ML090780733

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G20090151/EDATS: OEDO-2009-0128 - Jack W. Roe Ltr Request for 10 CFR Part 26 Enforcement Discretion - Response
ML090780733
Person / Time
Site: Nuclear Energy Institute
Issue date: 03/27/2009
From: Mallett B
NRC/EDO, Office of Nuclear Security and Incident Response
To: Roe J
Nuclear Energy Institute
Harris P
References
EDATS: OEDO-2009-0128, G20090151, OEDO-2009-0128
Download: ML090780733 (3)


Text

March 27, 2009 Mr. Jack W. Roe Director, Security Nuclear Generation Division Nuclear Energy Institute 1776 I Street, NW, Suite 400 Washington, DC 20006-3708

Dear Mr. Roe:

I am responding to your letter dated March 13, 2009 (ADAMS Accession No. ML090780477),

that requested enforcement discretion for two requirements in Title 10 of the Code of Federal Regulations, Part 26 (10 CFR Part 26), Fitness for Duty Programs. The two requirements are associated with 10 CFR Part 26, Subpart F, initial drug and validity testing at licensee testing facilities (LTFs).

Your letter stated, in part, that the requirements in the final version of sections 26.137(d)(5) and 26.137(e)(6)(v) are not consistent with the former (54 FR 24494; June 7, 1989, as amended) and proposed (70 FR 50442; August 26, 2005) Part 26 rules. You also stated that these sections should refer to LTF technicians instead of laboratory analysts; that the subject requirements should use normal specimens instead of donor specimens; that the normal specimens need not be a clearly identifiable quality control sample; and that the proposed rule did not state that the control must be positive, as certified by a Department of Health and Human Services-certified laboratory. You concluded by stating that if the requirements are not changed the industry would incur unnecessary burden and cost to meet the requirements of the final rule.

My staff has reviewed your request and found that the language in the final rule does not appear to accurately reflect the testing requirements necessary for LTFs as described in the proposed rule and intended in the final rule. We also found that these inaccuracies, if left uncorrected, could result in an unintended regulatory burden on licensees and other entities that operate LTFs. To address this, we are proposing an Enforcement Guidance Memorandum that would grant enforcement discretion for the affected requirements of 10 CFR Part 26 and will issue a Regulatory Information Summary to inform the industry and other external stakeholders of this action. Once we have these and make a final decision on them, we will inform you. The staff will also continue its interaction with the public and industry in its consideration of proposed rulemaking related to these matters.

J. Roe I appreciate you raising these issues to the NRC. If you have any questions regarding the information contained in this letter, please contact me.

Sincerely,

/RA/

Bruce S. Mallett Deputy Executive Director for Reactor and Preparedness Programs Office of the Executive Director for Operations cc: M. Fertel, President and CEO, NEI

ML090780733; ADAMS Package: ML090780765; Log No:NSIR-09-0109 OFFICE NSIR/SPM NSIR/DSP Tech Ed RES OGC NAME PHarris CErlanger*

via email via email CLui* via email

BJones, NLO DATE 03/20/09 03/23/09 03/20/09 03/19/09 03/24/09 OFFICE NRR/ADRO OE NSIR/DSO NSIR/OD EDO NAME BBoger* via E-mail CCarpenter GBowman for RCorreia (SMorris for)

RZimmerman BMallett DATE 03/19/09 03/25/09 03/24/09 03/26/09 03/27/09