BILL ANALYSIS Ó
SENATE COMMITTEE ON AGRICULTURE
Senator Cathleen Galgiani, Chair
2015 - 2016 Regular
Bill No: SB 27 Hearing Date: 4/21/15
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|Author: |Hill |
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|Version: |12/1/14 |
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|Urgency: |No |Fiscal: |Yes |
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|Consultant:|Anne Megaro |
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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,
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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 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
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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
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
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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 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 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.
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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-the-counter 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-client-patient relationship.
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
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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 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
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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
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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. 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
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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 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
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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 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
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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.
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
SB 27 (Hill) Page 12 of ?
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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