Federal Register / Vol. 53. No. 74 / Monday, April 18, 1988 / Notices 
12753 
working group voted seven in favor, 
none opposed, and no abstentions that 
the following proposed revision of the 
last paragraph of Section 1-C be 
published for comment: 
"The NIH Guidelines are also 
applicable: (1) To projects done abroad 
if they are supported by NIH funds or (2) 
to research done abroad if it involves 
deliberate release into the environment 
or testing in humans of materials 
containing recombinant DNA developed 
with NIH funds and the research is a 
direct extension of the development 
process. If the host country, however, 
has established rules for the conduct of 
recombinant DNA projects then a 
written assurance of compliance with 
those rules may be submitted to NIH in 
lieu of compliance with the NIH 
Guidelines. Alternatively, if the host 
country does not have such rules, 
written acceptance by an appropriate 
government office of the host country is 
necessary in lieu of compliance with the 
NIH Guidelines. The NIH reserves the 
right to withhold funding if the safety 
practices to be employed abroad are not 
reasonably consistent with the NIH 
Guidelines." 
II. Large-Scale Production Involving 
Cephalosporium Acremonium Strain 
LU4-79-6 
In a letter dated December 4. 1987, Dr. 
Mark A. Fogelsong of Eli Lilly and 
Company, Indianapolis, Indiana, 
requests approval to conduct large-scale 
experiments and production involving 
Cephalosporium acremonium strain 
LU4-79-6 under less than Biosafety 
Level 1 — Large Scale [BLl-LS] 
conditions. Information on C. 
acremonium and construction of strain 
LU4-79-6 are provided in the 
submission. 
III. Proposed Amendment of Section III— 
B-5 
In a letter dated March 24, 1988. Dr. 
Joseph R. Fordham of Novo 
Laboratories. Inc.. Danbury, 
Connecticut, requests that Section III-B— 
5, Experiments Involving More Than 10 
Liters of Culture, be amended by adding 
the following paragraph: 
"For large-scale (LS) fermentation 
experiments, involving non-pathogenic 
and non-toxicogenic recombinant 
strains of host organisms having an 
extended history of safe industrial use 
the appropriate physical containment 
conditions need be no greater than those 
for the host organism unmodified by 
recombinant DNA techniques; the IBC 
can specify higher containment if it 
deems it necessary." 
Justification for the proposed change 
is included in the submission. 
IV. Proposed Amendment of NIH 
Guidelines Regarding Transgenic 
Animals 
The RAC was asked by the NIH 
Institutional Biosafety Committee to 
consider guidelines for experiments 
involving transgenic animals that do not 
technically fall under the NIH 
Guidelines because the DNA introduced 
into the animal is not “recombinant 
DNA" as defined by the Guidelines. The 
issue is whether these types of animals 
should be covered by the NIH 
Guidelines for Research Involving 
Recombinant DNA Molecules or other 
guidelines. 
The Working Group on Transgenic 
Animals met at NIH on March 28, 1988. 
and recommneded a series of 
amendments to the NIH Guidelines. 
Background. On June 26, 1986. the U.S. 
Department of Agriculture (USDA) 
issued an "Advanced Notice of 
Proposed USDA Guidelines for 
Biotechnology Research (51 FR 23367). A 
notice in the December 9, 1986, Federal 
Register (51 FR 44397) stated that USDA 
would be proposing new provisions 
relating to agricultural research for 
inclusion in the NIH Guidelines in lieu of 
the Advanced Notice of Proposed USDA 
Guidelines for Biotechnology Research 
published on June 26, 1986. USDA 
organized a workshop in Arlington. 
Virginia, on December 13-15. 1986, in 
part to develop proposed guidelines for 
plants and animals. Proposed changes to 
the NIH Guidelines developed by USDA 
were reviewed and revised by an NIH 
RAC Working Group on Revision of the 
Guidelines which met on June 22 and 
July 16. 1987. 
In this proposal, language was 
developed to modify Sections II and III 
of the NIH Guidelines to refer 
specifically to containment for research 
with whole plants and animals. 
Containment is described in the 
proposed amendments Appendix P for 
plants and Appendix Q for animals. The 
suggested modifications and additions 
will provide guidance to the Institutional 
Biosafety Committees (IBCs) and 
Principal Investigators (Pis) to assure 
safe conduct of such experiments. 
The proposed changes were published 
in the Federal Register of August 11, 
1987 (52 FR 29800), for public comment. 
The proposed modifications were 
discussed extensively by the RAC at its 
September 21. 1987, meeting. During the 
discussion, the RAC recommended a 
number of changes in the language as 
published for comment. The NIH is in 
the process of promulgating these 
proposed changes. Paragraph numbers 
cited below refer to the paragraphs as 
numbered in the August 11, 1987. 
Federal Register announcement (52 FR 
29800). 
A. On September 21. 1987, the RAC 
recommended that paragraph 7 as 
published for comment in the Federal 
Register of August 11. 1987. be 
incorporated into Section II of the NIH 
Guidelines as follows: 
"Biosafety Level 1 for animals (BLl-N) 
describes containment which is used for 
animals in which the germ line has been 
modified through recombinant DNA 
techniques (transgenic animals) and is 
designed to eliminate the possibility of 
sexual transmission of the modified 
genome or transmission of recombinant- 
DNA-derived viruses known to be 
transmitted only vertically (i.e.. 
transmitted from animal parent to 
offspring only by sexual reproduction). 
Procedures, practices, and facilities 
follow classical methods of avoiding 
genetic exchange between animals." 
The Working Group on Transgenic 
Animals on March 28, 1988. 
recommended that "(transgenic 
animals)" be deleted from this 
paragraph. 
B. The Working Group on Transgenic 
Animals on March 28, 1988, 
recommended that the following new 
sentence be added at the beginning of 
Section III— B— 3 before the paragraph 
entitled "Caution": 
"Experiments involving the 
introduction of eukaryotic viral genomes 
into the germ line of animals are 
covered in Section III— B — 4.” 
C. On September 21. 1987. the RAC 
recommended that the title of Section 
I1I-B-4 as published for comment in 
paragraph 32 in the Federal Register of 
August 11, 1987, be changed to read as 
follow's: 
"Recombinant DNA Experiments 
Involving Whole Animals." 
The Working Group on Transgenic 
Animals on March 28. 1988. 
recommended that the title of Section 
III— B — 4 be amended to read as follows: 
"Experiments Involving Whole 
Animals, Including Transgenic 
Animals." 
D. On September 21. 1987. the RAC 
recommended that paragraph 34 as 
published for comment in the Federal 
Register of August 11. 1987, be 
incorporated into Section III— B — 4 of the 
NIH Guidelines as follows: 
"This section covers experiments 
involving whole animals, both those in 
which the animal's genome has been 
altered by recombinant DNA techniques 
and experiments involving viable 
recombinant-DNA-modified 
microorganisms tested on whole 
animals. For the latter, other than 
viruses which are only vertically 
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