Mixed reviews for new FDA guidance

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The U.S. Food and Drug Administration on Wednesday issued a new guidance on the use of antibiotics in livestock production, drawing mixed responses from livestock organizations and groups opposed to antibiotics in agriculture.

The final Guidance 209 calls for voluntary suspension of non-therapeutic use of certain antibiotics in livestock

"Under this 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," said the FDA in a statement. "These antibiotics would still be available to prevent, control or treat illnesses in food-producing animals under the supervision of a veterinarian."

FDA also issued a draft proposed rule, which would encourage pharmaceutical companies to remove production uses of certain antibiotics from their FDA-approved product labels.

“NCBA raised concern with FDA’s Guidance 209 in 2010 because the agency lacked the necessary science in its recommendations,” says Tom Talbot, a California beef producer, large animal veterinarian and current chairman of the NCBA’s Cattle Health and Well-Being Committee. “ Antimicrobial resistance is 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.

 “The goal of giving veterinarians greater oversight of antibiotic use in food animals is commendable but cattlemen are concerned with the feasibility of implementing the veterinary feed directives given practical hurdles, including a current shortage of veterinarians in many rural areas throughout the country and the increased record-keeping burden it could have on the day-to-day requirements veterinarians currently face. We are pleased FDA has committed to working with farmers and ranchers, veterinarians and with the U.S. Department of Agriculture to seek additional information and address these concerns specifically to ensure family-owned farms and ranches are not negatively impacted by this regulation.

"It sounds to me that it is the expected guidance we knew was coming," Steve Kopperud, government affairs counsel for the American Feed Industry Association, told Dairy Herd Management, a sister publication to Drovers/CattleNetwork.

"It looks like they are heading in the right direction," he added. "It is critical this remains collaborative rather than a formal rule-making process."

A statement from the Animal Health Institute (AHI), which represents animal-health companies, agreed with the collaborative approach that FDA is taking with the various stakeholders.

"The veterinarian is critically important in animal care decisions and, ultimately, in protecting food safety and human health," the AHI said. "We strongly support responsible use of antibiotic medicines and the involvement of a veterinarian whenever antibiotics are administered to food producing animals.

"Implementation of this policy means all medically-important antibiotics used in animal agriculture will be used only for therapeutic purposes – disease treatment, control and prevention -- under the supervision of a licensed veterinarian. This policy will assure these medically important medicines are used in animal health in much the same way they are used in human health -- under the supervision of a licensed professional and only to address disease challenges at various stages," the AHI said

The National Pork Producers Council expresses concern that the new policy will disproportionately affect small producers, have a negative effect on animal health and increase the cost of producing food while not improving public health. “The guidance could eliminate antibiotics uses that are extremely important to the health of animals,” said NPPC President R.C. Hunt, a pork producer from Wilson, N.C. “And the requirement for VFDs could be problematic, particularly for smaller producers or producers in remote areas who may not have regular access to veterinary services.”

Advocates of stronger regulation of antibiotics in livestock expressed disappointment that the guidance relies on voluntary cooperation within the industry. Quoted in an AFP article Wednesday, Natural Resources Defense Council attorney Avinash Kar said "Public health authorities in the US and around the world agree that the overuse of vast quantities of antibiotics on livestock to hasten weight gain and compensate for crowded, filthy conditions is contributing to the crisis of antibiotic resistance in human medicine. This is an ineffective response to the real and sobering threat of rising antibiotic resistance, which threatens human health. Put another way, industry is not required to do anything," he said. "Even if a couple of actors make the right moves out of the goodness of their hearts, that won't ensure change in the whole industry, which is the level at which change is required."

However, a PorkNetwork article notes that several FDA officials stated at a Wednesday’s teleconference that there has been a “sea change” in the drug companies’ attitude toward the issue since FDA issued a draft Guidance 209 report in June 2010, suggesting that antibiotics be used judiciously and only when necessary to keep animals healthy. Since then, there has been “a very productive engagement” of the animal health community and the animal production community and “broad buy-in that the time has come to make this shift,” Michael Taylor, FDA deputy commissioner for foods, told reporters attending a teleconference.


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Luke Thomas    
April, 12, 2012 at 06:23 AM

80% of all American antibiotics goes to livestock because it stimulates growth, and highly contributes to the proliferation of superbugs highly contagious just by handling the raw meat (over half the raw meat has live MRSA which freezing will not destroy, VRE, even superbug C. diff). This voluntary withdrawal of antibiotics as a routine feed is going to be largely ignored because profit means more to the meat industry than public safety and you keep on buying it. PS Enjoy 70% of all ground beef in America is pink slime, but I would worry more about the antibiotics, arsenic, benadryl, caffeine, and so many other chemicals put in animal feed.

Burkie in Kansas    
Abilene, Kansas  |  April, 12, 2012 at 09:16 AM

Luke: Reading the new rules puts the onus right square on the AVMA. They either comply or else. This means we producers have to rely on them to pay to have a diagnoses made or else. They'll rape us. Prices on antibiotics over-the-counter, need to be frozen by FDA. If exhorbitant prices for prescribed drugs are done by the U.S. veterinarians, they can all realize they won't be utilized. This means animals that need treatment will go without. It also means Vets will that overcharge for prescribed meds will be held accountable for doing so, and NEVER used for their so-called "caring" services.

Personaes Non Grata on Farms and Ranches in the USA.

Not at my place, that's for sure. I've been raped too many times by veterinary fees for putting pills in an envelope.

Lillian    
Ohio  |  April, 12, 2012 at 09:34 AM

1. Just because someone called "pink slime" strudded trimmings, people has decided to stop eating meat ? How ridiculous ! If you level what is in ground beef, there is no problem.
2. If you have an outbreak, lets say: pneumonia in calves, by the time the vet services find the bug causing the disease,(about 2 weeks time in this state) most calves will be dead. So, we have to seat around until we are giving permition to treat the problem?

David    
Ozark, AR  |  April, 13, 2012 at 11:21 PM

Lillian: Do you do anything for prevention of disease so you might not use much if any antibiotics??

Burkie: Sounds like you got an oath for the Veterinarian; How about an oath for yourself? Maybe you should become a little more educated about diseases and business.. The Veterinarian Oath does not say anything about performing services or selling products @ cost or for nothing!!!!!! The OATH: "Being admitted to the profession of veterinary medicine, I solemnly swear to use my scientific knowledge and skills for the benefit of society through the protection of animal health and welfare, the prevention and relief of animal suffering, the conservation of animal resources, the promotion of animal health and the advancement of medical knowledge. I will "PRACTICE" my profession conscientiously, with dignity, and in keeping with the principles of veterinary medical ethics. I accept as a lifelong "OBLIGATION" the continual improvement of my professional knowledge and competence." As with any profession, there is the good and the bad... What is your profession??? do you have an oath? What kind of relationship do you have with a Veterinarian? What kind of questions do you ask? Do you go in and say "I want this and that?".. Just some thoughts from someone who has to deal with people like you.

Burkie in Kansas    
Abilene, Kansas  |  April, 12, 2012 at 11:59 AM

The Veterinarian's Oath. Revised. Does not mean a license to overcharge for prescribed medicines, sold by a veterinarian, to my way of thinking. An Oath is just that, a pledge to be available to help those of us who need veterinary services, without having to worry about being charged for maldiagnosis or maladvised prescriptions. The Oath declares one's responsibilities to diagnose and suggest alternatives to administer the "right and proper" antibiotics to combat bacterial or viral invasions that prevent the normal functioning of an animal and ensure the trust of an animal keeper is maintained for those of us that have animals that require more expert care than we may be able to provide, ourselves. FDA has managed now, to insure that might not occur in the future. It just plain costs too much. Feed grade antiobiotics by prescription will cost far more than some animals are worth. The Public will cipher this out, and realize it's just another increase in costs to have animals, or pets, at all. When it comes to large populations of farmed animals in a CAFO, this will mean that the only cost-affordable alternatives are to have contractual agreement for a veterinarian to prescribe right and proper antibiotics, which few veterinary establishments can presently do. Sending samples to a regional lab is expensive and time-consuming, the bugs and viruses work 24/7.

Steve    
Eastern Iowa  |  April, 12, 2012 at 03:03 PM

Luke,
You are an idiot. Unfortunately you know nothing about what goes into feeds other than the "PETA-type" publications. Arsenic...get real.

Maddee    
USA  |  April, 13, 2012 at 10:48 AM

This ruling will add stress to the already dwindling population of large animal vet throughout the the country.

Will more funding then go to the increase in the number of large animal vet programs and students int those programs currently?

Or should we refocus those dollars to human health to that continually abuses antibiotic use?

Glenn    
St. Louis, MO  |  April, 13, 2012 at 06:43 PM

Luke - You are going to have to substantiate your claim of "highly contributes to the proliferation of superbugs" for your comment to have any weight. This is exactly what this discussion on the larger scale is lacking. There have been assertions but no scientific link to your claim. Just because you keep repeating it does not make it true.

Bill Murray    
April, 14, 2012 at 03:33 PM

Reading all these comments is like listening to a bunch of 10 year olds. Based on the anger displayed by Luke and Burkie and if I were a Veterinarian in your area I would refuse to give you any service. A Veterinarian is not required to ever come to your places and if were a Vet. I wouldn't - figure it out on your own by yourself!!!

Maxine    
SD  |  April, 14, 2012 at 08:15 PM

Apparently the culture of 'hate what and whom you do not know' is growing by leaps and bounds in farm country!

And 'conspiracy of the month' clubs apparently gaining members daily.

Why can farmers not recognize that much of the antagonism against animal use antibiotics is agenda driven and not backed by real scientific evidence of harm, or of extreme over, or extra-label use?

Why can't others admit that over-use and careless use and disposal of antibiotics by/in'for PEOPLE is a factor, even in levels found in waterways (where city sewer systems empty)?

Not all farmers, nor agri-businesses are evil ogres cheating the consumer (the customer, for goodness sake!!!) and wringing the last penny in "evil profit" from the carcass of every food animal. HOWEVER, profit is necessary in order for there to be ANY food on grocery shelves. It does cost money to produce safe, nutritious, tasty food, and all people who are part of the system deserve to be paid for what we do. Often, the 'first' producer, the farmer/rancher, is the one who profits least, contrary to what too any people WANT to believe.