SENATE RULES COMMITTEE
Office of Senate Floor Analyses
(916) 651-1520 Fax: (916) 327-4478
SB 27
UNFINISHED BUSINESS
Bill No:
Author:
Amended:
Vote:
SB 27
Hill (D)
9/10/15
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
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 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
SB 27
Page 2
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 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.).
SB 27
Page 3
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 veterinarianclient-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.
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
SB 27
Page 4
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 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-clientpatient 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.
SB 27
Page 5
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 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
SB 27
Page 6
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 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.
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
SB 27
Page 7
antimicrobial use in food animals (livestock), the Action Plan seeks to implement
FDA’s guidances for industry, described later in this analysis.
The United States Department of Agriculture (USDA) currently operates national
laboratory systems that survey national animal health and monitor antimicrobial
resistance: the National Animal Health Monitoring System (NAHMS) and the
National Antimicrobial Resistance Monitoring System (NARMS). NAHMS was
created in 1983 to collect and analyze data on animal health, management, and
productivity and to conduct national studies on livestock populations. NAHMS is
recognized as a statistical unit under the Confidential Information Protection and
Statistical Efficiency Act (CIPSEA), which allows producers or livestock owners
to voluntarily provide sensitive and confidential information such as on-farm
management practices and animal health issues. USDA states that this is vital to
encourage voluntary participation and to maintain high response rates.
NARMS was established in 1996 by the FDA in conjunction with the CDC and
USDA to monitor trends in antimicrobial resistance from human, retail meat, and
food animal samples. The goals and objectives of NARMS’ monitoring program
are to monitor trends in antimicrobial resistance among foodborne bacteria,
conduct research to better understand the emergence and spread of resistant
bacteria, and to assist the FDA in decision making for the approval of
antimicrobial drugs for animals.
The California Animal Health and Food Safety (CAHFS) Laboratory System,
created as a partnership between CDFA and the UC Davis School of Veterinary
Medicine, is the state entity responsible for providing rapid diagnostic testing for
animal health diseases, and those diseases that affect humans. Most recently,
CAHFS has been involved in detecting avian influenza in both commercial and
backyard poultry but also conducts testing on any animal brought to the lab with
other concerns such as poisoning, salmonella or other bacterial infections, rabies,
and other serious health issues for both livestock and pets. CAHFS is part of the
National Animal Health Laboratory Network, which has been included as a
component of national surveillance efforts in President Obama’s Action Plan for
combating antimicrobial resistance.
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
SB 27
Page 8
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 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.
SB 27
Page 9
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.:
Yes
Local: 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. 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: (Verified 9/11/15)
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
SB 27
Page 10
Loma Linda University Health
OPPOSITION: (Verified 9/11/15)
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
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.”
SB 27
Page 11
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 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
**** END ****