33132 
NOTICES 
tions has resulted In changes in the 
IBC membership requirements. 
Noninstitutional representation is 
now proposed on biosafety commit- 
tees, going beyond the PRG-RAC. 
The role and responsibilities of the 
local biosafety committees have been 
restated and refined in response to nu- 
merous comments. They are also 
strengthened by the required member- 
ship of the biosafety officer. The 
PRG-RAC proposed the designation 
of a biological safety officer for each 
Institution where P3- and P4-level re- 
combinant DNA research was conduct- 
ed, reflecting the practice of a growing 
number of American Institutions and 
the recommendations of the British 
"Williams Committee Report." The re- 
quirement is intended to insure that a 
clearly designated Individual will have 
the primary administrative responsi- 
bility for the Implementation of insti- 
tutional policies and biosafety commit- 
tee decisions. 
A related issue which drew several 
comments and recommendations con- 
cerned medical surveillance, or health 
monitoring. Responsibility for deter- 
mining medical surveillance proce- 
dures for research personnel was 
transferred from the principal Investi- 
gator to the Institution, because the 
RAC felt that institutions would have 
access to a broader range of expertise. 
Specific Information on medical con- 
ditions was moved to the laboratory 
safety monograph, which includes ad- 
dltinal recommendations on health 
monitoring and program content. Gen- 
eral language describing the elements 
of a medical surveillance program was 
retained in Part IV as part of the insti- 
tution's responsibility. 
The addition of information and the 
further emphasis on health monitor- 
ing should enhance occupational 
health and safety at the local level. It 
should be noted that a collaborative 
effort is underway between NIH and 
the Center for Disease Control to es- 
tablish a mechanism for providing 
emergency teams of experts to re- 
spond to major laboratory accidents. 
Probably no other issue generated as 
much comment as that of training. Ac- 
cording to one commentator, training 
"probably represents the key to 
safety." He goes on to say that any 
break in technique could destroy phys- 
ical containment procedures. Indeed, 
training in good microbiological prac- 
tices could be considered the first line 
of defense, as it serves to protect the 
worker as well as prevent contamina- 
tion of the environment inside and 
outside the laboratory. The PRG-RAC 
proposed the addition of a require- 
ment for the training of research per- 
sonnel In the use of good microbiologi- 
cal technique. In the PRG-NIH. the 
principal investigator must be trained, 
and must insure the training of labo- 
ratory personnel, before undertaking 
recombinant DNA experiments. The 
laboratory safety monograph includes 
a section on "Laboratory Techniques 
for Biohazard Control” which de- 
scribes good practices regarding pipet- 
ting, centrifuging, and the use of sy- 
ringes and needles. Altogether, train- 
ing requirement s have been further 
emphasized and strengthened in the 
PRG NIH. 
Several commentators wanted train- 
ing standards to be set In the Guide- 
lines or by NIH. the institution, or the 
biosafety committees. Others opposed 
setting standards. Still others recom- 
mended mandatory, formal evaluation 
and certification of investigators to 
test for competency in microbiological 
techniques. NIH is currently funding a 
Working Panel of the American Soci- 
ety of Microbiology (ASM) which is 
considering standards of training in 
microbiological techniques for recom- 
binant DNA research. Plans call for 
the dissemination of a report for the 
use of Institutions. IBC's. and princi- 
pal investigators, once NIH receives 
the recommendation of the ASM 
Panel. 
NIH considers It premature to re- 
quire national certification, as suggest- 
ed by some. There are so few models 
for formal training standards in bio- 
medical research that NIH has decided 
to proceed cautiously, while continu- 
ing to promote safety training. As yet, 
there is no consensus, no one best way 
to accomplish this training, and there- 
fore the desired results may best be 
achieved by allowing institutions, bio- 
safety committees, and investigators 
some flexibility. Meanwhile. NIH 
plans to develop courses to be based 
on the NIH/ASM standards and to 
offer them widely. The Laboratory 
Safety Monograph also contains a 
summary of safety training aids, mate- 
rials, and courses offered by the NIH 
and others. 
From the discussion of these issues, 
it should be evident that measures 
have been undertaken in the revision 
of Part IV of the Guidelines to empha- 
size occupational health and safety. 
The principal measures would be the 
strengthening of training require- 
ments and activities, the designation 
of someone in the institution as a 
member of the biosafety committee to 
handle biological safety questions gen- 
erally, the delegation of more authori- 
ty to the institution, and better defini- 
tion of responsibilities at the local 
level. The impact of these actions will 
be the promotion of safer conduct of 
this research, thus affording a greater 
measure of protection to the environ- 
ment. 
In summary, a key focus of public 
comment was on “procedural due proc- 
ess” to insure public participation in 
the development of NIH recombinant 
DNA policies. In response to those 
suggestions in several instances, op- 
portunity for public comment is af- 
forded through activities of the Direc- 
tor. NIH, and the RAC. In addition, 
public representation on the RAC will 
be considered further, with a nomina- 
tion process to insure a wide range of 
individuals for selection. New general 
compliance and registration sections 
have been included in the PRG-NIH 
that do not appear in the current 
Guidelines. These sections are directly 
responsive to stated concerns that the 
importance of these safety standards 
and procedures be emphasized. 
NIH will continue to work closely 
w'ith other relevant research and regu- 
latory agencies, particularly the Envi- 
ronmental Protection Agency and the 
Occupational Safety and Health Ad- 
ministration. Both of these agencies 
are represented on the Federal Inter- 
agency Committee on Recombinant 
DNA Research. 
NIH has created over the past 2 
years several internal committees that 
are critically examining areas where 
work with potential biohazards is in- 
volved in the laboratory. 
Finally, a key concern of all com- 
mentators was the need for programs 
in occupational and environmental 
safety which would Include health sur- 
veillance for laboratory personnel and 
the community. Recombinant DNA re- 
search policies have stimulated a 
broad NIH commitment and interest 
In laboratory safety. NIH has a man- 
date for national leadership in labora- 
tory safety programs, and the pro- 
posed revisions reflect full acceptance 
of that responsibility. 
Appendix A-l 
Table: Comparison of Containment 
Levels 
The following table compares the 
containment levels for all permissible 
types of recombinant DNA experi- 
ments. It designates the levels under 
the Guidelines now in effect (since 
June 1976), under those proposed by 
the RAC (September 1977), and under 
the present NIH-proposed revisions. 
A dash (— ) indicates that the catego- 
ry is not classified in the edition of the 
Guidelines under which the dash ap- 
pears. 
It should be stressed that the table 
is not definitive, since the contain- 
ment levels of the Guidelines have 
been redefined and other require- 
ments modified. 
FEDERAL REOISTER, VOL 43, NO. 146— FRIDAY, JULY 38, 1978 
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