United States Environmental Protection Agency Air and Radiation Stratospheric Protection Division (6205J) December, 1993 CLASS II NONESSENTIAL PRODUCTS BAN SECTION 610(d) OF THE CLEAN AIR ACT AMENDMENTS OF 1990 Overview The Environmental Protection Agency (EPA) has issued regulations that implement the Congressionally-mandated ban on the sale and distribution of certain aerosol and foam products containing or manufactured with class II substances. Section 610(d) of the Clean Air Act (the Act), as amended, prohibits the sale, distribution, or offer of sale or distribution in interstate commerce, of any aerosol product or other pressurized dispenser which contains a class II substance, and of any plastic foam product which contains or is manufactured with a class II substance, after January 1, 1994. This ban is self-effectuating. Currently, hydrochlorofluorocarbons (HCFCs) are the only substances listed as class II ozone-depleting substances. Partially halogenated HCFCs add less chlorine to the stratosphere than the fully halogenated chlorofluorocarbons (CFCs), which are listed as class I substances. Regulations implementing a ban on the sale and distribution of products containing or manufactured with class I substances were published in the Federal Register on January 15, 1993 (58 FR 4768). A Notice of Proposed Rulemaking (NPRM) to implement the class II ban was published in the Federal Register on September 27, 1993 (58 FR 50463). Interstate Commerce The term "interstate commerce" in section 610(d) refers to the product's entire distribution chain up to and including the point of sale to the ultimate consumer. Both the import of any product for sale or distribution within the United States, or the sale or distribution of any product intended for ultimate export from the United States, are acts of interstate commerce and accordingly, are affected by the class II ban. Aerosols The Act authorizes EPA to grant exceptions from the ban for aerosol products or other pressurized dispensers, where: "the use of the aerosol product or pressurized dispenser is determined by the Administrator to be essential as a result of flammability or worker safety concerns" and "the only available alternative to the use of a class II substance is the use of a class I substance which legally could be substituted for such class II substance." Aerosol products must qualify under both standards. Therefore, products receiving exemptions must have the legal use of a class I substances as the only alternative. These products may have received an exception under the Class I Nonessential Products Ban or methyl chloroform, carbon tetrachloride or halons may be the only alternative. The following products meet the standards set by the statute and are exempted from the ban: -solvent uses of class II substances in lubricants, coatings, or cleaning fluids for electrical or electronic equipment -solvent uses of class II substances in lubricants, coatings, or cleaning fluids used for aircraft maintenance -solvent uses of class II substances in mold release agents -propellant uses of HCFC-22 in mold release agents, where no other alternative is available -solvent and propellant uses of class II substances in lubricants/cleaning sprays used with spinnerettes -solvent uses of class II substances in document preservation sprays -propellant uses of HCFC-22 in document preservation sprays that are used solely on thick books, books with coated or dense paper and tightly bound documents -portable fire extinguishing equipment sold to commercial users, owners of marine vessels or boats, and owners of noncommercial aircraft, where no other alternative is available -wasp and hornet sprays for use near high-tension power lines that contain class II substances for solvent purposes only -cleaning fluids for photographic and electronic equipment sold to commercial users, that contain class II substances for solvent purposes only In cases where a propellant may have additional functions (e.g. sovent/propellant), it will be treated as a propellant. Verification and Public Notice Requirements for Aerosol Products Some the exemptions described above require that the seller verify the identification of the purchaser and only sell the product where no other alternative is available. These requirements are discussed below. The sale and distribution or offer of sale or distribution of aerosol cleaning fluids for electronic and photographic equipment is restricted to commercial users only. This is consistent with the Class I Nonessential Products Ban. Sellers are required to provide public notice and verify that the purchasers are commercial, following procedures similar to those promulgated under the class I ban. In order to purchase these products, commercial users must prove that they are indeed commercial entities by presenting any number of existing documents, such as a local business license number, a state tax exemption number or a government contract number. In addition, a sign must be prominently displayed which includes the language stated in Section 82.68 of the final rule. Portable fire extinguishers may only be sold to commercial users or the owners of marine vessels or aircraft. Purchasers of these products must present the appropriate forms of identification described in Section 82.62(b)(j) or (k). In addition, any person who sells or distributes any portable fire extinguisher containing a class II substance must prominently display a sign where sales of these products occur which includes the language stated in Section 82.68(f), or in cases where the purchaser does not physically come in contact with the point of sale, prior written notification must be provided. Sellers of mold release agents containing a class II substances as a propellant must provide written notification to the purchaser prior to the sale that includes the language in Section 82.68(h) indicating that this product may only be sold where no other alternatives are available. Alternatives include other mold release formulations and not-in-kind substitutes. Wasp and hornet sprays containing a class II substance can only be sold for use near high-tension power lines. Sellers of these products must provide written notification that includes the language in Section 82.68(i), indicating that these products can be sold only for exclusive use near high-tension power lines. In all of the above cases, the seller must have a reasonable basis for believing that the person purchasing the product is not purchasing the product for a prohibited application. Foams Congress exempted two types of foam products from this ban: -foam insulation products -integral-skin, rigid, or semi-rigid foam necessary to meet Federal Motor Vehicle Safety Standards. EPA is defining "insulation" as thermal insulation. EPA is basing its determination of foam products used predominately for thermal insulation capabilities on categories of foam rather than examining each foam product's end use. EPA has determined a list of exempted foam products: -closed-cell rigid polyurethane foam; -closed-cell rigid polystyrene boardstock foam; and -closed-cell rigid phenolic foam. In addition, EPA is exempting: -closed-cell rigid polyethylene foam suitable for use as pipe insulation Automotive Safety Foams In accordance with the statute, regulations promulgated under section 610(d) cannot apply to integral skin, rigid, or semi-rigid foam used to provide motor vehicle safety where no adequate substitute substance is available. The Federal Motor Vehicle Safety Standards are, for the most part, performance standards. The use of particular material is generally not specified. EPA has determined that the use of HCFC-blown foams is not necessary to meet most of the standards. However, while substitute blowing agents for integral skin foams are currently in testing, they are not yet commercially available. Therefore, EPA is exempting integral skin foam used to provide motor vehicle safety until January 1, 1996. Medical Devices The Act exempts medical devices defined in section 601(8). In order to fulfill this requirement, EPA is exempting products identified by the Food and Drug Administration (FDA) as "essential," and listed by FDA in 21 CFR 2.125(e). EPA has consulted with FDA and has been informed that FDA has issued a notice aimed at updating 21 CFR 2.125(e) in accordance with section 610. Grandfathering Products placed into initial inventory by the manufacturer by December 31, 1993, can continue to be sold and distributed, or offered for sale or distribution, in interstate commerce after January 1, 1994. In addition, manufacturers that require federal approval for reformulations of a product (such as registration by EPA's Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)), may continue to sell or distribute, or offer for sale or distribution in interstate commerce until 90 days after receiving federal approval or 45 days after being denied federal approval, unless a new viable application has been submitted. In order to qualify for this exemption, applications to all appropriate federal agencies must be submitted prior to January 1, 1994. Finally, EPA is exempting integral skin foam manufactured with HCFCs that are in inventory prior to January 1, 1996. To continue selling any product manufactured with, or containing, a class II substance after January 1, 1994, the manufacturer or distributor must be able to show, upon request by EPA, that the product was in fact manufactured and thus placed into initial inventory by the appropriate allowable date. Shipping forms, lot numbers, manufacture date stamps, invoices, or the like, may be used to identify the date the product was placed into initial inventory. Additional Information Additional information pertaining to this rulemaking is located in: Air Docket A-93-20 Environmental Protection Agency 401 M Street, SW Washington, D.C. 20460 For further information concerning the class II ban or any regulation related to stratospheric ozone protection, please call the Stratospheric Protection Hotline at (800) 296-1996 or write to: Nonessential Products Ban Program Implementation Branch Stratospheric Protection Division Environmental Protection Agency Mail Code: 6205J 401 M Street, SW Washington, D.C. 20460 For additional information concerning the medical devices exemption, please contact: Office of the Commissioner Office of Policy 5600 Fishers Lane HF-23, Rm. 15-74 Rockville, Maryland 20857 (301) 443-2831