NOTICES 
60095 
tion or privacy and propritary inter- 
ests. 
In addition, the IBC is to forward to 
NIH any public comments made on its 
actions and the committee’s response 
to them. And all IBC documents that 
NIH must make available to the 
public, such as the funded research 
proposals, are also to be made availa- 
ble, upon request, at the local level. 
These include reports of serious acci- 
dents and of problems with and viola- 
tions of the Guidelines; also all NIH 
reports to institutions when MU As (in- 
cluding modifications of ongoing pro- 
jects) are not in compliance. Likewise, 
minutes of the IBC meetings and in- 
spection reports will be made availa- 
ble. The intention of the Guidelines in 
all these changes is to enhance public 
accountability at the local level. 
Biological Safety Officer 
There were a number of comments 
concerning the roles and responsibil- 
ities of the Biologial Safety Officer 
(BSO). Several witnesses at the Sep- 
tember 15 hearing recommended that 
whenever recombinant I>NA research 
is being conducted at an institution, 
such an officer be appointed and re- 
quired to serve on the IBC. It was also 
recommended that the BSO have a 
full-time position. The Committee con- 
sidered the role of the BSO at some 
length. 
The Guidelines do specify that all 
institutions conducting work at the P3 
and P4 levels must have a BSO. The 
officer is required at those levels be- 
cause the sophisticated equipment and 
facilities require special abilities. The 
Laboratory Safety Monograph (p. 191- 
193) outlines the qualifications and 
role. But the Guidelines do not man- 
date such an officer for PI and P2 
work because the potential risk at 
those levels is minimal and the exper- 
tise readily available for laboratory 
safety. The Committee concurred with 
this view. 
Other commentators recommended 
that the Guidelines assign to the BSO 
responsibility for monitoring, keeping 
records, and health surveillance. The 
DHEW Committee reviewed the quali- 
fications of BSOs, noting the absence 
of certification procedures for such a 
new and ill-defined discipline. Accord- 
ingly, it was agreed that certification 
requirements should not now be stipu- 
lated for BSOs and that flexibility 
should be encouraged to permit a BSO 
to have responsibilities for such activi- 
ties as health surveillance. As noted in 
the LSM, one can call on the environ- 
mental health and safety program at 
the institution to assist in a variety of 
the duties suggested for the safety of- 
ficer. 
The BSO is responsible for develop- 
ing emergency plans, and the NIH will 
provide assistance for program devel- 
opment. But in my view, it is, far more 
sensible at present to begin emergency 
plans at a local level than to attempt 
to develop them on a grander scale 
until any hazards are better under- 
stood. Unless the principal investiga- 
tor has already done so, the BSO is 
also responsible for providing reports 
to the IBC and the institution on 
problems with and violations of the 
Guidelines and on all significant re- 
search-related accidents and illnesses. 
Principal Investigator 
As stated in the introduction to part 
IV, safety involving recombinant DNA 
molecules depends in the first instance 
on the individuals conducting the re- 
search. The Guidelines are designed to 
help the Principal Investigator deter- 
mine the safeguards that should be 
implemented, and it is his or her re- 
sponsibility to ensure that the purpose 
of the Guidelines is fulfilled. A 
number of the comments were devoted 
to the Pi’s role in laboratory safety 
and training. 
Training. Many of the correspon- 
dents and several of the witnesses at 
the September 15 hearing recommend- 
ed training programs for all laboratory 
personnel, including custodial person- 
nel, the members of the Institutional 
Biosafety Committee, the Biological 
Safety Officer, and all relevant insti- 
tutional officials. One commentator 
recommended that laboratory workers 
in P2 or higher facilities take and pass 
training courses or demonstrate equiv- 
alent competency before working di- 
rectly with organisms containing re- 
combinant DNA. Further, a central- 
ized and uniform certification process 
for workers at the P3 or P4 level was 
advocated. It was urged that the 
Guidelines not be revised until there 
are uniform procedures for training 
certification of all biosafety officers 
and all recombinant DNA laboratories 
at the P2 or higher levels. Some sug- 
gested the Biological Safety Officer 
should be responsible for the certifica- 
tion process. 
A number of commentators advised 
further that the Guidelines specify 
components of training for a program 
available to all potentially exposed 
workers. It was also recommended 
that the PI make available copies of 
approved protocols that describe po- 
tential biohazards and precautions, 
not only to the research personnel but 
also to the custodial staff. It was fur- 
ther suggested that NIH and OSHA 
should jointly sponsor technical and 
educational programs for IBC mem- 
bers and Biological Safety Officers. 
I appreciate the concern regarding 
the quality and uniformity of training. 
As I stated in my Decision document 
(July 1978), NIH is responding to this 
by placing a high priority on the de- 
velopment of training standards and 
courses. For example, we are support- 
ing, as noted previously, a working 
panel of the American Society for Mi- 
crobiology that is considering stand- 
ards for training in microbiological 
techniques for recombinant DNA re- 
search. When a report is submitted to 
NIH, it will be shared with institu- 
tions, IBCs, Pis, and BSOs. National 
certification of proficiency in any re- 
search technology is fraught with 
problems, especially in areas in which 
knowledge is increasing rapidly. 
NIH is already sponsoring and devel- 
oping courses on these standards of 
training. For example the University 
of Minnesota School of Public Health 
has developed and conducted a series 
of short courses on “Biohazard Con- 
tainment and Control for Recombin- 
ant DNA Molecules” under the spon- 
sorship of the National Cancer Insti- 
tute’s Office of Research Safety. The 
objective is to instruct laboratory 
workers on the principles of safety in 
the research laboratory and, particu- 
larly, on their application to the safe 
handling of recombinant DNA mole- 
cules. To date, six courses have been 
presented. A total of 221 participants 
from 97 institutions have attended. 
They have come from 7 government 
laboratories, 34 private or industrial 
laboratories, and 56 universities. 
The Office of Research Safety, NCI, 
is also developing a training course for 
biosafety officers on practices and pro- 
cedures for the control of biohazards 
in the research laboratory. The pur- 
pose is to equip biosafety officers with 
the basic knowledge and skills to carry 
out effectively the responsibilities 
specified in the NIH Guidelines. De- 
tailed instruction on methods for eval- 
uating, certifying, and monitoring 
physical-containment safeguards will 
be offered. Guidance will also be pro- 
vided on how to organize, plan, devel- 
op, and conduct a comprehensive bio- 
safety program. 
NIH plans to further the biosafety 
training efforts of institutions by pro- 
viding on-site consultation. The pro- 
gram will be designed to assist inslitu- 
tions and their IBCs, biosafety offi- 
cers, and laboratory workers in effec- 
tively carrying out the requirements 
of the Guidelines. Biosafety profes- 
sionals will be available to visit institu- 
tions and assist them in evaluating 
and improving their safety programs. 
These professionals will also be availa- 
ble to help solve specific problems in, 
physical containment. A principal ele- 
ment of the program will be to pro- 
mote good laboratory practice and to 
reinforce its importance. 
Training of laboratory workers is a 
continuous process required under the 
Guidelines. One commentator ex- 
pressed uncertainty as to who has the 
responsibility for seeing that person- 
nel are trained in safety practices and 
FEDERAL REGISTER, VOL 43, NO. 247— FRIDAY, DECEMBER 22, 1978 
