EPA Final Rule to Change Certain TSCA Export Notification Requirements, Etc.

According to EPA sources, virtually all chemical substances or mixtures (chemicals) subject to TSCA 12(b) export notification regulations will be affected by one or more aspects of this final rule.

(Section 12(b) of the TSCA requires any person who exports or intends to export a subject chemical, if certain actions are taken under TSCA, to notify the EPA of such exportation or intent to export. A list of chemicals subject to TSCA section 12(b) export notification requirements (current as of 11/14/06) is available at http://www.epa.gov/opptintr/chemtest/pubs/main12b.pdf.)

Final Rule Creates De Minimis Exception, Reduces Notification Frequency, Etc.

Highlights of the changes to the TSCA 12(b) export notification regulations under the final rule include (partial list):

Export notification no longer required for certain de minimis concentration levels. The EPA is establishing de minimis concentration levels below which notification will not be required for the export of any chemical that is the subject of an action under TSCA section 4, 5, 6, or 7.

Specifically, notification will not be required for the export of (1) a subject chemical if present in a concentration of less than 1% (by weight or volume)¹ (2) a subject chemical that is a known or potential human carcinogen if present in a concentration of less than 0.1% (by weight or volume)², or (3) polychlorinated biphenyl chemicals (PCBs) if present in a concentration of less than or equal to 50 ppm (by weight or volume)³.

One-time notification to the EPA of export. The EPA's final rule changes the current requirement for annual notification to the EPA to a one-time requirement for exporters of subject chemicals for which certain actions have been taken under TSCA.

Specifically, this final rule applies a one-time requirement for each of the following TSCA section 12(b)-triggering actions per each destination country for each exporter of a subject chemical: An order issued, an action pending, or an action granting relief under TSCA section 5(e), a proposed or promulgated rule under TSCA section 5(a)(2), or where the submission of data is required under TSCA section 4 or 5(b).

(For the export of subject chemicals under TSCA section 4, the current regulations already require only a one-time notification to the EPA.)

For exports of chemicals that are the subjects of TSCA section 12(b)-triggering actions under TSCA section 5(f), 6, or 7, however, each exporter continues to be required to submit annual export notifications to EPA.

One-time EPA notification to foreign governments of export. For the same TSCA actions described above, the final rule also changes the current requirement that the EPA notify foreign governments annually after its receipt of export notifications from exporters to a requirement that the EPA notify foreign governments once after it receives the first export notification from an exporter.

Minor amendments. According to the EPA, the final rule also makes minor amendments, such as updating the EPA addresses to which export notifications must be sent, indicating that a single export notification may refer to more than one section of TSCA where the exported chemical is the subject of multiple TSCA actions, and correcting an error in 40 CFR 799.19 that currently omits mentioning multi-chemical test rules as being among those final TSCA section 4 actions that trigger export notification.

The final rule also clarifies exporters' and EPA's obligations where an export notification-triggering action is taken with respect to a chemical previously or currently subject to export notification due to the existence of a previous triggering action.

(According to a document published by ChemAlliance, the following is an overview of sections 4, 5, 6, and 7 of TSCA:

Section 4. Section 4 requires manufacturers, importers, and processors of certain chemicals to conduct testing on the health and environmental effects of chemicals, unless they qualify for an exemption.

Section 5. Section 5 regulates anyone who plans to manufacture or import a "new" chemical for commercial purposes. A premanufacture notice (PMN) for these "new" chemicals must be submitted to EPA. In addition, Section 5 requires information to be submitted on significant new uses of existing chemicals.

Section 6. Section 6 regulates certain hazardous chemicals and authorizes EPA to take regulatory action to protect against unreasonable risk of injury to human health or the environment due to the manufacture, import, processing, distribution in commerce, use or disposal of a chemical.

Section 7. Section 7 authorizes EPA to commence a judicial action for seizure of a chemical or article containing such a chemical which EPA has determined is imminently hazardous, and/or for other relief against any person who manufactures, imports, processes, distributes in commerce, uses, or disposes of an imminently hazardous chemical.)

¹ except as provided in (2) or (3)

² as described in the final rule

³ see final rule for details regarding the definition of PCBs, information on PCB articles, etc.

(See ITT's Online Archives or 03/08/06 news, 06030820, for BP summary of the EPA's proposed rule.)

EPA final rule (EPA-HQ-OPPT-2005-0058, FRL-8101-3, FR Pub 11/14/06) available at http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/pdf/E6-19182.pdf

EPA technical correction to final rule (EPA-HQ-OPPT-2005-0058, FRL-8104-9, FR Pub 11/28/06, available at http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/pdf/E6-20148.pdf

ChemAlliance document on the background of TSCA available at http://www.chemalliance.org/Handbook/background/back-tsca.asp