SENATE RULES COMMITTEE
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SB 27
THIRD READING
Bill No:
Author:
Amdended:
Vote:
SB 27
Hill (D)
6/1/15
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 Center for Veterinary Medicine regulates the
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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
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
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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 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 foodproducing animals. These recommendations include: 1) phasing out the use of
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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 antibioticresistant 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 AntibioticResistant 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 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.
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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.
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
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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 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,
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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 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.:
Yes
Local: 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: (Verified 5/29/15)
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None received
OPPOSITION: (Verified 5/29/15)
California League of Conservation Voters
California Public Health Association – North
CALPIRG
Center for Food Safety
Consumers Union
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.”
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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 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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