PARTNER PROFILE
minutes with
Ren Salerno
by Nancy Maddox, MPH, writer
Reynolds (“Ren”) Salerno, PhD, has an
international reputation for excellence in
promoting the safe, secure and responsible
handling of dangerous biological agents in
laboratory settings. Before becoming director
of the Centers for Disease Control and
Prevention’s (CDC) Division of Laboratory
Systems (DLS) in 2016, he served as
senior manager for biological sciences and
technologies at Sandia National Laboratories,
where he oversaw laboratory quality systems,
biosafety, biosecurity, biocontainment and
infectious disease diagnostics.
Salerno is a US delegate to Technical
Committee 212 of the International
Organization for Standardization and
has served on the board of directors of
the International Federation of Biosafety
Associations (and was previously its vice
chairman). He has been a technical advisor
to both the World Health Organization and
the US Defense Science Board’s Task Force on
Deterring, Preventing, and Responding to the
Threat or Use of Weapons of Mass Destruction.
He currently serves on APHL’s Biosafety
and Biosecurity Committee and is the CDC’s
liaison to the APHL Board of Directors. Salerno
received a bachelor’s degree from Middlebury
College and a PhD from Yale University.
14
LAB MATTERS Fall 2019
What prompted your interest in public
health?
2014 was a big year for me professionally.
Not only did Ebola arrive in the United
States, but there were back-to-back
biosafety incidents at CDC and biosecurity
issues at the National Institutes of Health.
These events made us realize that prompt
diagnosis, biocontainment, and infection
control were critical competencies for
all US hospitals and clinical laboratories.
At that time, many clinical laboratories
in the United States declared that they
would refuse to test any suspect Ebola
specimen—which I believed was a
disregard of their duty that harkened back
to the initial response to the HIV crisis of
the 1980s. Add all that up, and I suddenly
saw a public health career as a real
opportunity to support CDC and advance
biorisk management in a way I couldn’t
do from outside the federal government.
How has the field of biorisk
management evolved over the last
decade?
Hopefully, we’re in the midst of a
paradigm shift from an agent-based
perspective on biosafety to a risk-based
perspective—essentially a move from
an almost exclusive focus on assessing
hazards in a laboratory setting to a
broader understanding of what all can
go wrong and how best to prevent those
things. The historical paradigm is to
simply implement the recommended
biosafety level (BSL) for the agent you’re
working with. This generally makes
sense in a research environment where
you know what you’re working with, but
makes little sense in a clinical or public
health laboratory environment where
you usually don’t know the agent you’re
working with because you’re trying to
identify the agent. For example, Ebola is
defined as a BSL-4 agent. But, like most
clinical laboratories in the US, Dallas
Presbyterian—where the first US Ebola
patient walked into the emergency
room—has no BSL-4 capabilities. By
this reasoning, Dallas Presbyterian
and almost every other hospital and
clinical laboratory in the country would
be incapable of testing specimens
from a suspected Ebola patient. Yet the
clinical laboratory at Dallas Presbyterian
successfully tested Ebola specimens from
two Ebola patients without transmission
to any laboratory staff, and the same was
true at Emory, Nebraska and Bellevue—
none of which has a BSL-4 laboratory.
Biorisk management is not just about the
agent; it’s about the people, procedures,
training, equipment, instrumentation,
environment, and everything else that
could possibly contribute to something
going wrong. Context matters. All of those
elements have to be continually evaluated
and managed. Risk assessment, risk
mitigation, and performance evaluation
must become day-to-day activities,
not an annual report that sits on an
administrator’s shelf.
What major changes in US laboratory
systems, public and private, can we
expect over the next 10 years?
Clinical laboratory testing is big business.
We perform 14 billion tests per year in the
US, and that number has increased 5 to 10
percent every year over the last decade.
That’s greater than the 1 percent average
annual growth of the US population. In
addition, the number of FDA-approved
clinical laboratory tests—not including
new genetic testing products—has
doubled over the last 20 years. Laboratory
testing is becoming increasingly
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