BILL NUMBER: AB 1709 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY APRIL 5, 2010
INTRODUCED BY Assembly Member Conway
FEBRUARY 2, 2010
An act to amend Section 9211 of the Food and Agricultural
Code, 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.
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 make technical, nonsubstantive changes to
those provisions 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.
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: no
yes . State-mandated local program: no
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 the following products which are
used for the diagnosis and detection of, and for the prevention or
treatment of, disease in animals other than man: serum, blood,
vaccines, live vaccine, killed vaccine, tissue vaccine, autogenous
vaccine, live virus, killed virus, live bacterial culture, killed
bacterial culture, bacterin, hormone, tissue extract, gland extract,
gland preparation, insulin, and similar products made from human or
animal tissues or micro-organisms 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:
9204. 9206. "Production" means
collection of biologic material, blood or the
preparation, testing, processing, storage, or distribution of
biologics blood or blood component products
for the purpose of transfusion .
SEC. 5. Section 9205 of the Food and
Agricultural Code is repealed.
9205. "Serial" means the total quantity of a biological product
in final composition which has been mixed in a single container and
identified by number.
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
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.
Article 2. Biologics Production
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 in any of the following: as permitted
under federal law.
(a) In an establishment licensed by the United States Department
of Agriculture.
(b) In an establishment producing biologics only for use by the
owner or operator of that establishment for animals owned by him or
her. Biologics produced in such an establishment shall be registered
by the director under this chapter.
(c) In an establishment licensed by the director.
SEC. 11. Section 9212 of the Food and
Agricultural Code is amended to read:
9212. The secretary shall license biologic
establishments as commercial blood banks for animals that
meet all of the following:
(a) Operate under conditions, and use methods of production, to
insure ensure that the
biologics animal blood and blood component products
will not be contaminated, dangerous, or harmful.
(b) Produce biologics animal blood and
blood component products under the direct supervision of a
person qualified in the field of production of biologics
.
(c) For those commercial blood banks
for animals licensed by the department, maintain
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, biologics
animal blood and blood component products shall be made on
forms to be 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
biologics animal blood and blood component
products .
(b) The name and address of the person who shall be in charge of
biologics the production of animal
blood and blood component products .
(c) The type of biologics 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 biologics
the production of animal blood and blood
component products .
(e) A written protocol for a commercial blood bank for
animals 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
biologics 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) For commercial blood banks for animals licensed by
the department, fees 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. Biologic 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
registered by the director pursuant to this article, except,
however, no such registration shall be required of any biologic
manufactured pursuant to the terms of a valid license
or permit issued by the United States Department of Agriculture
unless the director finds that, due to local conditions, it
is necessary that the biologic be registered in order to assure that
it have value for the purpose intended and it is safe to use in this
state .
(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 director secretary shall
register any biologic blood or a blood
component product that meets all of the following requirements:
(a) It is produced under acceptable procedures , which
include tests to insure its purity and safety .
(b) The production and use of such type of biologic has not been
specifically forbidden or disapproved by the director, the United
States Department of Agriculture, or the United States Public Health
Service.
(c)
(b) It has been demonstrated to the director
secretary that such a biologic
the blood or blood component product is safe and
noninjurious to human or animal health.
(d)
(c) It has been demonstrated to the director
secretary that such a biologic
the blood or blood component product is of value
for the purpose intended.
(e)
(d) It is labeled for proper handling and use, and is
not misrepresented.
(f)
(e) It is produced in an establishment that meets the
requirements of subdivision (a) or (c) of Section
9211 9210 .
SEC. 17. Section 9243 of the Food and
Agricultural Code is repealed.
9243. The director shall register a biologic, if it is produced
in an establishment exempt from licensing pursuant to subdivision (b)
of Section 9211 and meets the requirements of subdivisions (a), (b),
and (c) of Section 9242.
SEC. 18. Section 9244 of the Food and
Agricultural Code is amended to read:
9244. An application for registration of a biologic
blood or a blood component product shall include
both of the following:
(a) A protocol of the methods of production in detail
which that is followed in the
production of the product.
(b) A sample of the label to be placed on the biologic
blood or blood component product .
SEC. 19. Section 9245 of the Food and
Agricultural Code is amended to read:
9245. The director secretary may
impose such conditions on the production or use of biologics
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 director 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 establishment
commercial blood bank for animals or registration of any
biologic blood or blood component product
may be denied, suspended, or revoked by the director
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
director 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 director secretary
finds that biologics blood or blood component
products do not conform to the requirements of Section 9242
or 9243 or the use or continued use of such
products constitutes an immediate danger to persons or
animals, he the secretary
may, after notice, suspend the registration of such
biologics those blood or blood component products
or license of an establishment producing such
biologics 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 director
secretary finds a serial or serials of
a registered biologic which blood or blood component
products that do not meet the requirements of Section 9242
or 9243 , he the secretary
may order such serial or serials 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.
The director
(b) The secretary may order the
destruction of any blood or blood component products under
such a hold order if the blood or blood
component products cannot be made to meet the requirements of
Section 9242 or 9243 .
SEC. 24. Section 9267 of the Food and
Agricultural Code is amended to r ead:
9267. Notwithstanding Section 4827 of the Business and
Professions Code, for commercial blood banks for animals licensed by
the department, anesthesia shall be performed by a
California licensed veterinarian or by a registered veterinary
technician under the direct supervision of a California licensed
veterinarian 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 9265, 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) , or to federal biologics
licensees .
(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. 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.
SECTION 1. Section 9211 of the Food and
Agricultural Code is amended to read:
9211. No person shall engage in the production of biologics
except in any of the following:
(a) In an establishment licensed by the United States Department
of Agriculture.
(b) In an establishment producing biologics only for use by the
owner or operator of that establishment for animals owned by him or
her. Biologics produced in such an establishment shall be registered
by the secretary under this chapter.
(c) In an establishment licensed by the secretary.