Document g28Vgk1mY3GgGe2joKxEgYvY9

Oi'. .`r-rzskjxisc: *t&*s*ibe> .-. 1^*4- c?b*i>u-v Et^: 'V.-,-. TTjic:.. r '. ' VOLUME 4, NO. 2 MAY. 1977 ~a?r3T,rc.!*r': MONSANTO COMPANY/CREVE COEUR. MISSOURI THINKING SENSIBLY ABOUT known to the American commiicr. Let me explain wli.it ( mean in some CONSUMER RISKS AND BENEFITS detail, because our expo icuce may spell valued lessons for your org.mi/jtjtin--as U has for mine. The controversial action center* on a dtcmicaJ sulwlancc known .i> acrvlonuriic. Address by John W. Henley Chairman and President Monsanto Company To Executives' Club Chicago, April 29, 1977 Twenty-six years ago, I landed at Midway one night as the first step in moving niv family from Richfield, Minn., to (ihic.tgo. While I'd been celling soap in such far-distant places as Sleepy Eye, Minnesota, Musselshell, Montana and Turtle Lake. North Dakota, I didn't picture myself as a small town boy. 1 didn't sure out of the cab windows at the tall buildings going downtown to the Stevens -- principally because it was dark! I do remember eariy in the ride asking die cabbie. "What's that funny smell?'* "Money** he replied! (later I discovered it was the stockyards.) But he was right -- it was money! This is the Big League and l learned a whole lot --- mostly the hard way. l*ve always believed that the tough experiences 1 gained here had a lot to do with the opportunities that later came to oe in corporate life, first at Procter L Gamble and now at Mon santo. So I retain pleasant memories of Chicago and the business com munity that is represented by The Executives* Club. I'm flattered to have been asked to speak to this dub and to represent Monsanto before one of the nation's top leadership groups. The ideas gen erated here are studied and talked about throughout the country. So one approaches your podium with an ap propriate respect for this forum's na tional stature. It's in that spirit that t iActed the topic* "Thinking Sensibly About Con sumer Risks and Benefit*." You might at first wonder if the nature of Mon santo's business doesn't insulate us from the controversy that today sur rounds the issue of risk and benefit in the consumer marketplace We are. after all. essentially a supplier of inter mediates and raw materials for indus try and agriculture. cases, rats were fed doses of sub stances under examination at rates that arc remote from human cxjtcriciK e. Not surprisingly, consumers have sharply protested what they sec as an unreasonable application of government authority func accepted products-- like saccharin and othcis--from the marketplace, without due consideration of benefit- as ill as risks. Had ri-k-bincfit analysis of the. CycleSafe situation fccn made by the FDA beforehand, it would have revealed that in the Chicago area, for instance, Mon santo would be forced to close down our new Park Forest South bottle-making operation with the consequent loss of almost 1,000 jobs here and at other Monsanro locations- J. W. Hanley But l want to speak to you today not as some embattled or embittered manu facturer crying "foul" in defense of narrow economic interests. Rather, I speak as a concerned citizen who sees a growing tendency for irrationality to be wH"**1 for reason in diecusrions of, and actions relating to. consumer safe ty and acceptable risk. So let's examine some of the more serious consequences, including the loof-tena effect upon innovation and creativity. Then I hope to offer a more realistic perspective against which we can evaluate risk and safety. And, finally, to propose what we at Monsanto believe it a positive contribution to enhancing scientific understanding and ination of cranberry shipments in two western states--but most of us recall that consumers all o\er the country were thoroughly confused at Thanks giving time. (And the government didn't help much when it pioposed sauerkraut as a etanbeny substitute!) Then came the ban on cyclamates, the only other synthetic sweetener be sides saccharin--an ac'ion vigorously debated within the scientific commu nity. worldwide, to this day. 1 could go on and on with examples that seem to haunt the marketplace. There was the interlock seat-belt con troversy--a public safety-consumer risk question of the first magnitude where the public loudly and firmly expressed its view. Then there is the synthetic food coloring controversy and questions about aerosol sprays and the ozone layer. And more--and more--and more! Impact of regulatory forces The net effect is confusion and a growing disruption of creativity and innovation--that typically American life-giving process which painstakingly brings products from the idea stage to commercialization. The total process involves careful commitments of human and financial resources to develop new products in a fashion that will best serve consumer needs while providing a real istic return to investors, inventors and others involved in die cyde. One does not have to look far afield to gauge the impact that regulatory force has had upon the innovation process. In the pharmaceutical industry, to use a prominent example, the corns of discovering and developing a new ethical product have soared eighteenfold, with about half the increment attributable to FDA regulation. The average number of new drop approved by FDA dediaed by roughly 70% between the 1957-61 period and the 1979-75 span. 1 die these pharmaceutical industry examples to underline the divergem as well as critical impact this bridle on im vxtion hat upon American life. Within Monsanto's own direct experience, the suspension of our new plastic btmigt container is a vivid example of stifEng or "AN" as we call it. This substance has been used in a variety of food-contact applications for moic than M) years and is an ingredient in our plauii hotde. Long before the boule reached the marketplace, academics, publk mtetest group representative* and outside Micntilic testing agencies were given exten sive data with whicl) to make iheir own evaluation of the cnviiomnenial conse quences of this new cuntainei--the plastic from which it was fashioned, its energy consumption, convenience, safe ty. recyclability and so forth. Bottle preferred by consumers During the product's long gestation period, we organized a scientific sym posium which brought together those who opposed as well as those who favored the bottle. At that time we said, "It is Monsanto's belief that when industry anticipates any anion that can have Urge scale effects, it is desirable that the scientific basis for this action should be subjected to scientific peer review and criticism." And so it was. These experts, and others inside and outside government, concluded that Monsanto had carefully tested and was continuing to test all the impacts of the buttle, including possible migration of AN from :he wall of the bottle into the beverage. Following FDA approval of the boede as a container for carbonated beverages in February 1975, we and Coca-Cola committed considerable resources and effort to the introduction of this wholly new packaging concept. Consumer tests quickly demonstrated that the light weight, shatter-resistant plastic bottic was overwhelmingly preferred by shop pers. At the same time, it represented contemporary contributions to those intereued in easier distribution, recycla bility and energy savings as compared with glass bottles. Interim tests at variance In mid-January of this year, the Manufacturing Chemists Association presented FDA with an interim report from an industry-sponsored chronic feeding study of AN. It showed that FDA action "capricious" the eventual resolution of these impor creativity--in ways that are not fully tant matters as they afreet human some rats, fed three different levels of Let me assure you chat no industry in today's environment can be com pletely isolated from that controversy, lean of all the chemical industry. The consumer firestorm ignited by the proposed ban on saccharin by the Food and Drug Administration followed by only a few days the suspension of Monsanto's innovative plastic beverage bottle. We and Coca-Cola had success fully introduced what we call our CycleSafe* bottle in a number of major health. At the outset, let me underscore the fact that we at Monsanto defer to no in dividual or group in our concern for the quality and safety of our products. There is too much at stake--morally, ethically, financially---to defend unsafe products. But. I contend, the process of safeguarding human health--and, in the specific case I cite today, our food supply--can and should be a rational one. To Monsanto marketing personnel: In hie recant speech before tine Executive's Club of Chicago. Mr. Hanley outlinedMonsanto'S commitment to dee feeder in demonstrating to dte public the risks end benefits ofchemical products. This commit ment is en importantpart of the corporation's social responsibility obieethm. KN<7 C> / bottom it is appropriate for you to reed his speech in order to gsin e greeter insight into dte roie Monsanto is undertaking in these important midwestern and eastern markets--and it was going to glory! That regulatory action against us-- termed "arbitrary and opritMus" in a It began with cranberrys Where did it all begin? The first signal of an evolving climate may well te are openly seeking support for our efforts from industry, and your contacts in the marketplace offer an opportunity to reach this audianca. / urge you to use this speech, as you feel appropriate, as e handout to F* 1 stay subsequently issued by a Federal Appeals Court--was tusert on the same kind of studies that brought about the threatened saccharin ban. In both have been the Cranberry Crisis of 1950. Remember that? Few of us could recite the specific details of that incident-- which dealt with the suspected contam your accounts and prospects. Bart MacDonald director, corporate marketing coordination BFG22199 ! AN in their drinking water. did develop tumor*. Bui to ingest ait amount of AN equivalent to even the kmevt level fed to the test animals, a chikt would have to drink more than 3.000 quarts of bev erage every day for one year from CycleSafe bottles. We pointed out to the FDA that we were comer nrd !>y tin* findings--but tltAt they were preliminary jrul momc!tis:\e thi'.t they were at v.iruiiic with ether tests on acryUnnirili- .and that Monsanto mould iitunctii.iU'iv begin with further AN feeding studies at levels that would provide more realistic evaluation. Our plans drew a favorable response from thr FDA. But a month litter, the agency an nounced its intention to sus{>cnd approv al of carbonated beverage bottles made from AN. Ironically, the same week that the FDA acted on our bottle, the Canadian government approved acrylonitrile for use in plastic soli ritink containers. But where innovation has suffered a double blow in this instance is that Monsanto and Coca-Cola wore poried to introduce a refutable plastic beverage container--a bottle that both the FDA and UPA had said publicly was the most environmentally desirable method of packaging soft drinks yet conceived-- perhaps as a meaningful answer to some of our nation's Uucr problems. Obvi ously, we cannot move ahead with this unique answer to the "throwaway" ques tion now that the fate of the container business has been jeopardized by the FDA order. h is at juncture* such as these that all of us--consumers and concerned ettitens--must ask if reason and common sense are being brought to bear on decisions that not only concern human safety but also affect jobs and die commitment of vast resources. To challenge, at I matt certainly do, the advisability of product bans based oo evidence that is subject to widely different interpretation within the scien tific community, is not to challenge the government's right and obligation to protect and safeguard public health where facts so justify. Whatisnfc??? It is appropriate then, to rafee the questions, "What is safe?* aod "Most great is the risk?* Not for a moment would t suggest that these arc simple questions. Or that those who may disagree with our view point are motivated by matter or ig norance. Them are enormously complex issues oo which an of good sense and good witt can, and often do, differ. But what is missing feom the current dia logue, in my judgement, is a rational perspective on consumer risk. Just to ilhisrrast end not to make light of concerns far toxins in our food supply--scientists tell us that four, pounds of raw cauliflower, eaten at one sittutg. contain enough toxins so pro duce serious, if not fetal, effects in hu mans. Doesn't it seem as unreasonable to assume that anyone b going to drink thousand* of quarts of a bev erage every day far a year as it b to asMtme that anyone will eat four pounds of raw cattflower si one sitting? The Delaney Amendment Even when a toxic chemical does mi grate from a container d> the contents, it doesn't necessarily mean that a human health hazard exists. Fine crystal glass ware. which has been used safely for centuries, is about one-third lead. lead has been found to cause cancer in ani mals and, in excessive amounts, is toxic to humans as well. But it migrates from glass only in the mm minuscule amounts, so FDA has quite properly felt there was no problem 10 be concerned almut. Wh.il has happened, ui part, is dial our ability to measure and interpret the effect these substances have on human health has outstripped (he laws that re gulate then use. Ii Mas two decades ago that the socalled Delaney Amendment to tlic Food. l)i ug jml Cosmetic Act became law-- the clause winch prohibits the use of cht-iimaU in (nods if cancer can be in duced in test animals at any (ceding level no mailer how massive. At thr lime, our scientific imdeiwjmlmg of U.ictr quan tities and their effect ujion human health was, by today's standards, unsophisticated. In the intervening years, we have introduced Mich tools and methods of detection as the electron microscope, mass spectroscopy and ncunon activa tion analysis which can pinpoint trace quantities as small as on* part per trillion. That's one bad apple in two billion barrels of apples. Needed... a more balanced effort Our nation's scientific genius has be come. in effect, a double-edged sword. Just a> we now have the technology to identify infinitesimal trace quantities, we also know infinitely more about how hu man systems cope with toxic substances. But the issue becomes magnified and beclouded when we lose perspective on what these quantities mean when trans lated into human terms. For instance, the rationale for the recent ban on saccharin, as in the case of the plastic bottle, was the discovery of tumors in rat^~raca that had been fed the synthetic sweetener in amounts that would exceed a consumer drinking 800 tkoivt-outtcr diet sodas dadj for a lifetime. Is that a "risk" worth caking? 1 sug gest that a fully informed American people should, at the very least, have a right to choose. In the words of a New York Times editorial which recently called for replacement of the Delaney Amendment. "The unqualified nature of the Delaney clause prohibits rational decision-making. In effect, it ays that if any risk of cancer can be demon strated, then Mat is (Bat There is no room for weighing the benefits," the Times went on. "against its casts. Yet such cost-benefit analyns is baric to any sensible judgment.'* The Times concluded by stating that the Delaney dause "has long needed re placement by a more balanced effort to protect the public against carcinogens.* With this, most reasonable citizens would agree. Needed... a cleerer perspective So what can the public, business and government do to bring a more dearminded perspective to this growing national debate? I suggest these five steps; First, the Delaney Amendment must be reconsidered and updated in light of modern technology and our under standing of (he effect trace quantifies of chemicals and ocher substances have and do not have on human health. Second, we must pul an end to re gulatory policy established in an ad hoc fashion--whereby the conditions of acceptability literally change overnight without full debate among the parties directly affected. Third, risk-benefit analysis must be brought to the decision-making process. The costs throughout industry of the punitive measures I've described range into the hundreds of millkm* of dollars. In Imman terms--jobs and economic dislocation--the costs arc often immeasurable. Fourth, afl of us mutt come to under stand that these decisions raimirt be reached by scientist battling scientist over interpretation* of test data--even within (he concept of a Science (anirt which would permit a formalized forum for scientific deflate, and which I think has merit Ultimately, these .nc pultlic decisions which slumld be nude alter dclihcraii'e consideration of benefit versus risk. Importantly, the consumer must be laai cl in this process. grams we help finance. Recipients of fundi will be able to pursue sluincr careers may mteictt them most--in gov* ernment. academia or industry. 1 he need is etpially critical in all arras. The grants will go to dune ur sines that arc already doing a conrnu. able job in the field n! tuxitology, jimI have demonstrated the capacity u( doing still better. 1 ' gi ant program is designed to vn- coinage otlici companies to contribute How much IS a "part per million" or a "part per billion"??? These calculations may surprise you. LENGTH 1 part per million ( i ppm l 1 inch per 16 miles ^ part per billion l tOO* 1 1 inch per 16,000 miles TIME 1 minute per 2 years 1 second per 32 years VOLUME AREA 1 drop vermouth per 80 fifths of gin 1 sq. foot per 23 acres 1 drop vermouth per 500 barrels of gin J sq. foot per 36 sq. miles ACTION 1 bogey per 3.500 golf tournaments 1 bogey per 3.500,000 golf tournaments QUALITY 1 bad apple per 2,000 barrets 1 bad apple per 2,000.000 barrels And finally, industry and government, public interest groups and the scientific community, roust lay before the Amer ican people sff the evidence, relating to questions of product safety and human health, in an open and fouhright manner. $500,000 grant to train toxicologists It is to advance such scientific fact finding the Monsanto has just approved a hatf-miHion dollar gram to increase our nation's understanding of the effect our products have upon human health. We intend to do this bp supporting ot the jiarfutti and post doctoral leveli the teaming of toMCologuO-thev tpeemtub who deal with the ongtn, nature and peoperties of harmful materials. We are. of course, faOy aware that toxicologists, by themselves, will noc solve all the problems I have alluded to today. This will take biochemist* and periattsu in a wide range of disciplines. But toaucologisu can be an important factor in accumulating data that trill be helpful m judging risks and benefits. With society's ever-incrcasing atten tion to questions of human safety, as weB as the passage of the industry-sup ported Toadc Substances Act, our nation is faced with s critical shortage of quali fied personnel to carry out the careful irwarifir studies associared with toxic substances and human health and safety. To cite a few examples that point up the critical nature of the situation: o The btest annual report of the Society of Toxicology placement bureau show* that in 1974, roughly half of the advertised openings for toxkologistt were filled. In 1976. only one-fourth of the openings were filled. The entire Society of Toxicology, inddcncalty, indudes only 850 members about half the enrollment of societies in compar able disciplines. o In some special areas of toxicology, the disparity between supply and demand is even more acute. An other professional placement ser vice recently listed 100 openings for inhalation toxicokigisti--with no applicants at afl. Through Monsanto's philanthrope foundation--thr Monsanto f und--grants wilt be made to selected universities on an unrestricted basis. We will have no vrsird interest in graduates of the pro in like manner. Indeed, so great are die dimensions of the program that only a broadly-based effort can cope with it succenfully. As this effort moves forward, we must confront the question of consumer risk in a manner free from the old suspicion and irrationality that too often hate characterized the debate over the pro per interest of industry, government and the consumer. I believe Monsanto has demonstr**.,l and is demonstrating forcefully * program of support for educapoi the question of consumer risk can uc addressed in a responsible and construc tive fashion. I hope government, the public interest groups and the citizenry will join us in this same spirit so that we can answer many of the questions and resolve many of die doubts that currently cloud our ability to find a reasonable approach to the issue of acceptable consumer risks and benefits. BFG22200 iBIFGoodrich hi Mill 22635001 At 0 fat. ____________ A fa '/7/?7 ; BFG22201 BFG-II29-B 1/77 !44kJ /$ *-' ________________-A-^7_______________ ______________ dL/&t.cHu**, k/ed%U/> MJLz. 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