7442 * 
Federal Register / Vol. 55. No. 41 / Thursday, March 1. 1990 / Notices' 
Appendix H-t 
An illustration of one method of packaging 
and labeling of recombinant DNA-containing 
anicroorganisms and viral genomes defined as 
etiologic agents in the Preamble is shown in 
Figures 1. 2. and 3. Additional information on 
packaging and shipping is given in the 
Laboratory Safety Monograph — A 
Supplement to the NIH Guidelines for 
.s Recombinant DNA Research, available from . 
the Office of Recombinant DNA Activities 
and in the publication Biosafety in 
Microbiological and Biomedical 
Laboratories.* 
Appendix H-II — ^Footnote and References of 
Appendix H. 
B. Proposed Replacement of the Illustration in 
Appendix H. 
The heading changes and the replacement 
paragraph were written by NIH stafi on 
December 12. 1988, to reflect the intent of the 
Detinitiona Subcommittee of the RAC. 
The replacement paragraph would read: 
Figtires 1. 2, and 3 depict one method for 
the packaging and labeling of those 
recombinant DNA-containing organisms and . 
viral genomes defined as etiologic agents in 
the Preamble of Appendix H. The key 
features are identihed in Figure 1. It is the 
responsibility of the shipper to comply with 
the app licab le requirements of 42 CFR part 72 
and 49 CFR part 173 when shipping biological 
mater-els or etiologic agents. It is 
ended that aU organisms containing 
recombinant molecules, which are exempt 
and/or Class 1 agents, should be shipped in 
secure, leak-proof containers. 
' (See illustration in Federal Register of 
December 30. 1988 (53 FR 33266)). 
The proposal was published for 
comment in the Federal Register of 
December 30. 1988 (53 ER 53262). 
vAfter .considering this proposal at the 
January 30. 1989, meeting, the RAC 
members agreed that it solved 90 
b .jjercenLof .the difficulties posed by the . ^ 
- original version, but that additional 
work was needed. 
The Definitions Subcommittee met on 
July 12, 1989, and adopted the following 
motion: 
To recommend to the Recombinant DNA 
Advisory Committee consideration and 
adoption of the following amendment to 
Appendix H of the NIH Guidelines for 
Research Involving Recombinant DNA 
Molecules: 
Appendix H is to be replaced as follows: 
Appendix H — Shipment 
Recombinant DNA molecules contained in 
an organism or in a viral genome shall be 
shipped under the applicable regulations of 
the U.S. Postal Service; the U.S. Public Health 
. Service (42 CFR part 72); the U3. Department 
* "Biosafety in Microbial and Biomedical 
-''rLaboratoriea. 2nd Edition. (May 1983). US. 
' DeparUnenl of Health and Human Services. Centers 
for Disease Control Atlanta.'Ceorgia 30333. and 
National Institutes of Health. Bethesda. Maryland 
20892." 
of Agriculture (9 CFR subchapters D and E; 7 
CFR part 340); and/or the U.S. Department of 
Transportation (49 CFR parts 171-179). 
For purposes of the NIH Guidelines: 
Host organisms or viruses will be defined 
as etiologic agents regardless of whether or 
not they contain recombinant DNA if they are 
regulated as human pathogens by the U.S. 
Public Health Service (42 CFR part 72) or as 
-animal pathogens or plant pests under the 
Animal and Plant Health l^pection Service " 
(APHIS), U.S. Department of Agriculture 
(titles 9 and 7 CFR. respectively). 
Additionally, host organisms and viruses 
will be defined as etiologic agents if they 
contain recombinant DNA when; 
A the recombinant DNA includes the 
complete genome of a host organism or virus 
regulated as a human or animal pathogen or a 
plant pest or 
B. the recombinant DNA codes for a toxin 
or other factor directly involved in eliciting 
human, animal or plant disease or inhibiting 
plant growth and is carried on an expression 
vector or within the host chromosome and/or 
when the host organism contains a 
conjugation proficient plasmid or a 
generalized transducing phage; or 
C the recombinant DNA comes from a host 
organism or virus regulated as a human or 
animal pathogen or as a plant pest and has 
not been aequately characterized to 
demonstrate that it does not code for a factor 
involved in eliciting human, animal or plant 
disease. 
Appendix H-1 — Footnotes and References of 
Appendix H. 
- For further infonnation on shipping 
etiologic agents, please contact (1) Centers 
for Disease Control ATTN: Biohazards 
Control Office. 1600 Clifton Road. Atlanta. 
Georgia 30333, (404) 639-3883. FTS 236-3883; 
(2) Department of Transportation. ATTN: 
Office of Hazardous Materials 
Transportation. 400 7th Street SW„ 
Washington. DC 20590. (202) 366-4545: or (3) 
Department of Agriculture. ATTN: Animal & 
Plant Health Inspection Service. 6505 Belcrest 
" Road. Hyattsville. Maryland 20782, (301) 436- 
7885 for Animal Pathogens, (301) 436-7612 for 
Plant Pests. 
The proposal was published for 
comment in the Federal Register of 
September 1, 1989 (54 FR 36698). 
The RAC considered this proposal at 
the October 6, 1989, meeting. 
The RAC voted to adopt the following 
revision of Appendix H to the NIH 
Guidelines by a vote of 15 in favor, none 
opposed, and no abstentions: 
Appendix H — Shipment 
> Recombinant DNA molecules contained in 
an organism or in a viral genome shall be 
shipped under the applicable regulations of 
the U.S. Postal Service (39 CFR part ID); the 
.4 U.S. Public Health Service (42 CTR part 72); 
the U.S. Department of Agrioilture (9 CFR 
subchapters D and E; 7 CFR part 340); and/ or 
the U.S. Department of Transportatipn (49 
CFR parts 171-179). 
For purposes of the NIH Guidelines: 
Host organisms or viruses will be shipped 
as etiologic agents regardless of whether or 
not they contain recombinant DNA if they are 
regulated as human pathogens by the U.S. 
Public Health Service (42 CFR part 72) or as 
animal pathogens or plant pests imder the 
Animal and Plant Health Inspection Service 
(APHIS), U.S. Department of Agriculture 
(titles 9 and 7 CFR, respectively). 
Additionally, host organisms and viruses 
%vill be shipped as etiologic agents if they 
contain recombinant DNA when: 
A the recombinant DNA includes the 
complete genome of a host organism or virus 
regulated as a human or animal pathogen or a 
plant pest or 
B. the recombinant DNA codes for a toxin 
or other factor directly involved in eliciting 
human, animal or plant disease or inhibiting 
plant growth and is carried on an expression 
vector or within the host chromosome and/or 
when the host organism contains a 
conjugation proficient plasmid or a 
generalized transducing phage; or 
C the recombinant DNA comes from a host 
organism or virus regulated as a human or 
animal pathogen or as a plant pest and has 
not been adequately characterized to 
demonstrate that it does not code for a factor 
involved in eliciting human, animal or plant 
disease. 
_ Appendix H-1 — Footnotes and References 
of Appendix H. 
For further information on shipping 
etiologic agents, please contact: (1) Centers 
for Disease Control. ATTN: Biohazards 
Control Office. 1600 Clifton Road. Atlanta. 
Georgia 30333, (404) 639-3883. FTS 236-3883: 
(2) Department of Transportation. ATTN: 
Office of Hazardous Materials 
Transportation. 400 7th Street, SW„ 
Washington, DC 20390, (202) 366-4545: or (3) 
Department of Agriculture, ATTN: Animal & 
Plant Health Inspection Service. 6505 Belcrest 
Road. Hyattsville. Marj'land 20782. (301) 436- 
7885 for Anrmai Pathogens, (301) 436-7612 for 
. Plant Pests. 
I accept this recommendation and 
. Appendix H has been modified • 
- accordingly. 
D. Proposed Amendment of Appendix A, 
Sublist A, and Appendix B-I-^1 of the 
NIH Guidelines Regarding Klebsiella 
oxytoca. 
In a letter dated August 3. 1989. Dr. 
Rogers Yocum, Director, Biochemical 
Products and Processes. Biotechnica 
International, Cambridge, 
Massachusetts, requests that certain 
experiments involving all strains 
derived from Klebsiella oxytoca strain 
M5al be given exempt or BLl status 
imder the NIH Guidelines. 
In his August 3. 1989. letter. Dr. Yocum 
states: 
, . .. 3ioTechnica International. Inc. would like 
to request that certain experiments involving 
all strains derived from Klebsiella oxytoca 
•train M5al be given exempt or BLl status in 
the NIH Guidelines for Recombinant DNA 
Research. We believe that K oxi'toca M5al 
has had a long history of safe use in many 
laboratories and that BLl contaiomeht should 
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Recombinant DNA Research, Volume 14 
