These new provisions of law are intended to establish a parent-child relationship where the child or children is/are conceived through assisted reproduction (“Child”), and a gestational surrogate, an adult who is not an intended parent, enters into a surrogacy agreement to bear the Child resulting from an embryo formed using gametes other than the surrogate’s. The Legislature directed the Department to regulate surrogacy programs and assisted reproduction service providers, the practice of gestational surrogacy, and the donation of ova to ensure the health and safety of the surrogate, the egg donor and the Child born under gestational surrogacy agreements, to ensure that the surrogacy agreement is ethical, and to ensure that surrogacy agreements are fair to the parties that enter into them.

This regulation provides a process for the licensing of surrogacy programs, the registration of gestational surrogacy assisted reproduction service providers, and the creation of a surrogacy registry and an ova registry. This regulation also implements the requirements for the Department of Health to establish gestational surrogacy guidelines and ova donation guidelines.

Statutory Authority:

Section 1404 of the General Business Law directs the Department of Health (Department) to promulgate regulations to implement the requirements of General Business Law Article 44 by regulating surrogacy programs and assisted reproduction service providers.

Section 2599-cc of the Public Health Law directs the Department to promulgate regulations on the practice of gestational surrogacy.

Section 4365(4) of the Public Health Law directs the Department to promulgate regulations on the donation of ova.

Legislative Objectives:

Part L of Chapter 56 of the Laws of 2020, among other things, added Article 5 C to the Family Court Act (judgments of parentage of children conceived through assisted reproduction or pursuant to surrogacy agreements), amended Public Health Law Article 42 (vital statistics), added a new Article 44 to the General Business Law (regulation of surrogacy programs and assisted reproduction service providers), added a new Article 25-B to the Public Health Law (gestational surrogacy), and amended Public Health Law Article 43 (anatomical gifts).

These new provisions of law are intended to establish a child’s relationship to his or her parents where the child is conceived through assisted reproduction, and a gestational surrogate, an adult who is not an intended parent, enters into a surrogacy agreement to bear the child resulting from an embryo formed using eggs other than their own. The Legislature directed the Department to regulate surrogacy programs and assisted reproduction service providers, the practice of gestational surrogacy, and the donation of ova to ensure the health and safety of the surrogate, the egg donor and the children born under gestational surrogacy agreements, to ensure that the surrogacy agreement is ethical, and to ensure that surrogacy agreements are fair to the parties that enter into them.

Needs and Benefits:

Licensing and regulation of surrogacy programs and assisted reproduction service providers will protect the donors, surrogates, and the children who are born under gestational surrogacy agreements. There have been documented cases in which the owners of businesses that broker surrogacy agreements have misappropriated and absconded with client funds and otherwise inadequately or negligently administered their programs to the detriment of their clients, including the donors and surrogates. These licensure requirements for surrogacy programs in New York State will reduce incompetence and fraud in the operation of businesses that arrange gestational surrogacy agreements.

Gestational surrogacy provides an opportunity for New Yorkers to become parents despite circumstances in which pregnancy is either biologically not possible or medically contraindicated. Although gestational surrogacy increases opportunities for family building, it also involves medical, psychosocial, fiscal and ethical considerations, as well as legal complexities. These regulations provide a framework to address these important considerations and establish protections for gestational surrogates and intended parents.

Costs:

Costs to Regulated Parties:

Surrogacy programs will have to pay a $1,000 fee to become licensed and a $200 annual renewal fee, and they will incur the costs of becoming licensed. Assisted reproduction service providers are already regulated as health care providers, and this regulation will not increase their costs significantly.

It is entirely voluntary to enter into a surrogacy agreement, and this regulation will not significantly affect the cost of doing so. Rather, this regulation will help ensure that surrogacy agreements are commercially reasonable for payer and payee.

Costs to Local Governments:

Local governments will incur no costs under this regulation, as it will have no effect on the administration of local government.

Costs to the Department of Health:

The New York State Department of Health will devote the cost of approximately one grade 23 full time equivalent to the administration of this new program, which may be partially offset by the collection of surrogacy program licensing fees. The cost to the Department is the result of Laws of 2020, Chapter 56, Part L, not the implementation of the law with this regulation, which the Department is required to promulgate under Laws of 2020, Chapter 56, Part L.

Paperwork:

Individuals and entities wishing to become licensed as surrogacy programs under this regulation will be required to complete an application and provide information to the Department regarding their business. Surrogacy programs will be required to submit information to the Department in order for the Department to maintain the surrogacy registry, and assisted reproduction service providers will be required to register with the Department, submit information about the types and numbers of procedures performed in connection with gestational surrogacy agreements and submit information to the Department in order for the Department to maintain the ova donation registry. Such paperwork is the result of the Laws of 2020, Chapter 56, Part L, rather than these regulations.

Local Government Mandates:

This regulation imposes no mandates on local governments.

Duplication:

These regulatory amendments do not duplicate any New York State or federal rules.

Alternatives:

The alternative would be to not promulgate this regulation. However, this alternative would be contrary to Laws of 2020, Chapter 56, Part L, which requires the Department to promulgate this regulation. The regulation was written to impose the least burden on regulated parties and to reduce costs to the taxpayers, while protecting the health and safety of donors, surrogates, and the parties to surrogacy agreements, as well as the children who are born under surrogacy agreements.

Federal Standards:

There are no federal statutes or regulations that apply to the subject matter of this regulation.

Compliance Schedule:

The regulations will become effective upon publication of a Notice of Adoption in the New York State Register.

Changes made to the last published rule do not necessitate revision to the previously published Regulatory Flexibility Analysis, Rural Area Flexibility Analysis and Job Impact Statement.

As a rule that requires a RFA, RAFA or JIS, this rule will be initially reviewed in the calendar year 2024, which is no later than the 3rd year after the year in which this rule is being adopted.

The New York State Department of Health (the Department) received comments from entities and individuals regarding the proposed amendments to Title 10 of the New York Codes, Rules and Regulations that added a new Subpart 69-11, Surrogacy Programs and Assisted Reproduction Service Providers.

The proposed amendments implement provisions of the Child-Parent Security Act. The vast majority of the comments did not question the manner in which these regulations implemented the law. Rather, the comments proposed changes to the law itself, or in some cases changes to guidance and other informational material on the Department’s website. In the final rule, the Department is not making any substantive changes to the proposed regulation.