15 
section 102(b) provides the Secretary with flexibility , for exemption 
of certain recombinant DNA activity which the Secretary finds does 
not present a significant risk to health or the environment, it is de- 
sirable to have as complete agreement as possible between the defini- 
tion of the activity to be regulated by the legislation and the definition 
eventually implemented by the Secretary as revisions of the Guide- 
lines. 
Since informal discussions with representatives of the National In- 
stitutes of Health indicate that the definition changes may not be 
implemented as presently proposed, it is important for the Congress 
to attend to such changes prior to enactment of the legislation. The 
definitions within the legislation and the definitions of the Guide- 
lines in effect at the time of enactment of the legislation sfioiild be 
consistent. If the revisions to the Guidelines are approved before the 
legislation is enacted, then the definition within the legislation should 
be examined for conformance with the definition within tfie Guide- 
lines.' If the legislation is enacted first, then the legislative history 
should show that it is the intention of the committee that the .defini- 
tion of recombinant DNA should be consistent with the definition pre- 
sented in the Guidelines ; where there are minor differences, the defini- 
tion within the NIH Guidelines should apply. 
Section 102. Extension of the Recombinant DNA Guideline $ 
H.R. 11192 provides the Secretary of Health, Education and Wel- 
fare with a great deal of flexibility in implementing the interim regu- 
lations. The committee concurs in the need for this degree of flexi- 
bility in the legislation, especially as it relates to the revision of the 
NIH Guidelines and to the exemption of those experiments which do 
not present significant risks to health or the environment. It is im- 
portant that the Guidelines continue to be revised regularly, relaxed 
or strengthened in the light of accumulated experience; furthermore, 
if and when conditions warrant, they should be abandoned. 
Concern has been expressed that the broad exemption power granted 
to the Secretary may encourage numerous individual requests for 
exemptions. The committee hopes that this situation does not occur ; 
it would seem poor administrative practice for the Secretary to be 
routinely involved with such decisions on a project-by-project basis. 
The committee amendment which changes the word “may” to 
“shall” (page 7, line 7) would require the Secretary to include in the 
proposed regulations provisions for reporting and for local assistance 
in the administration and enforcement of the regulations. The com- 
mittee expects that the “local entities” referred to in the legislation 
will usually be local biosafety or biohazard committees. The amend- 
ment would ensure input from these valuable groups. 
The committee notes with approval that, as part of the revision of 
th© NIH Guidelines, the NIH is considering substituting the term 
biosafety committee” for the term “biohazard committee” throughout 
the Guidelmes. In support of this trend towards more positive think- 
ing’ IBC s or LBC s will be referred to as “Institutional” or “Local 
Biosafety Committees” m the discussion which follows 
. The committee concurs with the Committee on Interstate and For- 
e vP 1 i? 1 ^ nu ? e 5 ce that the regulations promulgated by the Secretary 
should include guidelines respecting, membership on biosafety com- 
H. Rept. 95-1005 — 78 3 
[Appendix B — 203] 
