ASTM E2770-17
(Guide)Standard Guide for Operational Guidelines for Initial Response to Suspected Biological Agents and Toxins
Standard Guide for Operational Guidelines for Initial Response to Suspected Biological Agents and Toxins
SIGNIFICANCE AND USE
5.1 Community knowledge and experience related to emergency response to threats with a biological agent or toxin at the Federal, State, tribal, and local levels has been translated into a standard guide to assist responder agencies’ progress toward the goal of building operational guidelines for the sample collection and response to a potential biological agent or toxin. The guide is intended to enhance the ability, knowledge, and communication between emergency response team representatives, including fire department, HAZMAT, local law enforcement, Federal Bureau of Investigation, and public health personnel as well as other responders that are responsible for responding to a threat incident involving a biological agent or toxin, or both.
5.2 This guide supports, and should be utilized as an accompaniment to standard sample collection methods (for example, Practices E2458). Standard guidance insures reduced exposure risk, minimizes on-site sample consumption for preservation of public health samples and forensic samples, reduces variability associated with sample handling, and analysis, and increases the reliability of the sampling procedure when collecting a sample of suspect biological agents and toxins.
5.3 Development of this standard was at the request and with considerable contributions from the public health and first responder communities in the United States to facilitate collection and evaluation of potential biological agents and toxins in the field.
5.4 This guide should be incorporated as a reference in Emergency Operation Centers (EOCs), emergency operations plans (EOPs) and Multiagency Coordination Systems (MACS) to assist in policy formation and development of strategic objectives consistent with the needs of the Incident Commander (IC).
5.5 Documents developed from this standard guide should be referenced and revised as necessary and reviewed on a two-year cycle (at a minimum). The review shall consider new and updated requirements and ...
SCOPE
1.1 This guide provides considerations for decision-makers when responding to incidents that may involve biological agents and toxins. This guide provides information and guidance for inclusion in response planning, on activities to conduct during an initial response to an incident involving suspected biological agents or toxins, or both.
1.2 This guide delineates fundamental requirements for developing a sampling and screening capability for biological agents or toxins, or both, within a jurisdiction, practice, or operational area to assure proper involvement, communication, and coordination of all relevant agencies.
1.3 This guide applies to emergency response agencies that have a role in the initial response to unknown threats that are suspected biological agents and toxins. This guide is designed for but not limited to emergency response services such as law enforcement, fire departments, hazardous materials, public health, and emergency management.
1.4 This guide assumes implementation begins well before the recognition of an event with a suspected biological agent or toxin, or both, and ends when emergency response actions cease or the response is assumed by federal response teams.
1.5 This guide utilizes risk-based response architecture and the guidance as described in the National Response Framework and is intended to be coupled with the authority having jurisdiction's (AHJs) understanding of local vulnerabilities and capabilities when developing its plans and guidance documents on response to incidents involving a suspected biological agent or toxin, or both.
1.6 This guide is compliant with the National Incident Management System (NIMS) and uses Incident Command System (ICS) common terminology. Full compliance with NIMS is recognized as an essential part of emergency response planning. In developing this standard, every effort was made to ensure that all communications between organizational elem...
General Information
- Status
- Published
- Publication Date
- 31-Mar-2017
- Technical Committee
- E54 - Homeland Security Applications
- Drafting Committee
- E54.01 - CBRNE Detection and CBRN Protection
Relations
- Effective Date
- 01-Oct-2023
- Effective Date
- 01-Aug-2018
- Effective Date
- 01-Aug-2018
- Effective Date
- 01-Feb-2018
- Effective Date
- 01-Nov-2017
- Effective Date
- 01-Jul-2011
- Effective Date
- 01-Jul-2011
- Effective Date
- 01-Oct-2010
- Effective Date
- 01-Jul-2008
- Effective Date
- 01-Jun-2006
- Effective Date
- 01-Mar-2005
- Effective Date
- 01-Mar-2005
- Effective Date
- 01-Apr-2017
- Effective Date
- 01-Apr-2017
- Effective Date
- 01-Apr-2017
Overview
ASTM E2770-17: Standard Guide for Operational Guidelines for Initial Response to Suspected Biological Agents and Toxins provides a comprehensive framework to assist emergency responder agencies in preparing for, coordinating, and conducting an initial response to incidents involving potential biological agents or toxins. Developed with extensive input from the public health and first responder communities, this guide serves as a reference for agencies tasked with managing potential biological threats at the federal, state, tribal, and local levels, with an emphasis on interagency communication, safety, and standardized procedures.
The standard is intended for use by fire departments, HAZMAT teams, law enforcement, the FBI, public health officials, and other emergency responders. It is fully compliant with the National Incident Management System (NIMS) and the Incident Command System (ICS), ensuring integration with established emergency management protocols.
Key Topics
Incident Response Planning
The standard emphasizes the importance of coordinated planning before an event occurs and provides considerations for including response activities in emergency operations plans and multiagency coordination systems.Sampling and Screening Capability
ASTM E2770-17 outlines the foundational requirements needed to establish and maintain effective sampling and screening procedures for suspected biological agents or toxins. It supports the adoption of standard sample collection methods, such as those in ASTM E2458.Roles and Responsibilities
The guide details the involvement of key agencies-including local and federal law enforcement, public health, hazardous materials response teams, and supporting organizations-in every phase of an incident response.Risk-Based Response and Assessment
The framework incorporates risk assessments and hazard evaluations as primary steps in the response process, consistent with DHS and CDC guidance.Responder Training and Competency
Guidance is provided for the development of training programs that meet recognized standards (e.g., NFPA 472, OSHA 29 CFR 1910.120) with ongoing competency assessments and proficiency testing.Personal Protective Equipment (PPE) Guidance
The standard offers recommendations for selecting and using PPE during initial response and sample collection, in alignment with relevant federal and industry requirements.Documentation and Chain of Custody
Detailed protocols for documentation and chain-of-custody maintenance ensure integrity from sample collection to laboratory analysis.
Applications
Emergency Operations Centers (EOCs)
Use the guide as a key reference when designing or updating emergency response plans and policies relating to biothreat response.Responder Agencies
Implement consistent, risk-based protocols for the safe and effective collection and handling of biological agent and toxin samples.Interagency Communication
Improve knowledge sharing and operational coordination among fire, law enforcement, HAZMAT, public health, and federal agencies during biological incident responses.Training Programs
Develop or update responder training and assessment programs to address current best practices, technologies, and regulatory requirements relevant to biological incident management.Strategic Planning
Assist decision-makers at the jurisdictional level in policy development, resource allocation, and coordination efforts for suspected biological agent or toxin incidents.Hazard Mitigation and Public Health Protection
Minimize responder and public exposure risks, ensure sample integrity, and maintain the reliability of laboratory analyses during the initial response phase.
Related Standards
- ASTM E2458: Practices for Bulk Sample Collection and Swab Sample Collection of Visible Powders Suspected of Being Biothreat Agents from Nonporous Surfaces
- NFPA 472: Standard for Competence of Responders to Hazardous Materials/Weapons of Mass Destruction Incidents
- OSHA 29 CFR 1910.120: Hazardous Waste Operations and Emergency Response (HAZWOPER) Standard
- National Incident Management System (NIMS)
- ISO/IEC 17043: Conformity Assessment - General Requirements for Proficiency Testing
ASTM E2770-17 is a vital resource for any organization tasked with the initial response to suspected biological threats, providing best practices that reinforce readiness, safety, and effective incident management within a standardized operational framework.
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Frequently Asked Questions
ASTM E2770-17 is a guide published by ASTM International. Its full title is "Standard Guide for Operational Guidelines for Initial Response to Suspected Biological Agents and Toxins". This standard covers: SIGNIFICANCE AND USE 5.1 Community knowledge and experience related to emergency response to threats with a biological agent or toxin at the Federal, State, tribal, and local levels has been translated into a standard guide to assist responder agencies’ progress toward the goal of building operational guidelines for the sample collection and response to a potential biological agent or toxin. The guide is intended to enhance the ability, knowledge, and communication between emergency response team representatives, including fire department, HAZMAT, local law enforcement, Federal Bureau of Investigation, and public health personnel as well as other responders that are responsible for responding to a threat incident involving a biological agent or toxin, or both. 5.2 This guide supports, and should be utilized as an accompaniment to standard sample collection methods (for example, Practices E2458). Standard guidance insures reduced exposure risk, minimizes on-site sample consumption for preservation of public health samples and forensic samples, reduces variability associated with sample handling, and analysis, and increases the reliability of the sampling procedure when collecting a sample of suspect biological agents and toxins. 5.3 Development of this standard was at the request and with considerable contributions from the public health and first responder communities in the United States to facilitate collection and evaluation of potential biological agents and toxins in the field. 5.4 This guide should be incorporated as a reference in Emergency Operation Centers (EOCs), emergency operations plans (EOPs) and Multiagency Coordination Systems (MACS) to assist in policy formation and development of strategic objectives consistent with the needs of the Incident Commander (IC). 5.5 Documents developed from this standard guide should be referenced and revised as necessary and reviewed on a two-year cycle (at a minimum). The review shall consider new and updated requirements and ... SCOPE 1.1 This guide provides considerations for decision-makers when responding to incidents that may involve biological agents and toxins. This guide provides information and guidance for inclusion in response planning, on activities to conduct during an initial response to an incident involving suspected biological agents or toxins, or both. 1.2 This guide delineates fundamental requirements for developing a sampling and screening capability for biological agents or toxins, or both, within a jurisdiction, practice, or operational area to assure proper involvement, communication, and coordination of all relevant agencies. 1.3 This guide applies to emergency response agencies that have a role in the initial response to unknown threats that are suspected biological agents and toxins. This guide is designed for but not limited to emergency response services such as law enforcement, fire departments, hazardous materials, public health, and emergency management. 1.4 This guide assumes implementation begins well before the recognition of an event with a suspected biological agent or toxin, or both, and ends when emergency response actions cease or the response is assumed by federal response teams. 1.5 This guide utilizes risk-based response architecture and the guidance as described in the National Response Framework and is intended to be coupled with the authority having jurisdiction's (AHJs) understanding of local vulnerabilities and capabilities when developing its plans and guidance documents on response to incidents involving a suspected biological agent or toxin, or both. 1.6 This guide is compliant with the National Incident Management System (NIMS) and uses Incident Command System (ICS) common terminology. Full compliance with NIMS is recognized as an essential part of emergency response planning. In developing this standard, every effort was made to ensure that all communications between organizational elem...
SIGNIFICANCE AND USE 5.1 Community knowledge and experience related to emergency response to threats with a biological agent or toxin at the Federal, State, tribal, and local levels has been translated into a standard guide to assist responder agencies’ progress toward the goal of building operational guidelines for the sample collection and response to a potential biological agent or toxin. The guide is intended to enhance the ability, knowledge, and communication between emergency response team representatives, including fire department, HAZMAT, local law enforcement, Federal Bureau of Investigation, and public health personnel as well as other responders that are responsible for responding to a threat incident involving a biological agent or toxin, or both. 5.2 This guide supports, and should be utilized as an accompaniment to standard sample collection methods (for example, Practices E2458). Standard guidance insures reduced exposure risk, minimizes on-site sample consumption for preservation of public health samples and forensic samples, reduces variability associated with sample handling, and analysis, and increases the reliability of the sampling procedure when collecting a sample of suspect biological agents and toxins. 5.3 Development of this standard was at the request and with considerable contributions from the public health and first responder communities in the United States to facilitate collection and evaluation of potential biological agents and toxins in the field. 5.4 This guide should be incorporated as a reference in Emergency Operation Centers (EOCs), emergency operations plans (EOPs) and Multiagency Coordination Systems (MACS) to assist in policy formation and development of strategic objectives consistent with the needs of the Incident Commander (IC). 5.5 Documents developed from this standard guide should be referenced and revised as necessary and reviewed on a two-year cycle (at a minimum). The review shall consider new and updated requirements and ... SCOPE 1.1 This guide provides considerations for decision-makers when responding to incidents that may involve biological agents and toxins. This guide provides information and guidance for inclusion in response planning, on activities to conduct during an initial response to an incident involving suspected biological agents or toxins, or both. 1.2 This guide delineates fundamental requirements for developing a sampling and screening capability for biological agents or toxins, or both, within a jurisdiction, practice, or operational area to assure proper involvement, communication, and coordination of all relevant agencies. 1.3 This guide applies to emergency response agencies that have a role in the initial response to unknown threats that are suspected biological agents and toxins. This guide is designed for but not limited to emergency response services such as law enforcement, fire departments, hazardous materials, public health, and emergency management. 1.4 This guide assumes implementation begins well before the recognition of an event with a suspected biological agent or toxin, or both, and ends when emergency response actions cease or the response is assumed by federal response teams. 1.5 This guide utilizes risk-based response architecture and the guidance as described in the National Response Framework and is intended to be coupled with the authority having jurisdiction's (AHJs) understanding of local vulnerabilities and capabilities when developing its plans and guidance documents on response to incidents involving a suspected biological agent or toxin, or both. 1.6 This guide is compliant with the National Incident Management System (NIMS) and uses Incident Command System (ICS) common terminology. Full compliance with NIMS is recognized as an essential part of emergency response planning. In developing this standard, every effort was made to ensure that all communications between organizational elem...
ASTM E2770-17 is classified under the following ICS (International Classification for Standards) categories: 13.300 - Protection against dangerous goods. The ICS classification helps identify the subject area and facilitates finding related standards.
ASTM E2770-17 has the following relationships with other standards: It is inter standard links to ASTM E2601-23, ASTM F2412-18a, ASTM F2413-18, ASTM F2412-18, ASTM F2413-17, ASTM F2413-11, ASTM F2412-11, ASTM E2458-10, ASTM E2601-08, ASTM E2458-06, ASTM F2413-05, ASTM F2412-05, ASTM E3095-17, ASTM E2458-17, ASTM E2852-13(2021). Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
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Standards Content (Sample)
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: E2770 − 17
Standard Guide for
Operational Guidelines for Initial Response to Suspected
Biological Agents and Toxins
This standard is issued under the fixed designation E2770; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
Athreat with a biological agent or toxin is a serious matter that affects public health, public safety,
the economy and the general confidence of the people. The National Strategy for Homeland Security
and its National Response Framework focuses homeland security efforts on preventing and disrupting
terrorist attacks, protecting the American people, our critical infrastructure and key resources, and
responding to and recovering from incidents that do occur while continuing to strengthen the
foundation of our nation. As laid out by the National Response Framework, a coordinated and
synchronous response to suspected acts of bio-terrorism requires advance planning, including the
equipping and training of emergency responders prior to an incident. The goal of this standard guide
istosupportnationalstandardsforrespondingtoandcollectingsuspectedbiologicalagentsandtoxins
with guidance centered on coordination among representatives of emergency response teams,
including hazardous materials response teams, law enforcement, public health, including the Centers
for Disease Control and Prevention (CDC) national Laboratory Response Network (LRN), and the
Federal Bureau of Investigation (FBI). This standard guide provides uniform guidance that covers all
of the following components: response planning, responder training, competency evaluation,
proficiency testing, concept of operations, hazard assessment, threat evaluation, sample collection,
field screening, risk communication and documentation for responding to an incident suspected of a
biological agent or toxin, or both.
1. Scope for but not limited to emergency response services such as law
enforcement, fire departments, hazardous materials, public
1.1 This guide provides considerations for decision-makers
health, and emergency management.
when responding to incidents that may involve biological
agents and toxins. This guide provides information and guid-
1.4 This guide assumes implementation begins well before
ance for inclusion in response planning, on activities to
therecognitionofaneventwithasuspectedbiologicalagentor
conduct during an initial response to an incident involving
toxin, or both, and ends when emergency response actions
suspected biological agents or toxins, or both.
cease or the response is assumed by federal response teams.
1.2 This guide delineates fundamental requirements for
1.5 This guide utilizes risk-based response architecture and
developing a sampling and screening capability for biological
theguidanceasdescribedintheNationalResponseFramework
agents or toxins, or both, within a jurisdiction, practice, or
and is intended to be coupled with the authority having
operationalareatoassureproperinvolvement,communication,
jurisdiction’s(AHJs)understandingoflocalvulnerabilitiesand
and coordination of all relevant agencies.
capabilitieswhendevelopingitsplansandguidancedocuments
1.3 This guide applies to emergency response agencies that
on response to incidents involving a suspected biological agent
have a role in the initial response to unknown threats that are
or toxin, or both.
suspected biological agents and toxins. This guide is designed
1.6 This guide is compliant with the National Incident
Management System (NIMS) and uses Incident Command
1 System (ICS) common terminology. Full compliance with
This guide is under the jurisdiction of ASTM Committee E54 on Homeland
Security Applications and is the direct responsibility of Subcommittee E54.01 on
NIMSisrecognizedasanessentialpartofemergencyresponse
CBRNE Sensors and Detectors.
planning. In developing this standard, every effort was made to
Current edition approved April 1, 2017. Published May 2017. Originally
ensure that all communications between organizational ele-
approved in 2010. Last previous edition approved in 2010 as E2770 – 10. DOI:
10.1520/E2770-17. ments during an incident are presented in plain language
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E2770 − 17
according to NIMS 2008. In keeping with this NIMS NIMS 2008 National Incident Management System
requirement,keydefinitionsandterms,usingplainEnglish,are Planning Guidance for Recovery Following Biological
incorporated. Incidents,BiologicalDecontaminationStandardsWorking
Group, Subcommittee on Decontamination Standards and
1.7 This guide does not purport to address all of the safety
Technology Committee on Homeland and National
concerns, if any, associated with its use. It is the responsibility
Security, National Science and Technology Council, May
of the user of this standard to establish appropriate safety and
health practices and determine the applicability of regulatory
NRF 2008 National Response Framework
limitations prior to use.
OSHA - CPL 02-02-073 Inspection Procedures for 29 CFR
1.8 This international standard was developed in accor-
1910.120 and 1926.65, Paragraph (q): Emergency Re-
dance with internationally recognized principles on standard-
sponse to Hazardous Substance Releases
ization established in the Decision on Principles for the
EPA - Safety, Health, and Environmental Management
Development of International Standards, Guides and Recom-
(SHEM) Guide No. 44 Personal Protective Equipment,
mendations issued by the World Trade Organization Technical
October 2004
Barriers to Trade (TBT) Committee.
EPA - Safety, Health, and Environmental Management
(SHEM) Guideline No. 46 Respiratory Protection, dated
2. Referenced Documents
October 2004
2.1 ASTM Standards:
EPA - Order 1460.1 Occupational Medical Surveillance
E2458 Practices for Bulk Sample Collection and Swab
Program, June 18, 1996
Sample Collection ofVisible Powders Suspected of Being
EPAAll Hazards Receipt Facility Screening Protocol (EPA/
Biothreat Agents from Nonporous Surfaces 5
600/R-08/105) September 2008
E2601 Practice for Radiological Emergency Response
NIOSH Publication No. 2009-132 Recommendations for the
F2412 Test Methods for Foot Protection
Selection and Use of Respirators and Protective Clothing
F2413 Specification for Performance Requirements for Pro-
for Protection Against Biological Agents
tective (Safety) Toe Cap Footwear
FBI Laboratory Publication: Handbook of Forensic Services
2.2 Federal Government Regulations:
18 USC 178 Definitions
DOT, current version, Emergency Response Guidebook
18 USC 1038 False Information and Hoaxes
(ERG)
DOT - 49 CFR, Parts 171-180 Hazardous Materials Regu-
CDC/NIOSH Surface Sampling Procedures for Bacillus an-
lations
thracis Spores from Smooth, Non-porous Surfaces, April
DOT - 49 CFR 172, Subpart H Transportation Training
26, 2012
DOT - 49 CFR 173 General Requirements for Shipments
DHS – Framework for a Biothreat Field Response Mission
and Packaging
Capability, April 2011
DOT - 49 CFR 178 Specifications for Packaging
2.4 NFPA Standards:
EPA - 40 CFR 300 National Oil and Hazardous Substances
NFPA 472 Standard for Competence of Responders to Haz-
Pollution Contingency Plan (NCP)
ardous Materials/Weapons of Mass Destruction Incidents,
EPA - 40 CFR 311 Worker Protection
2008 Edition
NRC-10CFR20 StandardsforProtectionagainstRadiation
NFPA1994 StandardonProtectiveEnsemblesforChemical/
NIOSH - 42 CFR 84 Respiratory Protective Devices
Biological Terrorism Incidents
OSHA- 29 CFR 1910 Subpart Z and 29 CFR 1926 Subpart
NFPA 1600 Standard on Disaster/Emergency Management
Z Toxic and Hazardous Substances
and Business Continuity/Continuity of Operations
OSHA- 29 1910.1096 and 29 CFR 1926.53 Ionizing Radia-
Programs, 2016 Edition
tion
2.5 IATA Standards:
OSHA- 29 CFR 1910.120 Hazardous Waste Operations and
IATA PI 602 Infectious Diseases (Infectious Substances)
Emergency Response (HAZWOPER) standard
IATA PI 650 Shipping of Diagnostic Samples
OSHA - 29 CFR 1910 Subpart I (Sections 132 to 139) Per-
IATA DGR 46th Edition 2005
sonal Protective Equipment
IATA DGR Addendum I January 2005
OSHA - 29 CFR 1910.1200 Hazard Communication
2.3 Federal Guidance:
FBI-DHS-HHS/CDC Coordinated Document, Guidance on
Available from Federal Emergency Management Agency (FEMA), 500 C St.,
Initial Response to a Suspicious Letter/Container with a
SW, Washington, DC 20472, http://www.fema.gov.
Potential Biological threat, November 2, 2004.
Available from Environmental Protection Agency (EPA), 1200 Pennsylvania
Ave, NW, Washington, DC 20460, http://nepis.epa.gov.
Available from http://HAZMAT.dot.gov/pubs/erg/gydebook.htm.
2 7
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from http://www.cdc.gov/niosh/topics/emres/surface-sampling-
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM bacillus-anthracis.html.
Standards volume information, refer to the standard’s Document Summary page on Available from http://www.hsdl.org/?view&did=767721.
the ASTM website. Available from National Fire Protection Association (NFPA), 1 Batterymarch
AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments, Park, Quincy, MA 02169-7471, http://www.nfpa.org.
732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http:// AvailablefromtheInternationalAirTransportAssociation,800PlaceVictoria,
www.access.gpo.gov. PO Box 113, Montreal-H4Z 1M1, Quebec, Canada.
E2770 − 17
IATA DGR Addendum II March 2005 agent for public health action can only be performed by a LRN
IATA DGR Addendum III July 2005 national or reference laboratory.
2.6 ANSI Standards:
3.1.8 decontamination,n—thephysicalorchemicalprocess,
ANSI Z87.1-2003 American National Standard for Occupa-
or both, of reducing and preventing the spread of contaminants
tional and Educational Personal Eye and Face Protection
from people, animals, the environment, or equipment involved
Devices
at hazardous materials/weapons of mass destruction (WMD)
ANSI Z88.2-1992 American National Standard Practices
incidents. NFPA
for Respiratory Protection
3.1.9 emergency operations center (EOC), n—the physical
ANSI Z88.10-2001 American National Standard for Per-
locationatwhichthecoordinationofinformationandresources
sonal Protection - Respirator Fit Testing Methods
to support domestic incident management activities normally
ANSI/ISEA Z89.1-2003 American National Standard for
takes place. An EOC may be a temporary facility or may be
Personal Protection - Protective Headwear for Industrial
located in a more central or permanently established facility,
Workers Requirements
perhaps at a higher level of organization within a jurisdiction.
ANSI/Compressed GasAssociation, CGAG-7.1-1997 Com-
EOCs may be organized by major functional disciplines (for
modity Specification for Air
example, fire, law enforcement, and medical services), by
2.7 International Standards and Guidance:
jurisdiction (for example, Federal, State, regional, county, city,
IAFC International Association of Fire Chiefs (IAFC)
tribal), or some combination thereof. NIMS
Guidance,ModelProceduresforRespondingtoaPackage
with Suspicion of a Biological Threat, October 2008 3.1.10 emergency responder, n—includes state, local, and
ISO/IEC Standard 17043 Conformity assessment—General
tribal emergency public safety, law enforcement, emergency
requirements for proficiency testing response, emergency medical (including hospital emergency
facilities), and related personnel, agencies, and authorities. See
3. Terminology
Section 2 (6), Homeland Security Act of 2002, Pub. L.
3.1 Definitions: 107-296, 116 Stat. 2135 (2002). Also known as Emergency
Response Provider. NIMS
3.1.1 aseptic technique, n—operation or performance of a
procedure or method under carefully controlled conditions to
3.1.11 emergency response, n—the performance of actions
reduce the risk of exposure and prevent the introduction of
to mitigate the consequences of an emergency for human
unwanted material/matter (contamination) into a sample.
health and safety, quality of life, the environment and property.
3.1.2 authority having jurisdiction (AHJ), n—the
It may also provide a basis for the resumption of normal social
organization, office, or individual responsible for enforcing the
and economic activity.
requirements of a code or standard, or approving equipment,
3.1.12 evacuation, n—organized, phased, and supervised
materials, an installation, or a procedure. NFPA
withdrawal, dispersal, or removal of civilians from dangerous
3.1.3 biological agent, n—any microorganism (including
or potentially dangerous areas, and their reception and care in
but not limited to, bacteria, viruses, fungi, rickettsiae, or
safe areas. NIMS
protozoa), or infectious substance, or any naturally occurring,
3.1.13 field screening, n—field measurements utilized early
bioengineered or synthesized component of any such microor-
in the response to define and characterize the potential hazards
ganism or infectious substance, capable of causing: (1) death,
present, including corrosive, flammable, volatile, radioactive,
disease, or other biological malfunction in a human, an animal,
or oxidizer hazards, and to support tactical decision making to
a plant, or another living organism; (2) deterioration of food,
address operational safety measures.
water, equipment, supplies, or material of any kind; or (3)
3.1.13.1 Discussion—Field screening does not include mea-
deleterious alteration of the environment. 18 USC 178
surements of biological properties, which is termed on-site
3.1.4 bulk powder, n—a visible powder, at least approxi-
biological assessments (see 3.1.20).
mately 1 tsp or 5 mL in volume amassed or dispersed over a
3.1.14 hazard,n—somethingthatispotentiallydangerousor
limited area (optimally, area should be less than 20 by 20 cm
(approximately 8 by 8 in.)). harmful, often the root cause of an unwanted outcome; a
danger or peril. NIMS
3.1.5 chain of custody, n—set of procedures and documents
to account for the integrity of a sample by tracking its handling
3.1.15 HAZMAT responder, n—a trained and certified indi-
and storage from point of sample collection to final disposition
vidual who is a member of a hazardous material response team
of the sample.
or qualified to respond to incidents involving toxic industrial
chemicals,chemicalwarfareagentsandotherweaponsofmass
3.1.6 cold zone, n—the uncontaminated area where workers
destruction, or both.AHAZMAT response specialist will have
are unlikely to be exposed to hazardous substances or danger-
additional training that may include response to specific
ous conditions; also known as Clean Zone or Support Zone.
weapons of mass destruction.
CPL 02-02-071 Directive
3.1.7 confirmatory analysis, n—a test or a series of assays 3.1.16 hot zone, n—the area, located on the site where
that definitively identifies the presence of a suspected sub- contamination is either known or expected and where potential
stance or agent. for greatest exposure exists; also known as Exclusion Zone or
3.1.7.1 Discussion—Confirmatory analysis of a biological ExZ. CPL 02-02-071 Directive
E2770 − 17
3.1.17 incident commander (IC), n—the individual respon- 3.1.28 warm zone, n—the transition area between the Ex-
sible for all incident activities, including the development of clusion Zone (ExZ or hot zone) and the Support Zone (SZ or
strategies and tactics and the ordering and release of resources. cold zone) used to reduce and limit the amount of contamina-
The IC has overall authority and responsibility for conducting tion on people and equipment, and in the air, water, and soil
incident operations and is responsible for the management of that may be transferred into nonhazardous areas; the CRZ
all incident operations at the incident site. NIMS contains decontamination facilities, and functions as a buffer
zone surrounding the ExZ; also known as the contamination
3.1.18 jurisdiction, n—a range or sphere of authority. Public
reduction zone or CRZ. CPL 02-02-071 Directive
agencies have jurisdiction at an incident within their area of
responsibility. Jurisdictional authority at an incident can be 3.1.29 weapon of mass destruction (WMD), n—any weapon
political, geographic (for example, city, county, tribal, State, or or device that is intended, or has the capability, to cause death
Federal boundary lines) or functional (for example, law or serious bodily injury to a significant number of people
enforcement, public health). NIMS through the release, dissemination, or impact of (1) toxic or
poisonous chemicals or their precursors; (2) a disease organ-
3.1.19 multiagency coordination system (MACS), n—a sys-
ism; or (3) radiation or radioactivity. U.S. Code Title 50, Ch.
tem that provides the architecture to support coordination for
40, Sect. 2302 War and National Defense Definitions
incident prioritization, critical resource allocation, communi-
cations systems integration, and information coordination.
3.2 Acronyms:
MACS assist agencies and organizations responding to an
3.2.1 AHJ—Authority Having Jurisdiction
incident. The elements of a MACS include facilities,
3.2.2 ANSI—American National Standards Institute
equipment, personnel, procedures, and communications. Two
3.2.3 ASTM—American Society for Testing and Materials
of the most commonly used elements are Emergency Opera-
3.2.4 CDC—Centers for Disease Control and Prevention
tions Centers and MAC Groups. NIMS
3.2.5 CFR—Code of Federal Regulations
3.1.20 on-site biological assessment, n—measurements of
properties inherent to biological materials performed in the
3.2.6 CRZ—Contamination Reduction Zone
field using rapid, field based procedures and assays.
3.2.7 CST—Civil Support Team
3.1.21 personal protective equipment (PPE), n—the equip-
3.2.8 DHS—Department of Homeland Security
ment provided to shield or isolate a person from the chemical,
3.2.9 DOT—Department of Transportation
biological, physical, and thermal hazards that can be encoun-
3.2.10 EOC—Emergency Operations Center
tered at hazardous materials/weapons of mass destruction
(WMD) incidents. NFPA
3.2.11 EPA—Environmental Protection Agency
3.1.22 presumptive test, n—non-definitive test used to
3.2.12 ExZ—Exclusion Zone
evaluate a material for the presence of a substance or agent, or
3.2.13 FBI—Federal Bureau of Investigation
the presence of signatures of a substance or agent.
3.2.14 FEMA—Federal Emergency Management Agency
3.1.23 risk, n—the probability of suffering a loss or harm or
3.2.15 HAZMAT—Hazardous Materials
injury; peril.
3.2.16 HHS—Health and Human Services
3.1.24 secondary threats, n—any object designed, or per-
3.2.17 HSEEP—Homeland Security Exercise and Evalua-
son(s)withanintent,tocauseharmtopersonsrespondingtoan
incident (emergency responders) or to increase the number of tion Program
civilian casualties. Secondary threats are normally devised to
3.2.18 IAFC—International Association of Fire Chiefs
cause harm after persons have responded to an incident scene.
3.2.19 IATA—International Air Transport Association
3.1.25 termination, n—termination of the incident in the
3.2.20 IC—Incident Commander
context of this standard is the end of life safety operations,
3.2.21 ICS—Incident Command System
investigativework,andassuranceofprotectivemeasureimple-
mentation. This will include documentation of hazards present
3.2.22 IEC—International Electrotechnical Commission
and conditions found.
3.2.23 ISEA—International Safety Equipment Association
3.1.26 threat, n—an indication of possible violence, harm,
3.2.24 ISO—International Organization for Standardization
or danger and may include an indication of intent and
3.2.25 LRN—Laboratory Response Network
capability. NIMS
3.2.26 MACS—Multiagency Coordination System
3.1.27 toxin, n—the toxic material or product of plants,
3.2.27 NFPA—National Fire Protection Association
animals, microorganisms (including but not limited to,
bacteria, viruses, fungi, rickettsiae, or protozoa), or infectious
3.2.28 NIMS—National Incident Management System
substances, or a recombinant or synthesized molecule, what-
3.2.29 NIOSH—National Institute for Occupational Safety
ever their origin and method of production, and includes: (1)
and Health
any poisonous substance or biological product that may be
3.2.30 NRC—Nuclear Regulatory Commission
engineered as a result of biotechnology produced by a living
organism; or (2) any poisonous isomer or biological product, 3.2.31 OSHA—Occupational Safety and HealthAdministra-
homolog, or derivative of such a substance. 18 USC 178 tion
E2770 − 17
3.2.32 PPE—Personal Protective Equipment enforcement, Federal Bureau of Investigation, and public
health personnel as well as other responders that are respon-
3.2.33 SZ—Support Zone
sible for responding to a threat incident involving a biological
3.2.34 UC—Unified Command
agent or toxin, or both.
3.2.35 US&R—Urban Search and Rescue Teams
5.2 This guide supports, and should be utilized as an
3.2.36 WMD—Weapons of Mass Destruction
accompaniment to standard sample collection methods (for
example, Practices E2458). Standard guidance insures reduced
4. Summary of Guide
exposure risk, minimizes on-site sample consumption for
preservation of public health samples and forensic samples,
4.1 This guide provides the critical elements essential for
emergency response agency personnel to plan, develop, reduces variability associated with sample handling, and
analysis,andincreasesthereliabilityofthesamplingprocedure
coordinate, implement and train on standardized guidelines
that encompass policy, strategy, operations, and tactical deci- when collecting a sample of suspect biological agents and
toxins.
sions prior to responding to a threat event with a biological
agent or toxin, or both.
5.3 Development of this standard was at the request and
with considerable contributions from the public health and first
4.2 This document provides guidance for the responders to
responder communities in the United States to facilitate col-
an incident involving a potential biological threat. Emergency
responders(forexample,HAZMATresponseteams)workwith lection and evaluation of potential biological agents and toxins
in the field.
local and federal law enforcement and public health officials to
determine if there exists a credible threat incident involving a
5.4 This guide should be incorporated as a reference in
biological agent or toxin, or both. The determination of a
Emergency Operation Centers (EOCs), emergency operations
crediblebiologicalthreatismadethroughconsultationwiththe
plans (EOPs) and Multiagency Coordination Systems (MACS)
FBI. Responders should involve, inform, consult, and defer to
to assist in policy formation and development of strategic
the FBI in all cases where a credible biological threat is
objectives consistent with the needs of the Incident Com-
encountered.
mander (IC).
4.3 This guide provides recommendations for effective re-
5.5 Documents developed from this standard guide should
sponse planning and program development.
be referenced and revised as necessary and reviewed on a
4.4 This guide addresses collecting samples for public two-year cycle (at a minimum). The review shall consider new
and updated requirements and guidance, technologies, and
safety purposes.
other information or equipment that might have a significant
4.5 This guide addresses the fundamentals needed to sup-
impact on the management and outcome of biological inci-
port sampling and screening capability development by emer-
dents.
gencyresponderswithinajurisdictionorpracticeareatoassure
proper involvement and communication among responding
6. Planning for Response to Incidents Involving
organizations.
Biological Agents and Toxins
4.6 This guidance includes minimum training requirements,
6.1 Participants in the planning process should include, for
including requirements for individuals trained to work with
each jurisdiction assuming responsibility:
hazardous materials in the hot zone (Ref: NFPA472 or OSHA
6.1.1 Reference laboratory(s) within the LRN.
- 29 CFR 1910.120), requirements for training to perform
6.1.2 Public health, including:
initial explosive substance, chemical and radiological screen-
6.1.2.1 Public health officers and their designated Bioterror-
ing and for persons conducting the field screening and sample
ism Coordinators, if applicable.
collection in response to potential threats with biological
6.1.2.2 Environmental health.
agents or toxins, or both.
6.1.2.3 Occupational safety and health.
4.7 This guide provides references for determining the
6.1.2.4 Epidemiology.
appropriate level of personal protective equipment (PPE) to
6.1.2.5 Communicable disease.
mitigate hazards during sample collection and screening in an
6.1.2.6 Applicable members of the National Association of
incident with a potential biological agent or toxin, or both.
County and City Health Officials (NACCHO).
6.1.3 Executive policy makers for the jurisdiction.
5. Significance and Use
6.1.4 Law enforcement.
5.1 Community knowledge and experience related to emer- 6.1.4.1 Local.
6.1.4.2 County.
gencyresponsetothreatswithabiologicalagentortoxinatthe
Federal, State, tribal, and local levels has been translated into 6.1.4.3 State.
6.1.4.4 Tribal.
a standard guide to assist responder agencies’progress toward
the goal of building operational guidelines for the sample 6.1.4.5 Federal.
(1) Federal Bureau of Investigation.
collection and response to a potential biological agent or toxin.
The guide is intended to enhance the ability, knowledge, and (2) U.S. Postal Inspection Services.
6.1.5 Fire departments.
communication between emergency response team
representatives,includingfiredepartment,HAZMAT,locallaw 6.1.6 Special resources, including:
E2770 − 17
6.1.6.1 Hazardous materials (HAZMAT) response teams. 7. Training Program Development
6.1.6.2 Bomb squads.
7.1 Responders tasked with the initial response to an inci-
6.1.6.3 National Guard Weapons of Mass Destruction
dent involving a suspect biological agent or toxin, including
(WMD) Civil Support Teams (CSTs).
samplecollectionandfieldscreeningmustbetrainedaccording
6.1.6.4 Urban Search and Rescue Teams (US&R).
to recognized training standards.
6.1.7 Special target/high risk facilities or institutions.
7.2 A training program shall be developed through coordi-
6.1.8 Federal Emergency Management Agency (FEMA).
nation between the initial responder organization, which may
6.1.9 State, County, and Local Emergency Agencies. be the hazardous materials response unit, LRN reference
laboratory, local law enforcement, the FBI, and other agencies
6.2 Planning participants should meet to develop agree-
as defined by planning participants.
ments consistent with jurisdictional policies pertaining to all
7.3 Atraining program shall include a curriculum similar to
aspects of the response; specifically for this guide, planning
shall focus on coordination for initial response including but the training required to receive certification as a Hazardous
Materials Technician, meeting the standards of the National
not limited to:
Fire Protection Association standard, NFPA472, on responder
6.2.1 Roles and responsibilities.
competencies.
6.2.2 PPE and appropriate protective measures.
6.2.3 Notification and communications including risk com- 7.4 An alternative training level may be necessary for
certain jurisdictions that may include training personnel at the
munication.
level of Operations Level Responder under NFPA 472 with
6.2.4 Decision making process for sample collection, sub-
additional mission specific competencies. Hazardous Materials
mission to and acceptance by the receiving LRN reference
Technician Training meeting the NFPA 472 standard is highly
laboratory.
preferred; less training should only be employed for jurisdic-
6.2.4.1 For resource management purposes and to avoid the
tions and agencies where the responder does not have other
unnecessary testing of samples that potentially pose no public
HAZMAT responsibilities that require technician level train-
health threat, the LRN reference laboratory, in coordination
ing. Where lesser trained responders are utilized, operations
with the jurisdiction and the FBI, should develop a list of
should provide for consultation with a Hazardous Materials
acceptance criteria for sample submission which can be modi-
Technician. Responders should possess the knowledge, skills,
fied as needed.
and abilities as described in NFPA 472:
6.2.4.2 The jurisdiction may choose to prioritize (for
7.4.1 Chapter 5: Core Competencies for Operational Level
example, FBI-led threat credibility evaluation is required) or
Responders.
classify an incident to determine if a sample is collected. A
7.4.2 Chapter 6: Competencies for Operations Level Re-
jurisdiction or the receiving LRN reference laboratory may
sponders Assigned Mission-Specific Responsibilities.
require a sample to be prioritized to accept the sample. The
7.4.2.1 Section 6.1: General.
receiving LRN reference laboratory may also choose to priori-
7.4.2.2 Section 6.2: Mission Specific Competencies: Per-
tize samples in order to effectively execute sample analysis for
sonal Protective Equipment.
specific samples in the case that several samples are submitted
7.4.2.3 Section 6.4: Mission Specific Competencies: Tech-
at the same time.
nical Decontamination.
6.2.4.3 The jurisdiction may develop guidance including a
7.4.2.4 Section 6.7: Mission Specific Competencies: Air
flow chart that specifies procedures for both threat and hazard
Monitoring and Sampling.
assessment of an event and help to define when to collect and
7.4.2.5 Annex B: Competencies for Operations Level Re-
send a sample to a LRN reference laboratory based on level of
sponders Assigned Biological Agent–Specific Tasks.
risk determined during field assessment.
6.2.5 Training.
7.5 Additional training courses, professional conferences,
and standards may include:
6.2.6 Sample collection methods and materials including
sampling kits. 7.5.1 DHS Office of Domestic Preparedness Course – “Pub-
lic Safety Response – Sampling Techniques and Guidelines”
6.2.7 Screening/detection technologies and analysis.
(PER – 222).
NOTE 1—Field screening methods may have limits of detection inad-
7.5.2 DHS Office of Domestic Preparedness Course - “Ad-
equate for material identification.
vanced Chemical and Biological Integrated Response – Tech-
6.2.8 Packaging.
nician Level” (PER – 226).
6.2.9 Decontamination procedure. 7.5.3 Implementation of Practices E2458.
7.5.4 National conferences on environmental sampling and
6.2.10 Transportation.
detection for biological agents and toxins.
6.2.11 Documentation, including:
7.5.5 Biosafety in Microbiology and Biomedical Laborato-
6.2.11.1 Standardized or uniform sample submission and
ries (BMBL).
chain-of-custody forms.
6.2.11.2 Contact information for responder, public health 7.6 Training program components shall include but may not
be limited to:
and law enforcement on-scene and on-call coordination repre-
sentatives. 7.6.1 Understanding biological agents.
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: E2770 − 10 E2770 − 17
Standard Guide for
Operational Guidelines for Initial Response to a Suspected
Biothreat AgentSuspected Biological Agents and Toxins
This standard is issued under the fixed designation E2770; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
A biothreat threat with a biological agent or toxin is a serious matter that affects public health, public
safety, the economy and the general confidence of the people. The National Strategy for Homeland
Security and its National Response Framework focuses homeland security efforts on preventing and
disrupting terrorist attacks, protecting the American people, our critical infrastructure and key
resources, and responding to and recovering from incidents that do occur while continuing to
strengthen the foundation of our nation. As laid out by the National Response Framework, a
coordinated and synchronous response to suspected acts of bio-terrorism requires advance planning,
including the equipping and training of emergency responders prior to an incident. The goal of this
standard guide is to support national standards for responding to and collecting suspected biothreat-
biological agents and toxins with guidance centered on coordination among representatives of
emergency response teams, including hazardous materials response teams, law enforcement, public
health, including the Centers for Disease Control and Prevention (CDC) national Laboratory Response
Network (LRN), and the Federal Bureau of Investigation (FBI). This standard guide provides uniform
guidance that covers all of the following components: response planning, responder training,
competency evaluation, proficiency testing, concept of operations, hazard assessment, threat
evaluation, sample collection, field screening, risk communication and documentation for responding
to visible powders suspected of being biothreat agents. an incident suspected of a biological agent or
toxin, or both.
1. Scope
1.1 This guide provides considerations for decision-makers when responding to incidents that may involve biothreats. biological
agents and toxins. This guide provides information and guidance for inclusion in response planning, on activities to conduct during
an initial response to an incident involving suspected biothreat agents. biological agents or toxins, or both.
1.2 This guide delineates fundamental requirements for developing a biothreat sampling and screening capability for biological
agents or toxins, or both, within a jurisdiction, practice, or operational area to assure proper involvement, communication, and
coordination of all relevant agencies.
1.3 This guide applies to emergency response agencies that have a role in the initial response to a biothreat incident. unknown
threats that are suspected biological agents and toxins. This guide is designed for but not limited to emergency response services
such as law enforcement, fire departments, hazardous materials, public health, and emergency management.
1.4 This guide assumes implementation begins well before the recognition of a suspected biothreat event an event with a
suspected biological agent or toxin, or both, and ends when emergency response actions cease or the response is assumed by federal
response teams.
1.5 This guide utilizes risk-based response architecture and the guidance as described in the National Response Framework and
is intended to be coupled with the authority having jurisdiction’s (AHJs) understanding of local vulnerabilities and capabilities
when developing its plans and guidance documents on response to incidents involving a suspected biothreat.biological agent or
toxin, or both.
This practiceguide is under the jurisdiction of ASTM Committee E54 on Homeland Security Applications and is the direct responsibility of Subcommittee E54.01 on
CBRNE Sensors and Detectors.
Current edition approved Oct. 15, 2010April 1, 2017. Published November 2010May 2017. Originally approved in 2010. Last previous edition approved in 2010 as
E2770 – 10. DOI: 10.1520/E2770-10.10.1520/E2770-17.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E2770 − 17
1.6 This guide is compliant with the National Incident Management System (NIMS) and uses Incident Command System (ICS)
common terminology. Full compliance with NIMS is recognized as an essential part of emergency response planning. In
developing this standard, every effort was made to ensure that all communications between organizational elements during an
incident are presented in plain language according to NIMS 2008. In keeping with this NIMS requirement, key definitions and
terms, using plain English, are incorporated.
1.7 This guide does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of
the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory
limitations prior to use.
1.8 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2.1 ASTM Standards:
E2458 Practices for Bulk Sample Collection and Swab Sample Collection of Visible Powders Suspected of Being Biothreat
Agents from Nonporous Surfaces
E2601 Practice for Radiological Emergency Response
F2412 Test Methods for Foot Protection
F2413 Specification for Performance Requirements for Protective (Safety) Toe Cap Footwear
2.2 Federal Government Regulations:
18 USC 175178 Prohibitions with respect to biological weaponsDefinitions
18 USC 1038 False Information and Hoaxes
DOT - 49 CFR, Parts 171-180 Hazardous Materials Regulations
DOT - 49 CFR 172, Subpart H Transportation Training
DOT - 49 CFR 173 General Requirements for Shipments and Packaging
DOT - 49 CFR 178 Specifications for Packaging
EPA - 40 CFR 300 National Oil and Hazardous Substances Pollution Contingency Plan (NCP)
EPA - 40 CFR 311 Worker Protection
NRC - 10 CFR 20 Standards for Protection against Radiation
NIOSH - 42 CFR 84 Respiratory Protective Devices
OSHA - 29 CFR 1910 Subpart Z and 29 CFR 1926 Subpart Z Toxic and Hazardous Substances
OSHA - 29 1910.1096 and 29 CFR 1926.53 Ionizing Radiation
OSHA - 29 CFR 1910.120 Hazardous Waste Operations and Emergency Response (HAZWOPER) standard
OSHA - 29 CFR 1910 Subpart I (Sections 132 to 139) Personal Protective Equipment
OSHA - 29 CFR 1910.1200 Hazard Communication
2.3 Federal Guidance:
FBI-DHS-HHS/CDC Coordinated Document, Guidance on Initial Response to a Suspicious Letter/Container with a Potential
Biological threat, November 2, 2004.
NIMS 2008 National Incident Management System
Planning Guidance for Recovery Following Biological Incidents, Biological Decontamination Standards Working Group,
Subcommittee on Decontamination Standards and Technology Committee on Homeland and National Security, National
Science and Technology Council, May 2009
NRF 2008 National Response Framework
OSHA - CPL 02-02-073 Inspection Procedures for 29 CFR 1910.120 and 1926.65, Paragraph (q): Emergency Response to
Hazardous Substance Releases
EPA - Safety, Health, and Environmental Management (SHEM) Guide No. 44 Personal Protective Equipment, October 2004
EPA - Safety, Health, and Environmental Management (SHEM) Guideline No. 46 Respiratory Protection, dated October 2004
EPA - Order 1460.1 Occupational Medical Surveillance Program, June 18, 1996
EPA/600/R-08/105 EPA All Hazards Receipt Facility Screening Protocol EPA All Hazards Receipt Facility Screening Protocol,
(EPA/600/R-08/105) September 2008
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Available from U.S. Government Printing Office Superintendent of Documents, 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
www.access.gpo.gov.
Available from Federal Emergency Management Agency (FEMA), 500 C St., SW, Washington, DC 20472, http://www.fema.gov.
Available from http://HAZMAT.dot.gov/pubs/erg/gydebook.htm.Environmental Protection Agency (EPA), 1200 Pennsylvania Ave, NW, Washington, DC 20460,
http://nepis.epa.gov.
E2770 − 17
NIOSH Publication No. 2009-132 Recommendations for the Selection and Use of Respirators and Protective Clothing for
Protection Against Biological Agents
FBI Laboratory Publication: Handbook of Forensic Services 20032013
DOT, current version, Emergency Response Guidebook (ERG)
CDC/NIOSH Surface Sampling Procedures for Bacillus anthracis Spores from Smooth, Non-porous Surfaces, April 26, 2012
DHS – Framework for a Biothreat Field Response Mission Capability, April 2011
2.4 NFPA Standards:
NFPA 472 Standard for Competence of Responders to Hazardous Materials/Weapons of Mass Destruction Incidents, 2008
Edition
NFPA 1994 Standard on Protective Ensembles for Chemical/Biological Terrorism Incidents
NFPA 1600 Standard on Disaster/Emergency Management and Business Continuity Programs, 2007Continuity/Continuity of
Operations Programs, 2016 Edition
2.5 IATA Standards:
IATA PI 602 Infectious Diseases (Infectious Substances)
IATA PI 650 Shipping of Diagnostic Samples
IATA DGR 46th Edition 2005
IATA DGR Addendum I January 2005
IATA DGR Addendum II March 2005
IATA DGR Addendum III July 2005
2.6 ANSI Standards:
ANSI Z41-1999 American National Standard for Personal Protection - Protective Footwear
ANSI Z87.1-2003 American National Standard for Occupational and Educational Personal Eye and Face Protection Devices
ANSI Z88.2-1992 American National Standard Practices for Respiratory Protection
ANSI Z88.10-2001 American National Standard for Personal Protection - Respirator Fit Testing Methods
ANSI/ISEA Z89.1-2003 American National Standard for Personal Protection - Protective Headwear for Industrial Workers
Requirements
ANSI/Compressed Gas Association, CGA G-7.1-1997 Commodity Specification for Air
2.7 International Standards and Guidance:
IAFC International Association of Fire Chiefs (IAFC) Guidance, Model Procedures for Responding to a Package with Suspicion
of a Biological Threat, October 2008
ISO/IEC Guide 43Standard 17043 ISO/IEC Standard 17043 Conformity assessment—General requirements for proficiency
testing
3. Terminology
3.1 Definitions:
3.1.1 aseptic technique, n—operation or performance of a procedure or method under carefully controlled conditions to reduce
the risk of exposure and prevent the introduction of unwanted material/matter (contamination) into a sample.
3.1.2 authority having jurisdiction (AHJ), n—the organization, office, or individual responsible for enforcing the requirements
of a code or standard, or approving equipment, materials, an installation, or a procedure. NFPA
3.1.3 biothreatbiological agent, n—any microorganism, virus, infectious substance, or biological product that may be
engineered as a result of biotechnology, or any naturally occurring or bioengineeredmicroorganism (including but not limited to,
bacteria, viruses, fungi, rickettsiae, or protozoa), or infectious substance, or any naturally occurring, bioengineered or synthesized
component of any such microorganism, virus,microorganism or infectious substance, or biological product, capable of causing: (1)
death, disease, or other biological malfunction in a human, an animal, a plant, or another living organism; (2) deterioration of food,
water, equipment, supplies, or material of any kind; or (3) or, deleterious alteration of the environment. 18 USC 175178
3.1.4 bulk powder, n—a visible powder, at least approximately 1 tsp or 5 mlmL in volume amassed or dispersed over a limited
area (optimally, area should be less than 20 by 20 cm (approximately 8 by 8 in.)).
3.1.5 chain of custody, n—set of procedures and documents to account for the integrity of a sample by tracking its handling and
storage from point of sample collection to final disposition of the sample.
3.1.6 cold zone, n—the uncontaminated area where workers are unlikely to be exposed to hazardous substances or dangerous
conditions; also known as Clean Zone or Support Zone. CPL 02-02-071 Directive
Available from http://HAZMAT.dot.gov/pubs/erg/gydebook.htm.
Available from http://www.cdc.gov/niosh/topics/emres/surface-sampling-bacillus-anthracis.html.
Available from http://www.hsdl.org/?view&did=767721.
Available from National Fire Protection Association (NFPA), 1 Batterymarch Park, Quincy, MA 02169-7471, http://www.nfpa.org.
Available from the International Air Transport Association, 800 Place Victoria, PO Box 113, Montreal-H4Z 1M1, Quebec, Canada.
E2770 − 17
3.1.7 confirmatory analysis, n—a test or a series of assays that definitively identifies the presence of a suspected substance or
agent.
3.1.7.1 Discussion—
Confirmatory analysis of a biothreat biological agent for public health action can only be performed by a LRN national or reference
laboratory.
3.1.8 decontamination, n—the physical or chemical process, or both, of reducing and preventing the spread of contaminants
from people, animals, the environment, or equipment involved at hazardous materials/weapons of mass destruction (WMD)
incidents. NFPA
3.1.9 emergency operations center (EOC), n—the physical location at which the coordination of information and resources to
support domestic incident management activities normally takes place. An EOC may be a temporary facility or may be located in
a more central or permanently established facility, perhaps at a higher level of organization within a jurisdiction. EOCs may be
organized by major functional disciplines (for example, fire, law enforcement, and medical services), by jurisdiction (for example,
Federal, State, regional, county, city, tribal), or some combination thereof. NIMS
3.1.10 emergency responder, n—includes state, local, and tribal emergency public safety, law enforcement, emergency response,
emergency medical (including hospital emergency facilities), and related personnel, agencies, and authorities. See Section 2 (6),
Homeland Security Act of 2002, Pub. L. 107-296, 116 Stat. 2135 (2002). Also known as Emergency Response Provider. NIMS
3.1.11 emergency response, n—the performance of actions to mitigate the consequences of an emergency for human health and
safety, quality of life, the environment and property. It may also provide a basis for the resumption of normal social and economic
activity.
3.1.12 evacuation, n—organized, phased, and supervised withdrawal, dispersal, or removal of civilians from dangerous or
potentially dangerous areas, and their reception and care in safe areas. NIMS
3.1.13 field screening, n—field measurements utilized early in the site assessment process response to define and delineat-
echaracterize the contaminants present, support tactical decision making and address operational safety measures. Field screening
does not include measurements of biological properties which is termed on-site biological assessments (see potential hazards
present, including corrosive, flammable, volatile, radioactive, or oxidizer hazards, and to support tactical decision making to
address operational safety measures. 3.1.20).
3.1.13.1 Discussion—
Field screening does not include measurements of biological properties, which is termed on-site biological assessments (see
3.1.20).
3.1.14 hazard, n—something that is potentially dangerous or harmful, often the root cause of an unwanted outcome; a danger
or peril. NIMS
3.1.15 HAZMAT responder, n—a trained and certified individual who is a member of a hazardous material response team or
qualified to respond to incidents involving toxic industrial chemicals, chemical warfare agents and other weapons of mass
destruction, or both. A HAZMAT response specialist will have additional training to respond to that may include response to
specific weapons of mass destruction.
3.1.16 hot zone, n—the area, located on the site where contamination is either known or expected and where potential for
greatest exposure exists; also known as Exclusion Zone or ExZ. CPL 02-02-071 Directive
3.1.17 incident commander (IC), n—the individual responsible for all incident activities, including the development of strategies
and tactics and the ordering and release of resources. The IC has overall authority and responsibility for conducting incident
operations and is responsible for the management of all incident operations at the incident site. NIMS
3.1.18 jurisdiction, n—a range or sphere of authority. Public agencies have jurisdiction at an incident within their area of
responsibility. Jurisdictional authority at an incident can be political, geographic (for example, city, county, tribal, State, or Federal
boundary lines) or functional (for example, law enforcement, public health). NIMS
3.1.19 multiagency coordination system (MACS), n—a system that provides the architecture to support coordination for incident
prioritization, critical resource allocation, communications systems integration, and information coordination. MACS assist
agencies and organizations responding to an incident. The elements of a MACS include facilities, equipment, personnel,
procedures, and communications. Two of the most commonly used elements are Emergency Operations Centers and MAC Groups.
NIMS
3.1.20 on-site biological assessment, n—measurements of properties inherent to biological materials performed in the field
using rapid, field based procedures and assays.
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3.1.21 personal protective equipment (PPE), n—the equipment provided to shield or isolate a person from the chemical,
biological, physical, and thermal hazards that can be encountered at hazardous materials/weapons of mass destruction (WMD)
incidents. NFPA
3.1.22 presumptive test, n—non-definitive test used to evaluate a material for the presence of a substance or agent, or the
presence of signatures of a substance or agent.
3.1.23 risk, n—the probability of suffering a loss or harm or injury; peril.
3.1.24 secondary threats, n—any object designed, or person(s) with an intent, to cause harm to persons responding to an incident
(emergency responders) or to increase the number of civilian casualties. Secondary threats are normally devised to cause harm after
persons have responded to an incident scene.
3.1.25 termination, n—termination of the incident in the context of this standard is the end of life safety operations, investigative
work, and assurance of protective measure implementation. This will include documentation of hazards present and conditions
found.
3.1.26 threat, n—an indication of possible violence, harm, or danger and may include an indication of intent and capability.
NIMS
3.1.27 toxin, n—the toxic material or product of plants, animals, microorganisms (including but not limited to, bacteria, viruses,
fungi, rickettsiae, or protozoa), or infectious substances, or a recombinant or synthesized molecule, whatever their origin and
method of production, and includes: (1) any poisonous substance or biological product that may be engineered as a result of
biotechnology produced by a living organism; or (2) any poisonous isomer or biological product, homolog, or derivative of such
a substance. 18 USC 178
3.1.28 warm zone, n—the transition area between the Exclusion Zone (ExZ or hot zone) and the Support Zone (SZ or cold zone)
used to reduce and limit the amount of contamination on people and equipment, and in the air, water, and soil that may be
transferred into nonhazardous areas; the CRZ contains decontamination facilities, and functions as a buffer zone surrounding the
ExZ; also known as the contamination reduction zone or CRZ. CPL 02-02-071 Directive
3.1.29 weapon of mass destruction (WMD), n—any weapon or device that is intended, or has the capability, to cause death or
serious bodily injury to a significant number of people through the release, dissemination, or impact of (1) toxic or poisonous
chemicals or their precursors; (2) a disease organism; or (3) radiation or radioactivity. U.S. Code Title 50, Ch. 40, Sect. 2302 War
and National Defense Definitions
3.2 Acronyms:
3.2.1 AHJ—Authority Having Jurisdiction
3.2.2 ANSI—American National Standards Institute
3.2.3 ASTM—American Society for Testing and Materials
3.2.4 CDC—Centers for Disease Control and Prevention
3.2.5 CFR—Code of Federal Regulations
3.2.6 CRZ—Contamination Reduction Zone
3.2.7 CST—Civil Support Team
3.2.8 DHS—Department of Homeland Security
3.2.9 DOT—Department of Transportation
3.2.10 EOC—Emergency Operations Center
3.2.11 EPA—Environmental Protection Agency
3.2.12 ExZ—Exclusion Zone
3.2.13 FBI—Federal Bureau of Investigation
3.2.14 FEMA—Federal Emergency Management Agency
3.2.15 HAZMAT—Hazardous Materials
3.2.16 HHS—Health and Human Services
3.2.17 HSEEP—Homeland Security Exercise and Evaluation Program
3.2.18 IAFC—International Association of Fire Chiefs
3.2.19 IATA—International Air Transport Association
3.2.20 IC—Incident Commander
3.2.21 ICS—Incident Command System
3.2.22 IEC—International Electrotechnical Commission
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3.2.23 ISEA—International Safety Equipment Association
3.2.24 ISO—International Organization for Standardization
3.2.25 LRN—Laboratory Response Network
3.2.26 MACS—Multiagency Coordination System
3.2.27 NFPA—National Fire Protection Association
3.2.28 NIMS—National Incident Management System
3.2.29 NIOSH—National Institute for Occupational Safety and Health
3.2.30 NRC—Nuclear Regulatory Commission
3.2.31 OSHA—Occupational Safety and Health Administration
3.2.32 PPE —PPE—Personal Protective Equipment
3.2.33 SZ—Support Zone
3.2.34 UC—Unified Command
3.2.35 USAR—US&R—Urban Search and Rescue Teams
3.2.36 WMD—Weapons of Mass Destruction
4. Summary of Guide
4.1 This guide provides the critical elements essential for emergency response agency personnel to plan, develop, coordinate,
implement and train on standardized guidelines that encompass policy, strategy, operations, and tactical decisions prior to
responding to a biothreat event.threat event with a biological agent or toxin, or both.
4.2 This document provides guidance for the responders to an incident involving a potential biological threat. Emergency
responders (for example, HAZMAT response teams) work with local and federal law enforcement and public health officials to
determine if there exists a credible biothreat incident exists. threat incident involving a biological agent or toxin, or both. The
determination of a credible biological threat is made through consultation with the FBI. Responders should involve, inform,
consult, and defer to the FBI in all cases where a credible biological threat is encountered.
4.3 This guide provides recommendations for effective response planning and program development.
4.4 This guide addresses collecting samples for public safety purposes.
4.5 This guide addresses the fundamentals needed to support sampling and screening capability development by emergency
responders within a jurisdiction or practice area to assure proper involvement and communication among responding organizations.
4.6 This guidance includes minimum training requirements, including requirements for individuals trained to work with
hazardous materials in the hot zone (Ref: NFPA 472 or OSHA - 29 CFR 1910.120), requirements for training to perform initial
explosive substance, chemical and radiological screening and for persons conducting the field screening and sample collection in
response to potential biothreats.threats with biological agents or toxins, or both.
4.7 This guide provides references for determining the appropriate level of personal protective equipment (PPE) to mitigate
hazards during sample collection and screening in an incident with a potential biothreat agent.biological agent or toxin, or both.
5. Significance and Use
5.1 Community knowledge and experience related to emergency response to biothreats threats with a biological agent or toxin
at the Federal, State, tribal, and local levels has been translated into a standard guide to assist responder agencies’ progress toward
the goal of building operational guidelines for the sample collection and response to a potential biothreat agent. biological agent
or toxin. The guide is intended to enhance the ability, knowledge, and communication between emergency response team
representatives, including fire department, HAZMAT, local law enforcement, Federal Bureau of Investigation, and public health
personnel as well as other responders that are responsible for responding to a biothreat incident.threat incident involving a
biological agent or toxin, or both.
5.2 This guide supports, and should be utilized as an accompaniment to Practicesstandard E2458. Utilization of a standard
samplesample collection methods (for example, Practices E2458collection method and standard ). Standard guidance insures
reduced exposure risk, minimizes on-site sample consumption for preservation of public health samples and forensic samples,
reduces variability associated with sample handling, and analysis, and increases the reliability of the sampling procedure when
collecting a sample of suspect biothreat materials. biological agents and toxins.
5.3 Development of this standard was at the request and with considerable contributions from the public health and first
responder communities in the United States to facilitate collection and evaluation of potential biothreatbiological agents and toxins
in the field.
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5.4 This guide should be incorporated as a reference in Emergency Operation Centers (EOCs), emergency operations plans
(EOPs) and Multiagency Coordination Systems (MACS) to assist in policy formation and development of strategic objectives
consistent with the needs of the Incident Commander (IC).
5.5 Documents developed from this standard guide should be referenced and revised as necessary and reviewed on a two-year
cycle (at a minimum). The review shall consider new and updated requirements and guidance, technologies, and other information
or equipment that might have a significant impact on the management and outcome of biological incidents.
6. Planning for Response to Incidents Involving BiothreatsBiological Agents and Toxins
6.1 Participants in the planning process should include, for each jurisdiction assuming responsibility:
6.1.1 Reference laboratory(s) within the LRN.
6.1.2 Public health, including:
6.1.2.1 Public health officers and their designated Bioterrorism Coordinators, if applicable.
6.1.2.2 Environmental health.
6.1.2.3 Occupational safety and health.
6.1.2.4 Epidemiology.
6.1.2.5 Communicable disease.
6.1.2.6 Applicable members of the National Association of County and City Health Officials (NACCHO).
6.1.3 Executive policy makers for the jurisdiction.
6.1.4 Law enforcement.
6.1.4.1 Local.
6.1.4.2 County.
6.1.4.3 State.
6.1.4.4 Tribal.
6.1.4.5 Federal.
(1) Federal Bureau of Investigation.
(2) U.S. Postal Inspection Services.
6.1.5 Fire departments.
6.1.6 Special resources, including:
6.1.6.1 Hazardous materials (HAZMAT) response teams.
6.1.6.2 Bomb squads.
6.1.6.3 National Guard Weapons of Mass Destruction (WMD) Civil Support Teams (CSTs).
6.1.6.4 Urban Search and Rescue Teams (USAR).(US&R).
6.1.7 Special target/high risk facilities or institutions.
6.1.8 Federal Emergency Management Agency (FEMA).
6.1.9 State, County, and Local Emergency Agencies.
6.2 Planning participants should meet to develop agreements consistent with jurisdictional policies pertaining to all aspects of
the response; specifically for this guide, planning shall focus on coordination for initial response including but not limited to:
6.2.1 Roles and responsibilities.
6.2.2 PPE and appropriate protective measures.
6.2.3 Notification and communications including risk communication.
6.2.4 Decision making process for sample collection, submission to and acceptance by the receiving LRN reference laboratory.
6.2.4.1 For resource management purposes and to avoid the unnecessary testing of samples that potentially pose no public health
threat, the LRN reference laboratory, in coordination with the jurisdiction and the FBI, should develop a list of acceptance criteria
for sample submission which can be modified as needed.
6.2.4.2 The jurisdiction may choose to prioritize (for example, FBI credible threat assessment FBI-led threat credibility
evaluation is required) or classify an incident to determine if a sample is collected. A jurisdiction or the receiving LRN reference
laboratory may require a sample to be prioritized to accept the sample. The receiving LRN reference laboratory may also choose
to prioritize samples in order to effectively execute sample analysis for specific samples in the case that several samples are
submitted at the same time.
6.2.4.3 The jurisdiction may develop guidance including a flow chart that specifies procedures for both threat and hazard
assessment of an event and help to define when to collect and send a sample to a LRN reference laboratory based on level of risk
determined during field assessment.
6.2.5 Training.
6.2.6 Sample collection methods and materials including sampling kits.
6.2.7 Screening/detection technologies and analysis.
NOTE 1—Field screening methods may have limits of detection inadequate for material identification.
6.2.8 Packaging.
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6.2.9 Decontamination procedure.
6.2.10 Transportation.
6.2.11 Documentation, including:
6.2.11.1 Standardized or uniform sample submission and chain-of-custody forms.
6.2.11.2 Contact information for responder, public health and law enforcement on-scene and on-call coordination representa-
tives.
7. Training Program Development
7.1 Responders tasked with the initial response to a biothreat incident an incident involving a suspect biological agent or toxin,
including sample collection and field screening must be trained according to recognized training standards.
7.2 A training program shall be developed through coordination between the initial responder organization, which may be the
hazardous materials response unit, LRN reference laboratory, local law enforcement, the FBI, and other agencies as defined by
planning participants.
7.3 A training program shall include a curriculum similar to the training required to receive certification as a Hazardous
Materials Technician, meeting the standards of the National Fire Protection Association standard, NFPA 472, on responder
competencies.
7.4 An alternative training level may be necessary for certain jurisdictions that may include training personnel at the level of
Operations Level Responder under NFPA 472 with additional mission specific competencies. Hazardous Materials Technician
Training meeting the NFPA 472 standard is highly preferred; less training should only be employed for jurisdictions and agencies
where the responder does not have other HAZMAT responsibilities that require technician level training. Where lesser trained
responders are utilized, operations should provide for consultation with a Hazardous Materials Technician. Specific program
components and necessary competencies shall be determined with reference to the following specific sections of Responders
should possess the knowledge, skills, and abilities as described in NFPA 472:
7.4.1 Chapter 5: Core Competencies for Operational Level Responders.
7.4.2 Chapter 6: Competencies for Operations Level Responders Assigned Mission-Specific Responsibilities.
7.4.2.1 Section 6.1: General.
7.4.2.2 Section 6.2: Mission Specific Competencies: Personal Protective Equipment.
7.4.2.3 Section 6.4: Mission Specific Competencies: Technical Decontamination.
7.4.2.4 Section 6.7: Mission Specific Competencies: Air Monitoring and Sampling.
7.4.2.5 Annex B: Competencies for Operations Level Responders Assigned Biological Agent–Specific Tasks.
7.5 Additional training courses, professional conferences, and standards may include:
7.5.1 DHS Office of Domestic Preparedness Course – “Public Safety Response – Sampling Techniques and Guidelines” (PER
– 222).
7.5.2 DHS Office of Domestic Preparedness Course - “Advanced Chemical and Biological Integrated Response – Technician
Level” (PER – 226).
7.5.3 Implementation of Practices E2458.
7.5.4 National conferences on environmental sampling
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