(15) There is inadequate distinction between 
usage for disease prevention and production pur-
poses, such as growth promotion, on FDA approved 
drug labels. A 2014 analysis of the approved animal 
drugs affected by Guidance 213 by the Pew Chari-
table Trusts found that numerous approved drug la-
bels contained overlapping indications for growth- 
promotion and disease prevention. 
(16) The European Union (EU) banned the use 
of antibiotics for growth promotion in 2006, a full 
decade before the FDA’s voluntary approach will go 
into effect. 
(17) Since the EU ban, antibiotic usage has de-
creased without affecting livestock production. 
(18) In 2010, the Danish Veterinary and Food 
Administration testified that the Danish ban of the 
nontherapeutic use of antibiotics in food-animal pro-
duction resulted in a marked reduction in anti-
microbial resistance in multiple bacterial species, in-
cluding Campylobacter and Enterococci. 
(19) The experience in the Netherlands has 
shown that during the phaseout use indications for 
growth promotion were completely supplanted by 
disease prevention. Total antibiotic consumption re-
mained constant. After the implementation of man-
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datory reduction targets and improved surveillance 
of usage practices antibiotic consumption declined 
ahead of target without impacting production levels. 
(20) In 2009, the Congressional Research Serv-
ice concluded that without restrictions on the use of 
antimicrobial drugs in the production of livestock, 
export markets for livestock and poultry could be 
negatively impacted due to restrictions on the use of 
antibiotics in other nations. 
(21) The American Medical Association, the In-
fectious Disease Society of America, the American 
Public Health Association, the National Association 
of County and City Health Officials, and the Na-
tional Sustainable Agriculture Coalition are among 
the over 400 organizations representing health, con-
sumer, agricultural, environmental, humane, and 
other interests that have supported enactment of 
legislation to phaseout nontherapeutic use in farm 
animals of medically important antimicrobials. 
SEC. 3. PURPOSE. 
The purpose of this Act is to preserve the effective-
ness of medically important antimicrobials used in the 
treatment of human and animal diseases. 
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SEC. 4. PROOF OF SAFETY OF MEDICALLY IMPORTANT 
ANTIMICROBIALS. 
(a) 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 medically important 
antimicrobial (as defined in subsection (q)), the 
applicant has failed to demonstrate 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 (as defined in 
subsection (q)) of the medically important anti-
microbial or drug;’’; and 
(2) in the second sentence, by striking ‘‘(A) 
through (I)’’ and inserting ‘‘(A) through (J)’’. 
(b) PHASED ELIMINATION
OF NONTHERAPEUTIC 
USE
IN
ANIMALS
OF
MEDICALLY
IMPORTANT 
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ANTIMICROBIALS.—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
MEDICALLY
IMPORTANT 
ANTIMICROBIALS.— 
‘‘(1) APPLICABILITY.—This paragraph applies 
to the nontherapeutic use in a food-producing ani-
mal of a drug— 
‘‘(A) that is a medically important anti-
microbial; or 
‘‘(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 human 
use. 
‘‘(2) WITHDRAWAL.—The Secretary shall with-
draw the approval of a nontherapeutic use in food- 
producing animals of a drug described in paragraph 
(1) on the date that is 2 years after the date of en-
actment 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 medically 
important antimicrobial, the Secretary shall rescind 
each approval of a nontherapeutic use in a food-pro-
ducing animal of the medically important anti-
microbial as of the date that is 2 years after the 
date on which the Secretary grants the exemption. 
‘‘(4) APPROVALS.—Except as provided in para-
graph (5), if an application for a drug that is a 
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medically important antimicrobial 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 medically impor-
tant antimicrobial as of the date that is 2 years 
after the date on which the application is submitted 
to the Secretary. 
‘‘(5) EXCEPTIONS.—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 medically im-
portant antimicrobial; or 
‘‘(B) before the date specified in subpara-
graph (A), the Secretary makes a final written 
determination, with respect to a risk analysis of 
the medically important antimicrobial conducted 
by the Secretary and any other relevant infor-
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mation, that there is a reasonable certainty of 
no harm to human health due to the develop-
ment of antimicrobial resistance that is attrib-
utable in whole or in part to the nontherapeutic 
use of the medically important antimicrobial. 
‘‘(6) DEFINITION.—In this subsection: 
‘‘(A) The term ‘medically important anti-
microbial’ means a drug that— 
‘‘(i) is intended for use in food-pro-
ducing animals; and 
‘‘(ii) is composed wholly or partly of— 
‘‘(I) any kind of penicillin, tetra-
cycline, macrolide, lincosamide, strep-
togramin, 
aminoglycoside, 
sulfon-
amide, or cephalosporin; or 
‘‘(II) a drug from an anti-
microbial class that is listed as ‘highly 
important’, ‘critically important’, or 
‘important’ by the World Health Or-
ganization in the latest edition of its 
publication entitled ‘Critically Impor-
tant Antimicrobials for Human Medi-
cine’ (or a successor publication). 
‘‘(B) The term ‘therapeutic use’, with re-
spect to a medically important antimicrobial, 
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means the use of antimicrobials for the specific 
purpose of treating an animal with a docu-
mented disease or infection. Such term does not 
include the continued use of such an anti-
microbial in the animal after the disease or in-
fection is resolved. 
‘‘(C) The term ‘nontherapeutic use’— 
‘‘(i) means administration of anti-
biotics to an animal through feed and 
water (or, in poultry hatcheries, through 
any means) for purposes (such as growth 
promotion, feed efficiency, weight gain, or 
disease prevention) other than therapeutic 
use or nonroutine disease control; and 
‘‘(ii) includes any repeated or regular 
pattern of use of medically important 
antimicrobials for purposes other than 
therapeutic use or nonroutine disease con-
trol. 
‘‘(D) The term ‘noncustomary situation’ 
does not include normal or standard practice 
and conditions on the premises that facilitate 
the transmission of disease. 
‘‘(E) The term ‘nonroutine disease control’ 
means the use of antibiotics on an animal that 
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is not sick but where it can be shown that a 
particular disease or infection is present, or is 
likely to occur because of a specific, noncus-
tomary situation, on the premises at the barn, 
house, pen, or other level at which the animal 
is kept.’’. 
SEC. 5. LIMITATIONS ON USE OF MEDICALLY IMPORTANT 
ANTIMICROBIALS FOR NONROUTINE DISEASE 
CONTROL. 
(a) PROHIBITED ACTS.—Section 301 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend-
ed by adding at the end the following: 
‘‘(ccc) The administration of a medically important 
antimicrobial to a food-producing animal for nonroutine 
disease control in violation of the requirements of section 
512A.’’. 
(b) REQUIREMENTS.—Chapter V of the Federal 
Food, Drug, and Cosmetic Act is amended by inserting 
after section 512 of such Act (21 U.S.C. 360b) the fol-
lowing: 
‘‘SEC. 512A. LIMITATIONS ON USE OF MEDICALLY IMPOR-
TANT ANTIMICROBIALS FOR NONROUTINE 
DISEASE CONTROL. 
‘‘(a) PROHIBITION.—It shall be unlawful to admin-
ister (including by means of animal feed) a medically im-
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portant antimicrobial to a food-producing animal for non-
routine disease control unless— 
‘‘(1) there is a significant risk that a disease or 
infection present on the premises will be transmitted 
to the food-producing animal; 
‘‘(2) the administration of the medically impor-
tant antimicrobial to the food-producing animal is 
necessary to prevent or reduce the risk of trans-
mission of the disease or infection described in para-
graph (1); 
‘‘(3) the medically important antimicrobial is 
administered to the food-producing animal for non-
routine disease control for the shortest duration pos-
sible to prevent or reduce the risk of transmission of 
the disease or infection described in paragraph (1) 
to the animal; and 
‘‘(4) the medically important antimicrobial is 
administered— 
‘‘(A) at a scale no greater than the barn, 
house, or pen level; and 
‘‘(B) to the fewest animals possible to pre-
vent or reduce the risk of transmission of the 
disease or infection described in paragraph (1). 
‘‘(b) DEFINITIONS.—In this section: 
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‘‘(1) The term ‘food-producing animal’ means a 
food-producing animal intended for sale in interstate 
commerce. 
‘‘(2) The terms ‘medically important anti-
microbial’ and ‘nonroutine disease control’ have the 
meanings given to such terms in section 512(q).’’. 
(c) APPLICABILITY.—The amendments made by this 
section apply beginning on the date that is 6 months after 
the date of the enactment of this Act. 
Æ 
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