I 
113TH CONGRESS 
2D SESSION 
H. R. 5318 
To ensure certain safety measures are utilized in the interest of public 
health security with respect to labeling and transporting human tissue 
specimen or collection of specimens into interstate commerce. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 31, 2014 
Mr. GOSAR (for himself and Mr. FRANKS of Arizona) introduced the following 
bill; which was referred to the Committee on Energy and Commerce 
A BILL 
To ensure certain safety measures are utilized in the interest 
of public health security with respect to labeling and 
transporting human tissue specimen or collection of 
specimens into interstate commerce. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Label and Transport 
Tissues Safely Act of 2014’’ or as the ‘‘LATTS Act of 
2014’’. 
SEC. 2. IN GENERAL. 
(a) NON-TRANSPLANT TISSUE BANK LICENSE.— 
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(1) PROHIBITION.—No person may introduce or 
deliver for introduction into interstate commerce any 
human tissue specimen for medical research or edu-
cation unless— 
(A) a tissue bank license is in effect for 
the entity introducing the human tissue speci-
men into interstate commerce; 
(B) each package of the human tissue 
specimen is— 
(i) labeled with the proper name of 
the human tissue specimen contained in 
the package; 
(ii) the name, address, and applicable 
license number of the source tissue bank of 
the human tissue specimen; 
(iii) unique donor identifier, tissue 
type, cause of death, serological test re-
sults and any known infectious disease 
agents; 
(iv) a statement about the mandatory 
use of personal protective equipment and 
universal 
precautions 
when 
handling 
human tissue; and 
(v) labeled ‘‘not for transplantation’’; 
and 
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(C) each package of the human tissue 
specimen is wrapped and packaged in such a 
manner that— 
(i) mitigates potential contamination 
and cross contamination; 
(ii) mitigates potential safety hazards; 
(iii) sealed to prevent leakage; and 
(iv) ensures the integrity of the tissue. 
(2) PROCEDURES ESTABLISHED.— 
(A) 
IN
GENERAL.—The 
Secretary 
of 
Health and Human Services shall establish, by 
rule, requirements for the approval, suspension, 
and revocation of non-transplant tissue bank li-
censes. 
(B) APPROVAL.—The Secretary shall ap-
prove a non-transplant tissue bank license ap-
plication— 
(i) on the basis of a demonstration 
that— 
(I) the human tissue specimen 
that is the subject of the application 
is legally donated, properly screened 
for 
communicable 
disease 
agents, 
properly labeled, transported, stored 
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and used according to the donor’s do-
nation authorization; and 
(II) the facility in which the 
human tissue specimen is donated, re-
covered, processed, packed, or held 
meets standards designed to assure 
that the human tissue specimen does 
not pose a communicable disease risk 
to the general public and/or unknown 
communicable disease risk to; and 
(ii) if the applicant (or other appro-
priate person) consents to the inspection of 
the facility that is the subject of the appli-
cation, in accordance with subsection (c) of 
this section. 
(3) REQUIREMENTS
FOR
EXEMPTION.—The 
Secretary shall prescribe requirements under which 
a human tissue specimen shall be exempt from the 
requirements of paragraph (1). 
(b) FALSELY LABELING OR MARKING PACKAGE OR 
CONTAINER; ALTERING LABEL OR MARK.—No person 
shall falsely label or mark any package or container of 
any human tissue specimen or alter any label or mark on 
the package or container of the biological product so as 
to falsify the label or mark. 
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(c) INSPECTION OF ESTABLISHMENT FOR PROPAGA-
TION AND PREPARATION.— 
(1) IN GENERAL.—Any officer, agent, or em-
ployee of the Department of Health and Human 
Services, authorized by the Secretary for the pur-
pose, may during all reasonable hours enter and in-
spect any establishment for the propagation or re-
covery and preparation of any human tissue speci-
men. 
(2) INSPECTION BY NATIONALLY RECOGNIZED 
ACCREDITING BODIES.—Any authorized agent of a 
nationally recognized accrediting body authorized by 
the Secretary for the purpose, may during all rea-
sonable hours enter and inspect any establishment 
for the propagation or recovery and preparation of 
any human tissue specimen. 
(3) RULE OF CONSTRUCTION.—Nothing in this 
subsection or Act limits any existing authority of the 
Attorney General, any State Attorney General or 
local law enforcement to enter and inspect any es-
tablishment for the propagation or recovery and 
preparation of any human tissue. 
(d) RECALL OF SPECIMEN PRESENTING IMMINENT 
HAZARD; VIOLATIONS.— 
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(1) RECALL.—Upon a determination that a 
human tissue specimen or collection of specimens li-
censed under this section presents an imminent or 
substantial hazard to the public health, the Sec-
retary shall issue an order immediately ordering the 
recall of such batch, lot, or other quantity of such 
product. An order under this paragraph shall be 
issued in accordance with section 554 of title 5. 
(2) VIOLATIONS.—Any violation of paragraph 
(1) shall subject the violator to a civil penalty of up 
to $10,000 per day of violation. The amount of a 
civil penalty under this paragraph shall, effective 
December 1 of each year beginning 1 year after the 
effective date of this paragraph, be increased by the 
percent change in the Consumer Price Index for the 
base quarter of such year over the Consumer Price 
Index for the base quarter of the preceding year, ad-
justed to the nearest 1⁄10 of 1 percent. For purposes 
of this paragraph, the term ‘‘base quarter’’, as used 
with respect to a year, means the calendar quarter 
ending on September 30 of such year and the price 
index for a base quarter is the arithmetical mean of 
such index for the 3 months comprising such quar-
ter. 
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(e) PENALTIES FOR OFFENSES.—Whoever violates 
any of the provisions of this section shall be imprisoned 
not more than 1 year, or fined not more than $500, or 
both. Section 3571 of title 18, United States Code shall 
not apply to an offense under this subsection. 
(f) CONSTRUCTION WITH OTHER LAWS.—Nothing 
contained in this Act shall be construed as in any way 
affecting, modifying, repealing, or superseding under any 
existing provisions under current Federal law. 
(g) HUMAN TISSUE SPECIMEN DEFINED.—In this 
section, the term ‘‘non-transplant tissue specimen’’ means 
legally donated anatomical segments, cells, collection of 
cells, bodily fluids, or the complete body that are recovered 
for medical research and education. The term does not in-
clude anything that would qualify as a biological product 
under the Public Health Service Act. 
Æ 
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