Federal Register / Vol. 46, No. 233 / Friday, December 4, 1981 / Notices 
59395 
action in the Federal Register. The RAC 
may wish to modify the proposal before 
its formal publication in the Federal 
Register for public comment. 
Dr. Gottesman noted that the 
background document discusses basic 
assumptions. It is difficult to imagine 
hazards resulting from random 
combinations of DNA. Furthermore, 
deliberate combinations will not be 
harmful in most cases. However, there 
are still some questions about certain 
experiments. The issue is how to deal 
with the latter experiments. The 
proposal of the Working Group would 
retain IBC prereview so that there is a 
level of review beyond the investigator. 
Dr. Gottesman then reviewed the 
main points of the Working Group 
proposal. The proposed containment 
levels are very similar to those of the 
Baltimore-Gampbell proposal, i.e., 
containment would be largely based on 
the pathogenicity of the host. For all 
non-exempt experiments, at least the PI 
level would be recommended. The 
Working Group proposal eliminates 
reference to biological containment in 
Part III of the Guidelines. The Working 
Group proposal also adds in admonition 
which reads as follows; 
If there is clear evidence that the donor DNA 
will significantly change the pathogenicity of 
the host, the containment level appropriate to 
the anticipated change will be applied. 
While the Baltimore-Gampbell 
proposal would be a voluntary code of 
practice, the Working Group proposal 
retains IBC prereview of covered 
experiments and retains Section IV-G of 
the Guidelines which discusses possible 
penalties for failing to follow the 
Guidelines. However, the Working 
Group recommends eliminating 
membership requirements for IBCs 
currently specified in Section IV-D of 
the Guidelines. While the Baltimore- 
Gampbell proposal retains the 
prohibition section of the Guidelines (I- 
D), the Working Group proposal 
eliminates the prohibitions on the basis 
that currently prohibited experiments 
would be prereviewed by an IBC in their 
proposal. Dr. Gottesman said that she 
felt that the major issues for discussion 
are: prohibitions, prereview of covered 
experiments, and containment levels. 
Dr. Bems noted that five Working 
Group members, including himself, 
submitted a minority report which 
disagrees with the Working Group’s 
proposal to retain the mandatory nature 
of the Guidelines. The minority report 
recommends elimination of Part IV of 
the Guidelines. 
Dr. Goldstein said that he agrees with 
parts of the Working Group report. He 
said that IBCs are still needed although 
a survey in California has indicated 
great variation in IBCs. He also said that 
prohibited experiments need to be more 
clearly considered. 
Dr. Harris said that she felt that the 
Working Group’s report is an acceptable 
compromise. 
Ms. King said that the report suggests 
a direction for movement but that 
details need to be worked out. She said 
that if there are Guidelines, there should 
be sanctions. She said that 
distinguishing NIH grantees from non- 
grantees is not unique; she cited the 
situation with human experimentation. 
Ms. King said that she strongly favors 
retention of the sanctions. 
Dr. Nightingale said that she supports 
the recommendations of the Working 
Group, saying that they represent a good 
compromise. She expressed concern 
about the availability of other guidelines 
cited in Working Group report. In this 
regard, she noted the many comments 
received on the proposed CDC Biosafety 
Guidelines for Microbiological and 
Biomedical Laboratories. She also 
expressed concern that prohibition I-D- 
4, dealing with deliberate release into 
the environment, had not been dealt 
with. Dr. Nightingale said there is a 
necessity for accountability when public 
funds are being used. She said the RAC 
needs an assessment of outside 
perceptions and that the backgroimd 
document needs further work. 
Dr. Zinder then addressed the RAC. 
He noted that he had prepared the 
minority reports to the Working Group’s 
recommendations. He said that although 
there is a disagreement about the 
administrative aspects of the 
Guidelines, there was unanimity in the 
Working Group in favor of the new 
proposed containment levels. He noted 
that although inclusion of a slightly 
modified Part IV was recommended by 
the Working Group, five members have 
now endorsed a minority report stating 
that Part IV should be removed from the 
Guidelines. Drs. Adelberg and Zinder 
also signed a second minority report 
recommending complete elimination of 
the Guidelines. Dr. Zinder said that he 
and the scientists concerned about 
recombinant DNA originally proposed 
guidelines which would give guidance 
and not be enforced, rather than rules. 
He cited some of the history leading to 
the issuance of mandatory guidelines in 
1976. Dr. Zinder said that if Part FV is 
retained in the revised Guidelines, there 
should be a strong justihcation for 
retaining it stated in a position paper. 
He said that he prefers that the 
Guidelines be rescinded and replaced 
with a simple recommendation. He said 
that if scientists are to be encouraged to 
speak up in the future about conjectural 
risks, they must be shown that when 
interim regulation is subsequently 
shown to be superfluous, it can be 
removed. 1 
Dr. Baltimore said the Baltimore- 
Gampbell proposal was a compromise 
between scientific judgment that there is 
no justification for Guidelines being 
other than a code of accepted practice, 
and the necessity for considering 
political and social factors. Their 
proposal retained the prohibitions, 
which he said are one of the most noted 
parts of the Guidelines. It has been 
argued that the RAC should not consider 
political and social factors; however. Dr. 
Baltimore did not agree. He said that the 
prohibitions have less and less 
justification and that he Bnds no | 
difficulty in accepting the Working 
Group’s recommendation regarding 
elimination of prohibited experiments, 
except for elimination of the prohibition : 
against acquisition of a drug resistance 
trait in those cases in which such (i 
acquisition could compromise the use of i 
a dnig to control disease agents in | p 
human or veterinary medicine or fa 
agriculture. Concerned scientists 
originally proposed guidelines meaning li 
only guidance and not regulations; the . i|j 
RAC will have to decide the future , pj 
course of the Guidelines. He noted that , f 
there apparently already is general ^ 
agreement in the RAC on modifying Part 
III dealing with containment levels and 
agreement on retaining the exemptions. 
The issue is Part FV of the Guidelines. 
He said that he feels that it is 
anomalous to retain the current 
procedures section of the Guidelines. 
However, political and social issues j 
need to be considered. If the Federal 1 
government pulled completely out of the 
issue, local governments might well 
overreact. T^e Federal government 
needs to provide surveillance, a forum 
for considering questions, and an office 
where inquiries can be authoritatively ^ 
answered. Therefore, maintenance of m 
the RAC, ORDA, and abbreviated 
guidelines are necessary Dr. Baltimore ^ iP 
expressed support for the original Jh 
Baltimore-Campbell proposal, with some j| 
modifications based on the Working 9 
Group recommendations. Dr. Zinder , S 
said that if Guidelines are to be / 
retained, it is for political and social ^ 
reasons. However, the political climate 
has changed. In New York State, which 
previously passed a law regulating ' 
recombinant DNA research, a bill has ^ 
been introduced to repeal the law based 
on the assertion that the medical ,, 
institutions which perform such research, 
in New York State have proven to be ) 
trustworthy. ; 
[284] 
