Ch.11 — Regulation of Genetic Engineering • 215 
rhe reciuirements imposed on an institution 
and its scientists are enforced l)v the authority 
of N'lH to suspend, terminate, or place other 
conditions on its funding of the offending proj- 
ects or all projects at the institution. Compliance 
is monitored through the requirements for noti- 
fication mentioned aho\ e. 
PROVISIONS FOR \()Ll\T.ARV CO.MPLI ANCE 
Organizations or indi\ iduals w ho do not re- 
cei\e any \'IH funds for rUN'.A research are not 
coxered hy the Cuidelines. These include other 
Federal agencies, institutions and indixiduals 
funded by those agencies, and corporations. 
Federal agencies other than i\'IH that conduct 
or fund rD\,\ research ha\e proclaimed their 
\oluntary compliance with the Guidelines.* 
Staff scientists ha\ e been so informed hy memo- 
randa. .As foi' outside inxestigators, this policy 
has been implemented through the grant appli- 
cation process. Instructions in grants appli- 
cations contain policy statements regarding 
compliance w ith the Guidelines, and applicants 
are sometimes contacted to ascertain their 
knowledge of the Guidelines. Information has 
been requested for certain e.xperiments, and 
IBC membership has been rex iewed. From time 
to time, the agencies haxe consulted xxith NIH 
on matters that need interpretation. 
Part \ I of the Guidelines is designed to en- 
courage xoluntary compliance by industry. It 
creates a parallel system of project reviexv and 
IBC approxal analogous to that required for 
\IH-funded projects, modified to allex iate in- 
dustry’s concerns about protection of pro- 
prietary information. 
The Freedom of Information Act requires 
Federal agencies, xxith certain exceptions, to 
make their records ax ailable to the public on re- 
quest. One of the exceptions is for trade secrets 
and proprietary information obtained from 
others. Part \'I contains sexeral provisions for 
protecting this information. Perhaps the most 
important is a process xvhereby a corporation 
•These agencies are the National Science Foundation, the De- 
partment of Agriculture, the Department of Energ\', the X eterans 
•Administration, and the Center for Disease Control. Two other 
agencies, which have e.xpressed interest in this research but are 
not currently sponsoring any projects, are the Department of De- 
fense and the National .Aeronautics and Space .Administration. 
may request a presubmission reviexv of the 
records needed to register its projects xvith NIH. 
The DHHS Freedom of Information Officer 
makes an informal determination of whether 
the records xvould haxe to he released. If they 
are determined to be releasable, the records are 
returned to the submitting company. The 
Guidelines also require that NIH consult xvith 
any institution applying for an exemption, 
exception, or other approx al about tbe content 
of any public notice to be issued xvben the ap- 
plication inx olx es proprietary information. As a 
matter of practice, such applications are also 
considered by RAC in nonpublic sessions. 
Large-scale experiments (more than 10 1 of 
culture) xvith rDNA molecules are prohibited 
unless the rDNA is "rigorously characterized 
and the absence of harmful sequences estab- 
lished.” Such experiments are actually scale-ups 
of potential industrial processes. Those meeting 
this standard may be approved by the Director 
of NIH under procedures specified by RAC.* At 
its September 1979 meeting, RAC adopted pro- 
cedures for reviexv that require the applicant to 
submit information on its laboratory practices 
and containment equipment. Subsequently, rec- 
ommendations xvere developed for large-scale 
uses of organisms containing rDNA. These were 
published in the Federal Register on April 11, 
1980. Besides setting large-scale containment 
levels, they require the institution to appoint a 
Biological Safety Officer xvith specified duties, 
and to establish a xvorker health surveillance 
program for xx^ork requiring P3 containment. At 
its September 1980 meeting, RAC modified its 
reviexv procedures so that the application need 
only specify the large-scale containment level at 
which the work xvould be done, without pro- 
viding details on containment equipment. RAC 
xvill continue to review the biological aspects of 
the applications in order to determine that 
rDNA is rigorously characterized, that the ab- 
sence of harmful sequences is established, and 
that the proposed containment is at the ap- 
propriate level. 
•It is NIH, not the company proposing the scale-up, that deter- 
mines if the rDNA to he used is "rigorously characterized and the 
absence of harmful sequences established.".'^ 
‘^Guidelines for Research Involving Recombinant DNA Mole- 
cules, sec. IX'-E-l-b-(3)-(d). 
