BD & Ethylene Oxide (EtO)

Why EtO?

From urinary catheters, PICC lines, oncology ports, breast biopsy needles, vascular and ureteral stents, feeding tubes and more, EtO is the ONLY option of sterilization for a large number of the medical devices manufactured and sterilized by BD due to material sensitivities and/or complexity of design.

Setting the Record Straight: The Facts

Environmental Protection Agency Study

In November 2019, the EPA released results of a comprehensive nationwide analysis of EtO levels across the country and found the average amount of EtO present in the air nationwide (also known as background levels) was between 0.2 and 0.4 micrograms of EtO per cubic meter of air1.

EtO levels measured in Covington by the Georgia EPD and BD are consistent with the average background levels
the EPA found nationwide in urban and rural areas that are not near sterilization facilities.

This means that people who work in, live near or drive by BD facilities in these communities every day are exposed to the same low levels of EtO found in every community sampled by the U.S. EPA.

1See Nov. 6, 2019 EPA update and data summary.

Average Background Levels of EtO Across the United States

Green: The Covington, Ga. average is the average of both EPD monitoring data from areas near BD’s sterilization facility and data from a third-party engineering company performing air monitoring around BD’s GDC in Covington, as required by EPD.

Average concentrations of EtO in Covington’s ambient air samples were 0.259 µg/m3, according to the combined results of data collected by the Georgia EPD and data from a third-party engineering company as required by GA EPD.

Usage in Perspective

0 %
of all EtO used by industry is to
make everyday products including
cosmetics, shampoos, laundry
detergents, clothing, and carpets. It's
even used to sterilize food.
0 %
is used to sterilize medical devices.
BD is just a very small
fraction of that.

The vast majority of ethylene oxide in our air comes from organic and industrial sources other than medical device sterilization facilities.

EtO is a byproduct of combustion, meaning it is produced by campfires, grills, cigars and cigarettes, auto exhaust, lawn mowers and many other sources. EtO is found in rural areas where there are swamps and decaying debris.

Even our own bodies produce EtO.

BD Technology: Investments and Upgrades

BD has been employing technology that is superior to many other medical sterilization facilities for more than 20 years.

  • In 1997, BD installed regenerative thermal oxidizers in Covington, the best available technology, to achieve greater than 99.9% EtO destruction
  • BD has been capturing back vent exhaust for more than 20 years, as well, even though the EPA rescinded this requirement

Since August 2019, BD has voluntarily invested nearly $40 million at the sites to fund several upgrades and process changes to further reduce emissions:

  • Installed and commissioned additional “dry bed” emissions control systems to capture “fugitive” EtO emissions and developed and implemented Leak Detection and Repair (LDAR) programs for outdoor components
  • Fugitive Emission Controls in Covington operational – March 2020
  • Fugitive Emission Controls in Madison operational – May 2020
  • Fugitive Emission Controls at the GDC operational – December 2020
  • Completed a comprehensive engineering study to determine the EtO residuals of product, package, and pallet for representative product to help more precisely characterize each facility’s emissions
  • Optimized cycle development (reduces EtO use per cycle)
  • The FDA approved this cycle for use for several product families by August 10, 2020. The cycle is currently in use for products where BD has received regulatory approval, and BD continues to optimize this cycle to minimize EtO.

BD Controls Emissions to Keep Communities Safe

  • BD is in compliance with all laws and regulations relative to EtO emissions as validated by the EPA and GA EPD
  • BD’s sterilization facilities historically emit 90% less EtO than the permit allows
  • BD achieves > 99.9% destruction of EtO; significantly better than the 99% the Clean Air Act requires
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