§7671 Definitions

Summary

Defines key words used in the rules about chemicals that hurt the ozone layer. Appliance means a device that uses a class I or II refrigerant for homes or businesses, like air conditioners, refrigerators, chillers, or freezers. Baseline year is 1986 for class I substances in Groups I–II, 1989 for class I substances in Groups III–V, and a representative year picked by the Administrator for any substance added later or for class II substances. Class I substance and Class II substance are the chemicals the law lists as class I or class II. Commissioner means the FDA Commissioner. Consumption means what is made in the U.S. plus what is imported, minus what is exported to Parties to the Montreal Protocol, and is measured to match that treaty. Import means bringing or trying to bring something into the United States or any place under U.S. control. Medical device means a device, diagnostic, drug, or drug-delivery system that uses a class I or II substance when no safe alternative exists and that the FDA Commissioner, after public notice and consultation with the Administrator, approves as essential. Montreal Protocol means the international treaty on substances that deplete the ozone layer, including adjustments and amendments in force. Ozone-depletion potential is a number the Administrator sets to compare how much a substance harms ozone to CFC–11, based on things like how long it lasts in the atmosphere and how it breaks down. Produce/produced/production means making a substance from raw materials, but does not include making a substance that is entirely used up to make other chemicals or the reuse or recycling of a substance.