ML092460031

Notice of Public Meeting to Discuss Draft Regulatory Issue Summary for Test Controls Associated with Performing Initial Validity Tests and Drug Tests Described in 10 CFR Part 26, Subpart F - Enclosure 1

ML092460031
Person / Time
Issue date:	09/03/2009
From:	Office of Nuclear Security and Incident Response
To:
Paul Harris, NRR/PMDA/FMB,301-415-1169
Shared Package
ML092460026	List: ML092460031
References
RIS-09-008
Download: ML092460031 (5)

See also: RIS 2009-08

Text

UNITED STATES

NUCLEAR REGULATORY COMMISSION

OFFICE OF NUCLEAR REACTOR REGULATION

WASHINGTON, DC 20555-0001

Sept XX, 2009

NRC REGULATORY ISSUE SUMMARY 2009-08

PROCESS FOR TEST CONTROLS ASSOCIATED WITH PERFORMING INITIAL VALIDITY

TESTS AND DRUG TESTS DESCRIBED IN

10 CFR PART 26, SUBPART F

ADDRESSEES

All holders of operating licenses for nuclear power reactors under the provisions of Title 10 of

the Code of Federal Regulations (10 CFR) Part 50, Domestic Licensing of Production and

Utilization Facilities, except those who have permanently ceased operations and have certified

that fuel has been permanently removed from the reactor vessel.

All holders of nuclear power plant construction permits and early site permits with a limited work

authorization (LWA) and applicants for nuclear power plant construction permits that have an

LWA under the provisions of 10 CFR Part 50, Domestic Licensing of Production and Utilization

Facilities.

All holders of a combined license (COL) for a nuclear power plant under the provisions of

10 CFR Part 52, Licenses, Certifications, and Approvals for Nuclear Power Plants, and

applicants for a COL that have an LWA.

All licensees who are authorized to possess, use, or transport formula quantities of strategic

special nuclear material under the provisions of 10 CFR Part 70, Domestic Licensing of Special

Nuclear Material.

All holders of a certificate of compliance or an approved compliance plan under the provisions of

10 CFR Part 76, Certification of Gaseous Diffusion Plants, if the holder engages in activities

involving formula quantities of strategic special nuclear material.

All contractors and vendors (C/Vs) who implement fitness-for-duty (FFD) programs or program

elements to the extent that the licensees and other entities listed above rely on those C/V FFD

programs or program elements to comply with 10 CFR Part 26, Fitness For Duty Programs.

INTENT

The U.S. Nuclear Regulatory Commission (NRC) is issuing this Regulatory Issue Summary

(RIS) to inform stakeholders that the NRC has issued an Enforcement Guidance Memorandum

(EGM) dispositioning violations of certain NRC requirements for initial validity tests and drug

tests. This RIS requires no action or written response on the part of an addressee.

Enclosure 1

RIS 2009-08

Page 2 of 5

BACKGROUND INFORMATION

In August 2005, the NRC proposed amendments to 10 CFR Part 26, in part, to improve the

effectiveness and efficiency of FFD programs and enhance consistency with U.S. Department of

Health and Human Services (HHS) Mandatory Guidelines for Federal Workplace Drug Testing

Programs (HHS Guidelines). The NRC requires licensees and other entities that are subject

to 10 CFR Part 26 to use only HHS-certified laboratories to perform certain types of drug

testing. On March 31, 2008, the Commission issued a final rule amending Part 26

(73 FR 16966). Licensees and other entities were required to implement all provisions of the

rule by March 31, 2009, except for Subpart I, Managing Fatigue, which must be implemented

no later than October 1, 2009.

The NRC utilizes HHS established technical requirements for various drug testing activities and

has only deviated from the HHS Guidelines for considerations that are specific to the nuclear

industry. For example, unlike the HHS Guidelines, 10 CFR Part 26 allows the establishment of

onsite licensee testing facilities (LTFs) for the conduct of initial drug and validity tests of urine

specimens to detect whether certain individuals may have engaged in substance abuse.

Subpart F, Licensee Testing Facilities, of 10 CFR Part 26 includes the requirements for LTFs.

If the results of initial drug and validity tests at an LTF indicate that an individual may have

engaged in substance abuse or attempted to tamper with his or her specimen in an effort to

conceal substance abuse, licensees are required to submit the individuals specimen to an

HHS-certified laboratory for supplemental testing. Requirements for testing these specimens at

the HHS-certified laboratories are contained in Part 26, Subpart G, Laboratories Certified by

the Department of Health and Human Services.

SUMMARY OF ISSUE

On February 24, 2009, the NRC conducted a public meeting (Agencywide Documents Access

and Management System (ADAMS) Accession Nos. ML090420577 and ML090771060) with

industry representatives and members of the public to discuss issues related to 10 CFR Part 26

and the HHS Guidelines. On March 13, 2009, the Nuclear Energy Institute (NEI), on behalf of

the nuclear power industry, requested enforcement discretion (ADAMS Accession No.

ML090780477) for 10 CFR 26.137(d)(5) and 10 CFR 26.137(e)(6)(v). NEI stated, in part, that

these two requirements of the final rule, compared to the related text of the former

(54 FR 24494; June 7, 1989, as amended) and proposed (70 FR 50442; August 25, 2005) rules,

would cause licensees and other entities that operate LTFs to incur unnecessary burden and

cost to meet the requirements of the final rule.

The NRC reviewed the NEI request and found that the language in the subject requirements

does not accurately reflect the testing requirements necessary for LTFs and as described in the

former and proposed rules. The NRC also found that these inaccuracies, if left uncorrected,

would result in an unnecessary regulatory burden on licensees and other entities that operate

LTFs. The NRC issued EGM-09-003, dated March 31, 2009, to grant enforcement discretion for

the affected requirements. The NRC conducted public meetings on February 24, and June 24,

2009, to discuss these requirements with the public. The summaries of these meetings can be

viewed at the NRCs Agencywide Documents Access and Management System (ADAMS)

RIS 2009-08

Page 3 of 5

utilizing accession number ML090771060 and ML091910511, respectively. The NRC will also

continue its interaction with the public and industry to evaluate 10 CFR Part 26 requirements.

Evaluation of Issue

When responding to public comments on the August 2005, proposed amendments to 10 CFR Part 26, the NRC inadvertently transposed quality control (QC) requirements that are

appropriate for HHS-certified laboratories, as specified in Subpart G of the final rule, into

Subpart F regulations applicable to LTFs. As described in EGM-09-003, the incorrect language

in the final rule and the correct requirements are provided below. The underlined sections are

provided to illustrate substantive differences. NRC evaluation of these differences follows.

10 CFR 26.137(d)(5)

Incorrect Each analytical run performed to conduct initial validity testing shall include at

least one quality control sample that appears to be a donor specimen to the

laboratory analysts.

Correct Each analytical run performed to conduct initial validity testing shall include at

least one quality control sample that appears to be a normal specimen to the

licensee testing facility technicians.

10 CFR 26.137(e)(6)(v)

Incorrect At least one positive control, certified to be positive by an HHS-certified

laboratory, that appears to be a donor specimen to the laboratory analysts.

Correct At least one quality control sample that appears to be a normal specimen to the

licensee testing facility technicians.

Use of the term laboratory analysts in Subpart F, rather than licensee testing facility

technicians, is inconsistent with the terminology used throughout the remainder of the rule

(e.g., Subpart G). The position description laboratory analysts used in Subpart G refers to

HHS-certified laboratory analysts who must be trained and qualified to perform more

sophisticated and complex confirmatory tests than those performed at LTFs. By using the term

laboratory analyst in Subpart F, rather than licensee testing facility technician, the rule

inadvertently imposes unnecessary and unduly burdensome training and qualification

requirements on licensees.

Use of the phrase donor specimen, rather than normal specimen, is inconsistent with the

intent of the rule. If the specimen were required to be a donor specimen, licensees would then

be required to assign the roles of specimen collector and LTF technician to different persons,

which is not required for initial validity and drug tests performed at LTFs. If left uncorrected, the

final rule would represent an unnecessary cost and burden on licensees because procedure

changes would be necessary and an additional trained and qualified person would be required

to implement these tests. The majority of LTFs utilize a single LTF technician to perform

specimen testing. That practice is consistent with the former and proposed rules and the intent

of the final rule.

RIS 2009-08

Page 4 of 5

The language in 10 CFR 26.137(e)(6)(v) will prevent licensees from using the same QC sample

to test both the accuracy of testing and implementation of custody-and-control procedures. The

former and proposed rules did not require a specimen that appears to be a normal specimen

to be certified by an HHS-certified laboratory to be a positive QC sample (i.e., a sample that

contains drugs or drug metabolites at a concentration that exceeds the applicable cutoff levels

for initial drug tests in 10 CFR Part 26). Requirements for positive QC samples are addressed

in other provisions of this same section of the rule. Furthermore, the former and proposed rules

permitted this sample to be negative or to have positive characteristics to evaluate the accuracy

of licensee testing procedures and equipment. This flexibility is appropriate and consistent with

the intent of the final rule.

EGM-09-003 provides enforcement discretion for licensee compliance with 10 CFR 26.137(d)(5)

and 10 CFR 26.137(e)(6)(v). As detailed in the EGM, licensees shall continue to meet the

requirements of the former rule for the subject initial drug and validity testing requirements as

described in Sections 2.7 and 2.8 of Appendix A of the former rule. Licensees may elect to

voluntarily comply with the final rule.

BACKFIT DISCUSSION

This RIS is being issued to inform stakeholders that the NRC has issued an EGM dispositioning

violations of certain 10 CFR Part 26 requirements for initial drug and validity tests performed at

LTFs. The NRC is not imposing or requiring any new positions on licensees. The RIS does not

require licensees to change or modify procedures or processes. Any action on the part of

addressees in response to the information in this RIS is strictly voluntary. Therefore, pursuant

to 10 CFR 50.109, Backfitting, the backfit rule does not apply and a backfit analysis is not

required.

FEDERAL REGISTER NOTIFICATION

The NRC did not publish a notice of opportunity for public comment on this RIS in the Federal

Register because this RIS is informational. Furthermore, although this RIS refers to a departure

from regulatory requirements detailed in an EGM, it does not impose new or more stringent

requirements.

On February 24, 2009, the NRC conducted a public meeting (ADAMS Accession Nos.

ML090420577 and ML090771060) and met with industry representatives and members of the

public to discuss issues related to 10 CFR Part 26 and the HHS Guidelines. The NRC intends

to continue working with industry representatives, members of the public, and other

stakeholders in its consideration of proposed rulemaking related to these matters.

CONGRESSIONAL REVIEW ACT

The RIS is not a rule as designated by the Congressional Review Act (5 U.S.C. 801-808) and

therefore is not subject to the Act.

RIS 2009-08

Page 5 of 5

PAPERWORK REDUCTION ACT

This RIS does not contain information collection requirements that are subject to the Paperwork

Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

PUBLIC PROTECTION NOTIFICATION

The NRC may not conduct or sponsor, and a person is not required to respond to a request for

information or an information collection requirement unless the requesting document displays a

currently valid U.S. Office of Management and Budget clearance number.

CONTACTS

Please direct any questions about this matter to the technical contact listed below or to the

appropriate NRC project manager.

Timothy J. McGinty, Director

Division of Policy and Rulemaking

Office of Nuclear Reactor Regulation

Technical Contact: Paul W. Harris, NSIR/DSP

301-415-1169

Paul.Harris@nrc.gov

Note: NRC generic communications may be found on the NRC public Web site,

http://www.nrc.gov, under Electronic Reading Room/Document Collections.