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proceed without Recombinant DNA 
Advisory Committee and NIH approval 
if it has been reviewed and approved by 
another Federal agency that has 
jurisdiction over such a proposal. The 
amended version (52 FR 31849) of 
Section I reads as follows: 
Section 1-A. Purpose 
• 'Any recombinant DNA 
experiment, which according to the NIH 
Guidelines requires approval by the 
NIH. must be submitted to the NIH or 
to another Federal agency that has 
jurisdiction for review and approval. 
Once approval, or other applicable 
clearances, have been obtained from a 
Federal agency other than the NIH 
(whether the experiment is 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* * *.” 
On December 6, 1990, the 
Recombinant DNA Advisory Committee 
Pl annin g Subcommittee recommended 
that the requirement for Recombinant 
DNA Advisory Committee review of 
experiments involving deliberate 
environmental release of organisms 
containing recombinant DNA be 
eliminated from the NIH Guidelines. 
This recommendation reflected the fact 
that the Federal regulatory agencies, the 
U.S. Department of Agriculture and the 
invironmental Protection Agency, are 
responsible for the review and approval 
of environmental release experiments. 
The Recombinant DNA Advisory 
Committee reviewed the request and 
recommended that the following 
sections be deleted from the NIH 
Guidelines (Actions Under the 
Guidelines, Federal Register, July 5, 
Part ni): 
Section IlI-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 enviroiunent. 
Section III-A-2-a. Introductions 
conducted under conditions considered 
to be accepted scientific practices in 
which there is adeauate evidence of 
biological and/or physical control of the 
recombinant DNA-containing 
organisms. The nature of such evidence 
is described in Appendix L. 
Section UI-A-2-^. Deletion 
derivatives and single base changes not 
otherwise covered by the NiH 
uidelines. 
Section IH-A-2-C. For 
extrachromosomal elements and 
microorganisms (including viruses), 
rearrangements and amplifications 
within a single genome. Rearrangements 
involving the introduction of DNA from 
different strains of the same species 
would not be covered by this 
exemption.” 
Based on these amendments to the 
NIH Guidelines, that have previously 
been recommended by the Recombinant 
DNA Advisory Committee, and the fact 
that the principles of planned 
introduction are now in place which 
provide a risk-assessment method by 
other Federal regulatory agencies, the 
Office of Recombinant DNA Activities 
requests that Appendix L be deleted 
from the NIH Guidelines. 
Appendix L will be deleted as 
follows: 
Appendix L. Release into the Environment of 
Certain Plants 
Appendix L-I. General Information 
Appendix L specifies conditions under 
which certain plants as specified below, may 
be approved for release into the environment. 
Experiments in this category cannot be 
initiated without submission of relevant 
information on the proposed experiment to 
NIH, review by the RAC Plant Subcommittee, 
and specific approval by the NIH Director. 
Such experiments also require the approval 
of the Institutional Biosafety Committee 
before initiation. 
Appendix L-II. Criteria Allowing Review by 
the RAC Plant Subcommittee Without the 
Requirement for Full RAC Review 
“In consultation with the RAC Plant 
Subcommittee and without the requirement 
for full RAC review (Institutional Biosafety 
Cormnittee review and approval is 
necessary), NIH/ORDA may approve the 
growing of plants containing recombinant 
DNA in the field under the following 
conditions: (i) the plant species is a 
cultivated crop of a genus that has no species 
known to be a noxious weed; (ii) the 
introduced DNA consists of well- 
characteri 2 :ed genes containing no sequences 
harmful to humans, animals, or plants; (iii) 
the vector consists of DNA from exempt host- 
vector systems (see Appendix C), frx>m plants 
of the same or closely related species, from 
nonpathogenic prokiuyotes or nonpathogenic 
lower eukaryotic plants, from plant 
pathogens only if sequences resulting in 
production of disease symptoms have been 
deleted, or chimeric vectors constructed from 
sequences of exempt host-vector systems (see 
Appendix C) or from sequences from plant 
pathogens in which the disease symptoms 
have been deleted. The DNA may be 
introduced by any suitable method. If 
sequences resulting in production of disease 
symptoms are retained for purposes of 
introducing the DNA into the plant, 
greenhouse-grown plants must be shown to 
be free of such sequences before such plants, 
their derivatives, or seed can be used in field 
tests; (iv) plants are grown in controlled 
access fields under specified conditions 
appropriate for the plant under study and the 
geographical location. Such conditions 
should include provisions for using good 
cultural and pest control practices, for 
physical isolation from plants of the same 
species outside of the experimental plot in 
accordance with pollination characteristics of 
the species, and the prevention of plants 
containing recombinant DNA frnm becoming 
established in the environment. Review by 
the Institutional Biosafety Committee should 
include an appraisal by scientists 
knowledgeable of the crop, its production 
practices, and the local geographical 
conditions. Procedures for assessing 
alterations in and the spread of organisms 
containing recombinant DNA must be 
developed. The results of the outlined tests 
must be submitted for review and approval 
by the Institutional Biosafety Committee. 
Copies of such results must be submitted to 
the Office of Recombinant DNA Activities, 
National Institutes of Health, Building 31, 
Room 4B11, Bethesda, Maryland 20892, (301) 
496-9838.” 
The proposed amendment was 
reviewed by the Recombinant DNA 
Advisory Committee during its June 9- 
10, 1994, meeting. The Recombinant 
DNA Advisory Committee approved a 
motion to accept the deletion of 
Appendix L, Regarding Release into the 
Environment, by a vote of 13 in favor, 
0 opposed, and no abstentions. 
I accept this recommendation, and 
Appiendix L, Regarding Release into the 
Enviroiunent, of the NIH Guidelines will be 
deleted accordingly. 
II. Summary of Actions 
A. Amendment to Appendix M-I-D of 
the NIH Guidelines Regarding Informed 
Consent for Human Gene Transfer 
Protocols 
Appendix M-I-D will read as follows; 
Appendix M-I-D. Informed Consent 
in accordance with the requirements of 
DHHS regulations for the Protection of 
Human Subjects (45 CFR Part 46), 
investigators should indicate how subjects 
will be informed about the proposed study 
and the manner in which their consent will 
be solicited. They should also indicate how 
the Informed Consent document makes clear 
the special requirements of gene transfer 
research. 
Appendix M-I-D-t. Communication About 
the Study to Potential Participants 
Appendix M-I-D-l-a 
Which members of the research group and/ 
or institution will be responsible for 
contacting potential participants and for 
describing the study to them? What 
procedures will be used to avoid possible 
conflicts of Interest if the investigator is also 
providing medical care to potential subjects? 
Appendix M-I-D-l-b 
How will the major points covered in 
Appendices M-I-A through M-l-C be 
disclosed to potential participants and/or 
their parents or guardians in language that is 
understandable to them? 
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