North Carolina Polyurethane Foam Industry

1. North Carolina Polyurethane Foam Industry • Critical component in U.S. furniture and bedding • 7 Foam manufacturers in North Carolina: • Produce about 2 billion board feet of cushioning product per year(1) • Support about 25 large NC foam fabricating distributors • Provide about 4000 NC foam manufacturing and fabrication jobs(2) • (1) Estimated from NC PFA member reports • (2) SPI Plastics Industry Jobs Survey

2. ATSDR / NC DHHS Health Study • Looking for TDI emissions and possible respiratory health problems around plants. • Three simultaneous separate activities • Personal health interviews • Air monitoring • Blood sampling • No way to relate findings from the health interviews, to air monitoring or blood tests • Only unrelated raw data will result • No way to accurately tell participants, health care providers, or community residents what any findings mean

3. North Carolina Foam Manufacturers • Operate under the tightest TDI emission standard in the United States • Take pride in zero NC air quality violations • Focused on safety for workers and the community • No confirmed cases in foam plants of TDI worker sensitization or TDI-caused occupational asthma in 20 years

4. No Problems, No Complaints • There were no public requests for ATSDR to conduct a community TDI study.  • ATSDR agrees the reason for the study is a 9-year old isolated incident that may not apply to existing NC foam producers.

5. Possible Tipping Point • Chinese upholstered furniture imports are relatively new and growing at a fast rate. • The foam business lost 14% of its volume in the last 6 months. • It has been shown that a TDI issue can be a tipping point. • A temporary TDI shortage in 2005 encouraged a rapid shift to Chinese furniture manufacturing suppliers.

6. According to a 1968 study of 26 workers in a TDI production facility (TDI workers), the sensitization rate was 19.4%. (Worst case among 10 separate studies.)(1) Among workers in foam plants, the worst case sensitization rate was 5.6% in 1956.(2) However, in studies made within the past 25 years, the sensitization rate was 0 to 0.6%.(3) Critique of ATSDR Comments (white slides) Old data (1) Bruckner, 1968 [massive spill exposure] (2) Woodbury, 1956 [26 workers exposed to frequent spills] (3) Belin, 1983 [0%], Lee-Phoon, 1992 [0%], Jones, 1992 [0.3%], Clark, 1998 [0.6%]

7. More facts • Regarding air emissions studies in Glenola, NC • TDI was never found in the air.(4) Air sampling was limited to measurement of total VOCs. While it is possible that trace amounts of TDI may have been included in the 29 ppb total VOC measurements, there is no evidence to support that. • TDI antibodies were found in 9% of the tested residents,(5) consistent with the 10% false positive error factor normally associated with that test procedure. (4) ATSDR, Public Health Advisory Trinity American Corp., Randolph County, North Carolina October 20, 1997 (5) White, Berger-Frank, Middleton, Falk (ATSDR Dir.): Addressing Community Concerns About Asthma and Air Toxins, EHP August, 2002

8. It is extremely unlikely that there is any community exposure to TDI. If TDI sensitization and TDI asthma are not found in the workplace, why would exposure be suspected in the community? ATSDR Director, Henry Falk, wrote in 2002 that the “fundamental first step would be to verify that more people have asthma (or that the asthma is more severe or more frequently aggravated) than would ordinarily be expected.”(5) • This type of comparison survey does not require blood testing. (5) White, Berger-Frank, Middleton, Falk (ATSDR Dir.): Addressing Community Concerns About Asthma and Air Toxins, EHP August, 2002

9. Please note that comparison communities are supposed to be located within the same county as the target communities. • Some of the comparison communities are not in the same counties as the target sites. Gastonia is not in Catawba County, nor is High Point in Randolph County. • Outdated and inaccurate TDI emissions data are being used. Radicispandex is now a warehouse distribution center without any emissions, and Crompton (now Chemtura Corporation) emits less than 1 pound of TDI per year. These types of serious oversights are harbingers of future problems in study management, data collection and study control procedures.

10. The first step should be a survey to determine the rate of diagnosed asthma among community residents near possible TDI emissions sources, with comparison work in control communities. • If the rate of diagnosed asthma is significantly higher or the asthma is more severe in target areas compared to control communities, then additional study is needed.

11. The Health Study Presents Challenges • A large error factor in TDI antibody testing is anticipated – more than 10%(6) • How will the study team explain false positive findings to participants and their healthcare providers particularly within control communities? • How will health care providers be educated on the meaning of TDI antibodies and their possible affect on future health? • In fact, there is no direct correlation between testing positive for TDI antibodies and having any health problems. (6) Bernstein, Ott, Woolhiser, Lummus, Graham: Evaluation of Antibody Binding to Diisocyanate Protein Conjugates in the General Population, Allergy Journal, Vol. 20, -pending publication

12. Will the predictable rate of false positive antibody findings (10% error factor) be factored into the “no health problems” category? • The study team must educate community healthcare providers BEFORE the study. There has been no plan for this.

13. The Need for Effective Communications Is Well Established – And Not Part of the Plan • Communicating Results, Interpretations, and Uses of Biomonitoring Data to Nonscientists and Safety Professionals, R.V. Kolluru, S.M. Bartell, R.M. Pitblado, and R.S. Stricoff, eds. New York: McGraw Hill. Miles, S., and L.J. Frewer. 2003. Public perception of scientific uncertainty in relation to food hazards. J. Risk Res. 6(3):267-284. Morgan, M.G., and L. Lave. 1990. Ethical considerations in risk communication practice and research. Risk Anal. 10(3):355-358. Morgan, M.G., B. Fischhoff, A. Bostrom, and C.J. Atman. 2002. Risk Communication: A Mental Models Approach. New York: Cambridge University Press. NRC (National Research Council). 1989. Improving Risk Communication. Washington, DC: National Academy Press. NRC (National Research Council). 1994. Science and Judgment in Risk Assessment. Washington, DC: National Academy Press. NRC (National Research Council). 1997. Building a Foundation for Sound Environmental Decisions. Washington, DC: National Academy Press. NRC (National Research Council). 2004. Adaptive Management for Water Resources Project Planning. Washington, DC: National Academies Press. O'Connor, A.M., F. Légaré, and D. Stacey. 2003. Risk communication in practice: The contribution of decision aids. BMJ 327(7417):736-740. Osterloh, J. 2005. Biomonitoring: Attributes and Applications. Presentation at the First Meeting on Human Biomonitoring of Environmental Toxicants, March 21, 2005, Washington, DC. Otway, H., and B. Wynne. 1989. Risk communication: Paradigm and paradox. Risk Anal. 9(2):141-145. Paling, J. 2003. Strategies to help patients understand risks. BMJ 327(7417):745-748. PCCRARM (Presidential/Congressional Commission on Risk Assessment and Risk Management). 1997. Risk Assessment and Risk Management in Regulatory Decision-Making. Final Report. Washington, DC: U.S. General Printing Office [online]. Available: http://www.riskworld.com/Nreports/1997/risk-rpt/ volume2/pdf/v2epa.PDF [accessed Dec. 1, 2005]. Pflugh, K.K., J.A. Shaw, and B.B. Johnson. 1994. Establishing Dialogue: Planning for Successful Environmental Management; A Guide to Effective Communication Planning. Trenton, NJ: New Jersey Department of Environmental Protection and Energy. Pirkle, J.L., L.L. Needham, and K. Sexton. 1995. Improving exposure assessment by monitoring human tissues for toxic chemicals. J. Expo. Anal. Environ. Epidemiol. 5(3):405-424. Renn, O., T. Webler, and B.B. Johnson. 1991. Public participation in hazard management: The use of citizen panels in the U.S. Risk Issues Health Safety 2(3):197-226. Renn, O., T. Webler, and P. Wiedemann, eds. 1995. Fairness and Competence in Citizen Participation: Evaluating Models for Environmental Discourse. Dordrecht, The Netherlands: Kluwer. Rimer, B.K., and B. Glassman. 1998. Tailoring communications for primary care settings. Methods Inf. Med. 37(2):171-177. Robison, S.H. 2005. Biomonitoring. Presentation at the First Meeting on Human Biomonitoring of Environmental Toxicants, March 21, 2005, Washington, DC. Roth, E., M.G. Morgan, B. Fischhoff, L. Lave, and A. Bostrom. 1990. What do we know about making risk comparisons? Risk Anal. 10(3):375-387. Rowan, K.E. 1994. Why rules for risk communication are not enough: A problem-solving approach to risk communication. Risk Anal. 14(3):365-374. Schober, S. 2005. National Health and Nutrition Examination Survey (NHANES): Environmental Biomonitoring Measures, Interpretation of Results. Presentation at the Second Meeting on Human Biomonitoring of Environmental Toxicants, April 28, 2005, Washington, DC. Schulte, P.A., and G. Talaska. 1995. Validity criteria for the use of biological markers of exposure to chemical agents in environmental epidemiology. Toxicology 101(1-2):73-88. Schwartz, L.M., S. Woloshin, and H.G. Welch. 1999. Risk communication in clinical practice: Putting cancer in context. J. Natl. Cancer Inst. Monogr. 25:124-133. 175

14. PFA would like to improve the science being used in this study. • Air sampling methods are experimental have not been validated with control studies. • Results could be false due to possible interference from incidental diisocyanate emissions sources such as: application of spray foam insulation, applying a floor finish, or touching up some automobile paint. • No work has been done to determine the effective range for detection of incidental emissions. TDI is not uncommon. It is an ingredient in many paints, floor coatings, furniture finishes, aerosol insulation, and pick-up truck bed liners

15. The American Chemistry Council’s Responsible Care outreach panel Would also like to improve the science of this study • The American Chemistry Council (ACC) Chemstar group of physicians, toxicologists, and hygienists worked with ATSDR for more than 2 years. • The Panel’s suggestions to help improve the science have not yet been implemented.

16. More study concerns: • Out-of-date EPA emissions data is being used. • The air sampling technology is experimental, untested and unproven in the field. • Antibody testing has not been validated for use outside controlled worker study groups. There can be interference by eating radishes or other foods that are rich in isothiocyanates.(6) (6) Bernstein, Ott, Woolhiser, Lummus, Graham: Evaluation of Antibody Binding to Diisocyanate Protein Conjugates in the General Population, Allergy Journal, Vol. 20, -pending publication

17. Critical Communications • Our first and foremost concern is health and safety. U.S. foam plants do not have any cases of TDI-related occupational asthma. • U.S. foam manufacturers have no confirmed cases of TDI sensitization within the past 20 years. • There have been no violations of North Carolina air quality requirements.

18. At the recent Gaston County Board of Health meeting, the ATSDR study team explained that NC DHHS recommended additional research as a result of industry criticism of the Glenola work. • We are concerned about the potential for this project to suffer from many of the same problems as Glenola. It is an ambitious undertaking suffering from a lack of proven testing methods. It is key that the study team pay attention to details such as the fact that the spandex plant noted in the top slide no longer uses TDI. It is now a warehouse distribution center.

19. Conclusion • The study should be begin with a health survey. Before state and federal funds are spent on additional research work, it should be established that there is a public health issue that needs to be addressed. • The study budget needs to be reviewed. We believe that the study is grossly underfunded to accomplish all that is planned. Conducting an initial health study makes common sense and may eliminate the need for additional costly research.