Rulemaking could compel changes to current practices involving commercial grade item dedication, use of accredited calibration laboratories, and acceptance of design and analysis software.

The U.S. Nuclear Regulatory Commission (NRC) has expressed the need for clarified regulations and guidance regarding requirements under Title 10 of the Code of Federal Regulations Part 21 (10CFR21), "Reporting of Defects and Noncompliance." These regulations include requirements for commercial-grade item dedication and for reporting defects and noncompliance. Although the NRC has issued information notices and initiated vendor outreach efforts, it believes that "rulemaking would provide a more holistic and effective solution."

EPRI is engaging NRC to participate in the rulemaking process as appropriate and to assess its potential impacts on the operating and new nuclear reactors. NRC has stated its openness to working with industry stakeholders such as the EPRI Joint Utility Task Group to solicit input and discuss proposed changes during the rulemaking process.

The regulatory changes could affect a nuclear plant's ability to obtain and accept items needed to support operation and maintenance of safety-related equipment in a timely manner. For example, the NRC has informally communicated a new expectation that a methodology similar to commercial grade item dedication be used to accept design and analysis software for use in safety-related applications. Verification and validation alone may not be sufficient to accept these types of software. Regulatory changes also could require revisions to a series of EPRI guidance documents associated with commercial grade item dedication (see table).

If the NRC implements new regulations, EPRI recommends that nuclear plant licensees perform a thorough review of the new verbiage; incorporate new or revised requirements into existing training programs, procedures, processes, forms, asset management and resource planning system functionality; and collaborate to ensure the intent of new language is understood and consistently implemented.

Please contact Marc Tannenbaum at (704) 595-2609 or mtannenbaum@epri.com if you have questions.