Biologics: animal blood and blood component products: commercial blood banks for animals.

Existing law defines biologics, requires the Secretary of Food and Agriculture to license biologic establishments that meet specified requirements, provides requirements relating to the application for a biologic license, and requires a certain biologic license application fee and license renewal fee. A violation of these provisions is a crime. This bill would revise the definition of biologics, prohibit a person from engaging in the production of animal blood and blood component products, as defined, for retail sale and distribution except in a commercial blood bank for animals, as defined, licensed by the secretary, delete the requirement that the secretary license biologic establishments and instead require the secretary to license commercial blood banks for animals that meet specified requirements, and revise the license application provisions and license application fee and renewal fee provisions to instead make them applicable to producers of animal blood and blood component products. Because this bill would change the definition of an existing crime and create new crimes, the bill would impose a state-mandated local program. Existing law prohibits a person from engaging in the production of biologics except in an establishment licensed by the United States Department of Agriculture or the Secretary of Food and Agriculture or in an establishment producing biologics only for use by the owner or operator for animals owned by him or her. This bill would instead prohibit a person from engaging in the production of biologics except as permitted under federal law. Existing law prohibits the offer for sale or use of any biologic unless it is registered by the secretary, except that registration is not required of any biologic manufactured pursuant to the terms of a valid license issued by the United States Department of Agriculture unless the secretary finds that, due to local conditions, it is necessary that the biologic be registered. This bill would, instead, prohibit the offer for sale or use of any biologic unless it is manufactured pursuant to the terms of a valid license or permit issued by the United States Department of Agriculture. The bill would also prohibit the offer for sale or use of any blood or blood component product unless it is produced in an establishment licensed by the secretary, thereby imposing a state-mandated local program by creating a new crime. Existing law requires the secretary to register any biologic that meets certain requirements and a biologic that is produced in an establishment exempt from licensing and that meets certain requirements, provides requirements relating to the application for registration of a biologic, and authorizes the secretary to impose conditions on the production or use of biologics. This bill would delete the requirement that the secretary register biologics and instead require the secretary to register blood or blood component products that meet certain requirements. The bill would also require an application for registration of blood or blood component products to include specified information and would authorize the secretary to impose conditions on the production or use of blood or blood component products. Existing law provides various enforcement provisions that the secretary may undertake with respect to biologic licensees and registrants. This bill would revise those enforcement provisions to instead make them applicable to commercial blood banks for animals licensees and registrants of blood or blood component products. This bill would make other conforming, clarifying, and technical changes. This bill would state that its provisions are declaratory of existing law as applied to commercial blood banks for animals. The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement. This bill would provide that no reimbursement is required by this act for a specified reason. This bill would provide that its provisions shall not become operative until the first day on or after January 1, 2013, that all Californiabiological products registered with the Department of Food and Agriculture by December 31, 2010, have obtained a United States Veterinary Biological Product License from the United States Department of Agriculture Center for Veterinary Biologics except those products for which the Department of Food and Agriculture has received written documentation from a firm that the firm has chosen not to obtain that license. The bill would require the Department of Food and Agriculture to assist, as provided, toward federal biological products licensure. The bill would also require the Department of Food and Agriculture to submit a report to the Legislature on the status of biologics transitioning to federal biological products licensure by June 1, 2011, and every June thereafter until this act becomes operative and, when it does become operative, to post that fact on its Internet Web site.