59398 
Federal Register / Vol. 46. No. 233 / Friday, December 4, 1981 / Notices 
there could be a recommendation that 
these experiments be reviewed by the 
RAC. 
Mr. Daloz moved that a vote be taken 
on Dr. Baltimore's motion, as amended. 
The motion to end discussion and vote 
failed to carry by a vote of four in favor, 
fourteen opposed, with three 
abstentions. 
Dr. Ahmed said he wanted detailed 
procedures built into the revised 
Guidelines for handling the currently 
prohibited experiments. Dr. Baltimore 
said that the absence of detailed 
procedures pertains in the case of all 
nonrecombinant DNA laboratory work 
including that with known pathogens. 
Mr. Thornton asked for a show of 
hands of RAC members who wished to 
continue discussion of this agenda item 
for an additional thirty minutes until 
approximately 3:30 p.m. The vote was 
eighteen in favor, one opposed. 
Dr. Mason said that the RAC and the 
Guidelines cannot deal with scientists or 
industrial groups who are uninformed, 
dishonest, or careless. We have tried to 
produce guidelines that reponsible 
people will follow. There is no way to 
provide for every contingency. 
Dr. Holmes moved to add current 
prohibition l-D-4 (“deliberate release 
into the environment of any organism 
containing recombinant DNA.") to the 
admonitions regarding cloning of toxins 
and transfer of drug resistance traits. Dr. 
Landy supported inclusion of l-D-4; Dr. 
Bems did not support it. The motion 
failed to carry by a vote of eight in 
favor, ten opposed, with two absentions. 
Dr. Baltimore's amended motion was 
reviewed. Dr. Talbot said that if the 
proposal passed, the NIH staff would 
prepare a version of proposed revised 
Guidehnes based on the proposal, and 
that it would be put in the Federal 
Register for public comment, along with 
background describing the work of the 
working group and the deliberations of 
the RAC. NIH would actively solicit 
comment on the proposal beyond its 
publication in the Federal Register. 
I The question was called and the vote 
to substitute Dr. Baltimore's motion, as 
amended, for Dr. Harris' motion was 
fifteen in favor, three opposed, with two 
abstentions. Dr. Ahmed asked to be 
recorded as voting against the motion. 
The motion was as follows: 
i “t. Section I-A of the Caidelines would be 
emended to read as follows; 
“1-A. Purpose. The porpose of these 
Cuidetines is to specify standard practices 
> for constructing aixi handling (i) recombinant 
DNA molecules and (ii) organisms and 
Viruses containing recombinant DNA 
I molecules. Adherence to these standards by 
tail laboratories using recombinant DNA is 
t recommended. 
"2. Section I-C of the Guidelines would be 
eliminated. 
"3. Section I-D of the Guidelines. 
Prohibitions, would be eliminated. 
“4. Part ni of the Guidelines would be 
replaced with the following language: 
"Part III discusses experiments covered by 
the Guidelines. The reader should First 
consult Part 1. where exempt experiments are 
listed. 
“Where recommended physical 
containment levels applicable to non- 
recombinant DNA experiments exist for 
either the host or the vector*, recombinant 
DNA experiments should be carried out at 
containment levels at least as high as those 
recommended for non-recombinant DNA 
experiments. If there is clear evidence that 
the donor DNA will significantly change the 
pathogenicity of the host, the containment 
level appropriate to the anticipated change 
will be applied. Otherwise, all experiments 
may be carried out under conditions of PI or 
PI-LS physical containment. 
"5. Material would be added to Part 111. as 
follows: 
"No experiments should be performed 
which involve: 
"(a) Deliberate transfer of a drug resistance 
trait to micro-organisms that are not known 
to acquire it naturally, if such acquisition 
could compromise the use of a drug to control 
disease agents in human or veterinary 
medicine or agriculture. 
"(b) Deliberate formation of recombinant 
DNAs containing genes for the biosynthesis 
of toxins lethal for vertebrates at an LDr« of 
less than 100 nanograms per kilogram body 
weight (e.g., the botulinum toxins, tetanus 
toxin, diphtheria toxin. Shigella dysenleriae 
neurotoxin). Guidelines for the cloning of 
DNAs containing genes coding for the 
biosynthesis of toxins which are lethal to 
vertebrates at 100 nanograms to 100 
niicrograms per kilogram body weight are 
spedFied in Appendix G. 
"6. Part rV 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 dePining 
the composition of RAC and prescribing rules 
for RAC procedures shall be retained. 
"(c) The following statement shall be 
added: 
"Each institution 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. 
"7. Section VI of the Guidelines will be 
eliminated, except for those portions of 
Section Vl-F relevant to the protection of 
proprietary information." 
The vote on this substitute motion 
was called, and the vote was sixteen in 
favor, three opposed, with one 
abstention. 
* Such MS those specified by the CUC Cuirlrtinns 
or the WSOA QuHrnntme Rryiilutinns 
Dr. Zinder requested that a motion be 
introduced in support of the Adelberg- 
Zinder proposal to eliminate the 
Guidelines and the RAC. No motion was 
introduced. 
Annex E 
Current Guidelines for Research 
Involving Recombinant DNA Molecules 
October 1981. 
These Guidelines are the Guidelines 
as published in the Federal Register of 
July 1. 1981 (46 FR 34462). with the 
incorporation of those changes 
promulgated in the Federal Register of 
October 30. 1981, Part V. 
Table of Contents 
I. Scope of the Guidelines 
I-A Purpose 
1-B Derinition of Recombinant UN.\ 
Molecules 
1-C General Applicability (see IV-B) 
I-D Prohibitions 
1-E Exemptions 
I- F General Deriiiiliuns (see IV-C) 
II. Containment 
II- A Standard Practices and Training 
II-B Physical Containment Levels 
II-B-1 Pi Level 
II-B-l-o Laboratory Practices 
II-B-l-b Containment Equipment 
11-B-l-c Special I.al)oratorv Design 
U-B-2 P2 Level 
II-B-2-a Laboratory Practices 
ll-B-2-b Containment Equipment 
II-B-2-C Special l-aboratory Design 
Il-B-3 P3 Level 
Il-B-3-a Laboratory Practices 
II-B-3-b Containment Equipment 
II-B-3-C Special l.aboratory Design 
lI-B-4 P4 Level 
ll-B-4-a Laboratory Practices 
Il-B— 4-b Containment Equipment 
Il-B--t-c Special Ijiboratory Design 
II-C Shipment 
II-D Bioltrgicul Containment 
II-D-1 Levels of Biological Containment 
II-D-1-h ff\'l 
ll-D-l-b HV2 
ll-D-l-c I1V3 
Il-D-2 Certification of Most-Vector 
Systems 
II-D-2-d Responsibility 
II-D-2-b Data To Be Submitted for 
Certification 
II- D-3 Distribution of Certified Host- 
Vectors 
III. Containment Guidelines for Covered 
Experiments 
III- O Classihcalion of Experiments Using 
Certain Host-Vector Systems 
III-O-l Experiments Involving Class 3 
Organisms 
111-0-2 Experiments Involving 
Nonpathogenic Prokaryotic and Lower 
Eukaryotic Host-Vector Systems 
lll-A Classification of Experiments Using 
Certain HVl and HV2 Host-Vector 
Systems 
IlI-A-1 Shotgun Experiments 
lIl-A-l-u Eukaryotic DNA Recombinants 
[ 287 ] 
1 
