SEC. 4. 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: 
‘‘(ss) 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. 
‘‘(tt) 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.’’. 
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(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) in subparagraph (I), by inserting ‘‘or’’ 
at the end; and 
(C) by inserting after subparagraph (I) the 
following: 
‘‘(J) 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 
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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 
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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. 
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‘‘(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 
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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.’’. 
SEC. 5. COMMITTEE HEARINGS ON IMPLEMENTATION. 
(a) IN GENERAL.—The Committee on Energy and 
Commerce of the House of Representatives and the Com-
mittee on Energy of the Senate shall each hold a hearing 
on the implementation by the Commissioner of Food and 
Drugs of section 512(q) of the Federal Food, Drug, and 
Cosmetic Act, as added by section 4 of this Act. 
(b) EXERCISE OF RULEMAKING AUTHORITY.—Sub-
section (a) is enacted— 
(1) as an exercise of the rulemaking power of 
the House of Representatives and Senate, and, as 
such, they shall be considered as part of the rules 
of the House or Senate (as the case may be), and 
such rules shall supersede any other rule of the 
House or Senate only to the extent that rule is in-
consistent therewith; and 
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(2) with full recognition of the constitutional 
right of either House to change such rules (so far 
as relating to the procedure in such House) at any 
time, in the same manner, and to the same extent 
as in the case of any other rule of the House or Sen-
ate. 
Æ 
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