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posed a health risk to humans. If as is more likely, recombinant organisms 
are used to produce food or drugs, these products could be regulated to assure 
that no harmful, or avoidable residues of recombinant organisms, or DNA 
molecules, are left in the product. 
Premarket approval and pesticide tolerances: Sections 408, 409, 505, 512, 515, 
7 06(a) 
All of the premarket approval sections of the Act require the manufacturer 
to prove the safety and effectiveness of his product and assign him the burden 
of developing safety and efficacy data. However, these provisions suffer from the 
same weakness as testing orders under TSCA : the risks of recombinant orga- 
nisms do not lend themselves to standardized testing for risks. A manufacturer 
may conduct enough safety testing to satisfy the FDCA. and not uncover a sig- 
nificant hazard because we do not know how to look for hazards. These pre- 
marketing approval sections will also have the effect of requiring complete 
reporting of products made with recombinant techniques, hut tliis reporting will 
occur too late to permit any effective technology assessment. 
Nonpremarketing approval sections: Sections 401, 406, 601 
The sections of the FDCA which do not require premarketing approval and 
safety testing provide virtually no protection against the hazards of recom- 
binant technology. These provisions leave FDA with the burden of showing that 
a recombinant organism which contaminates a food or cosmetic is injurious 
to health or avoidable. Both of these requirements will be difficult to meet with 
our limited knowledge of risks. 
Good manufacturing practices, registration of producers of drugs and devices , 
latch certification of insulin and antibiotics : Sections 505, 506, 507, 510, 
512, 515 
The FDCA has several provisions which require a drug or device producer 
to follow good manufacturing practices (GMP’s) to insure that the purity of 
drugs is maintained. These GMP’s are specified by regulation and are enforced 
by a requirement that producers register each facility where drugs and devices 
are produced. Registered facilities are subject to regular inspection and are 
required to report regularly which drugs are being produced at that facility. 
Insulin and antibiotics are subjected to the additional requirement that each 
batch be certified by FDA to insure that it meets the purity standards estab- 
lished for those drugs. The GMP, registration, reporting and certification pro- 
visions of the FDCA provide only limited regulation of recombinant technology, 
but they may provide a useful model for licensing recombinant research and 
production facilities. 
FEDERAL INSECTICIDE, FUNGICIDE AND RODENTICIDE ACT 
FIFRA establishes a regulatory structure very similar to the FDCA. It re- 
quires premarketing approval of pesticides, registration of facilities which pro- 
duce pesticides, and in addition requires certification of users of pesticides. How- 
ever, FIFRA differs from the FDCA in that approval of a pesticide includes 
consideration of environmental costs. A pesticide can only be approved if its 
use “will not generally cause unreasonable adverse effects on the environment." 
Although this standard provides for cost/benefit balancing, it does not provide 
the kind of technology assessment necessary for recombinant DNA. The Admin- 
istrator is not required to consider alternatives to a given pesticide and is 
specifically prohibited from refusing registration because a pesticide is not 
essential. 
FIFRA would cover any use of recombinant technology for pest control or to 
promote or regulate the growth of plants. Any micro-organism which imparted 
nitrogen fixating abilities to plants which do not now have that ability would 
be covered. However, FIFRA suffers from the same weaknesses as FDCA. it does 
not regulate research and development, or non-commei’cial activities, and it pre- 
sumes that studies can be conducted by an applicant for registration which 
accurately assess the hazards. 
OCCUPATIONAL SAFETY AND HEALTH ACT 
OSHA establishes national standards for substances which pose a health 
hazard to employees and requires all employers to comply with those standards 
[Appendix B — 356] 
