77404 
Federal Register / Vol. 45, No. 227 / Friday, November 21, 1980 / Notices 
For use as a vector in a vertebrate host cell 
system, an animal viral DNA molecule should 
display the following properties: 
(i) It should not consist of the whole 
genome of any agent that is infectious for 
humans or that replicates to a significant 
extent in human cells in tissue culture. If the 
recombinant molecule is used to transform 
nonpermissive cells (i.e., cells which do not 
produce infectious virus particles), this is not 
a requirement. 
(ii) It should be derived from a virus whose 
epidemiological behavior and host range are 
well understood. 
(iii) In permissive cells, it should be 
defective when carrying an inserted DNA 
segment (i.e., propagation of the recombinant 
DNA as a virus must be dependent upon the 
presence of a complementing helper genome). 
In almost all cases this condition would be 
achieved automatically by the manipulations 
used to construct and propagate the 
recombinants. In addition, the amount of 
DNA encapsidated in the particles of most 
animal viruses is defined within fairly close 
limits. The insertion of sizable foreign DNA 
sequences, therefore, generally demands a 
compensatory deletion of viral sequences. It 
may be possible to introduce very short 
insertions (50-100 base pairs) without 
rendering the viral vector defective. In such a 
situation, the requirement that the viral 
vector be defective is not necessary, except 
in those cases in which the inserted DNA 
encodes a biologically active polypeptide. 
It is desired but not required that the 
functional anatomy of the vector be known — 
that is, fL-re sLogld be a clear idea of the 
location within the molecule of: 
(i) the sites at which DNA synthesis 
originates and terminates, 
(ii) the sites that are cleaved by restriction 
endonucleases, and 
(iii) the template regions for the major gene 
product. 
If possible the helper virus genome should: 
(i) be integrated into the genome of a stable 
line of host cells (a situation that would 
effectively limit the growth of the vector 
recombinant to such cell lines) or 
(ii) consist of a defective genome, or an 
appropriate conditional lethal mutant virus, 
making vector and helper dependent upon 
each other for propagation. 
However, neither of these stipulations is a 
requirement. 
45. Review of NIH on a case-by-case basis 
means that NIH must review and set 
appropriate containment conditions before 
the work may be undertaken. NIH actions in 
such case-by-case reviews will be published 
in the Recombinant DNA Technical Bulletin. 
46. Provided the inserted DNA sequences 
are not derived from eukaryotic viruses. In 
the latter case, such experiments will be 
evaluated on a case-by-case basis. 
47. >99% pure; otherwise as for shotgun 
experiments. 
48. A USDA permit, required for import and 
interstate transport of pathogens, may be 
obtained from the Animal and Plant Health 
Inspection Service, USDA, Federal Building, 
Hyattsville, MD 20782. 
49. A subset of non-conjugative plasmid 
vectors are also poorly mobilizable (e.g., 
pBR322, pBR313). Where practical, these 
vectors should be employed. 
50. i.e., the total of all genomes within a 
Family shall not exceed two-thirds of the 
genome. 
VI. Voluntary Compliance 
VI-A. Basic Policy. Individuals, 
corporations, and institutions not 
otherwise covered by the Guidelines are 
encouraged to do so by following the 
standards and procedures set forth in 
Parts I-IV of the Guidelines. In order to 
simplify discussion, references hereafter 
to “institutions” are intended to 
encompass corporations, and 
individuals who have no organizational 
affiliation. For purposes of complying 
with the Guidelines, an individual 
intending to carry out research involving 
recombinant DNA is encouraged to 
affiliate with an institution that has an 
Institutional Biosafety Committee 
approved under the Guidelines. 
Since commercial organizations have 
special concerns, such as protection of 
proprietary data, some modifications 
and explanations of the procedures in 
Parts I-IV are provided below, in order 
to address these concerns. 
VI-B. IBC Approval. The NIH Office 
of Recombinant DNA Activities (ORDA) 
will review the membership of an 
institution's Institutional Biosafety 
Committee (IBC) and, where it finds the 
IBC meets the requirements set forth in 
Section IV-D-2, will give its approval to 
the IBC membership. 
It should be emphasized that 
employment of an IBC member solely 
for purposes of membership on the IBC 
does not itself make the member an 
institutionally affiliated member for 
purposes of Section IV-D-2-a. 
Except for the unaffiliated members, a 
member of an IBC for an institution not 
otherwise covered by the Guidelines 
may participate in the review and 
approval of a project in which the 
member has a direct financial interest, 
so long as the member has not been and 
does not expect to be engaged in the 
project. Section IV-D-2-d is modified to 
that extent for purposes. of these 
institutions. 
VI-C. (Deleted) 
VI-D. Certification of Host-Vector 
Systems. A host-vector system may be 
proposed for certification by the 
Director, NIH, in accordance with the 
procedures set forth in Section II-D-2-a. 
Institutions not otherwise covered by 
the Guidelines will not be subject to 
Section II-D-3 by complying with these 
procedures. 
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 VI-F-1 will be 
issued only after consultation with the 
institution as to the content of the 
notice. 
VI-E. Requests for Exceptions, 
Exemptions, Approvals. Requests for 
exceptions from prohibitions, 
exemptions, or other approvals required 
by the Guidelines should be requested 
by following the procedures set forth in 
the appropriate sections in Parts I-IV of 
the Guidelines. 
In order to ensure protection for 
proprietary data, any public notice 
regarding a request for an exception, 
exemption, or other approval which is 
designated by the institution as 
proprietary under Section VI-F-1 will be 
issued only after consultation with the 
institution as to the content of the 
notice. 
VI-F. Protection of Proprietary Data. 
In general, the Freedom of Information 
Act requires Federal agencies to make 
their records available to the public 
upon request. However, this requirement 
does not apply to, among other things, 
“trade secrets and commercial and 
financial information obtained from a 
person and privileged or confidential.” 
18 U.S.C. 1905, in turn makes it a crime 
for an officer or employee of the United 
States or any Federal department or 
agency to publish, divulge, disclose, or 
make known “in any manner or to any 
extent not authorized by law any 
information coming to him in the course 
of his employment or official duties or 
by reason of any examination or 
investigation made by, or return, report 
or record made to or filed with, such 
department or agency or officer or 
employee thereof, which information 
concerns or relates to the trade secrets, 
[or processes * * * of any person, firm, 
partnership, corporation, or 
association." This provision applies to 
all employees of the Federal 
Government, including special 
Government employees. Members of the 
Recombinant DNA Advisory Committee 
are “special Government employees.” 
VI-F-1. In submitting information to 
NIH for purposes of complying 
voluntarily with the Guidelines, an 
institution may designate those items of 
information which the institution 
believes constitute trade secrets or 
privileged or confidential commercial or 
financial information. 
VI-F-2. If NIH receives a request 
under the Freedom of Information Act 
for information so designated, NIH. will 
promptly contact the institution to 
secure its views as to whether the 
information (or some portion) should be 
released. 
VI-F-3. If the NIH decides to release 
this information (or some portion) in 
response to a Freedom of Information 
request or otherwise, the institution will 
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