INTRODUCTION

The bills would enact requirements and standards for the donation of human milk for infant consumption from hospitals, human milk banks, and human milk banking companies. They also would establish medical assistance coverage under Medicaid for an eligible individual to receive donor human milk for two years after the birth of the individual's child if the individual and child met specified circumstances. The bills' proposed governance and regulation would align with guidelines established by the Milk Banking Association of North America (see BACKGROUND) for the health and safety of infants regarding donated human milk. The bills would prohibit the supply of adulterated or raw human milk and would establish civil and criminal penalties for hospitals, human milk banks, or human milk banking companies that knowingly supplied adulterated or raw human milk for infant consumption. These entities providing milk would have to disclose certain information concerning their procurement and provisioning of the human milk to participating individuals and to the Michigan Department of Health and Human Services (DHHS). To regulate and enforce the bills' provisions, the bills would give the Director of DHHS access to records and samples from the hospital or milk bank. Finally, they would establish a court procedure for human milk that was seized and determined to be adulterated or misbranded, and would establish the parties who would be responsible for the economic loss of human milk in these proceedings.

BRIEF FISCAL IMPACT

The bills would have an indeterminate fiscal impact on local units of government and an indeterminate, potentially significant, negative fiscal impact on the State, mainly stemming from costs to the DHHS and the Michigan Department of Corrections (MDOC). Senate Bill 724 would increase costs for the MDOC by potentially increasing the number of misdemeanor and felony arrests and for the DHHS by increasing administrative costs. The DHHS would face administrative costs related to ability to promulgate rules, costs to secure samples of donor human milk, and costs to properly store donor human milk. Senate Bill 725 would have an indeterminate but potentially significant negative fiscal impact on the Medicaid program within the DHHS. If costs for Medicaid coverage of donor human milk were similar to monthly costs of Women, Infants, and Children (WIC) formula, the State could incur costs approximately equal to $1.1 million General Fund/General Purpose (GF/GP); however, if the cost of Medicaid coverage of donor huma milk were similar to the commercial cost of donor human milk, costs could increase up to $55.5 million GF/GP annually. Senate Bill 726 would have an indeterminate positive impact on the State depending upon judicial decisions related to felony convictions.

Proposed MCL 400.109y (S.B. 725) Legislative Analyst: Jessica Gebbie

MCL 777.12m (S.B. 726) Fiscal Analyst: Ellyn Ackerman

Joe Carrasco, Jr.

Nathan Leaman

John P. Maxwell

CONTENT

Senate Bill 724 would enact a new law to govern the processing and distribution of donated human milk. Specifically, the bill would do the following:

-- Establish that donating human milk would be considered a service and not a for-profit sale.

-- Prohibit hospitals, human milk banks, and human milk banking companies from providing adulterated or raw human milk for infant consumption.

-- Prohibit hospitals, human milk banks, and human milk banking companies from providing adulterated or raw human milk for infant consumption and prescribe civil and criminal penalties for violations of the prohibition.

-- Require a human milk bank and human milk banking company to disclose to participating individuals what it does with its procured milk and allow the DHHS or Department of Licensing and Regulatory Affairs (LARA) to request disclosure of the quantity of human milk accepted or rejected each year.

-- Allow the Director of the DHHS to secure samples of human milk for the purposes of evaluating human milk and determining whether it had been adulterated.

-- Establish enforcement proceedings for the Director of the DHHS to take upon finding or having cause to believe that adulterated or misbranded human milk was distributed or held for distribution, such as the seizure of the human milk.

-- Allow seized human milk to be destroyed at the expense of the claimant of the human milk.

-- Allow the court to direct seized human milk to the claimant for the claimant to label and process the human milk if the court found that the adulteration or misbranding of the human milk could be corrected.

-- Require the State to pay the commercial value of loss to a hospital, human milk bank, or human milk banking company if seized human milk were found to be unadulterated.

-- Allow the DHHS to promulgate rules under the bill.

Senate Bill 725 would amend the Social Welfare Act to allow an eligible individual to receive donated human milk for two years after the birth of the individual's child if a provider prescribed the donor human milk and the individual could not provide milk or the infant was born before thirty-four weeks or weighed less than 1,800 grams at birth.

Senate Bill 726 would add sentencing guidelines to the Criminal Procedure Code for violations of Senate Bill 724's proposed prohibitions.

Senate Bill 724 and Senate Bill 726 are tie-barred. Senate Bill 725 would take effect January 1, 2026. Senate Bill 724 is described in greater detail below.

Senate Bill 724

Definitions

"Adulterated" would mean human breast milk that is any of the following:

-- Has been improperly processed, including improper or unknown storage temperatures after receipt by a human milk bank or human milk banking company or improper pasteurization times or temperatures based on standards set by the Human Milk Banking Association of North America (see BACKGROUND).

-- Is contaminated with a poisonous or deleterious substance that may render the human milk injurious to the health of an infant.

-- Any other condition that created a risk to public health, safety, or welfare.

"Distribution" would mean the removal of human milk from a human milk bank or human milk banking company to any other location for processing or storage, or for the purpose of providing human milk to a hospital or selling human milk to another entity.

"Donor" would mean a lactating individual who voluntarily contributes the individual's own expressed breast milk to a human milk bank or human milk banking company for use by an infant or child other than the individual's own infant or child. A donor could be provided with supplies reasonably necessary for safe milk expression, storage, or transport.

"Economic benefit" would include any collection or processing fee related to the violation.

"Hospital" would mean that term as defined by the Public Health Code's Part 58A (Infant Death Due to Unsafe Sleep Education and Prevention): a licensed hospital that provides clinically related health services for obstetrical and infant care and includes a hospital operated by the State, a local governmental unit, or an agency. The term does not include an office used primarily for private or group practice by health professionals in which no reviewable, clinically related health services are offered.

"Human milk bank" would mean a member in good standing of the Human Milk Banking Association of North America, a hospital-based or affiliated organization, or other not-for-profit organization that is focused on procuring, processing, storing, and distributing human milk for use by individuals most in need, including the following:

-- Medically fragile, low birth weight, or preterm infants.

-- Individuals with delayed lactation.

-- Infants recovering from serious abdominal or gastrointestinal complications or surgery.

"Human milk banking company" would mean a company, organization, or cooperative that may engage in the practice of providing remuneration to lactating individuals for their expressed human milk or otherwise collects human milk. Remuneration within the definition would not include receipt of a breast pump or other supplies reasonably necessary for safe milk expression, storage, or transport.

"Processing" would mean the use of rigorous protocols and requirements based on scientific evidence and recommendations from the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the Human Milk Banking Association of North America that are required to prepare, identify, and label human milk, including the FDA's rules on Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.

"Procuring" would mean obtaining human milk.

"Storage" or "storing" would mean holding human milk in connection with procuring or processing it before distribution and during the time held before distribution.

Governance and Regulation of Donated Human Milk

The bill would enact a new law to govern the procurement and distribution of human milk for the purpose of infant consumption. Under the bill, the procuring, processing, storing, distributing, or using human milk for the purpose of infant consumption from a human milk bank would be considered rendering a service, and not the sale of human milk for profit or financial gain.

A hospital, human milk bank, or human milk banking company that procured human milk from an individual to nourish a child other than the individual's own child would be prohibited from providing adulterated human milk for infant consumption, and would have to comply with standards of the FDA, CDC, and Human Milk Banking Association (see BACKGROUND).

The bill would not apply to individual-to-individual human milk sharing groups or individuals feeding their own children.

The DHHS could promulgate rules to implement the bill in accordance with the Administrative Procedures Act.

Penalties for Adulterated Human Milk

The bill would prohibit hospitals, milk banks, and milk banking companies from knowingly providing adulterated human milk. If the adulterated human milk did not result in physical injury or death, a hospital, milk bank, or milk banking company would be guilty of a State civil infraction and could be ordered to pay a civil fine of up to $5,000. If the adulterated human milk resulted in physical injury, a hospital, milk bank, or milk banking company would be guilty of a felony punishable by imprisonment for up to five years or a fine of up to $10,000 plus twice the amount of any economic benefit associated with the violation, or both. If the adulterated human milk resulted in death, a hospital, milk bank, or milk banking company would be guilty of a felony punishable by imprisonment for up to 15 years or a fine of up to $15,000 plus twice the amount of any economic benefit associated with the violation, or both.

The bill would not prohibit a hospital, milk bank, or milk banking company from being charged with, convicted of, or punished for any other violations of law committed while knowingly violating or knowingly attempting to violate the bill's prohibitions above, including the underlying offense.

The bill would require that a human milk donor be screened for drugs, substances, and pathological diseases tested serologically, as determined by the Human Milk Banking Association. Screening would not be required for human milk collected from an individual exclusively for an individual's own child.

Raw Human Milk

The bill would prohibit a human milk bank or human milk banking company from providing raw human milk for the purpose of human consumption. (The Human Milk Banking Association requires donated milk to be pasteurized.) If the raw human milk did not result in physical injury or death, a milk bank or milk banking company would be guilty of a State civil infraction and could be ordered to pay a civil fine of up to $5,000. If the raw human milk resulted in physical injury, a milk bank or milk banking company would be guilty of a felony punishable by imprisonment for up to five years or a fine of up to $10,000 plus twice the amount of any economic benefit associated with the violation, or both. If the raw human milk resulted in death, a milk bank or milk banking company would be guilty of a felony punishable by imprisonment for up to 15 years or a fine of up to $15,000 plus twice the amount of any economic benefit associated with the violation, or both.

The bill would not prohibit a human milk bank or human milk banking company from being charged with, convicted of, or punished for any other violations of law committed by that hospital or milk bank while knowingly violating or knowingly attempting to violate the charges described, including the underlying offense.

Human Milk Bank Disclosure

Under the bill, a human milk bank or human milk banking company operating in the State would have to disclose to participating individuals what the bank does with all the procured human milk, regardless of whether the human milk was accepted or rejected by the human milk bank or human milk banking company. The disclosure would have to be on a form and in a manner prescribed by the DHHS in consultation with human milk banks and human milk banking companies. The DHHS or LARA could request that a human milk bank or human milk banking company disclose the quantity of human milk that was accepted or rejected each year.

Evaluation of a Hospital or Human Milk Bank

The bill would grant the DHHS Director free access at reasonable hours to any hospital, human milk bank, or human milk banking company to evaluate the hospital, human milk bank, or human milk banking company to determine if the bill or rules promulgated under the bill were being violated. The Director could secure samples of any human milk, after paying or offering to pay for the samples, to determine if there were a violation.

In accordance with the Health Insurance Portability and Accountability Act, the Director could examine the records of the hospital, human milk bank, or human milk banking company, to obtain pertinent information about the human milk, supplies, and equipment purchased, received, or used by, or individuals employed by, the hospital, human milk bank, or human milk banking company, or location. The Director could take photographs or copy records as part of an evaluation.

If a hospital, human milk bank, or human milk banking company identified by written document or mark that a certain area or record contained visible trade secrets, the Director would have to identify any photographs of that area or copies of that record as being confidential and diligently protect the confidentiality. Such information and records would not be subject to disclosure under the Freedom of Information Act.

Enforcement

Under the bill, if the Director found it necessary for the enforcement of the bill's provisions, the Director could seize any human milk found to be distributed, held for distribution, or exposed for sale in violation of the bill, without a formal warrant. If the Director found or had probable cause to believe that human milk was adulterated or so misbranded as to be dangerous to public health or fraudulent, the Director could seize the human milk and affix to the human milk a tag or other appropriate marking giving notice that the human milk was, or was suspected of being, adulterated or misbranded and had been seized. The human milk tagged or marked as adulterated or misbranded and seized could not be disposed of, by sale or otherwise, until permission for removal of the tag or disposal of the human milk was authorized by the Director or a court.

If seized human milk were determined by the Director to be adulterated or misbranded, the Director would have to file a petition in the circuit court in the jurisdiction in which the human milk was seized for a complaint for condemnation of the human milk. Seized human milk would have to be stored by the DHHS safely and at appropriate temperatures during the period of investigation. Seized human milk could be destroyed at the expense of the claimant of the human milk, under the supervision of the Director, and the court could order the payment of the costs, fees, storage, and other proper expenses by the claimant of the human milk or the claimant's agents.

If the court found that adulteration or misbranding could be corrected by proper labeling or processing of the human milk, after entry of the order; payment of the costs, fees, and expenses; and execution of a good and sufficient bond conditioned that the human milk be labeled or processed properly, the court could direct the human milk to be delivered to the claimant for labeling or processing under the Director's supervision. The claimant would have to pay the expense of the supervision. The human milk would have to be returned to the claimant of the human milk on the representation to the court by the Director that the human milk was no longer in violation of the bill and that the expenses of supervision had been paid.

If the Director determined that the seized human milk was not adulterated or misbranded, the Director would have to remove the tag or other marking. If, within the course of the investigation, previously unadulterated human milk became adulterated, the State would have to pay the commercial value of the loss to the hospital, human milk bank, or human milk banking company from which the human milk was seized.

PREVIOUS LEGISLATION

(This section does not provide a comprehensive account of previous legislative efforts on this subject matter.)

Senate Bill 724 is a reintroduction of Senate Bill 1054 from the 2023-2024 Session.

BACKGROUND

According to the FDA, the Human Milk Banking Association of North America is a nonprofit accrediting organization that sets safety standards for its member milk banks in the U.S. and Canada.¹ According to its website, the Association services member milk banks, the banks provide donor milk to the community, and infants receive donor milk from hospitals or at home. The Association sets guidelines for pasteurized donor human milk and accredits milk banks that receive donated human milk from individuals. The milk banks screen, pasteurize, and test the donation and then distribute the human milk. The hospitals and outpatient recipients pay a processing fee to the milk bank. According to the Association, pasteurizing human milk is required to eliminate harmful bacteria or potential infecting organisms.²

FISCAL IMPACT

The bills would have an indeterminate negative impact on the DHHS. The DHHS would incur minor administrative costs from the requirement that it develop the form and manner in which a human milk bank or milk banking company would have to disclose information concerning any procured human milk. Additionally, the bill would allow the DHHS to promulgate rules to implement the bill, meaning the DHHS would only incur administrative costs if it decided to.

Under the bills, the DHHS could secure samples to determine if the human milk bank or milk banking company was in violation of the bills. The DHHS would have to pay or offer to pay for the samples, although the bill does not specify what the reimbursement would be based on. The DHHS would face minor costs depending on if, and how much, it paid to secure samples.

Finally, the DHHS would have to properly store any human milk it seized that it had probable cause to believe was adulterated or misbranded as to be dangerous. A court could order the claimant to pay the cost of destruction and storage, but if the court did not order payment the DHHS would bear the cost of storage until allowed to destroy the milk. Costs could become

This analysis was prepared by nonpartisan Senate staff for use by the Senate in its deliberations and does not constitute an official statement of legislative intent.