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April 21, 1999

The Commission has approved the staff's proposal to grant OSRAM, Inc. an exemption from all sections of 10 CFR Part 20 that refer to quantities in Appendix B to Part 20 and instead require OSRAM, Inc. to use equivalent quantities calculated using the new internal dosimetry models as described in ICRP Publication 68. The Commission has also approved the staff granting exemptions on a case-by-case basis, based on the precedent set by the decision in this case. Should a significant number of exemption requests be received, the staff should provide this information to the Commission for consideration of a rulemaking effort to revise the affected portions of Part 20.

Generically, the staff should consider this issue in the development of future rulemakings related to the adoption of Industry Standards so as not to unnecessarily tie the agency and its licensees to industry methodologies that are static and quickly dated. Methodologies developed to show compliance with industry standards are dynamic in nature and continually evolving; therefore, rather than incorporating methodologies and protocols into the regulations themselves, the staff should instead incorporate the standards through reference in guidance documents which can be updated as needed to reflect the current state of the art. The final measure of the licensee's program should be compliance with the dose limits, not with a set of values that were meant to ease the calculational burden of the licensees.