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
into 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
▲ 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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