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<dc:title>119 S4363 IS: Engineering Biology Readiness Act</dc:title>
<dc:publisher>U.S. Senate</dc:publisher>
<dc:date>2026-04-21</dc:date>
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<dc:language>EN</dc:language>
<dc:rights>Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.</dc:rights>
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<distribution-code display="yes">II</distribution-code><congress>119th CONGRESS</congress><session>2d Session</session><legis-num>S. 4363</legis-num><current-chamber>IN THE SENATE OF THE UNITED STATES</current-chamber><action><action-date date="20260421">April 21, 2026</action-date><action-desc><sponsor name-id="S362">Mr. Kaine</sponsor> (for himself and <cosponsor name-id="S417">Mr. Budd</cosponsor>) introduced the following bill; which was read twice and referred to the <committee-name committee-id="SSGA00">Committee on Homeland Security and Governmental Affairs</committee-name></action-desc></action><legis-type>A BILL</legis-type><official-title>To extend the requirement for annual briefings on National Biodefense Strategy and to require analysis and recommendations relating to the risks of engineering biology, and for other purposes.</official-title></form><legis-body><section id="idacb5b593f6354c0fbc18c426b7106a97" section-type="section-one"><enum>1.</enum><header>Short title</header><text display-inline="no-display-inline">This Act may be cited as the <quote><short-title>Engineering Biology Readiness Act</short-title></quote>.</text></section><section id="ide1c88c1a95be4128bf76062c79c14d4f"><enum>2.</enum><header>Extension of requirement for annual briefings on National Biodefense Strategy</header><text display-inline="no-display-inline">Section 1086(d) of the National Defense Authorization Act for Fiscal Year 2017 (<external-xref legal-doc="usc" parsable-cite="usc/6/104">6 U.S.C. 104(d)</external-xref>) is amended by striking <quote>March 1, 2025</quote> and inserting <quote>the date that is five years after the date of the enactment of the National Defense Authorization Act for Fiscal Year 2027</quote>.</text></section><section id="id558e6efde0004c1abfbb4a03b0a6203f"><enum>3.</enum><header>Analysis and recommendations relating to engineering biology risks</header><subsection id="id43527191fc73481697908fd37ec69b2d"><enum>(a)</enum><header>In general</header><text>The first time after the date of the enactment of this Act that findings are provided to the appropriate congressional committees pursuant to the biennial update of the biodefense threat assessment under section 364(d)(1)(D) of the William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 (<external-xref legal-doc="usc" parsable-cite="usc/6/106">6 U.S.C. 106(d)(1)(D)</external-xref>), such findings shall include an analysis of, and recommendations to enhance, the readiness of the United States national security enterprise and life science research enterprise against engineering biology risks.</text></subsection><subsection id="id0e47a98f21e54d71a1be6414be1da531"><enum>(b)</enum><header>Matters included</header><paragraph id="id41a817c36fed4683ab9a5dbe20c9a372"><enum>(1)</enum><header>Analysis</header><text>The analysis required by subsection (a) shall include the following:</text><subparagraph id="idffe540f82bdd42318eb6d10c29030869"><enum>(A)</enum><text>An assessment of the threat to national security and public safety posed by current and anticipated engineering biology risks.</text></subparagraph><subparagraph id="id2a3c11a36a11419ab00aedb24a8027dc"><enum>(B)</enum><text>A description of current lines of research and development in covered departments and agencies relating to biodefense against engineering biology risks, including prevention, deterrence, preparedness, detection, response, attribution, recovery, and mitigation.</text></subparagraph><subparagraph id="id6725b38d4734459fb8dfb3a01fd80697"><enum>(C)</enum><text>An analysis of authorities, regulations, and programs pertaining to engineering biology risks, in the United States, including biosafety, biosecurity, and biodefense.</text></subparagraph><subparagraph id="id6f9405cfaa8d401083dce56c12dd0de7"><enum>(D)</enum><text>An evaluation of gaps, deficiencies, redundancies, and ambiguities in authorities and regulations pertaining to engineering biology risks.</text></subparagraph><subparagraph id="idd39aab35bc0443d6aebffb8cf832454e"><enum>(E)</enum><text>Such other matters as the heads of the covered departments and agencies jointly consider relevant.</text></subparagraph></paragraph><paragraph id="id6b4e5671188643208d5a3e47428b4c31"><enum>(2)</enum><header>Recommendations</header><text>The recommendations required by subsection (a) shall include recommendations for the following:</text><subparagraph id="iddf650e0b3eac49228e09b91f65bb732d"><enum>(A)</enum><text>Aligning lines of research and development across covered departments and agencies to reduce redundant efforts and promote the mutual benefit for purposes of biosafety, biosecurity, and biodefense against engineering biology risks.</text></subparagraph><subparagraph id="idf957df6be3bc4fc6a5de63eb34aea702"><enum>(B)</enum><text>Modernizing biosafety, biosecurity, and biodefense authorities, regulations, and programs pertaining to engineering biology risks to ensure the United States—</text><clause id="id3472cc0d5d0d4addbc37f87a7fcacc14"><enum>(i)</enum><text>mitigates the safety and security threat to national security and public safety posed by engineering biology risks; and</text></clause><clause id="id40a41ae950de421da1c9318d2ee6724f"><enum>(ii)</enum><text>benefits from the research, development, application, and dissemination of innovations in engineering biology under an enduring governance framework that accommodates novel discoveries and capabilities in life sciences research;</text></clause></subparagraph><subparagraph id="id5d6323f105044b83b37737da8f900591"><enum>(C)</enum><text>Establishing a program or programs, or modernizing an existing program or programs—</text><clause id="id49b77bbefb2942cbaca826f5d706fd2b"><enum>(i)</enum><text>to establish and enforce safeguards to mitigate engineering biology risks to national security or public safety; and</text></clause><clause id="id70db5c69f2214ac0a6a17829566ab1f0"><enum>(ii)</enum><text>to identify best practices, promulgate voluntary guidance, and provide consultation on matters of biosecurity and biosafety in the United States.</text></clause></subparagraph><subparagraph id="id217b33696983451fb0da31f2d2483f29"><enum>(D)</enum><text>For purposes of subparagraphs (B) and (C), detailed proposed legislative action and an estimate of the amount of funding necessary to ensure that relevant programs have adequate resources.</text></subparagraph><subparagraph id="id7998e383df2e4a928a4aefd24ea231fd"><enum>(E)</enum><text>Such other matters as the heads of the covered departments and agencies jointly consider relevant.</text></subparagraph></paragraph></subsection><subsection id="id82d42671ad1f4fbfbc53f1402ad1e27b"><enum>(c)</enum><header>Consultation</header><text>The recommendations described in subsection (b)(2) shall be developed in consultation with—</text><paragraph id="id4fe5a18570f948699abc36ac690bca6c"><enum>(1)</enum><text>individuals representing industry, academia, and civil society, including representatives of the life sciences research enterprise who have not received any Federal grant or contract in the preceding five years; and</text></paragraph><paragraph id="ide11d2bc53b1a41cea4ce48b0e14177cc"><enum>(2)</enum><text>such other government agencies or interested stakeholders as the heads of the covered departments and agencies jointly consider appropriate.</text></paragraph></subsection><subsection id="ide4f1f22ed7814e83a165db6c1e86e854"><enum>(d)</enum><header>Form</header><text>The analysis and recommendations required by this section shall be submitted in unclassified form but may include a classified annex.</text></subsection><subsection id="idbc34a55f37f9420b813e5799e800eae8"><enum>(e)</enum><header>Definitions</header><text>In this section:</text><paragraph id="id8d52d1c890e44d8c93bdb924a5f08ff2"><enum>(1)</enum><text>The term <term>covered departments and agencies</term> means the departments and agencies included in section 364(a) of the William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 (<external-xref legal-doc="usc" parsable-cite="usc/6/106">6 U.S.C. 106(a)</external-xref>).</text></paragraph><paragraph id="idb4882b4318654212a1629d371832e8b9"><enum>(2)</enum><text>The term <term>engineering biology</term> has the meaning given such term in section 10002 of the Research and Development, Competition, and Innovation Act (<external-xref legal-doc="usc" parsable-cite="usc/42/18901">42 U.S.C. 18901</external-xref>).</text></paragraph><paragraph id="idbc55971a3aef4a3ba89333c947f8ee2f"><enum>(3)</enum><text>The term <term>engineering biology risk</term> means a risk to national security or public safety arising from the misuse, abuse, or accidental release of materials arising from, or the misuse or abuse of methods, tools, or information pertaining to, engineering biology.</text></paragraph></subsection></section></legis-body></bill>

