BILL ANALYSIS �
SB 835
Page 1
SENATE THIRD READING
SB 835 (Hill)
As Amended July 3, 2014
Majority vote
SENATE VOTE :34-1
AGRICULTURE 7-0 APPROPRIATIONS 17-0
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|Ayes:|Eggman, Olsen, Dahle, |Ayes:|Gatto, Bigelow, |
| |Pan, Quirk, Salas, Yamada | |Bocanegra, Bradford, Ian |
| | | |Calderon, Campos, |
| | | |Donnelly, Eggman, Gomez, |
| | | |Holden, Jones, Linder, |
| | | |Pan, Quirk, |
| | | |Ridley-Thomas, Wagner, |
| | | |Lowenthal |
|-----+--------------------------+-----+--------------------------|
| | | | |
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SUMMARY : This bill would codify the Food and Drug Administration's
(FDA) Guidance for Industry (GIF) #213 dated December 2013, by
requiring the Secretary (Secretary) of the California Department of
Food and Agriculture (CDFA) 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 (MIAM) drug.
Specifically, this bill :
1)Codifies the FDA Guidance for Industry #213 dated December 2013.
2)Defines "MIAM 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 CDFA to refuse to register a MIAM drug
administered to food animals through feed or drinking water unless
the MIAM 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;
and,
b) Requires drug manufacturers to change the over-the-counter
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availability of MIAM drugs, as specified.
4)Requires a veterinarian-client-patient relationship to ensure that
medically important antimicrobial drugs are used according to
professionally accepted best practices.
5)Authorizes the Secretary to promulgate regulations to ensure that
California regulations are consistent with GFI #213 should it be
revised.
FISCAL EFFECT : According to the Assembly Committee on
Appropriations, there are minor and absorbable loss of revenue to
CDFA as a result of reductions in registration fees currently paid
for medically important antimicrobial drugs; negligible enforcement
costs to the Veterinary Medical Board.
COMMENTS : Antimicrobial drugs have been widely used in human
medicine since the 1940s. Antimicrobial drugs have significant
health benefits in both human and animal medicine, and are important
and valuable tools used to treat and prevent illness and infection.
Incidences of antimicrobial resistance have been recorded over time
and, if left unchecked, pose a threat to public health.
The Centers for Disease Control and Prevention (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. 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
CDC recommends phasing out.
In December 2013, FDA released the final draft of GFI #213. GFI
#213 contains nonbinding recommendations to industry regarding the
use of MIAM 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 MIAM 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.
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According to the author, this bill is necessary to preserve the
effectiveness of MIAM by putting into California law the voluntary
guidelines issued by FDA to phase out the nontherapeutic use of MIAM
in food-producing animals, and to require veterinary oversight of
these drugs.
Supporters state this bill would prohibit the registration of MIAM
in livestock and poultry for purposes of growth promotion and feed
efficiency, or other uses without veterinary oversight. Furthermore,
producers would no longer be able to acquire antibiotics over the
counter, but would have to get a veterinarian's prescription or
veterinary feed directive for MIAM use in feed or water. Supporters
state this oversight will help ensure antibiotics are used to treat
sick animals, to control the spread of diseases present in the flock
or herd, and under well-defined circumstances, to prevent disease
when necessary. This will in turn help ensure that MIAMs are used
in a more judicious manner.
Opponents state because the recent FDA guidelines only recommend an
end to antibiotic use for growth promotion, the guidelines will do
little to curb the inappropriate use of antibiotics on livestock.
Opponents point out that most antibiotics that are used for growth
promotion in livestock are also used for disease prevention.
According to opponents, the most effective way to lower MIAM use is
to prohibit all antibiotic use in livestock production except for
the treatment of sick animals.
Some supporters and opponents to this bill expressed the desire to
collect data in-state on veterinary prescriptions for antibiotics
administered in feed. This information could shed substantial light
on the use of MIAM in food animal production. Without some form of
tracking, there isn't a way to gauge the success of federal and
state policies aimed at reducing antibiotic overuse and curbing the
spread of drug-resistant bacteria. Furthermore, the data may enable
both producers and public health officials to spot and remedy
problematic overuse that raise human health concerns.
Analysis Prepared by : Victor Francovich / AGRI. / (916) 319-2084
FN:
0004437
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