FDA takes measures with antibiotic use in livestock

By Matt Reese

Every time anyone opens their mouth to take a bite food, they are taking a risk. But, as it turns out, not eating food is even riskier.

This game of risk is at play with the debate of antibiotic use and regulation in livestock and poultry. There is a current scientific debate about the ability of bacteria treated with antibiotics to develop resistance. Some of these “superbugs” that thwart treatment efforts have developed already and are a growing concern. In terms of livestock, preventive or “production” treatments are of particular concern because they are typically low doses that may more easily facilitate the development of resistance.

The U.S. Food and Drug Administration (FDA) is currently working through the vast and complex science of this issue in determining the risk levels of antibiotic use in livestock. There is no concrete proof that there is a significant risk involved with antibiotic use in livestock, but there is no proof that there is not, either. There are proven, and very significant, benefits with current antibiotic practices, and the FDA is scrutinizing all possible risks to see if they outweigh the benefits.

As a result, the FDA announced that it is taking three steps with regard to antibiotic use in livestock by publishing three documents in the Federal Register:

 

  • A final guidance for industry, “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  • A draft guidance, open for public comment, which will assist drug companies in voluntarily removing production uses of antibiotics from their FDA-approved product labels;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.

 

In a three-year timetable for phasing out antibiotics used to spur growth in food-producing animals, the FDA proposal relies largely on getting the livestock and drug industries to voluntarily cut their use. The plan calls for drug companies to stop using 200 drugs labeled for the promotion of growth and instead use them only to treat and prevent diseases.

Companies would be required to change their drug labeling by removing growth promotion as a valid use for antibiotics that are primarily given to livestock through feed. The re-labeled antibiotics would then no longer be available to farmers over the counter. Instead, a veterinarian would have to prescribe the medically important drugs.

Livestock industry critics of the measures generally feel that while there is nothing wrong with increased veterinary oversight, the changes will disproportionately affect small producers, have a negative effect on animal health and increase the cost of producing food while not improving public health.

Chuck Wildman has concerns with how the changes could affect business on his 650-sow Madison County farrow-to-finish operation.

“The devil is going to be in the details,” he said. “We have a veterinarian on the farm not less than every six weeks. We’ll see if we have to have the vet come out more often.”

Like the vast majority of livestock producers, Wildman takes great care to use antibiotics sparingly to treat problems in his hogs as needed.

“I have always used antibiotics as judiciously as possible for the treatment of diseases. They are expensive and you don’t use them without a reason,” he said. “The consumer wants a healthy animal and I want to present a healthy animal to the consumer. When you take away my ability to use antibiotics to get there, I’m not sure anybody has benefitted. The consumer is not receiving an unhealthy animal now with the way I use antibiotics. This will just add another challenge.”

Wildman fears the extra hoops to jump through will do little but add to the mountain of paperwork and regulation he already has to deal with.

“All these regulations add five minutes here and five minutes there. Pretty soon, I am going to run out of five minutes to work with, and I know it will be sooner than the paid staff of the larger farms,” Wildman said. “Any time you add a new a regulation, you hurt somebody. It is going to hurt the guy that will least be able to deal with it and that will be the smaller farmer.”

Dr. Leah Dorman, of the Ohio Farm Bureau’s Center for Food and Animal Issues, is a veterinarian who has closely followed the debates surrounding antibiotic use in livestock, also has some concerns with FDA action.

“The ‘Judicious Use of Medically Important Antimicrobial Drugs in Food Producing Animals’ has been out for awhile, but is now in its final form. Basically, it covers those drugs that are used in human medicine that we also use in food producing animals,” she said. “It limits these medically important antibiotics to uses that are considered necessary for assuring animal health, which means they can only be used for the prevention, control and treatment of disease. This phases out the production uses of these drugs such as ‘increased rate of weight gain’ or ‘improved feed efficiency.’ It also phases in veterinary oversight in the use of these drugs.”

For example, penicillin is labeled for treatment of disease and is currently an over the counter medication, but that could be changing.

“Because penicillin is used in human medicine, it is considered medically important and therefore would have to be used with the oversight of a veterinarian. So, this could mean you no longer will be able to run to the local elevator or feed mill to get penicillin because you will need a prescription,” Dorman said. “Although I see the value of having veterinary involvement, I worry about how these changes affect the small farms, as they are less likely to be able to afford or may not have access to a veterinarian. And, something to keep in mind is that two of these FDA documents are guidances, which puts in writing what the agency is thinking about regarding antibiotic usage in food producing animals. They are not legally enforceable responsibilities, yet. They certainly give a good idea of the regulations that might be coming in the future.”

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4 comments

  1. I am most interested in this line in your article:

    “There is no concrete proof that there is a significant risk involved with antibiotic use in livestock”.

    As I learn more and more about the confusion regarding research, I also learn that once in a while people speak clearly. To my mind, the FDA itself spoke very clearly in 1977. Judge Katz’ recent court ruling begins with this summary which I find pretty clear:

    “For over thirty years, the FDA has taken the position that the widespread use of certain antibiotics in livestock for purposes other than disease treatment poses a threat to human health. In 1977, the FDA issued notices announcing its intent to withdraw approval of the use of certain antibiotics in livestock for the purposes of growth promotion and feed efficiency, which the agency had found had not been proven to be safe.”

    This seems clear to me.

    The FDA also cites 12 pages worth of research findings in its recent guidelines that show concern for production level antibiotic use.

    This also seems clear to me.

    There is animal feed that contains antibiotics, correct? That is a clear indication that it is affordable and advantageous as a growth mechanism.

    Please help me understand what more concrete proof you’d like besides the FDA’s own repeated statements?

    • Concrete proof and concern are not the same things, not even close. Here is a response from Don “Doc” Sanders, a well-respected Ohio veterinarian on this issue:

      The citizens of the U.S. are very fortune to have a scientific governmental agency, the Food & Drug Administration (FDA) to evaluate practices that influence food safety and the prevention of antibiotic residues and antibiotic resistance. Most of the world does not have such an agency nor standards that can withstand the scrutiny of scientists and provide the our citizens with safe food. Most of Europe relies on popular opinion and a vote in parliament to determine food safety. In spite of 25 years of evaluating antibiotic usage and antibiotic resistance the FDA has determined there is only quasi circumstantial evidence that antibiotics used in growth promotion might be an issue for humans.

      Because of the policy of erring on the side of human safety, the FDA has established regulations prohibiting the antibiotics used to treat humans from being used at sub-therapeutic levels in animals. None! Na-Da! Read my lips – prohibited!

      Activists that would have you believe otherwise have other motives or are on wacky weed. April the 4th, 2012, the FDA has further limited the use of even therapeutic uses of antibiotics in food animals. In addition the new regs have established zero tolerance levels for certain classes of antibiotics that previously were permitted to be prescribed by a veterinarian for specific disease issues when other antibiotics weren’t effective.

      There are a few classes of antibiotics that are permitted to be used for sub-therapeutic use to promote growth performance and health in animals. The FDA has continued to review the data on these practices but hasn’t arrived at any conclusions which resulted in new regulations. These growth enhancers do make food production more efficient resulting in lower cost food to the consumer (Although current food prices do strain the credibility of that statement.)

      Antibiotic resistance is a much more serious problem because of the number of physicians that prescribe antibiotics for colds, teenage acne and every other non-descript ailment. In defense of doctors, patients often expect and demand an antibiotic for whatever ails them. Each of these issues add considerable weight to the concerns about antibiotic resistance.

      Recently bacteria detected and isolated from 4 million years ago were determined to have the “R” factor for antibiotic resistant. This makes the water far more murky. Evidence suggests we didn’t exist or have antibiotics 4 million years ago!

      Denmark nearly 10 years ago banned all antibiotics used in sub-therapeutic growth promotion for the Danish pork industry. The interesting fact is now they have one of the highest incidences of MRSA (methicillin-resistant Staph aureus) after banning sub-therapeutic antibiotic use in animals. Are these two issues related? I don’t know but I do know that making major health changes in policy often causes unintended consequences.

      Every swine farmer producing meat products are under one of the strictest set of standards for production of pork, animal welfare and prevention of antibiotic residues in meat. This program is named Pork Quality Assurance Plus. It is a national certifying standard to assure the quality management standards for raising pigs. In addition swine farmers have specific guidelines for prevention of antibiotic residues in pork, disease control standards as well as established quality animal welfare care standards for pig rearing.

      Now all major packers refuse to purchase pigs from pork farmers unless they have been certified as meeting the standards of Pork Quality Assurance Plus. If pork is purchased from an unfamiliar source by a consumer, it is useful to determine if this meat provider/ producer has been certified as meeting the standards of Pork Quality Assurance Plus. Generally the major brands such as Tyson, Cargill and Hormel can’t afford to have their name besmirched. Therefore the large pork producers are likely to have the highest quality products with policies and audits to verify their products meet that standard. Granted there are some small niche markets that are equally conscientious so don’t cast aspersions on small operations.

      Here is another example that involves hormones in food – another hot topic. Dairy farmers formerly administered bovine growth hormone (rBST) to cows for improved efficiency. Generally cows produced 8% more milk on the same amount of feed prior to the increased production. Administering rBST improved a cow’s efficiency and profitability for dairy farmers but this was also good for the environment because it meant lower input costs. It was the equivalent of taking 441,000 cars off the road for each one million cows that received rBST!!!!!! It took some time when rBST was introduced in Feb,1994 for dairymen to adapt with sharpened management skills for these cows but it did happen. Again activists promoted the story that it was putting rBST into the milk and consumers should not drink it. Grocers were ambivalent to the claims. Because they could receive a higher price for a gallon of milk, the grocers started labeling milk from cows not receiving rBST as “hormone free” which of course isn’t true because all milk contains hormones. Eventually grocers declined to purchase milk from cows receiving rBST. Today there are very few places in the U.S. that permits dairymen to utilize this technology to improve production efficiency, reduce dairying’s carbon footprint and improve profits.

      Give me milk from a cow that has not received BST. Her milk will contain 1 ng. (.0000000001 gm) of growth hormone.

      Give me milk from a cow that has received BST. Her milk will contain 1 ng. (.0000000001 gm) of growth hormone.

      Give me milk from a mother nursing her baby. Her milk will contain 1 ng. (.0000000001 gm) of growth hormone.

      The baby receiving cow’s milk digests the bovine growth hormone in its stomach with no impact on the baby. The growth hormone from mom’s milk isn’t digested but is absorbed promoting a stronger immune system as well as a number of growth factors that stimulate growth and normal neonatal development.

      Provide me with a steak from a prime grade steer and its meat will contain 1.59 ng (.00000000159 gm) of estradiol (estrogen hormone).
      Provide me with a steak from a prime grade steer that received a growth hormone implant to promote greater muscling and feed efficiency and its meat will contain 1.86 ng (.00000000186 gm) of estradiol.

      Provide me with a tossed salad with garden greens and it contains 12,000 ng of estradiol.

      Let me drink soy milk which contains 36,000 ng of estradiol.

      Birth control pills using estradiol contain three times as much estradiol as drinking soy milk.

      The world is full of junk science which doesn’t merit being aired in the light of day that activists use to promote an agenda. Unfortunately the unsuspecting public has only what the media prints or broadcasts to learn about the issues. Those pundits are more interested in selling newspapers or drawing more viewership that providing a public service. About the only good thing by the media in 2012 is this is an election year with bigger fish for them to fry to promote ratings rather than stirring up nonsense in the food safety world.

      Respectfully,

      Donald E. Sanders D.V.M., Dip. ACT, PAS
      Associate Professor, Clinical
      The Ohio State University Large Animal Field Service
      Marysville, OH 43040

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