The PDF version 
Display Related Directives to this directive.
Display Reference Documents to this directive.
U.S. Department of Energy GUIDE
Washington, D.C. DOE G 151.1-5
7-11-07
BIOSAFETY FACILITIES
Emergency Management Guide
[This Guide describes suggested nonmandatory approaches for
meeting requirements. Guides are not requirements documents and
are not to be construed as requirements in any audit or appraisal
for compliance with the parent Policy, Order, Notice, or Manual.]
1. BIOSAFETY FACILITIES
1.1 Introduction
DOE O 151.1C, Comprehensive Emergency Management System,
describes the Department of Energy (DOE) and National
Nuclear Security Administration (NNSA) Emergency Management
System. The Order sets Departmental policy, assigns roles
and responsibilities, and provides the framework for the
development, coordination, control, and direction for
DOE/NNSA emergency management programs. Requirements for
emergency planning, preparedness, readiness assurance, and
response activities are established and the approach for
effectively integrating these activities under a
comprehensive, all-emergency concept is described. Using
this approach, a DOE/NNSA facility/site develops and
participates in an integrated and comprehensive emergency
management program to ensure that DOE can respond
effectively and efficiently to Operational Emergencies (OEs)
to protect workers, the public, and the environment.
Emergency management programs are designed to ensure that
all emergencies are promptly recognized and categorized,
emergencies are reported and notifications are made, and
parameters associated with the emergency are monitored to
detect changed or degraded conditions.
Since 1991, DOE/NNSA emergency management programs have
focused on radioactive materials and hazardous chemicals.
However, priorities in national security emphasizing anti-
terrorism have caused a change in national security research
priorities at DOE/NNSA facilities/sites to include studies
involving hazardous biological agents and/or toxins. The
use and storage of these materials in DOE/NNSA facilities
has the potential to harm workers and the general public, as
do toxic chemicals and radioactive materials, through an
unplanned event or condition that releases an agent or toxin
to the environment.
Integration of hazardous biological materials into the
emergency management program is directed by 10 Code of
Federal Regulations (CFR) 851, Worker Safety and Health
Program, Appendix A, 7. Biological safety. According to
this rule, contractors must establish and implement a
biological safety program that establishes an Institutional
Biosafety Committee (IBC) or equivalent. The IBC must review
the site’s security, safeguards, and emergency management
plans and procedures to ensure they adequately consider work
involving biological etiologic (i.e., disease causing)
agents. In addition, the biological safety program confirms
that the site safeguards and security plans and emergency
management programs address biological etiologic agents,
with particular emphasis on biological Select Agents. Other
Federal regulations that govern the use and storage of
Select Agents and Toxins (to be introduced in subsequent
chapters) require that mandated incident response planning
be “integrated with any site-wide emergency response plans.”
The purpose of this guidance is to assist DOE/NNSA field
elements and operating contractors in incorporating
hazardous biological agents/toxins into emergency management
programs. The intended result is an integrated and
comprehensive emergency management program that provides
assurances of a timely and effective response to an onsite
release of a radioactive, toxic chemical, or hazardous
biological material. Note that the guidance presented in
this document does not explicitly address acts of terrorism
in which biological agents or toxins, not owned or
controlled by DOE/NNSA, are brought onto a DOE/NNSA site or
facility.
It is not the intent of this guide to establish operational
biosafety requirements for biosafety facilities. Topics
[e.g., biological agents, Biosafety in Microbiological and
Biomedical Laboratories (BMBL) biosafety, BMBL risk
assessment, barriers) will be introduced to familiarize
emergency management personnel with various concepts related
to hazardous biological materials that they must be
cognizant of in order to address integration of hazardous
biological materials with site-wide emergency management
planning. Likewise, the discussions can also raise the
awareness of biosafety experts to recognize aspects of their
discipline that are important to emergency management
personnel. There has been no attempt to ensure completeness
in addressing the various topics in this section and in
Chapters 2 and 3. These chapters should not be used to
develop, implement, or evaluate a biosafety program. They
are focused simply on introducing biosafety concepts
relevant to emergency management programs.
1.2 General Approach
Each DOE facility/site or activity is required by
DOE O 151.1C to have an Operational Emergency Base Program,
which provides the framework for response to serious events
or conditions that involve the health and safety of workers
and the public, the environment, and safeguards and
security. Although DOE O 151.1C establishes several DOE-
unique requirements and a minimum set of generic
requirements for the Base Program, the framework for
response results mainly from the implementation of the
requirements of DOE regulations, other DOE orders, and
applicable non-DOE Federal, Tribal, State, and local
laws/regulations/ordinances. The specific requirements that
constitute the Operational Emergency Base Program are the
emergency planning and preparedness aspects of these Orders
and laws/regulations/ordinances. Examples of emergency
response features addressed in other DOE Orders and
laws/regulations/ ordinances include: medical support,
worker evacuation plans, fire drills, worker notification
systems, hazardous material communication, contingency
planning for oil spills, environmental spill drills and
exercises, and DOE security and safeguards requirements.
The objective of the Base Program is to achieve an effective
integration of emergency planning and preparedness
requirements into an emergency management program that
provides capabilities for all-emergency response, through
communication, coordination, and an efficient and effective
use of resources.
Some facilities may also require the implementation of an
Operational Emergency Hazardous Material Program. In
accordance with DOE O 151.1C, a facility that produces,
uses, or stores hazardous materials (i.e., radioactive,
chemical, or biological agents and toxins) in sufficient
quantities (radioactive or chemical materials) or
representing specific biological agents/toxins, which pose a
serious threat to workers, the public, or the environment,
must develop and maintain a quantitative Emergency Planning
Hazards Assessment (EPHA) and meet the more detailed
emergency planning requirements of a Hazardous Material
Program. Requirements of DOE O 151.1C apply to DOE/NNSA
facilities, as well as facilities not owned or managed by
the DOE, but built on DOE/NNSA land [see DOE O 151.1C,
4.a.(15), and DOE G 151.1-1A, Chapter 4].
For purposes of DOE O 151.1C and this Guide, a biosafety
facility can include a stand-alone building with a single
research activity, a floor in a building, or simply a
laboratory consisting of a single room or several rooms on a
floor in a building where storage is maintained or
work/research is performed involving biological etiologic
agents or hazardous biological toxins. A biosafety facility
will have an assigned containment level consistent with
applicable guidelines provided in Biosafety in
Microbiological and Biomedical Laboratories (BMBL), U.S.
Department of Health and Human Services (HHS), Public Health
Service (PHS), Centers for Disease Control and Prevention
(CDC) and National Institutes of Health (NIH), Fifth
Edition, 2007. The primary focus in this guidance is on
biosafety facilities that store or support activities
involving biological select agents or toxins, although the
approach can also be applied to other etiologic agents and
hazardous toxins.
Other activities in a building containing a biosafety
facility may be utilizing or storing radioactive or toxic
chemical hazardous materials. The Hazardous Material
Program for the building/facility should represent an
integration of planning, preparedness, and response
activities for all hazardous materials. For example, a
single EPHA should be produced for the facility covering
analyses of all hazardous materials identified in the
Hazards Survey. Similarly, response tools [e.g., Emergency
Action Levels (EALs); pre-planned protective actions] should
cover releases of all types of hazardous materials. Thus,
although the guidance in this document in the Emergency
Management Guide (EMG) (DOE G 151.1-series) focuses on
biological hazards, the facility/site planners will
ultimately integrate the biological aspects of the emergency
management program elements with those of other identified
hazardous materials to produce a single facility Hazardous
Material Program.
Specific guidance for implementing a Hazardous Material
Program at a DOE/NNSA facility/site can be found in the EMG,
DOE G 151.1-series, for facilities containing radioactive
materials and/or toxic chemicals. The purpose of
DOE G 151.1-5 is to address major aspects of an emergency
management program that need to be modified to include
emergency response to a release of hazardous biological
materials.
The primary requirements specific to DOE/NNSA biosafety
facilities using or storing select agents or toxins are
contained in the regulations from HHS and USDA regarding
certain hazardous biological agents and toxins and their
possession and use in the United States (U.S.), receipt from
outside the U.S., and transfer within the U.S. of certain
hazardous biological agents and toxins. For purposes of
this guidance, the CFR rules, which address the HHS and USDA
requirements, will be referred to collectively as the Select
Agent Rules. At a minimum, an entity registering under
these requirements needs to develop and implement an
incident response plan. For DOE/NNSA sites, the biosafety
facility incident response plan needs to be coordinated and
integrated with the implemented site-wide emergency plan.
The required contents of an incident response plan are
described in brief statements related to various emergency
management issues (e.g., identity/quantity of material
released, notifications, lines of authority and
communication, planning and coordination with local
emergency responders, and procedures to be followed by
employees performing rescue or medical duties). Emergency
management personnel at sites with planned or currently
operating biosafety labs will recognize that a DOE/NNSA
emergency management program addresses many of the same
issues in the Program Elements defined in DOE O 151.1C and
the other guidance documents in the DOE G 151.1-series (the
EMG). Although the major focus of the current DOE emergency
management Order and EMG is on radioactive and chemical
hazardous materials, requirements and guidance are generally
valid for biosafety facilities through modifications to
account for the unique properties and issues related to
biological hazards. As will become evident in subsequent
chapters of DOE G 151.1-5, emergency management plans and
programs already implemented on DOE/NNSA sites provide the
programmatic and response framework/structure and, in many
instances, the specific functions and activities
(e.g., training program, offsite interfaces) that will
support implementation of all response requirements included
in the Select Agent Rules.
Although many aspects of emergency management planning for
biological agents can be patterned after the traditional
hazardous materials approach that considers radioactive
materials and toxic chemicals, problems may arise in the
applicability and use of some traditional concepts and
methodologies/tools. The applicability of computer modeling
to biological release scenarios should be established for
the source and conditions of release represented in the
specific scenarios. Conventional modeling techniques, such
as Gaussian plume models, may not be appropriate for
planning calculations and consequence assessments during
response for the types, quantities, and release mechanisms
of biological agents/toxin of interest. For this reason,
and for others to be discussed later, the Order does not
require that biological releases be OEs requiring
classification (i.e., Alert, Site Area Emergency, or General
Emergency), as are traditional hazardous material releases.
Also, some non-traditional events involving biological
agents can result in releases (e.g., unobserved infected
host or contamination) that may not be recognized or
detected by the facility staff when they occur. In such
cases, detection of the release may only happen when people
present with infections at medical treatment locations,
onsite or offsite, in sufficient numbers to trigger
recognition of an OE.
OE response measures (e.g., protective actions) focus on
collocated workers, the public, and the environment outside
of the biosafety facility, while the biological worker
safety program response appropriate for the specific the
facility will focus primarily on protection of the
laboratory workers and the environment inside the biosafety
facility. The traditional approach to protective action
planning applied to biological releases has the additional
complication of infection control, which deals with vector
or person-to-person transmittal of the agent, after initial
infection of a receptor. Specific agent data can assist in
determining potential spread, dissemination, infectivity,
and treatment or prophylactic protocols that can influence
the selection of appropriate protective actions. As
indicated above, complications influencing application of
the traditional DOE hazardous materials approach to
biological releases dictates that each agent be analyzed and
researched to examine variations in agent characteristics
that may not be bounded by a standard hazardous materials
planning and response approach. Hence, emergency management
planners need to familiarize themselves with the specifics
of each agent in use in the biosafety facility to augment
the standard planning and response template, as necessary.
In contrast to the complications mentioned above, there are
underlying concepts in the DOE emergency management approach
that strongly influence the basic methodology for planning
and response to any hazardous materials release. Hence, any
discussion of an approach to DOE emergency management for
biosafety facilities should be prefaced with a discussion of
the three key concepts that strongly influence the
methodology presented in the DOE G 151.1-series. These
essential, governing concepts are the following (Cf.
DOE G 151.1-1A, Chapter 1):
· Effective response is the “last line of defense” against
adverse consequences. Regardless of how sound fundamental safety
programs and hazard controls may be, events will occur that have
adverse health effects on people and/or the environment. This
principle expresses the DOE position that if hazard controls
should fail, the facility/site should be prepared to take actions
to limit or prevent adverse health and safety impacts to workers
and the public.
· Planning, preparedness, response, and recovery must be
specific to and “commensurate with the hazards.” DOE/NNSA is
responsible for a large number of different hazards that could
threaten the health and safety of workers or the public if
released to the environment. Hazards are very different in the
nature of their impacts on people, their behavior in the
environment and the distance at which adverse impacts would be
experienced. While the basic emergency management framework is
the same for all DOE/NNSA sites and facilities, specific planning
and response measures for each hazard are to be tailored to the
hazard. This is especially important when implementing Hazardous
Materials Program requirements for biosafety facilities that may
contain small quantities of agents or toxins; the requirements
may result in a function or activity that is comparable to a Base
Program scale component. For requirements that are not in a Base
Program, the tailoring may result in a near minimal version of
the Hazardous Materials Program function/activity. In any case,
it is extremely important to document the tailoring to hazards
that resulted in the implemented function or activity.
· “Early recognition” is vital to timely, effective response.
In many cases, warning potentially affected workers and the
public and directing them to take actions to prevent or limit
their exposure is the only way that mitigating the adverse health
impacts of hazardous material releases can be accomplished.
Hence, early recognition of a release event is essential if
warnings are to be delivered in time to be executed effectively.
Note that these concepts are repeated and emphasized here
because they have an overarching influence on both the
development and implementation of emergency management
programs for hazardous biological materials presented in
DOE G 151.1-5.
The guidance contained here is aimed at both biosafety and
emergency management professionals responsible for
implementing the Select Agent Rules and DOE O 151.1C. To
satisfy the needs of both disciplines, the general subject
of biosafety is introduced in Chapter 2. Biosafety concepts
of containment and barriers, Biosafety Levels (BSLs), and
biosafety controls are introduced in the context of the
Select Agent Rules and are taken directly from the Centers
for Disease Control (CDC)/National Institutes of Health
(NIH) publication, Biosafety in Microbiological and
Biomedical Laboratories (BMBL). Note that descriptions of
facility operations or biosafety programs are provided to
support examples and concepts discussed in Chapter 2.
However, these descriptions should not be interpreted as
necessarily representing actual DOE/NNSA biosafety facility
operations and programs.
According to 10 CFR 851 Appendix A, 7. Biological safety,
DOE/NNSA biosafety facilities are required to establish an
IBC to review any work with biological etiologic agents for
compliance with appropriate CDC (i.e., BMBL), NIH, World
Health Organization (WHO), and other international, Federal,
Tribal, State, and local guidelines and the site security,
safeguards, and emergency management plans and procedures.
Understanding the basic biosafety concepts contained in
these guidelines is essential for interpreting and
implementing the guidance to be presented in this guidance
document. In addition, because of the impact that agent
characteristics and diverse transport/transmission
mechanisms have on specific emergency management planning
issues (e.g., threshold quantities, measures of severity,
protective actions), Chapter 3 provides a brief discussion
of these issues to support the approach contained in
DOE O 151.1C and the DOE G 151.1-series. Agents and their
relevant general characteristics are discussed with special
emphasis on potential transport/transmission mechanisms.
OEs related to the release of biological agents to the
environment, the characterization of biological release
scenarios, and tools for their recognition are also
discussed.
Basic program elements of the DOE/NNSA emergency management
system are presented in Chapters 4 through 6. Chapter 4
addresses the technical planning basis for the emergency
management program, where the Hazards Survey is the first
component of the technical planning basis. The Hazards
Survey identifies requirements of the Base Program and the
need for further analysis of hazardous biological materials
in an EPHA. As for all hazardous materials, the EPHA will
provide the technical planning basis for the emergency
management Hazardous Material Program. This analysis and
the Hazardous Material Program, which are required for any
DOE/NNSA facility subject to the Select Agent Rule(s),
address the actual or potential release of biological agents
outside of the secondary barriers of biocontainment.
Results of the EPHA will form the basis for the emergency
management program that will be commensurate with the
biological hazards in the facility. Planning, preparedness,
and response activities will
reflect the characteristics and release
transport/transmission mechanisms of the potential hazards.
Because a strictly quantitative analysis of Select Agents
may not be an appropriate or feasible planning technique for
many biological sources found in DOE/NNSA facilities, a
structured qualitative analysis approach is presented for
EPHAs, which can be used to reveal release scenario
parameters necessary for recognizing OEs and for developing
initial protective action strategies for protecting onsite
workers and the offsite public. Appendix A contains several
notional OE release scenarios developed to provide examples
of the analysis approach.
Chapters 5 and 6, which contain guidance related to
programmatic and response elements, address selected issues
that should be modified by the presence of hazardous
biological materials in the facilities. Some requirements
of the Select Agent Rules and their integration into
existing program elements are also described. Other aspects
of the elements may be modified by the existence of Select
Agents, but are not explicitly addressed. DOE G 151.1-1A
through DOE G 151.1-4 should be used for more general issues
(e.g., emergency public information, offsite interfaces)
related to program elements. Users should always be aware
that the guidance may have to be adjusted because the
specific facility emergency management program is focused on
hazardous biological materials.
Biological Select Agents are emphasized in the guidance
contained in DOE G 151.1-5; biological toxins are
essentially extremely toxic chemicals generally covered by
guidance contained DOE G 151.1-1A through DOE G 151.1-4.
However, clarifications and discussions in this Guide will
specifically address the release of toxins when necessary
(e.g., classification not required for biological toxin
releases). In addition, this current version of
DOE G 151.1-5 will focus on planning for human or overlap
(i.e., able to infect both humans and animals) Select
Agents. Future guidance will include toxins and agents that
are solely animal and plant pathogens.
2. HAZARDOUS BIOLOGICAL MATERIALS AND BIOSAFETY
The purpose of this chapter is to provide a brief
introduction to characteristics of hazardous biological
materials and biosafety concepts related to the safe use and
storage of these materials in approved facilities. An
understanding of basic biosafety concepts will facilitate
the integration of biosafety requirements and DOE/NNSA
facility/site emergency management program elements.
Although much of this chapter was taken directly from the
BMBL, its contents should not be used to develop, implement,
or evaluate biosafety programs for DOE/NNSA biosafety
facilities. Original NIH, CDC, and WHO reference materials
should be accessed for a complete and in-depth presentation
of the guidance for interpretation or implementation of the
various biosafety concepts to be discussed in the following
sections.
2.1 Hazardous Biological Agents and Toxins
Biological materials that may be associated with DOE/NNSA
facilities fall into two major categories: biological
agents (i.e., microorganisms) and biological toxins.
Hazardous biological agents include naturally occurring or
genetically modified microorganisms (e.g., bacteria,
viruses) that can cause disease and death in an exposed and
vulnerable population. Biological toxins are toxic
chemicals that are biologically produced and behave in the
environment much like other toxic chemicals. However, these
toxins represent some of the most hazardous in the category
of toxic chemicals. An extremely small amount of either an
infectious biological agent or a biological toxin can cause
disease, severe toxic reaction, or death.
The following briefly describe types of hazardous biological
materials may be handled, cultivated, and/or stored in
DOE/NNSA laboratories:
· Bacteria are typically single-celled microorganisms that
lack chlorophyll and reproduce by simple division (fission).
Bacteria can grow in nature outside of a human or animal host and
in a liquid culture or on semi-solid media (e.g., agar) in a
laboratory environment. Pathogenic bacteria cause disease when
they establish themselves and reproduce in humans or animals.
Some bacteria (e.g., Bacillus anthracis) are able to form spores,
which is an extremely stable condition that allows them to
survive in hostile environments. Most infections resulting from
exposure to bacterial agents can be effectively treated with
antibiotics, provided treatment is initiated early enough in the
course of illness.
– Rickettsiae are true bacteria, but, like viruses, they
require living cells for growth outside of a laboratory
environment. Many rickettsiae are localized to certain
geographic areas and are maintained in nature by a cycle
involving an animal reservoir and an arthropod vector (insects,
arachnids, etc.) that infects humans.
· Viruses are ultramicroscopic, infectious agents consisting
of nucleic acid and protein that do not survive and reproduce in
nature outside of a living human or animal host. Viruses use the
cellular machinery of the living host to reproduce. However,
viruses can be maintained in artificial laboratory environments
for extended periods of time. The stability of various types of
viruses in natural environments, outside of a host, varies and,
for laboratory purposes, may be artificially extended.
Vaccination is a suitable protective measure for some viruses,
such as smallpox, as long as it is successfully administered
prior to exposure. In some cases, vaccinations can decrease the
severity of disease, even if administered after exposure.
Antibiotics are not effective against viruses and very few
antiviral treatments are available.
· Toxins are poisonous, non-living chemicals produced during
metabolism and growth of living organisms. The source of toxins
can be microorganisms, such as bacteria, and some higher plant
and animal species, including fungi, plants, spiders and fish.
Examples are botulinum toxin, from the anaerobic bacteria
Clostridium botulinum; ricin, from the castor bean plant; and
tetrodotoxin from the puffer fish. Most biological toxins are
relatively stable in the environment. Medical treatments are
generally limited to supportive care. The time for onset of
symptoms for biologically produced toxins is typically on the
order of minutes to hours. Fatalities may occur hours to days
from exposure.
2.2 Select Agent Regulations
Federal regulations establishing requirements for certain
biological agents and toxins regarding their possession and
use in the U.S., receipt from outside the U.S., and transfer
within the U.S. are:
· 42 CFR 73, Select Agents and Toxins. Contains two lists of
agents and toxins regulated by HHS/CDC: 1) HHS Select Agents and
Toxins; and 2) Overlap (posing severe threats to both humans and
animals) Select Agents and Toxins.
· 7 CFR 331, Possession, Use, and Transfer of Select Agents
and Toxins. Contains a list of Plant Protection and Quarantine
Programs (PPQ) of the Animal and Plant Health Inspection Service
(APHIS), Select Agents and Toxins.
· 9 CFR 121, Possession, Use, and Transfer of Select Agents
and Toxins. Contain two lists: 1) Veterinary Services Programs
(VS) of the APHIS, Select Agents and Toxins; and 2) Overlap
Select Agents and Toxins.
HHS Select Agents and Toxins pose severe threats to humans
alone, while overlap Select Agents and Toxins pose severe
threats to both humans and animals. Overlap Select Agents
and Toxins are subject to regulation by both CDC and APHIS;
the lists are identical in both regulations. PPQ Select
Agents and Toxins have the potential to pose a severe threat
to plant health or to plant products. VS Select Agents and
Toxins have the potential to pose a severe threat to animal
health or animal products. Note that the total aggregate
quantity of each toxin under the control of a “principal
investigator, treating physician or veterinarian, or
commercial manufacturer or distributor” in a biosafety
facility must exceed quantities specified in their
respective regulations to be subject to rule requirements,
while no quantity is specified for biological agents. In
addition, Select Agents or Toxins may also be excluded from
the regulations if they meet any of several other criteria
(e.g., non-viable Select Agents or nonfunctional Toxins).
As indicated in Chapter 1, the three rules will be referred
to as the Select Agent Rules for purposes of this guidance,
unless there is a reason to cite the specific rule.
The entities regulated under the Select Agent Rules include
Federal facilities/laboratories. The rules establish
requirements concerning registration, security risk
assessments, safety plans, security plans, incident response
plans, training, transfers, record keeping, inspections, and
notifications. The external exportation and transportation
of these materials are not covered under this rule; the U.S.
Department of Commerce (DOC) and DOT regulate these
activities.
A key element of the HHS/CDC regulations is the development
and implementation of a safety plan considering the
following biosafety standards and Federal regulations:
· CDC/NIH publication, Biosafety in Microbiological and
Biomedical Laboratories (BMBL);
· OSHA regulations in 29 CFR 1910.1200, Hazard communication,
and 29 CFR 1910.1450, Occupational exposure to hazardous
chemicals in laboratories; and
· NIH Guidelines for Research Involving Recombinant DNA
Molecules (April 2002).
The APHIS regulation related to PPQ Select Agents/Toxins
(plant pathogens) is not specifically addressed in this
version of DOE G 151.1-5.
2.3 Principles of Biosafety, Containment, and Barriers1
Biosafety is the discipline addressing the safe handling and
containment of infectious microorganisms and hazardous
biological materials. The two basic principles of biosafety
are containment and risk assessment, as defined below:
· The fundamentals of containment include the microbiological
practices, safety equipment, and facility safeguards that protect
laboratory workers, the environment, and the public from exposure
to infectious microorganisms that are handled and stored in the
laboratory.
· Risk assessment is the process that enables the appropriate
selection of microbiological practices, safety equipment, and
facility safeguards that can prevent laboratory-associated
infections (LAI).
Risk assessment is the BMBL biosafety methodology used to
select the appropriate microbiological practices, safety
equipment, and facility safeguards that define the level of
containment to be implemented in a facility/laboratory,
commensurate with the hazards associated with the biological
agent(s) used or maintained within. The risk assessment
process is similar in purpose to the EPHA process, which
results in the emergency management technical planning basis
for commensurate-with-hazards Hazardous Materials Programs
at DOE/NNSA facilities/sites.
The principles of biosafety and the associated risk
assessment process are described in the BMBL. All
facilities registered under 42 CFR 73 or 9 CFR 121 are
required by the regulation to consider the BMBL in
developing their safety programs. The BMBL describes a
comprehensive approach that evaluates hazards of the
biological agents present in the facility, the type of work
to be performed, and the mitigative features utilized
(e.g., vaccines, training, medical surveillance). The
application of this risk assessment process results in a
determination of the appropriate biosafety level (BSL) for
each infectious biological agent/toxin to be used or stored
in the facility. The information developed for the risk
assessment process (e.g., Agent Summary Statements) will
provide much of the information needed as input to the EPHA
process for the biosafety facility.
Facilities/laboratories, equipment, and procedures
appropriate for work with toxins of biological origin should
also reflect the intrinsic level of hazard posed by a
particular toxin as well as potential risks inherent in the
operations performed. If both toxins and infectious agents
are used, then both need to be considered when containment
equipment is selected and when policies and procedures are
written. If animals are used, animal safety practices must
also be considered.
A basic understanding of containment and barriers is
essential for developing an integrated emergency management
program that addresses all hazards. The term containment
(or equivalently, biocontainment) is used in describing safe
methods for managing infectious materials in the laboratory
environment where they are being handled or maintained. The
purpose of containment is to reduce or eliminate exposure of
laboratory workers, other persons, and the outside
environment to potentially hazardous agents. The use of
vaccines may provide an increased level of personal
protection.
The BMBL defines three elements of containment:
· Laboratory Practice and Technique. The most important
element of containment is strict adherence to standard
microbiological practices and techniques. Persons working with
infectious agents or potentially infectious materials should be
aware of potential hazards and must be trained and proficient in
the practices and techniques required for handling such material
safely. The BMBL recommends that each laboratory develop or
adopt a biosafety or operations manual that identifies the
hazards that will or may be encountered and that specifies
practices and procedures designed to minimize or eliminate
exposures to these hazards. Personnel are advised of special
hazards and are required to read and follow the required
practices and procedures.
When standard laboratory practices are not sufficient to
control the hazards associated with a particular agent or
laboratory procedure, additional measures may be needed.
The laboratory director is responsible for selecting
additional safety practices, which must be commensurate
with the hazards associated with the agent or procedure.
Strict adherence to standard microbiological practices
and techniques (including additional measures) by
laboratory personnel is supplemented by appropriate
facility design and engineering features, safety
equipment, and management practices.
· Safety Equipment (Primary Barriers and Personal Protective
Equipment). Safety equipment includes Biological Safety Cabinets
(BSCs), enclosed containers, and other engineering controls
designed to eliminate or minimize potential exposures to
hazardous biological materials. The BSC is the principal device
used to provide containment of infectious splashes or aerosols
generated by many microbiological procedures. Three types of
BSCs (Class I, II, III) are used in microbiological laboratories:
open-fronted Class I and Class II BSCs, which are primary
barriers that offer significant levels of protection to
laboratory personnel and to the environment when used with good
microbiological techniques, and gas-tight the Class III BSC,
which provides the highest attainable level of protection to
personnel and the environment. [Schematics of these BSCs can be
found in Appendix A of BMBL (2007)]. An example of another
primary barrier is the safety centrifuge cup, an enclosed
container designed to prevent aerosols from being released during
centrifugation. To minimize aerosol hazards, containment
controls, such as BSCs or centrifuge cups, are recommended when
handling infectious agents.
Safety equipment may also include items for personal
protection, such as gloves, coats, gowns, shoe covers,
boots, respirators, face shields, safety glasses, or
goggles. Such Personal Protective Equipment (PPE) is
often used in combination with BSCs and other devices
that contain the agents, animals, or materials being
handled. In some situations in which it is impractical
to work in BSCs, PPE may form the primary barrier between
personnel and the infectious materials.
· Facility Design and Construction (Secondary Barriers). The
design and construction of the biosafety facility (also referred
to in the BMBL as facility safeguards) contributes to laboratory
worker protection, provides a barrier to protect persons outside
the laboratory and protects persons or animals in the community
from infectious agents that may be accidentally released from the
laboratory.
The recommended secondary barrier(s) will depend on the
risk of transmission of specific agents. For example,
when the exposure risks for most laboratory work in a
biosafety facility will be direct contact with the
agents, or inadvertent contact exposures through
contaminated work environments, then secondary barriers
in these laboratories may include separation of the
laboratory work area from public access, availability of
a decontamination facility (e.g., autoclave), and hand
washing facilities.
When the risk of infection by exposure to an infectious
aerosol is present, higher levels of primary containment
and multiple secondary barriers may become necessary to
prevent infectious agents from escaping into the
environment. Such design features include specialized
ventilation systems to ensure directional air flow, air
treatment systems to decontaminate or remove agents from
exhaust air, controlled access zones, airlocks as
laboratory entrances, or separate buildings or modules to
isolate the laboratory.
Containment includes microbiological practices, safety
equipment, and facility safeguards that protect laboratory
workers, the environment, and the public. Two tiers/ layers
of protection provided by containment are defined as
follows:2
· Primary containment – focused on the protection of biosafety
facility/laboratory workers and the immediate laboratory
environment from exposure to infectious agents and provided by
both good microbiological techniques and the use of appropriate
safety equipment.
· Secondary containment – focused on the protection of the
environment external to the laboratory from exposure to
infectious materials and provided by a combination of facility
design and construction practices.
Process of biological risk assessment will determine the
appropriate levels of primary and secondary containment for
each infectious biological agent to be used or stored in the
facility. As will be discussed in subsequent chapters,
these tiers/layers of containment play a key role in
defining HHS/CDC notification criteria and DOE/NNSA
Operational Emergencies.
2.4 Risk Assessment and Biosafety Levels3
Risk assessment is a process used to identify the hazardous
characteristics of a known infectious or potentially
infectious agent or material, the activities that can result
in a person’s exposure to an agent, the likelihood that such
exposure will cause a LAI, and the probable consequences of
such an infection. The information identified by a risk
assessment will provide a guide for the selection of
appropriate BSLs and associated microbiological practices,
safety equipment, and facility safeguards that can prevent
LAIs; the information will also provide much of the basic
data required for performing an emergency management hazards
assessment. Biological risk assessment is an important
responsibility of directors and principal investigators in
DOE/NNSA biosafety facilities. IBCs and other biological
safety professionals should also share in this
responsibility.
The primary factors to consider in risk assessment and the
selection of biosafety precautions fall into two broad
categories: agent hazards and laboratory procedure hazards.
In addition, the capability of the laboratory staff to
control the hazards must also be considered. This capability
will depend on the training, technical proficiency, and good
habits of all members of the laboratory, and the operational
integrity of containment equipment and facility safeguards.
· Agent hazards. The principal hazardous characteristics of
an agent are its capability to infect and cause disease in a
susceptible human or animal host, its virulence as measured by
the severity of disease, and the availability of preventive
measures and effective treatments for the disease. Other
hazardous characteristics of an agent include probable routes of
transmission of laboratory infection, infective dose, stability
in the environment, host range, and its endemic nature. The
origin of the agent is also important in risk assessment. Non-
indigenous agents are of special concern because of their
potential to introduce risk of transmission, or spread of human
and animal or infectious diseases, from foreign countries into
the United States.
For genetically-modified agent hazards, it is
particularly important to address the possibility that
the genetic modification could increase an agent’s
pathogenicity or affect its susceptibility to antibiotics
or other effective treatments. Workers who handle or
manipulate human or animal cells and tissues are at risk
for possible exposure to potentially infectious latent
and adventitious agents that may be present in those
cells and tissues. In addition, human and animal cell
lines that are not well characterized or are obtained
from secondary sources may introduce an infectious hazard
to the laboratory.
· Laboratory procedure hazards. Investigations of LAIs have
identified five principal routes of laboratory transmission.
These are parenteral inoculations with syringe needles or other
contaminated sharps, spills and splashes onto skin and mucous
membranes, ingestion through mouth pipetting, animal bites and
scratches, and inhalation exposures to infectious aerosols.
Aerosols are a serious hazard because they are ubiquitous
in laboratory procedures, are usually undetected, and are
extremely pervasive, placing the laboratory worker
carrying out the procedure and other persons in the
laboratory at risk of infection. There is general
agreement among biosafety professionals, laboratory
directors and principal investigators who have
investigated LAIs that an aerosol generated by procedures
and operations is the probable source of many LAIs,
particularly in cases involving workers whose only known
risk factor was that they worked with an agent or in an
area where that work was done.
· Capability of the laboratory staff to control the hazard.
Laboratory workers must be well aware of hazardous
characteristics of laboratory procedures which may be associated
with the agents. Workers are the first line of defense for
protecting themselves, others in the laboratory, and the public
from exposure to hazardous agents. Protection depends on the
conscientious and proficient use of good microbiological
practices and the correct use of safety equipment. Training,
experience, knowledge of the agent and the procedure hazards,
good habits, caution, attentiveness, and concern for the health
of coworkers are prerequisites for a laboratory staff in order to
reduce the inherent risks that attend work with hazardous agents.
Not all workers who join a laboratory staff will have these
prerequisite traits, even though they may possess excellent
scientific credentials. Laboratory directors or principal
investigators should train and retrain new staff to the point
where aseptic techniques and safety precautions become second
nature.
The capability of the laboratory staff to control the
hazards also depends on the operational integrity of
containment equipment and facility safeguards. An active
surveillance program, which monitors the status of
containment equipment and facility safeguards and ensures
that periodic inspections, operational checks, calibration,
preventive maintenance and tests are carried out as
required, can provide assurances that equipment and
safeguards will perform as expected. Routine surveillance
programs are discussed in more detail in Section 2.5.
Biological risk assessment is a subjective process requiring
consideration of many hazardous characteristics of agents
and procedures, with judgments based often on incomplete
information. Although there is no standard approach for
conducting a biological risk assessment, the five-step
approach presented in BMBL (2007) gives some structure to
the risk assessment process.
Using the results of the risk assessment, the primary risk
criteria used to define the four ascending levels of
containment, referred to as biosafety levels 1 (BSL-1)
through 4 (BSL-4), are: infectivity, severity of disease,
transmissibility, and the nature of the work being
conducted. Another important risk factor for agents that
cause moderate to severe disease is the origin of the agent,
whether indigenous or exotic.
BSL-1 is the basic level of protection and is appropriate
for agents that are not known to cause disease in normal,
healthy humans. BSL-2 is appropriate for handling moderate-
risk agents that cause human disease of varying severity by
ingestion or through percutaneous or mucous membrane
exposure. BSL-3 is appropriate for agents with a known
potential for aerosol transmission, for agents that may
cause serious and potentially lethal infections and that are
indigenous or exotic in origin. Exotic agents that pose a
high individual risk of life threatening disease by
infectious aerosols and for which no treatment is available
are restricted to high containment laboratories that meet
BSL-4 standards.
Each level of biosafety containment describes the
microbiological practices, safety equipment, and facility
safeguards for the corresponding level of risk associated
with handling a particular agent. Similarly associated with
each biosafety level is a level of primary and secondary
containment commensurate with the agent risk.
The essential elements of the four biosafety levels for
activities involving infectious microorganisms and
laboratory animals are summarized in Table 2-1. The levels
are designated in ascending order, by degree of protection
provided to personnel, the environment, and the community.
Standard microbiological practices are common to all
laboratories. Special microbiological practices enhance
worker safety, environmental protection, and address the
risk of handling agents requiring increasing levels of
containment.
Table 2-1. Summary of Essential Elements of the Four BMBL
Biosafety Levels (BSLs) for Infectious Agents4
BS Agents Practices Primary Facilities
L Barriers and (Secondary
Safety barriers)
Equipment
1 Not known to Standard None required Open bench
consistently Microbiologica and sink
cause l Practices required
diseases in
healthy
adults
2 · Agents · BSL-1 Primary BSL-1 plus:
associated practice plus: barriers:
with human · Limited ·
disease access · Class I Autoclave
· Biohazard or II BSCs or available
· Routes warning signs other physical
of · “Sharps” containment
transmission precautions devices used
include · Biosafety for all
percutaneous manual manipulations
injury, defining any of agents that
ingestion, needed waste cause splashes
mucous decontaminatio or aerosols of
membrane n or medical infectious
exposure surveillance materials
policies
PPEs*:
·
Laboratory
coats, gloves,
face
protection as
needed
3 · BSL-2 practice Primary BSL-2 plus:
Indigenous orplus: barriers:
exotic agents ·
with · · Class I Physical
potential for Controlled or II BSCs or separation
aerosol access other physical from access
transmission containment corridors
· devices used
· Disease Decontaminatio for all open · Self-
may have n of all waste manipulations closing,
serious or · of agents double-door
lethal Decontaminatio access
consequences n of lab PPEs*: · Exhaust
clothing air not
before · recirculated
laundering Protective lab ·
· Baseline clothing, Negative
serum gloves, airflow into
respiratory laboratory
protection as
needed
4 · BSL-3 Primary BSL-3 plus:
Dangerous/exopractices barriers:
tic agents plus: ·
which pose · All Separate
high risk of · Clothing procedures building or
life- change before conducted in isolated
threatening entering Class III BSCs zone
disease or Class I or
· Shower on II BSCs in ·
· Aerosol- exit combination Dedicated
transmitted · All with full- supply and
lab material body, air- exhaust,
infections; decontaminated supplied, vacuum, and
or related on exit from positive decontaminat
agents with facility pressure ion systems
unknown risk personnel suit · Other
of requirements
transmission outlined in
BMBL
* PPE – Personal Protective Equipment
Note that the risk assessment process for assigning agents
to BSL facilities may not be entirely appropriate for
prioritizing or judging risk for emergency management
purposes. Emergency management should characterize
hazardous materials in terms of their inherent risk given a
release to the environment, and should not be based on a
risk assessment that is modified by factors that are
primarily focused on worker safety. Thus, BMBL methodology
results, although generally appropriate for emergency
management purposes, may be inappropriate for characterizing
risks once an agent has entered the environment.
2.5 Routine Surveillance of Biosafety Controls
The routine surveillance of biosafety protocols and
practices, safety equipment, and facility systems can
provide assurances that required maintenance, equipment
tests, certifications, inspections, reviews, and other
activities intended to maintain laboratory control measures
at a high level of performance are accomplished as required.
In addition, a rigorous and structured approach to these
surveillance activities provides the opportunity for
recognizing abnormal events or conditions that, in
combination with other events or conditions, might indicate
the potential for the unobserved release of a hazardous
biological material from the biocontainment area. For
example, discovery of an abnormal condition associated with
a primary barrier during a routine inspection or test could
initiate further investigation of other barriers that, if
failed during the same time frame, might indicate the
potential for a release to the environment.
The essential elements of the four biosafety levels for
activities involving infectious microorganisms are
summarized in Table 1 of the previous section. In addition
to these elements, Chapter IV of the BMBL (2007) also lists
various routine monitoring, testing, certification, and
verification activities associated with each biosafety
level. Examples of routine surveillance appropriate for
monitoring biological facilities can include operational,
equipment & facility, and medical surveillance. Training
and skill level for at-risk personnel can also be monitored
to provide assurances that a high level of performance is
maintained.
Selected examples of routine surveillance activities taken
from the BMBL (2007) are presented below:5
· Operational Surveillance is conducted to ensure that
procedures and protocols are in place and effective. Examples
include:
– Along with limited applications of pesticides, pest control
is achieved through implementation of an Integrated Pest
Management (IPM) program consisting of proactive operational and
administrative intervention strategies to correct conditions that
foster pest problems. Monitoring is the central activity of an
IPM program and is used to minimize pesticide use. Traps, visual
inspections, and staff interviews identify areas and conditions
that may foster pest activity. Records of structural
deficiencies and housekeeping conditions should be maintained to
track problems and determine if corrective actions have been
completed in a timely manner and were effective. Quality
assurance and program review should be performed to provide an
objective, ongoing evaluation of IPM activities and effectiveness
to ensure that the program does, in fact, control pests and meet
the specific needs of the facility program(s) and its occupants.
– Laboratory personnel must receive specific training in
handling pathogenic and potentially lethal agents and must be
supervised by scientists competent in handling infectious agents
and associated procedures.
· Equipment & Facility Surveillance can help ensure that
safety-related equipment and facility systems are operating
within appropriate parameters. Examples include:
- Laboratory personnel must be able to verify directional air
flow. A visual monitoring device, which confirms directional air
flow, must be provided at the laboratory entry. Audible alarms
should be considered to notify personnel of air flow disruption.
- High-Efficiency Particulate Air (HEPA)-filtered exhaust air
from a Class II BSC can be safely re-circulated into the
laboratory environment if the cabinet is tested and certified at
least annually and operated according to manufacturer’s
recommendations.
- Provisions to assure proper safety cabinet performance and
air system operation must be verified. BSCs should be certified
at least annually to assure correct performance.
- Equipment that may produce infectious aerosols must be
contained in devices that exhaust air through HEPA filtration or
other equivalent technology before being discharged into the
laboratory. These HEPA filters should be tested and/or replaced
at least annually.
- HEPA filter housings should have gas-tight isolation
dampers; decontamination ports; and/or bag-in/bag-out (with
appropriate decontamination procedures) capability. The HEPA
filter housing should be certified at least annually.
- The BSL-3 facility design, operational parameters, and
procedures must be verified and documented prior to operation.
Facilities must be re-verified and documented at least annually.
· Medical Surveillance helps verify that personnel safeguards
implemented for a biosafety program produce the expected health
outcomes. It may include serum banking, monitoring of employee
health status, and participating in post-exposure management.
This monitoring activity is similar to routine bioassays taken as
part of selected radiation protection programs. Similarly,
medical surveillances are required by various health and safety
regulations for workers involved with hazardous chemicals. A
documented medical surveillance program should be implemented
that defines at-risk positions, specifies risks versus benefits
of prophylactic immunization, and distinguishes between required
and recommended vaccines for specific organisms. A practiced
plan for rapid response to a post-exposure event should include
the ability to rapidly track personnel location, potential
exposure, movement, and method for testing and prophylaxis.
Selected examples of medical surveillance activities from
the BMBL (2007) are presented below:
- Laboratory personnel must be provided medical surveillance
and offered appropriate immunizations for agents handled or
potentially present in the laboratory.
- Each institution must establish policies and procedures
describing the collection and storage of serum samples from at-
risk personnel.
- Incidents that may result in exposure to infectious
materials must be immediately evaluated and treated according to
procedures described in the laboratory biosafety safety manual.
All such incidents must be reported to the laboratory supervisor.
Medical evaluation, surveillance, and treatment should be
provided and appropriate records maintained.
A medical surveillance program with expanded post-
exposure symptom recognition and reporting linked to
community response assets differs from a standard
hazardous materials approach. Employee education with
agent-specific updates, rapid tracking, screening,
definitive laboratory testing, prophylaxis and treatment
pharmaceuticals, as well as appropriate access to
diagnostic and supportive medical care are key elements
to an effective, community integrated medical
surveillance program.
· Training and Skill Level Surveillance of at-risk positions
such as laboratory technicians/workers and maintenance,
housekeeping, and animal care personnel can help to ensure
employee safety. This surveillance activity involves the
establishment of a regular, documented education/recertification
process, which tracks personnel functions and activities to
ensure that training for their duties is appropriate and current.
Selected examples of experience and skill level
surveillance activities taken from the BMBL (2007) are
presented below:
- The laboratory supervisor must ensure that laboratory
personnel receive appropriate training regarding their duties,
the necessary precautions to prevent exposures, and exposure
evaluation procedures. Personnel must receive annual updates or
additional training when procedural or policy changes occur.
- The laboratory supervisor must ensure that laboratory
personnel demonstrate proficiency in standard and special
microbiological practices before working with BSL-3 agents.
These examples of general surveillance activities can be
potential sources of recognition factors to be utilized in
developing an Emergency Action Level (EAL)-like tool that
will
be part of the DOE emergency management program for
biosafety facilities. For this purpose, routine
surveillance should include an active process that
integrates and interprets the data in the context of
potential release scenarios, rather than simply as
individual datum to be monitored, compared to expected
performance or requirements, and recorded.
3. OPERATIONAL EMERGENCIES INVOLVING THE RELEASE OF HAZARDOUS
BIOLOGICAL MATERIALS
The purpose of this chapter is to introduce emergencies
involving the release of hazardous biological materials from
a DOE/NNSA biosafety facility. The following issues will be
discussed:
· Hazardous biological materials covered under DOE O 151.1C
· Issues related to hazardous biological materials and
emergency management
· Definition of the DOE Operational Emergency (OE) involving
the release of biological materials from a biosafety facility
into the environment
· Transport mechanisms potentially involved in biological OEs
· Characterization of OE release scenarios involving
biological agents
This chapter will focus primarily on biological agents, not
toxins. Emergency planning for the release of biological
toxins to the environment is similar to that for the release
of a toxic chemical. Its extreme toxicity, however, places
it in a special category for regulation and, as defined in
DOE O 151.1C, in the same OE category (i.e., events that do
not require classification) as hazardous biological agents.
3.1 DOE O 151.1C and Hazardous Biological Materials
The emergency management order, DOE O 151.1C, includes
criteria for identifying hazardous biological materials
subject to its requirements. In addition, according to the
Order, each DOE/NNSA facility with specific biological
agents or toxins that pose a serious threat to workers, the
public, or the environment, must develop and maintain a
“quantitative Emergency Planning Hazards Assessment (EPHA)
and meet more detailed emergency planning requirements.” At
a minimum, these agents and toxins must include “ . . .
Federally regulated agents and toxins identified in lists
published by the Department of Health and Human Services
(HHS) in 42 CFR 73 and the Department of Agriculture (USDA)
in 7 CFR 331 and 9 CFR 121.” If any listed biological
agents or toxins are excluded from federal regulation under
the Select Agent Rules [e.g., 42 CFR 73.3(d)], then the
exclusion also applies to the requirements of DOE O 151.1C.
According to DOE O 151.1C, if a DOE/NNSA facility is
governed by HHS and/or USDA Select Agent Rules because it
uses and/or stores Select Agents or Toxins, then an EPHA
needs to be prepared and an Operational Emergency Hazardous
Material Program is required for that facility. The scope
and contents of an EPHA for hazardous biological materials
are described in Chapter 4 of this Guide. Subsequent
chapters address the DOE Emergency Management Program
Elements that constitute the Hazardous Material Program.
Although the requirements of the current version of
DOE O 151.1C and this guidance document focus on Select
Agents and Toxins, other hazardous biological materials used
or stored at biosafety facilities may also have the
potential to harm workers and the general public. An
emergency management program consistent with the current
Order and Guide can be developed and implemented that
provides workers and the public with an appropriate level of
protection from non-Select Agents/Toxins.
3.2 Emergency Management Issues
Hazardous biological agents are similar to hazardous
chemicals and radioactive materials in that they:
· Are defined as hazardous materials in the Hazardous Waste
Operations and Emergency Response (HAZWOPER) standard
(29 CFR 1910.120)
· They (most) can be dispersed into the air to pose a threat
to workers and the public via the inhalation pathway
· Have a range of responses to environmental conditions
The characteristics of hazardous biological agents differ
from other hazardous materials and these differences impact
DOE emergency planning and response. Some unique
characteristics of hazardous biological agents are described
below:
· Threshold Quantities. Since biological agents differ
dramatically in terms of characteristics that determine their
ability to cause harm to humans, animals or plants, firm de
minimus hazard levels are difficult to discern. In addition, the
characteristics of available transport mechanisms for biological
agents make the definition of a general threshold screening value
even more difficult, if not impossible. Consequently, judging
the perceived risk associated with the release of a specific
agent involves an assessment of the agent characteristics and
activities conducted, irrespective of the volume or concentration
of agent involved.
The Select Agent Rules provide minimum quantities for
each HHS and Overlap hazardous biological toxin subject
to the regulations. These quantities establish de facto
minimum hazard levels for the toxins that determine
whether the toxin is subject to the requirements.
Similarly, minimum quantities should also represent
screening thresholds in the context of the DOE emergency
management system.
· Infection Control Concepts. Agent characteristics related
to the transfer of an agent from one human to another and the
capability of the agent to cause infection in a human are
important for emergency management planning for biological
agents, but are not applicable to other hazardous materials.
Because definitions of these terms vary, several were
specifically selected for this guide:
– Infectivity:
¡ Infection: detrimental colonization of a susceptible host
by a disease-causing microorganism (pathogen), where the
infecting microorganism seeks to enter and survive in a host and
to utilize the host's resources in order to multiply at the
host’s expense.
¡ Infectious: the capability [of a disease-causing
microorganism (pathogen)] of entering, surviving and multiplying
in a susceptible host.
¡ Infectivity: a relative measure of the capability with
which a disease-causing microorganism (pathogen) establishes an
infection in a susceptible host.
– Virulence:
¡ Virulent: the capability [of a disease-causing
microorganism (pathogen)] to rapidly overcome the natural
defenses of a host, causing a serious and injurious condition(s).
¡ Virulence: a relative measure of the capability of a
disease-causing microorganism (pathogen) to rapidly overcome the
natural defenses of a host, causing a serious and injurious
condition(s).
– Transmissibility:
¡ Transmission: the passing/transmitting of a disease from an
infected individual or group to a previously uninfected
individual or group. One or more of the following mechanisms may
transmit the disease-causing microorganism (pathogen) from one
person to another (person-to-person):
? Droplet contact - coughing or sneezing on another person
? Direct physical contact - touching an infected person
? Indirect contact - usually by touching a contaminated
surface
? Airborne transmission - if the microorganism can remain in
the air for long periods
? Fecal-oral transmission - usually from contaminated food or
water sources
? Vector-borne transmission - carried by insects or other
animals
¡ Transmissible: the capability [of a disease-causing
microorganism (pathogen)] to be passed person-to-person.
[Transmissible will also be used to describe a disease that is
transmitted person-to-person (i.e., transmissible disease)]
¡ Transmissibility: a relative measure of the capability with
which a disease-causing microorganism (pathogen) spreads person-
to-person.
· Measure of Severity. The DOE emergency management system
uses a Protective Action Criterion (PAC) as a measure of severity
for the airborne release of a radioactive or chemical hazardous
material. When the consequences of a release exceed their
respective PAC, adverse health effects are possible and
protective actions should be taken. (Cf. DOE G 151.1-2, Appendix
F.)
Individuals vary widely in their susceptibility to a
particular biological agent. For example, the ID
(Infectious Dose) for anthrax that results in disease in
10 percent of the population, ID10, is hundreds of
organisms. ID50 is tens of thousands and ID95 is
millions of organisms. Since the characteristics of IDs
for many agents do not reflect a delimiting value that
can be used to represent infectious vs. not infectious
doses or permissible vs. not permissible exposure levels,
a specific value of infectious dose will not be used in
DOE emergency management programs to measure release
severity (i.e., below a specific value, no protective
actions required vs. above the value, take actions.)
This position is supported in part by a study that asked
whether “infectious doses for organisms could be defined
in such a way to potentially develop permissible exposure
levels to those infectious agents.” The study concluded
that “. . . attempts to develop quantitative values for
human infectious dose are not currently feasible.” [OSHA
Infectious Dose White Paper, Applied Biosafety, Volume 8,
Number 4 (2003), pp. 160-165.]
Because no measure of severity is currently available for
use as a PAC for releases of hazardous biological
materials, DOE O 151.1C specifies that immediate
protective actions are required for any release of
biological agents and toxins outside of secondary
containment barriers.
· Amplification. Biological agents (bacteria, viruses) are
living organisms and have the ability to grow and multiply – to
amplify. The communicable nature of some biological agents means
that the amount may amplify and spread dramatically after it is
released to the environment. If a host is infected with a
communicable agent, it could be transmitted from host to host,
growing and multiplying within each infected subject.
This characteristic of living biological agents presents
an additional unique, and possibly unsolvable, challenge
for emergency management planning and response in
attempting to define a quantity of biological material
that represents a threat to collocated workers and the
public.
· Stability in the Environment. The persistence of hazardous
biological agents in the environment can vary dramatically among
different types of such organisms. Some viruses may survive in
the environment from minutes to hours, while some bacteria, such
as Bacillus anthracis, can transform into extremely stable
dormant spore forms under adverse conditions that can survive for
decades in the environment under adverse conditions. Stability
in the environment can influence specific initial protective
actions taken and the time duration for maintaining them.
· Incubation Period. The time between infection/uptake and
the onset of symptoms (i.e., incubation period), which can vary
from hours to days, may in some cases enable the facility staff
to analyze the event and perform lab tests and monitoring to
confirm that a suspected (e.g., observed through recognition
indicators) release has in fact occurred. Once confirmation
takes place, the incubation period can allow a window of
opportunity during which effective treatments can begin (prior to
onset) for individuals who may have been exposed.
However, the incubation period does not provide a similar
opportunity to reduce or eliminate further exposures.
Unless appropriate initial protective actions are
promptly implemented (e.g., access control,
decontamination, evacuations, etc.), the source of
biological material released during the event may
continue to expose workers or the public. This is
particularly true for the infected host, since some
infections are most transmissible during the incubation
time.
The incubation period is a mitigating (i.e., degrading)
factor in the timely detection of individuals who are
unknowingly infected or who do not report an exposure or
incident. Variability in symptom onset also makes it
difficult to establish the time of the release when
attempting to confirm that the release originated at the
facility.
· Detection Difficulties. Releases of biological agents are
difficult to detect directly and to identify with certainty in
real time. Various generic detection devices respond to the
presence of biological agents, but do not identify the specific
agent. Unlike radiation monitors and hazardous chemical
detection devices, real-time equivalent biological identification
devices currently available may not be feasible for use in DOE
biosafety facilities. Consequently, laboratory testing is
generally used to confirm the presence of biological agents,
although results can take up to several days to obtain.
Reliable detection of the onset of an outbreak of
infections, due to an unobserved release of a biological
agent from a DOE/NNSA facility, cannot be based solely on
the initial appearance of symptoms among site workers or
in the local community. A biological agent release could
be due to a natural outbreak or epidemic. Also, early
symptoms may appear to be the same as many non-lethal
diseases produced by common infectious agents.
3.3 Biological Operational Emergencies
The Select Agent Rules require immediate notifications to
CDC and/or APHIS upon discovery of “. . . a release of an
agent or toxin causing occupational exposure or release of a
select agent or toxin outside of the primary barriers of the
biocontainment area....” These criteria for notification of
CDC and/or APHIS Headquarters are consistent with the
fundamental objective of an OE categorization, namely, to
ensure prompt notifications to initiate a timely, effective
response. To maintain consistency with the Select Agent
Rules, the DOE Order and guidance incorporate, where
applicable and appropriate, concepts and requirements of the
rules. The DOE OE definition will supplement this general
condition for notifications of biological events with the
additional criterion that any actual or potential release of
a hazardous biological agent or toxin be “. . . outside of
the secondary barriers of the biocontainment area.” The
infectious nature of Select Agents and the lack of defined
de minimus hazard levels support OE declarations under
conditions that leave undefined a specific level of
consequences (and hence health effects) or the quantity
released into the environment.
The OE represents an actual or potential release beyond the
secondary barriers of the biocontainment area into the
environment. The environment may be the public area outside
of a laboratory contained within a facility or may refer to
releases directly outside a facility/building. Multiple
transport mechanisms can be associated with the OE.
Hazardous biological materials can be released to the
outside environment or can contaminate humans, vectors, and
fomite (i.e., inanimate objects such as clothing or
equipment), and then be carried outside the facility. In
the environment, they can persist in water systems and on
surfaces (including environmental matrices such as soil) and
again be transported by multiple mechanisms. Susceptible
hosts that contact contaminated air, water, or surfaces may
be vectors for further transmission of infectious biological
agents.
3.4 Biological Agent/Toxin Transport Mechanisms
In general, airborne transport and dispersion of hazardous
materials can have the greatest area of impact and require
the most time-urgent emergency response actions. This is
especially the case when source terms consist of large
quantities of hazardous materials and inhalation is the
primary receptor pathway. For hazardous chemicals and
radioactive materials, the spread of significant amounts of
contamination by animate or inanimate objects is often
easily detected and the initial area of contamination caused
by airborne dispersion predictable. Implementation or
recommendation of applicable protective measures to prevent
or limit worker or public exposures is straightforward.
Significant quantities of living biological agents
(microorganisms) can be transported as aerosols and by
additional transport mechanisms, including transmission from
an infected or contaminated host or object to one or many
other receptors. Biological agents can spread beyond their
point of initial release in air-handling systems, by the re-
aerosolization of contaminants (i.e., from floors and other
surfaces as a result of foot traffic or indoor air handling
systems; through adhesion to people or their clothing; and
by transmission from one person to another.) The result
could be widespread dispersal of contaminants (e.g., within
a building, into transportation and transit vehicles, into
homes or other sites.) Since no threshold or permissible
quantities have been established for biological agents,
transport mechanisms not normally considered or applicable
when hazardous chemicals and radioactive materials are
released should be evaluated for biological agents.
Biological toxins are non-living chemical materials produced
by living organisms. The transport mechanism for toxins is
basically the same as for particulate inorganic or organic
hazardous chemicals. However, because they represent
extremely toxic materials (poisons), release of even small
quantities from the facility as an aerosol, either to be
inhaled directly by receptors or to be deposited as
contamination, is of time-urgent concern.
Three general categories of transport mechanisms that should
be considered for hazardous biological materials:
1. Environmental dispersion
2. Infected host (agents only)
3. Contamination
Transport of hazardous biological materials from a facility
to external receptors in the environment can involve
combinations of several mechanisms. The specific paths
available will depend on facility design, geographic and
demographic characteristics of the surrounding area, and,
especially, characteristics of the biological agent. The
following sections contain brief discussions of these
transport mechanisms.
3.5 Environmental Dispersion
Two potential mechanisms for the transport and dispersal of
biological agents/toxins in the environment are airborne and
waterborne. Although many can be dispersed into the air and
transported as aerosols, most do not readily aerosolize in
their natural form. If the agent/toxin has been processed
to readily aerosolize (e.g., weaponized), then the airborne
dispersal of material could be the most likely mode of
transport with the greatest impact. The ability to
aerosolize is an individual agent/toxin characteristic and
may be modified dramatically by the formulation of material
containing the biological agent. This enhanced ability to
aerosolize should be specifically identified in analyzing
potential emergency scenarios. The ability of the
agent/toxin to survive in the environment after release
should also be assessed in determining the impact of a
release into the air. The aerosolized agent or toxin can
directly impact receptors through inhalation or other
pathways and/or by ingestion when receptors are exposed to
contaminated food products.
Some biological agents/toxins also have the ability to
remain viable in water and can pose a serious hazard if
released into wastewater or drinking water. The ability of
a particular agent/toxin to survive and remain a threat once
it enters a water supply needs to be considered.
3.6 Infected Host
A transport mechanism unique to biological agents is the
exposure of receptors (collocated workers or the public) to
a biological agent by an infected host. The infected host
moves from the facility to the environment and in the
environment to a receptor. The infected host transmits the
agent through direct or indirect contact with receptors.
This method of transport applies only to a subset of
hazardous biological agents referred to as transmissible
agents. These agents, such as the virus responsible for
smallpox or the bacteria that causes plague, can be
transmitted from one individual or animal to another, where
it can establish an infection, multiply, and be passed on to
other individuals or animals. Other types of hazardous
biological agents, such as the bacteria that cause anthrax,
are not transmitted directly from person to person. The
transmissibility of hazardous biological agents should be
established for any agent handled in a facility in order to
understand the potential consequences of a release to the
environment.
Transmissible diseases present the greatest potential danger
since they can result in epidemics and pandemics. The
Severe Acute Respiratory Syndrome (SARS) epidemic is a
recent example. This disease was initially detected in
poultry and was then transmitted to humans through close
contact. The disease then proved to be highly contagious
and lethal in humans. If small rodents or insects enter a
facility and become infected, they can infect humans and non-
humans. Infections can spread through droppings
(e.g., mouse droppings shed the Hanta Virus that becomes
aerosolized in dry, windy climates), biting (e.g., West Nile
Virus mosquitoes biting infected animals and then biting
other animals and humans), and contamination of food sources
outside the facility (e.g., deer droppings in fields have
contaminated vegetables with E. Coli.)
If a release of a hazardous biological agent to the
environment occurs via an infected host, such as a facility
worker or a vector (e.g., insects or rodents), the event
could go undetected until symptoms are recognized in one or
more individuals or animals as the result of infection.
Medical surveillance of facility workers, identification of
a disease outbreak by the local medical community, or
diagnosis of diseased domesticated or wild animals by
veterinarians may provide this recognition.
· Human Host – Infection of a human host by a biological agent
within a facility can occur due to an accident, such as a needle
stick, that penetrates PPE. Other mechanisms that can create an
infected host are also due to human errors, which could occur
where PPE is not used properly or safety precautions are not
followed. Once the human host is infected, the agent can grow
within its host and infect collocated workers and the public
through aerosolization (sneezing, coughing), direct physical
contact, or through foods (e.g., preparation process, sharing
food or utensils). Humans are highly effective carriers of some
transmissible agents and can be effective sources of
dissemination.
· Animal/Insect Hosts (Vectors) – Infected, live vectors
(i.e., non-human carriers) can spread vector-borne diseases.
Arthropod or rodent vectors, for example, that enter laboratory
spaces may become infected and carry an infectious agent out of
the facility. The most common vectors are arthropod hosts such
as mosquitoes, ticks or fleas. Rodents are the most likely
animal vectors (other than humans). Infected laboratory animals
that are the subjects of scientific investigations may transmit
the agent via direct contact, droppings, or being bitten by a
vector.
· Plant Host – As with human and animal diseases, infected
plants can spread disease to other plants. Plant bacterial,
viral, fungal, and protozoan pathogens can spread through direct
contact, proximity, or carrier/vector. Plant epidemics can have
severe economic consequences.
3.7 Contamination
Biological agents and toxins can also be transported outside
a biosafety facility through contamination. The
contamination mechanism for agents is only possible if the
agent can also survive in the environment for a time
sufficient to allow a receptor to become infected. Workers
in a biosafety facility may come into physical contact with
a biological agent and carry it outside the facility on
their skin or clothing, where it may be deposited or
transferred to suitable hosts and/or receptors. If an
infectious biological agent contaminates a surface
(e.g., skin, hair, clothing, objects) within the facility
that is potentially transportable to the outside, then
contamination should be considered as a transport mechanism.
It is possible for an insect or rodent to make contact with
a biological agent and carry it outside the facility.
Alternatively, insects or rodents could be exposed to the
agent outside the facility from another source. Objects
(i.e., fomite) within a facility may become contaminated
with a biological agent and transport the agent to receptors
outside the facility.
3.8 Biological Agent Release Scenarios
Analyses of OE releases of biological agents from a
biosafety facility will involve an understanding of the
characteristics of the agent, its formulation and use
(activities) in the laboratory, barriers and failure modes,
potential initiators of releases, mechanisms for transport
from the facility and in the environment, the external
environment, how the agent interacts with potential
receptors, and the medical indicators of infection. In the
context of OE releases of biological agents, the
“environment” might be the public area within the facility,
but outside the biocontainment area, where the specific
biosafety protocols associated with the agent/toxin are not
required.
In order to facilitate analyses, a simplified schematic
representation of scenario development is given in Figure 3-
1. The scenario sequence is divided into six groups of
parameters or components to be addressed:
1. Source
2. Failure(s)
3. Transport outside biocontainment area to the environment
4. Transport in the environment to the receptor
5. Agent-Receptor interactions
6. Effects on the receptor
The schematic shown in Figure 3-1 represents the sequence of
agent-activity-facility characteristics that may contribute
to a particular biological release scenario. The agent
needs to be specified in order to determine which
characteristics play a role in each step in the scenario.
As should be apparent, the figure is not to be interpreted
as a description of the parameters and considerations that
enter into the analysis of every biological agent release
scenario. The agent-activity-facility and scenario to be
analyzed will dictate the characteristics that will enter
into the analysis (e.g., barriers, transport mechanisms,
pathways, diagnosis indicators.)
Each potential release scenario has six basic components:
· Source. The source term for each scenario will depend on
the specific agent, its form/formulation (e.g., aerosolized) and
quantity (and concentration), and, if applicable, the specific
activity involving the agent that results in a release. Other
source terms may apply to scenarios involving initiators such as
natural phenomena or external events. The procedures and
protocols associated with use of the agent and its containment
status (e.g., in Class II BSC, PPE required, ventilation design)
will provide the characterization of the hazard required for
analysis.
The maximum planned quantity of material to be used by
the scientists/technicians will determine the upper
limits for emergency management analysis and the
potential release quantity to assume for planning
purposes, especially related to environmental dispersion
and contamination transport mechanisms. Although the
quantity in use will certainly influence the chance for
an exposure to occur, it will have little effect on pre-
planning for releases via an infected host transport
mechanism, given that an exposure has occurred.
· Failure(s). In DOE emergency management analyses of
hazardous material releases, barriers are physical or
administrative features that maintain each material in a safe
condition. The primary barrier is generally the one physically
nearest to the material to be controlled. In contrast, the BMBL
methodology for addressing biological containment uses the term
primary barrier more generally. Primary barriers are intended to
protect personnel and the immediate laboratory environment from
exposure to infectious biological agents. The biocontainment
area may consist of multiple primary barriers, with some barriers
having dual roles in preventing exposures both within the area
and outside in the environment (secondary barriers).
A postulated release of biological material will
usually involve failure of one of the primary barriers
(to be referred to as the initial barrier in this
guidance), while additional primary and secondary
barriers are intended to protect the personnel and the
immediate laboratory and to prevent release of material
outside the laboratory. Biocontainment barriers
intended to prevent releases of material are generally
consistent with emergency management terminology for
barriers. Significant exceptions are the PPE and
similar worker safety barriers that have a role as a
barrier to a biological release only for the infected
host transport mechanism.
Figure 3-1. Schematic Representation of Biological Release
Scenario
Potential failures associated with the barriers and
additional mitigating factors can represent variations in
the quantities of released material and expected
transport mechanisms associated with the specific
biological source term. Table 3-1 contains
representative examples of generic types of
barriers/controls and the primary agent transport
mechanism they may effectively prevent. Many of these
will become the barriers/controls and release conditions
or mitigating factors involved in the scenarios.
Table 3-1. Transport Mechanisms and Barriers/Controls
Barriers Transport Mechanisms to the
Environment
Environmental Infected Contaminat
Dispersion Host ion
Access control X X
Precautionary X X X
Safety Reminders
Decontamination X
Medical X
Surveillance
Physical X X
Containment
PPE X
Physical X X X
Separation(s)
Portal Design X X
Air Handling Design X X
As indicated in Figure 3-1 under Failure(s), a potential
release of biological materials will depend on the
initiator causing the failure of the initial barrier
(i.e., closest to the material), failures in additional
barriers or controls, and potential mitigating release
conditions. Further detailed discussions associated
with failure analysis and release scenarios are
contained in DOE G 151.1-2 Chapter 2, Hazards
Assessments, and will be discussed later in this Guide,
Section 4.2.
· Transport Outside Containment to the Environment. In this
step, the initiator(s) is specified for each failure mode, the
source term is estimated, and specific transport mechanisms that
apply to each initiator are identified. The agent release
scenario should specify how the agent is transported into the
environment from the facility. Each agent transport scenario
will provide an individual set of parameters that will contribute
to the analysis of the scenario.
· Transport in the Environment to the Receptor. Initial
transport of an agent out of the biocontainment area may continue
through a variety of mechanisms. For example, an environmental
dispersion of an agent out of the biocontainment area can result
in a host becoming infected outside or the contamination of a
vector that continues to spread the agent in the environment.
Thus, a release that may begin as a single transport mechanism
can eventually involve several candidate paths to a receptor.
This is indicated schematically in Figure 3-1.
· Agent-Receptor Interaction. The effects of agent-receptor
interactions depend on agent characteristics
(e.g., transmissibility, route of transmission, infectivity,
virulence), exposure level (i.e., dose), and available receptor
pathways and receptor susceptibility. These parameters may not
directly impact the analysis of the scenario, but can certainly
influence the selection of initial pre-planned protective
actions.
· Effects on Receptor. The final scenario characterization
step reflects potential effects of the agent and its associated
disease on the receptor. The resulting infection caused by a
specific agent could be recognized through consideration of the
characteristics shown in the figure. Hence, scenarios may
reflect releases that went unobserved at the facility, which
should now be recognized by onsite worker medical surveillance or
at offsite disease surveillance centers.
The brief introduction of the release scenario in this
section will be continued in this Guide, Section 4.2.
Scenarios form the basis for planning and response to OEs
involving biological agents. The purpose of the EPHA is
to analyze a spectrum of these scenarios to enable the
facility to recognize that an agent has been or might have
been released and to respond appropriately. The
recognition of OEs is introduced briefly in the next
section.
3.9 Recognizing Operational Emergencies
For emergency response measures to be effective, early
recognition of an actual or potential release of a
hazardous biological material is essential. Transition to
emergency operations depends on detection and recognition
of specific emergency event or condition
indicators/symptoms that suggest an actual or potential
release outside of secondary barriers. At any given time,
different indicators and symptoms may be monitored to
determine if facility conditions are normal or if any
abnormal event/ condition may have occurred. Monitoring
of these indicators and the recognition of the
significance of abnormalities is generally a routine
function of the biosafety facility staff.
Routine surveillance (cf. Section 2.5) should include an
“active” process that integrates and interprets the data
in the context of potential releases, rather than simply
as individual datum to be monitored, compared to expected
performance, and recorded. Methods employed to implement
detection and recognition of emergency events/ conditions
and to make the transition to emergency response should be
integrated with routine operational practices to the
greatest extent possible. Staff responsible for this
routine surveillance should be specifically trained to
perform this recognition function.
To implement an “active” recognition activity/function, an
emergency management program at a laboratory facility
should take advantage of control capabilities that are
already an integral part of good microbiological practices
and the biosafety program in the facility. Biosafety
control measures, such as routine surveillance activities,
are features of laboratory operations that could support
development of recognition factors for an emergency
management program. Requirements and criteria for
establishing a specific biosafety level and for
implementing a risk assessment methodology represent a
variety of measures intended to control the biological
agents or toxins contained within the laboratory. They
range from laboratory practices and equipment reflecting
direct control to routine surveillance activities
monitoring and maintaining expected performance of the
biosafety systems and at-risk personnel involved in the
work. These biosafety control measures are barriers to
the release of hazardous biological material, and, hence,
failure of one or more of these controls could result in a
release of an agent or toxin outside the laboratory via
one of the transport mechanisms.
Any site working with hazardous biological agents should
have an effective agent identification capability either
in-house or available on an as-needed basis from an
external source. Note, however, that it is not the intent
of this section to support the purchase of new equipment
or capabilities, if the current situation adequately
supports the needs of emergency response commensurate with
the hazards. Various technical methods are available for
detecting and identifying the presence of hazardous
biological materials. The surest method (the “gold
standard”) is laboratory analysis, which takes hours to
days, and is most appropriate as a confirmatory test and
not a real-time detection method. Other methods vary from
real-time generic (i.e., lacking specificity) detection to
various field and laboratory devices and methods that can
identify the presence of an agent in minutes to hours.
Some commercial detection and identification systems are
available and a number of others are being developed.
Simple antibody-based methods yield results in less than
15 minutes and are suitable for routine monitoring of
specific agents being used in a particular laboratory,
but, in general, they are limited in terms of throughput
and scope of agents detected. Antibody-based methods may
also lack specificity and sensitivity. More complex
nucleic acid-based systems are sensitive and specific.
However, the time to detect ranges from about 20 minutes
to several hours, and they are costly to operate and
maintain. In addition, nucleic acid-based systems are
limited in terms of throughput scope of agents detected.
Since the agents/toxins to be used or stored in a
biosafety facility will usually be known, it may be
possible to identify the specific detection methods needed
and to include these in emergency planning.
Note that the scenario components that may provide
recognition factors are indicated in Figure 3-1 associated
with two separate groups of scenario components, those
that may be directly observable at the facility and those
that are associated with manifestations of the infection
caused by the disease. This implies that two categories
of biological agent releases should be considered in
emergency management planning: observed and unobserved
releases. Recognition of observed releases will likely
occur at the facility, as the result of direct detection
of the release through observations of event indicators
(e.g., initiating event, barrier failure). In this case,
the agent will generally be known and response measures
can usually be initiated shortly after recognition of the
event.
In contrast, unobserved releases (e.g., unreported
infected host, contaminated vectors) could remain
undetected for a substantial period following the actual
event at the facility. Recognition of these events can
occur as the result of indirect detection of the release,
when infected receptor(s) present symptoms of the disease.
An active, ongoing medical surveillance program within the
DOE/NNSA community and in the local community can provide
an essential detection capability for identifying a
possible release from the facility. As with observed
releases, early recognition of an actual or potential
unobserved release of a biological agent is essential for
emergency response measures to be most effective.
3.10 Initial Protective Actions
Planning and developing initial protective actions for
biological agents and toxins require a coordinated effort
between DOE/NNSA site medical personnel and offsite public
health agencies. In the event of an OE at a biosafety
facility, it is expected that local and/or State public
health agencies will assume responsibility for initiating
long-term measures for protecting the local population,
including onsite workers, while the site will be
responsible for initiating prompt, initial protective
actions onsite and recommending protective actions
offsite. For an effective response, it is imperative that
site medical personnel coordinate protective action
planning with the local/State public health agency to
ensure that initial measures taken by the site or
recommendations made to offsite response organizations are
consistent with expectations of local/State public health
authorities, as different public health jurisdictions may
have different capabilities.
The specific initial protective actions to be taken will
depend upon a number of factors (indicated schematically
in Figure 3-1), including:
· Transport mechanism of the release (i.e., airborne, infected
host, contamination)
· Observed vs. unobserved release
· Characteristics of the biological agent released
(e.g., transmissibility, infectivity, stability in the
environment)
· Location of populations in relation to the source of
biological agents/toxins
· The time available to issue and take protective actions
Initial protective actions that can be taken in the event
of a biological OE release are general measures that can
apply to many observed releases of hazardous
agents/toxins. These measures may include:
1.Access control: Control of personnel access to areas of
potential exposure and/or contamination outside the
biocontainment area to prevent unnecessary exposures and
minimize the spread of contamination. Access control is
most effective when implemented immediately upon
recognizing that an area has been, or will be, affected
by a hazardous material release.
2.Sheltering/Shelter-in-place: Directing people to seek
shelter inside a building or similar location and to
remain inside until the threat of exposure at dangerous
levels passes. Shelter-in-place means directing people
to stay inside at their current locations until the
threat of dangerous exposure passes. Sheltering/shelter-
in-place is used when evacuating collocated workers
and/or the public would cause greater risk than staying
where they are or when an evacuation cannot be
performed. Identification of areas for sheltering with
potential isolation capacity should be considered.
3.Evacuation: Moving all people from a threatened area to
a safer place. To perform an evacuation, there should
be enough time for people to be warned, to prepare, and
to leave an area. Evacuees should be sent to a definite
place, by a specific route, far enough away from the
incident site so they will not have to be moved again if
the wind shifts. Consideration should be given to
development of a default radius around the facility
based on wind speed and a 1- to 2-hour time span after
the release, to define the area of immediate concern.
4.Decontamination: Removal of hazardous material from
personnel and equipment to the extent necessary to
prevent potential adverse health effects. Contaminated
clothing and equipment should be removed after use and
stored in a controlled area until cleanup procedures can
be initiated. In some cases, protective clothing and
equipment cannot be decontaminated and needs to be
disposed of in the proper manner. Decontamination also
applies to removal of hazardous materials that may have
been deposited on the ground and on other structures in
the vicinity of the release. Use of disinfectants on
people or material is a form of decontamination.
5.Medical Surveillance: Immediate and active medical
surveillance activities, including a process to
identify, screen, test, and assess people most likely to
have been exposed. Based on medical surveillance
results, identify candidates for continued monitoring
and/or treatment.
6.Quarantine: Separation and restriction of movement of
persons, who while not yet ill, have been exposed to a
transmissible biological agent and therefore may become
infectious. Since quarantine may sometimes require long
periods of time pending definitive laboratory results,
considerations for support of personnel may include
food, water and diversionary activities.
Several longer term protective actions may also be
initiated soon after a biological OE release has been
identified, such as:
7. Vector control: Management of vectors by reducing or
eliminating their populations and chances of disease
transmission; or reducing or eliminating their ability to cause
harm. For most scenarios, vector control may be considered a
long-term protective action.
8. Control/Disinfection of Contaminated Water Supplies:
Shutting off contaminated water supply and water supply intake
points to prevent contaminated water usage. This decision may be
based on recommendations of appropriate health or agricultural
agencies. Water supplies may be restricted at the point of
origin or distribution, confiscated, stored, or destroyed.
Destruction or neutralization (disinfection) of disease-carrying
microorganisms in contaminated water supplies (lakes, reservoirs,
tanks, ponds, etc.) may be conducted to restore them to use.
9. Control of Contaminated Food Products: The embargoing or
destroying of contaminated agricultural products is appropriate
to control the physical movement of food products both raw and
processed in an affected area (animal, dairy, plant). This
decision may be based on recommendations of the appropriate
health or agricultural agencies.
10. Changes in Livestock and Agricultural Practices:
Contamination of pastures and agricultural areas due to
deposition of released materials can require specific protective
actions to minimize introduction of contamination into the human
food chain. Actions could include putting livestock on stored
feed, delaying slaughter of animals until the hazardous material
has been removed from their systems, and treating soil to
minimize uptake of the hazardous material into foodstuffs. Use
of severely contaminated land for agricultural purposes may have
to be prohibited.
In the case of an unobserved release, the source may not
be confirmed for sometime after recognition (of disease
outbreak) and initial protective actions may not be
employed until sometime after the release event. However,
many of the above measures (e.g., medical surveillance,
access control, decontamination) should be considered when
any actual or potential release from a biosafety facility
is recognized.
In general, for either an observed or unobserved release,
State or local public health officials specify long-term
protective action criteria and associated measures to be
implemented both onsite and offsite. These measures are
often agent-specific, reflecting the different agent
characteristics (e.g., transmissibility, incubation
period, stability, available hosts, and affected species),
facility design, and geographic and demographic
characteristics of the surrounding area. For example, a
high concentration of material coupled with additional
risk factors, such as high potential for airborne
transmission and a high infectivity, virulence, and
lethality, should elevate the protective actions
necessary.
For an effective response, it is imperative that site
medical personnel coordinate protective action planning
with local/State public health agencies to ensure initial
measures taken by the site or recommendations made to
offsite response organizations have been agreed upon and
can be seamlessly integrated with the public health
response. Because public health jurisdictional knowledge
and experience may vary, onsite emergency managers may
have to provide technical agent expertise necessary to
determine appropriate protective actions.
The protective actions indicated above do not directly
address worker safety requirements, an integral part of
biosafety response to an occupational accident within the
laboratory (e.g., hand washing, handling equipment,
showering on exiting the laboratory, PPE). In the event
of an incident or OE, the laboratory workers will
implement the facility-specific BSL program safety
protocols. Development of these protocols is the
responsibility of each DOE/NNSA biosafety facility and
will not be addressed in this version of DOE G 151.1-5.
Similarly, specific protective action requirements for
initial responders will be left to facility and response
organizations to identify and address as part of the
planning process.
3.11 Public Health Response
A primary function of local, State, and Tribal public health
agencies is to provide a capability for identifying a
“communicable disease emergency” in communities for which
they are responsible and for responding with measures to
confine and arrest the spread of the disease. In this
capacity, public health assets will play a major role in
response to a release of hazardous biological materials from
a DOE/NNSA biosafety facility. Whether a release is
strictly onsite or involves an offsite impact, public health
will ultimately assume primary responsibility for ensuring
that the community is protected from further exposure.
Local, State, or Federal public health response falls into
three categories, which represent a graded approach6:
1.Continuous Medical Surveillance. Continuous medical
surveillance, a primary community public health function,
is a routine activity performed by public health
professionals who monitor incoming disease reporting data
for indicators and patterns to determine whether a
communicable disease emergency is imminent. State-based
public health departments provide a central
communications point for ongoing surveillance, disease
reporting, and epidemiological investigations. These
departments also serve as repositories for agent-specific
knowledge. Routine disease reporting, which is both
mandated and regulated, originates from medical
facilities, clinics, laboratories, and private clinician
offices. These diseases usually have potential for a
broad community impact (e.g., pertussis) and necessitate
a public health response. Surveillance efforts have been
increased and broadened in both the public health and
medical communities to include rapidly emerging
infectious illnesses (e.g., SARS, avian and pandemic
influenzas).
2.Active Investigation. Active investigation is a routine
public health practice initiated by a positive
surveillance event. Active investigations occur on a
daily basis as public health professionals interpret
incoming data from reports or direct observations. As a
result, they make professional judgments on the scope of
further actions based on potential impact and anticipated
severity.
3.Emergency Response. Initiated by public health
organizations to mitigate an unusual public health
occurrence, emergency response actions can include
broader epidemiological investigations, medical screening
and laboratory sampling, mass prophylaxis/vaccination,
isolation/quarantine, public information and risk
communication, hazards/site remediation, and legal
involvement. Local public health departments may lack
the personnel to support a robust surge response capacity
and will need to be linked to regional assets and the
State public health agency. Emergency response will vary
depending on locale, population affected, and relative
hazard as perceived by the local public health officer
with legal authority.
DOE/NNSA site emergency managers should become familiar with
local and State public health capabilities. They should
coordinate and reach agreement on sole and shared
responsibilities in order to coordinate efforts during an
observed release OE at the biosafety facility, or in
response to an identified communicable disease emergency
that can be associated with an unobserved release OE at the
facility. To enhance Departmental response capabilities,
DOE/NNSA biosafety facilities should provide agent-specific
data to local public health agencies as part of pre-
planning.
Following an OE declaration, DOE/NNSA emergency managers
should expect to provide agent and procedure- /protocol-
specific information and personnel accountability data; and
should have pre-planned methodologies in place for: 1) rapid
identification of potentially exposed personnel; and, 2)
isolation for medical screening and treatment purposes. To
ensure an integrated response, plans should be developed in
coordination with the appropriate public health agencies by
providing symptom-specific awareness training for all
personnel and maintaining a central reporting process for
ongoing medical surveillance. The public health and medical
communities will likely look to the DOE/NNSA biosafety
facility to provide expert level professionals familiar with
facility-specific agents and to initiate an active,
systematic monitoring program and response protocols
addressing DOE/NNSA personnel tracking and epidemiological
investigations.
4. EMERGENCY MANAGEMENT PROGRAM FOR BIOSAFETY FACILITIES:
TECHNICAL PLANNING BASES
The Emergency Management Program for a DOE/NNSA facility can
consist of two components: an Operational Emergency Base
Program and an Operational Emergency Hazardous Material
Program. Each DOE facility/site or activity is required by
DOE O 151.1C to have an Operational Emergency Base Program,
which provides the framework for response to serious events
or conditions that involve the health and safety of workers
and the public, the environment, and safeguards and
security. Although DOE O 151.1C establishes several DOE-
unique requirements and a minimum set of generic
requirements for the Base Program, the framework for
response results mainly from the implementation of the
requirements of DOE regulations, other DOE orders, and
applicable non-DOE Federal, Tribal, State, and local
laws/regulations/ordinances. The specific requirements that
constitute the Operational Emergency Base Program are the
emergency planning and preparedness aspects of these Orders
and laws/regulations/ordinances. Examples of emergency
response features addressed in other DOE Orders and
laws/regulations/ ordinances include: medical support,
worker evacuation plans, fire drills, worker notification
systems, hazardous material communication, contingency
planning for oil spills, environmental spill drills and
exercises, and DOE security and safeguards requirements.
The objective of the Base Program is to achieve an effective
integration of emergency planning and preparedness
requirements into an emergency management program that
provides capabilities for all-emergency response, through
communication, coordination, and an efficient and effective
use of resources.
DOE O 151.1C requires that emergency management planning
efforts begin with identification of facility-hazards and
that the scope and extent of emergency planning and
preparedness be commensurate with these hazards. The
Hazards Survey identifies key components that provide a
foundation of basic emergency management requirements and an
integrated framework for response to serious events
involving health and safety and the environment. Much of
the information in the Hazards Survey should already be
collected in the course of meeting other DOE, NNSA, and
Federal, Tribal, State, and local authority requirements.
The Hazards Survey is required by all