Welcome to the new High Phthalates Panel newsletter. We hope these newsletters will keep you current with news about phthalates and demonstrate our dedication to the continued safe use of phthalates, which are essential to so many consumer and industrial products. Please share this information with your own contacts to help educate the entire value chain about the benefits of phthalates and about our advocacy activities.
If you have suggestions for additional content or stories, please contact
Eileen Conneely, (202) 249-6711.
Table of Contents
Consumer Product Safety Commission (CPSC) Chronic Hazard Advisory Panel (CHAP) on Phthalates Report Delayed
EPA Design for the Environment (DfE) Proceeds with Evaluation of Phthalates and Phthalate Alternatives
European Chemicals Agency Rejects Danish Proposal to Restrict Four Phthalates under REACH
EPA to Explore Use of Section 6 of TSCA
ECHA Draft Report on DINP and DIDP Toy Restrictions States that No Further Risk Reduction Methods are Necessary
Australian Government Department of Health and Ageing (NICNAS) Draft Report Says Current Risk Estimates Do Not Indicate a Health Concern from Exposure of Children to DINP in Toys
Phthalates Not Detected in Food Packaging Migration Tests
HP Panel-Sponsored Presentation at ARA Workshop Well Received by Risk Assessment Experts
HP Panel Joins ARASP
ACC Highlights Misinformation in The New York Times Article on Endocrine Disruptors
ACC Highlights CPSC Commissioner Nord's Call to Return to Looking at Risk and Reasonableness
ACC Advocacy "LEEDs" to Success
ACC-Sponsored Critique of the European Commission "State of the Art Assessment of Endocrine Disruptors" Sheds Light on Weaknesses of the Report
News
Consumer Product Safety Commission (CPSC) Chronic Hazard Advisory Panel (CHAP) on Phthalates Report Delayed
The High Phthalates (HP) Panel is closely following the CPSC CHAP on Phthalates as it examines phthalates and phthalate alternatives pursuant to the Consumer Product Safety Improvement Act of 2008 (CPSIA). The Panel wrote to the CHAP in January 2012 to urge that any recommendations to the CPSC must be scientifically based and grounded in a risk-based approach that considers previous reviews by regulatory bodies in the United States and Europe, that considers exposure and the weight of the evidence, that examines all alternatives, including other phthalates, and that clearly sets forth the scientific justification for each of its conclusions. A previous CHAP review of DINP in 2001 found that for most children, exposure to DINP from DINP-containing toys would be expected to pose a minimal to non-existent risk of injury. The CHAP report, which was originally expected in April of this year, will likely be issued in late summer or fall.
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EPA Design for the Environment (DfE) Proceeds with Evaluation of Phthalates and Phthalate Alternatives
As part of the Phthalates Action Plan, the DfE Alternatives to Certain Phthalates Partnership will evaluate the eight chemicals identified in the Plan, and known and potential functional, application-based plasticizers and solvents (including other phthalates). The HP Panel, along with other stakeholders on the Steering Committee, helped to develop the goal and scope of the project, which goal is "to inform substitution to safer alternatives for certain phthalates by evaluating the hazard associated with functional alternatives, and to provide other relevant information pertaining to alternatives assessment, in keeping with DfE principles, making this information available to decision-makers and the public." EPA has stated that the assessment will also capture basic information about known and potential functional use and applications using phthalates or alternatives, and to the extent that this information is available, technical and performance attributes, technical feasibility, commercial availability, and relative cost. The HP Panel will continue to encourage EPA to include consideration of exposure, and to include current application information for each phthalate, the specific tests used to evaluate the plasticizer performance in the application, and the efficiency of the replacement chemical in formulating a similar compound with the needed performance properties. Without these attributes, a report will be of little practical use. The next step is to finalize the list of alternatives and collect information on uses and applications. Once EPA has the finalized list of alternatives it will convene a hazard committee to track progress on the development of the hazard profiles for each chemical, and commence with the hazard evaluations. A draft for review is expected by the summer of 2013. To add your voice to this process, please contact Cal Baier-Anderson.
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European Chemicals Agency Rejects Danish Proposal to Restrict Four Phthalates under REACH
The Committee for Risk Assessment (RAC) of the European Chemicals Agency (ECHA) has concluded that the proposed restriction of four classified phthalates (DEHP, DBP, BBP, and DIBP) in articles is not justified. In 2011, the Danish authorities made a restriction proposal with the aim of limiting exposure to humans from the four phthalates in consumer articles. At its meeting in June, the RAC concluded that the available data does not indicate that there is a current risk from combined exposure to the four phthalates. In addition, RAC said it believed that the existing regulatory measures and the consequential reduction in use would further reduce exposure. The members of RAC are appointed by the ECHA Management Board. The RAC prepares the opinions of ECHA related to the risks of substances to human health and the environment in certain REACH and CLP processes. The final decisions are taken by the European Commission through a regulatory committee procedure. » View the ECHA press release
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EPA to Explore Use of Section 6 of TSCA
Jim Jones, EPA's acting assistant administrator for chemical safety and pollution prevention, told state officials attending the Environmental Council of the States "State Environmental Protection in 2012" forum that EPA will explore the use of TSCA Section 6 authority for the first time in decades. Jones referred to Section 6 of TSCA, which provides the authority for EPA to ban or restrict chemicals. Section 6 requires that EPA prove it has substantial evidence that a chemical poses an unreasonable risk before it can ban, restrict, or take other actions to manage that risk. The section also requires that EPA use the least burdensome means to adequately protect against the unreasonable risk. EPA has not sought to use its Section 6 authority since 1991, when the U.S. Court of Appeals for the Fifth Circuit overturned the agency's attempt to ban asbestos (Corrosion Proof Fittings v. EPA, 947 F.2d 1201 (5th Cir. 1991)). For further information, see BNA Daily Environment Report June 8, 2012.
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ECHA Draft Report on DINP and DIDP Toy Restrictions States that No Further Risk Reduction Methods are Necessary
The ECHA draft review report entitled Evaluation of New Scientific Evidence Concerning DINP and DIDP in Relation to Entry 52 of Annex XVII to Regulation (EC) No 1907/2006 (REACH) concludes the existing restriction on DINP and DIDP in toys and childcare articles which can be placed in the mouth by children is justified (restriction entry 52 in Annex XVII to REACH). However, the report also concludes that "no risk is expected from combined exposure to DINP and DIDP for children exposed via food and the indoor environment. Based on the risk assessment in this report, it can be concluded that no further risk management measures are needed to reduce the exposure of children to DINP and DIDP." » View the report [document size is large—will take a moment to load]
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Australian Government Department of Health and Ageing (NICNAS) Draft Report Says Current Risk Estimates Do Not Indicate a Health Concern from Exposure of Children to DINP in Toys
The Australian government's Department of Health and Ageing (NICNAS) has released its Priority Existing Chemical Draft Assessment Report on Diisononyl Phthalate (DINP), finding that "[c]urrent risk estimates do not indicate a health concern from exposure of children to DINP in toys and child care articles even at the highest (reasonable worst case) exposure scenario considered." Furthermore, the report notes that "[t]he risks from cumulative exposure of children to DINP in toys and child care articles with or without DEHP at maximum one percent together with co-exposure to DEP in cosmetics at maximum 0.5% in body lotions have been considered and found to be acceptable based on current public health risk management measures." The report concludes that "no additional recommendations to the existing controls in place for the public health risk management for the use of DINP in toys and child care articles are required." The report notes that there are interim or permanent restrictions in the EU, the US and Canada on the use of DINP in toys and child care articles that can be placed in the mouth by children, but there are currently no restrictions on the use of DINP in toys and child care articles in Australia. » View the draft report.
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Phthalates Not Detected in Food Packaging Migration Tests
Food Standards Australia New Zealand (FSANZ) has published results from a 2010 survey of the migration of chemicals from food packaging indicating that certain chemicals, including phthalates, perfluorinated compounds (PFCs) and vinyl chloride, were not detected in food samples.The survey analyzed 65 foods and beverages packaged in a range of materials including plastic and cans. » Learn more
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Panel Activities
HP Panel-Sponsored Presentation at ARA Workshop Well Received by Risk Assessment Experts
The HP Panel sponsored a presentation by Dr. Christopher Borgert at the Alliance for Risk Assessment (ARA) workshop entitled Beyond Science and Decisions: From Problem Formulation to Dose-Response Assessment on May 24, 2012 at the Texas Commission on Environmental Quality. The workshop is one in a series designed to advance the recommendations of the National Academy of Sciences' (NAS) Science and Decisions: Advancement of Risk Assessment (2009) report and the subsequent ARA framework. The ultimate goal is to achieve consensus among the participants on considerations for applying dose-response techniques for common risk assessment applications.
Dr. Borgert's presentation, The Human Relevant Potency Threshold: Reducing Uncertainty by Human Calibration of Cumulative Risk Assessments, presented an alternative approach to the conservative Dose Addition-Common Adverse Outcomes (DA-CAOS) concept in cumulative risk assessments. The presentation was vetted by a science panel of risk assessment experts from academia, industry, and government agencies. » View the presentation
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HP Panel Joins ARASP
During its March meeting, the HP Panel approved participation in ACC's Center for Advancing Risk Assessment Science and Policy (ARASP). ARASP is a coalition of independent, self-funded groups housed under ACC's Chemical Products and Technology Division through which industry promotes the development and application of up-to-date, scientifically sound methods for conducting risk assessments. ARASP's diverse membership includes organizations engaged in the business of chemistry, the oil and natural gas industry, and crop protection and plant science. The benefits of ARASP membership include engagement with the regulatory community on approaches to improve risk assessment science and policy and platforms for advocacy and key collaboration in leading industry engagement on risk assessment science and policy issues. Through this collaborative composition and efforts, ARASP offers the Panel the opportunity to engage in activities to promote the use of advanced scientific approaches. Engaging in such activities ultimately helps the Panel to advocate against legislation, regulation and de-selection that is not based on the best available scientific information.
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ACC Activities
ACC Highlights Misinformation in The New York Times Article on Endocrine Disruptors
ACC's Senior Toxicologist Rick Becker commented on the misinformation in The New York Times article entitled "How Chemicals Affect Us" including the author's failure to define "endocrine disruptor" and the author's decision to uncritically accept the alarms of some in the scientific community, and then amplify them through his own uninformed endorsement, without first asking whether there is broad scientific consensus in support of these claims. » View the blog post
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ACC Highlights CPSC Commissioner Nord's Call to Return to Looking at Risk and Reasonableness
Commissioner Nancy Nord of the U.S. Consumer Product Safety Commission (CPSC) says it is time to discard the precautionary principle at the CPSC and return to the historical practice of "looking at risk and exposure to assess a risk's reasonableness before adopting safety standards or banning products." » View the blog post and Commissioner Nord's statement
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ACC Advocacy "LEEDs" to Success
ACC continues its policymaker and value chain outreach and education concerning certain proposed chemical avoidance credits. So far more than 75 Congressional briefings have been held, helping ACC secure a bi-partisan House letter signed by 56 Members. The letter was sent to the General Services Administration (GSA) and highlights LEED 2012's potential to threaten jobs and increase building costs at a time when our fragile economy can least afford it. It also urges GSA to stop using the LEED rating system if USGBC does not remove the provisions. ACC is pursuing a similar letter in the Senate. ACC efforts have also produced more than 70 letters from state and local officials, including Gov. Synder (R-MI), that express concern directly to USGBC about the proposed credit rating system. ACC's efforts are paying dividends. Not only were modest improvements made to the fourth draft, but notably, USGBC has delayed its balloting on the proposal to June 1, 2013, and LEED 2012 has been renamed LEED v4. A fifth public comment period will run from October 2, 2012 through December 10, 2012. » Learn more
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ACC-Sponsored Critique of the European Commission "State of the Art Assessment of Endocrine Disruptors" Sheds Light on Weaknesses of the Report
ACC sponsored a review article critiquing the European Commission "State of the Art Assessment of Endocrine Disrupters" (SOA), which review article was recently published in Critical Reviews in Toxicology. The review article found that the January 2012 SOA falls well short of what is required to build on the 2002 WHO/IPCS survey and evaluation titled "Global Assessment of the State-of-the-Science of Endocrine Disruptors." The SOA assessment takes an anecdotal approach rather than attempting a comprehensive assessment of the state of the art or synthesis of current knowledge. For example, the Assessment failed to distinguish between apparent associations of outcomes with exposure and the inference of an endocrine disruption (ED) basis for those outcomes; failed to constitute a complete and unbiased survey of new literature since 2002; failed to consider strengths and weaknesses and issues in interpretation of the cited literature; and failed to document the evidence for its conclusions or the reasoning behind them. These failures are of concern, as a number of notable and highly visible scientific debates that are current in the field are not characterized and in some cases not even noted. Yet, the spectrum of opinion and the evidence supporting different views are a part of the state of the science. » View the review article
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