NJ Health Department Proposes New Licensing Rules for Embryo Storage Facilities

Proposed regulations would establish operational standards, enforcement mechanisms, and oversight procedures for facilities storing human embryos.

TRENTON, NJ — The New Jersey Department of Health (NJDOH) has announced a proposal to implement new licensing and regulatory standards for embryo storage facilities (ESFs) under a newly introduced rule at N.J.A.C. 8:77, as required by N.J.S.A. 26:2A-23 et seq.

The proposed rule, published in the September 15, 2025, issue of the New Jersey Register, would establish a statewide regulatory framework for the oversight of ESFs, which are entities that store human embryos for use in fertility treatments and other reproductive procedures.

Scope of the Proposed Rule

If adopted, N.J.A.C. 8:77 would set mandatory requirements for ESFs, including:

• Development of administrative and operational policies and procedures

• Maintenance of comprehensive records and reporting of certain events

• Compliance with standards related to:

  • Personnel qualifications

  • Facility infrastructure (physical plant)

  • Safety and sanitation

  • Emergency preparedness

  • Quality management systems

The rule would also empower the Department to enforce compliance, including:

• Monetary penalties for violations

• Suspension, revocation, or denial of license renewals

• Clearly defined appeal procedures

Legal Background

The proposed rule is designed to implement provisions of N.J.S.A. 26:2A-23 et seq., a state law that mandates the regulation of facilities involved in the long-term storage of embryos. The new framework addresses a regulatory gap by setting standards for a sensitive and complex area of reproductive health.

Public Comment Period

Members of the public and stakeholders are encouraged to submit comments on the proposed rule by November 14, 2025. Comments can be sent:

• Electronically at: nj.gov/health/legal/ecomments.shtml

• By mail to:
  Kimberly E. Jenkins
  Director, Office of Legal and Regulatory Compliance
  New Jersey Department of Health
  PO Box 360, Trenton, NJ 08625-0360

The proposal marks a significant step in formalizing oversight of embryo storage practices in New Jersey, with the goal of ensuring facility safety, regulatory accountability, and patient protection in the field of reproductive medicine.