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A proposal to establish a national science council for peer review of decisions reached by regulatory agencies
FUNDAMENTAL AND APPLIED TOXICOLOGY 2:272.275 (1982}
A Proposal to Establish a National Science Council for Peer Review of Decisions Reached by Regulatory Agencies THE HONORABLE WILLIAM C. WAMPLER Member of Congress, U.S. House of Representatives, 2407 Rayburn House Office Building, Washington, DC 20515
Fellow panel members and members and guests of the Society of Toxicology, it is a real honor and pleasure for mo to participate in this symposium. I say that very honestly because the subject we are discussing today has been one of the focal points of my legislative activity. In brief, 1 believe that scientific judgments must be a vital part of our regulatory decision making. Further, I believe that peer review of the effect of those regulations is necessary to insure proper oversight. Congress has a responsibihty not only to pass laws but to oversee whether and how those laws are being carried out. If they are not being carried out or the resulting regulations are not meeting the test of effectiveness, you can be sure that those of us in the Congress hear about it. I can cite several recent regulatory actions by the Executive Branch to ban certain chemicals which caused a rash of communications to the members of the Congress to have these proposals either reconsidered or to change the law which allowed such actions. Cases in point are proposals by the Food and Drug Administration to ban saccharin and nitrites, and a proposal by the Envfronmental Protection Agency to ban the herbicide, 2,4,5-T. Citizens, groups and industries which have taken issue with the actions of the;r government in these case~ want protection of the=r health and the environment and they generally support the goals of these laws. But at the same time, many of them have conceived, rightly or wrongly, that the interpretation of these laws by the executive branch was high-handed, was against their interest, or was not based on reasonable, supportable, or valid evidence. In many cases, scientists themselves were divided as to whether or not there was a risk to humans at all. Or, if there was a risk. to what degree was it a risk? Was it more of a risk to a particular class of persons or was it a risk to all humans? And many scientists were concerned about the methodology and validity of the system used to establish the risk cited. Moreover, different agencies of government had varied ideas as to how to determine risks and, once they were determined, different policies for regulating a specific substance. On top of this confusion, science and technology, itself, confused the w h o l e issue by advancing their own capability to detect the presence of smaller and smaller amounts of a given substance. When the so-called "Delaney Clause" was made a part of the Food. Drug and Cosmetic Act in 1958, technology was only able, I am informed, to determine the presence of a substance w i t h reliability in parts per million. As you are quite aware, this capability has skyrocketed in the last few years to parts per billion and only recently, I have again
been informed, to Darts per trillion. This whole advance in detection has suddenly, at least in my view, created a nightmare. Foods, chemicals, wor'k habits, and even things found in nature thought by most of us to be reasonably safe to human health or the environment, are now suspect based on testing methods now being used to implement the zero tolerance theory brought on by the "Delaney Clause." This advance in technology has had much to do with what I call the "'Delaney Syndrome," and caused some to jest that apple pie, Chevrolet. and even motherhood might be hazardous to healtl~ and the environment if Delaney was applied on a absolute basis. How do peer review and sc=entific decision making fit into this political process? How does the Congress conceive the role of scientific and technical information in environmental decision making? Let me trace for you some of the milestones that have caused me to be particularly concerned with the role of science in regulatory decision making, During the 94th Congress, which held sway during the 1975-76 period, a number of us on the House Committee on Agriculture heard reams of testimony during our oversight hearings or~ the manner in which the Environmental Protection Agency was administering the Federal Insecticide, Fungicide an6,R#denticide ,attt. commonly called FIFRA, or the Pesticide Act. It was charged during these hearings by agricultural interests that EPA was considering the cancellation of numerous already registered pesticides before adequately considering the risk or the benefits of these pesticides to control pests on crops and animals. The argument was not against the right of EPA to cancel a registration, but on the question of h o w EPA arrived at its decisions to announce that they were either going to ban these pesticides or consider banning them. Many thought that EPA was not gefierating, acquiring, end using technical information to the necessary extent to arrive at a proper decision nor at the state that scientific knowledge allowed. Those concerned about the use of science in regulatory decision making were of the opinion that many of these questions were purely scientific in nature. Moreover, others thought that EPA, after considering the scientific question, was not balancing off the risk to human health or the environment against the economic and social questions of the benefits the pesticide might have for protecting our food supply and providing it at a cost that society felt was proper and which all could afford. Those w h o opposed the necessity for peer review and a balancing of risks against benefits were of the. opinion that scientists didn't have all the answers to these scientific ques-
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PEER REVIEW FOR SCIENTIFIC DECISION MAKING tions and that if we must err they wanted to err on the side of human health and the environment. They further argued that EPA had its own scientists who were perfectly capable of making any scientific input that was necessary. A compromise was finally reached and the pesticide law was amended to require the administrator of EPA to submit all actions for proposed cancellations of pesticides to an independent scientific advisory panel for peer review comments as to the impact on health and the environment of such a proposed action. The scientific advisory panel's independence was assured by requiring the administrator to appoint seven members from a list of twelve nominees, six nominated by the National Institutes of Health, and six by the National Science Foundation. Conflicts of interest were resolved by requiring the disclosure of financial, employment and professional affiliation of each nominee. Additionally, the names, addresses and professional affiliations of nominees were published in the Federal Register. So as not to tie the hands of the administrator in emergency suspension cases, grovisions were made to allow the administrator to skip the submission of the scientific and technical data to the scientific panel for comment during emergencies. This exception to the pea.', eview requirement became an issue in the action of the administrator in his emergency suspension nf the Herbicide 2,4.5-T in 1979, when the EPA cited the so-called ALSEA studies as grounds for an emergency suspension of this Herbicide. Since this was an emergency action, the peer review process was bypassed. The ALSEA findings alleged that young women who lived near a forest area in Oregon suffered spontaneous abortions shortly after the forest had been sprayed with 2,4,5-T. The case was also complicated by the allegation that a contaminant, dioxin, associated with Agent Orange, a Vietnam war defoliant, had been found in earlier production runs of 2,4.5-T. It made little difference that the contaminant, dioxin, had been reduced to an insignificant amount in later production runs; those opposed to general pesticide use still branded 2,4,5-T as Agent Orange. The forest industry and independent scientists from numerous walks of life complained publicly that the ALSEA study was flawed as to design, conduct, and statistical interpretation. The scientific advisory panel, in a meeting with me which 1 requested in order to determine if any changes needed to be made to the law, stated that t he 2,4,5-T case showed a flaw in the peer review process. They based their view as a result of their informaT review of the ALSEA data where they concluded that the data appeared to be flawed and at least should have a stiff scientific review. Moreover. the panel said their review could have been accomplished in sufficient time and would not have hindered the proceedings of the administrator of EPA to apply an emergency action. Finally, the panel stated that they should still review the scientific evidence, since the law required the administrator to initiate a full cancellation action, with all its protection to the rights of all parties, once an emergency suspension action had been taken by EPA. However, EPA said the law did not require peer review in this case by the panel because this was an emergency suspension. But when EPA attempted to extend the 2,4,5-T emerFundament,,! and Applied Toxicology
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gency suspension to rice and grazing lands, preparatory to a final cancellation, pressure had budt sufficiently against EPA to send the scientific evidence to the panel for review and comment. The result - - the Scientific Advisory Panel held that there was insufficient scientific evidence to show an impact on health and the environment for the use of 2,4,5.T to control plant pests in the growling of rice and the sustenance of good grazing lands. However, EPA continued its action against 2,4,5-T, but subsequently held that the ALSEA studies were no longer the basis for its action and that other evidence was being used as the basis for the cancellation action. The case is currently before an administrative law judge for a decision on the matter. However, the judge has suspended the hearings and has directed the parties to arrange a compromise on the que,~tion. This compromise effort is still underway and it appears that the end result will be -- not cancellation of 2,4,5-T as originally sought by EPA, but some form of restriction on the manner in which the cllomical is used in forests. In December, t 980, the Pesticide Law was again amended by Congress in a substantial upgrading of EPA's Scientific Advisory Panel Peer Rewew Authority. The amendment re, quired the administrator of EPA by written procedures to provide for peer review of the design, protocols and conduct of all major scientific studies conducted by EPA to regulate under the Pesticide Act. Moreover, the new act required peer review by the Scientific Advisory Panel of the Resul',s of any such action relied upon by the Administrator to classify, suspend, or cancel any pesticide regulated by the Agency. The amendment to the law also permitted the Scientific Advisory Panel to nominate a list of other experts to assist either the panel or EPA in its peer review processes. Further. the amendment recognized the authority of the administrator to act in emergency situations by allowing the agency to bypass temporarily the peer review processes. But the administrator was required to promptly provide thereafter for the conduct of peer review of the action by the scientific advisory panel. To further strengthen the peer review process, the amendment also required the evaluations and the relevant documentations constituting the peer review of the proposed scientific studies and the result of the completed scientific studies to be included in the published comments which the administrator makes in any final regulatory decision under the pesticide act. Was "Peer Review" necessary in the 2.4,5-T case? I think the facts speak for themselves. The other cases which have strengthened the peer review requirement in regulatory decision making are the Nitrite Case and the Saccharin Case. I shall discuss them briefly. In the Nitrite Case, the Food and Drug Administration proposed a ban on the food additive, nitrite, following an announcement of an alleged highly ,~uccessful laboratory study at the Massachusetts Institute of Technology. The study, commissioned by FDA under a Dr. Newberne, involved the long-term feeding of nitrites to rats in an allegedly highly controlled condition. According to FDA's initial announcement, the study showed a significant number of rats had developed cancer to invoke the Delaney Clause. The meat industry also claimed that nitrite prevented botulism during storage and distribution of meat, as 273
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well as giving meats certain tastes and color. A hue and cry also arose against the ban proposal from the public and a number of scientists urging FDA to take a second look at the Newberne Study. Also, a number of members of Congress, responding to these criticisms, demanded that an outsider peer review of the Newberne studies be conducted. I must admit that I was among those members demanding a complete review of the Newbcrne study. My interest was heightened by leaks to me from within FDA itself. These leaks informed me that Dr. Newberne's Lab had flunked an audit of laboratory procedures, that FDA itself had strayed from its own standards and had not conducted its own scientific review of the MIT test (a Library of Congress study), and that Government scientists who had viewed some of the study slides, which Dr. Newberne had alleged showed cancerous cells in the test rats, disagreed with Dr. Newberne's conclusions. This whole affair was compounded when meat scientists throughout the country stated there was no known substitute for nitrite that would prevent botulism. Particularly, the Council on Agricultural Science and Technology (CAST), which reviewed the Newberne study and also did a detailed effects study on alternatives to the use of nitrite that could prevent botulism, announced a position higl~ly supportive of the meat scientists" view. Specifically, CAST felt that there was not an available substitute for nitrite and that additionally, Dr. Newberne's study had a sufficient number of flaws to require a complete review before it could be used as a basis for regulatory decision making, At this stage of the game we were faced with two problems. The first, was the Newberne study sufficiently valid from a scientific basis to show a risk to human health? The second, if Dr. Newber ne's study was valid, would banning nitrites create an additional and perhaps a morP.severe risk, that of botulism? T;" make a short story out of this massive and protracted bureaucratic blunder, and 1believe it was just that, Commissioner Kennedy of FDA announced he was contracting with an outside scientific group, Universities Associated for Research and Education in Pathology (UAREP), to review all the 40,000 slides that Dr. Newberne had collected during his lengthy nitrite study. UAREP's blind study turned thumb's-down on Dr. Newberne°s interpretations of those slides he alleged showed cancer in his test rats. Just recently, The National Academy of Sciences published a report, "'The Health Effects of Nitrate, Nitrite and n-Nitroso Compounds," commissioned in September, 1980 by the Department of Agriculture and the Food and Drug Administration to examine the health effects of dietary nitrate and nitrite and to evaluate possible alternatives to nitrites added to food as a preservative. The first report, completed in December, 1981, dealt only with the risks resulting from natural and added nitrite in food. In accomplishing this task. the Academy was to examine all the scientific literature pertaining to this subject. The second study, on alternative to nitrite, is still underway. The Academy's recommendations state specifically with respect to nitrite: "Evidence does not indicate that n/trite acts ~ directly as a carcinogen in animals." This in effect confirms UAREP's negative evaluation of Newberne's study. However, 274
the Academy goes on to state: "however, because it is a mutagenic in microbial systems end because of its implied role in the induction of esophageal and stomach cancer in humans, further testing in animals may be warranted. If such tests provide any indication of carcinogen/city, then the committee recommends that attempts be made to distinguish between the types of carcinogenic activity, i.e., activity as a complete carcinogen, cocarcinogen, or promoter." While the Academy did not give nitrite an absolutely clean bill of health, it did not recommend its banning, but instead suggested reductions in its use in high quantities; the use of inhibitors or blocking agents, such as ascorbate, to reduce nitrite's ability to form nitrosamines; end further studies and research to find an alternative to nitrite. Was "Peer Review" in the nitrite case necessary? I think the facts speak for themselves. As to my last example of the need for peer review, let's turn to the saccharin case. As a result of scientific tests, which showed carcinogen/city in test animals, saccharin, an artificial sweetener in wide use, was proposed for banning by the Food and Drug Administration. As a national food issue the banning of saccharin was without precedent. The pressure on Congress to halt FDA's proposed action was, to say the least, terrific. A bill was proposed and quickly passed to place an eighteen-month moratorium on FDA, preventing that agency from banning saccharin while the National Academy of Sciences studied the issue. The Academy's study concluded that while saccharin might be a low to moderate cancer risk, it was not, in its opinion, a sufficient risk to ban its use, The Academy did, however, recommend that children and women of child-bearing age not use saccharin. A subsequent extension of the law for another eighteen months did require that signs be posted in establishments selling saccharin of tile potential risk of saccharin to children and women of child-bearing age. Was "Peer Review" in the saccharin case necessary? Congress thought so. VVhat I have attempted to point out today are three major cases where "Peer Review" of Regulatory Decision Making has occurred not because the Regulatory Agencies planned it that way or because the law said it would be that way, but because the regulatory decision making process had lost
credibility. The public and those being regulated in these cases questioned the validity of the reasoning behind the decisions. And as we have seen in these cases, and the others that could be cited, the doubt and the lack of credibility could have been averted if the decision makers had attained a broad scientific consensus of agreement behind the nature of the hazard and risk posed by the particular substance they were trying to regulate to protect man's health or the environment, What is the solution for avoiding situations such as this for the future? Uppermost. I think we have to recognize that there are two kinds of judgments involved in regulatory decision making. In this regard, the National Academy of Sciences perhaps said it best in its 1977 "'Analytical Studies for the U.S. Environmental Protection Agency. In its first volume of ten studies on EPA's acquisition and use of scientific information used in regulatory decision making commissioned by the Congress, the Academy said these two kinds of judgment are: Fundam. Appl. Toxlcol. (2)
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"Cognitive judgement based on scientific i n f o r m a t i o n and analyses, and Eva/uation Judgment based on policy considerations, "The two are often confused and mixed, reflecting, in part, a failure of communication between the technical and political communities. Cogniti;'c judgmants are subject tu review and validation by the scientific community. Evaluation judgments as to How Best to Achieve the Goals of Policy. or to Set Priorities Among Competing Goals, must always remain in the political arena for final appraisal. "'For example, the identification and assessment of risk to ecosystems or human health are the responsibility of science, but the determination of the acceptability of a risk is a task for the political process, It is often impossible to separate these t~,o kinds of judgment completely, but that is not a reason for failing to try." Again I quote the Academy in its "Analytical Studies for the U.S. Environmental Protection Agency": "But regulatory decision making is hurried by the real or imagined urgency of environmental problems, by public demands for action, and by the resulting statutory deadlines. Congress and EPA are often forced to act before there is sufficient reliable scientific basis for action. "'This rush to regulate is not necessarilywrong: the decision not to regulate is also a decision. If there is no adequate scientific-technical basis for regulation, neither is there an adequate scientific-technical basis for the belief that no regulation is needed. The danger is that, under pressure of adversary interests, the methods of science are bent. and tentative research results may be presented as proven fact. "The Committee on Environmental Decision Making Recommends: 'Scientific and technical data and analyses used in decision making should be reviewed routinely at an early stage to assure that all relevant data are considered and to reduce the possibility of misinterpretation or misuse of scientific results. In this process EPA will be greatly aided by the wide range of scientific and engineering expertise that exists outside the agency. The reviews should be available to the public as a matter of course." As perhaps most of you are aware, I have attempted to formalize the "Peer Review" process in regulatory decision making by legislation. My Bill, H.R, 638, would establish a single National Science Council to decide questions of scientific fact arising in actions by federal regulatory agencies
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charged with overseeing the safety and quality of food, fiber and forest products produced, processed, and marketed by American Agriculture and other related sectors of our country. It also would have jurisdiction over the issue of hazards in the workplace, product hazards, and other related health hazards. The makeup of the Count:it would follow the model already established in EPA's scientific advisory panel, except that it would be 15 in number, selected from 45 nominations submitted by the National Academy of Sciences from specific disciplines such as toxicology and pathology ~ and others firmly based in disciplines capable of determining health hazards in laboratory tests and the population, Once a scientdic question arises in tl,e Regulatory Decis.on Making Process, either party to the issue can refer the case to the Council. The decision of t he Council on the scientific issue or issues is final in that it becomes the official decision of the regulatory agency head. As such, this decision as I0 the scientific issue is treated in a like manner as all other decisions of the agency head in other matters. This Drocedure m no way affects the evaluatton judgment of the Federal Regulator, except that he may find himself in a heap of trouble trying to regulate a hazard which tile Council has decided doesn't exist. I am afraid if he should attempt to do so I~e would find himself a man without a country. The hearings on my bill last June received mixed reviews by and large the Federal Agencies were opposed to a single formahzed system such as my Bill created - - though they all cited they used some type of "'Peer Review" in their decision making. Industry and individual scientists were also mixed in their support. Most of them preferred an advisory capacity for such a Council if it were created and most did not want a full-lime Council as my bill required. The most prevalent view was that we definitely needed a system for each regulatory agency along the lines established in the existing scientific ad~,isorv panel used in the administration of the pesticide law. As for me. I remain strongly behind the proposition that we need a strong, independent peer review system by qualified scientists if w e are to return and maintain reasonableness in our regulatory decision making system. I am of course willing to seek a compromise solution.
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A Proposal to Establish a National Science Council for Peer Review of Decisions Reached by Regulatory Agencies THE HONORABLE WILLIAM C. WAMPLER Member of Congress, U.S. House of Representatives, 2407 Rayburn House Office Building, Washington, DC 20515
Fellow panel members and members and guests of the Society of Toxicology, it is a real honor and pleasure for mo to participate in this symposium. I say that very honestly because the subject we are discussing today has been one of the focal points of my legislative activity. In brief, 1 believe that scientific judgments must be a vital part of our regulatory decision making. Further, I believe that peer review of the effect of those regulations is necessary to insure proper oversight. Congress has a responsibihty not only to pass laws but to oversee whether and how those laws are being carried out. If they are not being carried out or the resulting regulations are not meeting the test of effectiveness, you can be sure that those of us in the Congress hear about it. I can cite several recent regulatory actions by the Executive Branch to ban certain chemicals which caused a rash of communications to the members of the Congress to have these proposals either reconsidered or to change the law which allowed such actions. Cases in point are proposals by the Food and Drug Administration to ban saccharin and nitrites, and a proposal by the Envfronmental Protection Agency to ban the herbicide, 2,4,5-T. Citizens, groups and industries which have taken issue with the actions of the;r government in these case~ want protection of the=r health and the environment and they generally support the goals of these laws. But at the same time, many of them have conceived, rightly or wrongly, that the interpretation of these laws by the executive branch was high-handed, was against their interest, or was not based on reasonable, supportable, or valid evidence. In many cases, scientists themselves were divided as to whether or not there was a risk to humans at all. Or, if there was a risk. to what degree was it a risk? Was it more of a risk to a particular class of persons or was it a risk to all humans? And many scientists were concerned about the methodology and validity of the system used to establish the risk cited. Moreover, different agencies of government had varied ideas as to how to determine risks and, once they were determined, different policies for regulating a specific substance. On top of this confusion, science and technology, itself, confused the w h o l e issue by advancing their own capability to detect the presence of smaller and smaller amounts of a given substance. When the so-called "Delaney Clause" was made a part of the Food. Drug and Cosmetic Act in 1958, technology was only able, I am informed, to determine the presence of a substance w i t h reliability in parts per million. As you are quite aware, this capability has skyrocketed in the last few years to parts per billion and only recently, I have again
been informed, to Darts per trillion. This whole advance in detection has suddenly, at least in my view, created a nightmare. Foods, chemicals, wor'k habits, and even things found in nature thought by most of us to be reasonably safe to human health or the environment, are now suspect based on testing methods now being used to implement the zero tolerance theory brought on by the "Delaney Clause." This advance in technology has had much to do with what I call the "'Delaney Syndrome," and caused some to jest that apple pie, Chevrolet. and even motherhood might be hazardous to healtl~ and the environment if Delaney was applied on a absolute basis. How do peer review and sc=entific decision making fit into this political process? How does the Congress conceive the role of scientific and technical information in environmental decision making? Let me trace for you some of the milestones that have caused me to be particularly concerned with the role of science in regulatory decision making, During the 94th Congress, which held sway during the 1975-76 period, a number of us on the House Committee on Agriculture heard reams of testimony during our oversight hearings or~ the manner in which the Environmental Protection Agency was administering the Federal Insecticide, Fungicide an6,R#denticide ,attt. commonly called FIFRA, or the Pesticide Act. It was charged during these hearings by agricultural interests that EPA was considering the cancellation of numerous already registered pesticides before adequately considering the risk or the benefits of these pesticides to control pests on crops and animals. The argument was not against the right of EPA to cancel a registration, but on the question of h o w EPA arrived at its decisions to announce that they were either going to ban these pesticides or consider banning them. Many thought that EPA was not gefierating, acquiring, end using technical information to the necessary extent to arrive at a proper decision nor at the state that scientific knowledge allowed. Those concerned about the use of science in regulatory decision making were of the opinion that many of these questions were purely scientific in nature. Moreover, others thought that EPA, after considering the scientific question, was not balancing off the risk to human health or the environment against the economic and social questions of the benefits the pesticide might have for protecting our food supply and providing it at a cost that society felt was proper and which all could afford. Those w h o opposed the necessity for peer review and a balancing of risks against benefits were of the. opinion that scientists didn't have all the answers to these scientific ques-
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PEER REVIEW FOR SCIENTIFIC DECISION MAKING tions and that if we must err they wanted to err on the side of human health and the environment. They further argued that EPA had its own scientists who were perfectly capable of making any scientific input that was necessary. A compromise was finally reached and the pesticide law was amended to require the administrator of EPA to submit all actions for proposed cancellations of pesticides to an independent scientific advisory panel for peer review comments as to the impact on health and the environment of such a proposed action. The scientific advisory panel's independence was assured by requiring the administrator to appoint seven members from a list of twelve nominees, six nominated by the National Institutes of Health, and six by the National Science Foundation. Conflicts of interest were resolved by requiring the disclosure of financial, employment and professional affiliation of each nominee. Additionally, the names, addresses and professional affiliations of nominees were published in the Federal Register. So as not to tie the hands of the administrator in emergency suspension cases, grovisions were made to allow the administrator to skip the submission of the scientific and technical data to the scientific panel for comment during emergencies. This exception to the pea.', eview requirement became an issue in the action of the administrator in his emergency suspension nf the Herbicide 2,4.5-T in 1979, when the EPA cited the so-called ALSEA studies as grounds for an emergency suspension of this Herbicide. Since this was an emergency action, the peer review process was bypassed. The ALSEA findings alleged that young women who lived near a forest area in Oregon suffered spontaneous abortions shortly after the forest had been sprayed with 2,4,5-T. The case was also complicated by the allegation that a contaminant, dioxin, associated with Agent Orange, a Vietnam war defoliant, had been found in earlier production runs of 2,4.5-T. It made little difference that the contaminant, dioxin, had been reduced to an insignificant amount in later production runs; those opposed to general pesticide use still branded 2,4,5-T as Agent Orange. The forest industry and independent scientists from numerous walks of life complained publicly that the ALSEA study was flawed as to design, conduct, and statistical interpretation. The scientific advisory panel, in a meeting with me which 1 requested in order to determine if any changes needed to be made to the law, stated that t he 2,4,5-T case showed a flaw in the peer review process. They based their view as a result of their informaT review of the ALSEA data where they concluded that the data appeared to be flawed and at least should have a stiff scientific review. Moreover. the panel said their review could have been accomplished in sufficient time and would not have hindered the proceedings of the administrator of EPA to apply an emergency action. Finally, the panel stated that they should still review the scientific evidence, since the law required the administrator to initiate a full cancellation action, with all its protection to the rights of all parties, once an emergency suspension action had been taken by EPA. However, EPA said the law did not require peer review in this case by the panel because this was an emergency suspension. But when EPA attempted to extend the 2,4,5-T emerFundament,,! and Applied Toxicology
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gency suspension to rice and grazing lands, preparatory to a final cancellation, pressure had budt sufficiently against EPA to send the scientific evidence to the panel for review and comment. The result - - the Scientific Advisory Panel held that there was insufficient scientific evidence to show an impact on health and the environment for the use of 2,4,5.T to control plant pests in the growling of rice and the sustenance of good grazing lands. However, EPA continued its action against 2,4,5-T, but subsequently held that the ALSEA studies were no longer the basis for its action and that other evidence was being used as the basis for the cancellation action. The case is currently before an administrative law judge for a decision on the matter. However, the judge has suspended the hearings and has directed the parties to arrange a compromise on the que,~tion. This compromise effort is still underway and it appears that the end result will be -- not cancellation of 2,4,5-T as originally sought by EPA, but some form of restriction on the manner in which the cllomical is used in forests. In December, t 980, the Pesticide Law was again amended by Congress in a substantial upgrading of EPA's Scientific Advisory Panel Peer Rewew Authority. The amendment re, quired the administrator of EPA by written procedures to provide for peer review of the design, protocols and conduct of all major scientific studies conducted by EPA to regulate under the Pesticide Act. Moreover, the new act required peer review by the Scientific Advisory Panel of the Resul',s of any such action relied upon by the Administrator to classify, suspend, or cancel any pesticide regulated by the Agency. The amendment to the law also permitted the Scientific Advisory Panel to nominate a list of other experts to assist either the panel or EPA in its peer review processes. Further. the amendment recognized the authority of the administrator to act in emergency situations by allowing the agency to bypass temporarily the peer review processes. But the administrator was required to promptly provide thereafter for the conduct of peer review of the action by the scientific advisory panel. To further strengthen the peer review process, the amendment also required the evaluations and the relevant documentations constituting the peer review of the proposed scientific studies and the result of the completed scientific studies to be included in the published comments which the administrator makes in any final regulatory decision under the pesticide act. Was "Peer Review" necessary in the 2.4,5-T case? I think the facts speak for themselves. The other cases which have strengthened the peer review requirement in regulatory decision making are the Nitrite Case and the Saccharin Case. I shall discuss them briefly. In the Nitrite Case, the Food and Drug Administration proposed a ban on the food additive, nitrite, following an announcement of an alleged highly ,~uccessful laboratory study at the Massachusetts Institute of Technology. The study, commissioned by FDA under a Dr. Newberne, involved the long-term feeding of nitrites to rats in an allegedly highly controlled condition. According to FDA's initial announcement, the study showed a significant number of rats had developed cancer to invoke the Delaney Clause. The meat industry also claimed that nitrite prevented botulism during storage and distribution of meat, as 273
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well as giving meats certain tastes and color. A hue and cry also arose against the ban proposal from the public and a number of scientists urging FDA to take a second look at the Newberne Study. Also, a number of members of Congress, responding to these criticisms, demanded that an outsider peer review of the Newberne studies be conducted. I must admit that I was among those members demanding a complete review of the Newbcrne study. My interest was heightened by leaks to me from within FDA itself. These leaks informed me that Dr. Newberne's Lab had flunked an audit of laboratory procedures, that FDA itself had strayed from its own standards and had not conducted its own scientific review of the MIT test (a Library of Congress study), and that Government scientists who had viewed some of the study slides, which Dr. Newberne had alleged showed cancerous cells in the test rats, disagreed with Dr. Newberne's conclusions. This whole affair was compounded when meat scientists throughout the country stated there was no known substitute for nitrite that would prevent botulism. Particularly, the Council on Agricultural Science and Technology (CAST), which reviewed the Newberne study and also did a detailed effects study on alternatives to the use of nitrite that could prevent botulism, announced a position higl~ly supportive of the meat scientists" view. Specifically, CAST felt that there was not an available substitute for nitrite and that additionally, Dr. Newberne's study had a sufficient number of flaws to require a complete review before it could be used as a basis for regulatory decision making, At this stage of the game we were faced with two problems. The first, was the Newberne study sufficiently valid from a scientific basis to show a risk to human health? The second, if Dr. Newber ne's study was valid, would banning nitrites create an additional and perhaps a morP.severe risk, that of botulism? T;" make a short story out of this massive and protracted bureaucratic blunder, and 1believe it was just that, Commissioner Kennedy of FDA announced he was contracting with an outside scientific group, Universities Associated for Research and Education in Pathology (UAREP), to review all the 40,000 slides that Dr. Newberne had collected during his lengthy nitrite study. UAREP's blind study turned thumb's-down on Dr. Newberne°s interpretations of those slides he alleged showed cancer in his test rats. Just recently, The National Academy of Sciences published a report, "'The Health Effects of Nitrate, Nitrite and n-Nitroso Compounds," commissioned in September, 1980 by the Department of Agriculture and the Food and Drug Administration to examine the health effects of dietary nitrate and nitrite and to evaluate possible alternatives to nitrites added to food as a preservative. The first report, completed in December, 1981, dealt only with the risks resulting from natural and added nitrite in food. In accomplishing this task. the Academy was to examine all the scientific literature pertaining to this subject. The second study, on alternative to nitrite, is still underway. The Academy's recommendations state specifically with respect to nitrite: "Evidence does not indicate that n/trite acts ~ directly as a carcinogen in animals." This in effect confirms UAREP's negative evaluation of Newberne's study. However, 274
the Academy goes on to state: "however, because it is a mutagenic in microbial systems end because of its implied role in the induction of esophageal and stomach cancer in humans, further testing in animals may be warranted. If such tests provide any indication of carcinogen/city, then the committee recommends that attempts be made to distinguish between the types of carcinogenic activity, i.e., activity as a complete carcinogen, cocarcinogen, or promoter." While the Academy did not give nitrite an absolutely clean bill of health, it did not recommend its banning, but instead suggested reductions in its use in high quantities; the use of inhibitors or blocking agents, such as ascorbate, to reduce nitrite's ability to form nitrosamines; end further studies and research to find an alternative to nitrite. Was "Peer Review" in the nitrite case necessary? I think the facts speak for themselves. As to my last example of the need for peer review, let's turn to the saccharin case. As a result of scientific tests, which showed carcinogen/city in test animals, saccharin, an artificial sweetener in wide use, was proposed for banning by the Food and Drug Administration. As a national food issue the banning of saccharin was without precedent. The pressure on Congress to halt FDA's proposed action was, to say the least, terrific. A bill was proposed and quickly passed to place an eighteen-month moratorium on FDA, preventing that agency from banning saccharin while the National Academy of Sciences studied the issue. The Academy's study concluded that while saccharin might be a low to moderate cancer risk, it was not, in its opinion, a sufficient risk to ban its use, The Academy did, however, recommend that children and women of child-bearing age not use saccharin. A subsequent extension of the law for another eighteen months did require that signs be posted in establishments selling saccharin of tile potential risk of saccharin to children and women of child-bearing age. Was "Peer Review" in the saccharin case necessary? Congress thought so. VVhat I have attempted to point out today are three major cases where "Peer Review" of Regulatory Decision Making has occurred not because the Regulatory Agencies planned it that way or because the law said it would be that way, but because the regulatory decision making process had lost
credibility. The public and those being regulated in these cases questioned the validity of the reasoning behind the decisions. And as we have seen in these cases, and the others that could be cited, the doubt and the lack of credibility could have been averted if the decision makers had attained a broad scientific consensus of agreement behind the nature of the hazard and risk posed by the particular substance they were trying to regulate to protect man's health or the environment, What is the solution for avoiding situations such as this for the future? Uppermost. I think we have to recognize that there are two kinds of judgments involved in regulatory decision making. In this regard, the National Academy of Sciences perhaps said it best in its 1977 "'Analytical Studies for the U.S. Environmental Protection Agency. In its first volume of ten studies on EPA's acquisition and use of scientific information used in regulatory decision making commissioned by the Congress, the Academy said these two kinds of judgment are: Fundam. Appl. Toxlcol. (2)
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"Cognitive judgement based on scientific i n f o r m a t i o n and analyses, and Eva/uation Judgment based on policy considerations, "The two are often confused and mixed, reflecting, in part, a failure of communication between the technical and political communities. Cogniti;'c judgmants are subject tu review and validation by the scientific community. Evaluation judgments as to How Best to Achieve the Goals of Policy. or to Set Priorities Among Competing Goals, must always remain in the political arena for final appraisal. "'For example, the identification and assessment of risk to ecosystems or human health are the responsibility of science, but the determination of the acceptability of a risk is a task for the political process, It is often impossible to separate these t~,o kinds of judgment completely, but that is not a reason for failing to try." Again I quote the Academy in its "Analytical Studies for the U.S. Environmental Protection Agency": "But regulatory decision making is hurried by the real or imagined urgency of environmental problems, by public demands for action, and by the resulting statutory deadlines. Congress and EPA are often forced to act before there is sufficient reliable scientific basis for action. "'This rush to regulate is not necessarilywrong: the decision not to regulate is also a decision. If there is no adequate scientific-technical basis for regulation, neither is there an adequate scientific-technical basis for the belief that no regulation is needed. The danger is that, under pressure of adversary interests, the methods of science are bent. and tentative research results may be presented as proven fact. "The Committee on Environmental Decision Making Recommends: 'Scientific and technical data and analyses used in decision making should be reviewed routinely at an early stage to assure that all relevant data are considered and to reduce the possibility of misinterpretation or misuse of scientific results. In this process EPA will be greatly aided by the wide range of scientific and engineering expertise that exists outside the agency. The reviews should be available to the public as a matter of course." As perhaps most of you are aware, I have attempted to formalize the "Peer Review" process in regulatory decision making by legislation. My Bill, H.R, 638, would establish a single National Science Council to decide questions of scientific fact arising in actions by federal regulatory agencies
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charged with overseeing the safety and quality of food, fiber and forest products produced, processed, and marketed by American Agriculture and other related sectors of our country. It also would have jurisdiction over the issue of hazards in the workplace, product hazards, and other related health hazards. The makeup of the Count:it would follow the model already established in EPA's scientific advisory panel, except that it would be 15 in number, selected from 45 nominations submitted by the National Academy of Sciences from specific disciplines such as toxicology and pathology ~ and others firmly based in disciplines capable of determining health hazards in laboratory tests and the population, Once a scientdic question arises in tl,e Regulatory Decis.on Making Process, either party to the issue can refer the case to the Council. The decision of t he Council on the scientific issue or issues is final in that it becomes the official decision of the regulatory agency head. As such, this decision as I0 the scientific issue is treated in a like manner as all other decisions of the agency head in other matters. This Drocedure m no way affects the evaluatton judgment of the Federal Regulator, except that he may find himself in a heap of trouble trying to regulate a hazard which tile Council has decided doesn't exist. I am afraid if he should attempt to do so I~e would find himself a man without a country. The hearings on my bill last June received mixed reviews by and large the Federal Agencies were opposed to a single formahzed system such as my Bill created - - though they all cited they used some type of "'Peer Review" in their decision making. Industry and individual scientists were also mixed in their support. Most of them preferred an advisory capacity for such a Council if it were created and most did not want a full-lime Council as my bill required. The most prevalent view was that we definitely needed a system for each regulatory agency along the lines established in the existing scientific ad~,isorv panel used in the administration of the pesticide law. As for me. I remain strongly behind the proposition that we need a strong, independent peer review system by qualified scientists if w e are to return and maintain reasonableness in our regulatory decision making system. I am of course willing to seek a compromise solution.
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