BILL ANALYSIS ------------------------------------------------------------ |SENATE RULES COMMITTEE | AB 1709| |Office of Senate Floor Analyses | | |1020 N Street, Suite 524 | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ------------------------------------------------------------ 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 CONTINUED AB 1709 Page 2 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. CONTINUED AB 1709 Page 3 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, CONTINUED AB 1709 Page 4 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 **** END **** CONTINUED