Obama Administration Revisits Scientific Integrity Policy

Over a year and a half ago I reported on the Obama Admininstration's call for Agencies to develop scientific integrity rules, and even asked for the public's input. The main activist group representing government scientists also called for a formal policy.  Just last week I noted that the Department of Interior has finally issued their rules, though OMBWatch, the Office of Management and Budget watchdog organization, felt they didn't go far enough. Now the National Commission set up earlier this year to monitor and evaluate the response to the BP Deepwater Horizon oil catastrophe in the Gulf of Mexico has come out to say that the White House could have done a better job.

So where is the Administration on developing these guidelines, and why is it taking so long?

Remember that the rationale for developing scientific integrity rules in the first place was because there were so many complaints about how the Bush Administration had suppressed science that conflicted with its political goals.  As Francesca Grifo from the Union of Concerned Scientists says in a recent edition of "All Things Considered" on NPR: 

The point is that you don't want to have political appointees using science as a cover and changing the science so that it appears that what they're doing is science-based when it's not. And that's certainly what we had eight years of. And we really were hoping, with this administration, that that was not what we're going to see. 

The problem seems to be one of the trials of getting new policies through the federal bureaucracy, including the OMB, and the fact that this administrations agenda has been been quite full during the first 21 months, as opposed to any attempt to suppress science.  But clearly the administration needs to step up the pace and ensure policies are in place.  According to John Holdren, Obama's "science czar," (again, from the NPR transcript) they expect to have guidelines in place by December.  Holdren also says that "the administration is already living by the principles of scientific integrity. But he adds, even when the guidelines are finally published, putting them in practice will be a challenge."

The full recording of the NPR discussion and a transcript can be found here.

Controversial Wind Farm Off Coast of Nantucket Receives Lease

The much contentious Cape Wind project in Nantucket Sound is moving forward.  The Department of Interior approved a lease for a commercial wind farm on the Outer Continental Shelf to Cape Wind Associates for its controversial 130-turbine project off of Nantucket Sound.  This marks the first commercial lease for a major wind energy project granted by the department, but Interior Secretary Ken Salazar said officials plan to “work with a consortium of states” to expedite the permitting process for more projects.

More information on the lease and the project can be found at the Cape Wind web site.

EPA Reviews Hexavalent Chromium Toxicity

Last week the USEPA announced the availability of an "external review draft" of their Toxicological Review of  Hexavalent Chromium.  EPA is conducting a peer review of the scientific basis supporting the human health hazard and dose-response assessment of hexavalent chromium, also called "chromium VI" or simply "Cr(VI)," so that it can be posted on EPA's Integrated Risk Information System (IRIS) database.  While the water insoluble forms of chromium (e.g., chromium(III)) and chromium metal are not considered a health hazard, the toxicity and carcinogenic properties of chromium(VI) have been known for a long time.

Primarily the concern is related to chronic exposure to hexavalent chromium via ingestion. But EPA also looked at how much "the general population may be exposed to chromium by inhaling ambient air, and ingesting food and drinking water containing chromium."  EPA also says that "dermal exposure to chromium can occur from skin contact with certain consumer products or soils that contain chromium."

The deadline for comments is November 29, 2010.

Industry representatives indicate that while they support "a comprehensive risk assessment," they wonder "why EPA feels it is necessary to act now, rather than wait to review the Cr(VI) studies underway."  These additional studies are expected to be completed in early 2011.


A PDF of the Draft Toxicological Review can be downloaded on the EPA web site.

While Congress Waffles on TSCA, the White House Pushes for Ratification of International Chemicals Treaties

I have talked before about the three international treaties of which the United States originally signed on for but for which Congress has yet to ratify.  And it's been a while, folks.  So while Congress busily punts on TSCA reform at least until next year, the Obama White House has decided to push for ratification.

And the White House's point person in the Senate is none other than Frank Lautenberg, the New Jersey Democrat who has spearheaded the effort to introduce (and reintroduce...and reintroduce) the ever evolving [Kid] Safe Chemical Act. 

The main reason to ratify the three treaties - Stockholm Convention on POPs, Rotterdam Convention on Prior Informed Consent, and Long Range Transboundary Air Pollution POPs Protocol - is because we don't have a seat at the table.  Okay, that's not quite right.  We have an "observer" seat at the table, and representatives can be quite vocal in pressing their point.  But when it comes time to vote the US has to sit back and let everyone else decide what happens to us.  We're not powerless, but we're also not as persuasive as we could be if they have to take our vote into consideration.

Unfortunately, or fortunately depending on your point of view, ratification of these treaties will likely also go nowhere until after the election, and then the new Congress (perhaps, very new Congress) may have a different take on the political versus scientific advantages of active participation that ratification would provide.

Is TSCA chemical reform good for business?

It depends on who you ask.

If you ask the major NGOs, the answer is yes, of course it is good for business.  To begin with, TSCA reform would help protect both workers and the public from exposure to hazardous chemicals.  Safety is hard to prove as of now because for most chemicals there are very little actual health and safety data.  Reform would provide the data needed to more accurately assess risk.  Ensuring that all chemicals have data will also allow the public to gain more confidence that the system is protecting them.  While most people don't think about it all that often, any time there is a "chemical scare," either real or imagined, the public loses confidence in both the chemical industry and the regulatory apparatus.  And finally, TSCA reform would stimulate innovation as it would encourage the development of newer, greener chemicals.

The chemical industry is split on this point.  The manufacturing trade associations, especially those representing smaller and more specialty manufacturers, believe that increased regulatory burden is just too much for them to handle and that this will effect jobs.  Larger manufacturers tend to advocate both for and against positions, depending on the audience.  Greater requirements to provide data will obviously require more resources put toward testing and/or development of alternative data.  On the other hand, many manufacturers, especially those multinationals who do business in Europe, would already have had to develop those data to comply with the EU REACH program.  So they may find it a competitive advantage to "raise the bar" on US data requirements.  In any case they most likely have collaborations with more innovative firms to develop the next wave of more sustainable chemistries.

Behind all of this, of course, is the need for ensuring public health and safety and protection of the environment.

EPA Celebrates 20th Anniversary of the Pollution Protection Act

You read about it in the papers, right?  Probably not.  In any case the USEPA celebrated the 20th anniversary of the Pollution Prevention Act of 1990 last week during, not surprisingly, National Pollution Prevention Week.  The goal of the Act, affectionately called P2 (for Pollution prevention) "is reducing or eliminating waste at the source by modifying production processes, promoting the use of non-toxic or less-toxic substances, implementing conservation techniques, and re-using materials rather than putting them into the waste stream."

Doesn't sound too sexy, but P2 has "served as the foundation for efforts that have significantly reduced pollution at its source -- helping to protect children and families from the risks of exposure to pollutants, as well as reducing the amount of pollutants released into the environment."  So last week the EPA reminded people of the "the success of EPA programs such as Energy Star, WaterSense, EPEAT and DfE, which have collectively helped save billions of dollars, preserve precious resources, reduce waste and the use of toxic chemicals, and protect public and environmental health."

By the way, the "DfE" in the above paragraph stands for "Design for the Environment," and is just one of the programs in which EPA has been working with manufacturers, formulators, and downstream users to find better, more environmentally friendly ways to accomplish the same goals.  I'll do a program review of DfE at some point in the future.

As President Obama notes in his P2 message,

“Together, we can work to create a cleaner, safer world for our children and grandchildren to inherit.”

More information P2 can be found on the EPA web site.

Department of Interior issues policy on scientific integrity

The US Department of the Interior, led by Secretary Ken Salazar, has finally issued a new policy to ensure scientific integrity.  According to the "Secretary's Order," the policy is designed to "guide and ensure the integrity of science and scientific products developed and used by the [DOI] in decision making and in the creation of policy related to the conservation and responsible development of our Nation's natural resources, protecting our heritage, and honoring native cultures and tribal communities."

The policy is in line with President Obama's call last year for all agencies and departments to establish a means by which they could ensure scientific integrity.  One of the main rationales for calling for policies was the numerous accusations of suppression or manipulation of scientific data in previous administrations, most notably those regarding protection of endangered species and climate change.

While the Union of Concerned Scientists praises the DOI policy as "a great first step," the watchdog organization OMB Watch suggests it doesn't go far enough.  As the representative from UCS says,

“While this is a great framework, the real work begins now. Without specifics and a timeline, these principles will end up as just another good idea. There are many details the plan must address, including deadlines for releasing information and disclosing meetings with special interests. Interior must move quickly to put flesh on these bones."

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.