Federal Register / Vol. 44, No. 232 / Friday, November 30, 1979 / Notices 
69247 
derived from £ coli K-12 and Streptomycea 
coelicolor using NIH-approved 
Staphylococcus aureus plasmids as vectors 
under P2 conditions. 
(b) Streptomycea coelicolor can be used as 
a host for the cloning of DNA derived from B. 
aubtilia, £ coli K-12, or from £ aureus 
vectors that have been approved for use in B. 
subtilis under P2 conditions. 
During the 30-day comment period, no 
comments were received. 
This proposal had been discussed at 
the February and May 1979 RAC 
meetings. At the September RAC 
meeting, after discussion of the safety of 
these systems including the issue of 
spore formation, the final votes on these 
proposals were 9 in favor, none 
opposed, with 8 abstentions, to approve 
part (b) dealing with cloning in 
Streptomycea coelicolor, and 8 in favor, 
5 opposed, with 5 abstentions, to 
approve part (a) dealing with cloning in 
Bacillus subtilis. 
I propose to accept these 
recommendations, and they have been 
inserted into Appendix E of the 
proposed revised Guidelines. 
Use of Agrobacterium Tumefaciens as a 
Host- Vector System 
The following notice appeared for 
comment in the Federal Register on July 
31. 1979; 
At iU May 21-23. 1079, meeting, the RAC 
recommended approval at the P3 level of 
physical containment of specific experiments 
involving Introduction of well-characterized 
fragments of eukaryotic DNA into 
Agrobacterium tumefaciens carrying a Ti 
plasmid, using an EK2 plasmid vector 
coupled to a fragment of the TI plasmid and/ 
or the origin of replication of a cryptic A. 
tumefaciens plasmid, and introduction of 
these bacteria into plant parts or cells in 
culture under P3 conditions. Approval is now 
requested by Dr. M. D. Chilton for 
modification of the experimental procedure 
as follows: 
Cloned desired fragments from any non- 
prohibited source may be transferred into 
Agrobacterium tumefaciens containing a TI 
plasmid (or derivatives thereof), using a non- 
conjugative £ coli plasmid vector coupled to 
a fragment of the Ti plasmid and/or the origin 
of replication of an Agrobacterium plasmid, 
under containment conditions one step higher 
than would be required for the desired DNA 
in EKl or HVl systems. Transfer into plant 
parts or cells In culture would be permitted at 
the same containment level (one step higher). 
During the 30-day comment period, no 
comments were received. 
At the September RAC meeting, after 
discussion of the safety of this system, a 
motion to approve this proposal passed 
by a vote of 9 in favor, 8 opposed with 2 
abstentions. 
I propose to accept this 
recommendation and have inserted into 
Appendix E of the proposed revised 
Guidelines the text as it appeared in the 
July 31 Federal Register — i.e., “Cloned 
desired fragments. . . . (one step 
higher)" — with one change in wording. 
This change necessitated by my 
proposed action on the "E. coli K-12/P1 
Recommendation” (see Part IU of this 
announcement above), is to substitute 
for the words “. . . in EKl or HVl 
systems . . ." the words "... in HVl 
systems (Le., one step higher physical 
containment than that specified in the 
subsections of Section HI— A) . . ." 
Proposed Supplement to the NIH 
Guidelines 
The 1978 Guidelines say in Section 
IV-F-4. "(Provisions for protection of 
proprietary information as permitted 
under current DHEW authorities will be 
proposed as a future supplement to 
these Guidelines.)" 
On August 3, 1979, there was 
published in the Federal Register, for 
public comment, a proposed supplement 
to the NIH Guidelines. 
The August 3 Federal Register notice 
first contained background information 
as follows: 
On December 22, 1978. the Director. 
National Institutes of Health, with the 
approval of the Assistant Secretary for 
Health and the Secretary of Health. 
Education, and Welfare, issued revised 
Guidelines for Research Involving 
Recombinant DNA Molecules (43 FR 60108], 
These Guidelines were accompanied in the 
Federal Register by a Notice of Intent to 
Propose Regulations issued by the Food and 
Drug Administration. In addition, the 
Secretary sent letters to Administrator 
Douglas Costle, Environmental Protection 
Agency, and to Secretary of Agriculture Bob 
Bergland. requesting comparable actions to 
ensure a commonality of standards 
throughout the private sector. In July the 
Secretary sent a similar request to Secretary 
of Labor Ray Marshall. 
Several responses to the FDA notice 
questioned that agency's legal authority to 
regulate private research in this field. In view 
of these comments. NIH Director Donald S. 
Fredrickson and the Commissioner of Food 
and Drugs. Donald Kennedy, developed a 
draft supplement to the NIH Guidelines that 
would extend them on a voluntary basis to 
industry. This draft was reviewed by Peter 
Libassi. then General Counsel for the 
Department, who also consulted with 
representatives from the pharmaceutical 
industry and from public interest and 
environmental organizations. The 
representatives from the pharmaceutical 
industry considered the. supplement to 
provide a feasible basis for voluntary 
compliance; the representatives from the 
other groups considered a voluntary system 
insufficient and urged that mandatory 
compliance be achieved through legislation 
or regulation. 
In light of those discussions it was agreed 
that the draft supplement prepared by NIH 
and FDA should also be reviewed by the 
Federal Interagency Advisory Committee on 
Recombinant DNA Research which includes 
all relevant Federal research and regulatory 
agencies. This Committee, created in October 
1978 to consider extension of the Guidelines 
nationally, had. recommended in March 1977 
that legislation be developed. On July 18, 
1979, the Committee met to consider the draft 
supplement and alternative approaches to 
extent the revised NIH Guidelines to the 
private sector. It was the Committee’s 
unanimous opinion that NIH should proceed 
to publish for public comment the draft 
supplement to the NIH Guidelines. The 
conclusion was not unanimous that the 
voluntary approach would achieve complete 
compliance within the private sector. 
On the basis of the recommendations by 
the Interagency Committee, the Director, NIH, 
invites public comment on the proposed 
supplement to the NIH Guidelines, which is 
set forth below * * * 
The August 3 Federal Register notice 
then gave the text of proposed sections 
to be added to the Guidelines. The full 
text is not repeated in this 
announcement The headings of the 
proposed sections are; 
IV-G--5. Voluntary Compliance.; VI. 
Voluntary Compliance.; VI-A. Basic 
Policy.; VI-B. IBC Approvals VI-C. 
Registration.; VI-D. Certification of 
Host-Vector Systems.; VI-E. Request for 
Exceptions.; and VI-F. Protection of 
Proprietary Data. 
During the 30-day comment period, 
five letters were received. 
A representative of the AFL-CIO 
wrote: 
We firmly believe that regulatory authority 
over health and safety of workers must be the 
responsibility of the Occupational Safety and 
Health Administration. Promulgation of your 
Inadequate and impotent Guideline additions 
can only hamper efforts to provide proper 
oversight by OSHA. Therefore, these 
Guideline sections should not be adopted. 
NIH has no business intruding upon the 
affairs of non-grantees or other government 
agencies. 
A representative of the Environmental 
Defense Fund wrote: 
In the absence of statutory authority 
enabling NIH inspection and enforcement of 
industrial experiments and providing for stiff 
penalties for violations, approval is a 
meaningless exercise. Indeed, its only benefit 
is to the industrial sponsor, who is then free 
to proclaim that its experiments are safe and 
above public concern. From a political 
standpoint we fear that a voluntary program, 
no matter how insufficient will provide a 
public relations weapon to industry and an 
argument against mandatory control * * * 
voluntary compliance programs have never 
worked and never will. 
Dr. Susan Wright wrote that the 
"proposal is ill-advise * * * ‘voluntary 
compliance' means that the private 
sector will obey the guidelines when it is 
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