BILL ANALYSIS Ó
SB 27
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Date of Hearing: July 1, 2015
ASSEMBLY COMMITTEE ON AGRICULTURE
Henry Perea, Chair
SB
27 (Hill) - As Amended June 25, 2015
SENATE VOTE: 25-10
SUBJECT: Livestock: use of antimicrobial drugs.
SUMMARY: This bill restricts the use of medically important
antimicrobial (MIAM) drugs in livestock for specified purposes,
requires a veterinarian's prescription or feed directive for
use, and eliminates the over-the-counter availability of these
drugs; requires the California Department of Food and
Agriculture (CDFA) to develop a program to track antimicrobial
drug use in livestock and the emergence of
antimicrobial-resistant bacteria; and, requires CDFA to adopt
judicious use and antimicrobial stewardship guidelines.
Specifically, this bill:
1)Provides definitions for both "medically important
antimicrobial drug" and "livestock."
2)Prohibits, beginning January 1, 2018, the administration of a
MIAM drug unless ordered by a veterinarian, through a
prescription or feed directive, that has established a
veterinarian-client-patient relationship.
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3)Prohibits, beginning January 1, 2018, the use of a MIAM drug
except when, in the professional judgment of a licensed
veterinarian, the drug is necessary for any of the following:
a) To treat a disease or infection;
b) To control the spread of a disease or infection;
c) In relation to surgery or a medical procedure; and,
d) To prevent the transmission of a particular disease or
infection known or suspected to occur in a specific
situation.
4)Prohibits a person from administering a MIAM drug to livestock
for solely the purposes of promoting weight gain or improving
feed efficiency.
5)Prohibits a person from administering a MIAM drug in a
repeated or regular pattern unless if consistent with #3,
above.
6)Allows MIAM to be sold at a feed store, as specified, with
proof of a veterinarian order.
7)Allows CDFA to develop regulation, as specified.
8)Allows CDFA to implement programs to promote the judicious use
of MIAM drugs in livestock. Programs may include, but are not
limited to, antimicrobial stewardship guidelines, as
specified.
9)Requires CDFA to work with specified stakeholders on ensuring
that livestock has timely access to treatment in rural areas.
10)Defines "antimicrobial stewardship" as a commitment to:
a) Use MIAM drugs only when necessary to treat, control,
and, in some cases, prevent disease;
b) Choose and administer the appropriate MIAM drug
correctly each time; and,
c) Use MIAM drugs for the shortest duration necessary and
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administered to the fewest animals necessary.
11)Requires CDFA, in consultation with the Veterinary Medical
Board (VMB), to sponsor projects or collaborate with specified
entities to:
a) Promote and develop training material to develop
stewardship practices; and,
b) Disseminate scientifically validated practical
alternatives that may reduce antimicrobial use.
12)Requires CDFA to develop a monitoring program that gathers
information on sales, usage, resistance, and management
practice data. Requires CDFA to coordinate with federal
monitoring systems and ensure that the monitoring program is
compatible and not duplicative of the federal programs.
13)Allows CDFA to request information from livestock owners,
veterinarian and distributors related to feed directives and
prescriptions. Requires participation in information requests
be done in a way that does not breach veterinary patient
confidentiality law.
14)Requires CDFA to seek federal, state or other funds to
implement the monitoring program.
15)Requires CDFA to consider how best to gather representative
samples from:
a) California's major livestock segments;
b) Regions with considerable livestock production; and,
c) Representative segments of the food production chain.
16)Requires CDFA's monitoring program to work with willing
participants and allows CDFA to consult with specified stake
holders in implementing the monitoring program.
17)Requires that any released information gathered by the
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monitoring program is aggregated to prevent the identification
of individual farms or businesses. Allows an exemption for
the purpose of enforcing the Veterinary Medicine Practice Act.
18)Provides a $250.00 per day civil fine for a violation of this
law. Provides for a $500 per day administrative fine for
subsequent violations that take place with a year of a civil
fine, in addition to attending an education program on the
judicious use of antimicrobials, as specified.
a) Allows the VMB to take action against a veterinarian in
violation of this law.
19)Requires, starting January 1, 2018, veterinarians applying
for licensure must complete an approved course on the
judicious use of antimicrobials every four years, as a part of
the continuing education requirement.
EXISTING LAW:
Federal law:
1) Requires the Food and Drug Administration (FDA) to
protect public health by ensuring the safety,
effectiveness, quality, and security of human and
veterinary drugs. Within FDA, the Center for Veterinary
Medicine regulates the manufacture and distribution of
drugs that will be administered to animals and regulates
medicated feed.
2) Establishes the Animal Drug Availability Act in 1996 to
create a new regulatory category for certain animal drugs
used in animal feed. Previously, drugs were only available
through two means: over-the-counter (OTC) and by
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prescription. As new drugs (antimicrobials) were
developed, FDA recognized the need for these drugs to be
administered through feed.
3) Creates the Veterinary Feed Directive (VFD) to allow
more flexibility for new animal drugs to be administered
through medicated feed but done so under the supervision of
a licensed veterinarian.
State law:
1) Requires CDFA, through the Livestock Drug Program, to
regulate the manufacture, sale, registration, and use of
livestock drugs, except when the livestock drug is sold by
prescription only, used exclusively by a veterinarian, or
used only under a veterinarian's direction. CDFA is
required to register OTC livestock drugs and regulate their
use for safety and efficacy.
2) Requires the California State Board of Pharmacy to
enforce laws and regulations regarding prescription drugs
and drugs used exclusively by veterinarians.
FISCAL EFFECT: Unknown. This bill has been keyed fiscal by
Legislative Counsel.
COMMENTS: Antimicrobial drugs have been widely used in human
medicine since the 1940s. Antimicrobial drugs have significant
health benefits in both human and animal medicine, and are
important and valuable tools used to treat and prevent illness
and infection. Incidences of antimicrobial resistance have been
recorded over time and, if left unchecked, pose a threat to
public health.
The Centers for Disease Control (CDC) estimates that in the
United States, more than two million people are sickened every
year with antibiotic-resistant infections, with at least 23,000
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infections resulting in death. In a recent report, CDC lists
four core actions that fight the spread of antibiotic
resistance: 1) preventing infections from occurring and
preventing resistant bacteria from spreading; 2) tracking
resistant bacteria; 3) improving the use of antibiotics; and, 4)
promoting the development of new antibiotic and new diagnostic
tests for resistant bacteria.
CDC notes that the use of antibiotics is the single most
important factor leading to antibiotic resistance around the
world. Up to 50% of all antibiotics prescribed for people are
either not needed or not optimally effective as prescribed.
Antibiotics are also used in food-producing animals for the
purpose of promoting growth, which CDC recommends phasing out.
In the past decade, FDA has worked on creating Guidance for
Industry (GFI) regarding the judicious use of MIAM drugs in food
producing animals. In three GFIs, FDA has: 1) GFI #152, compiled
a list of MIAM drugs categorized by their importance to human
health; 2) GFI #219, developed principals that determine the
appropriate or judicious use of such drugs, by limiting use to
only when necessary to maintain animal health, and with
veterinary oversight or consultation; and, 3) GFI #213 provided
recommendations as to the implementation of the guidelines. The
FDA concludes that using MIAM drugs for animal growth promotion
or feed efficiency is not a judicious use, and that veterinary
oversight or consultation is necessary when using these drugs.
In December 2013, FDA released the final draft of GFI #213. GFI
#213 contains nonbinding recommendations to industry regarding
the use of MIAM drugs in the feed and drinking water of
food-producing animals. FDA intends to work with drug companies
to help them voluntarily implement the recommendations, which
include: 1) phasing out the use of MIAM drugs in food-producing
animals for production purposes (growth promotion and feed
efficiency); and, 2) include veterinary oversight of these drugs
when used in the feed or water of food-producing animals.
In September of 2014, President Obama issued an Executive Order:
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Combating Antibiotic-Resistant Bacteria, and the National
Strategy for Combating Antibiotic-Resistant Bacteria, and in
March 2015, the White House issued the National Action Plan for
Combating Antibiotic-Resistant Bacteria (Action Plan). The
Action Plan lays out a five-year plan with five distinct goals:
1) slow the emergence of resistant bacteria; 2) strengthen
One-Health surveillance efforts; 3) advance the development and
use of rapid diagnostic tests to identify resistant bacteria; 4)
accelerate the development of new antibiotics, other treatments,
and vaccines; and, 5) improve international collaboration to
achieve these goals. For antimicrobial use in food animals
(livestock), the Action Plan seeks to implement FDA's GFIs.
USDA currently operates national laboratory systems that survey
national animal health and monitor antimicrobial resistance: the
National Animal Health Monitoring System (NAHMS) and the
National Antimicrobial Resistance Monitoring System (NARMS).
NAHMS collects and analyzes data on animal health, management,
and productivity and to conduct national studies on livestock
populations. Under federal confidentially laws, data collected
by NAHMS allows producers or livestock owners to voluntarily
provide sensitive and confidential information such as on-farm
management practices and animal health issues. USDA states that
this is vital to encourage voluntary participation and to
maintain high response rates.
NARMS was established by FDA in conjunction with CDC and USDA to
monitor trends in antimicrobial resistance from human, retail
meat, and food animal samples. The goals and objectives of
NARMS' monitoring program are to monitor trends in antimicrobial
resistance among foodborne bacteria, conduct research to better
understand the emergence and spread of resistant bacteria, and
to assist FDA in decision making for the approval of
antimicrobial drugs for animals.
The California Animal Health and Food Safety (CAHFS) Laboratory
System is the state entity responsible for providing rapid
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diagnostic testing for animal health diseases, and those
diseases that affect humans. CAHFS is part of the National
Animal Health Laboratory Network, which has been included as a
component of national surveillance efforts in President Obama's
Action Plan for combating antimicrobial resistance.
The author states the overuse and misuse of antibiotics,
especially antibiotics important in human medicine, contributes
to antibiotic resistance as a growing public health threat.
Inappropriate antibiotic use and overuse in humans drives the
development of antibiotic resistance, but there is also a
concern about antibiotic use in livestock and poultry. To
address the issues of antibiotic use in livestock and poultry,
this bill will do the following: 1) Ensure veterinary oversight
by requiring prescriptions for antibiotics administered to
livestock; 2) Prohibit the use of MIAM for growth promotion; 3)
Monitor MIAM sales, usage, resistance and management practice
data; 4) Promote the judicious use of MIAMs; and, 5) require
veterinarians to have continuing education on the judicious use
of MIAMs. This bill is a significant step forward in overseeing
the use of MIAMs.
The California Veterinary Medical Association (CVMA) has a
support if amended position. CVMA has expressed strong support
for this bill especially placing the use of MIAM under
Veterinary oversight, via prescription and VFDs. CVMAs main
concern in this bill is a potential "double jeopardy" for
veterinarians due to the fines for violations in this
legislation. Veterinarians would also be penalized under the
VMB, which can include fines, probation and revocation of
licenses. CVMA requested removing this "double jeopardy" for
veterinarians and leaving disciplinary measures with in the VMB.
The Humane Society Veterinary Medical Association (HSVMA) has a
support with amendments position. HSVMA states this bill has
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the potential to start California on the path to lessen
antimicrobial resistance caused by the overuse of MIAMs in
animal agriculture. HSVMA has suggested the following
amendments:
1) Strengthening reporting requirements to CDFA on VFD
and prescription use, and defining VFD or reference the
definition in GFI's #209 and #213.
2) More specific language related to the continued sale
of MIAMs at retail locations under this bill.
3) Changes to the antimicrobial stewardship program to
add focus on lessening the use of MAIM, "allow" instead
of "require" CDFA to consult with various groups and add
a public health organization to the list of organizations
to be consulted with for the program.
4) Tiering the fines for violations of this bill based
on number of animals and the volume of MIAMs involved in
the violation.
Opponents, many of which are opposed unless amended, state this
bill does not go far enough to restrict the use of antimicrobial
drugs for preventative or routine uses in livestock. Opponents
point out antibiotic-resistant infections can result in longer
illnesses, more hospitalizations, antibiotics with greater
side-effects, and even death when treatments fail. Resistant
infections are estimated to cost the U.S. up to $61 billion
annually in additional health care costs and lost productivity.
Furthermore, about 70% of all medically important antibiotics
sold in the US are used in livestock, where much of the use is
to accelerate animal growth and to offset risks created by the
crowded and stressful conditions at many livestock and poultry
facilities. Medical, veterinary, and scientific groups have
called for an end to the misuse and overuse of antibiotics in
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livestock to help combat the rise of antibiotic resistance.
Opponents state the bill would stop the routine use of MIAMs in
livestock that are used for growth promotion, but does not stop
the use of the same MIAMs to prevent disease, which are made
worse by crowded, stressful and unsanitary conditions. Many
MAIMs have overlapping approved use of growth promotion and
disease prevention; opponents state this bill would allow the
continued use of growth promotion under the allowed disease
prevention use. Opponents have mentioned the most effective way
to lower MIAM use is to prohibit all antibiotic use in livestock
production except for the treatment of sick animals.
The committee may which to consider the following technical
amendments for conforming purposes:
1) On page six, line 21, before the word veterinarian insert
the word licensed.
2) On page eight, line 16, strike the word animal , and replace
with livestock.
REGISTERED SUPPORT / OPPOSITION:
Support
California State Parent Teacher Association
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Opposition
None on file.
Support if amended
California Medical Veterinary Association
Humane Society Veterinary Medical Association
Opposed unless amended
California League of Conservation Voters
California Public Health Association - North
CALPIRG (updated 6/26, 2015)
Center for Food Safety (updated 6/26, 2015)
Consumers Union
Dignity Health
Environmental Working Group
Food & Water Watch (updated 6/26, 2015)
Food Chain Workers Alliance
Health Care Without Harm
Natural Resources Defense Council (updated 6/26, 2015)
Physicians for Social Responsibility, San Francisco Bay Area
Chapter
Prevention Institute
Roots of Change
Analysis Prepared by: Victor Francovich / AGRI. / (916)
319-2084
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