16 
assures . . . that no employee will suffer material impairment 
of health or functional capacity even if such employee has 
regular exposure to the hazard dealt with by such standard for 
the period of his working life." 2_6 / It is difficult to 
imagine a scenario in which the health and safety of the immedi- 
ately proximate workers operating a closed fermentation process 
is assured, yet the environment or the health of society at 
large is endangered. 
There exist additional controls over the manufacture of 
genetically engineered pharmaceuticals, which are subject to 
regulation both as "drugs" and as "biologies." 
(1) Section 361 of the Public Health Service 
Act authorizes the creation and 
enforcement of such regulations as "are 
necessary to prevent the introduction, 
transmission, or spread of communicable 
diseases . . . ." 2_7/ The courts have 
26 / Id . at 655(b)(5). Note that this provision arguably 
would not apply to microorganisms (although OSHA clearly 
believes that it does. See 29 C.F.R. § 1910.20 (11)). 
However, if the TSCA phrase "toxic substances" includes DNA 
or microorganism OSHA's "toxic materials or harmful 
physicial agents" certainly would as well. Also note that 
a recent Supreme Court case, Industrial Union Dept . 
AFL-CIO v. Am. Petroleum Inst. , 100 S . Ct . 2844 (1980) 
permits promulgation of standards only when "reasonably 
necessary to remedy a significant risk of health 
impairment." However, significant risk appears to be a 
less stringent requirement than that found in TSCA -- 
unreasonable risk. 
27 / 42 U.S.C. § 264 et seq . "For purposes of carrying out 
and enforcing these [regulations] the Surgeon General may 
provide for such . . . measures, as in his judgment may be 
necessary." Id . 
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