45652 
Federal Register / Vol. 51, No. 244 / Friday. December 19. 1986 / Notices 
fermentation has a long and 
distinguished history and currently 
accounts for products valued at more 
than $2 billion annually (attachment 
Tables 1-7). All but a minuscule 
proportion of this production employs 
non-pathogenic organisms and is carried 
out safely under conditions significantly 
less restrictive than the N1H Guidelines' 
BLl-LS, which requires that 
recombinant organisms be handled in a 
closed system, that culture fluids 
containing viable organisms not be 
removed from a closed system, that 
exhaust gases removed from a closed 
system be treated by Alters equivalent 
to HEPA Alters, etc. 
To ensure compliance with the NIH 
Guidelines, the £. coJi and 
Saccharomyces cerevisiae production 
organisms used to manufacture the Ave 
DNA-derived pharmaceuticals approved 
by FDA (human insulin, human growth 
hormone, two alpha-interferons, and 
hepatitis B vaccine), are indeed grown 
under containment conditions at least 
BLl-LS. This degree of containment is 
expensive, unwieldy and unnecessary. 
Despite the interpretation discussed 
above of the language in the )une 28 
document. FDA has received numerous 
inquiries and requests from academics, 
industrial representatives, and others 
who have found the language in the June 
28 document and the NIH Guidelines not 
explicit enough for purposes of strategic 
planning. Therefore, we propose the 
following amendment to the NIH 
Guidelines: 
In Appendices C-Il. C-IU. and C-IV, 
delete the followinng language: 
For these exempt laboratory experiments. 
BLl physical containment conditions are 
recommended. 
For large-scale (LS) fermentation 
experiments BLl-LS physical containment 
conditions are recommended. However, 
following review by the 1BC of appropriate 
data for a particular host-vector system, some 
latitude in the application of BLl-LS 
requirements as outlined in Appendix K-D-A 
through K-tl-F is permitted. 
And substitute: 
For these exempt laboratory experiments, 
the appropriate physical containment 
conditions need be no greater than those for 
the host organism unmodified by 
recombinant DNA techniques. 
For large-scale (LS) fermentation 
experiments, the appropriate physical 
containment conditions need be no greater 
than those for the host organism unmodified 
by recombinant DNA techniques. 
Thank you. We hope that this 
proposal will receive consideration by 
the RAC at the earliest opportunity. 
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 NIH 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. 
Dated: December 11, 1988. 
Bernard Talbot, 
Acting Director. National Institute of Allergy 
and Infectious Diseases. 
(FR Doc. 88-28442 Field 12-18-88; 8:45 am] 
SI LUNG CODE 4140-01-41 
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