NOTICES 
60081 
posed actions unless he determines 
that they present no significant risk to 
health or the environment. 
Guideline Coverage 
The revised guidelines apply to all 
recombinant DNA research conducted 
at any institution which receives NIH 
funds for recombinant DNA research. 
At these institutions, even research 
conducted without NIH support must 
comply with the guidelines. Other re- 
search agencies of the Federal govern- 
ment have assured us that they will 
require compliance with the NIH 
guidelines for all recombinant DNA re- 
search that they conduct or support. 
We are also taking action to assure 
that the guidelines apply, to the great- 
est extent possible, to research con- 
ducted in the private sector. 
• At my direction, the Food and 
Drug Administration is today an- 
nouncing its intent to propose than 
any recombinant DNA research sub- 
mitted to satisfy FDA’s regulatory re- 
quirements must have been conducted 
in compliance with the NIH guide- 
lines. 
• I have also written to Douglas 
Costle, the Administrator of the Envi- 
ronmental Protection Agency (EPA) 
and asked him to review EPA’s regula- 
tory authority to determine whether 
EPA can regulate recombinant DNA 
research conducted privately that is 
not submitted to the FDA. I have 
asked him to take all action he can. 
If both FDA and EPA act to regulate 
privately conducted recombinant DNA 
research, virtually all recombinant 
DNA research in this country would 
be brought under the requirements erf 
the revised guidelines. 
Broadened Committee Membership 
I will announce shortly the names of 
14 new members of HEW’s recombin- 
ant DNA Advisory Committee. In addi- 
tion to scientists who are experts in 
molecular biology and other disci- 
plines, the Committee will be expand- 
ed to include persons knowledgeable in 
a wide variety of fields such as law, 
public policy, ethics, the environment 
and public health. The Committee will 
serve as the principal advisory body to 
the Director of NIH and to the Secre- 
tary of HEW on recombinant DNA 
policy. 
Increased Risk Assessment Research 
While our knowledge about the risks 
of recombinant DNA has increased 
dramatically, much remains unknown. 
The scientific community must contin- 
ue to assess the extent of the risks 
posed by recombinant DNA research. I 
am therefore directing the Assistant 
Secretary for Health and the Director 
of the National Institutes of Health to 
formulate a plan for carrying out a 
balanced program of additional risk 
FEDERAL 
assessment experiments. In my view, 
the more risk assessment experiments 
NIH conducts or supports, the better 
we can judge whether the guidelines— 
and actions taken under them— afford 
appropriate protection for health and 
the environment. 
Today’s action represents the culmi- 
nation of a long and thorough process 
that has sought at each step to bal- 
ance the important concerns involved 
in recombinant DNA research. The 
National Institutes of Health in 1976 
published guidelines to govern re- 
search which it funds. 
The 1976 guidelines: 
• Prohibited six categories of recom- 
binant DNA experiments which ex- 
perts felt posed significant hazards. 
• Defined degrees of physical and 
biological containment necessary to 
prevent recombinant DNA organisms 
from escaping into the environment 
and surviving. 
• Described permissible categories 
of recombinant DNA research and as- 
signed levels of physical and biological 
containment for each. 
• Described specific roles and re- 
sponsibilities for principal investiga- 
tors, research institutions, institution- 
al biohazard committees, and the NIH. 
Since issuance of the 1976 guide- 
lines, recombinant DNA techniques 
have become much more widely used 
in research, and more has been 
learned about the limits of potential 
risks in using this technology. 
In light of this new knowledge, the 
Director, NIH, on July 28, 1978 pro- 
posed substantial modification and re- 
laxation of the guidelines. At that 
time, I named a Departmental review 
committee consisting of Peter Libassi, 
the Department’s General Counsel, as 
Chairperson; Dr. Donald Fredrickson, 
the Director of NIH, as Vice Chairper- 
son; Dr. Julius Richmond, Assistant 
Secretary for Health; and Dr. Henry 
Aaron, then Assistant Secretary for 
Planning and Evaluation. I asked the 
Committee to examine the proposed 
guidelines and to hold a public hearing 
on the guidelines. 
In reviewing the guidelines, the com- 
mittee solicited and heard comments 
from representatives of environmental 
groups, unions, pharmaceutical com- 
panies, institutional biosafety commit- 
tees and Congressional staff members. 
The committee reviewed more than 
170 letters from the public comment- 
ing on the revisions. The committee 
planed a vital role in the process 
which led to the revised guidelines and 
unanimously recommended that the 
revised guidelines be approved. 
These revised guidelines provide for 
a flexible, open system that can ac- 
commodate new scientific information 
that may warrant change, either to 
relax or to increase safety require- 
ments. 
REGISTER, VOL. 43, NO. 247— FRIDAY, DECEMBER 
[ 4 ] 
I applaud all who have labored to 
develop these guidelines: The scientif- 
ic community, the public, and workers 
at the Federal, State and local levels. 
This research holds promise for 
adding to our understanding about 
basic biological processes. These guide- 
lines should permit that promise to be 
realized without presenting any sig- 
nificant risk to public health or the 
environment. 
Dated: December 15, 1978. 
Joseph A. Califano, Jr., 
Secretary. 
Appendix A 
The Secretary of Health, 
Education, and Welfare. 
Washington, D.C. 20201. 
December 15 , 1978 . 
MEMORANDUM TO: Commissioner of 
Food and Drugs, Director, National In- 
stitutes of Health. 
THROUGH: Assistant Secretary for Health. 
SUBJECT: FDA Requirements for Compli- 
ance with -the NIH Guidelines far Re- 
combinant DNA Research. 
With my approval and that of the Assist- 
ant Secretary for Health, the Director of 
the National Institutes of Health is issuing 
today revised Guidelines for Recombinant 
DNA Research. 
These Guidelines set down requirements 
for all recombinant DNA research either 
conducted by NIH or conducted by institu- 
tions receiving NIH funds for recombinant 
DNA research. Other Federal agencies fund- 
ing recombinant DNA research have agreed 
to require recipients of their funds to 
comply with these Guidelines as well. 
To the maximum extent possible, we 
should extend the coverage of the NIH 
Guidelines to recombinant DNA research 
carried out in the private sector, with appro- 
priate protection for proprietary and patent 
rights. 
As we discussed, the pharmaceutical in- 
dustry does most of the recombinant DNA 
research that is carried out privately in this 
country. Accordingly, the Food and Drug 
Administration is issuing today a Notice of 
Intent to propose regulations. These pro- 
posed regulations would require that all re- 
combinant DNA research submitted to the 
PDA to satisfy the FDA’s regulatory re- 
quirements be carried out in compliance 
with the Guidelines. This requirement 
should bring under the Guidelines the vast 
majority of recombinant DNA research con- 
ducted in this country by the private sector. 
If FDA does adopt such regulations, there 
must be close cooperation between NIH and 
FDA in implementing them. With the Com- 
missioner of Food and Drug taking the lead, 
you should prepare a plan of action on the 
steps necessary to apply the Guidelines to 
the private sector. 
Please submit a memorandum describing 
your proposed plan of action at the time 
you submit proposed regulations. 
Joseph A. Califano. Jr. 
22, 1978 
