II 110th CONGRESS 1st Session S. 549 IN THE SENATE OF THE UNITED STATES February 12, 2007 Mr. Kennedy (for himself, Ms. Snowe, Mr. Reed, and Mr. Brown) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend the Federal Food, Drug, and Cosmetic Act to preserve the effectiveness of medically important antibiotics used in the treatment of human and animal diseases.

1.

Short title; table of contents

(a)

Short title

This Act may be cited as the Preservation of Antibiotics for Medical Treatment Act of 2007. (b)

Table of contents

The table of contents of this Act is as follows: Sec. 1. Short title; table of contents. Sec. 2. Findings. Sec. 3. Purpose. Title I—Safety of critical antimicrobial animal drugs Sec. 101. Proof of safety of critical antimicrobial animal drugs. Title II—Use of critical antimicrobial animal drugs in agriculture Sec. 201. Assistance to defray expenses of livestock or poultry producers in phasing out nontherapeutic use of critical antimicrobial animal drugs. Sec. 202. Research and demonstration programs. Sec. 203. Collection of data on critical antimicrobial animal drugs.

2.

Findings

Congress finds that— (1)(A)in January 2001, a Federal interagency task force released an action plan to address the continuing decline in effectiveness of antibiotics against common bacterial infections, referred to as antibiotic resistance; (B)the task force determined that antibiotic resistance is a growing menace to all people and poses a serious threat to public health; and (C)the task force cautioned that if current trends continue, treatments for common infections will become increasingly limited and expensive, and, in some cases, nonexistent; (2)antibiotic resistance, resulting in a reduced number of effective antibiotics, may significantly impair the ability of the United States to respond to terrorist attacks involving bacterial infections or a large influx of hospitalized patients; (3)(A)any overuse or misuse of antibiotics contributes to the spread of antibiotic resistance, whether in human medicine or in agriculture; and (B)recognizing the public health threat caused by antibiotic resistance, Congress took several steps to curb antibiotic overuse in human medicine through amendments to the Public Health Service Act (42 U.S.C. 201 et seq.) made by section 102 of the Public Health Threats and Emergencies Act (114 Stat. 2315), but has not yet addressed antibiotic overuse in agriculture; (4)in a March 2003 report, the National Academy of Sciences stated that— (A)a decrease in antimicrobial use in human medicine alone will have little effect on the current situation; and (B)substantial efforts must be made to decrease inappropriate overuse in animals and agriculture; (5)(A)an estimated 70 percent of the antibiotics and other antimicrobial used in the United States are fed to farm animals for nontherapeutic purposes, including— (i)growth promotion; and (ii)compensation for crowded, unsanitary, and stressful farming and transportation conditions; and (B)unlike human use of antibiotics, these nontherapeutic uses in animals typically do not require a prescription; (6)(A)many scientific studies confirm that the nontherapeutic use of antibiotics in agricultural animals contributes to the development of antibiotic-resistant bacterial infections in people; (B)the periodical entitled Clinical Infectious Diseases published a report in June 2002, based on a 2-year review by experts in human and veterinary medicine, public health, microbiology, biostatistics, and risk analysis, of more than 500 scientific studies on the human health impacts of antimicrobial use in agriculture; and (C)the report recommended that antimicrobial agents should no longer be used in agriculture in the absence of disease, but should be limited to therapy for diseased individual animals and prophylaxis when disease is documented in a herd or flock; (7)(A)the United States Geological Survey reported in March 2002 that antibiotics were present in 48 percent of the streams tested nationwide; and (B)almost half of the tested streams were downstream from agricultural operations; (8)an April 1999 study by the General Accounting Office concluded that resistant strains of 3 microorganisms that cause food-borne illness or disease in humans—Salmonella, Campylobacter, and E. coli—are linked to the use of antibiotics in animals; (9)(A)in January 2003, Consumer Reports published test results on poultry products bought in grocery stores nationwide showing disturbingly high levels of Campylobacter and Salmonella bacteria that were resistant to antibiotics used to treat food-borne illnesses; and (B)further studies showed similar results in other meat products; (10)in October 2001, the New England Journal of Medicine published an editorial urging a ban on nontherapeutic use of medically important antibiotics in animals; (11)(A)in 1999, the European Union banned the practice of feeding medically important antibiotics to animals other than for disease treatment or control, and prior to that, individual European countries had banned the use of specific antibiotics in animal feed; and (B)those countries have experienced no significant impact on animal health or productivity, food safety, or meat prices, and more importantly, levels of resistant bacteria have declined sharply; (12)in 1998, the National Academy of Sciences noted that antibiotic-resistant bacteria generate a minimum of $4,000,000,000 to $5,000,000,000 in costs to United States society and individuals yearly; (13)a year later, the National Academy of Sciences estimated that eliminating the use of all antibiotics as feed additives would cost each American consumer less than $5 to $10 per year; (14)the American Medical Association, the American Public Health Association, the National Association of County and City Health Officials, and the National Campaign for Sustainable Agriculture, are among the more than 300 organizations representing health, consumer, agricultural, environmental, humane, and other interests that support enactment of legislation to phase out nontherapeutic use in farm animals of medically important antibiotics; (15)the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)— (A)requires that all drugs be shown to be safe before the drugs are approved; and (B)places the burden on manufacturers to account for health consequences and prove safety; (16)(A)the Food and Drug Administration recently modified the drug approval process for antibiotics to recognize the development of resistant bacteria as an important aspect of safety; (B)however, most antibiotics currently used in animal production systems for nontherapeutic purposes were approved before the Food and Drug Administration began giving in-depth consideration to resistance during the drug-approval process; and (C)the Food and Drug Administration has not established a schedule for reviewing those existing approvals; (17)(A)the Food and Drug Administration has begun a process of evaluating the safety of antibiotics used in animal agriculture; and (B)that process— (i)is a valuable contribution to public health; and (ii)may determine that there is a reasonable certainty of no harm from the use of certain antibiotics in animal agriculture; (18)(A)an April 2004 study by the General Accounting Office concluded that Federal agencies do not collect the critical data on antibiotic use in animals that they need to support research on human health risks; and (B)the report recommends that the Department of Agriculture and the Department of Health and Human Services develop and implement a plan to collect data on antibiotic use in animals; and (19)certain nonroutine uses of antibiotics in animal agriculture to prevent animal disease are legitimate.

3.

Purpose

The purpose of this Act is to preserve the effectiveness of medically important antibiotics used in the treatment of human and animal diseases by phasing out use of certain antibiotics for nontherapeutic purposes in food-producing animals.