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From: TSS ()
Subject: RE---THE VOCAL POINT: Texas tour finds beef industry in fine form (NOT)
Date: April 8, 2005 at 1:48 pm PST

http://web.meatingplace.com/news/init.asp?s=13d982005_14075

-------- Original Message --------
Subject: RE---THE VOCAL POINT: Texas tour finds beef industry in fine form
Date: Fri, 08 Apr 2005 10:48:18 -0500
From: "Terry S. Singeltary Sr."
To: dmurphy@meatingplace.com
CC: phisey@meatingplace.com


> Despite media misinformation on BSE, despite the mudslinging from
> activists on beef safety,


SO SOON do they forget. when will they learn that denial
will not get them anywhere. NO misinformation here, just
the truth...


I had acquired the transcript of the Oprah trial yeas ago,
I still have the news clippings about this, my favorite part ;


CHIP -

exhibit 280, ... According to this US Department of Agriculture report,
encephalitis caused by unknown reasons could be a warning sign for
bovine spongiform encephalopathy, or mad cow disease. Is that your
understanding?

MIKE - Well, that's one of the things they told us to look for.

CHIP - Yeah, that's my point. Now, would you pull out Exhibit 358,
please. Could you tell us what those documents are?

MIKE - Those are dead slips from Cactus Feeders.

CHIP - Your fathers company.

MIKE ENGLER - Yes.

CHIP - and these show that the cause of death was encephalitis, correct?

Mike studies Exhibit 358.

MIKE ENGLER

Encephalitis, yes.

CHIP

And that was one of the neurological diseases that we just saw the
United States Department of Agriculture was saying was a possible cause

MIKE - Correct.

CHIP - There's something else stamped on here.
It says ''picked up by your local used cow dealer''.
Do you see that?

MIKE - Yes

CHIP - And that stamp means that these cows had died of encephalitis
before being taken to the rendering plant where they were ground
up, or rendered, in to feed for other cattle, correct?

MIKE - That's a possibility. .....snip....end
==============================


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.

####

rule

http://www.fda.gov/bbs/topics/news/2004/NEW01061.html

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.

snip...

http://www.fda.gov/bbs/topics/NEWS/2001/NEW00752.html

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)

* 167 kB Report


* 105 kB 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 90s 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

USA BSE GBR RAISED TO BSE GBR III


Working Group Report on the Assessment of the Geographical BSE-Risk (GBR

III) of USA 2004 ''extremely/very unstable BSE/cattle system''

USA

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/574/sr03_biohaz02_usa_report_annex_en1.pdf>


CANADA

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


MEXICO

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/566/sr04_biohaz02_mexico_report_annex_en1.pdf


Canada and the United States have been raised to level III (presence of BSE
likely but not confirmed, or confirmed at a lower level) following a new
assessment taking into account the most recent evidence. EFSAs Scientific
Expert Working Group on geographic BSE risk assessment also evaluated the
status of Mexico and South Africa which were classified as level III.


http://www.efsa.eu.int/press_room/press_release/575_en.html


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

What GAO Found

United States Government Accountability Office

Why GAO Did This Study

Highlights

Accountability Integrity Reliability

www.gao.gov/cgi-bin/getrpt?GAO-05-101.

To view the full product, including the scope

and methodology, click on the link above.

For more information, contact Robert A.

Robinson at (202) 512-3841 or

robinsonr@gao.gov.

Highlights of GAO-05-101, a report to

congressional requesters

February 2005

MAD COW DISEASE

FDAs Management of the Feed Ban Has

Improved, but Oversight Weaknesses

Continue to Limit Program Effectiveness

FDA has made needed improvements to its management and oversight of the

feed-ban rule in response to GAOs 2002 report, but program weaknesses

continue to limit the effectiveness of the ban and place U.S. cattle at
risk of

spreading BSE. Improvements made include FDA establishing a uniform

method of conducting compliance inspections and training FDA inspectors,

as well as state inspectors who carry out inspections under agreements with

FDA, on the new method. FDA also implemented new data-entry procedures

that are designed to more reliably track feed-ban inspection results.

Consequently, FDA has a better management tool for overseeing compliance

with the feed-ban rule and a data system that better conforms to standard

database management practices. However, various program weaknesses

continue to undermine the nations firewall against BSE. For example:

" FDA acknowledges that there are more feed manufacturers and

transporters, on-farm mixers, and other feed industry businesses that are

subject to the feed ban than the approximately 14,800 firms inspected to

date; however, it has no uniform approach for identifying additional

firms.

" FDA has not reinspected approximately 2,800, or about 19 percent, of

those businesses, in 5 or more years; several hundred are potentially

high risk. FDA does not know whether those businesses now use

prohibited material in their feed.

" FDAs feed-ban inspection guidance does not include instructions to

routinely sample cattle feed to test for potentially prohibited material as

part of the compliance inspection. Instead, it includes guidance for

inspectors to visually examine facilities and equipment and review

invoices and other documents.

" Feed intended for export is not required to carry a caution label Do not

feed to cattle or other ruminants, when the label would be required if

the feed were sold domestically. Without that statement, feed containing

prohibited material could be inadvertently or intentionally diverted back

to U.S. cattle or given to foreign cattle.

" FDA has not always alerted USDA and states when it learned that cattle

may have been given feed that contained prohibited material. This lapse

has been occurring even though FDAs guidance calls for such

communication.

" Although research suggests that cattle can get BSE from ingesting even a

small amount of infected material, inspectors do not routinely inspect or

review cleanout procedures for vehicles used to haul cattle feed.

More than 5 million cattle across

Europe have been killed to stop the

spread of bovine spongiform

encephalopathy (BSE), commonly

called mad cow disease. Found in

26 countries, including Canada and

the United States, BSE is believed

to spread through animal feed that

contains protein from BSE-infected

animals. Consuming meat from

infected cattle has also been linked

to the deaths of about 150 people

worldwide. In 1997, the Food and

Drug Administration (FDA) issued

a feed-ban rule prohibiting certain

animal protein (prohibited

material) in feed for cattle and

other ruminant animals. FDA and

38 states inspect firms in the feed

industry to enforce this critical

firewall against BSE. In 2002, GAO

reported a number of weaknesses

in FDAs enforcement of the feed

ban and recommended corrective

actions. This report looks at FDAs

efforts since 2002 to ensure

industry compliance with the feed

ban and protect U.S. cattle.

What GAO Recommends

GAO recommends FDA, among

other things, develop procedures

for finding additional firms subject

to the feed-ban and using tests to

augment inspections. FDA said the

study was thorough but disagreed

on four of nine recommendations.

GAO continues to believe that,

given the discovery of BSE in North

America and the oversight gaps

described in the report, the

recommended actions are needed

to protect U.S. cattle from BSE.

3. Mad Cow Disease: FDA's Management of the Feed Ban Has Improved,

but Oversight Weaknesses Continue to Limit Program Effectiveness.

GAO-05-101, Feb. 25.

http://www.gao.gov/cgi-bin/getrpt?GAO-05-101

Highlights - http://www.gao.gov/highlights/d05101high.pdf

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

Terry S. Singeltary Sr. P.O. BOX 42 Bacliff, TEXAS USA


Gerald Wells: Report of the Visit to USA, April-May 1989

snip...

The general opinion of those present was that BSE, as an
overt disease phenomenon, _could exist in the USA, but if it did,
it was very rare. The need for improved and specific surveillance
methods to detect it as recognised...

snip...

It is clear that USDA have little information and _no_ regulatory
responsibility for rendering plants in the US...

snip...

3. Prof. A. Robertson gave a brief account of BSE. The US approach
was to accord it a _very low profile indeed_. Dr. A Thiermann showed
the picture in the ''Independent'' with cattle being incinerated and
thought
this was a fanatical incident to be _avoided_ in the US _at all costs_...

snip...

http://www.bseinquiry.gov.uk/files/mb/m11b/tab01.pdf

To be published in the Proceedings of the
Fourth International Scientific Congress in
Fur Animal Production. Toronto, Canada,
August 21-28, 1988

Evidence That Transmissible Mink Encephalopathy
Results from Feeding Infected Cattle

R.F. Marsh* and G.R. Hartsough

"Department of Veterinary Science, University of Wisconsin-Madison,
Madison,
Wisconsin 53706; and ^Emba/Creat Lakes Ranch Service, Thiensville,
Wisconsin 53092

ABSTRACT
Epidemiologic investigation of a new incidence of
transmissible mink encephalopathy (TME) in Stetsonville, Wisconsin
suggests that the disease may have resulted from feeding infected
cattle to mink. This observation is supported by the transmission of
a TME-like disease to experimentally inoculated cattle, and by the
recent report of a new bovine spongiform encephalopathy in
England.

INTRODUCTION

Transmissible mink encephalopathy (TME) was first reported in 1965 by
Hartsough
and Burger who demonstrated that the disease was transmissible with a
long incubation
period, and that affected mink had a spongiform encephalopathy similar
to that found in
scrapie-affecied sheep (Hartsough and Burger, 1965; Burger and
Hartsough, 1965).
Because of the similarity between TME and scrapie, and the subsequent
finding that the
two transmissible agents were indistinguishable (Marsh and Hanson,
1969), it was
concluded that TME most likely resulted from feeding mink
scrapie-infecied sheep.
The experimental transmission of sheep scrapie to mink (Hanson et al.,
1971)
confirmed the close association of TME and scrapie, but at the same time
provided
evidence that they may be different. Epidemiologic studies on previous
incidences of
TME indicated that the incubation periods in field cases were between
six months and
one year in length (Harxsough and Burger, 1965). Experimentally, scrapie
could not be
transmitted to mink in less than one year.
To investigate the possibility that TME may be caused by a (particular
strain of
scrapie which might be highly pathogenic for mink, 21 different strains
of the scrapie
agent, including their sheep or goat sources, were inoculated into a
total of 61 mink.
Only one mink developed a progressive neurologic disease after an
incubation period of
22 mon..s (Marsh and Hanson, 1979). These results indicated that TME was
either caused
by a strain of sheep scrapie not yet tested, or was due to exposure to a
scrapie-like agent
from an unidentified source.

OBSERVATIONS AND RESULTS

A New Incidence of TME. In April of 1985, a mink rancher in
Stetsonville, Wisconsin
reported that many of his mink were "acting funny", and some had died.
At this time, we
visited the farm and found that approximately 10% of all adult mink were
showing
typical signs of TME: insidious onset characterized by subtle behavioral
changes, loss of
normal habits of cleanliness, deposition of droppings throughout the pen
rather than in a
single area, hyperexcitability, difficulty in chewing and swallowing,
and tails arched over
their _backs like squirrels. These signs were followed by progressive
deterioration of
neurologic function beginning with locomoior incoordination, long
periods of somnolence
in which the affected mink would stand motionless with its head in the
corner of the
cage, complete debilitation, and death. Over the next 8-10 weeks,
approximately 40% of
all the adult mink on the farm died from TME.
Since previous incidences of TME were associated with common or shared
feeding
practices, we obtained a careful history of feed ingredients used over
the past 12-18
months. The rancher was a "dead stock" feeder using mostly (>95%) downer
or dead dairy
cattle and a few horses. Sheep had never been fed.

Experimental Transmission. The clinical diagnosis of TME was confirmed by
histopaihologic examination and by experimental transmission to mink
after incubation
periods of four months. To investigate the possible involvement of
cattle in this disease
cycle, two six-week old castrated Holstein bull calves were inoculated
intracerebrally
with a brain suspension from affected mink. Each developed a fatal
spongiform
encephalopathy after incubation periods of 18 and 19 months.

DISCUSSION
These findings suggest that TME may result from feeding mink infected
cattle and
we have alerted bovine practitioners that there may exist an as yet
unrecognized
scrapie-like disease of cattle in the United States (Marsh and
Hartsough, 1986). A new
bovine spongiform encephalopathy has recently been reported in England
(Wells et al.,
1987), and investigators are presently studying its transmissibility and
possible
relationship to scrapie. Because this new bovine disease in England is
characterized by
behavioral changes, hyperexcitability, and agressiveness, it is very
likely it would be
confused with rabies in the United Stales and not be diagnosed.
Presently, brains from
cattle in the United States which are suspected of rabies infection are
only tested with
anti-rabies virus antibody and are not examined histopathologically for
lesions of
spongiform encephalopathy.
We are presently pursuing additional studies to further examine the
possible
involvement of cattle in the epidemiology of TME. One of these is the
backpassage of
our experimental bovine encephalopathy to mink. Because (here are as yet
no agent-
specific proteins or nucleic acids identified for these transmissible
neuropathogens, one
means of distinguishing them is by animal passage and selection of the
biotype which
grows best in a particular host. This procedure has been used to
separate hamster-
adapted and mink-udapted TME agents (Marsh and Hanson, 1979). The
intracerebral
backpassage of the experimental bovine agent resulted in incubations of
only four months
indicating no de-adaptation of the Stetsonville agent for mink after
bovine passage.
Mink fed infected bovine brain remain normal after six months. It will
be essential to
demonstrate oral transmission fiom bovine to mink it this proposed
epidemiologic
association is to be confirmed.

ACKNOWLEDGEMENTS
These studies were supported by the College of Agricultural and Life
Sciences,
University of Wisconsin-Madison and by a grant (85-CRCR-1-1812) from the
United
States Department of Agriculture. The authors also wish to acknowledge
the help and
encouragement of Robert Hanson who died during the course of these
investigations.

REFERENCES
Burger, D. and Hartsough, G.R. 1965. Encephalopathy of mink. II.
Experimental and
natural transmission. J. Infec. Dis. 115:393-399.
Hanson, R.P., Eckroade, R.3., Marsh, R.F., ZuRhein, C.M., Kanitz, C.L.
and Gustatson,
D.P. 1971. Susceptibility of mink to sheep scrapie. Science 172:859-861.
Hansough, G.R. and Burger, D. 1965. Encephalopathy of mink. I.
Epizoociologic and
clinical observations. 3. Infec. Dis. 115:387-392.
Marsh, R.F. and Hanson, R.P. 1969. Physical and chemical properties of the
transmissible mink encephalopathy agent. 3. ViroL 3:176-180.
Marsh, R.F. and Hanson, R.P. 1979. On the origin of transmissible mink
encephalopathy. In Hadlow, W.J. and Prusiner, S.P. (eds.) Slow
transmissible
diseases of the nervous system. Vol. 1, Academic Press, New York, pp
451-460.
Marsh, R.F. and Hartsough, G.R. 1986. Is there a scrapie-like disease in
cattle?
Proceedings of the Seventh Annual Western Conference for Food Animal
Veterinary
Medicine. University of Arizona, pp 20.
Wells, G.A.H., Scott, A.C., Johnson, C.T., Cunning, R.F., Hancock, R.D.,
Jeffrey, M.,
Dawson, M. and Bradley, R. 1987. A novel progressive spongiform
encephalopathy
in cattle. Vet. Rec. 121:419-420.

MARSH

http://www.bseinquiry.gov.uk/files/mb/m09/tab05.pdf


> Now, there is no denying that critics have made animal health
> products, such as hormones and antibiotics, the focal point of their
> attacks on the safety and wholesomeness of meat and poultry products.
> Concurrent with these campaigns has been a rise in interest  if not
> tonnage  of so-called "natural" and antibiotic-free meat products.


MRSA is a new super bug, not a
TSE. Nov. 2001 I go for my 3rd neck surgery. gonna fuse
my complete spine with my hip again and put a titanium plate
with 6 screws. I refused cadaver bone and blood for fear
of CJD and of the flip side, MY neurosurgeon had to use some
disposable tools and a bone grinder that would not be used
on the public again, due to the hcCJD my Mom died from,
I was a risk factor. Well, they damn near kill me with MRSA,
a hospital infection caused, in my opinion, by the mass amounts
of antibiotics and hormones cattle are being pumped up with,
due to the simple fact they are too sick to go to slaughter.
THUS, humans are becoming more resistant to them and
maybe why such young girls are maturing at such a young age.

HAVE you ever read some of the warning letters for this???

6 weeks vancomycin straight to heart
via long line (PIC). damn near killed me and about halfway through,
the vancomycin stopped working and they had to up the dose. while
searching for mad cow feed ban warning letters (in which the Bush
administration made secret, and would not grant my request through
the FOIA to get them), low and behold, i find all these warning letters
for cattle that are pumped with massive amounts of antibiotics and
hormones due to the fact the animals are so sick when the go to slaugher,
they must do this in order for the animal to make it there on it's on feet.
and then they wonder why humans are becoming resistant to them and why
young girls are maturing so fast. DAaaaaaaaa. this is just warning
letters for
this week;


Department of Health and Human Services

Public Health Service
Food and Drug Administration

San Francisco District
1431 Harbor Bay Parkway
Alameda. CA 94502-7070
Telephone: 510/337-6700


VIA FEDERAL EXPRESS
Our Reference: 1000135249

February 11, 2004

Ronald Hilarides, Managing Partner
Peter Schaafsma, Partner
S & H Dairy
4125 Bentley Road
Oakdale, California 95361-7935

WARNING LETTER

Dear Mssrs. Hilarides and Schaafsma:

An investigation of your dairy operation in Oakdale, California
conducted by Food and Drug Administration (FDA) investigators on
December 9 and 12, 2003, confirmed that you offered an animal for sale
for slaughter as food in violation of Sections 402(a)(2)(C)(ii) and
402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21
U.S.C. 342(a)(2)(C)(ii) and 342(a)(4). You also caused animal drugs to
become adulterated within the meaning of Section 501 (a)(5) of the Act,
21 U.S.C. 351, because the drugs were used in a manner that does not
conform with their approved use or the extralabel use regulations at
Title 21, Code of Federal Regulations, Part 530 (21 C.F.R. 530).

On or about October 9, 2003, you consigned a cow identified by United
States Department of Agriculture (USDA) laboratory report number 434889
to be slaughtered for human food to [redacted] USDA analysis of tissue
samples collected from that animal identified the presence of neomycin
at 18.85 parts per million (ppm) in the kidney. A tolerance of 7.2 ppm
has been established for residues of neomycin in cattle kidney at 21
C.F.R. 556.430. The presence of neomycin above established tolerance
levels in the edible tissues from this animal causes the food to be
adulterated within the meaning of Section 402(a)(2)(C)(ii) of the Act.

A food is adulterated under Section 402(a)(4) of the Act if it has been
prepared, packed, or held under insanitary conditions whereby it may
have been rendered injurious to health. As it applies in this case,
insanitary conditions means that you hold animals which are ultimately
offered for sale for slaughter as food under conditions whereby
medicated animals bearing possibly harmful drug residues could enter the
food supply. For example, our investigator observed the following:

1. Your firm fails to maintain a complete, written medication
treatment record system for your animals that includes all
treatments, the date of treatment, the amount of each drug
administered, the route of administration, and the person who
administered each drug;

2. Your firm fails to follow labeled directions for the following drugs:

a. [redacted]
The labeled directions specify that milk from treated cows must
not be used for food during the first 72 hours after calving.
However, FDA learned that you routinely allow newborn bull
calves, destined for slaughter, to suckle from dams that have
been treated with the [redacted] before the 72-hour withdrawal
period specified on the label.

b. [redacted]
The labeled directions state that no more than 10 mL [redacted]
should be injected at any one site in adult livestock. However,
you administer 30 mL [redacted] mixed with sterile water and
infuse this into the uterus of dairy cows with retained placenta.

3. Your firm fails to maintain a drug inventory/accountability system.

You adulterated animal drugs within the meaning of Section 501(a)(5) of
the Act when you failed to use the drugs in conformance with their
approved conditions or use or the extralabel use regulations at 21
C.F.R. 530. Extralabel use of animal drugs is permitted only on the
lawful order of a licensed veterinarian within the context of a valid
veterinarian-client-patient relationship and in compliance with the
criteria set forth at 21 C.F.R. 530. Because your use of the drugs
[redacted], [redacted], and [redacted] on your cattle did not conform
with the drugs' approved labeling or the extralabel use regulations, the
drugs are unsafe under Section 512(a) of the Act. As a result, your use
of these drugs caused them to be adulterated within the meaning of
Section 501(a)(5) of the Act.

The above is not intended to be an all-inclusive list of violations. As
a producer of animals offered for use as food, you are responsible for
assuring that your overall operations and the food you distribute are in
compliance with the laws.

It is not necessary for you to personally ship an adulterated animal in
interstate commerce to be responsible for a violation of the Act. The
fact that you caused the adulteration of an animal that was sold and
subsequently offered for sale to a slaughterhouse that ships in
interstate commerce is sufficient to hold you responsible for a
violation of the Act.

You should take prompt action to correct the above violations and to
establish procedures whereby such violations do not occur. Failure to do
so may result in regulatory action, such as a seizure and/or injunction,
without further notice.

You should notify this office in writing within 15 working days of
receipt of this letter of the steps you have taken to bring your dairy
into compliance with the law. Your response should include each step
being taken, that has been taken, or that will be taken to correct the
violations and prevent their recurrence. If corrective action cannot be
completed within 15 working days, state the reason for the delay and the
time frame within which the corrections will be completed. Please
include copies of any available documentation demonstrating that
corrections have been made.

Your response should be directed to: Ms. Harumi Kishida, Compliance
Officer, U.S. Food and Drug Administration, 1431 Harbor Bay Parkway,
Alameda, CA 94502-7070. If you have any questions regarding any issue in
this letter, please contact Ms. Kishida at (510) 337-6824.

Sincerely,

/s/

Roderick V. Asmundson for
Charles M. Breen
Acting District Director
San Francisco District

horizonal rule

http://www.fda.gov/foi/warning_letters/g4553d.htm


Department of Health and Human Services

Public Health Service
Food and Drug Administration

Los Angeles District
19701 Fairchild
Irvine, California 92612-2506
Telephone (949) 608-2900


WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

February 9, 2004
W/L: 29-04

Phil Bauer
President
Phillips Cattle Company
345 N. Maple Dr., Ste. 296
Beverly Hills, CA 90210

Dear Mr. Bauer:

Our records reflect you are the president of Phillips Cattle Company
located at 910 Nichols Road, El Centro, CA. An investigation of your
feedlot operation conducted by our investigator on December 8 and 9,
2003, confirmed that you offered animals for sale for slaughter as food
which is in violation of Sections 402(a)(2)(C)(ii) and 402(a)(4) of the
Federal Food, Drug, and Cosmetic Act (henceforth the Act).

A food is adulterated under Section 402(a)(2)(C)(ii) of the Act if it
contains a new animal drug that is unsafe within the meaning of Section
512 of the Act. A food is further adulterated under Section 402(a)(4) of
the Act if it has been held under conditions whereby it may have been
rendered injurious to health.

On or about August 8, 2003, you sold a culled beef cow identified by
USDA Laboratory report 256547 for slaughter as human food. USDA analysis
of tissue samples collected from that animal identified the presence of
tilmicosin in the liver at 06.90 parts per million (ppm), in the muscle
at 0.94 ppm and in the kidney at 9.13 ppm. A tolerance of 1.20 ppm in
the liver and 0.10 ppm in the muscle has been established for residues
of tilmicosin in cattle. There is no tolerance for tilmicosin in the
kidney of cattle [21 CFR 556.735].

Our investigation also found that you hold animals under improper
conditions whereby diseased animals and/or medicated animals bearing
potentially harmful drug residues are likely to enter the food supply.
For example, you lack an adequate system for assuring that animals
medicated by you have been withheld from slaughter for the appropriate
periods of time to permit depletion of potentially hazardous residues of
drugs from edible tissues. Foods from animals held under such conditions
are considered adulterated under the Act.

It was further determined that you are using drugs in a manner contrary
to their approved labeling. Such extra-label use is not permitted,
except by or on the lawful written or oral order of a licensed
veterinarian within the context of a valid veterinarian-client-patient
relationship, and otherwise in compliance with the limitations set forth
for specific extra-label uses [21 CFR 530.10 and 530.11]. Your use of
drugs in any manner other than as labeled causes those drugs to bs:
adulterated under Section 501 (a)(5) of the Act because there is no
approval for such use as required by Section 512 (a)(1)(B) of the Act.

*

You are adulterating injectable tilmicon , such as [redacted] that
you use on cattle in a manner contrary to the approved labeling.
Injectable tilmicosin is labeled with a 28 day withdrawal time.
Culling an animal for slaughter 2 days after treatment with
tilmicosin does not conform to the approved labeling.

*

You are adulterating injectable penicillin, such as [redacted]
that you use on cattle in a manner contrary to the approved
labeling. The labeled instructions are 1 cc per 100 pounds of body
weight. Your use of 30 ccs per 800 pound animal does not conform
to the approved labeling.

The above is not intended to be an all-inclusive list of violations. As
a producer of animals, which are offered for use as food, you are
responsible for assuring that your overall operations and the food you
distribute are in compliance with the law.

Please note that it is not necessary for you to personally ship an
adulterated animal in interstate commerce to be responsible for a
violation of the Act. The fact that you caused the adulteration of an
animal that was sold to a slaughterhouse which ships in interstate
commerce is sufficient to hold you responsible for a violation of the Act.

Additionally, it is not necessary for you to have an illegal drug
residue in an animal to violate the law. We have reviewed your treatment
protocols as presented to our investigator and have the following
comments. All drugs are labeled with specific instructions on the dosage
and route of administration as well as the disease or condition to be
treated. Any deviation from the approved labeling is a violation of the
law. For example, your protocol indicates you are using [redacted]
without a withdrawal time. [redacted] is labeled with a 35 day
withdrawal time. Your shipment of any animal treated with [redacted]
prior to the 35 day withdrawal time is a violation of the law. Secondly,
your protocol indicates that you are using a 28 day withdrawal for
[redacted]. While this is the correct withdrawal time for intra-muscular
injection, when [redacted] is administered subcutaneous there is a 38
day withdrawal time. Also we note that your protocols identify both
[redacted]. These are two different forms of the drug and have different
dosages and withdrawal times. Your treatment records and protocols
should reflect this difference. Your protocol identifies a 2 day
withdrawal time for [redacted]. This is incorrect. [redacted] when used
as directed has a 4 day withdrawal time.

Review of the prescription forms presented to our investigator reveals
that [redacted] has identified a 28 day withdrawal for [redacted]
administered subcutaneously. The labeled withdrawal time as stated above
is 38 days. As stated above, extra-label use of new animal drugs is
authorized only when there is a valid veterinarian-client-patient
relationship. A valid veterinarian-client-patient relationship can exist
only where, among other requirements, a licensed and practicing
veterinarian has recently seen and is personally acquainted with the
keeping and care of the animals by virtue of examination of the
animal(s), and/or by medically appropriate and timely visits to the
premises where the animal(s) are kept. See 21 CFR 530.4(i). Our
investigator noted that [redacted] address is located in Texas and that
the prescription form appears to have originated from Texas. The
distance between [redacted] Texas address and the California lot where
the animals are kept raises questions about his ability and availability
to visit, care for, and examine the animals in the manner required by
the regulations. We recommend you evaluate your current veterinary
pactices.

Additionally, we strongly suggest you review your treatment protocols
with your veterinarian, university extension services or state animal
health officials to assure that you are using all medications in a legal
and effective manner.

You should take prompt action to correct the above violations and to
assure that the procedures you have established will prevent their
recurrence. Failure to do so may result in regulatory action, such as
injunction, without further notice. This letter constitutes official
notification under the law and provides you an opportunity to correct
the violations.

Please advise this office in writing within fifteen (15) working days of
receipt of this letter of the steps you have taken to bring your dairy
into compliance with the law. Your response should include each step
that has been taken to correct the violations and prevent their
recurrence. If corrective action cannot be completed within fifteen (15)
working days, state the reason for the delay and the time within which
such corrections will be made. If you have any questions or , need
clarifications regarding this letter prior to your written response, you
may contact Barbara Rincon, Compliance Officer at telephone number (949)
608-4439.

Your written response should be directed to:

Acting Director, Compliance Branch
U.S. Food and Drug Administration
19701 Fairchild
Irvine, CA 92612

Sincerely,

/s/ Alonza E. Cruse
District Director

cc: Ross Jenkins
General Manager
Phillips Cattle Co.
505 E. Barioni
Imperial, CA 92551

Lonnie Foster
Yard Manager
Phillips Cattle Co.
910 Nichols Rd.
El Centro, CA 92243

http://www.fda.gov/foi/warning_letters/g4554d.htm

a few more warning letters ;

NTIBIOTIC/HORMONE USE IN FARM ANIMALS

2. now what about those antibiotic and hormone use in cattle?
let us take a look at just this weeks warning letters, and
what about those 200,000 DOWNER CATTLE IN THE USA. how many
reach the consumers plate? well here is one that did;

On or about August 22, 2002, you sold a downer cow to [redacted] number
842 ET. This cow was subsequently identified on analysis of tissue
samples collected from this animal identified the presence of
Oxytetracycline at 8.47 ppm in the liver and 3.20 ppm in muscle tissue.
The maximum allowable tolerance for Oxytetracycline in cattle is 6 ppm
in the liver and 2 ppm in muscle tissue. In addition, Sulfadimethoxine
was found at 12.03 ppm in the liver and at 5.83 ppm in muscle tissue.
The maximum tolerance for Sulfadimethoxine in edible tissue of cattle is
0.1 ppm....

full text;

January 22, 2003
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 03-13

Jose L. Lourenco, Owner
Lourenco Dairy #2
19524 U.S. Highway 30
Buhl, Idaho 83316

WARNING LETTER

Dear Mr. Lourenco:

An investigation at your dairy located at 19524 U.S. Highway 30, Buhl,
Idaho, by our investigators on December 12, 2002 , confirmed that you
offered animals for sale for slaughter as food in violation of Section
402(a)(2)(C)(ii), and 402(a)(4) of the Federal Food, Drug, and Cosmetic
Act (the Act).

A food is adulterated under Section 402(a)(2)(C)(ii) of the Act if it
contains a new animal drug that is unsafe within the meaning of Section
512 of the Act. From July 22, 2002 to August 29, 2002, you sold cull
dairy cows for slaughter as human food to. Some of the cows had illegal
tissue residues asfollows:

1. On or about July 22, 2002, you sold a culled dairy cow to [redacted]
with no tag. The cow was subsequently tagged as carcass tag 659, and
identified on USDA form #433453. USDA analysis of tissue samples
collected from the cow identified the presence of Sulfadimethoxine at
2.12 parts per million (ppm) in the liver, and 1.52 ppm in muscle
tissue. The maximum allowable tolerance for Sulfadimethoxine in edible
tissue of cattle is .l ppm. In addition, this animal was found to
contain Tilmicosin at 16.90 ppm in the liver and 16.70 ppm in the
kidney. The maximum allowable tolerance for Tilmicosin in edible tissue
of cattle is 1.2 ppm.

2. On or about August 12, 2002, you sold a culled dairy cow with tag
number 1222 ET to [redacted]. This cow was subsequently identified on
USDA form # 433458. USDA analysis of tissue samples collected from this
animal identified the presence of Penicillin at .98 ppm in the kidney
and at .47 ppm in the liver. The maximum allowable tolerance for
Penicillin in edible tissue of cattle is 0.05 ppm.

3. On or about August 22, 2002, you sold a downer cow to [redacted]
number 842 ET. This cow was subsequently identified on analysis of
tissue samples collected from this animal identified the presence of
Oxytetracycline at 8.47 ppm in the liver and 3.20 ppm in muscle tissue.
The maximum allowable tolerance for Oxytetracycline in cattle is 6 ppm
in the liver and 2 ppm in muscle tissue. In addition, Sulfadimethoxine
was found at 12.03 ppm in the liver and at 5.83 ppm in muscle tissue.
The maximum tolerance for Sulfadimethoxine in edible tissue of cattle is
0.1 ppm.

4. On or about August 22, 2002, you sold a culled dairy cow to
[redacted] with ear tag number 718. This cow was subsequently identified
on USDA form 433459. USDA analysis of tissue samples collected from this
animal identified the presence of Penicillin at .84 ppm in the kidney.
The maximum tolerance for penicillin in edible tissue of cattle is 0.05
ppm. In addition, USDA found Sulfadimethoxine 6.41 ppm in the liver and
at 3.32 ppm in muscle tissue. The maximum allowable tolerance for
Sulfadimethoxine in edible tissue of cattle is 0.1 ppm.

5. On or about August 29, 2002, you sold a culled dairy cow to
[redacted] with no ear tag. The cow was subsequently identified with
carcass tag number 282, and identified on USDA form #433461. USDA
analysis of tissue samples collected from this animal identified the
presence of Penicillin at .77 ppm in the kidney and .38 in the liver.
The maximum tolerance for penicillin in edible tissue of cattle is 0.05
ppm.

A food is adulterated under Section 402(a)(4) of the Act "if it has been
prepared, packed, or held under insanitary conditions...~ hereby it may
have been rendered injurious to health." As it applies in this case,
"insanitary conditions" means that you hold animals which are ultimately
offered for sale for slaughter as food under conditions which are so
inadequate that medicated animals bearing possibly harmful drug residues
are likely to enter the food supply.

For example, our investigator noted the following conditions on your farm:

1. You failed to maintain medication records which identify the animal,
the date of medication, the drug, the dosage administered and the
pre-slaughter withdrawal time.

2. You failed to follow label directions for medications you
administered to your animals in that you failed to follow the labeled
pre-slaughter withdrawal times.

3. You failed to have a system of reviewing treatment records prior to
offering an animal for slaughter for human food, to assure that drugs
had been used only as directed and that the appropriate withdrawal times
had been observed.

4. You failed to have a valid veterinarian prescription for the use of
Penicillin in an Extra-label manor.

Our investigation revealed that the Penicillin residue came from your
use of Over the Counter Penicillin at dosages above the labeled amount
on your dairy herd. The use of Penicillin at amounts greater than that
stated on the label requires a valid prescription from a licensed
veterinarian. Your extra label use of Penicillin is a deviation from
Title 21, Code of Federal Regulations (21 CFR), Part 530, Extra label
Drug Use in Animals, which causes certain animal drugs used to medicate
food producing animals, to be adulterated within the meaning of Section
501(a)(5) of the Act, in that they are new animal drugs which are unsafe
within the meaning of Section 512(a)(4).

In October of 1994, Congress passed the Animal Medicinal Drug Use
Clarification Act, which permits extra-label use under certain
controlled conditions, specified in 21 CFR Part 530. Extra label use is
only permitted if the use is by or on the lawful order of a licensed
veterinarian within the context of a valid veterinarian/client/patient
relationship and in conformance with criteria set forth in Part 530.

We request that you take prompt action to ensure that dairy cows and
calves which you offer for sale as human food will not be adulterated
with drugs or contain illegal residues.

Introducing adulterated foods into interstate commerce is a violation of
Section 301(a) of the Act.

Causing the adulteration of drugs after receipt in interstate commerce
is a violation of Section 301(k) of the Act.

You should be aware that it is not necessary for you to have personally
shipped an adulterated animal into interstate commerce to be responsible
for a violation of the Act. The fact that you offered an adulterated
animal to be slaughtered into food for human consumption where it was
held for sale in interstate commerce is sufficient to make you
responsible for violations of the Act.

The above is not intended to be an all-inclusive list of violations. As
a producer of animals offered for use as food, you are responsible for
assuring that your overall operations and the foods you distribute are
in compliance with the law.

You should take prompt action to correct the above violations and to
establish procedures whereby such violations d o not recur. Failure to d
o so may result in regulatory action without further notice such as
seizure and/or injunction.

Within fifteen (15) days of the receipt of this letter, notify this
office in writing of the specific steps you have taken to correct these
violations and preclude their recurrence. If corrective action cannot be
complete d within fifteen working days, state the reason for the delay
and the time frame within which corrections will b e completed.

Please send your reply to the Food and Drug Administration, Attention:
Bruce Williamson, Compliance Officer, 22201 23rd Drive SE, Bothell, WA
98021. If you have questions regarding any issue in this letter, please
contact Bruce Williamson, Compliance Officer, at (425) 483-4976.

Sincerely,

/s/

Charles M. Breen

District Director

http://www.fda.gov/foi/warning_letters/g3808d.htm

WARNING LETTER

January 22, 2003
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
W/L# 18-03

Arthur H. Marquez
Owner
Marquez Dairy LLC
7360 Pine Ave.
Chino, CA 91710

Dear Mr. Marquez:

An investigation at your dairy operation located at 7360 Pine Avenue
Chino California, conducted by our investigators on November 13, 2002,
confirmed that you offered animals for sale for slaughter as food in
violation of Sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal
Food, Drug, and Cosmetic Act (henceforth the "Act").

A food is adulterated under Section 402(a)(2)(C)(ii) of the Act if it
contains a new animal drug that is unsafe within the meaning of Section
512 of the Act. A food is further adulterated under Section 402(a)(4) of
the Act if it has been held under conditions whereby it may have been
rendered injurious to health.

On or about August 5, 2002, you sold a culled dairy cow identified by
USDA Laboratory report 427797 for slaughter as human food. USDA analysis
of tissue samples collected from that animal identified the presence of
sulfadimethoxine in the muscle at 11.24 parts per million (ppm) and in
the liver at 14.80 ppm. A tolerance of 0.1 ppm has been established for
residues of sulfadimethoxine in the edible tissues of cattle. (Title 21,
Code of Federal Regulations, Section 556.640).

Our investigation also found that you hold animals under improper
conditions whereby diseased animals and/or medicated animals bearing
potentially harmful drug residues are likely to enter the food supply.
For example, you lack an adequate system for assuring that animals
medicated by you have been withheld from slaughter for the appropriate
periods of time to permit depletion of potentially hazardous residues of
drugs from edible tissues. Foods from animals held under such conditions
are considered adulterated under the Act.

Please note that it is not necessary for you to personally ship an
adulterated animal in interstate commerce to be responsible for a
violation of the Act. The fact that you caused the adulteration of an
animal that was sold to a slaughterhouse that ships in interstate
commerce is sufficient to hold you responsible for a violation of the Act.

The above is not intended to be an all-inclusive list of violations.
Government records available to us indicate there have been other
occasions when you have offered drug-adulterated animals for sale as
human food. As a producer of animals, which are offered for use as food,
you are responsible for assuring that your overall operations and the
food you distribute are in compliance with the law.

You should take prompt action to correct the above violations and to
assure that the procedures you have established will prevent their
recurrence. Failure to do so may result in regulatory action, such as
injunction, without further notice. This letter constitutes official
notification under the law and provides y ou an opportunity to correct.

Please advise this office in writing within fifteen (15) working days of
receipt of this letter of the steps you have taken to bring your dairy
into compliance with the law. Your response should include each step
that has been taken to correct the violations and prevent their
recurrence. If corrective action cannot be taken within fifteen (15)
working days, state the reason for the delay and the time within which
such corrections will be made. If you have any questions or need
clarifications regarding this letter prior to your written response, you
may contact Barbara Rincon, Compliance Officer at telephone number (949)
798-7739.

Your written response should be directed to:

Robert B. McNab

Acting Director, Compliance Branch

U.S. Food and Drug Administration

19900 MacArthur Blvd., Ste. 300

Irvine, CA 92612-2445

Sincerely,

/s/

Alonza E. Cruse

District Director

http://www.fda.gov/foi/warning_letters/g3807d.htm

January 13, 2003
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 03-11

Dale C. Devries, Owner
Thomas R. Devries, Owner
Devries Family Farm LLC
15720 Highway 24
Moxee, Washington 98936

WARNING LETTER

Dear Messrs. Devries:

An investigation at your dairy located at 15720 Highway 24, Moxee,
Washington, by our investigator on November 20-21, 2002, confirmed that
you offered animals for sale for slaughter as food in violation of
Section 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and
Cosmetic Act (the Act).

A food is adulterated under Section 402(a)(2)(C)(ii) of the Act if it
contains a new animal drug that is unsafe within the meaning of Section
5 12 of the Act.

On May 13, 2002, you delivered a holstein cow with back tag #91 TO 376
identified on USDA Case #01-1852-WA, Form #431002, to [redacted] sold
this holstein cow for slaughter as human food to [redacted] does not
medicate the animals. USDA analysis of tissue samples collected from
that animal identified the presence of sulfadimethoxine in the liver at
1.51 parts per million (ppm), and in the muscle at 1.84 ppm.

A tolerance of 0.1 ppm has been established for residues of
sulfadimethoxine in edible tissues of cattle (Title 21 Code of Federal
Regulations 556.640). This excess residue of sulfadimethoxine in edible
tissue from this animal causes the food to be adulterated.

A food is adulterated under Section 402(a)(4) of the Act "if it has been
prepared, packed, or held under insanitary conditions . . .whereby it
may have been rendered injurious to health." As it applies in this case,
"insanitary conditions" means that you hold animals which are ultimately
offered for sale for slaughter as food under conditions that are so
inadequate that medicated animals bearing potentially harmful drug
residues are likely to enter the food supply. For example, you lack an
adequate system for assuring that animals to which you administer
medication have been withheld from slaughter for appropriate periods of
time to deplete potentially hazardous residues of drugs from edible
tissues; you have no animal medication records that would identify which
animal had been medicated, what date the medication was administered,
what dosage of medication had been used, and what the withdrawal times
should be; and you lack an adequate system for ,assuring that drugs are
used in a manner not contrary to the directions contained in their
labeling.

It is not necessary for you to personally ship an adulterated animal in
interstate commerce to be responsible for a violation of the Act. The
fact that you caused the adulteration of an animal that was sold and
subsequently offered for sale to a slaughterhouse that ships in
interstate commerce is sufficient to hold you responsible for a
violation of the Act.

The above is not intended to be an all-inclusive list of violations. As
a producer of animals offered for use as food, you are responsible for
assuring that your overall operations and the foods you distribute are
in compliance with the law.

You should take prompt action to correct the above violations and to
establish procedures whereby such violations do not recur. Failure to do
so may result in regulatory action without further notice. These actions
may include, but are not limited to, seizure and/or injunction.

You should notify this office in writing, within fifteen (15) working
days of the receipt of this letter, of the specific steps you have taken
to bring your firm into compliance with the law. If corrective action
cannot be completed within 15 working days, state the reason for the
delay and the time frame within which the corrections will be completed.
Please include copies of any available documentation demonstrating that
corrections have been made.

Please send your reply to the Food and Drug Administration, Attention:
Lisa M. Elrand, Compliance Officer, 2220 1 23rd Drive SE, Bothell,
Washington 98021-4421. If you have questions regarding any issue in this
letter, please contact Lisa M. Elrand, Compliance Officer, at (425)
483-4913.

Sincerely,

/s/

Charles M. Breen

District Director

http://www.fda.gov/foi/warning_letters/g3803d.htm

December 15, 3003
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER

Ref. KAN 2003-04

Charles L. Vander Ploeg
President/CEO
Vet Pharm. Inc.
39215th Street N.E.
P.O. Box 167
Sioux Center, IA 51250

Dear Mr. Vander Ploeg:

Recently an inspection was made of your veterinary drug sales facility
located at the above address. This inspection was conducted from
September 11 to 13, 3002, by a Food and Drug Administration Investigator
from this office who documented sales of prescription drugs for
veterinary use that are adulterated within the meaning of Section
501(a)(5) of the Federal Food, Drug and Cosmetic Act (Act) and
misbranded within the meaning of Section 502(f)(1) of the Act.

The drugs "Amoxil Amoxicillin For Oral Suspension" and "Sulfamethoxazole
and Trimethoprim Oral Suspension USP" among others, are human drugs that
are being dispensed for animal use without the required Labeling.
including adequate directions for use.

Under Section 512(a)(5), a drug approved for human use may be used in
animals if its use or intended use is on the lawful order of a
veterinarian and is in compliance with the regulations at 21 CFR Part
530. The human drugs you are dispensing for use in animals are not in
compliance with 21 CFR 530.12 because they do not bear the required
labeling information.

Because your products do not comply with the applicable regulations.
they are unsafe within the meaning of Section 512(a) and are thus
adulterated under Section 501(a)(5).

In addition. prescription veterinary drugs intended for extralabel use
which you are dispensing are not in compliance with 21 CFR 520.12
because they do not bear the required labeling information. Because
these products do not comply with the applicable regulations, they are
also unsafe within the meaning of Section 512(a) and thus adulterated
under Section 501(a)(5).

Finally, because your products are dispensed without adequate directions
for use. they are misbranded under Section 502(f)(1).

You should take prompt action to correct these violations end to
establish procedures co prevent their recurrence at any of the
established locations within your company. Failure to promptly correct
these violations may result in regulatory action without further notice.
such as seizure and/or injunction.

The violations listed above are not intended co be all-inclusive. You as
a corporate official of this firm. have a responsibility to insure that
all drugs intended for veterinary use, which bear the human or
veterinary prescription legend, are sold by you or your firm properly
labeled as required.

It is necessary for you to take action on this matter now. Please let
this office know in writing within fifteen ( 15) working Jays from the
dare you received this letter what steps you are taking to correct the
problems. We also ask chat you explain how you plan to prevent this from
happening again. If you need more time, let us know why and when expect
to complete your correction.

Your reply should k sent to Clarence R. Pendleton, Compliance Officer,
at the above address.

Sincerely,

/s/

Charles W. Sedgwick

District Director

Kansas City District

http://www.fda.gov/foi/warning_letters/g3801d.htm

a few more of 100s;

SNIP...

Our investigation also found that you hold animals under
conditions which are so inadequate that medicated animals bearing
potentially harmful drug residues are likely
to enter the food supply....

SNIP...

http://www.fda.gov/foi/warning_letters/g2075d.pdf

may take some time to load, but worth reading.
check all the different antibiotics;

anitresistance antibiotics and animals usda
http://www.aphis.usda.gov/vs/ceah/cei/antiresist.entire.pdf

Medicated Feeds

http://63.75.126.221/scripts/wlcfm/subject.cfm?FL=M

Illegal Drug Residue/Adulterated

http://63.75.126.221/scripts/wlcfm/subject.cfm?FL=I

Illegal Drug Tissue Residue

http://63.75.126.221/scripts/wlcfm/subject.cfm?FL=I

Drug Residues/Edible Tissues/Adulterated

http://63.75.126.221/scripts/wlcfm/subject.cfm?FL=D

examples;

snip...

USDA testing revealed the presence of 0.23 ppm
(parts per million) penicillin in the kidney
tissue of the animal. This is considered to be
illegal tissue residue since the tolerance for
penicillin in edible bovine tissue is 0.05 ppm.
The presence of penicillin in the edible tissue
from your animal at the concentration level detected
renders the food from the animal to be adulterated
under section blah blah blah....

snip...

http://www.fda.gov/foi/warning_letters/m2268n.pdf

http://www.fda.gov/foi/warning_letters/g1225d.pdf

look under subject here;

http://63.75.126.221/scripts/wlcfm/sindex.cfm

or this url and search;

http://www.fda.gov/foi/warning.htm

most recent;

Van Haitsma Dairy Farm 12/14/01

Detroit District Office

Illegal Drug Tissue Residue/Adulterated

View File

http://www.fda.gov/foi/warning_letters/g2040d.pdf

more data on MRSA and VRSA;

LANCET
Volume 350, Number 9092
06 December 1997

Commentary

Vancomycin-resistant Staphylococcus aureus:
apocalypse now?

http://www.thelancet.com/

http://jama.ama-assn.org/issues/v283n5/ffull/jwr0202-1.html

http://wonder.cdc.gov/wonder/prevguid/m0049042/m0049042.asp

http://www.cdc.gov/ncidod/hip/ARESIST/mrsahcw.htm

http://www.scotland.gov.uk/library2/doc15/sim-01.asp

http://www.mbiotech.com/newsreleases/nr112800.htm

http://www.dent.ucla.edu/pic/members/antibiotics/vancomycin.html

http://www.nlm.nih.gov/medlineplus/druginfo/vancomycinsystemic202590.html

Greetings again Codex,

i hope i have at least provided enough evidence that
warrants further investigation to the past 3 or 4 decades
of lies past on to the consumer from the
FDA/USDA/APHIS/FSIS/NIH/CDC. we must BAN all rumiant-to-
ruminant SRMs/MRMs feeding in the USA, we must ban all
antibiotic and hormone use in cattle and all farm animals
for human consumption. and last but most importantly,
we must ban ALL POLITICIANS, INDUSTRY, AND LOBBYIST from
any scientific boards making decissions pertaining to these
topics. They are the very reason we are in the mess we are
in...

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






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