7438 Federal Register 
DEPARTMENT OF HEALTH AND 
HU?/AN SERVICES 
- National Institutes of Health 
Recombinant DNA Research; Actions 
Under Guidelines 
agency: National Institutes of Health. 
PHS. DHHS. 
action: Notice of Actions Under the 
NIH Guidelines for Research Involving 
Recombinant DNA Molecules. 
summary: This notice sets forth six 
actions to be taken by the Director. 
National Institutes of Health (Nll i), 
under the May ", 1986. NIH Guidelines 
for Research Involving Recombinant 
DNA Molecules (51 FR 16958). 
EFFECTIVE DATE: March 1. 1990. 
FOR FURTHER INFORMATION CONTACT; 
Additional information can be obtained 
from Dr. Nelson A. VVivel. Director. 
Office of Recombinant DNA Activities. 
Ofiice of Science Policy and Legislation. 
National Institutes of Health. Building 
31. room 4E11. Bethesda. Maryland 
20892. (301) 49G-983S. 
SUPPLEMENTARY INFORMATION: Today 
six actions arc being' p : umu lgaTed under 
the NIK Guidelines for Research 
Involving Recombinant DN.A Molecules. 
These six proposed actioris were 
published for comment in the Federal 
Register of December 19. 1986 (51 FR 
45650): December 3tX 1988 (53 FR 53262];, 
September 1. 1989 (54 FR 3653Q).. January 
4. 1990 (55 FR 393); January 22. 1990 (55 
FR 2152).. and reviewed aad 
recommended for approval by tiie NIH 
Recombinant DNA Advisory Committee 
(RAC) at its meetings on February 2. 
1987, January 30, 1989. October 6. 1989. 
• end February’ 5. 1990. 
L Background Information and 
Decisions on. Actioa Under the. NIH 
Guidelines 
A. Proposed Revision of Section III-A-Z 
of the NIH Guidelines 
The RAC W'orking Group on 
Definition.s at its meeting on December 
5. 1936. 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 “jecombinant 
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 
NIH Guidelines (e.g., those in UI-A-2). 
Vol. 55. No. 41 / Tnursday, March 
Therefore- the working group presented 
the following two options for public 
comment and RAC consideration; 
1. Change definition of recombmanf 
DNA: 
■ The first paragraph of section 1-5 would be 
revised to read as follows (new words 
bolded): 
In the conte.\t 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 orefifTerent 
strains of an organism will be considered 
recombinant DNA Deletions, single-base 
clianges and rearrangements within a aingle 
genome wrill not involve the introcfiiction of 
foreign DNA and therefore would not be 
considered recombinant DNA 
2. Modify section IU-A-2 to read as 
follows: 
ni-A-2. Deliberate release into the 
environment of any organism containing 
recombinant D.NA except those listed below. 
The term "deliberate release" is defined as a 
planned introdnetion of recombinant DNAr 
containing micro-org.vnisms. plants, or 
animals into tbe environment 
a. Introductions conducted under 
conditions considered to be accepted 
adentifier practices in which there is adequate 
evidence ofbiologica! and/or physical 
control of the recembinant DNA-containing 
organisms. The nature of such evidences 
described in Appendices L M. N. and Q. 
b. Deletion derivatives and single base 
changes not otherwise covered by tbe 
Gufdelines. 
c Rearrangements and amplificatfon 
withina single genome. Rearrangements 
involving the introducHon of DNA from, 
different strains of the same organism would 
not be covered by this exemption. 
This proposal was published tor 
comment in the Federal Register of 
December 19. 1986 (51 FR 45650J- 
The RAC considered this proposal at 
the February 2, 1987, meeting. 
The RAC by a vote of 11 in favor. 4 
opposed, and 1 abstention, accepted the 
following motion: 
ni-.\-2. Deliberate release into the 
environment of auty organism contsiiung 
recombinant D.NA except those listed below. 
The term 'deliberate release' is defined as a 
, planned introduction of recombinant DNA- 
Contaming mtcio-organisms. plants, or 
aiumals into the envi.*onment. 
ni-A-2-a. Introductions conducted under 
conditions considered to be accepted 
scientific practices in which there inadequate 
evidence of biological and/or physfeat 
control of the recombinant DNA-confafnfng 
1, 1990 / Notices 
organisms. The nature of such evidence 's 
. described in Appendices L M. N. and O. 
ni-A-2-b. Deletion derivates and single 
Erase changes not otherwise covered by the 
Guidelines. 
UI-A-2-C For extrachromosomal elements 
and microorganisms (including viruses), 
rearrangements and amplifications within a 
single genome. Rearrangements involving the 
introduction of D.NA from different strains of 
■ the-same species would not be covered by 
this exemption. 
I accept this recommendation and 
Section III-A-2 has been modified 
accordingly. 
B. Public Infon-nation Brochure — “Gene 
Therapy for Human Patients " 
The Human Gene Therapy 
Subcommittee of the Recombinant DNA 
Advisory Committee has developed a 
document to be used in educating the 
nonscientific public about human gene 
therapy. The information brochure 
mcludes background material about the 
purposes and potential of research in 
gene therapy, about its supenrision. and 
about why and how the public is 
involved. 
The announcement of the revie’.v of 
&is brochure was initially published in 
tbe Federal Register of December 20, 
1988 (53 FR 53262), prior to a scheduled 
RAC meeting on January 30, 1989. 
After minor revisions, the RAC voted 
to approve the following version as the 
final form of the document by a vote of 
23 in favor, none opposed, and no 
abstentions: 
Gene Therapy for Human Patients 
Infonnatioa for the General Public 
This brochure provides basic information 
for the nonscientific public about 
experiments intended to cure disease through 
* transplantation of genes into the 
nonreproductive (somatic] cells of human 
patients. It includes background material 
about human gene therapy and its purposes 
and potential, about supervision of the 
research, and about why and how the public 
is involved. 
While this brochure is intended primarily 
as educational materiaL in some instances it 
wilt be circulated by the National Institutes 
of Health together with the Points to Consider 
fai the Design and Submission of Protocols for 
the Transfer of Recombinant DNA into the 
Genome of Human Subjects. 
Gerard ). McCerrity. Ph.D.. Chair. 
Recombinant DNA Advisory Committee. 
LeRoy Walters. Ph.D.. Chair. Hu.man Gene 
Therapy Subcommittee 
March 1990 
. -PREFACE : 
As a result of recent advances in medical 
science. researchers believe that a gene can 
be transplanted into human bemgs who suffer 
from severe diseases. Such gene transplants 
may alleviate or perhaps even cure diseases 
for which no adequate treatment now exists. 
[ 40 ] 
Recombinant DNA Research, Volume 14 
