BILL NUMBER: AB 1709	AMENDED
	BILL TEXT

	AMENDED IN SENATE  AUGUST 17, 2010
	AMENDED IN ASSEMBLY  MAY 5, 2010
	AMENDED IN ASSEMBLY  APRIL 20, 2010
	AMENDED IN ASSEMBLY  APRIL 5, 2010

INTRODUCED BY   Assembly Member Conway

                        FEBRUARY 2, 2010

   An act to amend Sections 9203, 9211, 9212, 9221, 9231, 9241, 9242,
9244, 9245, 9251, 9261, 9263, 9264, 9267, and 9268 of, to amend the
heading of Chapter 1.5 (commencing with Section 9201) of Part 1 of
Division 5 of, to amend the heading of Article 5 (commencing with
Section 9241) of Chapter 1.5 of Part 1 of Division 5 of, to add
Section 9210 to, to add the heading of Article 2 (commencing with
Section 9210) to Chapter 1.5 of Part 1 of Division 5 of, to add,
amend, and renumber Section 9204 of, to repeal Section 9243 of, to
repeal the heading of Article 2 (commencing with Section 9211) of
Chapter 1.5 of Part 1 of Division 5 of, and to repeal and add Section
9205 of, the Food and Agricultural Code, relating to biologics.


	LEGISLATIVE COUNSEL'S DIGEST


   AB 1709, as amended, Conway. Biologics: animal blood and blood
component products: commercial blood banks for animals.
   Existing law defines biologics, requires the Secretary of Food and
Agriculture to license biologic establishments that meet specified
requirements, provides requirements relating to the application for a
biologic license, and requires a certain biologic license
application fee and license renewal fee. A violation of these
provisions is a crime.
   This bill would revise the definition of biologics, prohibit a
person from engaging in the production of animal blood and blood
component products, as defined, for retail sale and distribution
except in a commercial blood bank for animals, as defined, licensed
by the secretary, delete the requirement that the secretary license
biologic establishments and instead require the secretary to license
commercial blood banks for animals that meet specified requirements,
and revise the license application provisions and license application
fee and renewal fee provisions to instead make them applicable to
producers of animal blood and blood component products. Because this
bill would change the definition of an existing crime and create new
crimes, the bill would impose a state-mandated local program.
   Existing law prohibits a person from engaging in the production of
biologics except in an establishment licensed by the United States
Department of Agriculture or the Secretary of Food and Agriculture or
in an establishment producing biologics only for use by the owner or
operator for animals owned by him or her.
   This bill would instead prohibit a person from engaging in the
production of biologics except as permitted under federal law.
   Existing law prohibits the offer for sale or use of any biologic
unless it is registered by the secretary, except that registration is
not required of any biologic manufactured pursuant to the terms of a
valid license issued by the United States Department of Agriculture
unless the secretary finds that, due to local conditions, it is
necessary that the biologic be registered.
   This bill would, instead, prohibit the offer for sale or use of
any biologic unless it is manufactured pursuant to the terms of a
valid license or permit issued by the United States Department of
Agriculture. The bill would also prohibit the offer for sale or use
of any blood or blood component product unless it is produced in an
establishment licensed by the secretary, thereby imposing a
state-mandated local program by creating a new crime.
   Existing law requires the secretary to register any biologic that
meets certain requirements and a biologic that is produced in an
establishment exempt from licensing and that meets certain
requirements, provides requirements relating to the application for
registration of a biologic, and authorizes the secretary to impose
conditions on the production or use of biologics.
   This bill would delete the requirement that the secretary register
biologics and instead require the secretary to register blood or
blood component products that meet certain requirements. The bill
would also require an application for registration of blood or blood
component products to include specified information and would
authorize the secretary to impose conditions on the production or use
of blood or blood component products.
   Existing law provides various enforcement provisions that the
secretary may undertake with respect to biologic licensees and
registrants.
   This bill would revise those enforcement provisions to instead
make them applicable to commercial blood banks for animals licensees
and registrants of blood or blood component products.
   This bill would make other conforming, clarifying, and technical
changes.
   This bill would state that its provisions are declaratory of
existing law as applied to commercial blood banks for animals.
   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.
   This bill would provide that its provisions shall not become
operative until  the first day on or after January 1, 2013, that
 all California  registered   biologics
  that meet the federal definition of biologics,
  biological products  registered  as of
  with the Department of Food and Agriculture by 
December 31, 2010,  obtain a conditional   have
obtained a  United States Veterinary Biological Product License
from the United States Department of Agriculture  Center for
Veterinary Biologics except those products for which the Department
of Food and Agriculture has received written documentation from a
firm that the firm has chosen not to   obtain that license.
The bill would require the Department of Food and Agriculture to
assist, as provided, towards federal biol   ogical products
  licensure  . The bill would also require the
Department of Food and Agriculture to submit a report to the
Legislature on the status of  the biologic registration
transition process   biologics transitioning to federal
biologic  al products   licensure  by June 1,
2011, and every June thereafter until  all those biologics
registered with the department as of December 31, 2010, have obtained
federal licensure   this act becomes operative and,
when it does become operative, to post that fact on its Internet Web
site  .
   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.  The heading of Chapter 1.5 (commencing with Section
9201) of Part 1 of Division 5 of the Food and Agricultural Code is
amended to read:
      CHAPTER 1.5.  COMMERCIAL BLOOD BANKS FOR ANIMALS AND BIOLOGICS


  SEC. 2.  Section 9203 of the Food and Agricultural Code is amended
to read:
   9203.  "Biologics" means all viruses, serums, antibody products,
toxins (excluding substances that are selectively toxic to
microorganisms, for example, antibiotics), or analogous products at
any stage of production, shipment, distribution, or sale, which are
intended for use in the treatment of animals and which act primarily
through the direct stimulation, supplementation, enhancement, or
modulation of the immune system or immune response.
  SEC. 3.  Section 9204 is added to the Food and Agricultural Code,
to read:
   9204.  "Blood and blood component products" means whole blood
collected directly from a donor animal for transfusion or the blood
components for transfusion including packed red blood cells,
platelet-rich plasma, platelet concentrates, fresh plasma, fresh
frozen plasma, frozen plasma, cryoprecipitate, and cryosupernatant.
Antibody products like hyperimmune serums are considered "biologics"
and are excluded from this definition of blood and blood component
products.
  SEC. 4.  Section 9204 of the Food and Agricultural Code is amended
and renumbered to read:
   9206.  "Production" means collection of blood or the preparation,
testing, processing, storage, or distribution of blood or blood
component products for the purpose of transfusion.
  SEC. 5.  Section 9205 of the Food and Agricultural Code is
repealed.
  SEC. 6.  Section 9205 is added to the Food and Agricultural Code,
to read:
   9205.  "Commercial blood bank for animals" means an establishment
that produces animal blood or blood component products to market and
sell for use in the cure, mitigation, treatment, or prevention of
injury or disease in animals.
  SEC. 7.  The heading of Article 2 (commencing with Section 9211) of
Chapter 1.5 of Part 1 of Division 5 of the Food and Agricultural
Code is repealed.
  SEC. 8.  The heading of Article 2 (commencing with Section 9210) is
added to Chapter 1.5 of Part 1 of Division 5 of the Food and
Agricultural Code, to read:

      Article 2.  Animal Blood and Blood Component Products
Production and Biologics Production


  SEC. 9.  Section 9210 is added to the Food and Agricultural Code,
to read:
   9210.  No person shall engage in the production of animal blood
and blood component products for retail sale and distribution except
in a commercial blood bank for animals licensed by the secretary.
  SEC. 10.  Section 9211 of the Food and Agricultural Code is amended
to read:
   9211.  No person shall engage in the production of biologics
except as permitted under federal law.
  SEC. 11.  Section 9212 of the Food and Agricultural Code is amended
to read:
   9212.  The secretary shall license establishments as commercial
blood banks for animals that meet all of the following:
   (a) Operate under conditions, and use methods of production, to
ensure that the animal blood and blood component products will not be
contaminated, dangerous, or harmful.
   (b) Produce animal blood and blood component products under the
direct supervision of a person qualified in the field.
   (c) Maintain onsite records containing information documenting how
the animal was acquired and any history of blood draws or use of
anesthesia on the animal.
  SEC. 12.  Section 9221 of the Food and Agricultural Code is amended
to read:
   9221.  An application for a license for any establishment that
produces, or proposes to produce, animal blood and blood component
products shall be made on forms issued by the secretary. The
application shall contain all of the following:
   (a) The name and address of the person who owns the place,
establishment, or institution in which it is proposed to produce
animal blood and blood component products.
   (b) The name and address of the person who shall be in charge of
the production of animal blood and blood component products.
   (c) The type of animal blood and blood component products that
shall be produced.
   (d) A full description of the building, including its location,
facilities, equipment, and apparatus to be used in the production of
animal blood and blood component products.
   (e) A written protocol that addresses all of the following:
   (1) Maximum length of time for donation by animal donors, or
minimum health parameters for animal donors.
   (2) Frequency and volume of blood collected from animal blood
donors.
   (3) Socialization and exercise programs for animal blood donors.
   (4) Method of identification of each animal, including microchip
or tattoo.
   (5) Ongoing veterinary care, including an annual physical exam and
vaccination schedule for animals held in blood donor facilities.
   (6) Husbandry standards for feeding, watering, sanitation,
housing, handling, and care in transit, with minimums based on the
standards set forth pursuant to the federal Animal Welfare Act in
Part 3 (commencing with Section 3.1) of Subchapter A of Chapter 1 of
Title 9 of the Code of Federal Regulations.
   (7) Implementation of a permissive adoption program.
   (f) An "oversight letter" identifying the oversight veterinarian
who will be responsible for oversight of the facility. The letter
shall be from the oversight veterinarian, and shall be maintained on
file by the secretary. Oversight veterinarians shall be licensed to
practice veterinary medicine in California. In the event of a change
of the oversight veterinarian, it is the oversight veterinarian's
responsibility to give notice to the secretary of the termination of
the oversight veterinarian within 30 days of the termination date of
the oversight veterinarian. An oversight letter from the incoming
oversight veterinarian shall be submitted to the secretary within 30
days of the termination date of the prior oversight veterinarian.
   (g)  Additional information that the secretary finds is necessary
for the proper administration and enforcement of this chapter.
  SEC. 13.  Section 9231 of the Food and Agricultural Code is amended
to read:
   9231.  The license application fee and license renewal fee under
this chapter for an establishment proposing to produce or producing
animal blood and blood component products shall be as follows:
   (a) The application and annual license fee shall be two hundred
fifty dollars ($250) for each establishment, which shall be the fee
for the fiscal year, or portion thereof, ending June 30 of each year.
When an applicant is a city, county, state, or district, or an
official thereof, no fee shall be required under this section.
   (b) Licenses shall be renewed every year. The annual renewal fee
shall be paid on or before the first day of July of each year.
   (c) Fees may be increased by the department to cover the
department's reasonable costs incurred in connection with performing
the annual inspection required by Sections 9266 and 9268.
   (d) The fees required by this section are maximum, and may be
fixed by the secretary at a lesser amount for any fiscal year
whenever he or she finds that the cost of administering this chapter
can be defrayed from revenues derived from the lower fees.
  SEC. 14.  The heading of Article 5 (commencing with Section 9241)
of Chapter 1.5 of Part 1 of Division 5 of the Food and Agricultural
Code is amended to read:

      Article 5.  Blood or Blood Component Product Registration


  SEC. 15.  Section 9241 of the Food and Agricultural Code is amended
to read:
   9241.  No person shall offer for sale or use any of the following:

   (a) Any biologic unless it is manufactured pursuant to the terms
of a valid license or permit issued by the United States Department
of Agriculture.
   (b) Any blood or blood component product unless it is produced in
an establishment licensed by the secretary.
  SEC. 16.  Section 9242 of the Food and Agricultural Code is amended
to read:
   9242.  The secretary shall register blood or a blood component
product that meets all of the following requirements:
   (a) It is produced under acceptable procedures.
   (b) It has been demonstrated to the secretary that the blood or
blood component product is safe and noninjurious to animal health.
   (c) It has been demonstrated to the secretary that the blood or
blood component product is of value for the purpose intended.
   (d) It is labeled for proper handling and use, and is not
misrepresented.
   (e) It is produced in an establishment that meets the requirements
of Section 9210.
  SEC. 17.  Section 9243 of the Food and Agricultural Code is
repealed.
  SEC. 18.  Section 9244 of the Food and Agricultural Code is amended
to read:
   9244.  An application for registration of blood or a blood
component product shall include both of the following:
   (a) A protocol of the methods of production in detail that is
followed in the production of the product.
   (b) A sample of the label to be placed on the blood or blood
component product.
  SEC. 19.  Section 9245 of the Food and Agricultural Code is amended
to read:
   9245.  The secretary may impose such conditions on the production
or use of blood or blood component products as he or she deems
necessary to accomplish the purposes of this chapter.
  SEC. 20.  Section 9251 of the Food and Agricultural Code is amended
to read:
   9251.  The secretary may adopt reasonably necessary rules and
regulations for the administration and enforcement of this chapter.
  SEC. 21.  Section 9261 of the Food and Agricultural Code is amended
to read:
   9261.  License for any commercial blood bank for animals or
registration of any blood or blood component product may be denied,
suspended, or revoked by the secretary for failure to meet the
requirements of this chapter or for the violation of any provision of
this chapter, or of any rule or regulation adopted by the secretary
under this chapter. The proceedings shall be conducted in accordance
with Chapter 5 (commencing with Section 11500) of Part 1 of Division
3 of Title 2 of the Government Code.
  SEC. 22.  Section 9263 of the Food and Agricultural Code is amended
to read:
   9263.  If the secretary finds that blood or blood component
products do not conform to the requirements of Section 9242 or the
use or continued use of such products constitutes an immediate danger
to animals, the secretary may, after notice, suspend the
registration of those blood or blood component products or license of
an establishment producing those blood or blood component products
pending a hearing and final decision.
  SEC. 23.  Section 9264 of the Food and Agricultural Code is amended
to read:
   9264.  (a) If the secretary finds blood or blood component
products that do not meet the requirements of Section 9242, the
secretary may order those blood or blood component products to be
held on the premises where found or elsewhere until he or she has
determined that the products may be safely released for the purposes
intended.
   (b) The secretary may order the destruction of any blood or blood
component products under a hold order if the blood or blood component
products cannot be made to meet the requirements of Section 9242.
  SEC. 24.  Section 9267 of the Food and Agricultural Code is amended
to read:
   9267.  Notwithstanding Section 4827 of the Business and
Professions Code, for commercial blood banks for animals licensed by
the department, anesthesia shall be performed pursuant to Section
4826 of the Business and Professions Code.
  SEC. 25.  Section 9268 of the Food and Agricultural Code is amended
to read:
   9268.  The requirements set forth in subdivision (c) of Section
9212, subdivision (e) of Section 9221, subdivision (c) of Section
9231, and Sections 9266 and 9267:
   (a) Shall not apply to those facilities required to be inspected
by the United States Department of Agriculture in accordance with the
Animal Welfare Act (Chapter 54 (commencing with Section 2131) of
Title 7 of the United States Code).
   (b) Shall apply to those facilities housing blood donor animals
under contract with commercial blood banks for animals licensed by
the department.
   (c) Shall not apply to private veterinarians who maintain their
own, in-office blood donor animals for use in their own practice.
  SEC. 26.  The Legislature finds and declares that the amendments
made to Chapter 1.5 (commencing with Section 9201) of Part 1 of
Division 5 of the Food and Agricultural Code by this act do not
constitute a change in, but are declaratory of, existing law as
applied to commercial blood banks for animals.
  SEC. 27.  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. 
  SEC. 28.    (a) This act shall not become
operative until all California registered biologics that meet the
federal definition of biologics, registered as of December 31, 2010,
obtain a conditional United States Veterinary Biological Product
License from the United States Department of Agriculture.
   (b) The Department of Food and Agriculture shall submit a report
to the Legislature on the status of the biologic registration
transition process by June 1, 2011, and every June thereafter until
all biologics that meet the federal definition of biologics
registered with the department as of December 31, 2010, have obtained
federal licensure, at which time the department shall post that fact
on its Internet Web site. 
   SEC. 28.    (a) To ensure uninterrupted availability
of California-specific biological products, this act, except for
subdivisions (b), (c), and (d) of this section, shall not become
operative until the first day on or after January 1, 2013, that all
California biological products, as defined in Section 101.2 of Title
9 of the Code of Federal Regulations, registered with the Department
of Food and Agriculture by December 31, 2010, have obtained a United
States Veterinary Biological Product License from the United States
Department of Agriculture (USDA) Center for Veterinary Biologics
except those products for which the Department of Food and
Agriculture has received written documentation from a firm that the
firm has chosen not to obtain that license. However, new
registrations of biologics will not be processed by the Department of
Food and Agriculture after December 31, 2010. When this act becomes
operative, the Department of Food and Agriculture shall post that
fact on its Internet Web site.  
   (b) It is the intent of the Legislature that the role of the
Department of Food and Agriculture shall continue to be to advocate
and interact with interested parties and the USDA Center for
Veterinary Biologics to assist in the process for biologics of
importance to California's livestock industry, and as defined in
Sections 101.2 and 101.3 of Title 9 of the Code of Federal
Regulations, to obtain a United States Veterinary Biological Product
License.  
   (c) The Department of Food and Agriculture shall submit a report
to the Legislature on the status of biologics transitioning to United
States Veterinary Biological Product Licensure and of any additional
products as described in subdivision (d) by June 1, 2011, and every
June thereafter until this act becomes operative as set forth in
subdivision (a).  
   (d) The Department of Food and Agriculture shall use its best
efforts to immediately interact with the USDA Center for Veterinary
Biologics to assist in the process for California biological
products, as defined in Section 101.2 of Title 9 of the Code of
Federal Regulations, registered with the Department of Food and
Agriculture by December 31, 2010, to obtain a United States
Veterinary Biological Product License. Upon request, the Department
of Food and Agriculture shall assist research sponsors in obtaining
the authorizations for shipment or delivery as an experimental
biological product, according to Section 103.3 of Title 9 of the Code
of Federal Regulations, for products currently under development to
ensure ongoing progress toward obtaining a United States Veterinary
Biological Product License.