10.01.2018 Frequent TSCA Questions: Chemical Processor Reporting
|Click here for related articles.|
The 2016 amendments to the Toxic Substances Control Act (TSCA) required EPA to designate chemical substances on the TSCA Chemical Substance Inventory as either “active” or “inactive” in U.S. commerce. To accomplish that, EPA established a retrospective electronic notification of chemical substances on the TSCA Inventory that were manufactured (including imported) for nonexempt commercial purposes during the 10-year period ending on June 21, 2016, with provision to also allow notification by processors. EPA will use these notifications to distinguish active substances from inactive substances. Notifications by manufacturers using a Notification of Activity Form A were due on February 7, 2018. Notifications by processors of chemicals for which a manufacturer did not file a Form A are due by October 5, 2018. If no one files a Form A for a particular chemical substance during the notification periods, that substance will be designated as “inactive” when EPA publishes its updated TSCA Inventory near the end of this year. Substances not on EPA’s Active Chemical List (ACL) by February, 2019 may not be distributed in commerce in the United States without a pre-filing notice to EPA moving the substance to the ACL.
These requirements have raised a number of questions in the regulated community. A few of these questions are addressed below.
QUESTION: What chemical substances require designation on the ACL or by default will fall into inactive status?
ANSWER: “Chemical substances subject to commercial activity designation” (Designated Chemicals) must be on the ACL or moved to the ACL by October 5, 2018. This includes all chemical substances currently in the TSCA Inventory, which (1) are not considered an “interim active chemical substance” because no person included the chemical on a chemical data report (CDR) filed with EPA prior to 2017; (2) were not added to the TSCA Inventory before June 21, 2016; (3) are not “naturally occurring”; and (4) are not currently on the ACL.
QUESTION: Are chemicals designated confidential or otherwise not listed on a safety data sheet (SDS) excluded from the ACL requirements?
ANSWER: Yes and No. While a processor need not submit a Form A for chemical substances on the ACL where the person has evidence in the form of a Central Data Exchange (CDX) receipt documenting that another entity submitted the Form A for that substance, EPA guidance states that the processor “bears the risk of failing to report if [the processor] rel[ies] on the CDX receipt exemption and the Form A notice (for which they have a CDX receipt) is later withdrawn, leaving the substance being designated as inactive.”
QUESTION: What are pre-conditions for exempting the processor from filing a Form A for byproducts generated during a manufacturing process?
ANSWER: A processor need not file for inclusion on ACL those chemical substances qualifying as “byproducts,” if the byproduct’s only commercial purpose is to be (1) burned as a fuel, (2) disposed as a waste; or (3) further processed to extract component chemical substances for use in commercial purposes. This exclusion, of course, applies only to the byproduct, not to any substance extracted from the byproduct.
QUESTION: How does EPA define “processing” for purposes of the October 5, 2018 reporting deadline?
ANSWER: EPA clarifies the scope of the term “processors” by referring the regulated community to the word “process.” For purposes of the new reporting rule, process means “preparation of a chemical substance or mixture, after its manufacture [or import], for distribution in commerce.” This may involve keeping the chemical substance in its “same form or physical state as, or in a different form or physical state from, that in which it was received,” including processing “for use as an intermediate” in a final product.
QUESTION: What does EPA plan to do with chemical information received as part of the ACL filing?
ANSWER: According to the new amendments to TSCA, EPA must establish a system to review all ACL chemicals for risks to human health or the environment. Reviews of chemicals currently known to present risks – such as mercury and trichloroethylene (TCE) – are already underway.