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Federal Register / Vol. 45, No. 20 / Tuesday, January 29, 1980 / Notices 
These commentators included four 
RAC members, and six former RAC 
members. Comments included the 
following — "Section III— O describing 
experiments with E. coli K-12 host- 
vector systems represents a realistic and 
safe modification of some of the 
previous regulations. . . . We wish to 
express our confidence in the good 
judgment and scientific qualifications of 
the committee that has made thSse 
decisions. The enormous effort in 
preparing these guidelines in the interest 
of all of us should earn high praise.” — 
“In Section III— O there is a classificatory 
downgrading of a large group of 
experiments in E. coli K-12. 1 applaud 
that change. It appears to me to be 
soundly based on the accumulating 
experience and evaluation of real 
hazards of such experiments.” — “For 
this reason, I strongly endorse the 
decentralization of control over 
experiments using the E. coli K-12 Host- 
Vector systems as outlined in section 
III-O." — “I, therefore, urge adoption of 
Section III-O, as a way of eliminating a 
costly and time-consuming unnecessary 
obstacle to research of great practical 
importance as well as scientific 
interest.” — “In particular, I specifically 
endorse the revision of the guidelines 
concerning the K-12 containment 
(section III-O). The proposals are a 
reasonable way of matching the realistic 
risks with the clear benefit of removing 
unnecessary administrative work.” — “I 
believe that the category change is fully 
consistent with public safety, and is 
essential to permit legitimate health 
related research dependent upon cloning 
techniques to proceed.” — “I consider the 
evidence overwhelming that these 
experiments pose no significant hazard.” 
III-B-2-b. Request that Experiments 
Involving E. coli K-12 Be Exempted 
from the Guidelines 
Nine commentators, while indicating 
their endorsement of Section III-O, also 
indicated that they favored a somewhat 
greater relaxation of the Guidelines. 
Comments included the following — "My 
personal opinion is that the data does 
not even warrant registration of these 
experiments.” — “My current view is that 
even Pi containment is probably 
unnecessary." 
Nineteen commentators wrote 
requesting that all or most experiments 
with E. coli K-12 be completely 
exempted from the Guidelines; this 
would relax the conditions for doing 
these experiments much further than I 
had proposed in Section III-O of the 
proposed revised Guidelines. (Some of 
these commentators endorsed Section 
III-O as a “step in the right direction.”) 
Comments included the following — "To 
continue Federal regulation after 
evidence has been obtained that there is 
no clear threat to the public health is a 
waste of already dwindling Federal 
scientific resources and in addition, sets 
an ominous precedent for future Federal 
regulatory adventures. In addition, at 
the level of the working scientist or 
student, the perpetration of needless 
regulations, directed at imagined 
hazards, undercuts our continuing 
efforts to institute and make effective 
safety practices governing the handling 
of real pathogens and toxic agents." 
On the other hand, four commentators 
specifically endorsed the decision that 
experiments with E. coli K-12 not be 
exempted from the Guidelines, and four 
commentators specifically endorsed IBC 
registration of these experiments. 
In my Decision Document/ 
Environmental Impact Assessment of 
November 30, 1979, 1 discussed why I 
was not proposing to exempt from the 
Guidelines experiments under the “E. 
coli K-12/P1 Recommendation.” As I 
wrote then, and still believe is prudent 
policy: "Three important safety features 
for these experiments that will not be 
exempt, but will according to the 
proposed decision form a special class 
under the Guidelines, are: 
“1. Pi. Containment — Including the 
ban on mouth pipetting and the 
requirement that all biological wastes 
shall be decontaminated. Proper 
employment of Pi conditions eliminates 
the primary means of E. coli escape 
from the laboratory. 
“2. EKl — Allowing only E. coli K-12 
strains and not allowing the use of 
conjugation proficient plasmids or 
generalize transducing phages. This 
greatly reduces the probability that any 
escaping E. coli K-12 would survive and 
transfer their recortibinant DNA to other 
organisms. 
“3. IBC Oversight — Continuing local 
surveillance and registration of these 
experiments. 
"In addition, keeping these 
experiments under the Guidelines rather 
than exempting them means that any 
scale-up of the experiments beyond 10 
liters will require prior NIH approval.” 
These important safety features apply 
to the experiments described in Section 
III-O of the proposed revised 
Guidelines; they would not apply if 
these experiments were exempted from 
the Guidelines. 
III-B-2-c. Request That Section III-O of 
the Guidelines Not Be Promulgated 
Of the 185 letters received by January 
18, 1980, five said that Section III-O 
and/or the proposed revised Guidelines 
should not be promulgated. These five 
commentators included one current and 
one former RAC member. Among the 
comments they made were: 
1. "I urge you to extend the comment 
period." 
2. The NIH Director should reconsider 
"the E. coli exemption as voted for by 
the RAC at its September 1979 meeting." 
3. "It needs emphasis that there is 
currently no requirement (only a 
recommendation) that institutions 
require workers in this field to be 
trained in good laboratory practice.” 
4. Many of the arguments used to 
justify this revision of the Guidelines 
were used to justify a previous revision. 
5. The discussion in the November 30 
Decision Document “implies that 
microorganisms do not ‘escape' from 
laboratories in which containment is 
supposed to be practiced." 
6. “I continue to be disturbed that 
such far-reaching policy changes are 
being considered in the absence of data 
from a risk-assessment program." 
7. "I’m less than totally convinced by 
the information in the November 30, 
1979 Federal Register that it is prudent 
to allow cloning of all DNA at the PI + 
EKl level except where-prohibited.” 
None of these commentators provided 
any new scientific data. 
In reply to the first comment given 
above, I note that although the comment 
period formally ended December 30, 
1979, 1 considered all letters received* 
until January 18, 1980. 
In response to the second comment 
given above, I note that the November 
30 Decision Document/Environmental 
Impact Assessment discussed in detail 
why I am not in fact exempting these 
experiments from the Guidelines. 
In response to the third comment 
given above, the NIH Guidelines do in 
fact require training of workers. Section 
IV-D-l-g of the Guidelines discussing 
responsibilities of the Institution says 
the Institution shall “Ensure appropriate 
training for the IBC chairperson and 
members, the BSO, Principal 
Investigators (Pis), and laboratory staff 
regarding the Guidelines, their 
implementation, and laboratory safety. 
Responsibility for training IBC members 
may be carried out through the IBC 
chairperson. Responsibility for training 
laboratory staff may be carried out 
through the PI. The Institution is 
responsible for seeing that the PI has 
sufficient training, but may delegate this 
responsibility to the IBC.” Section IV-D- 
3-a-2 says the InstitutionarBiosafety 
Committee is responsible for “An 
assessment of the facilities, procedures, 
and practices, and of the training and 
expertise of recombinant DNA 
personnel.” Section IV-D-5-d-2 of the 
Guidelines says the Principal 
Investigator is responsible for 
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