Bill Text: CA AB1468 | 2009-2010 | Regular Session | Amended
Bill Title: Biologics: licensure: registration.
Spectrum: Partisan Bill (Republican 1-0)
Status: (Introduced - Dead) 2010-02-02 - From committee: Filed with the Chief Clerk pursuant to Joint Rule 56. [AB1468 Detail]
Download: California-2009-AB1468-Amended.html
BILL NUMBER: AB 1468 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY JANUARY 5, 2010
INTRODUCED BY Assembly Member Conway
FEBRUARY 27, 2009
An act to amend Section 9211 of Sections
9211, 9241, 9266, 9267, 9268, 9269, and 9272 of, to amend the heading
of Article 5 (commencing with Section 9241) of Chapter 1.5 of Part 1
of Division 5 of, to repeal Sections 9212, 9242, 9243,
9244, 9245, 9261, 9262, 9263, and 9264 of, and to repeal Article 3
(commencing with Section 9221), Article 4 (commencing with Section
9231), and Article 6 (commencing with Section 9251) of Chapter 1.5 of
Part 1 of Division 5 of, the Food and Agricultural Code,
relating to biologics.
LEGISLATIVE COUNSEL'S DIGEST
AB 1468, as amended, Conway. Biologics.
Biologics: licensure: registration.
Existing law requires the Secretary of Food and Agriculture to
license establishments, including commercial blood banks for animals,
that produce, or propose to produce, biologics and that meet
specified requirements, provides requirements relating to the
application for a license, and requires a certain license application
fee and license renewal fee.
This bill would delete the requirement that the secretary license
those biologic establishments and would delete those related
provisions regarding license applications and fees.
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 the person has a valid license or permit issued
by the United States Department of Agriculture.
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 would delete those related provisions regarding the
registration application and the imposition of conditions.
Existing law authorizes the secretary to adopt rules and
regulations for the administration and enforcement of the provisions
relating to biologics.
This bill would delete that authority.
Existing law provides various enforcement provisions that the
secretary may undertake with respect to biologic licensees and
registrants.
This bill would delete those enforcement provisions.
Existing law requires the Department of Food and Agriculture, or
humane officers under contract with the department, to inspect
commercial blood banks for animals licensed by the department at
least once a year to ensure compliance with certain protocols.
This bill would, instead, authorize humane officers to inspect
commercial blood banks for animals to ensure compliance with certain
husbandry standards, written protocol requirements, and with a
requirement for the maintenance of an affiliation with an identified
oversight veterinarian for the facility.
This bill would also make various conforming changes and other
technical changes.
Existing law prohibits a person from engaging in the production of
biologics except as specified, including, among others, in an
establishment licensed by the Secretary of Food and Agriculture.
This bill would make technical, nonsubstantive changes to those
provisions.
Vote: majority. Appropriation: no. Fiscal committee: no
yes . State-mandated local program: no.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
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 director under this chapter.
(c) In an establishment licensed by the director.
SEC. 2. Section 9212 of the Food and
Agricultural Code is repealed.
9212. The secretary shall license biologic establishments that
meet all of the following:
(a) Operate under conditions, and use methods of production, to
insure that the biologics will not be contaminated, dangerous, or
harmful.
(b) Produce biologics 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 onsite records containing information
documenting how the animal was acquired and any history of blood
draws or use of anesthesia on the animal.
SEC. 3. Article 3 (commencing with Section 9221)
of Chapter 1.5 of Part 1 of Division 5 of the Food and
Agricultural Code is repealed.
SEC. 4. Article 4 (commencing with Section 9231)
of Chapter 1.5 of Part 1 of Division 5 of the Food and
Agricultural Code is repealed.
SEC. 5. 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 Registration Sale
or Use of Biologics
SEC. 6. Section 9241 of the Food and
Agricultural Code is amended to read:
9241. No person shall offer for sale or use 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 the
person has 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 .
SEC. 7. Section 9242 of the Food and
Agricultural Code is repealed.
9242. The director shall register any biologic 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) It has been demonstrated to the director that such a biologic
is safe and noninjurious to human or animal health.
(d) It has been demonstrated to the director that such a biologic
is of value for the purpose intended.
(e) It is labeled for proper handling and use, and is not
misrepresented.
(f) It is produced in an establishment that meets the
requirements of subdivision (a) or (c) of Section 9211.
SEC. 8. 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. 9. Section 9244 of the Food and
Agricultural Code is repealed.
9244. An application for registration of a biologic shall include
both of the following:
(a) A protocol of methods of production in detail which is
followed in the production of the product.
(b) A sample of the label to be placed on the biologic.
SEC. 10. Section 9245 of the Food and
Agricultural Code is repealed.
9245. The director may impose such conditions on the production
or use of biologics as he deems necessary to accomplish the purposes
of this chapter.
SEC. 11. Article 6 (commencing with Section 9251)
of Chapter 1.5 of Part 1 of Division 5 of the Food and
Agricultural Code is repealed.
SEC. 12. Section 9261 of the Food and
Agricultural Code is repealed.
9261. License for any establishment or registration of any
biologic may be denied, suspended, or revoked by the director 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 under this chapter. The proceedings shall be
conducted in accordance with Chapter 5 (commencing with Section
11500), Part 1, Division 3, Title 2 of the Government Code.
SEC. 13. Section 9262 of the Food and
Agricultural Code is repealed.
9262. The biologics prepared prior to July 1, 1975, in
laboratories licensed pursuant to Chapter 4 (commencing with Section
1600) of Division 2 of the Health and Safety Code, which have an
expiration date of July 1, 1975, or later, are not subject to the
provisions of this chapter.
SEC. 14. Section 9263 of the Food and
Agricultural Code is repealed.
9263. If the director finds that biologics 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 may, after notice, suspend the registration of such biologics or
license of an establishment producing such biologics pending a
hearing and final decision.
SEC. 15. Section 9264 of the Food and
Agricultural Code is repealed.
9264. If the director finds a serial or serials of a registered
biologic which do not meet the requirements of Section 9242 or 9243,
he may order such serial or serials to be held on the premises where
found or elsewhere until he has determined that the products may be
safely released for the purposes intended.
The director may order the destruction of any products under such
a hold order if the products cannot be made to meet the requirements
of Section 9242 or 9243.
SEC. 16. Section 9266 of the Food and
Agricultural Code is amended to read:
9266. The department, or humane Humane
officers under contract with the department, shall
may inspect commercial blood banks for animals
licensed by the department at least once a year to
ensure compliance with the protocols required by
subdivision (e) of Section 9221. all of the following:
(a) 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 I of
Title 9 of the Code of Federal Regulations.
(b) Written protocols, established by, and to be followed by, the
commercial blood bank for animals, that address 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) Implementation of a permissive adoption program.
(c) Maintenance of an affiliation with an identified oversight
veterinarian for the facility. Oversight veterinarians shall be
licensed to practice veterinary medicine in California. An "oversight
letter" identifying the oversight veterinarian shall be maintained
on the premises of the commercial animal blood bank.
SEC. 17. 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 that operate in California
, anesthesia shall be performed by a California licensed
veterinarian or by a registered veterinary technician under the
direct supervision of a California licensed veterinarian.
SEC. 18. 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 commercial animal blood banks and
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. 19. Section 9269 of the Food and
Agricultural Code is amended to read:
9269. (a) Except as provided in subdivision (b), all records
held by the department relating to this chapter, including, but not
limited to, records relating to applications
state biologic establishment licenses and registrations prior to
January 1, 2011 , fees, or inspections required by this
chapter, shall be confidential and not subject to disclosure under
the California Public Records Act contained in Chapter 3.5
(commencing with Section 6250) of Division 7 of Title 1 of the
Government Code.
(b) Notwithstanding subdivision (a), records held by the
department relating to this chapter shall be accessible to law
enforcement officers with jurisdiction over any matter covered by
this chapter.
SEC. 20. Section 9272 of the Food and
Agricultural Code is amended to read:
9272. The provisions of this chapter shall not apply (1)
to facilities primarily engaged in the collection,
preparation, testing, processing, storage, or distribution of human
blood or blood products, provided such facility is licensed pursuant
to Section 1601 or 1602 1602.5 of the
Health and Safety Code and any biologic as defined in
Section 9203 produced by such facility is sold or distributed only to
an establishment licensed by this chapter or (2) to clinical
laboratories licensed pursuant to Chapter 3 (commencing with Section
1200) of Division 2 of the Business and Professions Code whose only
biologics are autogenous bacterins prepared at the request of
licensed veterinarians .
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.
