The EPA has published a final rule establishing content requirements and deadlines for electronic data submissions that will allow the Agency to designate chemicals in the Toxic Substances Control Act’s (TSCA) Chemical Substance Inventory as either active or inactive. The rule is required by the 2016 TSCA amendments to clarify the status of the more than 84,000 chemicals in the TSCA Inventory.
Retrospective and forward-looking
The rule applies in two ways to manufacturers (a term that includes importers) and processors of chemicals listed on the TSCA Inventory.
- First, under a retrospective requirement, manufacturers have 180 days from publication of the rule (August 11, 2017, FR) to report to the EPA if they manufactured or processed a chemical on the Inventory during the 10-year period ending June 21, 2016. Processors have 420 days after publication in the FR to report if they have processed chemical substances on the Inventory over the same 10-year period. If no notice is received during this retrospective reporting period for a substance subject to designation on the Inventory, that substance will be designated as inactive.
- Second, a forward-looking provision applies to chemical substances on the Inventory designated as inactive. Any person who intends to manufacture or process an inactive chemical substance must also report to the EPA not more than 90 days before the anticipated date of manufacturing or processing the inactive chemical substance. As soon as the Agency processes the notification, the chemical’s designation will be changed from inactive to active.
Notification contents
The rule requires that manufacturers and processors reporting for the retrospective reporting period provide chemical identity information and indicate whether they seek to maintain an existing claim for protection against public disclosure of a chemical identity claimed as confidential business information (CBI). Regarding forward-looking reports, any person who intends to manufacture or process an inactive substance for a nonexempt commercial purpose must provide the EPA with chemical identity information, the anticipated date of manufacturing or processing, and whether he or she seeks to maintain an existing CBI claim.
CBI
Notices may contain two types of CBI assertions: claims for protection of information other than specific chemical identity and requests to maintain existing claims for protection of specific chemical identity. In response to comments on the proposed rule, the EPA says it extensively rewrote the substantiation questions to more succinctly secure responses for CBI assertions of discrete data elements as well as CBI concerns about the linkage of data elements.
Reporting forms
The EPA has developed two reporting forms: Notice of Activity Form A (EPA Form No. TBD-1) will be used for retrospective reporting; Notice of Activity Form B (EPA Form No. TBD-2) will be used for forward-looking reporting.
Exemptions
The EPA notes that there are entries in the TSCA Inventory that are exempt from reporting because they do not meet the definitions of a chemical substance, a chemical substance subject to commercial activity, or a reportable chemical substance, all of which are subject to notifications. Exempted chemical substances include polymers, some chemicals used in research, and chemicals used in test marketing. Under TSCA, none of these substances can be designated as active or inactive and are, therefore, not subject to reporting. Other reporting exemptions apply to chemicals used for an exempt commercial purpose and chemicals for which the EPA already has an equivalent notice.