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In December, the FDA asked animal health companies to voluntarily stop using antibiotics to promote growth of meatier cows, pigs, and other livestock. This is known as non-therapeutic use.
According to a recent report by the FDA, 25 sponsors confirmed in writing their intent to engage with FDA as defined in Guidance #213 and have given FDA consent to list their names in this update. These 25 sponsors hold 99.6 percent of the applications affected by Guidance #213 and include subsidiaries of Bayer and Eli-Lilly.
The guidelines are meant to thwart the growing problem of antibiotic resistance, which some scientists blame on antibiotics in the food supply. Drug-resistant bacteria strike 2 million Americans a year and cause 23,000 deaths, according to the CDC. The FDA has long been under fire for failing to keep a lid on antibiotic use in farm animals. In January, the Natural Resources Defense Council (NRDC) released a report containing evidence that the FDA’s scientists were aware of 18 farm antibiotics that posed a high risk of spawning antibiotic-resistant bacteria.
However, critics claim that 89 percent of antibiotic drugs that the guidelines advise against using to speed growth can still be given to healthy animals for other reasons, such as disease prevention. They also contend that since the system is voluntary, it gives the pharamaceutical companies too much discretion and leeway in conducting their own policy and enforcement methods, especially on large factory farms, and with easily obtained OTC (over the counter) drugs. Critics are demanding a complete ban on antibiotics/ antimicrobials for non-therapeutic use.
Following is a link to a recent Reuters News article which offers a well-balanced summary of this story.
Safe, Clean Produce
As you know, we have two daily electronic papers on our website linked to our twitter account; the Oxy Blast Digest and the Motala Water Report. We encourage you all to subscribe to them. There is always something of interest.
The article of interest today is testing of produce. You all should know this is a huge issue and could be solved by producers in-house. How? Well, the suggestion is that they shock their complete water system with Oxy Blast at 500 PPM. This dose will kill bacteria and allow for no further complications. Of course, we also want to make sure when doing this that the pH level is at 6. Now, they can use a maintenance dose of 50 PPM consistently, while keeping the pH at 6, and soak all vegetables in a clean disinfected sink for 30 minutes. They can now drain the sink. This will help them stay fresh longer.
As a matter of fact if you spray left over tossed salad with a 3% solution of Oxy Blast (mix 15 parts of water with 1 part Oxy Blast 50% in spray bottle). It will last longer and stay fresher longer in the fridge. My wife uses this formula to keep our complete kitchen and all bathrooms free of bacteria. If you spray some by the sink of your home you will see it with your own eyes – it bubbles and you can actually see it kill the bacteria!
In an ongoing effort to reduce the dependence and amount of antibiotics used in farming, USDA scientists at College Station, TX have discovered that providing sodium chlorate in the drinking water or feed of livestock will reduce the intestinal concentrations of bacteria harmful to humans.
You can read a summary of the report here: http://www.foodsafetynews.com/2012/06/usda-makes-progress-on-alternatives-to-antibiotics/
The use and/or overuse of antibiotics on farms continues to generate controversy. While opposite sides continue to argue their respective positions, we feel that it’s important to maintain a level-headed position and research and examine all of the facts.
Without a doubt, antibiotics have improved the quality of life for all of us, including our livestock and food sources. Can you imagine a world without anitbiotics? Scary indeed!
We strongly agree with the agricultural community that a responsible antibiotic regimen is essential to maintaining a safe, healthy and efficient operation. However, it’s also common knowledge that antibiotic use has surged during the past decade, which has many experts worried that we are creating a dangerous level of resistance to bacteria and viruses.
The prestigious journal Nature this week called for reining in the use of antibiotics in agriculture, adding to the growing chorus of scientists and public health advocates seeking reforms. The editorial noted that the overuse of antibiotics in livestock raising is a global issue, in part because pathogens do not respect international borders — “As long as any one country pumps its pigs and poultry full of drugs, everyone is at risk.”
Following are links to the report and comments.
While the debate rages on, and various special interest groups lobby all levels of government, please don’t blame the farmers! They are all working hard to ensure that we all have safe, healthy food to feed our families, and also incurring a lot of extra expense in doing so.
We would like to remind you that one of the many benefits of using our Oxy Blast products is the reduced dependency on antibiotics. Why? Because they help antibiotics work more effectively and efficiently! This has proven to be an economical option for many of our clients.
We invite you to watch our short movie presentation at www.oxyblast.org/movie, introducing our products and services.
FDA Publishes Guidances to Limit Use of Antimicrobials (antibiotics) in Livestock Production
Apr. 13, 2012 12:48pm
- The U.S. Food and Drug Administration (FDA) published a series of three documents in the Federal Register today as part of an effort to alter the use of antibiotics in food-producing animals.
National Pork Board
The U.S. Food and Drug Administration (FDA) published a series of three documents in the Federal Register today as part of an effort to alter the use of antibiotics in food-producing animals.
In a statement prior to today’s publication, FDA indicated that the issuance of three new documents will help veterinarians, farmers and animal producers use medically important antibiotics judiciously in food-producing animals by targeting their use to only address diseases and health problems. Under a new voluntary initiative, certain antibiotics would not be used for so-called “production” purposes, such as to enhance growth or improve feed efficiency in an animal. These antibiotics would still be available to prevent, control or treat illnesses in food-producing animals under the supervision of a veterinarian. There will be a three-year “phase in” period before these changes will become effective, but the exact dates of the phase-in period currently remain unspecified.
“It’s critical that we take action to protect public health,” said FDA Commissioner Margaret A. Hamburg, M.D. “The new strategy will ensure farmers and veterinarians can care for animals while ensuring the medicines people need remain safe and effective. We are also reaching out to animal producers who operate on a smaller scale or in remote locations to help ensure the drugs they need to protect the health of their animals are still available.”
The three documents published in today’s Federal Register include:
· A final guidance for the industry, Guidance 209, “The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals,” that recommends phasing out the agricultural production use of medically important drugs and phasing in veterinary oversight of therapeutic uses of these drugs.
· A draft guidance, Draft Guidance 213, open for public comment, which will assist drug companies in voluntarily removing production uses of antibiotics from their FDA-approved product labels; adding, where appropriate, scientifically-supported disease prevention, control and treatment uses; and changing the marketing status to include veterinary oversight.
· A draft proposed Veterinary Feed Directive regulation, open for public comment, that outlines ways that veterinarians can authorize the use of certain animal drugs in feed, which is important to make the needed veterinary oversight feasible and efficient.
FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidance documents are meant to describe the FDA’s current thinking on a topic. As the American Association of Swine Veterinarians pointed out in a news release, it should be noted that FDA intends to work with drug manufacturers to remove label indications for growth promotion and feed efficiency from products considered important for human health. Once these products are no longer labeled for production uses, it will be illegal for veterinarians or producers to utilize medicated feeds for these purposes.
The National Pork Producers Council (NPPC) is concerned that lost and restricted access to antimicrobial products expected to result from these steps likely will disproportionately affect small producers, have a negative effect on animal health, and increase the cost of producing food while not improving public health. NPPC makes the point that this action is a move to address an increase in antibiotic-resistant illnesses in humans, which opponents of modern animal agriculture blame on the use of antibiotics in livestock and poultry production.
However, numerous peer-reviewed risk assessments, including at least one by FDA, show a “negligible” risk to human health of antibiotics in food-animal production, according to NPPC.
Tom Talbot, a California beef producer, veterinarian and current chairman of the National Cattlemen’s Beef Association (NCBA) Cattle Health and Well-Being Committee, issued a statement that raises key points on this issue. “Antimicrobial resistance is a multifaceted, extremely complex issue that cannot be adequately addressed solely by focusing on the use of antibiotics in animal agriculture. Prudent and responsible evaluation of this issue must consider animal, human and industrial use of antibiotics. While we appreciate the agency working with industry on the implementation of Guidance 209, we remain committed that a strong science foundation is critical before moving forward with this guidance,” he states.
John Clifford, DVM, USDA Chief Veterinary Medical Officer, says, “USDA worked with FDA to ensure that the voices of livestock producers across the country were taken into account, and we will continue to collaborate with the FDA, the American Veterinary Medical Association and livestock groups to ensure that the appropriate services are available to help make this transition.”
FDA is currently accepting comments on Draft Guidance 213 and on the Veterinary Feed Directive document. Submit comments on these documents by the date provided in the Federal Register notice announcing the availability of the Draft Guidance (July 12, 2012). Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Submit electronic comments on the draft guidance to http://www.regulations.gov. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.