Chapter 4.5. Livestock: Use Of Antimicrobial Drugs of California Food And Agricultural Code >> Division 7. >> Chapter 4.5.
For purposes of this chapter, the following definitions
apply:
(a) "Medically important antimicrobial drug" means an
antimicrobial drug listed in Appendix A of the federal Food and Drug
Administration's Guidance for Industry #152, including critically
important, highly important, and important antimicrobial drugs, as
that appendix may be amended.
(b) "Livestock" means all animals and poultry, including aquatic
and amphibian species, that are raised, kept, or used for profit.
Livestock does not include bees or those species that are usually
kept as pets, such as dogs, cats, and pet birds.
(c) "Veterinary feed directive" has the same definition as in
Section 558.3 of Title 21 of the Code of Federal Regulations.
Beginning January 1, 2018, a medically important
antimicrobial drug shall not be administered to livestock unless
ordered by a licensed veterinarian through a prescription or
veterinary feed directive, pursuant to a veterinarian-client-patient
relationship that meets the requirements of Section 2032.1 of Title
16 of the California Code of Regulations.
(a) Beginning January 1, 2018, a medically important
antimicrobial drug may be used when, in the professional judgment of
a licensed veterinarian, the medically important antimicrobial drug
is any of the following:
(1) Necessary to treat a disease or infection.
(2) Necessary to control the spread of a disease or infection.
(3) Necessary in relation to surgery or a medical procedure.
(b) A medically important antimicrobial drug may also be used
when, in the professional judgment of a licensed veterinarian, it is
needed for prophylaxis to address an elevated risk of contraction of
a particular disease or infection.
(c) A person shall not administer a medically important
antimicrobial drug to livestock solely for purposes of promoting
weight gain or improving feed efficiency.
(d) Unless the administration is consistent with subdivision (a),
a person shall not administer a medically important antimicrobial
drug in a regular pattern.
(a) Notwithstanding Sections 14401 and 14402 of this code
and Article 15 (commencing with Section 4196) of Chapter 9 of
Division 2 of the Business and Professions Code, medically important
antimicrobial drugs may be sold by retailers licensed pursuant to
Article 5 (commencing with Section 14321) of Chapter 4 of Division 7
with a prescription or veterinary feed directive from a licensed
veterinarian.
(b) This section shall not be construed to invalidate the
requirement to obtain a prescription or veterinary feed directive to
administer a medically important antimicrobial drug as required by
Section 14401.
(c) The department may promulgate regulations to implement this
section.
(a) The department, in consultation with the Veterinary
Medical Board, the State Department of Public Health, universities,
and cooperative extensions, shall develop antimicrobial stewardship
guidelines and best management practices for veterinarians, as well
as livestock owners and their employees who are involved with
administering medically important antimicrobial drugs, on the proper
use of medically important antimicrobial drugs for disease treatment,
control, and prevention. The guidelines shall include scientifically
validated practical alternatives to the use of medically important
antimicrobial drugs, including, but not limited to, the introduction
of effective vaccines and good hygiene and management practices.
(b) The department shall consult with livestock producers,
licensed veterinarians, and any other relevant stakeholders on
ensuring livestock timely access to treatment for producers in rural
areas with limited access to veterinary care.
(c) For purposes of this section, "antimicrobial stewardship" is a
commitment to do all of the following:
(1) To use medically important antimicrobial drugs only when
necessary to treat, control, and, in some cases, prevent, disease.
(2) To select the appropriate medically important antimicrobial
drug and the appropriate dose, duration, and route of administration.
(3) To use medically important antimicrobial drugs for the
shortest duration necessary and to administer them to the fewest
animals necessary.
(a) It is the intent of the Legislature that the department
coordinate with the United States Department of Agriculture, the
federal Food and Drug Administration, and the federal Centers for
Disease Control and Prevention to implement the expanded
antimicrobial resistance surveillance efforts included in the
National Action Plan for Combating Antibiotic-Resistant Bacteria, and
that the information gathered through this effort will help lead to
a better understanding of the links between antimicrobial use
patterns in livestock and the development of antimicrobial resistant
bacterial infections.
(b) (1) The department shall gather information on medically
important antimicrobial drug sales and usage, as well as
antimicrobial resistant bacteria and livestock management practice
data. Monitoring efforts shall not be duplicative of the National
Animal Health Monitoring System and the National Antimicrobial
Resistance Monitoring System, and, to the extent feasible, the
department shall coordinate with the United States Department of
Agriculture, the federal Centers for Disease Control and Prevention,
and the federal Food and Drug Administration in the development of
these efforts.
(2) In coordinating with the National Animal Health Monitoring
System and the National Antimicrobial Resistant Monitoring System,
the department shall gather representative samples from all of the
following:
(A) California's major livestock segments.
(B) Regions with considerable livestock production.
(C) Representative segments of the food production chain.
(c) The department shall work with willing participants to gather
samples and shall consult with, and conduct outreach to, livestock
producers, licensed veterinarians, and any other relevant
stakeholders on the implementation of the monitoring efforts.
Participation in this effort shall be done in a manner that does not
breach veterinary-client-patient confidentiality laws.
(d) (1) The department shall report to the Legislature by January
1, 2019, the results of its outreach activities and monitoring
efforts. The department shall advise the Legislature as to whether or
not participation is sufficient to provide statistically relevant
data. The report shall be submitted in compliance with Section 9795
of the Government Code.
(2) This subdivision is inoperative on January 1, 2023, pursuant
to Section 10231.5 of the Government Code.
(e) The department shall seek funds from federal, state, and other
sources to implement this section.
(f) The department may promulgate regulations to implement this
section.
The department has the authority to request and receive
copies of veterinary feed directives from the livestock owner,
veterinarian, or distributor to fully implement the provisions of
this chapter.
Notwithstanding the California Public Records Act (Chapter
3.5 (commencing with Section 6250) of Division 7 of Title 1 of the
Government Code), any information provided pursuant to this chapter
and Section 14902.5, if that section is added by Senate Bill 770 of
the 2015-16 Regular Session of the Legislature, shall be held
confidential, and shall not be disclosed to any person or
governmental agency, other than the department or the Veterinary
Medical Board, for the purposes of enforcing the Veterinary Medicine
Practice Act (Chapter 11 (commencing with Section 4800) of Division 2
of the Business and Professions Code), unless the data is aggregated
to prevent the identification of an individual farm or business.
Information may be shared with federal agencies so long as it is
protected by the federal Confidential Information Protection and
Statistical Efficiency Act of 2002 (Public Law 107-347).
(a) A person who violates this chapter shall be liable for a
civil penalty of not more than two hundred and fifty dollars ($250)
for each day a violation occurs.
(b) (1) For a second or subsequent violation, a person who
violates this chapter shall be punishable by an administrative fine,
levied by the secretary, in the amount of five hundred dollars ($500)
for each day a violation occurs.
(2) In addition to the administrative fine, the violator shall
attend an educational program on the judicious use of medically
important antimicrobial drugs that has been approved by the
secretary. The violator shall successfully complete the program and
provide proof to the secretary within 90 days from the occurrence of
the violation.
(c) Subdivisions (a) and (b) do not apply to licensed
veterinarians. If the Veterinary Medical Board determines that a
veterinarian is in violation of the Veterinary Medicine Practice Act
(Chapter 11 (commencing with Section 4800) of Division 2 of the
Business and Professions Code), the veterinarian may be subject to
disciplinary sanctions pursuant to the act.
(d) The moneys collected pursuant to this article shall be
deposited into the Department of Food and Agriculture Fund and shall
be available for expenditure upon appropriation by the Legislature.