EPA Releases Draft Risk Assessments Under Existing Chemicals Work Plan

From the USEPA Press Release:


"EPA today released for public comment draft risk assessments, for particular uses, on five chemicals found in common household products. The draft risk assessments were developed as part of the agency’s Toxic Substances Control Act (TSCA) Work Plan, which identified common chemicals for review over the coming years to assess any impacts on people’s health and the environment. Following public comment, the agency will seek an independent, scientific peer review of the assessments before beginning to finalize them in the fall of 2013." 

The chemicals and specific use for which risk assessments were released are:

• methylene chloride or dichloromethane (DCM) and n-methylpyrrolidone (NMP) in paint stripper products; 
• trichloroethylene (TCE) as a degreaser and a spray-on protective coating; 
• antimony trioxide (ATO) as a synergist in halogenated flame retardants; and 
• 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8,-hexamethylcyclopenta-[γ]-2-benzopyran (HHCB) as a fragrance ingredient in commercial and consumer products.

A brief summary of the risk assessments can be downloaded in PDF format.

More information can be read on the EPA website.

FutureTox: Building the Road for 21st Century Toxicology and Risk Assessment Practices

FutureTox: Building the Road for 21st Century Toxicology and Risk Assessment Practices—October 18–19, 2012

In just a few weeks, scientists will gather to participate in the "FutureTox: Building the Road for 21st Century Toxicology and Risk Assessment Practices" meeting. FutureTox will address the challenges and opportunities associated with effective and efficient implementation of cutting-edge toxicity testing technologies and tools that will inform hazard prediction and risk assessment. This SOT Contemporary Concepts in Toxicology meeting will be held on October 18–19, 2012, in Arlington, Virginia. In addition to SOT, the Dow Chemical Company, US Food and Drug Administration (US FDA), ILSI Health and Environmental Sciences Institute Risk 21, Human Toxicology Project Consortium, and the National Institute of Environmental Health Sciences (NIEHS) are sponsors. FutureTox will provide information of great relevance to scientists in academia, government, and industry.

The Organizing Committee includes James S. Bus and Craig Rowlands, The Dow Chemical Company; Kim Boekelheide, Brown University; Russell S. Thomas, The Hamner Institutes for Health Sciences; Vicki L. Dellarco, US Environmental Protection Agency (US EPA); Marty Stephens, Human Toxicology Project Consortium; George P. Daston, Procter & Gamble; Suzanne Compton Fitzpatrick, US Food and Drug Administration; Raymond R. Tice, NIEHS; Robert J. Kavlock, US EPA; and Laurie C. Haws, ToxStrategies.

For general information, to review the program, and to register, visit the FutureTox website.

Japan Identifies 18 Chemicals for Closer Look after Priority Risk Assessments

After an extensive review of 86 chemicals, including detailed environmental and human health risk assessments, the Japanese government has identified 18 chemicals for closer review. The Tier I assessments resulted in five chemicals classified as substances that would be further monitored for production or import volume, mainly because they were considered likely to have fairly low levels. But 18 chemicals were deemed to be of significant enough potential risk to necessitate the Tier 2 assessments. Tier 2 assessments include requirements for manufacturers and importers to provide both health and safety hazard data and exposure information.

Eleven chemicals were identified based on their presumed risk to human health:

• hydrazine
• 1,3-butadiene
• dichloromethane
• 1,2-dichloropropane
• chloroethylene
• ethylene oxide
• 1,2-epoxypropane
• formaldehyde
• acrylonitrile
• toluidine

Seven chemicals were identified based on their presumed risk to the environment:

• 1,3-dichloropropene
• n-butyl acrylate
• isopropenylbenzene
• dichlorobenzene
• 2,6-di-tert-butyl-4-methylphenol
• [3-(2-ethylhexyloxy)propylamine]triphenylboron
• 4,4'-(propane-2,2-diyl)bis(phenol)

The Japanese government will perform the assessments in accordance with Japan's Chemical Substance Control regulation.

Toxicologists Recommend Changes to OECD Guidelines to Include Nanoparticles

Expert toxicologists from the OECD Working Party on Manufactured Nanomaterials (WPMN) have issued a report recommending that OECD guidelines be updated to better address the specific properties of manufactured nanomaterials.  The experts - about 50 scientists - met in October 2011 in the Netherlands specifically for "Inhalation Toxicity Testing for Nanomaterials" so their main focus was on inhalation toxicity.

The result was the report being issued now by OECD, which can be seen here.

The objective of the changes recommended to the inhalation toxicity guidelines was to better detect potential for harm from inhaled nanoparticles, specifically those engineered to be of nanoparticle size. Ideally the changes with assist researchers and regulators in understanding the unique properties created by the very small sizes of nanomaterials. These small sizes are especially important for inhalation exposures as they may allow materials to get further down into the lungs and possibly even cross the tissues into the bloodstream.

EPA Releases Chemical Work Plan - Names Chemicals for Risk Assessment

EPA has "developed a work plan that identifies existing chemicals for risk assessment over the next several years."  Today they "posted the methodology for developing this work plan, the work plan chemicals identified using the methodology, and seven chemicals for risk assessment development in 2012." EPA also posted an "existing chemicals program strategy," that "includes risk assessment and risk reduction, data collection and screening, and public access to chemical data and information."

We'll examine the strategy and work plans in more detail over the coming days, but here's a quick synopsis. Last September EPA announced that it would seek to identify existing chemicals for risk assessment under TSCA since the TSCA reform legislation was likely not to be seriously discussed in Congress for some time.  In a two-step process, EPA identified criteria for prioritizing chemicals based on their hazards, likelihood for exposure, and persistence/bioaccumulation. Scores for each segment are compiled from a variety of sources (to be discussed in future posts), categorized into high, moderate or low ranks, and given an overall score ranging from 1 (low) to 3 (high).  Chemicals receiving high scores in all or most of the segments get higher priority for assessment.

Since EPA resources are limited, and likely to get even more limited due to pending budget cuts, they have designated only seven chemicals for the 2012 work plan.  Another 76 chemicals have been designated for future year work plans.  

More details will come in future posts.  The seven chemicals listed for 2012 will be subject to EPA risk assessments.  They are:

• Antimony & Antimony Compounds
• 1,2,3,6,7,8-Hexahydro-3,6,6,7,8,8-hexamethylcyclopentag]-2-benzopyran (HHCB)
• Long-chain chlorinated paraffins (C18-20)
• Medium-chain chlorinated paraffins (C14-17)
• Methylene chloride
• N-Methylpyrrolidone
• Trichloroethylene (TCE) 

EPA Announces Plan of Action to Address Four IRIS Assessments

The USEPA  will be taking a closer look at "four draft Integrated Risk Information System (IRIS) assessments that were placed on hold in June 2010, pending a review of some of the underlying studies relied on in the assessments." The four assessments are methanol, methyl tertiary-butyl ether (MTBE), ethyl tertiary-butyl ether (ETBE), and acrylonitrile. 



These assessments have been on hold now for nearly a year because a National Toxicology Program (NTP) report questioned research completed by "the Ramazzini Institute, a lab in Italy that conducts animal testing to evaluate the potential cancer-causing effects of chemicals."   According to a previous press release:

NTP researchers reportedly raised questions about findings at the Ramazzini Institute, a controversial Italian animal testing lab that studies chemical carcinogenicity. The Institute has long been criticized by the chemical industry, particularly over its findings that aspartame sweetener can cause cancer.

EPA and the National Institute of Environmental Health Sciences (NIEHS) "decided to jointly sponsor an independent Pathology Working Group (PWG) review, in cooperation with the Ramazzini Institute, of selected studies, including the methanol cancer assessment study. The review has begun and will continue over the next several months. The results will be made public and the cancer assessment for methanol will remain on hold until its completion."
The USEPA announcement can be read here.

ECHA Says - Time to Start Preparing Chemical Authorization Applications Under REACH

I mentioned last week that the European Commission had formally published the first six chemical substances onto Annex XIV of REACH, the Registration Evaluation and Authorization (and Restriction) of CHemicals regulation in Europe.  Now ECHA, the European Chemicals Agency in Helsinki, Finland, is telling companies that manufacture those six chemicals that the time is now to start preparing their authorization applications if they want to save some uses of those chemicals for a period of time beyond the assigned "sunset" dates.  Authorization would only be for specific uses and for specific periods of time, though renewals are possible.

Applications can be pretty comprehensive.  They require a full Chemical Safety Report, which summarizes the health and safety hazard data, the exposure potential for all uses, and demonstrates how the risk will be controlled for specific uses.  In addition, companies have to provide a "alternatives analysis," i.e, an analysis of existing or potential chemicals of lower risk that can be substituted for the Annex XIV listed "substances of very high concern (SVHC)."  For chemicals in which no alternative appears to be available, the companies requesting authorization must describe a plan for how they (or someone else) might develop an alternative. Companies can also provide a socioeconomic assessment (SEA) in which they quantify the societal benefit of the chemical substance, or the loss of such benefit should it be removed from the market with no suitable alternative.

Since it is likely that a particular chemical substance would have more than one manufacturer, authorization applications may be made both by individual companies and by groups of companies.  An authorization fee would be charged to cover the costs of the ECHA review. 

To facilitate the preparation of the application ECHA has recently published two new guidance documents.  The first "explains how to prepare an application for authorisation, the analysis of alternatives and the substitution plan."  The second "shows how to prepare a socio-economic analysis if the risks of the continued use of the substance cannot be adequately controlled."  Both documents can be downloaded here.

EPA Holds Conference on the "Next Generation" of Chemical Risk Assessment

The U.S. Environmental Protection Agency (EPA) is holding "a two-day conference to discuss the Next Generation (NexGen) of Risk Assessment."  The conference starts today and runs through 1 pm ET tomorrow in Washington DC.  According to the EPA announcement:

"NexGen is a program that aims to create an inexpensive, faster system for chemical risk assessment by incorporating new knowledge about molecular biology. EPA scientists are using molecular biology, the study of how cells function, to help them interpret the risk to Americans’ health from exposure to chemicals in our air, water and soils. Through NexGen, EPA is collaborating with federal and state agencies to help people understand risks posed by chemicals in our environment so they can make more informed decisions about their health."

More information on the conference call be found here.

More information on NextGen can be found here. 



WHAT: Advancing the Next Generation of Risk Assessment: Public Dialogue Conference

WHEN: Tuesday, February 15, 8 a.m. - 5:30 p.m. and Wednesday, February 16, 9 a.m. - 1 p.m.

WHERE: Embassy Suites Convention Center; 900 10^th Street N.W., Washington, D.C