Ch. 11 — Regulation of Genetic Engineering • 227 
tion, Research, and Sanctuaries Act prohibits 
ocean dumping without an EPA permit of any 
material that would “unreasonably degrade or 
endanger human health, welfare, or amenities, 
or the mai’ine en\ ironment, ecological systems, 
or economic potentialities.”^® "Material" is de- 
fined as "matter of any kind oi' description, in- 
cluding . . . biological and laboratory waste 
. . . and industrial . . . and other waste."'"’ The 
Federal Water Pollution Control .Act regulates 
the discharge of pollutants (which include bio- 
logical materials) into LfS. waters, and the Solid 
Waste Disposal ,Act regulates hazardous wastes. 
The Clean .Air .Act regulates the discharge of air 
pollutants, which includes biological materials. 
Especially applicable is section 112 (42 U.S.C^ § 
7412), w hich allows EP.A to set emission stand- 
ards for hazardous air pollutants— those for 
which standards have not been set under other 
sections of the Act and which "may reasonably 
be anticipated to result in an increase in mortali- 
ty or an increase in serious irre\ ersible, or in- 
capacitating re\ersible, illness.” The Hazardous 
Materials Transportation .Act co\ers the inter- 
state transportation of dangerous articles, in- 
cluding etiologic (disease-causing) agents. The 
Secretary of Transportation may designate as 
hazardous any material that he finds "may pose 
an unreasonable risk to health and safety or 
property” when transported in commerce in a 
particular quantity and form.^’ 
Section 361 of the Public Health Ser\ ice Act 
(42 U.S.C. §264) authorizes the Secretary of 
HEW (now DHHS) to “. . . make and enforce 
such regulations as in his judgment are neces- 
sary to pre\ ent the introduction, transmission, 
or spread of communicable diseases . . . .” Be- 
cause of the broad discretion given to tbe Sec- 
retary, it bas been argued that this section pro- 
\'ides sufficient authority to control all rDNA ac- 
tivities. * Others ha\ e argued that its purpose is 
to protect only human health; for regulations to 
be \ alid, there would have to be a supportable 
finding of a connection between rDNA and 
”33 U.S.C. § 1412. 
“33 U.S.C. § 1402(c). 
“49 U.S.C. § 1803. 
'On Nov. 11, 1976, the Natural Resources Defense Council and 
the Environmental Defense Fund petitioned the Secretary of HEW 
to promulgate regulations concerning rDNA under this Act. 
human disease. In any event, HEW declined to 
promulgate any regulations. 
The following conclusions can therefore be 
made on the applicability of existing statutes. 
First, tbe products of genetic technologies— 
such as drugs, chemicals, pesticides,** and 
foods— u'ould clearly be covered by statutes 
already covering these generic categories of 
materials. Second, uncertainty exists for regu- 
lating either production methods using en- 
gineered micro-organisms or their intentional 
release into the environment, when risk has not 
been clearly demonstrated. Third, the regu- 
latory agencies have begun to study the situa- 
tion but have not promulgated specific regu- 
lations. Fourth, since regulation will be dis- 
persed throughout several agencies, there may 
be conflicting interpretations unless active ef- 
forts are made by the Federal Interagency Com- 
mittee to develop a comprehensive, coordinated 
approach. 
Tort law and workmen's compensation 
Statutes and regulations are usually directed 
at preventing certain types of conduct. While 
tort law strives for the same goal, its primary 
purpose is to compensate injuries. (A tort is a 
civil wrong, other than breach of contract, for 
which a court awards damages or other relief.) 
By its nature, tort law is quite flexible, since it 
has been dev'eloped primarily by the courts on a 
case-by-case basis. Its basic principles can easily 
be applied to cases where injuries have been 
caused by a genetically engineered organism, 
product, or process. It therefore can be applied 
to cases involving genetic technologies as a 
means of compensating injuries and as an incen- 
tive for safety-conscious conduct. The most ap- 
plicable concepts of tort law are negligence and 
strict liability. (A related body of law— work- 
men’s compensation— is also pertinent.) 
Negligence is defined as conduct (an act or an 
omission) that involves an unreasonable risk of 
harm to another person. For the injured party 
to be compensated, he must prove in court that: 
1) the defendant’s conduct was negligent, 2) the 
••Pesticides are subject to the Federal Insecticide, Futigicide, 
and Rodenticide Act, 7 U.S.C. § 136 et. seq.. 
