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. begin delete Food-producing end delete begin insert Food end insert 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, begin delete for use on a food-producing animal, end delete begin insert which is administered to food animals, as defined, through feed or drinking water, end insert unless prescribed requirements are met. The bill would begin insert , except as specified, end insert 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 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 for use in food-producing animals, end delete begin insert which is
administered to food animals, as defined in Section 4825.1 of the
Business and Professions Code, through feed or drinking water, end insert
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.

begin insert

(b) “Food animal” has the same meaning as defined in
subdivision (c) of Section 4825.1 of the Business and Professions
Code.

end insert begin delete

(b)

end delete

begin insert (c) end insert  “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 begin delete may determine
that end delete begin insert shall have the discretion to consider end insert any begin delete updates end delete begin insert changes end insert to
this list by the FDA begin delete are also end delete begin insert to determine whether a substance is
a end insert medically important antimicrobial begin delete drugs end delete begin insert drug end insert .

begin insert

(d) “Veterinary feed directive” is the directive described in
Section 354 of Title 21 of the United States Code.

end insert

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
begin delete anti microbial end delete begin insert antimicrobial end insert 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)  begin delete The end delete begin insert When administered through feed or drinking water the end insert
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.  

begin insert (a) end insert begin insert   end insert begin insert (1) end insert begin insert   end insert If a medically important antimicrobial drug,
or combination drug, for use in begin delete food-producing end delete begin insert food end insert 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.

begin insert

(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.

end insert begin insert

(3) If revision to the veterinary feed directive causes 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. If the secretary extends the time
period for reregistration, the extension shall not be later than the
federal implementation date of the guidance.

end insert begin insert

(b) If revisions to the veterinary feed directive causes 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.

end insert

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.