Federal Refuter / Vol. 4d. No. 54 / Friday, March 20. 1961 / Notices 
17M6 
or by any institutional ofTicial be 
required. 
Suboption B-l-c: Under Suboption B- 
1- c, experiments involving Class 3 
agents would require Pi containment 
conditions. No registration document or 
review by the IBC or a designated 
official, however, would be required. 
The status of these experiments would 
then be equivalent to experiments with 
CDC Class 1 or Class 3 agents. 
Suboption B-2-a: Under Suboption B- 
2- a. deliberate attempts to obtain 
expression of a eukaryotic gene in E. 
coil K-12 would continue to require 
pnor review by the IBC. 
Suboption ^2-b: Under Suboption B- 
2-b. no prior review of ex^nments 
involving deliberate attempts to obtain 
expression of eukaryote gene in E. coli 
K-12 would be required. 
Option C — Exemption of Experiments 
Currently Covered by Section iU-O: 
Under Option C. expenments currently 
covered by Section III-O would be 
removed from Section III-O. These 
experiments would be exempted from 
the Guidelines under Section l-E-5. The 
exemption would apply to all 
nonprohibiled experiments which use 
either laboratory strains of 
Sacchoromyces cerevisiae or E. coJi K- 
12 as the host-vector system. 
Suboption C-l-a: Under Suboption C- 
1-a. the exemption would apply to all 
nonprohibiled experiments using E. coli 
K-12 as the host 
Suboption C-l-b: Under Suboption C- 
1- b. the exemption would be qualified 
with the statement that "(a) the E coh 
host shall not contain conjugation 
proficient plasmids or generalized 
transducing phages, and (b) lambda or 
lambdoid or Ff bacteriophages or non- 
coniugative plasmids (49) shall be used 
as vectors ” This qualification would 
then be qualified by the statement that 
experiments involving the insertion 
into £. coh K-12 of DNA from 
prokaryotes that exchange genetic 
information (35) with E. coh may be 
performed with any E. coh K-12 vector 
(e g . conjugative plasmid). When a non- 
conjugative vector is used, the E. coh K- 
12 host may contain conjugation- 
proficient plasmids either autonomous 
or integrated, or generalized transducing 
phages ' 
Suboption C~2~a: Under Suboption C- 
2- a. language would be added to the 
Guidelines to explicitly make 
Prohibition l-D-6 concerning large-scale 
applicable to these experiments 
Suboption C-2-b: Under Suboption C- 
2-b. Prohibition l-D-6 would not apply 
to those experiments That is. 
experiments involving over, as well as 
under. 10 liters in volume would be 
exempt from the Guidelines. 
Suboption C-3-a: Under Suboption C- 
J-a. the entry in Appendix C which 
would effect the exemption under 
Section l-E-5 would contain a statement 
that although exempt, for these 
experiments "PI physical containment 
conditions are recommended." 
Suboption C-3-b: Under Suboption C- 
3- b. no statement would be included 
recommending PI physical containment 
conditions. 
Suboption C-4-o: Under Suboption C- 
4- a. experiments involving the cloning 
in E. Coh K-12 of DNA from CDC Class 
3 etiological agents would not be 
exempted. Rather they would continue 
to require P3 containment conditons and 
would continue to require review and 
approval by the IBC. 
Suboption C-4-b: Under Suboption C- 
4-b. expenments involving the DNA of 
CDC Class 3 agents would not be 
exempted. However, containment might 
be specified at PI. P2 or P3. and some 
form of review by either the IBC or an 
institutional official would be required. 
Suboption C-4-c: Under Suboption C- 
4- c. experiments involving the cloning of 
CDC Class 3 agents in E. Coh K-12 
would be exempt 
Suboption C-S-o: Under Suboption C- 
5- a. attempts at deliberate expression of 
a eukaryotic gene in E. coh K-12 would 
continue to require prior review by the 
IBC. 
Suboption CS-b: Under Suboption C- 
5-b. no prior review of experiments 
involving attempts at deliberate 
expression of a eukaryotic gene in E. 
coh K-12 would be required. 
II. Proposal To Convert the NIH 
Guidelines Into a Code of Standard 
Practice and To Reduce the 
Recommended Containment Levels for 
Some Experiments 
Drs. Allan Campbell and David 
Baltimore. RAC members, propose to 
convert the NIH Guidelines into a "code 
of standard practice" and to reduce 
recommended containment levels for 
some expenments. They propose that 
the Guidelines be amended as follows: 
(1) Section l-A of the Guidelines 
would be amended to read as follows; 
l-A. Purpose The purpose of these 
Guidelines is to specify standard practices 
for constructing and handling (i) recombinant 
DNA molecules and (ii| organisms and 
viruses containing recombinant ONA 
molecules. Adherence to these standards by 
all laboralones using recombinant DNA is 
recommended. 
(2) Section l-C of the Guidelies wold 
be eliminated. 
(3) Part III of the Guidelines would be 
replaced with the following: 
Part III discusses experiments covered by 
the Guidelines The reader must first consult 
Part I. where lislinga are given of prohibited 
and exempt experiments. 
Where there are existing recommended 
physical containment levels applicable to 
non-recombinant DNA experiments with 
either the host or the vector (such as those 
specified by the CDC Guidelines), 
recombinant DNA experiments should be 
carried out at containment levels at least as 
high as those recommended for non- 
recombinant DNA experiments. Otherwise, 
all non-prohibited experiments may be 
carried out under conditions of PI physical 
containment. As a general practice, 
investigators should use the highest level of 
biological containment (HV3_HV2 HVl) 
which is available and appropriate for the 
purposes of the experiment. 
Specific exceptions to the prohibitions may 
be approved by the Director, NIH (see 
Section l-D). The Director will consider 
requests for exceptions from individuals, 
institutions or corporations regardless of 
whether the applicant is affiliated with or 
supported by NIH. Such exceptions will 
generally be approved for specified levels of 
physical and biological containment. 
This will be followed by a listing of 
those exceptions which are presently 
authorized and the containment levels 
approved for the excepted experiments. 
(4) Part IV of the Guidelines would be 
eliminated, with the following 
exceptions: 
(a) Those definitions listed in Part IV- 
C which may be needed to clarify 
statements made elsewhere in the 
Guidelines shall be retained. 
(b) Those portions of Part IV-E 
defining the composition of RAC and 
prescribing rules for RAC procedures 
shall be retained. 
(c) The following statement shall be 
added: 
Each inilitution conducting or sponsoring 
recombinant DNA research should take 
responsibility for monitoring its own 
activities in this area. Any unusual events 
that might be associated with the use of 
recombinant DNA molecules should be 
reported to the Director. NIH. 
(5) Section VI of the Guidelines will 
be eliminated, except for those portions 
of section VI-F relevant to the 
protection of proprietary information 
submitted in support of requests for 
exceptions from the prohibiitons. 
The authors provide an explanaton 
and justification for their proposals in a 
letter to ORDA. 
III. Containment Levels for Recombinant 
DNA Experiments Involving Neurospora 
Crassa 
Dr. David Perkins of Stanford 
University has proposed that entry 2 in 
Appendix E be amended to read as 
follows: 
Unmodified laboratory strains of 
Neurospora crassa can be used in all 
( 75 ) 
