MRSA

Occurrence and distribution of Staphylococcus aureuslineages among zoo animals

2012-02-09T13:47:00.000-08:00

Occurrence and distribution of Staphylococcus aureus lineages among zoo animals

Original Research Article

In Press, Accepted Manuscript, Available online 2 February 2012

Carmen Espinosa-Gongora, Dorota Chrobak, Arshnee Moodley, Mads Frost Bertelsen, Luca Guardabassi

Abstract

The current knowledge of the occurrence and diversity of Staphylococcus aureus in animals is largely biased in favour MRSA and domestic animals. In order to generate novel information on the ecology and population structure of this bacterial species in the animal kingdom, we investigated the occurrence and genotypic diversity of S. aureus in a range of animal species kept at the Copenhagen Zoo. We sampled 146 animals belonging to 25 mammalian species and 21 reptiles belonging to six species. A total of 59 S. aureus isolates were found in 10 of the 25 mammalian species tested. All isolates were MSSA belonging to fourteen spa types, including three novel spa types. MLST revealed the occurrence of seven STs. The study of the ecology of commensal S. aureus in captive wild animals revealed that ST133 has a broader host range than previously thought.

http://www.sciencedirect.com/science/journal/aip/03781135

Thursday, June 9, 2011

New Superbug Found in Cows and People

http://staphmrsa.blogspot.com/2011/06/new-superbug-found-in-cows-and-people.html

Wednesday, May 11, 2011

Methicillin-resistant Staphylococcus aureus in Retail Meat, Detroit, Michigan, USA

http://staphmrsa.blogspot.com/2011/05/methicillin-resistant-staphylococcus.html

Monday, April 18, 2011

Multidrug-Resistant Staphylococcus aureus in US Meat and Poultry

http://staphmrsa.blogspot.com/2011/04/multidrug-resistant-staphylococcus.html

http://staphmrsa.blogspot.com/

TSS

In-feed antibiotic effects on the swine intestinal microbiome

2012-01-17T19:40:00.001-08:00

In-feed antibiotic effects on the swine intestinal microbiome

Torey Loofta,1, Timothy A. Johnsonb,c,1, Heather K. Allena,1, Darrell O. Baylesa, David P. Alta, Robert D. Stedtfeldb,d, Woo Jun Sulb,c, Tiffany M. Stedtfeldb, Benli Chaib, James R. Coleb, Syed A. Hashshamb,d, James M. Tiedjeb,c,2, and Thad B. Stantona,2 aAgricultural Research Service, National Animal Disease Center, US Department of Agriculture, Ames, IA 50010; and bCenter for Microbial Ecology, cDepartment of Crop and Soil Science, and dDepartment of Civil and Environmental Engineering, Michigan State University, East Lansing, MI 48823

Contributed by James M. Tiedje, December 19, 2011 (sent for review July 12, 2011)

Antibiotics have been administered to agricultural animals for disease treatment, disease prevention, and growth promotion for over 50 y. The impact of such antibiotic use on the treatment of human diseases is hotly debated. We raised pigs in a highly controlled environment, with one portion of the littermates receiving a diet containing performance-enhancing antibiotics [chlortetracycline, sulfamethazine, and penicillin (known as ASP250)] and the other portion receiving the same diet but without the antibiotics. We used phylogenetic, metagenomic, and quantitative PCR-based approaches to address the impact of antibiotics on the swine gut microbiota. Bacterial phylotypes shifted after 14 d of antibiotic treatment, with the medicated pigs showing an increase in Proteobacteria (1–11%) compared with nonmedicated pigs at the same time point. This shift was driven by an increase in Escherichia coli populations. Analysis of the metagenomes showed that microbial functional genes relating to energy production and conversion were increased in the antibiotic-fed pigs. The results also indicate that antibiotic resistance genes increased in abundance and diversity in the medicated swine microbiome despite a high background of resistance genes in nonmedicated swine. Some enriched genes, such as aminoglycoside O-phosphotransferases, confer resistance to antibiotics that were not administered in this study, demonstrating the potential for indirect selection of resistance to classes of antibiotics not fed. The collateral effects of feeding subtherapeutic doses of antibiotics to agricultural animals are apparent and must be considered in cost-benefit analyses.

intestinal microbiota | microbiome shifts | swine bacteria | BioTrove microarray | metagenomics

snip...

Conclusions

The results show that even a low, short-term dose of in-feed antibiotics increases the abundance and diversity of antibiotic resistance genes, including resistance to antibiotics not administered, and increases the abundance of E. coli, a potential human pathogen. Additionally, analysis of the metagenomes implicated functions potentially involved with improved feed efficiency. The study design featured environmental control in a single uniform inoculum source (the mother), control of the host genetics, no exposure of the sow or piglets to antibiotics except for the treatment, and identical diet except for the inclusion of ASP250 in one group. Future studies should include other in-feed antibiotics, multiple litters of swine with robust replication, and the identification of the antibiotic-induced mechanisms that lead to increased feed efficiency. Implications of antibiotic resistance on human and animal health need to be taken into account when discussing agricultural management policies and evaluating alternatives to traditional antibiotics. With the use of antibiotics in animal agriculture at a crossroads, studies like this and others that highlight the collateral effects of antibiotic use are needed.

http://news.msu.edu/media/documents/2012/01/23219e73-d86c-49b3-a4d0-ae4effc5d55c.pdf

Study provides new insights into antibiotics and pig feeds Contact: Layne Cameron, University Relations, Office: (517) 353-8819, Cell: (765) 748-4827, layne.cameron@ur.msu.edu; Thad Stanton, USDA-ARS National Animal Disease Center, Office: (515) 337-7244, thad.stanton@ars.usda.gov; James Tiedje, Crop and Soil Sciences, Office: (517) 355-0271, ext. 1287, tiedjej@msu.edu

Published: Jan. 16, 2012 E-mail Editor ShareThis

Jim Tiedje, University Distinguished professor of microbiology and molecular genetics, is the co-author of a comprehensive study on antibiotics use in pig feed. Photo by Kurt Stepnitz.

Antibiotics in pig feed are increasing antibiotic resistance genes in gastronintestinal microbes in pigs. Photo courtesy of MSU.

Click on an image to view a larger or high-resolution version.

Related Links PNAS paper (opens in new window) EAST LANSING, Mich. — Antibiotics in pig feed increased the number of antibiotic resistant genes in gastrointestinal microbes in pigs, according to a study conducted by Michigan State University and the U.S. Department of Agriculture’s Agricultural Research Service.

Published in the current edition of the Proceedings of the National Academy of Sciences, the comprehensive study focused on understanding the effects of conventional, in-feed antibiotics in U.S. farms.

For decades, many producers of pigs, chickens and other farm animals have used antibiotics not only to protect their livestock from disease, but also to boost growth rates and enhance feed efficiency, a measure of how well animals convert feed into weight gains.

Scientists don’t know precisely how antibiotics enhance growth rates and feed efficiency, but they are concerned that on-farm use of these medications may contribute to the development of strains of microbes resistant to conventional antibiotics, which are potentially harmful to humans and animals, said James Tiedje, MSU University Distinguished Professor of microbiology and molecular genetics and of crop and soil sciences.

“The growth of antibiotic resistance in pathogens is a huge challenge for society around the world,” said Tiedje, an MSU AgBioResearch scientist. “Studies to understand what contributes to the spread and what interventions can help control the problem are vital.”

Additional findings include:

Both diversity and abundance of antibiotic resistance genes increased in the intestinal microbial communities of the pigs treated with antibiotics. Longer term studies are needed. Some of the genes found in the treated pigs were unexpected and usually linked to antibiotics not used in the study. Microbial genes associated with production and use of energy by microbes increased in abundance in the antibiotic-fed pigs, which may shed light on how antibiotics increase livestock growth and feed efficiency. E. coli populations increased in the intestines of the treated pigs. Further study is needed to clarify this observation. “To our knowledge, this study is the first of its kind to look at the collateral impacts of in-feed antibiotic use in farm animals, using a comprehensive approach to detect shifts in the function and the makeup or membership of the microbial community in the model animal’s gastrointestinal tract,” said Torey Looft, USDA researcher.

Additional MSU researchers included Tim Johnson, doctoral student; Robert Stedtfeld, civil and environmental engineering research associate; Woo Jun Sul, doctoral student; Tiffany Stedtfeld, civil and environmental engineering technical aide; Benli Chai, information technologist, Center for Microbial Ecology; James Cole, assistant professor at the Center for Microbial Ecology; and Syed Hashsham, civil and environmental engineering professor.

Funding was provided by MSU’s Environmental Science and Policy Program initiative on Pharmaceuticals in the Environment, ARS and the National Institutes of Health and through the Alliance for the Prudent Use of Antibiotics program on Reservoirs of Antibiotic Resistance.

###

Michigan State University has been working to advance the common good in uncommon ways for more than 150 years. One of the top research universities in the world, MSU focuses its vast resources on creating solutions to some of the world’s most pressing challenges, while providing life-changing opportunities to a diverse and inclusive academic community through more than 200 programs of study in 17 degree-granting colleges.

As the USDA’s chief scientific research agency, ARS is leading America toward a better future through agricultural research and information. ARS conducts research to develop and transfer solutions to help answer agricultural questions that impact Americans every day.

http://news.msu.edu/story/10214/

Thursday, June 9, 2011

New Superbug Found in Cows and People

http://staphmrsa.blogspot.com/2011/06/new-superbug-found-in-cows-and-people.html

Wednesday, May 11, 2011

Methicillin-resistant Staphylococcus aureus in Retail Meat, Detroit, Michigan, USA

http://staphmrsa.blogspot.com/2011/05/methicillin-resistant-staphylococcus.html

Monday, April 18, 2011

Multidrug-Resistant Staphylococcus aureus in US Meat and Poultry

http://staphmrsa.blogspot.com/2011/04/multidrug-resistant-staphylococcus.html

http://staphmrsa.blogspot.com/

TSS

New Superbug Found in Cows and People

2011-06-09T14:22:00.000-07:00

New Superbug Found in Cows and People

by Jocelyn Kaiser on 2 June 2011, 6:30 PM|

A novel form of deadly drug-resistant bacteria that hides from a standard test has turned up in Europe. Researchers found the so-called MRSA strain in both dairy cows and humans in the United Kingdom, suggesting that it might be passed from dairies to the general population. But before you toss your milk, don't panic: The superbug isn't a concern in pasteurized dairy products.

MRSA, short for methicillin-resistant Staphylococcus aureus, is a drug-resistant form of the widespread and normally harmless S. aureus bacteria. Many people walk around with MRSA in their noses or on their skin yet don't get sick. But in some hospital patients and people with weakened immune systems, MRSA thrives, and it is blamed for about 19,000 hospital deaths a year in the United States.

Mark Holmes of the University of Cambridge in the United Kingdom and colleagues stumbled upon the new strain while studying mastitis, or infected udders, in U.K. dairy cows. Some milk samples from sick cows contained S. aureus bacteria that grew in the presence of antibiotics, which is one test for MRSAs. Yet the same samples turned up negative for the drug-defying bacterium when the team used PCR, a DNA amplification technique, to detect a gene called mecA, which is found in all MRSA strains.

The PCR test doesn't always pick up variants of the gene it's meant to detect, however. To check this, the researchers sent a cow S. aureus sample to the Wellcome Trust Sanger Institute in Cambridge, which sequenced the bacterium's entire genome. "Lo and behold, there was a mecA gene there," one whose sequence overlapped with the better-known mecA by a surprisingly low 60%, Holmes said today in a press conference.

The researchers then looked for this mecA gene in people. They tested 74 samples of S. aureus isolated from people from the United Kingdom and Denmark that were drug resistant in the antibiotic growth test but not in the PCR test—most from carriers but some from patients who were sickened by MRSA. They found the new mecA in about two-thirds of the samples, they report today in The Lancet Infectious Diseases. A nearly identical mecA gene has also now been reported in human samples from Germany and Ireland.

The strain is still relatively rare—it probably makes up less than 1% of all detected MRSA cases, the U.K. team says. But its prevalence appears to have risen in the past decade. "More likely it's been around in the environment for a long time, and it's just getting into the human population," says University College Dublin microbiologist David Coleman, whose team reports on the Irish samples today in Antimicrobial Agents and Chemotherapy.

The new superbug probably isn't leading to missed infections, at least in the United Kingdom, because hospitals that suspect a patient is infected with an MRSA nearly always use the antibiotic growth test in addition to PCR, Holmes says. (Patients with a confirmed infection then receive antibiotics that work on MRSAs.) However, many hospitals in continental Europe are moving toward using only PCR tests; this is a warning that those tests need to be modified to test for the new mecA gene, Holmes says.

The study also points to dairy cows as a possible reservoir for the bug, just as pigs seem to pass MRSA to humans in the Netherlands. The bug probably doesn't get to humans through the milk supply, because almost all milk in the United Kingdom and Denmark is pasteurized, a process that kills bacteria. But workers who come into contact with infected dairy cows could be carriers. Holmes's team reports "circumstantial evidence" for this, such as the fact that genetic subtypes of the human and cow samples from the same geographical areas were nearly identical. "The main worry would be that these cows represent a pool of the bacteria" that farm workers spread into the human population, Holmes says.

The big mystery, says Patrick Schlievert of the University of Minnesota, Twin Cities, is where the unusual mecA gene came from. One possibility is that it originated long ago in a patient treated with multiple antibiotics and later somehow got into cows. "This should trigger an awful lot of research to figure out what is going on here," he says.

http://news.sciencemag.org/sciencenow/2011/06/new-superbug-found-in-cows-and-p.html?ref=hp

The Lancet Infectious Diseases, Early Online Publication, 3 June 2011

doi:10.1016/S1473-3099(11)70126-8Cite or Link Using DOI

Meticillin-resistant Staphylococcus aureus with a novel mecA homologue in human and bovine populations in the UK and Denmark: a descriptive study

Laura García-Álvarez PhD a, Matthew TG Holden PhD b, Heather Lindsay BSc a, Cerian R Webb PhD a, Derek FJ Brown PhD c, Martin D Curran PhD c, Enid Walpole FIMLS c, Karen Brooks BSc b, Derek J Pickard PhD b, Christopher Teale MRCVS d, Prof Julian Parkhill PhD b, Stephen D Bentley PhD b, Giles F Edwards FRCPath e, E Kirsty Girvan MSc e, Angela M Kearns PhD f, Bruno Pichon PhD f, Robert LR Hill PhD f, Anders Rhod Larsen PhD g, Robert L Skov MD g, Prof Sharon J Peacock PhD h, Prof Duncan J Maskell PhD a, Dr Mark A Holmes VetMB a

Summary

Background

Animals can act as a reservoir and source for the emergence of novel meticillin-resistant Staphylococcus aureus (MRSA) clones in human beings. Here, we report the discovery of a strain of S aureus (LGA251) isolated from bulk milk that was phenotypically resistant to meticillin but tested negative for the mecA gene and a preliminary investigation of the extent to which such strains are present in bovine and human populations.

Methods

Isolates of bovine MRSA were obtained from the Veterinary Laboratories Agency in the UK, and isolates of human MRSA were obtained from diagnostic or reference laboratories (two in the UK and one in Denmark). From these collections, we searched for mecA PCR-negative bovine and human S aureus isolates showing phenotypic meticillin resistance. We used whole-genome sequencing to establish the genetic basis for the observed antibiotic resistance.

Findings

A divergent mecA homologue (mecALGA251) was discovered in the LGA251 genome located in a novel staphylococcal cassette chromosome mec element, designated type-XI SCCmec. The mecALGA251 was 70% identical to S aureus mecA homologues and was initially detected in 15 S aureus isolates from dairy cattle in England. These isolates were from three different multilocus sequence type lineages (CC130, CC705, and ST425); spa type t843 (associated with CC130) was identified in 60% of bovine isolates. When human mecA-negative MRSA isolates were tested, the mecALGA251 homologue was identified in 12 of 16 isolates from Scotland, 15 of 26 from England, and 24 of 32 from Denmark. As in cows, t843 was the most common spa type detected in human beings.

Interpretation

Although routine culture and antimicrobial susceptibility testing will identify S aureus isolates with this novel mecA homologue as meticillin resistant, present confirmatory methods will not identify them as MRSA. New diagnostic guidelines for the detection of MRSA should consider the inclusion of tests for mecALGA251.

Funding

Department for Environment, Food and Rural Affairs, Higher Education Funding Council for England, Isaac Newton Trust (University of Cambridge), and the Wellcome Trust.

a Department of Veterinary Medicine, University of Cambridge, UK

b The Wellcome Trust Sanger Institute, Wellcome Trust Genome Campus, Cambridge, UK

c Health Protection Agency, Addenbrooke's Hospital, Cambridge, UK

d Veterinary Laboratories Agency, Shrewsbury, UK

e Scottish MRSA Reference Laboratory, NHS Greater Glasgow and Clyde, Stobhill Hospital, Glasgow, UK

f Microbiology Services Division, Health Protection Agency, London, UK

g Department of Antimicrobial Surveillance and Research, Statens Serum Institut, Copenhagen, Denmark

h Department of Medicine, University of Cambridge, Addenbrooke's Hospital, Cambridge, UK

Correspondence to: Dr Mark A Holmes, Department of Veterinary Medicine, University of Cambridge, Madingley Road, Cambridge, CB3 0ES, UK

http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(11)70126-8/abstract

http://staphmrsa.blogspot.com/

TSS

Methicillin-resistant Staphylococcus aureus in Retail Meat, Detroit, Michigan, USA

2011-05-11T20:53:00.000-07:00

DOI: 10.3201/eid1706.101095

Suggested citation for this article: Bhargava K, Wang X, Donabedian S, Zervos M, da Rocha L, Zhang Y. Methicillin-resistant Staphylococcus aureus in retail meat, Detroit, Michigan, USA [letter]. Emerg Infect Dis. 2011 Jun; [Epub ahead of print]

Methicillin-resistant Staphylococcus aureus in Retail Meat, Detroit, Michigan, USA

To the Editor: Because methicillin-resistant Staphylococcus aureus (MRSA) has been identified in retail meat worldwide (1–4), the potential exists for its transmission to humans. Of the various meat products surveyed, pork had the highest contamination rate in the United States and Canada (1,2), as did beef in Korea (3) and poultry in the Netherlands (4). The study in Korea also observed MRSA from chicken, which demonstrated sequence type (ST) 692 by multilocus sequence typing (MLST), a type distinct from that isolated in beef and pork. Despite sample size variations, these studies suggested that MRSA contamination in different meat categories can vary by location and that molecular distinction may exist among MRSA isolates in meat of different origin.

We collected 289 raw meat samples (156 beef, 76 chicken, and 57 turkey) from 30 grocery stores in Detroit, Michigan, USA, during August 2009–January 2010. Up to 3 presumptive S. aureus colonies per sample were identified by coagulase test and species-specific PCR (1). Antimicrobial drug MICs were determined and interpreted according to Clinical and Laboratory Standards Institute guidelines (5). S. aureus were characterized by pulsed-field gel electrophoresis (PFGE), mecA identification, SCCmec typing, Panton-Valentine leukocidin identification, agr typing, MLST, and spa typing as described (1,6).

Sixty-five (22.5%) samples yielded S. aureus: 32 beef (20.5%), 19 chicken (25.0%), and 14 turkey (24.6%) samples. Six samples, consisting of 2 beef (1.3%), 3 chickens (3.9%), and 1 turkey (1.7%), were positive for MRSA as evidenced by the presence of mecA. The overall lower prevalence of S. aureus and MRSA than found in a previous study in the United States (40% and 5%, respectively) (1) might be explained by our exclusion of pork because pork and swine production have been major reservoirs of MRSA (4,7). However, different geographic location Page 2 of 4

and cold sampling seasons in this study also might have caused the variations. The only multidrug-resistant MRSA isolate in this study (MRSA1) was from beef and was resistant to ß-lactams, macrolides, and fluoroquinolones (Figure).

Although an extra band was generated in MRSA2a, 2b, 3, 5, and 6 by PFGE, all 9 MRSA isolates belonged to USA300 (Figure). Multiple isolates from the same samples (MRSA2a and 2b; MRSA4a, 4b, and 4c) demonstrated indistinguishable PFGE patterns and other characteristics, which suggested identical MRSA clones. Moreover, MLST, SCCmec typing, agr typing, and pvl detection showed all strains to be positive for ST8, SCCmec IVa, agr I, and Panton-Valentine leukocidin, which are typical characteristics of USA300 clones. However, spa typing identified 2 distinct spa types, t008 (11–19–12-21–17-34–24–34–22–25) and t2031 (11–19–12-12–34-34–24–34–22–25) (repeat variants in boldface), which differed by 5 nucleotides. t008, the most common spa type of USA300, was identified in 6 isolates of beef, chicken, and turkey origin, whereas t2031 was recovered from MRSA4a, 4b, and 4c from a chicken sample. The nucleotide variation in t2031 caused amino acid changes from glycine-asparagine in t008 to asparagine-lysine. The single nucleotide difference between repeats 12 (GGT) and 21 (GGC) and repeats 34 (AAA) and 17 (AAG) resulted in no amino acid change, with glycine and lysine encoded, respectively.

Unlike studies in Europe, where researchers have reported the animal MRSA clone ST398 from various meat products (4), all MRSA isolates in our study were USA300, which suggests a possible human source of contamination during meat processing (1). The failure to identify ST398 in the US retail meat also indicates that the human MRSA clones might be better adapted in meat processing than ST398 in this country. Since ST398 is widespread in animals and meat in Europe and has been isolated from other parts of the world (8), it is not too bold to predict that ST398 might appear in US meat in the future, especially after the recent report of ST398 from US swine (7).

The 5-nt difference between t2031 and t008 implicates multiple MRSA clones in poultry. Previous studies have shown spa variants of USA300 from clinical cases associated with distinctive symptoms (9,10). A single repeat variant, t024, showed substantial genetic, epidemiologic, and clinical differences from t008 in Denmark (10). Researchers in Japan also recovered 2 spa variants of USA300: t024, which causes blood infections, and t711, which is Page 3 of 4

associated with subcutaneous abscesses (9). In both studies, t024 behaved as hospital-associated MRSA, suggesting that spa variants of USA300 could lead to different clinical outcomes. Therefore, we can reasonably assume that variants with a meat origin also might have different public health implications; further research on their virulence potential would be helpful to elucidate this possibility.

Despite the recovery of MRSA from retail chicken and t2031 that has an antibiogram distinct from t008, except for ß-lactam resistance, several questions remain about whether more spa variants are present in poultry (or meat). These include whether t2031 is more adaptable to chicken production because of the 2 amino acid difference from t008, or whether t2031 is linked with specific antimicrobial drug resistance phenotypes other than ß-lactam resistance.

Kanika Bhargava, Xiaogang Wang, Susan Donabedian, Marcus Zervos, Liziane da Rocha, and Yifan Zhang

Author affiliations: Wayne State University, Detroit, Michigan, USA (K. Bhargava, X. Wang, L. da Rocha, Y. Zhang) and Henry Ford Health Systems, Detroit (S. Donabedian, M. Zervos)

References

1. Pu S, Han F, Ge B. Isolation and characterization of methicillin-resistant Staphylococcus aureus strains from Louisiana retail meats. Appl Environ Microbiol. 2009;75:265–7. PubMed doi:10.1128/AEM.01110-08

2. Weese JS, Avery BP, Reid-Smith RJ. Detection and quantification of methicillin-resistant Staphylococcus aureus (MRSA) clones in retail meat products. Lett Appl Microbiol. 2010;51:338–42. PubMed doi:10.1111/j.1472-765X.2010.02901.x

3. Lim SK, Nam HM, Park HJ, Lee HS, Choi MJ, Jung SC, et al. Prevalence and characterization of methicillin-resistant Staphylococcus aureus in raw meat in Korea. J Microbiol Biotechnol. 2010;20:775–8. PubMed

4. de Boer E, Zwartkruis-Nahuis JT, Wit B, Huijsdens XW, de Neeling AJ, Bosch T, et al. Prevalence of methicillin-resistant Staphylococcus aureus in meat. Int J Food Microbiol. 2009;134:52–6. PubMed doi:10.1016/j.ijfoodmicro.2008.12.007

5. Clinical and Laboratory Standards Institute. Methods for dilution antimicrobial susceptibility tests for bacteria that grow aerobically, 7th ed. Wayne (PA): The Institute; 2006. Page 4 of 4

6. Strommenger B, Cuny C, Werner G, Witte W. Obvious lack of association between dynamics of epidemic methicillin-resistant Staphylococcus aureus in central Europe and agr specificity groups. Eur J Clin Microbiol Infect Dis. 2004;23:15–9. PubMed doi:10.1007/s10096-003-1046-8

7. Smith TC, Male MJ, Harper AL, Kroeger JS, Tinkler GP, Moritz ED, et al. Methicillin-resistant Staphylococcus aureus (MRSA) strain ST398 is present in midwestern U.S. swine and swine workers. PLoS ONE. 2009;4:e4258. PubMed doi:10.1371/journal.pone.0004258

8. Weese JS, Reid-Smith R, Rousseau J, Avery B. Methicillin-resistant Staphylococcus aureus (MRSA) contamination of retail pork. Can Vet J. 2010;51:749–52. PubMed

9. Higuchi W, Mimura S, Kurosawa Y, Takano T, Iwao Y, Yabe S, et al. Emergence of the community-acquired methicillin-resistant Staphylococcus aureus USA300 clone in a Japanese child, demonstrating multiple divergent strains in Japan. J Infect Chemother. 2010;16:292–7. PubMed doi:10.1007/s10156-010-0051-y

10. Larsen AR, Goering R, Stegger M, Lindsay JA, Gould KA, Hinds J, et al. Two distinct clones of methicillin-resistant Staphylococcus aureus (MRSA) with the same USA300 pulsed-field gel electrophoresis profile: a potential pitfall for identification of USA300 community-associated MRSA. J Clin Microbiol. 2009;47:3765–8. PubMed doi:10.1128/JCM.00934-09

Address for correspondence: Yifan Zhang, Department of Nutrition and Food Science, Wayne State University, 3009 Science Hall, 5045 Cass Ave, Detroit, MI 48202, USA; email: yifanzhang@wayne.edu

Figure. Dendrogram showing comparison of SmaI pulsed-field gel electrophoresis patterns, SCCmec type, PVL content, and agr type of methicillin-resistant Staphylococcus aureus (MRSA) isolated from meat samples. All MRSA isolates were resistant to ß-lactam antimicrobial drugs (ampicillin, penicillin, and oxacillin) and grew on the 6 µg/mL of cefoxitin for screening methicillin resistance. *Isolates with the same arabic numbers were from the same sample; †only resistance to non–ß-lactam antimicrobial drugs was listed. ID, identification; MLST, multilocus sequence typing; PVL, Panton-Valentine leukocidin; CIP, ciprofloxacin; ERY, erythromycin; LEVO, levofloxacin; TET, tetracycline.

http://www.cdc.gov/eid/content/17/6/pdfs/10-1905.pdf

May 11, 2011

Human-type MRSA found in Detroit raw meat

Researchers testing retail meat samples in Detroit found that almost a fourth contained Staphylococcus aureus and 2% contained methicillin-resistant S aureus (MRSA). In a letter to Emerging Infectious Diseases today, the scientists report that they collected 289 raw meat samples (156 beef, 76 chicken, and 57 turkey) from 30 grocery stores from August 2009 through January 2010. Of those samples, 65 (22.5%) yielded S aureus via coagulase test and polymerase chain reaction (PCR): 32 beef (20.5%), 19 chicken (25.0%), and 14 turkey (24.6%) samples. Six samples (2 beef [1.3%], 3 chicken [3.9%], and 1 turkey [1.7%]), were positive for MRSA, while only one sample, a beef one, contained multidrug-resistant MRSA. Furthermore, the MRSA was the human type, USA300, which the authors said could indicate a human rather than animal source of meat contamination. They said similar studies in European meat typically show ST398, an animal MRSA clone. They noted that the percentage of positive MRSA samples is lower than in an earlier study in Louisiana meat, perhaps because the Michigan researchers didn't test pork, noting that swine production has been identified as a reservoir of MRSA. They wrote that although USA300 might be better adapted to meat processing in the United States, ST398 might someday appear as a contaminant in US meat, given its recent identification in US swine.

http://www.cidrap.umn.edu/cidrap/content/fs/food-disease/news/may1111newsscan.html

Monday, April 18, 2011

Multidrug-Resistant Staphylococcus aureus in US Meat and Poultry

http://staphmrsa.blogspot.com/2011/04/multidrug-resistant-staphylococcus.html

Tuesday, May 10, 2011

Food safety for whom? Corporate wealth versus people's health

http://fdafailedus.blogspot.com/2011/05/food-safety-for-whom-corporate-wealth.html

Horizon Acres 3/18/11

Department of Health and Human Services Public Health Service Food and Drug Administration Cincinnati District Office Central Region 6751 Steger Drive Cincinnati, OH 45237-30977 Telephone: (513) 679-2700 FAX: (513) 679-2761

WARNING LETTER CIN-11-65585-06

March 18, 2011

United Parcel Service

Mr. Kenneth D. Weaver, General Manager Horizon Acres 6728 Zuercher Road

Dalton, Ohio 44618

Dear Mr. Weaver:

On November 10, 12, 19,24, 2010, and December 20, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your veal calf operation located at 6728 Zuercher Road, Dalton, Ohio 44618. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA's web page at www.fda.gov1.

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 FD&C 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 FD&C Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the FD&C 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 22, 2010, you sold an unidentified, untagged veal calf for slaughter as food. On or about June 22, 2010, (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 0.28 parts per million (ppm) of flunixin in the liver tissue. FDA has established a tolerance of 0.125 ppm for residues of flunixin in the liver of cattle as codified in 21 C.F.R. 556.286(b)(1)(i). However, this tolerance does not apply to use of Suppressor (flunixin meglumine) Injectable Solution, ANADA 200-308, in veal calves (pre-ruminating calves), and there is no acceptable level of residue associated with use of flunixin meglumine in veal calves (pre-ruminating calves). 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 FD&C 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 segregate treated animals. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4).

We also found that you adulterated the new animal drugs Suppressor (flunixin meglumine) ANADA 200-308, Dexamethasone ANADA 200-312, Ceftiflex sterile powder (ceftiofur sodium) ANADA 200-420, PennOne Pro (penicillin G procaine) NADA 65-010, Amoxicillin capsules NDC 65862-017-05, Sulfamethoxazole and Trimethoprim Double Strength tablets NDC 53746-272-05 (SMZ-TMP tablets), and Pennchlor 64 (chlortetracycline HCI) ANADA 200-295. Specifically, our investigation revealed that you did not use these drugs 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 FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C 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 flunixin meglumine to veal calves without following the withdrawal period as stated in the approved labeling. Your extralabel use of flunixin meglumine was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11(a) and your extralabel use of flunixin meglumine resulted in an illegal drug residue, in violation of 21 C.F.R. § 530.11(c).

Our investigation found that you administered dexamethasone to veal calves without following the route of administration and the withdrawal period as stated in the approved labeling. Your extralabel use of Dexamethasone was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11 (a).

Our investigation found that you administered ceftiofur sodium to veal calves without following the withdrawal period as stated in the approved labeling. Your extralabel use of ceftiofur sodium was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11(a).

Our investigation found that you administered penicillin G procaine to veal calves without following the route of administration and the withdrawal period as stated in the 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).

Our investigation found that you administered amoxicillin and sulfamethoxazole and trimethoprim (SMZ-TMP) to veal calves without following the route of administration and duration of the treatment as stated in their approved labeling. Your extralabel use of Amoxicillin and SMZ-TMP were not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11 (a) and your use of amoxicillin and SMZ-TMP in or on feed, is in violation of 21 C.F.R. § 530.11(b).

Our investigation found that you administered chlortetracycline HCI to veal calves without following the duration of treatment. Your use of chlortetracycline HCI was not under the supervision of a licensed veterinarian, and is in violation of 21 C.F.R. § 530.11

(a) and your use of pennchlor 64 in or on feed, is in violation of 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. Part 530, you caused the drug(s) to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5).

In addition, you adulterated the liquid animal feed within the meaning of section 501(a)(6) of the FD&C Act, 21 U.S.C. § 351(a)(6), when you added sulfamethoxazole and trimethoprim, Amoxicillin, and chlortetracycline HCI, and you failed to use the medicated feed in conformance with its approved labeling. Your use of this medicated feed without following the animal class as directed by the approved labeling caused this medicated feed to be unsafe under section 512(a)(2) of the FD&C Act, 21 U.S.C. § 360b(a)(2), and adulterated under section 501(a)(6) of the FD&C Act, 21 U.S.C. § 351(a)(6). Section 512 of the FD&C Act, 21 U.S.C. § 360b, and 21 C.F.R. 530.11(b) do not permit the extralabel use of medicated feed.

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 Allison C. Hunter, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions about this letter, please contact Compliance Officer Hunter at 513-679-2700 ext. 134.

Sincerely yours, /S/

Teresa Thompson District Director Cincinnati District

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm248212.htm

p.s. update prion disease ;

Sunday, May 01, 2011

STUDY OF ATYPICAL BSE 2010 Annual Report May 2011

http://bse-atypical.blogspot.com/2011/05/study-of-atypical-bse-2010-annual.html

Saturday, March 5, 2011

MAD COW ATYPICAL CJD PRION TSE CASES WITH CLASSIFICATIONS PENDING ON THE RISE IN NORTH AMERICA

http://transmissiblespongiformencephalopathy.blogspot.com/2011/03/mad-cow-atypical-cjd-prion-tse-cases.html

TSS

Multidrug-Resistant Staphylococcus aureus in US Meat and Poultry

2011-04-18T15:03:00.000-07:00

Multidrug-Resistant Staphylococcus aureus in US Meat and Poultry

Andrew E. Waters,1 Tania Contente-Cuomo,1 Jordan Buchhagen,1 Cindy

M. Liu,1,2 Lindsey Watson,1 Kimberly Pearce,1 Jeffrey T. Foster,2

Jolene Bowers,1 Elizabeth M. Driebe,1 David M. Engelthaler,1 Paul

S. Keim,1,2 and Lance B. Price1

1Division of Pathogen Genomics, Translational Genomics Research Institute, and

2Center for Microbial Genetics and Genomics, Northern Arizona University,

Flagstaff, Arizona

We characterized the prevalence, antibiotic susceptibility profiles, and genotypes of Staphylococcus aureus among US meat and poultry samples (n 5 136). S. aureus contaminated 47% of samples, and multidrug resistance was common among isolates (52%). S. aureus genotypes and resistance profiles differed significantly among sample types, suggesting food animal–specific contamination.

Antimicrobials are used extensively in food animal production, where they are often applied subtherapeutically for growth promotion and routine disease prevention [1]. Surveys conducted by the National Antimicrobial Resistance Monitoring System (NARMS) indicate that retail meat and poultry products are frequently contaminated with multidrug-resistant Campylobacter species, Salmonella species, Enterococcus species, and Escherichia coli [2]; but little is known about the prevalence of other antibiotic-resistant pathogens in the US food supply. Staphylococcus aureus is among the most prevalent causes of clinical infections globally and has garnered substantial public attention due to increasing mortality associated with multidrug resistance. A new multidrug-resistant S. aureus strain, ST398, has emerged that predominantly colonizes people working in food animal production. First discovered in 2003, ST398 now makes up a substantial proportion of the community-acquired methicillin-resistant S. aureus (MRSA) cases in the Netherlands [3]. Multiple studies have demonstrated the high prevalence of multidrug-resistant S. aureus, including ST398, among intensively raised swine in the European Union, Canada, and the United States [4, 5], but few studies have been conducted to measure its prevalence in US food products [6]. In the current study, we evaluated the prevalence and antibiotic susceptibility profiles of S. aureus in retail meat and poultry samples from 5 US cities. We found that S. aureus contamination was common among the samples and that distinct S. aureus populations were associated with each meat and poultry type. We further demonstrated the prevalence of multidrug resistance, including resistance to clinically important antibiotics such as ciprofloxacin, quinupristin/dalfopristin, clindamycin, erythromycin, oxacillin, and daptomycin.

snip...

Our data demonstrate that retail meat and poultry are frequently contaminated with multidrug-resistant S. aureus, but the public health relevance of this finding is unclear. European and North American studies indicate that ST398 can successfully colonize and infect humans [4, 10], but few studies have investigated the risk of human colonization and infection with S. aureus from meat and poultry products [11, 12]. The European Food Safety Authority (EFSA) concluded that the risk for MRSA infection from food handling and consumption was low; however, this was based on a small number of studies [11]. Furthermore, EFSA did not evaluate the risk from methicillinsusceptible multidrug-resistant S. aureus, which is more common than MRSA among food samples.

Conventional concentrated animal feeding operations (CAFOs) provide all the necessary components for the emergence and proliferation of multidrug-resistant zoonotic pathogens. In the United States, billions of food animals are raised in densely stocked CAFOs, where antibiotics are routinely administered in feed and water for extended periods to healthy animals [1]. NARMS has shown that multidrug-resistant E. coli and Enterococcus species are prevalent among US meat and poultry products [2]. Our findings indicate that multidrug-resistant S. aureus should be added to the list of antimicrobial-resistant pathogens that routinely contaminate our food supply.

http://cid.oxfordjournals.org/content/early/2011/04/14/cid.cir181.full.pdf+html

Study Title: Multidrug-Resistant Staphylococcus aureus in US Meat and Poultry Study

Abstract: We characterized the prevalence, antibiotic susceptibility profiles, and genotypes of Staphylococcus aureus among US meat and poultry samples (n = 136). S. aureus contaminated 47% of samples, and multidrug resistance was common among isolates (52%). S. aureus genotypes and resistance profiles differed significantly among sample types, suggesting food animal–specific contamination.

From press release:

Drug-resistant strains of Staphylococcus aureus, a bacteria linked to a wide range of human diseases, are present in meat and poultry from U.S. grocery stores at unexpectedly high rates, according to a nationwide study by the Translational Genomics Research Institute (TGen).

Nearly half of the meat and poultry samples—47 percent—were contaminated with S. aureus, and more than half of those bacteria—52 percent—were resistant to at least three classes of antibiotics, according to the study published April 15 in the journal Clinical Infectious Diseases.

This is the first national assessment of antibiotic resistant S. aureus in the U.S. food supply. And, DNA testing suggests that the food animals themselves were the major source of contamination.

Although Staph should be killed with proper cooking, it may still pose a risk to consumers through improper food handling and cross-contamination in the kitchen.

Researchers collected and analyzed 136 samples—covering 80 brands—of beef, chicken, pork and turkey from 26 retail grocery stores in five U.S. cities: Los Angeles, Chicago, Fort Lauderdale, Flagstaff and Washington, D.C.

“For the first time, we know how much of our meat and poultry is contaminated with antibiotic-resistant Staph, and it is substantial,” said Lance B. Price, Ph.D., senior author of the study and Director of TGen’s Center for Food Microbiology and Environmental Health.

“The fact that drug-resistant S. aureus was so prevalent, and likely came from the food animals themselves, is troubling, and demands attention to how antibiotics are used in food-animal production today,” Dr. Price said.

Densely-stocked industrial farms, where food animals are steadily fed low doses of antibiotics, are ideal breeding grounds for drug-resistant bacteria that move from animals to humans, the report says.

“Antibiotics are the most important drugs that we have to treat Staph infections; but when Staph are resistant to three, four, five or even nine different antibiotics—like we saw in this study—that leaves physicians few options,” Dr. Price said.

“The emergence of antibiotic-resistant bacteria—including Staph—remains a major challenge in clinical medicine,” said Paul S. Keim, Ph.D., Director of TGen’s Pathogen Genomics Division and Director of the Center for Microbial Genetics and Genomics at Northern Arizona University (NAU).

“This study shows that much of our meat and poultry is contaminated with multidrug-resistant Staph. Now we need to determine what this means in terms of risk to the consumer,” said Dr. Keim, a co-author of the paper.

The U.S. government routinely surveys retail meat and poultry for four types of drug-resistant bacteria, but S. aureus is not among them. The paper suggests that a more comprehensive inspection program is needed.

S. aureus can cause a range of illnesses from minor skin infections to life-threatening diseases, such as pneumonia, endocarditis and sepsis.

The study was supported through a grant from The Pew Charitable Trusts as part of The Pew Campaign on Human Health and Industrial Farming.

Study Information: Andrew E. Waters, Tania Contente-Cuomo, Jordan Buchhagen, Cindy M. Liu, Lindsey Watson, Kimberly Pearce, Jeffrey T. Foster, Jolene Bowers, Elizabeth M. Driebe, David M. Engelthaler, Paul S. Keim, and Lance B. Price. Multidrug-Resistant Staphylococcus aureus in US Meat and Poultry Clinical Infectious Diseases 2011 April Center for Microbial Genetics and Genomics, Northern Arizona University, Flagstaff, Arizona.

Full Study: http://cid.oxfordjournals.org/content/early/2011/04/14/cid.cir181.full.pdf+html

ALSO, see ;

Thursday, August 12, 2010

Escherichia coli sequence type ST131 as the major cause of serious multidrug-resistant E. coli infections in the United States

Clin Infect Dis. 2010 Aug 1;51(3):286-94.

http://staphmrsa.blogspot.com/2010/08/escherichia-coli-sequence-type-st131-as.html

Staphylococcus toxin is not markedly affected by heating or freezing as it is heat stable. Even if the food is heated before eating, the poison in the food will cause illness although the heat has killed the bacterial cells.

http://www.foodscience.caes.uga.edu/extension/documents/FoodPoisoning-FoodInfection.pdf

Do all toxins in food survive the cooking process?

No, all toxins in food do not survive the cooking process. In fact, the botulism toxin caused by Clostridium botulinum can be inactivated by cooking. Boiling food for 10 minutes eliminates this toxin. However, many other toxins are heat stable. For example, Staphylococcus can produce toxins that are not destroyed by high cooking temperatures. To prevent toxins from developing in food, don"t leave food sitting out at room temperature for more than 2 hours. On a hot day (90° F or higher), food should not sit out for more than 1 hour.

http://www.gchd.org/NFSEM/a2z-t.html

The toxin produced by staph bacteria is very heat-stable – so it is not easily destroyed by heat at normal cooking temperatures. The bacteria may be killed, but the toxin remains. Careful handling of food that is prepared ahead of serving is important. This is especially important with foods left over after one meal and planned to be used again at a later meal. Quick cooling and refrigeration, or holding at or above 140ºF, can help ensure that toxin has no chance to be formed.

http://www.summitcountyhealth.org/food-service/foodborne-illness/staph-infection/

The toxin produced by staph bacteria is very heat-stable - it is not easily destroyed by heat at normal cooking temperatures. The bacteria themselves may be killed, but the toxin remains. Careful handling of food that is prepared ahead is important. This is especially important of foods left over after one meal and planned to be used again at a later meal. Quick cooling and refrigeration, or holding at or above 140 degrees F, can help ensure that toxin has no chance to be formed.

http://ohioline.osu.edu/hyg-fact/5000/5564.html

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

http://staphmrsa.blogspot.com/2010/04/fsis-national-residue-program-for.html

Thursday, February 11, 2010

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

http://staphmrsa.blogspot.com/2010/02/denmarks-case-for-antibiotic-free.html

also see ;

http://staphmrsa.blogspot.com/2008/03/iceid-2008-methicillin-resistant.html

http://staphmrsa.blogspot.com/

update 4/28/11

10 PATHOGEN-FOOD COMBINATIONS RANKING THE HEALTH RISK (TITLE TO RANCHERS)

Ranking the Risks: The 10 Pathogen-Food Combinations With The Greatest Burden on Public Health

Michael B. Batz, Sandra Hoffmann and J. Glenn Morris, Jr.

http://www.epi.ufl.edu/sites/www.epi.ufl.edu/files/RankingTheRisksREPORT.pdf

if this is what feeding the masses has come to, count me out ;

http://www.bloggernews.net/126457

update 4/21/11

Cache Creek Dairy 4/6/11

Department of Health and Human Services Public Health Service Food and Drug Administration San Francisco District Pacific Region 1431 Harbor Bay Parkway Alameda, CA 94502-7070 Telephone: 510-337-6700 FAX: 510-337-6701

UNITED PARCEL SERVICE DELIVERY SIGNATURE REQUESTED

Our Reference: 3006172673

WARNING LETTER

April 6, 2011

Mr. Jack Kasbergen, Co-Owner Mrs. Ellie M. Kasbergen, Co-Owner Cache Creek Dairy 31503 County Road 26 Woodland, California 95695

Dear Mr. & Mrs. Kasbergen:

On February 1, 2, and 10, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 31503 County Road 26, Woodland, California. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov1.

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 FD&C 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 FD&C Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the FD&C 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 May 27, 2010, you sold a dairy cow, identified with ear tag (b)(4) , for slaughter as food. On or about May 28, 2010, (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 at 0.431 parts per million (ppm) in the liver tissue. FDA has established a tolerance of 0.1 ppm for residues of sulfadimethoxine in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.640 (21 C.F.R. 556.640). 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 FD&C 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 FD&C Act, 21 U.S.C. § 342(a)(4).

We also found that you adulterated the new animal drugs sulfadimethoxine (b)(4) and flunixin meglumine (b)(4). Specifically, our investigation revealed that you did not use sulfadimethoxine and flunixin meglumine 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 FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C 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 one of your dairy cows identified with ear tag (b)(4) without following the dose and route of administration as stated in the approved labeling. Sulfadimethoxine is prohibited for extralabel use in lactating dairy cattle by 21 C.F.R. 530.41(a)(9) and your extralabel use of sulfadimethoxine resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Our investigation also found that you administered flunixin to one of your dairy cows identified with ear tag [b4] without following the route of administration as stated in its approved labeling. Your extralabel use of flunixin was not under the supervision of a licensed veterinarian in violation of 21 C.F.R. 530.11(a). Because your use 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 FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C 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 Karen L. Robles, Compliance Officer, Food and Drug Administration, at 650 Capitol Mall Room 8-400, Sacramento, California 95814. If you have any questions about this letter, please contact Compliance Officer Karen L. Robles at (916) 930-3674 extension 114 or via e-mail at Karen.Robles@fda.hhs.gov.

Sincerely,

/s/

Barbara J. Cassens District Director San Francisco District U. S. Food and Drug Administration

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm250770.htm

March 28, 2011

WARNING LETTER

CERTIFIED MAIL RETURN RECEIPT REQUESTED Refer to MIN 11 - 18

James B. Drake President and Co-owner Drake Dairy, Inc. N8870 Drake Court Elkhart Lake, Wisconsin 53020

Dear Mr. Drake:

On January 25 and February 14, 2011, the Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at N8870 Drake Court, Elkhart Lake, Wisconsin. This letter notifies you of 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 September 17, 2010, you consigned (b)(4) to haul your dairy cow (ear tag# (b)(4) indentified with back tag # (b)(4) for slaughter as food. On or about September 17, 2010, (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 ampicillin at 0.33 parts per million (ppm) in kidney. The FDA has established a tolerance of 0.01 ppm for ampicillin in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations, section 556.40, 21 CFR 556.40. 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 have an effective system to control administration of drug treatments to your animals. Herdsmen have been authorized to administer drugs; but they failed to relay treatment information to the herd manager. You also failed to maintain complete treatment records that include the drug, dosage, route of administration, and withholding period to ensure that treated cattle are not culled before labeled meat and milk withhold times are met. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4).

In addition to the above violation, we are concerned that USDA/FSIS identified another recent tissue residue associated with your dairy operation. Illegal levels of ampicillin and flunixin were found on October 20, 2009, in your dairy cow with ear tag #(b)(4) (back tag (b)(4).

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.

We received an unsigned letter dated October 26, 2010, from Drake Dairy. The letter was post-marked February 17, 2011, and received in our office on February 22, 2011. The letter states that you have taken steps to help ensure that drug residue violations will not happen in the future. You made changes in your treatment protocols and record keeping, established a new communication system between the Herdsman and the Herd Manager, and are now entering all treatments into the (b)(4) computer system. We consider these to be necessary and appropriate corrective actions. However, your letter did not provide documentation that corrections have been implemented. Within 15 working days of receiving this letter, please provide our office with further documentation to substantiate your corrections. For example, provide copies of a representative sample of treatment records and any other records demonstrating that corrections have been made.

Your written response should be sent to Timothy G. Philips, Compliance Officer, Food and Drug Administration, at the address located on the letterhead. If you have any questions about this letter, please contact Mr. Philips at (612) 758-7133.

Sincerely, /S/ Gerald J. Berg Director Minneapolis District

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm249410.htm

Van Es Dairy 3/25/11

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 25, 2011

CERTIFIED MAIL RETURN RECEIPT REQUESTED

In reply refer to Warning Letter SEA 11-08

Dale Van Es, Owner Van Es Dairy 8222 Desert Drive Marsing, Idaho 83639-8264

WARNING LETTER

Dear Mr. Van Es:

On December 8 and 9, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 8222 Desert Drive, Marsing, Idaho. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov1.

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 FD&C 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 FD&C Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the FD&C 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 16, 2010, you sold a dairy cow, identified with back tag (b)(4) and ear tag (b)(4), for slaughter as food. On or about June 18, 2010, (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 in the liver tissue at 0.662 parts per million (ppm). FDA has established a tolerance of 0.125 ppm for residues of flunixin in the liver of cattle as codified in Title 21, Code of Federal Regulations, Section 556.286 (21 C.F.R. 556.286). 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 FD&C 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 FD&C Act, 21 U.S.C. § 342(a)(4).

We also found that you adulterated sulfadimethoxine and flunixin meglumine. Specifically, our investigation revealed that you did not use Albon (sulfadimethoxine) Boluses, NADA 031-715, and Prevail (flunixin meglumine) Injectable, ANADA 200-308, 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 FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C 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 Albon (sulfadimethoxine) Boluses, NADA 031-715, to your dairy cows without following the dose as indicated in its approved labeling. Albon (sulfadimethoxine) Boluses, NADA 031-715, is prohibited from extralabel use in lactating dairy cattle by 21 C.F.R. 530.41(a)(9). Because your extralabel 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 FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5).

In addition, our investigation found that you administered Prevail (flunixin meglumine) Injectable, ANADA 200-308, to your dairy cows without following the dose and duration of treatment as indicated in its approved labeling. Your extralabel use of Prevail (flunixin meglumine) Injectable, ANADA 200-308, was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Because your extralabel 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 FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C 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 Lisa M. Althar, Compliance Officer, U.S. Food and Drug Administration, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have any questions about this letter, please contact Compliance Officer Lisa M. Althar at (425) 483-4940.

Sincerely,

/s/

Charles M. Breen District Director

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm249856.htm

Zimmerman, Mark S. 3/22/11

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 11-PHI-08

CERTIFIED MAIL RETURN RECEIPT REQUESTED

March 22, 2011

Mark S. Zimmerman, Owner Mark S. Zimmerman Farm 641 Cranberry Road Martinsburg, Pennsylvania 16662

Dear Mr. Zimmerman:

On January 25, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm operation located at 641 Cranberry Road, Martinsburg, Pennsylvania. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov1.

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 FD&C 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 FD&C Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the FD&C 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 March 1, 2010, you sold a bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about March 2, 2010, (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 in the liver at 0.121 parts per million (ppm). FDA has not established a tolerance for residues of flunixin in the edible tissues of veal calves. 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 FD&C 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 FD&C Act, 21 U.S.C. § 342(a)(4).

We also found that you adulterated the new animal drug Flunazine (flunixin meglumine). Specifically, our investigation revealed that you did not use Flunazine (flunixin meglumine) 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 FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C 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 new animal drug Flunazine (flunixin meglumine) to a bob veal calf, with back tag (b)(4), without following the animal class as stated in the approved labeling. Your extralabel use of the new animal drug Flunazine (flunixin meglumine) was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and resulted in an illegal 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 FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C 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.

We acknowledge that you have started keeping medical treatment records for your animals. However, we do not have enough information to allow FDA to evaluate whether the referenced corrective actions are adequate.

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 Robin Rivers, Compliance Officer, U.S. Food and Drug Administration, 900 U.S. Customhouse, 200 Chestnut Street, Philadelphia, Pennsylvania 19106. If you have any questions about this letter, please contact Ms. Rivers at (215) 717-3076 or E-mail at robin.rivers@fda.hhs.gov.

Sincerely,

/s/

Kirk D. Sooter District Director Philadelphia District

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm248149.htm

Horizon Acres 3/18/11

Department of Health and Human Services Public Health Service Food and Drug Administration Cincinnati District Office Central Region 6751 Steger Drive Cincinnati, OH 45237-30977 Telephone: (513) 679-2700 FAX: (513) 679-2761

WARNING LETTER CIN-11-65585-06

March 18, 2011

United Parcel Service

Mr. Kenneth D. Weaver, General Manager Horizon Acres 6728 Zuercher Road Dalton, Ohio 44618

Dear Mr. Weaver:

On November 10, 12, 19,24, 2010, and December 20, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your veal calf operation located at 6728 Zuercher Road, Dalton, Ohio 44618. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA's web page at www.fda.gov1.

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 FD&C 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 FD&C Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the FD&C 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 22, 2010, you sold an unidentified, untagged veal calf for slaughter as food. On or about June 22, 2010, (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 0.28 parts per million (ppm) of flunixin in the liver tissue. FDA has established a tolerance of 0.125 ppm for residues of flunixin in the liver of cattle as codified in 21 C.F.R. 556.286(b)(1)(i). However, this tolerance does not apply to use of Suppressor (flunixin meglumine) Injectable Solution, ANADA 200-308, in veal calves (pre-ruminating calves), and there is no acceptable level of residue associated with use of flunixin meglumine in veal calves (pre-ruminating calves). 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 FD&C 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 segregate treated animals. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4).

We also found that you adulterated the new animal drugs Suppressor (flunixin meglumine) ANADA 200-308, Dexamethasone ANADA 200-312, Ceftiflex sterile powder (ceftiofur sodium) ANADA 200-420, PennOne Pro (penicillin G procaine) NADA 65-010, Amoxicillin capsules NDC 65862-017-05, Sulfamethoxazole and Trimethoprim Double Strength tablets NDC 53746-272-05 (SMZ-TMP tablets), and Pennchlor 64 (chlortetracycline HCI) ANADA 200-295. Specifically, our investigation revealed that you did not use these drugs 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 FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C 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 flunixin meglumine to veal calves without following the withdrawal period as stated in the approved labeling. Your extralabel use of flunixin meglumine was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11(a) and your extralabel use of flunixin meglumine resulted in an illegal drug residue, in violation of 21 C.F.R. § 530.11(c).

Our investigation found that you administered dexamethasone to veal calves without following the route of administration and the withdrawal period as stated in the approved labeling. Your extralabel use of Dexamethasone was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11 (a).

Our investigation found that you administered ceftiofur sodium to veal calves without following the withdrawal period as stated in the approved labeling. Your extralabel use of ceftiofur sodium was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11(a).

Our investigation found that you administered penicillin G procaine to veal calves without following the route of administration and the withdrawal period as stated in the 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).

Our investigation found that you administered amoxicillin and sulfamethoxazole and trimethoprim (SMZ-TMP) to veal calves without following the route of administration and duration of the treatment as stated in their approved labeling. Your extralabel use of Amoxicillin and SMZ-TMP were not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11 (a) and your use of amoxicillin and SMZ-TMP in or on feed, is in violation of 21 C.F.R. § 530.11(b).

Our investigation found that you administered chlortetracycline HCI to veal calves without following the duration of treatment. Your use of chlortetracycline HCI was not under the supervision of a licensed veterinarian, and is in violation of 21 C.F.R. § 530.11(a) and your use of pennchlor 64 in or on feed, is in violation of 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. Part 530, you caused the drug(s) to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5).

In addition, you adulterated the liquid animal feed within the meaning of section 501(a)(6) of the FD&C Act, 21 U.S.C. § 351(a)(6), when you added sulfamethoxazole and trimethoprim, Amoxicillin, and chlortetracycline HCI, and you failed to use the medicated feed in conformance with its approved labeling. Your use of this medicated feed without following the animal class as directed by the approved labeling caused this medicated feed to be unsafe under section 512(a)(2) of the FD&C Act, 21 U.S.C. § 360b(a)(2), and adulterated under section 501(a)(6) of the FD&C Act, 21 U.S.C. § 351(a)(6). Section 512 of the FD&C Act, 21 U.S.C. § 360b, and 21 C.F.R. 530.11(b) do not permit the extralabel use of medicated feed.

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 Allison C. Hunter, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions about this letter, please contact Compliance Officer Hunter at 513-679-2700 ext. 134.

Sincerely yours, /S/

Teresa Thompson District Director Cincinnati District

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm248212.htm

Azevedo and Sons Dairy, Inc. 3/4/11

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 4, 2011

CERTIFIED MAIL RETURN RECEIPT REQUESTED

In reply refer to Warning Letter SEA 11-06

Lisuarte M. Azevedo, President Azevedo and Sons Dairy, Inc. 10034 Hendricks Road Othello, Washington 99344

WARNING LETTER

Dear Mr. Azevedo:

On January 5 and 13, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 10034 Hendricks Road, Othello, Washington. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov. 1

We found that you offered for sale animals for slaughter as food that were adulterated. Under section 402(a)(2)(C)(ii) of the FD&C 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 FD&C Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the FD&C 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 23, 2010, you sold a cow, identified with ear tag number (b)(4) for slaughter as food. On or about July 23, 2010, (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 0.801 parts per million (ppm) flunixin in the liver tissue. FDA has established a tolerance of 0.125 ppm for residues of flunixin in the edible tissues of cows as codified in Title 21, Code of Federal Regulations, Section 556.286 (21 C.F.R. § 556.286). In addition, our investigation revealed that on or before May 6, 2010, you delivered a cow identified with ear tag number (b)(4) to (b)(4). On or about May 6, 2010, (b)(4), slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of 0.755 ppm sulfadimethoxine in liver tissue. FDA has established a tolerance of 0.1 ppm for residues of sulfadimethoxine in the edible tissues of cows as codified in 21 C.F.R. § 556.640. The presence of these drugs in edible tissue from these animal in these amounts causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C 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 FD&C Act, 21 U.S.C. § 342(a)(4).

We also found that you adulterated the new animal drugs Banamine NADA # 101-479 (flunixin meglumine) and Albon NADA # 031-715 (sulfadimethoxine). Specifically, our investigation revealed that you did not use flunixin meglumine and sulfadimethoxine as directed by their approved labeling. Use of these drugs in this manner is an extralabel use as indicated in 21 C.F.R. § 530.3(a).

The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C 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 flunixin meglumine to the cow identified with ear tag number (b)(4) without following the dose, route of administration, and withdrawal period as stated in the approved labeling. Your extralabel use of flunixin meglumine was not under the supervision of a license veterinarian, in violation of 21 C.F.R. § 530.11(a) and your extralabel use of flunixin meglumine resulted in illegal drug residues, in violation of 21 C.F.R. § 530.11(d). Our investigation also found that you administered sulfadimethoxine (Albon) to the cow identified with ear tag number (b)(4) without following the dose and withdrawal period as stated in the approved labeling. Sulfadimethoxine is prohibited for extralabel use in lactating dairy cattle by 21 C.F.R. § 530.41(a)(9) and your extralabel use of sulfadimethoxine resulted in an illegal drug residue, in violation of 21 C.F.R. § 530.11(d). Because your use of these drugs were 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 FD&C Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C 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.

Our investigation also revealed that on or about May 4, 2010, and on or about August 17, 2010, you provided to (b)(4), a signed certification, that states that all animals brought to (b)(4), for sale or processing, have been handled in a manner to prevent pharmaceutical or biological residue violation. On or about July 23, 2010, you delivered a cow containing violative flunixin residue to (b)(4). Providing such a false guaranty is prohibited by section 301(h) of the FD&C Act, 21 U.S.C. 331(h). You should take appropriate actions to ensure that this violation does not recur. 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 Patricia A. Pinkerton, Compliance Officer, U.S. Food and Drug Administration, 22201 23rd Drive SE, Bothell, Washington 98021-4426. If you have any questions about this letter, please contact Compliance Officer Patricia Pinkerton at 425-483-4926.

Sincerely yours,

S/

Charles M. Breen District Director

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm247175.htm

Amting Dairy Farm 3/4/11

Department of Health and Human Services Public Health Service Food and Drug Administration Detroit District 300 River Place Suite 5900 Detroit, MI 48207 Telephone: 313-393-8100 FAX: 313-393-8139

WARNING LETTER 2011-DET-07

March 4, 2011

VIA UNITED PARCEL SERVICE

Mr. Bernardus H. Amting, Owner Amting Dairy Farm 17451 N Drive N Marshall, Michigan 49068

Dear Mr. Amting:

On December 16 and 29, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 17451 N Drive N, Marshall, Michigan. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov1.

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 FD&C 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 FD&C Act, 21 U.S.C. 360b. Further, under section 402(a)(4) of the FD&C 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 31, 2010, you sold a dairy cow, identified with back tag (b)(4) and ear tag (b)(4), for slaughter as food. On or about September 1, 2010, (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 sulfamethazine in the liver tissue at 0.268 parts per million (ppm). 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, Section 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 FD&C 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 FD&C Act, 21 U.S.C. 342(a)(4).

We also found that you adulterated the new animal drugs flunixin and oxytetracycline. Specifically, our investigation revealed that you did not use Suppressor (flunixin meglumine), ANADA 200-308, and Oxytet 100 (oxytetracycline hydrochloride), ANADA 200-452, as directed by their approved labeling. Use of these drugs in this manner is an extra label use, 21 C.F.R. 530.3(a).

The extra label use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extra label use complies with sections 512(a)(4) and (5) of the FD&C 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 flunixin to a dairy cow, identified with back tag (b)(4) and ear tag (b)(4), without following the route of administration and the withdrawal period as indicated in its approved labeling. Your extra label use of flunixin was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Because your extra label 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 FD&C Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5).

In addition, our investigation found that you administered oxytetracycline to a dairy cow, identified with back tag (b)(4) and ear tag (b)(4), without following the withdrawal period as indicated in its approved labeling. Your extra label use of oxytetracycline was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Because your extra label 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 FD&C Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C 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.

We remind you that FDA has issued you a prior Warning Letter on August 29, 2003. A copy of this Warning Letter is provided for your review and information.

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 Mr. Michael V. Owens, Compliance Officer, U.S. Food and Drug Administration at 300 River Place, Suite 5900 Detroit, Michigan 48207. If you have any questions about this letter, please contact Compliance Officer Michael Owens at 313-393-8167 or E-mail at michael.owens@fda.hhs.gov.

Sincerely yours,

/s/

Joann M. Givens District Director Detroit District Office

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm246193.htm

InSight Dairy, LLC. 2/24/11

Department of Health and Human Services Public Health Service Food and Drug Administration New York District

158-15 Liberty Avenue Jamaica, NY 11433

February 24, 2011

WARNING LETTER NYK-2011-18

VIA United Parcel Services

Christopher A. and Jessica A. Fredericks, Owners InSight Dairy, LLC. 682 Newville Road Little Falls, New York 13365-4614

Dear Mr. and Ms. Fredericks,

On January 4 and 6, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 682 Newville Road, Little Falls, New York 13365-4614. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C 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.gov1.

We found that you offered for sale animals for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the FD&C 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 FD&C Act, 21 U.S.C. 360b. Further, under section 402(a)(4) of the FD&C 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 19, 2010, you sold a bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about July 20, 2010, (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 12.95 parts per million (ppm) of neomycin residue in the kidney. In addition, our investigation revealed that on or about August 2, 2010, you sold a bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about August 3, 2010, (b)(4), slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of 10.53 parts per million (ppm) of neomycin residue in the kidney. FDA has established a tolerance of 7.2 ppm for residues of neomycin in the kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.430 (21 C.F.R. 556.430). However, this tolerance does not apply to the use of (b)(4) in bob veal calves, and there is no acceptable level of residue associated with the use of this medicated milk replacer in veal calves. 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 FD&C 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 FD&C Act, 21 U.S.C. 342(a)(4).

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

Our investigation found that you fed (b)(4) containing neomycin sulfate to both bob veal calves with back tags #(b)(4) without following the approved labeling. The extralabel use of (b)(4)containing neomycin sulfate was in or on feed, in violation of 21 C.F.R. 530.11(b), and the extralabel use resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(c). Because this use of (b)(4) containing neomycin sulfate was not in conformance with the approved labeling, you caused the drug in the feed to be unsafe under section 512(a)(1) of the FD&C Act, 21 U.S.C. § 360b(a)(1), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5). In addition, you caused the animal feed containing the neomycin sulfate to be unsafe under section 512(a)(2) of the FD&C Act, 21 U.S.C. § 360b(a)(2), and adulterated within the meaning of section 501(a)(6) of the FD&C 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 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 Dean R. Rugnetta, Compliance Officer, U.S. Food and Drug Administration, 300 Pearl Street, Suite 100, Buffalo, New York 14202. If you have any questions about this letter, please contact Compliance Officer Dean R. Rugnetta at (716) 541-0324 or Email at Dean.Rugnetta@fda.hhs.gov.

Sincerely yours,

/S/ Ronald M. Pace District Director New York District

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm245257.htm

Jesse R. Petre Farm 2/15/11

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

WARNING LETTER 11-PHI-06

CERTIFIED MAIL RETURN RECEIPT REQUESTED

February 15, 2011

Mr. Jesse R. Petre Farm, Owner 1215 Mason Dixon Road Greencastle, PA 17225

Dear Mr. Petre:

On January 12, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm operation located at 1215 Mason Dixon Road, Greencastle, PA. 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.gov1.

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 January 14, 2010, you sold a veal calf, identified with back tag (b)(4) for slaughter as food. On or about January 15, 2010, (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 7.37 parts per million (ppm) of neomycin in the kidney tissue, and 0.11 ppm of flunixin in the liver tissue. FDA has established a tolerance of 7.2 ppm for neomycin, and 0.125 parts per billion (ppb) for flunixin in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), (21 C.F.R. 556.430(b)(1); 556.286(b)(1)). The presence of these drugs in edible tissues from this animal in these amounts cause 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).

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 Robin M. Rivers, Compliance Officer, United States Food and Drug Administration, United States Customs House, Room 900, 200 Chestnut Street, Philadelphia, PA 19106. If you have any questions about this letter, please contact Ms. Rivers at 215-717-3076.

Sincerely,

/s/

Kirk D. Sooter District Director Philadelphia District Office

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm244595.htm

Lloyd B. Zimmerman and Sons 2/15/11

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

WARNING LETTER 11-PHI-07

CERTIFIED MAIL RETURN RECEIPT REQUESTED

February 15, 2011

Mr. Lloyd B. Zimmerman, Owner Lloyd B. Zimmerman and Sons 2413 Snydertown Road Danville, Pennsylvania 17821-7429

Dear Mr. Zimmerman:

On October 28, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm operation located at 2413 Snydertown Road, Danville, PA. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov1.

We found that you offered for sale animals for slaughter as food that were adulterated. Under section 402(a)(2)(C)(ii) of the FD&C 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 FD&C Act, 21 U.S.C. 360b. Further, under section 402(a)(4) of the FD&C 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 May 5, 2010, you sold a bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about May 5, 2010, (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 in the kidney at 15.14 parts per million (ppm). FDA has established a tolerance of 7.2 ppm for residues of neomycin in the uncooked edible kidney tissue of cattle as codified in Title 21, Code of Federal Regulations, Section 556.430(b)(1) (21 C.F.R. 556.430(b)(1)). However, this tolerance does not apply to the use of (b)(4) Vigormilk 22BNT Medicated Milk Replacer containing oxytetracycline, and neomycin in veal calves (pre-ruminating calves), and there is no acceptable level of residue associated with the use of (b)(4) Vigormilk 22BNT Medicated Milk Replacer containing oxytetracycline, and neomycin in veal calves (pre-ruminating calves). Therefore, 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 FD&C Act, 21 U.S.C. 342(a)(2)(C)(ii).

In addition, our investigation revealed that on or about July 14, 2010, you sold a bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about July 14, 2010, (b)(4), slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of neomycin in the kidney at 11.51 ppm. FDA has established a tolerance of 7.2 ppm for residues of neomycin in the uncooked edible kidney tissue of cattle as codified in 21 C.F.R. 556.430(b)(1). However, this tolerance does not apply to the use of (b)(4) Vigormilk 22BNT Medicated Milk Replacer containing oxytetracycline, and neomycin in veal calves (pre-ruminating calves), and there is no acceptable level of residue associated with the use of (b)(4) Vigormilk 22BNT Medicated Milk Replacer containing Oxytetracycline, and neomycin in veal calves (pre-ruminating calves). Therefore, 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 FD&C 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 FD&C Act, 21 U.S.C. 342(a)(4).

We also found that you adulterated the new animal drugs oxytetracycline, and neomycin that were contained in the (b)(4) Vigormilk 22BNT Medicated Milk Replacer. Specifically, our investigation revealed that you did not use (b)(4) Vigormilk 22BNT Medicated Milk Replacer as directed by its 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 FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C 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 new animal drugs Oxytetracycline, and neomycin that were contained in the (b)(4) Vigormilk 22BNT Medicated Milk Replacer to your bob veal calves without following the animal class as stated in the approved labeling. Your extralabel use of the new animal drugs oxytetracycline, and neomycin that were contained in the (b)(4) Vigormilk 22BNT Medicated Milk Replacer was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and resulted in an illegal residue, in violation of 21 C.F.R. 530.11(c). Because your use of these drugs in the (b)(4) Vigormilk 22BNT Medicated Milk Replacer was not in conformance with its 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 FD&C Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C 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.

We are aware that you sold two bob veal calves on or about October 6, 2010, that contained 10.2 ppm of neomycin in the kidney tissue of one bob veal calf, identified with back tag (b)(4), and the presence of gentamicin in the kidney tissue of one bob veal calf, identified with back tag (b)(4). FDA has established a tolerance of 7.2 ppm for residues of neomycin in the uncooked edible kidney tissue of cattle as codified in 21 C.F.R. 556.430(b)(1). FDA has not established a tolerance for gentamicin in the edible tissues of cattle.

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 Robin Rivers, Compliance Officer, U.S. Food and Drug Administration, 900 U.S. Customhouse, 200 Chestnut Street, Philadelphia, Pennsylvania 19106. If you have any questions about this letter, please contact Ms. Rivers at (215) 717-3076 or E-mail at robin.rivers@fda.hhs.gov.

Sincerely,

/s/

Kirk D. Sooter District Director Philadelphia District

- http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm244555.htm

Hite's Livestock, Inc. 2/1/11

Department of Health and Human Services Public Health Service Food and Drug Administration Baltimore District Office 6000 Metro Drive, Suite 101 Baltimore, MD 21215 Telephone: (410) 779-5455 FAX: (410) 779-5707

WARNING LETTER CMS #151635

February 1, 2011

CERTIFIED MAIL RETURN RECEIPT REQUESTED

Mr. David A. Hite, Owner Hite’s Livestock, Inc. HC 34 Box 8 Bloomery, West Virginia 26817-9703

Dear Mr. Hite:

On November 29 and December 3, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your livestock operation located at HC 34 Box 8, Bloomery, West Virginia 26817-9703. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov1.

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 FD&C 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 FD&C Act, 21 U.S.C. 360b. Further, under section 402(a)(4) of the FD&C 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 22, 2010, you sold an unidentified goat for slaughter as food. On or about August 24, 2010, (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 moxidectin at 0.0383 parts per million (ppm) in the liver tissue and 0.0543 ppm in the muscle tissue. FDA has not established a tolerance for residues of moxidectin in the edible tissues of goats. 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 FD&C 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 lack a system to ensure that animals you buy and then sell for slaughter as food have not been medicated or, if they have been medicated, to allow you to withhold the animals from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissues. In addition, you fail to keep accurate records of animals you buy and sell to ensure that the animals can be traced back to the producer or other dealer. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. 342(a)(4).

The violations listed above are not intended to be an all-inclusive list. It is your responsibility to assure that your operations are in compliance with the law. As a dealer of animals, you are frequently the individual who introduces or offers for introduction into interstate commerce, the adulterated animals. As such, you share responsibility for violating the Federal Food, Drug and Cosmetic Act. To avoid future illegal residue violations you should take precautions such as:

1. Implementing a system to identify the animals you purchase with records to establish traceability to the source of the animal; and

2. Implementing a system to determine from the source of the animal whether the animal has been medicated and with what drug(s); and

3. If the animal has been medicated, implementing a system to withhold the animal from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissue. If you do not want to hold the medicated animal then it should not be offered for human food, and it should be clearly identified and sold as a medicated animal.

You should take prompt action to correct the 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 Ms. Cherlita Honeycutt, Compliance Officer, U.S. Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215. If you have any questions about this letter, please contact Compliance Officer Cherlita Honeycutt at (410) 779-5412 or via e-mail at Cherlita.Honeycut@fda.hhs.gov.

Sincerely yours,

/s/

Evelyn Bonnin District Director Baltimore District

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm242828.htm

Vander Schaaf Dairy #2 1/10/11

Department of Health and Human Services Public Health Service Food and Drug Administration San Francisco District Pacific Region 1431 Harbor Bay Parkway Alameda, CA 94502-7070 Telephone: 510-337-6700 FAX: 510-337-6701

UNITED PARCEL SERVICE DELIVERY SIGNATURE REQUESTED

Our Reference: 1000307183

WARNING LETTER

January 10, 2011

Mr. Earl John Vander Schaaf, Owner Vander Schaaf Dairy #2 15355 Van Allen Road Escalon, California 95320

Dear Mr. Vander Schaaf:

On September 22 and 27, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 15355 Van Allen Road, Escalon, California 95320. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov1.

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 FD&C 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 FD&C Act, 21 U.S.C. 360b. Further, under section 402(a)(4) of the FD&C 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 April 9, 2010, you sold a dairy cow, identified with ear tag (b)(4), for slaughter as food. On or about April 10, 2010, (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 at 7.068 parts per million (ppm) in the liver tissue. FDA has established a tolerance of 0.1 ppm for residues of sulfadimethoxine in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.640 (21 C.F.R. 556.640). 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 FD&C 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 FD&C Act, 21 U.S.C. 342(a)(4).

We also found that you adulterated the new animal drugs sulfadimethoxine (b)(4) , sulfadimethoxine (b)(4), Penicillin G Procaine (b)(4) , and Ceftiofur (b)(4). Specifically, our investigation revealed that you did not use sulfadimethoxine, penicillin G procaine, and ceftiofur as directed by its approved labeling. Use of these drugs in this manner is an extralabel use. See 21 C.F.R. 530.3(a). In addition, the extralabel use of sulfadimethoxine is prohibited in lactating dairy cows under 21 C.F.R. 530.41(a)(9).

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 FD&C 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 (b)(4) to one of your dairy cows identified with ear tag (b)(4) without following the dose and withdrawal period as stated in the approved labeling. Sulfadimethoxine is prohibited for extralabel use in lactating dairy cows by 21 C.F.R. 530.41(a)(9). Furthermore, your extralabel use of sulfadimethoxine 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 FD&C Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5).

Our investigation also found that you administer sulfadimethoxine (b)(4) to your dairy cows intravenously or subcutaneously whereas the label directions indicate the drug is to be administered intravenously only. Your extralabel use of sulfadimethoxine (b)(4) was not under the supervision of a licensed veterinarian in violation of 21 C.F.R. 530.11(a). Sulfadimethoxine is prohibited for extra label use in lactating dairy cattle within 21 C.F.R. 530.41(a)(9). 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 FD&C Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5).

Our investigation also found that you administer penicillin G procaine injectable suspension (b)(4) to your dairy cows without following the dose as stated in the approved labeling. Your extralabel use of penicillin was not under the supervision of a licensed veterinarian which is in violation of 21 C.F.R. 530.11(a). 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 FD&C Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5).

Our investigation also found that you administer ceftiofur (b)(4) to your dairy cows without following the meat withdrawal period and conditions for treatment as stated in the approved labeling. Your extralabel use of ceftiofur was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). 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 FD&C Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C 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 Karen L. Robles, Compliance Officer, Food and Drug Administration, at 650 Capitol Mall Room 8-400, Sacramento, California 95814. If you have any questions about this letter, please contact Compliance Officer Karen L. Robles at (916) 930-3674 extension 114 or via e-mail at Karen.Robles@fda.hhs.gov.

Sincerely,

/s/

Barbara J. Cassens District Director San Francisco District U. S. Food and Drug Administration

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm239912.htm

see more here ;

http://google2.fda.gov/search?q=Animals+for+Sale+for+Slaughter+as+Food%2FAdulterated&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&output=xml_no_dtd&getfields=*&x=11&y=14

TSS

Escherichia coli sequence type ST131 as the major cause of serious multidrug-resistant E. coli infections in the United States

2010-08-12T18:51:00.000-07:00

Clin Infect Dis. 2010 Aug 1;51(3):286-94.

Escherichia coli sequence type ST131 as the major cause of serious multidrug-resistant E. coli infections in the United States.

Johnson JR, Johnston B, Clabots C, Kuskowski MA, Castanheira M.

Infectious Diseases,VA Medical Center, Minneapolis, MN 55417, USA. johns007@umn.edu

Comment on:

Clin Infect Dis. 2010 Aug 1;51(3):280-5.

Abstract

BACKGROUND: Escherichia coli sequence type ST131 (O25:H4), associated with the CTX-M-15 extended-spectrum beta-lactamase, has emerged internationally as a multidrug-resistant pathogen but has received little attention in the United States.

METHODS: From the SENTRY and Meropenem Yearly Susceptibility Test Information Collection (MYSTIC) surveillance programs, 127 E. coli clinical isolates from hospitalized patients across the United States in 2007, stratified by extended-spectrum cephalosporin and fluoroquinolone phenotype and bla(CTX-M-15) genotype, were assessed for phylogenetic group, ST131 status, susceptibility profile, virulence genotype, gyrA and parC sequence, and pulsed-field gel electrophoresis profile.

RESULTS: The 54 identified ST131 isolates (all fluoroquinolone resistant) accounted for an estimated 17% of the source populations, including 67%-69% of isolates resistant to extended-spectrum cephalosporins or fluoroquinolones, 55% of those resistant to both fluoroquinolones and trimethoprim-sulfamethoxazole, and 52% of multidrug-resistant isolates. Their distinctive virulence profiles were more extensive compared with other antimicrobial-resistant isolates but similarly extensive compared with antimicrobial-susceptible isolates. Pulsed-field profiling suggested ongoing dissemination among locales, with concentration of bla(CTX-M-15) within specific ST131 lineages. A historical ST131 isolate lacked the 2007 ST131 isolates' conserved fluoroquinolone resistance-associated single-nucleotide polymorphisms in gyrA and parC.

CONCLUSIONS: A single E. coli clonal group, ST131, probably caused the most significantly antimicrobial-resistant E. coli infections in the United States in 2007, thereby constituting an important new public health threat. Enhanced virulence and/or antimicrobial resistance compared with other E. coli, plus ongoing dissemination among locales, may underlie ST131's success. Urgent investigation of the sources and transmission pathways of ST131 is needed to inform mitigation efforts.

PMID: 20572763 [PubMed - in process]

http://www.ncbi.nlm.nih.gov/pubmed/20572763

NEWS RELEASE

For Release: Friday, July 30, 2010

Contact Information Contact Name: John Heys Contact E-mail: jheys@idsociety.org Contact Phone: 703-299-0412

Emerging E. coli Strain Causes Many Antimicrobial-Resistant Infections in U.S.

A new, drug-resistant strain of E. coli is causing serious disease, according to a new study, now available online, in the August 1, 2010 issue of Clinical Infectious Diseases.

The new strain, ST131, was a major cause of serious antimicrobial-resistant E. coli infections in the United States in 2007, researchers found. This strain has been reported in multiple countries and encountered all over the United States. In the study, researchers analyzed resistant E. coli isolates collected during 2007 from hospitalized patients across the country. They identified 54 ST131 isolates, which accounted for 67 percent to 69 percent of E. coli isolates exhibiting fluoroquinolone or extended-spectrum cephalosporin resistance.

“If we could discover the sources of this strain, the transmission pathways that allow it to spread so effectively, and the factors that have led to its rapid emergence, we could find ways to intervene and possibly slow or halt this strain’s emergence,” said study author James Johnson, MD, of the VA Medical Center in Minneapolis.

In the past, highly virulent E. coli strains usually have been susceptible to antibiotics, while highly resistant strains have been fairly weak in terms of their ability to cause disease. The susceptible strains were easily treated even though they caused serious infections, while the resistant ones tended mostly to affect only weakened or vulnerable individuals. Now, the study’s findings suggest, the ST131 strain has appeared with a high level of virulence and antimicrobial resistance.

“If this strain gains one additional resistance gene,” Dr. Johnson added, “it will become almost untreatable and will be a true superbug, which is a very concerning scenario.”

###

Founded in 1979, Clinical Infectious Diseases publishes clinical articles twice monthly in a variety of areas of infectious disease, and is one of the most highly regarded journals in this specialty. It is published under the auspices of the Infectious Diseases Society of America (IDSA). Based in Arlington, Va., IDSA is a professional society representing more than 9,000 physicians and scientists who specialize in infectious diseases. For more information, visit www.idsociety.org.

http://www.idsociety.org/Content.aspx?id=16864

http://staphmrsa.blogspot.com/

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

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

2010-04-14T19:15:00.000-07:00

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.

snip...

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

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.

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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.

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

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).

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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).

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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).

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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).

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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

Denmark's Case for Antibiotic-Free Animals

2010-02-11T10:19:00.000-08:00

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.

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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

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* 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

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

2009-12-01T07:57:00.000-08:00

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

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

2009-01-23T07:16:00.000-08:00

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/

WARNING LETTER An inspection of your licensed medicated feed mill, Cargill, Inc. 1000% higher than the levels indicated on the product's label. ...

2008-07-23T10:04:00.000-07:00

Public Health Service Food and Drug Administration

Seattle District Pacific Region 2201 23rd Drive SE Bothell, WA 98021-4421

Telephone: 425-486-8788 FAX: 425-483-4996

June 25, 2008

CERTIFIED MAIL RETURN RECEIPT REQUESTED

Gregory R. Page, President and CEO Cargill, Inc. 15407 McGinty Road West Wayzata, Minnesota 55391

In reply refer to Warning Letter SEA 08-22

WARNING LETTER

Dear Mr. Page:

An inspection of your licensed medicated feed mill, Cargill, Inc., located at 1406 Industrial Avenue, Billings, Montana, conducted by the U.S. Food and Drug Administration (FDA) on February 25, 26, and 27, 2008, found significant deviations from current Good Manufacturing Practice (cGMP) regulations for Medicated Feeds (Title 21, Code of Federal Regulations, Part 225 (21 C.F.R. 225)). These deviations cause feeds being manufactured at this facility to be adulterated within the meaning of section 501 (a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 351(a)(2)(B)]. In addition, your llama feed, Llama Mineral, was found to contain the new animal drug [redacted] (chlortetracycline), which is not approved for use in llama feed. The use of the new animal drug, Type A, medicated article [redacted] (chlortetracycline), contrary to its approved labeling causes the drug to be deemed unsafe within the meaning of section 512(a)(1) of the Act [21 U.S.C. § 360b(a)(1)] and adulterated with in the meaning of section 501 (a)(5) of the Act [21 U.S.C. § 351(a)(5)]. In addition, the llama feed containing [redacted] (chlortetracycline) is deemed to be unsafe within the meaning of section 512(a)(2) of the Act [21 U.S.C. § 360b(a)(2)] and adulterated within the meaning of section 501 (a)(6) of the Act [21 U.S.C. § 351(a)(6)].

We reviewed your firm's response, dated March 13, 2008, to the FDA-483. We found that the response lacks sufficient detail, explanation, documentation, or substantive corrective action plans to adequately address the deviations noted during the February 2008 inspection of your licensed medicated feed mill in Billings, Montana.

We acknowledge your firm has made some changes and corrections in response to Agency findings and requests. However, we have found that, while some individual cGMP deficiencies may have been corrected, your firm has failed to institute sufficient corrections for your firm's manufacturing processes to conform to the following cGMP requirements in 21 C.F.R. 225:

1. When results of laboratory assays of drug components indicated that medicated feeds were not within permissible assay limits, your facility did not implement investigations and corrective actions, as required by 21 C.F.R. 225.58(d). For example:

a. An assay of the cattle feed "NB TRANS PL 5LB [redacted]" manufactured on March 29, 2007, and submitted for sulfamethazine analysis on or about April 12, 2007, determined a sulfamethazine level 26% above the claimed potency. No investigation or corrective action was undertaken at that time.

b. An assay of the cattle feed "NB TRANS PL 10LB [redacted] manufactured on May 15, 2007, and submitted for sulfamethazine analysis on or about June 12, 2007, determined a sulfamethazine level 24.4% above the claimed potency. No investigation or corrective action was undertaken at that time.

We acknowledge your firm's response that the importance of performing an immediate investigation into the reason for an out-of-tolerance assay result and implementing corrective action has been reviewed with appropriate personnel to ensure compliance with regard to any future out-of-tolerance assays. We further acknowledge your firm's action of completing investigations into these two assays at the time of the February 2008 inspection. However, the results. of the assays were reported to your Billings, Montana feed mill seven to ten months prior to the February 2008 inspection. FDA does not consider an investigation occurring after a seven to ten month delay to be sufficient. Further, your response states that with respect to the February 2008 investigation, "no manufacturing errors were noted." However, FDA was informed by your firm at the time of inspection that the assay of the feed manufactured on March 29, 2007, failed because [redacted] mixer was not functioning properly. The malfunction of [redacted] mixer constitutes a manufacturing error.

2. When results of laboratory assays indicated that medicated feeds failed to meet the labeled drug potency, your facility did not take corrective actions that included discontinuing distribution of the feeds, as required by 21 C.F.R. 225.58(e). For example:

a. An assay of the cattle feed "NB TRANS PL 5LB [redacted]" manufactured on March 29, 2007, and submitted for sulfamethazine analysis on or about April 12, 2007, determined a sulfamethazine level 26% above the claimed potency. No investigation or corrective action was undertaken at that time, including discontinuing distribution of the affected feed products.

b. An assay of the cattle feed "NB TRANS PL 10LB [redacted]" manufactured on May 15, 2007, and submitted for sulfamethazine analysis on or about June 12, 2007, determined a sulfamethazine level 24.4% above the claimed potency. No corrective action was undertaken at that time, including discontinuing distribution of the affected feed products.

We acknowledge your firm's response that the importance of withholding such feed from distribution has been reviewed with appropriate personnel to ensure compliance with regard to any future out-of-tolerance assays. Your response also notes that there was no product available for recovery. This is understandable as the investigation into the assays that showed the feeds not to be in accord with permissible limits did not occur for seven to ten months after the assay results were reported. However, as discussed above, FDA does not consider corrective action taken seven to ten months after the reported assay results to be sufficient.

3. Laboratory analysis results demonstrate that the cleanout procedures established and used in the production of your facility's medicated feeds are not adequate to prevent unsafe contamination of feed, as required by 21 C.F.R. 225.65(b). For example:

a. Laboratory analysis by the Montana State Department of Agriculture found chlorotetracycline in Nutrena Naturewise Lamb and Sheep Feed, manufactured on February 4, 2008, at 550 grams per ton, which is 10 times higher than the level of 50 grams per ton indicated on the product's label. FDA analysis of a sample collected from a different portion of the same lot of lamb and sheep feed found levels of chlorotetracycline at 160 grams per ton (320 % of formula).

b. FDA analysis of a retain sample collected from a lot of medicated cattle feed manufactured at your facility, identified as "Nutrabeef Cattle Grower Feed," found levels of chlortetracycline at 4.8 parts per million (ppm). This product is formulated to contain no chlortetracycline.

c. FDA analysis of a retain sample collected from a lot of medicated cattle feed manufactured at your facility, identified as "Miller FDLT 45/27," found levels of chlortetracycline at 88.0 ppm. This product is formulated to contain no chlortetracycline.

d. FDA analysis of a retain sample collected from a lot of non-medicated llama feed manufactured at your facility, identified as "Llama Mineral," found levels of chlortetracycline at 96.0 ppm. This product is formulated to contain no chlortetracycline.

We acknowledge your firm's response that the incident described above regarding Nutrena Naturewise Lamb and Sheep Feed represents an isolated incident.

However, this response is inadequate in light of analytical sample results confirming cross contamination in several additional products (i.e., "Nutrabeef Cattle Grower Feed," "Miller FDLT 45/27," and "Llama Mineral"). As these analytical results indicate that this is not an isolated incident, FDA continues to have concerns regarding the adequacy of the cleanout procedures at your Billings, Montana facility.

4. Your facility does hot utilize proper sequential production of medicated feeds on a predetermined basis designed to prevent unsafe contamination of feeds with residual drugs in the manufacture of medicated and non-medicated feeds, as required by 21 C.F.R. 225.65(b)(3). For example:

a. On February 4, 2008, your facility produced a medicated feed, identified as "Nutrena Naturewise Lamb and Sheep Feed," which is formulated to contain relatively low levels (0.55 lbs per ton) of the Type A, medicated article [redacted] (chlortetracycline), following the production of a medicated feed, identified as "Nutrena CTC 10 Gram," which is formulated to contain relatively high levels (222 lbs per ton) of the Type A, medicated article [redacted]. This resulted in levels of chlortetracycline in the lamb and sheep feed up to 1000% higher than the levels indicated on the product's label.

b. On January 8, 2008, your facility produced a lot of non-medicated feed, identified as "Llama Mineral," which is formulated to contain no chlortetracycline, following the production of a medicated feed, identified as "Nutrena CTC 10 Gram," which is formulated to contain relatively high levels (222 lbs per ton) of the Type A, medicated article [redacted] (chlortetracycline). This resulted in cross contamination of the "Llam a Mineral" with levels of chlortetracycline at 96.0 ppm.

c. On November 19, 2007, your facility produced a lot of, medicated feed, identified as "Miller FDLT 45/27," which is formulated to contain no chlortetracycline, following the production of a medicated feed, identified as "Nutrena CTC 10 Gram," which is formulated to contain relatively high levels (222 lbs per ton) of the Type A, medicated article [redacted] (chlortetracycline). This resulted in cross contamination of the "Miller FDLT 45/27" with levels of chlortetracycline at 88.0 ppm.

d. On November 5, 2007, your facility produced a lot of medicated feed, identified as "Nutrabeef Cattle Grower Feed," which is formulated to contain no chlortetracycline, following the production of a medicated feed, identified as "Nutrena CTC 10 Gram," which is formulated to contain relatively high levels (222 lbs per ton) of the Type A, medicated article [redacted] (chlortetracycline). This resulted in cross contamination of the "Nutrabeef Cattle Grower Feed" with levels of chlortetracycline at 4.8 ppm.

We acknowledge your firm's response that: (1) the incident described above regarding Nutrena Naturewise Lamb and Sheep Feed represents an isolated incident; (2) the Billings, Montana facility has reviewed its sequencing and flushing procedures and has determined that the procedures for sequencing feeds are adequate and substantiated with appropriate residue testing analysis; and (3) the importance of proper sequencing and flushing has been reviewed with appropriate personnel. We further acknowledge your firm's decision to no longer manufacture the medicated feed identified as "Nutrena CTC 10 Gram" at the Billings, Montana facility. Though the firm has suspended its production of the Nutrena CTC 10 Gram, this response fails to detail any changes in the firm's sequencing procedures to prevent future cross-contamination of products.

As a manufacturer of medicated feeds you are required to use all Type A, medicated articles and Type B medicated feeds in accordance with their labeled mixing directions. However, you did not use the Type A, medicated article [redacted] in accordance with its labeled mixing directions when you added it directly into feed ration mixes rather than following the product's labeled mixing direction, which indicates to [redacted] and then [redacted] therefore, the use of the new animal drug, Type A, medicated article [redacted] (chlortetracycline), contrary to its approved labeling causes the drug to be deemed unsafe within the meaning of section 512(a)(1) of the Act [21 U.S.C. § 360b(a)(1)] and adulterated within the meaning of section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)].

We acknowledge your firm's response stating that adding this drug directly from the bag to the mixer "is a long-time standard industry practice" and that "[d]rug reconciliation records, mixer efficiency tests and laboratory assays have all substantiated this practice...." However, this response is inadequate as it fails to indicate what efforts the firm will undertake to bring its manufacturing processes into compliance with the [redacted](chlortetracycline) labeled mixing directions.

The above is not intended to be an all-inclusive list of violations. As a manufacturer of medicated and non-medicated feeds, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance with the law.

You should take prompt action to correct these violations and you should establish procedures whereby such violations do not recur. Failure to promptly correct these violations may result in regulatory and/or administrative sanctions. These sanctions include, but are not limited to, seizure, injunction, and/or notice of opportunity for a hearing on a proposal to withdraw approval of your Medicated Feed Mill License under section 512(m)(4)(B)(ii) of the Act [21 U.S.C. § 360b(m)(4)(B)(ii)] and 21 C.F.R. 515.22(c)(2).

Based on the results of the February 2008 inspection, evaluated together with the evidence before FDA when the Medicated Feed License was approved, the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of medicated feeds are inadequate to assure and preserve the identity, strength, quality, and purity of the new animal drug therein. This letter notifies you of our findings and provides you an opportunity to correct the above deficiencies in your operations.

You should notify this office in writing, within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to correct the noted violations. Your, response should include an explanation of each step being taken to correct the cGMP violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made.

Please send your written response to the Food and Drug Administration, Attention: Michael J. Donovan, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021. If you have questions regarding any issue in this letter, please contact Mr. Donovan at (425) 483-4906.

Sincerely,

/S/

Charles M. Breen District Director

Enclosure:

Form FDA 483

cc: Terry Wright, Plant Manager Cargill, Inc., 1406 Industrial Avenue, Billings, Montana 59101-3127

Sue Carson, Quality Assurance and Regulatory Manager Cargill Animal Nutrition, P.O. Box 5614, Minneapolis, Minnesota 55440-5614

Bob Church, Agricultural Specialist Montana Department of Agriculture, Feed and Fertilizer Division 303 North Roberts, Helena, Montana 59620-0201

http://www.fda.gov/foi/warning_letters/s6856c.htm

> This resulted in levels of chlortetracycline in the lamb and sheep feed up to 1000% higher than the levels indicated on the product's label. ...

holy smokes! no wonder many of us are becoming resistant to antibiotics. ...

http://staphmrsa.blogspot.com/

Chlortetracycline plus lasalocid sodium

http://www.fda.gov/cvm/FOI/141-250033106.pdf

Chlortetracycline review history and regulatory outcomes

snip...

Final review and outcomes

The APVMA completed the Chlortetracycline Review Final Report* in May 1999 but did not publish a final report because only a small number of registrants were involved. The APVMA found that the registration and approvals of the products containing chlortetracycline could be varied to meet the current requirements for continued registration.

In the final review the APVMA recommended:

cancelling approval for the use of chlortetracycline in sheep, lambs and lactating animals
ancelling approval for the use of chlortetracycline in animals producing milk for human consumption. Product labels must carry the statement, ‘Do not use in lactating cows where milk or milk products may be used for human consumption.’
increasing withholding periods for pigs, poultry, and cattle for some use patterns
withdrawing MRLs for milk, sheep, lambs and lactating animals
establishing new MRLs for pig offal (liver and kidney)
establishing MRLs for cattle, eggs and poultry.

Chlortetracycline as a topical application is currently listed in Table 5 of the MRL Standard; Table 5 applies to ‘Uses of substances where maximum residue limits are not necessary‘.

For more information please contact the Chemical Review Program on (02) 6210 4749 or by email to chemrev@apvma.gov.au

* Contact the APVMA for copies of this document

http://www.apvma.gov.au/chemrev/chlortetracyclineHistory.shtml

TSS

Community-associated methicillin-resistant Staphylococcus aureus ST8 ("USA300") in an HIV-positive patient in Cologne, Germany, February 2008

2008-03-27T18:22:00.000-07:00

Euro Surveill 2008;13(13) Published online March 2008

Community-associated methicillin-resistant Staphylococcus aureus ST8 ("USA300") in an HIV-positive patient in Cologne, Germany, February 2008

W Witte (wittew@rki.de), C Braulke, B Strommenger

Robert Koch Institut, Wernigerode, Germany

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

The first cases of community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) were reported in 1996 in Minnesota, United States (US) and were deep-seated skin and soft tissue infections and a few cases of necrotising pneumonia, mainly in children and among the Native American population [1]. A few years later, a large outbreak of CA-MRSA infections was reported in the men who have sex with men (MSM) community in California, predominantly among human immunodeficiency virus (HIV)-positive patients; data on sexual transmission was not available [2]. A recent report on the spread of CA-MRSA, mainly due to the widely disseminated strain "USA300", in numerous MSM in San Francisco and in one patient in Boston suggested sexual transmission [3], but initiated critical reviews concerning the transmission route and the corresponding public health message [4,5].
CA-MRSA "USA300", the most widely spread CA-MRSA strain in the US [6], has been detected in Germany since 2005 [7]. This clonal lineage is characterised by multilocus sequence type (MLST) ST8, spa-sequence type t008, SCCmec IVa, the presence of an additional arginine decomposition pathway (arginine catabolic mobile element (ACME) on a staphylococcal cassette chromosome (SCC)-element) with arcA as marker gene, and macrolide-resistance coded by the msrA (efflux pump) and mphB (phosphorylation) genes [7,8]. The contribution of ACME to virulence has been shown in a rabbit model [9]. The capacity of CA-MRSA "USA300" to cause invasive infections seems not to be due to production of the Panton-Valentine leukocidin cytotoxin, but rather to the synthesis of a large number of small phenol-soluble peptides, which are able to recruit and lyse neutrophilic granulocytes [10].

Here we report a case of infection with CA-MRSA ST8 ("USA300") in an HIV-positive 35-year-old MSM patient in Cologne, Germany. The isolate originated from an infected cyst in the upper abdominal area, which opened spontaneously. The patient suffered from acquired immunodeficiency syndrome (AIDS). His CD4+ T-cell count was 200/microlitre with a fully suppressed virus load due to HIV treatment. A specimen from the cyst was taken for microbiological diagnostics. Primary topical treatment was performed by instillation of Leukase beads containing trypsin, framycetin sulphate and lidocaine hydrochloride (Merck, Vienna). After obtaining the microbiology results, oral doxycyclin (200 mg per day) was included in the treatment. The infection had healed completely after 14 days. Nasal swabs were negative for MRSA.

The isolate exhibited the typical characteristics of CA-MRSA ST8 ("USA300", see above). It was resistant to oxacillin, erythromycin, ciprofloxacin, moxifloxacin and susceptible to gentamicin, oxytetracycline, clindamycin, rifampicin, cotrimoxazole, fusidic acid, linezolid, fosfomycin, tigecycline and daptomycin.

As shown in the US, CA-MRSA ST8 ("USA300") may spread rapidly in MSM communities [3]. European doctors caring for HIV-positive patients and MSM with skin and soft tissue infections should be aware of the possibility of CA-MRSA in order to provide proper care and prevent further spread.

Targeted measures include proper bacteriological diagnosis of skin and soft tissue infections in patients attending dermatological and surgical practises, as well as in HIV-positive patients. When MRSA is detected, it is likely that the infection is caused by a CA-MRSA strain. Early recognition of CA-MRSA ST8 ("USA300") is possible by PCR detection of the lukS-lukF and arcA genes [11]. Confirmation is obtained by additional typing such as spa-typing, MLST, and SCCmec [7]. Further spread can be prevented by personal, environmental and health care hygienic measures [12,13].

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

References

Naimi TS, LeDell KH, Boxrud DJ, Groom AV, Steward CD, Johnson SK, et al. Epidemiology and clonality of community-acquired methicillin-resistant Staphylococcus aureus in Minnesota. Clin Infect Dis. 2001 Oct 1;33(7):990-6.
Centers for Disease Control and Prevention (CDC). Outbreaks of community-associated methicillin-resistant Staphylococcus aureus skin infection - Los Angeles County California, 2002-2003. MMWR Morb Mortal Wkly Rep. 2003;52(5):88. Available from: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5205a4.htm
Diep BA, Chambers HF, Graber CJ, Szumowski JD, Miller LG, Han LL, et al. Emergence of multidrug-resistant, community-associated, methicillin-resistant Staphylococcus aureus clone USA300 in men who have sex with men. Ann Intern Med. 2008;148(4):249-57.
Skiest D, Brown K, Cooper TW, Hoffman-Roberts H, Mussa HR, Elliott AC. Prospective comparison of methicillin-susceptible and methicillin-resistant community associated Staphylococcus aureus infections in hospitalized patients. J Infect. 2007;54(5):427-34.
Centers for Disease Control and Prevention (CDC). CDC statement on MRSA in men who have sex with men. 2008 Jan 16. Available from: http://www.cdc.gov/od/oc/media/pressrel/2008/t080116.htm
Van de Laar MJW, Monnet DL, Herida M. Multidrug-resistant methicillin-resistant Staphylococcus aureus (MRSA) strain in a men-who-have-sex-with-men (MSM) community in the United States: comment. Euro Surveill. 2008;13(3). Available from: http://www.eurosurveillance.org/edition/v13n03/080117_1.asp
Witte W, Strommenger B, Cuny C, Heuck D, Nuebel U. Methicillin-resistant Staphylococcus aureus containing the Panton-Valentine leucocidin gene in Germany in 2005 and 2006. J Antimicrob Chemother. 2007;60(6):1258-63.
Tenover F, McDougal L, Goering RV, Killgore G, Projan SJ, Patel JB, et al. Characterization of a strain of community-associated methicillin-resistant Staphylococcus aureus widely disseminated in the United States. J Clin Microbiol. 2006;44(1):108-18.
Chambers HF. Deconstructing virulence of the community MRSA clone USA300. in NARSA 8th Annual Meeting. 2007. Reston, VA, USA, March 5-6. Available from: http://www3.niaid.nih.gov/topics/antimicrobialResistance/PDF/futureMedicineMRSAeditorial.pdf
Wang R, Braughton KR, Kretschmer D, Bach TH, Queck SY, Li M, et al. Identification of novel cytolytic peptides as key virulence determinants. Nature Med. 2007;13(12):1510-4.
Strommenger B, Braulke C, Pasemann B, Schmidt C, Witte W. Multiplex PCR for rapid detection of Staphylococcus aureus isolates suspected to represent community-acquired strains. J Clin Microbiol. 2008;46(2):582-7.
Cohen PR. Community-acquired methicillin-resistant Staphylococcus aureus skin infections: implications for patients and practitioners. Am J Clin Dermatol. 2007;8(5):259-70.
Wiese-Posselt M, Heuck D, Draeger A, Mielke M, Witte W, Ammon A et al. Successful termination of a furunculosis outbreak due to lukS-lukF-positive, methicillin-susceptible Staphylococcus aureus in a German village by stringent decolonization, 2002 - 2005. Clin Infect Dis. 2007;44(11):88-95.

Citation style for this article: . Community-associated methicillin-resistant Staphylococcus aureus ST8 ("USA300") in an HIV-positive patient in Cologne, Germany, February 2008. Euro Surveill 2008;13(13). Available online: http://www.eurosurveillance.org/edition/v13n13/080327_3.asp

http://www.eurosurveillance.org/edition/v13n13/080327_3.asp

tss

Methicillin-Resistant and -Susceptible Staphylococcus aureus Sequence Type 398 in Pigs and Humans

2008-03-20T14:22:00.001-07:00

Volume 14, Number 3–March 2008

Dispatch

Methicillin-Resistant and -Susceptible Staphylococcus aureus Sequence Type 398 in Pigs and Humans

Alex van Belkum,* Damian C. Melles,* Justine K. Peeters,* Willem B. van Leeuwen,* Engeline van Duijkeren,† Xander W. Huijsdens,‡ Emile Spalburg,‡ Albert J. de Neeling,‡ and Henri A. Verbrugh,* on behalf of the Dutch Working Party on Surveillance and Research of MRSA (SOM)1
*University Medical Center Rotterdam, Rotterdam, the Netherlands; †University of Utrecht, Utrecht, the Netherlands; and ‡National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands

Suggested citation for this article

Abstract
Methicillin-resistant Staphylococcus aureus sequence type 398 (ST398 MRSA) was identified in Dutch pigs and pig farmers. ST398 methicillin-susceptible S. aureus circulates among humans at low frequency (0.2%) but was isolated in 3 human cases of bacteremia (2.1%; p = 0.026). Although its natural host is probably porcine, ST398 MRSA likely causes infections in humans.

snip...

Conclusions
The massive colonization of Dutch pigs with a single sequence type of MRSA was unexpected (12). Molecular strain typing was initially compromised because PFGE failed (14). Spa gene sequencing (13) showed heterogeneity in the ST398 MRSA lineage with types t011 and t108, which are closely related, covering >75% of all isolates. Hence, 1 or 2 new MRSA lineages had been discovered. We found a degree of genetic association between spa types and the presence of certain SCCmec cassettes, which suggests bacterial evolution and horizontal DNA exchange in the zoonotic reservoir.

We found that ST398 is rare among Dutch MSSA strains colonizing healthy persons (2 [0.2%] of 829 strains). However, a relatively high number of MSSA isolates homologous to the ST398 MRSA were derived from bacteremic patients (3 [2.1%] of 146; p = 0.026). These 3 bacteremia isolates were not related epidemiologically; they were isolated from different patients in different medical departments over an extended period. This finding suggests that these MSSA strains are quite virulent. The strict segregation of ST398 strains (Figure 1, panel A; Figure 2) corroborates that the strains belong to a separate biotype associated with pigs (15).

Our findings pose a warning to public health surveillance: if the ST398 MSSA virulence toward humans would be maintained within the ST398 MRSA lineage from pigs, care should be taken not to introduce this strain into humans. We consider it to be likely that ST398 MRSA from pigs is capable of causing serious infection in humans even though its primary host seems to be pigs.

Dr van Belkum is with the Department of Medical Microbiology and Infectious Diseases, University Medical Center Rotterdam, Rotterdam, the Netherlands. His research interests include MRSA.

References

snip...full text ;

http://www.cdc.gov/eid/content/14/3/479.htm

Methicillin-resistant Staphylococcus aureus (MRSA)

http://staphmrsa.blogspot.com/2008/03/iceid-2008-methicillin-resistant.html

ICEID 2008 Foodborne Disease Outbreaks Leafy Greens and Meats

International Conference on Emerging Infectious Diseases 2008
Slide Sessions and Poster Abstracts

http://staphmrsa.blogspot.com/2008/03/iceid-2008-foodborne-disease-outbreaks.html

TSS

ICEID 2008 Foodborne Disease Outbreaks Leafy Greens and Meats

2008-03-19T16:49:00.000-07:00

Page 1 of 262
International Conference on Emerging Infectious Diseases 2008
Slide Sessions and Poster Abstracts

Foodborne Disease Outbreaks Associated with Leafy Greens, 1973–2006

K. M. Herman, T. L. Ayers, M. Lynch; Centers for Disease Control and
Prevention, Atlanta, GA.

Background: Several recent large outbreaks have been associated with leafy
green foods in the United States, such as Escherichia coli O157:H7 infections due to spinach;
however, the characteristics of all reported outbreaks due to leafy greens have not been described. The Centers for Disease Control and Prevention conducts surveillance for foodborne disease outbreaks (FBDO) investigated by local and state health departments in the United States. Methods: We reviewed data from the FBDO surveillance system for 1973-2006. A leafy green-associated FBDO is defined as two or more illnesses due to the consumption of a single leafy green food item (lettuce, cabbage, mesclun mix, spinach) or a salad item containing one or more leafy greens. These data were compared with U.S. leafy greens per capita availability, a proxy for leafy green consumption. Results: Among 10,421 FBDO reported during 1973-
2006, 502 (4.8%) outbreaks, 18,242 (6.5%) illnesses, and 15 (4.0%) deaths were associated with leafy greens. Among leafy green-associated FBDO with a confirmed etiology, Norovirus was responsible for 196 (58.3%) outbreaks, followed by Salmonella, 35 (10.4%) outbreaks, and
Escherichia coli O157:H7, 30 (8.9%). The median size of leafy green-associated outbreaks (18 illnesses) was twice the median size of non-leafy green-associated outbreaks (9). During 1986-1995, U.S. leafy green consumption increased 17.2% from the previous decade. During the same period, the proportion of all FBDO due to leafy greens increased 59.6%. Likewise, during 1996-2005 leafy green consumption increased 9.0% and leafy greenassociated outbreaks increased 38.6%. In 296 (69.4%) outbreaks, leafy greens were served at a restaurant; 11 (2.2%) involved cases in multiple states. Conclusions: Leafy greens are an important cause of FBDO and may transmit pathogens with human or animal reservoirs. The proportion of FBDO due to leafy greens has increased, and cannot be accounted for completely by an increase in leafy green
consumption. Contaminated leafy greens may cause restaurant-associated or widespread outbreaks. Efforts by local, state, and federal agencies to control leafy green outbreaks should span from the point of harvest to the point of preparation.

Board 21. Fresh produce outbreaks in Australia, 2001-2006

M. D. Kirk1, K. Fullerton1, J. Gregory2; 1OzFoodNet, Canberra, AUSTRALIA,
2OzFoodNet, Department Human
Services, Victoria, AUSTRALIA.

Background: Recent outbreaks in Australia and abroad have highlighted the role of fresh produce in foodborne disease outbreaks. Since fresh produce is often eaten without
cooking, its outbreak potential can be significant. Methods: Data from the OzFoodNet Outbreak Register from January 2001 to June 2005 were reviewed. OzFoodNet Quarterly and Annual Reports (published and unpublished) from July 2005 through December 2006 were also reviewed. Produce-related outbreaks were defined as outbreaks of foodborne or suspected foodborne transmission where the confirmed or suspected vehicle included fresh, uncooked produce. Results: From January 2001 through June 2005 there were 1767 reported gastroenteritis outbreaks recorded. Of these outbreaks, 426 (24%) were either foodborne (157, 37%) or suspected foodborne (269, 63%). Sixteen (4%) of these outbreaks were identified as produce-related. An additional 9 produce-related outbreaks were identified in the review of quarterly and annual reports. These 25 outbreaks affected at least 686 people, with 51 people hospitalized and no fatalities. The mean number of people affected in these outbreaks was 30 people, with a range from 2 to 125 people. These outbreaks occurred in association with food served at restaurants (44%), primary produce (20%), and fastfood/ takeaway food (20%). These outbreaks were caused by Salmonella (60%), followed by unknown aetiology (20%), norovirus (12%), and Campylobacter (8%). Conclusions: Fresh produce causes considerable foodborne
disease in Australia. Fresh produce is particularly vulnerable to causing outbreaks due to the lack of an adequate killstep for pathogens.

Board 95. Tomato Handling Policies and Practices in Restaurants

E. G. Kirkland, V. J. Radke, C. A. Selman; CDC, EHS-Net, Atlanta, GA.

Background: Recently, several foodborne illness outbreaks have been associated with tomatoes served in restaurants. Prevention of foodborne illness outbreaks requires proper food storage and preparation practices; these tomato outbreaks suggest that tomatoes are being stored and prepared improperly in restaurants. Yet relatively little data exists on tomato storage and preparation policies and practices in restaurants. Thus, the purpose of this study is to gain a better understanding of how tomatoes are stored and prepared in restaurants. Methods: Data were collected in 450 restaurants through interviews with restaurant managers and observations of tomato storage, washing and cutting in restaurant kitchen environments. This study was conducted by the Environmental Health

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Specialists Network (EHS-Net). EHS-Net is a collaboration involving the Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA), and nine Emerging Infections Program sites (California, Connecticut, Georgia, Iowa, Minnesota, New York, Rhode Island and Tennessee); these partners have come together in an effort to better understand the environmental causes of foodborne illness. Results: The median temperature of prepared tomatoes in storage and holding was 44°F degrees; the median temperature of cut tomatoes in storage and holding was 43°F degrees. In 94% of restaurants, managers reported that tomatoes were washed; in 83% of washing observations, tomatoes were rinsed or held under running water and in 18% of washing observations, tomatoes were soaked or immersed in water. Produce-only cutting boards were used in 51% of tomatocutting
observations, and gloves were used in 64% of observations. Conclusions: Some good tomato handling practices were observed. For example, most restaurants reported washing their tomatoes, and gloves were used in the majority of tomato-cutting observations. However, some practices did not meet FDA recommendations for preventing pathogen contamination and proliferation on tomatoes- cut tomatoes were stored above 41 degrees, tomatoes were washed by soaking in water rather than by placing under running water, and produce only cutting
boards were not always used. These data indicate that education concerning safe tomato handling practices is needed in restaurants.

Foodborne & Waterborne Infections

Board 87. Foodborne Disease Outbreak Trends, and Sources and Timeliness of
Detection in Connecticut, 2004-2007

D. Mlynarski, Q. Phan, T. Rabatsky-Ehr, K. Purviance, J. Brockmeyer, J. Krasnitski, A. Nepaul, L. LoBianco, K. Frenette, P. Mshar, J. L. Hadler; Connecticut Department of Public Health,
Hartford, CT.

Background: It is critical to public health preparedness (PHP) to understand the epidemiology of outbreaks, and means and timeliness of their detection. In Connecticut (CT), foodborne
disease outbreaks (FOs) are considered public health emergencies reportable by telephone to state and local public health authorities. We examined 3.5 years of FO surveillance in CT as part of a broader effort at enhancing PHP-related surveillance. Methods:CT data reported to CDC by the electronic Foodborne Outbreak Reporting System was reviewed for January 2004-June 2007. The number, causative agents, settings and food vehicles implicated were
examined. Methods of detection were summarized; median time delay from first illness onset to public health notification was calculated. Results: From 1/1/04-6/30/07, 58 FOs were reported. The number increased annually from 13 to 19 between 2004 and 2006 with 10
FOs in the first 6 months of 2007. Causative agents included norovirus (62%), bacterial pathogens (28%), toxins (3%) and parasites (2%). The increase from 2004 to 2006 was mainly due to norovirus (7 to 12). Overall, 64% of FOs were associated with contamination or mishandling of food at food service establishments and 19% with widely distributed contaminated food items. Private citizens reported 62% (median 3-day delay) and clinicians reported 12% (median 1-day delay) of FOs. Public health surveillance, including routine Pulsed Field Gel Electrophoresis (PFGE) of selected bacterial pathogens, detected 21% (median 26-day delay). Most (71%) PFGE-identified outbreaks were associated with widely distributed food items. Conclusions: Reported FOs have been increasing, in part driven by an increase in those due to norovirus. Astute citizens and clinicians are the most important sources of rapid detection and
reporting. Clinicians have a responsibility to report suspected outbreaks and assist in their detection by ordering appropriate diagnostic testing on persons with acute gastrointestinal
illness. Active public health surveillance, including routine PFGE typing, is important to detection of outbreaks caused by widely distributed contaminated food items; however, it is not very timely. Efforts are needed to improve timeliness of detection of outbreaks, particularly those using molecular subtyping methods such as PFGE.

Board 88. Indiana Outbreak of Salmonella I 4,[5],12:i:- monophasic at a
Supermarket Deli – 2006

L. Granzow1, S. Gorsuch1, B. Swearingen2; 1Indiana State Department of
Health, Indpls, IN, 2Johnson County Health
Department, Greenwood, IN.

Background: On July 11, 2006, the Indiana State Department of Health (ISDH) initiated an investigation in response to an increase in salmonellosis in two adjacent counties.
Geographic information system (GIS) mapping confirmed the clustering of cases at the respective north-south borders of the two counties. The most common exposure (76.2%) among cases was a supermarket (SM) location, with 78.9% of cases having purchased items from
the deli. Pulse-field gel electrophoresis (PFGE) confirmed 199 cases in a 2-enzyme matched outbreak of Salmonella I 4,[5],12:i:- monophasic, an emerging serotype. The PFGE pattern was unique during the outbreak period on the national PulseNet database with a rare Bln I pattern (0.35%). The multiple-locus variable-number tandem repeat analysis (MLVA) pattern was also unique (N of I 4,[5],12:i:- database = 450). The outbreak ended after a near 4-month period, including 15 counties and 2 out-of state residents. A knife block at the SM was a 2-enzyme match for the outbreak strain. Methods: The ISDH conducted a case-control study (1:1, N=32), matched by zip code, using a reverse digit dialing system. The study case definition included those with onset dates in July and met the clinical definition of salmonellosis. The Fisher’s exact test (SAS 9.1) was used to evaluate the association between illness and exposure. Results: Of the five supermarkets reported, a statistically significant relationship (a = 0.05) was found
between illness and shopping at the SM deli (OR=21.21, p<0.0001).> 4 µg/mL) increased significantly (p=0.0158) from 2002 (13.8%) to 2005 (19.6%), and dropped slightly in 2006 (18.9%)
following the ban of fluoroquinolone use in poultry production. In C. jejuni from chicken breast, however, CipR was present in 15.1% of isolates from 2005 and 16.9% in 2006. During the five year testing, TetR increased from 27.6% to 47.8% overall. EryR each year was present
in <1%> 5 antimicrobials was AZI-CLI-ERY-TEL-TET. C. coli showed higher proportion of
MDR than C. jejuni. The PFGE results showed that Campylobacter genetically were very diverse, however certain clones were widely dispersed in different meat brands from different store chains in all five years. Conclusions: Campylobacter, including antimicrobial resistant strains, persist in retail chicken meats and provide a reservoir of resistant strains in the food supply.

Antimicrobial Resistance

Board 6. Salmonella enterica serovar Heidelberg from Retail Meats: Results:
of the National Antimicrobial Resistance Monitoring System (NARMS): 2002-2006.

S. Zhao, E. Hall-Robinson, A. Glenn, S. Friedman, J. Abbott, S. Ayers, P.
McDermott; Food & Drug Administration, Laurel, MD.

Background: Salmonella enterica serovar Heidelberg is frequently associated with foodborne illness in humans, and is commonly isolated from poultry and their derived meats. A recent upsurge in antimicrobial resistance in this serovar has been recognized. There are few data on the prevalence, antimicrobial susceptibility, and genetic diversity of S. Heidelberg isolates in retail meats. Methods: We compared the prevalence of S. Heidelberg in a sampling of 20,294 meats, including chicken breast, ground turkey, ground beef and pork chops collected during
2002-2006 for the National Antimicrobial Resistance Monitoring System (NARMS). Isolates were analyzed for

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antimicrobial susceptibility and compared genetically using pulsed-field gel electrophoresis (PFGE). Results: A total of 297 S. Heidelberg isolates were recovered, representing 22%(297/1372) of all Salmonella serovars from retail meats. Among the 297 isolates, 178 (60%) from ground turkey, 109 (37%) from chicken breast and 10 (2%) from pork chop; no S. Heidelberg was found in ground beef. A total of 197 (66%) of the isolates were resistant to at least one of
the 15 antimicrobial agents tested and 49 (16%) of the isolates were resistant to >5 antimicrobials. Five isolates (1.7%) were resistant to >9 antimicrobials, all of which were recovered form ground turkey. The proportion of resistance to different antimicrobials were: tetracycline (40%), streptomycin (38%), sulfamethoxazole (30%), gentamicin (27%), and kanamycin (21%), ampicillin (19%), amoxicillin-clavulanic acid (10%), cefoxitin (9%), ceftiofur
(9%), chloramphenicol (1%), and nalidixic acid (1%). Resistance was consistently more prevalent in S. Heidelberg from ground turkey than from chicken breast. All isolates were susceptible
to amikacin, ceftriaxone, ciprofloxacin and trimethoprim/ sulfamethoxazole. PFGE using XbaI and BlnI generated 107 patterns. Certain clones were widely dispersed in different types of meats and meat brands from different store chains in all three sampling years. Conclusions: These date indicate that S. Heidelberg is a common serovar in retail poultry meats, and includes clones of multidrug-resistant strains.

Board 18. Human Health Burden of Acute Diarrheal Illness in the United
States, FoodNet Population Survey, 2006-2007

L. B. Moyer1, P. Clogher2, C. Fuller3, T. F. Jones4, A. Lasher5, D. M.
Norton6, S. Solghan7, M. Tobin-D'Angelo8, O.
Henao9; 1CDC and VA Medical Center, Atlanta, GA, 2CT EIP, New Haven, CT, 3MN
Dept of Health, St Paul, MN, 4TN
Dept of Health, Nashville, TN, 5FDA, College Park, MD, 6CA EIP, Oakland, CA,
7NY Dept of Health, Albany, NY, 8GA
Div of Publ Health, Atlanta, GA, 9CDC, Atlanta, GA.

Background: Foodborne pathogens cause an estimated 76 million illnesses each year. Although most illnesses are self-limiting, the human health burden is substantial and includes healthcare provider visits, medications, laboratory tests, hospitalizations, and time missed from work. We describe the human health burden of acute diarrheal illness using data from the 2006-2007 FoodNet Population Survey. Methods: During 2006-2007, FoodNet conducted a 12-month population-based survey in 10 sites using a standard random-digit dialing methodology.
Demographic information was collected and respondents were asked about illness and activities in the month beforethe interview. Acute diarrheal illness was defined as >3 loose stools in 24-hours lasting >1 day or resulting in impairment of daily activities. Persons with a chronic illness in which diarrhea was a major symptom were excluded. Weighted proportions were calculated to adjust for study design and age and sex. Results: The weighted prevalence
of acute diarrheal illness in the month prior to interview was 6.9% (95% CI 6.6-7.2). Acute diarrheal illness prevalence was greatest among those <5>65 years old (4.4%, 95%
CI 3.5-5.3). The mean duration of diarrhea was 4 days (median 2) and 1.7% reported bloody diarrhea. Of the 20.0% who visited a medical care provider, 26.7% went to a doctor’s office or
clinic more than once, 13.0% went to an emergency department, 1.0% were admitted to a hospital overnight and an additional 2.3% spent more than one night in the hospital. Stool specimens were submitted from 4.0% of persons reporting acute diarrheal illness, 32.9%
took anti-diarrheal medications and 10.6% used antibiotics. Of those who had a job during this time period (52.0%), 33.2% missed time from work because of their or their child’s illness
(median 2 days). Of those attending school (7.2%), 66.3% missed time from school because of the illness (median 2 days). Conclusion: Acute diarrheal illness remains an important human health burden causing substantial personal and societal costs from multiple healthcare contacts and days missed from work or school. Continued efforts are needed to identify the causes and risk factors for illness; thus, helping to direct intervention and prevention efforts to reduce the burden of illness.

Board 19. Salmonella Bacteriuria in New York State FoodNet Counties,
2002-2006

G. L. Smith1, S. M. Zansky2, D. L. Hoefer2, J. B. Karr3, N. L. Spina2, S. M.
Solghan2, T. P. Root4; 1NYSDOH, Geneva,
NY, 2NYSDOH, Albany, NY, 3NYSDOH, Rochester, NY, 4Wadsworth Center
Laboratories-NYSDOH, Albany, NY.

Background: Salmonellosis is a major cause of foodborne illness in the U.S. Commonly associated with gastrointestinal illness, it can also cause extra-intestinal illness including urinary tract infections. Recent national trends indicate Salmonella bacteriuria increasing in incidence and as a proportion of all Salmonella, especially among elderly women. Analysis of Salmonella bacteriuria in 34 New York State (NYS) Emerging Infections Program (EIP)
FoodNet counties was conducted to look for similar trends. Methods: The NYS FoodNet program has conducted population-based active surveillance for laboratory-confirmed cases of
infection of Salmonella. Using the NYS Department of Health (NYSDOH) Communicable Disease Electronic Surveillance System (CDESS) and the Clinical Laboratory Information System (CLIMS), confirmed cases of Salmonella identified between 2002-2006 were included
in this analysis. The most invasive source for each case is recorded. Data was examined to compare incidence rates of Salmonella isolated from urine and proportion of urine isolates by gender and age group. Results: 2337 confirmed cases of Salmonella were identified between 2002-2006. Of 2333 cases with a known specimen source, 189 cases were isolated from urine (8.1%). The annual proportion of urine isolates ranged from 5.1% (2002) to 11.1% (2005).
The incidence rate of Salmonella bacteriuria increased from 0.8 cases per 100,000 persons in 2002 to 1.1/100,000 in 2006 with the highest rate of 1.3/100,000 in 2005. Most cases isolated from urine occurred among women (88.4%). For both sexes, incidence from urine increased with age, beginning around 50 years of age with the greatest percentage of cases attributable to those >70 years. Conclusions: Salmonella bacteriuria has long been identified in

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NYS residents but recently represent a greater proportion of the total cases. The majority of cases occur in elderly females similar to national reports. Collecting and reporting specimen
source is an important component of foodborne disease surveillance, helping to identify changes in the epidemiology of those illnesses. Possible change in test practices, role of urine catheters, and urine predilection of some Salmonella serotypes may contribute to the
increased incidence of Salmonella bacteriuria in NYS and warrant further study.

Board 239. Antimicrobial Resistant Salmonella from Retail Chicken in
Pennsylvania 2006-2007

S. C. Rankin1, N. M. Mikanatha2, D. Tewari3, A. Russo3, R. Localio1, S.
Altekruse4, C. Sandt5, E. Lautenbach1, J.
Tait2, M. Hydock3, S. Reynolds5, N. G. Warren5, T. M. Chiller6, D. G.
White7; 1University of Pennsylvania,
Philadelphia, PA, 2Pennsylvania Department of Health, Harrisburg, PA,
3Pennsylvania Department of Agriculture,
Harrisburg, PA, 4National Institutes of Health, Bethesda, MD, 5Pennsylvania
Department of Health, Lionville, PA,
6Centers for Disease Control and Prevention, Atlanta, GA, 7Food and Drug
Administration, Laurel, MD.

Background: Infections caused by antibiotic-resistant Salmonella strains are
associated with more severe

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illnesse, and higher mortality than those due to susceptible strains. Consumption of chicken is a known risk factor for salmonellosis. However, the prevalence of resistant Salmonella in poultry meat and their relationship to human Salmonella isolates has not been well-characterized. Methods: Chicken was purchased from a stratified random sample of retail outlets in a three county region of Central Pennsylvania for 12 months during 2006-2007. Each month 30 samples were purchased from retail outlets. The samples included prepackaged and open display poultry. Information was obtained on USDA establishment numbers and
organic/antibiotic-free status from package labels, where available. Isolates were characterized by serotyping, antibiotic susceptibility testing and pulsed-field gel electrophoresis (PFGE). Antibiotic resistant strains were analyzed for the presence of resistance genes by PCR. PFGE profiles of antibiotic resistant isolates were compared with human Salmonella isolates from the state public health laboratory during the study period. Results: Salmonella was isolated
from 84 (22%) of 378 samples. The most common serotypes were Typhimurium 28 (33%), Kentucky 24 (29%), and Enteritidis 22 (26%). 45 isolates showed resistance to one or more drugs; 40% demonstrated resistance to at least five drugs. 8/45 (18%) resistant isolates had a blaCMY ß-lactamase gene. The packaged chicken originated from 20 different establishments. Salmonella isolation was associated with poultry from particular establishments (p=0.007, chi sq=37.6, df=19). In one establishment that processed only organic poultry, 10 (53%) of 19 samples were positive. PFGE patterns of Typhimurium and Kentucky isolates from chicken matched patterns in the human database. Conclusion: The occurrence of drug-resistant Salmonella in retail chicken is a public health concern. This study identified strains with
reduced susceptibility to expanded-spectrum cephalosporins and isolates from humans and chickens with the same PFGE profiles. The study also identified an association of Salmonella
contamination with poultry from specific establishments. These results indicate the need for enhanced inter-agency surveillance.

Board 225. Longitudinal Study of Antimicrobial Resistance among Escherichia
coli Isolated from Integrated Multi-site Cohorts of Humans and Swine

W. Alali1, H. M. Scott1, R. Harvey2, B. Norby1, B. Lawhorn1, S. Pillai1;
1Texas A&M University, College Station, TX,
2USDA-ARS-SPARC, College Station, TX.

Background: Many studies have attempted to link antimicrobial use in food animal agriculture with an increased risk of antimicrobial-resistant (AR) bacterial levels in humans. Methods: We examined the relationship between the prevalence of AR E. coli isolated from human wastewater and swine fecal samples and the risk factors: (host species, production type (swine), vocation (human swine workers, non-workers, and slaughter-plant workers), and season) in a multi-site housing, vertically integrated swine and human population agri-food system. Human and swine E. coli (N = 4048 and 3485, respectively) isolated from wastewater and
fecal samples were tested for antimicrobial susceptibility using the SensititreTM broth microdilution system. Results: There were significant (P < 0.05) differences in AR isolates: 1) between host-species with swine at higher risk for tetracycline, kanamycin, ceftiofur, gentamicin, streptomycin, chloramphenicol, sulfisoxazole, and ampicillin, 2) swine production group was significantly associated with AR with purchased boars, nursery piglets, and breeding boars at a higher risk of Page 190 of 262 resistance to streptomycin and tetracycline, and 3) human swine worker cohorts exhibited lowered sulfisoxazole and cefoxitin prevalence compared to non-workers, while slaughter-plant workers exhibited elevated cefoxitin prevalence compared to non-workers. High variability among seasonal samples over the 3-year period was observed. There were significant differences in multiple resistance isolates between host species, with swine at higher risk than humans of carrying multi-resistant strains, slaughter-plant workers at higher risk than swine non-workers; however, there were no significant differences in multiple resistance isolates within swine by production group. Conclusions: Occupational exposure to slaughter facilities appeared to be associated with an increased relative odds for the prevalence of cefoxitin resistance and multiple resistance compared to swine non-workers.

A Veterinary Curriculum in the Appropriate Use of Antibiotics

P. C. Bartlett; Michigan State University, E. Lansing, MI. Background:

Debate still continues regarding the relative importance of agricultural antibiotic usage in fostering antimicrobial resistance (AR) among human pathogens. This debate may have delayed the development of educational materials aimed at promoting the prudent and judicious use of antibiotics in veterinary medicine. However, a consensus exists that unnecessary or wasteful usage should be curtailed whenever possible. Methods: The U.S. Centers for Disease Control and Prevention (CDC) funded the development of an interactive and multi-media educational web site to aid in teaching veterinary students about their responsibilities and obligations to curtail the unnecessary use of antibiotics. The overall purpose is to preserve antibiotic efficacy for both humans and animals. Audio, video, interactive questions and animation are used to make the presentation varied and entertaining. Written for veterinary students, the site also has applicability to others in the food animal industries. Results: The web site is designed to supplement existing courses in public health, epidemiology, pharmacology and species-specific veterinary medicine. The introductory module emphasizes the interconnectedness of animal and human health as it follows an outbreak investigation scenario to teach basic microbiologic and epidemiologic principles of AR. Also taught are methods for determining AR and the importance of AR to public health. Species-specific modules regard international issues and multiple clinical situations for dairy cattle, beef cattle, exotic animals and swine. Future modules will address

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companion animals and poultry. Emphasis is on therapeutic situations when antimicrobial agents are often used unnecessarily when alternative treatment methods are available, when the use of antibiograms (susceptibility profiles) is possible or when antibiotic treatment may be less efficacious and economical than are available preventive medicine procedures. Conclusions: This web site is being written for training veterinary students throughout the USA, but it will be freely available to the international public. The web site is due for release in 2008. Search: CDC Get Smart on the Farm or find the link at the CDC web site:

http://www.cdc.gov/narms/get_smart.htm

or

www.cvm.msu.edu

Antimicrobial Resistance

Board 79. Antimicrobial Resistance in Salmonella Isolates Recovered from Cattle at Slaughter

P. J. Fedorka-Cray1, J. G. Frye1, M. Rose2, N. Anandaraman3, J. Haro1; 1USDA-ARS, Athens, GA, 2Intervet Innovation GmbH, Schwabenheim, GERMANY, 3USDA-FSIS, Washington, DC.

Background: Since 1997, the animal arm of the National Antimicrobial Resistance Monitoring System (NARMS) has monitored changes in antimicrobial susceptibilities of Salmonella isolates from animal origin. Additionally, since 2000, susceptibility of bovine Salmonella isolates collected in the US has been monitored against the 4th generation cephalosporins (4-GC) cefquinome, exclusively developed for veterinary medicine, and cefepime. Cephalosporins are used extensively to treat human and cattle diseases. To identify emerging resistance patterns, resistance trends to the cephalosporins (ceftriaxone, ceftiofur, cefoxitin and cefquinome) in Salmonella isolates collected from cattle at slaughter were analyzed. Methods: Salmonella enterica isolates (n=7,199) obtained from cattle at federally inspected slaughter/processing plants during 1997 - 2006 and submitted to NARMS were tested for minimum inhibitory concentrations (MICs) using a custom panel of antimicrobials. Isolates collected during 2000-2006 (n=4,685) were also tested on a second panel with cefquinome and cefepime. Results: Resistance to ceftriaxone remained below 1%, except in 2005 when resistance increased to 2.1%. From 1997 to 2005, resistance to ceftiofur increased from 0% to 21.6%, with the exception of 2004 when it decreased to 13.3%. Resistance decreased again in 2006 to 18.9%. A similar pattern was observed for cefoxitin (testing started in 2000). Cefoxitin resistance increased from 2000 to 2005 from 9.1% to 19.8%, except in 2004 when it decreased to 13.2%. As with ceftiofur, a decrease was observed in 2006 when resistance was 17.9%. From 2000 to 2006 the MIC50 of cefquinome remained at 0.06 µg/ml, except in 2002 when the MIC50 increased by one dilution to 0.12 µg/ml. The highest MIC90 for cefquinome was 1.0 µg/ml in 2002 and 2005. MICs of cefepime were generally about one dilution step below those of cefquinome. Changes in resistance for all drugs were in large part driven by serotype, particularly S. Newport, Reading, Typhimurium and Agona. Conclusions: Salmonella enterica isolates remained highly susceptible to the human 3-GC ceftriaxone and the 4-GCs cefquinome and cefepime. Overall, an increase in both veterinary 3-GC ceftiofur and human 2-GC cefoxitin has been observed at similar levels and appears to be serotype dependent.

Board 80. Prevalence of Antibiotic Use, Knowledge and Attitudes Toward Antibiotic-free Meat

S. C. Rankin1, N. M'ikanatha2, R. Dewar2, E. Lautenbach1; 1University of Pennsylvania, Philadelphia, PA, 2Pennsylvania Department of Health, Harrisburg, PA.

Background: Inappropriate use of antibiotics is a major public health concern as it contributes to antimicrobial resistance. Understanding consumers’ knowledge and attitudes can inform multifaceted actions to achieve judicious use of antibiotics. Methods: In 2006 questions regarding antibiotic prescriptions and attitudes toward antibiotic-free meat were asked as part of Pennsylvania Behavioral Risk Factor Surveillance System (BRFSS). Results: Among Pennsylvania adults, 38.1% (95% CI, 36.4-39.8%) responded they had been prescribed antibiotics in the previous 12 months and 43.9% (95%CI, 41.1-46.7%) of these had received at least two prescriptions. Among adults taking antibiotics in the past year, 11.4% (95%CI, 9.6-13.6%) had not completed the course of treatment. Prescriptions for self-identified diagnoses usually not caused by bacteria (e.g., cough or cold) were reported by 30.3% (95%CI, 27.7-33.1%). Knowledge about use of antibiotics in animal husbandry varied by demographic characteristics (Figure): 53.6% (95% CI, 52.8%-55.4%) of non-Hispanic whites were aware of antibiotics in feed, whereas 42% (95% CI, 34.8-50.1%) of African Americans and 39.8% (95%CI, 29.0-51.7%) of Hispanics were aware. Knowledge also increased with age, education, and income. Overall 26.2% (95% CI, 24.6- 31.9%) of the survey participants reported that that they try to purchase antibiotics-free meat. Conclusion: Inappropriate prescriptions and noncompliance with treatment regimens call for simultaneous interventions among clinicians and patients. To promote judicious use of antibiotics in food animals, additional measures to engage consumers are needed.

see full text of these abstracts 262 pages ;

http://www.cdc.gov/eid/content/14/3/ICEID2008.pdf

TSS

ICEID 2008 Methicillin-Resistant Staphylococcus aureus MRSA

2008-03-19T14:54:00.000-07:00

Methicillin-Resistant Stapylococcal Infections

Trends in Invasive Infection with Methicillin-resistant Staphylococcus
aureus (MRSA) in Connecticut, 2001-2006

S. Petit1, Z. Fraser1, M. Mandour2, J. L. Hadler1; 1Connecticut Department
of Public Health, Hartford, CT,
2Connecticut Department of Public Health Laboratory, Hartford, CT.

Background: In 2007, CDC published an article that described the epidemiology of invasive
MRSA infections in 2004-05 in 9 sentinel sites, including Connecticut (CT). The CT system has been in place since 2001 and provides an opportunity to examine trends in the 3 major groupings of MRSA by place of onset and relationship to healthcare: hospital-onset (HO) vs. community-onset but healthcareassociated (HA) or community-associated (CA) MRSA. Methods: Cases identified from laboratory reporting of MRSA isolates from normally sterile body sites were classified after medical record review as HO (isolate >2 days after hospital admission), HA (hospital admission, surgery, dialysis, or long-term care facility stay in the past year, a history of MRSA, or an indwelling device); or CA (by exclusion). A systematic sample of blood isolates were typed by pulsed-field gel electrophoresis (PFGE). Results: In
2001-2006, 5464 cases of invasive MRSA were reported; 34.5% HO, 58.9% HA and 6.6% CA. Annual incidence overall (26.2 per 100,000) and of HA-MRSA (15.4) was stable. However, incidence of HOMRSA decreased (10.0 to 7.6) while CA incidence increased (1.1 to 2.8, p<0.01 p="0.02)." p =".049,"> 1 hospitalization (80%, [268/335] vs. 63% [245/390], P <.0001) and had > 2 infections (33%, [110/335]) vs. 23% [88/390], P =.002) respectively. There were twice as many deaths during the 6-month follow up period among patients with MRSA infection (24%,
79/335) as among patients with MSSA infection (12% 45/390, OR 2.4, 95% CI 1.6-3.5, P < .0001). After adjustment for age and CH-IND, this difference remained significant (OR 1.9, 95% CI 1.2-2.9, P =.005). There was clinical evidence that SA infection caused or clearly contributed to death in 28% (35/124) of all deaths; 7% (25/335) among those with MRSA infection and 3% (10/390) among those with MSSA infection. After adjustment for age, those with MRSA infection were almost 3 times more likely than those with MSSA infection to die of SA disease (OR 2.8, 95% CI 1.3-6.0, P =.007). Conclusions: In this patient population, methicillin resistance was associated with a greater risk of death attributable to SA disease and to death from any cause. MRSA infections were more common among those with chronic illnesses. Optimal methods of prevention and treatment of healthcare-associated SA, particularly MRSA infections, are urgently needed. Community-Associated (CA) Methicillin-Resistant Staphylococcus aureus (MRSA) in Affected Households: Prevalence of Colonization and Incidence of Subsequent Infections J. M. Buck1, R. Gorwitz2, R. Lynfield1, K. Harriman3; 1Minnesota Department of Health, Saint Paul, MN, 2Centers for Disease Control and Prevention, Atlanta, GA, 3California Department of Public Health, Richmond, CA. Background: MRSA has emerged as a community pathogen over the last decade. Several reports indicate that CA-MRSA infections can occur among multiple household members (HHMs). We describe MRSA colonization prevalence and subsequent infection incidence among children with CAMRSA infections and their HHMs. Methods: MRSA infections in children <18 p =" 0.03)," p =" 0.03)."> 0.05). Conclusions: The prevalence of MRSA colonization in affected HHs did not decrease during the study period; over 20% of HHs had at least one colonized HHM one year after initial CP infection. Use of mupirocin did not appear to affect long term MRSA colonization or infection in HHs. Behavior modifications (e.g. not sharing personal items) may be more important in reducing MRSA transmission. Additional strategies to prevent CA-MRSA infection and transmission in HHs should be evaluated.

Detection of Community Acquired Methicillin Resistant Staphylococcus aureus
Associated with Nosocomial Infections

S. M. Tallent, D. M. Toney; Virginia Division of Consolidated Laboratory
Services, Richmond, VA.

Background: Staphylococcus aureus is a human commensal that has emerged as a significant
pathogen due to the production of a variety of virulence factors and acquisition of numerous antimicrobial resistant genes. Methicillin resistant S. aureus (MRSA) is an antimicrobial resistant strain traditionally associated with hospital infections, but is now increasingly associated with illness in typically healthy individuals outside healthcare facilities. Pulsed-field gel electrophoresis (PFGE) genotyping of staphylococcal isolates by the CDC categorized MRSA strains into two groups, community-acquired methicillin resistant S. aureus (CA-MRSA) and hospital-acquired methicillin resistant S. aureus (HAMRSA). The two groups clustered into ten lineages which were designated as pulsetypes USA100- USA1100. More recently, distinctions between HA-MRSA and CA-MRSA have become less apparent, presumably due to recombination events giving rise to new MRSA strains that differ from the USA pulsetypes. Methods: S. aureus isolates from previous hospital and community outbreaks occurring in
Virginia as early as 1997 were subjected to PFGE genotyping, generating a DNA fingerprint database at the Division of Consolidated Laboratory Services (DCLS), the Virginia state laboratory. Archived isolates from 2005-2007 (N=258) were compared to the prototype USA fingerprint patterns and classified based on pattern similarities. Clusters of isolates possessing >80% similarity to the USA pulsetypes were further evaluated. Results: Forty percent of the 258 MRSA isolates examined clustered with USA100, the most common HA-MRSA pulsetype. Of these strains, 23% were associated with community outbreaks not hospital infections based on epidemiologic investigations. In contrast, 22% of the 258 isolates clustered with USA300, the most common CA-MRSA pulsetype. Of these, 88% were previously determined to be
associated with nosocomial infections. Conclusions: This study has identified a subset of MRSA strains designated as outliers based on PFGE pulsetype patterns and epidemiology. Additional molecular characterization is ongoing to understand these findings, determine if this is a representative trend in Virginia and whether the most invasive form of MRSA has become endemic to Virginia’s healthcare facilities.

Board 7. Community-Associated Methicillin-Resistant Staphylococcus aureus
Infection Risk Factor Study

K. Como-Sabetti1, K. Harriman2, S. Fridkin3, R. Lynfield4; 1Minnesota Department of Health, Minneapolis, MN, 2California Department of Public Health, Richmond, CA, 3Centers for Disease Control and Prevention, Atlanta, GA, 4Minnesota Department of Health, Saint Paul, MN.

Background: Little is known about risk factors for methicillin-resistant Staphylococcus aureus (CA-MRSA) infection in non-outbreak settings. Methods: MN Department of Health initiated a hypothesis-generating CA-MRSA case control study in 2003. 150 patients with S. aureus infections, including both CA-MRSA and CA methicillinsensitive SA (MSSA), were identified by 3 sentinel labs. 2-3 age-group matched healthy community controls (CC) were identified by sequential digit dialing. Participants were interviewed about possible risk factors and an antibiotic history was obtained from healthcare providers. Univariate and multivariate conditional logistic regression were conducted using SAS for 3 separate analyses to avoid biased estimates: CA-MRSA cases vs. CA-MSSA cases, CAMRSA cases vs. CA-MRSA CCs, and CA-MSSA cases vs. CA-MSSA CCs.Results: 75 CA-MRSA and CA-MSSA cases and 438 CCs were enrolled. Antibiotic use in the prior 1-6 months (recent ABX) was more frequent among CAMRSA cases than CA-MSSA cases or CCs (33% vs. 17% vs. 14%). History of boils was infrequent (10% CA-MSSA, 1% CA-MSSA, 1% CCs). Race, education, income, household members per room, dog in the home, history of boils, and towel sharing were associated with CA-MRSA when compared to CA-MSSA or CA-MRSA CCs. Recent ABX and number of recent ABX courses were associated with CA-MRSA when compared to CA-MSSA cases (p=0.03;
OR=2.5, and p<0.01; OR=2.2 respectively) and persisted when compared to CA-MRSA CCs (p=0.05; OR=2.3, and p=0.02; OR=1.9 respectively), but were not associated with CA-MSSA cases compared to CA-MSSA CCs. After adjusting for socioeconomic factors, history of boils was associated with CA-MRSA compared to CA-MSSA (p=0.002; AOR=76.8) but not when compared to CA-MRSA CCs. Recent ABX and ABX courses were associated with CAMRSA compared to CA-MSSA (p=0.02, AOR=1.9, and p=0.01, AOR=2.2 respectively) and compared to CA-MRSA CCs (p=0.05, AOR=2.4, and p=0.02 and AOR = 1.9 respectively). Conclusions: In non-outbreak settings, antibiotic use and history of boils (which may be a proxy for prior CA-MRSA skin disease) appear to be risk factors for CAMRSA. Further investigation of antibiotic use and specific antibiotic classes is needed. Although not definitive, this study reinforces the importance of careful antibiotic stewardship.

Board 83. Critical or Fatal Illness Due to Community-associated Staphylococcus aureus (CA-SA) Infection, Minnesota (MN), 2005-2007

Page 121 of 262 L. Lesher1, J. Buck1, J. Bartkus1, S. Jawahir1, D. Boxrud1, K. Harriman2, R. Lynfield1; 1Minnesota Department of Health, Saint Paul, MN, 2California Department of Public Health, Richmond, CA.

Background: CA-SA infections have been associated with critical illness and death. Methods: Reporting for rapidly fatal or critical illness due to CA-SA infection, including isolate collection, was instituted statewide in MN in 2005. Cases were defined as previously healthy people who had fatal illness or ICU admission and no healthcareassociated (HA) MRSA risk factors per CDC definition, excluding hospitalization for birth. Isolates were characterized by pulsed-field gel electrophoresis (PFGE) and PCR for toxic shock syndrome toxin 1 (TSST1), Panton-Valentine leukocidin (PVL), and staphylococcal enterotoxin (SE) genes A, B, C, D. Results: 32 cases were reported January 2005 through October 2007; 21 (66%) methicillin-resistant SA (MRSA) and 11 (34%) methicillin-susceptible SA (MSSA) cases. 14 (67%) MRSA cases were male; median age, 17 years (12 days-88 years), and 5 (45%) MSSA cases were male; median age, 18 years (1 day-59 years). Two cases had multifocal infections; MRSA with pneumonia and septic arthritis; MSSA with meningitis, lumbar wound, pneumonia (fatal). Of MRSA cases, 11 (52%) had pneumonia (3 fatal), 5 (24%) had skin infections (4 bacteremic - 1 fatal; 1 necrotizing fasciitis - fatal), 2 (9%) had sepsis (1 fatal), 1 (5%) had meningitis, 1 (5%) had osteomyelitis. Of MSSA cases, 4 (36%) had pneumonia (2 fatal), 2 (18%) had skin infections with bacteremia, 2 (18%) had TSS, 1 (9%) had meningitis (fatal), 1 (9%) had sepsis. The median age of fatal cases was 58 years for MRSA, 27 years for MSSA. PFGE typing and toxin PCR were performed on 17 MRSA and 7 MSSA isolates. All MRSA isolates belonged to clonal groups associated with CAMRSA; USA300 (15), USA400 (1), USA1000 (1). MSSA isolates were found in groups associated with CA and HAMRSA; USA200 (1), USA400 (1), USA600 (2), USA700 (1), USA1000 (2). Among MRSA, toxin PCR found PVL in 14 USA300 isolates (2 fatal) and 1 USA400 (fatal), which also had SEA and SEC. Among MSSA, SEB was found in 1 USA1000 isolate (fatal) and TSST1 in 1 USA200 (clinical TSS), and 2 MSSA isolates from fatal cases were negative for all toxins tested. Conclusions: Most critical/fatal CA-SA reported cases were MRSA. A high fatality rate was observed in cases with meningitis or pneumonia. Fatal MRSA cases were older than MSSA cases. Most isolates contained toxins previously implicated in severe disease. Molecular

Epidemiology Board 109. Staphylococcal Cassette Chromosome mec (SCCmec) Characterization and Panton-Valentine Leukocidin Gene Occurrence for Methicillin-Resistant Staphylococcus aureus in Turkey, from 2003 to 2006

A. Kilic, A. Uskudar Guclu, Z. Senses, H. Aydogan, A. C. Basustaoglu; Gulhane Military Medical Academy, Ankara, TURKEY.

Background: Methicillin-resistant Staphylococcus aureus (MRSA) cause serious community-acquired and nosocomial diseases all over the world. Methods: We determined the SCCmec types and occurrence of the PVL gene by using TaqMan real-time PCR method, and correlated these with phenotypic antibiotic susceptibility patterns for MRSA strains collected from Gulhane Military Medical Academy Hospital (GMMAH) during four years study period. To our knowledge, this is the first report from Turkey of molecular SCCmec typing analysis of MRSA stains. From 2003 through 2006, a total of 385 clinical MRSA strains were collected in the Clinical Microbiology Laboratory at GMMAH were included in the study. Results: Overall, SCCmec types-I, II, II, IV, V, nontypeable and PVL occurrence were detected in 11 (2.8%), 3 (0.8%), 316 (82.1%), 20 (5.1%), 20 (5.1%), 15 (3.9%) and 5 (1.3%) isolates, respectively. A total of 330 (85.5%) were SCCmec-I/II/III, and of 40 (10.3%) were SCCmec-IV/V. SCCmec-I/II/III isolates were recovered more from serious infections in surgical departments especially having intensive care units than the SCCmec-IV/V isolates (?2=13.560, p<0.001). SCCmec-I/II/III MRSA strains were predominantly recovered from the blood stream as 53.0% (?2=6.016, p=0.014), while SCCmec-IV/V strains were predominantly isolated from skin, soft tissue and abscess as 55.0% (?2= 11.025, p<0.001). The PVL gene was detected in 10.0% of SCCmec- IV/V isolates in contrast to 0.3% in SCCmec-I/II/III (?2= 25.164, p<0.001). SCCmec-I/II/III MRSA strains were more resistant to clindamycin (?2=5.078, p=0.024), amoxicillin-clavulanate (?2=84.912, p<0.001), erythromycin (?2=4.651, p=0.031), gentamicin (?2=24.869, p<0.001), and rifampin (?2=18.878, p<0.001) than SCCmec-IV/V MRSA strains. Conclusions: These data indicate that SCCmec-III MRSA strains not to carrying PVL gene are the predominant MRSA strains in our hospital settings in Ankara, capital of Turkey. SCCmec-I/II/III MRSA strains may cause serious infections in surgical department especially having intensive care units.

Board 227. Staphylococcus aureus and Methicillin Resistant Staphylococcus aureus on surfaces in a University and a Jail Setting

M. Felkner1, K. Bartlett2, K. Andrews2, L. Field2, J. Taylor1, T. Baldwin1, J. Presley2, J. Duncan2, S. Newsome1; 1Texas Department of State Health Services, Austin, TX, 2The University of Texas at Austin, Austin, TX.

Background: Longtime pathogen Staphylococcus aureus has become more threatening with its evolution of antibiotic resistance, particularly the emergence of methicillin resistance outside health care settings. Commonly touched surfaces may harbor methicillin resistant S. aureus (MRSA) and be possible reservoirs of organisms facilitating disease transmission in the community. This study provides information regarding the presence of MRSA on commonly touched objects in both a university and a jail setting. Methods: University surface samples were obtained from bathrooms, common use areas, and recreational and sports facilities. Samples were collected at the jail from bathrooms, cells, common use areas, the clinic, laundry, and vehicles. Samples were collected using sterile, cotton-tipped swabs. Specimens were screened for S. aureus and MRSA using standard media. Susceptibility was determined using the ETest strip. Percentages of contaminated surfaces were calculated and chi-square comparisons were made between university and jail settings. Results: Seventeen (7.0%) of 244 university samples and 10 (7.5%) of 132 jail samples grew S. aureus. MRSA was recovered from 3 (1.2%) university samples, constituting 17.6% of S. aureus samples. Eight (6.1%) jail samples were MRSA, comprising 80% of jail S. aureus samples. The proportion of MRSA-contaminated surfaces and the ratio of MRSA to methicillin susceptible S. aureus were significantly greater at the jail that at the university (p<0.05). Conclusions: Our results indicate that environmental contamination with MRSA may be positively correlated with the carriage rate within the population. Page 191 of 262 Implementation of environmental sanitation should be of particular concern in populations with high MRSA nasal carriage rates.

Board 264. 30-Day and 180-Day Case Fatality Rates among Invasive Methicillin-Resistant Staphylococcus aureus Patients (Tennessee, 2004–2007)

K. R. Glenn, M. A. Kainer; Tennessee Department of Health, Nashville, TN.

Background: Tennessee had the second highest incidence of invasive MRSA (I-MRSA) of 10 EIP study sites in 2005, with an incidence of 53 per 100,000. The national in-hospital case-fatality was 17.8%. U.S. in-hospital mortality rate from I-MRSA was 6.3 per 100,000. We wanted to assess the 30-day and 180-day crude case-fatality (CFR) and mortality rates of I-MRSA and determine factors associated with death. Methods: Vital statistics data was available up to Oct. 31, 2007. We used data from the Active Bacterial Core (ABC) surveillance component of the Emerging Infections Program in Davidson County. Cases from Oct. 2004-Jul. 2007 were included for 30-day CFR/mortality rates. Cases from Oct. 2004-Apr. 2007 were included to determine 180-day CFR/mortality rates. We reviewed Tennessee vital statistic data to determine patient outcomes; we matched by name and birthdate. We

Page 208 of 262

calculated the number of days between the initial MRSA-positive culture and date of death recorded on death certificates for each matched case to determine the numerator for the 30- and 180-day CFR/mortality rates. Results: I-MRSA rates for 2004-2007 were 59.1 per 100,000. The 30-day I-MRSA mortality rate was 7.3; 180-day I-MRSA mortality rate was 9.9 per 100,000. Fifty-four of 192 deaths (28%) were identified from vital statistic records alone (i.e., occurred following discharge). The overall 30- and 180-day CFRs were 13.2% and 19.1%, respectively. Blood stream infections (BSI) accounted for 85% of I-MRSA. Patients with MRSA BSI had higher 30- and 180-day crude CFRs compared to patients with non-BSI I-MRSA (14.7% vs. 4.5% [relative risk {RR}= 3.3, 95% CI: 1.5-7.3] and 21.4% vs. 5.7%, [RR= 3.8, 95% CI: 1.8-7.9], respectively). 30-day CFRs were not statistically significant among Blacks and Whites (12.6% vs. 14.3%, respectively). Healthcare-associated I-MRSA had a higher 30- and 180-day CFR compared to community-associated MRSA (14.4% vs. 9% [RR= 1.7, 95% CI: 1.0-2.9] and 21.0% vs. 12.7%, [RR= 1.7, 95% CI: 1.1- 2.8] respectively). Conclusions: MRSA BSI is associated with much higher CFR than other IMRSA. Policy and practices aimed toward the reduction of I-MRSA rates in Tennessee are necessary to decrease the number of deaths annually associated with I-MRSA.

Board 268. Dissemination of Community-Associated Methicillin-Resistant Staphylococcus aureus CMRSA7 (USA400) in Northern Saskatchewan, Canada

J. Irvine1, B. Quinn1, D. Stockdale1, S. Woods2, M. Nsugngu2, P. Levett3, R. McDonald3, G. Golding4, G. Horsman3, M. Mulvey4, the Northern Antibiotic Resistance Partnership; 1Population Health Unit, LaRonge, SK, CANADA, 2Northern Inter-tribal Health Authority, Prince Albert, SK, CANADA, 3Saskatchewan Disease Control Laboratory, Regina, SK, CANADA, 4National Microbiology Laboratory, Winnipeg, MB, CANADA.

Background: Although the USA300 (CMRSA10) strain of community-associated methicillin-resistance (CAMRSA) is rapidly disseminating across North America, some reports have described the emergence of CA-MRSA in northern Canadian communities. This study examines the incidence and molecular epidemiology of CA-MRSA in Page 210 of 262 three of the most northerly Saskatchewan health regions. Methods: Surveillance was conducted over six years beginning in 2001 in three of the most northerly Saskatchewan health regions for all communities (on and offreserve). Specimens from clinical indications were collected from remote community health centers and small rural hospitals (<35 beds) and MRSA positive cases were reported to the respective health authorities. Cases with asymptomatic carriage were excluded. In order to calculate total CA-MRSA rates of recurrence, cases occurring more than 2 months of the preceding episode and / or at a different site, were considered a recurrent episode. Pulsed-field gel electrophoresis (PFGE) of SmaI digested genomic DNA and RT-PCR for the mecA, nuc, and PVL-encoding genes was used to characterize a subset of the isolates. Results: A total of 1,927 MRSA events in 1,409 individuals were reported over the study period with 99% being community-associated. Fifty-six percent (N=783) of the individuals were < 20 years of age, while the majority of their cases (80.8%) were skin and soft tissue infections. The annual rate of CA-MRSA distinct individuals reported in these health regions increased from 9 per 10,000 population in 2001 (range to 4-10 per 10,000) to 169 per 10,000 in 2006 (range 43-233 per 10,000). An annual periodicity was observed with the highest number of cases being reported during the third quarter (July-September). Of the CAMRSA cases, 15.1% of the individuals had at least one recurrent episode after 2 months. A subset of strains (N=192) were typed and 97.4% (N=187) were found to be Canadian PFGE epidemic type CMRSA7 (USA400) with 3 strains being CMRSA2 (USA100/800) and 2 strains being CMRSA10 (USA300). Conclusions: This report describes the rapid emergence of CA-MRSA in Northern Saskatchewan. The molecular epidemiology appears to be different from urban centers in southern Canada with the majority of cases being caused by CMRSA7 (USA400). Antimicrobial Resistance

Board 294. Daptomycin Resistance and hVISA Development in MRSA Endocarditis

M. Pastagia1, N. Casau-Schulhof1, S. G. Jenkins2, J. Jao2; 1Mount Sinai Hospital, New York, New York, NY, 2Mount Sinai Medical Center, New York, NY.

Background: Methicillin-resistant Staphylococcus aureus (MRSA) is a common etiology of endocarditis in hemodialysis patients. We present a patient without any prior hospitalizations or vancomycin usage within the past ten years who developed MRSA endocarditis with persistent bacteremia while on daptomycin therapy. She then became resistant to daptomycin while on therapy, and ultimately cleared her bacteremia only after valve replacement. We performed microbiological tests on her blood and valve isolates. Methods: We performed E-strip testing of the four blood isolates with MRSA bacteremia as well as the tissue heart valve after replacement with vancomycin, daptomycin, linezolid, and tigecycline E-strips to establish the MIC. These specimens were also tested for

Page 222 of 262

heterogeneously vancomycin intermediate Staphylococcus aureus (hVISA) via teicoplanin E-strips of 0.5 and 2 McFarland standards. Results: The initial positive blood culture with MRSA was shown to have a MIC to vancomycin of 6 and 3 for daptomycin. These numbers remained similar for the subsequent two positive blood cultures a few days later while she remained on daptomycin, renally dosed. The fourth positive blood culture nearly one week later while on daptomycin was found to have a vancomycin MIC of 6 and a daptomycin MIC of 4. The heart valve was subsequently replaced, and the MICs of the tissue valve to vancomycin was 3, and to daptomycin was 6. All of these isolates were then tested for hVISA via teicoplanin E-strip testing at 0.5 and 2 McFarland standards. This testing revealed MICs of 3 and 4 at 0.5 and 2 McFarland, respectively for the initial blood culture. The subsequent two blood cultures showed MICs of 6 and 8 respectively. By the fourth blood culture, the MICs were 12 and 8 respectively. Ultimately the tissue valve’s MICs to teicoplanin were tested, and found to be 12 and 16, respectively. Conclusions: It is quite uncommon for patients who have not been on prior vancomycin therapy extensively to develop resistance to daptomycin so quickly. Here, we present such a case and were able to demonstrate that this isolate became a heterogeneously vancomyin intermediate Staphylococcus aureus after nearly one week of daptomycin therapy. This transformation from a non-hVISA to an hVISA strain may be predictive of antibiotic failure in this case.

Board 295. Laboratory Analysis of Staphylococcus aureus in Florida: January 1, 2003 to December 31, 2005 with an Emphasis on Methicillin Resistance

S. K. Kolar1, R. Sanderson2, A. Sanchez-Anguiano1; 1University of South Florida, Tampa, FL, 2Florida Department of Health, Tampa, FL. Background: Methicillin resistance among S. aureus has been a concern in the healthcare setting. Recently, MRSA has emerged in the community setting. Methods: This cross-sectional study examines methicillin resistance among S. aureus laboratory isolates in an outpatient population in the state of Florida. The database included all S. aureus laboratory results from a large commercial laboratory from January 1, 2003 to December 31, 2005 provided to the Florida Department of Health. Results: There was a total of 61,596 isolates in the database with the number of isolates doubling each year. The percent of isolates that were methicillin resistant significantly increased each year from 35.1% in 2003 to 49.7% in 2005. Isolates from skin and soft tissue comprised 79.6% of the reported site of infections, of which 52.7% were methicillin resistant in 2005. Methicillin resistance varied by year, age group, gender, county, and region. There was little difference in methicillin resistance between males and females (49.0% and 50.2% in 2005). There was some variation between the age groups, the 21- 30 age group had the highest percentage of MRSA (51% in 2005) and the <1 age group the lowest (40.2% in 2005). Variation by region and county was noted with the western panhandle having the highest percentage of MRSA (62.5% in 2005) and the southwest region the lowest (41.7% in 2005). The percentage of MRSA isolates that were resistant to trimethoprim-sulfamethoxazole, gentamycin, and rifampin was less than three percent. Discussion: The percent of isolates that were methiclillin resistant significantly increased during the study period. The differences by age group and region of the state were larger and may be important to consider when evaluating a potential S. aureus infection. Resistance to non beta-lactam antibiotics remains low and these could be alternative for empiric antimicrobial therapy in the outpatient setting.

New or Rapid

Diagnostics Board 38.

Novel Method and Medium for Detecting and Identifying both Methicillin Susceptible (MSSA) and Methicillin resistant(MRSA) Staphylococcus aureus

S. C. Edberg; Yale-New Haven Hospital, New Haven, CT.

Background: Currently, to detect MSSA or MRSA two pathways are available. The first uses semi-selective culture media; incubation 18-24h, then a series of tests for identification; subculture to a mec A inducing medium for an additional 18 to 24h. Accordingly, considerable skilled labor and time are required. The second pathway utilizes specific genetic amplification of the mecA gene for MRSA, and another amplification for MSSA. Each is quite costly in materials and equipment, thus precluding its use from all but the largest hospitals. A novel specific method and medium for detection of (MSSA) and (MRSA) [AureusAlert®, Pilots Point LLC] (AA) is presented. It requires no skilled labor, determines the presence of S. aureus (SA) within 4h, and differentiates MSSA and MRSA in an additional 12- 16h, and costs 25% of PCR. Methods: The testing procedure first utilizes an enhanced plasma substrate. The specimen (e.g., nasal swab) is inoculated into this plasma substrate and incubated at 35C. If SA is present, in from 2 to 6 hours on average, a clot forms because of the detection of coagulase. Hence, the observation of the clot is Page 99 of 262 specific for the presence of SA.. The clot is then dissolved, freeing the SA. An aliquot from the liquefied clot is added to a culture medium that promotes the growth of SA and also has cefoxitin to ascertain methicillin resistance. After incubation (8-18 h), growth, as evidenced by a color change, is specific for MRSA; no color change indicates the presence of MSSA. A total of 60 MSSA and 60 MRSA from patient nasal cultures were constructed to determine minimum SA sensitivity. In addition, 50 ICU patient samples were tested and compared to the mannitol salt agar (MSA) procedure. Results: From the 60 MSSA constructed, all were positive in 5 h; 49 in 4 h; 38 in 3 h; and 26 in 2. From the 60 MRSA constructed, all were positive in 6 h; 54 in 5h; 49 in 4h; 36 in 3h, and 24 in 2h. Detection limit in all were 102-3. From the 50 patients, there were no false positives. MSA and AA both detected MSSA in 9; AA alone in 2. For MRSA, both MSA and MRSA detected 13, MSA alone detected 1, and AA alone detected 2. Conclusions: AureusAlert® offers the prospect for all sized institutions at risk for SA a low cost, rapid means to detect both MSSA and MRSA utilizing unskilled labor. Widespread clinical evaluation is warranted.

Transmission of Methicillin-Resistant Staphylococcus intermedius between Animals and Humans

E. van Duijkeren1, D. Houwers1, A. Schoormans1, M. Broekhuizen-Stins1, R. Ikawaty2, A. Fluit2, J. Wagenaar1; 1Faculty of Veterinary Medicine, Utrecht University, Utrecht, THE NETHERLANDS, Page 19 of 262 2Department of Medical Microbiology, University Medical Center Utrecht, Utrecht, THE NETHERLANDS.

Background: Staphylococcus intermedius is a commensal and a pathogen in dogs and cats, but is rarely isolated from humans. However, S. intermedius in humans has been associated with dog bite wounds, bacteraemia, pneumonia and ear infections. In the Netherlands, the prevalence of canine and feline infections with methicillin-resistant S. intermedius (MRSI) is increasing and therefore also the risk of their zoonotic transmission. Methods: At Utrecht University MRSI were cultured from infected surgical wounds of five dogs and one cat which had undergone surgery at the same veterinary clinic (clinic A). Samples were taken from the nose of the surgeon, from six technicians and from the nose and coat of two healthy dogs living at the clinic in order to identify the source. In addition, 22 environmental samples were taken from several sites at the clinic. S. intermedius was identified in these samples using standard techniques. Antimicrobial susceptibilities were determined by an agar diffusion method. The mecA gene was detected by PCR. The isolates were genotyped by PFGE using SmaI as restriction enzyme. Four epidemiologically unrelated MRSI isolates from patients at other veterinary clinics were also included. Results: MRSI was cultured from the nose of the surgeon, three technicians, one healthy dog and four environmental samples. The isolates were resistant against ampicillin, amoxicillin with clavulanic acid, cephalexin, ceftiofur, ceftazidime, enrofloxacin, gentamicin, kanamycin, chloramphenicol, lincomycin, clindamycin, tetracycline and trimethoprim/sulphamethoxazole and susceptible to fusidic acid and rifampicin. This was the same resistance pattern as the initial isolates from the six patients. All isolates were mecA positive by PCR. The PFGE profiles from the MRSI isolates from clinic A were all indistinguishable and differed from the profiles of the isolates from other clinics. Conclusions: Together, these data suggest transmission of MRSI between animals and humans. To our knowledge, this is the first report on the transmission of MRSI between humans and animals. People working at veterinary clinics should be aware of this risk for their own and their patients’ sake.

Methicillin-resistant Staphylococcus aureus (MRSA) Infections among Pets in Minnesota

J. B. Bender1, K. Coughlan1, K. Waters1, D. Boxrud2, K. Peterson3, J. Buck4; 1University of Minnesota, Veterinary Public Health, St. Paul, MN, 2Minnesota Department of Health, Public Health Laboratory, St. Paul, MN, 3University of Minnesota, Veterinary Medical Center, St. Paul, MN, 4Minnesota Department of Health, St. Paul, MN.

Background: Methicillin-resistant Staphylococcus aureus (MRSA) infections are increasingly being reported in dogs, horses, pigs, and cats. The zoonotic potential from these infections is unknown and requires further assessment. To document the occurrence among select animal populations, samples were collected from animals residing in a long-term care facility, pets of patients recently diagnosed with MRSA infection, and clinically ill animals presenting to a veterinary hospital. Methods: Nasal and rectal swabs were collected from asymptomatic animals in a long-term care facility and pets of patients recently diagnosed with MRSA. Culture-confirmed MRSA recovered from ill animals were identified through surveillance in a veterinary hospital. Collected isolates were sent to the Minnesota Department of Health for confirmation, antimicrobial susceptibility testing, and molecular subtyping. Results: Two of 11 resident Page 39 of 262 cats from the long-term care facility were identified with MRSA. All isolates were genotype USA100. MRSA was isolated from 2 of 28 asymptomatic pets of pet owners diagnosed with community-associated MRSA. Isolates from the 2 animals were genotype USA300. Since October 2003, MRSA has been identified in 18 refractory cases presented to the veterinary medical clinic. Isolates were obtained from 12 dogs, 5 cats, and 1 horse. Thirteen of 16 available isolates were genotype USA100 and the remaining 3 were genotype USA300. Nine of 12 interviewed family members of the infected pet were recently hospitalized or had on-going severe illnesses (i.e. chemotherapy), or were healthcare providers. Spread within the veterinary clinic was suspected from several case clusters supported by isolation of indistinguishable strains among case isolates. Conclusions: Pets with MRSA likely acquire their infection from their owners as demonstrated by the presence of common genotypes among the various populations. There is a need to re-enforce precautionary measures and hand hygiene to pet owners diagnosed with MRSA infection. Owner education should describe the potential risk of transmission from and/or to pets. Further research to quantify this household risk, the length of carriage in pets, and the potential treatment options is needed.

http://www.cdc.gov/eid/content/14/3/ICEID2008.pdf

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Fight to curtail antibiotics in animal feed

2008-01-29T09:03:00.000-08:00

Fight to curtail antibiotics in animal feed
Sabin Russell, Chronicle Medical Writer

Monday, January 28, 2008

Consumer advocates have been campaigning for years to curb the use of antibiotics in agriculture, citing studies that show that 70 percent of all U.S. antibiotics are administered in low doses - not to treat disease, but to promote the growth of pigs, sheep, chicken and cattle.

Low doses of antibiotics in animal feeds have been shown to boost the speed of food-to-muscle conversion by 5 percent, and can prevent the spread of disease in the tight quarters of modern factory farms.

But as early as 1963, British researchers tied the emergence of drug-resistant strains of salmonella in humans to antibiotics fed to cattle. Among the drugs routinely found in animal feed are erythromycin, penicillin and streptomycin. Critics warn that the use of antibiotics in feed at low dosages helps to breed resistant bacteria in the gut of farm animals - threatening the future of these drugs for use in animals or humans.

Major antibiotic classes such as tetracyclines and the Cipro-like fluoroquinolones have already been compromised, according to Keep Antibiotics Working, a coalition backed by environmental groups and the American Medical Association.

The stakes are high. The Union of Concerned Scientists calculated in 2001 that U.S. farm interests were using 24.6 million pounds of anti-microbials - almost 40 percent higher than industry estimates.

Ron Phillips, vice president of the Animal Health Institute, a Washington trade group for agricultural drugmakers, maintains that growth promotion accounts for only 4.5 percent of antibiotic consumption in agriculture. The rest are used to prevent, treat or control the spread of disease. "Antibiotics," he says, "are a net positive for both animal health and human health."

After antibiotics were banned from animal feed in Europe beginning in 1995, Phillips said, farmers there found they had to use more antibiotics to care for illnesses that cropped up in their livestock.

Keep Antibiotics Working nevertheless is pushing for a federal ban on antibiotics in feed. Introduced by Sens. Edward Kennedy, D-Mass, and Olympia Snow, R-Maine, the "Preservation of Antibiotics for Medical Treatment Act" would phase out in two years antibiotics deemed "important in human medicine."

In response to pressure from consumer groups, McDonald's declared four years ago its intention to phase out the purchase of meats from chicken and livestock fed the drugs to promote growth. The Food and Drug Administration in 2005 banned the use of a Cipro-like drug, Baytril, to treat bacterial infections in poultry, after drug-resistant strains of Campylobacter - a common food-poisoning organism - were found in chicken. Cases of Cipro-resistant Campylobacter were also rising in humans.

The FDA is considering an application for approval of the antibiotic cefquinome, a proposed veterinary drug that is similar to the human drug cefepime. In the fall of 2006, an FDA advisory committee recommended against approval.

"It was surprising what the committee did, because it was stacked with veterinarians and animal science people," said Stephen Roach, director of public health programs for Keep Antibiotics Working.

"The USDA is very reluctant to say that antibiotic use causes a problem, and the FDA has traditionally been in the middle. But I feel that in the last several years, they have been more accommodating to industry," said Roach.

A final decision on approving cefquinome is still pending.

E-mail Sabin Russell at srussell@sfchronicle.com.

http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2008/01/28/MNSTUGD8E.DTL

Public Health Service
Food and Drug Administration

Baltimore District Office
6000 Metro Drive
Suite 101
Baltimore, MD 21215-3215
Telephone: (410) 779-5454

FEI: 3000203759

January 16 , 2008

WARNING LETTER

08-BLT-03

CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. Francis H. Roderick
Old Carolina Farms
10802 Cook Brothers Road
Ijamsville, Maryland 21754

Dear Mr. Roderick:

An inspection of your dairy operation located at 10802 Cook Brothers Road, Ijamsville, Maryland, conducted by a representative of the U.S. Food and Drug Administration (FDA) between October 16, 2007, and November 27, 2007, confirmed that you offered a bob veal calf for sale for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)] and 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act) . The inspection also revealed that you caused the new animal drug, [redacted] (sulfamethazine) [redacted] to become unsafe under section 512(a) [21 U.S.C. § 360b(a)] of the Act and adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act. In addition, the inspection revealed that you provided a false guaranty, a prohibited act under section 301(h) of the Act [21 U.S.C. § 331(h)], You can find the Act and its associated regulations on the Internet through links on the FDA's web page at
www.fda.gov.

On or about July 25, 2007, you consigned a bob veal calf, identified with tag [redacted], for slaughter as food an [redacted]. On or about July 26, 2007, this animal was slaughtered at [redacted] United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of 131.89 parts per million (ppm) of sulfamethazine in the liver tissue and 179.88 ppm of sulfarnethazine in the muscle tissue of this animal. A tolerance of 0.1 ppm has been established for residues of sulfamethazine in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations, section 556.670 [21 C.F.R. 556.670]. The presence of this drug in these amounts in edible) tissues from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii)[(21 U.S.C. § 342(a)(2)(C)(ii)] of the Act.

Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. You lackS 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) [21 U.S.C. § 342(a)(4)] of the Act.

Furthermore, on or about April 9, 2001, you provided [redacted] with a signed certification, which states that you will not supply [redacted] with any livestock that is "adulterated within the meaning of the Federal Food (Drug] and Cosmetic Act (i.e., none of the cattle or other ruminants will have been fed any feed containing protein derived from mammalian tissues, e.g. meat and bone meal, as that term is defined in 21 C.F.R. 589.2000 and none of the livestock will have an illegal level of drug residues)." On July 25, 2007, you delivered to [redacted] a bob veal calf containing illegal levels of sulfamethazine residues. Providing such a false guaranty is a prohibited act under section 301(h) [21 U.S.C. § 331(h)) of the Act.

In addition, you adulterated [redacted] (sulfamethazine) [redacted] within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act when you failed to use the drug in conformance with its approved labeling. "Extralabel use," i.e., the actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling, is only permitted if the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. The extralabel use of approved veterinary or human drugs must comply with sections 512(a)(4) [21 U.S.C. § 360b(a)(4)] and 512(a)(5) [21 U.S.C. § 360b(a)(5)] of the Act and 21 C.F.R. Part 530. Our investigation found that your extralabel use of [redacted] (sulfamethazine) [redacted] failed to comply with these requirements. For example, you administered these [redacted] (sulfamethazine) [redacted] without following the withdrawal period set forth in the approved labeling and you did so without the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Furthermore, your extralabel use resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Because your extralabel use of this drug was not in compliance with 21 C.F.R. Part 530, the drug was unsafe under section 512(a) [21 U.S.C. § 360b(a)} of the Act and your use caused it to be adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act.

The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law. You should take prompt action to correct the above violations and to establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.

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

Your written response should be sent to Steven B. Barber, Compliance Officer, U.S. Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215. If you have any questions about this letter, please contact Mr. Barber at 410-779-5134.

Sincerely yours,

/S/

Kirk Sooter
Acting District Director

cc: Dr. David F. Vogt
USDA, APHIS, VS
1598 Whitehall Road, Suite A
Annapolis, Maryland 21401

FSIS District Office
5601 Sunnyside Avenue Suite 1-2288 B
Beltsville, Maryland 20705

[redacted]

[redacted]

http://www.fda.gov/foi/warning_letters/s6642c.htm

Public Health Service
Food and Drug Administration

New York District
300 Pearl Street, Suite 100
Buffalo, NY 14202

January 11, 2008

WARNING LETTER NYK 2008-05

CERTIFIED MAIL
RETURN RECEIPT REOUESTED

Aaron G. Poupore, Co-Owner/Herdsman
Papas Dairy, LLC
322 Wheeler Road
North Bangor, New York 12966

Dear Mr. Poupore:

An inspection of your dairy operation located at 322 Wheeler Road, North Bangor, New York, conducted by a representative of the U.S. Food and Drug Administration (FDA) on October 17-19, 2007, confirmed that you offered a cow for sale for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)] and 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act). The inspection also revealed that you caused the new animal drugs, ALBON® (sulfadimethoxine) boluses and penicillin G procaine, to become unsafe under section 512 [21 U.S.C. § 360b] of the Act and adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act. You can find the Act and its associated regulations on the Internet through links on FDA's web page at www.fda.gov.

On or about September 11, 2007, you consigned a cow identified with farm [redacted] for slaughter as food to [redacted] where it was picked up the next day by [redacted]. On or about September 13, 2007, this animal was slaughtered at [redacted] United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that cow identified the presence of 0.60 parts per million (ppm) of sulfadimethoxine in liver tissue and 0.41 ppm of sulfadimethoxine in muscle tissue. A tolerance of 0.1 ppm has been established for residues of sulfadimethoxine in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations, Section 556.640(21 C.F.R. 556.640). The presence of this drug in these amounts in the uncooked edible tissues of this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)] of the Act.

Our investigation also found that you hold animals under conditions that are so in adequate 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 complete treatment records. Food from animals held under such conditions is adulterated within the meaning ofsection402(a)(4)[21 U.S.C. §342(a)(4)] of the Act.

In addition, you adulterated Albon® sulfadimethoxine boluses and Penicillin G Procaine within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act when you failed to use these drugs in conformance with their approved labeling. "Extralabel use," i.e., the actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling, is only permitted if the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. The extralabel used of approved veterinary or human drugs must comply with sections 512(a)(4) [21 U.S.C. § 360b(a)(4)] and 512(a)(5) [21 U.S.C. § 360b(a)(5)] of the Act and 21 C.F.R. Part 530. Our investigation found that your extralabel use of Albon® sulfadimethoxine boluses and Penicillin G Procaine failed to comply with these requirements.

For example, you administered Albon® sulfadimethoxine without following the dosage level set forth in the approved labeling and you did so without the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Furthermore,your extralabel use resulted in an illegal residue, in violation of 21 C.F.R. 530.11(d). In addition, you administered IBA Penicillin G Procaine Injectable Suspension to cows on your farm without following the dosage level, route of administration, and duration of treatment set forth in the approved labeling, and you did so without the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Because your extralabel use of these drugs was not in compliance with 21 C.F.R. Part 530, the drugs were unsafe under section 512(a) [21 U.S.C. § 360b(a)] of the Act and your use caused them to be adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act.

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

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

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

Your written response should be sent to Edward W. Thomas,Director Compliance Branch, U.S. Food and Drug Administration, 300 Pearl Street, Suite 100, Buffalo, New York 14202. If you have any questions about this letter, please contact Mr. Thomas at (716) 541-0316

Sincerely yours,

/S/

Otto D. Vitillo
Director, New York District

http://www.fda.gov/foi/warning_letters/s6637c.htm

What Do We Feed to Food-Production Animals? A Review of Animal Feed
Ingredients and Their Potential Impacts on Human Health

Amy R. Sapkota,1,2 Lisa Y. Lefferts,1,3 Shawn McKenzie,1 and Polly Walker1
1Johns Hopkins Center for a Livable Future, Bloomberg School of Public
Health, Baltimore, Maryland, USA; 2Maryland Institute for
Applied Environmental Health, College of Health and Human Performance,
University of Maryland, College Park, Maryland, USA;
3Lisa Y. Lefferts Consulting, Nellysford, Virginia, USA

snip...

Table 1. Animal feed ingredients that are legally used in U.S. animal feeds

Animal

Rendered animal protein from Meat meal, meat meal tankage, meat and bone
meal, poultry meal, animal the slaughter of food by-product meal, dried
animal blood, blood meal, feather meal, egg-shell production animals and
other meal, hydrolyzed whole poultry, hydrolyzed hair, bone marrow, and
animal animals digest from dead, dying, diseased, or disabled animals
including deer and elk Animal waste Dried ruminant waste, dried swine waste,
dried poultry litter, and undried processed animal waste products

snip...

Conclusions

Food-animal production in the United States has changed markedly in the past
century, and these changes have paralleled major changes in animal feed
formulations. While this industrialized system of food-animal production may
result in increased production efficiencies, some of the changes in animal
feeding practices may result in unintended adverse health consequences for
consumers of animal-based food products. Currently, the use of animal feed
ingredients,
including rendered animal products, animal waste, antibiotics, metals, and
fats, could result in higher levels of bacteria, antibioticresistant
bacteria, prions, arsenic, and dioxinlike compounds in animals and resulting
animal-based food products intended for human consumption. Subsequent human
health effects among consumers could include increases in bacterial
infections (antibioticresistant and nonresistant) and increases in the risk
of developing chronic (often fatal) diseases
such as vCJD. Nevertheless, in spite of the wide range of potential human
health impacts that could result from animal feeding practices, there are
little data collected at the federal or state level concerning the amounts
of specific ingredients that are intentionally included in U.S. animal feed.
In addition, almost no biological or chemical testing is conducted on
complete U.S. animal feeds; insufficient testing is performed on retail meat
products; and human health effects data are not appropriately linked to this
information. These surveillance inadequacies make it difficult to conduct
rigorous epidemiologic studies and risk assessments
that could identify the extent to which specific human health risks are
ultimately associated with animal feeding practices. For example, as noted
above, there are insufficient data to determine whether other human
foodborne bacterial illnesses besides those caused by S. enterica serotype
Agona are associated with animal feeding practices. Likewise, there are
insufficient data to determine the percentage of antibiotic-resistant human
bacterial infections that are attributed to the nontherapeutic use of
antibiotics in animal feed. Moreover, little research has been conducted to
determine whether the use of organoarsenicals in animal feed, which can lead
to elevated levels of arsenic in meat products (Lasky et al. 2004),
contributes to increases in cancer risk. In order to address these research
gaps, the following principal actions are necessary within the United
States: a) implementation of a nationwide reporting system of the specific
amounts and types of feed ingredients of concern to public health that are
incorporated into animal feed, including antibiotics, arsenicals, rendered
animal products, fats, and animal waste; b) funding and development of
robust surveillance systems that monitor biological, chemical, and other
etiologic agents throughout the animal-based food-production chain “from
farm to fork” to human health outcomes; and c) increased communication and
collaboration among feed professionals, food-animal producers, and
veterinary and public health officials.

REFERENCES...snip...end

Sapkota et al.
668 VOLUME 115 NUMBER 5 May 2007 • Environmental Health Perspectives

http://www.pubmedcentral.nih.gov/picrender.fcgi?artid=1867957&blobtype=pdf

MRSA/VRSA

http://staphmrsa.blogspot.com/

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