Federal Register / Vol. 69, No," 90 / Wednesday, May 11, 1994 / Notices 
24621 
fonn of persons who can be contacted 
in the event that questions arise during 
the follow-up period. The principal 
investigator should request that subjects 
always keep the laboratory informed of 
a current address and telephone 
number. 
“The subjects should also be informed 
that any significant findings resulting 
from the study will be made known to 
them and/or their parent or guardian 
including new information about the 
experimental procedure, the physical 
reactions experienced by other 
individuals involved in the study, and 
any long-term effects that have b^n 
noted. 
“Part l-D-2-h-(3). Request for 
autopsy. “To obtain vital information 
about the safety and efficacy o(gene 
transfer, subjects should be informed 
that at the time of death, whenever that 
may occur, an autopsy will be requested 
and that they should advise their 
families of this request and of its 
scientific and medical importance. 
Part I-D-2-b-(4). Interest of media 
and others in the research. To alert the 
subjects that others may have an interest 
in the innovative character of the 
exp>eriment and the status of treated 
subjects: 
“The subjects should be informed that 
the institution and investigators will 
make every effort to provide protection 
from the media in an effort to protect 
participants’ privacy; 
“The subjects should be informed that 
representatives of applicable Federal 
agencies (e.g., NIH, Food and Drug 
Administration), representatives of 
collaborating institutions, vector 
suppliers, etc., will have access to 
medical records of the participants." 
XIII. Deletion of Appendix L of the NIH 
Guidelines Regarding Release Into the 
Environmenl/Dr. Wivel 
On April 29, 1994, Dr. Nelson Wivel 
of the Office of Recombinant DNA 
Activities, National Institutes of Health, 
Bethesda, Maryland, requested that 
Appendix L, Release into the 
Environment of Certain Plants, be 
deleted from the NIH Guidelines. 
The Office of Recombinant DNA 
Activities (ORDA) requests that 
Appendix L, Release into the 
Environment of Certain Plants, be 
deleted from the NIH Guidelines based 
on the following: 
(1) Section I of the NIH Guidelines 
allows experiments to proceed that are 
reviewed and approved by another 
Federal agency that has jurisdiction for 
review and approval without the 
necessity for NIH review or approval (52 
FR 31849); 
(2) The Recombinant DNA Advisory 
Committee has not reviewed any 
deliberate release experiment involving 
recombinant DNA since 1984; 
(3) At its May 30-31, 1991, meeting, 
the Recombinant DNA Advisory 
Committee recommended that Section 
in-A-2 be deleted from the NIH 
Guidelines; and 
(4) Experiments involving deliberate 
release into the environment are 
currently reviewed within the 
framework of existing Federal 
regulations, i.e., the Environmental 
Protection Agency (EPA) and the United 
States Department of Agriculture 
(USDA). 
Section I of the NIH Guidelines was 
amended on August 24, 1987, such that 
any recombinant DNA experiment 
(other than human gene transfer) may 
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 I-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, has 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 s, 1990, the 
Recombinant DNA Advisory Committee 
Planning 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 
USDA and EPA, 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: 
Section ni-A-2 
Deliberate release into the 
envirorunent of any organism containing 
recombinant DNA except those listed 
below. The term “deliberate release” is 
defined as a plarmed introduction of 
recombinant DNA-containing 
microorganisms, plants, or animals into 
the environment. 
Section Ill-A-2-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 appendix L. 
Section IIl-A-2-b. Deletion 
derivatives and single base changes not 
otherwise covered by the NIH 
Guidelines. 
Section UI-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 principals of planned 
introduction are now in place which 
provide a risk-assessment method by 
othw 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 Working 
Group, and specific approval by the NIH 
Director. Such expveriments also require the 
approval of the IBC before initiation. 
Information on specific experiments which 
have been approved will be available in 
ORDA and will be listed in appendix L-IIl 
when the Guidelines are republished. 
“Experiments which do not meet the 
specifications of appendix L-II fall under 
section III-A and require RAC review and 
NIH and IBC approval before initiation. 
Appendix L-II. Criteria Allowing Review by 
the RAC Plant Working Group Without the 
Requirement for Full RAC Review 
“Approval may be granted by ORDA in 
consultation with the Plant Working Group 
without the requirement for full RAC review 
(IBC review is also necessary) for growing 
plailts containing recombinant DNA in the 
field under the following conditions: 
Appendix L-II-A. The plant species is a 
cultivated crop of a genus that has no species 
known to be a noxious weed. 
Recombinant DNA Research, Volume 19 
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