California Animal Blood Banks Program
As a result of increased specialization in veterinary medicine, the demand for animal blood products has risen dramatically. A safe and adequate supply of blood and blood component products for transfusion is vital to animal health. Commercial blood banks for animals produce and sell blood and blood component products, increasing the supply available for transfusions. The CDFA Animal Blood Banks program defines current standards of care and practice for veterinary blood banks and works to ensure that animal blood and blood component products sold in California are efficacious and safe.
Historically, California required commercial blood banks for animals to be closed-colony establishments. On January 1, 2022, Assembly Bill 1282, the California Pet Blood Bank Modernization Act, went into effect. This law aims to address the shortage of animal blood available for veterinary transfusion medicine in California and transition the state from closed-colony blood banks to community blood banks.
California Food and Agricultural Code (FAC) Division 5, Chapter 1.5 (Commercial Blood Banks for Animals and Biologics) and California Business and Professions Code (BPC) Division 2, Chapter 11, Article 7 (Community Blood Banks for Animals) are the State’s legal authority for enforcing state law and regulations pertinent to animal blood banks.
Announcements
- December 20, 2024: The Department of Food and Agriculture (Department), Animal Blood Bank Program, is proposing to further modify the originally proposed text for the California Code of Regulations Title 3, Division 2, Chapter 8 heading, and new Articles 1 – 4 (commencing with section 1303) pertaining to Animal Blood Bank requirements as described in the California Regulatory Notice Register on February 2, 2024, Register 2024, No. 5–Z, Notice File Number Z2024-0123-02. A copy of the third modified text can be found below.
- July 1, 2024: The Department of Food and Agriculture (Department), Animal Blood Bank Program, is proposing to further modify the originally proposed text for the California Code of Regulations Title 3, Division 2, Chapter 8 heading, and new Articles 1 – 4 (commencing with section 1303) pertaining to Animal Blood Bank requirements as described in the California Regulatory Notice Register on February 2, 2024, Register 2024, No. 5–Z, Notice File Number Z2024-0123-02. The text of the regulation with the proposed modifications can be found below.
- June 6, 2024: The California Department of Food and Agriculture (Department), Animal Blood Bank Program, is proposing to modify the originally proposed text for the California Code of Regulations Title 3, Division 2, Chapter 8 heading, and new Articles 1 – 4 (commencing with section 1303) pertaining to Animal Blood Bank requirements as described in the California Regulatory Notice Register on February 2, 2024, Register 2024, No. 5–Z, Notice File Number Z2024-0123-02. Only those portions of the originally proposed text that are indicated by a double underline or double strikethrough have been modified. The remainder of the text is the same as the originally proposed text. The text of the regulation with the proposed modifications can be found below. The following documents added to the rulemaking file pursuant to Government Code sections 11346.8(d), 11346.9(a)(1) and 11347.1: Addendum to the Initial Statement of Reasons, February 2024 California Consumer Price Index, Animal Blood Bank Program Expenses and Revenue 2024/25, and Economic and Fiscal Impact Statement (STD 399), The documents pertain to the regulatory action as described above (Notice File Number Z2024-0123-02). The Addendum to the Initial Statement of Reasons is added to this proposal to provide a summary of the text, as modified, and adding updated fiscal information. A copy of the documents added to the rulemaking file can be found below.
- March 12, 2024: The California Department of Food and Agriculture published a Notice of Proposed Rulemaking to amend the California Code of Regulations (CCR) Title 3, Division 2, Chapter 8 heading, and adopt new Articles 1-4 (commencing with section 1303) in the California Regulatory Notice Register on February 2, 2024. The proposal aims to implement, interpret, and make specific the laws related to animal blood banks. The notice initiated a public comment period that was scheduled from February 2, 2024, to March 18, 2024. The Department hereby extends the public comment period for an additional 14 days. The public comment period will now close on Monday, April 1, 2024.
- January 23, 2024: The California Department of Food and Agriculture proposes to amend the California Code of Regulations (CCR) Title 3, Division 2, Chapter 8 heading, and adopt new Articles 1 - 4 (commencing with section 1303) to implement, interpret, and make specific the laws related to animal blood banks. The public comment period begins February 2, 2024 and ends on March 18, 2024. Any interested person, or his or her duly authorized representative, may submit written comments relevant to the proposed regulatory action to the Department according to the instructions contained in the Notice posted in the documents below.
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February 27, 2023: The Animal Blood Banking Guidance Document is now available. The document was created in conjunction with the Veterinary Medical Board, technical experts, and stakeholders. It is designed to give veterinarians clear, accurate, and concise information regarding best management practices for operating animal blood banks. It includes information in all the following areas:
- Animal donor qualification, selection, and screening
- Bloodborne pathogen testing
- Safe blood products handling, processing, labeling, and storage
- January 1, 2022: Importation and sale of canine blood and blood component products from out-of-state sources shall only be permitted from community blood banks (FAC 9252 (b)). CDFA will discontinue its licensing program for commercial blood banks for animals that produce canine blood and blood component products sourced from captive closed-colony dogs within 18 months of making a finding that community blood banks sold an annual amount of canine blood in California that equals or exceeds the annual amount closed-colony blood banks sold in four consecutive quarters. This will be announced on this website.
- Association of Veterinary Hematology and Transfusion Medicine (AVHTM)
- Association for the Advancement of Blood & Biotherapies
- Association for the Advancement of Blood and Biotherapies - Standards for Blood Banks and Transfusion Services
- Association for the Advancement of Blood and Biotherapies - Technical Manual
- Food and Drug Administration Center for Veterinary Medicine GFI #254 Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products
- Food and Drug Administration Center for Veterinary Medicine GFI #218 Cell-Based Products for Animal Use
- California Veterinary Medical Board
- California Veterinary Medical Association Blood Banking Information
- Abrams-Ogg, A.C.G. and Blois, S.L. (2022). Principles of Canine and Feline Blood Collection, Processing, and Storage. In Schalm's Veterinary Hematology (eds M.B. Brooks, K.E. Harr, D.M. Seelig, K.J. Wardrop and D.J. Weiss)
- Yagi K, Holowaychuk MK. Manual of Veterinary Transfusion Medicine and Blood Banking. Ames, IA: Wiley Blackwell; 2016.
- Wardrop KJ, Birkenheuer A, Blais MC, et al. Update on Canine and Feline Blood Donor Screening for Blood-Borne Pathogens. J Vet Intern Med. 2016;30(1):15-35. doi:10.1111/jvim.13823
- Taylor S, Spada E, Callan MB, et al. 2021 ISFM Consensus Guidelines on the Collection and Administration of Blood and Blood Products in Cats. J Feline Med Surg. 2021;23(5):410-432. doi:10.1177/1098612X211007071
- Davidow EB, Blois SL, Goy-Thollot I, et al. Association of Veterinary Hematology and Transfusion Medicine (AVHTM) Transfusion Reaction Small Animal Consensus Statement (TRACS). Part 1: Definitions and clinical signs. J Vet Emerg Crit Care (San Antonio). 2021;31(2):141-166. doi:10.1111/vec.13044
- Davidow EB, Blois SL, Goy-Thollot I, et al. Association of Veterinary Hematology and Transfusion Medicine (AVHTM) Transfusion Reaction Small Animal Consensus Statement (TRACS) Part 2: Prevention and monitoring. J Vet Emerg Crit Care (San Antonio). 2021;31(2):167-188. doi:10.1111/vec.13045
- Odunayo A, Nash KJ, Davidow EB, et al. Association of Veterinary Hematology and Transfusion Medicine (AVHTM) transfusion reaction small animal consensus statement (TRACS). Part 3: Diagnosis and treatment. J Vet Emerg Crit Care (San Antonio). 2021;31(2):189-203. doi:10.1111/vec.13043
Links
Contact Information
The Animal Blood Banks program can be mailed at:
CDFA Animal Health and Food Safety Services
Attn: Dr. Sean Brady
1220 N Street
Sacramento, CA 95814
Submit electronic correspondence to CDFAbloodbanks@cdfa.ca.gov