Welcome to the October 2012 High Phthalates Panel newsletter. We hope this newsletter 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
Australian Government Department of Health and Ageing Final Report on DINP Finds No Health Concerns from Exposure of Children to DINP in Toys and Child Care Articles
Health Canada Kicks Off Phthalates Grouping of the Substance Groupings Initiative
ACC President Seeks Engagement from CPSC Chair Concerning CHAP on Phthalates Process
High Phthalates Panel Presentations at SPI Compounders Conference Well Received
ACC Responds to Claims Regarding Phthalates in School Supplies
ACC Participates in NAS IRIS Review Committee September 17, 2012 Public Session
News
Australian Government Department of Health and Ageing Final Report on DINP Finds No Health Concerns from Exposure of Children to DINP in Toys and Child Care Articles
The Australian government's Department of Health and Ageing has finalized the Priority Existing Chemical Assessment Report on diisononyl phthalate (DINP) under the National Industrial Chemicals Notification and Assessment Scheme (NICNAS). It found 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 stated that "[r]isks from cumulative exposure of children to DINP in toys and child-care articles with or without DEHP at maximum 1% together with co-exposure to DEP in cosmetics at maximum 0.5% in body lotions are considered low, as cumulative MOEs for the three critical health effects identified [liver and kidney toxicity, and reproductive/developmental effects] are all above 100...which indicate an adequate safety margin." "An MOE of greater than 100 in risk characterisation is usually regarded as an indication of low concern as it encompasses the conservative default uncertainty factors of 10 each for intraspecies and interspecies variability."
There are currently no restrictions on the use of DINP in toys and child care articles in Australia. The publication of the final report revokes the declaration of DINP as a priority existing chemical; therefore, manufacturers and importers wishing to introduce the chemical in the future need not apply for assessment. The notification of the completion of the assessment can be found in the September 2012 edition of the NICNAS Chemical Gazette, available here.
View the final assessment report.
View ACC's blog post on the finding.
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Health Canada Kicks Off Phthalates Grouping of the Substance Groupings Initiative
The Existing Substances Risk Assessment Bureau of Health Canada is planning to assess fourteen phthalates as part of the Substance Groupings Initiative of the Chemicals Management Plan (CMP). The information gathering and stakeholder engagement phase for this Substance Grouping was launched with an information session held via webinar on August 1, 2012. Health Canada held a follow-up meeting with stakeholders on September 27, 2012 in Ottawa. Health Canada seeks input from manufacturers and importers into Canada of the substances currently in the Phthalates Grouping. The group description, selection considerations, and list of the fourteen substances that are being considered for inclusion in this group are available here. Health Canada seeks information from manufacturers and importers by early November so they can determine the need for a Section 71 notice.
Health Canada has stated that the scope of this group "may be expanded to inform a cumulative assessment approach if warranted." The High Phthalates Panel will continue to monitor this process and participate in stakeholder discussions.
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Panel Activities
ACC President Seeks Engagement from CPSC Chair Concerning CHAP on Phthalates Process
Cal Dooley, President and CEO of ACC, met on August 23, 2012 with the Chairman of the CPSC, Inez Tenenbaum. Mr. Dooley reiterated the request made in his August 13, 2012 letter to Ms. Tenenbaum that the CPSC arrange an open, transparent peer review that comports with the OMB Bulletin on Peer Review to ensure the transparency and integrity of both the review process and outcome. The review is expected to serve as the scientific underpinning for CPSC rulemaking that could have a significant impact on many industries that produce or use phthalates in products, including flooring, wall coverings, roofing and wire and cable. Additionally, the CPSC review of phthalates could influence chemical management and federal risk assessment policy more broadly in the areas of cumulative risk assessment and endocrine policy. Chairman Tenenbaum stated that her philosophy for the agency was one of transparency, and that the agency was having internal discussions about ACC's request. In addition to Mr. Dooley, David Fischer and Eileen Conneely represented the High Phthalates Panel at the meeting.
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High Phthalates Panel Presentations at SPI Compounders Conference Well Received
The High Phthalates Panel conducted two informational sessions at the SPI Flexible Vinyl Products Division 23rd Annual Compounders Conference in Annapolis, MD on July 17 and 18, 2012. The Compounders Conference brought together a broad range of flexible vinyl stakeholders and offered an extensive program on the state of the vinyl industry as well as innovative products and services.
During the first session, Panel Manager Eileen Conneely provided an overview of the Panel's mission, its advocacy activities, and the current regulatory climate. The session was well received, as was the Panel's follow-up session on July 18, which featured a Question and Answer session with Panel members and discussion of the Panel's focus group research with "informed Americans." The Panel also presented its informational brochures on phthalates, which are available at: http://www.americanchemistry.com/High-Phthalates.
View the SPI presentation.
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ACC Activities
ACC Responds to Claims Regarding Phthalates in School Supplies
In response to a report issued by the Center for Health, Environment and Justice claiming that many vinyl back-to-school products contain high levels of phthalates, the American Chemistry Council released a statement noting that "[t]here is no reliable evidence that phthalates have ever caused any harm to any human in more than fifty years of use." Phthalates are some of the most tested substances in commerce and have been reviewed by multiple regulatory agencies in the United States and Europe, including reviews that specifically examined the presence of phthalates in typical school supplies.
For example, the European Union's Scientific Committee on Health and Environmental Risks (SCHER) released a scientific opinion on phthalates in school supplies which found "that the presence of phthalates in school supplies other than erasers is of low concern since dermal contact may be the only reasonable exposure pathways for children. Exposure from this pathway is expected to be very limited due to limited skin contact and inefficient dermal uptake." Moreover, the report noted that "swallowing of a larger number of particles from an eraser containing DEHP likely represents an infrequent event due the nature of the particles...." The SCHER concluded that "the phthalates in the articles tested do not significantly contribute to the body burden of phthalates in children."
View ACC's statement.
View the SCHER Report.
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ACC Participates in NAS IRIS Review Committee September 17, 2012 Public Session
On September 17, 2012, the National Academy of Sciences (NAS) panel charged with reviewing EPA's Integrated Risk Information System (IRIS) Program held its initial meeting, during which Dr. Kenneth Olden, Director of the National Center for Environmental Assessment (NCEA), and Dr. Vincent Cogliano, Acting Director of IRIS, provided remarks. While Dr. Cogliano noted that EPA is embracing and implementing the NAS recommendations from the 2011 formaldehyde draft IRIS review, Dr. Olden went further to state that it was "a new day" for NCEA and that "openness and transparency will be the hallmark" of the IRIS Program.
Drs. Kimberly Wise and Rick Becker provided oral remarks at the open session portion of the meeting, reiterating written comments ACC previously submitted to the Panel: that EPA's approach to developing IRIS assessments uses the best available scientific information regarding hazard and exposure; employs consistent, objective methods and models; utilizes transparent evaluation procedures for data quality, cause and effect; and weighs the full body of scientific evidence. NAS plans to conduct a weight of evidence workshop in March of 2013. ACC's Center for Advancing Risk Assessment Science and Policy (ARASP) has commissioned a white paper on various weight of evidence frameworks, which is scheduled to be completed this fall, and will hold its own weight of evidence workshop in early December.
ACC will continue to follow and participate in the ongoing review and advocate for significant IRIS improvements to ensure that it is a model of objectivity, transparency, and scientific accuracy.
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