Release Date: October 14, 2021
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.
For more information on S&T’s
standards portfolio, visit https://www.dhs.gov/science-and-technology/standards or
contact Standards@hq.dhs.gov.
Source: https://www.dhs.gov/science-and-technology/news/2021/10/14/feature-article-new-fentanyl-detection-standards-protect-first-responders
