I
107TH CONGRESS
2D SESSION
H. R. 3804
To amend the Federal Food, Drug, and Cosmetic Act to ensure that use
of certain antibiotic drugs in animal agriculture does not compromise
human health by contributing to the development of antibiotic resistance.
IN THE HOUSE OF REPRESENTATIVES
FEBRUARY 27, 2002
Mr. BROWN of Ohio (for himself, Mr. WAXMAN, and Ms. SLAUGHTER) intro-
duced the following bill; which was referred to the Committee on Energy
and Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to
ensure that use of certain antibiotic drugs in animal
agriculture does not compromise human health by con-
tributing to the development of antibiotic resistance.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Preservation of Anti-
biotics for Human Treatment Act of 2002’’.
SEC. 2. FINDINGS.
The Congress finds as follows:
(1) Several antibiotics and classes of antibiotics,
particularly penicillins, tetracyclines, macrolides (in-
cluding but not limited to erythromycin and tylosin),
lincomycin, 
bacitracin, 
virginiamycin, 
amino-
glycosides, and sulfonamides, that either are used in
or are related to antibiotics used in humans to treat
infectious diseases are also routinely administered to
healthy agricultural animals, generally via feed or
water, in order to promote the animals’ growth or to
prevent disease. Such uses do not require a veteri-
narian’s prescription.
(2) Mounting scientific evidence shows that this
nontherapeutic use of antibiotics in agricultural ani-
mals can lead to development of antibiotic-resistant
bacteria that can be transferred to people, making it
harder to treat certain infections.
(3) In 1969, the Swann Committee was formed
in the United Kingdom to examine the public health
effects of use of antimicrobial drugs in food-pro-
ducing animals. The Committee recommended that
antimicrobials be divided into ‘‘feed’’ and ‘‘thera-
peutic’’ classes of drugs and that the ‘‘feed’’ class
not include drugs used therapeutically in humans or
animals. Most developed countries in the world, with
the exception of the United States and Canada, re-
strict the use of antimicrobials in animal production
systems for growth promotion.
(4) In 1997, the World Health Organization
recommended that antibiotics used to treat humans
should not also be used to promote animal growth,
although such antibiotics could still be used to treat
ill animals.
(5) In July 1998, the National Academy of
Sciences, in a report prepared at the request of the
United States Department of Agriculture and the
Food and Drug Administration, concluded ‘‘there is
a link between the use of antibiotics in food animals,
the development of bacterial resistance to these
drugs, and human disease’’.
(6) In December 1998, health ministers for the
European Union countries voted to ban the remain-
ing human-use antibiotics still in use to promote ani-
mal growth. The ban on using virginiamycin, tylosin,
spiramycin, and bacitracin in animal feed became ef-
fective for the 15 member states of the European
Union on July 1, 1999. Prior to that action, indi-
vidual European countries, including the United
Kingdom, Denmark, Finland, and Sweden, had
banned the use in animal feed of specific antibiotics.
(7) An April 1999 study by the General Ac-
counting Office concluded that resistant strains of
three microorganisms that cause foodborne illness or
disease in humans—salmonella, campylobacter, and
E. coli—are linked to the use of antibiotics in ani-
mals.
(8) In October 2000, the Food and Drug Ad-
ministration issued a notice announcing its intention
to withdraw approvals for use of fluoroquinolone
antibiotics in poultry, in light of the fact that in-
creased resistance to fluoroquinolones in certain bac-
teria followed approval of those antibiotics for such
use in the mid-1990s. While one company (Abbott
Laboratories) immediately agreed to voluntarily
withdraw its product, the only other manufacturer
(Bayer Corp.) is contesting FDA’s proposed with-
drawal and continues to market its product. Pre-
vious proceedings by FDA to withdraw approval of
animal drugs have taken substantial amounts of
time following initiation of formal action by FDA,
including 6 years in one instance and 20 in another.
(9) In November 2000, the American Medical
Association, American Public Health Association,
and other health organizations urged Bayer Corp. to
comply voluntarily with FDA’s proposed ban.
(10) In June 2001, the American Medical Asso-
ciation adopted a resolution opposing nontherapeutic
use of antimicrobials in animal agriculture. Organi-
zations that have taken a similar position include
the American College of Preventive Medicine, the
American Public Health Association, and the Coun-
cil of State and Territorial Epidemiologists.
(11) In October 2001, the New England Jour-
nal of Medicine published a guest editorial titled
‘‘Antimicrobials in Animal Feed—Time to Stop’’.
The editorial urged a ban on nontherapeutic use in
animals of medically important antibiotics, and on
use in animals of fluoroquinolones.
(12) In January 2001, a Federal Interagency
Task Force released an Action Plan, which notes
that ‘‘drug-resistant pathogens are a growing men-
ace to all people, regardless of age, gender, or socio-
economic background. If we do not act to address
the problem . . . [d]rug choices for the treatment of
common infections will become increasingly limited
and expensive—and, in some cases, nonexistent.’’.
(13) Scientific studies have shown that resist-
ance traits can be transferred among unrelated spe-
cies of bacteria, including from nonpathogens to
pathogens.
SEC. 3. REQUIRING PROOF OF SAFETY OF ANTIMICROBIAL
NEW ANIMAL DRUGS.
(a) NONTHERAPEUTIC USE; APPLICATIONS PENDING
ON
OR
SUBMITTED
AFTER
ENACTMENT.—Section
512(d)(1) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(d)(1)) is amended—
(1) in subparagraph (H), by striking ‘‘or’’ at
the end;
(2) by redesignating subparagraph (I) as sub-
paragraph (J);
(3) by inserting after subparagraph (H) the fol-
lowing subparagraph:
‘‘(I) such drug is an antimicrobial new animal
drug and 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 such drug; or’’;
and
(4) in the matter after and below subparagraph
(J) (as redesignated by paragraph (2) of this sub-
section), by striking ‘‘(A) through (I)’’ and inserting
‘‘(A) through (J)’’.
(b) NONTHERAPEUTIC USE; RESCINDING
OF AP-
PROVAL FOR CERTAIN CURRENTLY APPROVED DRUGS.—
Section 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b) is amended by adding at the end the
following subsection:
‘‘(q) With respect to each antimicrobial new animal
drug for which, as of the day before the date of the enact-
ment of the Preservation of Antibiotics for Human Treat-
ment Act of 2002, there was in effect an approval of an
application filed pursuant to subsection (b), the approval
of a nontherapeutic use of such drug (including use
through animal feed that bears or contains such drug) is
subject to the following, as applicable:
‘‘(1) In the case of penicillins, tetracyclines,
macrolides (including but not limited to erythro-
mycin 
and 
tylosin), 
lincomycin, 
bacitracin,
virginiamycin, aminoglycosides, and sulfonamides:
‘‘(A) Each approval of a nontherapeutic
use of any of such drugs in an animal is re-
scinded upon the expiration of the two-year pe-
riod beginning on such date of enactment un-
less, before the expiration of such period, the
Secretary determines that the holder of the ap-
proved 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 nontherapeutic use of such drug.
‘‘(B) In carrying out subparagraph (A),
the Secretary may not consider any data re-
garding the antimicrobial new animal drug in-
volved that is submitted to the Secretary after
the expiration of the 180-day period beginning
on such date of enactment, unless such data
were not available for submission within such
180-day period.
‘‘(C) If pursuant to subparagraph (A) the
Secretary determines, with respect to the anti-
microbial new animal drug involved, that there
is not a reasonable certainty of no harm to
human health, the Secretary may issue an order
withdrawing approval of such drug at any time
before the date on which the drug would be re-
scinded under such subparagraph.
‘‘(2) In the case of an antimicrobial new animal
drug that is not referred to in paragraph (1):
‘‘(A) If the Secretary grants an exemption
under section 505(i) regarding such a drug, or
a drug with substantially the same active ingre-
dients, each approval of a nontherapeutic use of
such new animal drug in an animal is rescinded
upon the expiration of the two-year period be-
ginning on the date on which the Secretary pro-
vides notice in accordance with subparagraph
(C) regarding the new animal drug, except as
provided in subparagraph (D). Such notice shall
be so provided not later than 10 days after the
date on which the Secretary grants the exemp-
tion under section 505(i).
‘‘(B) If an application for such a drug, or
a drug with substantially the same active ingre-
dients, is submitted to the Secretary under sec-
tion 505(b) or under section 351 of the Public
Health Service Act, and the Secretary has not
previously granted an exemption under section
505(i) regarding the drug, each approval of a
nontherapeutic use of such new animal drug in
an animal is rescinded upon the expiration of
the two-year period beginning on the date on
which the Secretary provides notice in accord-
ance with subparagraph (C) regarding the new
animal drug, except as provided in subpara-
graph (D). Such notice shall be so provided not
later than 10 days after the date on which the
Secretary receives the application under section
505(b) or under such section 351, as the case
may be.
‘‘(C) For purposes of subparagraph (A)
and (B), notice regarding the antimicrobial new
animal drug involved is provided in accordance
with this subparagraph if the Secretary informs
the holder of the approved application for the
nontherapeutic use of such drug, in writing, of
the applicability of this paragraph to such ap-
plication (including that approval of the appli-
cation will be rescinded, except as provided in
subparagraph (D), and including the oppor-
tunity under subparagraph (E) to submit data).
‘‘(D) Subparagraph (A) or (B), as the case
may be, applies to the antimicrobial new animal
drug involved unless, before the date on which
approval would be rescinded under such sub-
paragraph, the Secretary determines that the
holder of the approved application has dem-
onstrated 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 nonthera-
peutic use of such drug.
‘‘(E) In carrying out subparagraph (A) or
(B), the Secretary may not consider any data
regarding the antimicrobial new animal drug in-
volved that is submitted to the Secretary after
the expiration of the 180-day period beginning
on the date on which the Secretary provides no-
tice in accordance with subparagraph (C) to the
holder of the approved application for the non-
therapeutic use of such drug.
‘‘(F) If pursuant to subparagraph (A) or
(B) the Secretary determines, with respect to
the antimicrobial new animal drug involved,
that there is not a reasonable certainty of no
harm to human health, the Secretary may issue
an order withdrawing approval of such drug at
any time before the date on which the drug
would be rescinded under such subparagraph.’’.
(c) ALL USES OF FLUOROQUINOLONES IN POULTRY;
RESCINDING OF APPROVAL FOR CURRENTLY APPROVED
DRUGS.—Section 512 of the Federal Food, Drug, and
Cosmetic Act, as amended by subsection (b) of this sec-
tion, is amended by adding at the end the following:
‘‘(r) With respect to a fluoroquinolone for which, as
of the day before the date of the enactment of the Preser-
vation of Antibiotics for Human Treatment Act of 2002,
there was in effect an approval of an application filed pur-
suant to subsection (b), the use of such drug (including
use through animal feed that bears or contains such drug)
is subject to the following:
‘‘(1) Each approval of the use of such drug in
poultry is rescinded upon the expiration of the 180-
day period beginning on such date of enactment un-
less, before the expiration of such period, the Sec-
retary determines that the holder of the approved
application has demonstrated that there is a reason-
able certainty of no harm to human health due to
the development of antimicrobial resistance that is
attributable, in whole or in part, to the use of such
drug in poultry.
‘‘(2) In carrying out paragraph (1), the Sec-
retary may not consider any data regarding a
fluoroquinolone that is submitted to the Secretary by
the holder of the approved application unless such
data has been submitted to FDA Docket No. 00N–
1571. The preceding sentence may not be construed
as requiring the Secretary to accept further submis-
sions to such docket if the period designated by the
Secretary for the receipt of such submissions has
ended.’’.
(d) DEFINITION OF NONTHERAPEUTIC USE.—Sec-
tion 512 of the Federal Food, Drug, and Cosmetic Act,
as amended by subsection (c) of this section, is amended
by adding at the end the following:
‘‘(s) For purposes of this section, the term ‘nonthera-
peutic use’, with respect to an antimicrobial new animal
drug, means any use of such drug in an animal in the
absence of disease, including use for growth promotion,
feed efficiency, or routine disease prevention.’’.
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