Document O3p2aJMBmyyLG50GqbGwQ1mm1

W"""* Monsanto news JPuA'G* ->yV- ,VOLUME 4 NO. 2 MAY. 1977 MONSANTO COMPANY/CREVE COEUR. MISSOURI 1 I THINKING SENSIBLY ABOUT CONSUMER RISKS AND BENEFITS known to the American cunuimer. Let me explain what I mean in some detail, because our experience may spell valued lessons for your organization--as s k has for mine. The controversial action centers on a i chemical substance known as acrylonitrile, Address by John W. Henley I i Chairman end President Monsanto Company To Executives' Oub Chicago. April 29. 1977 j cases, rats were fed doses of sub stances under examination at rates that are remote from human experience. Not surprisingly, consumers have sharply protested what they see as an unreasonable application of government authority to force accepted products- ination of cranberry shipments in two western states--but most of us recall that consumers all over the country were thoroughly confused at Thanks giving nine. (And the government didn't help much when it proposed sauerkraut as a uanberry substitute!) or "AN" as we call it. This substance has been used in a variety of food-contact applications for more than 50 years and is an ingredient w our plastic bottle. Long before the bottle reached the marketplace, academics, public interest group representatives and outside scien 1 Twenty-fix yean ago. 1 landed at like saccharin and others--from the Then came the ban on cydamates, tific teeing agencies were given exten Midway one night as die first step in marketplace, without due consideration the only other synthetic sweetener be sive data with which to make their own mowing my family from Richfield, Minn., of benefits as well as risks. sides saccharin--an action vigorously evaluation of the environmental conse to Chicago. While I`d been selling soap Had risk-benefit analysis of the. Cycle- debated within Use scientific commu quences of this new' container--the in such far-distant places as Sleepy Safe situation been made by the FDA nity, worldwide, (o this day. plastic from which it was fashioned, its tye, Minnesota, Musselshell. Montana beforehand, it would have revealed that I could go on and on with examples energy consumption, convenience, safe i and Turtle Lake, North Dakota, 1 didn't in the Chicago area, for instance, Mon that seem to haunt the marketplace. ty, recyclability and so forth. 1 picture myself as a small town boy. I didn't stare out of the cab windows santo would be forced to dose down our new Park Forest South bottle-making There was the interlock seat-bell con troversy--a public safety-consumer risk Bottle preferred by consumers at the tall buildings going downtown operation with the consequent loss of question of the first magnitude where During the product's long gestation to the Stevens -- principally because it almost 1,000 jobs here and at other the public loudly and firmly expressed period, we organized a scientific sym was dark! Monsanto locations. hs view. Then there is the synthetic posium which brought together those 1 do remember early in the ride food coloring controversy and questions who opposed as well as those who asking the cabbie, "What's that funny bout aerosol sprays and the oione favored the bottle. At that time we said, smell?" "Money" he replied! (Later 1 layer. And mure--and more--and morel "It is Monsanto's belief that when discovered it was the stockyards.) But industry anticipates any action that can he was right -- it was money! This is Impact of regulatory forces have large scale effects, it is desirable the Big League and I learned a whole lot -- mostly the hard way. f*ve always believed that the tough experiences 1 gained here had a lot to do with the opportunities that later onne to me in corporate life, first at Procter It Gamble and now at Mon santo So 1 retain pieaaant memories ef Chicago and the business com munity that is represented by The Exncvtives' Club. tm Battered lo have been asked to ^eak to this dub and to represent Monnnio before one of die nation's lop leadership groups. The ideas gen J. W. Hanley But 1 want to speak to you today nos as some embattled or embittered manu The net effect is confusion and a growing disruption of creativity and innovation--that typically American fife-giving process which painstakingly brings products from the idea stage to commerciaitzation. The total process involves careful commitments of human and financial resources to develop new products in a fashion this will beat serve consumer needs while providing a real istic return to investors, inventors and `others involved in the cyde. One does not have to look for afield to gauge the impact that regulatory force has had upon the innovation 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 bottle, including possible migration of AN from the wall of the bottle into tne beverage. Following FDA approval of the bottle as a container for carbonated beverages in February 1975, we and Coca-Cob committed considerable resources and effort to the introduction of this wholly :* erated here are studied and talked facturer crying "foul" in defense of process. In the pharmaceutical industry, new packaging concept. Consumer tests about throughout the country. So one approaches your podium with an ap narrow economic interests. Rather. I to use a prominent example, the costs of speak as a concerned citizen who sees a discovering and developing a new ethical quickly demonstrated that the light weight, shatter-resistant plastic bottle propriate respect for this forum's na growing tendency for irrationality to be product have soared eighteenfold, with was overwhelmingly preferred by shop- tional stature. substituted for reason in discusaons of. about half the increment attributable to pen. At the same time, it represented It's in that spirit that 1 selected the and actions relating to. consumer safe FDA regulation. The average number contemporary contributions to those in topic, "Thinking Sensibly About Con ty and acceptable risk. of new drugs approved by FDA declined terested in easier distribution, recycla sumer Risks and Benefits." You might So let's examine some of the more by roughly 70% between the 1957-61 bility and energy savings as compared at first wonder if the nature of Mon serious consequences, including the period and the 1972-75 span. with glass bottles. * santo's business doesn't insulate us from the controversy that today sur long-term effect upon innovation and 1 die these pharmaceutical industry creativity. Then 1 hope to offer a more examples to underline the divergent as Interim tests at variance rounds the issue of risk and benefit realistic perspective against which we well as critical impact this bridle on inno In mid-January of this year, the in the consumer marketplace. We are, can evaluate riak and safety. And, vation has upon American life. Within Manufacturing Chemists Association a after aU, essentially a supplier of inter mediates and raw materials for indus finally, to propose what we at Monsanto believe is a positive contribution to Monsanto's own direct experience, the suspension of our new photic beverage presented FDA with an interim report from an industry-sponsored chronic try and agriculture. enhancing scientific undemanding and container is a vivid example of stifling feeding study of AN. It showed that die eventual resolution of these impor creativity--in ways that are not fully some rats, fed three different levels of FDA action "capricious" tant matters as they affect human Let me assure you that no industry in today's environment can be com pletely isolated from that controversy, least of all the chemical industry. The consumer firestorm ignited by health. At the outset, let me underscore the fact that wc at Monsanto defer to no in dividual or group in our concern for the quality and safety of our products. To Monsanto marketing personnel: In his recent speech before the Executive's Club of Chicago. Mr. Henley outlined Monsanto's commitment to be a leader in demonstrating to 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 There is too much at stake--morally, ethically, financially^o defend unsafe products. But. i contend, the process of safeguarding human health--and. in the public the risks anti benefits of chemical products. This commit ment is an important pert of the corporation's social responsibility objective. bottle. We and Coca-Cola had success fully introduced what we call our Cycle- the specific case 1 cite today, our food supply--can and should be a rational I believe it is appropriate for you to reed his speech in order to gain a greater into the role Monsanto is undertaking in these important Safc* bottle in a number of major one. midwestem and eastern markets--and It began with cranberry* it was going to glory! That regulatory action against us-- Where did it ail begin? The first termed "arbitrary and capricious'' in a signal of an evolving climate may well stay subsequently issued by a Federal have been Use Cranberry Crisis of 1059. f Appeals Court--was based on the same kind of studies that brought about the Remember that? Few of us could recite the specific details of that incident-- matters. Mb ere openly seeking support for our efforts from industry, end your contacts in the marketplace otter an opportunity to reorh this audience. I urge you to use this speech, es you feel eppropriate, as a handout to your accounts and prospects. Bart MacDonald director, corporate marketing coordination threatened saccharin ban. In both which dealt with the suspected contam 22588001 b FG21848 J! ___ ii AN in their drinking water, did develop ghu only in the must minuscule amounu. Fourth, afi of ut aiuri come to under gremt we help finance. Recipients tumors. But to utfrw an amount of AN so FDA ha* quite properly feh there wai stand that these decisions cannot be funds will be able to pursue witate equtvMeot to even the lowest level fed to no problem to be concerned about. reached by scientist battling scientist careers may interest them most--m cov the test animats, a child would have to What hat happened, in part, b that over interpretations of test data--even emment. academia or industry, drink more than 3,000 quarts of bev. our ability to measure and interpret the within the concept of a Science Court need is equally critical in all areas engc every day Cur one year from Cycle* effect these substances have on human which would permit a formalized forum The grants will go to those univer Safe bottles. health has outstripped die laws that re for scientific debate, and which I think sities that arr alreadv doing a commend We pointed out to the FDA that we gulate their use. has merit. Ultimately, these are public able job in the field of toxicology, and were concerned by the findings--but It was two decades ago that the so- decisions which should be mode after have demonstrated the rapacity of dumg that they were preliminary and incon- called Delaney Amendment to the Food, delilierative consideration of benefit still better. cluivc...diat they were at variance with Drug and Cosmetic Act bc^ine law-- versus risk. Importantly, the consumer This grant program is designed to en other tests on acrylonitrile...and that the clause which prohibits the use of must be heard in this process. courage other companies to contribute Monsanto would immediately begin with chemicals in foods if cancer an be in further AN feeding studies at levels that would provide more realistic evaluation. duced in lest animals at any feeding level no matter how massive. At the time, our How much IS a "part per million" or a "part per billion'??? Our plans drew a favorable response scientific understanding of trace quan These calculations may surprise you. from die FDA tities and their effect ujxjji human health But a month later, the agency an nounced its intention to suspend approv al of carbonated beverage bottles made was. by today's standards, unsophisticated. In the intervening years, we have introduced such tools and methods of 1 pert per million f tppmt 1 part per billion ( t ppe i from AN. Ironically, the same week that the detection as the election microscope, mass spectroscopy and neutron activa LENGTH f inch par t mUes t inch par 16,000 miles FDA acted on our bottle, the Canadian government approved acrylonitrile for tion analysis which can pinpoint trace quantities as small as one part per trillion. TIME 1 minute par 2 years 1 second per 32 years use in plastic soft drink containers. Bui where innovation has suffered a double blow in this instance is that That's one bad apple in two billion barrels of apples- VOLUME 1 drop vermouth par SO fifths ofgin 1 drop vermouth per 500 barrels ofpin Monsanto and Coca-Cola were poised to introduce a refdlablr plastic beverage Needed... a more balanced effort AREA l sq. foot par 23 acres 1 sq. foot per 36 sq. miles container--a bottle that both the FDA and FTA had said publicly was the moat Our nation's scientific genius has be ACTION fixity par 3JSOO 1 bogey per 3,500.000 environmentally desirable method of come, in effect, a double-edged sword, golf tournaments golf tournaments packaging soft drinks yet conceived-- just as we now have the technology to perhaps as a meaningful answer to some of our nation's litter problems. Obvi identify infinitesimal trace quantities, we also know infinitely more about how hu QUALITY 1 bad apple per 2,000 barrets 1 bad apple per 2,000,000 barrels ously, we cannot move ahead with this man systems cope with toxic substances. unique answer to the "throwaway" ques tion now that the fate of the container But the issue becomes magnified and beclouded when we lose perspective on And finally, industry and government, in like manner. Indeed, so great art the public interest groups and the scientific dimensions of the program that onl^ a business has been jeopardized by the FDA order. It is at junctures such as these that all of us--consumers and concerned citi zens--must ask if reason and common sense are being brought to bear on decisions chat not only concern human safety but also affect jobs and the commitment of vast resources. To challenge, as I most certainly do, die advisability of product bans based on 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 tacts so justify. 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 rats--rats that had been fed the synthetic sweetener in amounts that would exceed a consumer drinking 800 tteetvcaunce diet sodas dastf for a lifetime. Is that a "risk" worth taking? 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 derision-making. In effect, it says that community, must lay before the Amer ican people all the evidence, relating to questions of product safety and human health, in an open and forthright manner. $500,000 grant to train toxicologists It is to advance such sbentifle fact finding that Monsanto has just approved a half-million dollar grant to increase our nation's understanding of the effect our products have upon human health. We intend to do this by supporting ot the graduate and post-doctoral levels the naming of tamcolagists-those specialiats who deni with ike origin, nature and propsrtitj of harmful materials. broadly-based effort can cope with it successfully. 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 have characterized the debate ove-r the pr per interest of industry, govern-- and the consumer. 1 believe Monsanto has demons and is demonstrating forcefully with its program of support for education, that the question of consumer nsk can be 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 if any risk of cancer can be demon- We are, of course, fully aware that many of the questions and resolve many What is safe??? rated, then thot is that. There is no room for weighing the benefits," the toxicologists, by themselves, will not of the doubts that currendy cloud our solve all the problems I have alluded to ability to find a reasonable approach to It is appropriate then, to raise the questions, "What b safer and "How great b the risk?" Not for a moment would I suggest that these are simple questions. Or that thou who may disagree with our view point are motivated by malice or ig norance. These are enormously complex issues on which men of good sense and Times went on. "against its costs. Yet such cost-benefit analysis is basic to any sensible judgment." The Times concluded by stating that the Delaney dausc "has long needed re placement by a more balanced effort to protea the public against carcinogens." With this, most reasonable citizens would agree. today. This will cake bkxhemists and specialists in a wide range of disciplines. But toxicologists can be an important factor in accumulating data that will be helpful in judging risks and benefits. With society's ever-increasing atten tion to questions of human safety, as well as the passage of the industry-supported Toxic Substances Act. our nation is faced with a critical shortage of quali the issue of acceptable consumer risks and benefits. -- good will can, and often do, differ. But fied personnel to carry out the careful what is musing from the current dia logue, in my judgement, b a rational Needed... a clearer perspective scientific studies associated with toxic substances and human health and safety. perspective on consumer risk. So what can the public, business and To cite a few examples that point up Just to illustrate--and not to make government do to bring a more clear- the critical nature of the situation: ! light of concerns for toxins in our food minded perspective to this growing The latest annual report of the \ supply--scientists tell us that four pounds of raw cauliflower, eaten at one national debate? I suggest these five steps: Society of Toxicology placement bureau shows that in 1974. roughly 4 sitting, contain enough toxins to pro First, the Delancv Amendment must half of the advertised openings for duce serious, if not fatal, effects in hu be reconsidered and updated in light of toxicologists Mere filled. In 1976. mans. Doesn't ii seem as unreasonable modern technolop and our under only one-fourth of the openings to assume that anyone is going to di ink standing uf the ef fect truce quantities of were filled. The entire Satiety of thousands ot quarts of a beverage every chemicals and other substances have Toxicology, incidentally, includes day for a year as it is to assume that and do not have on human health. only 850 members--about half the anyone will cat four pounds of raw cali- Second, we must pul an end to re enrollment of societies in coiner- flower at one sitting? gulatory policy established in an ad hoc able disciplines. fashion--whereby the conditions of In some special areas of toxicology, \ The Delaney Amendment acceptability literally change overnight without full debate among the parties the disparity between supply and demand is even more acute. An Even when a toxic chemical does mi directly aflrcird. other professional placement ser \ grate from a container to the contents, Third, risk-benefit analysis must be vice recently listed 100 openings 4 it doesn't necessarily mean tli.it a human brought to the decision-making process. for inhalation toxicologists--with i health hazard exrus. Fine covial glass The costs ihi oughoiit industry of the no applicants at all. 4 ware, which hjs been used salrly for centuries, is shout one-thiid lead. Lead punitive measures I've dcstrilied range Through Monsanto's philanthropic into the hundreds of millions of dollars. foundation--the Monsanto Fund--grants 1 has been found to cause carnet in ani In human terms--jobs and rronomic will be made to selected untvrtsitics on mats arid, in excessive .amounts, as toxic dulxalion--the mill are often an mtresti i< tctl basis. We will have no to humans as welt But it ungrate* front immeasurable vested interest in guduates of the pr<*- B FG 21849 FROM SUBJECT CPSC Members Marie Schmiederer FIELD POINT OR DEPT. & BLDG. NO. j FIELD POINT OR DEPT. & BLDG NO. i________________ D/5428 Consumer Product Safety Committee April 29, 1977 I DATc YOUR LETTER I DATE'THIS LETTER 5/3/77 Present: R. B. Downey F. E. Krause J. F. Malone J. P. Morrill R. D. Savage Absent: D. L. Kent 1. Toxicity: a. John Morrill reviewed the Acrylonitrile (AN) situation. The Louisville plant is planning to install a new Hycar extruder line by January, 1978. In order to do this, the amount of acrylonitrile emitted to the air must be reported to the Jefferson County Air Pollution Control Board in an Environmental Impact Statement. The amount of AN in the atmos phere is not known at the present time. However, the Hycar recovery system is achieving only 60% hydrocarbon recovery, instead of the 85% target. The long term solution is a new recovery system which will probably cost $2.5 - 5 million and require two years to install. Ed DeCapita's results on residual AN are higher than previous levels. Results include 15ppm for 2301 x 36, 2 ppm for 2600 x 120 (after stripping), and 82 ppm for Cosden margarine tub compound. John v Whitney is trying to adapt the head space method for plant use. Personal monitoring results show 95% of the readings are below 20 ppm. However, results at Akron are still high. b. Marie Schmiederer indicated that BFG comments to EPA on inventory and reporting requirements of TOSCA were being coordinated through Ernie Bean. Ben Zwicker has obtained a tentative list of the 50 chemical substances designated for further toxicological study. Dick Savage indicated concern for the definition of test marketing vs. phase development. The group felt that further input from Ernie Bean was necessary. c. Dick Savage reported that the carcinogen ban has been dropped from the New Jersey Skevin bill. Action on the bill has been delayed for 6-8 weeks. We will prepare to testify at Committee hearings in June. more BFG2A850 T0068G2 Page 2 d. Jerry Cohan reported on the meeting sponsored by the SPI Toxicity Subgroup on TOSCA. Most SPI members present favored limits of up to 5% difference before considering polymer A different from polymer B. This would allow for minor changes in monomer curatives and other functional compounding monomers. Jerry felt that more specific examples to support our position would be required. (This is one of the BFG comments -- that will be further evaluated and discussed with Ernie Bean.) SPI has compiled a hazard ranking, relative to toxicity that could be used for screening. There are strong rumors that the TOSCA Administrator . will be a political appointee. e. Dick Savage reported that an emergency benzene standard, similar to the 1 ppm vinyl chloride standard, had been announced. f. Bob Downey indicated that Keller & Heckman had authored a bill that addressed the question of what constitutes a food additive, in light of a risk-benefit analysis. Combustibility: 2. Bob Downey summarized PR efforts for meeting the expected challenge of PVC conduit at the NFPA meeting, the week of May 15. Key 160 organiza tion members will receive a letter this week that presents the advantages of PVC, as well as the third parly report of NEMA/UL. An actual rebuttal . of the anti-PVC Factory Mutual report will be used at the NFPA meeting. Next meeting -- Friday, May 13 at 11:00 a.m. in Conference Room 1 C. ^y}[alu' Marie Schmiederer MS/tp --- 22589002 BFG21851