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S 2869Public Health

Health and Safety - Embryo Safety and Storage Act

Facilities storing human embryos must get a state license, follow safety rules, and undergo inspections to operate legally.

Introduced
Population
Affected
15
Email Legislator
Introduced Mar 4, 2026Committee Senate Health & Human Services

Plain-English Summary

This legislation establishes the "Embryo Safety and Storage Act." It mandates that any facility in Rhode Island storing human eggs, pre-embryos, or embryos for reproductive purposes must obtain a license from the Department of Health. The Department is directed to create specific safety and operational rules based on national standards and conduct inspections. The bill also sets penalties for operating without a license, including fines and potential prison time. It aims to prevent the loss of specimens due to storage failures or disasters.

For younger readers

This bill helps protect families who are trying to have babies. Doctors sometimes save tiny cells called eggs or embryos to help people become parents later. This law says that the buildings where these cells are kept must follow strict safety rules so the cells don't get lost or damaged by accidents or power outages. The government will visit these places to make sure they are safe. If a place breaks the rules or doesn't have a special permission slip called a license, they can get in big trouble.

Who & Where It Applies

Impacted groups
Couples using IVFFertility clinicsEmbryo storage facilitiesDepartment of Health employeesReproductive endocrinologists
Impacted communities
All

Constitutional & Fiscal Check

The bill authorizes the Department of Health to inspect facilities and records "without prior notice." While the Supreme Court permits warrantless administrative searches of "closely regulated industries," this provision could potentially be challenged under the Fourth Amendment if deemed unreasonable or if the industry isn't considered historically regulated enough to warrant the exception. However, given the medical nature, it is likely to survive scrutiny.

Estimated cost
Amount unknown
Estimated revenue
Amount unknown

Bill Analysis

Both viewpoints
For Progressives
  • Protects vulnerable patients seeking reproductive assistance by establishing strict safety standards for the storage of genetic material, preventing emotional and financial devastation due to negligence.
  • Validates and supports assisted reproductive technology as a crucial pathway to parenthood, adhering to the belief that healthcare systems should robustly support diverse family planning methods.
  • Increases government oversight of private medical facilities, ensuring that profit motives do not compromise the safety and integrity of essential medical services.
  • May increase the cost of IVF and reproductive services for patients, as facilities pass on the expenses of new licensing fees, compliance, and infrastructure upgrades to consumers.
  • Imposes felony criminal penalties and prison time for licensing violations, which may be viewed as contributing to mass incarceration rather than utilizing restorative or administrative justice measures.
  • Could result in the closure of smaller, independent fertility clinics that cannot afford the regulatory compliance costs, potentially reducing access to care in underserved areas.
For Conservatives
  • Ensures the protection and dignified treatment of human embryos and pre-embryos, aligning with values regarding the sanctity of potential human life.
  • Imposes strict penalties, including felonies, on bad actors who operate fraudulently or negligently, upholding the rule of law and accountability in business practices.
  • Protects families who have invested significant financial resources into starting a family from being defrauded or harmed by negligent service providers.
  • Expands the size and scope of state government by creating a new licensing regime, granting the Department of Health broad authority to inspect private businesses without prior notice.
  • Imposes new regulatory burdens and fees on private medical practices and businesses, which contradicts the principle of free enterprise and deregulation.
  • Grants the state the power to shut down businesses and seize records, potentially infringing on the autonomy of private entities and the privacy of their clients.

Votes

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Full Bill Text

Changes to existing Rhode Island law · 108 additions

SECTION 1. Findings of fact. The general assembly finds as follows:

(1) In vitro fertilization, commonly known as IVF, is a widely used method of assisted reproductive technology (ART). ART has helped an estimated six million (6,000,000) couples in the United States who have trouble getting or maintaining a pregnancy start families.

(2) IVF provides a pathway for people to parenthood.

(3) It is in the best interest of the people of this state to direct the department of health to promulgate rules and regulations governing the storage of human eggs, pre-embryos, and embryos in embryo storage facilities to guard against catastrophic storage system failure and the potential loss of such specimens that may result from long-term power outages during storms and other natural disasters.

SECTION 2. Title 23 of the General Laws entitled "HEALTH AND SAFETY" is hereby amended by adding thereto the following chapter: 23-13.9-1. Title. This act shall be known as and may be cited as the “Embryo Safety and Storage Act.” 23-13.9-2. Definitions. As used in this chapter, the following terms shall have the following meanings, unless the context clearly indicates otherwise:

(1) "Department" means the Rhode Island department of health.

(2) "Director" means the director of the Rhode Island department of health.

(3) "Embryo storage facility" means a facility which cryopreserves and stores human eggs, pre-embryos, and embryos for later use in in vitro fertilization, embryo transfer, gamete transfer, pronuclear stage transfer and zygote transfer, and other procedures performed to achieve a pregnancy or pregnancies. Embryo storage facility shall also include the office of a licensed health care provider which stores human eggs, pre-embryos, or embryos.

(4) "Person" means any individual, corporation, company, association, organization, society, firm, partnership, joint stock company, or the state or any political subdivision thereof. 23-13.9-3. Prohibited activities.

(a) No person shall conduct, maintain, or operate an embryo storage facility in this state unless licensed by the department pursuant to the provisions of this chapter. A separate license shall be required for each embryo storage facility location. The license shall be posted and displayed at all times in a prominent location within the facility. No license issued pursuant to this chapter shall be transferable. A change in the ownership of the facility shall require notification to the department within fourteen (14) calendar days and reapplication for licensure.

(b) The department shall not license a person to conduct, maintain, or operate an embryo storage facility pursuant to this chapter unless the department is satisfied that the person has demonstrated good character, competency, and integrity, and has furnished such information to the director as the director may require for this purpose. 23-13.9-4. Rules and regulations.

(a) The department shall promulgate rules and regulations governing the storage and care of human eggs, pre-embryos, and embryos by an embryo storage facility in accordance with:

(1) Standards ISO 9001 and ISO 20387 of the International Organization for Standardization;

(2) Standards for biorepositories established by the College of American Pathologists Biorepository Accreditation Program; and

(3) The U.S. Food and Drug Administration guidance on current good tissue practices.

(b) The rules and regulations authorized by this section shall promote safety and best practices among embryo storage facilities and, at a minimum prescribe standards governing the operation, maintenance, and administration of embryo storage facilities the safety and adequacy of the physical plant or the facilities compliance with state and local fire safety codes the number of staff and the qualifications of each staff member, the protection and safety of the equipment used by embryo storage facilities to process and store human eggs, pre-embryos, and embryos, the maintenance and confidentiality of records and furnishing of required information, the maintenance of all appropriate accreditations and the establishment of a quality management program the review of the scope of internal audits.

(c) The department shall conduct an on-site facility inspection and shall evaluate the embryo storage facility to determine whether the facility complies with the provisions of this chapter.

(d) The department shall have the authority to inspect and examine the physical plant or facilities of an embryo storage facility and to inspect all documents, records, files, or other data maintained pursuant to this chapter during normal operating hours and without prior notice.

(e) The department shall request the appropriate state and local fire, health, and building officials to conduct examinations and inspections to determine compliance with state and local ordinances, codes, and regulations by an embryo storage facility. The inspections shall be conducted and the results reported to the department within sixty (60) days after the request.

(f) If an embryo storage facility meets the requirements of this chapter and the rules and regulations promulgated hereunder, the department shall issue a license to the facility. A license shall be valid for a period of one year and may be renewed at the end of that period, subject to continued compliance with the provisions of this of this chapter.

(g) All rules and regulations promulgated pursuant to this chapter shall be adopted and amended in accordance with chapter 35 of title 42 ("administrative procedures"). 23-13.9-5. Licensing of active facilities.

(a) Any person operating an embryo storage facility on or after the effective date of this chapter or desiring to operate an embryo storage facility shall make application for licensure in the manner and on the forms prescribed by the director. The license application form shall include, but shall not be limited to, the following information:

(1) The name and address of the embryo storage facility, the operator of the facility, and the staff;

(2) The qualifications of the staff members, each member of the board of directors of the corporation, and the embryo storage facility operator; a description of the facility's premises and facilities and the hours of its operation; and

(3) Any other information the director deems necessary to include on the license application form.

(b) If an embryo storage facility meets the requirements of this chapter and of the rules and regulations promulgated hereunder, the department shall issue a license to the facility. A license shall be valid for a period of one year and may be renewed at the end of that period, subject to continued compliance with the provisions of this chapter. 23-13.9-6. Fees.

(a) The director shall establish a minimum fee to be paid by each embryo storage facility at the time of application for a license and at every renewal of a license.

(b) The income received from licensure and renewal fees pursuant to this section shall be appropriated to the department to effectuate the purposes of this chapter. 23-13.9-7. License revocation. The department may deny, suspend, revoke, or refuse to renew a license for good cause, including, but not limited to:

(1) Failure of an embryo storage facility or its operator to comply with the provisions of this chapter;

(2) Violation of the terms and conditions of a license by an embryo storage facility or its operator;

(3) Use of fraud or misrepresentation by an embryo storage facility or its operator in obtaining a license or in the subsequent operation of the facility;

(4) Refusal by an embryo storage facility or its operator to furnish the department with required files, reports, or records; or

(5) Refusal by an embryo storage facility or its operator to permit an inspection by an authorized representative of the department during normal operating hours. 23-13.9-8. Hearings.

(a) The department, before denying, suspending, revoking, or refusing to renew a license, shall give notice to the operator personally, or by certified or registered mail to the last known address of the operator with return receipt requested. The notice shall afford the operator with an opportunity to be heard in person or by an attorney, and to offer evidence pertinent to the subject of the hearing.

(b) The hearing shall take place within sixty (60) days from the issuance or mailing of the notice and shall be conducted in accordance with chapter 35 of title 42 ("administrative procedures"). 23-13.9-9. Acting without a license. Any person who operates or assists in the operation of an embryo storage facility which does not have a license, who has used fraud or misrepresentation in obtaining a license or in the subsequent operation of a facility, who offers, advertises, or provides any service not authorized by a valid license, or who violates any other provision of this chapter shall be guilty of a felony and upon conviction thereof, shall be subject to a fine of up to five thousand dollars ($5,000), or imprisonment for a period of up to two (2) years, or both.

SECTION 3. This act shall take effect on January 1, 2027.