ECHA Issues New Substance Evaluation Criteria for REACH Chemical Assessments

The European Chemicals Agency (ECHA) has issued "selection criteria" for substance evaluation under the REACH program.  These criteria will be used by ECHA and the Members States to identify candidate substances for the first Community Rolling Action Plan (now called CoRAP after someone pointed out the inadequacy of its original acronym, CRAP).

According to ECHA:

Substance evaluation aims to clarify whether a given substance constitutes a risk to human health or the environment in cases where insufficient information is available. Substance evaluation will be conducted only in relation to a selected number of substances which will be chosen according to risk-based criteria. The prioritisation criteria cover hazard information, exposure information and tonnage of substances including the aggregated tonnage from the registrations submitted by several registrants. The first set of criteria is adopted by ECHA according to Executive Director's decision taken on 26 May 2011. ECHA and the Member States are using these criteria to identify possible substances that may be listed on the CoRAP and evaluated by Member States. In addition to this the Member States can also propose substances to be prioritised at any time on other risk-based grounds too. In the future, this first set of criteria will be further refined by ECHA in cooperation with the Member States.

The criteria identified by ECHA include the following:

Hazard related selection criteria:

• Suspected PBTs, vPvBs, and PBT-like substances
• Known PBTs/vPvBs
• Suspected endocrine disruptors
• Suspected CMRs
• Known CMRs
• Suspected sensitizers
• Known sensitizers

Exposure related selection criteria:

• Wide dispersive use
• Number of sites of use
• Pattern and amount of releases/exposure
• Number and type of reported uses and exposure scenarios
• Incorporation into mixtures or articles used by the public
• Potential size of the exposed population
• Number of using sites if emission is due to industrial use
• Consumer use and exposure of sensitive subpopulations such as children
• Aggregated tonnage

Risk related selection criteria:

• The risk assessment in the chemical safety report shows the risk characterization ratio is not well below 1 for human and/or environmental exposure
• Cumulative exposure from related substances with critical hazardous properties

More information on the criteria can be downloaded as a PDF file here.

Actress Jessica Alba joins Senator Lautenberg to Support TSCA Reform

Who knew Senator Frank Lautenberg could attract Hollywood actresses to support chemical law reform.  But this week that is exactly what the 87 year old New Jersey Senator did on May 24th, 2011.  He even posted a Twitter photo to prove it. 

Jessica Alba joined Lautenberg to support his Safe Chemicals Act of 2011, the newest version of his many attempts to reform the Toxic Substances Control Act (TSCA).  Alba said that she was supporting TSCA reform because she is pregnant and is concerned about products intended to be used by young children that may contain chemicals not adequately tested.  She also is a spokesperson for the NGO coalition, Safer Chemicals, Healthy Families.

Unfortunately, it's unlikely that Alba's support will change the reality of the current stalemate in Congress.  While in Lautenberg's Senate the Democrats still hold a tiny majority, the House is now under the control of the Republican party, who show no inclination to take any regulatory overhaul other than cutting programs and budgets for agencies such as EPA that are charged with "protecting human health and the environment."  This despite industry assertions that they believe TSCA is in need of reform, aka, modernization.  Needless to say the NGOs believe TSCA reform is needed an have already deemed Lautenberg's newest iteration of the bill to have given in to industry concerns (too much in their opinion).

So it seems all parties say they want TSCA reform, but then don't seem inclined to actually act upon it.

According to Lautenberg:

“Under current policy, EPA can only call for safety testing after evidence surfaces demonstrating a chemical is dangerous. As a result, EPA has been able to require testing for just 200 of the more than 80,000 chemicals currently registered in the United States, and has been able to ban only five dangerous substances.”

European and Australian Chemical Agencies Agree to Cooperate on Chemical Safety

The European Chemicals Agency (ECHA) and the Australian Government's National Industrial Chemicals Notification and Assessment Scheme (NICNAS), have signed a memorandum of understanding (MOU) to "enhance co-operation" in an effort to "improve chemical safety."  The MOU will allow the two agencies to share expertise on technical matters on, among other things, "the hazards and emerging risks of chemical substances, risk management tools, scientific collaboration and information exchange."

This isn't the first cooperative arrangement for ECHA.   They signed a "statement of intent" with the USEPA last December in which the two agencies agreed to "share data, cooperate with each other on chemical reviews, and even exchange staff."

According to ECHA:

One of the anticipated areas of collaboration will be exchange of information. For example, the Memorandum of Understanding will promote the exchange of non-confidential information on hazards, uses and identity of chemical substances between ECHA and NICNAS. The agencies will also be sharing information on ways to more efficiently address chemicals of concern.

The full MOU can be downloaded as a PDF file here.

NGOs to Deliver Petition to White House Today to Call for Leadership on Chemicals

A coalition of NGOs and advocates for health and environmental safety are delivering a petition today to the White House calling for President Obama to implement last years findings by the President’s Cancer Panel.  Safer Chemicals, Healthy Families is a coalition of more than 100 organizations and "represents more than 11 million individuals and includes parents, health professionals, advocates for people with learning and developmental disabilities, reproductive health advocates, environmentalists and businesses from across the nation."  The petition has been signed by more than 70,000 people according to the group, and calls for strengthening of both the "failed" 1976 Toxic Substances Control Act (TSCA) and the "ineffective" 1938 Food, Drug, and Cosmetics Act (FDCA).  According to the petition:

Every minute, at least one American will die from cancer. What is particularly frightening about this statistic is that, contrary to general assumption, many of these cancers could have been prevented.

The petition urges "the President to 'most strongly use the power of your office' to eliminate human exposure to cancer-causing chemicals."  It goes on to say:

By setting the course for a national cancer prevention strategy that includes eliminating the use of cancer-causing chemicals, the President can reverse decades of failed policies that have allowed those chemicals to contaminate our lives and endanger our health.

The petition can be viewed on the Safer Chemicals, Healthy Families web site.

EPA Launches Online ECHO Database to Help Public Find Clean Drinking Water

The USEPA has launched a new searchable online database to help the public determine if their community meets federal clean drinking water standards.  The database, called ECHO, was developed by EPA along with state governments and "allows users to find inspection, violation, enforcement action, informal enforcement action, and penalty information about facilities for the past three years."

ECHO focuses on facility compliance and EPA/state enforcement of environmental regulations. Though the data included within ECHO have been in the public domain through Freedom of Information Act requests and mainframe computer subscription, the information was not available in a searchable Web format. ECHO makes it much easier for the public to obtain these data records on the Internet. 

Facilities regulated under the following environmental statutes are included in the ECHO database:

• Clean Air Act (CAA) Stationary Source Program, 
• Clean Water Act (CWA) National Pollutant Elimination Discharge System (NPDES), 
• Resource Conservation and Recovery Act (RCRA), and 
• Safe Drinking Water Act (SDWA).

The interface integrates the data from a variety of EPA databases.  ECHO includes "a snapshot of a facility’s environmental record, showing dates and types of violations, as well as the state or federal government’s response."  

Access to the ECHO database and more information can be found here.

More information about the data that are included can be found here.

ECHA Says Vast Majority of Intermediate Registrations Under REACH Do NOT Meet Requirements

In a rather stunning announcement, the European Chemicals Agency (ECHA) has issued a news release saying that the vast majority - 86% of the over 400 registration dossiers for intermediates screened - "seem not to contain sufficient information to demonstrate that these conditions are fulfilled."  Intermediates are substances that are manufactured for use in manufacturing other substances (and meet the definitions stipulated by REACH Article 3(15)), and that are manufactured and/or used under "strictly controlled conditions."  As intermediates they benefit significantly from reduced data requirements for registration.

ECHA is encouraging registrants of intermediates "to proactively reassess and, where necessary, update their registration dossiers."  If ECHA concludes that the dossier provided based on the intermediate requirements is insufficient, they may require "that a standard dossier be prepared instead."  Standard dossier data requirements will depend on the tonnage band of the production, but generally will include significantly more data - and more expensive data - then the intermediates dossier.

In order to demonstrate that a substance’s use fulfils the criteria of an isolated intermediate, a registrant should provide information on the identity of the transformation products resulting from the use of the substance and/or information on the manufacturing processes related to the registered substances. The registration dossier for an intermediate shall also include sufficiently detailed information on the risk management measures describing how strictly controlled conditions are ensured, including a description of the technical means used to rigorously contain the substance. This will enable ECHA to verify the intermediate status. 

ECHA says that it has "already communicated with registrants of a number of intermediate dossiers on missing or doubtful information, by inviting them to update the dossiers."  But they also are encouraging other registrants to reassess their dossiers and document that they are taking steps to provide any needed updates so that "that documentation can then be shown to inspectors on demand."

The ECHA announcement can be read here.

House Chairman Upton May Use Debt Ceiling Debate to Defund EPA's Climate Change Activity

The online newspaper Politico is reporting that Republican Fred Upton, chairman of the House Energy and Commerce Committee, is considering the possibility of using the debt-ceiling debate "as a vehicle for provisions that would limit federal climate change rules.

"  Upton’s bill to void "EPA’s power to regulate greenhouse-gas emissions" passed in April in the House, but failed when Senator James Inhofe tried to get it passed in the Senate.

EPA's attempts to deal with climate change through regulation of greenhouse gases has been thwarted by Congress, which insists that it, i.e., Congress, has the responsibility to set policy with respect to global warming.  It, i.e., Congress, has steadfastly refused to do just that, with the Republican party leading the fight against cap-and-trade legislation that they once touted as being a "market based solution."  As presidential aspirant and current Minnesota Governor Tim Pawlenty noted, all of the Republican candidates once felt that climate change was an important national and international problem, and that cap-and-trade was their preferred policy solution.  That was until the tea party gained a vocal platform.  Since then the Republican party has been doing flip-flops (or backflips) to change their tune purely for political expediency.


Just today in an Op-Ed in The Hill, former New Jersey Governor and EPA Administrator - and Republican - Christie Todd Whitman said that the Republican party would rue their complicity in climate change denial:

The debate over the future of the Environmental Protection Agency is one of those debates where an ideological agenda, disguised as budget cutting, will result in a short-term political statement at a long-term cost in dollars and health.

Whitman argued that Republican attacks on the EPA are "short-sighted":

Most importantly, Congress needs to consider the long-term cost of short-term decisions. Eliminating the EPA, or vastly curtailing its ability to regulate pollutants as science develops and identifies more threats to our health, may save a few dollars now, but the long-term cost to our society can be great. Using the scalpel rather than the hatchet is much more challenging, but it is the kind of thoughtful approach we need.

 Time will tell how much this short-sightedness for political expediency will adversely impact our children and grandchildren.

EPA Suspends the Submission Period for the Long-Awaited Inventory Update Rule (IUR)

Following many months of uncertainty, and with the deadline for industry submission approaching, the USEPA has issued a Federal Register Notice "amending the Toxic Substances Control Act (TSCA) Inventory Update Reporting (IUR) regulations by suspending the current June 1, 2011, through September 30, 2011, submission period for 2011 reports."  This action was necessitated because EPA till hasn't managed to finalize the IUR modifications rule that they have been working on since last year.

A revised submission period will be announced when the IUR modifications rule is finalized "in the next several weeks."  Once the rule is finalized EPA is promising that companies will have "sufficient time to comply with the updated IUR reporting requirements."  It represents a "one-time" suspension only, and the next scheduled reporting period is expected to be unchanged, i.e., June 1 to September 30, 2016.

According to EPA, "the suspension is warranted, EPA adds, "because it gives affected parties additional time to adjust their behavior in response to other portions of the proposed rule ... and because it averts potential confusion and duplication of effort, which could occur if other portions of the proposed rule, substantively affecting the submission requirements of the IUR, become effective in the midst of the IUR submission itself."

The Notice can be downloaded at: http://www.gpo.gov/fdsys/pkg/FR-2011-05-11/pdf/2011-11562.pdf

Environmental Groups Sue ECHA for Refusing to Release Names of Chemical Manufacturers

Two European environmental groups have sued the European Chemicals Agency (ECHA) for refusing to release the names of chemical manufacturers and importers of some of the most hazardous chemicals in the EU.  The lawsuit claims "several violations of European laws designed to promote transparency, democracy, and legitimacy in EU policy-making."  ChemSec, a Swedish-based NGO, was joined by environmental law organization ClientEarth in filing the suit.

The chemicals in question are the 356 chemicals on ChemSec's "SIN (Substitute it Now!) list."

The list comprises chemicals identified as Substances of Very High Concern under the EU chemicals regulation REACH. These are chemicals that can cause cancer, damage our reproductive system, or alter our DNA, as well as toxic substances that accumulate in nature with serious and long-term irreversible effects.

Last week I reported that ChemSec had added 22 chemicals to their SIN list based on their potential endocrine disruption effects.  Under the EU chemical control law, REACH, ECHA is required to give special attention to these "substances of very high concern." In their lawsuit, ChemSec and ClientEarth argue that:

ECHA has a track record of being slow to disclose information about chemicals; pressure from the chemicals industry has so far been successful in making delays characteristic of the Agency's approach, despite this policy's clear contravention of REACH and EU principles established for almost 20 years.

According to Vito Buonsante, toxics lawyer at ClientEarth: 

The public’s right to information on chemicals is a basic principle of the REACH Regulation. ECHA must not be allowed to withhold information on such a critical issue, especially as it relates to chemicals found in consumer products and present in the EU in large quantities. We have exhausted all avenues to make ECHA meet its transparency obligations and are now compelled to go to court.

More information on the lawsuit can be found on the ChemSec and ClientEarth web pages.

Senate Introduces Bill to Merge and/or Abolish EPA and Department of Energy

Republican Senator Richard Burr (North Carolina) introduced a bill last week that would "consolidate the Department of Energy and the Environmental Protection Agency into a single, new agency called the Department of Energy and Environment (DOEE)."  Senator Burr and fifteen other Republican co-sponsors argue that "the bill would provide cost savings by combining duplicative functions while improving the administration of energy and environmental policies by ensuring a coordinated approach."

Others suggest that this is merely an attempt to further gut the EPA.  Republicans in the House and Senate alike have been trying since gaining the majority in the House last fall to block any efforts of the EPA to engage in the regulation in which current laws mandate they engage.  Most notably has been the attempt to halt EPA efforts to regulate greenhouse gases under the Clean Air Act. 

One vocal critic of the bill is Joseph Romm, who writes the blog Climate Progress. Romm was "Acting Assistant Secretary of the U.S. Department of Energy, in charge of the Office of Energy Efficiency and Renewable Energy during 1997 and as Principal Deputy Assistant Secretary from August 1995 through June 1998, and Special Assistant for Policy and Planning from 1993 to July 1995."  So while Senator Burr suggests he seeks to reduce duplicative functions, Romm states:

So I can state with a great deal of confidence that DOE and EPA are utterly different agencies that have no meaningful duplicative functions.  [emphasis in original]

The list of the bill's co-sponsors is a tip-off to the real purpose of the bill.  All have been what Romm calls "global warming deniers" vying for the very conservative voting blocks in their home states.

The fate of the bill is uncertain.  Should the bill gain traction in the Senate, which is barely majority Democratic, it would likely be passed as is in the Republican-controlled House, thus leaving it up to President Obama to sign or veto.  Given the general trend toward fiscal austerity, it is highly likely that such a merger would result in severe underfunding, and ineffectiveness, for both agencies.  Which is apparently the goal given multiple past attempts to restrict each from taking any action on some of the most important long-term issues now facing the US and the world.  It's groundhog day all over again.

The Economist Demands Funding for Innovation to be Restored

The Economist, America's foremost "authoritative insight and opinion on international news, politics, business, finance, science and technology," is calling for the reinstatement of funding for the US Patent Office.  In an online editorial the magazine argues that Congress' rush to reduce funding stifles the very innovations that they profess the desire to encourage.

So how come Congress and the White House have decided not merely to underfund a crucial cog in American’s innovation machine but actually to take away revenue it earns?

According to The Economist, there are "more than 700,000" backlogged patent applications.  And "on average, hopeful inventors wait for two years until their applications are even considered. Ten months more may go by before they learn whether they have been successful. While they wait for a decision, the American economy is losing out."

They argue that it makes no sense to further slow the process. 

The backlog extends the uncertainty that the process causes to businesses, applicants and competitors alike, slowing investment and constraining the economy. 

But it doesn't stop there.  Congress has also been considering other patent reforms.  For example, one reform would "let the Patent Office determine its own fees and keep all the money that it collects."  This could help it reduce the backlog of applications.  And more importantly, both stimulate more inventors to innovate and speed up the process of getting those innovations to the people who can use them (perhaps to make even more innovations).

The article can be read in full in the online edition of The Economist.

Endosulfan to be Banned Under the Stockholm Convention

The widely used insecticide endosulfan is now on a path to be phased out and eventually banned under the Stockholm Convention, which is an international agreement designed to limit the use of chemicals that are considered persistent organic pollutants.  The decision was made in Geneva, Switzerland during meetings of the "Conference of the parties" held April 25-29, 2011. 

The Parties agreed to list endosulfan in Annex A to the Convention, with specific exemptions. When the amendment to the Annex A enters into force in one year, endosulfan will become the 22nd POP to be listed under the Convention. 

Annex A listing means that production, use, import, and export of the substance is banned.  This decision is a follow up to the recommendation by the POPs committee last fall.

The exemptions include a relatively long list of special cases requested by the two biggest users of endosulfan, i.e., India and China.  Endosulfan has been banned in about 80 countries because it is considered by many to be highly acutely toxic and an endocrine disrupter, as well as potentially very bioaccumulative.  The ban will take effect in 2012, with about 5 extra years available for the special case exemptions and to allow time to identify and develop safer alternatives.

More information is on the Stockholm Convention site.

NGO Adds 22 More "Endocrine Disrupter" Chemicals to its SIN List

An international chemical secretariat, Chemsec, has released an update to its "Substitute it Now!" list, aka, SIN List.  The first SIN list contained 356 chemicals that the NGO felt qualified as "substances of very high concern."  SIN 2.0 adds another 22 substances based solely on "their endocrine disrupting properties."  Chemsec argues that many of these are "commonly found in toys, food packaging, and cosmetics." According to their press release:

Endocrine disrupting chemicals (EDCs) can interfere with our hormone system and have been increasingly linked to a range of health problems including cancer, diabetes, behavioural and attention deficit disorders, as well as impaired fertility. We are all exposed to a range of EDCs via everyday consumer products as well as via food and water.

Chemsec believes that EDCs pose a significant threat to human health, and that while the EU has committed to addressing this threat, they have "so far not properly regulated their use.  Chemsec notes that hundreds of chemicals are considered of high concern, the EU has so far only designated 46 "substances of very high concern" under the REACH chemical control law, and of those, not a single one was listed specifically for their endocrine disrupting properties.


More information on the 22 new chemicals added to SIN 2.0 can be found on Chemsec's web site.

The list of 22 can be viewed here as a PDF file.

Chemsec's full SIN List database can be searched here.

ECHA Explains How Companies Can Apply for Chemical Substance Authorization Under REACH

The European Chemicals Agency (ECHA) held a seminar on April 12, 2011 to guide companies in how to apply for REACH authorization of chemicals placed on Annex XIV.  Now they have made the seminar presentations available online for all to download.  The seminar "was primarily targeted to potential applicants for an authorisation, and in particular for the first substances included in the Authorisation List, as well as the substances in ECHA's second recommendation for the inclusion of substances in the Authorisation List."

According to ECHA, about 40 people participated in the seminar.

The seminar agenda can be viewed here.  Topics included the content requirements for the Authorization application, the tools and guidance available from ECHA, and then an open discussion period where ECHA representatives and presenters answered questions.

The seminar presentations can be downloaded here.