Paul Harris

U.S. NUCLEAR REGULATORY COMMISSION July 2015

OFFICE OF NUCLEAR REGULATORY RESEARCH Revision 0

REGULATORY GUIDE Technical Lead

REGULATORY GUIDE 5.84

(Draft was issued as DG-5036, dated November 2014)

FITNESS-FOR-DUTY PROGRAMS AT NEW REACTOR

CONSTRUCTION SITES

A. INTRODUCTION

Purpose

This regulatory guide describes methods and procedures that the staff of the U.S. Nuclear

Regulatory Commission (NRC) considers acceptable when developing fitness-for-duty (FFD) programs

at new reactor construction sites. Licensees, applicants, and contractors/vendors (C/Vs) who implement

FFD programs should consider this guidance when preparing an application for a combined license

(COL), a limited work authorization (LWA), construction permit (CP), or early site permit (ESP).

Applicable Rules and Regulations

• Part 26 of Title 10 of the Code of Federal Regulations (10 CFR Part 26), “Fitness-for-Duty

Programs,” (Ref. 1), describes the categories of licensees and permit holders who are required to

implement an FFD program. Section 26.4(f) requires that any individual who is constructing or

directing the construction of safety or security related SSCs (structures, systems and components)

shall be subject to an FFD program that meets the requirements of Subpart K, “FFD Programs for

Construction,” unless the licensee or other entity requires these individuals to meet an FFD

program that meets all of the requirements of Part 26, except for Subparts I (“Managing Fatigue”)

and K.

Purpose of Regulatory Guides

The NRC issues regulatory guides to describe methods that the staff considers acceptable for use

in implementing specific parts of the agency’s regulations, to explain techniques that the staff uses in

evaluating specific problems or postulated accidents, and to provide guidance. However, regulatory

guides are not substitutes for regulations and compliance with them is not required. Methods and

solutions that differ from those set forth in regulatory guides will be deemed acceptable if they provide a

basis for the findings required for the issuance or continuance of a permit or license by the Commission.

Written suggestions regarding this guide or development of new guides may be submitted through the NRC’s public Web site under the

Regulatory Guides document collection of the NRC Library at http://www.nrc.gov/reading-rm/doc-collections/reg-guides/contactus.html.

Electronic copies of this regulatory guide, previous versions of this guide, and other recently issued guides are available through the NRC’s

public Web site under the Regulatory Guides document collection of the NRC Library at http://www.nrc.gov/reading-rm/doc-collections/. The

regulatory guide is also available through the NRC’s Agencywide Documents Access and Management System (ADAMS) at 

http://www.nrc.gov/reading-rm/adams.html, under ADAMS Accession No. ML15083A412. The regulatory analysis may be found in ADAMS

under Accession No. ML15083A411 and the staff responses to the public comments on DG-5036 may be found under ADAMS Accession No.

ML15083A410
RG 5.84, Page 2

Paperwork Reduction Act

This regulatory guide contains information collection requirements covered by 10 CFR Part 26

that the Office of Management and Budget (OMB) approved under OMB control number 3150-0146. The

NRC may neither conduct nor sponsor, and a person is not required to respond to, a collection of

information unless the requesting document displays a current valid OMB control number.

B. DISCUSSION

Reason for Issue

This guide endorses the methods described in the industry guidance document Nuclear Energy

Institute (NEI) 06-06, “Fitness-for-Duty Program Guidance for New Nuclear Power Plant Construction

Sites,” Revision 6, dated April 2013, (Ref. 2) with the exception that is identified in the Staff Regulatory

Guidance section, as acceptable methods of meeting the Commission’s regulations.

Background

In 2008 and 2009, respectively, the NRC revised its comprehensive FFD regulations in 10 CFR

Part 26 to adopt and reflect selected provisions of the U.S. Department of Health and Human Services

“Mandatory Guidelines for Federal Workplace Drug Testing Programs” (Ref. 3), and amended the

Commission’s access authorization requirements contained in 10 CFR Part 73, “Physical Protection of

Plants and Materials” (Ref. 4).

FFD programs as described in 10 CFR 26.4 are applicable to specific categories of individuals. 10

CFR 26.4(a) requires all persons who have unescorted access to nuclear reactor protected areas to be

subject to an FFD program that meets all of 10 CFR Part 26, except for Subpart K (FFD program for

construction). 10 CFR 26.4(f) requires that “Any individual, who is constructing or directing the

construction of safety or security related SSCs shall be subject to an FFD program that meets the

requirements of Subpart K, unless the licensee or other entity subjects these individuals to an FFD

program that meets all of the requirements of 10 CFR Part 26, except for Subparts I and K of this part,”

(fatigue management and FFD program for construction, respectively), as might be encountered at a site

with an operating reactor adjacent to a reactor under construction. The introduction to NEI 06-06,

Revision 6, states that it remains in effect until the construction site transitions to an operations related

FFD program, requiring implementation of 10 CFR Part 26, Subparts A-I, N and O. It also provides that it

does not include guidance for those individuals with duties specified in 10 CFR 26.4(f) who may also be

subject to an FFD program that meets all the requirements of 10 CFR Part 26, except Subparts I and K.

Harmonization with International Standards

The International Atomic Energy Agency (IAEA) has established a series of safety guides and

standards constituting a high level of safety for protecting people and the environment. IAEA safety

guides present international good practices and increasingly reflects best practices to help users striving to

achieve high levels of safety. The NRC staff reviewed guidance from the IAEA and other organizations

and found guidance applicable to FFD. However, staff did not identify any other standards that provided

detailed guidance specifically addressing requirements of 10 CFR Part 26.
RG 5.84, Page 3

Documents Discussed in Staff Regulatory Guidance

This regulatory guide endorses the use of a process developed by NEI. NEI 06-06 may contain

references to other standards or guidance documents (“secondary references”). If a secondary reference

has itself been incorporated by reference into NRC regulations as a requirement, then licensees and

applicants must comply with that standard as set forth in the regulation. If the secondary reference has

been endorsed in a regulatory guide as an acceptable approach for meeting an NRC requirement, then the

standard constitutes a method acceptable to the NRC staff for meeting that regulatory requirement as

described in the specific regulatory guide. If the secondary reference has neither been incorporated by

reference into NRC regulations nor endorsed in a regulatory guide, then the secondary reference is neither

a legally-binding requirement nor a “generic” NRC approval as an acceptable approach for meeting an

NRC requirement. However, licensees and applicants may consider and use the information in the

secondary reference, if appropriately justified and consistent with current regulatory practice, consistent

with applicable NRC requirements.

C. STAFF REGULATORY GUIDANCE

The NRC staff considers conformance with NEI 06-06, Revision 6, dated April 2013, to be a

method that is acceptable for use in satisfying the regulations with respect to the implementation of FFD

programs at new reactor construction sites, subject to the following conditions:

In NEI 06-06, Revision 6, section 2.1, the sentence after a discussion of Item h states: “In

addition, individuals who perform the duties specified in 10 CFR 26.4(e) may be included in the program

covered by this guidance.” This sentence is inconsistent with the discussion in Section 1 regarding the

regulatory treatment of these individuals. As stated in Section 1 of NEI 06-06, “It [NEI 06-06] does not

include guidance for those individuals with duties specified in 10 CFR 26.4(e) who must be subject to an

FFD program that meets all the requirements of 10 CFR Part 26, except Subparts I and K.” The NRC staff

has determined that NEI 06-06, Revision 6, is not an acceptable method of complying with the

requirements specified in 10 CFR 26.4(e). Individuals listed in 10 CFR 26.4(e) must be subject to all the

requirements of Part 26, except Subparts I and K, and NEI 06-06, Revision 6, does not provide guidance

for those requirements. For these reasons the sentence quoted above from section 2.1 of NEI 06-06,

Revision 6 should be deleted.

Although examples are appropriate as general templates for illustrating and reinforcing the

guidance in NEI 06-06 and associated regulatory guidance, the NRC endorsement of NEI 06-06 should

not be considered a determination that each NEI 06-06 example applies to any or all licensees, applicants,

or other entities as presented and written in NEI 06-06 or this regulatory guide. A licensee should ensure

that any example provided applies to its particular circumstance before implementation.
RG 5.84, Page 4

D. IMPLEMENTATION

The purpose of this section is to provide information on how applicants and licensees1 may use

this guide and information regarding the NRC’s plans for using this regulatory guide. In addition, it

describes how the NRC staff complies with 10 CFR 50.109, “Backfitting” and any applicable finality

provisions in 10 CFR Part 52, “Licenses, Certifications, and Approvals for Nuclear Power Plants”.

Use by Applicants and Licensees

Applicants and licensees may voluntarily2 use the guidance in this document to demonstrate

compliance with the underlying NRC regulations. Methods or solutions that differ from those described in

this regulatory guide may be deemed acceptable if they provide sufficient basis and information for the

NRC staff to verify that the proposed alternative demonstrates compliance with the appropriate NRC

regulations. Current licensees may continue to use guidance the NRC found acceptable for complying

with the identified regulations as long as their current licensing basis remains unchanged.

Licensees may use the information in this regulatory guide for actions which do not require NRC

review and approval such as changes to a facility design under 10 CFR 50.59, “Changes, Tests, and

Experiments.” Licensees may use the information in this regulatory guide or applicable parts to resolve

regulatory or inspection issues.

Use by NRC Staff

The NRC staff does not intend or approve any imposition or backfitting of the guidance in this

regulatory guide. The NRC staff does not expect any existing licensee to use or commit to using the

guidance in this regulatory guide, unless the licensee makes a change to its licensing basis. The NRC staff

does not expect or plan to request licensees to voluntarily adopt this regulatory guide to resolve a generic

regulatory issue. The NRC staff does not expect or plan to initiate NRC regulatory action which would

require the use of this regulatory guide. Examples of such unplanned NRC regulatory actions include

issuance of an order requiring the use of the regulatory guide, requests for information under

10 CFR 50.54(f) as to whether a licensee intends to commit to use of this regulatory guide, generic

communication, or promulgation of a rule requiring the use of this regulatory guide without further

backfit consideration.

During regulatory discussions on plant specific operational issues, the staff may discuss with

licensees various actions consistent with staff positions in this regulatory guide, as one acceptable means

of meeting the underlying NRC regulatory requirement. Such discussions would not ordinarily be

considered backfitting even if prior versions of this regulatory guide are part of the licensing basis of the

facility. However, unless this regulatory guide is part of the licensing basis for a facility, the staff may not

represent to the licensee that the licensee’s failure to comply with the positions in this regulatory guide

constitutes a violation.

If an existing licensee voluntarily seeks a license amendment or change and (1) the NRC staff’s

consideration of the request involves a regulatory issue directly relevant to this new or revised regulatory

guide and (2) the specific subject matter of this regulatory guide is an essential consideration in the staff’s

1 In this section, “licensees” refers to licensees of nuclear power plants under 10 CFR Parts 50 and 52; and the term

“applicants,” refers to applicants for licenses and permits for (or relating to) nuclear power plants under 10 CFR Parts

50 and 52.

2 In this section, “voluntary” and “voluntarily” means that the licensee is seeking the action of its own accord, without

the force of a legally binding requirement or an NRC representation of further licensing or enforcement action.
RG 5.84, Page 5

determination of the acceptability of the licensee’s request, then the staff may request that the licensee

either follow the guidance in this regulatory guide or provide an equivalent alternative process that

demonstrates compliance with the underlying NRC regulatory requirements. This is not considered

backfitting as defined in 10 CFR 50.109(a)(1) or a violation of any of the issue finality provisions in 10

CFR Part 52.

Additionally, an existing applicant may be required to comply with new rules, orders, or guidance

if 10 CFR 50.109(a)(3) applies.

If a licensee believes that the NRC is either using this regulatory guide or requesting or requiring

the licensee to implement the methods or processes in this regulatory guide in a manner inconsistent with

the discussion in this Implementation section, then the licensee may file a backfit appeal with the NRC in

accordance with the guidance in NUREG-1409, “Backfitting Guidelines”, (Ref. 5) and the NRC

Management Directive 8.4, “Management of Facility-Specific Backfitting and Information Collection”

(Ref. 6).
RG 5.84, Page 6

REFERENCES3

1. U.S. Code of Federal Regulations (CFR), Part 26, “Fitness-for-Duty Programs,” Chapter 1, Title

10, “Energy.”

2. Nuclear Energy Institute (NEI) 06-06, “Fitness-for-Duty Program Guidance for New Nuclear

Power Plant Construction Sites,” Revision 6, NEI, Washington, DC, April 2013.

3. U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services

Administration, “Mandatory Guidelines for Federal Workplace Drug Testing Programs,” Federal

Register, Vol. 73, No. 228, November 25, 2008, pp. 71858-71938.

4. CFR, Part 73, “Physical Protection of Plants and Materials,” Chapter 1, Title 10, “Energy.”

5. U.S. Nuclear Regulatory Commission (NRC), NUREG-1409, “Backfitting Guidelines.”

6. NRC, Management Directive 8.4, “Management of Facility Specific Backfitting and

Information.”

3 Publicly available NRC documents are available electronically online through the NRC Library on the NRC’s public

Web site at http://www.nrc.gov/reading-rm/doc-collections/ and through the NRC’s Agencywide Documents Access

and Management System (ADAMS) at http://www.nrc.gov/reading-rm/adams.html. The documents can also be 

viewed online or printed for a fee in the NRC’s Public Document Room (PDR) at 11555 Rockville Pike, Rockville, MD.

For problems with ADAMS, contact the PDR staff at 301-415-4737 or (800) 397-4209; fax (301) 415-3548; or email pdr.resource@nrc.gov.