BILL ANALYSIS
SENATE FOOD and AGRICULTURE COMMITTEE
Senator Dean Florez, Chairman
BILL NO: AB 1709 HEARING: 6/15/10
AUTHOR: Conway FISCAL: Yes
VERSION: 5/5/10 CONSULTANT: John Chandler
Biologics: animal blood and blood component products: commercial
blood banks for animals.
BACKGROUND AND EXISTING LAW
California Department of Food and Agriculture (CDFA) Veterinary
Biologics Program (biologics program) was established in 1974 as
a result of the 1971-72 Exotic Newcastle Disease outbreak in
Southern California. The program was modeled after the United
States Department of Agriculture's (USDA) Center for Veterinary
Biologics Program. The program licensed biologics products used
in California and ensured that all available veterinary
biologics were safe, pure, potent, and efficacious. CDFA has
one veterinarian and $120,000 of General Fund dedicated
primarily to the biologics program. Biologic products are
medications that activate an animal's immune system response to
fight off a disease.
Current law defines biologics as: "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 vaccines, 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
microorganisms.
In 1985, the federal government amended the Virus-Serum-Toxin
Act authorizing USDA to regulate intrastate, as well as
interstate, movement of biological products and broadened their
authority to issue regulations. Regulations were implemented
for an exemption from the federal licensure for products
produced under an approved state program for exclusive use in
the state. California obtained USDA approval for this exemption
and is the only state currently holding this exemption for a
state biologics program.
Currently, there are three licensed biologic companies in
California that are also licensed under USDA's Center for
Veterinary Biologics Program. There are 10 biologic products
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that are licensed for use in California and could be approved
for use by USDA under conditional restricted use in order for
their continued use within California.
SB 1342 (Kuehl), Chapter 822, Statutes of 2002, established
additional protocols for commercial blood banks for animals that
are licensed by the CDFA.
PROPOSED LAW
AB 1709 deletes the current veterinary biologics licensing law
and replaces it with licensing requirements for animal blood
banks. Specifically, this bill:
Replaces the existing state veterinary biologics
licensing program with licensing requirements for
businesses handling animal blood and blood products.
Prohibits a person from engaging in the production of
biologics unless they have a valid permit or license from
the United States Department of Agriculture (USDA).
Requires the CDFA to submit to the Legislature by June
1, 2011, a report on the status of the transition of
biologics licenses to the federal government. In addition,
requires CDFA to report annually on the transition until
all state licensed biologics businesses have transitioned
to the federal license.
States that this act will not become operative until all
California registered biologics businesses as of December
31, 2010, obtain a conditional United States Veterinary
Biological Product License from USDA.
COMMENTS
1.CDFA is sponsoring AB 1709 to eliminate the current state
biologics program without impacting the program for commercial
blood banks for animals and transition California to the
federal biologics program to address funding shortfalls in the
current state program. Based on a recent USDA audit of the
California biologics program, it is estimated that the cost to
maintain a federally compliant program would be approximately
$428,000 and three personnel years, further training or
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special recruitment at higher salaries than are currently
allowable, and contracting with a private laboratory for
regulatory testing of products. Without sufficient funding or
AB 1709 CDFA would not be able to maintain sufficient
oversight which could result in a potentially disruptive
action by USDA to disallow the California exemption to the
federal biologics program.
2.AB 1709 would maintain the requirements for licensing
commercial blood banks for animals under the state program.
One of the requirements for a licensed establishment is to
produce animal blood and blood component products under the
direct supervision of a qualified person in the field. There
does not seen to be any clear definition of a qualified person
or how a person would be deemed qualified in the field. The
committee may wish to consider further explanation of a
"person qualified in the field".
3.AB 1709 would maintain the state required registration for
blood or blood component products that meet specified
requirements. The first requirement is that the blood or
blood component products are produced under "acceptable
procedures." The committee may wish to consider if the bill
should further define "acceptable procedures."
PRIOR ACTIONS
Assembly Floor 72-0
Assembly Appropriations16-0
Assembly Agriculture 8-0
SUPPORT
Animal Blood Bank
California Department of Food and Agriculture
California Veterinary Medical Association
OPPOSITION
None received
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