The Statutory Language

Any person who manufactures, processes, or distributes in commerce a chemical substance or mixture and who obtains information which reasonably supports the conclusion that such substance or mixture presents a substantial risk of injtuy to health or the environment shall immediately inform the Administrator of such information tmless such person has actual knowledge that the Administrator has been adequately informed of such information. 

The Administrative Procedure Act, 5 U.S.C. i 500, requires notice to the affected public and an opportunity for the public to comment before regulations are promulgated. 

Office of Toxic Substances, TSCA Section 8(e) Reporting Guide, 2 (June 1991) [hereinafter 1991 8(e) Guide]. 

In general, most submissions made to EPA under TSCA 8(e) contain toxicity data gathered during testing of commercial or research and development chemicals. However, certain types of information on exposure and environmental effects and release must also be reported. 

---

From our review of the statutory language of 103 as well as the application of that statute as spelled out in Graham v. John Deere, we have seen that obviousness is determined by an inquiry that initially takes into account the scope and content of the prior art, the differences between the claimed invention and the prior art, the level of skill of one of ordinary skill in the art, and any secondary evidence of nonobviousness. In a patent application examination at the USPTO, in order for an examiner to make an obviousness rejection of the invention, the examiner must present a prima facie case of obviousness. Prima facie is Latin for on the face of it, and it means that the patent examiner must put forth sufficient written argument or evidence in view of the appropriate legal precedence such that the claimed invention, as described in the specification and in view of the prior art,... 

The court acknowledged that the Commission could properly order manufacturers to furnish consumers with information concerning lawnmower rotation speed under Section 27(e) but that a warning label simply did not communicate performance and technical data within the scope of the statutory language. Id. 

The TSCA statute has an exemption from many of the TSCA requirements for substances that are manufactured, imported, processed, or distributed solely for export from the United States. The statutory language is tucked away in 12(a), which otherwise deals with export notifications. This exemption does not apply if the EPA has found that the substance will present an unreasonable risk of injury to health within the United States or to the environment of the United States. In other words, if there is a rule imder TSCA 6 then the substance is not exempt from any TSCA provisions. 

The EPA was constrained by the statutory language of TSCA 3(2), which says the term chemical substance means any organic or inorganic substance of a particular molecular identity. The EPA went on to say in the Inventory Status of Nanoscale Substances guidance that ... 

The Inventory regulations paraphrase the statutory language and add that mixtures include ... 

Manufacturers, importers, and some processors and distributors are subject to TSCA 8(c). The statutory language broadly applies TSCA 8(c) to all manufacturers, processors, and distributors of a chemical substance, and importers are also included because the term manufacture is defined in the TSCA statute to include import. EPA s regulations implementing this subsection create several exemptions to the statute s broad scope of coverage. Distributors who do not also manufacture or process the chemical substances are defined as sole distributors and are exempt. Retailers are also exempt provided that they distribute to ultimate customers that are not commercial entities and provided that they do not also manufacture or process the subject chemicals. ... 

While the statutory language requires reporting immediatel) the EPA has determined that this requirement is met if the information is submitted within thirty days. 68 Fed. Reg. 33129 (June 3, 2003). 

MTBE was a citizens suit under TSCA 20 seeking to compel oil companies to report certain information concerning methyl tertiary butyl ether under TSCA 8(e). As the MTBE case makes clear, people bringing citizens suits are not bound by EPA guidance that purports to relax strict compliance with the statutory language. Similarly, there is no reason why any other federal agency would be compelled to interpret TSCA the way the EPA does in the guidances. ... 

---