4B34d 
Federal Register /• VoL 50. No. 226 / Friday, November 22; 19B5 / Notices 
The RAC discussed this proposal at 
the September 23, 1985, meeting: 
The RAC considered the minutes of 
the August 16. 1935. meeting of the 
Working Group un Toxins and the 
advice of two ad hoc consultants. Dr. 
|ohn Collier of Harvard Medical School 
and Dr. Thomas Waldmunn of the 
National Cancer Institute. By a vote of 
twelve in favor^noneopposed„and four 
abstentions, the RAC recommended the 
experiments be permitted-at BL2 
containment plus. BL3 practices with the 
use of poorly mobiliaabie plasmid- 
vectors sueb-as EK2 certified plasmids. F 
accept this recahxiiefulatton.and 
appropriate Language has bees added- to 
Appendix F of the NIH Guidelines. 
C. Proposed Amendments of Appendix 
C-Ill of the- NfH> Guide lines 
BioTechniea International. Inm, of 
Cambridge.N4assachtt8e«8,.{a.a letter of 
August 13. 1985. proposed the following 
amendments to Appendix OIlLof the 
NIH Guidelines. The first paragraph of 
Appendix C-Ifl wouftf be amended to 
read as follows: 
“Experiments, which, use 
Saccharomyces cerevisiae hostrvector 
systems, with the exception of 
experiments listed below. are exempt 
from these Guidelines." - 
This amendment would-extend the 
current exemption- to include strains 
other than "laboratory strains.” - 
A new second paragraph would be 
added to Appendix C— III to read as 
follows: 
"Experiments whieh use 
Saccharomyces uvarum host-vector 
systems, with the exception of 
experiments listed below, are exempt 
from these Guidelines.’” 
This proposal was published in the 
August 19, 1985,. Federal Register lor 
public comment. No comments were 
received during tha comment period. 
The RAC considered this proposal at 
the September 23, 1985, meeting. It was 
noted that no industrial or wild & 
cerevisiae strains are known to be 
pathogenic to either man or animals. In 
fact, products. containing S. cerevisiae. 
including beer, wine, brewer’s yeast, 
tablets, bread.andyeast extract flavor 
enhancers, have been consumed by- 
humans for thousands of years. Brewer’s 
and distiller's yeasts are also consumed, 
by the ton by domestie-livestock. 
Laboratory and non-laboratory strains 
are virtually identical with respect to 
their morphology, biochemistry, and- 
growth habits. The arrangement'of the 
genomes (Le„ the genetic mupsfof the 
two classes are largely 
indistinguishable. These similarities are 
not surprising given that all laboratory 
strains were ultimately derived from 
wild and industrial yeasts. 
Most brewing strains sporulate 
poorly, and the few spores that can be 
obtained have extremely poor viability. 
Thus, industrial strains tend to be much 
less capable of mating than laboratory 
strains, many of which have been bred 
and selected for increased ability to 
mate, sporulate and germinate. These 
factors together lead to a considerable 
phenotypic stability for most industrial 
strains that, in fact, make them 
desirable hosts for recombinant DNA 
experiments. 
Evidence was presented on the great 
similarity between cerevisiae and S. 
uvarum. 
The RAC accepted these arguments 
and by vote of seventeen in favor, none 
opposed and no abstentions, 
recommended approvafof The proposal 
as it appeared in the August 19, 1985* 
Federal Register. 
I accept this recommendation- and- 
Appendix C-TIl has been modified. 
D. Proposed Amendment' of Part III of 
the NIH Guidelines 
In a memorandum, dated February 12. 
1985, Dr. Bernard Talbot,. Deputy 
Director of the National Institute of 
Allergy and Infectious Diseases, noted 
that under the NIH-Guidelines for 
Research Involving Recombinant DNA 
Molecules certain proposals-are 
receivedby NIH for review by the NIH 
Recombinant DNA Advisory Committee 
(RAC) and subsequent NIH approval. 
Recently other Federal agencies have 
made steps toward assuming new- roles 
in review of recombinant DNA 
proposals. Because of these 
developments, . it couldnow happen that 
a proposal submitted to the NIH for 
RAC review and NIH approval may be 
also submitted to another Federal 
agency for review. 
Dr. Talbot stated: 
"In such a case, I believe it would be 
advantageous-for NIH to have the option 
of deferring to the review and approval 
by the other Federal agency rather than 
always going through review and 
approval by both the other Federal 
agency and the NIH. In order to allow 
this, I request that the following 
proposed change in- the NIH Guidelines 
be issued- for public comment, and 
placed on the agenda, of the next RAG- 
meeting. I propose that a new sentence 
be added at the end of Section. Ill-A of 
the Guidelines ('Experiments that 
Require RAC Review and NIH; and IBC 
Approval- Before Initiation ) just before 
Section III— A— 1 of the Guidelines, as 
follows: ’If experiments in this category 
are submitted for review to another 
Federal agency,, the submitter shall- 
notify ORDA;.ORDA may then 
determine that such review serves the 
same purpose, and. based on that 
determination. notify the submitter that 
no RAC review will tahe place, no NIH 
approval iff necessary, and the 
experiment may proceed upon approval 
from the otherFederal Agency.' " 
The proposal waa published- in the 
March 2a 1985. Fedesat Register (50 FR 
12456) for comment. 
One comment was received on the 
proposalt Dr. Carol Lax Gronbeck of 
Genentech, Die., of South San Prancisco, 
California, wrote: 
"At the present 1 time: the Office of 
Recombinant DNA Activities andthe 
NIH Recombinant DNA Advisory 
Committee represent the only formal 
government body with the expertise and' 
large base of experience to evaluate 
research proposals. Genentech agrees 
that dual review of proposals would 
seem unnecessary; however, concern 
also exists thatatthis time, various 
Federal agencies presented' with RDNA 
proposals may not have alT of the 
necessary expertise andperftnent 
experience fn-house ta thoroughly 
review the proposals. Since the function 
of such review includes determination 
that the experiment will notadversely 
affect man and/or the environment. it is 
especially important that the 
appropriate experts evaluate the 
information. To receive proper 
evaluation.and until such time that 
Federal agencies have in. place, a bio- 
technology review policy such as. that 
proposed by the Office of Science and 
Technology Policy. Genentech suggests 
a revision of Dr. Talbot’s amendment to 
read as follows: 
'If experimenta in this-category are 
submitted for review to another Federal, 
agency, the submitter shall notify QRDA 
and may provide information regarding 
the necessity of dual review; ORDA may 
then determine if dual review is 
necessary based upon whether ornot 
the reviews serve the same purpose and 
whether the other Federal agency has 
the appropriate expertise and; 
experience to thoroughly review the 
proposals in a timely manner, and* . 
"Genentech believes that; RAC should 
enjoy the privilege of exercising- am 
option to-deferrevdewi anditr is our 
belief’ that this revisiondo the 
amendment still permits RAC the 
desired option, while continuing to 
provide constructive’ advice to these 
conducting research and protection. of 
the public and environment,” 
The proposal was first considered by 
the RAC at the May 3;.1085, meeting. Ah 
that meeting, RAC voted to -table the 
proposal by a- vote of seventeen- indavor, 
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