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A03493 Summary:

BILL NOA03493B
 
SAME ASSAME AS S02871-A
 
SPONSORRosenthal L
 
COSPNSRSteck, Epstein, Colton, Griffin, Gottfried, Niou, Simon, Cook, Seawright, Taylor, Gallagher, Kelles
 
MLTSPNSREnglebright
 
Add Art 135-A §§6720 - 6728, Ed L; add §97-j, St Fin L
 
Protects medically important antimicrobials for human public health; establishes a livestock producer may provide a medically important antimicrobial to a food-producing animal only if a licensed veterinarian, in the exercise of professional judgment, determines that the provision of the medically important antimicrobial to the animal is necessary: to control the spread of a disease or infection, to treat a disease or infection, or in relation to surgical or other medical procedures; requires veterinarians licensed to practice in New York state to file an annual report detailing their prescribing history of medically important antimicrobials to food-producing animals.
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A03493 Actions:

BILL NOA03493B
 
01/27/2021referred to higher education
02/03/2021amend and recommit to higher education
02/03/2021print number 3493a
05/03/2021amend and recommit to higher education
05/03/2021print number 3493b
01/05/2022referred to higher education
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A03493 Memo:

NEW YORK STATE ASSEMBLY
MEMORANDUM IN SUPPORT OF LEGISLATION
submitted in accordance with Assembly Rule III, Sec 1(f)
 
BILL NUMBER: A3493B
 
SPONSOR: Rosenthal L
  TITLE OF BILL: An act to amend the education law and the state finance law, in relation to protecting medically important antimicrobials for human public health   PURPOSE: The aim of this act is to eliminate the overuse and misuse of medically important antimicrobials in food-producing animals to reduce the devel- opment and spread of antimicrobial resistance and antimicrobial-resis- tant infections in humans, and to preserve the effectiveness of medically important antimicrobials for future generations.   SUMMARY OF SPECIFIC PROVISIONS: Section 1 of the bill sets forth legislative findings. Section 2 of the bill amends the education law by adding a new Article 135-A. Section 3 of the bill amends the state finance law by adding a section 97-j, which creates an "Antibiotics Education Fund" administered by the state comptroller, consisting of all monies recovered from penalties and fines authorized by Article 14-B. Section 4 of the bill sets forth the effective date.   JUSTIFICATION: In the U.S., a majority of FDA-approved medically important antimicrobi- als (primarily antibiotics) are also sold for use in food-producing animals, including cattle, dairy cows, pigs, and turkeys. Most of these animals are not actually sick, but the routine administration of antibi- otics in their food and/or water allows them to survive their often overcrowded and unsanitary living conditions. Overuse and misuse of antibiotics in food-producing animals is a driver of the development of bacteria that are resistant to those same antibi- otics - drugs that are critical to human health. Antibiotic resistance is a naturally occurring phenomenon, but the opportunities for its development and spread increases when bacteria are repeatedly exposed to antibiotics such as they are in food-producing animals. The antibiotics kill off the bacteria that don't have resist- ance, but those that do have it multiply and spread. Antibiotic-resis- tant bacteria can travel easily from farm settings to people. They can contaminate food, air, and water. They spread easily between people via skin-to-skin contact, coughing, sneezing, poor hygiene, and sharing of personal items. Antibiotic-resistant bacteria can also transfer their resistance to other bacteria, making them resistant to medically impor- tant antibiotics, too. The World Health Organization, the United Nations General Assembly, the U.S. Centers for Disease Control and Prevention, the New York State Department of Health, and many other major public health organizations have recognized antibiotic-resistant infections as a public health crisis. Currently in the U.S., at least 2,000,000 get ill and as many as 162,000 die per year from antibiotic-resistant infections. A recent study sponsored by the British government predicted 10 million deaths per year worldwide by 2050 - more than from cancer - if progress is not made in the fight against antibiotic resistance. While overuse in medical settings is a primary contributor to the devel- opment and spread of antibiotic resistance, overuse and misuse in agri- culture creates resistant superbugs that infect people via food, water, airborne dust, and worker exposure. According to the CDC, approximately400,000 Americans get sick each year by eating food contam- inated with antibiotic-resistant bacteria and 20% of all antibiotic-re- sistant infections are caused by germs from food and animals. Left unchallenged, the threat of antibiotic resistance may return us to an era where strep throat, tuberculosis, childbirth, tooth infections, skin scrapes, and routine surgery are associated with high rates of mortal- ity. With a lack of meaningful regulation at the federal level, states like New York must take action to preserve the effectiveness of medically important antibiotics for ourselves and future generations.   LEGISLATIVE HISTORY: 2019-20: A.9632 - Referred to Higher Education; S.5742-A - Referred to Higher Education   FISCAL IMPLICATIONS: None.   EFFECTIVE DATE: July 1st next succeeding the date on which it shall have become law.
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A03493 Text:



 
                STATE OF NEW YORK
        ________________________________________________________________________
 
                                         3493--B
 
                               2021-2022 Regular Sessions
 
                   IN ASSEMBLY
 
                                    January 27, 2021
                                       ___________
 
        Introduced  by  M.  of A. L. ROSENTHAL, STECK, EPSTEIN, COLTON, GRIFFIN,
          GOTTFRIED, NIOU, SIMON, COOK -- Multi-Sponsored by -- M. of A.  ENGLE-
          BRIGHT  -- read once and referred to the Committee on Higher Education
          -- committee discharged, bill amended, ordered  reprinted  as  amended
          and  recommitted  to  said  committee  --  committee  discharged, bill
          amended, ordered reprinted as amended and recommitted to said  commit-
          tee
 
        AN ACT to amend the education law and the state finance law, in relation
          to  protecting  medically  important  antimicrobials  for human public
          health
 
          The People of the State of New York, represented in Senate and  Assem-
        bly, do enact as follows:
 
     1    Section  1.  Legislative  findings.  The legislature declares that the
     2  overuse and misuse of medically important antimicrobials poses a serious
     3  public health threat.
     4    The World Health Organization has stated that "without urgent, coordi-
     5  nated action by many stakeholders, the world is headed for a  post-anti-
     6  biotic  era,  in  which  common infections and minor injuries which have
     7  been treatable for decades can once again kill." In 2016, members of the
     8  UN General Assembly adopted a political declaration  acknowledging  that
     9  "the resistance of bacterial, viral, parasitic and fungal microorganisms
    10  to  antimicrobial medicines that were previously effective for treatment
    11  of infections is mainly due to: the inappropriate use  of  antimicrobial
    12  medicines  in  public  health, animal, food, agriculture and aquaculture
    13  sectors; ... resistance to antibiotics, which are not like  other  medi-
    14  cines  ...  is  the  greatest  and  most  urgent  global risk, requiring
    15  increased attention and coherence at  the  international,  national  and
    16  regional levels."
    17    The  legislature  further  finds  that overuse and misuse of medically
    18  important antimicrobials in livestock production is a significant compo-
    19  nent of the threat posed. The United States Food and Drug Administration

         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD00777-05-1

        A. 3493--B                          2
 
     1  and the Centers for Disease Control  and  Prevention  have  stated  that
     2  there  is  a definitive link between the routine use of medically impor-
     3  tant antimicrobials on industrial farms and the crisis  of  antimicrobi-
     4  al-resistant infections in humans.
     5    The  issue  of  antimicrobial misuse and overuse, whether in people or
     6  animals, is a significant and urgent public health matter.
     7    It has been estimated that seventy percent of all antimicrobials  sold
     8  in  the  United  States  are for use in food-producing animals, often to
     9  compensate for the effects of unsanitary and overcrowded  conditions  on
    10  farms.
    11    Many  of  the  antimicrobials  provided  to food-producing animals are
    12  identical to, or from the same class as, drugs used in human medicine to
    13  treat serious conditions (i.e., medically important drugs). Thus,  anti-
    14  microbial-resistant  bacteria that emerge and spread from food-producing
    15  animals in farm settings to infect humans can be very dangerous  because
    16  the  antibiotics  usually  used to treat the infections in humans may no
    17  longer be effective against them.
    18    The legislature further finds that,  as  with  any  use  of  medically
    19  important antimicrobials in animals, such use must be closely supervised
    20  by a New York state licensed veterinarian or those veterinarians author-
    21  ized  to  practice  within  the state. Moreover, that it is the licensed
    22  veterinarian who must ensure that the use of medically important antimi-
    23  crobials is appropriate and necessary.
    24    The legislature therefore intends to place appropriate restrictions on
    25  the misuse and overuse of medically important  antimicrobials  in  food-
    26  producing animals by ensuring that veterinarians have the clear authori-
    27  ty to control the use of medically important antimicrobials in food-pro-
    28  ducing  animals in New York state and that their practices are following
    29  the best scientific evidence.
    30    The purpose of this act is to protect public health by preserving  the
    31  effectiveness  of  medically important antimicrobials now and for future
    32  generations by eliminating the use of those medicines in  food-producing
    33  animals for disease prevention, resulting in a reduction in the rise and
    34  spread  of  antimicrobial-resistant bacteria and antimicrobial-resistant
    35  infections in humans.
    36    § 2. The education law is amended by adding a  new  article  135-A  to
    37  read as follows:
    38                                ARTICLE 135-A
    39                   COMBATING ANTIMICROBIAL RESISTANCE ACT
    40  Section 6720. Short title.
    41          6721. Definitions.
    42          6722. Prohibition of certain antimicrobial administration.
    43          6723. Authorization of certain antimicrobial administration.
    44          6724. Annual reports.
    45          6725. Antimicrobial stewardship guidelines.
    46          6726. Implementation.
    47          6727. Authority to receive Veterinary Feed Directives.
    48          6728. Violations.
    49    §  6720.  Short title. This act shall be known and may be cited as the
    50  "combating antimicrobial resistance act of 2021."
    51    § 6721. Definitions. As used in this section:
    52    1. "Antimicrobial" means any substance of natural, semi-synthetic,  or
    53  synthetic  origin  that  at in vivo concentrations kills or inhibits the
    54  growth of microorganisms by interacting with a specific target. The term
    55  antimicrobial is a collective for antiviral, antibacterial,  antifungal,
    56  antiparasitic, and antiprotozoal agents.

        A. 3493--B                          3
 
     1    2.  "Antimicrobial  class"  means  antimicrobial  agents  with related
     2  molecular structures, often with a similar mode  of  action  because  of
     3  interaction  with  a  similar target and thus subject to a similar mech-
     4  anism of resistance.
     5    3. "Antimicrobial resistance (AMR)" means the ability of a microorgan-
     6  ism  to  multiply or persist in the presence of an increased level of an
     7  antimicrobial relative  to  the  susceptible  counterpart  of  the  same
     8  species.
     9    4. "Disease control" means administration of antimicrobial agents to a
    10  group of animals containing sick and healthy individuals (presumed to be
    11  infected),  to  minimize or resolve clinical signs of infectious disease
    12  and to prevent further spread of the disease.
    13    5. "Disease prevention" means administration of  antimicrobial  agents
    14  to  an  individual or a group of animals at risk of acquiring a specific
    15  infection or in a specific situation where infectious disease is  likely
    16  to occur if the antimicrobial agent is not administered.
    17    6.  (a)  "Disease  treatment"  means  administration  of antimicrobial
    18  agents to an individual or group of animals showing  clinical  signs  of
    19  infectious disease or that test positive for a disease.
    20    (b)  Disease  treatment  includes  selective  dry cow therapy, whereby
    21  individual dairy cows within a herd are determined, when entering a  dry
    22  cycle,  to  be  likely  infected  with  mastitis based on key indicators
    23  including their previous history of disease, somatic cell counts  and/or
    24  cell  cultures,  and  are  administered  antibiotics  as prescribed by a
    25  licensed veterinarian.
    26    7. "Food-producing animal" means:
    27    (a) All cattle, swine, or poultry, regardless of whether the  specific
    28  animal  is  raised  for the purpose of producing food for human consump-
    29  tion; or
    30    (b) Any animal of a  type  that  the  department  of  agriculture  and
    31  markets  identifies  by rule as livestock typically used to produce food
    32  for human consumption, including aquatic and amphibian species.
    33    8. "Livestock producer" means a person raising a food-producing animal
    34  for commercial purposes.
    35    9. "Medically important antimicrobial" means a drug that  is  composed
    36  in whole or in part of:
    37    (a)  A  form  of  the  antibiotic  classes of penicillin, tetracyline,
    38  macrolide, lincosamide, streptogramin, aminoglycoside,  sulfonamide,  or
    39  cephalosporin; or
    40    (b)  A  drug  from an antimicrobial class that is categorized as crit-
    41  ically important, highly important, or important  in  the  World  Health
    42  Organization list of Critically Important Antimicrobials for Human Medi-
    43  cine  (5th  Revision, 2016), or a subsequent revision or successor docu-
    44  ment issued by the World Health Organization that is recognized by  rule
    45  by the department of health.
    46    10.  "Veterinary Feed Directive" has the same definition as in section
    47  558.3 of title 21 of the code of federal regulations.
    48    § 6722. Prohibition of certain antimicrobial administration.    Begin-
    49  ning January first, two thousand twenty-three, medically important anti-
    50  microbials  shall  not be administered to a food-producing animal unless
    51  ordered by a licensed veterinarian who has visited  the  farm  operation
    52  within  the  previous  six  months, through a prescription or Veterinary
    53  Feed Directive, pursuant to a  veterinarian-client-patient  relationship
    54  that  meets  the requirements as defined by the New York state office of
    55  professions.

        A. 3493--B                          4
 
     1    § 6723. Authorization  of  certain  antimicrobial  administration.  1.
     2  Beginning January first, two thousand twenty-three, a livestock producer
     3  may  provide  a  medically  important  antimicrobial to a food-producing
     4  animal only if a licensed veterinarian, in the exercise of  professional
     5  judgment, determines that the provision of the medically important anti-
     6  microbial to the animal is necessary:
     7    (a) To control the spread of a disease or infection;
     8    (b) To treat a disease or infection; or
     9    (c) In relation to surgical or other medical procedures.
    10    2. (a) Medically important antimicrobials shall not be administered by
    11  any  person to food-producing animals solely for the purposes of promot-
    12  ing weight gain, improving feed efficiency, or disease prevention.
    13    (b) Blanket dry cow therapy, whereby all dairy cows in a herd entering
    14  a dry cycle are routinely administered an antibiotic to prevent clinical
    15  mastitis, is considered a method  of  disease  prevention,  and  is  not
    16  authorized.
    17    3.  A  veterinarian  who  determines that the provision of a medically
    18  important antimicrobial to a food-producing animal is  necessary  for  a
    19  purpose  described  in  this  section  shall specify an end date for the
    20  provision of the antimicrobial to the animal.
    21    4. A livestock producer may administer a medically  important  antimi-
    22  crobial to a food-producing animal only for the purpose as determined by
    23  a  licensed veterinarian under this article.  The livestock producer may
    24  provide the antimicrobial only for the duration specified by the veteri-
    25  narian.
    26    § 6724. Annual reports. 1. Veterinarians licensed to practice  in  New
    27  York state, or who are licensed in a bordering state and practice in the
    28  state,  and  who prescribe medically important antimicrobials or write a
    29  Veterinary Feed Directive for one or more sets of food-producing animals
    30  must file an annual report under this  section  in  a  form  and  manner
    31  required by the department by rule. This report will be submitted to the
    32  commissioner,  the  commissioner of health, the commissioner of agricul-
    33  ture and markets, the temporary president  of  the  senate,  the  senate
    34  minority leader, the speaker of the assembly, and the minority leader of
    35  the  assembly. If any medically important antimicrobials were prescribed
    36  to, provided to, or administered to food-producing  animals  during  the
    37  reporting  period, the annual report must contain the following informa-
    38  tion:
    39    (a) The total number of food-producing animals provided with medically
    40  important antimicrobials;
    41    (b) The name of each medically important antimicrobial provided;
    42    (c) The species of food-producing animals that were provided with each
    43  medically important antimicrobial;
    44    (d) The quantity of each medically important antimicrobial  prescribed
    45  to each species of food-producing animal;
    46    (e) The number of days that each medically important antimicrobial was
    47  intended to be provided to a food-producing animal;
    48    (f)  The  dosage  of  each  medically important antimicrobial that was
    49  intended to be provided to a food-producing animal;
    50    (g) The method for providing each medically important antimicrobial to
    51  a food-producing animal;
    52    (h) The purpose for providing each medically  important  antimicrobial
    53  to a food-producing animal; and
    54    (i)  The  disease  or  infection,  if  any,  that  was  intended to be
    55  controlled due to the provision of each medically important antimicrobi-
    56  al.

        A. 3493--B                          5
 
     1    2. For the purposes of  paragraph  (h)  of  subdivision  one  of  this
     2  section,  the  purpose for providing a medically important antimicrobial
     3  to a food-producing animal must be reported as:
     4    (a) Disease control; or
     5    (b) Disease treatment; or
     6    (c) Necessary for surgical or other medical procedures.
     7    3.  Information  reported  under  this section should be made publicly
     8  available by the department of health annually in an  online  searchable
     9  database  of  aggregated data.  Such database shall protect the identity
    10  of a licensed veterinarian, an individual farm or business.
    11    4. Information reported under this section is a public record  and  is
    12  not  subject  to  exemption from public disclosure as required under the
    13  New York state freedom of information law.
    14    5. The state board of veterinary medicine, the  department  of  health
    15  and  the department of agriculture and markets will consult as necessary
    16  to fulfill the requirements of this section.
    17    § 6725. Antimicrobial stewardship guidelines. 1. The  state  board  of
    18  veterinary  medicine, in consultation with the department of agriculture
    19  and markets, the department of  health,  universities,  and  cooperative
    20  extensions,  shall develop antimicrobial stewardship guidelines and best
    21  management practices for  veterinarians,  livestock  owners,  and  their
    22  employees who are involved with the administering of medically important
    23  antimicrobials  on  the proper use of medically important antimicrobials
    24  for disease treatment and control. The guidelines shall  include  scien-
    25  tifically  validated  practical  alternatives  to  the  use of medically
    26  important antimicrobials, including, but not limited  to,  good  hygiene
    27  and  management  practices. The guidelines shall be reviewed and updated
    28  periodically, as necessary.
    29    2. The state board of veterinary medicine shall consult with livestock
    30  producers, licensed veterinarians, and other  relevant  stakeholders  on
    31  ensuring  that  livestock  grown  in  rural areas with limited access to
    32  veterinary care have timely access to treatment.
    33    3. For the purposes of this section, "antimicrobial stewardship" is  a
    34  commitment to do all of the following:
    35    (a) To use medically important microbials only when necessary to treat
    36  or control disease;
    37    (b)  To  select  the appropriate medically important microbial and the
    38  appropriate dose, duration, and route of administration; and
    39    (c) To use medically important microbials for  the  shortest  duration
    40  necessary  and  allowable,  and to administer them to the fewest animals
    41  necessary.
    42    § 6726. Implementation. 1. The state board of veterinary medicine, the
    43  department of health, and the  department  of  agriculture  and  markets
    44  shall  coordinate  with the United States Department of Agriculture, the
    45  United States Food and Drug Administration, and the Centers for  Disease
    46  Control  and  Prevention to implement the expanded antimicrobial resist-
    47  ance surveillance efforts included  in  the  National  Action  Plan  for
    48  Combating  Antibiotic-Resistant Bacteria, and that the information gath-
    49  ered through this effort will help lead to a better understanding of the
    50  links between antimicrobial use patterns in livestock and  the  develop-
    51  ment of antimicrobial-resistant bacterial infections.
    52    2.  (a)  The department of health, the state board of veterinary medi-
    53  cine, the department of  agriculture  and  markets,  veterinarians,  and
    54  livestock  producers  shall  gather  information  on medically important
    55  antimicrobial sales and usage as well as antimicrobial-resistant  bacte-
    56  ria  and  livestock  management practice data.  Monitoring efforts shall

        A. 3493--B                          6
 
     1  not be duplicative of the National Animal Health  Monitoring  System  or
     2  the  National  Antimicrobial  Resistance  Monitoring System, and, to the
     3  extent feasible, will coordinate with the United  States  Department  of
     4  Agriculture,  the  Centers  for  Disease Control and Prevention, and the
     5  United States Food and Drug Administration in the development  of  these
     6  efforts.
     7    (b)  In coordinating with the National Animal Health Monitoring System
     8  and the National Antimicrobial Resistance Monitoring System, the depart-
     9  ment of health, the state board of veterinary medicine and  the  depart-
    10  ment  of  agriculture and markets shall gather representative samples of
    11  biological isolates from all of the following:
    12    (i) New York state's major livestock segments;
    13    (ii) regions with considerable livestock production; and
    14    (iii) representative segments of the food production chain.
    15    (c) The department of health, the state board of  veterinary  medicine
    16  and the department of agriculture and markets shall report to the legis-
    17  lature  by January first, two thousand twenty-four, the results of their
    18  outreach activities and monitoring efforts.
    19    § 6727. Authority to receive Veterinary Feed Directives.  The  depart-
    20  ment of agriculture and markets has the authority to request and receive
    21  copies of all Veterinary Feed Directives issued in the state from veter-
    22  inarians,  livestock owners, feed mills, or distributors to fully imple-
    23  ment the provisions of this article.
    24    § 6728. Violations. 1. A person or entity who  violates  this  article
    25  shall  be  liable  for  a civil penalty of not more than two hundred and
    26  fifty dollars per farm operation for each day a violation occurs.
    27    2. (a) For a second or subsequent violation, a person  or  entity  who
    28  violates  this  article shall be punishable by an administrative fine in
    29  the amount of five hundred dollars per farm operation  for  each  day  a
    30  violation occurs.
    31    (b)  In addition to the administrative fine, the violator shall attend
    32  an educational program to be jointly  developed  by  the  department  of
    33  health  and  the state board of veterinary medicine on the judicious use
    34  of medically important antimicrobials. The violator  shall  successfully
    35  complete  the  program and provide proof to the board within ninety days
    36  from the occurrence of the violation.
    37    3. Subdivisions one and  two  of  this  section  shall  not  apply  to
    38  licensed  veterinarians.  A  veterinarian  who  violates this section is
    39  subject to discipline as defined in  subarticle  three  of  article  one
    40  hundred thirty of title eight of this chapter.
    41    4.  The  moneys  collected pursuant to this article shall be deposited
    42  into the antibiotics education  fund  established  pursuant  to  section
    43  ninety-seven-j of the state finance law and be available for expenditure
    44  upon appropriation by the legislature.
    45    §  3. The state finance law is amended by adding a new section 97-j to
    46  read as follows:
    47    § 97-j. Antibiotics education fund. 1. There is hereby established  in
    48  the  custody  of the state comptroller a special fund to be known as the
    49  "antibiotics education fund".
    50    2. Such fund shall consist of all monies recovered from the assessment
    51  of any penalty authorized by article one hundred  thirty-five-A  of  the
    52  education law.
    53    3. Moneys of the fund shall be deposited to the credit of the fund and
    54  shall,  in addition to any other moneys made available for such purpose,
    55  be available to the department for the  purpose  of  antibiotics  educa-
    56  tional  programs. All payments from the antibiotics education fund shall

        A. 3493--B                          7
 
     1  be made on the audit and warrant of the state  comptroller  on  vouchers
     2  certified and submitted by the commissioner.
     3    § 4. This act shall take effect January 1, 2023.
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