Subject of Possible Rule Making: Chapter 246-720 WAC, Donor human milk bank standards. The department of health (department) is considering adopting new standards for ensuring human milk bank safety.

Statutes Authorizing the Agency to Adopt Rules on this Subject: E2SSB 5702 (chapter 236, Laws of 2022).

Reasons Why Rules on this Subject may be Needed and What They Might Accomplish: E2SSB 5702 requires the department to adopt standards to help ensure the safety of human milk donated to milk banks. Beginning January 1, 2023, health carriers shall provide coverage for medically necessary donor human milk for inpatient use when ordered by a licensed health care provider with prescriptive authority or an international board certified lactation consultant. The statute sets specific criteria for coverage.

To ensure the safety of the donated milk, rules may need to be established to address proper screening, milk handling and processing, and recordkeeping. The department will also consider testing standards for the presence of viruses, bacteria, and prescription and nonprescription drugs in the donated milk.

Other Federal and State Agencies that Regulate this Subject and the Process Coordinating the Rule with These Agencies: Donor human milk banks are not regulated by Washington state or federal agencies at this time.

Interested parties can participate in the decision to adopt the new rule and formulation of the proposed rule before publication by contacting Michelle Izumizaki, P.O. Box 47380, Olympia, WA 98504-7903, phone 360-236-3667, fax 360-236-2601, TTY 711, website https://doh.wa.gov/, pchrules@doh.wa.gov; or Ashley Noble, P.O. Box 47380, Olympia, WA 98504-7903, phone 360-628-3776, fax 360-236-2601, website https://doh.wa.gov/, pchrules@doh.wa.gov.

Additional comments: To be added to the department of health's interested parties list, please contact Michelle Izumizaki or Ashely Noble.