BILL ANALYSIS AB 1709 Page 1 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." AB 1709 Page 2 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 Page 3 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. AB 1709 Page 4 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 Page 5 California Department of Food and Agriculture (Sponsor) Opposition None on file. Analysis Prepared by : Jim Collin / AGRI. / (916) 319-2084