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NATIONAL ACADEMY OF SCIENCES,
Washington, D.C., September 28, 1971.

Hon. ABRAHAM RIBICOFF,
U.S. Senate,

Washingtn, D.C.

DEAR SENATOR RIBICOFF: This is in further response to your request for comments on scientific procedures and chemical screening techniques employed by the Food and Drug Administration, the Department of Agriculture and the Environmental Protection Agency in the regulation of chemicals used in man's environment.

As a preface to my comments I should state that the Academy's National Research Council has a number of advisory committees and boards that from time to time have undertaken studies for the government in certain areas of concern to your subcommittee. For your information I have enclosed copies of two recent reports that are relevant to your inquiry. (The Use of Drugs in Animal Feeds. Proceedings of a Symposium NAS/NRC Publication No. 1679, 1969. Evaluating the Safety of Food Chemicals. NAS/NRC, 1970.)

It is important that deliberations on regulatory policies with respect to the uses of chemicals reflect recognition of the role that chemistry must continue to play in supporting the nation's economic growth and social well-being. As our knowledge about chemical substances has expanded there has, of course, been an associated growth in the awareness of hazards associated with their use and application. Unfortunately, the controversy over the effects of chemical usages for human purposes has led to a polarization in attitudes that in turn lessens the objectivity with which we view these problems. Whereas science-based technology provides the mechanisms in modern society for releasing us from the bondage of disease, malnutrition, and poverty, some perceive technology only as a prime cause of many of our social ills. More realistic is the recognition that both benefits and injury may arise from the uses of technology, that constructive application of technology must continue, and that technological change should be accompanied by the purposeful development of appropriate assessment mechanisms to control and reduce potential damage to the environment.

This perspective is important to consideration of the question whether our institutional processes for evaluation and decision making have kept pace with technological and social change. Under any circumstance we must conclude that recently expanded Federal regulatory and monitoring responsibilities make it necessary to expand programs of required research to provide scientific information necessary in supporting the establishment of more effective assessment mechanisms. It is this approach to the problems that have emerged from your hearings on which I would like to address my comments, rather than to any criticisms of alleged agency or bureaucratic misfeasance-an investigative concern that would be inappropirate to the Academy's role and competence.

As for the specific questions your letter raises concerning the adequacy of agency programs, we have responded to a number of these to the extent of our current understanding of their programs, based largely in our previous involvement in thier considerations. These responses are included as an enclosure to this letter. It seems fair to say that replies you have received from the agencies indicate a central concern for human welfare for protecting human beings against the threats of man-made chemicals. Their responses also reflect a constructive understanding of their statutory missions.

However, protection against the threats of man-made chemicals must be defined in finite terms, i.e., certain residual hazards will inevitably remain that society chooses to tolerate. As I indicated in my earlier letter, no caterorical statements can apply in this extremely complex field. The deficiency in our ability to assess these threats is exemplified by the fact that we do not as yet have the capacity to assess adequately the hazard to man from potential chemical carcinogens-or from any of an array of possible low-level insults in man's environment. It would be a disservice to do other than state candidly these uncertainties and limitations.

We do not, for example, know the dose-response curve of known chemical carcinogens at low levels of exposure, let alone know whether a given dose-response pattern is characteristic of a whole range of materials.

Once our limited capacity to evaluate low-level, chronic effects of environmental substances is recognized, the logical approach of responsible agencies seems clear to maintain an aggressive research program that seeks to improve our stance in this regard, and a reasonably flexible effort, using whatever tools are in fact at hand, to handle those instances of suspected risk that surface from time to time.

The present climate of public opinion makes even more complex the task of achieving a balanced program of research and testing. The environment of near hysteria that often surfaces in our consideration of these questions could easily lead us to overreact too rapidly and with insufficient understanding to situations of possible human hazard or environmental deterioration. Witness the current state of the detergent problem. The result, in the long run, could well be detrimental to the health and safety of our people, in that substances necessary to the physical and mental well-being of substantial segments of the population may be removed from the market because they are or are thought to be-in some degree hazardous to a very limited number, as all useful drugs must be. We could also find that national initiative to develop new pharmaceuticals, food additives, or agricultural chemicals may wither as the sheer magnitude of the obstacles to success in such a venture mounts.

It is difficult indeed to escape the conclusion that there must be a concerted effort to steer a conservative course between the two extremes, weighing each case on its merits until such time as we can hope to have the fruits of an effective research program upon which to rely, erring always on the side of safety. This takes a special measure of courage since it is self-evident that some errors will become manifest through hindsight. But this is the only responsible course to steer. Thus while the issues you have identified in your recent hearings are significant aspects of the legislative oversight responsibility, it is important that policy guidelines be developed that will assure the effective utilization of our limited scientific resources in supporting the expanding regulatory functions assigned in recent and pending legislation. The advances made will be an important element for enabling society to receive the benefits of technology at minimum risk.

It is to be expected that some confusion and uncertainty will accompany any major reorganization or expansion of regulatory responsibilities such as those involved in the creation of the Environmental Protection Agency in 1970. The adoption of an ever-widening range of statutory provisions could lead to the need for even further institutional changes to accommodate the enforcement and administration of such laws. For example, it seems clear that our conventional systems of government regulation, based on concepts that found their beginning in certain areas of economic regulation, are not ideally suited to accommodate regulation of activities in the private sector, that are characterized by high technological content-e.g., chemical pesticides, food additives, radiation and drugs. These difficulties are evidenced in the general problem of reconciling the adversary process of administrative regulation with the process of objective scientific fact finding that is essential for providing proper controls over the use of technology. It is further complicated by the increasing demands for broadening the process to permit the participation of all affected interests. The basic dilemma arises from the fact that decisions with respect to the uses of technology must be based upon sound technical information developed by experts; yet these same experts are not necessarily equipped to make judgments on acceptable public risks and benefits, nor are they the sole authorities who should participate in making such judgments. It may well be necessary to devise new institutional concepts to cope with these and similar problems emerging in environmental law.

Related to this concern is the need to provide appropriate institutional flexibility to the executive branch, as well as the resources required to foster a well integrated program of scientific research. As seen in the responses received by you from EPA, USDA and FDA, there is a common requirement for scientific information and for mutual agreement on how that information is to be analyzed and interpreted in making regulatory judgments with respect to the uses of chemicals. An integrated and cooperative approach also will facilitate the optimal employment of the limited supply of toxicological and other technical experts available within the scientific community.

We appreciate this opportunity to assist your Committee and, as I indicated in my earlier letter to you, the Academy would be pleased to make arrangements for further cooperative efforts in your future deliberations on this subject.

Sincerely,

Enclosure.

PHILIP HANDLER, President.

COMMENTS ON AGENCY VIEWS

COMPARATIVE AGENCY TESTING PRACTICES AND TREATMENT OF SCIENTIFIC DATA Our review of the reports to you by FDA and EPA in the area of testing indicates a broad recognition on their part of the carcinogenic, genetical and teratogenic hazards. FDA has a substantially longer history of testing and is particularly sensitive to the inadequacies of present scientific knowledge. Their position recognizes that technical recommendations for some time to come must continue to be based in part upon value judgments. It is extremely difficult to comment on the comparative quality of testing procedures since EPA is still in the process of developing its testing programs. EPA's objective, namely, to test for late effects of pollutants, as well as for acute toxicity, and for mutagenic, teratogenic and oncogenic activity is of course appropriate. However, it will be difficult to evaluate proposed testing practices objectively without a clearer picture of the selection of samples for testing, the techniques used for sampling (environmental material especially), the testing methods selected and the quality of the laboratory work performed. These all are major factors in determining the success or failure of any program. In any event, it must be recognized that it is impossible for any system to be 100 percent effective.

Especially commendable are the efforts to make the Pine Bluff Laboratory available for coordinated use by both agencies through a jointly appointed advisory body, which should make it possible to avoid gross duplications of effort. It seems clear, however, that the use of the Pine Bluff facility is no substitute for a well conceived and thoughtfully planned system of national research facilities manned by competent scientific and professional staff to support the statutory missions that have been established for dealing with chemical uses in our society. On a broader national scale it will require heroic effort on the part of all agencies in their grant and contract work to coordinate efforts and to evolve a truly national and integrated program for testing chemicals and monitoring the environment. Competent toxicologists and clinical pharmacologists are in short supply; every effort should be made to utilize manpower efficiently and to assure that the future supply of competent professionals is more adequate to the demand.

There is a major area of concern to which both the agencies and the Congressional committees must devote their efforts. This is the issue of assigning priorities in the testing programs that are being formulated. While these matters are difficult to answer quickly or even very satisfyingly, the need exists and very specific assignments for developing such priorities should be made. Only after this has been accomplished will it be possible to make judgments on the appropriateness of agency testing programs.

TREATMENT OF THE GENERALLY RECOGNIZED AS SAFE LIST (GRAS)

As you may know the National Research Council is cooperating with the Food and Drug Administration in the development and testing of procedures to be followed in reviewing the safety of "Substances generally recognized as safe" (GRAS). Under this project production and use information on all GRAS substances is being obtained from the food chemical and food processing industries. These data will form the basis of FDA's safety assessment of food additives, as part of their general review of the GRAS substances. Until these data are in hand and summarized for safety evaluation by FDA, it would be unwise to express views on the treatment of the GRAS list. The procedures outlined in the Agency response to your question appear to provide a sound initial basis for testing. We note that the limitation on funds constrains the extent to which the test studies can be initiated and, appropriately, the Agency has indicated its intent to establish a priority basis, based upon greatest consumer exposure.

FDA'S POSITION ON SODIUM NITRATE AND DIETHYLSTILBESTROL
SAFETY

Although the NRC's Agricultural Board has a Committee on Nitrate Accumulation, the latter has generally been concerned with the question of levels of

nitrites and nitrates in soil and water. Thus NRC's involvement in the use of nitrites in food is limited. With respect to the usages of sodium nitrite in foods, the FDA indicated that an Interagency committee has been formed to consider the safety of nitrites and the possible formation of nitrosamines in foods. The question of the safety levels of sodium nitrite usage as a food additive cannot be resolved until this study has been completed. As FDA has stated, the dilemma is clear-as the sodium chloride content of meats is reduced in response to apparent consumer demand, maintenance of sodium nitrite levels becomes more crucial as a protection against the hazards of botulinum. Until consumer tastes change, or a more effective anti-botulinum agent is developed, the inclusion of sodium nitrite seems the lesser hazard.

The Agricultural Board has given only limited attention to the matter of a critical assessment of diethylstilbestrol safety and thus is not prepared to comment upon the aspect of safety. In general, the position taken by FDA with respect to the Department of Agricultural sampling program appears reasonable. USDA'S RESIDUE SURVEILLANCE OF ANTIBIOTICS AND GROWTH HORMONES IN FOOD

ANIMAL FLESH

There are three reports prepared by units of the National Research Council that may be of interest, perhaps only peripherally, to the Subcommittee in its deliberations on this topic:

Hormonal Relationships and Applications in the Production of Meats, Milk, and Eggs. NAS/NRC Publication 714, 1959.

Hormonal Relationships and Applications in the Production of Meats, Milk, and Eggs. Supplement 1966. NAS/NRC Publication No. 1415, 1966.

The Use of Drugs in Animal Feeds. Proceedings of a Symposium. NAS/NRC Publication No. 1679, 1969.

REACTION TO THE POLICIES OF OTHER COUNTRIES IN BANNING THE USE OF HORMONES FROM ANIMAL FEEDS

Your initial question to the Department of Agriculture concerned the use of hormones for animal growth promotion. If such growth promotants are known carcinogens it is quite appropriate that their use be banned. Here the troublesome question concerns the definition of carcinogenic. In one nation a substance might well be defined as carcinogenic if ingested in amounts that could be expected to occur in the normal diet; in another it might be defined in much the terms of the Delaney Amendment-in any amount, by any route, to any species. The matter of hormone usage is largely an economic question, in the sense that efficiency of feed utilization increases, and hence cost of production per pound of carcass decreases.

Whether the banning of hormones in other countries is based on firm data as to their harmful effects, on presumed risk, or on another factor, could be determined only by a detailed study of the particular circumstances in those countries. FDA'S POSITION ON INFORMATION DISCLOSURE AND CONSUMER REPRESENTATION

We have reviewed the response to you from FDA concerning its policy on public access to data, "trade secrets" and toxicological information, as well as information disclosure with respect to the agency's own inhouse data. Their explanation indicates that the regulations and policies that they have instituted are based upon statutory provisions of the law they cite. It is not within our competence to comment constructively upon these legal interpretations. We would note, however, that the experience of the National Academy has quite often been that it is important to maintain the confidentaility of information made available for scientific investigation. The absence of this assurance of confidentiality, particularly in the use of industrial information, would, in the case of such private institutions as the Academy, make it impossible to obtain the information needed in the performance of scientific investigation.

The issue of consumer representation in the formal stages that lead to FDA public advisory bodies, since recourse to the Federal Register establishes a formal process for considering written comments on FDA regulatory decisions prior to their promulgation. In general, the scientific and technical nature of the deliberations of public advisory committees necessitate that their participants be intimately conversant with the scientific issues under advisement. There would appear to be no difficulty in inclusion of appropriately qualified individuals, who

may be affiliated with consumer, occupational or environmental organizations, as members of such advisory bodies. In addition, the committees should feel free to seek the advice, through oral or written presentations, of representative interests who may wish to have their views considered by such advisory bodies. In this way, the committees can assure themselves that the opportunity has been given for the presentation of all viewpoints in their deliberations. It would seem, however, that the views and positions of broadly represented interest groups would have a more effective impact at those institutional levels concerned with policy deliberations rather than in the deliberations of technical advisory bodies. In the latter instance the technical competence of the individual members is the critical factor in the deliberations of the committee rather than their viewpoints as representatives of particular interest groups.

CONCEPT OF "THIRD PARTY TESTING"

Your letter describes a chemical testing referral board that would be authorized to advertise for contract bids from the chemical industry to commercial laboratories. As the letter states, this would become the system to assure that a responsive monitoring mechanism is created for food additives or drugs and would thus eliminate present reliance on the industry's own effort. Without more detailed information on Dr. Epstein's proposal it would be difficult to comment constructively on this proposition.

It seems essential that industry must continue to bear the responsibility for the performance of scientifically sound studies now required under FDA regulation. Dr. Epstein's proposal, unless properly structured, could erode the industry's responsibility for assuring the safety of additives or drugs they propose for registration. Thus it is not clear that such an approach is in the right direction if it weakens the dual but supportive responsibility built into the present system. By this it is meant that the manufacturers now have a responsibility to bear the burden of scientifically establishing the efficacy of drugs and additives. On the other hand, the federal agency has a parallel responsibility for assuring that its regulatory and monitoring activities are based upon scientifically sound studies. These responsibilities are distinct and separate. Whether FDA continues to rely upon its concept of government-industry cooperation or supports a separate independent testing effort, the burden of responsibility upon the industry should not be lessened. Should there be instances in which there arise the need for information on a scale which, for some reason, cannot reasonably be asked of a single industrial organization, it may be that only a large, appropriate Federal laboratory can be expected to undertake such tasks.

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