232 • Impacts of Applied Genetics— Micro-Organisms, Plants, and Animals 
or conflicting provisions of the Guidelines for 
revision, 5) identifying emerging trends or prob- 
lems, and 6) tracing any long-term adverse im- 
pacts on health or the environment back to 
their sources. 
The obvious disadvantages of this option are 
the increased paperwork and effort by scien- 
tists, universities, corporations, and the Federal 
Government. Those working with rDNA would 
have to gather the required information peri- 
odically and prepare reports, which would be 
filed by the sponsoring institution with a 
designated existing Federal agency. A wide- 
range of information would be required for 
each project. The agency would have to process 
the reports and take other actions, such as pre- 
paring an annual report to Congress, to imple- 
ment the underlying purposes of this option. 
Additional manpower would most likely be 
needed by that agency. 
A statute implementing this option could in- 
clude the following elements: 1) periodic collec- 
tion of information in the form of reports from 
all institutions in the United States that sponsor 
any work with rDNA, 2) active evaluation of 
that information by the collecting agency, 3) an- 
nual reports to Congress, and 4) a sunset clause. 
Important information would include: 1) the 
sponsoring institution's name; 2) all places 
where it sponsors the research; and 3) a tabular 
or other summary that discloses for each proj- 
ect continuing or completed during the report- 
ing period: the culture volume, the source and 
identity of the DNA and the host-vector system, 
the containment levels, and other information 
deemed necessary to effect the purposes of the 
act. The statute could also require employers to 
institute and report on a worker health sur- 
veillance program. 
For this option to work, the monitoring agen- 
cy would have to take an active role in eval- 
uating the data. It should have the authority to 
require amendments to the reports when any 
part is vague, incomplete, or inconsistent with 
another part. It could also be required to notify 
the appropriate Federal funding agency of ap- 
parent cases of noncompliance with the Guide- 
lines by their grantees. Finally, it should pre- 
pare an annual report to Congress on the effec- 
tiveness of Federal oversight. 
The choice of an agency to administer the 
statute would be important. The selection of 
NIH would permit the use of an existing admin- 
istrative structure and body of expertise and ex- 
perience. On the other hand, one of the regu- 
latory agencies may take a more active moni- 
toring role and be more experienced with 
handling proprietary information. 
This approach is similar to a bill introduced in 
the 96th Congress, S. 2234, but broader in 
scope. The latter covered only institutions not 
funded by NIH, and did not contain provisions 
for requiring amendment's to the reports oi- foi- 
notifying other agencies of possible noncom- 
pliance. The bill was broader in one respect 
because it would have required information 
about prospective experiments. This provision 
had been criticized because of the difficulty of 
projecting in advance the course that scientific 
inquiry will take. The goals of a monitoring pro- 
gram can be substantially reached by monitor- 
ing ongoing and completed work. 
D. Congress could make the NIH Guidelines ap- 
plicable to all rDNA work done in the United 
States. 
The purpose of this option is to allev iate any 
concerns about the effectiveness of voluntary 
compliance. RAC itself has gone on record as 
supporting mandatory compliance with the 
Guidelines by non-NIH funded instituions, in- 
cluding private companies. 
This option has the advantages of using an e,\- 
isting oversight mechanism, which would sim- 
ply be extended to industry and to academic re- 
search funded by agencies other than Nlll. Spe- 
cific requirements on technical (|uestiotis such 
as containment levels, host-vector .systems, and 
laboratory practices would continue to he .set by 
NIH in order to accommodate new information 
expeditiously; the statute would simply codilv 
the responsibilities and proctKlui’es of the cur- 
rent system. There would he few transitional 
administrative problems, since tin* e\p«*rtise 
and experience already exist at NIH However, it 
would be necessary to appoint .several experts 
