CONCURRENCE IN SENATE AMENDMENTS

CSA1 Bill Id:AB 785

Author:(Bloom)

As Amended Ver:September 6, 2019

Majority vote

SUMMARY:

Revises requirements for gamete banks, particularly with respect to donor identification information.

1. For statutes addressing "tissue banks," replaces the term "gamete" with the terms "sperm, oocytes, or embryos," and includes "oocytes and embryos" under the definition of "tissue."
2. Expands the definition of identifying information of a donor to include, in addition to the donor's name and date of birth, the permanent address or other contact information, or both, given at the time of donation, or, if different, the current address or other contact information, or both, of the donor retained by the gamete bank.
3. Requires a gamete bank licensed in California that collects gametes from a donor to maintain identifying information and medical information about each gamete donor. Requires the gamete bank to maintain records of gamete screening and testing and comply with reporting requirements, in accordance with state and federal law.
4. No longer requires a gamete bank licensed in California that receives gametes from a donor collected by another gamete bank to collect and retain the donor information, but instead to collect and retain the name, address, telephone number, and email address of the gamete bank from which the gametes were received. 
5. No longer requires a gamete bank licensed in California that receives gametes from a donor to collect specified donor identifying information when the identity of the donor is known to the recipient of the gametes at the time of the donation.
6. Provides that a gamete bank licensed in this state is not required to collect gametes from a donor who does not agree to disclose the donor's identity, as provided.
7. Provides that, on request of a child conceived by assisted reproduction using donated gametes who attains 18 years of age, a gamete bank licensed in this state that received the gametes used in the assisted reproduction from another gamete bank must disclose to the child the name, address, telephone number, and email address of the gamete bank from which the gametes were received.
8. Authorizes the Department of Public Health (DPH) to issue a certificate of live birth that includes the names of unmarried genetic or intended parents who have executed a voluntary declaration of parentage, consistent with existing law, and makes the provisions gender neutral.

The Senate Amendments:

Authorize DPH to issue a certificate of live birth that includes the names of unmarried genetic or intended parents who have executed a voluntary declaration of parentage, consistent with existing law, and make the provisions gender neutral.

COMMENTS:

The Uniform Parentage Act (UPA) was passed in 1975 to extend the parent and child relationship equally to every child and to every parent, regardless of the marital status of the parents. Last year, AB 2684 (Bloom), Chapter 876, Statutes of 2018 substantially updated the UPA to provide equal treatment to children born to same-sex couples by updating terms, presumptions, and statutory provisions to ensure that parents and children are treated the same, regardless of whether their children are born into same-sex or opposite-sex couples and to update how genetic testing is performed and used to establish and challenge parentage. That bill also created a process, effective January 1, 2020, whereby children conceived with donated sperm or ova can get medical information about the donor and may, at 18 years of age if the donor agrees, receive identifying information about the donor. This bill revises that process slightly in order to comply with Food and Drug Administration requirements

According to the Author:

The updated Health and Safety codes will ensure families and donor-conceived individuals have access to their donor's medical history when gamete samples are transferred from one gamete bank to another, while complying with Federal Drug Administration's regulations.

California has taken great strides towards amending Family Codes and Health and Safety Codes to ensure current laws treat same-sex couples the same as different-sex couples. This bill continues to fill the gaps in state laws to better protect all families.

Arguments in Support:

The National Center for Lesbian Rights, the bill's co-sponsor, writes:

AB 785 is a technical cleanup of a small portion of AB 2684 (2018) relating to the release of identifying information about gamete donors to children conceived through assisted reproduction. The underlying bill was an enormous undertaking, essentially to make the Uniform Parentage Act gender neutral. Given the volume of changes and number of stakeholders, it was foreseeable that some elements might need future correction. For this reason, AB 2684 does not go into effect until January 2020. 

Since the signing of the bill, we received feedback from gamete banks that there were inconsistencies between the portions of AB 2684 addressing the release of identifying information about gamete donors and FDA requirements. The changes in AB 785 fully comply with federal requirements.

Arguments in Opposition:

None

FISCAL COMMENTS:

According to the Assembly Appropriations Committee, minor and absorbable costs to California Department of Public Health (CDPH) (Tissue Bank License Fund).

VOTES:

ASM HEALTH: 15-0-0

YES: Wood, Mayes, Aguiar-Curry, Bigelow, Bonta, Burke, Carrillo, Flora, Limón, McCarty, Nazarian, Ramos, Rodriguez, Santiago, Waldron

ASM JUDICIARY: 12-0-0

YES: Mark Stone, Gallagher, Chau, Chiu, Gonzalez, Holden, Kalra, Kiley, Maienschein, Obernolte, Petrie-Norris, Reyes

ASM APPROPRIATIONS: 18-0-0

YES: Gonzalez, Bigelow, Bloom, Bonta, Brough, Calderon, Carrillo, Chau, Diep, Eggman, Fong, Gabriel, Jones-Sawyer, Maienschein, Obernolte, Petrie-Norris, Quirk, Robert Rivas

ASSEMBLY FLOOR: 76-0-4

YES: Aguiar-Curry, Bauer-Kahan, Berman, Bigelow, Bloom, Boerner Horvath, Bonta, Brough, Burke, Calderon, Carrillo, Cervantes, Chau, Chen, Chiu, Choi, Chu, Cooley, Cooper, Cunningham, Dahle, Daly, Diep, Eggman, Flora, Fong, Frazier, Friedman, Gabriel, Gallagher, Cristina Garcia, Eduardo Garcia, Gipson, Gloria, Gonzalez, Gray, Holden, Irwin, Jones-Sawyer, Kalra, Kamlager-Dove, Kiley, Lackey, Levine, Limón, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Muratsuchi, Nazarian, O'Donnell, Obernolte, Patterson, Petrie‑Norris, Quirk-Silva, Ramos, Reyes, Luz Rivas, Robert Rivas, Rodriguez, Blanca Rubio, Salas, Santiago, Smith, Mark Stone, Ting, Voepel, Waldron, Weber, Wicks, Wood, Rendon

ABS, ABST OR NV: Arambula, Grayson, Mullin, Quirk

SENATE FLOOR: 40-0-0

YES: Allen, Archuleta, Atkins, Bates, Beall, Borgeas, Bradford, Caballero, Chang, Dahle, Dodd, Durazo, Galgiani, Glazer, Lena Gonzalez, Grove, Hertzberg, Hill, Hueso, Hurtado, Jackson, Jones, Leyva, McGuire, Mitchell, Monning, Moorlach, Morrell, Nielsen, Pan, Portantino, Roth, Rubio, Skinner, Stern, Stone, Umberg, Wieckowski, Wiener, Wilk

SENATE FLOOR: 40-0-0

YES: Allen, Archuleta, Atkins, Bates, Beall, Borgeas, Bradford, Caballero, Chang, Dahle, Dodd, Durazo, Galgiani, Glazer, Lena Gonzalez, Grove, Hertzberg, Hill, Hueso, Hurtado, Jackson, Jones, Leyva, McGuire, Mitchell, Monning, Moorlach, Morrell, Nielsen, Pan, Portantino, Roth, Rubio, Skinner, Stern, Stone, Umberg, Wieckowski, Wiener, Wilk

UPDATED:

VERSION: September 6, 2019

CONSULTANT: Leora Gershenzon / JUD. / (916) 319-2334 FN: 0002407

 THIRD READING  

Bill No: AB 785

Author: Bloom (D)

Amended: 9/6/19 in Senate

Vote: 21

SENATE HEALTH COMMITTEE: 9-0, 6/19/19

AYES: Pan, Stone, Lena Gonzalez, Grove, Hurtado, Leyva, Mitchell, Monning, Rubio

SENATE JUDICIARY COMMITTEE: 9-0, 6/25/19

AYES: Jackson, Borgeas, Durazo, Lena Gonzalez, Jones, Monning, Stern, Umberg, Wieckowski

SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8

ASSEMBLY FLOOR: 76-0, 5/2/19 (Consent) - See last page for vote

SUBJECT: Gamete banks: donor information

SOURCE: American Society for Reproductive Medicine

Equality California

National Center for Lesbian Rights

DIGEST:

This bill makes clarifying and technical changes to existing law governing gamete banks relating to the collection and disclosure of donor identifying and medical information.

Senate Floor Amendments of 9/6/19 authorizes the Department of Public Health (DPH) to issue a certificate of live birth that includes the names of unmarried same-sex parents who have executed the declaration of parentage, consistent with existing law.

ANALYSIS:

Existing law:

1. Requires every tissue bank operating in California to have a current and valid tissue bank license issued or renewed by the DPH, except as specified. Authorizes DPH to revoke or suspend the license of any tissue bank that violates licensing standards pertaining to tissue banks. [HSC §1635.1, 1639.2, 1639.3]
2. Defines “tissue bank” to mean a place, establishment, or institution that collects, processes, stores, or distributes tissue for transplantation into human beings. Defines “gamete bank” to mean a tissue bank that collects processes, or distributes gametes, including a facility that provides professional reproductive services, other than those facilities exempt from tissue bank licensure. [HSC §1635]
3. Requires gamete banks to comply with the following requirements on or after January 1, 2020. [HSC §1644.1, 1644.2, and 1664.3]
4. Requires a gamete bank to collect and retain a gamete donor’s identifying information and medical information at the time of donation. Requires a gamete bank that sends gametes to another bank to forward the donor’s identifying information, medical information, and the donor’s signed declaration regarding identity disclosure. Prohibits the sending gamete bank, once it has sent the gamete to another bank, from retaining that information. Requires the receiving gamete bank to collect and retain information about the donor and the sending gamete bank that sent the gamete.
5. Limits the responsibilities of a gamete bank that receives gametes for clinical use within one month. Limits these same gamete banks in responding to any request from a child conceived by assisted reproduction who reaches age 18 by only identifying the gamete bank that sent the donor gamete.
6. Requires a gamete bank that collects gametes from a donor to provide the donor with information about the donor’s choice regarding identity disclosure and obtain a declaration from the donor regarding identity disclosure. Requires the donor’s declaration to either agree to disclose their identity upon the request of a child conceived by assisted reproduction with the donor’s gametes, once the child reaches 18 years of age, or to decline to disclose their identity. Requires a gamete bank to authorize a donor to change their signed declaration to disclose their entity, if they previously declined to disclose.
7. Requires a gamete bank that collected, stored, or released for use the gametes used to conceive a child by assisted production to, upon the request of the child who has attained 18 years of age, provide the child with the donor’s identifying information, unless the donor signed the declaration not to disclose their identity.
8. Defines “identifying information” to mean the full name of the donor, the donor’s date of birth, and the permanent and, if different, current address of the donor at the time of donation. [HSC §1644]
9. Requires certificate of live birth issued by DPH to contain information, as specified. Requires, if the parents are not married, the father’s name not be listed unless the father and mother sign a voluntary declaration of paternity, as specified. [HSC §102425]

This bill:

1. Deletes existing law that requires gamete banks collecting donor gametes to send the donor’s identifying, medical, and identity disclosure information to a gamete bank receiving donor gametes, and instead, requires the collecting gamete bank to maintain that information.
2. Deletes existing law that requires gamete banks receiving donor gamete collect and retain information about the donor, and, instead, requires those gamete banks to collect and retain specified contact information of the gamete bank. Requires a receiving gamete bank, upon request of a child conceived by assisted reproduction who reaches age 18, to disclose the contact information of the collecting gamete bank.
3. Authorizes a gamete bank to decline to collect gametes from a donor who does not agree to disclose their identity, as specified under existing law.
4. Exempts provisions 1) to 3) from applying to gametes collected from a donor whose identity at the time of donation is known to the recipient of the gametes. Deletes existing law that limits the responsibilities of a gamete bank that receive gametes for clinical use within one month.
5. Adds “ooctyes” and “embryos” to the definition of “tissue” and “gamete banks.”
6. Requires DPH, in instances where the parents are not married, to issue a certificate of live birth that includes the name of the mother and the name of the person identified by the women giving birth as either the only possible genetic partner or the intended parent of a child conceived through assisted reproduction, who have executed the declaration of parentage, consistent with existing law.
7. Makes other technical, clarifying changes.

Comments

1. Author’s statement. According to the author, California has taken great strides towards amending Family Codes and Health and Safety Codes to ensure current laws treat same-sex couples the same as different-sex couples. This bill continues to fill the gaps in state laws to better protect all families.
2. AB 2684. AB 2684 (Bloom, Chapter 876, Statutes of 2018) made a number of changes in the Uniform Parentage Act to ensure equal treatment of same-sex couples. This included establishing in state law a process for children conceived by assisted reproductive technology to obtain identifying and medical information about the donor, with the donor’s consent, and updating an existing administrative process to allow same-sex couples to declare parentage for children born utilizing assisted reproduction. This bill makes a number of technical and clarifying changes to that statute.
3. Federal regulations. The U.S. Food and Drug Administration (FDA) regulates human cells or tissues intended for implantation, transplantation, infusion, or transfer into a human recipient. Under federal regulations, the FDA requires tissue banks that recover, process, store, and distribute human tissues to register with the FDA, comply with rules governing tissue establishments, and subject to periodic FDA inspection. The FDA has issued three rules that set requirements for the following:
   1. Tissue establishments must list their tissue products with the FDA;
   2. Tissue establishments evaluate and screen donors to reduce the transmission of infectious diseases; and,
   3. Tissue establishments must track tissue products and adhere to standard operating procedures for facilities, including records management.

The FDA’s regulations on tracking tissue products includes specific provisions on record keeping after donor-eligibility determination is complete, which intends to protect donor privacy. The regulations stipulate that once donor-eligibility has been made, the tissue must be accompanied with following information at all times:

1. A distinct identification code affixed to the container that links to the tissue’s donor and the records of that donor. The linked record, however, cannot include the donor’s name, social security number, or medical number;
2. A statement of donor eligibility; and,
3. A summary of records used to make donor eligibility, including the name and address of the tissue bank that made that determination and certification of tests and screening conducted.

In addition, FDA regulations explicitly state that records accompanying the tissue at all times must not contain the donor’s name or other personal information that might identify the donor. The prohibition on linking personal information does not apply if the donation is autologous, a directed reproductive donation, or a donation made by a first- or second-degree blood relative.

1. DPH oversight of tissue banks. DPH licenses and surveys several types of tissue facilities, including assisted reproductive technology facilities, such as sperm banks, autologous tissue storage facilities, as well as fertility clinics. However, while various types of facilities are considered tissue banks, each may interact and use the tissue for different purposes. For instance, an assisted reproductive technology facility, like a sperm bank, may collect donor tissue and send it to a fertility clinic, where the tissue will be used. FDA regulations require the sperm bank must collect relevant donor information, conduct tests on the tissue, and make a determination of donor-eligibility. When the sperm bank sends the tissue to a fertility clinic for use, certain information must follow the tissue. However, the sperm bank is generally not permitted to send the donor’s personal information to the fertility clinic along with the tissue. The sperm bank will retain the donor’s personal information along with a declaration of whether or not the donor wishes to disclose their identity. The provisions added by AB 2684, which require that donor identifying information to follow the tissue, make state law in conflict with FDA regulations.

Related/Prior Legislation

AB 2684 (Bloom, Chapter 876, Statutes of 2018) updated the UPA to: ensure equal treatment of same-sex couples; update provisions regarding genetic testing for parentage; and establish a process for children conceived from donated sperm or egg donors to receive medical information of the donor, and, if the donor agrees, identifying information.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: No

SUPPORT: (Verified 9/6/19)

American Society for Reproductive Medicine (co-source)

Equality California (co-source)

National Center for Lesbian Rights (co-source)

American Civil Liberties Union of California

OPPOSITION: (Verified 9/6/19)

None received

ARGUMENTS IN SUPPORT: This bill is co-sponsored by the National Center for Lesbian Rights and Equality California. According to the co-sponsors, this bill is a technical cleanup of a small portion of AB 2684 relating to the release of identifying information about gamete donors to children conceived through assisted reproduction. The underlying bill was an enormous undertaking, essentially to make the UPA gender neutral. Given the volume of changes and number of stakeholders, it was foreseeable that some elements might need future correction. For this reason, AB 2684 does not go into effect until January 2020. Since the signing of the bill, the sponsors received feedback from gamete banks that there were inconsistencies between the portions of AB 2684 addressing the release of identifying information about gamete donors and FDA requirements. The changes in this bill fully comply with federal requirements.

ASSEMBLY FLOOR: 76-0, 5/2/19

AYES: Aguiar-Curry, Bauer-Kahan, Berman, Bigelow, Bloom, Boerner Horvath, Bonta, Brough, Burke, Calderon, Carrillo, Cervantes, Chau, Chen, Chiu, Choi, Chu, Cooley, Cooper, Cunningham, Dahle, Daly, Diep, Eggman, Flora, Fong, Frazier, Friedman, Gabriel, Gallagher, Cristina Garcia, Eduardo Garcia, Gipson, Gloria, Gonzalez, Gray, Holden, Irwin, Jones-Sawyer, Kalra, Kamlager-Dove, Kiley, Lackey, Levine, Limón, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Muratsuchi, Nazarian, Obernolte, O'Donnell, Patterson, Petrie-Norris, Quirk-Silva, Ramos, Reyes, Luz Rivas, Robert Rivas, Rodriguez, Blanca Rubio, Salas, Santiago, Smith, Mark Stone, Ting, Voepel, Waldron, Weber, Wicks, Wood, Rendon

NO VOTE RECORDED: Arambula, Grayson, Mullin, Quirk

Prepared by: Kimberly Chen / HEALTH / (916) 651-4111

9/9/19 18:08:04

**** END ****

 THIRD READING  

Bill No: AB 785

Author: Bloom (D)

Amended: 3/27/19 in Assembly

Vote: 21

SENATE HEALTH COMMITTEE: 9-0, 6/19/19

AYES: Pan, Stone, Lena Gonzalez, Grove, Hurtado, Leyva, Mitchell, Monning, Rubio

SENATE JUDICIARY COMMITTEE: 9-0, 6/25/19

AYES: Jackson, Borgeas, Durazo, Lena Gonzalez, Jones, Monning, Stern, Umberg, Wieckowski

SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8

ASSEMBLY FLOOR: 76-0, 5/2/19 (Consent) - See last page for vote

SUBJECT: Gamete banks: donor information

SOURCE: American Society for Reproductive Medicine

Equality California

National Center for Lesbian Rights

DIGEST:

This bill makes clarifying and technical changes to existing law governing gamete banks relating to the collection and disclosure of donor identifying and medical information.

ANALYSIS:

Existing law:

1. Requires every tissue bank operating in California to have a current and valid tissue bank license issued or renewed by the Department of Public Health (DPH), except as specified. Authorizes DPH to revoke or suspend the license of any tissue bank that violates licensing standards pertaining to tissue banks. [HSC §1635.1, 1639.2, 1639.3]
2. Defines “tissue bank” to mean a place, establishment, or institution that collects, processes, stores, or distributes tissue for transplantation into human beings. Defines “gamete bank” to mean a tissue bank that collects processes, or distributes gametes, including a facility that provides professional reproductive services, other than those facilities exempt from tissue bank licensure. [HSC §1635]
3. Requires gamete banks to comply with the following requirements on or after January 1, 2020. [HSC §1644.1, 1644.2, and 1664.3]
4. Requires a gamete bank to collect and retain a gamete donor’s identifying information and medical information at the time of donation. Requires a gamete bank that sends gametes to another bank to forward the donor’s identifying information, medical information, and the donor’s signed declaration regarding identity disclosure. Prohibits the sending gamete bank, once it has sent the gamete to another bank, from retaining that information. Requires the receiving gamete bank to collect and retain information about the donor and the sending gamete bank that sent the gamete.
5. Limits the responsibilities of a gamete bank that receives gametes for clinical use within one month. Limits these same gamete banks in responding to any request from a child conceived by assisted reproduction who reaches age 18 by only identifying the gamete bank that sent the donor gamete.
6. Requires a gamete bank that collects gametes from a donor to provide the donor with information about the donor’s choice regarding identity disclosure and obtain a declaration from the donor regarding identity disclosure. Requires the donor’s declaration to either agree to disclose their identity upon the request of a child conceived by assisted reproduction with the donor’s gametes, once the child reaches 18 years of age, or to decline to disclose their identity. Requires a gamete bank to authorize a donor to change their signed declaration to disclose their entity, if they previously declined to disclose.
7. Requires a gamete bank that collected, stored, or released for use the gametes used to conceive a child by assisted production to, upon the request of the child who has attained 18 years of age, provide the child with the donor’s identifying information, unless the donor signed the declaration not to disclose their identity.
8. Defines “identifying information” to mean the full name of the donor, the donor’s date of birth, and the permanent and, if different, current address of the donor at the time of donation. [HSC §1644]

This bill:

1. Deletes existing law that requires gamete banks collecting donor gametes to send the donor’s identifying, medical, and identity disclosure information to a gamete bank receiving donor gametes, and instead, requires the collecting gamete bank to maintain that information.
2. Deletes existing law that requires gamete banks receiving donor gamete collect and retain information about the donor, and, instead, requires those gamete banks to collect and retain specified contact information of the gamete bank. Requires a receiving gamete bank, upon request of a child conceived by assisted reproduction who reaches age 18, to disclose the contact information of the collecting gamete bank.
3. Authorizes a gamete bank to decline to collect gametes from a donor who does not agree to disclose their identity, as specified under existing law.
4. Exempts provisions 1) to 3) from applying to gametes collected from a donor whose identity at the time of donation is known to the recipient of the gametes. Deletes existing law that limits the responsibilities of a gamete bank that receive gametes for clinical use within one month.
5. Adds “ooctyes” and “embryos” to the definition of “tissue” and “gamete banks.”
6. Makes other technical, clarifying changes.

Comments

1. Author’s statement. According to the author, California has taken great strides towards amending Family Codes and Health and Safety Codes to ensure current laws treat same-sex couples the same as different-sex couples. This bill continues to fill the gaps in state laws to better protect all families.
2. AB 2684. AB 2684 (Bloom, Chapter 876, Statutes of 2018) made a number of changes in the Uniform Parentage Act to ensure equal treatment of same-sex couples. This included establishing in state law a process for children conceived by assisted reproductive technology to obtain identifying and medical information about the donor, with the donor’s consent. This bill makes a number of technical and clarifying changes to that statute.
3. Federal regulations. The U.S. Food and Drug Administration (FDA) regulates human cells or tissues intended for implantation, transplantation, infusion, or transfer into a human recipient. Under federal regulations, the FDA requires tissue banks that recover, process, store, and distribute human tissues to register with the FDA, comply with rules governing tissue establishments, and subject to periodic FDA inspection. The FDA has issued three rules that set requirements for the following:
   1. Tissue establishments must list their tissue products with the FDA;
   2. Tissue establishments evaluate and screen donors to reduce the transmission of infectious diseases; and,
   3. Tissue establishments must track tissue products and adhere to standard operating procedures for facilities, including records management.

The FDA’s regulations on tracking tissue products includes specific provisions on record keeping after donor-eligibility determination is complete, which intends to protect donor privacy. The regulations stipulate that once donor-eligibility has been made, the tissue must be accompanied with following information at all times:

1. A distinct identification code affixed to the container that links to the tissue’s donor and the records of that donor. The linked record, however, cannot include the donor’s name, social security number, or medical number;
2. A statement of donor eligibility; and,
3. A summary of records used to make donor eligibility, including the name and address of the tissue bank that made that determination and certification of tests and screening conducted.

In addition, FDA regulations explicitly state that records accompanying the tissue at all times must not contain the donor’s name or other personal information that might identify the donor. The prohibition on linking personal information does not apply if the donation is autologous, a directed reproductive donation, or a donation made by a first- or second-degree blood relative.

1. DPH oversight of tissue banks. DPH licenses and surveys several types of tissue facilities, including assisted reproductive technology facilities, such as sperm banks, autologous tissue storage facilities, as well as fertility clinics. However, while various types of facilities are considered tissue banks, each may interact and use the tissue for different purposes. For instance, an assisted reproductive technology facility, like a sperm bank, may collect donor tissue and send it to a fertility clinic, where the tissue will be used. FDA regulations require the sperm bank must collect relevant donor information, conduct tests on the tissue, and make a determination of donor-eligibility. When the sperm bank sends the tissue to a fertility clinic for use, certain information must follow the tissue. However, the sperm bank is generally not permitted to send the donor’s personal information to the fertility clinic along with the tissue. The sperm bank will retain the donor’s personal information along with a declaration of whether or not the donor wishes to disclose their identity. The provisions added by AB 2684, which require that donor identifying information to follow the tissue, make state law in conflict with FDA regulations.

Related/Prior Legislation

AB 2684 (Bloom, Chapter 876, Statutes of 2018) updated the UPA to: ensure equal treatment of same-sex couples; update provisions regarding genetic testing for parentage; and establish a process for children conceived from donated sperm or egg donors to receive medical information of the donor, and, if the donor agrees, identifying information.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: No

SUPPORT: (Verified 7/8/19)

American Society for Reproductive Medicine (co-source)

Equality California (co-source)

National Center for Lesbian Rights (co-source)

American Civil Liberties Union of California

OPPOSITION: (Verified 7/8/19)

None received

ARGUMENTS IN SUPPORT: This bill is co-sponsored by the National Center for Lesbian Rights and Equality California. According to the co-sponsors, this bill is a technical cleanup of a small portion of AB 2684 relating to the release of identifying information about gamete donors to children conceived through assisted reproduction. The underlying bill was an enormous undertaking, essentially to make the UPA gender neutral. Given the volume of changes and number of stakeholders, it was foreseeable that some elements might need future correction. For this reason, AB 2684 does not go into effect until January 2020. Since the signing of the bill, the sponsors received feedback from gamete banks that there were inconsistencies between the portions of AB 2684 addressing the release of identifying information about gamete donors and FDA requirements. The changes in this bill fully comply with federal requirements.

ASSEMBLY FLOOR: 76-0, 5/2/19

AYES: Aguiar-Curry, Bauer-Kahan, Berman, Bigelow, Bloom, Boerner Horvath, Bonta, Brough, Burke, Calderon, Carrillo, Cervantes, Chau, Chen, Chiu, Choi, Chu, Cooley, Cooper, Cunningham, Dahle, Daly, Diep, Eggman, Flora, Fong, Frazier, Friedman, Gabriel, Gallagher, Cristina Garcia, Eduardo Garcia, Gipson, Gloria, Gonzalez, Gray, Holden, Irwin, Jones-Sawyer, Kalra, Kamlager-Dove, Kiley, Lackey, Levine, Limón, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Muratsuchi, Nazarian, Obernolte, O'Donnell, Patterson, Petrie-Norris, Quirk-Silva, Ramos, Reyes, Luz Rivas, Robert Rivas, Rodriguez, Blanca Rubio, Salas, Santiago, Smith, Mark Stone, Ting, Voepel, Waldron, Weber, Wicks, Wood, Rendon

NO VOTE RECORDED: Arambula, Grayson, Mullin, Quirk

Prepared by: Kimberly Chen / HEALTH / (916) 651-4111

7/10/19 14:47:12

**** END ****

SENATE JUDICIARY COMMITTEE

Senator Hannah-Beth Jackson, Chair

2019-2020 Regular Session

Bill No: AB 785 (Author:Bloom)

Version: March 27, 2019

Hearing Date: June 25, 2019

Fiscal: Yes

Urgency: No

Consultant: JT

SUBJECT

Gamete banks: donor information

DIGEST

This bill, to align state statutes with federal regulations, changes the manner of gathering, keeping, and disclosing gamete donor medical and identifying information.

EXECUTIVE SUMMARY

To ensure consistency with federal Food and Drug Administration (FDA) regulations, this bill alters existing provisions that govern how children conceived by donated gametes—eggs or sperm—may obtain the medical and identifying information of the donor.

First, the bill provides that gamete banks need not collect gametes of donors who refuse to disclose their identifying information. Second, the bill deletes the requirement that a gamete bank that sends gametes to another bank also send the donor’s identifying and medical information; instead, the bill requires the sending bank to retain that information and the recipient bank to collect and retain the contact information of the sending bank. Upon turning 18, the child conceived by assisted reproduction using donor gametes may request that the bank that supplied the gametes furnish the information of the bank from which it received the gametes. Finally, the bill exempts from these requirements gametes collected from a donor whose identity is known to the recipient of the gametes at the time of the donation.

The bill is co-sponsored by the American Society for Reproductive Medicine, Equality California, and the National Center for Lesbian Rights and is supported by the American Civil Liberties Union. It has no known opposition. The bill passed the Senate Health Committee by a vote of 9-0.

PROPOSED CHANGES TO THE LAW

Existing law:

1. Requires gamete banks, beginning January 1, 2020, with regard to identifying and medical information of donors, to:
   1. obtain and send the information to other gamete banks as follows:
      1. collect and retain the information at the time of donation;
      2. if it sends gametes to another bank, include the information, after which the sending bank is no longer required to keep the information;
      3. requires the recipient bank to collect and retain the information (Health & Saf. Code § 1644.1);
   2. determine whether the donor consents to the disclosure of the information as follows:
      1. provide the donor with information about the donor’s choice to disclose;
      2. obtain from the donor a declaration either agreeing or not agreeing to disclose the donor’s identity to the child at 18 years of age;
      3. enable the donor to override the decision to not disclose the information (Health & Saf. Code § 1644.2);
   3. provide the information to the child as follows:
      1. provide the donor’s identifying information on request of the child, unless the donor did not override the decision to withhold their information, in which case the gamete bank must make a good faith effort to notify the donor that the donor may still disclose their information to the child; and
      2. provide the donor’s non-identifying medical information to the child on request (Health & Saf. Code § 1644.3).

This bill:

1. Requires a gamete bank to collect and maintain, in addition to the identifying information and medical information described above, any other contact information provided by the donor at the time of the donation and records of gamete screening and testing.
2. Deletes the requirement that a gamete bank that sends gametes to another bank also send the donor’s identifying and medical information and instead requires the sending bank to retain that information and the recipient bank to collect and retain the contact information of the sending bank.
3. Specifies that a gamete bank is not required to collect gametes from a donor who does not agree to disclose their identity.
4. Requires a gamete bank that receives gametes collected by another gamete bank to collect and retain contact information for the gamete bank from which the gametes were received, and to disclose that information to a child that results from the donation, after the child turns 18 years of age and requests the information.
5. Exempts from these requirements gametes collected from a donor whose identity is known to the recipient of the gametes at the time of the donation.

COMMENTS

1. Background

The Uniform Parentage Act (UPA) (Fam. Code § 7600 et seq.) was part of a package of legislation introduced in 1975 (SB 347, Beilenson, Ch. 1244, Stats. 1975) to eliminate the legal distinction between legitimate and illegitimate children. The UPA instead focuses on the “parent and child relationship,” defined as “the legal relationship existing between a child and his natural or adoptive parents incident to which the law confers or imposes rights, privileges, duties, and obligations. It includes the mother and child relationship and the father and child relationship.” (Fam. Code § 7601.) The law further provides that “the parent and child relationship extends equally to every child and to every parent, regardless of the marital status of the parents.” (Fam. Code § 7602.) AB 1403 (Committee on Judiciary, Ch. 510, Stats. 2013) made technical and clarifying changes to the UPA to codify case law, and made the Act’s provisions gender-neutral where appropriate.

Last session, AB 2684 (Bloom, Ch. 876, Stats. 2018) updated and revised the UPA by:

• updating terms, presumptions, and statutory provisions to ensure that parents and children are treated the same, regardless of whether the children are born to same-sex or opposite-sex couples;
• updating how genetic testing is performed and used to establish and challenge parentage; and
• creating a process whereby children conceived with donated sperm or ova can get medical information about the donor, and, at 18 years of age and with the agreement of the donor, receive identifying information about the donor.

The provisions this bill would amend were also added by AB 2684—specifically, a requirement that gamete banks, beginning January 1, 2020, with regard to identifying and medical information of donors, do all of the following:

• collect and retain the information at the time of donation;
• obtain from the donor a declaration either agreeing or not agreeing to disclose the donor’s identity to the child at 18 years of age;
• enable the donor to override the decision to not disclose the information;
• provide the donor’s identifying information on request of the child, unless the donor did not override the decision to withhold their information, in which case the gamete bank must make a good faith effort to notify the donor that the donor may still disclose their information to the child; and
• provide the donor’s non-identifying medical information to the child on request.

2. Aligns provisions governing gamete donor information with federal law

The FDA regulates establishments, or “banks,” that process, store, and distribute donated gametes. Under FDA regulations, donors must be screened for certain communicable diseases and their medical records must be reviewed to ascertain risk factors. Records regarding the donor’s medical eligibility must be retained by the processing establishment, and must additionally accompany the donated gametes. (See 21 C.F.R. § 1271.55(a), (d).) However, FDA regulations provide that “[t]he accompanying records … must not contain the donor's name or other personal information that might identify the donor.” (Id. at (c).)

As discussed above, AB 2684 was intended to provide a means by which a child conceived through the use of donated gametes may acquire the identifying information of the donor, if the donor so consents. These provisions run afoul of FDA regulations, however, because they require the donor’s identifying information to accompany the gametes when they are sent to a new gamete bank.

The main purpose of this bill is to eliminate this conflict. Co-sponsors American Society for Reproductive Medicine, Equality California, and National Center for Lesbian Rights write:

AB 785 is a technical cleanup of AB 2684 (2018) relative to gamete donor identity information for assisted reproductive technologies. The underlying bill was an enormous undertaking, essentially to make the Uniform Parentage Act gender neutral. Given the volume of changes, it was foreseeable that some elements might need future correction, hence a one year delay in the implementation of the law.

Since the signing of the bill, feedback from gamete (sperm, oocyte, embryo) banks was that there were inconsistencies between AB 2684 and FDA requirements specific to donor identity for gametes of donors unknown to the parties attempting to achieve a pregnancy. The changes in AB 785 should better synchronize with federal requirements.

To accomplish this objective, the bill alters how identifying and medical information of donors is gathered, kept, and disclosed. First, the bill provides that gamete banks need not collect gametes of donors who refuse to disclose their identifying information. Second, the bill deletes the requirement that a gamete bank that sends gametes to another bank also send the donor’s identifying and medical information, and instead requires the sending bank to retain that information and the recipient bank to collect and retain the contact information of the sending bank. Upon turning 18, the child conceived by assisted reproduction using donor gametes may request that the bank that supplied the gametes furnish the information of the bank from which it received the gametes. Finally, the bill exempts from these requirements gametes collected from a donor whose identity is known to the recipient of the gametes at the time of the donation. These changes effectively align California’s statutes with federal law.

According to the author: “California has taken great strides towards amending Family Codes and Health and Safety Codes to ensure current laws treat same-sex couples the same as different-sex couples. AB 785 continues to fill the gaps in state laws to better protect all families.”

SUPPORT

American Society for Reproductive Medicine (co-sponsor)

Equality California (co-sponsor)
National Center for Lesbian Rights (co-sponsor)

American Civil Liberties Union

OPPOSITION

None known

RELATED LEGISLATION

Pending Legislation: None known

Prior Legislation: See Comment 1.

PRIOR VOTES:

Senate Health Committee (Ayes 9, Noes 0)

Assembly Floor (Ayes 76, Noes 0)

Assembly Appropriations Committee (Ayes 18, Noes 0)

Assembly Judiciary Committee (Ayes 12, Noes 0)

Assembly Health Committee (Ayes 15, Noes 0)

**************

SENATE COMMITTEE ON HEALTH

Senator Dr. Richard Pan, Chair

BILL NO: AB 785

SUBJECT: Gamete banks: donor information

SUMMARY:

Makes clarifying and technical changes to existing law governing gamete banks relating to the collection and disclosure of donor identifying and medical information.

Existing state law:

1. Requires every tissue bank operating in California to have a current and valid tissue bank license issued or renewed by the Department of Public Health (DPH), except as specified. Authorizes DPH to revoke or suspend the license of any tissue bank that violates licensing standards pertaining to tissue banks. [HSC §1635.1, 1639.2, 1639.3]
2. Defines “tissue bank” to mean a place, establishment, or institution that collects, processes, stores, or distributes tissue for transplantation into human beings. Defines “gamete bank” to mean a tissue bank that collects processes, or distributes gametes, including a facility that provides professional reproductive services, other than those facilities exempt from tissue bank licensure. [HSC §1635]
3. Requires gamete banks to comply with the following requirements on or after January 1, 2020. [HSC §1644.1, 1644.2, and 1664.3]
4. Requires a gamete bank to collect and retain a gamete donor’s identifying information and medical information at the time of donation. Requires a gamete bank that sends gametes to another bank to forward the donor’s identifying information, medical information, and the donor’s signed declaration regarding identity disclosure. Prohibits the sending gamete bank, once it has sent the gamete to another bank, from retaining that information. Requires the receiving gamete bank to collect and retain information about the donor and the sending gamete bank that sent the gamete.
5. Limits the responsibilities of a gamete bank that receives gametes for clinical use within one month. Limits these same gamete banks in responding to any request from a child conceived by assisted reproduction who reaches age 18 by only identifying the gamete bank that sent the donor gamete.
6. Requires a gamete bank that collects gametes from a donor to provide the donor with information about the donor’s choice regarding identity disclosure and obtain a declaration from the donor regarding identity disclosure. Requires the donor’s declaration to either agree to disclose their identity upon the request of a child conceived by assisted reproduction with the donor’s gametes, once the child reaches 18 years of age, or to decline to disclose their identity. Requires a gamete bank to authorize a donor to change their signed declaration to disclose their entity, if they previously declined to disclose.
7. Requires a gamete bank that collected, stored, or released for use the gametes used to conceive a child by assisted production to, upon the request of the child who has attained 18 years of age, provide the child with the donor’s identifying information, unless the donor signed the declaration not to disclose their identity.
8. Defines “identifying information” to mean the full name of the donor, the donor’s date of birth, and the permanent and, if different, current address of the donor at the time of donation. [HSC §1644]

This bill:

1. Deletes existing law that requires gamete banks collecting donor gametes to send the donor’s identifying, medical, and identity disclosure information to a gamete bank receiving donor gametes, and instead, requires the collecting gamete bank to maintain that information.
2. Deletes existing law that requires gamete banks receiving donor gamete collect and retain information about the donor, and, instead, requires those gamete banks to collect and retain specified contact information of the gamete bank. Requires a receiving gamete bank, upon request of a child conceived by assisted reproduction who reaches age 18, to disclose the contact information of the collecting gamete bank.
3. Authorizes a gamete bank to decline to collect gametes from a donor who does not agree to disclose their identity, as specified under existing law.
4. Exempts provisions 1) to 4) from applying to gametes collected from a donor whose identity at the time of donation is known to the recipient of the gametes. Deletes existing law that limits the responsibilities of a gamete bank that receive gametes for clinical use within one month.
5. Adds “ooctyes” and “embryos” to the definition of “tissue” and “gamete banks.”
6. Makes other technical, clarifying changes.

FISCAL EFFECT:

According to Assembly Appropriations Committee, minor and absorbable costs to DPH (Tissue Bank License Fund).

COMMENTS:

1. Author’s statement. According to the author, California has taken great strides towards amending Family Codes and Health and Safety Codes to ensure current laws treat same-sex couples the same as different-sex couples. This bill continues to fill the gaps in state laws to better protect all families.
2. AB 2684. AB 2684 (Bloom, Chapter 876, Statutes of 2018) made a number of changes in the Uniform Parentage Act (UPA) to ensure equal treatment of same-sex couples. This included establishing in state law a process for children conceived by assisted reproductive technology to obtain identifying and medical information about the donor, with the donor’s consent. This bill makes a number of technical and clarifying changes to that statute.
3. Federal regulations. The U.S. Food and Drug Administration (FDA) regulates human cells or tissues intended for implantation, transplantation, infusion, or transfer into a human recipient. Under federal regulations, the FDA requires tissue banks that recover, process, store, and distribute human tissues to register with the FDA, comply with rules governing tissue establishments, and subject to periodic FDA inspection. The FDA has issued three rules that set requirements for the following:
   1. Tissue establishments must list their tissue products with the FDA;
   2. Tissue establishments evaluate and screen donors to reduce the transmission of infectious diseases; and,
   3. Tissue establishments must track tissue products and adhere to standard operating procedures for facilities, including records management.

The FDA’s regulations on tracking tissue products includes specific provisions on record keeping after donor-eligibility determination is complete, which intends to protect donor privacy. The regulations stipulate that once donor-eligibility has been made, the tissue must be accompanied with following information at all times:

1. A distinct identification code affixed to the container that links to the tissue’s donor and the records of that donor. The linked record, however, cannot include the donor’s name, social security number, or medical number;
2. A statement of donor eligibility; and,
3. A summary of records used to make donor eligibility, including the name and address of the tissue bank that made that determination and certification of tests and screening conducted.

In addition, FDA regulations explicitly state that records accompanying the tissue at all times must not contain the donor’s name or other personal information that might identify the donor. The prohibition on linking personal information does not apply if the donation is autologous, a directed reproductive donation, or a donation made by a first- or second-degree blood relative.

1. DPH oversight of tissue banks. DPH licenses and surveys several types of tissue facilities, including assisted reproductive technology facilities, such as sperm banks, autologous tissue storage facilities, as well as fertility clinics. However, while various types of facilities are considered tissue banks, each may interact and use the tissue for different purposes. For instance, an assisted reproductive technology facility, like a sperm bank, may collect donor tissue and send it to a fertility clinic, where the tissue will be used. FDA regulations require the sperm bank must collect relevant donor information, conduct tests on the tissue, and make a determination of donor-eligibility. When the sperm bank sends the tissue to a fertility clinic for use, certain information must follow the tissue. However, the sperm bank is generally not permitted to send the donor’s personal information to the fertility clinic along with the tissue. The sperm bank will retain the donor’s personal information along with a declaration of whether or not the donor wishes to disclose their identity. The provisions added by AB 2684, which require that donor identifying information to follow the tissue, make state law in conflict with FDA regulations.
2. Double referral. This bill is double referred. Should it pass out of this committee, it will be referred to the Senate Judiciary Committee.
3. Prior legislation. AB 2684 (Bloom, Chapter 876, Statutes of 2018) updated the UPA to: ensure equal treatment of same-sex couples; update provisions regarding genetic testing for parentage; and establish a process for children conceived from donated sperm or egg donors to receive medical information of the donor, and, if the donor agrees, identifying information.
4. Support. This bill is co-sponsored by the National Center for Lesbian Rights and Equality California. According to the co-sponsors, this bill is a technical cleanup of a small portion of AB 2684 relating to the release of identifying information about gamete donors to children conceived through assisted reproduction. The underlying bill was an enormous undertaking, essentially to make the UPA gender neutral. Given the volume of changes and number of stakeholders, it was foreseeable that some elements might need future correction. For this reason, AB 2684 does not go into effect until January 2020. Since the signing of the bill, the sponsors received feedback from gamete banks that there were inconsistencies between the portions of AB 2684 addressing the release of identifying information about gamete donors and FDA requirements. The changes in this bill fully comply with federal requirements.

SUPPORT AND OPPOSITION:

Support: Equality California (co-sponsor)

National Center for Lesbian Rights (co-sponsor)

American Civil Liberties Union of California

American Society for Reproductive Medicine

Oppose: None received

-- END --

Date of Hearing: April 24, 2019

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Lorena Gonzalez, Chair

ABPCA Bill Id:AB 785

Author:(Bloom) – As Amended Ver:March 27, 2019

Urgency: No State Mandated Local Program: No Reimbursable: No

SUMMARY:

This bill makes minor and clarifying changes to statutes governing gamete banks (tissue banks that handle reproductive cells), regarding the transfer of identifying information from one bank to another and disclosure of medical and identifying information of donors.

FISCAL EFFECT:

Minor and absorbable costs to California Department of Public Health (CDPH) (Tissue Bank License Fund).

COMMENTS:

1. Purpose. The author states this bill will ensure a family and a donor-conceived individual has access to their donor’s medical history when gamete samples are transferred from one gamete bank to another, while complying with federal regulations. This bill is co-sponsored by the National Center for Lesbian Rights and Equality California and has no opposition.
2. Background. Gametes are mature sexual reproductive cells, such as a sperm or an egg, capable of uniting with another cell to form a new organism. Gamete banks are regulated as tissue banks by CDPH.

The Uniform Parentage Act (UPA) was passed in 1975 to extend the parent and child relationship equally to every child and to every parent, regardless of the marital status of the parents. Last year, the author’s AB 2684, Chapter 876, Statutes of 2018, updated the UPA to provide equal treatment to children born to same-sex couples. That bill also created a process, effective January 1, 2020, whereby children conceived with donated sperm or egg can get medical information about the donor and may, at 18 years of age if the donor agrees, receive identifying information about the donor.

The sponsors note gamete banks expressed concern there were inconsistencies between the portions of AB 2684 addressing the release of identifying information about gamete donors and U.S. Food and Drug Administration requirements. This bill revises that process slightly in order to comply with these requirements.

Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081

Date of Hearing: April 9, 2019

ASSEMBLY COMMITTEE ON JUDICIARY

Mark Stone, Chair

ABPCA Bill Id:AB 785

Author:(Bloom) – As Amended Ver:March 27, 2019

SUBJECT: Gamete banks: donor information

KEY ISSUE: should minor CHANGES be made to the rules for acceptance by Gamete banks of sperm, egg, or embryo donation, primarily regarding medical INFORMATION from, and identification of, donors?

SYNOPSIS

The Uniform Parentage Act (UPA) was passed in 1975 to extend the parent and child relationship equally to every child and to every parent, regardless of the marital status of the parents. Last year, the author’s AB 2684, Chap. 876, substantially updated the UPA to provide equal treatment to children born to same-sex couples by updating terms, presumptions, and statutory provisions to ensure that parents and children are treated the same, regardless of whether the children are born into same-sex or opposite-sex couples and to update how genetic testing is performed and used to establish and challenge parentage. That bill also created a process, effective January 1, 2020, whereby children conceived with donated sperm or ova can get medical information about the donor and may, at 18 years of age if the donor agrees, receive identifying information about the donor. This bill revises that process slightly in order to comply with Food and Drug Administration requirements. The author states that this bill “will ensure families and donor-conceived individuals have access to their donor’s medical history when gamete samples are transferred from one gamete bank to another, while complying with Federal Drug Administration’s regulations.” This bill is co-sponsored by the National Center for Lesbian Rights and Equality California and has no reported opposition. It passed the Assembly Health Committee last week on a vote of 15-0.

SUMMARY: Revises requirements for gamete banks, particularly with respect to donor identification information. Specifically, this bill:

1. For statutes addressing “tissue banks,” replaces the term “gamete” with the terms “sperm, oocytes, or embryos,” and includes “oocytes and embryos” under the definition of “tissue.”
2. Expands the definition of identifying information of a donor to include, in addition to the donor’s name and date of birth, the permanent address or other contact information, or both, given at the time of donation, or, if different, the current address or other contact information, or both, of the donor retained by the gamete bank.
3. Requires a gamete bank licensed in California that collects gametes from a donor to maintain identifying information and medical information about each gamete donor. Requires the gamete bank to maintain records of gamete screening and testing and comply with reporting requirements, in accordance with state and federal law.
4. No longer requires a gamete bank licensed in California that receives gametes from a donor collected by another gamete bank to collect and retain the donor information, but instead to collect and retain the name, address, telephone number, and email address of the gamete bank from which the gametes were received. 
5. No longer requires a gamete bank licensed in California that receives gametes from a donor to collect specified donor identifying information when the identity of the donor is known to the recipient of the gametes at the time of the donation.
6. Provides that a gamete bank licensed in this state is not required to collect gametes from a donor who does not agree to disclose the donor’s identity, as provided.
7. Provides that, on request of a child conceived by assisted reproduction using donated gametes who attains 18 years of age, a gamete bank licensed in this state that received the gametes used in the assisted reproduction from another gamete bank must disclose to the child the name, address, telephone number, and email address of the gamete bank from which the gametes were received.

EXISTING LAW:

1. Establishes the California Uniform Parentage Act (UPA). Defines a parent and child relationship as the legal relationship existing between a child and the child’s natural or adoptive parents incident to which the law confers or imposes rights, privileges, duties, and obligations. (Family Code Section 7600 et seq.)
2. Provides that if a woman conceives through assisted reproduction with semen or ova donated by a donor not her spouse, with the consent of another intended parent, that intended parent is treated in law as the child's natural parent. (Family Code Section 7613.)
3. Requires every tissue bank operating in California to have a current and valid tissue bank license issued or renewed by the Department of Public Health. Defines a “tissue bank” as a place, establishment, or institution that collects, processes, stores, or distributes tissue for transplantation into human beings. Defines a “gamete bank” as a tissue bank that collects, processes, stores, or distributes gametes, including a facility that provides professional reproductive services, other than those facilities that are exempt. (Health and Safety Code Sections 1635-1635.1.)
4. Requires, beginning January 1, 2020, a gamete bank, providing reproductive services to collect and retain identifying and medical information, as defined, from a donor at the time of the donation. Requires the gamete bank to obtain from the donor a declaration either agreeing or not agreeing to disclose the donor's identity to the child at 18 years of age. Allows donors who initially decide to keep their identifying information confidential to change their mind. Allows the child at 18 to receive identifying information from a donor who agreed to the release of information. Requires the gamete bank to provide the child, or the child's parent or guardian if the child is a minor, with nonidentifying medical information about the donor. (Health and Safety Code Sections 1644.1-1644.3.)
5. Establishes, under federal law, the Health Insurance Portability and Accountability Act of 1996 (HIPAA), which sets standards for privacy of individually identifiable health information. Provides that if HIPAA’s provisions conflict with state law, the provision that is most protective of patient privacy prevails. (Pub.L. 104–191, 110 Stat. 1936.)
6. Prohibits, under the state Confidentiality of Medical Information Act, a provider of health care, a health care service plan, a contractor, a corporation and its subsidiaries and affiliates, or any business that offers software or hardware to consumers from intentionally sharing, selling, using for marketing, or otherwise using any medical information, as defined, for any purpose not necessary to provide health care services to a patient, except as expressly authorized by the patient, enrollee, or subscriber, as specified, or as otherwise required or authorized by law. (Civil Code Section 56 et seq.)

FISCAL EFFECT: As currently in print this bill is keyed fiscal.

COMMENTS: The UPA was passed in 1975 to extend the parent and child relationship equally to every child and to every parent, regardless of the marital status of the parents. Last year, AB 2684 (Bloom), Chap. 876, substantially updated the UPA to provide equal treatment to children born to same-sex couples by updating terms, presumptions, and statutory provisions to ensure that parents and children are treated the same, regardless of whether their children are born into same-sex or opposite-sex couples and to update how genetic testing is performed and used to establish and challenge parentage. That bill also created a process, effective January 1, 2020, whereby children conceived with donated sperm or ova can get medical information about the donor and may, at 18 years of age if the donor agrees, receive identifying information about the donor. This bill revises that process slightly in order to comply with Food and Drug Administration requirements.

In support of the bill, the author states:

The updated Health and Safety codes will ensure families and donor-conceived individuals have access to their donor’s medical history when gamete samples are transferred from one gamete bank to another, while complying with Federal Drug Administration’s regulations.

California has taken great strides towards amending Family Codes and Health and Safety Codes to ensure current laws treat same-sex couples the same as different-sex couples. AB 785 continues to fill the gaps in state laws to better protect all families.

Last year’s AB 2684 significantly updated the UPA. AB 2684 (Bloom) made significant changes to the UPA. In particular, that bill expanded the voluntary declaration of paternity beyond natural mothers and the men identified as the natural fathers by the mothers, to include, beginning January 1, 2020, any person identified as a parent by the woman who gave birth to the child, including a genetic parent and an intended parent using assisted reproduction, as provided. That bill also expanded the presumption that children of married spouses are conclusively presumed, except as provided, to be children of the marriage, to include children of same-sex couples and revised how challenges to that presumption may be made. The bill updated the genetic testing scheme with up-to-date scientific material on genetic matching.

Of particular relevance to this bill, AB 2684 created new requirements for gamete banks to better inform parents and children conceived using the assisted reproduction about medical information and identifying information from the donor. Under that bill, beginning January 1, 2020, a gamete bank that provides reproductive services in California must collect and maintain various identifying and medical information from a donor at the time of the donation. The bank must also obtain from the donor a declaration either agreeing or not agreeing to disclose the donor’s identity to the child at 18 years or age. If the donor initially decides to keep their identifying information confidential, the donor can change their mind, but if the donor agrees to release identifying information, that decision cannot be changed. At 18 years of age, the child conceived as a result of the donation may, if the person so chooses, receive identifying information from a donor who agreed to the release of that information. Nonidentifying medical information is accessible immediately by the child, or the child’s parent or guardian if the child is a minor.

This bill makes minor changes to the rules surrounding donor identity and gamete banks. All gamete banks must be registered with the Food and Drug Administration (FDA) and follow specific requirements. (21 CFR Part 1271.) There are some minor inconsistencies between FDA regulations and the changes enacted in last year’s AB 2684, and this bill seeks to make minor changes in state statutes to ensure that gamete banks licensed in California can fully comply with federal requirements.

In particular, this bill no longer requires that a gamete bank licensed in California and receiving gametes from another bank to also receive donor identifying information. Instead the gamete receiving bank must simply receive and maintain contact information for the gamete collecting bank and provide that information to the parents or now-adult child conceived with the gametes. The parents or now-adult child can then go to the original gamete collecting bank to get medical and identifying information on the donor information, as provided. The bill also specifically does not require that a gamete bank collect information from a donor who is known to the recipient of the gametes at the time of the donation. Nor is the bank, under the bill, required to collect gametes from a donor who does not agree to disclose the donor’s identity, as provided. Finally, this bill revises some definitions and expands the definition of donor identifying information to help ensure that a gamete bank has the best contact information for a donor. These provisions, while all fairly minor, ensure that California gamete banks can comply with both California law and FDA requirements.

ARGUMENTS IN SUPPORT: The National Center for Lesbian Rights, the bill’s co-sponsor, writes:

AB 785 is a technical cleanup of a small portion of AB 2684 (2018) relating to the release of identifying information about gamete donors to children conceived through assisted reproduction. The underlying bill was an enormous undertaking, essentially to make the Uniform Parentage Act gender neutral. Given the volume of changes and number of stakeholders, it was foreseeable that some elements might need future correction. For this reason, AB 2684 does not go into effect until January 2020. 

Since the signing of the bill, we received feedback from gamete banks that there were inconsistencies between the portions of AB 2684 addressing the release of identifying information about gamete donors and FDA requirements. The changes in AB 785 fully comply with federal requirements. 

REGISTERED SUPPORT / OPPOSITION:

Support

Equality California (co-sponsor)

National Center for Lesbian Rights (co-sponsor)

American Society for Reproductive Medicine

Opposition

None on file

Analysis Prepared by: Leora Gershenzon / JUD. / (916) 319-2334

Date of Hearing: April 2, 2019

ASSEMBLY COMMITTEE ON HEALTH

Jim Wood, Chair

ABPCA Bill Id:AB 785

Author:Bloom – As Amended Ver:March 27, 2019

SUBJECT: Gamete banks: donor information.

SUMMARY: Requires a gamete bank to collect and maintain, in addition to the identifying information and medical information, as specified, any other contact information provided by the donor at the time of the donation and records of gamete screening and testing. Requires a gamete bank that receives gametes collected by another gamete bank to collect and retain contact information for the gamete bank from which the gametes were received, and to disclose that information to a child that results from the donation, upon the child turning 18 years of age and requesting the information. Exempts from these requirements gametes collected from a donor whose identity is known to the recipient of the gametes at the time of the donation. Specifically, this bill:

1. Revises the existing definition of gamete bank in existing law to include a tissue bank that collects, processes, stores, or distributes sperm, oocytes, or embryos.
2. Defines tissue to include oocytes and embryos; and, identifying information to include the permanent address or other contact information, or both, given at the time of donation, or, if different, the current address or other contact information, or both, of the donor retained by the gamete bank. 
3. Requires a licensed gamete bank to collect, and retain from a gamete donor, the donor’s identifying information and medical information at the time of the donation. Requires a licensed gamete bank that receives gametes from a donor collected by another gamete bank, to collect and retain the name, address, telephone number, and email address of the gamete bank from which the gametes were received. 
4. Requires a licensed gamete bank to disclose the information collected, as specified.
5. Deletes requirements for a gamete bank obtaining gametes for the purpose of clinical utilization within one month from receipt to be considered a receiving gamete bank responsible for long term retention of any identifying information or medical information, as specified.
6. Revises existing law to require a licensed gamete bank that collects gametes from a donor to also maintain identifying information and medical information about each gamete donor. Requires the gamete bank to maintain records of gamete screening and testing and to comply with reporting requirements, in accordance with federal law and applicable state law.
7. Revises existing law to require a licensed gamete bank to permit a donor who has signed a declaration that the donor does not agree to disclose the donor’s identity, to withdraw the declaration at any time by signing a declaration that the donor agrees to disclose the donor’s identity, as specified.
8. Specifies that a licensed gamete bank is not required to collect gametes from a donor who does not agree to disclose the donor’s identity, as specified.
9. Requires a licensed gamete bank that received the gametes used in the assisted reproduction from another gamete bank to disclose the name, address, telephone number, and email address of the gamete bank from which the gametes were received, on the request of a child conceived by assisted reproduction using donor gametes who attains 18 years of age.
10. Excludes from the provisions of this bill, gametes collected from a donor whose identity is known to the recipient of the gametes at the time of the donation. 
11. Makes technical and clarifying changes.

EXISTING LAW:

1. Establishes the Department of Public Health to license and regulate gamete banks.
2. Requires a licensed gamete bank, for gametes collected on or after January 1, 2020, to collect certain identifying information and medical information from a gamete donor, including the donor’s full name, date of birth, and address.
3. Requires a gamete bank to obtain a declaration from the gamete donor stating whether the donor agrees to disclose the donor’s identity to a child that results from the donation, upon the child turning 18 years of age and requesting the information.
4. Defines the following:
   1. Donor as an individual, living or deceased, from whom tissue is removed.
   2. Gamete bank as a tissue bank that collects, processes, stores, or distributes gametes including a facility that provides professional reproductive services, other than those facilities exempt from tissue bank licensure.
   3. Person as an individual, corporation, business trust, estate trust, partnership, association, state or local government, or subdivision or agency thereof, or any other legal entity.
   4. Tissue as a human cell, group of cells, including the cornea, sclera, or vitreous humor and other segments of, or the whole eye, bones, skin, arteries, sperm, blood, other fluids, and any other portion of a human body, but shall not include an organ when recovered for transplantation or research purposes.
   5. Identifying information as the full name of the donor, the donor’s date of birth, and the permanent and, if different, current address at the time of donation.
5. Establishes under federal law, the Health Insurance Portability and Accountability Act of 1996 (HIPAA) which sets standards for privacy of individually identifiable health information and security standards for the protection of electronic protected health information, including, through regulations, that a HIPAA covered entity may not condition the provision of treatment, payment, enrollment in the health plan, or eligibility for benefits on the provision of an authorization, except under specified circumstances. Provides that if HIPAA’s provisions conflict with state law, the provision that is most protective of patient privacy prevails.
6. Prohibits, under the state Confidentiality of Medical Information Act, a provider of health care, a health care service plan, a contractor, a corporation and its subsidiaries and affiliates, or any business that offers software or hardware to consumers, including a mobile application or other related device, as defined, from intentionally sharing, selling, using for marketing, or otherwise using any medical information, as defined, for any purpose not necessary to provide health care services to a patient, except as expressly authorized by the patient, enrollee, or subscriber, as specified, or as otherwise required or authorized by law. States that a violation of these provisions that results in economic loss or personal injury to a patient is a crime.

FISCAL EFFECT: This bill has not yet been analyzed by a fiscal committee.

COMMENTS:

1. PURPOSE OF THIS BILL. According to the author, California has taken great strides towards amending existing law to ensure current laws treat same-sex couples the same as different-sex couples. This bill continues to fill the gaps in state laws to better protect all families.
2. BACKGROUND. AB 2684 (Bloom), Chapter 876, Statutes of 2018, updates and revises the Uniform Parentage Act relating to establishing a parent and child relationship to, among other things, refer instead to genetic testing and parentage. AB 2684 also revises the presumptions and procedures for establishing and challenging parentage based on a genetic or nongenetic relationship with a child, including to modify the procedures for genetic testing for parentage. AB 2684 also modifies the procedures and requirements under which a voluntary declaration of parentage may be established and challenged.

AB 2684 also defines gamete bank as a tissue bank that collects, processes, stores, or distributes gametes, including a facility that provides reproductive services and requires a licensed gamete bank to collect specified identifying information and medical information, as defined, from a gamete donor, to provide the gamete donor with specified information, and, to obtain a declaration from the gamete donor regarding the disclosure or nondisclosure of his or her identity to a child that results from the donation, upon the child turning 18 years of age and requesting the information.

According to the author, this bill updates existing law to streamline the transition of donor information from one bank to another by requiring gamete banks receiving donors’ gametes to maintain the contact information of the gamete bank from which the samples were received and to include oocyte and embryo donors. These updates will ensure families and donor-conceived individuals have access to their donor’s medical history when gamete samples are transferred from one gamete bank to another, while complying with Federal Drug Administration’s (FDA) regulations.

1. FDA regulations. Donated reproductive tissue (eggs or sperm) are regulated as human cells, tissues, and cellular and tissue-based products.  Any establishment that performs one or more manufacturing steps for tissue-based products (recovery, processing, storage, labeling, packaging or distribution of products) must register with the FDA and list their tissue-based products in accordance with existing federal regulations.
2. SUPPORT. The American Society for Reproductive Medicine and the National Center for Lesbian Rights, the cosponsors of this bill, write that this bill is a technical cleanup of AB 2684 relative to gamete donor identity information for assisted reproductive technologies. AB 2684 was an enormous undertaking, essentially to make the Uniform Parentage Act gender neutral. Since the signing of AB 2684, feedback from gamete (sperm, oocyte, and embryo) banks was that there were inconsistencies between AB 2684 and FDA requirements specific to donor identity for gametes of donors unknown to the parties attempting to achieve a pregnancy. The changes in this bill should better synchronize with federal requirements.
3. PREVIOUS LEGISLATION. AB 2684 Bloom, Chapter 876, Statutes of 2018, updates and revises the Uniform Parentage Act relating to establishing a parent and child relationship to, among other things, refer instead to genetic testing and parentage. AB 2684 also defines gamete bank as a tissue bank that collects, processes, stores, or distributes gametes, including a facility that provides reproductive services and requires a licensed gamete bank to collect specified identifying information and medical information, as defined, from a gamete donor, to provide the gamete donor with specified information, and, to obtain a declaration from the gamete donor regarding the disclosure or nondisclosure of his or her identity to a child that results from the donation, upon the child turning 18 years of age and requesting the information.
4. DOUBLE REFERRAL. This bill is double referred; upon passage it this Committee, this bill will be referred to the Assembly Judiciary Committee.

REGISTERED SUPPORT / OPPOSITION:

Support

American Society for Reproductive Medicine (cosponsor)
National Center for Lesbian Rights (cosponsor)

Opposition

None on file.

Analysis Prepared by: Kristene Mapile / Rosielyn Pulmano / HEALTH / (916) 319-2097