GSA Policy Advisory:

National Guidelines for Assessing and Managing Biological Threats in
Federal Mail Facilities

December 29, 2003

# I. Introduction

In October 2001, terrorists contaminated the U.S. mail stream with
anthrax, resulting in illness and death of federal employees and the
public. The threat of similar attacks continues, and the authorities
have been called in to assess numerous hoaxes and suspect materials. To
protect the health and safety of federal employees and the public, and
to help deal with hoaxes and suspicious materials, federal agencies need
clear procedures for assessing and managing biological threats that
might be delivered in the mail.

GSA has developed this new set of guidelines as standard operating
procedures for dealing with any type of biological threat, in federal
mail centers nationwide. These guidelines have been developed in
coordination with a distinguished group of federal and non-federal
scientists and other experts (the individuals and organizations
participating in the group are listed in Appendix A). They replace the
previous " Guidelines for Federal Mail Centers in the Washington, DC
Metropolitan area for Managing Possible Anthrax Contamination" published
July 22, 2002 and "National Guidelines for Assessing and Managing
Biological Threats in Federal Mail Facilities" published in July, 2003.
As before, GSA is issuing these guidelines as part of its
responsibilities to the federal mail management community under the
Federal Records Act (44 U.S.C 2904).

The guidelines are arranged in five areas:

-   The all -- hazards approach

-   Preparing for biological threats

-   Identifying and assessing biological threats

-   Managing biological threats that appear credible

-   Sampling, testing, and sanitization.

GSA intends these guidelines for use by:

-   Mail center workers in federal facilities nationwide;

-   Managers of those facilities;

-   Environmental health and safety officers responsible for mail center
    workers; and

-   Federal executives responsible for mail operations.

In the integrated threat assessment and response to any threat, the
federal officials listed above must engage with a set of federal and
non-federal partners, including:

-   Local first responders to federal mail centers (fire, hazmat, and
    law enforcement);

-   Local public health authorities (disease control and laboratory);

-   Regional Federal Bureau of Investigation (FBI) Weapons of Mass
    Destruction (WMD) coordinators;

-   Local US Postal Inspectors.

[Definition of a "first responder"]{.underline}: A "first responder" is
an organization in your immediate area that provides trained people to
respond to emergency situations. You may need to establish relationships
with several different first responder organizations, depending on the
personnel and capability that they can provide. First responders to
federal mail facilities may be federal, state, and/or local
organizations, depending on your specific circumstances.

[Definition of a "federal mail center":]{.underline} A federal mail
center is a defined space where the mail for a federal agency is
processed.

**II. The All-Hazards Approach**

Many different threats can be sent through the mail. The initial triage,
or sorting and allocation of treatment to individuals according to a
system of priorities for any threat situation, must consider *all*
hazards. A critical element is assessing for the presence of:

-   Radiological threats;

-   Explosive devices;

-   Dangerous chemicals; and

-   

-   

-   B iological threats.

Effective, well-tested procedures exist for detection and response to
explosive devices, chemicals, and radiological materials. This document
is specifically designed to deal with suspected biological threats. This
section highlights one important difference in approach between
biological threats and other threats. Chemical and radiological agents
are rapidly known and require immediate consequence management.
Biological agents, on the other hand, are not as immediately
recognizable and consequence management may be delayed, for example by
therapy or vaccination, not traditionally performed by first responders.
However, effective countermeasures are available against many of the
bacteria, viruses, and toxins that might be used. If we develop a solid
understanding of the biological threats we face and how to respond to
them, many effects may be prevented or minimized. An on-line course on
"Biological Agents in the Mail Center" is also available at
www.gsa.gov/mailpolicy.

In response to a suspected known or suspected release of a chemical or
radiological agent, authorities may recommend that you "shelter in
place." This means that, rather than leave the place of work, employees
should stay in their office buildings and wait for instructions.

In a chemical attack, a toxic gas or liquid is used to contaminate
people or the environment. The prevalent symptoms are tightness in the
chest, difficulty breathing, blurred vision, stinging of the eyes, or
loss of coordination. If you witness a suspected chemical attack
outdoors, move upwind and away from the area as quickly as possible. If
this is not possible, move to a safe location inside a building and
shelter in-place. If you suffer any of the symptoms mentioned above, try
to remove any clothing you can and wash your body with soap and water.
Do not scrub the area, as this may wash the chemical into the skin. Seek
medical advice as soon as possible.

Dirty bombs are regular explosives that have been combined with either
radiation-causing material or chemical weapons. While most news reports
talk about radiological dirty bombs, chemical agents may be used as
well. A blast from this type of weapon normally looks like a regular
explosion, and the contamination spread is not often immediately
noticeable. When it is safe to do so, seek shelter inside a building or
basement, putting as much shelter between you and the potential
contaminant as possible. Limit the amount of exposure by leaving the
area when it is safe to do so.

Additional information on dealing with the other types of threats may be
obtained from sources listed in Appendix D. This document may be used to
help develop a better understanding of the biological threats we face
and the steps to take if a biological agent is suspected of being sent
through the mail. As the anthrax bio-terrorism events in 2001
illustrated, mail supervisors sometimes need to make judgments about
mail that relate to their security in receiving it. This document is
intended to provide a more effective process for federal employees to
screen their mail.

## 

## III. Preparing for biological threats

A biological threat is any biological material capable of causing:

-   Death, disease, or other biological malfunction in a human, an
    animal, a plant, or another living organism;

-   Deterioration of food, water, equipment, supplies or material of any
    kind;

-   Harmful alteration of the environment.

Advance preparation is critical to assessing and managing any biological
threat that may come in the mail. This section offers short discussions
of the key preparation steps. Every mail center should have a written
security plan. The plan should include the topics listed below. The U.
S. Postal Inspection Service (www.usps.com/postalinspectors) and the GSA
mail policy website (www.gsa.gov/mailpolicy) both provide much more
detailed guidance on all of the following topics:

[Security assessment]{.underline}: Start with a site-specific security
assessment, conducted by a qualified expert. Recognize that each site
has different threats and risk levels, and that this will lead to
different security measures for each site. The *GSA Mail Center
Manager's Security Guide* (www.gsa.gov/mailpolicy) includes a list of
resources for security assessments.

[Relationships with partner organizations:]{.underline}

-   Establish and maintain relationships with all of the key partners
    listed in Section I (i.e., first responders, etc.).

-   Determine who will be responsible for opening unopened suspicious
    letters and packages in your facility, and establish a relationship
    with them (this may be a specially trained federal personnel or
    other first responders).

-   Establish relationships and protocols with the local Federal Bureau
    of Investigation (FBI) WMD Coordinator concerning suspicious powders
    and liquids, or make sure that your first responders have done so.

-   Ensure that the first responder organization(s) are ready, willing,
    and able to follow the established protocols, including these
    guidelines, and that they have relationships with the other key
    partners.

Many of the above preparedness activities and local government contacts
can be initiated through and coordinated with the Local Emergency
Planning Committee (LEPC) responsible for the mail center's geographic
location. LEPC contact information can be found at
http://www.epa.gov/ceppo/lepclist.htm.

[Training and rehearsal]{.underline}: All mail center security
procedures should describe how current and new mail center workers will
be trained and how they will routinely rehearse various plans and
scenarios. Signs should be posted in every mail center that list
suspicious characteristics and that clearly identify whom to contact for
each of the various types of threats.

[X-ray inspection and suspicious characteristics]{.underline}: Before
sorting or internal delivery, all mail delivered to federal agencies
should be inspected by an x-ray machine operated by trained personnel.
Small facilities should consider partnering with a larger facility to
inspect by x-ray. **All deliveries from couriers and express carriers
(e.g., FedEx) should be x-rayed as well.** In addition, mail center
workers must monitor the mail continuously for suspicious
characteristics (See Appendix C for the standard list of suspicious
characteristics). As described below, procedures must be in place, with
continual training and rehearsal, for dealing with any mail that appears
suspicious.

[Communications]{.underline}: Security procedures should specifically
identify the agency managers and agency public affairs officials who
will coordinate all internal and external communications in the event
that a threat appears to be credible. Security procedures should also
ensure that:

-   Internal and external audiences are identified in advance;

-   All available information is communicated in a timely manner;

-   Everyone is sending the same message;

-   All facts are confirmed with competent authorities;

-   Designated communicators also have designated backups;

-   Local union officials are involved;

-   Local public health and local law enforcement officials are included
    in the communications chain;

-   Messages are crafted so that all personnel can easily understand the
    information; and

-   Results of any laboratory tests are communicated as quickly and
    completely as possible, including detailed, quantified results
    whenever quantitative tests were used; in any case, you should
    provide details about the nature of the tests that were used and the
    limitations, if any, of the test methods and results.

Security procedures should also identify which audiences may be informed
of threats before they have been confirmed; e.g., local health officials
may want to know that samples have been taken for analysis. They should
also include specific information on prompt communication of any
available test results, specifying the testing methods used, and
explaining the limitations, if any, of both the results and the testing
methods.

The Occupational and Health and Safety Administration (OSHA) requires
that a Health and Safety Plan (HASP) be developed for any clean-up of
hazardous materials (see http://www.osha.gov/dep/anthrax/hasp/).

Additional Considerations in Preparation are listed in Appendix B.

## 

## IV. Identifying and assessing biological threats

When working with mail and identifying if a mail piece is suspicious or
the FBI needs to be contacted, **two scenarios should be reported to the
FBI WMD Coordinator.** Initially, the designated first responder such as
the Federal Protective Service (FPS), Defense Protective Service, or
other first responder, would be notified. They would then ensure that
the FBI WMD Coordinator is notified in these two scenarios:

> **[Opened mail that is leaking a suspicious liquid or powder, or mail
> that has a suspicious odor]{.underline}**: If you open a letter or
> package and see an unknown material, or if an unknown material is
> leaking from the mail as a liquid, powder, or odor, *do not try to
> clean it up or otherwise disturb it*. Set the mail down on a stable
> surface and call the first responder designated to respond to this
> type of threat.
>
> **[Opened mail that contains a written threat]{.underline}:** If
> anyone in the organization opens a letter or package *with or without
> powder* and discovers a written threat, such as a note that says "You
> have been infected with anthrax," put the package or letter down on a
> stable surface and call the first responder designated to deal with
> this type of threat. The mail center supervisor or the first responder
> must ensure that the FBI local WMD Coordinator is notified in either
> of these events.

A much more common scenario is a letter or package that is unopened and
appears suspicious. Consider the following:

> **[Unopened mail]{.underline}:** Whenever a mail center worker
> identifies an [unopened]{.underline} package or letter as
> "suspicious", a mail center supervisor or specially trained employee
> should examine the mail piece to confirm that it meets the criteria
> established for the location. If confirmed, *do not open it.* A
> supervisor or designated mail center worker who is trained to confirm
> the identification must be available during all working hours.
>
> Next, determine if the mail piece is addressed to a person who
> actually works in the facility. If so, and if the addressee can be
> located in a reasonable period of time, contact the addressee and ask
> him or her to identify the package. If the addressee recognizes the
> package and is certain it is not threatening, deliver it. If the
> addressee does not recognize the package, or if you cannot locate the
> addressee, attempt to contact the individual listed on the return
> address to verify the contents of the package. If you successfully
> contact the sender of the package, ask them to provide a description
> of the contents, intended addressee, and the reason it was mailed to
> your location. Provide this information to the addressee for further
> verification.
>
> If the addressee does not recognize the package, or if you cannot
> locate the addressee, *do not open it.* The supervisor or designated
> mail center worker should call the previously designated first
> responder (that is, the organization you have identified as the right
> one for the specific threat in hand). This first responder will be
> responsible for opening the package in a controlled environment and
> following the appropriate protocol for evaluation of the threat. A
> "controlled environment" may be a glove box, hood with negative
> airflow and HEPA filters on the exhaust airflow, or a similar device.
> When identifying the first responder who will open suspicious letters
> or packages, make sure they have such a device available.

**[Mail that contains an unidentified secondary
container]{.underline}:** If x-ray inspection shows a secondary
container that may contain an unknown material, or if you open a letter
or package and discover such a container, *do not open or otherwise
disturb the secondary container*. Treat the secondary container as
suspicious, unopened mail. As above, first call the addressee and see if
they can identify the container. If he or she cannot be located, then
call in the first responder designated to open suspicious mail.

The USPS is irradiating much of the mail that is being delivered to
federal agencies in the Washington DC, metropolitan area. The procedures
for identifying and assessing biological threats are the same, as
described above, for locations where the USPS is irradiating mail. That
is, irradiation does not change the process described in this section.

# 

# V. Managing biological threats that appear credible

In the event that a trained first responder, after reviewing the
situation, determines that a possible biological threat may actually be
present (i.e., a biological agent may have been released into the
workplace, or a biological agent may be present in a package or envelope
that has been opened as discussed above), the **first responder** should
take the following steps or ensure that these activities are performed
where appropriate:

-   Turn off the ventilation system, fans or window air conditioners for
    the area of potential release.

-   Turn off any high-speed mail processing equipment that may have
    handled the suspicious mail piece.

-   Make sure that the suspicious substance is not disturbed by covering
    it or bagging it if appropriate.

-   Keep everyone out of any room(s) that may have been contaminated.

Whenever a first responder determines that a biological threat may be
present, he or she should **immediately call the FBI** Field Office and
ask to speak to the Weapons of Mass Destruction (WMD) coordinator. The
FBI website is [http://www.fbi.gov](http://www.fbi.gov/).

The FBI WMD coordinator will respond to the scene and will, in
conjunction with other federal, state, local, and internal experts,
conduct a threat assessment to determine the credibility of the threat.
FBI, as Lead Federal Agency for crisis management, will tailor the
response to the level of threat. If the threat appears credible, the FBI
will take appropriate steps that match the threat including:

-   Site assessment;

-   Arranging for definitive testing at one of the Laboratory Response
    Network (LRN) laboratories;

-   Arranging for or coordinating appropriate packaging, chain of
    custody procedures and transportation of samples to the laboratory;

-   Informing public health, hazmat, and other local authorities about
    the situation;

-   Notifying the U. S. Postal Inspection Service, whenever it appears
    that the threat was delivered through the U. S. Postal Service, and
    then ensuring that origin and tracking information is obtained from
    the mail piece (ideally, digital photographs of the front and back);

-   Identifying and listing the names of anyone who may have been
    exposed to the suspicious substance;

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-   Asking all potentially exposed persons to wash their hands.

Bombs, dangerous chemicals, and radiological threats, by their very
natures, require immediate, crisis-level responses. Biological agents,
on the other hand, may not make people sick instantaneously. Most
biological weapons have an incubation period, which ranges from 3 to 7
days. Results will usually be available from the LRN laboratory in about
2 days, so there will be enough time to form and coordinate an
appropriate response, including treatment when appropriate, before
symptoms appear. Dramatic steps such as closing large buildings are not
appropriate until the LRN results have been received.

In the event that microbiological culture in an LRN laboratory produces
a positive result, decisions regarding quarantine and treatment of
potentially exposed individuals must be made as an integrated process
involving local public health, law enforcement, hazmat first responders,
and local federal management. Preplanning, training, and rehearsal are
essential to making this work. The process for responding in these
circumstances is laid out in detail in the Technical Assistance for
Anthrax Response" issued by the National Response Team (www.nrt.org ).

[Communications]{.underline}: Occupational Safety and Health
Administration (OSHA) standards require employers to make health and
safety information available to any employee who requests it. As
discussed above, all information relevant to apparent and credible
biological threats should be provided to employees as quickly as
possible, preferably without waiting for a request. Health and Safety
Plans, also required by OSHA regulations, must include provisions for
sharing health and safety information.

[Record keeping]{.underline}: Federal agencies must keep careful and
complete records of all apparent biological threat events, including all
advice received from first responders, law enforcement, and public
health officials, and the specific content of any information conveyed
to employees and the public.

Chain of evidence protocol requires that a name, date, time, and
signature be obtained every time custody of a suspicious material or
sample for laboratory analysis changes hands.

[Decontamination]{.underline}: The level of decontamination effort
depends on the credibility of the threat. If a competent authority has
determined that the threat is not credible and not a criminal hoax, then
a simple cleanup is sufficient, using any appropriate household or
industrial cleaning agent.

In the case of a credible threat, the material should not be cleaned up.
It is important to make sure that enough material remains for:

-   Laboratory analysis, if necessary;

-   Use as criminal evidence, regardless of whether the threat is
    ultimately determined to be infectious, toxic, or simply a criminal
    hoax.

U. S. Postal Service regulations do not require that a mail center
deliver every piece of mail. Mail is occasionally contaminated with
noxious materials that are not otherwise hazardous. Once these
guidelines have been followed to their conclusion, federal mail centers
are free to dispose of mail as they see fit.

Of course, if a threat proves to be real, the Environmental Protection
Agency, local public health authority, and many others will have to be
involved in the cleanup and decontamination.

[Irradiated Mail]{.underline}: The USPS is irradiating much of the mail
that is being delivered to federal agencies in the Washington DC,
metropolitan area. This should be considered in the site assessment
phase carried out by the first responder. The risk to workers would be
lessened if the biological agent has been destroyed by irradiation. The
threat, if credible, still would be referred to the FBI.

## 

## VI. Sampling, testing, and sanitization

Vendors seeking to sell a wide variety of measures to monitor, test, and
sanitize the mail frequently contact federal mail managers. All
available scientific evidence indicates that the following are
inappropriate for routine use in mail centers for assessing or managing
any type of biological threat:

-   Hand-held immunoassay devices

-   Polymerase Chain Reaction (PCR) rapid field tests

-   Autoclaves

-   Ultra-violet treatment

-   Ethylene oxide treatment

-   "Sniffers"

-   Routine sampling

-   Routine culturing of samples

-   Quarantining mail pending the results of routine sampling and
    testing.

**GSA recommends, therefore, that these devices and processes not be
used in federal mail centers or by first responders to federal mail
centers.**

Please note that this recommendation applies only to *routine use in
federal mail centers.* Some of these technologies are entirely
appropriate for use in other situations, including:

-   Assaying or cleanup of actual biological attacks;

-   Research and development that may lead to development of assay
    devices or treatments that are appropriate for mail center use in
    the future;

-   Development of devices for use in military situations;

-   U. S. Postal Service mail processing facilities; or

-   Defined, high threat situations, where a scientifically validated
    technology platform is selected and installed as part of a carefully
    developed concept of operations, including consequence management
    that fits the technology.

The Department of Health and Human Services (DHHS) has released guidance
on use of these methods indicating that the effectiveness of these
methods is unsatisfactory. A copy of this guidance is attached as
Appendix E.

On this issue, Dr. John H. Marburger, Director, OSTP, signed a
memorandum on July 19, 2002, which included the following statement:

"Until further notice, the Office of Science and Technology Policy
advises that federal agencies cease issuing any new procurement
requests, task orders, purchase orders, or contracts for the purchase of
new equipment or services that may detect, sample, test or filter air
for *Bacillus anthracis* as the method for assaying suspicious mail, or
for routine environmental sampling of mail rooms. The Department of
Defense will continue to procure military standard biological detection
equipment following the current statutory regulations under which the
Department operates. "

Dr. Marburger's memorandum remains in effect. To view the entire
memorandum, see Appendix F.

### 

###  

### Summary

Since September 11, 2001, all levels of government have cooperated to
strengthen our nation's security and defend against terrorism. The
United States Postal Service (USPS) has instituted a number of
procedural changes to minimize the threat to their workers and mail
center workers across the United States. The most critical of these is
cleaning high-speed mail processing equipment with HEPA-equipped vacuum
cleaners instead of blowers.

Together, these changes have established a reasonable level of
protection for mail center workers. Solid, believable information gives
people the confidence to make informed choices, and informed choice
gives a sense of control over our destiny. The Interagency Working Group
has designed this document to help federal agencies perform their
critical missions for the American people.

![](media/image1.png)

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

G. Martin Wagner

Associate Administrator

Appendixes

A --Working Group Members

B -- Additional Considerations of Preparing

C -- Standard List of Suspicious Characteristics (FBI)

D -- Useful Websites

E -- Statement By the Department of Health and Human Services

F -- Memo from Dr. Marburger

**Appendix A: Working Group Members**

The members of the Interagency Working Group that prepared these
guidelines represent the:

Department of Defense

> Program Executive Office for Chemical/Biological Defense Command
> (CBDCOM)

U.S. Army

U.S. Military Postal Service Agency

Department of Energy

Lawrence Livermore National Laboratory

Department of Health and Human Services

Office of the Secretary for Public Health Preparedness

Department of Homeland Security (DHS)

Federal Protective Service

Science and Technology Directorate

Department of Justice

Federal Bureau of Investigation

Department of Treasury

Internal Revenue Service

Environmental Protection Agency (EPA)

General Services Administration (GSA)

Office of Governmentwide Policy

Public Buildings Service Chicago

New York State Department of Health

Office of Science and Technology Policy (OSTP)

U.S. Postal Service

Postal Inspection Service

# Appendix B: Additional Considerations in Preparation 

[Mail center design]{.underline}: All but the smallest mail centers
should be placed in enclosed, dedicated rooms, with controlled access
and limited points of entry. If possible, mail centers should be located
near loading docks. This will allow the mail to travel directly to the
mail center from the outside and reduce the impact that any potentially
contaminated mail will have on the rest of the building. Wherever the
volume of mail, the security assessment, and a cost-benefit analysis
make it appropriate, the mail center should have its own air handling
and ventilation system, including High Efficiency Particulate Air (HEPA)
filters, and procedures for shutting down ventilation. A HEPA filter
system reduces, and in some instances may eliminate bacteria in the
environment; it will also control the paper dust that is inherent in
handling mail.

Nonporous materials should be used to construct and furnish the mail
center. For example, tile floors should be used instead of carpeting,
and hard plastic or metal furniture should be installed instead of
fabric-covered furniture. Gloss or semi-gloss paint should be used on
all painted surfaces. A lighting level of 100 foot-candles is
recommended to assist personnel in identifying suspicious mail. A
telephone should be installed within the mail center, where possible, so
personnel can contact the proper individuals when necessary.

[Disabled]{.underline} employees: Every federal agency must provide a
safe working environment for all employees, including those with special
needs. Security procedures should specifically address communications
with Individuals who may need assistance during an emergency. Additional
information on emergency preparedness for disabled employees can be
found at the web site of the National Organization of the Disabled at
**http://www.nod.com.**

[Contractors]{.underline}: Contracts for mail center operations or
related functions should specify security procedures that the contractor
and contract personnel must follow.

[Gloves, masks/respirators, and protective clothing]{.underline}: Gloves
and respirators (masks) should be made available, but not required, for
any mail center workers or others who process mail, because wearing
gloves or a respirator eases the fears of some workers. Other protective
clothing is unnecessary except to protect workers' clothing from dust
and other dirt. Where respirators are used, a written respiratory
program must be established that conforms to the requirements of OSHA's
respiratory protection standard as specified in 29 CFR 1910.134(c)(2).
See http://[www.osha.gov](http://www.osha.gov/).

[The Laboratory Response Network for Bioterrorism (LRN)]{.underline} is
a network of governmental (local, state and federal laboratories that
have been trained by the Centers for Disease Control and Prevention
(CDC) to process samples by well-established and validated procedures.
These laboratories utilize LRN standard protocols for testing and must
successfully complete periodic proficiency testing challenges sent from
the CDC. The LRN was formed as a self-organized group through the
efforts of the CDC and the Association of Public Health Laboratories
(APHL). Through the APHL, local, state, national and global health
leaders are linked to promote the highest quality laboratory practices
worldwide.

[To identify the appropriate LRN laboratory when developing the security
plan, call the APHN at 202-822-5227.]{.underline}

![](media/image2.png){width="5.997222222222222in"
height="8.154861111111112in"}

**Appendix D: Useful Websites**

Bureau of Alcohol, Tobacco and Firearms (BATF) --
[www.atf.treas.gov](http://www.atf.treas.gov/)

Centers for Disease Control and Prevention (CDC) -
[www.bt.cdc.gov](http://www.cdc.gov/)

Council on Foreign Relations - Homeland Security Questions and Answers
on Biological Attacks - www.cfrterrorism.org/security/

Department of Homeland Security --
[www.Whitehouse.gov/homeland](http://www.Whitehouse.gov/homeland) or
[www.dhs.gov/dhspublic/](http://www.dhs.gov/dhspublic/)

Federal Bureau of Investigation (FBI) --
[www.fbi.gov](http://www.fbi.gov/)

Federal Emergency Management Agency (FEMA) --
[www.fema.gov](http://www.fema.gov/)

Federal Protective Service - www.dhs.gov/

General Services Administration (GSA) --
[www.gsa.gov](http://www.gsa.gov/)

GSA Mail Communications Policy Office - www.gsa.gov/mailpolicy

Office of Personnel Management - publishes questions and answers on
federal employees personnel issues, etc. - www.opm.gov

U.S. Department of Labor (DOL), Occupational Safety and Health
Administration (OSHA) - www.osha.gov

U.S Postal Service (USPS) -- [www.usps.com](http://www.usps.com/)

USPS Postal Inspection Service -
[www.usps.com/postalinspectors](http://www.usps.com/postalinspectors)

## Workplace Risk Pyramid, OSHA - [**www.osha.gov/bioterrorism/anthrax/matrix**](http://www.osha.gov/bioterrorism/anthrax/matrix) 

## Appendix E

**STATEMENT BY THE DEPARTMENT OF HEALTH AND HUMAN SERVICES**

**Regarding Hand-Held Assays for Identification of *B. Anthracis*
Spores\
**

[Purpose]{.underline}

To provide law enforcement, fire services, emergency managers and other
first responders with guidance regarding the purchase and use of
hand-held assays used for detecting anthrax spores and other biological
agents.

## Summary

The U.S. Department of Health and Human Services at this time recommends
against use by first responders of hand-held assays to evaluate and
respond to an incident involving unknown powders suspected to be anthrax
or other biological agents.

#### Background

In recent months, Federal, State and local first responders have had to
evaluate numerous samples of white powdery substances to determine if B.
anthracis (anthrax) spores are present. In some cases, field tests
showed an apparent "positive" result and this led to the quarantine,
isolation or decontamination of people. When these samples were referred
to a reference lab in the Laboratory Response Network (LRN), they were
found to be negative through microbiological culturing and molecular
methods. The devices used for the initial field tests included tickets
and strips from at least four vendors. Problems resulted from a variety
of factors, such as testing of caustic or harsh chemicals or the
performance of tests by inadequately trained personnel.

[Discussion]{.underline}

Biological agent field test kits are, at this time, not sufficiently
accurate for on-scene decision making in the field. Besides the high
number of false positive results, hand-held assays also yield negative
results on samples that are truly positive (false negatives). In formal
terms, the sensitivity of such assays are in the range of 100,000 spores
whereas a culture may detect one spore.

In contrast to situations with chemical exposure where rapid decision
making (minutes) can be crucial to the protection and treatment of
individuals, there are no examples of biological exposure where
decision-making cannot wait for the results of validated laboratory
procedures (1-2 days). Any perceived benefit of using currently
available hand-held assays fall short of the costs of unnecessary
remedial actions and amplified public concern.

No Federal agency certifies or approves these devices. The FBI and CDC
have recently evaluated commercially available hand-held assays for the
detection of B. anthracis. These studies confirm the low sensitivity of
such assays and their potential to produce false-positive results with
non-anthrax bacteria and chemicals. The performance of handheld assays
for the detection of biological agents other than B. anthracis has not
been evaluated and their use is also not recommended at this time.

[Conclusions]{.underline}

Until results are obtained that would warrant the use of hand-held
assays, DHHS recommends:

(1) hand-held assays systems [not]{.underline} be used for the
    assessment of suspected biological samples;

(2) Whenever a biological agent is suspected, a unified command should
    assess the credibility of the situation and determine an appropriate
    response. The unified command should include fire services, public
    health, the FBI's Weapons of Mass Destruction Coordinator, and law
    enforcement;

(3) Substances that are found to be a credible public health threat by
    the unified command should be screened in the field for volatile
    organic compounds (VOC), pH, explosives, and radiation, and then
    sent to an appropriate laboratory in the Laboratory Response Network
    (LRN) for testing. First responders and local public health programs
    need to establish protocols to provide this support and logistics of
    the response. Besides testing of samples in an LRN laboratory, the
    protocol should include a system for identification and follow-up of
    the potentially exposed population and a joint communication plan
    for the public and media relations. Since exposure to airborne
    anthrax spores is potentially life threatening, all
    [credible]{.underline} threats should be handled appropriately in a
    timely manner.

References:

1\. "CDC Health Advisory: Hand-Held Immunoassays for Detection of
Bacillus anthracis Spores." October 18, 2001

> <http://www.bt.cdc.gov/DocumentsApp/Anthrax/10182001HealthAlertPM/10182001HealthAlertPM.asp>

2\. "Use of Onsite Technologies for Rapidly Assessing Environmental
Bacillus anthracis Contamination on Surfaces in Buildings." CDC MMWR Vol
50 Number 48. December 7, 2001.
<http://www.cdc.gov/mmwr/PDF/wk/mm5048.pdf>

3\. "Approved Tests for the Detection of Bacillus anthracis in the
Laboratory Response Network."
<http://www.bt.cdc.gov/DocumentsApp/Anthrax/ApprovedLRNTests.asp>

**Appendix F: Memorandum from Dr. John H. Marburger, III**