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LEGISLATION

Phase-out of nontherapeutics
KAW strongly supports bipartisan bills, introduced by Senator Ted Kennedy (D-MA) and Olympia Snowe (R-ME) (S. 1460) and Representatives Sherrod Brown (D-OH) and Wayne Gilchrest (R-MD) (H.R. 2932), to phase out "nontherapeutic" use (i.e., routine use in livestock and poultry that are not sick) of medically important antibiotics as feed additives. (See the bill summary.) More than 300 organizations have previously endorsed similar measures, including the American Medical Association, American Public Health Association, and numerous other medical, public health, environmental, sustainable agriculture, and other groups.

Fluoroquinolones and the School Lunch Program
On November 7, 2003 the Senate adopted Senator Hillary Rodham Clinton's (D-NY) amendment banning the purchase of chickens treated with fluoroquinolone antibiotics for the federal school lunch program. Her amendment was to the United States Department of Agriculture (USDA) FY 2004 appropriations bill. While the House initially had no comparable provision, Representative Sherrod Brown (D-OH) led the fight to reach a legislative compromise. The text of this final compromise, which was finally agreed to in January 2004, is in the letter that Rep. Brown and Senator Clinton sent in February to USDA, urging that it comply with Congress' instructions and stop buying such chickens for the school lunch program.

FEDERAL AGENCIES

Overview
In January 2001, a federal multi-agency task force issued "A Public Health Action Plan to Combat Antimicrobial Resistance." While the report correctly recognizes the severity of the antibiotic-resistance problem, its recommendations relating to use of antibiotics in agricultural animals were disappointingly limited. The Centers for Disease Control (CDC) helps administer the National Antimicrobial Resistance Monitoring System (NARMS), a monitoring program that gathers data on how prevalent antibiotic resistance is among a handful of different bacteria. NARMS collects bacteria both from human samples as well as from food-animal samples. Although CDC has considerable expertise on antibiotic resistance including agricultural aspects of the problem, it does not have regulatory authority over the issue.

Antibiotics cannot be marketed for use in animals in the U.S. without prior approval by the Food and Drug Administration (FDA). The Environmental Protection Agency (EPA) also has some authority to regulate the management of manure and other waste emitted from confined animal feeding operations, which commonly contains antibiotics and antibiotic-resistant bacteria.

Food and Drug Administration
Within FDA, the Center for Veterinary Medicine oversees the use of animal antibiotics. FDA has statutory authority to withdraw approval for an agricultural antibiotic to be marketed if there is information showing that the drug "is not shown to be safe" (21 U.S.C. §360b(e)(1)(B)), but it has never exercised this authority for an antibiotic. In 1977, FDA proposed to restrict nontherapeutic use of penicillin and tetracyclines. Before FDA could act, however, Congress directed the National Academy of Sciences to study the issue. The Academy concluded that then-available information was insufficient to reach a conclusion about whether nontherapeutic use of these drugs in animals was safe or harmful. FDA did not follow up on its own proposal, and took no further steps toward restricting agricultural use of antibiotics for some 20 years.

In the late 1990s, FDA began to re-engage on antibiotic-resistance issues in animal agriculture. Actions the agency has taken in the last few years include issuing several general policy documents and proposing to ban use in poultry of Cipro-like (fluoroquinolone) antibiotics.

FDA Policy Documents
  • In September 2002, FDA issued a draft guidance document describing a methodology for evaluating how agricultural use of antibiotics may impact human health via antibiotic resistance. The document is primarily intended to provide information to drug manufacturers about a process for seeking FDA approval to bring a new antibiotic to market for agricultural use, but it also has an Appendix in which FDA states that it intends to begin reviewing the safety of already-approved antibiotics. Both KAW and several of its member organizations submitted comments on the document. Those comments were supportive of the overall approach but urged that it be strengthened to better protect public health in several ways – most importantly by setting forth a specific schedule for reviewing already-approved antibiotics.
  • The draft guidance document implicitly superceded the so-called “Thresholds” document that FDA had issued in draft form in December 2000. That document, titled "An Approach for Establishing Thresholds in Association with the Use of Antimicrobial Drugs in Food-Producing Animals," proposed that new agricultural antibiotics could be approved and used until resistance to them exceeded a particular threshold level. Several public-interest groups submitted comments challenging the effectiveness of the proposed approach, which totally failed to address the problem of antibiotics with existing approval for use in agriculture.
  • The Thresholds document in turn elaborated on the FDA’s 1999 proposed “framework” for how the agency would consider applications for new antibiotics to be used in food animals. The document, titled "Proposed Framework for Evaluating and Assuring the Human Safety of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food Producing Animals" (64 Fed. Reg. 887, Jan. 6, 1999) had two major components: (1) it described a pre-approval system under which FDA will consider the potential of new uses of antibiotics in animal agriculture to exacerbate problems of antibiotic resistance in human pathogens, and (2) it outlined requirements for post-approval studies and monitoring of resistance levels for new uses of antibiotics in animal agriculture. Public-interest organizations filed comments stating "the proposed Framework is extremely weak and needs to be substantially revised in order to protect the efficacy of antibiotics vital to human health." Among other weaknesses, the Framework did not directly address the serious problem of antibiotics already approved for use in animal agriculture.
  • In October 2003, FDA released its Final Guidance to Industry #152, a nonbinding document which lays out the agency’s current thinking on use of medically important antimicrobial new animal drugs with respect to potential adverse impacts on human health. Applying the Guidance's criteria to existing uses of medically important antibiotics as feed additives indicates that such most uses are presumptively impermissible. However, the Guidance fails to establish a timeline for re-evaluating existing approvals of these drugs.
Fluoroquinolones and the FDA
In October 2000, FDA proposed to ban fluoroquinolone antibiotics from use in treating sick poultry. Fluoroquinolones also are critically important for treating severe cases of certain food borne illness in humans. The FDA proposal is based on evidence and a risk assessment showing that fluoroquinolone use in poultry is contributing to the dramatic recent rise in resistance to these important drugs in human medicine. The medical community strongly supported FDA’s proposal, as did the public interest community. Abbott Laboratories, maker of one fluoroquinolone product for poultry, complied with FDA's proposal, withdrawing the product from the market. However, Bayer Corp., the sole remaining manufacturer of the poultry drug, demanded a formal hearing. Initial documents were submitted to the hearing officer on December 9, 2002, including testimony by McDonald’s Corporation noting that its US suppliers have been able to discontinue use of fluoroquinolones with “no change in the quality, taste, price, or consumer acceptance of its chicken products.” Final papers were submitted by the parties in August 2003, and the Administrative Law Judge issued his decision on March 16, 2004, upholding the FDA's proposed ban. Read a KAW summary of the 68-page decision. Bayer plans to appeal the decision to the FDA commissioner and could appeal that decision to the federal courts. Thus the process could take several more years to complete.

Environmental Protection Agency
The EPA has authority over water pollutants, and in January 2001 proposed to regulate runoff from industrial-scaled livestock operations, or CAFOs. Public-interest groups filed comments noting that EPA had failed to address issues of antibiotics and antibiotic-resistant bacteria in its proposal. Regrettably, the final rules also failed to address the issue. KAW member groups have filed suit challenging the rule.

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updated 3/26/04