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107



.

How a major
chemical company manages.
the risks and bene?ts in
technological progress

Monsanto?s
early warning
. i system

Inlterviewed by .4
1 David W. Ewing and 5 
Millicent R. Kindle . ?1

John W. Henley

3,4
lr fr}
i . o, 

 

Few potential conflicts

Perhaps no one at Mon-

Following the interview

The four inter?ews were

henveen business and so-f santo supports such efforts with Mr. Henley are short conducted by David 
ciety have created so muCh more vigorously than does interviews wit three Ewing. managing editor
public concern as the risks its chairman and?chief Monsanto executives who of HBR, and Millicent R.

inherent in scientific and
technological advance.
One leading corporation I
that has sought to reduce
this area of conflict is
Monsanto. At various
stages in the development
Of a new material or chem-
ical product, it brings to-
gether knowledgeable sci-
entists and engineers to 1
"blow the whistle" on a'
new product concept that
may introduce unaccept-
able hazards to users.
Monsanto has organized
task forces to analyze the
role and effects of so-
called "devil's chemicals"
-that is, product and pro-
cess chemicals that may
cause cancer. Moreoverj
with scienti?c advances
taking place every day,E
the company seeks to de-
velop a realistic, up-to-T
date philosophy about the
trade- offs between risks
and bene?ts in technical
progress.

executive officer, lohn W.
i-lanley, the subiecr of the
main interview in tl?s
article. Formerly execu-
tive vice president at
Procter eJ Gamble,

Mr. Henley came to.Mon-
santo as chief executive in
1972. He is also a director
of Citicorp and May De-
partment Stores, in addi-
ti0n to serving on various
government boards con-
cerned with foreign 
trade.

arc?intimately involved
with efforts to assess the
potential hnzards in new
and existing products.
Curtis Elmer manager of_
cnvir mental staff 1n-
form'a' describes a
massiv ongoing project
to collect late on the im-
pact iernicals on the
health {the company?s
45,00 .doniestic and

  
 
 

20.000 overseas employees.

Dexter Shrirp, director of
environmental sciences
research for- agricultural
products discusses efforts
to assess possible carcino-i
genie and other toxic ef?
fects of herbicides. And.
Dr. Roger Eolk. director
of the environmental
health laboiratories, dis- 

cusses his g?ro'up' philos- .
ephy and approach in_ test-

ing the effects of the com-
pany '5 products on health
and the environment

I



Kindle, manuscript editor.

Photographs courtesy of
Monsanto Company. .

 

 

. il
1

 




 
 

 
  





..

  
   
    
 
 

he 

rather, I regard it as ite appropriate. The facts are
I that Americans don? have a very good perception

operators?complete with leaky valves and drip-

can?t afford to have a safe process or a safe place to

  
   
    
 
   
 
 

. development, especially the potential hazards to

  
   
   
   
   
 
     
 
   

 
     

 
 

Interview with
john W. Hanley

HER: What does it feel like to be

chief executive of a giant chemical company dur-
ing a period when the word "chemic?al" haS'come
to mean ?cancer maybe" in the minds of much of

 

    
 
 
     
 
 
       
 
   
     
   
    
 
         
 
       
 
   
   
   
    
 
   
    
 
   
 
 

Mr. Hanley: I don sense any appre-
ciable difference in my role from that of other
chief executive officers of reasonably complex com-
pari es. BCCause Monsanto and the entire chemical'
ind stry are in the public we re perhaps more
sensitive to certain societal issues th.11 orne of my
counterparts. But I dog?t see thatps proddctive,

of the risks and the benefits of chemicals.

Our whole society is moving to ad-
dress itself to a range of problems and Opportunities,
and the chemical industry has perhaps a dispropof?
of those Opportunities at the moment
but doesn b0ther me. I think we recogmze an
Obligao to help educate the public which is the 
solution t01 the problem. 

n: so": 

i It must be hard to counter the pop-
ular' impression of chemical companies as risky
places to work.

The trouble is, there are a few schlock

ping pipes?on the economic margins of the in-
dustry. or wrongly, they believe that they

work. But for the vast majority of the industry,
that's a'serio'u'sl'y distorted perception.

Many observers believe that
Monsanto has developed an effective approach to
anticipating and handling the risks of new product

health and the environment. How does this work?
I 1 

We try to climinatefall of the pos-
sible surprises, and that?s easier to do with new than
existing projects. At every major stage of research
and development wb formally assess the possible
hazards of a new material or process. We look at
things like the-known or expected impurities of-a
new product, its expected toxicity (what technical
people call "acutef? and ?chronic? toxicity), fore-
seeable dangers in disposal, and the ability of cus?-

 



. .
tomers to use the material properly and safely. So

these are our preliminary assessments of the hazards 

?any effects on the health of workers, users, the 
public at large, the natural environment, the chain
of life. I .

If the new product passes these early
tests and goes into development, we hold tech-
nology risk reviews. This means that we bring
together the most people we can
?nd?doctors, industrial hygienists, chemists, biol-.
o'gists, safetyexperts, epidemiologists, animal .toxi.
cologists, and anyone 'else who is technically quali-.
?ed to see how, where, and when that material or
process might cause tiouble. What might go wrong?
What exposure levels Emight cause what risks?

If the experts see potential hazards, .
the question becomes', ?Can those dangers be
managed?? For example, can we change the pro- .
duction methods to recycle the hazardous dust? Can
we eliminate the risk {by a special valve or some .
other safeguard? If the answer is yes, we go ahead,
assuming that the prdject makes economic sense; 
if it is no, then we sto?p work on the project.

Do these eXperts?the ?early whistle-
blowers??come from your own staff? 

Many ?df them do, but not all. It de-
pends. We don?t claim to be the fountain of all ?i 
knowledge, and so we contact experts outside the
company universities and other organizations in 
the United States?in organizations all over the
world, in fact. For instance, we may have a product
that raises a questionf about the effect of zinc in the
metabolic system. We don?t have experts here on .

zinc metabolism, but we know where they are and

. we call on them Dr. Bert Vallee at the Harvard
Medical School is one. So we would ask him to 
come in and help us assess the risk with a zinc 
metabolite. 

What happens if the experts dbn't
agree? - . 
Then we are forced to take the most
conservative posture possible. If the product would
pose substantial risk in the judgment?of one or 
more of the best quali?ed experts, we can?t take a
chance on it.? If there is uncertainty, we?ll go out
and try to get more data on" the questions raised?
and then more judgments either refuting or con-
firming the experts' Concern; 

. Peoplel here understand that if a proj- 
ect ought to be stopped because of environmental
risks, the earlier it is istOpped, the better as we all
are. What Ireally huris is going all the way through

much of the research and developm?ntand than - . .

 

 

urn-I'm

. 



'Eatly 
1 .
?nding sombthing that invalidates all of that

prior work. 2 I



I Is it'a problem to keep this con-1.. 

servatisin (?ll potential health and environmental . .

and proiduct development?

risks om'dhmpening enthusiasm for research
. 

 

The conservatism I?m talking about
. is not in it?s in being r'ealiStic

researchers and developers to do theirhomevt?ork?

befo new rogluetls are put to the market td?st. he
goal is to m-?ke ealth and environmental cone ns
an?integral part of our business thinking just'as raw

material and costs, retumenj'nvestm 
rile t, and other considerations-are part of our.think?

 
 
     

. Instead pf being a deterrent to innovation, I see
I approach as a stimulant, for it means 
can proceed3con?dently in-the development and
marketing of a new product because we know, it
sses strictjmedical and enyironmental tests:-
3 It is true that when we put 05; 
ternal review systems in-placeanumber ears 
ago, they m?t with resistance here. But those doubts
have long sihce dissipated. New product de'velppers
know that if it wdren?t for the internal checks' [and
balances, they would be r'olling'the dice every time
a they committed time and money to a new pfoduct
-introduction. . i 

How new isthis early warning?
approach at Monsanto? - 

   

 

ed it, and I believeowe practice it ir'io'r
thorou hly than ever before, but the basic be ce?pt
?isn?t new. For instance, in the mid-Igsos'w'e - 'a
. veloped a new organo-phosphate insecticide,I

marked COLEP, in ourlabs, we 'did some limi ed

field testing under scienti?c supervision. The estS'

of acute toxicitymade by the medical'depdr en

showed. that the toxicity wastoo difficult t:o 5' -

. I
troI; there were too many circumstances in 1ch
the' user could make a smallmistake and suhi ct:' . -

   

himself or herself to an unacceptable risk. So? e' - 

product was dropped, the project was tilled.

- In other-word's, the prin?iplesw ire 

working on aren?t new.'I think that what is n'e . is


easier for new products? . 3 

. v- -i

about aproduct?s?ultimate acceptability. We'want?a?

In' recent years we have and

hich'
promised td'be very effective in controlling ce tai:nf--_ 1
insects After we tested this product, trade- 

. the comprehensiveness of our approach nowl her" .
reviews are more analytical and systematic, 

- begin earlier, more experts are brought in. . 3 3 fax"

. . Wh'yiis the risk aS's'essmerit'process'! 

. . ..-

 

     

As I mentioned, environmental and"
health risk studies are implicit in the deveIOpment
of every new product. The existing products, how-
ever, have the potential for unexpected ?ndings
because when many of them were developed years
ago, what is today a normal, thorough range of
studies was not done. And we are in fact taking our
new'found knowledge and looking retrospectively
at these older businesses.

A well- known MOnsanto example is
PCBs, or biphenyls. We made this
class of beneficial chemicals for nearly 40 years,
only'to learn in theolatc 19605 that they were bio-

'accumulating in the environment. Long before we
understood the possible consequences, we volun-
tarily withdrew from PCB applications where we
felt their discharge into the environment would be
hard to control. And in 1977 we ceased production
entirely because of the public?s increasing percep-
tion that these chemicals presented an unacceptable
level of risk. if 

Hofsuccessful has the early-whistle-
blower approach been in eliminating unpleasant
surprises after a new product is launched?

Technically, it has been very success-
-ful.,.aborting numerous projects that were tempting
labee?seof the needs they could ?ll. Most of those-
.proiects?I couldn even tell you about because they
(ll were killed in early stages by our technical staff.
1 Politically, however we have had one

well-known disaster?the Cycle Safe bottle. We must

have spent more than $100 million on this pioneer-
ing, recyclable plastic beverage bottle. You could
grind it up and make another bottle out of it. We
were even testing a version that could be washed
out and refilled. People thought it would help to
solve the nation?s litter problem.

At every main step we asked the
experts-both in and out of government?for their
judgments on all the data that could be gathered
about Cycle-Safe. We asked, ?Do you agree it?s?
safe?? At every point they said they did. If there had
been much negative opinion, we would not have
proceeded. We even organized a scienti?c sympo-
sium in Bostonthat brought together both those
who opposed 'the ?concept of a plastic beverage bottle
and those who supported the idea. We went as far

as a company could go in encouraging scientific peer

review and criticism. i think it's fair to say that the
scientl? community considered our approach a
model fwhat shohld be done. Officials of- both the
FDA and the EPA congratulated us on our pro?le of
test data I
But a couple of years after Cycle-Safe
went on the market, it was banned in 1977 by-the



0

Harvard Business Review November-December 1981

FDA. The bottle became the victim not of valid
health and environmental concerns but of extreme,
unforeseeable, and in?exible government restric-
tions and interpretations fueled by the intense
political pressures and emotions of the time. We
said then, and we still believe, that the action .
forcing this highly innovative product out of the
marketplace was unfair, unwarranted, and not in
the public interest.

The disappointment from the ban on
the Cycle-Safe bottle was enormous?to say nothing
of all those who lost their jobs. -

It was unbelievable. It is unbelievable.
We gnashed our teeth and moaned and groaned and

cried a lot, and then we said, ?Okay,?we?ve got to

pursue this thing through the court to demonstrate
to the regulatory agencies that they cannot make
capricious moves without being called to task.? We
still don?t have a reasoned, rational response from
the FDA despite the fact that its basis for the ban
was neither scienti?c nor proper and that it had to

reconsider what that market now. The
new plastic bottles you see on the shelves today are
made from polyester and cannot be recycled or re-
?lled.

I?m still angry because it was a very
large, important opportunity for Monsanto and,
when the whole story is written, it will be proved
beyond the shadow of?a doubt that there was no
scientific basis for the ban. It was a mistake made by
the FDA. So what we want to do through our legal
pursuit of the matter is,- in effect, to put a sign up
on the bulletin boards of the regulatory agencies

. saying: ?Be careful. Make sure you?re right before
you make these moves.?

. a
What is Monsanto doing to overcome
. the setbacks caused by the ban?

On a broad scale, we?ve worked with
the Carter administration and now the Reagan ad-
ministration to try to bring some sensible guidelines
into the relationship between industry and govern-
ment. I personally have played a modest role ?in
helping the new administration address the pivotal
issues in the regulatory process.

Within our company itself, there are 
some people who feel that their whole existence
has been frustrated by the govem?ment?s unwar-
ranted action against Cycle- Safe. We?ve reassigned
them we? ve tried to help them understand that we
want to make something positive out of all this. We
emphasize that even if the FDA doesn?t think of
Cy cle- Safe as a success, we do. But I?m sure there

1m

 

are wounds that have not yet healed?~that will not
healias a result of this unfortunate problem. 

Do you make contingency plans
when a new project goes into production, or do you
have special teams of investigators ready to go intc
action if somethingg rtoes wrong?

I can?t think of a situation today
where we would have contingency plans for a new
product as it enters production. By that time, we
would have reviewed environmental constraints to
the point that the possibility of a surprise is almost
eliminated.

Butwe?re ready in case a possible, un-
expected problem'arises that involves one of our
products or processes and we?d investigate the
allegations and develop our data or work with other
producers to deveIOp industry data. Then we ?d make
one of three decisions: to defend the prodUCt, to
change our methods even though production costs
may increase, or to drop the product.

As part of our overall corporate ap-
proach, we established our environmental policy
staff and the environmental policy committee, both
headed by a senior vice president, in 1977. These
new organizations provide corporate leadership and
initiative for managing Monsanto impact on the
environment. They also serve as cheeks and
balances toeliminate crises as new proiects go
forward; they act as a ?watchdog? internally and an
early warning system externally. 

We?ve been talking mostly of new
products and materials. What about investigating
the risks in products that are already being
marketed?

ExiSting products need to be tested for .

two reasons. First, some of them have been around .
for a long time, and when they came out they were
not subjected to modein? testing methods. Monsanto
studies a few such products?formaldehyde is a
recent example?but usually, because the products
are produced by many-companies, they are assigned
for testing to the Chemical industry Institute of
Toxicology, which is {funded by the industry as a
whole.

AnOthei reason is that new evidence
may come to light indicating a health or environ-
mental problem n0t suspected before._Por example,
some of our people are the world?s leading experts
on the genetic and other possible effects of acry-
lonitrile on animals and humans. When we leam
something new about 'aerylonitrile?or any other
subject of research?we?ll test any of-our products

on the market that contain the chemical.
1 4

. tion? 5, or both? -

  

111

  

Benzene is another example that has
been around forever. Yet in the last ten years some
toxicological data on benzene suggest that in certain
circumstances it can be troublesome to humans.
Monjanto IS the world largest user of benzene, I
belie and we are going to be testing this ch'ernical
for quite some time.

So surprises can come from new
knowledge? ?new analytic capabilities?and we really
don know what all of that knowledge means. -

t' 
Discussions of chemical haza?fds 
.so etimes center 1111 ?devil? chemicals." Wha<
liarie these? 

Devil's chemicals are contaminants

?-usually highly toxic or carcinogenic?that are
inadvertently formed in trace amounts during pro-
duction. Examples include the nitrosoamines, 'the
bioxins, and the furans.

You have indicated that ma un?cer-
tainties exist about devil? chemicals. Doesthis fact
complicate Monsanto?s iob?

Yes. During the last two decades. our
national ability to measure and quantify has taken
quantum leaps forward, and this has changed much
of our thinking and added a whole range of ques- .
tions. A couple of decades ago we could measure
chemi 3?1 impurities fairly accurately' in the range
of parts per million. If something was notdetected
in this 1. go, we considered the impuri

      
 
     
 

  

UOH1
existent, ero. But today we ca re many
trace 1_taminants in parts per 1151' 1 To give you

an idc of this technical achievement, one par
trillion is roughly the equivalent of a single grin of

. sugar in an Olympic- -size swimming pool.

Our increasing analytic capability has
permitted us to measure things way beyond 0dr
ability to understand what the data mean. And with
this greater measuringability, society is beginning
. to realize that there? 3 no such thing as zero in this
business of Impurities. Even fresh water as im- 5 
purities we now know. ll

  
  
  
   
   
    
  
  
  
    
  
   
 

Whose iob' 15 it to identify and analyze
devil chemicals?the government? 5, the corpora-
.. 1. .1 
Both. At Monsanto we have spent
millions of dollars in this effort. We are not re?
quired by law to do so, but like other industry
leaders, we consider it our job. Our so-called devil? 
chemicals project is looking for trace contaminants
in existing products, and we have now examined
most of them. We have feund no product contain- 

Eli?l?llirll- Eksl' 

  

 

 

111

ing trace hinounrs even close to the levels that
medical add toxicological scientists believe could
cause harm. As for government, organizations like
the FDA, EPA, and OSHA spend large sums assess-
ing devil?s chemicals, and their staffs work in con-
?tinuous contact with us.

c" 5 your devil?s chemicals project
related to the larly-whistleblower approach?

?The two are independent of each
ether except when a new producr or process is being
examined. Then the presence or absence of a devil's
chemical could enter into the decision whether to
continue development of the producr.

How do you square the enormous ef-
fort and expenditure Monsanto is making to ana-
lyze devil's chemicals with the fact that you have
lawsuits on your hands like the one ?led in March
1981?3 $1.7 billiorti'?laim by a group of Monsanto
workers in West Vifgir'iia who allege that they were
exposed to paramfhobiphenyl and dioxin?

Maybe this suit proves that there?s no
way to do your iob in this" dustry without having
some brickbats thrown-at you. PAB was used from

ntlw?t?gaos to the mid-19305 in the Nitro, West

Vi?rgio?ia plant to produce certain raw materials. In

the mid-19505, studies began suggesring'that pro- 
longed exposure to PAB could cause bladder cancer.
Once this was confirmed, we halted the use of PAB
and put all employees who had been exposed to it
on a long-term health monitoring program.

That program, by the way, continues
to this day. Monsanto?s response was described in
the medical literature as a model for other com-
panies and occupational medicine departments. I

don?t want to minimize the misfortune of those
who may have become victims of PAB exposure.
But it was the company that blew the whistle in
this case, not a government agency?and certainly
not the employees.

How can society take these uncer-
tainties into account when it sets standards for
health and safety?

. . lfwe go looking for a trace amount
of something, chances are we?re going to find it in
some minuscule amount at least. When we do find
it, we must be prepared to take some action or be
convinced that no?thion is?meeded. Again, what has
happened is that our ability to detect substances in
many cases has outstripped our ability to under-
stand what, if anything, their presence means. A:
growing body of evidence suggests that there?s a

Harvard Business Review November-December 1981
threshold for all carcinogens?a level of use below
which theyare not hazardous?but that theory is
nor universally held. So we are far from hearing the
lam words on the significance of trace chemicals. In
the meantime, what we?ve got to do is strike the
best balance we can between possible risks and
known rewards. 

In the media there are many accusa-

tions and much debate about the hazards of chem-

ical products. Is all this debate simply a result of the
scienti?c uncertainties you have mentioned?

Only some of it, and sometimes only
a small part of it. The trouble is our tendency to
confuse risk assessment with risk acceptance. They
are two very different things, separate parts of the
equation. Risk assessment is primarily a scientific
exercise. It is an attempt at quanti?cation-that is,
determining that material at exposure level 
presents degree of risk to animals or human
beings. Risk acceptance is quite different. This is a
iudgment call, not a scienti?c measurement. It is 'a
iudgment that the risk, high or low, is acceptable or
unacceptable.

Who are the experts in assessing risks
as Opposed to those who decide whether to accept
the risks? 

Risk assessment is the job of experts
~toxicologists, analytic chemists, environmental
specialists, doctors, and epidemiologists. Risk ac-
ceptance, on the other hand, is not for experts but
society at large. It depends on the public?s general
feelings about risk as well as the credibility of the
risk assessors, the role and in?uence of activist or?? 
ganizations like the Sierra Club and antinuclear
groups, the aetivity of legislators, the reputation of
regulatory agencies, and so forth. As a result of all
these influences, risk acceptance becomes incon-
sistent at times, with high risks like cigarette smok-
ing being accepted and low risks, despite scienti?c

. assurances, being rejected.

. One of the most intimate links I know
between science and society is this bridge from risk
assessment to risk acceptance. However, this link
is the subject of a lot of confusion.

Where do you see risk assessment
and acceptance being confused? 

. All over. For example, a couple of
{summers ago the saccharin?issue came bubbling up.?
again. Well, before the scienti?c data were in on
risk assessment, the question of acceptance was 
ing debated on Johnny Carson?s ?Tonight? show,



 

in Congress, on the front page of the Ne York
Times and in lots of other places That cockejjcd.
You can reach a sound decision on acceptance
until the scienti?c data are properly struCtured and
analyzed. The data are in 011 smoking,pcn1cillin

'Earlv warning? system - 113 -

comparing some 3,7130 male Du Pont chemists with

more than 19 000 male Du Pont nonchemists 1nI the
same salary categories found a somewhat loqu
cancer mortality rate among the chemists.

and many pesticides but for 1111 enormous number 1 During the last few years the media
hav been giv

or products there are st ill no guidelines or wh 11t-
ever guidelines that do exist are under repair or
advisement.

Let me give you another example.
Regularly our plants are visited by a group of world-
famous pathologists who bring their expertise to
bear on the quesrion of what further improvements
might be made in the environment here Sometimes
Isneak into the back of. the room and 11 to their
discussions but frankly, their discussions are gen-
erally too technical for me- they go right over my
11ead.O11e time I got them together at the end of
a meeting and said: "You know we think (our plants
are a safe place to work, but we re terriblv con-
cerncd aboutl health land safety and we want to do
everything we can to make them better. What can
I do?? And they told 111ch ?Outlaw smoking. Its
danger to health is higher than everything else."

So I talked about this with my asso-
ciates and discussed whether I should write 11 letter
to every employee sharing this scientific perspec-
tivc. We decided we should be very careful about
any step like that. The data measuring the risks of
smoking are one thing, but the acceptance of those
risks is another. Employees have the right to make 
th at kind of decision themselves, except when
smoking is hazardous because of working condi-
tions You see ?no smoking? signs in many areas
of the plants but not in odiees.

How does Monsanto ensure the safe-
ty and health of the public at hand?the employees?

We have an 111-house medicahand e11?
health department which keeps close
tabs on cmplovees? .1eal and safety througha
computerized medical and environmental health
system that we call And detailed epidemio-
logical studies on Monsanto employees show they
are healthier than a comparable sample of the gen-
eral population. Beyond that three or four path-
ologists visit our plants regularly and advise us on
how we could further improve pl ant safer: for our
employees. 1

Overall we?ve set a new all time safe-
tv record. Its kind of a theme you see signs all over
our plants about ?the great safety race. in fact
National Safety Council data for 1979 show the U. 8.
chemical industry second of .11 industries in safety
performance?more than ten times safer than non-
military government service! And a recent study

 

'1
'1


- of the factors 111 deciding whether to go ahead with
(1:11:11 product. But the reviews don? tdeal directly with

lag much attention to problems' in

ehefnieal waste disposal. Is the early-whistleblower

approach a way to head off that problem too? '1

Yes and no. The technical reviews 
ar useful in determining if a proposed prod?iict or 
ess can bC/?mOdl?Cd to avoid creating any
{lift us waste and ease of modi?cation will bcEme

isting waste streams created by chemicals. Those
Stre mis are the subject of another effort underway.
A hazardous waste study team is getting answers
to such questions as: Where are our waste streafhs?
What are the existing treatment and disposal m'eth-
ods? What do projections show about likely inJ'
creases or decreases in dangers: This tcan?will take
another year to get the answers and then?wC will
complete a ten- year plan for handling hazardous
wastes We may even develop a network of re- l-
gional facilities for disposal of wastes created by
plants 111 different areas. . - I

Does this mean Monsanto 

to worry about creating ?Love Canals"?

We can't take anything for granted
ls ther warehouse somewhere ?lled with dru'rns
or chemical wasm left over from some dompan-
Operatio of many years ago? We ve been in busi-
ness for. years. We have surveyed all old closed
waste "res and we don? think any of them could
beconI a hazard. Nevertheless, it IS conceivablel -.
that some ?site was used before the development of
modern record keeping that we know nothing
about. So we live with a certain risk from the paStI,

 

- iust as other generators of hazardous waSte do.

As for thef ure I?m? con?dentt at
technology 15 the country 5 answer. Scientists in
every right- -thinl<ing company in our industry are
being challenged to make products in sucha 'y
that they don? produce undesirable Iby- product. I
think that :15 years from now there no longer 'will
be processes that generate large quantities of haz-
ardous waste- the existing processes that do that I
will be phased out in favor of new sySterns that'!
won When I see people recoiling from technology
because of pollution and hazardous side effects, ill 
want to tell them: ?The solution to those problems .
is also rooted in technology. We? ve gor to give sIdIt-
entists a chance to go to work. . 

 

 

Could you tell us some of the ways 
Monsanto is trying to improve public awareness of
the chemical industry's efforts to safeguard health
and the environment?

We started'back around 1975 with a
program of public education, if you will, called ?The
Chemical Facts of Life? which, we think, has helped
people see chemicals in their broadest perspective.
On a fire personal level hundreds,maybe thou-
our employees are spokesmen for this
public awareness eHort. We cover everything from
symposia and Workshops to Rotary Club meet-
ings, and there are an enormous number of these
smaller gatherings. Monsanto encourages managers
up and down the organization to speak out in their
areas of expertise?to help explain our operations,
our positions, and our policies-and also to be
available to answer the tough quesrions and the al-
legations when they are posed.

Do you'yiew edjucating the public,
then, as an Opportunity to:eorrect illusions about
the dangers of chemicals?

We go .i?urther than that. We try to
point out as clearly as We can the risks and the
Mons nto+and then we show that life in total is
l?nade up of chemicals and no chemical is complete:
ly safe all the time, everywhere. We want peOple
to understand that. The problem has been largely
the dia?s focus on the risks without quite rec-
ogniz that we really can?t live in a contemporary
way ithout the contributions of chemicals. Yet
peop extend to want to isolate the risks, and that
can?t be done.

. benefits of Speci?c chemicals manufactured by

. What has been the impact on the
chemical industry in general of this widespread
public concern over environmental and health

hazards from chemicals? 

ldon?t think the public?s concern has
curbed the basic entrepreneurial spirit of the peo-
ple in our industry at all, nor do I sense any reluc-
tance on the part of young peOple to come in and
cast their lot with'us in terms of career deveIOp-
ment. They. want to come in, and they understand
that problems are solved through human effort.

As I have said, bur ability to identify
trace materials and their effectpn human and en-
vironmental developed very rapidly, al-
most astronomically. And w' skills we?ve
been what we hat we make, how
it?s used??and there are opportunities to
improve the safety and of our products

. are so inconsistent, does it make sense to have

Harvard Business Review .November'December 1981

and processes and our contribution to safeguard-

hing the environment.

Is it difficult to instill and maintain
this philosophy in new employees?

No, it isn?t difficult at all. These men
and women come from a social atmosphere?par-
ticularly evident on college campuses?in which en-
vironmental concerns are part and parcel of life.
And they bring this attitude with them.

We ?nd more difficulty in getting a
few of our longer-term employees to appreciate the
importance and integral nature of environmental
matters. They have done business for so long in an
atmOSphere that did not place very great emphasis
on these areas that some of them now have diffi-
culty changing the ways they do things?even the
ways they think about things.

We periodically monitor attitudes
within the corporation, and surveys over the past
few years indicate that we are making progress on
environmental awareness. But there will always be
room for improvement.

Ywated that government

agencies have made a confusing tangle out of the

business of risk assessment. Do you-see any signs.
that government agencies are trying to untangle 
the mess that's been made? 

Yes, I'm an optimist, and there are
signs of reason and rationality returning to the
Potomac. The learning process of our .whole society
is continuing to advance, and people are realizing
that there has to be an evaluation of all the factors
involved?the bene?ts as well as the risks. For ex-
ample, chest rays pose a risk of cancer, but since
the bene?ts for detecting disease are great, most
people accept that risk. When you Start looking at
products involving more potent carcinogens, the
trade-off gets more debatable, but even in these
cases society sometimes accepts the risks if it be-
lieves the benefits are worth the trade-offs. Alla-
toxin?a naturally occurring substance?is one of the 
most potent carcinogens known, yet it is tolerated

- in foods by both consumers and federal regulators

at levels that cause liver cancer in rodents. So I

think people are beginning to see that life is a series
of trade-OHS. 

If society and government regulation -

much regulation at all?

I




I don?t have any trouble-accepting -
regulation of suspected carcinogens and limiting
.235;

i . -..

 

 



exposure to them as much as possible My plea is
only to avoid snap judgments, or our way of life is
going to be threatened. We ve got to make the best
iudgment calls we can make, and that means ad-
vancing our scientific knowledge For instance, does

aflatoxin cause liver cancer in humans? We don 
know yet.

Different species can be affected very
differently by particular chemicals, and we lack
direct correlations between cancer in animals and
cancer in humans. We?re working on that problem
at Monsanto, but Monsanto can?t do it alone. The
work is going to have to come from industry, gov.
ernment, the universities, and other groups all
working together.

Regulation also makes sense in view
of the fact that risk assessment is a judgment call.
For example, if a very toxic pesticide is con-
trolled in the workplace, with workers thoroughly
educated in handling it, the health risk is small. But
the hazards of that pesticide are obviously greater
and maybe unacceptable if much of the public is
using it without the expert knowledge of how to
handle it.

. 

Do you view Monsahto's testing ap-
proach as proactive or reattive to government regu-
lotion?

We take the lead in testing. The e?xis-
tence or nonexistence of federal and state regulatory
agencies has no relevance at all to the need for our 
testing programs. We consider them 1 responsibility
of being in this business.

Are there cases where Monsanto's -
standards are higher thanithose of government regu-
latory agencies? I

i

There are such instances in the
United States, and outside the United States there
are dramatic examples of this kind. In many foreign
countries where we operate, we have thesame
standards for worker health and safety as in .

St. Louis, even though governments of those?
nations do not require sutIh standards.

Because of testing, is the chemical
industry getting so expendive that small companies
won?t be able to compete?

1

In some atelis it?s getting to be very
difficult for a small, young company. Take herbi-
cide testing, for instance??fall the tests required to
determine how the chemical affects the food. chain

I
and ultimately human metabolism. It would be
very unusual if the three of us could develop a



1

?Early warning? system I 115

miracle herbicide in a?garage tomorrow and have .
enough resources-to pass the testing regimen re-
quired by the government. I think we ve got to be
careful about squashing the little guy by setting up
requirenihnts that aren necessary, putting up
hurdles at are unnecessarily high Today? 5 entre-
merit}: who can create tomorrow 5 Monsantos are
1mpo hint to the country

We understand that since the en- I
vironmental policy/staff was organized, the torn-
pany has bene?ted in lots of waysthe federal level, we have s"ee ,ur
suggestions affect the Clean Water Act amend-
the OSHA labeling regulation certain EPA
air pollution regulations, and others. And as en-
'vironmental regulation moves from the federal to
the State level or even lower, we have been effec-
tive in influencing regulations in a number of 
areas, principally waste treatment and workplacd I
laws and regulations We don' try so unnecessarily
weaken laws or regulations but rather to achieve a
better balance among government indust?l, andl
the public 1'

Let me take the Toxic Substances 1
Control Act, a piece of legislation that was debated
for several years before enactment. The chemical
industry was advising the legislators on the kindlof
legislation that would respond to the problem, and
the law is now passed with the full blessing of 
members of Congress. We were heavily involved in
it and think it?s potentially very good. Now thati
the law is place, a whole range of regulations i
needs teed; enacted to implement it. The existence
of our environmental policy group alloWs us to deal .
with the regulators, and that process
is ongoing. Our data base of information regarding
effects of our processes and products on the environ-

. ment and health is helpful to the regulators and so,

quite properly, industry and government are part-I
nets in deve10ping regulations designed to accord-
plish whateVer the law calls for. 50 We now have 5

1 much more of a collaborative than an, adversary?i

relationshipYou have mentioned some of the I 
promising Opportunities for joint ventures betwten
industry and university research groups. Do you I
see this type of collaboration as ongoing? I I

Yes. So much of the scientific cornIL 
munity is in the academic world that we haveltb
be interested in what? 5 goihg on there. In the past;
business has had little incentive to develop the dis-
coveries made on campuses. For example, say,
that a scientist at the University of Idaho develops

 

 

E.

116

something relevant to caffeine in the metabolic
system. He makes a discoveryfpub-
lishes. and it goes on the shelf. But General Foods
and Procter St Gamble have little interest because
that professor was funded by the government and
so his invention, it it?s patented, cannot be granted
on an exclusive basis. industry won?t take on the
com 'eial develOpment job because, forevery
Idollaasc'ientists spend getting to the invention, it?ll
take IO or 100 dollars to get it to a practical appli-
cation. 50 because they don?t have an exclusive
shOt at that invention, companies don?t pursue it.

Now-we?re trying to change that.
We?ve tried to have a coupling of interests where
we could mix skills and aspire to genuine syner-
gism. We agreed to take on the developmental re-
sponsibilities with Harvard Medical School right at
the outset in exchange for some kind of proprietary
interest in the jointldiscovcries. Right now we hap-
pen to he studying the nature of molecular ines-
sengers, which trigger the metabolic system and
can feed tumors and start cancerous growrhs.

If we can demonstrate that such col-
laboration can be profitable for the industrial part-
ner, we may encourage a whole series of like rela-
tionahips around the world and thereby change that

:5 . . . .
process which involves the .
transfer of academic research into products and pro-

.cesses that benefit society.

Do you, then, see private companies
supplementing the government by bankrolling
campus scientists? 

Yes, I do. The government is clearly-
curtailing?the nature of its investment in research
and development, and i don?t quarrel with that as
part of getting our budgetary process back into some
balance. But there is going to be a void, and I hOpe
that the kind of experimentation going on will be
so successful as to encourage other people, other
industries to come in and help ?ll that need. The
Harvard-Monsanto experience is only one degree on
a circle of 360 degrees.

November-December 1981

[Earned Business Review

-.. .. . 

- Interview .With
EwisElmer

long has Monsanto been
collecting employee health information?

1Mr. Elmer, manager of Environmental
Staff Information: We?ve just started formalizing 
collecrion of this data over the past few years with
our MEE?lI?medical and environmental health in-
formation?system, but we?ve been working in that
area for 40, 50 years. 

We are inst beginning to use MEI-II.
The ?rsr step, to get a system and start it working,
is over. Now we?re on the second step of feeding
the system data, and that will be ongoing. The third
step of getting the data out so we can issue mean-
ingful reports is stil in the future. We have 45,000
Monsanto employelzs in the United States to deal
with and more outside the United States.
So you can imaginethat the job of data collection
and input is signi?cant.



Do you have safeguards to protect the
privacy of employee information once it?s entered
into the MEHI computerized system?



Most de?nitely. The preccss for medi-
cal data entry starts ata plant clinic wh a doctor
or nurse fills out two-part forms to recogemployee
health information. On the top line goesdthe em-
ployee?s name; on the second, the social security
number and birth date. When that form is com-
pleted, it?s torn off belOw the "rep line, so the only
thing that shoWs on the form that gets mailed to
us is the social security number and birth date.
Somebody who might accidentally open the envel-
ope can?t tell much by that. And when it gets en-
tered into the computer, the programmer uses a
Speci?c program that scrambles the original into
a totally meaningless jumble of letters and numbers.
When the information is withdrawn, it has to go 
through that same program to unscramble the let-
ters and numbers. It?s a tough code to break. Fur-
thermore, can receive output with
a person?s name. on it. -- 

Do you monitor for possible health --
effects from-specific chemicals?

Yes. We do Studies for very speci?c
purposes, either in a certain plant'or for a certain 
chemical wherever it is used or made. Ten years '53"
ago, our study data were less efficiently collected. .



  

. 

 

 r. I yppi ?pyw.

 



     

2-11.; 1.1111-

- 1' mill-Z
.

  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
 

 

   
 
 
   
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

    

'Early

warnintg? 11'steii1 117

  
 

All we that someone was either exposed
or not. For example, We had an accident at one of
our pla 1115 in the late forties that exposed a few 
hundred potentially hazardous 1L1els of
the heinidal heine used '11 the time The health
sratu rt 111se worlte rs has been careiully moni-
tored Yer since. WL - followed this pirtic11lari,roup
or emplOyecs?not because any government regula-
tion required it?but rather because we had

no previous experience with that kind of exposure
and didn?t know what, if any, the 1011 term health 1
effects mic ht be. As it turned out, we iamed?mueh
later that the highly toxic contaminant TCDD or
1.1.01" 11 was one or the substances involved in 1111;
acCide 1.1t Back in the forties dioxin hadn 1 even
H?hee chemically identitied.? 

1 1"

- I


Dioxin is one of the devil' chemicals,
isn?t it?

Right?arid it much 111 the news late-
1y because of the Agent Orange controversy and 1
other incidents. We re one of the few com nies' .
with documented exposure records with it.-Now
we don?t know exacrlv how much the people Were

'exposed to during the accident because the scienee

or industrial hygiene was not very sophisticated 30
years ago. but we do know who was exposed and1
what their were. We?ve recently-con-
ducted follow-up epidemiology studies on this
group of workers and found no apparent excess in
cause ofdeath as a result of exposure some 30 years
ago. We?re,ahle to do studies like this with a great
deal inorq/det ail now becat we know more abdut
the speci?c cheers of on peepl?e both
what and how much This is the kind of informa'
tion we are putting into our system? any
noticeable effects on the health of Monsanto eml- .
ployces that might be relevant to workplace cx- 
posu re. 

 


I

Do you think the FDA sometimesi
overreacts when devil' 5 chemicals are found as 1'
product contaminants in very small amounts? 

The FD concern is n01 necessarily
limited to the presence of devil?s chemicals. TheiDe-
lanev Amendment to the Food Drug Act gives
the FDA special problems and rigid guidelines. 'll'his
amendment states speci?caily that nothing man-
made can be added to foods that has been shown
to cause 1: 'incer in 1111 3-: test, of animals or people'lat
any level. On the other hand the FDA permits na-
turally occurring carcinogens in our food supply.

ake aflatoxin, a potent human carcinogen. It is a
naturally occuring mold that? 5 formed on peanuts
and ether grain crops consumed by humans. The

 

   

 

 :tiri

US

FDA allows aflatoxins in U. S. foodstuffs, albeit at
very low levels because it has concluded that

the bene?ts outweigh the risks. We simply feel that
this same sort of rationale should be permitted
with man?made ingredients.

Do the regulators think there are no
hale levels for suspected carcinogens?

This is certainly the prevailing atti~
JEtude 1n the FDA. Other agencies like OSHA and
the EPA are continually striving to reduce ex-
posures to the lowesr possible levels There IS a
substantial body of evidence that says there are
safe levels for carcinogens. We know that many
nutrients, essential for health and even life itself,
have caused tumors when fed to rats at relatively
high levels. Typically the regulators react to a high-
dose animal test by issuing a new standard let 5 say
at 30 parts per millidh. Then another test comes

1 along that shows a carcinogenic reaCtion at a lower

dose level and thegll say, okay, lets reduce ex-

posure to 10 and if 10 is good,a would be

even better and so on.

Well, every time they go down
anotl er increment it raises the costs, some-
redtrernendouslv. And their reasons for what

whey do are not always rational or clear. To reduce
exposure in _a workplace from IO to :1 on
a particular substance may be justified But if such
a decision 13 based on unrealistic judgments, the net
effect can be millions of dollars 1n additional costs
to us and no real bene?t to our workers. When this
happens, we?re faced with a real dilemma. Is it
worth it, or do we ju5t fold up our tent and get out .
of the market?denying the consumer a bene?t and
some workers their jobs. With MEI-II we hope to
build a case based on hard data to counter the regu-
lators? arguments.

November-Dceember 1981

Harvard Business Revi?c\



lntervieuf?zwith
Dexter Sharp

HBR: We? re interested in Monsanto?s
concept of early whistleblowing?that 15, the or-
ganization of checks and balances designed to elim-
inate the possible hazards' in a new project long be-
fore it ever goes on the market. Could you give us
an example of how your section plays this role? 

Mr. Sharp, research director, En- 
vironmental Science, Monsanto Agricultural Prod-
uCts: Let?s take Monsanto?s well-known Roundup,
herbicide. Roundup was ?rst formulated as a di-
methylamine salt, a formulation different from the
product sold commercially now. Dimethylamine is
a secondary amine and can form a n'itroso com-
pound, or nitrosoamine. We blew the whistle,.point-
ing out that we would have had very serious prob-
lems defending the use of that product because of
the remOte chance that nitrosodimethylamine?a
known carcinogen in animal tests?might form in 1
the environment. 50 we developed a new formula-
tion using isopropylamine, which is a primary
amine that cannot form a nitroso compound. 'And
that is the formulated product that we know
today. 

Nitrosoamines have a bad reputation.
Would the Environmental Protection Agency have
refused to register the ?rst version of Roundup
if you hadn?t made that change?

At the time this happened, not many

- people knew about the hazards of nitrosoamines.

We were not sure at all what the position 
would be. It may not have had that information
then, though of course it does today. So what we
did?like what we do today?was not only to antici-
pate what the EPA might do if it had the informa-
tion we had but, more to avoid plaCing
on the market a potentially hazardous product.

If the scientists hadn't been-able to
come up with the alternative formula using isopro-
pylamine, what would have happened? 

Our scientists would have continued
their research until a suitable formulation was
found. The work on Roundup wOuld not have been
stopped. The potential bene?ts of Roundup to agri-
culture were too great to have done otherwise, and
we would have developed seme other kind of for:
mulation.

. 

 

 

 

 

 

 

 

 

 

 

 . 
a - 

4.35:1

 

"-111- 

 
   
   

. 
- 
.

  

1"
1-111

   

'Early warning? system

I Eur

.1. 

 

1h.

  
 
   
    
  
 

When you have to put so much cm-

phasi's on the possible risks as opposed to the like-
ly bene ts is an atmosphere of excessive caution
likely be created?

   
 
     
      
 
 
      
   
      
 
     
     
   
           
 
     
 
   
 
   
  

ENaturally we try to avoid such a_ 1 a
re, but carcinogenicity is only one part 
ation. For a chemical to be _a problem';t 
'public as well as~our employees have to be exptosed
to it. If using initiative and imagination we 
?nd ways to :produce and use that product so at; 
the potential for exposure is remote we would @355 

 

  

  

  

    
   

I'Ent possible the ultimate fate of a chemical if!
ughout the enyironment we gain the broa 
teChnical base for assessing safety Could you give an example oi . 
Monsanto ieduces the risk of exposure? -

Suppose yoh use water in-Fthe nu-f
facturc of a cw product, and you pump that at?ei'
into the Mississippi. After'the discovery a rod-I
uct development work?a dozen or so sta&g ing
from the research idea through biologic al
evaluation} research ?eld tests environment 1 1' .1
chem1stry, :reS1due studies and others?we as if ll
that water is so free of chemicals that there?s 0  I
problem 111i simply returning it to the river'. I the .
studies show chemicals then we ask how 'th water
might be cleaned up, and treatments will be e-l1
ve10ped to remove the chemicals. And we cl

-. that we? can even put the water .back into th Mia,
sissippi cleaner than when we took it out i 

5- Or suppose we ?nd tha ch
gets into tlie air when a pesticide 1 made. ni'ea-
sure the a51?11ant1t1es 1n the air, thethalk to th people
involve 1:1- production-z ?You ve got to tight :1 upl

your system. You can thave an openhrat the e- pu'd

a lid on it. So Manufacturing devises contr ls orl 

modi?es equipment to eliminate that air em ssion?.

 

  
  

     
 

"1111}: 1 You use animals for testing. wico'n
?.131 ?dent are you that tests-of a cancer hazard an1-- 
mals can He extrapolated. to humans?- - .. .-

   
 





    
 
   
   
   
 
      
     

I think thiese extrapolations ar rea-
sonahle. icy have built-111' safety factors th Llal- I
1 - low for vaiiations when the?product' 15 used yhu-
mans. Most peOpIe don?t realize that there a 
plenty of datural products out there that are mor 
inducers rind if it were the other way aroun 
. those nat ral products were tested on anima ?rst 
?they mightnit be allowed' 1n food or animal fie ed. 
i For example, re oi'tedly somel: ody has 
tested on animals a _naturas ubstance 1n Sassafras-:1 
tea and found it Sassafras: -tea w'o'n"t

. 

     
      

    
    
   

1'1'
.

 

 

 

 

be banned because of this, yet that substance may
end up being banned in man-made Chemicals. In

- fact, now that testing methods have improved so
much, natural products such as caffeine and other
substances in plants are being looked at very crit-
ically for chemical manufacture even though they!
occur naturally in various foods. Such manufac-
tured ural products may have useful properties

humans as food preservatives,? for

e'xamp e.

.. Dpesn?t all this testing delay launch-
ing a pesticide product on the'market?

Oh, yes. It may take to 5 years to
complete all the studies?toxicology (including car-
cinogenicity), identi?cation of metabolites, effect of
residues on erops, fate in the environment, and so
oniAll?these data ?go to a petition to the EPA to
establish residue tol rances in support of food or

feed use and. to grapj a-label, that is, precise direc-
tions for use. The data may be enormous?for 
Roundup, for example, 'the ?rst label petition com-
prised 19 volumes stacked two feet tall. And then

. it takes the EPA from 18 months to 2. years to re-

view 11 of the information. In parallel with the .
.tes 5, her ?is still .more work to do?thc stages of -

Qprocessancd product chemistry, engineering design,

. and manufacturing plant ionstruction before actual

production and marketing. And sales can?t start 
?until the EPA accepts our supporting data, estab-
lishes tolerances, and grants a label for the pesticide.

Altogether we may be talking about 8 to IO years
or so from conception to manufacture and sales.

Canthis process really pay
off? - - 
- if we have found a new chemical
that has unique biological?effects and can solve a
major agricultural problem, the process pays off.
Furthermorehif we can de?ne the fate of this newly

created molecule in complete terms?what happens .

when-it is consumed or leached into the soil or
changed by sunlight?we?re going to be a lot better
off. W'e,necd that information to defend the prod-
uct uses and effectively communicate our knowl-
edge if people'begin to .worry about the product.

users. Second, we want to make sure that company 

 

 
 
 

Harvard'Business Review November-December 1981



- . .. 

Interview with . 
Dr. Roger?Folk? -. 

 

HBR: What is the aim of the Environ:
mental Health labs? .

Dr. Folk, director, Environmental: . 

Health Laboratories: First, we want to make sure
that every product made by the company is safe for ..

workers exposed todifferent "chemicals in testing
and manufacturing are safe. 5
When you say "safe,? do.,you mean I 

in compliance with government regulations?

3 . .

.ohi . . . .

i We try to go a: lot farther than that.
We could never keep the scientists here motivated
if we saw 0 .j?b as just checking out new products ..
according to standard protocols. -That would'be 'mes-
merizing,?it would be like putting hubcaps on the? 7

- assembly line in Detroit. If we get to :73-

weigh all those test animals and do it just like this, 0

at the expense of other observations,? we?d be

trapped.
How much farther-canyon go, then? .. .

?We want to fully understand the data

- we generate.?We have more data on our ma- . 

that is a little bit different, from what we expected. -
. We don?t pass it off and say, ?Wedon?t-have to I 

- apparently minor discrepancies. The discrepancies 

terials and products than anyone else has, and we
want to make sure we ?know vhat those data are
saying, regardless of whethe'_ the government or 
anyone else is concernedLet?s say we see something in the data

worry about that.? We?re interested becaus ,we?re l'
scientists and our training makes us intere ted in i

-.. .
. 

may?turn out robe the most important thing about 
awhole study. 5 

. Also, we?re inte?rested beeausesuch 
an approach will preduce better risk analys'es'fo?r -
"the company. Finally, we?re interested b'ecause??_ - 
we?re attract better people to
the labs if we?fo?ster a spirit of inquiry here. There's .
aIWays abig piece of everyscientist'that has to hold_ 
onto the inquisitive attitude'learned in?sch'ool, and . 
.I want to encouragc'that in'novative?and e'n'tre-f j: I
preneurial spirit. -- i . i 

.mm-"w-un-nn r- .51 u- on

1111cause administrative problems?" . .

L. "are- .

   

 

 .114. 'ti' .. i .- A-ill-? 1 1. ??11-?'Eaily warnihpj system . 121
a i

I

- Well, we can put up with too Irany.
1 geniuses! Most managers including myself are )ust

   

Em like :fconductor. I make sure d. at all
es play' in harmony without restricting lindi-
?alents.

.

I

to have er'y good scientists?sortie of. the best- ones 
I

I


i What are some of the major di_ ci-
plines represented in these labs?
We have toxicologi?sts. Some are con- 
cg) . with the effects of compounds given tL test':
ti 1:115 in:their food, others with the effects 
Compoundis' 1n the air they breathe. The studies -
dondueted by toxicologists range from short ingle- -
ose experiments to lifetime administration fEa 
compound; to rats or mice. The latter is one fthe 
mosr expensive kinds of study. It costs about i
5500, 000 to do a lifetime feeding study to det r'mine'

{111-11??

 

 

the potential of a compound to cause cancer .13? 
experimental animals. 

5 We have pathologists clinical-chem- 
ists, and histologists who analyze the test an mal?s .- 
blood to d?termine red cell counts white . 1; 
counts, anil so on?eve'rything you would ha e; ldone 1-. 
if you wenit in for a complete physical exam at on. ?23 .
We have pharmacologists who analyze wha hap- f" .
pens to a 'e'ompound after 1t gets into the a:ni- -

mal?s body?how long it stays there how it i 

- creted, how it is distributed among the orga s. - ?t
i We have a genetic toxicology r'oup. it}?

These peo'ple study the potential of a nd to 

change the in the nucleus an d/pro?ducd imita-
tions. T?heigenetic toxicology grou also studies 
the/potential effects of products 015 reprodu tion.
and the ddv?lopment of the fetus?a discipli eI We= 
1. call teratologyhave our own compu er . . r? 
. group that captures and manages reams and reams . f}
of data. I?dr instance; one of our standard st die?s' is 3
- a 90- -day feed or inhalation study. This One uidy
will involire 160 rats of mice and will gener te in .
excess of 40, 000 pieces. of data?ands that?s fa rly 
small, by but standardsThis is justa beginning?I con (1 go
-. . onandonlan I 

I 
.1

 

 



 

Is there a eutpff point on toxieity? 
that is, some level above which a new produ ct is - -
I 

considercEi too dangerous and drapped? 2? .
i

1155,1311: there are no?rigid criteria 
because eyerything has some egr?e of toxic itygif
given in large enough doses. We start with large - 
doses andishortLterm effects, working up to smaller . . IIv'f'


hill?hub .
.

I

 

 
 

   

fr,-

 [?11

doses given over long periods. We start drawing
blood samples for the longer'studies and stage by
stage thestudy intensi?es. In each major stage we
want to see some toxicity, because anything you

can think of?sugar.?milk. vitamins?is toxic if a

large .e trough

dose is given.

If the toxicologists see no adverse ef-

fects at 1. they feel very uneasy with the data. Was
some mg done incorrectlyi'They?re not comfort-
able-u. .tiLthey know the no-ef?fect levels and the
- levels at whicht'oxicity occurs and chmpare the lat-
ter with the highest levels any human user can get
exposed to?and see if there is a good margin of safe-
ty. But there is' no number or fade or formula that
is applied to give a go or no-go decision. bedause
toxicity isn?ta simple matter. 6

 



The-open thciety. the unrestiicted access to knowledge.
the unpla ned and uninhibited association oi men lor its
lurthera these are what may make a vast. complex.

ever 9 wing. ever changing. ever more specialized and

expert technological world. nevertheless a world at
human community. 

J. Robert Oppenheimer .. 
Science and the Common .

Understanding. 1953

Harvard Business Review.

-cs-xu- . .

- 4-

The essential wildness of science

as a manilestaltion of human behav--
ior is not generally perceived. As we
extract new things at value from it.
we also keep discovering parts of
the activity that Seem in need oi bet-
ter control. more elliciency. less
unpredictability. Illjre'd like to pay

less for it and get our money's worth 
on some more orderly. businesslike
schedule. The Washington planners.

are trying to be heiplul in. this. and
there are new programs lor the cen-__
tralized organization of science all
over the place. especially in the bio-
medical iield.

It needs thinking about. There is

an almost uhgoverhable. biologic
mechanism at work in scienti?c
behavior at its best. and this should
not be overlooked.

The ditticulties aremore conspic? i 
uous when the problems are very

hard and complicated and the lacts

not yet in. Solutions cannot he

'arrived at tor problems of this sort

until the science has been titted
through a preliminary. turbulent
zone of outright astonishment.
Therefore. what must be planned
tor. in the laboratories engaged in 
the work. is the totally unforesee- I
able. Ii it is centrally organized. the!
system must be designed primarily
[or the elicitation of disbelieiand the

celebration disurprise.

Moreover. the whole scienti?c enter-

prise must be arranged so that the
separate imaginations in diilerent-
human minds can be pooled. and
this is more a kind oi gameithan a
systematic business. It is iridhe
abrupt. unaccountable aggr'pgation
of random notions. intuitions. kriown
in science as good ideas. that the

high points are made.

_The most mysterious aspect of ditti-
?cuit science is the way it is done.

Not the routine. not just?the ?tting-

- together of things that no one had

guessed at iitting. not the making at
connectionsz'these are merely the
workaday details. the methods of
operating.The'y are interesting. but.

not as fascinating as the central-

mystery. which is that we do it at all.
and that we do it under such
compulsion. -

ldon't know of any other human
occupation. even inpluding what I .
have seen at art. in which the people

. engaged in it are soicaught up. so

totally preoccupied .I so 'driven .

beyondtheir strengih and resources.

Scientists at work vs the look of 
creatures iollowing enetic instruc- 
trons: they seem to be under the

influence of a deeply placed human . -

instinct. They are. despite their 
ellorts at dignity. rather like young

u- ?Isaiah?mir- 

November-Decemher 1981'

animals enga
When they 

their hair at ads on end. they sweat.

 



The wildness?fof Science

In savage play.
near to an answer

they are a ash in their own adrena-

[in:T the

 

answer. and grab it

?rst. is for them a more powerful

drive than teed

ing or breeding or

protecting themselves against the .

elements.

 

- It sometimes'looks like a lonely 
activity. but it is as much the oppo?.
site of lonely as human behavior

can be. There i

5 nothing so social:

. so communal. so interdependent.

An active lield ot science is like an -

immense intell

ectual anthill: the

individual almost vanishes into the

. mass oi minds
other. carrying
place to place.

tumbling over each
information trom_
passing it around at

the speed of 

There is nothing to touch the spec-
tacle. In the midst at what seems a

collective dera

ngement oi minds in

total disorder. with bits ol_intorma-
lion being scattered about. torn to

shreds. disintegrated. reconstituted;

engulfed; in a kind oi activity that-
seems as random and agitated as'

,that ol bees in
the hive. there
- with the purity

a disturbed partot.
suddenly emerges.
of a slow phrase at

music. a single new piece oi truth

about nature..

it is instinctive behavior. in my view.

and-l do not understand how it.

works. It cannot be prearranged in ?1

any precise way: the minds cannot
be lined up in tidy rows and given
directions from printed sheets. You
cannot get it done by instructing
each mind to make this or that 
piece. for central committees to'lit
with the pieces made by other

minds. it does not .wOrk

. this way.

What it needs

I


is for the air: to be

made right. It you want a free to
mat-[e honey. you do not issue pro-

tocols on solar navigation'pr carbo-

hydrate chemi

togetherwith other bees (and you'd

stry. you put; him 

better do this quickly?tor solitary ..
bees do not stay alive) and you do

environment ardund the hive. It the
3 air is right. thesclence will come in .
its own season. like pure honey. 
. .

 

 

From -- 

u?esara can 

  

by Lewis Thomas. .

.. 0 1973 by the Masses salts Medical; 1

Society. 
Originally appea

Reprinted hyperml

. . ..

. Jotrmelol Medicine. - a

   
  

p4

Innminim oasis

what you can to arrange the general

 

 

 


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it 

 



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a
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