BILL NUMBER: SB 835 INTRODUCED
BILL TEXT
INTRODUCED BY Senator Hill
JANUARY 6, 2014
An act to amend Section 14288 of, and to add Article 4.5
(commencing with Section 18770) to Chapter 4 of Part 3 of Division 9
of, the Food and Agricultural Code, relating to food and agriculture.
LEGISLATIVE COUNSEL'S DIGEST
SB 835, as introduced, Hill. Food-producing animals: medically
important antimicrobial drugs.
Under existing law, the Secretary of Food and Agriculture has the
responsibility of ensuring that food products are not adulterated and
that they are capable for use as human food. A violation of the laws
and regulations relating to the adulteration of livestock or poultry
products is a crime, punishable as specified. Existing law regulates
the sale of livestock drugs by the secretary, and requires livestock
drugs to be registered.
This bill would prohibit the secretary from registering a
medically important antimicrobial drug, as defined, for use on a
food-producing animal, unless prescribed requirements are met. The
bill would provide that a medically important antimicrobial drug
currently registered with the department that does not meet the
prescribed requirements has until January 1, 2017, to meet the
prescribed requirements and reregister with the secretary. The bill
would require a veterinarian-client-patient relationship, as
described, to exist prior to the use of a medically important
antimicrobial drug. Because a violation of the bill's provisions
would be a crime, the bill would impose a state-mandated local
program.
The California Constitution requires the state to reimburse local
agencies and school districts for certain costs mandated by the
state. Statutory provisions establish procedures for making that
reimbursement.
This bill would provide that no reimbursement is required by this
act for a specified reason.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: yes.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 14288 of the Food and Agricultural Code is
amended to read:
14288. The director secretary shall
refuse to register a livestock drug if he or she finds
any of the following is true of the drug:
(a) It is of little or no value for the purpose for which it is
intended to be used.
(b) It is dangerous to the health of livestock if used in
accordance with the instructions.
(c) The instructions for use do not contain adequate warnings
against use in those conditions, whether pathological or normal,
under which its use may be dangerous to the health of livestock or
humans who consume products from such the
livestock, or against unsafe dosage, unsafe duration of use, or
unsafe methods of administration.
(d) If the application and the accompanying material, data, and
information do not comply with the requirements of this chapter or
are insufficient to permit the director
secretary to make the determinations which
that are required by this section.
(e) It is a medically important antimicrobial drug, as defined in
Section 18770, for use in food-producing animals, unless the drug
complies with Section 18771.
SEC. 2. Article 4.5 (commencing with Section 18770) is added to
Chapter 4 of Part 3 of Division 9 of the Food and Agricultural Code,
to read:
Article 4.5. Medically Important Antimicrobial Drugs
18770. For purposes of this article, the following definitions
apply:
(a) "FDA" means the federal Food and Drug Administration.
(b) "Medically important antimicrobial drug" means an
antimicrobial drug listed in Appendix A of the FDA Guidance for
Industry #152, including a critically important, highly important,
and important antimicrobial drug. The secretary may determine that
any updates to this list by the FDA are also medically important
antimicrobial drugs.
18771. To comply with FDA Guidance for Industry #213, dated
December 2013, a medically important antimicrobial drug, including a
combination drug incorporating a medically important anti microbial
drug, shall meet all of the requirements in the guidance document,
including, but not limited to, the following:
(a) To reflect the need for professional oversight by a licensed
veterinarian, the manufacturer shall remove from the approved
production uses on the label of the medically important antimicrobial
drug or combination drug the production indications, including, but
not limited to, "increased rate of weight gain" or "improved feed
efficiency."
(b) The manufacturer shall revise the condition of the use of the
medically important antimicrobial drug or combination drug from over
the counter availability to a marketing status requiring veterinary
prescription, including, but not limited to, the following:
(1) For medicated feed products, a change from over the counter to
veterinary feed directive.
(2) For medicated drinking water products, a change from over the
counter to veterinary prescription.
(c) The medically important antimicrobial drug may only be used to
treat, prevent, or control disease under the supervision of, or by
prescription from, a licensed veterinarian.
18772. There shall be a veterinarian-client-patient relationship
to ensure that a medically important antimicrobial drug is used in a
manner that is consistent with professionally accepted best
practices. For the purposes of this section, a
"veterinarian-client-patient relationship" is a relationship meeting
the requirements of Section 2032.1 of Title 16 of the California Code
of Regulations.
18773. If a medically important antimicrobial drug, or
combination drug, for use in food-producing animals is registered
with the department as of January 1, 2015, and the drug does not
comply with Section 18771, the manufacturer of the medically
important antimicrobial drug, or combination drug, shall have until
January 1, 2017, to reregister the drug with the secretary. The
secretary shall refuse to reregister the drug unless it complies with
Section 18771.
SEC. 3. No reimbursement is required by this act pursuant to
Section 6 of Article XIII B of the California Constitution because
the only costs that may be incurred by a local agency or school
district will be incurred because this act creates a new crime or
infraction, eliminates a crime or infraction, or changes the penalty
for a crime or infraction, within the meaning of Section 17556 of the
Government Code, or changes the definition of a crime within the
meaning of Section 6 of Article XIII B of the California
Constitution.