Federal Register / Vol. 55, No. 41 / Thursday, March 1, 1990 / Notices 
7441 
Recambinant DNA Activities, National* 
Institutes of Health. Building^Sl. room 4£ll. 
£ethesda3'Iaryland 20SSZ. 
' Guidelines for Research Involving -m 
Recombinant DNA Molecules. NIH, 1986. 
Available from the Office of Recombinant 
DNA Activities. National Institutes of Health. 
Building 31. room 4B11. Bethesda. Maryland 
.20892. 
W. French Anderson, Prospects for Human 
Gene Therapy in the Bom and Unborn 
Patient, Clincal Obstetrics and Gynecology, 
29(3): 586-594; September 1986. 
W. French Anderson and John C Retcher. 
Gene Therapy in Human Beings: V/hen Is II 
Ethical to Begin? New England Joamal of- 
Medicine 202 (22): 1292-1297; November 27, 
1980. 
Council of Europe. Parliamentary 
Assembly. Recommendation 934 (1962) on 
Genetic Engineering, adopted by the 
Assembly January 26. 1982. 
Institute of Medidne. National Academy of 
Sdences, and Eve K. Nichols. Human Gene 
Therapy (Cambridge. Mass.: Harvard 
University Press. 1988). 
Jeff Lyon and Peter Gomer.AlteredFates — 
The Promise of Gene Therapy (Chicago. IL: 
Chicago Tribune Company, 1988). Available 
from the Office of Recombinant DNA 
Activities. National Institutes- of Health, 
building 31. room 4B11, Bethesda. Maryland 
20892. 
Amo G. Motulsky, Impact of Genetic 
Manipulation on Sodety and Medicine. 
Science 219 (4SS1J; 135-140; January 14. 1983, 
National Coundl of the Churches of Chnst 
in the United States of America. Genetic 
Sdence for Human Benefit. Adopted by the 
Governing Board. May 1986. Available from 
the Office of the General Secretary. National 
Coundl of Churches, 475 Riverside Drive, 
room 880, New York. NY 10115. 
Maya Pines, The New Human Genetics; 
Human Gene Splicing Helps Researchers ' ' ' 
Fight Inherited Disease (Bethesda. MD: 
National Institute of General Medical 
Sdences. September 1984). Available from 
the National Institute of General Medical 
Sdences. National Institutes of Health, 
building 31. room 4A52. Bethesda. Maryland 
20892. 
Jeremy Rifkin. in collaboration with 
Nicanor Perlas, Algcny (New York. Viking, 
1983). 
US.. President's Commission for the Study 
of Ethical Problems in Medicine end 
Biomedical and Behavioral Research. Splidng 
I Life: A Report on the Sodal and Ethical 
I Issues of Genetic Engineering with Human 
Beings (Washington. DC' US. Government 
I Printing Office. November 1982). Available 
I from the US. GoN*emment Printing Office. 
Superintendent of Documents. Washington, 
j DC 2£M02. 
I U.S., Congress, Office of Technology 
I Assessment, Human Gene Therapy, 
j Background Paper (Washington. DC: OTA, 
' December 1984). Available from the US. 
Government Printing Office. Superintendent 
of Documents. Washington. DC 20402. 
US., Congress,' Office of Technology 
Assessment Background Paper. Public 
I Perceptions of Biotechnology (Washington, 
j DC OTA. May 1987). Chapter 8. Available 
from the US. Government Printing Office. 
Superintendent of Documents. Washington. 
DC 20402. 
LeRoy Walters, The Ethics of Human Gene 
^^Therapy. Nature 320 (6059): 225-227; March 
20. 1986. 
Worid Coundl of Churches, Working 
Committee on Church and Sodety, 
. Manipulating Life: Ethical Issues in Genetic 
Engineering. Geneva: Church and Society. 
World Coundl of Churches, 1982. 
World Medical Assodation. Statement on 
Genetic Counseling and Genetic Engineering. 
39th World Medical Assembly. Madrid, 
Spain. October 1987. 
AUDIOVISUAL RESOURCE 
The Genetic Gamble, a NOVA Program 
first aired on the Public Broadcasting System 
in 1985. Available as a videotape from 
Coronet-MTI Film and Video. 108 Wilmot 
Road. Deerfield. IL 60015, phone: (300) 621- 
2131. Rental cost S99; purchase price: S350. 
PART S-LIST OF CONTRIBUTORS 
Recombinant DNA Advisory Committee 
Human Gene Therapy Subcommittee 
Anderson. W. Frendu MJ).. Laboratory of 
Molecular Hematology. National Heart 
tjing & Blood Institute 
Areen. Judith, J.D_* Dean. Georgetown 
University Law Center 
Axel, Richard. M.D.. Howard Hughes Medical 
Institute. Columbia University 
Brewer. Michael F„ J JX. Govenunent 
Relations. Dun and Bradstreet Corporation 
Capron. Alexander. H-R , The Law Center, 
University of Southern California 
Childress, James F„ PhD.. Department of 
Religious Studies, University of Virginia 
Epstein. Charles J.. MD.. Department of 
Pediatrics, University of California, San 
Francisco 
Erickson. Robert P„ MD.. Division of 
■; ^Pediatric Genetics, University of Michigan - 
Medical Center 
. Gorovitz. Samuel PhD.. Dean of Arts and 
. Sciences. Syracuse University 
Gottesman. Susan 1C, PhD.. Laboratory of 
Molecular Biology, National Caiu:er 
Institute 
Grobstein. Clifford. PhD.. Department of 
Science, Technology. & Public Affairs. 
University of California. San Diego 
Kelley. William N.. MD.. Department of 
Internal Medicine, University of Michigan 
Medical Center 
Mahoney. Maurice )„ MD.,* Department of 
1 Human Genetics; Yale University 
' Mclvor. R. Scott, PhD., Institute of Human 
Genetics. University of Minnesota 
Mitchell. Robert E„ ULB. (Ex-officio), 
, Attorney at Law, Norwalk, California 
-Motulsky, Amo G.. MD„ Department of 
Medicine, University of Washington 
Mulligan, Richard C, PhD.. Whitehead 
Institute for Biomedical Research. 
.Massachusetts Institute of Technology - . 
. Murray. Robert F, M.D., Division of Medical 
Genetics. Howard University 
. Neiman, Paul E.. MD., Associate Director for 
Basic Sciences, Fred Hutchinson Cancer 
Research Center 
* Member. Public information Braebure Working 
Croup 
Parkman. Robertson. MD.. Division of 
Research Immunology — Bone Marrow 
Transplantation. Childrens Hospital of Los 
Angeles 
Rich. Robert F, PhD.. Institute of 
Governmental and Public. Affairs, 
-University of Illinois 
Varmus. Harold- MD_ Department of 
Microbiology'. University of California. San 
Francisco 
Walters, LeRoy. PhD,* Center for Bioethics, 
Kennedy Institute of Ethics. Georgetown 
University 
Witherby. Anne R, B.A,** 2 Commonwealth 
Avenue, Boston. Massachusetts 
I accept this dooiment as education 
material on human gene therapy that 
will be distributed by NIH. 
C. Proposal to Amend Appendix H of 
the NIH Guidelines. 
*rhe Federal Register of June 24. 1988 
(53 FR 23775], contained a proposal by 
the Postal Service to ban the shipment 
of all etiologic agents, or materials * 
believed to contain etiologic agents, as 
defined by the Department of 
Transportation and the Department of 
Health and Human Services regulations. 
Under Appendix K of the current NIH 
Guidelines for Research Involving 
Recombinant DNA Molecules of May 7, 
1986 (52 FR 16976), this ban could apply 
to all shipments of recombinant 
molecules contained within, an organism 
or virus, regardless of whether they are 
potentially hazardous to human health 
Such a ban could affect the terms and 
conditions imder which commercial 
shippers would transport recombinant 
•DNA products. The RAC recognized the 
potential significance of this issue and 
referred it to the Definitions 
Subcommittee of the RAC, which met on 
December 5, 1988, and developed the 
following proposab 
A Proposed Replacement of Appendix H. 
Preamble: 
Recombinant DNA molecules contained in 
an organism or in a viral genome shall be 
shipped under the appropnate requirements 
of the U.S. Public Health Service (42 CIR, 
part 72), U.S. Department of A griculture (9 
CFR. subchapters D&E; 7 CFR, part 340) and/ 
. or the U5. Department of Transportation (49 
CFR. part 173). For purposes of these 
Guidelines the followng recombinant DNA 
molecules contained in aruorganism or in a 
viral genome shall be shipped as etiologic 
agentsr(l) Those listed as Class 2, 3, or 4 
agents in Appendix D: and/or (2) those 
.. \ contained in reference G-III-2*i and/or (3) 
' those regulated as animal or plan t pathogens 
or pests under titles 7 and 9 CFR; or (4) host 
organisms containing recombinant DNA 
derived from those organisms or viral 
genomes. 
••.Chair. Public Information Brochure Working 
Croup 
Recombinant DNA Research, Volume 14 
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