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

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

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