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EPA's Dioxin Reassessment: Comments and
Questions by the Public Health Policy Advisory Board John D. Millar, M.D. Coming up at this late hour of the day has good news and bad news. The good news is that all the important concepts have already been introduced. The bad news is that all the good concepts have already been introduced. I will try to find a little something here and there that is original. I am delighted to be here today to speak on behalf of former Secretary of Health and Human Services, the Honorable Louis W. Sullivan, who is the founder and chairman of the Public Health Policy Advisory Board, or PHAB, as we call it. I thank Dr. Charnley and also John Cohrssen, our Executive Director, for help in preparing my remarks, but the obstreperous parts are all mine. Back in those quaint old days of the 1980s, when the Soviet Union and the United States glared at each other across the iron curtain, Ralph Peters wrote a novel called Red Army. In it, the Soviet Union launches an all-out, high tech surprise attack on Western Europe. In the headquarters bunker, moments before launching World War III, the Soviet commander says quietly to his aide, "Modern warfare is not merely a brawl. It is both a broad science and an uncompromising art. If you have not asked yourself every possible question, the unasked question will destroy you." I am here today on behalf of PHAB to ask questions about EPA's reassessment of dioxin. I doubt that I qualify, as many here do, as a dioxin insider, but neither risk assessment nor dioxin are entirely foreign to me. As director of NIOSH from 1981 to 1993, I chaired the Public Health Service subcommittee on environmental health risk assessment. Also, while I was director of NIOSH, the institute published important epidemiological findings on dioxin, including the Fingerhut study, which you have heard about already today. In fact, my signature is very conspicuous on this NIOSH current intelligence bulletin, in 1984, which, on the basis of the OSHA carcinogen policy and the results of studies in animals, recommended that "dioxin be regarded as a potential occupational carcinogen and that occupational exposures to dioxin be controlled to the fullest extent feasible." But, first, a word about PHAB. We are a non-profit, tax exempt public policy organization established by Dr. Sullivan in 1998, to improve public health policy through sound science-based policy making. We are concerned about alarmist reports of speculative dangers, especially to children, that distract our society from the known real dangers. Strident claims and counterclaims obscure the facts, confuse the public and distort the allocation of scarce public health resources. In keeping with our mission, PHAB published, in 1999, this study entitled, Health and the American Child, a Focus on Mortality Among Children. Our goal was to explore the current trends of causes of death in children. We also identified important contributing risk factors, pertinent interventions and expenditures for children's health. We found some very interesting things. First, American children in the 1990s were healthier than at any time in recorded history. Mortality rates for all children dropped over 90 percent during the 20th Century. Children, in particular, benefited from advances in public health, medicine and social policy. Second, on page 23 of this document, we note that five causes of death account for three fourths of the mortality in children. Those five, in descending order are, unintentional injuries, homicides, suicides, cancer and congenital anomalies. The four major risk factors for those deaths, which are shown on page 49 of the document, are alcohol, motor vehicles, drugs and firearms. By comparison, toxic agents in the environment, and deficiencies in medical care, both of which preoccupy national attention, are much less important in childhood mortality. The contribution of environmental toxins is not known, but our risk factor analysis estimated the total at about one percent. You will find that on page 49. The role of dioxin in that one percent, if any, is unknown. When I got into this matter with the EPA dioxin reassessment, I had hoped that it would give me a better understanding of that. It did not. In fact, I got no sense of the actual threat of dioxin to the public health. EPA says its reassessment is intended to provide "a concise statement of dioxin science and the public health implications of general population exposures…" I wondered, why do they want me to know the science on dioxin? What are the public health implications?. Does EPA consider dioxin a leading public health threat? If so, why? What diseases or injuries are we seeing that move us to focus on dioxin? Thus, the first question about the reassessment that I pose to you is, "What public health problem are we trying to solve with this reassessment?" Maybe we at PHAB have missed something. It seems to us that there is no context for this reassessment. If, as Dr. Charnley mentioned, the reassessment has some risk management goal, it seems unknown or at least unrevealed. Instead of starting with a public health problem and proceeding to solve it, it seems as though EPA started with a chemical and is promoting concern about a potential problem without a proposed solution. The most alarmist aspect of the publicity surrounding the reassessment is the assertion by EPA that "dioxin may be more harmful than previously thought." This is guaranteed to jangle the nerves of conscientious people, especially parents and grandparents. Yet, this ambiguous assertion seems to be based on studies -- as you have heard all day long -- of highly-exposed workers, not the general population. Therefore, my next question about the reassessment is this. "How science-based is the assertion that dioxin is worse than we thought?" Everybody who has done any occupational and environmental epidemiology knows three things about cohorts of workers: One, workers are exposed "first" and "worst" to chemical toxins. The dioxin cohorts from which the human data derive, with the exception of Seveso, are highly exposed workers, exposed either in contaminated production processes (including run-away reactions and industrial accidents), or in applications of contaminated chemicals. Two, workers are invariably exposed to a variety of chemicals, making it impossible, in my judgment to attribute observed effects in them specifically to a single agent, such as dioxin. Third, the route of exposure for workers is clearly different from that for the general population. Therefore, as important as they are for occupational considerations, the occupational studies may have no relevance to exposures of the general population, especially children. To their great credit, the authors of the Becher 1998 risk assessment said that. I quote: "It must be noted that, with our data, it is not possible to address the effect of dioxin in childhood." Admirable scientific honesty. Providing no public health context, making frightening assertions on dubious scientific grounds, the dioxin reassessment also sends confusing messages that you have heard previously today. The risk characterization tells me that the risk to the general population of excess cancers from dioxin may be as high as one in a hundred, and that the primary source of dioxin exposure is food, including -- alarmingly -- breast milk. The reassessment also tells us that the food supply is safe and that mothers should breast feed their babies. Both can't be true. Thus, my third question is, "What is the truth about dioxin and food, especially breast milk?" One useful thing the dioxin reassessment tells me is that dioxin in the environment and the body burden of dioxin have decreased dramatically and will continue to do so. Apparently, EPA's current regulations and industry's current practices have had their desired effects and reduced exposures to dioxin. Given that, as a public health professional, I am left to wonder, just what are EPA's goals for dioxin? Does EPA want to eliminate dioxin from the environment, to eliminate sources of dioxin pollution, to eliminate body burdens of dioxin, to prevent dioxin-related disease? Each of these goals suggest a different approach and it would help us all if EPA clarified its goal and showed us how this reassessment is supposed to serve them. In the old days, again, of the 1980s when I chaired the public health policy subcommittee on environmental health risk assessment, we knew that quantitative estimates of risk are useful, but not definitive. We also knew that they were subject to several types of mischief. In response, the Public Health Service had a risk assessment philosophy based on establishing the appropriate context. We called it the Brandt document, because it was best articulated by Dr. Edward M. Brandt, then assistant secretary for health, while he was preparing for a hearing before Congress on EPA regulation of pesticides. In the hearing he said: "Within the Public Health Service, we will use risk assessment as a tool to improve our understanding and to help us make prudent recommendations, but we will consider it only in relation to all other information available to us." In terms of what you have heard today, I would assume that that means all possible risk scenarios that are enabled by the available data. The whole picture must be considered. EPA's dioxin reassessment seems to exist in a public health vacuum, raising more questions than it answers. As a long-term Public Health Service officer, I came here with an open mind, willing to believe that EPA's apparent truculence on the issue of dioxin was the legitimate caution of a conscientious fiduciary agency confronted with scientific controversy. Having sat here all day and listened to a series of excellent scientific presentations, the science doesn't seem all that conflicted to me. I am left to wonder, perhaps irreverently -- forgive me, it is late -- "Does EPA really care what the science says?" Conclusion: For our twilight years, my spouse and I are building a new house in North Georgia next to our son. It will be all on one floor, wheelchair-friendly and, if I may say so, lovely to look at. We hope to live out our lives there with family nearby. But…we have a problem. We are "getting a lot of cards and letters" warning us about the new government-mandated EPA-approved toilets. We asked our builder, "Can we have one like we have in our old house?" "No way, " he says. "The only way you can get one of those things is to smuggle it over the border in the trunk of your car." Well-meaning colleagues suggested, "Why don't you just steal one of your toilets from your present house and have it reinstalled in your new house?" "No way," says the builder. "If I did that, the feds would shut me down." It looks like we will just have to master that "three-flush protocol" our friends find necessary to make these new things work. Now, there is something very wrong when, to get a toilet like he has been used to, an honest citizen is provoked -- by his government -- to contemplate crime. It just ain't right. Somebody somewhere didn't ask the right questions. It is awfully hard to undo silly, let alone questionable, government mandates. So, let's get this dioxin thing right, okay? |