California's phenomenal growth, more than 5 million in the decade, is related to the environmental desirability and quality of the State. On the second issue that many environmental decisions revolve around children and that children are inadequately valued in the process, I will give some examples. Perhaps the most egregious was the decision regarding the use of daminozide, or Alar, the growth regulator in apples. Daminozide is a hydrazine compound, one from a class of chemicals well known to be carcinogens, that was first licensed for use on foods in 1963. This systemic pesticide (it permeates the roots, stems, leaves and fruit of plants) enhanced apple production and extended apple shelf life. Over the next twenty years the research world developed much evidence showing the major breakdown product of daminozide, UDMH, to be a carcinogen. In 1985, the president of the American Academy of Pediatrics wrote to the then head of the Environmental Protection Agency (EPA) expressing pediatricians' concern about the continued use of daminozide in food products destined for children. Yet the EPA failed to remove the registration, the license for sale of the product, even though apple products were major constituents of children's diets (as much as 22 times what an adult would consume on a weight basis), and although exposures to cancercausing agents early in life carry greater lifetime risks than late exposures. EPA's failure to act in a health protective manner was due, in part, to a lack of good public or child health input in decisions regarding risks to children. On the EPA advisory committee that met to evaluate daminozide in 1985 there was no one with child health expertise, no one with public health training or focus. Clearly children were shortchanged in this advisory committee's recommendation to allow continued sale of the product until ironclad proof was provided that the UDMH was a cancer-causing agent, at which time in 1989 daminozide was removed from sale. The consumer fear and economic chaos for the apple industry that occurred with daminozide could have been prevented in 1985 with an orderly phasing out of daminozide. If EPA had acted in concert with the Academy's request, children would have been spared four or more years of exposure to an involuntary and unnecessary hazard. A second example of an environmental chemical which I think presents an unacceptable risk to children and other consumers is the pesticide aldicarb. Aldicarb is used on many crops to control insects and other crop destroying pests. It is very effective: it is extremely toxic, it is systemic, and it is durable. When I say it is toxic: the LD50 is about 1 mg per kilogram body weight, which means it is approximately 1000 times as powerful as malathion. A drop of the concentrated material would be lethal to a child. Being systemic, like daminozide it penetrates the entire plant and cannot be washed off. Because of these characteristics, aldicarb has been misused: the most dramatic episode occurring here in California, where more than 1000 people were made ill from eating watermelons illegally contaminated with the chemical. Our investigation of that episode led to the discovery that the threshold for aldicarb's toxic effects was even lower than that predicted by the study the manufacturer performed when it dosed its own volunteer employees with the chemical. Aldicarb has contaminated underground aquifers, particularly in shallow sandy areas, such as the potato growing areas of Long Island and Wisconsin. It remains in ground water for long periods of time; the contamination discovered in Long Island in the early 1970's continues today, despite local cessation of use of the product. Aldicarb is acutely toxic, the symptoms of illness come on quickly. These symptoms, which include headache, nausea, vomiting, diarrhea, excess urination, visual and other neurological symptoms; are extremely difficult to distinguish from other signs of childhood illness. Because aldicarb is applied to a field by mixing a granular formulation into the soil, it is inevitable that some potatoes in a field would be found to have high levels of the compound. Under plausible worst case estimates, a child eating one contaminated potato could be exposed to a dose that was one tenth the dose adequate to kill one half of a test animal population -- clearly an inadequate margin of safety. The Academy of Pediatrics Committee on Environmental Hazards has expressed its concern about the hazard of aldicarb to children consuming these potatoes and about the manufacturer's merely temporary suspension of this use. With the Select Committee's permission, I would like to enter into the hearing record the American Academy of Pediatrics' letter to the EPA on aldicarb in potatoes. Fortunately, under direction from the Congress, the EPA has commissioned a study by the National Academy of Sciences to examine the safety of legal residues in food and also to examine whether children are exposed to excessive levels of this class of chemicals (cholinesterase inhibitors) throughout their environment. That report is due out next year. There are many other examples where children are at the pivot of environmental decision making: Ultraviolet light damage to the skin results in skin cancer. Recent studies show that the risks of skin cancer, particularly the most dangerous, malignant melanoma, is most closely related to the amount of sun damage the skin sustains during the first 18 years of life. The Select Committee is well aware that a number of man-made agents are the cause of ozone layer depletion and the potential for increased UV exposure on earth. As a result of One example where the well-being of children was accorded appropriate weight was the tightening of the California standard for ambient ozone. This major component of Smog has been linked to increases in bronchospasm, wheezing and asthma symptoms in children. research into the effects of ozone in children, the Resources Board has recently promulgated a more stringent One Hour Air Standard for Ozone Air Pollution in California, which is 0.09 ppm. The current Federal standard is 0.12 ppm. There are many other examples where children are the most sensitive portion of the population, as with lifetime cancer risks or with lead, or the most highly exposed, as with pesticides in foods. I am available to discuss these as the Committee chooses. My third point is that while prevention still fights to be part of mainstream medicine, pediatricians must be, and are, the practitioners most aware that it is more effective to prevent disease rather than to treat. We are heartened to see leadership in the environmental area coming from the Public Health Service, particularly the Centers For Disease Control and the Agency For Toxic Substances And Disease Registry. My comments about Alar and aldicarb reflect that environmental regulators need more public health and pediatric input. The Academy of Pediatrics has sought to make children's environments safer and healthier, often in direct ways such as efforts towards reducing tobacco, auto or bike trauma, occupational, or lead hazards. The Academy has also been in the forefront in offering common sense leadership on issues such as ozone air pollution or pesticides such as Alar. In many situations clinicians can make major contributions, as investigators, as educators, and as advocates. Those of us with the Academy of Pediatrics and the State of California are attempting to alert clinicians through joint training efforts with key federal agencies such as Centers for Disease Control and Agency for Toxic Substances and Disease Registry, such as the training underway today and tomorrow in Berkeley. This training is intended as a pilot project, that is to develop a curriculum usable elsewhere throughout the country. There is still a great need to get more and better training on environmental health into the basic medical curriculum, where it is likely to have its greatest effect. We all know the story of the miners' canaries, their asphyxiation being the warning to the miners of a dangerous environment. If our canaries, our children, are safe then the environment will be fit for us all. It will involve research, that is our investigator role; it will involve caring for them and teaching them, our educator role; but most of all it will involve fighting for them, protecting them, our advocate role. I appreciate the committee allowing me to share my thoughts. May 8, 1986 Mr. Lee Thomas USEPA 401 M Street, SW Washington, DC 20460 Dear Mr. Thomas: on The physicians of the American Academy of Pediatrics are concerned about the continued registration and use of the plant growth regulator daminozide (ALAR (R)) on apples in the United States. The Academy's Committee on Environmental Hazards have reviewed data caminozide and have examined the strength of the cancer bicassays for daminozide and its degradation product, unsymmetrical dimethyl hydrazine (UDMF). Taken individually, none of these studies is definitive, however, the consistent finding of increased rates of cancer in test animals gives no reassurance about the safety of this chemical. As pediatricians we are concerned about the well being of children and are frequently asked by parents which foods are the most healthful and wholesome for children. As a father of young children yourself, you no doubt have observed that apples, applesauce and juice are a significant component of the diets of infants and young children. Young children may experience a higher risk from a carcinogen than adults because exposure early in life would provide a longer period (or greater proportion of the lifespan) from first exposure for developing cancer. In 1975 and in 1980 the Congress, through the FIFRA reauthorization process, randated that adequate health effects studies, including carcinogenicity studies, be done on pesticide products. Daminozide and UDMR have qualitative evidence for carcinogenicity that is now more than 10 years old, and yet the manufacturer appears to have awaited the threat of suspension before instituting new, and one hopes, adequate carcinogenicity studies. During all this time. children consumed apple products containing daminozide and UDMH without the benefit of, at least, an adequate weighing of the risks of the exposure and without personal benefit to any child. The benefits of daminozide appear to accrue entirely to the grower, the risks to the consumer. While a general recall of marketed products with detectable residues may not be warranted, parents should have the option of choosing infant and children's foods that do not contain daminozide and UDMI residues. We request that EPA make specific information available to the Academy and to the public so that we can make informed decisions. Specifically, information as to which apples and processed foods are free of residues would be most useful. In view of the consistently suggestive daminozide cancer data and the unwarranted delays by the manufacturer in instituting its cancer bicassays, despite the long-standing FIFRA requirement, the Academy respectfully requests that EPA suspend continued sale of daminozide. While the cancer risks of past use cannot be negated, continued food residues of a products with seven positive, though non-definite, animal cancer studies offers no benefits and certainly some risks to the health of American children. |