BILL ANALYSIS Ó
SB 27
Page 1
Date of Hearing: August 19, 2015
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Jimmy Gomez, Chair
SB 27
(Hill) - As Amended August 17, 2015
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Urgency: No State Mandated Local Program: NoReimbursable: No
SUMMARY:
This bill prohibits, beginning January 1, 2018, the use of
medically important anti-microbial drugs (MIAMs) for the
treatment of livestock animals, except pursuant to a
prescription or feed directive from a licensed veterinarian and
when, in the professional judgment of a licensed veterinarian,
the MIAMs are necessary: (a) to treat a disease or infection;
(b) to control the spread of disease or infection; (c) in
relation to surgery or a medical procedure; or (d) as
prophylaxis to prevent the transmission of disease or infection
in specific situations. The bill forbids the use of MIAMs for
growth promotion and feed efficiency.
SB 27
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In order to implement and monitor compliance with the MIAM
rules, the bill requires the Department of Food and Agriculture
(DFA) to:
1)Coordinate with the federal Food and Drug Administration (FDA)
to develop a program to track antimicrobial drug sales, use,
resistance, and management practices;
2)Develop antimicrobial stewardship guidelines on good
management practices in consultation with the Veterinary
Medical Board (VMB), the Department of Public Health (DPH),
universities, and Cooperative Extensions; and
3)Conduct outreach and training, and report to the Legislature
by January 1, 2019 the results of outreach and monitoring
activities.
FISCAL EFFECT:
1)Estimated General and Special Fund costs of approximately
$864,000 in FY 2015-16 and $4.8 million in FY 2016-17 to
develop programs, stewardship guidelines, monitoring systems
and procedures, and regulations, as well as begin training,
inspections, and MIAMs use tracking. Annual GF and SF costs
of approximately $4.3 million thereafter to continue training,
inspections, and tracking. Some of these costs may be funded
from federal and local sources, and potentially offset in part
with civil fine revenue.
2)Potentially significant costs to VMB and DPH to help develop
stewardship guidelines and training materials.
SB 27
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COMMENTS:
1)Purpose. According to the author, overuse and misuse of
antibiotics in livestock animals, especially antibiotics
important in human medicine, contributes to antibiotic
resistance. To address the overuse and misuse, this bill is
intended to ensure veterinary oversight; encourage judicious
use of MIAMS and prohibit use for growth promotion and other
nontherapeutic purposes; and monitor MAIM sales, usage,
management practices, and resistance. According to the
California Veterinary Medical Association (CVMA), many
antimicrobials used in food production are currently available
at feed stores and online, without any veterinary prescription
or oversight.
2)Antibiotic Resistant Bacteria. The Centers for Disease
Control (CDC) estimates more than two million people are
infected with antibiotic-resistant bacteria in the United
States each year, with at least 23,000 of those infections
resulting in death. The CDC claims the use of antibiotics is
the single most important factor leading to antibiotic
resistance around the world. According to the World Health
Organization, antibiotics are used in greater quantities in
healthy food-producing animals than in the treatment of
disease in humans.
The FDA has issued several industry recommendations regarding
the use of MIAMs in the feed and drinking water of
food-producing animals. The recommendations contained in
Guidance for Industry #152, #213, and #219 establish lists of
antibiotics important to human health, promote judicious use
of those drugs in food production, and encourage veterinary
oversight to ensure compliance with industry best practices.
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In March 2015, President Obama issued a national action plan
on combating antibiotic-resistant bacteria. The five year
action plan articulated goals of slowing the emergence of
resistant bacteria, strengthening surveillance efforts,
advancing the development and use of rapid diagnostics to
identify resistant bacteria, accelerate development of new
antibiotics, treatments, and vaccines, and improve
collaboration among stakeholders. For antimicrobial use in
food animals, the plan seeks to implement the FDA guidance.
3)FDA Guidance Insufficient. SB 835 (Hill), statutes of 2014,
sought to codify the FDA guidance, but was vetoed by the
Governor. In his veto message, the Governor indicated most
animal producers were voluntarily complying with the FDA
guidance, but that more needed to be done study the problem
and reduce reliance on antibiotics.
4)The Prophylactic Problem. Opponents, led by Natural Resources
Defense Council (NRDC), argue SB 27 explicitly authorizes the
routine use of antibiotics on animals that are not sick
through the exception for prophylactic use to prevent disease
transmission or infection. NRDC argues prophylactic use will
allow back door use for nontherapeutic purposes, and is
precisely the low-dose use that contributes most to resistant
bacteria.
In response, the CVMA argues the prophylactic use exception
has been carefully crafted for judicious use of MIAMs, and the
bill explicitly forbids MIAM use for growth promotion and feed
efficiency. Furthermore, CVMA claims the bill requires
veterinary input and prescriptions for use of MIAMs, and
requires livestock owners to follow veterinary instructions.
SB 361 (Hill), a companion bill to this legislation, further
requires veterinarians to undertake continuing education
pertaining to the judicious use of antimicrobials.
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5)Voluntary Monitoring. SB 27 requires DFA to coordinate with
the FDA on efforts to expand surveillance of MIAM use and
resistant bacteria, relying on voluntary cooperation from
participants to gather samples. Opponents assert such a
system is insufficient to provide statistically significant or
accurate data on actual MIAM use and resistance.
Analysis Prepared by:Joel Tashjian / APPR. / (916)
319-2081