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AB-366 Animals: blood, blood components, and biologics. (2019-2020)



Current Version: 03/21/19 - Amended Assembly        


AB366:v98#DOCUMENT

Revised  March 25, 2019
Amended  IN  Assembly  March 21, 2019

CALIFORNIA LEGISLATURE— 2019–2020 REGULAR SESSION

Assembly Bill No. 366


Introduced by Assembly Member Bloom
(Coauthors: Assembly Members Carrillo, O’Donnell, Petrie-Norris, and Waldron)
(Coauthors: Senators Hertzberg, Hill, and Wiener)

February 04, 2019


An act to add Article 7 (commencing with Section 4920) to Chapter 11 of Division 2 of the Business and Professions Code, and to amend, repeal, and add Section 9202 of Section 9210 of, the Food and Agriculture Agricultural Code, relating to animal health.


LEGISLATIVE COUNSEL'S DIGEST


AB 366, as amended, Bloom. Animals: blood, blood components, and biologics.
Existing law, the Veterinary Medicine Practice Act, provides for the licensure and regulation of veterinary medicine by the Veterinary Medical Board in the Department of Consumer Affairs. Existing law authorizes the Veterinary Medical Board to deny, revoke, or suspend a license or registration or assess a fine for a violation of specified acts, including the employment of anyone but a veterinarian licensed in this state to demonstrate the use of biologics in the treatment of animals. A violation of the act is a crime.
Existing law prohibits 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 licensed by the secretary and requires the Secretary of Food and Agriculture and requires the secretary to license commercial blood banks for animals that meet specified requirements. Existing law prohibits a person from engaging in the production of biologics except as permitted under federal law. Existing law exempts licensed private veterinarians who collect blood or blood products solely for use in their own practice from these provisions regulating and licensing commercial blood banks for animals and biologics. A violation of the act is a crime. Existing law defines animal, for the purposes of these provisions, as any domesticated fowl or nonhuman mammal and any wild fowl, bird, or mammal that is reduced to captivity. A violation of these provisions is a crime.

This bill, beginning on January 1, 2022, would change the definition of “animal,” for the purposes of the provisions related to commercial blood banks for animals, to exclude dogs and cats.

This bill, beginning on not withstanding any law, commencing January 1, 2022, would authorize a licensed veterinarian to engage in the production of dog and cat prohibit a person from engaging in the production of canine blood and blood component products or biologics if specified conditions are met, including consent, safety, and record keeping requirements. This bill would otherwise prohibit any person from engaging in the production of dog and cat blood and blood component products or biologics. By for retail sale and distribution unless that person is licensed as a canine blood bank by the Secretary of Food and Agriculture, among other specified requirements, including the requirement that the operations are performed under the direct supervision of a licensed veterinarian or board-certified specialist. The bill would prohibit a canine blood bank from paying a person for canine blood or blood component products and would require a canine blood bank to keep specified records.
By expanding the scope of an existing crime with regard to violations of the Veterinary Medical Practice Act, existing crimes, this bill would impose a state-mandated local program.
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.
Vote: MAJORITY   Appropriation: NO   Fiscal Committee: YES   Local Program: YES  

The people of the State of California do enact as follows:


SECTION 1.

 Article 7 (commencing with Section 4920) is added to Chapter 11 of Division 2 of the Business and Professions Code, to read:
Article  7. Production of Blood, Blood Component Products, and Biologics

4920.
 (a)For the purposes of this article:

(1)

(a) “Biologics” has the same meaning as defined in Section 9203 of the Food and Agriculture Agricultural Code.

(2)

(b) “Blood and blood component products” has the same meaning as defined in Section 9204 of the Food and Agriculture Agricultural Code.
(c) “Canine blood bank” means an establishment that produces canine whole blood and blood component products.
(d) “Donor colony” means a commercial blood bank for animals licensed by the Secretary of Food and Agriculture pursuant to Section 9212 of the Food and Agricultural Code that engages in the production of blood or blood component products for sale and distribution.

(3)

(e) “Production” has the same meaning as defined in Section 9206 of the Food and Agriculture Agricultural Code.

(b)Notwithstanding any other law, a licensed veterinarian may engage in the production of dog and cat blood and blood component products or biologics if all of the following conditions are met:

(1)The licensed veterinarian obtains written consent from the owner of the dog or cat involved in the collection of blood and blood component products.

(2)The

4920.2
 (a) A person may engage in the production of canine blood or blood component products for sale from canines held in captivity as part of a donor colony only until January 1, 2022.
(b) Notwithstanding any law, commencing January 1, 2022, a person shall not engage in the production of canine blood or blood component products for retail sale and distribution unless the person is licensed by the Secretary of Food and Agriculture as a canine blood bank, and both of the following conditions are met:
(1) The canine blood bank collects blood only from a canine whose owner is a member of the public who voluntarily consents to the donation.
(2) The operations are performed under the direct supervision of a licensed veterinarian or board-certified specialist.
(c) To the extent possible, the canine blood bank shall follow the 31st edition of the American Association of Blood Banks’ standards, and the veterinarian or specialist of the canine blood bank shall be responsible for all veterinary and technical policies and procedures that relate to the safety of staff members and donors, including, but not limited to, ensuring that the canine blood bank has a qualified and competent staff to perform all tasks involved in the collection, storage, processing, and distribution of blood and blood component products.
(d) The canine blood bank shall at all times do all of the following:
(1) Follow the American College of Veterinary Internal Medicine Consensus Statement on blood donor infectious disease screening as published in the Journal of Veterinary Internal Medicine in 2016 or in later published editions.
(2) Ensure that the donor canine:
(A) Is at least one year of age.
(B) Weighs at least 50 pounds.
(C) Possesses a good temperament.
(D) Is current on vaccinations.
(E) Has no prior history of bloodborne illness.
(3) Obtain written consent from the donor’s owner.
(4) Ensure that the licensed veterinarian has determined determines that the production of blood and blood component products or biologics is safe and noninjurious not injurious to the dog or cat’s dog’s health.

(3)The production of blood and blood component products or biologics is performed using methods of production to ensure

(5) Ensure that the dog or cat blood and blood component products will not be contaminated, dangerous, or harmful.

(4)The licensed veterinarian maintains records containing information documenting how the dog or cat was acquired and any history of blood draws or use of anesthesia on the dog or cat.

(5)The

(6) Ensure that the production of blood and blood component products or biologics complies with any applicable federal laws and regulations, including Section 151 and following of Title 21 of the United States Code.

(c)

(e) A violation of this section shall constitute a cause for discipline by the board pursuant to Section 4875.

(d)Except as provided in subdivision (b), a person shall not engage in the production of dog and cat blood and blood component products or biologics.

(e)This section shall become operative on January 1, 2022.

4920.3.
 (a) It shall be unlawful for a canine blood bank licensed pursuant to Section 9210 of the Food and Agricultural Code to provide payment to a person for canine blood or blood component products.
(b) For the purposes of this section, “payment” means the transfer by a canine blood bank to a person of money or other valuable consideration that can be converted to money by the recipient. For the purposes of this section, “payment” does not include fees for veterinary tests, screenings, or services that benefit the health of the canine from which the blood or blood component products was taken.
(c) The canine blood bank shall maintain a record of the donations collected, units supplied, any adverse events, and any consumer complaints. This information shall be gathered by the licensed veterinarian and submitted to the board for inclusion in the report required pursuant to Section 9147.7 of the Government Code.
(d) This section shall become operative January 1, 2022.

4920.5.
 (a) An application for a canine blood bank license or canine blood bank license renewal shall be accompanied by a fee, payable to the Secretary of Food and Agriculture, of one thousand dollars ($1,000).
(b) The application and renewal fees for canine blood bank licenses pursuant to subdivision (a) shall be adjusted annually for inflation. The adjustments shall be rounded off to the nearest whole dollar.
(c) This section shall become operative January 1, 2022.

SEC. 2.Section 9202 of the Food and Agricultural Code is amended to read:
9202.

(a)“Animal” includes, but is not limited to, any domesticated fowl or nonhuman mammal and any wild fowl, bird, or mammal that is reduced to captivity.

(b)This section is repealed as of January 1, 2022.

SEC. 3.Section 9202 is added to the Food and Agricultural Code, to read:
9202.

(a)“Animal” includes any domesticated fowl or nonhuman mammal and any wild fowl, bird, or mammal that is reduced to captivity, but does not include dogs or cats.

(b)This section shall become operative on January 1, 2022.

SEC. 2.

 Section 9210 of the Food and Agricultural Code is amended to read:

9210.
 No person shall (a) A person shall not engage 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.
(b) Notwithstanding subdivision (a), commencing January 1, 2022, a person shall not engage in the production of canine blood and blood component products for retail sale and distribution except in a canine blood bank licensed by the secretary.

SEC. 4.SEC. 3.

 No reimbursement is required by this act pursuant to Section 6 of Article XIII B of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIII B of the California Constitution.
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REVISIONS:
Heading—Line 2.
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