Ch. 11— Regulation of Genetic Engineering • 219 
ployed by the drug industry. \ arious members 
e.xpressed concern in the March and June 1980 
meetings about the Committee’s continuance to 
make recommendations on the applications 
without a firm knowledge of large-scale produc- 
tion. 
Second, the pro\ isions in part \ I of the Guide- 
lines, which allow prior re\ iew of submitted in- 
formation by the DHHS Freedom of Information 
.Act Officer, gi\ e an industrial applicant the op- 
tion of withholding potentially important infor- 
mation on the grounds of trade secrecy, e\en 
when DHHS disagrees. Third, because some 
R AC members ha\ e been opposed to discussing 
industrial applications in closed session (needed 
to protect proprietary information), they have 
chosen not to participate in those sessions. 
Thus, some di\ersity of opinion and e.xpertise 
has been lost. Fourth, monitoring for compli- 
ance after the scale-up applications are granted 
is limited. Some early applications were granted 
on the condition that \1H could inspect facili- 
ties, and at least one inspection was made. 
Under procedures adopted at the September 
1980 meeting, a company’s IBC will be responsi- 
ble for determining whether the facilities meet 
the standards for the large-scale containment 
level assigned by R.AC. A working group of RAC 
may visit the companies and their IBCs from 
time-to-time but only for information gathering 
purposes, rather than for regulatory actions. 
Fifth, even if noncompliance were found, no 
penalties can be imposed. 
The members of R.AC, acutely aware of the 
problems with voluntary compliance by indus- 
try, ha\e been deliberating about them for 
almost 2 years. At a meeting in May 1979, they 
decided, by a vote of nine to six with six absten- 
tions, to support the principle of mandatory 
compliance with the Guidelines by non-MH 
funded institutions. However, the Secretary of 
HEW' (Joseph Califano) decided to continue with 
the dex elopment of \ oluntary compliance provi- 
sions^® which were adopted as Part \'I of the 
Guidelines in January 1980. Actual RAC review 
of submissions from the private sector for large- 
scale work began in September 1979. At a meet- 
ing in June 1980, RAC debated the effectiveness 
“R.AC minutes of Sept. 6-7, 1979, p. 16, in Recombinant DXA Re- 
search, vol. 5, (Wash., D.C.: HEW, 1980), p. 165. 
of NlH’s quasi-regulation of industry. A primary 
concern was whether the RAC would be viewed 
as gix'ing a “stamp of approval” to industrial pro- 
jects, when, in fact, it has neither the authority 
nor the ability to do so. One member, lawyer 
Patricia King, stated:^* 
Voluntary compliance is the worst of all possi- 
ble worlds . . . .You achieve none of the objec- 
ti\es of regulation and none of the benefits of 
being unregulated. All you’re saying is 'I give a 
stamp of approval to what 1 see here before me 
without any authority to do anything.’ 
Most of the speakers expressed the desire that 
the \ arious agencies in the Interagency Commit- 
tee be responsible for such regulation. How- 
ever, the Interagency Committee, which has 
been studying the problem since January 1980, 
has yet to decide what it can do. Thus, many of 
its members see RAC as filling a regulatory void 
until the traditional agencies take action. 
Some regulatory agencies have begun to deal 
with specific problems within their areas of in- 
terest. The Occupational Safety and Health Ad- 
ministration will decide its regulatory policy on 
the basis of a study of potential risks to workers 
posed by the industrial use of rDNA techniques 
being conducted by the National Institute of 
Occupational Safety and Health (NIOSH). In a 
letter to the Director of NIH dated September 
24, 1980, Dr. Eula Bingham, then Assistant Sec- 
retary for Occupational Safety and Health of the 
Department of Labor, estimated this process 
would take approximately 2 years. The Environ- 
mental Protection Agency (EPA) has awarded 
several contracts and grants to assess the risks 
of intentional release of genetically engineered 
micro-organisms and plants into the environ- 
ment. And the Food and Drug Administration 
(FDA) has begun to develop policy with respect 
to products made by processes using genetically 
engineered micro-organisms. (Further details 
on agency actions are discussed in the section. 
Federal Statutes.) 
Compliance.— The primary mechanism in 
the Guidelines for enforcing compliance is local 
self -regulation, with very limited Federal over- 
^'Susan Wright, 'Recombinant DNA Policy: Controlling Large- 
Scale Processing,” Environment, vol. 22, September 1980, pp. 
29,32. 
