17 August 2009

[Federal Register: August 17, 2009 (Volume 74, Number 157)]
[Notices]               
[Page 41431-41432]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17au09-79]                         

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OFFICE OF SCIENCE AND TECHNOLOGY POLICY

DEPARTMENT OF HOMELAND SECURITY

ENVIRONMENTAL PROTECTION AGENCY

[Docket No. EPA-HQ-ORD-2009-0331; FRL-8939-6]

 
Availability of Draft ``Planning Guidance for Recovery Following 
Biological Incidents''

AGENCIES: White House Office of Science and Technology Policy (OSTP), 
U.S. Department of Homeland Security (DHS) and the U.S. Environmental 
Protection Agency (EPA).

ACTION: Notice of availability.

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SUMMARY: The Homeland Security Act of 2002 (Pub. L. 107-296 Section 
301) directs the U.S. Department of Homeland Security, in partnership 
with other federal agencies, to develop and implement countermeasures 
to prepare for and respond to chemical, biological, radiological and 
nuclear threats. The White House Office of Science and Technology 
Policy (OSTP), U.S. Department of Homeland Security (DHS) and the U.S. 
Environmental Protection Agency (EPA) are issuing a draft guidance 
document entitled ``Planning Guidance for Recovery Following Biological 
Incidents'' for federal, state, local, and tribal decision makers who 
may find it useful in planning and responding to a biological incident.
    This draft Guidance describes a general risk management framework 
for government and nongovernmental decision-makers, at all levels, in 
planning and executing activities required for response and recovery 
from a biological incident in a domestic, civilian setting. The 
objective of this guidance is to provide federal, state, local, and 
tribal decision makers with uniform federal guidance to protect the 
public, emergency responders, and surrounding environments and to 
ensure that local and federal first responders can prepare for an 
incident involving biological contamination. This draft Guidance is not 
intended to impact site cleanups occurring under other statutory 
authorities such as EPA's Superfund Program, or other federal and state 
clean-up programs.
    This draft guidance is provided for immediate use, and will be 
revised as needed based on comments received and changes in regulation 
and emergency response guidance. The draft guidance is available at: 
http://www.regulations.gov. (Docket no. EPA-HQ-ORD-2009-0331).

DATES: Comments must be received by November 16, 2009.

FOR FURTHER INFORMATION CONTACT: Mr. Brendan Doyle, Senior Policy 
Advisor, National Homeland Security Research Center, Office of Research 
and Development, U.S. Environmental Protection Agency (MC: 8801R), 1200 
Pennsylvania Avenue, NW., Washington, DC 20460, Telephone: 202 564-4584 
or doyle.brendan@epa.gov.

SUPPLEMENTARY INFORMATION:

Background

    The Homeland Security Act of 2002 (Pub. L. 107-296, as amended) 
directs DHS, in partnership with other federal agencies, to develop and 
implement countermeasures to prepare for and respond to chemical, 
biological, radiological, and nuclear threats. Homeland Security 
Presidential Directive--10: Biodefense for the 21st Century describes 
the interagency activity required to meet this charge.
    This draft Planning Guidance was developed by the Biological 
Decontamination Standards Working Group (an interagency working group) 
of the White House National Science and Technology Council (NSTC) 
Subcommittee on Decontamination Standards and Technology (SDST). The 
SDST was tasked by the NSTC to develop risk management guidance for 
recovery from an incident involving biological contamination in a 
domestic, civilian setting. The interagency workgroup included 
participants from the Departments of Homeland Security, Agriculture, 
Commerce, Defense, Energy, Labor, Health and Human Services and 
Transportation and the Environmental Protection Agency. This draft 
guidance describes a general risk management framework for government

[[Page 41432]]

and nongovernmental decision-makers, at all levels, in planning and 
executing activities required for response and recovery from a 
biological incident in a domestic, civilian setting. The objective of 
this guidance is to provide federal, state, local, and tribal decision 
makers with uniform federal guidance to protect the public, emergency 
responders, and surrounding environments and to ensure that local and 
federal first responders can prepare for an incident involving 
biological contamination.
    This document follows principles developed within the context of 
Planning Guidance for Protection and Recovery Following Radiological 
Dispersal Device (RDD) and Improvised Nuclear Device (IND) Incidents--
which was published by the U.S. Department of Homeland Security (DHS) 
on August 1, 2008. The RDD/IND document introduced the overarching 
concept of optimization. Optimization is a flexible, multi-attribute 
decision process that seeks to weigh many factors. Optimization 
analyses are qualitative and quantitative assessments applied at each 
stage of decision-making process from evaluation of decontamination 
options to implementation of the chosen alternative.
    The subject draft guidance applies to characterization, 
decontamination, clearance, and potential reoccupancy of a variety of 
public facilities, drinking water infrastructure, and open areas. 
Principal topics include the unique characteristics and hazards of 
biological agents, a risk management framework for responding to a 
biological incident, and implications for remediation activities. A 
process is provided for making timely and effective decisions despite 
incomplete data and uncertainties associated with potential risks posed 
by biological agents. This decision process includes all actions 
required during response to a biological incident beginning with 
notification, screening, and environmental sampling. Each step in the 
decision-making process is described, and the various actions are 
explicitly linked to numbered boxes in a five-page decision-tree 
flowchart.
    An important step in the decision process is setting clearance (or 
cleanup) goals for determining whether a remediation is successful and 
how the treated area may be used. No formula is available for setting 
clearance goals for biological agents. The collective, professional 
judgment of experts, considered within the context of the concerns of a 
broad range of local, regional, and federal stakeholders should be used 
to set a clearance goal appropriate to the site-specific circumstances. 
A practical clearance goal is to reduce residual risk to levels 
acceptable by employing an optimization process. The aim of such a 
process is to reduce exposure levels as low as is reasonable while 
considering potential future land uses, technical feasibility, costs 
and cost effectiveness, and public acceptability. After the remediation 
is carried out, a clearance decision is made based on a judgment 
whether the decontamination verification criteria and the clearance 
goals have been met. This judgment is based on a thorough analysis of 
all sampling, processes, and other pertinent data.
    This draft document focuses on the decision making framework in 
response to a biological event. It is designed to be consistent with 
the National Response Framework (Department of Homeland Security, 
January 2008) and our scientific understanding of the characteristics 
of biological agents. Neither of these areas is static. We expect both 
our response planning and our scientific understanding of the 
characteristics of biological agents to evolve over time.

Response to Comments

    Comments will be reviewed by the White House National Science and 
Technology Council before this guidance is republished.

Availability of the Draft Guidance

    Copies of the draft guidance are available for review through 
http://www.regulations.gov, Docket number: EPA-HQ-ORD-2009-0331.

    Dated: July 27, 2009.
James Kohlenberger,
Chief of Staff, Office of Science and Technology Policy, Executive 
Office of the President.
Bradley I. Buswell,
Undersecretary for Science and Technology (Acting), U.S. Department of 
Homeland Security.
Lek G. Kadeli,
Acting Assistant Administrator for Research and Development, U.S. 
Environmental Protection Agency.
[FR Doc. E9-19688 Filed 8-14-09; 8:45 am]

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