As we briefly mentioned yesterday, Rep. John Shimkus (R-IL) released a new version of his proposal to reform the Toxic Substances Control Act (TSCA), the Chemicals in Commerce Act (CICA), and announced that another hearing on the bill will be held on Tuesday, April 29. Witnesses have not yet been announced.
The changes in the latest version of CICA do not constitute a major overhaul. Many of the changes in the bill are essentially changes in structure and nomenclature – for example, the “safety determinations” discussed in the initial “discussion draft” are renamed “risk evaluations.” Much discussion of scientific standards and considerations EPA must make in assessing scientific information – such as the use of a “weight of the evidence” approach – are stripped throughout the bill, only to be re-consolidated in new subsections on “Scientific Standards” and “Weight of Scientific Evidence.” However, the new version of CICA does remove requirements that EPA develop and establish specific standard practices and criteria for developing and evaluating high quality, reliable, and valid data.
The bill’s risk standards have also changed; previously, EPA was to determine whether new chemicals are “likely to result in” an “unreasonable risk of harm” to human health or the environment, but the new version instead asks if the chemical “may present” an unreasonable risk of harm. Chemicals are to be designated as low priority if EPA determines, based on available information, that the chemical is “not likely to present a significant risk of harm” under the intended conditions of use. In evaluating the risk of high priority existing chemicals, the Administrator is to determine whether a chemical might present, “in the absence of regulation,” a significant risk of harm under its intended conditions of use.
The new version of CICA elaborates on the risk evaluation (formerly “safety determination”) process – for example, specifying factors to be considered as well as factors not to be considered. Factors in the former category include the nature, circumstances, severity and magnitude of risk, as well as whether harm has occurred from the chemical under its intended conditions of use. In the latter category, EPA is precluded from considering the economic costs or benefits of either the intended use of the chemical or reducing the exposure of the chemical via rule. If a risk evaluation results in a determination of no significant risk, then that determination – which must be published, but is not required to be subject to public notice and comment rules – is considered a final agency action, and would not result in any further regulation (although EPA may choose to review risk evaluations). A determination of significant risk, however, does not become a final agency action until EPA promulgates a rule imposing restrictions or requirements “to protect adequately against an unreasonable risk of harm.” The updated CICA also adds a deadline for this section: risk evaluations must be published within four years of a chemical’s designation as high priority, although another provision authorizes EPA to grant extensions as necessary “but not to exceed a cumulative period of 3 years.”
Other changes to the updated CICA include:
- Defines and incorporates more references to “potentially exposed subpopulations,” for example, effects on potentially exposed subpopulations are a factor that must be considered when EPA assigns a priority to an existing chemical;
- Specifies in the definition of “intended conditions of use” and throughout the bill (e.g., as a test marketing activity that might qualify for a Section 5 exemption) that “disposal” is a covered activity (along with manufacturing, processing, etc.);
- Strikes the notice and comment and Administrative Procedures Act requirements previously applied to “Risk-Based Exemptions” for new chemicals or uses;
- Authorizes EPA to require manufacturers and processors to develop hazard and exposure information for priority designation purposes, upon the determination “that available information is not sufficient to make a priority designation”;
- Adds an “Alternative Risk Evaluation” provision authorizing EPA to conduct a risk evaluation for a substance that is not designated as high-priority, to determine that the substance will not present a significant risk of harm in the absence of regulation and under specific conditions of use;
- Adds a requirement that, in issuing a rule imposed on a chemical after making a significant risk determination, EPA must provide for a “reasonable” transition period for implementation; and
- If considering a rule that would prohibit or substantially prevent a specific use of a chemical, EPA must determine whether technically and economically feasible alternatives “that benefit human health or environment, compared to the use proposed to be prohibited or substantially prevented,” will be “reasonably available as a substitute” when the rule would take effect. The discussion draft’s comparison point was whether the alternatives “materially reduce risk.”
A key sticking point for the bill’s detractors has been its express preemption provision, but the new CICA does not make substantial changes on this issue. If enacted, it appears that CICA would effectively preempt almost any state efforts to regulate or request information on chemicals covered by TSCA – except, perhaps, if the state law or regulation does not regulate the chemical substance under its intended conditions of use.
Chemical Watch reports that House Democrats have been negotiating with Rep. Shimkus on resolving their concerns with CICA, such as the scope of preemption. However, it appears that some disagreement among House Democrats remains as to the likelihood of reaching a resolution; Rep. Henry Waxman (D-CA), the Energy and Commerce Committee Ranking Member, reportedly remains concerned about establishing a “health-based safety standard,” among other issues. Currently, CICA is the only proposal on the House side; meanwhile, according to Chemical Watch, there is still no clear timeline for putting out a new version of the bipartisan bill in the Senate, the Chemical Safety Improvement Act.