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  • NJ A1442
  • Provides for registration and accreditation of human milk banks.*
In Committee
Crossed OverPassedSignedDead/Failed/Vetoed
2016-2017 Regular Session
This bill would provide for the licensure of human milk banks. As defined in the bill, "human milk bank" means an organized service for the selection of a donor of human breast milk, the collection, processing, storage, and marketing of donated human breast milk, and the distribution of donated human breast milk to a hospital for use by low birth weight babies or new mothers with delayed lactation, or directly to a parent, with a physician's prescription order, who is unable to nurse, or is in need of additional breast milk to feed, the parent's child. Specifically, the bill requires that a person (a person, partnership, association, agency, organization, or other similar type entity) be licensed by the Department of Health (DOH) in order to operate a human milk bank in the State. A copy of the license would be displayed on the premises of the milk bank. Under the provisions of the bill, a person desiring to operate a human milk bank would apply for a license on a form and in a manner prescribed by the Commissioner of Health. If a human milk bank meets the requirements of this act, DOH would issue a license to the milk bank and the license would be valid for one year. An application to renew a license would be made 60 days prior to the anniversary date of licensure and each application for and renewal of a license to operate a human milk bank would be accompanied by a fee established by the commissioner. The commissioner would be allowed to periodically increase the application and renewal fees to reflect increased State costs in licensing milk banks. The bill also gives DOH the authority to license and inspect human milk banks, including an inspection of records, files, and other data, and requires the commissioner to promulgate rules and regulations for the operation and maintenance of human milk banks. The rules and regulations governing human milk banks would include provisions for: staff qualifications; procedures for selecting and screening potential donors; standards for the collection, processing, storage, marketing, and distribution of donated breast milk; the maintenance and confidentiality of milk bank records; and license application, issuance, renewal, expiration, denial, suspension, and revocation. The bill would require the rules and regulations, at a minimum, to require human milk banks to be operated in accordance with protocols that have been established by the Human Milk Banking Association of North America. In addition, in promulgating rules and regulations, the commissioner would also be required to consider applicable regulations or recommendations that have been adopted by other federal or national agencies or organizations. DOH would be allowed to deny, suspend, revoke, or refuse to renew a license to a human milk bank for good cause, and would be required to give notice to an applicant or a licensee before denying, suspending, revoking, or refusing to renew a license. The applicant or licensee would be noticed personally or by certified or registered mail to the applicant's or licensee's last known address with return receipt requested in order to afford the applicant or licensee an opportunity to be heard. The hearing would take place within 60 days from the issuance or mailing of the notice. The bill gives the commissioner the authority to institute a civil action to enjoin the operation of a human milk bank whenever the commissioner determines that: a condition exists or has occurred at the human milk bank that is dangerous to the public health; a milk bank has repeatedly violated the provisions of the bill; or a milk bank has opened or is operating without a license or without complying with the provisions of the bill. The commissioner could also request other relief, and in any action, the court would proceed in a summary manner. Any person aggrieved by a final decision of the commissioner would be entitled to seek judicial review. Finally, the bill stipulates that any person who: operates a human milk bank that does not have a license; has used fraud or misrepresentation in obtaining a license or in the subsequent operation of a human milk bank; offers, advertises, or provides any service not authorized by a valid license; or violates any other provision of the bill would be subject to a penalty of not less than $100 or more than $1,000 for the first offense and not less than $500 or more than $5,000 for the second or any subsequent offense. DOH would enforce and collect any penalty imposed in accordance with the "Penalty Enforcement Law of 1999," P.L.1999, c.274 (C.2A:58-10 et seq.). The penalty would be recovered by the commissioner and paid into the State treasury.
2nd Reading in the Assembly, Regulated Professions, Substituted by another Bill
Substituted by S974 (1R)  (on 12/7/2017)
Date Chamber Action Description
12/7/2017 A Substituted by S974 (1R)
11/30/2017 A Reported from Assembly Comm. as a Substitute, 2nd Reading
11/30/2017 Assembly Regulated Professions Hearing (19:00 11/30/2017 )
1/27/2016 A Introduced, Referred to Assembly Regulated Professions Committee
Date Motion Yea Nay Other
Detail 11/30/2017 Assembly Regulated Professions Committee: Reported with Substitution 7 0 2