In this task, you are given text for US Congressional and California state bills, your task is to generate a summary for this bill.
Q: SECTION 1. SHORT TITLE.

This Act may be cited as the ''Preservation of Antibiotics for
Medical Treatment Act of 2011''.

SEC. 2. FINDINGS.

The Congress finds the following:
(1) 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.
(2) 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.
(3)(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.
(4) 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.
(5) In 2010, the FDA determined that--
(A) 13.1 million kilograms of antibacterial drugs
were sold for use on food animals in the United States
in 2009;
(B) 3.3 million kilograms of antibacterial drugs
were used for human health in 2009; and
(C) therefore, 80 percent of antibacterial drugs
disseminated in the United States in 2009 were sold for
use on food animals, rather than being used for human
health.
(6)(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,
venereal disease, skin infections, and even pandemics like
malaria and plague, as well as bioterrorism agents like
smallpox and anthrax.
(7) Many scientific studies confirm that the nontherapeutic
use of antibiotics in agricultural animals contributes to the
development of antibiotic-resistant bacterial infections in
people.
(8) The periodical entitled ''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) 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.
(10) An April 1999 study by the General Accounting 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.
(11) Epidemiological research has shown that resistant
Salmonella and Campylobacter infections are associated with
increased numbers of ill patients and bloodstream infections,
and increased death.
(12) 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.
(13)(A) In January 2003, Consumer Reports published test
results on poultry products bought in grocery stores nationwide
showing disturbingly high levels of Campylobacter and
Salmonella bacteria that were resistant to the antibiotics used
to treat food-borne illnesses.
(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.
(C) In December 2007, the USDA issued a fact sheet on the
recently recognized link between antimicrobial drug use in
animals and Methicillin Resistant Staphylococcus Aureas (MRSA)
infections in humans.
(14) In October 2001, the New England Journal of Medicine
published an editorial urging a ban on nontherapeutic use of
medically important antibiotics in animals.
(15)(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.
(16) The American Medical Association, the American Public
Health Association, the National Association of County and City
Health Officials, and the National Campaign for Sustainable
Agriculture are among the more than 300 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 antibiotics.
(17) In 2010, the Danish Veterinary and Food Administration
testified that the Danish ban of the non-therapeutic use of
antibiotics in food animal production resulted in a marked
reduction in antimicrobial resistance in multiple bacterial
species, including Campylobacter and Enterococci.
(18) In 2009, the Congressional Research Service concluded
that restrictions overseas on the use of antimicrobial drugs in
the production of livestock could impact U.S. export markets
for livestock and poultry.
(19) 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.
(20)(A) The Food and Drug Administration recently 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.
(21) Certain non-routine uses of antibiotics in animal
agriculture are legitimate to prevent animal disease.
(22) An April 2004 study by the General Accounting Office--
(A) 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
(B) recommends 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.

SEC. 3. PURPOSE.

The purpose of this Act is to preserve the effectiveness of
medically important antibiotics used in the treatment of human and
animal diseases by reviewing the safety of certain antibiotics for
nontherapeutic purposes in food-producing animals.

SEC. 4. PROOF OF SAFETY OF CRITICAL ANTIMICROBIAL ANIMAL DRUGS.

(a) Definitions.--Section 201 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the
following:
''(ss) Critical Antimicrobial Animal Drug.--The term 'critical
antimicrobial animal drug' means a drug that--
''(1) is intended for use in food-producing animals; and
''(2) is composed wholly or partly of--
''(A) any kind of penicillin, tetracycline,
macrolide, lincosamide, streptogramin, aminoglycoside,
or sulfonamide; or
''(B) any other drug or derivative of a drug that
is used in humans or intended for use in humans to
treat or prevent disease or infection caused by
microorganisms.
''(tt) Nontherapeutic Use.--The term 'nontherapeutic use', with
respect to a critical antimicrobial animal drug, means any use of the
drug as a feed or water additive for an animal in the absence of any
clinical sign of disease in the animal for growth promotion, feed
efficiency, weight gain, routine disease prevention, or other routine
purpose.''.
(b) 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 critical antimicrobial
animal drug or a drug of the same chemical class as a
critical antimicrobial animal drug, 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 of the drug; or''; and
(2) in the second sentence, by striking ''(A) through (I)''
and inserting ''(A) through (J)''.
(c) Phased Elimination of Nontherapeutic Use in Animals of Critical
Antimicrobial Animal Drugs Important for Human Health.--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
Critical Antimicrobial Animal Drugs Important for Human Health.--
''(1) Applicability.--This subsection applies to the
nontherapeutic use in a food-producing animal of a drug--
''(A)(i) that is a critical antimicrobial animal
drug; or
''(ii) that is of the same chemical class as a
critical antimicrobial animal drug; and
''(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 use.
''(2) Withdrawal.--The Secretary shall withdraw the
approval of a nontherapeutic use in food-producing animals
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 critical antimicrobial animal drug, the
Secretary shall rescind each approval of a nontherapeutic use
in a food-producing animal of the critical antimicrobial animal
drug, or of a drug in the same chemical class as the critical
antimicrobial animal drug, 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 critical antimicrobial
animal drug 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 critical antimicrobial
animal drug, or of a drug in the same chemical class as the
critical antimicrobial animal drug, as of the date that is 2
years after the date on which the application is submitted to
the Secretary.
''(5) Exception.--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 critical antimicrobial animal
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 critical antimicrobial animal drug 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 drug.''.

SEC. 5. COMMITTEE HEARINGS ON IMPLEMENTATION.

(a) In General.--The Committee on Energy and Commerce of the House
of Representatives and the Committee on Energy of the Senate shall each
hold a hearing on the implementation by the Commissioner of Food and
Drugs of section 512(q) of the Federal Food, Drug, and Cosmetic Act, as
added by section 4 of this Act.
(b) Exercise of Rulemaking Authority.--Subsection (a) is enacted--
(1) as an exercise of the rulemaking power of the House of
Representatives and Senate, and, as such, they shall be
considered as part of the rules of the House or Senate (as the
case may be), and such rules shall supersede any other rule of
the House or Senate only to the extent that rule is
inconsistent therewith; and
(2) with full recognition of the constitutional right of
either House to change such rules (so far as relating to the
procedure in such House) at any time, in the same manner, and
to the same extent as in the case of any other rule of the
House or Senate.
A:
Preservation of Antibiotics for Medical Treatment Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to deny an application for a new animal drug that is a critical antimicrobial animal drug unless the applicant demonstrates that there is a reasonably certainty of no harm to human health due to the development of antimicrobial resistance attributable to the nontherapeutic use of the drug. Defines "critical antimicrobial animal drug" as a drug intended for use in food-producing animals that contains specified antibiotics or other drugs used in humans to treat or prevent disease or infection caused by microorganisms.

Requires the Secretary to withdraw approval of a nontherapeutic use of such drugs in food-producing animals two years after the date of enactment of this Act unless certain safety requirements are met. Directs specified congressional committees to hold hearings on the implementation of such a withdrawal of approval.