Federal Register / Vol. 54, No. 47 / Monday, March 13, 1989 / Notices 
10509 
ThiB Includes research perfonned by the NIH 
directly. 
An individual receiving support for 
research involving recombinant DNA must be 
associated with or sponsored by an 
institutiob that can and does assume the 
responsibilities assigned in these Guidelines. 
Ihe Guidelines are also applicable to 
projects done abroad if they are suported by 
NIH funds. If the host counrty. however, has 
established rules for the conduct of 
recombinant DNA projects, then a certificate 
of compliance with those rules may be 
submitted to NIH in lieu of compliance with 
the NIH Guidelines. The NTH reserves the 
right to withhold funding if the safety 
practices to be employed abroad are not 
reasonably consistent with the NIH 
Guidelines. 
In a letter date January 9, 1987, Mr. 
Edward Lee Rogers, Counsel for the 
Foundation on Economic Trends, and 
Mr. Jeremy Rifkin, Foundation on 
Economic Trends, Washington. DC, 
proposed that the following text be 
inserted after the first sentence of the 
third paragraph of section I-C; 
For purposes of the preceding sentence, the 
term ‘project’ includes any research or 
development of the recombinant organism or 
other product or process in question, 
including all such work that is reasonably 
foreseeable when the NIH support is 
received. NIH support includes both money 
^ants and any t]^e of in-kind support, 
including resear^ conducted directly by 
NIH. supplies, equipment the use of facilities, 
and biological research materials. NIH 
support has been given where the source of 
funds or in-kind support is, directly or 
indirectly, the NIH. 
This proposed amendment of section 
I-C was initially published for comment 
in the Federal Register of March 11, 1987 
(52 FR 7525J, prior to a scheduled RAC 
meeting on June 15, 1987. The June 15, 
1987, meeting was postponed and 
rescheduled on September 21 , 1987. - 
Accordingly, this proposed amendment 
was published again for comment in the 
Federal Register of August 11, 1987 (52 
FR 29800). 
After extensive discussion at its 
meeting on September 21. 1987, the RAC 
voted to establish a working group to 
make recommendations regarding 
international projects and to report back 
to the full RAC. . 
A Working Group on International ■ 
Projects met at the NIH on February 1, 
1988 (53 FR 808). After much discussion, 
the working group voted seven in favor, 
none opposed, and no abstentions that 
the following proposed revision of the 
last paragraph of Section I-C be 
published for comment: 
The NIH Guidelines are also applicable: (1) 
To projects done abroad if they are supported 
by NIH funds, or (2) to research done abroad 
if it involves deliberate release into the 
environment or testing in humans of 
materials containing recombinant DNA 
developed with NIH funds and the research 
is a direct extension of the development 
process. If the host country, however, has 
established rules for the conduct of 
-recombinant DNA projects, then a written 
assurance of compliance with those rules 
may be submitted to NIH in lieu of 
compliance with the NIH Guidelines. 
Alternatively, if the host country does not 
have such rules, written acceptance by an 
appropriate government office of the host 
country is necessary in lieu of compliance 
with the NIH Guidelines. The NIH reserves 
the right to withhold funding if the safety 
practices to be employed abroad are not 
reasonably consistent with the NIH 
Guidelines. 
After extensive discussion of this 
proposed amendment of Section I-G and 
attempts to draft revised language, the 
RAC recommended that the many issues 
raised be referred back to the working 
group for further consideration. 
A Working Group on International 
Projects met at the NIH on August 15, 
1988 (53 FR 27570). The working group 
recommended that the following 
proposed revision of the last paragraph 
of Section I-C be published for 
comment: 
The NIH Guidelines are also applicable to 
recombinant DNA projects done abroad: 
1. If they are supported by NIH funds; or 
2. If they involve deliberate release into the 
environment or testing in humans of 
materials containing recombinant DNA 
developed with NIH funds, if the 
institution that developed those materials 
sponsors or participates in those projects. 
Participation includes research collaboration 
or contractural agreements, but not mere 
provison of research materials. 
If the host country has established rules for 
the conduct of recombinant DNA projects, 
then the project must be in compliance with 
those rules. If the host country does not have 
such rules, the proposed project must be 
reviewed by an NIH-approved IBC or 
equivalent review body and accepted in 
writing by an appropriate national 
governmental authority. The safety practices 
to be employed abroad must be reasonably 
consistent with the NIH Guidelines. 
The proposed language was published 
for public comment in the Federal 
Register on September 2, 1988 (53 FR 
3424S). No comments were received in 
response to the notice. This language 
was reviewed at the October 3. 1988, 
RAC meeting and accepted with one 
modification. After the word “authority" 
in the final paragraph, the phrase "of the 
host country" was added. This motion 
passed unanimously by a vote of 20 in 
favor, none oppose^ and no 
abstentions. 
I accept these recommendations, and 
Section I-C has been amended 
accordingly. 
C. Proposed Amendment of Section I-D 
RAC member. Dr. Aime Vidaver of the 
University of Nebraska, proposed that 
the following paragraph regarding 
transposons be added to Section I-B, 
Definition of Recombinant DNA 
Molecules: 
Unmodified transposons (wild-type) that 
become inserted into a genome, even if 
carried by a recombinant vector or plasmid, 
are not subject to these guidelines. For 
example, it is common to use vectors that 
either are naturally unstable (suicide vector) 
in a desired host or that can be rendered 
unstable by manipulating physiological 
conditions. In the process of suicide (inability 
of the vector to replicate), transpqson 
transfer may occur. This process is not 
considered recombinant DNA. 
Transposable genetic elements or 
transposons are mobile DNA segments 
that can insert into a few or several sites 
in a genome. Such insertions, unlike 
classical recombination events, do not 
require DNA sequence homology and 
are independent of recombination 
systems. Many transposons have been 
discovered in microorganisms and other 
organisms. They may be insertion 
sequences that do not carry genes 
related to a phenotype such as drug 
resistance, lactose or raffinose 
utilization, arginine biosynthesis, 
mercury resistance, or enterotoxin 
production. Transposable elements also 
include self-replicating elements such as 
the entire bacteriophage genomes of Mu 
and Psi. 
This proposal appeared in the Federal 
Register on September 2. 1983 (53 FR 
34246), for public comment. Two 
suggestions for modifying the proposed 
language were received and discussed 
..at the October 3, 1988, RAC meeting. 
A substitute motion was developed as 
follows: 
Genomic DNA of plants and bacteria that 
has acquired a transposable element even if 
the latter was donated from a recombinant 
vector no longer present is not subject to 
these Guidelines unless the transposon itself 
contains recombinant DNA. 
The motion to recommend approval of 
this modification to Section I-B of the 
Guidelines was passed by a vote of 18 in 
favor, none opposed, and no 
abstentions. 
I accept this recommendation, and 
Section I-B of the Guidelines is 
amended accordingly. 
n. Summary of Actions 
A. Human Gene Transfer Proposal 
The following section is added to 
Appendix D: 
Appendix D-XHI 
Recombinant DNA Research, Volume 14 
[37] 
