The New Jersey Department of Health has adopted the country’s first comprehensive state regulations for human embryo storage facilities. These new rules set standards for licensing and oversight of sites that store or cryopreserve eggs and embryos used in assisted reproductive technology.
In recent years, the use of reproductive medicine has grown. According to the Centers for Disease Control and Prevention, nearly 13,000 assisted reproductive technology procedures were performed at New Jersey fertility clinics in 2022, resulting in more than 5,500 live birth deliveries. Previously, oversight of egg and embryo storage was managed by a mix of federal agencies and voluntary professional standards without a dedicated state-level regulatory framework.
The new regulations aim to address this gap by requiring safety measures for embryo storage facilities. The requirements include proper equipment operation, emergency preparedness plans, and readiness for natural disasters.
Governor Phil Murphy stated, “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. 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.”
Acting Health Commissioner Jeff Brown said, “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. 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.”
Facilities covered under these rules include reproductive laboratories, IVF clinics, hospitals, or other locations that store or freeze human eggs or embryos. They must now apply for licensure from the state health department and follow standards related to equipment safety and maintenance, emergency planning, quality management systems, recordkeeping practices, and reporting protocols.
Most facilities—excluding licensed health care providers storing fresh tissue onsite—are required to hold accreditation from either the College of American Pathologists’ Reproductive Accreditation Program or Joint Commission programs related to laboratory or surgery accreditation. Those registered with the U.S. Food and Drug Administration as Human Cell and Tissue Establishments must show proof of current registration.
Development of these rules involved input from experts in embryology, biobanking management, reproductive medicine operations, laboratory practices, and reproductive rights advocacy.
Key provisions include:
– Safety standards such as backup power systems and oxygen sensors where liquid nitrogen is used
– Remote alarm systems on cryogenic storage units
– Written policies on how reproductive tissue will be handled if a facility closes or if clients die or become incapacitated
– Annual license renewal
– Reporting obligations regarding equipment failures or emergencies affecting stored tissue
– Record retention requirements extending ten years after tissue release
The Department hopes these measures will provide individuals using assisted reproduction greater confidence that their genetic material is secure while also reducing chances of equipment failures similar to those reported at out-of-state facilities.
The rules became effective upon publication in the December 15 edition of the New Jersey Register. Existing embryo storage sites must notify the Department by January 15 about their intention to apply for licenses; full applications are due by February 13. Facilities meeting accreditation criteria that submit timely notice will receive provisional licenses during review.
These regulations implement requirements established under laws signed in December 2019 (P.L. 2019 c.268) with amendments added in July 2022 (P.L. 2022 c.106).
