Ch. 11— Regulation of Genetic Engineering • 225 
neering methods. However, interpreti\e ques- 
tions ai'ising out of the unique nature of the 
technologies— such as the type of data nec- 
essary to show the safety and efficacy of a new 
drug produced by rDNA techniques— will have 
to be resoKed by the administrative process on 
a case-by-case basis. 
FU.A has not published any statements of of- 
ficial policy toward products made by genetic 
engineering. Since it has different statutory au- 
thority for different types of products, it is like- 
ly that regulation u ill be on a product-by-prod- 
uct basis through the appropriate FDA bureau. 
Substances produced by genetic engineering 
will generally be treated as analogous products 
produced by conventional techniques with re- 
spect to standards for chemistry, pharmacolo- 
g\', and clinical protocols; howe\ er, quality con- 
trols may have to be modified to assure continu- 
ous control of product purity and identity. In 
addition, for the time being, the Bureau of 
Drugs and the Bureau of Biologies will require a 
new IMotice of Claimed Investigational Exemp- 
tion for a New Drug and a new New Drug Appli- 
cation for products made by rDN,A technology, 
e\en if identity with the natural substance or 
with a previously appro\ ed drug is shown. This 
policy is based on the position that drugs or 
biologies made by rDN,A techniques have not 
become generally recognized by experts as safe 
and effective and therefore meet the statutory 
definition of a "new drug. 
FFDCA also permits regulation of drug, food, 
and device manufacturing. Certain FDA regula- 
tions, called Good Manufacturing Practices, are 
designed to assure the quality of these products. 
FDA may have to revise these to accommodate 
genetic technologies; it has the authority to do 
so. It probably does not have the authority to 
use these regulations to address any risks to 
workers, the public, or the enx ironment, since 
FFDCA is designed to protect the consumer of 
the regulated product. 
“Minutes of the Industrial Practices Subcommittee of the Fed- 
eral Interagency Advisory Committee on Recombinant DNA Re- 
search, Dec. 16, 1980, p. 3. 
•Sec. 201(p) of the FFDCA (21 U.S.C. §321(p)) defines a new drug 
as "anv drug . . . the composition of which is such that such drug 
is not generally recognized, among experts qualified by scientific 
training and experience ... as safe and effective 
The statute most applicable to worker health 
and safety is the Occupational Safety and Health 
Act, which grants the Secretary of Labor broad 
power to reciuire employers to provide a safe 
workplace for their employees. This power in- 
cludes the ability to require an employer to 
modify work practices and to install control 
technology'. The statute creates a general duty 
on employers to furnish their employees with a 
workplace "free from recognized hazards that 
are causing or are likely to cause death or seri- 
ous physical harm,” and it requires employers 
to comply with occupational safety and health 
standards set by the Secretary of Labor. Accord- 
ing to a recent Supreme Court case, a standard 
may be promulgated only on a determination 
that it is "reasonably necessary and appropriate 
to remedy a significant risk of material health 
impairment.”^'* Because these fairly stringent re- 
quirements limit the Act’s applicability to 
recognized hazards or significant risks, the 
statute could not be used to control manufactur- 
ing where the genetic techniques presented on- 
ly hypothetical risks. However, it should be ap- 
plicable to large-scale processes using known 
human toxins, pathogens, or their DNA. 
The Secretary of Labor is also directed to ac- 
count for the "urgency of the need” in es- 
tablishing regulatory priorities. How the De- 
partment of Labor will view genetic technol- 
ogies within its scale of priorities remains to be 
seen. NIOSH, the research organization created 
by this statute, has been studying rDNA produc- 
tion methods to determine what risks, if any, 
are being faced by workers. It has conducted 
fact-finding inspections of several manufac- 
turers, and it is planning a joint project with 
EPA to assess the adequacy of current control 
technology. In addition, a group established by 
the Center for Disease Control (CDC) together 
with NIOSH will be making recommendations 
on: 1) the medical surveillance of potentially ex- 
posed workers, 2) the central collection and 
analysis of medical data for epidemiological pur- 
poses, and 3) the establishment of an emergency 
response team.®^ 
^“Industrial Union Department, AFL-CIO v. American Petroleum 
Institute, 100 S.Ct. 2844,2863, 1980. 
’^Minutes of the Industrial Practices Subcomittee of the Federal 
Interagency Advisory Committee on Recombinant DNA Research, 
Dec. 16, 1980, op. cit., p. 6. 
