Nano Nano: Yesterday the EU, Today the US pushes for new use rules on nanomaterials

Yesterday I noted that the EU President had called more stringent regulation of nanomaterials, those very small versions of substances that may, or may not, present a different risk pattern than their larger cousins.  But the EU isn't alone in pursuing greater regulation.  The US EPA has now issued a Final Rule for "Significant New Uses" of several specific nanomaterials called single- and multi-walled carbon nanotubes.  As the name suggests, these materials basically look like tubes of chickenwire, which may be either single (like the photo) or have more than one layer of chickenwire tube.

The significant new use rule (or lovingly, a SNUR), may be the beginning of wider EPA rulemaking activity on nanomaterials.  While nanotubes have some particular differences from other types of nanomaterials, for example, fullerenes (also known as buckeyballs as the base form was named after Buckminster Fuller, the developer of the geodesic dome, which the fullerenes resemble in structure), the actions taken could be a steppingstone for changes in the way other nanomaterials are regulated as well.  The SNUR addresses several issues including releases to water or dust emissions of such small particles, as well as how to deal with articles such as those products made from plastic where residues or erosion of substance may lead to nanoscale releases of the base chemical. One potential problem raised is that long, thin nanoscale materials such as nanotubes may act like asbestos fibers and find their way into the furthest reaches of the lungs.  Whether that is the case or not, the concern is there and is being raised by such people as those at NIOSH.

Where this will go is still a question, but we may find out sooner rather than later as it is expected that a broader SNUR being developed by EPA will be sent to OMB for review in the next few months. 

More to come on the nanomaterial front as there are reminders from regulators and advocacy groups that everyone took the safety of GMOs for granted until a public outcry, whether justified or not, began halting development.  The goal for nanomaterials has been to develop an appropriate mechanism for assuring safety.  Though in a way it is like closing the barn door after the horses have escaped since many of the products we have been using for years already contain nanoscale materials in their composition.

EU calls for nanoscale materials listing

Nanomaterials are substances that are very very small, but they have been making very big news in recent years.  Regulatory bodies in the United States, the European Union, and other jurisdictions have been trying to figure out how to, or even whether or not to, manage materials that may be the same as materials already evaluated...except for the size.

And therein lies the problem.  Nanomaterials are so small that they may have different properties than the same substance in a larger size.  The bigger version may not be so much of a toxicology problem, for example, because the particles are too big to get into the body in sufficient amounts.  But make that same material in very small particle sizes and suddenly it can get into the lungs, the bloodstream, and even pass through cell membranes.  Or maybe not.

That uncertainty has led to the recent calls by the EU President for an increase in the public's "right-to-know" about nanomaterials in products used by consumers. The proposal includes calls for a mandatory registry of nanomaterials so that regulators and the public can see where they are being used.  He also wants to see nanomaterials noted on labels so the public can have the information they need to choose whether to use or not use.  There were also calls for member states of the EU to develop national strategies.

Is all this needed?  Many argue that it is not.  Most nanomaterials are just smaller versions of chemicals or products that already undergo regulatory review.  In theory, any review should include the form in which the material is placed on the market.  And once in an article or product, the nanomaterial acts as the article or product, not as a nanomaterial.  But then others disagree.  Nanoscale materials may have very different properties than the bulk material.  Think of a big chunk of iron versus iron powder.  Now think of iron powder versus powder so fine that you can't even see it.

So the EU has made a proposal and time will tell what member states or the EU itself will do.  Likewise the United States is struggling to determine the best way to ensure that nanomaterials are as safe as their non-nano equivalents.  But then given the debate over whether TSCA has been a sufficient regulatory vehicle to ensure safety, there is no question that nanoscale materials will be a consideration in any new path forward.

USEPA Streamlines Enforceable Consent Agreement Process

One of the ways that EPA has to collect data on chemicals is to use an "enforceable consent agreement (ECA)."  These ECAs are semi-pseudo-voluntary (sort of) agreements in which industry (more or less) consents to provide EPA with test data on their chemicals.  This saves EPA from having to go through the long, oft-times futile, process of promulgating a formal Section 4 test rule.  For industry, it gives companies a chance to negotiate the terms of the testing program, including what tests to run, what to test, and how long they have to finish the work.

But EPA and industry alike have been frustrated by the time it takes to negotiate the ECA.  So yesterday the EPA published the final rule in the Federal Register.  It not only allows EPA to set a firm deadline on when negotiations must end, but also changes how EPA can initiate the discussion.  The rule becomes effective on October 18, 2010.

The new ECA rule is just one of many steps the EPA has taken in the last two years to take full advantage of the authority it has under the Toxic Substances Control Act.  In the past EPA has been slow to push its authority, and in fact has been rather gun-shy about mobilizing resources for efforts it felt would just be for naught anyway (10 years of work to ban asbestos and then have it voided by the courts will do that to an Agency).  But times have changed, at least EPA believes they have changed.  Industry has been supportive of a modernization of TSCA, and while the legislative process on developing a new law is painstakingly slow, they seem less inclined to challenge EPA's new-found assertiveness.

Of course, the election may change that.

The "New TSCA" and POPs, PBTs, and International Chemical Treaties

This summer the House introduced a formal TSCA reform bill, following up on the "discussion draft" issued in April when the Senate introduced their version of TSCA reform.  One measure that didn't get a whole lot of press (but about which I tweeted) was how the bills dealt with the big international chemical treaties to which the US had never ratified.  Those treaties are the Stockholm Convention, the Rotterdam Convention, and the LRTAP POPs protocols.  All deal with a small list of specific chemicals that exhibit persistent, bioaccumulative, and toxic characteristics, i.e., PBT.  The variation, Persistent Organic Pollutants (POPs) have similar criteria, and then there are those chemicals that are Very Persistent and Very Bioaccumulative (vPvB), which may pose future concerns whether or not they currently meet the toxicity criterion.

The House discussion draft was pretty fuzzy as to how the new TSCA would help the US ratify the agreements, but the formal H.R. 5820 directs EPA to implement "provisions of international agreements" that are "related to chemical substances and mixtures" to which the United States becomes a party.  In fact, the House bill now looks much like that suggested back in May by CIEL, the Center for International Environmental Law.  The bill also mirrors the CIEL analysis by including a provision to regulate a newly listed chemical beyond what the treaties themselves allow.  And if the US fails to ratify the three treaties, the House bill would go ahead and ban the five chemicals listed as POPs anyway.  A bit of a nudge to get the treaties ratified.

Of course, whether these provisions survive next year's iteration of the bills is always a question.

EPA holds hearing on HPV chemical test rule

As noted a few weeks ago, EPA is working on a new proposed test rule for High Production Volume "orphan" chemicals.  The rules are authorized under Section 4 of TSCA and are designed to obtain test data that the Agency needs to better assess risk.  That was the third such rule proposed.  Well, last week EPA held a public hearing to get input on the proposed rule.  And not everyone thought testing was needed.

The sometimes odd pairing of industry and animal welfare groups again were on the same side, with industry objecting to the need to conduct some of the testing and animal welfare groups like PETA objecting because much of the testing uses animal models like rats.  Others were supportive of testing, noting that without actual data it is difficult for EPA to make sound scientific assessments of risk.

Since this is a proposed rule it will need to be finalized and published again in the Federal Register before manufacturers will be required to provide data.  EPA Chemical Control Division chief Jim Willis suggested that the final rule for this third group of HPV chemicals could be issued within 6 to 9 nine months, though he admitted that timeline was optimistic.  It seems even more optimistic when one considers that the 2nd proposed HPV orphans rule was issued in July of 2008 and to date that one still has not been finalized over two years later (though Willis did suggest it may be made final within the next month or so).

Meanwhile, EPA is working on a 4th proposed rule, though it seems it is still in the very early stages of development.  Look for that one sometime in 2011.

So while Congress sits on the proposed TSCA reform bills, EPA is trying to work within the current TSCA system.  Given that all of these test rules are for chemicals that are HPV "orphans," that is, chemicals produced in high volumes yet for which none of the manufacturers stepped forward voluntarily to provide data under the HPV Challenge program, it seems that TSCA has only limited ability to address chemical concerns in a timely fashion. 

New Polling Data Indicates Overwhelming Public Support for Chemicals Regulation

My title is cribbed from the Safer Chemicals Healthy Families (SCHF) announcement of a new poll conducted by the Mellman Group.  According to SCHF, the public opinion poll "finds overwhelming public support for reforming our out-of-date system for managing chemicals."  Furthermore, this support apparently was "regardless of political affiliation," in that "voters are much more likely to support a candidate for public office who promotes better health and safety standards for chemicals."

I haven't read the entire poll yet, but the results SCHF reports are actually somewhat surprising.  Despite the current political environment that seems to favor less government intervention, and at least according to SCHF, there is widespread concern about our exposure to chemicals:

The majority of respondents said they think the threat posed by everyday exposure to toxic chemicals is serious (73%, with 33% saying it is "very serious"). 78% said that the threat posed to children by exposure to everyday toxic chemicals is “serious.” (45% called the threat “very serious.”)

Not surprising, however, is that the poll also seems to suggest that the public looks unfavorably on the chemical industry, with 45% of the public viewing the industry in a bad light.  That pretty much is status quo for the chemical industry, who despite their stewardship efforts are often seen as the bad guys (usually when some chemical is in the news or we find out it is in the blood stream of babies).

All of this plays out in a time when it is likely nothing will happen with TSCA reform this year.  With only a handful of actual legislative days left on the calendar, and a lot of incumbents facing their most challenging reelection bids ever, Congress is in no hurry to pass a bill.  So that 74% of the public that supports stronger controls on "toxic chemicals" will have to wait until at least next year.  And with Congress likely to look a lot different when it gets sworn in next January, the fate of TSCA reform could range from a bill that is workable to no bill at all.

A PDF of the poll can be seen here or on the Safer Chemicals Healthy Families web site.

Small Chemicals Business Group Says No to New Regulations

The Society of Chemical Manufacturers and Affiliates (SOCMA) issued a call last week for Congress "to avoid imposing large, new financial burden that would threaten their businesses."  SOCMA is concerned that several pending bills, in particular "those to reform the Toxic Substances Control Act (TSCA) and another designed to tighten chemical security laws by mandating product substitution, could significantly add to the financial burden of complying with regulation."


Organizations like SOCMA serve the batch, custom and speciality chemical industry, which are mostly smaller and mid-size companies.  Unlike the bigger multinational companies, these smaller producers have fewer resources to deal with new requirements. 

Which is why the TSCA reform proposals on the table now have provisions to help small and medium sized businesses.  Whether they are enough or sufficiently balance the needs of specialty businesses with the needs of the public to know that chemicals have been demonstrated to be safe is still open to debate.  As SOCMA notes, there is a "high likelihood that the next Congress to convene early next year will look very different from this one."  And that could mean significant differences in what the final TSCA reform bills look like.

Does the BPA debate epitomize the need for reform of the TSCA chemical law?

At least one person thinks so.  Writing in the online OnEarth Magazine, Wendy Gordon believes that the seemingly endless debate over BPA - the chemical used in myriad plastic bottles and other products - is a strong signal of the need for TSCA reform.  She laments that "[a]fter more than 10 years of research involving hundreds of studies, government health officials according to The New York Times (September 6, 2010) "still cannot decide" whether the science is adequate to regulate BPA more strictly, an action the Food and Drug Administration has the authority to take but just won't, or can't...or would rather put off until after the next round of studies."

And herein lies a recurring problem with chemical regulation.  How much data are enough?  Rarely are the data so overwhelmingly clear that a particular chemical will definitely create adverse effects that the path forward is obvious to regulators, industry, and NGOs alike.  Rather, the norm is that there are some data that suggest, maybe even strongly suggest, that there are concerns.  But then the realities of decision-making come into play. What is the threshold of concern for taking action?  Should BPA, as an example, be banned outright based on the data we have?  Or should more studies be conducted to dig deeper into the specific concerns suggested by earlier studies?  These are often more value judgments than clear scientific direction.

The answer is that we don't have an answer. Each case will be different as the circumstances of hazard and exposure will be different from one chemical to another and one use pattern to another.  Which is why the debate seems to go on and on with no resolution.  Given the significant business and personal consequences of making the wrong decision - banning something that doesn't need to be or not banning something that should be - clearly a better process is required.

Will the proposed TSCA reform bills now sitting idle in the House and Senate be that better process?  It seems like it could be a moot point given the current predictions for the fall elections in the US.  No matter what happens in November the bills will have to be reintroduced in the next congress and the debate will start anew.  But the direction the bills take could be significantly affected by the make up of the two bodies of governance.

Or perhaps, as Wendy Gordon suggests, we will just see the continuation of "endless debate."

Global Warming Requires Global Action According to UN

UN Secretary-General Ban Ki-moon has called for "global leadership" and a "new way of thinking" in dealing with climate change.   Speaking at Liechtenstein's Vaduz-Saal, the UN chief emphasized the world has become a smaller place, where the activity of 7 billion humans and growing can have global impacts.  He cautioned that "We must think green, too – an ambitious climate change agreement -- and environmental governance that protects the resource basis."  His full speech can be read here.

While all parties work to protect their own interests - the wealthy countries their status of living and the poor countries their options for the future in a world for which they largely aren't responsible.  But in another sense, we are all in this together.  This planet is the only one we have, and our actions are having dramatic and long-term effects on the climate in which future generations will have to live.  We have a responsibility to be good stewards for our children and grandchildren.  How we proceed will tell them more about us than how big the wide screen TV is that we bring home.

According to Ban Ki-moon:

What I mean, quite simply, is sovereign states coming together -- pragmatically, as partners.

I mean people transcending borders and narrow national identities to defend against common threats – and to seize common opportunities.  

European Chemicals Agency Proposes More Substances of Very High Concern

The European Chemicals Agency (ECHA) in Helsinki, Finland, last week announced the addition of 11 more substances of very high concern (SVHCs) they intend to put on the REACH candidate list.  Chemicals on the candidate list could eventually end up on Annex IX of REACH, after which they could be banned or severely restricted from the market unless "authorized" for specific uses and only for limited periods of time while alternatives are developed.

Stakeholders have until October 14, 2010 to comment on the addition of the substances to the candidate list.  So far all of those proposed have been added, totally nearly 40 to date.  Commenters are asked to focus on hazards of the chemicals since that is the focus at this point.  If companies apply for Authorization then use patterns, exposure and risk will be considered in final decision-making.

The candidate list as it currently stands can be found on ECHA's web site.

States push for TSCA chemical control law reform

ECOS, the Environmental Council of the States, held its annual meeting last week and among other activities passed a resolution calling for reform of the 34-year old Toxic Substances Control Act.  ECOS is an organization of state environmental agency leaders.

According to the resolution, which can be downloaded here, ECOS supports congressional action that would place the onus on the chemical industry to prove their chemicals are safe, to give EPA sufficient authority to ensure that chemicals are safe, including the ability to do so in a timely fashion, to provide EPA with a mechanism by which they can share confidential business information they receive with the states, to require safer alternatives (substitutes), and authorize EPA to take expedited action when a chemical presents "imminent or substantial endangerment or is persistent, bioaccumulative and toxic (or very persistent and very bioaccumulative whether or not it is toxic), etc.

The states have been very active in pushing for federal legislation because otherwise they would have to undertake state-level legislation, which not only is a burden to the states but a burden to industry who could be faced with complying with 50+ different state regulations.

Given the current lack of federal action likely before the mid-term elections, the states will have to wait until next year for TSCA reform on a national level.

26 Advocacy Groups File Comments in Support of EPA Policy to Limit Confidential Business Information

Back in May 2010 the USEPA issued a "Notice of General Practice of Reviewing Confidentiality Claims for Chemical Identities in Health and Safety Studies Submitted Under the Toxic Substances Control Act (TSCA)."  Today twenty-six health, labor and environmental advocacy organizations filed a 19-page set of detailed comments "voicing resounding support for a long-overdue change" in EPA's policies.

In short, EPA will no longer accept routine claims of confidentiality for chemical names when companies submit what are called TSCA 8(e) notices, i.e., reports of significant adverse effects.  Companies are required to report immediately if they become aware of such significant effects, usually as a result of toxicity testing that indicates unexpected levels of toxicity.  These health and safety studies themselves cannot be held confidential, but the advocacy organizations argue that by withholding the name of the chemical tested the health and safety result is meaningless.  After all, the public would have no idea on what chemical the study was conducted. [EPA, of course, does know what chemical is being reported, but the portion made public may be significantly redacted to protect competitive advantage for the company, which is important for example if the chemical is being newly developed for the marketplace or a new use in the marketplace.

One of the primary advocacy organizations preparing the comments is the Environmental Defense Fund, which has played a leading role in the advocacy community when it comes to chemical safety issues.  More information on the EPA action and the 26 advocacy groups can be found on EDF's web site.

OSHA Wants You - To Help Identify Top Chemicals of Concern

The Occupational Safety and Health Act - OSHA - is looking for input from stakeholders as they seek to update and set new Permissible Exposure Limits (PELs).  Most of OSHA's PELs are old, and many wonder if the data on which they were based are sound.

PELs are "regulatory limits on the amount or concentration of a substance in the air."  They have been one of the primary mechanisms by which OSHA sets and enforces standards for "preventing occupational illnesses and injuries." 

By asking for input, OSHA is hoping to incorporate substantial advances in the science and our knowledge of chemical since PELs were first adopted decades ago. In particular there is concern that new methods of analyzing chemicals to very low levels and better understanding of more subtle effects has resulted in many of the PELs being set too high, i.e., they are no longer sufficiently protective of public health.

So, "as an initial step," OSHA wants to here from you, and me, and anyone with input so that they can identify the chemicals of most concern.  OSHA recommends that "when nominating a particular chemical, please include the criteria you used for selecting that chemical for nomination (e.g., the OSHA PEL is inadequate, there is widespread use of the chemical and potential worker exposure)."

OSHA has provided an online form for nominations and criteria of chemicals of concern.

EPA to Issue HPV Chemical Test Rule; Hold Public Meeting

EPA is preparing to issue a new HPV test rule.  This will be the third (or possibly fourth) such rule, though only one of them has ever gone final.  The test rules, issued under the authority of TSCA Section 4, are designed to require testing of chemicals that are "orphans" of the High Production Volume Chemical Challenge Program.  These lost orphan chemicals are one reason why TSCA reform is needed.

So what is an orphan?  When the HPV Challenge program started in 1998, with much fanfare as then Vice-President Al Gore made the Earth Day announcement, there were high hopes that industry would voluntarily provide data on about 2800 of the highest production volume chemicals in the US.  The program had some caveats to it, which I won't rehash here, but by the (extended) 2005 completion date only about half of the chemicals had full data packages submitted.  Five years later that number has barely moved.  And that doesn't even count all the chemicals that have become HPV since the initial program list was written in stone.  It also doesn't include several hundred chemicals for which no one even bothered to volunteer data.  These are the "orphan" chemicals.

EPA has been trying to require testing for these nearly 300 unsponsored "orphan" chemicals.  They have gone through the iterative process of identifying the need, establishing the regulatory authority, and publishing "Proposed Test Rules" in the Federal Register.  Following comment periods these rules should be finalized and the required testing begun by the manufacturers.  In reality the proposed rules have languished unfinalized for a very long time, the earlier ones measured in years.  Only one has become final.

Today the EPA is supposed to announce an open meeting to be held on September 9th to listen to comments from interested parties, including the general public, the manufacturers and downstream users, and various health and environmental advocacy groups.  Here is the link to the meeting announcement.  Still, one has to wonder whether this is just another baby step to nowhere.  The elections are still a little over 2 months away, and Congress is hunkered down in reelection mode with no energy or desire to do any legislating.  Meanwhile, stakeholders in industry and the advocacy communities appear to have gone into bunker mode in an attempt to protect their individual objectives.  So whether this action means much is anyone's guess.