218 • Impacts of Applied Genetics — Micro-Organisms, Plants, and Animals 
tions, respectively.* DOD no longer claims an 
exception for national security. NSF took its 
position when it approved funding for an ex- 
periment using a particular species of yeast that 
had not been certified by NIH, relying on an am- 
biguously worded section’® in the Guidelines to 
assert that it could certify the host. Subsequent 
revisions explicitly stated that these hosts had to 
be certified by the Director of NIH”" and 
removed many similar ambiguities. 
In the final analysis, NIH has indirect leverage 
over the actions of other agencies through its 
funding. All non-NIH funded rDNA projects at 
an institution which also receives NIH funds for 
rDNA work must comply with the Guidelines; 
otherwise NIH funds may be suspended or ter- 
minated. 
While the procedures of other agencies for 
administering compliance are significantly less 
formal than those created by the Guidelines for 
NIH, they do rely heavily on NIH for help and 
advice, and they coordinate their efforts 
through the Interagency Committee and their 
nonvoting membership on RAC. So far, this vol- 
untary compliance by the agencies appears to 
be working fairly well. 
The most significant limitation in the scope of 
the Guidelines is their nonapplicability to in- 
dustrial research or production on other than a 
voluntary basis. This lack of legal authority 
raises concerns not only about compliance but 
also about NIH’s ability to implement a volun- 
tary program effectively. 
Whether every company working with rDNA 
will view voluntary compliance to be in its best 
interest depends on a number of factors. In 
the past, certain short-sighted actions by even a 
few companies in a given industry has led to 
*For a statement of the DOD position, see the minutes of the 
November 23, 1976, meeting of the Federal Interagency Commit- 
tee. At that time, DOD had no active or planned rDNA projects. 
NSF’s statement of its intention to "preserve some level of inde- 
pendence of decision" was expressed in an internal NIH memo- 
randum dated February 24, 1978, from the Deputy Director for 
Science, NIH, to the Director, NIH. 
'®Dr. John H. Moxley, III., Assistant Secretary of Defense for 
Health Affairs, personal communication, Nov. 18, 1980, 
''"Fungal or Similar Lower Eukaryotic Host- Vector Systems," 41 
F.R. 27902, 27920, July 7, 1976. 
'^43 F.R. 60108, Dec. 22, 1978, sec. IIl-C-5 of the 1978 Guidelines. 
■MS F.R. 6724, Jan. 29, 1980, sec. III-C-5 of the 1980 Guidelines. 
well-documented abuses and a host of Federal 
laws to curtail them. However, at least two con- 
straints are operating in the case of the bio- 
technology industry. First, the possibility of tort 
lawsuits is an inducement to comply with the 
Guidelines, which would probably be accepted 
as the standard of care against which alleged 
negligence would be evaluated. (This concept is 
discussed in greater detail in the section on Tort 
Law and Workman’s Compensation.) Second, 
the threat of statutory regulation, which the 
companies have sought to avoid, always exists. 
Other factors are also at work. Except for the 
10-1 limitation, for which case>by-case excep- 
tions must be sought, the large-scale contain- 
ment recommendations of April 11, 1980, are 
not excessively burdensome, at least for phar- 
maceutical companies. The requirements are 
similar to measures that must currently he 
taken to prevent product contamination. In ad- 
dition, the public debate should have made each 
company aware of the problems and the need 
for voluntary compliance before it inv ested sub- 
stantially in biotechnology; expensive controls 
will not have to be retrofitted. However, one 
definite concern is that new com|)anies at- 
tracted to the field will perceive their interests 
differently. Because they did not actually expe- 
rience the period when legislation seemed ine\ i- 
table and because they will he late entries in th(> 
race, they may be inclined to take shortcuts. 
Besides the concern about whether iiulustry 
has sufficient incentive to comply, theri’ ar(> a 
number of other reasons for (luestioning th(> ef- 
fectiveness of the voluntary program. First, until 
very recently no member of KAt! was an e,\|)ert 
in industrial fermentation technology— yet the 
Committee has been considering applications 
from industry for large-scale production since 
September 1979.* This drawback was demon- 
strated at its March 1980 meeting, when the 
Committee expressed uncertainty owr what 
Federal or State safety regulations [iresently 
cover standard fermentation technolog^v I’ln- 
‘At its September 1980 meeting. R \( p.issed the InllmMiig res 
oliUion, wliieb hits been accepted b\ the Du et tnr ol \IM ” 
\teml)ci‘.s should he chosen to pi'oude expei lise in lei inent.ilinn 
lechnologv, (engineering, .ini 1 oilier ,is|iec1s i it l.n ge si .ile jn inIih In >n 
A termentation lechnnlng\ expert w.is appointed m l.iim.iix 
1981. 
'M.l F.R. 77373, Nov. 21, Iil8l) 
