I
119THCONGRESS
1
STSESSION H. R. 2589
To amend the Public Health Service Act to ensure the consensual donation
and respectful disposition of human bodies and human body parts do-
nated or transferred for education, research, or the advancement of
medical, dental, or mortuary science and not for use in human transplan-
tation, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
APRIL2, 2025
Mr. B
ILIRAKIS(for himself and Mrs. FLETCHER) introduced the following bill;
which was referred to the Committee on Energy and Commerce
A BILL
To amend the Public Health Service Act to ensure the con-
sensual donation and respectful disposition of human
bodies and human body parts donated or transferred
for education, research, or the advancement of medical,
dental, or mortuary science and not for use in human
transplantation, and for other purposes.
Be it enacted by the Senate and House of Representa-1
tives of the United States of America in Congress assembled, 2
SECTION 1. SHORT TITLE. 3
This Act may be cited as the ‘‘Consensual Donation 4
and Research Integrity Act of 2025’’. 5
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SEC. 2. HUMAN BODIES AND HUMAN BODY PARTS DO-1
NATED OR TRANSFERRED FOR EDUCATION, 2
RESEARCH, OR THE ADVANCEMENT OF MED-3
ICAL, DENTAL, OR MORTUARY SCIENCE AND 4
NOT FOR USE IN HUMAN TRANSPLANTATION. 5
(a) I
NGENERAL.—Title III of the Public Health 6
Service Act (42 U.S.C. 241 et seq.) is amended by insert-7
ing after section 373 the following new section: 8
‘‘SEC. 373A. HUMAN BODIES AND HUMAN BODY PARTS DO-9
NATED OR TRANSFERRED FOR EDUCATION, 10
RESEARCH, OR THE ADVANCEMENT OF MED-11
ICAL, DENTAL, OR MORTUARY SCIENCE AND 12
NOT FOR USE IN HUMAN TRANSPLANTATION. 13
‘‘(a) R
EGISTRATION.— 14
‘‘(1) I
N GENERAL.—A person who acquires 15
human bodies and sells for profit a whole human 16
body or human body part in or affecting interstate 17
commerce shall register with the Secretary at such 18
time and in such manner as the Secretary may re-19
quire. 20
‘‘(2) E
XCEPTION.—Paragraph (1) does not 21
apply to the Organ Procurement and Transplan-22
tation Network under section 372 and any entity 23
that is a member of the Network pursuant to section 24
121.3 of title 42, Code of Federal Regulations (or 25
any successor regulations), funeral service profes-26
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sionals in regard to the preparation, transportation, 1
and final disposition of the human body or body 2
parts, and schools of medicine, dentistry, and mor-3
tuary science and research, training organizations, 4
and other entities that do not sell for profit a whole 5
body or body part. 6
‘‘(3) C
ONTENTS OF APPLICATION .—An appli-7
cant for registration or renewal of registration under 8
this section shall submit an application to the Sec-9
retary containing such information as the Secretary 10
may by regulation require on the activities to be car-11
ried out pursuant to the registration. Unless the 12
Secretary specifies otherwise by regulation, an appli-13
cation shall include— 14
‘‘(A) the name of the applicant, including 15
all trade names under which the applicant con-16
ducts business; 17
‘‘(B) the date on which the applicant first 18
began or will begin commencing activities de-19
scribed in paragraph (1); 20
‘‘(C) a list of all addresses at which the 21
applicant conducts business; 22
‘‘(D) a description of the premises and 23
equipment used by the applicant; 24
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‘‘(E) a description of the types of service 1
provided by the applicant; 2
‘‘(F) an identification of a representative 3
of the applicant who has attained the age of 18 4
and has the authority to ensure that the appli-5
cant complies with this section; 6
‘‘(G) an assurance that the Secretary will 7
be permitted to inspect the premises and 8
records of the applicant at the times and in the 9
manners prescribed under subsection (b); 10
‘‘(H) an assurance that the applicant will 11
keep records in accordance with subsection (c); 12
‘‘(I) an assurance that the applicant will 13
label and package all human bodies or human 14
body parts in accordance with subsection (d); 15
and 16
‘‘(J) an assurance that the applicant will 17
limit the use and disclosure of information in 18
accordance with the regulations promulgated 19
pursuant to subsection (e). 20
‘‘(4) F
EES.— 21
‘‘(A) A
UTHORITY.—The Secretary shall es-22
tablish a fee for registration under paragraph 23
(1) and renewal under paragraph (5) in an 24
amount in accordance with subparagraph (B). 25
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‘‘(B) AMOUNT.—The Secretary shall deter-1
mine the amount of the fees authorized by sub-2
paragraph (A) on an annual basis based on the 3
projected cost of implementing and enforcing 4
this section, including the cost of inspections 5
under subsection (b). 6
‘‘(C) C
OLLECTIONS AND APPROPRIATIONS 7
ACTS.—The fees authorized by subparagraph 8
(A) shall be available for obligation only to the 9
extent and in the amounts provided in advance 10
in appropriations Acts. 11
‘‘(5) R
EGISTRATION RENEWAL .—The Secretary 12
shall require that the registration of a registrant be 13
renewed by such registrant at such intervals as the 14
Secretary determines appropriate. 15
‘‘(6) C
HANGE OF INFORMATION .—Not later 16
than 30 days after any change of any information 17
listed in paragraph (3), an applicant or registrant 18
shall notify the Secretary of such change in writing 19
as prescribed by regulation by the Secretary. 20
‘‘(b) I
NSPECTIONS.—The Secretary shall inspect at 21
regular intervals (to be prescribed by the Secretary) the 22
premises described in subsection (a)(3)(D). 23
‘‘(c) R
ECORDKEEPING.— 24
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‘‘(1) IN GENERAL.—A registrant shall maintain 1
a record for each case in which the registrant ac-2
quires a human body or human body part. 3
‘‘(2) R
ECORD REQUIREMENTS .—A record under 4
paragraph (1) shall contain such information as the 5
Secretary may by regulation require. Unless the Sec-6
retary specifies otherwise by regulation, a record 7
under paragraph (1) shall include the following: 8
‘‘(A) Documentation that the donor has 9
knowingly consented to the transfer of the 10
human body or human body part (not for use 11
in transplantation) involved for education, re-12
search, or the advancement of medical, dental, 13
or mortuary science in accordance with all ap-14
plicable laws pertaining to the disposition of 15
human remains. 16
‘‘(B) Documentation that the donor has 17
been informed of the obligation of the reg-18
istrant under subsection (e) to dispose of the 19
human body or human body part. 20
‘‘(C) The date and time of the donation or 21
transfer from the donor. 22
‘‘(D) The name of the person, including 23
any trade or business name, who transferred 24
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the human body or human body part to the reg-1
istrant, if applicable. 2
‘‘(E) The full name and most recent ad-3
dress of the donor. 4
‘‘(F) A description of the human body or 5
human body part being acquired or transferred. 6
‘‘(G) The medical history of the donor, in-7
cluding the autopsy report if an autopsy was 8
conducted. 9
‘‘(H) The identity and address of each per-10
son that has been in possession of the human 11
body or human body part prior to the reg-12
istrant, including any funeral home, coroner, 13
hospital, organ procurement organization, or 14
tissue bank. 15
‘‘(I) Documentation of the use and disposi-16
tion of each human body or human body part 17
by the registrant. 18
‘‘(J) Documentation of the name and ad-19
dress of each person to whom the registrant 20
transfers such human body or human body 21
part. 22
‘‘(d) L
ABELING ANDPACKAGING.— 23
‘‘(1) I
N GENERAL.—A registrant shall ensure 24
that all human bodies and human body parts in the 25
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possession of, or transferred by, a registrant are la-1
beled and packaged in accordance with paragraphs 2
(2) and (3) and that a proper chain of custody is 3
maintained. 4
‘‘(2) L
ABELING REQUIREMENTS .— 5
‘‘(A) P
LACEMENT.—The labeling required 6
by paragraph (1) shall be affixed beneath the 7
outer packaging. 8
‘‘(B) C
ONTENTS.—The labeling required 9
by paragraph (1) shall contain such information 10
as the Secretary may by regulation require con-11
sistent with any applicable Federal privacy pro-12
visions. Unless the Secretary specifies otherwise 13
by regulation, a label under paragraph (1) shall 14
include the following: 15
‘‘(i) The proper name of the donor. 16
‘‘(ii) A description of the contents of 17
the packaging, indicating whether it is a 18
human body or human body parts, includ-19
ing a list of all such parts. 20
‘‘(iii) The name, address, and any ap-21
plicable license or registration number of 22
the person transferring the human body or 23
human body part. 24
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‘‘(iv) The tissue types of the human 1
body or human body part. 2
‘‘(v) The cause of death of the donor, 3
if applicable and known. 4
‘‘(vi) Serological test results, if any 5
such results exist. 6
‘‘(vii) Record of the presence of radio-7
active materials or implants. 8
‘‘(viii) Any known infectious disease 9
agents of such human body or human body 10
part. 11
‘‘(ix) A statement about the use of 12
personal protective equipment and uni-13
versal precautions when handling a human 14
body or human body part as required by 15
law. 16
‘‘(x) The statement ‘not for transplan-17
tation’. 18
‘‘(3) P
ACKAGING REQUIREMENTS .—Each 19
human body or human body part described in para-20
graph (1) shall be wrapped and packaged in such 21
manner as the Secretary may by regulation require. 22
Unless the Secretary specifies otherwise by regula-23
tion, each such human body or human body part 24
shall be wrapped and packaged in a manner that— 25
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‘‘(A) mitigates potential contamination and 1
cross contamination; 2
‘‘(B) mitigates potential safety hazards; 3
‘‘(C) is sealed to prevent leakage; and 4
‘‘(D) ensures the integrity of the human 5
body or human body part. 6
‘‘(e) L
IMITATIONS ONUSE ANDDISCLOSURE OFIN-7
FORMATION.—Individually identifiable information relat-8
ing to the donor of a human body or human body part 9
acquired or transferred pursuant to a registration under 10
this section shall be used and disclosed only for such pur-11
poses (including the return of remains for burial) as the 12
Secretary may explicitly authorize by regulation. 13
‘‘(f) D
ISPOSITION.—The registrant shall ensure the 14
proper disposition of a human body or human body part, 15
in accordance with applicable Federal and State law, by— 16
‘‘(1) returning the human body or human body 17
part to a relative or personal representative of the 18
donor or carrying out the disposition of such human 19
body or human body part in accordance with the 20
written instructions of the person or persons with 21
the right to control the disposition of the human 22
body or body parts; or 23
‘‘(2) if the registrant is transferring the human 24
body or human body part to another person, con-25
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tracting with such person to assume the obligation 1
described in paragraph (1). 2
‘‘(g) V
IOLATIONS.— 3
‘‘(1) I
N GENERAL.—Any person who violates a 4
requirement of this section shall be fined in accord-5
ance with title 18, United States Code. 6
‘‘(2) R
EVOCATION OF REGISTRATION .—The 7
Secretary may suspend or revoke the registration of 8
any registrant found to be in violation of this sec-9
tion. 10
‘‘(3) A
LTERATION OR FALSIFICATION OF 11
LABEL.—It shall be a violation of this section for 12
any person to alter or falsify any information in a 13
label required by subsection (d). 14
‘‘(h) D
EFINITIONS.—In this section: 15
‘‘(1) D
ONOR.—The term ‘donor’ means a per-16
son who has knowingly consented in accordance with 17
applicable law to the transfer of such person’s de-18
ceased body or deceased or living body part (not for 19
use in transplantation) for education, research, or 20
the advancement of medical, dental, or mortuary 21
science. 22
‘‘(2) E
DUCATION.—The term ‘education’ means 23
the use of a human body or body parts for teaching 24
or training individuals, including medical, dental, or 25
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mortuary science students or professionals, with re-1
gard to the anatomy and characteristics of the 2
human body, disease detection, and such other uses 3
as may be specified by the Secretary by regulation. 4
‘‘(3) H
UMAN BODY.—The term ‘human body’ 5
means a deceased human body. 6
‘‘(4) H
UMAN BODY PART .—The terms ‘human 7
body part’ or ‘body part’ mean an organ, tissue, eye, 8
bone, blood vessel or any other portion of a deceased 9
or living human body that is subject to an anatom-10
ical gift or other transfer made pursuant to State 11
law, but do not include— 12
‘‘(A) blood drawn for medical purposes; or 13
‘‘(B) a growing cell line. 14
‘‘(5) R
ESEARCH.—The term ‘research’ does not 15
include an autopsy or examination, conducted as 16
part of a criminal investigation.’’. 17
(b) R
ULE OFAPPLICABILITY.—The amendments 18
made by this section shall apply with respect to any acqui-19
sition or transfer of a human body or human body parts 20
after the date that is 2 years after the date of the enact-21
ment of this Act. 22
Æ
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