[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