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This article was originally published in The Gray Sheet

Executive Summary

GERMICIDE MANUFACTURERS SEEK SUSPENSION OF FDA REGULATORY ACTION against producers of disinfectants and sterilants. In a March 12 letter to FDA Commissioner David Kessler, the Chemical Specialties Manufacturers Association asserts that "further action with respect to [germicides] should be suspended" until "such time as FDA classifies liquid chemical germicides as devices through rulemaking and addresses the legal and scientific issues raised by the various public comments" on FDA's January 1992 guidance document for germicide 510(k)s. FDA's device center is developing a proposal for classification of germicides; the products are currently regulated as accessories to the devices intended to be disinfected or sterilized. The agency has taken regulatory action against at least two germicide manufacturers -- Metrex and Sporicidin International -- and in January 1992, issued a guidance document outlining requirements for germicide 510(k) premarket notifications ("The Gray Sheet" July 6, 1992, p. 18). A recent FDA action of particular concern to CSMA is the issuance of a letter to roughly 400 manufacturers of liquid chemical germicides requesting submission of labeling and promotional materials. FDA is reviewing the material to determine which products fall under the agency's jurisdiction. The letter also informs germicide manufacturers of their responsibility to register their facilities and list their products with FDA. Calling the letter "unfortunate and premature," CSMA urges that the FDA request for data "be immediately suspended." The association claims that the letter "makes little regulatory sense" and "raises serious legal concerns." CSMA asserts that a "suspension [of the data request] is compelled by the Paperwork Reduction Act, which requires review and approval of such requests by the Office of Management and Budget." On March 16, CSMA sent a letter on the subject to the OMB asking the office to "instruct FDA to withdraw these letters" because they are in violation of the Paperwork Reduction Act. CSMA argues it would be more appropriate if agency efforts "focused upon development of an effective and efficient" memorandum of understanding between FDA and the Environmental Protection Agency, which also has authority over germicides, "and upon public discussion of the real issues at stake." FDA has been working with EPA on an MOU for regulation of the products since mid-1992. CSMA says the MOU should "clarify regulatory responsibilities" of the two agencies. "Neither good sense nor good government can tolerate a situation where first one agency reviews data and labels and then a second does precisely the same thing, with potentially conflicting and inconsistent results." The association continues: "This obviously wastes resources...and further complicates a regulatory situation at the two agencies, both of which are nearly at an impasse given current workloads." The MOU also should "provide for sole EPA jurisdiction until such time as the FDA classifies these products," CSMA proclaims. "Until such an MOU is finalized, it is highly inappropriate for the FDA to impose resource intensive data collection requirements on businesses currently operating under valid EPA registrations." CSMA also notes concerns about the 1992 FDA guidance document. Comments on the guidance "questioned the scientific validity of many of the requirements set forth" in the document and "noted that rulemaking should be conducted on the issues raised regarding the regulation by FDA of liquid chemical germicides historically regulated by EPA, and not, to date, classified by the FDA as devices." CSMA concludes: "FDA would do well to allocate its limited resources to specific classification of those products of concern" and "to provide a public forum for discussion and decision of these issues." In a same-day letter to EPA Administrator Carol Browner, CSMA decries the "dual regulatory track" for germicides "which more than doubles time and effort involved in securing federal product approval." CSMA asks EPA to: establish "a division of responsibility between EPA and FDA as to the products pending completion of an MOU"; "expedite the preparation and completion of a final MOU"; and "assure that there is full public comment in the process."



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