Title: Improving Science in Chemical Assessments Act
Policy area: Environmental Protection

Summary:
Improving Science in Chemical Assessments Act
This bill modifies procedures related to specified chemical assessments performed by the Environmental Protection Agency (EPA). Specifically, chemical hazard identification and dose response assessments, currently performed by the Integrated Risk Information System program, must be performed by the appropriate EPA program office.
Additionally, the bill requires the EPA to establish a steering committee to ensure there is no duplication of effort by relevant program offices in conducting covered assessments.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 89 Introduced in House (IH)]

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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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Improving Science in Chemical 
Assessments Act''.

SEC. 2. RESEARCH NEEDS AND PRIORITIES OF EPA PROGRAM OFFICES.

    The Environmental Research, Development, and Demonstration 
Authorization Act is amended by striking section 7 (42 U.S.C. 4364) and 
inserting the following:

``SEC. 7. RESEARCH NEEDS AND PRIORITIES OF EPA PROGRAM OFFICES.

    ``(a) In General.--The Administrator of the Environmental 
Protection Agency shall assure that the expenditure of any funds 
appropriated pursuant to this Act or any other provision of law for 
environmental research and development related to regulatory program 
activities shall be coordinated with and reflect the research needs and 
priorities of the relevant program offices, as well as the overall 
research needs and priorities of the Agency, including those defined in 
the five-year research plan.
    ``(b) Hazard Identification and Dose-Response Assessments.--
Beginning on the date of the enactment of the Improving Science in 
Chemical Assessments 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 the scientific standards 
specified in section 7B and be based on the weight of the scientific 
evidence.
    ``(c) Toxicity Values.--In carrying out a covered 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:
            ``(1) 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.
            ``(2) When multiple point estimates can be developed, the 
        relevant program office shall--
                    ``(A) consider all datasets; and
                    ``(B) make a determination about how best to 
                represent the human health risk posed by the chemical 
                substance involved.
    ``(d) Chemical Assessment Database.--
            ``(1) In general.--A toxicity value or values assigned to a 
        chemical substance under subsection (c) shall be included in a 
        chemical assessment database to be maintained by the Office of 
        Research and Development of the Environmental Protection 
        Agency.
            ``(2) Completed assessments.--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).
            ``(3) Updates.--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.
    ``(e) Certification.--Beginning 2 years after the date of the 
enactment of the Improving Science in Chemical Assessments Act and 
every 2 years thereafter, the Office of Research and Development of the 
Environmental Protection Agency shall submit to the Committee on 
Science, Space, and Technology and the Committee on Energy and Commerce 
of the House of Representatives and the Committee on Environment and 
Public Works of the Senate, a report containing a certification that 
each covered assessment completed during the period covered by the 
report was conducted using the scientific standards specified in 
section 7B.
    ``(f) Definitions.--In this section, section 7A, and section 7B:
            ``(1) The term `covered assessment' 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).
            ``(2) The term `relevant program office' includes the 
        following offices of the Environmental Protection Agency:
                    ``(A) The Office of Water.
                    ``(B) The Office of Air and Radiation.
                    ``(C) The Office of Land and Emergency Management.
                    ``(D) The Office of Chemical Safety and Pollution 
                Prevention.
                    ``(E) 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.

``SEC. 7A. HAZARD IDENTIFICATION AND DOSE-RESPONSE STEERING COMMITTEE.

    ``(a) Establishment.--Not later than 30 days after the date of the 
enactment of the Improving Science in Chemical Assessments Act, the 
Administrator of the Environmental Protection Agency shall establish a 
chemical hazard identification and dose-response steering committee 
(referred to in this Act as the `steering committee') 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. 
    ``(b) Duty.--The duties of the steering committee are the 
following:
            ``(1) 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.
            ``(2) 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).
    ``(c) Chair; Composition.--
            ``(1) Chair.--The steering committee shall be chaired by 
        the Assistant Administrator of the Office of Research and 
        Development of the Environmental Protection Agency.
            ``(2) Composition.--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.
    ``(d) Meetings.--The steering committee shall meet at least once 
each calendar year.
    ``(e) Third-Party Assessment Requirements.--The requirements 
specified in this subsection with respect to a third-party assessment 
of a chemical substance are that the assessment--
            ``(1) is conducted using scientific standards specified in 
        section 7B;
            ``(2) has undergone independent scientific review for 
        transparency, completeness, and quality; and
            ``(3) reflects the best available science and the weight of 
        the available scientific evidence. 

``SEC. 7B. SCIENTIFIC STANDARDS.

    ``Covered assessments carried out under section 7 and discussion of 
such assessments and review of third-party assessments carried out 
under section 7A, 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--
            ``(1) 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;
            ``(2) the extent to which the scientific information is 
        relevant for the relevant program office's use in making a 
        decision about a chemical substance;
            ``(3) 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;
            ``(4) 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;
            ``(5) the extent of independent verification or peer review 
        of the scientific information or of the procedures, measures, 
        methods, protocols, methodologies, or models;
            ``(6) the ability of the scientific findings and research 
        to be replicated or reproduced; and
            ``(7) the extent to which the available scientific 
        information supports dose-response modeling, using non-linear 
        approaches.''.
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