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DEVICE EXEMPTIONS FROM EPA BAN ON OZONE-DEPLETING PRODUCTS

This article was originally published in The Gray Sheet

Executive Summary

DEVICE EXEMPTIONS FROM EPA BAN ON OZONE-DEPLETING PRODUCTS will be revised in an upcoming regulation, FDAers say. FDA is considering expanding its list of "essential" products using chlorofluorocarbons that will be exempted from the Environmental Protection Agency's ban on substances that deplete the ozone layer; EPA's ban was established under the Clean Air Act Amendments of 1990 and takes effect for medical products in January. Currently, such "essential" products include certain metered-dose inhalers, contraceptive vaginal foams, intrarectal hydrocortisone acetate, and certain anesthetic drugs for topical use. By the end of the year, FDA hopes to publish a Federal Register notice requesting information from manufacturers on products that may meet the criteria for exemption from the EPA ban. To be exempted under EPA's provision for "medical devices," EPA regs state that devices, diagnostic products, drugs and drug delivery systems using class I or class II ozone-depleting substances must be listed in FDA regs as "essential" and utilize "a class I or class II substance for which no safe and effective alternative has been developed." Under the provisions of the Clean Air Act, nonessential products containing or manufactured with class 11 ozone-depleting substances would be banned from sale and distribution in interstate commerce beginning Jan. 1. The ban on class I medical products starts Jan. 17. Class I substances, which are considered the most harmful to the ozone layer, include chlorofluorocarbons (CFCs), halons, carbon tetrachloride and methyl chloroform; class 11 substances consist exclusively of hydrofluorocarbons (HCFCs). EPA published a proposed rule in the Sept. 27 Federal Register "to clarify definitions and provide exemptions" from the statutory ban on class 11 ozone-depleting substances. EPA had published a final rule on the ban for class I nonessential products in January as mandated by the Clean Air Act; EPA was not required by statute to promulgate regs on the class II ban. U.S. Surgical recently petitioned FDA to include its powered surgical instrument product line, which makes use of HCFCs as propellants, on the agency's list of "essential" CFC-containing products. USSC argues that if the instruments, including the Endo GIA-60 and PLDS devices, were banned under EPA regs, "surgical techniques relying on these instruments will no longer be possible," which would "have an negative impact on the quality and cost of patient treatment and care." USSC also notes that it currently is working to "find ozone-safe alternatives [to HCFCS] which are also safe in the operating room environment," but to date, has not found any. Under a separate provision of the Clean Air Act, EPA requires warning statements on all products containing or manufactured with class I substances on or after May 15, 1993. FDA recently proposed alternative labeling language that would caution users against discontinuing use of a product without first consulting with their physicians ("The Gray Sheet" July 5, p. 9).
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