Because we have to reach them also, and it would be desirable to do so.

Can you submit for the record, copies of letters that have gone out from the association, bulletins that have gone out from the association, minutes of meetings, if they are not confidential, where the subject has been discussed, and a program of action been implemented.

In other words, I know we can get action with laws. If you make it a compulsion, you are going to get it done, and every manufacturer would adhere to that standard immediately, whenever the effective date was.

We want to try to hold that off if we can, but I want to be certain that the voluntary effort is going to be effective.

Dr. SOMERS. Senator, can we submit for the record what we anticipate doing, because as I have said, everyone is just now beginning to move forward.

Industry will wait to see what Food and Drug has as a program, and how it is to be implemented, and all our major packers are working feverishly now to develop the basic data which I referred to, which is needed, to see what the variations are.

This has to be done. This is moving forward. It would be premature for me to say that we have already done it.

Senator PERCY. I concur with you in principle. I am trying to be helpful to you. I have seen so many witnesses come down here charged up about doing something, and the minute they walk out that door, and the other problems press in, you ask them a year later, "What have you done?" and they say, "Yes, we are going to get to that."

We intend to follow up on this. We will keep the record open now* for insertion of what has been done to date, and if you care to supplement that by what you intend to do in the future by specifically what dates, we will keep the record open for that, and we will call you back at an appropriate time to see what has been done.

I want to help the association, because I realize you have a gamut of problems you are dealing with.

I want to get this high in priority to see that it is done voluntarily, and I want to help the association, because the companies you represent are fine companies, and they have a lot of things on their minds.

But if you can say this is a high-priority item, then I think we can be assured that we will have action on it.

Dr. SOMERS. I assure you it is high priority. It has occupied a lot of our time in the last couple of years.

QUESTION OF COLOR ADDITIVES

Senator PERCY. I want to be sure I understand the implications of your statement.**

You say that Congress did not wish to relegate the American consumer to a colorless, unappetizing appearing diet when safe additives can be used to provide color and attractiveness to the products.

I concur 100 percent with that policy position. I could not argue with you.

Palatability is a part. After all, I suppose half of our consumption of food is for the necessity of keeping ourselves alive, and maybe better

*See Appendix, p. 1342.

**See prepared statement, p. 1246.

than half is just for the pleasure of the company of eating, and you like to see attractive things, just as certainly many of use through the years have fought against making oleomargarine purple, as some States would have had us do in order to prevent the sale of oleomargarine.

We fought against that as a color subsidy to dairy farmers, and I have a lot of them in my State in northern Illinois. But I could not countenance that kind of approach.

I want to ask you whether or not you include in your statement, additives and coloring that are put on to make it look like something that is not canned.

Oranges, for instance, as I understand it, oranges are colored orange to make them look more like oranges. That doesn't add anything to their taste, because it doesn't change the taste. It doesn't change the color inside at all. As I understand it, it is just to make them look like they are ripe, when maybe they are not ripe, or maybe they do come off, maybe they are perfectly good green. But we are all used to eating oranges that are orange, and therefore, they color them orange. That, I am not too concerned about.

But, what if we extend the principle of coloring to-I am not an expert in the field-to say tomatoes, that are green, and people look at them and they want a tomato that looks ripe, and color has been added on the outside to make them look ripe, when essentially they are not ripe yet.

You essentially would not support that kind of what would be considered deception?

Dr. SOMERS. We have not supported that.

On the oranges, it is a cosmetic factor. They are ripe as far as eating quality is concerned.

As far as appearance, they don't appear to be ripe. It is done for cosmetic reasons.

Senator PERCY. How about color additives for meat products? We like our meats nice and red, and so forth.

Is it possible, do you know, to take commercial grade or lower meat, and make it look more palatable, then pass it off as higher quality. higher grade meat by color additives?

Dr. SOMERS. I am not competent to comment on that, sir.

Senator PERCY. In other words, from the standpoint of principle, you would support additives that add something to the customer's enjoyment, but would oppose, and the industry would oppose, anything that would be receptive to the customer, leading him to believe that he is getting something he is not getting, because he has been fooled and trained to judge something by color?

Would you oppose that?

Dr. SOMERS. We would oppose that; yes.

Senator PERCY. Then we have no difference of opinion on that at all. Just a few general questions, and I think we are finished.

USE OF FOOD CHEMICALS BY CANNERS

Do canners use essentially a large number of food chemicals?
Dr. SOMERS. Well-

Senator PERCY. If so, are you able to say how many food chemicals and why they are used?

Dr. SOMERS. I can't say how many. If, included in this you are including pesticides, there are pesticides used, of course.

In the case of some products, chemicals are used for one or another reason, but in total number, I would say they are not as extensively used in canned foods as they are in some other foods.

Maybe that is not a good answer, but that is as much information as I have before me.

Senator PERCY. In your judgment, do you think that companies, canning companies, can get along with somewhat fewer chemicals being added than they now add, which adds cost, and which, while we are making these studies and cumulative studies, and the effect upon the human system, maybe it could be as dangerous as some of the other things that we now have stopped.

In other words, is the industry moving in the direction of continuing to add more additives as we develop all sorts of additives, just like the drug field?

We have a drug, for almost anything. If you want to feel this way, you can take a drug for it. I am more worried about that than food. They are very minor compared to that.

But, is there a tendency in the industry to keep adding more and more chemicals, or do you see a possibility to taper off a little bit until we know what the effect of the chemicals will be?

Dr. SOMERS. I would say no chemical can be used which is not checked out as to safety.

Certainly, under today's atmosphere, any food manufacturer would be foolish to use a chemical on which there was any question.

There are certain chemicals that are used for specific purposes. They prevent other reactions which are undesirable. For example, in seafood products, chemicals are added to stop the formation of crystals which can be mistaken for glass by the consumer.

In development of new products, we run into problems of stability, which can be corrected by stabilizers, but as far as I know, there is no tendency to go wild in the use of additives beyond where it is either a processing requirement or necessary for manufacturing products.

INCREASE IN FOOD ADDITIVES BUSINESS EXPECTED

Senator PERCY. According to reports made by the American Chemical Society last year, the food additives business is expected to boom from $500 million in sales now to an estimated $756 million by 1980.

So that in a relatively few years, the additive business is going up faster than our population increase, or the increase which I presume is 2 to 3 percent for the canning industry and so forth.

It would appear to me that the use of chemicals by the canning industry is likely to increase substantially, if that is what they expect to sell.

Is this true? And are you at all concerned about it?

Dr. SOMERS. You don't know that it is true.

Yes; we are concerned about it, and we think it is appropriate that groups such as-a body such as this committee-would be concerned about additives. We know the Food and Drug Administration is very much concerned about additives.

76-300-73-pt. 4B

Certainly their review of additives, or substances on the GRAS list is justified, and in no way, to my knowledge, has the canning industry tried to thwart any efforts to get facts about additives.

Senator PERCY. Is the industry willing to take a position that whenever a food product is canned, that all chemicals that are added to it by the canner should be listed on the label?

Dr. SOMERS. We took such a position over a year ago.
Senator PERCY. Is that in effect now?

Dr. SOMERS. We are voluntarily moving in this direction.

I can't say every canned product has it accomplished, but as labels are being changed, it is being done.

Senator PERCY. Lastly, do you happen to know if any of the companies you represent, plan to invest in the so-called organic food market in the light of its growing popularity with the public?

Dr. SOMERS. I don't have any knowledge on this. I suspect there may be some, but I don't have any facts.

Senator PERCY. Is it possible the industry could provide figures to us?

I don't know where else to go-maybe commerce-as to what is happening in the organic food industry, what the percentage of food thus marketed is today?

If you can get that information, I would like to have it to complete our record.

Dr. SOMERS. I expect the chain stores would have more information, because that is where those foods are sold.

Senator PERCY. I want to thank you for your testimony today, which has been both interesting and helpful.

Our next and last witness is Dr. Samuel Epstein.

STATEMENT OF DR. SAMUEL EPSTEIN, CASE-WESTERN RESERVE UNIVERSITY MEDICAL SCHOOL, CLEVELAND, OHIO

Dr. EPSTEIN. The subject of my presentation today is "The Delaney Amendment, and the Mechanisms for Reducing Constraints in the Regulatory Process, in General, and as It Is Applied to Food Additives, in Particular."

My professional background and experience, as stated in the attached appendix to my prepared statement,* in general, relate to the study of biological hazards due to chemical pollutants in the human environment. I am additionally concerned in the role of the scientist and citizen in decisionmaking processess.

It has now become axiomatic that there are major defects in decisionmaking procedures in regulatory processes, in general, and in the regulatory activities of the FDA relating to food additives, in particular. Senator PERCY. Dr. Epstein, I have just gotten a copy of your testimony. Was it available to us for reading last night?

Dr. EPSTEIN. Yes.

Senator PERCY. I am sorry. I didn't get it. Your testimony is 50 pages long. If you would like to summarize it, that would be better, because I have a luncheon, and our chairman is trying to come back

*See prepared statement, p. 1299.

as quickly as he can. I think it might help all of us if you could summarize it.

Dr. EPSTEIN. It is my intention to do just that, Senator.
Senator PERCY. Thank you very much indeed.

CITIZEN AND CONSUMER HAVE NO PART IN DECISIONS

Dr. EPSTEIN. It is my contention that the system of checks and balances essential to the democratic process is largely absent from FDA regulatory practice. Apart from limited post hoc recourse, the citizen and consumer, and those who represent his interests, scientifically, and legally, are virtually excluded from involvement in decisions vitally affecting them. The concept of matching benefit against risk has been often applied by the FDA to maximize short-term benefits to industry, even though this may entail minimal benefits and maximal risks to the consumer.

While such an approach is of course detrimental to the consumer, it is also detrimental to the long-term interests of industry, which may and does suffer major economic dislocation when hazardous products, to which it has improperly developed major commitments, are belatedly banned from commerce. Such problems are, in large measure, attributable to crippling constraints which have developed and which now dominate the decisionmaking process within the FDA.

Responsibility for these constraints in the FDA must be shared by the legislature, by the scientific community, and by consumers and citizens, who have not yet developed adequate mechanisms for protecting their own vital rights and interests.

I propose to summarize my remarks under five headings. The first will relate to the Delaney amendment, and I propose to rebut the criticisms of it made by the FDA this morning.

The second is the justification for the extension of the Delaney amendment to both teratogens and mutagens.

The third is the regulatory process. It will be my contention that in this country you can buy the data you require to support your case. This is a most serious charge, which I propose to detail and support. My fourth set of comments will relate to the Pine Bluffs facility. My final comments deal with Senate bills S. 76 and S. 3163.

First, the philosophical and scientific basis for the Delaney amendment largely derives from a meeting of the International Union Against Cancer in 1954. At this meeting, sharp distinctions were made between reversible and irreversible effects of chemicals. For chemicals inducing reversible toxic effects, it was agreed that threshold levels, below which human exposure would be safe, could be reasonably determined; however, for chemicals inducing irreversible and possibly cumulative effects, such as carcinogens, such threshold levels could in no way be defined.

This fundamental distinction was further emphasized at a symposium of the International Union Against Cancer 2 years later, all participants of which unanimously recommended that: "As a basis for active cancer prevention, the proper authorities of various countries promulgate and enact adequate rules and regulations prohibiting the addition to food of any substances having potential carcinogenicity."