BILL ANALYSIS Ó
-----------------------------------------------------------------
|SENATE RULES COMMITTEE | SB 835|
|Office of Senate Floor Analyses | |
|1020 N Street, Suite 524 | |
|(916) 651-1520 Fax: (916) | |
|327-4478 | |
-----------------------------------------------------------------
THIRD READING
Bill No: SB 835
Author: Hill (D)
Amended: 3/26/14
Vote: 21
SENATE AGRICULTURE COMMITTEE : 5-0, 4/1/14
AYES: Galgiani, Cannella, Berryhill, Lieu, Wolk
SENATE APPROPRIATIONS COMMITTEE : Senate Rule 28.8
SUBJECT : Food animals: medically important antimicrobial
drugs
SOURCE : Author
DIGEST : This bill codifies the Food and Drug Administrations
(FDA) Guidance for Industry #213 dated December 2013 by
requiring the Secretary of the Department of Food and
Agriculture (DFA) 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. Requires
a veterinarian-client-patient relationship, as described, to
exist prior to the use of a medically important antimicrobial
drug.
ANALYSIS : Existing federal law:
1.States the FDA is responsible for protecting public health by
assuring the safety, effectiveness, quality, and security of
human and veterinary drugs.
CONTINUED
SB 835
Page
2
2.Establishes, within FDA, the Center for Veterinary Medicine
which regulates the manufacture and distribution of drugs that
will be administered to animals.
Existing state law:
1.Requires the Secretary of DFA to register over-the-counter
livestock drugs and regulate their use for safety and
efficacy.
2.Requires a license for retail sales of restricted livestock
drugs.
3.Requires each licensee shall keep a record of each sale of a
restricted drug, including the kind and quantity of the drug;
sale date; purchaser's name, address and signature; and any
other information deemed necessary by the Secretary.
This bill:
1.Codifies the FDA Guidance for Industry #213 dated December
2013.
2.Defines "medically important antimicrobial drug" to mean a
drug listed in the FDA Guidance for Industry #152 which
categorizes these drugs as critically important, highly
important, or important antimicrobial drugs.
3.Requires the Secretary of DFA to refuse to register a
medically important antimicrobial drug administered to food
animals through feed or drinking water unless the drug
complies with the specified requirements below:
A. Requires drug manufacturers to remove from the label of
said drugs the approved use for growth promotion or feed
efficiency.
B. Requires drug manufacturers to change the
over-the-counter availability of said drugs to 1) requiring
a veterinary feed directive (VFD) if the drug is
administered in animal feed or 2) requiring a veterinary
prescription if the drug is administered in drinking water.
CONTINUED
SB 835
Page
3
C. Requires that medically important antimicrobial drugs
administered through feed or water may only be used under
the supervision of a veterinarian to treat, prevent, or
control disease.
1.Requires a veterinarian-client-patient relationship to ensure
that medically important antimicrobial drugs are used
according to professionally accepted best practices.
2.Requires drug manufacturers to comply with these provisions by
January 1, 2017, and reregister medically important
antimicrobial drugs with the Secretary of DFA.
3.Authorizes the Secretary to continue registering a drug during
FDA's GFI #213 review period should the review be delayed
beyond January 1, 2017.
4.Authorizes the Secretary to extend the implementation date if
revisions to the VFD cause FDA to delay implementation of GFI
#213.
5.Authorizes the Secretary to promulgate regulations to ensure
that California regulations are consistent with GFI #213
should revisions to the VFD cause the FDA to revise GFI #213.
Background
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.
CONTINUED
SB 835
Page
4
Antibiotics are also used in food-producing animals for the
purpose of promoting growth, which the CDC recommends phasing
out. The FDA is currently developing guidance to promote
judicious use of antimicrobials, as described below.
Over the last few years, the FDA has worked on creating
Guidelines for Industry (GFI) regarding the judicious use of
medically important antimicrobial drugs. In a series of three
guidances, the FDA has compiled a list of medically important
antimicrobial drugs categorized by their importance to human
health (GFI #152), developed principals that determine the
appropriate or judicious use of such drugs by limiting use to
only when necessary to maintain animal health and with
veterinary oversight or consultation (GFI #219), and provided
recommendations as to the implementation of these guidelines
(GFI #213). The FDA concludes that using medically important
antimicrobial drugs for animal growth promotion or feed
efficiency is not a judicious use and that veterinary oversight
or consultation is necessary when using these drugs.
In December 2013, the FDA released the final draft of GFI #213.
This document contains nonbinding recommendations to industry
regarding the use of medically important antimicrobial drugs in
the feed and drinking water of food-producing animals. The FDA
intends to work with drug companies to help them voluntarily
implement the recommendations, which 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) include veterinary oversight of
these drugs when used in the feed or water of food-producing
animals.
Prior Legislation
SB 416 (Florez, 2009) would have authorized a school district to
make every effort to purchase poultry and meat products that
have not been treated with nontherapeutic antibiotics. SB 416
failed passage in the Senate.
SB 1058 (Alquist, Chapter 296, Statutes of 2008) establishes the
Medical Facility Infection Control and Prevention Act, which
requires specified hospitals to implement procedures for
screening, prevention, and reporting of hospital-related
infections, including MRSA, an antimicrobial-resistant
CONTINUED
SB 835
Page
5
bacterium.
SB 739 (Speier, Chapter 526, Statutes of 2006) establishes the
Hospital Infectious Disease Control Program, which requires the
Department of Public Health and specified hospitals to implement
a disease surveillance and hospital associated infection
prevention program.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: Yes
SUPPORT : (Verified 4/28/14)
California Cattlemen's Association
California State Grange
California Veterinary Medical Association
The Pew Charitable Trusts
Infectious Disease Association of California
Health Officers Association of California
Health Care Without Harm
OPPOSITION : (Verified 4/28/14)
Consumers Union
ARGUMENTS IN SUPPORT : The California Veterinary Medical
Association writes in support of this bill stating that it
"?ensures that this important relationship between veterinarians
and food producers will continue to remain strong, in accordance
with the law."
Health Care Without Harm states, "This bill helps protect public
health by ending the misuse of antibiotics for the purposes of
growth promotion in animal agriculture. Moreover, it increases
medical oversight over our valuable drugs by requiring
prescriptions by veterinarians when antibiotics are administered
to animals through food and water."
ARGUMENTS IN OPPOSITION : Consumers Union states in opposition
that under this bill, agribusiness would be able to continue the
regular feeding of antibiotics to animals, potentially every day
of their lives, for disease prevention. To combat antibiotic
resistance, the daily feeding of antibiotics to animals must be
ended and that antibiotics should be used in animals in the way
CONTINUED
SB 835
Page
6
they are used in humans - only for treatment of a specific
illness, for a limited period of time.
JL:nl 4/29/14 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
**** END ****
CONTINUED