America used to be a chemistry powerhouse: It's the nation that made teflon, Super Glue, and Magic Grow dinosaurs. But recently, the number of new chemical substances approved by federal regulators has dropped by half.
That's because last summer Congress issued reforms to the Toxic Substances Control Act, a 30 year old law governing how the EPA and other federal agencies check the boxes that let new chemicals come to market. Industry groups say these significant changes to the review process are to blame, while agency officials say it’s nothing more than temporary growing pains during the initial transition. But one thing seems clear---the slowdown is real.
The Toxic Substances Control Act has been around since early days of the EPA; it gives the agency oversight over a wide range of commercial, industrial and consumer applications of microbial biotechnology---pretty much anything potentially harmful to humans or the environment that’s not food, drugs, cosmetics or pesticides.
That approval process changed significantly on June 22, 2016, when Congress passed an amendment called the Frank R. Lautenberg Chemical Safety for the 21st Century Act. Before, the agency had the authority to take action and halt approval if they found cause for concern with a new substance. But, if they they didn’t, they could simply dropped the review and the chemical could proceed. Now, by law, the EPA must give a full review to every substance, and only those that pass can go to market.
During those first six months prior the 2016 update---under the old review process---the EPA dropped the review of 81 new chemical substances, effectively OK-ing them for market. For cases reviewed between June 23, 2016 and the end of the year, the agency found only 39 substances to be “not likely to present reasonable risk,” the new affirmative head nod toward commercialization. That leaves hundreds of applications stuck in review limbo, with the backlog growing bigger every day.
As a result, some chemists feel like they must dial back their ambitions to pass review. “New chemicals are taking significantly longer to get through the EPA process now,” says Rich Engler, a chemical consultant with environmental law firm Bergeson & Campbell. “If I were advising a client I would tell them to only try to develop something low hazard, because those are the only ones proceeding through right now." Engler previously worked for 17 years as a senior staff scientist in the EPA’s Office of Pollution Prevention and Toxics.
At face value, safe seems better. But while new regulations might keep dangerous chemicals in their beakers, other, more innocuous substances often get unfairly flagged as presenting some level of risk. These include genetically modified microorganisms being used to create all kinds of new chemicals. The term GMO might raise the hackles of people fearing gene-hacked corn and frankenfish, but in regulatory lingo it is a really broad term encompassing some really uncontroversial organisms. These include: Yeasts that fart ethanol; fungi that secrete cellulose; algae that poop biofuels; bacteria that digest oil spills; and a host of other commercially useful microbes that have been spliced with genetic material outside their own genus.
A handful of these helpful GMOs have made it through the post-reform Toxic Substances Control Act EPA (some yeasts and a few fungi with extensive histories of safe use). But chemists and companies are concerned that increased data burdens in the new EPA regulations are stifling efforts to engineer solutions from unlikely places, even as advances in gene editing makes it quicker and easier than ever to do so. In a public meeting the agency convened in December, industry groups urged the EPA to reassess the changes to the new chemicals program.
But besides pulling in additional staff to handle all the new paperwork, there's not a whole lot the agency can do. The Toxic Substance Controls Act reforms from last summer were passed by Congress, and are therefore law. Even the most regulations-averse EPA head would still be statutorily obligated to enforce the new process. Not even president-elect Trump could undo them, should he decide he wants to Make America Formulate Again.
