E9-19688. 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.

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(OSTP), U.S. Department of Homeland Security (DHS) and the U.S. Environmental Protection Agency (EPA) are issuing a draft guidance document entitled “Planning Guidance for Recovery Following Biological Incidents” for federal, state, local, and tribal decision makers who may find it useful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This draft Guidance describes a general risk management framework for government and nongovernmental decision-makers, at all levels, in planning and executing activities required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 This draft Guidance is not intended to impact site cleanups occurring under other statutory authorities such as EPA's Superfund Program, or other federal and state clean-up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This draft guidance is provided for immediate use, and will be revised as needed based on comments received and changes in regulation and emergency response guidance. The draft guidance is available at: http://www.regulations.gov.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: [phone] or [e-mail].

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 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.