Add Embryo to Tissue Definition

1 Co-sponsor

• Gustavo Rivera

Title of bill

An act to amend the public health law, in relation to adding "embryo" to the definition of "tissue" for purposes of tissue storage

Summary of specific provision

Section 1 amends subdivision 10 of Section 4360 of the public health law to add "embryo" to the definition of tissues covered by the tissue bank and storage facility licensing law.

Section 2 establishes the effective date.

Justification

In vitro fertilization, commonly known as IVF, is an accepted and widely used method of assisted reproductive technology (ART). ART has helped an estimated six million couples in the United States who have trouble getting pregnant or maintaining a pregnancy start families. IVF provides a pathway to motherhood for women who have experienced life- threatening diseases, such as cancer, and the reproductive damage that is often a consequence of the treatments associated with these illnesses. It also provides the same pathway for couples, regardless of sex or sexual orientation, and is often a critical service to transgen- der individuals. It is anticipated that by the end of the century, more than a million American patients who suffer from some form of fertility issue will undergo IVF procedures.

The public interest in adequately protecting the human embryo tissue bank and storage facility industry is of the highest importance. Many populations depend on these facilities to protect their ability to have children. The safe, effective regulation of embryo tissue banks and storage facilities is critical to meeting this need. Under current law, embryos are not defined in the list of types of tissues that may be included in tissue bank and storage facilities. However, the New York State Department of Health includes embryos in their list of tissues that they regulate. This bill would add embryos to the definition of "tissue" under Section 4360 of the Public Health Law, thereby confirming the regulatory authority of the Department of Health in statute.

Additionally, Due to the increasing use of IVF and the advances in the science of embryo storage, the Commissioner of Health should consider modernizing and updating New York's regulations on embryo storage to incorporate new guidance including standards ISO 9001 and ISO 20387 of the International Organization for Standardization, the standards for biorepositories established by the International Society for Biological and Environmental Repositories and by the College of American Patholo- gists Biorepository Accreditation Program, and the FDA's guidance on "current good tissue practices."

These standards are accepted best practices for protection of embryos, as well as for protection of the public interest in these important facilities.

Prior legislative history

None.

Fiscal implications

None to the state.

Effective date

This act shall take effect immediately.