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The decision to prohibit the continued use of the cyclamates was based on the Delaney Amendment. The dispatch in which the Secretary acted once having been apprised of the possible carcinogenic consequences emphasizes that in the face of any such a showing considerations of the public health and welfare preclude deferral of action.

Even the regulations promulgated in implementation of the Act emphasize the special responsibility that applies where carcinogenic effects in animals are suspected. In defining the authority of the Secretary to establish zero tolerances where necessary, the regulation cites as an example the situation where "the chemical is carcinogenic to or has other alarming physiological effects upon one or more of the species of the test animal used, when fed in the diet of such animals." (21 CFR 120.6.)

As with regard to the cyclamates, a study conducted under the sponsorship and direction of the Department of Health, Education and Welfare has established the cancerproducing characteristics of DDT. (See Innes, et. al."Bioassay of Pesticides and Industrial Chemicals for Tumorigenicity in Mice: A Preliminary Note", 42 Journal of the National Cancer Institute 1101-1114 (1969).)

But the need to act without delay is even more critical in the case of DDT. First, while the Secretary was able to report, with respect to the cyclamates, "that we have no evidence at this point that cyclamates have indeed caused cancer in humans," the studies of Radomski, et. al. submitted by. petitioners is at least probative circumstantial evidence that

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the same conclusion cannot comfortably be reached with Second, the chemical stability of DDT,

regard to DDT.

with a probable "half-life" of 10 to 15 years, makes it imperative that its usage be prohibited as soon as possible. Lastly, each member of the public, having been warned of the potential danger of the cyclamates, can voluntarily stop the further ingestion of those compounds. But because of the movement of DDT through the ecosystem no element of free choice exists. Like it or not each of us are forced to ingest

DDT residues regularly.

It follows therefore that the Secretary's responsibility to protect the public health and well-being from cancer-producing agents can be realized only by the immediate prohibition of any further application of DDT. We recognize that because of the great mobility, persistence, and solubility characteristics of DDT, it is not possible to achieve a zero tolerance by administrative fiat. But these difficulties, rather than excusing immediate action, make the necessity for such action so much more imperative. At a minimum, the Secretary should establish a zero tolerance for DDT and its residues on all raw agricultural commodities with the possible exemption from seizure of any commodities in which it can be established that any residues are the consequence of applications of DDT that were made prior to the announcement by the Secretary of the zero tolerance.

Accordingly, petitioners respectfully request the immediate establishment of a zero tolerance for DDT on raw

agricultural commodities.

In addition, we request that

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you use your full authority as Secretary of the Department of Health, Education and Welfare to ban the use of DDT and obtain its removal from the market.

[Cite: 160 ANNALS OF THE NEW YORK ACADEMY OF SCIENCES 418 (Proceedings of a conference, "Biological Effects of Pesticides in Mammalian Systems," May 2-5, 1967, New York City, June 23, 1969)]

SUMMARY OF THE CONFERENCE

ON

BIOLOGICAL EFFECTS OF PESTICIDES IN MAMMALIAN SYSTEMS

Michael B. Shimkin

Health Sciences Center

Temple University, Philadelphia, Pa.

Just five years ago a gracious lady, dying of breast cancer, published a book called Silent Spring. Rachel Carson struck a responsive chord among the public, not only about pesticides, but about man's place in his world. Should man, reaching for the stars and holding in his hands the tools of his own complete destruction, strive for total victories, or seek balance with nature through compromises and partial controls?

The book aroused considerable reaction, especially from agricultural and chemical industries and their spokesmen. Miss Carson was not a toxicologist. Undoubtedly, the case was overdrawn, and errors of fact and interpretation could be identified. Nevertheless, her book does belong in that list of provocative publications that touch man's conscience, such as Harriet Beecher Stowe's Uncle Tom's Cabin of 1852, Upton Sinclair's The Jungle of 1906, and, more contemporaneously, Ralph Nader's Unsafe at Any Speed and Morton Mintz's The Thera peutic Nightmare, both of 1965. This meeting, as do many others, represents to a great extent the continued wave of reaction to Rachel Carson's pleas.

It is obvious that modern technology in pesticides, especially Muller's discovery of the antiarthropod activity of DDT, for which he was awarded a Nobel prize in 1948, has provided man with another tremendous power to control his environment. Just as in the case of atomic fission and fusion, this power can be used for purposes to which the human evaluative words of "good" or "evil" are applicable. These attributes are not contained either in atoms or in pesticides; they arise from how man uses them.

World War II, I am told, was the first major war in which casualties caused by military actions exceeded those attributable to disease. DDT was an important, although certainly not the only, reason for this achievement. I know that we became rather contemptuous of typhus fever as we doused whole populations with DDT powder. I also know how much personal comfort was derived from its use in movie houses in San Francisco, which once used to rank among the flea centers of the world.

The obverse side of the coin, even in only the baldest of human terms, is an estimate by the Public Health Service that the average annual death rate in the United States from pesticides in one per million and that nonfatal poisoning is one per 10,000 population. That totals 200 recognized deaths and 20,000 recognized poisonings per year. Although these figures alone define this as a national health problem, the chronic effects on man are yet to be defined. Add to this the many consequences to other species. Add also the fact that this is but one source of continued, mounting contamination of our air, water, food, and every other environmental feature. The problem then acquires the elements for what may well become a catastrophic situation.

Several views, therefore. can be discarded at once as untenable. One is that there is no problem. Two, that things will straighten out if they are ignored, especially by the government. Three, that we really know nothing about the dangers and need a decade of research to determine whether there is a problem.

I

Shimkin: Summary of the Conference

I wish to call your attention to the fact that these are precisely the stated opinions of the representatives of the tobacco industry in regard to the health hazards of tobacco smoking. I might, for once, put in a good word for them: at least smoking is an individual habit, with the primary decision of to smoke or not to smoke made by the individual. With pesticides and other contaminants, however, Texas meat becomes a New Hampshire problem, Ohio river water becomes a Mississippi problem, and New Jersey air is a New York problem, over which the individual exercises no control, and, for that matter, of which he has little knowledge.

When we deal with human affairs, we cannot avoid, although in our culture we do our utmost, the important question of who owns, distributes, and profits from commodities that are simultaneously our pride of progress and the cause of our concerns. The answers to these questions neither deny the value of the products or their contribution nor impugn the honesty of those with vested economic stakes in the process. They do, however, identify those who, in our traditions of law, should be in the role of witnesses rather than in those of jurors.

I am impressed by the thoughtful program that has already been devised on pesticides, some aspects of which have been reported at this conference. My role, I believe, is not limited to extending well-deserved congratulations. It is, rather, to point out possible needs and improvements, as I see them. They should be considered only as suggestions for further deliberation, for I speak only for myself.

My suggestions will be guided by several principles, or, if that sounds too impressive, by several personal viewpoints. The first is that there is no such thing as absolute safety, and determinations that seek this end-point, in toxicity, carcinogenicity, or any other reaction, are not only impracticable, but impossible to attain. The second is that the idea of studying "all" factors, or the "total". environment and its consequences, is neither desirable nor possible. The aim of the scientific method is to find the key reaction, or the specific circumstance, that allows one to understand and, hopefully, to manipulate to our purposes a complex that we encounter. The third viewpoint is that the most important first step in the resolution of any problem is the exactitude with which one poses the question.

Let us start with the third. Obviously, the questions one asks of different pesticides must in themselves be somewhat different. Such differences are further introduced by the circumstances under which the materials are used. All pesticides, I assume, are used in one of three circumstances: (1) in enclosed spaces, by especially trained personnel, (2) by individuals for individual or family purposes, and (3) over wide areas that involve many individuals who may not even be aware of the procedure.

In my opinion, quite different safety considerations are needed in these three situations. I would like to relate them to some resolutions that have been accepted as applicable to drugs. Thus, pesticides to be used only by trained personnel in circumscribed spaces would be equivalent to drugs released only to experts for experimental purposes. This would apply, not only to new agents, but to such old products as hydrocyanic acid, which is still useful for the fumigation of ship holds as long as rigorous control measures are practiced.

For the release of pesticides for individual use, I would think that the same standards as for the sale of drugs over the counter are applicable: tests for safety and for utility. It is a wonder to me that rather specific procedures accepted to demonstrate these features in pharmaceuticals do not seem to apply with equal