46256 
Federal Register / Vol. 49, No. 227 / Friday. November 23, 1984 / Notices 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
National Institutes of Health 
Recombinant DNA Research; Actions 
Under Guidelines 
AGENCY: 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 
Institutes of Health (NIH), under the 
June 1983 NIH Guidelines for Research 
Involving Recombinant DNA Molecules 
(48 FR 24556). 
EFFECTIVE DATE: November 23, 1984. 
FOR FURTHER INFORMATION CONTACT: 
Additional information can be obtained 
from Dr. William J. Gartland, Office of 
Recombinant DNA Activities (ORDA), 
National Institutes of Health, Bethesda 
Maryland 20205, (301) 469-6051. 
SUPPLEMENTARY INFORMATION: One 
major action under the NIH Guidelines 
for Research Involving Recombinant 
DNA Molecules is being promulgated 
today. This proposed action was 
published for comment in the Federal 
Register of April 24, 1984 (49 FR 17672), 
and reviewed and recommended for 
approval by the NIH Recombinant DNA 
Advisory Committee (RAC) at its 
meeting on June 1, 1984. In accordance 
with Section IV-C-l-b of the NIH 
Guidelines, these actions have been 
found to comply with the Guidelines and 
to present no significant risk to health or 
the environment. 
Part I of this announcement provides 
background information on the action. 
Part II provides a summary of the action 
of the Director, NIH. 
Following this anouncement, there 
appears in a separate section of the 
Federal Register the revised NIH 
Guildelines for Research Involving 
Recombinant DNA Molecules. These 
revised Guidelines differ from the 
previous version of the Guidelines 
promulgated on June 1, 1983 (48 FR 
24556), by incorporating within them: the 
changes in the Guidelines which were 
recommended at the RAC meeting of 
September 19, 1983, and promulgated on 
November 23, 1983 (48 FR 53056); the 
changes recommended at the RAC 
meeting of February 6, 1984, and 
promulgated on April 25, 1984 (49 FR 
17844); and the changes in the 
Guidelines which were recommended at 
the RAC meeting of June 1, 1984, some of 
which were promulgated in the Federal 
Register of September 13, 1984 (49 FR 
36052); and the change in the Guidelines 
which is promulgated in this 
announcement. Minor editorial 
modifications have also been introduced 
into the document. 
I. Decision on Actions Under Guidelines 
Proposal to Amend Appendix G of the 
Guidelines. Physical Containment 
The booklet, Classification of 
Etio logic Agents on the Basis of Hazard 
(U.S. Department of Health, Education, 
and Welfare, Public Health Service, 
Centers for Disease Control, Office of 
Biosafety, Atlanta, Georgia 30333), has 
served since 1969 as a general reference 
for laboratory activities utilizing 
infectious agents. The fourth edition of 
that booklet (July 1974) was included in 
the 1978 version of the NIH Guidelines 
for Research Involving Recombinant 
DNA Molecules and has since been a 
part of those Guidelines as Appendix B. 
Now an "Interagency Working Group" 
constituted by the Centers for Disease 
Control (CDC) and the NIH has 
prepared a new set of guidelines for 
laboratory research with etiologic 
agents. These new guidelines are 
entitled Biosafety in Microbiological 
and Biomedical Laboratories. The CDC / 
NIH guidelines designate four categories 
pf biosafety levels for laboratory 
operation: Biosafety Levels 1, 2, 3, and 4. 
These levels are comparable to the Pi, 
P2, P3, and P4 containment levels 
described in the NIH Guidelines for 
Research Involving Recombinant DNA 
Molecules. 
The CDC/NIH Interagency Working 
Group proposed that RAC consider 
recommending a revision of the 
description of the P levels in the NIH 
Guidelines so that these descriptions 
would correspond to the biosafety levels 
set forth in the document Biosafety in 
Microbiological and Biomedical 
Laboratories. 
The changes necessary to effect this 
change were published in the Federal 
Register of April 24, 1984 (49 FR 17672), 
for thirty days of public comment. One 
comment was received from Mr. C. 
Searle Wadley and Dr. John H. Keene of 
Abbott Laboratories of North Chicago, 
Illinois. Mr. Searle and Dr. Keene wrote 
that: 
* * * acceptance of these proposed 
amendments will serve to unify the concepts 
of potential biohazards with regard to both 
recombinant and nonrecombinant organisms. 
Since RDNA experimentation in many 
instances involves the use of microorganisms, 
the proposed changes in the terminology of 
containment levels will result in a 
consistency of language which is extremely 
important. 
The RAC discussed this proposed 
modification of the NIH Guidelines at its 
June 1, 1984, meeting. During the 
discussion, it was noted that the 
proposed modifications would not 
substantively change that portion of the 
Guidelines dealing with physical 
containment. Appendix G. It would, 
however, establish a commonality of 
language between the Guidelines and 
the safety standards for other 
microbiological research. 
Several questions concerning the 
exact language of the proposed 
modifications to Appendix G were 
raised by RAC. It was pointed out that 
the language of proposed Appendix G- 
II— B— 3— a— { 1 ) referred to “harvesting 
infected tissues from animals or eggs," 
while the language in Appendix G-II-C- 
3-a referred to “harvesting of tissues or 
fluids from experimental animals and 
embryonate eggs." It was asked why the 
word "infected” is not used in the 
Appendix G-II-C specification even 
though appendix G-II-C specifications 
refer to the more stringent BL3 level of 
containment while Appendix G-II-B 
specifications refer to the BL2 level of 
containment. A second question 
concerned the monitoring of the efficacy 
of the UV irradiation required in 
specification appendix G — II— D— 2(1). A 
third question was whether "chewing" is 
considered to be “eating." Finally it was 
asked whether the specification for use 
of self-closing doors could be met by use 
of spring-loaded doors or whether they 
had to be electrical. 
Discussions with the authors of the 
proposed modifications of the language 
of Appendix G led to the following 
conclusions: 
The word “infected" had been 
inadvertently omitted from the language 
of Appendix G-II-C-3-a and will be 
added to that language as part of this 
decision. The word "eating” is used to 
convey the idea of introducing materials 
into the mouth: the specifications 
against “eating” include a prohibition 
against chewing gum, putting pencils or 
fingers in the mouth, sucking on candies 
or lozenges, etc. Doors may be made 
"self-closing" by use of hydraulic or 
electrical devices or by being spring- 
loaded. The intent is to ensure that the 
door closes automatically. Self-closing 
doors are also a fire containment 
measure. The specification in Appendix 
G-II-D-2-(l) refers to use of UV 
irradiation in BL4 high containment 
facilities. In such a carefully monitored 
situation, UV irradiation has been 
proven effective in minimizing aerosol 
exposure within animal facilities. 
By a vote of twenty in favor, none 
opposed, and no abstentions, the RAC 
recommended approval of the proposed 
modifications. I accept this 
[254] 
