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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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phthalate esters issues update

Phthalate Esters Issues Update

Marian Stanley

Manager, Phthalate Esters Panel

June 8, 2005

thumbnail sketch
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)
panel mission
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
plastics pyramid of problems
“Plastics Pyramid of Problems”

PVC

PU, PS, ABS, PC

PET

PE, PP

Biobased Polymers

From Greenpeace web site, April 1998

activist allegations phthalates
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
slide6

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

slide7

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

us phthalate regulatory strategy
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
eu regulatory reality
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
significant conclusions impacting panel products
Significant ConclusionsImpacting Panel Products

Recent reviews indicate little or no concern

building guidelines
Building Guidelines
  • Green Guidelines for Healthcare Construction
  • USGBC PVC Task Group – report finds vinyl as good as other materials
rodent liver cancer background
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
rodent liver cancer current status
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
reproductive effects background
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”
reproductive effects current status
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
potential for asthma background
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
phthalate exposure biomonitoring
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
environmental issues
Environmental Issues
  • PBTs and POPs
    • Substantial evidence of biodilution
    • Phthalates not on EPA PBT list
  • Handbook of Environmental Chemistry published
communications goals and strategy
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
media proactive approach
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
slide21

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
slide22

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