Bill Text: NY A08335 | 2019-2020 | General Assembly | Introduced


Bill Title: Relates to protecting medically important antimicrobials for human public health.

Spectrum: Partisan Bill (Democrat 4-0)

Status: (Introduced - Dead) 2020-01-27 - enacting clause stricken [A08335 Detail]

Download: New_York-2019-A08335-Introduced.html



                STATE OF NEW YORK
        ________________________________________________________________________

                                          8335

                               2019-2020 Regular Sessions

                   IN ASSEMBLY

                                      June 14, 2019
                                       ___________

        Introduced  by M. of A. ROMEO -- read once and referred to the Committee
          on Higher Education

        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
    20  and  the  Centers  for  Disease  Control and Prevention have stated that
    21  there is a definitive link between the routine use of  medically  impor-
    22  tant  antimicrobials  on industrial farms and the crisis of antimicrobi-
    23  al-resistant infections in humans.

         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD11330-09-9

        A. 8335                             2

     1    The issue of antimicrobial misuse and overuse, whether  in  people  or
     2  animals, is a significant and urgent public health matter.
     3    It  has been estimated that seventy percent of all antimicrobials sold
     4  in the United States are for use in  food-producing  animals,  often  to
     5  compensate  for  the effects of unsanitary and overcrowded conditions on
     6  farms.
     7    Many of the antimicrobials  provided  to  food-producing  animals  are
     8  identical to, or from the same class as, drugs used in human medicine to
     9  treat  serious conditions (i.e., medically important drugs). Thus, anti-
    10  microbial-resistant bacteria that emerge and spread from  food-producing
    11  animals  in farm settings to infect humans can be very dangerous because
    12  the antibiotics usually used to treat the infections in  humans  may  no
    13  longer be effective against them.
    14    The  legislature  further  finds  that,  as  with any use of medically
    15  important antimicrobials in animals, such use must be closely supervised
    16  by a New York state licensed veterinarian or those veterinarians author-
    17  ized to practice within the state. Moreover, that  it  is  the  licensed
    18  veterinarian who must ensure that the use of medically important antimi-
    19  crobials is appropriate and necessary.
    20    The legislature therefore intends to place appropriate restrictions on
    21  the  misuse  and  overuse of medically important antimicrobials in food-
    22  producing animals by ensuring that veterinarians have the clear authori-
    23  ty to control the use of medically important antimicrobials in food-pro-
    24  ducing animals in New York state and that their practices are  following
    25  the best scientific evidence.
    26    The  purpose of this act is to protect public health by preserving the
    27  effectiveness of medically important antimicrobials now and  for  future
    28  generations  by eliminating the use of those medicines in food-producing
    29  animals for disease prevention, resulting in a reduction in the rise and
    30  spread of antimicrobial-resistant bacteria  and  antimicrobial-resistant
    31  infections in humans.
    32    §  2.  The  education  law is amended by adding a new article 135-A to
    33  read as follows:
    34                                ARTICLE 135-A
    35                   COMBATING ANTIMICROBIAL RESISTANCE ACT
    36  Section 6720. Short title.
    37          6721. Definitions.
    38          6722. Prohibition of certain antimicrobial administration.
    39          6723. Authorization of certain antimicrobial administration.
    40          6724. Annual reports.
    41          6725. Antimicrobial stewardship guidelines.
    42          6726. Implementation.
    43          6727. Authority to receive Veterinary Feed Directives.
    44          6728. Violations.
    45    § 6720. Short title. This act shall be known and may be cited  as  the
    46  "combating antimicrobial resistance act of 2019."
    47    § 6721. Definitions. As used in this section:
    48    1.  "Antimicrobial" means any substance of natural, semi-synthetic, or
    49  synthetic origin that at in vivo concentrations kills  or  inhibits  the
    50  growth of microorganisms by interacting with a specific target. The term
    51  antimicrobial  is a collective for antiviral, antibacterial, antifungal,
    52  antiparasitic, and antiprotozoal agents.
    53    2. "Antimicrobial  class"  means  antimicrobial  agents  with  related
    54  molecular  structures,  often  with  a similar mode of action because of
    55  interaction with a similar target and thus subject to  a  similar  mech-
    56  anism of resistance.

        A. 8335                             3

     1    3. "Antimicrobial resistance (AMR)" means the ability of a microorgan-
     2  ism  to  multiply or persist in the presence of an increased level of an
     3  antimicrobial relative  to  the  susceptible  counterpart  of  the  same
     4  species.
     5    4. "Disease control" means administration of antimicrobial agents to a
     6  group of animals containing sick and healthy individuals (presumed to be
     7  infected),  to  minimize or resolve clinical signs of infectious disease
     8  and to prevent further spread of the disease.
     9    5. "Disease prevention" means administration of  antimicrobial  agents
    10  to  an  individual or a group of animals at risk of acquiring a specific
    11  infection or in a specific situation where infectious disease is  likely
    12  to occur if the antimicrobial agent is not administered.
    13    6. "Disease treatment" means administration of antimicrobial agents to
    14  an  individual  or group of animals showing clinical signs of infectious
    15  disease or that test positive for a disease.
    16    7. "Food-producing animal" means:
    17    (a) All cattle, swine, or poultry, regardless of whether the  specific
    18  animal  is  raised  for the purpose of producing food for human consump-
    19  tion; or
    20    (b) Any animal of a  type  that  the  department  of  agriculture  and
    21  markets  identifies  by rule as livestock typically used to produce food
    22  for human consumption, including aquatic and amphibian species.
    23    8. "Livestock producer" means a person raising a food-producing animal
    24  for commercial purposes.
    25    9. "Medically important antimicrobial" means a drug that  is  composed
    26  in whole or in part of:
    27    (a)  A  form  of  the  antibiotic  classes of penicillin, tetracyline,
    28  macrolide, lincosamide, streptogramin, aminoglycoside,  sulfonamide,  or
    29  cephalosporin; or
    30    (b)  A  drug  from an antimicrobial class that is categorized as crit-
    31  ically important, highly important, or important  in  the  World  Health
    32  Organization list of Critically Important Antimicrobials for Human Medi-
    33  cine  (5th  Revision, 2016), or a subsequent revision or successor docu-
    34  ment issued by the World Health Organization that is recognized by  rule
    35  by the department of health.
    36    10.  "Veterinary Feed Directive" has the same definition as in section
    37  558.3 of title 21 of the code of federal regulations.
    38    § 6722. Prohibition of certain antimicrobial administration.    Begin-
    39  ning  January first, two thousand twenty, medically important antimicro-
    40  bials shall not  be  administered  to  a  food-producing  animal  unless
    41  ordered  by  a  licensed veterinarian who has visited the farm operation
    42  within the previous six months, through  a  prescription  or  Veterinary
    43  Feed  Directive,  pursuant to a veterinarian-client-patient relationship
    44  that meets the requirements as defined by the New York state  office  of
    45  professions.
    46    §  6723.  Authorization  of  certain  antimicrobial administration. 1.
    47  Beginning January first, two thousand twenty, a livestock  producer  may
    48  provide  a  medically important antimicrobial to a food-producing animal
    49  only if a licensed veterinarian, in the exercise of  professional  judg-
    50  ment,  determines  that the provision of the medically important antimi-
    51  crobial to the animal is necessary:
    52    (a) To control the spread of a disease or infection;
    53    (b) To treat a disease or infection; or
    54    (c) In relation to surgical or other medical procedures.

        A. 8335                             4

     1    2. Medically important antimicrobials shall not be administered by any
     2  person to food-producing animals solely for the  purposes  of  promoting
     3  weight gain, improving feed efficiency, or disease prevention.
     4    3.  A  veterinarian  who  determines that the provision of a medically
     5  important antimicrobial to a food-producing animal is  necessary  for  a
     6  purpose  described  in  this  section  shall specify an end date for the
     7  provision of the antimicrobial to the animal.
     8    4. A livestock producer may administer a medically  important  antimi-
     9  crobial to a food-producing animal only for the purpose as determined by
    10  a  licensed veterinarian under this article.  The livestock producer may
    11  provide the antimicrobial only for the duration specified by the veteri-
    12  narian.
    13    § 6724. Annual reports. 1. Veterinarians licensed to practice  in  New
    14  York state, or who are licensed in a bordering state and practice in the
    15  state,  and  who prescribe medically important antimicrobials or write a
    16  Veterinary Feed Directive for one or more sets of food-producing animals
    17  must file an annual report under this  section  in  a  form  and  manner
    18  required by the department by rule. This report will be submitted to the
    19  commissioner,  the  commissioner of health, the commissioner of agricul-
    20  ture and markets, the temporary president  of  the  senate,  the  senate
    21  minority leader, the speaker of the assembly, and the minority leader of
    22  the  assembly. If any medically important antimicrobials were prescribed
    23  to, provided to, or administered to food-producing  animals  during  the
    24  reporting  period, the annual report must contain the following informa-
    25  tion:
    26    (a) The total number of food-producing animals provided with medically
    27  important antimicrobials;
    28    (b) The name of each medically important antimicrobial provided;
    29    (c) The species of food-producing animals that were provided with each
    30  medically important antimicrobial;
    31    (d) The quantity of each medically important antimicrobial  prescribed
    32  to each species of food-producing animal;
    33    (e) The number of days that each medically important antimicrobial was
    34  intended to be provided to a food-producing animal;
    35    (f)  The  dosage  of  each  medically important antimicrobial that was
    36  intended to be provided to a food-producing animal;
    37    (g) The method for providing each medically important antimicrobial to
    38  a food-producing animal;
    39    (h) The purpose for providing each medically  important  antimicrobial
    40  to a food-producing animal; and
    41    (i)  The  disease  or  infection,  if  any,  that  was  intended to be
    42  controlled due to the provision of each medically important antimicrobi-
    43  al.
    44    2. For the purposes of  paragraph  (h)  of  subdivision  one  of  this
    45  section,  the  purpose for providing a medically important antimicrobial
    46  to a food-producing animal must be reported as:
    47    (a) Disease control; or
    48    (b) Disease treatment; or
    49    (c) Necessary for surgical or other medical procedures.
    50    3. Information reported under this section  should  be  made  publicly
    51  available  by  the department of health annually in an online searchable
    52  database of aggregated data.  Such database shall protect  the  identity
    53  of a licensed veterinarian, an individual farm or business.
    54    4.  Information  reported under this section is a public record and is
    55  not subject to exemption from public disclosure as  required  under  the
    56  New York state freedom of information law.

        A. 8335                             5

     1    5.  The  state  board of veterinary medicine, the department of health
     2  and the department of agriculture and markets will consult as  necessary
     3  to fulfill the requirements of this section.
     4    §  6725.  Antimicrobial  stewardship guidelines. 1. The state board of
     5  veterinary medicine, in consultation with the department of  agriculture
     6  and  markets,  the  department  of health, universities, and cooperative
     7  extensions, shall develop antimicrobial stewardship guidelines and  best
     8  management  practices  for  veterinarians,  livestock  owners, and their
     9  employees who are involved with the administering of medically important
    10  antimicrobials on the proper use of medically  important  antimicrobials
    11  for  disease  treatment and control. The guidelines shall include scien-
    12  tifically validated practical  alternatives  to  the  use  of  medically
    13  important  antimicrobials,  including,  but not limited to, good hygiene
    14  and management practices. The guidelines shall be reviewed  and  updated
    15  periodically, as necessary.
    16    2. The state board of veterinary medicine shall consult with livestock
    17  producers,  licensed  veterinarians,  and other relevant stakeholders on
    18  ensuring that livestock grown in rural  areas  with  limited  access  to
    19  veterinary care have timely access to treatment.
    20    3.  For the purposes of this section, "antimicrobial stewardship" is a
    21  commitment to do all of the following:
    22    (a) To use medically important microbials only when necessary to treat
    23  or control disease;
    24    (b) To select the appropriate medically important  microbial  and  the
    25  appropriate dose, duration, and route of administration; and
    26    (c)  To  use  medically important microbials for the shortest duration
    27  necessary and allowable, and to administer them to  the  fewest  animals
    28  necessary.
    29    § 6726. Implementation. 1. The state board of veterinary medicine, the
    30  department  of  health,  and  the  department of agriculture and markets
    31  shall coordinate with the United States Department of  Agriculture,  the
    32  United  States Food and Drug Administration, and the Centers for Disease
    33  Control and Prevention to implement the expanded  antimicrobial  resist-
    34  ance  surveillance  efforts  included  in  the  National Action Plan for
    35  Combating Antibiotic-Resistant Bacteria, and that the information  gath-
    36  ered through this effort will help lead to a better understanding of the
    37  links  between  antimicrobial use patterns in livestock and the develop-
    38  ment of antimicrobial-resistant bacterial infections.
    39    2. (a) The department of health, the state board of  veterinary  medi-
    40  cine,  the  department  of  agriculture  and markets, veterinarians, and
    41  livestock producers shall  gather  information  on  medically  important
    42  antimicrobial  sales and usage as well as antimicrobial-resistant bacte-
    43  ria and livestock management practice data.   Monitoring  efforts  shall
    44  not  be  duplicative  of the National Animal Health Monitoring System or
    45  the National Antimicrobial Resistance Monitoring  System,  and,  to  the
    46  extent  feasible,  will  coordinate with the United States Department of
    47  Agriculture, the Centers for Disease Control  and  Prevention,  and  the
    48  United  States  Food and Drug Administration in the development of these
    49  efforts.
    50    (b) In coordinating with the National Animal Health Monitoring  System
    51  and the National Antimicrobial Resistance Monitoring System, the depart-
    52  ment  of  health, the state board of veterinary medicine and the depart-
    53  ment of agriculture and markets shall gather representative  samples  of
    54  biological isolates from all of the following:
    55    (i) New York state's major livestock segments;
    56    (ii) regions with considerable livestock production; and

        A. 8335                             6

     1    (iii) representative segments of the food production chain.
     2    (c)  The  department of health, the state board of veterinary medicine
     3  and the department of agriculture and markets shall report to the legis-
     4  lature by January first, two thousand twenty-one, the results  of  their
     5  outreach activities and monitoring efforts.
     6    §  6727.  Authority to receive Veterinary Feed Directives. The depart-
     7  ment of agriculture and markets has the authority to request and receive
     8  copies of all Veterinary Feed Directives issued in the state from veter-
     9  inarians, livestock owners, feed mills, or distributors to fully  imple-
    10  ment the provisions of this article.
    11    §  6728.  Violations.  1. A person or entity who violates this article
    12  shall be liable for a civil penalty of not more  than  two  hundred  and
    13  fifty dollars per farm operation for each day a violation occurs.
    14    2.  (a)  For  a second or subsequent violation, a person or entity who
    15  violates this article shall be punishable by an administrative  fine  in
    16  the  amount  of  five  hundred dollars per farm operation for each day a
    17  violation occurs.
    18    (b) In addition to the administrative fine, the violator shall  attend
    19  an  educational  program  to  be  jointly developed by the department of
    20  health and the state board of veterinary medicine on the  judicious  use
    21  of  medically  important antimicrobials. The violator shall successfully
    22  complete the program and provide proof to the board within  ninety  days
    23  from the occurrence of the violation.
    24    3.  Subdivisions  one  and  two  of  this  section  shall not apply to
    25  licensed veterinarians. A veterinarian  who  violates  this  section  is
    26  subject  to  discipline  as  defined  in subarticle three of article one
    27  hundred thirty of title eight of this chapter.
    28    4. The moneys collected pursuant to this article  shall  be  deposited
    29  into  the  antibiotics  education  fund  established pursuant to section
    30  ninety-seven-j of the state finance law and be available for expenditure
    31  upon appropriation by the legislature.
    32    § 3. The state finance law is amended by adding a new section 97-j  to
    33  read as follows:
    34    §  97-j. Antibiotics education fund. 1. There is hereby established in
    35  the custody of the state comptroller a special fund to be known  as  the
    36  "antibiotics education fund".
    37    2. Such fund shall consist of all monies recovered from the assessment
    38  of  any  penalty  authorized by article one hundred thirty-five-A of the
    39  education law.
    40    3. Moneys of the fund shall be deposited to the credit of the fund and
    41  shall, in addition to any other moneys made available for such  purpose,
    42  be  available  to  the  department for the purpose of antibiotics educa-
    43  tional programs. All payments from the antibiotics education fund  shall
    44  be  made  on  the audit and warrant of the state comptroller on vouchers
    45  certified and submitted by the commissioner.
    46    § 4. This act shall take effect January 1, 2020.
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