It’s difficult to describe how badly the New Chemicals division in the Office of Pollution Prevention and Toxics (OPPT) at EPA is performing these days, but let me try. The commercialization of new chemicals (not on the TSCA Inventory) not otherwise regulated requires that new chemical substances (NCS) be reviewed and granted following a Pre-Manufacture Notice (PMN) or a Low Volume Exemption (LVE) submission under the Toxic Substances Control Act (TSCA), should they meet internal criteria regarding safety. Exposures and doses to workers or the environment may be measured by the applicant or modeled using EPA in-house software. R&D only chemicals are exempt from such evaluation no matter the scale.

The application process requires the disclosure of the NCS composition and structure, the manufacturing and/or use operation in considerable detail, physicochemical properties and, if available, a wide range of worker and environmental hazards. Imported chemicals not on the TSCA inventory also require TSCA approval just as though they were being manufactured in the USA. Food, drugs and pesticides are not controlled under TSCA. Under penalty of law, all submissions must have the best and most accurate available information, particularly with regard to hazard information. No fibbing allowed.

The issues I’m about to recount started sometime in early 2021. Some speculate that a particular interpretation of the law promulgated by TSCA was adopted. I can’t provide references, however.

By statute, an LVE filing for instance, must be examined and be given a grant, conditional grant, or denial within 30 days. It is currently taking much longer than that: 60 to 100 days or longer. I have some that are still pending after 7 months. PMN filings take longer to process, about 9-12 months. or worse.

Aren’t these delays just a petty annoyance? Well, no. Part of a new product development timeline is getting regulatory approval. If this approval is subject to large delays with uncertain outcomes, then the launch date can become very fuzzy. The consequence for the end user is that scheduling their production activity becomes impossibly vague. Denials of LVE and PMN filings are not uncommon. Don’t expect a lot of sympathy from customers about EPA problems.

The last thing you want is some plebe right out of school with no professional experience in commerce to be handing out the regulatory death penalty to your expensive new technology. Handling hazardous materials safely and without environmental harm is done all day every day all over the world. There is a saying in the chemical industry: If you think safety is expensive try having an accident. There is considerable financial incentive to running a chemical plant safely and within regulations.

There seems to be a troubling issue involving the assumptions that EPA makes in regard to handling the NCS. The feedback I receive suggests that the engineers and toxicologists are ruling based on the worst case exposures that they imagine are going to happen. They imagine that workers and the environment will be exposed to the NCS as if workers aren’t wearing personal protection equipment (PPE) or there was no barrier to the environment. You can plainly state that these exposures won’t happen and state why, but they want evidence evidence that they cannot define that something will not happen. In other words, they want proof of a negative.

Another problem with EPA seems to be the sophomoric view that chemical hazards can always be abated by using safer chemicals. There may be a speck of truth to this generalization. In the formulations industry, for example. Replacing hazardous ingredients in mascara or shampoo with those that are less hazardous may be quite uncomplicated. Reducing chemical hazards is part of ethical business operations and is expected with ISO 9001 registration. The catch for chemical manufacturing is that the chemical features that make chemicals reactive and hazardous are usually the same features that make them essential to synthesis. Except for solvents and filter aid, unreactive chemicals are not very useful in synthesis. Synthetic chemistry is about manipulating the reactive features of one molecule with another to yield a useful product.

The delay issue is not unknown to EPA. In fact they are painfully aware of it all the way up to the EPA administrator. The good folks at EPA are doing their best with absurdly limited resources. We’re told that the TSCA division is 50 % understaffed, and many of the staff they do have are inexperienced. They have a computer system that is obsolete by many generations. You can see this by filing on their website. They have taken to denying submissions that are flawed in a minor way rather than continuing to work with the applicant to fix the problem. This excess fastidiousness ratchets down their backlog, at least in the short term.

The problems at EPA stem from the inability of congress to buckle down and provide proper funding. Only congress can act to boost staffing or computers. Lobbyists are working on it but, unfortunately, this is not an appealing issue for a congress person to take up and run with. Maybe we can get that cancerous A-hole Tucker Carlson to howl about it on the tube. Then we might see some movement.