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: 
‘‘(rr) 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, 
macrolide, 
lincosamide, 
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. 
‘‘(ss) 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 
antimicrobial animal drug, the Secretary shall re-
scind each approval of a nontherapeutic use in a 
food-producing animal of the critical antimicrobial 
animal drug, or of a drug in the same chemical class 
as the critical antimicrobial animal drug, as of the 
date that is 2 years after the date on which the Sec-
retary grants the exemption. 
‘‘(4) APPROVALS.—Except as provided in para-
graph (5), if an application for a drug that is a crit-
ical antimicrobial animal drug is submitted to the 
Secretary under section 505(b), the Secretary shall 
rescind each approval of a nontherapeutic use in a 
food-producing animal of the critical antimicrobial 
animal drug, or of a drug in the same chemical class 
as the critical antimicrobial animal drug, as of the 
date that is 2 years after the date on which the ap-
plication is submitted to the Secretary. 
‘‘(5) EXCEPTION.—Paragraph (3) or (4), as the 
case may be, shall not apply if— 
‘‘(A) before the date on which approval 
would be rescinded under that paragraph, the 
Secretary makes a final written determination 
that the holder of the application for the ap-
proved nontherapeutic use 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 nontherapeutic use in 
the food-producing animal of the critical anti-
microbial animal 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 critical anti-
microbial animal drug conducted by the Sec-
retary and any other relevant information, 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.’’. 
TITLE 
II—USE 
OF 
CRITICAL 
ANTIMICROBIAL 
ANIMAL 
DRUGS IN AGRICULTURE 
SEC. 201. COLLECTION OF DATA ON CRITICAL ANTI-
MICROBIAL ANIMAL DRUGS. 
(a) IN GENERAL.—Chapter V of the Federal Food, 
Drug, and Cosmetic Act is amended by inserting after sec-
tion 512 (21 U.S.C. 360b) the following:
‘‘SEC. 512A. COLLECTION OF DATA ON CRITICAL ANTI-
MICROBIAL ANIMAL DRUGS. 
‘‘(a) IN GENERAL.—Not later than July 1 of each 
year, a manufacturer of a critical antimicrobial animal 
drug or an animal feed for food-producing animals bearing 
or containing a critical antimicrobial animal drug shall 
submit to the Secretary a report, in such form as the Sec-
retary shall require, containing information on the sales 
during the previous calendar year of the critical anti-
microbial animal drug or the animal feed. 
‘‘(b) INFORMATION
TO BE INCLUDED.—A report 
under subsection (a) shall— 
‘‘(1) state separately the quantity of the critical 
antimicrobial animal drug, including such quantity 
in animal feed bearing or containing the critical 
antimicrobial drug, sold for each kind of food-pro-
ducing animal; 
‘‘(2) describe the claimed purpose of use for the 
drug for each kind of food-producing animal as 
being for growth promotion, weight gain, feed effi-
ciency, disease prevention, disease control, disease 
treatment, or another purpose; and 
‘‘(3) describe the dosage form of the drug. 
‘‘(c) PUBLICATION.—
‘‘(1) IN GENERAL.—The Secretary shall make 
the information submitted under subsection (a) 
available to the public not less than annually. 
‘‘(2) PROTECTION OF CONFIDENTIALITY.—The 
Secretary may aggregate information, if necessary, 
so as to avoid disclosure under paragraph (1) of con-
fidential business information.’’. 
(b) VIOLATION.—Subsection (e) of section 301 of the 
Federal Food, Drug and Cosmetic Act (21 U.S.C. 331(e)) 
is amended by striking ‘‘515(f)’’ and inserting ‘‘512A, 
515(f)’’. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall take effect on January 1, 2006. 
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