The chemical business environment is changing in some ways that, I fear, add even more disadvantage to small chemical manufacturers. The regulatory sphere is closing in on our chemical manufacturing industry like shrink wrap around a gutted salmon. Whereas it was once straightforward to bring a new chemical product to the B2B market, now we have TSCA and Department of Homeland Security (DHS) placing complex obstacles in the road.
TSCA compliance for non-listed compounds requires that process details be disclosed for screening and hazard modeling by EPA workers. Unless the EPA finds some compelling environmental or worker exposure issue that requires further consideration, a new compound is allowed.
Operating unsafely is a poor business model. Civil litigation and insurance pressures are usually enough to motivate a plant operator to conduct safe practices. Regardless, if you’re in the business of breaking trail in developing new chemical entities, waiting for allowance by EPA necessitates starting the development timeline up to a full quarter in advance. TSCA filing also starts an audit trail that, for the unwary, can lead to a filing cabinet full of discoverable documents that can return to haunt you. TSCA is powerful code and it is one of the larger hammers that the government wields.
Before the chemical regulatory epoch began in earnest, chemical processing merely delt with the forces of the market and of nature. Corrosives, flammable liquids, runaway reactions, foreign competition, etc. That was dangerous enough and required the full attention of many experts.
Today, in addition to chemical hazards we have administrative hazards that require specially trained staff and, naturally, lawyers. Law office charges to document compliance may cost as much per hour as a whole shift of operators for a medium scale process line.
The federal government is beginning to impose itself more strongly in the operations of chemical plants. Part of this is in response to international terrorism. Like children sitting in a darkened room telling ghost stories, federal regulators have stirred themselves into a twitter. Apparently, they have developed fault trees that line out the universe of consequences from attack scenario’s on our chemical industrial infrastructure. Code has been written and passed by the congress, signed by the president, and embraced by the suffocating bosom of the Department of Homeland Security. Woe is he who runs afoul of these people. Their para-military authority and zeal is what makes me uncomfortable.
If only we could be so analytical and systematic about invading and destabilizing prickly iron-age cultures on the other side of the world.
Of course, one cannot entirely fault the government for trying to apply the Precautionary Principle. It seems so sensible. But the eternal question is, what are the thresholds for action? Where safe meets sorry is also where the rubber meets the road. How much more industry are we going to chase to Asia?
On the non-security side, Europe has adopted REACH. I’m trying not to be a Chicken Little, but before the US adopts this approach to environmental regulation, we should study the suite of unintended consequences that will surely arise from this regulatory framework. The EU is breaking trail for us and we should pay attention.
Lamentations on Chemistry 
I haven’t had much experience with TSCA at al, but have had a fair share with medical device regulations GxP, QSR, … It’s the same griping. Someone recently proposed this question: despite all the carping, would you really do things any differently if all the regulations went away? (Especially given the omnipresent lawyers who seem to appear and disappear with some Casimir-like ghoulishness.) It caught me flat-footed, and I can’t really think of much that I would change. Sure, some small details here and there, but all in all, I wouldn’t change much. Is TSCA that much different?
Hi John, I think that some kind of civil litigation threat will be there irrespective of what’s in the CFR. My concern is with the effect of complex regulations on innovation and start-up businesses.
Starting a chemical company from scratch- two guys with a napkin in Starbucks- is substantially more complex than starting many other kinds of businesses. In addition to the usual pragmatics of finance and business structure, a chemical startup has to peel a regulatory onion that now goes from city zoning through homeland security.
The people who are technically versed enough to get a startup chemical company putting out product- chemists- are woefully prepared to deal with payroll accounting, much less the maze of OSHA, TSCA, State health Department, Fire Department, documentation requirements, etc, that must be done to get a chemical company going.
It is a major disincentive for startups and practically pushes entrepreneurs into the teeth of venture capitalists. The best way to lose control of your venture is to go to these people. It is a disincentive because it necessarily requires a large and expensive burst of expensive expertise from the beginning.
My stance on this is that there needs to be some pushback on the ever present stream of new regulations piling on top of the already big heap. Some pushback already happens by industrial lobbyists, but the scientific community needs to speak out as well.