Lisa Jackson Resigns as EPA Administrator

As comes as no surprise to anyone, EPA Administrator Lisa Jackson has announced that she will resign her post. While not giving an exact date, it is widely expected to be shortly after President Obama is sworn in for his second term and as late as his State of the Union address. Jackson did not indicate any particular position she had lined up but likely there are several options both in Washington DC and in her home state of New Jersey.

A successor has not yet been named, though current deputy administrator Robert Perciasepe will serve as acting administrator until a new administrator is nominated by the President and confirmed by the Senate. Perciasepe has been with the EPA off-and-on for about 20 years in various capacities. After leaving EPA in 2003 to serve as COO for the National Audubon Society, he returned at the request of Obama and Jackson in 2009.

Jackson's announcement is the most recent in the fire-sale of Cabinet-level resignations that often follows the reelection of a President. Other Cabinet officials who have announced they are leaving, or have at least unofficially signaled they would soon leave, include Secretary of State Hillary Clinton, Treasury Secretary Geithner, and others. Senator John Kerry has already been nominated by President Obama to be head of the State Department. Kerry has indicated, as has Obama, that climate change will be a relevant issue to be pursued in Obama's second term. This may impact the choice of a replacement for Jackson. While attempts to pass climate change legislation early in Obama's first term, including a bill co-authored by Kerry, as well as regulatory action by EPA, were met by Republican obstruction, look for the new EPA Administrator to have significant influence on this topic.

EPA and NSF Offer Grants for Green Chemistry, Life Cycle Research

The USEPA and the National Science Foundation (NSF) announced on December 20, 2012 that they would offer grants for up to ten different research projects - totaling $32 million. The grants will be divided between two areas of research.

For Networks for Characterizing Chemical Life Cycle research, interested parties can get more information here.

For Networks for Sustainable Molecular Design and Syntheses, interested parties can get more information here.

Requests for applications for the grants are due by March 18, 2013.

ECHA Lists 54 Substances of Very High Concern

The European Chemicals Agency (ECHA) plans to add another set of substances of very high concern (SVHC) to the candidate list under the REACH Regulation. The 54 new substances brings the total on the candidate list to 138. Most of the substances listed are CMRs, i.e., carcinogenic, mutagenic or reproductive toxicants, or PBTs, i.e., persistent, bioaccumulative and toxic. Three of the new substances are listed because they exhibit "equivalent concern," a more nebulous characteristic that covers any toxicity or other concern that does not fit neatly into one of the other categories, e.g., endocrine disruption, or in this case, strong respiratory sensitizers.

All of the substances on the candidate list are evaluated for inclusion on the Annex XIV Authorization list.

The full list of candidate list substances can be found in the table here.

ECHA Cancels REACH Registrations Because Companies Misrepresented Themselves

The European Chemicals Agency (ECHA) in Helsinki, Finland has revoked "a number of" REACH registrations because the registrants misrepresented their size. Size is important because the registration fee is dependent on the size of the entity submitting the registration. Small and Medium Sized Enterprises (SMEs) are allowed a significant discount to avoid disproportionate costs of registration compared to market value. According to ECHA, this "ensures equal and fair treatment of registrants." Companies declare their size when registering the fee is assigned automatically when the registrant makes their electronic dossier submission. Once submitted registration dossiers pass a completeness check, which includes payment of the fee, the registrant is given a registration. This generally occurs within three weeks of submission.

In their more comprehensive review since the November 2010 submission deadline, ECHA has determined that some companies inappropriately claimed they were SMEs when they did not, in fact, qualify for that designation or the reduced fee. Those companies that cannot document their SME status or pay the full size entity fee are considered to have failed the completeness check. In those cases ECHA has chosen to revoke the registration, which means the companies can no longer legally manufacture or import the chemical substance in question.

More details on the revocation can be found on the ECHA website.

Book Review – Am I Making Myself Clear? A Scientist’s Guide to Talking to the Public by Cornelia Dean

A much needed book for scientific and non-scientific communities alike. Written by science writer (and former New York Times editor) Cornelia Dean, the book makes the case that scientists need to make “their work more accessible to the media, and thus to the public.” This doesn’t come naturally to most scientists, and so the book gives some practical tips on how scientists can accomplish this goal.

Dean starts with “an invitation to researchers” to put aside their natural reticence and distrust of the media and help themselves and journalists get the key messages of their science across to the public. Because there are plenty of people out there who don’t hesitate to misinform the public about the science in order to protect their own interests (e.g., the climate change debate). In ensuing chapters she provides some insights into how scientists can better “know your audience,” help educate and work with journalists, and how to get the message across on radio and TV, online, and in the courtroom. She also offers tips on writing books, writing Op-Eds and letters to news outlets, and writing about science and technology in other venues.

Two of the most valuable chapters actually have to do with how journalists cover science issues. In “Covering Science,” Dean notes some of the differences in style and communication between journalism and scientific writing. These differences set up an inherent conflict. Scientific researchers view journalists as being superficial, insufficiently concerned with accuracy, focused on controversy, and even “ignorant.” In turn, journalists view researchers as boring, “caveating things to death,” prone to incomprehensible jargon, and incapable of drawing a definitive conclusion. In “The Problem of Objectivity,” Dean discusses the limitations of journalistic “balance” in which one opposing voice is given equal weight to the thousands of proponent voices because both sides are represented. This journalistic trait is exploited by, for example, climate change deniers, who know that TV interviews with one scientist and one naysayer (even if he is a non-scientist) looks to the public like “two sides” of a debate, even when the science is overwhelmingly in favor of one view. Given that it is often difficult for a journalist to know the state-of-the-art of the science, this opens the door for imbalance in an effort to provide balance.

Perhaps the most valuable chapter to scientists is “The Scientist as Source.” Here Dean provides some practical hints as to how scientists can best interact with journalists. Again she encourages scientists to put aside their hesitations to speak to the press and to embrace the opportunity to get out a message that accurately reflects both the research itself and the ramifications of that research to the public.

“Am I Making Myself Clear?” is quite readable, as one might expect from a science journalist. I recommend reading this book along with Chris Mooney and Sheril Kirshenbaum’s Unscientific America and Randy Olson’s Don’t Be Such a Scientist. All three books are useful to the scientist to help him or her relate better to the public, and to the public at large to better understand how science works.

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.

Andrew A. Rosenberg to Lead New Center for Science and Democracy

The Union of Concerned Scientists (UCS) has announced that  Andrew Rosenberg is joining the Union of Concerned Scientists (UCS) to serve as director of its new Center for Science and Democracy.  Rosenberg previously "served as the Northeast regional administrator of the National Oceanic and Atmospheric Administration’s National Marine Fisheries Service," and later as NMFS's deputy director. He is also the convening lead author of the oceans chapter of the U.S. Climate Impacts Advisory Panel. Most recently he was at Conservation International, where he was the senior vice-president for Science and Knowledge.

 The goal of the new Center for Science and Democracy is to restore" the essential role of science, evidence-based knowledge, and constructive debate in the U.S. policymaking process, using three core strategies:"

• Restoring public confidence in, and support for, the use of independent science in public policy making;
• Helping decision makers, citizens and journalists distinguish evidence-based information from propaganda;
• Working with scientists to help them become more effective communicators and policy contributors.

More information on the new Center for Science and Democracy can be found here.

Information on the other activities of the Union of Concerned Scientists can be found here.

Senate Passes Safe Chemicals Act out of Committee

The Senate committee charged with reforming the 1976 Toxic Substances Control Act (TSCA) has voted to send the bill proposed by Senator Frank Lautenberg to the full Senate for open debate and a possible vote. As expected after Tuesday's contentious hearing, the committee vote split along party lines with the ten Democrats voting for it and the eight Republicans voting against it.

Republicans argued that the vote on the bill introduced one and a half years ago was premature, and that there had not been time for the "bipartisan" discussions to reach fruition. Democrats countered that the bill had been substantially revised many times following dozens of hearings, stakeholder meetings, and private consultations with the Republican members. Senators Boxer and Lautenberg felt that it was important to get everyone's views out in the open so that their constituents could make judgments on whether to support the bill.

Indeed, the committee issued a 174-page Amendment that documents all of the changes to the original bill (S.847). They also issued a short summary highlighting the key changes.

Many of the changes incorporate the concerns of industry and the Republican minority. For example, the original bill introduced in 2005 would have required all chemical manufacturers to undertake a REACH-style data development in which all chemicals would need a substantial amount of health and safety data to be submitted prior to manufacture or in order to keep existing chemicals on the market. To incorporate industry concerns, the version passed by the committee yesterday "better focuses resources on priority chemicals" while continuing to require EPA to do most of the work of determining if a chemical is not safe. Existing chemicals would be evaluated in batches and screened through a prioritization process, then undergo safety determinations in order of priority.

The changes also require new information and testing "only when necessary." Data could be provided through means other than new testing when appropriate and defensible, for example, using QSARs, read-across, and non-animal studies.

Confidential business information (CBI) provisions have also been revamped to address industry concerns, and the new bill "better balances protection" of CBI versus the public's right to know about the chemicals to which they may be exposed.

As noted yesterday, it is highly unlikely that the Safe Chemicals Act will ever be passed by the Senate during this session of Congress, and even if it did come to a vote would likely never meet the 60-vote supermajority needed to even get to the actual up or down vote on the bill itself. And even if it somehow got that far, the House is highly unlikely to consider any bill at all. Facing this uphill battle the sponsors of the bill (Lautenberg and 21-cosponsors, all Democrats) felt it necessary to move the bill forward to all open expression of the conflicting views.

Information on the bill can be reviewed on the Thomas Library of Congress site.

Senate Moves TSCA Bill to Vote After Contentious Hearing

[Update: The Safe Chemicals Act has been approved by vote of the Committee on July 25, 2012] As noted yesterday, the Senate held a hearing on "EPA's authorities to control toxic chemicals." The hearing built on many previous hearings to gather information relevant to the reform of the TSCA chemical control law.  The hearing began fairly benignly but ended rather contentiously, with Senators Barbara Boxer (D-CA) and Frank Lautenberg (D-NJ) preparing for a markup of the Safe Chemicals Act bill today, July 25, 2012.

The hearing ostensibly was in response to an investigative series published recently by the Chicago Tribune. The Tribune series argued that "two powerful chemical industries - Big tobacco and chemical manufacturers - waged deceptive campaigns that led to the proliferation" of flame retardant chemicals such as the PBDEs. Witnesses during the hearing included Dr. Heather Stapleton, an expert on flame retardant chemicals at Duke University, and Marshall Moore, Director of Technology, Advocacy and Marketing at Chemtura, a manufacturer of PBDEs and one of the companies specifically identified by the Chicago Tribune.

In their opening statements the Senators offered reiterations of their usual positions. Democrats focused on the toxicity, persistence and bioaccumulation of PBDEs in particular and chemicals in general. Republicans, in particular Senators James Inhofe (R-OK) and David Vitter (R-LA), expressed their disappointment that the Democratic majority of the committee was planning to bring Lautenberg's Safe Chemical Act bill to markup. Republicans felt that this meant the end of the "bipartisan" discussions in which Democratic and Republican members of the committee and their staffs had engaged for the year and a half since the introduction of Lautenberg's bill.

Democrats countered that the "bipartisan" discussions were going nowhere and it was time to get Republican views out in the open with a markup and committee vote on the bill. Lautenberg reminded his colleagues that he first introduced a version of the Safe Chemicals Act in 2005 and that over the last seven years there had been dozens of hearings, meetings, and consultations with Republicans on the best way to reform TSCA. All stakeholders have agreed publicly many times that TSCA is in dire need of reform, a position EPA acting Assistant Administrator Jim Jones reiterated in his testimony. Indeed, Lautenberg's Safe Chemicals Act bill has clearly migrated from a more NGO-approved (all data for all chemicals) approach in the original to a more Industry-friendly (prioritization) approach in the current version. The markup is an attempt by Democrats to put the Republican position on record given that passage of a TSCA reform bill is highly unlikely in this Congress, and perhaps impossible in the next Congress depending on the results of this fall's election.

Democrats were clearly frustrated with the Republicans during the hearing. This became especially evident during the second panel in which Senator Boxer repeatedly made it clear which witnesses were called by the majority party (Democrats) and which were called by the minority party (Republicans). Boxer also repeatedly praised the courage of mother and former Maine House leader Hannah Pingree, who had said during questioning that "the chemical industry does not always tell us the truth." Boxer similarly praised the work of fireman Tony Stefani, who heads a Firefighters Cancer Prevention Foundation, which he started after he and his fellow firefighters were found to have higher incidences of the kind of cancers that he claims "are usually seen in workers in chemical manufacturing."

In contrast, Boxer several times addressed chemical manufacturing representative Marshall Moore in ways that can euphemistically described as "direct." She told Moore that "he needs to apologize" for "grossly distorting" a study on which he relied for demonstrating effectiveness and safety of flame retardant chemicals. Boxer also told Moore that "take a course in ethics" because the industry had set up a "phony fire safety group" (based on the charges in the Tribune series). Moore was remarkably calm and respectful given Boxer's direct accusations and insisted that his company and others had conducted and provided to EPA dozens of studies to aid the assessment.


The hearing demonstrated that TSCA reform, despite the repeated public assurances by all stakeholders that modernization was necessary and desirable, is likely not going to happen. As noted, while the Republicans expressed their disappointment that the bill will go to markup and probably to a committee vote, Democrats expressed their continued desire to work on a bipartisan bill, which they now believe can better be accomplished by an open debate on the Senate floor where each individual Senator would be able to put their views on record.

Of course, even in the unlikely event that a bill could be passed in the Senate (virtually all bills now must pass 60 votes for cloture before they can even make it to the floor for a vote), there is essentially no chance that the Republican-controlled House would even take up a companion bill.


More information and downloads of the testimony can be found on the committee hearing page.

TODAY - Senate Hearing on Exposures to Toxic Chemicals

There will be a Senate hearing today, Tuesday, July 24, 2012 to hear witnesses on the topic "Oversight on EPA Authorities to Control Exposures to Toxic Chemicals." The hearing is being held by the Full Senate Environment and Public Works Committee and its Subcommittee on Superfund, Toxics, and Environmental Health. The subcommittee is chaired by Senator Frank Lautenberg (D-NJ) who has been working for several years to modernize the Toxic Substances Control Act (TSCA) originally passed in 1976.

Lautenberg and other Democratic members of the committee are planning a markup and vote on his Safe Chemicals Act bill on Wednesday. Republican members immediately balked at the idea, noting that they were not given any warning of the vote. At the previous hearing by this subcommittee many months ago, Democrats had practically begged Republicans and industry to "give us a bill," i.e., rather than merely say the current bill was inadequate, actually propose a bill that Republicans and industry could live with given that all parties claim to want a workable modernization of TSCA. Republicans and industry declined to do so.

While the Safe Chemicals Act - TSCA reform - has been largely ignored during this election year, it has received renewed interest lately as the result of a Chicago Tribune investigative series that accused the chemical industry of misleading the public and regulators about both the effectiveness and safety of brominated flame retardants.

Today's hearing begins at 10:00 am ET in room 406 of the Dirksen Senate building. The hearing will be webcast. The full agenda and list of witnesses is below:

Opening Remarks

Panel 1

The Honorable Jim Jones Acting Assistant Administrator for the Office of Chemical Safety and Pollution Prevention U.S. Environmental Protection Agency

Panel 2

Hannah Pingree Mother, Former Speaker of the Maine House of Representatives

Dr. Heather M. Stapelton Assistant Professor of Environmental Chemistry, Environment Sciences & Policy, Nicholas School of the Environment Duke University

Marshall Moore Director, Technology, Advocacy and Marketing Great Lakes Solutions, A Chemtura Business

William K. Rawson Partner, Chair, Environment, Land & Resources Department Latham & Watkins LLP

Tony Stefani President, Founder San Francisco Firefighters Cancer Prevention Foundation

 

Poll Shows Most Americans Want to Update Chemical Control Law

A new poll conducted by Public Opinion Strategies, a leading Republican polling firm, shows that "voters are concerned about the effects of exposure to toxic chemicals in day to day life." The poll also shows that "most voters support 'stricter regulation of chemicals produced and used in everyday products.'"

POS conducted the national telephone survey of 800 registered voters on June 25-27, 2012. The overall margin of error is +3.46%. Interviews were distributed proportionally throughout the country. More information on the poll results and methods can be found here.

Poll results show that 77% of respondents support specific legislation to reform the Toxic Substances Control Act (TSCA), the law passed in 1976 for which all stakeholders (industry, NGOs, EPA, health and environmental advocates) agree needs to be modernized. Support for reform of the law was "wide-spread and broad-based," i.e., large majorities of all demographics surveyed agreed that the law was in need of updating.

POS concluded that "U.S. voters overwhelmingly support reform to regulations overseeing chemicals produced and used in everyday products, particularly when provided with specifics about what the reform might entail." Even when robust arguments on both sides of the issue were presented, "voters continue to side with supporters of reform."

TSCA reform has been the subject of many attempts by Senator Frank Lautenberg (D-NJ) and others to introduce legislation. Lautenberg's most recent effort, the Safe Chemicals Act, has languished in Committee without action. This might change this week, however, as Lautenberg says he expects to bring the bill to markup this week, which may lead to a Committee vote as early as Wednesday.

Meanwhile, the subcommittee and full committee of the Senate Environment and Public Works Committee has scheduled a hearing for Tuesday, July 24th to discuss Congressional oversight of EPA authorities related to TSCA. Of specific interest is a recent investigative series by the Chicago Tribune that suggested the brominated flame retardant industry had overstated benefits and understated risks of a class of flame retardants called PBDEs. This builds on a hearing held recently by Senator Dick Durbin (D-IL).

Senator Durbin Holds Hearing on Brominated Flame Retardants

Senator Dick Durbin (D-IL) held a hearing on Tuesday, July 17, 2012 regarding the question:

AreConsumers Adequately Protected from Flammability of Upholstered Furniture?  Hearing on the Effectiveness of FurnitureFlammability Standards and Flame Retardant Chemicals.

Durbin's concern stems from a recent Chicago Tribune investigative series that suggested the flame retardant industry had misled regulators on both the effectiveness and safety of a class of brominated flame retardants called PBDEs. The Senator is a strong supporter of overhauling the 26-year old TSCA law and is a co-sponsor of the Safe Chemicals Act introduced by Senator Frank Lautenberg (D-NJ).


Scheduled witnesses at the July 17th hearing were:

 

Panel I

·        The Honorable Inez Tenenbaum, Chairman, Consumer Product Safety Commission.

·        James J. Jones, Acting Assistant Administrator, Office of Chemical Safety and Pollution Prevention, Environmental Protection Agency.

Panel II

·        August (Gus) Schaefer, Sr., Vice President and Chief Safety Officer, Underwriters Laboratories, Inc.

·        Andy Counts, CEO, American Home Furnishings Alliance.

·        Peter Van Dorpe, Chief of the Training Division for Chicago Fire Department.

More information on the hearing can be found here.

New EU Biocide Regulation Enters Into Force

The new Biocidal Products Regulation (BPR) enters into force in the EU today, July 17, 2012. The BPR replaces the Biocidal Products Directive (BPD) that had been the law governing biocides. There will be a transition period for some biocidal products already in the review process, but the new BPR moves much of the responsibility for approving biocides to the European Chemicals Agency (ECHA).  ECHA is also responsible for REACH, the chemicals regulation.

As a regulation, the BPR goes into force in all of the EU immediately.  The previous Directive had to be implemented by individual member state action.

More information on the new Biocidal Products Regulation can be found on ECHA's web site.

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.

Lautenberg Leads Bipartisan Group of 26 Senators in Calling for Reform of Toxic Chemicals Law

Senator Frank Lautenberg (D-NJ) and 25 other Senators, including three Republicans, wrote a letter to EPA Administrator Lisa Jackson yesterday to "express our support for...actions to address a class of flame retardant chemicals called polybrominated diphenyl ethers (PBDEs)."  PBDEs are "found in a number of everyday consumer products" and were the subject of a recent Chicago Tribune investigative report that "revealed that flame retardant manufacturers may have misled the public for decades regarding both the risks and efficacy of these chemicals."

As part of its chemical action plan issued in December 2009, EPA proposed several actions under its existing TSCA authority to address the risks of PBDEs and collect additional data for assessment. Some of those actions are in progress while the implementation of others are uncertain given the continuing attempts to cut EPA budgets and limit its use of TSCA authority.  In the letter the Senators "commend the EPA for taking steps to address PBDEs," but acknowledge that Congress must take action to reform the current TSCA law.

Lautenberg introduced his latest version of the Safe Chemical Act this past year but has been unable to move it even to committee debate because no Republicans have offered any support for discussions to take place.  Lautenberg did get three Republican Senators - Olympia Snowe and Susan Collins from Maine and Lisa Murkowski from Alaska - to sign on to this current PBDE letter and has hopes that Republicans will concede to begin debate on TSCA reform.  However, Senator Snowe is retiring at the end of this term and given the unlikelihood of any significant action being undertaken prior to the November elections, it may be that Lautenberg is leaning more on wishful thinking than any actual belief that Republicans will agree to support TSCA reform.

More information can be found on Senator Lautenberg's web page.

The letter can be viewed or downloaded as a PDF here.

EPA Posts Endocrine Disruptor Screening Program Management Plan

According to the USEPA:

EPA has posted the Endocrine Disruptor Screening Program (EDSP) Comprehensive Management Plan on its website. The purpose of the EPA's EDSP is to protect people, wildlife and our environment from chemicals that may affect endocrine systems by screening pesticides, chemicals and environmental contaminants for their potential effects on estrogen, androgen and thyroid hormone systems.  EPA's EDSP Comprehensive Management Plan provides strategic guidance for agency personnel and outlines the critical activities that are planned for this program over the next five years. The plan is intended as an internal planning document, but is being made available to the public in order to be as transparent as possible.

For more information, the plan is available at http://www.epa.gov/endo

ECHA Adds Thirteen Substances to Candidate List

The European Chemicals Agency (ECHA) has added thirteen new substances of very high concern (SVHCs) to the REACH candidate list.  This list serves as a staging area for substances to be added to Annex XIV of REACH, which puts them on a track to be banned pending authorization for limited uses for limited time periods.

According to ECHA:

"Four have been identified as SVHCs under the precondition that they contain certain carcinogenic constituents above the concentration limit for classifying these substances as carcinogenic. Five of the new SVHCs have been included in the Candidate List following a scrutiny of the comments received during the public consultation and the unanimous agreement of the Member State Committee (MSC). The further eight substances, which did not receive comments challenging the identification as SVHCs during public consultation, were directly added to the Candidate List."

More information and the full candidate list of substances can be found on the ECHA site.

House Republicans Disagree with Endocrine Society on Need for EDSP

This week the Endocrine Society issued a series of recommendations "that will strengthen the ability of the current screening programs to identify EDCs." And now comes word that House Republicans are circulating language for the pending fiscal year budget that tries to limit the scope of EPA's endocrine-disruptor screening program (EDSP).

The Republican language is couched as an effort to "avoid unnecessary chemicals testing." It also tries to limit budgetary spending in an effort to restrict EPA's ability to formulate and implement policies on hydraulic fracturing, mountaintop mining, and other environmental issues that EPA is mandated to oversee. 

It's unclear on what basis the House Republicans believe that endocrine testing is "unnecessary" given that the lead scientific organization in that field is recommending greater attention to the issue. Endocrine testing was mandated by the 1996 Food Quality Protection Act, and EPA is a decade behind development of the testing regime required by that law passed unanimously by Congress.

More information on EPA's Endocrine Disruptor Screening Program can be found here.

REACH-IT update scheduled for 11 July 2012

The European Chemicals Agency (ECHA) has announced that it will upgrade REACH-IT, the user interface needed to submit chemical dossiers for the REACH registration program.  The upgrade will occur on July 11, 2012. To prepare for the changeover, REACH-IT will be inaccessible from Friday 6 July 2012 at 14.00 hrs (Eastern European Time) until 11 July 2012 at 9.00 hrs, in order for ECHA to install the new version of the software and to migrate the data from the present to the new version of REACH-IT.

In addition to REACH-IT, ECHA has also recently released an updated IUCLID, now version 5.4.  IUCLID 5.4 must be used for all dossiers submitted beginning July 11th.  And not to be left out, ECHA has also released a new version of Chesar, the exposure and risk assessment tool needed to complete the analysis of risk. Various plug-ins to the IUCLID software, e.g., Technical Completeness Check, Fee Calculation, Dissemination, and CSR, have also all been upgraded and will be available as the release of the new REACH-IT.

More information can be found on the ECHA site.

Endocrine Society issues Statement of Principles on endocrine-disrupting chemicals and public health protection

The Endocrine Society, whose mission is "to advance excellence in endocrinology and promote its essential and integrative role in scientific discovery, medical practice, and human health," has issued a "statement of principles" regarding endocrine-disrupting chemicals and public health protection.  They propose "a streamlined definition for endocrine-disrupting chemicals (EDCs)" and offer recommendations "that will strengthen the ability of the current screening programs to identify EDCs."

The position statement is published in the September 2012 issue of the Society's journal, Endocrinology, in a paper authored by R. Thomas Zoeller and seven others.

Recommendations in the statement include:

• Basic scientists actively engaged in the development of new knowledge in relevant disciplines
should be involved in evaluating the weight-of-evidence of EDC studies, as well as in the design and
interpretation of studies that inform the regulation of EDCs;

• State-of-the-art molecular and cellular techniques, and highly sensitive model systems, need to be
built into current testing, in consultation with the appropriate system experts;

• Testing needs to include models of developmental exposure during critical life periods when
organisms may be most vulnerable to even very low-dose exposures;

• The design and interpretation of tests must incorporate the biological principle that EDCs act
through multiple mechanisms in physiological systems; and

• Endocrine principles, such as those outlined in this document, should be incorporated into
programs by the U.S. Environmental Protection Agency (EPA) and other agencies charged with
evaluating chemicals for endocrine-disrupting potential.

The statement also provides a list of principles intended to enhance the ability of current screening
programs to identify EDCs. Principles in the statement include:

• Environmental chemicals that interfere with any aspect of hormone action should be presumed to
produce adverse effects;

• EDC exposures during development can have effects on hormone action that cannot be corrected,
leaving permanent adverse impacts on cognitive function and other health parameters;

• People are exposed to multiple EDCs at the same time, and these mixtures can have a greater effect
on the hormone system than any single EDC alone; and

• The weight-of-evidence guidance developed by the EPA must be strengthened by adhering to
principles of endocrinology outlined here, including low-dose effects and nonlinear or nonmonotonic
dose-response curves.

More information can be found in the journal article.

Chesar 2.0 released and strongly recommended by ECHA for REACH

Announced by the European Chemicals Agency (ECHA):

ECHA launches a new generation of its Chemical Safety Assessment and Reporting Tool to further harmonise and improve information on the safe use of chemicals.

Helsinki, 20 June 2012 – Version 2.0 of Chesar is now available and can be downloaded from the revised Chesar website. ECHA has invested in the redesign of the IT technology of Chesar in order to enhance its stability and make it a better platform for further developments as part of the long term strategy for Chesar. Other improvements include: a redesigned user interface, more transparency in determining the scope of the required exposure assessment, a simplified risk characterisation and an updated version of the Targeted Risk Assessment (TRA) developed by ECETOC. The possibilities to import and export complete chemical safety assessments (CSAs) or CSA building blocks have also been extended.

With Chesar industry organisations can make available generic exposure assessments for the conditions of use in their sector. Single registrants may then import and use this information as a starting point for their own substance specific assessment. Using Chesar will contribute to efficiency and harmonisation in carrying out CSAs. Thus, ECHA strongly recommends (potential) registrants to systematically use Chesar for making chemical safety reports and exposure scenarios.

Today's release of Chesar 2.0 includes the functionalities for carrying out CSAs based on a IUCLID 5.4 dataset and to generate chapters 9 and 10 of the chemical safety report (CSR), with one exception: exposure estimations for consumer uses is not yet included in the current release, but will be included in version 2.1.

The full press release and more information are available here.

ECHA Calls for Comment on 10 Chemicals to be Banned

ECHA, the European Chemicals Agency based in Helsinki, issued a request for comment yesterday on proposals to ban ten additional chemicals under the Authorization phase of REACH.  All of the chemicals have been on the "candidate list" of Substances of Very High Concern (SVHC).  Currently there are 84 substances on the candidate list, of which 14 have already been placed in Annex XIV for eventual removal from the marketplace.  The first sunset date is in early 2013, pending applications for authorization from manufacturers who want to keep the chemical on the market while they develop alternatives.

The ten chemicals out for public comment are:

• Pentazinc chromate octahydroxide 
• Arsenic acid
• Formaldehyde, oligometric reaction products with aniline (technical MDA)
• Potassium hyroxyoctaoxodizincated dichromate
• Strontium chromate
• 1,2-Dichloroethane (EDC)
• Dichromium tris(chromate)
• 2,2'-dichloro-4,4'-methylenedianiline (MOCA)
• N,N-Dimethylacetamide (DMAC)
• Bis(2-methoxyethyl) ether (Diglyme)

According to ECHA, interested parties may submit comments on the draft recommendation by September 19, 2012.


More information can be found on the ECHA site.

Australia IMAP Lists 3000 "Stage One" Chemicals for Assessment

The Australian chemicals agency, which goes by NICNAS, has announced that it will implement its new Inventory Multi-tiered Assessment and Prioritisation (IMAP) framework "in a staged manner." Beginning July 2012, "NICNAS will begin assessing around 3,000 existing chemicals," which are now designated “Stage One chemicals.”

The characteristics used to identify "stage one" chemicals are listed in the table on the NICNAS site and include a) chemicals for which NICNAS holds exposure data, b) chemicals identified as
a concern or for which action has been taken overseas, and c) chemicals detected in international studies analysing chemicals present in the blood in babies’ umbilical cords.

NICNAS has set up an online searchable database for anyone wishing to find out which chemicals are included in Stage One.

Factsheets on the program can be found here.

ECHA Drops Proposal to Restrict Four Phthalates

The European Chemicals Agency (ECHA) has dropped its plan to restrict the use of four phthalate chemicals. The proposal had been put forth last year on the chemicals commonly called DIBP, DBP, BBP, DEHP.  However, after review an expert committee determined that the proposed restrictions could not be justified, ECHA last week retracted the proposal.


Denmark had asserted in 2011 that the four phthalates could affect sexual development.  The expert committee disagreed - they noted that the "available data does not indicate that there is currently a risk from combined exposure to the four phthalates." The committee also concluded that regulatory actions already being put into place would result in significant reduction of exposures, thus making the proposed restrictions somewhat redundant, yet overly punitive.


The decision is the first time the expert committee has refuted a proposed restriction from ECHA.  


A summary of the Danish report can be read here.

The full proposal can be downloaded here.