CONGRESSIONAL RECORD — SENATE 
S 13315 
j August 2, 1977 
In the functions of the committee. At least 
one member of a committee shall represent 
the Interests of ronprofessionals engaged In 
recombinant DNA activities and one shall 
represent a local public health authority 
within the jurisdiction of the committee; 
ar.d there shall be two nonvoting members, 
one of whom shall represent a local govern- 
ment within such Jurisdiction, and one shall 
be representative of the interests of a com- 
munity within such Jurisdiction At least 
one-lhlrd of the voting members of any 
committee shall be Individuals who are not 
employees of. and who do not have a finan- 
cial interest In, any applicant for a license 
under section 475. 
! •'(2) The Secretary may require a com- 
mittee to use a biological safety officer to 
carry out the monitoring and Inspection 
functions of the committee with respect to 
recombinant DNA activities described in .sub- 
paragraphs (A) and (B) of section 475(a) 
(4). Such an officer shall have such public 
health, microbiological, and other apropri- 
ate training as the Secretary shall prescribe. 
"INSPECTIONS 
"Sec. 477. (a)(1) For purposes of enforce- 
ment of the licensing requirements of this 
part and the requirements of section 472 ap- 
plicable to facilities. Individuals (Including 
employees and agents of local biohazards 
committees) designated as inspectors by the 
Secretary, upon presenting appropriate cre- 
dentials and a written notice to the owner, 
operator, or agent In charge and after clearly 
Informing him of thetr authority, are au- 
thorized to enter and Inspect any facility in 
a State In which a recombinant DNA activity 
Is being conducted or In the case of Individu- 
als conducting an Inspection for a local bio- 
hazards committee, any facility under the 
Jurisdiction of such committee In which a 
recombinant DNA activity is being con- 
ducted. A separate notice shall be given for 
each such Inspection, but a separate notice 
shall not be required for each entry made 
during the period covered by the Inspection. 
Such an Inspection (A) shall be made during 
the normal business hours of the facility be- 
ing Inspected and In a reasonable manner, 
and (B) rnay extend to relevant equipment, 
materials, containers, records, flies, papers, 
processes, controls, facilities, and all other 
things in the facility bearing on whether the 
recombinant DNA activity Is being conducted 
In accordance with the licensing require- 
ments of this part or the applicable requlre- 
I ments of section 472. 
“(2) Upon completion of any Inspection of 
a facility authorized by paragraph (l) and 
prior to leaving the facility, the Individual 
making the Inspection shall give to the 
owner, operator, or agent in charge a pre- 
liminary report which summarizes any con- 
dition or practice observed by such indl-. 
vldual which. In hts Judgment. Indicates a 
violation of the licensing requirements of 
this part. He shall also prepare a written 
i final report of h!s findings and send It to 
such owner, operator, or agent within thirty 
days of the completion of the Inspection. 
"(b)(1) For purposes of enforcement of 
the requirements prescribed by or under 
sections 472 and 474. Individuals (Including 
employees and agents of local btohazards 
committees) designated as inspectors by the 
Secretary, upon presenting appropriate cre- 
dentials to the owner, operator, or agent (If 
any of these be present) In charge of — 
“(A) a vehicle or other conveyance which 
may be used In the transportation of recom- 
binant DNA and In which the Inspector has 
reasonable grounds to believe that recom- 
binant DNA ts present, or 
"(B) any real property which Is not sub- 
ject to Inspection under subsection (a) and 
tn which the Inspector has reasonable 
grounds to believe recombinant DNA Is 
present. 
and after clearly informing him of their 
authority under this paragraph, may enter 
such conveyance or real property at reason- 
able times, and Inspect, at reasonable times 
and in a reasonable manner, such convey- 
ance or real property and all things in that 
conveyance or real property which he has 
reasonable grounds to believe bear on 
whether a recombinant DNA activity Is being 
conducted In accordance with the applicable 
requirements of section 472 or 474. 
“(2) Upon completion of any inspection 
of a conveyance or real property authorized 
by paragraph (1) and prior to leaving It, the 
Individual making the inspection shall give 
to the owner, operator, or agent In charge 
a preliminary report which summarizes an^ 
condition or practice observed by such In- 
dividual which, in his Judgment, Indicates a 
violation of the requirements of section 472 
or '474. He shall also prepare a written final 
report of hLs findings and send it to such, 
owner, operator, or agent within tlilrty days 
of the completion of the Inspection. 
"(c) At the request of an Inspector con- 
ducting an inspection under subsection (a) 
or (b) of a facility, conveyance, or real prop- 
erty, the person In charge of such facility, 
conveyance, or property shall provide such 
samples of — 
"(1) recombinant DNA In such facility, 
conveyance, or property, or 
"(2) materials used In or produced by any 
recombinant DNA activity conducted In 
such facility or property, as the Inspector 
may require to determine If the applicable 
requirements of sections 472, 474, and 475 
are being complied with. 
"(d) If during an Inspection of a facility, 
conveyance, or real property conducted un- 
der subsection (a) or (b), recombinant DNA 
or any material used In or produced by a 
recombinant DNA activity which the Inspec- 
tor making the Inspection has reason to 
believe presents a significant risk to health 
or the environment is found in such facility, 
conveyance, or property, such Inspector may 
order the recombinant DNA or material de- 
tained (In accordance with regulations pro- 
mulgated by the Secretary) for a reasonable 
period which may not exceed twenty days 
unless the Secretary determines that a pe- 
riod of detention greater than twenty days 
Is required to Institute an action under sec- 
tion 479(b), In which case the Secretary may 
authorize a detention period of not to ex- 
ceed an additional thirty days. Any recom- 
binant DNA or material subject to a deten- 
tion order issued under this subsection shall 
not be moved by any person from the place 
at which It Is ordered detained until — 
“(1) released by the Secretary, or 
"(2) the expiration of the detention pe- 
riod applicable to such order, 
whichever occurs first. 
"(e) No Individual deslgnatd by the Sec- 
retary to conduct an Inspection under sub- 
section (a) or (b) shall be required to ob- 
tain a search or Inspection warrant from 
any Judical officer before entering any fa- 
cility, conveyance, or real property to con- 
duct such Inspection. 
“(f) No Individual who Is engaged In or 
has a direct financial Interest In any recom- 
binant DNA activity may be designated by 
the Secretary to conduct an Inspection un- 
der subsection (a) of the facility In which 
such activity Is being conducted, and no 
Individual who Is engaged In or has a di- 
rect financial Interest In any recombinant 
DNA activity subject to regulation under 
section 472 or 474 may be designated by the 
Secretary to conduct an inspection under 
subsection (b) with respec^ to the activity 
In which he Is engaged. 
"PROHIBITED ACTS AND PENALTIES 
"Sec. 478. (a) No person tnay violate the 
provisions of this part or any\ regulation pro- 
mulgated under this part. 
“(b)(1) Any person who violates subsec- 
tion (a) may have their license revoked, sus- 
pended, or limited by the Secretary In ac- 
cordance with section 475(d). 
"(c) Any person who knowingly or will- 
fully violates subsection (a) shall be sub- 
ject, upon conviction, to a fine of not more 
than £2.000. Each day a violation of subsec- 
tion (a) continues shall constitute a sepa- 
rate violation for purposes of this subsec- 
tion. 
"(d) For a period of time to be deter- 
mined by the court, no grant, contract, 
or other form of financial assistance for 
any purpose related to recombinant DNA 
may be provided under this Act to any per- 
son convicted under subsection (c) of a 
violation of subsection (a). 
“injunction authority; emergency 
procedure 
“Sec. 479. (a) The district courts of the 
United States shall have Jurisdiction over 
civil actions to restrain any violation of 
section 478 (a). Such a civil action may be 
brought In the United States district court 
for the Judicial district wherein any act. 
omission, or transaction constituting a vio- 
lation of section 478 (a) occurred or wherein 
the defendant Is found or transacts business. 
In any such civil action, process may be 
served on a defendant In any Judicial district 
in which the defendant resides or may be 
found. Subpenas requiring attendance of 
witnesses In any such action may be served 
In any Judicial district. 
“(b) The district courts of the United 
States shall have Jurisdiction over any civil 
action brought (1) for the seizure or de- 
struction of any recombinant DNA, or any 
material used In or produced by a recombi- 
nant DNA activity, which recombinant DNA 
or material presents or may present a sig- 
nificant risk of health or the environment 
or (2) for other appropriate relief to prevent 
its production or movement. Such civil ac- 
tion shall be brought In the district court 
of the United States within the Jurisdiction 
In which such recombinant DNA or material 
Is found. 
“disclosure of data 
"Sec. 480. (a) (1) Any Information report- 
ed to. or otherwise obtained by, the Secre- 
tary (or any representative of the Secretary) 
or any local biohazards committee under 
this part, which Is exempt from disclosure 
pursuant to subsection (a) of section 552 
of title 5. United States Code, by reason of 
subsection (b) (4) of such section, shall not 
be disclosed, except that such Information — 
"(A) shall be disclosed by the Secretary 
to any officer or employee of the United 
States — 
"(1) In connection with the official duties 
of such officer or employee under any law for 
the protection of health or the environment, 
or 
"(11) for specific law enforcement pur- 
poses; 
"(B) shall be disclosed by the Secretary If 
the Secretary determines it necessary to pro- 
tect health or the environment against an 
unreasonable risk of Injury: or 
"(C) may be disclosed by the Secretary 
• when relevant In any proceeding under this 
part, except that disclosure In such a pro- 
ceeding shall be made In such manner as to 
preserve confidentiality to the extent prac- 
ticable without Impairing the proceeding. 
A research hypothesis, design, or protocol 
shall, for purposes of this paragraph, be con- 
sidered to be Information which Is exempt 
from disclosure pursuant to subsection (a) 
of setclon 552 of title 5, United States Code, 
by reason of subsection (b) (4) of such sec- 
tion. 
“(2) In any proceeding under subsection 
(a) of section 552 of title 5, United States 
Code, to obtain Information the disclosure 
of which has been denied because of the pro- 
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