The CSIA’s Purpose, Findings, and Intent
To frame the discussion of these provisions, we first examine the purpose, findings, and intent of the CSIA. An important takeaway from these statements is the need to use sound science in regulating chemicals, to ensure safety while fostering innovation and economic competitiveness, and to do so through a comprehensive federal system.
Thus, the stated purpose of the CSIA is “to improve the safety of consumers” and “ensure that risks from chemical substances are adequately understood and managed by modernizing” the TSCA. S. 1009, § 2(a). This modernization of the TSCA via the CSIA is premised on the finding, among others, that “scientific understanding of chemicals and the possible risks of the chemicals has evolved greatly since 1976, requiring that Congress update the law to ensure that chemical regulation in the United States reflects modern science, technology and knowledge.” Id., section 2(b) (emphasis added). Congress’s intent is that the Environmental Protection Agency (EPA) shall “rely on robust scientific evidence to implement [the CSIA] in a way that balances the mutual goals of promoting the safety of American consumers and preventing harm to American innovation, manufacturing, and the economy; and . . . [so as] to protect the health of the people of the United States and the environment in such a manner as not to unduly impede commerce or create unnecessary economic barriers to technological innovation, including safer chemistry.” Id. (emphasis added).
Other admonitions regarding the use of “modern” and “robust” science are found in the recitations of the CSIA’s policy bases, e.g., that the EPA “should have the appropriate hazard, use, and exposure information necessary to make safety determinations”; should employ “best laboratory practices to ensure high quality, relevant, and reliable results from test methods and studies”; and “should implement this Act in a manner that promotes transparency of information and decisionmaking, protects substantiated confidential business information, and promotes innovation, including innovation in chemical substances that have reduced hazard, exposure, and risk patterns.” Id.
Finally, the sponsors set forth that this framework of modern and robust science is achievable only a federal level, i.e.,
for the purposes of promoting uniform protections through regulation of chemical substances in commerce, to minimize undue burdens on commerce, and to minimize burdens on States, specified actions by the Administrator should preempt requirements by States and political subdivisions of States that relate to the effects of or exposure to a chemical substance under the intended conditions of use.
Notably, the preemption provisions have garnered significant resistance, for example, from Senator Barbara Boxer (D-CA). Attorneys general from nine states presented a letter opposing the CSIA’s preemption provisions at the July 31, 2013, Senate hearing.
New TSCA Definitions
Notably, the CSIA introduces several new terms into the TSCA lexicon, again emphasizing the use of modern and robust science to regulate chemicals, as explored further below in describing the new “chemical assessment framework.” These defined terms include:
BEST AVAILABLE SCIENCE — The term “best available science” means science that —
(A) maximizes the quality, objectivity, and integrity of information, including statistical information;
(B) uses peer-reviewed and publically available data; and
(C) clearly documents and communicates risks and uncertainties in the scientific basis for decisions.
INTENDED CONDITIONS OF USE — The term “intended conditions of use” means the circumstances under which a chemical substance is intended or reasonably anticipated to be manufactured, processed, distributed in commerce, used, and disposed of.
SAFETY ASSESSMENT — The term “safety assessment” means a risk-based assessment of the safety of a chemical substance that —
(A) integrates hazard; use; and exposure information about a chemical substance; and
(B) includes —
(i) an assessment of exposure under the intended conditions of use; and
(ii) reference parameters that may be appropriate with regard to a specific chemical substance (such as a margin of exposure).
SAFETY DETERMINATION — The term “safety determination” means a determination by the Administrator as to whether a chemical substance meets the safety standard under the intended conditions of use.
SAFETY STANDARD — The term “safety standard” means a standard t\hat ensures that no unreasonable risk of harm to human health or the environment will result from exposure to a chemical substance.
S. 1009, § 3.
Chemical Assessment Framework
A key facet of the TSCA reform is a new “chemical assessment framework,” as set forth in section 4 of the CSIA. These provisions repeatedly set forth the requirement of sound science as the fundamental basis for chemical regulation, including that the EPA develop “a framework . . . for evaluating the safety of chemical substances in commerce that shall employ the best available science and risk assessment principles in existence at the time the Administrator is developing the framework.” S. 1009, § 4(a)(1). The scheme seems to reflect into the regulatory arena something of a juxtaposition of the familiar Daubert and similar devices employed by the courts to weed out junk science. Indeed, explicitly building such requirements into the regulatory process appears to be acknowledged in a new TSCA provision expressly providing that a safety determination for a high-priority substance “shall be admissible as evidence in any public or private action in any court of the United States or State court for recovery of damages or for equitable relief relating to injury to human health or the environment from exposure to a chemical substance.” S. 1009, § 15.
The chemical-assessment framework contains requirements that the EPA develop and use an “evaluative framework for decision-making” and a prioritization of chemicals to be the subject of safety assessments and safety determinations. The evaluative framework requirements provide:
(A) IN GENERAL — The Administrator shall develop and use a structured evaluative framework consisting of science-based criteria, consistent with the protection of human health and the environment, for making any decision under this Act, and for determining the relevance, quality, and reliability of data and information.
(B) CONTENTS — The framework described in subparagraph (A) shall, at a minimum —
(i) use sound and objective scientific practices in assessing risks;
(ii) consider the current best available science (including peer-reviewed studies);
(iii) when consistent with the underlying data, consider, for both cancer and noncancer endpoints, whether available data support or do not support the identification of threshold doses of a chemical substance below which no adverse effects can be expected to occur; and
(iv) include a description of the weight of the scientific evidence concerning risks, including mechanistic information (such as appropriate modes of action).
S. 1009, § 4(b)(5).
Statutorily requiring the “best available science,” see the definition above, and specific elements such as consideration of mechanism and mode of action, and threshold dose, provides a mandate for an exacting scientific inquiry. In a similar vein, the focus on “intended conditions of use” would appear to heighten the importance of considering with greater precision exposure scenarios, consonant with the fundamental toxicological principle that the dose makes the poison.
Furthermore, the CSIA expressly requires transparency in the formulation of these frameworks and procedures, directing the EPA to make publicly available “the data and information considered . . . in taking action under this Act” including “the guidance, procedures, and tools used in evaluating data and information under this section, including models, studies, and, as appropriate, the data underlying any study.” In addition, “[a]ny written guidance of general applicability prepared by the Administrator under this Act shall be subject to public notice and an opportunity for comment.” S. 1009, § 4(d).
Safety Assessments and Safety Determinations
The EPA is then charged with conducting safety assessments and safety determinations, as provided under section 6 of the CSIA. Once again, the statutorily mandated methodology for making safety assessments and safety determinations expressly incorporates specific scientific principles from the disciplines of epidemiology, toxicology, and exposure science. The requirements are:
(A) IN GENERAL — The Administrator shall —
(i) develop an appropriate science-based methodology for conducting safety assessments under this subsection, which shall include consideration of the weight of the evidence for observed effects, mechanistic information, and exposure evaluations; and
(ii) make the proposed methodology available for public comment and scientific peer review.
(B) REVIEW AND REVISIONS — Not later than 5 years after the date of enactment of the Chemical Safety Improvement Act, and not less frequently than once every 5 years thereafter, the Administrator —
(i) shall review the methodology developed under subparagraph (A); and
(ii) may revise the methodology to reflect new scientific developments or understandings, in accordance with subparagraph (A).
(C) REQUIREMENTS — The methodology shall apply scientifically recognized factors to address the following topics:
(i) Strengths and limitations of study design.
(ii) Reliability and relevance of test methods to human health and the environment.
(iii) Quality of data.
(iv) Use of good laboratory practices.
(v) Peer review and peer review processes.
(vi) Use of standardized protocols.
(vii) Structured evaluative frameworks to determine the overall weight of the evidence, based on a review of positive and negative findings.
(D) HAZARD, USE, AND EXPOSURE INFORMATION —
(i) IN GENERAL — A safety assessment under this subsection shall evaluate existing hazard, use, and exposure information for the chemical substance under the intended conditions of use of the chemical substance, including information submitted by interested persons.
(ii) EXPOSURE — For purposes of evaluating exposure under clause (i), a safety assessment shall take into consideration —
(I) exposures or significant subsets of exposures;
(II) exposure duration, intensity, frequency, and number; and
(III) the vulnerability of exposed subpopulations.
(E) BEST AVAILABLE SCIENCE — The Administrator shall use the best available science in conducting a safety assessment under this subsection.
S. 1009, § 6(b).
The EPA is required to “make available to the public the information taken into consideration in preparing each safety assessment and determination [and] to publish and provide an opportunity for comment on proposed safety assessments and determinations.” Id.
Once the safety assessment is completed, the EPA is required to make a “safety determination,” i.e., “whether the chemical substance meets the safety standard under the intended conditions of use of the chemical substance.” S. 1009, § 6(c). The determination may be (i) the chemical meets the safety standard under the intended conditions of use; (ii) the chemical does not meet the safety standard, in which case the EPA can impose restrictions on the chemical; or (iii) additional information is required. The rules governing the safety determination include:
(3) CONSIDERATIONS — In making a safety determination under this subsection, the Administrator shall take into consideration and publish a statement that includes, at a minimum —
(A) the safety assessment for the chemical substance, including the uses considered in the assessment and any uses that are considered critical or essential;
(B) the range of exposure to the chemical substance under the intended conditions of use of the chemical substance and appropriate reference parameters;
(C) the weight of the evidence of risk posed by the chemical substance under the intended conditions of use of the chemical substance; and
(D) the magnitude of the risk posed by the chemical substance under the intended conditions of use of the chemical substance.
(4) INFORMATION SOURCES In making a safety determination under this subsection, the Administrator shall take into consideration, at a minimum —
(A) the information described in section 4(c); and
(B) the safety assessment conducted with respect to the chemical substance under subsection (b).
(5) BEST AVAILABLE SCIENCE — The Administrator shall use the best available science in making a safety determination under this subsection.
(6) NOTICE AND COMMENT — Subject to section 14, the Administrator shall provide notice and an opportunity for public comment on each proposed safety determination under this subsection.
(7) TRANSPARENCY — Subject to section 14, the Administrator shall publish —
(A) each safety determination under this subsection, together with a summary of the information considered in the determination;
(B) a summary of the evaluation by the Administrator of the information; and
(C) an explanation of the reasons for the determination.
A “safety determination” is a “final agency action” and is subject to judicial review, which review would also bring up the underlying safety assessment. Id. Consequently, the various scientific safeguards built into the regulatory process by the CSIA’s statutory mandates for the best available science may be enforced also by the courts.
The proposed CSIA makes great efforts to ensure, by statutory mandate, that modern and robust science is employed in the regulation of chemicals, and that such science be transparent and open for public comment. While it remains to be seen whether the legislation will be adopted, and how the agencies and the courts will implement the regulation, the premise that the “best available science” should be the driver in the decision making would seem to be unassailable.
Keywords: litigation, mass torts, Toxic Substances Control Act, Chemical Safety Improvement Act, EPA