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U.S. Department of Energy 				POLICY
Washington, D.C.					DOE P 434.1

							Approved:  6-5-09

SUBJECT:CONDUCT AND APPROVAL OF SELECT AGENT AND TOXIN WORK AT
	   DEPARTMENT OF ENERGY SITES
	   
PURPOSE AND SCOPE

The Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 (Public Law 107-188) directs the Secretary
of Energy and the Administrator of the National Nuclear Security
Administration to expand, enhance, and intensify research
relevant to the rapid detection and identification of select
agents and toxins likely to be used in a bioterrorism attack or
other select agents and toxins that may cause a public health
emergency.

In meeting its obligations under the Public Health Security and
Bioterrorism Preparedness and Response Act, the Department of
Energy (DOE) places a high priority on occupational health,
safety and security and emergency management, as well as its
responsibility for protecting the public and environment from any
hazards resulting from these activities.

The purpose of this policy is to establish the Department’s
expectations for the establishment and operation of DOE research
laboratories utilizing select agents and toxins (as regulated by
the United States Department of Health and Human Services),
hereinafter called LABS, and to ensure future policy needs for
the operation, coordination, and oversight of these LABS.

POLICY

The Department will not authorize any biosafety level (BSL)-4
activity at LABS or allow BSL-4 operations to be conducted at DOE
facilities or on DOE sites.

The Department will not authorize any laboratory operations with
select agents and toxins including those which may be part of
classified Work for Others or similar projects (including work
involving Sensitive Compartmented Information (SCI) or  Special
Access Programs (SAPs) without the head of the DOE field element
being fully informed of the details of the operations.

The Department will oversee and approve the building and
operations of any DOE LABS.

All research activities performed by DOE or DOE contractors in
LABS will comply with all applicable DOE regulations and
directives as well as other applicable federal, state, and local
regulations.

BSL-3 labs will follow current DOE procedures and policy.  If
necessary, DOE will establish additional specific guidance to
ensure safe construction and operation of BSL-3 LABS.  Any new
construction of BSL-3 LABS must be conducted in accordance with
DOE O 413.3A Chg 1, Program and Project Management for the
Acquisition of Capital Assets, dated 7-28-06, as modified by 
Chg 1, dated 11-17-08.

DOE will develop a long-term strategy for Departmental
coordination of current and future research activity involving
select agents and toxins.  It will ensure a cooperative
relationship is developed with the United States Department of
Health and Human Services and the United States Department of
Agriculture (USDA) in their regulatory oversight of DOE select
agent and toxin activities.

DOE will ensure that any agency requesting work be responsible
for all costs incurred by DOE contractor(s) performing work for
that agency for which DOE is required to reimburse the
contractor(s). Such costs include any and all third party
liability costs incurred by the contractor and reimbursed by DOE
in accordance with the “Insurance- litigation and claims” clause
(DEAR 970.5228-1) contained in DOE’s contract with the
contractor. To the extent that DOE may incur any liabilities in
regards to the performance of the work directly, DOE will ensure
that the agency requesting the work will reimburse DOE for such
liabilities.

APPLICABILITY

This Policy applies to the development, construction, and
operation of research laboratories utilizing select agents and
toxins.

RESPONSIBILITIES

1.	The heads of the Program Secretarial Office (PSO) is
	responsible for the formal approval of the establishment of any
	new BSL-3 research laboratory intended for conducting research on
	or otherwise utilizing select agents and toxins.
	
2.	The heads of DOE field elements are responsible for ensuring
	the full implementation of this policy at the respective field
	facility.

3.	The DOE Biosurety Executive Working Group, in concert with
	the Department of Homeland Security and other federal agencies
	utilizing DOE laboratories, will be responsible for developing a
	long-term strategy for research activities involving select
	agents and toxins.

REFERENCES

	•	Public Law 91-190, National Environmental Policy Act (NEPA)
		of 1969, as amended, codified at 42 U.S.C. Sections 4321-4347
	
	•	7 CFR Part 331, “Possession, Use and Transfer of Select
		Agents and Toxins”

	•	9 CFR Part 121, “Possession, Use and Transfer of Select
		Agents and Toxins”
	
	•	42 CFR Part 72, “Interstate Shipment of Etiological Agents”
	•	42 CFR Part 73, “Select Agents and Toxins”

	•	42 CFR Part 1003, “Civil Money Penalties, Assessments and
		Exclusions”

	•	10 CFR Part 851, “Worker Safety and Health Program”,
		Appendix A, Section. 7, “Biological Safety”
	
	•	Biosafety in Microbiological and Biomedical Laboratories
		(BMBL).  5th Edition. Centers for Disease Control and Prevention

							   STEVEN CHU
							   Secretary of Energy