Download:
pdf |
pdfDRAFT SUPPORTING STATEMENT FOR INFORMATION COLLECTIONS CONTAINED IN
THE REGULATORY IMPROVEMENTS FOR PRODUCTION AND UTILIZATION FACILITIES
TRANSITIONING TO DECOMMISSIONING PROPOSED RULE
10 CFR PART 26
FITNESS-FOR-DUTY PROGRAMS
DESCRIPTION OF INFORMATION COLLECTION
The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its regulations that
govern production and utilization facility licensee activities during decommissioning. The NRC’s
goals in amending these regulations are to provide for an efficient decommissioning process;
reduce the need for exemptions from existing regulations and license amendment requests;
address other decommissioning issues deemed relevant by the NRC; and support the principles
of good regulation, including openness, clarity, and reliability. The proposed rule covers a wide
range of topics, including the following that would result in incremental changes in
recordkeeping and reporting requirements relative to existing rules:
•
•
•
•
•
•
•
•
Emergency preparedness,
Physical security,
Cyber security,
Fitness for duty,
Training requirements for a fuel handler program,
Decommissioning funding assurance,
Offsite and onsite financial protection requirements and indemnity agreements, and
Current regulatory approaches to decommissioning.
This supporting statement describes how the proposed rule will impact the information
collections in 10 CFR Part 26 (3150-0146). The supporting statements describing changes to 10
CFR Part 20 (3150-0014), 10 CFR Part 50 (3150-0011), 10 CFR Part 52 (3150-0151). 10 CFR
Part 72 (3150-0132), and 10 CFR Part 73 (3150-0002) have been submitted under the
respective clearances.
Affected Entities
The proposed revisions to Part 26 would impact only Part 52 licensees after the NRC has
docketed their Section 52.110(a) certifications of permanent cessation of operations and
permanent removal of fuel from the reactor vessel. As a result of the proposed revisions to the
Part 26 applicability provisions in Section 26.3(a), there would no longer be a need for Part 52
licensees undergoing decommissioning to comply with Part 26 information collections after the
NRC has docketed their Section 52.110(a) certifications. The NRC staff estimates that no
Part 52 nuclear power reactors will permanently shut down during the 3-year period covered by
this supporting statement.
2
Information Collections
This supporting statement covers recordkeeping, reporting, and third-party disclosure
requirements that apply to the following types of information collections:
•
Information describing the FFD drug and alcohol (D&A) testing program of a licensee or
other entity. FFD program policy, FFD program procedures, and trainings provided on
the FFD program.
•
Information documenting testing protocols and testing personnel qualifications at
Licensee Testing Facilities (LTFs) and U.S. Department of Health and Human Services’
(HHS)-certified laboratories. Laboratory testing policies and procedures, laboratory
personnel qualification and training records, quality assurance (QA) and quality control
(QC) records, and licensee and other entity contracts with testing laboratories.
•
Information documenting D&A specimen collection, testing, and results review
processes. Specimen chain of custody records, laboratory testing results, test results
reviews, qualification and training records of personnel performing roles in the FFD
program (e.g., Medical Review Officers (MROs), Substance Abuse Expert (SAEs), FFD
program personnel), and contracts with service providers.
•
Reports on FFD program performance. Periodic reports to the NRC on the D&A testing
program and fatigue management program (annual reports on program performance),
and more timely reports (24 hours, 30 days) for significant FFD policy violations or
programmatic failures.
•
Information on personnel subject to an FFD program. Records for authorization (signed
consent forms to access or release information, self-disclosure, employment history,
credit history, criminal background check, suitable inquiry); training and examination
records, fitness determinations, FFD program violations).
•
Information on audits. Records on audits performed on a periodic basis of the FFD
program, testing laboratories, collection site, and employee assistance program (EAP).
•
Records on work hour controls (fatigue management). Records of work hours of
individuals, records of shift schedules and cycles, documentation of waivers issued,
work hour reviews, and fatigue assessments.
This clearance also includes three Portable Document Form (PDF) electronic reporting forms
(i.e., fillable-fileable PDFs) that were approved by the Office of Management and Budget (OMB)
under Information Collection Request (ICR) 3150-0146 on November 13, 2014:
•
•
•
NRC Form 890 – Single Positive Test Form
NRC Form 891 – Annual Reporting Form for Drug and Alcohol Tests
NRC Form 892 – Annual Fatigue Reporting Form
Licensees and other entities can voluntarily use these fillable-fileable PDFs to report information
required under sections 26.417(b)(2) and 26.717 for FFD D&A testing programs, and
section 26.203(e) for fatigue management programs. As of the calendar year 2015 annual
reporting cycle, all sites now use fillable-fileable PDFs.
3
A more detailed description of each provision is provided at the end of this supporting statement
in “Description of Information Collection Requirements.”
A.
JUSTIFICATION
1.
Need for the Collection of Information
The information collections contained in Part 26 enable effective and efficient
regulatory oversight of affected licensee and other entities through inspection and
the assessment of FFD program performance to maintain public health and safety,
promote the common defense and security, and to protect the environment. The
NRC uses these information collections to assess licensee and other entity
compliance with Part 26 through periodic NRC inspections, and to take corrective
actions, as needed. The NRC also uses these information collections to evaluate
the effectiveness of the regulations and to take additional actions, as needed, such
as issuing guidance or amending Part 26 through rulemaking. The information
collections also provide due process protections to each individual subject to an
FFD program.
2.
Agency Use and Practical Utility of Information
The NRC uses the information included in the records and reports required by
Part 26 for one or more of the following reasons:
3.
•
To monitor licensee and other entity compliance with Part 26 requirements
to ensure that each FFD Program is adequate to protect public health and
safety, promote the common defense and security, and protect the
environment;
•
To be informed of FFD-related performance issues in order to evaluate the
need to implement timely regulatory actions to restore compliance, verify
corrective actions, implement licensing actions, conduct public outreach,
and/or inspect NRC-licensed activities; and,
•
To evaluate the performance of D&A testing programs and fatigue
management programs through the collection and analysis of annual
program performance information to identify trends, lessons learned, and
site-specific or industry-wide issues requiring NRC licensing or inspection
response, generic communication, or rulemaking. The NRC staff also
develops summaries of the D&A testing program performance to inform the
public on industry performance.
Reduction of Burden Through Information Technology
The NRC has issued Guidance for Electronic Submissions to the NRC, which
provides direction for the electronic transmission and submittal of documents to the
NRC. Electronic transmission and submittal of documents can be accomplished via
the following avenues: the Electronic Information Exchange (EIE) process, which is
available from the NRC's “Electronic Submittals” Web page, by Optical Storage
Media (OSM) (e.g. CD-ROM, DVD), by facsimile or by e-mail.
4
The proposed rule would not impact the proportion of documents submitted to the
NRC electronically.
4.
Effort to Identify Duplication and Use Similar Information
No sources of similar information are available. There is no duplication of
requirements.
5.
Effort to Reduce Small Business Burden
Not applicable.
6.
Consequences to Federal Program or Policy Activities if the Collection Is Not
Conducted or Is Conducted Less Frequently
If the records and reports required by Part 26 are not collected or collected less
frequently, then the NRC would not be able to adequately:
•
independently monitor licensee and other entity compliance and ensure that
each FFD Program is adequate to protect public health and safety, promote
the common defense and security, and protect the environment;
•
verify the scientific accuracy and validity of test results and to ensure that
the rights of individuals subject to testing are protected;
•
complete timely evaluations of FFD-related performance issues and
implement regulatory actions to restore compliance, assess corrective
actions, inform the public, and/or propose changes to regulations or
guidance; and
•
inform the public in a timely manner on FFD Program performance trends,
lessons learned, and site-specific or industry-wide issues.
Complete and accurate information for each individual (i.e., past employment, past
periods of authorization, any authorization denial or unfavorable termination, past
arrest record, and other potentially disqualifying FFD information (PDI)) must be
available at the time that FFD authorization decisions are made. If the information
on an individual is not complete at the time of an FFD authorization decision, the
inappropriate granting of unescorted access authorization to an NRC-licensed
facility may occur.
Records and reports associated with fatigue management ensure that persons are
capable of performing their assigned tasks safely and competently. If fatigue
management records and reports are not collected or collected less frequently,
internal licensee reviews or NRC oversight during inspections may not identify
programmatic weaknesses that may result in persons who are fatigued being
assigned to perform covered duties. This could result in conditions adverse to
safety and/or security at operating nuclear power reactors.
5
7.
Circumstances which Justify Variations from OMB Guidelines
The proposed revision to Part 26 would not conflict with OMB Guidelines.
8.
Consultations Outside the NRC
Opportunity for public comment on the information collection requirements for this
clearance package has been published in the Federal Register.
9.
Payment or Gift to Respondents
Not applicable.
10. Confidentiality of Information
Confidential and proprietary information is protected in accordance with NRC
regulations at 10 CFR 9.17(a) and 10 CFR 2.390(b). However, no information
normally considered confidential or proprietary is requested by the proposed rule.
11. Justification for Sensitive Questions
This proposed rule does not request sensitive information.
12. Estimated Burden and Burden Hour Cost
Detailed burden estimates are included in the supplemental burden Excel
spreadsheet titled, “Part 26 Burden Tables for the Regulatory Improvements for
Production and Utilization Facilities Transitioning to Decommissioning Proposed
Rule.”
The NRC staff does not anticipate any license holder will be submitting the
certifications described in Section 52.110(a) during the period of this clearance.
The overall estimated annual burden is 0 hours at an estimated annual cost of
$0.00 (0 hours x $288/hour).
Title
Annual Reporting
One-time Reporting
Annual Recordkeeping
One-time
Recordkeeping
TOTAL
Total Burden Summary
Responses
Hours
0
0
0
0
0
0
Cost
$0.00
$0.00
$0.00
0
0
$0.00
0
0
$0.00
*Each recordkeeper is counted as a single response. All one-time recordkeepers are included in the
annual recordkeeping total.
The $288 hourly rate used in the burden estimates is based on the Nuclear
Regulatory Commission’s fee for hourly rates as noted in 10 CFR 170.20, “Average
cost per professional staff-hour.” For more information on the basis of this rate, see
6
the Revision Of Fee Schedules; Fee Recovery For Fiscal Year 2021 (86 FR 32146;
June 16, 2021).
13. Estimate of Other Additional Costs
There are no additional costs.
14. Estimated Annualized Cost to the Federal Government
Because the proposed rule’s changes to Part 26 would not affect any entities during
the 3-year period covered by this supporting statement, there is no annualized cost
reduction for the NRC. However, the following table identifies the anticipated
reduced burden hours per action for the NRC should future entities be affected by
the proposed rule.
Annualized NRC Cost Reduction
NRC Action
Process
exemption
requests
Review FFD
policies and
procedures
Review records
Review and
evaluate report
Review
documentation
provided by SAE
Review and
analyze annual
fatigue
management
performance
report
Review and
analyze annual
FFD program
performance
report
Review, evaluate,
and respond to
24-hour report on
significant FFD
policy violation or
programmatic
failure
Rule Text
Provision
No.
Actions/
Year
Reduced
Burden
Hours/Action
Total
Reduced
Hours
Total Cost
Reduction
26.9
0
16
0
$0.00
26.27(d)
0
8
0
$0.00
26.27(h)
0
4
0
$0.00
26.77(c)
0
4
0
$0.00
26.187(f)
0
4
0
$0.00
26.717
0
10
0
$0.00
26.717
0
12
0
$0.00
26.719(b)
0
8
0
$0.00
7
NRC Action
Review, evaluate,
respond to a 30day report
detailing
investigation of
any testing errors
or unsatisfactory
performance
Total
Rule Text
Provision
No.
Actions/
Year
Reduced
Burden
Hours/Action
Total
Reduced
Hours
Total Cost
Reduction
26.719(c)
0
4
0
$0.00
0
$0.00
The staff has developed estimates of annualized costs to the Federal Government
related to the conduct of this collection of information. These estimates are based
on staff experience and subject matter expertise and include the burden needed to
review, analyze, and process the collected information and any relevant operational
expenses.
15. Reasons for Changes in Burden or Cost
Because the proposed rule’s changes to Part 26 would not affect any Part 52
decommissioning licensees during the 3-year period covered by this supporting
statement, there is no change in burden or cost from the proposed rule.
16. Publication for Statistical Use
The information being collected is not expected to be published for statistical use.
17. Reason for Not Displaying the Expiration Date
NRC Forms 890, 891, and 892 display the OMB clearance approval expiration date.
The remaining recordkeeping and reporting requirements for this information
collection do not use instruments such as forms or surveys. For this reason, there
are no data instruments on which to display an OMB expiration date.
18. Exceptions to the Certification Statement
None.
B.
COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS
Not applicable.
8
DESCRIPTION OF INFORMATION COLLECTION REQUIREMENTS CONTAINED IN THE
REGULATORY IMPROVEMENTS FOR PRODUCTION AND UTILIZATION FACILITIES
TRANSITIONING TO DECOMMISSIONING PROPOSED RULE
10 CFR PART 26
To correct an inconsistency within Section 26.3(a) that applies the fitness-for-duty (FFD)
requirements in Part 26 differently to Part 50 and Part 52 licensees undergoing
decommissioning, the proposed rule would clarify that Part 26 does not apply to Part 52
licensees once the NRC has docketed their Section 52.110(a) certifications. The proposed
Section 26.3(a) would specify that each holder of a combined license under Part 52 for which
the Commission has made the finding under Section 52.103(g) must comply with the
requirements of Part 26, except for Subpart K, until the NRC’s docketing of the license holder’s
license termination certifications described in Section 52.110(a). As a result of this proposed
change, the following information collections, all of which are covered by OMB Clearance 31500146, would no longer apply to Part 52 licensees after the NRC has docketed their Section
52.110(a) certifications:
10 CFR 26.4(j) requires that a licensee or other entity provide training to each individual subject
to Part 26 on the knowledge and abilities (KAs) listed in Section 26.29(a)(1) through (a)(10). In
addition, individuals subject to the D&A testing program of another Federal or State agency,
who have been granted authorization by a licensee or other entity under Part 26, must complete
training on any KA in Section 26.29(a) not included in the training provided by the Federal or
State agency. State and Federal agencies also must notify the licensee granting authorization of
any FFD policy violations by these individuals.
10 CFR 26.9 provides that the Commission may, upon application of any interested person or
upon its own initiative, grant exemptions from the requirements of Part 26, and specifies that
exemption requests must meet the provisions of 10 CFR 50.12 or 10 CFR 70.17. This reporting
requirement ensures that licensees seeking an exemption from any Part 26 requirement provide
the NRC with information to determine if the criteria for granting an exemption listed in
sections 50.12 or 70.17 have been met.
10 CFR 26.27(a) requires each licensee or other entity subject to Part 26 to establish,
implement, and maintain written policies and procedures designed to meet the performance
objectives in Section 26.23 and other requirements in Part 26. The written FFD policy is the
primary means of communicating information on the FFD program to individuals subject to
Part 26, and the FFD procedures are the primary means of documenting how the FFD program
is administered by the licensee or other entity. This requirement also ensures that the due
process rights of individuals are protected by providing information on the FFD policy and
consequences of not adhering to the policy.
10 CFR 26.27(b) requires each licensee or other entity to make a clear and concise FFD policy
statement readily available to all subject individuals specifies the minimum contents that must
be included in the policy statement. For example, the FFD policy must include a description of
the consequences of prohibited actions (abuse of legal drugs and alcohol, misuse of
prescriptions), alcohol abstinence requirements, factors that can affect the fitness-for-duty of an
individual, employee assistance programs, and responsibilities to report FFD concerns. This
requirement ensures that the current, specific, and concise information on the FFD policy is
available for review by all individuals subject to the FFD program. Section 26.713(d) also
ensures that superseded versions of the FFD policy are maintained.
9
10 CFR 26.27(c) requires that each licensee or other entity prepare and maintain written
procedures that describe the methods used to implement the FFD policy that meets the
requirements in Part 26. This requirement ensures that individuals that administer the FFD
program have detailed and specific information on the methods for testing drugs and alcohol
(e.g., the drug testing panel and testing cutoff levels); the conditions under which testing is
permitted (e.g., when an individual is selected for random testing he or she must report to the
collection site); how and why behavioral observation is conducted; and how authorization is
granted, maintained, reinstated, and withdrawn. This requirement contributes to the protection
of due process rights of individuals subject to Part 26, provides for prior notice, and ensures that
documentation is maintained in support of legal proceedings. Section 26.713(d) also ensures
that the licensee or other entity maintains superseded versions of the FFD procedures.
10 CFR 26.27(d) specifies that the NRC may, at any time, review the written FFD policy and
procedures of a licensee’s or other entity’s FFD program. This requirement ensures that NRC
has timely access to records, which is necessary to support inspection and the evaluation of
compliance with Part 26 requirements.
10 CFR 26.29(a) requires that the licensee-developed training program contain specific content
to ensure that individuals who are subject to Part 26 have specified KAs. This requirement
provides assurance that persons receive sufficient training in the KAs necessary to meet the
performance objectives in Section 26.23.
10 CFR 26.29(b) requires that all individuals subject to Part 26 successfully complete training
and pass a comprehensive examination on the KAs specified in Section 26.29(a)(1) through
(a)(10). The examination must be developed, maintained, and executed to provide assurance
that persons are adequately knowledgeable of Part 26 requirements.
10 CFR 26.29(c)(2) requires those individuals who already have completed the comprehensive
examination under 26.29(b), to complete refresher training on a nominal 12-month frequency (or
more frequently if a need is indicated). Refresher training provides assurance that persons
subject to Part 26 continue to be trustworthy, reliable, and fit for duty as demonstrated by their
knowledge and adherence to Part 26 requirements.
10 CFR 26.29(d) allows a licensee or other entity to accept the initial or annual refresher training
completed by an individual subject to Part 26 under another the FFD program of another license
or other entity, if the Section 26.26(b) training was successfully completed within the previous
12 months. The provision may reduce training burden on licensees and other entities that use
personnel that work for multiple regulated entities in a single year (e.g., short-term outage
workers that travel between licensee sites on a frequent basis).
Section 26.713(b)(1) establishes the recordkeeping requirements for Section 26.29(a), (b),
(c)(1) and (c)(2), and (d).
10 CFR 26.31(b)(1)(i) requires licensees and other entities to complete background
investigations, credit and criminal history checks, and psychological assessments of FFD
program personnel before their assignment to tasks directly associated with administration of
the FFD program. The background investigations, credit and criminal history checks, and
psychological investigations would be conducted under a nuclear power plant’s access
authorization program (implemented pursuant to 10 CFR Part 73). Section 26.31(b)(1)(i)
requires updates to the credit and criminal history checks, and psychological assessments
every 5 years, which ensure that FFD program personnel continue to be trustworthy and
10
reliable. This information ensures that a licensee can make an informed determination of
whether an individual is trustworthy, reliable, and able to service as a member of the FFD
program personnel staff. Affected individuals must provide this information to a licensee or other
entity to enable the completion of these evaluations. Section 26.713(f) establishes the
recordkeeping requirements of Section 26.31(b)(1)(i).
10 CFR 26.31(b)(1)(v) requires FFD program personnel to be subject to a BOP designed to
assure that they continue to meet the highest standards of honesty and integrity. When the
Medical Review Officer (MRO) and MRO staff are located on site at the facility of a licensee or
other entity, the MRO and MRO staff are also subject to behavioral observation. Section
26.189(c) accounts for the burden of records generated under the BOP.
10 CFR 26.31(c) requires licensees and other entities to implement D&A testing programs that
administer tests under five conditions. No records are required by this section, but are required
under Subparts C – G, and N.
(1) Pre-access (to grant initial, updated, or reinstated authorization to an individual)
(2) For cause (in response to an individual’s observed behavior or physical condition
indicating possible substance abuse, or after receiving credible information of
substance abuse)
(3) Post-event (after an event involving human error that may have caused or contributed
to the event)
(4) Follow-up (as part of a follow-up plan to verify continued abstinence of substance
abuse)
(5) Random (on a statistically random and unannounced basis such that all individuals in
the population subject to testing have an equal probability of being selected and tested)
10 CFR 26.31(d)(1)(i)(C) permits a licensee or other entity to test for additional substances not
included in the NRC-required testing panel. To do so, the substance(s) must be listed in
Schedules I through V of Section 202 of the Controlled Substances Act [21 U.S.C. 812] and the
licensee or other entity must establish rigorous testing procedures so that the MRO can
evaluate the use of these substances. The development of rigorous testing procedures ensures
to the accuracy of test results and is a donor protection. The burden for this activity is accounted
for under Section 26.27.
10 CFR 26.31(d)(1)(i)(D) permits a licensee or other entity to test for a drug or drug metabolite
not listed in Section 26.31, if the assay and cutoff levels to be used are certified in writing as
scientifically sound and legally defensible by an independent qualified forensic toxicologist who
has no relationships with manufacturers of the assays or instruments to be used or the HHS
Certified Laboratory that will conduct the testing for the licensee or other entity, which could be
construed as a potential conflict of interest. Certification is not required if the U.S. Department of
Health and Human Services’ (HHS) Mandatory Guidelines for Federal Workplace Drug Testing
Programs (HHS Guidelines) are revised to authorize use of the assay in testing for the
additional drug or drug metabolites and the licensee or other entity uses the cutoff levels
established in the HHS Guidelines. This paragraph allows licensees and other entities to add to
the panel of drugs for which testing is required in Section 26.31(d)(1) and to assign cutoff levels
that shall be certified in writing as scientifically sound and legally defensible by an independent
11
forensic toxicologist. This requirement ensures that the NRC can verify that the assays and
cutoff levels are appropriate. The licensee or other entity is required to maintain a copy of each
certification under Section 26.31(d)(1)(i)(D). Recordkeeping requirements for
Section 26.31(d)(1)(i)(D) are established by Section 26.713(g).
10 CFR 26.31(d)(1)(ii) and (d)(1)(ii) permit licensees and other entities to test for additional
drugs beyond the minimum testing panel in Section 26.31(d)(1). These requirements detail the
process that a licensee or other entity must complete to verify that the assays and cutoff levels
used in testing are scientifically sound and legally defensible (i.e., independent forensic
toxicologist evaluation and written certification). The licensee or other entity is required to
maintain a copy of each certification under Section 26.31(d)(1)(ii). Recordkeeping requirements
for Section 26.31(d)(1)(ii) are established by Section 26.713(g).
•
10 CFR 26.31(d)(1)(ii) allows licensees and other entities that are conducting post-event,
follow-up, or for cause testing to test for any drugs listed on Schedules I through V of
Section 202 of the Controlled Substances Act [21 U.S.C. 812] that an individual is
suspected of having abused. If the drug(s) or drug metabolite(s) tested are not included
in the FFD program’s drug panel, the assay and cutoff levels to be used must be
certified in writing by an independent qualified forensic toxicologist in accordance with
Section 26.31(d)(1)(i)(D).
•
10 CFR 26.31(d)(1)(iii) requires licensees or other entities to document and describe the
additional drugs for which testing will be performed in written policies and procedures.
10 CFR 26.31(d)(3)(ii) describes the training and skills that LTF technicians must possess to
perform validity and drug testing of urine specimens and requires the retention of documentation
of these qualifications. These requirements ensure that LTF technicians perform drug and
validity tests correctly. The burden for documenting the qualifications of LTF personnel is
accounted for under Section 26.125(b) and (c).
10 CFR 26.31(d)(3)(iii)(A) and (d)(3)(iii)(C) ensure that individuals receive prior notice of the
cutoff levels that are used, and that those cutoff levels are certified by an appropriate expert as
meeting the criteria of scientific and technical suitability. The cutoff levels used in a licensee or
other entity's testing program are available to subject individuals through the FFD policy or
procedures developed pursuant to Section 26.27. The licensee or other entity must maintain a
copy of each certification under Section 26.31(d)(3)(iii)(C). Section 26.713 establishes the
recordkeeping requirements for Section 26.31(d)(3)(iii)(A) and (C).
•
10 CFR 26.31(d)(3)(iii)(A) requires a licensee or other entity that uses more stringent
cutoff levels than the cutoff levels specified in Section 26.163 to document the cutoff
levels in any written policies and procedures in which cutoff levels for drug testing are
described.
•
10 CFR 26.31(d)(3)(iii)(C) requires the scientific and technical suitability of more
stringent cutoff levels to be evaluated and certified, in writing, by a forensic toxicologist,
unless the HHS Guidelines are revised to lower the cutoff levels used for the drug or
drug metabolites in Federal workplace testing programs and the licensee or other entity
implements the cutoff levels published in the HHS Guidelines, or if the licensee or other
entity received written approval of the NRC to test for lower cutoff levels before the
implementation of the final rule.
12
10 CFR 26.33 requires all individuals subject to an FFD program be subject to behavioral
observation by trained personnel who can detect impairment from drugs, alcohol, fatigue or
other adverse behaviors and can notify specified personnel identified in the FFD policy to take
appropriate action. The burden for records of FFD concerns based on possible impairment from
drugs or alcohol is covered under Section 26.31(c)(2), which describes for-cause D&A testing
actions to be conducted when any observed behavior or credible information received indicates
possible substance abuse. The burden for records of FFD concerns related to fatigue is covered
under Section 26.211(a)(1), which describes the requirement to perform a fatigue assessment in
response to an observed condition of impaired alertness creating a reasonable suspicion that an
individual is not fit to safely and competently perform his or her duties. Records generated
pursuant to Section 26.33 are maintained as part of for-cause testing records under
Section 26.31 or fatigue assessment records under section 26.211.
10 CFR 26.35(a) requires each licensee and other entity to maintain an employee assistance
program (EAP) to offer confidential assessment, short term counseling, referral services, and
treatment monitoring to individuals who have problems that could adversely affect the
individuals’ abilities to safely and competently perform their duties. This requirement defines the
scope and activities of the EAP and provides assurance that personnel have access to
adequate treatment options for conditions that could result in conditions adverse to safety. A
written description of the EAP program is included in the FFD policy and procedures developed
under Section 26.27.
10 CFR 26.35(c) requires, in part, that EAP staff protect the privacy each individual seeking
assistance, which encourages use of the EAP. The EAP may release information to the licensee
or other entity if the individual waives the right to privacy in writing, or if a determination is made
that the individual's condition or actions pose or have posed an immediate hazard to himself or
herself or others. The EAP offers confidential assessment, short-term counseling, referral
services, and treatment monitoring to individuals who self-identify problems that could
potentially affect their ability to safely and competently perform assigned duties, and may also
include those who have violated the FFD and are receiving treatment for substance abuse. The
requirement that the individual waive the right to privacy in writing is a donor protection. The
requirement that the EAP staff informs the FFD program management if an individual poses or
has posed an immediate hazard to him or herself or others, is necessary to enable early
intervention to prevent self-harm, harm to others, a reportable occurrence, or condition adverse
to safety or security.
10 CFR 26.37(a), (b) and (b)(1), (c), and (d) ensure that personal information collected under
Part 26 is protected, and only disclosed to persons permitted to access such information under
Part 26 or specifically authorized by the donor through written consent.
•
10 CFR 26.37(a) requires each licensee or other entity that collects personal information
on an individual for the purpose of complying with Part 26, to establish, use, and
maintain a system of files and procedures to protect the individual’s privacy.
•
10 CFR 26.37(b) requires each licensee or other entity to obtain a signed consent from
an individual that authorizes the disclosure of personal information collected under
Part 26. No consent is needed if information sharing is authorized by Part 26 (e.g., MRO
and MRO staff; NRC representatives; law enforcement officials under court order;
licensee or other entity personnel with a need for access to perform assigned duties in
13
the FFD program; presiding officer in judicial or administrative proceeding initiated by the
individual).
•
10 CFR 26.37(b)(1) specifies that if an individual requests the licensee or other entity
disclose personal information collected under Part 26 to the individual’s designated
representative for specified FFD matters (e.g., a union official, attorney), the individual
must designate this request in writing. This collection is a donor protection that ensures
that personal information collected under Part 26 is not disclosed without the donor’s
permission, and also provides the licensee or other entity with documentation to
demonstrate evidence of receipt of this request.
•
10 CFR 26.37(c) requires that an FFD program disclose, after receiving a signed release
form a subject individual, information collected under Part 26 to other licensees or
entities making authorization decisions under Part 26. Section 26.713(a) establishes the
recordkeeping requirements for Section 26.37(c).
•
10 CFR 26.37(d) requires the FFD program (including the collection site, HHS lab,
Substance Abuse Expert (SAE), or MRO), after receiving a written request from a
subject individual or designated representative, to promptly provide copies of all FFD
records pertaining to the individual (e.g., records on the determination of an FFD policy
violation, D&A test results, MRO reviews, determinations of fitness, HHS lab
certification). This section is a donor protection by providing access to records created
under Part 26. Sections 26.713 and 26.715 establish the recordkeeping requirements for
Section 26.37(d).
10 CFR 26.39(a) and (b) ensure that a licensee or other entity establish procedures for the
determination of FFD policy violations, notification of those determinations to subject individuals,
and afford individuals with an objective and impartial review of such determinations, if
requested. These requirements afford due process to individuals subject to the rule by providing
specific information on the FFD policy violation, and the procedures to follow if a review of that
determination is sought. Section 26.715(a) establishes the recordkeeping requirements for
sections 26.39(a) and (b)
•
10 CFR 26.39(a) requires each licensee and other entity subject to Subpart B to
establish procedures for the review of a determination that an individual has violated the
FFD policy.
•
10 CFR 26.39(b) requires that the procedures for the review of a determination that an
individual has violated FFD policy provide for giving notice to the individual of the
grounds for the determination that the individual has violated the FFD policy and provide
for an opportunity for the individual to respond and submit additional information.
10 CFR 26.39(d) requires that if a review of a determination that an individual has violated FFD
policy finds in favor of the individual, the licensee or other entity must update the relevant
records to delete or correct all information found to be inaccurate. This requirement is a donor
protection and ensure that a licensee’s and other entity’s records do not contain incorrect
information concerning FFD determinations. Section 26.713(a)(2) establishes the recordkeeping
requirements for section 26.39(d).
14
10 CFR 26.39(e) requires that when a C/V is administering an FFD program on which licensees
and other entities rely, and the C/V determines that its employee, subcontractor, or applicant
has violated the FFD policy, the C/V provides the individual with the review procedure required
by Section 26.39(b). This requirement affords due process by ensuring that each individual with
an FFD policy violation is provided specific information on the FFD policy violation
determination, and the procedures to follow if a review of that determination is sought.
Section 26.713(a)(2) establishes the recordkeeping requirements for Section 26.39(e).
10 CFR 26.41(a), (b), (c)(1), (d), (f), and (g) specify the licensee and other entity auditing
requirements, including audit documentation, records maintenance, and records access. These
requirements ensure that a licensee or other entity documents oversight of C/Vs and service
providers. These records would be evaluated during NRC inspections. Section 26.713(b)(2)
establishes the recordkeeping requirements for retaining audit records.
•
10 CFR 26.41(a) requires licensees and other entities to audit the FFD program
elements provided by any C/V, the FFD program of any C/V accepted by the licensee or
other entity, any FFD program service provided to the C/V by a subcontractor, and any
HHS lab used by the licensee or other entity and its C/Vs. This section also requires that
corrective actions be taken for any problems identified during an audit. License or other
entity audits of service providers and C/Vs ensure to the continuing effectiveness of the
FFD program.
•
10 CFR 26.41(b) requires that licensees and other entities audit the entire FFD program
on a nominal 24-month frequency, or sooner if needed.
•
10 CFR 26.41(c)(1) requires that licensees and other entities to audit on a nominal 12month frequency the FFD services provided to a licensee or other entity by C/V
personnel who are off site or are not under the direct daily supervision or observation of
the licensee’s or other entity’s personnel, and HHS labs.
•
10 CFR 26.41(d) requires that a licensee’s or other entity’s contract with a C/V or HHS
lab include two records access provisions. The right to access and review information
that is reasonably relevant to audits of FFD program elements provided by C/Vs, the
program elements of any C/Vs accepted by the licensee or other entity, and the HHS
lab. The right to obtain and take away copies any documents and data that may be
needed to assure that the C/V, its subcontractors, or the HHS lab properly perform
functions.
•
10 CFR 26.41(f) requires the results of any audits required by Section 26.41(a), (b), and
(c) to be documented and reported to senior corporate and site management. C/Vs who
have licensee-approved FFD programs must provide the licensees to whom they provide
services with copies of the audit report.
•
10 CFR 26.41(g) allows licensees and other entities to jointly conduct audits or to accept
audits conducted by other licensees, but requires them to review audit records and
reports to identify any areas that were not covered by the shared or accepted audit and
to maintain a copy of the shared audit and inspection records, including findings,
recommendations, and corrective actions.
15
10 CFR 26.53(e)(2) requires a C/V to inform a licensee or other entity if the C/V’s FFD program
denies or unfavorably terminates an individual’s authorization and the individual is performing
any duties for the licensee or other entity that are specified in Section 26.4(a) through (e)
and (g), or, at the licensee’s or other entity’s discretion, Section 26.4(f). The licensee or other
entity is required to deny or unfavorably terminate the individual’s authorization to perform those
duties on the day that it receives information from the C/V, or to implement the process in
Section 26.69 to maintain the individual’s authorization. This section requires communications
between the C/V and the licensee or other entity to ensure that the necessary information is
transferred between them concerning the individual.
10 CFR 26.53(g) requires the licensee and C/V personnel specified in Section 26.4(a) and, as
applicable, Section 26.(4)(d) to identify any violation of any requirement of Part 26 to any
licensee who has relied on or intends to rely on the FFD program element that is determined to
be in violation of Part 26. This section requires communications between the C/V and the
licensee or other entity to ensure that the necessary information is transferred between them
concerning the violation.
10 CFR 26.53(h) requires licensees and other entities to obtain the knowledge and written
consent of the subject individual before initiating any actions under Subpart C, Granting and
Maintaining Authorization. The licensee or other entity is required to record the individual’s
application for authorization; withdrawal of consent; the reason given for the withdrawal, if any;
and any pertinent information gathered from the elements that were completed. Actions relating
to authorization become part of a record that can affect the individual’s ability to be employed in
the nuclear power industry. An individual’s consent to actions is necessary to protect the person
from actions taken without their knowledge or approval.
10 CFR 26.53(i) requires licensees and other entities to inform, in writing, any individual who is
applying for authorization that the following actions are sufficient cause for denial or unfavorable
termination of authorization: refusal to provide written consent for the suitable inquiry; refusal to
provide or falsification of any personal information required under Subpart C of Part 26; refusal
to provide written consent for the sharing of personal information with other licensees or C/Vs;
and failure to report any legal actions, as defined by Section 26.5. This section requires the
licensee or other entity to provide a written notice to the individual of the actions that are
sufficient cause for denial or unfavorable termination. This notice is necessary in advance to
allow individuals to determine whether the application process may lead to an unfavorable
record that could preclude their future employment in the nuclear power industry.
10 CFR 26.55(a)(1) and (a)(2) require that a self-disclosure (Section 26.61) and suitable inquiry
(Section 26.63) be completed by each applicant who has never held authorization or whose
authorization has been interrupted for more than 3 years. Information provided in the selfdisclosure, employment history, and suitable inquiry enables the licensee or other entity to make
an access determination (i.e., is the applicant trustworthy, reliable, and fit for duty).
Sections 26.61, 26.63, and 26.713(a)(1) and (3) establish the recordkeeping requirements for
Section 26.55(a)(1) and (a)(2).
•
10 CFR 26.55(a)(1) requires the licensee or other entity to obtain and review a selfdisclosure and employment history from an individual before granting authorization to
the individual.
•
10 CFR 26.55(a)(2) requires the licensee or other entity to complete a suitable inquiry
before granting authorization to the individual.
16
10 CFR 26.57(a)(1) and (a)(2) require that a self-disclosure (Section 26.61) and suitable inquiry
(Section 26.63) be completed by each applicant who is applying for authorization after an
interruption of more than 365 days but less than 3 years, and whose last period of authorization
was terminated favorably. Information provided in the self-disclosure, employment history, and
suitable inquiry enables the licensee or other entity to make an access determination (i.e., is the
applicant trustworthy, reliable, and fit for duty). Sections 26.61, 26.63, and 26.713(a)(1)
and (a)(3) establish the recordkeeping requirements for Section 26.57(a)(1) and (a)(2).
•
10 CFR 26.57(a)(1) requires the licensee or other entity to obtain and review a selfdisclosure and employment history from an individual before granting authorization to
the individual.
•
10 CFR 26.57(a)(2) requires the licensee or other entity to complete a suitable inquiry
before granting authorization to the individual.
10 CFR 26.59(a)(1) and (a)(2) require that a self-disclosure (Section 26.61) and suitable inquiry
(Section 26.63) be completed by each applicant who is applying for authorization after an
interruption of more than 30 days but no more than 365 days, and whose last period of
authorization was terminated favorably. Information provided in the self-disclosure, employment
history, and suitable inquiry enables the licensee or other entity to make an access
determination (i.e., is the applicant trustworthy, reliable, and fit for duty). Sections 26.61, 26.63,
and 26.713(a)(1) and (a)(3) establish the recordkeeping requirements for Section 26.59(a)(1)
and (a)(2).
•
10 CFR 26.59(a)(1) requires the licensee or other entity to obtain and review a selfdisclosure and employment history from an individual before granting authorization to
the individual.
•
10 CFR 26.59(a)(2) requires the licensee or other entity to complete a suitable inquiry
before granting authorization to the individual.
10 CFR 26.59(c)(1) requires the licensee or other entity to obtain and review a self-disclosure
from an individual whose authorization has been interrupted for a period of no more than
30 days and whose last period of authorization was terminated favorably before granting
authorization to the individual. In this instance, because authorization was interrupted for a short
time period (30 days or less), a suitable inquiry would not be completed. The self-disclosure
information enables the licensee or other entity to provide reasonable assurance that an
individual is trustworthy, reliable, and fit for duty, as demonstrated by avoiding substance abuse,
and information on the individual’s character and reputation covered in the self-disclosure.
Information provided in the self-disclosure enables the licensee or other entity to make an
access determination (i.e., is the applicant trustworthy, reliable, and fit for duty). Sections 26.61,
and 26.713(a)(1) and (a)(3) establish the recordkeeping requirements for Section 26.59(c)(1).
10 CFR 26.61(a), (a)(1) and (a)(2) specify when a self-disclosure and employment history must
be completed for an individual seeking authorization. The burdens for an applicant to complete
and review a self-disclosure and an employment history, and the licensee or other entity to
review this information are accounted for under Section 26.61(a). Paragraph 26.61(a)(1) and
(a)(2) relax the self-disclosure and employment history reporting requirements in sections 26.55,
17
26.57, and 26.59. Section 26.713(a)(1) establishes the recordkeeping requirements for
section 26.61(a).
•
10 CFR 26.61(a) requires a licensee or other entity to obtain a written self-disclosure
and employment history from an individual who is applying for authorization, except
under two circumstances described in Section 26.61(a)(1) and (a)(2).
•
10 CFR 26.61(a)(1) specifies that a self-disclosure and employment history are not
needed, if the individual previously held authorization under Part 26, the licensee or
other entity verifies the individual’s last authorization was terminated favorably, and the
individual was subject to a behavioral observation and an arrest-reporting program
throughout the time since the last authorization.
•
10 CFR 26.61(a)(2) specifies that the individual’s last period of authorization was
terminated favorably within the past 30 days, the licensee or other entity need not obtain
the individual’s employment history.
10 CFR 26.61(b) and (c) specify the information to be collected in the self-disclosure and
employment history from an applicant and ensures that necessary information on
trustworthiness, reliability, and fitness for duty is available to support a licensee’s or other
entity’s authorization determination under sections 26.55, 26.57, or 26.59. The burden for this
information collection is accounted for under Section 26.61(a), (a)(1), and (a)(2).
•
10 CFR 26.61(b) specifies the information to be included in the written self-disclosure,
and includes information on FFD policy violations; authorization denials; unfavorable
terminations of authorization; use, sale, or possession of illegal drugs; abuse of legal
drugs or alcohol; subversion or attempted subversion of a drug or alcohol testing
program; refusal to take a drug or alcohol test; substance abuse treatment (except for
self-referral); and, legal or employment action taken for alcohol or drug use.
•
10 CFR 26.61(c) requires the individual to provide an employment history listing
employers and dates of employment.
10 CFR 26.63(a), (b), (c) and (c)(2), and (f) describe information to be reported or recorded in
support of authorization determinations under sections 26.55, 26.57, and 26.59, and also
describe limitations on use of this information. Paragraphs 26.63(b), (c), and (f) specify that
licensees and other entities may rely on third-party communications, but do not create any
additional recordkeeping requirements. Paragraph 26.63(c)(2) creates an additional information
collect if an applicant’s employment history included military service. Section 26.713(a)(1)
establishes the recordkeeping requirements for Section 26.63(a) and (c)(2).
•
10 CFR 26.63(a) requires the licensees or other entities to ensure a suitable inquiry has
been conducted unless the individual was previously authorized, the licensee has
verified that the last authorization was terminated favorably, and the individual was
subject to a behavioral observation and arrest-reporting program throughout the period
of interruption.
•
10 CFR 26.63(b), (c), and (f) specify that for the suitable inquiry requirement, a licensee
or other entity may rely upon information gathered by other entities subject to Subpart C
of Part 26 regarding an applicant’s previous period(s) of authorization (e.g., reasons for
18
termination, eligibility for rehire, determinations of fitness conducted under
Section 26.189, reviews and resolutions of PDI).
•
10 CFR 26.63(c)(2) specifies that if an applicant employment history includes military
service, the licensee or other entity must request a characterization of service, reason
for separation, and any disciplinary actions related to PDI. If the applicant’s last duty post
cannot provide this information, a copy of the DD 214 from the custodian of military
records or from the applicant is acceptable.
10 CFR 26.63(c)(3) specifies that if a company, previous employer, or educational institution to
whom the licensee or other entity has directed a request for information refuses to provide
information within 3 business days of the request, the licensee or other entity shall document
this refusal, inability, or unwillingness in the record of the investigation and obtain a confirmation
of employment or educational enrollment and attendance from at least one alternate source. If
the licensee or other entity uses an alternate source but the response is received after
3 business days, the response should be evaluated and documented. This requirement ensures
that a record is created that documents any gaps or absences in the information otherwise
required by sections 26.55, 26.57, and 26.59. This requirement also helps to ensure that
licensees and other entities can grant authorization, even if the information requested but not
received from another company, previous employer, or educational institution, is not available.
Recordkeeping requirements for Section 26.63(c)(3) are established by Section 26.713(a)(1).
10 CFR 26.63(d) requires, if a licensee or other entity presents to another licensee or other
entity an individual’s signed release authorizing the disclosure of information, that other licensee
or entity shall disclose whether the individual’s authorization was denied or terminated
unfavorably as a result of a violation of an FFD policy and the information upon which the denial
or unfavorable termination of authorization was based and any other information that is relevant
to an authorization decision. This requirement ensures that information about individuals can be
transferred from one licensee or other entity to another licensee or other entity for FFD
determinations, because individuals who belong to the much more transient workforce that is
currently employed in the nuclear industry frequently move from one licensee or other entity to
another. Sections 26.711 and 26.713(a), (b), and (c) establish the recordkeeping requirements
in Section 26.63(d)
10 CFR 26.63(e) specifies that the licensee or other entity may obtain, when verifying
information provided by an applicant in a suitable inquiry, information and documents by
electronic means (including but not limited to telephone, facsimile, or email). The licensee or
other entity shall document information obtained by telephone, and retain any records,
documents, and files obtained, as required by sections 26.711 and 26.713(a),(b), and (c).
10 CFR 26.63(f) specifies the time periods that a suitable inquiry must cover for initial
authorization, authorization update, and authorization reinstatement after an interruption of more
than 30 days. While this section does not contain an information collection, it specifies when
information is to be collected under Section 26.63(a), (c) and (e).
10 CFR 26.65(d)(1) and (e)(2) provide that a licensee or other entity may reinstate authorization
for an individual whose authorization has been interrupted for more than 30 days but less than
365 days, or for less than 30 days, respectively, if the individual has negative results from
alcohol testing and a specimen for drug testing is collected before authorization is reinstated.
Section 26.713(a)(3) establishes the recordkeeping responsibilities for sections 26.65(d)(1) and
26.65(e)(2).
19
10 CFR 26.65(d)(1)(ii) and (e)(2)(iii)(B) specify that if a licensee or other entity does not receive
negative drug test results within 5 business days of specimen collection for an individual
seeking authorization reinstatement after an interruption of more than 30 days, authorization
must be administratively withdrawn until the test results are received.
10 CFR 26.65(f) specifies that if a licensee or other entity administratively withdraws an
individual’s authorization under paragraphs (d)(1)(ii) or (e)(2)(iii)(B), and until the drug results
are known, the licensee or other entity may not record the administrative action to withdraw
authorization as an unfavorable termination. Immediately upon receipt of negative test results,
the licensee or other entity shall ensure that any matter that could link the individual to the
temporary administrative action is eliminated from the donor’s personnel record and other
records. This requirement ensures that the personnel records for each individual only contain
accurate information. Section 26.713(a)(2) establishes the recordkeeping requirements for
Section 26.65(f).
10 CFR 26.67(a), (b), and (c) specifies that an individual must be subject to random testing if
the individual has applied for authorization under sections 26.65 or 26.29, has been pre-access
tested, but has yet to be granted authorization. Section 26.713(a)(2) and (a)(3) establishes the
recordkeeping requirements of Section 26.67.
•
10 CFR 26.67(a) specifies that an individual that has applied for authorization shall be
subject to random testing under Section 26.31(d)(2), except if authorization has not been
granted, or the licensee or other entity relies on D&A tests that were conducted before
the individual applied for authorization (in which case the individual would be subject to
random testing upon arrival at the licensee or other entity’s facility for inprocessing and
thereafter).
•
10 CFR 26.67(b) provides that if an individual is selected for one or more random tests
after completing pre-access testing under sections 26.65 or 26.69, the licensee may
grant authorization before the random testing is completed.
•
10 CFR 26.67(c) provides that if an individual has a confirmed positive, adulterated, or
substituted test result from any drug, validity, or alcohol test required under this
paragraph, the licensee or other entity may deny authorization, terminate the individual’s
authorization if already granted, or grant authorization to the individual under
Section 26.69.
10 CFR 26.69(b), (c)(1) – (c)(5), (d), and (e) and (e)(1) specify the information upon which a
licensee or other entity is to base an authorization decision on when evaluating individuals that
have disclosed PDI (i.e., FFD policy violation for a first or second drug or alcohol positive, a
violation of FFD policy not based on D&A testing). Section 26.713(a)(1) establishes the
recordkeeping requirements for sections 26.69(b), (c)(1), (c)(2) and (c)(3); and
Section 26.713(a)(3) establishes the recordkeeping requirements for sections 26.69(c)(4) and
(c)(5), and 26.69(d).
•
10 CFR 26.69(b) specifies that for an individual seeking authorization after a first or
second confirmed positive drug or alcohol test result, the licensee or other entity must:
(1) obtain and review a self-disclosure and employment history; (2) complete a suitable
inquiry with each employer that the individual claims to have been employed by during
20
the period addressed in the self-disclosure; and (3) obtain and review any records from
other Part 26 regulated entities developed on the individual related to unfavorable
termination or denial of authorization.
10 CFR 26.69(c)(1) requires the licensee or other entity to obtain and review a selfdisclosure and employment history for the past 5 years (for whichever time period is
shorter – since the individual’s 18th birthday, or since the individual’s last period of
authorization was terminated).
•
10 CFR 26.69(c)(2) requires the licensee or other entity to complete a suitable inquiry
with every employer listed in the applicant’s employment history. If the individual held
authorization within the past 5 years, the licensee or other entity also must obtain and
review any records that other Part 26 regulated entities developed regarding PDI
obtained within the past 5 years.
•
10 CFR 26.69(c)(3) requires, where PDI is discovered that is not a first or second
confirmed positive drug or alcohol test, that the licensee or other entity verify that a
professional qualified under Section 26.187(a) has determined that the individual is fit for
duty.
•
10 CFR 26.69(c)(4) requires the licensee or other entity to ensure the individual is in
compliance with, or has completed, plans for treatment and D&A testing from the
determination of fitness.
•
10 CFR 26.69(c)(5) requires the licensee to verify that results of pre-access D&A testing
are negative before granting authorization, and that the individual then is subject to
random testing.
•
10 CFR 26.69(d) provides that if an individual is authorized when other PDI is disclosed
or discovered, in order to maintain the individual’s authorization the licensee or other
entity shall ensure that a reviewing official completes a review of the circumstances
associated with the PDI; decide whether a determination of fitness is required; verify that
if a determination of fitness is required that a professional with the appropriate
qualifications has indicated that the individual is fit to safely and competently perform his
or her duties; and implement any recommendations for treatment and follow-up D&A
testing from the determination of fitness.
•
10 CFR 26.69(e) allows licensees and other entities to rely on follow-up testing,
treatment plans, and determinations of fitness that were completed by the FFD program
of another licensee or other entity under 26.189.
•
10 CFR 26.69(e)(1) requires licensees or other entities that administered treatment
and/or follow-up testing for an individual to ensure that information documenting the
treatment and/or follow-up plan is identified to any subsequent licensee or other entity
who seeks to grant authorization to the individual.
10 CFR 26.75(a) – (e), and (g) specify the minimum sanctions that licensees and other entities
must impose for violations of the FFD policy (e.g., a first positive drug test result, attempting to
subvert a test, possession of illegal drugs or consumption of alcohol on site). The licensee or
other entity must maintain a record of the sanction imposed on each individual, which is
21
necessary in case the individual applies for authorization at a later date (at the same or another
facility subject to Part 26). Section 26.713(c) establishes the recordkeeping requirements for
Section 26.75(a) – (e) and g.
10 CFR 26.75(h) specifies that a licensee or other entity performing initial drug and validity
testing of specimens at an LTF may not terminate an individual’s authorization or subject an
individual to other administrative action based solely on a positive initial drug test, except if the
test is positive for marijuana or cocaine metabolites. This provision does not prohibit a licensee
from taking additional action if other evidence indicates the individual is impaired or might
otherwise pose a safety hazard. This requirement does not create any reporting or
recordkeeping requirements; however, it initiates the requirements in sections 26.75(i).
10 CFR 26.75(i) and (i)(3) ensure that any administrative action to withdraw authorization is not
permanently recorded as an unfavorable termination of the individual, or communicated to
another licensee or other entity as an unfavorable termination, unless and until such a record
and such communication is correct and appropriate. The recordkeeping requirements for these
requirements are established by Section 26.713(a)(2).
•
10 CFR 26.75(i) allows an LTF to inform the licensee or entity of a positive initial drug
test result for marijuana or cocaine metabolite and for the licensee or other entity to
administratively withdraw an individual’s authorization (or take lesser administrative
action against the individual), provided that certain conditions specified in
Section 26.75(i)(1) – (i)(4) are met.
•
10 CFR 26.75(i)(3) requires that a licensee or other entity immediately eliminate any
matter from an individual’s personnel files that could link that individual to the temporary
administrative action taken in response to an initial positive drug test result from an LTF
for marijuana or cocaine metabolite that confirmed negative after additional testing at an
HHS lab.
10 CFR 26.75(i)(4) requires, in part, that licensees and other entities may not disclose the
temporary administrative action against an individual whose initial drug test result is not
subsequently confirmed by the MRO as a violation of FFD policy in response to a suitable
inquiry conducted under Section 26.63, a background investigation conducted under Part 26, or
to any other inquiry or investigation. The licensees or other entities must provide access to the
system of files and records to personnel who are conducting reviews, inquiries into allegations,
audits conducted pursuant to Section 26.41, and to NRC inspectors, to enable reviews and to
verify the adequacy of record requirements (for this case, to verify that the record was not
retained). The licensees or other entities shall provide the tested individual with a written
statement that the records specified in sections 26.713 and 26.715 have not been retained, and
shall inform the individual in writing that the temporary administrative action that was taken will
not be disclosed and need not be disclosed by the individual in response to requests for selfdisclosure of PDI. These requirements ensure that any administrative action to withdraw
authorization is not permanently recorded as an unfavorable termination of the individual, or
communicated to another licensee or other entity as an unfavorable termination, unless and
until such a record and such communication is correct and appropriate. This also ensures that
an individual, the individual’s personal representatives, and the NRC are allowed to review the
records to ensure that no inappropriate records are retained, and that a written confirmation that
the temporary administrative action will not be disclosed, and that the individual need not
disclose the action, is provided to the individual. The recordkeeping requirements for this
paragraph are established by Section 26.713(a)(2).
22
10 CFR 26.77(c) requires a licensee or other entity that has a reasonable belief that an NRC
employee or NRC contractor may be under the influence of any substance, or is otherwise unfit
for duty, including when the observed behavior or physical condition is solely the result of
fatigue, must immediately notify the appropriate Regional Administrator by telephone, followed
by written notification to document the verbal notification, or, if the Regional Administrator
cannot be reached, to notify the NRC Operations Center. This requirement ensures that the
NRC receives immediate notification by telephone, followed by written notification, that an NRC
employee or NRC contractor may be under the influence of a substance or is otherwise unfit for
duty, so that the NRC can take action to remove the employee from duty and to take any other
appropriate actions. Reporting requirements for Section 26.77(c) are established by
Section 26.719(a).
10 CFR 26.85(a) and (b) ensure that individuals performing specimen collections under Part 26
received appropriate training to complete the collection process consistent with the
requirements in Subpart E of Part 26. Section 26.715(a) and (b)(1) establishes the
recordkeeping requirements for Section 26.85(a) and (b).
•
10 CFR 26.85(a) requires qualification training for urine collectors on the requirements of
Part 26, the FFD policy and procedures of the licensee or other entity for whom
collections are performed, all steps necessary to complete a collection correctly and the
proper completion and transmission of the custody-and-control form (CCF); methods to
address problem collections, how to correct problems in collections, and the collector’s
responsibility for maintaining the integrity of the specimen collection and transfer
process, ensuring the modesty and privacy of the donor, and avoiding conduct or
remarks that might be construed as accusatorial or otherwise offensive or inappropriate.
•
10 CFR 26.85(b) requires qualification training for alcohol collectors on the requirements
of Part 26, the FFD policy and procedures of the licensee or other entity for whom
collections are performed, and any changes to alcohol collection procedures, the alcohol
testing requirements of Part 26, operation of the particular alcohol testing device(s) or
evidential breath testing devices (EBTs) to be used, consistent with the most recent
version of the manufacturer’s instructions, methods to address problem collections, how
to correct problems in collections, and the collector’s responsibility for maintaining the
integrity of the specimen collection and transfer process, ensuring the modesty and
privacy of the donor, and avoiding conduct or remarks that might be construed as
accusatorial or otherwise offensive or inappropriate.
10 CFR 26.85(c)(5) requires that an alternative collector that does not meet the training criteria
in Part 26 be provided with detailed, clearly-illustrated, written instructions for collecting
specimens in accordance with Subpart E. This information ensures that an alternative collector
is able to perform a collection consistent with Part 26 requirements and also is a donor
protection. Section 26.715(a) establishes the recordkeeping requirements for
Section 26.85(c)(4).
10 CFR 26.85(e) describes the types of records to be included in the personnel file of a
specimen collector (e.g., job description, resume, references, certifications or licenses,
references, performance evaluations, incident reports, results of competency tests, any PDI
from background investigations performed under Section 23.31(b). This requirement is
necessary to provide assurance that the education, training, and competency of these
personnel are adequate to correctly understand processes and procedures, and can use the
23
instruments and devices necessary to implement specimen collection and analysis. This
assurance is vital for the determinations of fitness. In addition, records of training and
competency are important evidence in any litigation that may occur with respect to test results.
Sections 26.715(a) and (b)(1) establish the recordkeeping requirements for Section 26.85(e) are
established by.
10 CFR 26.87(d)(3) and (f)(1) ensure that collection sites are clearly identified to prevent
unauthorized access hat could compromise the integrity of the collection process and privacy of
the donor.
•
10 CFR 26.87(d)(3) specifies that if a collection site cannot be dedicated solely to
collecting specimens, the portion of the facility that is used for specimen collection must
be secured and, during the time period during which a specimen is being collected, a
sign must be posted to indicate that access is allowed only for authorized personnel.
•
10 CFR 26.87(f)(1) requires that in the exceptional event when a designated collection
site is inaccessible and a specimen must be immediately collected (e.g., an event
investigation), that a sign be posted or an individual assigned to ensure that no
unauthorized personnel are present during the collection procedure (this requirement
applies if a public restroom is used).
10 CFR 26.87(f)(3) – (f)(5) ensure that in the exceptional event that a designated collection site
is inaccessible and there is an immediate requirement to collect a urine specimen, that a chainof-custody form (CCF) is prepared that accurately identifies the origin of the specimen and links
that specimen to the donor. The information collection requirements also protect the donor.
Recordkeeping requirements for Section 26.87(f)(3) and (f)(5) are established by
Section 26.715(b)(2).
•
10 CFR 26.87(f)(3) requires that if a same gender collector is not available to
accompany the donor into the specimen collection area, then the collector must select a
same-gender person to accompany the donor, provide instruction on the collection
procedures to that person, and the collector must document the identity of the person on
the CCF.
•
10 CFR 26.87(f)(4) requires that after the collector has possession of the specimen, that
he or she instruct the donor to participate in completing the remaining steps in chain-ofcustody procedures.
•
10 CFR 26.87(f)(5) requires that the authorized collector maintain control of the
specimen until the specimen is prepared for transfer, storage, or shipping, and to
document his or her custody of the specimen on the CCF.
10 CFR 26.89(a), (b)(1) – (b)(4), and (c) specify specimen collection procedures to follow and
communications to complete based on specific circumstances that may arise during a collection.
For example, paragraph 26.89(b)(4) requires the collector to explain of the collection procedure
and obtaining a signed consent-to-test form, which is a donor protection and ensures to the due
process rights of the individual. Paragraph 26.89(c) requires the collector to inform the donor
that he or she must remain present until the collection is complete, and ensures that the donor
is aware of the consequences of leaving before the process is complete. Notice to FFD program
management if the donor leaves or is uncooperative ensures that appropriate actions are
24
undertaken under the FFD procedures. Section 26.715(b)(6) establishes the recordkeeping
requirements for Section 26.89(a), (b), and (c).
•
10 CFR 26.89(a) requires collectors to inform FFD program managers when an
individual fails to appear for drug testing.
•
10 CFR 26.89(b)(1) and (b)(2) requires, in part, that individuals show proper
identification before testing, and, if they cannot produce acceptable identification the
collector must notify FFD program management.
•
10 CFR 26.89(b)(3) provides that if the donor is scheduled for pre-access testing and
cannot produce acceptable identification, the collector may not proceed with the
collection and shall inform FFD program management that the individual did not present
acceptable identification.
•
10 CFR 26.89(b)(4) requires the collector to explain the testing procedure to the donor,
show the donor the form(s) to be used, and ask the donor to sign a consent-to-testing
form.
•
10 CFR 26.89(c) requires that the collector inform the donor that the donor must remain
present at the collection site until the collection is complete. In the event the donor
leaves the test site prematurely, the collector is required to report this to FFD
management.
10 CFR 26.91(c)(1), (c)(2), and (c)(3) specifies that an EBT device may be used for initial
testing for alcohol, and must be used for confirmatory testing, and specify the contents of each
printed test result (i.e., time of the test, a unique number is assigned and printed on the result
along with the manufacturer’s device name and serial number). This requirement establishes
the specifications of EBT devices to be used for alcohol testing and ensures that the results
provided by EBT devices can be attributable to the tested individual and the equipment used for
testing. This requirement helps to ensure that adequate information is available for reviews
necessary for a determination of fitness and in the conduct of legal proceedings, if any. This
requirement also helps to ensure that information is available with which to track the
performance (e.g., instrument calibration and linearity) of each EBT. This requirement does not
directly create any records, but describes the types of records that must be created through the
use of EBTs in FFD programs. Recordkeeping requirements for the records created using EBTs
that meet the specifications of Section 26.91(c)(1)-(3) are established by Section 26.715(b)(12).
10 CFR 26.91(e)(4) requires, in part, that each licensee or other entity use a calibrated EBT to
performed confirmatory alcohol testing. The licensee or other entity can verify that an EBT is
calibrated by following one of two procedures. Conduct an external check of calibration of the
EBT in the presence of the donor after every confirmed positive test result; or as specified by
the equipment manufacturer (e.g., after a specified number of tests are performed). If the later
process is followed and the EBT fails the external calibration check, the licensee or other entity
would have to cancel every confirmed positive test result that was obtained using that EBT from
the point after the EBT passed the last external calibration check. This process ensures to
accurate and reliable test results, and is a donor protection. Section 26.715(b)(14) establishes
the recordkeeping requirements for Section 26.91(e)(4).
25
10 CFR 26.91(e)(5) requires that the inspection, maintenance, and calibration of each EBT be
performed by the manufacturer or a certified representative of the manufacturer. This helps
ensure that each instrument is producing reliable, accurate, and repeatable results within
specified instrument parameters. Section 26.715(b)(14) establishes the recordkeeping
requirements for Section 26.91(e)(5).
10 CFR 26.91(e)(5) requires that records be maintained document the inspection, maintenance,
and calibration activities performed on EBTs. These records ensure that the licensee or other
entity and the NRC can perform oversight on alcohol testing activities. These records also are a
donor protection, ensuring to the accuracy of test results.
10 CFR 26.93(a)(6) requires that, prior to collecting a specimen for alcohol testing, the collector
must document that certain questions about substance ingested and instructions about the
testing process as specified in Section 26.93(a)(1)-(5) were communicated to the donor. This
requirement ensures that the donor understands how the test will be conducted and what the
donor must and must not do in order to ensure that the test result is valid and that the testing
process is not subverted. This requirement also partially meets the legal necessity of protecting
the due process rights of individuals who are subject to Part 26 and also proving prior notice
and having it documented for evidence in legal proceedings. Recordkeeping requirements for
Section 26.93(a)(6) are established by Section 26.715(b)(6).
10 CFR 26.95(b)(5) requires a collector conducting an initial breath test for alcohol to ensure
that the test result can be associated with the donor and is maintained secure. This requirement
is necessary to help ensure that the test result is an accurate and correct record with respect to
the individual who is being tested. This requirement also partially meets the legal necessity of
protecting the due process rights of individuals who are subject to Part 26 and also proving and
documenting prior notice for evidence in legal proceedings. Recordkeeping requirements for
Section 26.95(b)(5) are established by Section 26.715(b)(6).
10 CFR 26.97(b)(2) and (c)(1) ensures that if tests cannot be completed because the alcohol
testing device cannot be used correctly, that fact must be provided as an explanation of the
need for a new test. This helps to ensure that the need for a new test is not incorrectly attributed
to the actions of the individual donor. These requirements also partially meet the legal necessity
of protecting the due process rights of individuals who are subject to Part 26 and also proving
“prior notice“ and having it documented for evidence in legal proceedings. Recordkeeping
requirements for Section 26.97(b)(2) and (c)(1) are established by Section 26.715(b)(6).
•
10 CFR 26.97(b)(2) requires that, if the steps required to use the device correctly could
not be completed successfully, the collector must record the reason for a new test.
•
10 CFR 26.97(c)(1) requires that, if a second attempt at collection fails following the
failure of the initial attempt, the collector must document the reasons the collection could
not be completed.
10 CFR 26.97(d) requires the collector, when using a testing device, to show the device and its
reading to the donor, record the result, and record that an alcohol screening device (ASD) was
used. This requirement is necessary so that the donor can verify that a particular device was
used and confirm the result and the fact that the result was recorded correctly. This record is
important for due process rights of the tested individual and in the determination of fitness, if
any. The record of the use of the ASD and the result of the test also provide important
information for tracking the activities of the FFD program and helps ensure that information is
26
available for audits and NRC inspections. This requirement also partially meets the legal
necessity of proving and documenting prior notice for evidence in legal proceedings.
Section 26.715(b)(6) establishes the recordkeeping requirements for Section 26.97(d).
10 CFR 26.99(b) requires the collector to ensure that the time when an initial test whose result
is 0.02 percent blood alcohol concentration (BAC) or higher was concluded (i.e., the time at
which the test result was known) is recorded. This requirement ensures that the length of time
the donor had been in work status when the initial test was conducted can be determined, in
order to calculate the actual level while the individual was in work status, which is one factor
under Section 26.103 in determining whether to declare a confirmed positive test result. In
addition, by recording the time of the initial test, the FFD program can demonstrate that the 15minute waiting period required by Section 26.93(a), if necessary, has occurred before the initial
alcohol test was done. This requirement is also necessary to ensure that the confirmatory test is
done, as required by Section 26.101, no more than 30 minutes after the conclusion of the initial
test. Section 26.715(b)(6) establishes the recordkeeping requirements for Section 26.99(b).
10 CFR 26.101(b)(7) requires the collector to show the donor the result displayed upon or
printed by the EBT, record the result, and document the time at which the confirmatory test
result was known. This requirement is necessary so that the donor can personally know that a
particular device was used for the confirmatory test, the indicated confirmatory test result, and
the fact that the confirmatory test result was recorded correctly. The record of the result of the
confirmatory test and the time at which the result was known also provide important information
for determining whether or not a confirmed positive test result for alcohol must be declared. This
requirement also provides important information for tracking the activities of the FFD program,
and helps ensure that information is available for audits and NRC inspections. This requirement
also partially meets the legal necessity of protecting the due process rights of individuals who
are subject to Part 26 and also proving prior notice and having it documented for evidence in
legal proceedings. Section 26.715(b)(6) establishes the recordkeeping requirements for
Section 26.101(b)(7).
10 CFR 26.103(b) requires the collector to declare test results as negative where the results
show BAC below 0.02 but at or above 0.01, if the donor has been in work status for 3 hours or
more. The collector informs FFD management, and the licensee or other entity prohibits the
donor from performing duties until a determination of fitness is made. This third party collection
requirement ensures that FFD management is notified so that appropriate actions, including a
determination of fitness, can be undertaken under the FFD procedures. Section 26.715(b)(6)
establishes the recordkeeping requirements for Section 26.103(b).
10 CFR 26.107(b) requires the collector to document on the CCF any conduct that clearly
indicates an attempt to tamper with a specimen. This requirement is an integral part of the
collection procedure and is essential to documenting the chain of custody for the specimens
collected. The subversion of a Part 26 drug test is a relatively infrequent occurrence, however, it
results in a burden on a licensee because the regulation requires the licensee to take certain
actions to afford due process to the individual and verify the validity of the collection.
Documentation is necessary to record any attempt to tamper with a specimen to support any
subsequent appeals or reviews. Section 26.715(b)(6) establishes the recordkeeping
requirements for Section 26.107(b).
10 CFR 26.109(b)(3) and (b)(4) ensure that the specimen collector notifies the FFD program
manager or MRO if a donor is unable to provide a urine specimen of sufficient quantity within
27
the allotted timeframe permitted by Part 26. This notification ensures that additional procedures
can be initiated by the licensee or other entity to address this collection event.
•
10 CFR 26.109(b)(3) requires that, if the donor has not provided a specimen of at least
30 mL within 3 hours of the first unsuccessful attempt to urinate the required volume of
fluid, the collector shall discontinue the collection and notify the FFD program manager
or MRO to initiate the evaluation procedures in Section 26.119.
•
10 CFR 26.109(b)(4) requires the collector to discard specimens less than 30 mL, unless
the collector has reason to believe that the donor had diluted, adulterated, substituted, or
otherwise tampered with the specimen. In that event, if the sample is greater than 15 mL
and less than 30 mL, the collector is required to prepare the specimen for shipping to the
HHS-certified lab and contact FFD management to determine whether a directly
observed collection is required. Section 26.715(b)(6) establishes the recordkeeping
requirements for Section 26.109(b)(4)
10 CFR 26.111(b) requires the collector to inspect the urine specimen and to note any unusual
findings on the CCF. This requirement is an integral part of the collection procedure and is
essential to documenting the chain of custody for the specimens collected. Because this is
expected to be an infrequent occurrence, it does not create a significant additional burden.
However, the information provided could be useful to the laboratory conducting testing and
ensures the scientific supportability of the test results in case of a review in support of a
determination of fitness or legal proceedings. Recordkeeping requirements for
Section 26.111(b) are established by Section 26.715(b)(2).
10 CFR 26.111(c) requires the collector to contact the designated FFD manager if there is a
reasonable belief, based on observation, that the donor may have attempted to subvert the
testing process through specimen dilution, substitution, or adulteration. The FFD manager may
require the donor to provide a second specimen under direct observation. This requirement
ensures that the FFD program manager is informed of the possibility that a donor may have
attempted to subvert the testing process and to receive direction regarding appropriate
management actions to take. Recordkeeping requirements for Section 26.111(c) are
established by Section 26.715(b)(6).
10 CFR 26.113(b)(3) requires the collector to prepare a CCF for both specimens when the urine
specimen is split into two specimen bottles. This requirement is an integral part of the collection
procedure and is essential to documenting the chain of custody for the specimens collected.
Chain of custody, in turn, is a fundamental procedure for sample analysis, because it provides
an equivalently-obtained sample for testing and ensures that there is a record demonstrating
that the specimens analyzed by the laboratory are the same specimens that were obtained from
the donor. When the sample is split into two specimen bottles, a chain-of-custody form must be
prepared to accompany each bottle to properly identify each testing result. Recordkeeping
requirements for Section 26.113(b)(3) are established by Section 26.715(b)(2).
10 CFR 26.115(b) requires that, before collecting a urine specimen under direct observation, the
collector must obtain the agreement of the FFD program manager or MRO. This requirement is
necessary because of the intrusive nature of collecting a urine specimen under direct
observation. Therefore, a person qualified in making the determination that direct collection
must be used must make that decision; this determination must be documented. Recordkeeping
requirements for Section 26.115(b) are established by Section 26.715(a).
28
10 CFR 26.115(d) requires the collector to complete a new CCF for a specimen obtained from a
directly observed collection, and to record on the form that the collection was observed and the
reason(s) for the observed collection. This requirement ensures that the FFD program manager
or MRO is informed of the need for a collection under direct observation, so that the FFD
program manager or MRO can examine the circumstances and approve or deny the request for
a collection under direct observation; the FFD program manager or MRO, not the collector, are
qualified and assigned the responsibility of making the determination. The requirement to
complete a new CCF, and record the basis for the collection, is an integral part of the collection
procedure and is essential to documenting circumstances of collection in case of subsequent
legal proceedings. Recordkeeping requirements for Section 26.115(d) are established by
Section 26.715(b)(2).
10 CFR 26.115(f)(3) requires that, if someone other than the collector observed the collection,
the collector must record the observer’s name on the CCF. This requirement is an integral part
of the collection procedure and is essential to documenting the identity of the observer in case
of subsequent legal proceedings. Recordkeeping requirements for Section 26.115(f)(3) are
established by Section 26.715 (b)(2).
10 CFR 26.117(c) – (e), and (k) specify the documentation procedures to ensure chain of
custody of urine specimen. These procedures ensure the integrity of the collection process and
shipment of specimens to the testing laboratory, and protect the donor. Section 26.715(b)(2)
establishes the recordkeeping requirements for Section 26.117(c), (d), and (e). No
recordkeeping requirement is established under Section 26.117(k), but the procedures
described in the section ensure that the licensee or other entity uses a shipping service that
tracks custody of each package.
•
10 CFR 26.117(c) requires the collector to place an identification label containing the
date, the donor’s specimen number, and any other identifying information provided or
required by the FFD program securely on each specimen container.
•
10 CFR 26.117(d) requires the donor to initial the identification label(s) on the specimen
bottle(s) and to read and sign a statement on the CCF certifying that the specimen(s)
identified as having been collected from the donor is, in fact, the specimen(s) that the
donor provided.
•
10 CFR 26.117(e) requires the collector to complete the CCF (or CCFs for both Bottle A
and Bottle B, if split specimens procedures were followed) and certify proper completion
of the collection.
•
10 CFR 26.117(k) requires that custody accountability of shipping containers during
shipment by couriers, express carriers, and the postal service must be maintained by a
tracking system provided by the courier, express carrier, or postal service. Use of such
tracking systems by couriers, express carriers, and the postal service is an ordinary
business practice. This is not a third-party disclosure requirement, but ensures that the
licensee or other entity utilizes shipping services that can afford this level of package
tracking.
10 CFR 26.119(a), (b), (e), and (f) ensure that if a donor cannot provide a specimen within the
3-hours allocated for collection, then a medical evaluation, based on specified information and
29
instructions, is prepared and provided in writing to the MRO. Section 26.715(b)(6) establishes
the recordkeeping requirements for Section 26.119(a), (b), (e), and (f).
•
10 CFR 26.119(a) requires a donor who has not provided a specimen of at least 30 mL
within the 3 hours permitted for urine collection to obtain, within 5 business days, an
evaluation from a licensed physician, or from the MRO if the MRO has the appropriate
expertise. This requirement ensures that a qualified MRO or licensed physician prepares
an evaluation of whether the medical condition of the donor was or could have with a
high probability been the basis for the donor’s failure to provide a specimen.
•
10 CFR 26.119(b) requires the MRO, if the MRO is not performing the evaluation, to
provide the physician who is performing the evaluation with information about the donor
and the testing requirements, and instructions about the determination to be made by
the physician.
•
10 CFR 26.119(e) requires a physician who performs an evaluation of the donor’s failure
to provide a sufficient specimen to prepare a written statement of his or her
determination and the basis for it and to provide the statement to the MRO.
•
10 CFR 26.119(f) requires the physician, if he or she determines that the donor’s
medical condition is a serious and permanent or long-term disability that is highly likely
to prevent the donor from providing a sufficient amount of urine for a very long or
indefinite period of time, to set forth this determination and the reasons for it in the
written statement to the MRO.
10 CFR 26.125(b) and (c) ensure that the training, competency of the technicians and staff of a
LTF to correctly use the instruments and devices that the LTF has selected can be verified. This
is an important support for the review process underlying determinations of fitness. In addition,
records of training and competency may be important evidence in any litigation that may occur
with respect to test results. Records of training and competency of LTF personnel also supports
reliance by licensees and other entities on test results from testing that was performed by
another Part 26 program. Recordkeeping requirements for Section 26.125(b) and (c) are
established by Section 26.715(a) and (b)(1).
•
10 CFR 26.125(b) requires technicians who perform urine specimen testing to have
documented proficiency in operating the testing instruments and devices used at the
LTF.
•
10 CFR 26.125(c) requires LTF files to include each individual’s resume of training and
experience, certification of license, if any; references; job descriptions; records of
performance evaluations and advancement; incident reports, if any; results of tests that
establish the employee’s competency for the position he or she holds, including
certification that personnel are proficient in conducting testing; and appropriate data to
support determinations of honesty and integrity required by Part 26.
10 CFR 26.127(a) – (e) describe the QA/QC processes that each LTF conducting testing must
utilize. These processes ensure to the accuracy and integrity of the specimen testing and chainof-custody. Section 26.715(a) establishes the recordkeeping requirements for Section 26.127(a)
– (e).
30
•
10 CFR 26.127(a) requires the LTF to develop, implement, and maintain clear and welldocumented procedures for accession, receipt, shipment, and testing of urine
specimens.
•
10 CFR 26.127(b) requires the LTF to have written chain-of-custody procedures
describing the methods to be used to maintain control and accountability of specimens
from receipt through completion of testing and reporting of results, during storage and
shipping to the HHS lab, and continuing until final disposition of the specimens.
•
10 CFR 26.127(c) requires the LTF to develop, implement, and maintain written
standard operating procedures for each assay performed for drug and specimen validity
testing. If the LTF performs validity screening tests, the LTF is also required to develop,
implement, and maintain written standard operating procedures for each test. The
procedures must include detailed descriptions of the principles of each test; preparation
of reagents, standards, and controls; calibration procedures; derivation of results;
linearity of the methods; cutoff values; mechanisms for reporting results; controls; criteria
for unacceptable specimens and results; reagents and expiration dates; and references.
•
10 CFR 26.127(d) requires the LTF to develop, implement, and maintain written
procedures for instrument and device setup and normal operation that include a
schedule for checking critical operating characteristics for all instruments and devices;
tolerance limits for acceptable function checks; and instructions for major
troubleshooting and repair.
•
10 CFR 26.127(e) requires the LTF to develop, implement, and maintain written
procedures for remedial actions to be taken when systems and instrumented and noninstrumented testing devices (if used for validity screening tests) are out of acceptable
limits or errors are detected. Each facility is required to document adherence to
established procedures and to take corrective action when necessary. In addition, all
facilities are required to have systems in place and to verify all stages of testing and
reporting and to document the verification.
10 CFR 26.129(a), (b) and (b)(1), (d) and (h) specify the QA/QC processes used at an LTF
ensure to the security of specimens, to identify tampering events, and to take appropriate and
timely actions if necessary. These requirements protect donors from inaccurate results, provide
assurance that specimens of questionable validity are identified, and ensure to the integrity of
the testing process. Section 26.129(h) is not a third-party disclosure requirement, but ensures
that the licensee or other entity utilizes shipping services that afford package specific tracking.
•
10 CFR 26.129(a) requires each LTF to limit access to secured areas only to specifically
authorized individuals whose authorization is documented. This requirement, involving
the collection of signatures of persons visiting the secured areas of testing facilities and
a check of their credentials or other authorization for such entry, ensures that
unauthorized persons do not gain access to testing areas where they might seek to
subvert the testing process. Section 26.715(b)(13) establishes the recordkeeping
requirements for Section 26.129(a).
•
10 CFR 26.129(b) requires LTF personnel to inspect each package when specimens are
received for evidence of possible tampering and to compare the information on the
specimen containers within each package to the information on the accompanying
31
CCFs, and to attempt to resolve any discrepancies. When resolving any discrepancies,
LTF personnel are required to obtain a memorandum for the record from the specimen
collector to document correction of the discrepancy. The memorandum must accompany
the specimens and CCFs if the specimens must be transferred. This requirement
ensures that a record of the resolution of any discrepancies involving information about
specimens is prepared and accompanies the specimens following the resolution of the
discrepancy. This will avoid duplicative efforts to resolve discrepancies and will ensure
that the information accompanying the specimen is correct. Section 26.715(b)(2)
establishes the recordkeeping requirements for Section 26.129(b).
•
10 CFR 26.129(b)(1) requires LTFs to report to licensee senior management any
indications of tampering with specimens in transit from the collection site or at a testing
facility, or discrepancies in the information on specimen bottles or on the accompanying
CCFs. Such reports must be made as soon as practical, but no later than 8 hours after
identification of the tampering event. The timeliness of this requirement is necessary so
that the licensee or other entity can make a 24-hour notification to the NRC under
Section 26.719(b). Section 26.715(b)(3) establishes the recordkeeping requirements for
Section 26.129(b)(1).
•
10 CFR 26.129(d) requires that the procedures used by the LTF for tracking custody and
control of specimens protect the identity of the donor. The LTF must provide
documentation of the testing process and each transfer of custody of the specimen,
including the date, purpose, and individual receiving the specimen.
•
10 CFR 26.129(h) requires that custody accountability of shipping containers during
shipment by couriers, express carriers, and the postal service must be maintained by a
tracking system provided by the courier, express carrier, or postal service.
10 CFR 26.135(b) allows the donor, upon notification of a positive, adulterated, or substituted
test result, to request that Bottle B of a split specimen (as described in Section 26.113) be
tested at a second HHS lab under the procedures in Section 26.165(b). This requirement
ensures that a record exists of the donor’s approval for the MRO to request the additional
specimen testing at a second HHS certified laboratory, in case of subsequent legal proceedings.
Recordkeeping requirements for Section 26.135(b) are established by Section 26.715(b)(6).
10 CFR 26.137(a) requires each LTF to develop and implement a QA program and procedures
encompassing all aspects of the testing process. This requirement is an integral part of the
QA/QC process for all testing and laboratory facilities. The requirement is necessary to help
ensure accurate and repeatable results, protect donors from inappropriate sanctions, and to
provide assurance that specimens of questionable validity are detected. Section 26.715(b)(3)
establishes the recordkeeping requirements for Section 26.137(a).
10 CFR 26.137(b)(1)(ii) and (b)(1)(iii) establish the performance testing criteria an LTF must
meet if point-of-collection testing devices are used to perform validity screening testing. These
requirements protect donors from inaccurate drug and validity test results. Section 26.715(b)(7)
establishes the recordkeeping requirements for Section 26.137(b)(1)(ii) and (b)(1)(iii).
•
10 CFR 26.137(b)(1)(ii) requires the licensee or other entity before using the test, to
ensure that the validity screening test, by lot number, effectively identifies specimens of
32
questionable validity by meeting the performance testing and quality control
requirements listed in this section.
•
10 CFR 26.137(b)(1)(iii) requires an LTF that has placed a validity screening test in
service to either verify that the device remains on the SAMHSA-approved list or if the list
is unavailable, ensure the manufacturer’s documentation documents the test’s validity
and that the licensee conducts performance testing at a nominal annual frequency.
10 CFR 26.137(b)(3) requires that each LTF performing validity screening testing must submit
at least one donor specimen out of every 10 that test negative to an HHS lab as part of the
LTF’s QA program. This requirement is an integral part of the QA/QC process, protects donors
from inaccurate test results, and provides assurance that validity test performed by an LTF is
accurate. Section 26.715(b)(3) establishes the recordkeeping requirements for
Section 26.137(b)(3).
10 CFR 26.137(d)(6) requires that each LTF performing initial validity testing must submit at
least one donor specimen out of every 10 that test negative to an HHS lab as part of the LTF’s
QA program. This requirement is an integral part of the QA/QC process, protects donors from
inaccurate test results, and provides assurance of the accuracy of validity tests performed by
LTFs. Recordkeeping requirements for Section 26.137(d)(6) are established by
Section 26.715(b)(3).
10 CFR 26.137(e)(7), (f)(5), and (h) specify the QA/QC processes to be used at an LTF to
protect donors from inaccurate test results.
•
10 CFR 26.137(e)(7) requires each LTF to document procedures to ensure that
carryover (i.e., materials from a previous test that have not been adequately purged from
the apparatus) does not contaminate the testing of a donor’s specimen.
•
10 CFR 26.137(f)(5) requires each LTF to record findings and corrective actions taken,
when applicable, for the investigation of any errors or unsatisfactory performance
discovered in the testing of QC samples, donor specimens, or through the processing of
management reviews or MRO reviews. The records of each investigation must be
signed and dated by the individual(s) responsible for the day-to-day management of the
LTF, and reported to appropriate management. Section 26.715(b)(8) establishes the
recordkeeping requirement for Section 26.137(f)(5).
•
10 CFR 26.137(h) requires the LTF to label the standards and controls with the date of
receipt, when prepared or opened, when placed in service, and when scheduled for
expiration. Section 26.715(b)(5) establishes the recordkeeping requirements for
Section 26.137(h).
10 CFR 26.139(d) requires LTFs to prepare information on drug and validity tests performed, for
inclusion in the annual FFD program performance report submitted by the licensee or other
entity to the NRC under Section 26.717. This requirement ensures that the NRC can monitor
testing program effectiveness. The NRC has concluded that annual reporting creates the
appropriate balance between reporting burden and the NRC’s need for information.
Section 26.717 specifies the D&A testing information to be included in each FFD program
performance report. Section 26.717(b) and (e) establish the reporting requirements for
Section 26.139(d).
33
10 CFR 26.153(e) and (f) establish the pre-award inspection and evaluation that a licensee or
other entity must complete prior to using a new HHS lab for testing, and details the minimum
requirements that a licensee or other entity must include in the contract with the HHS lab.
•
10 CFR 26.153(e) requires a licensee or other entity, before awarding a contract to an
HHS lab, to conduct a pre-award inspection and evaluation of the procedural aspects of
the laboratory’s drug testing operations. This review ensures that the HHS lab meets the
requirements in Part 26 specified to conduct drug and validity testing.
Section 26.715(b)(9) establishes the recordkeeping requirements for Section 26.153(e).
•
10 CFR 26.153(f) establishes the minimum requirements that must be included in each
contract between a licensee or other entity and the HHS lab that is to perform drug and
validity testing under Part 26. The minimum requirements include complying with
applicable State licensor requirements, making qualified laboratory personnel available
to testify in proceedings, maintaining records in accordance with Section 26.37,
providing access to records, conflict of interest provisions, and laboratory access for
inspections. Section 26.713(e) establishes the recordkeeping requirements for
Section 26.153(f).
10 CFR 26.153(g) requires licensees or other entities who use a form other than the current
Federal CCF to provide a memorandum to the HHS lab explaining why a non-Federal form was
used, and to ensure that the form used contains all the required information on the Federal Drug
Testing CCF (OMB Control No. 0930-0158). This requirement is consistent with the HHS
Guidelines stating that laboratories may reject any specimen that is submitted for testing with a
non-Federal CCF unless the licensee or other entity provides a memorandum for the record.
This paragraph is necessary to prevent licensee’s and other entity’s specimens from being
rejected. Section 26.715(b)(2) establishes the recordkeeping requirements for
Section 26.153(g)).
10 CFR 26.155(a)(1), (a)(3) – (a)(5), (b), (c), (e) and (f) align with the HHS laboratory
certification requirements under the HHS Mandatory Guidelines for Federal Workplace Drug
Testing Programs (HHS Guidelines). These requirements ensure the scientific validity and
supportability of test results. Recordkeeping requirements for Section 26.155(a)(1), (a)(3), (b),
and (c) are established by Section 26.155(f); Section 26.155(a)(4) established by
Section 26.157; and the Section 26.155(a)(5) requirements are established by
Section 26.715(b)(3). The recordkeeping burden for Section 26.155(e) and (f) is captured under
OMB Control No. 0930-0158.
•
10 CFR 26.155(a)(1) requires day-to-day management of the HHS lab to be performed
by an individual with documented scientific qualifications in analytic forensic toxicology.
•
10 CFR 26.155(a)(3) requires the individual to ensure the continued competency of
laboratory personnel by documenting their in-service training, reviewing their work
performance, and verifying their skills.
•
10 CFR 26.155(a)(4) requires the day-to-day manager to review, sign, and date
procedures to be followed by laboratory personnel whenever the procedures are first
placed into use or changed or when a new individual assumes responsibility for
34
management of the laboratory, and to ensure that copies of all procedures are
maintained.
•
10 CFR 26.155(a)(5) requires the day-to-day manager to maintain a QA program that,
among other things, documents the validity, reliability, accuracy, precision, and
performance characteristics of each test and test system.
•
10 CFR 26.155(b) requires that each HHS lab have at least one certifying scientist to
certify test results. The paragraph specifies the requirements for the certifying scientist.
•
10 CFR 26.155(c) requires that each HHS lab assign at least one individual to be
responsible for day-to-day operations and supervision of the technical analysts. The
paragraph specifies the requirements for the analysts’ supervisor.
•
10 CFR 26.155(e) requires that HHS labs make available continuing education programs
for personnel.
•
10 CFR 26.155(f) requires each laboratory personnel file to include a resume, any
professional certifications or licenses, a job description, and documentation to show that
the individual has been properly trained to perform his or her job function(s).
10 CFR 26.157(a) – (e) align with the HHS laboratory procedures requirements in the HHS
Guidelines. These recordkeeping requirements ensure to the chain of custody of specimens and
the integrity of the testing process. The recordkeeping burden for Section 26.157(a), (b), (c), (d)
and (e) is captured under OMB Control No. 0930-0158.
•
10 CFR 26.157(a) requires HHS labs to develop, implement, and maintain clear and
well-documented procedures for accession, receipt, shipment, and testing of urine
specimens.
•
10 CFR 26.157(b) requires HHS labs to have written chain-of-custody procedures
describing the methods to be used to maintain control and accountability of specimens
from receipt through completion of testing and reporting of results, during storage and
shipping to another HHS lab, if required, and continuing until final disposition of the
specimens.
•
10 CFR 26.157(c) requires HHS labs to develop, implement, and maintain a written
standard operating procedures manual for each assay performed for drug and specimen
validity testing. If an LTF uses non-instrumented devices to perform validity screening
tests, the LTF must develop, implement, and maintain written standard operating
procedures for each device.
•
10 CFR 26.157(d) requires HHS labs to develop, implement, and maintain written
procedures for instrument and device setup and normal operation.
•
10 CFR 26.157(e) requires HHS labs to develop, implement, and maintain written
procedures for remedial actions to be taken when systems and non-instrumented testing
devices (if used for validity screening tests) are out of acceptable limits or errors are
detected. Each facility is required to maintain documentation that these procedures are
followed and that all necessary corrective actions are taken. In addition, all facilities are
35
required to have systems in place and to verify all stages of testing and reporting and to
document the verification.
10 CFR 26.159(a), (b)(1), (c) – (f), and (i) align with the HHS lab certification requirements
under the HHS Guidelines for specimen chain of custody at the laboratory. The recordkeeping
burden for Section 26.159(a) is captured under OMB Control No. 0930-0158. Recordkeeping
requirements for Section 26.159(b) are established by Section 26.715(b)(3) and
Section 26.159(c), (d), (e), (f), and (i) are established by Section 26.715(b)(2). Reporting
requirements for reports of tampering to NRC under Section 26.159(b) are established by
Section 26.719(b)(3).
•
10 CFR 26.159(a) requires each HHS lab to limit access to secured areas and only to
those individuals whose authorization is documented.
•
10 CFR 26.159(b)(1) requires HHS labs to inspect each shipment of specimens for
evidence of possible tampering and to compare information on specimen bottles within
each package to the information on the accompanying CCFs. Any direct evidence of
tampering or discrepancies in the information on the specimen bottles and the CCFs
attached to the specimen bottles must be reported to the licensee or other entity within
24 hours of the discovery and must be noted on the CCF for each specimen contained in
the package.
•
10 CFR 26.159(c) requires HHS lab personnel to use laboratory internal CCFs when
conducting initial and confirmatory tests, and to retain these forms in secure storage.
•
10 CFR 26.159(d) requires the internal CCF used by an HHS lab to allow for
identification of the donor, and documentation of the testing process and transfers of
custody of the specimen.
•
10 CFR 26.159(e) requires that each time a specimen is handled or transferred within
the HHS lab, that the HHS lab personnel document on the CCF the date and purpose.
Authorized technicians are required to sign and complete CCFs for each specimen or
aliquot received.
•
10 CFR 26.159(f) requires that, when transferring a specimen to a second HHS lab, the
original CCF is packaged with the urine specimen bottle.
•
10 CFR 26.159(i) requires that, unless otherwise authorized in writing, specimens be
retained in storage for 1 year.
10 CFR 26.163(a)(2) specifies that if initial validity testing indicates that a specimen is dilute,
and the immunoassay response of any drug or drug metabolite test is equal to or greater than
50 percent of the cutoff, the licensee or other entity may require the HHS lab to test the
specimen for that drug or drug metabolite to the limit of detection (LOD) for the confirmatory
assay. The laboratory shall report the numerical values (i.e., the quantitative test result)
obtained from this special analysis to the MRO. This requirement enables the licensee or other
entity to validate a dilute result to protect the donor from an inaccurate test result, to provide
assurance that a specimen of questionable validity is detected, and to ensure the integrity of the
testing process. Section 26.715(b)(6) establishes the recordkeeping requirements for
Section 26.163(a)(2)
36
10 CFR 26.165(b)(1) – (b)(4), (b)(6), (c)(4), (f)(1), (f)(1)(ii), (f)(1)(iv), and (f)(2) provide donors
with the opportunity to request that either Bottle B of a split specimen or an aliquot of a single
specimen be tested if an initial non-negative test result is obtained, and to ensure that no
records of a temporary administrative action taken as a result of an initial non-negative test
result are retained if a negative report is received from the testing of Bottle B or retesting of an
aliquot of a single specimen. These requirements are necessary to protect donors from
inaccurate results and to provide assurance that specimens of questionable validity are
detected. They also assure to the donor the confidential nature of temporary administrative
actions.
•
10 CFR 26.165(b)(1) specifies that for a confirmed positive, adulterated, or substituted
test result reported on a single specimen (Bottle A of a split specimen), the donor may
request that the MRO verify the results from the initial laboratory by requiring the
retesting of an aliquot of the single specimen or the testing of the Bottle B split specimen
at a second HHS lab. Section 26.715(b)(6) establishes the recordkeeping requirements
for Section 26.165(b)(1).
•
10 CFR 25.165(b)(2) requires the MRO to inform the donor that he or she may, within
3 business days of notification by the MRO of the confirmed positive, adulterated, or
substituted test result, request the re-testing of an aliquot of the single specimen or the
testing of the Bottle B split specimen. The MRO shall provide the donor with specific
instructions for making this request (i.e., providing telephone numbers or other contact
information). The MRO is required to have the ability to receive the donor’s calls at all
times during the 3-day period (e.g., by use of an answering machine with a time stamp
feature when there is no one in the MRO’s office to answer the phone). The donor’s
request may be oral or in writing.
•
10 CFR 25.165(b)(3) requires the donor to provide his or her permission to the MRO to
initiate the retesting of an aliquot from a single specimen or the testing of the Bottle B
split specimen.
•
10 CFR 25.165(b)(4) provides that if the donor has not requested a retest of an aliquot of
a single specimen or a test of the split specimen within 3 business days, the donor may
present to the MRO information documenting that serious injury, illness, lack of actual
notice of the confirmed test result, inability to contact the MRO, or other circumstances
unavoidably prevented the donor from making a timely request. If the MRO concludes a
legitimate reason existed for the donor’s inability to make contact within 3 business days,
the MRO shall direct that specimen retesting take place.
•
10 CFR 26.165(b)(6) requires the second HHS lab that re-tests an aliquot of a single
specimen or tests the Bottle B split specimen to provide the quantitative test results to
the MRO, and then directs the MRO to provide the test results to the donor.
Section 26.715(b)(6) establishes the recordkeeping requirements for
Section 26.165(b)(6).
•
10 CFR 25.165(c)(4) requires the second HHS lab conducting retesting of an aliquot of a
single specimen or the testing of the Bottle B split specimen to report test results to the
licensee’s or other entity’s MRO. Section 26.715(b)(6) establishes the recordkeeping
requirements for Section 26.165(c)(4).
37
•
10 CFR 26.165(f)(1) specifies that a licensee or other entity may administratively
withdraw an individual’s authorization on the basis of a first confirmed positive,
adulterated, or substituted test result until the results of testing Bottle B or retesting an
aliquot of a single specimen are available and have been reviewed by the MRO.
Paragraph 26.165(f)(1) requires that licensees and other entities may not disclose the
temporary administrative action against an individual whose initial drug test result is not
subsequently confirmed by the MRO as a violation of FFD policy in response to a
suitable inquiry conducted under Section 26.63, a background investigation conducted
under Part 26, or to any other inquiry or investigation. The licensees or other entities
must provide access to the system of files and records to personnel who are conducting
reviews, inquiries into allegations, audits pursuant to Section 26.41, and to NRC
inspectors, to ensure that no records are retained. The licensees or other entities shall
provide the tested individual with a written statement that the records specified in
sections 26.713 and 26.715 have not been retained, and shall inform the individual in
writing that the temporary administrative action that was taken will not be disclosed and
need not be disclosed by the individual in response to requests for a self-disclosure of
PDI.
•
10 CFR 26.165(f)(1)(ii) requires that the licensee or other entity eliminate any matter
from the individual’s FFD record and other records that could link the individual to the
temporary administrative action immediately upon receipt of a negative report from the
testing of Bottle B or retesting the aliquot of a single specimen.
•
10 CFR 26.165(f)(1)(iv) requires that the licensee or other entity provide the tested
individual with a written statement that the records specified in sections 26.713 and
26.715 have not been retained and shall inform the individual in writing that the
temporary administrative action that was taken will not be disclosed.
•
10 CFR 26.165(f)(2) requires that if the donor requests that either Bottle B be tested or
an aliquot of a single specimen be retested and either is not available, the MRO shall
cancel the test and inform the licensee or other entity that another collection is required
under direct observation as soon as reasonably practical. The licensee or other entity
shall eliminate from the donor’s personnel and other records any matter that could link
the donor to the original positive, adulterated or substituted test result(s) or any
temporary administrative action.
10 CFR 26.167(a) specifies that the QA program of each HHS lab must encompass all aspects
of the testing process (including, but not limited to, specimen accessioning, chain of custody,
security and reporting of results, initial and confirmatory testing, certification of calibrators and
controls, and validation of analytical procedures). The performance characteristics (e.g.,
accuracy, precision, LOD, limit of quantitation (LOQ), specificity) of each test must be validated
and documented for each test. Validation procedures must document that carryover does not
affect the donor’s specimen results. Periodic re-verification of analytical procedures is required.
The QA procedures must ensure that the HHS lab monitors the conduct of each step in the
testing process. These recordkeeping requirements ensure to the scientific legitimacy and
accuracy of test results. Section 26.715(b)(7) establishes the recordkeeping requirements for
Section 26.167(a).
38
10 CFR 26.167(c)(2)(i) requires that refractometers used by HHS labs must report and display
the specific gravity to 4 decimal places and to be interfaced with a laboratory information
management system or computer and/or to generate a hard copy or digital electronic display to
document the numerical result. This requirement is necessary to establish the specifications for
refractometers used by HHS labs that perform validity testing on urine specimens. The section
does not create any separate records, but determines the types of records that will be reported
under Section 26.161(d), (e) and (f).
10 CFR 26.167(f) requires the licensee or other entity to ensure that the HHS lab investigates
any testing errors or unsatisfactory performance. Paragraph 26.167(f)(1) requires sufficient
records to be maintained to furnish evidence of activities affecting quality. The identification of
the significant condition, the cause of the condition, and the corrective action taken are required
to be documented and reported to appropriate levels of management. Paragraph 26.167(f)(3)
requires, if a false positive error occurs when testing a BPTS and the error is determined to be
technical or methodological, that the licensee or other entity instruct the laboratory to provide all
quality control data from the batch or analytical run of specimens that included the false positive
sample. If retesting is required, the retesting must be documented by a statement signed by the
laboratory’s certifying scientist. These requirements are consistent with the HHS Guidelines and
with Part 50, Appendix B, Quality Assurance Requirements for Nuclear Power Plants and Fuel
Reprocessing Plants, Criterion XVI, Quality Assurance Records. These requirements are
necessary to protect donors from inaccurate results, to provide assurance that specimens of
questionable validity are detected, and to ensure the integrity of the testing process.
Section 26.715(b)(7) establishes the recordkeeping requirements for Section 26.167(f).
10 CFR 26.167(h) requires laboratory calibrators and controls to be prepared using pure drug
reference materials, stock standard solutions obtained from other laboratories, or standard
solutions that are obtained from commercial manufacturers and that are properly labeled as to
content and concentration. The standards and controls must be labeled with the dates when
they are received, when prepared or opened, when placed in service, and when scheduled for
expiration. These requirements are consistent with the HHS Guidelines and are standard
business and laboratory practices necessary for any laboratory to conduct forensic drug testing,
and to ensure the scientific legitimacy of test results. As standard business practices, they are
not considered a burden for this analysis. Section 26.75(b)(3) establishes the recordkeeping
requirements for Section 26.167(h).
10 CFR 26.168(a) requires each licensee or other entity to submit BPTSs to the HHS lab, and
describes the number of specimens to be submitted each quarter of the calendar year. No,
recordkeeping requirements are contained in this section, but the burden for submitting BPTS is
accounted for under Section 26.168(g).
10 CFR 26.168(g) specifies that each licensee or other entity must use BPTSs that have been
certified by the BPTS supplier to meet the various formulation criteria (e.g., drug positive,
adulterated, dilute, substituted). The BPTS will provide documentation that the specimens
provided meet the formulation criteria
10 CFR 26.168(h)(2) requires each licensee or other entity to ensure that the BPTS supplier
provides an expiration date on each sample.
10 CFR 26.168(i)(2) requires each licensee or other entity to use a complete a CCF, place
fictional initials on the specimen bottles’ labels/seals, and indicate on the MRO’s copy of the
CCF that the specimen is a BPTS.
39
10 CFR 26.169(a), (c), (c)(1) – (c)(5), and (e) – (h) ensure that licensees and other entities
receive test result reports and testing-related information from HHS labs performing specimen
testing. The recordkeeping and reporting requirements under Section 26.169 are established by
contract between licensees and other entities and HHS labs. Section 26.715(b)(2), (b)(3), (b)(5),
(b)(6), and (b)(8) establishes the recordkeeping requirements for Section 26.169.
•
10 CFR 26.169(a) requires HHS labs to report test results to the MRO within 5 business
days after receiving the specimen. Before reporting any test result, a certifying scientist
must certify that the result is correct. The report must identify the substances for which
testing was performed; the results of the validity and drug tests; the cutoff levels for
each; any indications of tampering, adulteration, or substitution that may be present; the
identification number assigned to the specimen by the licensee or other entity; and the
specimen identification number assigned by the HHS lab.
•
10 CFR 26.169(c) requires HHS labs to report to the MRO of a licensee or other entity
the test results for all specimens tested (both negative and positive).
•
10 CFR 26.169(c)(1) requires HHS labs to report all positive, adulterated, substituted,
dilute, and invalid test results to the MRO.
•
10 CFR 26.169(c)(2) requires, if request by the MRO, that the HHS lab report the
numerical values (i.e., quantitative values) for all positive drug test results. The HHS lab
is required to provide the quantitative values for confirmatory positive opiate test results
for morphine or codeine with a concentration greater than or equal to 15,000 ng/mL
(even if not requested by the MRO).
•
10 CFR 26.169(c)(3) requires HHS labs to report to the MRO the numerical test result
values for adulterated and substituted specimens.
•
10 CFR 26.169(c)(4) requires the HHS lab to contact the MRO and both will decide
whether testing by another HHS lab would be useful in being able to report a positive or
adulterated test result. This contact may occur through any secure electronic means
(e.g., telephone, fax, e-mail). If no further testing is necessary, the HHS lab must report
an invalid test result for the specimen.
•
10 CFR 26.169(c)(5) an HHS lab may report to the MRO that the quantitative value
"exceeds the linear range of the test," that the quantitative value is “equal to or greater
than ,” or may report an accurate
quantitative value above the upper limit of the linear range that was obtained by diluting
an aliquot of the specimen.
•
10 CFR 26.169(e) specifies that an HHS lab may transmit results by electronic means
(e.g., teleprinters, facsimile, or computer) in a manner designed to ensure the
confidentiality of the information, and prohibits transmitting results verbally by telephone.
•
10 CFR 26.169(f) specifies that for negative results, the HHS lab may fax, courier, mail,
or electronically transmit a computer-generated electronic report and/or a legible image
or copy of the completed CCF to the MRO. However, for positive, adulterated,
40
substituted, dilute, and invalid results, the laboratory shall fax, courier, mail, or
electronically transmit a legible image or copy of the completed CCF to the MRO.
•
10 CFR 26.169(g) requires the HHS lab for a specimen that has a positive, adulterated,
substituted, dilute, or invalid result, to retain the original CCF and transmit to the MRO a
copy of the original CCF signed by a certifying scientist.
•
10 CFR 26.169(h) requires the HHS lab performing tests for a licensee or other entity to
prepare an annual statistical summary report of urinalysis testing results for that year. To
avoid sending data from which it is likely that information about an individual donor’s test
result can be inferred, the laboratory is not permitted to send a report if the licensee or
other entity has fewer than 10 specimen test results in a one-year period. The summary
report must be sent within 14 calendar days after the end of the one-year period covered
by the report. The statistical summary report is needed by the licensee or other entity to
prepare the annual FFD program performance report submission to the NRC required
under Section 26.717. Information that is required to be included in the statistical
summary report is listed in Section 26.169(h)(1) – (h)(8).
10 CFR 26.183(a), (c)(1), and (d)(1)(ii)(D) specifies MRO qualifications, responsibilities, and
procedures to maintain confidentiality of donor information collected as part of the test result
review process.
•
10 CFR 26.183(a) establishes the required qualifications of the MRO and requires a
record of the degree held by the MRO and the results of the MRO examination
administered by a nationally-recognized MRO certification board or sub-specialty board.
This requirement ensures that a record is available that demonstrates that the MRO
meets the qualification requirements in Part 26.
•
10 CFR 26.183(c)(1) requires the MRO to examine alternate causes of a positive,
adulterated, substituted, invalid, and, at the licensee’s or other entity’s discretion, special
analyses test results of dilute specimens, including reviewing records provided by the
donor (e.g., prescription medication use, information on medical treatment).
•
10 CFR 26.183(d)(1)(ii)(D) requires the MRO to maintain the confidentiality of records
and donor personal information, except as permitted under Part 26, to ensure the
security of data transmission and communication of test results to the licensee’s or other
entity’s designated reviewing official.
10 CFR 26.183(d)(2)(i) and (d)(2)(ii) describe the procedures that MRO staff must follow to
protect donor information collected as part of the testing process. These requirements define
the duties that MRO staff may perform (e.g., receive test results from the HHS lab, review test
result reports, schedule interviews with donors). These requirements protect donor due process
rights, ensure to the confidentiality of collected information, and define the activities that MRO
staff may perform. Section 26.713(a)(2) establishes the recordkeeping requirements for
Section 26.183(d)(2)(i) and (d)(2)(ii).
•
10 CFR 26.183(d)(2)(i) allows MRO staff, under the direction of the MRO, to receive and
review HHS lab reports of negative test results, and to notify the licensee or other entity
of these test results.
41
•
10 CFR 26.183(d)(2)(ii) specifies limitations on MRO staff reviews of positive,
adulterated, substituted, invalid, and at the licensee’s or other entity’s discretion, dilute
test results. MRO staff can review the HHS lab result and MRO copy of the CCF to
identify errors requiring correction, but must forward any changes to the MRO for review
and approval.
10 CFR 26.185(a), and (c) – (e) provide procedures for the review of drug test results by a
qualified and trained MRO, the MRO discussion of test results with a donor to evaluate if a
legitimate medical explanation exits for a test result, and the process to follow if the MRO is
unable to discuss test results with the donor. These provisions provide due process rights to
individuals tested under Part 26.
•
10 CFR 26.185(a) requires the MRO to review all positive, adulterated, substituted,
dilute, and invalid test results from the HHS lab to determine whether the donor has
violated the FFD policy before reporting the results to the licensee or other entity. The
MRO review assesses if any legitimate medical reason exists that may explain a test
result (e.g., use of a legally prescribed medication).
•
10 CFR 26.185(c) prohibits the MRO from determining that a positive, adulterated,
substituted, dilute, or invalid result or other occurrence is a FFD policy violation without
first giving the donor an opportunity to discuss the test result or occurrence and to
provide a legitimate medical explanation. If the MRO determines the result or occurrence
is an FFD violation after discussion with the donor, the MRO must notify the licensee or
other entity of this determination.
•
10 CFR 26.185(d) permits the MRO to confirm a positive, adulterated, substituted, dilute,
or invalid test result or other FFD policy violation without discussing the test result or
other occurrence with the donor under any of the following circumstances: (1) the MRO
has made and documented contact with the donor and the donor declined the
opportunity to discuss the test result or other FFD policy violation; (2) a representative of
the licensee or other entity, or a MRO staff member, has successfully made and
documented contact with the donor, has instructed the donor to contact the MRO, and
more than 1 business day has elapsed; or (3) the MRO is unable to contact the donor
after making all reasonable efforts and documenting the date and time of each attempt.
•
10 CFR 26.185(e) allows a donor, within 30 days of notification of an FFD violation, to
present the MRO with information documenting circumstances that unavoidably
prevented the donor from contacting the MRO or a representative of the licensee or
other entity in a timely manner. The MRO then would consider the request and whether
to reopen the procedure to discuss the test result with the donor.
10 CFR 26.185(f)(1) requires the MRO to consult with an HHS lab that reports an invalid result,
to determine if additional testing by another HHS lab would be useful. This requirement is
necessary to protect donors from inaccurate results, to provide assurance that specimens of
questionable validity are detected, and to ensure the integrity of the testing process.
10 CFR 26.185(f)(2) requires the MRO, if additional testing is not useful, to contact the donor to
determine if an acceptable medical explanation exists for the invalid result, and, if there is, to
report to the licensee that the test result is not an FFD policy violation, but that a negative test
42
result was not obtained. The licensee or other entity would then take additional actions (i.e.,
collect a second specimen from the individual).
10 CFR 26.185(h)(1) – (h)(3), (i)(1) – (i)(3), (j), (k), and (m) – (p) meet, in part, the legal
necessity of protecting the due process rights of individuals subject to Part 26, and provide prior
notice and documentation of that notice if needed in a legal proceeding. These requirements
afford donor protections against inaccurate results, provide assurance that attempts to subvert
the testing process are evaluated, and ensure to the integrity of the testing process.
Section 26.713(a)(2) establishes recordkeeping requirements for Section 26.185.
•
10 CFR 26.185(h)(1) requires the MRO, if the HHS lab reports a specimen as
substituted, to contact the donor and offer the donor an opportunity to provide an
acceptable medical explanation for the substituted result. The donor must provide
credible medical evidence within 5 business days that he or she produced the specimen
for which the HHS lab reported a substituted result. Any medical evidence must be
submitted through a referral physician who is experienced and qualified in the medical
issues involved.
•
10 CFR 26.185(h)(2) requires the MRO, if the MRO determines there is no acceptable
medical explanation for the substituted test result, to report to the licensee or other entity
that the specimen was substituted.
•
10 CFR 26.185(h)(3) requires that if the MRO determines that an acceptable medical
explanation exists for a substituted test result, the MRO must report to the licensee or
other entity that the donor has not violated the FFD policy.
•
10 CFR 26.185(i)(1) requires the MRO, if the HHS lab reports a specimen as
adulterated, to contact the donor and offer the donor an opportunity to provide an
acceptable medical explanation for the adulterated result. The donor is required to
provide creditable medical evidence within 5 business days that he or she produced the
adulterated result through normal human physiology.
•
10 CFR 26.185(i)(2) requires that if the MRO determines that no acceptable medical
explanation exists for an adulterated test result, the MRO must report to the licensee or
other entity that the specimen is adulterated.
•
10 CFR 26.185(i)(3) requires that if the MRO determines that an acceptable medical
explanation exists for an adulterated test result, the MRO must report to the licensee or
other entity that the donor has not violated the FFD policy.
•
10 CFR 26.185(j) requires that if the MRO determines that the donor has used another
individual’s prescription medication and evidence of drug abuse is found, the MRO must
report to the licensee that the donor has violated the FFD policy.
•
10 CFR 26.185(k) requires that if the MRO determines that a legitimate medical
explanation exists for a confirmatory positive drug test result (i.e., a prescription
medication identified by testing was used in the manner and at the dosage prescribed
and the results do not reflect a lack of reliability or trustworthiness), the MRO must report
to the licensee or other entity that there was no FFD policy violation.
43
•
10 CFR 26.185(m) provides that, based on the review of inspection and audit reports,
quality control data, multiple specimens, and other pertinent results, the MRO may
determine that a positive, adulterated, substituted or invalid test result is scientifically
insufficient for further action and may declare that a drug or validity test result is not an
FFD policy violation.
•
10 CFR 26.185(n) provides that, if a second HHS lab reconfirms the drug-positive test
result or reconfirms the adulterated, substituted, or invalid validity test result, the MRO is
to report an FFD policy violation to the licensee or other entity; if the second HHS lab
does not reconfirm the drug-positive test result, the MRO shall report that no FFD policy
violation has occurred; or if the second HHS lab does not reconfirm the adulterated,
substituted, or invalid validity test result, the MRO shall report that no FFD policy
violation has occurred.
•
10 CFR 26.185(o) requires the MRO to review drug test results from an individual whose
authorization was terminated or denied following a first violation of FFD policy. In order
to determine whether subsequent positive confirmatory drug test results represent new
drug use or remaining metabolites from the drug use that initially resulted in the FFD
policy violation, the MRO shall request from the HHS lab and the laboratory shall
provide, quantitation of the test results and other information necessary to make the
determination.
•
10 CFR 26.185(p) requires the MRO to review positive, adulterated, substituted, and
invalid test results and, in those instances in which the MRO determines that the donor
has violated the FFD policy of the licensee or other entity, to notify the designated
representative of the licensee or other entity in writing within 10 business days of
receiving the positive, adulterated, or substituted test result from the HHS lab.
10 CFR 26.187(d) requires that an SAE receive qualification training on: the background,
rationale, and scope of Part 26; key drug testing requirements of Part 26 (including specimen
collection, laboratory testing, MRO review, and problems in drug testing); key alcohol testing
requirements of Part 26 (including specimen collection, laboratory testing, MRO review, and
problems in alcohol tests); SAE qualifications and prohibitions; the role of the SAE in making
determinations of fitness and the return-to-duty process (including the initial evaluation, referrals
for education and/or treatment, the follow-up evaluation, continuing treatment
recommendations, and the follow-up testing plan); procedures for SAE consultation and
communication with licensees or other entities, MROs, and treatment providers; reporting and
recordkeeping requirements of Part 26; and issues that SAEs confront in carrying out their
duties under Part 26. Qualification training ensures that each SAE can perform required
functions under Part 26. Section 26.187(f) establishes the recordkeeping requirements for
Section 26.187(d).
10 CFR 26.187(f) requires the SAE to maintain documentation showing that he or she currently
meets all credentials, knowledge, and training requirements for a SAE established by
Section 26.187, and to provide this documentation upon request to NRC representatives,
licensees, or other entities who are relying upon or contemplating relying upon the SAE’s
services and to other individuals and entities, in accordance with the requirements of
Section 26.37. This requirement ensures that the training and competency of the SAE can be
verified by NRC inspectors, license auditors, or other staff of the licensee or other entity
conducting self-assessments or other activities. Records of training and competency may be
44
important evidence in any litigation that may occur with respect to test results and/or FFD
program management actions or sanctions. In addition, records of training and competency of
SAE will support reliance by licensees and other entities on FFD program results from other
Part 26 programs.
10 CFR 26.189(a) and (c) specify the procedures to make determinations of fitness under
Part 26 and ensure that each individual subject to an FFD program is fit-for-duty and not
impaired in any way that could affect their ability to safely and competently perform assigned
duties. These requirements also ensure that only qualified professionals complete a
determination of fitness and that records are maintained on the assessment — protecting the
due process rights of the individual and ensure that records on the determination are available if
needed in a legal proceeding.
•
10 CFR 26.189(a) provides that a determination of fitness must be performed on an
individual subject to an FFD program that may be in violation of the FFD policy, or
otherwise unable to safely and competently perform his or her assigned duties. A
determination of fitness must be made by a licensed or certified professional
appropriately qualified and with the necessary clinical expertise, as verified by the
licensee or other entity, to evaluate the fitness issues presented by an individual. A
written record of the determination of fitness must be prepared.
•
10 CFR 26.189(c) requires that a for cause determination of fitness be conducted
through a face-to-face interaction between the subject individual and the professional
making the assessment. If a determination concludes that an individual may be impaired
while on duty, then the subject individual would be determined to be unfit for duty and
the professional then would consult with FFD management to identify actions to ensure
that any possible limiting condition does not represent a threat to workplace or public
health and safety. A written record of the determination of fitness must be prepared.
10 CFR 26.189(d) permits the profession who completed a fitness determination, to modify the
evaluation and recommendations if new or additional information is obtained. This requirement
ensures that relevant information regarding an individual’s fitness is incorporated into the
determination of fitness. Any updates to the fitness determination would be documented and
maintained. Recordkeeping requirements for Section 26.189 are established by
Section 26.713(a)(4).
10 CFR 26.203(a) and (b) ensure that written policies and procedures of a fatigue management
program are available to subject individuals. The policy and procedures inform subject
individuals of rights and responsibilities under the program, and the consequences of not
complying with the fatigue management policy. The requirements also partially meet the legal
necessity of providing prior notice and documentation of that notice as evidence in a legal
proceeding. The provisions for policy and procedures for fatigue management are included in
the overall requirement regarding policy and procedures for FFD. Therefore, the burdens for the
written policy and procedures required under Section 26.203 are included under
Section 26.27(b) and (c) for the overall policy and procedures.
•
10 CFR 26.203(a) requires each licensee or other entity subject to Subpart I, to establish
a policy for the management of fatigue for all individuals who are subject to the
licensee’s FFD program and to incorporate it into the written policy required in
Section 26.27(b).
45
•
10 CFR 26.203(b) requires each licensee or other entity with a fatigue management
program under Subpart I, to develop, implement, and maintain written procedures that
describe the process to be followed when an individual makes a self-declaration that he
or she is not fit to safely and competently perform his or her duties for any part of a
working tour as a result of fatigue. The procedure must describe the individual’s and
licensee’s rights and responsibilities relating to self-declaration; describe requirements
for establishing controls and conditions under which an individual may be permitted or
required to perform work after that individual declared that he or she was not fit due to
fatigue; and, describe the process to be followed if the individual disagrees with the
results of a fatigue assessment. The procedures must also describe the process for
implementing the controls required by Section 26.205, describe the process for
conducting fatigue assessments, and describe the disciplinary actions, if any, that the
licensee may impose on an individual following a fatigue assessment and the conditions
and considerations for taking those disciplinary actions.
10 CFR 26.203(c) requires licensees to add specific KAs to the content of the training that is
required in Section 26.29(a) and the comprehensive examination required in section 26.29(b)
relating to knowledge of and ability to identify symptoms of work fatigue and contributors to
decreased alertness in the workplace. This requirement ensures that individuals assigned to
activities within the scope of Subpart I are provided with appropriate training with respect to
fatigue so that they are sufficiently skilled to detect conditions that arise from fatigue, they know
the proper action to be initiated, and that they understand the methods that will be used to
implement the FFD policy, the personal and public health and safety hazards associated with
fatigue, their roles and responsibilities in the implementation of the FFD program as it addresses
fatigue, the role of the MRO, and the EAP services available. The requirement also partially
meets the legal necessity of providing prior notice and having it documented for evidence in
legal proceedings.
10 CFR 26.203(d) requires all licensees and other entities to retain the following records for at
least 3 years or until the completion of all related legal proceedings, whichever is later:
•
10 CFR 26.203(d)(1): Records of work hours for individuals subject to the work hour
controls in Section 26.205;
•
10 CFR 26.203(d)(2): Records of shift schedules and shift cycles of individuals who are
subject to the work hour controls in Section 26.205(d)(3), in addition to records showing
the beginning and end times and dates of all 6-week or shorter averaging periods if
applying the maximum average work hour requirements of Section 26.205(d)(7);
•
10 CFR 26.203(d)(3): Documentation of waivers that is required in section 26.207(a)(4),
including the basis for granting the waivers.
•
10 CFR 26.203(d)(4): Documentation of work hour reviews that is required in
Section 26.205(e)(3) and (e)(4); and,
•
10 CFR 26.203(d)(5): Documentation of fatigue assessments that is required in
Section 26.211(g).
These section 26.203 requirements are necessary to ensure that licensees and other
entities establish and properly implement fatigue management programs. Licensees and
other entities must maintain records to demonstrate the fulfillment of regulatory
requirements for self-assessments and to support the preparation of annual reports, and to
46
provide information to the NRC to be used in evaluating the effectiveness of the fatigue
management programs required by Part 26.
10 CFR 26.203(e), (e)(1), and (e)(2) ensure that licensees and other entities provide information
to the NRC to demonstrate their fulfillment of regulatory requirements for fatigue management
and to allow the NRC to assess the effectiveness of the fatigue management requirements.
Collection of this information pertaining to significant fatigue-management topics, events, and
corrective actions is necessary to permit self-assessments and internal reviews and audits by
licensees and to permit timely evaluation of events that might become problems and that may
require action by the NRC staff to ensure that the health and safety of the public is not
endangered. Recordkeeping requirements for Section 26.203(e) are established by this section.
Reporting requirements for Section 26.203(e)(1), and (e)(2) are established by this section.
•
10 CFR 26.203(e) requires that the following information in a standard format is included
in the annual FFD program performance report required by Section 26.717.
•
10 CFR 26.203(e)(1) requires licensees to prepare a summary for each nuclear power
plant site of all instances during the previous calendar year in which the licensee waived
the work hour controls specified in Section 26.205(d)(1) through (d)(5)(i) and (d)(7) for
individuals described in Section 26.4(a). Each summary must include an accounting of
only those waivers under which work was performed. If it was necessary to waive more
than one work hour control during any single extended work period, the summary of
instances must include each of the work hour controls that were waived during the
period. For each category of individuals specified in section 26.4(a) the licensee shall
report: the number of instances in which each work hour control specified in
Section 26.205(d)(1)(i) through (d)(1)(iii), (d)(2)(i) and (d)(2)(ii), (d)(3)(i) through (d)(3)(v),
and (d)(7) was waived for individuals not working on outage activities; the number of
instances in which each work hour control specified in Section 26.205(d)(1)(i) through
(d)(1)(iii), (d)(2)(i) and (d)(2)(ii), (d)(3)(i) through (d)(3)(v), (d)(4) and (d)(5)(i), and (d)(7)
was waived for individuals working on outage activities; and a summary that shows the
distribution of waiver use among the individuals within each category of individuals
identified in Section 26.4(a) (e.g., a table that shows the number of individuals that
received only one waiver during the reporting period, the number of individuals that
received a total of two waivers during the reporting period).
•
10 CFR 26.203(e)(2) requires licensees to include a summary of corrective actions, if
any, resulting from the analyses of these data, including fatigue assessments.
10 CFR 26.203(f) requires licensees to audit the management of worker fatigue as required by
Section 26.41. This requirement ensures that licensees audit FFD program elements provided
by C/Vs and the FFD programs of any C/Vs that are accepted by the licensee. Reporting and
recordkeeping requirements for Section 26.203(f) are established by Section 26.41(f) and (g).
10 CFR 26.205(b), (c), (d)(1) – (d)(7), (d)(7)(i) – (d)(7)(iii), (d)(8), (e), and (e)(3) – (e)(4) ensure
that licensees and other entities properly implement work hour controls, including waivers of
those controls, for personnel performing activities on systems, structures, and components that
a risk-informed evaluation process has shown to be significant to public health and safety.
These records enable each licensee and other entity to review and correct any problems in
maintaining control of work hours, to enable the NRC to inspect the licensee’s and other entities’
fatigue management program, and to provide information for periodic audits.
Section 26.203(d)(1) establishes the recordkeeping requirements for Section 26.205(c) and
47
(d)(1); Section 26.203(d)(2) establishes the recordkeeping requirements for 26.205(d)(2)
through (d)(6); Section 26.203(d)(4) establishes the recordkeeping requirements for
Section 25.205(e)(1) through (e)(3); and Section 26.203(d)(4) establishes the recordkeeping
requirements for Section 26.205(e)(4).
•
10 CFR 26.205(b) requires each licensee to calculate the work hours of each individual
subject to this section as the amount of time each individuals performs duties for the
licensee.
•
10 CFR 26.205(c) requires each licensee to schedule the work hours of each individual
who is subject to this section consistent with the objective of preventing impairment from
fatigue due to the duration, frequency, or sequencing of successive shifts.
•
10 CFR 26.205(d)(1) requires each licensee to implement work hour controls for each
individual to ensure that, except as permitted by the waiver provisions in Section 26.207,
the individual’s work hours do not exceed 16 work hours in any 24-hour period, 26 work
hours in any 48-hour period, and 72 work hours in any 7-day period.
•
10 CFR 26.205(d)(2) requires each licensee to ensure that each individual has adequate
rest breaks between successive work periods, during which the individual does not
perform any duties for the licensee other than one shift turnover, either at the beginning
or the end of a shift, but not both.
•
10 CFR 26.205(d)(3) requires each licensee to ensure that each individual has, at a
minimum, the number of days off specified in this paragraph or comply with the
requirements for maximum average work hours in Section 26.205(d)(7).
•
10 CFR 26.205(d)(4) requires each licensee to ensure that each individual has, at a
minimum, the number of days off specified in this paragraph and exempts licensees from
the requirements of paragraph (d)(3) or (d)(7) of this section for individuals specified in
Section 26.4(a)(1) through (a)(4) for the first 60 days of an outage, while the individuals
are working on outage activities.
•
10 CFR 26.205(d)(5) requires each licensee to ensure that each individual has, at a
minimum, the number of days off specified in this paragraph and exempts licensees from
the requirements of paragraph (d)(3) or (d)(7) of this section for individuals specified in
Section 26.4(a)(5) for the first 60 days of a unit outage, security system outage, or
increased threat condition.
•
10 CFR 26.205(d)(6) specifies that the 60-day periods in paragraphs (d)(4) and (d)(5) of
this section may be extended for each individual in 7-day increments for each nonoverlapping 7-day period in which the individual has worked not more than 48 hours
during the unit or security system outage or increased threat condition, as applicable.
•
10 CFR 26.205(d)(7) provides each licensee with a voluntary alternative to the minimum
days off requirements of Section 26.205(d)(3), by permitting the licensee to comply with
the requirements for maximum average work hours.
•
10 CFR 26.205(d)(7)(i) establishes the alternative requirement to maintain each
individual’s weekly average of work hours at less than 54, calculated using an averaging
48
period of up to 6 weeks, which advances by 7 consecutive calendar days at the finish of
every averaging period.
•
10 CFR 26.205(d)(7)(ii) requires each licensee, when an individual’s work shift starts at
the end of a calendar day and concludes during the next calendar day, to either account
for all of an individual’s work hours as worked on the day the shift started or work hours
on the calendar days on which they were actually worked.
•
10 CFR 26.205(d)(7)(iii) requires each licensee to state in its FFD policies and
procedures the work hour counting system in Section 26.205(d)(7)(ii) the licensee is
using.
•
10 CFR 26.205(d)(8) requires each licensee to explicitly state in its FFD policies and
procedures the work hour control requirements with which it is complying: minimum
days off provisions of Section 26.205(d)(3) or maximum average work hour provisions of
Section 26.205(d)(7).
•
10 CFR 26.205(e) requires each licensee to evaluate the effectiveness of its control of
work hours for individuals who are subject to Subpart I, at a minimum of once per
calendar year. If any plant or security system outages or increased threat conditions
occurred since the licensee completed the most recent review, the licensee must include
in the review an evaluation of the control of work hours during the outages or the
increased threat conditions. The review must be completed within 30 days of the end of
the review period. Paragraphs 26.205(e)(1) and (e)(2) describe the topics that must be
included in the reviews.
•
10 CFR 26.205(e)(3) requires each licensee to document the methods used to conduct
reviews and the results of those reviews.
•
10 CFR 26.205(e)(4) requires each licensee to record, trend, and correct, under the
licensee’s corrective action program, any problems identified in maintaining control of
work hours consistent with the specific requirements and performance objectives of
Part 26.
10 CFR 26.207(a)(4) requires each licensee to document the bases for the issuance of
individual waivers. The documented basis for a waiver must include a description of the
circumstances that necessitated the waiver, a statement of the scope of work and time period
for which the waiver is approved, and the bases for the determinations. This requirement
ensures that waivers to the work hours controls are approved only by those supervisors and
shift managers authorized to determine if a waiver is necessary and that a record is created to
document the basis for the waiver and the identity of the person approving the waiver.
Recordkeeping requirements for Section 26.207 are established by Section 26.203(d)(3).
10 CFR 26.209 requires each individual subject to the rule to self-declare that he or she is
unable to safely and competently perform his or her duties due to fatigue, and for the licensee to
take certain actions if such a declaration is made.
10 CFR 26.211(f) requires each licensee to document the results of any fatigue assessments
conducted, the circumstances that necessitated the fatigue assessment, and any controls and
conditions that were implemented. This requirement ensures that fatigue assessments of
49
individuals are conducted in appropriate circumstances and in an appropriate manner. This
requirement ensures that the due process rights of individuals who are subject to the fatigue
management requirements are protected. It will support internal licensee self-assessments of
fatigue-management programs. This requirement also enables NRC to review and audit the
licensees’ and other entities’ fatigue management programs. Recordkeeping requirements for
Section 26.211(f) is established by Section 26.203(d)(5).
10 CFR 26.211(g) requires the licensee or other entity of each operating nuclear power reactor
site to prepare an annual summary detailing instances of fatigue assessments conducted during
the previous calendar year for individuals described in Section 26.4(a) through (c). Each
summary must include: the conditions under which each fatigue assessment was conducted
(e.g., self-declaration, for cause, post-event, or follow-up); a statement of whether or not the
individual was working on outage activities at the time of the self-declaration or condition
resulting in the fatigue assessment; the category of duties the individual was performing, if the
individual was performing the duties described in Section 26.4(a)(1) through (a)(5) at the time of
the self-declaration or condition resulting in the fatigue assessment; and the management
actions, if any, resulting from each fatigue assessment. This requirement ensures that licensees
and other entities provide information to the NRC to demonstrate their fulfillment of regulatory
requirements for fatigue management and to allow the NRC to assess the effectiveness of the
fatigue management requirements. Collection of this information pertaining to fatigue
assessments and the management actions, if any, resulting from fatigue assessments is
necessary to permit internal reviews and audits by licensees and to permit evaluation of events
and trends that might become problems and that may require action by the NRC staff to ensure
that the health and safety of the public is not endangered. The recordkeeping requirements for
Section 26.211(g) is established by Section 26.203(d)(5).
10 CFR 26.711(a) and (b). Although no records or reports are required by these two
paragraphs, they influence how the records and reports required by Part 26 will be created,
stored, and archived. This section provides licensees and other entities with the opportunity to
use electronic records and makes the requirements in Part 26 consistent with access
authorization requirements established in 10 CFR 73.56, orders issued to the licensees of
nuclear power plants on January 7, 2003, and subsequent rulemaking.
•
10 CFR 26.711(a) provides that each licensee and other entity shall maintain records
and submit certain reports to the NRC. Records that are required by the regulations in
Part 26 must be retained for the period specified by the appropriate regulation. If a
retention period is not otherwise specified, these records must be retained until the
Commission terminates the facility license, certificate, or other regulatory approval.
•
10 CFR 26.711(b) provides that each licensee and entity may store and archive records
electronically, provided that the record provides an accurate representation of the
original, cannot be altered once it has been committed to storage, and can be easily
retrieved and recreated.
10 CFR 26.711(c) provides that licensees and other entities specified in section 26.3(a) and as
applicable, Section 26.3(c) and (d), shall inform each individual of his or her right to review
information about the individual that is collected and maintained under Part 26 to assure its
accuracy. Licensees and other entities are required to provide individuals with an opportunity to
correct inaccurate or incomplete information that is maintained under Part 26. This paragraph
supplements the provisions in Section 26.37 relating to protection of information and makes
50
explicit that individuals can review and request that the licensee or other entity to correct any
inaccurate information identified.
10 CFR 26.711(d) provides that licensees and other entities shall ensure that only correct and
complete information about individuals is retained and shared with other licensees and entities.
If shared information changes or new information is developed, licensees and other entities are
required to correct or augment the shared information contained in the records. If the changed
or developed information has implications for adversely affecting an individual’s eligibility for
authorization, the licensee or other entity shall inform the reviewing official of any FFD program
under which the individual is maintaining authorization of the updated information on the day of
discovery. The reviewing official shall take appropriate actions, which may include denial or
unfavorable termination of the individual’s authorization. This paragraph ensures that incorrect
or incomplete information about individuals is corrected and that newly obtained information
relevant to the individual’s eligibility for authorization is shared with other FFD programs.
10 CFR 26.713(a)(1) – (a)(4), (b)(1) and (b)(2), and (c) – (g) ensure that licensees and other
entities collect and maintain records that demonstrate compliance with Part 26. These records
ensure that licensees and other entities can review and correct problems identified in
implementing FFD programs, and enables NRC inspection of FFD programs. This section
contains the majority of recordkeeping requirements in Part 26; however, the activities that
generate the records maintained under these requirements are located elsewhere.
•
10 CFR 26.713(a)(1) requires the retention of records of self-disclosures and suitable
inquiries conducted under sections 26.55, 26.57, 26.59, and 26.69 that result in the
granting of authorization for at least 5 years after the licensee or other entity terminates
or denies an individual’s authorization or until the completion of all related legal
proceedings, whichever is later.
•
10 CFR 26.713(a)(2) requires the retention of records pertaining to any determination of
a violation of the FFD policy and related management actions for at least 5 years after
the licensee or other entity terminates or denies an individual’s authorization or until the
completion of all related legal proceedings, whichever is later.
•
10 CFR 26.713(a)(3) requires the retention of records of documentation of the granting
and termination of authorization for at least 5 years after the licensee or other entity
terminates or denies an individual’s authorization or until the completion of all related
legal proceedings, whichever is later.
•
10 CFR 26.713(a)(4) requires the retention of records of any determinations of fitness
conducted under Section 26.189, including recommendations for treatment and followup testing plans, for at least 5 years after the licensee or other entity terminates or
denies an individual’s authorization or until the completion of all related legal
proceedings, whichever is later.
•
10 CFR 26.713(b)(1) requires that licensees and other entities retain records of FFD
training and examinations conducted under Section 26.29 for at least 3 years or until the
completion of all related legal proceedings, whichever is later.
51
•
10 CFR 26.713(b)(2) requires that licensees and other entities retain records of FFD
audits, audit findings, and corrective actions taken under Section 26.41 for at least
3 years or until the completion of all related legal proceedings, whichever is later.
•
10 CFR 26.713(c) requires that licensees and other entities to retain and make available
records pertaining to any 5-year denial of authorization under Section 26.75(c), (d), or
(e)(2), and any permanent denials of authorization under Section 26.75(b) and (g) for at
least 40 years or until, upon application, the NRC determines that the records are no
longer needed.
•
10 CFR 26.713(d) requires that licensees and other entities retain any superseded
versions of the written FFD policy and procedures required under sections 26.27, 26.39,
and 26.203(b) for at least 5 years or until completion of all legal proceedings related to
an FFD violation that may have occurred under the policy and procedures, whichever is
later.
•
10 CFR 26.713(e) requires that licensees and other entities retain written agreements for
the provision of services under Part 26 for the life of the agreement or until completion of
all legal proceedings related to an FFD policy violation that involved those services,
whichever is later.
•
10 CFR 26.713(f) requires that licensees and other entities retain records of the
background investigations, credit and criminal history checks, and psychological
assessments of FFD program personnel, conducted under Section 26.31(b)(1), for the
length of the individual’s employment by or contractual relationship with the licensee or
other entity, or until the completion of all related legal proceedings, whichever is later.
•
10 CFR 26.713(g) requires that if a licensee’s and other entity’s FFD program includes
tests for drugs in addition to those specified in Part 26, the licensee or other entity shall
retain the documentation certifying the scientific and technical suitability of the assays
and cutoff levels used, as required under Section 26.31(d)(1)(i) and (d)(3)(iii)(C)
respectively, for the period of time during which the FFD program follows those practices
or until the completion of all related legal proceedings, whichever is later.
10 CFR 26.715(a) establishes a 2-year retention period (or longer if related to a legal
proceeding) for the records generated by collection sites, LTFs and HHS labs that provide
services to a licensee’s or other entity’s D&A testing program. The retention period also may be
extended upon written notice from the NRC, or by the licensee or other entity for whom services
are provided.
10 CFR 26.715(b)(1) – (b)(14) describe the records that must be maintained pursuant to the
retention period in Section 26.715(a). These requirements ensure that records are maintained
by licensees and other entities that maintain collection sites and/or testing facilities, and by
laboratories certified by the HHS that provide services to licensees and other entities, that
demonstrate that D&A testing requirements are implemented properly. Such records are
generally consistent with the requirements for HHS labs in the HHS Guidelines, as well as with
usual and customary business practices for such laboratories. These records are also
necessary to enable licensees and other entities to review and correct any problems in
implementing FFD D&A testing programs, and to enable the NRC to inspect the licensees’ and
other entities’ D&A testing programs.
52
•
10 CFR 26.715(b)(1): Personnel files, including training records, for all individuals who
have been authorized to have access to specimens, but are no longer under contract to
or employed by the collection site, LTF, or HHS lab;
•
10 CFR 26.715(b)(2): Chain of custody documents (other than forms recording
specimens with negative test results and no FFD violations or anomalies, which may be
destroyed after appropriate summary information has been recorded for program
administration purposes);
•
10 CFR 26.715(b)(3): QA/QC records;
•
10 CFR 26.715(b)(4): Superseded procedures;
•
10 CFR 26.715(b)(5): All test data (including calibration curves and any calculations
used in determining test results);
•
10 CFR 26.715(b)(6): Test reports;
•
10 CFR 26.715(b)(7): Records pertaining to performance testing;
•
10 CFR 26.715(b)(8): Records pertaining to the investigation of testing errors or
unsatisfactory performance discovered in quality control or blind performance testing, in
the testing of actual specimens, or through the processing of appeals and MRO reviews,
as well as any other errors or matters that could adversely reflect on the integrity of the
testing process, investigation findings, and corrective actions taken, where applicable;
•
10 CFR 26.715(b)(9): Performance records on certification inspections;
•
10 CFR 26.715(b)(10): Records of preventative maintenance on LTF instruments;
•
10 CFR 26.715(b)(11): Records that summarize any test results that the MRO
determined to be scientifically insufficient for further action;
•
10 CFR 26.715(b)(12): Printed or electronic copies of computer-generated data;
•
10 CFR 26.715(b)(13): Records that document the dates, times of entry and exit,
escorts, and purposes of entry of authorized visitors, maintenance personnel, and
service personnel who have accessed secured areas of LTFs and HHS labs; and,
•
10 CFR 26.715(b)(14): Records of the inspection, maintenance, and calibration of EBTs.
10 CFR 26.717 (a), (b), (b)(1) – (b)(9), (c) – (g) establish the FFD program performance data
reporting requirements that each licensee or other entity must maintain and report to the NRC
on an annual basis. Preparation of the annual FFD program performance report enables each
licensee and other entity to review site performance and address issues, if noted. FFD program
performance reports provide the NRC with timely information on site-specific D&A testing
program performance to assess compliance with regulatory requirements. The NRC also
aggregates and evaluates FFD program performance data to identify adverse trends in
substance use that may require regulatory action, additional NRC evaluation through inspection,
or other oversight activities. NRC summarizes information from annual FFD program
53
performance reports and publishes a publically available report that informs the public and
regulated entities on performance trends. These site-specific annual reports also support NRC
evaluation of FFD programs through inspection. The information provided in annual
performance reports enables effective oversight of D&A testing programs to protect public
health and safety.
•
10 CFR 26.717(a) requires licensees and other entities to collect and compile FFD
program performance data.
•
10 CFR 26.717(b) describes the required data to be provided in each FFD program
performance report:
o
10 CFR 26.717(b)(1): The random testing rate;
o
10 CFR 26.717(b)(2): Drugs tested for and cutoff levels, including results of tests
using lower cutoff levels, tests for drugs not included in the HHS panel, and tests
of dilute specimens tested at the LOD;
o
10 CFR 26.717(b)(3): Populations tested (i.e., individuals in applicant status,
permanent licensee employees, C/Vs);
o
10 CFR 26.717(b)(4): Number of tests administered and results of those tests
sorted by population tested (i.e., individuals in applicant status, permanent
licensee employees, C/Vs);
o
10 CFR 26.717(b)(5): Conditions under which the tests were performed;
o
10 CFR 26.717(b)(6): Substances identified;
o
10 CFR 26.717(b)(7): Number of subversion attempts by type;
o
10 CFR 26.717(b)(8): Summary of management actions; and
o
10 CFR 26.717(b)(9): Information on fatigue management programs required
under section 26.203(e)(1) and (e)(2).
•
10 CFR 26.717(c) requires any licensee or other entity who has a licensee-approved
FFD program to analyze FFD program performance data at least annually and to retain
records of the data, analyses, and corrective actions taken for at least 3 years or until
the completion of any related legal proceedings, whichever is later.
•
10 CFR 26.717(d) requires that if a licensee or other entity terminates an individual’s
authorization or takes administrative action on the basis of initial drug testing positive
results for marijuana or cocaine at an LTF, it must report those test results in the annual
FFD program performance report. Test results must be provided by processing stage
(i.e., initial testing at the LTF, testing at the HHS lab, and MRO determinations), and
include the number of terminations and administrative actions taken.
•
10 CFR 26.717(e) requires licensees and other entities to submit the FFD program
performance data (for January through December) to the Commission annually, before
March 1 of the following year.
54
•
10 CFR 26.717(f) permits licensees and other entities to submit FFD program
performance data in a consolidated report, if the report presents the data separately for
each site.
•
10 CFR 26.717(g) specifies that each C/V who maintains a licensee-approved D&A
testing program is subject to the reporting requirements of Section 26.717 and shall
submit the required information either directly to the NRC or through the licensee(s) or
entities to whom the C/V provided services during the year. Licensees, C/Vs, and other
entities are required to share information to ensure that the information is reported
completely and is not duplicated in reports submitted to the NRC.
10 CFR 26.719(a), (b), (b)(1) – (b)(4), (c)(1) – (c)(3), and (d) ensure that licensees and other
entities subject to Part 26 to provide timely information on significant violations of FFD policy,
testing errors, and other events affecting FFD program performance to the NRC. These reports
ensure that licensees and other entities review and correct any problems in implementing FFD
programs, and enables NRC action to assess these events prior to periodic inspections, and to
take appropriate action, as needed, to protect public health and safety, and the common
defense and security.
•
10 CFR 26.719(a) requires licensees and entities to inform the NRC of significant
violations of the FFD policy, significant FFD program failures, and errors in D&A testing,
and to report under Section 26.719 rather than Section 73.71.
•
10 CFR 26.719(b) requires licensees and other entities report the following significant
violations of the FFD policy and significant FFD program failures to the NRC Operations
Center by telephone within 24 hours after the licensee or other entity discovers the
violation:
•
o
10 CFR 26.719(b)(1): The use, sale, distribution, possession, or presence of
illegal drugs, or the consumption or presence of alcohol within a protected area.
o
10 CFR 26.719(b)(2): Any act by a person licensed under 10 CFR Parts 52 to
operate a nuclear power reactor, SSNM transporters, FFD program personnel, or
supervisory personnel authorized under Part 26 if such acts: (i) involve the use,
sale, or possession of a controlled substance; (ii) result in a determination that
the individual has violated the licensee’s or other entity’s FFD policy; or
(iii) involve the consumption of alcohol within a protected area or while
performing required duties.
o
10 CFR 26.719(b)(3): Any intentional act that casts doubt on the integrity of the
FFD program; and,
o
10 CFR 26.719(b)(4): Any programmatic failure, degradation, or discovered
vulnerability of the FFD program that may permit undetected drug or alcohol use
or abuse by individuals within a protected area, or by individuals assigned to
perform duties that require them to be subject to the FFD program.
10 CFR 26.719(c)(1) requires that a licensee or other entity submit to the NRC a report
within 30 days of completing an investigation of any LTF or HHS lab testing error or
unsatisfactory performance issue. These performance issues could be discovered during
55
performance testing, testing of specimens (quality control or donor), or through the
reviews completed under sections 26.39 and 26.185, and can include any other errors or
matters that could adversely reflect on the integrity of the random selection or testing
process. The report is required to include a description of the incident and corrective
actions taken or planned. If the error involves an HHS lab, the NRC shall ensure that
HHS is notified of the finding.
•
10 CFR 26.719(c)(2) requires that a licensee or other entity notify the NRC within
24 hours following discovery of a false positive error for the testing of a BPTS at an
HHS-certified laboratory.
•
10 CFR 26.719(c)(3) requires that a licensee or other entity notify the NRC within
24 hours following discovery of a false negative error on a QA check of validity screening
tests required by Section 26.137(b).
•
10 CFR 26.719(d) requires that a licensee or other entity document, trend, and correct
non-reportable indicators of FFD programmatic weaknesses under the licensee’s or
other entity’s corrective action program, but prohibits the tracking or trending of D&A test
results in a manner that permits the identification of any individuals.
10 CFR 26.821(a) requires licensees and other entities to permit NRC-authorized
representatives to inspect, copy, or take away copies of its records and to inspect its premises,
activities, and personnel as may be necessary to accomplish the purposes of Part 26. This
requirement enables the NRC to obtain copies of documents for additional review and analysis
at NRC offices. Copies of records enable the NRC to evaluate FFD program performance and
to verify compliance with Part 26 requirements.
10 CFR 26.821(b) requires licensees and other entities to enter into written agreements with
their C/Vs that permit duly authorized NRC representatives to inspect, copy, or take away
copies of the C/V’s documents, records, and reports related to implementation of the licensee’s
or other entity’s FFD program under the scope of the contracted activities. This requirement is
necessary because C/Vs may administer components of the licensee’s or other entity’s FFD
program or may have its own FFD program pertaining to their employees who work under
contract to licensees or other entities in situations in which they are subject to FFD
requirements. This requirement is necessary to enable the NRC to obtain copies of documents
for additional review and analysis at the offices of the NRC and for the development of a written
record on topics involving Part 26. Such copies of records may be necessary to enable the NRC
to evaluate the C/Vs’ FFD programs and to obtain information necessary to develop public
policy. The recordkeeping requirement for Section 26.821(b) is established by
Section 26.713(e).
As a result of this proposed change, the following information collections that are PDF electronic
reporting forms covered by OMB Clearance 3150-0146 also would no longer apply to Part 52
licensees after the NRC has docketed their Section 52.110(a) certifications:
•
•
•
NRC Form 890 – Single Positive Test Form
NRC Form 891 – Annual Reporting Form for Drug and Alcohol Tests
NRC Form 892 – Annual Fatigue Reporting Form
56
NRC Forms 890, 891 and 892 provide a voluntary means of reporting information required
under Section 26.717 for D&A testing programs and Section 26.203(e) for fatigue management
programs.
| File Type | application/pdf |
| File Modified | 2022-03-02 |
| File Created | 2022-03-02 |