10 
available against industry; therefore, industry will fail to 
comply. 9/ (2) The currrent regulatory structure lacks environ- 
mental expertise. (3) It lacks control over the manufacturing 
process or the product prior to marketing. 
As we demonstrate below, the criticisms leveled at the 
current scheme's ability to regulate the fermentation process, 
however, are unpersuasive. 
a . The Guidelines Are Applicable to Industry 
EPA's claim that insufficient regulatory safeguards exist 
to cover genetic engineering in an industrial context is 
incorrect. The NIH Guidelines for Research Involving Recombi- 
nant DNA Molecules K)/ contain provisions specifically applic- 
able to industrial techniques and potential industrial abuses. 
For example, an appendix in the Guidelines is dedicated to 
physical containment of large-scale (greater than 10 liters 
9/ EPA is concerned that large-scale production by inexperi- 
enced companies will increase the "risk of accidents or 
mistakes that could lead to inadvertent release of genomes 
and exposure of workers, consumers, the public and the 
environment" EPA Position Paper at 10. It is particularly 
concerned because it believes that genetic engineering 
firms "do not have the experience of established drug 
companies in the use of containment procedures." Id. at 
11 . 
10/ These guidelines were first developed in 1976 (41 Fed. 
Reg. 27902), and have undergone several revisions. The 
latest revision was published on June 1, 1983 (43 Fed. Reg 
24556). [hereinafter referred to as the Guidelines] 
[ 710 ] 
