Recombinant DNA Advisory Committee - 10/16/90 
Dr. Riley said the subcommittee on Revision of the NIH Guidelines 
had considered a proposal to revise Appendix K and that this 
proposal, with certain modifications, would be presented to the 
RAC. She noted that the proposal could be found beginning on 
page 37846 of The Federal Register dated September 13, 1990. She 
said the subcommittee recommended acceptance of these revisions 
to Appendix K with the following changes: 
1. The acronym "GILSP," which stands for "Good Industrial 
Large-Scale Practices," should be changed to "GLSP" to 
indicate "Good Large-Scale Practices" since this 
Appendix is not limited to industry specifically, but 
to all large-scale facilities; 
2. Strike the word "industrial" under Appendix K-I, 
"Selection of Physical Containment Levels," lines 18 
and 24 of the first paragraph on page 37847, since the 
appendix will apply to all large-scale facilities; 
3. Under Appendix K-II-A, strike the final sentence, 
"Processes and equipment should be designed and 
constructed to assure integrity of the production 
organism and resulting product," since this does not 
require explicit expression; 
4. Under Appendix K-II-F, add the word "governmental" 
after the word "applicable" to make the sentence read, 
"Discharges containing viable recombinant organisms 
shall be handled in accordance with applicable 
governmental environmental regulations;" 
Dr. Riley said that in light of these recommended modifications 
the subcommittee has asked that ORDA review both the descriptive 
and tabular material describing the GLSP level to ensure they 
meet with the levels of containment called for by all four levels 
in the existing National Institutes of Health (NIH) Guidelines 
for Research Involving Recombinant DNA Molecules as modified. 
ORDA was also asked to review the footnotes to ensure they meet 
all modified NIH Guidelines and the intent of Appendix K. 
Dr. Riley said the subcommittee recommended that the definition 
of "Good Industrial Large-Scale Practice (GILSP) Organism," as 
found in Appendix K - Definitions to Accompany Containment Grid 
and Proposed Modification to Appendix K," be deleted as it is 
redundant with a definition found earlier in the text. 
Dr. Bourquin questioned whether a statement should be added in 
the form of a footnote that, "This summary table represents NIH 
Guidelines only. Other regulations or guidelines may apply and 
are not necessarily superseded by the recommendations of this 
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Recombinant DNA Research, Volume 14 
