Federal Regulatory Support:
Import/Export - Non-Exempt Chemicals (TSCA)

Importing Non-Exempt Chemicals

In order for non-exempt chemicals to be allowed entry into the United States, they must comply with regulations under the

Toxic Substances Control Act (TSCA)

. If a chemical is listed on the TSCA Inventory, it is considered an “existing” chemical, and unless the substance is subject to manufacture or use limitations, it can be imported New chemical substance complying with TSCA import requirementsinto the United States. If a chemical is not listed on the TSCA Inventory, it is considered a

“new” chemical substance

 and subject to TSCA section 5 Premanufacture Notice (PMN) requirements. After a PMN has been submitted and reviewed, a Notice of Commencement of Manufacture or Import (NOC) must be filed with EPA within 30 days of the manufacture or import of the substance. A chemical is considered an “existing” chemical as soon as a complete NOC is received by EPA. There are several exemptions to the PMN requirements, including the Research & Development Exemption, Low Volume Exemption (LVE), Low Release/Low Exposure Exemption (LoREXs) and the polymer exemption. Several of these exemptions, including LVEs and LoREXs, require submitting the appropriate exemption applications to EPA.

Once a chemical substance is ready for import, it must comply with all rules in effect under TSCA, including Section 13 import certification requirements.

Section 13 requires importers to sign a positive or negative certification statement, depending on whether or not the substance is subject to TSCA regulation. A positive certification statement implies that the chemical substance being imported is compliant with all applicable TSCA regulations. A negative certification is required for exempt chemicals not regulated under TSCA, such as pesticides, food, drugs and cosmetics.

TSG’s regulatory experts assist with all aspects of TSCA importation. When a new chemical is being imported into the United States, TSG helps companies through the PMN process and ensuing NOC filing. TSG also assists with the numerous exemptions to the PMN requirements, including LVEs, LoREXs, polymer exemptions and Research and Development Exemptions. In addition, TSG will assist companies with the various other issues that arise during chemical importation into the United States.

Exporting Non-Exempt Chemicals

Requirements under section 12(b) of TSCA require submission – within seven days – of a notice to EPA by any person who exports a chemical substance for which a rule or order has been promulgated, specifically:

▲ The submission of data is required under Sections 4 or 5(b);

▲ An order has been issued under Section 5;

▲ A rule has been proposed under Sections 5 or 6; and

▲ An action is pending, or relief has been granted under Sections 5 or 7.

TSG can assist companies in determining if or when export notification is required for their products or mixtures and can prepare and submit the required notices to EPA in a timely fashion.
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