BILL ANALYSIS
AB 1709
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Date of Hearing: April 14, 2010
ASSEMBLY COMMITTEE ON AGRICULTURE
Cathleen Galgiani, Chair
AB 1709 (Conway) - As Amended: April 5, 2010
SUBJECT : Biologics: animal blood and blood component products:
commercial blood banks for animals.
SUMMARY : Deletes the existing state biologics licensure law,
recasting it to cover animal blood and blood components and
products; makes biologics production and biologics products subject
to federal authority and permitting, in lieu of the state.
Specifically, this bill :
1)Recasts the definition of "Biologics" to mean all viruses serum,
antibody, toxins (except for antibiotics) or analogous products
at any stage of production through sale which are intended for
use in the treatment of animals and act through direct
stimulation, supplementation, enhancement, or modulation of the
immune system or immune response.
2)Adds the definition of "Blood and blood components products" to
mean whole blood collected directly from a donor animal for
transfusion or 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 are considered
"biologics" and are excluded from this definition.
3)Changes the definition of "Production", strikes references to
"biologics" and replaces it with "blood and blood component
products produced for the purpose of transfusion."
4)Deletes the definition of "Serial."
5)Adds the definition for "Commercial blood bank for animals" to
mean establishments that produce animal blood or blood component
products to market and sell for use in the care, mitigation,
treatment, or prevention of disease in animals.
6)Renames the Article from "Biologics Production" to "Animal Blood
and Blood Component Products Production and Biologics
Production."
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7)Requires all engaged in the production of animal blood and blood
component products for retail sale and distribution, except in a
commercial blood bank for animals, to be licensed by the
California Department of Food and Agriculture (CDFA).
8)Requires all engaged in the production of biologics to be in
accordance with federal law and deletes the exemption for their
production and use by an owner or operator of a facility of
animals owned by him or her, or licensed by CDFA.
9)Creates the license for commercial blood banks for animals while
deleting the license for biologic facilities meeting the
following conditions:
a) Operate under conditions that ensure animal blood and blood
components, rather than biologics, will not be contaminated,
dangerous, or harmful;
b) Produce animal blood and blood components rather than
biologics under direct supervision of a person qualified in
the field; and,
c) Maintain onsite records of the animal histories of draws.
10)Makes conforming changes replacing "biologics" with "animal
blood and blood components," and striking redundant language.
11)Restricts the sale or use of biologics unless they are
manufactured pursuant to a valid permit issued by the United
States Department of Agriculture (USDA) and animal blood and
blood components must be produced in a facility licensed by CDFA.
12)Deletes the requirement to register biologic production that was
exempt form licensure.
EXISTING LAW provided definitions, licensure and prohibitions on
the production and use of biologics used in the prevention or
treatment of, disease in animals, other than man. (Food and
Agricultural Code, Chapter 1.5 (commencing with Section 9201) of
Part 1, Division 5.)
Amendments to the federal Virus-Serum-Toxic Act of 1985 authorized
USDA to regulate intrastate and interstate movement of biologics
products. The Code of Federal Regulations (9CFR 107.2) authorized
an exemption from federal licensure for products produced under
AB 1709
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approved state programs for exclusive use within the respective
state. (California holds this exemption.)
FISCAL EFFECT : This bill is keyed "fiscal" by Legislative Counsel.
COMMENTS : CDFA has sponsored AB 1709, which proposes to eliminate
the statutes for biologics that allow a state exemption from USDA
authority for the use and production of animal disease prevention
and treatment products within California. California is the only
state that continues to have this federal exemption for these
products. According to CDFA, there are currently three firms
licensed by CDFA and producing biologic products in California and
they also hold federal licenses for the production of these
products.
A recent USDA audit of CDFA's current program found that funding
shortfalls have jeopardized their ability to perform the needed
specialty training, laboratory testing, and regulatory enforcement
activities, to ensure the consumers that these products meet the
requirements of being pure, safe, potent and efficacious. Further,
it is stated by CDFA that USDA has agreed to provide a transition
period to all companies and assist with the transition of those
products currently registered with CDFA over to USDA, and these
products will remain available during the transition according to
CDFA.
This program was created in 1974 as a result of the 1971-72 Exotic
Newcastle Disease outbreak in southern California and modeled after
USDA's Center for Veterinary Biologics program. If CDFA were to
continue this program, they estimate needing an additional $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, in
order to maintain a federally compliant 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. This would require the State
Veterinarian to make a recommendation to USDA for the need of these
regional products. Biologic products are medications that activate
an animal's immune system response to fight off a disease.
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The committee may wish to ask the sponsor if such a recommendation
would be coming from the State Veterinarian, in order to ensure the
continuation of these products. Another issue of concern is the
fact that many of these products have been approved for many years
and the information used for their approval may not be available
for resubmission to USDA, causing the need to do new testing and
research in order to meet the requirements for licensure. With
many of these products, while they are critical to the industry,
are not produced in large enough quantities to make it financially
feasible to pay for the cost of retesting and research for their
approval, causing some manufacturers to drop those products. The
committee may wish to ask the sponsor if this could occur, and if
so, what alternatives does the industry have to provide disease
control in their animals?
Further, these companies are licensed to produce "autogenous
vaccines" which deal specifically with a particular flock or herd
of animals. Once they are approved for these autogenous vaccines
they may continue to produce them. Autogenous vaccines are not
industrially mass-produced vaccines but autogenous vaccines are
individual, specific, so to say tailor-made vaccines for specific
areas or regions. Autogenous vaccines are: flock or herd
specific; pathogen specific; and, assistance for the immune system.
These pathogens are obtained from an infected flock or herd by
swab are carefully inactivated and finally administered to the
flock or herd again. By this procedure, the animals' immunity is
influenced in such a way that the infection gets healed or at
least alleviated. The success of a therapy with autogenous
vaccines thus depends on the capture of the "right" pathogen and
has a limited life expectancy before the right pathogen has to
recaptured and the autogenous vaccine redeveloped.
Currently, there are two state licensed blood banks that produce 11
blood products. A blood product treats medical conditions dealing
with the blood supply of an animal. Blood products that are live
vaccines must be treated as such for licensing purposes. The
committee may wish to clarify if these types of products would be
licensed by CDFA or USDA, and if by USDA, would there be a cost,
and what would that be, to have them licensed?
REGISTERED SUPPORT / OPPOSITION :
Support
AB 1709
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California Department of Food and Agriculture (Sponsor)
Opposition
None on file.
Analysis Prepared by : Jim Collin / AGRI. / (916) 319-2084