FOOD ADDITIVES TUESDAY, SEPTEMBER 19, 1972 U.S. SENATE SELECT COMMITTEE ON NUTRITION AND HUMAN NEEDS Washington, D.C. The Select Committee met at 9:30 a.m., pursuant to call, in room 1318 of the New Senate Office Building, Honorable Gaylord Nelson, presiding. Present: Senators Nelson, Percy, Taft, and Schweiker. Staff members present: Nancy Amidei, acting staff director; Julia C. Bloch and Elizabeth P. Hottell, minority professional staff. OPENING STATEMENT BY SENATOR NELSON, PRESIDING Senator NELSON. The hearings by the Select Committee on Nutrition and Human Needs will come to order. PREPARED STATEMENT OF SENATOR NELSON It is the purpose of these hearings to develop a comprehensive record on the subject of food additives. The American public is becoming as concerned about the quality, safety, and adulteration of the food supply as it is about the quality of the enviornment. According to the Food and Drug Administration, and the food additives industry, Americans consume an average of 5 pounds of additives a year. Some 3,000 additives are approved by the Government for use either directly in food or in packaging materials and other uses that contact food. More than a billion pounds of additives are added to food products and food packaging annually, with sales esitmated by the industry at more than $500 million a year. In these hearings, we will deal with a wide variety of subjects touching on food additives: 1. The process of testing them for safety; 2. The merits of requiring that additives be shown to have a functional necessity in addition to being safe and effective; 3. Whether the Delaney anticancer section of the Food, Drug, and Cosmetic Act should be expanded or changed; 4. Nutritional standard-setting and labeling for foods; 5. The current status of the GRAS (Generally Recognized As Safe) list review; 6. The Government's food additives progam and regulatory activities, including its approval system for additives, and its plans for using the Pine Bluff, Ark., testing center as it relates to food additives. Since introduction of the Food Protection Act (S. 3163) on February 14, 1972, and the Food Additive Safety Act (S. 76) on December 22, 1969, a number of events have occurred that demonstrate the need for attention to food additives. New scientific evidence has forced reconsideration of the safety of additives, including nitrites and nitrates in processed meats; Violet No. 1 and Red No. 2 dyes; saccharin; sodium acid pyrophospate (SAPP), newly approved for use in meat products; and DES (diethylstilbestrol), the hormone used as an animal feed fattener. The list grows daily of additives that are under new scientific scrutiny and have questionable value or safety levels. The purpose of these hearings is to determine what is being done to protect the public health in the area of food additives; whether new steps are necessary; and, basically, whether a new philosophy is in order, concerning the necessity and nutritional value of the thousands of chemicals added to the nation's food supply. The White House Conference on Food, Nutrition and Health in 1970 addressed many of these issues. The Food Protection Act (S. 3163) and the Food Additive Safety Act (S. 76)— which will be discussed in these hearings-are based on the recommendations of that Conference. A statement on S. 3163, and a copy of the bill, along with a copy of S. 76, will be inserted for the record, following these remarks, along with several supportive papers and articles. We regret that Congressman James Delaney was not able to testify. He was to be the lead-off witness. We regret that Congressman James Delaney will not be able to testify. His wife passed away last Friday. He was to lead off the hearings. Congressman Delaney has pioneered the food additives field since 1950, when he conducted hearings before the House Select Committee on Chemicals in Foods, Drugs and Cosmetics. He is the author of the Delaney anticancer section of the Food, Drug and Cosmetic Act. His hearings directly or indirectly led to passage of the 1954 Pesticide Amendments, the 1958 Food Additives Amendment, and the 1960 Color Additive Amendment, all to the Food, Drug and Cosmetic Act. The committee also will take pertinent testimony for the record from others who are not appearing in person. Senator NELSON. We will also submit for the record the prepared statement of Senator McGovern, chairman of this committee, who is unable to be with us this morning. PREPARED STATEMENT OF SENATOR MCGOVERN, CHAIRMAN A little more than 3 years ago, in July 1969, this committee conducted hearings into the safety and quality of the food supply. Spokesmen for industry, consumer advocates, and research scientists commented on a wide range of concerns about the food supply. At that time attention was focused on the Generally Recognized As Safe (GRAS) list of food chemicals, certain questionable ingredients in baby foods, and the efforts of the food industry to insure the quality and safety of all of their products. In the months that followed these hearings a number of dramatic events underlined the importance of the questions these hearings had raised. The Secretary of Health, Education, and Welfare removed cyclamate, the artificial sweetener, from the GRAS list. Baby food companies, in a show of corporate statesmanship, agreed to remove monosodium glutamate from baby food and to reduce the level of salt in their products. The President ordered an immediate and thorough review of the GRAS list. Each of these events touch directly on the food safety bills which are the subject of these hearings and which were introduced by one member of this committee, Senator Gaylord Nelson (D-Wisc.). There is now clearly national interest among concerned food producers as well as consumer groups-in the problem of food quality and safety. Efforts on the part of businessmen, the Food and Drug Administration, and consumer advocates are already underway to improve the system of food regulation. The hearings today and tomorrow are intended to develop a comprehensive record of the issues related to food safety regulation. It is my hope, that all individuals concerned with this problem, from whatever perspective, will make their opinion of these food bills known. The final product should be a workable system of food regulation, which is fair to the food industry while protecting the food consumer. The advances in scientific knowledge and regulatory technique that have taken place over the last decade and a half make a review of the food protection laws a current necessity. A 78-page report on the widespread use in human food of sodium nitrite, a substance that combines with other substances in the diet to produce known carcinogens (cancer-causing agents), was submitted today to Senator Gaylord Nelson's Select Committee on Nutrition and Human Needs by the Environmental Defense Fund. The committee is holding hearings on food safety and regulation. The report, written by Dale Hattis, a graduate student in genetics at the Stanford University Medical School, charges that the Food and Drug Administration (FDA) has consistently refused to comply with its plain legal mandate to protect the public against fish products adulterated with sodium nitrite, even though the FDA, as early as 1948, took the position, in a document entitled "Administration Information Letter No. 12" (Sept. 20, 1948), that: Sodium nitrite is: poisonous and deleterious . . . [and] not required in the manufacture of any food subject to the jurisdiction of the Food, Drug and Cosmetic Act.... This "Administration Information Letter" stated that: any food subject to the act and containing any quantity of [sodium nitrite] would be adulterated under the law, regardless of labelling. Sodium nitrite has been shown to combine with other substances in the stomach to form chemicals which are powerfully carcinogenic in a wide variety of animal species, including monkeys. The Hattis report says that "it is highly unlikely that man will prove to be the only species resistant to their action." The report charges that with full knowledge of the dangers, the FDA has permitted the widespread use of sodium nitrite in fish products, in one case specifically because an industry spokesman told the agency that the substance retarded spoilage "when the FDA recommended processing time and temperature are not followed." Thus, the report says, the FDA allowed the use of this substance as a substitute for "enforcing reasonable sanitation" in the fish processing industry. Last spring, the Environmental Defense Fund brought suit against the FDA, under the Freedom of Information Act, to compel disclosure of FDA files relating to sodium nitrite, which the agency had theretofore refused to make public. After the suit was filed, the FDA changed its position and made these materials available. These internal FDA documents, the report says, show that the FDA has repeatedly backed down, in the face of industry pressure, from its original positions on sanitary manufacturing processes for fish products, and instead maintains a "current policy of deferring action in favor of endless study" of the cancer-. producing properties of sodium nitrite in human beings. In short, the report says, the agency's position is that it "needs conclusive proof [as to ill effects in human beings] before taking any action, that the public should continue to be exposed in the meantime, and that the public [rather than the industry] should bear the cost of the research necessary to supply conducive proof. The law, on the other hand, clearly places the burden of proving safety on industry, and requires that the public not be exposed until all reasonable doubts about safety have been resolved." The Environmental Defense Fund is a nationwide coalition of lawyers, scientists and other concerned citizens devoted to protecting the human environment. It has more than 30,000 members from coast to coast, with offices in Washington, D.C., Berkeley, Calif., and East Setauket, N. Y. Senator NELSON. Our first witness this morning is the Honorable Congressman Clarence J. Brown of Ohio. Your statement will be printed in full in the record or you may present it, however you desire. STATEMENT OF HON. CLARENCE J. BROWN, A REPRESENTATIVE IN CONGRESS OF THE UNITED STATES FROM THE SEVENTH DISTRICT OF THE STATE OF OHIO Mr. BROWN. Thank you, Mr. Chairman. Mr. Chairman, I appreciate the opportunity to appear before you this morning to testify on the issue of food additives, an area very appropriately being considered by the Select Committee on Nutrition. and Human Needs. As one who in recent years has developed a growing interest in the benefits and problems associated with food additives, I congratulate you on the comprehensive study your committee is undertaking. IN-DEPTH CONGRESSIONAL STUDY WARRANTED Certainly the impact of food additives, both economically and more fundamentally in terms of human health is so significant as to justify an in-depth congressional study. My own concern stems from the years I have spent on the Fountain subcommittee in the House, the Intergovernmental Relations Subcommittee of the Government Operations Committee, where a great deal of our time has been devoted to oversight of the Food and Drug Administration. During this period the food additives issue has surfaced time and time again as the subject of our considerations. Most recently, we issued a report on the use of nitrites and nitrates as meat preservatives and held a hearing in which Senator Kennedy of this subcommittee testified concerning a recent FDA ban and phaseout of DES in animal feed. PROBLEM HANDLED INCORRECTLY The result, for me, of these and other experiences has been the development of a conviction that we are not handling the food additive problem correctly. The growing conflict between the laws currently on the books and the developing expertise of modern science has produced a situation where, to use a tired phrase, the tail is wagging the dog. I would hope that out of these hearings some new approach might be found which will obviate the problem we are currently going through with an increasing number of food and feed additives. Unless we do, I fear we will soon face a crisis of confidence among the American people each night as they sit down to dinner. My friend and colleague, Congressman Delaney, during the late 1950's, guided through Congress the important amendment to the Food, Drug, and Cosmetic Act now bears his name. At the time of its enactment and for a number of years since, the Delaney clause provided an adequate response to our legitimate concern about carcinogenic substances in food additives. The zero tolerance level which the clause demands was appropriate for the state of scientific art at the time. The last several years, however, have seen dramatic increases in the sophistication of scientific techniques. FOOD ADDITIVES PROMOTE CANCER We can now detect the presence of chemical substances at levels down to one or two parts per million, an amount almost inconceivably small. At the same time, improved test methods have found that a growing number of traditional and economically important food additives, if administered to animals in massive doses, are cancer producing or promoting in those animals. The result of these current developments has been an increasingly important role for the Delaney clause. Therein lies the problem. We all want to assure that the food people eat will not harm them, and insofar as it is possible, Government should assure this. But it must be recognized that absolute guaranties may not always be possible, even for something as big, pervasive, and powerful as the Federal Government. In an area where surprisingly so little scientifically is provable, the safety of something as basic as food must be related to its availability and cost, and less important factors such as taste and attractiveness. No government could survive if it were to assure a totally safe food supply, one that is so reduced in quality as to bring the nation to starvation. To ignore safety in our food supply today would not be politically acceptable, nor, more importantly, in the public interest. It is obvious, then, that some tradeoff relating to the safety of our food supply under certain circumstances may prove to be necessary. Such tradeoffs are already being made under the laws guiding governmental approval or disapproval of medicines and drugs. Some drugs are now totally prohibited because they have no benefits or because their benefits are far offset by their substantial harms. But some drugs which may be harmful in general have such benefits in certain diseases that they are permitted under certain limited or controlled circumstances. MANY HARMFUL DRUGS NOT RESTRICTED Many other drugs may have more general benefits but still be harmful if improperly used. The general use of such drugs is not prescribed except for warning labels, of course; some drugs are not restricted at all. The Delaney clause does not permit such governmental judgment. It absolutely prohibits the use of any food additive which is carcinogenic in man or animal, and removes any possibility of administrative choice. Unfortunately, this prohibition applies in an area which is scientifically hazy. The massive dose of a substance given to a laboratory animal which then develops cancer may or may not prove that a massive or minimum dose of the same substance would induce cancer in humans, but the Delaney clause makes no such distinctions. As a matter of fact, the Delaney clause does not provide the latitude with reference to additives in the food supply which our laws permit in the case of medicinal drugs, and a crisis may be brewing as a result for those in our Nation afflicted with a specific disease, diabetes. An increasing number of prohibitions of artificial food sweeteners will gradually reduce the options of those who suffer from diabetes. In their case, the Delaney clause does not allow for the medicinal advantages of a food additive. The clause does not speak to what happens to food additives which are safe in and of themselves after they are in the food supply and interact chemically with other substances during cooking or in the process of ingestion or digestion. Presumably, court interpretations of the clause might provide answers in these hazy areas, but shouldn't the Congress address itself to these issues first? ALL OR NOTHING PHILOSOPHY OF DELANEY CLAUSE The good intent behind the Delaney clause cannot be questioned, nor is it at issue. The question that is attracting increasing attention, |