DEAR MR. RUCKELSHAUS: During the recent hearings on "Chemicals and the Future of Man" before the Senate Subcommittee on Executive Reorganization and Government Research, opening testimony attempted to give first priority to the effects on the general population of chemicals in our food, drugs and environ ment. While five initial witnesses directed most of their comments to the Food and Drug Administration and the Department of Agriculture, it is vividly apparent that no agency can single-handedly cope with problems of this magnitude. Since it is our overall purpose to define with some degree of validity all of the various environmental chemical impacts to which man is exposed, this is an appropriate time to obtain your views on these vital issues. My intention is to provide the Subcommittee with some background information on our total governmental effort to assure that no important line of research is neglected and that no area of regulatory protection is ignored. Basically, I would like to know what regulatory authorities have been vested in EPA for controlling chemical hazard and how your agency intends to achieve prevention and control of environmental threats. Thus, we are especially interested in learning which categories of chemicals over which your agency has jurisdiction and what kinds of testing and surveillance programs you have so far instituted to guard against these potential dangers. In order that the hearing may proceed in constructive fashion, it would be of great value if you could answer the attached questions as soon as convienent. Thank you for your cooperation. Sincerely. ABE RIBICOFF, Chairman. INQUIRIES SUBMITTED TO THE ENVIRONMENTAL PROTECTION AGENCY 1. In environmental health problems, what priorities has EPA established as our most critical challenge? Do you agree that it is the total and cumulative exposure of the individual to these environmental chemicals which is most critical? Do you feel man has been subjected to many more synthetic chemicals in his environment than is reasonable or necessary? Should EPA be permitted to judge whether a chemical, or chemical use, falling within its jurisdiction, is useful-as well as safe-before clearing it on the open market? 2. In a recent speech you gave before the American Society of Toxicology, you stated that EPA scientists believe that a "genuine effort in the study of mutagens... could open up this whole field and produce a vast quantity of essential information in a relatively few years." What exactly are your plans in exploring the mutagenicity-carcinogenicity-teratogenicity complex in terms of chemical exposure and human health? Will EPA undertake active research in this area? If so, will these studies be both short- and long-range? 3. Will EPA research objectives be oriented toward developing new chemical safety protocols? Will EPA attempt to determine the mechanisms by which environmental agents produce deleterious effects in exposed persons? 4. Will EPA support laboratory studies directed to duplicating circumstances of human exposure in experimental models, taking into account such factors of exposure, the way in which chemicals act in combination and the type of human absorbtion? 5. Does EPA intend to study the emergence of environmentally induced disease that is frequently not identified in a cause-and-effect relationship with environmental pollutants? A strong circumstantial case that hepatitis is one of the hidden costs of environmental pollution was reported last summer by the New York Times. Is it within EPA's authority to study such possible environmental-disease links as this? 6. How will EPA collaborate with other elements of our Federal health research? What joint programs will be undertaken in the area of environmental toxicology? 7. Does EPA intend to undertake a study of the social cost of these environmentally-induced debilities? Will you review and analyze chemical agents in terms of cost-benefit to society? 8. Will your agency's research program be geared to investigate and identify opportunities that technology may offer to counteract these threats? 9. What monitoring methods has EPA adopted for pesticides, heavy metals and industrial chemicals. How do you assess the level of danger from these substances today? ENVIRONMENTAL PROTECTION AGENCY, Hon. ABRAHAM RIBICOFF, Committee on Government Operations, Subcommittee on Executive Reorganization and DEAR MR. RIBICOFF: We are pleased to reply to your letter to William D. Ruckelshaus dated April 15 asking about our policies and programs on chemicals in the environment. We have prepared answers to your questions, which are attached. We hope they will be useful to the Senate Subcommittee on Executive Reorganization and Government Research. If we may be of further assistance, please do not hesitate to call on us. Sincerely yours, GRAHAM W. MCGOWAN, ANSWERS TO INQUIRIES SUBMITTED TO EPA 1. In environmental health problems, what priorities has EPA established as our most critical challenge? Do you agree that it is the total and cumulative exposure of the individual to these environmental chemicals which is most critical? Do you feel man has been subjected to many more synthetic chemicals in his environment than is reasonable or necessary? Should EPA be permitted to judge whether a chemical, or chemical use, falling within its jurisdiction, is useful—as well as safe before clearing it on the open market? A. EPA's most critical challenge is to reduce the impact of those pollutants already burdening our population. This poses problems of tremendous mangitude. In order to succeed, we must systematically monitor both exposure to existing substances and human biological reponses to such exposure. However, EPA must so act preventatively against future potential threats. In this regard, a most critical environmental health challenge which EPA faces is to establish a system which will systematically evaluate the safety of new substances before wide scale population exposure. A corrolary of these challenges is that damage to the ecosystem on which man relies must be averted. Therefore, emphasis has been placed on a system of anticipating environmental health problems and a program of health effects intelligence. This activities lead to the promulgation of standards which as a minimum protect the health of the public These standards may also reduce or eliminate other deleterious effects on man's welfare. As control measures are instituted to meet these standards we evaluate the effectiveness of the procedures by our system of health intelligence. We must know the fate of chemicals in the environment. Man has several exposures to the same chemical in air, food, and water; the cumulative and total exposure of the individual to all environmental insults is critical. EPA is concerned about the magnitude of this exposure of new synthetic and heavy metal compounds. In order to effectively deal with these new compounds and others already in the market place, the Administration has proposed admendments to the Hazardous Substances Control Act which would among other things authorize the administrator to restrain the use and distribution of compounds found to be detrimental to man and the environment. 2. In a recent speech you gave before the American Society of Toxicology, you stated that EPA scientists believe that a "genuine effort in the study of mutagens could open up this whole field and produce a vast quantity of essential information in a relatively few years." What exactly are your plans in exploring the mutagenicitycarcinogenicity-teratogenicity complex in terms of chemical exposure and human health? Will EPA undertake active research in this area? If so, will these studies be both short- and long-range? A. EPA is developing a major program to evaluate the potential of environmental chemicals for possible carcinogenic, teratogenic and mutagenic effects. The program calls for active research including both short-term and long-term studies leading towards: (a) Reducing the backlogs of the environmental chemicals to be tested for their carcinogenic, teratogenic and mutagenic potential. (b) Improving the validity of extrapolation from animal to man by developing model species and improving the confidence in dose studies by observing large numbers of animals. (c) Developing more standardized protocols for testing. (d) Testing the effects of simultaneous exposures to environmental chemicals and other stresses. The need for more uniform toxicological tests for carcinogens has been cited in several recent reports (e.g., Secretary's Commission on Pesticides Dec. 1969). These reports have called for standardized protocols with regard to animal species, experimental controls, test levels, administration route, numbers of animals and other pertinent variables. Procedures for teratogenic and mutagenic studies in animals require substantial further development. We will be undertaking much of this work at the National Center for Toxicological Research at Pine Bluff, Arkansas. The Center's policy will be governed by a board composed equally of EPA and FDA members. The National Academy of Science is reviewing protocols that are being developed for use at the Center, as well as test protocols for fuel additives. 3. Will EPA research objectives be oriented toward developing new chemical safety protocols? Will EPA attempt to determine the mechanisms by which environmental agents produce deleterious effects in exposed persons? A. EPA research objectives are currently addressing the problem of providing an accurate assessment of the hazards of environmental chemicals. These approaches include the development of an integrated testing matrix which will (1) identify problem compounds by large scale screening activities in experimental animal studies and human epidemiological surveillance, (2) assess the immediate hazard by determining the environmental and human burden and relating this to dose-response characteristics and (3) estimate the long-term hazards with particular emphasis on carcinogenesis, mutagenesis and teratogenesis through the application of appropriate protocols which will utilize large numbers of animals with chronic low-level exposure via appropriate routes; establishment of standardized epidemiological protocols to study human populations representing exposure gradients (4) provide information on the hazards of the options available if additional regulation is required. B. EPA should, is, and will determine the mechanisms by which environmental agents produce deleterious effects in exposed persons. Such research is necessary to identify delayed adverse responses, particularly those manifested as chronic disease. Often, the human biological response to pollutant exposure is influenced by the presence of other cofactors, such as cigarette smoking, diet, pre-existing disease. These cofactors, acting together, predispose individuals to developing certain chronic diseases. The effects of exposure to environmental pollution may become manifest only after other cofactors are added to an accumulated pollutant burden. To identify these complex reactions, EPA must continue to conduct research on interactions between pollutants and other disease risk factors. This research necessarily delves into mechanisms of action. An additional effort of EPA is the initiation of appropriate interfaces with other Federal agencies, universities and research installations so that their research information can be utilized by EPA. 4. Will EPA support laboratory studies directed to duplicating circumstances of human exposure in experimental models, taking into account such factors of exposure, the way in which chemicals act in combination and the type of human absorption? A. The Bio-Medical Research Branch, with its Clinical Research Section located in Chapel Hill, North Carolina, is now conducting research in human volunteers exposed to selected air pollutants under carefully controlled laboratory conditions. Special concern regarding the influence of carbon monoxide on persons with various forms of heart disease has been expressed by several scientists. Physicians in the Chapel Hill laboratories of EPA are investigating the effects of low doses of carbon monoxide on heart performance before and after exercise in persons of varying ages with and without heart disease. Under a contract with the Institute of Experimental Pathology and Toxicology of Albany Medical College, EPA is supporting research on the effects of long-term, low-level lead exposure in a group of human volunteers. Plans are now in progress to extend this work to several other trace metals. In effect, EPA not only will, but already is, supporting laboratory studies directed to duplicating circumstances of human exposure. Our present facilities, however, are not yet adequate to provide the information we need to model environmental health effects in humans. We are planning to improve our facilities. 5. Does EPA intend to study the emergence of environmentally induced disease that is frequently not identified in a cause-and-effect relationship with environmental pollutants? A strong circumstantial case that hepatitis is one of the hidden costs of environmental pollution was reported last summer by the New York Times. Is it within EPA's authority to study such possible environmental-disease links as this? A. EPA will continue to study environmental links with disease such as infectious hepatitis. There were 48,416 cases of this disease reported in 1969. Infectious hepatitis, like the other enteric diseases, is spread by several routes. Waterborne and shellfish associated outbreaks of hepatitis have been investigated, but person-to-person contact probably accounts for most transmission. Even this route might be amenable to some environmental control, e.g. increase in personal hygiene education. It has been hypothesized that drinikng water is responsible for a significant portion of the endemic spread of hepatitis but this has never been tested. Such a study would be most difficult to conduct at this time because laboratory procedures to isolate the agent are not available. We will be using other viruses as models for this problem until there is some breakthrough in the isolation of the etiologic agent of infectious hepatitis. 6. How will EPA collaborate with other elements of our Federal health research? What joint programs will be undertaken in the area of environmental toxicology? A. EPA has recognized its need to work with all other elements of our total Federal health research effort. Accordingly, we have done much of the initial planning to ensure that effective liasion and cooperation is maintained with the Federal health establishment. Our preception of a joint concern with environmental pollution has led to the following proposed activities, some of which have already been implemented. (a) Identification of health interfaces. (b) Contact with major interface agencies. (c) Meeting with agencies sharing health interfaces. (d) Formal agreements to implement joint or cooperative efforts. (e) Coordination of technical information systems. (f) Exchanges of research staff. (g) Coordination of program planning. (h) Membership on each others' advisory committees. The Federal agencies which have health interfaces with EPA are shown in Figures 1-3 and illustrations of such health research interfaces are presented in Tables 1-5, which are attached. A vigorous program for meeting with Federal agencies having major interfaces is continuing and additional meetings with such agencies are being planned. Illustrative agenda for five such meetings, all with component units of HEW, are also attached. A formal agreement between EPA and DHEW for work to be undertaken at the National Center for Toxicological Research at Pine Bluff, Arkansas, has been negotiated. EPA and DHEW are jointly determining staffing and scientific program content for the Center, which will be administered by FDA. For the current fiscal year, EPA has been allocated in excess of $2 million for supporting |