What This Bill Does
This bill changes how the Environmental Protection Agency (EPA) evaluates whether chemicals are toxic. Instead of using one centralized program called the Integrated Risk Information System, different EPA offices that handle specific environmental areas will conduct these evaluations themselves. The bill also creates a committee to prevent multiple EPA offices from doing duplicate work on the same chemicals.
Who It Affects
The EPA and its various offices including the Office of Water, Office of Air and Radiation, Office of Land and Emergency Management, and Office of Chemical Safety and Pollution Prevention will be directly responsible for conducting chemical safety assessments. Congress, specifically the House committees on Science, Space and Technology and Energy and Commerce, and the Senate Committee on Environment and Public Works, will receive reports about these assessments.
Key Provisions
• Different EPA offices must conduct chemical toxicity assessments instead of a single centralized program, as long as the office determines there is a need for the assessment (Sec. 7(b))
• When assigning toxicity values to chemicals, EPA offices must include a range of estimates and explain the sources of uncertainty in those estimates when scientifically supported by available data (Sec. 7(c))
• The EPA must create and maintain a chemical assessment database containing all toxicity values assigned to chemicals, including all assessments previously stored in the IRIS database (Sec. 7(d))
• A steering committee of 15 EPA employees must be established within 30 days to coordinate assessments and prevent duplicate work by different EPA offices on the same chemical (Sec. 7A(a))
• The steering committee must meet at least once per calendar year (Sec. 7A(d))
What Changes
Chemical toxicity assessments will move from the centralized Integrated Risk Information System program to individual EPA program offices. All previously completed assessments in the IRIS database will be transferred to a new chemical assessment database. A new steering committee will oversee this work to eliminate duplication.
Important Definitions
• "Covered assessment" means evaluations of human health effects from long-term exposure to a chemical substance, specifically a chemical hazard identification and dose-response assessment (Sec. 7(f)(1))
• "Relevant program office" includes the Office of Water, Office of Air and Radiation, Office of Land and Emergency Management, Office of Chemical Safety and Pollution Prevention, and any successor offices the EPA Administrator determines to be relevant (Sec. 7(f)(2))
Effective Date
The bill takes effect on the date of enactment, which is specified in the bill as "the date of the enactment of the Improving Science in Chemical Assessments Act" (Sec. 7(b)). The steering committee must be established within 30 days of enactment (Sec. 7A(a)). The certification reports to Congress must begin 2 years after enactment and then every 2 years thereafter (Sec. 7(e)).
I
118TH CONGRESS
1ST SESSION
H. R. 120
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 9, 2023
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
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•HR 120 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) IN GENERAL.—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) 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 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
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•HR 120 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) TOXICITY VALUES.—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) 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 data-
25
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•HR 120 IH
base to be maintained by the Office of Research and
1
Development of the Environmental Protection Agen-
2
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 Environ-
6
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 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) CERTIFICATION.—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
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•HR 120 IH
by the report was conducted using the scientific standards
1
specified in section 7B.
2
‘‘(f) DEFINITIONS.—In this section, section 7A, and
3
section 7B:
4
‘‘(1) COVERED 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) RELEVANT 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
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•HR 120 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 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) 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
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•HR 120 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
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•HR 120 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
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•HR 120 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
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