[Congressional Record Volume 157, Number 86 (Wednesday, June 15, 2011)]
[Senate]
[Pages S3837-S3841]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mrs. FEINSTEIN (for herself, Ms. Collins, Mr. Reed, and Mrs. 
        Boxer):
  S. 1211. A bill amend the Federal Food, Drug, and Cosmetic Act to 
preserve the effectiveness of medically important antibiotics used in 
the treatment of human and animal diseases; to the Committee on Health, 
Education, Labor, and Pensions.
  Mrs. FEINSTEIN. Mr. President, I rise today to introduce the 
Preservation of Antibiotics for Medical Treatment Act of 2011.
  Introducing this bill today is bittersweet. As my colleagues know, we 
have been working to pass this bill for almost a decade now. But for 
all those years it was one of our dearest colleagues, Senator Ted 
Kennedy, who stood before this body to introduce the legislation.
  We certainly miss Senator Kennedy's leadership, his passion, his 
dedication and his political skill.
  But as I stand here today to introduce the Preservation of 
Antibiotics for Medical Treatment Act, I know that he would be proud to 
see the continued work and support for this bill.
  Today, I am joined by Senator Collins, Senator Reed of Rhode Island 
and Senator Boxer as original cosponsors of this legislation.
  It is my hope that in this Congress we can make some positive changes 
in this important area.

[[Page S3838]]

  Let me start by explaining what the Preservation of Antibiotics for 
Medical Treatment Act does.
  The Preservation of Antibiotics for Medical Treatment Act directs the 
Food and Drug Administration to regulate the misuse of antibiotics in 
agriculture. It requires drug companies and producers to demonstrate 
that they are using antibiotics to treat clinically diagnosable 
diseases in farm animals. It requires that companies defend the process 
of adding gross amounts of antibiotics to the feed and water of 
livestock and it requires them to prove that this practice does not 
contribute to antibiotic-resistance among humans.
  Unfortunately, it has become a common practice in industrial 
agriculture to use antibiotics for ``growth promotion.'' This practice 
allows for animals kept in cramped quarters to grow artificially fast, 
and artificially fat.
  The most concerning part is that the low doses of antibiotics fed to 
these animals breed antibiotic resistant pathogens. These pathogens 
make their way into our food, our water, and our communities.
  Antibiotic resistance is one of the most significant public health 
challenges facing us today, and numerous peer-reviewed studies have 
concluded that the overuse of antibiotics in animal agriculture is 
making the problem worse.
  A recent study published in the medical journal Clinical Infectious 
Diseases found that nearly 50 percent of grocery store meat was 
contaminated with antibiotic resistant pathogens. Even more concerning, 
25 percent of all meat was contaminated with pathogens that were 
resistant to three or more types of antibiotics.
  I have heard for years that antibiotics were the closest thing to a 
``silver bullet'' in human medicine. But today, tens of thousands of 
people in the U.S. die each year from antibiotic resistant infections. 
So unfortunately we are learning the hard way that these precious, life 
saving drugs no longer work as well as they once did.
  Antibiotic resistance is a real and growing problem, and its causes 
are man-made.
  As our use of antimicrobial drugs has increased, so has the ability 
of bacteria to withstand their effects. The only way to preserve the 
effectiveness of antibiotics is to use them responsibly.
  In human medicine, this means that doctors must use better discretion 
when prescribing antibiotics. As patients, we must do our part and 
finish the prescriptions given to us.
  But antibiotics are also used in animal medicine, so veterinarians 
and farmers must also ensure that antibiotics are used responsibly.
  I was surprised to learn that the Union of Concerned Scientists 
estimates that 84 percent of all antibiotic usage in this country is in 
animals such as chickens, pigs, and cattle. Even more surprising is the 
vast majority of antibiotic consumption by livestock is by animals that 
show no clinical signs of illness.
  This type of treatment, referred to by doctors and veterinarians as 
non-therapeutic, creates the perfect breeding ground for antibiotic 
resistant bacteria. Unlike therapeutic doses of medicine that are 
prescribed when we, or any other animal gets sick, non-therapeutic 
doses of antibiotics are routinely added to the food or water of 
livestock that are not ill.
  These doses are not large enough, or powerful enough, to eliminate 
all the bacteria inside their bodies. Instead, the small dose of 
antibiotics only kills off the weakest bacteria; leaving the strongest, 
most resistant bacteria behind to reproduce.
  Recognizing the impending health crisis, some have taken dramatic 
action. In 1998, Denmark became the first country to ban the routine 
use of antibiotics in the food and water of livestock. The entire 
European Union followed suit in 2006. Australia, New Zealand, Chile, 
Korea, Thailand, the Philippines, and Japan have also implemented full 
or partial bans on non-therapeutic uses of antibiotics.
  But the majority of producers in the U.S. have not followed suit; and 
it is time for a wakeup call.
  That is why I am reintroducing the Preservation of Antibiotics for 
Medical Treatment Act. This legislation implements a precautionary 
principle when it comes to using antibiotics and requires that 
producers and drug companies affirmatively demonstrate that the non-
therapeutic antibiotics in livestock production do not contribute to 
the incidence of antibiotic resistant infections in humans.
  Put simply, if growth promoting antibiotics can't be used safely, 
they shouldn't be used at all.
  The real strength of this legislation is that it takes an incremental 
approach. The new regulations regarding antibiotic use under PAMTA 
would only apply to the limited number of antibiotics that are critical 
to human health and are used non-therapeutically.
  This means that any drug not used in human medicine is left untouched 
by this legislation.
  PAMTA also preserves the ability of farmers to use all available 
antibiotics to treat sick animals.
  By focusing on only the most egregious misuses of medically important 
antibiotics, PAMTA tackles the problem of antibiotic resistance where 
we know we can make the most difference.
  I understand that some question the need for this legislation; they 
say that there is no evidence that antibiotic use in agriculture leads 
to infections in humans.
  Unfortunately they are wrong.
  Rear Admiral Ali S. Khan, MD, MPH, Assistant Surgeon General and 
Director of the Office of Public Health Preparedness and Response at 
the Centers for Disease Control and Prevention recently testified in 
front of the House Energy Committee that ``studies related to 
Salmonella as both a human and animal pathogen, including many studies 
in the United States, have demonstrated that use of antibiotic agents 
in food animals results in antibiotic resistant bacteria in food 
animals, resistant bacteria are present in the food supply and are 
transmitted to humans, and resistant bacterial infections result in 
adverse human health consequences, e.g., increased hospitalization.
  Doctor Joshua Sharfstein, Principal Deputy Commissioner of the Food 
and Drug Administration also testified at the hearing and agreed with 
Rear Admiral Khan. The FDA, he said, ``supports the conclusion that 
using medically important antimicrobial drugs for production purposes 
is not in the interest of protecting and promoting the public health.''
  Quantitative evidence from the EU and Canada also support these 
conclusions. In response to public health concerns about the rise of 
cephalosporin, an antibiotic, resistance in Salmonella and E. coli, 
chicken hatcheries in Quebec voluntarily stopped using the drug in 
February 2005. Following the ban, the public health agency of Canada 
reported a dramatic 89 percent decrease in the incidence of resistant 
salmonella in chicken meat and 77 percent decrease in related human 
infections. Once the drug was partially reintroduced in 2007, 
antibiotic resistant infections in people jumped back up 50 percent.

  Unfortunately we are fighting an uphill battle with antibiotic 
resistant infections. Our tools and resources are diminishing even 
while the number and severity of these infections are increasing.
  One example is Methicillin-resistant Staphylococcus aureus, or MRSA. 
According to the Centers for Disease Control and Prevention, CDC, MRSA 
infections in 1974 accounted for only two percent of the total number 
of staph infections; in 1995 it was 22 percent; and by 2004 it was 63 
percent.
  CDC estimates that by 2005, there were 94,360 MRSA infections in the 
United States. Tragically, about 19,000 of them, 20 percent, were fatal 
because MRSA is nearly immune to almost every antibiotic used in modern 
medicine.
  By comparison, in 2005 there were 17,011 deaths due to AIDS; so the 
scope and consequence of this problem is stunning.
  Of course not all MRSA is derived from the overuse of antibiotics on 
the farm. Many infections are acquired in the hospital, and it is 
believed that these bacteria became resistant to antibiotics due to the 
misuse of drugs in human medicine.
  But MRSA is also infecting individuals who have not been in a 
hospital setting.
  There is strong evidence that at least one strain of MRSA infecting 
people is

[[Page S3839]]

coming directly from livestock. This strain, known as ST398, has been 
shown to disproportionately infect farmers and their families. Like all 
MRSA, ST398 is resistant to the antibiotics methicillin and oxacillin. 
But resistance to other antibiotics is also common among ST398 strains, 
which makes treatment especially challenging.
  A recent study by the CDC in December 2009 showed that hospital 
acquired strains of MRSA and community acquired MRSA strains such as 
ST398 are trending in opposite directions.
  The study found that community acquired MRSA, a type of MRSA that did 
not emerge in the hospital setting and is not contracted there, 
increased 700 percent between 1999 and 2006.
  By contrast, hospital acquired MRSA cases declined roughly 10 percent 
over this same time period.
  Over the past decade, it has become clear that MRSA is not just a 
problem for hospital administrators. More and more individuals are 
acquiring this devastating infection in their homes, at their gyms or 
in restaurants.
  While it is exceedingly difficult to determine the exact extent that 
antibiotic use in agriculture influences individual MRSA cases, we know 
for certain that statistical evidence overwhelmingly suggests that a 
reduction of antibiotic use in agriculture will result in a reduction 
of highly resistant MRSA cases.
  Since the Union of Concerned Scientists estimates that as much as 84 
percent of all antibiotic usage in this country is in veterinary 
medicine, one can reasonably conclude that a reduction of antibiotic 
use in agriculture will result in a reduction of highly resistant MRSA 
cases.
  The reason I am so committed to this legislation is that a reduction 
in highly resistant infections will save lives. One of my constituents 
shared a truly heartbreaking story.
  The Don family, from Ramona, California, is a tight knit family. They 
are active in the community, and loved by their neighbors. Until 
recently, like most happy, healthy families, antibiotic resistant 
infections just wasn't a subject that came up much.
  So when Mr. and Mrs. Don sent their son Carlos off to sixth grade 
camp in 2007, they never expected that an antibiotic resistant 
infection would change their lives.
  Carlos was the picture of health. He was a bright, vibrant, athletic 
12-year old, who loved to play football.
  When he returned home from camp, he had a 104 degree fever and could 
barely walk. It was the sickest his parents had ever seen him.
  When Carlos didn't get better the next day, they took him to Urgent 
Care. He was given a dose of antibiotics that the doctors said would 
knock the bug out in a few days.
  But the drugs didn't work.
  The next day Carlos was in even worse shape and he had to be rushed 
to the hospital by an ambulance. His new doctors put him on every 
single antibiotic the hospital had to offer.
  Even at the extremely high levels prescribed to Carlos, the drugs 
still didn't work.
  It took doctors 48 hours to find and acquire an antibiotic that was 
strong enough to kill the infection.
  By that time Carlos' lungs, kidneys, liver, intestines and heart had 
all failed.
  The only thing left, doctors told his parents, was his brain. The 
doctors said that Carlos knew his body was failing and that he was in a 
fight for his life.
  It pains me to say that this story does not have a happy ending. 
Carlos lost his life because the antibiotics that we have relied on for 
80 years didn't work.
  No parents should ever have to undergo the heartbreak and the tragedy 
that the Dons went through in 2007.
  Their son was as healthy and happy as any 12-year-old could be, but 
he was cruelly taken away from them because of a disease that we could 
not fight.
  I believe that with this bill we have an opportunity to prevent other 
families from suffering from this same tragic story.
  There are some who believe this legislation may actually make our 
food supply less safe. Their argument is that antibiotics keep our 
animals healthy, and healthy animals make for healthy food.
  But research shows us that these concerns are misguided. Over 375 
public, consumer, and environmental health groups including the 
American Medical Association, the American Public Health Association, 
and the Infectious Diseases Society of America, support the legislation 
because they believe that reducing antibiotic use in agriculture will 
protect the health and safety of Americans.
  It is not just health groups that support this approach. The fact is 
that farmers and meat producers can keep their animals healthy without 
adding hundreds of pounds of antibiotics to the food and water of their 
animals.
  In Denmark, one of the world's largest exporters of pork, producers 
have made modest changes to their husbandry practices and reduced 
overall antibiotic use by over 50 percent. Pork production has grown, 
and other animal health indicators such as litter size and average 
daily weight gain have improved.
  In Iowa, hog farmers like Paul Willis and Jude Becker have shown that 
antibiotic-free production is possible in the heartland of America too.
  In California, companies like Niman Ranch in Alameda have proved that 
Beef, Pork, Poultry and Lamb can be produced profitably in America on a 
large scale without the routine use of antibiotics. In fact, fast-food 
chain Chipotle Mexican Grill has grown a highly successful business 
based on meats raised without antibiotics, much of it supplied by Niman 
Ranch.
  This bipartisan bill makes incremental changes to ensure that our 
actions on the farm do not negatively impact the health and well being 
of our farmers, their families, and every one of us who consumes the 
food they produce.
  I look forward to working with my colleagues to pass these critical 
reforms.
  Mr. President, I ask unanimous consent that the text of the bill be 
printed in the Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                S. 1211

       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 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) 1,300,000 kilograms of antibacterial drugs were sold 
     for use on food animals in the United States in 2009;
       (B) 3,300,000 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

[[Page S3840]]

     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;''; 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, 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

[[Page S3841]]

     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, 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 Health, 
     Education, Labor, and Pensions 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 that House) at any time, in the same manner, and 
     to the same extent as in the case of any other rule of that 
     House.

                          ____________________