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<bill bill-stage="Introduced-in-House" bill-type="olc" dms-id="H60BD7F2F0E9A4FE39F7E7FF1F96FBC70" key="H" public-private="public"><metadata xmlns:dc="http://purl.org/dc/elements/1.1/">
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<dc:title>115 HR 6399 IH: Chemical Assessment Improvement Act</dc:title>
<dc:publisher>U.S. House of Representatives</dc:publisher>
<dc:date>2018-07-17</dc:date>
<dc:format>text/xml</dc:format>
<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">I</distribution-code><congress display="yes">115th CONGRESS</congress><session display="yes">2d Session</session><legis-num display="yes">H. R. 6399</legis-num><current-chamber>IN THE HOUSE OF REPRESENTATIVES</current-chamber><action display="yes"><action-date date="20180717">July 17, 2018</action-date><action-desc><sponsor name-id="B001302">Mr. Biggs</sponsor> (for himself, <cosponsor name-id="S000583">Mr. Smith of Texas</cosponsor>, <cosponsor name-id="L000491">Mr. Lucas</cosponsor>, <cosponsor name-id="N000190">Mr. Norman</cosponsor>, <cosponsor name-id="R000409">Mr. Rohrabacher</cosponsor>, <cosponsor name-id="P000599">Mr. Posey</cosponsor>, <cosponsor name-id="W000814">Mr. Weber of Texas</cosponsor>, <cosponsor name-id="B001291">Mr. Babin</cosponsor>, <cosponsor name-id="H001077">Mr. Higgins of Louisiana</cosponsor>, <cosponsor name-id="L000589">Mrs. Lesko</cosponsor>, <cosponsor name-id="H001059">Mr. Hultgren</cosponsor>, <cosponsor name-id="A000374">Mr. Abraham</cosponsor>, <cosponsor name-id="W000806">Mr. Webster of Florida</cosponsor>, <cosponsor name-id="M001198">Mr. Marshall</cosponsor>, <cosponsor name-id="D000628">Mr. Dunn</cosponsor>, <cosponsor name-id="W000821">Mr. Westerman</cosponsor>, and <cosponsor name-id="M001194">Mr. Moolenaar</cosponsor>) introduced the following bill; which was referred to the <committee-name committee-id="HIF00">Committee on Energy and Commerce</committee-name></action-desc></action><legis-type>A BILL</legis-type><official-title display="yes">To direct that certain assessments with respect to toxicity of chemicals be carried out by the
			 program offices of the Environmental Protection Agency, and for other
			 purposes.</official-title></form>
	<legis-body id="H712559C7BC694F05866ECFA2DB9DCC93" style="OLC">
 <section id="HA6AD1B91F70344888BD9E1711B79B86E" 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>Chemical Assessment Improvement Act</short-title></quote>.</text> </section><section id="HC84BFDD91E6E4A68951A19FDF5D2D844"><enum>2.</enum><header>Hazard Identification and Dose Response Assessments</header> <subsection id="H089A4B3543F94497A46B2A4DFB66332A"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Beginning on the date of the enactment of this Act, any covered assessments carried out with respect to a chemical substance through the Integrated Risk Information System program of the Environmental Protection Agency as of the day before such date of enactment shall, in lieu of being carried out through such program, be carried out by the relevant program office of the Environmental Protection Agency, so long as the relevant program office determines there is a need for such an assessment. Such an assessment shall be carried out using scientific standards specified in section 4 and be based on the weight of the scientific evidence.</text>
 </subsection><subsection id="HA5FA893EF6B640C99E2EA337D3A2A056"><enum>(b)</enum><header>Toxicity values</header><text display-inline="yes-display-inline">In carrying out such an assessment with respect to a chemical substance under subsection (a), the relevant program office shall assign a toxicity value or values, when scientifically supported by the available data, for such chemical substance. With respect to that assignment, the following shall apply:</text>
 <paragraph id="H6770E2E2AAF644DC9733AA0EAE12BDDE"><enum>(1)</enum><text display-inline="yes-display-inline">When supported by the available data, the toxicity value or values shall include a range of point estimates of risk as well as sources and magnitudes of uncertainty associated with the estimates.</text>
 </paragraph><paragraph id="H25F9B17AB72B46D4A8C17C27527CE01E"><enum>(2)</enum><text>When multiple point estimates can be developed, the relevant program office shall—</text> <subparagraph id="HF4011E6C8DEE4C34973E7218E7BCBAE7"><enum>(A)</enum><text>consider all datasets; and</text>
 </subparagraph><subparagraph id="H3BFC06C832FF4293A3B0C3270715D14F"><enum>(B)</enum><text>make a determination about how best to represent the human health risk posed by the chemical substance involved.</text>
					</subparagraph></paragraph></subsection><subsection id="HD49C750A93DC429ABC407F98E1BF94D7"><enum>(c)</enum><header>Chemical assessment database</header>
 <paragraph id="H899753CBF6A0442EB0EA8CDC071DDF2D"><enum>(1)</enum><header>In general</header><text>A toxicity value or values assigned to a chemical substance under subsection (b) shall be included in a chemical assessment database to be maintained by the Office of Research and Development of the Environmental Protection Agency.</text>
 </paragraph><paragraph id="H4AE87EFBCA314B448291822211BCDFA5"><enum>(2)</enum><header>Completed assessments</header><text>All covered assessments stored, as of the date of the enactment of this Act, in the IRIS database of the Environmental Protection Agency shall be retained in the chemical assessment database established pursuant to paragraph (1).</text>
 </paragraph><paragraph id="HBC4B33870A74444EAB3C64F02051664B"><enum>(3)</enum><header>Updates</header><text display-inline="yes-display-inline">Such database shall be updated pursuant to a covered assessment performed by a relevant program office, including to make a change in the existing toxicity value or values for a chemical substance included in such database.</text>
 </paragraph></subsection><subsection id="H724BC5B4AFEF4722A5FB4E21C882FBED"><enum>(d)</enum><header>Definitions</header><text>In this section:</text> <paragraph id="H8D7F4450302246A285FA583BE03EE971"><enum>(1)</enum><text display-inline="yes-display-inline">The term <term>covered assessment</term> means, with respect to the evaluation of the human health effects resulting from chronic exposure to a chemical substance, a chemical hazard identification and dose response assessment (as such terms are defined by the Environmental Protection Agency on the day before the date of the enactment of this Act).</text>
 </paragraph><paragraph id="HBC39AA39E37A4A07B77EADC788C1CC08"><enum>(2)</enum><text>The term <term>relevant program office</term> includes the following offices of the Environmental Protection Agency:</text> <subparagraph id="H8D2C69A94AF64EA7AAF2A8ECCDDBC431"><enum>(A)</enum><text>The Office of Water.</text>
 </subparagraph><subparagraph id="H5A29EC4BDE394A81907F891F79B1A20A"><enum>(B)</enum><text>The Office of Air and Radiation.</text> </subparagraph><subparagraph id="H0B4F332F7F444536B635CED432B937C1"><enum>(C)</enum><text>The Office of Land and Emergency Management.</text>
 </subparagraph><subparagraph id="H6AFBE86D9C9641E4BDC7D05B8104C8FB"><enum>(D)</enum><text>The Office of Chemical Safety and Pollution Prevention.</text> </subparagraph><subparagraph id="HC7B4F25CB5EC4706AAD9BA0492E838C4"><enum>(E)</enum><text>Any successor to an office specified in subparagraphs (A) through (D) and any other office determined to be relevant by the Administrator of the Environmental Protection Agency.</text>
					</subparagraph></paragraph></subsection></section><section id="HBE28975A44414D868E0D46838DA7C16D"><enum>3.</enum><header>Hazard Identification and Dose Response Steering Committee</header>
 <subsection id="H53928E0F72D0432F99F19ABFEF97446A"><enum>(a)</enum><header>Establishment</header><text display-inline="yes-display-inline">Not later than 30 days after the date of the enactment of this Act, the Administrator of the Environmental Protection Agency (referred to in this Act as the <quote>Administrator</quote>) shall establish a chemical hazard identification and dose response steering committee (referred to in this Act as the <quote>steering committee</quote>) to coordinate the conduct of covered assessments by relevant program offices for purposes of ensuring that, with respect to such assessments, there is no duplication of effort by such offices. <italic></italic></text>
 </subsection><subsection id="H22CEC055EE0F4C2AA112A6DE4A8BE93A"><enum>(b)</enum><header>Duty</header><text>The duties of the steering committee are the following:</text> <paragraph id="H768CCA200442492C85805F4B49AB95DC"><enum>(1)</enum><text>If the steering committee learns that more than one relevant program office intends to conduct covered assessments with respect to the same chemical substance, the steering committee shall determine the most effective means of carrying out a single covered assessment to prevent duplication of effort by such offices.</text>
 </paragraph><paragraph id="H3622F7E71EA04F988D956823A69EBEF0"><enum>(2)</enum><text display-inline="yes-display-inline">For purposes of supplementing a covered assessment, the steering committee shall consider any third-party assessment of a chemical substance generated by another Federal, State, or international agency or agencies or members of the scientific community that meets the requirements specified in subsection (e).</text>
				</paragraph></subsection><subsection id="H6E0BCAE9405B4CD58C3A705C9003BED2"><enum>(c)</enum><header>Chair; composition</header>
 <paragraph id="H4AF5C386060A48AB9B484AD0C62386EB"><enum>(1)</enum><header>Chair</header><text>The steering committee shall be chaired by the Assistant Administrator of the Office of Research and Development of the Environmental Protection Agency.</text>
 </paragraph><paragraph id="HA59E90A90D5D4E11BCBBE1B7D7E2E8CF"><enum>(2)</enum><header>Composition</header><text>The steering committee shall be composed of 15 members, all of whom shall be active, full-time employees of the Environmental Protection Agency, with at least one member representing each relevant program office and each regional office of the Environmental Protection Agency. The members of the steering committee shall be appointed by the Administrator of the Environmental Protection Agency. Any vacancy shall be filled in the same manner as the initial appointment.<italic></italic></text>
 </paragraph></subsection><subsection id="H0F993010207C4E42A7EE67003E4F5995"><enum>(d)</enum><header>Meetings</header><text>The steering committee shall meet at least once each calendar year.</text> </subsection><subsection id="HDB079B1301454E7C89BBE7AF3C5C5DCE"><enum>(e)</enum><header>Third-Party assessment requirements</header><text display-inline="yes-display-inline">The requirements specified in this subsection with respect to a third-party assessment of a chemical substance are that the assessment—</text>
 <paragraph id="H0ABA3EF757E142DAACDFB235AF9CC8F9"><enum>(1)</enum><text display-inline="yes-display-inline">is conducted using scientific standards specified in section 4;</text> </paragraph><paragraph id="H3F116ABB6E044BE6AF1672277E7AE6A5"><enum>(2)</enum><text>has undergone independent scientific review for transparency, completeness, and quality; and</text>
 </paragraph><paragraph id="HF7E09488F46A4018994A3DE31BE12884"><enum>(3)</enum><text>reflects the best available science and the weight of the available scientific evidence.</text> </paragraph></subsection></section><section id="H8CD16EE5D36B4858AE4855BCE0563464"><enum>4.</enum><header>Scientific standards</header> <text display-inline="no-display-inline"><italic></italic> Covered assessments carried out under section 2 and discussion of such assessments and review of third-party assessments carried out under section 3, shall be conducted using scientific information, technical procedures, measures, methods, protocols, methodologies, or models in a manner consistent with the best available science. In carrying out such an assessment, the relevant program office shall integrate all lines of scientific evidence and consider, as applicable—</text>
 <paragraph id="HB51538B466F84E7ABE186123B8F07B7D"><enum>(1)</enum><text>the extent to which the scientific information, technical procedures, measures, methods, protocols, methodologies, or models employed to generate the scientific information are reasonable for and consistent with the intended use of the scientific information;</text>
 </paragraph><paragraph id="H396A3C4691C94CF09B0DF017827FF292"><enum>(2)</enum><text>the extent to which the scientific information is relevant for the relevant program office’s use in making a decision about a chemical substance;</text>
 </paragraph><paragraph id="H8954E1B30F6349729C4E0D4AA4F4CE24"><enum>(3)</enum><text>the degree of clarity and completeness with which the data, assumptions, methods, quality assurance, analyses employed to generate the scientific information are documented and publicly available in a manner that honors legal and ethical obligations to reduce the risks of unauthorized disclosure and re-identification;</text>
 </paragraph><paragraph id="HE10659DA27A64B5EAE4C3A215C1561D4"><enum>(4)</enum><text>the extent to which the variability and uncertainty in the scientific information, or in the procedures, measures, methods, protocols, methodologies, or models, are evaluated and characterized;</text>
 </paragraph><paragraph id="H54A77232ED954623AB0BCCF46D73EA24"><enum>(5)</enum><text>the extent of independent verification or peer review of the scientific information or of the procedures, measures, methods, protocols, methodologies, or models;</text>
 </paragraph><paragraph id="HFFF7FE1A89E84FC8A994C4DA70F6180A"><enum>(6)</enum><text>the ability of the scientific findings and research to be replicated or reproduced; and</text> </paragraph><paragraph id="H03A784E8D34D4E69B64F77EC75D9AA79"><enum>(7)</enum><text>the extent to which the available scientific information supports dose-response modeling, using non-linear approaches.</text>
			</paragraph></section></legis-body></bill>


