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42 U.S.C. § 7671a — Listing of class I and class II substances

Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 7671a — Listing of class I and class II substances

Page 7449 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 7671a Employees. For complete classification of this Act to the Code, see Short Title note set out under section 601 of Title 5 and Tables. The Equal Access to Justice Act, referred to in sub- secs. (d)(2) and (e)(1)(B), is title II of Pub. L. 96–481, Oct. 21, 1980, 94 Stat. 2325. For complete classification of this Act to the Code, see Short Title note set out under sec- tion 504 of Title 5. SUBCHAPTER VI—STRATOSPHERIC OZONE PROTECTION § 7671. Definitions As used in this subchapter— (1) Appliance The term ‘‘appliance’’ means any device which contains and uses a class I or class II substance as a refrigerant and which is used for household or commercial purposes, includ- ing any air conditioner, refrigerator, chiller, or freezer. (2) Baseline year The term ‘‘baseline year’’ means— (A) the calendar year 1986, in the case of any class I substance listed in Group I or II under section 7671a(a) of this title, (B) the calendar year 1989, in the case of any class I substance listed in Group III, IV, or V under section 7671a(a) of this title, and (C) a representative calendar year selected by the Administrator, in the case of— (i) any substance added to the list of class I substances after the publication of the initial list under section 7671a(a) of this title, and (ii) any class II substance. (3) Class I substance The term ‘‘class I substance’’ means each of the substances listed as provided in section 7671a(a) of this title. (4) Class II substance The term ‘‘class II substance’’ means each of the substances listed as provided in section 7671a(b) of this title. (5) Commissioner The term ‘‘Commissioner’’ means the Com- missioner of the Food and Drug Administra- tion. (6) Consumption The

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Page 7449 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 7671a Employees. For complete classification of this Act to the Code, see Short Title note set out under section 601 of Title 5 and Tables. The Equal Access to Justice Act, referred to in sub- secs. (d)(2) and (e)(1)(B), is title II of Pub. L. 96–481, Oct. 21, 1980, 94 Stat. 2325. For complete classification of this Act to the Code, see Short Title note set out under sec- tion 504 of Title 5. SUBCHAPTER VI—STRATOSPHERIC OZONE PROTECTION § 7671. Definitions As used in this subchapter— (1) Appliance The term ‘‘appliance’’ means any device which contains and uses a class I or class II substance as a refrigerant and which is used for household or commercial purposes, includ- ing any air conditioner, refrigerator, chiller, or freezer. (2) Baseline year The term ‘‘baseline year’’ means— (A) the calendar year 1986, in the case of any class I substance listed in Group I or II under section 7671a(a) of this title, (B) the calendar year 1989, in the case of any class I substance listed in Group III, IV, or V under section 7671a(a) of this title, and (C) a representative calendar year selected by the Administrator, in the case of— (i) any substance added to the list of class I substances after the publication of the initial list under section 7671a(a) of this title, and (ii) any class II substance. (3) Class I substance The term ‘‘class I substance’’ means each of the substances listed as provided in section 7671a(a) of this title. (4) Class II substance The term ‘‘class II substance’’ means each of the substances listed as provided in section 7671a(b) of this title. (5) Commissioner The term ‘‘Commissioner’’ means the Com- missioner of the Food and Drug Administra- tion. (6) Consumption The term ‘‘consumption’’ means, with re- spect to any substance, the amount of that substance produced in the United States, plus the amount imported, minus the amount ex- ported to Parties to the Montreal Protocol. Such term shall be construed in a manner con- sistent with the Montreal Protocol. (7) Import The term ‘‘import’’ means to land on, bring into, or introduce into, or attempt to land on, bring into, or introduce into, any place subject to the jurisdiction of the United States, whether or not such landing, bringing, or in- troduction constitutes an importation within the meaning of the customs laws of the United States. (8) Medical device The term ‘‘medical device’’ means any de- vice (as defined in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)), diagnostic prod- uct, drug (as defined in the Federal Food, Drug, and Cosmetic Act), and drug delivery system— (A) if such device, product, drug, or drug delivery system utilizes a class I or class II substance for which no safe and effective al- ternative has been developed, and where nec- essary, approved by the Commissioner; and (B) if such device, product, drug, or drug delivery system, has, after notice and oppor- tunity for public comment, been approved and determined to be essential by the Com- missioner in consultation with the Adminis- trator. (9) Montreal Protocol The terms ‘‘Montreal Protocol’’ and ‘‘the Protocol’’ mean the Montreal Protocol on Substances that Deplete the Ozone Layer, a protocol to the Vienna Convention for the Protection of the Ozone Layer, including ad- justments adopted by Parties thereto and amendments that have entered into force. (10) Ozone-depletion potential The term ‘‘ozone-depletion potential’’ means a factor established by the Administrator to reflect the ozone-depletion potential of a sub- stance, on a mass per kilogram basis, as com- pared to chlorofluorocarbon-11 (CFC–11). Such factor shall be based upon the substance’s at- mospheric lifetime, the molecular weight of bromine and chlorine, and the substance’s ability to be photolytically disassociated, and upon other factors determined to be an accu- rate measure of relative ozone-depletion po- tential. (11) Produce, produced, and production The terms ‘‘produce’’, ‘‘produced’’, and ‘‘pro- duction’’, refer to the manufacture of a sub- stance from any raw material or feedstock chemical, but such terms do not include— (A) the manufacture of a substance that is used and entirely consumed (except for trace quantities) in the manufacture of other chemicals, or (B) the reuse or recycling of a substance. (July 14, 1955, ch. 360, title VI, § 601, as added Pub. L. 101–549, title VI, § 602(a), Nov. 15, 1990, 104 Stat. 2649.) Editorial Notes REFERENCES IN TEXT The Federal Food, Drug, and Cosmetic Act, referred to in par. (8), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§ 301 et seq.) of Title 21, Food and Drugs. For complete classification of this Act to the Code, see section 301 of Title 21 and Tables. § 7671a. Listing of class I and class II substances (a) List of class I substances Within 60 days after November 15, 1990, the Ad- ministrator shall publish an initial list of class I substances, which list shall contain the fol- lowing substances: Group I chlorofluorocarbon-11 (CFC–11) Page 7450 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 7671a 1 So in original. Probably should be section ‘‘7671f’’. chlorofluorocarbon-12 (CFC–12) chlorofluorocarbon-113 (CFC–113) chlorofluorocarbon-114 (CFC–114) chlorofluorocarbon-115 (CFC–115) Group II halon-1211 halon-1301 halon-2402 Group III chlorofluorocarbon-13 (CFC–13) chlorofluorocarbon-111 (CFC–111) chlorofluorocarbon-112 (CFC–112) chlorofluorocarbon-211 (CFC–211) chlorofluorocarbon-212 (CFC–212) chlorofluorocarbon-213 (CFC–213) chlorofluorocarbon-214 (CFC–214) chlorofluorocarbon-215 (CFC–215) chlorofluorocarbon-216 (CFC–216) chlorofluorocarbon-217 (CFC–217) Group IV carbon tetrachloride Group V methyl chloroform The initial list under this subsection shall also include the isomers of the substances listed above, other than 1,1,2-trichloroethane (an iso- mer of methyl chloroform). Pursuant to sub- section (c), the Administrator shall add to the list of class I substances any other substance that the Administrator finds causes or contrib- utes significantly to harmful effects on the stratospheric ozone layer. The Administrator shall, pursuant to subsection (c), add to such list all substances that the Administrator deter- mines have an ozone depletion potential of 0.2 or greater. (b) List of class II substances Simultaneously with publication of the initial list of class I substances, the Administrator shall publish an initial list of class II sub- stances, which shall contain the following sub- stances: hydrochlorofluorocarbon-21 (HCFC–21) hydrochlorofluorocarbon-22 (HCFC–22) hydrochlorofluorocarbon-31 (HCFC–31) hydrochlorofluorocarbon-121 (HCFC–121) hydrochlorofluorocarbon-122 (HCFC–122) hydrochlorofluorocarbon-123 (HCFC–123) hydrochlorofluorocarbon-124 (HCFC–124) hydrochlorofluorocarbon-131 (HCFC–131) hydrochlorofluorocarbon-132 (HCFC–132) hydrochlorofluorocarbon-133 (HCFC–133) hydrochlorofluorocarbon-141 (HCFC–141) hydrochlorofluorocarbon-142 (HCFC–142) hydrochlorofluorocarbon-221 (HCFC–221) hydrochlorofluorocarbon-222 (HCFC–222) hydrochlorofluorocarbon-223 (HCFC–223) hydrochlorofluorocarbon-224 (HCFC–224) hydrochlorofluorocarbon-225 (HCFC–225) hydrochlorofluorocarbon-226 (HCFC–226) hydrochlorofluorocarbon-231 (HCFC–231) hydrochlorofluorocarbon-232 (HCFC–232) hydrochlorofluorocarbon-233 (HCFC–233) hydrochlorofluorocarbon-234 (HCFC–234) hydrochlorofluorocarbon-235 (HCFC–235) hydrochlorofluorocarbon-241 (HCFC–241) hydrochlorofluorocarbon-242 (HCFC–242) hydrochlorofluorocarbon-243 (HCFC–243) hydrochlorofluorocarbon-244 (HCFC–244) hydrochlorofluorocarbon-251 (HCFC–251) hydrochlorofluorocarbon-252 (HCFC–252) hydrochlorofluorocarbon-253 (HCFC–253) hydrochlorofluorocarbon-261 (HCFC–261) hydrochlorofluorocarbon-262 (HCFC–262) hydrochlorofluorocarbon-271 (HCFC–271) The initial list under this subsection shall also include the isomers of the substances listed above. Pursuant to subsection (c), the Adminis- trator shall add to the list of class II substances any other substance that the Administrator finds is known or may reasonably be anticipated to cause or contribute to harmful effects on the stratospheric ozone layer. (c) Additions to the lists (1) The Administrator may add, by rule, in ac- cordance with the criteria set forth in sub- section (a) or (b), as the case may be, any sub- stance to the list of class I or class II substances under subsection (a) or (b). For purposes of ex- changes under section 7661f 1 of this title, when- ever a substance is added to the list of class I substances the Administrator shall, to the ex- tent consistent with the Montreal Protocol, as- sign such substance to existing Group I, II, III, IV, or V or place such substance in a new Group. (2) Periodically, but not less frequently than every 3 years after November 15, 1990, the Ad- ministrator shall list, by rule, as additional class I or class II substances those substances which the Administrator finds meet the criteria of subsection (a) or (b), as the case may be. (3) At any time, any person may petition the Administrator to add a substance to the list of class I or class II substances. Pursuant to the criteria set forth in subsection (a) or (b) as the case may be, within 180 days after receiving such a petition, the Administrator shall either propose to add the substance to such list or pub- lish an explanation of the petition denial. In any case where the Administrator proposes to add a substance to such list, the Administrator shall add, by rule, (or make a final determination not to add) such substance to such list within 1 year after receiving such petition. Any petition under this paragraph shall include a showing by the petitioner that there are data on the substance adequate to support the petition. If the Admin- istrator determines that information on the sub- stance is not sufficient to make a determination under this paragraph, the Administrator shall use any authority available to the Adminis- trator, under any law administered by the Ad- ministrator, to acquire such information. (4) Only a class II substance which is added to the list of class I substances may be removed from the list of class II substances. No substance referred to in subsection (a), including methyl chloroform, may be removed from the list of class I substances. (d) New listed substances In the case of any substance added to the list of class I or class II substances after publication of the initial list of such substances under this section, the Administrator may extend any schedule or compliance deadline contained in section 7671c or 7671d of this title to a later date than specified in such sections if such schedule or deadline is unattainable, considering when such substance is added to the list. No extension Page 7451 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 7671b under this subsection may extend the date for termination of production of any class I sub- stance to a date more than 7 years after January 1 of the year after the year in which the sub- stance is added to the list of class I substances. No extension under this subsection may extend the date for termination of production of any class II substance to a date more than 10 years after January 1 of the year after the year in which the substance is added to the list of class II substances. (e) Ozone-depletion and global warming poten- tial Simultaneously with publication of the lists under this section and simultaneously with any addition to either of such lists, the Adminis- trator shall assign to each listed substance a nu- merical value representing the substance’s ozone-depletion potential. In addition, the Ad- ministrator shall publish the chlorine and bro- mine loading potential and the atmospheric life- time of each listed substance. One year after No- vember 15, 1990 (one year after the addition of a substance to either of such lists in the case of a substance added after the publication of the ini- tial lists of such substances), and after notice and opportunity for public comment, the Ad- ministrator shall publish the global warming po- tential of each listed substance. The preceding sentence shall not be construed to be the basis of any additional regulation under this chapter. In the case of the substances referred to in table 1, the ozone-depletion potential shall be as spec- ified in table 1, unless the Administrator adjusts the substance’s ozone-depletion potential based on criteria referred to in section 7671(10) of this title: TABLE 1 Substance Ozone- depletion potential chlorofluorocarbon-11 (CFC–11) .................... 1.0 chlorofluorocarbon-12 (CFC–12) .................... 1.0 chlorofluorocarbon-13 (CFC–13) .................... 1.0 chlorofluorocarbon-111 (CFC–111) ................. 1.0 chlorofluorocarbon-112 (CFC–112) ................. 1.0 chlorofluorocarbon-113 (CFC–113) ................. 0.8 chlorofluorocarbon-114 (CFC–114) ................. 1.0 chlorofluorocarbon-115 (CFC–115) ................. 0.6 chlorofluorocarbon-211 (CFC–211) ................. 1.0 chlorofluorocarbon-212 (CFC–212) ................. 1.0 chlorofluorocarbon-213 (CFC–213) ................. 1.0 chlorofluorocarbon-214 (CFC–214) ................. 1.0 chlorofluorocarbon-215 (CFC–215) ................. 1.0 chlorofluorocarbon-216 (CFC–216) ................. 1.0 chlorofluorocarbon-217 (CFC–217) ................. 1.0 halon-1211 ..................................................... 3.0 halon-1301 ..................................................... 10.0 halon-2402 ..................................................... 6.0 carbon tetrachloride .................................... 1.1 methyl chloroform ....................................... 0.1 hydrochlorofluorocarbon-22 (HCFC–22) ........ 0.05 hydrochlorofluorocarbon-123 (HCFC–123) ..... 0.02 hydrochlorofluorocarbon-124 (HCFC–124) ..... 0.02 hydrochlorofluorocarbon-141(b) (HCFC–141(b)) ............................................ 0.1 hydrochlorofluorocarbon-142(b) (HCFC–142(b)) ............................................ 0.06 Where the ozone-depletion potential of a sub- stance is specified in the Montreal Protocol, the ozone-depletion potential specified for that sub- stance under this section shall be consistent with the Montreal Protocol. (July 14, 1955, ch. 360, title VI, § 602, as added Pub. L. 101–549, title VI, § 602(a), Nov. 15, 1990, 104 Stat. 2650.) § 7671b. Monitoring and reporting requirements (a) Regulations Within 270 days after November 15, 1990, the Administrator shall amend the regulations of the Administrator in effect on such date regard- ing monitoring and reporting of class I and class II substances. Such amendments shall conform to the requirements of this section. The amend- ed regulations shall include requirements with respect to the time and manner of monitoring and reporting as required under this section. (b) Production, import, and export level reports On a quarterly basis, or such other basis (not less than annually) as determined by the Admin- istrator, each person who produced, imported, or exported a class I or class II substance shall file a report with the Administrator setting forth the amount of the substance that such person produced, imported, and exported during the preceding reporting period. Each such report shall be signed and attested by a responsible of- ficer. No such report shall be required from a person after April 1 of the calendar year after such person permanently ceases production, im- portation, and exportation of the substance and so notifies the Administrator in writing. (c) Baseline reports for class I substances Unless such information has previously been reported to the Administrator, on the date on which the first report under subsection (b) is re- quired to be filed, each person who produced, im- ported, or exported a class I substance (other than a substance added to the list of class I sub- stances after the publication of the initial list of such substances under this section) shall file a report with the Administrator setting forth the amount of such substance that such person pro- duced, imported, and exported during the base- line year. In the case of a substance added to the list of class I substances after publication of the initial list of such substances under this section, the regulations shall require that each person who produced, imported, or exported such sub- stance shall file a report with the Administrator within 180 days after the date on which such substance is added to the list, setting forth the amount of the substance that such person pro- duced, imported, and exported in the baseline year. (d) Monitoring and reports to Congress (1) The Administrator shall monitor and, not less often than every 3 years following Novem- ber 15, 1990, submit a report to Congress on the production, use and consumption of class I and class II substances. Such report shall include data on domestic production, use and consump- tion, and an estimate of worldwide production, use and consumption of such substances. Not less frequently than every 6 years the Adminis- trator shall report to Congress on the environ- mental and economic effects of any strato- spheric ozone depletion.

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 321 — Definitions; generally

For the purposes of this chapter— **(a)** (1) The term “State”, except as used in the last sentence of [section 372(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section372/a&num=0&edition=prelim), means any State or Territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico. (2) The term “Territory” means any Territory or possession of the United States, including the District of Columbia, and excluding the Commonwealth of Puerto Rico and the Canal Zone. **(b)** The term “interstate commerce” means (1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District of Columbia or within any other Territory not organized with a legislative body. **(c)** The term “Department” means Department of Health and Human Services. **(d)** The term “Secretary” means the Secretary of Health and Human Services. **(e)** The term “person” includes individual, partnership, corporation, and association. **(f)** The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article. **(g)** (1) The term “drug” means (A) articles recognized in the official United States Pharmacopoeia,11 So in original. Probably should be “Pharmacopeia,”. official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specif

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 321 — Definitions; generally

Page 36 TITLE 21—FOOD AND DRUGS § 321 1 So in original. Probably should be ‘‘Pharmacopeia,’’. of this title and section 210 of Title 42, The Public Health and Welfare, and enacting provisions set out as notes under sections 321, 342, and 451 of this title] may be cited as the ‘Food Additives Amendment of 1958’.’’ SEVERABILITY Pub. L. 113–54, title I, § 106(b), Nov. 27, 2013, 127 Stat. 598, provided that: ‘‘If any provision of this Act [see Short Title of 2013 Amendment note above] (including the amendments made by this Act) is declared uncon- stitutional, or the applicability of this Act (including the amendments made by this Act) to any person or circumstance is held invalid, the constitutionality of the remainder of this Act (including the amendments made by this Act) and the applicability thereof to other persons and circumstances shall not be affected.’’ Pub. L. 110–85, title XI, § 1105, Sept. 27, 2007, 121 Stat. 975, provided that: ‘‘If any provision of this Act [see Short Title of 2007 Amendment note above], an amend- ment made [by] this Act, or the application of such pro- vision or amendment to any person or circumstance is held to be unconstitutional, the remainder of this Act, the amendments made by this Act, and the application of the provisions of such to any person or cir- cumstances shall not be affected thereby.’’ HAZARDOUS SUBSTANCES Federal Hazardous Substances Act as not modifying this chapter, see Pub. L. 86–613, § 18, July 12, 1960, 74 Stat. 380, set out as an Effect Upon Federal and State Laws note under section 1261 of Title 15, Commerce and Trade. SUBCHAPTER II—DEFINITIONS § 321. Definitions; generally For the purposes of this chapter— (a)(1) The term ‘‘State’’, except as used in the last sentence of section 372(a) of thi

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 7671a — Listing of class I and class II substances

**(a) List of class I substances** Within 60 days after November 15, 1990, the Administrator shall publish an initial list of class I substances, which list shall contain the following substances: Group I chlorofluorocarbon-11 (CFC–11) chlorofluorocarbon-12 (CFC–12) chlorofluorocarbon-113 (CFC–113) chlorofluorocarbon-114 (CFC–114) chlorofluorocarbon-115 (CFC–115) Group II halon-1211 halon-1301 halon-2402 Group III chlorofluorocarbon-13 (CFC–13) chlorofluorocarbon-111 (CFC–111) chlorofluorocarbon-112 (CFC–112) chlorofluorocarbon-211 (CFC–211) chlorofluorocarbon-212 (CFC–212) chlorofluorocarbon-213 (CFC–213) chlorofluorocarbon-214 (CFC–214) chlorofluorocarbon-215 (CFC–215) chlorofluorocarbon-216 (CFC–216) chlorofluorocarbon-217 (CFC–217) Group IV carbon tetrachloride Group V methyl chloroform The initial list under this subsection shall also include the isomers of the substances listed above, other than 1,1,2-trichloroethane (an isomer of methyl chloroform). Pursuant to subsection (c), the Administrator shall add to the list of class I substances any other substance that the Administrator finds causes or contributes significantly to harmful effects on the stratospheric ozone layer. The Administrator shall, pursuant to subsection (c), add to such list all substances that the Administrator determines have an ozone depletion potential of 0.2 or greater. **(b) List of class II substances** Simultaneously with publication of the initial list of class I substances, the Administrator shall publish an initial list of class II substances, which shall contain the following substances: hydrochlorofluorocarbon-21 (HCFC–21) hydrochlorofluorocarbon-22 (HCFC–22) hydrochlorofluorocarbon-31 (HCFC–31) hydrochlorofluorocarbon-121 (HCFC–121) hydrochlorofluorocarbon-122 (HCFC–122) hydrochlor

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