Regular Session 2019-2020 House Bill 1001 P.N. 2884

SENATE AMENDED

PRIOR PRINTER'S NO. 1126

PRINTER'S NO. 2884

THE GENERAL ASSEMBLY OF PENNSYLVANIA

HOUSE BILL

No.

1001

Session of

2019

INTRODUCED BY OBERLANDER, YOUNGBLOOD, TOEPEL, KINSEY,

SCHLOSSBERG, KAUFFMAN, SCHLEGEL CULVER, SIMMONS, OTTEN, SIMS,

HILL-EVANS, STRUZZI, T. DAVIS, MULLINS, MARKOSEK, TOOHIL,

FITZGERALD, ULLMAN, DONATUCCI, SNYDER, DALEY, KIM, KLUNK,

ECKER, BROWN, FEE, MALAGARI AND DUSH, MARCH 27, 2019

SENATOR BROOKS, HEALTH AND HUMAN SERVICES, IN SENATE, AS

AMENDED, NOVEMBER 18, 2019

AN ACT

Regulating milk banks that provide donor human milk in this

Commonwealth.

The General Assembly of the Commonwealth of Pennsylvania

hereby enacts as follows:

Section 1. Short title.

This act shall be known and may be cited as the Keystone

Mothers' Milk Bank Act.

Section 2. Legislative intent.

The General Assembly finds and declares as follows:

(1) A mother's own milk is the optimal nutrition for

newborn infants and is a public health goal for the delivery

of food to all infants.

(2) Medically vulnerable infants, including those born

prematurely, with low birth weights or with congenital or

acquired conditions, derive significant health benefits from

receiving human milk.

(3) Necrotizing enterocolitis is a devastating

complication that may result in partial or complete

destruction of the intestinal lining and may lead to both

short-term and life-long health consequences, including

premature death. An all-human-milk diet can significantly

lower the risk of necrotizing enterocolitis in medically

vulnerable infants, including those born prematurely.

(4) Mothers of medically vulnerable babies often face

unique obstacles to producing enough milk for their babies.

When a mother's own milk is not available, donor human milk

can provide a lifesaving health benefit for high-risk infants

as a supplement or bridge when determined to be medically

necessary.

(5) The American Academy of Pediatrics is a strong and

vocal proponent of the use of donor human milk for medically

fragile newborns when provided through properly regulated

milk banks.

(6) Children with a wide range of congenital or acquired

conditions may benefit from the use of donor human milk as a

component of treatment for their medical conditions when

their mother's own milk is unavailable or cannot meet all of

their needs.

(7) The use of donor milk is safe when appropriate

measures are used to screen donors and collect, store and

process the milk for distribution through milk banks licensed

by the Department of Health.

(8) Banked donor milk is predominantly pasteurized to

inactivate pathogens, tested for chemicals or substances that

could be injurious to high-risk infants and frozen for

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storage and shipping. Human milk donors are carefully

medically screened and blood tested to ensure they are

healthy and that the DONOR milk is free from any infectious

diseases or substances that could be harmful to high-risk

infants.

(9) The Human Milk Banking Association of North America

is a professional association that establishes and maintains

current, rigorous guidelines for the operation of human milk

banks throughout North America.

Section 3. Definitions.

The following words and phrases when used in this act shall

have the meanings given to them in this section unless the

context clearly indicates otherwise:

"Act." This act and any rule or regulation adopted under

this act.

"American Academy of Pediatrics." An American professional

association of pediatricians that issues clinical guidelines

regarding the use of donor milk in the delivery of medically

necessary care to newborns and babies.

"Batch." A limited quantity or grouping of donor milk

sharing a common characteristic as further defined by the

department.

"Birth center." A freestanding health care facility for

childbirth where care is provided in the midwifery and wellness

model.

"Collection." The obtaining of donor milk from medically

screened donors by a milk bank licensed in this Commonwealth.

"Committee." The medical advisory committee established by a

milk bank in accordance with section 5(a) 5(A)(6).

"Department." The Department of Health of the Commonwealth.

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"Dispensary." A center that has an agreement with a milk

bank for the distribution of milk from the milk bank by

prescription.

"Distribution." The delivery of medically ordered or

prescribed donor milk to a licensed acute care hospital, birth

center, lactation center, pharmacy, dispensary or, medically

approved outpatient facility OR DIRECTLY TO AN OUTPATIENT by a

milk bank licensed in this Commonwealth.

"Donor." A SUBJECT TO THE PROVISIONS OF SECTION 10, A

lactating woman with an excess supply of human milk who:

(1) voluntarily contributes milk to a milk bank after

being medically screened and approved for milk donation; and

(2) receives no remuneration for the donation of milk.

"Donor milk." Human SUBJECT TO THE PROVISIONS OF SECTION 10,

HUMAN milk derived from a medically screened donor that is

voluntarily donated WITHOUT REMUNERATION to a milk bank and

processed for distribution.

"HMBANA." The Human Milk Banking Association of North

America.

"Lactation center." A center whose sole or main purpose is

to provide support for and education about breastfeeding.

"License." A license issued by the department under this

act.

"Licensed acute care hospital." A hospital that is licensed

by the department under the act of July 19, 1979 (P.L.130,

No.48), known as the Health Care Facilities Act, and is equipped

and staffed for the treatment of medical or surgical conditions,

or both, in the acute or chronic stages, on an inpatient basis

of 24 or more hours.

"Licensee." A milk bank that holds a valid license under

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this act.

"Medically screened." The process of or relating to the

process of evaluating prospective donors by a milk bank to

determine the acceptability of the donor milk based on the

donor's past medical history, medication use, current state of

health and indicated laboratory studies through a process as

approved by the department.

"Milk bank." An entity that collects donor milk from

medically screened human donors and distributes the donor milk

to medically fragile children other than the donor's own child

based on a health care provider's order or prescription, using

storage, processing and shipping methods required by the

department.

"Person." An individual, partnership, association,

corporation, institution, agency or other similar entity.

"Processing." The standards and techniques approved by the

department for inactivating pathogens in donor milk and ensuring

the safety of donor milk.

"Professional association." A professional association that

establishes and requires member compliance with satisfactory

guidelines for the operation of human milk banks as designated

by the department. The term includes HMBANA.

"Professional association guidelines." Guidelines issued by

a professional association that govern the operation of milk

banks belonging to the professional association.

"Satellite milk depot." An entity that has an ongoing

relationship with a licensed milk bank to collect and store

donor milk for shipping to the licensed milk bank.

"Secretary." The Secretary of Health of the Commonwealth.

"Storage." The method of holding and freezing donor milk

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approved by the department in connection with the donor milk's

collection or processing prior to the distribution.

Section 4. Milk banks.

(a) Licensure.--An entity operating or seeking to operate as

a milk bank in this Commonwealth must apply to and be licensed

by the department.

(b) Application.--The department shall issue a license to an

applicant if:

(1) The applicant is in compliance with this act and has

submitted a completed application as developed by the

department that includes all the information required in

section 7 7(D).

(2) The entity meets one of the following requirements:

(i) Is certified as a member in good standing of

HMBANA.

(ii) (I) Is certified as a member in good standing

of a nationally recognized professional organization for

the operation of milk banks.; OR

(iii) (II) Is OTHERWISE determined to be in

compliance with the requirements of this act.

(1) PRIOR TO THE ISSUANCE OF A LICENSE, the department

shall perform an inspection in accordance with section 7(e).

(2) NOTWITHSTANDING THE REQUIREMENT OF PARAGRAPH (1),

THE DEPARTMENT NEED NOT INSPECT THE FACILITY IF:

(I) THE FACILITY HAS A VALID LICENSE OR

ACCREDITATION FROM ANOTHER STATE AND THE DEPARTMENT IS

SATISFIED THAT THE OTHER STATE'S LICENSE ADDRESSES

APPROPRIATE HEALTH AND SAFETY CONCERNS; OR

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(II) THE FACILITY IS REGISTERED AND IN GOOD STANDING

WITH THE UNITED STATES FOOD AND DRUG ADMINISTRATION, AND

THE DEPARTMENT HAS RECEIVED CONFIRMATION THAT THE

FACILITY HAS SATISFACTORILY ADDRESSED ALL OBSERVATIONS

RAISED IN PREVIOUS INSPECTIONS.

(d) Denial.--

(1) An application that has not been approved within six

months of the date of the application shall be deemed denied.

(2) (1) If the department denies an application, or the

application is deemed denied, the department shall provide

the applicant with a written explanation of the reason for

the denial.

(3) (2) An applicant which is denied THAT IS DENIED A

LICENSE is entitled to a hearing if the applicant requests a

hearing within 30 days of the receipt of the denial or within

30 days of the deemed denial if no written explanation is

received.

(e) Fee.--The department shall charge the following fees for

the administration and implementation of this act:

(1) An entity shall pay a $1,000 fee for an initial

license.

(2) A licensee shall pay a $250 fee for each license

renewal.

(f) Expiration.--A license issued under this act shall

expire two years after the date of the issuance of the license.

(g) Renewal.--A license issued under this act may be renewed

in accordance with the regulations promulgated by the department

and upon the payment of a renewal fee.

(h) Suspension and revocation.--

(1) The department may suspend or revoke a license

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issued under this act if the department determines that, in

accordance with section 7 7(H), the licensee is not in

compliance with this act.

(2) Written THE DEPARTMENT SHALL PROVIDE WRITTEN

notification and a hearing shall be provided in accordance

with section 7(h) prior to the suspension or revocation OF A

LICENSE.

(i) Operation prior to effective date.--A milk bank in

operation prior to the effective date of this section may

continue to operate pending a decision on its application THE

MILK BANK'S APPLICATION OR PENDING DECISION ON WHETHER THE

EXEMPTION SPECIFIED IN SECTION 10 APPLIES if an application is

made within 120 days of the later of the following:

(1) The effective date of this section.

(2) The date that an application for a license is first

made available to prospective licensees under this act.

Section 5. Operation of milk bank.

(a) Licensee requirements.--

(1) Each milk bank shall develop and ensure the

implementation of policies and procedures consistent with

professional association guidelines or the requirements of

this act.

(2) NO DONOR MILK OR DONOR-MILK-DERIVED PRODUCT MAY BE

DISTRIBUTED BY A MILK BANK WITHOUT:

(I) TESTING TO ADDRESS ASSOCIATED RISKS AS

IDENTIFIED BY THE GUIDELINES OF THE MILK BANK UNDER

SECTION 7(C); AND

(II) OTHERWISE SATISFYING THE PROVISIONS OF SECTION

(2) (3) Each milk bank shall be operated by a managing

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director responsible for the day-to-day operations of the

milk bank.

(4) A BOARD OF DIRECTORS OR SIMILAR BODY SHALL OVERSEE

THE MILK BANK'S OPERATING, REGULATORY AND COMPLIANCE EFFORTS

AND THE WORK OF THE MANAGING DIRECTOR, THE MEDICAL DIRECTOR

AND THE MEDICAL ADVISORY COMMITTEE.

(5) A MILK BANK SHALL HAVE A MEDICAL DIRECTOR WHO IS A

LICENSED PHYSICIAN WITH A MINIMUM OF FOUR YEARS' EXPERIENCE

IN NEONATOLOGY, PEDIATRICS, BLOOD BANKING, INFECTIOUS DISEASE

OR A RELATED FIELD.

(3) (6) A milk bank shall establish a medical advisory

committee to consult on milk bank operations, which shall be

composed of physicians and other allied health personnel with

experience in neonatology, blood or tissue banking, nutrition

and other related expertise. At least one member of the

committee must have experience in the field of infectious

diseases or biologics manufacturing.

(4) A milk bank shall have a medical director who is a

licensed physician with a minimum of four years' experience

in neonatology, pediatrics, blood banking, infectious disease

or a related field.

(5) A milk bank shall be overseen by a board of

directors or similar body, which shall be responsible for the

oversight of the milk bank's operating, regulatory and

compliance efforts and the work of the managing director, the

medical director and the committee.

(b) Record retention.--Each licensed milk bank A LICENSEE

shall maintain the following records in a manner determined by

the department in an easily accessible location at the milk

bank:

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(1) An individual file on each milk donor, including the

donor's consent to participate in the program and the result

of each laboratory test performed prior to donation and

during the duration of the donation. Direct or indirect

identifying information for an individual donor may not be

disclosed except with the written consent of the individual

donor.

(2) Records providing for the tracing of each donated

milk container from donor to distribution shall include the

following:

(i) Each donor identified by an identification

number.

(ii) The information from each container's affixed

identification tag.

(iii) If used, the identity of the satellite milk

depot, the time and date of receipt by the satellite milk

depot and the information relating to the transportation

of the milk.

(3) The dates that the donor milk was pasteurized,

distributed and used.

(4) Identifying information for milk pooled from

multiple donors, which shall also be separately recorded and

maintained.

(5) Bacteriological testing and dates for each batch of

donor milk.

(6) Refrigeration and freezer temperatures.

(7) Tracking and shipping information for the

distribution of donor milk by facility or by specific

outpatient use.

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LICENSEE shall notify the department within 10 days of

establishing a relationship with a dispensary or satellite milk

depot.

(d) License display.--A licensed milk bank LICENSEE shall

display the license in a prominent place at the milk bank's main

location.

Section 6. Donation, processing and distribution of donor milk.

(a) Donor qualifications.--Potential donors of donor milk

shall:

(1) Be medically screened initially and periodically

reassessed to determine conditions and behaviors that may

affect the quality or nutritional value of the donor's milk

or do harm to the donor herself.

(2) Provide consent for the milk bank to contact the

donor's health care providers, who can grant approval for the

donor and the donor's baby to be medically screened and blood

tested to ensure the health of the potential donor and the

donor's baby and to ensure the donor milk is free of any

chemical, disease or substance that could injure an infant

receiving the milk.

(2) PROVIDE CONSENT FOR THE MILK BANK TO CONTACT:

(I) THE POTENTIAL DONOR'S HEALTH CARE PROVIDERS AND

MEDICALLY SCREEN AND BLOOD TEST THE POTENTIAL DONOR TO

ENSURE THE HEALTH OF THE POTENTIAL DONOR AND TO ENSURE

THE DONOR MILK IS FREE OF ANY CHEMICAL, DISEASE OR

SUBSTANCE THAT COULD INJURE AN INFANT RECEIVING THE MILK.

(II) THE HEALTH CARE PROVIDERS OF THE DONOR'S

BIOLOGICAL BABY TO VERIFY THAT THE BABY IS ACHIEVING

ADEQUATE GROWTH, EXCEPT IN CASES OF BEREAVEMENT,

SURROGACY OR ADOPTION.

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(3) Be excluded from donation for a documented infection

by a bloodborne pathogen or for other acute or chronic

infectious diseases.

(4) Be temporarily precluded from donating milk if the

donor:

(i) Uses medications contraindicated during

breastfeeding or tobacco or other substances as may be

identified by the department.

(ii) Has a systemic chronic disease or nutritional

deficiency as identified by the donor's or the donor's

infant's health care provider.

(iii) Has a history of exposure to possible

environmental contaminants, including lead or mercury.

(iv) Lacks the ability to understand and follow

directions regarding the sanitary collection and storage

of donor milk.

(b) Donor milk processing.--Donor milk shall be processed in

accordance with the following:

(1) An approved pasteurization or processing method,

including the Holder AND VAT pasteurization method or another

method approved by the department, the United States Food and

Drug Administration or a professional organization, shall be

used to inactivate pathogens in donor milk.

(2) Post-pasteurization bacteriologic cultures shall be

performed.

(3) Containers of unprocessed donor milk shall be

labeled with the donor's identification number and the date

of collection. OR THE BAR CODE THAT SUPPLIES THE INFORMATION

REQUIRED UNDER THIS PARAGRAPH.

(4) Frozen, unprocessed donor milk held at a satellite

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milk depot shall identify the location, along with the date

and time of receipt and transportation.

(5) Each container of processed donor milk shall be

properly labeled with the expiration date, batch number and

name of the milk bank specific to the milk contained in the

bottle.

the following:

(1) Proper refrigeration and freezer capability shall be

available at each milk bank, with appropriate thermometer

calibration performed no less frequently than annually. The

thermometer on each refrigerator and freezer used for the

storage of donor milk shall be visually or mechanically

monitored daily for possible fluctuations in temperature that

could impact the quality of the donor milk.

(2) Packing of processed milk shall be documented using

containers that are approved by the United States Food and

Drug Administration as food safe vessels for both heating and

freezing.

(3) Donor milk shall be stored and transported frozen at

a proper temperature and under conditions that protect the

milk from contamination, thawing and refreezing.

(4) Donor milk shall be shipped in clean, insulated

containers using packing material to minimize contamination

of the outside of the bottles during transportation.

Section 7. Duties of department.

(a) Licensure of milk banks.--The department shall:

(1) Regulate the operation of milk banks that handle and

distribute donor milk in this Commonwealth.

(2) Issue licenses to milk banks deemed compliant with

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this act.

(b) Review of professional association guidelines.--

(1) The department shall review and approve professional

association guidelines to ensure that the guidelines in use

maintain the necessary requirements and standards of review

for the safe operation and certification of licensees in this

Commonwealth. If, at any time, the department determines that

the professional association guidelines do not maintain

necessary requirements and standards of review for the safe

operation and certification of licensees, licensees must

satisfy the requirements under paragraph (2).

(2) The department shall adopt standards and

requirements for licensure separate from those of the

professional association guidelines referenced in paragraph

(1) which the department determines are sufficient to

maintain the safe operation and certification of licensees.

a milk bank must satisfy the professional association guidelines

referenced in subsection (b)(1) or the standards and

requirements established by the department under subsection (b)

(2), as applicable.

(d) Application requirements.--The department shall develop

a standard written application for a license, which shall

include at least the following:

(1) The name and location of the milk bank.

(2) The name and address of the managing director

responsible for the milk bank's day-to-day operations and of

the medical director of the milk bank.

(3) The education and experience of each person in a

supervisory or technical role in the operation of the milk

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bank.

(4) A description of the physical facilities, locations,

equipment, sources of materials and methods of processing,

storage and distribution of donor milk.

(5) A description of each technical procedure used in

the routine operation of the milk bank.

(6) Any relationship between the applicant and either a

dispensary or satellite milk depot.

(7) Any other information required by the department.

(e) Inspection of facilities and documentation.--The

(E) INSPECTION OF FACILITIES AND DOCUMENTATION.--THE

FOLLOWING SHALL APPLY:

(1) THE department shall inspect a milk bank's physical

facilities and the physical facilities of a dispensary or

satellite milk depot with which the licensee has a

relationship and shall examine all required documentation

maintained by the milk bank prior to licensure and at any

time deemed necessary by the department.

(2) NOTWITHSTANDING THE REQUIREMENT OF PARAGRAPH (1),

THE DEPARTMENT NEED NOT INSPECT THE FACILITY IF:

(I) THE FACILITY HAS A VALID LICENSE OR

ACCREDITATION FROM ANOTHER STATE AND THE DEPARTMENT IS

SATISFIED THAT THE OTHER STATE'S LICENSE ADDRESSES

APPROPRIATE HEALTH AND SAFETY CONCERNS;

(II) THE FACILITY IS REGISTERED AND IN GOOD STANDING

WITH THE UNITED STATES FOOD AND DRUG ADMINISTRATION, AND

THE DEPARTMENT HAS RECEIVED CONFIRMATION THAT THE

FACILITY HAS SATISFACTORILY ADDRESSED ALL OBSERVATIONS

RAISED IN PREVIOUS INSPECTIONS.

(f) Contents of license.--A license shall display the

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following information:

(1) The name and address of the licensee and the

location of all facilities, dispensaries and affiliated

satellite milk depots authorized under the license.

(2) The name and address of the managing director

responsible for the milk bank's day-to-day operations and of

the medical director of the milk bank.

(3) The signature of the secretary.

(g) Submission of professional association accreditation.--

(1) A licensee belonging to a professional association

shall submit the licensee's professional association

certification information to the department within 30 days of

each inspection and accreditation by the professional

association.

(2) A licensee belonging to a professional association

shall notify the department within 72 hours when membership

in a professional association is terminated for any reason.

(h) Revocations.--Before the department suspends or revokes

a license issued under this act, the department shall provide

written notification to the licensee specifying the reasons for

the revocation or suspension and indicating a time and place for

a hearing to be held within 30 days of the notification.

Section 8. Violations.

(a) Prohibitions.--The following shall be prohibited:

(1) The operation of a milk bank in this Commonwealth by

a person not licensed under this act.

(2) The direct or indirect sale of human milk for profit

or a service fee by a person MILK BANK not licensed under

this act.

(3) Remuneration of value provided to a milk donor by an

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entity A MILK BANK, except as permitted under section 9(c)

10.

(4) THE SALE OR DISTRIBUTION OF DONOR MILK OR ANY DONOR-

MILK-DERIVED PRODUCT IN VIOLATION OF SECTION 5(A)(2).

(b) Penalties.--A violation of this section shall constitute

a misdemeanor of the third degree.

Section 9. Exceptions.

(a) Hospital.--A milk bank located in this Commonwealth and

regulated by the department through a hospital licensure process

shall be exempt from this act if the entity distributes donor

milk solely within that hospital to inpatients or outpatients.

(b) Availability of milk.--If facilitated by a milk bank

licensed under this act which lacks access to donor milk or a

specific type of milk ordered or prescribed to a Pennsylvania

resident, that donor milk may be procured from an out-of-State

milk bank approved ACCREDITED by a professional organization or,

if necessary, APPROVED by the department.

SECTION 10. EXEMPTIONS.

the definitions of "donor" and "donor milk" under section 3, the

department may exempt a milk bank from the requirement that

donors provide DONOR milk voluntarily AND for no remuneration.

In determining whether to grant this exception, the milk bank

must demonstrate to the department that:

(1) the exemption based on this limited circumstance was

sought prior to remunerating donors in this Commonwealth;

(2) the practices are satisfactorily maintained to

protect public health and the safety of the donor milk

recipient, the donor and the donor's baby, based on commonly

accepted medical standards; and

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(3) any additional standards required by the department

reasonably necessary to ensure compliance with paragraph (2)

are implemented. ORDER TO BE GRANTED THIS EXEMPTION, THE MILK

BANK MUST SATISFY THE FOLLOWING:

(1) THE MILK BANK MAY NOT SELL, DONATE OR DISTRIBUTE

DONOR MILK AND DONOR-MILK-DERIVED PRODUCTS FOR WHICH THE

DONOR HAS BEEN REMUNERATED WITHOUT TESTING FOR CONTROLLED

SUBSTANCES AS DETERMINED BY THE DEPARTMENT. THE DEPARTMENT

MAY, AT ANY TIME, REQUIRE ADDITIONAL TESTING FOR DONOR MILK

AND DONOR-MILK-DERIVED PRODUCTS.

(2) THE MILK BANK MAY NOT SELL, DONATE OR DISTRIBUTE

DONOR MILK AND DONOR-MILK-DERIVED PRODUCTS FOR WHICH THE

DONOR HAS BEEN REMUNERATED WITHOUT OBTAINING MEDICAL

VERIFICATION THAT THE DONOR'S BIOLOGICAL INFANT IS ACHIEVING

ADEQUATE GROWTH.

(3) THE MILK BANK MUST MEET OR EXCEED ANY ADDITIONAL

STANDARDS REQUIRED BY THE DEPARTMENT REASONABLY NECESSARY TO

PROTECT PUBLIC HEALTH AND THE RECIPIENT OF THE DONOR MILK,

THE DONOR AND THE DONOR'S BABY.

(B) CONSTRUCTION.--IF THE MILK BANK IS EXEMPT UNDER

SUBSECTION (A), THE DONOR OF THE HUMAN MILK SHALL BE CONSIDERED

A "DONOR" AS DEFINED IN SECTION 3 AND THE HUMAN MILK PROVIDED BY

THE DONOR SHALL BE CONSIDERED "DONOR MILK" AS DEFINED IN SECTION

A MISDEMEANOR OF THE THIRD DEGREE.

(D) APPLICABILITY.--THE PROVISIONS OF SUBSECTION (A)(1) AND

(2) SHALL NOT APPLY TO MILK BANKS THAT DO NOT REMUNERATE DONORS.

Section 10 11. Reports.

Starting in the second odd-numbered year after the effective

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date of this section, and each odd-numbered year thereafter, the

department shall prepare a report on the operation of milk banks

in this Commonwealth in accordance with the following:

(1) The report shall include the following information:

(i) The number of licensed milk banks in this

Commonwealth.

(ii) The address, including the county, for each

licensed milk bank.

(iii) A summary of the amount of milk donated,

processed and distributed by each milk bank organized by

facility type.

(iv) Any other information deemed necessary by the

department.

(2) The report shall be provided to:

(i) The chairperson and minority chairperson of the

Health and Human Services Committee of the Senate.

(ii) The chairperson and minority chairperson of the

Health Committee of the House of Representatives.

Section 11. Licensure application and regulations.

(a) Application.--

(1) Upon the effective date of this subsection, the

department shall create an application for the licensure of

milk banks.

(2) The department shall begin accepting applications

for the licensure of milk banks 120 days after the effective

date of this subsection.

(b) Regulations.--The department may promulgate rules and

regulations to administer and enforce this act.

SECTION 12. LICENSURE APPLICATION.

UPON THE EFFECTIVE DATE OF THIS SECTION, THE DEPARTMENT SHALL

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CREATE AN APPLICATION FOR THE LICENSURE OF MILK BANKS. THE

DEPARTMENT SHALL BEGIN ACCEPTING APPLICATIONS FOR LICENSURE OF

MILK BANKS 120 DAYS AFTER THE EFFECTIVE DATE OF THIS SECTION.

SECTION 13. REGULATIONS.

THE DEPARTMENT MAY PROMULGATE RULES AND REGULATIONS TO

ADMINISTER AND ENFORCE THIS ACT.

Section 12 14. Effective date.

This act shall take effect as follows:

(1) This section and section 11 of this act shall take

effect immediately.

(1) THE FOLLOWING PROVISIONS SHALL TAKE EFFECT

IMMEDIATELY:

(I) THIS SECTION.

(II) SECTION 12.

(III) SECTION 13.

(2) The remainder of this act shall take effect in 120

days.

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