Recombinant DNA research and its applications

    Front Cover
        Page i
        Page ii
    Letter of transmittal
        Page iii
        Page iv
    Table of Contents
        Page v
        Page vi
    Summary of findings and recommendations
        Page vii
        Page viii
        Page ix
        Page x
    Introduction
        Page 1
        Page 2
        Page 3
        Page 4
    Part I. Principal findings
        Page 5
        Page 6
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    Part II. Recommendations
        Page 23
        Page 24
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    Appendix
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( M I TTEEiiiiiiiiiii~i iiiiiiiiiiiiiiiii~i PR ... I NT]ii~ii !ii ii

co m m as~iiiii~~iiiiii~~iiii i



REOMNN iiiiiiEiiii AN
ITSi APPLICATIONiiiiiiiiiiiiiii
........... iiiiiiiii~ ii






OVERIGHTRE T

I4





SUCMMTEEO


iiIEiiEiTECHNOLOGYiANDiSPACE
iiiii~iiiiiii~ior Mii
SEAE OMITEO

PO OSCE"E ADTA OTTO



























COMMITTEE ON COMRE SCECADTASOTTO

HOWAR W.' CANNeadCara
WARREN G. MAGNSON, Washington JMS B EASN Kna
RUSSE B. LO, Lousa R .
ERNEST F. ...GS, Suth Carol T
DANIEL K. INO Hawai
APLAI E. STEVNSN, IllinosBB AKODOeo
WENDELL H. FR, KenuckyHARSN.SCMTewexc
JOHN A. DURKIN, New Hampuhire JH .DNOTMsor
EDWARD ZORJNSKY, Nebraska
DONALD W. REL, JR., Michigan
Au~ny L. SRVIS, StfDietranChfCosl


'STEP-HEN A. MERLPoesonlSafMme

GERALD J. KOVACH ioiyStf one
WILLIAM C. GIBB, Miort tffCone



SUCMMITTE ON SCIENCE, TECHOLOYRADSPC


WEmNDELL H. FR, Kentucky RSNH CMTNwMxc

ERNEST IF. HOLLINS, South Carolina ROBETP RFIMcia
EDWARDf ZORINSKY, Nebak
DONALD W. RIEG~LE, Jk, Michigan1










LETROFTASMTA

Hon.~ HowmCANON
Chimn omte nCmece cecadTa!ottv

U S.-~i Seae ~~igtn ....
DERM.CAMN:Ia umtin eeiha oesgtrpr
,vth ubomite nSceceiecnloyiadSpcioi hergua
tino!eobnn N eerhan t plctos oehrwt






































































I








CONTENTSii~iii ii ii iiiii i iiiii
iiiiiii iii@ iii i@ iiiii
Findings ...................................................................................................................................................................................................vitiiiiii
-- - - - - - - -- - - - - - - -
iiiiiiiiiiiiiiiiiiiiiiii Iiri c i a
Actua an oenilBeeis -- ---- --i--------- -
Th Tchiuean tsSceniicSinfiane ----------
A p l ca i n o fiiii R e o m in n ........... ...................................... - - - - -
Productsi fro M iroor ansm ---- ---- ---- ---- ---- 6iiiliiii
Oth r A pliatins --- --- -- --- --- --- --- --- --- i



Se v c nd s r -- - - -- - -- - -- - -
Po en ia Ha a d - - -- - - - - -- - - - -
Geerl
E xp er m ent w it B co"l== "=ii==ii===i=ii==iiiiiiii iiiiiiii asii~=ii~iiii~ii the = == H ostii O rgai iii------ii-ii" ...8=iiiiiiiiiii
Creaton o a Noel Pthogeic E coli----------------
Trnfro eobnn N rmE i Ki1liiOhe
Organisms.... -- - - -- - - - - -- - 1
Deeomn fFrhe ekndE i Hostian
V e t r - - - - -- - - - - - - 1
U se ................ Ot e H o tV c o Sy t m -- - - - - - - i 11.....






E ffect of th iiiiuidei neiiiiii---iii---iiii--iii--ii--iiii----i14
























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SUDR -O IDIG N RCMENAIN
The sbcommttee inds hat te useof reombinnt WT tech
miqu israpil ineresin scintiic udertandng-f baic ioloi
y i ............................................................ ....
latreo dusan ndsrilezye, atetetmn, rduto
,o oo rps ndtetmn f eetcly eatddses& In h
absence......................................................... haz rd t e en fit t at hav b en and m a b
deivefro reeach ithrecmbian DN moecues'ju ify isiii~i
cotnainadspot yteFdrlGvrmen an h pmv
.. ..... ... ............ ... ... ..................... ..... ....... ......... ... ....... ..... .. .... .... ... . ...i i ,
A s.....r.................................t........ ff.................. diith e
....................................................r............... .......s u b -
-pet.t.............t.i.t.ons,.p.i.cipally.t.e.1.7......e.ines.g.vern-
in eerhspotdb h a ionllitu ofiiiiiiiiiiiiii
-centiiiiiiiiiiida aiindicitithatiiiiiiiiiiiiiperiieii e p i n
M R -approved hos............................. d no @ i gificn
rikst lbraor forest ubio th eniomn .....................






or possibly by amnsrtv cinudrteatoiyo eto 6





retappry vt o foWhsepesdapeeecefraseiireiltv


tamryoul renieus the auhrt oftePulcHatev
ice Act.iiii








suciher cased rcmiant DN hol e eiedabodysi





bot puicly ind purrn Ivaudlns I sas ssmdta
by the guidelnmest, whc rhbtcranprsmbydneos

tane p recri e yia nd bilgclcnanenxnaue o h
conducti~!i~ of p i s ib~iiiile ex iiiii ments...........ii...... The~i admi i .......... i n ........ =isi n g~ agenc should ii i ..




data Thee should', be. auhrt toexmt rm herqurmet

those! clse ofeximet thtae hw t oe osgnfcntrs
to health or:: th env iiiii ............... tow ietebno p riua x ei
metswhsereuls.r neesr to. ases the rifrcobnn
DNAresarh.,Inallof hee atins headmnisraor hold av
thei adv :iiii ofagopfqaiie sieist an....., ncudn
members! ofi the prsn HRcmiatDAMlcl rga
Aisory Comitee

The;i;;ii sucomite reomed tha intiuton be cetiie to con-
duct!!! ,~i l recomb~iit DNA!iii reerh Tecrifict solbecnitional
upon the appoiinmt an odc f insttioa lsftycm
m!i]lii~~iiiitte to~ii ap r v research projectsi~ certify~ laboratory facilities, pro-i =iiiiiiiiiiii!li iil~ iig =i iiiii i =:=''i;iig~ ="=igii~i" ii;"iiii== == ~i =Ii= ii iii 'iii=ig i'=i=iii iiii i =iiii i
....ie for...... th tr i i iii i of.... labo ator workers............ and researche.... ....tor
theiiiiiiiiii~ health ofprosexoeioreobnn DAmtraladke
such records an aesceot saedeeeesr. r n
format !i i ona iiiiiiiiiii!i !!ii=iiiiiiiiii l iii pu po es researchiiiiliii~il project shoul be~i re i te e in ad-i= i~iiiiiii .. .iiliii ii i
vac w h e admin == =iste i Federal agency= ; = === = =: ;. Bcusiiiiul b
inaprprat todiqulfyanetie ntiuto i te een fioa
=ion byasnl rafwrsaces teFdrlamnsrtrsol





~~~IX iiiii
thelii Feea an soudb epwre ow i Feel pemto
if ai Stateii or rocao y =iimen prsnscn iing resosinsppr
ofl strcte stadads Stte ndloaiie shud loepemttdt
takeii ote cin oasr i r iien ht h edrlstnad


are b ein giii ob served .i W h ile i th isiiiiiiiiii lim itediiiiii p ree m p tion cou ld n otiii b eii acco m-~~iiii~iiii~iiiiiiiiii~~i~ii~~~ii~ !!! ~~iiiiiiii~~iiiiiiiiiiiiiiii~iiiiii~~~ii iiiiiiiii~iiiiiiiiiii~iiiiiiiiiii~i~iiiiiiiiiiii
plished under section 361 of the Public H ealth Service A ct, the sub-i~ii~iiiiiiii~iiiiiiiiiiiii~iiiiiiiiiiiiiiiiiiiiiiii~iii~ 'ii
commtte's ecomenatin des ot ife ii fianlyfrmh
statusquo; fw comunitie have ioe ri remnt ecedi

the stndardsincorprated n the IH guielin. ilionsol

............................................i a t m en iii n or er to av
sufficient time to assess the effect of and need for Federal standards.i

Cr|we plcto
























A
















































































A






INTRODUCTION ............ iii~ iiii i .................,ii
Th biiy oreobieDN olcle f ifeetrai
hod teprms o mpran eeft, oh neletaladaeil
Thortialy itmyas raehzrst ua enso h ni
roet ritefrei npeical wy iheitariircises
Exchnge of eneic ateral mongorgniss ocur aturlly an
noilnese r thr dvre ffct hv benasocaedwih ecm
biat ouedi h eeac aoaoy.Nvrhlss aysin
titanlyerosbliv ha h ege f netint nd h
vagnitud of.the.hypothesized.risks.justify.restricting th seo
iiimb=HiiiiiiiiiiiiN i a t N Aiicniq es












experi,
begn
eviden
meant]


tion azi

1976, p


ceduire.

firms

cover
search
for vie
As t

over t.1

laborai
deeply
Much
veritiE
'COMMI
reerc
:and. ir







Zoghlative activity
1. James Watson, co-recipient of the Nobel prize for characterizing
the strtwture of the DNA molecule, first called the ittention of Con-
to. the likely development of new techniques In genetic research
a. 1971 hearing before the House Committee on. Science and
cology. Four years later the Health Subcommittee of 'the Senate
Committee on Human Resources held hearings on genetic engineer-
..During the past 3, years, nine eparate sets of hearings have been.
by committess of the House and Senate.
T6 Carter administration sent, draft legislation to Congress in,
emly 1977. Several. Senators and. House Members introduced their
o.wn bills, and it seemed.all but certain that Congress would eom--
plete adion on recombinant DNA legislation prior to the July 4
reces& A.The Human Resources Committee reported S. 1217, intro-
dueed by SenatorEdward Kennedy of Massachusetts, in'July 197T.-
In early August, Senator Gaylord Nelson of Wisconsin intro-
duced to S. 1217 fin arr-ndment in the nature of a substitute which-
approach contained in the legislation
followed the basic regulator
developed by Representative tul Rogers of Florida, chairman of thO7
Health and Environment Subcommittee of the House Committee on
InterstaU and Foreign Commerce. In September, Senator Adlai
Stevenson of ]Minois, chairman of the Subcommittee on Science, Tech-
noloy, and Spam, suggested in a Senate speech that the recent scien-
tific evelopmentsand the reassessments then being conducted by the
National Intitutes of Health and the Carter administration ma7de it
desirable to postpone final legislative action until 1978. In the mean-
time. Senator Harrison Schmitt of New Mexico, ranking minority
member, reqttpsted that the subcommittee hold hearings on the issue.
In these circumstances, the subcommittee conducted 3 days of
hearings on November 2, 8, and 10, 1977. Twenty-seven witnesses
(listed in the appendix) testified. Among the questions discussed at
these hearings were the following:
What are the actual -and potential benefits of recombinant DNA
research and technology I How long will it take for the potential
benefits to be realized 1
What hazards must be taken into account in devising regula-
tions for recombinant DNA research and technology? What has
scientific investigation disclosed concerning the hypothetical
risks that initially conimrned many scientists
What approwh should underlie regulation of recombinant
DNA research in the public and private sectors? Should there bo
common regulatory procedures covering both publicly funded and
privately funded research 1 Do the NIH guidelines provide a basis
for regulation of the private sector I
Do existing Federal statutes provide a basis for regulating re-
combinant DNA research and technology conducted with private
fundsl
Should there be uniform Aandards for rwarch in all localities
of the countrv 1 How can the concerns of State and local popula-
tions for public health and environmental protedion be accommo-
dated?








How can the Government insure the health.ad efrfth


theli wthut intuiguncssrlntefreo fsin
tifiinquiry?
Inolodydiely te beon oaeutestmn Fedra reuatrhef

mittee received extensive supplementary maeilfromitnese n
others. Federal agencies

controls. A list of those whosbte witte statmet a r
,sponses to the subcommittee's iqiisaefudi h pedx















I .= : ... . " iiAs



I~il=l!i i=I=l I. !T "h


A i i = = "" A =

. =, =.... .=I !.! .. A

= = =t " i .Ii ~ j =.I i" A
. . .... o . <.I ... @ . .. . . ...
" = = = = 1 = = = =+ "" = + .. .








M j


PART I-PRINCIPAL FINDINGS
AC=AL AWDPoTFmruL Brmmms
TM TECIffMQUM AND rrS SMNTMC SJGyMCANCE
In rewmbinant DNA research, specific sections of a DNA molecule
,40 extraieted from an organism or constructed biochemically and then
nwr* into another DNA sequence. The so-called recombinant DNA
-inolecaile is then introduced into a host organism where it can survive
-and replicate in cell division. This technique of artificial genetic ex-
ehanp may be performed with organisms that commonly exc ange
,DNA or with genetic material from two very dissimilar organisms,
such as a mammal and a bacterium.
The host organism used in the vast mai ority of experiments is a
.strain of the common bacterium EscheiAia coli. In addition to its
mxtgle large chromosome containing DNA, E. coli has one or more
bidependently replicating smaller loopsof DNA known as plasmids.
Me plasmids are relatively easily isolated from the bacteria and
broken open by restriction enzymes. The foreign DNA is linked to the
plasmid DNA and its circular form restored. The plasmid "vector"
is then returned to the whole cell bacterium where it can resume
replicAtionl duplicating not only the native DNA sequence but also
the foreign one. If, in addition, the foreign DNA molecule carries
-wAh it the mechanism which regulates its expression, it may produce
the protein or other chemical for which it codes.
The development of this technique is -widely regarded as a major
-advance in the biological sciences, both as a means of studying basic
biological phenomena and as a technology with numerous becieficial
applications. In his testimony to the subcommittee Phili Handler,
Prvsident of the National Academy of Sciences, describ DNA re-
eombination as a research tool of "extraordinary power" for under-
standing the structure and functioning of the genetic apparatus. He
reNrred to a recent report, "The Risks and Benefits of, Rliombinant
DMA Research Performed Under the NIH Gui -I- (November 1,
.IM), by a panel convened by the National Research Council of the
Academy, which cited work using preselected genes of various animaJ
Including fruit fties, frogs, and sea urchins. The report statAm that
"the distribution of likely regulatory sequences Mong cellular chromo-
somes has been mapped, using cloned recombinant DNA segmentp,
-and has surgested an unexpected mobility of genes." Similar experi-
ments 'are bimig done with plants. These and other developments am
contributing to an understanding of the general principles of chromo-
somal orgaLization, genetic regulation, and inheritance -as well as
genetic abnormaJities.
Awovdm*g to Stanford Professor Stanley Cohen, in a letter to the
subcommittee, more than 250 scientific investigations involving recom-








bim


terli




i~i~ 7
i k a n h i l u ib ito r to th e p r o d u c tio n o f g lu e g o n k n d in su lin a n d to the
pitutalTglanA reeaseof hrmons reulatng bdy gowth

Ni-is o te nierit 6 Aabmanoedin hs esi'
thatinodficaion f :te imroorfamm o tht gee exresson ocur
ldui|iiiihirmonesicommercially.
Seewd ill beto prvent te micoorgansm.frm.degrding.rotein.whic
&I*...................................................................n....t
datepry Tbfrd ill be o allowthelmirobialiostitoiecreteiheihormneiint
-th catwemedum o fciitae Is rcovryfre fom actria cotamnaton
T~urO4in addtion t the o essetialimdificaionsifitheiicrobilihostvecto
sysb4 i wold e hghl degrale o hve he icrorgnis adpte fo us
In ermntal~ tehnoogyan ths gowon n iexpnsve edim ihiiiii
maxlum, ield of ormoe an miimumyiels ofmicrbialcellmas
'Xavrth.. ftoaldCap, pesientof CtusCor. o Ca ifr iiii
suggetpidthatsome onmeicalproduts culd eiavalabl iniiyea
o r t w o....i....................d.........................riiiiiiiii
........................................i iiii
Mm: mmulatie use of rcombiant DAiincudeiteirelas iio
Ahe.modfied hot cel ito te eviromen forsom, spcifcipupos
*a& oth coverson f ogani maeril insewge reatent th oi
Akt* o~perolum.spilsor mprvemnt n't ntroen-iigiii
.7o plnts Iallof hee ea~pestheintnton oul b
to eft~s th recmbiant rgaismsin natralenvionm n
fororgniss wichperormthesam finctonsbutles
eficenl. ltrntveyiths ee sgesedthta odfid-vctr

probbly vius, oulae ued t inect lant oranimls n i
to nftaftthe1:0otoynteti caabiity oflans estoy iiiiiiiii
pestsiiiiiiiii oriiiiproduceiii= somioheiiiiiiigeetiiiiiiiiiemot~r
miiiiiiiiimiiiiiiiiaiiiiiiiiiijeiiiiiiiiiiiiimaiiieiiiiiiiiaiiiiii
,C~aleo oretngdsas-asiggnei efcs







e viionment; c t s c
manipulatio fhmnbigs n rta h reec.'wt
natural evolutoaypoessmyd naclbeeooia aae

of basicscavaustameipulcdsusobuarntyt
capable ofbeingreovd




bi ronbi e s ndi e ntfcassmns-f h ik fecm

w oete hr sayeiec edn rdnet speculatioons about






K arieddt insrusofaporaebooiaanphiclo-
seins ofibiil m ta
Most speculations of rsk cite the lack of kowledge about possible





change in ucin ftereobndDN oeul.I sugse
tha.th joinin of a foreign gone with other genes of an organism orii~iii~i ii
vector or the chaxacteristicsi~i~~~ii~ i!!i!!!ii~~ii! ~~ii!ii~iiiiiiii of th ne gen itel mightiiii produce. some~i, ii ~ii
unexpectediii~i!iiii advers aciiyi h, e olevrnmn.I o,
escape. of the organism or the. accidental. transfer --of- the recohi ina t
D N A~ii m olecu lei~~~~iiii~~~~iii i!ii !! ~~iiii toi!i~ii an oth erii~iiiiiii~~~iiii iii! or an s m ig htii~i~~~iii~iii~ii cau seii~ii~~ii d iseaseiii!iiiii~~!! ini~ th e.i!iiiiiii~~i labora-iii~iiiiii~~iii~ii~~iii~i~i~~!i~~~i~ii~i "Hiiiiiiiiiiiiiii~i ~~iii~~i~i~~~ii i" ''..

to ryiiii ,,il~ i'iiii .................. or .............. b e.............i n g s,~i ani i m als .. ........ p la ti n th e............
eironment.i




EXEIMNS IH 4E.Cld -12AST HS OGWIS

The~ii~ iniahotclemlydicurnDN reobn tr-







An turn to another strain of E. coli or other organism if the K-12
c ll were. awidentially introduced into the intestinal tract? Could
some DNA recombinant manipulation produce novel E. coli cells
-which -would be pathogenic or ecologically disruptive? Could genes
from highef organisms be transferred to any of the prokaryotic. cells
(cellsInthout a typical nucleus, such as E. coli or other bacteria or
--algae) and be expressed in such a way as to cause harm? Is it possible
to, construct a host cell for reeopabit*nt DNA research which would
-be so fastidious in its growth requirements that it could not grow
outside the lvj oratory I
-civation 61 a novel pathogenic E. coli.
The Academy panel's conclusions, while not absolute, indicate a
-negligible risk of creating a novel pathogenic E. coli in experiments
with the K-12 strain host cell and special variants developed specif-
'icaIly for recombinant DNA work. The K-12 strain lacks the genetic
--cApability to the-size an important substance involved in the patho-
geniity of ot er strains of E. eoli. The K-12 strain cannot establish
'itself as a resident organism in the human intestine and does not mul-
Aiply in that environment. K-12 is therefore a "safe" research host
-cell without any modification to reduce further its survival
-capabilities.
Ile. panel based these judgments in -Dart on the conclusions of a
meeting of microbiologists and epidemiologists at Falmouth. Mass.,
m June 1977.11 The conference reviewed a variety of experimental
ifindings including the following:
E. coli K-12 cannot be converted into an epidemic pathogen by
1aborstory manipulations with DNA inserts.
.. Deliberate attempts to induce virulence in K-12 by inserting
genes known to regulate virulen ce factors in other wila strains of
E. coli failed to produce a fully pathogenic strain of K-12. These
experiments used standard genetic methods rather than DNA
.recombinant techniques.
K-12 deliberately fed to human volunteers soon disappears
f:r6m. the human i&estine; in one case- limited colonization oc-
curred but: did not persist beyond- 6 days. The human body defense
mechanisms are very effi)ctWe, against K-12; the strain is easily
44s"6d'ky'normal- chemical iabtivities in the intestine.
A -delibeiate attempt to produce a h brid of K-12 and Shigella
flexner4 an organism which can pro uce infection in the bowel,
resulted in a hybrid that picked up genes from Shilgella but failed
to produce any disease and quickly disappeared from. the intestines
of volunteers who in gested it.
The special nontransmissible Plasmids used in recombinant
DNA work with, K-12 cannot be spmad to other host bacteria
within the human intestine.
.,.An attempt to prqd ce.& virulent K-12 by transfer of plasmids
from ikaturally occurrmg E. coU strains was unsuccessful.
Taken together,'.. them resOtS suggest that IK-12, cannot be made
pathogenic by processres which convert other vaxieties of E. coh.
Tbe, pzoieerofi; 9f th;pl r n!erence 4Lr& published in the Jaw xal of Difectime
V4eus", voL : SW7, ay 19 p! S_,R4



















other hf drectmbtranfo rto E woi K2to other n ra
Ai~lili few sc ien i ............ tha while- K -2isl sInie o e








fu isitercionwho thrE o tan cud Lehzrs
.......... ofii infect!iion fromi E.ili strin ote thnK-2ihi nces
pli ds by E. cotiiiiilii i~~i bacteriii n the, intsinei n .................. thatthe

DN mlcue t wl stanfE cianmihidueaew









frof athgnct.H rudta h vdnesmaie r
signiAcantdemeotand exmnfa the Famut oneenei
Evufien tocnld htueo 2elmntsayptnildn
ger f ecvoit mleul xcane
ropio t4eFlot ofrnepin oteeiec htK
amg iLaboaltbo tyI; baged irsearchers s t
Die l7, pit 3 7 be di o im

-experiiet adeuael padres th sibiit f eernse


in toii~ determiiiii~in thelilihood- of such transfes. Oliver Smithies o
thUivity of.. Wisnin refrre i i tetmn oahnupb
lished i paper... 2= rering that. in 2yir prid fioniorngth
fee oflbrtrywresenae nnorcmian N e
serh noi K1 batia or~i K-1 psidwt ulil ru eit


no ppa, r i sii ittle if an rii of geetasfrfo K1 l
id ircinatDAwr.Tiitd i ieyrgre sa
iificatdmntaino h sft fteK1 ot
Deeomn ffrhrekndE oih stanveor
Even though th ilWidec hw nral -2t ea
v ery-iiiiiiii~iii~~ii!~ d eecti v e o r a i m ev eniiii~ m o reiiiii en fe b le v a ria n tsiiiii~iiii~!! h a veii =i~=iiii~iiiiiiiiii b eenii d e-iiiiiiiii, ii= iiiiiiiii== ii ii =iii=""=iiiiii=iiii=iiiiiiiil=iiiiiii= ii ii==ii..
velope to preventiiili colonizatli i o andii~iiiiiiiiiiiiiiiiiiiuiiii~~ trii iiiii iiliiae ofi!! recmi nan D NAiiiiiiiiili.. iiii
th v en t ofiiii acc= i d en tali ................ o fiii= the.............. org anii .................................i sm ~~ ; ....... R oy C u t s ......
Un;i versi=i i t of Alabam descrii="='i ="i=~i= "ii i ==== !!~! i i =' i bed' h"" ....== is"",'i... su cesi pr d cn additional==
inu i onai; = changesii =" ""ini=iii Kii2 wiiiih greatl ilit thei abilityii of tihiiiii
2 erohel. usadi. .Rihmn, 'ib'ec ofii~ Pls i o .-oik neto
A mong ===i~iiiiiiii~iiiiiiiii~iiiiii~iiiiiiL r t r Personneli Engage inii iiiiiaii Rese rch, Ge e o.2, N 5 6
December 1977,iipp. 323-327








IK~~~~rk~ togoinannaoao niomn.Tersli mu-iii
tant named W 1776, met the criteria for EK2 containment developed


-by he NH Reombiant dvisry ommitee nd ws aproveifo
-expeimentl us by te iiiiiir
Olive, Smthie, -amembr ofthe rcentAcadmy pneldiscunte

-MW Vo~i blity.of.rik.with.th st @ orgai cosrceyCri
-and is Coleagus. Smthiessaidinlhistestiony:

th e................le.................... su v v n in. the iii fecesiiiiii
or::f th recmbinnt DA plsmidbein trasfereditisom
othe baceriabecmes ess hanone hanc per100000 abortor
workrs, orkig fo 10,00 yarswithut secia phyicalpre
cautons.(Wit th appicaton o) pysicl prcautons
the rsk i no onge worh cosideing.

Several ssetialy nntrnsfeabl plsmid hae aso ben eveope
forae, a vecorswithK-12Chi 776
Curtss nd ther threfre dsagee ith.thesugestin tat rei
-erece e gien r exerientaionrestictd touseof hst ellstha
do mot ormlly nhait umanbeigs.Not nlyaxethe eneic har
-actristcs:of B coi K-2 wll kown ut lso ubsantil eideneio
its iet~is eginin to ccuulat. Areqiremnt o us anthe
lwd:!M woud imederesarchandraie grate unertiiii
4boutpotetial isks




UM O OTHR HO-VECOR SSTEX
T h e.......................................................... i iii








12



resnt Ienme fahs f gfnssepoe nDArcm


inatrsac.n eeomn svr ieyt nrae
qT1RCOCRT
Th oueofrcmiamaeilpouewlllsicrsef
conoc Alapiainoth ehnii eimfesbeThek m-
eneofte imeia an chmclidsre sget htlre
scl prdcto of reo bnn oraim wil be reuie in ore to +++ +++ +++
obanueu rdcsi ufcetqatt o aktn.Sm e
searcher inis thtseilpoeue n fclte ol rvn s
caeo hs raim rma ndsra aoaoy u h I
Reominn Adisr Comte ha asue that probailit of es-
cap fro cotimn barir oriaiyinrae ihcl.Te
co mte rec mmede an NEE inlu e in+ its+ guielne a+++ pro- + +++ +,:++ +++++ ++%+
duto li i on reo biat know to mak harmfu prdut of' +++++ ..++ +++++.. + ++: + ..+ +
10 lies whc sgnrlyaeutefreprmna ok
Th Emi isabtay oeefrteeaen'a+ ltoso h
coreai bewe th voueo raim n h rbblt ht
soeo hs raim iletrteevnet Invsiain of,'p+
........... rik associate with reo bnn DNA+ have+ yet to+ address- +
thi question+. + + ++
The+ deiert reeaeofareobiat olcle hihiscntm
plte fo vaiu fuur aplcton...e ehoogi ~ as
fo ocr.Atog vial aaidct htteacdna s
cape of+ K-1 would pose+ minma risk to: helho hevrnet
its behvio in a+ varet of natra cicusane has: no ben




i13
ux xT = = Az 1U u AT oN or icsEA HHH cxt
ORIGM! ANDPRVIION O TE IH UIELNE
Reseirc with ecombiant DN molecles ha been ubjectto vol
u n a y o n o u t e t i t o s a m s r m i .............................................................
nuL~y, 6,-yers -.ago...............in..he:..173.Gordon. nfere!!te !o
Nucleic ~ ~ ~ ~ ~ ~ ~ ~ ~ ... Ais asd h psiilt taiom xprmnt oudb
hazrdos nd rgd te atina Acdey o S ie to crate
stu d y......o..........e.c...m.n.d..u....e...ne.s..r................................o n .
untarily"defer" ertainieperimeniitlatiiiiiiiiindrectly, ncourag
t h e............e..a.............nt.i.b..io t..i.c.... .............................................................nd............e r -c a u s ingiiiiiiiii
orohraia iues te eomnainso h omte e
to......t..h............................ th eiiiiiiiilliiiiiliiiiiiiii~i~ N I R e o m in n D N Aiiiiiiiiiiiiiroiiiiii A d -
visoy Comitte in197 andto a intrnaiona meeing f s ienit
and thes atAsiomar Caif.,in ebrury 975
The onsesusat Ailomr, as tat mst f th conempatedwor

with r~ainbnah DN shold roced bt-tat pecationrV eas
tire should usd tominmizethespred o artfical rcom it
DNA'. i huan opuatios o oter onlboraoryenvronent
Fron th pubicaion f te Aslomr reortin My 175 utilJun







14
environment. These measures of "ph~ysical conta iment" are grouped
into four categories, P1, P2, P3, and P4, 'each level more stringent
than the one preceding to correspond to the presumed potential risks
of various experiments. Fifth, researchers must use biologically weak-
ened, vectors and host organisms that are unlikely to survive in a m-
laboratory environment or exchange DNA with. other orgnims
These materials are also graded, EK1, EK2, and EK3, top~vd
"biological containment" commensurate with the potential is of
harm. Before they can be used in recombinant experiments, EK2 nd
EK3 host-vector systems: must undergo extensive testing, rvew by
the Recombinant Advisory Committee, and certification by theDrc
tor of NJH.Thus, permitted experiments are assigned levels-of physi
cal and biological containment which are to a degree interch angabe
an increase in 'biological containment may permit a lowering ofphs
ical containment requirements.

F=T OF =HP GUIDB"qES
According to testimony before the subcommittee, these mesues
taken together, provide a high degree of protecton of pulic eat
and the environment. Philip Handler stated, the conclusion of te
National Academy Panel on Risks and Benefits of Recombinn DN
Research, whose members included authorities in molecular biology
genetics, infectious diseases, and epidemiology. He quoted:
Currently available evidence leads us to conclude that the many beiient of
recombinant DJNA research and technology can be achieved with negligbe risks
to the -biosphere when the work is carried out within the &IH guidelines.,
IDespite minor reservations about the permissiveness of the sad
ards, Bruce Levin of the University of Massachusetts characterized
their approach to the unknown risks of recombinant DNA as properly
-one of "extreme prudence." Paul Berg, Frank Young, RoyCuts
and others generally agreed with this assessment.
In the past, physical containment procedures similar to those re
quired by the NIH guidelines appear to have been effective in pro-.
venting infections from human pathogens used in research.~ In other
public testimony, the Director of the National Cancer Institute
Office of Research Safety described the experience with high con
tainment at the former biological warfare laboratory at Fort D~etrick,
Md. During a 10-year period ending ha December 1969, only one Jsbo-
ratory-acquired infection occurred as a result of an accidental glove
puncture. The environmental impact, statement accompanying the
guidelines included an analysis of laboratory-acquired infections data
from the Center for Disease Control, the National Animal Diease
Center, and the National Institutes of Health as well as Fort Detrick;
it found no case where a disease was transmitted from an infeoctedl
laboratory worker to another person. The EIS noted that only eight
such cases have been documented for other American and foreign
laboratories. In short, scientific research with pathogens under strin-
gent containment appears to have an excellent safety record.
Roy Curtiss and others who have attempted to calculate the risks.of
survival and reproduction of a wea~kenued test Oranism~ rvoo
should physical containment fail believe that these risks am exceed-





m1
iSm H A lt h o u g h t h e p d ba oilit y o f s u r v iv a l is g r e a t e r a t l o w er
of bi ogial cn taiHHHH HHHn meHHHHHHn t tHh e xeiet eritda hs

lb"A.. eneall inolv oranim kownto xchngegentic iiiiii-
ipatonbynatral process

On tb ther hnd, neiher thicontaimentlmasuresioritheassess
),0At~o thirefetvees reifalbl. nth piio f oata
ing evn smllnumer f cciens mghtdoir abe hrmi aiiiiii
delterouscobintio o gees houd stablih ~intheen iiiiiiiiii
wnLHeelevs hatmoitrig f lboatrywoker' eathan
-n ^ f edca rcodshae ee iadqute I te bsnc
-ta i is nt PO~ible-to id thieffetiveissio

-Of line.health..a 7 .. g
physial cntaimentmethds wich re, n an evetietireyide
pendnt uon te trini

& and ehavir of lboratiiiperonnel
Othes hae ponte out at te cnduc of eserch ithimo i
jA tho xperimntsifo
ens ay b quie diferet frmthicondctio
...hi6no azads av -ben emostrted Athu Scwarz, Uiiiii
,.,.versiy of Michgan matheatician, uestionedtieicalcuationsio
potetialrisk in ecominan DNAreserch.He satedin istti
I x ol y o he ub om it ee ha i h s sti at onth meho s se b






















=16
Sevic adth (4 eac prlfrte.Nwan oeineiu knso
eaxperiets aepooe. n alBr gedta reau

atin i nt sffciet. n iewoftlihoodta osdrbeucr
tainywl eandatiualmbu el evlpdtenqe n
hot-etosytms tee s radsuprtfo oninig o rhii
ceti1eobnn1-N xeiet n onrlohrpoie

thatther is o ritnt orlxo eoersitoso eerhta


bectoes jusfed oalvlta orsod ihteucrany





Iii iiiiiiiiiiii~ iiiiiiiiiiii iiiiiiiiiiiiiii iiiiiiiiiiiiiiiiiiii


v~~~~~~~~ter~Iiiiiiii .......~nco py n wt h g ieies o ad a eo
10SUMCorp staed "e wat tobe teate bot in he letters wll a
the siritlike ve~y ele intermsof tese gidelnes.
The efectvenes ofthe NH gudelies des no depnd uon rason
abl sanars loe.Italo eqire pocduestoreie ad nfrc
',6inliace Itcanotbeargedtht te uidlies remerlyad

v~~~~~aory.~~~~.... Thictbri97inirnena mpc saemn o he17
muidein~es staes tat "Nncomlianc wit the uideinesiill esul
5 'termnationof funing ofresearhigrans andiontracs." Ye

,,stali clarl th reponibiitis o intittio s, nsttuton liii-iiii
hazars comittes andinvesigatrs, ad by ieiasenceofian men
tiollof prcedurs to nvestgate nd corectiiolatons.iileiuiouit
dl mot rseaches hve bsevedtheguielies onsienioulyiii
IS euall cler tht oters avesubsitutd thir on jugmensio
safety for those.of....

Thee cncusinsresltfro te sbcmmie' inesigaion ofiiiiiii
An acknowledged iolation lastiyeribyiresearchersatithe Universit

"OfCaifoni a Sa Fancsc Mdicl cholreortd riinallyiiiiiii

- in he Setembr 30,1977 issu of Sienc.........he.cae .in
-vovedtheunathoize us ofan K2 lasi vcto wih E coiiii
.X 1776in a P3experimnt to cone theratiinslin gen..T.e.vct.r.i
-question,~~~~~~ ~ ~ ~~~ pB32 wssbmteit I frcrtfctini!Dcm
ber 976 aproxiatey 6monhs aterpubicaton f te g ideie
I nth F de alRe ite heex er met sngpB 32 w s on uce





18





19

-the absence d this period of the prindpal investigator
on the insulin projectMoward Goodman Boyer was designated
I . I 1131A. If
to: NIH as the acting princapa inv i Yator. Goodman also asked
Brian.McCarthy, another member of tfe decrtment, to be avail
AW to advise the investigators in his I& ratory. Boyer and
11fiCarthy also shared responsibility for supervising the newly
constructed P3 facility. Both knew that pBR322 had not been
certified but claim they were unaware of its use by two post-
gx Omtoral fellows conducting the experiment, Axel Ullrich and
Jonathan Shine.
Shortly after the first of March, Goodman and Rutter dis-
covered that PBR322 had not been certified. They attempted to
ascertain from NIH whether certification was imminen Finding
that there would be a farther del y, Rutter called the NTIH Deputy
Director for Science, Dewitt Stettin, between March 16 and
Numh 19. to seek his advice about the continuing use of the vector.
Butter was advised to destroy the host organism5; at that point
he and Goodman decided to terminate the experiment. The
Deputy Director did not inform the NIH Office of Recombinant
IWA Activities (ORDA) or other officials of the calL
In late May a member of the Rutter laboratory staff informed
David Martin, chairman of the UCSF biohazards committee, of
the pBR322 incident. After making a personal inquiry, Martin
told a meeting of the committee on June 3 that researchers had
used a vector on the advice of NIH officials who predicted its
"imminent" certification. When certification was not forthcom-
'the researchers had to destroy their work "to avoid non-
ing,
0 ompliance with the director's wishes, although consistent With
the ouidelines." The committee approved a letter of complaint.
to MM that referred to the delay in certifying pBR322 but not
Wits use. It was not until September that the full committee
learned of the violation'.
Apart f"m Rutter's call. to the Deputy Director in March, no
one at "UCSF reported the'incident to NIH; officiaJs of ORDA
and the Office of the Director did not learn about it until late
mmer when the Science reporter inquired. Even then, no in-
vestigation Was made; rather, ORDA requested a written report
from the now chairman of the biohazards committee,. James
Cleaver, for the p Of auswerlngr further public inquiries
-to NIH. Although e report, dated October 2.5, indicate that
Am *mperiment continued for seve'rul weeks after the investigators
crimovrered that the vector was not certified and that neither the
'biosafety committee nor NIH was fully apprised of the incident,
NIH took no farther action until prompted by the subcommit-
tee's investigation. On December 1, ORDA asked for a supple-
mentary written report from the bioliazards, committee chairman.
1hoUCSF violation occurred shortly after NIH issued procedural
imikructions for implementing the guidelines and coincided with the
formulation of test criteria for host-vector systems. It resulted in
part from confusion about the NIH approval yroce & Witnesses
stated that NIH has since hnproved its publication of certification
actions and clarified the roles of the RAC and the: Director. Accord-






20

ing to William Rutter, the system is now tighter and mono bsiness-
like. Be that as it may, the researchers who conducted the experi-
mients neglected to confirm the rumor of pBR322 approval anid theui
delayed correcting their error in the hope that the obvious remey,
would not be necessary. The acting principal investigator, the bio--
hazards committee, another permanent members of the department
exercised so little supervision that they did not discover the use~ of the-
uncertified vector by their colleagues. Director Fredrickson lefV theo.
subcommittee with no doubt that this lack of action was contar to
the intent of the NIH guidelines.
The guidelines themselves, however, are deficient. They required
grantees to report accidental equipment failures and problems of
operation and implementation of safety procedures but make no. pro-
vision for reporting or investigating violations. Only an unusual set
of circumstances, not monitoring by the institutional biohazards
committee or NIH, brought the incident to light after the resercers
had decided to keep it to themselves. It is not at all clear, as Fared-
rickson maintained, that the institutional committee is the proper,
body to investigate allegations of a violation. In the absence of any
standard procedure, both the local committee and the Office of Re-
combinant DNA activities failed to conduct -a thorough inqu iry an&t
relied instead on statements by the principals. Finally, the episode
demonstrates the inadequacy of the guidelines' enforcement nmech-,
anisms; NIH has little recourse other than to withdraw the grant1 of
the principal investigator, who seemingly bears less responsibility
in this matter than other members of the department and the bio--
hazards committee.
Appropriate' legislation and reasonable regulations -can formallyT
correct these deficiencies but will not have universal acceptance. Not.
the least disturbing testimony in the affair was William Rutter's ra--
tionale for secrecy-the researchers' presumption of safety and fear-
of exacerbating public controversy. First, he said, "the Recombinant
DNA Committee had voted to approve the plasmid as an EK2 vec-
tor. The DNA insert was placed in a region of the plasniid such that~
it was unlikely it could be~ read or expressd. The experiment iia&.
been carried out with no ill effect." Second, an inflamedd social and-
political climate ** -existed with respect to recombinant DN{A
technology. ** The press, among others, had sometimes fanned-
the flames of controversy. * Repressive and, punitive legislation
was being considered." This assumption of superior ju dgnment_,
threatens not only regulation but also productive scientific inquiry...
If even a few scientists ignore the common gr .ound rules of researchi,.
they undermine the basis of healthy scientific competition. If. the~y
are discovered, they undermine public confidenc e in their enterprise..
It is clearly in the interest of the scientific comnmunity- to cultivated
willingness to comply with the guidelines. No enforcement systemzi
can ever fully substitute for a spirit of good faith observance amng-
investigators.
Regulation of commercial applications
As previously mentioned, the subcommittee, heard several predic--
tions that practical commercial applications of, recombinant. DNA.L
technology will be feasible within a few years, much earlier thaw,.





was~ ~ ~ previiiiiiliiiiiiiiiiiiiii asu e.T escesi fteC lfriaiv.in si
clonin th e rat i su lin g en e andi inii d eiivieilioiiiip ingiiiiiiiiii iiiiiiiiiiiiiiiiiiiiiii iiiiiiiiiiiiii iiiiii iiiiiiiii sy niiiiiiitiiiiiiiiiiiiiiiiii iiiiiiiiiiniiiiiiiif iiiiiiii
th e............................................................. th h o rm o n e siiiiiiii i t to t e p s i iit
ofpouigavreyofhroe n nutia ezmesi ag
culure o reominat NA rgniss.Preumbly te ogaimsiiiiii
wol ecnandadeetal etoea hyaei h e
serhlbrtr;btthi ag ouewudinces thiei
hoofwreexoueadecpofteognimf oth
faility
Mor spcltv ussatal otmlt h eieaerlaeo


th moiidhs elit h niomn o oeseii ups
suhaste ovesono ogni atrali swgeteamnt|h
oxdain fperlemspllorhnpoemn i tenirge-ixn
aabltyofpans.Aid fo teposil hzad o teorrnis
itsef, tese ses ay ave dvere iniret effect Plats iu
perir ntroen-fxin chractrisicsmigh diplae otersor alu
ableresurce bedestoye. Alerntivey, herehasbeenmeniono
a moifid vctor prbaby aviru, t inectplans o detro
= pss Inteecss niomnaixoue o xmlfo
spamwudb ifcl ocnro.Teueo oiidvco o













PART IT-RECOMMENDATIONS
RECO.51MENDATIONS FOR IZEGULATIOX OF PiESEARCH
LEGISLATIVE AUTHOR=
In:response to the concern that some recombinant D-NA research
was unregulated, the Secretary of HEW convened an interagency coni-
mittee in the fall of 1976 under the chairmanship of Director Fredrick
scpL: The committee included representatives of the Federal agencies
*ad departments sponsoring and conducting recombinant DNA re-
m4rch. and those having regulatory authority that might be applicable
in this area. Its first task was to consider whether the extension of
the.guidelines beyond NIH to the public and private sectors could be
acmniplished under existing statutory authority or whether new legis-
latw*n:w'as required. Having reviewed the relevant statutes, the Inter-
agancy: Committee reported in March 1977 its conclusion that "no
single lft_1 authority or combination of authorities currently exists
that would. dearly reach all research and other uses of recombinant
DN.A techniques and meet all the requirements." Dr. Gilbert Omenn,
Assistant Director of the Office of Science and TechnologgT Policy,
reiterated. this position in his testimony to the subcommittee on
November 8;. an4 it was generally supported by _11.1areia Cleveland,
attorney for the Natural Resources Defense Council, in a December
memorandum requested by, the chairman of the subcommittee.
The Interagency Cominittee rejected use of the Occupational Safety
and Health. Act of 1970, the Toxic Substances Control Act, the
Hazardous Materials Transportation Act, the authorities of the Food
and Drug Administration and the Center for Disease Control and
several more specialized statutes primarily on the grounds that they
could not be extended to cover all performers or all aspects of research
with recombinant DNA. For example, the Occupational Safety and
Health Act, defines "employer" to exclude States and their political
subdivisions unless the OSHA standards are voluntarily adopted.
Twenty-six States have not done so and thus their public universities
would not be subject to Federal regulation. -Section 5. of the Toxic
Substances Act exempts from the requirement of registration with
EPA those chemical substanm used in small quantities for the pur-
p- erim on or an& aza ous a-
on ct would, not apply to the handling of recom
binant DNA materials in the laboratory. The licensing authority
444eCenter for'Disease Control under section 353 of the Public
Health. Service Act is limited to clinical laboratories. F -DA's author-
ities:are. -generally interpreted to reach the manufacture only of com-,
mercial products.
The Interagency Committee found no such obvious deficiencies in
seption 361 the Public Health Service Act, on which the Environ-

23-890-TS--3








mental Defense Fund relied in its p(
This section authorizes the Surgeoi
the Secretar~y, to "make and enforc
ment are n to prevent the inti
of communicable dis from fc
States orfrmoeSaetonth.
fumigation, disinfection, sanitation
carry out such tions.
Section 368 provides for a fine ol
more than 1 year, or both, or
section 361. The ]ntergncy Coi




iii i i :!ii 3 KA W
rml wdaimlpoucs helih n e


lak~~~w:0.... iiimeniiiiiiiiiiiiiiccord ngito P ress
4 9ck pefeene or reena~nofth ocurene o ay i.........

T~the tha conrol f th sprad o infetion" Intheabsece o con
slu.4Mvideac to th country, te possbilitythat rcombinnt DN
xespwmh n nonhuan anima oriplatimateralsicouliresultinihuma
mlectionwould jutify comrehensiviregulatoniofithiresearc
ma~rthi athoty.For hes reaons th Offce f Scenc an
TW~mlog NEUremvesthe ptin o recmmedin tha reui
64as~~~~~~ ~ ~ ~ ~ beisueiiiesetii 36 i lgilaio i lngdeayd
Viewof te aue~nntte

I Te ubcmmtte blieestht te edealGovrnentshul
lely o fun egal athoriy in rgulatngiallrecominant NA ire
lk~h"Prdew f it locle r sorcesof inanial upprL Apro
vaiumtaY compliance yiand mnitorigiofiinustria
ie~om 4ivtie i msffilen. hatverfor sch prgren ightiiiii
talie it ouldleav undar te sttus f te supiiiiiiiiiarc
in ufl'erstie Moeove, bcaue i wold equie te cnset O al
to :!; tntsthem i no asuramithatitiwouliiiiiiii ii ililii
V*VI & pivae scto.. t wuldnotaffrd ~os sujft toiii
A* to- t*Ocei te ratin o suseuet rviio ofth g i-iii~iiiii
I~e mk if trecivesanit-ons or ioltiowwoud uderi
1"0& '16nfdenu thatthe iidelnes ere bing.obsered. il,
thd epatmet o Commce ofexprtie w ii
theDeprtmnt f Halt, Bucaion &a Wefar an
Mwoifl be wmefuliiiiunneissiry









iii ii iii~ iiiiiii ' '' 26 ''
mesrsaotdi ueosohrcutis h ute osblt
tl suchiiiii aiidiseaseiiwouldbe resistant toi present methods ofiii Proven-l
iio and tramni nacsteraonbeeso hs esrs
Seta 6 osrfrol ocmmncbedsae fetn u
.....en. Peul, there are or will be recombinant DN4ex
peiet htcudpsears fijr oplns nmlo h
in-rn tbtnto hmnifcto.I eesrhwvr h
Proeci o ofi anmi n lat ih e civdi
copeato wit thiereayoiArcltr snghsauhrt
u n d er' .........................................................., ...............



Federal agi es to protect. the.en.iro.met.in.all.m..........
whetherii ori not .............. author== '===iii~i :::::::::::::::::::::::: =iing statute... specifically providers for envi-.
ronmental prtion.iiiiiii
Of grae iocr ote ucmitei hthra fetv n
aprpit reultrysstm old- etbihdude ein31
=ilts us topoibitcranknsoscetfceprmtpecib
s t n a d ......................... t h e::: := c o n d u c t..................................................................... r e -=
!isteriiii~i u~iii!===ii '=====i research projects wouldiiiiiiii~ii~ ; i i ndeed be unprecedented. The act d== ii~i =i
n i mi t the.......o.w...r....o.....S.t...t...........................................................p o se sta vtd-i"'' ..
ard at vracwitthFeeastnad.Tecinl eats
inscin36 ol eipriatiiii@orte otseiu
wilu iaion of te rgultios tat esut i ham.evetheess
the agenc isteaporaeoeadtedeeainoauhiy
broad.iiiii Thi ertr rSrenGnrlwudntb nubrdb






27

Wdelines)'of the NIH guidelines does not resolve a variety of con-
troiersial and technical legislative issues. How should ree6nibinant;
NA research activities be- defined? Should regdlation be temporary
JAJbe- expectation that further research will demonstrate thesafety
of, &B rwombinant DNA experimentation or that public concern will
d!Wniab I Should legi0ation. simply extend the Rresent NIH stand-
o0de W no-NIH-funded research projects or require, new regulations
to, bo im 1, Are the July 1976 guidelines or the ehanges recommended
to the Director of NIH hy the Recombinant Advisory Comm ittee the
appropriate basis of regulation I What provisions should be made for
future changes in the standards to reflect new scientific evidence of
great r*r reduced risk? Should legislation exempt from the standards
experiments that are proven to be safe or to duplicate DNA exchancres
that occur naturally?
Sbvlrtil of these questions reflect the concern of the scieniffic com-
iftuAity that needless restrictions may be institut4d and thereafter per-
#htttated. For example, there have been various#proposals to appoint.
t oonmiittet of experts to st d the evidence reltkting to the hazards
.athibuted to recorribinant DN ort its findin-as to
7 research and to re
C6t,4r", and the executive branch within a specifiZ time. Propo nts
.oft 1ftd J mission appear to assume that Turdler scientific investi-
,d Adbhwillshbw that most ififot all recombinant DNA experiments
p 6 0# negligible risks to health and the environment On this assump-
that regulation will be. necessary only until the commission has
complaUd its work, they favor short-term or "interim" I slation.
Wribus', *Itnesses before the subcommittee supported the ffe usion in
a sunset clause that would compel Congress to reconsiaer
regulation of recombinant DNA research after a few-
The sube6mmittee also heard proposaJs to limit the scope of regula-
fion Philip Handler urged that only P3 d P4 facilities be required
to fb lixnsed d ected. Halvorson woaunld exempt Pl-level experi-
nvAhtslrom aJl regulation. Others have recommended that the law
dir _ot, the 'Secretary to identify "non-novel" experiments, producing
DNA recombinant that are known to occur in nature and are there-
these would be exempt from regulatio alto-
&re, Presumably 'safe, n
jether. Alternatively, the defimition -of recombinant DNA research
ktivities could exclude certainkinds of experiments.
A rehftd ime conceriik; the pending revisions of the physical and
biolo kal conttinment standards required by the Xi ily'1976 guidelines.
"wse_ ehtnges were recommended by the: NIH Recombinant Advisory,
Coiwnittei published in the Federal Register on September 27; 1977,
ant we.now behM considered by the Director. In the subcommittee's
sp tativtsz of environmental organizations a;rgued that
106 tt&4flusive evidence exists to justify relaxati6n of the present stand-
0&;: :On th othsr 'hand, savtral-s ientists,:;while appi
prdhWitions and Testrictimis on' experiments, are tanvinced that thes6
ith A. .. 111M
ts are-too striwnt,'tt least wl 'respeft to,' A" ofk. CON
;=.T'8M0=6r systems. Th6y pref, erred that the -proposed revigions
of the guidelines be the basis of regulation-un, h6w legiAlatilmi. A
A10 thor
M7 61'tnelsm ur&d that an -futum have4u
0.L M30dify the, st&ndiirds:iu light of new' scientifie(datae: whothor anch





iii~ii~ilii2 8 .
ev iiidec revea l at the rii~i-ar i ese orI i less' thn s'nwiilou
to be.. the case ii .... i iii ... L]i
Therei~iii hav also beeiaiou sugsin for=iiiiiiiii iiiiiiioraiiing i

ideie nlw h ials ppoc ssi ob r
uponi en ct en of....slti.,....guie.ies..ll.b..p.ica le..6..
sponsorsi ani odcoso eobnntD Arsac ihufr
ther adiita iacin-Ascnalentvwihniipesh,
nedo proedra pro ii prpiat t te riatisctrist
e x t e nd........ t he g u............................................... i deiiiii li n es!iiiiiiiiiii~iiiiiii~iiiii! i ................. a s ....................... .................................... r u e a nd.......................n
offnlrgltoswti ,eic ....... oftm. hr'Cnrs
cuddseswihteitrmetn ioftegilnsadrque
thati comprehensl ii! iveii .....ulat=i ons be issed
V=!i ew i~ ofi!ii the.................... .... su c m m t e
T h su c mitte beie s ........... kn w e g of....................
b i n t ......................... e x e i e t t o w i l l ...................................................... .. .....
in the. .....................c..ves igat on.P.oge.s.n.....m
its safety will ............... acm ie yrpddvlpeto h ehiv
a!nd s favait fhotvco sses ac eurngeaut!
Frmisprpciethsucmitepeesterainofnad
v;iiisr apaats.ncuig..etit.ndlypesn,.prtigo
" c o............................................................................................ ............ o r.......... .. ...........................................
"i fial jdmn ihn nabtaytiepro.Wentepop,
.... .eii us s.................... re be te k o w t il b
unnecessary to='iiii .................... thii r laniubiiiiiiisu sofh ma e





29
AA*6ughi wnibatibln of the recommended 0 1, but the subcom-
lae: that receint'faffinvi a etrefid miBion
and biological emteinntent, standards for butain ex-
OrlaWB There is also a clear need to correct existing procedural
wind to devise ways of Vying the standards to, privatelv
fo&nMiLreh nctivities incl 12*111 Hate meth6ds of moni-
Nnttnfofting compliance.- Because the sanctions and admin-
,,it #ddAm of thecurrent, gmdelines are predicated upon the NIH
ftVi6i-pr*c* legislation cannot meftfy "extend" the guidelines
'Foe thm r6asoAs, the subcommittee favors a provnion uirih
promulgation of standards and requirements necessary to secure
maintain compliance as soon as practicable after passage of legislation.
This appr9ach would permit both substantive and procedural amend-
, ents to t4p *d 1* The subcommittee stroi
gui e ines 3.gly supports the
4. on 0 f the administering agency to make further changes in the
Avds,, provide that the su pi rting evidence 113 published and
Ple Oportwiity for I? &Mc comment. In order to avoid pro-
d014Y in issuing the initial re tio however, it my be
the requ rementsVfthel&ninistrative Proce-
WHO SE[ObID REGUXATE
le biftat DNA debate has generated A vari44 bf pwpta&
fiDr I&Oj &td 106gl ftgalatofy agnmdes comwfiziotw and coinmit-
tew* t iWO 19 the ext,6 i to *IdA ie rch ftient-kft"siQd be en-
th 'With kedponsibihity for their ovvh totdad, indd*d4utlly or
t'hkough revle*, or be sqbj! rd to external ser4iny and 0,ontrol.
*Iated iss-des are dk6 ce, betvnen Pedbrid and SWe or
low t oapo*bffities and the appropriate role, of lay persorit -in, the
'nga*tion oi vecombinant DNA research. '
In M#islkbive Uwms, tliese issues raise the following qu6stions: First,
*hIch Pedgril agency should have au'thoirity to i8aue and enfo" rules
PV0141V r vnbiliiuit DNA rasearch? Se6aiid, -what app'amtas
should be esfalblished to provide etpett sagemment 6f the riskA asiwj-
I ited vith pu& researdi and to remjhmmd measures to protect public
hk- Ithina t& Onvirontient. against those risky! Third, whol slould
I* ike te "nffibilitibq of Mistitutions AAd M"vestilptors conduding re-
WAAAnW& DNA re9iAreh I Vourth, should ederal Government
pre&*Pt tM, itathority of States and localities iA tho inftrest of uni-
form 1 601WOTL I
"agemV
Saverol witnesses diimussed the merits sind dmwbwks of Ift
gvgaWoU. authanit National tutes of Awdtb. JOWN
Wnp the: Vi4vwsity of CaWorn:i& at S&nF=cisw
** Od th" XM -has the gm&t4*L &Xporbise 10C la"IM'Stm, W.-Al
1 11 Wg i Y W
t7. ,
I aforeU the momi tor mi ago Lut *ir view wpm in tu minor-
JU 1q 0 st41
j., g yt
M Director ip f sCat;bdtl d there 'I's "an Wuwant 9on-
flict of intareWl in the agency% b6th Oohw tbv the ftb4fth iM AL4&
or










a.iffod =afet t o itiss nd he Yu aogotes



o.hred withDrcomricko'eomnaio htiseto
and enforeen athrityb rnfre oaohrarc nH~
perhapsi the Cente for Dises Cotriiiisexesieexeiec
in controllingiii infectiiiou agents adspisin laoaoyPW











aicul Gtal sa meit in tria mcreonbof aninnden otla
gent m nipution reevn th ara doetn eodcosdrtoso





theahrch ofactes1and proedues and foermopiodrionas
ei sediii~~ii on co m m ittee m em bers' involvem ent in reco m b inan t D NA ...


andi~ in,11,-,areste in the~ii ir appiil iaionbtno xer nte sesm ,o
theiii~iii iiiiiiiiiiir effects. He charged that scientistsi with relevant experienceiii in
publ iic helth, pollution micrbilecloy ad mpaioihalh
for example, had "essenialyenixlue foiteprcedns.A
Futeroe th dioycmiti'ielacin nulshdd


iI "in idigh, iis larta tegudlneioudhvebe

d~i-e wi much getrbic inu. oayteciiim
wh i i wol become. inrasnl delteiu toscece..'oi




hos -ve to sysems wouldi be c m o e ofsii st ......................



se-o-!;i !inits ofi~~ iiiiiy andposili cludin sieistigg~ i

r] orb;)P-n N wrwol ppoeordsppoe bttno-mn
i(- ii Ti oy e re ultins suggesiiii how'Ni' the re ul ti n arei ,, to fW ........... @ii
=: iiiiiiiiii ==iii :iiiii i~ ======andiiiiiiiii =ii ii m ake.. ot e e o m n a ionsiiiiiii based on a cmnt= i -i






31
to an institutional biosafety.committes. These committees commonl?,
include researchers engaged in recombinant'DNA work, other know _
edgeable scientists, members of professional school or liberal arts fac-
illties, andy in some instances, public members, although the guide-
lines do not specify their composition or appointment procedures.
Ila all cam, service is voluntary and in addition to members' other
respongbilities.
Nearly all of the subcommittee's witnesses, including representatives
of the private sector, supported a provision for onsite review, commit-
tees, though for somewhat different reasons. Many scientists regard the
biossfety committee as an essential instrument of self-regulation,
others as a mechanism for employee participation and public's crutiny.
Some observers nuestion whether a part-time committee, most of whose
inembem have cf( rties to the institution and researchers engaged in
recombitant DNA work, can be expected to monitor the research care-
an nation usly. Thus, there is moderate
disa t, not only about the committees' composition but also
'ut their: functions and accountability. Harlyn Halvorson, s eaki
f0r' the Society of Aficrobiology, recommended t at eac
biomfety committee include public representatives but have a major-
ity of members with "technical expertise in the activities conducted at
the institution in question." King considered it 11* * imperative that
laboratory workers be fully involved in decisionniaking proc-
esw Their representatives must sit on biohazard commit-
tees Marshiall Shapo, observed, from his own experience on
the University of Virginia biohazard committee, * It (is) im.-
port nt that we give opportunities for intrainstitutional collegial dis-
cussion, and we also do for some kind of independent
review outside of the P that the people who are doing the
review oo not people ho, are'in any substantial way beholden to
those who are doing the research."
Role of State and loca7 governme.W8
In their testimony before the subcommittee, representatives of both
the American Society for Microbiology and the ]Pharmaceutical Man-
ufacturers Association predicated their support of legislation on its
preemption of State and local laws imposing greater restrictions on
recoMbinant DNA activities than those provided by the Federal
standWrds. Harlyn Halvorson stated, "It is our fear that if this is not
done, we will see a patchwork of conflicting laws regulating micro-
OFganisms which recognize no political or geographical boun-
airry Excessive and variable restrictions would increase the
cost of recombinant DNA research and could lead, in many cases, to
4bandonment of such research." Joseph Stetler of the PMA agreed,
"A.-Proliferation of State or local laws and regulations would prob-
abl$ not increase -safetv, but it could seriously impede the development
of the potential benefits of this new technology-"
Pubfic 'interest group representatives were equallv insistent that
States and localities be permitted to im ose stricter st ndards. Marcia
Cloveland of the Natural Resources Defense Council argued that leav-
ing the-way open for State and local regulation is essential. as an ave-
InIte for public participation and political outlet for public opposition.
"* When citizens are aroused about the hazards of recombinant








a
DeiulNA, y imp coiggrssyna Furtneo-

mthe r ar esay eea eultr rgas hc eyo



aged eral t4 diest.Iserp atclr esAwyMM





...t iiiii i i ii iiiiiithei T i iii
Tho trovrs rersetby these oppsn op f iwl


hN ib itie n onent freom potec inubic eltyteenionet
Aesucodigtoe oste iteasses h ehe tice taead oa
or local ovems ve eclgwehrSae oaiishv

dmotated a srnleir orglt robnn IV ciiis
wer sicee ic tl
lines there istr ropeln a rci rf









oermttin Sat an loalgoerents4 torglt s hyseft
T e clee hasoun ihiiiil p










tlurend in een ral acaemi comnteen fwSaei a
gix0eresentctto
giealnresule of the pssge oflesainmr

conainmen laboaoies. JsephGayodponC.ctdusc
cessful~i eifsi abigMs. oso osrcionofaP3lao
raoywi Brc ei fteUiest fMsahstsrfre
to a ropoal, inc reetdb h e ese eateto elh
toimps K rqireet o l eximnH comntd
"Idn' hnkta i jsifie***.Itikhawolbeni-
hbtoonsiniifreoofiur.
Aco di gtooh r iness ................ prospect of such............tat
or loca go er me t hav becom incai ngliiiiiiiiiiiiiiii ly remotie.iiailergof



ulrl sic i w"fet ht heapaeniaiur f heNHuie
lines, tocove i ~in r represented ................... A n the..............
of the P Aa greediii thatiiiiiiiiiiiiiii ther w o l "notiiiil bei!~ii!iiii aiiiiiiiiiii!!!i lotiiiiiiiiii~il ofiiiii enthuiiiiii
i=iin locl com muniii i tiiiiliii i e to pr ce d oncei Congress acts to regulate alliiiiili~~~iiiiii iilii!i~~iiii iiii~ iiiliiiii~iii

tend toi conf=iii rm thes imiessios Tnreuiin al ecmbnat -


Cai iii li ........ C ity C niii~i noted!!! that "theii g-ii dl i neisiii areii onlyli applicable...
N T TT -fi~ research,~i w hiiiiiliii iii!i iiiiiiiiiiiiiii iiiii=ii il e iiiiiiii n o-ii- u n e i| !iiiaie andiiiii=iiiii ipiiuib-i=! i~i! iii=iiiii~ ii== iiii= iii iiiiiiiiiiii = i~i
ie research project ciiiilliii n il iiiii! t =!!ii= be. un e ultd. Qr n n o
i070 NS Octbe iiiiiiii 197i 7.)iiiiiii Shortiiiii i ii l y afteriiiiii the subcoriiii teii hear-
iiiiiiiiii the iii Ne ese P i c H at onil u a imosyaotda





83
WdiAg resolution that the conduct of artificial recombinant DNA
OftUmb m the State be carried out under the NIH *dalnies. Ae-
OoWitg to the attrney aI of New Jersey, the council "chose not
to: adopt the positions or Ttherpolublic advocate and its own "AA-Mg of-
Am regarding any ifications of the NIH guidelineLIP
. An exception is a resolution of the New York Council (No. 1018,
Aurmt 25, M7), calling on the Cbngress "to preserve local autonomy,"
in the regulation. of recombinant DNA reseanh, akhough the Gover-
Ow of New York, in vetoing a bidl passed by the State legislature,
**W that such regulation "should be national in application and not
unposed in random fashion from State to State." (Statement of Gov.
Hug"AL Carey, August 12,1977.)
On: the other hand, there are areas of public health where the States
hvve traditionally had regulatory responsibilities and developed some
comp6tence. Marc LapPe referred to the California Health Depart-
wAenVs supervision of clinical laboratories. In a letter submitted to the
subcommittee, the director of the laboratory division of the Connect-
icut State Department of Health reported that his agency had regis-
tered and inspected facilities 'n ed recombinant DNA research
ih accord with the State's pubTleg he'alth statutes and regulations.
,Pavi&Newburger, professor of law at Washington University in St.
T"is, generalized:
Under our Federal system of government, the States have a right to protect
the health and safety of their citizens, just as the Federal Government exercises
some rights i1a that area on a nationwide basis. Unless them is some compelling
national reason for us to distinguish this kind of research from all other re-
searcla, I cannot see any reason to preempt the area.
V" of Me Mbwmmittee
The subcommittee believes that legislation or administrative action
to rMilate recombinant DNA research should correct the deficiencies
of the present system but retain its successful features as well as
maintain continuity. In view of the fact that existing statutory author-
Ries,: are, on the whole, adequate to regulate commercial applications
of the technology, no new Tederal agency is needed. (See below.)
InM*4 legislation should assign authority to the Secretary of Healtli,
Education, andi Welfare, who will draw upon the expertise of NIH
in formuistin standards but sh6uld delogate monitoring and enforce-
MMt res msififllities' to the Center for Disease Control or an6ther suit-
able agency in the Department. The subcommittee agrees that NIH
may sppear to be compromised by its conunitment to supporting re-
combifiant DNA research; nor is it well equipped by previous regu][a-
'tory experience to perform the latter functi6ns. The mbeommittee is
wncerned that HEW give adequate attention to recombinant DNA
research directed toward agricultural, ene d 6ther nonhealth
a;pplications, but believes that no other FederTn;rncy has comparable
expertise in the broad range of work with recombinant DNA.
The present membership of the Recombinant DNA MoleMle Pro-
gram Advisory Committee should fonn the core of an expanded ad-
-visory committee to the Secretary, includir* members with expertise
in tegalatory procedures, safety andhealth regulation, and laboratory
*Ork. TAv opinion should also be repre.9ent6d. In view of the raPid
of recombinant DNA research, however, the legislar





'i' iii ii~~ ~~iiiii! ~~~~~~iiiiii~~~~~~iiiiiii~~~~~~Q Aii ~iiiiii
................ s eif th "c m ites co p ston i d bl P
suconiit aeflycniee o uts'-rpslt sals


a iiidliiial poii li cy asp ct of eve theiiiiiiii phyica andbioogcal....
metsadrso otvco prvlcno eraiyitn
:isie.Mroecmuiainaogsinitan osotss
whoiiii adiethiertaysoldi~i be enorgdrte hnihb
Th enare adisoycmitesoudcniu oexrie hiu
..i asigndt h ecmiatAvsr Cmite frc
omnin chne in h euain'n vlaighs-wo
,ssessbitdfrcriiain
T hei s u b c o m m it t ee ... ................. ............................................. ........ iiei



haesmiceini teapimts
The s b oi ......................mbe s o i stiuti na
........cm ite wil hav sufi inttmean.otvtinto.oior..
,mnsrglryadt netgtetoogl|leain fVoa
tins fte euain.Tecmitespiayrsosblte

shul bet prv eerhfclte nircdrsfridvda





335

Federal prwmptir u xvine' K reasons in
st
'annarle. Iresentation. of cor
support of stricte State or politically sumvision would
4e Pernaitted to take other actions to assure its citizens that the Federal
#andar*were being observed. These actions include registering and
juspectingig facilities, requiring public representation on the institu-
A 1 61 bi' fety committee, investigating alleged violations of applica-
ble, regulations, and seeking an injunction to stop a violation. A State
woula also have standing in Federal court to obtain injunctive relief,
Dendinff. an investigation and appropriate action by the Secretary, irk
b; =_h&ly emergency that an activity being conducted in compliance
with the regulations were found by the court to pose an imminent
dikest to, the health of laboratory workers or the general public. Fin-
ally, R'State, community, private organization or citizen should hav6
an opportunity to comment to the Secretary on an application to con-
d6d remnibinant DNA research.
..A.: la ity of NIH research grants are made to institutions
.. ..rge majori
rather than individuals, but it is the principal inves iga o
t' t r who bears
res ionsibili y for compliance with the N111 recombinant
rl researe guidelines and can be held accountable for disregarding
Among other duties, he or she must submit with the grant
application to NIH a Memorandw-n of Understanding and Agree-
midat,(MUA), certified by the institutional biosafety conunittee, and
dewibmig the proposed experiment and the procedures and facilities
that will be used to achieve the required levels of physical and bio-
logkal containment. The NIH Office of Recombinant DNA Activities
npLst review and approve or disapprove the proposed MUA before
the work can begin. In the event of a violation of these procedures or
standards, NIHIs only recourse, is to deny the use of grant funds
fpr rwombinant. DM. experiments or halt further expenditures of
grant funds if the experiment is m' progress. The latter inay be an
qmbarr&ssment to the institution but is a relatively severe sanction
fw the principal investigator and his colleagues on the project. NIH
has taken this action in only one instance, upor!, discovering that no
M-UA had been approved, as required, for a. project begun before the
gwidelkeswere issued.
. Witnesses before the subcommittee acknowledged the need to devise
no-Fprocedures applicable to t)rivately supported research activitie&,
What impressed the subcommittee, however, was the degree of con-
semus on elements. of a regulatory system. appropriate to both the
Womic and industrialsectors. Stetler of the PMA, Halvorson of the.
A$M, Joseph Keyes of the AmericAn Asso6ation of Medical C"Ollegns,
anA OSTP Director Frank Press all advised against licensure of.m--
47idual researchers as "onerous and burdensome" but recommended
a sysWm. of F ederal licensing of facilities to conduct recombinant
]D jA work. They said that revocation or snspension of such a license
would be an, effective deteimnt to misconduct. Steder also proposed
the registration of individual research projects with the Federal
agBney, although primarily. for inforinafional purpose& Grady of
-Vp t of. au, MUA4
john.suggested.that researciters, file the equivalew









The ni that a ths of inv t on must be Ident and a
advance.f.... iof the Uinivierls mefhW insns iwhdi ch the ru of one
step in th rcesg i th netdcso on. u br om review.........




erkemiens orocondt ma roinge expernta poe untr
imilarly, wignsses Aeeal poe rvsosfrsiueo e
searatrias hior fis of trimnal thenatin fofrh violtos

hadsi n t aeade mic thae n n inuthiee ac scintit-
colateon waritula ffens.Weakdwatato should beni
thIvetofavition of uithe cotinetsadrOlvrSihs

poff UniestafWsonsnsi ht twudbaporaet
eokhiene for cnuii oii p i






untesdut ofnsm ldess~ te biooffenseigtmrtcoigfth
Waithefnc orthebavior Nof iniiulreerhDavdNw
durefr sui on itoringli e alsi reare! i a ii i








Whslain ihte sol liateyhv h oer tion controtlou the codp
ofndviut i th labratrie ... .. flye....











naboto reurgeubison of inomto nrcmi
...... ofi failitie at ailfor cni nmn levels, wh1Youn

















ofte anvriyo ohse rfre htisetosb iie
to 6he higher containment..........i. Jonathan King noe t p

ri





ant... DN.........ha I sol ivs i eelpn poe





3 7 ..... .
iiii36 In d oub t; bu t ~~iiiiiiHHH ~iiiH ~iii~i~~iHiiHHiii e icHiii~i~iHHHiiiiii~iiiiiii~ii~i i nt r r t t o oriiiiiiiiiiiiiiiiiii
ta~~~~~~~ly~~~ upols....ptet........pliy.oud.erit..ane


,i~ttinstoacurepxens ndawr lcese fr ecm it

,DNA. iscovries. s fourth prvutiiectoriiiiiiiiiiiiiiiiiiresi
*at:Atmad C prdiced tat he isec~tyof pten rigts oul


Aker mwerial irms rom vesi '7 n th iiiiiiiiiofiiiim
4inmtDNA aplictions "(We wi~ be wthouiaiiiiiiiiiifo
vdul.6 lotatin of tecnolo whichwas nvenediinthisiiii
M_ -itvi cot, ail beieploit elsehere.
the baefee ostatturyprotctio of he cnfiiitiaity f fe
searc plas, te Fredom f Inmmatin Ac (5iiiiii552)woul
4UMMther, iscosue bythereq~atry genc. Sbsetio (b (4
of te VIA roviesnn xceticmfro mmdatry dsclsur fo
$ Mfto tht 90 ** *trae wrdsAli comerialor itine.1 iiiiiiiiii

inad obtiftdf~mx & erso an priilegd orcoiiiiiiiiii bu
madaait Ad idqstial citnids egar them-caleaiiiiiiiiii ex
4mnpton a inaequae on seveal cunts In iiiigin i8iiC
Imi V.; eow~tmett of Aralthl eucatiah hdiiiiiafti(50
F1,Rd,28 (DC. ir 194)) tp curt6fL~el -ffrme a owiiiiii
vwwtdedionordthi remL*of eserchgriit p RHlctias f iiiiiidi
ilig ilpaimentl-'p6"Is n th qrtpds tat iiiiiwreinotrad
secres in 1111noomn rcialIiiiiii8iiiii.1
The art drthr sad tht "i defes cmmanensitoipetenitha




hkh~tho~reiiiiiioneiii whether














dir to cte ai lag eea*ueurc o iesn fiiln

thaia prodtv reeach. On teohrhnacmpihet rsie
descriee a ies an poil ihteus frcminn Na
wesath is oh p r oms resac tehiue oe cetit4r
alrad onvi ~ed thti oeoo infcn eat revrn
make uhard some ma beicieto usiuethi w ug
mn vol afton fo thtoreeuatr h nietsah nvr
sqiit fairi atan Frncsc inesoetene o rae
achountability.d
There upp r priiri the ai











prescorib tios, prive lbrtresirter uooos iiin


rtarydctterserh Apoa should hav authoritya too aishow
pdin v atitechif theinstatieofcro h nttto apone
aiii~ii iiilie i osft review committee thoroughlyfamiliar withithe






fo the etraiin of investi a lb ry personneliin proper












peerhs onuced o ae regonutd basis.heistttinmutage

the uspeion of atonmrehan3yer.Ith institutional
............... ino m to oaheec m la c nesp iately supported asii-=


















prcdrsta ilbe s ed, an te aata h ertr a
pecibdual Te pe should no be subject to th ...... review
gi en F e er liiiii=== iiiiii research grantiii appi~ l i ti ons;iiiih= :::::::::::::: ............ indeed~iiii= itii woul be...ro
............................. for iaiprojecti to co m m enc un==iii l ess the D epartm.........en.. .......t raised objec-ii~iiiiiiiiiiiiiiii........
ions iiniiiiiiiii ... ......... i od i of.. time suc asi 14 days.... To th xtn

feibl e, qualiied i nsittina or.. lo a ..................ld b ap
retary should haveauthrity inspect reseach facilitie and to orde




The supi onii of~! an insti~iuioa com iteeis........ncio t
be reserved fo ae ae o eiosdreitono hepr o h
institioa offiial otir gns vn h ihrwafaFd
eral granti mayiiinotiibei aniappropriatei responseili to misconductii byi ian
=i!iniida or a ml ru f-eerhr.Cvlpnlismyb




39

1M.PrIate in cases of knowing violations, but the subcommittee also
Vecomamends that the Secretar-y have authority to suspend research
bei g conducted in violation f the regulations and persons from
parlacipating in recombinant DNA research for a specified period of
ii me. With regard to both institutional and individual suspensions, the
$eQretary should be able to issue an administrative order rather than
bb obli-ved to seek a court injunction. The judicial route would incur
delay and might require a showing of harm or potential harm. Never-
*eless, due process must be assured; the more severe the penalty, the
bre rigorous should be the procedural safeguards.
The subcommittee believes that realization of the benefits of rerom-
bihant DNA technology requires some protection of the confiden-
tiality of research ideas and procedures, but it recognizes the piiblic's
r of access to information necessary to judge compliance with the
Meral standards and their effectiveness in protecting public health
thd- the environment. Unfortunately, the subcommittee has found
idd ifleal balance between these competing values. Two major study
oyhmiissions have recognized, however, that the disclosure of aca-
dd&ic, respamh protocols, submitted in application for Federal
6MCIS, i a generic roblem, not limited to research with recom-
bimmi DNA. Ind:J, enactment of legislation to regulate such
resmreh would not si i-ficantly increase the likelihood of such
diidosures. Consequent, rVy., the legislation should not establish for
rewmbinant DNA researchers a right of confidentiality which
is not acA*rded to other scientists. Rather, for the time being, HEW
should continue its resent policy of refusing to disclose a grant
,.plication p ding and after consultation with the granted,
d maintaining, the. confidentiality of potentially patentable informa-
ti.on contained in a funded research protocol. In the long ran, this
a y a&ninistrative burden d *bly further
lie-Y May entail heav an possi.
himition. The appropriate committees of Congress should therefore
the Meneml problem of protectin intellectual property ht
as the Presiaent's eidniedical RawLmh fan'el and the Nation'al7uom-
r, is m for the ProtecEon of Human Subjects of. Biomedical and
belavioral Research have recommendedL
Regulation of the use of recombinant DNIA techniques would expose
the private sector to disclosure of properietary information at thebe-
guming of research and development, whereas present Government
regultation, of products and processes is limited for the most part to
the manufacturing and testing stages. The subcommittee believes that
some Measure 41f protection against this risk of disclosure should be
provided, wa&Hy in view of the fact that recombinant DNA tecli-
niques ma yesC only a part of a larger reLsearch project. Nevertheless,
thi'concern of the Pharmaceutical manufacturers and. others is also
a general one; they argue that regulatory agency and court inter-
P retadons of subsection (b) (4) of the FOIA and 18 TJ.SwC. 1905 fail
to Protect much trade secret: informatioi4 particularly against dis.-
cloSu re, to competitors.
R.The subcommittee doubts that t e. solution lies in attempt-
*.g t o define in recombinant DNA legislation categoriea of informa-
tiph, 'Some of which would remain confidential and ot4ers be subject
to disclosure, Instead, the legislation should establish,& notification

23-890-78----4






aAnd




andcostei proedure siia otatfloe y ndcd
reints.rvco it h n
hes ds i uis e pssi c a t of re-







coinatDArsacvaenmruicldnsh rdion of
tiermcunrticlpsiieezmshln rwhsiuaos n


meii e, agiltr e thand th osmrPWiesm ppiain

tneoresath mat edcdsaaohr ol eaalbewti
aoeoed u se














oethcide prdction WofC lag cuet frcmian N ra
uses of rcominan DNAi~ tohi sfrcmerilproe r
fuliiiiiiii!iiii~i~ily un ders!i~ t oo an d ap p rop riateii safeg uards areili establish ed toii p re-ii ~ii iiiiii i iiii!iii~l~iiiiiiiiiiiiiiiiiiiii~iiiiiiiiiiiiiiiiiiii iii! iiiiii 1iiiii~iiiiiiiiiiiiii il iii
vent any undue risk to humun health or the environment. The follow- ii~iii i i !iiiiii
in ec i niimi e aiiiii n u m~ ii~iiii ofii~iiiiiiiiii~ii~ii~~iiii~i~i~iii~i p o iy iii iss e ............ toiiii th aiiippiii-iiiiiiiiiii
,cat !i .......... reomint DNA tehoog.Dcue ..rltngth
-applicabilityiiiiii~ii~iiiiiiiiiiiiiiiiiiiiii ofi cur en sttu es to th r gu a ion. of ......plca
tin ax includedi the appendix.i ii



(Se appedix. Si7 ~iiiic ag numbe oiiif sttue areinoleditha
beeni7i~ argedihaith moirect wa odelwthtepobe socn
sidt all of ii the" reuatratoity within. a' singleagenc.....
siigl authrity 7In fat smleisain(oexmlS127wud
ecivl preeptl Feea statutes..x......h.......aionlSft
andi H ealth A ct{~iiiii~ 7iii! (29i U .S .C, iiiii~i 63iiiiii~~~ifii iiiiiii~ iiiiii7 1 et.iiiiiiii seq (O S H A ))iiiiiiii ,! and lodge responsi-i 1ii ii~i i~iiiii iiiiiii i i iiiiiiii iiiiii i ii iiii~
ii tyiiiiiiiiiiiiii{ for theiii re ul t iiii .. i71io all re om in n D NA aciiti esii iiiii
SertayofHatii EduictioadWlrer anipnet. 4O
misin Th s whether or~i7ii i ii iiiiiiiiii~l noitil a. recombi~iiiii nantJ D N applications isi pesti-i i7ii77i i i7ii~i iii ~iii77
cidal (now sbject to th juriifimiiif~iiii~liiiiimii f th ni ronmental Protectioni~i
-Xg ency ), orf nd u st ia p u p o e .............................................


Trnprtto' jursdctin) solel reglaoryreposibliy wulb
veste iniii a~ sigle agency. 7
Whleacolidaino uhrt perst ei h neeto
adiisraive fficieny itwol..plcteepetiean.rsoni
iitie nweisingwthnohe gnce f oenmn.Fo x

amle, iiiiTiif an aenyocmisionwr ie uidcinoe
proose us f eomian NAt cnro nscs nagiulua
crps this grant of authrity would duplicae the function an
expert i~i ofiii EPAi underii the Federa Insecicide Fungicide, and iiii i i~ii ii ii ii iiiii i ....iii iiiiiiiiiiiiiiiiiiiii
Rodenticidef~ At7 USC 33e e.(IFA.Smlrdpia




41|


Om woud occu withrespec to tansporationwastedisposl, an
G o r b e s t a n b s o i.............................................................t D N A iiiiiii
Hed ad o icheim and regulatoriiii
Mit h've ledybe establihed.""" "HH""' The types of regulatory
fens.ree.ed b .........DA..y dife,.owve
J~rMUthoe f .covenioal atrias eguatd ude e istm iii~iil
lava ad requre speialize traiing oradditinal pesonne
Iiq~iiar -ith te scintifi aspets ofrecominantDNA. onethless
'Withthe eceptin of egulaion o reserch ativites fo whic HEW
learentl ha priaryrespnsiilit, cosoldatin o allautioiyi
th e ar m n o EI o nin e e de tc misi .............. rq ieiiiiiiiiiiii
creating a ne.amnita..esrutr.an.ssmlig.h.eprts
-t &I it telagenube o otntalapliaios f ecmit
-DNA teii~mlogy.

APLIAB17Y I EIS1M &ATT
Gief te peultie naur f heevntaluss f ecmit
'DA eeac, tisdffclttietiyprcseyth iffrn
ldd f ubichelt ad nvrnmntl roles ha my x!e

Nasttee, om osrvtin a aprpiae.Ter ae umero










ori~ celrtete production of mtaeo yrgnb ir-ra

presumablyincluighir use in
wOu myeaboibitoriimith emr cias otaecom

boecuAlberteof- th oagebytatacufNAmleuls
Sect or 3(he denfine hile musay ujc tro teca"n
meganic or iogniro subtane o atcuaoeuariett.
Theeinitionaloicue"ayeeeto nobndrda.1Its
tuclathDAmlcules or sget fDAmlclsa

fulsubett tpenex proiions ofe TOCicuig h ru



oatrgntc poiin oscn 5





phreual inldn hias nogaim.Freape P
mlecuins nogns htwudpesn nesnbersst
cules or sgment ofl DNA. Nonetheil es i th absence ..............
ati ty ad si ngiiiiiiiiii~iiiiii the recombiiii nantii DN qsi on, EPA has com-iiiiii


m ittedii itself to u iiin th uoi t une i o h uls
(Se Appedix. C lariin th...... orec ognsm tiie
in recombii Aaciiie wol lo nuethttoeesn
pucaigDArcmiat rm rdcrfrteproeo


Section 361 of the Public Health Service Act (42 U.S.C. 264) pro-i
vide the Sertr fHatEuainadWlaewtuhrt
to prevent commuical iae In reeat at ecin31uhr
izes ~i the i~ii Secretary to "iii mkead nfre uc eglaiasi
his judginent are ncsaytprvtthe nrdctotanmsin
or iii spreaa i ofcm u iable dii sae frmfrincutisit h
states or possess~i r ii~~ frm nesat o osesin nt nyote
stat or p sses i *l *iiii *11i ii
Beas of the broad diciongvnteSceaythsbe
argued thati scion36 poids ufiietauhoiy o otrlh
meta Defns Fundi an h NtrlReoresDfne oni
petiiioe the Sertr ofii HE onNvmer1,17, s i
to iimp contrl ovralrcinatD Aatvte ne eto






43

4&11 seq. (NEPA)), requires in part that all agencies shall
bmr6 * that presently unquantified environmental amenities
and vulues be gi en appropriate consideration iii decisionmaking
Mon wi economic and technical considerations. (see. 102(2)
(B)_f It has been argued that NEPA requires agencies to protect the
en*ironment in actions taken, whether or not the authorizing statute
SP04"affly provides for environmental protection. Thus, once an
sigen-ey has established jurisdiction over a substance for whatever pur-
posel then it is automatically obligated in its actions to protect the
t avironment.
The extent to which NEPA imposes an additional substantive duty
upon each Federal official to protect the environment has not been
6itomsively litigated. Nonetheless, in three important cases (Calvert
Clift v. AEC (2 ERC 1779), Zabel v. Tabb (1 ER 1449), and EDF v.
Aftiffhew (8 ERC 1879)) the courts have upheld the authority and
Iwponsibility of agencies to protect the environment, notwithstanding
an'Authorizing statute which does not explicitly provide for environ-
mental protection.
While the authority of section 361 is broad and arguably could reach
many, if not all, of the commercial applications of recombinant
DNA research, it is highly unlikely that the Secretary of HEW will
uge the authority in this manner. In the absence of definitive judicial
.r#lings, using section 361 of the Public Health Service Act to safe-
g ftrd the environment could result in litigation.
rREVIENnON OF HAZARDS
With the passage of TOSCA in October 1976, Congress established
the principle that chemical hazards should be controfted before their
hazards become manifest. The act's mechanisms for premarket review,
.Which. were m part patterned after similar provisions in pesticide and
drug law, provided the first comprehensive means of enablmi gu-
Istors to review hazards and take action before a substance rc:Me's the
channels of commerce. Experience, in recent years with such chemical
disasters'as PCB, kepone, PBB, vinyl chloride, and others demon-
strated that the Nation could no longrr afford to act against chemicals
after the damage was done. In his envirom-nental message of April 1977
President Carter reiterated this policy and stated emphatically that the
administration embraces preventive control. The reasoning that re-
sultod in the preventive control measures in TOSCA and other statutes
applies as well to commercial products developed with recombinant
DNA tAcImiques.
Apart froin FIFRA and the FDCA, the only statute explicitly pro-
yiding for premanufacturing review is TOSCA. The premanufactur-
ing review coverage of TOSCA is broad, excluding only pesticides,
to acco and tobacco products, nuclear material, firearms, materials sub-
ject to FDCAI and mixtures of chemical substance& While other statu-
tory authorities, like section 361 of the PHS Act, may also be inter-
prpted to provide this type of authorit-.y, the explicit terms of TOSCA
provide fGr premanufacture review a new chemical substances and
significant new uses of existing ones. However, the limitations of
TDSCA described above relative to the coverage of recombinant M U





















































Pesticides, a


44






.............................................i5 i



etiatthat onge intmed tht Mawitu ML beapprved fr us
iiii3-iiiii
Uh~l i~breidetiie ON UtM,"1W mde o th eten t w ihi~iiiii
Asks of remmnmt DN technology;
is ecae he reanfatuiii~ii
Wn'&Wproviionsof thn theeisttute
nwessay adjnct t any mchaniiforiiiiinuaiiiiiiiie
v** s th autorit totakereguator acton heretheriisiaus
f~rconer bu n ireftabe vidnc ofinury Wileths yiniiiiiiiiiiii
itmb~ce i mst attescotrllig azados ateias, iiiiiiiii
pt~im~rl portnt. hen ontrllingrisk assciatd wih re
combinnt WAappliation sine we kowifailow bout heir ffect
ca kealh and a iniiinnwnt
: Afer meobinnt DA mlecue o orgnis hasbeeiappove
$prus ad anuacur hs bgu, enmll agratr dgre f ikiiiiiiiii
=wt beeviden in orer to ake ation, n partbecaus the eonomi
oftedsof multion ae greaer. Wileiintheoryiniabsnce ofassur
i~meeof saety o a psticie or rug souldresul in wthdraal o
Aba~avl, ctin i rrel taen nles psiiveindcatrs f ikiii
am dv~lpedfro tet daa o oter vidnce Nontheess itis lea
dig v~ceof atualpiju, asppoed t ris, nedi-nt bedem
o~rW. ecnt ass i enirwneta la supot tisconluin.iiiii
Th6. *Jer xcepion apear to b in sandads esablihed fr th
Arofworkr holth nderOSHA Theauthrityof iii Scre
= 89f~borunde tha setis lmite to ecogizedhazads t th



i,.i
*04d* en' onmet. n Aereean inig ad Rfinig Cmpay v


TU Qe~tatioal afet an4Veath evie Comieson 501i.i2
W 09U ) te cort: uledthatthe egultoryauthrityundeitha

a~ve~g oly harbor cnturlinste kovm o'b di.......Whthe

08J~l authrity xtens to uantiimbleand eciiiive dnger
01ths qustioabl. (Se Apendi.)

TOSC, te Amimstttorof PA s'rqlhredto xeriel
hisa~hoit t te xtnttht iss ayno b pevntd r edce






46

Of the three principal statutes which might be used to control the
commercial products of recombinant DNA technology (FIFRA,
TOSCA, and FDCA), only the FDCA may contain sufficient author-
ity to insure that products subject to that act are manufactured in a
safe manner. Section 7101 (a) gives the Secretary of HEW authority
to issue general rules for the efficient enforcement. of the acL This
broad grant of authority may be sufficient to reach the manufacture
c; f recombinant D.NL' A
FIF-RA, while providing ample authority to proted againA hazards
associated Vnith the products of manufacture, contains no authority
whieli would enable the Administrator of EPA to impose requnv-
i.ients ith respect to the manner of manufacture. Likewise, TOSC-
while providing broad authority to deal nitlh recombinant DNA mole-
cules and ot-lier ehelru'cal substances, contains only lirrated authority
to specify the manner of manufacture. Section 6jb) of TOSCA en-
: Ules th Administrator to or-der that quality control procedures be
im-o-ked in the event a chemical substance or mixture is manufactured
or processed 'in a manner which unintent-10natly causes it to present
asonable ri ks to health or the environment. In addition, in im-
posing quality control procedures, the dministrator is required to
undertake a potentially time-consuming and laborious adjudicatory
procedure in order to impose requirements. While other statutes,
such as section 361 of the Public Health Service Act and perhaps the
plant and animal quarantmie laws, may be construed to provide this
kLiud of authority, an explicit statutory declaration of the authority
would be desirable.
Many of the problems associated with manufacture are similar to
those associated with conducting research with recombinant RNA
molecules. The scale is larger and, arguably, the opportunity for
environmental damage is greater in manufacturing situations than
iii research because of differences in personnel training, -volume of
materials used, and methods of production. Nonetheless, the types of
controls necessary to protect workers in the environment and com-
inercial manufacture are similar to those that mav be h-uposed in the
laboratory. W
Hazards to health and the environment that mav occur after com-
mercia-1 manufacture present different problems that must be ad-
dressed separately. While tests to determine health and environmental
effects may be similar, the control mechanisms developed to prevent
hazards in transportation, use, and disposal of the material will be
A-erv different 'n 'character than those applied inside the. laboratory
or manufacturing plant. The latter controls will be characterized
largely by biological and physical containment requirements similar
to those in the 'i\71H guidelines and -'future reggalations governing
experimentation.
TES=C. RMU1PJ0B"-\-rS
It Is 1MPEcit m" any premanufacturinu review sv---tem that decisions
to a;.Iprcve the man facture of reeorri6i-riant D-NA or derived prod-
uefs will be made intelligently with as. full knowledge as possible of
tlie r'sks. This means that test data relating to health wndelivtiron-
rnfntal eiTects must he available 'n the premanufacturing review







47iiii

#i~. s tht tesedecsios m mde roprly Itis lso 1.iiii
stemforpremnufcturi evie tht th reponiiiyi
IM11Uy pig etswih esec o eathan evrometa efet
WWU ~~~~ i......... !iiiiiiiihowllbnei eoomcll ro h
on.i
uhriyshud xstt rdrtetngate r !au

ci reiew~i orde to isurethatieaithandievironenta
wa is, cm-rnt Thre hav beenimporant imrovemnts recent
W 4&esig of wt mchansms or halthand nvirnmenal efect
O.:chmical ~~~~ substncesand..hermat.ials.Thedeveop.et.o....
w~vnin~systes, ncldin. te s-caledAme tet, or utaeneiii
and........................ctivity..s.......e..ndication..f....gress
inhaadststngtchoog.Th aalaiit:.o tsin utoi

Aoidd,~ ~~ ~ ~~~~~~~~~~ i hepisr httelts ntetn ehooyi sdfly
INA smy o Govrnmen wit reglator reasons ii p

cllbleto imobinnt NA echoloy ad rlatd poduts ls

B rserc athriy r ccssto t.Inaditon TSC cntin
'Authority for theiEPAiAdministratoritolrequireitestingibyiiiiiili
.......... and processor of ch m c ls b tn ew ih c ud includeiiiiiiiiiii~iiiiiiiiii









certain sauoyatoiis uha eto.3. ftePalcHat
Service Act, do not exlicitly provd orpriga' eodmp
ing, these requirements are presumably within the
Seretuar. Tothe extent thatothersta






a
or duplicative." As Jonathan King p
hearings, however, there are pr
vertent contaminations for adverse health oreclgalfets
Vie ws of the subcommittee
In. examining the anticipated uses of recombnn DAtchooy
the subcommittee recognizes the limits of pent knowlde ete
the course of r c and deve
ment can be predicted with acurayb
gestd, that commercial uses of
will -pose no threat; to pulic lt orteevrnen.O te
hand, the r f large-scale prod
DNA or may be greater thta
tion in research la~boratories.
Congress and the executive brat
hazards before theymaeilzWtthtimidte bcnite
has studied existing statutes todeemnwhtrteyaecpb'
of insuring the safeasoe pes and
disposal of recombinant DNA products Th sul
visions for preinanuf acturing or premarkeigapolqltycn
trols in manufacture, tetn of effecs eodepgadrprig
and appropriate packaging and handling.Wt.teecpin oe
above, the subcommittee has found surprisingly few obviosga i
these authorities; effective regulation,, however dped upothi
proper administration.
The subcommittee believes that Fedra creation hul ocso
the nature of the prospective uses of recobnt DNA tcnqe
rather than on the technology prse. It theefre mkslittlesee
to create a new agency or bureaucrc to regulate all activtein
volving recombinant DNA when exitn agece have aprrit
authority and exets in controlling a variety ofceialhzrs
insuring drug safey, creating wsedsoa n rnpraino
hazardous materials, andpefrigsmlrfnto.Thauo-
ity overpetcdlussoreobnnDN tehooysodr-
main with the EnvironmentalPoeto Aec.RglainoJhr
maceutical and other aplco ssbett h eea od rg
and Cosmetic Act shoul remainwihteFo nDrgAmhs
tration. 'The same reasoning applies to trasotto n ln n

preempt existing auhrte that r plcbet omrilue

trial ree rchativitietidne sniiie yto iia





49
the 7ood, Drug and Cosmetic Act, and the Toxic Substances Control
Act. With respect to commercial activities beyond the research stage,
however, the likelihood of overlapping regulation is much greater. The
subcommittee urges close coordination among the relevant executive
4gencies; memoranda of understanding or Executive orders may be
.G.".1ppKatwmethods of sortingout their responsibilities. Ile execu-
66e bianch should begin at once to make thesedeterminations. To the
Amtea-that reorganization of the executive branch eonsolidates juris-
diction*v r matters of health, safety, and environmental protection
Auth6tity over com'mercii al applicAdions of recombinant DNA should
a1w be wnsolidated.
1le subeommittee further recognizes that certain agencies may, need
t o: "gire expertise in recombinant DNA technictues and additional
ptrrunel and other resources. For example, the Environmental, Pro-
*6ticin Agency will likel assume much of the'burden. for screening
"&0ontroMig.re.bombinant DNA molecules and their use& Dqxnd-
ii!g. upon how raPidl the technology is developed, EPA should be
VVe41 sAffiti6nil funYs and manpower as necessary to administer the
,.Fhmlly"exi ting"stat-utory authorities should be used to the maxi-
mum extent feasibl& There is broad discretion in several statutes, in-
-eluding section 361 of the Public Health Service Act and the plant and
.animal quarantine laws to protect public health and, to an uncertain
,degree, the. environment, Careful consideration should -be *ventous-
ingthbise thoritiesto remedy weaknesses inotherFederaTlaw more
,directly f2u= to recombinant DNA applicatiom It is particularly
ithportant that. recombinant DNA organisms intended to -be released
t4e'en viroximent be subject to premanufacturing review and cer-
tificatibii that, tbey'pose 110 significant risk. If authority to accomplish
-thi.4 t 36eitio'nable. or, extensive litigation likely, CongTess should
,coiL6dj#:'nm#.'nc1ments to. the relevant statutes. The executive branch
-should m*ko the,. ge. determinations as soon as possible and propose
jilY To priate legislation to Congress.








... ... .. .. .












MINORITY VIEWS OF SENATOR HARRISON SOCflfITT
I cannot agree with the general thrust toward the excessive regula-
tion of a form of basic scientific research that is inherent in the ma-
jority's recommendations. The suggested risk cited for recombinant
DNA research is purely theoretical and hypothetical. This suggestion
is not supported by our knowledge of recombinant processes that have
occurred in nature since life began billions of years ago or by other
scientific considerations.
Many of the conclusions and recommendations made by the majority
are unwarranted and not supported by the weight of the testimony
presented during the 3 days of hearings held by the Science, Tech-
nology, and Space Subcommittee. Because of the debilitating effect,
that over-regulation of basic research would have on all science and
technology in the United States, the following dissenting -views are
offered for the benefit of committee members and others.

GENERAL CONSIEDEATIONS
At the outset, it is important to emphasize that the potential risk sur-
rounding research with recombinant DNA molecules was brought to
the public's attention by the specific group of research scentists in-
volved in such research. This was done at a very early stage in our
understanding of recombinant processes. The end result was the cre-
atiou of the present National Institutes of Health (NIH) guidelines
governing publicly funded D"NA research. This is an aspect of the re-
combinant DNA controversy that should not be ignored, for it demon-
strates both a high level of professional responsibility and the fact
that the system can work without unnecessarily restrictive regulations.
(See attachment A.)
Moreover. it is significant that some of the scientists who first called
attention to the conjectural hazards, after more research and after
consultation with scientists in related disciplines. have since reas-
sessed the situation and changed their perception of the risk. (See at-
tachment B.) 'rho NIH is presently considering' proposed revisions to
the guidelines that would have the effect of further relaxing the stand-
ards to take into account this new understanding. These factors dem-
onstrate the preliminary nature of our knowledge in this relatively
new field of scientific inquiry. -Any actions taken by the Congress or
the executive branch should be considered as an interim measure until
further information is obtained from which we can make an accurate
asszessmnent of the hazards, if any, associated with such research.
The use of recombinant techniques to modify fundamental genetic
material offers great promise for all mankind through improved under-
standinja of biological processes, and varied applications in such fields
as medicine, production of enzymes for industry. and agrculture. It
is now one of our foremost weapons in the search for an inexpensive
(50).






preenio orcr fcne sa lentvoicesnepnv
tm tm n t T he te t m nifiee ain s e "'iiiiiiiiii iii ~iiiiiiiiiiiiiiiiiiiiiiii e thatiiiiiii theiiiiiiiiiiiiiiiiiiiii' f irsti "iiiiiiiii

...... be eft ............. pr cia applications..... of recombinant....... DNAiiiiiiiearchi
are ==ot= far of an aeol h inin of. a vas inew caaiiiiiii
t========= boei mankiii. Major breakthroughs have already beeniiiiiii achievedii======iiiiiiiiii= iiii
with................. the.......... stu t r lg n st a p cf nin (u e te tm nto



dibte ndte rtinsmaotai, hc hsbendecibdb
Dr i~pHade, rsietofte aina caeyofSiecs

as "sienifi tiumh o th frstordr" ecuseof ts igifianceiiiliiiii
th udrtnigo tesrcueadfncino h eei
apparatus
I Neerteles, a wih ay ne fild f scentficreserch itii-
possbleat hisstae tosaywit abolue crtaity hatthee ae n







... i i, i i ............... ,,w ,, iii i ,, , ,, ....................... i ii~iiiiiiiiii ii!!!!i'~iiii~~~~~i i i iiiiiii ii~~iiii~ iiiii~ ii i iiiiii~iiiiiiiiiiiiiiiiiii!ii~~~ii iiillliiiiiiiiiiiii5 2i i iii i~ iiiii iiiii i% iii
regulatorystructure the majorii~iiyrpr goe tebodsin
polic aspct of the ise Wems drseealbodsinepl

'"" iiiiiiiiiiiiiii quest i before ii recomiii end iin e regulaion of.......an
D N A~ii~~iii~ iii~~! rese rch For example: ...................
-Wha isii te]matovriu eulto atraivso sine
and teelmologicai development and innovt~ion 1 HH
W h a t is t h e a p p r o p r ia teiii r o le o f tiiiii~ ~ i h ie n ifi c m m uit y o f t h
pbic, ofl theCogrssec. in h euaino ai cetfc
research?... i
-Whati ar the appopiat mechnism an orsfrfiiety
reso lv ingii co n fl ictsi a n d fo r m u la tin g sc ien ce p o licies!iiiiiiiiiiii~iiiiiiiiiiiiiiiii~ii~ii~~i~iiiiiiiii~~~ii~i~iiiiiiiiiiii~i~i~iiiiiiiiiiiii~iiiiiiiii~~iiiiiiiii i~~ii~i~ ~i~~ !!~iii~iiii~iii~iiiiiiii~iHi~ iH H
-To wha exen shoul thbi cpripaedetlinhefmu
i o n o f sciiiii ii~ii!iiii iiiiiiii N i p o liiiiiiii~i~i~ic a n diiiiiiiiiiiiiiiiiiiiiiiii w h a t sh o u ld b e tHH~iih e r o e o h e S a e
andi loca goernent in h frultono sc plcis
-T ha eg is hr osiuinlgaateo re =o

i entific,!i~ inuiiry an ne wa odiin ayi eabii
-Wha wi beii th osqecsofrglto nth ciiso
other ntion and on orcmeiv ecnmcpstonrltv o
them ii V! ii
These and othe qusion eaigt h oil eapltcln
eth"'ical ipicat i ofregulaingsinific reerh utbeadie


T oiii!iiiiiiiii~i~iii iii~iiii!!!!iii !iiiii~~! th at .......................... h a v e H H mH H in tro d u ced a ii b ill S.. 7 h i on l S i n e
PoiyCmiso cdsge opoieamcaimfracm
prhive,! 2-yer reseset clrfcto n!nlsso eea
scec oiie readn poni alyhzrosrsic ciiis
Une the ill a ntioa -cmiso ol eesalse o4fd





PREMPTIO
One~~~~ ~ ~ elmn fsineadtcnioyplcadacarl liiiiiiiii
6CF PPose recobm'at DNAle~aion, oncens th degee o
*ubliarticpatio in te poloymaing pocessiAtiisie iitheixten
Federal legisation hould reempiStateor i4aiiigovrnmen
tatin wih repectto rgulaed ativiies.The ajortyirport iii
OnM~e& a partal" edera premptin ofStateand.ocalreguatio
-Vhih wold i effct pohibt Stte o locl goernmnts rom nact
in srctrstndrs ht h Fdea Gvrnet nls "ov!e
j"10211 7 are how!
It he ubcmmiteeheaing, te sienifi comunty esiidiii
strngy n uportofth nedforFee remtio i ode t
ra Xit ust e rcogizedii
ackis nifm tanard. O tw oherha
thx An -frm f Fderl peemtio reresntsan.encoacmen o
tb rtBAStteaa ocl oemnetsad esrct te rdiioa
ht oftkepblic W at topcotct: he pblichealh ai safty. del
.2 iningpreesisnemsay o asue tatStaeshav te ihtiiiiiii
to e~lae eserc atiitis onuced itinthir orer wiiiiiiiiieii
4 % ,we tme vodin anumicesar pachwrk f cnficigiiii
loadnote, hatt~o cietifc cmmu

V gov"s et~cor~glag t
nity an ernentaappm to be cwkgr ot saisfctor iir
Po~etoub. oakeirown ae4 hey egonto enmunestewitheac

okii rator. htk cmfoat lt oher







ing to the use of section 361torglercmbntDN rsach
they ntonetheless recommend that teSceayo E gv h
most serious cosdeain promulgtingstnadudescio
361lif the legsltve committee onludethexsigahoty-sd,


ill-advised support to the use ofseto36torglercmbnt
DNA research in lieu oflegsain At ti ie mopsdt n
language in the report that might
siders section 361 to be appropriate forreuainorcmbat
D-NAreerh
The majority'sreomnainreadnseto36aesm,
what surprisinginsuhathaplcbltoftasauora-
thority to recominant DNAreerhwsntaubctoteha-
ings held by the subomte.Teol eeec ota eto

ogy Policy. Dr. Omenn epesdteoiinta euainb n
oekill There is nosuprintehaigrcdfoaplain


quired evidence that application o eto 6 ol eaporae
IL am not soinced.Infact i io e





rcombinant DNAreach
4i6 Asthemajrity row
corn in un-Iiii abeii diiiiiii~~iiiisaffcinghuman beinication to:
ps a s tnis o
C l e a r l y . ........... ....................................................... ............. b a s ici
scieniiiiiiii erc iviissc swt ecmiatDA upr
f r isi ~~iiii L i i i~ii ......u i o n c...................... b e.........................................................................................................................................................
agencyi~ Commie onRcm iatDA eerh ni rsos
from theCngesia Resarc Sr i(CSbtofwiham
that "no single legal authority ori cobinat~i~iio ofauhriie urenl
exist tha woul clal ec l eerci n te sso e

cobian DN eh ie an etal h euieet."(et
tachmentii D.)i i i
Moreover, tis some quesion astih plicaino eto




dence to support the posiiitio tha intasat reuaioni ees


Theiii Depatmen ofi~ HE assatdonsvra ccson ha t
prfr egsainadta teueofscin36 o eglt e
comin ant DNA!ii activities woui l d bei~i bothii''................... in p ri at andi~ in d




5
qw~~e,.(See attachii m ent E) Becuse o my cancer overthe pssibl
a p p ic a i n o f s e c t io n 3 6 1 1 w r o t e t o t h e S e c r e ta.................. .....................................r y o f H E W o n M a y 4 ,
190,&k o i iw ntescp n aueo uhrt n
clde unde sectio 361. = (See attachment..... F.)iiiiii"retiiiiiiirm liill
resomhasyetto e rceied
iiiiilie o sm la iq iry h i reto of OSTiiiiiiiiiiiiiiiiiacknowll

................................................................................................. iliiiiiD iiN A iiiiii e sii e a rciihm
col raepolm eas 1 i cnwegsasgiiatrs


of o comuncabl dieas, (2 itcretes recden fo
broad ntrusons ito th reserch evironentindi(3iit desino
appl tohazrds o te evirnmen tht hve o efecton uma
healh. See ttahmen G.
At he eryleat, pplcatonof ecton 61 o rcominat Niii
research ~~~~ ~ ~ ~ i woud.e...ec.....alchllng.iecton36ihsiee
emplrd n telpst.excusieb o rgulte now huan disease
orgaim aswe a knwn arrers f teseorgaism. Tereiiio
legal ~ ~ ~ ~ ~ ~ ~ ~ ~~ ... prcdniipotni6apicto fscio 6 oprli
hyptheicl rsk. Gve t omlexty f he sse, seof eci

861:is ikel togeneatelitiatin whch ouldfurher louith
stats o legslaive nd dminstrtiveeffrts
I Wnals concern abut he sopeof rgultoryautorit grnte
to te Serrtry o HE undr sctio 361 Onits ace it oul
to te Screaryunbrdle dicreionto pomugat an en
suchreguatios ashe dems ecesary andto tkeioherieas
ures neessry o crry ut he eguatins. her ar noappren
restictonsin he aw o th poer f te Seretry or re her
procdura reqiremntsthathe mst fllowin mpleentigian ien

........................................................... g j i a c t i o n b





6


Recent evets, however, sugetta nrae teto ilb
focused on teuse of scin31i iuo eilto.Bsdo rs
ently available information, it would be uws o hssbomte
to condone or support the use of suchindqaestuoyahrt
especially in such a delicate matter as the rglto fbscsinii
research. If there is shown to be a nedfrsauoyutriyo
ensure compliance with the NIH gudlnsby thprvtseo,
it should be accomplished byspcfclgsainersigthcer
intent of the Congress rather than uilaea cinbfh xctv
branch.


majority's recomnmendations which results nuwratdadecs
sivejegulain of a field of scetifcisachweete ik r

The consensus of the testimony prsneatheuboite erng
does not support such action.
ThUJe testimony presented at. the eing uprstepstohti
there is dIetermined to be a need forimdae eilto i hudb
directed solely toward extending teNHgieie onneeal
funded research on rcombinant DNA. 1gnrlyage ihta
conclusion, although I2 am neveteescnendta emgtiii
ate unnecessary and unreasnbersrcin ntecnuto ai
scientific research. Even here thegiensaralad iapid
voluntarily in th~e private setor. etil hr hof el hs
minimal requirementsneesrtoesrcmpicewhte
guidelines.
Based on m'y experience in the scienii omnt n h eea
level of professional responsibility demntaebyhesitsste-
selves, I cannot concur with the aoiyscnlsinta ytmo
voluntary comnpliane wolbeindqaeIdoblvthtsetss


wieldy system of regulations for enforcing thegudlnsOeexme








aeeshowing thi copiatc wthteNHgilnswodprvea

bin~orp~otedw





iii iiiiiiii iiiiii~ ii5i7
i.A.TACYEHEN Aiiii ,,

....................... m m

(B enr D ai*
Woryer aoagru o oeclr ilgit pbilyeprse
vk* ocenoe heptnil agr f eerhwihrcmit
DW nvltchiu htaloe ml|mon fDA h

M~ra o hchgns r adfom n ognsm obeicr
'tedint a rum.At teirurgig te Naionl I uie
of Helth ssuedan eaborte se of w~eliiesiforbddingtheiorma
tio o cetan knd ofreomin s nd laingvaiou rstiisiiiiiiii
on thes. ndlas spin Co sswasfrmin leisatin crrigiiii
additinal rstricions ad harh penlties
But he I i no conideing ubsantil rlaxaionof te gie
line~t~gresioal ommitee ar cosidring muh mlde le iiiiii
tio~i a~ te eedfo an lgilatonisincewngl qesiond.Itiiii/iiii
impot~ntto kow hy te dager see so uchsmaleritday
F%* Pepleforsevralyeas hve eenmakng ecobinntsiii
mapylabratrie, wthou a inge rsulingillnss.It s ceartha
thd editeddangrs eman entire h hetcal
Sowh, te rcombnan tehniue i inreaingy reognzedas








wide group of such experslssumranthygedtathepo

producing organims,whcarcutrdithuasofmialab
oratories every day.
Fourth, the bacteriabigueithswrarspcleknd
strains, carefully develo to rqientinsta r onon

sicidal: If the~y accidentallyinetdalbroywrkrhy vu
all die wthin a fe~w hours. ec eobnnsmd ihsc tan

have shownX that the chance of ecp ftercmiatgnsio
thesedyn baceria intoealthyonsi fnteiml
"Reomi t J4DN ir
versatiity.. . Wewill be p i ....
ate rest7ricio& that ae't justifd6 h aad.

DNA would have to be relesdfothhstbcrimankd
DNA, which would then have topnetahmncll hsrbblt

is less infectious tan the aeDAibetevrlcat ya uha
a miain-fth Rspreaidi any iic oplare









Spmeciicrally baatooftegilnsfr ibcterial e
multiplicatin nvrsrios ay u- yhi cunr tofalehn
of o feary att ion; i spoeae









vndeq that pti fea is-bse o the adiinlasmpintahs
reco m in a t w ul d bei an nti r l n oveli class.........................................................


enonee eoei aue ih ute icsinti sup


tinhsbcm xednl nikl.W nwta atra a

tae-pDA(huhifeunl);adsnebceioaebe


grwn ntecln foracsor o iloso eri svr



tull certai ........ thyhveotn.ae .u.u anDA.rlae






59
Hence splicm-g, DNA from a distant source into -a bac.
MMOT:ros; at all liliely, to produce a well-balanced, competitive set
9f gtuqf Any more than mserting a random radio part would be likely
to 44prove a watch.
Witkthese developments, the initially very cautious attitude of the
maen e. community has shifted dramatically. The bluntest critique
has come from James Watson (who triggered the development of
naleclilar biology by his discovery, with Francis Crick, of the struc-
fumof DNA). Though he was one of those who first voiced caution,
lwapw urges that we abandon the whole expensive bureaucracy of
guidelines and release the wasted time and money for solving real
health problems. It seems almost certain that Watson will prove righ .
But-meanwhile it also seems clear that public anxiety, generated ini-
tiaUy by, scientists, cannot be reversed until the trtie nature of recombi-
nant DNA researchis widely understood.
The recombinant DNA story illustrates a broader problem: how
tq. handle public policy issues that have a large technical content. If
We: wish to maximize beneficial research, without jeopardizing either
Public welfare or public confidence.,, we must find ways to work out
more clearly the role of the community of experts in ascertaining the
fketsas objectively as possibleiand the subsequent role of the broader
public in making value judgments and policy decisions. For while
the'public has a ri lit to know, it also has a right to be protected
from false alarms. T useful model may be that of the medical pro-
1060A, -Which often has to consider alternative diagnoses:in a case
UA also exercises discretion in avoiding premature discussion of un-
proved possibilities that would unduly alarm the patient. Perhaps the
smotifie, professiow and the public are groping for a similar code.
ATTACHMENT B
Tux NOBEMST vs. Tom FiLm STAR
RESTRICTIO!"TS O,%T DNA RESEARCH ArrrACKV.P
(By J. D. Watson*
Um1fl the last year, I never thought much aboutmy allegiance. My
parents wen -for R6osevelt and against the spoilage of our land by
asnsel6ss land speculators or industriiial Fi" who put steel mills where
Uwe had'been sand dunes and the pradrie warbler had nested. People
'who went on bird trips or camped in the national forests and wanted
to save Mineral King were the right sort, while those who owned
big yaehts or stripped the rolhng fields of Ohio for coal were'the bad
gitys whom we must get laws to stop. So it was naturial to make out it
modwt check wheneirer Robert R edford, or' some equally fine fellow
asked you to hel him defend the environment and fight the polluters
whemould give us more chance
Now.' however, I must confdss: that I didfi't respond to Robert, Red-
ford's latest appeal. It is not that I am against him as a folk hero,
but, though he must be unaware, he and I are, for practical purposes,
real enemies. For some of the money be raises for the Environmental
*Watson, director of the Cold spring Harbor Laboratory In New York state. won a 1962
Nobel Prize In medicine for bin work on the structure of DNA.










powerful means to find out what human genesarlieAn s

genes that go out of control when
This being so, I most certainly am a Fin fDAadwn
work with recombinant DNA to this impulse would geerally be viewedasgofrtherh.Nw
however, there existhihyvclgopwhthnI'adnero
the world. The Fred of theEarh the SirraCu n h aua
Resources Defense Council, as well as teEniomtaDens
Fund, all say that our experiments poearelsithatoouwy
of life and must be constrained by their
lawyers.
All this initially surprised me, since I hdawy eaddevrn
mnentalists, as among our mostinelgtpuicrosadthgt
thalt the original rub for work wt eobnn N hc
had come out of the 1975 Asilo
assure them. Particularly ie
overkill and probably not at all ncsay
My fellow DNA workers wnehowvrpoatmoeta la
and certainly to give the impesoofbigrpnilectzs.S
they sgetdta elreywr ihseiial nebe ra
ismis that would not live well outsd u ettbs n hn fe

Health, they in turn wanted to lookaike h efc urino u
health. and so the guidelines which we now have toliewtbca,
more than tough. In fact, they effcieybokdmsofteetr
experiments that directly rlate to cancer.
As a result, the DNAcomntisnwvruhap rdg
under harsh rules we do not beiee neesr n hihwsevs
sums of sorely needed reerh fuds. We nowwatorexgetl
the guidelines we imposeduo oreves






aerried onstea he oer isav idnecuadnesic


<4 2
thr aadsilintataeo vdneta n ftee






61

j ugate the masses by giving, them bad genes manufactured by re-
combinant DNA methodologies. This is a mad idea which I suspect
the an toointelligent really to believe. It must be a tactical move
in I rir zany campaign to convince the Boston poor to rise up against
the elitist iinperialism of MIT and Harvard.
We neverexpected, however, that we would be branded as polluters
b1the environmental movement. For until recombinant DNA came
a Ong, we always thought we were on their side.
After all, Who wants to see our planet not fit for our children to
inherit? When they went to court to block DDT or keep the skies of
Moniiment Valley blue, we could only applaud. So why now are we
on opposite sides? Can we have on blinders, and can our self interest
as scientists not allow us to see how indifferent we are to the harm we
may do I Might, in fact, the professional environmentalist present
argunientsthat t can7t faze up to 1
- I feel stron' Llwy etris is not the case. Compared to almost any other
bbjed which starts with the letter D, DNA is very safe indeed. Far
b(tter to worry about daggers, or dynamite, or do or dieldrin or
410Ah or drunken drivers than to draw up Rube &Idberg schem'es
on'how our laboratory-made DNA will lead to the extinction of the
-Tlit. straits of viruses and cells we work with in the laboratory
g6n e rally are not pathogenic for man, and 0 we know about infec-
tions: dii6ases makes it unlikel that the addition of a little foreign
DNA *ill create agy danger Tor those who work with recombinant
I)VIA-bearing. bacteria. Even if no special guidelines existed, and we
,y. Mployed the standard microbiological practices of routine steri-
lixkti* we should have no reason to be concerned for our health.
Eju Llly important, we should not worry that our experiments will
Yjr 6&&dly alter evolution 'by creating Mum life forms unlike any
iwa before., DNA is frequently carried froin one species to another
by. Vikuse,4, mid the global evolutiom W.Pact.of our experiments
must be negligible compared to UStUM9 Zi 1 om'rringr DNA transfers.
If this is so, how can we explain the en siasm with which so many
profemional environmentalist Wish to shut us down V
The answer, I fear, is that such groups thrive on bad news, and, the
More the, Public worries about the environment, the more likely we are
to keep providing them with the funds that they need to keep their
organizations growing. So if they do not watch themselves, they win
always opt for the worst possible scenario.
For the short term this mav give them more recruits, but 1. worry
about the long-term effect. go one win benefit if we perceive the
credibility of our environmental movemelds to be no better than that
fthe most troglodytiq of our industrial firins.
U what thev say about DXAiq nonsense, do we have anycompellmg
X wm.,.to listen to.0,em when they come out against pis4eide-s that
shiny les or, tqflus.-that the watm of
'&PP ; the Wasmpw a;*
J&ton
Mywto give.us.. cancerl I would Ue so e su h
u4ftors but whom t: rust n0v is not tha














ATTACHEN



(Byhior Benrc).Dvs



but its direction is domtinatedi by ntrlslcin ti rmtc o


ucts of evolutionary experimentation~ suvvters big*tls




nore anT oganism bes efetiv nteDrwna optiinti










om gena counsoe (Seter aped to the wevrnet nlslc
iommte.) Thcoe Subectontteald.et~o
band nJnary 11 gn Febrarae ordcaesat9iTielce






63

The &ibcomniittee was charged to determine whether existing
I *sla ive a rit wo permi e regu. on of rvewawom. t
the-United S (w ther or not Federally funded)
=&.Wouldinclude- at least th ow*,. regulatory requirements:
(1) revitw of su& research by an institutional biohazards
ammmittee before it is undertaken,
(il) Compliance with, physical and biological containment
and prohibitions in the: NIH Guidelines,
(3)'. registration of such research with a national registry at
the time the research is undertaken (subject to appropriate safe-
guards to protect proprietar aterests) and
(4) enforcement of the love requirements through monitor-
ing, inspection, and sanctions.
It was tbeconclusion of the Subcommittee that present law could
permit imposition of some of the above requirements on much recom-
binant DNA laboratory research, but that no single legal authority
or combinition of authorities currently exists that would clearly reach
all research and other uses of recombinant DNA techniques and meet
MI the requirements. The complete Subcommittee a0alysis is included
Ift -Appeadix IH. The Subcommittee, in reaching this conclusion,
reviewed. the Iollowinglaws that were deemed most deserving of
d6tailiad b6nsiddration:
(I) he Occupational Safety and Health Act of 1970 (Public
Law!DI 596)9
(2) the Toxic Substances Control Act (Public Law 9"9),
% 3),'the Haiakdous Materials Tramportation Act (Public Law

.(4) Section 361 of the Public Health Service Act (42 U.S.C.
264).
',T Occupational-Safety ahd Health Act gives the Oeeupa;tio al,
Safety and Health Administration. (OSHA) broad powers to require
whployers to provide a safe workplace for their employees. The term
employer" in the Act however, is defined in sudh -a way as td exclude
Statesairid their political subdivisions unless the OSHA standards are
oluntarily adopted. Twenty-four States have adopted the standards,
hut t*ezity-six states are not subject to them. Further, the OSHA
standards do not cover self-employed persons. For these reasons it was
determined that OSHA at present could not regulate all recombinant
DNA research.
J The Environmental Protecticol Agency, under the Toxic Substances
Control Act, is directed to control chemicals that Tay present an
"unreasonable risk of injury to the health or the environment." The
Subcommittee determined that'the materials used in recombinant
RNA research would appear to be covered in most cases by the Act's
definition of "chemical substance." Section 5 of the Act, however,
explicitly exempts registration of chemical substances used in small
T titles for the purposes of scientific. experimentation or analysi&
hT represents a most serious deficiency, as the registration of activ-
itids was thought to be an essential element of any regulatory effort.
Also, in order to meet the specifications of the Act, recombinant DN.A.









reseciwoely, aveort to b on opeet"nuraoal iko

injrEW to elatrte enionmnt.
The HazarAct. (te TiTion ist mcA in


ism th e




mesetiell futho rityt euae h hpeto aadu aeil
initrae Sucommere. Blot thieDOanthC ,inmpenig
the3 oft th IspAct bt tisgi prodcs aveesnilyamda

Wante ollting ororlato ofalreobnntDAreerh
ifatalltorelate reofbnn DNAmb reercD n deAeton31o



committee calthough treise ehisstin, whciuire t orgn
isstaarcomncbeadcuehmndsaeThune thi
secinthrwudhvto-earaoalbaifococuigta
t h e ... . .. .. .. .. .. .... .. .... .. ..... ... .... .............. . . . .. .. .. . ... .. .. .. .. . .. .. .. .. .. .. .. .. .. .. .. . .. .. .. .. ... .. .. .... ....... ........ ..
e sand.ar comnce.t ute, eto 6 osntapyt
pati mas or th.gn....nirnm nt.t.......ncusono
teSucmitetaSeto36lakdterqiltatoiyo

mental h eurmet e o h euato fti eerh
Th Subommtte alocosdre....toit fth D ti
c e s .. ...... . . .. .. .. ... ... ..... ... .... .. ........ ....... ........ ................. ... .......................................... . .. .............................. .. .
353 of th cbtti rvsonwsntcniee ob p
plcal torsacaoaoi s
Ote uhrte fEAudrteCenArAt h eea




Wa e olto oto cd teRsuc osevto n e


6oeyAto 96wr osdrdbifyadtogtol oapy
ifa lt sltdapcso eomiatDArsac.Tb'atoi







MaF, LmmARY Or CoNGPxss,
CONGRESSIONAL PLESEARCH SERVW];
Va8hington, D.C., May 12, 1978.
To: Hon. Harrison H. Schmitt.
Fitm.- American Law Division.
Sub'ect: Questions concerning the applicability of section 361 of the
Tublic Health Service Act to recombinant DNA research.
The following memorandum has been prepared in response to your
several, questions regarding HEW's regulatory authority under See-
tion 361 of the Public Health Service Act (42 U.S.C. 264). Speci-
fleslly5 you have requested our opinion as to the regulatory scope of
Section 361 andits applicability topublic and private rewinbinant
DNA research.
'Initially we must agree based on our own extensive research, with
theFedeiral Interagency 6mmittee, on Recombinant DNA. Research
that 1 no single legal authority or combination of authorities curren ly
exi t that would olearly rearh all research and other uses of recombi-
ntnt bNA techniques and meet all the requirements." In a, paper we
prepated last December, we came'to the same conclusion:
In brief, comprehensive regulation of the products result-
ing. from recombinant DNA research techniques does not an-
-pear feasible under current laws. At best. re-aulation wili te
piacemeal and dependent on theuses for w hiA those products
are intended. Regulation will be dispersed throughout several
federal agencies, where the research activities involved come
under the respective department or agency mandate and it
will be limited by the purposes enumerated in the appropriate
authorizing legislation.
Several of your questions deal with Section 361 (42 U.S.C. 264).
Whfle it can certainly be argued that section 361 does authorize the
Secretary of HEW to promulgate regulations to protect the public
from the introduction or spread of any suspect communicable disease,
thus authorizing the regulation of recombinant DNA research, it is a
highly disputed interpretation of the section. The section, on its face,
refirs to the prevention of the spread, etc. of communicable diseases.
AAuiittedlylhe language of Section 361 (a) is rather broad. However,
spbeifio, ft-tutory limitations in subsfttions '(b) I (a) and (d). to 11dis-
easm 49 1 M&V be 8 L ffi d" and to the Control of interSt&te andforeign
travel Of infecte persons, suggest that control of private intrastate
rel*irch, to aware ction of, the public and environment fTom. un-
kAo*n- dangers and unspecifi6d diseases may well, be Outside the-scope
of the section. It ftn hardly be argued that Congress intendedl-when
theoriginal qiiarantine law was enaoted,'or superceded, that this regu-
latory authority extended 0 research which is just now becoming feas-
i-h1m While there is no doubt that Congress intended the 11 ropriate
federal authorities to have broad and flexible powers (i.e., Mt use of
com*entional public-health enforcement metliods" to, prevent the
sPread of dangerous and destructive disease, it surely diA not mean
that scientific research was to be pervasively ragukt4.
I Orig ..... ly enacted In 18T9 (Act of Mar. 3, 1879), superseded In 181)3 (27 Stat. 449),
and In 1944 (58 Stat. 703.).
s This language is f rom the House report accompanying the 1944 amendments.







There are few decisions of the courts in whichthspulceah
tescope of section 36i1 do -no prvde convicn uhrt o h
belef hattheSecretary's powers udrta eto r sboda
they must be to accomipfih pervasivereuainorcmbatDN
research. The most recentcaetcosrescin31wsdiedlt
Year by the federal district court in hesendsrito eusaa
otuiina v. Mathes 427 F.Supp.174 (19I .TeScrtr fIE
had banned the intrae and intrsae aeo l ml ute eas


high (54 percent orgreater),that"atotal is

testing shm. hl nitatt a a emdncsay n
the courtsacindrgltotopeettepsiiiyosra,
municable dies alreadyspcfeintefdrlegaioMweI-
volved Thus, the~ Secreary' regular auhoitywil i omass








extend to inrsaergltoofptnildesbut th0aede
not su~pport the cnclusionta hsiptu nalcrcmtnepr
ticula io involving e
eases.' We foun no caesupprieo h oiintayohtcl
dangers anddiessaewtithscpofston31

and the possible sra frcmiatDAgnrtddsae h
courts may choose to give section 361 exa
pretation that was applied in L a
sidered however, that the court have notyedalwihtsan
litigation would inevitably reut fromexnsoofecin31t
recombinant DNA rerc. We havereiwdteltrofJnay6
19 78 f rom Peter Barton Hutt to Glbeo .Oelan ercgi

clude that teSertr'reuaoyatoiyudrsctn36iss




howdever. ~t ths ggssnteeetta e eilto opo
veten it fo DA regulation s oeeme i a a t

atirosefeiv ians to regulate, the cd ormn D
research.i
Adiiitioal youi~i~i!! haease orlga rceet uprtv o h
usei! of secion36 to!! reglt obweilornn lrsarh h
Drinln Wate Stadads set ou t4 ..2.0 eieplu
tion l toiii meani th rsneoiayfrin usac"icuig"r
ganic iricrdooiaorbooia"poucsta!a Cn


siueahzrorii h sfleso h ae. urnl
howeve,i i these.i stndrd reth ol oespomlgte ndr h
Publiiiiic HelhSrieAtwihxedbyndbceilfnao
viarcktsa and..... chlamydia etigic agents.ii~ Se,4 ..R 22
(a) (c). We are aware of no court case that has dealt with the furtherii!ii~~iii! iii !~iii~iiiii
ex ten ion o th es regui~ ~ii~l at !ion to..........................................................is m s
and l thir toins.





.~ ~ ........ ...%MtoteSceayspemeatotyudrscon61'"h
3 pow of C on gress is the ultim ate touchstone." R etail o k V.
iiiiiiiiiiiiiiiiiiiiiiiiiiioiiiiiiiliiiiiiiiiiiii37 5 iiiiiiiiiiiiiiU.S iiiiiiiiiiiiiiii 9 6i, 1 0 3 ( 1 9 6 3 ) A n e a r l y S u p r e m e C o u r t c a se
...................................... u p h e ld a sta te 's q u a ra n tin e la w s (a lleg ed to b e in co n fl ic t w ith .......................................................................iiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiii iii iiiiiiiiiiiii
federl law, staed tht "qurantie law belog to hat cass o stat
legislation~~~ ~ ~ ~ ~1 whchisvai...i.dspaedb..nres.ad.ha..c

J. ri~atin hs ben xprssl reognzedD~y th las o th U iiiii
4ts lms fomte egnin o gvrnen. Cmpg i n

... a v Loisiaa Bard f Halth 18 U.S 38, 38 (102) Loii
anav, ema,17 U.. 1 21 189).In nacingthefedralquaan ieii
las(sbeqetl uereedb scio 6),te ogrs apr

.entl~ ~ ~ ~~~~~~~~~~.. diioixrs pcfcitntt rep tt aso h
Te ect. he Suprem Court.ha.stated.tat."we.strt.with.te.......
tin ta tehitrc oic owr f h Saeswr nttob spr
seded by he Federa Actiinlesitiatiwsitheicleriandimanfest iiii


whether.... it iniid topeeptsaelas n i uh i

stances,~~~~~ ~ ~ ~ th........al.ssti.lca..glain n h
samesubect attr ulessit onfictswit feeral la -o



woud fusrat th fderl chee, r nles te ours is- iiii


cenfo!tettltyo h ircmtne htCnrs








868 (a) of the Act which providsta n esnwovoae eto
361, et.,6shl be p hd y afine~ o o oe hn 100O-
impisnmen~t for not more than one~ year, or bt. rsnlijm
tivereie for violations of scin31i o pcfclyatoie
under th P~ublic Health Servce At.
Beas of the constraintsof timne-wearentabeoprvd
dtiled cmarison of the Secretary's authrt ne eaeAed
mentt 1713 and H.LR. 11192 with the poteta cp fhs-uhrt
under section 361. It is obvious thoughthat une hpndn'iis
lation the Secretary's authority is subjctolsdipeancery
is more encompasn hni ol e ne eto 6.Tepoe
dures for inspections are set out by Congress in tpn gli i.
Should section 361 be used for re ltion hnHWms eeo
its own procedures. Preemption wiIbeacopihduertand
ing legislation whereas preemptive capacity udrscin31i n
likely to exist. Injunctive authority is as lal rvddfri h
pending legislation. Furthermnre, the-prvsointepdngli-
lation for a study of DNA research and isapiainscudb.se
fu~l in providing guidelines for future reuatoofscanead
unprecedented area.
We hope that this information will be hepu.I ouneAdi
tional information or analysis please feel free tocalous


Doru~8 ON NAC.IRRT'



To: Hon. Harrison H. Schmitt (Atn ilGb
From: American Law Division.
Subject: Appraisal of correspondec cocrigspefauhit
Under the Public Health Service Act.
As you requested as a follow up to our mmrnu fMy1 e
garding the use of section 361 of the PulicealhSrieAtt
regulate recombinant DNA research, we hae mr aeul e
viewed Mr. Petr Barton Hutt's letter of Jaur 6 oD.Gibr S
Omenm, We expressed the belief in orpreiu o eoanuta
although _Mr. Hutt's arguments appear~ to have som ocw ol
not reach the very broadadgnrlcnlsoshdibse'nou
interpretations of eitn tttr n aelw o ae se
ustoela.borate on that poito by adesn eea atclrcn
clsinsexpressed by Mr. IHtt in hiletr
First, you haveaked us to analyze Mr. Ht',psto bu h
application of Section 361 to intrasaecm re.M.Htsaeso

tion banning alsmall pettutefrmbtinastefi-lesae
commerce under the sole authoiyoSetn36.Inhelspa-
gahon p~efour, lie fthersttstathcorinLusaa
"rldthat setion 361 permits FDA to control nrsaeswlls
interstate activity."





69

flvvlr o&"*n idnthldta ecin36 emtsFAt
co I ntasat atiit i al irumtace. hecortclary x
pli~ne~tatth itrsat bn asjutiie nl bcaseitwa ne



essrytoprven te ntrsttespea ofdieae.As hecortex

Rlaied7 he FA reulaton ws du to he "artiularfactian
circustanes unerlyng th banon tutlesiwhiciarenotipesen
iniiallieases.'
With efernce o DN reserchther is o eviencetoisppor
thepostin tat ntastte egulaio isnecssry o pevnt hei-iiiii
tersate prea of ommuicate diease Anyhazadsiaisinifro
recobinat DN resarchare t ths pont i tim purlyisecul
tive Mr.J. D Waton, n emnen autorit on NA, ecenlyiwote
[I~n ur oigina staemens abot reombinntiDAiw
kept~efering o "ptental dagers" Inteadiweihoul
havesaid"conectual dnger," incether was andstiliis
not atrac of videne tht an of he exerimntsiosei
thret tothos whodo temmuchlessto te geeralpub

The srain of iruss an cell we ork itiinithilab
oratoy general ar notpathgeni formenandilliw
know aout inectiou diseaesimaesiit nlikelithat he ad
ditio of litle freig DNA ill reatiinydangriio
thoe wo wrk ithrecmbnan DN-berin bateia. ii
E ' n i no pecal uideine exsted an weonlyempoye
stanxd icrbioogicl pactcesof outie seriizaion
we souldhaveno easo to e cocered fr ou hiiih.


Therfore whie weagre wit Mr.Huttthatintrstat comerc


cetanl my e eglte t pevntth sradofcomuicbl ds





70

eral cases a strong commitment to the principles of academic and intal-
lectual inquiry and a presumption against governmental interference.
Tn testimony last May before the House Subcommittee on Science, Re-
search and Technology, Professor Thoma's 1. Emerson of Yale JA&w
chool expressed his belief that at least, some aspects of recombinant
WNA work must be characterized as deserving of First nendment
1 protection:
The first question is whether the conduct involved in
D-N-A research constitutes "expression" or "action." It seem
to me that the development, or exposition of theoretical idme,
about DNA and other genetic materials and processm is
clearly eq-)res zioli. Siich conduct involves the search for truth
in its primal form. The fact that the researcher works physi-
cally with comj-- ].;cated equipment does not deprive the Con-
duci of its character as expression. In similar fashion a tek-
scope is used to study the stars, an accelerator to study nu-
clear particles. a T)ul)ll'c address system to carry on a public
meetipg. aiid r --.erox niachine to make copies for distributim
The more difficult question is the classification of experinien-
tation. Experimentation is a vital feature on the development
of new information, ideas, and theories. This is particularly
so in the physical sciences. One must cc-nelude that it is often
an Integral part of scientific research. that is, a part of the sys-
tem of freedom of expression. Analogous conduct is the-
i-narching in a demonstration., the publication of a newspaper,
,"Ond organization of a political party. Although all, such
eonesiirt involvez -mori- than slieer think -ng or verbalization,
-nevertl-eless it is an essential feature of a system of free
expression.
On the other hand, at some point experimentation clearly
Tnoves into the realm of action. Just as political assassinatioii
has an elepnent of expression but is basically action, so an
experiment to rest a theory of nuclear energy which might
blow up a city, or contaminate. the atmosphere of the whole
world, is also predominantly action. The line has to be drawn
on the basis of all the facts, In a part icula-r case and -in I*ht
of the proper function of a system of freedom of expression
in a den-iocratle societv.
On the basis of present information available to me it is
d iffir--ult to state more specifically what forms of experimenta-
tion should be classified as expression, and what as action. It
does seem clear, howcver, that experiments which pose a seri-
otis tbreat to the physical healt1i or safety of a community,
inust be classified as action. Such conduct is analogous to the
use of violence a a--ainst Persons or property in a demonstration,
or the throwing of rocks tbrough the windows of the White
House. The pb-vs1cal element of the conduct is the paramount
cancern. and the conduct, therefore falls into the realm of
action rather than the expression of ideas.
On this analysis, the broad search for informaiion about
D"-\'A. the foriniiiation of hypotheses, the exposition and dis-
cusslon of tlieorios and nietbodg would constitute expression,





71
Atid, be fully protected under the First Amendment. Thus the
g6vernment could not prohibit, regulate or discourage in any
way DNA research on the grounCthat mankind ought not to
'be: pursuing ideas about ways to develop new forms of life..On
..the other hand experiments that presented a sub8tantial and
8erWU8 danger to the physical health and safety of the sur-
rounding population could be subject to regulation without
infrin the oniarantees of the First Amendment. Only the
requirements of due process, equal rotection and other con-
stitutional provisions would cable to such regulation.
[Emphasis added.]
We. are thus confronted with the additional problem that the pro-
posed regulation may result in stifling the freedom of scientific in uiry
!Using the framework developed by a noted constitutional law WTolar
at Harvard, Laurence H. Tribe, government regulation of DNA re-
search might be described as being "aimed at noncommunicative im-
pact but nonetheless having adverse effects on communicative opinor-
tun!ty.11 3 Government action in a case of this sort requires thelbal-
ane ng of competing interests. According to Mr. Tribe, "regulatory
cWces aimed at harm not caused by ideas or information as such are
acceptable so long as they do not unduly constrict the flow of informs-
tion'and ideas." 4 Presented with this difficulty should DNA research
be characterized as having constitutional implications, the courts may
be unwilling to uphold the use of section 361 for a purpose not clearly
intended when the law was enacted.
Although there is little 'Legal authority related to this problem, a
recent case involving the Federal Communication Commission's reg-
ulatory authority over cable television suggests that agenjiurisdic-
don, even when its mandate is broad, is not without limits. ome. Box
00ce, Inc., v. FCC., 567 F2d 9 (C.A.D.C. 1977). In that case, the court
was faced with F.C.C. regulation of cable television under the Com-
mumeations Act of 1934. No provision in that Act authorized such
ation. The court citedSUDreme Court preedent sanctioning the
r119 able television "but only where the ends to be achieved
were 'long established' in the field of broadcast television or were
'congressionally approved"' Id., at 13 (citations omitted). This con-
cern was of particular importance because of the First Amendment
implications involved in regulation of the media. In an even more
recent case, the Eighth Circuit also struck down F.C.C. regulation of
cable television. Midwest Video Corp. v. F.C.C., 571 F2d 1025 (8th
Cir.,:191(8). The court expressed gr ve concern with governmental in-
trusion in areas affecting the exercise of -Constitutional rights:
Though we find it unnecessary to resolve the serious consti-
tutional iffi'ues raised, we do bold that where, as here, potenr
tial incursions into sensitive constitutional rights are in-
volved, careful scruthky 8 required in delineating the goope.
of authority Congress intended the age-ney to exerci8e. Id., at,
1052 rEmphasis added.]
American Constitutional Law, by Laurence H. Tribe (Mineola, New York: 1979 p.
58&
4 Id,,, at 581-582.










































use






73......
tiaml ifrtpowr, rr ie iiniunity; .... exes ofsattr

jurisdiction,............ auh riy or li iaino hoto tttr iht;iii

oriwihouiibseiinceifiprciduriieire ylw"Se ~. Loi
ana Mthe8 fr anexapleof pplcatin.o.t.stadar Clearly==ii
these........d...s...r....uch.d.i....rent.f.ro m.a..t..t..to..................her
. W Y a t o i s h l y i r t o ...................................................."i
Firalyyo hae skd orlegl reedntwhih upors he iiliiiii
folwn ttmn rmpg i of Mr.Hut'seitr:Alltha
is' neddt upr eultosudrti!rviiniihrape

henson r unertintyabot th posibiityof ptenial armiii
lackof aequae inormaion howig thi th har canotiocur
an te osibliy ha te ar oud e erou (g. ireeril
if id ccr."Tht sanardisnotfond n he tauteori the.....
reguatios pomulatedundr it Norhasany ourt toour nowldge
appiedsuc brad anuag. Crtanlymoe i nededtha i
"th lac iiiii ad qu t iiiiiiiiiiiii iiiiiiiiiiin i tiiiiiiiiiiiiiiii thei h ar .......................... oc u r






74

of recombinan1t DNA researhadrltdatviis epne.t
questions dirce to the Foo n rgAmnstainaeas n
cludedintileer
1. SectinI 36Z1 th Public Hedt Sevc c
Section 361 authorizes the Secetary ofH Wt aeatoope
vent the introduction, transmiss, and se of comnial di
eases from foreign countries and from Stt$ oSae h neaec
Committee on Recombinant DNA Researheaie eitn as
including section 361, to determineif they rvddaeut uhrt
to regulate all recominant DNA actviesThComtecnlud
that new and specific legislation wasned.
The Committee's report (a copy ofwhciselod)read
March 15, 1977, contains the followingcoluinoceigsctn
"Section 361 could perhaps be interp
legal support for more comprehensive rglto.Hwvr nodrt
do so there would presumably havetobaresnleaisfrc-
cluding that the product of all recombntDN reachaueo
may cause human disease. Such a conclio woududutdyb
tenuous at best, and it is unlikely that resutn reqireetcudb
effectively imposed and enforced."
On November 11, 1976, the EnvironetlDfneFn n h
Natural Resources Defense Council filed a peition wt h ertr
ofUHEW askn him to imps regultosnalrembatDN
activities, citing section 361 as authority (see AppniIVoth
Interagency Report). As explained inthipeton(ep.5-9)
they argued that the definition of cmuial ies ne eto
361 can be read to include all recombinn DNtciiis
The Department has used section 36 orglt anme fpo
ducts which affect human health, incluigselih e utepi
mates, milk, drinking -water, and human blo.Or OfcfteGn
eral Counsel, however, believes it is prefealfoargutryfot
of the mni~gtude required to oversee al eobnn N ciiis
whether or not known to affect humanheltobbadonhexpit
support of the Congress as well as tha of h diitain atc
iilaiy n light of the active interest the Congress has shown inthisarea.
The consenss needed for this type of prgaisntbtetblhd
by applying a general provision of law toqhsseiicstain
2. 0Ot herHEW Autkorities
The Food and Drug Administration (FDA) srsosil o s
suring that h~uman drugs, biologics, medcldvcsodcseis
and animal drugs, are safe, effective, and are proueincfrmt
with good manufacturing practices. For all nedrgnwail

vices, the sponsor or manufacturer has thebudnodensrtg

eral Food, Drug, and Cosmetic Act requie auatrr fsc

itrFDAte omere.i and ad
interstate commerce. Q
The FDA has response ibiityt aeur h ubi rmalptn
!!ia hazardsi that! mayreslt i mteieeometoipoutita r







75


su~bwt o te Aencys jrisicton. hisautoriy wold xted t
research....n....u.a..e..pr.d.cts....... r c in.......................................................A is in volved .


Th Aeny oud ude eisin utorty rqur ay ir sekn


ap Ma o pod ctw ihiiiiiiiiiidiiiictofiecmbian
DRAreeach o erifytoth Agnc tat t ascomlid ithiiiiiiiiiiie






Natona IntittesofHlh (I udeieso rcmbnn





76

writing rule more retrctive than theexsigNtoaIniuesf



Healh gulins
the guidelines approved severalimotnchgenlungap-
posal to delegate authority for in a
experiments from the NIH to s uti
would still be reviewed by NIH, bt cudbgna ona oa p
proval was obtained, cutting bu
The NIH committee also proposed reduing e
to much lower containment levels
If Congress fails to pass a bill, teAdminitaonwlthnav
to choose between continuing the present apprc of volutr d
herence to the NIH guidelines, and invoking eitn ea uhrt
to give the guidelines the force of leiltion. ahcoc a t w
advantages and difficulties.
It is far too early, however, to rule
bill. The latest move by Kennedy s
it may seem. Although it is ascribed by aides to a change inKend'
perception of the hazards over the last 10 months, Kneyhsawy
seemed to be less interested in the possible rssof thiereachtn
in the principle of allowing the public adlclatoiisaviei
decisions about research. The bill pending in the House
has strong general support from certain senators,
role. Probably not having the votes to defeat pr
Senate, Kennedy's staff may hope to obtain the same edb ncin
Those who favor preemption, such as the NIH adteAeia
,Society of Microbiologists, may therefore press fo a Snt ilt
be passed. Other interested parties, such as SntrAliSeesn
may also favor aSenate bill if the Admnsrto elnst s
existing powers.
Where matters now stand is that, at a of s i
Senate human resources committee on 1 May, itwadeidthtKn
nedy would write to HEW Secretary Joseph Glfn oteefc
that legislation seemed unnecessary if the Admnsrto eePe
pared to use already existing powers.
Calif ano's response is hard to predict because the thouh fn
legislation at all is too new for people to havedeidwhthy
would like to do instead. Nor is the Adistaonllfoemn.
The NIH favors'strong preemption, believing that a la witotpe
emption would be the worst of both worlds. For this, amogohrra
sons, the agency is~ lukewar m toward invknexsigatote,
such as Section 361 of the Pubc Health A
Secretary of HEW sweeping powes toc
but not to preempt state govermns
Other parts of the Adminis ion, eo .
House staff, are not so hot forprempion an4ol iewt eto
361. As the result of an internalcopmie I drctrDnl
Frederickson recently testified in support of awekrfmofp-
emption than that stipulated i n the House bil
"It is our judgment that many aspects we dsr ol eahee
under Section 361," says Gilbert
dent's science -adviser's office. But hie also notes that volutrcopi
ance has worked well.





77
Kennedy's letter to Califanowill probably ask, among other things,
if Section 361 is an appropriate vehicle for regulating recombinant
DNA. "Our response will be that simple legislation is required, and
that 861 is not an appropriate statute," says an NIH official. In the
NIH view, the section does not explicitly offer preemption although
some legal opinion holds that it would do so in pi-actice), use of the
statute might imply that recombinant DNA could give rise to com-
munciable disease, and in any case Congress should carefully fraine a
special new law if it wishes to take the step of regulating biological
research.
The problem of how to govern recombinant DNA research is as far
from certain solution as ever. but the present range of likely outcomes
is generally much less restrictive than those prevailing last
year.-N.W. ATTACMIENT F

U.S. SEN&M,
COMM=M ON COMMERCE, SCIENCE, AND TRANsPoRTATiox,
Wa-4ington, D.C. 7 May 4,1978.
DtAR MiL SF:cRwARY: As you are undoubtedly aware, Congress is
currently considering, legislation which would regulate recombinant
DNA research and its applications. The use of recombinant tech-
niques to modify the fundamental genetic material offers great
promise for all of mankind through improved understanding of
biological processes, and varied applications in such fields as medicine,
production of enzymes for industry, and agTiculture.
Nevertheless, as with any new field of scientific research, it is im-
possible at this stage to say with absolute certainty that there is no
hazard attendant to such research. To date, there have been no illnesses
or other harm associated with recombinant DNA research. There have
been recombinant processes occurring in nature since life began, and
nature has built-in defenses against aberrant DNA strains. However,
we cannot ignore the theoretical risks and the necessity to protect the
health and safety of the public and- the environment until further
evidence is accumulated.
The implications for all of science and technology from the regula-
tioh'of scientific research dietate tba.t we move cautiously and fully
explore, all of the alternatives and ramifications before embarking on
a course, of regulation. The Senate Science. Teehnology, and Space
Subcommittee, of which I wn the ranking member, held three, days
of hearings during November, 1977, to consider the major policy issues
associated with recombinant DNA research. The general thrust of
the testimony from the more than 20 witnesses was that if there is
determined to be a need for legislation it should be directed toward
extending the National Institutes of Health (NIII) guidelines to
no-n-Federal fimded research on recombinant DNA. I generally
agree -with that conclusion, although I am concerned that we might
initiate unnecessary and unreasonable restrictions on the conduct of
basic scientific research.
Both the House and the Senate have bills pending which would ex-
tend the NIH guidelines to the private sector and assign responsibility






78


the
US,
Unc


it has
author
promu.
pliancE
scope
where






79,,,,,
Iam uclarastoth secfi rguatryauhoit p te ee
reay ne Scin 6.Plaeprvd 9 oprhn iveaa
ofteSceaysttlatoitine eto 6 orglt
reobiatDN esac adreae atviis icuibu
,notlimted o te folowng iems
a. etenion f te NI gudelies o no-Feeraly fnde
research
b. athoity o lcene families






80

DHEWV. S1713 does not meet these needs as well as H.R. 11192 seems
to do.
2. Do we agree with the conclusion of the Federal Interagency
Committee on Recombinant DNA Research (March, 1977) that no
present authority is sufficient to deal with recombinant DNA tech-
niques in every regard? Yes. As we discussed in detail before your Sub-
committee on November 8, only Section 361 of the Public Health Act
has the potential to meet this bi~oad mandate. However, 361 does not
meet every aspect of the situation, as will be explained in the next
few questions.
3. Could Section. 361 be used to cover the private sector? Yes.
4. What problems might arise from use of Seotion. 361 to relate
recombinant DNA research? One concern often raised is the notion
that invoking Section 361 would seem to some to acknowledge a sig-
nific ant risk of transmission of comm-unicable disease. Present evidence
makes such risks strictly conjectural. Section 361, of course, was not
written to regulate research. Its u~se in this regard may provide prece-
dent for broad intrusions into the research environment, with Con-
gressional debate. Section 361 does not deal with hazards to the en-
vironmeint that can be shown to have no primary or secondary effect
on human health.
5. What are the authorities of the Secretary under Section 361?
For a comprehensive analysis, you should inquire of the General
Counsel at DH.W. Probably you have done so already. Our own
review suggests that Section 361, together with Section 368, provides
broad statutory authority for the development of detailed relations
for essentially all of the functions you name.
6. Compare the authority of the Secretary under Section 361 with
that under the currently proposed legislation. In the absence of de-
tailed analysis from DHEW on Section 361, such a comparison is not
feasible. Certainly, authorities would be far more explicit under the
specific bills than under Section 361.
7. Does the Secretary have authority under Section 361 to preempt
State and local actions concerning recombinant DNA research said
related activities? The Secretary apparently would not have the au-
thority to preclude State or local actions more stringent than the
national standards or regulations.
I hope that these responses are helpful to you in the current delib-
erations.
Yours sincerely,
FRANK PRESS, Director.









iiiiNDIXi
=i~~S ........................................
(I odeio aperace

PiiHadePeietNioa Acdm fSiences
Paul Berg, Wilson Professor of= iociih emiH~ i stry, Deatmn of Bice istryii
IStanb == rd I========= University..... M edica Center.......==i==il
JoahnAa ig soit rfso fMlclrGntc eateto
. N Biloy Mascuet ntttifTcnlg
Roy~~~ ~ ~ ~ ~~~~~...... CktsII eirPoesro"McoilgDprn fMcoiogyiiiii
..................... o f iA...........a
... ............. .... =" ""EiiLiii ...................................................o g U n i v e r
sity of Massachusett
C l f o d G o s e r f s o f B oi ca ........................................................ ....................................t iii
.......................................gio
Danil Cllahn, irecorThe astngs entr Intitte o Soiety Et in
the .Afe Sience
Marsall SapoProesso ofLawUniersiy o Virini
Ala=Lapps, Ciej Offce o HelthLaw nd alue% DeartentifiHelth
Californi
Fran PrssDiretor Ofleeof Siene ad TehnoogyPoley, xectiv Ofi







82

Newman, S tuart A., Professor, Dept
University of New York at Albany, I
Sinsheimer, Robert, Chancellor, Uni'
December 5, 1977
Communications from:
Burris, Robert H., Professor of Ag:
Szybalski, Professor of Oncology,
1977
Cohen, Stanley N., Professor of Medic
Medical Center, October 27, 1977
Hess, Eugene L., Executive Director,
Experimental Biology, November 29,
Hyland, William F., Attorney Genera
1977
Lennette, Edwin H., President, Tissi
1977
Magee, P. T., Chairman, Departmen
Michigan State University, Decembe
Shapiro, James A., Department of
November 10, 1977
Szybalski, Waclaw, Professor of Onc
ary 4,1978
Goldstein, Richard, Department of Mi
of Medicine, to Donald FredrickE
Health, August 30, 1977
Gorbach, Sherwood, Professor of Med
sity School of Medicine, to Donald
Redys, John, Director, Laboratory E
of Connecticut, to Pamela Appe, F
Sullivan, Clare D., graduate student,
Donald Fredrickson, December 29,11


EXECUTIVE
OFFIcE OF S
Hon. ADLAi E. STEVENSON,
U.S. Senate,
Washington, D.C.
DEAR SENATOR STEVENSON: Thank you
for the opportunity to testify before you
recombinant DNA research and application
You have raised searching questions aix
of Section 361 of the Public Health Serv
regulations covering recombinant DNA a(
the Department of EW's Office of Genm
applicability of Section 361, took the posil
the use of Section 361. Most of the anal,
was directed at the Toxic Substances Coi
and Health Act, as reported in the Inter
language of Section 361, dealing with "quc
diseases as smallpox, cholera, yellow fei
many policymakers and scientists. Dr. 0
do indeed reflect a concern that use of Seo
speculative hazards associated with DNA r
Since our November testimony, Dr. Om(
the uses of Section 361. with the assistance(


pet






040
00

VXWUct10n of milk, and standards for water In a way that clearly establishes
dW PWerence for prevention of the occurrence of any risk, rather than control
of the spread of infection. It is our understanding that the NIH Guidelines on
Recombinant DNA Activities are directed at exactly the same objective: to
assure that risks of infection being released be eliminated by stringent control
over practices and facilities.
Thus, we have raised to an interagency group, Including representatives of
the Office of the General Counsel of DHEW, the potential applicability of See-
tiou 361 in the event that the Congress decides that legislation specific to DNA
research cannot be agreed upon and that use of Section 361 Is necessary. This
single authority, with DHEW the clear lead agency, might well be adequate.
We do agree with HEW, of course, that Section 3431 was not written for the
purpose of regulation of research or even of research applications and that
extensive justification and detailed regulations would be required. Such regula-
tions would be required under proposed legislation, as well. We understand
that HEW prefers specific Congressional authorization and that Congressman
Rogers is reviewing the Administration's proposals along with other alternatives.
Now let me turn to the other two issues you raised.
Issue No. 9
The Department of Commerce activities are progressing satisfactorily. Staff
from their Office of General Counsel and from the Office of Environmental Affairs,
under Assistant Secretary Baruch, and staff from my Office have met several
times with representatives of the Pharmaceutical Manufacturers Association and
certain industrial firms. Meetings with labor officials and with representatives
of environmental groups are being scheduled. The activity I mentioned above
about use of Section 361 and the discussion of new legislation in the Congress
has complicated the context of their inquiries, but they are going ahead. Sur-
veillance mechanisms under discussion include registration, biohazards/biosafety
committees with public members, and sanctions for violations of guidelines.
Issue No. 3
The redemptions provided in S. 1217 (now withdrawn by Senator Kennedy)
and in Amendment 754 by Senator Nelson were introduced, I presume, to clarify
responsibility for establishing regulations under any new legislation pertaining
to, DNA activities. Since the Secretary of HEW would be charged with the
implementation of the Act, the Secretary could instruct FDA to require evidence
of compliance with DNA regulations in order to approve new drug applications.
The NIH Guidelines, as revised, will meet the needs of the Department of Agri-
culture, we are advisedL OSHA reserves the possibility of entering into this
matter later, if evidence of significant hazard to employees should arise. NIH
guldelines and any regulations developed under new legislation or under Section
W1 seem adequate for the workplace at present.
Therefore, we see no present need for changes in other statutes. Nor is there
any apparent need to preempt existing statutes.
In closing, let me add that the recombinant DNA work seems to be progressing
weU and safely, with additional information during the past year that has per-
mitted more sober and realistic discussion of the potential risks. These risks
now seem sufficiently low and the NTH Guidelines sufficiently stringent that the
public should be much reassured. Furthermore, I believe that the NIH has very
-effectively engendered public discussion, and I see little Indication for a public
commission to enhance or possibly reignite the debate of the past few years on
this subject.
We are eager to work with you and with other Committees of the Congress In
following the development of this research and its applications.
Yours sincerely,
ft&Nx Puss, Director.
Attachment
ODVMGTON & BVRLIWO,
'Washington, D.C., rowarV 6, 1978.
GrLBmT S.. OxmqN, Ph. D., M.D.,
A884tant Director for Human Respurvet and SocW and Bconoinio Services,
Office of Science and Techtw1ogV PoMV, Washington, D.C.
Dr.&R Gm: As you requested, I have reviewed the background of Section 361
of the Public Health Service Act (42 U.S.C. 264), its Interpretation and applt-
.callon by the Food and Drug Admint tratton and the Public Health Serylee over































pull
of T


ar1
infi




85

.JqOaa testing and certification for interstate shipment of such turtles, In order
to. prevent the spread of salmonella. This regulation was madefinal In the Federal
Itegister of November 18,1972 (37 P.R. 24670).
? On the basis of additional information showing that the certification program
was not effective, FDA issued two additional alternative proposals in the Federal
Register of May 28, 1974 (39 F.R. 18463) that would either prohibit the sale and
other distribution of small pet turtles or would improve the certification scheme
jmd impose additional requirements on the sale and shipment of these turtles.
In disewsing thefirst of his two alternative proposals in the preamble, the Com-
utissioner stated that:
"Under the Public Health Service Act, the Commissioner has the authority to
extend a prohibition on distribution of all turtles and turtle eggs, whether or not
they have passed through interstate commerce, if in his judgment such a com-
plete ban would be necessary for effective control over the interstate spread of
turtle-associated diseases." (39 FJEL at 18464.)
On the basis of the comments received, the Commissioner Issued a final regula-
tion in the Federal Register on May 23, 1975 (40 F.R. 22543), banning all such
turtles from intrastate and interstate commerce. In paragraph 13 of the preamble,
on page 22545, the Commissioner specifically rejected a suggestion that the turtles
should be banned from interstate shipment but should be permitted for Intrastate
shipment.
Subsequently, the State of Mulsiana. brought gait to enjoin enforcement of
this regulation on a variety of legal grounds. In State of Louisiana v. Matthews,
427 F. Supp. 174 (E.D. La. 1977), the Court upheld the legality of the regulation
against all challenges. Specifically, the Court ruled that FDA. could properly ban
all small turtles rather than only those turtles shown to be Infected and thus
to be health hazards, on the ground that "Congress has granted broad, flexible
powers to Federal health authorities who must use their judgment In attempting
to protect the public against the spread of communicable disease." The Court
rejected, as unproven, a contention that less drastic means of regulation would be
nfflcient to protect the public. It ruled that Section 361 permits FDA to control
intrastate as well is interstate activity. Finally, it rejected a contention that the
regulation Is discriminatory because there are no other comparable regulations.
For another court decision broadly upholding the discretion of HEW to enforce
Section 261 see United States v. Shinnick, 219 F. Supp. 789 (E.D. N.Y. 1963).
IV
Section S61 has been applied by the Public Health Service and FDA In the past
In a wide variety of ways. In general, the Public Health Service was responsible
for implementation of Section 361 until the late 1960s when responsibility for
implementation of its foreign aspects were delegated to CDC and for imple-
mentation of Its domestic aspects relating to the law enforcement functions of
FDA were delegated to FDA. (Copies of the current regulations Issued under
Section 361 by the Public Health Service In 42 C.F.R. Parts 71 and 72, and by
FDA In 21 C.F.R. Parts 1240 and 1250, are enclosed. Do not be misled by the
citation, as -legal authority for these regulations, of Section 215 of the Public
Health Service Act; that provision merely authorizes HEW to issue regulations
to implement the Public Health Service Act)
As you will see, these regulations cover a wide variety of subjects. They deal
Ju detail with the sanitation of interstate conveyances. The Drinking Water
Stmdards in 42 C.F.R. 72.201-207 relate not just to bacteriological quality. but
also to pbysical and chemical characteristics which surely would not fall within
any narrow definition of the concept of a "communicable disease." The Drinking
Water Standards have been enforced as the national standard since 1962.
Etiologic agents are defined, and their transportation regulated, under 42
C.F.IEL. 72.25. Psittacine birds, lather brushes, and plain garbage are regulated
under 21 C.F.R, 1240.65, 12AO.70, and 1PA0.75, as a prophylactic measure to pre-
irent disease.
1por many years, the Public Health Service, and more recently FDA, bas
engaged in joint programs with State and local government agencies and with
the regulated Industry to promote sanitation In the produeflon. of milk products
and shellfish, and in the provision of food In eating establishments, under the
general provisions of Section 361. Development of the Pasteurized Milk Ordinance
and Code, through the Interstate Milk Shippers Conference, has had a major
Immet, on milk sAnitation. The PMO provides detailed requirements for the
handUng of milk and dairy products on the farm, In order to prevent the posd-








bflity of communicable disease. The goigcniin o hlfs aes
Ilarly been the subject ofcotosic194udrheNinaSelfh
Sanitation Programn, and FDA has proposed toesalhrgutincofyg
this program in the Federal Register of June 19, 97 (4 P.R.251)whcar
now being held in abeyance pending further study rqie yCnrs nSc
tion 16(b) of P.L. 94-370 (90 Btat. 1013, 1033). FDA proif it s
40-year history of cooperation on food sanitationprgasfrodsevc
establishets in the Federal Register of October 1, 1974 (3 F.R.358)an
has since conlued instead to issue a model ordinance as anucdi h
Federal Register of March 22, 1977 (42 F.R. 15428). TUnder the>sm utoiy
FDA has announced a proposed Model Retail Food Store Sntto riac
in the Federal Register of October 25, 1977 (42 F.R. 56367) and a oe edn
of Food and Bev~erages Ordinance in the Federal Register ofOcoe7,17
(42 F.R. 54626).*
Finally, in a variety of regulations in the past few years deindt4mlmn
a national blood policy, FDA has utiltzed Section 361 to control blood hankn n
blood labeling practices in intrastate as well as interstate comrn e hepe
ambles to these regulations seiial eto h edfrcoecnrlo l
blood practices, in minute detail, in order to preventcomnabedss.
Copies of the proposed regulations to establish current goodmauctrn
practice for blood and blood components published in the FederalReitro
May 28, 1974 (39) F.R. 18614) and to require a label staeett itnus
volunteer f rom paid blood donors published in the Fera eiseofNvm
ber 14, 1975 (40) P.R. 53040), both of which discuss this subject, adboho
which provide extraordinary detaild requirements, are enclosed.

V
Questions have been raised about the dereand natrofhepenilam
that must be shown in order to invoke the authority o eto 6.I per
that the language ofthe statute itself, its leiltive hsoy n h or
opinion interpreting place broad discretion in HEW to
scientific evidence warrants reliance on Section 301 to preventthposbly
of communicable disease. Absent evidence that the HEW decioiswly
irrational, it is highly likely that the courts would
discretion.
Nor is there any limitationin Section 361 on the source from whih
tial harm must come in order to justify regulation. The terms o eto 6
permit regulation of research or of commercial activity. Indete rsn
regulations governing transportation of etiologic agents directly afetbai
research, sand a number of regulations affect commercial activity. Th a emt
control of human beings, animals, plant material, and any other formofatce
in irder to prevent communicable disease,
With specific reference to research on recombinant DNA molecesthqu-
tion has been raised whether there is sufficenet danger of commuial ies
to justify invocation of Section 361. If indeed there is no signficanposblt
of this occurring,~ it'is difficult to understand why the United Sae oges
NTH, the entire scientific community, num~erous stte -isaue an iylon
cls, and many citizens groups, have been spedn suc aninrnaemot
of time debating it. The very nature of the cotvesislfssuicnInm
j1udgment, to establish the potential for harmthtireuednerScon3.
Ifthat potential were ag ovrthi research would nee hae been raisdi h frtpae
More apecifically, some hav questioned wvhete otosoe eti ye
of research on. recombinantDN moeuescasrsrhonpntaeil,
can be justified under Secton 36, ices argaln heneo cotlarssfm
Potential communication of disease frm one plant to aohrrte hnt
man. Others have argued, however, that so little is recombinant DNA molecule that~ there is indeed adagrwhcwilemn
untl frthr epermenaton. proes otherwise, tht rearhoplnmtris
cld unles pathogenic oraim to Infetmn orcolotewsrsuti
cotroversy, which as
th NationlEromental Polc Ac




1 ......................................... ............. .....i ........ ........ .. .......i i..
e v on en t a l a s p e c ts o f t h e m a tte r E n v ir o n m e n ta l D f e n M F u n d I n c v .
Afatthewa, 410 P. Supp. 336. (D.D.C. 1976).i~i



I t Is im p o r ta n t, o n c e a g a in to u n d e r s ta n d th a t S e c tio n 3 6 1 w a s in te n d e d b y
Con res br a l to......... iiiii[""ii" authoriiiiiiiiiiiiiiiiiiiii~ H~ii~iiiii~iiii~ii~iii~i~iii~i public health measures to preventii~iiiiiii~i~iiii
disease before it occurs. All that is needed to support regulations under thisiiiiiiiiiiiiiiiii~iiiiiiii
provision~ iiiiiiiiiiii eihe apreenioioiucetant aou teos ibii of potential
harm,...........c..........qua.....n..o..ma......showing... that..the i harm .......oti ociiuiiiand
.............................................. ................................ dioc c u r .
Th mresriuste atr o tepoenil arth ls i rqiriniiii theiiiii
way f aprehnsin ofuncrtaity bouttha har inordetojus ifyinvokiiiI

regulatoryiiiiconiioilsiinderiiiectioniii361.





V11
Questons ave lso rise abot enorceent f an reglatins isuedunde
Socton.361.Secion361 tsef prvids tat ay aticls nt i comliace i
such egulaions ay bedestryed, nd auhorizsianyotherenforementmeas







ure tatma b coclde t b neesar. n nitaly roulatig tstutl

reglatons FD Inludd areqireentforbacerilogcaltesingandcer ifi-ii








00
00





HH O %
i ~ i l = 0 V

m u c h b r o a d e r a n d u n d e sire d -4 m p a c to u p o n th e o v e r a ll r e g u la to ry p r o g ram
fo oxcsbsacs.Rter eleethtItwud emreapopit t n
set, omprhensve lgisltionreguatin allaspets o recmbinntiDA ire
searh-inludig al comercil apliction--whch wuld e sesitieitothe
unique roblem and Isues atendantto thi fronterioficience
In ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~~~.. clsnhwvr ol iet mhsz hti h bec flgsa ii~iii
whchsecfcal adese teunqe rolmsasoite it ecminn

....................................................................o........e@ i p u b l i c
to ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~~~..... thiiiiietn ncsayagis nyuraonbers oinuyiohat
............ th niomn hc a epeetdb n eobnn N c ivi
utiliing SCA nd oher xistng athorties
Sincerelyiiyours,
DOUL&BM.COSI |


Adinstatr









lion.~~~ ADiiiv~sN
Ohafman Sucomitte o Scenc, Tchnlog, ad Sace Comitee ni
Oomere, cince ad Tanporaton U.. enae,'Wahigto, .C

DEA R. CAIRAN: his illrespnd o yor leterof Nvembr.3,..9..t






90

DEAiTMENT OF AGRICULTURE,
OFITCE OF THE SERETARY,
*Washington, D.C., December 3, 1977.
Hon. ADLAI E. STEVENSON,
Chairman, Subcommittee on Science, Techanologyl~, and Space,
U.S. Senate, Washington, D.C.
DEAR MR. CHAIRmAN: This is in reply to your inquiry dated November 30,
1977, regarding authorities to regulate products of DNA research and microbes
or other organisms containing recombined DNA. Specifically, you requested to
be advised whether the Animal and Plant Health Inspection Service (APIS)
of this Department has the authority to control microbes or other organisms
containing recombined DNA in animals and plants, and whether authority exists
to directly control organisms containing recombined DNA.
Since this is a relatively new area of scientific endeavor, and since the end
results of DNA research are still mostly conjectural, we cannot specifically
point to any statute administered by APHIS which would be definitely ap-
plicable to such research. However, there are several statutes which are ad-
ministered by APRHIS Wch may ultimately be affected by either the end
products resulting from DNA research or by organisms containing recoined
DNA.
The major programs that are administered by APHIS uder which certain
products of DNA research or orgasms containing recombined DNA could be
regulated are as follows:
A. The Animal Quarantine laws, especially 21 U.S.C. 111, 114, 114 (b), 123 and
134 (a)
The main purpose of these laws is to prevent the introduction into' the United
States, or the dissemination from one State or Territory or the District of Co-
lumbia to another of the contagion of any contagious, infectious, or communi-
cable disease of animals and/or live poultry. Under these laws, the Secretary
of Agriculture has the authority to promulgate such regulations hind to take
such measures as he may deem proper to prevent such Introduction or dissemi-
nation. Any product of DNA research or any organisms containing recombined
DNA which could be classified as such a "contagion" would be subject to the
Animal Quarantine laws.
Section 122.2 of Title 9, Code of Federal Regulations, applies specifically to
organisms and vectors. It states that no organisms Or vectors shall be imported
Into the United States or transported from one State or Territory or the District
of Columbia, to another State or Territory or District of Columbia without a
permit. Organisms are defined in section 122.1(e) of Title 9, Code of Federal
Regulations as "All cultures or collections of organisms or their derivatives,
which may Introduce or disseminate any contagious or infectious disease of
animals (including poultry) ."
B. The provisions of the Vir s-Serum- Toxin Act (21 U.S.C. 151, et seq.)
The purposes of this Act, as stated in the Legislative History (See, e.g., Senate
Committee Report No. 1288 on H.R. 28283, 62nd Congress) is to prevent "the
introduction into the United States of dangerous and worthless viruses, serums,
and analogous products for use in the treatment of domestic animals.. and4
also for the purposes of controlling the use, by preventing the interstate ship-~
ment, of similar dangerous, and worthless products that may be manufactured
within the United States".
Therefore, products of recombinant DNA research which could be considered
viruses, serums, toxins or analogous products (i.e., veterinary biologics), a
well as any recombined DNA containing organisms used to produce them, which
are subject to the provisions of the Virus- Serum-Toxin Act, would also be subjet
to APHIS regulation.
0. The Federal Plant Pest Act, particularly 7 U.S.C. 150bb and 15044
'This law is mainly concerned with the prevention of the dissemination of plant
pests in the United States. The Secretary of Agriculture has the authority to pre
vent the introduction of such pests which are moved from a foreign country into
the United States, or interstate. Therefore, any products of DNA research Or or-
ganisms containing recombined DNA which'fall under the category of plant pest
would be subject to regulations by APHIS.
There are, of course, other authorities which might have an Impact In this
area, such as the Federal Meat and Poultry Inspection Acts (21 U.S.C. 601, et