60104 
NOTICES 
duct of permissible experiments, and provld- 
Inc for changes In these restrictions as fur- 
ther scientific evidence resolves the uncer- 
tainties about the health and environmental 
effects of using recombinant UNA tech- 
niques. 
Evidence accumulated In the past year, 
rather than revealing any hazards associat- 
ed with these- experiments, points to a high 
level of safety In the use of the predominant 
host organism, the K-12 strain of E colt 
The NTH Recombinant DNA Molecule Pro- 
gram Advisory Committee has recommend- 
ed changes In the Institute's research guide- 
lines to reflect this evidence, and these rec- 
ommendations are being considered by Di- 
rector Fredrickson. Other hosts and vectors 
have received less scrutiny, and uncertainly 
remains about risks that may be associated 
with future applications of the technology. 
These uncertainties Justify continuing to re- 
quire certain precautions In recombinant 
DNA work. 
However, the hearings have also under- 
scored the need to correct deflclenqles In 
the present system of regulation. Privately 
supported research activities are not subject 
to monitoring by NIH nor to sanctions for 
failure to comply with the guidelines. Appli- 
cation of the NIH standards by other Feder- 
al agencies Is voluntary. As Director Fre- 
drickson has stated on several occasions. It 
la doubtful this enforcement by the princi- 
pal Federal sponsor of recombinant DNA re- 
search— NIH— la appropriate. Procedures for 
revising the standards and exempting cer- 
tain experiments should be clarified. It Is 
Important to ensure the accountability of 
institutions and Investigators, particularly If 
they are to assume greater responsibility for 
monitoring compliance. The Federal Gov- 
ernment should anticipate commercial ap- 
plications of recombinant DNA techniques 
and the concerns they arc likely to raise. 
In view of these developments and In view 
of the heavy legislative schedule of the 
Senate and the Human Resources Commit- 
tee. we are writing to Inquire whether the 
deficiencies In the present regulatory 
system can be remedied through executive 
action In the event final agreement on legis- 
lation Is not possible. Specifically. It would 
seem possible to shift monitoring and en- 
forcement responsibilities from NIH to a 
more appropriate agency within the Depart- 
ment of Health. Education, and Welfare. It 
would also seem possible to remedy the 
problems of accountability and of coverage 
in the process of revising the recombinant 
DNA guidelines. On the basis of the survey 
of existing statutory authorities conducted 
by the Committee on Commerce. Science 
and Transportation, there seems to be ade- 
quate authority to regulate the commercial 
application of products developed through 
recombinant DNA technology. There Is. 
however, need for more effective coordina- 
tion among Federal agencies in the Imple- 
mentation of these authorities. 
In this regard, you expressed to Senator 
Stevenson In your letter of February 27. 
1978. that the Food and Drug Administra- 
tion •* • * could, under existing authority, 
require any firm seeking approval of a prod- 
uct which may be the end product of recom- 
binant DNA research to certify to the 
Agency that It has compiled with the NIH 
guidelines on recombinant DNA." You 
noted also that FDA has authority to In- 
spect firms making such certification to 
assure compliance with the NIH guidelines. 
This statement Is important because most. 
FEDERAL 
if not all. recombinant DNA research by the 
private sector is being conducted by phar- 
maceutical companies with the objective of 
developing products that would be marketed 
In accordance with FDA regulations. A deci- 
sion by the Administration to use this exist- 
ing authority would bring the large major- 
ity of privately funded recombinant DNA 
research activities under the NIH guide- 
lines. Is the Administration prepared to use 
the authority cited In your February 27th 
letter? 
Finally, it has been suggested that section 
381 of the Public Health Service Act pro- 
vides sufficient authority to promulgate reg- 
ulations covering recombinant DNA re 
search conducted by the private sector with 
non-Foderal funds. Although you have ex- 
pressed the view that specific legislative au- 
thority Is preferable to us^ng the authority 
of section 361, we are. raising the Issue again 
for three reasons: tl) The need for new leg- 
islation Is less clear than H was one year ago 
when the Initial bills were Introduced. (2) 
the existing regulatory deficiencies relating 
to Federally supported research can be re- 
medied by executive action, and (3) the 
heavy legislative schedule may preclude 
action In this session of Congress. In view of 
these developments. It seems prudent to ex- 
plore the willingness of the Executive 
Branch to use the authority of section 361 
to cover privately-funded recombinant DNA 
research. In addition, we request that you 
solicit a legal opinion from the Department 
of Justice as to the use of section 361 In this 
manner. 
There Is an additional factor to consider. 
In the past. Congress has been reluctant to 
extend statutory control over a specific field 
of scientific Investigation unless such au- 
thority was absolutely necessary to protect 
the public's health and safety. In view of 
the scientific evidence accumulated during 
the past year. It Is not possible to reach this 
conclusion In the ease of recombinant DNA 
research. If the deficiencies discussed above 
could be corrected through executive 
action— by use of existing powers of FDA 
and/or the authority of section 361— there 
would be no reason to legislate new statuto- 
ry controls. 
In the event these executive actions were 
Implemented, we would recommend that an 
appropriate group of experts and lay per- 
sons. such as the advisory committee to the 
NIH Director, continue to monitor the sci- 
entific evidence relating to the hypothetical 
risks of recombinant DNA research. If evi- 
dence Indicating actual risks were to be de- 
veloped. Congress could once again consider 
the need for legislation. 
Since we are presently considering the leg- 
islative agenda for the balance of this ses- 
sion. we would appreciate your prompt re- 
sponse to this Inquiry. 
Sincerely. 
Edward M. Kennedy. 
Chairman, Subcommittee on 
Health and Scientific 
Research. 
Jacob K. Javits. 
Ranking Minority Member, 
Committee on Human Resources. 
REGISTER. VOL 43, NO. 247— FRIDAY, DECEMBER 
[27] 
Gaylord Nelson, 
Member, 
Committee on Human Resources. 
Adlai E. Stevenson. 
Chairman, Subcommittee on 
Science, 
Technology and Space. 
Harrison A. Williams. Jr., 
Chairman, 
Committee on Human Resources. 
Richard S. Schweiker. 
Ranking Minority Member, Sub- 
committee on ' Health and Sci- 
entific Research. 
The Secretary or Health. 
Education, and Weltare. 
H’ajAingfon. D.C.. September 12, 1978. 
Hon. Edward M Kennedy, 
CViafrman, Subcommtf/ce on Health and 
Scientific Research, Committee on 
Human Resources. United States Senate. 
Washington, D C. 20S10 
Dear Ted: Thank you ‘for your letter in 
which you have raised a number of thought- 
ful questions concerning the need for legis- 
lation to regulate recombinant DNA re- 
search. 
As you state In your letter, new scientific 
information, particularly on the safety of E. 
coli K-12 (the principal organism used In 
these experiments). Indicates that extensive 
regulation in this research area may be un- 
warranted. Indeed, there Is additional evi- 
dence that many recombinant DNA manipu- 
lations In the laboratory may be similar to 
events that occur in nature. 
In view of these scientific developments, 
you raise the question as to whether legisla- 
tion is necessary or whether existing statu- 
tory authority would be sufficient for pur- 
poses of regulation. You cite specifically the 
regulatory authority of the FDA and of the 
Public Health Service Act (Section 361). 
The Department does not Intend to 
Invoke existing statutory authorities to reg- 
ulate DNA activities at this time. If an 
emergency were to occur before passage of 
legislation, the Department could reconsid- 
er this position In order to lake action on an 
Interim basis. But. we continue to support 
legislation If It embodies the moderate ap- 
proach of H.R. 11192. The virtue of such 
legislation Is that It n. v include a number 
of specific provisions that permit useful 
flexibility In implementing regulations. 
Such provisions Include: 
• the promotion of uniform nalional 
standards. 
• clear authority for the Secretary In re- 
lationship to other Federal laws. 
• avoidance of normal administrative pro- 
cedures for initial application of NIH Guide- 
lines and waiver of the Administrative Pro- 
cedures Act (APA) for Issuance of adminis- 
trative regulations, and authority for the 
Secretary to waive regulatory requirements 
for activities that pose no significant risk to 
health or the environment. 
In recommending legislation, the Federal 
Interagency Committee on Recombinant 
DNA Research reviewed all existing statuto- 
ry authority and found that none could pro- 
vide for comprehensive regulation of these 
activities. The Interagency Committee 
noted that under Section 361 "there would 
presumably have to be a reasonable basis 
for concluding that the products of all re- 
22, 1978 
