Appendix H-III. Footnotes
and References of Appendix H
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 Code of Federal Regulations, Part 3); the Public Health
Service (42 Code of Federal Regulations, Part 72); the U.S. Department of
Agriculture (9 Code of Federal Regulations, Subchapters D and E; 7 CFR, Part
340); and/or the U.S. Department of Transportation (49 Code of Federal
Regulations, Parts 171-179).
Note. A
host-vector system may be proposed for certification by the NIH Director in
accordance with the procedures set forth in Appendix I-II, Certification of
Host-Vector Systems. In order to
ensure protection for proprietary data, any public notice regarding a
host-vector system which is designated by the institution as proprietary under Section
IV-D, Voluntary Compliance, will be issued only after consultation
with the institution as to the content of the notice (see Section
IV-D-3, Certification of Host-Vector Systems - Voluntary Compliance).
Appendix H-I.
Host organisms or viruses will be shipped as etiologic agents,
regardless of whether they contain recombinant DNA, if they are regulated as
human pathogens by the Public Health Service (42 Code of Federal Regulations,
Part 72) or as animal pathogens or plant pests under the U.S. Department of
Agriculture, Animal and Plant Health Inspection Service (Titles 9 and 7 Code of
Federal Regulations, respectively).
Appendix H-II.
Host organisms and viruses will be shipped as etiologic agents if they
contain recombinant DNA when: (i) 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 (ii) 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 (iii) 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.
For further information on shipping etiologic agents
contact: (i) The Centers for Disease Control and Prevention,
ATTN: Biohazards Control Office, 1600
Clifton Road, Atlanta, Georgia 30333, (404) 639-3883, FTS 236-3883; (ii) The
U.S. Department of Transportation, ATTN:
Office of Hazardous Materials Transportation, 400 7th Street, S.W.,
Washington, DC 20590, (202) 366-4545; or (iii) U.S. Department of Agriculture,
ATTN: Animal and Plant Health Inspection Service
(APHIS), Veterinary Services, National Center for Import-Export, Products
Program, 4700 River Road, Unit 40, Riverdale, Maryland 20737. Phone:
(301) 734-8499; Fax: (301)
734-8226.