SENATE COMMITTEE ON AGRICULTURE
Senator Cathleen Galgiani, Chair
2015 - 2016 Regular
Bill No:
Author:
Version:
Urgency:
Consultant:
SB 27
Hill
12/1/14
No
Anne Megaro
Hearing Date: 4/21/15
Fiscal:
Yes
Subject: Livestock: use of antibiotics
SUMMARY:
This bill would restrict the use of medically important antimicrobial drugs in
livestock for specified purposes and require a veterinarian’s prescription; require
the California Department of Food and Agriculture (CDFA) to develop a program
to track antimicrobial use in livestock and the emergence of antibiotic-resistant
bacteria; and require CDFA to adopt judicious use regulations and antibiotic
stewardship guidelines. This bill would also create a new crime. Violations of the
provisions would be a misdemeanor punishable by a $1,000 fine and/or six months
imprisonment in a county jail.
BACKGROUND AND EXISTING LAW:
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
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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 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
over-the-counter 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.
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 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
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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 (melamine), 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.
Existing federal law:
The Food and Drug Administration is responsible for protecting public health by
assuring 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.
The Animal Drug Availability Act enacted in 1996 created 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
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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).
As concerns over antimicrobial resistance grew, the FDA created guidelines for
industry regarding the judicious use of medically important antimicrobial drugs. 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
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.
Existing state law:
CDFA, through the Livestock Drug Program, is also responsible for regulating 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 over-thecounter livestock drugs and regulate their use for safety and efficacy (Food and
Agricultural Code §14200 et seq.).
The California State Board of Pharmacy is responsible for licensing, regulating and
enforcing laws and regulations regarding prescription drugs and drugs used
exclusively by veterinarians (Business and Professions Code § 4000 et seq.).
PROPOSED LAW:
This bill:
1. Provides definitions for both “medically important antimicrobial drug” and
“livestock.”
2. Prohibits the administration of a medically important antimicrobial drug
unless prescribed by a veterinarian that has established a veterinarian-clientpatient relationship.
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3. Prohibits the use of a medically important antimicrobial drug for the sole
purpose of increasing weight gain or improving feed efficiency.
4. Requires CDFA to develop a program to track the use of medically
important antimicrobial drugs in livestock as well as antibiotic-resistant
bacteria and patterns of emerging resistance.
5. Requires the new tracking program to report the following:
a. Type of drug used.
b. Number of livestock on which the drug was used.
c. Livestock species.
d. Duration of administration of the drug.
e. Purpose for which the drug was administered.
6. Requires CDFA, until March 1, 2020, to submit an annual report to the
legislature that summarizes the data from the tracking program.
7. Requires CDFA to adopt regulations to promote the judicious use of
medically important antimicrobial drugs in livestock. Regulations shall
include antibiotic stewardship guidelines that include rules on the proper use
of medically important antimicrobial drugs for disease prevention.
8. Defines “antibiotic stewardship” as a commitment to: a) use medically
important antimicrobial drugs only when necessary to treat and, in some
cases, prevent disease and b) to choose and administer the appropriate
medically important antimicrobial drug correctly each time.
9. Creates a new crime by making a violation of this chapter a misdemeanor
punishable by up to six months in county jail and/or a fine not exceeding
$1,000.
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
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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 with the position of “oppose unless
amended” 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.”
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.”
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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. It is the committee’s
understanding that, although conversations and negotiations have been taking place
since January, this bill is awaiting direction from the governor’s office before
amendments will be adopted. These stakeholder groups have expressed interest in
continuing to work with the author, and although many have chosen not to provide
position letters, the committee has received a letter stating this intent from the
California Veterinary Medical Association.
Definitions:
Antimicrobial vs. antibiotic: These terms tend to be used interchangeably,
however, they are not synonyms. Antibiotics are drugs that are designed to attack
bacteria; whereas, antimicrobials (which include antibiotics) encompass a larger
class of drugs that affect not just bacteria but other disease-causing
microorganisms such as fungi, protozoa, viruses, and parasites. The scope of this
bill and that of federal actions are aimed toward reducing antimicrobial resistance,
not just antibiotic resistance. These inconsistences are most noticeable between
the documents published by FDA (antimicrobial) and the President’s office
(antibiotics).
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.
Outstanding issues: The following is a brief summary of the many outstanding
issues that have yet to be resolved regarding antimicrobial use in livestock. This
list may not be comprehensive; however, it does represent the major issues of
concern.
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. According to
those opposed to this bill unless amended, SB 27 maintains a loophole that will
allow the routine use of antibiotics in animals that aren’t sick and where the use is
not medically necessary. For instance, this bill would not prevent the routine use
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of antibiotics in animals where the disease risk is elevated due to poor animal
husbandry practices. The Natural Resources Defense Council has been working on
amendments that would go farther than this bill and President Obama’s national
Action Plan to prevent the use of antibiotics for routine or preventative purposes.
Conversely, 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 United States Department of Agriculture (USDA) Antimicrobial
Resistance Plan published in June 2014 and in President Obama’s Action Plan.
Over-the-counter accessibility: This bill would require that all medically important
antimicrobial drugs administered to livestock be available through a veterinarian’s
prescription only. (It is the author’s intent that this ‘prescription’ includes VFD as
well, which will be clarified in the next version of this bill). However, there are
concerns from the cattle 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
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Medical Association believes that “there should be veterinary supervision of
antimicrobial drugs in animals, since their improper use has serious implications.”
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).
Misdemeanor charges: Existing provisions within the Veterinary Medicine
Practice Act authorize the Veterinary Medical Board to revoke or suspend a
veterinarian’s license and to assess a fine up to $5,000 for unprofessional conduct
including, but not limited to, fraud, negligence, incompetence, animal cruelty, or
conviction of a crime in regards to dangerous drugs or controlled substances
(Business and Professions Code § 4875 et seq.). According to the California
Veterinary Medical Association, the creation of a misdemeanor crime for failure to
comply with this chapter would be unduly punitive given the existing authority of
the Veterinary Medical Board as previously described.
However, this misdemeanor charge would apply to all Californians in violation of
this chapter, not just veterinarians. According to the Business and Professions
Code § 4831, any person who violates any provisions of the Veterinary Medicine
Practice Act is guilty of a misdemeanor that is punishable by a fine of $500 to
$2,000 and/or 30 days imprisonment in a county jail.
RELATED LEGISLATION:
SB 770 (Mendoza) of 2015. This bill would require the California Department of
Food and Agriculture to continue to be the primary regulatory agency responsible
for regulating medicated feed. This bill is currently on Third Reading on the
Senate Floor.
AB 49 (Mullin) of 2015. This bill would make findings and declarations regarding
antibiotic use in food-producing animals and would state the intent of the
legislature to enact legislation that would address the overuse of antibiotics in
livestock production. This bill has not yet been assigned to a committee.
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SB 835 (Hill) of 2014. This bill would have codified the Food and Drug
Administration’s Guidance for Industry #213, dated December 2013, by requiring
the secretary of the California Department of Food and Agriculture to refuse to
register a livestock drug administered in the feed or drinking water of food animals
if such drug is a medically important antimicrobial drug. Vetoed.
AB 1437 (Mullin) of 2014. This bill would have prohibited the sale of poultry or
livestock in California if a medically important antimicrobial drug had been
administered to the animal for nontherapeutic use such as growth promotion, feed
efficiency, weight gain, or disease prevention. This bill would have required
producers to maintain records and slaughter facilities to report specified
information in regards to the use of medically important antimicrobial drugs.
Hearing canceled at the request of the author; died in the Assembly Committee on
Agriculture.
SUPPORT:
None received
OPPOSE UNLESS AMENDED:
CALPIRG
California League of Conservation Voters
California Public Health Association – North
Center for Food Safety
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
OPPOSITION:
Consumers Union
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