EPA has released a prepublication copy of a proposed TSCA section 8(a) rule that would require risk information reporting by manufacturers and processors of nanomaterials in the last 3 years and 135 days before doing so in the future.  This looks like a sneaky SNUR (significant new use rule) but doesn’t stop anyone from continuing or starting new manufacture or processing.  It is intended to allow EPA to look at potential risks and need for future regulation.

EPA describes reportable nanomaterials as

“A reportable chemical substance is a chemical substance that is solid at 25 ºC and atmospheric pressure that is manufactured or processed in a form where the primary particles, aggregates, or agglomerates are in the size range of 1-100 nm and exhibit unique and novel characteristics or properties because of their size. A reportable chemical substance does not include a chemical substance that only has trace amounts of primary particles, aggregates, or agglomerates in the size range of 1-100 nm, such that the chemical substance does not exhibit the unique and novel characteristics or properties because of particle size. " [see rule for more details]

There are exemptions: ZnO, nanoclays, DNA/RNA/proteins, nano on surfaces, ions <1 nm.

Information to be reported (electronically) is pretty open-ended: properties, use, "detailed methods" of processing, exposures to anyone, releases, risk management practices, plus any existing health and environmental effects data.  This will doubtless get better nailed down for the final rule.  No report is required if the chemical was already reported to EPA under PMN or the Nano Stewardship Program.

Who has to report:  manufacturers, of course, but also processors.  Strangely, EPA doesn't really discuss the implications for processor reporting.  Except in the preamble EPA states :

"Chemical substances that are manufactured or processed in a nanoscale form solely as a component of a mixture, encapsulated material, or composite would also have to be reported."

Another major departure is to define "small" business that are exempt as only having sales less than $4 million/yr, regardless of quantity of nano made/processed.

EPA says the rule will cost companies $13.9 million in the first year and $1.5 million in subsequent years. Wow.

If your company deals with or is thinking about working with nano materials, read and comment on this proposal!

[Update:  Comment period now open until Aug 5, 2015]

Leave a reply