Measure Requires License to Operate, Establishes Third-Degree Offense for Violators
In an effort to prevent a repeat of tragedies in other states where thousands of embryos were lost, a measure sponsored by Assembly Democrats Pamela Lampitt, Raj Mukherji and Valerie Vainieri Huttle was approved 71-3 in the full Assembly on Monday in concurrence with the Governor’s recommendations.
Prompted by disasters in California and Ohio where more than four thousand eggs and embryos were lost, the bill (A-4605) would require the New Jersey Department of Health (DOH) to regulate and license embryo storage facilities. In certain cases, the loss of eggs and embryos was caused by improper monitoring of storage temperature fluctuations—an operational issue that could have been avoided. The legislation looks to guard against such operational mishaps as well as long-term power outages during natural disasters or catastrophic storage system failures.
“Families attempting to conceive face a number of physical and emotional challenges,” said Lampitt (D-Burlington, Camden). “They put their hopes and dreams of conceiving into the embryos stored in these facilities. To have those dreams shattered due to a preventable operating failure is unimaginable.”
An embryo storage facility cryopreserves and stores human eggs, pre-embryos, and embryos for later use during in vitro fertilization, embryo transfer, gamete transfer, pronuclear stage transfer and zygote transfer, as well as other procedures performed to achieve a pregnancy or pregnancies. Under the bill, facilities as well as licensed health care providers that store human eggs, pre-embryos, or embryos will only be allowed to operate if granted a license by the DOH. It would also become a third degree crime to operate an embryo storage facility without licensure or to misrepresent such licensure to consumers.
“Imagine the disappointment of all those in California and Ohio who unnecessarily lost their embryos,” said Assemblyman Mukherji (D-Hudson). “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. By requiring licensure of these facilities, enacting rules, and commencing onsite inspections, we can ensure that New Jersey couples planning IVF don’t suffer from the tragedies we’ve seen elsewhere and go on to realize the miracle of conceiving a child.”
Under the bill, the DOH would be required to establish guidelines for the storage and care of human eggs, pre-embryos, and embryos by a facility. Guidelines for operation would also be established in accordance to nationally and internationally recognized standards, and would require facilities to comply with state and local safety protocols. The legislation further provides for unannounced on-site facility inspections to monitor and examine the physical facilities, as well as the maintenance of certain documents and data.
“Infertility is an emotional, challenging issue with so many variables, factors, highs and lows,” said Assemblywoman Vainieri Huttle (D-Bergen). “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 Governor’s recommendation extends the bill’s effective date by seven months providing additional time for implementation by the DOH as this regulatory program will be the first of its kind in the nation.
The bill passed 30-0 in the Senate in August 2019 and now goes to the Governor’s desk.