SB 724

SENATE BILL NO. 724
A bill to require hospitals, human milk
banks, and human milk banking companies to comply with certain standards; to
provide for education and support of certain breastfeeding individuals; to
prescribe the duties of certain state departments and agencies; and to
prescribe penalties.
the people of the state of michigan enact:
Sec. 1. As used in this
act:
(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) A 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 United States Food and Drug Administration, the Centers for
Disease Control and Prevention, and the Human Milk Banking Association of North
America. A 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 a
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 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) A 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. A 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 a
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 human milk bank or
human milk banking company while knowingly violating or knowingly attempting to
violate subsection (1), including the underlying offense.
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 on a form
and in a 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 the jurisdiction
in which 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 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 does not take effect unless Senate Bill No. 726 of the 103rd Legislature is
enacted into law.