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.
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.
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.