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.

EOA Posts List of Safer Chemical Ingredients

From the USEPA:

"The U.S. Environmental Protection Agency today posted a List of Safer Chemical Ingredients that contains chemicals that meet stringent criteria applied by the Design for the Environment (DfE) Safer Product Labeling Program. This program recognizes products that are high-performance and cost-effective while using the safest chemical ingredients. At present, more than 2,800 common household and other products carry the DfE Safer Product Label. This list of safer chemical ingredients will help product manufacturers identify chemicals that the DfE program has evaluated and identified as safer alternatives.  This list only includes chemicals in products that were voluntarily submitted for evaluation through the DfE Safer Product Labeling Program. There may be other chemicals not included in this list that are also safer."

The safer ingredients list can be found here. 

Former EPA Administrator Russell Train Has Died

Former EPA Administrator Russell Train passed away at the age of 92 on September 17, 2012. Train was the second Administrator of the Agency, serving under President's Nixon and Ford from 1973 to 1977. Prior to EPA he had founded several wildlife organizations and served as the first vice-president of the World Wildlife Fund (WWF). He was later made Chair Emeritus of the the WWF, returning there after leaving the EPA.

A statement by Carter Roberts at WWF can be read here.

An EPA biographer of Russell Train can be read here.

An article about Train's passing is here.

More information on Russell Train's career here.

ECHA Strengthens Compliance Check Strategy

From the European Chemicals Agency (ECHA):

"To ensure increased compliance of REACH registration dossiers, ECHA carries out both full compliance checks of the dossiers and now more effectively also targets its evaluation to specific parts of them.

In a full compliance check, ECHA addresses the full dossier content in a single evaluation exercise, especially for randomly selected registration dossiers. This means that ECHA performs a systematic evaluation of all information requirements in the technical dossier (e.g. physico-chemical, environmental and human health endpoints), including the corresponding elements and conclusions provided in the chemical safety report (i.e. PBT/vPvB assessment, classification and labelling, exposure assessment and risk characterisation). Where a dossier is non-compliant with an information requirement, ECHA will request the information in a single decision. The decision is taken in cooperation with the Member States.

In a targeted compliance check, ECHA evaluates only a specific part of the registration dossier based on specified concerns. Selected (groups of) endpoints or criteria, called areas of concern, have been identified that are in particular relevant for the safe use of substances.  The ultimate goal is to focus on those endpoints that matter for human health and the environment. Emphasis will be given to Persistent, Bioaccumulative and Toxic (PBT);  Carcinogenic, Mutagenic or Toxic to reproduction (CMR); or sensitising (S) properties of a substance. IT-assisted targeting combined with expert judgement will help to achieve the necessary increased compliance of the registration dossiers. The chances of non-compliant dossiers being picked up for compliance check are now higher. Dossiers submitted individually outside an existing joint submission and dossiers with obviously incomplete essential elements will be automatically selected for compliance check."

The full press release can be read here.

Industry Groups Say Safe Chemical Act Does Not Include Republican Input

On Monday the Environmental Defense Fund issued a summary of the main provisions of the Safe Chemicals Act and how they "fulfill every detail" of the Industry "10 Principles" for TSCA reform as put forth by the American Chemistry Council. On Tuesday Industry addressed a letter to the Senate disagreeing with that contention, though not specifically rebutting it. The letter was signed by 69 chemical organizations representing "each step in the supply chain."

The basic premise of the letter is that Republican member input was not fully considered in the present Safe Chemicals Act passed out of the Environment and Public Works Committee late last month. The letter notes that "attempts have been made to characterize the current version of S. 847 as a compromise bill that could gain the support of Republicans and industry." The letter goes on to say that "this is not the case for the bill in its current form."

The industry letter confirms that industry "wholeheartedly support the continuation of a bipartisan process to discuss the right concepts needed in legislation to effectively reform the [EPA's] ability to regulate chemicals." Industry does not, however, believe that the current bill accomplishes this goal.

Now that the bill has been passed out of Committee it becomes eligible for a full debate of its merits on the Senate floor by all members of the Senate. Democrats in the Senate have indicated that they are more than willing to bring the bill up for debate, so it would seem that Industry and their Republican representatives in the Senate will have the opportunity to publicly present their views on what they agree with in the bill and what they do not agree with, along with solutions. Given that all stakeholders - Industry, NGOs, public health and environmental advocacy groups, parent groups, EPA and others - have agreed that TSCA needs to be reformed, it seems that the Safe Chemicals Act bill gives all parties the opportunity to move toward that goal.

The EDF comparison between the Safe Chemical Act and ACC "10 principles" can be viewed here.

The ACC "10 principles" document can be viewed here.

Further information on ACC's position on TSCA reform can be viewed on their web site.

New Safe Chemicals Act "fulfills every detail" of Industry's principles for moderning TSCA

Dr. Richard Denison, Senior Scientist at the Environmental Defense Fund (EDF), has "developed a detailed 8-page table that shows, side by side, the principles and the new version of the Safe Chemicals Act, with citations to each specific provision of the Act." The principles in question are the "10 Principles for Modernizing TSCA" issued by the American Chemistry Council (ACC), the major trade association for the chemical industry.

According to Dr. Denison, "the alignment is strong" between the "10 Principles" and the provisions in the Safe Chemicals Act proposed by Senator Frank Lautenberg and passed by vote out of committee for discussion and vote in the full Senate. The ACC statement issued following the committee vote indicated that "after a cursory review, we believe the bill is still fundamentally flawed in many critical areas." However, Dr. Denison notes that:

The changes made to the Safe Chemicals Act specifically reflected the input received from all stakeholders, including the converging views that have emerged from several industry-NGO dialogues held over the past 18 months.

He thus reaches the conclusion that "ACC’s complaints are more about politics than about substance."

Denison has provided a PDF link to his side-by-side table that details his comparison of the bill's provisions versus the ACC "10 Principles."


The full blog article by Dr. Denison can be read here.

EPA Announces Availability of Risk Assessment Plans for 2012 Work Plan Chemicals

This morning the EPA published Peer Review Plans for the risk assessments on the seven chemicals previously identified as 2012 work plan chemicals. According to EPA, "the plans, which form part of the Agency's Peer Review Agenda, describe the focus of the risk assessment being conducted on each chemical, indicate how peer reviewers will be selected and how the peer review will be conducted, and provide the time line for the reviews."

The External Review Drafts of the plans still need to be published in the Federal Register, and when that happens and the risk assessments become officially available there will be a 60-day public comment period. There will also be conference calls of the peer review panel in which the public can provide additional comments. 

EPA notes that the public can access and submit comments on the individual peer review plans for each chemical by using the following links:

• Antimony and Antimony Compounds
• HHCB (1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8,-hexamethylcyclopenta[g]-2-benzopyran)
• Long-Chain Chlorinated Paraffins
• Medium-Chain Chlorinated Paraffins
• Methylene Chloride
• N-Methylpyrrolidone
• Trichloroethylene

ECHA Publishes Practical Guide for Reporting Toxicity Data for REACH

ECHA has announced that it has made available a new "practical guide" to assist REACH registrants in "How to prepare toxicological summaries in IUCLID and how to derive DNELs." The guide "supports registrants in correctly summarising the toxicological information for substances in section 7 of IUCLID 5.4."

The most critical part of the guide explains how to undertake the take of "Derivation of No Effect Levels" (DNELs), which are used to compare toxicity to exposure in the assessment of risk. DNELs must be derived for all relevant toxicological endpoints (e.g., oral and dermal exposures) and represent the effects side of the equation for human health concerns. For environmental concerns there is a similar derivation of "Predicted No Effect Levels" (PNECs) for aquatic and terrestrial organisms. PNEC derivation is not discussed in the new practical guide.

More information on the Practical Guide can be found on the ECHA web site.

The Practical Guide in PDF format can be downloaded directly here.

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.

EU to Update Stockholm Convention POPs Chemical Plan

The European Commission (EC) has announced that it is reevaluating and updating the implementing plan for the Stockholm Convention on Persistent Organic Pollutants. The Stockholm Convention is a "global treaty to protect human health and the environment from chemicals that remain intact in the environment for long periods, become widely distributed geographically and accumulate in the fatty tissue of humans and wildlife." A plan was originally drawn up in 2007 and "a significant number of the actions identified in the 2007 Plan have now been finalized or are about to be finalised." Hence the need for an update.

A consultation has been opened on the European Commission web site and interested parties have between August 2 to October 25, 2012 to provide comment.

The full consultation document is available as a PDF download here.

ECHA to make more data on chemicals available

According to an ECHA news release:

"Beginning in November, ECHA will make more information from registration dossiers available on its website. This will implement a decision taken by ECHA in 2011 and is in line with Article 119(2)d of REACH. With these new elements, information made available will include the name of the registrant, the registration number of the substance as well as other items normally contained in a Safety Data Sheet (SDS). Companies wishing to request confidentiality on these items need to update their dossiers and justify their requests for confidential treatment."

 More information can be found on the ECHA web site.

Senator Lautenberg Calls for Senate Vote on Safe Chemicals Act

Senator Frank Lautenberg (D-NJ) is calling for a vote in the full Senate on his Safe Chemicals Act. Originally introduced April 14, 2011, the bill was passed out of the Environment and Public Works Committee last week. The bill is "designed to protect Americans from dangerous toxic chemicals that are found in everyday consumer products." Lautenberg now wants the bill to get a vote in the Senate.

A 174-page Amendment that documents all of the changes to the original bill (S.847) was released by the Committee. The committee also issued a short summary highlighting the key changes. These changes comprehensively alter the bill from its original "NGO-friendly" form to its now very "Industry-friendly" form. Still, Lautenberg has not been able to get any Republican to join the 25 Democratic co-sponsors of the bill. Lautenberg called on his fellow Senators to put the bill to a vote,  "either for or against." He noted that "families deserve to know" what Senators from both sides of the aisle "are thinking as we go through this process."





After languishing for nearly one and half years after its introduction, the bill took on new emphasis following an investigative reporting series by the Chicago Tribune. The Tribune reported that there had been collusion between the chemical industry and the tobacco industry to overstate the effectiveness of flame retardants and understate the health risks. A rather contentious hearing was held the day before the Committee vote, during which Senator Boxer went so far as to suggest one of the witnesses should "take a course in ethics."

It is clear that Lautenberg does not expect the bill to pass a full Senate vote since it would need to reach 60 votes to invoke cloture just to bring it to the floor for a real vote. With only 53 Democrats and Independents possibly voting for the bill and all 47 Republicans likely voting against it no matter what changes are made in debate, the bill is essentially dead on arrival. But he does feel that after 7 years of introducing bills and making substantive changes that make the bill more industry-friendly, the public should know what each Senator believes about protecting human health and the environment.

EPA Issues Analysis of Alternatives for Bisphenol A (BPA) Uses

The USEPA has issued a draft analysis of alternative chemicals that can be used instead of Bisphenol A (BPA) in thermal paper. According to EPA's Design for the Environmenet (DfE) program:

This draft report is an assessment of 19 chemical alternatives that may substitute for BPA, which is used as a developer in thermal paper. In addition, this report provides background information about how thermal paper is made, and considerations for choosing an alternative. A chemical's inclusion in the report does not constitute EPA endorsement. This draft report does not identify functional chemicals with low concern for all human health and environmental hazard endpoints; all of the alternatives are associated with some trade-offs.

The focus on thermal paper is because it "is widely used for cash register receipts, airline tickets, event and cinema tickets, and grocery store adhesive labels" and because this narrow focus was one area where alternatives exist. In addition, "workers in certain occupations, such as cashiers and restaurant servers who handle thermal paper often, may be at greater risk of exposure." Young children and teenagers entering the workforce may have especially high exposures. Concerns for BPA exposure include endocrine disruption and neurological changes.

The full 492-page PDF can be viewed or downloaded here.

The draft analysis can also be read online as smaller files here.

EPA Identifies Substitutes for Toxic Flame Retardant Chemical

The USEPA has released a draft report on alternatives to the "toxic flame retardant chemical known as decabromodiphenyl ether (decaBDE)." Acting Assistant Administrator Jim Jones had mentioned at a Senate hearing last week that the Agency was in the final steps of eliminating DecaBDE from products. This new action is part of EPA's Design for the Environment (DfE) program. The draft report being released "profiles the environmental and human health hazards on 30 alternatives to decaBDE, which will be phased out of production by December 2013."

EPA notes that "the alternatives to decaBDE characterized in the report are already on the market and will be used increasingly as decaBDE is phased out." EPA also notes that while overall the alternatives are considered good replacements for decaBDE, they have "differing hazard characteristics and are associated with trade-offs."

More information can be found in EPA's news release.

The full 812-page alternatives assessment for decaBDE can be viewed as a PDF here.

More information about the flame retardants alternatives project can be found here.

More information on EPA's DfE program can be found here.