226 • Impacts of Applied Genetics— Micro-Organisms, Plants, and Animals 
The Toxic Substances Control Act (TSCA) was 
intended by Congress to fill in the gaps in the 
other environmental laws. It authorizes EPA to 
acquire information on “chemical substances” in 
order to identify and evaluate potential hazards 
and then to regulate the production, use, distri- 
bution, and disposal of those substances. 
A “chemical substance” is defined under sec- 
tion 3(2) of this Act as “any organic or inorganic 
substance of a particular molecular identity,” in- 
cluding "any combination of such substances oc- 
curring in whole or in part as a result of a chem- 
ical reaction or occurring in nature.”* * This 
would include DNA molecules; however, it is 
unclear if the definition would encompass gene- 
tically engineered organisms. In promulgating 
its Inventory Reporting Regulations under 
TSCA on December 23, 1977, EPA took the fol- 
lowing position in response to a comment that 
commercial biological preparations such as 
yeasts, bacteria, and fungi should not be con- 
sidered chemical substances;^® 
The Administrator disagrees with this com- 
ment .... This definition [of chemical sub- 
stance] does not exclude life forms which may 
be manufactured for commercial purposes and 
nothing in the legislative history would suggest 
otherwise. 
However, in a December 9, 1977, letter re- 
sponding to a Senate inquiry, EPA Administra- 
tor Douglas M. Costle stated:®^ 
[Allthough there is a general consensus that re- 
combinant DNA molecules are “chemical sub- 
stances” within the meaning of section 3 of 
TSCA, it is not at all clear whether a host or- 
ganism containing recombined DNA molecules 
fits— or was intended to fit— that definition .... 
If such organisms are subject to TSCA on the 
grounds that they are a “combination of ... 
substances occurring in whole or in part as a 
result of a chemical reaction,” the Agency might 
logically have to include all living things in the 
definition of "chemical substance”— an inter- 
‘Substances subject solely to FFDCA or tbe Federal Insecticide, 
Fungicide, and Rodenticide Act are excluded from this definition. 
“42 F.R., 64572, 64584, Dec. 23, 1977. 
^'Letter to Adlai E. Stevenson, Chairman, Subcommittee on Sci- 
ence, Technology, and Space, U.S. Senate Committee on Com- 
merce, Science, and Transportation, in Oversight Report, Recombi- 
nant DNA Research and Its Applications, 95th Cong., 2d sess., Au- 
gust 1978, p.88. 
pretation which I am confident the Congress 
neither contemplated nor intended. 
If EPA were to take the broader interpreta- 
tion, and if that were to survive any legal chal- 
lenge, TSCA would have great potential for reg- 
ulating commercial genetic engineering by reg- 
ulating the organisms. Under section 4 of this 
Act, EPA can adopt rules requiring the testing of 
chemical substances that “may present an un- 
reasonable risk”* to health or the environment 
when existing data are insufficient to make a 
determination. Under section 5, the manu- 
facturer of a new chemical substance is re- 
quired to notify EPA 90 days before beginning 
production and to submit any test data available 
on the chemical’s health or environmental ef- 
fects. If EPA decides that the data are insuffi- 
cient for evaluating the chemical’s effects and 
that it "may present an unreasonable risk” or 
will be produced in substantial quantities, the 
chemical substance’s manufacture or use can he 
restricted or prohibited. Under section 0, EP.A 
can prohibit or regulate the manufacture or use 
of any chemical substance that "presents, oi' will 
present an unreasonable risk of injury to health 
or the environment.” 
As with the Occupational Safety and Health 
Act, the scientific evidence probably does not 
support a finding that most genetically en- 
gineered molecules or organisms present an un- 
reasonable risk. On the other hand, the stand- 
ard in section 5— may present an unreasonable 
risk— and the requirement for a premanulae- 
turing notice would permit El’A to e\aluat(* 
cases where genetically engineered mici’o-orga- 
nisms were proposed to he released into the 
environment. 
Several other environmental statutes w ill ap- 
ply, mainly with I'espect to pollutants, wastes, 
or hazardous materials.** The Marine' I’rotee- 
‘ The term 'unrea.sonahle I'i.sk " is not delineil in the sl.ilwlr 
However, the legislative histoi-y indicates that its drtcrmin.itinn in 
volves balancing the probability that harm will occur and the 
magnitude and severity ot that harm, against the cltci t ol the pro 
posed regulatory action and the a\ailahilit\ to socii4\ ol thi' bene 
fits of the substance. “ 
'“H. Kept. 94-1341. 94lh ( ong . 2d sess 1976 pp l.l t,'. 
* ‘ Two consumer protection statutes w ere considei I'd lint w i-i e 
determined to he x irlualiv inapplicable I hese v\eie the lc•del.ll 
Hazardous Substances ,\ct ( 15 t ' S I §t2litet sei| I anil the ( on 
sumer I’roduct Safety Act (15 tl.S ( §2tl5l el sei| I 
