The date of enactment, referred to in subsec. (a)(11), probably means the date of enactment of Pub. L. 101–549, which amended this section generally and was approved
The Atomic Energy Act, referred to in subsec. (d)(9), probably means the Atomic Energy Act of 1954, act Aug. 1, 1946, ch. 724, as added by act Aug. 30, 1954, ch. 1073, § 1, 68 Stat. 919, which is classified principally to chapter 23 (§ 2011 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 2011 of this title and Tables.
The Federal Water Pollution Control Act, referred to in subsecs. (e)(5) and (m)(1)(D), (5)(D), is act June 30, 1948, ch. 758, as amended generally by Pub. L. 92–500, § 2,
The Toxic Substances Control Act, referred to in subsec. (k)(3)(C), is Pub. L. 94–469,
The Federal Insecticide, Fungicide and Rodenticide Act, referred to in subsec. (k)(3)(C), probably means the Federal Insecticide, Fungicide, and Rodenticide Act, act June 25, 1947, ch. 125, as amended generally by Pub. L. 92–516,
The Resource Conservation and Recovery Act, referred to in subsec. (k)(3)(C), probably means the Resource Conservation and Recovery Act of 1976, Pub. L. 94–580,
The Safe Drinking Water Act, referred to in subsec. (m)(1)(D), (5)(D), is title XIV of act
The Solid Waste Disposal Act, referred to in subsec. (n)(7), is title II of Pub. L. 89–272,
Section 303 of the Clean Air Act Amendments of 1990, referred to in subsec. (o)(4), probably means section 303 of Pub. L. 101–549, which is set out below.
The Clean Air Act Amendments of 1990, referred to in subsec. (q)(1)–(3), probably means Pub. L. 101–549,
The Emergency Planning and Community Right-To-Know Act of 1986, referred to in subsec. (r)(3), is title III of Pub. L. 99–499,
The Occupational Safety and Health Act, referred to in subsec. (r)(6)(C)(ii), (K), (L), probably means the Occupational Safety and Health Act of 1970, Pub. L. 91–596,
In subsec. (r)(6)(N), “section 6101 of title 41” substituted for “section 5 of title 41 of the United States Code” on authority of Pub. L. 111–350, § 6(c),
Section was formerly classified to section 1857c–7 of this title.
1999—Subsec. (r)(2)(D). Pub. L. 106–40, § 2(5), added subpar. (D).
Subsec. (r)(4). Pub. L. 106–40, § 2, substituted “Administrator—
“(A) shall consider—”
for “Administrator shall consider each of the following criteria—” in introductory provisions, redesignated subpars. (A) to (C) as cls. (i) to (iii), respectively, of subpar. (A) and added subpar. (B).
Subsec. (r)(7)(H). Pub. L. 106–40, § 3(a), added subpar. (H).
1998—Subsec. (n)(2)(C). Pub. L. 105–362 substituted “On completion of the study, the Secretary shall submit to Congress a report on the results of the study and” for “The Secretary shall prepare annual reports to Congress on the status of the research program and at the completion of the study”.
1991—Subsec. (b)(1). Pub. L. 102–187 struck out “7783064 Hydrogen sulfide” from list of pollutants.
1990—Pub. L. 101–549 amended section generally, substituting present provisions for provisions which related to: in subsec. (a), definitions; in subsec. (b), list of hazardous air pollutants, emission standards, and pollution control techniques; in subsec. (c), prohibited acts and exemption; in subsec. (d), State implementation and enforcement; and in subsec. (e), design, equipment, work practice, and operational standards.
1978—Subsec. (e)(5). Pub. L. 95–623 added par. (5).
1977—Subsec. (a)(1). Pub. L. 95–95, § 401(c), substituted “causes, or contributes to, air pollution which may reasonably be anticipated to result in an increase in mortality or an increase in serious irreversible, or incapacitating reversible, illness” for “may cause, or contribute to, an increase in mortality or an increase in serious irreversible, or incapacitating reversible, illness”.
Subsec. (d)(1). Pub. L. 95–95, § 109(d)(2), struck out “(except with respect to stationary sources owned or operated by the United States)” after “implement and enforce such standards”.
Subsec. (e). Pub. L. 95–95, § 110, added subsec. (e).
Committee on Energy and Commerce of House of Representatives treated as referring to Committee on Commerce of House of Representatives by section 1(a) of Pub. L. 104–14, set out as a note preceding section 21 of Title 2, The Congress. Committee on Commerce of House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh Congress,
Amendment by Pub. L. 95–95 effective
For termination, effective
Suits, actions, and other proceedings lawfully commenced by or against the Administrator or any other officer or employee of the United States in his official capacity or in relation to the discharge of his official duties under act
All rules, regulations, orders, determinations, contracts, certifications, authorizations, delegations, or other actions duly issued, made, or taken by or pursuant to act
Pub. L. 106–40, § 3(b), “(1) In this subsection, the term ‘accidental release’ has the meaning given the term in section 112(r)(2) of the Clean Air Act (42 U.S.C. 7412(r)(2)).“(2) Not later than 2 years after the date of enactment of this Act [“(3) Not later than 3 years after the date of enactment of this Act, the Comptroller General of the United States shall submit to Congress a report that—“(A) describes the level of compliance with Federal and State requirements relating to the submission to local emergency response personnel of information intended to help the local emergency response personnel respond to chemical accidents or related environmental or public health threats; and“(B) contains an analysis of the adequacy of the information required to be submitted and the efficacy of the methods for delivering the information to local emergency response personnel.”
Pub. L. 106–40, § 3(c),
Pub. L. 106–40, § 4, “(a) Not later than 180 days after the date of enactment of this Act [“(b) The Administrator of the Environmental Protection Agency may bring an action in the appropriate United States district court against any person who fails or refuses to comply with the requirements of this section, and such court may issue such orders, and take such other actions, as may be necessary to require compliance with such requirements.”
Pub. L. 101–549, title III, § 303, “(a) There is hereby established a Risk Assessment and Management Commission (hereafter referred to in this section as the ‘Commission’), which shall commence proceedings not later than 18 months after the date of enactment of the Clean Air Act Amendments of 1990 [“(b) The Commission shall consider—“(1) the report of the National Academy of Sciences authorized by section 112(o) of the Clean Air Act [42 U.S.C. 7412(o)], the use and limitations of risk assessment in establishing emission or effluent standards, ambient standards, exposure standards, acceptable concentration levels, tolerances or other environmental criteria for hazardous substances that present a risk of carcinogenic effects or other chronic health effects and the suitability of risk assessment for such purposes;“(2) the most appropriate methods for measuring and describing cancer risks or risks of other chronic health effects from exposure to hazardous substances considering such alternative approaches as the lifetime risk of cancer or other effects to the individual or individuals most exposed to emissions from a source or sources on both an actual and worst case basis, the range of such risks, the total number of health effects avoided by exposure reductions, effluent standards, ambient standards, exposures standards, acceptable concentration levels, tolerances and other environmental criteria, reductions in the number of persons exposed at various levels of risk, the incidence of cancer, and other public health factors;“(3) methods to reflect uncertainties in measurement and estimation techniques, the existence of synergistic or antagonistic effects among hazardous substances, the accuracy of extrapolating human health risks from animal exposure data, and the existence of unquantified direct or indirect effects on human health in risk assessment studies;“(4) risk management policy issues including the use of lifetime cancer risks to individuals most exposed, incidence of cancer, the cost and technical feasibility of exposure reduction measures and the use of site-specific actual exposure information in setting emissions standards and other limitations applicable to sources of exposure to hazardous substances; and“(5) and comment on the degree to which it is possible or desirable to develop a consistent risk assessment methodology, or a consistent standard of acceptable risk, among various Federal programs.“(c) Such Commission shall be composed of ten members who shall have knowledge or experience in fields of risk assessment or risk management, including three members to be appointed by the President, two members to be appointed by the Speaker of the House of Representatives, one member to be appointed by the Minority Leader of the House of Representatives, two members to be appointed by the Majority Leader of the Senate, one member to be appointed by the Minority Leader of the Senate, and one member to be appointed by the President of the National Academy of Sciences. Appointments shall be made not later than 18 months after the date of enactment of the Clean Air Act Amendments of 1990 [“(d) The Administrator of the Environmental Protection Agency and the heads of all other departments, agencies, and instrumentalities of the executive branch of the Federal Government shall, to the maximum extent practicable, assist the Commission in gathering such information as the Commission deems necessary to carry out this section subject to other provisions of law.“(e) “(1) In the conduct of the study required by this section, the Commission is authorized to contract (in accordance with Federal contract law) with nongovernmental entities that are competent to perform research or investigations within the Commission’s mandate, and to hold public hearings, forums, and workshops to enable full public participation.“(2) The Commission may appoint and fix the pay of such staff as it deems necessary in accordance with the provisions of title 5, United States Code. The Commission may request the temporary assignment of personnel from the Environmental Protection Agency or other Federal agencies.“(3) The members of the Commission who are not officers or employees of the United States, while attending conferences or meetings of the Commission or while otherwise serving at the request of the Chair, shall be entitled to receive compensation at a rate not in excess of the maximum rate of pay for Grade GS–18, as provided in the General Schedule under section 5332 of title 5 of the United States Code, including travel time, and while away from their homes or regular places of business they may be allowed travel expenses, including per diem in lieu of subsistence as authorized by law for persons in the Government service employed intermittently.“(f) A report containing the results of all Commission studies and investigations under this section, together with any appropriate legislative recommendations or administrative recommendations, shall be made available to the public for comment not later than 42 months after the date of enactment of the Clean Air Act Amendments of 1990 [“(g) There are authorized to be appropriated such sums as are necessary to carry out the activities of the Commission established by this section.”
[References in laws to the rates of pay for GS–16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, § 101(c)(1)] of Pub. L. 101–509, set out in a note under section 5376 of Title 5.]
Memorandum of President of the United States,
Memorandum for the Administrator of the Environmental Protection Agency
WHEREAS, the Environmental Protection Agency, the agencies and departments that are members of the National Response Team (authorized under Executive Order No. 12580, 52 Fed. Reg. 2923 (1987) [42 U.S.C. 9615 note]), and other Federal agencies and departments undertake emergency release prevention, mitigation, and response activities pursuant to various authorities;
By the authority vested in me as President by the Constitution and the laws of the United States of America, including section 112(r)(10) of the Clean Air Act (the “Act”) (section 7412(r)(10) of title 42 of the United States Code) and section 301 of title 3 of the United States Code, and in order to provide for the delegation of certain functions under the Act [42 U.S.C. 7401 et seq.], I hereby:
(1) Authorize you, in coordination with agencies and departments that are members of the National Response Team and other appropriate agencies and departments, to conduct a review of release prevention, mitigation, and response authorities of Federal agencies in order to assure the most effective and efficient implementation of such authorities and to identify any deficiencies in authority or resources that may exist, to the extent such review is required by section 112(r)(10) of the Act; and
(2) Authorize you, in coordination with agencies and departments that are members of the National Response Team and other appropriate agencies and departments, to prepare and transmit a message to the Congress concerning the release prevention, mitigation, and response activities of the Federal Government with such recommendations for change in law as you deem appropriate, to the extent such message is required by section 112(r)(10) of the Act.
The authority delegated by this memorandum may be further redelegated within the Environmental Protection Agency.
You are hereby authorized and directed to publish this memorandum in the Federal Register.
Memorandum of President of the United States,
Memorandum for the Attorney General[, ] the Administrator of the Environmental Protection Agency[, and] the Director of the Office of Management and Budget
By the authority vested in me as President by the Constitution and laws of the United States of America, including section 112(r)(7)(H) of the Clean Air Act (“Act”) (42 U.S.C. 7412(r)(7)(H)), as added by section 3 of the Chemical Safety Information, Site Security and Fuels Regulatory Relief Act (Public Law 106–40), and section 301 of title 3, United States Code, I hereby delegate to:
(1) the Attorney General the authority vested in the President under section 112(r)(7)(H)(ii)(I)(aa) of the Act to assess the increased risk of terrorist and other criminal activity associated with the posting of off-site consequence analysis information on the Internet;
(2) the Administrator of the Environmental Protection Agency (EPA) the authority vested in the President under section 112(r)(7)(H)(ii)(I)(bb) of the Act to assess the incentives created by public disclosure of off-site consequence analysis information for reduction in the risk of accidental releases; and
(3) the Attorney General and the Administrator of EPA, jointly, the authority vested in the President under section 112(r)(7)(H)(ii)(II) of the Act to promulgate regulations, based on these assessments, governing the distribution of off-site consequence analysis information. These regulations, in proposed and final form, shall be subject to review and approval by the Director of the Office of Management and Budget.
The Administrator of EPA is authorized and directed to publish this memorandum in the Federal Register.
Memorandum of President of the United States,
Memorandum for the Administrator of the Environmental Protection Agency
Today’s issuance, by the Environmental Protection Agency (EPA), of the final Mercury and Air Toxics Standards rule for power plants (the “MATS Rule”) represents a major step forward in my Administration’s efforts to protect public health and the environment.
This rule, issued after careful consideration of public comments, prescribes standards under section 112 of the Clean Air Act to control emissions of mercury and other toxic air pollutants from power plants, which collectively are among the largest sources of such pollution in the United States. The EPA estimates that by substantially reducing emissions of pollutants that contribute to neurological damage, cancer, respiratory illnesses, and other health risks, the MATS Rule will produce major health benefits for millions of Americans—including children, older Americans, and other vulnerable populations. Consistent with Executive Order 13563 (Improving Regulation and Regulatory Review), the estimated benefits of the MATS Rule far exceed the estimated costs.
The MATS Rule can be implemented through the use of demonstrated, existing pollution control technologies. The United States is a global market leader in the design and manufacture of these technologies, and it is anticipated that U.S. firms and workers will provide much of the equipment and labor needed to meet the substantial investments in pollution control that the standards are expected to spur.
These new standards will promote the transition to a cleaner and more efficient U.S. electric power system. This system as a whole is critical infrastructure that plays a key role in the functioning of all facets of the U.S. economy, and maintaining its stability and reliability is of critical importance. It is therefore crucial that implementation of the MATS Rule proceed in a cost-effective manner that ensures electric reliability.
Analyses conducted by the EPA and the Department of Energy (DOE) indicate that the MATS Rule is not anticipated to compromise electric generating resource adequacy in any region of the country. The Clean Air Act offers a number of implementation flexibilities, and the EPA has a long and successful history of using those flexibilities to ensure a smooth transition to cleaner technologies.
The Clean Air Act provides 3 years from the effective date of the MATS Rule for sources to comply with its requirements. In addition, section 112(i)(3)(B) of the Act allows the issuance of a permit granting a source up to one additional year where necessary for the installation of controls. As you stated in the preamble to the MATS Rule, this additional fourth year should be broadly available to sources, consistent with the requirements of the law.
The EPA has concluded that 4 years should generally be sufficient to install the necessary emission control equipment, and DOE has issued analysis consistent with that conclusion. While more time is generally not expected to be needed, the Clean Air Act offers other important flexibilities as well. For example, section 113(a) of the Act provides the EPA with flexibility to bring sources into compliance over the course of an additional year, should unusual circumstances arise that warrant such flexibility.
To address any concerns with respect to electric reliability while assuring MATS’ public health benefits, I direct you to take the following actions:
1. Building on the information and guidance that you have provided to the public, relevant stakeholders, and permitting authorities in the preamble of the MATS Rule, work with State and local permitting authorities to make the additional year for compliance with the MATS Rule provided under section 112(i)(3)(B) of the Clean Air Act broadly available to sources, consistent with law, and to invoke this flexibility expeditiously where justified.
2. Promote early, coordinated, and orderly planning and execution of the measures needed to implement the MATS Rule while maintaining the reliability of the electric power system. Consistent with Executive Order 13563, this process should be designed to “promote predictability and reduce uncertainty,” and should include engagement and coordination with DOE, the Federal Energy Regulatory Commission, State utility regulators, Regional Transmission Organizations, the North American Electric Reliability Corporation and regional electric reliability organizations, other grid planning authorities, electric utilities, and other stakeholders, as appropriate.
3. Make available to the public, including relevant stakeholders, information concerning any anticipated use of authorities: (a) under section 112(i)(3)(B) of the Clean Air Act in the event that additional time to comply with the MATS Rule is necessary for the installation of technology; and (b) under section 113(a) of the Clean Air Act in the event that additional time to comply with the MATS Rule is necessary to address a specific and documented electric reliability issue. This information should describe the process for working with entities with relevant expertise to identify circumstances where electric reliability concerns might justify allowing additional time to comply.
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.
You are hereby authorized and directed to publish this memorandum in the Federal Register.
Memorandum of President of the United States,
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:
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 [42 U.S.C. 7412], 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, 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:
(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;
(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) [sic] 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
(iii) inform the Chairman of CEQ when installation of such technology is complete.
(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.