,,ii #aacth ,,congress #ast ,session ,s4 #abef ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,june #bg1 #bjac ,mrs4 ,feinstein 7for herself1 ,ms4 ,collins1 ,mr4 ,reed1 ,ms4 ,cantwell1 and ,mrs4 ,boxer7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to preserve the effectiveness of medically important antimicrobials used in the treatment of human and animal diseases4 #a4 ,short title ,this ,act may be cited as the ,preventing ,antibiotic ,resistance ,act of #bjac4 #b4 ,findings ,the ,congress finds the following3 7#a7 7,a7 ,in #aigg1 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 bacteria4 ,however1 the ,food and ,drug ,administration did not act in response to these findings1 despite laws requiring the agency to do so4 7,b7 ,in #bjab1 the ,food and ,drug ,administration was ordered by a ,federal court to address the use of antibiotics in livestock1 as the result of a lawsuit filed against the agency citing the agency's failure to act in response to the #aigg findings4 7#b7 7,a7 ,in #aiih1 the ,national ,academy of ,sciences noted that antibiotic-resistant bacteria generate a minimum of #d1jjj1jjj1jjj to #e1jjj1jjj1jjj in costs to ,united ,states society and individuals yearly4 7,b7 ,in #bjji1 ,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 #af1fjj1jjj1jjj and #bf1jjj1jjj1jjj annually4 7#c7 ,an ,april #aiii study by the ,government ,accountability ,office concluded that resistant strains of #c microorganisms that cause foodborne illness or disease in humans 7,salmonella1 ,campylobacter1 and ,e4 coli7 are linked to the use of antibiotics in animals4 7#d7 7,a7 ,large-scale1 voluntary surveys by the ,department of ,agriculture's ,animal and ,plant ,health ,inspection ,service in #aiii1 #bjja1 and #bjjf revealed that-- 7i7 #hd percent of grower-finisher swine farms1 #hc percent of cattle feedlots1 and #hd percent of sheep farms administer antimicrobials in the feed or water for health or growth promotion reasons2 and 7ii7 many of the antimicrobials identified are identical or closely related to drugs used in human medicine1 including tetracyclines1 macrolides1 ,bacitracin1 penicillins1 and sulfonamides4 7,b7 ,such drugs are used in people to treat serious diseases such as pneumonia1 scarlet fever1 rheumatic fever1 sexually transmitted infections1 skin infections1 and even pandemics like malaria and plague1 as well as bioterrorism agents such as anthrax4 7#e7 7,a7 ,any overuse or misuse of antibiotics contributes to the spread of antibiotic resistance1 whether in human medicine or in agriculture4 7,b7 ,recognizing the public health threat caused by antibiotic resistance1 ,congress took several steps to curb antibiotic overuse in human medicine through amendments to the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bja et seq47 made by section #ajb of the ,public ,health ,threats and ,emergencies ,act 7,public ,law #ajf-eje2 #aad ,stat4 #bcae71 but has not yet addressed antibiotic overuse in agriculture4 7#f7 ,in ,january #bjja1 a ,federal interagency task force-- 7,a7 released an action plan to address the continuing decline in effectiveness of antibiotics against common bacterial infections1 referred to as antibiotic resistance2 7,b7 determined that antibiotic resistance is a growing menace to all people and poses a serious threat to public health2 and 7,c7 cautioned that if current trends continue1 treatments for common infections will become increasingly limited and expensive1 and1 in some cases1 nonexistent4 7#g7 ,the ,united ,states ,geological ,survey reported in ,march #bjjb that-- 7,a7 antibiotics were present in #dh percent of the streams tested nationwide2 and 7,b7 almost half of the tested streams were downstream from agricultural operations4 7#h7 ,the peer-reviewed journal ,clinical ,infectious ,diseases published a report in ,june #bjjb that-- 7,a7 was based on a #b-year review by experts in human and veterinary medicine1 public health1 microbiology1 biostatistics1 and risk analysis1 of more than #ejj scientific studies on the human health impacts of antimicrobial use in agriculture2 and 7,b7 recommended that antimicrobial agents should no longer be used in agriculture in the absence of disease1 but should be limited to therapy for diseased individual animals and prophylaxis when disease is documented in a herd or flock4 7#i7 ,in a ,march #bjjc report1 the ,national ,academy of ,sciences stated that-- 7,a7 a decrease in antimicrobial use in human medicine alone will have little effect on the current situation2 and 7,b7 substantial efforts must be made to decrease inappropriate overuse in animals and agriculture4 7#aj7 ,the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47-- 7,a7 requires that all drugs be shown to be safe before the drugs are approved2 and 7,b7 places the burden on manufacturers to account for health consequences and prove safety4 7#aa7 7,a7 ,in #bjjc1 the ,food and ,drug ,administration modified the drug approval process for antibiotics to recognize the development of resistant bacteria as an important aspect of safety1 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 process4 7,b7 ,the ,food and ,drug ,administration has not established a schedule for reviewing those existing approvals4 7#ab7 7,a7 ,in an ,april #bjjd report1 the ,government ,accountability ,office-- 7i7 concluded that ,federal agencies do not collect the critical data on antibiotic use in animals that they need to support research on human health risks2 and 7ii7 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 animals4 7,b7 ,in a ,september #bjaa update to that report1 the ,government ,accountability ,office-- 7i7 concluded that ,federal agencies had made limited progress in addressing antibiotic use in animals2 7ii7 recommended that ,federal agencies fund research on alternatives to current antibiotic use practices2 and 7iii7 recommended that ,federal agencies track the effectiveness of policies that curb antibiotic resistance1 including the ,food and ,drug ,administration's voluntary guidelines reducing antibiotic use in food animals4 7#ac7 ,in #bjji1 the ,congressional ,research ,service concluded that1 without restrictions on the use of antimicrobial drugs in the production of livestock1 export markets for livestock and poultry could be negatively impacted due to restrictions on the use of antibiotics in other nations4 7#ad7 ,in #bjaj1 the peer-reviewed journal ,molecular ,cell published a study demonstrating that low-dosage use of antibiotics causes a dramatic increase in genetic mutation1 raising new concerns about the agricultural practice of using low-dosage antibiotics in order to stimulate growth promotion and routinely prevent disease in unhealthy conditions4 7#ae7 ,in #bjaj1 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 species1 including ,campylobacter and ,enterococci4 7#af7 ,in #bjaa1 the ,food and ,drug ,administration determined that-- 7,a7 #ac1ejj1jjj kilograms of antibacterial drugs were sold for use on food animals in the ,united ,states in #bjaj2 7,b7 #c1cjj1jjj kilograms of antibacterial drugs were used for human health in #bjaj2 and 7,c7 #hj percent of antibacterial drugs disseminated in the ,united ,states in #bjaj were sold for use on food animals1 rather than being used for human health4 7#ag7 ,in #bjaa1 a review of all scientific studies on antimicrobial use in farm animals1 published in ,clinical ,microbiology ,reviews1 found that-- 7,a7 use of antibiotics in food animals leads to development of reservoirs of antibiotic resistance2 7,b7 a ban on nontherapeutic antibiotic use in food animals would preserve the use of such antibiotics for medicine2 and 7,c7 a ,danish ban on nontherapeutic antibiotics in food animals resulted in little change in animal morbidity and mortality1 and only a modest increase in production cost4 7#ah7 ,in ,april #bjab1 the ,food and ,drug ,administration issued voluntary guidance to industry on reducing antibiotic use in livestock and poultry4 ,as part of that guidance1 it summarized over #ce years of peer-reviewed scientific literature regarding use of antimicrobial drugs in livestock4 ,as a result1 the ,food and ,drug ,administration stated strategies for controlling antibiotic resistance are needed1 and are seeking voluntarily limits on antibiotic use4 7#ai7 7,a7 ,in ,january #bjac1 ,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 illnesses4 ,a #bjjc ,consumer ,report study showed similar results in poultry products4 7,b7 ,the ,food and ,drug ,administration's ,national ,antimicrobial ,resistance ,monitoring ,system routinely finds that retail meat products are contaminated with bacteria 7including the foodborne pathogens ,campylobacter and ,salmonella7 that are resistant to antibiotics important in human medicine4 ,the #bjaa ,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 resistance4 7#bj7 ,antibiotic resistance1 resulting in a reduced number of effective antibiotics1 may significantly impair the ability of the ,united ,states to respond to terrorist attacks involving bacterial infections or a large influx of hospitalized patients4 7#ba7 ,many scientific studies confirm that the nontherapeutic use of antibiotics in agricultural animals contribute to the development of antibiotic-resistant bacterial infections in people4 7#bb7 ,epidemiological research has shown that resistant ,salmonella and ,campylobacter infections are associated with increased numbers of ill patients and bloodstream infections1 and increased death4 7#bc7 ,the ,american ,medical ,association1 the ,american ,public ,health ,association1 the ,national ,association of ,county and ,city ,health ,officials1 and the ,national ,sustainable ,agriculture ,coalition are among the more than #djj organizations representing health1 consumer1 agricultural1 environmental1 humane1 and other interests that have supported enactment of legislation to phase out nontherapeutic use in farm animals of medically important antimicrobials4 #c4 ,purpose ,the purpose of this ,act is to preserve the effectiveness of medically important antimicrobials used in the treatment of human and animal diseases4 #d4 ,proof of safety of medically important antimicrobials 7a7 ,applications pending or submitted after enactment ,section #eab7;d77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;b7d77#a77 is amended-- 7#a7 in the first sentence-- 7,a7 in subparagraph 7,h71 by striking or at the end2 7,b7 in subparagraph 7,i71 by inserting or at the end2 and 7,c7 by inserting after subparagraph 7,i7 the following3 7,j7 with respect to a medically important antimicrobial 7as defined in subsection 7q771 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 attributable1 in whole or in part1 to the nontherapeutic use 7as defined in subsection 7q77 of the medically important antimicrobial or drug2 2 and 7#b7 in the second sentence1 by striking 7,a7 through 7,i7 and inserting 7,a7 through 7,j74 7b7 ,phased elimination of nontherapeutic use in animals of medically important antimicrobials ,section #eab of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;b7 is amended by adding at the end the following3 7q7 ,phased elimination of nontherapeutic use in animals of medically important antimicrobials 7#a7 ,applicability ,this subsection applies to the nontherapeutic use in a food-producing animal of a drug-- 7,a7 that is a medically important antimicrobial2 7,b7 for which there is in effect an approval of an application or an exemption under subsection 7b71 7i71 or 7j7 of section #eje2 or 7,c7 that is otherwise marketed for human use4 7#b7 ,withdrawal ,the ,secretary shall withdraw the approval of a nontherapeutic use in food-producing animals of a drug described in paragraph 7#a7 on the date that is #b years after the date of enactment of this subsection unless-- 7,a7 before the date that is #b years after the date of the enactment of this subsection1 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 drug2 or 7,b7 before the date specified in subparagraph 7,a71 the ,secretary makes a final written determination under this subsection1 with respect to a risk analysis of the drug conducted by the ,secretary and other relevant information1 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 drug4 7#c7 ,exemptions ,except as provided in paragraph 7#e71 if the ,secretary grants an exemption under section #eje7;i7 for a drug that is a medically important antimicrobial1 the ,secretary shall rescind each approval of a nontherapeutic use in a food-producing animal of the medically important antimicrobial1 effective on the date that is #b years after the date on which the ,secretary grants the exemption4 7#d7 ,approvals ,except as provided in paragraph 7#e71 if an application for a drug that is a medically important antimicrobial is submitted to the ,secretary under section #eje7;b71 the ,secretary shall rescind each approval of a nontherapeutic use in a food-producing animal of the medically important antimicrobial1 effective on the date that is #b years after the date on which the application is submitted to the ,secretary4 7#e7 ,exceptions ,paragraph 7#c7 or 7#d71 as applicable1 shall not apply if-- 7,a7 before the date on which approval would be rescinded under that paragraph1 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 antimicrobial2 or 7,b7 before the date specified in subparagraph 7,a71 the ,secretary makes a final written determination1 with respect to a risk analysis of the medically important antimicrobial conducted by the ,secretary and any other relevant information1 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 antimicrobial4 7#f7 ,definitions ,in this subsection3 7,a7 ,the term medically important antimicrobial means a drug that-- 7i7 is intended for use in food-producing animals2 and 7ii7 is composed wholly or partly of-- 7,i7 any kind of penicillin1 tetracycline1 macrolide1 lincosamide1 streptogramin1 aminoglycoside1 sulfonamide1 or cephalosporin2 or 7,,ii7 a drug from an antimicrobial class that is listed as highly important1 critically important1 or important by the ,world ,health ,organization in the latest edition of its publication entitled ,critically ,important ,antimicrobials for ,human ,medicine 7or a successor publication74 7,b7 ,the term therapeutic use1 with respect to a medically important antimicrobial1 means the use of antimicrobials for the specific purpose of treating an animal with a documented disease or infection4 ,such term does not include the continued use of such an antimicrobial in the animal after the disease or infection is resolved4 7,c7 ,the term nontherapeutic use-- 7i7 means administration of antibiotics to an animal through feed or water 7or1 in poultry hatcheries1 through any means7 for purposes 7such as growth promotion1 feed efficiency1 weight gain1 or disease prevention7 other than therapeutic use or nonroutine disease control2 and 7ii7 includes any repeated or regular pattern of use of medically important antimicrobials for purposes other than therapeutic use or nonroutine disease control4 7,d7 ,the term noncustomary situation does not include normal or standard practice and conditions on the premises that facilitate the transmission of disease4 7,e7 ,the term nonroutine disease control means the use of antibiotics in the feed or water of an animal that is not sick1 where it can be shown that a particular disease or infection is1 or is likely to be1 present on the premises because of a specific1 non-customary situation4 4 #e4 ,limitations on use of medically important antimicrobials for nonroutine disease control 7a7 ,prohibited acts ,section #cja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7 is amended by adding at the end the following3 7ccc7 ,the administration of a medically important antimicrobial to a food-producing animal for nonroutine disease control in violation of the requirements of section #eab;,a4 4 7b7 ,requirements ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended by inserting after section #eab of such ,act 7#ba ,u4,s4,c4 #cfj;b7 the following3 #eab;,a4 ,limitations on use of medically important antimicrobials for nonroutine disease control 7a7 ,prohibition ,it shall be unlawful to administer 7including by means of animal feed7 a medically important antimicrobial to a food-producing animal for nonroutine disease control unless-- 7#a7 7,a7 there is a significant risk that a disease or infection present on1 or likely present on1 the premises will be transmitted to the food-producing animal2 7,b7 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 7#a72 7,c7 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 7#a7 to the animal2 and 7,d7 the medically important antimicrobial is administered-- 7i7 at a scale no greater than the barn1 house1 or pen level2 and 7ii7 to the fewest animals possible to prevent or reduce the risk of transmission of the disease or infection described in paragraph 7#a72 or 7#b7 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 health4 7b7 ,definitions ,in this section3 7#a7 ,the term food-producing animal means a food-producing animal intended for sale in interstate commerce4 7#b7 ,the terms medically important antimicrobial and nonroutine disease control have the meanings given such terms in section #eab7q74 4 7c7 ,applicability ,the amendments made by this section apply beginning on the date that is #b years after the date of the enactment of this ,act4 #f4 ,sense of the ,senate regarding veterinary oversight of use of medically important antimicrobials 7a7 ,in general ,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 practices4 7b7 ,veterinarian-,client-,patient relationship ,in ths section1 the term veterinarian-client-patient relationship means a relationship in which all of the following criteria are met3 7#a7 ,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 instructions4 7#b7 ,the veterinarian has sufficient knowledge of the patient to initiate at least a general or preliminary diagnosis of the medical condition of the patient4 ,this means that the veterinarian is personally acquainted with the keeping and care of the patient by virtue of-- 7,a7 a timely examination of the patient by the veterinarian2 or 7,b7 medically appropriate and timely visits by the veterinarian to the premises where the animal or animals are kept4 7#c7 ,the veterinarian is readily available for follow-up evaluation or has arranged for veterinary emergency coverage and continuing care and treatment4 7#d7 ,the veterinarian provides oversight of treatment1 compliance1 and outcome4 7#e7 ,patient records are maintained4