A1442

An Act concerning human milk banks and supplementing Title 26 of the Revised Statutes.

Be It Enacted by the Senate and General Assembly of the State of New Jersey:

1. For the purposes of this act:

"Collection" means the obtaining of donated human breast milk.

"Commissioner" means the Commissioner of Health.

"Department" means the Department of Health.

"Distribution" means the removal of donated human breast milk from a human milk bank to any other location for processing or storage or for the purpose of providing breast milk to a hospital or selling breast milk to a parent.

"Human milk bank" means an organized service that provides for the selection of a donor of human breast milk, the collection, processing, storage, and marketing of donated human breast milk,and the distributionof 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.

"Licensee" means a person holding a license under the provisions of this act.

“Marketing” means the use of suitable media to advertise the availability of, promote the appropriate use of, and provide information on how to safely procure, donated human breast milk.

"Person" means a person, partnership, association, agency, organization, or other similar entity.

"Processing" means the technical stages required to prepare and identify donated human breast milk as to its suitability.

"Storage" means the holding of donated human breast milk in connection with collection or processing prior to its distribution.

2. a. A person shall not operate a human milk bank in this State unless licensed by the department pursuant to this act. A copy of the license shall be conspicuously displayed by the licensee at the premises occupied as a milk bank.

b. Any person desiring to operate a human milk bank shall apply to the department for a license on a form and in a manner prescribed by the commissioner. If a human milk bank meets the requirements of this act, the department shall issue a license to the milk bank. The license to operate a human milk bank shall be valid for one year from the date of issuance.

c. An application for renewal of the license shall be made no later than the 60th day preceding the anniversary date of licensure on a form and in a manner prescribed by the commissioner.

d. Each application for and renewal of a license to operate a human milk bank shall be accompanied by a fee established by the commissioner. The commissioner may periodically increase the application and renewal of application fee to reflect increased State costs in the licensure of human milk banks.

3. a. The department shall have responsibility and authority to license and inspect human milk banks. The commissioner shall promulgate rules and regulations for the operation and maintenance of human milk banks. The regulations shall include, but not be limited to, provisions for:

(1) the qualifications of personnel employed in a human milk bank;

(2) procedures for the screening and selection of prospective donors;

(3) standards for the collection, processing, storage, marketing, and distribution of donated human breast milk; and

(4) the maintenance and confidentiality of records and furnishing of required information.

b. The commissioner shall also promulgate rules and regulations for license application, issuance, renewal, expiration, denial, suspension, and revocation.

c. At a minimum, the rules and regulations adopted pursuant to this section shall 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 pursuant to this section, the commissioner shall give consideration to applicable regulations or recommendations that have been adopted by otherfederal or national agencies or organizations.

d. The department shall conduct an on-site facility inspection of human milk banks and shall inspect documents, records, files, or other data maintained by a human milk bank during normal operating hours and without prior notice.

4. The department may deny, suspend, revoke, or refuse to renew a license to operate a human milk bank for good cause, including, but not limited to:

a. failure of a human milk bank to comply with the provisions of this act , or the rules and regulations adopted pursuant thereto;

b. violation of the terms and conditions of a license by a human milk bank;

c. use of fraud or misrepresentation by a milk bank in obtaining a license or in the subsequent operation of the human milk bank;

d. refusal by a milk bank to furnish the department with required files, reports, or records; and

e. refusal by a human milk bank to permit an inspection by an authorized representative of the department during normal operating hours.

5. The department, before denying, suspending, revoking, or refusing to renew a license to operate a human milk bank, shall give notice to the applicant or licensee personally, or by certified or registered mail to the last known address of the applicant or licensee with return receipt requested. The notice shall afford the applicant or licensee with an opportunity to be heard. The hearing shall take place within 60 days from the issuance or mailing of the notice and shall be conducted in accordance with the "Administrative Procedure Act," P.L.1968, c.410 (C.52:14B-1 et seq.).

6. a. The commissioner is authorized to institute a civil action in a court of competent jurisdiction for injunctive relief to enjoin the operation of a human milk bank whenever the commissioner determines that:

(1) a condition exists or has occurred at the human milk bank that is dangerous to the public health;

(2) the human milk bank has repeatedly violated the provisions of this act; or

(3) a human milk bank has opened or is operating without a license or without complying with the provisions of this act.

b. The commissioner may, in addition, request such other relief as is deemed necessary. In any such action the court may proceed in a summary manner.

c. Any person aggrieved by a final decision of the commissioner shall be entitled to seek judicial review in the Appellate Division of the Superior Court. All petitions for review shall be filed in accordance with the Rules of the Court.

7. a. Any person who operates a human milk bank that does not have a license, or who has used fraud or misrepresentation in obtaining a license or in the subsequent operation of a human milk bank, or who offers, advertises, or provides any service not authorized by a valid license, or who violates any other provision of this act shall 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.

b. The department shall have the jurisdiction to enforce and collect any penalty imposed because of a violation of this act in a summary proceeding in accordance with the "Penalty Enforcement Law of 1999," P.L.1999, c.274 (C.2A:58-10 et seq.). Process shall be in the nature of a summons or warrant and shall issue only at the suit of the commissioner as plaintiff.

c. A penalty recovered pursuant to the provisions of this section shall be recovered by the commissioner and paid into the State treasury.

8. The commissioner, pursuant to the "Administrative Procedure Act," P.L.1968, c.410 (C.52:14B-1 et seq.), shall adopt rules and regulations necessary to effectuate the purposes of this act.

9. This act shall take effect on the 180th day after the date of enactment but the commissioner may take such anticipatory administrative action in advance thereof as shall be necessary for the implementation of this act.

STATEMENT

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.