Europe Adopts First Chemicals for its Authorization List under REACH

We now have our first list of chemicals added to Annex XIV for possible Authorization.  This past week the EU’s REACH Committee adopted a list of six substances the European Chemical's Agency (ECHA) has proposed as substances of very high concern.

The six listed in Annex XIV are:

• 5-tert-butyl-2,4,6-trinitro-m-xylene (also known as musk xylene)
• 4,4’ – diaminodiphenylmethane (MDA)
• Hexabromocyclododecane (HBCDD)
• Bis(2-ethylhexyl)phthalate (DEHP)
• Benzyl butyl phthalate (BBP)
• Dibutyl phthalate (DBP)

All six were previously listed on ECHA's "candidate list," which is the first step in the REACH Authorization process.  Following the opportunity for stakeholders to comment, the chemicals now are formerly added to Annex XIV of REACH. 

And here is where things get really interesting.  Now that these six (and many more in the future) are in Annex XIV, they are now considered to be on the chopping block.  These six chemicals will be banned after a designated time period unless manufacturers make formal application for "authorization."  Authorization means they could be allowed to continue certain uses of the substance, but only under strictly controlled conditions for a finite period of time to allow the development or discovery of a substitute substance.  Meanwhile the stigma of being listed will likely cause downstream users to search for alternative formulations for their products, so the incentives for finding replacements are based both on regulatory deadlines and market economics.

New book attacks the chemical industry as "The Polluters"

A new book by Benjamin Ross and Steven Amter apparently pulls no punches in attacking the chemical industry for lobbying to inhibit regulations of toxic substances.  I have not read this book, so for more information please see the Washington Post book review by Seth Shulman.  The title is "The Polluters: The Making of Our Chemically Altered Environment" and is available at Amazon.com.

Based on the review, it appears to be reminiscent of two other recent books, "Doubt is Their Product: How Industry's Assault on Science Threatens your Health" (by David Michaels), and "Merchants of Doubt: How a Handful of Scientists Obscured the Truth on Issues from Tobacco Smoke to Global Warming" by Naomi Oreskes and Erik M. Conway.  Both borrow the famous phrase from a former tobacco executive for their titles, and both accuse various industry's trade associations and individual companies of hiding the truth to protect corporate profits.

The Shulman review includes the following regarding the industry's lobbying role:

Some parts of the story are wrenchingly familiar. Just as tobacco executives twisted the science and strove to manufacture uncertainty about the dangers of their products even when fully aware of them, so did the chemical industry undertake a similar campaign through its main lobbying arm, the Manufacturing Chemists Association (now the Chemical Manufacturers Association).

It's unclear whether Mr. Shulman wrote that or if it is extracted from the book, but the Chemical Manufacturers Association is no longer in existence, at least by that name, as it has been called the American Chemistry Council for the last 10 years.  Hopefully the rest of the book is more up to date.

In any case, the book's authors are scheduled to appear at the National Book Festival being held on the Smithsonian Mall on Saturday, September 25th.

OMB Watch Says DOI Policy Inadequate to Protect Scientific Integrity

OMB Watch, a watchdog organization focusing on scrutinizing Office of Management and Budget activities, has given support to comments filed criticizing the Department of Interior's proposed scientific integrity policy.  The policy is in response to the March 2009 memo from President Obama establishing six principles for scientific integrity.  OMB Watch joins comments filed by the Union of Concerned Scientists and other public interest and environmental groups in saying that the policy "fails to address the full range of threats to scientific integrity at DOI, such as those evidenced by abuses at the former Minerals Management Service."

The commenters do agree that the proposed policy "does take steps to prevent misconduct by scientists."  But they charge that it "fails to protect scientist whistleblowers" and "does little to improve either the transparency of scientific activities or the ways that scientific information is used in decision making."  They further state that the proposed policy effectively "does nothing to prevent political interference with science."

OMB Watch and the Union of Concerned Scientists provide comments that discuss three areas where reforms are needed: 1) protecting government scientists, 2) making government more transparent, and 3) gathering scientific information and advice.  More information can be found at OMB Watch, the comments themselves, and the web site of the Union of Concerned Scientists.

Recommedations are more than a year overdue.

European Chemicals Agency Expects "Millions" of Classification and Labeling Notifications

Manufacturers and importers of chemicals in Europe have been pretty busy lately finalizing their extensive registration packages for REACH.  At least those that must meet the November 30, 2010 registration deadline for high production volume and substances of very high concern.  But the European Chemicals Agency is reminding everyone not to forget another looming deadline - notification under the regulation on Classification, Labelling and Packaging (CLP).

With the first deadline for notifications being January 3, 2011, just one month after the first REACH registrations are due, ECHA is concerned that companies will forget about this other obligation.  The CLP regulation requires "all chemical companies operating in the EU market...to classify and label their hazardous substances according to the CLP rules."  All notifications go into a central inventory database maintained by ECHA.  And ECHA is estimating that there will be millions (yes, millions) of notifications, which includes information on hazard that will go onto labels of substances and mixtures.  Also included are a standard set of "pictograms, signal words, hazard statements and precautionary statements" that will "allow manufacturers, importers, downstream users and distributors to easily share information on the hazards of substances and mixtures."

 More information on the CLP requirements and how to notify ECHA can be found on ECHA's CLP page.  Click on the listings in the left hand column for specific guidance and time lines.

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.