TESTIMONY BEFORE THE NIH DIRECTOR'S ADVISORY COMMITTEE 
on 
DRAFT REVISED GUIDELINES FOR RECOMBINANT DNA RESEARCH 
by 
NANCY PFUND 
SIERRA CLUB LOBBYIST 
1531 LI Camino Real 
Palo Alto, California 94301 
(or contact Washington office, 330 Pennslyvania Ave . SE 20003) 
15 December, 1977 
I. Introduction 
Thank you for giving me the opportunity to testify. I hope 
public hearings like these can be continued on a regular basis 
since they lend legitimacy to the decisionmaking process in this 
very important area. 
While I hope today's discussions will be insightful and worthwhile, 
I must express my disappointment at the timing and purpose of these 
hearings . 
That is, they represent too little effort, too late in the game. 
The draft guidelines have already been revised downward. Why? 
The introduction states that the Advisory Committee based its 
revisions on new data which diminuish the estimate of risk associated 
with recombinant DNA research in E . Coli K-12 systems. 
What are these data? Where are they published? Why have they 
not been widely circulated and subjected to comprehensive review by 
experts and the public alike? These data are not referenced in the 
guidelines and the references in the background document include 
unpublished articles, informal reports, letters and other information 
which have not been submitted to traditional means of scientific 
review nor to public debate. 
The fact that the NIH Advisory Committee gained access to new 
information and used it in developing the new guidelines without 
securing outside comment while decisions were being made makes a 
mockery of public participation in this process. As a result, many 
of the changes seem baffling and arbitrary even to those of us who 
are following this issue. If the NIH is committed to getting public 
input it must equip the public with the data its own Advisory Committee 
uses to justify its decisions. 
I find it ironic that while the NIH demands rigor in establishing 
proof from experimental data from its grantees, it settles for 
less in its own operation. And while intelligent evaluation of new 
information may have characterized the meetings of the Advisory Committee, 
by presenting the guidelines as a fait accompli with no indications 
of the reasoning behind the revisions, the NIH is undermining the 
principles of informed democratic decisionmaking. 
Essentially, we have no inkling as to how the committee reached 
its decisions. 
I quote one example from the background (page 10) : 
There are catagories of experiments for which the 
[Appendix A — 187] 
