H. R. 6399
IN THE HOUSE OF REPRESENTATIVES
July 17, 2018
Mr. Biggs (for himself, Mr. Smith of Texas, Mr. Lucas, Mr. Norman, Mr. Rohrabacher, Mr. Posey, Mr. Weber of Texas, Mr. Babin, Mr. Higgins of Louisiana, Mrs. Lesko, Mr. Hultgren, Mr. Abraham, Mr. Webster of Florida, Mr. Marshall, Mr. Dunn, Mr. Westerman, and Mr. Moolenaar) introduced the following bill; which was referred to the Committee on Energy and Commerce
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.
This Act may be cited as the
Chemical Assessment Improvement Act.
Hazard Identification and Dose Response Assessments
Beginning on the date of the enactment of this 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 scientific standards specified in section 4 and be based on the weight of the scientific evidence.
In carrying out such an 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:
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.
When multiple point estimates can be developed, the relevant program office shall—
consider all datasets; and
make a determination about how best to represent the human health risk posed by the chemical substance involved.
Chemical assessment database
A toxicity value or values assigned to a chemical substance under subsection (b) shall be included in a chemical assessment database to be maintained by the Office of Research and Development of the Environmental Protection Agency.
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).
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.
In this section:
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).
The term relevant program office includes the following offices of the Environmental Protection Agency:
The Office of Water.
The Office of Air and Radiation.
The Office of Land and Emergency Management.
The Office of Chemical Safety and Pollution Prevention.
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.
Hazard Identification and Dose Response Steering Committee
Not later than 30 days after the date of the enactment of this Act, the Administrator of the Environmental Protection Agency (referred to in this Act as the
Administrator) 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.
The duties of the steering committee are the following:
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.
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).
The steering committee shall be chaired by the Assistant Administrator of the Office of Research and Development of the Environmental Protection Agency.
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.
The steering committee shall meet at least once each calendar year.
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—
is conducted using scientific standards specified in section 4;
has undergone independent scientific review for transparency, completeness, and quality; and
reflects the best available science and the weight of the available scientific evidence.
Covered assessments carried out under section 2 and discussion of such assessments and review of third-party assessments carried out under section 3, 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—
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;
the extent to which the scientific information is relevant for the relevant program office’s use in making a decision about a chemical substance;
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;
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;
the extent of independent verification or peer review of the scientific information or of the procedures, measures, methods, protocols, methodologies, or models;
the ability of the scientific findings and research to be replicated or reproduced; and
the extent to which the available scientific information supports dose-response modeling, using non-linear approaches.