The Florida Senate
BILL ANALYSIS AND FISCAL IMPACT STATEMENT
(This document is based on the provisions contained in the legislation as of the latest date listed below.)
Prepared By: The Professional Staff of the Appropriations Subcommittee on Health and Human Services
BILL: CS/SB 240
INTRODUCER: Health Policy Committee and Senator Book
SUBJECT: Donor Human Milk Bank Services
DATE: March 23, 2021 REVISED:
ANALYST STAFF DIRECTOR REFERENCE ACTION
1. Smith Brown HP Fav/CS
2. McKnight Kidd AHS Pre-meeting
3. AP
Please see Section IX. for Additional Information:
COMMITTEE SUBSTITUTE - Substantial Changes
I. Summary:
CS/SB 240 requires the Department of Health (department) to adopt rules and establish
minimum standards for the regulation of donor human milk banks that must address the
operations of the bank and procedures for donating, distributing, and testing donor human milk
and its derivatives. The bill requires a donor human milk bank operating in this state to comply
with the department standards.
The department can use existing resources to conduct annual inspections of milk banks, provide
technical assistance to these facilities, and develop appropriate guidelines and regulations for
donor human milk banks and milk.
The bill takes effect on July 1, 2021.
II. Present Situation:
Donor Human Breast Milk
According to the federal Centers for Disease Control and Prevention (CDC), breast milk is the
best source of nutrition for most infants.1 Ideally, an infant should be fed his or her own mother’s
breast milk because nutritional components within the mother’s breast milk change to meet the
1
Centers for Disease Control and Prevention, Frequently Asked Questions (FAQ) (May 28, 2020) available at
https://www.cdc.gov/breastfeeding/faq/index.htm (last visited Mar. 4, 2021).
BILL: CS/SB 240 Page 2
infant’s needs as he or she ages.2 Mothers of infants born prematurely are sometimes unable to
produce milk because their bodies aren’t ready, they are too sick, or they’re affected by the stress
of having their premature infant in intensive care.3 Breast milk donated by nursing mothers
provides an option for infants who are unable to receive adequate nutrition from their mother’s
own milk or from commercial infant formulas. Very few illnesses are transmitted via breast milk,
even in cases where someone else’s breast milk is given to another child.4
The American Academy of Pediatrics (AAP) notes that human donor breast milk can be effective
for high-risk and very low birthweight infants if the child’s mother is unable to provide enough
milk.5 Additionally, the World Health Organization (WHO) indicates that human donor breast
milk can prevent some digestive disorders but specifies that any donor milk must come from safe
facilities and is not recommended for sick infants or those weighing less than 1000 grams.6,7 In
the absence of a mother’s milk, the WHO notes that standard formula is also an acceptable
alternative.8
Currently, the federal Food and Drug Administration (FDA) considers human donor breast milk
a “food” source rather than a medical product. The FDA does not have established guidelines or
standards for human donor breast milk or milk banks, although it does recommend consulting
with a health care provider before feeding it to an infant.9 Additionally, the FDA recommends
that the caregiver only feed an infant milk from a source that has screened its donors and has
taken precautions to ensure milk safety, such as a milk bank.10
The Human Milk Banking Association of North America (HMBANA)
Founded in 1985, the Human Milk Banking Association of North America (HMBANA) serves
as the professional organization that accredits nonprofit milk banks in the United States and
Canada.11 The HMBANA is funded by membership fees from its 31 member nonprofit milk
banks, foundation funds, and individual donors.12 There is one HMBANA-accredited location in
2
Id.
3
Naseem S. Miller, Bill aims to get Medicaid coverage for donor breast milk: 'Something like this makes smart policy',
Orlando Sentinel (Mar. 15, 2019) available at https://www.orlandosentinel.com/health/os-ne-mothers-milk-bank-bill-
20190315-story.html (last visited Mar. 2, 2021).
4
Supra note 1.
5
American Academy of Pediatrics Committee on Nutrition, Section on Breastfeeding and Committee on Fetus and Newborn,
Policy Statement, Donor Human Milk for the High-Risk Infant: Preparation, Safety, and Usage Options in the United States
(Jan. 2017) available at https://pediatrics.aappublications.org/content/pediatrics/139/1/e20163440.full.pdf (last visited Mar.
4, 2021).
6
Agency for Health Care Administration, Senate Bill 240 Analysis (Dec. 28, 2020) (on file with Senate Committee on Health
Policy).
7
World Health Organization, Recommendations for the Feeding of low-birth-weight infants in low- and middle-income
countries, available at https://www.who.int/elena/titles/full_recommendations/feeding_lbw/en/ (last visited Mar. 4, 2021).
8
Id.
9
U.S. Food and Drug Administration, Use of Donor Human Milk (Mar. 22, 2018) available at https://www.fda.gov/science-
research/pediatrics/use-donor-human-milk (last visited Mar. 2, 2021).
10
Id.
11
Human Milk Banking Association of North America, About Us, available at https://www.hmbana.org/about-us/ (last
visited Mar. 2, 2021).
12
Id.
BILL: CS/SB 240 Page 3
Florida – the Mother’s Milk Bank of Florida located in Orlando.13 The Mother’s Milk Bank of
Florida supplies pasteurized donor human milk to 38 of the 6814 neonatal intensive care units
(NICUs) in Florida, as well as to medically fragile babies at home who have been prescribed
human donor breast milk.15
Donor human breast milk, that costs approximately $4 an ounce and can add up to over $1,000
per month per infant, is not covered by Florida Medicaid or by most private insurers.16 Through
donations and fundraisers, the Mother’s Milk Bank of Florida provides grants to low-income
families to make donor human breast milk more affordable.17
HMBANA Safety Guidelines18
The HMBANA reports that its member milk banks follow guidelines that were developed by the
HMBANA in consultation with the CDC and the FDA. The FDA reports that it has not been
involved in establishing these voluntary guidelines.19 According to the AHCA, no federal or state
regulations are in place to oversee the Mother’s Milk Bank of Florida.20
Under the HMBANA’s guidelines, before milk is collected, each donor is strictly screened for
medical and lifestyle risk factors and serum is screened for HIV, HTLV, syphilis, and Hepatitis
B and C.21 After the milk is collected, it is mixed and pooled so that each pool includes human
milk from three to five donors. This is done to ensure an even distribution of nutritional
components. Bottles are filled with the pooled milk and then the milk is pasteurized to eliminate
potentially harmful bacteria while retaining the majority of the milk’s beneficial nutrients. Milk
samples are taken during the pasteurization process and cultured to check for bacterial growth.
Any contaminated milk is discarded. No milk is dispensed after pasteurization until a culture is
found to be negative for bacteriological growth. After pasteurization, the milk is frozen and
shipped to hospitals and outpatient families.
III. Effect of Proposed Changes:
Section 1 of the bill creates s. 383.017, F.S., relating to donor human milk banks. The bill
provides that it is the intent of the Legislature to protect the health, safety, and welfare of human
milk donors and recipients of human milk donation and to encourage the use of donor human
milk and donor human milk derivatives.
The bill defines a “donor human milk bank” as any entity or organization operating within this
13
Human Milk Banking Association of North America, Find a Milk Bank, available at https://www.hmbana.org/find-a-milk-
bank/ (last visited Mar. 2, 2021).
14
Supra note 3.
15
Mothers’ Milk Bank of Florida, Covid-19 Update, available at https://milkbankofflorida.org/covid-19-update/ (last visited
Mar. 2, 2021).
16
Supra note 3.
17
Id.
18
Human Milk Banking Association of North America, Milk Processing and Safety, available at
https://www.hmbana.org/our-work/milk-processing-safety.html (last visited Mar. 2, 2021).
19
Supra note 9.
20
Supra note 6.
21
Human Milk Banking Association of North America, Milk Banking and COVID-19 (Apr. 2, 2020) available at
https://www.hmbana.org/file_download/inline/a04ca2a1-b32a-4c2e-9375-44b37270cfbd (last visited Mar. 2, 2021).
BILL: CS/SB 240 Page 4
state that collects, processes, stores, tests, or distributes donor human milk or donor human milk
derivatives.
The bill requires the department to establish minimum standards for the regulation of donor
human milk banks that must address:
 The operation of a donor human milk bank that facilitates the donation, processing, and
distribution of donor human milk and donor human milk derivatives;
 Procedures for donation and distribution of donor human milk and donor human milk
derivatives; and
 Testing of donor human milk and donor human milk derivatives before donation, processing,
and distribution to ensure the absence of adulterants and other contaminants as determined by
the department.
The bill requires a donor human milk bank operating in this state to comply with the department
standards.
The bill requires the department to adopt rules to implement s. 383.017, F.S., as created by the
bill.
Section 2 of the bill takes effect on July 1, 2021.
IV. Constitutional Issues:
A. Municipality/County Mandates Restrictions:
None.
B. Public Records/Open Meetings Issues:
None.
C. Trust Funds Restrictions:
None.
D. State Tax or Fee Increases:
None.
E. Other Constitutional Issues:
None.
V. Fiscal Impact Statement:
A. Tax/Fee Issues:
None.
 BILL: CS/SB 240 Page 5
B. Private Sector Impact:
None.
C. Government Sector Impact:
The department can use existing resources to conduct annual inspections of milk banks,
provide technical assistance to these facilities, and develop appropriate guidelines and
regulations for donor human milk banks and milk.
VI. Technical Deficiencies:
None.
VII. Related Issues:
The bill requires a donor human milk bank operating in this state to comply with the
department’s minimum standards for donor human milk banks, but the department will not
license such entities under the bill and is not given authority to enforce compliance.
VIII. Statutes Affected:
This bill creates section 383.017 of the Florida Statutes.
IX. Additional Information:
A. Committee Substitute – Statement of Substantial Changes:
(Summarizing differences between the Committee Substitute and the prior version of the bill.)
CS by Health Policy on March 10, 2021:
The CS replaces the Medicaid reimbursement authorizations and requirements in the
underlying bill and instead requires:
 The department to adopt rules and establish minimum standards for the regulation of
donor human milk banks that must address the operations of the bank and procedures
for donating, distributing, and testing donor human milk and its derivatives.
 A donor human milk bank operating in this state to comply with the department
standards.
B. Amendments:
None.
This Senate Bill Analysis does not reflect the intent or official position of the bill’s introducer or the Florida Senate.