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SB-1115 Commercial blood banks for animals: animal blood donors.(2019-2020)

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Date Published: 06/18/2020 09:00 PM
SB1115:v96#DOCUMENT

Amended  IN  Senate  June 18, 2020
Amended  IN  Senate  May 20, 2020
Amended  IN  Senate  April 15, 2020

CALIFORNIA LEGISLATURE— 2019–2020 REGULAR SESSION

Senate Bill
No. 1115


Introduced by Senator Wilk
(Coauthor: Senator Caballero)

February 19, 2020


An act to amend Sections 9221 9221, 9231, and 9269 of, to amend, repeal, and add Sections 9205 and 9212 of, and to add Sections 9204.5, 9205.5, 9205.7, 9213, and 9253 to, the Food and Agricultural Code, relating to animals, and declaring the urgency thereof, to take effect immediately.


LEGISLATIVE COUNSEL'S DIGEST


SB 1115, as amended, Wilk. Commercial blood banks for animals: animal blood donors.
(1) Existing law prohibits any person from collecting blood from animals, or preparing, testing, processing, storing, or distributing blood or blood component products, as defined, from animals, for retail sale and distribution except in a commercial blood bank for animals that is licensed by the Secretary of Food and Agriculture. Existing law requires a commercial blood bank for animals, as a condition of licensing, to document how the animal donor was acquired and to have a written protocol for, among other things, ongoing veterinary care for animals held in blood donor facilities. Existing law authorizes the secretary to fix the license application fee and license renewal fee at less than, but not to exceed, $250 for each establishment. Existing law also authorizes the Department of Food and Agriculture to increase those fees to cover the department’s reasonable costs incurred in connection with required inspections. Existing law exempts all records held by the Department of Food and Agriculture department pursuant to these provisions from disclosure pursuant to the California Public Records Act.
This bill would modify the definition of a commercial blood bank for animals to limit the definition to establishments that collect blood from “community-sourced” animals, as defined, that are brought by their owners to the commercial blood bank for animals to have their blood collected. The bill would exclude from the definition of a commercial blood blank for animals establishments that collect blood from “captive closed-colony” animals that are kept, housed, or maintained for the purpose of collecting their blood. By modifying the definition of a commercial blood bank for animals in this manner, the bill would prohibit the use of captive closed-colony animals at a commercial blood bank for animals. The bill would make the modification of the definition of a commercial blood bank for animals operative 3 years after the date that the department determines that an equivalent supply of blood sold in California from captive closed-colony blood banks for animals during the years 2018 to 2019, inclusive, is being produced over an equivalent time period from community-sourced blood banks for animals. The bill would define “indirect supervision” to have the same meaning as in specified regulations and would make certain related changes.
The bill, for purposes of liability, would declare the production and use of whole blood, plasma, blood products, and blood derivatives for the purpose of injecting or transfusing the same, or any of them, into an animal to be construed to be, and would declare to be, the rendition of a service by each and every person, firm, or corporation participating, and would prohibit from being construed, and would be declared not to be, a sale of that whole blood or plasma or those blood products or blood derivatives. The bill would require a commercial blood bank for animals to include in its written protocol, which would be required to be consistent with current standards of care and practice for the field of veterinary transfusion medicine, bloodborne pathogen testing for all canine and feline blood donors, as specified.
The bill would increase the license application and license renewal fees to $1,000 and would also authorize the fees to be increased by the secretary in an amount not to exceed the reasonable regulatory costs in administering these provisions.
The bill would prohibit a commercial blood bank for animals from providing payment to a person who brings a community-sourced animal to the commercial blood bank for the purpose of donating that animal’s blood or blood component products, would impose specified requirements on a commercial blood bank for animals that accepts a donation from a community-sourced animal, would require commercial blood banks for animals to annually submit a specified report to the department and, among other enforcement actions, would subject a commercial blood bank for animals to a civil penalty of $1,000 per violation of these provisions. The bill would delete the above-described exemption from the California Public Records Act, except for identifying personal information, as defined, of owners of animal donors, as provided.
(2) 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.
(3) Under existing law, a violation of certain provisions of the Food and Agricultural Code relating to animals is a crime.
Because a violation of some of the above provisions would be a crime, 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.
(4) This bill would declare that it is to take effect immediately as an urgency statute.
Vote: 2/3   Appropriation: NO   Fiscal Committee: YES   Local Program: YES  

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


SECTION 1.

 Section 9204.5 is added to the Food and Agricultural Code, to read:

9204.5.
 “Captive closed-colony” means that an animal is kept, housed, or maintained in any way for the purpose of collecting its blood.

SEC. 2.

 Section 9205 of the Food and Agricultural Code is amended to read:

9205.
 (a) “Commercial blood bank for animals” means an establishment that produces animal blood or blood component products from captive closed-colony or community-sourced animals to market and sell for use in the cure, mitigation, treatment, or prevention of injury or disease in animals.
(b) (1) Subdivision (a) shall become inoperative three years after the date that the department determines that an equivalent supply of blood sold in California from captive closed-colony blood banks for animals during the years 2018 to 2019, inclusive, is being produced over an equivalent time period from community-sourced blood banks for animals.
(2) Upon making the determination described in paragraph (1), the department shall notify the Legislature of that determination pursuant to Section 9795 of the Government Code.
(3) This section shall be repealed on January 1 next following the date that subdivision (a) becomes inoperative pursuant to paragraph (1).

SEC. 3.

 Section 9205 is added to the Food and Agricultural Code, to read:

9205.
 (a) “Commercial blood bank for animals” means an establishment that produces animal blood or blood component products from community-sourced animals to market and sell for use in the cure, mitigation, treatment, or prevention of injury or disease in animals.
(b) This section shall become operative on the date that subdivision (a) of Section 9205, as amended by Section 2 of Senate Bill 1115 of the 2019–20 Regular Session, becomes inoperative.

SEC. 4.

 Section 9205.5 is added to the Food and Agricultural Code, to read:

9205.5.
 “Community-sourced” means that an animal is both of the following:
(a) Kept, housed, and maintained at the residence of its owner who is an individual and not a partnership, association, corporation, limited liability company, or an organized group of persons whether incorporated or not.
(b) Brought by its owner to a commercial blood bank for animals to have its blood collected.

SEC. 5.

 Section 9205.7 is added to the Food and Agricultural Code, to read:

9205.7.
 “Indirect supervision” has the same meaning as in Section 2034 of Title 16 of the California Code of Regulations.

SEC. 6.

 Section 9212 of the Food and Agricultural Code is amended to read:

9212.
 (a) The secretary shall license establishments as commercial blood banks for animals that meet all of the following:
(1) Operate under conditions, and use methods of production, that are consistent with current standards of care and practice for the field of veterinary transfusion medicine to ensure that the animal blood and blood component products will not be contaminated, dangerous, or harmful.
(2) Produce animal blood and blood component products under the supervision of either of the following:
(A) The indirect supervision of a California-licensed veterinarian.
(B) The direct supervision of a qualified person in the field for a captive closed-colony commercial blood bank for animals licensed before January 1, 2019.
(3) Maintain onsite records containing information documenting how the animal was acquired and any history of blood draws or use of anesthesia on the animal.
(b) (1) Subdivision (a) shall become inoperative three years after the date that the department determines that an equivalent supply of blood sold in California from captive closed-colony blood banks for animals during the years 2018 to 2019, inclusive, is being produced over an equivalent time period from community-sourced blood banks for animals.
(2) Upon making the determination described in paragraph (1), the department shall notify the Legislature of that determination pursuant to Section 9795 of the Government Code.
(3) This section shall be repealed on January 1 next following the date that subdivision (a) becomes inoperative pursuant to paragraph (1).

SEC. 7.

 Section 9212 is added to the Food and Agricultural Code, to read:

9212.
 (a) The secretary shall license establishments as commercial blood banks for animals that meet all of the following:
(1) Operate under conditions, and use methods of production, that are consistent with current standards of care and practice for the field of veterinary transfusion medicine to ensure that the animal blood and blood component products will not be contaminated, dangerous, or harmful.
(2) Produce animal blood and blood component products under the indirect supervision of a California-licensed veterinarian.
(3) Maintain onsite records containing information documenting how the animal was acquired and any history of blood draws or use of anesthesia on the animal.
(b) This section shall become operative on the date that subdivision (a) of Section 9212, as amended by Section 6 of Senate Bill 1115 of the 2019–20 Regular Session, becomes inoperative.

SEC. 8.

 Section 9213 is added to the Food and Agricultural Code, to read:

9213.
 For the purposes of liability pursuant to this chapter, the production and use of whole blood, plasma, blood products, and blood derivatives for the purposes of injecting or transfusing the same, or any of them, into an animal shall be construed to be, and is declared to be, the rendition of a service by each and every person, firm, or corporation participating therein, and shall not be construed to be, and is declared not to be, a sale of that whole blood or plasma or those blood products or blood derivatives.

SEC. 9.

 Section 9221 of the Food and Agricultural Code is amended to read:

9221.
 An application for a license for any establishment that produces, or proposes to produce, animal blood and blood component products shall be made on forms issued by the secretary. The application shall contain all of the following:
(a) The name and address of the person who owns the property, establishment, or institution in which it is proposed to produce animal blood and blood component products.
(b) The name and address of the person who shall oversee the production of animal blood and blood component products.
(c) The type of animal blood and blood component products to be produced.
(d) A full description of the building, including its address, facilities, equipment, and apparatus to be used in the production of animal blood and blood component products.
(e) A written protocol consistent with current standards of care and practice for the field of veterinary transfusion medicine that addresses all of the following:
(1) Minimum health parameters for animal donors.
(2) Frequency and volume of blood collected from animal donors.
(3) Socialization and exercise programs for captive closed-colony animal donors.
(4) Method of identification of each animal, including microchip or tattoo.
(5) Ongoing veterinary care, including an annual physical exam and vaccination schedule.
(6) For captive closed-colony animal donors, husbandry standards for feeding, watering, sanitation, housing, handling, and care in transit, with minimums based on the standards set forth pursuant to the federal Animal Welfare Act (7 U.S.C. Sec. 2131 et seq.) in Part 3 (commencing with Section 3.1) of Subchapter A of Chapter 1 of Title 9 of the Code of Federal Regulations.
(7) Implementation of a permissive adoption program for a captive closed-colony commercial blood bank for animals.
(8) Bloodborne pathogen testing for all canine and feline blood donors in accordance with the most recent consensus statement on blood donor infectious disease screening by the American College of Veterinary Internal Medicine.
(f) An oversight letter identifying the oversight veterinarian who will be responsible for the oversight of the facility. The letter shall be from the oversight veterinarian, and shall be maintained on file by the secretary. Oversight veterinarians shall be licensed to practice veterinary medicine in California. In the event of a change of the oversight veterinarian, it is the oversight veterinarian’s responsibility to give notice to the secretary of the termination of the oversight veterinarian within 30 days of the termination date of the oversight veterinarian. An oversight letter from the incoming oversight veterinarian shall be submitted to the secretary within 30 days of the termination date of the prior oversight veterinarian.
(g) Additional information that the secretary finds is necessary for the proper administration and enforcement of this chapter.

SEC. 10.

 Section 9231 of the Food and Agricultural Code is amended to read:

9231.
 The license application fee and license renewal fee under this chapter for an establishment proposing to produce or producing animal blood and blood component products shall be as follows:
(a) The application and annual license fee shall be two hundred fifty one thousand dollars ($250) ($1,000) for each establishment, which shall be the fee for the fiscal year, or portion thereof, ending June 30 of each year. When an applicant is a city, county, state, or district, or an official thereof, no fee shall be required under this section.
(b) Licenses shall be renewed every year. The annual renewal fee shall be paid on or before the first day of July of each year.
(c) Fees may be increased by the department to cover the but shall not exceed the department’s reasonable regulatory costs incurred in connection with performing the annual inspection required by Sections 9266 and 9268.
(d) The fees required by this section are maximum, and may be fixed increased by the secretary at a lesser amount for any fiscal year whenever he or she finds that the cost but shall not exceed the reasonable regulatory costs of administering this chapter can be defrayed from revenues derived from the lower fees. chapter.

SEC. 10.SEC. 11.

 Section 9253 is added to the Food and Agricultural Code, to read:

9253.
 (a) For purposes of this section, “payment” means the transfer by a commercial blood bank for animals licensed under this chapter to a person of money or other valuable consideration that can be converted to money by the recipient. For purposes of this section, “payment” does not include fees for veterinary tests, screenings, or services that benefit the health of the community-sourced animal from which the blood or blood component products were taken.
(b) A commercial blood bank for animals licensed under this chapter shall not provide payment to a person who brings a community-sourced animal to the commercial blood bank for the purpose of donating that animal’s blood or blood component products.
(c) A commercial blood bank for animals licensed under this chapter that accepts a donation from a community-sourced animal shall do all of the following:
(1) Obtain the informed written consent of the owner of the community-sourced animal and keep a record of that consent.
(2) Ensure that the licensed veterinarian providing indirect supervision determines that the production of blood and blood component products is safe and not injurious to the community-sourced animal’s health, including ensuring that the community-sourced animal is all of the following:
(A) An appropriate age to donate.
(B) A healthy weight to donate.
(C) Has no history of bloodborne illness.
(D) Is current on vaccinations.
(d) A commercial blood bank for animals licensed under this chapter shall maintain a record of the donations collected, the units supplied, any adverse events, and any complaints from owners regarding community-sourced animals that donate blood or blood component products.
(e) A commercial blood bank for animals licensed under this chapter shall annually report to the department all of the following:
(1) The number of donations collected and units supplied from captive closed-colonies during that year.
(2) The number of donations collected and units supplied from community-sourced animals during that year.
(3) The number of animals experiencing adverse events, the number of total adverse events, and the nature of adverse events experienced by animals that donate blood or blood component products from captive closed-colonies during that year.
(4) The number of animals experiencing adverse events and the number of total adverse events experienced by community-sourced animals that donate blood or blood component products, as well as the number and nature of complaints from owners regarding community-sourced animal donors, during that year.
(5) The number of community-sourced animal donors, and the number of captive closed-colony animal donors, whose blood tested positive for known pathogens, in accordance with the most recent consensus statement on blood donor infectious disease screening by the American College of Veterinary Internal Medicine.
(f) A violation of this section shall constitute a cause for corrective action, suspension, restriction, or the revocation of a license by the Veterinary Medical Board over those persons whom are subject to the jurisdiction of the Veterinary Medical Board. The proceedings for an enforcement action pursuant to this subdivision shall be conducted pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code.
(g) A violation of this section shall be subject to a civil penalty of one thousand dollars ($1,000) per violation and shall constitute a cause for corrective action, suspension, restriction, or the nonrenewal or revocation of a license by the department. The proceedings for an enforcement action pursuant to this subdivision shall be conducted pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code. The secretary shall have all the powers granted in that chapter.

SEC. 11.SEC. 12.

 Section 9269 of the Food and Agricultural Code is amended to read:

9269.
 (a) (1) For purposes of this section, “identifying personal information” means the following information pertaining to the owner of an animal donor that is collected for purposes of coordinating, conducting, or documenting a donation from the animal owned by that person and is maintained by the department in relation to this chapter:
(A) Social security number.
(B) Date of birth.
(C) Physical description.
(D) Home address.
(E) Home telephone number.
(F) Statements of personal worth or personal financial data.
(G) Personal medical history.
(H) Employment history.
(I) Electronic mail address.
(J) Information that reveals any electronic network location or identity.
(2) For purposes of this subdivision, a person who owns, operates, maintains, or oversees a commercial blood bank for animals shall not be considered the owner of an animal donor.
(b) Except as provided in subdivision (c), the California Public Records Act (Chapter 3.5 (commencing with Section 6250) of Division 7 of Title 1 of the Government Code) shall apply to all records held by the department relating to this chapter, including, but not limited to, records relating to applications, fees, or inspections required by this chapter.
(c) (1) Except as provided in subdivision (d) and notwithstanding subdivision (b), identifying personal information that is contained in records described in subdivision (b) shall be confidential and not subject to disclosure under the California Public Records Act (Chapter 3.5 (commencing with Section 6250) of Division 7 of Title 1 of the Government Code).
(2) Nothing in this section shall prevent the disclosure by the department of data regarding age, race, ethnicity, national origin, or gender of individuals whose personal information is protected pursuant to this section, so long as the data contains no individually identifiable information.
(d) Records held by the department relating to this chapter shall be accessible to law enforcement officers with jurisdiction over any matter covered by this chapter.

SEC. 12.SEC. 13.

 The Legislature finds and declares that Section 11 12 of this act, which amends Section 9269 of the Food and Agricultural Code, imposes a limitation on the public’s right of access to the meetings of public bodies or the writings of public officials and agencies within the meaning of Section 3 of Article I of the California Constitution. Pursuant to that constitutional provision, the Legislature makes the following findings to demonstrate the interest protected by this limitation and the need for protecting that interest:
In order to protect the privacy of owners of community-sourced animal donors and encourage their participation in animal blood donation programs, it is necessary to limit the public’s right of access to their personal information.

SEC. 13.SEC. 14.

 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.

SEC. 14.SEC. 15.

 This act is an urgency statute necessary for the immediate preservation of the public peace, health, or safety within the meaning of Article IV of the California Constitution and shall go into immediate effect. The facts constituting the necessity are:
In order to allow the Department of Food and Agriculture to license community-based commercial blood banks to meet the current animal blood shortage in the state, it is necessary that this act to take effect immediately.