TITLE 25. HEALTH SERVICES

PART 1. DEPARTMENT OF STATE HEALTH SERVICES

CHAPTER 227. MINIMUM GUIDELINES FOR HUMAN DONOR MILK BANKS

The executive commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Texas Department of State Health Services (DSHS), adopts an amendment to §227.1, concerning Minimum Guidelines for Human Donor Milk Banks.

Section 227.1 is adopted without changes to the proposed text as published in the June 5, 2026, issue of the Texas Register (51 TexReg 3774). This rule will not be republished.

BACKGROUND AND JUSTIFICATION

The amendment is necessary to comply with Texas Health and Safety Code (HSC) §161.071, which requires DSHS to establish minimum guidelines for the procurement, processing, distribution, or use of human milk by donor milk banks. DSHS uses Human Milk Banking Association of North America (HMBANA) standards to determine minimum Texas human donor milk bank guidelines. The amendment updates the reference to current HMBANA guidelines.

COMMENTS

The 31-day comment period ended July 6, 2026.

DSHS received comments regarding the proposed rule from four commenters. DSHS received comments from individuals representing themselves affiliated with UT Southwestern Medical School, UT Southwestern Medical Center, and UT Austin College of Natural Sciences. A summary of comments relating to the rule and DSHS' responses follows.

Comment: All four commenters agreed on alignment with updated HMBANA guidelines.

Response: DSHS agrees and made no revision to the rule text in response to these comments.

Comment: A commenter suggested DSHS add educational resources to its website on human donor milk banking.

Response: DSHS agrees and will add educational resources to its website on human donor milk banking. DSHS made no revision to the rule text in response to this comment as these resources will be made available on the website and not in the rule text.

Comment: A commenter suggested DSHS consider voluntary reporting by milk banks on adherence to current HMBANA standards.

Response: DSHS disagrees. HMBANA monitors adherence to required reporting. DSHS made no revision to the rule text in response to these comments.

Comment: A commenter suggested DSHS consider that additional milk bank costs and responsibilities may increase the cost of donor milk.

Response: DSHS disagrees as the rule amendment does not require additional cost for milk banks. DSHS made no revision to the rule text in response to these comments.

Comment: A commenter encourages state policy makers to consider complementary measures such as simplifying prior authorization processes and expanding Medicaid coverage for human donor milk, to ensure availability for all eligible infants.

Response: DSHS disagrees as changes to Medicaid policy fall outside the scope of this rule amendment. DSHS made no revision to the rule text in response to these comments.

Comment: A commenter suggested DSHS require Texas milk banks to make operative portions of the HMBANA standards available for public inspection upon request.

Response: DSHS disagrees. HMBANA provides a standards overview document on their website, but the full list of standards is proprietary and only provided to each HMBANA-accredited member milk bank, along with accreditation documents and other tools. DSHS made no revision to the rule text in response to these comments.

STATUTORY AUTHORITY

The amendment is adopted under Texas Government Code §524.0151, which provides that the executive commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services system, and Texas Health and Safety Code §1001.075, which authorizes the executive commissioner of HHSC to adopt rules and policies for the operation and provision of health and human services by DSHS and for the administration of Texas Health and Safety Code Chapter 1001.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on August 27, 2026.

TRD-202603749

Cynthia Hernandez

General Counsel

Department of State Health Services

Effective date: September 16, 2026

Proposal publication date: June 5, 2026

For further information, please call: (512) 239-8263