42 
U (D) For purposes of this paragraph , ‘ exempt requirement ’ means 
a requirement of a state or political subdivision which has been exempt 
under subsection ( 5 ) of section 1813. 
“(<?) Within two years from the enactment of the Recombinant 
BN A Safety Regulation Act , and updated on an annual basis there - 
after , the Commission , in coordination and consultation with and after 
review by the National Commission for the Protection of Human Sub - 
jects'of Biornedical and Behavioral Research, shall prepare and trans- 
mit to the Congress a comprehensive study that identifies the basic 
ethical and scientific principles which should underlie the conduct , 
applications , and use of recombinant BN A activities which shall 
include : 
“ (1) an analysis and evaluation of scientific and technological 
advances in past, present, and projected recombinant BN A ac- 
tivities 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 
BN A technology ; 
“ (If) an analysis of the exemptions given State and political 
subdivisions of States from Federal preemption , including an 
analysis of the reasons therefor; 
“ (5) an analysis and evaluation of the implications of recom- 
binant BN A activities within the field of genetic engineering ; 
u (6) an analysis of the advantages and disadvantages of ap- 
proaches for assuring the safest and most appropriate applica- 
tions and uses of recombinant BN A with regard to the protection 
of researchers , workers, the general public, and the environment; 
“ (7) any proposals for changes in the definition of recombinant 
BN A, 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 BN A Safety 
Regulation Act, and its recommendations with regard thereto ; 
“(8) appropriate additional recommendations for the conduct 
of recombinant BN A activities particularly with respect to the 
best approaches for assuring the safest and most appropriate ap- 
plications and uses of recombinant BN A and the appropriate role 
of assessment of risk-benefit criteria in these determinations; 
“( 9 ) a determination of the status and extent of recombinant 
BN A activities conducted in exempted areas in the United States 
and in areas outside the United States, and cm analysis of the 
nature of regulation in other countries ; 
“ (10) a summary of the Commission's decisions with respect to 
the facilities which have been licensed and the terms and condi- 
tions attached thereto; and 
11 (11) a summary of actions taken to accomplish the purposes 
of the Recombinant BN A Safety Regulation Act, the nature of 
the difficulties encountered in enforcement , the number and nature 
of penalties imposed during the preceding year and cm evaluation 
of their adequacy as deterrents to future violations, areas of re- 
combinant BN A activity outside this title which might pose a 
danger to researchers, the public or the environment, and any other 
[ 782 ] 
