Amended in Assembly June 4, 2014

Amended in Senate March 26, 2014

Senate Bill No. 835

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 begin delete food products end delete begin insert livestock or poultry raised for the production of human food end insert 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, begin delete which end delete begin insert that end insert 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 begin insert administered to food animals through feed or drinking water end insert . 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, begin delete which end delete begin insert that end insert 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 begin delete 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 end delete begin insert 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 end insert .

(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 begin insert , end insert 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
begin insert administered to food animals through feed or drinking water end insert 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 begin delete revision end delete begin insert revisions end insert to the veterinary feed directive begin delete causes end delete
begin insert cause end insert 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 begin delete guideline end delete begin insert guidance end insert . 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 begin delete causes end delete begin insert cause end insert 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.