FDA Withdraws Longstanding Petition to Regulate Antibiotics in Livestock Feed

The U.S. Food and Drug and Administration announced only days before Christmas that it has decided to back off a 34-year attempt to regulate the use of antibiotics in livestock feed for animals intended for human consumption, despite mounting scientific evidence that has linked the practice to the development of potentially fatal antibiotic-resistant superbugs in humans.

With no other notice aside from an obscure posting in the Federal Register on Dec. 22, the FDA declared it will now focus on encouraging voluntary reform within the industry instead of enforcing actual regulatory action, in addition to the promotion of the judicious use of antimicrobials in the interest of public health. The agricultural industry began administering livestock feed with small doses of antibiotics in the 1950s, not to treat sick animals, but to attack bacteria that animals' would typically expend energy to fight off. Consuming low-levels of antibiotics allows livestock to fatten up faster and more efficiently, from a producers point of view.

The practice is often used by large-scale factory farmers, even though scientific literature dating from 1960s has connected it with the emergence of antibiotic-resistant bacteria that is hazardous to human health. The FDA acknowledged that risk in its original 1977 Notice of Opportunity for a Hearing to withdraw penicillin from animal feeds, where it warned that animals that have received either subtherapeutic and/or therapeutic amounts of antibiotic and sulfonamide drugs in feeds may serve as a reservoir of antibiotic resistant pathogens and non-pathogens. These reservoirs of pathogens can produce human infections.

Later that year, the agency submitted an additional NOOH to withdraw the antibiotic tetracycline from animal feeds as well. Those are the notices the FDA withdrew on Dec. 22, after spending more than 30 years in virtual limbo on the issue.

A combination of opposition from the agricultural industry, lobbying and lack of funding has kept the FDA from following through on its intention to regulate growth-promoting antibiotics in large-scale agriculture, even as scientists report that antibiotic use in animal agriculture has continued to rise.

Reports of Contaminated Meat Prevalent in 2011

The consequences are already apparent. A report published in the April 2011 edition of Clinical Infectious Diseases found that nearly half of 136 samples -- coming from 80 different brands -- of beef, turkey, pork and chicken from grocery stores across the nation were contaminated with multi-drug resistant strains of the bacteria Staphylococcus aureus. The bacteria, according to the report, has been linked with the development of rashes, sepsis, endocarditis and pneumonia.

In response, U.S. Department of Argiculture spokesman said the study's relevance to human health is unclear, while the American Meat Institute issued a statement saying the study's scientific sample was too small to reach the sweeping conclusions conveyed by the authors.

In April of last year, Jennie-O was forced to recall almost 55,000 pounds of ground turkey burgers after drug-resistant salmonella was found in its products, with Cargill following suit in August after being linked with a nationwide outbreak of salmonella sickness. One person died and at least 76 were sickened as a result of the Cargill contamination, The New York Times reported.

A coalition of medical and public health groups referred to the increase in salmonella outbreaks, as well as an abundance of other scientific studies and U.S. government reviews, in a September 2011 letter urging federal authorities -- including the FDA, the U.S. Centers of Disease Control and President Obama's Chief of Staff William Daley -- to take action on the issue.

The evidence is so strong of a link between misuse of antibiotics in food animals and human antibiotic resistance that FDA and Congress should be acting much more boldly and urgently to protect these vital drugs for human illness. In fact, government data show that the vast majority of antibiotics in the U.S. are sold for use in food animals, not people, the letter states.

In 2009, the FDA itself reported that 70 to 80 percent of antibacterial drugs in the U.S. were sold for use in livestock animals to promote growth, prevent disease and treat illnesses caused by unsanitary conditions.

Multiple Groups Sue FDA for Not Curtailing Antibiotic Use

While it may seem strange that the FDA suddenly decided to withdraw its petition urging regulation after keeping it on the back-burner for more than 30 years, Avinash Kar, a staff attorney with the Natural Resources Defense Council, told the International Business Times the agency likely did it in reaction to a lawsuit filed by a coalition of organizations in May 2011.

We think the FDA is supposed to protect people's food and human health. What they're doing is only resolving us toward pursuing our suit, Kar said, describing the FDA's NOOH withdrawal as a step backwards.

The lawsuit, filed by the NRDC along with the Center for Science in the Public Interest, Food Animal Concerns Trust, Public Citizens and the Union of Concerned Scientists, claims the FDA has failed to meet its legal responsibility to address the escalating health threat posed by the rise of drug-resistant infections linked to the overuse of antibiotics in animal feed, a move the NRDC said in especially heinous since the agency itself acknowledged the threats posed by the practice in 1977.

By withdrawing the original 1977 notice, the FDA may be attempting to remove the entire pretense for the NRDC lawsuit, Kar said.

Once the FDA made that finding, we believe the law required them to remove approval for those antibiotics in animal feed, Kar said.

The NRDC lawsuit also called for the FDA to respond to two citizen petitions filed by some of the plaintiffs in 1999 and 2005. The agency quickly denied the petitions once the lawsuit was filed, after ignoring them for years.

In addition to running counter to the FDA's own research, current FDA Commissioner Margaret Hamburg published scientific literature also warning of the threat posed by the development of antibiotic-resistant bacteria as the result of animal livestock's excessive consumption of antibiotics. In 2003, while serving as the Vice President for Biological Problems for the Nuclear Threat Initiative, Hamburg co-authored Microbial Threats to Health: Emergence, Detection and Response, which names drug-resistant bacteria as one of several infectious diseases that could hypothetically cause a global health hazard.

The FDA did not return multiple requests for comment regarding Hamburg's previous stance on the issue.

FDA Notice Leaves Room for Future Change

While the Dec. 22 notice in the Federal Register has effectively allowed the agricultural industry to pursue its questionable business model despite scientific warnings, the FDA emphasized the action should not be interpreted as a sign that GFA no longer has safety concerns or that FDA will not consider re-proposing withdrawal proceedings in the future, if necessary.

Some suspect the language indicates the FDA may be delaying real action on the issue until after the 2012 election, which Mother Jones' Tom Philpott writes is an effort to keep meat-industry 'dark money' from flowing to President Obama's opponent.