Philip Morris
Testimony of Ronald E. Cape, Ph.D President, Cetus Corporation, Berkley, California Before the Senate Subcommittee on Science, Technology and Space
Fields
- Author
- Cape, R.E.
- Type
- SPCH, SPEECH/PRESENTATION
- Area
- WAKEHAM,HELMUT/KAROL SHARPE'S OFFICE
- Litigation
- Stmn/Produced
- Site
- R37
- Master ID
- 1000229536/9811
Related Documents:- 1000229537-9544
- 1000229545-9550 Brief Synopsis
- 1000229551-9552 Introduction
- 1000229553-9555 Brief History of Cetus Financing
- 1000229556-9557
- 1000229558-9560 Special Note to Investors
- 1000229561-9563 Special Note Regarding Founder's Stock
- 1000229567-9569 Board of Directors
- 1000229575-9580 Achievements of Cetus People
- 1000229581-9599 Present Cetus Activities
- 1000229600-9616 Research Plan
- 1000229617-9619 Patents
- 1000229621-9656 Debenture Purchase Agreement
- 1000229657-9661 the Cetus Story
- 1000229663-9667 Cloning Business: It's Growing Fast It's Growing Fast
- 1000229668 World Roundup
- 1000229669-9670 Latin Drive: Brazil Spends Millions to Put Alcohol in Cars and Save Oil
- 1000229671 Can US Reduce Imports with Gasoline? Some Say Yes, But Officials Are Dubious
- 1000229672-9673 Bacterial Insulin Production Hears Reality
- 1000229674 Business World
- 1000229675-9677 Who Should Play God?
- 1000229678 Schering Plough New York Analysts' Meeting December 7, 1977
- 1000229679 Indiana Standard Labels Purchase Offer Part of Move to Wider Technology Base
- 1000229680 Big Deal for Berkley Bugs
- 1000229681 Oil-Less World May Run on Bugs
- 1000229682-9685 Tinkering with Life
- 1000229686-9687 Set for Biology's New Revolution
- 1000229688 Little Black Box of Cetus
- 1000229689-9695 Industry Is Finding More Jobs for Microbes
- 1000229696-9701 Dup of Id 1000229657-9661
- 1000229702-9710 Recombinant Molecular Research at Cetus Corporation
- 1000229711-9715 New Cetus Antibiotic
- 1000229716-9720 Letter to the Shareholders
- 1000229721-9726 Letter to Shareholders
- 1000229727-9728 Letters to the Shareholders
- 1000229729-9730
- 1000229731-9734 Letter to the Shareholders
- 1000229735-9736 Letter to Shareholders
- 1000229737-9749 the Manipulation of Genes
- 1000229750-9770 Microbial Genetics and the Future of the Pharmaceutical Industry
- 1000229771-9774 Recombinant Dna: Fact and Fiction
- 1000229775-9778 Testomony of Ronald E Cape, Phd President, Cetus Corporation, Berkeley, California Before the House Subcommittee on Science, Research and Technology
- 1000229779-9797 Biosystems Poised for Growth
- 1000229806-9807 Statement of Ronald E. Cape, Ph.D President, Cetus Corporation, Berkeley, California Before A Special Joint Congressional Hearing in Conjunction with Oversight Hearings on Science and Technology Policy the Senate Subcommittee on Science, Technology and Space of the Commerce, Science and Transportation Committee Presiding, Senator Adlai Stevenson, III Washington, Dc
- 1000229808-9811 Statement of Ronald E. Cape, Ph.D. President, Cetus Corporation, Berkeley, California at the Annual Meeting of the American Association for the Advancement of Science Session on Recombinant Dna Public Health and Biomedical Research Policy Washington, D.C.
- Named Organization
- Cetus
- FDA, Food and Drug Administration
- Freedom of Information Act
- Institutional Biosafety Comm
- Institutional Biohazards Comm
- Interagency Comm
- NIH, Natl Inst of Health
- Senate Subcomm on Science Technology
- Senate Subcomm
- FDA, Food and Drug Administration
- Request
- Stmn/R1-004
- Stmn/R1-150
- Named Person
- Califano
- Fredrickson
- Young
- Fredrickson
- Date Loaded
- 05 Jun 1998
- UCSF Legacy ID
- fgo74e00
Document Images
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*.
,,Testimony of Ronald E Cape, Ph D , : ,
~
President,.Cetus Corporation', Berkeley, California
3 ~ X ~ f r1°Jd~~t .t ~ .t ,..4 $~~fIt
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.Before the Senate Subcommittee_ on 4N4 t~5 %b, qs
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Science,
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November 10, 1977
f ~~~~~t~~z ~ k~ar l?u
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."`~ 'se,... r '-,~ .,;
s, 7 q,Mr Chairman, and Members of the Senate Subcommittee on Sci , ence; Technology
dT' - ~ ~ {.~ Z1f.J.# J
and~ Space. ^. ~~~~ f~it.
.~`~. ~
Thar.k you very _mucb for this opportunity to participate further in the
a
~~^}extended public, national discussion of the question of regulation of re ''
_}i : !>_ . . - i ' _f f. ... . .. . . _ .. .. _ ..:,;i''~'
combi'nant bNA research: 'Thanks first to the initiative of conscientious
V;l . _ ;.
'scientists engaged in this work,- .r and later to the active interest of many ~
.r:...~...s.. : . . . . r.~
others, it-is indeed true. that,`as Senator Kennedy recently said, "for the
irst.time the principles'of public accountability are being applied to
~
`
l
~~ « e t, ,;the nation s science`policy. .This is good. Much `resentment has been
expressed_over the manner in which broad policy matters that profoundly ,r :Y s f ,~ti'at ,.v sifi a
... t .-, . ., . r
h
~.affect ail of us have °hi share storically this been made, unnecessarily, .in secret, ` _
. ~~ . ._.. . - . .. ;.: .-..
« = J ~
.; y~ , g ,Ps
decision-makin ~So we hl,l aneat against elitist '
,
process the chance to be heard
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My remarks will follow ~the flow of thought in Senator Stevenson's letter
ry
{ inviting'uie~to appear here today
- , -. . . ... .'r ... . ..1 . r. .../. .`x ~ ..
YCetus Corporation is a`young company dedicated to leadership'`in the com- ~~.~fi. .
~
tnercialization`of molecular biology. For the past five years we have
x= i :.r:..> K Q: h
~ been working'to'improve the performance of certain industrial microorgan
isms which;produce antibiotics and other pharmaceuticals.' This improve-
ment makes'the drugs cheaper and more available. -°Recently"we have also
ment
1'been working on industrial processes not related to drugs. We have not
r
.. ~~ s
t,j
at:
i~: ~~8~yet ~beg.un to work with recombinant DNA. , However, we announced many
t~_ . pxp tordo so. We have therefore been'
s4~' ~ ~months t ago . that we ho ed and e ected
~ 6,,engaged for;some tune in_recruiting sophisticated staff, building appro- < ~
/ .
~
riate containment ~,facilities; Jinteracting with all levels of government,
a~including'those`insour"local communities, and establishing procedures,
:,.: -- '~r..;,. _ ` ..' ..~
~ including those relating to biosafety. All this coincides with our hope
.
of beginniiig'this work late in`1977 or early in 1978
"..- . pSj. .. .
..A
.r..=..
t . .......... Y _.,,.!
tK~<
P2 andltbegin'with`two"scientists and their technicians working first in
hen in P3 facilities,.intending first to find plasmids capable 4A4
o}frautonomous replication in relevant industrial hosts, modifying'the
4pla,smids tosuitable cloning vectors, looking for insertion sequences
and transposons, and developing transfection' or transformation systems ~
for particular host organisms. < v ~:
DNA fragments in microorganisms.
};_.In7a.,
ddition we will explore potential applications of chemical synthesis ~~
of DNA molecules to facilitate the isolation and expression of specific ~,
-.. +~ie.: ?.. ..
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In the process of this and other work, we expect to staff our current
?facilities with perhaps twelve workers, but it's' hard to foresee the ex-
F:;pansion timescale, as you have,requested us to do.i''=Our expansion will be
:as rapid as possible without sacrificing the highest standards of exael-
lence. Sometimes that imposes `itsown timetable limitations. Certainly,
for the foreseeable future, our activities will be what everyone would
agree is research. There are no plans at present relating to production ~
or what could generally be regarded as commercial exploitation.
0
,~~r.To relate this specifically to the NIH Guidelines, in their present state, 'p
'
~~ :', the ten-liter limit presents no problems to Cetus' Corpo=ation:'''~
fJ
a
4
. a,
But we want no misunderstanding.'.Cosmercial development is our ultimate
~ objective.' ~With this in mind we have been especially careful not o'
~; accept public funds nor.to solicit government contracts"w;The corollary
of this policy is that we do not finance or sub-contract any work outside
our own laboratories. We want no question ever to arise regarding the
ate'ly :for
. ownership of our accomplishments. `,We are in business; ultiM
~
~
rofit, and keep that constantly in mind in planning our program
~
ou ask for our estimate of how Jlong it will take industry to produce
s~
marketable applications of recombinant DNA techniques: `Cetus`habeen
championing the enormous and oertain"industrial impact of all'frontiers
`
of molecular biology. We have repeatedly stated our conviction'that"
c
,~,scientific breakthroughs in this field will occur far more quickly than
_ .,d it"
man, people think. The pace is relentless. Anwill continue'some-
..
where in the world regardless of legislation or controls: 'We -are con-
1978, '
,~ vinced thot there will be many exciting scier3tific developments in, ~p
~'
°1979, and throughout the 1980's. Every tizne a scientific hurdle is suc-
: cessfully leapt, as was accomplished when the ratinsslin°gene was cloned
.
~tnR: ~
,,in E. coli, we will identify it as a necessary step towards ultimate com-
,mercial developments of profound significance to human welfare~
, ..~1 ...~~} ~wJir.~
w
`
. '?..,_~ ~fJ::.1
~,,But let me get back to insulin as an example to u"se to try to".answer
~.,
,your question. There are many hurdles between cloning,_,and en eress-
er
O,jng the genes for insulin in microorganisms, and thultimate'haressin
~g
s4r of this capability. For this reason, our answer to :your { question is'"that
:~"
marketable applications are still very far awayYour question implies
'_ a true future return on today's investment. ` That means'sales to"users,
"
.at a profit to producers. -Human insulin producedby.fermentation'is'
<.f `~,; among the easiest to crystal ball. We can intelligently guess`what the
~,.economic and health benefits will be..}Our guess,,for insulin, is that
this is at least ten years away. Many other products"which rent
DNA techniques render possible are totally new ="some'cannot even be'
imagined today. So their markets are impossible to.predict, much less
their timetables. a
most of the~
I want to stress the following. First,gLory in these
programs is in the early stages, the accomplishments currently receiving
much attention, and centered in university laboratories. - Second, most
~of the cost and the time, and the drudgery is going to involve the later
stages. And much less of the glory. There are practical manufacturing

problems, toxicology testing problems, clinical effectiveness testing
;;problems,~all the appropriate FDA problems, record-keepinq problems,.'an
"'-finally marketing problems, to be successfully dealt with before we can'
talk about'real return"on investment. :And gentlemen, in our society,±~
-p
. ~ ,T- . .. . :
...where all of that can get done in the private
there sonlyone4place'
~ P~ sector,Xwith rofection"~of'ProP "rietary secrets and cometition as the
' ~
.
y,.. ~ . . .. . . . . . ... .
ground rules, and profits as the motivation. If there is an alternative'
n our , society,` 'I ani not aware of it. ` This upsets some people, `:and their A
iscontent'with this fact of life in the United States today has 'obscured ",
the issue; `and they present arquments and non sequiturs which make it p.t
~
.~.; ; ,
ir'
~ appear that recosabinant DNA is a threat '-°Thereal quarrel is with the
~t'structure~ of oiir society ~. : ev
~0f.. t~As
. ". ..~.... . ~ . . . . .. .- -
,`"
Nowthe fact that commercial rewards are not around the corner represents ,
an "opportunity,- I think. "'Contrary to public opinion,_ industry is not
hurtling forward in recombinant DNA work. `I disagree with the assertion~
that industry will"be more motivated to play loose with the law in its ;1
'hunger,"'for`I have'spent much time in both worlds, and I'm hard put to±,~
~
hoo'
;::cse where I've found more impatient, ambitious people.' The entrepre=~
neurial spirit exists in both the academic and business worlds"cThe over -
this field is being done in the ~ '
whelming majority of work being done in4
public sector, financed by NIH. Granted, some industrial spokesmen are
,t
coming out of the-closet and belatedly admitting interest and even activity
.
1
in the field; but the effort remains miniscule, I believe.'=3So we have an ~,_
mine" `'
opportunity torexathe issues without undue time pressure.~"Cetus
Corporation favors'federal legislation on recombinant DNA - to facilitate
. "the prudent development of`the technology -'not to'prohibit'or'unreasonably
restrain" it.'' To those who1-fear that the failure of present*regulations "'-:
. .,,",
; to qovern fn'the~,, pri~vate sector represents a loophole that must be
'closed, and olosed quickly, while there's still time,'I reply that the
.,.:NIH Guidelines already effectively apply to industry,'that there is no ~.,
t
:f.loophole, and that hasty, ill-considered legislation imposed because of
_.
lahis supposedrneed,would be a response to a non-existent danger:'"But
~ 11 return to this point in the proper sequence j-`Y"~ r~Ea
~Q'~HYfhi+t/..'i.'.:.LN~~./~
~
'As'to interpretinq the NZH Guidelines and translating them into actual -s'`:
practice, in general, the NIH Guidelines are quite clear.''We anticipate"
r:little difficulty in translating them into practice. However, we would
`,'-like 'to make a 'few points. 10 ~s01
; Currently, NIH reviews MUA's-(Memoranda of Understanding and Agreement)
e for NIH funded grant requests.''''The MUA's are specific"and usually ap-' z
',pended to detailed grant proposals giving approaches, goals and protocols.
'.'Industry, however, depends on secrets and competition. We believe
Congress wishes this to continue. Clearly any information a company
would provide in an MUA would have to remain confidential, proprietary `:,
and exempt from.the "sunshine" provision of the Freedom of Information
Act. In addition, the current Guidelines require that the minutes of --
the Institutional Biosafety Committee meetings be made available for ~:
public inspection. The proprietary ramifications of this requirement must ~
be obvious to this Senate subcommittee. ~ ' `~n~ 4:'"

.a~k .~ ~.J..
.
-..
.] -:'~'~''ij~~.7~ S fjP~l'~Xt?'~~i~ .
., .. There will always betechnical observations on theGuideli thl
`nesemseves,
11
_ and this is not the arena for detailed discussions. 'But, by way of illus-
ines
tration, the ciirrent Guidel are vague on alternate procaryotic host ..
_. _ :.. . -.. . .
.,:
a:;vector systems.,;;Apparently,'one must have approval to develop new host--
vector systems that must exhibit,"at least a moderate level of biological
. .
containment ccmparable to.EKl systems"...and "the host is to conform to
the definition of a C1ass~I etiologic"agent." ,,Many industrial microorgan
;isms (e.g.' Streptomyces spec~es) are non-pathogenic, soil organisms~that ~~a> `
:w ~
L .~
do not±cause Plant human or other animal diseases yet seem lumped to~
~
. .. ....~I ~ -
...._ ...... .. of Y 3~~
gether under the heading of Actinomycetes as Class II organisms ?This is
"important to us because we want to develop and genetically understand new,`:=' ~ t~i
safe, non-E coli industrial host vector systexns
~~_r~ ,v" i
+'=i~~'i
.,
Now we
come to
the central question in your 1etter How do fl *
. weee
~
in th recombinant DNA should be regulated p ivate sector?;;~ys~~~~~ ~fa
er~~~ol-~~
~ u r
~.~"!
. .
Our answer is simple ,as closely as possible to the regulation chosen for ~'~~+~~
..._
...;
the public sector. _The hazards, if any, are the same. There are differ-
......
~ences, to be sure,,,and I.will address some of them, but the similarities!
far outnumber the differences.'+`
~ ~ fi`
t".1
'
`
re saying is that the NIH
,~What we Guidelines should apply to.indust.ry. .~~ 4 ~,.,..
Z!11 go further, and repeat,my assertion that they already do! .,.Operation-
°:ally, we believe that the NIH Guidelines represent the only recognized
..standard operating procedures~for such'work in this country. Cetus Cor-.
~:poration asserted its intention,to adhere to those Guidelines before they
were pso>~~slqated. We cannot imagine any responsible co:npany, mindful of
potential legal and liability implications of doing otherwise, permitting
this work to go on under any procedures other than the standard operating
procedures governing the vast bulk of the work done in this country
3G` :' u 5. r.~ .. . zt:. .] ..7tS ' f1o',-l ~., ~SR 1.7 f . . ~ !'
_
"
In our own case, there is further validity to the assertion that no loop-
hole exists. Both Emeryville and Berkeley, California, where we_operate
our laboratories, have passed`local ordinances stipulating rules which ~
eliminate any doubts. I submit documentation regarding those,city council
resolutions herewith for the printed record
aYS
9w.' r .',';c3» i
T
You may ask why, in the light-ofthese assertions, we still favor new'
-
federal law. There are several reasons.
}~
i
I would like to reply first to the question asked of the previous panel_.
;,about existing law. The Interagency Committee chaired by Dr.Fredrickson,
which prepared a report which-was subcnitted to Mr. Califano in the spring,
had appointed a subcommittee to.look into this question of the extent to
which existing law, environmental law, occupational safety law, and so~';"
forth, could be used to provide across all sectors of our society this'' `"' '~
kind of protection which many people were demanding at tfiat time.
,..-..
Their conclusion was that no one would be satisfied with that approach.
-That conclusion was incorporated in Dr. Fredrickson's final report y`

A second reason why we_want law in the reasonable future is that at pres-
_~;~ent, NIH Guidelines are written for NIH grantees,;~This makes it awkward,
°sometimes,,''for industrial labs to comply with the letter, while complying
a,~~wit~-the spirit of the Guidelines. For'example, ifa lab is not an NIH.:
~
.:
grantee, it~cannot avail itself of NIH's services in reviewing its Memo-:`;
.;
randa:of Understandingand Agreement (MUA's). A~technicality -,a loophole
.
,w' perhaps'~kbut one which we would like to see closed. .We want to be treated
°~ ~~both in the letter as~well as.the spirit like everybody else in terms of~',
~ ~t~ose,.Guidelines. ?",We want diplomatic recognitionl
;'Y $,~~
;=The last reason we want law is that there is genuine, albeit misguided,
-.::.,.., . .. .
dustry can ignore,`
public concern;_srising fram a feeling that in
and is
, - ~««
~
,! . "
~ the ,Guidelines. ;. As I've mentioned, some are sufficiently , R~;~~ ~+ x~
Zanxious on this_point.,that they urge what we feel is overly hasty legis-_:;µ
lative response. While we regard this demand;forimmediate legislation
as`inappropriate,,we nonetheless respect_and understand the anxiety. We
eel that.all parties to this discussion will feel better if legislation
.s,ultimately.enacted which draws few distinctions between the public
~`:'and private,sectors, and no distinctions at all where safety is concerned.
_ .. ., .
ry
But let me"_say ahat,society's actions will governonly sane persons. -No ,_
;'guidelines, regulation, legislation, or punishment.will control insanity.
`
One distinction bears mentioning here As I've said, industry isonly ,.~
s s~beginning thiswork..,; By way of contrast, recombinant DNA research has
,~~ :~;represented_a_major,component of the best biological research at our top
D ~~universitiestfor at least the last five years.,The.impact of regulation
, r
llthus be felt much more strongly in the public than in the private
_ y';;sector ':~This is"especially true since industry has had to learn to live
with regulation of all aspects of its life; university graduate students,
post-docs, and professors have not been similarly exposed. -
141
~
jThus it,is-particularly important thatlegislation and the attendant en-
:'forcement be reasonable.and respected by workers in_.the field. Onerous;
,. .
_ irrationalrules will create the possibility of violation or scientists
- JrY .:
"
moving out.of the country. Zn both cases I suspect thepublic sector
may be more yulnerable.,~;In any event, such a response will not serve the
Y
publicinterest.
Vll make a.few comments on features we'd like to see in legislation We
wish to stress flexibility,.uniformity and specificity.'
dY.rt>~t,
`
;To repeat, developments in this field will continue to be dramatic andy
"
'We'
;'particularly illuuainating with respect to biosafety considerations.
urge, as have others, that the NIH Guidelines, and any law covering these
activities, remain flexible, to reflect this growth of knowledge. Wi*_h
the passage of time there will be a diminution of the need to,depend on
speculation, and scare scenarios, and worst case fears. Many feel that
even now, on the basis of factual, experimental inputs of the last three
~years, the NIH Guidelines are too restrictive. Much has been made, re-
cently, of the possibility that Nature is not obeying the NIH Guidelines.
And although,.as Dr. Young mentioned, Nature does not use recombinant DNA
technology - that is, doesn't do this in test tubes - Nature does use "'

`cryptic plasmids, transposons,-and the like. In other words,'`it's the
same ball game, in a different ball park. We therefore applaud the contin-
uing modification of the Guidelines. Part and parcel of that process'is
.the active encouragement of experiments which will continue to provide 4his
feedback. Let's be sure to keep this flexibility in any legislation,~so
``~that we don't permanently saddle"our research establishment with regula.-
;`3:'tions that become increasingly inappropriate and thereby the object of ridi-
;cule by workers in the field. 'I want to repeat, we would like = and'I think
everyone else has stressed this ='we would like whatever legislation'is''en-
acted to reflect the flexibility which already exists in the Guidelines.
.. L,'... i:. :AsW'} V
f,,
.,1 T...
We therefore endorse a"sunset" provision in any law..'The regulations'-I,
address a need perceived today. `"Let's extend them'only if the perception
"of need persists, and always with appropriate modifications.
....~~:vs
_ ."'4Xl M"~-CL'''r~^:'Cr:r .
Next, we want a oertain amount of specificity in any law. ''The NIH
Guidelines are an excellent model. The entire research community would *
be paralyzed if actual'implementation and questions of liability had to ~~~~
wait for the promulgation of regulations by some as yet undetermined
aqency.` ''Nor do we -wish to-wait for the courts to write the law:"'
Lastly,/we join with others in hoping that federal legislation will bring
-uniformity into what threatens to become a hodge-podge of local regulations.
We enthusiastically endorse'the recommendations of the Interagency Committee
chaired by Dr. Frederickson, calling for federal pre-emption.-=There is some
indicc~*ion that some of the pressure for local and state regulation has been
motivated in part by'a desire to goad Washington into action,'particularly'
.since it was felt that the apparent failure of the NIH Guidelines to cover
'industry represented a realproblem.
_ ~, ..... ... .... :. .,~ ~; - ,,,.
Cetus Corporation endorses the concept of licensing facilities to perform
this work. -It serves the purpose of forcina all who wish to engage in it
'to identify themselves, and'to be subject to monitoring and inspection.
We also agree with proposals which would deprive any who fail to comply
-of the opportunity to profit from this work. It has, for example, been
~suggested that failure to adhere to the regulations should result in the
loss of the right to obtain patent protection on the outcome.'
"W'hich elements, you ask,-will assist or impede the small,-private indus-
trial laboratory in developing beneficial uses of this technology? My
first reply is to express skepticism that it is possible for a really
small laboratory to develop this technology. Partly, this is due to the
enormous cost of an developmental program in biologically based industry.
A small company might, conceivably, demonstrate some scientific break-
throughs of genuine significance. But I've already expressed the view
that this represents only a small proportion of the total effort needed
to bring any development'to market. So, in our view, there is a size - -
threshhold, or if you prefer, there are membership dues in the club here
which a small company will not be able to afford. Without question, the
:special needs of recombinant DNA research - containment facilities,'-=+>
certain sophisticated equipment, and the costs and procedures'attendant
_ .~- ...~~.

~=on regulation which,-for other reasons we'feel`is`desirable`--will all
:~~ combine to raise'the price of entry. "Legislation should anticipate and
penalize any attempts to end-run or short cut these legitimate costs
V:+d
'
w;"
No°as to our local~and biosafety activities. ;°Cetus Corporation has'?
,
.._.,
i;sbeen in touch with local authorities in E~neryville and Berkeley making
,.our intentions clear long before any implementation.'1I have already .=
'mentioned'the recent passage of local ordinances. -We also have been
interviewed by and continue to interact with our local press ~ *°~ ~'
.~~
We feel the NIH Guidelines specifymini.mum requirements, and therefore
?,because we-feel business should be conservative,`not because we consider
;:the Guidelines too lax, we will provide facilities with a higher degree
"
:`t=of physical containment than required by the Guidelines. In addition, V: :.
we will develop personnel procedures which exceed those specified in the
I
~Guidelines. The Guidelines require the formation of an Institutional
^
iohazards orBiosafety Committee to provide information on containment
1
o iiistitutional personnel and to certify that the physical containment
criteria are available for each investigator's Memorandum of Understand-
ing and.Agreement~-(MUA).'`'The Cetus Institutional Biosafety Committee is
currently;in`the`process of being formed.' The Committee will be com-
~prised of inembers from Cetus, some of whom will not be directly involved
*11'in'recombinant DNA work; and'it will also include non-
Cetus members from ~ Y.
.4,the~community who will not be permitted to have any financial interest
n Cetus and.who,;laill'be_'asked to:.serve for a single.n,on-renewable three
year terin."`The Cetus Biosafety Committee will have a, direct role in the
determination'of"procedures and safety requirements.''The Committee will
..be competerit to`addressexperimental design, safe handling and contain-
" ment procedures,`'design of monitoring procedures and, finally, the eval-
;}iation of.potential risk to the experimenter and to the community. The
-~'Cetus Biosafety Committee will have the responsibility of approving,
modifying or rejecting all proposed research protocols involving recom=
~;binant molecule research to assure environmental and personnel safety.
y
..r;
You ask-about patents. We welcomethe award to Upjohn of a microorgan-
-~~ ism patent; ,' We think f t entirely appropriate; -'as the 'ever 'greater abil-
~ity is now maiiifest'to_purposefully construct entirely new organisms to
') ,s.. _:, . _ ...
;do previously,impossibLe and uniquely useful jobs, that those who suc- ;
1;ceed in doing so be'permitted to patent the results of their work." We
.feel,1further,athat^this policy will encourage the useful development "~
-of recombihant DNA technology.
j1.CS~.:~7;iI"L''"i ..0..
~
tLet-me reiterate."'These patent privileges should be denied to any who
`'fail to adhere to the Guidelines or to the requirements of the proposed
legislation. But let me also identify the naivete implicit in sweeping
insistence on early'disclosure. Present law may present a Catch-22 -
early disclosure amounts to publication, and publication may mean you-
can't ever get meaningful patent protection. If we don't eliminate this
Catch-22, then I submit industry will not develop the applications of
recombinant DNA technology in this country.
. - _.. , -.
~W _ ".: r s93
If industry is to carry on work in this field, ways will have to be found
whereby the disclosures called for in the name of safety do not compromise

the proprietary or patent status of industry's plans'and accomplish;~ents.
Unless this is successfully addressed, this country will be withouta mech-
_'anism for useful.exploitation of a technology which was invented in thi'!!-
-country, and which will certainly be exploited elsewhere, as you pointed'
= -.
out a few minutes ago,;Mr...Chairman. ~,Unlike nuclear technology,.DNA.tech-
nology can and will be developed.elsewhere without any ability-whatsoever
.
of the United States to control or even slow it
~!ri:3':"~xr~' '3fi`{
..~.Y.~1dP:.+tA
Now finallyIwould liketodisc.thlltihiu'
_,_uss.e aegaons to wch yo refer, '~
Mr. Chairman, that industry may not adequately address possible ill ef-e
fects of recombinant DNA_.research ,yIt is my view that industry 'can
,,, .
.._... ...~
scarcely afford to fail to,address these ssue.s.~
i
,~:Insurance and liab
ity considerations demand noless `'.In thi idtillb
.;s area,nusry w,e more
highly motivatedI.fl thll b thbli~
,..ee,an wiee puc sector. -_Probably this '
is a fruitful area foti bet the t
r.,cooperaonweenwo sectors
' implyczrnot subib ttio tht i ihy
_.screo an asserna our sectorsnerentl
characterized~by baser motives than other sectors, and ipso facto cannot
`etrusted to continue it iliit tkhih i iliSh
~smpcas, wcsmpementaton.":,uc _.... .<,,._. .. .:. - . ..__ _,,
....
Ms~n assertion requires a reassessment of our entire system, andf,I think
.
that is quite beyondthe legitimate scope of this particular public.de-
~r
_bate:;tThis public debate on recombinant DNA has been remarkable in~the ~'
,
... ~.way in which it has spotlighted a whole series of major issues with which ;... ~?
our society must grapple; in the process, recombinant DNA has been taking
brickbats fromcritics on all sides. Some of these critics have usefu2 ' '"4~
. :..,.
°'obse w.-tions regarding the difficulty our society seems to have,in deal-
~ing with the environment,:with disadvantaged minorities at home, with ,, ",
;
people and countries in need elsewhere, and even with socio-political
issues such as eugenics elitism in science and in public policy dcisi
,eon-
m n
aki
g. Although I view with alarm the doctrinaire polarization whlch
;.pervades these discussions, I am personally in sympathy with some of
e the
views I hear expressed regarding this wide spectrum of discorinec d 1 s , _ .. . ;
t ;, ,. _ ......
. sues. A.,Except_for one..
thing. Most of these critics are exploiting" recom-
binart DNA more than industry ever hopes to~ The ar using it,'bcaus
..yeee
;,'itm provides. them a_ platform, a soapbox, and indeed, a_ whipping^ boy in ,a
~
-._public_-debate _that deserves better; it deserves toe bedealt with,on its
"'own merits._, More general issues should be labeled as such and addressed
as such, as Senator Schmitt's general science policy bil1,.~I,understand,
.
.:, .
proposes to do.. I agree with the apprehensions ascribed to Drs.,Suzuki
h
and Beckwith_as.. . to__ow our society deals with ' environmental_and occupa-
tional matters. I admire and salute their dramatic gesture-of declining
to work in this area to draw attention to their point of view. I entirely
disagree, however, with their contention that recombinant DNA work is in
competition with funding of environmental and occupational safety programs. ~7"A
.C'~i ~~
lT
Mr.-Chairman, we ask the American people to deawith this specific
problea+,on its own specific merits. We must decide whether DNA technology ~:
isgoing to be developed commercially in the United States,"or whether'
~
.
it is/not. :,Only industry is configured to carry out this.development.
t ;`
We have r"entum, and we want to continue to build.._. The people mus. _ ,. ..... . . --- ,~..._..
_:: _
decide if we will have that opportunity.
3.:~ ~4.-i.w r~l.. r' ~ .:nn
iThank.,
ou
:i'~_n y
