Regulatory Implications

This Report culminates in the presentation of the principles and framework for a comprehensive and risk-based hazardous waste classification system. NCRP does not propose a particular implementation of the proposed classification system (e.g., a particular quantification in terms of limits on concentrations of hazardous substances in each waste class) this is most appropriately left to governmental policy organizations. The relationship of the proposed risk-based waste classification system to existing regulations is discussed in Section 7.2. 

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Bosnjakovic, B., P.H. van Dijkum, M.C. O Riordan, and J. Sinnaeve, eds., Proceedings of Exposure to Enhanced Natural Radiation and Its Regulatory Implications, Sci. Total Environ., Volume 45 (1985)... 

Jacobi, W. and Paretzke H.G. 1985, Risk Assessment for Indoor Exposure to Radon Daughters, In Proceedings, Seminar on Exposure to Enhanced Natural RAdiation and Its Regulatory Implications, Maastricht, the Netherlands, March 25-27, Elsvier Science Publisher, Amsterdam. 

Reineking, A., Becker K.H. and Porstendorfer, J., Measurement of the Unattached Fractions of Radon Daughters in Houses, Presented to the Seminar on Exposure to Enhanced Natural Radiation and its Regulatory Implications, Maastricht, The Netherlands (1985). 

We have previously documented the methodology (Marks et al., 1985a) and presented a summary of the technique (Marks et al., 1985b) at the Maastricht, The Netherlands, Seminar on Exposure to Enhanced Natural Radiation and Its Regulatory Implications. This paper represents a synthesis of the work we have conducted to date on risk assessment at uranium mill tailings vicinity properties. 

Association (ICB A), an organisation consisting of carbon black manufacturers inNorth America and Europe. Aspects covered include not only the occupational health research sponsored by the ICB A, but also an overview of the major health perspectives associated with carbon black and their corresponding regulatory implications. 19 refs. 

The potential for QT prolongation and proarrhythmia by non-antiarrhythmic drugs clinical and regulatory implications. Report on a policy conference of the European Society of Cardiology. European Heart Journal, 21, 1216-1231. 

Gaps can be addressed by either facility modifications (which have capital expenditure implications) or process modifications (which have product implications) or indeed formulation modifications (which have potential regulatory implications). Other options may include selection of new equipment, rental or procurement options and the latter will impact on transfer cost and timelines. 

Finlayson-Pitts, B. J., and J. N. Pitts, Jr., Atmospheric Chemistry of Tropospheric Ozone Formation Scientific and Regulatory Implications, J. Air Waste Manage. Assoc., 43, 1091-1100 (1993). 

Sam T. Regulatory implications of excipient changes in medicinal products. Drug Info J 2000 34 875-894. 

As citrus fruits and their products contribute substantially to the American diet and are consumed in great abundance, we believe the time is appropriate to review in detail some important nutritional and quality properties of this important fruit. Twenty-eight scientists joined with us to cover extensively subjects in the following areas nutrition and health quality as related to specific biochemical components effects of handling and processing quality control and evaluation regulatory implication and adulteration. 

Reference values are intended to characterize the upper margin of a current background contamination of a pollutant at a given time. For contaminants in the indoor environment reference values may be calculated applying the procedure as for environmental toxins in body fluids (Ewers et al., 1999). Reference values for pollutants in house dust were reviewed recently by Butte (2003). It has to be emphasized that a reference value has no health meaning nor regulatory implication. 

Gorsuch JW, Janssen CR, Lee CM, Reiley MC, editors. 2002. The biotic ligand model for metals current research, future directions, regulatory implications. Comp Biochem Physiol C 133 1-343. 

Staples CA, Werner AF. 1985. Priority pollutant assessment in the USA Scientific and regulatory implications. Toxic Subst J 6 186-200. 

Haverkamp, W., Breithardt, G., Camm, A.J., Janse, M.J., Rosen, M.R., Antzelevitch, C., Escande, D., Franz, M., Malik, M., Moss, A., Shah, R. (2000). The potential for QT prolongation and proarrhythmia by non-antiarrhythmic drugs clinical and regulatory implications. Report on a policy conference of the European Society of Cardiology. Eur. Heart J. 21 1216-31. 

Gorsuch J. W., Janssen C. R., Lee C. M., and Reiley M. C. (eds.) (2002) Special Issue The Biotic Ligand Model for Metals—Current Research, Future Directions, Regulatory Implications. Comp. Biochem. Physiol. 133C, 343pp. 

Finlayson-Pitts BJ, Pitts JNJ. 1993. Atmospheric chemistry of tropospheric ozone formation Scientific and regulatory implications. J Air Waste Manage Assoc 43 1091-1100. 

Hill, R. N. (1994). Regulatory implications Perspective of the U.S. Environmental Protection Agency. In Handbook cf Carcinogen Testing, 2nd edition, Milman, H. A., and Weisburger, E. K., eds., William Andrew PubUshing/Noyes, Norwich, NY, pp. 1-893. 

So change is upon us. Slower than other industry verticals (like capital markets and financial services)—reflecting the very conservative and risk adverse nature of the life sciences industry. But there are still insufficient standards in place with a number of relatively new regulatory implications such as 21 CFR Part 11 and HIPAA—further complicated by varying interpretations of these regulations. And change itself is costly and resource intensive and must deal with behavioral modification and human nature s resistance to change. 

Chapman, G. et al. (1987) Regulatory implications of contaminants associated with sediments. In Fate and Effects of Sediment-Bound Chemicals in Aquatic Systems, eds. K.L. Dickson et al, pp. 413-425. New York Pergamon Press. 

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