BY RICK EMERY
The United States was still reeling in the aftermath of the September 11, 2001, terrorist attacks when a new threat emerged just days later. Letters laced with anthrax paralyzed mail service across the country, killing five people and sickening 17 more. More than 10,000 people were deemed to be at risk and underwent antibiotic prophylaxis. Within a short time, emergency response to biological threats and field biotesting were added to the fire service’s list of responsibilities. This article discusses current biotesting standards and sampling protocols that influence public safety response to incidents suspected of involving biological materials. Primary emphasis is on emergency response to suspicious packages where a biological threat may be present.
HISTORICAL PERSPECTIVE
Prior to 2001, very few emergency response agencies were fully prepared to handle biothreat calls. Although there had been several biothreat-type incidents throughout the country, they certainly were not number one on most responders’ radar until anthrax letters started to appear in September 2001.
Literally overnight, emergency responders were inundated with calls involving what became euphemistically known as “white powder” incidents. Local, state, and federal assets were overwhelmed with tens of thousands of calls involving both hoaxes and good intent calls.
This was a new kind of response for most responders, and local hazardous materials teams were quickly pressed into service. In the absence of any national strategy or tactical guidance, the learning curve was steep, and mistakes were made. Initially, there was little factual information available, and most hazmat teams treated these “white powder” calls with extreme caution. Wearing fully encapsulating, chemical vapor protective suits (i.e., Level A) was not uncommon during the first few days, but it was quickly determined that personal protective equipment supplies were limited and this level of response could not be sustained for very long. Fire department hazardous materials response teams (HMRTs) quickly developed operating procedures to handle this new threat.
The Centers for Disease Control and Prevention (CDC) had made great strides since forming the Laboratory Resource Network (LRN) in 1999, but there was still much work to be completed before a truly robust national laboratory system was in place and ready to meet any challenge. As a result, laboratory confirmatory testing was unable to keep up with this surge, and many samples could not be tested in a timely manner to meet the public safety challenges fire service and law enforcement personnel faced. Some metro fire departments reported receiving hundreds of “white powder” calls every day for several weeks. First responders were expected to do something, but biological field-testing equipment was virtually nonexistent in 2001.
The CDC subsequently released information stating that anthrax was infectious at 8,000 to 10,000 Colony Forming Units (CFUs). In comparison, one of the only commercially available biodetection field systems at that time listed the system’s detection threshold at 100,000 CFUs. That detection threshold was 10 times the infectious dose, and there were no official independent factual test data to confirm that the system actually worked. That manufacturer later changed the detection threshold to a range of 250,000 to 500,000 CFUs. One experienced responder said, “… that is like having a combustible gas meter that alarmed at 30 to 50 times over the lower explosive limit. What good does that do anyone?”
Driven by the need to protect their communities, emergency responders spent literally millions of tax dollars on equipment to address the public safety risks. Unfortunately, when the scientific testing and processes came later, many units that were on the marketplace could not pass the scientific testing. With the benefit of hindsight, public safety responders learned that in the absence of performance standards and third-party testing for any field-deployable biological testing equipment, purchasers were at the mercy of exaggerated marketing claims.
Exacerbating the technical problems was the fact that there were also opposing incident priorities between public safety and public health agencies. For example, law enforcement focused on processing the crime scene and collecting evidence to prosecute and convict the guilty party. Law enforcement officials were also concerned that fire department hazmat teams could adulterate or destroy potential evidence by decontaminating suspected white powder scenes using bleach.
Likewise, there were public health officials concerned with community health issues who did not believe that first responders should collect samples to conduct field screening. Some believed that first responders could consume too much of the available sample and not leave enough sample for a public health lab to test. Adding to the problems and uncertainty were reports of emergency responders deciding to decontaminate civilians and recommending medical intervention without consulting public health officials.
Although many of these views were valid, first responders continued to be challenged with the need to determine the immediate impact of a biothreat incident on their local community and make tactical decisions. A common refrain many in the fire service noted was that the fire service is expected to assess a problem in seconds to minutes, but lab testing can take hours to days. Even today, it is still not reasonable for a fire department to wait on a scene for 24 to 72 hours until lab results are available. Likewise, it is very difficult for an incident commander to justify isolating a group of civilians or shutting down a vital facility for several days while the sample is tested in the laboratory. Again, this was true during all of the low-credibility threat calls in the fall of 2001 and early 2002 and continues to be an issue in some areas today.
Adding to this mix were rumors of false positives generated by first responders and laboratories alike, not to mention the substantial apprehension regarding potential false negatives. By all accounts, there was considerable room for improvement to make the biothreat emergency response system more efficient and effective. Conflicting priorities among agencies did not always lend themselves to fostering good relations. Although the various disciplines did not always work well together, a great deal of progress was made once a number of the key players realized that these issues were not going to go away and everyone started to understand and appreciate the other agencies’ concerns. Although it might not be 100 percent accurate to say that everyone agrees on all the issues today, it is fair to say that there has been a lot of thoughtful compromise to get this far.
BIOTHREAT RESPONSE: THE EVOLUTION
Fast forward to 2011, some 10 years after the initial wave of white powder calls. As a result of collaborative efforts among the public health, law enforcement, and emergency response communities, a national strategy and operational baseline have evolved. Unlike 2001, there is a body of science that can support the strategic and tactical guidance that now exists. Consider these basic points:
- Assessment of suspicious materials for biological threats that first responders conduct in the field is considered presumptive, whereas laboratory testing is confirmatory. Having a sufficient sample that is correctly collected from the field, packaged, and transported to the lab is a critical piece of this confirmation process.
- First responders are going to use all of the tools in their toolbox to assess the immediate hazards and risks that they may encounter when dealing with an unknown suspicious powder or package. Coordinating with public health and law enforcement officials provides confidence in the decisions that are made using these tools.
How did we evolve to this point? The U.S. Department of Homeland Security Science and Technology Directorate (DHS S&T) formulated a plan to move toward an enduring national strategy that included a standardized sampling protocol and third-party testing of field biological detection equipment.
In 2003, the DHS S&T contracted with AOAC International to evaluate the performance of equipment first responders use to screen these so-called “white powders.” AOAC International is a 124-year-old independent third-party scientific organization recognized worldwide for bringing together stakeholders to reach consensus on analytical methods needed in the areas of food, agriculture, biological threat agents, and the environment. The AOAC conducts validation studies through the AOAC® Official Methods Program to ensure that the methods work as intended and are repeatable in many laboratories.
The AOAC facilitated the task force for Bacillus anthracis to develop the testing standards and performance criteria. This task force included representatives from the first responder community, industry, academia, public health, and various government agencies. The manufacturers of commercially available equipment were also invited to participate in this testing program.
The original standard protocol for collecting and preserving samples of suspicious powders was developed at the request of the U.S. DHS by a multiagency team coordinated by the National Institute of Standards and Technology (NIST) and AOAC International. The protocol outlined a two-step process for collecting bulk samples of suspicious powder from a solid surface such as a desktop or a table and the collection of residual material with swabs for use in field evaluation. They were referred to as Method A and Method B, respectively.
Method A is used first to collect as much of the sample as possible to send to the LRN for confirmatory analysis. The LRN conducts scientific testing to “rule in or rule out” the suspected biological sample and to provide identification, if possible. The sampling standard dictates how the sample is to be collected and packaged to protect the responders, individuals transporting the sample, and lab personnel who will ultimately need to open the package to test the sample.
Method B is employed once Method A has been completed if the first responders have field biodetection capability. Method B instructs the responder how to properly collect a sample for integration with a field test of the remaining residue. This protocol addresses many important issues, such as employing aseptic techniques to protect the sample from adulteration. It adapts the “clean man/dirty man” concept that most HMRT members understand into a scientific lab technique addressed as “Sampler” and “Assistant Sampler.” It also addresses the contentious issues of sample collection for public safety testing vs. actionable public health testing and law enforcement evidentiary requirements.
As part of the initial protocol development process, tests were conducted at the Dugway (UT) Proving Grounds. In addition, 11 national laboratories undertook testing the current generation of biological testing equipment to determine if the systems were able to meet the rigorous test parameters. Several manufacturers of commercially available equipment participated in this program.
In evaluating the various biological testing systems, many factors had to be considered:
- 1. Inclusivity (ability to detect a variety of B. anthracis strains).
- 2. Exclusivity (ability to distinguish B. anthracis strains from non-B. anthracis strains).
- 3. Sensitivity (reliability of assays when known numbers of B. anthracis spores are present). High sensitivity means fewer false negatives.
- 4. Specificity (rate of correct results when assays are challenged with known numbers of non-B. anthracis spores). High specificity means fewer false positives.
- 5. Matrix effects (cross reactions with common hoax materials).
- 6. Preparation effects (reliability of assay results when spore samples are prepared using different preparation procedures).
Other important factors of concern to the end user include portability (size, weight, battery life, and so on), initial costs, sustainment costs, ease of use, training requirements, and ruggedness. The tests also subjected the equipment to ultraviolet light testing, drop testing, and accelerated aging using vibration testing to simulate being stored on an apparatus.
It is interesting to note that while field biodetection devices were typically called “handheld assays” (HHAs), the science and technology have advanced past “handheld” devices. For example, a state-of-the-art immunoassay detection system uses a fluorometer reader to enhance sensitivity. Specificity is dependent on many other factors, including the use of highly specific polyclonal and monoclonal antibodies. Using the fluorescent reader avoids many of the sensitivity problems associated with the earlier readers that used reflective technology.
When all of the tests were completed, only one manufacturer passed. Response Biomedical was awarded the AOAC Certificate of Performance on October 22, 2004.
The next question was to determine if the certified equipment would work as well in the field as it had in the laboratories. A follow-up program was then initiated to validate the sampling standard using the RAMP® system under field conditions at the Dugway Proving Grounds. Six teams representing a cross-section from the response community were trained in both the new sampling standard and the RAMP® detection system. These five-person teams wore chemical splash protective clothing and powered air-purifying respirators (i.e., EPA Level C) to conduct repetitive tests over several weeks.
This validation testing involved depositing an exact known amount of live anthrax on a nonporous test “tile” and then recovering as much of the anthrax as possible using the sampling standard Method A. By weighing the anthrax that had been deposited and then weighing the amount recovered, it was possible to calculate the efficiency of the sample collection technique. These repetitive tests were conducted using various types of “tiles” to simulate different surfaces encountered in the field. The test “tiles” included stainless steel, food-grade painted wood, tile, plastic, rubber, concrete, and finished wood. The tests were carefully controlled for scientific precision, and the statistics for all this hard work were impressive.
The original sampling standard was reviewed in 2010 and subsequently re-released as American Society of Testing & Materials (ASTM) Standard E2458-10, Standard Practice for Bulk Sample Collection and Swab Sample Collection of Visible Powders Suspected of Being Biological Agents from Nonporous Surfaces.Recommendations for developing new, general guidelines to facilitate sample collection and coordination with a receiving laboratory came from members of two focus groups from the first responder and public health communities. With feedback from a coalition of local, state, and federal agencies, NIST was able to revise the original standard and develop new operational guidance for initial response to suspected biothreats (ASTM E2770-10, Standard Guide for Operational Guidelines for Initial Response to a Suspected Biothreat Agent).
Because many of the organizations involved in responding to these incidents have different concerns and needs for sample, broad acceptance of the new ASTM E2458-10 standard and ASTM E2770-10 guidance is critical. For example, first responders initially assess a biothreat scenario by performing a risk assessment in coordination with public health and law enforcement, including the LRN and Federal Bureau of Investigation (FBI), as appropriate. The primary concern of this assessment is protecting the public while preserving the chain of custody in case the incident is a confirmed biothreat event and samples are used as evidence in a criminal investigation.
The ASTM E2458-10 sampling standard is available to emergency responders at no charge on the Responder Knowledge Base (RKB) (www.rkb.us). You must be a registered user to initially sign in and then check the area labeled “RKB Recommends” for the link to the ASTM E54 standards. That will lead you to the page to “Click Here To Access Standards.” Click again to acknowledge the warning that you are about to leave the RKB site. Finally, click on the E2458-10 link to download a pdf of the standard.
The ASTM E2770-10 companion guidance document is available at no charge on that same ASTM page. ASTM E2770-10 was developed to assist jurisdictions in establishing best practices when planning for and responding to biothreat incidents. This document is an excellent starting point if you do not already have a standard operating procedure (SOP) for sample collection and integration of detection technologies as well as a good reference for comparison if you do have an SOP. Download both ASTM documents, and use them in concert to complement your response procedures.
“The new guidance explains that first response agencies should do the legwork now to establish relationships they will need in the event of an incident,” says Jayne Morrow, an environmental engineer at NIST, who led the revision project. “For example, it provides recommendations regarding who should be at the planning table, and it establishes contact phone numbers for expert support and to coordinate, thereby enabling first responders to effectively address one of these situations.”
Morrow explains that first responders have reported that they like this guidance because it is appropriate for any jurisdiction, regardless of its size and resources, and that the key message is, “through response coordination and communication, we can effectively deal with an event in a timely and an appropriate manner.”
(Note: The Responder Knowledge Base is an excellent free resource for many additional types of important information.)
SPADA
In addition to the ASTM sampling standard and operational guideline, the DHS S&T continues to work on consensus performance standards and third-party testing of technologies first responders use to screen suspicious samples in the field. In 2007, the DHS S&T contracted with AOAC International to establish the Stakeholder Panel on Agent Detection Assays (SPADA). SPADA is a voluntary consensus standards body made up of more than 100 stakeholders from federal, state, and local governments; the first response and public health communities; and industry. The body was originally tasked to develop standards and a process for third-party testing of commercially available detection tools employed by private sector end users. In 2009, SPADA was asked to address the need for consensus performance standards and the third-party testing detection tools of first responders.
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| (1) Training Session: A “white powder” stimulant sample is being collected with a microbrush during a training session. (Photos by author.) |
To date, SPADA has established standards for the testing of polymerase chain reaction (PCR)-based technologies that detect aerosolized B. anthracis, Yersinia pestis, Francisella tularensis, Burkholderia psuedomallei, and Burkholderia mallei. These standards include a number of reference material panels, method performance criteria, and test protocols required to evaluate the performance of these tools. More applicable to first responders, SPADA has also established standards for the testing of the tools they use in the field to screen suspicious powders. These tools include immuno-based HHAs and PCR-based technologies that detect B. anthracis and HHAs that detect ricin.
In addition to the defining of the standards required for evaluation, SPADA has made important strides in further recognizing the need to tie performance certification of a technology to a concept of operations and appropriate training and proficiency testing of the user to create a complete mission capability.
BIOTESTING TECHNOLOGY—2011
A great deal of field biodetection equipment has been available on the commercial market since 9/11, but tests using field-deployable equipment are still considered presumptive. Emergency responders should have a credible reason to suspect that a certain bioagent may be present so that a test for that specific agent is conducted. If multiple agents are suspected, then several tests may be run.
Today, field-deployable equipment available to first responders typically falls into two basic categories: immunoassays and PCR. Currently, one system in each category has passed the rigorous testing program outlined previously.
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| (2-3) The sample is dosed and tested. |
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Immunoassay technology has been around for decades and uses an antigen-antibody binding process. Typically, these systems employ a consumable test cartridge and a hardware reader. The sensitivity using a certified immunoassay system is quite good, and these systems are affordable for many fire departments with a need for a field biodetection capability. To date, the RAMP® system is still the only immunoassay system to pass the testing. The system can be purchased for under $10,000, including in-service training at the end user’s facility. Each test costs $17 to $25.
PCR is more “high tech” compared to immunoassay technology. A PCR system amplifies the sample DNA to provide more sensitivity, but it is also more expensive. The RAZOR® system by Idaho Technologies is currently undergoing the SPADA testing process. A RAZOR system costs approximately $38,500; the reagents for each test cost around $200.
Many complex issues are being resolved as all of these efforts move forward. The hope is that this work will provide responders with reliable biological testing equipment that is affordable and accurate—and yields actionable results.
KEY ISSUES
Some of the key issues responders must consider in responding to biological threats and acquiring biofield-testing equipment include the following:
- 1. Local HMRTs are the logical end users of field biodetection testing, since in most locations no other agency is positioned to match the response capabilities of the local fire department.
- 2. First responders performing field biodetection must follow the accepted protocols to collect and screen samples in the field. They must be trained to use the equipment properly, and operators must remain technically proficient.
- 3. Field biodetection equipment must be third-party tested and certified to confirm that the product meets consensus standards. With this knowledge, the end user can make an informed decision to purchase the best equipment for its needs. Unfortunately, past history has shown that trusting unconfirmed claims can be problematic and liability is a justifiable concern.
- 4. Taxpayers have a right to expect to get the most value for their dollar these days. Grant funding should only be available to purchase certified equipment that has been able to pass these stringent tests.
- 5. The involved parties must continue working together for the public good. It should not be an adversarial “we vs. them” situation. Meet with your FBI weapons of mass destruction coordinator and public health colleagues before an emergency so everyone knows what is expected. If you train together, you will know what real-world capabilities and limitations to expect.
● RICK EMERY is the president of Emery & Associates, Inc. He is a retired career fire captain, served 10 years as the coordinator of the Lake County (IL) Hazardous Material Response Team, and has more than 40 years of experience in emergency response and training. Validated as a subject matter expert by the Department of Defense in 1997, Emery conducted training for the Domestic Preparedness Program, Department of Justice and Department of Homeland Security. He is a principal member of the National Fire Protection Association Technical Committee on Hazardous Materials Response Personnel, a member of the International Association of Fire Chiefs Hazardous Materials Committee, and a member of the Stakeholder Panel on Agent Detection Assays. He is the training contractor for Response Biomedical and a hazmat instructor in the United States and Canada.
