PRODUCERS FACE SCRUTINY FROM PUBLIC OVER ANTIBIOTIC FEEDING

by: Stephen B. Blezinger
PhD, PAS

Part 1

The use of antibiotics in food animal feeding has been a common practice for years. It has also been under fire from a variety of scientists, doctors, consumer groups and the media for years. The contention, dating back into the early 1970's, is that the sub-therapeutic feeding (feeding at levels to improve gain performance or feed efficiency, not to treat a disease) of antibiotics to livestock and poultry can potentially increase the resistance of certain bacteria in humans. Today we hear about “super bugs” such as methicillin-resistant Staphylococcus aureus (MRSA), which is a strain of staph bacteria that's become resistant to the antibiotics commonly used to treat ordinary staph infections. Many experts believe that the resistance this organism now shows to antibiotics is largely related to the ag industry's feeding of widely accepted antibiotics to cattle, swine and poultry. While it is known that there are a variety of antibiotic resistant bacteria that affect humans, when the research is thoroughly reviewed, the origin of this situation is less clear even though animal agriculture seems to be the primary target. It should be clarified that while all antibiotic use in food animal production is under fire (fed products as well as those injected for the therapeutic treatment of various infections and diseases), the primary group of concern are those being fed to animals.

Over the next couple of issues we will discuss the current status of this issue. We'll look at the history and evaluate the facts and fallacies. We'll start here by reviewing current events that are affecting this management practice and how it may very well affect cattle producers.

Government and Judiciary Involvement

The U. S. Government, particularly the Food and Drug Administration has long been involved in this issue, as it should be. And for the most part, in the past, it has overseen antibiotic use and provided reasonably non-invasive “guidance” to producers, veterinarians and nutritionists for use of these products in animal feeding settings.

More recently, however, the judiciary has found the need to direct the FDA to step up its efforts in this arena. On March 22, Reuters (http://www.reuters.com/article/2012/03/23/us-fda-antibiotics-idUSBRE82M04R20120323) reported that U.S. Magistrate Judge Theodore Katz ordered, in response to a lawsuit filed, for the U.S. Food and Drug Administration to begin proceedings unless makers of the drugs can produce evidence that their use is safe. If the drug manufacturers are unable to provide adequate proof then the FDA must withdraw approval for non-therapeutic use of those drugs, the judge ruled. The FDA had started such proceedings in 1977, prompted by its concerns up to this time that the widespread use in livestock feed of certain antibiotics - particularly tetracyclines and penicillin, the most common, may not be safe and that antibiotic resistance in bacteria affecting humans may result. At this time the proceedings were never completed and the approvals remained in place.

Katz stated: "In the intervening years, the scientific evidence of the risks to human health from the widespread use of antibiotics in livestock has grown, and there is no evidence that the FDA has changed its position that such uses are not shown to be safe."

The lawsuit was filed by environmental and public-health groups including The Natural Resources Defense Council, Center for Science in the Public Interest and the Union of Concerned Scientists in the Manhattan federal court in May 2010. In the suit, the plaintiffs argued that using common antibiotics in livestock feed has contributed to the rapid growth of antibiotic-resistant bacteria in both animals and humans. In their argument, the plaintiffs went on to claim that antibiotic-resistant infections cost Americans more than $20 billion each year citing a 2009 study from the Alliance for the Prudent Use of Antibiotics and Cook County Hospital.

In his ruling, Katz ordered the FDA to follow through on the process it started in 1977 but only formally abandoned in December last year. The FDA said the proceedings were outdated and that it intended to pursue other regulatory strategies for coping with potential food-safety problems. Katz went on to comment that "the FDA has not issued a single statement since the issuance of the 1977 notices that undermines the original findings that the drugs have not been shown to be safe."

An article in the Washington Post on April 11, 2012 by Dina El Boghdady reported that the Food and Drug Administration had finalized a plan that would ask drug companies to voluntarily limit the use of certain antibiotics in animal feed. The FDA cites long-held concerns that their overuse in livestock promotes the development of drug-resistant bacteria that can infect people. The report went on to point out that a number of antibiotics that are widely used to treat human illnesses, such as penicillin, are mixed with animal feed in some cases to increase growth rates and weight gain in food animals. It reported that the prevalence of antibiotics in livestock has been linked in several studies to the creation of drug-resistant “superbugs” that can spread to humans who eat, or even work with, the animals. However, no references were given to specific studies.

The FDA is asking drug manufacturers to stop using 200 products for growth promotion and instead to use them solely to treat and prevent diseases. Companies that opt to do so will be required to revise their product labels to reflect the change. A separate agency proposal would give the companies three months to detail their strategies and three years to adopt them.

Once the drugs are relabeled, those antibiotics would no longer be available to producers “over the counter,” as they are currently. Use of these products would require a prescription from a veterinarian. This has also been a long desired response desired by many (not all) in the veterinary community.

The FDA plan attempts to address a long debate about a widely recognized alleged public health hazard with global implications. As scientific evidence has mounted about the dangers of antibiotic resistance, the government has come under pressure to act swiftly. The voluntary path to regulation, supported by many in the drug industry, emerged as an efficient route to coping with the concerns, federal regulators have stated.

As with all issues of this nature, there are critics that argue that the government must place an outright ban on the use of antibiotics for growth promotion, as it proposed doing decades ago. As noted earlier in 1977, the FDA proposed banning the use of penicillin and two forms of tetracycline for growth promotion. But after massive resistance from the industry and Congress, the agency never held hearings or took further action. The Natural Resources Defense Council and four other health and consumer advocacy groups sued the government last year to prompt action.

So as a response to this suit and the judge's ruling, the FDA must now grant the drug makers an opportunity to appear at a hearing and prove that the antibiotics are safe. Subsequently, if, at the hearing, the drug sponsors fail to show that the use of the drugs is safe to the satisfaction of those hearing their arguments, the FDA Commissioner must issue a withdrawal order.

One concern FDA officials have noted is that with so many products approved for growth promotion, it would take decades of administrative proceedings and possibly litigation to withdraw each drug. One example of this is illustrated with the agency's effort to revoke approval of Baytril, an antibiotic used to treat chickens (among other applications). The government succeeded in banning that use in 2004, but only after five years of efforts. “This is the most expeditious way to get to the same result,” Michael Taylor, the FDA's deputy commissioner for foods, said of the government's plan, which was first proposed two years ago. He went on to state: “There is a real buy-in from the drug companies. They realize the time has come to make this shift.” This is yet to be seen.

The animal feed and antibiotic manufacturing industry now must direct its attention to the details of how this FDA plan will be put in place, devoting particular attention to the role veterinarians will play. Under the voluntary program, veterinarians will ultimately determine whether producers get access to the antibiotics they're seeking. The National Pork Producers Council said the plan “could be problematic, particularly for smaller producers or producers in remote areas who may not have regular access to veterinary services.” The group also said the plan could increase the cost of food. It could certainly have negative effects on animal performance (growth and health) which may put additional pressure on already tight profit margins. The agency is seeking comment on ways to modernize veterinary oversight. The Animal Health Institute, which represents companies that produce veterinary medicines, said it supports the new FDA program. But “there are details that must be addressed to make this approach practical and workable,” the group said in a statement.

The cattle industry has also weighed in on the issue. In a recent report from Drover's, Tom Talbot, a California beef producer, large animal veterinarian and current chairman of the NCBA's Cattle Health and Well-Being Committee commented: “NCBA raised concern with FDA's Guidance 209 in 2010 because the agency lacked the necessary science in its recommendations. 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 FDA working with the beef 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.

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

But while it appears that the FDA is attempting to take a cooperative approach with drug manufacturers and the food animal production industry, it will not come without pressure and opposition from those who desire a more substantial ruling. Advocates of stronger regulation of antibiotics in livestock expressed disappointment that the guidance relies on voluntary cooperation within the industry. Natural Resources Defense Council attorney Avinash Kar has 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."

Conclusions

So, we've seen it coming and the demand to reduce antibiotic use in food animal production many now finally face us first hand. The previous discussions have made apparent that the Federal Government is now moving to respond to pressure from those that have opposing views to antibiotic use in the animal production industries so we can prepare ourselves for the debates as well as the affects this will have on how we manage and produce beef, pork and poultry. In the next issue we will take a look at some back ground of this issue to better understand the science behind these concerns and allegations.

Dr. Steve Blezinger is a management and nutritional consultant with an office in Sulphur Springs, TX. He can be reached at sblez@verizon.net or at (903) 352-3475. For more information please visit us on at www.facebook/reveille livestock concepts.







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