BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | SB 27|
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THIRD READING
Bill No: SB 27
Author: Hill (D)
Amdended: 6/1/15
Vote: 21
SENATE AGRICULTURE COMMITTEE: 3-0, 4/21/15
AYES: Galgiani, Pan, Wolk
NO VOTE RECORDED: Cannella, Berryhill
SENATE APPROPRIATIONS COMMITTEE: 5-2, 5/28/15
AYES: Lara, Beall, Hill, Leyva, Mendoza
NOES: Bates, Nielsen
SUBJECT: Livestock: use of antimicrobials drugs
SOURCE: Author
DIGEST: This bill restricts the use of medically important
antimicrobial 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 should funds be made available;
and requires CDFA to adopt judicious use regulations and
antimicrobial stewardship guidelines.
ANALYSIS:
Existing federal law:
1)Requires the Food and Drug Administration (FDA) to protect
public health by assuring the safety, effectiveness, quality,
and security of human and veterinary drugs. Within FDA, the
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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 prescription. As new
drugs (antimicrobials) were developed, FDA recognized the need
for these drugs to be administered through feed. However, FDA
wanted to establish greater control and safety measures than
were currently available under OTC status since some of these
drugs could contribute to drug toxicity and antimicrobial
resistance or have other unintended outcomes. Therefore, the
Veterinary Feed Directive (VFD) was created to allow more
flexibility for new animal drugs to be administered through
medicated feed but done so under the supervision of a licensed
veterinarian (78 Federal Register 75517, December 12, 2013).
Existing 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
(Food and Agricultural Code §14200 et seq.).
2)Requires the California State Board of Pharmacy to enforce
laws and regulations regarding prescription drugs and drugs
used exclusively by veterinarians (Business and Professions
Code § 4000 et seq.).
This bill:
1)Provides definitions for both "medically important
antimicrobial drug" and "livestock."
2)Prohibits, beginning January 1, 2017, the administration of a
medically important antimicrobial 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, 2017, the use of a medically
important antimicrobial drug except when, in the professional
judgement of a licensed veterinarian, the drug is necessary
for any of the following:
a) To treat or control the spread of a disease or
infection.
b) In relation to surgery or a medical procedure.
c) To prevent the transmission of a particular disease or
infection known to occur in a specific situation.
4)Prohibits a person from administering a medically important
antimicrobial drug in a repeated or regular pattern unless if
consistent with #3, above.
5)Prohibits a person from administering a medically important
antimicrobial drug to livestock for the purposes of promoting
weight gain or improving feed efficiency.
6)Requires CDFA, should funds be made available, to develop a
program or participate in an initiative to track the use of
medically important antimicrobial drugs in livestock as well
as antimicrobial-resistant bacteria and patterns of emerging
resistance.
7)Requires CDFA to adopt regulations to promote the judicious
use of medically important antimicrobial drugs in livestock.
Regulations shall include antimicrobial stewardship guidelines
that include rules on the proper use of medically important
antimicrobial drugs for disease prevention.
8)Defines "antimicrobial stewardship" as a commitment to:
a) Use medically important antimicrobial drugs only when
necessary to treat, control, and, in some cases, prevent
disease.
b) Choose and administer the appropriate medically
important antimicrobial drug correctly each time.
c) Use medically important antimicrobial drugs for the
shortest duration necessary and administered to the fewest
animals necessary.
Background
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Antimicrobial drugs were first developed in 1928 and became
widely used in human medicine in the 1940s. These new drugs
quickly proved to have significant health benefits in both human
and animal medicine and to this day are extremely valuable tools
used to treat and prevent illness and infection. However,
incidences of antimicrobial resistance have been recorded over
time and, if not addressed, pose a serious threat to public
health.
Antimicrobial resistance may develop for several reasons. One of
the most widely accepted contributors to antimicrobial
resistance is the misuse of antimicrobial drugs. When bacteria
are exposed to an antimicrobial drug, it provides the
opportunity for "survival of the fittest" where only the
strongest, most immune bacteria survive. These surviving,
antimicrobial-resistant bacteria then multiply to form new
colonies of resistant bacteria that may spread and infect other
individuals. For this reason, it is important to use
antimicrobial drugs judiciously in both human and animal
medicine as one method to mitigate resistance.
The Centers for Disease Control and Prevention (CDC) recently
issued a report titled Antibiotic Resistance Threats in the
United States, 2013. The 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 infections
resulting in death. In its report, the 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 antibiotics and new diagnostic tests for
resistant bacteria.
The 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 the CDC recommends phasing
out. The US Food and Drug Administration (FDA) has developed
guidances (described below) to promote judicious use of
antimicrobials that would prohibit their use for improved feed
efficiency or increased weight gain. According to the FDA's
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annual report on antimicrobial sales for animal use, 97% of
medically important antimicrobial drugs are sold OTC and not
through a veterinarian's prescription or feed directive. The
FDA guidances will address this issue and others, as described
in further detail below.
In December 2013, the FDA released the final draft of the
Guidance for Industry #213 (GFI #213), which contains nonbinding
recommendations regarding the use of medically important
antimicrobial drugs in the feed and drinking water of
food-producing animals. These recommendations include: 1)
phasing out the use of medically important antimicrobial drugs
in food-producing animals for production purposes (growth
promotion and feed efficiency) and 2) veterinary oversight of
these drugs when used in the feed or water of food-producing
animals.
The FDA's GFI #213 would change the status of antimicrobial
drugs administered in feed from OTC to VFD. Due to this change,
the FDA recognizes that current VFD regulations must be revised
and streamlined to minimize the impact on veterinarians, the
animal feed industry, and producers. These revisions are
believed to be critically important and are scheduled to be
completed before the three-year implementation timeline for GFI
#213.
On September 18, 2014, President Obama issued Executive Order
13676: Combating Antibiotic-Resistant Bacteria, which states
that this is an issue of national security and that "the Federal
Government will work domestically and internationally to detect,
prevent, and control illness and death related to
antibiotic-resistant infections by implementing measures that
reduce the emergence and spread of antibiotic-resistant bacteria
and help ensure the continued availability of effective
therapeutics for the treatment of bacterial infections." Later
that same month, the White House issued 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
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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 guidances for industry, described later
in this analysis.
The United States Department of Agriculture (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 was created in 1983
to collect and analyze data on animal health, management, and
productivity and to conduct national studies on livestock
populations. NAHMS is recognized as a statistical unit under the
Confidential Information Protection and Statistical Efficiency
Act (CIPSEA), which 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 in 1996 by the FDA in conjunction with the
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 the FDA in decision making for
the approval of antimicrobial drugs for animals.
The California Animal Health and Food Safety (CAHFS) Laboratory
System, created as a partnership between CDFA and the UC Davis
School of Veterinary Medicine, is the state entity responsible
for providing rapid diagnostic testing for animal health
diseases, and those diseases that affect humans. Most recently,
CAHFS has been involved in detecting avian influenza in both
commercial and backyard poultry but also conducts testing on any
animal brought to the lab with other concerns such as poisoning,
salmonella or other bacterial infections, rabies, and other
serious health issues for both livestock and pets. 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.
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Comments
Governor's Veto. Governor Brown vetoed a previous version of
this bill in 2014 (SB 835, Hill). In his veto message, Governor
Brown stated that "more needs to be done to understand and
reduce our reliance on antibiotics. To that end, I am directing
the Department of Food and Agriculture to work with the
Legislature to find new and effective ways to reduce the
unnecessary antibiotics used for livestock and poultry."
Work-in-progress: The author and many of the stakeholder groups
are aware that this bill is a working draft and does not
represent the final language or all of the issues involved with
limiting antimicrobial use in livestock. Several stakeholder
groups have expressed interest in continuing to work with the
author, and although many have chosen not to provide position
letters at this point, the author has received a letter stating
this intent from the California Veterinary Medical Association.
Veterinarian-client-patient relationship. The California Code of
Regulations (16 CCR § 2032.1) requires a veterinarian to
establish a veterinarian-client-patient relationship before
administering, prescribing, dispensing, or furnishing a drug or
medicine. This relationship is established when the
veterinarian has sufficient knowledge of the animal through an
examination or by medically appropriate and timely visits to the
premises where the animal is housed. Additionally, a
veterinarian shall not prescribe a drug for longer than one-year
duration.
Preventative and routine use. There is argument as to whether
antimicrobial drugs are being used judiciously when administered
to animals for the purpose of disease prevention. The concern
relates to the use of antimicrobial drugs when a disease is not
clinically present and which could provide the opportunity for
the continual, prolonged, or routine use of antimicrobial drugs
in food animals.
However, the California Veterinary Medical Association is
concerned that if antimicrobial use is restricted then
veterinarians would be prevented from "making the best medical
decisions for the health and welfare of their patients. There
are many instances where it is important to administer
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antibiotics prophylactically, such as to prevent the active
spread of 'silent killer' diseases such as Chlamydophila abortus
in sheep, particularly when there is no test available to
determine which sheep are the carriers of the disease.
Veterinarians must have the flexibility to provide scientific
and medically appropriate treatment for animals under their
care."
Tracking. The creation of an antimicrobial use and resistance
tracking program has expressed support from the Natural
Resources Defense Council, which believes that more data should
be collected and available given the amount of antimicrobials
used in feed and water. Conversely, a tracking program is an
expressed concern of many of the agricultural stakeholders as
well as the California Veterinary Medical Association given that
the implementation of such a program is believed to be difficult
and expensive, and that many details and responsibilities not
specified in the current bill. For instance, it is unclear
which entity would be required to report antimicrobial use: the
producer, veterinarian, slaughterhouse, feed mill, or other
entity. Another great concern of these groups is
confidentiality of this information, as previously described
with the NAHMS laboratory. Furthermore, the federal government
is currently proposing an expanded nationwide antimicrobial use
and resistance surveillance program, as outlined in the USDA
Antimicrobial Resistance Plan published in June 2014 and in
President Obama's Action Plan.
Over-the-counter accessibility. This bill would eliminate the
OTC availability of all medically important antimicrobial drugs
administered to livestock. However, there are concerns from the
livestock industry that this change will limit their ability to
obtain necessary medication for their livestock. In some cases,
the ranch is located in a remote area where a veterinarian is
not readily available. Furthermore, if the antimicrobial is no
longer available OTC at the local farm store and given that not
all pharmacies carry livestock drugs, there is concern that the
antimicrobial will not be available for purchase in a timely
manner. However, the California Veterinary Medical Association
believes that "there should be veterinary supervision of
antimicrobial drugs in animals, since their improper use has
serious implications."
Antimicrobial stewardship. Several livestock industries have
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developed best management practices/quality assurance/herd
improvement programs that address animal welfare and food safety
issues. The Beef Quality Assurance program includes guidelines
on the judicious use of antimicrobial drugs. Additionally, the
American Veterinary Medical Association provides guidelines for
the judicious use of antimicrobial drugs in livestock. Should
this bill become law, CDFA may draw from these existing programs
to develop a statewide guidance program; however, the issue of
developing antimicrobial stewardship guidelines has not been
thoroughly discussed within the context of this bill.
Continuing education. The California Veterinary Medical
Association has proposed amendments that would make a course on
the judicious use of antimicrobial drugs a required component of
continuing education courses for veterinary license renewal.
Currently, veterinarians must complete 36 hours of continuing
education credits every two years as a requirement of license
renewal. These classes allow veterinarians to stay current on
new therapies, studies, treatments, illnesses, technologies, and
other related issues; therefore if this amendment were adopted,
veterinarians would be required to attend an approved course on
the judicious use of antimicrobial drugs at least once every two
years (Business and Professions Code § 4846.5).
FISCAL EFFECT: Appropriation: No Fiscal
Com.:YesLocal: Yes
According to the Senate Appropriations Committee, there are
"unknown costs to CDFA to develop a program to track the use of
antimicrobial drugs in livestock. Cost would be dependent on the
scope of the program developed and the extent to which funding
is made available (special fund)."
SUPPORT: (Verified5/29/15)
None received
OPPOSITION: (Verified5/29/15)
California League of Conservation Voters
California Public Health Association - North
CALPIRG
Center for Food Safety
Consumers Union
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Dignity Health
Environmental Working Group
Food & Water Watch
Food Chain Workers Alliance
Health Care Without Harm
Humane Society Veterinary Medical Association
Natural Resources Defense Council
Physicians for Social Responsibility, San Francisco Bay Area
Chapter
Prevention Institute
Roots of Change
ARGUMENTS IN SUPPORT: According to the author, "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. Based on the best information available from the
federal Food and Drug Administration (FDA), it's estimated that
at least 70 percent of all medically important antibiotics are
sold for use in livestock and poultry. [?] The data available
on antibiotic use in livestock and poultry is in itself a
problem; in large part, many consider the data to be
insufficient since the only data collected is sales data. More,
and better data, needs to be collected to properly address this
issue. While there may be data gaps about antibiotic use in
livestock and poultry, we do know that under current law the
majority of medically important antibiotics may be sold for use
in livestock and poultry without veterinary oversight. [?]
Antibiotic stewardship programs are a commitment to always use
antibiotics only when they are necessary, to choose the right
antibiotics and to administer them in the right way in every
case. Antibiotic stewardship programs have been effective in
reducing inappropriate antibiotic use in humans, as well in
reducing antibiotic resistance. [?] However, there is no similar
requirement that veterinarians and livestock and poultry
producers follow antibiotic stewardship guidelines."
ARGUMENTS IN OPPOSITION: All of the organizations listed on
this analysis under "Opposition", except for the Consumers
Union, are in fact "Opposed unless amended." These organizations
have the same concern: namely, that this bill does not go far
enough to restrict the use of antimicrobial drugs for
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preventative or routine uses in livestock. These organizations
state that, "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. Growing resistance also puts complicated medical
procedures such as heart surgery, organ transplants, and
chemotherapy in jeopardy" due to reliance on effective
antibiotics. 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 livestock to help combat the rise of
antibiotic resistance."
The Consumers Union has similar concerns regarding the
preventative use of antimicrobial drugs, as well as the concern
that "the data reporting part of the bill does not require
reporting of total quantity of antibiotics used."
Prepared by:Anne Megaro / AGRI. / (916) 651-1508
6/1/15 19:33:04
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