23 
The Commission shall periodically review the regulations and pro- 
mulgate such amendments as it determines necessary. Upon the pro- 
mulgation of a proposed regulation, that would be more stringent than 
an existing final regulation, the Commission must provide notice to 
each State and political subdivision which has been granted an exempt 
requirement. During the review and comment period for a proposed 
regulation, the Commission will determine the effect of the regulation 
on each exempt requirement. If the Commission finds that such regu- 
lation, when final, would supersede any exempt requirement, the 
Commission will provide notice to each State and political subdivision 
which has an exempt requirement. 
The Commission shall provide notice by sending, in writing and 
through certified mail — 
(i) a copy of the proposed or final regulation ; 
(ii) a statement that such proposed or final regulations may 
supersede the exempt requirement of the State or political 
subdivision ; 
(iii) a letter, signed by the Chairman of the Commission, in- 
forming the state or political subdivision that the Commission has 
made the determination, required by subparagraph (B), and the 
effect of such determination on the exempt requirement of such 
State or political subdivision; 
(iv) a time schedule of when the proposed or final regulation 
would become effective. 
Within two years from the enactment of the Recombinant DNA 
Safety Regulation Act, and updated on an annual basis thereafter, the 
Commission, in coordination and consultation with and after review 
by the National Commission for the Protection of Human Subjects 
of Biomedical and Behavioral Research, shall prepare and transmit to 
the Congress a comprehensive study that identifies the basic ethical 
and scientific principles which should underlie the conduct, applica- 
tions, and use of recombinant DNA activities which shall include : 
(1) an analysis and evaluation of scientific and technological 
advances in past, present, and projected recombinant DNA activi- 
ties in the United States and other countries ; 
(2) an analysis and evaluation of the implication of the appli- 
cation of such advances, both for individuals and for society ; 
(3) an analysis and evaluation of the laws and ethical prin- 
ciples governing the use and potential application of recombinant 
DNA technology ; 
(4) an analysis of the exemptions given State and political sub- 
divisions of States from Federal preemption, including an analy- 
sis of the reasons therefor ; 
(5) an analysis and evaluation of the implications of recombi- 
nant DNA activities within the field of genetic engineering; 
(6) an analysis of the advantages and disadvantages of ap- 
proaches for assuring the safe and most appropriate applica- 
tions and uses of recombinant DNA with regard to the protection 
of researchers, workers, the general public, and the environment ; 
(7) any proposals for changes in the definition of recombi- 
nant DNA, as defined in section 1821(a) (2), which would lead to 
greater protection of researchers, the public, and the environment 
or would further the purposes of the Recombinant DNA Safety 
Regulation Act, and its recommendations with regard thereto ; 
[ 763 ] 
