Alert: EPA Suggests Ceramic, Cement Products, and Other Glasses and Alloys May Require TSCA Pre-Manufacture Notices

June 20, 2008

In May 2008, the EPA issued a letter suggesting that manufacturers of inorganic glass, cement, metal alloys, and other materials may be subject to the Toxic Substances Control Act (TSCA) requirements for marketing of new chemical substances.  This interpretation of TSCA upsets 28 years of settled regulatory understanding.

In 1980, EPA published the initial TSCA Inventory, which included 58,000+ chemical substances already on the market.  Certain complex and "variable" materials, not commonly considered to be chemicals, to be reported under TSCA as "statutory mixtures."  The Inventory included, among other materials, cement, glass oxide, frits (glass compounds typically used in pottery and porcelain), ceramic materials, and other products. 

Until the May EPA letter (from the Chief of the Industrial Chemistry Branch of EPA in response to a letter from the American Chemistry Council dated 26 November 2007), manufacturers of "statutory mixtures" relied on the initial TSCA Inventory to conclude that their products are not new chemical substances requiring advanced notice to the market, or pre-manufacture notices (PMNs).

The EPA letter, however, directs that the initial Inventory listings should not be interpreted to include products such as "ceramics, if the commercial manufacture of these substances involves new chemical bonding."  Although troublesome and controversial, EPA now takes the position that the term "ceramics" has evolved in the intervening 28 years to refer now to "ceramic-like materials" best defined by their composition, and therefore requiring more control during their manufacture.  According to this interpretation, materials not listed separately by compositional elements (something that has not been done for the products of concern here) on the TSCA Inventory will be subject to the PMN requirements under TSCA Section 5.

As a result, customers of companies supplying these products may well begin requiring certification that the products they receive are TSCA-compliant.  More significantly, EPA could now require manufacturers to suspend production and distribution of these products pending submission and review of a PMN.  It should also be noted that penalties of up to $32,500 per day can be assessed for products marketed in violation of TSCA Section 5. 

If your company manufactures, processes, or uses these products, you should carefully evaluate the implication of this development and develop an approach to EPA that protects your commercial position.  We would be pleased to assist you in this evaluation process.

For your reference, here are links to the ACC letter and the EPA response letter.