EPA Delays Ban on Cancer-Producing Pesticide Dieldrin

The Environmental Protection Agency has "over-whelming" evidence that the pesticides aldrin and dieldrin cause cancer, but political considerations are preventing the Agency from exercising its legal authority to call an immediate halt to the chemicals' use. One estimate, based on laboratory studies of animals, suggests that if the pesticides are used at present levels for another year to eighteen months, as many as 230,000 new cases of cancer may result. EPA's budget for each fiscal year is subject to review in the Agriculture, Environmental, and Consumer Protection Subcommittee of the House Appropriations Committee, and Subcommittee Chairman Jamie Whitten (D-Miss.) is regarded as the pesticide industry's firmest friend in Congress. In April, EPA raised and then dropped the possibility of issuing an interim ban on the chemicals after a letter from Whitten pointedly notified EPA of his concern over any such action. At the time, EPA's budget for fiscal 1975 had not yet been approved by Whitten's subcommittee. The agency subsequently received more than it had asked for from the subcommittee, although much of the surplus is designated for a project close to Whitten's heart: further testing of DDT to determine whether the chemical, banned in 1972, should be allowed back into use. EPA's budget cleared the full House on June 21 and was sent to the Senate. Less than a week later, EPA withdrew legal challenges to the pesticide 2,4,5-T, stating that it lacked sufficient evidence to support a ban on the chemical.

The Shell Chemical Company, a subsidiary of the Shell Oil Company, is the sole manufacturer of the two pesticides. Through its counsel, William D. Rogers of the prestigious Washington law firm Arnold & Porter, Shell has rejected EPA's request for a voluntary halt in production pending the completing of hearings, now in progress, on the chemical's hazardousness.In a letter to EPA, Rogers declared that a suspension of production, whether undertaken voluntarily or compelled by the Agency, would seriously harm Shell's public image and might delude Americans into believing dieldrin "a more serious cancer threat than cigarettes." Legally, the fact that other known carcinogens may be bought and sold should have little bearing on EPA's authority to ban an unsafe produce. From an ethical standpoint as well, it seems possible to distinguish smoking, an activity engaged in by adults with full awareness of the risks involved, from the case of a pesticide believed to present its greatest danger to infants, who have no control over the high dieldrin content of the milk they drink.

Aldrin and dieldrin have been used for twenty years against a variety of agricultural pests, particularly corn parasites in several midwestern states. Of the two chemicals, aldrin is manufactured in much greater quantity, but once in the environment, it rapidly breaks down into dieldrin, so that the two chemicals are often referred to as "aldrin/dieldrin" or simply as dieldrin. Applied to the soil, the pesticide is extremely persistent. Soybeans grown in a field in which aldrin-treated corn was raised the year before may contain dangerously high levels of dieldrin. The chemical also volatilizes readily and adheres to particulate matter in the air. In one recent experiment, aldrin was marked with radioactive carbon 14 and applied to a field near Fort Worth, Texas. A day and a half later, it was found in the air over Cincinnati. Measurable quantities of dieldrin were found in 85 percent of the 3345 air samples taken by the EPA between 1970 and 1972.

Once taken into an animal's body, whether by ingestion or inhalation, dieldrin is stored in fatty tissues. Carnivores acquire and retain the dieldrin of animals below them in the food chain. Although the substance is toxic, animals can tolerate relatively large quantities without suffering immediate poisoning. A major loss of body weight, however may cause stored dieldrin to emerge [4 ELR 10105] from the fat and re-enter the bloodstream at lethal levels. While data on dieldrin poisoning of wildlife is sketchy, an Interior Department study of bald eagle deaths indicates that more than 10 percent of specimens examined in an eight-year period may have succumbed to dieldrin poisoning. In humans, mobilization of stored dieldrin may be triggered either by a loss of approximately 20 percent of body weight or by severe bodily stress, such as illness or surgery.

Under the Federal Insecticide, Fungicide, and Rodenticide Act, the manufacturer of a pesticide must register the chemical with EPA, and users of the chemical must register the specific purpose for which it is intended. If the agency finds evidence of "unreasonable adverse effects on the environment," it may cancel the registration. The registrant is then entitled to a hearing before an administrative law judge, whose decision may be adopted or rejected by the EPA Administrator. The Administrator's final decision is in turn reviewable in the federal Courts of Appeals. Where the Administrator determines, however, that an "imminent hazard" would result from allowing continued use of a pesticide during the time required for a cancellation proceeding, he is empowered to order its immediate "suspension." A suspension order is comparable to a preliminary injunction, attempting to prevent irreparable harm without itself constituting a decision on the merits of the case. In cases of emergency, a suspension order may issue without a hearing beforehand. Normally, however, the registrant is given five days to request a hearing on the proposed suspension. The statute provides for a prompt hearing and agency decision, and for expedited judicial review in the appropriate court of appeals. An Administrator's final order on the question of suspension is reviewable in the court of appeals, notwithstanding the fact that cancellation proceedings for the same chemical may still be going on.

The structure of the law places EPA in an ambiguous position. On the one hand, its Office of the General Counsel plays an essentially prosecutorial role in arguing the case against a pesticide. The EPA Administrator, on the other hand, must be kept insulated from the adversary process so that if called upon to accept or reject the administrative law judge's ruling, he can decide the case with an open mind. However, the Administrator is also given the power to suspend a chemical's use during the pendency of cancellation hearings, and can only do so after weighing the evidence of the pesticide's hazardousness. In order to guarantee the integrity of his final decision, EPA Administrator Russell Train has delegated the power to issue suspension orders to his duputy, John Quarles.

Late in 1970, the Environmental Defense Fund petitioned for cancellation and suspension of aldrin/dieldrin. In March, 1971, EPA Administrator William Ruckelshaus cancelled the chemical's registration while refusing to suspend its use. That cancellation proceeding is still in progress, more than three years, and 225 million pounds of formulated aldrin/dieldrin, later. EDF appealed the decision on suspension to the U.S. Court of Appeals for the D.C. Circuit, which in May, 1972, remanded the case to the Administrator for a fuller explanation of the reasons for his decision. The next month, Ruckelshaus reaffirmed his decision to cancel, but stated that he was reconsidering whether to suspend certain uses of the pesticide. Shell, eager to avoid any suspension, secured the agreement of the user-registrants to whom it sold the product that they would cease several of the most suspect uses of aldrin/dieldrin, including aerial application, dust formulations, and mothproofing. When the Administrator's final decision was issued in December, 1972, it ordered no suspension of dieldrin or its uses, finding the evidence of possible carcinogenic effect too tentative to warrant such a move.

In October, 1973, after behind-the-scenes efforts to reach a settlement out of court failed, EPA began presenting the evidence against dieldrin in the cancellation proceeding before Administrative Law Judge Herbert Perlman. EPA did not finish setting out its case against dieldrin until mid-March, 1974. The Agency reported that in fiscal year 1973, measurable amounts of dieldrin were found in 96 percent of all meat, fish, and poultry samples, 83 percent of all dairy products, and 88 percent of garden fruits, such as tomatoes and peppers. For several years, human fatty tissue removed during surgery and at autopsy has been analyzed for dieldrin content. In 1970, 96.5 percent of the individuals tested had residues of dieldrin in their tissues. A year later the figure was 99.5 percent. The level of dieldrin in the human fat varied from .01 parts per million to over 15 pp. The average for persons sampled in 1970 was .27 ppm; by 1971, the last year for which figures are available, the level had risen to .29 ppm. By way of comparison, .30 ppm of dieldrin in the fat is the level at which the Department of Agriculture must seize and destroy meat and poultry intended for human consumption.

Children under three years old, and newborns in particular, are thought to be the group in the population most endangered by dieldrin. The pesticide is absorbed through the placental barrier during gestation. In the first three years of life, so much of the infant's diet is milk that a disproportionately high level of dieldrin accumulates in its fatty tissues. There are indications that children of this age are especially susceptible to carcinogens, though the actual malignancy may not appear for many years. Because infants are rarely subjected to surgery or autopsy, data as to the level of dieldrin in their tissues is limited.

Experiments with mice have shown that even at levels as low as .1 ppm in the diet, for periods as short as several weeks, dieldrin causes cancer of the liver, lungs, lymphoid tissue, thyroid, uterus, and mammary glands. Similar results have been observed in three strains of mice and two strains of rats. The chemical also produces multiple birth defects in hamsters and mice. There are as yet no clear indications of dieldrin-induced cancer in humans, [4 ELR 10106] although studies conducted independently in Florida, Hawaii, and New Zealand show a strong correlation between lung cancer and high levels of dieldrin. When this data was presented in the cancellation hearing, Shell argued that the high dieldrin levels were the result of the emaciation produced by the cancer.As the latency period between exposure to dieldrin and the development of malignancy is thought to be from fifteen to thirty years, the next few years are likely to provide an answer to the question of dieldrin's capacity to induce cancer in humans. As with the polyvinyl chlorides, the first victims of which are now developing cancers of the liver, dieldrin's pervasiveness has made the entire population the test group for resolution of the issue. It is now virtually impossible to conduct controlled experiments of the effects of dieldrin, owing to the unavailability of a dieldrin-free control group.

In late March, just after EPA finished presenting its case against aldrin/dieldrin before Judge Perlman, the destruction of millions of dieldrin-contaminated chickens in Mississippi briefly drew national attention to the problem. When Department of Agriculture inspectors found that the chickens contained more than fifteen times the allowable levels of the chemical, the Mississippi Commissioner of Agriculture asked EPA to increase its tolerances so that the birds could be sold and eaten. After brief hesitation, EPA refused, and 7,600,000 birds were gassed and buried. At the time, it was reported that the chickens had eaten feed enriched with vegetable oil that had been contaminated by shipment in a railroad car previously used to transport aldrin. Since then, the Food and Drug Administration, which has authority over animal feeds, has found a more disturbing explanation.

One of the steps in the preparation of raw vegetable oils for human use is "deodorized distillation." While most of the oil is distilled off and recaptured through condensation, a small fraction, known in the trade as "clabber stock," remains. This residue, which contains most of the pesticides and other harmful matter from the raw oil, is also rich in nutrients. If the pesticide level is low enough, clabber stock is valuable as a supplement lfor poultry feeds, but it must otherwise be used for such industrial purposes as lubricating oil drilling bits, for which its monetary value is much less. The difference in price creates an incentive for an unscrupulous businessman to purchase industrial-grade oil from a producer and resell it as a feed supplement to farmers. FDA has already obtained a consent decree against one middleman implicated in the Mississippi case in which he promised to refrain from selling misbranded oil in the future. Further investigations of other individuals are now in progress. There is no indication that the manufacturers of the oil were award of the diversion, or that the chicken producers realized that they were buying mislabeled oil.

In the aftermath of the chicken incident, EPA issued "action level guidelines" limiting the amount of dieldrin tolerable in oils used as feed supplements and in finished feeds. A bill to indemnify chicken producers for their losses passed the Senate but died in the House. According to an aide to Sen. James Eastland, sponsor of the bill, press commentary on medical facilities in the affected areas of Mississippi "made it look as though we cared more about chickens than people."

At the time the contamination of the chickens became known, Shell was preparing to offer rebuttal evidence. On April 5, EPA Assistant Administrator for Enforcement and General Counsel Alan Kirk notified Shell that in light of the evidence developed by its attorneys in the hearings, the Agency was considering whether to order all manufacture and use of aldrin and dieldrin suspended for the duration of the cancellation proceedings. Kirk asked Shell whether it would voluntarily commit itself to halting production pending Judge Perlman's decision on cancellation. Three days later, EPA attorneys filed a motion requesting the judge's consent for the introduction of new evidence, designed to show that adulteration of animal feed with dieldrin-enriched oils was widespread. In addition, they asked permission to recall as a witness Dr. Adrian Gross, a Food and Drug Administration cancer researcher, for further testimony on the cancer risks presented by current dietary levels of dieldrin. The motion stated that EPA would introduce evidence "showing that continued usage of Aldrin and Dieldrin for the next year and a half, resulting in those levels of Dieldrin currently estimated to be present in the average American family's diet, is predicted to cause cancer in as many as 230,000 people in this country."

The EPA attorneys' motion and a second letter from Kirk made clear that the 230,000 figure was a prediction of the eventual effects of present exposure to dieldrin, based on studies of the likelihood that an animal which has ingested the pesticide will develop cancer at any point in its lifetime. Shell counsel William D. Rogers insisted, however, that EPA was blaming dieldrin for some 40 percent of all the cancer reported annually. In a reply to Kirk, dated April 16, Rogers indignantly rejected EPA's request for a voluntary suspension:

There are only 545,000 non-skin cancer cases each year in the entire United States, from all causes … Does the Agency, by adducing [the] new calculations, really mean to suggest that it can halve the non-skin cancer cases in the United States by the simple expedient of banning dieldrin? Does it mean to say that dieldrin is really a more serious cancer threat than cigarettes …? Does it mean to tell the American people that the fight against cancer is so easy and inexpensive? … [A] suspension order at this time would be a legally fruitless gesture which could serve no purpose but to greatly damage and prejudice Shell in terms of both public relations and the pending cancellation proceeding.

On April 12, Rogers wrote to Peter Hutt, Assistant General Counsel of the Department of Health, Education, and Welfare, of which FDA is a part. Rogers informed Hutt that Dr. Gross of the FDA was preparing to testify that dieldrin presently causes 230,000 cases of [4 ELR 10107] cancer yearly. Ten days later, Rogers repeated this assertion in a second letter to Hutt, and stated: "We urge your consideration of this matter because Dr. Gross' testimony cannot help but be taken as a statement from the FDA."

In a lawsuit, the testimony of expert witnesses is usually challenged on cross-examination, rather than by out-of-court contacts with their superiors. Both EPA and EDF protested what they saw as an attempt to intimidate Dr. Gross. On June 11, Judge Perlman stated that to prevent witnesses from feeling "threatened," all future communication with their employers regarding testimony at the hearing should first be directed to the lawyers for the side calling the particular witness.

In the midst of the controversy over his testimony, Dr. Gross prepared a memorandum setting forth his views. He stated that on the basis of overwhelming evidence, including studies by Shell itself, dieldrin is unquestionably carcinogenic, affecting not only the liver, as originally believed, but organs throughout the body.A carcinogen in any mammal is regarded by experts as a potential carcinogen in humans: "A carcinogen is a carcinogen (period)." He could not, however, attempt to estimate the probable incidence of human cancer on the basis of animal research. What EPA's attorneys had done was to note that a certain level of dieldrin intake by animals carried with it a maximum one in one thousand risk of cancer. If it is assumed that all Americans take in an equal amount of dieldrin, that they are all equally susceptible to cancer, and that human and test animals respond similarly to comparably brief exposures to the chemical, then a prediction that another 12 to 18 months use of dieldrin will cause cancer in up to .1 percent of the population could be defended, according to Dr. Gross. While he would not necessarily endorse EPA's extrapolations from his data, he would neither dispute their calculations, provided that the underlying assumptions were understood. Dr. Gross characterized Rogers' representations of his position as a distortion.

Judge Perlman's decision on whether the human health and environmental effects of dieldrin warrant cancellation of the pesticide is not expected until December at the earliest. In September, Shell will begin production of the chemical for the 1975 growing season. By the time any cancellation order is issued, supplies of aldrin/dieldrin will already have been shipped around the country, so that a ban on the use of existing stocks would create a massive disposal problem. If EPA does not issue a suspension order to prevent the manufacture of dieldrin until Judge Perlman rules on the merits of the case, the result may well be another year of the pesticides' use at current levels, even if cancellation is ordered. Since its initial approach to Shell in April, EPA seems to have backed away from attempting to impose an interim suspension. Informed observers agree that the Agency's reluctance is based on deference to Representative Whitten's ability and willingness to slash EPA's budget if it defies him on this issue. One can only hope the medical statistics of twenty and thirty years from now do not show EPA to have been shortsighted when it decided that to err on the side of caution meant appeasing a congressman instead of banning a carcinogen.