research. The "direct" extension requirement is sufficiently 
vague as to make the proposed revision ineffectual in assuring 
adequately international regulation of recombinant research under 
the NIH Guidelines. 
For example, if, as was the case with the Wistar experiment, 
parties engage in the applicable research are not the parties who 
developed the recombinant material with NIH funds, those involved 
could claim that the research is not a "direct extension of the 
development process." If the deliberate release or human testing 
is separated from the development stage by a substantial period 
of time, those involved could also claim that the research is not 
a direct extension. Additionally, if the manner of deliberate 
release or human testing of recombinant material is altered from 
plans outlined in the development stage, those involved could 
claim that the research was not a direct extension of the 
development process. These foreseeable scenarios and many other 
potential circumstances demonstrate that the "direct" extension 
criteria is insufficient to carry out the purposes intended by 
the revised proposal. 
The Foundation recommends that the "direct" extension 
language of the proposed revision be deleted and the first 
sentence of the revised provision read as follows: 
The NIH Guidelines are also applicable: (1) To projects 
done abroad if they are supported by NIH funds or (2) to 
research done abroad if it involves deliberate release into 
the environment or testing in humans of materials containing 
recombinant DNA developed with NIH funds and the research is 
connected to, and/or a reasonably foreseeable extension of , 
the development process. 
The suggested language underlined is based on language in 
environmental regulation and legislation which provide guidance 
for defining and limiting the types of activities and impacts to 
be regulated in the proposed revision of I-C. 
The concept of "connected" actions has been defined by the 
Council on Environmental Quality (CEQ) in the following manner. 
Actions are connected if they "cannot or will not proceed unless 
other actions are taken previously or simultaneously" and/or "are 
interdependent parts of a larger action and depend on the larger 
action for their justification." 40 C.F.R. § 1508 .25 (a) (1) (ii) 
and (iii) . The term "reasonably foreseeable" has also been 
adequately defined in terms of cumulative impacts, including 
impacts of future actions. See 40 C.F.R. §§ 1508.7 and 1508.8. 
Because these terms have been proven to be relatively precise and 
effective tools in environmental regulation, they provide an 
adequate standard for the revision of I-C. 
2. The Foundation also recommends deletion of the sentence: 
Recombinant DNA Research, Volume 13 
[378] 
