Pub H * 094666-5 17/22/87 FDA'S REGULATION OF CARCINOGENIC ADDITIVES WEDNESDAY, JUNE 24, 1987 HOUSE OF REPRESENTATIVES, INTERGOVERNMENTAL RELATIONS SUBCOMMITTEE OF THE COMMITTEE ON GOVERNMENT OPERATIONS, Washington, DC. The subcommittee met, pursuant to notice, at 9:34 a.m., in room 2154, Rayburn House Office Building, Hon. Ted Weiss (chairman of the subcommittee) presiding. Present: Representatives Ted Weiss, Thomas C. Sawyer, John Conyers, Jr., Jim Lightfoot, and Ernest L. Konnyu. Also present: James R. Gottlieb, staff director; Daniel W. Sigelman, counsel; Gwendolyn S. McFadden, secretary; and Mary Kazmerzak, minority professional staff, Committee on Government Operations. OPENING STATEMENT OF CHAIRMAN WEISS Mr. WEISS. Good morning. The Human Resources and Intergovernmental Relations Subcommittee is now in session. Let me say at the outset that the House will be going in at 10 a.m. I hope we will not have too many interruptions, but we never can predict that. We will move as expeditiously as possible under the circumstances. Today the subcommittee will conduct an oversight hearing on the Food and Drug Administration's [FDA's] regulation of carcinogenic additives. In 1982 and 1983, FDA scientists concluded that six color additives caused cancer in animals. Because the Delaney anticancer clause prohibits the use of food or color additives found to "induce cancer in man or animal," three successive FDA Commissioners, including the incumbent, have recommended banning some or all of these additives. To date, only one of these additives has been banned. In June 1985, the full Government Operations Committee unanimously concluded that the failure to ban all of these colorants plainly violated the law. Later that same month, FDA declared that it was prepared to approve cancer-causing additives which, on the basis of quantitative risk assessment, it regarded as posing “de minimis" or insignificant cancer risks to humans. By that time, FDA had already acknowledged that several color additives induced cancer in appropriately conducted animal studies. In February of this year however, FDA, apparently at the di rection of the Justice Department, proclaimed that two of the dyes-D&C Orange 17 and D&C Red 19-although demonstrated animal carcinogens, nonetheless did not "induce cancer" within the meaning of the Delaney clause. As a result of the new policy established by FDA's February statement on Orange 17 and Red 19, FDA's scientists are no longer the final judges of whether a food or color additive "induces cancer." Now, FDA's lawyers, not its scientists, will decide when an additive can be regarded as carcinogenic within the meaning of the Delaney clause. I believe the relegation of agency science to such a subsidiary role is poor policy and not consistent with the legislative history of the Delaney clause. In 1985, the Committee on Government Operations documented that the Department of Health and Human Services (HHS) and possibly the Office of Management and Budget (OMB) prevented a succession of FDA Commissioners from banning some or all of six cancer-causing dyes. The carcinogenic color additives present a textbook case of the unprecedented degree to which FDA's dedicated career scientists and regulators have been undermined in recent years by executive branch political appointees. The result we have seen is that FDA regulatory decisions are often not supported by the law or the scientific evidence. The Justice Department declined our invitation to appear today, as did OMB 2 months ago when the subcommittee reviewed new proposed regulations on experimental drugs that OMB had foisted on FDA. [Relevant correspondence between the subcommittee and the Justice Department is in app. 1, p. 69.] Mr. WEISS. Unless the public can remain confident that FDA's decisions reflect the best judgment of its dedicated cadre of professional experts and comport with the requirements of law, continued erosion of the agency's scientific and regulatory credibility is inevitable. In testimony central to the legislative history of the Delaney clause, then HEW Secretary Arthur Flemming stated in 1960 that the issue of whether some carcinogenic color additives should be approved for use "is so important that the elected representatives of the people should have the opportunity of examining the evidence and determining whether or not the authority should be granted." Every administration before the current one has agreed that only Congress could revoke or make exceptions to the Delaney clause. We are not here to debate the merits of this clause, but rather to ascertain why the executive branch has taken it upon itself to undermine the laws that Congress has enacted. Because of our conflicting schedules, members of the subcommittee will be coming in during the course of the morning, at which time we will recognize them for any opening comments that they may have. Our first panel of witnesses consist of two very eminent authorities in the field of carcinogenesis and cancer risk assessment, Dr. Norton Nelson and Dr. Roy Albert. Would you gentlemen please approach the witness table? It is the tradition of this subcommittee to swear in all of its witnesses. Thus, before you sit down, I ask that you raise your right hand to be sworn. 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 indicate that each witness responded in the affirmative. Dr. Nelson is considered by many as the dean of environmental health science in the United States. Few, if any, persons have rendered more advice to the Federal Government on toxicological and environmental health matters than Dr. Nelson. Dr. Nelson is currently professor of environmental medicine in the Institute of Environmental Medicine, NYU Medical Center. Dr. Nelson was formerly director at that institute as well as chairman of the Department of Environmental Medicine, NYU Medical Center. Dr. Roy Albert is particularly well-known for his early contributions to the use of quantitative risk assessment. Dr. Albert is widely recognized, in fact, as the father of risk assessment at the Environmental Protection Agency. Dr. Albert is professor and chairman, Department of Environmental Health, University of Cincinnati Medical Center. I would like very much to welcome both of you here and to express the committee's appreciation for taking time from your very busy schedules to share your expertise with us. It is my understanding that you, Dr. Nelson, have a prepared statement, which will be made a part of the record. You may read or summarize that statement, whichever you deem more appropriate. STATEMENT OF NORTON NELSON, PH.D., PROFESSOR OF ENVIRONMENTAL MEDICINE, INSTITUTE OF ENVIRONMENTAL MEDICINE, NEW YORK UNIVERSITY MEDICAL CENTER Dr. NELSON. Thank you, Mr. Chairman. And, with your permission, I will summarize the statement. Mr. WEISS. Thank you. Dr. NELSON. And request that it be placed into the record. Dr. NELSON. You have introduced me, so I will not take time to repeat that. I have read the Federal Register notices relating to Orange 17 and Red 19. I will not comment here on the legality of the position that FDA has taken. This is not in my realm of expertise; I am not capable of commenting. I must say that I have read Dean Merrill's statement, which is rather extensive, on this issue, and I would certainly defer to someone of his eminence and skill and understanding of the legal issues here, and I have great respect for his judgment. I, however, would like to comment on the science, the language and the possible misuse of the actions taken in the decisions regarding these two colors. I find the language in which the newer and revised decisions were made convoluted. I do not really understand it. I find the reasoning circular, and I think potentially dangerous to possible misuse in not only this issue, which may be relatively inconsequential as far as broad public health issues are concerned, but in other issues of greater weight. The facts are straightforward. The colors have been found to be carcinogenic in animal studies that I presume to be competent, rection of the Justice Department, proclaimed that two of the dyes-D&C Orange 17 and D&C Red 19-although demonstrated animal carcinogens, nonetheless did not "induce cancer" within the meaning of the Delaney clause. As a result of the new policy established by FDA's February statement on Orange 17 and Red 19, FDA's scientists are no longer the final judges of whether a food or color additive "induces cancer." Now, FDA's lawyers, not its scientists, will decide when an additive can be regarded as carcinogenic within the meaning of the Delaney clause. I believe the relegation of agency science to such a subsidiary role is poor policy and not consistent with the legislative history of the Delaney clause. In 1985, the Committee on Government Operations documented that the Department of Health and Human Services (HHS) and possibly the Office of Management and Budget (OMB) prevented a succession of FDA Commissioners from banning some or all of six cancer-causing dyes. The carcinogenic color additives present a textbook case of the unprecedented degree to which FDA's dedicated career scientists and regulators have been undermined in recent years by executive branch political appointees. The result we have seen is that FDA regulatory decisions are often not supported by the law or the scientific evidence. The Justice Department declined our invitation to appear today, as did OMB 2 months ago when the subcommittee reviewed new proposed regulations on experimental drugs that OMB had foisted on FDA. [Relevant correspondence between the subcommittee and the Justice Department is in app. 1, p. 69.] Mr. WEISS. Unless the public can remain confident that FDA's decisions reflect the best judgment of its dedicated cadre of professional experts and comport with the requirements of law, continued erosion of the agency's scientific and regulatory credibility is inevitable. In testimony central to the legislative history of the Delaney clause, then HEW Secretary Arthur Flemming stated in 1960 that the issue of whether some carcinogenic color additives should be approved for use "is so important that the elected representatives of the people should have the opportunity of examining the evidence and determining whether or not the authority should be granted." Every administration before the current one has agreed that only Congress could revoke or make exceptions to the Delaney clause. We are not here to debate the merits of this clause, but rather to ascertain why the executive branch has taken it upon itself to undermine the laws that Congress has enacted. Because of our conflicting schedules, members of the subcommittee will be coming in during the course of the morning, at which time we will recognize them for any opening comments that they may have. Our first panel of witnesses consist of two very eminent authorities in the field of carcinogenesis and cancer risk assessment, Dr. Norton Nelson and Dr. Roy Albert. Would you gentlemen please approach the witness table? It is the tradition of this subcommittee to swear in all of its witnesses. Thus, before you sit down, I ask that you raise your right hand to be sworn. 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 indicate that each witness responded in the affirmative. Dr. Nelson is considered by many as the dean of environmental health science in the United States. Few, if any, persons have rendered more advice to the Federal Government on toxicological and environmental health matters than Dr. Nelson. Dr. Nelson is currently professor of environmental medicine in the Institute of Environmental Medicine, NYU Medical Center. Dr. Nelson was formerly director at that institute as well as chairman of the Department of Environmental Medicine, NYU Medical Center. Dr. Roy Albert is particularly well-known for his early contributions to the use of quantitative risk assessment. Dr. Albert is widely recognized, in fact, as the father of risk assessment at the Environmental Protection Agency. Dr. Albert is professor and chairman, Department of Environmental Health, University of Cincinnati Medical Center. I would like very much to welcome both of you here and to express the committee's appreciation for taking time from your very busy schedules to share your expertise with us. It is my understanding that you, Dr. Nelson, have a prepared statement, which will be made a part of the record. You may read or summarize that statement, whichever you deem more appropriate. STATEMENT OF NORTON NELSON, PH.D., PROFESSOR OF ENVIRONMENTAL MEDICINE, INSTITUTE OF ENVIRONMENTAL MEDICINE, NEW YORK UNIVERSITY MEDICAL CENTER Dr. NELSON. Thank you, Mr. Chairman. And, with your permission, I will summarize the statement. Mr. WEISS. Thank you. Dr. NELSON. And request that it be placed into the record. Dr. NELSON. You have introduced me, so I will not take time to repeat that. I have read the Federal Register notices relating to Orange 17 and Red 19. I will not comment here on the legality of the position that FDA has taken. This is not in my realm of expertise; I am not capable of commenting. I must say that I have read Dean Merrill's statement, which is rather extensive, on this issue, and I would certainly defer to someone of his eminence and skill and understanding of the legal issues here, and I have great respect for his judgment. I, however, would like to comment on the science, the language and the possible misuse of the actions taken in the decisions regarding these two colors. I find the language in which the newer and revised decisions were made convoluted. I do not really understand it. I find the reasoning circular, and I think potentially dangerous to possible misuse in not only this issue, which may be relatively inconsequential as far as broad public health issues are concerned, but in other issues of greater weight. The facts are straightforward. The colors have been found to be carcinogenic in animal studies that I presume to be competent, |