,i #aacth ,,congress #b;d ,session ,h4 ,r4 #ecah ,,in ,,the ,,house ,,of ,,representatives ,july #ca1 #bjad ,mr4 ,gosar 7for himself and ,mr4 ,franks of ,arizona7 introduced the following bill2 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 commerce4 #a4 ,short title ,this ,act may be cited as the ,label and ,transport ,tissues ,safely ,act of #bjad or as the ,,latts ,act of #bjad4 #b4 ,in general 7a7 ,non-,transplant ,tissue ,bank license 7#a7 ,prohibition ,no person may introduce or deliver for introduction into interstate commerce any human tissue specimen for medical research or education unless-- 7,a7 a tissue bank license is in effect for the entity introducing the human tissue specimen into interstate commerce2 7,b7 each package of the human tissue specimen is-- 7i7 labeled with the proper name of the human tissue specimen contained in the package2 7ii7 the name1 address1 and applicable license number of the source tissue bank of the human tissue specimen2 7iii7 unique donor identifier1 tissue type1 cause of death1 serological test results and any known infectious disease agents2 7iv7 a statement about the mandatory use of personal protective equipment and universal precautions when handling human tissue2 and 7v7 labeled not for transplantation2 and 7,c7 each package of the human tissue specimen is wrapped and packaged in such a manner that-- 7i7 mitigates potential contamination and cross contamination2 7ii7 mitigates potential safety hazards2 7iii7 sealed to prevent leakage2 and 7iv7 ensures the integrity of the tissue4 7#b7 ,procedures established 7,a7 ,in general ,the ,secretary of ,health and ,human ,services shall establish1 by rule1 requirements for the approval1 suspension1 and revocation of non-transplant tissue bank licenses4 7,b7 ,approval ,the ,secretary shall approve a non-transplant tissue bank license application-- 7i7 on the basis of a demonstration that-- 7,i7 the human tissue specimen that is the subject of the application is legally donated1 properly screened for communicable disease agents1 properly labeled1 transported1 stored and used according to the donor's donation authorization2 and 7,,ii7 the facility in which the human tissue specimen is donated1 recovered1 processed1 packed1 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 to2 and 7ii7 if the applicant 7or other appropriate person7 consents to the inspection of the facility that is the subject of the application1 in accordance with subsection 7c7 of this section4 7#c7 ,requirements for exemption ,the ,secretary shall prescribe requirements under which a human tissue specimen shall be exempt from the requirements of paragraph 7#a74 7b7 ,falsely labeling or marking package or container2 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 mark4 7c7 ,inspection of establishment for propagation and preparation 7#a7 ,in general ,any officer1 agent1 or employee of the ,department of ,health and ,human ,services1 authorized by the ,secretary for the purpose1 may during all reasonable hours enter and inspect any establishment for the propagation or recovery and preparation of any human tissue specimen4 7#b7 ,inspection by nationally recognized accrediting bodies ,any authorized agent of a nationally recognized accrediting body authorized by the ,secretary for the purpose1 may during all reasonable hours enter and inspect any establishment for the propagation or recovery and preparation of any human tissue specimen4 7#c7 ,rule of construction ,nothing in this subsection or ,act limits any existing authority of the ,attorney ,general1 any ,state ,attorney ,general or local law enforcement to enter and inspect any establishment for the propagation or recovery and preparation of any human tissue4 7d7 ,recall of specimen presenting imminent hazard2 violations 7#a7 ,recall ,upon a determination that a human tissue specimen or collection of specimens licensed under this section presents an imminent or substantial hazard to the public health1 the ,secretary shall issue an order immediately ordering the recall of such batch1 lot1 or other quantity of such product4 ,an order under this paragraph shall be issued in accordance with section #eed of title #e4 7#b7 ,violations ,any violation of paragraph 7#a7 shall subject the violator to a civil penalty of up to #aj1jjj per day of violation4 ,the amount of a civil penalty under this paragraph shall1 effective ,december #a of each year beginning #a year after the effective date of this paragraph1 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 year1 adjusted to the nearest #a_/aj of #a percent4 ,for purposes of this paragraph1 the term base quarter1 as used with respect to a year1 means the calendar quarter ending on ,september #cj of such year and the price index for a base quarter is the arithmetical mean of such index for the #c months comprising such quarter4 7e7 ,penalties for offenses ,whoever violates any of the provisions of this section shall be imprisoned not more than #a year1 or fined not more than #ejj1 or both4 ,section #cega of title #ah1 ,united ,states ,code shall not apply to an offense under this subsection4 7f7 ,construction with other laws ,nothing contained in this ,act shall be construed as in any way affecting1 modifying1 repealing1 or superseding under any existing provisions under current ,federal law4 7g7 ,human tissue specimen defined ,in this section1 the term non-transplant tissue specimen means legally donated anatomical segments1 cells1 collection of cells1 bodily fluids1 or the complete body that are recovered for medical research and education4 ,the term does not include anything that would qualify as a biological product under the ,public ,health ,service ,act4