BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | SB 27|
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UNFINISHED BUSINESS
Bill No: SB 27
Author: Hill (D)
Amended: 9/10/15
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
SENATE FLOOR: 25-10, 6/2/15
AYES: Beall, Berryhill, Block, Cannella, Galgiani, Hall,
Hancock, Hernandez, Hertzberg, Hill, Hueso, Jackson, Lara,
Leno, Leyva, Liu, McGuire, Mendoza, Mitchell, Monning, Pan,
Pavley, Roth, Wieckowski, Wolk
NOES: Anderson, Bates, Fuller, Gaines, Moorlach, Morrell,
Nguyen, Nielsen, Runner, Vidak
NO VOTE RECORDED: Allen, De León, Glazer, Huff, Stone
ASSEMBLY FLOOR: Not available
SUBJECT: Livestock: use of antimicrobial 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
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Agriculture (CDFA) to, in coordination with federal programs and
agencies, develop a program to track antimicrobial drug use in
livestock and the emergence of antimicrobial-resistant bacteria;
and requires CDFA to develop antimicrobial stewardship
guidelines and best management practices on the proper use of
these drugs.
Assembly Amendments clarify when medically important
antimicrobial drugs may be used for preventative purposes,
provide further details regarding the CDFA antimicrobial
monitoring program, and levy penalties for violators of this new
chapter, among other amendments.
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 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
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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 "medically important antimicrobial
drug," "livestock," and "veterinary feed directive."
2) Prohibits, beginning January 1, 2018, the administration of
a medically important antimicrobial drug to livestock unless
ordered by a veterinarian, through a prescription or feed
directive, that has established a veterinarian-client-patient
relationship.
3) Allows, beginning January 1, 2018, the use of a medically
important antimicrobial drug when, in the professional
judgement of a licensed veterinarian, the drug is necessary
for any of the following:
a) To treat a disease or infection.
b) To Control the spread of a disease or infection
c) In relation to surgery or a medical procedure.
4) Allows the use of a medically important antimicrobial drug
when, in the professional judgement of a licensed
veterinarian, it is needed for prophylaxis (prevention) to
address an elevated risk in the contraction of a particular
disease or infection.
5) Prohibits a person from administering a medically important
antimicrobial drug to livestock in a repeated or regular
pattern unless if consistent with #3, above.
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6) Prohibits a person from administering a medically important
antimicrobial drug to livestock solely for the purposes of
promoting weight gain or improving feed efficiency.
7) Allows medically important antimicrobial drugs to be sold,
with a prescription or veterinary feed directive, by
retailers licensed to sell restricted drugs.
8) Requires CDFA, in consultation with the Veterinary Medical
Board, the State Department of Public Health, universities,
and cooperative extensions, to develop antimicrobial
stewardship guidelines and best management practices on the
proper use of these drugs for disease treatment, control, and
prevention.
9) Requires CDFA to consult with livestock producers,
veterinarians and other stakeholder on ensuring livestock
timely access to treatment for producers in rural areas with
limited access to veterinary care.
10)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) Select and administer the appropriate medically
important antimicrobial drug, dose, duration and route of
administration.
c) Use medically important antimicrobial drugs for the
shortest duration necessary and administered to the fewest
animals necessary.
11)States the intent of the Legislature that CDFA coordinate
with specified federal agencies to implement the expanded
antimicrobial resistance surveillance efforts in the National
Action Plan for Combating Antibiotic-Resistant Bacteria.
12)Requires CDFA to gather information, as specified, on
medically important antimicrobial drug sales and usage, as
well as antimicrobial resistant bacteria and livestock
management practice data. Monitoring efforts shall not be
duplicative of federal monitoring programs, and to the extent
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feasible, CDFA shall coordinate with specified federal
agencies to develop these efforts.
13)Requires CDFA to work with willing participants to gather
this data, and participation shall be done in a manner that
does not breach veterinary-client-patient confidentiality
laws.
14)Requires CDFA to report to the Legislature by January 1,
2019, the results of outreach and monitoring efforts.
15)Requires CDFA to seek funds from federal, state, and other
sources to implement the monitoring program.
16)Authorizes CDFA to obtain copies of veterinary feed
directives.
17)Maintains confidentiality of data collected to prevent the
identification of an individual farm or business.
18)Levies a $250 per day civil penalty on persons who violate
this new chapter, or an administrative fine of $500 per day
of violation for a second or subsequent violation. Violators
are also required to attend an educational program on the
judicious use of medically important antimicrobial drugs
within 90 days of the violation. This provision excludes
veterinarians, who are subject to disciplinary sanctions
pursuant to the Veterinary Medicine Practice Act.
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 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
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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. 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
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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
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
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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.
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
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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."
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
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."
Monitoring program. 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. This bill seeks to coordinate
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with this program.
Over-the-counter accessibility. This bill eliminates the OTC
availability of all medically important antimicrobial drugs
administered to livestock. There are concerns from the
livestock industry that this will limit their ability to obtain
the medication necessary to properly care for their livestock,
however this bill recognizes this challenge and several
agricultural organizations, such as the California Cattlemen's
Association, remain neutral on this bill.
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 or similar
existing programs to develop a statewide guidance program.
Opposition. Several organizations have removed their opposition
from this bill, such as the Natural Resources Defense Council,
Environmental Working Group, and CALPIRG (please see the
Assembly Agriculture Committee analysis dated 9/9/2015 for a
more complete list). However, not all of those in opposition
have provided an updated position since the most recent
amendments have been adopted. Therefore, those listed as
"opposed" may in fact have also changed their position to
neutral, however this cannot be verified as of 9/11/2015.
FISCAL EFFECT: Appropriation: No Fiscal
Com.:YesLocal: No
According to the Assembly Appropriations Committee, this bill
will cost approximately $864,000 in FY 2015-16 and $4.8 million
in FY 2016-17 from General and Special Funds to develop
programs, stewardship guidelines, monitoring systems and
procedures, and regulations, as well as begin training,
inspections, and use tracking. Annual General and Special Fund
costs are estimated to be approximately $4.3 million per year
thereafter to continue training, inspections, and tracking.
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Some of these costs may be funded from federal and local
sources, and potentially offset in part with civil fine revenue.
In addition, there are potentially significant costs to the
Veterinary Medical Board and the State Department of Public
Health to help develop stewardship guidelines and training
materials.
SUPPORT: (Verified9/11/15)
Adventist Health
California Academy of Preventive Medicine
California Children's Hospital Association
California Naturopathic Doctors Association
California Optometric Association
California Society of Health-System Pharmacists
California Veterinary Medical Association
Humane Society Veterinary Medical Association
Infectious Disease Association of California
Loma Linda University Health
OPPOSITION: (Verified9/11/15)
Alliance for the Prudent Use of Antibiotics
Animal Welfare Approved
Center for Agriculture and Food Systems, Vermont Law School
Center on Race, Poverty and the Environment
Compassion Over Killing
Diestel Family Turkey Ranch
Friends of the Earth
Hunger Action LA
Institute for Agriculture and Trade Policy
Organic Consumers Association
Physicians for Social Responsibility, Los Angeles
Southern California Public Health Association
Urban Environmental Policy Institute
Women Organizing Resources, Knowledge and Services
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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: Those opposed to this bill 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, the use of 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 U.S. are used in livestock production, where much of
the use is to accelerate animal growth and for disease
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prevention. By continuing to allow antibiotics to be used for
disease prevention, these drugs could still be administered in
low doses to entire herds when there is no disease present and
where other interventions could obviate the need for their use.
(Please see the comments section titled "Opposition" on page 9
for further clarification on the status of these organizations'
opposed position).
Prepared by:Anne Megaro / AGRI. / (916) 651-1508
9/11/15 21:00:10
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