BILL ANALYSIS
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|SENATE RULES COMMITTEE | AB 1709|
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THIRD READING
Bill No: AB 1709
Author: Conway (R)
Amended: 5/5/10 in Assembly
Vote: 21
SENATE FOOD AND AGRICULTURE COMMITTEE : 5-0, 6/15/10
AYES: Florez, Emmerson, Hancock, Hollingsworth, Wolk
SENATE APPROPRIATIONS COMMITTEE : Senate Rule 28.8
ASSEMBLY FLOOR : 72-0, 5/20/10 (Consent) - See last page
for vote
SUBJECT : Biologics: animal blood and blood component
products:
commercial blood banks for animals
SOURCE : Department of Food and Agriculture
DIGEST : This bill deletes the current veterinary
biologics licensing law and replaces it with licensing
requirements for animal blood banks.
ANALYSIS : The 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
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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 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, establishes
additional protocols for commercial blood banks for animals
that are licensed by the CDFA.
This bill:
1. Prohibits a person from engaging in the production of
biologics unless they have a valid permit or license
from the USDA.
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2. 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.
3. 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
CDFA is sponsoring this bill 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 special recruitment at
higher salaries than are currently allowable, and
contracting with a private laboratory for regulatory
testing of products. Without sufficient funding of this
bill, CDFA is unable to maintain sufficient oversight which
could result in a potentially disruptive action by USDA to
disallow the California exemption to the federal biologics
program.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: Yes
SUPPORT : (Verified 6/28/10)
California Department of Food and Agriculture (source)
Animal Blood Bank
California Veterinary Medical Association
ASSEMBLY FLOOR :
AYES: Adams, Ammiano, Anderson, Arambula, Bass, Beall,
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Bill Berryhill, Tom Berryhill, Blakeslee, Block,
Blumenfield, Bradford, Brownley, Buchanan, Caballero,
Charles Calderon, Carter, Chesbro, Conway, Cook, Coto,
Davis, De Leon, DeVore, Emmerson, Eng, Feuer, Fong,
Fuentes, Fuller, Furutani, Gaines, Galgiani, Garrick,
Gilmore, Hagman, Hall, Hayashi, Hernandez, Hill, Huber,
Huffman, Jeffries, Jones, Knight, Lieu, Logue, Bonnie
Lowenthal, Ma, Mendoza, Miller, Monning, Nestande,
Niello, Nielsen, Norby, V. Manuel Perez, Portantino,
Ruskin, Salas, Saldana, Silva, Skinner, Smyth, Solorio,
Audra Strickland, Swanson, Torlakson, Torres, Torrico,
Tran, Yamada
NO VOTE RECORDED: De La Torre, Evans, Fletcher, Harkey,
Nava, Villines, John A. Perez, Vacancy
TSM:do 8/4/10 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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