BILL ANALYSIS �
SB 835
Page 1
Date of Hearing: July 2, 2014
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Mike Gatto, Chair
SB 835 (Hill) - As Amended: June 4, 2014
Policy Committee:
AgricultureVote:7-0
Urgency: No State Mandated Local Program:
Yes Reimbursable: No
SUMMARY
This bill codifies the US Food and Drug Administration (FDA)
Guidance for Industry #213, requiring the Secretary (Secretary)
of the California Department of Food and Agriculture (CDFA) to
refuse to register a drug administered in the feed or drinking
water of food animals if that drug is a medically important
antimicrobial drug. Specifically, this bill:
1)Defines "medically important antimicrobial drug" as a drug
listed in the FDA Guidance for Industry #152, which
categorizes those drugs as critically important, highly
important, or important antimicrobial drugs.
2)Requires the Secretary to refuse to register a medically
important antimicrobial drug administered to food animals
through feed or drinking water unless the drug complies with
the following requirements:
a) The drug manufacturer has removed growth promotion and
feed efficiency from the approved uses on the drug label.
b) The drug manufacturer has ceased offering the drug over
the counter and requires a veterinary feed directive if the
drug is to be administered in animal feed or a veterinary
prescription if the drug is to be administered in drinking
water.
c) The drug administered through feed or water is used only
under the supervision of a veterinarian to treat, prevent,
or control disease.
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3)Requires a "veterinarian-client-patient" relationship (as
defined under existing regulations) exist to ensure that
medically important antimicrobial drugs are used according to
professionally accepted best practices.
4)Requires drug manufacturers to comply with these provisions by
January 1, 2017, and reregister medically important
antimicrobial drugs with the Secretary, although the Secretary
may continue to register a drug during the FDA's review period
under Guidance for Industry #213 if that period is delayed
beyond January 1, 2017 or extend the implementation date if
the FDA delays implementation of the Guidance.
FISCAL EFFECT
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
1) Purpose. According to the author, this bill will help
preserve the effectiveness of medically important
antimicrobial drugs through codification of FDA guidance to
phase out nontherapeutic use of those drugs in food-producing
animals. Supporters assert the bill will prohibit use of
medically important antimicrobials for growth promotion and
feed efficiency while requiring veterinary oversight of drug
use, ensuring antibiotics are used only to treat sick animals
and control the spread of disease.
2) Antibiotic Resistant Bacteria. The Centers for Disease
Control (CDC) estimates more than two million people are
infected with antibiotic-resistant bacteria in the United
States each year, with at least 23,000 of those infections
resulting in death. The CDC claims the use of antibiotics is
the single most important factor leading to antibiotic
resistance around the world. According to the World Health
Organization, antibiotics are used in greater quantities in
healthy food-producing animals than in the treatment of
disease in humans.
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In response to growing antibiotic resistance, the FDA issued
several industry recommendations regarding the use of
medically important antimicrobial drugs in the feed and
drinking water of food-producing animals. The recommendations
contained in Guidance for Industry #152, #213, and #219
establish lists of antibiotics important to human health,
promote judicious use of those drugs in food production, and
encourage veterinary oversight to ensure compliance with
industry best practices.
3) Opposition. Opponents, including CALPIRG and the Center for
Food Safety, argue the bill does not go far enough to prevent
the inappropriate use of antibiotics on food-producing
animals. In particular, opponents claim that many antibiotics
are used for multiple purposes, including growth promotion as
well as disease prevention, and this bill would not restrict
that use so long as disease prevention was at least one of the
objectives for use. As a result, opponents argue total use of
medically important antimicrobials will not be significantly
reduced, and that only a prohibition on all use except for the
treatment of sick animals will lead to meaningful reductions.
4) Staff Comment. While the bill currently states that "[t]here
shall be a veterinarian-client-patient relationship" to ensure
the use of medically important antimicrobials is consistent
with best practices, it is silent as to who is responsible,
and therefore may be held accountable, for ensuring the
existence of the relationship.
The author and the Committee may wish to consider amending the
paragraph beginning page 4, line 5 to clarify that "no person
shall administer a medically important antimicrobial drug"
through feed or drinking water except pursuant to a
veterinarian-client-patient relationship.
4) Related Legislation.
a) SB 1311 (Hill) requires general acute care hospitals to
implement an antimicrobial stewardship policy that meets
specified criteria, and to report to the Legislature by
January 1, 2018 on hospital compliance with the
requirement. SB 1311 is before this committee today.
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b) AB 1437 (Mullin) bans the sale, in California, of a
livestock or poultry product if the animal was given a
medically important antimicrobial for nontherapeutic use.
AB 1437 is in the Assembly Agriculture Committee, and has
not been heard.
Analysis Prepared by : Joel Tashjian / APPR. / (916) 319-2081