Federal Register / Vol. 47, No. 167 / Friday, August 27, 1982 / Notices 
38045 
suggested should be deleted but which 
NIH staff did not remove from the 
proposed revised Guidelines were cited 
in Section D of the Federal Register of 
May 26, 1982. At the RAC meeting, 
although specifically brought up. there 
was no motion to delete the above 
referenced material. Accordingly, these 
sections have been incorporated into the 
revised Guidelines. 
Other than the changes discussed 
above, the RAC recommended adoption 
of Part IV of the proposed revised 
Guidelines as published in the Federal 
Register of May 26. 1982 (47 FR 23110). I 
accept this recommendation. 
D. Parts V and VI 
The RAC recommended no changes in 
Parts V and VI as proposed in the 
Federal Register of May- 26, 1982 (47 FR 
23110). I accept this recommendation. 
E. Appendix A 
Th^ RAC recommended no changes in 
Appendix A as proposed in the Federal 
Renter of May 26. 1982 (47 FR 23110). I 
accept this recommendation. 
F. Appendix B 
The working group had discussed 
which document should be utilized to 
determine the pathogenic classification 
of an organism. As noted earlier in this 
announcement, the original 1976 
Guidelines used the publication 
Classification ofEtioIogic Agents on the 
Basis of Hazard, 4th Edition, July 1974; 
U.S. Department of Health, Education 
and Welfare, Public Health Service, 
Center for Disease Control, as the 
reference source for classification of 
microorganisms for the purposes of the 
Guidelines. All subsequent revisions of 
the Guidelines have also used this 
document. At the present time, the 
Centers for Disease Control (CDC) and 
the NIH are revising the Classification 
ofEtioIogic Agents on the Basis of 
Hazard. The working group felt, 
however, that this revised version might 
not serve the purposes of the Guidelines 
as wejl^s the original 1974 version. 
Nonetheless, the working group noted 
additional pathogens should be 
/ added to the classification in the 
Guidelines and that the classification 
should be updated regularly. It was also 
noted that some organisms might better 
be treated in a manner speciHc for the 
purposes of the Guidelines. The working 
group recommended, therefore that the 
RAC and NIH adopt for the Guidelines a 
revised version of the 1974 CDC 
classification, and that the RAC assume 
responsibility for regularly updating the 
listing. 
I accept the recommendation that the 
RAC assume responsibility to update 
periodically a revised classification of 
microoganisms for the purposes of the 
NIH Guidelines for Research Involving 
Recombinant DNA Molecules. I have 
asked ORDA to designate a working 
group on classification of 
microorganisms to make its Hrst report 
to the full committee at its next meeting. 
The proposed revised classiBcation 
developed by the working group on 
revisions was published in Appendix B 
of the proposed revised Guidelines in 
the Federal Register of May 26, 1982 (47 
FR 23110). 
The proposed revised classification 
was the only proposal of the working 
group which received a letter of 
comment. Dr. John Richardson, Director, 
Office of Biosafety, Centers for Disease 
Control (CDC) offered the following 
comments which were distributed to the 
RAC: 
A. mallei is now Pseudomonas mallei 
Diplococcus pneumoniae is now 
Streptococcus pneumoniae 
Herellea vaginicola is now Acinetobacter 
calcoaceticus 
Legionella pneumophila should be added to 
the list of Class 2 bacteria 
Mima polymorpha — delete — same as A. 
calcoaceticus 
Vibrio comma is now Vibrio cholerae 
Vibrio fetus and V. jejuni are now 
Campylobacter fetus and C. jejuni, 
respectively. 
Rabies virus — street virus should also be 
Class 2 (The only two recorded cases of 
laboratory-associated disease Were due to 
a fixed and an attenuated strain, 
respectively) 
Actinobacillus mallei is now Pseudomonas 
mallei 
Schistosoma mansoni should be a Class 2 
agent 
Psittacoses-omithoses-trachoma group 
should be redesignated Chlamydia psittaci 
and C. trachomatis and listed under Class 
2 bacteria 
Ebola fever virus should be added to the list 
of Class 4 viruses.” 
One member of the RAC, Dr. Bems, 
recommended that Rabies street virus 
be considered a Class 3 agent for the 
purposes of the Guidelines because 
although Rabies street virus could be 
classified as a Class 2 agent for work at 
diagnostic levels, larger than diagnostic 
levels will likely be used in experiments 
involving recombinant DNA techniques. 
I accept Dr. Richardson’s 
recommendations for amendment of the 
proposed classification of 
microorganisms in Appendix B, except 
that Rabies street virus will be classified 
as a Class 3 agent pending possible 
further consideration by the working 
group on classification of 
microorganisms. 
Other specific changes in Appendix B 
were discussed at the RAC meeting in 
regard to Klebsiella and other 
organisms. The RAC recommended not 
adopting these further changes at this 
time, but rather awaiting the report of 
the working group on classification of 
microorganisms at a future RAC 
meeting. 
In Appendix B of the proposed revised 
Guidelines, the working group had 
recommended that viruses classified as 
low risk oncogenic viruses by the 
National Cancer Institute Safety 
Standards for Research Involving 
Oncogenic Viruses (October 1974, U.S. 
Department of Health, Education, and 
Welfare Publication Number (NIH) 75- 
790) should be classified as Class 2 
agents for the purposes of the 
Guidelines, and moderate-risk 
oncogenic viruses should be classified 
as Class 3 agents for the purposes of the 
Guidelines. One member of the RAC 
objected to the proposed classification 
of these viruses as being too stringent. 
He suggested that the lovv-risk 
oncogenic viruses should be put in Class 
1, and the moderate-risk oncogenic 
viruses in Class 2. Because of 
differences of opinion about the 
appropriate classification for these 
viruses, because the proposed new 
designation of these agents as Class 2 
and 3 would raise required containment 
vis-a-vis the current April 21, 1982, 
Guidelines (47 FR 17180), and because 
the working group on classification of 
microorganisms will be considering this 
issue and reporting back to the RAC at 
its next meeting, I am retaining for the 
present the status of these organisms as 
they appear in the April 21, 1982 
Guidelines. 
Other than the changes discussed 
above, the RAC recommended adoption 
of Appendix B of the proposed revised 
Guidelines as published in the Federal 
Register of May 26, 1982 (47 FR 23110). I 
accept this recommendation. 
G. Appendices C through I 
The RAC recommended no changes in 
Appendices C, D, E, F, G, H, and I as 
proposed in the Federal Register of May 
26, 1982 (47 FR 23110). I accept these 
recommendations. 
H. Appendix J 
As noted in my review of Part IV of 
the Guidelines, I have accepted the 
recommendation of the RAC to add a 
new Appendix J to the Guidelines and to 
refer to this new appendix at two places 
in the text of Part IV. The new Appendix 
J provides information on the fucntions 
of the Federal Interagency Advisory 
Committee on Recombinant DNA 
Research, its membership, and a 
statement that the relevant Departments 
and Agencies have adopted the NIH 
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