were received, the FDA evaluated each comment for its merit and how the specific suggested change would meet the Agency's need for ensuring the best possible data. In the pream ble of the final GLP regulations in the December 22,1978, Federal Register, the comments received by the Agency are each discussed with the Commis sioner's reason for accepting or reject ing each suggestion. Many suggestions were accepted. A critical one from the analytical aspect was that the material being safety tested can be "appro priately characterized" rather than identity, strength, quality, and purity being automatically specified. This critical change permits sound scientif ic judgment to be exercised in the characterization of the materials being tested. Because of the Agency, the final GLP's are more manageable, less cost ly, and still.meet the original purpose. Many of the details on exactly how the scientific work is to be conducted have been eliminated, and profession al judgment can replace detailed rules. This final GLP still meets the Agen cy's needs, but does not place an undue burden on the scientists in volved in assessing the safety of new chemicals. The final GLP regulations demonstrate the desire on the part of the Agency to work with those regulat ed to produce meaningful rules. With out this willingness to adopt scientific input, there would have been a manyfold increase in cost of safety testing. More importantly, the number of safe ty tests and the time required to com plete safety work would have de creased the number of new health products made available to the con sumer. The regulatory area continues to change, and there are many similar chances for scientific input to a gov ernmental agency. For example, the Environmental Protection Agency (EPA) will issue in the coming months their version of the GLP's covering safety studies for the materials they regulate. To avoid considerable confu sion, it is imperative that the EPA's rules be consistent with final GLP's from the FDA. Those to be regulated should carefully examine the EPA's proposed GLP rules and provide the EPA with written comments on unac ceptable aspects. Table I lists regula tory proposals or anticipated propos als that should be of interest to ana lytical scientists and deserve their input. References (1) William Horwitz, Anal. Chem., 50 (6), 521A (1978). (2) Robert M. Hodges, ibid., ρ 531Α. (3) R. A. Libby, ibid. (10), 575A (Sept. 1978).
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CIRCLE 155 ON READER SERVICE CARD ANALYTICAL CHEMISTRY, VOL. 51, NO. 6, MAY 1979 · 581 A
