Battelle Prepares to Guide Medical Device Companies Through New Federal, State and International Regulations on “Forever Chemicals”
29 Julio 2024 - 10:02AM
Business Wire
Battelle’s longstanding research, laboratory analysis and
consulting expertise in Per- and Polyfluoroalkyl Substances (PFAS)
are being applied in a new capacity as the pervasiveness of the
chemical class becomes better known and more broadly regulated.
From federal regulations such as the U.S. Environmental Protection
Agency’s (EPA) Toxic Substances Control Act (TSCA) and the
Comprehensive Environmental Response, Compensation and Liability
Act (CERCLA) to state-specific and international existing or
developing PFAS bans, medical device manufacturers are now facing
mounting record-keeping, recording and reporting requirements
regarding supply chain uses, production volumes and waste handling
and disposal.
Known for their chemical and heat resistance, durability,
lubricity and biocompatibility, PFAS have been integral in
manufacturing various products, including medical devices. However,
their persistence in the environment and potential health risks
have led to sweeping regulatory actions globally that are starting
to impact the medical device industry.
More than a dozen states have already passed laws affecting
product manufacturers and retailers across specific sectors, while
some states, such as Maine and Minnesota, are implementing
far-reaching legislation that will consider “all products” and take
effect between 2024 and 2032.
As regulations progress, device manufacturers may be challenged
with reformulating products to eliminate or reduce PFAS content
without sacrificing performance or safety. These companies may be
faced with increased costs associated with compliance, encompassing
testing, certification and potential redesign of products. Finally,
there may be reputational risk as consumers and healthcare
providers become more informed and concerned about PFAS.
“Battelle can help medical device manufacturers evaluate current
and developing regulations and position themselves as proactive
leaders in the market,” said Shalene Thomas, Battelle’s Emerging
Contaminants Program Manager. “That includes understanding the
regulatory landscape, identifying and addressing PFAS substances in
products, facilities and processes, sourcing and developing
alternative materials, ensuring supply chain transparency, engaging
with regulators to better understand waste and environmental
liabilities, and communicating effectively with stakeholders.”
Battelle’s team of experienced scientists and researchers has
been studying PFAS for nearly two decades and has developed
innovative solutions to advance the testing, analysis and
destruction of PFAS.
Battelle operates one of the leading PFAS testing facilities in
the country and is one of a limited number of laboratories
accredited to test more challenging, non-traditional matrices for
PFAS such as landfill leachate.
As a leader at the forefront of site assessment and remediation
for this emerging class of chemicals, Battelle conducts critical
research to better understand the fate and transport of PFAS
compounds and how contaminated sites can best be remediated to
minimize and eliminate environmental and human health
exposures.
"Battelle doesn't hesitate to tackle complex challenges in any
of the industries we serve,” said Mel Sych, Chief Commercial
Officer. “Our mission is to support our clients optimally,
providing services and solutions that help maintain business
continuity and minimize supply chain disruption as new regulations
take hold.”
In 2023, Battelle successfully spun off Revive Environmental a
company that is deploying the PFAS Annihilator® to destroy PFAS in
landfill leachate and aqueous film-forming foam (AFFF) firefighting
foams at contaminated sites.
Battelle also has developed PFAS Signature®, an innovative
method for understanding source attribution and delineations to
determine the fate and transport of these chemicals, as well as
source tracking and differentiation of AFFF sources from non-AFFF
sources. The insights this tool provides can help companies make
better, more informed decisions.
About Battelle
Every day, the people of Battelle apply science and technology
to solving what matters most. At major technology centers and
national laboratories around the world, Battelle conducts research
and development, designs and manufactures products, and delivers
critical services for government and commercial customers.
Headquartered in Columbus, Ohio since its founding in 1929,
Battelle serves the national security, health and life sciences,
and energy and environmental industries. For more information,
visit www.battelle.org.
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version on businesswire.com: https://www.businesswire.com/news/home/20240729212926/en/
Katy Delaney, (614) 424-7208 delaneyk@battelle.org T.R. Massey,
(614) 424-5544 masseytr@battelle.org