planned as of the date of enactment of this Act, is 
likely to provide sufficient capacity for the needs of 
Government biodefense and infectious disease re-
search; 
(2) how laboratory capacity and lessons learned 
can be best shared across the biodefense and infec-
tious disease research communities, domestically and 
internationally; 
(3) whether guidance on laboratory infrastruc-
ture, commissioning, operation, and maintenance of 
such laboratories is adequate, and if such guidance 
is found to be inadequate, how to improve and 
streamline such guidance; and 
(4) ways to improve and streamline the training 
of the personnel of such laboratories, including rec-
ommendations regarding the minimum standards for 
laboratory biosafety and biosecurity training under 
section 202. 
(d) REPORT TO CONGRESS.—Not later than 240 days 
after the date of enactment of this Act, the Secretary of 
Health and Human Services shall submit to Congress a 
report on the findings and recommendations from the 
evaluation under this section. 
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SEC. 202. IMPROVEMENT OF TRAINING FOR LABORATORY 
PERSONNEL. 
(a) DEFINITION.—For purposes of this section, the 
term ‘‘high containment biological laboratory’’ means a 
laboratory that has Biosafety Level 3 or Biosafety Level 
4 facilities, as defined by the Secretary of Health and 
Human Services and the Secretary of Agriculture. 
(b) DEVELOPMENT OF MINIMUM STANDARDS.—The 
Secretary of Health and Human Services, acting through 
the Director of the Centers for Disease Control and Pre-
vention and the Director of the National Institutes of 
Health, and in coordination with the Secretary of Agri-
culture and scientific experts representing appropriate 
professional groups and international health organiza-
tions, shall develop minimum standards for laboratory bio-
safety and biosecurity training for relevant personnel of 
high containment biological laboratories. In developing 
such standards, the Secretary of Health and Human Serv-
ices shall consider existing laboratory guidelines and train-
ing modules. 
(c) REQUIREMENT FOR APPROVAL.—A person may 
not register with the Secretary of Health and Human 
Services or the Secretary of Agriculture for the possession, 
use, or transfer of listed agents in accordance with section 
351A of the Public Health Service Act (42 U.S.C. 262a) 
and section 212 of the Agricultural Bioterrorism Protec-
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tion Act of 2002 (7 U.S.C. 8401) unless the person pro-
vides to its appropriate personnel biosafety and biosecurity 
training that meets the minimum standards under sub-
section (b) in addition to any other requirements deter-
mined appropriate by the Secretary of Health and Human 
Services or the Secretary of Agriculture. 
(d) DISSEMINATION.—The Secretary of Health and 
Human Services, in coordination with the Secretary of Ag-
riculture, may disseminate the minimum standards under 
subsection (b) for voluntary use, such as when use is not 
required under subsection (b), in laboratories and aca-
demic programs in the United States and in other coun-
tries. 
SEC. 203. BIOLOGICAL LABORATORY INCIDENT REPORTING 
SYSTEM. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services, in coordination with the Secretary of Ag-
riculture, (referred to in this section as the ‘‘Secretaries’’) 
shall establish an integrated Biological Laboratory Inci-
dent Reporting System through which personnel of biologi-
cal laboratories may voluntarily report biosafety or bio-
security incidents of concern and the Secretaries may 
identify trends in such incidents and protocols for bio-
safety or biosecurity improvements. In developing such re-
porting system, the Secretaries shall consider options for 
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integrating existing voluntary and required reporting 
mechanisms. 
(b) FUNCTIONS.—In implementing the reporting sys-
tem under subsection (a), the Secretaries shall enter into 
a contract with a public or private entity that does not 
regulate biological laboratories to administer the reporting 
system. Such entity shall— 
(1) receive and process incident reports; 
(2) analyze, interpret incident data, and iden-
tify incident trends; 
(3) issue alert messages within an appropriate 
time period; 
(4) disseminate reports and other appropriate 
information, which shall not include facility-specific 
information; 
(5) not have authority to direct corrective ac-
tion or to initiate enforcement action; 
(6) ensure anonymity of individuals reporting to 
the system, to the extent permitted by law; and 
(7) conduct other activities as requested by the 
Secretaries. 
Æ 
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