Improving Science in Chemical Assessments Act

I 116TH CONGRESS 1ST SESSION H. R. 89 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. IN THE HOUSE OF REPRESENTATIVES JANUARY 3, 2019 Mr. BIGGS introduced the following bill; which was referred to the Committee on Science, Space, and Technology, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL 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 pur- poses. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Improving Science in 4 Chemical Assessments Act’’. 5 VerDate Sep 11 2014 04:48 Jan 10, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H89.IH H89 kjohnson on DSK79L0C42 with BILLS 2 •HR 89 IH SEC. 2. RESEARCH NEEDS AND PRIORITIES OF EPA PRO- 1 GRAM OFFICES. 2 The Environmental Research, Development, and 3 Demonstration Authorization Act is amended by striking 4 section 7 (42 U.S.C. 4364) and inserting the following: 5 ‘‘SEC. 7. RESEARCH NEEDS AND PRIORITIES OF EPA PRO- 6 GRAM OFFICES. 7 ‘‘(a) IN GENERAL.—The Administrator of the Envi- 8 ronmental Protection Agency shall assure that the expend- 9 iture of any funds appropriated pursuant to this Act or 10 any other provision of law for environmental research and 11 development related to regulatory program activities shall 12 be coordinated with and reflect the research needs and pri- 13 orities of the relevant program offices, as well as the over- 14 all research needs and priorities of the Agency, including 15 those defined in the five-year research plan. 16 ‘‘(b) HAZARD IDENTIFICATION AND DOSE-RESPONSE 17 ASSESSMENTS.—Beginning on the date of the enactment 18 of the Improving Science in Chemical Assessments Act, 19 any covered assessments carried out with respect to a 20 chemical substance through the Integrated Risk Informa- 21 tion System program of the Environmental Protection 22 Agency as of the day before such date of enactment shall, 23 in lieu of being carried out through such program, be car- 24 ried out by the relevant program office of the Environ- 25 mental Protection Agency, so long as the relevant program 26 VerDate Sep 11 2014 04:48 Jan 10, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H89.IH H89 kjohnson on DSK79L0C42 with BILLS 3 •HR 89 IH office determines there is a need for such an assessment. 1 Such an assessment shall be carried out using the sci- 2 entific standards specified in section 7B and be based on 3 the weight of the scientific evidence. 4 ‘‘(c) TOXICITY VALUES.—In carrying out a covered 5 assessment with respect to a chemical substance under 6 subsection (a), the relevant program office shall assign a 7 toxicity value or values, when scientifically supported by 8 the available data, for such chemical substance. With re- 9 spect to that assignment, the following shall apply: 10 ‘‘(1) When supported by the available data, the 11 toxicity value or values shall include a range of point 12 estimates of risk as well as sources and magnitudes 13 of uncertainty associated with the estimates. 14 ‘‘(2) When multiple point estimates can be de- 15 veloped, the relevant program office shall— 16 ‘‘(A) consider all datasets; and 17 ‘‘(B) make a determination about how best 18 to represent the human health risk posed by the 19 chemical substance involved. 20 ‘‘(d) CHEMICAL ASSESSMENT DATABASE.— 21 ‘‘(1) IN GENERAL.—A toxicity value or values 22 assigned to a chemical substance under subsection 23 (c) shall be included in a chemical assessment data- 24 base to be maintained by the Office of Research and 25 VerDate Sep 11 2014 04:48 Jan 10, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H89.IH H89 kjohnson on DSK79L0C42 with BILLS 4 •HR 89 IH Development of the Environmental Protection Agen- 1 cy. 2 ‘‘(2) COMPLETED ASSESSMENTS.—All covered 3 assessments stored, as of the date of the enactment 4 of this Act, in the IRIS database of the Environ- 5 mental Protection Agency shall be retained in the 6 chemical assessment database established pursuant 7 to paragraph (1). 8 ‘‘(3) UPDATES.—Such database shall be up- 9 dated pursuant to a covered assessment performed 10 by a relevant program office, including to make a 11 change in the existing toxicity value or values for a 12 chemical substance included in such database. 13 ‘‘(e) CERTIFICATION.—Beginning 2 years after the 14 date of the enactment of the Improving Science in Chem- 15 ical Assessments Act and every 2 years thereafter, the Of- 16 fice of Research and Development of the Environmental 17 Protection Agency shall submit to the Committee on 18 Science, Space, and Technology and the Committee on 19 Energy and Commerce of the House of Representatives 20 and the Committee on Environment and Public Works of 21 the Senate, a report containing a certification that each 22 covered assessment completed during the period covered 23 by the report was conducted using the scientific standards 24 specified in section 7B. 25 VerDate Sep 11 2014 04:48 Jan 10, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H89.IH H89 kjohnson on DSK79L0C42 with BILLS 5 •HR 89 IH ‘‘(f) DEFINITIONS.—In this section, section 7A, and 1 section 7B: 2 ‘‘(1) The term ‘covered assessment’ means, with 3 respect to the evaluation of the human health effects 4 resulting from chronic exposure to a chemical sub- 5 stance, a chemical hazard identification and dose-re- 6 sponse assessment (as such terms are defined by the 7 Environmental Protection Agency on the day before 8 the date of the enactment of this Act). 9 ‘‘(2) The term ‘relevant program office’ in- 10 cludes the following offices of the Environmental 11 Protection Agency: 12 ‘‘(A) The Office of Water. 13 ‘‘(B) The Office of Air and Radiation. 14 ‘‘(C) The Office of Land and Emergency 15 Management. 16 ‘‘(D) The Office of Chemical Safety and 17 Pollution Prevention. 18 ‘‘(E) Any successor to an office specified in 19 subparagraphs (A) through (D) and any other 20 office determined to be relevant by the Adminis- 21 trator of the Environmental Protection Agency. 22 VerDate Sep 11 2014 04:48 Jan 10, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H89.IH H89 kjohnson on DSK79L0C42 with BILLS 6 •HR 89 IH ‘‘SEC. 7A. HAZARD IDENTIFICATION AND DOSE-RESPONSE 1 STEERING COMMITTEE. 2 ‘‘(a) ESTABLISHMENT.—Not later than 30 days after 3 the date of the enactment of the Improving Science in 4 Chemical Assessments Act, the Administrator of the Envi- 5 ronmental Protection Agency shall establish a chemical 6 hazard identification and dose-response steering com- 7 mittee (referred to in this Act as the ‘steering committee’) 8 to coordinate the conduct of covered assessments by rel- 9 evant program offices for purposes of ensuring that, with 10 respect to such assessments, there is no duplication of ef- 11 fort by such offices. 12 ‘‘(b) DUTY.—The duties of the steering committee 13 are the following: 14 ‘‘(1) If the steering committee learns that more 15 than one relevant program office intends to conduct 16 covered assessments with respect to the same chem- 17 ical substance, the steering committee shall deter- 18 mine the most effective means of carrying out a sin- 19 gle covered assessment to prevent duplication of ef- 20 fort by such offices. 21 ‘‘(2) For purposes of supplementing a covered 22 assessment, the steering committee shall consider 23 any third-party assessment of a chemical substance 24 generated by another Federal, State, or inter- 25 national agency or agencies or members of the sci- 26 VerDate Sep 11 2014 04:48 Jan 10, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H89.IH H89 kjohnson on DSK79L0C42 with BILLS 7 •HR 89 IH entific community that meets the requirements spec- 1 ified in subsection (e). 2 ‘‘(c) CHAIR; COMPOSITION.— 3 ‘‘(1) CHAIR.—The steering committee shall be 4 chaired by the Assistant Administrator of the Office 5 of Research and Development of the Environmental 6 Protection Agency. 7 ‘‘(2) COMPOSITION.—The steering committee 8 shall be composed of 15 members, all of whom shall 9 be active, full-time employees of the Environmental 10 Protection Agency, with at least one member rep- 11 resenting each relevant program office and each re- 12 gional office of the Environmental Protection Agen- 13 cy. The members of the steering committee shall be 14 appointed by the Administrator of the Environ- 15 mental Protection Agency. Any vacancy shall be 16 filled in the same manner as the initial appointment. 17 ‘‘(d) MEETINGS.—The steering committee shall meet 18 at least once each calendar year. 19 ‘‘(e) THIRD-PARTY ASSESSMENT REQUIREMENTS.— 20 The requirements specified in this subsection with respect 21 to a third-party assessment of a chemical substance are 22 that the assessment— 23 ‘‘(1) is conducted using scientific standards 24 specified in section 7B; 25 VerDate Sep 11 2014 04:48 Jan 10, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H89.IH H89 kjohnson on DSK79L0C42 with BILLS 8 •HR 89 IH ‘‘(2) has undergone independent scientific re- 1 view for transparency, completeness, and quality; 2 and 3 ‘‘(3) reflects the best available science and the 4 weight of the available scientific evidence. 5 ‘‘SEC. 7B. SCIENTIFIC STANDARDS. 6 ‘‘Covered assessments carried out under section 7 7 and discussion of such assessments and review of third- 8 party assessments carried out under section 7A, shall be 9 conducted using scientific information, technical proce- 10 dures, measures, methods, protocols, methodologies, or 11 models in a manner consistent with the best available 12 science. In carrying out such an assessment, the relevant 13 program office shall integrate all lines of scientific evi- 14 dence and consider, as applicable— 15 ‘‘(1) the extent to which the scientific informa- 16 tion, technical procedures, measures, methods, proto- 17 cols, methodologies, or models employed to generate 18 the scientific information are reasonable for and con- 19 sistent with the intended use of the scientific infor- 20 mation; 21 ‘‘(2) the extent to which the scientific informa- 22 tion is relevant for the relevant program office’s use 23 in making a decision about a chemical substance; 24 VerDate Sep 11 2014 04:48 Jan 10, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H89.IH H89 kjohnson on DSK79L0C42 with BILLS 9 •HR 89 IH ‘‘(3) the degree of clarity and completeness with 1 which the data, assumptions, methods, quality assur- 2 ance, analyses employed to generate the scientific in- 3 formation are documented and publicly available in 4 a manner that honors legal and ethical obligations to 5 reduce the risks of unauthorized disclosure and re- 6 identification; 7 ‘‘(4) the extent to which the variability and un- 8 certainty in the scientific information, or in the pro- 9 cedures, measures, methods, protocols, methodolo- 10 gies, or models, are evaluated and characterized; 11 ‘‘(5) the extent of independent verification or 12 peer review of the scientific information or of the 13 procedures, measures, methods, protocols, meth- 14 odologies, or models; 15 ‘‘(6) the ability of the scientific findings and re- 16 search to be replicated or reproduced; and 17 ‘‘(7) the extent to which the available scientific 18 information supports dose-response modeling, using 19 non-linear approaches.’’. 20 Æ VerDate Sep 11 2014 04:48 Jan 10, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6301 E:\BILLS\H89.IH H89 kjohnson on DSK79L0C42 with BILLS