,i #aaith ,,congress #b;d ,session ,h4 ,r4 #ajaig ,,in ,,the ,,house ,,of ,,representatives ,august #ca1 #bjbf,mr4 ,pfluger 7for himself and ,ms4 ,houlahan7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to improve the security of nucleic acid synthesis in interstate and foreign commerce1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,biosecurity ,modernization and ,innovation ,act4 #b4 ,requirements for covered entities with respect to high-risk sequences 7a7 ,in general ,a covered entity shall establish a program of reasonable administrative and technical protocols to carry out1 with respect to any nucleic acid sequence made available in interstate or foreign commerce by such covered entity1 the following requirements3 7#a7 ,verify the identity of any buyer or prospective buyer of such a nucleic acid sequence1 including with respect to any such nucleic acid sequence generated by a benchtop nucleic acid synthesizer4 7#b7 ,establish the purpose for which any such buyer or prospective buyer seeks to obtain any such nucleic acid sequence4 7#c7 ,identify whether such a nucleic acid sequence1 including any such nucleic acid sequence generated by a benchtop nucleic acid synthesizer1 is a covered sequence as determined by the ,secretary under paragraph 7#a77;,a7 of subsection 7e71 and on the list established and made available under paragraph 7#a77;,c7 of such subsection4 7#d7 ,establish risk-based criteria for refusing the sale of a covered sequence to a buyer1 prospective buyer1 or any combination thereof1 and document each instance of refusal by the covered entity in accordance with such criteria4 7#e7 ,provide timely notification to the ,secretary if the covered entity has a reasonable belief that such a buyer or prospective buyer is likely to use a covered sequence in a manner that poses a high risk to the national security of the ,united ,states or to the security and safety of persons in the ,united ,states4 7#f7 ,ensure regular independent assessment of compliance by the covered entity with paragraphs 7#a7 through 7#e7 and paragraph 7#g71 including through adversarial testing1 third-party certifications1 independent internal or external audits1 direct examination by the ,secretary1 or any combination thereof4 7#g7 ,maintain records sufficient to demonstrate to the ,secretary compliance with the requirements described in paragraphs 7#a7 through 7#f7 for a period of not less than #e years1 as practicable4 7b7 ,guidance 7#a7 ,in general ,not later than #ahj days after the date of the enactment of this ,act1 the ,secretary1 in consultation with relevant heads of other ,federal departments1 agencies1 or offices1 as appropriate1 shall issue guidance that identifies the following3 7,a7 ,approaches1 best practices1 frameworks1 and methods that may be implemented1 alone or in combination1 by a covered entity to satisfy the requirements under subsection 7a74 7,b7 ,how a covered entity may ensure regular independent assessment of compliance as described in paragraph 7#f7 of such subsection4 7,c7 ,what constitutes a timely notification under paragraph 7#e7 of such subsection1 including by when and in what manner a covered entity is required to provide such a notification to the ,secretary4 7#b7 ,enforcement plan ,not later than #a year after the date of the enactment of this ,act1 the ,secretary shall issue guidance relating to the priorities of the ,secretary for enforcing the requirements under subsection 7a74 7#c7 ,process ,any guidance issued by the ,secretary under paragraphs 7#a7 and 7#b7 shall be developed through a covered process4 7#d7 ,no conferring of rights or binding effect ,any guidance issued by the ,secretary under paragraphs 7#a7 and 7#b7 may not confer any rights on any person1 ,state1 or locality or bind the ,secretary or any person recommended in such guidance4 7c7 ,notification1 coordination1 and direct examination ,not later than #ahj days after the date of the enactment of this ,act1 the ,secretary shall establish a means1 using a covered process1 for the ,secretary to carry out the following3 7#a7 ,accept a notification provided by a covered entity under paragraph 7#e7 of subsection 7a74 7#b7 ,facilitate coordination with covered entities and stakeholders to identify a buyer1 prospective buyer1 or any combination thereof1 that has split orders across two or more covered entities with the purpose of obtaining or synthesizing a covered sequence4 7#c7 ,at the request of a covered entity1 provide direct examination to carry out the requirement under paragraph 7#f7 of such subsection4 7d7 ,identification of approaches1 best practices1 frameworks1 and methods 7#a7 ,in general ,not later than #a year after the date of the enactment of this ,act1 the ,secretary shall1 in consultation with the relevant heads of other ,federal departments1 agencies1 or offices1 as appropriate1 regularly consult with stakeholders1 including persons from academia and the private sector1 to identify the approaches1 best practices1 frameworks1 and methods under subsection 7b77#a77;,a71 including related to the following3 7,a7 ,improving the accuracy1 efficiency1 and reliability of any administrative and technical protocols required under subsection 7a71 including with respect to the independent assessment requirement under paragraph 7#f7 of such subsection4 7,b7 ,how a covered entity may offer an expedited review process to a previous buyer of such covered entity with respect to which the covered entity has carried out the requirements under paragraphs 7#a7 and 7#b7 of subsection 7a74 7,c7 ,how the ,secretary and any covered entity may identify nucleic acid sequences with a low potential for misuse4 7,d7 ,how the ,secretary and any covered entity may identify nucleic acid sequences1 including novel nucleic acid sequences1 that may be used in a manner that would pose a high risk to the national security of the ,united ,states or to the security and safety of persons in the ,united ,states4 7,e7 ,mitigate any risk related to misuse of benchtop nucleic acid synthesizers4 7#b7 ,report ,not later than #b years after the date of the enactment of this ,act1 and annually thereafter for #f years1 the ,secretary shall submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,commerce1 ,science1 and ,transportation of the ,senate a report-- 7,a7 developed through a covered process2 and 7,b7 that includes information related to any approaches1 best practices1 frameworks1 or methods identified under paragraph 7#a74 7e7 ,report and recommendations 7#a7 ,in general ,not later than #b years after the date of the enactment of this ,act1 and every #b years thereafter for #f years1 the ,secretary shall publish on a publicly available website a report that includes the following3 7,a7 ,an assessment on the following3 7i7 ,the economic competitiveness of the ,united ,states with respect to biotechnology1 including the manufacturing of nucleic acids4 7ii7 ,the ability of the ,secretary1 covered entities1 and any other relevant entity to mitigate any national security risk related to covered sequences manufactured and sold in interstate or foreign commerce4 7,b7 ,any legislative recommendation related to the following3 7i7 ,advancing such competitiveness4 7ii7 ,mitigating any such national security risk4 7#b7 ,public consultation ,in carrying out paragraph 7#a71 the ,secretary shall use a covered process4 7#c7 ,congressional notification ,prior to publishing a report under paragraph 7#a71 the ,secretary shall submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,commerce1 ,science1 and ,transportation of the ,senate such report4 7f7 ,covered sequence list 7#a7 ,in general ,not later than #ahj days after the date of the enactment of this ,act1 and regularly thereafter1 the ,secretary1 in consultation with the relevant heads of other ,federal departments1 agencies1 or offices1 as appropriate1 shall carry out the following3 7,a7 ,a determination of whether a nucleic acid sequence is a covered sequence4 7,b7 ,if the ,secretary makes a determination that a nucleic acid sequence is a covered sequence1 make available to covered entities a statement that explains the basis for such determination1 including any basis specified in paragraph 7#b71 as applicable4 7,c7 ,establish and make available to covered entities a list that includes any such covered sequence4 7,d7 ,establish a procedure to make any such statement and such list available to stakeholders in a manner that does not pose an unacceptable risk to the national security of the ,united ,states or the security and safety of ,united ,states persons4 7#b7 ,basis ,a determination under paragraph 7#a77;,a7 shall be based on one or more of the following3 7,a7 ,an assessment by the head of any other ,federal agency1 including a relevant national security agency or public health agency4 7,b7 ,a submission by a member of the public or a covered entity under paragraph 7#c77;,a74 7,c7 ,a determination by the ,secretary that a nucleic acid sequence poses an imminent or high likelihood of use in such a manner that it poses an unacceptable risk to the national security of the ,united ,states or the security and safety of ,united ,states persons4 7#c7 ,updates 7,a7 ,in general ,the ,secretary shall update1 as the ,secretary determines appropriate1 any list established and made available to covered entities under subparagraph 7,c7 of paragraph 7#a71 and any statement or list made available to stakeholders pursuant to the procedure established under subparagraph 7,d7 of such paragraph1 including in response to a novel nucleic acid sequence4 7,b7 ,submission process ,not later than #ahj days after the date of the enactment of this ,act1 the ,secretary shall1 through a covered process1 establish a process for the following3 7i7 ,a member of the public to submit to the ,secretary a recommendation related to adding a nucleic acid sequence to1 removing a covered sequence from1 or otherwise modifying any list established and made available to covered entities under subparagraph 7,c7 of paragraph 7#a71 and any statement or list made available to stakeholders pursuant to the procedure established under subparagraph 7,d7 of such paragraph4 7ii7 ,a covered entity to carry out the following3 7,i7 ,submit to the ,secretary a request for the ,secretary to review the inclusion of a covered sequence in any list established and made available to covered entities under subparagraph 7,c7 of paragraph 7#a71 and any statement or list made available to stakeholders pursuant to the procedure established under subparagraph 7,d7 of such paragraph1 to remove the covered sequence from1 or otherwise modify1 such list or statement4 7,,ii7 ,submit evidence to the ,secretary related to such request4 7,c7 ,confidentiality ,any information related to a recommendation1 request1 or evidence submitted pursuant to the process established under subparagraph 7,b7 shall be treated as a trade secret and commercial or financial information1 and shall be exempt from disclosure1 under section #eeb7;b77#d7 of title #e1 ,united ,states ,code4 7,d7 ,option to request nondisclosure ,in carrying out subparagraph 7,b71 the ,secretary shall offer any member of the public or covered entity that utilizes the process established under such subparagraph the ability to request that any information related to a recommendation1 request1 or evidence submitted pursuant to such process is not published or disclosed in any identifiable form1 including any publication or disclosure of any such information that would allow the identity of the member of the public or covered entity to be reasonably inferred4 7#d7 ,congressional notification ,with respect to any list established and made available to covered entities under subparagraph 7,c7 of paragraph 7#a71 and any statement or list made available to stakeholders pursuant to the procedure established under subparagraph 7,d7 of such paragraph1 the ,secretary shall-- 7,a7 at least #e days before establishing and making available such a list under such paragraph1 or adding a nucleic acid sequence to1 removing a covered sequence from1 or otherwise modifying such list1 submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,commerce1 ,science1 and ,transportation of the ,senate such list2 and 7,b7 provide to such committees a briefing related to such list1 upon request by such committees4 7g7 ,enforcement 7#a7 ,authority ,the ,secretary shall have the authority to carry out any of the following to enforce subsection 7a73 7,a7 ,require1 inspect1 and compel the provision of any physical and electronic records and any other information from such covered entity4 7,b7 ,administer oaths or affirmations and require any person to appear and testify or to appear and produce any such record or other information by subpoena4 7,c7 ,conduct investigations within the ,united ,states and outside the ,united ,states4 7#b7 ,civil actions 7,a7 ,in general ,the ,secretary may commence a civil action against a covered entity for a violation of subsection 7a7 in any district court of the ,united ,states for appropriate relief1 including-- 7i7 the penalty described under subparagraph 7,b72 or 7ii7 an injunction4 7,b7 ,penalty ,the penalty for a violation of subsection 7a7 may not exceed #gej1jjj per violation 7as adjusted on ,january #a each year by the percentage increase1 if applicable1 in the consumer price index for all urban consumers published by the ,bureau of ,labor ,statistics with respect to the #ab-month period preceding the date of such adjustment74 7,c7 ,right to cure 7i7 ,in general ,the ,secretary may initiate a civil action under subparagraph 7,a7 only if-- 7,i7 the ,secretary has provided to the relevant covered entity a written notice that describes the alleged violation and identifies the provision under subsection 7a7 related to such alleged violation2 and 7,,ii7 at least #cj days have passed since the date on which such written notice was so provided4 7ii7 ,effect of cure ,if a covered entity that receives a written notice under clause 7i77,i7 cures the alleged violation described in such notice not later than #cj days after the date on which such covered entity was provided such notice1 the ,secretary shall consider the requirements under subsection 7a7 as satisfied with respect to such covered entity4 7iii7 ,failure to cure ,after carrying out clause 7i71 the ,secretary may initiate an action under subparagraph 7,a7-- 7,i7 if the relevant covered entity fails to cure the alleged violation described in the written notice provided pursuant to clause 7i77,i72 or 7,,ii7 if1 after the curing the alleged violation as specified in clause 7ii71 the covered entity violates the relevant provision under subsection 7a7 again4 7#c7 ,relation to guidance ,the ,secretary may not commence a civil action under paragraph 7#b7 solely on the basis that a covered entity has carried out the requirements under subsection 7a7 in a manner that is inconsistent with any guidance issued under subsection 7b77#a74 7h7 ,relationship with other ,federal guidelines and recommendations ,the requirements in subsection 7a7 shall supersede any ,federal guideline or recommendation related to the screening of nucleic acid sequences made available in interstate or foreign commerce if such guideline or recommendation is voluntary and in effect before the date of the enactment of this ,act4 7i7 ,preemption 7#a7 ,in general ,no ,state or political subdivision of a ,state may prescribe1 maintain1 or enforce any law1 rule1 regulation1 requirement1 standard1 or other provision having the force and effect of law to the extent such law1 rule1 regulation1 requirement1 standard1 or other provision is covered by a requirement under subsection 7a74 7#b7 ,exception ,notwithstanding paragraph 7#a71 nothing in this ,act may be construed to preempt any law1 rule1 requirement1 or regulation of a ,state1 or political subdivision of a ,state1 with respect to any of the following3 7,a7 ,contract1 tort1 or product liability4 7,b7 ,consumer protection1 data privacy1 or data security4 7,c7 ,any such generally applicable law1 rule1 requirement1 or regulation of a ,state1 or a political subdivision of a ,state1 as it relates to public health4 7,d7 ,the procurement or use of nucleic acids or nucleic acid sequences by a ,state or a political subdivision of a ,state4 7j7 ,rule of construction ,nothing in this ,act may be construed to prohibit a covered entity from synthesizing a nucleic acid sequence or prohibit a covered entity from producing equipment for synthesizing a nucleic acid1 including a benchtop nucleic acid synthesizer4 7k7 ,effective date ,the requirement under subsection 7a7 shall take effect on the date that is #a year after the date of the enactment of this ,act4 7l7 ,definitions ,in this section3 7#a7 ,benchtop nucleic acid synthesizer ,the term benchtop nucleic acid synthesizer means a product1 device1 or integrated system in interstate or foreign commerce that is-- 7,a7 capable of generating de novo a nucleic acid sequence-- 7i7 at the direction of an end user of such product1 device1 or system2 or 7ii7 without requiring an end user of such product1 device1 or system to submit to another covered entity an order to perform the generation of such nucleic acid sequence2 and 7,b7 intended for distribution to1 or use by1 end users other than the developer of the product1 device1 or system1 regardless of the physical dimensions of such product1 device1 or system4 7#b7 ,covered entity 7,a7 ,in general ,the term covered entity means a person operating in interstate or foreign commerce who-- 7i7 synthesizes and sells nucleic acids to a person in the ,united ,states or in a foreign country2 or 7ii7 produces1 distributes1 sells1 or resells equipment for synthesizing nucleic acids1 including a benchtop nucleic acid synthesizer1 to persons in the ,united ,states or in a foreign country4 7,b7 ,exception ,subparagraph 7,a7 does not apply to the extent a person produces1 distributes1 sells1 or resells synthetic acids within a commercial entity solely for the internal use of such commercial entity4 7#c7 ,covered process ,the term covered process means1 with respect to the implementation of a requirement under this section1 a process by which the ,secretary-- 7,a7 publishes in the ,federal ,register a request for public feedback on the matters described in such provision2 7,b7 provides the public with an opportunity to comment on the matters described in subparagraph 7,a7 for a period of not less than #fj days2 7,c7 ensures that public comments made under subparagraph 7,b7 that are not marked confidential are available for public inspection2 and 7,d7 demonstrates consideration of any such public comments with respect to such implementation4 7#d7 ,secretary ,the term ,secretary means the ,secretary of ,commerce1 acting through the ,office of the ,secretary4