Federal Register / Vol. 45, No. 22 / Thursday, January 31, 1980 / Notices 
7183 
mobilizable plasmid. He suggests that a 
distinction be made between 
nonconjugative plasmids and 
nonconjugative plasmids which are also 
poorly mobilizable; such an amendment 
would provide additional biological 
containment. The relevant portion of 
Section III-O of the Proposed Revised 
Guidelines which would be amended 
reads as follows: 
* * * Other experiments using E. coli K-12 
shall use Pi physical containment and, 
except as specified in the last paragraph of 
this section, an EK1 host-vector system (i.e., 
(a) the host shall not contain conjugation- 
proficient plasmids or generalized 
transducing phages, and (b) lambda or 
lambdoid bacteriophages or nonconjugative 
plasmids shall be used as vectors) * * \ 
The amended section proposed by Dr. 
Levy would read as follows (amended 
text in italic): 
* * * Other experiments using E. coli K-12 
shall use Pi physical containment and, 
except as specified in the last paragraph of 
this section, an EKl host-vector system (i.e., 
(a) the host shall not contain conjugation- 
proficient plasmids or generalized 
transducing phages, and (b) lambda or 
lambdoid bacteriophages or nonconjugative 
poorly mobilizable (able to be mobilized at a 
frequency of less than Iff* by a derepressed 
conjugative plasmid in the same cell) 
plasmids shall be used as vectors) * * * 
4 . Request to Eliminate Section l-D-3 
from the Guidelines. In response to the 
proposed revised Guidelines published 
in the Federal Register on November 30,' 
1979 (44 FR 69210), Dr. Clarence Kado of 
the University of California, Davis, has 
asked the NIH to consider deleting from 
the Guidelines Section I-D-3 which 
reads as follows: 
Deliberate creation by the use of 
recombinant DNA of a plant pathogen with 
increased virulence and host range beyond 
that which occurs by natural genetic 
exchange. [2A] 
Dr. Kado explains his arguments for 
elimination of the prohibition in a letter 
. to ORDA. 
5. Request to Include all Species of 
the Genus Erwinia in Appendix A, 
Sublist A. In response to the proposed 
revised Guidelines published in the 
Federal Register on November 30, 1979 
(44 FR 69210), Dr. Clarence Kado of the 
University of California, Davis, has 
requested that the NIH consider the 
inclusion of all Erwinia species in 
Sublist A, Appendix A. Currently, only 
one Erwinia species, E. amylovora, is 
included on the list. Dr. Kado suggests 
that consideration be given to all 
Erwinia species on the basis of an 
exchange of genetic material by natural 
means with E. coli and a 20% DNA- 
DNA homology of E. coli with Erwinia 
species. 
6. Classification of Plant Pathogens. 
In response to the proposed revised 
Guidelines for Research Involving 
Recombinant DNA Molecules published 
in the Federal Register on November 30, 
1979 (44 FR 69210), M. T. Goff, Animal 
and Plant Health Inspection Service, 
United States Department of 
Agriculture, has proposed that a 
classification of plant pathogens be 
included in the Guidelines. Philip D. 
Harriman, National Science Foundation, 
has also submitted a similar proposal. 
Messrs. Goff and Harriman request that 
a portion of the Report of a Workshop 
on R,jsk Assessment of Agricultural 
Pathogens, dealing with a hazard 
classification of plant pathogens, be 
included in the Guidelines. This 
Workshop was held on March 20-21, 
1978, and the report appeared as 
Appendix G to the Environmental 
Impact Assessment which accompanied 
proposed revised Guidelines published 
for comment in the Federal Register of 
July 28, 1978 (43 FR 33042). Specifically, 
they request that the following 
classification be added to Appendix B of 
the Guidelines: 
IV. Plant Pathogens 
Class 1A Agents — Plant pathogens not in 
Class IB. 
Class IB Agents — All organisms that are 
subject to quarantine restrictions for any 
of the following reasons: 
(i) Plant pathogens not known to occur in 
the United States. 
(ii) Plant pathogens that are not widely 
distributed throughout the ecological 
range of their hosts in the United States. 
(iii) Plant pathogens subject to U.S. Federal 
or State eradication or suppression 
programs. 
A USDA permit 1 is required to import or to 
move plaint pathogens across State lines. 
Footnote 2 of Appendix B of the 
proposed revised Guidelines reads as 
follows: 
USDA permit also required for import and 
interstate transport 
It is proposed that this footnote be 
modified to read as follows in order to 
serve as a single footnote for both 
animal and plant pathogens: 
1 A USDA permit, required for import and 
interstate transport of pathogens, may be obtained 
form the Animal and Plant Health Inspection 
Service, USDA Federal Building, Hyatts ville, MD 
20782. 
7. Containment Standards for Large- 
Scale Research and Production. A 
Working Group on Large-Scale Research 
and Production prepared a draft set of 
physical containment standards for 
recombinant DNA research involving 
more than 10 liters of culture. 
Comments on the draft standards 
were invited through January 10, 1980, in 
an announcement in the Federal 
Register of Novejnber 1, 1979 (44 FR 
63074). Preliminary comments were 
reviewed by the RAC at its December 6- 
7, 1979 meeting. Comments will be taken 
into account by the Working Group in 
its preparation of a revised draft. 
Revised draft standards will be 
available from ORDA on February 1, 
1980, and will be considered along with 
comments at the March 6-7, 1980 RAC 
meeting. 
If eventually approved by the NIH 
Director, the substantive standards for 
large-scale work could be combined 
with the procedural standards 
recommended by the RAC at the 
September 1979 meeting or a 
subsequently revised version. The 
combined standards could then 
constitute a new Part VII of the NIH 
Guidelines. 
8. Proposal To Amend Portions of 
Section lll-A-2-a, Viruses of 
Eukaryotes, of the Proposed Revised 
Guidelines. In portions of Section IH-A- 
2-a of the proposed revised Guidelines a 
level of biological containment requiring 
the use of “an HVl host and a vector 
certified for use in an HV2 system" has 
been substituted for "an EKl host and a 
vector certified for use in an EK2 
system.” This level of biological 
containment is abbreviated as "HVlCV” 
in Table in of the proposed revised 
Guidelines. At the December 6-7, 1979 
meeting, a working group was appointed 
to review the appropriateness of this 
level of biological containment for the 
experiments described in this section of 
the Guidelines. The working group 
proposes that HV2 biological 
containment be required for these 
experiments. Therefore, the working 
group proposes that “an HV2 host- 
vector” be substituted for "an HVl host 
and a vector for use in an HV2 system" 
in Sections IH-A-2-a-(l}-(a)-(2)-(c), HI— 
A— 2— a— (1)— (a)— (5)— (fi), III— A— 2— a— (1)— (b)— 
(iHb), III-A-2-a-(l)-(b)-(2)-(i). III-A- 
2-a-(2)-(aHJ)-(h), in-A-2-a-(2)-(a)- 
(2Hfi), and ffl-A-2-a-(2)-(c)-(2)-(6). In 
Table HI, “HV2” would be substituted 
for “HVlCV.” 
9. Request for Exemption Under 
Section I-E-4. Dr. Francis Macrina of 
the Virginia Commonwealth University 
has proposed that Streptococcus mutans 
and Streptococcus sanguis be included 
under the exemption category of Section 
I-E-4 of the Guidelines on the basis that 
these bacteria have been shown to 
exchange chromosomal DNA by known 
physiological processes. These two 
organisms would then constitute a new 
Sublist of Appendix A. 
10. Request for Approval to Clone 
Exotoxin A Gene of Pseudomonas 
aeruginosa. Dr. C. W. Shuster of Case 
Western Reserve University has 
requested the RAC to consider whether 
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