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The E-Coli Loophole Might Need Closing

Mike

Well-known member
Beef warning overdue

By: DENNIS M. CLAUSEN - For the North County Times

The decision to stop serving beef at all North County schools addresses the immediate problem that started when Chino's Westland Meat Co. processed "downed" cows that carry a greater potential for disease, including E. coli. The decision does not, however, remove the threat of some future E. coli outbreak in our area.

According to press reports, the U.S. Department of Agriculture has apparently been pressured by meat companies to cook and sell meat on which E. coli, a bacteria that can sicken and even kill humans, is found during processing. The USDA policy has become known as the "E. coli loophole."

Although this E. coli-tainted beef will be labeled "cook only" to alert consumers to the presence of the potentially lethal bacteria, some federal meat inspectors are deeply concerned. They point out that this practice allows higher levels of E. coli to be permissible in meatpacking plants. This, in turn, raises the likelihood that E. coli-tainted beef labeled "cook only" could easily contaminate other beef products in these plants.


Department of Agriculture officials admit that some cook-only beef products tainted with E. coli could have ended up in school lunch programs. They assure parents and school officials, however, that this is a safe practice, so long as the beef is fully cooked.

San Diego County is no stranger to E. coli food poisoning. The most infamous outbreak occurred in 1993, when San Diego-based Foodmaker Inc.'s chain of Jack in the Box fast-food restaurants was identified as the source of E. coli. More than 500 people became seriously ill from the bacteria, and four people died. Foodmaker was tied up for years in litigation, and Jack in the Box restaurants had to overcome enormous obstacles to regain their reputation as a safe place to eat beef products.

More recently, California's produce farmers actually requested federal government oversight in the aftermath of a 2006 E. coli outbreak. California's spinach farmers lost more than $100 million and considerable consumer confidence in their product after the 2006 outbreak.

Since 2006, the local media have reported on several area E. coli cases, but they appear to be isolated. The USDA's policy on E. coli-tainted beef, however, could create a significant outbreak. All it would take is for one "cook only" batch of beef to contaminate other beef products during processing, or for one cook to undercook beef that is labeled "cook only," and lives would once again be put at risk.

The decision to indefinitely remove beef from the menus of all North County schools, including those supplied by companies other than Westland Meat Co., is an important first step. Federal officials should take the next step and permanently eliminate the E. coli loophole.

San Diego County, especially, should be wary of the USDA's cook-only policy. We have already had more than our share of E. coli outbreaks and the devastating human and economic losses that follow in their aftermath.

Escondido resident Dennis M. Clausen is a freelance columnist for the North County Times.
 

Kato

Well-known member
Here's a solution.......

Animal Health News Release
Bioniche E. coli O157:H7 Cattle Vaccine Authorized for Field Use in Canada

22/12/06

BELLEVILLE, ON, December 22, 2006 – Bioniche Life Sciences Inc. (TSX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today received authorization from the Canadian Food Inspection Agency (CFIA) to distribute its E. coli O157:H7 cattle vaccine to Canadian veterinarians under a Permit to Release Veterinary Biologics as specified in the Canadian Health of Animal Regulations. This authorization equates to what is referred to as a “conditional license” in the U.S. This is the first vaccine technology for control of E. coli O157:H7 to be authorized for field use by a regulator globally. The vaccine is indicated for the reduction of shedding of E. coli O157:H7 bacteria in cattle.

“The Bioniche E. coli O157:H7 vaccine, developed through a partnership with the University of British Columbia, the Vaccine and Infectious Diseases Organization (VIDO) at the University of Saskatchewan and the Alberta Research Council, is a world’s first,” said Graeme McRae, President & CEO of Bioniche Life Sciences Inc. “Bioniche believes that this vaccine will be an important factor in helping to reduce the prevalence of this toxic bacterium, first implicated in meat contamination and now being increasingly identified as a contaminant of produce. CFIA’s approval gives the Company a clear and manageable pathway to full licensure.”

In order to progress from a Permit to Release Veterinary Biologics to a full license, the CFIA indicated that Bioniche must provide additional data confirming reduction in E. coli O157:H7 shedding by vaccinated animals. The Company believes that this requirement will be met in 2007.

“This vaccine will ensure that Canadian cattle producers continue to provide a safe product for Canadian consumers,” said Dr. Lorne Babiuk, Director of the Vaccine and Infectious Disease Organization (VIDO) and Canada Research Chair in Vaccinology and Biotechnology in Saskatoon, Saskatchewan. “More importantly, the reduction of E. coli shedding into the environment will have far-reaching consequences regarding environmental contamination. The recent outbreaks of E. coli infection from consumption of vegetables is an example of additional benefits of such a vaccine. The key discovery to making this vaccine a reality was made by Dr. Brett Finlay at the University of British Columbia, when he deciphered the mechanisms by which E. coli attaches to and infects animals. Using this knowledge, it was possible to target the specific proteins of the bacterium for use in the vaccine.”

Recent outbreaks of E. coli O157:H7 affecting spinach and other produce in North America have highlighted the fact that this is an increasingly serious human health threat that goes beyond meat (the first major foodborne outbreak of E. coli O157:H7 occurred in 1982 and was associated with ground beef). Human exposure to E. coli O157:H7 is being increasingly associated with contaminated fruit, vegetables, unpasteurized milk and fruit juice, potable and recreational water, and from direct contact with animals at fairs and petting zoos.

Clinical trials have been conducted with the Company’s vaccine over the past four years involving more than 30,000 cattle. Studies have consistently shown a significant decrease in the number of cattle shedding these deadly bacteria in their manure. In a controlled experiment conducted at VIDO, vaccinated cattle were challenged with a very large dose of bacteria, and there was a reduction in the magnitude of shedding by 99.47%. In clinical trials conducted by the University of Nebraska-Lincoln in commercial feedlot settings (where vaccinates and non-vaccinates were mixed), there was a 75% lower prevalence of E. coli O157:H7 in cattle vaccinated with two doses of the Bioniche vaccine. Another three-dose vaccination study was performed by the university, which showed that vaccinated cattle were 98.3% less likely to colonize the bacteria in their intestine.


And here's the progress made so far....

Beef Cattle Vaccinated Against E. coli O157:H7

24/09/07

- Top Meadow Farms world’s first commercial adopter of vaccine -


BELLEVILLE, ON, September 24, 2007 – Bioniche Life Sciences Inc. (TSX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today announced that its vaccine against E. coli O157:H7 in cattle has been used for the first time by a commercial beef producer. Top Meadow Farms, an Ontario-based producer of premium beef, integrated use of the E. coli O157:H7 vaccine into its Top in Field™ cattle rearing standards, under the auspices of Canadian Food Inspection Agency (CFIA) regulations governing the sale of the vaccine in Canada.

“Top Meadow is committed to producing beef that is of the best possible taste and healthfulness,” stated Kym Anthony, owner of Top Meadow Farms. “The Bioniche vaccine provides an important pre-harvest intervention against E. coli O157:H7 that we are very pleased to add to our CFIA-audited Top in Field™ feed and husbandry protocols. Equally, we are pleased to have the support of retailers of our beef, such as the Highland Farms grocery chain and the award winning Via Allegro restaurant: All of us take food safety to be a core obligation.”

“The adoption of our vaccine by Top Meadow Farms provides evidence that a beef producer recognizes the environmental and public health benefits that can result from reducing the shed of E. coli O157:H7 bacteria by cattle,” said Graeme McRae, President & CEO of Bioniche Life Sciences Inc. “Shed bacteria can contaminate food, water and the environment, and human exposures to this pathogen result in an estimated 100,000 cases of illness per year in North America.”

The vaccine remains under review by The Canadian Food Inspection Agency (CFIA) and The United States Department of Agriculture (USDA). In the course of its review process, the CFIA notified Bioniche last December that it was agreeable to issuing permits under the Permit to Release Veterinary Biologics regulations. These regulations allow cattle owners, through their veterinarians, to request vaccine be supplied to them by Bioniche.
Since that time, Bioniche has commenced production of the E. coli O157:H7 cattle vaccine at its Belleville, Ontario facility. This supply is now being provided to veterinarians requesting vaccine under the Canadian Permit to Release regulations. Bioniche will continue to scale up as full domestic and international approvals are received. Until such approvals are received, all vaccine will be shipped to Canadian veterinarians as permit requests are received and approved by the CFIA.

In order to progress from shipping under permits to a full license, the CFIA indicated that Bioniche was required to provide additional data confirming reduction in E. coli O157:H7 shedding by vaccinated animals. This information was provided to the CFIA in the spring and is currently under review.
 

Kato

Well-known member
Wait a minute! Found another one.

Food Safety News Release
USDA Agrees to Grant Conditional License to Bioniche for its E. coli O157:H7 Cattle Vaccine

05/02/08



BELLEVILLE, ON, February 5, 2008 – Bioniche Life Sciences Inc. (TSX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today received notice from the United States Department of Agriculture (USDA) that the latest data for its E. coli O157:H7 cattle vaccine “meets the 'expectation of efficacy' standard” and is eligible for a conditional license, providing that the Company develops a plan "that would collect sufficient data to move the product to full licensure". The conditional license, when granted, will provide the Company full access to the U.S. market with two restrictions: At least one step in the manufacturing process must be performed in the United States and Bioniche will not be permitted to use a trademark name for the vaccine.


The Bioniche vaccine is the world’s first vaccine that may be used as an on-farm intervention to reduce the amount of E. coli O157:H7 shed by cattle. Bioniche and its collaborators have been moving the vaccine towards commercial availability for eight years and it has been extensively tested at the University Nebraska-Lincoln, with efficacy results now being published in peer-reviewed scientific journals, most recently, the Journal of Food Protection, in November, 2007. The E. coli O157:H7 cattle vaccine will be manufactured in the Bioniche production facility in Belleville, Ontario, Canada where a two-year, $25 million expansion is taking place. Vaccine supply will be limited during this manufacturing expansion period.


"This is a large step forward for the E. coli O157:H7 vaccine," said Graeme McRae, President & CEO of Bioniche Life Sciences Inc. "The granting of a U.S. conditional license will permit U.S. beef and dairy producers access to a scientifically-validated means to reduce the risk of E. coli O157:H7 contamination."


Rick Culbert, President of Bioniche Food Safety, added, "There are an estimated 97 million cattle in the United States, many of which carry and shed E. coli O157:H7. We look forward to working with producers to implement vaccination as the first licensed on-farm intervention for E. coli risk reduction."


In order to begin providing vaccine to U.S cattle producers, the Company is required to produce three validated production lots, which will be filled in the United States, in accordance with the Virus-Serum-Toxin Act of 1913, as amended 1985.


It has taken some months for USDA reviewers to complete their assessment of vaccine efficacy data against a pathogen with a complex life cycle in variable real-world environments. Both the USDA and Bioniche have been diligently working through these challenging issues with a view to benefiting public health and the cattle industry. "We are very pleased that the USDA reviewers recognize the scientific merit and importance to the market of this vaccine," added Mr. McRae. "The vaccine is especially novel in that it reduces shedding of an organism that, while potentially lethal to humans, causes no disease in cattle. As a result, it was particularly challenging for regulators – understanding the many implications of this vaccine as a tool in reducing the shedding and colonization of E. coli O157:H7 in cattle."
 
A

Anonymous

Guest
Food Safety
USDA names new deputy under secretary for food safety

By Ann Bagel Storck on 2/12/2008 for Meatingplace.com




Agriculture Secretary Ed Schafer announced the appointment of H. Scott Hurd as deputy under secretary for food safety at the U.S. Department of Agriculture.

The position had been open since Kurt Mann left last year.

Hurd comes to the Food Safety and Inspection Service from Iowa State University, where he has served as an epidemiologist in the College of Veterinary Medicine for the past three years. At Iowa State, Hurd led research of epidemiology and food risks affecting human health. He specializes in salmonella, campylobacter and antibiotic resistance risk assessments.

Prior to becoming an associate professor at Iowa State, Hurd served in USDA's Agricultural Research Service and the Animal and Plant Health Inspection Service from 1989 to 2004.
 
A

Anonymous

Guest
Sleeping with the enemy
Is FSIS making its food-safety assessments on the wrong plants?


(MEATPOULTRY.com, February 07, 2008)
by Steve Bjerklie

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




Stunned by the surge in E. coli adulterations that vexed the U.S. beef industry for much of 2007, the U.S. Department of Agriculture’s Food Safety and Inspection Service issued Notice 65-07 in late October, admitting that the sudden, dramatic increase in E. coli recalls raises "questions about the adequacy of the interventions and controls that beef operations… are employing to address this pathogen."

But for John Munsell, the questions being raised, particularly by Notice 65-07, aren’t the right ones, and on January 18, at the invitation of USDA Under Secretary for Food Safety Dr. Richard Raymond, he met with Raymond and the FSIS leadership to voice his concerns – an interesting turn of events for the agency, which has in the past tended to turn a deaf ear to critics and naysayers.

In an email to MEAT & POULTRY, Munsell wrote that Raymond "established the meeting as an opportunity to discuss pros and cons of the Notice and to clarify misconceptions that the Notice may have created in the industry." Agency officials reiterated for Munsell comments they made publicly: that the focus of Notice 65-07, which announced that FSIS would review, with a Food Safety Assessment (FSA), the HACCP plan of any plant that had not reassessed its plans in the wake of the E. coli surge, would first be on slaughter plants, especially large ones. But Munsell brought evidence to the meeting that FSIS had instead been targeting small plants, including two very small operations in Montana.

"My perception is that these facts embarrassed and angered some agency officials at the meeting, but they could not argue with validated truth," Munsell wrote to M&P. "These facts also reveal the agency’s bias against very small plants. I informed them that both Montana plants currently the target of agency FSAs had in fact conducted reassessments for E. coli last fall, but nevertheless were still being subjected to FSAs. I also reminded them that agency press releases had been stating that FSIS would focus on large plants first."

But it wasn’t the officials’ angry reaction to evidence of small-plant targeting that truly shocked Munsell, he wrote. "They stated that plants which did assess for E. coli, and determined that they did not need to change their HACCP plans, would be targeted for FSAs. In other words, if plants do not change their HACCP plans, FSIS would respond (retaliate) with intensive FSA investigations."

The agency, in the opinion of Munsell, who has been arguing with FSIS for several years that it is looking for E. coli in the wrong places and blaming small processors for problems that are actually occurring, Munsell believes, further upstream, "wants to dictate HACCP plan changes to the industry." This is counter, he says, to previous FSIS statements that the agency would not tell companies how to write HACCP plans. "They had said they won’t do so because if FSIS did do so and problems ensued, then the agency would be responsible. In other words, FSIS admitted that it could not dictate to the industry what must be in their HACCP plans, and that each company could write their plans as they desired."

Notice 65-07 was accompanied by a 25-page questionnaire about in-plant pathogen interventions that plants were required to complete. "The irony," wrote Munsell, "is that the mega slaughter facilities, with fast chain speeds that unwittingly allow pathogens to be shipped into commerce have already implemented the majority of these expensive interventions, answered ‘Yes‘ to the variety of questions in Notice 65-07, which insulates them from agency FSAs." Smaller operations could not answer as many questions in the affirmative, thus making themselves vulnerable to agency scrutiny even though the surge, which engulfed even some of the beef industry’s most sophisticated large plants, proves that existing interventions aren’t necessarily effective. Moreover, Munsell believes, the design of Notice 65-07 to zero in on small plants rather than on the real source of the E. coli problems "was fully understood as FSIS officials authored" the notice.

Even so, the real problem may go much deeper and may involve an article of faith that FSIS has clung to since the inception of the HACCP era. "I firmly believe that [FSIS officials] are not willing to acknowledge that the source of ongoing adulterated meat – the large slaughter facilities – should receive in-depth FSAs, because their HACCP plans are impeccably written and they have already incorporated multiple-hurdle pathogen intervention steps. In other words, a mega-slaughter plant which has a HACCP plan worthy of Pulitzer Prize consideration simply cannot, theoretically, introduce E. coli into the food pipeline, in spite of 2007’s ugly incidents," wrote Munsell to M&P. "We’ve been told that HACCP is ‘science based.’ We’ve been told that the ‘hands off’ role of FSIS under the HACCP umbrella will force meat plants to police themselves and clean up their act. We’ve been told that pathogen intervention steps are the key to reducing the incidence of E. coli adulteration of beef. We’ve been told that jettisoning previous national standards for meat inspection and replacing them with customized HACCP plans at each plant would improve food safety objectives. We’ve been told that company-generated paper flow at each plant is greatly superior to previous USDA intensive overview at each plant in accomplishing food safety imperatives. We’ve been told that plant-conducted microbial testing in deference to agency-conducted testing is best for consumers. Then 2007 happened," Munsell pointed out. "Frankly, we’ve been fed a lie."

Still, Munsell thinks his Jan. 18 give-and-take with FSIS was productive in at least one regard: "As a result of our meeting, I believe FSIS officials realize the stupidity and financial irresponsibility of conducting lengthy FSAs at very small plants and will change their modus operandi."

But the vocal, prolific critic of current FSIS policy remains skeptical the agency will truly change its thinking and ways. "If the agency truly desires to determine the origin of E. coli and implement meaningful corrective action, it could accomplish this before the end of 2008. I’m not holding my breath. Neither am I consuming ground beef unless sourced at a small non-automated establishment." For him the bottom line, Munsell wrote, is this: "FSIS needs to implement large increases in pathogen testing and aggressively force the source to implement corrective actions. And: no more placements of artificial restrictions which prevent tracebacks to the source."

He added: "The revolving door between the agency and industry groups guarantees that the agency will not take aggressive actions against its own best friends. This isn’t nepotism: it is bilaterally voluntary incest. They are, figuratively speaking, sleeping together."

http://www.meatpoultry.com/news/beyond_stories.asp?ArticleID=91126
 
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