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.