I 119THCONGRESS 1 STSESSION H. R. 123 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 JANUARY3, 2025 Mr. B IGGSof Arizona 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 de- termined 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 05:56 Jan 29, 2025 Jkt 059200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H123.IH H123 kjohnson on DSK7ZCZBW3PROD with $$_JOB 2 •HR 123 IH SEC. 2. RESEARCH NEEDS AND PRIORITIES OF EPA PRO-1 GRAM OFFICES. 2 The Environmental Research, Development, and 3 Demonstration Authorization Act of 1978 is amended by 4 striking section 7 (42 U.S.C. 4364) and inserting the fol-5 lowing new sections: 6 ‘‘SEC. 7. RESEARCH NEEDS AND PRIORITIES OF EPA PRO-7 GRAM OFFICES. 8 ‘‘(a) I NGENERAL.—The Administrator of the Envi-9 ronmental Protection Agency shall assure that the expend-10 iture of any funds appropriated pursuant to this Act or 11 any other provision of law for environmental research and 12 development related to regulatory program activities shall 13 be coordinated with and reflect the research needs and pri-14 orities of the relevant program offices, as well as the over-15 all research needs and priorities of the Agency, including 16 those defined in the five-year research plan. 17 ‘‘(b) H AZARDIDENTIFICATION ANDDOSE-RESPONSE 18 A SSESSMENTS.—Beginning on the date of the enactment 19 of the Improving Science in Chemical Assessments Act, 20 any covered assessments carried out with respect to a 21 chemical substance through the Integrated Risk Informa-22 tion System program of the Environmental Protection 23 Agency as of the day before such date of enactment shall, 24 in lieu of being carried out through such program, be car-25 ried out by the relevant program office of the Environ-26 VerDate Sep 11 2014 05:56 Jan 29, 2025 Jkt 059200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H123.IH H123 kjohnson on DSK7ZCZBW3PROD with $$_JOB 3 •HR 123 IH mental Protection Agency, so long as the relevant program 1 office determines there is a need for such an assessment. 2 Such an assessment shall be carried out using the sci-3 entific standards specified in section 7B and be based on 4 the weight of the scientific evidence. 5 ‘‘(c) T OXICITYVALUES.—In carrying out a covered 6 assessment with respect to a chemical substance under 7 subsection (b), the relevant program office shall assign a 8 toxicity value or values, when scientifically supported by 9 the available data, for such chemical substance. With re-10 spect to that assignment, the following shall apply: 11 ‘‘(1) When supported by the available data, the 12 toxicity value or values shall include a range of point 13 estimates of risk, as well as sources and magnitudes 14 of uncertainty associated with the estimates. 15 ‘‘(2) When multiple point estimates can be de-16 veloped, the relevant program office shall— 17 ‘‘(A) consider all datasets; and 18 ‘‘(B) make a determination about how best 19 to represent the human health risk posed by the 20 chemical substance involved. 21 ‘‘(d) C HEMICALASSESSMENTDATABASE.— 22 ‘‘(1) I N GENERAL.—A toxicity value or values 23 assigned to a chemical substance under subsection 24 (c) shall be included in a chemical assessment data-25 VerDate Sep 11 2014 05:56 Jan 29, 2025 Jkt 059200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H123.IH H123 kjohnson on DSK7ZCZBW3PROD with $$_JOB 4 •HR 123 IH base to be maintained by the Office of Research and 1 Development of the Environmental Protection Agen-2 cy. 3 ‘‘(2) C OMPLETED ASSESSMENTS .—All covered 4 assessments stored, as of the date of the enactment 5 of this Act, in the IRIS database of the Environ-6 mental Protection Agency shall be retained in the 7 chemical assessment database established pursuant 8 to paragraph (1). 9 ‘‘(3) U PDATES.—Such database shall be up-10 dated pursuant to a covered assessment performed 11 by a relevant program office, including to make a 12 change in the existing toxicity value or values for a 13 chemical substance included in such database. 14 ‘‘(e) C ERTIFICATION.—Beginning 2 years after the 15 date of the enactment of the Improving Science in Chem-16 ical Assessments Act and every 2 years thereafter, the Of-17 fice of Research and Development of the Environmental 18 Protection Agency shall submit to the Committee on 19 Science, Space, and Technology and the Committee on 20 Energy and Commerce of the House of Representatives 21 and the Committee on Environment and Public Works of 22 the Senate a report containing a certification that each 23 covered assessment completed during the period covered 24 VerDate Sep 11 2014 05:56 Jan 29, 2025 Jkt 059200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H123.IH H123 kjohnson on DSK7ZCZBW3PROD with $$_JOB 5 •HR 123 IH by the report was conducted using the scientific standards 1 specified in section 7B. 2 ‘‘(f) D EFINITIONS.—In this section, section 7A, and 3 section 7B: 4 ‘‘(1) C OVERED ASSESSMENT .—The term ‘cov-5 ered assessment’ means, with respect to the evalua-6 tion of the human health effects resulting from 7 chronic exposure to a chemical substance, a chemical 8 hazard identification and dose-response assessment 9 (as such terms are defined by the Environmental 10 Protection Agency on the day before the date of the 11 enactment of this section). 12 ‘‘(2) R ELEVANT PROGRAM OFFICE .—The term 13 ‘relevant program office’ includes the following of-14 fices of the Environmental Protection Agency: 15 ‘‘(A) The Office of Water. 16 ‘‘(B) The Office of Air and Radiation. 17 ‘‘(C) The Office of Land and Emergency 18 Management. 19 ‘‘(D) The Office of Chemical Safety and 20 Pollution Prevention. 21 ‘‘(E) Any successor to an office specified in 22 subparagraphs (A) through (D) and any other 23 office determined to be relevant by the Adminis-24 trator of the Environmental Protection Agency. 25 VerDate Sep 11 2014 05:56 Jan 29, 2025 Jkt 059200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H123.IH H123 kjohnson on DSK7ZCZBW3PROD with $$_JOB 6 •HR 123 IH ‘‘SEC. 7A. HAZARD IDENTIFICATION AND DOSE-RESPONSE 1 STEERING COMMITTEE. 2 ‘‘(a) E STABLISHMENT.—Not later than 30 days after 3 the date of the enactment of the Improving Science in 4 Chemical Assessments Act, the Administrator of the Envi-5 ronmental Protection Agency shall establish a chemical 6 hazard identification and dose-response steering com-7 mittee (referred to in this section as the ‘steering com-8 mittee’) to coordinate the conduct of covered assessments 9 by relevant program offices for purposes of ensuring that, 10 with respect to such assessments, there is no duplication 11 of effort by such offices. 12 ‘‘(b) D UTY.—The duties of the steering committee 13 are the following: 14 ‘‘(1) If the steering committee learns that more 15 than one relevant program office intends to conduct 16 covered assessments with respect to the same chem-17 ical substance, the steering committee shall deter-18 mine the most effective means of carrying out a sin-19 gle covered assessment to prevent duplication of ef-20 fort by such offices. 21 ‘‘(2) For purposes of supplementing a covered 22 assessment, the steering committee shall consider 23 any third-party assessment of a chemical substance 24 generated by another Federal, State, or inter-25 national agency or agencies or members of the sci-26 VerDate Sep 11 2014 05:56 Jan 29, 2025 Jkt 059200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H123.IH H123 kjohnson on DSK7ZCZBW3PROD with $$_JOB 7 •HR 123 IH entific community that meets the requirements spec-1 ified in subsection (e). 2 ‘‘(c) C HAIR; COMPOSITION.— 3 ‘‘(1) C HAIR.—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) C OMPOSITION.—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) M EETINGS.—The steering committee shall meet 18 at least once each calendar year. 19 ‘‘(e) T HIRD-PARTYASSESSMENTREQUIREMENTS.— 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 05:56 Jan 29, 2025 Jkt 059200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H123.IH H123 kjohnson on DSK7ZCZBW3PROD with $$_JOB 8 •HR 123 IH ‘‘(2) has undergone independent scientific re-1 view for transparency, completeness, and quality; 2 and 3 ‘‘(3) reflects the best available science and the 4 weight of the available scientific evidence. 5 ‘‘SEC. 7B. SCIENTIFIC STANDARDS. 6 ‘‘Covered assessments carried out under section 7 7 and discussion of such assessments and review of third- 8 party assessments carried out under section 7A shall be 9 conducted using scientific information, technical proce-10 dures, measures, methods, protocols, methodologies, or 11 models in a manner consistent with the best available 12 science. In carrying out such an assessment, the relevant 13 program office shall integrate all lines of scientific evi-14 dence and consider, as applicable, the following: 15 ‘‘(1) The extent to which the scientific informa-16 tion, technical procedures, measures, methods, proto-17 cols, methodologies, or models employed to generate 18 the scientific information are reasonable for and con-19 sistent with the intended use of the scientific infor-20 mation. 21 ‘‘(2) The extent to which the scientific informa-22 tion is relevant for the relevant program office’s use 23 in making a decision regarding a chemical sub-24 stance. 25 VerDate Sep 11 2014 05:56 Jan 29, 2025 Jkt 059200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H123.IH H123 kjohnson on DSK7ZCZBW3PROD with $$_JOB 9 •HR 123 IH ‘‘(3) The degree of clarity and completeness 1 with which the data, assumptions, methods, quality 2 assurance, and analyses employed to generate the 3 scientific information are documented and publicly 4 available in a manner that honors legal and ethical 5 obligations to reduce the risks of unauthorized dis-6 closure and re-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 16 research to be replicated or reproduced. 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 05:56 Jan 29, 2025 Jkt 059200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6301 E:\BILLS\H123.IH H123 kjohnson on DSK7ZCZBW3PROD with $$_JOB