Title 42, The Public Health and WelfareRelease 119-110

§7671 Definitions

Title 42 › CHAPTER 85 — AIR POLLUTION PREVENTION AND CONTROL › SUBCHAPTER VI — STRATOSPHERIC OZONE PROTECTION › § 7671

Last updated Sep 22, 2026|Official source

Summary

Defines key words used in the rules about substances that harm the ozone layer. It gives short explanations for terms you will see later in the law. Appliance is a household or commercial device that uses a class I or class II refrigerant, like air conditioners, refrigerators, chillers, or freezers. Baseline year is 1986 for certain Group I or II class I substances, 1989 for Group III–V class I substances, or a representative year chosen by the Administrator for substances added later and for all class II substances. Class I substance refers to the specific chemicals listed under 7671a(a). Class II substance refers to the specific chemicals listed under 7671a(b). Commissioner means the Commissioner of the Food and Drug Administration. Consumption is the amount produced in the United States plus imports minus exports to Parties to the Montreal Protocol, counted in a way that matches the Montreal Protocol. Import means bringing or trying to bring something into any place under U.S. jurisdiction, even if customs law would not call it an import. Medical device means any device, diagnostic product, drug, or drug delivery system (as defined in the Federal Food, Drug, and Cosmetic Act) that uses a class I or II substance when no safe alternative exists, is approved by the Commissioner when needed, and has been found essential after public notice and comment with the Commissioner consulting the Administrator. Montreal Protocol means the Montreal Protocol on Substances that Deplete the Ozone Layer, a protocol to the Vienna Convention, including adjustments and amendments that have entered into force. Ozone-depletion potential is a factor the Administrator sets that compares a substance’s effect to CFC–11 and is based on atmospheric lifetime, the molecular weight of bromine and chlorine, how easily the substance breaks down in light, and other accurate measures. Produce, produced, and production mean making a substance from raw materials, but do not include making a substance that is all used up in making other chemicals (except tiny leftovers) or reusing or recycling a substance.

Full Legal Text

Title 42, §7671

The Public Health and Welfare, Source: USLM XML via OLRC

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, including 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 Commissioner of the Food and Drug Administration.
(6)Consumption
The term “consumption” means, with respect to any substance, the amount of that substance produced in the United States, plus the amount imported, minus the amount exported to Parties to the Montreal Protocol. Such term shall be construed in a manner consistent 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 introduction constitutes an importation within the meaning of the customs laws of the United States.
(8)Medical device
The term “medical device” means any device (as defined in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)), diagnostic product, 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 alternative has been developed, and where necessary, approved by the Commissioner; and
(B)if such device, product, drug, or drug delivery system, has, after notice and opportunity for public comment, been approved and determined to be essential by the Commissioner in consultation with the Administrator.
(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 adjustments 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 substance, on a mass per kilogram basis, as compared to chlorofluorocarbon-11 (CFC–11). Such factor shall be based upon the substance’s atmospheric 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 accurate measure of relative ozone-depletion potential.
(11)Produce, produced, and production
The terms “produce”, “produced”, and “production”, refer to the manufacture of a substance 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.

Legislative History

Notes & Related Subsidiaries

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.

Reference

Citations & Metadata

Citation

42 U.S.C. § 7671

Title 42, The Public Health and Welfare

Last Updated

Sep 22, 2026

Release point: 119-110