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 purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Improving Science in 

5 Chemical Assessments Act’’. 


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1 SEC. 2. RESEARCH NEEDS AND PRIORITIES OF EPA PRO2 GRAM OFFICES. 

3 The Environmental Research, Development, and 

4 Demonstration Authorization Act is amended by striking 

5 section 7 (42 U.S.C. 4364) and inserting the following: 

6 ‘‘SEC. 7. RESEARCH NEEDS AND PRIORITIES OF EPA PRO7 GRAM OFFICES. 

8 ‘‘(a) IN GENERAL.—The Administrator of the Envi9 ronmental Protection Agency shall assure that the expend10 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 pri14 orities of the relevant program offices, as well as the over15 all research needs and priorities of the Agency, including 

16 those defined in the five-year research plan. 

17 ‘‘(b) HAZARD IDENTIFICATION AND DOSE-RESPONSE

18 ASSESSMENTS.—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 Informa22 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 car25 ried out by the relevant program office of the Environ26 mental Protection Agency, so long as the relevant program 


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1 office determines there is a need for such an assessment. 

2 Such an assessment shall be carried out using the sci3 entific standards specified in section 7B and be based on 

4 the weight of the scientific evidence. 

5 ‘‘(c) TOXICITY VALUES.—In carrying out a covered 

6 assessment with respect to a chemical substance under 

7 subsection (a), 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 re10 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 de16 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) CHEMICAL ASSESSMENT DATABASE.— 

22 ‘‘(1) IN GENERAL.—A toxicity value or values 

23 assigned to a chemical substance under subsection 

24 (c) shall be included in a chemical assessment data25 base to be maintained by the Office of Research and 


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1 Development of the Environmental Protection Agen2 cy. 

3 ‘‘(2) COMPLETED ASSESSMENTS.—All covered 

4 assessments stored, as of the date of the enactment 

5 of this Act, in the IRIS database of the Environ6 mental Protection Agency shall be retained in the 

7 chemical assessment database established pursuant 

8 to paragraph (1). 

9 ‘‘(3) UPDATES.—Such database shall be up10 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) CERTIFICATION.—Beginning 2 years after the 

15 date of the enactment of the Improving Science in Chem16 ical Assessments Act and every 2 years thereafter, the Of17 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 by the report was conducted using the scientific standards 

25 specified in section 7B. 


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1 ‘‘(f) DEFINITIONS.—In this section, section 7A, and 

2 section 7B: 

3 ‘‘(1) The term ‘covered assessment’ means, with 

4 respect to the evaluation of the human health effects 

5 resulting from chronic exposure to a chemical sub6 stance, a chemical hazard identification and dose-re7 sponse assessment (as such terms are defined by the 

8 Environmental Protection Agency on the day before 

9 the date of the enactment of this Act). 

10 ‘‘(2) The term ‘relevant program office’ in11 cludes the following offices of the Environmental 

12 Protection Agency: 

13 ‘‘(A) The Office of Water. 

14 ‘‘(B) The Office of Air and Radiation. 

15 ‘‘(C) The Office of Land and Emergency 

16 Management. 

17 ‘‘(D) The Office of Chemical Safety and 

18 Pollution Prevention. 

19 ‘‘(E) Any successor to an office specified in 

20 subparagraphs (A) through (D) and any other 

21 office determined to be relevant by the Adminis22 trator of the Environmental Protection Agency. 


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1 ‘‘SEC. 7A. HAZARD IDENTIFICATION AND DOSE-RESPONSE 

2 STEERING COMMITTEE. 

3 ‘‘(a) ESTABLISHMENT.—Not later than 30 days after 

4 the date of the enactment of the Improving Science in 

5 Chemical Assessments Act, the Administrator of the Envi6 ronmental Protection Agency shall establish a chemical 

7 hazard identification and dose-response steering com8 mittee (referred to in this Act as the ‘steering committee’) 

9 to coordinate the conduct of covered assessments by rel10 evant program offices for purposes of ensuring that, with 

11 respect to such assessments, there is no duplication of ef12 fort by such offices. 

13 ‘‘(b) DUTY.—The duties of the steering committee 

14 are the following: 

15 ‘‘(1) If the steering committee learns that more 

16 than one relevant program office intends to conduct 

17 covered assessments with respect to the same chem18 ical substance, the steering committee shall deter19 mine the most effective means of carrying out a sin20 gle covered assessment to prevent duplication of ef21 fort by such offices. 

22 ‘‘(2) For purposes of supplementing a covered 

23 assessment, the steering committee shall consider 

24 any third-party assessment of a chemical substance 

25 generated by another Federal, State, or inter26 national agency or agencies or members of the sciVerDate Sep 11 2014 04:48 Jan 10, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H89.IH H89

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1 entific community that meets the requirements spec2 ified in subsection (e). 

3 ‘‘(c) CHAIR; COMPOSITION.— 

4 ‘‘(1) CHAIR.—The steering committee shall be 

5 chaired by the Assistant Administrator of the Office 

6 of Research and Development of the Environmental 

7 Protection Agency. 

8 ‘‘(2) COMPOSITION.—The steering committee 

9 shall be composed of 15 members, all of whom shall 

10 be active, full-time employees of the Environmental 

11 Protection Agency, with at least one member rep12 resenting each relevant program office and each re13 gional office of the Environmental Protection Agen14 cy. The members of the steering committee shall be 

15 appointed by the Administrator of the Environ16 mental Protection Agency. Any vacancy shall be 

17 filled in the same manner as the initial appointment. 

18 ‘‘(d) MEETINGS.—The steering committee shall meet 

19 at least once each calendar year. 

20 ‘‘(e) THIRD-PARTY ASSESSMENT REQUIREMENTS.— 

21 The requirements specified in this subsection with respect 

22 to a third-party assessment of a chemical substance are 

23 that the assessment— 

24 ‘‘(1) is conducted using scientific standards 

25 specified in section 7B; 


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1 ‘‘(2) has undergone independent scientific re2 view for transparency, completeness, and quality; 

3 and 

4 ‘‘(3) reflects the best available science and the 

5 weight of the available scientific evidence. 

6 ‘‘SEC. 7B. SCIENTIFIC STANDARDS. 

7 ‘‘Covered assessments carried out under section 7 

8 and discussion of such assessments and review of third9 party assessments carried out under section 7A, shall be 

10 conducted using scientific information, technical proce11 dures, measures, methods, protocols, methodologies, or 

12 models in a manner consistent with the best available 

13 science. In carrying out such an assessment, the relevant 

14 program office shall integrate all lines of scientific evi15 dence and consider, as applicable— 

16 ‘‘(1) the extent to which the scientific informa17 tion, technical procedures, measures, methods, proto18 cols, methodologies, or models employed to generate 

19 the scientific information are reasonable for and con20 sistent with the intended use of the scientific infor21 mation; 

22 ‘‘(2) the extent to which the scientific informa23 tion is relevant for the relevant program office’s use 

24 in making a decision about a chemical substance; 


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1 ‘‘(3) the degree of clarity and completeness with 

2 which the data, assumptions, methods, quality assur3 ance, analyses employed to generate the scientific in4 formation are documented and publicly available in 

5 a manner that honors legal and ethical obligations to 

6 reduce the risks of unauthorized disclosure and re7 identification; 

8 ‘‘(4) the extent to which the variability and un9 certainty in the scientific information, or in the pro10 cedures, measures, methods, protocols, methodolo11 gies, or models, are evaluated and characterized; 

12 ‘‘(5) the extent of independent verification or 

13 peer review of the scientific information or of the 

14 procedures, measures, methods, protocols, meth15 odologies, or models; 

16 ‘‘(6) the ability of the scientific findings and re17 search to be replicated or reproduced; and 

18 ‘‘(7) the extent to which the available scientific 

19 information supports dose-response modeling, using 

20 non-linear approaches.’’. 

Æ 


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