The opioid crisis in the United States began in the late 1990s as a result of extensive overuse of prescribed medications. This crisis—or, should we say, full-on epidemic—is still raging today, and has since evolved to include abuse of synthetic opioids (like fentanyl), obtained both through medical prescription and by illicit means. According to the Centers for Disease Control and Prevention (CDC), over a 6-year period between 2013 and 2019, synthetic opioid-involved deaths in the U.S. increased by 1,040% from 1.0 to 11.4 individuals per 100,000. While the relationship between drug overdoses and the COVID-19 pandemic requires further investigation, these devastating statistics, paired with provisional data and other emerging research suggests that the pandemic has only exacerbated the opioid crisis.
Another critical consequence of the widespread prevalence of synthetic opioids is the alarming frequency with which first responders, including emergency medical and law enforcement personnel at all levels, encounter them. Unknown or unexpected contact with a synthetic opioid such as fentanyl or a related compound presents a safety hazard for first responders if they are not prepared with the proper protective equipment. Reliable detection is one way the Science and Technology Directorate (S&T) is working to protect the nation’s first responders as they deal with the crisis on the front lines, and standards play a key role in ensuring the integrity of such vital detection equipment. Where the latter is concerned, DHS S&T is pleased to provide some breaking news.
In July, ASTM International, one of the largest standards development organizations in the world, published three new standards for the field detection of fentanyl and fentanyl-related compounds. S&T funded and provided subject matter expertise for the development of all three standards and participated in the drafting and balloting of each of the three documents:
- ASTM E3243-21 Standard Specification for Field Detection Equipment and Assays Used for Fentanyl and Fentanyl-Related Compounds;
- ASTM E3289-21 Standard Guide for Using Equipment and Assays for Field Detection of Fentanyl and Fentanyl-Related Compounds; and
- ASTM E3290-21 Standard Test Method for Establishing Performance of Equipment and Assays for Field Detection of Fentanyl-Related Compounds.
“This suite of standards is an example of a standards-enabled capability, providing the underpinning standards infrastructure supporting integration of a new capability into operations,” said DHS Standards Executive Philip Mattson, who chairs ASTM’s Committee on Homeland Security Applications.
This effort was a true collaboration between S&T, via its’ Office of Mission and Capability Support and Office of Science and Engineering, and the Pacific Northwest National Laboratory (PNNL), industry professional, and other key stakeholders to produce a set of standards that promote the protection of those on the frontline of the opioid crisis through a specification, guide and test method for field detection equipment.
While the new standards are similar in title and they do reference each other, they are three distinct standards. Standard specification ASTM E3243-21 provides system designers, manufacturers, integrators, procurement personnel, end-users, practitioners, and responsible authorities a common set of parameters to match the capabilities of chemical detection tools with user needs for their specific application. Standard guide ASTM E3289-21 provides the end-user—those detecting these illicit and dangerous compounds in the field—with information on the optimal use as well as critical limitations of detection equipment. Finally, standard test method ASTM 3290-21 details different methods for the testing of field detection equipment in a lab setting, specifically sample preparation, analysis protocols, and procedures to use when examining equipment performance.
“The development of fentanyl detection standards was a critical first step on the path to providing our first responders with more robust detection capabilities that will better inform and protect them from hazardous substances they encounter in the field,” said Dr. Rosanna Anderson, who leads S&T’s Opioid/Fentanyl Detection program.
The newly published standards will be put into effect almost immediately through a S&T-led research and development effort with PNNL; they will be used to support collection of reference spectra to build out instrument libraries with approximately 50 Drug Enforcement Agency controlled substances including fentanyl, fentanyl analogues, and other emerging synthetic drugs. A follow-on test and evaluation event to assess the upgraded instrumentation will follow the procedures outlined in standard test method ASTM 3290-21. With the participation of 15 commercial vendors, submitting 20 different field portable opioid detection systems, this will result in a comprehensive reference library that will be provided to first responders who currently use these instruments at no cost and as a publicly accessible report on the performance assessment results. The ability of first responders to identify fentanyl, its analogs and other synthetics drugs using reliable equipment, verified through standardized methods, and access a reference library that catalogs the data in one place enables them to effectively plan and conduct operations while simultaneously increasing responder safety.
“This project is truly a win-win for first responders and manufacturers of field chemical detection equipment,” said Rich Ozanich, the lead researcher at PNNL who developed the standards and is leading the development of expanded instrument libraries and assessment of instrument performance. He added, “having these expanded libraries will improve responder capability to identify new drugs they encounter and respond in a more effective manner.”
S&T was mandated by Congress (through the Office of Management and Budget Circular A-119 on Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities) to promote the development, publication, adoption and use of standards developed through the voluntary consensus process that fulfill critical mission needs, which this effort clearly demonstrates.
“This effort integrated the requirements and needs of the stakeholder and user community,” stated Mattson, “with rules and regulations (R&R) and supporting standards development to enable delivery of this much needed tool to the response community.” Not only do these new standards comply with the mandate, more importantly they translate to a real-world benefit for end-users and hopefully many lives saved.