Federal Register / Vol. 47, No. 235 / Tuesday, December 7, 1982 / Notices 
55109 
biohazardous agents and recombinant 
DNA. In developing the course, the 
University of Minnesota cooperated 
with the Hoard of Education and 
Training of the American Society for 
Microbiology. The course is divided into 
five training units: Unit I — Host-Parasite 
Relationships; Unit II — Microbial 
Ecology; Unit III — Principles of Physical 
and Chemical Containment; Unit IV — 
Diological Containment for Recombinant 
DNA Molecules; and Unit V — 
Laboratory Skills — Including Hands-On 
Laboratory Exercises. The five units 
represent 45 hours of training, 10 of 
which are devoted to actual laboratory 
practice and are designed to be used in 
a variety of combinations to fit the 
needs of the individual institutions. The 
individual training modules include the 
following features: 
(1) A set of qualifications for the 
individual who would serve as 
instructor; 
(2) A set of learning objectives to be 
fulfilled by participants completing the 
module; 
(3) An annotated outline of the subject 
matter with slides and instructor .notes' 
keyed to the text; 
(4) A set of references to provide the 
instructor and participants with more 
detailed information; and 
(5) A set of multiple choice questions 
geared towards evaluating whether the 
objectives had been fulfilled by the 
participants. 
In total, the materials consist of over 
700 pages of written material and 500 
35mm slides. 
These training materials are intended 
to provide a minimum base of 
knowledge and skills which should be 
demonstrated by any individual who is 
going to work with potentially 
biohazardous agents or recombinant 
DNA molecules. The minimum base, as 
defined in these materials, originates 
from a project undertaken by the 
American-Society for Microbiology in 
1977-78 in response to questions about 
biological safety which arose from 
concerns about recombinant DNA 
research at that time. Every institution 
in which biohazardous agents are 
handled should be responsible for 
training all potentially affected workers 
in the principles of biological safety. The 
awareness and motivation of the 
individual worker is the most important 
ingredient in any safety program and is 
most likely to be found where the 
institution is committed to the same 
goal. 
The NIH Division of Safety is 
developing a plan for distribution of 
these materials to various institutions. 
They were previewed at the Twenty- 
Fifth Annual Diological Safety 
Conference in Boston on November 4— <>, 
1982. 
A second phase of the contract will 
consist of the production of slide/ 
cassette packages and one videotape 
with accompanying study guides. The 
objective of this phase is to translate 
selected portions of the training units 
into self-study materials. These study 
materials are currently under review 
and further development by the Division 
of Safety. 
V. CDC/NIOSH Report on Medical 
Surveillance 
At the 1980 Workshop on 
Recombinant DNA Risk Assessment it 
was recommeded that the Centers for 
Disease Contol (CDC) consider possible 
types of health surveillance for workers 
using recombinant DNA. The CDC and 
the National Institute for Occupational 
Safety and Health (NIOSH) 
subsequently have prepared a report 
entitled “Medical Surveillance of 
Biotechnology Workers: Report of the 
CDC/NIOSH Working Group on 
Medical Surveillance for Industrial 
Applications of Biotechonology." 
The preface of the report states: 
The guidelines for medical surveillance of 
biotechnology workers which are presented 
and discussed in this report are intended 
neither as binding regulations nor as uniform 
requirements which are to be applied without 
discrimination throughout every phase of the 
industries using fermentation biotechnology. 
Rather the guidelines are intended as 
suggestions for prudent medical practice. 
The potential occupational hazards which 
are associated with industrial applications of 
biotechnology will vary according to the 
microbial species, products, and reagents 
used in the various sectors of the industry. 
For those reasons, the application of these 
guidelines should in every instance be guided 
by a reasoned assessment, conducted under 
the direction of the Institutional Biosafety 
Committee (IBC), of the potential hazards 
which will be associated with each specific 
situation and process. Likewise, the 
particular components of each medical 
surveillunce program should be specifically 
tailored to address thd actual or potential 
hazards of the processes under consideration. 
The report states that establishment 
of medical surveillance for workers in 
any newly developed industry 
constitutes prudent medical practice. 
However, the report states that “the 
likelihood is small that a medical 
surveillance program for biotechnology 
workers will detect any illness caused 
by recombinant organisms or by their 
products or reagents." 
The report was reviewed by the RAC 
and its Large-Scale Review Working 
Group and has been published in the 
Nil I Recombinant DNA Technical 
Bulletin (Volume 5. page 133, September 
1982). 
IV. Implementation 
NIH will continue to monitor progress 
in the risk assessment projects cited 
above. NIH will also review ongoing 
research for data pertinent to risk 
assessment by analysis of data from 
research which is published or 
presented at meetings, and by direct 
contacts with scientists. Liaison will be 
maintained with those who have related 
responsibilities in other Federal 
agencies, in other countries, and in 
national and international scientific 
organizations. ORDA will provide 
periodic updates on risk assessment to 
the RAC and its Risk Assessment 
Subcommittee. NIH has high 
containment laboratories which can be 
made available, as necessary, for 
experiments requiring the highest level 
of physical containment. 
Dated: November 23. 1982. 
Richard M. Krause, 
Director, National Institute of Allergy and 
Infectious Diseases, National Institutes of 
Health. 
Note. — OMB's "Mandatory Information 
Requirements for Federal Assistance Program 
Announcements” (45 FR 39592) requires a 
statement concerning the official government 
programs contained in the Catalog of Federal 
Domestic Assistance. Normally NIH lists in 
its announcements the number and title of 
affected individual programs for the guidance 
of the public. Because the guidance in this 
notice covers not only virtually every Nil I 
program but also essentially every federal 
research program in which DNA recombinant 
molecule techniques could be used, it has 
been determined to be not cost effective or in 
the public interest to attempt to list these 
programs. Such a list would likely require 
several additional pages. In addition. NIH 
could not be certain that every federal 
program would be included as many federal 
agencies, as well as private organizations, 
both national and international, have elected 
to follow the NIH Guidelines. In lieu of the 
individual program listing, NIH invites 
readers to direct questions to the information 
address above about whether individual 
programs listed in the Catalog of Federal 
Domestic Assistance are affected. 
(NIH programs are not covered by OMB 
Circular A-95 because they fit the description 
of "programs not considered appropriate" in 
Section 8(b) (4) and (5) of that Circular) 
(FR Doc 82-33002 Filed 12-8-82 8.45 am| 
BILLING CODE 4140-01-M 
