Raising the bar for chemical safety will spur, not stifle, innovation

. He says that imposing such a requirement would create a disincentive for companies to develop new chemicals, which he argues are safer than older chemicals as a rule. Finally, he points to experience in Europe, where far fewer new chemicals entered the market over the last few decades than in the U.S., as supporting his case. Let’s take each of these lines of argument in turn.

Unlevel playing field?

The first argument maintains that there’s an unlevel playing field, because new chemicals would have to provide their minimum data set before they could get on the market, whereas existing chemicals would be given some time to do so.

During this transition, there would indeed be a tilt. That’s a direct consequence of the fact that TSCA grandfathered in some 62,000 chemicals without requiring any safety testing. That’s a deep hole, one that can’t be climbed out of overnight.

Auer points to a provision of the Senate bill that would allow makers of existing chemicals up to 14 years to provide their data. But it’s the chemical industry, not those of us who think new chemicals need safety data, that successfully lobbied for that provision in the Senate bill. 

As I noted in a recent post, we want as short a transition as possible, and prefer the House discussion draft’s version of this provision (see section 4(a)(2)). That version would require data sets on existing chemicals within either 18 months of priority listing or five years of enactment – whichever comes first.

Of course, even if one accepts this line of argument, the status quo is even more tilted against new chemicals. Under current TSCA, new chemicals are subject to premanufacture notices, while existing chemicals have none. New chemicals are subject to EPA review, while existing chemicals have none. EPA can (and occasionally does) require testing of new chemicals through consent orders, while it virtually never requires testing of existing chemicals.

The solution to this problem is to expedite the requirement for minimum data for existing chemicals – not to do away with the requirement for safety data for new chemicals!

Should we presume new chemicals are safer?

Mr. Auer also claims new chemicals are safer as a rule, so we should readily allow them onto the market. I suppose the rationale is that they will somehow thereby supplant the older chemicals, improving the “average” safety of chemicals on the market over time.

Should we assume new chemicals are a prioi safer? One very recent cautionary example ought to begin to dispel the wisdom of such a presumption: Multi-walled carbon nanotubes (MWCNTs). These new marvels hold all kinds of promise in applications ranging from stronger composites to superconductive materials to photodetection. It so happens they are quite toxic: The are potent inducers of lung inflammation and fibrotic responses, and also seem to have a great deal in common with asbestos fibers, having been shown capable of crossing from the lung into the surrounding tissue and there inducing mesothelioma-like symptoms.

More generally, while the results of EPA’s new chemical reviews are held as top secret information, the European Union reports that its review of new chemicals over the years before REACH found that about 70% of them possessed at least one dangerous property (page 27).

There’s no reason to presume that new chemicals are less safe than existing ones, but the only way we’ll know is to require data sufficient to determine their safety.

And even if one believes a new chemical poses less risk at least initially because it isn’t used widely at the outset, the risk to workers making and handling it is present from day one. Safety data are essential to ensuring their protection.

More lessons from abroad

Finally, Mr. Auer points to the much lower rate of introduction of new chemicals in Europe than in the U.S. as evidence of the chilling effect of data requirements.

It’s true that only about 4,000 new chemicals entered the market in EU during the same time that nearly 20,000 new chemicals did so in the U.S. Mr. Auer argues that’s because the EU (even before REACH) had the audacity to require some actual data for new chemicals as a condition for their entering the market. 

First, lest you think those tree-hugging Europeans are somehow uniquely anti-new chemical, the U.S. is virtually alone in the developed world in not requiring an up-front minimum data set to inform government’s evaluation of new chemical safety; the EU does, of course, and Canada does, and Japan does.

I’ve noted in an earlier post that TSCA prohibits EPA from requiring a minimum data set for new chemicals. As a result, 85% of the premanufacturing notices EPA reviews contain no health data, and 95% contain no ecotoxicity data.

But more to the point, the differential rate of new chemical introduction in the U.S. versus the EU and its perceived implications for innovation was in fact a major motivation for the development of REACH; see White Paper, especially pp. 5, 8, 11-12 and 32.

And how did the EU go about leveling the playing field under REACH? Did it gut the data requirements for new chemicals? No; it raised the bar for existing chemicals, phasing in requirements over time that will require makers of all chemicals, whether new or existing, to provide data sufficient to demonstrate their safety.

Playing the China card

Unfortunately, there is a rather stale last stanza that’s been added recently to the industry’s song about innovation, a variation on an old theme: If you over-regulate us, you’ll just push the industry overseas.

In this case, it plays to the broader tune of the China blues: Innovation will still happen, the lyrics go, it’ll just happen in China.

First, it must be said that this refrain is rather hard to listen to, coming as it does from an industry that is already moving production overseas as fast as it can, and for reasons that have nothing to do with the environment or regulation.

But it’s also tone-deaf: It ignores the fact that the industry’s own customers, more than anyone else, are demanding more and better information about the chemicals they buy, more, not less, evidence of their safety.

Finally, it ignores the fact that the rest of the world is moving ahead faster than we are to address chemical safety. That includes even China, which bars domestic use of formaldehyde-laced plywood that we allow to be imported, which has reportedly translated the REACH regulation into half a dozen dialects, and which is modernizing its own laws along the lines of REACH.

Innovation, yes, but to what end?

In my view, one of the most egregious failings of TSCA has been its failure to incentivize innovation toward safer chemicals and products. Instead, it has perpetuated a chemicals industry that has little incentive either to replace existing chemicals – because they skate along without any scrutiny at all – or to ensure that new chemicals it does introduce are safe (or at least safer than the existing chemicals with which they will compete) – because the review they get is so cursory (data- and time-constrained) that it would catch and be able to stop only the most dangerous substances.

I support provisions in the Safe Chemicals Act of 2010 that would:

• provide an easier path onto the market for new chemicals the makers of which demonstrate their new chemicals are safer than other chemicals for the uses for which they are intended (see section 32 of the Act); and
• allow critical or essential use exemptions even for chemicals (whether new or existing) that fail the safety standard, where they fulfill vital purposes for which alternatives do not exist or can be shown to provide a net health or environmental benefit compared to the alternatives (see section 6(e)(2)).

Both of those provisions encourage the development of innovative new chemicals that are either demonstrably safer or meet an essential need.

Can anyone seriously think that any sort of desirable innovation can happen without ensuring safety? Safety ought to be at the core of innovation, rather than being seen as an impediment or afterthought. And in this, regulation can help rather than hurt.

As the EU’s White Paper made clear, stronger regulation through REACH was seen as vital not only to protecting health and the environment, but to shoring up the competitiveness of the EU’s chemical industry (the world’s largest), and putting it on a more sustainable footing. And smart companies made the connection. As REACH took effect in 2008, a DuPont spokesperson was quoted saying:

We are implementing REACH as a global program across DuPont, and the impact of REACH will be varied and widespread. We see it as potential to drive market innovation. There are chemicals that may be restricted under REACH, and it'll provide the opportunity for a science company like DuPont to develop replacement products to satisfy market needs. (emphasis added, Greenwire, 6/23/08)

But the chemical industry’s proposal – to allow new chemicals to enter commerce without being demonstrated to be safe, or in the more ominous version, without provision of even basic safety data – would do nothing more than compromise public health in the name of innovation.

That notion of innovation rings hollow and confuses the means with the end. It is one we are better off without.