38040 Federal Register 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
National Institutes of Health 
Recombinant DNA Research; Actions 
Under Guidelines 
aocncy: National Institutes of Health, 
PHS. DHHS. 
action: Notice of actions under NIH 
Guidelines for Research Involving 
Recombinant DNA Molecules. 
summary: This notice sets forth actions 
taken by the Director. National Institute 
of Allergy and Infectious Diseases, by 
authority of the Director, NIH, under the 
April 1982 Guidelines for Research 
Involving Recombinant DNA Molecules 
(47 FR 17180). 
ERSCCnvE OATC August 27, 1982. 
FOR FURTHER INFORMATION CONTACT: 
Additional information can be obtained 
from Dr. William ). Gartland. Office of 
Recombinant DNA Activities (ORDA), 
National Institutes of Health. Bethesda, 
Maryland 20205 (301) 496-6051. 
SUPPLEMENT ARY INFORMATION: I am 
promulgating today a major action under 
' the NIH Guidelines for Research 
Involving Recombinant DNA Molecules. 
This action Involves a major revision of 
the Guidelines. In accordance with 
Section IV-E-l-b of the Guidelines. I 
And that this action complies with the 
Guidelines and presents no significant 
risk to health or the environment. 
The structure of this announcement is 
as follows: 
I. Background. 
D. Draft Minute* of june 28. 1982. Meeting 
of the Recombinant DNA Advisory 
Committee (RAC). 
□I. Response of Director. NIAID. to the 
RAC Recommendation*. 
IV. Additional Change*. 
Immediately following this 
announcement, there appears in 
separate section of the Federal Register 
the revised NIH Guidelines for Research 
Involving Recombinant DNA Molecules. 
L Background 
The Recombinant DNA Advisory 
Committee (RAC) at its February 8-9. 
1962 meeting, recommended that the 
National Institutes of Health (NIH) 
accept a proposed modirication (46 FR 
59734) of the NIH Guidelines for 
Research Involving Recombinant DNA 
Molecules. In supporting this 
modirication, the RAC recommended 
that a working group be formed to 
simplify further and modify the 
document. On April 21. 1982, the NIH 
promulgated the revised Guidelines (47 
FR 17100). 
/ Vol. 47, No. 167 / Friday, August 27, 
An ad hoc Working Group on 
Revision of the Guidelines was formed 
and convened for a meeting on April 19, 
1982. The committee addressed several 
issues at this meeting. This first topic 
was an attempt to improve the 
"presentation" of the Guidelines. It was 
felt that most of Section II, which 
describes physical and biological 
containment standards, as well as 
shipping, should be moved to three 
separate new Appendices (C, H, and I). 
In addition, the section describing 
shipment (currently II-C) should be 
expanded to include further information 
on packaging and labeling. It was noted 
that the current Guidelines provide little 
concrete guidance for shipping 
materials; rather, they refer the reader to 
other sources. 
Language describing "General 
Applicability" and "General 
Definitions” should be removed from 
Section IV and placed in Section I. 
The working group discussed the 
question of whether the language of 
Action IIl-A-1 and Appendix F which 
refers to "toxins” also applies to other 
pharmacologically active molecules. A 
correspondent had questioned whether 
"pharmacologically active molecules" 
such as certain hormones should be 
treated as toxins. Pointing to Section I- 
B, second paragraph, which cites; "a 
toxin or a pharmacologically active 
agent.” the working group agreed that 
the intent of the Guidelines is to cover 
these types of molecules and 
recommended that the language dealing 
with toxins in the Guidelines be 
amended to reflect that intent. 
The working group discussed the issue 
of which document should be utilized to 
determine the pathogenic classification 
of an organism. The original 1976 
Guidelines used the publication 
Classification of Etiologic Agents on the 
Basis of Hazard, 4th edition. July 1974; 
U.S. Department of Health, Education 
and Welfare, Public Health Service. 
Center for Disease Control, as the 
reference source for classification of 
microorganisms for the purposes of the 
Guidelines. All subsequent revisions of 
the Guidelines have also used this 
document. At the present time, the 
Centers for Disease Control (CDC) and 
the NIH are engaged in an effort to 
revise the Classification of Etiologic 
Agents on the Basis of Hazard. The 
working group felt, however, that this 
revised version might not serve the 
purposes of the Guidelines as well as 
the original 1974 version. Nonetheless, 
the working group noted that additional 
pathogens should be added to the 
classification in the Guidelines and that 
the classification should be updated 
regularly. It was also noted that some 
1982 / Notices 
organisms might better be treated in a 
manner specific for the purposes of the 
Guidelines. The working group 
recommended, therefore, that the RAC 
and NTH adopt for the Guidelines a 
revised version of the 1974 CDC 
classification, and that the RAC should 
assume responsibility for regularly 
updating the listing. The working group 
recommended that (a) the following 
bacteria be added to the list of Class 2 
bacterial agents; 
Aeromonas hydrophila 
Campylobacter fetus 
Campylobacter jejuni 
Edwardsiella tarda 
Yersinia enterocolitica 
and the listing for Escherichia coli be 
changed to refer to "all 
enteropathogenic, enterotoxigenic, 
enteroinvasive. and strains bearing K1 
antigen;" (b) Vesicular stomatitis virus 
be listed as a Class 2 viral agent rather 
than a Class 3 viral agent; (c) Rabies 
street virus be classified as a Class 3 
viral agent for all procedures; (d) 
Alastrim, Smallpox, and Whitepox 
should be listed as Class 5 viral agents 
rather than as Class 3 and Class 4 
agents as the study of these viruses is 
restricted to a single national facility 
national facility (WHO Collaborating 
Center for Smallpox Research, Centers 
for Disease Control) and the language 
dealing with Poxviruses modified 
accordingly; (e) Viruses classified as 
low risk oncogenic viruses by the 
National Cancer Institute Safety 
Standards for Research Involving 
Oncogenic Viruses (October 1974, U.S. 
Department of Health, Education, and 
Welfare Publication Number (NIH) 75- 
790) should be classified as Class 2 
agents for the purposes of the 
Guidelines; and (f) Moderate-risk 
oncogenic viruses should be classified 
as Class 3 agents for the purposes of the 
Guidelines. Furthermore, footnotes, 
references, and the title of Appendix B 
should be modified to reflect the status 
of a revised Appendix B. 
The working group dealt with the 
issue of the composition of the 
Institutional Biosafety Committees 
(IBCs). A discussion arose as to the 
necessity of stating in current Section 
IV-D-2-a that not less than 20 percent 
of the membership of the IBC shall not 
be affiliated with the institution. It was 
fell that the 20 percent specification 
limits the flexibility of the university in 
appointing members to the IBC. The 
example was offered of an IBC fulfilling 
the 20 percent specification, but wishing 
to add an additional specialist affiliated 
with the university. However, non- 
affiliated representation would fall 
( 541 ] 
