113 S1256 IS: Preventing Antibiotic Resistance Act of 2013
U.S. Senate
2013-06-27
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
1.This Act may be cited as the
Preventing Antibiotic Resistance Act
of 2013
.
2.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 foodborne 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.
(B)Such 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 such as 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; 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
the Food and Drug Administration’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)13,500,000
kilograms of antibacterial drugs were sold for use on food animals in the
United States in 2010;
(B)3,300,000
kilograms of antibacterial drugs were used for human health in 2010; and
(C)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
nontherapeutic antibiotic use in food animals would preserve the use of such
antibiotics for medicine; and
(C)a Danish ban on
nontherapeutic 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, the Food and Drug
Administration 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
foodborne 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 more than 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.
3.The purpose of this Act is to preserve the
effectiveness of medically important antimicrobials used in the treatment of
human and animal diseases.
4.Proof of safety
of medically important antimicrobials
(a)Applications
pending or submitted after enactmentSection 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
antimicrobialsSection 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)This
subsection applies to the nontherapeutic use in a food-producing animal of a
drug—
(A)that is a
medically important antimicrobial;
(B)for which there is
in effect an approval of an application or an exemption under subsection (b),
(i), or (j) of section 505; or
(C)that is otherwise
marketed for human use.
(2)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)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, effective on
the date that is 2 years after the date on which the Secretary grants the
exemption.
(4)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, effective on
the date that is 2 years after the date on which the application is submitted
to the Secretary.
(5)Paragraph
(3) or (4), as applicable, 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)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 or 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 in the feed or water of an animal
that is not sick, where it can be shown that a particular disease or infection
is, or is likely to be, present on the premises because of a specific,
non-customary
situation.
.
5.Limitations on
use of medically important antimicrobials for nonroutine disease
control
(a)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)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:
512A.Limitations on
use of medically important antimicrobials for nonroutine disease
control
(a)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)(A)there is a significant
risk that a disease or infection present on, or likely present on, the premises
will be transmitted to the food-producing animal;
(B)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);
(C)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
(D)the medically important antimicrobial
is administered—
(i)at a scale no greater than the
barn, house, or pen level; and
(ii)to the fewest animals possible to
prevent or reduce the risk of transmission of the disease or infection
described in paragraph (1); or
(2)the Secretary
determines 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 such use of the medically important antimicrobial and such use does
not threaten the public health.
(b)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 such terms in section
512(q).
.
(c)The
amendments made by this section apply beginning on the date that is 2 years
after the date of the enactment of this Act.
6.Sense of the
Senate regarding veterinary oversight of use of medically important
antimicrobials
(a)It is the sense of the Senate that a valid
veterinarian-client-patient relationship should exist to ensure that medically
important antimicrobials are used in a manner that is consistent with
professionally accepted best practices.
(b)Veterinarian-Client-Patient
relationshipIn ths section, the term
veterinarian-client-patient relationship means a relationship in
which all of the following criteria are met:
(1)The veterinarian
has assumed the responsibility for making medical judgments regarding the
health of the patient and the client has agreed to follow the veterinarian's
instructions.
(2)The veterinarian
has sufficient knowledge of the patient to initiate at least a general or
preliminary diagnosis of the medical condition of the patient. This means that
the veterinarian is personally acquainted with the keeping and care of the
patient by virtue of—
(A)a timely
examination of the patient by the veterinarian; or
(B)medically
appropriate and timely visits by the veterinarian to the premises where the
animal or animals are kept.
(3)The veterinarian
is readily available for follow-up evaluation or has arranged for veterinary
emergency coverage and continuing care and treatment.
(4)The veterinarian
provides oversight of treatment, compliance, and outcome.
(5)Patient records are maintained.