A new report concludes the federal government should provide more specific public guidance on the license approval requirements of vaccines that could reduce the incidence of E. coli O157:H7 and friends in cattle.

Because right now, it’s bureaucratic, and no one can offer a clear explanation.

The U.S Government Accountability Project in report GAO-12-257 (for sticklers) also concluded the Secretary of Agriculture should explore practices employed by other countries that are not currently used in the U.S. for reducing shiga-toxin producing E. coli (STEC) in cattle and consider whether the identified practices can inform U.S. efforts.

From the report:

U.S. Department of Agriculture (USDA) and university researchers identified several treatments administered before cattle are slaughtered, or preslaughter interventions, that could reduce Shiga toxin-producing Escherichia coli (STEC) in cattle. Such preslaughter interventions include bacteriophages (viruses that infect and kill bacteria), probiotics (live bacteria that can benefit the digestive system), vaccines (biological preparations that alter the immune system), and sodium chlorate (chemical that kills the STEC O157:H7 strain). However, few manufacturers have submitted applications for preslaughter intervention products to target STEC according to officials from USDA and the Food and Drug Administration. One exception is for vaccines to reduce STEC O157:H7.

For preslaughter interventions, USDA exercises responsibilities for licensing and regulating STEC vaccines. However, USDA’s approval requirements for these vaccines are unclear, according to some industry representatives. Specifically, USDA’s general guidance does not address some of the unique challenges faced by manufacturers of animal health products seeking STEC vaccine approval. For example, the guidance does not explain that, if studies conducted in the laboratory are insufficient to demonstrate efficacy, the manufacturer would also need to demonstrate that the vaccine is effective in a field setting such as a feedlot. In contrast, the Canadian Centre for Veterinary Biologics provides more specific guidance about when it requires the use of laboratory or field studies to demonstrate efficacy for vaccine license applications. Without guidance that gives manufacturers clear and more specific information they need to submit for an acceptable application, the approval process for STEC vaccines could face potential delays.

In addition to STEC O157:H7, which it stated in 1994 was an adulterant—a substance that renders food injurious to human health—in September 2011, USDA determined that six other STEC strains were adulterants in raw ground beef and beef trim (meat left after steaks and roasts are cut from beef). USDA has tests for these six strains and plans to use them in slaughter plants starting in June 2012. However, it may be difficult and time-consuming to confirm positive test results because certain test components are either not commercially available for all strains or do not always provide clear results. USDA is working to improve the tests and to find a commercial supplier for one key test component. Also, a few companies voluntarily test for these strains.

Some foreign governments have practices that could be relevant to U.S. efforts to reduce STEC in cattle such as the following:

The European Parliament and the Council of the European Union require certain measures, such as verification of cleanliness by an inspector, to ensure that the cattle going to slaughter are clean. In contrast, USDA assesses the health of cattle but does not inspect for cleanliness.
At least 12 European Union member countries collected and reported data on STEC in live cattle in 2009. USDA has conducted STEC testing in live cattle, but has not tested since 1999.
When a person becomes ill from E. coli in Sweden, government officials try to determine the specific farm that sold the contaminated cattle so that other carcasses from the farm can be tested for STEC. USDA does not trace the STEC source back to the farm.

The complete report is available at http://www.gao.gov/products/GAO-12-257.

Elizabeth Weise in USA Today doesn’t really answer the who-should-pay question, but does ask, what if it were possible to almost entirely do away with E. coli in ground beef and it would cost only about a penny a burger?

Food-safety experts say it's entirely feasible with new technologies that have become available. One is a vaccine, the other a feed additive, which, given early enough, could bring down potential E. coli contamination to negligible levels.

The problem, experts in beef safety say, is that the economics are backward. The new interventions have to be administered long before the cattle are slaughtered, when the calves are young or in feedlots where they're growing.

It's hard to figure out who should pay for steps that would take place months and possibly years before the grill starts sizzling. The people who'd have to pay for them aren't the ones who would reap the direct benefits.’’’

These interventions aren't perfect, but they're very good, says Guy Loneragan, a professor of food safety at Texas Tech University in Lubbock. "The question is no longer, 'Can we get the technologies?' We've got them, or they're soon to arrive. The question is 'How do we implement?' "

So far only two small companies appear to be embracing them. One is a tiny feed lot cooperative in Kansas that's looking to vaccinate all its cattle "soon." The other is a Meade, Kan., cooperative that's staking its economic life on calling for retailers nationally to demand these interventions from the packers that supply their meat.

The regulatory landscape "is confusing," says Elisabeth Hagen, USDA's undersecretary for food safety. "But we're realizing that there's an issue here and somehow we have to bring everybody together and focus on the end product, the result of which is the safety of the food that goes to the American consumer."

Loneragan says they've gone as far as they can after the animal is slaughtered. Now the focus needs to be on ridding the animals of E. coli O157:H7 before they get to the slaughterhouse. The new methods to do that involve:

•A vaccine. The biggest and potentially most game-changing treatment is a vaccine introduced by Pfizer Animal Health in 2010 and given in a three-shot series starting when the calf is just 6 months old. This gets rid of the E. coli O157:H7 bacteria in 85% of the cattle, says Brad Morgan, a senior food-safety specialist at Pfizer Animal Health in Stillwater, Okla. Not only that, but even among the ones that still have the bacteria in the gut, the injections reduce the amount the animals shed in their manure by 98%, he says.

It's not all or nothing. Pfizer has done studies showing that if only 50% or even 25% of cattle are vaccinated, rates of E. coli are strongly reduced in the feed yard, and therefore in the packing plant. And Harvard's Hammitt says his research shows that Americans understand that food can't be "perfectly safe," but they want safer.

The vaccine costs $4 to $6 per animal for the full series, says Loneragan. There are several other vaccines in the regulatory pipeline here and overseas.

•The probiotic. The other intervention is a probiotic added to feed. These are beneficial bacteria cultures that out-compete the more dangerous forms of E. coli in the cattles' guts, much as yogurt is said to seed the gut with good bacteria to keep out the bad. Many studies have found that using "the right strain at the right dose you can get a fairly predictable 40% to 50% reduction in E. coli O157:H7," says Loneragan.

The American Meat Institute Foundation, the research arm of the meat industry trade group, says there just isn't enough data yet to know if these treatments work. While there's been a tremendous amount of research and it looks promising, "We're right at the cusp of understanding the technology," says Betsy Booren, the institute's director of scientific affairs.

Last year Cargill, one of the nation's largest beef producers, conducted a trial of the E. coli vaccine on 85,000 head of cattle at its Fort Morgan, Colo., beef-processing facility, says spokesman Mike Martin at Cargill's Wichita headquarters.

The trial's results were "inconclusive," Martin says, in part because the levels of O157:H7 they found on the cattle in general "were the lowest in years . …" There was "very little difference" in rates between the vaccinated and the unvaccinated cattle, he says.

Loneragan says in the studies he's done, E. coli O157:H7 levels were indeed low but dropped lower in meat from vaccinated cattle.

In the end, it's going to take movement by the biggest companies to move the industry. There are two that could make this happen in a second, McDonald's and Wal-Mart, says Chuck Jolley, a meat industry marketing company executive.

"If either decides to require it, the industry will turn around on a dime," he says.

Every time some government type says there are more cases of E. coli O157:H7 and other dangerous bacteria in the summertime because people barbeque more, I cringe. It’s one of those blame-the-consumer comments when the reality is more complicated. 

Most food safety interventions are designed to reduce or eliminate pathogen loads – to lower the number of harmful bugs from farm-to-fork. A piece of highly-contaminated meat can wreck cross-contamination havoc in a food service or home kitchen.

Elizabeth Weise writes in USA Today today that animals carry higher levels of E. coli O157:H7 and friends during the summer months, and summarizes efforts to lower bacterial loads on animals entering slaughter plants.

Jerold Mande, USDA deputy undersecretary for food safety, said last month,

"To take the next big step forward on food safety, we need to do more to have fewer pathogens on food animals when they arrive at the slaughterhouse gate.”

Jim Marsden of Kansas State University said that microbiologically, the biggest "bang for the buck" is cleaning the bacteria off the hide or the carcass to keep it from coming into contact with the meat.

Weise writes that a number of possible interventions are in the works. Each, it is hoped, might take down the incidence of E. coli O157:H7 by a factor of 100. Below is the edited list.

Vaccines: Gut warfare

Probably the most hopeful are vaccines that lower the amount of O157:H7 in cattle's guts. Two are furthest along, one from a Minnesota company called Epitopix and one by a Canadian company called Bioniche Life Sciences. Epitopix's vaccine has received preliminary approval from the USDA and is being tested in the USA. Bioniche's vaccine was approved in Canada last year and is in the approval process in the USA. In addition, scientists at the USDA's National Animal Disease Center in Ames, Iowa, have developed two more vaccines.

Field trials of the Epitopix vaccine showed that 86% of vaccinated cattle stopped shedding O157:H7 bacteria in their feces. Of those that still were shedding bacteria, there was a 98% reduction in the amount, says Daniel Thomson (left, photo from USA Today), a veterinarian and professor of Production Medicine at Kansas State University in Manhattan, Kan., who has studied the effectiveness of vaccine for the company.

The issue for cattlemen will be the costs of the two or three shots necessary to create immunity and the wear and tear on the cattle caused by bringing them in to be vaccinated. Going through the chute that holds them still while they're given the shot, necessary to safeguard workers, can cause some cattle to become agitated.

Phages: A spray of bacteria fighters

Cattle walking through a car-wash-like spray of bacteria-eating viruses called phages sounds more science fiction than feedlot, but it's actually in use across the USA. In cattle, a phage that is specific to E. coli O157:H7 is sprayed on the animals one to four hours before they're slaughtered. "They like to have them soak," says Dan Schaefer, director of beef research and development at in Wichita. Cargill is testing the spray at one of its plants.

Probiotics: 'Exclusion' cultures

Basically these are bacterial cultures much like those in yogurt, given to cattle in their feed. They're called "competitive exclusion" cultures because they out-compete the bad bacteria and exclude them in the animals' guts. Michael Doyle, director of the Center for Food Safety at the University of Georgia in Griffin, spent years investigating them.

One for E. coli O157:H7 "worked really well for a while and then it stopped working for a while," he says. Doses required are often higher than those claimed by the companies that sell them, he says. Currently these aren't approved by USDA or FDA as E. coli reduction methods, so the companies that market them can't make any specific claims for them.

Sodium chlorate: A 'suicide pill'

This chemical is used in part to do environmentally safe paper bleaching. But administered in extremely small amounts, it also plays a deadly trick on E. coli O157:H7 and salmonella.

In the oxygen-free environment of a cow's gut, these bacteria are able to obtain energy from nitrogen. But they can't tell the difference between nitrogen and chlorate, so if there's chlorate present, they try to use that. This turns the chlorate into bleach, killing the bacteria from the inside without harming the animal.

Grain vs. high-quality hay

Research in Texas, Kansas and Idaho has shown that switching cattle from grain to a more expensive diet of high quality hay before slaughter may lower E. coli O157:H7 rates, though the findings have not always been consistent.

From an epidemiologic standpoint, it's clear that these pre-slaughter interventions lower the E. coli O157:H7 burden in the cattle, says Guy Loneragan, a professor of animal science and expert in O157:H7 in cattle at West Texas A&M University in Canyon, Texas.

The question is whether investing money on the ranch and feedlot will save money at the packing plant.

In a six-hour meeting yesterday, Sunday, August 23, at the Crowne Plaza Hotel in Trevose, Bucks County, Pennsylvania, the H1N1 flu vaccine was discussed. The main question was how to approach the public: “full throttle” and “go slow” options were debated. The meeting included watching videos about pandemics, vaccines, and the brief history of H1N1.

The vaccine would be taken on a voluntary basis regardless of the panel’s decision, but how educating the public, the benefits or risks of the vaccine, and possible mandating of the vaccine seems to be what most of the panel members are concerned with.

Prevention of H1N1 by handwashing did not seem to be a topic of conversation.

This meeting is one of ten that are occurring across the US. To read the full article, click here.