Wednesday, April 14, 2010

FSIS National Residue Program for Cattle Audit Report 24601-08-KC March 2010

U.S. Department of Agriculture Office of Inspector General

Audit Report 24601-08-KC March 2010

FSIS National Residue Program for Cattle

U.S. Department of Agriculture Office of Inspector General Washington, D.C. 20250

DATE: March 25, 2010

REPLY TO ATTN OF: 24601-08-KC

TO: Alfred V. Almanza Administrator Food Safety and Inspection Service

ATTN: William C. Smith Assistant Administrator Office of Program Evaluation, Enforcement and Review FROM: Gil H. Harden /s/ Acting Assistant Inspector General for Audit

SUBJECT: FSIS National Residue Program for Cattle

This report presents the results of our audit concerning FSIS management of the national residue program, especially as it relates to cattle. Your response to the official draft report, dated March 2, 2010, is included at the end of the report. Excerpts of the response, along with Office of Inspector General’s position, are incorporated into the Findings and Recommendations section of the report. Based on your responses, we were able to reach management decision on all of the report’s 14 recommendations. Please follow your agency’s internal procedures in forwarding documentation for final action to the Office of the Chief Financial Officer.

We appreciate the courtesies and cooperation extended to us by members of your staff during this audit.

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FSIS National Residue Program for Cattle

Executive Summary

One of the public food safety issues facing the United States is the contamination of meat with residual veterinary drugs, pesticides, and heavy metals. “Residue” of this sort finds its way into the food supply when producers bring animals to slaughter plants while they have these residual contaminants in their system. When the animals are slaughtered, traces of the drugs or pesticides contained in these animals’ meat is shipped to meat processors and retail supermarkets, and eventually purchased by consumers. In order to safeguard the Nation’s food supply from harmful residue, the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) administers the national residue program. FSIS inspectors sample meat processed through slaughter plants for residue testing and compare the results with tolerances established by the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) to prevent adulterated meat from entering into commerce.2 The Office of Inspector General (OIG) initiated this audit to evaluate the effectiveness of the national residue program and to assess how well FSIS, FDA, and EPA were coordinating to accomplish the program’s objectives.

Based on our review, we found that the national residue program is not accomplishing its mission of monitoring the food supply for harmful residues. Together, FSIS, FDA, and EPA have not established thresholds for many dangerous substances (e.g., copper or dioxin3), which has resulted in meat with these substances being distributed in commerce. Additionally, FSIS does not attempt to recall meat, even when its tests have confirmed the excessive presence of veterinary drugs.

To address these serious shortcomings in the national residue program, FSIS, EPA, and FDA need to take steps to improve how they coordinate with one another to accomplish the program’s mission. Recognizing that they needed to work together to prevent residue from entering the food supply, the three agencies established the Surveillance Advisory Team (SAT) and the Interagency Residue Control Group (IRCG) as a way of coming together to communicate and coordinate.4 We found, however, that there were a wide range of problems with relying on this process: not all agencies were equally committed to the SAT and IRCG; essential participants were not required to attend; and no one agency had authority to ensure that necessary actions were taken to deal with disagreements. Due to problems with how the SAT and IRCG were established and were functioning, we identified four issues relating to coordination between FSIS, EPA, and FDA. The three agencies involved need to: 1) expand the substances they test

1 Pesticides are any substance intended for preventing, destroying, repelling, or mitigating any pest (e.g., insects or mice) or any substance intended for use as a plant regulator, defoliant, or desiccant. 2 When violative levels of residues are detected in food-producing animals submitted for slaughter, the product found to be contaminated with violative residues is considered “adulterated” and is subject to condemnation and disposal. If the product has already been released into commerce, then FSIS evaluates the hazard the product poses to the public and, based on this analysis, determines whether to request a product recall by the firm that manufactured the adulterated product. 3 Dioxins are formed as a result of combustion processes, such as waste incineration and the burning of fuels (e.g., wood, coal, or oil). Exposure to large amounts of dioxins may cause skin diseases, mild liver damage, cancer, reproductive problems, or developmental effects. 4 The SAT meets annually with the primary function of establishing the sampling plan for the national residue program’s scheduled sampling for the next year. The IRCG meets monthly to address ongoing issues concerning the national residue program.

Audit Report 24601-08-KC

for, 2) improve their methodology for sampling hazardous residues, 3) determine more efficient ways of approving newer methods of testing for drug residues, and 4) collaborate to set tolerances for additional residues.

FSIS, EPA, and FDA Need to Expand the Substances They Test For

Each year, the SAT brings together representatives from FSIS, EPA, and FDA to decide which residues they will include in the approximately 120 substances they test for annually. Although EPA routinely asks FSIS to test for pesticides that the three agencies have together determined to be high health risks, FSIS has, for many years, continued to test for only one type of pesticide, citing its limited resources and the fact that EPA has not established tolerances for

Audit Report 24601-08-KC

2

many varieties of pesticides.

We acknowledge that FSIS’ laboratory testing resources are not unlimited and that the agency must make decisions about what it will and will not test for. However, if EPA, FDA, and FSIS determine that there are additional high risk substances that should be tested, the SAT needs a mechanism for resolving differences and, if necessary, obtaining necessary testing resources. One such mechanism would be to elevate such disagreements to executive-level officials capable of arriving at an appropriate compromise. A 1984 memorandum of understanding to coordinate Federal residue monitoring activities was signed by the FSIS Administrator and other officials at FDA and EPA below the Administrator’s level. We believe that residue monitoring is of such importance that the framework of the program should be re-established and approved at the highest levels within the respective Departments.

FSIS, FDA, and EPA Need to Improve Their Methodology for Sampling Hazardous Residues

Once the three agencies involved have determined which substances they will test for, they then decide how they will sample for those substances. We found, however, that different groups have questioned FSIS’ sampling methodology, both its sample size and design. For example, FSIS laboratory personnel believe that they should be testing more than 300 samples for some residues, while an outside contractor performing a quality control review recommended that FSIS could test fewer samples “without a significant loss in precision.” Members of the SAT and IRCG have also proposed that sampling for some veterinary drugs quarterly instead of monthly would provide equally useful information and could also save laboratory resources.

The SAT is the appropriate forum for discussing issues concerning FSIS’ sample design, but at present, the appropriate agency managers and personnel with the relevant qualifications do not always attend SAT meetings, and the agencies have not conducted a thorough review of how they design the sample for these substances. The three agencies should work together to strike a balance between sampling demands, resource limitations, and the relative importance of any given compound. Following appropriate risk analysis principles would provide FSIS with a scientific and structured approach that would also allow the agency to optimize its limited laboratory resources. FSIS and FDA Need to Determine More Efficient Ways of Approving Newer Methods of Testing for Drug Residues

When testing for the various types of drug residue that the agencies have determined to be high risk, FSIS relies on FDA to approve the testing methods it uses. However, the approved methods are often antiquated and ineffective because they were approved when FDA first approved the drug. “Bridging” testing methods—confirming that a newer and more efficient method will yield acceptable results when compared to the FDA-approved method—is a slow and difficult process, and FDA is not always willing, or able, to undertake the work.

Although FDA and FSIS disagree on how to solve this problem, they agree that until the problem is resolved, FSIS will not be able to test for residues as efficiently as possible. FSIS and FDA should cooperate to improve their efficiency in approving newer methods for FSIS to use in testing for residues, as doing so will enable FSIS to take advantage of advanced technologies, lower its costs, and improve the quality of its analyses.

FSIS, EPA, and FDA Need to Collaborate to Set Tolerances for Additional Residues

If FSIS confirms the presence of residue in a sample of meat, it needs a “tolerance” or a threshold for determining if the concentration of that residue is dangerous for human consumption. For example, FDA has set a tolerance of .05 parts per million for penicillin in beef, so FSIS knows that beef with 10.62 parts per million should be excluded from the food supply. FSIS relies on FDA or EPA to set tolerances for drugs, pesticides, and heavy metals.

We found, however, that tolerances have not been set for many potentially harmful substances, which can impair FSIS’ enforcement activities. For example, in 2008, when Mexican authorities rejected a shipment of U.S. beef because it contained copper in excess of Mexico’s tolerances, FSIS had no basis to stop distribution of this meat in the United States since FDA has set no tolerance for copper. Though we acknowledge that setting tolerances is an expensive and time-consuming process, FSIS needs a systematic and formal process to request FDA and EPA to set tolerances for residues that are deemed potentially hazardous. FSIS also needs procedures that specify what actions agency personnel are to take regarding the disposition of carcasses that contain potentially hazardous substances when there are no formal tolerances established by EPA or FDA.

Along with the issues of coordination among the three agencies involved in the national residue program, we found that FSIS itself can take action to strengthen the program by requiring slaughter plants to increase their controls when processing dairy cows and bob veal.

Audit Report 24601-08-KC 3

5 Plants handling dairy cows and bob veal were, in 2008, responsible for over 90 percent of residue violations found. FSIS allowed such plants to continue treating residue problems as “not reasonably likely to occur”—the determination that would allow plants to justify not implementing additional procedures to control residues. Although FSIS had reviewed these plants’ control plans multiple times, agency officials explained that they had not done the analysis to determine that violations were so concentrated among dairy cows and bob veal. As a result, in 2008, individual plants amassed as many as 211 violations—with 21 producers having

5

Bob veal are calves, usually unwanted male calves born at dairy operations, that are slaughtered within a few days of birth.

multiple violations—and still were able to treat residue as a problem “not reasonably likely to occur.” FSIS has had a longstanding problem of not being able to identify the producers of cattle that have tested positive for residue, as dairy cows often pass through several buyers and sellers before they are presented for slaughter by suppliers. Without this information, FSIS will always be limited in its ability to respond to repeat violators and to prevent such cattle from entering the slaughter plants. In order to resolve this problem, it would be in FSIS’ interest to require that plants with a history of residue violations identify the producers of any animals presented for slaughter, so that plants can take proactive measures to prevent or control shipments of cattle at high risk for residues and FSIS can subject the animals to additional testing.

Audit Report 24601-08-KC 4

6 However, FSIS officials explained that the Agency does not have the authority to require plants to obtain producer identification for animals arriving for slaughter.7 As an alternative to obtaining the authority to request producer identification, FSIS should establish procedures that provide incentives for the plants with a history of residue violations to voluntarily request producer’s identification for any animal presented for slaughter, such as subjecting every shipment of cattle from unknown producers to additional on-site screening for potential residue testing. Additionally, since FSIS already maintains repeat violator information, it should establish performance measures, such as tracking reductions in the occurrence of repeat residue violations over time.

We also found that FSIS does not recall meat adulterated with harmful residue, even when it is aware that the meat has failed its laboratory tests. Between July 12, 2007, and March 11, 2008, FSIS found that four carcasses were adulterated with violative levels of veterinary drugs8 and that the plants involved had released the meat into the food supply. Although the drugs involved could result in stomach, nerve, or skin problems for consumers, FSIS requested no recall. Officials explained that when meat enters commerce, the agency must prove that consuming a single serving of the contaminated meat is likely to cause harm. In these cases, FSIS determined that consumers would not likely be “acutely harmed” by consuming a single serving of this meat so it could be difficult to force a plant to implement a voluntary recall. In addition, FSIS faces the task of convincing a U.S. Attorney to file for the product seizure in federal district court if the plant refuses the voluntary recall. According to FSIS officials, seizure of the product is not likely for non-acute health risks, e.g., a small amount of residue adulterated product from a single carcass. However, in the past, FSIS has requested plants initiate voluntary Class II recalls for “low” risk health situations for non-acute causes, such as distribution of product that was produced from animals that had not received a proper ante-mortem inspection.

Finally, we found that FSIS needs to modernize its process for sampling carcasses at slaughter plants and then testing those samples at its laboratories so that the agency can make use of readily available technologies, including barcode scanning, electronic forms for retaining information, and an electronic reservation system for scheduling tests. At present, the agency

6

This additional testing was recently required by FSIS publication of Notice 04-09, in January, 2009.

7

FSIS does have the authority to require producer identification for producers bringing bob veal into slaughter under 9 Code of Federal Regulations 309.16(d)(2), which states that “[t]he identity of the producer of each calf presented for ante-mortem inspection shall be made available by the official establishment to the inspection [inspector] prior to the animal being presented for ante-mortem inspection.”

8

These drugs were Ivermectin, Sulfadimethoxine, Florfenicol, and Sulfamethazine, which are anti-parasitic or anti-bacterial agents.

relies on a system that requires employees to make pen and paper notes on tags that are affixed to carcasses—a system that is slow, cumbersome, and not always very legible. FSIS officials stated that they did not realize their technology was out-of-date and did not know that some plants were already using newer and more innovative techniques for tracking carcasses. Due to this problem, FSIS’ public health veterinarians had less time to devote to their primary mission of inspecting and testing animal carcasses for harmful adulterants, and FSIS was testing meat samples for residue less efficiently and reliably than was necessary. We concluded that FSIS—both alone and in collaboration with FDA and EPA—needs to take a number of important steps to strengthen the national residue program. Those steps should ensure that the program is effectively accomplishing its objectives of ensuring that adulterated meat is not entering the U.S. food supply.

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Background & Objectives

Background

As the public health agency of USDA, FSIS administers the national residue program to ensure that the Nation’s food supply is safe from the residues of veterinary drugs, pesticides, and heavy metals that might find their way into meat destined for human consumption.

The effects of these residues on human beings who consume such meat are a growing concern. Not only does overuse of antibiotics help create antibiotic-resistant strains of diseases, but the residues of certain drugs and heavy metals can have potentially adverse health consequences if they are consumed in meat. The following table shows five drugs or substances and the potential side effects or health consequences:

DRUG OR SUBSTANCE POTENTIAL SIDE EFFECTS

Flunixin Fecal blood, gastrointestinal erosions and ulcers, and renal necrosis.

Penicillin Life-threatening allergic reaction (i.e., difficulty breathing, closing of the throat); serious nerve damage; severe inflammation of the colon; swelling of the lips, tongue, or face; bleeding; and diarrhea.

Arsenic Nonmalignant skin lesions, skin malignancy, internal malignancies, vascular diseases, and hypertension.

Copper Hemolysis, jaundice, changes in lipid profile, oxidative stress, renal dysfunction, and even death.

Ivermectin Neurotoxicity (e.g., altering normal activity of the nervous system which can eventually disrupt or even kill neurons, key cells that transmit and process signals from the brain).

Residues of drugs, pesticides, and heavy metals differ from microbiological pathogens like E. coli,11 Salmonella, and Listeria Monocytogenes, which the public more readily associates with food safety. While cooking meat properly can destroy these pathogens before they are consumed, no amount of cooking will destroy residues. In some cases, heat may actually break residues down into components that are more harmful to consumers. Since consumers have no easy way of protecting themselves against the residues of harmful substances in their food, it is important that the national residue program’s controls be as robust as possible to prevent meat contaminated with harmful substances from reaching the kitchen table.

11

For purposes of this report, we refer to Escherichia coli O157:H7 simply as E. coli.

Audit Report 24601-08-KC 8

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Section 2: FSIS Needs to Strengthen Oversight at Plants and Upgrade the National Residue Program’s Technology

Finding 2: FSIS Needs to Strengthen Oversight of the National Residue Program, Especially at Plants Slaughtering Dairy Cows and Bob Veal

FSIS has not required that slaughter plants processing dairy cows and bob veal implement adequate controls to ensure that residue is not entering the food supply, even though these plants are at much higher risk than plants processing beef cattle. This has occurred because Hazard Analysis and Critical Control Point (HACCP) principles allow slaughter plants themselves to make the determination as to whether residue problems were “reasonably likely to occur”—the threshold for implementing additional controls—and the primary function of the FSIS plant-level personnel is not to challenge the hazardous risk assessment but to verify or monitor the plant’s application of the existing controls. FSIS did not exercise additional oversight despite the fact that plants handling dairy cows and bob veal were responsible for over 90 percent of residue violations in 2008.

Audit Report 24601-08-KC 24

33 Agency officials had not performed the analysis necessary to determine that violations were concentrated within dairy cows and bob veal, and they regard residue as a lower priority than other sorts of adulterants, such as E. coli and Salmonella. As a result, in 2008, one plant amassed as many as 211 violations—another had 21 producers with multiple violations—and other plants treated residue as a problem “not reasonably likely to occur” (see Table 1, below). Furthermore, we verified that at least four beef carcasses were adulterated with violative levels of residue, entered commerce, and were not recalled by the slaughter plant or FSIS.34

The following table summarizes the number of residue violations at 7 selected cattle slaughter establishments during the 2008 calendar year. The violation data was taken from the Residue Violation Information System (RVIS).35 This information includes OIG’s assigned plant identification number (1 – 7), the number of residue violations at each plant, the number of repeat offenders that delivered cattle to the plant, the number of residue violations that occurred at the plant from repeat offenders, and the overall percentage of residue violations at the plant that came from repeat offenders.

33

The 2008 data from the RVIS database was the most recent full calendar year information available at the time of our field work.

34

Since FSIS did not request a voluntary recall by the establishments, the plants did not collect the production data necessary for FSIS to determine the number of pounds of product from the four carcasses with the violative amounts of Ivermectin, Sulfadimethoxine, Florfenicol, and Sulfamethazine.

35

During the course of our audit, we did not verify information in the RVIS, and make no representation of the adequacy of the system or the information generated from it.

PLANT VIOLATIONS REPEAT OFFENDERS VIOLATIONS FROM REPEAT OFFENDERS PERCENT OF VIOLATIONS FROM REPEAT OFFENDERS

1 211 12 24 11 percent

2 196 21 57 29 percent

3 102 6 14 14 percent

4 90 9 22 24 percent

5 58 1 2 3 percent

6 50 3 6 12 percent

7 42 7 17 40 percent

see full text ;

http://www.usda.gov/oig/webdocs/24601-08-KC.pdf


EXAMPLE ;

1008 Grinstead Mill Road Dairy

Department of Health and Human Services Public Health Service Food and Drug Administration

March 15, 2010

VIA FEDERAL EXPRESS

WARNING LETTER 10-89924-08

Mr. Kelly Poynter, Sr., Owner 1008 Grinstead Mill Road Cave City, Kentucky 42127-9601

Dear Mr. Poynter:

On October 6, 7, 8, 13, and 14, 2009, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 1008 Grinstead Mill Road, Cave City, Kentucky 42127-9601. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the Act and its associated regulations on the Internet through links on FDA's web page at www.fda.gov.

We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the Act, 21 U.S.C. 360b. Further, under section 402(a)(4) of the Act, 21 U.S.C. 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.

Specifically, our investigation revealed that on or about July 6, 2009, you sold a culled dairy cow, identified with back tag (b)(4) for slaughter as food. On or about July 7, 2009, (b)(4) slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 35.936 parts per million (ppm) of sulfamethazine residue in the muscle tissue and the presence of 32.294 ppm of sulfamethazine residue in the liver tissue. FDA has established a tolerance of 0.1 ppm for residues of sulfamethazine in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.670 (21 C.F.R. 556.670). The presence of this drug in edible tissue from this animal in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. 342(a)(2)(C)(ii).

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. For example, you failed to maintain treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. 342(a)(4).

We also found that you adulterated the new animal drug sulfamethazine. Specifically, our investigation revealed that you did not use sulfamethazine as directed by its approved labeling. Use of this drug in this manner is an extra-label use. See 21 C.F.R. 530.3(a). In addition, the extra-label use of sulfamethazine is prohibited in lactating dairy cows under 21 C.F.R. 530.41(a)(9).

The extra-label use of approved new animal or human drugs in animals is allowed under the Act only if the extra-label use complies with sections 512(a)(4) and (5) of the Act, 21 U.S.C. 360b(a)(4) and (5), and 21 C.F.R. Part 530, including 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.

Our investigation found that you administered sulfamethazine to the culled dairy cow identified with back tag (b)(4) without following the dose and withdrawal period as stated in the approved labeling. Sulfamethazine is prohibited for extra-label use in lactating dairy cows by 21 C.F.R. 530.41(a)(9). Furthermore, your extra-label use of sulfamethazine resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused 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. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.

You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these 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 fifteen (15) working days of receiving this letter, 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 written response should be sent to Stephen J. Rabe, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions about this letter, please contact Mr. Rabe at 513-679-2700 ext. 163.

Sincerely, /S/

Karen Gale Sego Acting District Director Cincinnati District

Cc: Dr. William Thorn University of Kentucky Division of Regulatory Service 103 Regulatory Service Building Lexington, KY 40546-0275

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm206359.htm


Methicillin-Resistant Staphylococcus aureus (MRSA) Strain ST398 Is Present in Midwestern U.S. Swine and Swine Workers

Recent research has demonstrated that many swine and swine farmers in the Netherlands and Canada are colonized with MRSA. However, no studies to date have investigated carriage of MRSA among swine and swine farmers in the United States (U.S.).

We sampled the nares of 299 swine and 20 workers from two different production systems in Iowa and Illinois, comprising approximately 87,000 live animals. MRSA isolates were typed by pulsed field gel electrophoresis (PFGE) using SmaI and EagI restriction enzymes, and by multi locus sequence typing (MLST). PCR was used to determine SCCmec type and presence of the pvl gene.

In this pilot study, overall MRSA prevalence in swine was 49% (147/299) and 45% (9/20) in workers. The prevalence of MRSA carriage among production system A's swine varied by age, ranging from 36% (11/30) in adult swine to 100% (60/60) of animals aged 9 and 12 weeks. The prevalence among production system A's workers was 64% (9/14). MRSA was not isolated from production system B's swine or workers. Isolates examined were not typeable by PFGE when SmaI was used, but digestion with EagI revealed that the isolates were clonal and were not related to common human types in Iowa (USA100, USA300, and USA400). MLST documented that the isolates were ST398.

These results show that colonization of swine by MRSA was very common on one swine production system in the midwestern U.S., suggesting that agricultural animals could become an important reservoir for this bacterium. MRSA strain ST398 was the only strain documented on this farm. Further studies are examining carriage rates on additional farms.

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Discussion

This study is the first to document MRSA in U.S. swine and swine workers, and to our knowledge, the first to report the presence of ST398 (also reported as non-typeable MRSA, NT-MRSA) [15] in the U.S. Like previous studies in Canada, Denmark, and the Netherlands [11], [12], [24], ST398 was found in both animals and humans, suggesting transmission between the two. The prevalence of MRSA colonization among swine and swine workers was high at one farm system that we examined in the Midwestern U.S., suggesting that agricultural animals could become an important reservoir for this bacterium. Strain ST398 was the only MRSA identified among the swine and swine workers. This strain has been the predominant strain among swine in the Netherlands and Canada. However, Khanna et al. in Canada recently found both ST398 and ST5/USA100 colonizing the nares of swine and swine workers [12]. This difference may indicate that the epidemiology of MRSA on Canadian swine farms is different than on the affected farm system in Iowa and Illinois. On the other hand, the difference may have resulted from differing sampling methodologies. Khanna et al. sampled a small number of humans and swine on 20 farms whereas we took a larger number of samples from a smaller number of farms in two corporate systems. Furthermore, because we did not type all isolates in this pilot study, additional strain types may be present that we did not detect.

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In summary, we report the first isolation of MRSA from swine and swine workers in the U.S. Although the extent of this problem in the U.S. is currently unknown, our findings may have important implications for the epidemiology of MRSA disease. For example, Van Loo et al. identified MRSA in meat products in the Netherlands [32], suggesting that persons who handle raw pork products might be at risk for acquiring MRSA. Future studies should assess the risk of MRSA disease among swine workers and their contacts, survey retail meat products for MRSA contamination, study larger populations of swine and humans to define the epidemiology of MRSA within swine operations, and assess MRSA carriage rates in other livestock.

full text ;

http://www.plosone.org/article/fetchObjectAttachment.action?uri=info%3Adoi%2F10.1371%2Fjournal.pone.0004258&representation=PDF


also see, and please note ;

"none of the colonized participants reported recent travel to the Dominican Republic. No contact among the different households was reported."

From Emerging Infectious Diseases

Staphylococcus aureus ST398, New York City and Dominican Republic

Meera Bhat; Caroline Dumortier; Barbara S. Taylor; Maureen Miller; Glenny Vasquez; Jose Yunen; Karen Brudney; Jacqueline Sánchez E.; Carlos Rodriguez-Taveras; Rita Rojas; Patricia Leon; Franklin D. Lowy

Authors and Disclosures

Posted: 05/11/2009; Emerging Infectious Diseases © 2008 Centers for Disease Control and Prevention (CDC)

Abstract Closely related Staphylococcus aureus strains of ST398, an animal-associated strain, were identified in samples collected from humans in northern Manhattan, New York, NY, USA, and in the Dominican Republic. A large population in northern Manhattan has close ties to the Dominican Republic, suggesting international transmission.

Introduction

In the past 5 years, as methicillin-resistant Staphylococcus aureus (MRSA) has emerged as a community pathogen, awareness of the role of animal exposure from pets or farming as sources of MRSA has increased.[1-3] We identified a clone of S. aureus previously associated with outbreaks of infections in animals and in humans who work with animals in 2 unique collections of S. aureus isolates. The first was from a population-based study of S. aureus colonization among residents of northern Manhattan in New York, NY, USA; the second was from isolates obtained from the Dominican Republic. This clone does not digest with the restriction enzyme SmaI, which is generally used for pulsed-field gel electrophoresis (PFGE). Consequently, the clone is identified by multilocus sequence typing as sequence type 398 (ST398). Both methicillin-resistant and methicillin-susceptible isolates of S. aureus have been reported.[4] ST398 has been found primarily in Europe, where it has been isolated from pigs and pig farmers in the Netherlands and France and from dogs, pigs, horses, and humans in Germany and Austria.[5-8] Colonization with MRSA ST398 has recently been reported in pigs and pig farmers in Canada.[9]

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The Study

The community-based study was conducted from 2004 through 2007 in the northern section of Manhattan, a borough of New York City. Northern Manhattan contains a large, medically underserved population that has close ties to the Dominican Republic. Participants were recruited by using random-digit dialing. Consenting persons and household members were subsequently interviewed and screened for S. aureus colonization. A total of 321 eligible households containing 914 household members participated. In 9 households, 13 participants were found to be colonized with S. aureus isolates that were SmaI resistant. Digestion with the Cfr9I, an isoschizomer of SmaI, yielded identical PFGE profiles (Figure). Subsequent multilocus sequence typing confirmed the ST398 identification (allelic profile 3-35-19-2-20-26-39). All strains were methicillin susceptible. A representative strain was spa-typed as type t571 (allelic profile 8-16-2-25-2-25-34-25, eGenomics type 109); it was Panton-Valentine leukocidin negative.

Characteristics of persons colonized with ST398 were similar to those of persons in the community-based study and with northern Manhattan census characteristics (Table). The 13 isolates were from 9 different families; 1 family had 4 members colonized with ST398 at either nasal or axillary sites. The mean age of those colonized was 33.4 years; only 1 child (7 years of age) was colonized. Two persons from different families were colonized with ST398 at multiple sites, none of which were confirmed as infections.

No household reported owning pets, although 2 reported animal contact. Of the 12 adults, 5 (41.7%) reported possible job exposure to S. aureus, including 1 who worked in a healthcare-associated field. No household reported patronizing viveros, or live poultry markets, which are common in the Latino communities of northern Manhattan and the Bronx. Two households reported having children who attended day care, although none of these children were colonized with S. aureus. Although 15% of the Dominican population in the study reported travel to the

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Dominican Republic within 6 months of their interview, none of the colonized participants reported recent travel to the Dominican Republic. No contact among the different households was reported.

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http://www.cdc.gov/eid/content/15/2/pdfs/08-0609.pdf


Vancomycin-Resistant Staphylococcus aureus Isolates Associated with Inc18-Like vanA Plasmids in Michigan Wenming Zhu, Nancye C. Clark, Linda K. McDougal, Jeffery Hageman, L. Clifford McDonald, and Jean B. Patel* Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia

Received 11 July 2007/ Returned for modification 11 September 2007/ Accepted 13 November 2007

Vancomycin-Resistant Staphylococcus aureus Isolates Associated with Inc18-Like vanA Plasmids in Michigan

Wenming Zhu, Nancye C. Clark, Linda K. McDougal, Jeffery Hageman, L. Clifford McDonald, and Jean B. Patel* Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia

Received 11 July 2007/ Returned for modification 11 September 2007/ Accepted 13 November 2007

ABSTRACT

Five of the seven cases of vancomycin-resistant Staphylococcus aureus (VRSA) infection identified to date have occurred in southeastern Michigan. VRSA isolates from the four most recent cases (all from Michigan) were characterized. The vanA gene was localized to a single plasmid in each VRSA isolate. The pulsed-field gel electrophoresis patterns of chromosomal DNA and the restriction profile of the plasmid demonstrated that the four isolates were unique and differed from the first three VRSA isolates. Vancomycin-resistant Enterococcus (VRE) isolates, all of which were Enterococcus faecalis, were recovered from case patients 4 to 6. Each VRE isolate transferred vancomycin resistance to E. faecalis JH2-2 by conjugation. PCRs for vanA and the Inc18-like plasmid genes traA and repR confirmed the presence of an Inc18-like vanA plasmid in all VRE isolates and transconjugants. An Inc18-like vanA plasmid was identified in the VRSA isolate from case patient 7. These findings suggest a role of Inc18-like plasmids as vanA donors.

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The occurrence of VRSA appears to be either a one- or a two-step genetic event. The plasmid from the first VRSA isolate was sequenced and was found to be a previously recognized S. aureus plasmid containing a Tn1546 insertion (35). The proposed model of resistance transfer was a two-step genetic event in which the S. aureus isolate acquired the Enterococcus vanA plasmid, Tn1546 transferred from the Enterococcus plasmid to the S. aureus plasmid by transposition, and the Enterococcus plasmid was not maintained in the S. aureus recipient. In the third VRSA case, the entire Enterococcus vanA plasmid was maintained in the S. aureus recipient (36). This suggests a single genetic event in which the vanA plasmid is transferred from one isolate to the next, most likely by conjugation. In our analysis of the Michigan VRSA isolates, both outcomes were observed.

It is not clear how common VRSA will be in the future, but this is certainly a concerning antimicrobial resistance that should be prevented, if possible. An important aspect of VRSA prevention will be the control of VRE and methicillin-resistant S. aureus transmission. This is a challenging prospect, since both VRE and methicillin-resistant S. aureus are endemic in most health care settings in the United States (4). It may be prudent to implement the most rigorous control measures for patient populations and at locations where VRE isolates with Inc18-like plasmids occur.

http://aac.asm.org/cgi/content/full/52/2/452?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=isolates&searchid=1&FIRSTINDEX=2780&sortspec=date&resourcetype=HWFIG



High-Level Vancomycin-Resistant Staphylococcus aureus (VRSA) Associated with a Polymicrobial Biofilm

http://aac.asm.org/cgi/reprint/AAC.00576-06v1.pdf


REVIEW The emergence of vancomycin-intermediate and vancomycin-resistant Staphylococcus aureus P. C. Appelbaum Hershey Medical Center, Hershey, Pennsylvania, USA Corresponding author and reprint requests: P. C. Appelbaum, Department of Pathology, Hershey Medical Center, 500 University Drive, Hershey, PA 17033, USA E-mail: pappelbaum@psu.edu Copyright 2006 European Society of Clinical Microbiology and Infectious Diseases KEYWORDS Antibiotic . methicillin-resistant Staphylococcus aureus . review . vancomycin-non-susceptible Staphylococcus aureus . vancomycin-resistant enterococci Abstract

Methicillin-resistant Staphylococcus aureus (MRSA) is well-recognised as a major cause of infection in the healthcare setting but, even more worryingly, is now emerging in the community. The glycopeptides-notably vancomycin-have traditionally been the mainstay of treatment of MRSA but overuse has led to the emergence of vancomycin-intermediate and vancomycin-resistant MRSA (VISA and VRSA, respectively). Although the mechanisms underlying vancomycin resistance are not yet fully understood, changes to the bacterial cell wall-the site of action of the glycopeptides-are believed to be key. Recent evidence also supports the transfer of genetic material among bacteria as contributing to the development of VRSA. Based on the cases identified to date, risk factors for the development of VRSA may include older age, compromised blood flow to the lower limbs, and the presence of chronic ulcers. The true extent of the problem, however, remains to be determined-it is likely that many cases of VISA and VRSA infection go undetected because of suboptimal screening programmes and possible limitations of automated and non-automated detection methods. Effective screening directed at those patients considered to be most at risk should therefore be a priority. Not surprisingly, the spread of MRSA from the hospital to the community setting, coupled with the emergence of VISA and VRSA, has become a major cause of concern among clinicians and microbiologists. The treatment options available for these infections are now severely compromised and thus new classes of antimicrobial agents effective against MRSA, VISA and VRSA are urgently required.

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DIGITAL OBJECT IDENTIFIER (DOI) 10.1111/j.1469-0691.2006.01344.x About DOI

http://www3.interscience.wiley.com/journal/118633206/abstract?CRETRY=1&SRETRY=0


DOI: 10.3201/eid1604.091435

Suggested citation for this article: Golding GR, Bryden L, Levett PN, McDonald RR, Wong A, Wylie J, et al.

Livestock-associated methicillin-resistant Staphylococcus aureus sequence type 398 in humans, Canada.

Emerg Infect Dis; [Epub ahead of print]

Livestock-associated Methicillin-Resistant Staphylococcus aureus Sequence Type 398 in Humans, Canada

George R. Golding, Louis Bryden, Paul N. Levett, Ryan R. McDonald, Alice Wong, John Wylie, Morag R. Graham, Shaun Tyler, Gary Van Domselaar, Andrew E. Simor, Denise Gravel, and Michael R. Mulvey Author affiliations: National Microbiology Laboratory, Winnipeg, Manitoba, Canada (G.R. Golding, L. Bryden, M.R. Graham, S. Tyler, G. Van Domselaar, M.R. Mulvey); Saskatchewan Disease Control Laboratory, Regina, Saskatchewan, Canada (P.N. Levett, R.R. McDonald); Royal University Hospital, Saskatoon, Saskatchewan, Canada (A. Wong); Cadham Provincial Laboratories, Winnipeg (J. Wylie); Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada (A.E. Simor); and Public Health Agency of Canada, Ottawa, Ontario, Canada (D. Gravel)

Rates of colonization with livestock-associated methicillin-resistant Staphylococcus aureus (MRSA) sequence type 398 have been high for pigs and pig farmers in Canada, but prevalence rates for the general human population are unknown. In this study, 5 LA-MRSA isolates, 4 of which were obtained from skin and soft tissue infections, were identified from 3,687 tested MRSA isolates from persons in Manitoba and Saskatchewan, Canada. Further molecular characterization determined that these isolates all contained staphylococcal cassette chromosome (SCC) mecV, were negative for Panton-Valentine leukocidin, and were closely related by macrorestriction analysis with the restriction enzyme Cfr91. The complete DNA sequence of the SCCmec region from the isolate showed a novel subtype of SCCmecV harboring clustered regularly interspaced short palindromic repeats and associated genes. Although prevalence of livestock-associated MRSA seems to be low for the general population in Canada, recent emergence of infections resulting from this strain is of public health concern.

High prevalence of colonization with livestock-associated (LA) methicillin-resistant Staphylococcus aureus (MRSA) sequence type (ST) 398 among pigs and pig farmers was first

Page 1 of 16

reported in the Netherlands (1) and has since been identified in Canada (2) and the United States (3). In Canada, this LA-MRSA strain was identified in pigs and pig farmers in southwestern Ontario, where prevalence of MRSA colonization was 24.9% (71/285) and 20% (5/25), respectively (2). In the United States, nasal samples from 20 production system workers and 299 swine from 2 farms in Illinois and Iowa showed that 45% (9/20) and 49% (147/299), respectively, were colonized with LA-MRSA (3). Despite such high prevalence of MRSA colonization on these tested farms, to our knowledge, no human or animal infections resulting from LA-MRSA strains have been reported in North America. To determine whether LA-MRSA has recently emerged in the general population of Canada, we identified human infections and colonizations associated with the LA-MRSA strain in Canada and molecularly characterized the isolates. We also identified a novel staphylococcal cassette chromosome (SCC) mecV subtype harboring clustered regularly interspaced short palindromic repeats (CRISPR) and CRISPR-associated genes (cas).

SNIP...

Discussion

The high prevalence of LA-MRSA colonization of pigs and pig farmers in Canada (2) and the United States (3) and this report of human infections suggest that this LA-MRSA strain from Canada poses potential public and occupational health concern in North America. This strain has been associated with various types of infections in pigs (17,18) and humans (19,20) and is transmissible from animal patients to veterinary workers (21), healthcare workers (22), and family members (1). Evidence also suggests that this strain might be spreading from animals to the environment, which may facilitate the colonization or infection of persons who are not involved in animal husbandry (23). Whereas in 2006 in the Netherlands LA-MRSA accounted for >20% of all MRSA isolated (24), carriage of this strain in the general population of 2 provinces in Canada (Manitoba and Saskatchewan) appears rare (0.14%). This difference could be attributed to the substantially higher density of pigs in the Netherlands (1,244 pigs/km2) than in Manitoba (55 pigs/km2), Saskatchewan (6 pigs/km2), and Ontario (91 pigs/km2) (www.agriculture.gov.sk.ca/Pig_Densities). It is also plausible that the much lower proportions of LA-MRSA in Canada, relative to a country with low MRSA endemicity such as the Netherlands, is attributable to competition with other highly successful human epidemic MRSA clones circulating in Canada, including CMRSA2 (USA200/800), CMRSA7 (USA400), and CMRSA10 (USA300) (25,26). The tested LA-MRSA isolates were highly susceptible to most classes of antimicrobial drugs, except ß-lactams and tetracyclines, the latter of which has been attributed to its high usage in animal husbandry (27). The complete sequence of the SCCmec region showed a novel SCCmecV subtype sharing sequence identity in its J1 and J3 regions with chromosomal genes in the S. epidermidis RP62A chromosome (GenBank accession no. CP000029), including a

Page 6 of 16

CRISPR system. CRISPRs and associated cas genes are present in many other bacterial (˜40%) and archaeal (˜90%) genomes (28,29) and have been shown to be involved in sequence-directed immunity against phages (30,31) and plasmids (32). The resistance to plasmids and phages encoded by this system could explain why many of these ST398-MRSA-V strains contain fewer antimicrobial drug resistance genes and phage-encoded virulence factors than do other epidemic MRSA strains (33,34). The origin of this CRISPR system is unknown, but the propagation of CRISPR loci throughout prokaryote genomes has been proposed to occur through horizontal gene transfer by conjugation of megaplasmids >40 kb (35). Because the CRISPR system identified in this study is encoded within a putative mobile genetic element, we propose that an additional mechanism of mobilization to other methicillin-susceptible Staphylococcus spp. is plausible.

This novel subtype of SCCmecV was found in only 4 of the 6 LA-MRSA isolates identified in this study. One isolate not containing this novel SCCmec subtype (08 BA 08100) could also be distinguished by a different but closely related spa type (t1250) (Table 1) and variant PFGE fingerprint (Figure 2) when compared with the other LA-MRSA isolates, which suggests that at least 2 epidemiologically different strains of LA-MRSA circulate in Saskatchewan. The other LA-MRSA isolate that did not contain this novel SCCmec element was obtained in Ontario. However, this isolate was the same spa type (t034) and was closely related, according to PFGE, to the LA-MRSA isolates identified in Saskatchewan. Therefore, in addition to PFGE and spa typing, SCCmec subtyping could provide a useful epidemiologic tool for surveillance, outbreak investigations, or traceability studies of this emerging strain. For detection of this SCCmecV subtype (tentatively designated V.2.1.2; Vb), we propose using primer set 1 (spanning orfX into Sk02 in the J3 region) and primer set 7 (spanning Sk20 into cas1 in the J1 region) (Table 4).

Visual comparison of PFGE fingerprints from this study with those reported from patients from the Dominican Republic and the United States (northern Manhattan, New York, NY) (36), showed substantial variations in fingerprint patterns, as well as related but different spa types. These variations suggest further molecular and geographic diversity of these LA-MRSA strains on a global scale.

Page 7 of 16

Because cases of LA-MRSA infections have only recently been identified in Canada, additional surveillance efforts are required to monitor the emergence and clinical relevance of this MRSA strain in Canada, including communities, the environment, livestock, farmers, and production facility workers. Whether these strains pose a major threat to human health in light of the low livestock density and continued spread of epidemic hospital and community strains of MRSA in Canada remains unknown.

http://www.cdc.gov/eid/content/16/4/pdfs/09-1435.pdf


Volume 16, Number 4–April 2010 Dispatch Porcine-Origin Gentamicin-Resistant Enterococcus faecalis in Humans, Denmark Jesper Larsen, Henrik C. Schønheyder, Camilla H. Lester, Stefan S. Olsen, Lone J. Porsbo, Lourdes Garcia-Migura, Lars B. Jensen, Magne Bisgaard, and Anette M. Hammerum Author affiliations: University of Copenhagen, Frederiksberg, Denmark (J. Larsen, M. Bisgaard); Aarhus University Hospital, Aalborg, Denmark (H.C. Schønheyder); Statens Serum Institut, Copenhagen, Denmark (C.H. Lester, S.S. Olsen, A.M. Hammerum); Technical University of Denmark, Søborg, Denmark (L.J. Porsbo); and Technical University of Denmark, Copenhagen (L. Garcia-Migura, L.B. Jensen)

Suggested citation for this article

Abstract During 2001–2002, high-level gentamicin-resistant (HLGR) Enterococcus faecalis isolates were detected in 2 patients in Denmark who had infective endocarditis and in pigs and pork. Our results demonstrate that these isolates belong to the same clonal group, which suggests that pigs are a source of HLGR E. faecalis infection in humans.

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Conclusions Our study provides evidence of the existence of a widespread community reservoir of HLGR ST16 in pigs in Denmark during 2001–2002, which coincided with emergence of HLGR ST16 isolates among IE patients in North Denmark Region. One isolate was present in pork, which supports foodborne transmission, although direct transmission from animals to humans is also possible.

Our study has potential limitations. First, the method used by DANMAP (susceptibility testing of 1 colony per sample, rather than resistance prevalence per sample) may underestimate the extent of the HLGR reservoir in food-producing animals, meat products, and community-dwelling persons. Second, HLGR isolates from patients with infective endocarditis emanated from 2001 and 2002 and therefore do not represent recent trends.

Our findings support the results of a recent study in the United States that identified HLGR E. faecalis isolates with similar PFGE patterns (<3-band>22 million slaughter pigs (4–6), Denmark has a large potential reservoir of HLGR ST16. Although HLGR ST16 was not detected in other food-producing animals and meat products, this type may not be exclusive to pigs. We found HLGR ST16 isolates in 2 community-dwelling persons during 2003–2005. Preference for eating pork, close contact with the healthcare setting, underlying disease, or a combination thereof may have predisposed these persons to become colonized by this potential pathogen.

HLGR ST16 appears to be transmitted from pigs to humans, although other routes of transmission also may exist. Further studies are needed to better understand the human and veterinary epidemiology of this zoonosis. Areas of study should include recent trends of HLGR among invasive E. faecalis; size of the reservoir in pigs; its association with antimicrobial drug use in pigs; and whether other animals, immunocompromised persons, or healthy persons constitute a community reservoir of HLGR ST16.

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see full text ;

http://www.cdc.gov/eid/content/16/4/682.htm


Animal Sale for Slaughter as Food/Adulterated A few examples ;

Double B Dairy, LLC 3/8/10

Department of Health and Human Services Public Health Service Food and Drug Administration Seattle District Pacific Region 22201 23rd Drive SE Bothell, WA 98021-4421 Telephone: 425-486-8788 FAX: 425-483-4996

March 8, 2010

CERTIFIED MAIL RETURN RECEIPT REQUESTED

In reply refer to Warning Letter SEA 10-17

Joseph F. Brasil, President and Partner Double B Dairy, LLC 2930 South 2300 East Wendell, Idaho 83355

WARNING LETTER

Dear Mr. Brasil:

On January 14, and 20, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 280 West 110 South, Murtaugh, Idaho. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.

We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. § 342(a)(2)(C)(ii), a food is deemed to, be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.

Specifically, our investigation revealed that on or about September 17, 2009, you sold a dairy cow, identified with Back Tag number (b)(4), for slaughter as food to (b)(4) where it was subsequently slaughtered on that same day. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of Flunixin at 1.494 parts per million (ppm) in the liver. FDA has established a tolerance of 0.125 ppm for residues of Flunixin in the edible tissues of cattle, as codified in Title 21, Code of Federal Regulations, Section 556.286 (21 C.F.R. 556.286).

The presence of Flunixin in edible tissues from this animal in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. § 342(a)(2)(C)(ii).

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 records regarding the identity of animal(s) that you delivered for sale to (b)(4). Specifically, your treatment records are correlated to the numbered ear tags that you apply to the individual cows. On or about September 17, 2009, you sold seven cows for slaughter and removed the ear tags prior to them leaving your premises. You failed to correlate the ear tag numbers with back tag numbers, (b)(4) applied by (b)(4) when they picked up the cows and thereby lost the true identity of the cows and the ability to provide treatment records for those individual cows.

Additionally, you failed to have a system to control the administration of drug treatments to your animals. Specifically, it appears that the cow identified by back tag number (b)(4) was administered Banamine (Flunixin meglumine) and the treatment was never recorded. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4).

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http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm204888.htm


Quesnel Livestock 11/23/09

Department of Health and Human Services Public Health Service Food and Drug Administration New England District One Montvale Avenue Stoneham, Massachusetts 02180 (781) 596-7700 FAX: (781) 596-7896

WARNING LETTER

NWE-07-10W

VIA CERTIFIED MAIL RETURN RECEIPT REQUESTED

November 23, 2009

Mr. Bernard Quesnel, Co-Owner Quesnel Livestock 1442 Route 7 North Middlebury, VT 05753-8780

Dear Mr. Quesnel:

An inspection of your operation located in Middlebury, VT, by a Food and Drug Administration investigator on September 22, 2009, September 24, 2009, October 7, 2009 and November 4, 2009, confirmed a dairy cow identified with back tag (b)(4), ear tag # (b)(4), and farm tag (b)(4) purchased and sold by you on or about April 7, 2009, for slaughter for human food to (b)(4), was in violation of Section 402 (a)(2)(C)(ii) of the Federal Food, Drug, and Cosmetic Act (the Act). USDA/FSIS analyses of tissues collected from that animal disclosed the presence of the following drugs:

Date Animal Form Number USDA Case Number Tissue Drug Residue Level Found (ppm) Tolerance 21 CFR Reference Cite 04/08/09 Dairy Cow 343018 09-0371-VT Kidney Liver Penicillin Flunixin 0.60

0.3355 0.05

0.125 556.510

556.286

* Tolerances have been established for residues in the edible tissues of dairy cows which are codified in Title 21 Code of Federal Regulations Section 556.

In addition, USDA has reported the finding of illegal residues in other livestock sold by you and offered for slaughter for human drugs. Copies of letters from USDA/FSIS notifying you of these residues are attached.

Date Animal Form Number USDA Case Number Tissue Drug Residue Level Found (ppm) Tolerance 21 CFR Reference Cite 12/14/06 Dairy Cow 468604 06-0603-VT

07-0066-VT Kidney Penicillin 0.14 0.05 556.510 10/11/06 Bob Veal Calf 109370 06-0906-VT Kidney

Muscle Oxytetracycline 33.52

4.19 12.0

2.00 556.500 08/04/05 Dairy Cow 460745 05-0446-VT Kidney

Liver Penicillin 0.23

0.16 0.05

0.05 556.510 05/06/05 Dairy Cow 460348 05-0446-VT Liver

Muscle Sulfadimethoxine 0.859

1.19 0.10

0.10 556.640 10/08/02 Dairy Cow 446075 02-1302-VT Kidney

Penicillin 0.22 0.05 556.510 03/27/01 Dairy Cow 429987 01-0649-VT Liver

Muscle Sulfadimethoxine 3.40

2.10 0.10

0.10 556.640 06/07/00 Dairy

Cow 406327 00-0052-VT Kidney Penicillin 0.09 0.05 556.510

* Tolerances have been established for residues in the edible tissues of dairy cows which are codified in Title 21 Code of Federal Regulations

In addition, your firm has employed poor husbandry practices by failing to take reasonable precautions to prevent the marketing and sale of animals containing illegal residues in interstate commerce. Your significant violations are as follows:

1. You have failed to implement and maintain a system to identify the animals you purchase with records to establish traceability to the source of the animal. Specifically on or about April 7, 2009 you purchased and sold a cow in interstate commerce, identified with back tag # (b)(4), ear tag # (b)(4), and farm tag # (b)(4), however you maintained no documentation as to the origin of the cow.

2. You have failed to determine from the source of the animal whether the animal has been medicated and with what drug(s). Specifically, since 2000 you have purchased and sold at least (b)(4) livestock animals for slaughter that have been found to contain violative tissue residues. You answered in the negative when asked if you inquire about the medication status of the animal from the source.

Pursuant to section 301(a) {U.S.C. § 331(a)} of the Act the introduction or delivery for introduction into interstate commerce of any food that is adulterated is prohibited.

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http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm192802.htm


Crestview Calves, Inc.

Department of Health and Human Services Public Health Service Food and Drug Administration Seattle District Pacific Region 22201 23rd Drive SE Bothell, WA 98021-4421 Telephone: 425-486-8788 FAX: 425-483-4996

February 16, 2010

CERTIFIED MAIL RETURN RECEIPT REQUESTED /or/ Federal Express

In reply refer to Warning Letter SEA 10-13

Cody G. Morgan; Owner / President Crestview Calves, Inc. 756 South 2800 East Hazelton, Idaho 83335-5280

WARNING LETTER

Dear Mr. Morgan:

On November 3 and 5, 2009, the U.S. Food and Drug Administration (FDA) conducted an investigation of your calf raising operation located at 756 South 2800 East, Hazelton, Idaho 83335-5280. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the Act and its associated regulations on the. Internet through links on FDA's web page at www.fda.gov.

We found that you offered for sale animals for slaughter as food that were adulterated. Under section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the Act, 21 U.S.C. 360b. Further, under section 402(a)(4) of the Act, 21 U.S.C. 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.

Specifically, our investigation revealed that on or about August 14, 2009, you sold a calf, identified with back tag (b)(4), for slaughter as food. On or about August 14, 2009, (b)(4) slaughtered this animal. In addition, our investigation revealed that on or about August 26, 2009, you sold a calf, identified with back tag (b)(4) for slaughter as food. On or about August 26, 2009, this animal was also slaughtered at (b)(4). United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from these animals identified the presence of gentamicin sulfate in the kidney tissues. FDA has not established a tolerance for residues of gentamicin sulfate in the edible tissues of cattle. The presence of this drug in edible tissue from these animals causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. 342(a)(2)(C)(ii).

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. For example, you failed to maintain treatment records for the animals identified with back tags (b)(4) and (b)(4) Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. 342(a)(4).

We also found that you adulterated the new animal drug gentamicin sulfate. Specifically, our investigation revealed that you did not use gentamicin sulfate as directed by the veterinarian's prescription labeling nor as directed by its approved labeling. Use of this drug in this manner is an extralabel use. See Title 21, Code of Federal Regulations, Section 530.3(a) (21 C.F.R. 530.3(a)).

The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with sections 512(a)(4) and (5) of the Act, 21 U.S.C. 360b(a)(4) and (5), and 21 C.F.R. Part 530, including 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.

Our investigation found that you administered gentamicin sulfate to two calves, back tags (b)(4) and (b)(4) without following the dose and withdrawal period as stated in the veterinarian's prescription labeling nor as directed by its approved labeling. Your extralabel use of gentamicin sulfate resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11 (c). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused 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).

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http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm201740.htm


Double V Dairy

Department of Health and Human Services Public Health Service Food and Drug Administration Seattle District Pacific Region 22201 23rd Drive SE Bothell, WA 98021-4421 Telephone: 425-486-8788 FAX: 425-483-4996

October 28, 2009

CERTIFIED MAIL RETURN RECEIPT REQUESTED

In reply refer to Warning Letter SEA 10-05

Ray Vander Vegt, President Double V, LLC 1587 East 3100 South Wendell, Idaho, 83355

WARNING LETTER

Dear Mr. Vander Vegt:

On June 30 and July 2, 2009, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 1587 East 3100 South, Wendell, Idaho. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.

We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. 342(a)(2)(C)(ii) a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the Act, 21 U.S.C. 360b. Further, under section 402(a)(4) of the Act, 21 U.S.C. 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.

Specifically, our investigation revealed that on or about February 17, 2009, you sold 12 cows for slaughter to (b)(4) one of which was identified by (b)(4) with back tag (b)(4) On or about February 18, 2009 (b)(4) slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 3.55 parts per million (ppm) of penicillin residue in the liver, 10.62 ppm in the muscle, and 2.29 ppm in the kidney tissue. FDA has established a tolerance for residues of penicillin in the uncooked edible tissues of cattle at 0.05 ppm as codified in Title 21, Code of Federal Regulations, Section 556.510(a) (21 C.F.R. 556.510(a)). The presence of this drug in edible tissue from this animal in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. 342(a)(2)(C)(ii).

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. For example, you failed to maintain complete treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. 342(a)(4).

We also found that you adulterated the new animal drug Penicillin G Procaine Injectable Solution. Specifically, our investigation revealed that you did not use this drug as directed by its approved labeling. Use of this drug in this manner is an extralabel use. 21 C.F.R. 530.3(a).

The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with sections 512(a)(4) and (5) of the Act, 21 U.S.C. 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/c1ienUpatient relationship.

Our investigation found that in February 2009 you administered Penicillin G Procaine to the cow identified by back tag (b)(4) without following the indications or dosing instructions as stated in the drug's approved labeling. Your extralabel use of Penicillin G Procaine was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11 (a). Furthermore, your extralabel. use of Penicillin G Procaine in the cow identified by back tag (b)(4) resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11 (d). Because your extralabel uses of this drug were not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused 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).

snip...

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm189222.htm


Schlegel Dairy Farms Inc 9/11/09

Department of Health and Human Services Public Health Service Food and Drug Administration Cincinnati District Office Central Region 6751 Steger Drive Cincinnati, OH 45237-3097 Telephone: (513) 679-2700 FAX: (513) 679-2761

September 11, 2009

WARNING LETTER CIN-09-68103-17

VIA FEDERAL EXPRESS

Kurt A. Schlegel, Owner Schlegel Dairy Farms, Inc. 10720 Township Road 526 Shreve, Ohio 44676-9415

Dear Mr. Schlegel:

On May 7, 2009, and June 3, 2009, the U.S Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 10720 Township Road 526, Shreve, Ohio. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the Act and its associated regulations on the internet through links on FDA's web page at www.fda.gov.

We found that you offered for sale an animal for slaughter that was adulterated. Under section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the Act, 21 U.S.C. 360b.

Specifically, our investigation revealed that on or about October 15, 2008, you sold a Holstein bull veal calf for slaughter as food through (b)(4), where the Holstein bull veal calf was identified with back tag # (b)(4). On or about October 16, 2008, (b)(4) slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected on October 16,2008 from this bull veal calf with back tag (b)(4) identified the presence of 0.66 parts per million (ppm) sulfamethoxazole in the liver and 0.70 ppm sulfamethoxazole in the muscle of this animal. The FDA has not established a tolerance for residue associated with use of sulfamethoxazole in the edible tissue of veal calves as codified in Title 21, Code of Federal Regulations (C.F.R.), Part 556 (21 C.F.R. Part 556). The presence of this drug in the edible tissue of this bull veal calf in these amounts causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. 342(a)(2)(C)(ii).

We also found that you violated section 501(a)(5) of the Act, 21 U.S.C. 351(a)(5), when your employees administered Sulfamethoxazole and Trimethoprim Tablets, 800 milligrams (mg)/160 mg, Double Strength (NDC 61971-120-05) to the bull veal calf. Specifically, our investigation revealed that sulfamethoxazole and trimethoprim tablets were used in an extralabel manner by a layperson on your farm outside the orders, instructions, or supervision of a licensed veterinarian in violation of 21 C.F.R. 530.1 I (a), and the use of these tablets resulted in sulfamethoxazole residue which may present a risk to public health, in violation of 21 C.F.R. 530.11(c).

The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with sections 512 (a)(4) and (5) of the Act, 21 U.S.C. 360b(a)(4) and (5), and 21 C.F.R. Part 530, including 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.

Because the use of the sulfamethoxazole and trimethoprim tablets did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the Act, 21 U.S.C. 360b(a), and thus adulterated within the meaning of section 501 (a)(5) of the Act, 21 U.S.C. 351(a)(5).

snip...

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm183614.htm


Adon Farms 8/5/09

Department of Health and Human Services Public Health Service Food and Drug Administration New York District 158-15 Liberty Avenue Jamaica, NY 11433

August 5 2009

WARNING LETTER NYK 2009-15

Via Federal Express Andrew J. Gilbert Adon Farms 403 State Highway 72 Potsdam, New York 13676

Dear Mr. Gilbert:

On April 2 and 9, 2009, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm located at 403 State Highway 72, Potsdam, New York 13676. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the Act and its associated regulations on the Internet through links on FDA's web page at www.fda.gov.

We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the Act, 21 U.S.C. 360b. Further, under section 402(a)(4) of the Act, 21 U.S.C. 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.

Specifically, our investigation revealed that on or about October 15, 2008, you sold a dairy cow, identified with farm tag#(b)(4) for slaughter. On or about October 16, 2008, (b)(4) slaughtered this animal. 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 0.82 parts per million (ppm) of penicillin residue in the kidney tissue. FDA has established a tolerance for residues of penicillin in the uncooked edible tissues of cattle at 0.05 ppm as codified in Title 21, Code of Federal Regulations, Section 556.510(a) [21 C.F.R. 556.510(a)]. 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, 21 U.S.C. 342(a)(2)(C)(ii).

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. For example, you failed to maintain accurate treatment records and 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. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. 342(a)(4).

We also found that you adulterated the new animal drugs (b)(4) (Penicillin G Procaine Injectable Suspension), (b)(4) (ceftiofur hydrochloride), and (b)(4) (hetacillin potassium). Specifically, our investigation revealed that you did not use (b)(4) and (b)(4) as directed by their approved labeling. Use of these drugs in this manner is an extralabel use. See 21 C.F.R. 530.3(a).

The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with sections 512(a)(4) and (5) of the Act, 21 U.S.C. 360b(a)(4) and (5), and 21 C.F.R. Part 530, including 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.

Our investigation found that you administered the drugs (b)(4) and (b)(4) without following the dosage levels as stated in the approved labeling. Your extralabel use of these drugs was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Furthermore, your extralabel use of (b)(4) resulted in an illegal residue, in violation of 21 C.F.R. 530.11(d). In addition, you administered the drug (b)(4) without following the withdrawl period for slaughter set forth in the approved labeling. Specifically, you administered the drug (b)(4) on October 9, 2008, and then sold the dairy cow identified with farm tag # (b)(4) for slaughter on October 15, 2008. The approved labeling of (b)(4) states treated animals must not be slaughtered for food until ten days after the latest treatment. Because your extralabel use of these drugs was not in compliance with 21 C.F.R. Part 530, these drugs were unsafe under section 512(a) of the Act, 21 U.S.C. 360b(a), and your use caused them to be adulterated within the meaning of section 501(a)(5) of the Act, 21 U.S.C. 351(a)(5).

snip...

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm189754.htm


G & H Dairy #1, LLC

Department of Health and Human Services Public Health Service Food and Drug Administration Seattle District Pacific Region 22201 23rd Drive SE Bothell, WA 98021-4421 Telephone: 425-486-8788 FAX: 425-483-4996

July 31, 2009

CERTIFIED MAIL RETURN RECEIPT REQUESTED

In reply refer to Warning Letter SEA 09-24

Gilbert Hurtado, Partner G & H Dairy #1, LLC 1330 Addison Avenue W Twin Falls, Idaho 83301

WARNING LETTER

Dear Mr. Hurtado:

On April 24 and 30, 2009, the U.S. Food and Drug Administration (FDA) conducted an inspection of your dairy operation located at 3209 S 1800 E, Wendell, Idaho. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.

We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. § 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.

Specifically, our inspection revealed that on or about December 1, 2008, you sold a dairy cow, identified with back tag (b)(4) for slaughter as food. On or about December 1, 2008, (b)(4) slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of flunixin at 2.5735 parts per million (ppm) in the liver. FDA has established a tolerance of 125 parts per billion (0.125 ppm) for residues of flunixin in the liver tissues of cattle, as codified in Title 21, Code of Federal Regulations, Section 556.286 (21 C.F.R. 556.286). The presence of flunixin in the liver tissues from this animal in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. § 342(a)(2)(C)(ii).

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. For example, you failed to maintain complete treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4).

We also found that you adulterated the new animal drug flunixin. Specifically, our investigation revealed that you did not use flunixin as directed by its approved labeling. Use of this drug in this manner is an extralabel use, 21 C.F.R. 530.3(a).

The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with sections 512(a)(4) and (5) of the Act, 21 U.S.C. § 360b(a)(4) and (5), and 21 C.F.R. Part 530, including 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.

Our investigation found that you routinely administer flunixin to your animals without following the route of administration or withhold time as stated in the approved labeling. Your extralabel use of flunixin is not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11 (a). Because your use of this drug is not in conformance with its approved labeling and does not comply with 21 C.F.R. Part 530, you cause 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).

snip...

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm176800.htm


Lucky Acres 7/27/09

Department of Health and Human Services Public Health Service Food and Drug Administration PHILADELPHIA DISTRICT 900 U.S. Customhouse 2nd and Chestnut Streets Philadelphia, PA 19106 Telephone: 215-597-4390

WARNING LETTER 09-PHI-07

July 27, 2009

Amos S. King, Owner Lucky Acres 3167 Kissel Hill Road Lititz, Pennsylvania 17543-9232

Dear Mr. King:

On December 12 and 18, 2008, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 3167 Kissel Hill Road, Lititz, Pennsylvania. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during Our investigation of your operation: You can find the Act and its associated regulations on the Internet through links on FDA's web page at www.fda.gov.

We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the Act 21 U.S.C. § 342 (a)(2)(C)(ii) a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the Act, 21 U.S.C. 21 U.S.C. § 360b. Further, Under section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.

Specifically, our investigation revealed that on or about July 7, 2008, you sold a dairy cow, identified with back tag (b)(4), and ear tag (b)(4) for slaughter as food. On or about July 8, 2008, (b)(4) located in (b)(4) slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of sulfadimethoxine in the liver at 0.95 parts per million (ppm) and in the muscle at 1.03 ppm and penicillin in the liver at 0.13 ppm FDA has established a tolerance for residues of sulfadimethoxine in the uncooked edible tissues of cattle at 0.1 ppm as codified in Title 21, Code of Federal Regulations, Section 556.640 (21 C.F.R. 556.640,and a tolerance for residues of penicillin in the uncooked edible tissues of cattle at 0.05 ppm as codified in 21 C.F.R. 556.510 The presence of these drugs in edible tissue from this animal in these amounts causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. § 342(a)(2)(C)(ii).

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 treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4).

We also found that you adulterated the new animal drugs sulfadimethoxine and penicillin. Specifically, our investigation revealed that you did not use sulfadimethoxine and penicillin as directed by their approved labeling. Use of these drugs in this manner is an extralabel use. 21 C.F.R. 530.3(a).

The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with sections 512(a)(4) and (5) of the Act, 21 U.S.C. §§ 360b(a)(4) and (5), and 21 C.F.R. Part 530, including 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.

Our investigation found that you administered sulfadimethoxine to a dairy cow identified with back tag (b)(4) and eartag (b)(4), without following the indications for use contained in the approved labeling. Sulfadimethoxine is prohibited for extralabel use in lactating dairy cows by 21 C.F.R. 530.41(a)(9). Further, your extralabel use of this drug resulted in illegal drug residues in this animal, in violation of 21 C.F.R. 530.11(d). In addition, our investigation found that you administered penicillin to a dairy cow, identified with back tag (b)(4) and ear tag (b)(4) without following the indications for use or dose contained in the approved labeling. Your extralabel use of penicillin was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Because your extralabel uses of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drugs 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).

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm186911.htm


Van Raay Dairy Farm 7/14/09

Department of Health and Human Services Public Health Service Food and Drug Administration Cincinnati District Office Central Region 6751 Steger Drive Cincinnati, OH 45237-3097 Telephone: (513) 679-2700 FAX: (513) 679-2771

July 14, 2009

WARNING LETTER CIN-09-67403-12

VIA FEDERAL EXPRESS

Sybrand T.C. Van Raaj, Owner and Manager Van Raay Dairy Farm 12471 Thomas Road South Charleston, OH 45368

Dear Mr. Van Raaj:

On April 23, 24, and 27, May 7 and 19, and June 18,2009, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 12471 Thomas Road, South Charleston, Ohio 45368. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the Act and its associated regulations on the Internet through links on FDA's web page at www.fda.gov.

We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. § 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.

Specifically, our investigation revealed that on or about June 30, 2008, you sold ten calves, one of which was a bull calf that was given back tag (b)(4) by the hauler and sold for slaughter as food. On or about July 1, 2008, (b)(4) of (b)(4) slaughtered this animal. The United States Department of Agriculture, Food Safety and Inspection Service (USDAJFSIS) analysis of tissue samples collected from this animal identified the presence of 10.95 ppm neomycin in the kidney. FDA has established a tolerance of 7.2 ppm of neomycin in the kidney of cattle as codified in Title 21, Code of Federal Regulations, Section 556.430 (21 C.F.R. 556.430). The presence of this drug in the edible tissue from this animal in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. § 342(a)(2)(C)(ii).

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. For example, you failed to maintain complete treatment records and failed to identify treated animals. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4).

snip...

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm183498.htm


please see ;


http://staphmrsa.blogspot.com/



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

Thursday, February 11, 2010

Denmark's Case for Antibiotic-Free Animals

NEW YORK, Feb. 10, 2010

Denmark's Case for Antibiotic-Free Animals

Katie Couric Reports on Denmark's Ban on Antibiotics in Livestock

CBS) They call it the "Danish Experiment" - a source of pride for the country's 17,000 farmers. CBS Evening News Anchor Katie Couric reports how unlike industrial farms in the U.S., which use antibiotics to promote growth and prevent disease, farmers in Denmark use antibiotics sparingly, only when animals are sick.

The experiment to stop widespread use of antibiotics was launched 12 years ago, when European studies showed a link between animals who were consuming antibiotic feed everyday and people developing antibiotic resistant infections from handling or eating that meat.

"We don't want to use more medicine than needed, and a lot of the medicine that is given is not needed," said Soren Helmer. Helmer is a second-generation pig farmer whose sows produce more than 30,000 pigs a year. When the ban started, he and his father thought the industry would suffer.

"We thought we could not produce pigs as efficient as we did before," Helmer said. "But that was proven wrong."

Since the ban, the Danish pork industry has grown by 43 percent - making it one of the top exporters of pork in the world. All of Europe followed suit in 2006. But the American Pork Industry doesn't want to.

"What we've seen in Denmark and other countries is that they actually have had some increases in cost of what it takes to produce a pig," said Liz Wagstrom, a veterinarian with the National Pork Board.

"So it's not that unqualified a success. If we did the same thing in the United States, we would likely see small producers pushed out of business, we'd have more sick and dying pigs, and none of that would result in a benefit to the U.S. consumer."

Without growth-promoting antibiotics, it only costs $5 more for every 100 pounds of pork brought to market in this country.

Animal Antibiotics a Threat?

That's a small price for public health, says Dr. Ellen Silbergeld, who has been studying the antibiotic resistance link between livestock and people for the past decade.

"I think the Danish and European experience indicate that there will be real and measurable public health benefits," she said. "There'll be improvements in food safety and actually in the prevalence of drug resistant infections in people."

Pew Campaign on Human Health and Industrial Farming

According to one study, when different countries introduced certain antibiotics on farms, a surge occurred in people contracting antibiotic resistant intestinal infections one to two years later. One infection, Campylobacter, increased 20 percent in Denmark and 70 percent in Spain.

After the ban, a Danish study confirmed that removing antibiotics from farms drastically reduced antibiotic-resistant bacteria in animals and food.

Danish scientists believe if the U.S. doesn't stop pumping its farm animals with antibiotics, drug-resistant diseases in people will only spread.

"It's not going to be a time bomb that goes off like this," said Dr. Frank Aarestrup, of the Danish Food Institute at the University of Denmark. "It's something that's slowly getting more and more complicated, more difficult for us to actually treat infections.

Rep. Slaughter's "Preservation of Antibiotics for Medical Treatment Act"

Some American food producers agree.

"It's just gone too far," said Stephen McDonnell, CEO Applegate Farms.

"What most bothers you about the way industrial farmers in this country currently operate," Couric asked.

"We use too many antibiotics, we use too many growth promotants," McDonnell replied. "The singular focus is to create cheap meat. That's not always the best thing for the health of the Americans who buy it."

"We think with some subtle changes - giving them more space, feeding them a good diet, and not stressing them out by growing them too quickly - you don't even need to use antibiotics," McDonnell added.

McDonnell helps farmers like Duane Koch kick the habit.

"How long have you been raising turkeys, Duane, without using antibiotics," Couric asked.

"We started running without antibiotics roughly 14 years ago," Koch replied.

"Does it make you feel better doing it this way," Couric asked.

"Yeah," Koch said. "Because really, from using the antibiotics so long, a lot of them didn't work well any way anymore."

Today his 18 poultry farms scattered throughout Pennsylvania are more profitable than when he used antibiotics.

Koch says it costs very little to convert a farm to antibiotic-free. And it doesn't cost consumers much more either. People buying antibiotic free turkey thigh meat will spend around $1.40 versus $1.20 for conventionally raised birds.

Koch says higher-quality feed and improving living conditions, his birds are naturally healthier.

Couric asked, "What's the importance of giving them more space?"

"That's just our natural growth promotants," he said. "By giving them more space, we can get weights that are really close to what they're getting, you know, with the growth promotants."

Because farmers are raising livestock successfully without growth-promoting antibiotics - from Lebanon, Pennsylvania to outside Copenhagen - public health officials in this country say this is an idea whose time has come.

"We have identified here that we're talking about a public health issue, that the overuse of antibiotics on farms does pose a risk to human health," said Joshua Sharfstein of the FDA.

The FDA has for the first time come out against using certain antibiotics to promote growth in livestock.

And pending legislation in Congress would ban some types of antibiotics used to treat humans from being administered to healthy farm animals.


http://www.cbsnews.com/stories/2010/02/10/eveningnews/main6195054.shtml



Hello Ms. Couric Ma'am !

Thank you very much on that show of yours about antibiotics in meat, the over-use-of, and resistance there from, to humans and animals. Nice Job! The public is just oblivious to what is going on with the meat they eat. I thought the Danish study was remarkable, and proves what can be done, if an industry wants to do something. sadly, here in the USA, all the industry cares about is their bottom dollar. I have been most concerned about hormones, antibiotics, TSE aka mad cow disease, and other pathogens in meat for some time. I lost my mother to the Heidenhain Variant of Creutzfeldt Jakob Disease, considering North America is home to c-BSE, h-BSE, and the l-BSE in cattle, who is it to say that it should look exactly like the UK c-BSE ??? THEN, my last neck surgery, I believe my neurosurgeon did use a special bone grinder and a few extra precaustion, due to my Mother having died from hvCJD, and they damn near kill me with MRSA. Looking into to that, I was amazed at the amount of antibiotics and hormones that go into cattle due to the fact they are to sick to slaughter. 8 weeks vancomycin straight to the heart via long pic line made a believer in me. now I know some how I was infected probably via the operating arena, there were 7 other's the same week from the same surgcial unit, I was told later (this was in 2002), but we have become immune to these medicines due to over use, not only in humans but animals for human consumption as well. at any given tuesday you can find something like this ;


October 9,2009

WARNING LETTER

CERTIFIED MAIL RETURN RECEIPT REQUESTED

Keith L. Schaeffer Owner Evergreen Acres Dairy, LLC 26162 240th Street Paynesville, Minnesota 56362

Dear Mr. Schaeffer:

Refer to MIN 10 - 01

On April 23 and May 4,2009, the Minnesota Department of Agriculture conducted an investigation of your dairy operation located at 26162 240th Street, Paynesville, Minnesota. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that were found during the investigation of your operation. You can find the Act and its associated regulations on the Internet through links on FDA's web page at www.fda.gov.

The investigation found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. § 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.

Specifically, the investigation revealed that on or about September 16, 2008, you sold a dairy cow identified with your farm ear tag #(b)(4)for slaughter as food. On or about September 17, 2008, (b)(4) slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of neomycin at 31.05 parts per million (ppm) in kidney tissue. FDA has established a tolerance of 7.2 ppm neomycin residue in kidney tissue as codified in Title 21, Code of Federal Regulations, Section 556.430(b)(1), 21 C.F.R. 556.430(b)(1). The presence of this drug in kidney tissue from this animal in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. § 342(a)(2)(C)(ii).

The 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. For example, you failed to maintain complete treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4).

The investigation also found that you adulterated the new animal drugs neomycin sulfate, sulfadimethoxine oral solution, oxytetracycline injection, oxytetracycline hydrochloride injection, ceftiofur hydrochloride, ceftiofur crystalline free acid, ceftiofur sodium, penicillin G procaine aqueous suspension, florfenicol, tetracycline hydrochloride soluble powder, and tylosin. Specifically, the investigation revealed that you did not use these drugs as directed by their approved labeling. Use of these drugs contrary to their approved labeling is an extralabel use. See 21 C.F.R. 530.3(a).

The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with sections 512(a)(4) and (5) of the Act, 21 U.S.C. §§ 360b(a)(4) and (5), and 21 C.F.R. 530, including 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.

The investigation found that you administered neomycin sulfate to lactating dairy cows contrary to the approved indication of use. Neomycin sulfate is not approved for the treatment and control of Salmonella infections. Your extralabel use of neomycin sulfate was not in compliance with 21 C.F.R. 530, and your extralabel use of neomycin sulfate resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d).

The investigation also found that you administered the following new animal drugs contrary to the conditions of use set forth in their approved labeling, and you did so without the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a):

1. Neomycin sulfate (b)(4) - You administered neomycin sulfate to a lactating dairy cow without following the approved indication of use. Neomycin Sulfate (Neomycin Liquid) is not approved for the treatment and control of Salmonella infections.

2. Sulfadhnethoxine oral solution (b)(4) - You administered sulfadimethoxine oral solution to lactating dairy cows without following the approved route of administration, indications for use, and animal class. Sulfadimethoxine oral solution is not approved for intravenous injection, not approved to treat peritonitis, and not approved for use in lactating dairy cows. Furthermore, sulfonamide drugs, which include sulfadimethoxine, are prohibited for extralabel use in lactating dairy cows by 21 C.F.R. 530.41(a)(9).

3. Oxytetracycline injection (b)(4) - You administered oxytetracycline injection to lactating dairy cows without following the approved dose per injection site. Oxytetracycline injection is not approved for use at more than 10 mL per injection site.

4. Oxytetracycline hydrochloride injection (b)(4) - You administered oxytetracycline hydrochloride injection to lactating dairy cows without following the approved animal class and indications for use. Oxytetracycline hydrochloride injection is not approved for use in lactating dairy cattle, or to treat peritonitis.

5. Ceftiofur hydrochloride (b)(4) - You administered ceftiofur hydrochloride to lactating dairy cows without following the approved indications for use. Ceftiofur hydrochloride is not indicated for treating watery mastitis in cattle, or for post-surgical use.

6. Ceftiofur crystalline free acid (b)(4) - You administered ceftiofur crystalline free acid to lactating dairy cows without following the approved indications of use. Ceftiofur crystalline free acid is not indicated for treating watery mastitis, foot rot, or metritis in cattle, nor is it approved for postsurgical use.

7. Ceftiofur sodium (b)(4) - You administered ceftiofur sodium to lactating dairy cows without following the approved indications for use. Ceftiofur sodium is not indicated for treating watery mastitis or metritis in cattle, nor is it approved for post-surgical use.

8. Penicillin G procaine (b)(4) - You administered penicillin G procaine aqueous suspension to lactating dairy cows without following the approved indications for use, dosage amount, or dosage amount per injection site. Penicillin G procaine aqueous suspension is not indicated for treating mastitis in cattle, not approved at a dose more than 1 mLI100 pounds of body weight, and not approved for use at the rate of more than 10 mL per injection site.

9. Florfenicol (b)(4) - You administered florfenicol to lactating dairy cows without following the approved animal class. Florfenicol is not approved for use in female dairy cattle 20 months of age or older.

10.Tetracycline hydrochloride soluble powder (b)(4) - You administered tetracycline hydrochloride soluble powder to lactating dairy cows without following the approved animal class and indications for use. Tetracycline hydrochloride soluble powder is not approved for treating dairy cows or for treatment of uterine infections.

11. Tylosin (b)(4) - You administered tylosin to dairy calves without following the approved route of administration and indications for use.Tylosin is not approved for oral administration, nor is the drug approved for preventing scours (bacterial enteritis) in dairy calves. Furthermore, the extralabel use of approved new animal or human drugs in or on an animal feed (milk) is prohibited by 21 C.F.R. 530.11(b).

Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. 530, you caused the drugs to be unsafe under section 512(a) of the Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 50 1(a)(5) of the Act, 21 U.S.C. § 351(a)(5).

In addition, you adulterated animal feed (milk) within the meaning of section 501 (a)(6) of the Act, 21 U.S.C. § 351 (a)(6). You administered tylosin to dairy calves to prevent Escherichia coli (E. colI) scours by mixing the drug in milk. This caused the animal feed (milk) to which the drug was added to be unsafe within the meaning of section 512(a)(2) of the Act, 21 U.S.C. § 360b(a)(2), and adulterated under section 501(a)(6) of the Act, 21 U.S.C. § 351(a)(6).

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 violations described in this letter and to establish procedures to ensure that these 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 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 to prevent their recurrence. If corrective action cannot be completed within 15 working days of receiving this letter, 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 written response should be sent to Dr. Brian D. Garthwaite, Compliance Officer, U.S. Food and Drug Administration, at the address located on the letterhead. If you have any questions about this letter, please contact Dr. Garthwaite at (612) 758-7132.

Sincerely,

/s/

W. Charles Becoat Director Minneapolis District

BDG/ccl

(b)(4)

Doug Leuders Minnesota Department of Agriculture 625 North Robert Street St. Paul, Minnesota 55155

District Manager, USDA-FSIS Butler Square West, Suite 989-C 100 North Sixth Street Minneapolis, Minnesota 55403


http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm186791.htm



“October 2009

It should be noted that humans can become more susceptible to infection with antimicrobial-resistant zoonotic bacteria to which they are exposed. This can happen, when there has been prior use of antimicrobials, resulting in decrease in colonization resistance (dysregulation of intestinal microbiota) and an increased vulnerability to gastrointestinal illness with antimicrobial-resistant food-borne pathogens. This applies to all infections with all micro-organisms listed in this document.

snip...



http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/1372.pdf?ssbinary=true



http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm189754.htm



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.


http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm189720.htm



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.


http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm189789.htm



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.

Recently Posted Warning Letters Posted on November 17, 2009


http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm



see also my blog on MRSA here ;


http://staphmrsa.blogspot.com/




IN regards to the Industry hype about that mean old Katie Couric and CBS on the Danish Study on antibiotics and the overuse there of, or not, I wish to submit the following ;




Methicillin-Resistant Staphylococcus aureus (MRSA) Strain ST398 Is Present in Midwestern U.S. Swine and Swine Workers

Recent research has demonstrated that many swine and swine farmers in the Netherlands and Canada are colonized with MRSA. However, no studies to date have investigated carriage of MRSA among swine and swine farmers in the United States (U.S.).

We sampled the nares of 299 swine and 20 workers from two different production systems in Iowa and Illinois, comprising approximately 87,000 live animals. MRSA isolates were typed by pulsed field gel electrophoresis (PFGE) using SmaI and EagI restriction enzymes, and by multi locus sequence typing (MLST). PCR was used to determine SCCmec type and presence of the pvl gene.

In this pilot study, overall MRSA prevalence in swine was 49% (147/299) and 45% (9/20) in workers. The prevalence of MRSA carriage among production system A's swine varied by age, ranging from 36% (11/30) in adult swine to 100% (60/60) of animals aged 9 and 12 weeks. The prevalence among production system A's workers was 64% (9/14). MRSA was not isolated from production system B's swine or workers. Isolates examined were not typeable by PFGE when SmaI was used, but digestion with EagI revealed that the isolates were clonal and were not related to common human types in Iowa (USA100, USA300, and USA400). MLST documented that the isolates were ST398.

These results show that colonization of swine by MRSA was very common on one swine production system in the midwestern U.S., suggesting that agricultural animals could become an important reservoir for this bacterium. MRSA strain ST398 was the only strain documented on this farm. Further studies are examining carriage rates on additional farms.

snip...

Discussion

This study is the first to document MRSA in U.S. swine and swine workers, and to our knowledge, the first to report the presence of ST398 (also reported as non-typeable MRSA, NT-MRSA) [15] in the U.S. Like previous studies in Canada, Denmark, and the Netherlands [11], [12], [24], ST398 was found in both animals and humans, suggesting transmission between the two. The prevalence of MRSA colonization among swine and swine workers was high at one farm system that we examined in the Midwestern U.S., suggesting that agricultural animals could become an important reservoir for this bacterium. Strain ST398 was the only MRSA identified among the swine and swine workers. This strain has been the predominant strain among swine in the Netherlands and Canada. However, Khanna et al. in Canada recently found both ST398 and ST5/USA100 colonizing the nares of swine and swine workers [12]. This difference may indicate that the epidemiology of MRSA on Canadian swine farms is different than on the affected farm system in Iowa and Illinois. On the other hand, the difference may have resulted from differing sampling methodologies. Khanna et al. sampled a small number of humans and swine on 20 farms whereas we took a larger number of samples from a smaller number of farms in two corporate systems. Furthermore, because we did not type all isolates in this pilot study, additional strain types may be present that we did not detect.

snip...

In summary, we report the first isolation of MRSA from swine and swine workers in the U.S. Although the extent of this problem in the U.S. is currently unknown, our findings may have important implications for the epidemiology of MRSA disease. For example, Van Loo et al. identified MRSA in meat products in the Netherlands [32], suggesting that persons who handle raw pork products might be at risk for acquiring MRSA. Future studies should assess the risk of MRSA disease among swine workers and their contacts, survey retail meat products for MRSA contamination, study larger populations of swine and humans to define the epidemiology of MRSA within swine operations, and assess MRSA carriage rates in other livestock.

full text ;




http://www.plosone.org/article/fetchObjectAttachment.action?uri=info%3Adoi%2F10.1371%2Fjournal.pone.0004258&representation=PDF




From Emerging Infectious Diseases

Staphylococcus aureus ST398, New York City and Dominican Republic

Meera Bhat; Caroline Dumortier; Barbara S. Taylor; Maureen Miller; Glenny Vasquez; Jose Yunen; Karen Brudney; Jacqueline Sánchez E.; Carlos Rodriguez-Taveras; Rita Rojas; Patricia Leon; Franklin D. Lowy

Authors and Disclosures

Posted: 05/11/2009; Emerging Infectious Diseases © 2008 Centers for Disease Control and Prevention (CDC)

Abstract Closely related Staphylococcus aureus strains of ST398, an animal-associated strain, were identified in samples collected from humans in northern Manhattan, New York, NY, USA, and in the Dominican Republic. A large population in northern Manhattan has close ties to the Dominican Republic, suggesting international transmission.




We identified a clone of S. aureus previously associated with outbreaks of infections in animals and in humans who work with animals in 2 unique collections of S. aureus isolates. The first was from a population-based study of S. aureus colonization among residents of northern Manhattan in New York, NY, USA;


Consequently, the clone is identified by multilocus sequence typing as sequence type 398 (ST398).



Page 2 of 7

Dominican Republic within 6 months of their interview, none of the colonized participants reported recent travel to the Dominican Republic. No contact among the different households was reported.




http://www.cdc.gov/eid/content/15/2/pdfs/08-0609.pdf







First human isolates of methicillin-resistant Staphylococcus aureus sequence type 398 in Spain


C. Potel & M. Álvarez-Fernández & L. Constenla & P. Álvarez & S. Perez


Received: 31 July 2009 / Accepted: 13 December 2009 # Springer-Verlag 2010


To the Editor,


An emerging sequence type (ST) 398 methicillin-resistant Staphylococcus aureus (MRSA) clone producing infections in humans has been detected across Europe [1]. Recent studies indicate that it is widely distributed in farm animals, particularly in pigs, suggesting transmission between animals and humans [2].


The frequency of MRSA ST398 in the Spanish population is unknown. In this study, we present the first three human cases of MRSA ST398 infections admitted to two hospitals in the north-west of Spain.


Forty-four MRSA strains were isolated in 2006 in both hospitals. They were studied by the analysis of restriction fragment length polymorphism (RFLP) of the coagulase gene patterns and pulsed-field gel electrophoresis (PFGE) [3, 4]. Three non-Sma I typeable MRSA strains were identified; the three strains were EagI PFGE typeable. Next, they were analyzed by multilocus sequence typing (MLST) and spa typing [5, 6]. The staphylococcal chromosome cassette (SCC) mec, the accessory gene regulator (agr) types, and the Panton–Valentine leukocidin (PVL)-encoding genes were polymerase chain reaction (PCR)-identified [7–9].


The three strains were resistant to tetracycline. Besides, one isolate was resistant to levofloxacin, tobramycin, and erythromycin, and another isolate was resistant to levofloxacin and clindamycin, and susceptible to erythromycin; this rare phenotype has already been described [2]. The three MRSA isolates were identical by RFLP. By EagI PFGE, they were closely related following Tenover’s criteria (Fig. 1) [10]. All isolates were ST398, SCCmec-V, agr-1, and PVL genes-negative. They belonged to three spa types; t108, t011, and t1255.


The age of the three patients was 59, 82, and 83 years, respectively. Two patients owned pigs and the other a calf. Two patients were diabetic and were hospitalized because they developed skin and soft-tissue infections by MRSA ST398. The third patient had bronchitis and the strain was isolated from a respiratory secretion submitted to the laboratory from an outpatient clinic. The three patients had had multiple hospital admissions in the last 12 months.


As it has been described previously, the ST398 isolates were resistant to tetracycline [2]. Only another strain from the 44 MRSA strains studied was also resistant to tetracycline. This one belonged to the ST239 clone that was epidemic in north-west Spain until 2002, and since then, it has scarcely been isolated [3]. The ST239 clone is easily identified because of the homogeneity in the resistance profile (it is also resistant to levofloxacin, gentamicin, tobramycin, erythromycin, clindamycin, trimethoprim-sulfamethoxazole, and chloramphenicol) [3]. Therefore, it can be stated that the resistance to tetracycline could be a local marker for a presumptive identification of the ST398 clone.



http://www.springerlink.com/content/p8866u775tvm51w5/fulltext.pdf?page=1



Volume 16, Number 1–January 2010


Letter Skin Lesion Caused by ST398 and ST1 MRSA, Spain1


Carmen Aspiroz, Carmen Lozano, Ana Vindel, Juan J. Lasarte, Myriam Zarazaga, and Carmen Torres Author affiliations: Hospital Royo Villanova, Zaragoza, Spain (C. Aspiroz); Universidad de La Rioja, Logroño, Spain (C. Lozano, M. Zarazaga, C. Torres); Centro Nacional Microbiología, Madrid, Spain (A. Vindel); and Centro Salud San Mateo de Gállego, Zaragoza (J.J. Lasarte) Suggested citation for this article


To the Editor:


Human infections caused by methicillin-resistant Staphylococcus aureus (MRSA) sequence type 398 (ST398) have been emerging in recent years in Europe (1,2). Pigs represent a common reservoir of MRSA ST398, and working with these animals may constitute a risk factor for MRSA carriage and possible infection (2–4). We report a case of human infection caused by MRSA ST398 in Spain.


SEE FULL TEXT ;



http://www.cdc.gov/eid/content/16/1/157.htm



Eurosurveillance, Volume 13, Issue 9, 28 February 2008

Rapid communications


First outbreak of methicillin-resistant Staphylococcus aureus ST398 in a Dutch hospital, June 2007


M WH Wulf (mireille.wulf@gmail.com)1, A Markestein2, F T van der Linden3, A Voss4, C Klaassen4, C M Verduin1,2


1. Laboratory for Pathology and Medical Microbiology, Veldhoven, the Netherlands 2. Department of Hospital Infection Control, St Anna Hospital, Geldrop, the Netherlands 3. Department of Surgery, St Anna Hospital, Geldrop, the Netherlands 4. Department of Medical Microbiology and Infectious Diseases, Canisius-Wilhelmina Hospital, Nijmegen, the Netherlands


We describe the first outbreak of non-typable methicillin-resistant Staphylococcus aureus on a surgical ward in the Netherlands in June 2007. Nine cases of infection and/or colonisation were found among patients and healthcare workers.


Background


In the Netherlands, the proportion of methicillin-resistant S. aureus (MRSA) among clinical isolates of S. aureus is still low [1], but community-acquired MRSA occurs more frequently [2]. This increase is mainly caused by so called ‘non-typable’ MRSA (NTMRSA, i.e. not typable by pulsed-field gel electrophoresis (PFGE) with Sma1 restriction digest [3]) belonging to multilocus sequence typing (MLST) type ST398 [4].


These strains are widely disseminated among pigs, veal calves and people in contact with pigs [5-8]. An association between the use of antibiotics in pig farming and the dissemination of these strains has been suggested [6,8], since the majority of ST398 MRSA are tetracycline-resistant and oxytetracyclins are the most frequently used antibiotics in pig farming.


Transmission within families, as well as single cases of colonised healthcare workers, have been described [5]. One report indicates possible healthcare-acquired infections with a Panton-Valentine leukocidin (PVL)- positive ST398 strain in China [9], but no nosocomial transmission to multiple patients or healthcare workers has occurred in the Netherlands to date.


Outbreak description


In June 2007, MRSA was cultured from a diabetic foot ulcer of a patient on a surgical ward. Subsequent screening of contacts among patients and healthcare workers revealed four additional patients with MRSA infection and/or colonisation and five healthcare workers who carried MRSA.


Two of the five affected patients (one with prostate carcinoma and one with a diabetic foot) were successfully decolonised with mupirocin nasal ointment, chlorhexidine wash, and treatment with trimetoprim/rifampicin.


A further colonised patient with a gastro-intestinal malignancy and two patients with infected diabetic foot ulcers remained colonised, despite several decolonisation regimens.


Of 238 healthcare workers who were screened, five were colonised in the nose and/or throat and had no skin conditions. All five have been treated with mupirocin nasal ointment and chlorhexidine wash and successfully decolonised.


All strains were resistant to tetracycline and non-typable by PFGE. Spa-typing showed that all strains were spa-type t567. This spa-type corresponds to MLST type 398, a type previously found in pigs.


None of the patients had had contact with pigs or veal calves. One healthcare worker lived on the grounds of a pig farm but neither she nor her partner came into contact with pigs themselves. While we presume that this health care worker was the source of the infection, this could not be proven. Permission to sample the pigs on this farm was not granted.


Conclusions


The NT-MRSA strain responsible for this outbreak was spa-type t567, which corresponds to MLST type ST398, the clonal complex to which most of NT-MRSA strains belong. This outbreak shows that transmission on a larger scale than a one-on-one transmission between caretaker and patient can occur with NT-MRSA in a hospital setting.


References


http://www.eurosurveillance.org/images/dynamic/EE/V13N09/art8051.pdf


EDITORIAL


MRSA in livestock animals—an epidemic waiting to happen?


M. Wulf 1 and A. Voss 2,3 1 PAMM Laboratory for Medical Microbiology, Veldhoven , 2 Department of Medical Microbiology, Nijmegen University Centre for Infectious Diseases, Radboud University Nijmegen Medical Centre and 3 Department of Medical Microbiology and Infectious Diseases, Canisius-Wilhelmina Hospital, Nijmegen, The Netherlands Corresponding author and reprint requests: A. Voss, Department of Medical Microbiology, Nijmegen University Centre for Infectious Diseases, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands E-mail: vossandreas@gmail.com Copyright © 2008 European Society of Clinical Microbiology and Infectious Diseases


KEYWORDS Community-acquired MRSA • epidemiology • livestock • methicillin-resistant Staphylococcus aureus • pig farming • ST398


ABSTRACT


Screening of pig farmers and pigs in The Netherlands has revealed that >20% of pig farmers and 39% of slaughterhouse pigs are positive for an unusual strain of methicillin-resistant Staphylococcus aureus (MRSA) belonging to sequence type (ST) 398. It is now clear that the emergence of ST398 is not just a Dutch problem, with human infections being described in several European countries, Canada and Singapore. Furthermore, some human isolates have now acquired the genes encoding Panton–Valentine leukocidin. Livestock may become an important source of community-acquired MRSA. A concerted effort on the part of clinicians, infection control practitioners and veterinarians will be required to prevent further spread of this novel strain of MRSA.


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


DIGITAL OBJECT IDENTIFIER (DOI) 10.1111/j.1469-0691.2008.01970.x About DOI


http://www3.interscience.wiley.com/journal/119414762/abstract?CRETRY=1&SRETRY=0




Emerg Infect Dis. 2009 May; 15(5): 845–847. doi: 10.3201/eid1505.081417. PMCID: PMC2687035


Copyright notice

Community-acquired Methicillin-Resistant Staphylococcus aureus ST398 Infection, Italy

Angelo Pan, Antonio Battisti, Alessia Zoncada, Francesco Bernieri, Massimo Boldini, Alessia Franco, Maurilio Giorgi, Manuela Iurescia, Silvia Lorenzotti, Mario Martinotti, Monica Monaci, and Annalisa Pantosti Istituti Ospitalieri di Cremona, Cremona, Italy (A. Pan, A. Zoncada, F. Bernieri, S. Lorenzotti, M. Martinotti) Istituto Zooprofilattico Sperimentale delle Regioni Lazio e Toscana, Rome, Italy (A. Battisti, A. Franco, M. Iurescia) Istituto Zooprofilattico Sperimentale delle Regioni Lombardia ed Emilia-Romagna, Cremona (M. Boldini) Azienda Sanitaria Locale di Cremona, Cremona (M. Giorgi) Istituto Superiore di Sanità, Rome (M. Monaci, A. Pantosti)

Corresponding author. Address for correspondence: Angelo Pan, Divisione di Malattie Infettive, Istituti Ospitalieri di Cremona, Largo Priori 1, 26100 Cremona, Italy; email: a.pan@ospedale.cremona.it

Keywords: Antimicrobial resistance, staphylococci, Staphylococcus aureus, community acquired, MRSA, ST398, pig strain, bloodstream infection, letter

To the Editor: Community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA) has been identified in livestock animals (particularly pigs), veterinarians, and animal farm workers (1,2). CA-MRSA strains from pigs have been classified most frequently within the multilocus sequence type (ST) 398 (1) and have been rarely identified as a cause of invasive infection in humans (1,3,4). We report a case of invasive infection in a pig-farm worker in Cremona, Italy, an intensive animal farming area; the infection was caused by MRSA of swine origin, ST398.

full text ;


http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2687035/




EID Journal Home > Volume 16, Number 2–February 2010

Volume 16, Number 2–February 2010 Letter Methicillin-Resistant Staphylococcus aureus ST398, Italy Laura Soavi, Roberto Stellini, Liana Signorini, Benvenuto Antonini, Palmino Pedroni, Livio Zanetti, Bruno Milanesi, Annalisa Pantosti, Alberto Matteelli, Angelo Pan, and Giampiero Carosi Author affiliations: University of Brescia, Brescia, Italy (L. Soavi, R. Stellini, L. Signorini, A. Matteelli, G. Carosi); Presidio Ospedaliero di Manerbio, Manerbio, Italy (B. Antonini, P. Pedroni, L. Zanetti, B. Milanesi); Istituto Superiore di Sanità, Rome, Italy (A. Pantosti); and Istituti Ospitalieri di Cremona, Cremona, Italy (A. Pan)

Suggested citation for this article

To the Editor: It has recently become apparent that livestock can constitute a new methicillin-resistant Staphylococcus aureus (MRSA) reservoir and be a source of a novel and rapidly emerging type of MRSA. These livestock-associated MRSA clones are nontypeable by use of pulsed-field gel electrophoresis with SmaI and belong to sequence type (ST) 398 (1). MRSA ST398 clones account for 20% of all MRSA in the Netherlands (2), but the emergence of such clones has been described worldwide (3). Although ST398 transmission has been reported primarily between animals, persons with occupational exposure to livestock are at higher risk for MRSA carriage than the general population. Even though MRSA ST398 usually causes colonization, several cases of infections of variable clinical relevance, varying from skin and soft tissue infections (4) to endocarditis (5) and pneumonia (6), have been described over the past few years. Most instances of ST398 human carriers have been identified among persons who work at pig farms (7). Data regarding MRSA colonization of dairy farmers are less exhaustive and, to our knowledge, only 1 instance of direct transmission between cattle and humans has been proven. MRSA isolates from cows with subclinical mastitis in 2007 in Hungary were indistinguishable from MRSA isolates from the tonsil swab of a farmer who worked with these animals (. We report a case of MRSA ST398 invasive disease in a cattle farmer, as well as a case of MRSA ST398 necrotizing fasciitis


http://www.cdc.gov/eid/content/16/2/346.htm




Volume 15, Number 7–July 2009


Dispatch Methicillin-Resistant Staphylococcus aureus ST398 in Swine Farm Personnel, Belgium


Olivier Denis, Carl Suetens,1 Marie Hallin, Boudewijn Catry, Ilse Ramboer, Marc Dispas, Glenda Willems, Bart Gordts, Patrick Butaye, and Marc J. Struelens Author affiliations: Université Libre de Bruxelles Hôpital Erasme, Brussels, Belgium (O. Denis, M. Hallin, M.J. Struelens); Scientific Institute of Public Health, Brussels (C. Suetens, B. Catry, I. Ramboer); Veterinary and Agrochemical Research Centre, Brussels (M. Dispas, G. Willems, P. Butaye); and AZ Sint-Jan, Brugge, Belgium (B. Gordts)

Abstract We assessed methicillin-resistant Staphylococcus aureus (MRSA) in persons on 49 swine farms in Belgium. Surveys showed that 48 (37.8%) persons carried MRSA ST398 and 1 (0.8%) had concurrent skin infection. Risk factors for carriage were MRSA carriage by pigs, regular contact with pigs and companion animals, and use of protective clothing.

snip...

Conclusions Human carriage of MRSA was associated with swine colonization with MRSA. Prevalence rate (38%) was higher than that for hospitalized patients or nursing home residents in Belgium (www.nsih.be/surv_mrsa/download_fr.asp). MRSA isolates from farmers belonged to closely related spa types corresponding to ST398, which are unrelated to hospital- and community-acquired strains but identical to strains from humans in contact with pigs in other European countries (1,2,10).

Despite the high prevalence of nasal MRSA, active MRSA skin infection was detected infrequently (<1%),


http://www.cdc.gov/EID/content/15/7/1098.htm%22%3Ehttp://www.cdc.gov/EID/content/15/7/1098.htm




doi:10.1016/j.vetmic.2009.12.044 How to Cite or Link Using DOI Copyright © 2010 Elsevier B.V. All rights reserved. Permissions & Reprints


Methicillin-resistant Staphylococcus aureus (MRSA) ST398 associated with clinical and subclinical mastitis in Belgian cows


Wannes Vanderhaeghena, b, , , , Tineke Cerpentierc, Connie Adriaensena, Jo Viccac, Katleen Hermansb and Patrick Butayea, b


a Veterinary and Agrochemical Research Center, CODA-CERVA-VAR, Groeselenberg 99, B-1180 Ukkel, Belgium


b Ghent University, Faculty of Veterinary Medicine, Department of Pathology, Bacteriology and Poultry Diseases, Salisburylaan 133, 9820 Merelbeke, Belgium


c University College KaHo Sint-Lieven, Association Catholic University Leuven, Department of Agro- and Biotechnology, Hospitaalstraat 23, 9100 Sint-Niklaas, Belgium


Received 28 October 2009; revised 24 December 2009; accepted 28 December 2009. Available online 11 January 2010.

Abstract


Methicillin-resistant Staphylococcus aureus (MRSA) is infrequently reported in mastitis. Yet, as in many other countries, the prevalence of methicillin resistance among S. aureus from mastitis is currently unknown in Belgium.


To elucidate this, the presence of mecA was investigated in 118 S. aureus strains originating from diagnostic mastitis milk samples from 118 different farms experiencing S. aureus mastitis. MRSA strains were characterized by disk diffusion susceptibility testing, spa-typing, MLST and SCCmec-typing. In an additional study, four MRSA-positive farms were selected to assess the in-herd prevalence of MRSA, by sampling all cows in lactation. Isolated MRSA strains were similarly characterized.


The mecA gene was detected in 11 (9.3%) of the 118 S. aureus isolates, indicating that nearly 10% of the Belgian farms suffering from S. aureus mastitis have an MRSA problem. The in-herd prevalence varied between 0% and 7.4%. Characterization of the MRSA strains showed that they were all resistant to tetracycline. Additional resistances to macrolides, lincosamides and aminoglycosides were frequently detected. The strains were ST398, spa-types t011 or t567 and had SCCmec-type IVa or V, proving that they belong to the emerging livestock-associated MRSA (LA-MRSA) strains of CC398.


Our study shows that after detection in Belgian pigs, horses and poultry, LA-MRSA has also attained Belgian cattle. It is the first report on frequent isolation of LA-MRSA from bovine infections. As the in-herd isolation rate resembles that of regular S. aureus in farms experiencing S. aureus mastitis, the multi-resistance of LA-MRSA strains may cause future treatment problems.


Keywords: Methicillin-resistant Staphylococcus aureus; MRSA; Mastitis; Belgium; ST398; Multidrug resistance


http://www.sciencedirect.com/


High occurrence of methicillin-resistant Staphylococcus aureus ST398 in equine nasal samples


A. Van den Eedea, , , A. Martensa, U. Lipinskab, M. Struelensc, A. Deplanoc, O. Denisc, F. Haesebrouckb, F. Gasthuysa and K. Hermansb

aDepartment of Surgery and Anaesthesiology of Domestic Animals, Ghent University, Faculty of Veterinary Medicine, Salisburylaan 133, B-9820 Merelbeke, Belgium


bDepartment of Pathology, Bacteriology and Poultry Diseases, Ghent University, Faculty of Veterinary Medicine, Salisburylaan 133, B-9820 Merelbeke, Belgium


cLaboratoire de Référence MRSA-Staphylocoques, Department of Microbiology, Université Libre de Bruxelles, Hôpital Erasme, Route de Lennik 808, B-1070 Brussels, Belgium


Received 30 March 2008; revised 23 June 2008; accepted 26 June 2008. Available online 5 July 2008.


Abstract


Methicillin-resistant Staphylococcus aureus (MRSA) infections do occur in equine patients. Little is known, however, about their origin and the general equine MRSA colonization status. In West European horses in particular, neither the colonization rate nor the present strains or their antimicrobial susceptibility patterns are known.


In the present study, a sample of 110 (Belgian, French, Dutch and Luxemburg) horses presented at a Belgian equine clinic was screened for nasal MRSA carriage. An indirect culturing protocol using a 0.001% colistin and nalidixic acid containing broth was compared to a direct agar method. Phenotypic identification following growth on a chromogenic MRSA screening agar (ChromID™ MRSA) was combined with genotypic analysis (PCR, PFGE, SCCmec, spa, and MLST typing). Antimicrobial susceptibility was tested through disk diffusion.


Twelve (10.9%) horses carried MRSA, with the enrichment protocol resulting in a significantly higher isolation rate. None of the isolated strains were typeable through SmaI PFGE. They all harboured SCCmec type IVa or V and belonged to spa type t011 or t1451 of the ST398 lineage. All isolates were tetracycline resistant and sulfonamide and enrofloxacin susceptible. Macrolide, lincosamide, trimethoprim and aminoglycoside susceptibility varied and in total five different antimicrobial resistance patterns were distinguished.


These results show that ST398 is certainly present in West European horses. Due to its known interspecies transmission and the structure of the equine industry, the presence of this clone in horses poses a substantial health hazard for both animals and humans.


Keywords: Staphylococcus aureus; MRSA; Horse; Nasal colonization, ST398


http://www.sciencedirect.com/


Veterinary Microbiology Volume 141, Issues 1-2, 24 February 2010, Pages 96-102


Methicillin-resistant Staphylococcus aureus in horses and horse personnel: An investigation of several outbreaks


E. van Duijkerena, , , M. Molemanb, M.M. Sloet van Oldruitenborgh-Oosterbaanb, J. Multema, A. Troelstrac, A.C. Fluitc, W.J.B. van Wameld, D.J. Houwersa, A.J. de Neelinge and J.A. Wagenaara, f


a Department of Infectious Diseases and Immunology, Faculty of Veterinary Medicine, PO Box 80165, 3508 TD Utrecht, Utrecht University, The Netherlands


b Department of Equine Medicine, Faculty of Veterinary Medicine, Utrecht University, The Netherlands


c Department of Medical Microbiology, University Medical Center Utrecht, Utrecht University, The Netherlands


d Department of Medical Microbiology and Infectious Diseases, Erasmus Medical Center, Rotterdam, The Netherlands


e National Institute of Public Health and the Environment, Laboratory for Infectious Diseases and Screening, Bilthoven, The Netherlands


f Central Veterinary Institute of Wageningen UR, Lelystad, The Netherlands


Received 29 May 2009; revised 9 July 2009; accepted 3 August 2009. Available online 8 August 2009.


Abstract


At the Veterinary Microbiological Diagnostic Center, the Netherlands, the percentage of methicillin-resistant Staphylococcus aureus (MRSA) isolates found in equine clinical samples increased from 0% in 2002 to 37% in 2008. MRSA of spa-type t064, belonging to MLST ST8 and spa-types t011 and t2123, both belonging to the livestock-associated MLST ST398, predominated.


During an outbreak of post-surgical MRSA infections in horses at a veterinary teaching hospital in 2006/2007, MRSA isolates of spa-type t2123 were cultured from 7 horses and 4/61 personnel which indicated zoonotic transmission. After intervention the outbreak stopped. However, another outbreak occurred in 2008, where 17 equine MRSA isolates of spa-type t011 (n = 12), t2123 (n = 4), and t064 (n = 1) were found. This time, 16/170 personnel were positive for MRSA with spa-type t011 (n = 11) and t2123 (n = 5). Personnel in close contact with horses were more often MRSA-positive (15/106) than those without (1/64).


Screening of horses upon admission showed that 9.3% were MRSA-positive predominantly with spa-type t011. Weekly cross-sectional sampling of all hospitalized horses for 5 weeks showed that 42% of the horses were MRSA-positive at least once, again predominantly with spa-type t011, which suggests that nosocomial transmission took place. Fifty-three percent of the environmental samples were MRSA-positive, including samples from students’ and staff members’ rooms, and all were spa-type t011. This indicates that humans contribute to spreading the organism. Culturing of samples employing high-salt pre-enrichment performed better than a comparable method without pre-enrichment.


Our results show that nosocomial transmission occurs in equine clinics and suggests that personnel play a role in the transmission.


Keywords: Horse; MRSA; Staphylococcus aureus; Transmission; Environment


http://www.sciencedirect.com/


Preventive Veterinary Medicine Volume 91, Issues 2-4, 1 October 2009, Pages 270-273


Short communication


Occurrence of methicillin-resistant Staphylococcus aureus in rats living on pig farms


A.W. van de Giessen, a, , M.G. van Santen-Verheuvela, P.D. Hengevelda, T. Boscha, E.M. Broensa and C.B.E.M. Reuskena


aCentre for Infectious Disease Control Nertherlands, National Institute for Public Health and the Environment, Bilthoven, The Netherlands


Received 20 March 2009; revised 8 May 2009; accepted 8 May 2009. Available online 11 June 2009.


Abstract


In The Netherlands, MRSA ST398 has emerged in hospitals and human carriers have been associated with exposure to pigs and cattle. High prevalences of MRSA ST398 in pigs and pig farmers have been determined and the transmission routes of MRSA on pig farms need to be elucidated. In the south of the Netherlands, in recent years, the black rat (Rattus rattus) has emerged as a prominent rodent on livestock farms. From March till May 2008, a survey on MRSA in rats living on livestock farms in the south of The Netherlands and the north of Belgium was conducted. In total, 40 black rats (R. rattus) and 3 brown rats (Rattus norvegicus) were collected on 12 farms including five pig farms, five poultry farms, one mixed pig and veal farm and one goat farm. MRSA ST398 was detected in black rats captured at two of the five pig farms as well as in a black rat living on the mixed pig and veal farm. From one black rat captured at another pig farm MRSA ST 97 was isolated. Considering the behaviour of rats on livestock farms, it is concluded that rats might play a role in the spread and persistence of MRSA on pig farms.


Keywords: Staphylococcus aureus; Methicillin resistance; Swine; Transmission; Rats; Rodents


Article Outline


http://www.sciencedirect.com/


JAC Advance Access originally published online on October 21, 2009 Journal of Antimicrobial Chemotherapy 2009 64(6):1325-1326; doi:10.1093/jac/dkp378 © The Author 2009. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org


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Research letters


Detection of methicillin-resistant Staphylococcus aureus ST398 in food samples of animal origin in Spain



Carmen Lozano, María López, Elena Gómez-Sanz, Fernanda Ruiz-Larrea, Carmen Torres and Myriam Zarazaga* Departamento de Agricultura y Alimentación, Universidad de La Rioja, Madre de Dios 51, 26006 Logroño, Spain



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



* Corresponding author. Tel: +34-941-299751; Fax: +34-941-299721; E-mail: myriam.zarazaga@unirioja.es


Keywords: MRSA , food microbiology , ST398 , ST125 , ST217



Sir, Methicillin-resistant Staphylococcus aureus (MRSA) strains belonging to clonal lineage sequence type (ST) 398 are being reported at an increasing frequency in Europe.1 This new MRSA type has been isolated from colonized and infected animals and humans, and also from meat in some countries,1,2 representing a risk to human health; nevertheless, so far, no data about detection of MRSA ST398 in food in Spain have been published.



http://jac.oxfordjournals.org/cgi/content/extract/64/6/1325



doi:10.1016/j.ijfoodmicro.2008.12.007 How to Cite or Link Using DOI Copyright © 2008 Elsevier B.V. All rights reserved.



Prevalence of methicillin-resistant Staphylococcus aureus in meat



E. de Boera, , , J.T.M. Zwartkruis-Nahuisa, B. Wita, X.W. Huijsdensc, A.J. de Neelingc, T. Boschc, R.A.A. van Oosteromb, A. Vilaa and A.E. Heuvelinka


aFood and Consumer Product Safety Authority (VWA), PO Box 202, 7200 AE Zutphen, The Netherlands


bFood and Consumer Product Safety Authority (VWA), PO Box 19506, 2500 CM Den Haag, The Netherlands


cNational Institute for Public Health and the Environment (RIVM), PO Box 1, 3720 BA Bilthoven, The Netherlands


Received 13 August 2008; revised 18 November 2008; accepted 7 December 2008. Available online 13 December 2008.


Abstract


Recently the isolation of methicillin-resistant Staphylococcus aureus (MRSA) strains from several food-producing animals has been reported. During slaughtering of MRSA-positive animals, contamination of carcasses with MRSA may occur and consequently the meat of these animals may get contaminated. The aim of this study was to estimate the prevalence of MRSA in raw meat samples from the retail trade.


Samples of raw beef, pork, veal, lamb/mutton, chicken, turkey, fowl and game were collected from the retail trade. A detection method including a two-step enrichment in Mueller–Hinton broth + 6.5% NaCl and phenol red mannitol broth containing ceftizoxime and aztreonam, followed by isolation on MRSA ID agar (bioMérieux) was evaluated and subsequently applied for the detection of MRSA in samples of raw meats.


MRSA strains were isolated from 264 (11.9%) of 2217 samples analyzed. Isolation percentages for the meat species were: beef (10.6%), veal (15.2%), lamb and mutton (6.2%), pork (10.7%), chicken (16.0%), turkey (35.3%), fowl (3.4%) and game (2.2%). The majority (85%) of the isolated strains belonged to spa-types of pulsed-field gel electrophoresis (PFGE) non-typeable (NT)-MRSA, corresponding to the multilocus sequence type ST398, a type also recently isolated in the Netherlands from pigs. However, a smaller part of these strains were found to be of other ST's, possibly of human origin.



Further studies are needed to elucidate transmission routes of MRSA in relation to meat and other foods and to provide the tools for preventing the spread of MRSA. At present the high prevalence of MRSA in meat has not been shown to contribute significantly to the dissemination of MRSA to humans and the possible health hazard for consumers of the presence of MRSA in foods should be further elucidated.


Keywords: MRSA; Meat; MLST; spa-Typing


http://www.sciencedirect.com/



Thursday, February 11, 2010



Denmark's Case for Antibiotic-Free Animals NEW YORK, Feb. 10, 2010


snip...



According to one study, when different countries introduced certain antibiotics on farms, a surge occurred in people contracting antibiotic resistant intestinal infections one to two years later. One infection, Campylobacter, increased 20 percent in Denmark and 70 percent in Spain.


After the ban, a Danish study confirmed that removing antibiotics from farms drastically reduced antibiotic-resistant bacteria in animals and food.


Danish scientists believe if the U.S. doesn't stop pumping its farm animals with antibiotics, drug-resistant diseases in people will only spread.


"It's not going to be a time bomb that goes off like this," said Dr. Frank Aarestrup, of the Danish Food Institute at the University of Denmark. "It's something that's slowly getting more and more complicated, more difficult for us to actually treat infections.


Rep. Slaughter's "Preservation of Antibiotics for Medical Treatment Act" Some American food producers agree. "It's just gone too far," said Stephen McDonnell, CEO Applegate Farms.


snip...


see full text ;


http://staphmrsa.blogspot.com/2010_02_01_archive.html



Friday, January 29, 2010 14th International Congress on Infectious Diseases H-type and L-type Atypical BSE January 2010 (special pre-congress edition)



http://bse-atypical.blogspot.com/2010/01/14th-international-congress-on.html



*** CJD USA RISING, with UNKNOWN PHENOTYPE ;


5 Includes 41 cases in which the diagnosis is pending, and 17 inconclusive cases; 6 Includes 46 cases with type determination pending in which the diagnosis of vCJD has been excluded.


http://www.cjdsurveillance.com/pdf/case-table.pdf



Saturday, January 2, 2010

Human Prion Diseases in the United States January 1, 2010 ***FINAL***


http://prionunitusaupdate2008.blogspot.com/2010/01/human-prion-diseases-in-united-states.html



my comments to PLosone here ;


http://www.plosone.org/annotation/listThread.action?inReplyTo=info%3Adoi%2F10.1371%2Fannotation%2F04ce2b24-613d-46e6-9802-4131e2bfa6fd&root=info%3Adoi%2F10.1371%2Fannotation%2F04ce2b24-613d-46e6-9802-4131e2bfa6fd



Thursday, February 4, 2010

SPONGIFORM ENCEPHALOPATHY ADVISORY COMMITTEE Draft Minutes of the 103rd Meeting held on 24th November 2009


http://seac992007.blogspot.com/2010/02/spongiform-encephalopathy-advisory.html



Friday, February 05, 2010

New Variant Creutzfelt Jakob Disease case reports United States 2010 A Review


http://vcjd.blogspot.com/2010/02/new-variant-creutzfelt-jakob-disease.html



Wednesday, February 10, 2010

NAIS MAD COW TRACEABILITY DUMPED BY USDA APHIS 2010


http://naiscoolyes.blogspot.com/2010/02/nais-mad-cow-traceability-dumped-by.html





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

Tuesday, December 1, 2009

EFSA publishes results of the first survey on MRSA in pigs in the EU

Press Release 24 November 2009 EFSA publishes results of the first survey on MRSA in pigs in the EU

The European Food Safety Authority (EFSA) has published the first EU-wide survey on MRSA (Methicillin-resistant Staphylococcus aureus) in breeding pigs. The results indicate that MRSA, a bacterium resistant to many antibiotics, is commonly detected in holdings with breeding pigs in some EU Member States. The survey provides estimates of its occurrence and makes recommendations for further monitoring and investigation of the causes and implications of MRSA findings in pig holdings in the EU. The survey was carried out in 24 Member States[1], 17 of which found some type of MRSA in their holdings with breeding pigs and 7 none at all. On average, different types of MRSA were found in 1 out of 4 holdings with breeding pigs across the EU, but the survey also says that figures vary greatly between Member States. MRSA ST398 was the most reported type of MRSA among the holdings with breeding pigs in the EU; some Member States also reported other types, but their prevalence was much lower[2].

MRSA is a major concern for public health and its various types are recognised as an important cause of hospital-acquired (or nosocomial) infections in humans. The specific type MRSA ST398 has been identified in some domestic animals and is considered an occupational health risk for farmers, veterinarians and their families, who may become exposed to it through direct or indirect contact with these animals. In an opinion published earlier this year, EFSA’s Biological Hazards (BIOHAZ) Panel assessed the public health significance of MRSA in animals and food[3] and concluded that the MRSA ST398[4] strain is less likely to contribute to the spread of MRSA in hospitals than other types carried by humans. The Panel also said that there is currently no evidence that MRSA ST398 can be transmitted to humans by eating or handling contaminated food.

In the survey published today, EFSA recommends monitoring of pigs and other food producing animals for MRSA. It also says further research should be carried out, so that the reasons for differences in the prevalence of MRSA in the various Member States can be identified and used to propose options on possible control measures.

_________________________________________ Note to editors:

The Staphylococcus aureus is a bacterium that can be persistently or intermittently carried by healthy humans and is a very common cause of minor skin infections that usually do not require treatment. In patients in hospitals, Staphylococcus aureus is a common cause of hospital-acquired infections. Its variant Methicillin-Resistant Staphylococcus aureus (MRSA) emerged in the 1970s and is now often found in hospitals in many European Member States. MRSA is resistant to many commonly used antibiotics. In recent years, clones of MRSA have evolved outside the hospitals, causing infections among people who have no connection with hospitals. Most recently MRSA has also been detected in several farm animal species.

EFSA’s Zoonoses Unit monitors and analyses the situation on zoonoses, zoonotic agents, antimicrobial resistance, microbiological contaminants and food-borne outbreaks across Europe. The Unit is supported by a Task Force on Zoonoses Data Collection consisting of a pan-European network of national representatives of Member States, other reporting countries, as well as World Health Organisation (WHO) and World organisation for animal health (OIE). They gather each year data in their respective countries.

EFSA’s BIOHAZ Panel provides scientific advice on biological hazards in relation to food safety and food-borne diseases. This covers food-borne zoonoses (animal diseases transmissible to humans), Transmissible spongiform Encephalopathies (BSE/TSEs), food microbiology, food hygiene and associated waste management issues. The Panel’s risk assessment work helps to provide a sound foundation for European policies and legislation and supports risk managers in taking effective and timely decisions.

Analysis of the baseline survey on the prevalence of methicillin-resistant Staphylococcus aureus (MRSA) in holdings with breeding pigs, in the EU, 2008 [1] - Part A: MRSA prevalence estimates

EFSA’s previous work on MRSA:

EFSA’s BIOHAZ Panel “Assessment of the Public Health significance of Methicillin-resistant Staphylococcus aureus (MRSA) in animals and foods” Joint scientific report of ECDC, EFSA and EMEA on Methicillin-resistant Staphylococcus aureus (MRSA) in livestock, companion animals and food

Joint Opinion of ECDC, EFSA, EMEA and SCENIHR on antimicrobial resistance (AMR) focused on zoonotic infections

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[1] The sampling took place during 2008. Dust samples were taken in the environment of pigs in a total of 5,073 holdings from 24 EU Member States and two non-Member States. The pooled sample of each holding was tested for the presence of the various MRSA strains. [2] Only six Member States and one non-Member State reported MRSA non-ST398 in the holdings with breeding pigs. The prevalence of MRSA non-ST398 in holdings with breeding pigs across the participating Member States was substantially lower than the prevalence of MRSA and MRSA ST398. [3] EFSA’s BIOHAZ Panel opinion on the “Assessment of the Public Health significance of Methicillin-resistant Staphylococcus aureus (MRSA) in animals and foods” of March 2009 [4] In its opinion the BIOHAZ Panel refers to CC398 which corresponds to MRSA ST398.



http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1211903070258.htm



http://staphmrsa.blogspot.com/




TSS

Friday, January 23, 2009

Methicillin-Resistant Staphylococcus aureus (MRSA) Strain ST398 Is Present in Midwestern U.S. Swine and Swine Workers

Methicillin-Resistant Staphylococcus aureus (MRSA) Strain ST398 Is Present in Midwestern U.S. Swine and Swine Workers

Tara C. Smith1,2*, Michael J. Male1,2, Abby L. Harper1,2, Jennifer S. Kroeger3, Gregory P. Tinkler2, Erin D. Moritz1,2, Ana W. Capuano1,2, Loreen A. Herwaldt1,3,4, Daniel J. Diekema3,4,5

1 Department of Epidemiology, University of Iowa College of Public Health, Iowa City, Iowa, United States of America, 2 Center for Emerging Infectious Diseases, University of Iowa College of Public Health, Iowa City, Iowa, United States of America, 3 Department of Medicine, University of Iowa Carver College of Medicine, Iowa City, Iowa, United States of America, 4 Program of Hospital Epidemiology, University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States of America, 5 Department of Pathology, University of Iowa Carver College of Medicine, Iowa City, Iowa, United States of America

Abstract Background Recent research has demonstrated that many swine and swine farmers in the Netherlands and Canada are colonized with MRSA. However, no studies to date have investigated carriage of MRSA among swine and swine farmers in the United States (U.S.).

Methods We sampled the nares of 299 swine and 20 workers from two different production systems in Iowa and Illinois, comprising approximately 87,000 live animals. MRSA isolates were typed by pulsed field gel electrophoresis (PFGE) using SmaI and EagI restriction enzymes, and by multi locus sequence typing (MLST). PCR was used to determine SCCmec type and presence of the pvl gene.

Results In this pilot study, overall MRSA prevalence in swine was 49% (147/299) and 45% (9/20) in workers. The prevalence of MRSA carriage among production system A's swine varied by age, ranging from 36% (11/30) in adult swine to 100% (60/60) of animals aged 9 and 12 weeks. The prevalence among production system A's workers was 64% (9/14). MRSA was not isolated from production system B's swine or workers. Isolates examined were not typeable by PFGE when SmaI was used, but digestion with EagI revealed that the isolates were clonal and were not related to common human types in Iowa (USA100, USA300, and USA400). MLST documented that the isolates were ST398.

Conclusions These results show that colonization of swine by MRSA was very common on one swine production system in the midwestern U.S., suggesting that agricultural animals could become an important reservoir for this bacterium. MRSA strain ST398 was the only strain documented on this farm. Further studies are examining carriage rates on additional farms.

Citation: Smith TC, Male MJ, Harper AL, Kroeger JS, Tinkler GP, et al. (2008) Methicillin-Resistant Staphylococcus aureus (MRSA) Strain ST398 Is Present in Midwestern U.S. Swine and Swine Workers. PLoS ONE 4(1): e4258. doi:10.1371/journal.pone.0004258

Editor: Ulrich Dobrindt, University of Würzburg, Germany

Received: October 9, 2008; Accepted: December 19, 2008; Published: January 23, 2008

Copyright: © 2009 Smith et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Funding: This study was funded with departmental startup funds (TCS). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing interests: The authors have declared that no competing interests exist.

* E-mail: tara-smith@uiowa.edu

Introduction ...snip...end

see full text ;


http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0004258


MRSA

http://staphmrsa.blogspot.com/