44 
organisms also apply to the premanufacturing review provisions of 
the act. Nonetheless, since the commercial manufacture of new mole- 
cules, including the manufacture of new DNA molecules, requires pre- 
manufacturing review under TOSCA, some further discussion of its 
provisions is appropriate. 
Under section 5 of TOSCA, manufacturers of new chemical sub- 
stances (in this case, new DNA molecules) are required to give notice 
to EPA 90 days prior to the first manufacture of those substances- 
Significant new uses of existing substances are also covered by the same 
provision. The premanufacturing review period may be extended to 
180 days if the A dminis trator finds good cause. The premanufactur- 
ing notice must include: (a) the identity of the substance, (b) the 
proposed uses, ( c ) the amounts to be produced, ( d ) a description of 
byproducts, ( e ) employees exposed, and (/) the manner or method 
■of disposal. The results* of any tests which have been conducted on the 
substance must also accompany the submission. 
During the premanufacturing review period, the Administrator of 
EPA is authorized to halt or limit the manufacture of the new sub- 
stance or significant new use of an existing substance if the Adminis- 
trator finds an unreasonable risk of injury to health or the environ- 
ment. In addition, mechanisms exist to halt or limit the manufacture 
of the substance if the information available to the Administrator is 
insufficient to permit a reasoned evaluation of the health and environ- 
mental effects, and the Administrator makes a determination that an 
unreasonable risk exists or that there will be significant human or 
environmental exposure. 
While TOSCA provides for premanufacturing review, manufac- 
turers are free to proceed if the Administrator fails to take action 
during the premanufacturing review. There is substantial question as 
to whether this type of ‘‘catch me if you can” procedure is sufficient 
to guard against potential dangers of recombinant DNA exposure.. 
Premanufacturing review and certification by the Administrator that 
no undue risk to health or the environment exists, as is now the case- 
with pesticides and drugs, appears to be warranted. 
FIFRA requires premanufacturing approval of pesticides by EPA. 
In order to obtain approval, a manufacturer must demonstrate to the- 
Administrator that the pesticide will perform its intended function 
without unreasonable adverse effects on the environment, including 
humans. If a manufacturer is unable to demonstrate an absence of 
unreasonable adverse effect, it is the intent of this statute that registra- 
tions not be granted. While the EPA has been criticized for failing- 
adequately to screen pesticidal products prior to registration, it is 
clear that this procedure, if exercised correctly, can serve as a basis 
for eliminating undue risk to health or the environment associated 
with the pesticidal uses of recombinant DNA techniques prior to any 
manufacture, sale, or movement in commerce. A similar procedure 
exists under the FDCA with respect to food additives, color additives, 
new drugs, new animal drugs, devices, and pesticide residues. A major 
shortcoming of the FDCA is that the regulatory authority extends 
only to the protection of human and animal health, not to the protec- 
tion of the environment. 
In summary, with respect to (a) substances subject to FDCA, (b) 
pesticides, and ( c ) substances subject to section 5 of TOSCA, it is- 
[Appendix B — 303] 
