ECHA to use its "discretionary right" to support REACH chemical registrants that can't meet the November 30th deadline

Well, within limits.  As the November 30, 2010 deadline rapidly approaches, the European Chemicals Agency (ECHA) is anticipating that at least some (or perhaps many) companies will be unable to complete their REACH registration packages for REACH by the time.  In a September 27th press release, ECHA says:

Companies facing exceptional situations that are likely to prevent them from registering on time should inform ECHA well ahead of the deadline of 30 November 2010.

However, this support will only be available in "exceptional cases," specifically under five scenarios:

• Difficulties to provide data required in Annex VII and Annex VIII in due time or difficulties for importers of mixtures to obtain compositional and analytical data of the substances in the mixture from their suppliers (Issue No. 10)
• Impossibility of transferring pre-registrations or submitting a late pre-registration due to legal entity changes (Issue No. 15)
• Failure by the lead registrant to submit a fully REACH compliant dossier (Issue No. 20)
• Downstream users are obliged to become importers, as a substance is not registered by any EU based supplier (Issue No. 21)
• Registrants need to accommodate new/updated guidance and hence have difficulties to provide data in Annex VII and Annex VIII in due time (Issue No. 10)   

51 investor organizations sign letter urging Congress to act on TSCA safe chemicals reform

Normally we hear about environmental and health advocacy groups supporting safe chemical legislation.  Yesterday 51 organizations focused on managing billions of dollars in assets endorsed the recent Safe Chemicals Act (introduced in the Senate) and the Toxic Chemicals Safety Act (introduced in the House).

They argue that taking action to ensure the safety of chemicals is not only good for business, it is essential for business because“exposures to toxic chemicals produce a tremendous drag on the U.S. economy, contributing to health problems throughout supply chains.” 

 
They go on to note that:

"chemical exposures have been linked by scientists to various forms of cancer, learning and developmental disabilities, Alzheimer’s and Parkinson’s diseases, reproductive health and fertility problems, and asthma. Savings in health care costs from reducing exposures vary among studies, but routinely add up to billions of dollars annually. Exposures lower worker productivity and raise corporate health care costs. These can burden corporate performance and reduce investor returns."

The investors further encourage action, and the goal “should be to move American business swiftly away from 20th Century chemistry, with its legacy of Superfund sites, impaired human health, and damaged ecosystems, to green 21st Century chemistry that will better serve the long term well-being of business, humanity, and Planet Earth.”

The press release can be seen at the Investor Environmental Health Network web site.

OECD issues report on the safety of nanotechnology

As I have reported in the past, there is a lot of interest by various regulatory and government bodies in trying to come up with the best way to ensure the safety of nanoscale materials in the market place.  The newest is a report issued by the Organization for Economic Cooperation and Development (OECD).

The report is available as a PDF document here.

Specifically the document "provides information on current/planned activities related to the safety of manufactured nanomaterials in OECD member and non-member countries that attended at the 7th meeting of OECD’s Working Party on Manufactured Nanomaterials (Paris France, 7-9 July 2010)."  It also includes "written reports on relevant current activities in other International Organisations such as the ISO and the WHO."

The WHO (not the rock group) is the World Health Organization.  ISO is the International Organization for Standardization. Also contributing is the Food and Agriculture Organization (FAO; governments and scientists just love acronyms).

OECD's activities on nanotechnology are coordinated through "The Working Party on Manufactured Nanomaterials," which "brings together more than 100 experts from governments and other stakeholders"

According to the OECD report "The Working Party is implementing its work through specific projects to further develop appropriate methods and strategies to help ensure human health and environmental safety:

• OECD Database on Manufactured Nanomaterials to Inform and Analyse EHS Research Activities;

• Safety Testing of a Representative Set of Manufactured Nanomaterials;

• Manufactured Nanomaterials and Test Guidelines;

• Co-operation on Voluntary Schemes and Regulatory Programmes;

• Co-operation on Risk Assessment;

• The role of Alternative Methods in Nanotoxicology;

• Exposure Measurement and Exposure Mitigation; and

• Co-operation on Environmentally Sustainable Use of Nanotechnology

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.