association (AFIA) Vol #: 40
C 483 Wisconsin Department of Agriculture, Trade and Consumer Protection (DATCP) Vol #: 40
C 484 County Mayor of Coffee County Vol #: 40
C 485 California Grain and Feed Association (CGFA) Vol #: 40
C 486 Consumers Union Vol #: 40
C 487 Washington State Department of Agriculture (WSDA) Vol #: 40
C 488 Griffin Industries, Inc. Vol #: 40
C 489 National Meat Association (NMA) Vol #: 40
C 490 Paul W. Brown, MD et al. Vol #: 40
C 491 C. Bremmer Vol #: 40
C 492 Food Safety and Inspection Service (FSIS) Vol #: 40
C 493 A. Bobo Vol #: 40
C 494 Kentucky Dairy Development Council (KDDC) Vol #: 40
C 495 Eligible Vol #: 40
C 496 J. Chorest Vol #: 40
C 497 Baker Commodities, Inc. Vol #: 40
C 498 Consolidated Blenders, Inc. (CBI) Vol #: 40
C 499 M. Fisher Vol #: 40
C 500 National Cattlemen's Beef Association (NCBA) Vol #: 40
C 501 Center for Food Safety (CFS) Vol #: 40
C 502 J. Longo Vol #: 40
LET 1 Honorable John E. Peterson Vol #: 40
LET 2 Honorable John E. Peterson Vol #: 40
LET 3 Honorable Jim Bunning Vol #: 40
SUP 1 Article on Spongiform Diseases Vol #: 40

http://www.fda.gov/ohrms/dockets/dailys/05/Dec05/122305/122305.htm

http://www.fda.gov/ohrms/dockets/dailys/05/Dec05/122005/122005.htm#02N0273

2002N-0273 Animal Proteins Prohibited in Ruminant Feed EC 178 Ms. Erin Riddle Vol #: 34 EC 179 Christian County KY Fiscal Court Vol #: 34 EC 180 Mrs. JOANNE BURKE Vol #: 34 EC 181 Ms. Kelli Burke Vol #: 34 EC 182 Miss. Julianne Pach Vol #: 34 EC 183 Ms. Tammy Maes Vol #: 34 EC 184 Mr. Alan Albright Vol #: 34 EC 185 Ms. Stacy Rullman Vol #: 34 EC 186 Valley Proteins, Inc Vol #: 34 EC 187 Valley Proteins, Inc Vol #: 34 EC 188 Christian County, KY Fiscal Court Vol #: 34 EC 189 Anamax Vol #: 34 EC 190 Mr. Pablo Lau Jr. Vol #: 34 EC 191 Dairy Farmers of America, Inc. Vol #: 34 EC 192 Strickland Enterprises Vol #: 34 EC 193 Mrs. Mary Max Vol #: 34 EC 194 Mr. RANDY JONES Vol #: 34 EC 195 Mr. Daniel Cooper Vol #: 34 EC 196 Dr. Loretta Pesteanu Vol #: 34


http://www.fda.gov/ohrms/dockets/dailys/05/Dec05/121905/121905.htm#02N0273


http://www.fda.gov/ohrms/dockets/dailys/05/Dec05/122705/122705.htm

http://www.fda.gov/ohrms/dockets/dailys/05/Dec05/122805/122805.htm


http://www.fda.gov/ohrms/dockets/dailys/05/Dec05/122905/122905.htm


2002N-0273 Animal Proteins Prohibited in Ruminant Feed
C 384 E. Herndon, Sr. Vol #: 35
C 385 M. Martin Vol #: 35
C 386 M. Cramer Vol #: 35
C 387 M. Miller Vol #: 35
C 388 H and J Howbaher Vol #: 35
C 389 P. Olsen Vol #: 35
C 390 J. Manion Vol #: 35
C 391 R. Travis Vol #: 35
C 392 C. Cheeks Vol #: 35
C 393 R. Gilbo Vol #: 35
C 394 G. Russell Vol #: 35
C 395 J. Schnobrich Vol #: 35
C 396 D. Teeter Vol #: 35
C 397 J. Shand Vol #: 35
C 398 M. Yohe Vol #: 35
C 399 S. Twitchell Vol #: 35
C 400 L. Taylor Vol #: 35
C 401 T. Amato Vol #: 35
C 402 C. Schultz Vol #: 35
C 403 Gibson County Courthouse Vol #: 35
C 404 D. Diaz Vol #: 35
C 405 E. Burkholder Vol #: 35
C 406 J. Harker Vol #: 36
C 407 R. Williams Vol #: 36
C 408 S. Reneau Vol #: 36
C 409 Giles Couny, Tennessee Vol #: 36
C 410 J. Tyler Vol #: 36
C 411 M. Lukasiewicz Vol #: 36
C 412 Honorable Randy Neugebauer Vol #: 36
EC 165 New Zealand Embassy Washington DC Vol #: 34
EC 166 Ms. Diane Weinstein Vol #: 34
EC 167 Mr. Dwight Ward Vol #: 34
EC 168 Mrs. Teresa Russo Vol #: 34
EC 169 Ms. Jennifer Otway Vol #: 34
EC 170 Mrs. Ursula Pelka Vol #: 34
EC 171 Miss. Erin Maupin Vol #: 34
EC 172 Mr. Marvin Huyser Vol #: 34
EC 173 Williamson Co. Cattlemen Vol #: 34
EC 174 Ms. Kelly Flood Vol #: 34
EC 175 Mrs. James Denison Vol #: 34
EC 176 Farm Sanctuary Vol #: 34
EC 177 Ms. Jo Tyler Vol #: 34

http://www.fda.gov/ohrms/dockets/dailys/05/Dec05/121405/121405.htm#02N0273


http://www.fda.gov/ohrms/dockets/dailys/05/Dec05/121305/121305.htm#02N0273


ROBERT LA 70455
DECEMBER I., 2005
Division of Dockets Management @IFA-306)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
RE: FDA Docket No. 2002N-0273
RIN 09 1 O-AF46
To Whom It May Concern:
Due to the fact the BSE issue is winding down and the USDA’s Surveillance Program clearly
shows we do not have a BSE risk to the United States cattle population we appeal to you to
reconsider the proposed ruling above referenced. The current ~M~ina~t to ruminant feed ban
created in 1997 has been in force longer than most living animals and within two years will have
survived all living cattle. There is therefore, no need for additional feed restrictions based on
current compliance.
’ We cannot understand why the FDA would impose unwarranted additional hardship and
expenses on the meat packing industry, not to mention the hazard created to human health that
might be caused by disposal, other than through the services of the rendering facilities. Such
expenses would also necessarily be extended to state agencies that would have to enforce and
oversee the handling of any such animal disposal.
We respectfully submit that there is no evidence that warrants such grave action set forth by the
above referenced proposal.
Yours truly,
Hyde Slaughter House, Inc.
Cc: Griffin Industries
Cc: AAMP


http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000373-vol35.pdf


517 VALE WOOD ROAD, LORETTO, PENNSYLVANIA 15940
171 0 1 X300-86 l-6455
December 1,2805
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Docket No. 2002N-0273
RIN 0910-AF46
To Whom It May Concern:
I am writing to express my family dairy farm’s opposition to the proposed FDA rule regarding the
use of cattle materials in all animal feed. More specifically, I oppose the prohibition of using “the
entire carcass of cattle not inspected and passed for human consumption if the brains and spinal
cords have not been removed.” This provision would create unnecessary hardship on our family
farm and would eliminate our ability to economically dispose of dead animals. Because of the high
level of care that we give our animals, our farm mortalities are minimal. Even so, every family
farm must have a safe and affordable method of disposing of mortalities.
There does not appear to be any scientific reason to change the rule that has been in place since
1997. The current rule for testing and surveillance appears to be working, with 99% livestock
industry compliance.
The new rule would cause companies that accept dead animals to either discontinue their service
or to charge such high rates that it would no longer be economically affordable for family farmers
to use their disposal services. In introducing the Proposed Rule, Dr. Andrew von Eschenbach said
that “these additional measures.. .will make an already small risk even s er. ..” Any =gind
benefit of tighter requirements is not economically justifiable due to the disproportionately large
costs to our nation’s livestock producers.
In the not-so-distant past, we used to be able to dispose of farm mortalities 10calIy at no cost.
Under the existing regulations today? our onIy alterrative is to call o?re out-of-state company that
charges $40 per stop. If this company is forced to discontinue its recycling business, we literally
will have no alternative but to begin some type of on-farm burial or compost site for mortalities.
Surely the public health and environmental impact of thousands of small farms having to
independently handle their animal mortalities would be far worse than any marginal benefit of
tightening the existing regulation.
The new rule puts an undue burden on what is already an economically marginal business and is
unnecessary given the current level of scientific knowledge. On behalf of my family dairy farm, I
strongly urge the FDA not to adopt this new rule.
Sincerely,
Carissa Itle Westric
Vale Wood Farms
carissa@valewoodfarms.com


http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000347-vol31.pdf


http://www.fda.gov/ohrms/dockets/dailys/05/Dec05/120705/120705.htm


0244 5 DEC-5 P2:07 -
November 9.2005
Division of Dockets
Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. IO61
Rockville, MD 20852
Dear Sir;
We understand that FDA has proposed to eliminate animal protein in animal
feeds. Previously, in 1997, FDA created a ruminant-to-ruminant feeding ban to reinforce
efforts to reduce the risk of BSE in the United States. This program has been successful
with over 99.5% compliance by the feed industry, rendering industry and those who use
feed in the United States.
It appears that additional regulation of animal protein feeding is unwarranted for
reducing the risk of BSE. Restrictions of animal movement into the United States from
other countries and testing of suspect animals has been sufficient to keep the threat of
BSE very low.
The Harvard University BSE assessment study, headed by Dr. Grey, clearly
showed that the BSE threat in the United States is very low, so low that it is practically
impossible to calculate.
These proposed restrictions are financially and environmentally disastrous to the
United States Agricultural Community. The restriction will result in cessation of dead
animal removal in Kentucky and other states creating a greater risk to the general public.
Livestock producers and dairymen will have nowhere to turn for disposal. There will be
increased human exposure to pathogens through handling of dead animals, polluted
streams and danger to pets and wildlife.
There is no need for further restrictions to protect citizens of the United States.
The current ruminant-to-ruminant ban is sufficient to reduce the risk of BSE. Also.
current USDA surveillance shows we do not have a BSE risk in the United States cattle
population.
We urge you to support the agricultural community and not allow these proposed
restrictions to become effective.
/ Gary Lane,(Ph.D., PAS, Dpl., ACAN
Director of Technical Service c 343
%JRKMANNM~LLS
1111 Perrywlle Road TEL 859-236-0400
Danville, KY 40422 FAX 859-236-7307
U’UJU~ hurkmann co,)r’

http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000343-01-vol31.pdf


ALFALFA COUNTY FEEDERS, INC.
P.O. BOX 246
Ii1 * * 8
TOM KRAUS CHAD MATHEWS
MANAGER ASSISTANT MANAGER
November 30,2005
Food and Drug Administration
5630 Fishers Lane
Room 1061
Rockville, MD 20852
Docket No. 2002N-0273
RIN 091 O-AF46
To Whom It May Concern:
I am writing to express my opposition to the proposed FDA rule regarding the use of cattle
materials in animal feed. This new rule would potentially create an unnecessary hardship on
farmers and cattle producers in the U.S. by removing the means to economically dispose of
dead animals.
There does not appear to be any scientific reason to change the rule that has been in place
and working since 1997. The current government’s testing program has tested over 500,000
animals and only one has tested positive for BSE. The one positive test was in an animal
that was born before the current rule went into effect. No material from that animal got into
the feed chain. The current rule for testing and surveillance is working.
The new rule will force the companies that take dead animals for feed use to stop that
practice or to charge such high rates that it would put a serious economic strain on the
farmers and cattle producers. The alternative disposal means, such as burying the animals,
are also expensive and a potential environmental disaster. We will see much tighter
environmental regulations and fewer places to dispose of the material.
The new rule puts an undue burden on what is an already economically marginal business
and is unnecessary given the current level of scientific knowledge. I strongly urge the FDA
not to adopt the new rule.
Sincerely,
ALFALFA COUNTY FEEDERS, INC.
Tom Kraus
Manager
c 333


http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000333-vol31.pdf


C 327 Maury County Government Vol #: 28


http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000327-01-vol28.pdf

4705 Leland Drivs Gumming, GA 30041
770-886-2250 Phone 770-886-2296 Fax
November 21,2QW
To: Division of Dockets h/tan
Food and Drug Admiflis~~~tu~
5630 Fishers Lane
Room 1062
Rockvilte, tVtb 20852
From: in Custer
Vice Pr~sid~~~
American Piofeins, Inc.
Regarding:
hibited from Use in Animal Food or Feed
Dear Sir or Madame:
1, Brain and spinal cord from ca
2. Cattle not inspected
not ‘i
w~s~rn~~~ff
nonam by late
3. Mechanicat t~s~~arat~d c
4. Taffuw
This document will ad
The current regulation, as a final r&3 in 1997,
stated objective:
Harvard Risk Asse
spontaneously in cd
on to two cases
The current feed @I and’ un
this material, ancl like
negative consequences ~e~at~v~ to the env~~o~me~t~ anjma~, and
human health.
customers of ou
moda!& (@32,000,
in Georgia and Ala
this material would
moved from that
Sincereiy,
Kevin Custer
Vice President
Technical SetviCes


http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000302-01-vol28.pdf


C 271 Center for Biosecurity, Food Safety, & Public Health (CBFSPH) Vol #: 27

http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000271-01-vol27.pdf


C 275 Maryland Cattlemen's Association, Inc. Vol #: 27

http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000275-01-vol27.pdf

November 282005
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Docket #2002N-0273
RIN 091 O&F46
To Whom It May Concern,
I am writing to express our opposition to the proposed FDA rule regarding the use of cattle materials in
animal feed. This new rule will create an unnecessary hardship on Maryland ers and cattle
producers by removing their means of economically disposing of deadstock.
Clearly, the existing science does not support this proposed change to a rule which has been in place,
and by all accounts, working well since 1997. The current testing protocol has examined over 500,000
animals with only one single positive BSE result. That single positive result was confirmed to be in
tissue from an animal born before the current feed rule went into affect. And, due to the existing layered
firewalls, no material from that ‘animal ever entered the feed or food chain, e current rule for testing
and surveillance is working.
The specific impact of the proposed change to the existing rule will be either the total halting of all
deadstock retrieval by rendering companies or, the need to institute a signi~ca~tl~ higher fee structure
for any future retrieval. Higher costs of disposal will create a serious financial burden on cattle
producers and will discourage the use of future disposal services. Farmers will be forced to seek
alternative disposal means, for example burying, which could create unwanted environmental damage
and associated negative health impacts.’ Wehave a system in place under the current rule that has proven
itself and is working well. It is a system that works without placing undue eeunomic burden on our cattle
producers.
In summary, we see no scientific data to support the proposed rule change. Conversely, we recognize
several years of data to substantiate to effectiveness af the current rule. The proposed change is not
needed and we strongly urge the FDA to NOT ADOPT the proposed rule changes,
S&Ott M. Barao, Ph.D.
Executive Director.
CC: Senators Sarbanes and Mikulski


http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000275-01-vol27.pdf


C 281 West Virginia Custom Cuts, LLC Vol #: 27


http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000281-01-vol27.pdf


C 138 Reddemeade Farm, Inc. Vol #: 21

http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000138-01-vol21.pdf


C 118 Pet Food Institute (PFI) Vol #: 17


http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000118-01-vol21.pdf


C 93 Embry Farm Service Vol #: 17


http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000093-vol17.pdf


2002N-0273 Animal Proteins Prohibited in Ruminant Feed EC 36 Mr. Michael Hippert Vol #: 4 EC 37 Karem, Inc. Vol #: 4 EC 38 Dr. Robin Appel

http://www.fda.gov/ohrms/dockets/dailys/05/Nov05/111805/111805.htm#02N0273


2002N-0273 Animal Proteins Prohibited in Ruminant Feed C 56 South Dakota Department of Agriculture Vol #: 4

http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000056-01-vol4.pdf

2004N-0264 Federal Measures to Mitigate BSE Risks: Considerations for Further Action C 209 Texas Association of Business Vol #: 23


http://www.fda.gov/ohrms/dockets/dockets/04n0264/04n-0264-c000209-01-vol23.pdf


2002N-0273 Animal Proteins Prohibited in Ruminant Feed EC 35 Mrs. Carla Yelkovan Vol #: 4

http://www.fda.gov/ohrms/dockets/dockets/02n0273/02N-0273-EC35.htm

2002N-0273 Animal Proteins Prohibited in Ruminant Feed
EMC 14 B Sachau Vol #: 14
EMC 15 Number not used Vol #: 14
EMC 16 Union of Concerned Scientists Vol #: 14

http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273_emc-000016.txt

2004N-0081 BSE Risk Materials in Foods and Cosmetics EMC 1147 I. Licea Vol #: 15


http://www.fda.gov/ohrms/dockets/dailys/05/Oct05/102705/102705.htm

2004N-0081 BSE Risk Materials in Foods and Cosmetics
EMC 1146 Pfizer Inc Vol #: 15

IN CONCLUSION, it is Pfizer's recommendation that the Interim Final Rule could be strengthened by INCLUDING the following:

1) For production of tallow derivatives, stress the importance of the rigorousness of the processing (transesterification or saponification) in minimizing the risk of transmitting TSE agents.

2) PROHIBIT the use of small intestine in materials for use in human food and cosmetics. ...

snip...


http://www.fda.gov/ohrms/dockets/dockets/04n0081/04N-0081_EMC1146-02.pdf

2004N-0081 BSE Risk Materials in Foods and Cosmetics C 150 The Dow Chemical Company (Dow) Vol #: 13

http://www.fda.gov/ohrms/dockets/dockets/04n0081/04n-0081-c000150-01-vol13.pdf

03-025IFA
03-025IFA-2
Terry S. Singeltary


From: Terry S. Singeltary Sr. [flounder9@verizon.net] Sent: Thursday, September 08, 2005 6:17 PM To: fsis.regulationscomments@fsis.usda.gov 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


snip...


THE infamous USA SPORADIC CJDs, something to ponder; IF the USA TSE in cattle all does not look like UK BSE, why would all USA human TSE look like UK nvCJD??? over 20 strains of scrapie documented to date with new atypical strains now being documented in sheep and goat i.e. BSE. atypical strains of BSE/TSE showing up in cattle in different countries? ALL animals for human/animal consumption must be tested for TSE. ALL human TSEs must be made reportable Nationally and Internationally, OF ALL AGES... IN a time when FSIS/APHIS/USDA/FDA et al should be strengthening the TSE regulations, it seems corporate interest has won out again over sound science and consumer protection from an agent that is 100% fatal for the ones that go clinical. With the many different atypical TSEs showing up in different parts of the world, and with GWs BSE MRR policy (the legal policy of trading all strains of TSEs), the battle that has waged for the last 25 years to eradicate this agent from this planet will be set back decades, if not lost for good. ... 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


TSS


----- Original Message -----
From: "Terry S. Singeltary Sr."
To:
Sent: Wednesday, January 04, 2006 5:37 PM
Subject: Re: Group: U.S. not protected against mad cow


> ##################### Bovine Spongiform Encephalopathy #####################
>
> International Scientific Advisory Council
> McDonald's International Scientific Advisory Council adds further strength
> to our beef safety program by providing independent expert scientific and
> medical advice on bovine spongiform encephalopathy (BSE).
>
> COUNCIL MEMBERS
>
> Dr. Neil Cashman. Diener Professor of Neurodegenerative Diseases and
> Director, Neuromuscular Disease Clinic, Sunnybrook & Women's Health Sciences
> Center, University of Toronto. Specialist in motor neuron diseases and the
> cell biology of amyloid encephalopathies, including prion illnesses. Author
> of over 250 publications. Recipient of the 2000 Jonas Salk Prize for
> biomedical research.
>
> Dr. Dean Danilson. Vice President QAFS, Tyson Foods, Inc. Responsible for
> quality assurance and food safety programs for the retail division for fresh
> beef, pork, poultry and ready-to-eat meats.
>
> Dr. Linda Detwiler. Adjunct Professor, Virginia-Maryland Regional College of
> Veterinary Medicine, University of Maryland. Also provides private animal
> health consulting services, with specializations in transmissible spongiform
> encephalopathies, emergency preparedness, and animal product issues related
> to imports and exports. Formerly Senior Staff Veterinarian, Emergency
> Programs Staff, U.S. Department of Agriculture Animal and Plant Health
> Inspection Service, the unit principally responsible for surveillance,
> prevention, and education activities related to BSE. Member of various
> international working groups and advisory committees on TSEs. Author of
> numerous articles on the issues.
>
> Alan A. Harris, M.D. Professor of Internal Medicine and Preventive Medicine,
> Senior Assistant Chairman, Department of Internal Medicine, Hospital
> Epidemiologist, Rush-Presbyterian-St. Luke's Medical Center. Specialist in
> public health and foodborne illnesses. Fellow, Infectious Diseases Society
> of America. Fellow, American College of Physicians. Member, Society of
> Healthcare Epidemiology of America. Author or co-author of more than 140
> scientific publications.
>
> Dr. Beat Hörnlimann, MPH. Managing Director, SVISS Consulting, BSE 7192
> Ltd., an organization that provides expert advice on public and animal
> health, particularly with respect to BSE. Formerly Chief Veterinary Officer,
> Public Health Department, Kanton Zug, Switzerland. Led Swiss BSE and scrapie
> eradication program and served in numerous other senior-level staff and
> advisory positions related to TSEs. Author of a book on prions and prion
> diseases in humans and animals.
>
> Dr. David Kessler. Dean, School of Medicine, Yale University and former
> Commissioner, U.S. Food and Drug Administration. Author of A Question of
> Intent (on federal tobacco regulation efforts) and numerous articles in
> major medical journals. Member, Board of Directors, Elizabeth Glaser
> Pediatric AIDS Foundation, Doctors of the World, National Center for
> Addiction and Substance, Henry Kaiser Family Foundation. Recipient of
> numerous medical public service awards, including the American Heart
> Association National Public Affairs Special Recognition Award, American
> Academy of Pediatrics Excellence in Public Service Award, and American
> Cancer Society Medal of Honor.
>
> Dr. Colin Masters. Professor and Head, Department of Pathology, University
> of Melbourne. Specialist in neuropathology. Member, numerous national and
> international medical professional societies.
>
> Dr. Carols Messuti. Ministry of Livestock, Agriculture, and Fishing,
> Government of Uruguay and Delegate to the OIE, the UN's principal agency for
> animal diseases.
>
> Dr. Jeffrey W. Savell. Professor, E.M. ?Manny? Rosenthal Chairholder, and
> Leader, Meat Science Section, Department of Animal Science, Texas A&M
> University. Specialist in meat quality/consistency, food safety and
> nutrition. Past President, American Meat Science Association; member,
> Institute of Food Technologists, American Society of Animal Science, HACCP
> Alliance. Author or co-author of more than 250 articles and co-author of the
> Laboratory Manual for Meat Science. Recipient of numerous awards for
> research and teaching.
>
> Dr. James Toole. Walter C. Teagle Professor of Neurology, Professor of
> Public Health Sciences, and Director, Stroke Research Center, Wake Forest
> University School of Medicine. President, International Stroke Society;
> member and past-president, World Federation of Neurology; member and
> past-president American Neurological Association; fellow, Royal College of
> Physicians; master, American College of Physicians. Author of
> Cerebrovascular Disorders and over 600 medical textbook chapters; co-editor
> Handbook of Clinical Neurology. Former editor, Journal of the Neurological
> Sciences.
>
>
> http://www.mcdonalds.com/corp/values/socialrespons/resrecog/expert_advisors0
> /international_scientific.html
>
>
> 06/09/05
> BSE Roundtable Discussion Transcript
>
>
> http://www.aphis.usda.gov/lpa/issues/bse/BSE_roundtable_6_9_05.pdf
>
>
> NOW, let us look at another BSE ROUNDTABLE DISCUSSION by USDA et al in the
> year 2003, please note the BSE science on IHC testing then, and then compare
> to now, and then ponder those other 9,200 cattle of the infamous June 2004
> BSE cover-up program, that did not have rapid testing or WB, just IHC, the
> lease likely to find BSE/TSE ;
>
>
> USDA 2003
>
> We have to be careful that we don't get so set in the way we do things that
> we forget to look for different emerging variations of disease. We've gotten
> away from collecting the whole brain in our systems. We're using the brain
> stem and we're looking in only one area. In Norway, they were doing a
> project and looking at cases of Scrapie, and they found this where they did
> not find lesions or PRP in the area of the obex. They found it in the
> cerebellum and the cerebrum. It's a good lesson for us. Ames had to go
> back and change the procedure for looking at Scrapie samples. In the USDA,
> we had routinely looked at all the sections of the brain, and then we got
> away from it. They've recently gone back.
> Dr. Keller: Tissues are routinely tested, based on which tissue provides an
> 'official' test result as recognized by APHIS
> .
>
> Dr. Detwiler: That's on the slaughter. But on the clinical cases, aren't
> they still asking for the brain? But even on the slaughter, they're looking
> only at the brainstem. We may be missing certain things if we confine
> ourselves to one area.
>
>
> snip.............
>
>
> Dr. Detwiler: It seems a good idea, but I'm not aware of it.
> Another important thing to get across to the public is that the negatives
> do not guarantee absence of infectivity. The animal could be early in the
> disease and the incubation period. Even sample collection is so important.
> If you're not collecting the right area of the brain in sheep, or if
> collecting lymphoreticular tissue, and you don't get a good biopsy, you
> could miss the area with the PRP in it and come up with a negative test.
> There's a new, unusual form of Scrapie that's been detected in Norway. We
> have to be careful that we don't get so set in the way we do things that we
> forget to look for different emerging variations of disease. We've gotten
> away from collecting the whole brain in our systems. We're using the brain
> stem and we're looking in only one area. In Norway, they were doing a
> project and looking at cases of Scrapie, and they found this where they did
> not find lesions or PRP in the area of the obex. They found it in the
> cerebellum and the cerebrum. It's a good lesson for us. Ames had to go
> back and change the procedure for looking at Scrapie samples. In the USDA,
> we had routinely looked at all the sections of the brain, and then we got
> away from it. They've recently gone back.
>
> Dr. Keller: Tissues are routinely tested, based on which tissue provides an
> 'official' test result as recognized by APHIS
> .
>
> Dr. Detwiler: That's on the slaughter. But on the clinical cases, aren't
> they still asking for the brain? But even on the slaughter, they're looking
> only at the brainstem. We may be missing certain things if we confine
> ourselves to one area.
>
>
> snip...
>
>
> FULL TEXT;
>
>
> Completely Edited Version
> PRION ROUNDTABLE
>
>
> Accomplished this day, Wednesday, December 11, 2003, Denver, Colorado
>
>
> 2005
>
>
> National Veterinary Services Laboratory (NVSL) Immunohistochemistry (IHC)
> Testing Summary
>
> The BSE enhanced surveillance program involves the use of a rapid screening
> test, followed by confirmatory testing for any samples that come back
> "inconclusive." The weekly summary below captures all rapid tests conducted
> as part of the enhanced surveillance effort. It should be noted that since
> the enhanced surveillance program began, USDA has also conducted
> approximately 9,200 routine IHC tests on samples that did not first undergo
> rapid testing.
>
>
> http://www.aphis.usda.gov/lpa/issues/bse_testing/test_results.html
>
>
> http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf
>
>
> TSS
>
>
> TSS
> ----- Original Message -----
> From: "Terry S. Singeltary Sr."
> To:
> Sent: Wednesday, January 04, 2006 5:14 PM
> Subject: Group: U.S. not protected against mad cow
>
>
> ##################### Bovine Spongiform Encephalopathy
> #####################
>
> Posted on Wed, Jan. 04, 2006
>
> Group: U.S. not protected against mad cow
> LIBBY QUAID
> Associated Press
> WASHINGTON - Researchers and the nation's No. 1 burger seller say the
> government is not fully protecting animals or people from mad cow disease.
>
> Stronger steps are needed to keep infection from entering the food chain for
> cattle, the critics wrote in comments to the Food and Drug Administration.
>
> The group includes McDonald's Corp., seven scientists and experts and a
> pharmaceutical supplier, Serologicals Corp.
>
> The government proposed new safeguards two months ago, but researchers said
> that effort "falls woefully short" and would continue to let cattle eat
> potentially infected feed, the primary way mad cow disease is spread.
>
> "We do not feel that we can overstate the dangers from the insidious threat
> from these diseases and the need to control and arrest them to prevent any
> possibility of spread," the researchers wrote.
>
> McDonald's said the risk of exposure to the disease should be reduced to
> zero, or as close as possible. "It is our opinion that the government can
> take further action to reduce this risk," wrote company Vice President Dick
> Crawford.
>
> In people, eating meat or cattle products contaminated with mad cow disease
> is linked to a rare but fatal nerve disorder, variant Creutzfeldt-Jakob
> Disease.
>
> No one is known to have contracted the disease in the United States. The
> disease has turned up in two people who lived in the U.S., but it's believed
> they were infected in the United Kingdom during an outbreak there in the
> 1980s and 1990s.
>
> The U.S. has found two cases of mad cow disease in cows. Since the first
> case, confirmed in December 2003 in a Canadian-born cow in Washington state,
> the government has tested more than half a million of the nation's 95
> million cows. The second case was confirmed last June in a Texas-born cow.
>
> "While this surveillance has not uncovered an epidemic, it does not clear
> the U.S. cattle herd from infection," the researchers said.
>
> The primary firewall against mad cow disease is a ban on using cattle
> remains in cattle feed, which the U.S. put in place in 1997. However, the
> feed ban has loopholes that create potential pathways for mad cow disease.
> For example, using restaurant plate waste is allowed in cattle feed.
>
> The Food and Drug Administration proposed in October to tighten the rules,
> but critics said glaring loopholes would remain.
>
> The FDA, which regulates animal feed, accepted public comments on the
> proposal through last month. An agency spokeswoman said Wednesday it would
> be inappropriate to respond to those comments.
>
> The critics said their biggest concern is that tissue from dead animals
> would be allowed in the feed chain if brains and spinal cords have been
> removed. Brains and spinal cords are tissues that can carry mad cow disease.
>
> In dead cattle that had the disease, infection had spread beyond brains and
> spinal cords. Leaving tissue from dead cattle in the feed chain would negate
> FDA's attempt to strengthen its safeguards, the critics said.
>
> The most effective safeguards, they said, would be to:
>
> _Ban from animal feed all tissues considered "specified risk materials" by
> the Agriculture Department, which requires that such materials be removed
> from meat that people eat. This includes tissues beyond the brain and spinal
> cord, such as eyes or part of the small intestine.
>
> _Ban the use of dead cattle in animal feed.
>
> _Close loopholes allowing plate waste, poultry litter and blood to be fed
> back to cattle.
>
> Within the meat industry, many say the FDA proposal is effective, although
> some companies contend new rules are unneeded. The American Meat Institute
> Foundation, which represents meat processing companies, backs the FDA
> proposal.
>
> "To take out the most potentially infected material, and that would be
> brains and spinal cords, that removes about 90 percent of the potential
> infectivity that is in an animal - if it's infected," said Jim Hodges, AMI
> Foundation president.
>
> Mad cow disease is the common name for bovine spongiform encephalopathy, or
> BSE, a degenerative nerve disease in cattle.
>
> ON THE NET
>
> Food and Drug Administration: http://www.fda.gov
>
> American Meat Institute: http://www.meatami.com/
>
>
> http://www.duluthsuperior.com/mld/duluthsuperior/living/health/13549744.htm
>
>
> TSS
>
>
>
>
>
> January 3, 2006 — FDA Veterinarian Newsletter -July/August 2005, Volume XX,
> No. IV
>
>
> snip...
>
>
> FDA Proposes Tighter Feed Ban to Prevent BSE
>
>
> The Food and Drug Administration on October 6 proposed banning certain
> high-risk cattle material from all animal feeds, including pet food, to
> strengthen safeguards against bovine spongiform encephalopathy (BSE).
>
> The proposed rule would add requirements to the 1997 feed rule, which bans
> most mammalian protein from use in feed for cattle and other ruminants. The
> rule proposes to eliminate 90 percent of all potentially infectious material
> from the feed supply.
>
> The proposed rule would ban from all feed:
>
> Brains and spinal cord of cattle 30 months old or older.
>
> Brains and spinal cord of cattle not inspected and passed for human
> consumption.
>
> The entire carcass of cattle not inspected and passed for human consumption
> if the brain and spinal cord has not been removed.
>
> Tallow, if it is derived from the material that would be prohibited under
> this rule and contains more than 0.15 percent insoluble impurities.
>
> Mechanically separated beef derived from material that would be prohibited
> under this rule.
>
> The proposed rule is designed to prevent any possible “leakage” of potential
> infectious material into cattle feed. The 1997 rule prohibits the use of
> most mammalian protein in feed for cattle and other ruminants, but allows
> the use of the protein, including the brain and spinal cord, in feeds for
> swine and poultry. The proposed rule would prevent the highest risk material
> from entering any part of the feed chain. Therefore, it is unlikely to find
> its way, by accident or deliberately, into feed for cattle.
>
>
> FDA believes that the 1997 feed rule has been extremely effective. However,
> with the discovery of BSE in the United States, FDA officials decided to
> further strengthen the measures already in place.
>
> Earlier position
>
> In January 2004, FDA announced it was planning to take other steps to
> address the BSE situation, including banning the use of poultry litter,
> plate waste, and blood and blood products in cattle feed. FDA also said it
> was planning to require dedicated facilities for handling feed and feed
> ingredients for ruminant animals.
>
>
> However, after further consideration, including recommendations from an
> International Review team convened by USDA to assess the controls in place
> to prevent the spread of BSE, FDA concluded that banning plate waste,
> poultry litter, and blood and requiring dedicated facilities are not needed
> if high risk tissues are excluded from animal feed channels. By keeping the
> high-risk material out of all feed, none could be spilled into poultry
> litter, so that route would be blocked. BSE rules by USDA’s Food Safety
> Inspection Service (FSIS) and FDA’s Center for Food Safety and Applied
> Nutrition (CFSAN) address food safety by keeping potentially infectious
> material out of food, thus eliminating plate waste as a possible vehicle.
> Blood has not been shown to be a vehicle for BSE infection, so it was not
> included in the proposed rule. (In addition, international standard setting
> agencies believe blood products are as safe for use in animal feed as milk
> and milk products.) And separate, dedicated facilities would not be needed
> because the proposed rule would eliminate the high-risk material, thus
> eliminating the concern for contamination of cattle feed.
>
>
> The proposal would cost the industry approximately $14 million to $24
> million per year, annualized over a 10-year period. This estimate includes
> the cost of complying and the cost of substitute feeds.
>
>
> The comment period for the rule closes December 20, 2005. Comments should be
> identified by Docket Number 2002N-0273, or RIM 0901-AF46. They can be
> submitted electronically through the Federal eRulemaking Portal:
> http://www.regulations.gov, or through the Agency website at
> http://www.fda.gov/dockets/ecomments.
>
>
> Written comments can be submitted via fax at 301-827-6870; or mailed, hand
> delivered, or sent by courier as a paper copy, on a disk or a CD-ROM, to
> Division of Dockets Management (HFA-305), Food and Drug Administration, 5630
> Fishers Lane, Rockville, MD 20852. The comments may be posted publicly on
> FDA’s dockets, including any personal information submitted with the
> comment.
>
> U.S. Completes Investigation of BSE-Infected Cow in Texas
>
>
> After investigating the report of a cow in Texas found in June to be
> infected with bovine spongiform encephalopathy (BSE), Federal officials
> reported that appropriate safeguards were in place and working, which
> prevented the further spread of the disease.
>
>
> The infected animal was destroyed and did not get into the food, feed, or
> pet food supply, officials said. This was the first native born cow in the
> United States found to be infected with BSE.
>
>
> The U.S. Department of Agriculture (USDA), which is in charge of tracking
> and preventing animal disease, reported the infected animal to the Food and
> Drug Administration (FDA) on June 24, 2005. To determine if any other
> animals or offspring of animals from the herd of the infected animal were
> infected with BSE, USDA tracked down as many as it could of the 200 adult
> and 213 calves associated with the infected animals. No additional BSE was
> found.
>
>
> Meanwhile, FDA officials, along with the Texas Animal Health Commission and
> the Texas Feed and Fertilizer Control Service, investigated the sources of
> feed given the infected animal to see if they could discover the source of
> the infectious material. In addition, the Federal and State authorities
> tracked the disposition of all animals associated with the infected cow to
> be sure the provisions of FDA’s 1997 BSE rule were followed.
>
>
> The investigation concluded that the 1997 feed rule, which prohibits the
> feeding of most mammalian protein to cattle and other ruminants, was being
> followed. At an August 30 press teleconference, Dr. Stephen Sundlof,
> director of FDA’s Center for Veterinary Medicine, said that the
> investigation revealed that all companies involved were complying with the
> 1997 BSE feed rule.
>
>
> FDA’s investigation identified 21 feed products used on the farm. FDA and
> State investigators went to three retail feed stores that had supplied the
> feed, and to nine feed mills that made the feed. According to Dr. Sundlof,
> “This investigation found no feed products used on the farm since 1997 had
> been formulated to contain prohibited mammalian protein.”
>
>
> According to Dr. Sundlof, the infected cow, which was approximately 12 years
> old, had “very likely consumed contaminated feed well before 1997….”
>
>
> The animals associated with the infected cow were properly handled during
> slaughter and disposition under the feed rule, Dr. Sundlof said: “The
> investigation into the disposition of herd-mates from this farm involved
> visits to nine slaughter plants and eight rendering plants. The
> investigation found that all rendering plants were operating in compliance
> with the BSE ruminant feed rule. A review of the inspection history of each
> of these rendering firms found no violation.”
>
>
> On October 6, FDA announced proposed rules to further reduce the risk of BSE
> in the United States. The proposal would ban certain high risk cattle
> material from use in all feeds and pet foods. (See related story on page 1,
> “FDA Proposes Tighter Feed Ban to Prevent BSE.”)
>
>
>
> http://www.fda.gov/cvm/FdaVetJulAug2005.htm
>
>
>
>
> > The investigation concluded that the 1997 feed rule, which prohibits the
> feeding of
>
>
> > most mammalian protein to cattle and other ruminants, was being followed.
>
>
>
>
> FOR IMMEDIATE RELEASE
> P01-05
> January 30, 2001
> Print Media: 301-827-6242
> Consumer Inquiries: 888-INFO-FDA
>
>
> ----------------------------------------------------------------------------
> ----
>
> Note: On Dec. 23, 2003, the U.S. Department of Agriculture reported that a
> cow in Washington state had tested positive for bovine spongiform
> encephalopathy (BSE, or mad cow disease). As a result, information on this
> Web page stating that no BSE cases had been found in the United States is
> now incorrect. However, because other information on this page continues to
> have value, the page will remain available for viewing.
>
> FDA ANNOUNCES TEST RESULTS FROM TEXAS FEED LOT
>
>
> Today the Food and Drug Administration announced the results of tests taken
> on feed used at a Texas feedlot that was suspected of containing meat and
> bone meal from other domestic cattle -- a violation of FDA's 1997
> prohibition on using ruminant material in feed for other ruminants. Results
> indicate that a very low level of prohibited material was found in the feed
> fed to cattle.
>
> FDA has determined that each animal could have consumed, at most and in
> total, five-and-one-half grams - approximately a quarter ounce -- of
> prohibited material. These animals weigh approximately 600 pounds.
>
> It is important to note that the prohibited material was domestic in origin
> (therefore not likely to contain infected material because there is no
> evidence of BSE in U.S. cattle), fed at a very low level, and fed only once.
> The potential risk of BSE to such cattle is therefore exceedingly low, even
> if the feed were contaminated.
>
> According to Dr. Bernard Schwetz, FDA's Acting Principal Deputy
> Commissioner, "The challenge to regulators and industry is to keep this
> disease out of the United States. One important defense is to prohibit the
> use of any ruminant animal materials in feed for other ruminant animals.
> Combined with other steps, like U.S. Department of Agriculture's (USDA) ban
> on the importation of live ruminant animals from affected countries, these
> steps represent a series of protections, to keep American cattle free of
> BSE."
>
> Despite this negligible risk, Purina Mills, Inc., is nonetheless announcing
> that it is voluntarily purchasing all 1,222 of the animals held in Texas and
> mistakenly fed the animal feed containing the prohibited material.
> Therefore, meat from those animals will not enter the human food supply. FDA
> believes any cattle that did not consume feed containing the prohibited
> material are unaffected by this incident, and should be handled in the beef
> supply clearance process as usual.
>
> FDA believes that Purina Mills has behaved responsibly by first reporting
> the human error that resulted in the misformulation of the animal feed
> supplement and then by working closely with State and Federal authorities.
>
> This episode indicates that the multi-layered safeguard system put into
> place is essential for protecting the food supply and that continued
> vigilance needs to be taken, by all concerned, to ensure these rules are
> followed routinely.
>
> FDA will continue working with USDA as well as State and local officials to
> ensure that companies and individuals comply with all laws and regulations
> designed to protect the U.S. food supply.
>
>
>
> ----------------------------------------------------------------------------
> ----
>
>
> http://www.fda.gov/bbs/topics/NEWS/2001/NEW00752.html
>
>
> NEWS RELEASE
>
> Texas Animal Health Commission
>
> Box l2966 •Austin, Texas 78711 •(800) 550-8242• FAX (512) 719-0719
>
> Linda Logan, DVM, PhD• Executive Director
>
> For info, contact Carla Everett, information officer, at 1-800-550-8242,
> ext. 710,
>
> or ceverett@tahc.state.tx.us
>
> For Immediate Release--
>
> Feed Contamination Issue Resolved by FDA
>
> Although many of you may have heard the latest regarding the resolution of
> the cattle feed
>
> contamination situation in Texas, I wanted to ensure that you received this
> statement issued
>
> by the Food and Drug Administration (FDA), the agency in charge of
> regulating feed
>
> components. The FDA has said the cattle involved are to be rendered and the
> material will not
>
> enter ruminant or human food channels. The Texas Animal Health Commission
> (TAHC) will
>
> provided assistance to the FDA as requested and needed.
>
> FDA ANNOUNCES TEST RESULTS FROM TEXAS FEED LOT
>
> Today (Tuesday, Jan. the Food and Drug Administration announced the results
> of tests taken
>
> on feed used at a Texas feedlot that was suspected of containing meat and
> bone meal from
>
> other domestic cattle -- a violation of FDA's 1997 prohibition on using
> ruminant material in
>
> feed for other ruminants. Results indicate that a very low level of
> prohibited material was
>
> found in the feed fed to cattle.
>
> FDA has determined that each animal could have consumed, at most and in
> total,
>
> five-and-one-half grams - approximately a quarter ounce -- of prohibited
> material. These
>
> animals weigh approximately 600 pounds.
>
> It is important to note that the prohibited material was domestic in origin
> (therefore not likely
>
> to contain infected material because there is no evidence of BSE in U.S.
> cattle), fed at a very
>
> low level, and fed only once. The potential risk of BSE to such cattle is
> therefore exceedingly
>
> low, even if the feed were contaminated.
>
> According to Dr. Bernard Schwetz, FDA's Acting Principal Deputy
> Commissioner, "The
>
> challenge to regulators and industry is to keep this disease out of the
> United States. One
>
> important defense is to prohibit the use of any ruminant animal materials in
> feed for other
>
> ruminant animals. Combined with other steps, like U.S. Department of
> Agriculture's (USDA)
>
> ban on the importation of live ruminant animals from affected countries,
> these steps represent
>
> a series of protections, to keep American cattle free of BSE."
>
> Despite this negligible risk, Purina Mills, Inc., is nonetheless announcing
> that it is voluntarily
>
> purchasing all 1,222 of the animals held in Texas and mistakenly fed the
> animal feed
>
> containing the prohibited material. Therefore, meat from those animals will
> not enter the
>
> human food supply. FDA believes any cattle that did not consume feed
> containing the
>
> prohibited material are unaffected by this incident, and should be handled
> in the beef supply
>
> clearance process as usual.
>
> FDA believes that Purina Mills has behaved responsibly by first reporting
> the human error
>
> that resulted in the misformulation of the animal feed supplement and then
> by working
>
> closely with State and Federal authorities.
>
> This episode indicates that the multi-layered safeguard system put into
> place is essential for
>
> protecting the food supply and that continued vigilance needs to be taken,
> by all concerned, to
>
> ensure these rules are followed routinely.
>
> FDA will continue working with USDA as well as state and local officials to
> ensure that
>
> companies and individuals comply with all laws and regulations designed to
> protect the U.S.
>
> food supply.
>
> ---30--
>
>
> http://www.tahc.state.tx.us/news/pr/2001/101FEED_ISSUE_RESOLVED.pdf
>
>
> 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 primates
>
> 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 Deslys
>
> 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.
>
>
> snip...
>
>
> 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 (icip 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.
> icip=intracerebral and intraperitoneal.
>
> Table 1: Comparison of transmission rates in primates and cattle infected
> orally with similar BSE brain inocula
>
>
> snip...
>
>
> www.thelancet.com Published online January 27, 2005 http://image.thelancet.c
> om/extras/05let1056web.pdf
>
>
>
>
> #1 TEJAS MAD COW THAT WAS NOT TESTED AT ALL!
>
> FDA Statement
> FOR IMMEDIATE RELEASE
> Statement
> May 4, 2004
> Media Inquiries: 301-827-6242
> Consumer Inquiries: 888-INFO-FDA
>
>
> Statement on Texas Cow With Central Nervous System Symptoms
> On Friday, April 30 th , the Food and Drug Administration learned that a cow
> with central nervous system symptoms had been killed and shipped to a
> processor for rendering into animal protein for use in animal feed.
>
> FDA, which is responsible for the safety of animal feed, immediately began
> an investigation. On Friday and throughout the weekend, FDA investigators
> inspected the slaughterhouse, the rendering facility, the farm where the
> animal came from, and the processor that initially received the cow from the
> slaughterhouse.
>
> FDA's investigation showed that the animal in question had already been
> rendered into "meat and bone meal" (a type of protein animal feed). Over the
> weekend FDA was able to track down all the implicated material. That
> material is being held by the firm, which is cooperating fully with FDA.
>
> Cattle with central nervous system symptoms are of particular interest
> because cattle with bovine spongiform encephalopathy or BSE, also known as
> "mad cow disease," can exhibit such symptoms. In this case, there is no way
> now to test for BSE. But even if the cow had BSE, FDA's animal feed rule
> would prohibit the feeding of its rendered protein to other ruminant animals
> (e.g., cows, goats, sheep, bison).
>
> FDA is sending a letter to the firm summarizing its findings and informing
> the firm that FDA will not object to use of this material in swine feed
> only. If it is not used in swine feed, this material will be destroyed. Pigs
> have been shown not to be susceptible to BSE. If the firm agrees to use the
> material for swine feed only, FDA will track the material all the way
> through the supply chain from the processor to the farm to ensure that the
> feed is properly monitored and used only as feed for pigs.
>
> To protect the U.S. against BSE, FDA works to keep certain mammalian protein
> out of animal feed for cattle and other ruminant animals. FDA established
> its animal feed rule in 1997 after the BSE epidemic in the U.K. showed that
> the disease spreads by feeding infected ruminant protein to cattle.
>
> Under the current regulation, the material from this Texas cow is not
> allowed in feed for cattle or other ruminant animals. FDA's action
> specifying that the material go only into swine feed means also that it will
> not be fed to poultry.
>
> FDA is committed to protecting the U.S. from BSE and collaborates closely
> with the U.S. Department of Agriculture on all BSE issues. The animal feed
> rule provides crucial protection against the spread of BSE, but it is only
> one of several such firewalls. FDA will soon be improving the animal feed
> rule, to make this strong system even stronger.
>
>
> OOPS!..........TSS
>
>
> http://www.fda.gov/bbs/topics/news/2004/NEW01061.html
>
>
> Statement by Chief Veterinary Medical Officer John Clifford Animal and Plant
> Health Inspection Service Regarding Non-Definitive BSE Test Results
> July 27, 2005
>
> snip...
>
>
> The veterinarian treated the sample with a preservative, which readies it
> for testing using the immunohistochemistry (IHC) test —an internationally
> recognized confirmatory test for BSE. Neither the rapid screening test nor
> the Western blot confirmatory test can be conducted on a sample that has
> been preserved.
>
>
> snip...
>
>
> I would note that the sample was taken in April, at which time the protocols
> allowed for a preservative to be used (protocols changed in June 2005). The
> sample was not submitted to us until last week, because the veterinarian set
> aside the sample after preserving it and simply forgot to send it in.
>
>
> http://www.aphis.usda.gov/lpa/news/2005/07/bsestatement_vs.html
>
>
> "Earlier this week, USDA's Office of the Inspector General (OIG), which has
> been partnering with the Animal and Plant Health Inspection Service, the
> Food Safety and Inspection Service, and the Agricultural Research Service by
> impartially reviewing BSE-related activities and making recommendations for
> improvement, recommended that all three of these samples be subjected to a
> second internationally recognized confirmatory test, the OIE-recognized SAF
> immunoblot test, often referred to as the Western blot test. We received
> final results a short time ago. Of the three samples, two were negative, but
> the third came back reactive.
>
> "Because of the conflicting results on the IHC and Western blot tests, a
> sample from this animal will be sent to the OIE-recognized reference
> laboratory for BSE in Weybridge, England. USDA will also be conducting
> further testing, which will take several days to complete.
>
>
> http://www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB?contentidonly=true&con
> tentid=2005/06/0206.xml
>
>
> "Each was then followed up with an IHC test. Each confirmatory IHC test was
> negative. The Inspector General, in reviewing our surveillance system that
> we have in place, decided to retest with a second confirmatory test which is
> called the Western Blot. We have received test results showing a positive on
> one animal for the Western Blot.
>
>
> http://www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB?contentidonly=true&con
> tentid=2005/06/0207.xml
>
>
> ONE YEAR LATER, not 24 to 96 hours (this is what i call mad cow market
> timing)
>
>
> STATEMENT BY DR. JOHN CLIFFORD REGARDING FURTHER ANALYSIS OF BSE TEST
> RESULTS IN WEYBRIDGE, ENGLAND
> June 16, 2005
>
> "Today, an official with USDA's National Veterinary Services Laboratory
> departed for Weybridge, England, hand-carrying samples for further testing.
>
>
> http://www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB?contentidonly=true&con
> tentid=2005/06/0218.xml
>
>
> "So let me start first with the test results. As you are aware, last
> November we had an inconclusive report from a rapid screening test. USDA
> then conducted two IHC confirmatory tests, and both came out negative. A few
> weeks ago an additional confirmatory test was conducted, and that test is
> referred to as the Western blot test.
>
> "On June 10 I learned that test was reactive and shared those results at
> that time.
>
> "We now have the test results from the lab in Weybridge, England, as well as
> the results from additional testing in our own lab, and again I am here
> today to share those results with you.
>
> "The results confirm the presence of BSE in this animal, an animal that was
> blocked from entering the food supply thanks to the firewalls that are in
> place. It is critically important to note that this animal was identified as
> a high risk animal. A sample was taken, and the carcass was incinerated.
>
>
> http://www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB?contentidonly=true&con
> tentid=2005/06/0233.xml
>
>
> 06/09/05
> BSE Roundtable Discussion Transcript
>
>
> http://www.aphis.usda.gov/lpa/issues/bse/BSE_roundtable_6_9_05.pdf
>
>
> NOW, let us look at another BSE ROUNDTABLE DISCUSSION by USDA et al in the
> year 2003, please note the BSE science on IHC testing then, and then compare
> to now, and then ponder those other 9,200 cattle of the infamous June 2004
> BSE cover-up program, that did not have rapid testing or WB, just IHC, the
> lease likely to find BSE/TSE ;
>
>
> USDA 2003
>
> We have to be careful that we don't get so set in the way we do things that
> we forget to look for different emerging variations of disease. We've gotten
> away from collecting the whole brain in our systems. We're using the brain
> stem and we're looking in only one area. In Norway, they were doing a
> project and looking at cases of Scrapie, and they found this where they did
> not find lesions or PRP in the area of the obex. They found it in the
> cerebellum and the cerebrum. It's a good lesson for us. Ames had to go
> back and change the procedure for looking at Scrapie samples. In the USDA,
> we had routinely looked at all the sections of the brain, and then we got
> away from it. They've recently gone back.
> Dr. Keller: Tissues are routinely tested, based on which tissue provides an
> 'official' test result as recognized by APHIS
> .
>
> Dr. Detwiler: That's on the slaughter. But on the clinical cases, aren't
> they still asking for the brain? But even on the slaughter, they're looking
> only at the brainstem. We may be missing certain things if we confine
> ourselves to one area.
>
>
> snip.............
>
>
> Dr. Detwiler: It seems a good idea, but I'm not aware of it.
> Another important thing to get across to the public is that the negatives
> do not guarantee absence of infectivity. The animal could be early in the
> disease and the incubation period. Even sample collection is so important.
> If you're not collecting the right area of the brain in sheep, or if
> collecting lymphoreticular tissue, and you don't get a good biopsy, you
> could miss the area with the PRP in it and come up with a negative test.
> There's a new, unusual form of Scrapie that's been detected in Norway. We
> have to be careful that we don't get so set in the way we do things that we
> forget to look for different emerging variations of disease. We've gotten
> away from collecting the whole brain in our systems. We're using the brain
> stem and we're looking in only one area. In Norway, they were doing a
> project and looking at cases of Scrapie, and they found this where they did
> not find lesions or PRP in the area of the obex. They found it in the
> cerebellum and the cerebrum. It's a good lesson for us. Ames had to go
> back and change the procedure for looking at Scrapie samples. In the USDA,
> we had routinely looked at all the sections of the brain, and then we got
> away from it. They've recently gone back.
>
> Dr. Keller: Tissues are routinely tested, based on which tissue provides an
> 'official' test result as recognized by APHIS
> .
>
> Dr. Detwiler: That's on the slaughter. But on the clinical cases, aren't
> they still asking for the brain? But even on the slaughter, they're looking
> only at the brainstem. We may be missing certain things if we confine
> ourselves to one area.
>
>
> snip...
>
>
> FULL TEXT;
>
>
> Completely Edited Version
> PRION ROUNDTABLE
>
>
> Accomplished this day, Wednesday, December 11, 2003, Denver, Colorado
>
>
> 2005
>
>
> National Veterinary Services Laboratory (NVSL) Immunohistochemistry (IHC)
> Testing Summary
>
> The BSE enhanced surveillance program involves the use of a rapid screening
> test, followed by confirmatory testing for any samples that come back
> "inconclusive." The weekly summary below captures all rapid tests conducted
> as part of the enhanced surveillance effort. It should be noted that since
> the enhanced surveillance program began, USDA has also conducted
> approximately 9,200 routine IHC tests on samples that did not first undergo
> rapid testing.
>
>
> http://www.aphis.usda.gov/lpa/issues/bse_testing/test_results.html
>
>
>
> Office of Inspector General OIG
>
> Semiannual Report to Congress FY - 2005 - First Half
>
> snip...
>
>
> Stopping BSE at the Border—USDA Needs To
>
> Strengthen Controls Over Canadian Beef Imports
>
> Following the detection of a Canadian cow with bovine
>
> spongiform encephalopathy (BSE or “mad cow disease”)
>
> in May 2003, we examined the Animal and Plant Health
>
> Inspection Service’s (APHIS) oversight of the importation
>
> of beef products from Canada. Following requests from
>
> four U.S. Senators, we began several reviews in June
>
> 2004 to explore whether USDA did not follow appropriate
>
> safety measures, beginning sometime in the fall of 2003,
>
> in allowing expanded Canadian beef imports into the
>
> United States.
>
> After the initial halt of imports, in August 2003 the
>
> Secretary announced a list of low-risk products that would
>
> be allowed from Canada. APHIS also allowed an
>
> expansion in the type of Canadian facilities that could
>
> produce items for export to the United States. The
>
> gradual expansion occurred because agency employees
>
> included products similar to those on the published lowrisk
>
> list, but APHIS did not communicate this broadly.
>
> As a result, from August 2003 to April 2004, APHIS issued
>
> permits for products with questionable eligibility. Contrary
>
> to publicly stated policy, the agency allowed the import of
>
> products from Canadian facilities that produced both
>
> eligible and ineligible products, increasing the possibility
>
> that higher-risk product could be inadvertently imported.
>
> APHIS also issued permits to allow the import of more
>
> than 63,000 pounds of beef cheek meat with questionable
>
> eligibility because the agency did not establish a clear
>
> definition for “boneless beef.” Further, we found that
>
> FSIS did not always communicate effectively about the
>
> eligibility status of beef cheek meat, specifically to import
>
> inspectors. In addition, APHIS issued 1,155 permits for
>
> the importation of ruminant (e.g., cow, goat) products
>
> from Canada without ensuring that the agency had an
>
> appropriate system of internal controls to manage the
>
> process for a suddenly overwhelming volume of requests.
>
> From May through September 2004, we identified more
>
> than 42,000 pounds of product with questionable
>
> eligibility.
>
> APHIS generally agreed to institute procedures for
>
> communicating changes in policy and monitoring the
>
> consistency between agency practice and publicly stated
>
> policy, as well as to strengthen controls and finalize
>
> procedures to issue and monitor permits. FSIS generally
>
> agreed to implement controls to communicate the specific
>
> eligibility of product when its eligibility status changes and
>
> to implement an edit check in its import information
>
> system to identify ineligible product. (Audit Report No.
>
> 33601-1-Hy, APHIS Oversight of the Importation of Beef
>
> Products from Canada)
>
>
> snip...
>
>
> Restaurant Owner Sentenced for Smuggling Beef
>
> from Japan, Importation of Which Is Prohibited Due
>
> to Disease Concerns
>
> In January 2005, a Los Angeles restaurant owner was
>
> placed on probation for 60 months, to include 800 hours
>
> of community service, after he pled guilty to smuggling
>
> beef from Japan. Under 9 Code of Federal Regulations
>
> (C.F.R.) § 94, beef from Japan is a prohibited product
>
> for United States importation due to disease. On two
>
> occasions in 2001 and 2002, inspectors in Anchorage,
>
> Alaska, intercepted shipments sent from Japan that
>
> were manifested as “book,” but upon inspection by
>
> USDA and the United States Customs Service, were
>
> found to contain approximately 25 kilograms of beef
>
> inside a Styrofoam ice chest. Both shipments were
>
> addressed to the restaurant owner. Shipping records
>
> showed that the restaurant owner had received 13
>
> shipments manifested as “book” from the same sender
>
> in Japan in 2001 and 2002. All but one of the shipments
>
> were in the same weight range as the two intercepted
>
> shipments. The shipper and the restaurant owner were
>
> subsequently indicted for various charges including
>
> conspiracy and smuggling. An arrest warrant was
>
> issued for the shipper, who is still in Japan.
>
>
> http://www.usda.gov/oig/webdocs/SarcFirstHalf05.pdf
>
>
> GAO-06-157R FDA Feed Testing Program
>
> October 11, 2005
>
>
> SNIP...FULL TEXT 29 PAGES ;
>
>
> http://www.gao.gov/new.items/d06157r.pdf
>
>
> Mad Cow Disease: An Evaluation of a Small Feed Testing Program FDA
> Implemented in 2003 With Recommendations for Making the Program a Better
> Oversight Tool. GAO-06-157R, October 11
>
> http://www.gao.gov/cgi-bin/getrpt?GAO-06-157R
>
>
> CVM Update
> November 2005 Update on Feed Enforcement Activities to Limit the Spread of
> BSE
>
> To help prevent the establishment and amplification of BSE through feed in
> the United States, FDA implemented a final rule that prohibits the use of
> most mammalian protein in feeds for ruminant animals. This rule, Title 21
> Part 589.2000 of the Code of Federal Regulations, here called the Ruminant
> Feed Ban, became effective on August 4, 1997.
>
> This is an update on FDA enforcement activities regarding the ruminant feed
> regulation. FDA's CVM has assembled data from the inspections that have been
> conducted AND whose final inspection report has been recorded in the FDA's
> inspection database as of November 26, 2005. As of November 26, 2005, FDA
> had received over 41,000 inspection reports. The majority of these
> inspections (around 68%) were conducted by State officials under contract to
> FDA, with the remainder conducted by FDA officials.
>
> Inspections conducted by FDA or State investigators are classified to
> reflect the compliance status at the time of the inspection based upon the
> objectionable conditions documented. These inspection conclusions are
> reported as Official Action Indicated (OAI), Voluntary Action Indicated
> (VAI), or No Action Indicated (NAI).
>
> An OAI inspection classification occurs when significant objectionable
> conditions or practices were found and regulatory sanctions are warranted in
> order to address the establishment's lack of compliance with the regulation.
> An example of an OAI inspection classification would be findings of
> manufacturing procedures insufficient to ensure that ruminant feed is not
> contaminated with prohibited material. Inspections classified with OAI
> violations will be promptly re-inspected following the regulatory sanctions
> to determine whether adequate corrective actions have been implemented.
>
> A VAI inspection classification occurs when objectionable conditions or
> practices were found that do not meet the threshold of regulatory
> significance, but do warrant advisory actions to inform the establishment of
> findings that should be voluntarily corrected. Inspections classified with
> VAI violations are more technical violations of the Ruminant Feed Ban. These
> include provisions such as minor recordkeeping lapses and conditions
> involving non-ruminant feeds.
>
> An NAI inspection classification occurs when no objectionable conditions or
> practices were found during the inspection or the significance of the
> documented objectionable conditions found does not justify further actions.
>
> The results to date are reported here both by ?segment of industry? and ?in
> total?. NOTE ? A single firm can operate as more than one firm type. As a
> result, the categories of the different industry segments are not mutually
> exclusive.
>
> RENDERERS
>
> These firms are the first to handle and process (i.e., render) animal
> proteins and to send these processed materials to feed mills and/or protein
> blenders for use as a feed ingredient.
>
> Number of active firms whose initial inspection has been reported to FDA ?
> 274
>
> Number of active firms handling materials prohibited from use in ruminant
> feed ? 185 (68% of those active firms inspected)
>
> Of the 185 active firms handling prohibited materials, their most recent
> inspection revealed that:
>
> 1 firm (0.5%) was classified as OAI
>
> 11 firms (5.9%) were classified as VAI
>
> LICENSED FEED MILLS
>
> FDA licenses these feed mills to produce medicated feed products. The
> license is required to manufacture and distribute feed using certain potent
> drug products, usually those requiring some pre-slaughter withdrawal time.
> This licensing has nothing to do with handling prohibited materials under
> the feed ban regulation. A medicated feed license from FDA is not required
> to handle materials prohibited under the Ruminant Feed Ban.
>
> Number of active firms whose initial inspection has been reported to FDA ?
> 1,079
>
> Number of active firms handling materials prohibited from use in ruminant
> feed ? 426 (39% of those active firms inspected)
>
> Of the 426 active firms handling prohibited materials, their most recent
> inspection revealed that:
>
> 0 firm (0%) was classified as OAI
>
> 8 firms (1.9%) were classified as VAI
>
> FEED MILLS NOT LICENSED BY FDA
>
> These feed mills are not licensed by the FDA to produce medicated feeds.
>
> Number of active firms whose initial inspection has been reported to FDA ?
> 5,165
>
> Number of active firms handling materials prohibited from use in ruminant
> feed ? 2,036 (39% of those active firms inspected)
>
> Of the 2,036 active firms handling prohibited materials, their most recent
> inspection revealed that:
>
> 2 firms (0.1%) were classified as OAI
>
> 24 firms (1.2%) were classified as VAI
>
> PROTEIN BLENDERS
>
> These firms blend rendered animal protein for the purpose of producing
> quality feed ingredients that will be used by feed mills.
>
> Number of active firms whose initial inspection has been reported to FDA --
> 340
>
> Number of active firms handling materials prohibited from use in ruminant
> feed ? 147 (43% of those active firms inspected)
>
> Of the 147 active firms handling prohibited materials, their most recent
> inspection revealed that:
>
> 0 firms (0%) were classified as OAI
>
> 7 firms (4.8%) were classified as VAI
>
> RENDERERS, FEED MILLS, AND PROTEIN BLENDERS
>
> This category includes only those firms that actually use prohibited
> material to manufacture, process, or blend animal feed or feed ingredients.
>
> Number of active renderers, feed mills, and protein blenders whose initial
> inspection has been reported to FDA ? 6,576
>
> Number of active renderers, feed mills, and protein blenders processing with
> prohibited materials ? 539 (8.2% of those active firms inspected)
>
> Of the 539 of active renderers, feed mills, and protein blenders processing
> with prohibited materials, their most recent inspection revealed that:
>
> 3 firms (0.6%) were classified as OAI
>
> 23 firms (4.3%) were classified as VAI
>
> OTHER FIRMS INSPECTED
>
> Examples of such firms include ruminant feeders, on-farm mixers, pet food
> manufacturers, animal feed salvagers, distributors, retailers, and animal
> feed transporters.
>
> Number of active firms whose initial inspection has been reported to FDA ?
> 13,477
>
> Number of active firms handling materials prohibited from use in ruminant
> feed ? 3,748 (28% of those active firms inspected)
>
> Of the 3,748 active firms handling prohibited materials, their most recent
> inspection revealed that:
>
> 8 firms (0.2%) were classified as OAI
>
> 95 firms (2.5%) were classified as VAI
>
> TOTAL FIRMS
>
> Note that a single firm can be reported under more than one firm category;
> therefore, the summation of the individual OAI/VAI firm categories will be
> more than the actual total number of OAI/VAI firms, as presented below.
>
> Number of active firms whose initial inspection has been reported to FDA ?
> 16,476
>
> Number of active firms handling materials prohibited from use in ruminant
> feed ? 4,553 (27% of those active firms inspected)
>
> Of the 4,553 active firms handling prohibited materials, their most recent
> inspection revealed that:
>
> 9 firms (0.2%) were classified as OAI
>
> 107 firms (2.4%) were classified as VAI
>
>
> ----------------------------------------------------------------------------
> ----
>
> Issued by:
> FDA, Center for Veterinary Medicine,
> Communications Staff, HFV-12
> 7519 Standish Place, Rockville, MD 20855
> Telephone: (240) 276-9300 FAX: (240) 276-9115
> Internet Web Site: http://www.fda.gov/cvm
>
>
> http://www.fda.gov/cvm/5580.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. [flounder9@verizon.net]
>
> Sent: Thursday, September 08, 2005 6:17 PM
>
> To: fsis.regulationscomments@fsis.usda.gov
>
> 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 ;
>
> snip...FULL TEXT ;
>
>
> http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf
>
>
> Importation of Whole Cuts of Boneless Beef from Japan [Docket No. 05-004-1]
> RIN 0579-AB93 TSS SUBMISSION
>
>
> http://docket.epa.gov/edkfed/do/EDKStaffItemDetailView?objectId=090007d48099
> 3808
>
>
> http://docket.epa.gov/edkfed/do/EDKStaffAttachDownloadPDF?objectId=090007d48
> 0993808
>
>
> http://docket.epa.gov/edkfed/do/EDKStaffCollectionDetailView?objectId=0b0007
> d48096b40d
>
>
> ========================================================
>
> ========================================================
>
> OLD TSS SUBMISSIONS;
>
>
> Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW BSE
> SAFEGUARDS (comment submission)
>
> https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08
> d?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?O
> penDocument&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
>
>
> PDF]Freas, William TSS SUBMISSION
>
> File Format: PDF/Adobe Acrobat -
>
> Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary
>
> Sr. [flounder@wt.net] Monday, January 08,200l 3:03 PM freas ...
>
>
> http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf
>
>
> 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
>
> TSS
>
> #################### https://lists.aegee.org/bse-l.html
> ####################
>
> #################### https://lists.aegee.org/bse-l.html ####################
>



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