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Phthalate Esters Issues Update

Phthalate Esters Issues Update. Marian Stanley Manager, Phthalate Esters Panel June 8, 2005. Thumbnail Sketch. Founded 30 years ago Self-funded under American Chemistry Council Resources include: ACC staff (2 committed full time; resources from many others) Member company professionals

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Phthalate Esters Issues Update

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  1. Phthalate Esters Issues Update Marian Stanley Manager, Phthalate Esters Panel June 8, 2005

  2. Thumbnail Sketch • Founded 30 years ago • Self-funded under American Chemistry Council • Resources include: • ACC staff (2 committed full time; resources from many others) • Member company professionals • Outside consultants (communications, legal)

  3. Panel Mission • To support the market for Panel products • Aggressively defend the science, facts, benefits • Actively address unwarranted de-selection • Via the use of • Research • Federal, state advocacy • Communications • Global strategic planning & activities • Litigation, if needed

  4. “Plastics Pyramid of Problems” PVC PU, PS, ABS, PC PET PE, PP Biobased Polymers From Greenpeace web site, April 1998

  5. Activist Allegations - Phthalates • Activists oppose PVC, attacking additives • “Toxic Toys” allegations • Allegations of adverse effects/endpoints • Hormonal changes...endocrine disruption • Cancer, fertility effects, developmental changes • Sensitive subpopulations...primarily children • Precautionary Principle • no exposure, no risk, especially for children

  6. Risk-Based Sound Science STAGE 1 STAGE 2 (only if risk exists) Phase 1 Hazard Identification Phase 5 Development and evaluations of risk management options Phase 2 Dose-response assessment Phase 4 Risk characterization Phase 6 Employ risk management; monitor, evaluate Phase 3 Exposure assessment

  7. Phase 5 Development and evaluations of risk management options Phase 6 Employ risk management; monitor, evaluate Implement restrictive measures The “Activists Precautionary Principle” STAGE 1 STAGE 2 (only if risk exists) Phase 1 Hazard Identification Assume risk exists Phase 2 Dose-response assessment Phase 4 Risk characterization Phase 3 Exposure assessment

  8. US Phthalate Regulatory Strategy • Science-based Advocacy to Prevent Unwarranted Regulation • Regulation Consistent with Scientific Evidence • Proactive Outreach to Regulatory Agencies when Appropriate • Proactive Outreach with Individual State Legislation

  9. EU Regulatory Reality • Risk Assessments for phthalates nearly complete • REACH may place a large burden on industry • Classification and Labeling is hazard based and often does not agree with risk assessments

  10. Significant ConclusionsImpacting Panel Products Recent reviews indicate little or no concern

  11. Building Guidelines • Green Guidelines for Healthcare Construction • USGBC PVC Task Group – report finds vinyl as good as other materials

  12. Rodent Liver Cancer Background • Initial observations published in late ’70s • Early assessments concluded “possibly relevant to humans” • Subsequent information indicated human risks unlikely, leading to… • Conclusions by IARC, Health Canada and the EU that rodent liver cancer caused by phthalates was not relevant to humans • US regulatory authorities have been cautious about changing regulatory classification of DEHP

  13. Rodent Liver Cancer – Current Status • New toxicology information provides better understanding of “mode of action” • Mechanistic data indicates “mode of action” unlikely in humans • EPA asked ILSI to review data and make recommendations for risk assessment • Overall conclusion (and advice to EPA) • “…Liver tumorigenesis in the rodent is not likely to occur in humans…” • Applies to DEHP and DINP

  14. Reproductive Effects Background • In early studies some phthalates affected fertility, testicular weights in rats • Risk assessments by CERHR generally conclude minimal risks to humans in most circumstances • CERHR identified “critical data needs”

  15. Reproductive Effects - Current Status • Recent industry research has focused on relevance to humans • No testicular effects in marmosets even at high doses • Suggests effects are “rodent specific” • Underlying mechanism seems similar to that for liver cancer • If substantiated, shows humans are less sensitive than rodents • New data indicate risks lower than as concluded by CERHR

  16. Potential for Asthma Background • Role of phthalates in childhood asthma proposed in ’97 • Experts judged association unlikely • Research program launched to directly test hypothesis • “Phase I” results suggest phthalates do not produce respiratory allergy • “Phase II” results suggest early claims about phthalate effects are unreliable

  17. Phthalate Exposure Biomonitoring • Early exposure estimates suggested widespread, but very low exposures • Urinary biomonitoring provides more precise exposure estimates • New data show exposures similar or lower than estimates used by CERHR • Support conclusion that exposures ( and  risks) to general population are very low • Current research program aimed at addressing uncertainties in calculations

  18. Environmental Issues • PBTs and POPs • Substantial evidence of biodilution • Phthalates not on EPA PBT list • Handbook of Environmental Chemistry published

  19. Communications Goals and Strategy • Goal: minimize unwarranted product de-selection • Strategy • Emphasize benefits messages • Show phthalates do not present a human health concern • Use aggressive, targeted outreach to show accurate picture in the print/broadcast media • Support downstream users • Be open, forthright, transparent • Emphasize global consistency, effectiveness

  20. Media Proactive Approach • Panel statements – posted or standby • Selectively proactive with media to push the good news about CPSC, CERHR, CDC, ILSI, EU Risk Assessments • Preemptive news release touting CPSC decision • Let no incorrect news report go unchallenged • ~ 30 letters to the media in the past year • But, keep the profile low – the best ink is no ink

  21. Phthalate Benefits • Long history of use, strong safety record • Phthalates extremely well-studied • Impart flexibility to PVC • Wall coverings, flooring, packaging, medical products, toys • Wide variety of consumer products • Provide durability • Paints, nail polish • Act as solvent, fixative • Fragrances, cosmetics

  22. Conclusions • Activist opposition based on misinformation, emotion and over interpretation of preliminary test results • Sound science-based advocacy is working • Phthalates can be used safely in their current applications • Research is continuing to support these products

  23. For More Information - www.phthalates.org

  24. Thank you for the time Questions?

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