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From: TSS ()
Date: March 16, 2007 at 9:01 am PST

Public Health Service
Food and Drug Administration

Minneapolis District Office
Central Region
212 Third Avenue South
Minneapolis, MN 55401
Telephone: (812) 758-7132
FAX: (812) 334-4142

February 28, 2007



Refer to MIN 07-14

Roger A. Lanners
Julie A. Lanners
18576 83rd Street
Royalton, Minnesota 56373

Dear Mr. and Mrs. Lanners:

An investigation of your dairy operation located in Royalton, Minnesota, was conducted by investigators from the Minnesota Department of Agriculture, acting on behalf of the U.S. Good and Drug Administration (FDA), on October 26, 2006. This investigation confirmed that you offered animals for sale for slaughter as food that were adulterated under sections 402(a)(2){C)(u) [21 U.S.C. 342(a)(2)(C)(ii)] and 402(a)(4) [21 U.S.C. 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act; (the Act). The inspection also revealed that you caused the new animal drugs sulfadimethoxine, oxytetracycline hydrochloride; penicillin G procaine, amoxicillin, and isoflupredone acetate to be unsafe under section 512 [21 U.S.C. 360b] of the Act and adulterated within the meaning of section 501(a){S) [21 U.S.C. 351{a)(5)] of the Act. You can find the Act and its associated regulations on the Internet through links on the FDA web page at

On or about August 18, 2006, you sold to [redacted] a dairy cow identified with your ear tag #905 and cross-referenced to back tag #4747 for slaughter as food. On or about August 18, 2006, this animal was slaughtered at [redacted].The United States Department of Agriculture Food Safety and Inspection Service,(USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 27 parts per million (ppm) oxytetracycline in kidney tissue, 0.30 ppm sulfadimethoxine in liver tissue, and. 0.82 ppm sulfadimethoxine in muscle tissue.

On or about August. 28, 2006, you sold to [redacted] a dairy cow identified with your ear tag #488 and cross-referenced to back tag #5327 for slaughter as food. On or about August 29, 2006, this animal was slaughtered at [redacted].The USDA/FSIS analysis of tissue samples collected from that animal identified the presence of 0.11 ppm ampicillin in kidney tissue.

On or about September 7, 2006, you sold to [redacted] a dairy cow identified with your ear tag #881 and cross-referenced to back tag #5828 for slaughter as food. On or about September 7, 2006, this animal was slaughtered at [redacted]. The USDA/FSIS analysis of tissue samples collected from that animal identified the presence of 20.98 ppm oxytetracycline in kidney tissue, 6.97 ppm sulfadimethoxine in liver tissue, and 3.88 ppm sulfadimethoxine in muscle tissue.

A tolerance of 12 ppm has been established for residues of oxytetracycline in kidney tissues of cattle as codified in Title 21, Code of Federal Regulations, 556.500 {21 CFR 556.500). A tolerance of 0.01 ppm has been established for residues of ampicillin in uncooked edible tissues of cattle as codified in 21 CFR 556.40. A tolerance of 0.1 ppm has been established for residues of sulfadimethoxine in uncooked edible tissue of cattle as codified in 21 CFR 556.640. The presence of these drugs in excess of these amounts in these tissues from these animals 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)] of the Act.

Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. You lack an adequate system to ensure 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. For example, you failed to maintain in your treatment records a reliable system to ensure that treated cattle are not culled before labeled meat and milk withhold times are met. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) [21 U.S.C. 342(a){4)] of the Act.

In addition, you adulterated sulfadimethoxine, oxytetracycline hydrochloride, penicillin G procaine, amoxicillin, and isoflupredone acetate within the meaning of section 501(a)(5) [21 U.S.C. 351(a)(5)]. of the Act when you failed to use these drugs in conformance with their approved labeling. "Extralabel use," i:e., the actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling, 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. The extralabel use of approved veterinary or human drugs must comply with sections 512(a)(4) [21 U.S.C. 360b(a)(4)] and 512(a)(5) [21 U.S.C.360b(a)(5)] of the Act and 21 CFR Part 530. Our investigation found that your extralabel use of sulfadimethoxine, oxytetracycline hydrochloride, penicillin G procaine, amoxicillin, and isoflupredone acetate failed to comply with these requirements.

For example, you administered the sulfadimethoxine to treat an indication (mastitis} not set forth in the approved labeling, and you failed to follow the labeled slaughter withdrawal time. Sulfadimethoxine is prohibited from extralabel use in food producing animals by 21 CFR 530.41(a)(9). In addition, you administered oxytetracycline hydrochloride without following the animal class set forth in the approved labeling, you administered penicillin G procaine without following the dosage amount per injection site and for an indication (metritis) that is not set, forth in the approved labeling, and you failed to observe the slaughter withdrawal time for animals treated with amoxicillin. Furthermore, you failed to follow the extralabel use directions for the route of administration of isoflupredone acetate prescribed by your veterinarian.

Your use of sulfadimethoxine in an extralabel manner, when such use is prohibited by 21 CFR 530.41(a)(9), caused the drug to be unsafe under section 512(a) [21 U.S.C. 360b(a)] of the Act. In addition, your extralabel use of oxytetracycline hydrochloride, penicillin G procaine, amoxicillin, and isoflupredone acetate was without the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). Furthermore, your extralabel use of sulfadimethoxine; oxytetracycline, and ampicillin resulted in drug residues above an established safe level, safe concentration, or tolerance, in violation of 21 CFR 530.11(d). Because your extralabel use of these drugs was not in compliance with 21 CFR Part 530, your use caused the drugs to be unsafe under section 512(a) [21 U.S.C. 360b(a)] of the Act and adulterated within the meaning of section 501(a)(5) [21 U.S.C. 351(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 ensuring that your overall operation and the food 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 notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken 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 response should be sent to, Brian D. Garthwaite, Ph.D., Compliance Officer, at the address located on the letterhead. If you have any questions about this letter, please contact Dr. Garthwaite at (612) 758-7132.



W. Charles Becoat
Minneapolis District


A ProMED-mail post

ProMED-mail is a program of the
International Society for Infectious Diseases

Date: Sat 10 March 2007
From: Mary Marshall
Source: The (Champaign-Urbana, Il) [edited]

Proximity between chimpanzees and people in a protected wildlife area
in Uganda may be leaving them with more in common than an ancestor in
the distant past. The animals also are apparently picking up human
bacteria -- some of them with antibiotic resistance, according to a
University of Illinois (UI) study.

The study in Uganda's Kibale National Park is the 1st to show such a
transmission in a protected wildlife area and without direct contact
between the animals and people, UI Professor Tony Goldberg said
recently. "I think the bottom line is maybe we should be more
concerned than we have been," said Goldberg, a veterinary
pathobiology professor in the UI College of Veterinary Medicine and
principal investigator of the study. "We should be aware of the risk
of infectious disease transmission, probably both ways."

Indeed, some of the most prominent infectious diseases to emerge
recently are believed to have jumped from animals to humans, HIV,
Ebola, and bird flu among them. Chimpanzees in some areas have
likewise exhibited signs of polio-like disease, and gorillas of
measles and mumps.

Diseases spread to humans can travel fast today as well, as fast as
an airliner can fly from Africa to Chicago, for instance.
"Diseases like SARS show how quickly a global epidemic can spread,"
said Goldberg, a leader in tracking the spread of pathogens by
studying their genetic makeup. Goldberg said the new study also
raises concern about the ease with which antibiotic resistance may be
transmitted, to wildlife in particular. The burgeoning of resistant
pathogens already is a human health threat, rendering commonly used
antibiotics ineffective in some cases.

But the spread of resistance has been thought to be largely a result
of such developed-nation problems as over-prescription of antibiotics
by doctors and widespread use of antibiotics in domestic animal feed.

To do the study, the UI researchers, working with colleagues from
Makerere University in Uganda and McGill University in Canada,
examined 2 of the communities of chimpanzees living in the Kibale
park. One of them has been under study by scientists for more than 2
decades. The other is visited regularly by ranger guides who shepherd
tourists in the park. The researchers collected samples of _E. coli_
bacteria from the chimpanzees and from the human scientists and
guides. They also collected samples of _E. coli_ from villagers who
live about 3 and 15 miles (5-24 km.) from the park and have little if
any contact with the chimps.

Goldberg said the researchers looked at _E. coli_ because the
bacterium is a good model system for such a study. It's common in
animals and humans and it can be a serious health threat in some
forms. Scientists also know much about _E. coli_ on a molecular,
genetic level -- more than any other bacterium -- and about
antibiotic resistance in _E. coli_. That's important because the UI
researchers and their colleagues basically compared the genetic
fingerprints of the various samples to see if there were
similarities. They found that _E. coli_ from people who worked in
proximity to the chimpanzees was more like the _E. coli_ from the
chimps than bacteria from the villagers who have little or no contact
with the animals.

Goldberg said you might expect some limited "background level" of
antibiotic resistance in the chimps from natural factors. But in this
case, specific strains of resistance proved to be significantly
similar among the animals and the people who work with them. While
antibiotics are used frequently among humans in the area, they've
never been used in the local wildlife, indicating that the resistance
found in the chimpanzees jumped from people, he said. And that's
without the 2 actually touching. Goldberg said the transmission
probably occurred environmentally, through contact by each with water
sources and the like. He said the findings have prompted the
researchers, who already took precautions to avoid contact, to be
even more careful. Another goal of the study is to provide the
Ugandans who manage Kibale with information they can use to minimize
the human impact on the wildlife there, through measures such as
limiting the number of people in the park and the time they spend in it.

The researchers are now looking for similarities in bacteria and
antibiotic resistance in people from farms around the park whose
crops are raided by Kibale chimpanzees and other monkeys.

The study was funded by the Morris Animal Foundation, which aims to
improve the health and well being of companion animals and wildlife
by funding humane health studies and disseminating information about
the results. Goldberg said it is the 1st in a series of studies
looking at health, disease transmission, and conservation involving
humans, primates, and domestic animals under the Kibale EcoHealth Project.

The project, headed by Goldberg and UI Professor Thomas Gillespie, is
associated with the UI Earth and Society Initiative, an
interdisciplinary program to address compelling environmental
questions, particularly as they relate to human health and societal well being.

[Byline: Greg Kline]


[A map of Uganda indicating the location of Kibale National Park is
available at
. - CopyEd.MJ]

Date: Sat 10 Mar 2007
From: William B. Karesh

The newspaper article does not make it clear if the direction of
transmission of the infectious organisms was conclusively proven in
this study, but we have long known about anthropozoonootic
infections. Human tuberculosis, measles, and polio being 3 notable
human diseases which have been found to kill apes and other pathogens
such as _Salmonella_ ssp, _Cryptosporidium parvum_, _Sarcoptes
scabiei_, and _Giardia duodenalis_ have been described as being found
in animals with humans implicated as the source species. Thaddeus
Graczyk has done some interesting work over the years in this subject
and also described the ability of a myriad of fly species able to
facilitate the long-distance spread of organisms shed in human feces.

As the authors note, one must be careful when interpreting antibiotic
resistance in bacteria. Antibiotics exist (and were originally
discovered) in nature, providing protection to the molds, fungi, and
plants that produce them. In turn, bacteria have developed antibiotic
resistance long before the advent of pharmaceuticals.

William B. Karesh, D.V.M.
Co-chair, IUCN Species Survival Commission - Veterinary Specialist Group
Director, Field Veterinary Program
Wildlife Conservation Society
2300 Southern Blvd.
Bronx, NY 10460

[Humans studying chimp bands may find themselves far from base when
they need to defecate, so they do it in the bush. Flies can become
contaminated with fecal bacteria from there and spread them to
chimps. - Mod.MHJ, JW]

[Generally, a zoonosis is defined as a disease of animals that is
transmissible to humans. Some authors, however, have split the
concept into zooanthroponosis, infections humans can acquire from
animals, and anthropozoonosis, a disease of humans transmissible to
other animals -- also called a "reverse zoonosis".

The closeness of humans and animals in the wild, in a zoological
garden, or in a home can facilitate such reverse zoonoses. An example
of a classical infection of man that can be such a disease is
tuberculosis. _Mycobacterium tuberculosis_ has been spread to
primates (1), elephants (2), and dogs (3).

1. Michel AL, Huchzermeyer HF: The zoonotic importance of
_Mycobacterium tuberculosis_: transmission from human to monkey. J S
Afr Vet Assoc 1998;69: 64-5.

2. Mickalak K, Austin C, Diesel S, et al: _Mycobacterium
tuberculosis_ infection as a zoonotic disease: transmission between
human and elephants. Emerg Infect Dis 1998;4: 283-7.

3. Erwin PC, Benis DA, Mawby DJ, et al: _Mycobacterium tuberculosis_
transmission from human to canine. Emerg Infect Dis 2004;10: 2258-60. - Mod.LL]

This topic is an important discussion and I am glad we have assembled
several comments. I am very grateful for Billy Karesh's comments
above and his consistent contributions to ProMED-mail. I also want to
point out a very interesting paper by Mark Woolhouse and Sonya
Gowtage-Sequeria published in the EID (Emerging Infectious Diseases)
journal in December 2005 and referenced below.

The paper is titled "Host range and emerging and reemerging
pathogens". The authors surveyed the literature, including
ProMED-mail archives, and determined that there are 1407 species of
human pathogens, 58 percent of which are zoonotic. They also
identified 177 emerging and re-emerging diseases, of which 73 percent
are known to be zoonotic. The pattern differed somewhat across the
various pathogen groups of viruses and prions, bacteria and fungi,
protozoa and helminths. Bacteria and fungi are most likely to be
zoonotic, which is somewhat surprising given the attention viruses
receive in the world of emerging diseases.

Since 1959, WHO (World Health Organization) has defined zoonoses as
the "those diseases and infections which are naturally transmitted
between vertebrate animals and man". However, a major PAHO (Pan
American Health Organization) publication on zoonotic diseases by
Acha and Szyfres, "Zoonoses and communicable diseases common to man
and animals" differs slightly on the subject indicating that the book
"considers 2 groups of communicable diseases: those transmitted from
vertebrate animals to man, which are "strictly speaking" zoonoses;
and those common to man and animals". Jim Steele who has, for the
past 75 years, been steeped in the study and prevention of zoonotic
disease, both cites the WHO definition and utilizes the notion of
diseases that are common to man and animals in his CRC Handbook of
the Zoonoses series. Schwabe, in Veterinary Medicine and Human
Health, discuses the multiple definitions in detail and proposes the
notion that zoonoses are those infections that are shared in nature.

These multiple definitions of zoonoses, and their directional
subcategories, correctly given by Mod.LL above, result in a certain
amount of obfuscation concerning the essential nature of zoonotic
diseases. The emphasis should not be placed on directionality of
infection but on the natural pattern of occurrence and potential
manipulable risk factors, regardless of in which direction the
disease travels. Whether it goes from animals to humans or, as in
this case of antibiotic resistance in chimpanzees, the other way
around, key epidemiologic factors such as close proximity,
commonality of food and water, or other risk factors must be
uncovered. It is critical that appropriate behavior and/or management
of the transmitting and receiving species be ensured to prevent the
occurrence of disease transmission.

Certainly, work by people like Professor Goldberg, Billy Karesh, and
Gladys Kalema-Zikukosa, (whose non-profit Conservation through Public
Health works in Uganda on these issues) provides us with a view from
the other side of the zoonotic equation or more properly put, another
angle to look from when viewing the zoonotic disease web. This is
extremely valuable because the more we know about how chimpanzees get
sick, the more we know about transmission of disease between host
species in its entirety, the better we can both protect public health
and conserve animal health and well being. Obviously, it is important
to do both to the best of our abilities, yet the study of diseases
flowing from humans to animals is undertaken infrequently.

1. Woolhouse MEJ, Gowtage-Sequeria S: Host range and emerging and
reemerging pathogens. Emerg Infect Dis [serial on the Internet]. 2005
Dec [13 March 2007], available at

2. Veterinary Medicine and Human Health. CW Schwabe (Williams &
Wilkins, Baltimore, 1984).

3. Acha PN, Szyfres B: Zoonoses and communicable diseases common to
man and animals. 3rd edition, (Pan American Health Organization,
Washington, DC, 2001, 2003), available from PAHO at .

4. CRC Handbook of Zoonoses. JH Steele and G Beran Eds. CRC Press,
ISBN 9780849332067.
- Mod.PC]

[see also:
Respiratory infections, fatal, gorillas - Africa 20050715.2019
Scabies, chimpanzees - Tanzania (Gombe Nat. Park) (02) 19971224.2542
Scabies, chimpanzees - Tanzania (Gombe National Park) 19971219.2509]

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. ...END

Date: Mon, 10 Mar 2003 15:41:55 -0600
From: "Terry S. Singeltary Sr."

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.



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