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May 28, 2013
NRC proposal includes QA revisions

The Nuclear Regulatory Commission (NRC) has proposed changes to regulations governing the packaging and transportation of radioactive material.  The intent of the proposal is to harmonize U.S. requirements with standards developed by the International Atomic Energy Agency (IAEA). 

The proposed changes include updating an exemption from certain NRC rules for natural materials and ores containing naturally occurring radionuclides at low levels that have been processed, provided the activity concentration is below a specified threshold.  Apart from actions to achieve harmonization with the IAEA standards, the NRC is also proposing updates to its quality assurance (QA) program requirements to allow licensees to make certain changes to their programs without obtaining prior approval from the NRC.

The proposal parallels a proposal published August 12, 2011, by the Department of Transportation’s (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) that was also directed at harmonization with the 2009 edition of IAEA’s Regulations for the Safe Transport of Radioactive Material (TS-R-1).   Currently, the DOT and the NRC co-regulate the transport of radioactive materials in the United States. 

Fissile material exemption

The NRC is proposing a total of 13 changes to improve the consistency of its standards with those of TS-R-1.  In addition to the naturally occurring radionuclides exemption noted above, the changes include revised definitions of low specific activity (LSA) material and uranium–natural, depleted, enriched and adoption of the Class 5 impact test for special form of radioactive material with a mass under 500 grams. 

The proposal would also modify NRC’s current fissile material exemption for shipments of uranium with very low enrichment (a maximum of 1 percent).  Specifically, the NRC is proposing to reinstate the requirement that the fissile material must be distributed homogeneously throughout the package contents and not form a lattice arrangement.  The intent of this proposed change is to reduce the small chance that uranium with very low enrichment could inadvertently trigger a nuclear chain reaction.

QA program

Under current requirements, virtually every change to a QA program, including correcting typographical errors, must first be approved by the NRC.  Under the proposal, licensees would be allowed to make changes without prior NRC approval provided the changes do not reduce the commitments in an approved QA program.  Examples of changes to QA programs the NRC would not view as reducing a commitment made to the NRC include:

  • Use of a QA standard approved by the NRC that is more recent than the QA standard in the current quality assurance program.
  • Use of generic organizational position titles that clearly denote the function of the position, supplemented as necessary by descriptive text rather than specific titles, provided there are no substantive changes to either the functions of the position or reporting responsibilities.
  • Use of generic organizational charts to indicate functional relationships, authorities, and responsibilities, or alternatively, the use of descriptive text.
  • Elimination of QA program information that duplicates language in QA regulatory guides and QA standards to which the holder of the QA program approval has committed on record.
  • Organizational revisions that ensure that persons and organizations performing QA functions continue to have the requisite authority and organizational freedom, including sufficient independence from cost and schedule when those are opposed to safety considerations.

Those with approved QA programs would also need to maintain records of all QA program changes.  Further, the NRC is proposing to require that QA program approval holders would need to inform the NRC of changes to their QA program every 24 months provided those changes do not reduce any commitment in the QA program.

NRC’s proposal was published in the May 16, 2013, FR.

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