Bionetics Laboratories under contract on the tumorigenic activity of approximately 100 pesticides. Although this report admittedly reflected a screening study, it raised serious questions about the safety of several widely used pesticides. Moreover, a report on the mutagenic and teratogenic activity of the same pesticides was pending and was later made available to the Secretary's Commission. The event that actually precipitated the appointment of the Commission was the FDA seizure beginning in March 1969 of shipments of coho salmon from Lake Michigan containing total total DDT residues (DDT + DDE + DDD) ranging upward to 19 parts per million. This was an alarming development not only to the fishing industry but also to public health and agricultural officials and to the Governors of the States adjoining Lake Michigan. How had Lake Michigan been contaminated by DDT and what about the future of its fishing industry? What corrective action was in order? In a statement issued April 21, 1969, Secretary Finch said: "The health of our citizens is properly the first concern of this Department. As Secretary of HEW, I have become increasingly concerned by the evidence of pesticides that persist in the environment. "I think it is time to question the continued use of persistent pesticides in our environment, to move forward to the use of more degradable chemicals and to stimulate research and production in the field of biological controls. "To do this we must first examine the extent of the use of pesticides in the United States, their relative degradability and persistence, and the adequacy of our knowledge of their chronic and acute effects upon human health. This must be done in an atmosphere of scientific detachment, removed from the emotionalism that is naturally present when we discuss man and his environment. "I wish at this time to announce the appointment of a Secretary's Commission on Pesticides and Their Relationship to Environmental Health to explore the field of environmental pollution and its consequent risks to the health of our citizens. The Commission is to report back with specific suggestions for action in six months." I n his statement, the Secretary noted that as long ago as 1963 the President's Science Advisory Committee had recommended the elimination of persistent toxic pesticides as the goal and that six years later we were still too far from that goal. On the following day, April 22, FDA established an interim guideline level of 5 parts per million DDT in fish shipped in interstate commerce. The Commissioner of Food and Drugs explained that this guideline was intended to protect the public from excessive levels of DDT in fish until a full scientific review was completed. It was then with some feeling of urgency that the Commission began work immediately, holding its first full meeting on June 26-27, 1969. Most of the 14 Commission members were from the academic world, but industry was represented by Dr. Julius Johnson of the Dow Chemical Company and Dr. Edwin F. Alder of Eli Lilly and Company. The U.S. consumer was represented by Virginia Knauer, the White House Assistant for Consumer Affairs. Dr. William J. Darby of Vanderbilt University was named Cochairman. Necessary funds and manpower were placed at the disposal of the Commission. Secretary Finch provided ample clerical support and a full backup team of 12 experts from the Department headed by Dr. Albert C. Kolbye of the Consumer Protection and Environmental Health Service, who served as Executive Secretary and Staff Director. Dr. Dale R. Lindsay, later to become Associate Commissioner for Science of the Food and Drug Administration, was named as a Special Assistant to the Commission. To develop a solid comprehensive base upon which to rest its recommendations, the Commission studied the following aspects of the pesticide problem by organizing into five subcommittees: (1) Uses and Benefits of Pesticides; (2) Contamination; (3) Effects of Pesticides on Non-Target Organisms Other Than Man; (4) Effects of Pesticides on Man; and (5) Criteria and Recommendations. Later the Commission established advisory panels of experts to appraise these specialized areas: (1) Carcinogenesis, (2) Interactions, (3) Mutagenesis, and (4) Teratogenesis. The reviews of the subcommittees and the advisory panels were made in the light of a vast amount of new scientific data and other information developed in the past several years. Discussions were held with pesticide experts from the Department of Agriculture and the Department of Interior as well as DHEW, and with experts from the universities, the industry, and other research institutions. With respect to public policy the Commission also reviewed the reports and the recommendations of the advisory bodies mentioned earlier, since they were also directed toward a sound national policy on pesticides. During the course of the Commission's study, a National Research Council Committee on Persistent Pesticides, under contract with USDA, made its report in May 1969. This report's first recommendation—that further and more effective steps be taken to reduce the needless or inadvertent release of persistent pesticides into the environment-provides additional support for the Commission's own recommendations. In transmitting the Commission's report to the Secretary, the Chairman, Dr. Emil Mrak, wrote: "These recommendations are arranged in an action priority order as seen by the Commission; however, this order has no significance as to their relative importance. In my own view the recommendations support the following principles: "1. Chemicals, including pesti cides used to increase food production, are of such importance in modern life that we must learn to live with them; "2. In looking at their relative merits and hazards we must make individual judgments upon the value of each chemical, including the alternatives presented by the nonuse of these chemicals. We must continue to accumulate scientific data about the effects of these chemicals on the total ecology; and "3. The final decision regarding the usage of these chemicals must be made by those governmental agencies with the statutory responsibilities for the public health, and for pesticide registration." T he 14 recommendations of the Commission reflect a comprehensive study in depth as well as breadth by a "blue-ribbon" group that is expected to have a tremendous impact upon pesticide usage in the United States and possibly the world. The Commission's recommendations: I. Initiate closer cooperation among the Departments of HEW, Agriculture, and Interior on pesticide problems through establishment of a new interagency agreement. II. Improve cooperation among the various elements of DHEW which are concerned with the effects of pest control and pesticides. III. Eliminate within two years all uses of DDT and DDD in the United States, excepting those uses essential to the preservation of human health and welfare and approved unanimously by the Secretaries of the Departments of HEW, Agriculture, and Interior. IV. Restrict the usage of certain persistent pesticides in the United States to specific essential uses which create no known hazard to human health or to the quality of the environment and which are unanimously approved by the Secretaries of the Departments of HEW, Agriculture, and Interior. V. Minimize human exposure to those pesticides considered to pre sent a potential health hazard to man. VI. Create a Pesticide Advisory Committee in DHEW to evaluate information on the hazards of pesticides to human health and environmental quality and to advise the Secretary on related matters. VII. Develop suitable standards for pesticide content of food, water, and air and other aspects of environmental quality that (1) protect the public from undue hazards, and (2) recognize the need for optimal human nutrition and food supply. VIII. Seek modification of the Delaney Clause to permit the Secretary of DHEW to determine when evidence of carcinogenesis justifies containing analytically restrictive action concerning food detectable traces of chemicals. IX. Establish a DHEW clearinghouse for pesticide information and develop pesticide protection teams. X. Increase Federal support of research on all methods of pest control, the effects of pesticides on human health and on the ecosystems, and on improved techniques for prediction of human effects. XI. Provide incentives to industry to encourage the development of more specific pest control chemicals. XII. Review and consider the adequacy of legislation and regulation designed to: 1. Improve the effectiveness of labeling and instructions to users 2. Extend the present concept of experimental permits as a mechanism to register pesticides initially on a restricted basis to enable close ob servation, documentation, and reassessment of direct and indirect effects under conditions of practical usage. 3. Improve packaging and transportation practices in order to minimize dangers of spillage and the contamination of vehicles and of other merchandise. 4. Provide for monitoring and control of effluents from plants manufacturing, formulating, and using pesticides. 5. Provide uniform indemnification to parties injured by mistakes in pesticide regulatory actions by Federal and State authorities. XIII. Develop, in consultation with the Council of State Governments, model regulations for the collection and disposal of unused pesticides, used containers, and other pesticide contaminated materials. XIV. Increase participation in international cooperative efforts to promote safe and effective usage of pesticides. The complete, detailed reports of the subcommittees and of the expert advisory panels, which support the recommendations, were published as Part II of the report. The complete Report of the Secretary's Commission on Pesticides and Their Relationship to Environmental Health is available for $3 from the Superintendent of Documents, Government Printing Office, Washington, D. C. 20402. In releasing Part I of the Commission's report on November 12, Secretary Finch stated: "The Commission's first recommendation was that a new interagency agreement be written between this Department and the Departments of Agriculture and Interior to tighten control of registration and develop cooperative approaches to the control of health hazards and environmental pollution. As it now stands the legal authority to register pesticides is vested in the Secretary of Agriculture, but we are working toward a new agreement that would preclude the registration of any pesticide on which either the Secretary of HEW or of the Interior is not fully satisfied. I have discussed this matter with Secretary [Clifford M.] Hardin and with Secretary [Walter J.] Hickel and I feel that a cooperative agreement ensuring full consideration and attention to the health and environmental impact of pesticides will be accomplished without asking for new legislation. As a step in this direction, I will refer the Commission's Report to the Environmental Quality Council. I have had discussions on this with Dr. Lee DuBridge, and he assures me it will be on the agenda at the group's next meeting on November 20* "We come now to the specific chemical that stimulated us to call the Commission together initially. The finding of excessive concentrations of DDT in coho salmon caused us to launch this study into the use of pesticides, their effect upon food safety, and the adequacy of our knowledge of their effects upon human health. "While DDT certainly has saved lives in many countries, nevertheless it is the conclusion of the Commission that the use of DDT and DDD be restricted within two years to those uses essential to the preservation of human health or welfare and approved unanimously by the Secretaries of HEW, Agriculture, and Interior. "It should be emphasized, nonetheless, that despite the restrictions we will set on its usage, unavoidable residues of DDT will continue to be found in the ecological chain for a period of years. We will have to set up reasonable methods to make use of our food supply without undue hazard to human health, but in full recognition of the DDT it may already contain." Secretary Finch also indicated that the Delaney clause would not be applied unrealistically against foods bearing small residues of pesticides found to be carcinogenic in certain animals under the conditions of the National Cancer Institute's Bionetics study: "The Department's General Lessel L. Ramsey, Assistant Director for Regulatory Programs in the Bureau of Science since May 1966, joined FDA as a junior chemist in 1942. He is an FDA representative on the staff of 12 DHEW experts assisting the Commission. available. Action will be com- "2. Endorsed the agreement between the Secretaries of Agriculture and HEW providing for HEW to accept responsibility for assessing the public health aspects of all pesticide registrations. Counsel has pointed out that the Delaney Amendment does not apply to pesticide chemical residues in raw agricultural commodities or in foods processed from lawful crops. Nor does it apply to the unavoidable environmental contamination of foods. The unbelievably sophisticated and sensitive measuring devices now in the skilled hands of our laboratory technicians can measure one twentieth part of one unit in a billion. Measurement techniques have improved a thousandfold since the Delaney Amendment was enacted 11 years ago. If the Delaney Amendment, as it is now written, were to be strictly enforced for pesticide residues, it would convert us to a nation of vegetarians. Much of our red meat, many dairy products, some eggs, fowl, and fish-all parts of basic food groups deemed necessary to a balanced diet-ing water. would be outlawed because of very small pesticide residues from the ecological chain." Some of the Commission's recommendations require legislative action by the Congress or the States. Others, however, are being implemented immediately. On November 20 the White House issued a press release that announced the Environmental Quality Council's support for several of the Commission's recommendations. The Council: "1. Applauded the actions taken by Secretary Hardin with regard to DDT registrations: "That immediate notice of can- "That there be a publication of "3. Agreed to continue consultation among the Secretaries of Agriculture, Interior, and HEW on the environmental contamination aspects of pesticide registrations prior to taking action on such registrations. "4. Agreed that HEW should review established tolerance levels of specific pesticides in food and drink "5. Agreed to the establishment of a committee on pesticides of the Environmental Quality Council. This committee would be chaired by the Secretary of Agriculture and include the Secretaries of HEW and Interior and the Executive Secretary of the Environmental Quality Council, and also representation from the Departments of Defense, Transportation, and State, including the Agency for International Development. The committee would establish a working group to provide day-to-day coordination and to develop program and policy proposals for consideration by the committee. This latter group would replace the existing Federal Committee on Pest Control." The notice referred to in item 1 of the foregoing was published in the Federal Register on November 25. It is particularly noteworthy that henceforth the Department of Health, Education, and Welfare will be responsible for making the decision as to whether the public health is adequately protected, not only where food is concerned but with respect to all pesticide uses (item 2 above). Thus, implementation of the key recommendations of the Secretary's Commission is already under way. |