In the ongoing battle to keep the potentially deadly E. coli O157:H7 pathogen out of hamburger, a range of “killer strategies” has been proposed, among them: zap the meat with irradiation, test the hell out of it, check every carcass for surface contamination, and vaccinate every beef cow against E. coli.
phageclearance-iphone.jpgNow comes an “all-natural” strategy — one that recently received a thumbs-up from the U.S. Food and Drug Administration when the agency granted Baltimore-based Intralytix regulatory clearance for its phage-based EcoShield, which can significantly reduce or eliminate E. Coli O157:H7 in ground meat.
Intralytix CEO John Woloszyn told Food Safety News that while EcoShield is not a “silver bullet” for vanquishing E. coli, it does offer a “kill step” that can substantially reduce or eliminate E. coli O157:H7 by 95 to 100 percent.
He also said that getting the FDA clearance for the product “required a great deal of data and backup for its safety and effectiveness.”
A blend of three phages, EcoShield is harmless to humans, animals and plants, but provides broad protection against E. coli O157:H7.
What are phages?
Also known as bacteriophages, phages are naturally occurring viruses that can be very effective in killing bacteria. They are everywhere —  inside of us, on our skin, in the soil, inside and on the outside of plants and animals, and even in the ocean. They go after specific targeted bacteria, infecting and then killing them.
Before the advent of antibiotics, phage therapy was used against a range of human diseases with varying results. With the growth of antibiotic resistance, it is now being viewed as an alternative to antibiotics, in some cases.
Intralytix has produced a short, easty-to-understand video that shows how phages work against foodborne pathogens.

Woloszyn described using phages against foodborne pathogens as “revolutionary,” pointing out that it’s an “all-natural approach toward food safety.”
“Most thinking in the Western World is that you need to use harsh chemicals or irradiation against pathogens instead of the powers of Mother Nature,” he said, adding that consumers are increasingly looking for “natural” food products.
Woloszyn said that phages provide “an all-natural, nontoxic, safe and effective means for significantly reducing or eliminating disease-causing bacteria that are sometimes present on foods.


“Making food safer nature’s way”  is a company slogan.
Looking ahead, Woloszyn said the company expects that “EcoShield will become a very important tool to make ground red meat safer.”
Describing other advantages of the product, Woloszyn said that unlike irradiation, EcoShield doesn’t affect color, taste or odor. It also meets Kosher and Halal certification requirements. 
Calling EcoShield an “important breakthrough,” Woloszyn pointed out that E. coli are surface contaminants and that when you grind beef up into hamburger, you’ve internalized the pathogen.
“This is the problem we solve,” he said.
What about beef trim?
There’s no doubt that hamburgers are an American favorite. Last year, consumers in this country ordered 2.2 billion hamburgers in restaurants, according to the NPD Group market research firm. That, of course, doesn’t include how many hamburgers they ate at home.

But hamburgers are of special concern to food-safety experts, public health officials, beef producers and consumers. That’s because if E. coli O157:H7 gets onto the surface of a piece of meat that gets ground into hamburger, the E. coli moves into the hamburger.  And while putting a piece of meat on a hot grill, for example, will kill the E. coli, hamburger has to be cooked until its internal temperature reaches 160 degrees to kill any E. coli that might be there.
hamburgers-grill-iphone.jpgThe problem with that, of course, is that many people like their hamburgers medium rare or rare, which means E. coli could be lurking inside of the burger.  Then, too, beef trim, which can be anything from meat pieces to exterior fat cut from steaks and other cuts, adds its own risks to the equation. Sometimes the trim is mixed into a slurry and doused with ammonia to clean it — a product dubbed “pink slime.” Beef trim is often added to hamburgers to keep costs down to consumers.
In 2009, Congresswoman Rosa DeLauro (D-CT) was worried enough about beef trim that she asked the USDA’s Office of the Inspector General (OIG) to launch an investigation of how beef is tested.
Specifically, she asked the Inspector General to look into the scientific merits and identify any shortcomings of  USDA’s N-60 testing system for beef.
The N-60 system requires USDA’s Food Safety and Inspection Service to remove 60 pieces of product from a lot so they can be tested for pathogens such as E. coli.
Earlier this month, the OIG  said that the USDA should thoroughly reevaluate the program, pointing out that the sample size and design might not do a good enough job of detecting O157:H7 in beef trim.
The OIG also recommended that the USDA move to an inspection system that will determine which processing plants are at a higher risk of E. coli O157:H7.
The report is Phase 1 of OIG’s response to a Congressional request to evaluate the N-60 program. In Phase II, OIG will look at the way testing is done at plants.
Early this month, USDA Inspector General Phyllis Fong “woke up” a few people during her presentation before a congressional subcommittee when she said that the N-60 testing program wasn’t working.
She told the subcommittee members that a recently completed audit assessing how the Food Safety Inspection Service samples beef trim for E. coli revealed that the procedure “does not yield a statistical precision that is reasonable for food safety.”
At the same time, she said that while 60 samples might be enough to detect widespread contamination, more are needed when E. coli is less prevalent.
Some beef-industry reps railed at that, saying that the more they do to eradicate E. coli from ground beef, the more testing the government wants to do.
One exasperated industry representative said the solution is simple enough: “Ban hamburgers.”
On March 18, USDA Under Secretary for Food Safety Elisabeth Hagen told participants at the North American Meat Processors’ Management Conference that the agency will probably call for increased testing of  beef trim and ground beef beyond the current N-60 sample rate, based on the OIG report.
But she also said that the USDA realizes that it can’t “test its way to food safety” and that even if it took 500 samples from a lot, it would be impossible to find every pathogen in every lot.
Some meat-industry reps propose that E. coli prevention be directed to sampling beef carcasses since that’s where E. coli is. They say that waiting to take samples until after the carcass is made into interior and exterior cuts doesn’t make any sense. If, instead, standardized ‘lot’ samplings were performed on the exterior of carcasses, results could be available before the carcasses left the cooler, thus reducing the likelihood that contamination would ever reach the processing floor.
But Intralytix CEO Woloszyn said that each meat-processing plant has its own procedures and therefore needs to craft a food-safety plan that matches its own operation  He pointed out that beef trim often falls on the floor or is handled by workers or comes into contact with equipment that might be harboring E. coli.
“Often the best time to use EcoShield would be just before the meat is ground,” he said.
EcoShield is applied in a very fine mist sprayed onto the meat. When necessary, the beef trim is rolled to make sure the mist covers all parts of the pieces of meat.
Woloszyn said it’s easy to apply the product and applications don’t require expensive equipment — either a spray box or battery operated spray bottles.  
As for cost, he didn’t supply a specific amount but said that it depends on how a processing plant is set up and what food-safety procedures it uses.
“We estimate the cost for each customer,” he said. “We think the cost is very competitive especially when some steps a plant is taking can be eliminated when EcoShield is used.”
Looking ahead
While the company doesn’t yet have any customers for EcoShield, Woloszyn said some potential customers “are looking very seriously at this product.”   “We’re very h
opeful about it,” he said.
In an email to Food Safety News, Michael Martin, spokesman for meat-giant Cargill, said that while FDA approval for use of EcoShield is “an encouraging development,” USDA has not approved it for use with meat products.
“Should USDA approval take place, Cargill would review the potential benefits of using EcoShield, just as we do with any measures that show promise and could potentially be added to our toolbox of food safety interventions,” Martin said.
The FDA and USDA’s Food Safety and Inspection Service (FSIS) work collaboratively on approvals of substances to be used in or on meat and poultry products. FSIS spokesman Neil Gaffney said the FDA has forwarded EcoShield’s request to FSIS and the submission is currently under review as a safe and suitable treatment for meat by the FSIS Office of Policy and Program Development’s Risk and Innovations Management Division.
“The review occurs simultaneously, with the intent to complete it within 2 months,” Gaffney said.
More phage weapons


In addition to EcoShield, Intralytix has another phage-based food-safety product, ListShield, which provides broad protection specifically against Listeria monocytogenes. According to the company’s website, the product significantly reduces contamination levels of various foods by 99 to 100 percent. It can also be used on surfaces in food processing facilities and other establishments.
ListShield is FDA- and USDA-approved for direct applications on food. And on the organic front, it’s OMRI-listed, which means the Organic Materials Review Institute approves its use in organic production.
The company has another phage-based product in the works, SalmShield, which targets selected, highly pathogenic Salmonella-serotypes in foods and food processing facilities.
In addition to baceteriophage-based food-safety products, Introlytix also focuses on the production and marketing of phage products to control bacterial pathogens in medical settings and the environmental.
Video, plus images of the EcoShield product and lab workers, courtesy of Intralytix.