ment, is a small step, I think it steps over the line at the point when it goes contrary to the will of the Congress. You link up this development with much larger developments in other areas of Government activity; I think it is fair to say that in some areas of the administration there is an insufficient respect for the Congress. Mr. CONYERS. Well, I was thinking even historically. This isn't just new with this administration versus the Congress. We have had this question during the Vietnam area of the President's authority versus the Congress. It is continuing and I concede that it is historical, but it does seem to me, as one who has been up here, that we almost are under some sort of an assault, or maybe a siege even. That almost at every step we have to go back into this fight between this authority, and I think that the Congress is losing to the last of the constitutional democracy concept of the three parts of Government. I don't see it as healthy, this drainage of power, which I would argue could be proved over almost any period of time, going beyond this administration. That we keep going back to let the executive branch make the decision. Mr. COOPER. I served in the executive branch in the late 1970's. The view was a little different from that vantage point. At that time, the Congress looked awesomely powerful to someone sitting at FDA. The kind of process we are engaged in this morning, oversight, is a perfectly appropriate, desirable and healthy way for the Congress to react when it believes that the executive branch has overstepped the bounds or taken inappropriate actions. It is a part of the genius of our institutions under the Constitution that each branch is given certain powers and weapons to use against the other branches to check abuses of power. I think oversight is certainly a very, very important one and can be effective, and the ultimate judges are the American people. Mr. CONYERS. I am glad you could come before us today. Thank you, Mr. Cooper. Mr. WEISS. Thank you, Mr. Conyers. Mr. Konnyu. Thank you very much, Mr. Cooper. Let me just also add my appreciation to the two of you for the colloquy that you have just engaged in, because our concern goes beyond the immediate public health concerns at issue here. We are not really passing judgment on the wisdom of reviewing the merits of the Delaney clause. Rather, we are concerned that whatever changes might take place are done within the constitutional framework. Mr. Conyers referred to today's headlines regarding alleged violations of the Boland amendment. This represents exactly the same kind of thing in a different arena. I believe that we, as Americans, engage at our own peril when we denigrate adherence to congressional mandates. If you want to change policy, you have the right to do it by attempting to change the law. But once the law is adopted and signed by the President, it is not up to an executive branch agency to try to find some cute way around it. I believe that, ultimately, that course is destructive, not only to the relationship between Congress and the executive branch, but also to the whole constitutional framework within which we operate. I thank you very, very much for some very important testimony. Mr. COOPER. Thank you, Mr. Chairman. Mr. WEISS. We are now ready to proceed with the testimony from representatives of the Food and Drug Administration. Dr. Young, if you will come forward with your associates and have them identify themselves for the record. They should remain standing for the oath. Dr. YOUNG. On my immediate right is Mr. Scarlett, general counsel. Next to him, Dr. Miller, Director of the Center for Food Safety and Applied Nutrition. On my immediate left, the deputy, Mr. Ronk. And next to him, Dr. Flamm, who is the major person involved in our toxicology programs. Mr. WEISS. Thank you. Do you affirm that the testimony you are about to give will be the truth, the whole truth, and nothing but the truth? Let the record show that each of the witnesses responded in the affirmative. Before proceeding, I want to note that the agency will soon be losing one of its finest managers. Dr. Sanford Miller, who, for the past decade, has served the public with dedication, professionalism, and integrity as Director of FDA's Center for Food Safety and Applied Nutrition-formerly known as the Bureau of Foods-will be retiring from the agency next month to assume a new challenge in academia. Dr. Miller, although we are very sorry to see you leave, we wish you the very, very best in your future endeavors. It has been good having you working for all of us and all of the American people. Dr. Young, I understand that you have a prepared statement. As you know, you may read that statement or portions thereof, or summarize it. Without objection, the entire statement will be entered into the record. STATEMENT OF FRANK E. YOUNG, M.D., PH.D., COMMISSIONER, FOOD AND DRUG ADMINISTRATION, ACCOMPANIED BY THOMAS SCARLETT, CHIEF COUNSEL, FOOD AND DRUG DIVISION, OFFICE OF THE HHS GENERAL COUNSEL; SANFORD A. MILLER, PH.D., DIRECTOR, CENTER FOR FOOD SAFETY AND APPLIED NUTRITION (CFSAN); RICHARD J. RONK, DEPUTY DIRECTOR, CFSAN; AND W. GARY FLAMM, PH.D., DIRECTOR, OFFICE OF TOXICOLOGICAL SCIENCES, CFSAN Dr. YOUNG. Thank you, Mr. Chairman. And, as I mentioned to you earlier, before I make my formal remarks I would like to acknowledge the leadership that Dr. Miller has made over his years of service in the Center for Food Safety and Applied Nutrition. He has been a dedicated academician who left academe and has served, as he has told me, not as originally planned for just two years, but for many years more. I am pleased that the agency has been able to capture him, to have him serve so long and effectively, and I want him, you, and the Nation to know that he will be sorely missed. It is the dedication of individuals like Dr. Miller, who leave their secure and tenured posts in academe to come to the vortex of controversy to engage in these very important issues, that the American people are really indebted to. Mr. WEISS. It is nice to know that there are some things on which we can have very strong agreement. Dr. Miller is one of those. Go ahead, Dr. Young. Dr. YOUNG. Thank you very much, Mr. Chairman. I am particularly delighted in this year of celebration of the Bicentennial of the Constitution to focus on the issues of discussion here. I would also add, as was added by Mr. Conyers, that there are three branches of Government, and I look forward to the resolution of this interesting discussion in the not too distant future in the courts. I would also agree with my distinguished colleague who was here before that it is the administration that is sitting probably at least 2 feet below the dais on which you are sitting, and from this end of the table it does not look as if Congress has few powers, particularly in oversight hearings, which I feel are very important and again a part of our participatory Government. And with that stated clearly, I would like to now move to my very few comments in the beginning. Mr. Chairman and members of the committee, I am here to focus on one seminal issue. I wish to state clearly there was no change either in our scientific judgment or the way in which we conduct scientific analyses. My testimony describes in detail the reason for the action on February 19, 1987, and the conceptual framework in which it occurred. Simply, it was a legal clarification, and I believe that that point was addressed very clearly in the early portions of the testimony and was addressed by Mr. Cooper when he focused on the fact that he did not feel that he disagreed with the policy but was concerned in the actions that were taken. And I would like to introduce for the record, sir, his complete chronology in the article that was published in Regulation, which I consider a very scholarly article, and my rebuttal to it in a letter to the editor, which is equally scholarly in my opinion-and I think Mr. Cooper's-that outlines our points of disagreement as we go forward on this. First, I would like to state that there has been a marked increase in the sensitivity of methods of analysis since 1960. In fact, we can assay one part in a million trillions, or roughly 6 molecules in a gram. That is an extraordinarily sensitive analysis. And I would contend that FDA has not made any decisions that cause additional risks to human health, nor do the decisions mean that FDA will be any less vigilant than it has been in the past from protecting the public from products that may pose carcinogenic risks. In fact, the clarifications did not represent a change in agency policy or scientific judgment with respect to the regulation of animal carcinogens. Instead, the Federal Register notice clarified the agency's legal interpretation in that it made explicit one of the implicit legal underpinnings of the FDA's decision to list permanently the two color additives. That is, where the risk to humans posed by a carcinogen is negligible, the risk to animals at a comparable level of exposure is also negligible. The substance does not induce cancer under those circumstances within the meaning of the Delaney clause. I would emphasize here that I am discussing the question of a strictly legal interpretation of the Delaney clause that has been confounded by the fact, as I mentioned in my first point, that the increase in sensitivity of methods now enable us to detect essentially 6 million molecules in a gram, a very low level of sensitivity. My second point is that we contend that the agency has been steadfastly increasing its reliance on quantitative risk assessment as this science has progressed. Therefore, the constituents policy, which Mr. Cooper mentioned, and the approval of lead acetate, a carcinogen in hair dyes, are only two recent forerunners of the approach that led to our de minimis policy. And I would concur with Mr. Cooper that this policy did not drop full-born from the head of Zeus, but instead was an additional pathway, an additional step on a long road that has led us to this point. One of my first decisions that I had to face, even before the hearing that I shared with you at my first hearing, which was on colors, nigh these many years ago, was the decision on acrylonitrile; and it was clearly stated in that decision, as Mr. Cooper focused, that that acrylonitrile was a carcinogen, and I was asked to rule whether it was safe. It has been viewed as a seminal decision both in his article which I introduced for the record and right now in my statement. A recent report of the National Academy of Sciences recommended that a negligible risk standard be applied consistently to all pesticides, and all forms of foods that are subject to pesticide exposure. And I would request that the relevant pages of that Academy report be also inserted into the record. [The pages referred to follow:] |