New Jersey Sets National Standard with First-of-a-Kind Embryo Storage Regulations

Comprehensive New Rules Protect Families and Ensure Safety of Stored Reproductive Tissue

TRENTON, NJ - The New Jersey Department of Health today adopted the nation's first comprehensive state regulatory framework for human embryo storage facilities. The rules create clear standards for the licensure and oversight of facilities that offer storage and/or cryopreservation of eggs and embryos used in assisted reproductive technology.

The use of reproductive medicine and technology has increased significantly in recent years. In 2022, New Jersey fertility clinics performed nearly 13,000 assisted reproductive technology procedures, resulting in more than 5,500 live birth deliveries, according to the Centers for Disease Control and Prevention. Yet oversight of egg and embryo storage in New Jersey and across the country relies on a patchwork of federal agencies and voluntary professional organization standards, with no state-level regulatory framework specifically governing these facilities.

New Jersey's new rules address this gap by establishing requirements that will help ensure the safety of embryo storage facilities, promote the effective and consistent operation of equipment, and ensure that facilities are prepared for emergencies and natural disasters.

"Today, we are setting a national standard for safe embryo storage. Undergoing fertility services can be an emotional and life-altering process for New Jerseyans trying to start a family. The last thing patients undergoing fertility services should have to worry about is whether their eggs and embryos are stored correctly," said Governor Phil Murphy. "By setting clear regulations, we are holding embryo storage facilities in New Jersey to a higher standard and ensuring patients focus on what matters most in their pursuit of parenthood."

"The decision to pursue fertility treatment is deeply personal, and New Jerseyans deserve to know that the facilities storing their eggs and embryos meet rigorous standards," said Acting Health Commissioner Jeff Brown. "With these rules, New Jersey is setting a national benchmark for protecting people hoping to start or grow their families as they navigate one of the most significant and complicated periods in their lives."

Embryo storage facilities regulated by the rules include reproductive laboratories, in-vitro fertilization clinics, reproductive medicine practices, hospitals, or other facilities that store or cryopreserve human eggs or embryos.

Under the rules, facilities that store human eggs and embryos must apply for licensure and follow certain standards, including for equipment safety and maintenance, emergency preparedness, quality management, recordkeeping, and reporting. Facilities, except licensed health care providers that store fresh human eggs or embryos onsite for use in assisted reproductive technology, must be accredited by either the College of American Pathologists' Reproductive Accreditation Program or the Joint Commission on Accreditation of Healthcare Organizations' Laboratory or Office-Based Surgery Accreditation Programs. Those required to register with the U.S. Food and Drug Administration as a Human Cell and Tissue (HCT/P) Establishment must demonstrate current registration.

The rules were developed with input from an advisory panel of experts in embryology, biobanking management, reproductive medicine, laboratory operations, and reproductive rights. Key provisions include:

• Standards for physical plant safety, including backup power systems and oxygen sensors in rooms where liquid nitrogen is used;
• Requirements for remote alarm systems on cryogenic storage equipment;
• Mandatory written policies addressing disposition of reproductive tissue in circumstances including facility closure, client death or incapacity, and nonpayment of storage fees;
• Annual licensure and renewal requirements;
• Reporting requirements for equipment failures, errors, and emergencies that could affect stored reproductive tissue; and
• Recordkeeping requirements including maintenance of certain records for at least 10 years after the reproductive tissue is released for use.

Through these regulations, the Department aims to give individuals and couples that utilize assisted reproductive technology greater confidence in the integrity of stored reproductive tissue and its availability for their future use or benefit. The standards also aim to decrease the probability of avoidable equipment failure that have in the past resulted in catastrophic storage system failure in facilities located in other states.

The rules became effective with the publication of a Notice of Adoption in the December 15, 2025, New Jersey Register. Under the rules, embryo storage facilities currently operating in New Jersey must provide written notice of their intention to apply for a license to the Department by January 15, 2026, and submit their application for licensure by February 13, 2026. Facilities that are accredited, in good standing, and timely provide the requisite written notice to the Department will be deemed to have provisional licensure to continue operations while their applications are being reviewed.

The rules implement requirements established by P.L. 2019, c. 268, signed into law on December 4, 2019, and amended by P.L. 2022, c. 106.

For more information about the Biobanking Compliance Program and embryo storage facility licensure, visit https://www.nj.gov/health/phel/clinical-lab-imp-services/biobanking-compliance/