I 
108TH CONGRESS 
1ST SESSION H. R. 2932
To amend the Federal Food, Drug, and Cosmetic Act to preserve the effective-
ness of medically important antibiotics used in the treatment of human 
and animal diseases. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 25, 2003
Mr. BROWN of Ohio (for himself, Mr. GILCHREST, Ms. SLAUGHTER, Mr. 
WAXMAN, and Mr. ALLEN) introduced the following bill; which was re-
ferred to the Committee on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
preserve the effectiveness of medically important anti-
biotics used in the treatment of human and animal dis-
eases.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Preservation of Antibiotics for Medical Treatment Act of 
2003’’. 
(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. Collection of data on critical antimicrobial animal drugs produced for 
agricultural use.
SEC. 2. FINDINGS. 
The 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 re-
sistance 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 im-
pair 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 con-
tributes to the spread of antibiotic resistance, wheth-
er 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 
(Public Law 106–505, title I; 114 Stat. 2315), but 
has not yet addressed antibiotic overuse in agri-
culture; 
(4) in a March 2003 report, the National Acad-
emy 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 anti-
biotics and other antimicrobial drugs used in the 
United States are fed to farm animals for nonthera-
peutic purposes, including—
(i) growth promotion; and
(ii) compensation for crowded, unsanitary, 
and stressful farming and transportation condi-
tions; and 
(B) unlike human use of antibiotics, these non-
therapeutic uses in animals typically do not require 
a prescription; 
(6)(A) many scientific studies confirm that the 
nontherapeutic use of antibiotics in agricultural ani-
mals contributes to the development of antibiotic-re-
sistant 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) the United States Geological Survey re-
ported in March 2002 that—
(A) 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 Ac-
counting Office concluded that resistant strains of 3 
microorganisms that cause food-borne illness or dis-
ease 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 Jour-
nal of Medicine published an editorial urging a ban 
on nontherapeutic use of medically important anti-
biotics in animals; 
(11)(A) in 1999, the European Union banned 
the practice of feeding medically important anti-
biotics 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 signifi-
cant 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 Amer-
ican 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 rep-
resenting health, consumer, agricultural, environ-
mental, humane, and other interests that support 
enactment of legislation to phase out nontherapeutic 
use in farm animals of medically important anti-
biotics;
(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 safe-
ty; 
(16)(A) the Food and Drug Administration re-
cently modified the drug approval process for anti-
biotics to recognize the development of resistant bac-
teria as an important aspect of safety; 
(B) however, most antibiotics currently used in 
animal production systems for nontherapeutic pur-
poses were approved before the Food and Drug Ad-
ministration 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; and 
(17) certain non-routine uses of antibiotics in 
animal agriculture are legitimate to prevent animal 
disease. 
SEC. 3. PURPOSE. 
The purpose of this Act is to preserve the effective-
ness of medically important antibiotics used in the treat-
ment of human and animal diseases by phasing out use 
of certain antibiotics for nontherapeutic purposes in food-
producing animals. 
TITLE I—SAFETY OF CRITICAL 
ANTIMICROBIAL ANIMAL DRUGS 
SEC. 101. PROOF OF SAFETY OF CRITICAL ANTIMICROBIAL 
ANIMAL DRUGS. 
(a) DEFINITIONS.—Section 201 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321) is amended by 
adding at the end the following: 
‘‘(nn) CRITICAL ANTIMICROBIAL ANIMAL DRUG.—
The term ‘critical antimicrobial animal drug’ means a 
drug that—
‘‘(1) is intended for use in food-producing ani-
mals; and 
‘‘(2) is composed wholly or partly of—
‘‘(A) any kind of penicillin, tetracycline, 
bacitracin, 
macrolide, 
lincomycin, 
streptogramin, aminoglycoside, or sulfonamide; 
or 
‘‘(B) any other drug or derivative of a 
drug that is used in humans or intended for use 
in humans to treat or prevent disease or infec-
tion caused by microorganisms.
‘‘(oo) NONTHERAPEUTIC USE.—The term ‘nonthera-
peutic use’, with respect to a critical antimicrobial animal 
drug, means any use of the drug as a feed or water addi-
tive for an animal in the absence of any clinical sign of 
disease in the animal for growth promotion, feed effi-
ciency, weight gain, routine disease prevention, or other 
routine purpose.’’. 
(b) APPLICATIONS PENDING OR SUBMITTED AFTER 
ENACTMENT.—Section 512(d)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360b(d)(1)) is amend-
ed—
(1) in the first sentence—
(A) in subparagraph (H), by striking ‘‘or’’ 
at the end; 
(B) by redesignating subparagraph (I) as 
subparagraph (J); and 
(C) by inserting after subparagraph (H) 
the following: 
‘‘(I) with respect to a critical antimicrobial 
animal drug or a drug of the same chemical 
class as a critical antimicrobial animal drug, 
the applicant has failed to demonstrate that 
there is a reasonable certainty of no harm to 
human health due to the development of anti-
microbial resistance that is attributable, in
whole or in part, to the nontherapeutic use of 
the drug; or’’; and 
(2) in the second sentence, by striking ‘‘(A) 
through (I)’’ and inserting ‘‘(A) through (J)’’. 
(c) PHASED ELIMINATION
OF NONTHERAPEUTIC 
USE IN ANIMALS OF CRITICAL ANTIMICROBIAL ANIMAL 
DRUGS IMPORTANT FOR HUMAN HEALTH.—Section 512 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360b) is amended by adding at the end the following: 
‘‘(q) PHASED ELIMINATION OF NONTHERAPEUTIC 
USE IN ANIMALS OF CRITICAL ANTIMICROBIAL ANIMAL 
DRUGS IMPORTANT FOR HUMAN HEALTH.—
‘‘(1) APPLICABILITY.—This subsection applies 
to the nontherapeutic use in a food-producing ani-
mal of a drug—
‘‘(A)(i) that is a critical antimicrobial ani-
mal drug; or 
‘‘(ii) that is of the same chemical class as 
a critical antimicrobial animal drug; and 
‘‘(B)(i) for which there is in effect an ap-
proval of an application or an exemption under 
subsection (b), (i), or (j) of section 505; or 
‘‘(ii) that is otherwise marketed for use. 
‘‘(2) WITHDRAWAL.—The Secretary shall with-
draw the approval of a nontherapeutic use in food-
producing animals described in paragraph (1) on the 
date that is 2 years after the date of enactment of 
this subsection unless—
‘‘(A) before the date that is 2 years after 
the date of the enactment of this subsection, 
the Secretary makes a final written determina-
tion that the holder of the approved application 
has demonstrated that there is a reasonable 
certainty of no harm to human health due to 
the development of antimicrobial resistance that 
is attributable in whole or in part to the non-
therapeutic use of the drug; or 
‘‘(B) before the date specified in subpara-
graph (A), the Secretary makes a final written 
determination under this subsection, with re-
spect to a risk analysis of the drug conducted 
by the Secretary and other relevant informa-
tion, that there is a reasonable certainty of no 
harm to human health due to the development 
of antimicrobial resistance that is attributable 
in whole or in part to the nontherapeutic use of 
the drug. 
‘‘(3) EXEMPTIONS.—Except as provided in 
paragraph (5), if the Secretary grants an exemption 
under section 505(i) for a drug that is a critical