Dr. GODDARD. No. They pick up the samples, and the samples are all run centrally here.

Mr. FLOOD. Why do you have laboratories in the regions?

Dr. GODDARD. They do many other tasks. The decision is made as to whether the staff in the district offices can carry out, or cannot carry out certain elements of our program. They may carry out the programs related to chemical testing of substances, pesticides, residues on foods shipped in interstate commerce, the identification of medicines whose origin is open to question. These kind of chemical analyses are carried out in each district.

Mr. RANKIN. May I comment further on page 16 regarding the request that the district send in for medical advice about antibiotics? We certify several thousand lots of antibiotics a year based on analyses conducted in Washington before the products are marketed. It is also necessary, after marketing, to examine these products periodically to be sure that they are not deteriorating with unusual rapidity and therefore becoming unfit for use. The average of 25 requests per year for advice per district would amount to less than 500 inquiries from our field offices about the many stocks that are on the market.

Mr. FLOOD. We have heard that certain types of the early antibiotics are obsolete because the bugs have outflanked them and now eat them for desert and thrive on them.

Are all those so-called obsolete antibiotics on the shelf today? If they are, why would they be there?

Dr. GODDARD. The antibiotics, as they have been developed traditionally, have had a broad utilization against a number of organisms. As time has gone along, the situation has occurred that you have described. Certain organisms have become resistant. To my knowledge, this is not, in any instance, true for all the organisms that that drug was originally effective for. So in the interest of providing

Mr. FLOOD. Even if it is good for one, it is worth while?

Dr. GODDARD. If that is a significant condition, yes. Theoretically, it could be the only drug available for that organism.

MEDICAL REGULATIONS

Mr. FLOOD. To what extent do you get into what you call medical regulations? How do you regulate medicine?

Dr. GODDARD. We do not regulate medicine in the sense of direct regulations on the practice of medicine. We are charged with the responsibility of seeing that the products that are manufactured for use by the public in the instance of over-the-counter preparations, or through purchase on prescription, are both safe and efficacious. Our efforts are aimed at these two aspects of the problem, directly at the industry involved.

VETERINARY FUNCTIONS

Mr. FLOOD. Why is there not an overlapping between your veterinary activities and the Department of Agriculture's Bureau of Animal Husbandry?

How do you get into veterinary work?

Dr. GODDARD. We get into veterinary work because, first of all, we are responsible for seeing that animals as well as humans are protected from serious defects of medication.

Second, because certain items are fed to animals to enhance their growth capability and thus have the potential of affecting humans when these animals are converted to food if there are significant residues, or compounds, remaining in the animal tissue. So it is our responsibility to make certain that the additives which are used in many feeds today

Mr. FLOOD. Is that what you call the microtoxin sort of contamination?

Dr. GODDARD. One could describe this as a microtoxin source, but in other instances it is a rather direct contamination.

Medicines that are given to influence the growth curve of say chickens which had to be discontinued for caponization.

There are 13,000 manufacturers of medicated feeds in the United States, and this industry comes under our cognizance, too. We make inspections of these plants. We check the products being distributed in interstate commerce which are of great significance in the animal husbandry field-cattle and chicken raising.

RADIOACTIVE FALLOUT

Mr. FLOOD. Let me mention this business of radioactive fallout. What is the situation as of this afternoon generally across the board? Where are we better, worse, or are we holding our own as the expression goes?

Dr. GODDARD. The last report I had was we were holding our own. There is some betterment.

Mr. FLOOD. What do you do in a case like that-go to church every Sunday and pray?

Dr. GODDARD. If I thought that would give us the final answer, I would be there every day in the week. The radiological health program of the Public Health Service monitors the radioactivity levels in food, milk, air, and water through an intensive sampling program and a network of sampling stations they have.

When significant problems are encountered, they make us aware, as they also make aware the State health authorities in the affected areas. Mr. RANKIN. We have had also a smaller survey of selected food items that have been identified as a key index to the radioactive contamination.

Mr. FLOOD. Milk, I suppose, is exhibit A.

Mr. RANKIN. Milk is examined by the Public Health Service and State authorities. There are things as leafy vegetables and wheat that are examined. The results of both these surveys indicate that in recent years the radioactive contamination has been dropping.

Mr. FLOOD. Dropping?

Mr. RANKIN. Yes.

Mr. FLOOD. Thank God for that.

Mr. RANKIN. And it is well within levels that have been judged acceptable.

CONVENIENCE FOODS

Mr. FLOOD. With the advent of frozen food as a common household item, and the unfreezing and refreezing, is this a problem? Does this bother you much?

Dr. GODDARD. This is an area we are paying increased attention to. Mr. FLOOD. It is disappointing to realize even in the plush restaurant so much, much, much of the food is little more than TV dinners. I understand this is one reason this last chef left the White House— too much frozen food for his liking.

What sort of a problem is this, if it is a problem?

Dr. GODDARD. In our present budget request we do ask for funds to carry out additional research because there is concern about the so-called convenience foods and frozen foods would be one example.

The assumption is often made that directions will be followed precisely. However, we are well aware that not everyone at all times follows the precise directions as far as handling is concerned. We wish to find out what impact this has and study these "convenience" foods in greater detail.

Mr. FLOOD. Have we run onto any bad problems that have disturbed your shop any place in this country?

THE SMOKED FISH PROBLEM

Dr. GODDARD. In a somewhat analogous area, the smoked fish episode of 1964, I believe would be an example of this type of occurrence that was really one of great concern.

Mr. FLOOD. Are those people back on the track yet like the cranberry people? How are the cranberry people? Are they all right now? Has it blown over?

Mr. DUNCAN. Yes.

Mr. FLOOD. We have always had cranberry juice around.

Mr. DUNCAN. Their market has been recovered. They were hurt very badly.

Mr. FLOOD. Do you not have them in New England?

Mr. FOGARTY. Yes.

Mr. FLOOD. In our house, we went right through it as though nothing happened. I would pick up the paper and read, and drink the juice.

Dr. GODDARD. To get back to the fish problem, we are continuing studies on the matter of botulism in fish. We have research contracts with universities.

Mr. FLOOD. Did those people recover from their shock?

Dr. GODDARD. I do not know what the economic situation is with respect to the smoked fish industry.

Mr. FLOOD. What area was involved?

Dr. GODDARD. The Great Lakes area involving smoked whitefish.

ADDITIVES

Mr. FLOOD. Speaking about having a tiger in your tank in the gasoline field, what about you fellows and additives?

Dr. GODDARD. Any particular part of the additive problem?

Mr. FLOOD. No; just the whole field of additives. Is this something to worry about?

Dr. GODDARD. It does come into our area of jurisdiction.

Mr. FLOOD. What do you examine, the additive, or final package? Dr. GODDARD. Both. The manufacturer must submit evidence the additive he proposes to use is safe, and he must carry out certain types of studies.

Mr. FLOOD. What is an additive-"Exhibit A"?

Dr. GODDARD. I would like to submit the technical definition of an additive.

Mr. FLOOD. You can to that.

Dr. GODDARD. It is something used by the manufacturer to enhance the color, stabilize the product, make it more usable in terms of having a longer storage life. It is often a chemical compound. An additive would be a dye. It is intentionally put into the food product for a specific technological purpose by the manufacturer.

(The technical definition was submitted as follows:)

DEFINITION OF A FOOD ADDITIVE

The term "food additive" is defined on page 201 (u) of the Federal Food, Drug, and Cosmetic Act, as amended, 1960, as "any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use), if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use of food) to be safe under the conditions of its intended use." The law goes on to exclude certain items that are treated elsewhere, such as a pesticide chemical in or on a raw agricultural commodity or used in the production, storage, or transportation of any raw agricultural commodity, a color additive, or any substance approved for use by the Poultry Products Inspection Act, the Meat Inspection Act, or the Food, Drug, and Cosmetics Act.

This definition encompasses literally hundreds of food additives-from such obvious things as flavors, preservatives, and such supplements as vitamins and minerals, to subtler things like the chemicals found in various packaging materials or in the machinery used to manufacture and store food products.

PESTICIDES

Mr. FLOOD. That invites an inquiry about the whole broad realm of pesticides?

Dr. GODDARD. Yes.

Mr. FLOOD. This is apparently your current No. 1 headache. L Dr. GODDARD. One of them.

Mr. FLOOD. With movies, books, stage plays, lectures and ladies' clubs, you have had a bear by the tail.

Dr. GODDARD. It is a significant problem for all of us as consumers to bear in mind and particularly the Food and Drug Administration must monitor this field along with other responsible agencies. The last report which I saw last week indicated that the impact of pesticides on humans was not increasing, and that the amount of pesticides stored in human tissues was either holding constant, or decreasing, which is a favorable sign.

In general, great efforts are being made to learn to use these in a way which will result in smaller residues on the crop being marketed, and a variety of techniques are used.

Mr. FLOOD. It is a vicious circle.

If we are going to feed the world, we have to do this, and if we do this, we get that, and if we get that, here we go again.

Dr. GODDARD. Sir, I would not characterize it as a vicious circle. Mr. FLOOD. Strike out the word "vicious".

Dr. GODDARD. Certainly, each new introduction poses new kinds of problems, and it is our job to make certain these do not have a deleterious effect on health.

INTERNATIONAL COMMERCE

Mr. FLOOD. To what extent, if any, do you get into the field of international commerce? What about foreign drugs, imports, and so forth?

Dr. GODDARD. We are involved in international commerce in that sense. We are responsible for determining that both food and drugs. imported into this country meet the standards our manufacturers must comply with.

We do carry out in the field of drug imports, inspection of plants in which these drugs are manufactured, and sample, if it involves insulin or antibiotics, the batch-by-batch process that they carry out.

PREPARATION FOR IMPACT OF MEDICARE

Mr. FLOOD. With the advent of medicare, and its impact on our medical facilities and services, are you getting ready for the blow that will follow from this?

Dr. GODDARD. We are planning, sir, to have a vigorous program in attempting to educate the persons in the older age groups so they will have a more intelligent knowledge of what medicines can do for them. Many of these people purchase over-the-counter remedies. We would like to help educate them on the worth of medicines in general and do a better job of consumer education for them.

SOPHISTICATED TECHNIQUES TO MATCH COMPLEX INDUSTRY

Mr. FLOOD. It strikes me you are on the threshold of an extremely difficult few years.

Dr. GODDARD. Yes.

Mr. FLOOD. With the advent of medicare.

Dr. GODDARD. I would not limit it to the advent of medicare. I think the nature of the industries we regulate is that they are becoming increasingly complex. There are many interrelationships.

Whether we are talking about effects of multiple pesticides on different foods, or the new drugs being developed, they often are designed for use over long periods of time. This means that we must have more sophisticated techniques to assess the impact of these on our citizens.

COOPERATION WITH NARCOTIC SQUADS ON DRUG ABUSE

Mr. FLOOD. How closely do you work with the enforcement people of the narcotic squads on the abuse of the use of narcotics-drugs generally?

I had in mind narcotics in particular, but drugs.