GAO Tells Congressional Panel It Will Review Changes to IRIS Chemical Assessment Process

At a House Science Committee hearing this week, GAO environmental department director David Trimble testified that the GAO was currently undertaking a review of EPA's revised 2009 IRIS assessment process and how EPA was proceeding in implementing changes recommended by the National Academy of Sciences.  Trimble indicated that the 2009 revisions "appeared to represent significant improvement, but the viability of the IRIS program will depend on effective and sustained management and oversight."  The process revisions were initiated by EPA Administrator Lisa Jackson following extensive complaints about the quality of assessments performed during the Bush Administration.

IRIS refers to the Integrated Risk Information System, a human health assessment program that "evaluates quantitative and qualitative risk information on effects that may result from exposure to environmental contaminants...The information in IRIS is intended for those without extensive training in toxicology, but with some knowledge of health sciences."

In their continuing efforts to improve the oft-maligned program, EPA on July 12, 2011 announced plans "to further strengthen and streamline" IRIS and implement the April 2011 recommendations by the National Academy of Sciences.  According to EPA:

The most recent improvements include: reducing volume and redundancy of assessments; fuller discussion of methods and concise statements of criteria used in studies for hazard evaluation; clearer articulation of the rationale and criteria for screening studies; implementing uniform approaches for choosing studies and evaluating their findings; and describing the determinants of weight that were used in synthesizing the evidence. In addition, EPA is working to set up a dedicated advisory committee that will exclusively focus on the quality, transparency and scientific rigor of IRIS assessments. EPA will also create a peer consultation step early in the development of major IRIS assessments. Continually improving the IRIS program is an ongoing priority for the Agency, and these efforts work towards this goal.

The full testimony of David Trimble can be read here.

US Senators Propose Banning Chemicals of High Concern Due to Endocrine Disruption

Senators John Kerry and Jim Moran, both Democrats, have introduced legislation that would effectively ban certain uses of chemicals found to pose a high concern for endocrine disruption.  The bill, called the Endocrine-Disrupting Chemicals Exposure Elimination Act, would establish a research program to determine if candidate chemicals are endocrine disruptors, then ask an expert panel to rank them as either "high," "substantial," "minimal," or "no" concern.  The bill would require this panel to assess up to ten chemicals per year.  It would also require an exposure reduction strategy for those deemed to be of high concern.

The bill comes as Congress has seemingly reached a stalemate on how to proceed with reform of the 35-year old Toxic Substances Control Act (TSCA).  Senator Frank Lautenberg introduced the latest version of his Safe Chemicals Act earlier this year, and while at least one in a series of non-public stakeholder meetings have been held to fine-tune the bill, no obvious path forward on passage appears to be in the works.  Likewise, it is unclear what chances the Kerry/Moran bill will have in passage given the clear lack of any action being taken by the Republican-controlled House.


According to Kerry's press release:

Today, there are approximately 80,000 known chemicals in our environment that are potentially harmful, yet many of these chemicals are not tested to determine their effects on human health. This includes common products Americans use every day such as household cleaners, cosmetics or personal care products.  There is an increased rate of disorders affecting the human endocrine system, which children developing in the womb are particularly vulnerable to.

In introducing the bill, Senator Kerry noted that:

“We have a responsibility not just to inform Americans of the dangers, but to protect them from chemicals with the potential to cause serious illnesses from birth defects to cancer. It’s just common sense.”

EU Commission to Ban Biocide Uses for Eight Chemicals

Last week the European Commission issued a decision "concerning the non-inclusion of certain substances in Annex I, IA or IB to Directive 98/8/EC," i.e., to ban specific uses for eight biocidal chemicals.  The decision gives manufacturers and formulators until July 1, 2012 to phase out use of the substances for the biocidal product types indicated.  After that date they will be banned from being placed on the market.

The substances and product types for which they will be phased out are:

Formaldehyde: Human hygiene products, drinking water disinfectants, fibre/leather/rubber materials, vermin

2-Chloroacetamide: Veterinary hygiene products, in-can preservatives, metalworking fluids preservatives

Thiabendazole: Private and public health area disinfectants, metalworking fluids preservatives

2,2'-dithiobis[N-methylbenzamide]: metalworking fluids preservatives

Sulphur dioxide: Human hygiene products, private and public health area disinfectants, in-can preservatives, film preservatives, metalworking fluids preservatives

Reaction product of dimethyl adipate, dimethyl glutarate, dimethyl succinate with hydrogen peroxide/Perestane: Food and feed area disinfectants

Oligo(2-(2-ethoxy)ethoxyethylguanidinium chloride): Human hygiene products, drinking water disinfectants, in-can preservatives, metalworking fluids preservatives


Poly(hexamethylendiamine guanidinium chloride): Human hygiene products, drinking water disinfectants, in-can preservatives, metalworking fluids preservatives

Any other uses not listed are still authorized to continue beyond the phase out date.  In all cases, the uses above were not supported by the manufacturers.

EU Science Committees Call for Comments on How REACH Can Handle "Chemical Mixtures"

Three scientific committees of the European Commission have issued a "preliminary opinion" on how REACH and other chemical regulations can address the risks of chemical mixtures.  The three committees -  the Scientific Committee on Consumer Safety (SCCS), the Scientific Committee on Health and Environmental Risks (SCHER) and the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) - are now opening a public consultation and asking for feedback on the document, "Toxicity and Assessment of Chemical Mixtures."

REACH, the European chemical regulation, is a substance-based law, though some substances as defined can include mixtures of either discrete or variable composition chemicals.  Still, there is concern that mixtures of chemicals, sometimes called "chemical cocktails," could have greater toxicity than the sum of the toxicities for the individual chemicals.  This paper by the three committees attempts to address this concern, though no new amendments to the REACH law were proposed at this time. 


According to the press release, the main conclusions of this preliminary opinion are:

• Chemicals with common modes of action may act jointly to produce combined effects that are larger than the effects of each mixture component alone.
• For chemicals with different modes of action (i.e. acting independently), no robust evidence is available that exposure to a mixture of such substances is of health concern if each individual chemical is present at or below their no effect levels.
• For chemicals that interact, interactions (including antagonism, potentiation, synergies) usually occur at medium or high-dose levels (relative to the lowest effect levels). At low exposure levels they are either not occurring or toxicologically insignificant.

The deadline for comments is September 9, 2011.  Commenters are asked to use a special web site to assist the EU in compiling what they expect to be a significant number of comments.

OMB Review of Inventory Update Rule Complete - Expects to Publish Soon

After a long and anxious wait, the Office of Management and Budget (OMB) has finally completed its review of EPA's inventory update reporting rule (IUR) changes.  The delay in OMB review had caused EPA to suspend the reporting period, which was supposed to have run from June 1 to September 30, 2011.  The proposed rule revised the amounts and types of information that chemical manufacturers and others had to report to EPA under the IUR.  While OMB hasn't released its findings yet, it appears they will approve the rule but recommend some changes.

Basically the IUR is designed to provide EPA with key information on chemical production and processing in the United States.  The data companies are required to submit includes information that can help EPA - and the public - assess exposure to the chemicals that are on the reporting list.  These data, along with hazard data such as toxicity and environmental fate information, are used to identify potential risks to the public.

Since OMB does not expect to publish their findings for several days or even weeks, EPA must wait before they can set a new reporting deadline.  In the past EPA representatives have tried to ease industry anxiety by insisting there would be adequate lead time for companies to collect the information needed prior to a new reporting period.  Obviously, most of the data that need to be submitted are the same as has been done by industry for several previous IUR reporting periods, and with the EPA changes already identified in the proposed rule, industry should already be in a position to start collecting data.  Because of the OMB delay, EPA will likely be under pressure to set the new reporting period sooner rather than later to avoid disrupting the next cycle of IUR reporting, so it would behoove companies to start the process internally while waiting for publication.

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.