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[Federal Register Volume 90, Number 11 (Friday, January 17, 2025)]
[Presidential Documents]
[Pages 6773-6776]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-01471]



                        Presidential Documents 



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

[[Page 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,

[[Page 6774]]

                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;

[[Page 6775]]

(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

[[Page 6776]]

(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.
                
                
                    (Presidential Sig.)

                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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