Bill Text: CA SB835 | 2013-2014 | Regular Session | Amended

NOTE: There are more recent revisions of this legislation. Read Latest Draft

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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-Amended.html

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BILL NUMBER: SB 835	AMENDED
	BILL TEXT

	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-producing  
Food  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,   which 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. 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,  for use in food-producing animals, 
 which 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. 

   (b) 
    (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  may
determine that   shall have the discretion to consider
 any  updates   changes  to this list
by the FDA  are also   to determine whether a
substance is a  medically important antimicrobial  drugs
  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  anti
microbial   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)  The   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 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-producing   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 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.  
   (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. 
  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.