EU to the Rescue? Regulating Toxic Chemicals

Throughout my professional life, I have, for the most part buried my head in research. That’s what it’s all about - the science - right? Wrong. Not when it comes to toxic chemicals. Back when I was in graduate school, there were some hints that other things, like regulation and risk assessment were important – but I couldn’t be bothered. Even as Sheila Jasanoff, who boggled me with her intelligence and eloquence, led us graduate students through the morass of legalese in her Toxic Torts class, I just didn’t get it. Why laws were written so unintelligibly I could never understand, except maybe to help employ more lawyers.

So twenty years later – maybe even to the semester that I earned the only “C” in my post-secondary career (well – I also pulled off a C in History of the World a well known “gut,” freshman year of college), I am struggling to understand why our country’s Toxic Substances Control Act, the legislation designed to protect us from harmful effects of toxics does not; and why Europe’s new chemical control policy promises so much more.

Thankfully I’m not the only one trying to figure this out. This summer the General Accountability Office or GAO released a report comparing TSCA with Europe’s new Registration, Evaluation, and Authorization of Chemicals (REACH) legislation. Noting one primary difference between the two, the GAO states:

“TSCA places the burden of proof on EPA to demonstrate that a chemical poses a risk to human health or the environment before EPA can regulate its production or use, while REACH generally places a burden on chemical companies to ensure that chemicals do not pose such risks …….” (emphasis added)

You don’t have to be a toxicologist to know how difficult it is to determine that any one particular chemical poses a risk, you just have to read the papers. He says this, she says that, and meanwhile, polybrominated fire-retardants contaminate the dust in our homes, bisphenol-A leaches from baby bottles, and we’re wondering how the gasoline additive MTBE, which now contaminates groundwater across the country could ever have been allowed. But now the EU is requesting that industry take the lead ensuring (as best they can) that a chemical poses little risk to human health and the environment before setting it loose.

Then there are the tens of thousands of chemicals that were on the market prior to the 1980 enactment of TSCA. Unless there was reason for suspicion, those were grandfathered into chemical complacency. And into our food, clothing, air and water.

Unlike TSCA, REACH does not distinguish between new chemicals or old chemicals, according to a recent article in Environmental Health Perspectives REACH will require safety and exposure data on something like 30,000 chemicals currently sold in Europe. Those chemicals that are “carcinogenic, mutagenic, persistent or bioaccumulative or toxic to reproduction” will receive special attention. I just hope the EU has armies of toxicologists lined up to review this stuff!

Many times I’ve harped on how we seem to make the same mistakes over and over again. But it seems the EU has finally looked back before moving forward. When in class, I try to make it clear that being toxic isn’t enough to raise the reputation of a chemical to celebrity status. Exposure matters. How and how much we are exposed to certain chemicals is key. Sometimes exposure takes us by surprise. Who knew that polybrominated fire-retardents would shake free from their products (although one would think that their similarity to PCBs and dioxins might have raised some concern early on about their tendency to bioaccumulate), or that bisphenol-A would leach into water and food to the extent that it does, or that MBTE would wend its way around soil particles into our water, leaving other fuel components behind to be degraded? To address exposure – the EU proposes to consider all uses of a chemical – and to inform all “downstream uses,” clothing, cosmetic, packaging manufacturers for example, of not only the chemical’s properties but also how it behaves in humans and in the environment.

This kind of information, according to Joel Tickner, from the Lowell Center for Sustainable Development, (as reported by EHP), may drive innovation towards less toxic, safer products. According to EHP, “[Tickner] says there is a clear interest of downstream users of chemicals who want the functionality of the chemical but not their toxicity. Companies in sectors such as health care, footwear, electronics, and cleaning chemicals have already started to demand these products from suppliers.”

Amen. And with some trickle down – U.S. companies wishing to supply E.U. with chemicals will have to comply with REACH – there’s hope that we can clean up our act here at home.

A nanometer of regulation: EPA, TSCA and nanomaterials

I just came across a little blurb in this week’s issue of Science, noting that the EPA has finally made some decisions about regulating nanomaterials. A quick read indicates that 1) the EPA has decided that for chemicals already registered under their TSCA Chemical Substance Inventory (TSCA is the law enacted to protect us humans and the environment from nasty chemicals – and the inventory is a listing of all those chemicals from which we’re being protected) – nano-formulations of those chemicals will not require new registration (or registration as a new chemical) and 2) they are asking for voluntary submission of health and toxicity data, by manufacturers and users of nanomatierals. Huh.

So what does this mean? I was confused when I first read it. After reading and writing about nanomaterials, I thought one of the advantages of producing these things were specifically (in some cases) because they act differently than their bigger, larger, brothers and sisters. For example compounds like titanium dioxide and zinc oxide were nanoized in the first place was to take advantage of the differences between the larger forms and the smaller. So, I though, maybe the EPA didn’t really mean that.

Fortunately, EPA has an easily readable paper that explains these things – like how they define a new chemical - in great detail. According to their TSCA Inventory Status of Nanoscale Substances – General Approach (2008) paper, EPA focuses on “molecular identity.” In this case, chemicals that have the same molecular formulas, the same crystal structures, the same spatial arrangement of atoms – are the same chemical. That means, according to the EPA, and to borrow from Dr. Suess, titanium dioxide is titatinium dioxide no matter how small.

Why is it important to distinguish a chemical as “new?”

Normally, when a company manufactures a “new chemical,” unless it’s exempt – the company must submit a Pre-manufacture Notice, which then triggers some basic testing. That little bit about “exempt” can be important. In fact, you’ve likely got some of those “exempt” chemicals floating around in you right now. Remember all the hubbub about PFOA and PFOS? Those chemicals in Gore-Tex and Teflon and other products? Well perfluorinated chemicals involved in the production of PFOA and PFOS were granted exemptions, in this case because they were in commerce before TSCA came along. But look what happened. Now we’ve got those chemicals contaminating wildlife around the world. To be fair, it’s possible that would have happened anyway – who knows. But here’s the catch, the exemption was granted with the understanding that under TSCA, should any manufacturer realize that there might be health and safety issues, such information “ [would] be submitted to the Agency…when companies learn of it.” In the case of these products this didn’t happen, and Dupont ended up settling that account for $10 million dollars.

A steep price to pay; and an example which hopefully demonstrates for manufacturers that honesty really is the least expensive policy.

There are various ways a chemical might be exempt. If it’s used only for research and development, it might be exempt. If it’s produced in low volume, it might be exempt. And, if there’s some indication that it would be released in only small concentrations or that there would only be small exposures, it might be exempt.

Bottom line? There will be nanomaterials that will not be required to undergo testing.

Ah but rest assured, EPA has considered that some of these exempt or untested chemicals may have adverse health or environmental effects. You see, they recently announced their Nanoscale Materials Stewardship Program, where according to the program description, “Participants are invited to voluntarily report available information on the engineered nanoscale materials they manufacture, import, process or use,” should they happen to observe anything funky happening with their materials.

Let’s hope they do.

For a good readable explanation of TSCA and how it may or may not apply to nanomaterials check out the article “TSCA and Engineered Nanoscale Subtances,” by Lynn L. Bergeson and Ira Dassa and published in Sustainable Development Law and Policy.

Controlling Toxics?

While researching regulation and toxicology of nanomaterials for a post on this page, I was directed towards the following report produced by Environmental Defense: “Toxic Ignorance: The continuing absence of basic health testing for top-selling chemicals in the United States.”

Interesting reading which discusses the gaps in the U.S. EPA’s Toxic Substances Control Act (TSCA). According to the EPA, TSCA was “enacted by Congress to give EPA the ability to track the 75,000 industrial chemicals currently produced or imported into the United States. EPA repeatedly screens these chemicals and can require reporting or testing of those that may pose an environmental or human-health hazard. EPA can ban the manufacture and import of those chemicals that pose an unreasonable risk.”

Environmental Defense’s 1997 report suggests that sufficient human health and environmental toxicity data exists for only a relatively small percentage of chemicals, (even those produced in high volume). More recently Environmental Defense points to recent progress by EPA and industry towards addressing data gaps.