One of the banes of life for a scientist in fabulous industry is having to deal with regulatory compliance.  And, in my opinion, one of the thorniest to contend with is TSCA– Toxic Substances Control Act. Now, for those people who make the same thing day-in and day-out, TSCA is practically invisible. In this mode, your product is either on the list and therefore approved for manufacture, or management has applied for and received some exemption from the EPA.  But for those intrepid characters who are in the business of making new stuff or just lots of different stuff on a regular basis, the question of TSCA compliance is an ongoing minefield concern. 

TSCA is promulgated by the EPA.  Basically, TSCA regulates what isn’t already covered by food, drug, agrochemical, cosmetic, and nuclear material regulations.  TSCA covers chemicals and formulations used in R&D and in general manufacturing.  The TSCA inventory is maintained by Chemical Abstracts Service. With certain exceptions, what is on the TSCA list can be manufactured freely and in any quantity.  The TSCA inventory has a group of listings for public viewing and a confidential group of listings. The balance of chemicals in the universe are those that are not on the TSCA inventory. These are problematic for manufacturers.

One important complication for chemicals that are on the inventory is the SNUR– Significant New Use Rule.  Even though a chemical may be on the list, certain uses may be restricted. So if you plan on manufacturing a product that is on the TSCA inventory, you really should look for SNUR’s.

A chemical product that is not on the public or confidential TSCA inventory cannot be sold for commercial use in the USA. Perversely, you can manufacture for export only.  Products that are not on the inventory can be sold at any scale for R&D use only, however. 

Let’s say that something is on the confidential inventory.  Unless you know this, you would conclude that a chemical is not on the inventory. Well, guess what? You can’t just call the EPA to find out if a chemical is on the confidential inventory. You have to submit an application as if you were going to file for real. If it is confidential, then the EPA will notify you on the normal application timeline.

In order to manufacture something for commercial use that is not on the TSCA inventory, you either have to get it listed by filing a PMN (Premanufacturing Notice) or you file for an LVE (Low Volume Exemption).  Also, any raw materials and isolated intermediates in the process have to be listed. If not, you have to file for those as well. So, initiating the manufacture of new chemicals is complicated by the requirement of performing numerous filings.

LVE’s have a 30 day evaluation period. If you screw up the application, you have to resubmit it and the clock restarts at zero again. The EPA folks look at the chemical process and all of the chemicals and evaluate the potential for harmful exposure to people and the environment.  They use numerous modeling programs to estimate toxicity and potential environmental insult.

In parts of the physical world like the lab or a production area, it is possible to have a physical disaster like a spill, fire, or explosion. In the regulatory world, you have administrative disasters.  And these administrative- or compliance- calamities can be just as costly and career threatening as an actual disaster in the plant. Fortunately, in an administrative disaster the body parts lying around are just metaphors.

[Note: I am not a regulatory specialist.  I acknowledge that I am a mere laboratory wretch and therefore deeply marbled with imperfections and inhomogeneities.  As god dog is my witness, I am prostate prostrate in supplication before those with superior understanding of this topic. I welcome- nay, beg- corrections, comments, and lashings from those with superluminal understanding of this most sacred codex.]