224 • Impacts of Applied Genetics — Micro-Organisms, Plants, and Animais 
medical research, NIH cannot be expected to act 
aggressively to fill this regulatory void. 
As a model for societal decisionmaking on 
technological risks, the system created by the 
Guidelines could serve as a valuable precedent. 
It does a reasonable job of combining substan- 
tive scientific evaluation of technical issues with 
procedural safeguards designed to accommo- 
date social values and to limit conflicts of in- 
terest. The only major criticism is that proce- 
dural safeguards and public input were not sig- 
nificant factors when the rDNA problem was 
first addressed. 
Other means of regulation 
There are three other means available for 
regulating molecular genetic techniques and 
their products— current Federal statutes, tort 
law and workmen’s compensation, and State 
and local laws. These all may be used to remedy 
some of the limitations of the Guidelines. 
Federal statutes 
The question of whether existing Federal 
statutes provide adequate regulatory authority 
first arose with respect to rDNA research. In 
March 1977, the Interagency Committee con- 
cluded that while a number of statutes* could 
provide authority to regulate specific phases of 
work with rDNA, no single one or combination 
would clearly reach all rDNA research to the ex- 
tent deemed necessary by the Committee. Fur- 
thermore, while some could be broadly inter- 
preted, the Committee believed that regulatory 
action taken on the basis of those interpreta- 
tions would be subject to legal challenge. This 
was the basis for their conclusion that specific 
legislation was needed and was one of the rea- 
sons behind the legislative effort discussed in 
app. III-A. 
With respect to commercial uses and prod- 
ucts of rDNA and other genetic techniques, a 
much more certain basis for regulation exists. 
Many of the Federal environmental, product 
safety, and public health laws are directed 
toward industrial processes and products. To a 
‘The Committee concentrated on the tollowing statutes: 1) the 
Occupational Safety and Health Act (29 U.S.C. §651 et. seq ); 2) the 
Toxic Substances Control Act (15 U.S.C. §2601 et. seq ); 3) the Haz- 
ardous Materials Transportation Act (49 U.S.C. §1801 et. seq ); and 
4) sec. 361 of the Public Health Service Act (42 U.S.C. §264). 
^^Interim Report of the Federal Interagency Committee on Recom- 
binant DNA Research. Suggested Elements for Legislation, op. cit. 
large extent, the genetic technologies will pro- 
duce chemicals, foods, and drugs— as well as 
pollutant byproducts— that will clearly come 
within the scope of these laws. 'However, there 
may be limitations in these laws and questions 
of their interpretation that may arise with re- 
spect to the manufacturing process, which 
employs large quantities of organisms, and 
when there is an intentional release of micro- 
organisms into the environment— e.g., for clean- 
ing up pollution. For a list of pertinent laws, see 
table 36.) 
The Federal Food, Drug, and Cosmetic Act 
(FFDCA) and section 351 of the Public Health 
Service Act (42 U.S.C. 262) give FDA authority 
over foods, drugs, biological products (such as 
vaccines), medical devices, and veterinary medi- 
cines. This authority will also apply to those 
products when they are made by genetic engi- 
Table 36.— Statutes That Will Be Most Applicable 
to Commercial Genetic Engineering 
1. Federal Food, Drug, and Cosmetic Act (21 U.S.C. §301 
et. seq.) 
2. Occupational Safety and Health Act (29 U.S.C. §651 et. 
seq.) 
3. Toxic Substances Control Act (15 U.S.C. §2601 et. 
seq.) 
4. Marine Protection, Research, and Sanctuaries Act (33 
U.S.C. §1401 et. seq.) 
5. Federal Water Pollution Control Act, as amended by 
the Clean Water Act of 1977 (33 U.S.C. §1251 et. seq ) 
6. The Clean Air Act (42 U.S.C. §7401 et. seq.) 
7. Hazardous Materials Transportation Act (49 U.S.C, 
§1801 et. seq.) 
8. Solid Waste Disposal Act, as amended by the 
Resource Conservation and Recovery Act of 1976 (42 
U.S.C. §6901 et. seq.) 
9. Public Health Service Act (42 U.S.C. §201 et. seq ) 
10. Federal Insecticide, Fungicide, and Rodenticide Act i7 
U.S.C. §136 et. seq.) 
SOURCE: Office of Technology Assessment 
