Dr. SMITH. I hope I have not been merely confusing, Mr. Chairman. Thank you.

Mr. WILLIAMS. The committee will stand adjourned until 10 o'clock tomorrow morning.

(Whereupon, at 12: 10 p. m., the subcommittee adjourned, to reconvene at 10 a. m., Wednesday, July 17, 1957.)

FOOD ADDITIVES

WEDNESDAY, JULY 17, 1957

HOUSE OF REPI ESENTATIVES,

SUBCOMMITTEE ON HEALTH AND SCIENCE OF THE

COMMITTEE ON INTERSTATE AND FOREIGN COMMERCE,

Washington, D.C.

The subcommittee met, pursuant to recess, at 10 a. m., in room 1334 New House Office Building, Hon. John Bell Williams presiding. Mr. WILLIAMS. The committee will please be in order. This morning the Subcommittee on Health and Science continues its hearings on several bills dealing with the subject of food additives. We are pleased to have before the committee this morning Mr. Lawrence A. Coleman, chairman of the chemicals in foods committee of the Manufacturing Chemists' Association, Inc., who will testify from the viewpoint of his organization.

Before I recognize Mr. Coleman for his statement, however, I have a statement to be submitted for the record by Mr. L. S. Hitchner, executive secretary, National Agricultural Chemicals Association, on these several bills.

I submit that for the record.

(The statement referred to is as follows:)

STATEMENT OF L. S. HITCHNER, EXECUTIVE SECRETARY, NATIONAL AGRICULTURAL CHEMICALS ASSOCIATION

The National Agricultural Chemicals Association is a trade association composed of manufacturers and formulators of agricultural pesticides and related chemicals. Its members produce and distribute more than 90 percent of the agricultural pesticides used in the United States.

We appreciate the opportunity of presenting our views on the food additive bills.

Our purpose is to respectfully call the attention of the members of the committee to the fact that the committee previously approved and the Congress enacted, in 1954, legislation regulating agricultural pesticides. A review of the legislative history of that act, Public Law 518 of the 83d Congress, commonly referred to as the Miller pesticide residue amendment, shows beyond doubt that the Congress intended to regulate pesticide chemicals separately and apart from food additives. We believe that this was a sound decision. Pesticide chemicals should not be classified and regulated as foods, as they would be if subject to the bills now before the Committee.

This legislation already enacted assures the public of a safe food supply insofar as the use of agricultural pesticides is concerned. It eliminates the need of any further regulation of these products. This fact is recognized in all the bills now before the committee, in which efforts have been made to provide a specific exemption for pesticide chemicals.

The term "pesticide chemical" as defined in section 201 (q) of the Federal Food, Drug, and Cosmetic Act means any insecticide, fungicide, weed killer, or rodenticide which is used in the production, storage, or transportation of raw 111

agricultural commodities. It is in this sense that we use the term in this statement.

In 1954, the House Interstate and Foreign Commerce Committee after very careful study and consideration favorably reported a bill (H. R. 7125) introduced by Congressman A. L. Miller, to regulate pesticide chemicals in or on raw agricultural commodities. That bill became Public Law 518 of the 83d Congress, and section 408 of the Federal Food, Drug, and Cosmetic Act.

The Miller pesticide residue amendment is quite similar in principle to the bills presently before the committee, and, in fact, may be considered to have been the model for many of them. It requires that products be adequately pretested to establish their safety prior to marketing, and that the proposed use be approved by the Food and Drug Administration and the United States Department of Agriculture. The broad objectives of the bills now before the committee are already achieved as regards pesticide chemicals by this existing section 408 of the Federal Food, Drug, and Cosmetic Act.

The Miller amendment was actively supported by our association and the agricultural chemicals industry even though it placed a heavy additional financial burden on the manufacturers of the products involved. It was also supported by the United States Department of Agriculture, the Department of Health, Education, and Welfare, the land-grant colleges, farm organizations, and consumer groups.

That legislation has been in effect for just 3 years. However, its value to all parties concerned with the production of an adequate, safe, and wholesome food supply has been amply demonstrated and attested to. Since it was enacted, over 1,200 tolerances or exemptions have been set for 82 different pesticide chemicals.

In view of the fact that pesticide chemicals are now adequately regulated, there appears to be no reason to involve them in the proposed legislation now before the committee.

As previously mentioned, all the bills now before the committee contain provisions to exempt pesticide chemicals which are under the Miller pesticide residue amendment. In a few instances, the wording of the exemption is such that there could possibly be in the future some differences of opinion as to its interpretation. To remedy this situation, we will submit shortly a supplemental statement containing suggested amendments to clarify the intent and scope of the exemptions for pesticide chemicals.

We are not acquainted with the technical and legal aspects of the use of chemicals in or on food other than those applied in the production, storage, and transportation of raw agricultural commodities. For this reason, we do not feel qualified to pass comment on the specific previsions of the various bills which would regulate the use of food additives. Accordingly, we have restricted our remarks to the status of pesticide chemicals in relation to the pending legislation.

Your consideration of the foregoing is greatly appreciated.

Mr. WILLIAMS. Mr. Coleman, the committee is pleased to have you before us, and we will be glad to have your statement.

STATEMENT OF LAWRENCE A. COLEMAN, ON BEHALF OF MANUFACTURING CHEMISTS' ASSOCIATION, INC.

Mr. COLEMAN. Thank you, Mr. Chairman.

My name is Lawrence A. Coleman. I appear before this committee as the representative of the Manufacturing Chemists' Association, which is a trade association composed of approximately 160 corporate members which are engaged in the manufacture of products generally referred to as chemicals.

Initially, I should like to say that, on behalf of the association, we wish to thank your committee for the opportunity you are giving us to appear here before you in support of legislation to amend the Federal Food, Drug, and Cosmetic Act.

The Manufacturing Chemists' Association believes that there is need for legislation in the food-additives field. This is a belief which

we have expressed before congressional committees and other public groups over a period of the past several years.

We further believe that there are both good features and unworkable or impracticable features in many of the bills that have been introduced to date on this subject. Weighing the good features of the various bills against the unworkable cr impracticable features, it is the opinion of our association that the bills which have the greatest number of good features, and the least number of features calling for amendment, are the bill introduced by Chairman Harris, H. R. 8390, the companion bill introduced by Representative Wolverton, H. R. 8629, and the bill introduced by Representative O'Hara, H. R. 366. However, before discussing these bills in detail, I should like to review briefly the historical background. As I am sure all of you are aware, the first Federal food legislation in this country was enacted in 1906, its enactment having been brought about by the serious concern expressed in many quarters that the public health was being adversely affected by the careless inclusion of filth in meats, flour, and a wide variety of packaged foods; and the deliberate addition of substances, such as formaldehyde to milk, to mask the effect of its

age.

Thus, the first Food and Drug Act was designed to exclude from foods, materials which had no place in the diet and which could reasonably be expected to be harmful to the consumer.

The act at that time did not touch upon the problem of the deliberate addition to food of additives designed to improve the nutritional value of food, its quality, its esthetic appeal, or to scientifically reduce the perishability of food products.

The 1938 amendments to the Food and Drug Act, among other things, modified the law so as to recognize that, in some instances, in the preparation of food it might be necessary or inevitable to add thereto substances which the act classified broadly as "poisonous" or "deleterious" materials.

The 1938 act granted the Secretary-then the Secretary of Agriculture; now the Secretary of Health, Education, and Welfare-the power to fix tolerable limits for such unavoidable ingredients.

Even with this salutary amendment, and even with this statutory recognition that tolerances could and should be fixed for certain materials which may be harmful in gross quantities, with the advances in techniques of food processing, the act today leaves a great deal to be desired.

There is no provision in the present law, as I have said, even with the 1938 amendments, which covers the situation where a food processor, for a beneficial purpose, adds to a processed food an ingredient not naturally occurring therein.

The absence of provisions in the law covering this matter has been demonstrated over the years to be both inadequate and undesirable from the point of view of not only the Food and Drug Administration, but also from the point of view of those in industry and agriculture whose efforts produce the nation's food supply.

The absence of provisions in the existing law covering the deliberate addition of food additives has left the Food and Drug Administration in the position where they are not readily able to determine precisely what additives are in the food supply and hence are unable

to exercise their directive of insuring full protection of the American health.

The absence of such provisions in the law similarly has left industry in a position where they constantly fear that some unscrupulous person can use food additives which are harmful to the public health, in which the public as well as the careful and reputable processor of foods could suffer from the acts of the unscrupulous few.

Fortunately, the fears of industry as above expressed are not based on actual events. It is to the great credit of both the Food and Drug Administration and the food and chemical industries that, to our knowledge, there have been no incidents of serious food poisoning occasioned by the use of deliberate food additives.

It should also be borne in mind that at the time of the passage of the 1938 amendments, chemistry, and particularly food chemistry, had not yet achieved the great advances that have been made in the past 19 years.

Countless millions of dollars have been spent by the food industry and the chemical industry in finding methods to improve, increase, and better the food supply. Much of this has been done since the passage of the 1938 act.

Modern techniques, modern knowledge, demand a modern law. A modern law, we respectfully submit, is one in which it is made eminently clear that deliberate additives beneficial to the consuming public should be permitted to be used in safe quantities, notwithstanding the fact that it may be demonstrable that some of these beneficial additives could, in gross quantities-that is, quantities bearing no relationship to the amounts actually ingested-cause adverse physiological effects on test animals.

In substance, what this means is that we must divorce from our thinking and from the administration of the food laws the idea that "poisonous" or "deleterious" are absolute concepts; that a food additíve can be denominated a "poison" without reference to the quantity ingested by a human being.

We must, in our thinking, adopt the view that the true test to insure protection of the public health is safety under the conditions of use and that the principal condition of use is the quantity used and that, therefore, the statutory word "poison" is a relative concept.

Before determination of whether a substance can be so classified, one must ask two questions-not only the classical "What is it?"—but secondly, and of equal importance, "How much?"

It is exceedingly gratifying to the chemical industry that all of the bills pending before your committee have adopted this modern scientific approach to the problem of determination of whether or not a particular ingredient may be used in food.

As the spokesman for this association testified last year:

A year ago (1955) we reemphasized our adherence to five basic principles which we believed would command widespread support as the basis for strengthening the Food, Drug, and Cosmetic Act. These may be stated as follows:

1. That every new additive proposed for use in food must be tested by the manufacturer before being publicly used.

2. That the manufacturer's test data and other relevant information must be submitted to the Food and Drug Administration before the additive can bo used.

3. That the manufacturer must bear full responsibility for his own compliance with the law, but that no man should be his own referee as to safety and the adequacy of testing for safety.