U.S. EPA Registers PURE Bioscience’s SDC-Based Food Contact Surface Sanitizer
Patented Ionic Silver Formula Registered for Use in Farms, Food Processing Plants, Restaurants and Homes
SAN DIEGO, Calif., August 18, 2009 – PURE Bioscience (NASDAQ: PURE), creator of the patented silver dihydrogen citrate (SDC) antimicrobial, announced today that it has obtained U.S. Environmental Protection Agency (EPA) registration for its SDC-based sanitizer for food contact surfaces. The new sanitizer was registered by PURE’s wholly owned subsidiary, ETI-H2O, under the trade name Axen®50 for sanitization of food contact surfaces and equipment in dozens of environments including farms, food processing plants, schools, hospitals and other institutions, restaurants and homes.
Michael L. Krall, President and CEO of PURE Bioscience commented, “This long-awaited registration opens new, major markets for PURE Bioscience. Foodborne illnesses create significant health and economic problems in the U.S. and internationally, and PURE welcomes the opportunity to offer a technology to help stem the spread of these dangerous pathogens that cause millions of illnesses.”
Krall continued, “The EPA’s registration of Axen50 as a food contact sanitizer cleared a big hurdle for PURE. Now that we’ve established a food contact tolerance of 50 parts per million of silver, this registration provides two roads to market for SDC-based food contact surface sanitizers via the EPA. We plan to add the extensive broad-spectrum antimicrobial claims from our existing disinfectant registration to the registration of the new food contact sanitizer, and, also through the EPA, we expect to amend our disinfectant product registration claims to add the new food contact sanitization claims. The EPA regulatory work will include state registrations by distributors and is expected to take at least six months.
“In addition, this registration accelerates our ongoing pursuit, through USDA, of additional direct food contact applications of SDC-based formulations as antimicrobial processing aids.”
The CDC estimates that foodborne pathogens cause 76 million illnesses per year in the US resulting in 325,000 hospitalizations and 5,200 deaths. And although Americans have come to expect such risks associated with meat products like raw hamburger, the proportion of outbreaks caused by seemingly innocuous fruits and vegetables is increasing. E. coli alone causes approximately 70,000 infections each year, and 5-10% of those infected develop a potentially fatal kidney complication called hemolytic uremic syndrome.
Foodborne illness creates not only health but also confidence issues for consumers. Food recalls can cause a significantly negative economic impact on businesses. For example, Salmonellosis is estimated by the CDC to cost more than $1 billion in medical costs and lost wages annually.
Krall concluded, “This summer’s recall of more than 5 million pounds of beef because of suspected E. coli contamination is just one example of a string of recalls in the US this year including the well-publicized cookie dough recall and the wide-reaching recalls of peanut and dried milk products. SDC-based food contact surface sanitizers will offer the same benefits of efficacy as our disinfectants along with the same remarkable Category IV toxicity for which no warning statements are required. In addition, SDC-based food contact sanitizers are odorless, colorless, non-corrosive, do not require hazardous materials procedures or gear and do not require rinsing after use. We believe that this combination of unique benefits creates a competitive edge for SDC-based food contact sanitizers.”
Food contact surface antimicrobials are processed as “sanitizers” by the EPA and, if registered, can only carry a 60-second sanitization claim, even if laboratory testing demonstrates faster kill times.
SDC is an electrolytically generated source of stabilized ionic silver. As a platform technology, SDC is distinguished from competitors in the marketplace because of its superior efficacy, low toxicity and the inability of bacteria to form a resistance to it. The first new disinfectant active to be registered by the EPA in more than 30 years, SDC-based disinfectants are antiviral, antifungal and antibacterial, including a 30-second kill and 24-hour residual protection against standard indicator bacteria and a two-minute kill claim on MRSA (Methicillin-resistant Staphylococcus aureus), CA-MRSA, PVL-MRSA and VRE (Vancomycin resistant Enterococcus faecium). Moreover, SDC-based disinfectants are odorless, colorless, non-corrosive, non-flammable and are compatible with other disinfecting and cleaning chemicals.
About PURE Bioscience
PURE Bioscience develops and markets technology-based bioscience products that provide solutions to numerous global health challenges. PURE's proprietary high efficacy/low toxicity bioscience technologies, including its silver dihydrogen citrate-based antimicrobials, represent innovative advances in diverse markets and lead today's global trend toward industry and consumer use of "green" products while providing competitive advantages in efficacy and safety. Patented SDC is an electrolytically generated source of stabilized ionic silver which formulates well with other compounds. As a platform technology, SDC is distinguished from competitors in the marketplace because of its superior efficacy, reduced toxicity and the inability of bacteria to form a resistance to it. PURE is headquartered in El Cajon, California (San Diego metropolitan area). Additional information on PURE is available at www.purebio.com.
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