Opinion ID: 305182
Heading Depth: 1
Heading Rank: 4

Heading: epa's reasons for declining to order immediate

Text: 24 SUSPENSION OF ALDRIN AND DIELDRIN REGISTRATIONS 25 1. The Decisions Taken By The EPA Administrator 26 The EPA initiated an administrative investigation into registrations for aldrin and dieldrin that resulted in cancellation of registrations for certain uses. On December 2, 1970, the EDF addressed a petition to the Administrator requesting the suspension and eventual cancellation of registrations for all products containing aldrin and dieldrin. In order to expedite the administrative process, and in light of our January 1971 decisions in EDF v. Ruckelshaus and Wellford v. Ruckelshaus, relating to DDT, and 2, 4, 5-T, the Administrator consolidated the consideration of registrations of DDT; 2, 4, 5-T; aldrin and dieldrin. On March 18, 1971, he issued his Statement of Reasons Underlying the Registrations Decisions concerning these products, the decision to issue notices of cancellation for all registrations for those substances, and also the decision not to order interim suspension of registrations pending administrative decision. 27 EPA's decision to issue notices of cancellation merely sets in motion the administrative process and is not a reviewable order, EDF v. Ruckelshaus, 439 F.2d at 592. As to EDF's petition for suspension of registrations, the Administrator accepted the alternative contemplated in EDF v. Ruckelshaus, to develop suspension criteria case-by-case, pointing out that the magnitude of the variables intrinsic in particular decisions made binding general regulations impractical, Statement, p. 7. But in recognition of the desirability of giving general guidance, the Administrator articulated a framework of certain general factual and policy variables. 28 2. General Approach of EPA Statement of Reasons 29 This suffices for an introduction to the Statement of Reasons. We now examine it with greater care, and begin with the considerations voiced by the Administrator as defining EPA's general approach. Statutory Tests 30 The EPA's Statement begins with the pertinent Statutory Tests under FIFRA, as presently in force, stating that its thrust is to prohibit- 31 those economic poisons which do not contain directions for use which are necessary and adequate for the protection of the public; 32 those economic poisons which do not contain a warning or caution statement which is adequate to prevent injury to man, vertebrate animals, vegetation and useful invertebrate animals; and 33 those insecticides or herbicides which, when used as directed or in accordance with commonly recognized practice, are injurious to man, vertebrate animals or vegetation (except weeds). 34 The EPA points out that the final decision on registration depends on a balance struck between benefits and dangers to the public health and welfare from the product's use, and comments that the concept of safety of the product is under evolution and refinement in the light of increasing knowledge. 5 Suspension 35 The EPA's Statement points out that whereas a notice of cancellation is appropriate whenever there is a substantial question as to the safety of a product, immediate suspension is authorized only in order to prevent an imminent hazard to the public, and to protect the public by prohibiting shipment of an economic poison so dangerous that its continued use should not be tolerated during the pendency of the administrative process. The EPA described its general criteria for suspension as follows: 36 [T]his Agency will find that an imminent hazard to the public exists when the evidence is sufficient to show that continued registration of an economic poison poses a significant threat of danger to health, or otherwise creates a hazardous situation to the public, that should be corrected immediately to prevent serious injury, and which cannot be permitted to continue during the pendency of administrative proceedings. An imminent hazard may be declared at any point in a chain of events which may ultimately result in harm to the public. It is not necessary that the final anticipated injury actually have occurred prior to a determination that an imminent hazard exists. In this connection, significant injury or potential injury to plants or animals alone could justify a finding of imminent hazard to the public from the use of an economic poison. The type, extent, probability and duration of potential or actual injury to man, plants and animals will be measured in light of the positive benefits accruing from, for example, use of the responsible economic poison in human or animal disease control or food production. General Standards 37 Part II of the Statement of Reasons, captioned Formulation of Standards, begins with the general standards deemed pertinent to the administration of FIFRA. 38 EPA points out that, in general, economic poisons, including those under present consideration, are ecologically crude-that is, by reason of technology limitations, are toxic to non-target organisms as well as to pest life. Thus continued registration for particular ecologically crude pesticides are acceptable only to the extent that the benefits accruing from use of a particular economic poison outweigh the adverse results of effects on nontarget species. EPA cites dramatic steps in disease control and the gradual amelioration of the chronic problem of world hunger as examples of the kind of beneficial effect to be looked for in balancing benefits against harm for specific substances. But it cautions that triumphs of public health achieved in the past will not be permitted to justify future registrations, recognizing that fundamentally different considerations are at work in evaluating use of a dangerous pesticide in a developed country such as the United States rather than in a developing non-industrial nation. 39 The immense difficulties of achieving a comprehensive solution to pesticide control are manifest from the Administrator's Statement of Reasons. It records that there are nearly 45,000 presently outstanding pesticide registrations for hundreds of substances in use over approximately five percent of the total land area of the United States. Available data show wide variety among individual substances both as to effectiveness against target species and as to potential harm to non-target species. Laboratory tests with some substances have raised serious questions regarding carcinogenicity that deserve particular searching because carcinogenic effects are generally cumulative and irreversible when discovered. Threats presented by individual substances vary not only as to observed persistence in the environment but also as to environmental mobility-which in turn depends in part on how a particular pesticide is introduced into the environment, either by ground insertion or by dispersal directly into the ambient air or water. 40 Based on the discussion of these general considerations, the EPA concludes that individual decisions on initial or continued registration must depend on a complex administrative calculus, in which the nature and magnitude of the foreseeable hazards associated with use of a particular product is weighed against the nature of the benefit conferred by its use. 3. Discussion of Aldrin and Dieldrin 41 The EPA's general analysis for suspension, set forth above, is supplemented in the Statement of Reasons by discussions concerning the particular products. Part IV, Dieldrin and Aldrin, comprises slightly more than two pages of the Statement. 42 Dangers Presenting Substantial Questions to Safety 43 We set forth the paragraphs pertinent to the dangers of aldrin and dieldrin considered to present substantial questions as to safety, even though the decision to issue notices of cancellation is not subject to review, because they provide perspective for the questions we must consider. 44 The questions raised concerning the safety of these products are similar to those encountered with DDT in that they result from the persistence of dieldrin (since aldrin residues quickly break down into dieldrin) in the environment and its potential toxicity at low levels. Some studies indicate that dieldrin alone, or in possibly synergistic combination with DDT, has an equivalent potential for adverse effect on non-target predatory wildlife resulting from its low level toxicity intensified by its mobility and concentration up certain food chains. The scientific data also indicate that dieldrin, again like DDT, has an affinity for storage in the fatty tissue of a number of animals, including humans. There are also similar carcinogenic data developed in the laboratory from high dosage rates of dieldrin administered to test animals. 45 Dieldrin and aldrin apparently have a lower threshold of toxicity to warm-blooded animals than does DDT. In fact, instances of non-lethal human poisoning have occurred in those occupationally exposed to heavy concentrations of dieldrin for protracted periods. Recovery following removal from exposure was slow but apparently complete. These potential hazards deserve a full public airing in the administrative forum provided by the cancellation proceeding. Denial of Suspension 46 The Administrator's reasons for denial of suspension, as to aldrin and dieldrin, appear in the following paragraphs of the Statement: 47 [B]ecause the vast majority of the present use of these products is restricted to ground insertion, which presents little foreseeable damage from general environmental mobility, because of the pattern of declining gross use, and because the lower historic introduction of these products into the environmental residue burden to be faced by man and the other biota, the delay inherent in the administrative process does not present an imminent hazard. Thus the substantial question of the safety of these registrations is primarily raised by theoretical data, while review of the evidence from the ambient environment indicates that such potential hazards are not imminent in light of the present registrations. 48 It is significant to note that no residues of either aldrin or dieldrin are now permitted on corn, eggs, milk, poultry, or animal fats shipped in interstate commerce. Because of the use patterns of aldrin and dieldrin, these products constitute the major sources whereby these substances would find their way into human food chains. During the pendency of the administrative process hereby initiated, this Agency will take no action to grant any residue tolerances for these foodstuffs pursuant to the Food, Drug and Cosmetic Act, although initial tolerances have been requested by the manufacturer. 49