Long-awaited amendments to Toxic Substances Control Act (TSCA) Section 12(b) export notification regulations were recently issued by the U.S. Environmental Protection Agency (EPA). The amendments diminish export reporting requirements, long regarded by many as overly burdensome.
The reporting rules
TSCA Section 12(b) requires exporters to notify EPA, in writing, if they export chemical substances or mixtures that are subject to certain rules or orders. EPA has interpreted this requirement literally, meaning a notification was required regardless of how trivial an amount of a chemical may be in an exported product. The notification allows EPA to inform the country of destination that a chemical subject to a TSCA rule or order is coming its way. Failure to comply can give rise to civil penalties, enforcement actions, and/or seizures.
Chemicals subject to export notification requirements are those for which: data have been required; an order has been issued; a rule has been proposed or issued; and an action is pending or relief has been granted.
Export notifications must be submitted to EPA for the first export of a regulated chemical substance to a particular country within each calendar year that TSCA Section 12(b) requirements apply. For chemicals subject to Section 4 test rules, only a one-time export notification must be filed for the first export to a country. The notice must be postmarked within seven days after the exporter has accepted a contract or an equivalent intra-company agreement to export. If the EPA action prompting a notification is a proposed rule, the requirement to submit a notice begins 30 days after publication in the Federal Register.
Two amendments are especially important to chemical manufacturers and processors. The first changes the notification requirement for exporters of chemicals for which TSCA actions have been taken from annually to a one-time basis for each of the following triggering actions per each destination country for each exporter of a chemical: an order issued, an action pending, or an action granting relief; a proposed or issued rule; or an action requiring the submission of data. Exporters of chemicals subject to triggering actions continue to be required to submit annual notifications. [Its not clear how this annual notification differs from whatn now not required annually,per the previous sentence.] EPA also changed the frequency with which it must notify foreign governments after its receipt of notifications from exporters.
The second important change is EPAs issuance of long-awaited de minimis concentration levels below which notification wont be required for the export of any chemical for which notification is otherwise required. Notification wont be required for the chemicals if exported at concentrations of less than 1% (by weight or volume), unless it is a known or potential human carcinogen.
For purposes of TSCA Section 12(b) export notification, the chemical is: listed as a known to be human carcinogen or reasonably anticipated to be human carcinogen in the National Toxicology Programs Report on Carcinogens; classified as a Group 1, Group 2A, or Group 2B carcinogen by the International Agency for Research on Cancer (IARC) in the list of IARC Monographs on the Evaluation of Carcinogenic Risks to Humans and their Supplements; or characterized as a carcinogen or potential carcinogen in the Occupational Safety and Health Administrations (OSHA) regulations related to toxic and hazardous substances (29 C.F.R. Part 1910, Subpart Z). For chemicals falling into one of the listed categories, a de minimis concentration level of less than 0.1% (by weight or volume) applies. For exports of polychlorinated biphenyls (PCB), EPA wont require notification if the exported chemicals are at a concentration of less than or equal to 50 parts per million (by weight or volume).
These new thresholds are very important and provide much needed reporting relief for exporters whose products contain small concentrations of chemicals subject to TSCA rules or orders. For exporters who may not have always been compliant with the current rule, the change offers welcomed prospective freedom from enforcement action for failure to submit notifications for exports that, but for the de minimis exemption, would otherwise be subject to TSCA Section 12(b).
Cause to celebrate
Final TSCA rules are usually unwelcomed by stakeholders in the chemical community. This final rule, effective January 16, greatly alleviates reporting obligations and is cause to celebrate.