[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1150 Introduced in House (IH)]
113th CONGRESS
1st Session
H. R. 1150
To amend the Federal Food, Drug, and Cosmetic Act to preserve the
effectiveness of medically important antimicrobials used in the
treatment of human and animal diseases.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
March 14, 2013
Ms. Slaughter introduced 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 preserve the
effectiveness of medically important antimicrobials used in the
treatment of human and animal diseases.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Preservation of Antibiotics for
Medical Treatment Act of 2013''.
SEC. 2. FINDINGS.
The Congress finds the following:
(1)(A) In 1977, the Food and Drug Administration concluded
that feeding livestock low doses of antibiotics used in human
disease treatment could promote the development of antibiotic-
resistance in bacteria. However, the Food and Drug
Administration did not act in response to these findings,
despite laws requiring the agency to do so.
(B) In 2012, the Food and Drug Administration was ordered
by a Federal court to address the use of antibiotics in
livestock, as the result of a lawsuit filed against the agency
citing the agency's failure to act in response to the 1977
findings.
(2)(A) 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.
(B) In 2009, Cook County Hospital and the Alliance for
Prudent Use of Antibiotics estimated that the total health care
cost of antibiotic resistant infections in the United States
was between $16,600,000,000 and $26,000,000,000 annually.
(3) An April 1999 study by the Government Accountability
Office concluded that resistant strains of 3 microorganisms
that cause food-borne illness or disease in humans (Salmonella,
Campylobacter, and E. coli) are linked to the use of
antibiotics in animals.
(4)(A) Large-scale, voluntary surveys by the Department of
Agriculture's Animal and Plant Health Inspection Service in
1999, 2001, and 2006 revealed that--
(i) 84 percent of grower-finisher swine farms, 83
percent of cattle feedlots, and 84 percent of sheep
farms administer antimicrobials in the feed or water
for health or growth promotion reasons; and
(ii) many of the antimicrobials identified are
identical or closely related to drugs used in human
medicine, including tetracyclines, macrolides,
Bacitracin, penicillins, and sulfonamides; and
(B) these drugs are used in people to treat serious
diseases such as pneumonia, scarlet fever, rheumatic fever,
sexually transmitted infections, skin infections, and even
pandemics like malaria and plague, as well as bioterrorism
agents like smallpox and anthrax.
(5)(A) Any overuse or misuse of antibiotics contributes to
the spread of antibiotic resistance, whether in human medicine
or in agriculture.
(B) Recognizing the public health threat caused by
antibiotic resistance, Congress took several steps to curb
antibiotic overuse in human medicine through amendments to the
Public Health Service Act (42 U.S.C. 201 et seq.) made by
section 102 of the Public Health Threats and Emergencies Act
(Public Law 106-505, title I; 114 Stat. 2315), but has not yet
addressed antibiotic overuse in agriculture.
(6) In January 2001, a Federal interagency task force--
(A) released an action plan to address the
continuing decline in effectiveness of antibiotics
against common bacterial infections, referred to as
antibiotic resistance;
(B) determined that antibiotic resistance is a
growing menace to all people and poses a serious threat
to public health; and
(C) cautioned that if current trends continue,
treatments for common infections will become
increasingly limited and expensive, and, in some cases,
nonexistent.
(7) The United States Geological Survey reported in March
2002 that--
(A) antibiotics were present in 48 percent of the
streams tested nationwide; and
(B) almost half of the tested streams were
downstream from agricultural operations.
(8) The peer-reviewed journal ``Clinical Infectious
Diseases'' published a report in June 2002 that--
(A) was based on a 2-year review by experts in
human and veterinary medicine, public health,
microbiology, biostatistics, and risk analysis, of more
than 500 scientific studies on the human health impacts
of antimicrobial use in agriculture; and
(B) recommended that antimicrobial agents should no
longer be used in agriculture in the absence of
disease, but should be limited to therapy for diseased
individual animals and prophylaxis when disease is
documented in a herd or flock.
(9) In a March 2003 report, the National Academy of
Sciences stated that--
(A) a decrease in antimicrobial use in human
medicine alone will have little effect on the current
situation; and
(B) substantial efforts must be made to decrease
inappropriate overuse in animals and agriculture.
(10) 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 safety.
(11)(A) In 2003, the Food and Drug Administration modified
the drug approval process for antibiotics to recognize the
development of resistant bacteria as an important aspect of
safety, but most antibiotics currently used in animal
production systems for nontherapeutic purposes were approved
before the Food and Drug Administration began considering
resistance during the drug-approval process.
(B) The Food and Drug Administration has not established a
schedule for reviewing those existing approvals.
(12)(A) In an April 2004 report, the Government
Accountability Office--
(i) concluded that Federal agencies do not collect
the critical data on antibiotic use in animals that
they need to support research on human health risks;
and
(ii) recommended that the Department of Agriculture
and the Department of Health and Human Services develop
and implement a plan to collect data on antibiotic use
in animals.
(B) In a September 2011 update to that report, the
Government Accountability Office--
(i) concluded that Federal agencies had made
limited progress in addressing antibiotic use in
animals;
(ii) recommended that Federal agencies fund
research on alternatives to current antibiotic use
practices; and
(iii) recommended that Federal agencies track the
effectiveness of policies that curb antibiotic
resistance, including FDA's voluntary guidelines
reducing antibiotic use in food animals.
(13) In 2009, the Congressional Research Service 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.
(14) In 2010, the peer-reviewed journal ``Molecular Cell''
published a study demonstrating that low-dosage use of
antibiotics causes a dramatic increase in genetic mutation,
raising new concerns about the agricultural practice of using
low-dosage antibiotics in order to stimulate growth promotion
and routinely prevent disease in unhealthy conditions.
(15) In 2010, the Danish Veterinary and Food Administration
testified that the Danish ban of the nontherapeutic use of
antibiotics in food animal production resulted in a marked
reduction in antimicrobial resistance in multiple bacterial
species, including Campylobacter and Enterococci.
(16) In 2011, the Food and Drug Administration determined
that--
(A) 13.5 million kilograms of antibacterial drugs
were sold for use on food animals in the United States
in 2010;
(B) 3.3 million kilograms of antibacterial drugs
were used for human health in 2010; and
(C) therefore, 80 percent of antibacterial drugs
disseminated in the United States in 2010 were sold for
use on food animals, rather than being used for human
health.
(17) In 2011, a review of all scientific studies on
antimicrobial use in farm animals, published in Clinical
Microbiology Reviews, found that--
(A) use of antibiotics in food animals leads to
development of reservoirs of antibiotic resistance;
(B) a ban on antibiotic use in food animals would
preserve their use for medicine; and
(C) a Danish ban on antibiotics in food animals
resulted in little change in animal morbidity and
mortality, and only a modest increase in production
cost.
(18) In April 2012, the Food and Drug Administration issued
voluntary guidance to industry on reducing antibiotic use in
livestock and poultry. As part of that guidance, it summarized
over 35 years of peer-reviewed scientific literature regarding
use of antimicrobial drugs in livestock. As a result, FDA
stated strategies for controlling antibiotic resistance are
needed, and are seeking voluntarily limits on antibiotic use.
(19)(A) In January 2013, Consumer Reports published test
results on pork products bought in grocery stores nationwide
showing disturbingly high levels of Salmonella and Yersinia
enterocolitica bacteria that were resistant to the antibiotics
used to treat food borne illnesses. A 2003 Consumer Report
study showed similar results in poultry products.
(B) The Food and Drug Administration's National
Antimicrobial Resistance Monitoring System routinely finds that
retail meat products are contaminated with bacteria (including
the foodborne pathogens Campylobacter and Salmonella) that are
resistant to antibiotics important in human medicine. The 2011
National Antimicrobial Resistance Monitoring System report
found that the percentage of meat containing antibiotic
resistant bacteria increases each year and that many of these
bacteria exhibit multiple antibiotic resistance.
(20) Antibiotic resistance, resulting in a reduced number
of effective antibiotics, may significantly impair the ability
of the United States to respond to terrorist attacks involving
bacterial infections or a large influx of hospitalized
patients.
(21) Many scientific studies confirm that the
nontherapeutic use of antibiotics in agricultural animals
contribute to the development of antibiotic-resistant bacterial
infections in people.
(22) Epidemiological research has shown that resistant
Salmonella and Campylobacter infections are associated with
increased numbers of ill patients and bloodstream infections,
and increased death.
(23) The American Medical Association, the American Public
Health Association, the National Association of County and City
Health Officials, and the National Sustainable Agriculture
Coalition are among the over 400 organizations representing
health, consumer, agricultural, environmental, humane, and
other interests that have supported enactment of legislation to
phase out nontherapeutic use in farm animals of medically
important antimicrobials.
SEC. 3. PURPOSE.
The purpose of this Act is to preserve the effectiveness of
medically important antimicrobials used in the treatment of human and
animal diseases.
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 amended--
(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 antimicrobial 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 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 animal of a drug--
``(A) that is a medically important antimicrobial;
or
``(B)(i) for which there is in effect an approval
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 withdraw 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 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 determination 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 nontherapeutic
use of the drug; or
``(B) before the date specified in subparagraph
(A), the Secretary makes a final written determination
under this subsection, with respect to a risk analysis
of the drug conducted by the Secretary and other
relevant information, 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-
producing animal of the medically important antimicrobial, as
of the date that is 2 years after the date on which the
Secretary grants the exemption.
``(4) Approvals.--Except as provided in paragraph (5), if
an application for a drug that is a 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
important 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 approved 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 important
antimicrobial; or
``(B) before the date specified in subparagraph
(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 information, 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 medically important antimicrobial.
``(6) Definition.--In this subsection:
``(A) The term `medically important antimicrobial'
means a drug that--
``(i) is intended for use in food-producing
animals; and
``(ii) is composed wholly or partly of--
``(I) any kind of penicillin,
tetracycline, macrolide, lincosamide,
streptogramin, aminoglycoside,
sulfonamide, or cephalosporin; or
``(II) a drug from an antimicrobial
class that is listed as `highly
important', `critically important', or
`important' by the World Health
Organization in the latest edition of
its publication entitled `Critically
Important Antimicrobials for Human
Medicine' (or a successor publication).
``(B) The term `therapeutic use', with respect to a
medically important antimicrobial, means the use of
antimicrobials for the specific purpose of treating an
animal with a documented disease or infection. Such
term does not include the continued use of such an
antimicrobial in the animal after the disease or
infection is resolved.
``(C) The term `nontherapeutic use'--
``(i) means administration of antibiotics
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 control.
``(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 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, noncustomary 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 amended 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 following:
``SEC. 512A. LIMITATIONS ON USE OF MEDICALLY IMPORTANT ANTIMICROBIALS
FOR NONROUTINE DISEASE CONTROL.
``(a) Prohibition.--It shall be unlawful to administer (including
by means of animal feed) a medically important antimicrobial to a food-
producing animal for nonroutine 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 important
antimicrobial to the food-producing animal is necessary to
prevent or reduce the risk of transmission of the disease or
infection described in paragraph (1);
``(3) the medically important antimicrobial is administered
to the food-producing animal for nonroutine disease control for
the shortest duration possible 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 prevent or
reduce the risk of transmission of the disease or
infection described in paragraph (1).
``(b) Definitions.--In this section:
``(1) The term `food-producing animal' means a food-
producing animal intended for sale in interstate commerce.
``(2) The terms `medically important antimicrobial' 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.
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