,,ii #aaith ,,congress #b;d ,session ,s4 #dbbg ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,march #bf1 #bjbf,ms4 ,cortez ,masto 7for herself and ,mr4 ,banks7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to require the ,secretary of ,health and ,human ,services1 acting through the ,assistant ,secretary for ,preparedness and ,response1 to carry out a program under which the ,secretary requires each covered distributor of a highly pathogenic agent to comply with certain logbook requirements1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,preventing ,illegal ,laboratories and ,protecting ,public ,health ,act of #bjbf4 #b4 ,requiring certain distributors of highly pathogenic agents to keep a logbook of sales1 leases1 loans1 and other transfers 7a7 ,program ,the ,secretary shall carry out a program under which the ,secretary requires each covered distributor of a highly pathogenic agent to comply with the logbook requirements of subsection 7c74 7b7 ,list of highly pathogenic agents 7#a7 ,development ,the ,secretary shall develop and maintain a list of all agents that meet the definition of a highly pathogenic agent in subsection 7e74 7#b7 ,initial list ,the ,secretary shall develop the initial list required by paragraph 7#a7 not later than #f months after the date of enactment of this ,act4 7#c7 ,periodic review ,the ,secretary shall annually review and update the list required by paragraph 7#a74 7#d7 ,consultation2 consideration ,in developing and updating the list required by paragraph 7#a71 the ,secretary shall-- 7,a7 consult with relevant agencies1 including the ,centers for ,disease ,control and ,prevention1 the ,national ,institutes of ,health1 the ,department of ,homeland ,security1 the ,department of ,agriculture1 the ,department of the ,interior1 and the ,department of ,defense2 7,b7 take into consideration the latest edition of ,biosafety in ,microbiological and ,biomedical ,laboratories published by the ,centers for ,disease ,control and ,prevention and the ,national ,institutes of ,health 7or any successor to such publication72 and 7,c7 take into consideration the latest edition of ,,nih ,guidelines for ,research ,involving ,recombinant or ,synthetic ,nucleic ,acid ,molecules published by the ,national ,institutes of ,health 7or any successor to such publication74 7c7 ,logbook requirements 7#a7 ,in general ,each covered distributor shall maintain1 in accordance with such criteria and format as the ,secretary may require1 an electronic list 7in this section referred to as a logbook7 of the sales1 leases1 loans1 or other transfers by such distributor of each highly pathogenic agent on the list under subsection 7b74 7#b7 ,contents ,the covered distributor shall1 for each sale1 lease1 loan1 or other transfer referred to in paragraph 7#a71 include in the logbook-- 7,a7 the agent by name2 7,b7 the name1 address1 telephone number1 and email address of the purchaser2 7,c7 other relevant identifying business information of the purchaser1 as the ,secretary determines appropriate2 7,d7 a short description of-- 7i7 the purchaser's intended use of the highly pathogenic agent2 and 7ii7 where the purchaser will house the agent2 7,e7 the date and time of the sale1 lease1 loan1 or other transfer2 7,f7 the method1 date1 and time of transfer of the highly pathogenic agent2 7,g7 a physical or electronic signature of the purchaser2 and 7,h7 such other data elements as the ,secretary may require4 7#c7 ,sale requirements ,in the case of a sale1 lease1 loan1 or other transfer to which paragraph 7#a7 applies1 the covered distributor shall not sell the highly pathogenic agent unless-- 7,a7 the prospective purchaser1 in physical form or electronically in compliance with the ,electronic ,signatures in ,global and ,national ,commerce ,act 7#db ,u4,s4,c4 #gjja et seq47-- 7i7 presents an identification card that provides a photograph and is issued by a ,state or the ,federal ,government1 or a document that1 with respect to identification1 is considered acceptable for purposes of sections #bgd;a4#b7;b77#a77v77,a7 and #bgd;a4#b7;b77#a77v77,b7 of title #h1 ,code of ,federal ,regulations 7or successor regulations72 and 7ii7 verifies by signature in the logbook-- 7,i7 the purchaser's name and address2 7,,ii7 a short description of-- 7aa7 the purchaser's intended use of the agent2 and 7bb7 where the purchaser will house the agent2 7,,iii7 the date and time of the sale1 lease1 loan1 or other transfer2 and 7,,iv7 the method1 date1 and time of transfer of the agent2 and 7,b7 the covered distributor-- 7i7 determines that the name entered in the logbook corresponds to the name provided on the identification card described in subparagraph 7,a77i71 and that the information entered pursuant to subparagraph 7,a77ii7 is correct2 and 7ii7 enters in the logbook the name of the highly pathogenic agent4 7#d7 ,notice ,the covered distributor shall include in the logbook1 in accordance with criteria of the ,secretary1 a notice to purchasers that entering false statements or misrepresentations in the logbook may subject the purchasers to criminal penalties under section #ajja of title #ah1 ,united ,states ,code1 which notice specifies the maximum fine and term of imprisonment under such section4 7#e7 ,duration of maintenance of entries 7,a7 ,retention period ,the covered distributor shall maintain each entry in the logbook for not fewer than #c years after the date on which the entry is made4 7,b7 ,successor entity ,if ownership of a covered distributor changes1 the successor entity shall assume custody of and responsibility for all logbooks for the remainder of the #c-year retention period required by subparagraph 7,a74 7#f7 ,disclosure of logbooks ,the ,secretary shall establish restrictions on disclosure of information in logbooks4 ,such regulations shall-- 7,a7 provide for the disclosure of the information1 as appropriate1 to the ,secretary1 ,federal1 ,state1 local1 ,tribal1 and territorial law enforcement agencies1 and ,state health officials2 and 7,b7 prohibit accessing1 using1 or sharing information in the logbooks for any purpose other than-- 7i7 to ensure compliance with this section2 7ii7 to protect public health and safety2 or 7iii7 to protect national security4 7#g7 ,,foia exemption ,logbooks and any derivative data are exempt from disclosure under section #eeb7;b77#c7 of title #e1 ,united ,states ,code4 7#h7 ,applicability ,a transfer of a highly pathogenic agent between laboratories within a single institution of higher education 7as defined in section #aja of the ,higher ,education ,act of #aife 7#bj ,u4,s4,c4 #ajja77 does not constitute a sale1 lease1 loan1 or other transfer of the agent for purposes of paragraph 7#a74 7#i7 ,audits ,the ,secretary shall establish a risk-based compliance review process by which the ,secretary may conduct audits of logbooks when the ,secretary has cause to believe a violation of this section has occurred4 ,the ,secretary shall focus audits conducted under this paragraph on higher-risk distributors and suspicious patterns4 7d7 ,false statements or misrepresentations by purchasers ,for purposes of section #ajja of title #ah1 ,united ,states ,code1 providing information to a covered distributor for purposes of entering such information in a logbook shall be considered a matter within the jurisdiction of the executive1 legislative1 or judicial branch of the ,government of the ,united ,states4 7e7 ,definitions ,in this section3 7#a7 ,the term covered distributor-- 7,a7 means an entity that sells1 leases1 loans1 or otherwise transfers for value or not for value a highly pathogenic agent1 except that such term does not include an employee or agent of such a distributor2 and 7,b7 includes a publicly funded repository or biobank that sells1 leases1 loans1 or otherwise transfers a highly pathogenic agent1 as described in subparagraph 7,a74 7#b7 ,the term highly pathogenic agent-- 7,a7 subject to subparagraph 7,b71 means a pathogenic agent that meets the criteria of risk group #c or any higher level risk groups as such risk groups are defined in the latest edition of ,,nih ,guidelines for ,research ,involving ,recombinant or ,synthetic ,nucleic ,acid ,molecules published by the ,national ,institutes of ,health 7or any successor to such publication72 and 7,b7 excludes any biological agent or toxin that is regulated under section #cea;,a of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb;a7 or section #bab of the ,agricultural ,bioterrorism ,protection ,act of #bjjb 7#g ,u4,s4,c4 #hdja74 7#c7 ,the term ,secretary means the ,secretary of ,health and ,human ,services1 acting through the ,assistant ,secretary for ,strategic ,preparedness and ,response4 7f7 ,rule of construction ,nothing in this section shall be construed to supersede or otherwise affect the ,federal ,select ,agent ,program under section #cea;,a of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb;a7 and section #bab of the ,agricultural ,bioterrorism ,protection ,act of #bjjb 7#g ,u4,s4,c4 #hdja74 #c4 ,evaluation of high-containment laboratories 7a7 ,in general ,the ,national ,security ,advisor1 in consultation with the ,secretary of ,health and ,human ,services1 the ,secretary of ,agriculture1 the ,secretary of ,defense1 the ,secretary of ,homeland ,security1 the ,secretary of the ,interior1 the ,director of ,national ,intelligence1 and such other ,federal officials as the ,national ,security ,advisor determines appropriate1 shall identify a single ,federal entity to oversee a periodic strategic evaluation of high-containment laboratories in the ,united ,states4 7b7 ,topics ,each strategic evaluation under subsection 7a7 shall include-- 7#a7 an assessment of-- 7,a7 the number1 location1 and mission of high-containment laboratories2 7,b7 the capacity of such existing laboratories to effectively meet national goals to counter threats to biosafety and biosecurity2 7,c7 the physical security measures at high-containment laboratories2 7,d7 the aggregate risks associated with-- 7i7 such existing laboratories2 and 7ii7 expanding the numbers and facilities of such laboratories2 and 7,e7 the type of oversight needed for high-containment laboratories2 and 7#b7 up-to-date national standards1 developed by the ,federal entity identified under subsection 7a71 that-- 7,a7 are developed by the ,federal entity identified under subsection 7a7 in consultation with members of the scientific community1 for the design1 construction1 commissioning1 operation1 and long-term maintenance of high-containment laboratories2 and 7,b7 take into consideration applicable regulations and guidance for high-containment laboratories4 7c7 ,reporting ,upon completion of each strategic evaluation under subsection 7a71 the ,federal entity identified under subsection 7a7 shall submit to the ,president and to ,congress a report on the results of such evaluation and include in each such report recommendations on-- 7#a7 addressing gaps in ,federal oversight of high-containment laboratories2 and 7#b7 utilizing high-containment laboratories for protecting public health and ensuring biosafety and biosecurity in the ,united ,states4 7d7 ,public health biosafety and biosecurity team 7#a7 ,in general ,the ,federal entity identified under subsection 7a7 shall maintain a team1 to be known as the ,public ,health ,biosafety and ,biosecurity ,team1 to serve as a single point of contact for ,state1 local1 ,tribal1 and territorial agencies regarding questions relating to laboratory biosafety and biosecurity4 7#b7 ,establishment ,the ,federal entity identified under subsection 7a7 shall establish the ,public ,health and ,biosecurity ,team1 as required by paragraph 7#a71 not later than one year after such official is first designated4 7#c7 ,duties ,the ,public ,health ,biosafety and ,biosecurity ,team shall be the single point of contact in the ,federal ,government for ,state1 local1 ,tribal1 and territorial agencies on-- 7,a7 issues related to-- 7i7 oversight of high-containment laboratories2 7ii7 the impact of high-containment laboratories on public health2 or 7iii7 connecting ,state1 local1 ,tribal1 and territorial officials with the relevant ,federal agency or agencies on matters related to high-containment laboratories2 and 7,b7 other issues as the ,federal entity identified under subsection 7a7 determines appropriate4 7e7 ,feasibility study 7#a7 ,in general ,the ,federal entity identified under subsection 7a7 shall conduct a feasibility study on establishing and maintaining a database on existing high-containment laboratories in the ,united ,states for the purpose of making such database accessible to ,federal1 ,state1 local1 ,tribal1 and territorial officials4 7#b7 ,database described ,the database considered under paragraph 7#a7 shall be a database designed to include1 with respect to each high-containment laboratory1 the following information3 7,a7 ,the identity of the owners of the laboratory4 7,b7 ,the address of the laboratory4 7,c7 ,the status of any licensing or certification of the laboratory required under ,federal1 ,state1 local1 ,tribal1 or territorial law4 7,d7 ,any legal violations by1 and disciplinary action taken against1 the laboratory4 7,e7 ,such additional information as the ,federal entity identified under subsection 7a7 determines appropriate to protect biosafety and biosecurity4 7#c7 ,report to ,congress ,upon completion of the feasibility study under this subsection1 the ,federal entity identified under subsection 7a7 shall submit to ,congress a report on the results of such study4 7f7 ,definition ,in this section1 the term high-containment laboratory means a laboratory that is suitable for biosafety level #c or any higher biosafety level procedures1 as defined in the latest edition of ,biosafety in ,microbiological and ,biomedical ,laboratories published by the ,centers for ,disease ,control and ,prevention and the ,national ,institutes of ,health 7or any successor to such publication74