I
106TH CONGRESS
1ST SESSION
H. R. 3266
To direct that essential antibiotic drugs not be used in livestock unless
there is a reasonable certainty of no harm to human health.
IN THE HOUSE OF REPRESENTATIVES
NOVEMBER 9, 1999
Mr. BROWN of Ohio (for himself, Mr. WAXMAN, and Ms. SLAUGHTER) intro-
duced the following bill; which was referred to the Committee on Com-
merce
A BILL
To direct that essential antibiotic drugs not be used in live-
stock unless there is a reasonable certainty of no harm
to human health.
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 Essen-
tial Antibiotics for Human Diseases Act of 1999’’.
SEC. 2. FINDINGS AND PURPOSE.
(a) FINDINGS.—The Congress finds the following:
(1) Several antibiotics, particularly penicillin,
tetracycline, erythromycin, lincomycin, tylosin, baci-
tracin and virginiamycin, that either are used in or
are related to antibiotics used in humans to treat in-
fectious diseases are also used in animal feed in sub-
therapeutic amounts in order to promote the ani-
mals’ growth.
(2) Mounting scientific evidence shows that
using those antibiotics in livestock feed can lead to
antibiotic-resistant bacteria that can be transferred
to people, making it harder to treat certain infec-
tions.
(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. All developed countries in the world, with
the exception of the United States and Canada, cur-
rently follow such recommendations.
(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 4 re-
maining human-use antibiotics still in use at sub-
therapeutic levels to promote animal growth. The
ban on using virginiamycin, tylosin, spiramycin, and
bacitracin in animal feed became effective for the 15
member states of the European Union on July 1,
1999. Prior to that action, individual 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 states that resistant strains of 3 spe-
cific organisms that cause illness or disease in hu-
mans—salmonella, campylobacter, and E. coli—are
linked to the use of antibiotics in animals.
(8) Removing certain antibiotics from subthera-
peutic use will not hinder the raising of livestock be-
cause non-antimicrobial growth promoters, alter-
native antibiotics, and alternative husbandry prac-
tices are available.
(b) PURPOSE.—The purpose of this Act is to insure
that certain antimicrobial drugs essential to human health
are not used subtherapeutically in food animals unless
there is a reasonable certainty of no harm to human health
due to the development of antimicrobial resistance as a
result of such use.
SEC. 3. REQUIRING PROOF OF SAFETY.
(a) IN GENERAL.—Section 512(d)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360b(d)(1)) is
amended by striking ‘‘or’’ at the end of subparagraph (H),
by redesignating subparagraph (I) as subparagraph (J),
and by adding after subparagraph (H) the following:
‘‘(I) the Secretary is unable to determine, based
on data submitted by the applicant, that there is a
reasonable certainty of no harm to human health
due to the development of antimicrobial resistance
which is attributable to the subtherapeutic use of
such drug; or’’.
(b) WITHDRAWAL OF APPROVAL.—Section 512(e) of
such Act (21 U.S.C. 360b(e)) is amended by redesignating
paragraph (3) as paragraph (4) and by inserting after
paragraph (2) the following:
‘‘(3)(A) Except as provided in subparagraph (B), 2
years after the date of the enactment of this paragraph,
approval pursuant to subsection (b) with respect to the
subtherapeutic use of penicillin, tetracycline, erythro-
mycin, lincomycin, tylosin, bacitracin, virginiamycin, or
other antimicrobial new animal drugs in animals is
deemed to be withdrawn and the use will be deemed unsafe
for the purposes of section 501(a)(6) unless, based on data
submitted by the applicant, the Secretary determines that
there is a reasonable certainty of no harm to human health
due to the development of antimicrobial resistance which
is attributable to the subtherapeutic use of such drug.
‘‘(B) If the Secretary determines that there is not
a reasonable certainty of no harm to human health due
to the development of antibiotic resistance that is attrib-
utable to the subtherapeutic use of such drug, the Sec-
retary may issue an order withdrawing approval sooner
than 2 years after the date of enactment of this para-
graph.’’.
(c) DEFINITION.—Section 512 of such Act is amend-
ed by adding at the end the following:
‘‘(q) For purposes of this section, the term ‘subthera-
peutic use’ means any use of an antimicrobial drug in ani-
mals other than the high level, short term use to treat
ill animals.’’.
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