The U.S. Environmental Protection Agency (EPA) issued in June final framework rules under the Toxic Substances Control Act (TSCA). Each is summarized below.
The rule is intended to identify first high-priority substances that have the greatest hazard and exposure potential. The rule clarifies that a “low-priority” designation means that a risk evaluation isn’t warranted at this time, and that the EPA hasn’t determined no “unreasonable risk.” A “high-priority” designation doesn’t mean unreasonable risk; it is a designation signaling further review.
The rule added new elements including: a statement of the EPA’s intent to collaborate with other agencies; an objective concerning low-priority designations stating that the EPA is committed to making such designations beyond the statutory minimum; a statement that all TSCA Work Plan chemicals will be prioritized; and references to the EPA’s commitment to meet the sound science provisions under Section 26. The rule also included discussion of the new testing authority in Section 4(a)(2) and the Section 4 provisions regarding tiered testing and vertebrate animal testing.
Risk Evaluation Rule
This rule codifies the process by which the EPA evaluates risks from chemical substances under TSCA Section 6. This rule defines a process with standards and features unique to the TSCA. The EPA incorporated the scientific standards under Section 26 and provided definitions for key terms that appear in the rule for specific components of the risk evaluation process. Some definitions were incorporated but not codified. The definitions for aggregate exposure, pathways, routes, and uncertainty and variability reflect current agency policies and practices. The definition for sentinel exposure follows approaches widely used by government institutions in Canada and the European Union. The definitions for systematic review, sufficiency of information, and unreasonable risk were crafted to reflect the evolving nature of the activity and the flexibility necessary to adapt to changes in practices.
Among the codified definitions, some signal a policy shift. The EPA states that it interprets the mandates under Sections 6(a) and (b) to conduct risk evaluations and any corresponding risk management to focus on uses for which manufacturing, processing or distribution in commerce is intended, known to be occurring, or reasonably foreseen to occur prospectively or ongoing. This approach would exclude evaluation of the risks associated with legacy uses, associated disposal and legacy disposal.
Inventory Notification Rule
A number of significant changes were made here. The EPA withdrew its proposal to include the activity type and dates of activity, recognizing that the required recordkeeping provides the EPA the necessary documentation of the reported commercial activity. The proposal to require dates of activity was especially problematic because records older than five years may not be routinely available and the nature of some manufacturing, processing and importing practices are highly variable, making it difficult for reporters to specify a date range.
The EPA also clarified which substances must be reported. Any substance for which a Notice of Commencement (NOC) was filed in the lookback period satisfies the requirement to demonstrate commercial activity; the EPA will add these to the list of interim active substances that already included substances reported under the 2012 or 2016 Chemical Data Reporting (CDR) cycles.
A critical problem that the EPA addressed in the final rule relates to the transition period between June 22, 2016, and when the list of active substances is published. The proposed rule required an Notice of Activity (NOA) for activity in the lookback period (prior to June 22, 2016) and NOA submissions for inactive substances after the publication of the list of active substances. There was no provision for an NOA for commercial activity that occurred between June 22, 2016, and the publication of the list. To prevent this situation, the EPA has implemented a 90-day period after the final list is published in which manufacturers can submit a prospective (Form B) NOA for a substance that appears as inactive on that list.
The rules have not yet been published in the Federal Register, but are expected to be soon.
LYNN L. BERGESON is Chemical Processing's Regulatory Editor. You can e-mail her at email@example.com
Lynn is managing director of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm that concentrates on conventional, biobased, and nanoscale chemical industry issues. She served as chair of the American Bar Association Section of Environment, Energy, and Resources (2005-2006).