47 
process so that these decisions are made properly. It is also implicit 
in any system for premanufacturing review that the responsibility 
for developing tests with respect to health and environmental effects 
should lie with those who will benefit economically from the 
commercialization. 
Moreover, authority should exist to order testing after premanu- 
facturing review in order to insure that health and environmental 
data is current. There have been important improvements recently 
in the design of test mechanisms for health and environmental effects 
of chemical substances and other materials. The development of rapid 
screening svstems. including the so-called Ames test, for mutagenesis 
and possible carcinogenic activity is but one indication of progress 
in hazards testing technology. The availability of testing authority 
should help insure that the latest in testing technology is used fully. 
Each agency of Government with regulatory responsibility ap- 
plicable to recombinant DXA technology and related products also 
has research authority or access to it. In addition. TOSCA contains 
authority for the EPA Administrator to require testing by manufac- 
turers and processors of chemical substances, which could include 
recombinant DXA and other derived products. The testing authority 
of TOSCA is broad and requires the Administrator to order testing 
when there is insufficient information or when a substance will be 
produced in substantial quantities. Congress intended that the pro- 
vision be broadly interpreted: the conference report accompanying 
TOSCA indicates that testing may be required whenever '•'there is a 
basis for concern." (Senate Report 94-1302. 94th Congress, second 
session, page 61.) This authority appears to be sufficient, although 
the task is complicated by the fact that it may be very difficult to 
design tests to determine potential health or ecological impacts of a 
unique new organism. 
RECORDKEEPING AND REPORTING REQUIREMENTS 
Section S(a) of TOSCA provides comprehensive authority for the 
Administrator of the EPA to require recordkeeping and the submis- 
sion of reports concerning a broad range of activities associated with 
the commercialization of chemical substances. Information that may 
be required includes the identity of the substance, categories of use 
or proposed categories of use, the amount produced, any byproducts 
resulting, existing data concerning environmental and health effects, 
human exposure, and the manner or method of disposal. The authority 
contained in section 8(a) is limited, however, by an exemption for 
small business from the general reporting requirements. As a substan- 
tial number of producers of commercial recombinant DXA could well 
fall within most definitions of “small business." the limitation of sec- 
tion 8(a) could be detrimental. 
Section 8 (c). (d). and (e) requires producers and distributors to 
maintain records of adverse reactions, to maintain lists of health and 
safety studies conducted, known, or reasonably ascertainable with 
subsequent submission upon request by EPA. and notice to the Ad- 
ministrator of substantial risks associated with substances. The small 
business reporting exemption does not applv to section 8 (c). (d), 
and (e). 
[Appendix B — 306] 
