Biomedical Engineering Reference
In-Depth Information
organisms containing recombinant DNA molecules. It shall apply to large-
scale research or production activities as specified in Section III-D-6,
Experiments Involving More than 10 Liters of Culture
. It is important to note
that this appendix addresses only the biological hazard associated with
organisms containing recombinant DNA. Other hazards accompanying the
large-scale cultivation of such organisms (e.g., toxic properties of products;
physical, mechanical, and chemical aspects of downstream processing) are
not addressed and shall be considered separately, albeit in conjunction with
this appendix.
All provisions shall apply to large-scale research or production activities
with the following modifications: (i) Appendix K shall supersede Appendix
G,
Physical Containment
, when quantities in excess of 10 liters of culture are
involved in research or production. Appendix K-II applies to Good Large-
Scale Practice; (ii) the institution shall appoint a Biological Safety Officer
if it engages in large-scale research or production activities involving via-
ble organisms containing recombinant DNA molecules. The duties of the
Biological Safety Officer shall include those specified in Section IV-B-3,
Biological Safety Officer;
; (iii) the institution shall establish and maintain a
health surveillance program for personnel engaged in large-scale research
or production activities involving viable organisms containing recombi-
nant DNA molecules which require Biosafety Level (BL) 3 containment at
the laboratory scale. The program shall include: preassignment and periodic
physical and medical examinations; collection, maintenance, and analysis
of serum specimens for monitoring serologic changes that may result from
the employee's work experience; and provisions for the investigation of any
serious, unusual, or extended illnesses of employees to determine possible
occupational origin.
Appendix K-I: Selection of Physical Containment Levels
The selection of the physical containment level required for recombinant
DNA research or production involving more than 10 liters of culture is
based on the containment guidelines established in Section III,
Experiments
Covered by the NIH Guidelines
. For purposes of large-scale research or pro-
duction, four physical containment levels are established. The four levels
set containment conditions at those appropriate for the degree of hazard
to health or the environment posed by the organism, judged by experience
with similar organisms unmodified by recombinant DNA techniques and
consistent with Good Large-Scale Practice. The four biosafety levels of large-
scale physical containment are referred to as Good Large-Scale Practice,
BL1-Large Scale, BL2-Large Scale, and BL3-Large Scale. Good Large-Scale
Practice is recommended for large-scale research or production involving
