India Meets Criteria to Join OECD "Mutual Acceptance of Data" Program

India has now met all of the requirements to be accepted into the OECD Mutual Acceptance of Data (MAD) program.  It did so by demonstrating that it could successfully conduct health and safety testing under Good Laboratory Practices (GLPs), which is the standard for such testing in all thirty-four of the OECD countries (which includes EU countries, the US and Canada, among others).  The achievement allows Indian chemical manufacturers to conduct and provide single tests in support of their products in all OECD countries.  This makes it easier and less costly to enter the marketplace.

The achievement is important because OECD consists of mostly economically developed countries, and India joins Brazil, Singapore and South Africa as the only developing countries to meet the tough OECD standards.  Being able to enjoy the benefits of the MAD program will greatly enhance marketability.  MAD is the system in which the results of a set of health and safety studies can be submitted in support of a product, and acceptance by a rapporteur member state is deemed acceptance by all member states.

ECHA Reports that REACH and CLP Chemical Regulations are "Working Well"

The European Chemicals Agency (ECHA) recently published two reports, both required by law, in which they conclude that despite many industry misgivings prior to enactment, the REACH and CLP regulations are "working well and that the various actors responsible for the work are responding as required." REACH is the chemical control law in Europe and the CLP is the Classification, Labeling and Packaging Regulation.  ECHA attributes the success largely to "the commitment and collaborative work between industry, stakeholders, the Member States, the European Comission and ECHA."

According to their press release, ECHA offers "three key lessons" from the experience:

•    The uncertainty over the number of registrations for the first deadline was a challenge to manage and more accurate estimates would be helpful in future.
•   Close working relationships with industry and stakeholders are vital to ensure success and the Agency can help by providing stable tools and guidance.
•    The interrelationship between the various elements of the two regulations is important and has become increasingly apparent.  For example, ambiguities in substance identification can lead to problems in forming Substance Information Exchange Fora (SIEF), evaluation and risk management activities. 

The report, which can be downloaded here as a PDF, offered recommendations for improving implementation of the laws in the future.

A second report on the implementation of efforts to reduce unnecessary animal testing can also be downloaded as a PDF here.

UPDATE - Only 3 of the 4 chemicals added to Rotterdam Convention PIC list

Last week I reported that the parties to the Rotterdam Convention were in discussion to add four chemical substances to the Prior Informed Consent (PIC) list.  The four substances were chrysotile asbestos, endosulfan, alachlor and aldicarb.  Well, now that the Fifth Conference of the Parties is over, they decided only to list three of the four.  Parties could not reach a consensus on the addition of chrysotile asbestos due to opposition from several countries, led by Canada and later joined by Kazakhstan, Kyrgyzstan, Peru and the Ukraine.

Agreement to list the herbicide alachlor and the insecticide aldicarb was reached quickly.  The addition of endosulfan was a bit more contentious because Cuba had argued that listing would cause significant implementation problems for developing countries.  After promises were made to provide technical and financial guidance the agreement to list endosulfan was reached.


These three chemicals will be added to Annex III to the Convention.  Further discussion on chrysotile asbestos will no doubt occur in future meetings of the parties. 

More information on Rotterdam and Prior Informed Consent can be found here.

European Commission Will Not Seek New Legislation for Nanomaterials

At a meeting of the European Commission this week commissioners confirmed that the EU plans to deal with  nanoscale materials primarily through its REACH chemical regulation rather than develop entirely new legislation specific to nanomaterials.  Commissioners noted that creating something new was simply not feasible at this time.

The Commission will, however, work with ECHA and other regulatory bodies to develop additional guidance documents to assist stakeholders in adequately characterizing and evaluating any specific risks posed by nanoscale materials.  While most nanomaterials are nano-sized versions of existing chemicals, the small size often results in differences in key physical-chemical, fate and transport, and potentially toxicity properties.  The goal is to find a balance between the need for additional information for the risk assessment and creating a massive new regulatory burden for companies, many of whom may be small or medium sized entities.

At this point there is quite a bit of uncertainty for industry, which must deal with a regulatory system that isn't yet predictable or consistent.  Even the definition of what the regulatory bodies believe constitutes a nanomaterial is not clear. Still, industry is generally in agreement that nanomaterials should be dealt with through REACH rather than have to deal with entirely new legislation.

EPA to Initiate Chemical Safety for Sustainability Plan

The USEPA is set to launch a Chemical Safety for Sustainability initiative.  The plan is to use innovative approaches to assess chemical hazard and exposure so this can be accurately communicated to the public.  According to their web site:

EPA scientists and their partners are embracing the principles of green chemistry to produce safer chemicals. They are also integrating a diversity of scientific disciplines to develop new prediction techniques, pioneering the use of innovative technologies for chemical toxicity testing, and designing tools to advance the management of chemical risks. Chemical safety for sustainability includes research in computational toxicology, nanotechnology, endocrine disrupting chemicals, human health, and pesticides.

As part of this ongoing process EPA recently made available two new chemical databases - ToxCastDB and ExpoCastDB.  These supplement the ToxCast robotic screening testing program started earlier by EPA.  The most recent announcement of the Chemical Safety for Sustainability initiative was made during the first meeting of the National Research Council's Committee on Science for EPA's Future, part of the National Academies of Sciences.


The three main areas of focus for the program are:

• Providing scientific knowledge, tools and models for integrated evaluation strategies
• Improving assessment and informing management for chemical safety
• Targeting high priority research needs for immediate and focused attention

GAO Calls for Improved National Priorities for Climate Change

The Government Accountability Office (GAO) has issued a report calling on the federal government to improve and clarify national priorities related to climate change.  Acknowledging that "climate change poses risks to many environmental and economic systems, including agriculture, infrastructure, and ecosystems," GAO noted that national priorities need to be set and "better align them with federal funding decisions."  While "funding for climate change activities reported by OMB increased from $4.6 billion in 2003 to $8.8 billion in 2010," GAO noted that it "is organized in a complex, crosscutting system."

Two key factors were identified that "complicate efforts to align funding with priorities."

First, notwithstanding existing coordinating mechanisms...federal officials do not have a shared understanding of strategic priorities. This is in part due to inconsistent messages articulated in strategic plans and other policy documents....Second, respondents indicated that since mechanisms for aligning funding with priorities are nonbinding, they are limited when in conflict with agencies' own priorities.

GAO came up with two recommendations:

1) To improve the coordination and effectiveness of federal climate change programs and activities, the appropriate entities within the Executive Office of the President, including the Council on Environmental Quality, Office of Energy and Climate Change Policy, Office and Management and Budget, and Office of Science and Technology Policy, in consultation with Congress, should work together with relevant federal agencies and interagency coordinating bodies to clearly establish federal strategic climate change priorities, including the roles and responsibilities of the key federal entities, taking into consideration the full range of activities within the federal climate change enterprise.

2) To improve the coordination and effectiveness of federal climate change programs and activities, we recommend that the appropriate entities within the Executive Office of the President, including the Council on Environmental Quality, Office of Energy and Climate Change Policy, Office and Management and Budget, and Office of Science and Technology Policy, in consultation with Congress, should work together with relevant federal agencies and interagency coordinating bodies to assess the effectiveness of current practices for defining and reporting federal climate change funding and aligning funding with priorities, and make improvements to such practices as needed for Congress and the public to fully understand how climate change funds are spent.

For more information and to download a highlights page and the full report, go to the GAO page here.

Four chemicals to be added to the Rotterdam Convention PIC list?

The fifth meeting of the Conference of the Parties (COP5) to the Rotterdam Convention starts today and will continue through Friday, June 24, 2011 in Geneva Switzerland.  On the agenda are decisions regarding the inclusion of four substances to the Prior Informed Consent (PIC) list. The four substances are chrysotile asbestos, endosulfan, alachlor and aldicarb.  If the decision is inclusion, the chemicals will be added to Annex III to the Convention.

The participants of COP5 also hope to adopt a strategic plan related to management of industrial chemicals worldwide, with emphasis on "synergies between the Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and Their Disposal, the Rotterdam Convention and the Stockholm Convention on Persistent Organic Pollutants." 

Alachlor and aldicarb are expected to be approved for PIC listing, while chrysotile asbestos and endosulfan may garner significant additional discussion as several participating countries have expressed their concerns based on economic reasons, i.e., that PIC listing is equivalent to blacklisting the chemicals from the market.

More information on the Rotterdam Convention and Prior Informed Consent can be found here and here.

ECHA Recommends 13 Chemicals for REACH Authorization (i.e., for the EU "to be banned" chemicals list)

The European Chemicals Agency (ECHA) has recommended thirteen additional chemicals for inclusion on its Annex XIV Authorization list.  These chemicals had been listed on ECHA's "candidate list" of Substances of Very High Concern" (SVHC).  Following consultation and comment, the 13 chemicals could be added to the list of chemicals that will be phased out from continued use, unless the manufacturer/importer applies for an "authorization" for an extended phase out period.  This is the third time ECHA has recommended a set of chemicals for inclusion on Annex XIV.


The following substances are on the third recommendation list:

1. Chromium trioxide;
2. Chromic acid, Oligomers of chromic acid and dichromic acid;
3. Sodium dichromate;
4. Potassium dichromate;
5. Ammonium dichromate;
6. Potassium chromate;
7. Sodium chromate;
8. Trichloroethylene;
9. Cobalt(II) sulphate;
10. Cobalt dichloride;
11. Cobalt(II) dinitrate;
12. Cobalt(II) carbonate;
13. Cobalt(II) diacetate.

According to ECHA's press release:

Using the web forms available on ECHA’s website, interested parties are invited to comment, in particular on the uses that should be exempted from the authorisation requirement.

More information about how to comment and the authorization process can be found here.

EPA Makes Available Two New Chemical Toxicity Databases

The USEPA has announced that it is making available two new databases to make it easier for people to find chemical data.  One database is the Toxicity Forecaster database (ToxCastDB) containing toxicity information.  The other is a database of chemical exposure studies (ExpoCastDB), which can be used to evaluate how much chemical to which people may be exposed.  Both are searchable.

The Toxicity Forecast database (ToxCastDB) can be used to download toxicity data from more than 500 rapid chemical tests that have been conducted on more than 300 environmental chemicals.  "ToxCast uses advanced scientific tools to predict the potential toxicity of chemicals and to provide a cost-effective approach to prioritizing which chemicals of the thousands in use require further testing."  Another 700 chemicals are currently being screened using ToxCast, with the data expected to be available by next year.

The ExpoCast database "consolidates human exposure data from studies that have collected chemical measurements from homes and child care centers."  According to EPA's press release, "data include the amounts of chemicals found in food, drinking water, air, dust, indoor surfaces and urine."  Additional external and internal chemical exposure data will be added as they become available. 

The new databases link together two important pieces of chemical research — exposure and toxicity data — both of which are required when considering potential risks posed by chemicals. The databases are connected through EPA’s Aggregated Computational Toxicology Resource (ACToR), an online data warehouse that collects data on over 500,000 chemicals from over 500 public sources.

Users can now access 30 years worth of animal chemical toxicity studies that were previously only found in paper documents, data from rapid chemical testing, and various chemical exposure measurements through one online resource. The ability to link and compare these different types of data better informs EPA’s decisions about chemical safety.
 

More information and links to the databases can be found on the EPA web site.

ECHA Forces Private Company to Close its REACH Chemicals Database

As part of its REACH chemical regulation program, the European Chemicals Agecny (ECHA) has created a database portal called REACH-IT by which companies are required to submit their REACH data dossiers and conduct other business with ECHA online.  ECHA has now forced one company, Eugachem, to stop selling information it had inappropriately obtained on pre-registered chemicals.

The first step of REACH was for companies to "pre-register" their existing chemicals, i.e., inform ECHA via the REACH-IT system that they intended to register existing chemicals in Europe.  This pre-registration gave companies the benefit of a grace period during which they could stay on the market while they developed their data dossiers.  Any chemicals not pre-registered would be considered "new" chemicals, and companies had to provide the data dossiers to ECHA prior to going on the market.

According to ECHA, they first became aware in June 2009 that the company Eugachem was selling information on pre-registrations; information that they had obtained from another company that had pre-registered the entire EINECS list (the former list of all existing chemicals in Europe). The company was essentially sued in the German courts and ECHA "considered Eugachem’s use of this information as a breach of ECHA’s copyrights in the REACH-IT database and the other company’s transfer of this information to Eugachem as a breach of ECHA’s terms and conditions of use of REACH-IT."

As a result of court action:

Eugachem has now agreed to discontinue the service and to destroy all data on pre-registered substances in its possession. The company that transferred the data to Eugachem has agreed to use the data that has been or will be taken from the REACH-IT database only within the scope of the “Terms and conditions of use and services of REACH-IT”. It further agreed to no longer transfer such data to third parties, and to identify those pre-registrations which it actually needs for fulfilling its obligations under REACH. Its other pre-registrations will be deleted.

More information and a reminder by ECHA of the terms and conditions of use of REACH-IT can be found on the ECHA web site.

NASA Launches Aquarius/SAC-D Satellite to Collect Global Warming/Salinity Data

In case you missed it, last Friday NASA, along with the Space Agency of Argentina, launched the international "Aquarius" satellite.  According to NASA, Aquarius "is a focused effort to measure Sea Surface Salinity and will provide the global view of salinity variability needed for climate studies." A Delta II rocket lifted off from Vandenberg Air Force base carrying the Aquarius/SAC-D spacecraft.  Within an hour it had "separated from the rocket's second stage and began communicating with ground controllers and unfurling its solar arrays."

The mission of Aquarius is to investigate the salinity of the oceans.  Within a few months, "Aquarius will collect as many sea surface salinity measurements as the entire 125-year historical record from ships and buoys."  These data will be invaluable in the investigation of the water cycle, ocean circulation, and climate change.

Regarding the climate aspects, the blog RealClimate, run by a group of world renowned climatologists, has a great summary of why the data Aquarius collects is so important.

You can follow the progress of Aquarius on the NASA web site here.

Nanotechnology News You Can Use

Nanotechnology is a hot topic these days, mainly because people are trying to figure out how, or even whether, to regulate them compared to the same chemical in non-nano form.  Nano, of course, refers to very small sized versions (usually < 100 nanometers) of chemicals that may already have widespread use (e.g., carbon, titanium dioxide, etc.).  The question comes down to whether the small size gives the substance different physical-chemical properties and/or makes it more likely to cause toxicity.

On June 9, 2011, the White House issued a memo instructing regulators in all federal agencies to use "flexible, adaptive, and evidence-based approaches that avoid, wherever possible, hindering innovation and trade while fulfilling the federal government's responsibility to protect public health and the environment."  The memo cautioned agencies to "avoid making scientifically unfounded generalizations that categorically judge all applications of nanotechnology as intrinsically benign or harmful,” and offered ten principles to address concerns.


Meanwhile, on the same day, the USEPA announced a proposed policy for obtaining information on what nanoscale materials are contained in pesticide products.  The proposal relies on a case-by-case approach to determine if a nanoscale ingredient should be considered "new active or inert ingredient" despite having a non-nano form already registered under FIFRA, the US pesticide law.

Finally, the FDA has gotten into the act by "taking the 'first step' toward greater regulatory certainty around nanotechnology." On the same day as the EPA and White House announcements, FDA released a "draft guidance to provide regulated industries with greater certainty about the use of nanotechnology, which generally involves materials made up of particles that are at least one billionth of a meter in size. The guidance outlines the agency’s view on whether regulated products contain nanomaterials or involve the application of nanotechnology."  The guidance names "certain characteristics – such as the size of nanomaterials used and the exhibited properties of those materials – that may be considered when attempting to identify applications of nanotechnology in regulated products."

All of these announcements reflect a worldwide effort to better characterize nano-scale materials and their safety to the public and environment.

 

EPA Goes Transparent Again - Removes Confidentiality Claims for 150+ Chemicals

In its continuing efforts to make chemical information more transparent, the USEPA has decided to make public "the identities of more than 150 chemicals contained in health and safety studies that had been claimed confidential by industry."  EPA is taking this, and other actions, to "provide the public with greater access to information on the chemicals that are manufatured and used in the United States."  According to Steve Owens, Assistant Administrator for EPA's Office of Chemical Safety and Pollution Prevention:

“A health and safety study with the chemical name kept secret is completely useless to the public.” 

As expected, the NGO advocacy community responded positively to the announcement, though they would prefer even more information to be released to the public.  The chemical industry, led by the American Chemistry Council, noted that it supported "EPA's mission to promote public understanding of the potential risks posed by chemicals in commerce," but also was concerned that "critical information needed by businesses to innovate and succeed in a competitive international marketplace” needed to be kept confidential."

 More information can be found at the EPA site here.

EPA Gets a "Scientific Integrity Officer"

The USEPA now has its first scientific integrity officer.  EPA named William Sanders, an EPA veteran who is currently the Director of the National Center for Environmental Research (NCER) at EPA to the position.  Sanders will be in charge of implementing EPA's new scientific integrity policy, which was initiated by executive order from President Obama and is due to be completed some time in the fall.

Sanders' appointment comes before an expected report from the Inspector General's office within EPA, which will include advice on what steps need to be taken to ensure the integrity of all scientific work done at EPA.  The IG recently faulted EPA for its lack of action identifying endocrine disruptor chemicals as required by two laws passed in 1996.  The upcoming IG report, expected this summer, reviewed EPA internal policies and processes and will provide advice on maintaining scientific credibility, identifying and dealing with scientific misconduct, and record keeping. 

Sanders has been at EPA for more than three decades in a variety of roles.  According to sources, the role as NCER chief has caused some to question his ability to take on the new appointment.  Apparently morale has been dropping since he started at NCER, with many employees choosing to leave.  Still, the scientific integrity officer role will allow Sanders to oversea the new integrity policy and incorporate the suggestions from IG and others.