EPA effectively closed down any real opportunity to claim chemical identity confidential for new chemicals and for chemicals for which a health, safety or environmental study is submitted under TSCA.  See http://edocket.access.gpo.gov/2010/2010-12646.htm

The only protection is to keep your company confidential and patent the novel chemical identity (and good luck protecting that).  The only possible exception is if your chemical identity is a process description ("reaction product of...") rather than a molecular one.

There are some legitimate periods when chemical identity itself has tremendous economic value and little risk information value - the period prior to commercial manufacture.  That period of R&D is when studies will be done.  Some R&D studies may be reportable under section 8(e) according to EPA's over-expansive interpretation of that provision where exposure has no weight in the "substantial risk" determination and will be submitted with a PMN if the chemical looks commercially promising enough to do so.  Given the length of time it takes to move a PMN through EPA this could give significant lead time for competitors to pick up on the chemistry or a variant.

And the public's need to know on a chemical that isn't on the market?  Well, maybe it's got some structure relationship and could be informative on a category of chemicals . But in that case, a generic chemical description placing it in the relevant category could serve just as well.

Maybe the lawyers can find some wiggle room, but I doubt it.

The likelihood confidentiality be allowed in any reformed TSCA is nil.

Previous TSCA secret chemical post

1 Comments

Leave a reply