New Jersey has become the first state in the United States to adopt a comprehensive regulatory framework for facilities that store human embryos. The new rules, announced by the New Jersey Department of Health, set clear standards for licensing and oversight of sites offering storage and preservation of eggs and embryos used in assisted reproductive technology.
The use of reproductive medicine and technology has increased in recent years. In 2022, fertility clinics in New Jersey performed nearly 13,000 assisted reproductive technology procedures, resulting in more than 5,500 live births, according to data from the Centers for Disease Control and Prevention. Until now, oversight of egg and embryo storage relied on a mix of federal agency guidelines and voluntary professional standards without specific state-level regulation.
The new regulations aim to address this gap by establishing requirements intended to ensure facility safety, promote consistent equipment operation, and prepare sites for emergencies or natural disasters.
“Today we are setting a national standard for safe embryo storage. Receiving fertility services can be an emotional and transformative process for New Jersey residents trying to build a family. The last thing patients receiving fertility services should have to worry about is whether their eggs and embryos are being stored properly,” said Governor Phil Murphy. “By establishing clear regulations, we are holding embryo storage facilities in New Jersey to a higher standard and ensuring that 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 build their families as they go through one of the most significant and challenging periods of their lives.”
Regulated facilities include reproductive laboratories, IVF clinics, reproductive medicine clinics, hospitals or other locations that store or cryopreserve human eggs or embryos.
Under the new rules, facilities must apply for licenses and comply with standards related to equipment safety and maintenance, emergency preparedness, quality management, record-keeping, and reporting. Except for licensed health care providers who store fresh human eggs or embryos onsite for assisted reproduction use, facilities must be accredited by either the College of American Pathologists’ Reproductive Accreditation Program or The Joint Commission’s Laboratory or Office-Based Surgery Accreditation Programs. They must also register with the U.S. Food & Drug Administration (FDA) as Human Cells & Tissue Establishments (HCT/P) if applicable.
Key provisions include requirements for physical plant safety such as backup power systems; oxygen sensors where liquid nitrogen is used; remote alarm systems on cryogenic storage equipment; written policies regarding disposition of reproductive tissue under certain circumstances like facility closure or client death; annual license renewal; reporting requirements related to equipment failures or emergencies affecting stored tissue; and maintaining certain records for at least ten years after release.
These regulations were developed with input from an advisory panel including experts in embryology, biobanking management, reproductive medicine operations, laboratory practice, and reproductive rights advocacy.
The rules took effect with publication in the December 15th edition of the New Jersey Register. Facilities currently operating must notify the Department in writing by January 15th about their intent to apply for a license and submit applications before February 13th. Accredited facilities providing proper notice will receive provisional licenses while applications are reviewed.
The standards implement requirements established by legislation signed into law on December 4th 2019 (P.L. 2019 c.268), later amended by P.L. 2022 c.106.
