9 
> 
2-Year cost projections — H.R. 11192 Recombinant DNA Act 
[Dollars In millions] 
Number of positions in HEW. 
Projected cost, Title I 
Projected cost, Title II 
1979 
1980 
50 
75 
$3.0 
$4.5 
.5 
.5 
These projections are based upon the current 200 laboratories now 
using recombinant DNA techniques, and the 300 projected by the end 
of fiscal year 1978. This number is expected to grow significantly in 
the near future. 
The required staff positions include those involved in developing 
and conducting training programs for the approximately 1,500 scien- 
tists and technicians soon to be involved in recombinant DNA re- 
search, to handle paperwork involved with the registration of activ- 
ities, and to assist the Secretary and the NIH Recombinant Advisory 
Committee in carrying out its duties to develop and review safety 
standards and then respond to inquiries from the scientific community 
regarding interpretation of the regulations and from the public re- 
garding the safety and usefulness of recombinant DNA activities, 
and for inspectors and other general support staff. 
The estimated cost of the study commission is listed separately. 
SECTION-BY-SECTION SUMMARY OF H.R. 1119 2 
Title I — Interim Regulation of Recombinant DNA Activities 
Definitions ( section 101 ) 
Section 101 of the bill defines the term “recombinant DNA” ex- 
plicitly and operationally as it is done in current NIH Guidelines. 
“Recombinant DNA activity” is defined as the possession in a State 
of recombinant DNA and any activity (including research and trans- 
portation) undertaken for the production of recombinant DNA. 
Extension of the recombinant DNA guidelines ( section 102) 
Section 102(a) of the bill provides for the extension of the require- 
ments of sections II (Containment) and III (Experimental Guide- 
lines) of the NIH Guidelines to all recombinant DNA activities be- 
ginning on the tenth day after the date of enactment and ending 
twenty four months after such day. Before the expiration of the ten- 
day period the Secretary of HEW is required to publicize and make 
available the requirements of sections II and III of the Guidelines. 
The Secretary is authorized to amend the requirements, in accord- 
ance with the Administrative Procedure Act, if he determines that 
such an amended requirement would be sufficient for the protection 
of health and the environment. 
Section 102(b) authorizes the Secretary to exempt from the re- 
quirements any recombinant DNA activity which he finds does not 
present a significant risk to health or the environment. 
Section 102(c) requires each individual or entity which is responsi- 
ble for the conduct of any recombinant DNA activity or which will 
be responsible for such an activity to be commenced during the period 
the guidelines are in effect to report to the Secretary such individual’s 
or entity’s name, a description of such activity, an identification of 
the place or places in which such activity is or will be conducted, and 
[Appendix B — 139] 
