August 2, 1977 CONGRESSIONAL RECORD — SENATE 
S 13313 
‘recombinant DNA activities’. The term ’pub- 
lic entity’ Includes any Federal, State, oV 
local governmental entity. 
•’(5) Tire term ’Secretary’ means the Secre- 
tary ot Health, Education and Welfare. 
"INTERIM CONTROL 
’’Sec. 472. (a)(1) During the period be- 
ginning on the tenth day after the date of 
the enactment of this part and ending 
■'(A) eighteen months after such date, or 
“(B) on the date the regulations required 
by section 475 take effect, 
whichever occurs first, all recombinant DNA 
activities shall be carried out In accordance 
wtth the physical and biological containment 
requirements described In paragraph (2) . 
"(2) The physical and biological contain- 
ment requirements referred to In paragraph 
(1) are the physical and biological contain- 
ment requirements — 
“(A) as contained In the recombinant 
DNA research guidelines of the Department 
of Health. Education and Welfare published 
in part XI of the Federal Register for July 7, 
1970. 
“(B) If revised between July 7. 1976, and 
the tenth day after the date of the enact- 
ment of this part, as so revised, or 
“(C) If revised under subsection (c), as so 
revised. 
"(3) Before the expiration of the ten-day 
period beginning on the date of the enact- 
ment of this part, the Secretary shall take 
such action as niAy be necessary to publicize 
»Dd make available the requirements de- 
scribed In paragraph (2), Including the pub- 
lication of such requirements in the Federal 
Register. 
“(b) From the date of the enactment of 
this part until the expiration of the period 
described In subsection (a), all the require- 
ments of the recombinant DNA research 
guidelines of the Department of 'Health, Edu- 
cation, and Welfare — • 
“(1) as published In part II of the Federal 
Register for July 7. 1976, 
“(2) If revised between July 7, 1976. and 
the tenth day after the date of the enact- 
ment of this part, as so revised, or 
“(3) If revised under subsection (c). as so 
revised, shall continue to apply as specified 
In such guidelines. 
“(c) The phj-slcal and biological contain- 
ment requirements of the guidelines de- 
scribed In subsection (a) which are In effect 
on the tenth day after the date of the en- 
actment- of this part may be revised only by 
regulations promulgated by the Secretary In 
accordance with section 553 of title 5. United 
States Code. 
“(d)(1) Each Individual or entity which, 
on the date of the enactment of this part. Is 
responsible for the conduct of any recombi- 
nant DNA activity shall. In accordance with 
regulations promulgated under subsection 
(e) and before the expiration of ninety days 
from the date of the enactment of this part, 
report In writing to the Secretary — 
“(A) such Individual's or entity's name, 
and 
“(B) a description of such activity and an 
identification of the place or places In which 
It Is being conducted 
“(2) Each Individual or entity which Is to 
be responsible for a recombinant DNA ac- 
tivity to be commenced during the period 
described In subsection (a) shall upon the 
commencement of such activity report in 
writing to the Secretary such individual’s or 
entity's name, a description of such activity, 
and an identification of the place or places 
In Which such activity Is to he conducted. 
“(e) Before the expiration of the forty-five 
day period beginning on the date of the 
enactment of this part, the Secretary shall, 
without regard to subsections (c) and (d) 
of section 553 of ttlle 5. United States Code, 
promulgate such regulations as may be nec- 
essary for the administration of the require- 
ments of this section. 
“(f) The regulations described in this sec- 
tion and In section 476 may be promulgated 
without regard to section 102(2) (C) of the 
National Environmental Policy Act of 1969. 
“GENERAL REQUIREMENTS 
“Sec. 473. (a) Except as provided under 
subsection (b), the following requirements 
apply under this part with respect to recom- 
binant DNA activities: 
“(1) Each facility In which a recombinant 
DNA activity Is to be conducted shall be 
licensed In accordance with section 475. 
“(2) The transportation of recombinant 
DNA and any other recombinant DNA ac- 
tivity (Including an agricultural activity) 
which Is not conducted in a facility shall be 
carried out in accordance with regulations 
promulgated by the Secretary under section 
474. 
“(b) The Secretary may, by regulation, 
exempt from the requirements of this part 
any recombinant DNA activity which the 
Secretary finds does not present a significant 
risk to health or the environment. 
“CONTROL OF NONFACILITY RECOMBINANT 
DNA ACTIVITIES 
“Sec. 474. (a) The Secretary shall promul- 
gate regulations to control the conduct of 
recombinant DNA activities described In sec- 
tion 473(a)(2). Such regulations shall — 
“(1) prescribe physical and biological con- 
tainment requirements for the conduct of 
such activities: 
“(2) apply as appropriate, to the conduct 
of such activities, the personnel safety re- 
quirements prescribed under section 475; 
“(3) Include such special requirements as 
the Secretary determines necessary for the 
conduct of recombinant DNA activities In- 
volving more than ten liters of cell cultures 
containing recombinant DNA and for the 
conduct of any fommercial recombinant 
DNA activity which the Secretary deter- 
mines may present a significant risk to 
health or the environment; and 
“(4) Include such other provisions as the 
Secretary determines to be necessary for the 
protection of health or the environment. 
“(b) The Secretary shall consult with the 
Advisory Committee respecting the promul- 
gation of the regulations required by subsec- 
tion (a) (including the promulgation of 
amendments to such regulations other than 
amendments to make clerical or technical 
changes) , and any notice of proposed rule- 
making issued by the Secretary respecting 
such regulations shall contain any com- 
ments submitted respecting such regulations. 
“(c) The regulations required by subsec- 
tion (a) shall be initially promulgated-wlth- 
ln one year of the date of the enactment of 
this part and shall take effect upon the ex- 
piration of one hundred and eighty-days from 
the date of their promulgation. 
“(d) The Secretary shall provide for an 
annual review of the regulations required by 
subsection (a) to determine If their require- 
ments continue to protect health and the 
environment. 
“(e) If the Secretary receives a petition 
for the promulgation of a regulation to pre- 
scribe an additional requirement under sub- 
section (a) or to revise or repeal a require- 
ment contained in a regulation promulgated 
under that subsection, the Secretary shall 
either approve or deny the petition within 
one hundred and twenty days after the date 
the petition Is received by the Secretary. If 
the Secretary approves such a petition, the 
Secretary shall, as soon as practicable after 
the date the petition Is atjproved. commence 
a proceeding as requested by the petition. If 
the Secretary denies such a petition, he shall 
notify the petitioner of the denial and the 
reasons therefor ar.d shall publish such rea- 
sons In the Federal Register. 
“LICENSES 
“Sec. 475. (a)(1) Licenses for facilities 
in which recombinant DNA activities are to 
be conducted shall be Issued, amended, and 
renewed in accordance with this section. 
“(2) A license under this section Is the 
authority for the conduct of recombinant 
DNA activities in the facility or facilities for 
which the license Is Issued. The Secretary 
shall prescribe guidelines respecting — 
“(A) the types and number of facilities 
that may be covered by a single license, and 
“(B) the types of recombinant DNA activi- 
ties that may be authorized by a single 
license. 
"(3) (A) The Secretary shall promulgate 
regulations to Implement the administration 
of this section. Such regulations shall — 
“(1) prescribe physical and biological con- 
tainment for recombinant DNA activities au- 
thorized to be conducted under licensee Is- 
sued under this section; 
“(11) prescribe requirements for — 
“(I) laboratory safety training to be given 
to, and safety techniques to be followed by, 
personnel to be Involved In such activities. 
“ (II) monitoring sys terns to protect against 
accidental exposure and other hazards to the 
health of such personnel while engaged In 
such activities, 
“(III) the type and form of Information 
to tb given sucK personnel concerning the 
nature of the health risks presented b7 such 
activities and the frequency and manner of 
giving them such Information, and 
"(IV) the type and frequency of medical 
examinations to be given such personnel 
w r hlle engaged In such activities; 
“(111) prescribe requirements respecting re- 
ports to be made and records to be main- 
tained by the holders of licenses Issued under 
this section; 
"(iv) Include such special requirements as 
the Secretary determines necessary for the 
conduct of recombinant DNA activities In- 
volving more than ten liters of cell cultures 
containing recombinant DNA and for the 
conduct of any commercial recombinant DNA 
activity which the Secretary determines may 
present a significant risk to health or the 
environment; and 
“(v) Include such other provisions as the 
Secretary determines necessary for the ef- 
fective administration of the requirements 
of this section. 
“(B) Regulations required . by subpara- 
graph (A) shall be Initially promulgated 
within one year of the date of the enactment 
of this part and shall take effect upon the 
expiration of one hundred and eighty days 
from the date of their promulgation. 
“(C) The Secretary shall consult with the 
Advisory Committee respecting the promul- 
gation of the regulations required by sub- 
paragraph (A) (including the promulgation 
of amendments to such regulations other 
than amendments to make clerical or techni- 
cal changes), and any notice of proposed 
rulemaking Issued by the Secretary respect- 
ing such regulations shall contain any com- 
ments submitted to the Secretary by the Ad- 
visory Committee respecting such regula- 
tions. 
"(D) The Secretary shall provide for an 
annual review of the regulations required by 
subparagraph (A) to determine if their re- 
quirements continue to protect the public 
health and safety and the environment. 
“(E) If the Secretary receives a petition 
for the promulgation of a regulation to pre- 
scribe an additional requirement under sub- 
paragraph (A) or to revise or repeal a re- 
quirement contained in a regulation promul- 
gated under that subparagraph, the Secre- 
tary shall either approve or deny the petition 
within one hundred and twenty days after 
the date the petition Is received by the Secre- 
tary. If the Secreta'ry approves such a peti- 
tion. the Secretary shall, as soon as practica- 
ble after the date the petition is approved, 
commence a proceeding as requested by the 
petition. If the Secretary denies such a peti- 
tion, he shall notify the petitioner of the 
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