A bit of a wonky blog I’m afraid, but having seen relatively little on the recently introduced Safe Chemicals Act of 2010 and its relevance to engineered nanomaterials on the web, I thought I would post something short and sweet here.
Just over a week ago, Senator Lautenberg introduced a bill in the US Senate aimed at a long-overdue reform of toxic substances regulation in the United States – the Safe Chemicals Act of 2010. At the same time, Congressmen Rush and Waxman released a discussion draft in the House – The Toxic Chemicals Safety Act of 2010 – covering much of the same ground. Both documents aim to update substantially the Toxic Substances Control Act, or TSCA – which has been the mainstay of US chemicals regulation since 1976.
Both the 169-page Safe Chemicals Act of 2010 and the slightly shorter 119 page long Toxic Chemicals Safety Act of 2010 aim to bring US chemicals safety regulation into the 21st century. Richard Denison at EDF has already posted a comprehensive overview of proposed changes to the regulation that I would recommend reading if you are into this stuff. But here, I thought I would highlight what the proposed changes mean for the engineered nanomaterials – a class of substances that have been a bit of a thorn in TSCA’s side for the past few years.
The problem with TSCA (the old version) is that it is built on a chemicals world-view – substances are regulated based on their unique “molecular identity” – how they are described as chemicals. This works well for substances that do what they do because of their chemistry. But it runs into problems where something behaves in a certain way because of its physical form, as well as its chemical makeup. In other words, where you have stuff that is more harmful that molecular identity would suggest because of how the constituent atoms and molecules are put together, you have a problem.
There are workarounds to this within TSCA – a new substance that is chemically identical to an existing one can be regulated under the “Significant New Use Rule” for instance – but it’s a bit of a bootstrap. And with the emergence of an increasing number of engineered nanomaterials where functionality – and possibly toxicity – depend on physical form as well as molecular identity, this bootstrap has been stretched to breaking point.
So there’s been considerable interest in how the new-look TSCA will handle this.
Fortunately, things are looking good at this stage. The Senate bill has language that is in effect a substance “get out of jail free” card for EPA. Section 4 of the bill proposes amending section 3(2) of the original Toxic Substances Control Act with
“Notwithstanding molecular identity, the Administrator may determine, under section 5(a)(6), that a variant of a chemical substance is a new chemical substance.” (page 6)
In other words, EPA can decide when something with the same molecular identity as an existing substance should be treated as a new substance.
And the determiners of when this is justified? The bill proposes that section 3(13) of the 1976 TSCA act is amended with
“(C) SPECIAL SUBSTANCE CHARACTERISTICS.—The term ‘special substance characteristics’ means, such physical, chemical, or biological characteristics, other than molecular identity, that the Administrator determines, by order or rule, may significantly affect the risks posed by substances exhibiting those characteristics. In determining the existence of special substance characteristics, the Administrator may consider—
(A) size or size distribution;
(B) shape and surface structure;
(C) reactivity; and
(D) any other properties that may significantly affect the risks posed.” (page 13)
In other words, the new bill allows many of the characteristics that potentially lead to engineered nanomaterials presenting novel risks to trigger them being treated as new substances.
The House draft document is a little more explicit. It recommend amending section 3(2) of the original act with:
“(C) For purposes of this Act, such term may include more than 1 form of a substance with a particular molecular identity as described in sub-paragraph (A) if the Administrator has determined such forms to be different substances, based on variations in the substance characteristics. New forms of existing chemical substances so determined shall be considered new chemical substances.” (page 6)
with the clarification that
“The term ‘substance characteristic’ means, with respect to a particular chemical substance, the physical and chemical characteristics that may vary for such substance, and whose variation may bear on the toxicological properties of the chemical substance, including—
(A) chemical structure and composition
(B) size or size distribution
(C) shape
(D) surface structure
(E) reactivity; and
(F) other characteristics and properties that may bear on toxicological properties” (page 11)
Both the Senate bill and the House discussion document provide EPA with the authority to regulate any substance that presents a new or previously unrecognized risk to human health as a new substance. This is critical to ensuring the safety of engineered nanomaterials, where risk may depend on more than just the chemistry of the substance. But it also creates a framework for regulating any new material that presents a potential risk – whether it is a new chemical, a relatively simple nanomaterial, a more complex nanomaterial – possibly one that changes behavior in response to its environment, or a novel material that has yet to be invented. In other words, these provisions effectively future-proof the new regulation.
Of course there’s a long way to go yet. The final details of the new legislation have to be hashed out between the Senate and the House before they are finally signed off on. Then the process of interpreting and enacting the new regs starts – including working out how exactly to determine when something should be considered new for regulatory purposes.
But at least things seem on the right track as far as enabling the safe development and use of engineered nanomaterials goes.
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The two documents can been downloaded here:
The Safe Chemicals Act of 2010 (US Senate)
The Toxic Chemicals Safety Act of 2010 (US House of Representatives)
Hi Andrew,
I was just wondering why they are producing two bills ? And what will happen next. Will the two bills merge into one ?
Thanks
Vincent
Why do things the easy way when you can do it the hard way? 🙂 The procedure for new legislation in the US is that both the Senate and the House of Representatives come up with their versions of a bill first, then they try and hash out major differences in revisions. A single bill finally emerges from the Conference Committee – accompanied by a mountain of notes explaining what it means, and how differences were resolved. More detail than you ever wanted on Wikipedia: http://en.wikipedia.org/wiki/United_States_congressional_conference_committee
Thanks for the answer and for the link !
Andrew,
Dr. Heindel, Health Service Administrator, NIEHS, gave an interesting presentation last week at the FDLI Conference in DC about recent endocrine disrupter research. He indicated that research in this area has resulted in “a paradigm shift in toxicology,” specifically with respect to epigenetics. For example, whereas before NIEHS had assumed that “toxicants act individually to cause effects,” now they realized that “everyone is exposed to [toxicant] mixtures and chemical mixtures can have effects when the individual chemicals do not.” I understand that the proposed TSCA reform addresses engineered ‘mixtures,’ but does the reform fully address situations where multiple chemicals at low doses with no individual effect gang up (so to speak) and cause a cumulative effect?
Matthew
Goodness me, you don’t like to ask easy ones do you Matthew!
Mixtures have always been a complex and largely overlooked problem, but epigenetics research seems to be stirring things up here – showing that cause and effect may be more complicated than we ever thought! The draft TSCA reform legislation does address mixtures, but I must confess I didn’t read it with an eye to teasing out how far this aspect of it goes. I’ll go back and have a look at what it says…
The new documents make a real progress with respect to the introduction of the nanomaterials in the regulation. It seems also that the USA are copying the new european framework (the REACh regulation) in asking the producer of a substance to demonstrate that the substance is safe. This is also a good point because the regulation agencies don’t have the funding and the time to verify that all compounds are safe based on the information the producer has to provide through the Premanufacture Notice. Of course, there is still a lot to do in order to define precise rules in order to define if a compound is new in the regulation proposed.
Another question seems even more important to me: how will the producers demonstrate that the nanomaterial they developped is safe knowing the poor scientific data existing on the matter? The regulation seems logical in order to assess the safety of the nanomaterials effectively. But it seems to me that it will be a huge issue for the companies to fulfill the requierements in the next years, which can also strongly compromize the development of the nanomaterials. How do you see the evolution of the situation if the new regulation is adopted soon? How much time should be given to the producers to adapt? Shouldn’t the new regulation be accompanied with a much stronger financing of the EHS research issues through the NNI ?
In a simpler way : Will this good new regulation cause more harm than good for the nano-field, at least for the next 5-10 years ?