DEPARTMENT OF HEALTH. EDUCATION. AND WELFARE 
PUBLIC HEALTH SERVICE 
NATIONAL INSTITUTES OP HEALTH 
BETHESOA MARYLAND 20014 
May 22, 1978 
The Honorable Edward M. Kennedy 
Chairman, Subcommittee on Health 
and Scientific Research 
Committee on Human Resources 
United States Senate 
Washington, D.C. 20510 
Dear Mr. Chairman: 
I am writing in response to your letter of May 2. Enclosed are my 
responses to the series of questions on which you requested my views. 
Several of your questions center on the conduct of recombinant DNA 
research under the NIH Guidelines as compared to the conduct of this 
research in other countries. As you may know, the Federal Interagency 
Committee on Recombinant DNA Research prepared an extensive survey of 
international recombinant DNA research activities which was submitted in 
a report to the Secretary in November 1977. Many of my responses to 
your questions are based on the information contained in the report, and 
I am enclosing a copy for your review. 
To the best of my knowledge, all nations in which recombinant DNA research 
is being conducted either have adopted or expect to adopt some form of 
safety guidelines, although no nation has enacted legislation or imple- 
mented overt regulations to date. In some countries, such as Switzerland, 
the NIH guidelines are the model. In others, the United Kingdom (UK) 
guidelines are being used. In still others like France, West Germany, 
and Canada, separate guidelines similar in concept to the NIH and UK 
guidelines have been promulgated. There are variances, however, that 
permit experiments to proceed in some countries of Western Europe that 
are restricted under the current NIH Guidelines. Much of this variance 
is based on the "Case Law" approach of the United Kingdom Guidelines 
whereby standards are set for individual experiments. Under the current 
NIH Guidelines, such flexibility does not exist. As you know, we are 
completing proposed revisions to the NIH Guidelines. Several of the 
proposed revisions permit flexibility, and I describe such draft proposals 
more fully in my answers to your questions. 
[ 559 ] 
