Federal Register / Vol. 51, No. 244 / Friday, December 19, 1986 / Notices 
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agency, the submitter shall notify ORDA; 
ORDA may then determine that such review 
serves the same purpose, and based on that 
determination, notify the submitted that no 
RAC review will take place, no N1H approval 
is necessary, and the experiment may 
proceed upon approval from the other 
Federal agency. 
2. Add at the end of section I-A of the 
Guidelines the following paragraph: 
Any recombinant DNA experiment which 
according to these Guidelines requires 
approval by the National Institutes of Health 
(NIH). may be sent by the submitter to the 
N1H or to another Federal agency that has 
jurisdiction for review and approval. Once 
approval for a recombinant DNA experiment 
has been given by a Federal agency other 
than the NIH (whether referred to that agency 
by the NIH. or sent directly there by the 
submitter), the experiment may proceed 
without the necessity for NIH review or 
approval. 
II. Proposed Revision of Section UI-A-2 
of the NIH Guidelines 
Section III-A-2 of the NIH Guidelines 
currently reads as follows: 
III-A-2. Deliberate release into the 
environment of any organism containing 
recombinant DNA, except certain plants 
as described in Appendix L 
At its meeting on September 29, 1986, 
the RAC voted to recommend that 
section III-A-2 be revised to read as 
follows: 
III-A-2. Deliberate release into the 
environment of any organism containing 
recombinant DNA except: 
a. Certain plants as described in 
Appendix L 
b. Deletion derivatives not otherwise 
covered by these Guidelines. 
c. Organisms covered in exemption 
ui-d-2. 
This recommendation has not yet 
been acted upon by the Director, NIH, 
and therefore has not yet been 
incorporated into the NIH Guidelines. 
The RAC Working Group on 
Definitions met on December 5, 1986, 
and recommended that section III-A-2 
be amended to read as follows: 
III-A-2. Deliberate release into the 
environment of any organism containing 
recombinant DNA except those listed 
below. The term “deliberate release" is 
defined as a planned introduction of 
recombinant DNA-containing 
microorganisms, plants, or animals into 
the environment. 
a. Introductions conducted under 
conditions considered to be accepted 
scientific practices in which there is 
adequate evidence of biological and/or 
physical control of the recombinant 
DNA-containing organisms. The nature 
of such evidence is described in 
Appendices L. M, N. and O. 
b. Deletion derivatives not otherwise 
covered by these Guidelines. 
c. Organisms covered in exemption 
III-D-2. 
It was the intent of the working group 
that Appendix L would be the current 
Appendix L dealing with plants with 
future changes to be recommended by 
the RAC. Appendices M, N, and O 
would be parallel sections, to be written, 
covering respectively animals, 
microorganisms other than vaccines, 
and vaccines. 
The minutes of the December 5, 1986, 
meeting of the working group will be 
available prior to the February 2. 1986. 
RAC meeting. 
m. Proposed Revision of Section I-B or 
Section m-A-2 of the NIH Guidelines 
The RAC Working Group on 
Definitions at its meeting on December 
5, 1986, passed the following motion 
with regard to the definition of 
recombinant DNA: 
The working group agreed with the 
concept that certain types of 
recombinant DNA experiments which 
do not involve the introduction of 
foreign DNA need not be subjected to 
special regulation as “recombinant 
DNA." The working group were split as 
to whether they preferred dealing with 
this problem by changing the definition 
of recombinant DNA or by further 
modifications of other sections of the 
Guidelines (e.g- those in IH-A-2). 
Therefore, the working group presents 
the following two options for public 
comment and RAC consideration: 
1. Change definition of recombinant 
DNA: 
"The first paragraph of section I-B 
would be revised to read as follows 
(new words in italics): 
In the context of these Guidelines, 
recombinant DNA molecules are defined 
as either (i) molecules which are 
constructed outside living cells by 
joining foreign natural or foreign 
synthetic DNA segments to DNA 
molecules that can replicate in a living 
cell, or (ii) DNA molecules that result 
from the replication of those described 
in (i) above. 
The following new footnote would be 
added at the word “foreign": 
Rearrangements involving the introduction 
of DNA from different organisms or different 
strains of an organism will be considered 
recombinant DNA. Deletions, single-base 
changes and rearrangements within a single 
genome will not involve the introduction of 
foreign DNA and therefore would not be 
considered recombinant DNA. 
2. Modify Section III-A-2 to read as 
follows: 
III-A-2. Deliberate release into the 
environment of any organism containing 
recombinant DNA except those listed 
below. The term "deliberate release” is 
defined as a planned introduction of 
recombinant DNA-containing micro- 
organisms. plants, or animals into the 
environment. 
a. Introductions conducted under 
conditions considered to be accepted 
scientific practices in which there is 
adequate evidence of biological and/or 
physical control of the recombinant 
DNA-containing organisms. The nature 
of such evidence is described in 
Appendices L, M. N, and O. 
b. Deletion derivatives and single 
base changes not otherwise covered by 
the Guidelines. 
c. Rearrangements and amplification 
within a single genome. Rearrangements 
involving the introduction of DNA from 
different strains of the same organism 
would not be covered by this exemption. 
The minutes of the December 5, 1986, 
meeting of the Working Group on 
Definitions will be available prior to the 
February 2, 1986, RAC meeting. 
IV. Proposed Revisions of Appendices 
C-II, C-m, and C-IV 
Dr. Frank E. Young, Commissioner of 
Food and Drugs, has submitted the 
following proposed revisions of 
Appendices C-H, C-QI, and C-IV, and 
rationale: 
On June 26, 1986, a major statement of 
federal policy, the "Coordinated 
Framework for Regulation of 
Biotechnolgy”, was published (51 FR 
23301-93). We believe that important 
clarifications of regulatory policy are to 
be found there, but that some minor 
changes in the NIH Guidelines are 
required for consistency and clarity. 
As noted on page 23304 of the June 28 
document. Appendices C-H. C-M, and 
C-IV of the NIH Guidelines contain the 
statement that: 
For large-scale (LS) fermentation 
experiments BLl-LS physical containment 
conditions are recommended. However, 
following review by the IBC of appropriate 
data for a particular host-vector system, some 
latitude in the application of 3L1-LS 
requirements as outlined in Appendix K-II-A 
through K-II-F is permitted. 
The document continues: 
The appropriate large-scale containment 
requirements for many low-risk [r]DNA 
derived industrial microorganisms will be no 
greater than those appropriate for the 
unmodified parental organisms. 
Together, these statements imply that 
the actions of fBCs should ensure that 
requirements for physical containment 
of low-risk microorganisms should be 
appropriately minimal, i.e., only those 
that are employed routinely for 
organisms such as E. coli K-12, B. 
subtilis, or Saccharomyces cerevisiae. It 
should be noted that industrial 
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