Federal Register / Vol. 48, No. 106 / Wednesday, June 1, 1983 / Notices 
24551 
to the RAC Working Group on Revision 
of the Guidelines without comment. 
The Working Group on Revision of the 
Guidelines at its January 21. 15)83, 
meeting recommended incorporation 
into the Guidelines of the physical 
Containment Recommendations for 
Large-Scale Uses of Organisms 
Containing Recombinant UNA 
Molecules. They pointed out that if the 
RAC recommends this action, editorial 
modifications to revise and update 
sections of the Physical Containment 
Recommendations will be necessary. 
The proposed incorporation of the 
Physical Containment 
Recommendations into the Guidelines 
as a new Appendix K would require all 
sections to be renumbered. 
Minor editorial changes would be 
introduced throughout the document to 
reflect the modifications introduced into 
the Guidelines since the 
Recommendations were published in 
April 1900. Proposed changes within the 
text are enumerated below. The sections 
in the Recommendations which contain 
proposed revisions are identified by 
their current sections numbering. The 
proposed modified language is identified 
by new section numbering. 
1. Section VII. Physical Containment 
for Large-Scale Uses of Organisms 
Containing Recombinant DNA 
Molecules. 
a. Section VII would become 
Appendix K. 
b. The language of the first paragraph 
would be modified. It currently reads: 
This part of the Nil I Guidelines specifies 
physical containment guidelines for large- 
scale (greater than 10 liters of culture) 
research or production involving viable 
organisms containing recombinant DNA 
molecules. It shall apply to all large-scale 
research or production activities approved by 
the Director, NIU. in accordance with 
Sections IV-E-2-b-(l)-(e) and I V-E-l-b-(3)- 
(d) of the NIH Guidelines. 
That paragraph would be modified to 
read as follows: 
This part of the NIH Guidelines specifies 
physical containment guidelines for large- 
scale (greater than 10 liters of culture) 
research or production involving viable 
organisms containng recombinant DNA 
molecules. It shall apply to large-scale 
research or production activities as specified 
in Section III— B— 5 of the Guidelines. 
c. The third paragraph (first bullet) 
will be modified to read: 
Appendix K shall replace Appendix C 
when quantities in excess of 10 liters of 
culture are involved in research or 
production. 
d. An editorial modification, 
substituting "Section 1B-D— 4” for 
“Section IV-D^4.” will be introduced 
into the third paragraph of the 
introduction. That paragraph will be 
modified to read: 
The institution shall appoint a biological 
safety officer if it engages in large-scale 
research or production activities involving 
viable organisms containing recombinant 
DNA molecules. The duties of the biological 
safety officer shall include those specified in 
Section IV-B-4 of the Guidelines. 
2. Section VJ/-A. Selection of Physical 
Containment Levels. This section will be 
renumbered as Appendix K-I. 
3. Section Vll-D. Pl-LS Level. 
a. Section VII— B will be renumbered 
as Appendix K— II. 
b. Section VII-D-1 will be renumbered 
to Appendix K-II-A and an editorial 
modification will substitute "Appendix 
G-II-A” for "Section II-B-1.” The last 
sentence of Section VII— 13— 1 will read: 
Volumes less than 10 liters may be handled 
outside of a closed system or other primary 
containment equipment provided all physical 
containment requirements specified in 
Appendix G-II-A of the Guidelines are met. 
c. Section VII-B-2 will be renumbered 
Appendix K-II-B and an editorial 
modification will substitute "Appendix 
K-II-C” for the current "Section VII-B- 
3.” The first sentence of Section VII-B-2 
would read: 
Appendix K-II-D. Culture fluids (except as 
allowed in Appendix K-II-C) shall not be 
removed from a closed system or other 
primary containment equipment unless the 
viable organisms containing recombinant 
DNA molecules have been inactivated by a 
validated inactivation procedure. 
d. In Section VII-B-6, an editorial 
modification will change the language to 
read: 
Appendix K-Il-F. Emergency plans 
required by Section lV-B-3-f shall include 
methods and procedures for handling large 
losses of culture on an emergency basis. 
4. Section VII-C. P2-LS Level 
a. Section VII-C will be renumbered 
to Appendix K— III. 
b. Section VII-C-1 will be renumbered 
Appendix K-III-A and in the last 
sentence of Section VII-C-1, an editorial 
modification will substitute “Appendix 
G-II-B" for the current "Section II-B-2." 
c. Section VII-B-2 will be renumbered 
to Appendix K-III-B and an editorial 
modification will substitute "Appendix 
K-III-C" for the current "Section VII'C- 
3." 
d. In Section VII-C-11, to be 
renumbered Appendix K-III-K, an 
editorial modification will substitute 
"Section IV-B-3-f' for the current 
"Section IV-D-3-d.” 
5. Section Vll-D. P3-LS Level 
a. Section VII-D will be renumbered 
to Appendix K-IV. 
b. Section VII-D-1 will be renumbered 
to Appendix K-IV-A and an editorial 
modification will substitute "Appendix 
Ci — II— C" for the current "Section II— 13— 3." 
c. Section VII-D-2 will be renumbered 
to Appendix K-IV-B and an editorial 
modification will substitute "Appendix 
K-IV-C" for the current "Section IV-U- 
3." 
d. In Section VII-D-12, to be 
renumbered Appendix K-IV-L. an 
editorial modification will substitute 
"Section IV-B-3-f' for the current 
"Section IV-D-3-d." 
e. In Section VII-D-14-a, to be 
renumbered Appendix K-IV-N-1, an 
editorial modification will substitute 
"Appendix K-IV-M-1" for "Section VII— 
D-13-a." 
Note. — In addition, the language of 
Section I1I-B-5 of the Guidelines would 
also be modified to read as follows: 
1 1 1— B — 5. Experiments Involving More Thun 
10 Liters of Culture. Thu appropriate 
containment will be decided by the 1BC. 
Where appropriate. Appendix K. Physical 
Containment for Large-Scale Uses of 
Organisms Containing Recombinant DNA 
Molecules, should be used. 
The proposal appeared in the March 4, 
1983, Federal Register (48 FR 9437). One 
comment was received during the 
comment period. Dr. Irving S. Johnson of 
Lilly Research Laboratories, a division 
of Eli Lilly and Company, said Eli Lilly 
and Company saw no need to 
incorporate the Large-Scale 
Recommendations into the Guidelines. 
He said other agencies (NIOSH and 
EPA) have the authority to deal with 
manufacturing processes and these 
agencies have undertaken evaluations of 
recombinant DNA activities. 
The RAC evaluated this proposal at 
its April 11, 1983, meeting. Dr. Waitz and 
Dr. Wensink said that incorporating the 
Large-Scale Recommendations into the 
Guidelines would aid investigators and 
IBCs by having all the recommendations 
together in one document. By a vote of 
sixteen in favor, none opposed, and one 
abstention, the RAC recommended this 
action. 
1 accept this recommendation. 
II. Summary of Actions. 
A. Appendix L — Field Testing of 
Genetically Engineered Plants 
Section III— A— 2 is amended to read as 
follows: 
Deliberate release into the environment of 
any organism containing recombinant DNA, 
except certain plants as described in 
Appendix I.. 
A new appendix, Appendix L, is 
added as follows: 
[1321 
