| Sponsored
by: International Society of Regulatory |
PANEL 3 PUBLIC HEALTH POLICY Moderator: C.T. "Kip" Howlett, Jr., Esq. As you can see from the topic of this third panel, we are dealing with the more general issues involved from the EPA dioxin reassessment and with what all this means from a public health policy perspective. Very quickly, there are four items that I would like to address as a context for introducing each of the panelists. Exposure matters, real risk matters, due process matters and consistency matters. With regard to exposure, levels of dioxin and furans in the environment are declining and will continue to decline. They peaked in the 1970s. Currently we are at levels that are similar to pre-World War II levels. With the implementation of the EPA regulations, we will be at pre-industrial revolution levels over the next decade or so. This is important. Not only are the absolute levels going down, but the congener pattern has changed. In 1993, when WHO developed their TDI for dioxins, it was 10 picograms of 2,3,7,8 TCDD, because that was what was in the exposure matrix -- the congener that dominated it. In 1998, when WHO revisited the TDI and updated it and they went from one to four on a TEQ basis, they recognized that 2,3,7,8 was only five to ten percent of that one to four range. That becomes important because 95 percent of the data that is in this risk characterization is data relevant only to 2,3,7,8 TCDD. It makes the TEF chapter important because it is the foundation for characterizing what is actually in the current and future exposure matrix. Body burdens are declining as a result of these reduced levels and natural and reservoir sources are now significant. Municipal incinerators used to be the dominant source in the United States, maybe 6,500 to 7,000 grams per year. As a result of the new EPA standards, they will be down to 12 grams annually. Crematoriums in the United States are a source. They are about 12 grams. Real risk matters. Public efforts should focus on what really matters from a public health improvement perspective. This panel is going to focus on that. I think we have heard, particularly from the last two panels, we may be dealing here with a hypothetical person who has high background level in their body and high exposure. There may be only one or two individuals who fit this situation or maybe they are non-existent, versus what we are trying to characterize in the reassessment to the entire population. I want to spend a minute here on due process, because I think this really matters. EPA's current process for finalizing the reassessment, that is, in the year 2000, stands in stark contrast to what they did in 1994. In 1994, they provided ample opportunity for public review and comment. They provided 120 days for public review and comment on the entire reassessment, at that time, 2,000-plus pages. They held eight days of public meetings throughout the United States, not just in Washington, D.C. and they took both oral and written comments as EPA. They had 39 members of the Science Advisory Board and consultants who met for two days to review the entire reassessment and solicited oral and written comments at that meeting. Oral comments were limited to 10 minutes, but the 10 minutes were not limited to a single organization as a stakeholder who wanted to comment. The SAB issued a detailed and extensive report on its review of the entire reassessment. The report lists numerous recommendations including a recommendation that EPA undertake the necessary changes to the reassessment as soon as possible, in light of the major public health and economic implications of EPA's ultimate conclusions regarding dioxin risk. EPA then undertook revisions to the report. Despite the fact that they expected a quick turnaround, EPA formally released the revised reassessment for review and comment in June of 2000, five years after the SAB issued its critical review. In the intervening five years, there were over 320 new studies that are relevant to the science conclusions and the derived health policies in that report. In chapter 8, the dose-response modeling chapter, it was not subject to the July peer review, even though the SAB in 1994 was very critical of this chapter. Now, EPA has requested public comments and external peer review on only two draft chapters of the reassessment, the new chapter nine, TEFs, and the new Part III, the old chapter nine, which is the risk characterization chapter. The other reassessment chapters, numbering over 3,000 pages, are available for background only, despite the fact that there are numerous changes made, and some of the chapters are entirely new additions to the reassessment. The final draft of this report that is going to the SAB was only available on the internet last Thursday with less than a month before SAB review. There are no public meetings held to solicit public review and comments. Instead, EPA has conducted briefings in the Washington, D.C. area to provide information and they only answered questions. The July peer review was only for Part III, the risk characterization and the new chapter nine TEF chapter. Chapter 8, the all important risk modeling chapter, was excluded. Written public comments were solicited, but the oral presentations were limited to five minutes per interested stakeholder. EPA formally released yet another version of the reassessment less than a month before the SAB review. In the outline for the SAB review, they have indicated there will be 90 minutes of public comment allowed. Now, EPA put 20 critical questions to the peer review panel and the same 20 questions to the SAB. Interested stakeholders will have basically four-and-a-half minutes per question. It will be divided among all the stakeholders. That is not meaningful comment. In the Presidential debates, each candidate got three to four minutes per question with the opportunity for follow on, and there will be three debates. The Presidential election will be held involving all the stakeholders to decide what is the best outcome. In this situation, EPA has largely controlled the science. They have certainly controlled the writing of the report, the interpretation of it, its partial review, and the final release. Adequate due process is not what is happening with regard to this record compared to 1994, and SAB's recommendation to have a thorough and open scientific review in 2000. No Federal Register notice has yet been issued, unless it was out today, and I think the ultimate question here is, does the weight of the science support the health policy characterizing current and future health effects of dioxin exposure. I won't go into the litany of the recent decisions with regard to how well EPA has met its statutory requirements, but there is an extended list of decisions recently overturning EPA decisions that deal with problems, not only with regard to due process, but exceeding their statutory requirements. (See Appendix A.) Finally, I think the other issue here is that consistency matters. Within the United States Government, ASTDR has a minimum risk level of one picogram TEQ. The World Health Organization uses a TDI of one to four picograms. EPA is basically down to either .0002 from .006 picogram, or we may be back up in the range of .001. I think the important thing is that EPA is indicating the WHO TDI as being a risk management number, not a risk assessment number, grossly misrepresents the WHO TDI. I won't read the quotes out of here, but this is the WHO TDI document. If you read both the preface as well as the conclusions, it is very, very clear that this is a risk assessment document. (See Appendix B.) It concludes on the basis of actually providing a 10-fold safety factor to the low observed adverse effect level, which happened to be not the cancer end point but sperm counts in rats. If you look at the 2,3,7,9 TCDD exposure that we currently have and is projected, we are at least at 100-fold safety factor below what the WHO used. The continued trend with regard to exposure is, we are on the pathway between 100 and 1,000-fold safety factor. To paraphrase Winston Churchill, never have so many looked at so much for so long to find so little. |