NJ on Cusp of Stringent Licensing, Oversight of Embryo Storage Facilities

Lilo H. Stainton | November 26, 2019 | Health Care
State officials would have until 2021 to adopt a system governing the 19 New Jersey facilities that store human eggs, embryos and other reproductive material
Credit: Pasi Maenpaa/Pixabay
Experts say that proper storage, labeling and handling of materials need to be regulated.

New Jersey will likely be the first state to require licensing and extensive regulation of embryo storage facilities, under legislation designed to avoid the fertility clinic failures that impacted some 1,400 families in California and Ohio in 2018.

The New Jersey Assembly voted with near unanimity Monday to approve legislation governing such facilities; the measure incorporated changes requested by Gov. Phil Murphy in a conditional veto he signed in August to provide state officials more time to get the unique program up and running. The Senate had already unanimously approved Murphy’s amendments in August, so the measure now returns to the governor for a final OK.

Under the Democratic-sponsored plan, the state Department of Health has until early 2021 to work with federal agencies and clinical experts to adopt a licensing and oversight system for the 19 Garden State facilities that store human eggs, embryos and other reproductive material used for in vitro fertilization and other procedures designed to produce a pregnancy. The original version gave them seven months to do this; Murphy’s changes extended this to 14.

The health department will then need to inspect each facility to ensure it meets these new state requirements for storing, labeling and handling the approximately 100,000 samples now under their control, among other things, before issuing the storage sites an annual license.

“Families attempting to conceive face a number of physical and emotional challenges,” said Assemblywoman Pamela Lampitt (D-Camden), a lead sponsor of the bill. Assembly Democrats said it is the first of its kind to require this level of state oversight for embryo storage facilities, which currently must meet state business and local zoning regulations but are not subject to specific guidelines.

“They put their hopes and dreams of conceiving into the embryos stored in these facilities,” Lampitt added. “To have those dreams shattered due to a preventable operating failure is unimaginable.”

In vitro fertilization (or IVF) — which involves combining human eggs and sperm outside the body, then implanting the resulting embryo in the womb — dates back to 1981 and has become a welcome form of technology for gay couples and parents facing fertility challenges. Overall, it has helped more than 6 million couples start families nationwide, according to legislators.

More than 4,000 NJ babies a year are born via IVF

In 2017, this process resulted in at least 70,000 births, or about 1.5% of all babies born nationwide. New Jersey has the second highest IVF rate nationwide (after Massachusetts), with nearly 4% — more than 4,000 infants a year — conceived through this process, the federal Centers for Disease Control and Prevention reports.

But while IVF has become more popular and accessible over the years — and the science has improved markedly — experts have long lamented the lack of oversight of the related storage facilities in the United States. In contrast, Canada, the United Kingdom, Sweden, Germany and Australia all heavily regulate many aspects of reproductive technology, according to the Pew Charitable Trusts.

Nationwide, there are more than 440 sites that store embryos or eggs in giant vats of icy-cold liquid nitrogen, but there are no national laws — and few state standards — governing how these samples must be maintained, or for how long. That lack of oversight may have allowed a storage tank at a fertility clinic near Cleveland, Ohio to overheat in 2018, destroying more than 4,000 eggs and embryos; another 1,000 samples were lost in storage tank failures at a San Francisco facility that same weekend.

“Imagine the disappointment of all those in California and Ohio who unnecessarily lost their embryos,” said Assemblyman Raj Mukherji (D-Hudson), another sponsor of the legislation. “Couples grappling with infertility face enough difficulties without hearing the devastating news that facilities storing their embryos lost them in preventable incidents, because they weren’t following a uniform set of regulations.”

Storage protocol is only one concern; proper labeling and handling of eggs and embryos is also essential, experts note. A Los Angeles clinic was sued last summer for confusing samples from different families; in September a New Jersey couple filed suit against an RWJ Barnabas fertility clinic in Livingston, which they claimed had used sperm from someone other than the husband when their daughter was conceived seven years ago.

Failures of storage systems in Ohio and California

The New Jersey proposal — championed by Sens. Loretta Weinberg (D-Bergen) and M. Teresa Ruiz (D-Essex) in the state Senate — was first introduced in October 2018, seven months after the failures at the Ohio and California facilities. The proposed DOH regulations are intended to protect against these kinds of “catastrophic storage system failure[s]” as well as “long-term power outages” due to storms or other natural disasters, the text of the bill (S-3075) notes.

The legislation requires the DOH to consult biomedical tissue-sample experts and relevant federal agencies to develop rules governing operation and maintenance of the storage system used for embryos and human eggs. The state would also need to develop protocols to ensure storage facilities protect the confidentiality of those using their services and maintain quality control of all aspects of their fertility work.

“Infertility is an emotional, challenging issue with so many variables, factors, highs and lows,” said Assemblywoman Valerie Vainieri Huttle (D-Bergen), also a sponsor. “This legislation will help those struggling to conceive have confidence that their embryos are being stored in a facility that is authorized, regulated and properly maintained.”

The measure also calls for each embryo storage site to have a state license posted clearly and pay an annual licensing fee, with the rate to be set by the DOH commissioner; operating a storage program without a license would be a third-degree crime.

Officials from the DOH could inspect the facility and its records at any time, not just during the annual licensing review, and the state could suspend the license at any time if violations were identified. The measure also establishes an appeals process for individuals who lose their license.