Presidential Documents

Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Presidential Documents 6773 

Memorandum of January 16, 2025 

Orderly Implementation of the Air Toxics Standards for 

Ethylene Oxide Commercial Sterilizers 

Memorandum for the Administrator of the Environmental Protection 

Agency and the Secretary of Health and Human Services 

By the authority vested in me as President by the Constitution and the 

laws of the United States of America, it is hereby ordered as follows: 

Section 1. Policy. The strengthened and updated Clean Air Act standards 

for ethylene oxide (EtO) emitted into the air from commercial sterilizing 

facilities issued by the Environmental Protection Agency (EPA) on April 

5, 2024, National Emission Standards for Hazardous Air Pollutants: Ethylene 

Oxide Emissions Standards for Sterilization Facilities Residual Risk and 

Technology Review, Final Rule, 89 FR 24,090 (Apr. 5, 2024) (‘‘EtO Rule’’), 

achieved a new milestone in my Administration’s efforts to protect public 

health for all Americans and to advance the objective of my Administration’s 

Cancer Moonshot initiative to prevent cancer before it starts. EtO has been 

associated with elevated cancer risks in communities around the United 

States and can be particularly harmful to children. The loss of loved ones 

from environmentally related cancer is a tragedy that the Nation can and 

must work together to end, once and for all. 

The EtO Rule was issued after careful consideration of public comments 

and public hearings. In this rule, EPA set standards under section 112 

of the Clean Air Act, as amended (the ‘‘Act’’) (42 U.S.C. 7401 et seq.), 

to control emissions from commercial sterilizers through the use of demonstrated and achievable pollution control technologies and practices. These 

standards will significantly reduce emissions of the toxic air pollutant EtO. 

The EtO Rule applies to facilities that sterilize medical products, including 

medical devices and pharmaceuticals. Sterilization is critical to maintaining 

a safe supply of medical devices for patients and hospitals and providing 

health care to millions of Americans to help them stay healthy and fight 

diseases, including cancer. Consequently, EPA worked closely with the Department of Health and Human Services, including the Food and Drug 

Administration, to develop a final rule that protects communities exposed 

to pollution from sterilization facilities while also mitigating and managing 

the potential risk of any medical device supply disruptions. 

EPA concluded that sterilization facilities will be able to install the appropriate technology to meet the standards of the EtO Rule before the compliance 

deadlines mandated by the Act. The EtO Rule also recognized that the 

President’s authority under section 112(i)(4) of the Clean Air Act, 42 U.S.C. 

7412(i)(4), to exempt individual facilities from compliance for a set period 

of time may provide an important mechanism to address the possibility 

that a facility may be unable to install all appropriate technology before 

the compliance deadline. 89 FR at 24,103. It is of vital national importance 

to ensure the reduction of EtO emissions to the level that EPA determined 

is required to protect public health pursuant to the Clean Air Act, while 

also avoiding the national security and public health effects that could 

result from a significant disruption to the medical device supply chain. 

It is the policy of my Administration to safeguard the reliability of our 

Nation’s supply of safe medical products. To advance orderly implementation 

of the EtO Rule, I am therefore establishing a process, provided below, 


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for considering requests for Presidential exemptions, the duration of which 

shall be as short as possible and no longer than two years. This process 

will ensure consideration of such requests in the exceptional circumstances 

in which a commercial sterilizer can demonstrate that, notwithstanding due 

diligence and best efforts, it will be unable to meet a covered standard 

or limitation required by the EtO Rule before the compliance deadline due 

to the unavailability of control technology for the facility, leading to likely 

shutdown of the facility, and the best available information demonstrates 

that the shutdown of the facility will likely lead to a serious disruption 

to the supply of medical products, such as medical devices and pharmaceuticals, necessary for America’s national security and public health. 

To achieve the EtO Rule’s critical health protections as soon as practicable, 

while safeguarding the supply of safe medical products from disruption 

that would compromise the health and welfare of the American people, 

I direct you to take the following actions: 

Sec. 2. Implementation of a Process for Considering Presidential Exemptions. 

The Administrator of the EPA (Administrator) shall receive requests for 

a Presidential exemption from a standard or limitation in the EtO Rule 

under section 112(i)(4) of the Act (42 U.S.C. 7412(i)(4)), review them, and 

advise the President regarding whether to grant them through the following 

process: 

(a) Any commercial sterilizer seeking such an exemption shall submit 

a request to the Administrator no earlier than 12 months and no later 

than 4 months before the compliance deadline for which an exemption 

is sought. The request shall include: 

(i) specific information of sufficient detail to enable verification of the 

reason or reasons that the technology to implement the applicable standard 

or limitation is unavailable for installation and that, notwithstanding its 

due diligence and best efforts, the facility cannot be brought into compliance before the compliance deadline for the covered standard or limitation 

(e.g., contracts, documentation of communication with vendors or suppliers); 

(ii) a plan for procuring, installing, and operating the technology as soon 

as feasible in order to achieve compliance with the EtO Rule, and an 

assurance as described in subsection (h)(ii) of this section; 

(iii) a list of all available practicable measures (i.e., technological and 

operational) that have already been taken or that are planned to advance 

compliance and additional measures, if any, that will be implemented 

to reduce the emissions of EtO and resulting risks during the exemption 

period; 

(iv) a list of any alternative steps available, in progress, or already taken 

to try to avoid the need for additional time for compliance; 

(v) the type or types of products sterilized at the facility, the volume 

of products sterilized at the facility, and the facility’s annual sterilization 

capacity; and 

(vi) the name, title, and signature of the responsible official who is certifying the accuracy of the request. 

(b) In reviewing an exemption request, and the information provided 

pursuant to this section, the Administrator, in consultation with the Secretary 

of Health and Human Services (Secretary), shall consider: 

(i) whether the technology to implement a covered standard or limitation 

will be unavailable in time for installation and operation of the technology 

at a specific facility before the compliance deadline for such standard 

or limitation, due, for example, to shortages of labor, parts, control technology supply, supply-chain disruption, or other factors out of the facility’s 

control; 

(ii) the amount of time needed for installation and operation to occur 

in order to achieve compliance with the EtO Rule; 


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(iii) the risk of a serious disruption to the supply of medical products 

(including pharmaceuticals and medical devices) should the facility be 

required to temporarily pause sterilization activities or reduce capacity 

until installation and operation can occur (including any potential alternatives to assure a sufficient supply of sterilization and sterilized medical 

products); 

(iv) the potential effect of any such disruption on public health and 

welfare, and any other information that may be relevant to an evaluation 

of whether granting an exemption is in the national security interests 

of the United States; and 

(vi) any other information that the Administrator, in consultation with 

the Secretary, deems relevant. 

(c) No later than 30 days after receiving a request pursuant to subsection 

(a) of this section, the Administrator shall confirm receipt of the request, 

notify the requester of any additional information needed to evaluate the 

request, set a deadline of no later than 15 days for the requester to provide 

the requested information, and provide public notification that the request 

was submitted (including the name of, the location of, and any other information regarding the facility requesting the exemption that the Administrator, 

in consultation with the Secretary, deems relevant and appropriate to publish). 

(d) As soon as practicable and no later than 30 days after receiving 

all necessary information to evaluate a request pursuant to this section, 

the Administrator, in consultation with the Secretary, shall provide the 

Chairman of the Council on Environmental Quality (CEQ) with the request 

and accompanying information from the requester, any additional information 

that the Administrator deems relevant, and a recommendation regarding 

whether an exemption is warranted, including the basis for the recommendation, and if recommending that the President grant an exemption: the recommended duration, and any other accompanying terms or conditions (such 

as a schedule for status reports regarding planned steps and progress to 

achieve compliance with the EtO Rule). 

(e) As soon as practicable and generally within 45 days after receiving 

a recommendation from the Administrator pursuant to subsection (d) of 

this section, the Chairman of CEQ, in consultation with the Assistant to 

the President for National Security Affairs, the Assistant to the President 

for Economic Policy, the Assistant to the President for Domestic Policy, 

the Director of the Office of Pandemic Preparedness and Response Policy, 

and the Director of the Office of Science and Technology Policy, shall 

advise the President concerning the request for an exemption. 

(f) As expeditiously as practicable after the grant or denial of any exemption 

by the President under this process, and no later than 10 days after such 

a grant or denial, the Administrator shall notify the applicant. 

(g) Within 60 days of the grant of any exemption by the President under 

this process, the Administrator shall make publicly available online the 

name of, location of, and any other appropriate and relevant information 

regarding the facility receiving the exemption and the duration of any exemption, and shall submit to Congress the report required by section 112(i)(4) 

of the Act (42 U.S.C. 7412(i)(4)) on behalf of the President. 

(h) The Administrator shall, as appropriate: 

(i) provide technical assistance to any facility that receives an exemption 

to promote compliance with the EtO Rule; 

(ii) seek information and assurance from any facility that requests an 

exemption that the facility will use its best efforts and will take reasonable 

and appropriate steps to demonstrate diligent action to install and operate 

necessary technology as expeditiously as practicable (including to fulfill 

any accompanying terms or conditions) to achieve compliance with the 

EtO Rule; and 


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(iii) inform the Chairman of CEQ when installation of such technology 

is complete. 

Sec. 3. Federal Coordination. The Secretary, in consultation with the Administrator, shall consider taking additional steps, as appropriate, to further 

advance the goal of protecting the public from cancer and other harms 

from EtO exposure, including spurring innovation to reduce exposure to 

EtO and other carcinogenic air pollutants and to expand access to safe, 

effective, and reliable alternative methods for sterilization of medical equipment and pharmaceuticals that do not depend on EtO, and continuing to 

strengthen the resilience of our Nation’s medical supply chain. Within 2 

years of the date of this memorandum, the Secretary shall provide a report 

to the Chairman of CEQ regarding progress toward this directive and any 

steps taken or planned. 

Sec. 4. General Provisions. (a) Nothing in this memorandum shall be construed to impair or otherwise affect: 

(i) the authority granted by law to an executive department or agency, 

or the head thereof; or 

(ii) the functions of the Director of the Office of Management and Budget 

relating to budgetary, administrative, or legislative proposals. 

(b) This memorandum shall be implemented consistent with applicable 

law and subject to the availability of appropriations. 

(c) This memorandum is not intended to, and does not, create any right 

or benefit, substantive or procedural, enforceable at law or in equity by 

any party against the United States, its departments, agencies, or entities, 

its officers, employees, or agents, or any other person. 

(d) The Administrator is authorized and directed to publish this memorandum in the Federal Register. 

THE WHITE HOUSE, 

Washington, January 16, 2025 

[FR Doc. 2025–01471 

Filed 1–16–25; 2:00 pm] 

Billing code 6560–50–P 


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