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<bill bill-stage="Introduced-in-Senate" public-private="public">
	<form>
		<distribution-code display="yes">II</distribution-code>
		<congress>111th CONGRESS</congress>
		<session>1st Session</session>
		<legis-num>S. 485</legis-num>
		<current-chamber>IN THE SENATE OF THE UNITED STATES</current-chamber>
		<action>
			<action-date date="20090226">February 26, 2009</action-date>
			<action-desc><sponsor name-id="S300">Mr. Burr</sponsor> (for himself
			 and <cosponsor name-id="S055">Mr. Kennedy</cosponsor>) introduced the following
			 bill; which was read twice and referred to the
			 <committee-name committee-id="SSHR00">Committee on Health, Education, Labor,
			 and Pensions</committee-name></action-desc>
		</action>
		<legis-type>A BILL</legis-type>
		<official-title>To reauthorize the Select Agent Program by amending the
		  Public Health Service Act and the Agricultural Bioterrorism Protection Act of
		  2002 and to improve oversight of high containment
		  laboratories.</official-title>
	</form>
	<legis-body>
		<section id="S1" section-type="section-one"><enum>1.</enum><header>Short
			 title; table of contents</header>
			<subsection id="idFE9848B3577A414585BFA0521FB90375"><enum>(a)</enum><header>Short
			 title</header><text display-inline="yes-display-inline">This Act may be cited
			 as the <quote><short-title>Select Agent Program and
			 Biosafety Improvement Act of 2009</short-title></quote>.</text>
			</subsection><subsection id="id82958D7737444D4DBE3BD04EC7D27D9B"><enum>(b)</enum><header>Table of
			 contents</header><text>The table of contents for this Act is as follows:</text>
				<toc>
					<toc-entry idref="S1" level="section">Sec. 1. Short title; table of
				contents.</toc-entry>
					<toc-entry idref="id550A54C0627A41B3966C227153E6F828" level="section">Sec. 2. Findings.</toc-entry>
					<toc-entry idref="idBB7F19DBD4CF401EB66CC3E1EDEBF8C6" level="title">TITLE I—Select agent program reauthorization</toc-entry>
					<toc-entry idref="id8F0687A11BDE4ED7986EA9970AD8DB36" level="section">Sec. 101. Reauthorization of select agent program.</toc-entry>
					<toc-entry idref="id6111E2EB5D184CBA84BC4752C5E982A8" level="section">Sec. 102. Select agent program review.</toc-entry>
					<toc-entry idref="idFC0077BC23B34CADB4C07A031D7770C1" level="section">Sec. 103. Revision of the list of biological agents and
				toxins.</toc-entry>
					<toc-entry idref="id8AF407C4FB0448C692271FAD87AC96B5" level="section">Sec. 104. Sharing information with trusted State
				partners.</toc-entry>
					<toc-entry idref="id606F89031B3E41A88C532BFFAC34A26B" level="section">Sec. 105. Improvements to inventorying and monitoring of
				agents.</toc-entry>
					<toc-entry idref="id0FCD8C81568340DE9A971CEA09D24726" level="section">Sec. 106. Smallpox definition clarification.</toc-entry>
					<toc-entry idref="idC8F471E33DB94E3DB7DF542EE53E564B" level="section">Sec. 107. Plan for surge in samples of biological agents and
				toxins.</toc-entry>
					<toc-entry idref="id9D120EBBA37E45EC9E86EFA1B58A41E3" level="title">TITLE II—Biosafety improvements</toc-entry>
					<toc-entry idref="id5188CA6049ED47699DFD88517B2E222A" level="section">Sec. 201. Improvement of oversight of biocontainment
				laboratories.</toc-entry>
					<toc-entry idref="id0D9D22EF18184D1E9221F1690EE39566" level="section">Sec. 202. Improvement of training for laboratory
				personnel.</toc-entry>
					<toc-entry idref="id5359F666CEC349CEA8C5F5DDF78BAE4C" level="section">Sec. 203. Biological laboratory incident reporting
				system.</toc-entry>
				</toc>
			</subsection></section><section id="id550A54C0627A41B3966C227153E6F828"><enum>2.</enum><header>Findings</header><text display-inline="no-display-inline">Congress finds the following:</text>
			<paragraph id="ID863f1e6f3be4420d9a23597bbabc717f"><enum>(1)</enum><text>The Centers for
			 Disease Control and Prevention regulates the possession, use, and transfer of
			 select agents and toxins that have the potential to pose a severe threat to
			 public health and safety.</text>
			</paragraph><paragraph id="ID59179f304547465a92af90d2e0420827"><enum>(2)</enum><text>The Animal and
			 Plant Health Inspection Service regulates the possession, use, and transfer of
			 select agents and toxins that have the potential to pose a severe threat to
			 animal or plant health, or to animal or plant products.</text>
			</paragraph><paragraph id="IDad9cf0befec84edfbc1f6810330a2d2f"><enum>(3)</enum><text>As of February
			 2009, there are 82 select agents and toxins, 13 of which are found naturally in
			 the United States.</text>
			</paragraph><paragraph id="IDb4ba8872873743bb8261f35c65159d2a"><enum>(4)</enum><text>As of February
			 2009, there are 336 entities registered with the Centers for Disease Control
			 and Prevention to work with select agents and toxins and 64 entities registered
			 with the Animal and Plant Health Inspection Service. There are 10,463
			 individuals approved to work with select agents and toxins through the Centers
			 for Disease Control and Prevention and 4,149 through the Animal and Plant
			 Health Inspection Service.</text>
			</paragraph><paragraph id="ID2f56ea6fd1d446aaa06d1c0f775503a3"><enum>(5)</enum><text>Biocontainment
			 laboratories are used by scientists to study infectious materials safely and
			 effectively. Laboratory biological research is categorized by the safety level
			 at which it is performed. There are 4 safety levels, termed Biosafety Level
			 (BSL) 1 through 4.</text>
			</paragraph></section><title id="idBB7F19DBD4CF401EB66CC3E1EDEBF8C6"><enum>I</enum><header>Select agent
			 program reauthorization</header>
			<section id="id8F0687A11BDE4ED7986EA9970AD8DB36"><enum>101.</enum><header>Reauthorization
			 of select agent program</header>
				<subsection id="id2EFCDE664C1C410F80F9B75D51A588DC"><enum>(a)</enum><header>Reauthorization
			 of select agent program</header>
					<paragraph id="id1D9FC0321234436FB14100C4FD472594"><enum>(1)</enum><header>Amendment to
			 the Public Health Service Act</header><text>Section 351A(m) of the Public
			 Health Service Act (42 U.S.C. 262a(m)) is amended by striking <quote>2002
			 through 2007</quote> and inserting <quote>2010 through 2014</quote>.</text>
					</paragraph><paragraph id="id7BCF1EB071904AF0A2862C3CD1D29039"><enum>(2)</enum><header>Amendment to
			 the Agricultural Bioterrorism Protection Act of 2002</header><text>Section
			 212(m) of the Agricultural Bioterrorism Protection Act of 2002 (7 U.S.C.
			 8401(m)) is amended by striking <quote>2002 through 2007</quote> and inserting
			 <quote>2010 through 2014</quote>.</text>
					</paragraph></subsection><subsection commented="no" id="IDc22b0c3b120543a293027bc70ddb3e4d"><enum>(b)</enum><header>Appropriate
			 training</header>
					<paragraph commented="no" id="id3CC576F4D77942F9994BAEC8A7B8D2EF"><enum>(1)</enum><header>Amendment to
			 the Public Health Service Act</header><text>Section 351A(e)(2)(A) of the Public
			 Health Service Act (42 U.S.C. 262a(e)(2)(A)) is amended by inserting <quote>,
			 and appropriate training,</quote> after <quote>have a legitimate
			 need</quote>.</text>
					</paragraph><paragraph commented="no" id="id6179A81DEBFA4CFBBC782CA21F870CFA"><enum>(2)</enum><header>Amendment to
			 the Agricultural Bioterrorism Protection Act of 2002</header><text>Section
			 212(e)(2)(A) of the Agricultural Bioterrorism Protection Act of 2002 (7 U.S.C.
			 8401(e)(2)(A)) is amended by inserting <quote>, and appropriate
			 training,</quote> after <quote>have a legitimate need</quote>.</text>
					</paragraph></subsection><subsection commented="no" id="ID2d7bfae021c34fb68eef498d08203782"><enum>(c)</enum><header>Covered
			 agencies</header>
					<paragraph commented="no" id="id44F45FEEC5AC4ED094313220FE490F1D"><enum>(1)</enum><header>Amendment to
			 the Public Health Service Act</header><text>Section 351A(h)(2)(A) (42 U.S.C.
			 262a(h)(2)(A)) of the Public Health Service Act is amended by inserting
			 <quote>the Department of Homeland Security,</quote> after <quote>the Department
			 of Agriculture,</quote>.</text>
					</paragraph><paragraph commented="no" id="id6BA4AB8706CA4DBFA4C7110EF01AA017"><enum>(2)</enum><header>Amendment to
			 the Agricultural Bioterrorism Protection Act of 2002</header><text>Section
			 212(h)(2)(A) of the Agricultural Bioterrorism Protection Act of 2002 (7 U.S.C.
			 8401(h)(2)(A)) is amended by inserting <quote>the Department of Homeland
			 Security,</quote> after <quote>the Department of Agriculture,</quote>.</text>
					</paragraph></subsection></section><section id="id6111E2EB5D184CBA84BC4752C5E982A8"><enum>102.</enum><header>Select agent
			 program review</header>
				<subsection id="ID4ea3d6e616f54e21bc6693f92fd6ca34"><enum>(a)</enum><header>In
			 general</header><text>The Secretary of Health and Human Services, in
			 consultation with the Secretary of Agriculture, shall enter into a contract
			 with the National Academy of Sciences to conduct a review of the select agent
			 program under section 351A of the Public Health Service Act (42 U.S.C. 262a)
			 and section 212 of the Agricultural Bioterrorism Protection Act of 2002 (7
			 U.S.C. 8401). Such review shall focus on—</text>
					<paragraph id="ID613cc16a9ec443e9ab1f454270237a10"><enum>(1)</enum><text>the extent to
			 which the program has enhanced biosecurity and biosafety in the United
			 States;</text>
					</paragraph><paragraph id="ID7ec31069403c4c65905e0efd13180017"><enum>(2)</enum><text>the effects of
			 the program on—</text>
						<subparagraph id="ID8f859efa6191453eb189fa2680fedac8"><enum>(A)</enum><text>international
			 scientific collaboration; and</text>
						</subparagraph><subparagraph id="ID585b5ce6dcf040318a8ff4d7c4d04365"><enum>(B)</enum><text>scientific
			 advances in the United States; and</text>
						</subparagraph></paragraph><paragraph id="id377CC36658A0476EB30FB7987D6742B5"><enum>(3)</enum><text>other issues as
			 requested by the Secretary of Health and Human Services and the Secretary of
			 Agriculture.</text>
					</paragraph></subsection><subsection id="ID84193150eff34812a80e637dd811634c"><enum>(b)</enum><header>Report;
			 recommendations</header><text>Not later than 240 days after the date of
			 enactment of this Act, the National Academy of Sciences shall submit a report
			 to the Secretary of Health and Human Services, the Secretary of Agriculture,
			 the Committee on Health, Education, Labor, and Pensions of the Senate, the
			 Committee on Energy and Commerce of the House of Representatives, and other
			 congressional committees of relevant interest, on the results of the review
			 conducted under subsection (a). Such report shall include recommendations for
			 improving the structure of the select agent program for—</text>
					<paragraph id="ID19bdc4f3a6c24c9b95b27f53129e84be"><enum>(1)</enum><text>enhancing the
			 biosecurity and biosafety of the United States;</text>
					</paragraph><paragraph id="ID3358163384654370afcec328a0a72fba"><enum>(2)</enum><text>eliminating or
			 reducing adverse effects of the program, if any, on—</text>
						<subparagraph id="ID63d11ce5fdfb43a0a48c2c63aa9aad78"><enum>(A)</enum><text>international
			 scientific collaboration; and</text>
						</subparagraph><subparagraph id="ID2e05a16d633242c6b3f4c93a8a63d677"><enum>(B)</enum><text>scientific
			 advances in the United States; and</text>
						</subparagraph></paragraph><paragraph id="idEED1B8D36CB54EFD88C775BA08704A17"><enum>(3)</enum><text>other issues as
			 requested by the Secretary of Health and Human Services and the Secretary of
			 Agriculture.</text>
					</paragraph></subsection></section><section id="idFC0077BC23B34CADB4C07A031D7770C1"><enum>103.</enum><header>Revision of
			 the list of biological agents and toxins</header>
				<subsection id="idF0E7F3CE30B0486BB8B3D354371F3DB8"><enum>(a)</enum><header>Amendment to
			 the Public Health Service Act</header><text>Section 351A(a)(1)(B)(i) of the
			 Public Health Service Act (42 U.S.C. 262a(a)(1)(B)(i)) is amended—</text>
					<paragraph id="id9DC07C75489F4061BE4866057592583C"><enum>(1)</enum><text>in subclause
			 (III), by striking <quote>; and</quote> and inserting a semicolon;</text>
					</paragraph><paragraph id="idA1403D95FD7F408DB42AF2A17559F8A7"><enum>(2)</enum><text>by redesignating
			 subclause (IV) as subclause (VII); and</text>
					</paragraph><paragraph id="idC566E9FAA03E4C86A8C70A6EAAA4BE30"><enum>(3)</enum><text>by inserting
			 after subclause (III) the following:</text>
						<quoted-block display-inline="no-display-inline" id="id4307F2B4E34844B7AB88C4CEAA4696B9" style="OLC">
							<subclause id="idBAC93627875D4293B8E3F3FEA8EE3DE4"><enum>(IV)</enum><text>whether the
				agent or toxin is endemic to the United States, as defined by the
				Secretary;</text>
							</subclause><subclause id="id74054B6A1E3D4979A4F8389CBB09C284"><enum>(V)</enum><text>information
				available from biological risk assessments conducted by the Department of
				Homeland Security;</text>
							</subclause><subclause id="idCFD57A39E0EE42D79BCEE79C7C7D9159"><enum>(VI)</enum><text>newly discovered
				agents of disease, including genetically modified organisms or agents created
				synthetically;
				and</text>
							</subclause><after-quoted-block>.</after-quoted-block></quoted-block>
					</paragraph></subsection><subsection id="id0CC4A3FBADF0476FA9F07A894D1AA0A7"><enum>(b)</enum><header>Amendment to
			 the Agricultural Bioterrorism Protection Act of 2002</header><text>Section
			 212(a)(1)(B)(i) of the Agricultural Bioterrorism Protection Act of 2002 (7
			 U.S.C. 8401(a)(1)(B)(i)) is amended—</text>
					<paragraph id="id5B4A3EEFD41F449996A688395802094E"><enum>(1)</enum><text>in subclause
			 (III), by striking <quote>; and</quote> and inserting a semicolon;</text>
					</paragraph><paragraph id="id61EF3BA12E1840E78F4E07BA8EF97F20"><enum>(2)</enum><text>by redesignating
			 subclause (IV) as subclause (VII); and</text>
					</paragraph><paragraph id="id699E8830A488472BB312240384BC487A"><enum>(3)</enum><text>by inserting
			 after subclause (III) the following:</text>
						<quoted-block display-inline="no-display-inline" id="idD6A343AD1EAE4E79BE538C00939807A3" style="OLC">
							<subclause id="id338EE6462E5C4D0EB4397B2579C87AA3"><enum>(IV)</enum><text>whether the
				agent or toxin is endemic to the United States, as defined by the
				Secretary;</text>
							</subclause><subclause id="id4071CEDE2E2942AB9F84C22923441C2A"><enum>(V)</enum><text>information
				available from biological risk assessments conducted by the Department of
				Homeland Security;</text>
							</subclause><subclause commented="no" display-inline="no-display-inline" id="id5842C023DE784FB499FABFD44426CD6F"><enum>(VI)</enum><text>newly discovered
				agents of disease, including genetically modified organisms or agents created
				synthetically;
				and</text>
							</subclause><after-quoted-block>.</after-quoted-block></quoted-block>
					</paragraph></subsection><subsection id="ID58eba52bb4f94158885ce60526370656"><enum>(c)</enum><header>Rule of
			 construction</header><text>The amendments made by subsections (a) and (b) shall
			 not be construed to preclude the listing of a biological agent or toxin that is
			 endemic to the United States.</text>
				</subsection></section><section id="id8AF407C4FB0448C692271FAD87AC96B5"><enum>104.</enum><header>Sharing
			 information with trusted State partners</header>
				<subsection id="id7EE101F6C3A249D3B8C16EA041ED5E6C"><enum>(a)</enum><header>Amendment to
			 the Public Health Service Act</header><text>Section 351A(h)(5) of the Public
			 Health Service Act (42 U.S.C. 262a(h)(5)) is amended—</text>
					<paragraph id="id80E5EE4ACD4948B4B2CA3576F3B3ABAE"><enum>(1)</enum><text>in subparagraph
			 (A), by striking <quote>; or</quote> and inserting a semicolon;</text>
					</paragraph><paragraph id="idDC90E20445544B96A8448FAD78AADDEA"><enum>(2)</enum><text>in subparagraph
			 (B), by striking the period and inserting <quote>; or</quote>; and</text>
					</paragraph><paragraph id="id0E417D905CDB43E09CE948785EA75D73"><enum>(3)</enum><text>by inserting at
			 the end the following:</text>
						<quoted-block display-inline="no-display-inline" id="id2AA80A048F004DA59A665A37A14E8FB9" style="OLC">
							<subparagraph id="id44C6D5530D934C93ABD62EC4DAAA487F"><enum>(C)</enum><text>to withhold
				information regarding a State that will assist with the State's emergency
				preparedness planning from the health director (or equivalent State official)
				of such State, if such State has in place a law to protect against the further
				release of such information as determined by the
				Secretary.</text>
							</subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
					</paragraph></subsection><subsection id="idA1F499DE4F2F412794BF607C01C0945F"><enum>(b)</enum><header>Amendment to
			 the Agricultural Bioterrorism Protection Act of 2002</header><text>Section
			 212(h)(5) of the Agricultural Bioterrorism Protection Act of 2002 (7 U.S.C.
			 8401(h)(5)) is amended—</text>
					<paragraph id="id7FBE81A001B54472A37A45250C6AF77D"><enum>(1)</enum><text>in subparagraph
			 (A), by striking <quote>; or</quote> and inserting a semicolon;</text>
					</paragraph><paragraph id="id6C64A0EB545C447DAC97A9E21225F657"><enum>(2)</enum><text>in subparagraph
			 (B), by striking the period and inserting <quote>; or</quote>; and</text>
					</paragraph><paragraph id="id631B4E08FC334E908CA49C0FEDCE685A"><enum>(3)</enum><text>by inserting at
			 the end the following:</text>
						<quoted-block display-inline="no-display-inline" id="idA936EFDC4BEC4AB8A65CC9166A953DE6" style="OLC">
							<subparagraph id="idF979EB8C4FC64464B80EC0DE7423BF10"><enum>(C)</enum><text>to withhold
				information regarding a State that will assist with the State's emergency
				preparedness planning from an elected or appointed senior State agricultural
				official or equivalent State official (such as a State veterinarian or a State
				plant health regulatory official) of such State, if such State has in place a
				law to protect against the further release of such information as determined by
				the
				Secretary.</text>
							</subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
					</paragraph></subsection></section><section id="id606F89031B3E41A88C532BFFAC34A26B"><enum>105.</enum><header>Improvements
			 to inventorying and monitoring of agents</header>
				<subsection id="id5135A6210E974EE5A5A4DF597BD59053"><enum>(a)</enum><header>Improved method
			 to inventory and monitor listed biological agents</header><text display-inline="yes-display-inline">Not later than 180 days after enactment of
			 this Act, the Secretary of Health and Human Services, in coordination with the
			 Secretary of Agriculture, and in consultation with individuals with appropriate
			 scientific expertise, shall issue guidance on inventorying and monitoring the
			 biological agents listed under section 351A(a)(1) of the Public Health Service
			 Act (42 U.S.C. 262a(a)(1)) and the biological agents listed under section
			 212(a)(1) of the Agricultural Bioterrorism Protection Act of 2002 (7 U.S.C.
			 8401(a)(1)).</text>
				</subsection><subsection id="id834E2077893D4F32BED1CF293CC4D547"><enum>(b)</enum><header>Considerations</header><text display-inline="yes-display-inline">In issuing the guidance under subsection
			 (a), the Secretaries shall consider—</text>
					<paragraph id="ID7276df4e80fc4584b9bca43c07ed0b04"><enum>(1)</enum><text>the effectiveness
			 of measures to inventory and monitor listed biological agents that can
			 propagate relative to the burden of these measures on laboratory
			 personnel;</text>
					</paragraph><paragraph id="idF86E32A1886141F8BBF876CC5A4E83BE"><enum>(2)</enum><text display-inline="yes-display-inline">qualitative and quantitative control
			 procedures for such listed agents, rather than only quantitative control
			 procedures; and</text>
					</paragraph><paragraph id="ID3f65453db3aa4ed58e223e31485e7ab9"><enum>(3)</enum><text>in what
			 situations registered persons are required to keep inventory records.</text>
					</paragraph></subsection></section><section id="id0FCD8C81568340DE9A971CEA09D24726"><enum>106.</enum><header>Smallpox
			 definition clarification</header><text display-inline="no-display-inline">Not
			 later than 90 days after the date of enactment of this Act, the Attorney
			 General, in coordination with the Secretary of Health and Human Services, shall
			 issue public guidance regarding how the Attorney General interprets the scope
			 of the statutory definition of <quote>variola virus</quote> in section 175c of
			 title 18, United States Code.</text>
			</section><section id="idC8F471E33DB94E3DB7DF542EE53E564B"><enum>107.</enum><header>Plan for surge
			 in samples of biological agents and toxins</header><text display-inline="no-display-inline">The Secretary of Health and Human Services,
			 in coordination with the Secretary of Agriculture and State officials, shall
			 develop and disseminate guidelines for how laboratories and laboratory
			 personnel that do not regularly test for listed agents and toxins (as such
			 terms are defined in section 351A of the Public Health Service Act (42 U.S.C.
			 262a) and section 212 of the Agricultural Bioterrorism Protection Act of 2002
			 (7 U.S.C. 8401)) may be rapidly accessed and utilized during emergencies in
			 which laboratories and laboratory personnel that regularly test for such agents
			 and toxins are overwhelmed by a surge of samples of such listed agents and
			 toxins.</text>
			</section></title><title id="id9D120EBBA37E45EC9E86EFA1B58A41E3"><enum>II</enum><header>Biosafety
			 improvements</header>
			<section id="id5188CA6049ED47699DFD88517B2E222A"><enum>201.</enum><header>Improvement of
			 oversight of biocontainment laboratories</header>
				<subsection id="id66B1DF58C7E247FDBA02120B5757363F"><enum>(a)</enum><header>Definition</header><text>For
			 purposes of this section, the term <term>high containment biological
			 laboratory</term> means a laboratory that has Biosafety Level 3 or Biosafety
			 Level 4 facilities, as defined by the Secretary of Health and Human Services
			 and the Secretary of Agriculture.</text>
				</subsection><subsection id="IDeac8badd62ed441dab4960730e99b027"><enum>(b)</enum><header>Evaluation</header><text>The
			 Secretary of Health and Human Services, in coordination with the Secretary of
			 Agriculture, and in consultation with the Secretary of Defense and the
			 Secretary of Homeland Security (referred to in this section as the
			 <quote>Secretaries</quote>) shall, either directly or through a contract,
			 evaluate national needs of, and oversight of, high containment biological
			 laboratories.</text>
				</subsection><subsection id="IDd9ddb4c050f64b37beb6efdeda42b51d"><enum>(c)</enum><header>Considerations</header><text>In
			 conducting the evaluation under subsection (b), the Secretaries shall
			 consider—</text>
					<paragraph id="ID9dda51c1da3f43659643ac40352b26a9"><enum>(1)</enum><text>whether the
			 construction of high containment biological laboratories that are in existence
			 or planned as of the date of enactment of this Act, is likely to provide
			 sufficient capacity for the needs of Government biodefense and infectious
			 disease research;</text>
					</paragraph><paragraph id="ID280c354d2b6341c68f2fb59b50ba5a97"><enum>(2)</enum><text>how laboratory
			 capacity and lessons learned can be best shared across the biodefense and
			 infectious disease research communities, domestically and
			 internationally;</text>
					</paragraph><paragraph id="ID779c6c6d26574c19afa761c4854063ed"><enum>(3)</enum><text>whether guidance
			 on laboratory infrastructure, commissioning, operation, and maintenance of such
			 laboratories is adequate, and if such guidance is found to be inadequate, how
			 to improve and streamline such guidance; and</text>
					</paragraph><paragraph id="ID280cbdeb36c2449aa6ab49eb9d337693"><enum>(4)</enum><text>ways to improve
			 and streamline the training of the personnel of such laboratories, including
			 recommendations regarding the minimum standards for laboratory biosafety and
			 biosecurity training under section 202.</text>
					</paragraph></subsection><subsection id="IDa6ee6003d37f498a883353a59603121b"><enum>(d)</enum><header>Report to
			 congress</header><text>Not later than 240 days after the date of enactment of
			 this Act, the Secretary of Health and Human Services shall submit to Congress a
			 report on the findings and recommendations from the evaluation under this
			 section.</text>
				</subsection></section><section commented="no" display-inline="no-display-inline" id="id0D9D22EF18184D1E9221F1690EE39566"><enum>202.</enum><header>Improvement of
			 training for laboratory personnel</header>
				<subsection id="id6D32D819F3154EB1A8F18A55181BBC96"><enum>(a)</enum><header>Definition</header><text>For
			 purposes of this section, the term <term>high containment biological
			 laboratory</term> means a laboratory that has Biosafety Level 3 or Biosafety
			 Level 4 facilities, as defined by the Secretary of Health and Human Services
			 and the Secretary of Agriculture.</text>
				</subsection><subsection id="IDe68b1ec9f98f47e98f0d522831cfed03"><enum>(b)</enum><header>Development of
			 minimum standards</header><text>The Secretary of Health and Human Services,
			 acting through the Director of the Centers for Disease Control and Prevention
			 and the Director of the National Institutes of Health, and in coordination with
			 the Secretary of Agriculture and scientific experts representing appropriate
			 professional groups and international health organizations, shall develop
			 minimum standards for laboratory biosafety and biosecurity training for
			 relevant personnel of high containment biological laboratories. In developing
			 such standards, the Secretary of Health and Human Services shall consider
			 existing laboratory guidelines and training modules.</text>
				</subsection><subsection id="IDd59896fc73dd4c01971c80c42407b3fd"><enum>(c)</enum><header>Requirement for
			 approval</header><text>A person may not register with the Secretary of Health
			 and Human Services or the Secretary of Agriculture for the possession, use, or
			 transfer of listed agents in accordance with section 351A of the Public Health
			 Service Act (42 U.S.C. 262a) and section 212 of the Agricultural Bioterrorism
			 Protection Act of 2002 (7 U.S.C. 8401) unless the person provides to its
			 appropriate personnel biosafety and biosecurity training that meets the minimum
			 standards under subsection (b) in addition to any other requirements determined
			 appropriate by the Secretary of Health and Human Services or the Secretary of
			 Agriculture.</text>
				</subsection><subsection id="ID2fe5db15c60f4ffbbf61e53deb66fa2f"><enum>(d)</enum><header>Dissemination</header><text>The
			 Secretary of Health and Human Services, in coordination with the Secretary of
			 Agriculture, may disseminate the minimum standards under subsection (b) for
			 voluntary use, such as when use is not required under subsection (b), in
			 laboratories and academic programs in the United States and in other
			 countries.</text>
				</subsection></section><section id="id5359F666CEC349CEA8C5F5DDF78BAE4C"><enum>203.</enum><header>Biological
			 laboratory incident reporting system</header>
				<subsection id="ID05caf02cbd324fe6887a07d355882827"><enum>(a)</enum><header>In
			 general</header><text>The Secretary of Health and Human Services, in
			 coordination with the Secretary of Agriculture (referred to in this section as
			 the <quote>Secretaries</quote>), shall establish an integrated Biological
			 Laboratory Incident Reporting System through which personnel of biological
			 laboratories may voluntarily report biosafety or biosecurity incidents of
			 concern and the Secretaries may identify trends in such incidents and protocols
			 for biosafety or biosecurity improvements. In developing such reporting system,
			 the Secretaries shall consider options for integrating existing voluntary and
			 required reporting mechanisms.</text>
				</subsection><subsection id="IDd3610bed939f475c8fb9bcec61f5ae6a"><enum>(b)</enum><header>Functions</header><text>In
			 implementing the reporting system under subsection (a), the Secretaries shall
			 enter into a contract with a public or private entity that does not regulate
			 biological laboratories to administer the reporting system. Such entity
			 shall—</text>
					<paragraph id="ID3b2197e5994249898f5f88e15f08d34e"><enum>(1)</enum><text>receive and
			 process incident reports;</text>
					</paragraph><paragraph id="ID3d229eb3d48f4573bc7f733519a6702e"><enum>(2)</enum><text>analyze,
			 interpret incident data, and identify incident trends;</text>
					</paragraph><paragraph id="ID3185369537cf4366aaded0fe5b961acd"><enum>(3)</enum><text>issue alert
			 messages within an appropriate time period;</text>
					</paragraph><paragraph id="ID129a35d425a0468d90e3120f686c66e2"><enum>(4)</enum><text>disseminate
			 reports and other appropriate information, which shall not include
			 facility-specific information;</text>
					</paragraph><paragraph id="ID388f3e7911a54f83a55cec72e375090b"><enum>(5)</enum><text>not have
			 authority to direct corrective action or to initiate enforcement action;</text>
					</paragraph><paragraph id="IDecf24b9514ac450bb3a5da40638154c0"><enum>(6)</enum><text>ensure anonymity
			 of individuals reporting to the system, to the extent permitted by law;
			 and</text>
					</paragraph><paragraph id="IDf60b7603b06c421f9a394bb84525783e"><enum>(7)</enum><text>conduct other
			 activities as requested by the Secretaries.</text>
					</paragraph></subsection></section></title></legis-body>
</bill>
