Federal Register / Vol. 53. No. 251 / Friday, December 30, 1988 / Notices 
53269 
identical to organisms created with 
recombinant DNA techniques. 
RAC members acknowledged the 
deficiencies in the current Guidelines at June 
3, 1968. meeting in a discussion of 
amendments to the Guidelines regarding 
transgenic animals (14. 15. 16). Certain 
experiments with transgenic animals are not 
subject to the Guidelines because the DNA 
added to the animals is not “recombinant 
DNA" as defined by the Guidelines. 
According to meeting participants, 
there is a serious and significant 
loophole that needed to be addressed * * *” 
(16. p. 18); 
• the technology exists to create non- 
recombinant transgenic organisms (“* * * 
the technology is moving fast enough that by 
the time this [transgenic animal amendment] 
went anyplace that there will be such things", 
(16, p. 26); 
• some transgenic organisms pose hazards 
(“* * * if you're injecting DNA into an 
animal * * * you’ve potentially created 
something that might be harmful, so you 
shouldn't let it wild. You couldn't let it out 
into the wild.” (16, p. 39). 
Summary 
Gene transfer technology has now moved 
beyond recombinant DNA techniques. The 
NIH should delay no longer in developing 
Guidelines that reflect current scientific 
knowledge so that the public and the 
environment are protected from potential 
hazards of the new gene transfer 
technologies. There is no scientific rationale 
for limiting oversight to one subset of 
genetically novel organisms. 
We urge the RAC to recommend to the NIH 
Director that the Guidelines be updated and 
expanded to encompass all organisms 
possessing the same degree of genetic novelty 
as organisms produced by recombinant DNA 
techniques as currently defined. 
We look forward to the RAC's 
consideration of this request at the January, 
1989, meeting. Please call (797-6892) if you 
have any questions. 
Sincerely. 
Jane Rissler, 
National Biotechnology Policy Center. 
References 
1. U.S. Department of Health, Education, 
and Welfare, National Institutes of Health. 
1976. Recombinant DNA Research: 
Guidelines. Federal Register 41:27902-27943. 
2. U.S. Department of Health, Education, 
and Welfare, National Institutes of Health. 
1977. Environmental impact statement on 
NIH Guidelines for Research Involving 
Recombinant DNA Molecules. Part One. 
DHW Publication No. (NH1) 1469, Bethesda, 
MD. 
3. U.S. Department of Health and Human 
Services, National Institutes of Health. 1986. 
Guidelines for Research Involving 
Recombinant DNA Molecules. Federal 
Register 51:16958-16985. 
4. Boynton. J.E., N.W. Gillham. E.H. Harris, 
J.P. Hosier. A.M. Johnson. A.R. Jones. B.L 
Randolph-Anderson, D. Robertson, T.M. 
Klein, K.B. Shark, and J.C. Sanford. 1988. 
Chloroplast transformation in 
Chlamydomonas with high velocity 
microprojectiles. Science 240:1534-1538. 
5. Hammer, R.E.. V.G. Pursel, C.E. Rexroad, 
R.J. Wall, D.J. Bolt, K.M. Ebert. R.D. Palmiter. 
and R.L Brinster. 1985. Production of 
transgenic rabbits, sheep and pigs by 
microinjection. Nature 315:680-682. 
6. Johnston. S.A., P.A. Anziano, K. Shark. 
J.C. Sanford, and R.A. Butow. 1988. 
Mitochondrial transformation in yeast by 
bombardment with microprojectiles. Science 
240:1538-1541. 
7. Klein, T.M., T. Gradziel, M.E. Fromm, 
and J.C. Sanford. 1988. Factors influencing 
gene delivery into Zea mays cells by high- 
velocity microprojectiles. Bio/Technology 
6:559-563. 
8. Klein. T.M., E.D. Wolf, R. Wu, and J.C. 
Sanford. 1987. High-velocity microprojectiles 
for delivering nucleic acids into living cells. 
Nature 327:70-73. 
9. McCabe, D.E., W.F. Swain, B.J. Martinell, 
and P. Christou. 1988. Stable transformation 
of soybean ( Glycine max) by particle 
acceleration. Bio/Technology 6:923-926. 
10. Morikawa, H., K. Sugino, Y. Hayashi, J. 
Takeda, M. Senda, A. Hirai, and Y. Yamada. 
1986. Interspecific plant hybridization by 
electrofusion in Nicotiana. Bio/Technology 
4:57-60. 
11. Nishiguchi, M.. W.H.R. Langridge. A.A. 
Szalay, and M. Zaitlin. 1986. Electroporation- 
mediated infection of tobacco leaf 
protoplasts with tobacco mosaic virus RNA 
and cucumber mosaic virus RNA. Plant Cell 
Reports 5:57-60. 
12. Sanford. J.C., T.M. Klein, E.D. Wolf, and 
N. Allen. 1987. Delivery of substances into 
cells and tissues using a particle 
bombardment process. Particulate Science 
and Technology 5:27-37. 
13. Toneguzzo, F. and A. Keating. 1986. 
Stable expression of selectable genes 
introduced into hematopoietic stem cells by 
electric field-mediated DNA transfer. 
Proceedings National Academy of Science 
83:3496-3499. 
14. U.S. Department of Health and Human 
Services, National Institutes of Health. 1988. 
Recombinant DNA Research Guidelines and 
Advisory Committee Meeting; Notices. 
Federal Register 53:12753-4. 
15. U.S. Department of Health and Human 
Services. National Institutes of Health, 
Working Group on Transgenic Animals. 
Recombinant DNA Advisory Committee. 
1988. Minutes of meeting. March 28. 1988. 
Recombinant DNA Technical Bulletin 11:25- 
30. 
16. U.S. Department of Health and Human 
Services, National Institutes of Health, 
Recombinant DNA Advisory Committee. 
1988. Transcript of the June 3, 1988, meeting. 
StenoTech, Inc., Gaithersburg, MD. 
OMB’s "Mandatory Information 
Requirements for Federal Assistance 
Program Announcements" (45 FR 39592) 
requires a statement concerning the 
official government programs contained 
in the Catalog of Federal Domestic 
Assistance. Normally NIH lists in its 
announcements the number and title of 
affected individual programs for the 
guidance of the public. Because the 
guidance in this notice covers not only 
virtually every NIH program but also 
essentially every Federal research 
program in which DNA recombinant 
molecule techniques could be used, it 
has been determined to be not cost 
effective or in the public interest to 
attempt to list these programs. Such a 
list would likely require several 
additional pages. In addition, NIH could 
not be certain that every Federal 
program would be included as many 
Federal agencies, as well as private 
organizations, both national and 
international, have elected to follow the 
NIH Guidelines. In lieu of the individual 
program listing, NIH invites readers to 
direct questions to the information 
address above about whether individual- 
programs listed in the Catalog of Federal 
Domestic Assistance are affected. 
Dated: December 23, 1988. 
William F. Raub, 
Acting Director. National Institutes of Health. 
[FR Doc. 88-30076 Filed 12-29-88; 8:45 am] 
BILUNG CODE 4140-01-11 
[330] 
Recombinant DNA Research, Volume 13 
