AB 1282

Bill Subjects

Abstract

(1) Existing law, the Veterinary Medicine Practice Act, provides for the licensure and registration of veterinarians and the regulation of the practice of veterinary medicine by the Veterinary Medical Board in the Department of Consumer Affairs. Under the act, prescribed actions constitute the practice of veterinary medicine. The act makes a violation of its provisions a crime. This bill would include in the actions that constitute the practice of veterinary medicine the collection of blood from an animal for the purpose of transferring or selling that blood and blood component products, as defined, to a licensed veterinarian for use at a registered premises, except in certain circumstances. By expanding the scope of an existing crime, this bill would impose a state-mandated local program. (2) Existing law permits a registered veterinary technician or a veterinary assistant to administer a drug, including a controlled substance, under the direct or indirect supervision of a licensed veterinarian when done pursuant to the order, control, and full professional responsibility of a licensed veterinarian. This bill would also permit a registered veterinary technician or veterinary assistant to collect blood from an animal for the purpose of transferring or selling the blood and blood component products to a licensed veterinarian at a registered premises, under the direct or indirect supervision of a licensed veterinarian, as specified. (3) Existing law provides for the licensure of commercial blood banks for animals by the Secretary of Food and Agriculture. Existing law also defines a "commercial blood bank for animals" to mean an establishment that produces animal blood or blood component products to market and sell for use in the cure, mitigation, treatment, or prevention of injury or disease in animals. This bill would establish, within the Veterinary Medicine Practice Act, new procedures governing community blood banks for animals and would impose new requirements on veterinarians engaged in the production of animal blood and blood component products. The bill would define a "community blood bank" as a commercial blood bank for animals that produces animal blood or blood component products solely from community-sourced animals whose owners voluntarily consent to the donation. The bill would require each veterinarian who is licensed in California and engages in the production of animal blood or blood component products to meet specified conditions, including following current and best practices on community animal blood banking, using methods of production that are consistent with current standards of care and practice for the field of veterinary transfusion medicine, and obtaining informed written consent of the owner of the animal blood donor. The bill would prohibit a veterinarian or a community blood bank operating under these provisions from providing payment to a person who provides an animal for the purpose of donating that animal's blood and blood component products for use in their practice and for retail sale and distribution. The bill would authorize the Veterinary Medical Board to establish a community blood bank registration fee and an annual renewal fee to be paid by community blood banks to cover the costs associated with oversight and inspection of the premises. The bill would prohibit the fees from exceeding the reasonable regulatory costs of administering, implementing, and enforcing these provisions. The bill would require a community blood bank operating under the above-described provisions to comply with specified blood and blood component product registration requirements imposed under existing Food and Agricultural Code provisions. The bill would also require a community blood bank to submit a quarterly report to the Department of Food and Agriculture every 3 months that includes, among other information, the number of donations from community-sourced animals during that quarter, by species of animal. The bill would provide that a violation of these provisions by a community blood bank constitutes cause for corrective action or various other actions by the Veterinary Medical Board. The bill would define related terms, for purposes of carrying out these provisions, including "captive closed colony" and "community sourced." (4) Existing law prohibits a person from engaging in the production of animal blood and blood component products for retail sale and distribution except in a commercial blood bank for animals licensed by the Secretary of Food and Agriculture that meet certain criteria. A violation of these provisions is a crime. This bill would instead prohibit a person from engaging in the production of animal blood and blood component products for retail sale and distribution except in a captive closed-colony commercial blood bank for animals licensed by the secretary or in accordance with the above-described provisions governing community blood banks for animals. The bill would require each community blood bank to register blood and blood component products with the secretary in accordance with existing procedures. The bill would require the Department of Food and Agriculture to discontinue its licensing program for commercial blood banks for animals that produce canine blood, as defined, and blood component products sourced from captive closed-colony dogs within 18 months of the secretary making specified findings about the amount of canine blood sold in the state, and satisfying other conditions. The bill would require the calculation of canine blood to be done separately, with whole blood, packed red blood cells, and fresh frozen plasma being measured as separate amounts in estimated milliliters based on weight in grams. The bill would require the department to annually submit specified canine blood collection information to specified members of the Legislature and the Veterinary Medical Board. The bill would require the department, in collaboration with the Veterinary Medical Board, technical experts in animal blood banking, and any other relevant stakeholders, by March 1, 2023, to develop and publish on its internet website a "Community Animal Blood Banking Guidance Resource" or other documents that provide veterinarians, at a minimum, accurate, clear, and concise information regarding best management practices for operating community blood banks. The bill would also prohibit the secretary from accepting new applications to license a commercial blood bank for animals that produce canine blood or blood component products sourced from captive closed-colony dogs. The bill would also require that the secretary, when licensing establishments as captive closed-colony commercial blood banks, to only license establishments that, among other conditions, keep, house, or maintain all animal donors within California state boundaries. The bill would authorize closed-colony blood banks to transition to community-sourced models and continue to operate in accordance with specified provisions. By expanding the scope of a crime, the bill would impose a state-mandated local program. (5) Existing law requires an application for a license for an establishment that produces, or proposes to produce, animal blood and blood component products to be made on a form issued by the Secretary of Food and Agriculture and to contain specific information, including a written protocol that addresses the length of time for donation by animals, among other requirements. This bill would specify that the application for a license applies to any establishment that produces, or proposes to produce, animal blood and blood component products from a closed-colony blood bank. The bill would require the written protocol to be consistent with current standards of care and practice for the field of veterinary transfusion medicine and would require that protocol to include bloodborne pathogen testing for all dog and cat blood donors, as prescribed. The bill would prohibit a commercial blood bank for animals from discriminating against veterinarians licensed in California in the sale of animal blood or blood component products. The bill would specify that a commercial blood bank for animals that refuses to sell animal blood or blood component products to a veterinarian in circumstances in which that blood bank has an available supply may be deemed by the secretary to be in violation of this provision. (6) Existing law requires the licensee application fee and license renewal fee for an establishment proposing to produce or producing animal blood and blood component products to be $250 for each establishment. This bill would increase the application and annual license fees to $1,000 for each establishment proposing to produce or producing animal blood and blood component products from a closed-colony blood bank and would allow for these fees to be adjusted annually for inflation. The bill would authorize the Department of Food and Agriculture to set inspection fees, as specified. (7) Existing law prohibits a person from offering a blood or blood component product for sale unless it is produced in an establishment licensed by the Secretary of Food and Agriculture. This bill would also permit a person to offer a blood or blood component product that is in accordance with the procedures governing blood banks for animals or imported into the state from an out-of-state blood bank that the secretary would be required to track, administer, and enforce, in compliance with California standards. The bill would require that the importation and sale of canine blood and blood component products from out-of-state sources is only permitted from community blood banks and would additionally require out-of-state community blood banks that sell canine blood and blood component products in the state to submit a quarterly report to the Department of Food and Agriculture every 3 months that includes specified information. (8) Existing law requires an application for registration of blood or a blood component product to include both a protocol of the methods of production in detail that is followed in the production of the product and a sample of the label to be placed on the blood or blood component product. This bill would also require that application to include the name and address of the person who owns the property, establishment, institution, or business that sells the blood, and various other information about the products for sale and the facilities. The bill would impose a registration application fee and annual renewal fee in the amount of $500 for each blood or blood component product for retail sale or use in California. The bill would authorize the Department of Food and Agriculture to increase or decrease the fees in an amount that does not exceed the department's reasonable regulatory costs incurred to administer and enforce product safety standards. The bill would also require each licensed closed-colony blood bank to maintain an onsite record of the number of donations collected from captive animals, the amount of blood collected per donation in estimated milliliters based on weight in grams, any adverse events, and other specified information. The bill would further require a licensed closed-colony blood bank to submit quarterly reports to the department every 3 months including specified information. The bill would make a violation of this provision and other specified provisions a cause for corrective action, suspension, restriction, or the nonrenewal or revocation of a license by the department. The bill would require proceedings to be conducted in conformity with formal administrative adjudication procedures. (9) Existing law provides that all records held by the Department of Food and Agriculture relating to the provisions on commercial blood banks for animals and biologics are confidential and not subject to disclosure under the California Public Records Act, except that those records are accessible to law enforcement officers with jurisdiction over a matter covered by these provisions. This bill would provide that "identifying personal information," as defined, would be kept confidential and not subject to disclosure under the act. The bill, however, would allow for the disclosure of certain information so long as the data does not contain individually identifiable information and would require disclosure of information that is already in the public domain. The bill would define "identifying personal information" to mean certain information pertaining to the owner of an animal donor, as specified, including social security number, date of birth, and related information. (10) Existing law exempts from the provisions governing commercial blood banks for animals and biologics certain entities and also licensed private veterinarians who collect blood or blood products solely for their own practice. This bill would also exempt from those provisions licensed veterinarians engaged in the production of animal blood and blood component products for community blood banks for animals, except as specified. (11) Existing constitutional provisions require that a statute that limits the right of access to the meetings of public bodies or the writings of public officials and agencies be adopted with findings demonstrating the interest protected by the limitation and the need for protecting that interest. This bill would make legislative findings to that effect. (12) 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.