Bill Text: CA SB835 | 2013-2014 | Regular Session | Enrolled
Bill Title: Food animals: medically important antimicrobial drugs.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Vetoed) 2014-09-29 - In Senate. Consideration of Governor's veto pending. [SB835 Detail]
Download: California-2013-SB835-Enrolled.html
BILL NUMBER: SB 835 ENROLLED
BILL TEXT
PASSED THE SENATE AUGUST 13, 2014
PASSED THE ASSEMBLY AUGUST 11, 2014
AMENDED IN ASSEMBLY JULY 3, 2014
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, Hill. Food animals: medically important antimicrobial
drugs.
Under existing law, the Secretary of Food and Agriculture has the
responsibility of ensuring that 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, 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 of Food and Agriculture 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 prohibit a person from administering a
medically important antimicrobial drug through feed or drinking water
except pursuant to a veterinarian-client-patient relationship, as
described. 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.
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, 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, 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. A person shall not administer a medically important
antimicrobial drug through feed or drinking water except pursuant to
a veterinarian-client-patient relationship to ensure the 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. (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 revisions to the veterinary feed directive 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 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 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.
