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Growth promotants make tough meat

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rancher

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Hormone growth promotants making cattle meat tougher: study

ABC NewsOnline - Australia

September 13, 2005



Extensive taste tests conducted by the Beef Cooperative Research Centre have found hormone growth promotants (HGP) used in cattle make the meat tougher.



The findings are to be published in the Australian Journal of Experimental Agriculture.



Professor of meat science at the University of New England, John Thompson says while the hormone implants may improve cattle's feed efficiency, the taste of a fresh steak can be compromised.



"The importance of the HGP effect on eating quality really depends on where that meat is going," he said.



"As you said if it's going for hamburgers there is no impact that the consumer would see but if it's going for prime steaks in the supermarket then yes the consumer would be able to pick up a difference."
 

agman

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rancher said:
Hormone growth promotants making cattle meat tougher: study

ABC NewsOnline - Australia

September 13, 2005



Extensive taste tests conducted by the Beef Cooperative Research Centre have found hormone growth promotants (HGP) used in cattle make the meat tougher.



The findings are to be published in the Australian Journal of Experimental Agriculture.



Professor of meat science at the University of New England, John Thompson says while the hormone implants may improve cattle's feed efficiency, the taste of a fresh steak can be compromised.



"The importance of the HGP effect on eating quality really depends on where that meat is going," he said.



"As you said if it's going for hamburgers there is no impact that the consumer would see but if it's going for prime steaks in the supermarket then yes the consumer would be able to pick up a difference."

One of the additional problems with growth stimulants is that it impacts the grade in the cattle-more select less choice at a given age or weight.
 

PPRM

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just talked t a guy that puts on a lot of cowhorse events in Central Oregon. He knows the ranchers he sources cattle from and who implants and who doesn't. His contention is that implanted cattle are harder to handle........

Hmmmm.... extra hormones making an animal a little more "prowley" when pressed...... ok, I'm about to get in lots of hot water here, but.... we Men have observed similar results for years, LOL,


PPRM
 

S.S.A.P.

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Hmmmm.... extra hormones making an animal a little more "prowley" when pressed...... ok, I'm about to get in lots of hot water here, but.... we Men have observed similar results for years, LOL,


PPRM



_________________
The difference between a rut and a grave is the depth

PPRM

Okay PPRM, I'll bite, but first - how deep do you want that grave? ... LOL
 

RobertMac

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agman said:
rancher said:
Hormone growth promotants making cattle meat tougher: study

ABC NewsOnline - Australia

September 13, 2005



Extensive taste tests conducted by the Beef Cooperative Research Centre have found hormone growth promotants (HGP) used in cattle make the meat tougher.


The findings are to be published in the Australian Journal of Experimental Agriculture.



Professor of meat science at the University of New England, John Thompson says while the hormone implants may improve cattle's feed efficiency, the taste of a fresh steak can be compromised.



"The importance of the HGP effect on eating quality really depends on where that meat is going," he said.



"As you said if it's going for hamburgers there is no impact that the consumer would see but if it's going for prime steaks in the supermarket then yes the consumer would be able to pick up a difference."

One of the additional problems with growth stimulants is that it impacts the grade in the cattle-more select less choice at a given age or weight.

What is more important...efficiency or producing an acceptable product?
Eliminate HGP and antibiotics...beef becomes acceptable to a larger portion of the population...increased demand!
Eliminate HGP...more higher priced choice...increased demand!
Eliminate HGP and antibiotics...opens the door to the EU market...increased demand!

Using HGP and antibiotic...making pennies, costing dollars!

IMHO, HGP is a fix for poor genetics.
 

Radar

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RobertMac, "Eliminate HGP and antibiotics...opens the door to the EU market...increased demand!"

I don't disagree with ya, cause in theory this would be true. In reality, I'm not so sure.
 

RobertMac

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Radar said:
RobertMac, "Eliminate HGP and antibiotics...opens the door to the EU market...increased demand!"

I don't disagree with ya, cause in theory this would be true. In reality, I'm not so sure.

You are right...we can't make a consumer buy our product. My solution would be 'Equal Trade'...we restrict your access to our market an equal amount you restrict our access to your market...we apply an equal tariff to your products that you apply on our products.
 

Andy

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What is the cost of not using HGP and antibiotics? I feel useing them is safe, but if it make the beef tougher that is something to be conserned about.
 

rkaiser

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RobertMac, "Eliminate HGP and antibiotics...opens the door to the EU market...increased demand!"

Radar -I don't disagree with ya, cause in theory this would be true. In reality, I'm not so sure.

There is currently an 11000 tonne import quota in place for exports from the USA and Canada that hasn't been used to it's max in years. The EU has gone from a net exporter of beef a couple of years back to a net importer of over 200,000 tonnes this year and projecting over 400,000 tonnes next year.

The EU would like North American beef. Especially the high end well marbled cuts in countries like Germany, Holland, Denmark etc. Our inability to bend on the hormone issue and the continued challenge with the WTO has held us back and allowed South America to make moves into their market.

There are opportunties in the EU, and lots of them. We are once again trying to force a customer to live with our standards and it will cost us in the end.
 

Mike

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Common Questions About Implanting

Are implanting and re-implanting nursing calves economically justified? Implanting a nursing calf increases its weaning weight 15 to 20 pounds, thereby adding $8.25 to $11.00 revenue to a calf sold for $0.55 per pound. This is achieved at a cost of about $1.25, including labor. Re-implanting market calves before weaning adds an additional 6 to 10 pounds of weaning weight to the 15 to 20 pounds gained from the first implant.

Will implants administered to calves before the feeding period decrease the response to implants administered later in the feedlot? An analysis of a large data base showed slaughter weights were increased by 30 pounds when implants were used in both pre-weaning and stocker phases and by 46 pounds in steers and 33 pounds in heifers when implants were used in the feedyard. These increases were observed whether or not implants had been administered in earlier phases of production.

Andy wrote:

What is the cost of not using HGP and antibiotics? I feel useing them is safe, but if it make the beef tougher that is something to be conserned about.

The article cited says that not only is tenderness and palatibility compromised with growth implants, it states that "Quality" grade is lowered also. The upshot is......Yield grades and Efficiency is improved.

I have no idea on the antibiotic question. I would think that the individual cattlemans health program would play a big part in the use, or non-use, of antbiotics in calves. We hardly ever have a case of scours down here, leaving it highly probable that calves never get an antibiotic.

I don't remember giving a calf a shot for anything other than a severe injury or foot rot, which is very seldom.
 

flounder

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Antibiotic use in livestock up slightly

AgWeb.com

9/14/2005



Antibiotic use in U.S. livestock was up 7.5% last year to 21.7 million lb. However, that’s still down from 1999, when some 24.4 million lb. were used, according to the Animal Health Insitute.



More importantly, 95% of antibiotics used in livestock are now for therapeutic use. That’s up from 83% in 2001.



The 5% used for health maintenance represents 1,175, 226 lb. Of this, about 65% has little or no use in human medicine, including ionophores and arsenicals. The remainder is comprised of four compounds, all of which have been or are being evaluated for human resistance risk.



--Source: Food Safety Digest/Summer 2005 received Sept. 14, 2005



agweb.com



http://www.ellinghuysen.com/news/articles/22075.shtml



> Hormone growth promotants making cattle meat tougher: study



IT ALSO MAKES HUMANS MORE SUSCEPTIBLE TO DISEASE SUCH AS MRSA DUE TO THE CONSUMPTION OF CATTLE SO PUMPED UP WITH ANTIBIOTICS AND HORMONES DUE TO THE FACT THEY ARE SO DISEASED AT SLAUGHTER



From: TSS ()
Subject: Antibiotics in Feed Becoming a Concern (IT'S BEEN A CONCERN...TSS)
Date: June 3, 2005 at 1:10 pm PST


Antibiotics in Feed Becoming a Concern

06/02/05 11:20


OMAHA (DTN) -- American agriculture uses about seven times the amount of antibiotics in livestock feed as is used in human medicine every year, according to a news release from Environmental Defense.


People living in areas where antibiotics are heavily used are at greater risk of developing antibiotic-resistant infections, according to Ellen Silbergeld, professor of environmental health services at Johns Hopkins Bloomberg School of Public Health, who was quoted in the release.


Most of the antibiotics in feed, 90 percent, are used in 23 states. Two states, Iowa and North Carolina, each use about 3 million pounds annually, equal to that used by humans nationwide.


The report, Resistant Bugs and Antibiotic Drugs: Local Estimates of Antibiotics in Agricultural Feed and Animal Waste, is the first study to provide state and county level estimates of the quantities of antibiotics used as feed additives for chicken, hogs and beef cattle, along with estimates for antibiotics in animal waste. The report is available at http://www.environmentaldefense.org/go/antibiotic.estimates.


At least one million pounds of antibiotics are estimated to be used as feed additives annually in seven states: Georgia, Arkansas, Texas, Alabama, Minnesota, Mississippi and Missouri. On a per square mile-adjusted basis, Delaware is estimated to be by far the most intensive user of all antibiotic feed additives, using three times as many antibiotics per thousand square miles (187,000 pounds) as the next closest state, North Carolina (64,000 pounds).


Two other smaller states join the ranks of the top 10 states on a per square mile basis, Maryland (4th) and Indiana (9th).


The Environmental Defense report estimates were prepared using new data from the U.S. Department of Agriculture on numbers of animals per county, and multiplying those figures by estimates previously developed by the Union of Concerned Scientists on the quantity of feed-additive antibiotics consumed per animal. UCS presented national estimates, but not state or county estimates.


"The public has a right to know where antibiotics are being used for nonessential purposes, notably as antibiotic feed additives," said Environmental Defense senior attorney Karen Florini, co-author of the report. "Unfortunately, no governmental data are available on quantities of antibiotics used in livestock feed either locally or nationally."


Overuse of antibiotics in agriculture is widely regarded as contributing to the spread of antibiotic-resistant bacteria that threaten human health. Antibiotics are added to feed not to treat sick animals, but rather on the grounds that they may promote slightly faster growth or prevent disease that could result from the crowded, stressful conditions.


"Feeding antibiotics to animals is not only a major cause of antibiotic-resistant bacteria in the human food supply, but also results in the presence of antibiotic-resistant bacteria in animals and in their waste," said Environmental Defense senior scientist Rebecca Goldburg, Ph.D., co-author of the report.


"Those bacteria can in turn colonize and infect farm workers, as well as contaminate water, air, and soil. "With antibiotics, the more you use them, the faster you lose them," concluded Goldburg. "That's because bacteria become resistant in response to being exposed to antibiotics. Antibiotic resistance is a serious and growing threat to human health, so it's just plain foolish to be feeding vast quantities of antibiotics to chickens, pigs, and beef cattle."


The report urges swift enactment of bipartisan federal legislation to phase out use of medically important antibiotics as feed additives, The Preservation of Antibiotics for Medical Treatment Act (S. 742/H.R. 2562), sponsored by U.S. Senator Olympia Snowe, R-Maine and U.S. Rep. Sherrod Brown, D-Ohio.


The bipartisan Senate version of this bill authorizes funds to farmers to help defray costs of phasing out non-therapeutic use of medically important antibiotics, and provides for research and demonstration projects to assist farmers in this transition.


More than 380 organizations, including the American Medical Association, American Academy of Pediatrics, and American Public Health Association, endorsed nearly identical legislation last year.


In April, Environmental Defense, American Academy of Pediatrics, American Public Health Association, Food Animal Concerns Trust and Union of Concerned Scientists filed a formal Citizen Petition with the Food and Drug Administration urging the agency to ban seven classes of medically important antibiotics from use as feed additives, and documenting that those uses violate FDA's specific safety standards for antibiotic use.




agdayta.com




Groups debate US plan on antibiotics for animals

USA: October 4, 2002

WASHINGTON - U.S. proposals aimed at protecting people from antibiotic resistance may limit options for livestock producers trying to keep animals healthy for the food supply, industry groups said.


Consumer groups, meanwhile, said they were encouraged that the Food and Drug Administration was moving to address a serious public health issue by recommending that makers of animal drugs evaluate whether the medicines will lead to people acquiring tough-to-treat infections from food.

"The problem is how does FDA do its job of being concerned about antibiotic resistance, yet at the same time not severely damage or even destroy the industry that produces these antibiotics," Deputy FDA Commissioner Lester Crawford said at a public hearing on the issue.

"I think the balance we are presenting today is well-crafted," Crawford added.

The FDA plan "is a great step forward. The agency actually is taking a stand on the use of antibiotics in animal agriculture," said John Balbus of Environmental Defense, which is a member of Keep Antibiotics Working, a coalition aiming to eliminate inappropriate use of antibiotics in farm animals.

Balbus said he is worried, though, about how quickly the FDA will act on its plan and whether the agency will have enough funding to carry it out. The coalition believes legislation to restrict some current uses of antibiotics in animals is the best way to address the problem, he said.

After repeated exposure to antibiotics, bacteria may learn to outsmart them. In a proposal unveiled last month, the FDA said it wants information about resistance risk when companies apply for approval of an animal drug. Based on the information, the agency may deny approval or restrict use.

Livestock producers and makers of animal drugs said the plan will make it harder to win approval for new medicines.

Barb Determan, a pork producer from Iowa, said she was worried that farmers and veterinarians may be prohibited from using medicines for uses that are not FDA-approved.

"We just want to make sure we have the thing that works right on our animals for keeping them healthy," she said.

Rich Carnevale, a vice president for the Animal Health Institute, said the FDA's current proposal "will overestimate the risk of many compounds and uses." The Animal Health Institute represents Pfizer Inc. , Bayer Corp. and other makers of animal drugs.


Story by Lisa Richwine


REUTERS NEWS SERVICE

http://www.planetark.org/dailynewsstory.cfm/newsid/18040/story.htm

greetings,

is something wrong with this picture here?

snip...

Barb Determan, a pork producer from Iowa, said she was worried that farmers and veterinarians may be prohibited from using medicines for uses that are not FDA-approved.

"We just want to make sure we have the thing that works right on our animals for keeping them healthy," she said.

snip...

by all means, to hell with the humans, just make sure the pigs
are fat full of hormones and antibiotics and medicines not
approved by FDA $$$

why is the FDA even there? they have very little power?

a trip last year to Methodist Hospital in Houston, Texas, and
my third neck surgery, i went in well intending to take all
precautions due to the risk of TSEs/CJDs in the hospital arena.
i refused cadaver bone for my neck, and refused blood
(which caused a stink, no where on the surgery work-up sheets
was any questions relating to human TSEs, and no one seemed
to care). at any rate, a veteran of sorts with neck surgeries,
and taking all precautions for the surgery from TSEs, and
prepared for anything (i thought). They even used some disposable
tools due to the potential risk of TSE due to my Mothers death.
Four days after surgery i was home on the road to recovery,
with my cervical spine all fused at c4-5, c5-6, and c6-7,
with a titanium plate screwed at 6 places on 3 levels.
Surgery on Nov. 30, and by the 11th or 12th of Dec. i started
getting sick, just did not feel right. where they took the bone
from my hip, started to itch, really bad (mom always said itching,
meant heeling?), the area started turning reddish, then the area
just blew up, and swelled really fast. Started running a temp.
that kept getting higher. Finally called the Emergency room
on a Sat. Spoke with a neurosurgeon that said to get to the
hospital immediately. had to wait two days, due to the infection
being so severe, before they could even operate. before surgery,
the area had become so swollen, (area where they took the bone
from my hip for my neck), if finally came to a head by monday.
my neurosurgeon walked in and saw it, pushed on the area, and
got about 8 OZ. of fluid right there in the hospital room.
he simply smelled of it, and said Terry, i think this is a
staph infection, of all people, i'm sorry. now when the infection
control team came in, it was a different story. they said it could
be a hundred of things, and did not want to speak of staph at that
time. 2 days later they came in and confirmed staph. another day
or two they confirmed MRSA. Then went back in, did a complete
wash-out of the area, took a lot more bone out of my hip
(infection had gotten into the bone), and several days later,
was then fitted with a 'long-line PIC', shooting 1000 mgs.
of VANCOMYCIN to my heart twice a day. was sent home with
PIC in place, and boxes and boxes of VANCOMYCIN. i would say
about in the 2nd or 3rd week, the blood work showed the
Vanco. was not doing it's job properly, so they then upped
my dose to 1250 mgs, twice a day, that seemed to hold up until
after 6 or 7 weeks of this Vanco. they stopped the treatment
and said my blood work looked good. after being released,
and never having my questions answered of whether or not the
MRSA was gone, or would it come back, or will the Vanco. work
next time, if there is a next time, could i transmit to wife,
i was sent home with some extreme pain in my chest, to this day,
still having them, but not nearly to the extent as then. So, i
guess i am cured? but no one could answer that? i have had all
my neck surgeries at Methodist, and with the same Neurosurgeon.
but once you get a hospital staph infection, and then have to
deal with their hospital infection control, you are completely
out of the hands of your doctor/neurosurgeon, and in the hands
of the hospital infection control team, and it just seemed like
i was going to the _company doctor_, so to speak. My insurance
company had to pay for all this, that the hospital (in my opinion)
was responsible for the infection control 'failure'. but what
caused me to become resistant, and many people around the globe
(in my opinion), can go in-directly to the cattle industry, pumping
so much antibiotics and hormones into cattle because they are so
sick when going to slaughter. This can be well documented at the
FDA warning letters site, under medicated/adulterated tissues.
i will post a few examples;

snip...

On or about October 26, 2001, you sold a cow (identified as cow #485 in your

records) for slaughter as human food to [redacted]. USDA analysis of
tissue samples collected from that animal identified the presence of
penicillin at 1.11 ppm in the kidney. A tolerance of 0.05 ppm has been
established for residues of penicillin in the edible tissues of cattle
(Title 21, Code of Federal Regulations, Part 556.510). The presence of
this drug in edible tissue from this animal causes the food to be
adulterated within the meaning of Section 402(a)(2)(C)(ii) of the Act.

Our investigation also found that you hold animals under conditions that
are so inadequate that 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 appropriate
periods of time to permit depletion of potentially hazardous residues of
drugs from edible tissues. As noted in form FDA-483 issued to you on
January 2, 2002, you did not follow the labeled withdrawal time of 10
days after treating your cow #485 with penicillin. Foods from animals
held under such conditions are adulterated within the meaning of Section
402(a)(4) of the Act.

You are adulterating the penicillin drug that your firm uses on cows
within the meaning of Section 50 1 (a)(5) when you fail to use the drug
in conformance with its approved labeling. Your use of the drug without
following the labeled withdrawal period causes the drug to be unsafe to use.

snip...

http://www.fda.gov/foi/warning_letters/g30

more examples;

On or about October 24, 2001, you sold a cow, identified by U.S.
Department of Agriculture (USDA) sample number 407433 and back tag
number 63IW 7890, for slaughter as human food at [redacted], through
[redacted]. USDA analysis of tissue samples collected from that cow
identified the presence of 7.12 parts pea-million (PPM) of gentamicin in
the kidney tissue. There is no established tolerance for gentamicin in
cattle (Title 21, Code of Federal Regulations (21 CFR), 556.300). The
presence of this

drug in the edible tissue from this animal causes the food to be
adulterated.

Our investigation also found that you hold animals under conditions,
which are so inadequate that 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 drugs
are used in a manner not contrary to the directions contained in the
labeling; and for assuring that animals medicated by you have been
withheld from slaughter for appropriate periods of time to permit
depletion of potentially

hazardous residues of drugs from edible tissues. Foods from animals held
under such conditions are adulterated.

http://www.fda.gov/foi/warning_letters/g3035d.htm

http://www.accessdata.fda.gov/scripts/wlcfm/subject.cfm?FL=A

medicated feeds (skroll to bottom)

http://www.accessdata.fda.gov/scripts/wlcfm/subject_archive.cfm?FL=M

streptomycin in the kidney;

http://www.fda.gov/foi/warning_letters/m869n.pdf

Twelve years ago, the European Union banned growth hormone use in both
domestic and imported meat because of worries that these compounds could
have human health effects.

http://europa.eu.int/abc/doc/off/bull/en/9604/p103109.htm

21 3. PREVALENCE OF ANTIMICROBIAL RESISTANCE IN PATHOGENS FROM HUMANS,
ANIMALS AND PLANTS, AND ITS IMPACT ON HEALTH AND PRODUCTIVITY
...........................................................................
Opinion of the SCAN on the criteria for assessing the safety of
micro-organisms resistant to antibiotics of human, clinical and
veterinary importance

Criteria for assessing the safety of micro-organisms resistant to
antibiotics of human, clinical and veterinary importance

http://europa.eu.int/comm/food/fs/sc/ssc/out50_en.pdf

http://europa.eu.int/comm/food/fs/sc/scan/out64_en.pdf

http://www.fda.gov/oc/opacom/hottopics/anti_resist.html

Bovine Embryos and Live Cattle: Imports from North America

The Earl of Caithness asked her Majesty's Government:

When the ban on the importation of embryos and live cattle from
North America will be lifted; and [HL3912]

What is the scientific evidence for the imposition of a ban on
the importation of embryos and live cattle from North America. [HL3913]

Lord Whitty: Her Majesty's Government have not imposed a ban on imports
of bovine embryos and live cattle from North America.

The European Parliament and European Council introduced legislation in
May last year laying down rules for the prevention, control and
eradication of certain transmissible spongiform encephalopathies (TSEs).
The legislation was introduced in response to the recommendations of the
Office International des Epizooties (OIE--the international animal health
organisation) and advice from the Commission's scientific comittees. The
legislation (and the transitional measures which came into effect in
October last year) includes requirement that imports into the EU of
bovine embryos and live cattle must be accompanied by certification
confirming that the feeding of ruminants with protein derived from
mammals has been banned and that the ban has been effectively enforced.
Some exporting countries, such as Canada and the USA, are currently
unable to meet these new requirements.

http://www.publications.parliament.uk/pa/ld199697/ldhansrd/pdvn/lds02/text/20425w04.htm#20425w04_sbhd2

thank you,
kind regards,

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

CJD WATCH
http://www.fortunecity.com/healthclub/cpr/349/part1cjd.htm

ProMED-mail wrote:

> STAPH. AUREUS, VISA - UK (ENGLAND)
> **********************************
> A ProMED-mail post
>
> ProMED-mail is a program of the
> International Society for Infectious Diseases
>
>
> [1] Report of reduced susceptibility isolate
> [2] Comments on hospital cleanliness
>
>
> [1]
> Date: Fri 17 May 2002 10:06 AM EDT
> From: ProMED-mail
> Source: BBC news, 17 May 2002 [edited]
>
>
>
> [Our thanks to Martha Cosgriff for submitting this article as well. Mod.MPP]
>
> Tougher superbugs reach England
> ----------------------------------------------
> Doctors fear that their drug defenses against hospital superbugs are
> weakening after a patient was diagnosed with a new strain. Bacteria
> resistant to many classes of antibiotics are rife in many UK hospitals.
> However, even in the most extreme cases, doctors could turn to the
> antibiotic vancomycin to clear the infection [for organisms such as
> methicillin-resistant _Staph. aureus_ (MRSA) - Mod.LL].
>
> In the latest case, the unnamed patient [in an unnamed location - Mod.LL]
> developed an infection that had shown a low-level resistance even to this
> class of drugs. It is the first such case in England, although there have
> been vancomycin-resistant strains uncovered in Scotland, as well as in
> France, Japan, and the US. An earlier scare in Bristol involved bacteria
> which turned out to have insignificant resistance to the drug.
>
> The patient involved later died, although the infection is not thought to
> have been the cause. Hospital officials believe that no one else in the
> building has acquired the bacteria.
>
> "Superbugs" such as MRSA are thought to cost thousands of lives - and
> hundreds of millions of pounds to the NHS each year. Poor hospital hygiene
> practices are thought by many to contribute to the problem, and in July
> 2000, the government launched a 60-million-pound drive to improve cleanliness.
>
> However, another key factor is the heavy use of antibiotics, particularly
> in the hospital environment. Exposure to these drugs eventually leads to
> the survival of strains whose genetic makeup lends itself to drug
> resistance as weaker, competing strains are killed off. [Many
> antimicrobial-susceptible strains are not at all necessarily weaker; in
> many cases, the more resistant strain may be a weaker pathogen -Mod.LL].
>
> Dr Georgia Duckworth, from the Public Health Laboratory Service (PHLS),
> which monitors infectious disease in the UK, said: "With the development of
> antibiotic resistance, _Staph. aureus_ infections have become harder to
> treat as there are fewer antibiotics that are effective. Since the
> discovery of MRSA, vancomycin has been the first choice antibiotic used in
> its treatment. This first case in England is a serious development."
>
> Scientists are racing to develop new types of antibiotics as resistant
> strains of bacteria render existing drugs increasingly ineffective. New
> classes of drugs have been introduced in recent years, but doctors are
> still being urged to cut back on antibiotic usage wherever possible to slow
> down the arrival of resistance.
>
> Dr Duckworth said: "It underscores the fact that there is no cause for
> complacency in antibiotic usage - whenever we use an antibiotic, even if
> totally appropriately, we encourage the development of resistance to it."
>
> ******
> [2]
> Date: 17 May 2002
> From: ProMED-mail
> Source: The Scotsman (UK) [edited]
>
>
>
> Hospitals said to be dirtier than abattoirs
> ------------------------------------------------
> One of Scotland's leading infections experts last night criticized hygiene
> in NHS hospitals as being worse than that in slaughterhouses.
>
> Hugh Pennington, a professor of bacteriology at Aberdeen University, said
> abattoirs have better facilities to prevent infection than most hospitals.
> But as he spoke Scotland's health service was warned that further
> improvements in cleanliness would never eradicate superbugs, and new drugs
> would only buy time before they became resistant to those treatments as well.
>
> Professor James Naismith, from St Andrews University, warned the antibiotic
> vancomycin was the last line of defense against MRSA
> [(methicillin-resistant _Staph. aureus_)], but the superbug was already
> becoming resistant to the drug [at least less sensitive - Mod.LL].
>
> The scientists' comments followed a survey which revealed that over half of
> patients treated in NHS hospitals thought their homes were cleaner than the
> wards. Prof Pennington said: "If our hospitals were kept at the level of
> cleanliness that slaughterhouses currently observe, it would be a far
> better deal for the patients. 10 percent of people who go into hospital
> contract an infection while they're in there and all of these infections
> are preventable with improved hygiene [at least a goodly number of them -
> Mod.LL]. Staff who work in a modern slaughterhouse wash their hands every
> 5 minutes. The NHS do not always make it easy for their staff to wash their
> hands when they need to. Just having more hand-wash basins and putting
> them in the right place could make a huge difference."
>
> Meanwhile, Prof Naismith issued his warning over superbugs after receiving
> a GBP 637 000 grant from the Wellcome Trust for a study of the structure of
> vancomycin in an effort to find new ways of fighting MRSA.
>
> [Byline: Kate Foster and Alastair Dalton]
>
> --
> ProMED-mail
>
>
> [A number of reports of MRSA demonstrating reduced susceptibility to
> vancomycin have occurred since 1997 and are noted below. These isolates
> called VISA (vancomycin-intermediate _Staph. aureus_) or GISA
> (glycopeptide-intermediate _Staph. aureus_) have generally been isolated
> from patients who have had prolonged exposure to vancomycin in a hospital
> setting. Fortunately, serious life-threatening illness was not usually
> associated with this infection, and high doses of vancomycin were still
> effective. Many isolates of another organism (Enterococcus), however,
> previously uniformly sensitive to vancomycin, have developed high-grade
> resistance to the drug. Fortunately, the enterococcus is not always a
> significant pathogen in people, but it would be quite problematic if such a
> resistance pattern appeared in _Staph. aureus_ or _Strep. pneumoniae_ and
> those organisms were virulent. A new antimicrobial, linezolid, does have
> activity against the vancomycin-resistant enterococcus and is active
> against Staph. as well. However, only time and increasing use are needed
> for linezolid-resistant strains of these organisms to become
> prevalent. The 2 issues discussed in the reports, overuse of
> antimicrobials (especially in the hospital setting) and inadequately
> followed infection control procedures, contribute to the development and
> spread of resistant strains, respectively.
>
> Ultimately, it is not likely that we will eradicate such resistant strains,
> but judicious use of antimicrobials and aggressive enforcement of
> handwashing and other infection control procedures can limit the impact of
> these organisms. - Mod.LL]
>
> [see also:
> 1999
> ----
> Vancomycin resist. S. aureus - China (Hong Kong) (04) 19991109.2008
> Staph. Aureus, VISA - UK (Scotland) 19990621.1056
> 1998
> ----
> Staphylococcus aureus, vancomycin res. - USA (New York) 19980426.0791
> Vancomycin resistance, intermed., S. aureus - Europe 19980108.0057
> 1997
> ----
> Staph. Aureus, reduced susceptibility to Vancomycin (02) 19970907.1928
> Staph. Aureus, vancomycin resistant - USA 19970825.1775]
> ...........................ll/pg/mpp
>
> *##########################################################*
> ProMED-mail makes every effort to verify the reports that
> are posted, but the accuracy and completeness of the
> information, and of any statements or opinions based
> thereon, are not guaranteed. The reader assumes all risks in
> using information posted or archived by ProMED-mail. ISID
> and its associated service providers shall not be held
> responsible for errors or omissions or held liable for any
> damages incurred as a result of use or reliance upon posted
> or archived material.
> ************************************************************
> Visit ProMED-mail's web site at .
===============================================================

more warning letters....tss

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

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

Morbidity and Mortality Weekly Report


Staphylococcus aureus Resistant to Vancomycin [mdash] United States, 2002

MMWR. 2002;51:565-567

Staphylococcus aureus is a cause of hospital- and community-acquired infections.1,2 In 1996, the first clinical isolate of S. aureus with reduced susceptibility to vancomycin was reported from Japan.3 The vancomycin minimum inhibitory concentration (MIC) result reported for this isolate was in the intermediate range (vancomycin MIC = 8 µg/mL) using interpretive criteria defined by the National Committee for Clinical Laboratory Standards.4 As of June 2002, eight patients with clinical infections caused by vancomycin-intermediate S. aureus (VISA) have been confirmed in the United States.5,6 This report describes the first documented case of infection caused by vancomycin-resistant S. aureus (VRSA) (vancomycin MIC 32 µg/mL) in a patient in the United States. The emergence of VRSA underscores the need for programs to prevent the spread of antimicrobial-resistant microorganisms and control the use of anti-microbial drugs in health-care settings.

In June 2002, VRSA was isolated from a swab obtained from a catheter exit site from a Michigan resident aged 40 years with diabetes, peripheral vascular disease, and chronic renal failure. The patient received dialysis at an outpatient facility (dialysis center A). Since April 2001, the patient had been treated for chronic foot ulcerations with multiple courses of antimicrobial therapy, some of which included vancomycin. In April 2002, the patient underwent amputation of a gangrenous toe and subsequently developed methicillin-resistant S. aureus bacteremia caused by an infected arteriovenous hemodialysis graft. The infection was treated with vancomycin, rifampin, and removal of the infected graft. In June, the patient developed a suspected catheter exit-site infection, and the temporary dialysis catheter was removed; cultures of the exit site and catheter tip subsequently grew S. aureus resistant to oxacillin (MIC >16 µg/mL) and vancomycin (MIC >128 µg/mL). A week after catheter removal, the exit site appeared healed; however, the patient's chronic foot ulcer appeared infected. VRSA, vancomycin-resistant Enterococcus faecalis (VRE), and Klebsiella oxytoca also were recovered from a culture of the ulcer. Swab cultures of the patient's healed catheter exit site and anterior nares did not grow VRSA. To date, the patient is clinically stable, and the infection is responding to outpatient treatment consisting of aggressive wound care and systemic antimicrobial therapy with trimethroprim/sulfamethoxazole.

The VRSA isolate recovered from the catheter exit site was identified initially at a local hospital laboratory using commercial MIC testing and was confirmed by the Michigan Department of Community Health and CDC. Identification methods used at CDC included traditional biochemical tests and DNA sequence analysis of gyrA and the gene encoding 16S ribosomal RNA. Molecular tests for genes unique to enterococci were negative. The MIC results for vancomycin, teicoplaninin, and oxacillin were >128 µg/mL, 32 µg/mL, and >16 µg/mL, respectively, by the broth microdilution method. The isolate contained the vanA vancomycin resistance gene from enterococci, which is consistent with the glycopeptide MIC profiles. It also contained the oxacillin-resistance gene mecA. The isolate was susceptible to chloramphenicol linezolid, minocycline, quinupristin/dalfopristin, tetracycline, and trimethoprim/sulfamethoxazole.

Epidemiologic and laboratory investigations are under way to assess the risk for transmission of VRSA to other patients, health-care workers, and close family and other contacts. To date, no VRSA transmission has been identified.

Infection-control practices in dialysis center A were assessed; all health-care workers followed standard precautions consistent with CDC guidelines.7 After the identification of VRSA, dialysis center A initiated special precautions on the basis of CDC recommendations,8 including using gloves, gowns, and masks for all contacts with the patient; performing dialysis with a dedicated dialysis machine during the last shift of the day in an area separate from other patients; having a dialysis technician dedicated to providing care for the patient; using dedicated, noncritical patient-care items; and enhancing education of staff members about appropriate infection-control practices. Assessment of infection-control practices in other health-care settings in which the patient was treated is ongoing.


Reported by:

DM Sievert, MS, ML Boulton, MD, G Stoltman, PhD, D Johnson, MD, MG Stobierski, DVM, FP Downes, DrPH, PA Somsel, DrPH, JT Rudrik, PhD, Michigan Dept of Community Health; W Brown, PhD, W Hafeez, MD, T Lundstrom, MD, E Flanagan, Detroit Medical Center; R Johnson, MD, Detroit; J Mitchell, Oakwood Health Care System, Dearborn, Michigan. Div of Healthcare Quality Promotion, Div of Bacterial and Mycotic Diseases, National Center for Infectious Diseases; S Chang, MD, EIS Officer, CDC.


CDC Editorial Note:

This report describes the first clinical isolate of S. aureus that is fully resistant to vancomycin. S. aureus causes a wide range of human infections and is an important cause of health-care associated infections. The introduction of new classes of antimicrobials usually has been followed by emergence of resistance in S. aureus. After the initial success of penicillin in treating S. aureus infection, penicillin-resistant S. aureus became a major threat in hospitals and nurseries in the 1950s, requiring the use of methicillin and related drugs for treatment of S. aureus infections. In the 1980s, methicillin-resistant S. aureus emerged and became endemic in many hospitals, leading to increasing use of vancomycin. In the late 1990s, cases of VISA were reported.

Although the acquired vancomycin-resistance determinants vanA, vanB, vanD, vanE, vanF, and vanG have been reported from VRE, these resistance determinants have not previously been identified in clinical isolates of S. aureus.9 Conjugative transfer of the vanA gene from enterococci to S. aureus has been demonstrated in vitro.10 The presence of vanA in this VRSA suggests that the resistance determinant might have been acquired through exchange of genetic material from the vancomycin-resistant enterococcus also isolated from the swab culture. This VRSA isolate is susceptible in vitro to several antimicrobial agents, including antimicrobials recently approved by the Food and Drug Administration (i.e., linezolid and quinupristin/dalfopristin) with activity against glycopeptide-resistant Gram-positive microorganisms.

In 1997, the Healthcare Infection Control Practices Advisory Committee published guidelines for the prevention and control of staphylococcal infection associated with reduced susceptibility to vancomycin8; plans to contain VISA/VRSA on the basis of CDC recommendations have been established in some state health departments. In the health-care setting, a patient with VISA/VRSA should be placed in a private room and have dedicated patient-care items. Health-care workers providing care to such patients should follow contact precautions (i.e., wearing gowns, masks, and gloves and using antibacterial soap for hand washing). These control measures were adopted by dialysis center A immediately following confirmation of the VRSA isolate. To date, there has been no documented spread of this microorganism to other patients or health-care workers.

Strategies to improve adherence to current guidelines to prevent transmission of antimicrobial resistant micro-organisms in health-care settings should be a priority for all health-care facilities in the United States. S. aureus should be tested for resistance to vancomycin using a MIC method. The isolation of S. aureus with confirmed or presumptive vancomycin resistance should be reported immediately through state and local health departments to the Division of Healthcare Quality Promotion, National Center for Infectious Diseases, CDC, telephone 800-893-0485.

References: 10 available

© 2002 American Medical Association. All rights reserved.

Epidemiology

First case of fully vancomycin-resistant S. aureus infection in the US reported

Last Updated: 2002-07-03 14:34:22 -0400 (Reuters Health)

By Mean Rauscher

NEW YORK (Reuters Health) - The first documented case in the US of infection caused by Staphylococcus aureus that is fully resistant to vancomycin has federal health officials at the Centers for Disease Control and Prevention (CDC) in Atlanta concerned.

In a telebriefing Wednesday, Dr. Steve Solomon, medical epidemiologist at the CDC, said, "this case serves to reinforce the absolute necessity of adhering to strict infection control precautions, as has been done in this case--and to continue to use antibiotics wisely."

Dr. Solomon also said this case represents an evolution in drug resistance in this particular microorganism, which has been going on for 50 years.

The first S. aureus isolate with reduced susceptibility to vancomycin (vancomycin-resistant Staphylococcus aureus, or VRSA) was reported in Japan in 1996, the CDC notes in the Morbidity and Mortality Weekly Report for July 5th. As of June 2002, eight confirmed cases of infections caused by S. aureus isolates with "intermediate" susceptibility to vancomycin have been reported in the US.

The first fully resistant S. aureus infection in the US was confirmed in June. The patient is a 40-year-old Michigan resident with complicated diabetes, peripheral vascular disease, and chronic renal failure for which he receives regular hemodialysis at an outpatient center. The patient had been taking multiple antibiotics, including vancomycin, for chronic foot ulcerations.

In April 2002, he had a gangrenous toe amputated. When he later developed methicillin-resistant S. aureus bacteremia due to an infected hemodialysis graft, his physicians removed the infected graft and he initiated vancomycin and rifampin treatment.

Subsequently, a swab taken from a catheter exit site infection revealed VRSA (MIC >128 µg/mL). The isolate was also resistant to oxacillin (MIC >16 µg/mL). Swabs from the patient's infected chronic foot ulcer also revealed VRSA, as well as vancomycin-resistant Enterococcus faecalis (VRE) and Klebsiella oxytoca.

According to the CDC, the patient responded to aggressive wound care and trimethoprim/sulfamethoxazole. Dr. Solomon said it's "reassuring" that the VRSA isolate was also susceptible to chloramphenicol, linezolid, minocycline, quinupristin/dalfopristin, and tetracycline.

It's also reassuring, Dr. David Johnson, deputy director and chief medical executive for the Michigan Department of Community Health in Lansing, told Reuters Health, that "swab samples from several hundred potential contacts show no evidence that the VRSA isolate has been transmitted."

The CDC recommends that all S. aureus isolates be tested for resistance to vancomycin and those with confirmed or presumptive vancomycin resistance be reported through state and local health departments to the CDC.

MMWR 2002;51:565-567.

Copyright © 2002 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of th

Vancomycin

(van-koe-MY-sin)


Trade Name(s):
* Lyphocin Powder for Injection, lyophilized
* 500 mg Powder for Injection, lyophilized
* 1 g Powder for Injection, lyophilized
* 5 g Powder for Injection, lyophilized
10 g
* Vancocin Pulvules
* 125 mgPulvules
* 250 mgPowder for Oral Solution
* 1 gPowder for Oral Solution
* 10 gPowder for Injection
* 500 mg Powder for Injection
* 1 g Powder for Injection
10 g
* Vancoled Powder for Injection
* 500 mg Powder for Injection
* 1 gPowder for Injection
5 g
Indicates Canadian trade names.

Class: Anti-infectiveAntibiotic

Action:
Inhibits bacterial cellwall synthesis and alters cell-membrane permeability and RNA synthesis.

Indications:

Parenteral: Treatment of serious or severe infections due to susceptible bacteria not treatable with other antimicrobials (eg, staphylococcus).

Oral: Treatment of pseudomembranous colitis caused by Clostridium difficile; treatment of staphylococcal enterocolitis. Unlabeled use(s): IV prophylaxis against bacterial endocarditis in penicillin-allergic patients.

Contraindications:
Standard considerations.

Route/Dosage:

Adults:
PO 500 mg to 2 g/day in 3 or 4 divided doses for 7 to 10 days.

Children:
PO 40 mg/kg/day (up to 2 g/day) in 3 or 4 divided doses for 7 to 10 days.

Newborns:
PO 10 mg/kg/day in divided doses.

Adults:
IV 500 mg by IV infusion q 6 hr or 1 g q 12 hr.

Children:
IV 10 mg/kg/dose q 6 hr.

Infants & Newborns:
IV 15 mg/kg initially, followed by 10 mg/kg q 12 hr for newborns in first week of life, and q 8 hr for ages up to 1 mo.

Interactions:

Aminoglycosides: May increase risk of nephrotoxicity.

Neurotoxic and nephrotoxic agents: May give additive toxicity.

Nondepolarizing muscle relaxants: Neuromuscular blockade may be enhanced.

INCOMPATIBILITIES: IV solution is incompatible with alkaline injections.

Lab Test Interferences:
None well documented.

Adverse Reactions:

CV:
Hypotension.DERM:
Rash; urticaria; pruritus; inflammation at site of injection. EENT:
Hearing loss.GI:
Nausea.GU:
Increased serum creatinine and BUN; renal failure.HEMA:
Neutropenia; eosinophilia.RESP:
Wheezing; dyspnea.OTHER:
Anaphylaxis; drug fever; chills; Red Man Syndrome (hypotension with or without rash over face, neck, upper chest, and extremities).

Precautions:

Pregnancy: Category C.

Lactation: Excreted in breast milk.

Children: Confirming serum levels may be appropriate in newborns. Use of vancomycin with anesthetics may cause erythema and flushing.

Special risk patients: Use with caution in patients with preexisting hearing loss, patients receiving ototoxic or nephrotoxic drugs, patients receiving drugs that cause neutropenia; patients with renal impairment; elderly; newborns.

Hypotension: Too rapid IV infusion or bolus administration may be associated with exaggerated hypotension, including shock and cardiac arrest, with or without maculopapular rash over face, neck, upper chest, and extremities (Red Man or Redneck syndrome). Reaction has been rarely associated with slow infusion or oral or intraperitoneal administration.

Reversible neutropenia: May occur after total dose of 25 g.

Tissue irritation, thrombophlebitis: Give by secure IV route. May minimize thrombophlebitis by giving slowly as dilute infusion.
Patient Care Considerations

Administration/Storage:

* Prepare oral solution by adding 115 mL of water to 10 g vial or 20 mL of water to 1 g vial. Further dilute prepared oral solution dose with 30 mL of water or flavoring syrups may be used with oral solution.
* May give oral solution via nasogastric tube as indicated or ordered.
* Reconstitute parenteral form with Sterile Water for Injection.
* Further dilute parenteral medication with compatible solution (eg, 5% Dextrose Injection, 0.9% Sodium Chloride, Lactated Ringer's)
* Parenteral form may be administered by oral route.
* Reconstituted oral solution may be stored in refrigerator for 2 wk after bottle is opened.
* Dilute to minimum dilution of 2.5 mL and infuse parenteral solution over at least 60 min. Intermittent infusion preferred.
* Pretreat with antihistamine if patient has previously experienced Red Man Syndrome.
* Dosage or dosage interval may be changed based upon vancomycin serum levels.
* Reconstituted powder for injection is stable at room temperature for 2 wk.
* Dilute solutions (sodium chloride or D5W) are stable at room temperature for 24 hr.

Assessment/Interventions:

* Obtain patient history, including drug history and any known allergies.
* Assess results of culture and sensitivity to determine sensitivity.
* Assess hearing acuity before and after therapy. Anticipate ototoxicity.
* Monitor for signs of superinfection.
* Monitor skin for Red Man Syndrome with each dose infused.
* Notify health care provider of elevated BUN and creatinine, which indicate nephrotoxicity.
* Document hematuria and notify health care provider.
* Monitor I&O, BP for hypotension, and respirations for wheezing or dyspnea.
* Maintain adequate fluid intake.
* Obtain blood levels, new order, or protocol. Keep blood levels between 10 to 20 mcg/mL.
* Ensure that resuscitation equipment is available.


OVERDOSAGE: SIGNS & SYMPTOMS
Increase serum creatinine, increase BUN, hearing loss, ringing in ears, vertigo

Patient/Family Education:

* Explain that IV medication is given at regular intervals to maintain blood levels.
* Tell patient to report hearing loss, ringing in ears, or vertigo to health care provider.
* Explain signs of superinfection (eg, vaginitis).
* Identify symptoms of potential adverse reactions.
* Tell patient to maintain adequate fluid intake.

AtoZ Drug Facts · Copyright©2000 by Facts and Co

http://www.reutershealth.com/cgi-bin/frame2?top=/tops/med.html&left=/medl.html&right=/archive/2002/07/02/professional/links/20020702scie001.html

AJIC - American Journal of Infection Control
Vol. 30, No. 4, June 2002
ISSN: 0196-6553
EISSN: 1527-3296
SELECT:

Table of Contents ? Article(PDF)


Banning artificial nails from health care settings

pp. 252-254 (doi:10.1067/mic.2002.122102)
Lisa Saiman MD, MPHa , Audrey Lerner RN, BSN, CICa , Linda Saal MA, RNb , Elizabeth Todd RN, MPHa , Margaret Fracaro RN, MA, CICa , Nancy Schneider MSN, CICa , Joseph A. Connell JD, PA-Cc , Andria Castellanos MBAd , Brian Scully MDa , Lewis M. Drusin MD, MPHa

>From the Departments of Epidemiology,a Nursing,b Human Resources,c and Hospital Administration,d New York Presbyterian Hospital.


DEPARTMENT OF HEALTH AND HUMAN SERVICE

Public Health Service

Food and Drug Administration
Kansas City District
Southwest Region
11630 West 80 Street
P.O. Box 15905
Lenexa. Kansas 662855905
Telephone: (913) 752-2100

CERTIFIED MAIL
RETURN RECEIPT REQUESTED
May 8, 2002
WARNING LETTER
KAN #2002-06

Brent J. Rus, Owner
Brent Rus Farm
3330 & 3287 Dogwood Avenue
Rock Valley, IA 51247

Dear Mr. Rus:

A tissue residue report received by the Food and Drug Administration (FDA) from the United States Department of Agriculture (USDA) reported the presence of illegal drug residues in a cow that originated from your cattle raising operation. As a follow-up to USDA?s finding, our investigator performed an inspection of your operation located in Rock Valley, Iowa, on March 21 to 25, 2002. The inspection revealed serious violations of Section 402 and 501 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. On/about February 12, 2002, you offered a cow, identified with back tag number 41 MN 4358 (USDA laboratory report number 442053) for slaughter as human food. USDA analysis of tissue samples collected from that cow identified the presence of the drugs penicillin in the kidney at 0.55 parts per million (ppm), gentamicin in the kidney at 6.09 ppm, and sulfamethazine in the muscle at 6.22 ppm. Presently, the tolerance level for penicillin and sulfamethazine in the edible tissues of cattle is 0.05 ppm and 0.1 ppm respectively. There is no tolerance for gentamicin in the edible tissues of cattle.

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 the 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, you lack an adequate system for assuring that animals have been treated only with drugs which have been approved for use in those species; for assuring that drugs are used in a manner not contrary to the directions contained in the labeling; and for assuring that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues.

You are adulterating the drugs penicillin, gentamicin and sulfamethazine that you use on cattle within the meaning of Section 501(a)((5) when you fail to use the drugs in conformance with its approved labeling. Your use of the drugs in a species for which it is not approved, at a higher than labeled dosage, or without following labeled withdrawal periods, causes the drugs to be unsafe to use.

This 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 operation 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 such as seizure and/or injunction.

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

You should notify our office in writing, within fifteen (15) working days of the receipt of this letter, of the specific steps you have taken to correct these violations and preclude their recurrence. If corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which corrections will be completed. Your response should address each discrepancy brought to your attention during the inspection and in this letter, and should include copies of any documentation demonstrating that corrections have been made. Please direct your reply to Clarence R. Pendleton, Compliance Officer, at the address listed above.

Sincerely,

Charles W. Sedgwick

District Director

Kansas City District

=====

MRSA IN HOSPITALS


http://www.publications.parliament.uk/pa/ld199697/ldhansrd/pdvn/lds03/text/30430-08.htm#30430-08_unstar0


TSS
 

Mike

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Myth: The use of antibiotics and hormone growth implants in livestock production is causing hazardous residues in beef and contributing to the development of health problems in humans.

Fact:

1.

No residues from feeding antibiotics are found in beef, and there is no valid scientific evidence that antibiotic use in cattle causes illness resulting from the development of antibiotic-resistant bacteria.
2.

Scientific authorities agree that use of hormone implants results in the efficient production of beef that is safe.



Background: Some say that low-level, continuous feeding of penicillin and tetracyclines to livestock and poultry for growth promotion may result in development of antibiotic resistant bacteria and thus contribute to human illness. The National Academy of Sciences says it has never found data directly implicating subtherapeutic use of feed microbials as a risk factor in human illness.

Penicillin is not fed to cattle. For several years, there has been little subtherapeutic feeding of tetracyclines to cattle, even though such use continues to be approved as safe. There is no valid scientific evidence that feeding antibiotics to beef cattle causes human health problems. A recent report by USDA's Food Safety and Inspection Service showed no antibiotic residue problems with beef cattle.

Whether or not antibiotics are used in animals, resistant organisms will exist. But all are sensitive to heat, and proper cooking will kill all disease-causing bacteria that may be found in beef products.

Hormones

Hormones are naturally present in infinitesimal amounts in all meat, whether from implanted animals or not. The amount of estrogen in plant-source foods is larger than in meat. The human body produces hormones in quantities much greater than would ever be consumed by eating beef or other foods. Hormones in beef from implanted steers have no physiological significance for humans whatsoever. The estrogen level in a 3-oz. serving of beef from an implanted steer is 1.85 nanograms (a nanogram is a billionth of a gram); the level in the same
size portion of beef from a non-implanted steer is 1.3 nanograms. By comparison, a non-pregnant woman produces 480,000 nanograms of estrogen daily.

Hormone implants also increase the efficiency of beef production, thus alleviating energy, feed usage and environmental impacts, and improve overall quality and healthfulness of beef by reducing the amount of fat. The increased efficiency implants offer saves U.S. families hundreds of dollars each year by lowering the cost of retail beef by 20 cents to 30 cents per pound [IVD50 - 49].

Cattle producers continue to be actively involved in assuring that beef products are safe and wholesome for consumers. Forty-one states have industry-initiated beef quality assurance programs that educate producers on the production of safe and healthful beef products and prevention of hazardous residues. Participating states account for 98% of the nation's feedlot cattle and 95% of the country's breeding cows. [BB, 3.5 - 50].

References

* Antibiotics for Animals: The Antibiotic Resistance Issue, Council for Agricultural Science and Technology, 1989.
* Chemicals in the Meat Supply -- a Review, F.M. Byers, Texas A&M University, 1990.
Expert Committee on Additives, Food and Agricultural Organization/World Health Organization, 1987.
* Food News for Consumers, Food Safety and Inspection Service, Winter 1990. 49 - Food Safety in the Beef Cattle Industry, Harlan D. Ritchie, Michigan State University, proceedings, The LaCosta Conference on "Cattle on the Land: Environmental Implications of Beef Production, 1990.
* Report on Regulatory Program for Drug and Pesticide Residues in Meat and Poultry, 1989, Richard L. Carnevale, Food Safety and Inspection Service, 1990.
* Report on Use of Hormonal Substances in Animals, Inter-American Institute for Cooperation on Agriculture, 1986.
* Subtherapeutic Use of Antibiotics in Fed Animals Reviewed, Food & Drug Administration, 1989.
 

flounder

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> Penicillin is not fed to cattle. For several years, there has been little subtherapeutic feeding of tetracyclines to cattle, even though such use continues to be approved as safe. There is no valid scientific evidence that feeding antibiotics to beef cattle causes human health problems. A recent report by USDA's Food Safety and Inspection Service showed no antibiotic residue problems with beef cattle. <<<


well, i simply disagree, no big deal. common sense will tell you,
we were all told as children and adults (at least i was), that if doctors
over prescribes and or if humans take antibiotics like candy, you will
become resistant to them. i have heard it all my life.

should this not apply to cattle as well?




FIRST, about your statement that penicillin is not fed to cattle;


Public Health Service
Food and Drug Administration

Seattle District
Pacific Region
22201 23rd Drive SE
BothelI, WA 98021-4421
Telephone: 425-486-8788
FAX: 425-483-4996






August 10, 2005

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

In reply refer to Warning Letter SEA 05-29

Mike D. Griffith, Partner
G & G Dairy
2627 Morning Sun Drive
Twin Falls, ID 83301

WARNING LETTER

Dear Mr. Griffith:

On May 12-13, 2005, our investigator inspected your dairy farm located at 328 South 300 East, Jerome, Idaho. This inspection 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)], and you caused a new animal drug to be unsafe under section 512(a) of the Act [21 U.S.C. 360b(a)] and adulterated within the meaning of section 501(a)(5) of the Act [21 U.S.C. 351(a)(5)].

A food is adulterated under section 402(a)(2)(C)(ii) of the Act [21 U.S.C. 342(a)(2)(C)(ii)] if it contains a new animal drug that is unsafe within the meaning of section 512(a) of the Act [21 U.S.C. 360b(a)]. You sold a dairy cow on February 22, 2005, identified with back tag # [redacted] and USDA Case # 8-0312-05, and further identified as USDA-FSIS lab report # 455948, for slaughter as human food to [redacted]. USDA analysis-of tissue samples collected from that animal identified the presence of penicillin in the kidney at 1.22 parts per million (ppm) and in the muscle at 0.42 ppm. The tolerance for penicillin in edible tissues of dairy cattle is 0.05 ppm (Title 21, Code of Federal Regulations, section 556.510). The presence of this drug inedible tissue from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) [(21 U.S.C. 342(a)(2)(C)(ii)].

A food is adulterated under section 402(a)(4) of the Act [21 U.S.C. 342(a)(4)] "if it has been prepared, packed, or held under insanitary conditions . . .whereby it may have been rendered injurious to health." Our investigation found 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:

1. You lack an adequate system for assuring that the medicated animals have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues.

2. You lack adequate written treatment records for animal drugs administered to your herd. You could not produce treatment records for the dairy cow identified above and the treatment records that you do maintain lack the dosage administered, the route of administration, the identity of the person administering the drug, and withdrawal times.

3. You lack an adequate inventory system for determining the quantities of drugs used to medicate your livestock.

You also caused the drug Penicillin G Procaine to become adulterated within the meaning of section 501(a)(5) of the Act [21 U.S.C. 351(a)(5)) when you failed to use the drug in conformance with the approved labeling. The use of a drug in an animal in a manner that is not in accordance with the approved labeling is only permitted if it is in compliance with sections 512(a)(4) and 512(a)(5) of the Act and 21 CFR Part 530, including the requirement that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. You used this drug without the oversight of a veterinarian causing the drug to be unsafe under section 512(a) of the Act [21 U.S.C. 360b(a)] and adulterated within the meaning of section 501(a)(5) of the Act [21 U.S.C. 351(a)(5)].

The above is not intended to be an all-inclusive list of violations. 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 such as seizure and/or injunction. You should also be aware that it is not necessary for you to have personally shipped an animal into interstate commerce to be responsible for a violation of the Act. The fact that you offered an animal for sale, through a broker or auction, to a slaughterhouse that ships in interstate commerce is sufficient to hold you responsible for violations of the Act.

Within fifteen (15) days of the receipt of this letter, please advise this office of the specific steps you have taken to correct these violations and preclude their recurrence. If corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which corrections will be completed. Please include with your response copies of any documentation demonstrating that corrections have been made.

Please send your written reply to the Food and Drag Administration, Attention: Lisa M. Althar, Compliance Officer, 22201 23rd Drive SE, Bothell, WA 98021-4421. If you have any questions regarding this letter, please contact Ms. Althar at (425) 483-4940.

Sincerely,


/S/

Charles M. Breen
District Director


http://www.fda.gov/foi/warning_letters/g5444d.htm

Public Health Service
Food and Drug Administration

Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
Telephone: 303-236-3000
FAX: 303-236-3100








May 9, 2005

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Eric W. Daale
Owner/Partner
Heritage Dairy
650 Curry Road F
Clovis, NM 88101-9208

Ref. #: DEN-05--11

Dear Mr. Daale:

A tissue residue report received by the Food and Drug Administration (FDA) from the United States Department of Agriculture (USDA) reported the presence of illegal drug residues in cows owned by your firm. As a follow-up to USDA's findings, an FDA investigator conducted an inspection of your dairy operation located at 650 Curry Road F, Clovis, New Mexico, on February 7-11, 2005. The inspection 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 (the Act), [21 U.S.C. 342(a)(2)(C)(ii)] and j21 U.S.C. 342(a)(4)]. In addition, you may have caused animal drugs to become adulterated within the meaning of section 501(a)(5) of the Act, [21 U.S.C. 351(a)(5)].

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. Two dairy cows owned by your firm and sold at auction for slaughter for human food were found to contain illegal levels of drug residues by USDA testing.

On July 7, 2004, USDA, Food Safety and Inspection Service (FSIS) collected a tissue sample from a culled dairy cow sold by you at auction for slaughter for human food with ear tag #[redacted] BT tag and Brucellosis tag # [redacted]). The tissue (USDA Sample No. 450426) tested positive for the presence of penicillin residue of 0.40 parts per million (ppm) in the kidney and 0.34 ppm in the liver. A tolerance of 0.05 ppm has been established for residues of penicillin in the uncooked edible tissues of cattle, Title 21, Code of Federal Regulations (CFR), Part 556.510 (21 CFR 556.510). The presence of this drug in uncooked edible tissue from this animal, in amounts exceeding the tolerance set out in 21 CFR 556.510, causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act.

Similarly, on September 14, 2004, USDA, FSIS collected a tissue sample from a culled dairy cow sold by you at auction for slaughter for human food with ear tag #[redacted] and Brucellosis tag #[redacted]. The tissue (USDA Sample No. 450439) tested positive for the presence of penicillin residue of 0.29 parts per million (ppm) in the kidney and 0.12 pprn in the liver. As noted above, a tolerance of 0.05 ppm has been established for residues of penicillin in the uncooked edible tissues of cattle (21 CFR 556.510), and the presence of this drug in uncooked edible tissue from this animal, in amounts exceeding the tolerance, causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act.

Our investigation also found that you hold animals under conditions that could allow medicated animals bearing potentially harmful drug residues 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 appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. 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 which are so inadequate, that medicated animals bearing possibly harmful drug residues are likely to enter the food supply.

In addition, you are adulterating the drug penicillin that your firm uses on dairy cows when you fail to use the drug in conformance with its approved labeling. Your practice of administering this drug for a longer period than specified in the drug's labeling and in amounts exceeding the drug's indicated dosage causes the drug to be unsafe for use within the meaning of section 512(a) of the Act and thus adulterated under section 501(a)(5) of the Act.

This 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 operation 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, such as seizure and/or injunction. You should be aware that it is not necessary for you to have personally shipped an animal in interstate commerce to be responsible for a violation of the Act. The fact that you offered an animal for sale, thru a broker or auction, to a slaughterhouse that ships in interstate commerce is sufficient to hold you responsible for violations of the Act.

You should notify this office, in writing, within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to correct these violations and preclude their recurrence . If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the timeframe within which the corrections will be completed. Please include with your response copies of any documentation demonstrating that corrections have been made. Your response should be sent to: William H. Sherer, Compliance Officer, U.S. Food and Drug Administration, P.O. Box 25087, Denver, Colorado, 80225-0087. You may reach Mr. Sherer at (303) 236-3051 if you have any questions about this matter.

Sincerely,

/S/


B. Belinda Collins
District Director


http://www.fda.gov/foi/warning_letters/g5325d.htm



THE LATEST HERE;



http://www.accessdata.fda.gov/scripts/wlcfm/subject.cfm?FL=I


On or about October 26, 2001, you sold a cow (identified as cow #485 in your

records) for slaughter as human food to [redacted]. USDA analysis of
tissue samples collected from that animal identified the presence of
penicillin at 1.11 ppm in the kidney. A tolerance of 0.05 ppm has been
established for residues of penicillin in the edible tissues of cattle
(Title 21, Code of Federal Regulations, Part 556.510). The presence of
this drug in edible tissue from this animal causes the food to be
adulterated within the meaning of Section 402(a)(2)(C)(ii) of the Act.

Our investigation also found that you hold animals under conditions that
are so inadequate that 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 appropriate
periods of time to permit depletion of potentially hazardous residues of
drugs from edible tissues. As noted in form FDA-483 issued to you on
January 2, 2002, you did not follow the labeled withdrawal time of 10
days after treating your cow #485 with penicillin. Foods from animals
held under such conditions are adulterated within the meaning of Section
402(a)(4) of the Act.

You are adulterating the penicillin drug that your firm uses on cows
within the meaning of Section 50 1 (a)(5) when you fail to use the drug
in conformance with its approved labeling. Your use of the drug without
following the labeled withdrawal period causes the drug to be unsafe to use.

snip...

http://www.fda.gov/foi/warning_letters/g30



DEPARTMENT OF HEALTH AND HUMAN SERVICE

Public Health Service

Food and Drug Administration
Kansas City District
Southwest Region
11630 West 80 Street
P.O. Box 15905
Lenexa. Kansas 662855905
Telephone: (913) 752-2100

CERTIFIED MAIL
RETURN RECEIPT REQUESTED
May 8, 2002
WARNING LETTER
KAN #2002-06

Brent J. Rus, Owner
Brent Rus Farm
3330 & 3287 Dogwood Avenue
Rock Valley, IA 51247

Dear Mr. Rus:

A tissue residue report received by the Food and Drug Administration (FDA) from the United States Department of Agriculture (USDA) reported the presence of illegal drug residues in a cow that originated from your cattle raising operation. As a follow-up to USDA?s finding, our investigator performed an inspection of your operation located in Rock Valley, Iowa, on March 21 to 25, 2002. The inspection revealed serious violations of Section 402 and 501 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. On/about February 12, 2002, you offered a cow, identified with back tag number 41 MN 4358 (USDA laboratory report number 442053) for slaughter as human food. USDA analysis of tissue samples collected from that cow identified the presence of the drugs penicillin in the kidney at 0.55 parts per million (ppm), gentamicin in the kidney at 6.09 ppm, and sulfamethazine in the muscle at 6.22 ppm. Presently, the tolerance level for penicillin and sulfamethazine in the edible tissues of cattle is 0.05 ppm and 0.1 ppm respectively. There is no tolerance for gentamicin in the edible tissues of cattle.

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 the 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, you lack an adequate system for assuring that animals have been treated only with drugs which have been approved for use in those species; for assuring that drugs are used in a manner not contrary to the directions contained in the labeling; and for assuring that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues.

You are adulterating the drugs penicillin, gentamicin and sulfamethazine that you use on cattle within the meaning of Section 501(a)((5) when you fail to use the drugs in conformance with its approved labeling. Your use of the drugs in a species for which it is not approved, at a higher than labeled dosage, or without following labeled withdrawal periods, causes the drugs to be unsafe to use.

This 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 operation 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 such as seizure and/or injunction.

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

You should notify our office in writing, within fifteen (15) working days of the receipt of this letter, of the specific steps you have taken to correct these violations and preclude their recurrence. If corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which corrections will be completed. Your response should address each discrepancy brought to your attention during the inspection and in this letter, and should include copies of any documentation demonstrating that corrections have been made. Please direct your reply to Clarence R. Pendleton, Compliance Officer, at the address listed above.

Sincerely,

Charles W. Sedgwick

District Director

Kansas City District

=====

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



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



this was only a quick search, many more there.



HUMAN CONCERN;





April 2004
The Problem of Antibiotic Resistance
Overview

The triumph of antibiotics over disease-causing bacteria is one of modern medicine's greatest success stories. Since these drugs first became widely used in the World War II era, they have saved countless lives and blunted serious complications of many feared diseases and infections. After more than 50 years of widespread use, however, many antibiotics don't pack the same punch they once did.

Over time, some bacteria have developed ways to outwit the effects of antibiotics. Widespread use of antibiotics is thought to have spurred evolutionary changes in bacteria that allow them to survive these powerful drugs. While antibiotic resistance benefits the microbes, it presents humans with two big problems: it makes it more difficult to purge infections from the body; and it heightens the risk of acquiring infections in a hospital.

Diseases such as tuberculosis, gonorrhea, malaria, and childhood ear infections are now more difficult to treat than they were decades ago. Drug resistance is an especially difficult problem for hospitals because they harbor critically ill patients who are more vulnerable to infections than the general population and therefore require more antibiotics. Heavy use of antibiotics in these patients hastens the mutations in bacteria that bring about drug resistance. Unfortunately, this worsens the problem by producing bacteria with greater ability to survive even our strongest antibiotics. These even stronger drug-resistant bacteria continue to prey on vulnerable hospital patients.

To help curb this problem, the Centers for Disease Control and Prevention (CDC) provides hospitals with prevention strategies and educational materials to reduce antimicrobial resistance in health care settings. According to CDC statistics

Nearly two million patients in the United States get an infection in the hospital each year
Of those patients, about 90,000 die each year as a result of their infection-up from 13,300 patient deaths in 1992
More than 70 percent of the bacteria that cause hospital-acquired infections are resistant to at least one of the drugs most commonly used to treat them
Persons infected with drug-resistant organisms are more likely to have longer hospital stays and require treatment with second or third choice drugs that may be less effective, more toxic, and more expensive
In short, antimicrobial resistance is driving up health care costs, increasing the severity of disease, and increasing the death rates from certain infections.

Environment Forces Evolutionary Change

A key factor in the development of antibiotic resistance is the ability of infectious organisms to adapt quickly to new environmental conditions. Bacteria are single-celled creatures that, compared with higher life forms, have small numbers of genes. Therefore, even a single random gene mutation can greatly affect their ability to cause disease. And because most microbes reproduce by dividing every few hours, bacteria can evolve rapidly. A mutation that helps a microbe survive exposure to an antibiotic drug will quickly become dominant throughout the microbial population. Microbes also often acquire genes, including those that code for resistance, from each other.

The advantage microbes gain from their innate adaptability is augmented by the widespread and sometimes inappropriate use of antibiotics. A physician, wishing to placate an insistent patient ill with a cold or other viral condition, sometimes inappropriately prescribes antibiotics. Also when a patient does not finish taking a prescription for antibiotics, drug-resistant microbes not killed in the first days of treatment can proliferate. Hospitals also provide a fertile environment for drug-resistant germs as close contact among sick patients and extensive use of antibiotics force bacteria to develop resistance. Another controversial practice that some believe promotes drug resistance is adding antibiotics to agricultural feed.

A Growing Problem

For all these reasons, antibiotic resistance has been a problem for nearly as long as we've been using antibiotics. Not long after the introduction of penicillin, a bacterium known as Staphylococcus aureus began developing penicillin-resistant strains. Today, antibiotic-resistant strains of S. aureus bacteria as well as various enterococci-bacteria that colonize the intestines-are common and pose a global health problem in hospitals. More and more hospital-acquired infections are resistant to the most powerful antibiotics available, methicillin and vancomycin. These drugs are reserved to treat only the most intractable infections in order to slow development of resistance to them.

There are several signs that the problem is increasing:

In 2003, epidemiologists reported in The New England Journal of Medicine that 5 to 10 percent of patients admitted to hospitals acquire an infection during their stay, and that the risk for a hospital-acquired infection has risen steadily in recent decades.
Strains of S. aureus resistant to methicillin are endemic in hospitals and are increasing in non-hospital settings such as locker rooms. Since September 2000, outbreaks of methicillin-resistant S. aureus infections have been reported among high school football players and wrestlers in California, Indiana, and Pennsylvania, according to the CDC.
The first S. aureus infections resistant to vancomycin emerged in the United States in 2002, presenting physicians and patients with a serious problem. In July 2002, the CDC reported that a Michigan patient with diabetes, vascular disease, and chronic kidney failure had developed the first S. aureus infection completely resistant to vancomycin. A similar case was reported in Pennsylvania in September 2002.
Increasing reliance on vancomycin has led to the emergence of vancomycin-resistant enterococci infections. Prior to 1989, no U.S. hospital had reported any vancomycin resistant enterococci, but over the next decade, such microbes have become common in U.S. hospitals, according to CDC.
A 2003 study in The New England Journal of Medicine found that the incidence of blood and tissue infections known as sepsis almost tripled from 1979 to 2000.
NIAID Research

The National Institute of Allergy and Infectious Diseases (NIAID), part of the Department of Health and Human Services' National Institutes of Health (NIH), funds research, drug screening, and clinical trials to combat the problem of antimicrobial resistance. It manages a research portfolio of grants specifically aimed at the problem of antibiotic resistance among common bacteria responsible for hospital-acquired infections. These grants fund studies on the basic biology of resistant organisms; applied research on new diagnostic techniques, therapies, and preventive measures; as well as studies of how bacteria develop and share resistance genes. Other NIAID-funded research projects seek to identify natural antimicrobial peptides (small pieces of protein molecules) that could help stave off drug-resistant infections.

NIAID also funds the Network on Antimicrobial Resistance in Staphylococcus aureus (NARSA), a multidisciplinary international cadre of basic scientists, clinical microbiologists, and clinical investigators focused on combating drug-resistant S. aureus and related staphylococcal bacterial infections. The network maintains a repository of drug-resistant staph strains that scientists can request for use in their research. It also provides an Internet site with scientific presentations and a discussion forum to promote communication between researchers. The NARSA Web site is available at http://www.narsa.net.

NIAID also supports a number of networks for clinical trials with the capacity to assess new antimicrobial drugs and vaccines against other drug-resistant infections. The AIDS Clinical Trials groups can evaluate drugs that combat the problem of the HIV virus developing resistance to standard antiretroviral treatments. The Bacteriology and Mycology Study Group, a network of academic and private research institutes, conducts clinical trials for improved treatments for fungal infections, particularly in people with weakened immune systems. In a similar fashion, the Collaborative Antiviral Study Group, made up of researchers at approximately 50 institutions, evaluates experimental therapies for viral infections. The Vaccine and Treatment Evaluation Units are a network of seven U.S. institutions that conduct clinical research on vaccines and therapeutics to speed development of new vaccines and therapies.

More details on these and other related projects can be found on the NIAID Web site at http://www.niaid.nih.gov/dmid/antimicrob.

Other research projects-at NIH or funded by other components of NIH-are seeking new, molecular-level knowledge on the interactions of microbes and human cells as well as the tricks microbes use to outwit antibiotics. Another avenue of research is sleuthing the genomes of drug-resistant bacteria for vulnerabilities that could be attacked with new or existing drugs.

Antimicrobial Advances and Activities

NIAID-funded research grants and activities are yielding results that will help public health officials hold the line in our fight against drug-resistant microbes. For example

NIAID-funded researchers at the University of California Berkeley have documented the mechanics of how E. coli bacteria use pumps in the thin space between their membranes to expel antibiotic drugs. Their results, reported in the Journal of Bacteriology, serve as a model for how these molecular pumps work in bacteria responsible for hospital-acquired infections.
NIAID grantees at the Washington University School of Medicine in St. Louis have uncovered new information about how bacteria that cause urinary tract infections manufacture hair-like fibers to cling to the lining of the bladder. Their findings could lead to new drugs that would treat urinary tract infections by blocking formation of these protein fibers. Approximately half of all women experience urinary tract infections, and 20 to 40 percent of those will develop recurrent infections. The results were reported in the journal Cell.
An NIAID-funded project at The Institute for Genomic Research recently discovered that small pieces of DNA that can jump between chromosomes or organisms helped a strain of E. faecalis bacteria develop resistance to vancomycin. The researchers found that these "mobile elements" of DNA appear to contain a newly identified vancomycin resistance segment carrying vancomycin resistance genes. These results were published in the journal Science.
Partnerships and Interagency Collaborations

In addition to sponsoring research, NIAID co-chairs the Federal government's Interagency Task Force on Antimicrobial Resistance. This task force is made up of representatives from NIAID, CDC, the Food and Drug Administration, the Agency for Healthcare Research and Quality, the Department of Agriculture, the Department of Defense, the Department of Veterans Affairs, the Environmental Protection Agency, the Center for Medicaid and Medicare Services, and the Health Resources and Services Administration. The Task Force is working on implementing an antimicrobial resistance action plan that reflects a broad consensus of theses agencies with input from a variety of constituents and collaborators. The plan is available online at http://www.cdc.gov/drugresistance/actionplan/index.htm.

NIAID also co-sponsors the Annual Conference on Antimicrobial Resistance with the Infectious Disease Society of America and other government and not-for-profit agencies. The conference updates attendees on the science, prevention, and control of antimicrobial resistance and provides a forum for discussion of new methods of treatment and control.

Related Information

Other federal agencies are involved in combating the problem of drug-resistant microbes. See the links below for more information.

Centers for Disease Control and Prevention
http://www.cdc.gov/drugresistance/community/

Food and Drug Administration
http://www.fda.gov/oc/opacom/hottopics/anti_resist.html

National Library of Medicine Medline database
http://www.nlm.nih.gov/medlineplus/antibiotics.html

Public Health Action Plan to Combat Antimicrobial Resistance
http://www.cdc.gov/drugresistance/actionplan/index.htm


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

NIAID is a component of the National Institutes of Health (NIH), which is an agency of the Department of Health and Human Services. NIAID supports basic and applied research to prevent, diagnose, and treat infectious and immune-mediated illnesses, including HIV/AIDS and other sexually transmitted diseases, illness from potential agents of bioterrorism, tuberculosis, malaria, autoimmune disorders, asthma and allergies.

News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.

Prepared by:
Office of Communications and Public Liaison
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Bethesda, MD 20892

U.S. Department of Health and Human Services

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



Health Care Topics: Antibiotic Resistance

What is it?

Antibiotic resistance is a worldwide public health problem that continues to grow. It occurs when strains of bacteria in the human body become resistant to antibiotics due to improper use and abuse of antibiotics.

How many people does it affect?

In hospitals, 190 million doses of antibiotics are administered each day. Among non-hospitalized patients, more than 133 million courses of antibiotics are prescribed by doctors each year. It is estimated that 50 percent of these latter prescriptions are unnecessary since they are being prescribed for colds, coughs and other viral infections.

Common causes

Many individuals either expect or ask their physicians to prescribe antibiotics when they feel sick or have a common cold. Patients should understand, though, that antibiotics are intended to treat bacterial infections, not viral infections. And many times a common cold is a viral infection.

The only true way to know if your cold or sickness is a bacterial infection and whether it should be treated with antibiotics is for your physician to test it. If you have a sore throat your physician should take a throat culture test. If the the test results indicate that a bacterial infection is present, then antibiotics should be prescribed to treat the infection. There is no sure way of knowing whether a cold or sickness is a bacterial infection without a test.

The improper use and abuse of antibiotics has led to the development of antibiotic resistance. The most common misuse and abuse of antibiotics are:

Physicians prescribing antibiotics for viral infections
Not finishing the full dosage of the antibiotic. When an antibiotic prescription is not finished (even leaving one or two pills), it leaves some bacteria alive and "resistant" to future antibiotic treatment.
How can it be prevented?

Both physicians and patients have a role to play in decreasing the misuse of antibiotics. Antibiotics should only be prescribed when a test (such as a throat culture) shows that there is a bacterial infection present. Antibiotics are not effective in fighting a viral infection. Even so, patients often demand that their physicians prescribe antibiotics when they are not needed. Taking antibiotics when you have a viral infection not only wastes your time and money, but also contributes to increasing antibiotic resistance.

Patients should ask their doctor if they have a viral or bacterial infection and which tests have been done to prove this. Physicians too, must change their prescribing practices and only prescribe antibiotics for their patients when a bacterial infection is present.

Downloadable Brochures

Download a printable brochure containing the information on this page.

Download a brochure from the U.S. Food and Drug Administration (FDA) titled ""Preserve A Treasure: Know When Antibiotics Work."



http://www.nlm.nih.gov/cgi/medlineplus/leavemedplus.pl?theURL=http%3A%2F%2Fwww%2Edoctorsforadults%2Ecom%2Ftopics%2Fdfa%5Fanti%2Ehtm



AFTER reading all these warning letters of antibiotics that are
going into animals for human consumption that are so diseased
they must be given massive amounts of atibiotics just to get them
to slaughter, it's no damn wonder we are all not becoming
resistant to these drugs. IT just does not take a PhD to figure
this out. ...


Our investigation also found that you hold animals under conditions
which may allow diseased animals and/or medicated animals bearing
potentially harmful drug residues to enter the food supply. For example:

*

You do not maintain medication/treatment records identify the
animal, the date of treatment the drug used, dosage administered,
and the drug withdrawal times.

*

You do not have a system in effect for the review of treatment
records to assure that drugs have been used as directed in the
labeling and that the appropriate withdrawal times have been
observed.

*

Terramycin (Oxytetracycline HCl) observed in the drug storage are
on your farm, and used in the treatment of cattle, was past the
expiration date of April 2001.

An FDA 483, Inspectional Observations, was issued to you at the
conclusion of the inspection listing the objectionable conditions
observed during the inspection.

snip...

http://www.fda.gov/foi/warning_letters/g3786d.htm

MORE HERE;

http://www.accessdata.fda.gov/scripts/wlcfm/subject.cfm?FL=E

another dandy one;

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

http://www.fda.gov/foi/warning_letters/g3964d.htm

MORE HERE;

http://www.accessdata.fda.gov/scripts/wlcfm/subject.cfm?FL=D

FEI: 3004125694

04-BLT-11

February 3, 2004

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Ralph L. Buckel, DVM, Co-owner and Gary R. Hash DVM, Co-Owner
Chestertown Animal Hospital
10530 Augustine Herman Highway
Chestertown, Maryland 21620

Dear Drs. Buckel and Hash,

The Food and Drug Administration (FDA) conducted an inspection at your
veterinary clinic located at Chester-town Animal Hospital, 10530
Augustine Herman Highway, Chester-town, Maryland, on August 20 and 27,
2003. The inspection was initiated in response to a United States
Department of Agriculture (USDA) report of an illegal gentamicin residue
in a bob veal calf offered for sale and slaughter for human food by
[redacted], a dairy producer located in Cordova, Maryland [redacted].
Chestertown Animal Hospital has performed veterinary work for this farm.

Our inspection found that Chester-town Animal Hospital prescribed,
compounded, and dispensed gentamicin and combinations of gentamicin with
other antibiotics for the treatment of bacterial infections in cows with
labeling specifying a 30-day meat withdrawal time. Since gentamicin
injection is not approved for use in cows, its extralabel use must
comply with FDAs regulations for extralabel drug use in animals, Title
21, Code of Federal Regulation (CFR), Part 530. Among the requirements
is that the veterinarian must establish a substantially extended
withdrawal period that is supported by appropriate scientific
information (21 CFR 530.20(a)(2)(ii)). However, the withdrawal period
you have established for the extralabel use of the gentamicin drug
products in cows is not supported by appropriate scientific information.
According to veterinary literature, no withdrawal period has been
scientifically established for gentamicin for use in cattle, and the
Food Animal Residue Avoidance Databank (FARAD) advises that a minimum
pre-slaughter withdrawal period of eighteen months or more be established.

We note that there have been two recent residue violations involving the
use of gentamicin at [redacted]. In one, on or about January 24, 2003,
the dairy farm sold a bob veal calf for slaughter s identified the
presence of 0.65 parts per million (ppm) of gentamicin in liver tissue
samples. This residue level is illegal since there is no established
tolerance for gentamicin in cattle. Our inspection revealed that you had
prescribed and dispensed the combination drug Gentamast
(penicillin/gentamicin) for the treatment of a dam and that this calf
received milk from the dam. In the other, [redacted] sold a cow for
slaughter on or about June 7, 2002, and USDA analysis identified the
presence of 0.61 ppm of gentamicin in kidney tissue. An investigation
revealed that Chestertown Animal Hospital dispensed Gentamast for the
treatment of that cow.

This letter may not list all the deviations at your facility. As
licensed veterinarians, you are responsible for ensuring that all drugs
you prescribe and administer comply with all requirements of the Food,
Drug, and Cosmetic Act (the Act) and its implementing regulations.

You should take prompt action to correct these violations and to
establish procedures to prevent their recurrence. Failure to do so may
result in regulatory action without further notice. These actions
include, but are not limited to, seizure and/or injunction.

Please notify this office in writing, within fifteen (15) working days
of receipt of this letter, of the specific steps you have taken to
correct these 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 corrections will be completed.
Your response should address each discrepancy brought to your attention
during the investigation and in this letter, and should include copies
of any documentation demonstrating that corrections have been made.
Please direct your reply to Ms. Vinetta Howard-King, Compliance Officer,
U.S. Food and Drug Administration, 6000 Metro Drive, Suite 101,
Baltimore, Maryland 21215.

Sincerely,

/S/

Lee Bowers,
District Director
Baltimore District

http://www.fda.gov/foi/warning_letters/g4525d.htm

VIA FEDERAL EXPRESS

June 29, 2004

Duaine E. Walker, Owner
Kenneth D. Walker, Owner
Walker Farms
3093 Anderson Avenue NE
Minerva, OH 44657

WARNING LETTER CIN-04-22024

Dear Mr. Walker:

An inspection of your dairy farm located in Minerva, Ohio by Food and
Drug Administration (FDA) Investigator Mishelle L. Harriger from
4/30/2004 - 5/6/2004 confirmed that you offered an animal for sale as
human food in violation of the Federal Food, Drug, and Cosmetic Act (the
Act). The animal (a bob veal calf) was adulterated food within the
meaning of sections 402(a)(2)(C)(ii) and 402(a)(4) of the ACT.

The United States Department of Agriculture (USDA)/Food Safety
Inspection Service (FSIS) analyses of tissues collected from the animal
disclosed the presence of the following drugs:

Animal ID Drug Tissue Level Tolerance
Back Tag 262 Neomycin Muscle detected None Established
Neomycin Kidney 88.24ppm None Established
Penicillin Kidney 0.06ppm None Established

Tolerance levels for residues of new animal drugs are found in Title 21,
Code of Federal Regulations (CFR), Part 556. There are no established
tolerances for either Neomycin or Penicillin in bob veal calves. As
such, the presence of these drugs in the edible tissues of this animal
causes the food to be adulterated within the meaning of section
402(a)(2)(C)(ii) of the Act.

The investigation also found that you hold animals under conditions that
could allow medicated animals, bearing potentially harmful drug
residues, to enter the food supply. For example:

* You do not maintain written records demonstrating that animals
that have received medications have been withheld from milk
production or withheld from slaughter for the number of days
indicated on the drugs label.
* You do not segregate animals that have been treated with
medications from the rest of the herd.
* You do not have a record of the medications that you purchase or use.

Food from animals held under such conditions is adulterated within the
meaning of section 402(a)(4) of the Act.

We also note that the [redacted] Auction has on file a certificate (or
guarantee ) from your firm stating that the animals that you sell there
do not contain any illegal drug residues. If you continue to medicate
animals without maintaining the records and procedures listed above, you
may be giving a false guarantee. Giving a false guarantee is prohibited
by section 301(h) of the Act.

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

The violations listed above are not intended to be an all-inclusive
list. It is your responsibility to assure that your operations are in
compliance with the law.

You should be aware that it is not necessary for you to have personally
shipped an 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 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 notify this office in writing within 15 working days of the
steps you have taken to bring your firm into compliance with the law.
Your response should include each step being 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 reply should be addressed to Food and Drug Administration, 6751
Steger Drive, Cincinnati, OH 45237-3097, Attention: Stephen J. Rabe,
Compliance Officer.

Sincerely,

/s/

Carol A. Heppe
District Director
Cincinnati District Office

http://www.fda.gov/foi/warning_letters/g4814d.htm

HERE is another page of these bad boys;

http://www.accessdata.fda.gov/scripts/wlcfm/subject.cfm?FL=I

ANOTHER dandy one;

On or about January 3, 2001, you sold a dairy cow identified with back
tag #7639 and listed as USDA Case #8-0375-00, Form #407287, for
slaughter as human food to [redacted]. USDA analysis of tissue samples
collected from that animal identified the presence of tilmicosin in the
liver at 25.70 parts per million (ppm). A tolerance of 1.20 ppm has been
established for residues of tilmicosin in the liver tissue of cattle
(Title 21 Code of Federal Regulations 556.735). USDA analysis also
identified 1.60 ppm in the muscle and 29.90 ppm in the kidney. There is
no established tolerance for tilmicosin in these edible tissues.

On or about June 12, 2001, you sold a dairy cow identified with back tag
#3431 and listed as USDA Case #8-0375-00, Form #407296, for slaughter as
human food to [redacted]. USDA analysis of tissue samples collected from
that animal identified the presence of penicillin in the liver at 00.29
ppm and in the kidney at 0.33 ppm. A tolerance of 0.05 ppm has been
established for residues of penicillin in edible tissues of cattle
(Title 21 Code of Federal Regulations 556.510).

On or about February 5, 2002, you sold a dairy cow identified with back
tag #5977 and listed as USDA Case #8-0375-00, Form #439522, for
slaughter as human food to [redacted]. USDA analysis of tissue samples
collected from that animal identified the presence of penicillin in the
liver at 00.47 ppm and in the kidney at 1.19 ppm. As stated above, a
tolerance of 0.05 ppm has been established for residues of penicillin in
edible tissues of cattle (Title 21 Code of Federal Regulations 556.510).

http://www.fda.gov/foi/warning_letters/g3279d.htm

another page full ;

http://www.accessdata.fda.gov/scripts/wlcfm/subject.cfm?FL=N

The inspection confirmed that you participated in a verbal agreement in
the capacity of the consulting/prescribing veterinarian for drugs
compounded by [redacted] from about November 1, 2001, through November,
2002. In the agreement, established by yourself and [redacted] Salesman
of [redacted] you provide veterinary services to farm and ranch clients
within a [redacted] mile radius of your firm by prescribing veterinary
drugs compounded by [redacted] During the time of this agreement,
dispensing records maintained by [redacted] identify you as the
authorizing/prescribing veterinarian for the following compounded drugs:

dipyrone fluphanazine*
gentamycin sulfate* fluoxetine*
Enrofloxacin* methylprednisolone
Ivermectin* ketoprofen
phenylbutazone flunixin

The drugs identified with the asterisks denote drugs that are prohibited
for extra label use in food producing animals under Title 21 CFR 530.41.

Records provided from your veterinary files document the following
example of your activities during your agreement with [redacted]

On 4/16/02, you authorized [redacted]s dispensing of the compounded
injectable prescription drugs, enrofloxacin (Baytril), ivomectin
(Ivermectin), and flunixine (Banamine) to [redacted] This
authorization was made without you establishing a valid VCPR with
the firm. Your veterinary files do not include documentation that
the drugs were identified particular species of animals to be
treated; diagnosis of a specific disease(s); dosage and time period
for treatment; or route of administration, cautionary statements, or
a withdrawal time(s) established for animals that may be marketed
for consumption as human food.

FDAs investigation found that [redacted] used the above prescription
veterinary drugs in the treatment of cattle. Ivermectin 2% sterile
injection present at [redacted] was labeled with a withdrawal time that
you, as the prescribing veterinarian, had taken no part in establishing.
Additionally, the enrofloxacin injection was labeled in part ** FOR USE
AS DIRECTED * Dr. THONI, ROB **. You confirmed, you have no records
establishing the need for these compounded drug products. In fact, FDA
approved versions of these drugs are available in the marketplace.

Our inspection documented dispensing by [redacted] and various RX orders
authorized by Dr. Rob Thoni, DVM as veterinarian of record during the
time of your agreement, of a compounded equine antibiotic, Gentamycin
100MG/ML-500ML injectable drug to [redacted] and other livestock
producers/growers in [redacted] You were unable to provide
patient/client records to support a VCPR with these operations.
Investigations found the drug was being used for medical treatment of
starter calves. These producers/growers include:

[redacted] on 9/10/02, RX [redacted]
[redacted] on 9/23/02, RX [redacted]
[redacted] on 10/15/02, RX [redacted]

I have attached a copy of the Form FDA-483, Inspectional Observations
issued by the investigators and discussed with you at the completion of
the inspection on February 5, 2003.

By prescribing, and authorizing the dispensing of the above listed drugs
by [redacted] you as the veterinarian accepting responsibility for the
medical treatment of animals, have caused the compounding of unapproved
new animal drugs, as well as, the shipment of those drugs in interstate
commerce. These drugs were compounded, with the use of bulk active
pharmaceutical ingredients (APIs), for administration in food producing
animals and horses. [redacted] holds no approval of applications for the
above listed drugs as required pursuant to Section 512(a)(1)(A) of the
FD & C Act. The drugs are deemed unsafe, and therefore, are adulterated
within the meaning of Section 501(a)(5) of the FD & C Act.

As a licensed prescribing veterinarian, you hold the responsibility to
know and understand federal and state laws that apply to you and your
veterinary practice. The only legal compounding of animal drugs is
provided for under the Animal Medicinal Drug use Clarification Act of
1994 and its implementing regulations at 21 Code of Federal Regulations
(CFR) Part 530 - Extralabel Drug Use in Animals. 21 CFR 530.13 provides,
for a veterinarian or pharmacist to compound animal drugs on the lawful
written order of a licensed veterinarian only if certain conditions are
met. The conditions include the requirement that the compounding be
within the context of a valid VCPR, and that the compounding is
conducted with the use of already approved drug products. Compounding,
using bulk active pharmaceutical ingredients is not permitted.

You should take prompt action to correct the violations encountered and
assure that your future orders for prescription veterinary drugs, and
the authorized dispensing of those drugs for/to animals of your
clientele, are in fact legal products and their administration follows
all required conditions for use under the FD & C Act and regulations.
Failure to correct the conditions of your veterinary practice and to
establish procedures whereby such conditions do not recur may result in
further investigations and possible Agency actions against regulated
products and or responsible individuals.

You should notify this office in writing within 15 working days of the
steps you have taken to bring your firm into compliance with the law.
Your response should include each step taken, or to be taken, to correct
the violations and prevent their recurrence. Please include copies of
any available documentation demonstrating corrections have been made.
You should address your response to the attention of James R. Lahar,
Compliance Officer at the above letterhead address.

Sincerely yours,

/s/

Michael A. Chappell
Dallas District Director

http://www.fda.gov/foi/warning_letters/g4798d.htm

November 25, 2003

Ref: 2004-DAL-WL- 08

WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Jack R. Munn, R.Ph., President
Medical Park Pharmacy
9786 Skillman St.
Dallas, Texas 75243

PRODUCTS:

Albendazole
Clenbuterol
Dexamethasone
Enrofloxacin
lvermectin
Phenylbutazone Powder
Levamisole Hcl
Sulfadiazine Sodium
Cisapride

Dear Mr. Munn:

An inspection of your veterinary drug compounding operation, located at
the above address, conducted by an investigator of the Food and Drug
Administration (FDA) from this office on July 28/August 6, 2003,
disclosed significant violations of the Federal Food, Drug, and Cosmetic
Act (the Act). The investigator was accompanied by Mr. Cy Weich, R.Ph.,
Chief Compliance Officer of the Texas State Board of Pharmacy (TSBP).

Our investigation has determined that Medical Park Pharmacy is exceeding
the regulations under which a compounding pharmacy may compound
veterinary drugs. Our findings include, but may not be limited to:

The use of bulk active pharmaceutical ingredients (APls) under
circumstances that create public health concerns. Your compounded drugs
are processed using bulk APls. When used in food animals, these drugs
present particular safety concerns because of the possibility that
unsafe drug residues could occur in edible tissues. Your compounded
drugs are essentially duplicates of FDA approved animal drug products
available on the market. Additionally, some compounded animal drugs,
such as cisapride, have been withdrawn from the market for human use for
safety reasons

* Distribution of compounded animal drugs labeled! FOR VETERINARY
CLINIC USE, and otherwise lacking directions for patient specific use.
The prescription drugs distributed to individuals, farms, ranches, feed
stores, veterinarians, and animal clinics by your firm often fail to
record critical information necessary to establish treatment for a
specific species, or identification of the animal(s) to receive
treatment. Prescription drug labeling frequently fails to indicate
directions for use, and instead indicates See Veterinary References for
Dosage for Species and Organism. Drugs compounded for food animals do
not bear a withdrawal time established by a State licensed veterinarian;
instead withdrawal times printed on your product labels are provided by
your firm, and are not backed by scientific data supporting the
withdrawal periods indicated.

The veterinary drugs compounded and distributed by your firm are new
animal drugs within the meaning of section 201(v) of the Act (21 U.S.C.
321(v)). These animal drugs are adulterated under section 501(a)(5) of
the Act (21 U.S.C. 351(a)(5)) because they are unsafe within the meaning
of section 512 of the Act (21 U.S.C. 360b). Section 512. in part, deems
a new animal drug to be unsafe unless an approved New Animal Drug
Application (NADA) is in effect for the specific product in question.
None of the animal drugs you compound and distribute are the subject of
an approval by FDA.

The only legal compounding of animal drugs is provided under the Animal
Medicinal Drug Use Clarification Act and its implementing regulations at
21 CFR Part 530, Extralabel Drug Use in Animals. 21 CFR 530.13 allows a
veterinarian or pharmacist to compound animal drugs on the lawful
written order of a licensed veterinarian only if certain conditions are
met. The conditions include the requirement that the compounding be
within the context of a valid veterinanian-client-patient relationship
(VCPR), and that the compounding be conducted only with the use of
approved drug product & However, your firm compounded animal drugs using
bulk APIs, which is not permitted under 21 CFR 530.13(a). Moreover, some
of your animal drugs were compounded using the bulk drug substance
cisapride, which was withdrawn from the market for safety reasons. In
addition, it appears that your products were being compounded outside
the context of a valid VCPR, as required by 21 CFR 530.10(a), and that
your products were not labeled with directions for use specified by a
veterinarian, including the animal or animals in which the drug is
intended to be used,
as required by 21 CFR 530.12(c).

The above is not intended to be an all-inclusive list of violations by
your firm. It is your responsibility to ensure that your firms
operations and products are in compliance with the law and applicable
regulations. Our inspectional findings were listed on a Form FDA 483,
Inspectional Observations, which was issued and discussed with you at
the end of the inspection.

You should take prompt action to correct the noted violations, and you
should establish procedures whereby such violations do not recur.
Failure to promptly correct these violations may result in regulatory
sanctions. These sanctions include, but are not limited to, seizure
and/or injunction.

Within fifteen (15) working days of receiving this letter, you should
notify this office in writing of the specific steps you have taken to
correct the violations, including an explanation of each step being
taken to prevent the recurrence of similar violations. If corrective
action cannot be completed within fifteen (15) working days, state the
reason for the delay and the time period within which the corrections
will be completed. You may address your reply to James R. Lahar,
Compliance Officer, at the above address.

Sincerely,

/s/

Michael A. Chappell

Dallas District Director

horizonal rule

http://www.fda.gov/foi/warning_letters/g4411d.htm

Certified Mail

Return Receipt requested

Warning Letter

2003-DT-20

August 20, 2003

Mr. Patrick M. Hunter, President
H&H Feed & Grain, Inc.
14096 Portege Road
Vicksburg, Michigan 48007

Dear Mr. Hunter:

An investigation of your feed mill located at 14096 Portage Road,
Vicksburg, Michigan, conducted by a Food and Drug Administretion (FDA)
investigatar on February 6 and 14, 2003, found significant deviations
from the mquirementa relating to animal drugs and medicated feeds,
inctudfng the Veterinary Feed Directive (VFD) regulations (Title 21,
Code of Federal Regulations, section 556.6). Such deviations caused an
animal drug to be adulterated under Section 501 (a)(5) of the Federal
Food, Drug, and
Cosmetic Act (the Act) and misbranded under Section 504(a)(5) of the
Act. The deviations also caused animal feed to be adulterated under
Section 501 (a)(6) of the Act and misbranded under Section 604(b) of the
Act.

Our investigation found your feed mill to be manufacturing complete
medicated swine feeds containing the Veterinary Feed Directive (VFD)
drug Tilmicosin in a manner that does not conform to the requirements of
the Act and the agencys regulations.
The deviations include:

(1) Your feed mill failed to use the Type E medicated feed containing
Tumicosin in accordance with labeled mixing directions, which resulted
in sub-potent feeds. This caused it to be unsafe under Section 512(a) of
ths Act and adulterated within the meaning of Section 501(a)(6) of the Act.

(2) Your feed mill failed to follow the products conditions of use by
not feeding continuously for a 21 day period. This caused the drug to be
unsafe under Section 512(a) of the Act and adulterated within the
meaning of Section 501(a)(5) of the Act.

(3) Your feed mill manufactured Type C medicated feed containing
Tilmicosin that failed to contain labeling conforming to the animal
drugs approval.

For example, it did not contain ingredient statements, cautionary
statements, or withdrawal information. This caused the medicated feed to
be unsafe under Section 512(a) of the Act and adulterated within the
meaning of Section 501 (a)(6) of the Act.

(4) The VFD medicated feed labeling did not contain the cautionary
statement: Caution: Federal law limits this dnrg to use under the
professional supervision of a of a licensed veterinarian. Animal feed
beating or containing this veterinary feed directive drug shall be fed
to animils only by or upon a lawful veteranary feed directive issued by
a licensed veterinarian in the course of the veterinarian's
professional practice. 21 CFR 558.6(f) requires all labeling and
advertising of VFD drugs and animal feeds containing VFD druga to
prominently and conspicuously diapiay this statement. Your failure to do
so caused the animal feed to be misbranded within the meaning of Section
504(b) of the Act.

(5) Your firm manufactured, in June, October, and November of 2002, for
its own use and for distribution, at least [redacted] batches of VFD
feeds containing Tiimicosin when no VFD was in effect. Also, in October
of 2002 and February of 2003, you manufactured complete feeds not
covered by a complete and valid VFD. For example, some VFD on file at
your firm lacked the statement required in 21 CFR 558.6 (a)(4)(xii),
Extra-label use (i.e., use of this VFD tied in a manner other than as
provided for in the VFD drug approval) is strictly prohibited. Failure
to follow the VFD requirements caused the me4icated feed to be unsafe
under Section 512(a) of the Act and adulterated within the meaning of
Section 501 (a)(6) of the Act.

(6) Your firm has been distributing feeds containing a VFD drug since
early 2002, but has not submitted a notification letter to FDAs Center
for Veterinary Medicine that you intend to distribute animal feed
ccnteining a VFD drug as required by 21 CFR 5586(d). This causes the
drug to be misbranded within the meaning of Section 504(a)(3)(C) of the Act.

The above is not intended as an ail-inclusive list of violations. As a
manufacturer of medicated and non-medicated feeds, you are responsible
for ensuring that you are in complianca with the law. You ahoutd take
prompt action to cormot these violations, and
you should establish procedures whereby such violations do not recur.
Failure to promptly correct these violations may result in regulatory
acion without further natice, such as seizure and/or injunction.

You should notify this office, in writing, within fifteen (15) working
clays of receiving this letter of ths steps you have taken to bring your
firm into compliance with the law. Your response should include an
explanation of each step bsing taken to correct the
violations and prevent their nxxrrence, If corrective action cannot be
completed within 15 working days, state the reason for the delay and the
date by which the corrections till bo completed. Include copies of any
available documentation demonstrating that
corrections have besn made.

Your response should be directed to Mr. David M. Kaszubski, Director
Compliance Branch, at the address above.

Sincerely yours,

/s/

Joann M. Givens

District Director

Detroit District Office

http://www.fda.gov/foi/warning_letters/g4251d.htm


-------- Original Message --------
Subject: Animal Proteins Prohibited in Ruminant Feed USA May
 

flounder

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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,



P.S. lot of very sick cattle pumped up with antibiotics and hormones ;

Thomas, Allan
5/06/04

Seattle District Office Illegal Drug Residue in Animal Tissue/Extralabel
Drug Use/Adulterated [PDF]

HTML:
No

Milk Source, LLC
5/05/04

Minneapolis District Office Illegal Drug Residue in Animal
Tissue/Extralabel Drug Use/Adulterated/Misbranded [PDF]

[HTML] 
No


New Horizons Dairy LLC
4/29/04

Chicago District Office Illegal Drug Residue in Animal Tissue/Extralabel
Drug Use/Adulterated [PDF]

[HTML] 
No

Daley Farms, LLP
4/23/04

Minneapolis District Office Illegal Drug Residue, Animal Tissue/Extra
Label Drug Use [PDF] 
[HTML] 
No

Lyrek Farms
4/22/04

Minneapolis District Office Illegal Drug Residue in Animal
Tissue/Extralabel Drug Use/Adulterated [PDF]

[HTML] 
No

Schultze, Frederick R.
4/07/04

New England District Office Illegal Drug Residue in Animal
Tissue/Extralabel Drug Use/Adulterated [PDF]

[HTML] 
No

Wadleigh's Falls Veterinary Clinic
4/07/04

New England District Office Illegal Drug Residue in Animal
Tissue/Extralabel Drug Use/Adulterated [PDF]

[HTML] 
No

Hillcrest Dairy, LLC
3/17/04

San Francisco District Office Illegal Drug Residue in Animal
Tissue/Extralabel Drug Use/Adulterated [PDF]

[HTML] 
No



SEEMS to me greed is fueling this as it did BSE aka 
mad cow disease... 

 
In Reply to: Groups debate US plan on antibiotics for animals and one brain dead pig farmer $$$ posted by TSS on October 4, 2002 at 2:25 pm:

RESTRICT ANTIBIOTIC USE IN ANIMALS: SCIENTISTS

A federal science panel is calling for a crackdown in the use of 
antibiotics on farm animals. The panel says antibiotic-resistant 
bacteria is developing in humans because of what we eat. 
FULL STORY:

http://cbc.ca/stories/2002/10/07/Consumers/antibiotics_021007 


RESTRICT ANTIBIOTIC USE IN ANIMALS: SCIENTISTS

http://www.accessdata.fda.gov/scripts/wlcfm/subject.cfm?FL=E




Perspectives 

Use of Antimicrobial Growth Promoters in Food Animals and Enterococcus faecium Resistance to Therapeutic Antimicrobial Drugs in Europe 
Henrik C. Wegener, Frank M. Aarestrup, Lars Bogø Jensen, Anette M. Hammerum, and Flemming Bager 
Danish Veterinary Laboratory, Copenhagen, Denmark 


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

Supplementing animal feed with antimicrobial agents to enhance growth has been common practice for more than 30 years and is estimated to constitute more than half the total antimicrobial use worldwide. The potential public health consequences of this use have been debated; however, until recently, clear evidence of a health risk was not available. Accumulating evidence now indicates that the use of the glycopeptide avoparcin as a growth promoter has created in food animals a major reservoir of Enterococcus faecium, which contains the high level glycopeptide resistance determinant vanA, located on the Tn1546 transposon. Furthermore, glycopeptide-resistant strains, as well as resistance determinants, can be transmitted from animals to humans. Two antimicrobial classes expected to provide the future therapeutic options for treatment of infections with vancomycin-resistant enterococci have analogues among the growth promoters, and a huge animal reservoir of resistant E. faecium has already been created, posing a new public health problem. 

Vancomycin-Resistant Enterococcus faecium (VRE)
In addition to being a member of the normal gut flora of nearly all warm-blooded animals (including humans), E. faecium has the ability to cause a wide range of infections, primarily serious infections in hospital patients (particularly in intensive care units). Increasing incidence of E. faecium infections has been associated with use of third-generation cephalosporins in hospitals (1). Enterococci are resistant to many antibiotics. In an increasing number of cases, vancomycin is the only treatment drug that remains effective. Because E. faecium was untreatable with practically all other antibiotics, the emergence of the first high level vancomycin-resistant E. faecium was of particular concern (2). By 1997, more than 15% of nosocomial enterococcal infections in U.S. hospitals were due to VRE (3). 

The vancomycin-resistant strain of E. faecium (VRE) contains the VanA gene cluster located at a mobile genetic element, a transposon designated Tn1546. Although other mechanisms and determinants of glycopeptide resistance have been found in E. faecium, in this article, VRE will refer to strains containing the vanA gene and Tn1546. First isolated in France in 1986, VRE were subsequently found in the United States in 1989, where they rapidly became a frequent cause of hospital infections (3). Like many other nosocomial pathogens, VRE were believed to originate and be maintained in hospitals and to have little, if any, association with the community. Nosocomial outbreaks and clonal spread in the United States supported this assumption (4). In Europe, however, even though serious incidents have occurred in some countries, VRE-associated hospital infections have not increased at the same rate and to the same proportion as in the United States (5). The first indication that the epidemiology of VRE may differ from that of other gram-positive organisms capable of causing hospital infections (e.g., methicillin-resistant Staphylococcus aureus) came from the United Kingdom, where Bates et al. (6) reported isolating VRE from pig herds as well as from the farm environment. These scientists suggested that a community source of VRE may exist. Soon afterwards, Klare et al. (7) in Germany showed that VRE could be cultured frequently from pigs, poultry, and humans in the community and suggested that VRE may be associated with the use of glycopeptides as growth promoters in food animals. 

Antimicrobial Growth Promoters
Antimicrobial growth promoters (AGPs) are antibiotics added to the feed of food animals to enhance their growth rate and production performance. The mechanism by which AGPs work is not clear. AGPs reduce normal intestinal flora (which compete with the host for nutrients) and harmful gut bacteria (which may reduce performance by causing subclinical disease). The effect on growth may be due to a combination of both fewer normal intestinal flora and fewer harmful bacteria. The class of antimicrobial drugs used and the animal species involved may determine the relative importance of each mechanism (8). The quantity used in feed varies with each antimicrobial agent. In the European Union (EU), avoparcin 20 mg/kg and 40 mg/kg was approved for different age groups of pigs and chickens; the concentration is often referred to as "subtherapeutic" (not to be confused with sub-MIC levels). The resulting concentration in the gastrointestinal tract of the animal is sufficient to inhibit the susceptible bacteria and markedly affect the composition of the bacterial gut flora (8). 

In Denmark, as well as in other countries, only a few glycopeptides have been used; for humans vancomycin and (to a lesser extent) teicoplanin have been used, and for animals avoparcin has been used exclusively as a feed additive for growth promotion. Avoparcin has not been used in animals in Sweden since 1986 because of a national prohibition of AGPs; in the United States, avoparcin was never approved because of its carcinogenic effects (9). 

Few countries have accurate data on the use of antibiotics in animals and humans. In Denmark, 24 kg of active vancomycin was used for human therapy in 1994. In comparison, 24,000 kg of active avoparcin was used as a feed additive for animals (10). In Austria, an average of 582 kg of vancomycin was imported for medical purposes and 62,642 kg of avoparcin for animal husbandry per year from 1992 to 1996 (11). Thus, although there are more food animals than humans, the selective pressure favoring VRE in Europe can be estimated to be much higher in food animals than in humans. Data on the yearly use of vancomycin in the United States and in major European countries were recently published by Kirst et al. (12). Denmark, a small country, used more glycopeptide growth promotant (avoparcin) than all of Europe and the United States used for treating ill humans (vancomycin). Difference in denominators implies huge difference in use (10). 

Use of Avoparcin as a Growth Promoter and the Occurrence of VRE in Food Animals
The high selective pressure by the use of glycopeptides as growth promoters could explain the presence of VRE in food animals. We have conducted a number of studies to investigate the association between the use of avoparcin as a growth promoter and the occurrence of VRE. 

In one study, eight poultry flocks raised conventionally and six raised without growth promoters were compared (13). No VRE was found in birds raised without growth promoters, whereas five out of eight conventional flocks contained VRE. Isolation rates in positive flocks were as follows: of five fecal samples tested, one to four (20%–80%) were positive. Twenty-two pig herds and 24 poultry flocks, half of which had used avoparcin and half of which had not, were compared by occurrence of VRE in fecal samples collected from animals of the herds and flocks. A strong and statistically highly significant association between the presence of VRE and the use of avoparcin was observed (14). Of 12 pig herds using feed with avoparcin, 8 had VRE, while of 10 herds not using avoparcin, 2 had VRE (p = 0.043, risk ratio [RR] 3.3; 95% confidence interval [CI]: 1.1, 10.0). In broiler farms where avoparcin was used, VRE was isolated from 11 of 12 fecal samples. In farms where avoparcin was not used, VRE was isolated in 2 of 12 samples (p <0.0006; RR 5.5; 95% CI: 2.2, 13.9). 

The association observed at the flock and herd level has also been observed at the country level. In countries where avoparcin had been used as a growth promoter, VRE could frequently be cultured from food animals, whereas in countries where avoparcin had not been used, VRE were not detected (Table 1). These findings are consistent with the hypothesis that use of avoparcin has created a reservoir for VRE in food animals.

Table 1. Avoparcin as a growth promoter 
in countries where the occurrence of 
vancomycin-resistant enterococci (VRE) 
in animal husbandry has been investigated 

--------------------------------------------------------------------------------
 
Country Avoparcin 
used VRE in 
animal 
husbandry Ref.   

--------------------------------------------------------------------------------
 
Belgium + + 15   
Denmark + + 13, 14   
Finland + + 16  
France + + 17  
Germany + + 7   
Great Britain + + 6   
The Netherlands + + 18   
Norway + + 19  
Sweden – – 20  
United States – – 21, 22  
Transmission of VRE from Animals to Humans
Can an animal reservoir in itself be regarded a public health risk? What are the chances that VRE or the resistance genes will be transmitted from animals to humans? A public health risk must be assumed to exist when transfer from animals to humans can be shown directly or indirectly. 

VRE are frequently present in food produced in Denmark as well as in food imported into Denmark from other European countries (23,24). Thus, exposure to humans from insufficiently heated food or cross-contaminated ready-to-eat food takes place. Unlike studies in the United States (21,25), European studies reported that humans frequently are fecal carriers of VRE (26-29). This suggests that VRE can be ingested from food in Europe. Furthermore, VRE was not detected in strict vegetarians in The Netherlands, supporting the view that the source of VRE is contaminated meat (Table 2) (28). 

Molecular typing shows a very high diversity of VRE types in animals as well as humans (30). Nevertheless, similar or related types have been shown to occur in animals and humans on a number of occasions, supporting the assumption that transfer of VRE between humans and animals does take place (18,19). We have recently compared 84 isolates of E. faecium from swine, chickens, and humans in Denmark by SmaI generated macrorestriction profiles and EcoRI ribotyping. Similarity analysis by unweighted pair group method with arithmetic averages–derived dendrograms did not indicate a higher degree of similarity among E. faecium isolates (VRE as well as non-VRE) from humans than from animals. This finding indirectly supports the hypothesis that E. faecium from different food animals and humans are not discrete populations but belong to a common pool of E. faecium shared by animals and humans (data not shown).

Table 2. Prevalence of vancomycin-resistant 
Enterococcus faecium in fecal samples of 
residents in a vegetarian and nonvegetarian 
nursing home, The Netherlands (28)  

--------------------------------------------------------------------------------
 
 No. persons 
investigated No. E. 
faecium 
positive No. VRE 
positivea,b  

--------------------------------------------------------------------------------
 
Vegetarians 42 23 0  
Nonvegetarians 62 32 6  

--------------------------------------------------------------------------------
 
aP<0.05. 
bAll VRE-positive samples were E. faecium.  
The VanA gene cluster encoding for vancomycin resistance in animal and human VRE is located on a transposon designated Tn1546 (32,33). Tn1546 can easily spread from one enterococcal species to another as well as from enterococci to S. aureus (33,34). Recent investigations have documented that in vivo transfer of Tn1546 can take place in the mammalian intestinal tract (A. Sundsfjord, pers. comm.). Furthermore, animal VRE can colonize the human intestinal tract for at least 3 weeks after experimental ingestion of 107 CFUs of a single strain (35). This indicates that vancomycin resistance can spread in the gastrointestinal tract from transiently colonizing animal VRE to E. faecium strains of the resident human gut flora. 

The VanA gene cluster consists of several genes. We investigated the genes and the regions between them by sequencing of selected areas, polymerase chain reaction amplification of other areas, and hybridization with specific probes (36,37). Thirteen different types were observed. Most differences arose from the presence of insertions or deletions in noncoding intergenic regions. One nucleotide difference was observed in the coding sequences; this point mutation occurred in the vanX gene at position 8234, where a G in the reference VRE strain was substituted for a T in some isolates. 

In human VRE isolates, this mutation was evenly distributed, whereas in poultry isolates from different countries only the G variant occurred; in isolates from swine from different countries the T variant occurred in nearly all isolates (Table 3). Although we have no explanation for the uneven distribution of subtypes between different animals, the finding of both types in humans does support the hypothesis that animals are a primary source of vancomycin resistance genes in humans, whereas humans apparently do not serve as reservoir for animals, in which case both types would be expected to occur in both animal species. In the same investigation, we found that all human isolates from a Muslim country belonged to the poultry subtype (37). The absence of pork variant types in a Muslim country suggests that food of animal origin is a major reservoir for VRE in humans.

Table 3. Variations in Tn1546-
like elements of vancomycin-
resistant Enterococcus faecium 
isolates of animal and human 
origin (37) 

--------------------------------------------------------------------------------
 
Source No. 
isolates T 
variant G 
variant   

--------------------------------------------------------------------------------
 
Humans   45 16   29   
Pigs   33 32     1   
Poultry 193   0 193   
Total 271 48 223   

--------------------------------------------------------------------------------
 
The European/American Paradox
Even though the greater frequency of VRE infections in U.S. than in European hospitals would seem to contradict it (12), the hypothesis that animals could serve as reservoirs of human VRE infections is supported by several lines of indirect evidence. 

Heavy use of vancomycin (and probably also third-generation cephalosporins) is a prerequisite for frequent VRE infections in hospitals. Heavy use of vancomycin and third generation cephalosporins is more frequent in U.S. than in European hospitals (12,18). Thus, the problem in Europe, irrespective of a high carrier rate of VRE in the community, has not grown to the same proportions as in the United States. VRE infections in the United States are probably due to the heavy use of antibiotics in hospitals and the eventual spread of VRE within and among hospitals by carrier personnel (38). 

Another prerequisite for high incidence of VRE hospital infections is a source of VRE. In the United States, primary sources of VRE to hospitals include travelers returning from abroad, tourists, and imported food. Once inside the hospital, VRE can cause nosocomial outbreaks because of its high potential to colonize and persist in the environment, which facilitates its persistence and spread (4). An alternative hypothesis could be that some clones of VRE have a higher potential to cause infections and that such clones are more prevalent in United States. This hypothesis, however, is contradicted by the high number of different types of VRE causing infections in Europe and the United States, which suggests that pathogenic potential is not limited to a few clones of VRE (38). 

Avoparcin was approved for growth promotion in Europe in 1974. The first VRE was detected in a human patient in France in 1986. Does this suggest that VRE was not present in animals before 1986? Historically, resistance to growth promoters in animal bacteria was not monitored, and with few exceptions the studies conducted have looked at bacteria other than enterococci because enterococci were not considered foodborne pathogens. Thus, if VRE were not detected in food animals, it may be because they were not looked for. 

The Effect of Prohibiting Use of Avoparcin as a Growth Promoter
Because of public health concerns about resistance to glycopeptide antibiotic drugs, avoparcin was banned in Denmark in 1995. In 1996, Germany took a similar step, and finally in 1997, avoparcin was banned in all EU member states. After the ban in Denmark, a marked reduction in the occurrence of VRE in Danish poultry flocks has been observed at slaughter (from 82% in 1995 to 12% of flocks in 1998; x2 = 68.3 on 5 df.; p <0.0001), whereas in swine only a minor reduction has been observed (Figure) (39). In Germany, a decrease in the incidence of VRE in poultry meat and in fecal samples from humans in the community was observed after discontinuation of avoparcin use in animal husbandry (40). In poultry meat the proportion of VRE-positive samples were reduced from 100% in 1994 to 25% in 1997, and in fecal samples from humans in the community, the carrier rate decreased from 12% in 1994 to 3% in 1997. 

  
   Figure. Trend in the proportion of Enterococcus faecium isolates  
  resistant to vancomycin (VRE) during successive half-year periods 
  from second half of 1995 to first half of 1998 (39). 
Similar Problems Related to Other Antimicrobial Growth Promoters
Most of the different growth promoters approved in the EU are active against gram-positive bacteria. With increasing resistance in gram-positive pathogenic bacteria, antimicrobial drugs used as growth promoters have attracted renewed attention as potentially useful for human therapy. More than 10 years after the first VRE was discovered, the first drug for humans with good clinical effect against VRE infections is ready to be marketed. This drug is a combination of two streptogramins, quinupristin and dalfopristin (Synercid). 

For decades, virginiamycin, which belongs to the group of streptogramins, has been used as a growth promoter in the European Union as well as in the United States, primarily for poultry production. Investigations in the United States, The Netherlands, and Denmark have frequently found Synercid-resistant E. faecium in poultry (41-43). As for VRE, we have no data on the prevalence of streptogramin-resistant E. faecium in animal husbandry before virginiamycin was used as a growth promoter. No monitoring has been carried out. Moreover, the gene (satA) conferring resistance to virginiamycin and Synercid have been found in animals and humans (44), and in vivo transfer of these genes from resistant to sensitive strains of E. faecium in the mammalian gastrointestinal tract has been shown (45). Thus, the events associated with avoparcin and vancomycin may be recurring for Synercid and virginiamycin. Furthermore, the drug anticipated to be next in line after Synercid, a compound called Ziracin, belonging to the class of everninomicins, is practically identical to another growth promoter called avilamycin, which has primarily been used in poultry. 

We have detected avilamycin resistance in 69% of E. faecium isolates from poultry in Denmark (43). Moreover, preliminary investigations show that resistance to avilamycin gives cross-resistance to Ziracin and that a transferable genetic element may be involved (46). Thus, again use of an antimicrobial drug as a growth promoter may have created a major animal reservoir of resistant E. faecium, threatening to shorten the life span of a new promising drug when it is put to use in humans. 

Future Perspectives
At the core of the VRE issue appears to be the way antimicrobial drugs are being developed. New classes of antimicrobial drugs are not available. Instead, old drugs are being modified that may have been used in agriculture as growth promoters for decades because they were not considered useful for humans. Now that physicians are searching for more options in antibiotic treatment, the older drugs may no longer be viable. The use of antimicrobial drugs and development of resistance in animals and humans are interrelated. Therefore, systems to monitor antimicrobial resistance in pathogenic and commensal bacteria should be established. Such systems should cover relevant bacteria from the entire farm-to-fork chain and monitor resistance towards antimicrobial drugs used in both animals and humans, including growth promoters (47-49). 

Finally, antimicrobial agents should not be used for growth promotion if they are used in human therapeutics or are known to select for cross-resistance to antimicrobial drugs used in human medicine (47). Antimicrobial agents are too valuable to be used as a tool in animal production because any antimicrobial drug may be useful for human therapy in the future even if not used therapeutically today. Adherence to the World Health Organization recommendations (47) will ensure a systematic approach toward replacing antimicrobial growth promoters with safer nonantimicrobial drug alternatives. The EU countries entered this process in December 1998 when four growth promoters (tylosin, spiramycin, bacitracin, and virginiamycin) were banned because of their structural relatedness to therapeutic antimicrobial drugs used for humans (50).


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

      Dr. Wegener is head of The Danish Zoonosis Centre. His research interests are veterinary public health, microbiology, epidemiology, molecular biology; control of zoonoses, particularly the so-called "modern" bacterial zoonoses; and potential public health consequences of the use of antimicrobial drugs in animal husbandry. 

      Address for correspondence: Henrik C. Wegener, Danish Zoonosis Centre, Danish Veterinary Laboratory, Bülowsvej 27, DK-1790 Copenhagen V, Denmark; fax: +45-35-300-120; e-mail: [email protected] 

References
Edmond MB, Ober JF, Weinbaum DL, Pfaller MA, Hwang T, Sanford MD, et al. Vancomycin-resistant Enterococcus faecium bacteremia: risk factors for infection. Clin Infect Dis 1995;20:1126-33. 
Leclerq R, Derlot E, Duval J, Courvalin P. Plasmid mediated resistance to vancomycin and teicoplanin in Enterococccus faecium. N Engl J Med 1988;319:157-61. 
Centers for Disease Control and Prevention. Summary of Notifiable Diseases—United States, 1997. MMWR Morb Mortal Wkly Rep 1998;46:1-87. 
Centers for Disease Control and Prevention. Recommendations for preventing the spread of vancomycin resistance. Recommendations of the Hospital Infection Control Practices Advisory Committee (HICPAC). MMWR Morb Mortal Wkly Rep 1995;44:RR12. 
House of Lords Select Committee on Science and Technology: Resistance to antibiotics and other antimicrobial agents. 1998. London: The Stationary Office; 1998. 
Bates J, Jordens J, Griffith DT. Farm animals as a putative reservoir for vancomycin resistant enterococcal infections in man. J Antimicrob Chemother 1994;34:507-16. 
Klare I, Heier H, Claus H, Reissbrodt R, Witte W. VanA-mediated high-level glycopeptide resistance in Enterococcus faecium from animal husbandry. FEMS Microbiol Lett 1995;125:165-72. 
Jensen BB. The impact of feed additives on the microbial ecology of young pigs. Journal of Animal and Feed Sciences 1998;7:45-64. 
McDonald CL, Kuehnert MJ, Tenover FC, Jarvis WR. Vancomycin-resistant enterococci outside the health care setting: prevalence, sources, and public health. Emerg Infect Dis 1997;3:311-7. 
Wegener HC. Historical usage of glycopeptides for animals and humans—the American/European paradox revisited. Antimicrob Agents Chemother 1998;42:3049. 
Witte W. Medical consequences of antibiotic use in agriculture. Science 1998;279:996-7. 
Kirst HA, Thompson DG, Nicas TI. Historical yearly usage of vancomycin [letter]. Antimicrob Agents Chemother 1998;42:1303-4. 
Aarestrup FM. Occurrence of glycopeptide resistance among Enterococcus faecium isolates from ecological and conventional poultry farms. Microb Drug Resist 1995;1:255-7. 
Bager F, Madsen M, Christensen J, Aarestrup FM. Avoparcin used as a growth promoter is associated with the occurrence of vancomycin-resistant Enterococcus faecium on Danish poultry and pig farms. Prev Vet Med 1997;31:95-112. 
Devriese LA, Ieven M, Goosens H, Vandamme P, Pot B, Hommez J, et al. Presence of vancomycin-resistant enterococci in farm and pet animals. Antimicrob Agents Chemother 1996;40:2285-7. 
Tast E, Myllys V, Honkanen-Buzalski T. A survey of resistance to some antimicrobials of enterococcal and E. coli strains isolated from pigs and broilers in Finland. In: Proceedings of NKVet Symposium on Antibiotic Resistance. 1997 Nov 7-8. Danish Veterinary Association, Sundvolden, Norway. p. 44. 
Boisivon A, Vauchel JC, Cheron M, Gobert A, Leturdu F, Chambreuil G, et al. Vancomycin resistant enterococci (VRE) from food animal sources in France. In: Proceedings of the 97th General Meeting of the American Society of Microbiology; 1997 May 4-8; Miami Beach, Florida. Washington: American Society of Microbiology; 1997. 
van den Bogaard AE, Jensen LB, Stobberingh EE. Vancomycin-resistant enterococci in turkeys and farmers. N Engl J Med 1997a;337:1558-9. 
Simonsen GS, Haaheim H, Kruse H, Dahl KH, Olsvik Ø, Sundsfjord A. Glycopeptide resistant Enterococci (GRE) at avoparcin-using farms: possible transmission of strains and the vanA gene cluster between chicken and humans. In: Proceedings of NKVet Symposium on Antibiotic Resistance. 1997 Nov 7-8. Danish Veterinary Association, Sundvolden, Norway. p. 41. 
Quednau M, Ahrné S, Molin G. Antibiotic resistant enterococci in Swedish and Danish pork and poultry. In: Proceedings of Symposium on Food Associated Pathogens; 1996 May 6-8; The Swedish University of Agricultural Sciences, The Swedish National Committee of Food Science and Technology, and the International Union of Food Science and Technology, Uppsala, S
 

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References
Edmond MB, Ober JF, Weinbaum DL, Pfaller MA, Hwang T, Sanford MD, et al. Vancomycin-resistant Enterococcus faecium bacteremia: risk factors for infection. Clin Infect Dis 1995;20:1126-33.
Leclerq R, Derlot E, Duval J, Courvalin P. Plasmid mediated resistance to vancomycin and teicoplanin in Enterococccus faecium. N Engl J Med 1988;319:157-61.
Centers for Disease Control and Prevention. Summary of Notifiable Diseases—United States, 1997. MMWR Morb Mortal Wkly Rep 1998;46:1-87.
Centers for Disease Control and Prevention. Recommendations for preventing the spread of vancomycin resistance. Recommendations of the Hospital Infection Control Practices Advisory Committee (HICPAC). MMWR Morb Mortal Wkly Rep 1995;44:RR12.
House of Lords Select Committee on Science and Technology: Resistance to antibiotics and other antimicrobial agents. 1998. London: The Stationary Office; 1998.
Bates J, Jordens J, Griffith DT. Farm animals as a putative reservoir for vancomycin resistant enterococcal infections in man. J Antimicrob Chemother 1994;34:507-16.
Klare I, Heier H, Claus H, Reissbrodt R, Witte W. VanA-mediated high-level glycopeptide resistance in Enterococcus faecium from animal husbandry. FEMS Microbiol Lett 1995;125:165-72.
Jensen BB. The impact of feed additives on the microbial ecology of young pigs. Journal of Animal and Feed Sciences 1998;7:45-64.
McDonald CL, Kuehnert MJ, Tenover FC, Jarvis WR. Vancomycin-resistant enterococci outside the health care setting: prevalence, sources, and public health. Emerg Infect Dis 1997;3:311-7.
Wegener HC. Historical usage of glycopeptides for animals and humans—the American/European paradox revisited. Antimicrob Agents Chemother 1998;42:3049.
Witte W. Medical consequences of antibiotic use in agriculture. Science 1998;279:996-7.
Kirst HA, Thompson DG, Nicas TI. Historical yearly usage of vancomycin [letter]. Antimicrob Agents Chemother 1998;42:1303-4.
Aarestrup FM. Occurrence of glycopeptide resistance among Enterococcus faecium isolates from ecological and conventional poultry farms. Microb Drug Resist 1995;1:255-7.
Bager F, Madsen M, Christensen J, Aarestrup FM. Avoparcin used as a growth promoter is associated with the occurrence of vancomycin-resistant Enterococcus faecium on Danish poultry and pig farms. Prev Vet Med 1997;31:95-112.
Devriese LA, Ieven M, Goosens H, Vandamme P, Pot B, Hommez J, et al. Presence of vancomycin-resistant enterococci in farm and pet animals. Antimicrob Agents Chemother 1996;40:2285-7.
Tast E, Myllys V, Honkanen-Buzalski T. A survey of resistance to some antimicrobials of enterococcal and E. coli strains isolated from pigs and broilers in Finland. In: Proceedings of NKVet Symposium on Antibiotic Resistance. 1997 Nov 7-8. Danish Veterinary Association, Sundvolden, Norway. p. 44.
Boisivon A, Vauchel JC, Cheron M, Gobert A, Leturdu F, Chambreuil G, et al. Vancomycin resistant enterococci (VRE) from food animal sources in France. In: Proceedings of the 97th General Meeting of the American Society of Microbiology; 1997 May 4-8; Miami Beach, Florida. Washington: American Society of Microbiology; 1997.
van den Bogaard AE, Jensen LB, Stobberingh EE. Vancomycin-resistant enterococci in turkeys and farmers. N Engl J Med 1997a;337:1558-9.
Simonsen GS, Haaheim H, Kruse H, Dahl KH, Olsvik Ø, Sundsfjord A. Glycopeptide resistant Enterococci (GRE) at avoparcin-using farms: possible transmission of strains and the vanA gene cluster between chicken and humans. In: Proceedings of NKVet Symposium on Antibiotic Resistance. 1997 Nov 7-8. Danish Veterinary Association, Sundvolden, Norway. p. 41.
Quednau M, Ahrné S, Molin G. Antibiotic resistant enterococci in Swedish and Danish pork and poultry. In: Proceedings of Symposium on Food Associated Pathogens; 1996 May 6-8; The Swedish University of Agricultural Sciences, The Swedish National Committee of Food Science and Technology, and the International Union of Food Science and Technology, Uppsala, Sweden. p. 254.
Coque TM, Tomayko JF, Ricke SC, Okhuysen PC, Murray B. Vancomycin-resistant enterococci from nosocomial, community and animal sources in the United States. Antimicrob Agents Chemother 1996;40:2605-9.
Thal LA, Chow JW, Mahayni R, Bonilla H, Donabedian SA, Silverman J, Taber S, Zervos MJ. Characterization of antimicrobial resistance in enterococci of animal origin. Antimicrob Agents Chemother 1996;39:2112-5.
Wegener HC, Madsen M, Nielsen N, Aarestrup FM. Isolation of vancomycin resistant Enterococcus faecium from food. Int J Food Microbiol 1997;35:57-66.
Danish Zoonosis Centre. Consumption of antimicrobial agents and occurrence of antimicrobial resistance in bacteria from food animals, food and humans in Denmark. No. 1, Feb 1997. Copenhagen, Denmark: Danish Integrated Antimicrobial Resistance Monitoring and Research Programme (DANMAP).
Silverman J, Thal LA, Perri MB, Bostic G, Zervos MJ. Epidemiological evaluation of antimicrobial resistance in community-acquired enterococci. J Clin Microbiol 1998;36:830-2.
Van der Auwera P, Pensart N, Korten V, Murray B. Influence of oral glycopeptides on the faecal flora of human volunteers: selection of highly glycopeptide resistant enterococci. J Infect Dis 1996;173:1129-36.
Gordts B, Van Landuyt H, Ieven M, Vandamme P, Goossens H. Vancomycin-resistant enterococci colonizing the intestinal tract of hospitalized patients. J Clin Microbiol 1995;33:2842-6.
Schouten MA, Voss A, Hoogkamp-Korstanje JAA. VRE and meat. Lancet 1997;349:1258.
Ieven M, Vercauteren E, Descheemaeker P, Goosens H. Significant increase in detection of intestinal carriers of glycopeptide resistant enterococci by enrichment cultures [abstract] In: Abstracts of the 37th Interscience Conference on Antimicrobial Agents and Chemotherapy; September 30, 1997 ; Toronto, Canada. Abstract D-118.
Van den Brak N, van Belkum A, van Keulen M, Vliegendhart J, Verbrugh HA, Endtz HP. Molecular characterisation of vancomycin-resistant enterococci from hospitalised patients and poultry products in the Netherlands. J Clin Microbiol 1998;36:1927-32.
Arthur M, Courvalin P. Genetics and mechanisms of glycopetide resistance in enterococci. Antimcrob Agents Chemother 1993;37:95-112.
Aarestrup FM, Ahrens P, Madsen M, Pallesen LV, Poulsen RL, Westh H. Glycopeptide susceptibility among Danish Enterococcus faecium and Enterococcus faecalis isolates of animal and human origin and PCR identification of genes within the VanA cluster. Antimicrob Agents Chemother 1996;40:1938-40.
Leclercq R, Derlot E, Weber M, Duval J, Courvalin P. Transferable vancomycin and teicoplanin resistance in Enterococcus faecium. Antimicrob Agents Chemother 1989;33:10-5.
Noble WC, Virani Z, Cree RG. Co-transfer of vancomycin and other resistance genes from Enterococcus faecalis NCTC 12201 to Staphylococcus aureus. FEMS Microbiol Lett 1992;72:195-8.
Berchieri A. Intestinal colonization of a human subject by vancomycin-resistant Enterococcus faecium. Clin Micrbiol Infect 1999;5:97-100.
Jensen LB, Ahrens P, Dons L, Jones RN, Hammerum A, Aarestrup FM. Molecular analysis of the Tn1546 from vancomycin resistant enterococci isolated from animals and humans. J Clin Microbiol 1998;36:437-42.
Jensen LB. Differences in the occurrence of two base pair variants of Tn1546 from vancomycin-resistant enterococci from humans, pigs and poultry. Antimicrob Agents Chemother 1998;42:2463-4.
Thal L, Donabedian S, Robinson-Dunn B, Chow JW, Dembry L, Clewell DB, et al. Molecular analysis of glycopeptide-resistant Enterococcus faecium isolates collected from Michigan hospitals over a 6-year period. J Clin Microbiol 1998;36:3303-8.
Bager F, Aarestrup FM, Madsen M, Wegener HC. Glycopeptide resistance in Enterococcus faecium from broilers following discontinued use of avoparcin. Microb Drug Resist 1999;5:(in press).
Klare I, Badstübner D, Konstabel C, Böhme G, Claus H, Witte W. Decreased incidence of VanA-type vancomycin-resistant enterococci isolated from poultry meat and from fecal samples of humans in the community after discontinuation of avoparcin usage in animal husbandry. Microb Drug Resist 1999;5 (in press).
Welton LA, Thal LA, Perri MB, Donabedien S, McMahon J, Chow JW, et al. Antimicrobial resistance in enterococci isolated from turkey flocks fed virginiamycin. Antimicrob Agents Chemother 1998;42:705-8.
Van den Bogaard AE, Mertens P, London NH, Stobberingh EE. High prevalence of vancomycin- and pristinamycin-resistant enterococci in healthy humans and animals in The Netherlands: is the addition of antibiotics to animal feed to blame? Antimicrob Agents Chemother 1997;40:454-6.
Aarestrup FM, Bager F, Madsen M, Jensen NE, Meyling A, Wegener HC. Surveillance of antimicrobial resistance in bacteria isolated from food animals to growth promoters and related therapeutic agents in Denmark. APMIS 1998;106:606-22.
Hammerum AH, Jensen LB, Aarestrup FM. Detection of the SatA gene and transferability of virginiamycin resistance in Enterococcus faecium from food animals. FEMS Microbiol Lett 1998;168:145-51.
Jakobsen BM, Skou M, Hammerum AM, Jensen LB. In vivo transfer of the satA gene between isogenic strains of Enterococcus faecium in the mammalian gastrointestinal tract. In: Proceedings of the Second World Congress on Anaerobic Bacteria and Infections; 1998 Oct 3-6; Nice, France.
Aarestrup FM. Association between decreased susceptibility to a new antibiotic for treatment of human diseases; everninomicin (SCH 27899), and resistance to an antibiotic used for growth promotion in animals, avilamycin. Microb Drug Resist 1998;4:137-41.
The medical impact of the use of antimicrobials in food animals. Report from a WHO meeting; Berlin, Germany 1997 Oct 13-17. Geneva: World Health Organization; 1997.
The role of international trade in animals, animal products and feed in the spread of transferable antimicrobial resistance and possible methods for control of the spread of infectious agent resistance factors. In: Proceedings of the 18th Conference of the Office International des Epizooties (OIE) Regional Commission of Europe; 1998 Sep 22-25; Prague, Czech Republic.
The Copenhagen recommendation. Report from the invitational EU conference on the microbial threat; 1998 Sep 9-10; Copenhagen, Denmark. (Internet address http://www.sum.dk/publika/micro98/index.htm).
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http://www.cdc.gov/ncidod/EID/vol5no3/wegener.htm


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flounder

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European Food Safety Authority

Brussels, 12 September 2005

EFSA/CONTAM/329

CALL FOR SCIENTIFIC DATA RELATED TO LEGALLY USED GROWTH PROMOTING

HORMONES IN BOVINES (EFSA-Q-2005-048)

INVITATION FOR SCIENTIFIC DATA SUBMISSIONS

Deadline for submissions: 4 November 2005

1. BACKGROUND

Directive 96/22/EC1 as amended by Directive 2003/74/EC2 restricts the use of hormones in food

producing animals. These restrictions are based on risk assessments carried out by the Scientific

Committee on Veterinary Measures relating to Public Health (SCVPH) which gave advice to the

European Commission (DG Health and Consumer Protection) in 1999, 2000 and 2002.

Recently, EFSA was asked by the European Commission to perform a review of scientific data

on potential risks to human health from hormone residues in bovine meat and meat products

(EFSA-Q-2005-048) which has become available since the latest opinion by the SCVPH in 2002.

Within EFSA this task was assigned to the Scientific Panel on Contaminants in the Food Chain

(CONTAM).

1 OJ, L 125, 23.5.1996, p. 3-9

2 OJ, L 262, 14.102003, p. 17-21

CONTAM 329 -call for hormon data (4).doc Page 1 of 3

CONTAM 329 -call for hormon data (4).doc Page 2 of 3

2. CALL FOR SCIENTIFIC DATA

EFSA invites all interested parties3 to submit any scientific evidence (from 2002 onwards) on

substances with hormonal activity which may be used legally in Third Countries for growth

promotion purposes in bovine meat having oestrogenic, androgenic or gestagenic action since the

last review of the Assessment of Potential Risks to Human Health from Hormone Residues in

Bovine Meat and Meat Products of the SCVPH in 20024 following the criteria outlined under

item 3.

3. GENERAL CONDITIONS FOR DATA SUBMISSIONS

To facilitate an effective handling of incoming documents, interested parties are requested to

submit documents to the following email address: [email protected]

The acceptance of the scientific contributions will be based on the compliance with the general

EFSA criteria for acceptance of scientific documents and data for risk assessment purposes as

indicated below. Non-compliance with these general quality criteria will result in the rejection of

the contribution provided.

1. The name and contact details of the party providing the scientific contribution is required.

2. Scientific contributions should be classified by the interested party as i) peer-reviewed data or

ii) non peer-reviewed data.

EFSA encourages submission of peer-reviewed data/publications (not just the reference) as

the most relevant and reliable documents. Non peer-reviewed data (as for examples industry

reports in agreement with point 5) will only be considered if they are based on scientific

evidence and if they meet adequate quality standards.

3 Such as industry, academics, consumer organisations, governmental institutions as well as EU Member States and

the EU Parliament.

4 http://europa.eu.int/comm/food/fs/sc/scv/out50_en.pdf

5 In case postal submissions are necessary following address should be used:

European Food Safety Authority - EFSA

CONTAM – Hormones

Rue de Genève 10

B-1140 Brussels

Belgium

CONTAM 329 -call for hormon data (4).doc Page 3 of 3

3. A list of attached documents and their references should be included into the body of the

mail.

4. Copyright

As a matter of principle, the owner of the copyright of scientific contributions will authorise

EFSA to reproduce, distribute or communicate these scientific contributions. Refusals to

grant EFSA such authorisation should be considered unacceptable unless in exceptional cases

they are duly justified. In all cases EFSA will acknowledge the source.

If the submission of the scientific contribution includes documents of which the copyright is

not owned by the submitting party, the contribution should be accompany by the

authorisation of the copyright owner to allow reproduction, distribution or communication of

the documents.

5. Confidentiality

The documents shall normally not include confidential information. The inclusion of

confidential data should be duly justified and should be considered by EFSA on a case-bycase

basis. The contributor should take duly into account the rights of interested parties.

6. Language regime

Given the short deadlines, the need to harmonise the documents and the potential large

number of documents to be received, processing would be greatly facilitated if documents are

submitted in English.



http://www.efsa.eu.int/science/contam/contam_documents/1134/contam_call_hormon_data1.pdf



OPINION OF THE

SCIENTIFIC COMMITTEE ON VETERINARY MEASURES RELATING TO

PUBLIC HEALTH

ON

Review of previous SCVPH opinions of 30 April 1999 and 3 May 2000 on the

potential risks to human health from hormone residues

in bovine meat and meat products

(adopted on 10 April 2002)



snip...



21

6. IMPACT OF THE EXTENSIVE USE OF HORMONALLY ACTIVE COMPOUNDS ON THE

ENVIRONMENT

The potential endocrine disrupting activity of anabolic steroids used in beef

production has not been addressed in the previous Opinions of the SCVPH. The

emerging concerns, related to compounds generally referred to as Endocrine

Disruptors, stimulated investigations towards the potential hazards related to the

extensive use of hormones in beef production. Thus, the results obtained in the

frame of the 17 studies will be presented briefly in Annex 1.

It has to be acknowledged that the Scientific Committee on Toxicity, Ecotoxicity

and the Environment (CSTEE) has issued an Opinion in 1999 on "Human and

wildlife health effects of endocrine disrupting chemicals, with emphasis on wildlife

and on ecotoxicology test methods".

7. GENERAL CONCLUSIONS

The review of the 17 studies launched by the European Commission and a recent

scientific literature allows the following conclusions:

Ultra-sensitive methods to detect residues of hormones in animal tissues have

become available, but need further validation.

Studies on the metabolism of 17-oestradiol in bovine species indicate the

formation of lipoidal esters, disposed particularly in body fat. These lipoidal

esters show a high oral bioavailability in rodent experiments. Thus, the

consequence of their consumption needs to be considered in a risk assessment.

Experiments with heifers, one of the major target animal groups for the use of

hormones, indicated a dose-dependent increase in residue levels of all hormones,

particularly at the implantation sites. Misplaced implants and repeated

implanting, which seem to occur frequently, represent a considerable risk that

highly contaminated meats could enter the food chain. There is also a dosedependent

increase in residue levels following the oral administration of

melengestrol acetate at doses exceeding approved levels, with a corresponding

increased risk that contaminated meats could enter the food chain.

Convincing data have been published confirming the mutagenic and genotoxic

potential of 17-oestradiol as a consequence of metabolic activation to reactive

quinones. In vitro experiments indicated that oestrogenic compounds might alter

the expression of an array of genes. Considering that endogenous oestrogens also

exert these effects, the data highlight the diverse biological effects of this class of

hormones.

No new data regarding testosterone and progesterone relevant to bovine meat or

meat products are available. However, it should be emphasized that these natural

hormones are used only in combination with 17-oestradiol or other oestrogenic

compounds in commercial preparations.

Experiments with zeranol and trenbolone suggested a more complex oxidative

metabolism than previously assumed. These data need further clarification as

they might influence a risk assessment related to tissue residues of these

compounds.

Zeranol and trenbolone have been tested for their mutagenic and genotoxic

potential in various systems with different endpoints. Both compounds exhibited

only very weak effects.

Data on the genotoxicity of melengestrol acetate indicate only weak effects.

However, pro-apoptotic effects were noted in some cell-based assays, which were

attributed to the impurities in commercial formulation. Further experiments

should clarify the toxicological significance of these impurities.

Model experiments with rabbits treated with zeranol, trenbolone or melengestrol

acetate, mirroring their use in bovines, were designed to study the consequences

of pre- and perinatal exposure to exogenous hormones. All compounds crossed

the placental barrier easily and influenced to varying degrees the development of

the foetus, at the doses used in the experiments.

Epidemiological studies with opposite-sexed twins, suggest that the exposure of

the female co-twin in utero to hormones results in an increased birth weight and

consequently an increased adult breast cancer risk.

Several studies were devoted to the potential impact of the extensive use of

hormones on the environment. Convincing data were presented indicating the

high stability of trenbolone and melengestrol acetate in the environment, whereas

preliminary data were provided on the potential detrimental effects of hormonal

compounds in surface water.

In conclusion, after re-appraisal of the data from the 17 studies and recent scientific

literature, the SCVPH confirms the validity of its previous Opinions (in 1999 and

2000) on the Assessment of Potential Risks to Human Health from Hormone

Residues in Bovine Meat and Meat Products, and that no amendments to those

opinions are justified.

see full text 34 pages;

http://europa.eu.int/comm/food/fs/sc/scv/out50_en.pdf



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flounder

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OPINION OF THE

SCIENTIFIC COMMITTEE ON VETERINARY MEASURES

RELATING TO PUBLIC HEALTH

ASSESSMENT OF POTENTIAL RISKS TO HUMAN HEALTH FROM

HORMONE RESIDUES IN BOVINE MEAT AND MEAT PRODUCTS

_________________________

30 APRIL 1999

(references completed)



SNIP...



72

In summary

Taking into account both the hormonal and non-hormonal toxicological effects as

mentioned above, and described in more detail in the report, it has to be concluded that

the issues of concern include neurobiological, developmental, reproductive and

immunological effects, as well as immunotoxicity, genotoxicity and carcinogenicity. In

consideration of the recent concerns relating to the lack of understanding of critical

developmental periods in human life as well as the uncertainties in the estimates of

endogenous hormone production rates and metabolic clearance capacity, particularly in

prepubertal children, no threshold level and therefore no ADI can be established for any of

the 6 hormones.

Major conclusions

· As concerns excess intake of hormone residues and their metabolites, and in view of

the intrinsic properties of hormones and epidemiological findings, a risk to the

consumer has been identified with different levels of conclusive evidence for the 6

hormones in question.

· In the case of 17 b oestradiol there is a substantial body of recent evidence suggesting

that it has to be considered as a complete carcinogen, as it exerts both tumour

initiating and tumour promoting effects. The data available does not allow a

quantitative estimate of the risk.

· For the other 5 hormones, in spite of the individual toxicological and epidemiological

data described in the report, the current state of knowledge does not allow a

quantitative estimate of the risk.

· For all six hormones endocrine, developmental, immunological, neurobiological,

immunotoxic, genotoxic and carcinogenic effects could be envisaged. Of the various

susceptible risk groups, prepubertal children is the group of greatest concern. Again

the available data do not enable a quantitative estimate of the risk.

· In view of the intrinsic properties of the hormones and in consideration of

epidemiological findings, no threshold levels can be defined for any of the 6

substances.



SNIP...

FULL TEXT 142 PAGES;



http://europa.eu.int/comm/food/fs/sc/scv/out21_en.pdf




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rancher

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Flounder, could I have the Reader's Digest form, PLEASE
 

Mike

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rancher said:
Flounder, could I have the Reader's Digest form, PLEASE

Me too! Rancher. I bet this guy leaves a trail of words when he walks in the yard!

Remember the song, " Oh I Lobster, and never Flounder"?
 

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