NOTICES 
60105 
combinant DNA research cause or may 
cause human disease. Such a conclusion 
would undoubtedly be tenuous at best, and 
it is unlikely that resulting requirements 
could be effectively imposed and enforced." 
Your letter suggested that we seek a legal 
opinion from the Department of Justice on 
the use of Section 361. Justice is represent- 
ed in the Interagency Committee and has 
participated in the review and recommenda- 
tions concerning existing statutory authori- 
ties. including Section 361. 
The authorities of the Food and Drug Ad- 
ministration (FDA) were reviewed by the 
Committee; but inasmuch as recombinant 
DNA research has not yet reached the stage 
where it has yielded products to be regulat- 
ed by FDA, it was agreed that FDA prob- 
ably does not have authority to impose re- 
quirements on such research at present. 
On July 28, the Department published 
proposed revisions to the Guidelines on re- 
combinant DNA research for 60 days of 
comment. In addition, I have asked General 
Counsel Peter Libassi to serve as Chairman 
and Dr. Donald Fredrickson as Vice Chair- 
man of a September 15 public hearing on 
these proposed revisions. Analysis of written 
and oral comments will proceed as quickly 
as possible, with final issuance of the re- 
vised Guidelines expected before the first of 
December. 
A number of proposed changes in the 
Guidelines would permit, on a voluntary 
basis, registration of activities and NIH cer- 
tification of new host-vector systems from 
the private sector. Protection would be pro- 
vided for proprietary an patent information 
for these private sector activities. Registra- 
tion of recombinant DNA projects, irrespec- 
tive of source of funding, would be required 
of institutions receiving NIH support for re- 
combinant DNA research. By these means, a 
national registry of all Federal and private 
sector activities may evolve. 
The Interagency Committee has been an 
invaluable forum for developing coherent 
and coordinated policies through the repre- 
sentation of all the relevant research and 
regulatory agencies, and has served to 
ensure a commonality of standards. This 
Committee should continue to provide such 
oversight for the development of Federal 
policies and to ensure institutional compli- 
ance with the NIH Guidelines. Other advi- 
sory committees, both technical and public, 
must continue. The Recombinant DNA Ad- 
visory Committee will have a continuing 
role, and as you suggest in your letter, the 
public Advisory Committee to the Director, 
NIH, should continue to consider recom- 
mendations from the technical group. 
The NIH and the Center for Disease Con- 
trol (CDC) will continue to work closely as 
they have done over the past 18 months 
concerning safety aspects of the Guidelines. 
For example. NIH, in conjunction with 
CDC, has been developing mechanisms for 
assisting institutions in managing possible 
laboratory emergencies and for providing 
direct assistance when appropriate. Indeed. 
NIH and CDC are collaborating in a revision 
of the CDC Classification of Etiologic 
Agents on the Basis of Hazards— a classifica- 
tion that underpins some of the safety re- 
quirements of the Guidelines. Also, these 
agencies are reviewing packaging and ship- 
ping requirements relavant to recombinant 
DNA activities. 
Close cooperation and consultation with 
the Food and Drug Administration and the 
Environmental Protection Agency will also 
be essential, since the regulatory authority 
of these agencies will come into play when 
recombinant DNA research inventions are 
ready for commercial development. The Oc- 
cupational Safety and Health Administra- 
tion will exercise its regulatory authority in 
the workplace. 
We are pleased with the progress made in 
the absence of legislation and believe that 
invocation of existing authorities, however 
appropriate, would not contribute material- 
ly to our objectives. Only passage of legisla- 
tion embodying the features cited here 
W'ould, in our opinion, justify the change 
from a voluntary to a regulatory approach. 
Should the Senate choose to act, I would 
strongly urge adoption of an approach simi- 
lar to H.R. 11192. 
Sincerely, 
Joseph A. Califano, Jr. 
[FR Doc. 78-35532 Filed 12-21-78: 8:45 am) 
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FEDERAL REGISTER, VOL 43, NO. 247— FRIDAY, DECEMBER 22, 1978 
