Regulatory Relief for Certain Stationary Sources To Promote American Security With Respect to Sterile Medical Equipment

Proclamation 10959 of July 17, 2025

Regulatory Relief for Certain Stationary Sources
To Promote American Security With Respect to Sterile
Medical Equipment

By the President of the United States of America

A Proclamation

1. The use of ethylene oxide is critical for the
sterilization of medical equipment, which protects
patients against infection and the transmission of
disease. The continued utilization of ethylene oxide by
commercial sterilization facilities is essential to
ensuring that our Nation provides its sick and injured
with the best outcomes possible--an objective that is
at the forefront of the Federal Government's
responsibility to the American people.

2. On April 5, 2024, the Environmental Protection
Agency published a final rule, pursuant to section 112
of the Clean Air Act, 42 U.S.C. 7412, titled National
Emission Standards for Hazardous Air Pollutants:
Ethylene Oxide Emissions Standards for Sterilization
Facilities Residual Risk and Technology Review, 89 FR
24090 (EtO Rule). The EtO Rule imposes new emissions-
control requirements on commercial sterilization
facilities.

3. The EtO Rule places severe burdens on commercial
sterilization facilities. About 50 percent of all
sterile medical devices in the United States are
sterilized with ethylene oxide, and sterilization with
ethylene oxide may be the only method of sterilizing
many medical devices without damaging them. By
requiring compliance with standards premised on the
application of emissions-control technologies that do
not exist in a commercially viable form, the EtO Rule
risks making critical sterile medical devices
unavailable to care for patients in our civilian and
military medical systems. The current compliance
timeline as set forth at 89 FR 24101-24103 of the EtO
Rule will likely force existing sterilization
facilities to close down, seriously disrupting the
supply of medical equipment. Our Nation would be unable
to adequately supply the sterilized medical equipment
that medical personnel need to safely treat their
patients in hospitals, operating rooms, and other
medical facilities. In short, the current compliance
timeline would undermine our national security.

NOW, THEREFORE, I, DONALD J. TRUMP, President of the
United States of America, by the authority vested in me
by the Constitution and the laws of the United States,
including section 112(i)(4) of the Clean Air Act, 42
U.S.C. 7412(i)(4), do hereby proclaim that certain
stationary sources subject to the EtO Rule, as
identified in Annex I of this proclamation, are exempt
from compliance with the EtO Rule for a period of 2
years beyond the EtO Rule's relevant compliance dates
(Exemption). This Exemption applies to all compliance
deadlines established under the EtO Rule applicable to
the stationary sources listed in Annex I, with each
such deadline extended by 2 years from the date
originally required for such deadline. The effect of
this Exemption is that, during each such 2-year period,
these stationary sources will remain subject to the
emissions and compliance obligations in effect prior to
the issuance of the EtO Rule. In support of this
Exemption, I hereby make the following determinations:

a. The technology to implement the EtO Rule is not
available. Such technology does not exist in a
commercially viable form sufficient to allow

implementation of and compliance with the EtO Rule by
the compliance dates set forth in the EtO Rule.
b. It is in the national security interests of the
United States to issue this Exemption for the reasons
stated in paragraphs 1 and 3 of this proclamation.

IN WITNESS WHEREOF, I have hereunto set my hand this
seventeenth day of July, in the year of our Lord two
thousand twenty-five, and of the Independence of the
United States of America the two hundred and fiftieth.

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