Bill Text: MI SB1054 | 2023-2024 | 102nd Legislature | Introduced
Bill Title: Food: milk; human breast milk banks, companies, and cooperatives; regulate. Creates new act. TIE BAR WITH: SB 1055'24
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Introduced) 2024-10-30 - Referred To Committee On Housing And Human Services [SB1054 Detail]
Download: Michigan-2023-SB1054-Introduced.html
SENATE BILL NO. 1054
the people of the state of michigan enact:
(a) "Adulterated" means human breast milk that is any of the following:
(i) Has been improperly processed, including, but not limited to, 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.
(ii) Is contaminated with a poisonous or deleterious substance that may render the human milk injurious to the health of an infant.
(iii) Any other condition that creates a risk to public health, safety, or welfare.
(b) "Department" means the department of health and human services.
(c) "Director" means the director of the department or the director's designee.
(d) "Distribution" means 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.
(e) "Donor" means 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 may be provided supplies reasonably necessary for safe milk expression, storage, or transport under this act.
(f) "Hospital" means that term as defined in section 5883 of the public health code, 1978 PA 368, MCL 333.5883.
(g) "Human milk bank" means 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, but not limited to, the following:
(i) Medically fragile, low birth weight, or preterm infants.
(ii) Individuals with delayed lactation.
(iii) Infants recovering from serious abdominal or gastrointestinal complications or surgery.
(h) "Human milk banking company" means 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 does not include receipt of a breast pump or other supplies reasonably necessary for safe milk expression, storage, or transport.
(i) "Processing" means the use of rigorous protocols and requirements based on scientific evidence and recommendations from the Food and Drug Administration, the Centers for Disease Control and Prevention, and the Human Milk Banking Association of North America that are required to prepare, identify, and label human milk, including, but not limited to, 21 CFR part 110 and 21 CFR part 117.
(j) "Procuring" means obtaining human milk.
(k) "Storage" or "storing" means holding human milk in connection with procuring or processing it before distribution and during the time held before distribution.
Sec. 3. (1) Procuring, processing, storing, distributing, or using human milk for the purpose of infant consumption from a human milk bank is a rendering of a service and not the sale of human milk for profit or financial gain.
(2) An individual, hospital, human milk bank, or human milk banking company that procures, processes, stores, or distributes human milk from an individual to nourish a child other than the individual's own child shall not provide adulterated human milk for the purpose of infant consumption and shall comply with the standards set forth by the department under this act and standards set forth by the Food and Drug Administration, the Centers for Disease Control and Prevention, and the Human Milk Banking Association of North America. An individual, hospital, human milk bank, or human milk banking company that knowingly provides adulterated human milk is guilty of 1 or more of the following:
(a) If the violation does not result in physical injury or death, a state civil infraction and may be ordered to pay a civil fine of not more than $5,000.00.
(b) If the violation results in physical injury, a felony punishable by imprisonment for not more than 5 years, or a fine of not more than $10,000.00 plus twice the amount of any economic benefit associated with the violation, or both. As used in this subdivision and subdivision (c), "economic benefit" includes any collection or processing fee related to the violation.
(c) If the violation results in death, a felony punishable by imprisonment for not more than 15 years, or a fine of not more than $15,000.00 plus twice the amount of any economic benefit associated with the violation, or both.
(3) Subsection (2) does not prohibit an individual, hospital, human milk bank, or human milk banking company from being charged with, convicted of, or punished for any other violation of law committed by that individual, hospital, human milk bank, or human milk banking company while knowingly violating or knowingly attempting to violate subsection (2), including the underlying offense.
(4) If a donor provides human milk to a hospital, human milk bank, or human milk banking company, that donor must be screened for drugs, substances, and pathological diseases tested serologically, as determined by the Human Milk Banking Association of North America. Screening is not required on human milk collected from an individual exclusively for the individual's own child.
Sec. 5. (1) An individual, human milk bank, or human milk banking company that provides human milk for the purpose of human consumption shall not provide raw human milk for the purpose of infant consumption and must comply with the rules promulgated under this act. An individual, human milk bank, or human milk banking company that knowingly violates this subsection is guilty of 1 or more of the following:
(a) If the violation does not result in physical injury or death, a state civil infraction and may be ordered to pay a civil fine of not more than $5,000.00.
(b) If the violation results in physical injury, a felony punishable by imprisonment for not more than 5 years, or a fine of not more than $10,000.00 plus twice the amount of any economic benefit associated with the violation, or both. As used in this subdivision and subdivision (c), "economic benefit" includes any collection or processing fee related to the violation.
(c) If the violation results in death, a felony punishable by imprisonment for not more than 15 years, or a fine of not more than $15,000.00 plus twice the amount of any economic benefit associated with the violation, or both.
(2) Subsection (1) does not prohibit an individual, human milk bank, or human milk banking company from being charged with, convicted of, or punished for any other violation of law committed by that individual, human milk bank, or human milk banking company while knowingly violating or knowingly attempting to violate subsection (1), including the underlying offense.
Sec. 7. (1) A person shall not, for valuable consideration, knowingly sell human breast milk over the internet. This subsection applies only to person-to-person direct sales and person-to-person sales through classified advertisements.
(2) The prohibition under subsection (1) does not apply to informal milk sharing between families done without taking monetary payment or a community-based milk sharing program. As used in this subsection, "community-based milk sharing program" means any formal or informal organization with the intent to provide human milk to those in need without compensation.
(3) A person that violates subsection (1) is subject to a civil fine of not less than $1,000.00 or more than $10,000.00. The prosecutor of the county in which the violation occurred or the attorney general may bring an action to collect the fine.
Sec. 9. A human milk bank or human milk banking company shall provide or refer the donor to receive lactation support and education that prioritizes the needs of the donor's infant. The education may include information on the nutritional needs of the donor's infant, and breast milk supply and demand, and may be provided by a lactation professional working with a community-based group or hospital-based lactation service.
Sec. 11. A human milk bank or human milk banking company operating in this state shall disclose to participating individuals what it does with all of the procured human milk, regardless of whether the human milk is accepted or rejected by the human milk bank or human milk banking company. The disclosure under this section must be in a form and manner prescribed by the department in consultation with human milk banks and human milk banking companies. The department or the department of licensing and regulatory affairs may request that a human milk bank or human milk banking company disclose the quantity of human milk that was accepted or rejected each year.
Sec. 13. (1) The director has free access at reasonable hours to any hospital, human milk bank, or human milk banking company for the purpose of evaluating the hospital, human milk bank, or human milk banking company to determine if this act or rules promulgated under this act are being violated. The director may secure samples of any human milk, after paying or offering to pay for the samples, to determine if this act or rules promulgated under this act are being violated.
(2) In accordance with the health insurance portability and accountability act of 1996, Public Law 104-191, the director may 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.
(3) The director may take photographs or copy records as part of an evaluation. If a hospital, human milk bank, or human milk banking company identifies by written document or mark that a certain area or record contains visible trade secrets, the director shall identify any photographs of that area or copies of that record as being confidential and diligently protect the confidentiality. Information and records obtained under this subsection are not subject to disclosure under the freedom of information act, 1976 PA 442, MCL 15.231 to 15.246.
Sec. 15. (1) If necessary for the enforcement of this act, the director may seize without formal warrant any human milk found to be distributed, held for distribution, or exposed for sale in violation of this act or rules promulgated under this act.
(2) If the director finds or has probable cause to believe that human milk is adulterated or so misbranded as to be dangerous to public health or fraudulent, within the meaning of this act, the director shall seize the human milk and affix to the human milk a tag or other appropriate marking giving notice that the human milk is, or is suspected of being, adulterated or misbranded and has been seized. The human milk tagged or marked as adulterated or misbranded and seized under subsection (1) or this subsection must not be disposed of, by sale or otherwise, until permission for removal of the tag or disposal of the human milk is authorized by the director or a court in accordance with subsection (3).
(3) If human milk seized under subsection (1) or (2) is determined by the director to be adulterated or misbranded, the director shall file a petition in the circuit court in whose jurisdiction the human milk is seized for a complaint for condemnation of the human milk. Seized human milk must be stored by the department safely and at appropriate temperatures during the period of investigation. Seized human milk may be destroyed at the expense of the claimant of the human milk, under the supervision of the director, and the court may 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 finds that adulteration or misbranding can 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 may direct the human milk to be delivered to the claimant for labeling or processing under the director's supervision. The claimant shall pay the expense of the supervision. The human milk must be returned to the claimant of the human milk on the representation to the court by the director that the human milk is no longer in violation of this act and that the expenses of supervision have been paid. If the director determines that the human milk seized is not adulterated or misbranded, the director shall remove the tag or other marking. If, within the course of the investigation, previously unadulterated human milk becomes adulterated, the state shall pay the commercial value of the loss to the individual, hospital, human milk bank, or human milk banking company from which the human milk was seized.
Sec. 17. This act does not apply to individual-to-individual human milk sharing groups or individuals feeding their own children.
Sec. 19. The department may promulgate rules to implement this act in accordance with the administrative procedures act of 1969, 1969 PA 306, MCL 24.201 to 24.328.
Enacting section 1. This act takes effect January 1, 2026.
Enacting section 2. This act does not take effect unless Senate Bill No. 1055 of the 102nd Legislature is enacted into law.
