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E. coli O157:H7 -- It's back, with a vengeance
Posted on December 2, 2007 by E. coli Attorney
Source of Article:

Not too long ago, I wondered if the beef industry had actually wised up, and was about to put me out of the business of representing the people they make sick. After a decade of nearly continuous outbreaks of deadly E. coli O157:H7, from Jack in the Box to ConAgra, the beef industry seemed to suddenly clean up its act. Earlier this year, the American Meat Institute claimed the incidence of E. coli in meat had dropped by 80 percent. That would have been good news for millions of Americans, especially young children, who are most vulnerable to food-borne illness. It would have been good news for the beef industry. And, believe it or not, it would have been good news to a lawyer who would prefer to never see another three-year-old child hooked up to a kidney dialysis machine. But, of course, it was too good to be true. In the last few months, E. coli O157:H7 has returned ? perhaps literally with a vengeance.
I spent the last few days looking at as many resources that track red meat ? primarily hamburger - recalls and the Illnesses stemming from them. Here is what I have found ? somewhat in chronological order. 2007 has had a substantial increase in the volume of recalls and illnesses in any year since 2002. By way of comparison, the amount of ground beef recalled in all of 2006 was 156,235 pounds in only 8 recalls. To date in 2007, over 29,248,167 pounds of meat have been recalled in 20 recalls. Well over 100 people have been sickened, some developing acute kidney failure ? many have contacted me. There are several E. coli-related deaths that may be linked to consumption of hamburger. Here is the 2007 list of recalls (some do not list pounds recalled):
1. Tyson Fresh Meats of Wallula, Washington shipped 16,743 pounds of E. coli suspect meat to distributors in Oregon, Washington, Idaho and Utah.
2. More than 100,000 pounds of frozen ground beef patties processed by a Merced company were recalled after three Little League teammates fell ill with E. coli. Richwood Meat Co. issued a recall of the year-old frozen beef, which was produced in late April and early May 2006. The Merced plant distributed meat in California, Arizona, Idaho, Oregon and Washington.
3. HFX Inc., recalled 259,230 lbs of beef products due to contamination with E. coli. USDA's Food Safety and Inspection Service and the Pennsylvania Department of Health found several illnesses tied to steak products produced by HFX Inc. for Hoss's Family Steak and Sea Restaurants, a chain based in Pennsylvania.
4. The Fresno County Health Department said that there were confirmed cases of E. coli in Fresno County. The Health Department has inspected the ¡°Meat Market¡± in Northwest Fresno. Meat from the company may have been served at several private parties where 20 guests later became sick. We represent several victims.
5. Davis Creek Meats of Michigan issued a beef recall because of E. coli contamination. The recall was for 129,000 pounds of beef products produced between March 1st and April 30th, and included the states of Illinois, Indiana, Iowa, Missouri, Wisconsin, Arkansas, Florida, Kansas, Kentucky, Michigan, Ohio, Pennsylvania, Tennessee, Virginia and West Virginia.
6. Lund¡¯s and Byerly¡¯s of Minnesota issued a ground beef recall prompted by the sickness of at least seven people who ate E. coli-contaminated ground beef produced by PM Beef Holdings and sold at Lund¡¯s and Byerly¡¯s stores in several states including Illinois, Iowa, Wisconsin, Arizona, Michigan, Minnesota, Ohio and Virginia. PM Beef, the meat company responsible for supplying tainted trim, withdrew nearly 117,500 pounds of beef it had shipped to eight states. We represent several victims.
7. United Food Group, LLC, expanded its June 3 and 6 recalls to include a total of approximately 5.7 million pounds of both fresh and frozen ground beef products produced between April 6 and April 20 (the largest recall since 2002) because it was contaminated with E. coli. An investigation carried out by the California Department of Health Services and the Colorado Department of Health, in coordination with the Centers for Disease Control and Prevention, preceded the recall of June 3. Illnesses occurred in Arizona (6), California (3), Colorado (2), Idaho (1), Utah (1) and Wyoming (1). Illness onset dates ranged between April 25 and May 18. We represent several victims.
8. Tyson Fresh Meats, Inc., recalled 40,440 pounds of ground beef products due to possible contamination with E. coli.
9. Custom Pack, Inc., recalled 5,920 pounds of ground beef and buffalo products because it may be contaminated with E. coli.
10. Abbott's Meat Inc., recalled 26,669 pounds of ground beef products because it may be contaminated with E. coli.
11. Nine people have gotten sick in Washington, Oregon and Idaho from E. coli contaminated Interstate Meat beef. Federal and state health officials issued a consumer alert after contaminated beef produced by Interstate Beef of Oregon sickened nine people. Interstate recalled 41,205 pounds (approximately 20 tons) of beef. We represent several victims.
12. Topps Meat Company expanded a recall of frozen hamburgers to 21.7 million pounds of patties because it was contaminated with a deadly type of E. coli, making it the second-largest ground beef recall in U.S. history. The largest ground beef recall in U.S. history was the 1997 Hudson Foods Company recall of 25 million pounds of ground beef. The third largest was the ConAgra Foods recall of 2002, which covered 19.7 million pounds of ground beef. The Centers for Disease Control and Prevention had identified 40 cases of E. coli in eight states. While this is the first recall in Topps' 65-year history, it is not the first time the company has had problems with E. coli. In 2005, a 9-year-old girl in Glenmont, N.Y., went into kidney failure after being infected with bacteria linked to a Topps beef patty. Ill persons reside in 8 states - Connecticut (2), Florida (1), Indiana (1), Maine (1), New Jersey (9), New York (13), Ohio (1), and Pennsylvania (12). We represent several victims.
13. Impero Food and Meats, Inc., recalled 65 pounds of ground beef products because it may be contaminated with E. coli bacteria. The company's president said the meat was distributed to five pizza restaurants in the Maryland area.
14. Fresh Brands Distributing Inc., recalled ground beef products sold by some of its Piggly Wiggly stores in Illinois after E. coli infections in two people may have been associated with beef bought in Wisconsin, the company said. Sheboygan-based Fresh Brands operates Piggly Wiggly stores throughout Wisconsin and in Antioch, Galena, Grayslake and Zion, Illinois.
15. Fairbank Reconstruction Corp., doing business as Fairbank Farms recalled 884 pounds of ground beef products because it may be contaminated with E. coli.
16. Del-Mar Provision Co., Inc., recalled 50 pounds of ground beef products because it may be contaminated with E. coli.
17. Arko Veal Co., recalled 1,900 pounds of ground beef products because it may be contaminated with E. coli.
18. J & B Meats Corporation Inc., recalled 173,554 pounds of frozen ground beef products because it may be contaminated with E. coli.
19. Cargill Meat Solutions Corporation recalled 845,000 pounds of frozen ground beef patties produced at its Butler, Wisconsin location because it was contaminated with E. coli. A search through Health Department websites and news has shown at least 13 people ill, and probably 14, 3 still hospitalized - 2 still in critical condition. We represent several victims.
20. American Foods Group, LLC (AFG), recalled 95,927 pounds of various coarse and fine ground beef products because it was contaminated with E. coli. The problem was discovered through an investigation into two illnesses that was initiated by the Illinois Department of Public Health. A death may be linked to the product in Kentucky.
I expect to hear that the above is just better reporting - tell that to the families and the kids. I have posted twice on the "uptick" in E. coli related outbreaks - See 1 and 2 - more to follow. Also read today's article from USA Today, "Most recalled meat is never recovered, likely is eaten."
As I have said before, "Safe Food in the US is a Train Wreck."

Protecting the nation's food supply
By Andrew C. von Eschenbach, M.D.
Source of Article:
The U.S. Food and Drug Administration takes very seriously its responsibility for ensuring the safety and defense of America's food supply as part of our mission to protect the public health. It is a huge job. FDA, which is responsible for the safety of everything we eat except for meat, poultry and some egg products, each year oversees domestic food worth $417 billion and imported food worth $49 billion.J
It is a job that has become increasingly complex. Consumers expect a wide variety of fresh fruits and vegetables to be available the year around, whether or not they are in season in the United States. Processed food and food ingredients arrive in our country from around the world and new production methods and techniques present additional challenges.
Recent recalls of peanut butter, fresh bagged spinach and pet food illustrate the potential difficulties. Although the FDA has a proud history of protecting Americans from unsafe food, it has become clear that our food safety system needs to be improved.JJ
That is why FDA recently unveiled its Food Protection Plan to bolster the safety and defense of America's food supply. This plan is science-based and comprehensive, focusing on the safety and defense of food throughout its entire journey from farm to family feast. It is also integrated and strategic, weaving together its three interlocking and essential features: prevention, intervention, and response. It will make our good food safety system even better.
The plan contains specific measures designed to prevent problems before they occur, and it proposes ways to intervene at critical points in the food supply chain, whether the food is produced here or abroad. It also details innovative ways to protect our food supply by monitoring and testing food at vulnerable points along the production chain. And, because even the best system is not perfect, this Food Protection Plan strengthens FDA's proven ability to respond promptly and effectively when we detect problems.
Safeguarding our food supply is much more than a major responsibility. It goes to the heart of our agency's mission of promoting and protecting the public health. In the months ahead, FDA will carry out the strategic and legislative proposals of this new Food Protection Plan. I am confident our new plan will ensure that the U.S. food supply continues to be one of the world's safest.
Andrew C. von Eschenbach, M.D.
Commissioner of Food and Drugs

Escherichia coli O157:H7 in Feral Swine near Spinach Fields and Cattle, Central California Coast1
Michele T. Jay,*¢Ó Michael Cooley,¢Ô Diana Carychao,¢Ô Gerald W. Wiscomb,¡× Richard A. Sweitzer,¢Ò Leta Crawford-Miksza,* Jeff A. Farrar,# David K. Lau,** Janice O'Connell,* Anne Millington,# Roderick V. Asmundson,** Edward R. Atwill,¢Ó and Robert E. Mandrell¢Ô
*California Department of Public Health, Richmond, California, USA; ¢ÓUniversity of California, Davis, California, USA; ¢ÔUS Department of Agriculture, Albany, California, USA; ¡×US Department of Agriculture, Sacramento, California, USA; ¢ÒUniversity of North Dakota, Grand Forks, North Dakota, USA; #California Department of Public Health, Sacramento, California, USA; and **US Food and Drug Administration, Alameda, California, USA
Source of Article:
Suggested citation for this article:

We investigated involvement of feral swine in contamination of agricultural fields and surface waterways with Escherichia coli O157:H7 after a nationwide outbreak traced to bagged spinach from California. Isolates from feral swine, cattle, surface water, sediment, and soil at 1 ranch were matched to the outbreak strain.

Recent experimental and epidemiologic studies suggest that domestic pigs are biologically competent hosts and a potential reservoir of Escherichia coli O157:H7 (1,2). Cattle are considered the primary reservoir of E. coli O157, but fecal shedding by other domestic livestock and wildlife has been described (3,4). E. coli O157 was isolated from a wild boar in Sweden, but there is limited information on its occurrence in feral swine in the United States (5). We report findings from an environmental and laboratory investigation after a nationwide spinach-associated outbreak of E. coli O157 in which the outbreak strain was isolated from feral swine and other environmental samples.

The Study
In September 2006, an outbreak of E. coli O157 was linked to consumption of fresh, bagged, baby spinach, with 26 states and Canada reporting 205 cases of illness and 3 deaths (6). Contaminated product was traced to 1 production date (August 15, 2006) at 1 processing plant and fields located on 4 ranches on the central California coast (7). The outbreak strain was isolated initially from cattle feces collected on September 27, 2006, ?1 mile from an implicated spinach field on a ranch (ranch A) where numerous free-roaming feral swine were observed. We investigated potential involvement of feral swine in E. coli O157 contamination of spinach fields and surface waterways.

Feral swine were live-captured in traps or hunted and humanely killed during October?November 2006. Two feral swine corral traps were placed 1.4 km apart, and 1.7 km (trap 1) and 1.2 km (trap 2), respectively, from the implicated spinach field (Figure 1). Photographs from digital infrared remote-sensing cameras (Recon Outdoors, Huntsville, AL, USA) were used in combination with sightings and live-capture to ascertain the minimum number of individual feral swine present on the ranch (8). The average population density was calculated on the basis of an estimate of the area sampled by both traps and the estimated mean home range (1.8 km) for feral swine in mainland California by using ArcView version 9.2 (Environmental Systems Research Institute, Redlands, CA, USA) (8).

Colonic fecal samples were collected from 40 feral swine (31 live-captured, 9 hunted); buccal swabs, rectal-anal swabs, and tonsils were analyzed from a subset of 8 animals (Table 1). Additionally, feces from domestic animals (cattle, dog, goat, horse, sheep) and wildlife (bird, coyote, deer, feral swine), surface water and sediment, soil, and well/irrigation water were analyzed. E. coli O157 was cultured by using an extended enrichment?immunomagnetic separation protocol (9,10). PCR analysis was used to confirm the presence of E. coli O157 and virulence factors (9,10). Genotypes of isolates from environmental samples were compared by using 10-loci multilocus variable number tandem repeat analysis (MLVA) and pulsed-field gel electrophoresis (PFGE) after digestion with XbaI and BlnI by using the PulseNet protocol (10?13).

E. coli O157 was cultured from 45 (13.4%) of 335 samples, including cattle and feral swine feces, feral swine colonic feces from necropsy, surface water and sediment, and pasture soil (Table 1). The eaeA, hlyA, and stx2 genes were present in all strains, and the stx1 gene was found in only 1 sample (subtype 5; Table 2, Figure 2). Isolates from 28 environmental samples at ranch A were indistinguishable from the major spinach-related outbreak strain by PFGE (Table 1). In contrast, E. coli O157 isolates from 3 other ranches implicated by traceback did not match the outbreak strain. Molecular typing by MLVA provided higher resolution discrimination between environmental strains (Figure 2). Three major MLVA clusters from ranch A and the surrounding watershed were identified. The cluster containing the outbreak strain (subtype E) is shown in Figure 2, and 16 other highly related subtypes were indistinguishable by PFGE (Table 2).

Ranch A is located in the central coast foothills of San Benito County, where the dominant habitat is coastal oak woodland interspersed with dense riparian vegetation near seasonal waterways (Figure 1). Approximately 2,000 range cattle were grazed on the ranch. Spinach and other leafy green vegetables were grown on a leased portion of the property that was separated from cattle pastures by wire mesh fence. Well water was used for irrigation. No evidence of cattle manure?based fertilizer application, runoff from cattle pastures, or flooding from surface waterways (based on topography) onto the implicated spinach field was found during the investigation (7).

Feral swine were the most abundant wildlife observed on ranch A, and evidence of intrusion, including tracks, rooting, or feces in crop fields and adjacent vineyards, was documented (Figure 1). Birds, black-tailed deer, cottontail rabbits, coyotes, and ground squirrels also were observed, but the population density of these species appeared lower, and their activity was confined mostly to rangeland areas according to visual observations. Swine visited the traps almost continuously from dusk until dawn with peak activity between 5:00 pm and midnight. An average of 3.6 swine/trap/night were live-captured. The estimated population density was 4.6 swine/km2 (95% confidence interval [CI] 3.8?5.9), and the actual number of feral swine on ranch A was estimated to be 149 animals (95% CI 124?192) (Figure 1). Feral swine used livestock rangelands and gained access to adjacent crop fields through gaps formed at the base of the fence by erosion and rooting. Cattle and feral swine had access to and congregated at surface waterways on the ranch (Figure 1).

We describe the first, to our knowledge, isolation of E. coli O157 from feral swine in the United States. The percentage of specimens positive for E. coli O157 among feral swine (14.9%) and cattle (33.8%) and the density (4.6 swine/km2) were high compared with results of previous ecologic studies (Table 1) (2?5,8,14,15). Molecular typing of isolates by PFGE and MLVA showed possible dissemination and persistence of the outbreak strain in multiple environmental samples as long as 3 months after the outbreak (Tables 1, 2). MLVA is more reproducible than PFGE and better at discriminating between closely related E. coli O157 isolates (10,12,13). Recovery of related E. coli O157 subtypes by both methods suggested swine-to-swine transmission, interspecies transmission between cattle and swine, or a common source of exposure such as water or soil (Table 2, Figure 2).

Mechanisms of in-field contamination of leafy greens for this and previous outbreaks remain unclear, but hypotheses have emerged. A relatively high density of feral swine near cattle and spinach fields could represent a risk factor for E. coli O157 contamination. Wildlife may be sentinels for E. coli O157 in the produce production environment, or they may be vectors involved in the contamination of plants directly by fecal deposition or indirectly by fecal contamination of surface waterways or soil. Notably, baby spinach is harvested with a lawn mower?like machine that could pick up fecal deposits in the field and thereby contaminate large volumes of product during processing. Fecal loading of surface waterways by livestock and wildlife with subsequent contamination of wells used for irrigation represents another possible route of transmission to plants in the field. Although E. coli O157 was not detected in irrigation water, older agriculture wells at ranch A appeared vulnerable to contamination by surface water (R. Gelting, pers. comm.). Unrecognized environmental and management practices during preharvest and postharvest processing also could have contributed to amplification and dissemination of E. coli O157 in raw spinach.

In summary, E. coli O157 contamination of spinach and other leafy greens is likely a multifactorial process. Additional research is needed to develop and implement effective risk assessment and management practices. For example, studies are needed to determine colonization potential of and levels of fecal shedding by feral swine, and the importance of interspecies transmission to other vertebrate or invertebrate (e.g., flies) populations near agricultural fields.

We thank Richard Gelting, CDC, and the members of the California Food Emergency Response Team, a joint emergency response team of the California Department of Public Health and the US Food and Drug Administration, for their work on the environmental investigation. We also are grateful to the growers, ranchers, and property owners for their cooperation during this study.

Portions of this work were supported by a grant from US Department of Agriculture Cooperative State Research, Education, and Extension Service Section 32.1 (project no. 2006-01240) and Agricultural Research Service Projects 5325-42000-044 and -45.

Dr Jay is a research scientist at the Food and Drug Laboratory Branch at the California Department of Public Health and an affiliate scientist at the Western Institute of Food Safety and Security, University of California, Davis. Her research interests include the molecular epidemiology of zoonotic pathogens and relationships to vertebrate population dynamics and the environment.

Cornick NA, Helgerson AF. Transmission and infectious dose of Escherichia coli O157:H7 in swine. Appl Environ Microbiol. 2004;70:5331?5.
Feder I, Wallace FM, Gray JT, Fratamico P, Fedorka-Cray PJ, Pearce RA, et al. Isolation of Escherichia coli O157:H7 from intact colon fecal samples of swine. Emerg Infect Dis. 2003;9:380?3.
Rice DH, Hancock DD, Besser TE. Faecal culture of wild animals for Escherichia coli O157:H7. Vet Rec. 2003;152:82?3.
Sargeant JM, Hafer DJ, Gillespie JR, Oberst RD, Flood SJ. Prevalence of Escherichia coli O157:H7 in white-tailed deer sharing rangeland with cattle. J Am Vet Med Assoc. 1999;215:792?4.
Wahlstrom H, Tysen E, Olsson-Engvall E, Brandstrom B, Eriksson E, Morner T, et al. Survey of Campylobacter species, VTEC O157 and Salmonella species in Swedish wildlife. Vet Rec. 2003;153:74?80.
Centers for Disease Control and Prevention. Ongoing multistate outbreak of Escherichia coli serotype O157:H7 infections associated with consumption of fresh spinach?United States, September 2006. MMWR Morb Mortal Wkly Rep. 2006;55:1045?6.
California Department of Health Services and US Food and Drug Administration. Investigation of an Escherichia coli O157:H7 outbreak associated with Dole pre-packaged spinach. 2007;1?50 [cited 2007 Apr 17]. Available from
Sweitzer RA, Gardner IA, van Vuren D, Boyce WM, Waithman JD. Estimating sizes of wild pig populations in the north and central coast regions of California. Journal of Wildlife Management. 2000;64:531?43.
Himathongkham S, Dodd ML, Yee JK, Lau DK, Bryant RG, Badoiu AS, et al. Optimal enrichment conditions and recirculating immunomagnetic separation (RIMS) for enhanced detection and recovery of low levels of Escherichia coli O157:H7 from fresh leafy produce and surface water. J Food Prot. 2007;70. In press.
Cooley M, Carychao D, Crawford-Miksza L, Jay MT, Myers C, Rose C, et al. Incidence and tracking of Escherichia coli O157:H7 in a major produce production region in California. PLoS ONE. 2007;2:e1159.
Ribot EM, Fair MA, Gautom DN, Cameron SB, Hunter B, Swaminathan B, et al. Standardization of pulsed-field gel electrophoresis protocols for the subtyping of Escherichia coli O157:H7, Salmonella, and Shigella for PulseNet. Foodborne Pathog Dis. 2006;3:59?67.
Hyytia-Trees E, Smole SC, Fields PA, Swaminathan B, Ribot EM. Second generation subtyping: a proposed PulseNet protocol for multiple-locus variable-number tandem repeat analysis of Shiga toxin-producing Escherichia coli O157 (STEC O157). Foodborne Pathog Dis. 2006;3:118?31.
Keys C, Kemper S, Keim P. Highly diverse variable number tandem repeat loci in the E. coli O157:H7 and O55:H7 genomes for high-resolution molecular typing. J Appl Microbiol. 2005;98:928?40.
Atwill ER, Sweitzer RA, Pereira MG, Gardner IA, van Vuren D, Boyce WM. Prevalence of and associated risk factors for shedding Cryptosporidium parvum oocysts and Giardia cysts within feral pig populations in California. Appl Environ Microbiol. 1997;63:3946?9.
Waithman JD, Sweitzer RA, Van Vuren D, Drew JD, Brinkhaus AJ, Gardner IA, et al. Range expansion, population sizes, and management of wild pigs in California. Journal of Wildlife Management. 1999;63:298?308.

1This work was presented in part as a poster at the 107th General Meeting of the American Society for Microbiology, Toronto, Ontario, Canada, May 24, 2007.

Humans not the major target of Shiga toxin
They're simply caught in crossfire 3-Dec-2007
Source of Article:
Washington, D.C. -- If you¡¯ve survived Shiga toxin and the after-effects of food poisoning, you may have been the innocent victim of a battle for survival between predator and prey.
Bacteria that carry a virus (a bacteriophage) that packs the Shiga toxin gene (Stx) may depend on it for protection from bacterial predators like the ciliated protozoan Tetrahymena. This is small comfort if you¡¯ve just consumed that
Food poisoning victims -- as a result, for example, of consuming Shiga-packing E.coli in a contaminated bag of spinach -- have always had the cold comfort of being told that not all common bacteria make humans extremely sick, only the strains that have integrated the Shiga gene into their DNA. These bacteria can produce large amounts of the Shiga toxin and release it into the surrounding environment.
Leaving sick humans aside for a moment, Gerald Koudelka, Todd Hennessey, and colleagues from the University at Buffalo in Amherst, New York, wondered what evolutionary advantage the bacteria would derive from carrying around such a prickly viral hitchhiker. They hypothesized that the Stx gene might give the bacterial host an equalizer against bacterial predators.
¡°Humans may not be the major target of this toxin,¡± explains Koudelka. ¡°Instead, they might be simply caught in the cross-fire in this ancient battle between prey and predators.¡±
To test their hypothesis, the researchers grew Tetrahymena with an E. coli strain (EDL933) that carries the Stx gene. It worked, at least, for the EDL933 that grew successfully in co-cultures with Tetrahymena. In this hostile environment, it was the predator, Tetrahymena, that was killed by the bacteria¡¯s Shiga toxin. An E. coli strain (W3110) lacking Stx did poorly with Tetrahymena as roommates. The Tetrahymena had them for lunch.
The Shiga toxin kills by binding to a receptor on the surface of Tetrahymena. Adding protein subunits that block toxin binding to the protozoan predator prevented killing by Shiga toxin. Humans have the same surface receptor for Shiga toxin as do Tetrahymena, which gives biologists and produce packers a close interest in the deadly duel between Tetrahymena and Shiga-packing E. coli.
The Koudelka and Hennessey labs are continuing to characterize the route of Shiga toxin entry into the cytoplasm of Tetrahymena, its mode of killing, and the ability of Tetrahymena to develop resistance to Shiga toxin. The protozoan might make a model cellular system for Shiga detoxification, which one day might relieve some of the stress around the salad bar, say Koudelka and Hennessey.

FDA lacks resources for adequate food regulation
By Laura Crowley
Source of Article:

12/3/2007 - Under-funding at the Food and Drink Administration (FDA) jeopardizes food safety and innovation, according to a report presented today, which suggests the formation of a new science body.
The Report of the Subcommittee on Science and Technology is a year-long review that attributed the regulatory board's shortfalls in supporting new technologies and ensuring food safety to a failure to increase resources to meet soaring demands.
The report states: "Crisis management in FDA's two food safety centers¡¦ has drawn attention and resources away from FDA's ability to develop the science base and infrastructure needed to efficiently support innovation in the food industry, provide effective routine surveillance, and conduct emergency outbreak investigation activities to protect food."
According to the report, the FDA cannot adequately monitor development of food and medical products because it is unable to keep up with scientific and technological advances.
Rapid developments in areas such as nanotechnology are exceeding the capacity of current FDA science capabilities to provide sufficient safety supervision.
This compromises public health, as the agency cannot effectively regulate products built on emerging science, and also restricts the Agency's ability to support innovation in the industries and markets that it regulates, including new food ingredients.
The report suggests the formation of a new department, possibly called the Incubator for Innovation in Regulatory and Information Science (IIRIS), to liaise with groups involved in the new science programs.
Despite crisis management diverting attention from advances in the food sector, safety procedures are also vulnerable due to lack of resources, says the report.
During the past 35 years, FDA funding for the inspection of the American food supply has decreased, forcing the FDA to impose a 78 per cent reduction in food inspections. This comes at a time when the food industry has been rapidly expanding and importation has increased.
With more food products and ingredients arriving from China, concerns have arisen over their lack of traceability. This is ever more worrying if the FDA lacks the resources to complete its own checks on the imports.
The FDA estimates it inspects food manufacturers only once every 10 years. The agency conducts no inspections on retail food establishments or on food-producing farms.
Previous reports by FDA advisory boards have voiced similar concerns, according to the report. Food regulations and inspections are vital throughout the industry, from the field to the shelves. Failures can affect the entire food supply chain.
As well as insufficient inspections, the report says the FDA has been slow to respond to outbreaks and needs to develop and keep pace with the new regulatory science needed to prevent future problems arising.
When Bovine Spongiform Encephalopathy (BSE) appeared in Europe, the FDA was denied the funds to bring the feed industry into rapid compliance with the new feed regulations, and so the disease spread to the US. This meant beef exports were cut off and American producers suffered multibillion dollar losses.
The report considers the FDA is failing in its safety mission because of an insufficient scientific workforce, infrastructure and computer system as well as increases in FDA mandates, the challenges of globalization, and an increase in scientific demands.
The FDA is an agency if the US Department of Health and Human Services and is responsible for the safety regulation of most types of foods and dietary supplements. Its federal budget request for 2008 totaled $2.1bn, a $105.8m increase from 2007.

Risk Assesment of the Public Health Impact from Listeria monocytogenes in Soft-Ripened Cheese: Request for Comments

Banquet Pot Pie Recall: ConAgra Customer Service Pathetic
December 1, 2007. By Jane Mundy
Source of Article:
Huntsville, AL: "What right does ConAgra have to tell me whether or not we had food poisoning?" says Ruth Gordon. "My daughter and I were severely ill for a week after we ate their Banquet turkey pot pies and all they are offering is a refund."
On October 4th, Gordon (not her real name) and her daughter shopped at their local grocery store and stocked up on turkey pot pies. "My daughter is a freshman at college so she is busy and we eat them through the week if we are too tired to cook," says Gordon. "Between the two of us, we go through about 12 a week.
"We had a few for dinner on Friday and on Saturday we had a few more. (I can eat two at a time). On Saturday evening my daughter was complaining of nausea and headache so she went to bed early. The next morning she woke up around 4am throwing up and had diarrhea. About 7am, I also felt sick and had a slight headache. 'Maybe we came down with a virus', I said to her.
My daughter thought if she ate something she might feel better. So we threw a few more pies in the oven, just before we got ready to go to church. She sings in the youth choir and I could tell she was sick-- she was white as a ghost, standing there in church. 'Mama, my stomach is hurting bad, I just want to go home,' she said.
By that time, I started getting diarrhea really bad. I drove to Wal-Mart and bought two big bottles of Pepto Bismal, along with some 7-up and orange juice. That night she was so bad her shoulders hurt and her joints ached all the way down to her ankles. We'd never had food poisoning before so I had no idea what the symptoms were.
A few days later, we heard about the pot pie recall. I was driving in my car and heard it on the radio. 'Listen up everybody', the announcer said. ' As much as we all love pot pies, you've got to come to a halt eating them. There's been a pot pie recall - Banquet has salmonella.'
Soon as I got to work, I went online and saw that ConAgra had recalled Banquet chicken and turkey pot pies. I didn't panic but said 'Ohmigod, we had food poisoning,' to my co-workers. I had been treating us like we had a virus. I said to my daughter, if that was food poisoning, I don't ever want to have it again. I should have known better because a virus can't attack you that bad.
We had four pies left. I looked in my fridge and the numbers on the boxes were on their recall list. Then I called the 1-800 number listed on the company website. When I called, they had to verify some information from the serial numbers and they asked where and when I bought them. Then they told me to take them back to the store for a refund.
'Wait a minute M'am,' I said. 'My daughter has been sick for over a week and all you can tell me is to take them back to the store? You mean we can't file some claim for sickness?'
'You mean pain and suffering? Well I can take your name and number and turn this over to our claims department. Someone will get in touch with you,' she said.
I asked her when that would be. She didn't know because they had a lot of claims ahead of me. And they were going to return calls in the order they received them. This was Saturday morning, October 13th.
I gave them a week. On October 20th I called back. A customer service rep said the reason we weren't called back was that pain was not a symptom of food poisoning.
'What do you mean?' I said.
'Well, y'all said you had pain in knee joints,' she replied.
According to their website pain was a symptom but she said pain in joints does not count!
Well if that is the case, I will be calling an attorney and let them know how many pot pies we have left and how my daughter and I were sick the whole week,' I said. 'And I'll see what the attorneys say about symptoms of food poisoning.'
She told me to hold the line.
A few minutes later, she asked me to give her the numbers again. Apparently the numbers I gave her were not right. She wanted the barcode numbers, not the serial numbers. She said they wanted the 310 numbers and I didn't give those correct numbers. But they were right there on the box. The woman on the 13th told me that she wanted the P9 numbers on the box - a long strip of numbers that ends with P9.
'I could have given those numbers to the lady last week,' I told her.
Then Mr. Jones called and said he was following up on my complaint. I had to describe our symptoms again. He told us to throw the pot pies away, mail the barcode to ConAgra and they would reimburse us for the cost of the pot pies.
'You're talking like the lady last week,' I said. 'What about pain and suffering?'
'Well, if you feel like you need to be compensated, you have to mail us more information and explain why you should be compensated,' said Mr. Jones.
I went back online and put my information on your complaint page like many other victims did and now the lawyers are talking to me about our case. My lawyer told me not to speak to Mr. Jones again. If he calls back, I have to tell him that I have retained an attorney. I am done with talking to ConAgra."

Pot Pie Salmonella Legal Help
If you or a loved one has suffered from salmonella poisoning after eating a Banquet Pot Pie or chicken nuggets, please contact a lawyer involved in a possible [Pot Pie Salmonella Lawsuit] who will review your case at no cost or obligation.:

Food Safety and Quality Related Job Openings
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EC Approves ¢æ187 Million to Fight Animal Diseases in 2008
Source of Article:
EU - The European Commission has approved a financial package of ¢æ186.57 million to support programmes to eradicate, control and monitor animal diseases in 2008, including Salmonella in Poultry and BSE.
For the first time, for some diseases like rabies, multi-annual programmes lasting from two to five years have also been approved, in order to ensure a more efficient and effective achievement of the objectives of those programmes.
The 197 annual or multi-annual programmes which were selected for EU funding will tackle animal diseases that impact both human and animal health. The large EU contribution towards these programmes reflects the high level of importance attached to disease eradication measures, for the protection of both animal and public health.
Markos Kyprianou, Commissioner for Health and Consumer Protection, said: "Safeguarding animal health is an essential factor in ensuring food safety, and in avoiding the often devastating consequences that animal epidemics can have. The decision to allocate considerable resources to the fight against animal diseases shows the Commission¡¯s unwavering commitment to this goal.¡±
Each year the Commission approves programmes for the eradication and monitoring of animal diseases, for the control of zoonoses such as salmonella, for the monitoring and eradication of TSEs and for avian influenza surveillance. These approved programmes receive financial contributions from the EU.

Animal disease eradication programmes
For the year 2008, 61 annual or multi-annual programmes to eradicate 10 important animal diseases have been granted Community financial support. The total EU contribution to these programmes is ¢æ70.075.000. The increased budget for 2008 from ¢æ52.97.000 in 2007 is mainly due to an increased allocation to counter Bluetongue disease in many Member states.
Within this budget, diseases that might be transmitted to humans are prioritised. Significant sums are being spent on the eradication of brucellosis, tuberculosis and rabies. Following the success of the programmes in recent years which have virtually eradicated rabies in the western part of the EU, most of the activity in 2008 will be focused towards the eastern Member States. ¢æ13.847.000 has been allocated to this task. Rabies is spread by infected wildlife and the programmes aim at producing immunity in the wildlife by orally vaccinating them with baits containing vaccine.

Zoonoses control programmes
A financial contribution of ¢æ8.606.000 to control zoonotic salmonella in poultry (Gallus gallus) breeder flocks in 19 Member States as well as ¢æ21.330.000 in poultry laying hens flocks (first year) have been allocated for 2008. This is three times the amount allocated for this disease in 2007, reflecting the priority which the EU gives to reducing the prevalence of salmonella in poultry

Avian influenza surveillance
Member States will also continue to carry out surveillance for avian influenza in poultry and wild birds in 2008 with financial assistance from the EU towards laboratory testing and wild birds sampling costs. A total of ¢æ4.344.000 will be available from the EU budget.

This surveillance is the most effective way to detect early outbreaks of both high and low pathogenic influenzas and was extremely useful in 2006 and 2007, allowing early detection of avian influenza in wild birds before commercial flocks became infected.

BSE/TSE monitoring and eradication programmes
The overall trend is positive and is improving year by year due to a good implementation of the monitoring and eradication programmes in most Member States.

For the monitoring of TSEs, the Commission has agreed to make ¢æ62.494.500 available from the EU budget, down from ¢æ 88.463.000 in 2007. It includes financial support from the Community that will be used to carry out rapid tests for the detection of TSE in cattle, sheep, goats and deer and discriminatory tests to exclude BSE in small ruminants as in 2007. For BSE eradication programmes across Europe, the EU will give ¢æ2.543.000 in co-funding in 2008, down from ¢æ5.400.000 in 2007, reflecting the continuing decline in BSE cases.

Compulsory Scrapie eradication measures are in place, requiring the culling and/or genotyping of animals in infected flocks. Breeding programmes continue to be applied for TSE resistance in sheep. This year, ¢æ18.184.200 is being dedicated to the approved scrapie eradication programmes, down from ¢æ33.592.000 in 2007, reflecting the uptake of funds in 2006.

Nanotechnology candy to thwart bioterrorism and food contamination
Source of Article:

(Nanowerk Spotlight) Talking about the threat of terrorists using bioweapons is a great tool for scaring people. Using any kind of pathogen (bacterium, virus or other disease-causing organism) as a weapon certainly is a terrifying scenario; think about the near-panic the 2001 anthrax attacks in the United States caused. Letters containing anthrax spores were mailed to several news media offices and two U.S. Senators, killing five people and infecting 17 others. Can you image what panic would result from an attack that kills 5,000 people and causes 76 million illnesses? Well, as a matter of fact, foodborne diseases cause approximately 76 million illnesses, 325,000 hospitalizations, and 5,000 deaths in the United States each year. Known pathogens account for an estimated 14 million illnesses, 60,000 hospitalizations, and 1,800 deaths (CDC data). The Food and Drug Administration¡¯s (FDA¡¯s) 2005 Food Code states that the estimated cost of foodborne illness is $10?$83 billion annually (source). So while the U.S. spends billions of dollars securing its borders, it loses many more billions, not to mention thousands of lives, every year by not being able to keep its spinach and hamburgers safe. Apparently, talking about terrorism is much better political theater (and makes for catchier Nanowerk Spotlight titles) than discussing E. coli outbreaks. However, be it because of potential terrorists or actual contaminated food, research in microbial detection and decontamination processes increased significantly over the past years. Traditional methods of identifying and subsequently removing a pathogen are slow and cumbersome. Now, using nanotechnology, researchers have designed a novel biosensing system that can identify E. coli in just five minutes and remove up to 88% of the target bacteria.

Traditionally, identifying a pathogen such as E. coli, Salmonella or Listeria requires cell culturing, which takes time ? time that often means more contamination and illnesses or even deaths. Here is an example from the FDA's recommended method for determining E. coli:

Weigh 50 g food into sterile high-speed blender jar. Add 450 mL of Butterfield's phosphate-buffered water and blend for 2 min. Prepare decimal dilutions with sterile Butterfield's phosphate diluent. Number of dilutions to be prepared depends on anticipated coliform density. Shake all suspensions 25 times in 30 cm arc or vortex mix for 7 s. Do not use pipets to deliver <10% of their total volume. Transfer 1 mL portions to 3 LST tubes for each dilution for at least 3 consecutive dilutions. Hold pipet at angle so that its lower edge rests against the tube. Let pipet drain 2-3 s. Not more than 15 min should elapse from time the sample is blended until all dilutions are inoculated in appropriate media. Incubate LST tubes at 35¡ÆC. Examine tubes and record reactions at 24 ¡¾ 2 h for gas, i.e., displacement of medium in fermentation vial or effervescence when tubes are gently agitated. Re-incubate gas-negative tubes for an additional 24 h and examine and record reactions again at 48 ¡¾ 2 h. Perform confirmed test on all presumptive positive tubes (which takes another 2 days).

It is a nobrainer that a detection system that takes days to positively identify a potentially deadly pathogen contamination is not good enough. What is urgently needed is a rapid way to detect the presence of a pathogen as well as the strain identity. That's were nanotechnology techniques could come to the rescue.

"We demonstrate the potential of sugar-coated magnetic nanoparticles for fast bacterial detection and removal, which provides an attractive avenue for pathogen decontamination and diagnostic applications" Dr. Xuefei Huang tells Nanowerk.

Huang, an Associate Professor in the Department of Chemistry at the University of Toledo, together with his collaborators from the university, developed a magnetic glyco-nanoparticle (MGNP)-based system to not only detect E. coli within 5 minutes, but also to remove up to 88% of the target bacteria from the medium. This system also allows easy determination of the identities of three different E. coli strains on the basis of the response patterns to two MGNPs highlighting their potential in biosensing.

The findings have been reported in a recent article in the Journal of the American Chemical Society ("Magnetic Glyco-nanoparticles: A Unique Tool for Rapid Pathogen Detection, Decontamination, and Strain Differentiation").

Huang and his team decided to use magnetic nanoparticles since their high surface/volume ratio offers more contact surface area for attaching carbohydrates and for capturing pathogens. Nanoparticles typically are about two orders of magnitude smaller than a bacterium, allowing many nanoparticles to attach to a bacterial cell, which aids in removing the bacteria.

"Pathogens such as bacteria and viruses often have a 'sweet tooth' which allows them to bind with mammalian cell surface carbohydrates to initiate infection" Huang explains. "To mimic this effect, we decorated the surface of MGNPs with carbohydrate moieties capable of binding surface recognition elements. This leads to particles with robust recognition capabilities and with the advantage of being magnetic."

Schematic demonstration of pathogen detection by MGNPs. (Image: Dr. Huang, University of Toledo)

In their experiments, Huang and his team found that when the MGNP are introduced to a pathogen, the pathogen latches onto the sugar. Once the pathogen has been captured, using a magnetic field the researchers were able to remove up to 88% of the E. coli, 65% in the first five minutes. This is much higher than most current systems using antibodies.

In addition, the technique can differentiate one pathogen strain from another. Because various strains of bacteria can have very different binding affinities with a sugar, the response patterns of bacteria to MGNPs can be deciphered allowing the identification of the bacterium strain.
Huang points out that the principle of this is very similar to how our tongues detect different flavors or how our noses register different smells. "Our technique is unique as it can be used to detect, decontaminate, and differentiate bacteria using the same system" he says.

It appears that this technique has considerable commercial potential: The magnetic glyco-nanoparticles are very simple and inexpensive to fabricate. The carbohydrate moieties on the exterior surface can be easily varied to adapt for specific pathogens. Unlike antibodies, they are also very stable at room temperature and thus do not need special facilities to store, which bodes well for field application.

The possibility of using this system not only to rapidly detect but also to decontaminate a suspected sample makes it particularly attractive.
"Our proof-of-principle demonstration ? using a MGNP system to rapidly identify and decontaminate E. coli ? not only paves the way for developing nanoparticles with more complex carbohydrates but also exhibits the power of nanotechnology in biosensing" says Huang. "In the next stage of work, we will use glyco-nanoparticles to differentiate a larger number of different pathogens. We will work on enhancement of detection limit and specificity. Besides pathogens, we also plan to examine the possibility of detecting cancer cells using this technique."

By Michael Berger

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