34482 
Federal Register / Vol. 46. No. 126 / Wednesday, July 1. 1981 / Notices 
recombinant molecule is used to transform 
nonpermissive cells (i.e., cells which do not 
produce infectious virus particles], this is not 
a requirement. 
(i) 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 encapsulated 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 ^e 
functional anatomy of the vector be known — 
that is, there should 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 by 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. 
(46] A USDA permit is 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-conjugated plasmit 
vectors are also poorly mobilizable (e.g., pBR 
322, pBR 313). 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 commerical 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 
institutional Biosafety Committee (IBC) 
and, where it finds the IBC meets ^e 
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 members 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 commerial 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 of any Federal department or 
agency to publish, divulge, disclose, or 
make known “in any manner or to any 
extent not authorial 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 of filed with, such 
department or agency or officer or 
employee thereof, which infdrmation , 
concerns or relates to the trade secrets, I 
[or processes. . . of any person, firm, 
partnership, corporation, or 
association.” This provision applies to 
all employees of the Federal 
Government, including Special | 
Government employees. Member of the , 
Recombinant DNA Advisory Committee [ 
are “special Government employees.” j 
Vl-F-1. In submitting information to . 
NIH for purposes of complying ^ ! 
voluntarily with the Guidelines; an | 
institution may designate those items of i 
information which the institution j 
believes constitutes trade secrets or ^ 
privileged or confidential commerical 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 reviews 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 v 
be advised and the actual release will 
not be made imtil the expiration of 15 , 
days after the institution is so advised, ;,| 
except to the extent that earlier release, 
in the judgement of the Director, NIH, is n 
necessary to protect against an 
