http://www.fda.gov/foi/warning_letters/g5666d.htm
No
Michael Mumbulo
12/08/05
New York District Office New Animal Drugs/Extralabel Drug Use in Animals/Adulterated/Misbranded [PDF]
[HTML] http://www.fda.gov/foi/warning_letters/g5665d.htm
No
WaJa Farms, Inc
12/06/05
New York District Office New Animal Drugs/Extralabel Drug Use in Animals/Adulterated/Misbranded [PDF]
[HTML] http://www.fda.gov/foi/warning_letters/g5664d.htm
No
=========
THESE WARNING LETTERS are just one weeks worth. there are literally 100s of these if you do a good search.
MY point here,
a serious bout with MRSA;
Subject: FSIS TO HOLD INTERNATIONAL MEAT AND POULTRY FOOD SAFETY MEETING
Date: Mon, 10 Mar 2003 15:41:55 -0600
From: "Terry S. Singeltary Sr."
To: [email protected].
CC: [email protected]., [email protected]., [email protected]., [email protected].
Greetings FSIS,
in response to public meeting on March 27 on
food safety;
My name is Terry S. Singeltary Sr. and i wish to make
submission to this meeting. i am disabled from neck
injury and cannot come to meeting. i wish my submission
to be made public at the meeting please.
> Topics will include global perspectives on multi-drug
> resistant pathogens, assisting small plants in meeting
> food safety requirements and biosecurity.
i wish to comment on all topics.
i will try and make my nightmare as short as possible.
my mother died on 12-14-97 of Heidenhain Variant Creutzfeldt
Jakob Disease, an exceedingly rare strain of sporadic CJD,
now documented at 6 known phenotypes. i have researched human
animal TSEs for almost 6 years. i am no doctor, i have no
PhDs and i am President of nothing. i will get to food
safety and bio-security last...
1st -- milti-drug resistant pathogens
Nov. 30, 2001, i went in for my 3rd neck surgery,
second inter body fusion (always use my own blood
and bone). this time around they were to fuse all
my neck and add a titanium plate. since there is
no, I REPEAT NO questions on hospital admittance
forms of any kind asking about CJD/TSEs, i thought i
should inform him my situation with my mother and hvCJD.
i cannot give blood, be a donor of any kind and since
mom did die from hvCJD, they did use some disposable
items and did use a bone grinder that would not be used
on anyone else and i did share a lot of data with my
neurosurgeon about all this (with reference).
now, as my neurosurgeon said, damn terry, this was not
suppose to happen to you. i refused blood and bone
due to CJD/TSEs, and what do you suppose happened,
somehow (as with TSEs, nobody knows), they infected
with MRSA (methicillin resistant _Staphylococcus aureus_),
damn near killed me. about 7 weeks of vancomycin with long
line straight to heart. course nobody would fess up to it,
but every nurse i spoke with said it was hospital acquired,
and the week i was in there i was told there were 7 cases
from that hospital room? i have never been the same since,
but who's asking.
now, as my nightmare through the world of TSEs continued,
i began searching data on MRSA. while looking for
ruminant-to-ruminant feed ban warning letters aka mad cow
feed ban warning letters (before FDA stopped issuing
them, all this will be documented below), i began seeing
these warning letters on antibiotic and hormone use of
all sorts in cattle. the more i researched, the more disgusted
i got. human drugs (or equal) being used in mass proportion
by the cattle industry, on animals to sick to slaughter.
i have often wondered why young girls are maturing at such
young ages (hormones in cattle/dairy products), and why humans
were becoming resistant to antibiotics (antibiotic use in cattle),
then it all began to make sense. so, i would like to submit
the below data with reference's. i will first reference
the warning letters on antibiotics and hormones, then
will post url with much more data on the topic. please
look at where the data is referenced from. then i will
post data on meat safety (TSEs) and finally something
i submitted to the documents on bio-security in the USA
with potentially TSE/BSE tainted products entering the USA
through a BIG hole (passenger air traffic and TSE/BSE
SUITCASE BOMBS)...
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3145
March 18, 2002
Ref: 2002-DAL-WL-12
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. Richard L. Hayes, Owner
Richard Hayes Cattle Company
Route 4, Box 186B
Hereford, Texas 79045
Dear Mr. Hayes:
An inspection conducted by our investigator at your cattle buyer/dealer
operation located at Hereford, Texas, on February 11-12, 2002, confirmed
that you offered animals 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).
On or about June 29, 2001, you delivered and offered for slaughter as
human food, a steer identified with ear tag 667490 to [redacted]. USDA
analysis of tissue samples collected from that animal identified the
presence of 9.90 ppm of tilmicosin in the liver, and 13.70 ppm
tilmicosin in the muscle tissue. A tolerance of 1.2 ppm has been
established for residues of tilmicosin in the edible tissues of cattle
[Title 21, Code of Federal Regulations
(CFR) Part 556.7351. The presence of this drug in edible tissue from
this animal
causes the food to be adulterated.
On or about June 29, 2001, you delivered and offered for slaughter as
human food, a steer identified with ear tag 1076 to [redacted]. USDA
analysis of tissue samples collected from that animal identified the
presence of 0.36 ppm penicillin in the kidney, and 0.07 ppm penicillin
in the liver tissue. A tolerance of 0.05 ppm has been established for
residues of penicillin in the edible tissues of cattle (21 CFR 556.510).
The presence of this drug in edible tissue from this animal causes the
food to be adulterated.
On or about October 5, 2001, you delivered and offered for slaughter as
human
food, a steer identified with ear tag COR632 to [redacted]. USDA
analysis of tissue samples collected from that animal identified the
presence of 0.34 ppm sulfadimethoxine in the muscle tissues. A tolerance
of 0.1 ppm has been established for residues of sulfadimethoxine in the
edible tissues of cattle (21 CFR 556.640). The presence of this drug in
edible tissue from this animal causes the food to be adulterated.
On or about October 26, 2001, you delivered and offered for slaughter as
human food, a steer identified with back tag 1203 and ear tag 9705 to
[redacted]. USDA analysis of tissue samples collected from that animal
identified the presence of 2.90 ppm of sulfadimethoxine in the muscle
and 2.96 ppm in the liver tissue. A tolerance of 0.1 ppm has been
established for residues of sulfadimethoxine in the edible tissues of
cattle (21 CFR 556.640). The presence of this drug in edible tissue from
this animal causes the food to be adulterated.
On or about November 6, 2001, you delivered and offered for slaughter as
human food, a steer identified with back tag 3811 to [redacted]. USDA
analysis identified the presence of 0.07 ppm penicillin in the kidney. A
tolerance of 0.05 ppm has beep established for residues of penicillin in
the edible tissues of cattle (21 CFR 556.510). The presence of this drug
in edible tissue from this animal causes the food to be adulterated.
On or about November 13, 2001, you delivered and offered for slaughter
as human food, a steer identified with ear tag 227 to [redacted]. USDA
analysis of tissue samples collected from that animal identified the
presence of 63.78 ppm gentamicin sulfate in the kidney, and 12.97
gentamicin sulfate in the liver tissue. No tolerance has been
established for residues of gentamicin sulfate in the edible tissues of
cattle (21 CFR 556.300). The presence of this drug in edible tissue from
this animal causes the food to be adulterated.
Prior to the most recent inspection of February 11-12, 2002, you had
been inspected by a representative of the Texas Department of Health on
two previous occasions, January 24 and June 8, 2000. Those inspections
revealed that you have no system in place to determine whether an animal
you purchase and subsequently offer for slaughter as human food, has
been medicated, and whether it should be withheld from slaughter in
order to allow for potentially harmful drug residues to be depleted.
During the February 1l-12, 2002, inspection, our investigator found
essentially the
same objectionable conditions observed by the Texas Department of
Health. Our
investigator also found that you hold animals under conditions 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 a
system to
identify and quarantine treated animals you purchase from cattle
sellers. Also,
you lack a system for assuring that animals, medicated prior to your
purchase
have been withdrawn from medication for appropriate periods of time to
permit
depletion of potentially hazardous residues of drugs from edible
tissues. Food
from animals held under such conditions is adulterated within the meaning
402(a)(4) of the Act.
The above is not intended to be an all-inclusive list of violations. As
a buyer/dealer 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. As a dealer of animals, you are
frequently the individual who introduces or offers for introduction into
interstate commerce, the adulterated animal. As such, you share the
responsibility for violating the Federal Food, Drug and Cosmetic Act. To
avoid future illegal residue violations you should take precautions such as:
1. implementing a system to identify the animals you purchase with
records to establish traceability to the source of the animal;
2. implementing a system to determine from the source of the animal
whether the animal has been medicated and with what drug(s); and
3. if the animal has been medicated, implementing a system to withhold
the animal from slaughter for an appropriate period of time to deplete
potentially hazardous residues of drugs from edible tissue. If you do
not want to hold the medicated animal then it should not be offered for
human food, and it should be clearly identified and sold as a medicated
animal.
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.
It is not necessary for you to personally ship an adulterated animal in
interstate commerce to be responsible for a violation of the Federal
Food, Drug, and Cosmetic Act. The fact that you caused the adulteration
of an animal that was 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 that has been, or 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 reply should be directed to the Food and Drug Administration,
Attention:
Reynaldo R. Rodriguez, Jr., Director, Compliance Branch, at the above
letterhead address.
Sincerely,
Dallas District Director
http://www.fda.gov/foi/warning_letters/g3156d.htm
=================================================
another example;
snip...
Our investigation 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 a system for assuring that drugs are used in a
manner not contrary to label instructions, and for assuring animals
medicated on your farm have been withheld from slaughter for appropriate
periods of time to permit depletion of potentially hazardous drug
residues from edible tissues. Food from animals held under such
conditions adulterated within the meaning of Section 402(a)(4) of the Act.
Our investigation also revealed that you caused a drug oxytetracycline
hydrochloride injection (Agrimycin 100) to be unsafe within the meaning
of Section 512 of the Act and adulterated under Section 501(a)(5) of the
Act when you used the drug in an extralabel manner without veterinary
supervision. This drug is indicated for use in non-lactating dairy
cattle and for intravenous use only. Your use of this drug for treatment
of mastitis by intramuscular injection or for treatment of a retained
placenta by intrauterine injection in a lactating cow in an amount not
indicated causes the drug to be unsafe to use.
snip...
http://www.fda.gov/foi/warning_letters/g3763d.htm
Greetings again FSIS,
those are just two examples of _many_ warning letters
of this nature, there are many more. these are just two
of the month of March 2002, there were 14 such warning
letters in this month that i found and that were documented;
http://63.75.126.221/scripts/wlcfm/subject.cfm?FL=I
now this super-bug is getting meaner, now we have VRSA;
Staphylococcus aureus
Methicillin Resistant to Vancomycin Resistant
United States, 2002
snip...
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.
snip...
http://jama.ama-assn.org/issues/v288n7/ffull/jwr0821-1.html
for the medical and scientific community, i would not
_flounder_ around with these agents either. i know!
you continue to let the industries involved and the
politicians/lobbyist dictate science, these super-bugs
will spread across the world as did TSEs. The USA cannot
hide TSE in USA cattle much longer. please let me move
on...
now to move on to animal TSEs and the risk to the
USA food supply from within and abroad. the USA
has flagrantly violated the 8/4/97 ruminant-to-ruminant
_voluntary_ feed ban, which is still violated today.
i have well documented this below, but first i must ask, ...snip...end...TSS
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
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
TSS