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Presidential Memorandum

Orderly Implementation of the Air Toxics Standards for Ethylene Oxide Commercial Sterilizers

This memorandum establishes a formal process for commercial sterilizers to request Presidential exemptions from EPA's April 2024 ethylene oxide (EtO) emissions standards when compliance technology is unavailable and facility shutdown would disrupt medical device/pharmaceutical supplies. It directs EPA and HHS to coordinate on reviewing exemption requests with strict timelines, and requires HHS to report within 2 years on progress toward reducing EtO exposure and developing alternative sterilization methods.

Federal Register Open PDF 90 FR 6773

Impact dates

  1. HHS Secretary report to CEQ Chairman on progress toward reducing EtO exposure and alternative sterilization

  2. Earliest submission of exemption request (12 months before compliance deadline)

  3. EPA public disclosure and congressional report after exemption grant

  4. CEQ Chairman advice to President after receiving EPA recommendation

  5. EPA confirmation of receipt, notification of additional information needed, and public notification of request submission

  6. EPA recommendation to CEQ Chairman after receiving all necessary information

  7. Requester deadline to provide additional information requested by EPA

  8. EPA notification to applicant after Presidential grant or denial

Key directives

  • Establish process for Presidential exemptions under Clean Air Act section 112(i)(4) for EtO Rule compliance
  • EPA Administrator to receive, review, and advise President on exemption requests
  • Exemption requests must be submitted 12-4 months before compliance deadline
  • EPA to confirm receipt within 30 days, set 15-day deadline for additional information
  • EPA to provide recommendation to CEQ Chairman within 30 days of receiving all necessary information
  • CEQ Chairman to advise President within 45 days of receiving recommendation
  • EPA to notify applicant within 10 days of Presidential grant/denial
  • EPA to publicly disclose exemption details and report to Congress within 60 days of grant
  • EPA to provide technical assistance and seek compliance assurances from exempted facilities
  • HHS Secretary to consider steps to spur innovation in alternative sterilization methods
  • HHS Secretary to report to CEQ Chairman within 2 years on progress

Who is ordered

Timeline

Immediate

  • Memorandum effective upon signing; EPA authorized to publish in Federal Register
  • Process for exemption requests established

Near term (90d)

  • Exemption requests may begin arriving (12-4 months before compliance deadlines vary by facility)
  • EPA must begin implementing 30-day receipt confirmation and 30-day evaluation timelines

Long term

  • HHS report due to CEQ Chairman within 2 years on reducing EtO exposure and alternative sterilization methods
  • Exemptions granted may last up to 2 years maximum
  • Potential installation of control technology at exempted facilities
  • Long-term public health impacts from EtO emission reductions or continued exposure during exemptions

Risks & tensions

  • Maximum 2-year exemption duration creates pressure for technology installation but may extend public exposure
  • Tension between environmental justice (cancer risk in communities near facilities) and medical supply chain security
  • Exemption criteria ('unavailability of control technology,' 'serious disruption') involve subjective determinations
  • Process requires extensive interagency coordination (EPA, HHS, CEQ, NSC, economic/domestic policy, pandemic preparedness, OSTP) which may create delays or friction
  • Document states exemptions should be 'as short as possible' but also 'no longer than two years'—actual durations uncertain
  • No explicit limit on number of exemptions that may be granted, raising cumulative exposure concerns
  • HHS innovation directive is aspirational ('consider taking additional steps, as appropriate') with weak enforceability
Presidential Memorandum: Orderly Implementation of the Air Toxics Standards for Ethylene Oxide Commercial Sterilizers · Executive Orders