This measure would call upon the President of the United States to encourage the Secretary of the United States Department of Health and Human Services to adopt policies to repeal the current discriminatory donor suitability policies of the United States Food and Drug Administration (FDA) regarding blood donations by men who have had sex with another man and, instead, direct the FDA to develop science-based policies such as criteria based on risky behavior in lieu of sexual orientation.

This measure would call upon the President of the United States to encourage the Secretary of the United States Department of Health and Human Services to adopt policies to repeal the current discriminatory donor suitability policies of the United States Food and Drug Administration (FDA) regarding blood donations by men who have had sex with another man and, instead, direct the FDA to develop science-based policies such as criteria based on risky behavior in lieu of sexual orientation.

This measure would call upon the President of the United States to encourage the Secretary of the United States Department of Health and Human Services to adopt policies to repeal the current discriminatory donor suitability policies of the United States Food and Drug Administration (FDA) regarding blood donations by men who have had sex with another man and, instead, direct the FDA to develop science-based policies such as criteria based on risky behavior in lieu of sexual orientation.

This measure would call upon the President of the United States to encourage the Secretary of the United States Department of Health and Human Services to adopt policies to repeal the current discriminatory donor suitability policies of the United States Food and Drug Administration (FDA) regarding blood donations by men who have had sex with another man and, instead, direct the FDA to develop science-based policies such as criteria based on risky behavior in lieu of sexual orientation.

This measure would call upon the President of the United States to encourage the Secretary of the United States Department of Health and Human Services to adopt policies to repeal the current discriminatory donor suitability policies of the United States Food and Drug Administration (FDA) regarding blood donations by men who have had sex with another man and, instead, direct the FDA to develop science-based policies such as criteria based on risky behavior in lieu of sexual orientation.

WHEREAS, Since 1983, the United States Food and Drug Administration (FDA), an agency under the United States Department of Health and Human Services (HHS), had prohibited the donation of blood by any man who has had sex with another man (MSM) at any time since 1977; and

WHEREAS, In December 2015, based on recommendations from the HHS Advisory Committee on Blood and Tissue Safety and Availability, the FDA promulgated revised regulations to allow an MSM to donate blood only if he has not been sexually active for the past 12 months. Despite these recent steps toward a policy change, a double standard still exists under the policy as revised because it still treats gay and bisexual men differently from heterosexual men; and

WHEREAS, California law prohibits discrimination against individuals on the basis of actual or perceived sex, sexual orientation, gender identity, and gender-related appearance and behavior; and

WHEREAS, Argentina, Italy, Mexico, Poland, Portugal, Russia, South Africa, South Korea, and Spain have adopted blood donor policies that measure risk against a set of behaviors, sexual and otherwise, rather than the sex of a persons sexual partner or partners; and

WHEREAS, The FDA currently does not allow gay and bisexual men in committed relationships to donate blood because, while one partner may be monogamous, that individual cannot guarantee that the other partner is monogamous. The FDA does not apply this same logic to heterosexual relationships, which in effect discriminates against gay and bisexual men; and

WHEREAS, The FDA is in the process of again reevaluating and considering updating its blood donor deferral policies as new scientific information becomes available, including the feasibility of moving from the existing time-based deferrals related to risk behaviors to alternate deferral options, such as the use of individual risk assessments; and

WHEREAS, A 12-month deferral policy for gay and bisexual men to donate blood is overly stringent given the scientific evidence, advanced testing methods, and the safety and quality control measures in place within the different FDA-qualified blood donating centers; and

WHEREAS, The American Public Health Association has stated that no specific scientific rationale is provided to justify the 12-month deferral policy. The technology can identify within 7 to 10 days with 99.9 percent accuracy whether or not a blood sample is HIV-positive, and the chance of the blood test being inaccurate within the 10-day window is about 1 in 2,000,000; and

WHEREAS, The General Social Survey conducted by NORC at the University of Chicago estimates that 8.5 percent of men in the United States have had at least one male sex partner since 18 years of age, 4.1 percent of men report at least one male sex partner in the last 5 years, and 3.8 percent report a male sex partner in the last 12 months; and

WHEREAS, An estimated 45.4 percent of men (54 million) in the United States are eligible to donate blood, but only 8.7 percent of eligible men actually do. There are 15.7 million donations of blood per year made by 9.2 million donors, yielding approximately 1.7 donations per donor; and

WHEREAS, The Williams Institute of the University of California at Los Angeles School of Law estimates that, based on the population of eligible and likely donors among the MSM community, lifting the federal lifetime deferral policy on blood donation by an MSM would result in 4.2 million newly eligible male donors, of which 360,600 would likely donate, generating 615,300 additional pints of blood. Applying national estimates to the California population, the Institute further estimates that lifting the ban on MSM blood donations would add an additional 510,000 eligible men to the current blood donor pool, of which 43,917 would likely donate, resulting in an additional 74,945 donated pints in California; and

WHEREAS, One hundred fifteen members of the Congress of the United States sent a letter to the FDA Commissioner, Dr. Robert M. Califf, M.D., urging him to finally put an end to this outdated blood donation policy and update it to reflect science, not fear; now, therefore, be it

Resolved by the Senate and the Assembly of the State of California, jointly, That the California State Legislature calls upon the President of the United States to encourage the Secretary of the United States Department of Health and Human Services to adopt policies to repeal the current discriminatory donor suitability policies of the United States Food and Drug Administration (FDA) regarding blood donations by men who have had sex with another man and, instead, direct the FDA to develop science-based policies such as criteria based on risky behavior in lieu of sexual orientation; and be it further

Resolved, That the Secretary of the Senate transmit copies of this resolution to the President and Vice President of the United States, to the Secretary of the United States Department of Health and Human Services, to the Speaker of the House of Representatives, to the Majority Leader of the Senate, and to each Senator and Representative from California in the Congress of the United States.

WHEREAS, Since 1983, the United States Food and Drug Administration (FDA), an agency under the United States Department of Health and Human Services (HHS), had prohibited the donation of blood by any man who has had sex with another man (MSM) at any time since 1977; and

WHEREAS, In December 2015, based on recommendations from the HHS Advisory Committee on Blood and Tissue Safety and Availability, the FDA promulgated revised regulations to allow an MSM to donate blood only if he has not been sexually active for the past 12 months. Despite these recent steps toward a policy change, a double standard still exists under the policy as revised because it still treats gay and bisexual men differently from heterosexual men; and

WHEREAS, California law prohibits discrimination against individuals on the basis of actual or perceived sex, sexual orientation, gender identity, and gender-related appearance and behavior; and

WHEREAS, Argentina, Italy, Mexico, Poland, Portugal, Russia, South Africa, South Korea, and Spain have adopted blood donor policies that measure risk against a set of behaviors, sexual and otherwise, rather than the sex of a persons sexual partner or partners; and

WHEREAS, The FDA currently does not allow gay and bisexual men in committed relationships to donate blood because, while one partner may be monogamous, that individual cannot guarantee that the other partner is monogamous. The FDA does not apply this same logic to heterosexual relationships, which in effect discriminates against gay and bisexual men; and

WHEREAS, The FDA is in the process of again reevaluating and considering updating its blood donor deferral policies as new scientific information becomes available, including the feasibility of moving from the existing time-based deferrals related to risk behaviors to alternate deferral options, such as the use of individual risk assessments; and

WHEREAS, A 12-month deferral policy for gay and bisexual men to donate blood is overly stringent given the scientific evidence, advanced testing methods, and the safety and quality control measures in place within the different FDA-qualified blood donating centers; and

WHEREAS, The American Public Health Association has stated that no specific scientific rationale is provided to justify the 12-month deferral policy. The technology can identify within 7 to 10 days with 99.9 percent accuracy whether or not a blood sample is HIV-positive, and the chance of the blood test being inaccurate within the 10-day window is about 1 in 2,000,000; and

WHEREAS, The General Social Survey conducted by NORC at the University of Chicago estimates that 8.5 percent of men in the United States have had at least one male sex partner since 18 years of age, 4.1 percent of men report at least one male sex partner in the last 5 years, and 3.8 percent report a male sex partner in the last 12 months; and

WHEREAS, An estimated 45.4 percent of men (54 million) in the United States are eligible to donate blood, but only 8.7 percent of eligible men actually do. There are 15.7 million donations of blood per year made by 9.2 million donors, yielding approximately 1.7 donations per donor; and

WHEREAS, The Williams Institute of the University of California at Los Angeles School of Law estimates that, based on the population of eligible and likely donors among the MSM community, lifting the federal lifetime deferral policy on blood donation by an MSM would result in 4.2 million newly eligible male donors, of which 360,600 would likely donate, generating 615,300 additional pints of blood. Applying national estimates to the California population, the Institute further estimates that lifting the ban on MSM blood donations would add an additional 510,000 eligible men to the current blood donor pool, of which 43,917 would likely donate, resulting in an additional 74,945 donated pints in California; and

WHEREAS, One hundred fifteen members of the Congress of the United States sent a letter to the FDA Commissioner, Dr. Robert M. Califf, M.D., urging him to finally put an end to this outdated blood donation policy and update it to reflect science, not fear; now, therefore, be it

Resolved by the Senate and the Assembly of the State of California, jointly, That the California State Legislature calls upon the President of the United States to encourage the Secretary of the United States Department of Health and Human Services to adopt policies to repeal the current discriminatory donor suitability policies of the United States Food and Drug Administration (FDA) regarding blood donations by men who have had sex with another man and, instead, direct the FDA to develop science-based policies such as criteria based on risky behavior in lieu of sexual orientation; and be it further

Resolved, That the Secretary of the Senate transmit copies of this resolution to the President and Vice President of the United States, to the Secretary of the United States Department of Health and Human Services, to the Speaker of the House of Representatives, to the Majority Leader of the Senate, and to each Senator and Representative from California in the Congress of the United States.

WHEREAS, Since 1983, the United States Food and Drug Administration (FDA), an agency under the United States Department of Health and Human Services (HHS), had prohibited the donation of blood by any man who has had sex with another man (MSM) at any time since 1977; and

WHEREAS, In December 2015, based on recommendations from the HHS Advisory Committee on Blood and Tissue Safety and Availability, the FDA promulgated revised regulations to allow an MSM to donate blood only if he has not been sexually active for the past 12 months. Despite these recent steps toward a policy change, a double standard would still exist still exists under the policy as it is proposed to be revised because it would still treat still treats gay and bisexual men differently from heterosexual men; and

WHEREAS, California law prohibits discrimination against individuals on the basis of actual or perceived sex, sexual orientation, gender identity, and gender-related appearance and behavior; and

WHEREAS, Argentina, Italy, Mexico, Poland, Portugal, Russia, South Africa, South Korea, and Spain have adopted blood donor policies that measure risk against a set of behaviors, sexual and otherwise, rather than the sex of a persons sexual partner or partners; and

WHEREAS, The FDA currently does not allow gay and bisexual men in committed relationships to donate blood because, while one partner may be monogamous, that individual cannot guarantee that the other partner is monogamous. The FDA does not apply this same logic to heterosexual relationships, which in effect discriminates against gay and bisexual men; and

WHEREAS, The FDA is in the process of again reevaluating and considering updating its blood donor deferral policies as new scientific information becomes available, including the feasibility of moving from the existing time-based deferrals related to risk behaviors to alternate deferral options, such as the use of individual risk assessments; and

WHEREAS, A 12-month deferral policy for gay and bisexual men to donate blood is overly stringent given the scientific evidence, advanced testing methods, and the safety and quality control measures in place within the different FDA-qualified blood donating centers; and

WHEREAS, The American Public Health Association has stated that no specific scientific rationale is provided to justify the 12-month deferral policy. The technology can identify within 7 to 10 days with 99.9 percent accuracy whether or not a blood sample is HIV-positive, and the chance of the blood test being inaccurate within the 10-day window is about 1 in 2,000,000; and

WHEREAS, The General Social Survey conducted by NORC at the University of Chicago estimates that 8.5 percent of men in the United States have had at least one male sex partner since 18 years of age, 4.1 percent of men report at least one male sex partner in the last 5 years, and 3.8 percent report a male sex partner in the last 12 months; and

WHEREAS, An estimated 45.4 percent of men (54 million) in the United States are eligible to donate blood, but only 8.7 percent of eligible men actually do. There are 15.7 million donations of blood per year made by 9.2 million donors, yielding approximately 1.7 donations per donor; and

WHEREAS, The Williams Institute of the University of California at Los Angeles School of Law estimates that, based on the population of eligible and likely donors among the MSM community, lifting the federal lifetime deferral policy on blood donation by an MSM would result in 4.2 million newly eligible male donors, of which 360,600 would likely donate, generating 615,300 additional pints of blood. Applying national estimates to the California population, the Institute further estimates that lifting the ban on MSM blood donations would add an additional 510,000 eligible men to the current blood donor pool, of which 43,917 would likely donate, resulting in an additional 74,945 donated pints in California; and

WHEREAS, One hundred fifteen members of the Congress of the United States sent a letter to the FDA Commissioner, Dr. Robert M. Califf, M.D., urging him to finally put an end to this outdated blood donation policy and update it to reflect science, not fear; now, therefore, be it

Resolved by the Senate and the Assembly of the State of California, jointly, That the California State Legislature calls upon the President of the United States to encourage the Secretary of the United States Department of Health and Human Services to adopt policies to repeal the current discriminatory donor suitability policies of the United States Food and Drug Administration (FDA) regarding blood donations by men who have had sex with another man and, instead, direct the FDA to develop science-based policies such as criteria based on risky behavior in lieu of sexual orientation; and be it further

Resolved, That the Secretary of the Senate transmit copies of this resolution to the President and Vice President of the United States, to the Secretary of the United States Department of Health and Human Services, to the Speaker of the House of Representatives, to the Majority Leader of the Senate, and to each Senator and Representative from California in the Congress of the United States.

WHEREAS, Since 1983, the United States Food and Drug Administration (FDA), an agency under the United States Department of Health and Human Services (HHS), had prohibited the donation of blood by any man who has had sex with another man (MSM) at any time since 1977; and

WHEREAS, In December 2015, based on recommendations from the HHS Advisory Committee on Blood and Tissue Safety and Availability, the FDA promulgated revised regulations to allow an MSM to donate blood only if he has not been sexually active for the past 12 months. Despite these recent steps toward a policy change, a double standard would still exist under the policy as it is proposed to be revised because it would still treat gay and bisexual men differently from heterosexual men; and

WHEREAS, California law prohibits discrimination against individuals on the basis of actual or perceived sex, sexual orientation, gender identity, and gender-related appearance and behavior; and

WHEREAS, Argentina, Italy, Mexico, Poland, Portugal, Russia, South Africa, South Korea, and Spain have adopted blood donor policies that measure risk against a set of behaviors, sexual and otherwise, rather than the sex of a persons sexual partner or partners; and

WHEREAS, The FDA currently does not allow gay and bisexual men in committed relationships to donate blood because, while one partner may be monogamous, that individual cannot guarantee that the other partner is monogamous. The FDA does not apply this same logic to heterosexual relationships, which in effect discriminates against gay and bisexual men; and

WHEREAS, The FDA is in the process of again reevaluating and considering updating its blood donor deferral policies as new scientific information becomes available, including the feasibility of moving from the existing time-based deferrals related to risk behaviors to alternate deferral options, such as the use of individual risk assessments; and

WHEREAS, A 12-month deferral policy for gay and bisexual men to donate blood is overly stringent given the scientific evidence, advanced testing methods, and the safety and quality control measures in place within the different FDA-qualified blood donating centers; and

WHEREAS, The American Public Health Association has stated that no specific scientific rationale is provided to justify the 12-month deferral policy. The technology can identify within 7 to 10 days with 99.9 percent accuracy whether or not a blood sample is HIV-positive, and the chance of the blood test being inaccurate within the 10-day window is about 1 in 2,000,000; and

WHEREAS, The General Social Survey conducted by NORC at the University of Chicago estimates that 8.5 percent of men in the United States have had at least one male sex partner since 18 years of age, 4.1 percent of men report at least one male sex partner in the last 5 years, and 3.8 percent report a male sex partner in the last 12 months; and

WHEREAS, An estimated 45.4 percent of men (54 million) in the United States are eligible to donate blood, but only 8.7 percent of eligible men actually do. There are 15.7 million donations of blood per year made by 9.2 million donors, yielding approximately 1.7 donations per donor; and

WHEREAS, The Williams Institute of the University of California at Los Angeles School of Law estimates that, based on the population of eligible and likely donors among the MSM community, lifting the federal lifetime deferral policy on blood donation by an MSM would result in 4.2 million newly eligible male donors, of which 360,600 would likely donate, generating 615,300 additional pints of blood. Applying national estimates to the California population, the Institute further estimates that lifting the ban on MSM blood donations would add an additional 510,000 eligible men to the current blood donor pool, of which 43,917 would likely donate, resulting in an additional 74,945 donated pints in California; and

WHEREAS, One hundred fifteen members of the Congress of the United States sent a letter to the FDA Commissioner, Dr. Robert M. Califf, MD, urging him to finally put an end to this outdated blood donation policy and update it to reflect science, not fear; now, therefore, be it

Resolved by the Senate and the Assembly of the State of California, jointly, That the California State Legislature calls upon the President of the United States to encourage the Secretary of the United States Department of Health and Human Services to adopt policies to repeal the current discriminatory donor suitability policies of the United States Food and Drug Administration (FDA) regarding blood donations by men who have had sex with another man and, instead, direct the FDA to develop science-based policies such as criteria based on risky behavior in lieu of sexual orientation; and be it further

Resolved, That the Secretary of the Senate transmit copies of this resolution to the President and Vice President of the United States, to the Secretary of the United States Department of Health and Human Services, to the Speaker of the House of Representatives, to the Majority Leader of the Senate, and to each Senator and Representative from California in the Congress of the United States.

WHEREAS, Since 1983, the United States Food and Drug Administration (FDA), an agency under the United States Department of Health and Human Services (HHS), had prohibited the donation of blood by any man who has had sex with another man (MSM) at any time since 1977; and

WHEREAS, In December 2015, based on recommendations from the HHS Advisory Committee on Blood and Tissue Safety and Availability, the FDA promulgated revised regulations to allow an MSM to donate blood only if he has not been sexually active for the past 12 months. Despite these recent steps toward a policy change, a double standard would still exist under the policy as it is proposed to be revised because it would still treat gay and bisexual men differently from heterosexual men; and

WHEREAS, California law prohibits discrimination against individuals on the basis of actual or perceived sex, sexual orientation, gender identity, and gender-related appearance and behavior; and

WHEREAS, Argentina, Italy, Mexico, Poland, Portugal, Russia, South Africa, South Korea, and Spain have adopted blood donor policies that measure risk against a set of behaviors, sexual and otherwise, rather than the sex of a persons sexual partner or partners; and

WHEREAS, The FDA does not allow gay and bisexual men in committed relationships to donate blood because, while one partner may be monogamous, that individual cannot guarantee that the other partner is monogamous. The FDA does not apply this same logic to heterosexual relationships, which in effect discriminates against gay and bisexual men; and

WHEREAS, A 12-month deferral policy for gay and bisexual men to donate blood is overly stringent given the scientific evidence, advanced testing methods, and the safety and quality control measures in place within the different FDA-qualified blood donating centers; and

WHEREAS, The American Public Health Association has stated that no specific scientific rationale is provided to justify the 12-month deferral policy. The technology can identify within 7 to 10 days with 99.9 percent accuracy whether or not a blood sample is HIV-positive, and the chance of the blood test being inaccurate within the 10-day window is about 1 in 2,000,000; and

WHEREAS, The General Social Survey conducted by NORC at the University of Chicago estimates that 8.5 percent of men in the United States have had at least one male sex partner since 18 years of age, 4.1 percent of men report at least one male sex partner in the last 5 years, and 3.8 percent report a male sex partner in the last 12 months; and

WHEREAS, An estimated 45.4 percent of men (54 million) in the United States are eligible to donate blood, but only 8.7 percent of eligible men actually do. There are 15.7 million donations of blood per year made by 9.2 million donors, yielding approximately 1.7 donations per donor; and

WHEREAS, The Williams Institute of the University of California at Los Angeles School of Law estimates that, based on the population of eligible and likely donors among the MSM community, lifting the federal lifetime deferral policy on blood donation by an MSM would result in 4.2 million newly eligible male donors, of which 360,600 would likely donate, generating 615,300 additional pints of blood. Applying national estimates to the California population, the Institute further estimates that lifting the ban on MSM blood donations would add an additional 510,000 eligible men to the current blood donor pool, of which 43,917 would likely donate, resulting in an additional 74,945 donated pints in California; and

WHEREAS, One hundred fifteen members of the Congress of the United States sent a letter to the FDA Commissioner, Dr. Robert M. Califf, MD, urging him to finally put an end to this outdated blood donation policy and update it to reflect science, not fear; now, therefore, be it

Resolved by the Senate and the Assembly of the State of California, jointly, That the California State Legislature calls upon the President of the United States to encourage the Secretary of the United States Department of Health and Human Services to adopt policies to repeal the current discriminatory donor suitability policies of the United States Food and Drug Administration (FDA) regarding blood donations by men who have had sex with another man and, instead, direct the FDA to develop science-based policies such as criteria based on risky behavior in lieu of sexual orientation; and be it further

Resolved, That the Secretary of the Senate transmit copies of this resolution to the President and Vice President of the United States, to the Secretary of the United States Department of Health and Human Services, to the Speaker of the House of Representatives, to the Majority Leader of the Senate, and to each Senator and Representative from California in the Congress of the United States.

 UNFINISHED BUSINESS 

Bill No: SJR 26

Author: De León (D), et al.

Amended: 8/17/16

Vote: 21

SENATE FLOOR: 34-0, 8/11/16

AYES: Allen, Anderson, Bates, Beall, Berryhill, Block, Cannella, De León, Fuller, Gaines, Galgiani, Glazer, Hernandez, Hertzberg, Hill, Hueso, Huff, Jackson, Lara, Leno, Leyva, Liu, McGuire, Mitchell, Monning, Nguyen, Nielsen, Pan, Pavley, Roth, Stone, Vidak, Wieckowski, Wolk

NO VOTE RECORDED: Hall, Hancock, Mendoza, Moorlach, Morrell

ASSEMBLY FLOOR: Read and adopted, 8/30/16

SUBJECT: Blood donations

SOURCE: Author

DIGEST:

This resolution calls upon the President of the United States to encourage the Secretary of the United States Department of Health and Human Services (HHS) to adopt policies to repeal the current discriminatory donor suitability policies of the United States Food and Drug Administration (FDA) regarding blood donations by men who have had sex with another man and, instead, direct the FDA to develop science-based policies such as criteria based on risky behavior in lieu of sexual orientation.

Assembly Amendments

make technical changes and add coauthor.

ANALYSIS: This resolution makes the following legislative findings:

1. Since 1983, the FDA, an agency under the HHS, had prohibited the donation of blood by any man who has had sex with another man (MSM) at any time since 1977.
2. In December 2015, based on recommendations from the HHS Advisory Committee on Blood and Tissue Safety and Availability, the FDA promulgated revised regulations to allow an MSM to donate blood only if he has not been sexually active for the past 12 months. Despite these recent steps toward a policy change, a double standard would still exist under the policy as it is proposed to be revised because it would still treat gay and bisexual men differently from heterosexual men.
3. The FDA currently does not allow gay and bisexual men in committed relationships to donate blood because, while one partner may be monogamous, that individual cannot guarantee that the other partner is monogamous. The FDA does not apply this same logic to heterosexual relationships, which in effect discriminates against gay and bisexual men.
4. The FDA is in the process of again reevaluating and considering updating its blood donor deferral policies as new scientific information becomes available, including the feasibility of moving from the existing time-based deferrals related to risk behaviors to alternate deferral options, such as the use of individual risk assessments.
5. The American Public Health Association has stated that no specific scientific rationale is provided to justify the 12-month deferral policy. The technology can identify within 7 to 10 days with 99.9 percent accuracy whether or not a blood sample is HIV-positive, and the chance of the blood test being inaccurate within the 10-day window is about 1 in 2,000,000.
6. The Williams Institute of the University of California at Los Angeles School of Law estimates that, based on the population of eligible and likely donors among the MSM community, lifting the federal lifetime deferral policy on blood donation by an MSM would result in 4.2 million newly eligible male donors, of which 360,600 would likely donate, generating 615,300 additional pints of blood. Applying national estimates to the California population, the Institute further estimates that lifting the ban on MSM blood donations would add an additional 510,000 eligible men to the current blood donor pool, of which 43,917 would likely donate, resulting in an additional 74,945 donated pints in California.

This resolution calls upon the President of the United States to encourage the Secretary of the United States Department of Health and Human Services to adopt policies to repeal the current discriminatory donor suitability policies of the FDA regarding blood donations by men who have had sex with another man and, instead, direct the FDA to develop science-based policies such as criteria based on risky behavior in lieu of sexual orientation.

Background

Technological Advances in Blood Testing. One important factor in developing blood donation deferral policies is the length of the window period. The window period is the time span between when a person contracts HIV and when an HIV test can detect the virus within the person’s body.

There are two main types of tests which can be used to test blood for HIV: the antibody test and the nucleic acid test (NAT). The antibody test assesses whether any HIV-targeted antibodies are in a person’s body. The NAT test looks for HIV in the blood. The NAT test is what is generally used to test donated blood because it has a shorter window period than the antibody test does. For most people, the window period for the antibody test is between two to eight weeks with an average of twenty-five days. Meanwhile, the window period for the NAT test is only nine to 11 days long.

In part because of recent advances in testing technology, the risk of transmitting HIV through blood donation has decreased to 1 in 1.47 million. Since the NAT test can detect HIV in blood samples within such a short span of time, this diminishes the need for a yearlong ban on MSM. Instead, the deferral period for individuals who have been deemed high-risk through a risk-assessment test can be reduced to a shorter timespan. Only those who have participated in high-risk activity would be deferred, and the time for which they would be deferred would be based on advancements in the technology used to test donated blood.

Comments

Why support a risk-assessment approach? According to the author:

An individual risk-assessment approach would evaluate the risk-level of behaviors of potential donors instead of banning entire “at-risk” groups from donating, such as MSM. Some higher risk activities which could be screened for using this model are whether or not a potential donor has engaged in unprotected anal sex, had sex with a person of an unknown HIV status in the past three months, or has had unprotected sex with multiple partners in the past three months, amongst other potentially risky behaviors.

While this list of risky sexual acts can apply to the MSM community, it also demonstrates that heterosexual donors could be engaging in high-risk sexual or recreational activity which puts them at a greater risk of contracting HIV. Having blanket deferral policies not only spreads a false misconception that heterosexual sex is safe from HIV exposure, but it also does not educate donors about what behaviors put one at a greater risk. Adding these risk assessment questions further protects the blood supply because it bans high-risk activities that any donor, no matter their race, sexual orientation, or gender, could partake in.

Prior Legislation

AJR 16 (Eduardo Garcia, Resolution Chapter 194, Statutes of 2015) called upon the President of the United States to encourage the Secretary of the HHS to adopt policies to repeal the current and upcoming discriminatory donor suitability policies of the FDA regarding blood donations by men who have had sex with another man and, instead, direct the FDA to develop science-based policies such as criteria based on risky behavior in lieu of sexual orientation.

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

SUPPORT: (Verified 8/31/16)

APLA Health

Access Support Network of San Luis Obispo and Monterey Counties

Equality California

Project Inform

OPPOSITION: (Verified 8/31/16)

None received

Prepared by: Karen Chow / SFA / (916) 651-1520

8/31/16 18:45:07

**** END ****

 UNFINISHED BUSINESS 

Bill No: SJR 26

Author: De León (D), et al.

Amended: 8/17/16

Vote: 21

SENATE FLOOR: 34-0, 8/11/16

AYES: Allen, Anderson, Bates, Beall, Berryhill, Block, Cannella, De León, Fuller, Gaines, Galgiani, Glazer, Hernandez, Hertzberg, Hill, Hueso, Huff, Jackson, Lara, Leno, Leyva, Liu, McGuire, Mitchell, Monning, Nguyen, Nielsen, Pan, Pavley, Roth, Stone, Vidak, Wieckowski, Wolk

NO VOTE RECORDED: Hall, Hancock, Mendoza, Moorlach, Morrell

ASSEMBLY FLOOR: Read and adopted, 8/30/16

SUBJECT: Blood donations

SOURCE: Author

DIGEST:

This resolution calls upon the President of the United States to encourage the Secretary of the United States Department of Health and Human Services (HHS) to adopt policies to repeal the current discriminatory donor suitability policies of the United States Food and Drug Administration (FDA) regarding blood donations by men who have had sex with another man and, instead, direct the FDA to develop science-based policies such as criteria based on risky behavior in lieu of sexual orientation.

Assembly Amendments

make technical changes and add coauthor.

ANALYSIS: This resolution makes the following legislative findings:

1. Since 1983, the FDA, an agency under the HHS, had prohibited the donation of blood by any man who has had sex with another man (MSM) at any time since 1977.
2. In December 2015, based on recommendations from the HHS Advisory Committee on Blood and Tissue Safety and Availability, the FDA promulgated revised regulations to allow an MSM to donate blood only if he has not been sexually active for the past 12 months. Despite these recent steps toward a policy change, a double standard would still exist under the policy as it is proposed to be revised because it would still treat gay and bisexual men differently from heterosexual men.
3. The FDA currently does not allow gay and bisexual men in committed relationships to donate blood because, while one partner may be monogamous, that individual cannot guarantee that the other partner is monogamous. The FDA does not apply this same logic to heterosexual relationships, which in effect discriminates against gay and bisexual men.
4. The FDA is in the process of again reevaluating and considering updating its blood donor deferral policies as new scientific information becomes available, including the feasibility of moving from the existing time-based deferrals related to risk behaviors to alternate deferral options, such as the use of individual risk assessments.
5. The American Public Health Association has stated that no specific scientific rationale is provided to justify the 12-month deferral policy. The technology can identify within 7 to 10 days with 99.9 percent accuracy whether or not a blood sample is HIV-positive, and the chance of the blood test being inaccurate within the 10-day window is about 1 in 2,000,000.
6. The Williams Institute of the University of California at Los Angeles School of Law estimates that, based on the population of eligible and likely donors among the MSM community, lifting the federal lifetime deferral policy on blood donation by an MSM would result in 4.2 million newly eligible male donors, of which 360,600 would likely donate, generating 615,300 additional pints of blood. Applying national estimates to the California population, the Institute further estimates that lifting the ban on MSM blood donations would add an additional 510,000 eligible men to the current blood donor pool, of which 43,917 would likely donate, resulting in an additional 74,945 donated pints in California.

This resolution calls upon the President of the United States to encourage the Secretary of the United States Department of Health and Human Services to adopt policies to repeal the current discriminatory donor suitability policies of the FDA regarding blood donations by men who have had sex with another man and, instead, direct the FDA to develop science-based policies such as criteria based on risky behavior in lieu of sexual orientation.

Background

Technological Advances in Blood Testing. One important factor in developing blood donation deferral policies is the length of the window period. The window period is the time span between when a person contracts HIV and when an HIV test can detect the virus within the person’s body.

There are two main types of tests which can be used to test blood for HIV: the antibody test and the nucleic acid test (NAT). The antibody test assesses whether any HIV-targeted antibodies are in a person’s body. The NAT test looks for HIV in the blood. The NAT test is what is generally used to test donated blood because it has a shorter window period than the antibody test does. For most people, the window period for the antibody test is between two to eight weeks with an average of twenty-five days. Meanwhile, the window period for the NAT test is only nine to 11 days long.

In part because of recent advances in testing technology, the risk of transmitting HIV through blood donation has decreased to 1 in 1.47 million. Since the NAT test can detect HIV in blood samples within such a short span of time, this diminishes the need for a yearlong ban on MSM. Instead, the deferral period for individuals who have been deemed high-risk through a risk-assessment test can be reduced to a shorter timespan. Only those who have participated in high-risk activity would be deferred, and the time for which they would be deferred would be based on advancements in the technology used to test donated blood.

Comments

Why support a risk-assessment approach? According to the author:

An individual risk-assessment approach would evaluate the risk-level of behaviors of potential donors instead of banning entire “at-risk” groups from donating, such as MSM. Some higher risk activities which could be screened for using this model are whether or not a potential donor has engaged in unprotected anal sex, had sex with a person of an unknown HIV status in the past three months, or has had unprotected sex with multiple partners in the past three months, amongst other potentially risky behaviors.

While this list of risky sexual acts can apply to the MSM community, it also demonstrates that heterosexual donors could be engaging in high-risk sexual or recreational activity which puts them at a greater risk of contracting HIV. Having blanket deferral policies not only spreads a false misconception that heterosexual sex is safe from HIV exposure, but it also does not educate donors about what behaviors put one at a greater risk. Adding these risk assessment questions further protects the blood supply because it bans high-risk activities that any donor, no matter their race, sexual orientation, or gender, could partake in.

Prior Legislation

AJR 16 (Eduardo Garcia, Resolution Chapter 194, Statutes of 2015) called upon the President of the United States to encourage the Secretary of the HHS to adopt policies to repeal the current and upcoming discriminatory donor suitability policies of the FDA regarding blood donations by men who have had sex with another man and, instead, direct the FDA to develop science-based policies such as criteria based on risky behavior in lieu of sexual orientation.

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

SUPPORT: (Verified 8/31/16)

APLA Health

Access Support Network of San Luis Obispo and Monterey Counties

Equality California

Project Inform

OPPOSITION: (Verified 8/31/16)

None received

Prepared by: Karen Chow / SFA / (916) 651-1520

8/31/16 20:34:55

**** END ****

 UNFINISHED BUSINESS 

Bill No: SJR 26

Author: De León (D), et al.

Amended: 8/17/16

Vote: 21

SENATE FLOOR: 34-0, 8/11/16

AYES: Allen, Anderson, Bates, Beall, Berryhill, Block, Cannella, De León, Fuller, Gaines, Galgiani, Glazer, Hernandez, Hertzberg, Hill, Hueso, Huff, Jackson, Lara, Leno, Leyva, Liu, McGuire, Mitchell, Monning, Nguyen, Nielsen, Pan, Pavley, Roth, Stone, Vidak, Wieckowski, Wolk

NO VOTE RECORDED: Hall, Hancock, Mendoza, Moorlach, Morrell

ASSEMBLY FLOOR: Read and adopted, 8/30/16

SUBJECT: Blood donations

SOURCE: Author

DIGEST:

This resolution calls upon the President of the United States to encourage the Secretary of the United States Department of Health and Human Services (HHS) to adopt policies to repeal the current discriminatory donor suitability policies of the United States Food and Drug Administration (FDA) regarding blood donations by men who have had sex with another man and, instead, direct the FDA to develop science-based policies such as criteria based on risky behavior in lieu of sexual orientation.

Assembly Amendments

make technical changes and add coauthor.

ANALYSIS: This resolution makes the following legislative findings:

1. Since 1983, the FDA, an agency under the HHS, had prohibited the donation of blood by any man who has had sex with another man (MSM) at any time since 1977.
2. In December 2015, based on recommendations from the HHS Advisory Committee on Blood and Tissue Safety and Availability, the FDA promulgated revised regulations to allow an MSM to donate blood only if he has not been sexually active for the past 12 months. Despite these recent steps toward a policy change, a double standard would still exist under the policy as it is proposed to be revised because it would still treat gay and bisexual men differently from heterosexual men.
3. The FDA currently does not allow gay and bisexual men in committed relationships to donate blood because, while one partner may be monogamous, that individual cannot guarantee that the other partner is monogamous. The FDA does not apply this same logic to heterosexual relationships, which in effect discriminates against gay and bisexual men.
4. The FDA is in the process of again reevaluating and considering updating its blood donor deferral policies as new scientific information becomes available, including the feasibility of moving from the existing time-based deferrals related to risk behaviors to alternate deferral options, such as the use of individual risk assessments.
5. The American Public Health Association has stated that no specific scientific rationale is provided to justify the 12-month deferral policy. The technology can identify within 7 to 10 days with 99.9 percent accuracy whether or not a blood sample is HIV-positive, and the chance of the blood test being inaccurate within the 10-day window is about 1 in 2,000,000.
6. The Williams Institute of the University of California at Los Angeles School of Law estimates that, based on the population of eligible and likely donors among the MSM community, lifting the federal lifetime deferral policy on blood donation by an MSM would result in 4.2 million newly eligible male donors, of which 360,600 would likely donate, generating 615,300 additional pints of blood. Applying national estimates to the California population, the Institute further estimates that lifting the ban on MSM blood donations would add an additional 510,000 eligible men to the current blood donor pool, of which 43,917 would likely donate, resulting in an additional 74,945 donated pints in California.

This resolution calls upon the President of the United States to encourage the Secretary of the United States Department of Health and Human Services to adopt policies to repeal the current discriminatory donor suitability policies of the FDA regarding blood donations by men who have had sex with another man and, instead, direct the FDA to develop science-based policies such as criteria based on risky behavior in lieu of sexual orientation.

Background

Technological Advances in Blood Testing. One important factor in developing blood donation deferral policies is the length of the window period. The window period is the time span between when a person contracts HIV and when an HIV test can detect the virus within the person’s body.

There are two main types of tests which can be used to test blood for HIV: the antibody test and the nucleic acid test (NAT). The antibody test assesses whether any HIV-targeted antibodies are in a person’s body. The NAT test looks for HIV in the blood. The NAT test is what is generally used to test donated blood because it has a shorter window period than the antibody test does. For most people, the window period for the antibody test is between two to eight weeks with an average of twenty-five days. Meanwhile, the window period for the NAT test is only nine to 11 days long.

In part because of recent advances in testing technology, the risk of transmitting HIV through blood donation has decreased to 1 in 1.47 million. Since the NAT test can detect HIV in blood samples within such a short span of time, this diminishes the need for a yearlong ban on MSM. Instead, the deferral period for individuals who have been deemed high-risk through a risk-assessment test can be reduced to a shorter timespan. Only those who have participated in high-risk activity would be deferred, and the time for which they would be deferred would be based on advancements in the technology used to test donated blood.

Comments

Why support a risk-assessment approach? According to the author:

An individual risk-assessment approach would evaluate the risk-level of behaviors of potential donors instead of banning entire “at-risk” groups from donating, such as MSM. Some higher risk activities which could be screened for using this model are whether or not a potential donor has engaged in unprotected anal sex, had sex with a person of an unknown HIV status in the past three months, or has had unprotected sex with multiple partners in the past three months, amongst other potentially risky behaviors.

While this list of risky sexual acts can apply to the MSM community, it also demonstrates that heterosexual donors could be engaging in high-risk sexual or recreational activity which puts them at a greater risk of contracting HIV. Having blanket deferral policies not only spreads a false misconception that heterosexual sex is safe from HIV exposure, but it also does not educate donors about what behaviors put one at a greater risk. Adding these risk assessment questions further protects the blood supply because it bans high-risk activities that any donor, no matter their race, sexual orientation, or gender, could partake in.

Prior Legislation

AJR 16 (Eduardo Garcia, Resolution Chapter 194, Statutes of 2015) called upon the President of the United States to encourage the Secretary of the HHS to adopt policies to repeal the current and upcoming discriminatory donor suitability policies of the FDA regarding blood donations by men who have had sex with another man and, instead, direct the FDA to develop science-based policies such as criteria based on risky behavior in lieu of sexual orientation.

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

SUPPORT: (Verified 8/31/16)

APLA Health

Access Support Network of San Luis Obispo and Monterey Counties

Equality California

Project Inform

OPPOSITION: (Verified 8/31/16)

None received

Prepared by: Karen Chow / SFA / (916) 651-1520

8/31/16 21:04:34

**** END ****

SENATE THIRD READING

STR Bill Id:SJR 26

Author:(De León)

As Amended Ver:August 17, 2016

Majority vote

SENATE VOTE: 34-0

SUMMARY: Calls upon the President of the United States to encourage the Secretary of the United States Department of Health and Human Services (HHS) to adopt policies to repeal the current discriminatory donor suitability policies of the United States Food and Drug Administration (FDA) regarding blood donations by men who have had sex with another man (MSM) and, instead, direct the FDA to develop science-based policies such as criteria based on risky behavior in lieu of sexual orientation. Specifically, this resolution:

1. Finds that since 1983 the FDA had prohibited the donation of blood by any MSM at any time since 1977.
2. Finds that in December 2015, based on recommendations from the HHS Advisory Committee on Blood and Tissue Safety and Availability, the FDA promulgated revised regulations to allow an MSM to donate blood only if he has not been sexually active for the past 12 months, and that despite these recent steps toward a policy change, a double standard exists under the policy as revised because it still treats gay and bisexual men differently from heterosexual men.
3. Finds that California law prohibits discrimination against individuals on the basis of actual or perceived sex, sexual orientation, gender identity, and gender-related appearance and behavior. Finds that Argentina, Italy, Mexico, Poland, Portugal, Russia, South Africa, South Korea, and Spain have adopted blood donor policies that measure risk against a set of behaviors, sexual and otherwise, rather than the sex of a person's sexual partner or partners.
4. Finds that the FDA does not currently allow gay and bisexual men in committed relationships to donate blood because, while one partner may be monogamous, that individual cannot guarantee that the other partner is monogamous and that the FDA does not apply this same logic to heterosexual relationships, which in effect discriminates against gay and bisexual men.
5. Finds that the FDA is in the process of again reevaluating and considering updating its blood donor deferral policies as new scientific information becomes available, including the feasibility of moving from the existing time-based deferrals related to risk behaviors to alternate deferral options, such as the use of individual risk assessments.
6. Finds that the American Public Health Association has stated that no specific scientific rationale is provided to justify the 12-month blood donation deferral policy for gay and bisexual men.
7. Finds that the Williams Institute of the University of California at Los Angeles School of Law (Institute) estimates that, based on the population of eligible and likely donors among the MSM community, lifting the federal lifetime deferral policy on blood donation by an MSM would result in 4.2 million newly eligible male donors, of which 360,600 would likely donate, generating 615,300 pints of blood and applying national estimates to the California population the Institute estimates lifting the ban would add an additional 510,000 eligible men to the blood donor pool, resulting in an additional 74,945 pints of blood in California.

EXISTING LAW: Provides that all persons within the jurisdiction of this state are free and equal. Prohibits discrimination based on sex, race, color, religion, ancestry, national origin, disability, medical condition, marital status, or sexual orientation with respect to accommodations, advantages, facilities, privileges, or services in all business establishments of every kind.

FISCAL EFFECT: None.

COMMENTS: According to the author last year, both houses passed a similar measure, AJR 16 (Eduardo Garcia), Resolution Chapter 194, Statutes of 2015, on a bipartisan vote, however, recent events and a new FDA guideline make it important for the Legislature to go on record again on this issue. The author states that since 1983 the FDA policy, adopted when the scientific and medical community knew very little about human immunodeficiency virus (HIV) transmission, was a lifetime ban on blood donation for any men who had sex with men, however, last year, the FDA finally reconsidered, acknowledging that the policy was not in line with current scientific understanding and was unnecessarily discriminatory. The author notes in spite of overwhelming scientific evidence to the contrary, instead of an individual "risk-assessment" approach, the FDA adopted an arbitrary one year ban. In late July, the FDA announced that it is officially reconsidering the blood donations policy and has put out a formal request for public comment. The request specifically states that the FDA wants to ensure that the policy reflects the most up-to-date scientific knowledge. The author concludes that the purpose of this resolution is to put the California Legislature on record with the FDA urging a scientific-based, individual risk assessment policy.

1. Revised Recommendations for Reducing the Risk of HIV Transmission by Blood and Blood Products. The FDA recommends that blood establishments defer potential donors as follows:
   1. Defer indefinitely an individual who has ever had a positive test for HIV;
   2. Defer indefinitely an individual who has ever exchanged sex for money or drugs;
   3. Defer for 12 months from the most recent contact any individual who has a history of sex with a person who: has ever had a positive test for HIV; ever exchanged sex for money or drugs; or, ever engaged in non-prescription injection drug use;
   4. Defer for 12 months from the most recent transfusion any individual who has a history of receiving a transfusion of Whole Blood or blood components donated by another person;
   5. Defer for 12 months the most recent exposure any individual who has a history of through-the-skin contact with the blood of another individual, such as a needle stick or blood contact with an open wound or mucous membrane;
   6. Defer for 12 months from the most recent tattoo, ear or body piercing;
   7. Defer for 12 months after completion of treatment of any individual with a history of syphilis or gonorrhea or with a history of diagnosis or treatment for syphilis or gonorrhea in the past 12 months;
   8. Defer for 12 months from the most recent contact a man who has had sex with another man during the past 12 months; and,
   9. Defer for 12 months from the most recent contact a female who has had sex during the past 12 months with a man who has had sex with another man in the past 12 months.
2. Technological Advances in Blood Testing. One important factor in developing blood donation deferral policies is the length of what is called the window period. The window period is the time span between when a person contracts HIV and when an HIV test can detect the virus within the person's body.

There are two main types of tests which can be used to test blood for HIV: the antibody test and the nucleic acid test (NAT). The antibody test assesses whether any HIV-targeted antibodies are in a person's body. The NAT test looks for HIV in the blood. The NAT test is what is generally used to test donated blood because it has a shorter window period than the antibody test does. For most people, the window period for the antibody test is between two to eight weeks with an average of 25 days. Meanwhile, the window period for the NAT test is only nine to 11 days long.

In part because of recent advances in testing technology, the risk of transmitting HIV through blood donation has decreased to one in 1.47 million. Since the NAT test can detect HIV in blood samples within such a short span of time, this diminishes the need for a yearlong ban on MSM. Instead, the deferral period for individuals who have been deemed high-risk through a risk-assessment test can be reduced to a shorter time span. Only those who have participated in high-risk activity would be deferred, and the time for which they would be deferred would be based on advancements in the technology used to test donated blood.

1. Individual risk-assessment. The individual risk-assessment approach would evaluate the risk-level of behaviors of potential donors instead of banning entire "at-risk" groups from donating, such as MSM. Some higher risk activities which could be screened for using this model are whether or not a potential donor has engaged in unprotected anal sex, had sex with a person of an unknown HIV status in the past three months, or has had unprotected sex with multiple partners in the past three months, amongst other potentially risky behaviors. While this list of risky sexual acts can apply to the MSM community, it also demonstrates that heterosexual donors could be engaging in high-risk sexual or recreational activity which puts them at a greater risk of contracting HIV. Having blanket deferral policies not only spreads a false misconception that heterosexual sex is safe from HIV exposure, but it also does not educate donors about what behaviors put one at a greater risk. Adding these risk assessment questions further protects the blood supply because it bans high-risk activities that any donor, no matter their race, sexual orientation, or gender, could partake in.
2. Current FDA process for reevaluating blood donor deferral policies. On July 26, 2016, the FDA issued a notice in the Federal Register titled "Blood Donor Deferral Policy for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products." FDA issued a Final Guidance in December 2015 that changed the decades-old indefinite blood donor deferral policy regarding MSM to a one-year deferral since the last sexual contact with another man.

This change better aligns the deferral period with that of other men and women engaging in behaviors that place them at increased risk for HIV infection (e.g., those who had a recent blood transfusion or accidental exposure to the blood of another individual, or had other potential exposure to a potentially blood borne disease). When this policy was updated in 2015, the FDA promised to continue to reconsider the donor deferral policies as new data become available. The FDA is seeking science-based comments to the newly opened docket on:

• • 1. The feasibility of moving from the existing time-based deferrals related to risk behaviors to alternate deferral options, such as the use of individual risk assessment;
    2. The design of potential studies to evaluate the feasibility or effectiveness of such alternative deferral policy options; and,
    3. Other science-based comments that will help shape future decisions.

The public docket will be open for comments until November 25, 2016.

Analysis Prepared by: Lara Flynn / HEALTH / (916) 319-2097 FN: 0005005

Date of Hearing: August 30, 2016

ASSEMBLY COMMITTEE ON HEALTH

Jim Wood, Chair

SBPCA Bill Id:SJR 26

Author:(De León) – As Amended Ver:August 17, 2016

SENATE VOTE: 34-0

SUBJECT: Blood donations

SUMMARY: Calls upon the President of the United States to encourage the Secretary of the United States Department of Health and Human Services (HHS) to adopt policies to repeal the current discriminatory donor suitability policies of the United States Food and Drug Administration (FDA) regarding blood donations by men who have had sex with another man (MSM) and, instead, direct the FDA to develop science-based policies such as criteria based on risky behavior in lieu of sexual orientation. Specifically, this resolution:

1. Finds that since 1983 the FDA had prohibited the donation of blood by any MSM at any time since 1977.
2. Finds that in December 2015, based on recommendations from the HHS Advisory Committee on Blood and Tissue Safety and Availability, the FDA promulgated revised regulations to allow an MSM to donate blood only if he has not been sexually active for the past 12 months, and that despite these recent steps toward a policy change, a double standard exists under the policy as revised because it still treats gay and bisexual men differently from heterosexual men.
3. Finds that California law prohibits discrimination against individuals on the basis of actual or perceived sex, sexual orientation, gender identity, and gender-related appearance and behavior. Finds that Argentina, Italy, Mexico, Poland, Portugal, Russia, South Africa, South Korea, and Spain have adopted blood donor policies that measure risk against a set of behaviors, sexual and otherwise, rather than the sex of a person's sexual partner or partners.
4. Finds that the FDA does not currently allow gay and bisexual men in committed relationships to donate blood because, while one partner may be monogamous, that individual cannot guarantee that the other partner is monogamous and that the FDA does not apply this same logic to heterosexual relationships, which in effect discriminates against gay and bisexual men.
5. Finds that the FDA is in the process of again reevaluating and considering updating its blood donor deferral policies as new scientific information becomes available, including the feasibility of moving from the existing time-based deferrals related to risk behaviors to alternate deferral options, such as the use of individual risk assessments.
6. Finds that the American Public Health Association has stated that no specific scientific rationale is provided to justify the 12-month blood donation deferral policy for gay and bisexual men.
7. Finds that the Williams Institute of the University of California at Los Angeles School of Law (Institute) estimates that, based on the population of eligible and likely donors among the MSM community, lifting the federal lifetime deferral policy on blood donation by an MSM would result in 4.2 million newly eligible male donors, of which 360,600 would likely donate, generating 615,300 pints of blood and applying national estimates to the California population the Institute estimates lifting the ban would add an additional 510,000 eligible men to the blood donor pool, resulting in an additional 74,945 pints of blood in California.

EXISTING LAW: Provides that all persons within the jurisdiction of this state are free and equal. Prohibits discrimination based on sex, race, color, religion, ancestry, national origin, disability, medical condition, marital status, or sexual orientation with respect to accommodations, advantages, facilities, privileges, or services in all business establishments of every kind.

FISCAL EFFECT: None.

COMMENTS:

1. PURPOSE OF THIS RESOLUTION. According to the author last year, both houses passed a similar measure, AJR 16 (Eduardo Garcia), Resolution Chapter 194, Statutes of 2015, on a bipartisan vote, however, recent events and a new FDA guideline make it important for the Legislature to go on record again on this issue. The author states that since 1983 the FDA policy, adopted when the scientific and medical community knew very little about human immunodeficiency virus (HIV) transmission, was a lifetime ban on blood donation for any men who had sex with men, however, last year, the FDA finally reconsidered, acknowledging that the policy was not in line with current scientific understanding and was unnecessarily discriminatory. The author notes in spite of overwhelming scientific evidence to the contrary, instead of an individual “risk-assessment” approach, the FDA adopted an arbitrary one year ban. In late July, the FDA announced that it is officially reconsidering the blood donations policy and has put out a formal request for public comment. The request specifically states that the FDA wants to ensure that the policy reflects the most up-to-date scientific knowledge. The author concludes that the purpose of this resolution is to put the California Legislature on record with the FDA urging a scientific-based, individual risk assessment policy.
   
2. BACKGROUND.
   
   1. Revised Recommendations for Reducing the Risk of HIV Transmission by Blood and Blood Products. The FDA recommends that blood establishments defer potential donors as follows:
      
      1. Defer indefinitely an individual who has ever had a positive test for HIV;
      2. Defer indefinitely an individual who has ever exchanged sex for money or drugs;
      3. Defer for 12 months from the most recent contact any individual who has a history of sex with a person who: has ever had a positive test for HIV; ever exchanged sex for money or drugs; or, ever engaged in non-prescription injection drug use;
      4. Defer for 12 months from the most recent transfusion any individual who has a history of receiving a transfusion of Whole Blood or blood components donated by another person;
      5. Defer for 12 months the most recent exposure any individual who has a history of through-the-skin contact with the blood of another individual, such as a needle stick or blood contact with an open wound or mucous membrane;
      6. Defer for 12 months from the most recent tattoo, ear or body piercing;
      7. Defer for 12 months after completion of treatment of any individual with a history of syphilis or gonorrhea or with a history of diagnosis or treatment for syphilis or gonorrhea in the past 12 months;
      8. Defer for 12 months from the most recent contact a man who has had sex with another man during the past 12 months; and,
      9. Defer for 12 months from the most recent contact a female who has had sex during the past 12 months with a man who has had sex with another man in the past 12 months.
   2. Technological Advances in Blood Testing. One important factor in developing blood donation deferral policies is the length of what is called the window period. The window period is the time span between when a person contracts HIV and when an HIV test can detect the virus within the person’s body.
      
      There are two main types of tests which can be used to test blood for HIV: the antibody test and the nucleic acid test (NAT). The antibody test assesses whether any HIV-targeted antibodies are in a person’s body. The NAT test looks for HIV in the blood. The NAT test is what is generally used to test donated blood because it has a shorter window period than the antibody test does. For most people, the window period for the antibody test is between two to eight weeks with an average of 25 days. Meanwhile, the window period for the NAT test is only nine to 11 days long.
      
      In part because of recent advances in testing technology, the risk of transmitting HIV through blood donation has decreased to one in 1.47 million. Since the NAT test can detect HIV in blood samples within such a short span of time, this diminishes the need for a yearlong ban on MSM. Instead, the deferral period for individuals who have been deemed high-risk through a risk-assessment test can be reduced to a shorter time span. Only those who have participated in high-risk activity would be deferred, and the time for which they would be deferred would be based on advancements in the technology used to test donated blood.
      
   3. Individual risk-assessment. The individual risk-assessment approach would evaluate the risk-level of behaviors of potential donors instead of banning entire “at-risk” groups from donating, such as MSM. Some higher risk activities which could be screened for using this model are whether or not a potential donor has engaged in unprotected anal sex, had sex with a person of an unknown HIV status in the past three months, or has had unprotected sex with multiple partners in the past three months, amongst other potentially risky behaviors. While this list of risky sexual acts can apply to the MSM community, it also demonstrates that heterosexual donors could be engaging in high-risk sexual or recreational activity which puts them at a greater risk of contracting HIV. Having blanket deferral policies not only spreads a false misconception that heterosexual sex is safe from HIV exposure, but it also does not educate donors about what behaviors put one at a greater risk. Adding these risk assessment questions further protects the blood supply because it bans high-risk activities that any donor, no matter their race, sexual orientation, or gender, could partake in.
      
   4. Current FDA process for reevaluating blood donor deferral policies. On July 26, 2016, the FDA issued a notice in the Federal Register titled “Blood Donor Deferral Policy for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products.” FDA issued a Final Guidance in December 2015 that changed the decades-old indefinite blood donor deferral policy regarding MSM to a one-year deferral since the last sexual contact with another man.

This change better aligns the deferral period with that of other men and women engaging in behaviors that place them at increased risk for HIV infection (e.g., those who had a recent blood transfusion or accidental exposure to the blood of another individual, or had other potential exposure to a potentially blood borne disease). When this policy was updated in 2015, the FDA promised to continue to reconsider the donor deferral policies as new data become available. The FDA is seeking science-based comments to the newly opened docket on:

• • 1. The feasibility of moving from the existing time-based deferrals related to risk behaviors to alternate deferral options, such as the use of individual risk assessment;
    2. The design of potential studies to evaluate the feasibility or effectiveness of such alternative deferral policy options; and,
    3. Other science-based comments that will help shape future decisions.

The public docket will be open for comments until November 25, 2016.

1. SUPPORT. Equality California (EQCA) is the sponsor of this resolution and states that when more than 50 people were injured in the shooting at the Pulse nightclub in Orlando in June of this year, thousands of gay and bisexual men nationwide came forward to donate blood to help members of their own community, but were turned away. EQCA notes it should not have taken this tragedy to call attention to the stigmatizing and unnecessary FDA policy still in place, which does not reflect modern detection methods of HIV.
   
   AIDS Project Los Angeles points out currently medical technology can identify within seven to 10 days with 99.9% accuracy whether or not a blood sample is HIV-positive and the chance of a blood test being inaccurate within the 10-day window is approximately one in 2 million.
2. PREVIOUS LEGISLATION. AJR 16 called upon the President of the United States to encourage the Secretary of the HHS to adopt policies to repeal the current and upcoming discriminatory donor suitability policies of the FDA regarding blood donations by men who have had sex with another man and, instead, direct the FDA to develop science-based policies such as criteria based on risky behavior in lieu of sexual orientation.

REGISTERED SUPPORT / OPPOSITION:

Support
Equality California (sponsor)
AIDS Project Los Angeles
AIDS Services Foundation Orange County

Opposition
None on file.

Analysis Prepared by: Lara Flynn / HEALTH / (916) 319-2097

 THIRD READING 

Bill No: SJR 26

Author: De León (D), et al.

Amended: 8/9/16

Vote: 21

SUBJECT: Blood donations

SOURCE: Author

DIGEST:

This resolution calls upon the President of the United States to encourage the Secretary of the United States Department of Health and Human Services (HHS) to adopt policies to repeal the current discriminatory donor suitability policies of the United States Food and Drug Administration (FDA) regarding blood donations by men who have had sex with another man and, instead, direct the FDA to develop science-based policies such as criteria based on risky behavior in lieu of sexual orientation.

Senate Floor Amendments of 8/9/16 add a provision relating to the FDA’s blood donor deferral policies, make a technical change, and add coauthors.

ANALYSIS: This resolution makes the following legislative findings:

1. Since 1983, the FDA, an agency under the HHS, had prohibited the donation of blood by any man who has had sex with another man (MSM) at any time since 1977.
2. In December 2015, based on recommendations from the HHS Advisory Committee on Blood and Tissue Safety and Availability, the FDA promulgated revised regulations to allow an MSM to donate blood only if he has not been sexually active for the past 12 months. Despite these recent steps toward a policy change, a double standard would still exist under the policy as it is proposed to be revised because it would still treat gay and bisexual men differently from heterosexual men.
3. The FDA currently does not allow gay and bisexual men in committed relationships to donate blood because, while one partner may be monogamous, that individual cannot guarantee that the other partner is monogamous. The FDA does not apply this same logic to heterosexual relationships, which in effect discriminates against gay and bisexual men.
4. The FDA is in the process of again reevaluating and considering updating its blood donor deferral policies as new scientific information becomes available, including the feasibility of moving from the existing time-based deferrals related to risk behaviors to alternate deferral options, such as the use of individual risk assessments.
5. The American Public Health Association has stated that no specific scientific rationale is provided to justify the 12-month deferral policy. The technology can identify within 7 to 10 days with 99.9 percent accuracy whether or not a blood sample is HIV-positive, and the chance of the blood test being inaccurate within the 10-day window is about 1 in 2,000,000.
6. The Williams Institute of the University of California at Los Angeles School of Law estimates that, based on the population of eligible and likely donors among the MSM community, lifting the federal lifetime deferral policy on blood donation by an MSM would result in 4.2 million newly eligible male donors, of which 360,600 would likely donate, generating 615,300 additional pints of blood. Applying national estimates to the California population, the Institute further estimates that lifting the ban on MSM blood donations would add an additional 510,000 eligible men to the current blood donor pool, of which 43,917 would likely donate, resulting in an additional 74,945 donated pints in California.

This resolution calls upon the President of the United States to encourage the Secretary of the United States Department of Health and Human Services to adopt policies to repeal the current discriminatory donor suitability policies of the FDA regarding blood donations by men who have had sex with another man and, instead, direct the FDA to develop science-based policies such as criteria based on risky behavior in lieu of sexual orientation.

Background

Technological Advances in Blood Testing. One important factor in developing blood donation deferral policies is the length of the window period. The window period is the time span between when a person contracts HIV and when an HIV test can detect the virus within the person’s body.

There are two main types of tests which can be used to test blood for HIV: the antibody test and the nucleic acid test (NAT). The antibody test assesses whether any HIV-targeted antibodies are in a person’s body. The NAT test looks for HIV in the blood. The NAT test is what is generally used to test donated blood because it has a shorter window period than the antibody test does. For most people, the window period for the antibody test is between two to eight weeks with an average of twenty-five days. Meanwhile, the window period for the NAT test is only nine to 11 days long.

In part because of recent advances in testing technology, the risk of transmitting HIV through blood donation has decreased to 1 in 1.47 million. Since the NAT test can detect HIV in blood samples within such a short span of time, this diminishes the need for a yearlong ban on MSM. Instead, the deferral period for individuals who have been deemed high-risk through a risk-assessment test can be reduced to a shorter timespan. Only those who have participated in high-risk activity would be deferred, and the time for which they would be deferred would be based on advancements in the technology used to test donated blood.

Comments

Why support a risk-assessment approach? According to the author:

An individual risk-assessment approach would evaluate the risk-level of behaviors of potential donors instead of banning entire “at-risk” groups from donating, such as MSM. Some higher risk activities which could be screened for using this model are whether or not a potential donor has engaged in unprotected anal sex, had sex with a person of an unknown HIV status in the past three months, or has had unprotected sex with multiple partners in the past three months, amongst other potentially risky behaviors.

While this list of risky sexual acts can apply to the MSM community, it also demonstrates that heterosexual donors could be engaging in high-risk sexual or recreational activity which puts them at a greater risk of contracting HIV. Having blanket deferral policies not only spreads a false misconception that heterosexual sex is safe from HIV exposure, but it also does not educate donors about what behaviors put one at a greater risk. Adding these risk assessment questions further protects the blood supply because it bans high-risk activities that any donor, no matter their race, sexual orientation, or gender, could partake in.

Prior Legislation

AJR 16 (Eduardo Garcia, Resolution Chapter 194, Statutes of 2015) called upon the President of the United States to encourage the Secretary of the HHS to adopt policies to repeal the current and upcoming discriminatory donor suitability policies of the FDA regarding blood donations by men who have had sex with another man and, instead, direct the FDA to develop science-based policies such as criteria based on risky behavior in lieu of sexual orientation.

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

SUPPORT: (Verified 8/5/16)

APLA Health

Access Support Network of San Luis Obispo and Monterey Counties

Equality California

Project Inform

OPPOSITION: (Verified 8/5/16)

None received

Prepared by: Karen Chow / SFA / (916) 651-1520

8/10/16 15:40:28

**** END ****

 THIRD READING 

Bill No: SJR 26

Author: De León (D), et al.

Introduced: 8/3/16

Vote: 21

SUBJECT: Blood donations

SOURCE: Author

DIGEST:

This resolution calls upon the President of the United States to encourage the Secretary of the United States Department of Health and Human Services (HHS) to adopt policies to repeal the current discriminatory donor suitability policies of the United States Food and Drug Administration (FDA) regarding blood donations by men who have had sex with another man and, instead, direct the FDA to develop science-based policies such as criteria based on risky behavior in lieu of sexual orientation.

ANALYSIS: This resolution makes the following legislative findings:

1. Since 1983, the FDA, an agency under the HHS, had prohibited the donation of blood by any man who has had sex with another man (MSM) at any time since 1977.
2. In December 2015, based on recommendations from the HHS Advisory Committee on Blood and Tissue Safety and Availability, the FDA promulgated revised regulations to allow an MSM to donate blood only if he has not been sexually active for the past 12 months. Despite these recent steps toward a policy change, a double standard would still exist under the policy as it is proposed to be revised because it would still treat gay and bisexual men differently from heterosexual men.
3. The FDA does not allow gay and bisexual men in committed relationships to donate blood because, while one partner may be monogamous, that individual cannot guarantee that the other partner is monogamous. The FDA does not apply this same logic to heterosexual relationships, which in effect discriminates against gay and bisexual men.
4. The American Public Health Association has stated that no specific scientific rationale is provided to justify the 12-month deferral policy. The technology can identify within 7 to 10 days with 99.9 percent accuracy whether or not a blood sample is HIV-positive, and the chance of the blood test being inaccurate within the 10-day window is about 1 in 2,000,000.
5. The Williams Institute of the University of California at Los Angeles School of Law estimates that, based on the population of eligible and likely donors among the MSM community, lifting the federal lifetime deferral policy on blood donation by an MSM would result in 4.2 million newly eligible male donors, of which 360,600 would likely donate, generating 615,300 additional pints of blood. Applying national estimates to the California population, the Institute further estimates that lifting the ban on MSM blood donations would add an additional 510,000 eligible men to the current blood donor pool, of which 43,917 would likely donate, resulting in an additional 74,945 donated pints in California.

This resolution calls upon the President of the United States to encourage the Secretary of the United States Department of Health and Human Services to adopt policies to repeal the current discriminatory donor suitability policies of the FDA regarding blood donations by men who have had sex with another man and, instead, direct the FDA to develop science-based policies such as criteria based on risky behavior in lieu of sexual orientation.

Background

Technological Advances in Blood Testing. One important factor in developing blood donation deferral policies is the length of the window period. The window period is the time span between when a person contracts HIV and when an HIV test can detect the virus within the person’s body.

There are two main types of tests which can be used to test blood for HIV: the antibody test and the nucleic acid test (NAT). The antibody test assesses whether any HIV-targeted antibodies are in a person’s body. The NAT test looks for HIV in the blood. The NAT test is what is generally used to test donated blood because it has a shorter window period than the antibody test does. For most people, the window period for the antibody test is between two to eight weeks with an average of twenty-five days. Meanwhile, the window period for the NAT test is only nine to 11 days long.

In part because of recent advances in testing technology, the risk of transmitting HIV through blood donation has decreased to 1 in 1.47 million. Since the NAT test can detect HIV in blood samples within such a short span of time, this diminishes the need for a yearlong ban on MSM. Instead, the deferral period for individuals who have been deemed high-risk through a risk-assessment test can be reduced to a shorter timespan. Only those who have participated in high-risk activity would be deferred, and the time for which they would be deferred would be based on advancements in the technology used to test donated blood.

Comments

Why support a risk-assessment approach? According to the author:

An individual risk-assessment approach would evaluate the risk-level of behaviors of potential donors instead of banning entire “at-risk” groups from donating, such as MSM. Some higher risk activities which could be screened for using this model are whether or not a potential donor has engaged in unprotected anal sex, had sex with a person of an unknown HIV status in the past three months, or has had unprotected sex with multiple partners in the past three months, amongst other potentially risky behaviors.

While this list of risky sexual acts can apply to the MSM community, it also demonstrates that heterosexual donors could be engaging in high-risk sexual or recreational activity which puts them at a greater risk of contracting HIV. Having blanket deferral policies not only spreads a false misconception that heterosexual sex is safe from HIV exposure, but it also does not educate donors about what behaviors put one at a greater risk. Adding these risk assessment questions further protects the blood supply because it bans high-risk activities that any donor, no matter their race, sexual orientation, or gender, could partake in.

Prior Legislation

AJR 16 (Eduardo Garcia, Resolution Chapter 194, Statutes of 2015) called upon the President of the United States to encourage the Secretary of the HHS to adopt policies to repeal the current and upcoming discriminatory donor suitability policies of the FDA regarding blood donations by men who have had sex with another man and, instead, direct the FDA to develop science-based policies such as criteria based on risky behavior in lieu of sexual orientation.

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

SUPPORT: (Verified 8/5/16)

APLA Health

Access Support Network of San Luis Obispo and Monterey Counties

Equality California

Project Inform

OPPOSITION: (Verified 8/5/16)

None received

Prepared by: Karen Chow / SFA / (916) 651-1520

8/5/16 14:34:31

**** END ****