Richard Denison, Ph.D., is a Senior Scientist.
An emerging chemical industry talking point in TSCA reform is the claim that imposing new requirements on new chemicals will somehow stifle innovation. The milder manifestation of this perspective emanates from those who oppose requiring a safety determination for new chemicals unless they raise major red flags in an initial review.
But some in the industry go further, arguing that even requiring safety data for new chemicals would put the big chill on development of new chemicals.
I beg to differ with both arguments. This post will make the opposite case, and will also argue that true innovation embraces rather than shuns safety, and demands the information needed to demonstrate it.
Doesn’t safe mean … uh, safe?
The chemical industry has fought hard for a provision in TSCA reform legislation that would allow new chemicals onto the market without first having to undergo a safety determination. That approach has crept into the Safe Chemicals Act of 2010: The new TSCA section 5(a)(1)(B)(ii) would allow a new chemical to enter the market and remain there for an indeterminate length of time, as long as EPA finds that it does not and is not expected to flag any of several criteria.
These criteria include:
- high-volume production or environmental release;
- evidence that the chemical does or may possess certain toxicity;
- evidence that the chemical is both persistent and bioaccumulative; and
- detection of the chemical in biomonitoring or in food, drinking water, air, soil or house dust.
Some of those criteria may sound reasonably tough, but applying them to new chemicals would be problematic: A new chemical would not yet be in production and use, so obviously it wouldn’t yet be present in people or the environment. EPA would have to project whether it would later be found there. I wish I had more confidence in our track record of predicting chemical exposures, but frankly, it’s pretty dismal.
As for toxicity, while the list of types of toxicity in the provision is pretty impressive, the question is whether the minimum data to be required for a new chemical will be sufficient to determine whether it has any of them (more on minimum data requirements in a moment).
A barefaced double standard
Ironically, this provision would do – but in reverse – exactly what the industry has gone apoplectic over in other contexts. It would decide what to do about a chemical based solely on its hazard or exposure, rather than by assessing its risk.
The chemical industry staunchly opposes ever identifying “bad” chemicals via a solely hazard-based approach. And it never utters the word “biomonitoring” without hastening to add, usually in the same sentence, that mere detection of a chemical in people says absolutely nothing about its risk.
Yet here the industry is merrily endorsing giving a new chemical a free pass based solely on whether or not it meets certain decidedly non-risk-based criteria.
Last time I recall, the American Chemistry Council’s first principle for modernizing TSCA read as follows: “Chemicals should be safe for their intended use.” Just checked again, and yes, it still reads that way.
So why is the industry so willing to let new chemicals slip onto the market without a safety determination? I smell a double standard.
No data, no problem?
There is one small silver lining to the troubling provision noted above: It would at least require that the decision as to whether a new chemical meets the red-flag criteria be based on a minimum data set.
The more extreme manifestation of the stifling-of-innovation argument says that even that requirement will cause the ever-churning wheels of new chemicals development to grind to a screeching halt.
Perhaps the most vocal proponent of this viewpoint has been Charlie Auer, former Director of EPA’s Office of Pollution Prevention and Toxics (OPPT), and now a chemical industry consultant. I heard this argument from Mr. Auer firsthand at a recent conference in DC, which was reported in the April 19, 2010 issue of the Daily Environment Report (page A-11, subscription required).
He points to the draft legislation’s requirement for a minimum data set for new chemicals as evidence of a “strong bias” against new chemicals. 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 priori 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.