CONGRESSIONAL RECORD — SENATE August 2 y 1977 
S 13314 
denial and the reasons therefor and shall 
publish such reasons In the Federal Register. 
“(4) (A) A license to authorize the con- 
duct In a facility of any recombinant DNA 
activity which under the applicable physical 
containment requirements promulgated un- 
der paragraph (3) (A)(1) requires physical 
containment at the equivalent of the P-4 
level prescribed by the guidelines referred 
to In section 472 (a) (2), may only be Issued, 
amended, or renewed by the Secretary. Any 
comments of the Advisory Committee and 
the local biohazards committee with Jurls- 
dlctlon over such facility chall be published 
In the Federal Register. 
"(B) A license to authorize the conduct 
In a facility of any recombinant DNA activity 
which under the applicable physical contain- 
ment requirements promulgated under para- 
graph (3) (A)(1) requires physical contain- 
ment at the equivalent of the P-3 level pre- 
scribed by the guidelines referred to In sec- 
tion 472 (a) (2), may be Issued, amended, and 
renewed by a local biohazards committee in 
acoordance with this subparagraph. If the 
committee proposes to approve an applica- 
tion for the Issuance, amendment, or re- 
newal of such a license, such committee 6hall 
submit to the Secretary — 
"(1) the application for such action to- 
gether with any materials submitted to the 
committee respecting the application, and 
"(11) a statement of any conditions pro- 
posed to be Imposed by the committee on the 
approval of the application to assure that re- 
quirements under this part applicable to re- 
combinant DNA activities which would be 
conducted under the license are complied 
with, 
and, within thirty days of the submittal of 
such application and statement, the Secre- 
tary shall review the application to deter- 
mine If its approval would be In accordance 
with the requirements of this part. The local 
biohazards committee may approve the ap- 
plication unless within the applicable review 
period the Secretary determines that It may 
not be approved. The Secretary shall, subject 
to section 480, publish In the Federal Register 
the results of any application review con- 
ducted under this subparagraph, and the 
comments of the Advisory Committee on such 
application. 
“(C) A license to authorize the conduct In 
a facility of any recombinant DNA activity 
not described In subparagraph (A) or (B) 
may be Issued, amended, and renewed by a 
local biohazards committee. Upon the issu- 
ance, amendment, or renewal of a license by 
a local biohazards committee, such commit- 
tee shall submit to the Secretary (1) the ap- 
plication for such action together with any 
materials submitted to the committee re- 
specting the application, and (11) a state- 
ment of any conditions Imposed by the com- 
mittee on the approval of the application to 
assure compliance with requirements under 
this part applicable to recombinant DNA ac- 
tivities which are to be conducted under the 
license. 
"(D) If the holder of a license under this 
section proposes — 
"(1) to conduct a recombinant DNA ac- 
tivity which is not authorized by such li- 
cense. such activity may not be conducted 
under such license before It Is amended to 
authorize such activity; or 
“(11) to alter or expand a facility licensed 
by such license, no recombinant DNA ac- 
tivity may be conducted In such facility be- 
fore the license Is amended to cover such 
facility as so altered or expanded. 
The Secretary shall prescribe procedures, as 
appropriate, for the expeditious handling of 
applications for amendments of licenses. 
•■'(E) If the Secretary determines that the 
Issuance, amendment, or renewal of a license 
by a local biohazards committee under sub- 
paragraph (B) or (C) was not in accordance 
with the requirements of this part, or was 
not In the best interests of the public, the 
Secretary may take such action with respect 
to the license as he determines is necessary. 
Including revoking, suspending, or limiting 
the license. 
••(F) The Issuance, amendment, and re- 
newal of a single license to authorize the 
conduct of any combination of recombinant 
DNA activities described in subparagraphs 
(A). (B) , and (C) shall be carried out Jointly 
by the Secretary and the local biohazards 
committee involved In accordance with 
guidelines prescribed by the Secretary. 
“(b) Any Individual or public or private 
entity may apply for the issuance of a license 
under this section, and the holder of a license 
may apply for Its amendment or renewal. 
An application for the Issuance or renewal 
or a license shall be made In such form and 
manner as the Secretary shall prescribe and 
shall contain — 
"(1) a description of each recombinant 
DNA activity to be conducted under the li- 
cense (Including applicable research hypo- 
theses, designs, and protocols). Identification 
of the primary professional personnel to be 
engaged In each such activity and their qual- 
ifications, and a description of the faculties 
and materials to be used in each such 
activity; 
“(2) assurances satisfactory to the Issuer 
of the license that each recombinant DNA 
activity to be conducted under the license 
will be conducted in accordance with appli- 
cable physical and biological containment re- 
quirements prescribed under subsection 
(a) (3) (A) (1); 
“(3) assurances satisfactory to the Issuer 
of the license that In that conduct of each 
such activity there will be compliance with 
applicable personnel safety requirements 
prescribed under subsection (a) (3 (A) (11) ; 
"(4) asssurances satisfactory to the Issuer 
of the license that the holder of the license 
shall make such reports, and shall maintain 
such records, respecting each such activity 
(Including reports, and records of any sig- 
nificant or recurring Illness, serious Injury, 
or death of any personnel engaged In such 
activity and of the health care provided such 
personnel while engaged In such activity) as 
are required under subsection (a)(3)(A) 
(HI): 
“(5) a statement of the results of any 
evaluation made by or known to the appli- 
cant of the risks to health or the environ- 
ment which may be presented by any recom- 
binant DNA activity to be conducted under 
the license; and 
"(6) such additional information as the 
Secretary may prescribe. 
Applications for the amendment of a license 
shall contain the Information required by the 
preceding sentence as the Secretary deter- 
mines Is necessary. 
“(c) A license Issued under this section 
shall be valid for such period (but not In 
excess of thirty-six months) as the Secretary 
may prescribe. Such a license shall contain 
such terms and conditions as the Secretary 
finds are necessary and appropriate to carry 
out the requirements of this section and shall 
Identify each recombinant DNA activity 
which may be conducted under the license 
and the facility In which it Is to be con- 
ducted. 
"(d) The Secretary may revoke, suspend, 
or limit a license If he finds, after reason- 
able notice and opportunity for a hearing to 
the holder of the license, that the holder 
of tha license, any employee or agent of the 
holder, or any person engaged In a recom- 
binant DNA activity In such facility— 
“(1) misrepresented any material fact In 
obtaining the license, 
“(2) has engaged In or attempted to en- 
gage- in, or represented himself as entitled to 
perform, any recombinant DNA activity not 
authorized by the license. 
“(3) has failed to comply with any of the 
terms or conditions of the license. 
“(4) has failed to comply with a request 
of the Secretary for any Information or ma- 
terials the Secretary finds necessary to de- 
termine the continued eligibility for the 
license or to evaluate the possible effects on 
health or the environment of the recom- 
binant DNA activities conducted in the 
facility. 
“(5) has failed to comply with a request of 
the Secretary to Inspect any portion of the 
facility. Its operations, or Its records, which 
are related to recombinant DNA activities, 
or 
"(6) has violated or aided and abetted In 
the violation of any requirement established 
under this part. 
“(e) The Secretary ehall, within one year 
after the regulations Initially promulgated 
under subsection (a) (3) take effect, prepare 
a summary of the recombinant DNA activ- 
ities authorized to be conducted under li- 
censes Issued under this section and shall, 
subject to section 480, make such summary 
available for Inspection by the public at rea- 
sonable times and places. Such summary 
shall be kept current by the Secretary. 
“LOCAL BIOHAZARDS COMMITTEES 
“Sec. 476. (a) No facility may be licensed 
under section 475 unless a local biohazards 
committee has been established in accord- 
ance with this section with Jurisdiction over 
such facility. The Secretary shall prescribe 
the number and type of facilities which may 
be within the Jurisdiction of a single local 
biohazards committee. 
"(b) Each local biohazards committee 
(hereinafter In this section referred to as 
a ‘committee’) shall be established and op- 
erate In the manner prescribed by this sec- 
tion and regulations of the Secretary under 
this section. 8uch regulations shall be Ini- 
tially promulgated within one hundred and 
eighty days of the date of the enactment 
of this part, and shall provide that a com- 
mittee may not exercise the functions pre- 
scribed by subsection (c) unless the Secre- 
tary has authorized its establishment for 
purposes of this part. 
“(c)(1) Each committee shall have the 
authority prescribed by section 475 with re- 
spect to the Issuance, amendment, and re- 
newal of licenses under that section. A com- 
mittee shall receive and consider license ap- 
plications in accordance with such proce- 
dures as the Secretary shall prescribe. A com- 
mittee may not 'approve an application for 
the Issuance, amendment, or renewal of a li- 
cense unless at least three-fourths of the 
members of the committee vote to approve 
the application. Upon the WTltten request of 
any member of a committee for review by 
the Secretary of any decision of the commit- 
tee respecting the Issuance, amendment, or 
renewal of a license, the Secretary shall con- 
duct such review and report the results of 
this review to the committee. Such a de- 
tailed statement of the reasons for request- 
ing review by the Secretary. 
"(2) A committee shall, with respect to a 
facility licensed under section 475, be re- 
sponsible for such Inspections (In accord- 
ance with section 477) and monitoring ac- 
tivities as the Secretary may require to as- 
sure that the recombinant DNA activities 
conducted In such facility are conducted In 
accordance with the requirements of this 
part and of the license of the facility. No 
person who is a member of a committee and 
who is engaged In or has a financial interest 
In any recombinant DNA activity, may par- 
ticipate in any function of the committee 
with respect to such activity. 
"(d)(1) Each committee shall have hot 
less than seven or more than thirteen voting 
members. The members of a committee shall 
be Individuals who by virtue of their train- 
ing or experience are qualified to participate 
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