I 

115TH CONGRESS 

1ST SESSION H. R. 2022 

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 

APRIL 6, 2017 

Mr. GOSAR 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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Label and Transport 

5 Tissues Safely Act of 2017’’ or as the ‘‘LATTS Act of 

6 2017’’. 

7 SEC. 2. IN GENERAL. 

8 (a) NON-TRANSPLANT TISSUE BANK LICENSE.— 


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1 (1) PROHIBITION.—No person may introduce or 

2 deliver for introduction into interstate commerce any 

3 human tissue specimen for medical research or edu4 cation unless— 

5 (A) a non-transplant tissue bank license is 

6 in effect for the entity introducing the human 

7 tissue specimen into interstate commerce; 

8 (B) each package of the human tissue 

9 specimen is labeled with— 

10 (i) the proper name of the human tis11 sue specimen contained in the package; 

12 (ii) the name, address, and applicable 

13 license number of the source tissue bank of 

14 the human tissue specimen; 

15 (iii) a unique donor identifier, the tis16 sue type, the cause of death, serological 

17 test results, and any known infectious dis18 ease agents; 

19 (iv) a statement about the mandatory 

20 use of personal protective equipment and 

21 universal precautions when handling 

22 human tissue; and 

23 (v) the statement ‘‘not for transplan24 tation’’; and 


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1 (C) each package of the human tissue 

2 specimen is wrapped and packaged in a manner 

3 that— 

4 (i) mitigates potential contamination 

5 and cross contamination; 

6 (ii) mitigates potential safety hazards; 

7 (iii) is sealed to prevent leakage; and 

8 (iv) ensures the integrity of the tissue. 

9 (2) PROCEDURES ESTABLISHED.— 

10 (A) IN GENERAL.—The Secretary of 

11 Health and Human Services shall establish, by 

12 rule, requirements for the approval, suspension, 

13 and revocation of non-transplant tissue bank li14 censes. 

15 (B) APPROVAL.—The Secretary shall ap16 prove a non-transplant tissue bank license ap17 plication— 

18 (i) on the basis of a demonstration 

19 that— 

20 (I) the human tissue specimens 

21 of the applicant are legally donated, 

22 properly screened for communicable 

23 disease agents, properly labeled, 

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1 cording to the donor’s donation au2 thorization; 

3 (II) each facility in which the 

4 human tissue specimens of the appli5 cant are donated, recovered, proc6 essed, packed, or held meets stand7 ards designed to ensure that the 

8 human tissue specimens do not pose a 

9 communicable disease risk to the gen10 eral public; and 

11 (III) the applicant creates, com12 piles, and maintains a complete record 

13 on each donor from which it recovers 

14 a human body or human tissue speci15 men for educational or research pur16 poses, which record shall include, at a 

17 minimum— 

18 (aa) documentation dem19 onstrating that the donor or the 

20 agent making the donation on 

21 the donor’s behalf has knowingly 

22 consented to the anatomical do23 nation for educational or re24 search purposes; 


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1 (bb) documentation showing 

2 that the donor or the agent mak3 ing the donation on the donor’s 

4 behalf has been informed as to 

5 whether the body or human tis6 sue specimens shall be returned 

7 to a relative or personal rep8 resentative or whether the appli9 cant shall arrange and carry out 

10 the disposition of the human 

11 body or human tissue specimens; 

12 (cc) documentation of the 

13 identity and address of each enti14 ty which has been in possession 

15 of the human body or human tis16 sue specimen before the applicant 

17 took possession, such as a fu18 neral home, coroner, hospital, 

19 organ procurement organization, 

20 or tissue bank; and 

21 (dd) documentation on the 

22 use and disposition of each 

23 human body or human tissue 

24 specimen, including the name 

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1 tity that receives the human body 

2 or human tissue specimen di3 rectly from the applicant; and 

4 (ii) only if the applicant (or other ap5 propriate person) consents to the inspec6 tion of the facility that is the subject of the 

7 application, in accordance with subsection 

8 (c). 

9 (3) REQUIREMENTS FOR EXEMPTION.—The 

10 Secretary shall prescribe requirements under which 

11 a human tissue specimen shall be exempt from the 

12 requirements of paragraph (1). 

13 (b) FALSELY LABELING OR MARKING PACKAGE OR

14 CONTAINER; ALTERING LABEL OR MARK.—No person 

15 shall falsely label or mark any package or container of 

16 any human tissue specimen or alter any label or mark on 

17 the package or container of the human tissue specimen 

18 so as to falsify the label or mark. 

19 (c) INSPECTION OF FACILITIES.— 

20 (1) IN GENERAL.—Any officer, agent, or em21 ployee of the Department of Health and Human 

22 Services, authorized by the Secretary for the pur23 pose, may during all reasonable hours enter and in24 spect any facility that is subject to a non-transplant 

25 tissue bank license under this section. 


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1 (2) INSPECTION BY NATIONALLY RECOGNIZED

2 ACCREDITING BODIES.—Any authorized agent of a 

3 nationally recognized accrediting body authorized by 

4 the Secretary for the purpose, may during all rea5 sonable hours enter and inspect any such facility. 

6 (3) RULE OF CONSTRUCTION.—Nothing in this 

7 Act limits any existing authority of the Attorney 

8 General, any State Attorney General, or local law 

9 enforcement to enter and inspect any such facility. 

10 (d) RECALL OF SPECIMEN PRESENTING IMMINENT

11 HAZARD; VIOLATIONS.— 

12 (1) RECALL.—Upon a determination that a 

13 human tissue specimen or collection of specimens of 

14 a tissue bank licensed under this section presents an 

15 imminent or substantial hazard to the public health, 

16 the Secretary shall issue an order immediately order17 ing the recall of such batch, lot, or other quantity 

18 of such product. An order under this paragraph 

19 shall be issued in accordance with section 554 of 

20 title 5, United State Code. 

21 (2) VIOLATIONS.—Any violation of a recall 

22 order under paragraph (1) shall subject the violator 

23 to a civil penalty of up to $10,000 per day of viola24 tion. The amount of a civil penalty under this para25 graph shall, effective December 1 of each calendar 


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1 year beginning 1 year or more after the effective 

2 date of this paragraph, be increased by the percent 

3 change in the Consumer Price Index for the base 

4 quarter of such year over the Consumer Price Index 

5 for the base quarter of the preceding year, adjusted 

to the nearest 1 6 ⁄10 of 1 percent. For purposes of this 

7 paragraph, the term ‘‘base quarter’’, as used with 

8 respect to a year, means the calendar quarter ending 

9 on September 30 of such year, and the price index 

10 for a base quarter is the arithmetical mean of such 

11 index for the 3 months comprising such quarter. 

12 (e) PROHIBITIONS OF SALES AND PURCHASES OF

13 HUMAN TISSUE SPECIMEN.—It shall be unlawful for any 

14 person to knowingly sell, acquire, receive, or otherwise 

15 transfer any human tissue specimen for valuable consider16 ation if the transfer affects interstate commerce. 

17 (f) PENALTIES FOR OFFENSES.—Whoever violates 

18 any of the provisions of this section shall be imprisoned 

19 not more than 1 year, or fined not more than $10,000, 

20 or both. Section 3571 of title 18, United States Code, shall 

21 not apply to an offense under this section. 

22 (g) CONSTRUCTION WITH OTHER LAWS.—Nothing 

23 in this Act (other than subsection (f)) shall be construed 

24 as in any way affecting, modifying, repealing, or super25 seding any other provision of Federal law. 


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1 (h) DEFINITIONS.—For the purposes of this section: 

2 (1) Unless the context indicates otherwise, the 

3 term ‘‘agent’’ means the person who is expressly au4 thorized to make an anatomical donation on the do5 nor’s behalf under State law. 

6 (2) The term ‘‘donor’’ means a person whose 

7 body or whose human tissue specimen is the subject 

8 of an anatomical donation. 

9 (3) The term ‘‘human tissue specimen’’— 

10 (A) means legally donated anatomical seg11 ments, cells, or body fluids (including a com12 plete body) that are recovered for medical re13 search or education; and 

14 (B) does not include a biological product 

15 (as defined in section 351 of the Public Health 

16 Services Act (42 U.S.C. 262)). 

17 (4) The term ‘‘valuable consideration’’ means 

18 something of value, but does not include the reason19 able payments associated with the removal, transpor20 tation, processing, preservation, quality control, stor21 age, and lawful disposition of human tissue speci22 mens. 

Æ 


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