42 U.S.C. § 7412
Hazardous air pollutants
The term “major source” means any stationary source or group of stationary sources located within a contiguous area and under common control that emits or has the potential to emit considering controls, in the aggregate, 10 tons per year or more of any hazardous air pollutant or 25 tons per year or more of any combination of hazardous air pollutants. The Administrator may establish a lesser quantity, or in the case of radionuclides different criteria, for a major source than that specified in the previous sentence, on the basis of the potency of the air pollutant, persistence, potential for bioaccumulation, other characteristics of the air pollutant, or other relevant factors.
The term “area source” means any stationary source of hazardous air pollutants that is not a major source. For purposes of this section, the term “area source” shall not include motor vehicles or nonroad vehicles subject to regulation under subchapter II.
The term “stationary source” shall have the same meaning as such term has under section 7411(a) of this title.
The term “new source” means a stationary source the construction or reconstruction of which is commenced after the Administrator first proposes regulations under this section establishing an emission standard applicable to such source.
The term “modification” means any physical change in, or change in the method of operation of, a major source which increases the actual emissions of any hazardous air pollutant emitted by such source by more than a de minimis amount or which results in the emission of any hazardous air pollutant not previously emitted by more than a de minimis amount.
The term “hazardous air pollutant” means any air pollutant listed pursuant to subsection (b).
The term “adverse environmental effect” means any significant and widespread adverse effect, which may reasonably be anticipated, to wildlife, aquatic life, or other natural resources, including adverse impacts on populations of endangered or threatened species or significant degradation of environmental quality over broad areas.
The term “electric utility steam generating unit” means any fossil fuel fired combustion unit of more than 25 megawatts that serves a generator that produces electricity for sale. A unit that cogenerates steam and electricity and supplies more than one-third of its potential electric output capacity and more than 25 megawatts electrical output to any utility power distribution system for sale shall be considered an electric utility steam generating unit.
The term “owner or operator” means any person who owns, leases, operates, controls, or supervises a stationary source.
The term “existing source” means any stationary source other than a new source.
Unless revised, the term “carcinogenic effect” shall have the meaning provided by the Administrator under Guidelines for Carcinogenic Risk Assessment as of the date of enactment.1
The Congress establishes for purposes of this section a list of hazardous air pollutants as follows:
CAS number | Chemical name |
|---|---|
NOTE: For all listings above which contain the word “compounds” and for glycol ethers, the following applies: Unless otherwise specified, these listings are defined as including any unique chemical substance that contains the named chemical (i.e., antimony, arsenic, etc.) as part of that chemical’s infrastructure. | |
1 X′CN where X = H′ or any other group where a formal dissociation may occur. For example KCN or Ca(CN)2. | |
2 Includes mono- and di- ethers of ethylene glycol, diethylene glycol, and triethylene glycol R–(OCH2CH2)n–OR′ where | |
R′ = R, H, or groups which, when removed, yield glycol ethers with the structure: R–(OCH2CH)n–OH. Polymers are excluded from the glycol category. | |
3 Includes mineral fiber emissions from facilities manufacturing or processing glass, rock, or slag fibers (or other mineral derived fibers) of average diameter 1 micrometer or less. | |
4 Includes organic compounds with more than one benzene ring, and which have a boiling point greater than or equal to 100°C. | |
5 A type of atom which spontaneously undergoes radioactive decay. | |
75070 | Acetaldehyde |
60355 | Acetamide |
75058 | Acetonitrile |
98862 | Acetophenone |
53963 | 2-Acetylaminofluorene |
107028 | Acrolein |
79061 | Acrylamide |
79107 | Acrylic acid |
107131 | Acrylonitrile |
107051 | Allyl chloride |
92671 | 4-Aminobiphenyl |
62533 | Aniline |
90040 | o-Anisidine |
1332214 | Asbestos |
71432 | Benzene (including benzene from gasoline) |
92875 | Benzidine |
98077 | Benzotrichloride |
100447 | Benzyl chloride |
92524 | Biphenyl |
117817 | Bis(2-ethylhexyl)phthalate (DEHP) |
542881 | Bis(chloromethyl)ether |
75252 | Bromoform |
106990 | 1,3-Butadiene |
156627 | Calcium cyanamide |
105602 | Caprolactam |
133062 | Captan |
63252 | Carbaryl |
75150 | Carbon disulfide |
56235 | Carbon tetrachloride |
463581 | Carbonyl sulfide |
120809 | Catechol |
133904 | Chloramben |
57749 | Chlordane |
7782505 | Chlorine |
79118 | Chloroacetic acid |
532274 | 2-Chloroacetophenone |
108907 | Chlorobenzene |
510156 | Chlorobenzilate |
67663 | Chloroform |
107302 | Chloromethyl methyl ether |
126998 | Chloroprene |
1319773 | Cresols/Cresylic acid (isomers and mixture) |
95487 | o-Cresol |
108394 | m-Cresol |
106445 | p-Cresol |
98828 | Cumene |
94757 | 2,4-D, salts and esters |
3547044 | DDE |
334883 | Diazomethane |
132649 | Dibenzofurans |
96128 | 1,2-Dibromo-3-chloropropane |
84742 | Dibutylphthalate |
106467 | 1,4-Dichlorobenzene(p) |
91941 | 3,3-Dichlorobenzidene |
111444 | Dichloroethyl ether (Bis(2-chloroethyl)ether) |
542756 | 1,3-Dichloropropene |
62737 | Dichlorvos |
111422 | Diethanolamine |
121697 | N,N-Diethyl aniline (N,N-Dimethylaniline) |
64675 | Diethyl sulfate |
119904 | 3,3-Dimethoxybenzidine |
60117 | Dimethyl aminoazobenzene |
119937 | 3,3′-Dimethyl benzidine |
79447 | Dimethyl carbamoyl chloride |
68122 | Dimethyl formamide |
57147 | 1,1-Dimethyl hydrazine |
131113 | Dimethyl phthalate |
77781 | Dimethyl sulfate |
534521 | 4,6-Dinitro-o-cresol, and salts |
51285 | 2,4-Dinitrophenol |
121142 | 2,4-Dinitrotoluene |
123911 | 1,4-Dioxane (1,4-Diethyleneoxide) |
122667 | 1,2-Diphenylhydrazine |
106898 | Epichlorohydrin (l-Chloro-2,3-epoxypropane) |
106887 | 1,2-Epoxybutane |
140885 | Ethyl acrylate |
100414 | Ethyl benzene |
51796 | Ethyl carbamate (Urethane) |
75003 | Ethyl chloride (Chloroethane) |
106934 | Ethylene dibromide (Dibromoethane) |
107062 | Ethylene dichloride (1,2-Dichloroethane) |
107211 | Ethylene glycol |
151564 | Ethylene imine (Aziridine) |
75218 | Ethylene oxide |
96457 | Ethylene thiourea |
75343 | Ethylidene dichloride (1,1-Dichloroethane) |
50000 | Formaldehyde |
76448 | Heptachlor |
118741 | Hexachlorobenzene |
87683 | Hexachlorobutadiene |
77474 | Hexachlorocyclopentadiene |
67721 | Hexachloroethane |
822060 | Hexamethylene-1,6-diisocyanate |
680319 | Hexamethylphosphoramide |
110543 | Hexane |
302012 | Hydrazine |
7647010 | Hydrochloric acid |
7664393 | Hydrogen fluoride (Hydrofluoric acid) |
123319 | Hydroquinone |
78591 | Isophorone |
58899 | Lindane (all isomers) |
108316 | Maleic anhydride |
67561 | Methanol |
72435 | Methoxychlor |
74839 | Methyl bromide (Bromomethane) |
74873 | Methyl chloride (Chloromethane) |
71556 | Methyl chloroform (1,1,1-Trichloroethane) |
78933 | Methyl ethyl ketone (2-Butanone) |
60344 | Methyl hydrazine |
74884 | Methyl iodide (Iodomethane) |
108101 | Methyl isobutyl ketone (Hexone) |
624839 | Methyl isocyanate |
80626 | Methyl methacrylate |
1634044 | Methyl tert butyl ether |
101144 | 4,4-Methylene bis(2-chloroaniline) |
75092 | Methylene chloride (Dichloromethane) |
101688 | Methylene diphenyl diisocyanate (MDI) |
101779 | 4,4′-Methylenedianiline |
91203 | Naphthalene |
98953 | Nitrobenzene |
92933 | 4-Nitrobiphenyl |
100027 | 4-Nitrophenol |
79469 | 2-Nitropropane |
684935 | N-Nitroso-N-methylurea |
62759 | N-Nitrosodimethylamine |
59892 | N-Nitrosomorpholine |
56382 | Parathion |
82688 | Pentachloronitrobenzene (Quintobenzene) |
87865 | Pentachlorophenol |
108952 | Phenol |
106503 | p-Phenylenediamine |
75445 | Phosgene |
7803512 | Phosphine |
7723140 | Phosphorus |
85449 | Phthalic anhydride |
1336363 | Polychlorinated biphenyls (Aroclors) |
1120714 | 1,3-Propane sultone |
57578 | beta-Propiolactone |
123386 | Propionaldehyde |
114261 | Propoxur (Baygon) |
78875 | Propylene dichloride (1,2-Dichloropropane) |
75569 | Propylene oxide |
75558 | 1,2-Propylenimine (2-Methyl aziridine) |
91225 | Quinoline |
106514 | Quinone |
100425 | Styrene |
96093 | Styrene oxide |
1746016 | 2,3,7,8-Tetrachlorodibenzo-p-dioxin |
79345 | 1,1,2,2-Tetrachloroethane |
127184 | Tetrachloroethylene (Perchloroethylene) |
7550450 | Titanium tetrachloride |
108883 | Toluene |
95807 | 2,4-Toluene diamine |
584849 | 2,4-Toluene diisocyanate |
95534 | o-Toluidine |
8001352 | Toxaphene (chlorinated camphene) |
120821 | 1,2,4-Trichlorobenzene |
79005 | 1,1,2-Trichloroethane |
79016 | Trichloroethylene |
95954 | 2,4,5-Trichlorophenol |
88062 | 2,4,6-Trichlorophenol |
121448 | Triethylamine |
1582098 | Trifluralin |
540841 | 2,2,4-Trimethylpentane |
108054 | Vinyl acetate |
593602 | Vinyl bromide |
75014 | Vinyl chloride |
75354 | Vinylidene chloride (1,1-Dichloroethylene) |
1330207 | Xylenes (isomers and mixture) |
95476 | o-Xylenes |
108383 | m-Xylenes |
106423 | p-Xylenes |
0 | Antimony Compounds |
0 | Arsenic Compounds (inorganic including arsine) |
0 | Beryllium Compounds |
0 | Cadmium Compounds |
0 | Chromium Compounds |
0 | Cobalt Compounds |
0 | Coke Oven Emissions |
0 | Cyanide Compounds 1 |
0 | Glycol ethers 2 |
0 | Lead Compounds |
0 | Manganese Compounds |
0 | Mercury Compounds |
0 | Fine mineral fibers 3 |
0 | Nickel Compounds |
0 | Polycylic Organic Matter 4 |
0 | Radionuclides (including radon) 5 |
0 | Selenium Compounds |
The Administrator shall periodically review the list established by this subsection and publish the results thereof and, where appropriate, revise such list by rule, adding pollutants which present, or may present, through inhalation or other routes of exposure, a threat of adverse human health effects (including, but not limited to, substances which are known to be, or may reasonably be anticipated to be, carcinogenic, mutagenic, teratogenic, neurotoxic, which cause reproductive dysfunction, or which are acutely or chronically toxic) or adverse environmental effects whether through ambient concentrations, bioaccumulation, deposition, or otherwise, but not including releases subject to regulation under subsection (r) as a result of emissions to the air. No air pollutant which is listed under section 7408(a) of this title may be added to the list under this section, except that the prohibition of this sentence shall not apply to any pollutant which independently meets the listing criteria of this paragraph and is a precursor to a pollutant which is listed under section 7408(a) of this title or to any pollutant which is in a class of pollutants listed under such section. No substance, practice, process or activity regulated under subchapter VI of this chapter shall be subject to regulation under this section solely due to its adverse effects on the environment.
If the Administrator determines that information on the health or environmental effects of a substance is not sufficient to make a determination required by this subsection, the Administrator may use any authority available to the Administrator to acquire such information.
The Administrator may establish, by rule, test measures and other analytic procedures for monitoring and measuring emissions, ambient concentrations, deposition, and bioaccumulation of hazardous air pollutants.
The provisions of part C (prevention of significant deterioration) shall not apply to pollutants listed under this section.
The Administrator may not list elemental lead as a hazardous air pollutant under this subsection.
Not later than 12 months after
For the categories and subcategories the Administrator lists, the Administrator shall establish emissions standards under subsection (d), according to the schedule in this subsection and subsection (e).
The Administrator shall list under this subsection each category or subcategory of area sources which the Administrator finds presents a threat of adverse effects to human health or the environment (by such sources individually or in the aggregate) warranting regulation under this section. The Administrator shall, not later than 5 years after
The Administrator may, in the Administrator’s discretion, list any category or subcategory of sources previously regulated under this section as in effect before
In addition to those categories and subcategories of sources listed for regulation pursuant to paragraphs (1) and (3), the Administrator may at any time list additional categories and subcategories of sources of hazardous air pollutants according to the same criteria for listing applicable under such paragraphs. In the case of source categories and subcategories listed after publication of the initial list required under paragraph (1) or (3), emission standards under subsection (d) for the category or subcategory shall be promulgated within 10 years after
With respect to alkylated lead compounds, polycyclic organic matter, hexachlorobenzene, mercury, polychlorinated biphenyls, 2,3,7,8-tetrachlorodibenzofurans and 2,3,7,8-tetrachlorodibenzo-p-dioxin, the Administrator shall, not later than 5 years after
The Administrator shall establish a separate category covering research or laboratory facilities, as necessary to assure the equitable treatment of such facilities. For purposes of this section, “research or laboratory facility” means any stationary source whose primary purpose is to conduct research and development into new processes and products, where such source is operated under the close supervision of technically trained personnel and is not engaged in the manufacture of products for commercial sale in commerce, except in a de minimis manner.
When establishing emissions standards for styrene, the Administrator shall list boat manufacturing as a separate subcategory unless the Administrator finds that such listing would be inconsistent with the goals and requirements of this chapter.
The Administrator shall promulgate regulations establishing emission standards for each category or subcategory of major sources and area sources of hazardous air pollutants listed for regulation pursuant to subsection (c) in accordance with the schedules provided in subsections (c) and (e). The Administrator may distinguish among classes, types, and sizes of sources within a category or subcategory in establishing such standards except that, there shall be no delay in the compliance date for any standard applicable to any source under subsection (i) as the result of the authority provided by this sentence.
With respect to pollutants for which a health threshold has been established, the Administrator may consider such threshold level, with an ample margin of safety, when establishing emission standards under this subsection.
With respect only to categories and subcategories of area sources listed pursuant to subsection (c), the Administrator may, in lieu of the authorities provided in paragraph (2) and subsection (f), elect to promulgate standards or requirements applicable to sources in such categories or subcategories which provide for the use of generally available control technologies or management practices by such sources to reduce emissions of hazardous air pollutants.
The Administrator shall review, and revise as necessary (taking into account developments in practices, processes, and control technologies), emission standards promulgated under this section no less often than every 8 years.
No emission standard or other requirement promulgated under this section shall be interpreted, construed or applied to diminish or replace the requirements of a more stringent emission limitation or other applicable requirement established pursuant to section 7411 of this title, part C or D, or other authority of this chapter or a standard issued under State authority.
No standard for radionuclide emissions from any category or subcategory of facilities licensed by the Nuclear Regulatory Commission (or an Agreement State) is required to be promulgated under this section if the Administrator determines, by rule, and after consultation with the Nuclear Regulatory Commission, that the regulatory program established by the Nuclear Regulatory Commission pursuant to the Atomic Energy Act [42 U.S.C. 2011 et seq.] for such category or subcategory provides an ample margin of safety to protect the public health. Nothing in this subsection shall preclude or deny the right of any State or political subdivision thereof to adopt or enforce any standard or limitation respecting emissions of radionuclides which is more stringent than the standard or limitation in effect under section 7411 of this title or this section.
Emission standards or other regulations promulgated under this subsection shall be effective upon promulgation.
Not later than 24 months after
Notwithstanding section 7607 of this title, no action of the Administrator adding a pollutant to the list under subsection (b) or listing a source category or subcategory under subsection (c) shall be a final agency action subject to judicial review, except that any such action may be reviewed under such section 7607 of this title when the Administrator issues emission standards for such pollutant or category.
The Administrator shall promulgate standards pursuant to subsection (d) applicable to publicly owned treatment works (as defined in title II of the Federal Water Pollution Control Act [33 U.S.C. 1281 et seq.]) not later than 5 years after
Any emission standard established pursuant to this subsection shall become effective upon promulgation.
The Administrator shall not be required to conduct any review under this subsection or promulgate emission limitations under this subsection for any category or subcategory of area sources that is listed pursuant to subsection (c)(3) and for which an emission standard is promulgated pursuant to subsection (d)(5).
In establishing standards for the control of unique chemical substances of listed pollutants without CAS numbers under this subsection, the Administrator shall establish such standards with respect to the health and environmental effects of the substances actually emitted by sources and direct transformation byproducts of such emissions in the categories and subcategories.
The Administrator (or the State) shall establish reasonable procedures for assuring that the requirements applying to modifications under this section are reflected in the permit.
For purposes of this section, if it is not feasible in the judgment of the Administrator to prescribe or enforce an emission standard for control of a hazardous air pollutant or pollutants, the Administrator may, in lieu thereof, promulgate a design, equipment, work practice, or operational standard, or combination thereof, which in the Administrator’s judgment is consistent with the provisions of subsection (d) or (f). In the event the Administrator promulgates a design or equipment standard under this subsection, the Administrator shall include as part of such standard such requirements as will assure the proper operation and maintenance of any such element of design or equipment.
If after notice and opportunity for comment, the owner or operator of any source establishes to the satisfaction of the Administrator that an alternative means of emission limitation will achieve a reduction in emissions of any air pollutant at least equivalent to the reduction in emissions of such pollutant achieved under the requirements of paragraph (1), the Administrator shall permit the use of such alternative by the source for purposes of compliance with this section with respect to such pollutant.
Any standard promulgated under paragraph (1) shall be promulgated in terms of an emission standard whenever it is feasible to promulgate and enforce a standard in such terms.
After the effective date of any emission standard, limitation, or regulation under subsection (d), (f) or (h), no person may construct any new major source or reconstruct any existing major source subject to such emission standard, regulation or limitation unless the Administrator (or a State with a permit program approved under subchapter V) determines that such source, if properly constructed, reconstructed and operated, will comply with the standard, regulation or limitation.
The President may exempt any stationary source from compliance with any standard or limitation under this section for a period of not more than 2 years if the President determines that the technology to implement such standard is not available and that it is in the national security interests of the United States to do so. An exemption under this paragraph may be extended for 1 or more additional periods, each period not to exceed 2 years. The President shall report to Congress with respect to each exemption (or extension thereof) made under this paragraph.
A source for which construction or reconstruction is commenced after the date an emission standard applicable to such source is proposed pursuant to subsection (d) but before the date an emission standard applicable to such source is proposed pursuant to subsection (f) shall not be required to comply with the emission standard under subsection (f) until the date 10 years after the date construction or reconstruction is commenced.
The requirements of this subsection shall apply in each State beginning on the effective date of a permit program established pursuant to subchapter V in such State, but not prior to the date 42 months after
In the event that the Administrator fails to promulgate a standard for a category or subcategory of major sources by the date established pursuant to subsection (e)(1) and (3), and beginning 18 months after such date (but not prior to the effective date of a permit program under subchapter V), the owner or operator of any major source in such category or subcategory shall submit a permit application under paragraph (3) and such owner or operator shall also comply with paragraphs (5) and (6).
By the date established by paragraph (2), the owner or operator of a major source subject to this subsection shall file an application for a permit. If the owner or operator of a source has submitted a timely and complete application for a permit required by this subsection, any failure to have a permit shall not be a violation of paragraph (2), unless the delay in final action is due to the failure of the applicant to timely submit information required or requested to process the application. The Administrator shall not later than 18 months after
Permit applications submitted under this subsection shall be reviewed and approved or disapproved according to the provisions of section 7661d of this title. In the event that the Administrator (or the State) disapproves a permit application submitted under this subsection or determines that the application is incomplete, the applicant shall have up to 6 months to revise the application to meet the objections of the Administrator (or the State).
The permit shall be issued pursuant to subchapter V and shall contain emission limitations for the hazardous air pollutants subject to regulation under this section and emitted by the source that the Administrator (or the State) determines, on a case-by-case basis, to be equivalent to the limitation that would apply to such source if an emission standard had been promulgated in a timely manner under subsection (d). In the alternative, if the applicable criteria are met, the permit may contain an emissions limitation established according to the provisions of subsection (i)(5). For purposes of the preceding sentence, the reduction required by subsection (i)(5)(A) shall be achieved by the date on which the relevant standard should have been promulgated under subsection (d). No such pollutant may be emitted in amounts exceeding an emission limitation contained in a permit immediately for new sources and, as expeditiously as practicable, but not later than the date 3 years after the permit is issued for existing sources or such other compliance date as would apply under subsection (i).
If the Administrator promulgates an emission standard that is applicable to the major source prior to the date on which a permit application is approved, the emission limitation in the permit shall reflect the promulgated standard rather than the emission limitation determined pursuant to paragraph (5), provided that the source shall have the compliance period provided under subsection (i). If the Administrator promulgates a standard under subsection (d) that would be applicable to the source in lieu of the emission limitation established by permit under this subsection after the date on which the permit has been issued, the Administrator (or the State) shall revise such permit upon the next renewal to reflect the standard promulgated by the Administrator providing such source a reasonable time to comply, but no longer than 8 years after such standard is promulgated or 8 years after the date on which the source is first required to comply with the emissions limitation established by paragraph (5), whichever is earlier.
The Congress finds that emissions of hazardous air pollutants from area sources may individually, or in the aggregate, present significant risks to public health in urban areas. Considering the large number of persons exposed and the risks of carcinogenic and other adverse health effects from hazardous air pollutants, ambient concentrations characteristic of large urban areas should be reduced to levels substantially below those currently experienced. It is the purpose of this subsection to achieve a substantial reduction in emissions of hazardous air pollutants from area sources and an equivalent reduction in the public health risks associated with such sources including a reduction of not less than 75 per centum in the incidence of cancer attributable to emissions from such sources.
In addition to the national urban air toxics strategy authorized by paragraph (3), the Administrator shall also encourage and support areawide strategies developed by State or local air pollution control agencies that are intended to reduce risks from emissions by area sources within a particular urban area. From the funds available for grants under this section, the Administrator shall set aside not less than 10 per centum to support areawide strategies addressing hazardous air pollutants emitted by area sources and shall award such funds on a demonstration basis to those States with innovative and effective strategies. At the request of State or local air pollution control officials, the Administrator shall prepare guidelines for control technologies or management practices which may be applicable to various categories or subcategories of area sources.
The Administrator shall report to the Congress at intervals not later than 8 and 12 years after
Each State may develop and submit to the Administrator for approval a program for the implementation and enforcement (including a review of enforcement delegations previously granted) of emission standards and other requirements for air pollutants subject to this section or requirements for the prevention and mitigation of accidental releases pursuant to subsection (r). A program submitted by a State under this subsection may provide for partial or complete delegation of the Administrator’s authorities and responsibilities to implement and enforce emissions standards and prevention requirements but shall not include authority to set standards less stringent than those promulgated by the Administrator under this chapter.
Not later than 12 months after
The Administrator shall establish and maintain an air toxics clearinghouse and center to provide technical information and assistance to State and local agencies and, on a cost recovery basis, to others on control technology, health and ecological risk assessment, risk analysis, ambient monitoring and modeling, and emissions measurement and monitoring. The Administrator shall use the authority of section 7403 of this title to examine methods for preventing, measuring, and controlling emissions and evaluating associated health and ecological risks. Where appropriate, such activity shall be conducted with not-for-profit organizations. The Administrator may conduct research on methods for preventing, measuring and controlling emissions and evaluating associated health and environment risks. All information collected under this paragraph shall be available to the public.
Upon application of a State, the Administrator may make grants, subject to such terms and conditions as the Administrator deems appropriate, to such State for the purpose of assisting the State in developing and implementing a program for submittal and approval under this subsection. Programs assisted under this paragraph may include program elements addressing air pollutants or extremely hazardous substances other than those specifically subject to this section. Grants under this paragraph may include support for high-risk point source review as provided in paragraph (2) and support for the development and implementation of areawide area source programs pursuant to subsection (k).
Whenever the Administrator determines, after public hearing, that a State is not administering and enforcing a program approved pursuant to this subsection in accordance with the guidance published pursuant to paragraph (2) or the requirements of paragraph (5), the Administrator shall so notify the State and, if action which will assure prompt compliance is not taken within 90 days, the Administrator shall withdraw approval of the program. The Administrator shall not withdraw approval of any program unless the State shall have been notified and the reasons for withdrawal shall have been stated in writing and made public.
Nothing in this subsection shall prohibit the Administrator from enforcing any applicable emission standard or requirement under this section.
The Administrator may, after notice and opportunity for public comment, approve a program developed and submitted by a local air pollution control agency (after consultation with the State) pursuant to this subsection and any such agency implementing an approved program may take any action authorized to be taken by a State under this section.
Nothing in this subsection shall affect the authorities and obligations of the Administrator or the State under subchapter V.
The Administrator shall establish at the Chesapeake Bay and Lake Champlain atmospheric deposition stations to monitor deposition of hazardous air pollutants (and in the Administrator’s discretion, other air pollutants) within the Chesapeake Bay and Lake Champlain watersheds. The Administrator shall determine the role of air deposition in the pollutant loadings of the Chesapeake Bay and Lake Champlain, investigate the sources of air pollutants deposited in the watersheds, evaluate the health and environmental effects of such pollutant loadings, and shall sample such pollutants in biota, fish and wildlife within the watersheds, as necessary to characterize such effects.
The Administrator shall design and deploy atmospheric deposition monitoring networks for coastal waters and their watersheds and shall make any information collected through such networks available to the public. As part of this effort, the Administrator shall conduct research to develop and improve deposition monitoring methods, and to determine the relative contribution of atmospheric pollutants to pollutant loadings. For purposes of this subsection, “coastal waters” shall mean estuaries selected pursuant to section 320(a)(2)(A) of the Federal Water Pollution Control Act [33 U.S.C. 1330(a)(2)(A)] or listed pursuant to section 320(a)(2)(B) of such Act [33 U.S.C. 1330(a)(2)(B)] or estuarine research reserves designated pursuant to section 1461 of title 16.
As part of the report to Congress, the Administrator shall determine whether the other provisions of this section are adequate to prevent serious adverse effects to public health and serious or widespread environmental effects, including such effects resulting from indirect exposure pathways, associated with atmospheric deposition to the Great Lakes, the Chesapeake Bay, Lake Champlain and coastal waters of hazardous air pollutants (and their atmospheric transformation products). The Administrator shall take into consideration the tendency of such pollutants to bioaccumulate. Within 5 years after
The Administrator may conduct, in cooperation with the owners and operators of publicly owned treatment works, studies to characterize emissions of hazardous air pollutants emitted by such facilities, to identify industrial, commercial and residential discharges that contribute to such emissions and to demonstrate control measures for such emissions. When promulgating any standard under this section applicable to publicly owned treatment works, the Administrator may provide for control measures that include pretreatment of discharges causing emissions of hazardous air pollutants and process or product substitutions or limitations that may be effective in reducing such emissions. The Administrator may prescribe uniform sampling, modeling and risk assessment methods for use in implementing this subsection.
The Administrator is directed to assess the hazards to public health and the environment resulting from the emission of hydrogen sulfide associated with the extraction of oil and natural gas resources. To the extent practicable, the assessment shall build upon and not duplicate work conducted for an assessment pursuant to section 8002(m) of the Solid Waste Disposal Act [42 U.S.C. 6982(m)] and shall reflect consultation with the States. The assessment shall include a review of existing State and industry control standards, techniques and enforcement. The Administrator shall report to the Congress within 24 months after
Not later than 2 years after
In the case of any category or subcategory of sources the air emissions of which are regulated under subtitle C of the Solid Waste Disposal Act [42 U.S.C. 6921 et seq.], the Administrator shall take into account any regulations of such emissions which are promulgated under such subtitle and shall, to the maximum extent practicable and consistent with the provisions of this section, ensure that the requirements of such subtitle and this section are consistent.
To the extent practicable, the Academy shall evaluate and report on the methodology for assessing the risk of adverse human health effects other than cancer for which safe thresholds of exposure may not exist, including, but not limited to, inheritable genetic mutations, birth defects, and reproductive dysfunctions.
A report on the results of such review shall be submitted to the Senate Committee on Environment and Public Works, the House Committee on Energy and Commerce, the Risk Assessment and Management Commission established by section 303 of the Clean Air Act Amendments of 1990 and the Administrator not later than 30 months after
The Administrator shall assist the Academy in gathering any information the Academy deems necessary to carry out this subsection. The Administrator may use any authority under this chapter to obtain information from any person, and to require any person to conduct tests, keep and produce records, and make reports respecting research or other activities conducted by such person as necessary to carry out this subsection.
Of the funds authorized to be appropriated to the Administrator by this chapter, such amounts as are required shall be available to carry out this subsection.
The Administrator shall consider, but need not adopt, the recommendations contained in the report of the National Academy of Sciences prepared pursuant to this subsection and the views of the Science Advisory Board, with respect to such report. Prior to the promulgation of any standard under subsection (f), and after notice and opportunity for comment, the Administrator shall publish revised Guidelines for Carcinogenic Risk Assessment or a detailed explanation of the reasons that any recommendations contained in the report of the National Academy of Sciences will not be implemented. The publication of such revised Guidelines shall be a final Agency action for purposes of section 7607 of this title.
The Administrator shall oversee the establishment of a National Urban Air Toxics Research Center, to be located at a university, a hospital, or other facility capable of undertaking and maintaining similar research capabilities in the areas of epidemiology, oncology, toxicology, pulmonary medicine, pathology, and biostatistics. The center shall be known as the Mickey Leland National Urban Air Toxics Research Center. The geographic site of the National Urban Air Toxics Research Center should be further directed to Harris County, Texas, in order to take full advantage of the well developed scientific community presence on-site at the Texas Medical Center as well as the extensive data previously compiled for the comprehensive monitoring system currently in place.
The National Urban Air Toxics Research Center shall be governed by a Board of Directors to be comprised of 9 members, the appointment of which shall be allocated pro rata among the Speaker of the House, the Majority Leader of the Senate and the President. The members of the Board of Directors shall be selected based on their respective academic and professional backgrounds and expertise in matters relating to public health, environmental pollution and industrial hygiene. The duties of the Board of Directors shall be to determine policy and research guidelines, submit views from center sponsors and the public and issue periodic reports of center findings and activities.
The Board of Directors shall be advised by a Scientific Advisory Panel, the 13 members of which shall be appointed by the Board, and to include eminent members of the scientific and medical communities. The Panel membership may include scientists with relevant experience from the National Institute of Environmental Health Sciences, the Center for Disease Control, the Environmental Protection Agency, the National Cancer Institute, and others, and the Panel shall conduct peer review and evaluate research results. The Panel shall assist the Board in developing the research agenda, reviewing proposals and applications, and advise on the awarding of research grants.
The center shall be established and funded with both Federal and private source funds.
Any standard under this section in effect before the date of enactment of the Clean Air Act Amendments of 1990 [
Notwithstanding paragraph (1), no standard shall be established under this section, as amended by the Clean Air Act Amendments of 1990, for radionuclide emissions from (A) elemental phosphorous plants, (B) grate calcination elemental phosphorous plants, (C) phosphogypsum stacks, or (D) any subcategory of the foregoing. This section, as in effect prior to the date of enactment of the Clean Air Act Amendments of 1990 [
Notwithstanding paragraph (1), this section, as in effect prior to the date of enactment of the Clean Air Act Amendments of 1990 [
Notwithstanding paragraph (1), no standard promulgated under this section prior to
It shall be the objective of the regulations and programs authorized under this subsection to prevent the accidental release and to minimize the consequences of any such release of any substance listed pursuant to paragraph (3) or any other extremely hazardous substance. The owners and operators of stationary sources producing, processing, handling or storing such substances have a general duty in the same manner and to the same extent as section 654 of title 29 to identify hazards which may result from such releases using appropriate hazard assessment techniques, to design and maintain a safe facility taking such steps as are necessary to prevent releases, and to minimize the consequences of accidental releases which do occur. For purposes of this paragraph, the provisions of section 7604 of this title shall not be available to any person or otherwise be construed to be applicable to this paragraph. Nothing in this section shall be interpreted, construed, implied or applied to create any liability or basis for suit for compensation for bodily injury or any other injury or property damages to any person which may result from accidental releases of such substances.
The Administrator shall promulgate not later than 24 months after
At the time any substance is listed pursuant to paragraph (3), the Administrator shall establish by rule, a threshold quantity for the substance, taking into account the toxicity, reactivity, volatility, dispersibility, combustibility, or flammability of the substance and the amount of the substance which, as a result of an accidental release, is known to cause or may reasonably be anticipated to cause death, injury or serious adverse effects to human health for which the substance was listed. The Administrator is authorized to establish a greater threshold quantity for, or to exempt entirely, any substance that is a nutrient used in agriculture when held by a farmer.
The Administrator may collect and publish information on accident scenarios and consequences covering a range of possible events for substances listed under paragraph (3). The Administrator shall establish a program of long-term research to develop and disseminate information on methods and techniques for hazard assessment which may be useful in improving and validating the procedures employed in the preparation of hazard assessments under this subsection.
The President shall conduct a review of release prevention, mitigation and response authorities of the various Federal agencies and shall clarify and coordinate agency responsibilities to assure the most effective and efficient implementation of such authorities and to identify any deficiencies in authority or resources which may exist. The President may utilize the resources and solicit the recommendations of the Chemical Safety and Hazard Investigation Board in conducting such review. At the conclusion of such review, but not later than 24 months after
Nothing in this subsection shall preclude, deny or limit any right of a State or political subdivision thereof to adopt or enforce any regulation, requirement, limitation or standard (including any procedural requirement) that is more stringent than a regulation, requirement, limitation or standard in effect under this subsection or that applies to a substance not subject to this subsection.
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),
Pub. L. 106–40, § 3(c),
Pub. L. 106–40, § 4,
Pub. L. 101–549, title III, § 303,
[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.