33046 
NOTICES 
describes how the PRG-RAC differs 
from the 1976 guidelines: the second 
describes (1) the public comments re- 
cel, ed both before end after the De- 
cember 1977 DAC meeting, concerning 
the PRG-RAC. and <2) the changes 
whxh have been made in response to 
these comments leading to the PP.G- 
N1B. 
Fo c r-SOT ES TO I»T»OOCCTTOS »9 OVWTTT* 
<f) In addition to the proposed revtoed 
guidelines and this "Decision Document.” 
there is also be ns released an Environmen- 
tal 'most Asoesemnvni. including numer- 
ous appendices. 
<J> The capability to perform DMA reeum- 
bi ukttors. and the potential huards, had 
become apparent to scientists at ihe Gordon 
Research Conference on Nuclev A. ids In 
July 1973. At their behest Use National 
Academy of Sciences created a committee 
that ortanlaed an irtemational conference 
held In February 1*75 at Aailo-nwr Confer- 
ence Center. Pacific Grover Call. Atprjii- 
raatel- 150 scientists, of w*-om a th-rd were 
from foielgn countries, were pres-ut. The 
ecminUee aiso called on the National Ins' I 
lutes of Health to establish an advisory 
committee to draft guidelines for the con- 
duct of this research Temporary glide tinea 
were issued a. Aslidmor pending jUuar.ct of 
NIH guidelines. 
In response, the KIH Recombinant Advi- 
sory Coran- h tee < formally NIK Rtccmbin- 
ant DNA Molecule Program Advisory Com- 
ml'tee") was rstabHihed In Ortoto* r 1*74 to 
advise the Secre-ary of HFW. the Assistant 
Secretary for Health, an 4 the Direct or of 
NIH to accor.ir.eh these tasks The several 
meetings at which the Recombinant Adviso- 
ry Committee developed Its proposed guide- 
lines in 1975 were announced in the Flsuu 
Ro tv.nt ana were open to U.e public- The 
comm.’ lee. after preparing several draft 
irrslons of gutdrilnea reached agreement 
on a recommended revised re-sion. which 
was referred to the NTH Director for review 
In Decetrber 1*75 
A special meeting of the public advisory 
Committee to the Director. NIH. was con- 
vened in February 1*76 to review these pro- 
posed guidelines, in addition to current 
members of the committee, a number of 
former committee members as well as other 
scicn.'fle and public reur-ven tat ires had 
been Invited to participate There was ample 
opportunity for comment and an airing of 
the issues. oo*h by the committee members 
and the pubi c witnesses All major points of 
view were broadly represented. 
The proposed guidelines were reviewed by 
the Director. NIK. In the light of comments 
and suggestions made at the public hearing 
as well as extensive written eyn-escoodenee 
received after the meeting When the final 
gukte' nes were released in June 1976. an ac- 
companying decision paper desci.bed in 
great detail all relevant public comments 
and the reason for accepting or rejecting 
specific recorrur * r-laUons lr. preparing the 
final guideline*. The NTH guidelines and the 
Decision of the Director. NTH. were pub- 
lished in the rno.ii Rtcirrr* on July 7. 
1976 Ir addition. eopt-» of the guidelines 
we*-* w delv dlv'rtbuted to foreign embas- 
sies. medical and adentilic journals. KIH 
graniees and contractors. and professional 
research societies. 
(J) The foUowirg committees have held 
hearings and/or markup srastons oa Recom- 
binant DNA legists. lor 
House - The Subcomm ’iiee on Health and 
the Environment and its parent, the Com- 
mittee on Interstate and Foreign Com- 
irve*"e the Subcommittee on Svdcncc. Re- 
search. and Technology and iu parent, the 
Comrullee on Science ana Technology. 
Senate— The Subcommittee on Health 
and Scientific Rtvvrdi aid its parent the 
Committee on Human Revcurcea; the Sub- 
committee on Science. Technology, and 
Space Iu parent the Committee on Com- 
merce. Science, and Transportation, has not 
held any hearings or markup sessions on 
this topic. 
BUT 
Chief sponsor 
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The following bills on recombinant 
DNA technology have been formally 
introduced: 
<(' The Recombinant Advisory Committee 
considered its proposed revisions at meet- 
ings throughout 1977. The version proposed 
to the Director. NIH. ir, September 1977. ap- 
peared in the Fionm. Reoistts on Septem- 
ber 27. 1977. 
(Si This mee’ing of the Director's Adviso- 
ry Committee took place In Bethesda on De- 
cember 15-16. 1977 A summary of the meet- 
ing appeared in the recombinant DNA tech- 
nical bulletin, and the complete record will 
shortly be published by KIH In voL 3 of the 
series recombinant DN A research. 
<6> The KIH -sponsored meeting at Fal- 
mouth. Mass., on June 20-22. 1977. was 
charred by Dr Sherwood Go roach A com- 
plete record of this meeting appears in the 
Journal of Infectious Diseases" (May 
1978). 
(7) The C5. EMBO Workshop to Assess 
Risks for Recombinant DNA Experiments 
Involving the Genomes of Animal. Plant, 
and Insect Viruses” was he’d on January 26- 
28. 1978. in Ascot. England. It was attended 
by experts on viruses from the United 
States. Britain, and other European coun- 
tries. a majority of whom were not engaged 
in recombinant DNA research. The primary 
purpose cf the meeting was to conduct a sci- 
entific and technical analysis of possible 
risks associated with cioning eukaryotic 
viral DNA segments in E. coil K-12 host- 
vector systems and with the use of eukaryo- 
tic viruses as cloning vectors in animal, 
plant, and Insect systems. The report of the 
workshop was published to the Federai. 
Rtcirre* on March 31. 1978. and appears as 
appendix E to the accompanying environ- 
mental Impact assessment. The results of 
the Ascot meeting were then reviewed by 
another group of U-S. virologists who con- 
verted them into recommendation: for revi- 
sion of the guidelines. This working group 
was chaired by Dr. Harold Ginsberg and 
met on April 8-7. 1978 Its report appears as 
appendix P to the accompanying environ- 
mental impact a^essmenh The report was 
considered by the Recombinant Advisory 
Committee at its April 27-28. 1978 meeting. 
(I) The “Workshop on Risk Assessment of 
Agricultural Patnogens was held on March 
20 21. 1978. in Washington. D C. under the 
auspices of the National Science Founda- 
tion. the Department of Agriculture, and 
the National Institutes of Health. A copy of 
the report of this workshop appears as ap- 
pendix G to the accompanying environmen- 
tal impact assessner.t. 
<»> The United Kingdom guidel’nes. aiso 
known as the Williams report." were Issued 
in August 1976. A fairly comprehensive 
review of the international aspects of re- 
combinant DNA research, including issu- 
ance of national guidelines, is contained In 
the "Report of the Federal Interagency 
Committee on Recombinant DNA Research: 
International Activities.” November 1977. 
This Is available from the Office of Recom- 
binant DNA Activities. National Institutes 
of Health. Bethesda. Md 20014. 
<J9) Under the NTH guidelines, experi- 
ments using prokaryotic hosts other than E. 
coii K-12 are severely limited whereas such 
experiments are proceeding in Europe, espe- 
cially with Bacillus ru&fiiu. Certain other 
categories of experiments require according 
to the NIH guidelines, either P4 - EK2 or 
P3 - EKJ containment. Since no EX 3 system 
FtOHAl lEGISTTt VOi- 43. NO. 148— fltWAY. JUIY 28. 1978 
17 ] 
