Regulatory Developments

American Chemistry Council: Redundancy Not Needed in TSCA Reset Rule

The regulated sector has generally gone along with Congress’s major June 2016 amendments to the Toxic Substance Control Act (TSCA), as well as the various notices and proposals the EPA is issuing to implement those revisions. One action for which industry has voiced support is the Agency’s proposal to reset the TSCA Chemical Substance Inventory (Inventory) (January 13, 2017, FR). The TSCA amendments specifically require that the EPA determine which of the 85,000 entries in the Inventory are active and which are inactive in U.S. commerce. The proposal would impose certain notification requirements on industry to allow the Agency to make such determinations. The American Chemistry Council (ACC) notes that the proposal “is generally well-tailored to avoid unnecessary or duplicative notifications” but could be “further refined to reduce burdens on both the Agency and industry” (see ACC comment letter; docket no. EPA-HQ-OPPT-2016-0426-0060).

Forward-Looking, Also

The major provision in the proposal would require persons who manufactured an Inventory chemical substance for nonexempt commercial purposes during the 10-year time period ending on June 21, 2016, to notify the Agency. This lookback period is set by statute. The proposal would also establish procedures for forward-looking electronic notification of chemical substances on the TSCA Inventory, which are designated inactive, if and when the manufacturing or processing of such chemical substances for nonexempt commercial purposes is expected to resume.

Prior Knowledge, Date Range, and Updates

The ACC comment letter comprises 12 recommendations to improve requirements that would be included in a final rule. Most of these recommendations are concerned with technical, definitional, and clarity issues. Following are three ACC recommendations aimed at more substantial proposed requirements.

  • The EPA should acknowledge active chemicals in commerce of which it has knowledge without the need for redundant notifications. The ACC believes the EPA should not require duplicate reporting of any nonconfidential substance for which the Agency already has reliable and readily available information to confirm manufacture during the lookback period. For example, any substance for which the EPA has received a Notice of Commencement reporting manufacture or import during the lookback period clearly meets the definition of an active substance. “Duplicate reporting of substances for which EPA already has data to establish that the chemical substance was in active commerce during the lookback period is unnecessary,” says the ACC.
  • The proposed requirements to report a date range and to differentiate domestic manufacture from importation are unnecessary and should be removed. A substance qualifies as active if it was domestically manufactured or imported at any time during the lookback period. The statute does not require reporting of date ranges nor particular documentation of the date (or date range) a chemical was manufactured or imported. “Locating records to establish conclusively first and last dates of manufacture would be significantly more burdensome than the effort to simply verify that a substance had been manufactured during the relevant period,” notes the ACC. “This is particularly the case when companies or business units have been sold, shut down, or merged.”
  • The EPA should regularly post an updated, current list of substances identified as active during the reset—“One and Done.” The EPA proposes that each manufacturer must report every nonexempt chemical manufactured during the past 10 years. Because many chemicals are manufactured by more than one company, the agency will receive multiple reports of manufacturing for a given chemical. Only one notification is needed to identify an active chemical. “All subsequent reports are duplicative and unnecessary, and impose an unnecessary burden on industry as well as EPA,” states the ACC. “A more efficient alternative would be for EPA to post on its website a current list of all chemicals identified as active to date, which would allow manufacturers to avoid duplicative reporting of chemicals already identified as active.”

The ACC also recommends that the EPA double the time from for joint reporting (from 180 days to 360 days), establish a formal mechanism for correcting the active list, and clarify that information is “not reasonably available” if it is not in the possession or control of manufacturers or importers.