Does the Toxic Substances Control Act (TSCA) apply to renewable chemicals?

Yes, renewable chemicals are chemical substances and, as such, are subject to TSCA.  TSCA authorizes EPA to regulate chemical substances, defined broadly to include "any organic or inorganic substance of a particular molecular identity."  Renewable chemicals include substances of a particular molecular identity; that these substances may be derived from renewable feedstocks does not preclude application of regulation under TSCA.  All renewable chemicals under TSCA’s jurisdiction and not exempt are required either to be listed on the TSCA Inventory or be submitted for review by EPA as a new chemical. 

Are renewable chemicals considered "new chemicals" under TSCA?

Many renewable chemicals can be considered "new chemicals" under TSCA.  TSCA Section 8(b)(1) directs EPA to compile and keep current a list, commonly referred to as the TSCA Chemical Substance Inventory, of each chemical substance that is domestically manufactured or imported into the U.S.  The TSCA Inventory was initially created in the late 1970s, during a time when commercial chemistry was largely petroleum-based.  While renewable chemicals were present on the original TSCA Inventory, their number and variety were limited in comparison to petroleum-based substances.  As such, many of the renewable chemicals entering the market will be considered "new chemicals" subject to TSCA Section 5 notification. 

What is a Premanufacture Notice (PMN) and how does it apply to renewable chemical substances?

Under TSCA Section 5, anyone planning to manufacture or import a new chemical (see above) for non-exempt commercial purposes must provide EPA with a notice before initiating the activity.  The PMN must be submitted at least 90 days prior to the manufacture or import of the chemical.

A renewable chemical under TSCA's jurisdiction that is not listed on the TSCA Inventory and not exempt must be submitted for review by EPA as a "new chemical" (see above).  The PMN requirement may be avoided if Inventory listing for the chemical can be established.  The process by which a renewable chemical that is structurally similar to an already existing, Inventory-listed petroleum counterpart is considered a "new chemical" and may be determined based on naming rules. 

How does EPA apply naming rules and conventions to biobased chemicals?

The Chemical Abstracts Service (CAS) Chemical Abstract (CA) Index Names and Registry Numbers (CASRN) is used under TSCA and is widely accepted around the world as a consistent and valid method of identifying chemicals.  EPA and the Soap and Detergent Association (SDA, now the American Cleaning Institute) jointly developed a system for naming chemical substances derived from natural fats and oils and their synthetic substitutes.  This system, referred to as the SDA Nomenclature system, may be of special relevance to renewable chemical substances derived from natural fats and oils.

EPA applies CAS nomenclature in naming TSCA Inventory chemicals, although EPA may also follow a number of naming conventions that are or can be distinct from a strict CAS approach.  These conventions may be based on the way EPA approached the naming of a particular chemical or are derivative of approaches outlined in EPA documents that provide guidance in the naming and identification of TSCA-regulated chemicals. 

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