Ethylene Oxide: Technical Reviews and Outreach to Potentially Affected Communities

Status Report — Viant Medical, Inc., Grand Rapids, Mich.

As EPA pursues its mission to protect public health and the environment, addressing ethylene
oxide (EtO) remains a major priority for the Agency. EPA's National Air Toxics
Assessment (NATA), released in August 2018, identified a number of areas (census tracts) with
potentially elevated risk from continuous exposure, over 70 years, to EtO in the outdoor air.
NATA estimated these risks based on EtO emissions from 2014, which were the most recently
available at the time.

NATA is a screening-level analysis that is intended to identify pollutants or areas for closer
examination. Because of this, additional work is needed to better understand emissions in
areas that NATA identified as potentially having elevated risk. EPA has been supporting its state
air agency partners as they conduct that work and identify opportunities for reducing EtO
emissions from individual facilities, while the Agency reviews its national regulations for
industrial facilities that emit EtO. Actual risks today may be higher or lower than NATA
estimated due to several factors, including updated or more refined facility emissions
information, or recent facility changes such as the installation of pollution controls.

The information below describes the technical analyses conducted for Viant Medical, Inc. in
Grand Rapids, Mich, as part of the follow-up work conducted since NATA was issued in August
2018. It also summarizes outreach to nearby communities about the NATA results. EPA is
providing this information, in part, in response to the EPA Office of Inspector General's March
31, 2020, Management Alert which called on EPA to provide information to the 25 communities
that NATA identified as potentially having the highest risk from EtO emissions.

Technical reviews conducted:

Viant Medical, Inc. is located in Grand Rapids, Mich. Until the end of 2019, Viant provided EtO
sterilization services to the medical device industry.

•	Closure: Viant stopped EtO sterilization on December 31, 2019, as part of state-led
enforcement settlement. This settlement resulted in EtO emission reductions of 1,200
pounds per year. As part of the settlement, Viant also paid a penalty of $110,000 and
conducted monthly air sampling through February 2020.

•	Air Monitoring: The Michigan Department of Environment, Great Lakes and Energy
(EGLE) and Viant each conducted air sampling. All results are available here.

•	Inspection: EGLE and EPA conducted a joint inspection on October 12, 2018 that helped
inform EGLE's enforcement action. EGLE's inspection and compliance documents are
available here.

Outreach conducted:

•	Website: EGLE developed a Viant website and posted materials in English and Spanish.

•	Public Meetings: EGLE held public meetings on March 6, 2019 and October 23, 2019.
EPA attended the October 2019 meeting.

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