Commercial chemicals exemption under chemical substances

Chemicals controlled under separate EC legislation are exempt from notification, as are existing chemical substances, which are defined as those listed in the European Inventory of Existing Commercial Chemical Substances (EINECS). This is an inventory of substances supplied within the EC from 1 January 1971 to 18 September 1981, which were reported for inclusion by the sujpliers. EINECS is a closed inventory, and any substances omitted in error cannot now be included. 

In addition to substances specifically excluded from the TSCA, the EPA has exempted other types of substances from certain TSCA requirements. For example, certain chemical substances—including certain impurities and byproducts—are excluded from TSCA Section 5 requirements because although they are manufactured for commercial purposes under the Act, they are not manufactured for distribution in commerce as chemical substances per se and have no commercial purpose separate from the substance, mixture, or article of which they are a part [10]. 

The TSCA Inventory, established under Section 8(b) ofthe Act, comprises substances considered to exist in US commerce. A substance not already included on the Inventory is considered to be a new chemical substance pursuant to TSCA Section 3(9). Under TSCA Section 5(a), a person must submit a Premanufacture Notification (PMN) to the EPA at least 90 days before commencing manufacture or import, for a commercial purpose, of a chemical substance not on the Inventory, unless the substance is exempt from reporting. After PMN review and upon receipt of a Notice of Commencement of Manufacture or Import (NOC), the EPA adds the chemical substance to the Inventory, which then becomes an existing chemical substance. Certain nanoscale substances that will be manufactured or imported for commercial purposes are expected to be new chemical substances and therefore subject to the TSCA new chemical reporting requirements, as are any other new chemical substances. 

Another example of a substance exempt from premanufacture notification under this section is a chemical that may be formed when fibers are made. If the fibers are used in a way that depends wholly or partially on their shape or design, and they do not undergo any chemical changes on end use except those chemical changes that have no commercial purpose apart from the item that they form a part of, then the fibers are articles. If new chemical substances are formed when a fiber that is an article is made from an existing chemical, those new chemical substances are exempt from the premanufacture notification requirements because of the (h)(6) exemption. 

An example of a substance exempted by the (h)(5) exemption is the chemical reaction product that is formed when paint dries. That same chemical would be subject to PMN regulations if it were intentionally made as a commercial product for distribution as a chemical product or an intermediate, but not when it is formed as a result of the use of paint. If the paint is applied to an article, then the chemicals formed on use of the paint are also exempt from the premanufacture notification requirements under the (h)(6) exemption. 

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