Approximately 80 percent of all antibiotics used in the United States  are used in livestock.  Compared to the 3,000,000 pounds of antibiotics given to humans each year, 17,800,000 pounds of antibiotics are fed to livestock.  Jonathan Safran Foer in Eating Animals (New York, Little Brown and Co., 2009) notes that the Union of Concerned Scientists contends that the use of antibiotics in agriculture in the United States has been under-reported by 40 percent and calculates that approximately 24,600,000 pounds of antibiotics are used in agriculture in the United States on an annual basis.  Given to “healthy” animals in their feed or water at “subtherapeutic” levels (doses too low to treat disease), antibiotics important in human medicine have been used in industrial agriculture to prevent infections that tend to occur when animals are kept in cramped, unsanitary conditions and to promote faster growth of the “10 billion land animals slaughtered for food each year in the United States” (Jonathan Safran Foer’s Eating Animals).

The U.S. Food and Drug Administration (FDA) is charged with regulating the use of antibiotics in livestock.  Since the 1950s, it has approved the use of antibiotics in animal feed for nontherapeutic purposes, such as growth promotion and routine disease prevention.  The FDA in the mid 1950’s approved new animal drug applications (and abbreviated new animal drug applications with respect to generic drugs) (i) for penicillin to be used “to promote growth in chickens, turkeys and swine”, and (ii) for tetracyclines (i.e., chlortetracycline and oxytetracycline) to be used “to promote growth in chickens, turkey, swine, cattle, and sheep.”

The FDA determined in 1977 that these initial approvals, made in the mid 1950’s, should be modified or reversed because “certain subtherapeutic uses of penicillin and tetracyclines in animal feed were not shown to be safe,”  but more than three decades later, no effective action had been taken by the FDA.   According to a federal lawsuit brought by five nonprofit organizations, (1) the Natural Resources Defense Council, (2) Center for Science in the Public Interest, (3) Food Animal Concerns Trust, (4) Public Citizen, Inc., and (5) Union of Concerned Scientists, it has been 35 years since the FDA found that the subtherapeutic uses of penicillin and tetracyclines “were contributing to the development of antibiotic-resistant bacteria that could be transferred to humans.”  Moreover, these plaintiffs maintain that the FDA “has reiterated its findings in subsequent decades” yet has “never withdrawn its approvals for subtherapeutic uses of penicillin and tetracyclines.”  The effectiveness of antibiotics, the wonder drugs of the 20th century, is at risk by the mutating of bacteria  into strains resistant to antibiotics.

Decades later and only after the institution of this litigation, the FDA has now been directed to take action on the unsafe use of antibiotics in animal feed.  (In addition to the FDA, the plaintiffs named as defendants: (i) Margaret Hamburg, in her official capacity as Commissioner of the FDA; (ii) the Center for Veterinary Medicine, which is charged by the Food and Drug Act and its implementing regulations with withdrawing approval of new animal drugs that are not shown to be safe; (iii) Bernadette Dunham, in her official capacity as Director of the Center for Veterinary Medicine; (iv) United States Department of Health and Human Services; and (v) Kathleen Sebelius, in her official capacity as Secretary of Health and Human Services.

United States Magistrate Judge  Theodore H. Katz, granting the plaintiffs’ motion for summary judgment, has ordered the defendants to initiate withdrawal proceedings for the relevant penicillin and tetracycline new animal drug applications/ abbreviated new animal drug applications now decades old.  Judge Katz, in his thorough decision, noted that there was “never any reasonable effort” by the FDA to comply with specific terms of a consent decree, and he rejected the “false notion” that the FDA’s failure represented merely “a few technical violations.”   In particular, the judge focused on a multitude of problems with the FDA’s “manure management practices.”

Pursuant to the decision of Judge Katz, drug manufacturers will be provided with the opportunity at a hearing to prove that the use of penicillin and tetracycline (i.e., chlortetracycline and oxytetracycline) in feed is safe.   It is fair to predict that this burden of proof will be impossible to sustain by the drug manufacturers, especially in light of the recent issuance by the FDA of its Guidance for Industry #209, “The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals.”  This “guidance” for industry summarizes 18 key reports and 8 recent peer-reviewed scientific literature “related to the use of antimicrobial drugs in animal agriculture.”  It also “outlines FDA’s current thinking on strategies for assuring that medically important antimicrobial drugs are used judiciously in food-producing animals in order to help minimize antimicrobial resistance development.”  The “guidance” specifies two “Recommended Principles Regarding Judicious Use in Animals.”  Principle 1 provides: “The use of medically important anitmicrobial drugs in food-producing animals should be limited to those uses that are considered necessary for assuring animal health.”  Principle 2 provides: “The use of medically important antimicrobial drugs in food-producing animals should be limited to those uses that include verterinary oversight or consultation.”

In a later development in this complex litigation, Judge Katz issued a second memorandum and order, which addressed a third cause of action pertaining to two Citizen Petitions submitted by the plaintiffs to the FDA in 1999 and 2005 to rescind approvals for all nontherapeutic uses in livestock of antibiotics critical to human medicine [specifically naming erythromycin, lincomycin, tylosin and virginiamycin, in addition to penicillin and tetracyclines]. The two Citizen Petitions were finally denied by the FDA in November 2011.  According to plaintiff’s attorneys, Avinash Kar and Jennifer A. Sorenson, in denying the petitions, the FDA violated its “statutory duty to ban previously approved drug uses that are unsafe or not shown to be safe for human health . . . in favor of an unenforceable plea for industry cooperation (i.e., the Guidance for Industry #209).”  Plaintiffs vigorously assert that the “FDA’s issuance of nonbinding recommendations cannot excuse its failure, in response to the citizen petitions, to make safety findings and then to withdraw approval for animal drugs that are unsafe or not shown to be safe.”  Judge Katz agreed and rejected the FDA’s reasons for its refusal to initiate withdrawal proceedings.  The FDA’s justification for its denial of  the citizen petitions on the grounds  that (1) the time and expense required to evaluate individual drug safety and to hold formal withdrawal proceeding if necessary “would be too time-consuming and resource-intensive” and (2) that non-binding voluntary measures to promote the judicious use of antibiotics in food-producing animals would achieve the same result as formal withdrawal proceedings was, according to Judge Katz, “arbitrary and capricious.”  The judge noted that the FDA may not “abdicate its duty to ensure that the use of animal drugs is safe and effective,” and he emphasized that “nothing prevents the FDA from seeking voluntary cooperation from the drug industry, in tandem with a notice of intent to withdraw approval.”  In his second order, Judge Katz has directed the FDA to “evaluate the safety risks of the petitioned drugs and either make a finding that the drugs are not shown to be safe or provide a reasoned explanation as to why the Agency is refusing to make such a finding.”

Margaret Mellon, Senior Scientist with the Union of Concerned Scientists, noted that “This is a great victory for the public health.”  However, her hope that the FDA in response to the court orders will “move expeditiously on critical issues that have dragged on for far too long” is tempered by the FDA’s decision to appeal the orders by Judge Katz to the U.S. Second Circuit Court of Appeals in New York.

Jonathan Safran Foer in Eating Animals, includes, as one of the three main reasons why  the industrial agricultural model is not sustainable long-term, the antibiotic overuse in raising 450 billion land animals each year [the other two reasons: (1) farmed animals in the United States produce sewerage which is “30 times as much waste as the human population- roughly 87,000 pounds of shit per second and (2) the “profoundly cruel systems” which produce meat as a product].  He makes a strong case that industrial agriculture has externalized the costs for environmental degradation, human disease and animal suffering.  This litigation affirms Mr. Foer’s concerns by revealing the enormous effort that is required to ensure that a federal agency conforms to legal requirements in regulating the use of antibiotics in animal feed.   The provisions of laws to protect human health and the environment are meaningless if they are merely written on paper and not enforced.  The additional delay resulting from the FDA’s decision to appeal Judge Katz’s orders is frustrating given the decades of inaction in stopping the unsafe use of antibiotics in animal feed.  As noted in a very persuasive and succinct New York Times Editorial:
“The sea of drugs on farms creates a perfect environment for the evolution of pathogens resistant to antibiotics, which have been found in humans with increasing frequency.  And new studies show that drug-resistant germs persist even in the soil and groundwater of farms that have given up antibiotic use.  It’s time for the FDA to consider the public’s health as carefully as it considers the interests of intensive agriculture and pharmaceutical companies.”

(Natural Resources Defense Council, Inc., et al., v. United States Food and Drug Administration, et al., No. 11 CIV 3562 (THK), Memorandum Opinions and Orders dated March 22, 2012 and June 1, 2012, Judge Theodore H. Katz ). The plaintiffs were represented by Avinash Kar and Jennifer A. Sorenson, of San Francisco, California.  Downloadable copies of the two memorandum opinions and orders by Judge Katz are available on the website of the University of Tennesee’s Agricultural Policy Analysis Center.

(Frank W. Barrie,  8/01/12)

UPDATE:  A posting on August 8, 2012 on Avinash Kar’s Blog notes that the Federal appeals court rejected further delay in “regulatory proceedings for penicillin and tetracyclines use in livestock” and imposed the generous deadline of five years for the completion of the proceedings.  (FWB, 8/10/12)