BILL NUMBER: SB 835 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY JUNE 4, 2014
AMENDED IN SENATE MARCH 26, 2014
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 amended, Hill. Food animals: medically important
antimicrobial drugs.
Under existing law, the Secretary of Food and Agriculture has the
responsibility of ensuring that food products
livestock or poultry raised for the production of human food
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, which
that is administered to food animals, as
defined, through feed or drinking water, unless prescribed
requirements are met. The bill would, except as specified, 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
administered to food animals through feed or drinking water .
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 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 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 secretary to make the determinations
that are required by this section.
(e) It is a medically important antimicrobial drug, as defined in
Section 18770, which that is
administered to food animals, as defined in Section 4825.1 of the
Business and Professions Code, through feed or drinking water, 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) "Food animal" has the same meaning as defined in subdivision
(c) of Section 4825.1 of the Business and Professions Code.
(c) "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 shall have
the discretion to consider any changes to this list by the FDA to
determine whether a substance is a medically important antimicrobial
drug drug, as that appendix may be amended, unless the
secretary determines that the amendment to the appendix includes a
drug that is not a critically important, highly important, or
important antimicrobial drug .
(d) "Veterinary feed directive" is the directive described in
Section 354 of Title 21 of the United States Code.
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 antimicrobial
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) When administered through feed or drinking water ,
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
administered to food animals through feed or drinking water 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. (a) (1) If a medically important antimicrobial drug, or
combination drug, for use in food 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.
(2) Notwithstanding paragraph (1), if a drug label reviewed by the
FDA under the Guidance for Industry #213 is delayed beyond January
1, 2017, the secretary shall have the authority to continue
registering the drug during the FDA's review period.
(3) If revision revisions to the
veterinary feed directive causes cause
the FDA to delay implementation of the Guidance for Industry #213,
the secretary shall have the authority to extend the time period by
which a manufacturer is required to reregister the drug pursuant to
paragraph (1) to be consistent with the delay in the implementation
of the guideline guidance . If the
secretary extends the time period for reregistration, the extension
shall not be later than the federal implementation date of the
guidance.
(b) If revisions to the veterinary feed directive causes
cause the FDA to revise the Guidance for
Industry #213, the secretary shall have the authority to promulgate
regulations to ensure that California law is consistent with the
revisions to the guidance.
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.