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115th Congress  }                                       {  Rept. 115-1101
                         HOUSE OF REPRESENTATIVES
 2d Session     }                                       {     Part 1

======================================================================



 
             IMPROVING SCIENCE IN CHEMICAL ASSESSMENTS ACT

                                _______
                                

               December 21, 2018.--Ordered to be printed

                                _______
                                

     Mr. Smith of Texas, from the Committee on Science, Space, and 
                  Technology, submitted the following

                              R E P O R T

                        [To accompany H.R. 6468]

    The Committee on Science, Space, and Technology, to whom 
was referred the bill (H.R. 6468) 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, having considered the same, 
report favorably thereon without amendment and recommend that 
the bill do pass.

                                CONTENTS

                                                                   Page
Committee Statement and Views....................................     1
Section-by-Section...............................................     3
Explanation of Amendments........................................     3
Committee Consideration..........................................     3
Roll Call Votes..................................................     3
Application of Law to the Legislative Branch.....................     5
Statement of Oversight Findings and Recommendations of the 
  Committee......................................................     5
Statement of General Performance Goals and Objectives............     5
Duplication of Federal Programs..................................     5
Disclosure of Directed Rule Makings..............................     5
Federal Advisory Committee Act...................................     5
Unfunded Mandate Statement.......................................     5
Earmark Identification...........................................     6
Committee Estimate...............................................     6
Budget Authority and Congressional Budget Office Cost Estimate...     6
Changes in Existing Law Made by the Bill as Reported.............     6

                     Committee Statement and Views


                          PURPOSE AND SUMMARY

    The purpose of H.R. 6468, the ``Improving Science in 
Chemical Assessments Act,'' is to give the relevant program 
offices within the Environmental Protection Agency (EPA) the 
primary authority to carry out hazard identification and dose 
response assessments on chemical substances. The effect would 
be to make these assessments more efficient and responsive to 
the regulatory need of the program offices. The legislation 
also prescribes scientific standards for the assessments to 
ensure transparency and accuracy.

                  BACKGROUND AND NEED FOR LEGISLATION

    H.R. 6468 remedies deficiencies in the Integrated Risk 
Information System (IRIS) program at EPA. Since 2009, the 
Government Accountability Office and the National Academy of 
Sciences have issued multiple reports criticizing the IRIS 
program. The most common criticisms involve a lack of 
transparency, procedural flaws, and improper science. IRIS 
assessments can take up to ten years or more to complete and 
are often not needed or irrelevant by the time they are 
finished. Therefore, this legislation is necessary to continue 
the program's core functionality at the agency and make the 
products of these assessments more relevant to current 
regulatory activity.

                          LEGISLATIVE HISTORY

    On September 6, 2017, the Subcommittee on Environment and 
the Subcommittee on Oversight of the Committee on Science, 
Space, and Technology held a hearing entitled, ``Examining the 
Scientific and Operational Integrity of EPA's IRIS Program.'' 
The purpose of this hearing was to examine the EPA's IRIS 
program. The hearing focused on scientific and operational 
integrity issues related to the functionality and goals of the 
IRIS program. Witnesses were: Dr. Kenneth Mundt, Principal, 
Ramboll Environ; Dr. James Bus, Senior Managing Scientist, 
Exponent; and Dr. Thomas Burke, Professor, Bloomberg School of 
Public Health, Johns Hopkins University.
    On July 23, 2018, H.R. 6468, the ``Improving Science in 
Chemical Assessments Act,'' was introduced by Environment 
Subcommittee Chairman Andy Biggs.
    On July 24, 2018, the Committee on Science, Space, and 
Technology met to consider H.R. 6468, the ``Improving Science 
in Chemical Assessments Act.'' The Committee ordered the bill 
to be reported to the House by a recorded vote of 17-13.

                            COMMITTEE VIEWS

    The Committee recognizes the importance and continued need 
for hazard identification and dose response assessments carried 
out by EPA. This legislation decentralizes the function within 
the agency for purposes of making the assessments more relevant 
to the regulatory needs of the program offices. To maintain 
consistency and prevent duplication in this new construction, 
the legislation creates a steering committee housed in the 
Office of Research and Development (ORD). Lastly, the 
legislation codifies scientific standards for carcinogen risk 
assessment. These standards are derived from those existing in 
current law under the Toxic Substances Control Act as well as 
EPA's own Guidelines for Carcinogen Risk Assessment.

                           Section-by-Section


Section 1. Short title

    This section establishes the short title of the bill as the 
``Improving Science in Chemical Assessments Act.''

Section 2. Research needs and priorities of EPA program offices

    This section amends section 7 of the Environmental 
Research, Development, and Demonstration Authorization Act, and 
adds new sections 7A and 7B.
    Section 7, as amended by H.R. 6468, ensures that covered 
assessments conducted by the EPA are responsive to the needs of 
the program offices by directing chemical assessments 
previously conducted by the IRIS Program to be carried out by 
the relevant program office within EPA. It also promotes 
reliability and completeness by ensuring that covered 
assessments will be carried out using the best available 
science and based on the weight of the scientific evidence. 
Program offices are directed to assign a toxicity value or 
values to the chemical substance when supported by the 
available data.
    Section 7A creates a steering committee led by the ORD to 
coordinate the chemical assessments to promote consistency and 
prevent duplication of assessments. The steering committee has 
the authority to consider third party assessments as 
supplements to the covered assessments being carried out by the 
program offices provided they reflect the best available 
science and the weight of the available scientific evidence.
    Section 7B ensures the science is complete and accurate, 
requiring EPA to consider the relevance and completeness of the 
data, as well as whether the findings are reproducible as a 
factor in determining its influence in generating the toxicity 
values.

                       Explanation of Amendments

    There were no amendments to this bill.

                        Committee Consideration

    On July 24, 2018, the Committee met in open session and 
ordered reported favorably the bill, H.R. 6468, by roll call 
vote, a quorum being present.

                            Roll Call Votes



              Application of Law to the Legislative Branch

    Section 102(b)(3) of Public Law 104-1 requires a 
description of the application of this bill to the legislative 
branch where the bill relates to the terms and conditions of 
employment or access to public services and accommodations. 
This bill gives the relevant program offices within EPA the 
primary authority to carry out hazard identification and dose 
response assessments on chemical substances. As such this bill 
does not relate to employment or access to public services and 
accommodations.
    Legislative branch employees and their families, to the 
extent that they are otherwise eligible for the benefits 
provided by this legislation, have equal access to its 
benefits.

  Statement of Oversight Findings and Recommendations of the Committee

    In compliance with clause 3(c)(1) of rule XIII and clause 
(2)(b)(1) of rule X of the Rules of the House of 
Representatives, the Committee's oversight findings and 
recommendations are reflected in the descriptive portions of 
this report.

         Statement of General Performance Goals and Objectives

    H.R. 6468, the ``Improving Science in Chemical Assessments 
Act,'' will give the relevant program offices within the 
Environmental Protection Agency (EPA) the primary authority to 
carry out hazard identification and dose response assessments 
on chemical substances.

                    Duplication of Federal Programs

    No provision of H.R. 6468 establishes or reauthorizes a 
program of the Federal Government known to be duplicative of 
another Federal program, a program that was included in any 
report from the Government Accountability Office to Congress 
pursuant to section 21 of Public Law 111-139, or a program 
related to a program identified in the most recent Catalog of 
Federal Domestic Assistance.

                  Disclosure of Directed Rule Makings

    The Committee estimates that enacting H.R. 6468 does not 
direct the completion of any specific rule makings within the 
meaning of 5 U.S.C. 551.

                     Federal Advisory Committee Act

    The Committee finds that the legislation does not establish 
or authorize the establishment of an advisory committee within 
the definition of 5 U.S.C. App., Section 5(b).

                       Unfunded Mandate Statement

    Section 423 of the Congressional Budget and Impoundment 
Control Act (as amended by Section 101(a)(2) of the Unfunded 
Mandates Reform Act, P.L. 104-4) requires a statement as to 
whether the provisions of the reported include unfunded 
mandates. The Committee estimates that H.R. 6468 contains no 
intergovernmental or private-sector mandates as defined in the 
Unfunded Mandates Reform Act.

                         Earmark Identification

    H.R. 6468 does not include any congressional earmarks, 
limited tax benefits, or limited tariff benefits as defined in 
clause 9 of rule XXI.

                           Committee Estimate

    The Committee estimates that implementing H.R. 6468 would 
have no effect on direct spending or revenue.

     Budget Authority and Congressional Budget Office Cost Estimate

    The Committee advises that a Congressional Budget Office 
cost estimate was not available at the time this report was 
printed.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italic, and existing law in which no 
change is proposed is shown in roman):

 ENVIRONMENTAL RESEARCH, DEVELOPMENT, AND DEMONSTRATION AUTHORIZATION 
                                  ACT




           *       *       *       *       *       *       *
  [Sec. 7. (a) 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 program 
offices, as well as the overall research needs and priorities 
of the Agency, including those defined in the five-year 
research plan.
  [(b) For purposes of subsection (a), the appropriate program 
offices are--
          [(1) the Office of Air and Waste Management, for air 
        quality activities;
          [(2) the Office of Water and Hazardous Materials, for 
        water quality activities and water supply activities;
          [(3) the Office of Pesticides, for environmental 
        effects of pesticides;
          [(4) the Office of Solid Waste, for solid waste 
        activities;
          [(5) the Office of Toxic Substances, for toxic 
        substance activities;
          [(6) the Office of Radiation Programs, for radiation 
        activities; and
          [(7) the Office of Noise Abatement and Control, for 
        noise activities.
  [(c) The Administrator shall submit to the President and the 
Congress a report concerning the most appropriate means of 
assuring, on a continuing basis, that the research efforts of 
the Agency reflect the needs and priorities of the regulatory 
program offices, while maintaining a high level of scientific 
quality. Such report shall be submitted on or before March 31, 
1978.]

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:
          (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 this 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.

           *       *       *       *       *       *       *