[House Document 119-75]
[From the U.S. Government Publishing Office]
119th Congress, 1st Session - - - - - - - - - - - - - House Document 119-75
PROCLAMATION REGARDING NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR
POLLUTANTS: ETHLYLENE OXIDE EMISSIONS STANDARDS FOR STERILIZATION
FACILITIES RESIDUAL RISK AND TECHNOLOGY REVIEW
__________
MESSAGE
from
THE PRESIDENT OF THE UNITED STATES
transmitting
A PROCLAMATION PROVIDING EXEMPTION FOR CERTAIN STATIONARY SOURCES FROM
COMPLIANCE WITH THE FINAL RULE PUBLISHED BY THE ENVIRONMENTAL
PROTECTION AGENCY TITLED ``NATIONAL EMISSION STANDARDS FOR HAZARDOUS
AIR POLLUTANTS: ETHYLENE OXIDE EMISSIONS STANDARDS FOR STERILIZATION
FACILITIES RESIDUAL RISK AND TECHNOLOGY REVIEW'', PURSUANT TO 42 U.S.C.
7412(i)(4); PUBLIC LAW 91-604, SEC. 4(a); (84 STAT. 1686).
July 22, 2025.--Message and accompanying papers referred to the
Committee on Energy and Commerce and ordered to be printed
To the Congress of the United States:
Consistent with applicable law, including section 112(i)(4)
of the Clean Air Act, 42 U.S.C. 7412(i)(4), I hereby report
that I have issued a proclamation providing exemption for
certain stationary sources from compliance with the final rule
published by the Environmental Protection Agency 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),
which imposes new emissions-control requirements on commercial
sterilization facilities.
As reflected in the proclamation of July 17, 2025
(Regulatory Relief for Certain Stationary Sources to Promote
American Security with Respect to Sterile Medical Equipment)
(Proclamation), 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.
In the Proclamation, I determined that 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. I further
determined in the Proclamation that it is in the national
security interests of the United States to issue an exemption
from the EtO Rule to certain stationary sources subject to the
EtO Rule, as identified in Annex I of the Proclamation. This
exemption applies to all compliance deadlines established under
the EtO Rule, with each such deadline extended by 2 years from
the date originally required for such deadline.
I am enclosing a copy of the Proclamation I have issued and
Annex I thereto.
Donald J. Trump.
The White House, July 21, 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.
Donald J. Trump.