This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

21105

Vol. 61, No. 91

Thursday, May 9, 1996

NUCLEAR REGULATORY

COMMISSION

10 CFR Part 26

RIN 3150–AF12

Modifications to Fitness-For-Duty

Program Requirements

AGENCY: Nuclear Regulatory

Commission.

ACTION: Proposed rule.

SUMMARY: The Nuclear Regulatory

Commission (NRC) proposes to amend

its regulations to modify the current

Fitness-For-Duty Program (FFD)

requirements. The proposed

amendments would apply to all

licensees authorized to construct or

operate a nuclear power reactor and all

licensees authorized to possess or

transport Category I nuclear material.

The proposed rule is intended to ensure

compatibility with changes made to the

Department of Health and Human (HHS)

testing guidelines, reduce unnecessary

burdens, and ensure continued

protection of public health and safety.

The NRC specifically requests

comments on a number of issues and, in

particular, as to whether the changes

would provide a substantial increase in

the overall protection of the public

health and safety and the common

defense and security, whether the rule

as whole does not constitute a backfit

since the rule’s cumulative effect is to

ease licensee burdens or leave them

essentially the same, whether those

subject to the rule would not object to

the new requirements in view of their

perception of overall benefit and, if so,

whether their non-objection could be

grounds for not applying the backfit

rule.

DATES: The comment period expires

August 7, 1996. Comments received

after this date will be considered if it is

practical to do so, but the Commission

is able to assure consideration only for

comments received on or before this

date.

ADDRESSES: Mail comments to: The

Secretary of the Commission, U.S.

Nuclear Regulatory Commission,

Washington, DC 20555, ATTN:

Docketing and Service Branch.

Deliver comments to: One White Flint

North, 11555 Rockville Pike, Rockville,

Maryland between 7:30 am and 4:15 pm

on Federal workdays.

Copies of the draft regulatory analysis,

comments received, the Americans With

Disabilities Act Technical Assistance

Manual, HHS’s Medical Review Officer

Manual, and NIDA’s Technical

Advisory of March 11, 1991, may be

examined at: the NRC Public Document

Room, 2120 L Street, NW. (Lower

Level), Washington, DC.

Copies of NUREG/CR–5784, ‘‘Fitness

for Duty in the Nuclear Power Industry:

A Review of the First Year of Program

Performance and an Update of the

Technical Issues,’’ NUREG–1385,

‘‘Fitness for Duty in the Nuclear Power

Industry: Responses to Implementation

Questions,’’ and NUREG/CR–5758,

‘‘Fitness for Duty in the Nuclear Power

Industry: Annual Summary of Program

Performance Reports,’’ CY 1994,

Volume 5, may be purchased from the

Superintendent of Documents, U.S.

Government Printing Office, P.O. Box

37082, Washington, DC 20402–9328.

Copies are also available from the

National Technical Information Service,

5282 Port Royal Road, Springfield, VA

22161. A copy is available for

inspection and/or copying in the NRC

Public Document Room, 2120 L Street,

NW. (Lower Level), Washington, DC.

FOR FURTHER INFORMATION CONTACT:

Loren L. Bush, Jr., Office of Nuclear

Reactor Regulation, U.S. Nuclear

Regulatory Commission, Washington,

DC 20555. Telephone: (301) 415–2944.

SUPPLEMENTARY INFORMATION:

Background

The NRC is proposing to amend its

regulations on ‘‘Fitness-for-Duty

Programs,’’ as part of its ongoing

activities to improve its regulations.

The objective of the licensee’s fitnessfor-duty program is to provide

reasonable assurance that nuclear power

plant personnel are reliable,

trustworthy, and not under the

influence of any substance, legal or

illegal, or mentally or physically

impaired from any cause, which in any

way adversely affects their ability to

safely and competently perform their

duties. Fitness-for-duty programs

developed under the requirements of 10

CFR Part 26 are intended to create an

environment which is free of drugs and

the effects of such substances.

In its deliberation of the many issues

associated with the rulemaking, the

Commission desired that the rule ensure

a proper balance between safeguarding

individual rights and the Commission’s

responsibility to protect public health

and safety. The changes proposed in

this rulemaking are intended to be

consistent with the Commission’s

original goals and to ensure there is a

proper balance between the

Commission’s responsibility for

protecting the public health and safety

and its interest in protecting individual

employee rights from unconstitutional

invasion of their right to privacy.

The NRC has reviewed the experience

gained since publication of the rule on

June 7, 1989 (54 FR 24468), which was

implemented by licensees January 3,

1990. NRC review included information

from several sources, such as

inspections, periodic reports by

licensees on program performance,

reports of significant FFD events,

industry-sponsored meetings, initiatives

by the Nuclear Management and

Resources Council (NUMARC) (now the

Nuclear Energy Institute) and the

Substance Abuse and Mental Health

Services Administration (SAMHSA)

(formerly the National Institute on Drug

Abuse [NIDA]) and its Drug Testing

Advisory Board, and current literature.

The review indicates that, although the

rule is fundamentally sound and

provides a means for deterrence and

detection of substance abuse, some

matters need to be addressed. These

matters include the—

(1) Need to ensure compatibility with

changes made to the HHS guidelines;

(2) Reduction of burden on licensees

while fulfilling the purpose of the rule;

(3) Need for a limited number of new

requirements, e.g., to further reduce the

potential for subversion of the testing

process and to make clear that the

appeal process applies to all persons

covered by the rule; and

(4) Need to clarify the Commission’s

original intent in several areas to reduce

incorrect or inconsistent use and

differing interpretations and to make a

number of administrative changes.

While none of the proposed

amendments represent major changes,
21106 Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules

they do represent modifications that

would substantially reduce the cost of

implementation to licensees; enhance

overall program integrity, effectiveness,

and efficiency; and help to ensure the

continued protection of public health

and safety.

Discussion

The proposed amendments take into

account the experience gained in

implementing the initial rule,

developments in the FFD area, and

actions by other Government agencies

on drug testing and other FFD concerns.

During implementation of new

regulations, particularly regulations in

rapidly evolving disciplines such as

drug testing and employee reliability, a

substantial number of lessons are

learned from experience. The first five

years of experience with the NRC’s

fitness-for-duty rule are no exception. A

significant number of the proposed

revisions are adjustments to the rule

that would decrease the burden on

licensees without reducing the

protection of public health and safety

afforded by the rule. For example, one

proposed revision would allow

licensees to grant unescorted access to

personnel covered by another licensee’s

FFD program. This would facilitate

interchange of employees in, for

example, ‘‘peer evaluator’’ situations.

Another proposed revision of this type

would permit licensees to accept

generic portions of training provided by

another licensee to people covered by

the rule. This revision would recognize

that significant portions of all licensees’

fitness-for-duty training cover the same

general subjects and would facilitate

more timely contractor support during

outages.

While some proposed revisions would

increase program efficiency, others

would ensure that the Commission’s

FFD program more effectively achieves

its objectives. For example, the

Commission is proposing several

revisions to the rule’s drug and alcohol

testing requirements that would clarify

testing processes and purposes. While

many of these rule changes would

strengthen testing requirements, others

would reduce the testing burden on

licensee and contractor employees.

These and other revisions would bolster

the rule’s protection of public safety

while reducing the industry’s regulatory

burden where possible.

The NRC is also proposing a

substantial number of revisions to

respond to legal and regulatory changes

that have occurred since the publication

of 10 CFR Part 26. For example, the

Department of Transportation (DOT)

and its operating administrations (e.g.,

the Federal Aviation Administration

(FAA), the Federal Railroad

Administration (FRA), and the Federal

Highway Administration (FHA)) and

other Federal and State agencies have

expanded their drug and alcohol testing

requirements during the past five years.

Some of these regulatory changes have

created requirements applicable to some

licensee employees and contractors that

duplicate the NRC’s drug and alcohol

testing requirements. To reduce

unnecessarily duplicative burdens, the

Commission is proposing to permit

testing performed under these other

programs to be accepted in lieu of 10

CFR Part 26 testing when individuals

covered by an NRC program are also

subject to another program. Another

change since the publication of 10 CFR

Part 26 has been the implementation of

the requirements of the Americans with

Disabilities Act (ADA). While the ADA

specifically exempts the NRC’s program

from certain requirements, various

proposed revisions to the regulation

accommodate certain aspects of the Act.

For example, the current rule requires

licensees to determine whether

unescorted access to protected areas and

other activities specified in 10 CFR 26.2

have ever been denied to people seeking

unescorted access because of substance

abuse and related activities. This section

would be revised to limit such inquiry

to events that may have occurred during

only the previous five years.

During the first years of FFD rule

implementation a number of

requirements have been found to be

ambiguous and therefore subject to

inconsistent application by licensees.

These ambiguities have been costly to

licensees and NRC staff as they have

required a substantial number of

discussions involving licensee FFD

staff, attorneys, and consultants; NRC

inspectors; and NRC headquarters staff.

Although these ambiguities have

already been clarified for many licensee

programs, the NRC is proposing

revisions that would clarify the

Commission’s intent and help ensure

that the regulation is consistently

implemented, inspected, and enforced

throughout the industry. Increased

consistency of rule application

throughout the industry will benefit

licensees and their employees by

reducing the chances of arbitrary or

discriminatory application of the rule.

Finally, there are a number of

proposed revisions that would improve

the clarity of the rule. For example,

several terms regarding the testing

process and testing results have been

more carefully defined and consistently

used to eliminate difficulties in

interpretation.

In considering the actions to be taken,

the NRC will continue to consider the

proper balance between safeguarding an

individual’s rights and protecting public

health and safety.

In proposing these FFD rule revisions,

the NRC also notes that it is continuing

to move toward a performance-based

regulatory approach in most of its rule

making. Performance-based regulations

are intended to give regulated entities

clear guidance as to the objective of

those regulations but not to be overly

prescriptive in mandating specific

means by which those entities must

achieve the objectives. In taking this

approach, the Commission expects to

promote efficiencies in nuclear facility

operations while maintaining the

highest standards of public health and

safety. Both NRC policy and

Congressional directives emphasize the

need for the Commission to move

toward performance-based regulation.

While some of the proposed FFD rule

revisions reflect this performance-based

philosophy—most notably the increased

licensee discretion incorporated into

§ 26.80 auditing requirements—the

somewhat prescriptive nature of the

current 10 CFR Part 26 (particularly of

Appendix A), and many of the proposed

revisions, are a partial departure from

that regulatory approach. The NRC

believes that several characteristics of

and issues associated with fitness-forduty programs make it necessary for the

Commission to continue to provide

detailed directives in this particular

context. A relatively more specific

regulatory approach, for example, will

continue to assure that state and local

restrictions will not hinder the stringent

drug and alcohol testing needed to

assure that personnel covered by the

rule will continue to safely and

competently perform their duties. If the

NRC’s requirements are not clearly

stated in the rule, some state and local

laws would prohibit licensees from

implementing key program elements,

thus making complete achievement of

the rule’s performance objectives

difficult or impossible. The NRC

believes that it must maintain the

specificity of this rule in order to clearly

preempt such state and local laws that

could otherwise apply to licensees’

fitness-for-duty programs.

The rule’s specificity also protects the

rights of personnel subject to the rule’s

mandates. Many of the rule’s detailed

requirements address the need to assure

that testing is performed in a highly

reliable manner and that workers are not

wrongly accused due to false positive

test results. Many of these details

address these concerns and have served

to provide high confidence that false
Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules 21107

positives will not be obtained. While

protecting workers against unwarranted

damage to their careers in this way,

these detailed requirements provide

quality controls that also assure

accurate, valid, and dependable test

results. This, in turn, bolsters FFD

program credibility and acceptance

among workers. The specific provisions

in the rule have assured workers who do

not abuse drugs or alcohol that FFD

program requirements are administered

fairly and competently and that their

fellow workers who do violate FFD

policy will likely be detected and

removed from duty.

The rule’s specificity has also

benefited licensees during the first five

years of the rule’s implementation. This

specificity has, for example, helped

assure that positive test results can be

more easily defended when challenged

in court and during unemployment

proceedings. They have also provided a

clear statement of the NRC’s position for

licensees and labor representatives to

use when negotiating FFD-related issues

in collective bargaining agreements. The

introduction of drug testing and related

fitness-for-duty program requirements

into the workplace is a mandatory issue

for collective bargaining under the

National Labor Relations Act. A

prescriptive fitness-for-duty rule enables

licensees and labor representatives to

more effectively achieve the NRC’s

program objectives by clearly showing

that the NRC requires particular

program elements to be implemented in

specific ways.

Like the NRC, other Federal and state

agencies have also found it necessary to

establish specific requirements rather

than adopt a more performance-based

approach to assuring worker fitness. For

example, the detailed nature of the

NRC’s FFD rule is matched by the drug

use and alcohol abuse prevention rules

promulgated by the DOT and its five

operating administrations. The level of

detail of the HHS requirements for the

testing of Federal workers is also

comparable to that provided by Part 26.

The experience of these agencies bears

out the need for relatively specific

regulations in this workplace fitness

context.

The NRC seeks public comment on

the following issues. Public comments

should be submitted to the NRC as

indicated under the heading ADDRESSES.

1. Would any of the proposed

changes, group of related requirements

(e.g., modifications to prevent

subversion of the testing process, further

ensure the accuracy and integrity of

testing, clarify actions for removal), or

the rulemaking as a whole provide a

substantial increase in the overall

protection of the public health and

safety or the common defense and

security? Are the groupings and

subgroupings of the changes contained

in the Backfit Analysis section of this

Federal Register notice appropriate and

are the changes categorized properly?

Are the changes in Group III worthwhile

and necessary to better accomplish the

FFD rule’s objective, clarify the rule’s

existing requirements, and reduce

ambiguities. Does the rule as a whole

not constitute a backfit since the rule’s

cumulative effect is to ease licensee

burdens or leave them essentially the

same, rather than to increase them. Does

anyone subject to the rule not object to

the new requirements in view of their

perception of an overall benefit and, if

so, would their non-objection be

grounds for not applying the backfit

rule? Although the NRC believes that

the proposed specific changes to the

fitness-for-duty rule (FFD) would be the

most efficient method of accomplishing

the regulatory objectives of the changes,

are there any viable alternative

approaches that should be considered,

particularly with respect to the

proposed changes in Group III B? Could

the rule be less specific in stating the

requirements? The staff’s analysis of

alternative approaches such as

development of a Regulatory Guide,

NUREG good practices, meetings with

licensees, or industry initiatives, is

contained in the draft Regulatory

Analysis.

2. Should the NRC revise Appendix A

to 10 CFR Part 26 to incorporate

revisions to the Mandatory Guidelines

for Federal Workplace Drug Testing

Programs recently adopted by the

Department of Health and Human

Services (HHS) (June 9, 1994; 59 FR

29908)? The Commission proposes

adoption of the changes to the HHS

guidelines. In most instances, the HHS

guidelines have been adopted as

published by HHS; however, in some

cases modifications are proposed to

allow compatibility within the

framework of the original FFD rule (e.g.,

on-site testing provisions dictated

differences in minimum specimen

volume, minimum number of blind

performance specimens, on-site

determination of the validity of

specimens). The NRC desires to be

consistent with the HHS Guidelines,

absent a compelling reason why a

departure is necessary.

3. With respect to the discussion of

the proposed changes to § 26.24, are

there any alternative techniques for

testing for alcohol that should be

considered for adoption by the NRC?

4. During the past five years of

program operations, several parties have

recommended that the NRC consider

obtaining certain types of information in

addition to that currently required to be

submitted under the provisions of

§ 26.71(d). They believe that the

Commission could use such information

to better manage its FFD program

oversight responsibilities, which

includes formulation of public policy.

The specific additional types of

information and their potential use by

the NRC are described in the discussion

of proposed revisions to § 26.71 but are

not incorporated into the proposed

changes to the text of the rule. The NRC

requests public comment on whether

the licensees should be required to

collect, analyze, and submit to the NRC

such additional types of information.

5. The NRC is proposing to add a new

Section 2.7(e) to Appendix A that would

require testing to determine specimen

validity (i.e., detect evidence of

adulteration or dilution) before

performing a screening test on site (if

appropriate) and at the HHS laboratory.

This would be an adaptation of a change

HHS made to its guidelines in June,

1994. However, not all dilute specimens

are the result of attempts to avoid

detection. Hence, to minimize the

probability of incorrect conclusions

from such events, suspect specimens,

including those with abnormal specific

gravity (SG) would be subject to

screening and confirmation testing

using the limit of detection that the

laboratory is capable of performing. The

Commission requests comments

regarding this change, and, in addition,

requests comments on three other

revisions to detect evidence of

adulteration or dilution that are under

consideration:

a. Including Ph and/or creatinine as

well as SG in the required testing to

determine specimen validity;

b. Requiring tests to determine

specimen validity (which might include

SG, Ph, and/or creatinine) immediately

after specimen collection at all sites and

immediate collection of a second

specimen from those individuals

providing specimens with abnormal

qualities; and

c. Requiring tests at one-half of the

cut-off levels specified for each drug

instead of at the HHS-certified

laboratory’s limit of detection for

suspect specimens.

6. With respect to the discussion of

the proposed changes to Section 2.7 of

Appendix A:

a. Should the NRC require tests for

agents that can be added to urine as an

attempt to mask THC (marijuana) or

other drugs?

b. Should the NRC raise the cutoff

levels for screening and confirmation
21108 Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules

tests for opiates to reduce the

laboratory-confirmed positives for

opiates that the medical review officer

(MRO) determines to be negative? Given

the high level of concern for safety in

the nuclear industry, should the NRC

retain the current levels, even if HHS

should raise the levels for ‘‘demand

reduction’’ programs covered by its

Guidelines as it proposed on November

16, 1995 (60 FR 57587).

7. A key element of assuring the

integrity of the testing program is the

continued assurance of test accuracy

through licensees’ submission of blind

performance test specimens to HHScertified laboratories as required by

Section 2.8(e) of Appendix A. The NRC

has received a number of suggestions

regarding improving these blind

performance test specimen

requirements. The Commission is

considering each of these suggested

revisions and invites public comment

on the following:

a. A limited HHS survey of blind

performance test specimens supplied by

various vendors has indicated a wide

range of drug or metabolite

concentrations in spiked specimens.

Should the NRC require licensees to

assure that concentration ranges for

blind performance test specimens be

within a defined range (to be

determined in consultation with HHS)?

b. Should the NRC require that

providers of performance test specimens

be separate and independent (no

conflict of interest) from those

performing the specimen collection,

specimen testing, MRO, and auditing

functions?

8. The NRC has received requests

from several licensees and vendors to

permit the on-site use of noninstrumented, qualitative immunoassay

methods that involve the use of

inexpensive, disposable devices. As

discussed in more detail under the

proposed changes to Section 2.7 of

Appendix A, these screening techniques

have not been validated to achieve the

high levels of specificity and accuracy

that are needed in FFD programs. Of

concern to the Commission is that these

devices may produce an unacceptably

high number of false negative test

results and may be easily subverted. The

Commission invites public comment on

the advisability of creating guidelines,

quality assurance procedures, and

performance standards to govern use of

these devices. Alternatively, should the

Commission prohibit the use of these

devices until such time as HHS (or

another agency) has developed

guidelines, procedures, and standards.

Should there be a Conforming Products

List for these devices similar to that

published by the National Highway

Traffic Safety Administration (NHTSA)

for evidential breath measurement

devices? Who should administer such a

program?

Groups of Interrelated Revisions

Several of the proposed rule changes

should be considered as groups of

interrelated revisions that, if adopted,

will interact with each other and with

the current rule to accomplish

important FFD objectives. Foremost

among these are several revisions

intended to minimize subversion of the

testing process. Subversion has proven

to be a continuing problem that

threatens the effectiveness of workplace

testing programs across the country.

Although a number of techniques for

subverting the testing process exist,

flushing (diluting the specimen by

drinking copious amounts of water)

appears to be the most common. The

proposed rule is intended to reduce the

potential for successful subversion by

flushing include (1) a requirement that

licensees minimize the time between

notification of the person to report for

a random test and the collection of the

specimen and (2) a requirement to

determine the validity of specimens,

which would be done through testing

for specific gravity (SG) and may

include several other methods. Other

forms of subversion include the

adulteration of specimens and the

submission of surrogate specimens.

Reducing the time between notification

and testing will also counter these

subversion techniques. To further

reduce the potential for subversion, the

NRC proposes using a narrower

temperature range than set by the HHS

guidelines for determining an

acceptable specimen. This would make

it more difficult to submit surrogate

specimens and to use some dilution

techniques. The proposed rule also

would revise various sections to state

more clearly that any act or attempted

act of subversion is to be considered a

violation of FFD policy. These revisions

would provide an integrated response to

the problem of subversion.

The Commission also is proposing to

require that dilute and other

questionable specimens be tested at the

lowest level of detection (LOD) that the

laboratory is qualified to use. While this

revision would have an anti-subversion

effect, its primary purpose would be to

further protect those being tested.

Currently, when a testing laboratory

determines that a specimen is dilute or

otherwise of questionable quality, the

person tested is required to produce a

second specimen under the direct

observation of a collection site person.

Test results indicate, however, that a

great majority of dilute specimens result

from reasons other than drug use.

Requiring level-of-detection testing

would infringe less on the individual’s

privacy by minimizing the need to

produce a second specimen under direct

observation. It would protect those

being tested also by providing MROs

with additional useful information to

enable them to make accurate

determinations of whether a specimen

of questionable validity has actually

been adulterated or diluted.

The proposed revisions pertaining to

removal from unescorted access because

of FFD policy violation and subsequent

return to work constitute a second

important group of interrelated

revisions. One revision would clarify

the Commission’s original intent that

any violation of a licensee’s FFD policy

must result in immediate removal from

unescorted access status upon

determination of a violation. Before a

person is allowed to return to work, the

condition that led to removal would

have to be resolved through a medical

determination of fitness conducted by

appropriately qualified personnel and

the person would have to be tested

under a proposed return-to-duty testing

requirement. Another related revision

would clarify the Commission’s intent

that persons to whom unescorted access

is reinstated after a policy violation are

to be subject to follow-up testing for a

three-year period. These and other

proposed changes are intended to

provide a more complete set of

requirements relating to removals and

return to duty.

The NRC is also proposing a set of

revisions that would address situations

in which individuals subject to the

rule’s testing requirements are only

infrequently on site. Although most

licensees have appropriate provisions in

this area, several licensees have gone to

great expense in bringing off-site

workers to the collection facility for

testing immediately upon their being

chosen from the random testing pool.

Some off-site workers have been

required to drive 2–4 hours each way,

fly cross country, and/or stay overnight.

Some licensees use mobile collection

facilities or teams to travel to the

location of the person selected for

testing. One proposed revision would

make clear the NRC’s original intent that

people need not be immediately brought

to the site for testing in such situations.

Another related revision would

eliminate the requirement for a suitable

inquiry into a person’s employment

status when the person returns to a site

after having not been covered by an FFD

program for thirty days or less. This
Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules 21109

revision would also clarify the

requirements applicable to individuals

who come to the site only infrequently.

A fourth group of revisions relates to

testing for alcohol. Impairment caused

by alcohol misuse creates a safety risk

that is fundamentally similar to the risk

posed by the misuse of illegal drugs.

Some licensees, however, have imposed

lesser sanctions for alcohol violations,

an approach that is contrary to the

Commission’s intent. The NRC proposes

to rectify this situation by explicitly

requiring the same minimum sanctions

for abuse of alcohol as currently exist

for use of illegal drugs. Several

proposed revisions would contribute to

this objective. One revision would

explicitly define the FFD policy

violations involving alcohol. Likewise,

alcohol test results between 0.02 and

0.04 percent would be forwarded to the

Medical Review Officer (MRO) for back

calculation to determine whether the

person had an impermissibly high blood

alcohol content while on duty. The

requirements concerning conduct of

suitable inquiries would also be revised

to explicitly require that licensees

determine whether persons seeking

unescorted access status have ever used

alcohol in a manner that resulted in onduty impairment.

A fifth group of proposed revisions

would address current ambiguities

associated with the testing for the use of

amphetamines. The standard for

confirmatory testing for

methamphetamines would be

supplemented with the requirement that

specimens must also contain a specific

amount of amphetamine to be

confirmed as positive. Multiple

screening tests would be permitted to

reduce the amphetamine testing

problems caused by cross reactivity. A

requirement that specimens confirmed

positive for amphetamines must also be

tested for d and l isomers is another

related proposed revision. Another

proposed revision would allow an extra

two days for HHS-certified laboratories

to report to licensees test results having

suspected amphetamines. These

revisions would serve to clarify and

rationalize testing requirements for

amphetamines.

Use of Old Test Results

The NRC also cautions licensees that

test results obtained before January 3,

1990, should be considered with great

care. The results may be questionable

for the following reasons:

• The HHS laboratory certification

program was initiated in 1988 and by

the end of 1989 about 40 laboratories

were certified. Many of the laboratories

being used did not meet current

performance standards for accuracy and

reliability.

• In some cases, confirmation tests

may not have been conducted.

• In many cases, there was no review

by a technically qualified person, such

as a MRO, to determine if legitimate

uses of drugs (particularly

amphetamines and opiates) were

causing the results reported by the

laboratories.

The NRC staff has been informed of

several cases in which persons alleged

they had a record of a questionably

positive drug test 5 to 15 years ago, have

since worked in the nuclear industry

with a good work record and no positive

drug tests, and are now denied

employment. The Commission

recognizes that positive drug test results

obtained before the rule was

implemented may indicate persons who

have a significant past history of drug

abuse but, because of the factors noted

above, other available information

should also be considered.

Description of Proposed Changes by

Section

The following discussion describes

the changes to the current FFD rule that

are being proposed and the reasons for

the changes.

Section 26.2 Scope

The NRC proposes to amend this

section to include specified classes of

personnel who administer testing

programs. Although Section 2.3 of

Appendix A requires that licensees

carefully select and monitor persons

responsible for administering the testing

program based upon the highest

standards of honesty and integrity, some

licensees’ testing programs have not

included all persons originally intended

to be tested. This action is taken to

clarify the Commission’s original intent

because although these people normally

work outside the protected area, their

actions do have an ongoing effect on

safety and would have an impact on the

confidence of management and the

workforce in the integrity of the

program and the reliability of the

results. Persons who administer testing

programs are in a position to permit

substance abusers to remain undetected.

The persons who administer the tests

could inadvertently omit testing of an

employee as a result of impaired

behavior on the part of the test

administrator because of substance

abuse or intentionally because of

motives associated with substance

abuse, empathy with the abuser, etc.

Furthermore, the omission of test

administrators from testing and other

program requirements tends to

undermine the credibility of licensees’

FFD programs.

Several reported incidents have

confirmed the need to assure that FFD

program personnel meet the highest

standards of honesty, integrity,

reliability, and trustworthiness. For

example, one licensee added collection

personnel to the testing pool after

investigation of an allegation

determined that two specimen

collectors were substance abusers. In

another instance, a contracted MRO not

in the testing pool was reported to be an

alcoholic and an abuser of prescription

drugs.

The proposed revision to § 26.2(a)

would fulfill the NRC’s original

objective for this section and require all

licensees to extend the coverage of their

programs to the following three classes

of FFD personnel:

• Personnel who can link test results

with the person who was tested;

• Personnel making removal and

return-to-work recommendations or

decisions; and

• Personnel involved in the selection

and notification of employees for testing

and the collection of specimens.

Specimen collectors, the MRO, the

FFD program manager, Employee

Assistance Program (EAP) counselors,

and other selected administrative staff

would be examples of FFD program

personnel who would be included

within this clarification of the rule’s

scope. Testing of FFD personnel is

further discussed in conjunction with

Section 2.3 of Appendix A.

The NRC also proposes to amend

§ 26.2 to allow reduced scope programs

for facilities that are in the process of

being decommissioned. Because the

level of risk associated with these

facilities will decline during

decommissioning, the revision is

designed to provide the NRC with the

flexibility to tailor the FFD program to

site-specific factors as deemed

appropriate by the NRC to protect

public health and safety.

Finally, the NRC proposes to amend

§ 26.2 to provide that people covered by

a program regulated by another Federal

or state agency that meets the general

performance objectives of the FFD rule

need not be additionally covered by a

licensee’s FFD program. Duplicate

testing and training requirements

applicable to an appreciable number of

individuals working at nuclear facilities

have become an increasing problem as

the Department of Transportation’s drug

testing requirements and new alcohol

testing rule have been implemented.

Differences in specific program

requirements, such as the use of

different cut-off levels (but which are at
21110 Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules

least as stringent as the HHS

guidelines), would be unlikely to have

a significant effect on the licensee’s FFD

program in meeting the general

performance objectives. The licensee

would continue to be responsible for

behavioral observation, immediate

removal from duty of persons whose

fitness may be questionable, and forcause testing for a specific situation.

This revision would reduce the burden

on individuals covered by multiple

Federal and State programs with

requirements that duplicate the FFD

rule.

Section 26.3 Definition

The NRC proposes that this section be

modified to clarify definitions of some

terms, to make terms and definitions

more consistent with those used by

other Federal agencies (including the

Substance Abuse and Mental Health

Services Administration and the

Department of Transportation), to

provide new definitions to support

other sections of the rule, and to remove

three terms, ‘‘random test,’’ ‘‘follow-up

testing,’’ and ‘‘suitable inquiry,’’

because they are already fully defined in

the text of the rule. In addition, several

terms have been moved to this section

from Section 1.2 of Appendix A because

they first appear in the main body of the

rule.

For the most part, changes in this

section are intended to eliminate

differing interpretations and ambiguities

in current wording. The Commission

proposes three changes to the terms

used for definitions of drug test results.

The changes include modification to the

definition of ‘‘confirmed positive test’’

to reflect proposed changes to terms and

definitions, and the addition of the

terms ‘‘laboratory confirmed positive’’

and ‘‘unconfirmed positive test result.’’

‘‘Laboratory confirmed positive’’ would

refer to the positive outcome of a gas

chromatography/mass spectrometry

(GC/MS) test. These tests are reviewed

by the MRO to determine if they show

a violation of the FFD policy or if there

is a medical explanation for the positive

result. ‘‘Unconfirmed positive test

result’’ would refer to the result of a

screening test that is not negative. The

original wording of the rule refers to

these results in a number of ways, most

often as ‘‘presumptive positives.’’ The

term ‘‘presumptive positive’’ and other

terms used to refer to this result have

been replaced with ‘‘unconfirmed

positive test result’’ throughout the rule

to increase clarity and consistency. The

definition of ‘‘confirmatory test’’ would

be revised to reflect a proposed revision

made elsewhere in the rule relating to

blood tests for alcohol that could be

used in an appeal. The term ‘‘screening

test’’ would replace the former terms

‘‘initial or screening test’’ in the

interests of clarity.

The NRC proposes to add a definition

of ‘‘medical determination of fitness’’ to

support proposed changes to other

sections of the regulation. This term

would clarify the role of the MRO or

other licensed physician in determining

fitness for duty and provide a standard

regarding what constitutes this

determination. The focus of the medical

determination would be to determine if

a rule or policy violation has occurred

and to evaluate the potential for on-duty

impairment (e.g., of sensory, cognitive,

motor and communicative skills) that

would interfere with the safe

performance of the individual’s duties.

A new definition of ‘‘behavioral

observation’’ is proposed that would

clarify the role of supervisors in

monitoring the behavior of workers

under their oversight. It is the NRC’s

intent that all personnel having

unescorted access to the protected area

be subject to behavioral observation. To

accomplish this goal, supervisors are

expected to observe the behavior of all

personnel with whom they have routine

contact, not only those workers for

whom they have direct supervisory

responsibility. Licensees would, for

example, be responsible for ensuring

that contractor employees whose

supervisors may remain off site be

subject to behavioral oversight by

licensee supervisory personnel when

within the protected area. The

contractor employees would, however,

still be subject to behavioral observation

by their own supervisors when off site.

A definition for ‘‘supervisor’’ is

proposed to clarify that supervisors

include all personnel with supervisory

responsibilities over workers with

unescorted access, whether they are on

site or off site.

The NRC proposes to add the terms

‘‘abuse of legal drugs’’ and ‘‘substance

abuse’’ and definitions for these terms to

clarify the intent of the rule and to

support changes to management actions

and sanctions regarding alcohol and

other legal drugs and substance abuse.

The NRC proposes to add the term

‘‘subversion’’ and to define it in terms

of the intentional causing of a missing

or inaccurate drug or alcohol test result

at any stage of the testing program,

including the process of selection and

notification, specimen collection,

specimen analysis, testing, and

reporting of test results.

Finally, the NRC proposes that the

definition of ‘‘aliquot’’ be modified by

adding language designed to make it

clearer that the aliquot is a

representative sample of a specimen and

can be used for retesting.

Section 26.7 Communications

A new section, ‘‘Communications,’’

similar to existing sections in other 10

CFR Parts would be added to ensure

that communications with the NRC are

processed properly.

Section 26.8 Information Collection

Requirements: OMB Approval

The NRC proposes to delete § 26.8(c)

which presents an estimate of the total

time burden for this Part’s

recordkeeping requirements and solicits

licensee comments concerning the

accuracy of the estimate and ways by

which the burden can be reduced. This

information is not normally codified in

the regulations and is being deleted to

maintain consistency with other parts

throughout 10 CFR Chapter I. Burden

estimates and requests for public

comments on the burden estimates

continue to be published in the

preamble of Federal Register Notices for

NRC rulemaking in accordance with

Office of Management and Budget

(OMB) regulations.

Section 26.20 Written Policy and

Procedures

The NRC proposes several changes to

this section. One amendment would

make it clear that licensees’ overall

description of their policy on FFD must

be prepared in a summary form, which

most licensees have done, and made

readily available to employees covered

by the rule [§ 26.20(a)]. It has been noted

during inspections that a few licensees

had incorporated their FFD policy into

the several procedures that were not

readily available to employees. The

NRC’s intent remains that licensees

publish a statement notifying employees

of the policy as is required by the DrugFree Workplace Act of 1988.

Other amendments would clarify

§ 26.20 (a) and (d) to ensure that a

licensee’s FFD policy addresses

employees’ off-site involvement with

illegal drugs, the abuse of legal drugs,

the subversion of the testing process by

adulterating or substituting specimens,

the refusal to provide a specimen, and

use of prescription and over-the-counter

medications that may cause impairment.

This revision would make explicit the

need to address FFD concerns that have

emerged during the first five years of

program operation.

Another amendment would clarify the

requirements pertaining to licensees’

procedures to ensure that persons called

in to perform an unscheduled working

tour are fit to perform the task assigned

[§ 26.20(e)]. This section currently
Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules 21111

requires called-in employees to state

whether they have consumed alcohol

within the licensee’s pre-duty

abstinence period. The proposed

revision would make it clear that this

declaration of fitness includes fitness to

perform tasks assigned, not just alcohol

consumption. These revisions would

afford employees an added safeguard in

that they would have an opportunity to

express their own opinion as to whether

they believe themselves fit in view of

fatigue, illness, use of medication or

consumption of alcohol to perform

assigned tasks. This requirement would

also enable licensees to obtain the

information over the telephone to avoid

having to get that person safely home

after arriving onsite unfit to work, call

in another person, and avoid the

potential for civil lawsuits that could

arise from accidents while the called-in

person is in travel.

Another amendment would remove

the statement that the Commission may

review the licensee’s FFD policy and

procedures at any time [§ 26.20(f)]. This

provision is unnecessary because the

Commission may always inspect the

licensee’s program.

A new § 26.20(f) would add a

paragraph that would allow licensees to

credit unescorted access status granted

by other licensees. Such individuals

must be covered by the random testing

and behavioral observation programs of

either the original licensee employer or

that of the host licensee. This change

would facilitate the interchange of

personnel among licensees in, for

example, situations where a ‘‘peer

evaluator’’ from one licensee works with

a second licensee (e.g., inspections

conducted under the auspices of the

Institute of Nuclear Power Operations

(INPO)). It clarifies that there is no need

for a licensee to audit another licensee’s

program before granting unescorted

access to that licensee’s employee.

The NRC continues to believe that an

abstinence period of at least 5 hours

preceding any scheduled working tour

is appropriate and wishes to clarify the

implications of this abstention period

for employees. This requirement

continues to accommodate a reasonable

and moderate amount of off-duty

alcohol consumption outside the

abstention period. Employees do need

to be aware, however, that immoderate

alcohol consumption, even if it occurs

before the start of the abstinence period,

can later result in an FFD policy

violation. If, for example, an employee

were to consume a relatively large

volume of alcohol six hours before

starting work and, in the interim,

consume a heavy meal (the

consumption of food can significantly

slow the metabolism of alcohol), the

employee could be at risk of violating

FFD policy (i.e., could have a blood

alcohol content (BAC) of 0.04 percent or

higher when reporting for work).

Therefore, it is incumbent upon

employees to exercise restraint in their

alcohol consumption even outside of

the 5-hour abstention period. Although

moderate off-duty drinking is not

prohibited by FFD policy, employees

should understand heavy alcohol

consumption can be an FFD concern

even though it occurs before the

abstinence period. The NRC is aware

that some past alcohol-related violations

of licensees’ FFD policies have resulted

from employees’ lack of understanding

of these issues. Communication of these

matters to employees is particularly

important because the proposed rule

would make management sanctions

mandatory for alcohol-related FFD

policy violations.

Section 26.21 Policy Communications

and Awareness Training

The NRC proposes to decrease the

frequency of FFD policy and awareness

refresher training from every 12 to every

24 months. However, the Commission

expects that FFD program changes, such

as would be mandated by final

rulemaking, would be communicated to

all affected workers before the changes

are implemented. The material

presented in this training is relatively

straightforward and is not expected to

change significantly over time.

Refresher training on a nominal 24-

month frequency would be sufficient to

keep personnel covered by the rule

aware of FFD program policy and

procedures. Another proposed

amendment to this section would allow

licensees to accept the generic portions

of training of individuals who have been

subject to a Part 26 program at another

site and have received initial or

refresher training within the past 24

months; site-specific training would

continue to be required before

unescorted access may be granted.

Policy communications and awareness

training covers a number of common

areas that are consistent across licensee

programs. Because there are some

differences among licensees, new

personnel should be trained in those

aspects of licensee programs that are

particular to the site.

Section 26.22 Training of Supervisors

and Escorts

The NRC proposes to amend the

provision pertaining to the initial and

refresher FFD training of supervisors

and escorts. One amendment would

clarify the NRC’s intent that, except in

the case of people receiving their initial

supervisorial assignment, all

supervisors of licensee employees and

contractor personnel and all escorts

must fully complete their initial FFD

supervisory training before assignment

to duties within the scope of Part 26.

Supervisors of licensee employees

receiving their initial assignment would

be required to complete training as soon

as feasible but would continue to have

up to three months to complete initial

training. Supervisors of contractor

personnel receiving their initial

supervisorial assignment would have

only ten days to complete initial

training. Given the higher rate of

positive tests among contractor

personnel, it is particularly important to

ensure that contractor supervisors

complete their training either before or

very soon after they assume their duties.

Although the NRC considered amending

the rule to clarify requirements

concerning situations in which

contractor, and possibly some licensee,

supervisors do not have unescorted

access privileges themselves but

supervise people who do have such

privileges, it believes the following

guidance should suffice. The NRC

expects that those supervisors who do

not come on site would be trained in

drug recognition, behavioral

observation, and procedures for

initiating corrective action. The NRC

also expects that, while on site, these

workers are observed by someone

trained in these matters.

The NRC is concerned that some

licensees may have appointed people as

‘‘acting’’ supervisors for periods of less

than three months and have given these

people none of the programmatic

training required by this section. The

NRC believes that even ‘‘acting’’

supervisors must be trained in the five

topics appearing in § 26.22(a) as soon as

feasible.

The NRC is also proposing to allow a

written examination that demonstrates

an adequate knowledge of pertinent FFD

issues and material to be used in lieu of

refresher training for supervisors and

escorts in two out of every three years.

Allowing the use of a written exam

would increase flexibility without

compromising the integrity of FFD

programs and may decrease

administrative expenses. The NRC has

declined to change the nominal 12-

month frequency associated with this

refresher training for supervisors and

escorts as it proposes to do for the

policy communications and awareness

training required by § 26.21(b).

Supervisors and escorts must, for

example, be able to recognize drug use

or degradation of performance of the
21112 Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules

people working around them. Having

training, or a written examination in

lieu of training, at an interval of more

than 12 months may not be sufficient to

ensure that supervisors and escorts

would remain diligent and effective in

performing these functions.

Another proposed amendment would

allow licensees to accept the training of

people who have been subject to a Part

26 program at another site and have had

initial or refresher training (or testing in

lieu of refresher training) within 12

months before assignment to

supervisory duties. This proposed

revision would facilitate the movement

of supervisory personnel among

licensees and decrease licensee costs for

training individuals in a number of

common areas that are consistent across

licensee programs. As noted previously,

because there are some differences

among licensees, new employees should

be trained in those aspects of the

licensee’s program that are site specific.

As noted by the Commission’s

regulatory review group, behavioral

observation training as described in

§ 26.22(a) should not focus solely on

substance abuse. Instead, it should also

provide managers and supervisors

training in appropriate actions to take

(e.g., referral to EAP) when individuals

have FFD problems other than

substance abuse that affect them (e.g.,

stress, fatigue).

Section 26.23 Contractors and

Vendors

This section currently requires that

personnel who have been denied access

or removed from activities within the

scope of Part 26 for violations of an FFD

policy will not be assigned to activities

within the scope of Part 26 without the

knowledge and consent of the licensee.

During the first five years of FFD

program operations instances occurred

in which personnel with a history of

substance abuse known to the contractor

employer were sent on site without the

licensee being informed of such history.

Therefore, this section is revised to

make clear that persons with a known

(to the contractor or vendor) history of

substance abuse must not receive these

assignments without the knowledge and

consent of the licensee.

The NRC understands that some

contractors have requested escorted

access for individuals with a drug

history in order to avoid informing the

licensee. The Commission desires

comments as to whether the rule should

be revised so that this practice is no

longer permitted.

Section 26.24 Chemical Testing

The NRC proposes to revise the

descriptions of the four types of testing

that are currently required. The

proposed changes are intended to rectify

inconsistent interpretations of testing

requirements that have appeared across

the industry during the five years of

FFD program operations. In

§ 26.24(a)(1), chemical testing before

granting unescorted access would be

referred to as ‘‘preaccess testing.’’ It

continues to be the NRC’s intention that

any test, whether before or after the

beginning of a person’s term of

employment with the licensee, that is

performed with the intent that it may be

a test as required by § 26.24(a)(1) must

meet the standards set forth in Part 26

and be reported to the NRC as a

preaccess test. One proposed

amendment to this paragraph designed

to reduce unnecessarily redundant

testing of applicants for access

privileges, would allow licensees to

consider any drug and alcohol test

meeting Part 26 standards and

performed within 60 days before the

granting of unescorted access to serve as

a preaccess test. A test performed by

another licensee or under a testing

program required by the U.S.

Department of Transportation are

examples of tests that would qualify as

preaccess tests under this proposed

revision. In such circumstances, the

NRC would expect that licensees would

use a dependable means of confirming

that the person seeking access had

actually been tested. This could be

accomplished by the electronic

exchange of pertinent information

among licensees using a computerized

data base that the industry is currently

considering for implementation.

As another clarification of the NRC’s

original intent, as described in item

number 4.5 of NUREG–1385, ‘‘FFD in

the Nuclear Power Industry: Responses

to Implementation Questions,’’

§ 26.24(a)(1) would be amended to

explicitly prohibit the granting of

unescorted access until the person’s

negative preaccess test result has been

obtained. However, another change

would allow some relief from this

requirement. Unescorted access could

be granted before receipt of a negative

test result if the person seeking access

has no history indicating the use of

illegal drugs or the abuse of legal drugs

and has either had a negative result on

a test meeting Part 26 standards

performed within six months before the

granting of unescorted access or been

covered by a program meeting Part 26

standards for two consecutive weeks

during that six-month period. This relief

from the requirement to obtain a

negative test result before the granting of

access is based upon industry

experience of the demonstrated

reliability of workers who have been

covered by a rigorous program in the

past. In these circumstances, the NRC

expects that licensees would confirm

the occurrence of such tests or such

coverage. These proposed revisions are

intended to reiterate the importance

attached to establishing an individuals’

fitness status before unescorted access is

granted. At the same time, these

revisions would allow some efficiencies

borne out by industry experience in the

granting of access without

compromising public health and safety.

Some additional relief would be

provided where the individual is

transferring from another licensee. In

this case, if the individual has been

covered by an FFD program for 30 of the

previous 60 days, no specimen need be

collected and tested.

Other proposed changes to this

section (§ 26.24(a)(2)) would more

clearly describe the full meaning of the

currently required attributes of random

testing. Some licensees who randomly

tested only during weekday day shifts

provided predictable gaps in testing.

People working during evenings and on

weekends knew they would not be

tested. Workers who were randomly

selected for testing, but did not happen

to be on site at the time scheduled for

specimen collection because they

normally worked off site or worked a

night or weekend shift, were deleted

from the list of people to be tested that

day and other workers who were

present substituted in their place. Thus,

not all workers had an equal chance of

being tested. All testing personnel and

employees must be made aware that

tests are truly random and

unpredictable, and therefore that

unannounced tests may occur during

any day or night duty hours. Predictable

patterns of random testing are

prohibited by the rule. The proposed

rule changes would create no new

random testing requirements, but would

instead clarify currently existing

requirements that random testing be

unpredictable and conducted at various

times during the day. As discussed in

item number 4.6 of NUREG–1385,

which points out that HHS’s ‘‘Medical

Review Officer Manual’’ suggests that

random sampling procedures should

permit no ‘‘safe periods’’ for any

employee: ‘‘Each work day should

present each employee with a new

opportunity of having to produce a

sample. * * *’’

A provision would be added to clarify

that reasonable efforts must be made to
Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules 21113

test persons selected for random testing.

For persons off site and within a

reasonable traveling time and distance,

the NRC expects collection of specimens

be completed as promptly as

notification and travel can be

accomplished. For other persons

selected for random testing, the NRC

expects that upon their return to the site

they be promptly notified and tested

under the provisions of § 26.24(a)(2) and

that the test would be recorded as a

random test.

A proposed amendment would

provide flexibility to conduct for-cause

tests (§ 26.24(a)(3)) no more than 2

hours for the alcohol part of the test and

8 hours for the drug part of the test

following an indicated need for testing.

This change is intended to

accommodate situations where no

collection personnel are on site and

need to be called in or the individual

needs to be transported to another

location for testing. While it is in the

best interests of both the licensee and

the worker in this situation to collect

the specimens as soon as possible, as

currently required, more flexibility is

appropriate. A shorter time is specified

for alcohol because of the more rapid

metabolism of this substance.

Other additions to this section would

be clarification of the conditions that

initiate a for-cause test and clarification

that an MRO or other licensed medical

person must determine the fitness for

duty of an individual tested for cause

before that worker may return to duty.

Although the NRC considered amending

the rule to clarify requirements

concerning situations in which a worker

may be potentially impaired from

causes that would not be detectable by

drug and alcohol testing, it believes the

following guidance should suffice.

Although impairment caused by factors

other than substance abuse is usually

not a violation of the FFD rule by the

worker, it is the responsibility of the

licensee to assure that no impairment,

regardless of cause, threatens public

safety.

The NRC has received, but declined to

adopt, recommendations that this

section be revised to authorize licensees

to administer an ‘‘alcohol-only’’ test in

certain situations. Under this

recommendation, only a breath test

would be required when conditions that

directly indicate alcohol use, such as

alcohol on the breath, create a

reasonable suspicion that the person

may have misused alcohol in violation

of the licensee’s fitness-for-duty policy.

The NRC believes that allowing an

alcohol-only test in these circumstances

would be inappropriate. It is preferable

to perform both an alcohol test and a

drug test, whether the alcohol test is

positive or negative, to fully investigate

the individual’s fitness for duty.

However, if the alcohol test is negative

and the individual is determined fit by

a designated licensee representative

qualified to make the determination, the

individual could be returned to duty

pending laboratory testing of the urine

specimen and receipt of urinalysis

results. The Commission believes that

this provides an appropriate balance

between assurance of a thorough inquiry

and determination of fitness and

reduction of the impacts caused by time

away from the work station.

The requirements pertaining to

follow-up testing (§ 26.24(a)(4)) would

be clarified by incorporating the

provisions of § 26.27 (b) (4) to make

explicit that all people to whom

unescorted access is reinstated under

§ 26.27(b) must be subject to

unannounced and unpredictable testing

for at least three years following

reinstatement. The duration of followup

testing is supported by research which

indicates that chronic abusers of alcohol

and other drugs usually need several

years to recover from their habits. Under

these proposed amendments, licensees

would be required to adopt a program

that is tailored to the individual’s

medical history and that meets these

minimum requirements. These

amendments are intended to clarify the

current conditions under which

licensees can reinstate unescorted

access following a first or second

violation of an FFD policy. A proposed

requirement that the testing be

unpredictable is added to conform the

followup testing to the existing

requirements for random testing.

The NRC proposes to add a fifth

type of required chemical testing referred to as ‘‘return-to-duty’’ testing

(§ 26.24(a)(5)). In its current form, the

rule does not clearly state the

Commission’s intent that licensees

should test personnel having unescorted

access when they return to work after

extended absences. The NRC staff is

aware that most, but not all, licensees

are already testing people when they

return to their sites after extended

absences. The proposed new

§ 26.24(a)(5) would require return-toduty testing when workers seek to

regain unescorted access to protected

areas in two types of circumstances.

First, workers seeking to regain

unescorted access after having been

denied access under the provisions of

§ 26.27(b) would be tested and a

negative result obtained before access is

restored. Second, a worker who seeks to

regain access at a particular licensee’s

plant after an absence from the

possibility of being tested under that

licensee’s FFD program for more than 60

days would have to be tested under this

requirement. Provisions are made in the

rule to lessen the impact. This proposed

revision is also intended to clarify

expectations regarding individuals

selected for random testing who are

away from the site and not available for

testing. The NRC staff understands that

some licensees are currently calling

people in for random tests from long

distances (e.g., a 2- to 4-hour drive each

way, cross-country flights, overnight

stays). Some licensees use mobile

collection facilities or teams to travel to

the persons selected for testing. The

NRC staff is also aware that many

licensees are routinely testing people

such as utility headquarters staff,

contractors, and consultants who come

to the site only infrequently but may

have access status. The new return-toduty testing requirements and the

revisions to the pre-access and random

testing requirements (§ 26.24(a) (1) and

(2)) are intended to provide licensees

the explicit flexibility to adjust their

testing programs to eliminate

unnecessarily ‘‘heroic efforts’’ to test.

The 60-day period was chosen in

order to be consistent with the current

preaccess processing standards in

NUMARC 91–03, ‘‘Nuclear Power Plant

Personnel Access Authorization Data

Exchange Guidelines,’’ dated October

1992. The industry guidelines provide

that to be issued a badge in a situation

where an individual has an existing

access authorization, the individual

must either be currently covered by an

FFD program including random testing,

or have satisfactorily completed

preaccess drug and alcohol testing

within 60 days before badging, and be

subject to a behavioral observation

program and an FFD program. The

industry guidelines also provide that the

individual’s activities should be

checked if a licensee or contractor/

vendor employee had been away from a

licensee, or approved contractor/vendor,

behavioral observation program for

more than 30 consecutive days. The

industry guidelines also provide that

suitable inquiry should be updated if

reinstatement of access is requested for

an individual who has been away from

an FFD program for a period of 30 days

or more.

For workers who have been absent

from the possibility of being tested

under the licensee’s program for more

than 60 days, any drug or alcohol test

meeting Part 26 standards and

performed within 60 days before the

granting of unescorted access could

serve as the return-to-duty test. The

returning worker would have to obtain
21114 Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules

a negative test result before returning to

work unless he or she has no history

indicating the use of illegal drugs or the

misuse or abuse of legal drugs and has

either had a negative result on a test

meeting Part 26 standards performed

within six months before the

reinstatement of unescorted access or

been covered by a program meeting Part

26 standards for two consecutive weeks

during that six-month period. As was

adopted for preaccess testing, tests

performed by another licensee or under

a testing program required by the U.S.

Department of Transportation are

examples of tests that would qualify as

return-to-duty tests under this proposed

revision. In such circumstances, the

NRC would expect that licensees would

use a dependable means of confirming

that the person seeking access had

actually been tested or been covered by

another program. This could be

accomplished, for example, by the

electronic exchange of pertinent

information among licensees using a

computerized data base that the

industry is currently considering.

Various proposed editorial changes to

§ 26.24(d) would leave its requirements

essentially unchanged from the

amendment to this paragraph published

by the NRC on August 26, 1991 (56 FR

41922).

The NRC is proposing a new

paragraph (§ 26.24(e)) that would

require that licensees keep to a

minimum the time between notifying

individuals to be tested and the actual

collection of specimens. This

requirement is intended to eliminate a

significant vulnerability (time) in the

testing process. Time is very important

to persons attempting to avoid

detection. Time enables them to flush

themselves, obtain surrogate specimens,

or obtain materials to dilute or

adulterate their specimens. For

example, an investigation was

conducted to determine why two

adjacent sites, drawing their workforce

from the same geographic area, had

significantly different positive rates for

random tests. It was determined that

different time intervals between

notification and collection were the

cause of the discrepancy. The licensee

with the low rate had a 2-hour

notification policy not vigorously

enforced; the licensee with the higher

rate had a 15-minute notification policy

which it aggressively enforced. A DOT

study showed an increase in the

positive rate when there was little or no

prior warning of specimen collection.

Whereas ‘‘normal’’ random testing of

motor carrier personnel was positive at

a 2.5% rate, roadside stops produced at

a 4.8% positive rate. In response to that

experience, DOT revised its rule to

require the person, upon notification, to

immediately proceed to be tested. NRC

inspections and surveys indicate that

some licensees keep workers on the job

and test them only at the end of a shift

even though they have been notified

that they are to be tested hours before.

In other cases, licensees permit delaying

tactics that result in lengthy periods

between notification and testing. In both

of these cases, alcohol can be

metabolized below detectable levels and

the person can flush himself or herself,

to some degree, of drugs. Some licensees

release workers for tests in a manner

that allows them ample opportunity to

obtain materials that might subvert the

test results (e.g., adulterants or surrogate

samples kept in a locker or vehicle). The

NRC understands that operational

necessity may prevent the tested person

from reporting immediately and that

being escorted between notification and

test may be an unreasonable burden.

However, several licensees have

reduced the notification time by using

the supervisor to coordinate the

worker’s availability for testing and

withhold notification until the

individual must proceed to the

collection site. Licensees report that this

approach does not cause any burden or

inconvenience; it is merely a different

way of doing things. One licensee

reported that it escorted persons

selected for random testing without

giving them prior notice, which

produced a low number of questionable

specimens (NUREG/CR–5758, ‘‘Fitness

for Duty in the Nuclear Power Industry:

Annual Summary of Program

Performance Reports,’’ CY 1994,

Volume 5, page C–5). Therefore, the

Commission expects that licensees will

assure that opportunities for subverting

the test are eliminated as much as is

practicable.

Section 26.24(e) (paragraph (f) in the

proposed rule) currently requires that

MROs’ review of test results be

completed and licensee management

notified of those results within 10 days

of the initial positive screening test. The

intent of this requirement is to ensure

that results are obtained within a

reasonable time after specimen

collection. Industry experience has

indicated in some cases that the current

requirement is impractical. In order to

make this requirement more effective

across the industry, the NRC is

proposing to require that MROs’ review

of laboratory test results be completed

and licensee management notified ‘‘as

soon as practicable’’ after specimen

collection and no more than 14 days

after the collection of a specimen.

Because many licensees conduct on-site

screening tests, the ‘‘collection of a

specimen’’ standard would establish a

more consistent and controllable time

line than ‘‘initial screening test.’’ The

licensees conducting initial screening

tests on site would have the same

amount of time to review the HHScertified laboratories’ reports as do those

licensees not conducting onsite testing.

Experience has shown that the majority

of certified laboratories take only 1 to 3

days from receipt of a specimen to

screen and confirm tests; isolated

exceptions are usually caused by testing

for 6-acetylmorphine (6–AM), formerly

referred to as 6-monoacetylmorphine

(6–MAM), and occasionally by unusual

technical problems. The Commission

believes that most test results should be

known to an MRO within 5 to 7 days

from specimen shipment to the

laboratory. The Commission has no

great concern where there is a legitimate

technical basis for a short, reasonable

delay by the laboratory, for example,

where a specialized low-volume test,

such as 6–AM, is done twice a week

rather than every day. This revision

would require, therefore, that MROs

must advise licensee management of

available test results and of the progress

of the review if the review has not been

completed within 14 days of the

specimen collection. While slightly

relaxing the test result reporting

requirements, the NRC would still

expect MRO reviews to be completed as

soon as practicable, and, in accordance

with a proposed clarification of Section

2.9(c) of Appendix A, that the MRO

notify management immediately after

the determination of a positive test

result or other violation of FFD policy.

The NRC also proposes to clarify

§ 26.24(f) to require that the MRO must

report all violations of the licensee’s

FFD program to management in writing

and in such a manner that

confidentiality is ensured. This

requirement is also proposed as new

paragraph (i) in Section 2.9 of Appendix

A, which addresses reporting

requirements and the review of test

results. This provision is simply a

clarification of existing practice and an

adoption of a change made to the HHS

guidelines in June 1994, and would not

place a significant burden on licensees

since it would require that only FFD

program violations, rather than all test

results, be reported in writing to

management. Requiring that all

determinations of FFD program

violations be submitted in writing will

assist in preventing reporting errors.

Furthermore, although it is currently

common practice to submit such
Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules 21115

information in a manner that ensures

confidentiality, the NRC believes that

due to the sensitive nature of the

information this provision should be

explicitly required, as HHS does in its

guidelines.

The NRC proposes to modify

§ 26.24(g) with several editorial changes

to clarify requirements for performing

screening, confirmatory, and blind

performance tests at HHS-certified

laboratories. These changes serve to

clarify and explicitly state the currently

existing practice by licensees. In

addition, this paragraph and § 26.24(d)

would require licensees to ensure that

all collected specimens are tested and

that laboratories report results for all

specimen tests performed. This

provision serves to clarify existing

requirements, would be a companion to

the change to § 26.24(f), and would be

an adaptation of a change made to the

HHS guidelines in June 1994, in which

HHS required written reports on all

specimens, both positive and negative,

to ensure that all specimens had been

tested and all results reviewed by the

MRO.

The NRC is proposing to require that

a confirmatory test for alcohol be

performed if the screening test indicates

a blood alcohol concentration of 0.02

percent or greater instead of 0.04

percent as currently required

(§ 26.24(h)). In cases where the

confirmatory test indicates a blood

alcohol concentration between 0.02

percent and 0.04 percent, the result

would have to be forwarded to the MRO

for review and, if appropriate, back

calculation (see new Section 2.9(h) of

Appendix A). The purpose of this

procedure would be to determine

whether the tested person had a BAC of

0.04 percent or greater, indicating a

violation of the FFD rule, at any time

during the work shift.

Section 26.24(h) currently provides

for a blood test to be administered if the

tested person demands ‘‘further

confirmation’’ of a positive confirmatory

test for alcohol. The NRC is proposing

to revise the regulatory language to

better reflect the purpose of blood tests

in that they would be used for providing

additional information that could be

considered during an appeal pursuant to

§ 26.28. Furthermore, licensees would

be required to ensure that the blood

specimen is drawn promptly after the

confirmatory breath analysis. The result

of the gas chromatography analysis of

the blood specimen need not necessarily

be measured against the alcohol cut-off

level. Instead, the MRO should

determine in these cases whether it is

appropriate to extrapolate back in time

to estimate the highest BAC that the

worker had while on duty. In a related

matter, the NRC desires data on the

number of times blood specimens have

been drawn and any instance where the

BAC results were overturned.

Approaches licensees have taken to

maintain this capability and the

associated costs would be useful for

evaluation of possible future changes in

this requirement.

In another revision to this section, the

NRC is proposing a new paragraph

(§ 26.24(i)) to address cases where an

individual has a medical condition that

makes collection of breath, blood, or

urine specimens difficult or hazardous.

The MRO, in consultation with the

worker’s treating or private physician,

would be authorized to determine a

method of specimen collection provided

the methods chosen can achieve

comparable results. The Commission

anticipates that these occasions, which

would include, for example, postaccident testing of an injured

individual, would be extremely rare.

In connection with the blood tests

which may be performed under § 26.24

(h) and (i), the NRC notes that the

Occupational Safety and Health

Administration (OSHA) has determined

that some employees face a significant

health risk as the result of occupational

exposure to blood and other potentially

infectious materials because the

materials may contain certain

bloodborne pathogens. OSHA published

a final rule in the Federal Register on

December 6, 1991 (56 FR 64004), that

establishes requirements applicable to

all occupational exposure to blood or

other potentially infectious materials.

This coverage appears to include

personnel involved in the collection and

handling of blood specimens collected

pursuant to the NRC FFD rule. The

OSHA rule requires employers that have

one or more employees with this

occupational exposure to take several

measures to minimize the exposure.

These measures include determining

employees’ potential exposure,

establishing a written Exposure Control

Plan designed to eliminate or minimize

employee exposure, and taking various

precautions to prevent contact with

blood in the course of work. The NRC

anticipates that licensees will evaluate

their responsibilities under this OSHA

rule.

Section 26.25 Employee Assistance

Programs (EAP)

The NRC proposes to revise this

section by replacing the permissive

‘‘should’’ with the mandatory ‘‘must’’ to

clarify its original intent that licensees

design their employee assistance

programs to achieve early intervention

and must provide for confidential

assistance. While actually achieving

early intervention in all situations

where employees’ problems could

adversely affect on-the-job performance

may not be possible, it is reasonable to

expect that all licensees’ EAPs be

designed to achieve this goal and not

include obvious impediments to early

intervention. This would assure that self

referrals are kept confidential and do

not result in punitive action. The NRC

wishes to emphasize that Employee

Assistance Program staff shall inform

licensee management when a person

constitutes a hazard to himself or herself

or others and that self-referral does not

influence in any way the determination

of an FFD violation.

Section 26.27 Management Actions

and Sanctions To Be Imposed

The NRC proposes changes

throughout this section to require the

same sanctions for alcohol violations as

currently exist for use of illegal drugs.

Explicit sanctions were not contained in

the original rule because the NRC

wished to study the matter further. As

a result of further study, the NRC

concludes that impairment caused by

alcohol abuse creates a safety risk that

is fundamentally similar to the risk

posed by the use of illegal drugs. Both

types of abuse involve violation of

explicit licensee policies, are

unacceptable in the nuclear power

industry, and should strongly be

discouraged. Currently, licensees vary

widely in their responses to alcohol

abuse with sanctions ranging from a

three-day suspension to termination.

The FFD rule’s lack of explicit

minimum sanctions concerning alcohol

has created problems for many licensees

in negotiating and defending sanction

decisions. Creating minimum sanctions

for alcohol violations that are equal to

those of illegal drugs will assist

licensees in dealing with these

situations while sending a strong

message to workers about the risks

involved in abusing alcohol. As

discussed under the proposed changes

to § 26.20, it is important for licensees

to ensure that their employees

understand the several factors related to

alcohol consumption that could result

in a violation of the licensee’s FFD

policy. Section 26.27(a) would be revised to

clarify certain aspects of the

requirements for the written statement

obtained from persons seeking

unescorted access and for the conduct of

suitable inquiries. In both cases, the

revisions would require licensees to

determine whether the person has a

history of substance abuse or has

previously violated a licensee FFD
21116 Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules

policy. These changes are being

proposed with the intention of requiring

the gathering of more complete

information on the backgrounds of

applicants for unescorted access,

particularly as to potential problems

with the abuse of alcohol. In addition,

the history, except for removal from

activities within the scope of this part

due to actions taken as the result of an

FFD policy, would be limited to the last

5 years. It should also be noted that the

proposed revisions are intended to

ensure consistency between the suitable

inquiry aspects of both the access

authorization rule and the FFD rule and

that one suitable inquiry for each

worker should be sufficient to fulfill the

requirements of the two rules. As in the

Access Authorization program, ‘‘best

efforts’’ requirements of § 26.27(a)(3) are

accomplished through contacts with

previous employers. In addition, fitness

history need not be obtained for those

covered by other programs or absent for

30 days or less.

The NRC has received

recommendations that a standard form

be available for all licensees’ use in

performing suitable inquiries into

individuals’ backgrounds as required by

this section. The NRC will defer to

licensees should they wish to develop

and use this type of form.

There have been a few reports of

instances where a contractor or vendor

employee with concurrent unescorted

access to several power reactor sites had

tested positive and that information was

not shared with the other licensees.

Although the individual was denied

access by the testing licensee, the

unescorted access status was continued

by the other licensees. The NRC

considered requiring licensees to assure

that such notifications are made or to

make periodic checks with other

licensees and contractor employers but

believes that the licensees’ procedures

to implement the access authorization

rule (10 CFR 73.56) should facilitate the

sharing of the information.

Section 26.27(b)(1) would be revised

to clarify several points. Applicants

would be added to the types of people

to be denied unescorted access if their

fitness is questionable. Violations of

FFD policy, such as refusals to test or

subversion of the testing process, is

added as a basis for denial. The

successful resolution of the impairing or

questionable condition has been added

as a condition to assignment of duties,

and a more systematic review of the

fitness of all personnel being returned to

duty whose fitness had been deemed

questionable would be required. This

action is being taken because there have

been several instances in which

licensees did not remove or delayed

removal of workers whose fitness was

questionable and ‘‘automatically’’

returned workers to duty without a test

or adequate determination of fitness.

Companion changes are proposed for

§ 26.3, concerning medical

determination of fitness, and § 26.24(a),

regarding for-cause and return-to-duty

testing.

The NRC proposes various

amendments to § 26.27(b) (2) and (3)

[formerly one paragraph (2)]. The first

amendment would more clearly specify

that confirmed positive drug and

alcohol testing determinations are to be

considered violations of FFD policy.

Another amendment would clarify that

people who are suspended because of

policy violation are still to be covered

by the licensee’s FFD program with

respect to behavioral observation,

chemical testing, and sanctions for

violations and that a positive test result

during the assessment or treatment

period would constitute a second

positive test. In a related matter, the

NRC expects that, in those rare cases

when an individual is randomly tested

before the results of a previous test are

known to the individual and both

results are positive, the licensee will

consider whether the second test result

is likely to be the result of the use

indicated by the first test and, if not,

declare the second test to be a second

positive and take appropriate action. As

amended, this paragraph would also

require that a person who is reinstated

following a policy violation must

successfully complete a return-to-duty

test and be subject to subsequent followup testing.

Section 26.27 (b) (4) and (5) (formerly

paragraphs (3) and (4)) would be revised

to fully recognize the abuse of alcohol

as an FFD violation. The NRC also

proposes to revise paragraph (b)(5) to

more directly express its intention that

a person must be determined to be fit to

safely and competently perform

activities under Part 26 by an

appropriate licensee manager and the

MRO or other qualified physician before

being returned to those activities. Like

other proposed amendments to this

section, these amendments would be

intended to elevate the importance

given to licensee decisions regarding

unescorted access reinstatement

following FFD policy violations.

Section 26.27(c) would be clarified so

that the exact act that violated the FFD

policy is recorded and provided in

response to an inquiry. Subversion of

the testing process would be added to

the examples of violations that must be

recorded and provided in response to a

suitable inquiry. Each of these examples

of employee activity would be a

violation of the licensee’s FFD policy. A

new provision would require that any

attempt to subvert the testing process

must result in denial of unescorted

access for a minimum of three years

which would be consistent with the

sanction required by § 26.27(b)(3) for a

second violation of a licensee’s FFD

policy. This sanction was chosen

because the NRC wishes to convey the

seriousness of such acts. Lastly,

paragraph (c) would be revised to allow

licensees to dispose of records five years

following denial of any access

authorization resulting from the activity.

These revisions would establish a basis

for consistent minimum treatment of

these violations across all licensee

programs for employee activities that

have resulted in varying licensee

response during the first five years of

FFD program operation.

The NRC also proposes to revise

paragraph (d) of § 26.27 to direct

licensees to treat NRC contractors

similarly to NRC employees if a licensee

believes an NRC contractor to be under

the influence of any substance or

otherwise unfit for duty.

The NRC is aware that the

requirements of the American with

Disabilities Act of 1990 (ADA) may have

implications for licensees’ compliance

with the requirements of § 26.27. The

employment provisions of the ADA,

which became effective on July 26,

1992, require employers with 25 or

more employees to protect disabled

persons from discrimination in the

workplace. People who have previously

been addicted to drugs or alcohol but

who have been successfully

rehabilitated, or can demonstrate a

successful period of abstention or

negative test results, are among those

that the ADA protects. It is the NRC’s

understanding that a person who has

casually used drugs in the past but was

not addicted to those drugs cannot

claim the ADA’s protection. The Act

specifically excludes from its protection

employees or applicants who are

current users of illegal drugs. The Act

also specifies that covered entities may

require employees to comply with the

FFD regulations of the NRC to the extent

such employees are covered by these

regulations (Sec. 104(c)(5)(B), Pub. L.

101–336, 42 U.S.C. 12114; see also 29

CFR 1630.16(b)).

The Equal Employment Opportunity

Commission has published the

Americans With Disabilities Act

Technical Assistance Manual which

somewhat clarifies the meaning of

‘‘current use’’ of illegal drugs.

According to the Manual, ‘‘current use’’

is drug use that has occurred recently
Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules 21117

enough to justify an employer’s

reasonable belief that involvement with

drugs is an on-going problem. For

purposes of taking an employment

action, current drug use is to be

determined on a case-by-case basis and

is not limited to the day of use or recent

days or weeks. Clearly, when

determining whether a particular person

is a current user of drugs, and therefore

not eligible for ADA coverage, the

required amount of time that must have

elapsed since a person’s last use of

drugs must depend to a large extent on

the nature of the particular employment

context in which an employment action

is being considered. This is confirmed

by the Manual when it states that an

employer may take an employment

action against an employee with a

history of illegal drug use if it can

demonstrate that the individual poses a

direct threat to health or safety because

of the high probability that he or she

would return to illegal drug use.

The NRC’s policy, as reflected in 10

CFR Part 26, is that until a person can

show that he or she has abstained from

substance abuse for at least three years,

there is a continuing probability of

resumption of substance abuse that is

too high, given the exceptional safety

concerns of the nuclear power industry.

This has been supported by medical

evidence and clinical experience. Given

the heightened safety concerns of the

nuclear power industry, it is the NRC’s

view that a person is a current user and

not a disabled person under the ADA

because of drug or alcohol abuse until

that person has demonstrated

abstinence from substance abuse for a

minimum of three years after a positive

test. Even when considered disabled

because of drug or alcohol abuse, a

person covered by a program pursuant

to 10 CFR Part 26 is by terms of the

Americans With Disabilities Act still

subject to the NRC’s fitness-for-duty

regulations.

Section 26.28 Appeals

The NRC is proposing amendments to

the right to appeal granted by § 26.28.

This section currently requires that

people subject to the rule have an

opportunity to appeal positive drug and

alcohol test results. In keeping with

revisions to several other sections that

would be intended to counter testing

subversion, an amendment would

extend this right to appeal to all

determinations of FFD violations.

The NRC proposes to clarify that the

right to appeal includes applicants for

unescorted access. The NRC

understands that some licensees did not

provide an appeals process to persons

who tested positive on pre-access tests.

The factors that could produce false

positives among licensee employees and

contractors (e.g., administrative errors,

medical prescriptions) are equally likely

to occur during pre-access testing of

applicants for unescorted access. (Note

that a change to § 26.24 will permit

licensees to consider any test meeting

the Part 26 standards as a pre-access

test. Those standards include the

appeals process under § 26.28, and

apply to any test that the licensee plans

to subsequently use as a pre-access test.)

If applicants for unescorted access are

not provided an appeals process, it is

possible that some of them will be

effectively barred from the industry

based on test results erroneously

determined as positive. Providing

applicants an opportunity to appeal the

validity of the test result would also

enhance program credibility.

The NRC also proposes to clarify the

contents and purpose of the notice to

the individual determined to have

violated an FFD policy, clarify that the

review process must be objective and

impartial, clarify that the individual

may submit additional relevant

information, extend appeal rights to

applicants for access, and assure that

relevant records are corrected if an

appeal is successful. The NRC

understands that, in some cases, the

individual did not understand the

purpose of the appeal process. The NRC

also understands that, in many

instances, persons responsible for the

initial determination were conducting

the review. The NRC believes that the

effectiveness of the FFD program

depends, to a large extent, on the

perception by the workforce that the

program is fair and worthy of their

support, and that all reasonable efforts

are being made to ensure that any

decisions that could affect their careers

are fair and based upon information that

is complete and accurate and forms a

sound basis for the decision. The use of

even-handed, fact-finding procedures

should ensure that incorrect

determinations that could undermine

the quality of a licensee’s workforce

and, thereby, be counter to the interests

of safety, will not stand uncorrected.

As a related concern, the NRC has

been informed that some licensees have

required individuals to pay for the

reanalysis of their specimen and the

analysis of their split sample when

pursuing appeals. Having to pay for the

reanalysis can be expected to obstruct

the individual’s exercise of the right to

appeal the licensee determination of

policy violation as granted by this

section. The NRC, therefore, considers

requiring persons covered by the rule to

pay for reanalysis of their specimen or

analysis of the split sample to be

inappropriate. However, requiring the

person to pay after the fact should these

subsequent tests also be positive would

be an acceptable measure to control

unwarranted appeals.

Section 26.29 Protection of

Information

The NRC proposes to amend this

section to clarify that contractors and

vendors who legitimately seek

information for unescorted access

decisions by licensees are authorized to

obtain this information. Contractors and

vendors were unintentionally omitted

from this provision in the original rule.

A second proposed amendment

would allow disclosure of personal

information collected in compliance

with the rule to presiding officers of

judicial or administrative proceedings

that are initiated by the person who is

the subject of the information. The

purpose of this amendment would be to

allow disclosure to, for example, state

agencies investigating whether the firing

of an employee was justified in order to

determine unemployment compensation

entitlements. This disclosure would be

permissible as long as the subject

employee initiated the proceeding.

Section 26.29(c) would be moved

from current § 3.2 of Appendix A and

amended to clarify that licensees must

provide to the subject individual, upon

written request, copies of all records

pertaining to violations of FFD policy,

including test results, MRO reviews,

and management determinations

pertaining to the individual. Some

licensees have interpreted this section

in ways that make it difficult for

workers to obtain their records. For

example, some licensees have allowed

the tested persons to see the documents

but have not provided them copies of

the documents. This is particularly

difficult in the case of contractor

employees who may no longer reside in

the plant area. These actions are

contrary to the NRC’s intent that

persons covered by the rule have full

and convenient access to documents

pertaining to employment actions taken

in response to the results of tests

conducted under this rule.

Section 26.70 Inspections

The NRC is proposing to revise this

section to clarify its intent that FFD

service contractors must make available

for inspection by duly authorized

representatives of the Commission

documents, records, and reports related

to the FFD services they provide to

licensee, contractor, or vendor FFD

programs. In some instances, contracted

service providers and testing laboratory
21118 Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules

personnel have been reluctant to

provide documents to NRC inspectors.

Section 26.71 Recordkeeping

Requirements

The proposed amendments to this

section would clarify the NRC’s intent

that licensees retain relevant records

pertaining to determinations of FFD

policy violations, not just records of

confirmed positive test results. These

records are to include those related to

personnel actions following policy

violation determinations (such as

refusals to test and subversion of the

testing process) as well as those

pertaining to the testing process that

detects the violations. This revised

wording would clarify licensees’

recordkeeping responsibilities as well as

ensure that people covered by the rule

would have sufficient access to

documentation of personnel actions that

can substantially affect their work

status.

The proposed amendments to this

section would also reduce the reporting

frequency for program performance data

from semiannually to annually and add

the number of subversion attempts by

type to reporting requirements to

support the greater emphasis on

subversion elsewhere in the proposed

rule. The NRC has considered, but

decided not to adopt, a recommendation

that utilities with more than one site

submit only a single semiannual

program performance report for all sites.

Such consolidation of data would

prevent analysis of site specific

performance and NRC inquiry into

obvious inconsistencies such as large

numbers of positive results at one site

and no positives at the second or

neighboring site.

Despite obtaining the FFD

programmatic performance information

that has been submitted pursuant to this

section for the five years of program

operation, the NRC believes that

additional types of information could be

useful in fulfilling its responsibilities of

overseeing licensees’ FFD programs and

formulating public policy. As noted in

the introduction to this notice, several

parties have recommended that the NRC

consider obtaining certain types of

information in addition to those

currently required by this section or

now being proposed for inclusion under

§ 26.73. Such information could include

the number and nature of grievances,

arbitration proceedings, and lawsuits

stemming from FFD-related issues;

information related to licensees’ EAP

programs including types of services

provided, whether such services are

provided by licensee or contractor

personnel, employee-to-counselor

ratios, the number of personnel who are

admitted to EAP programs by self

referral and by supervisory referral, the

reported and diagnosed problems, and

overall results of EAP programs; and

laboratory testing results that are being

provided to MROs and what problems

MROs are having in interpreting test

results and making judgments as to

whether FFD policy violations have

occurred.

Having access to this information

would enable the NRC to gain a clearer

and more detailed understanding of the

actual operation of the programs. This

information would also be useful for

purposes of revising the regulation or

providing guidance so that the general

performance objectives stated in § 26.10

can be better achieved. The NRC,

therefore, seeks public comment as to

whether § 26.71(d) should be revised

further to require that these types of

information be collected and analyzed

by licensees and submitted to the NRC.

The NRC also seeks public comment as

to whether the NRC should develop a

management information system similar

to that promulgated by DOT and its

operating administrations (58 FR 68194

through 68285; December 23, 1993).

The NRC wishes to acknowledge the

usefulness of lessons learned and

program initiatives reported by many

licensees that are summarized in

NUREG/CR–5758 each year for licensees

to consider and use to improve their

programs and avoid common problems.

Section 26.73 Reporting Requirements

The current rule requires that

licensees inform the Commission of

significant FFD events and describes

examples of significant events involving

acts by licensed operators and

supervisors that must be reported to the

NRC. Item 10.1 of NUREG–1385

emphasized that the NRC expects

licensees to exercise prudent judgment

on whether or not unusual situations

should be reported and that the

significant events were not limited to

the examples contained in the rule.

However, the NRC understands that

many significant events that would be

useful for formulating public policy or

that the NRC should respond to in a

timely fashion have not been reported

because licensee management decided

not to report the event unless it was

specifically required by the rule.

Therefore, the NRC is clarifying that

significant events are not limited to

those listed and provides additional

examples. One of the proposed

amendments would add FFD program

personnel, in keeping with clarifications

to the scope of the regulation under

§ 26.2 (a), as a class of individuals

whose improper acts would be

reportable. Another proposed

amendment would expand an example

to include that any violation of FFD

policy (e.g., possession of illegal drugs,

refusal to take a test, attempt to subvert

the testing process) by a supervisor,

licensed operator, or FFD program

personnel must be reported in contrast

to the current example which describes

reporting only confirmed positive test

results.

Section 26.80 Audits

This section would be revised to

permit licensees some discretion in

conducting audits and to address a

petition for rulemaking (PRM–26–1)

filed on January 19, 1994. Rather than

emphasizing compliance with a

requirement to conduct an audit at a

fixed annual frequency, licensees would

be responsible for determining the

appropriate frequency, scope, and depth

of auditing activities within a 3-year

period based upon a review of program

performance indicators. These

performance based audits would be

conducted so that all program elements

are adequately covered at least once

during the 3-year period. In addition,

the interval between audits of a program

element would be relaxed to 36 months.

The NRC is specifically interested in

public comments on program

performance indicators in addition to

those contained in the text of the

proposed amendment to the rule and

whether they should be added to the

rule or included in a guidance

document. This relaxation of audit

requirements would not be extended to

contractors and vendors, whether they

are implementing any portion of a

licensee’s program for their employees

under the provisions of § 26.23, or

providing contracted FFD services, such

as specimen collection, testing, and

MRO reviews. The amendments to this

section would also clarify that licensees

must continue to audit their HHScertified laboratories on an annual basis.

The NRC recognizes that FFD is an

evolving discipline and that new issues

and problems will continue to arise. In

some cases, turnover of FFD program

personnel further exacerbates the

problems. There is a frequent turnover

in the contracted services, such as

specimen collections, MRO reviews,

and EAP services. Licensee audits have

found many problems that were

associated in some way with personnel

changes. A proposed amendment to this

section would require licensees to audit

program elements that may potentially

be affected by significant changes in

personnel, procedures (e.g., specimen

collection, testing, and MRO reviews
Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules 21119

and reports), or equipment as soon as

reasonably practicable but no later than

12 months after the changes. The

purpose of these focused audits would

be to assure that the change has not

adversely affected the operation of the

particular program element or function

in question. One of the clear lessons of

the early period of this rule’s

implementation during 1989 to 1991

was that licensees that performed early

pro-active audits of their FFD programs

were able to more easily and effectively

correct programmatic problems and

achieve effective program operations

than those that waited the full nominal

12-month period before auditing their

programs. Accordingly, this aspect of

the performance based audit program

would help ensure that whatever

programmatic problems that may result

from significant changes in personnel,

procedures, or equipment will be

detected and corrected on a timely

basis.

Licensee audits of HHS-certified

laboratories continue to find problems.

In one case, the licensee’s auditors had

found sufficient problems in the first

part of an audit to issue a stop-work

order. The laboratory subsequently lost

its HHS certification. Therefore, based

on experiences gained to date, the NRC

continues to believe that licensees must

continue to audit at least annually the

quality of contractor- or vendorperformed program elements,

particularly when such activities are

provided off site or are not under the

direct, daily supervision of the licensee.

With respect to the petition for

rulemaking, which was filed with the

Commission by Virginia Power and

assigned Docket No. PRM–26–1 on

January 19, 1994, the petitioner

requested that the Commission’s

regulations be amended to relax the

existing mandatory audit frequency and

require each licensee to audit its FFD

program nominally every 24 months

instead of nominally every 12 months

with additional audits if performance

warrants.

The petitioner requested the change

based on its contention that the present

requirement is resource intensive but of

marginal importance to safety. The

petitioner’s further basis was that the

industry’s performance in ensuring a

drug-free workplace has been very

effective, the frequency and extent of

auditing should be based on the need to

assess performance, and that the

licensees need increased flexibility to

concentrate available audit resources in

areas of observed weakness rather than

mandatory audits of marginal safety

significance. The petitioner stated that

such a change would be consistent with

audit requirements concerning

operational safety, and that the blind

performance test procedures and the

quality controls required by Section 2.8

of Appendix A to 10 CFR Part 26

provide sufficient controls to ensure

continued reliability and accuracy of the

chemical testing. The petitioner

indicated that its proposed change is not

intended to preclude additional or more

frequent audits if performance trends

indicate additional overview is

necessary.

The NRC believes that its proposed

changes would go beyond that requested

by the petitioner in that the interval for

auditing the FFD program would be 3

years instead of 2, and the actual

interval of the audits would be based

more on need, as demonstrated by

performance, than at a fixed interval.

Therefore, adoption of the proposed

change by the NRC would grant the

petitioner’s request with respect to

audits of licensee programs. However,

the NRC believes that licensees must

continue to vigorously audit contractor/

vendor-performed program elements,

and has maintained the existing

frequency of these audits.

The NRC understands that licensees

have assumed that the term ‘‘audit’’ in

Part 26 means a quality assurance (QA)

audit that conforms to their normal

audit program requirements and

American National Standards Institute

(ANSI) standards, such as ANSI N45.2,

‘‘Quality Assurance Program

Requirements for Nuclear Facilities,’’

ANSI N45.2.12, ‘‘Requirements for

Auditing of Quality Assurance Programs

for Nuclear Power Plants,’’ ANSI

N45.2.23, ‘‘Qualifications of Quality

Assurance Program Audit Personnel for

Nuclear Power Plants,’’ and ANSI

N.18.7, ‘‘Administrative Controls and

Quality Assurance for the Operational

Phase of Nuclear Power Plants.’’ The

NRC does not require that these audits

be performed by the QA organization in

accordance with the QA program

commitments for the conduct of audits.

As stated in the current rule, the NRC

expects that these audits must be

conducted by individuals who are

qualified (technically competent) in the

subject(s) being audited and are

independent of the program (to assure

objectivity and no conflict of interest).

At the licensee’s option, the QA

organization may perform, lead, or assist

in these audits.

The following discussion describes

the changes to Appendix A to Part 26

that are being proposed and the reasons

for the changes.

Section 1.1 Applicability

Numbering changes to this section are

being proposed to ensure uniform style

and format throughout the rule.

Section 1.2 Definitions

Proposed changes to this section

include deletions of defined terms that

are either redundant with definitions in

§ 26.3, were moved to § 26.3, or are clear

in the context of this Appendix. A

proposed revision would define ‘‘limit

of detection’’ (LOD) which is now used

in the rule. Another proposed

amendment would delete the term

‘‘permanent record book.’’ This change

would make the Appendix consistent

with recent amendments to the HHS

guidelines and the Department of

Transportation FFD regulations that

eliminated the requirement for a

permanent record book. Because HHS

no longer requires a permanent record

book, the NRC proposes to remove

requirements for a permanent record

book throughout the rule. The

permanent record book was originally

required based on the belief that such a

book was necessary to ensure that

critical information regarding collection

and testing of each individual specimen

was recorded. However, the FFD drug

testing program specified in Part 26

requires that all information on

individual tests be recorded on the

chain-of-custody form and other forms

and requires that all information related

to determining violations be retained for

five years. Therefore, there is no

compelling need to maintain a separate

longstanding record book. Eliminating

this requirement reduces the regulatory

burden on licensees and increases the

efficiency of licensee drug testing

programs (because the time taken to

enter information into the record book

while the testee waits is eliminated).

The elimination of this requirement

does not preclude licensees from

making their own determination of the

advantages of the use of a permanent

record book and deciding to continue to

maintain one. A definition of ‘‘limit of

detection’’ has been added to support

some of the several proposed changes

intended to cope with subversion of the

testing process and to protect

individuals from incorrect allegations of

such attempts.

Section 2.1 The Substances

The NRC proposes to amend this

section to include return-to-duty testing

and to clarify that when a licensee tests

for any illegal drug during a for-cause

test or analysis of a suspect specimen

(currently permitted by the rule), the

licensee may consider any detected
21120 Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules

drugs or metabolites (as currently

authorized in section 2.7(d) of this

Appendix for samples suspected of

adulteration or dilution). The NRC

deems it appropriate, in these particular

instances, where reasonable suspicion

of an FFD problem exists, to allow close

scrutiny at the discretion of the licensee.

The licensee continues to be responsible

for assuring that the results establish a

valid basis for any action taken.

The NRC has given consideration to

adding additional substances to the

panel of drugs to be tested (e.g.,

benzodiazepines, barbiturates, and/or

LSD) but has chosen not to add

substances at this time. In the interests

of developing and maintaining a

coherent and well-organized drug

testing program, the NRC anticipates

continuing to follow the lead set by

HHS in its guidelines. HHS reviews the

panel of drugs from time to time from

a national perspective. At this time, the

NRC prefers to have any new additions

to the minimum required drug panel

dependent on HHS first adding

substances to its panel of drugs to be

tested. However, should the interest of

public health and safety indicate a need

to add substances to the drug panel, the

NRC will take appropriate, timely

action. The NRC continues to expect a

licensee to consider any localized

patterns of substance abuse when

designing its FFD program, as required

by § 26.24(c).

Section 2.2 General Administration of

Testing

Section 2.2(a) would be amended to

clarify that licensees may dispose of

chain-of-custody forms associated with

FFD policy violations after 5 years and

need not retain chain-of-custody forms

recording no FFD violations or other

anomalies after appropriate summary

information has been recorded for

program administration purposes.

Licensees recently pointed out that

current rule does not permit destruction

of these records and that they have

started to accumulate an appreciable

volume of files. The retention of records

for 5 years following termination of

unescorted access would provide

appropriate records for responding to

background investigation inquiries

while reducing the storage burden on

licensees. Proposed modifications to

section 2.2(d)(4) would clarify that the

optional blood test for alcohol misuse is

intended for use in a subsequent appeal

of a confirmed positive alcohol test. By

asking for a blood test, the individual is

asking for information that can be used

to appeal a licensee’s determination of

an FFD policy violation.

Section 2.3 Preventing Subversion of

Testing

The proposed amendments to this

section would clarify the individuals for

whom appropriate background checks

and psychological evaluations are

required and would reduce the required

frequency for those activities from every

three years to every five years. These

changes were made in response to

licensee experience and for consistency

with generally accepted security

practices for reinvestigations into

reliability and trustworthiness. This

section also contains clarifications that

would conform with proposed revisions

to § 26.2 that would clarify the

Commission’s original intent that FFD

program personnel responsible for the

administration of testing would meet

the highest standards for honesty and

integrity and be under the drug and

alcohol testing requirements of the rule.

These additions specify that testing of

FFD program personnel shall, to the

extent practicable, be done by personnel

independent of the FFD program. Rather

than describe in the rule how this

requirement should be implemented,

the NRC recommends that the random

selection process, specimen collection,

and testing services could be considered

for performance by licensee employees

specifically qualified for these

infrequent duties, persons under

contract to meet this requirement, or an

exchange of services arranged among

sites or utilities in the same

geographical area. Alternatively, if a

licensee maintains FFD programs both

on site and at corporate headquarters,

the FFD personnel who administer the

program at headquarters could

administer the testing of on-site FFD

personnel and vice versa.

This requirement is intended to

reduce the possibility of FFD program

personnel being responsible for testing

themselves or their close colleagues.

Unless otherwise specifically covered

by the rule, personnel selected to test

FFD program personnel would be

independent of the administration of the

FFD program to the extent practicable.

Section 2.4 Specimen Collection

Procedures

The NRC proposes a number of

changes in this section to increase the

clarity and consistency in the wording

of the rule. In addition to minor

editorial changes, the NRC proposes to

clarify that there is no requirement for

the courier’s signature to be included on

the chain-of-custody form (§ 2.4(d)).

Because specimens are sealed in

packages that would indicate any

tampering during transit to the

laboratory, and couriers, express

carriers, and postal service personnel do

not have access to the custody and

control forms, there is no need for such

personnel to document the chain of

custody for the package during transit.

This is in keeping with standard

forensic laboratory procedures and

would streamline the specimen

transportation process. This is also

consistent with a recent revision to the

HHS guidelines.

In regard to suggestions that the NRC

specify actions to be taken if there is a

break in the chain of custody, the NRC

is aware that the Department of

Transportation and HHS have published

guidance that addresses the proper

handling of breaches in the chain of

custody in the transportation industries.

The NRC believes this type of guidance

is not necessary in the rule but expects

that licensees would take action to

discover and correct problems with the

custody and control of specimens.

Licensees should be aware that, when

actual breaks in a specimen’s chain of

custody are detected and confirmed, the

test result associated with that specimen

must be invalidated. The NRC notes that

judicial rulings indicate that minor

‘‘administrative’’ problems should not

be considered breaks in the chain of

custody. Examples include failure to

include a middle initial or one digit of

a social security number being incorrect,

which are among the many techniques

used in attempts by individuals to

invalidate tests. Another

‘‘administrative’’ example found by the

courts not to be a break in the chain is

the collector and donor leaving a sealed

specimen bottle unattended for

approximately 1 minute with reasonable

measures in place to conclude that no

person had access during that period.

This should not be interpreted to mean

that the courts will accept sloppy

collection procedures. The Commission

expects that licensees will be

sufficiently diligent and attentive to

detail in this matter. The NRC would

also note that licensees that test urine

specimens for the five drugs specified in

Appendix A to Part 26 at the specified

concentration levels can use the OMBapproved Federal Drug Testing (chainof-custody) Form (OMB Number 9999–

0023) developed by the Department of

Transportation and HHS and published

in the Federal Register on August 19,

1994 (59 FR 42996). Licensees that test

for additional drugs or use cutoff levels

different than established by HHS in its

laboratory certification program may not

use the OMB approved form, but should

use a ‘‘look alike’’ form.

That the collection site person shall

note on the chain-of-custody form any
Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules 21121

unusual behavior or appearance of a

person being tested remains a

requirement of Section 2.4(g)(9). The

NRC has noted and considered the

privacy considerations associated with

this requirement and continues to

believe that the need to take note of

such behavior or appearance is an

appropriate part of the testing process.

Clarification to Section 2.4(f) would

assure that a specimen of questionable

validity would constitute a reason to

believe the individual may alter or

substitute a specimen.

In accordance with HHS Guidelines,

the NRC proposes to eliminate the

directive that tested individuals be

provided an opportunity to set forth on

the chain-of-custody form information

concerning medications taken or

administered in the past 30 days

(Section 2.4(g)(4)). The availability of

such information does not eliminate the

need to do a confirmatory test on an

unconfirmed positive screen test result.

This information becomes useful only at

the point at which the MRO reviews a

confirmed positive test result. It is at

this stage, when this information can be

conveyed by the tested individual

directly and confidentially to the MRO,

that information about medications the

person may be using or has used

becomes germane to determining

whether a fitness-for-duty policy

violation has occurred. Eliminating the

opportunity for the tested individual to

provide this information on the chainof-custody form would enhance the

individual’s privacy interests by

precluding the chance of any testing

program or licensee personnel other

than the MRO learning of the

individual’s use of medication.

The NRC proposes to amend Section

2.4(g)(10) to allow licensees to have an

individual, other than a collection site

person, accompany an individual into a

rest room not in the designated

collection site if the designated

collection site is inaccessible. The NRC

also proposes to amend Sections

2.4(g)(15) and 2.4(g)(24) to allow

licensees to have an individual, other

than a collection site person, observe

the collection of a specimen whenever

there is reason to believe the individual

may have altered or substituted the

specimen. However, the requirement

that the individual be of the same

gender as the employee still exists. This

proposed change is based on NRC’s

belief that it not always possible, under

all circumstances, to have a collection

site person of the same gender available.

These revisions are consistent with the

June 1994 changes to the HHS

guidelines.

The NRC proposes reducing the

required urine specimen quantity from

60 milliliters (ml) to 30 ml for the

primary specimen and, when split

specimens are collected, to require the

collection of an additional 15 ml

(Section 2.4(g)(11)). This change

conforms with recent revisions to the

HHS guidelines. Because some licensees

conduct on-site testing and test for

additional drugs, they may need to

collect an additional volume to meet

these needs. The NRC understands that

laboratories require only a few

milliliters for testing and that a 30 ml

sample is sufficient in volume for both

immediate testing and for the retention

of a second aliquot for further testing, if

necessary. The NRC also understands

that accurate measurement of specimen

temperature is difficult with a small

volume but does not believe that

‘‘partial’’ specimens should be disposed

of and not tested. Reported experience

in other industries indicates that the

consumption of water by those unable

to give a urine specimen should be

limited to one 8-ounce glass of water

every 30 minutes but not to exceed a

maximum of 24 ounces. This rate would

protect the health of individuals who

are providing specimens and is

consistent with the recent revision to

the HHS guidelines.

The NRC proposes changes to the

collection procedures to ensure that a

urine specimen is not adulterated or

diluted and to detect surrogate samples

being submitted. Licensees have

reported several examples of specimens

being adulterated or diluted and

surrogate samples being submitted. This

experience is consistent with that of

other workplace programs discussed at

HHS’s Drug Testing Advisory Board

meetings. These recommended changes

reflect the NRC’s desire to minimize the

vulnerabilities in the collection and

testing of urine specimens that

substance abusers have exploited. In

addition to limiting the time between

notification and collection

recommended in § 26.24(e), the first

proposed change in the collection

procedure in Section 2.4(g) would

provide clearer guidance that an

observation of a urine specimen for

color and clarity be used to identify

only obvious signs of adulteration

(Section 2.4(g)(14)). Urine color and

clarity are affected by a wide range of

physiological changes including an

individual’s health, level of hydration,

medications, and diet. Test personnel

should therefore use observation of

color and clarity of the specimen only

for gross signs of adulteration. These

may include crystals settled in the

bottom of the container, off-colors such

as blue or green, and an excess of

bubbles when the container is shaken.

The second proposed change (Sections

2.4(g)(13) and 2.4(g)(15)) would

establish a narrower temperature band

for acceptable urine specimens, with a

minimum temperature of not less than

34°C/94°F (now specified in whole

numbers in accordance with HHS

guidelines). This should make attempts

to submit surrogate samples more

difficult and, together with other

changes, would be consistent with

practices by a few licensees that have

produced good results. The third

proposed change would allow licensees

to set their own parameters, within the

range set by the rule, of the accepted

urine temperature range. This increased

flexibility recognizes that there are a

number of acceptable options for

recording temperature and that each

allows different minimum and

maximum acceptable readings. For

example, some temperature recording

devices are located in the specimen

container and record a ‘‘peak’’

temperature immediately. The

temperature that is expected to be

recorded by this device is close to core

body temperature—a temperature that

could occasionally require a second

specimen under direct observation

under the current rule. The current

temperature requirement is based on a

method that records the temperature

several minutes after the specimen

leaves the body. The range of

temperatures (i.e., the spread between

the minimum and maximum acceptable

temperatures) must be limited as

specified in the rule. The type of

temperature reading device, and the

acceptable range of temperature for that

device, must be specified in the

licensee’s procedures. Two other

proposed changes would reduce the

likelihood of undetected tampering by

requiring secure sealing of specimen

bottles and, in accordance with HHS

guidelines, shipment in tamper evident

containers.

The NRC proposes two changes in

this section with regard to testing for

alcohol (Section 2.4(g)(18)). First, the

NRC proposes to remove the

requirement that the worker undergo a

second breath test for alcohol when the

first test is essentially zero (less than

0.01 BAC). The licensee may, at its

discretion, collect and measure the

breath a second time. This change

reduces the impact on individuals being

tested and on the licensee by reducing

the amount of time taken by the testing

process. It has been determined that a

second negative test result is not
21122 Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules

technically necessary. Second, the NRC

recognizes that alcohol is metabolized

relatively quickly (nominally 0.015

percent BAC per hour) and proposes to

make explicit that the length of time

between a confirmed positive breath test

for alcohol and the drawing of a blood

specimen to test for purposes of appeal

must be minimized. This proposed

amendment would require that the

interpretation of the results of such a

test must consider the time elapsed

between the confirmed positive breath

test and the drawing of blood for use in

an appeal process.

Section 2.4(g)(24) [formerly (25)]

would be revised to provide flexibility

in internal reporting and actions when

an individual fails to cooperate.

The NRC proposes making various

revisions to the requirements for

specimen preparation and

transportation to the HHS-certified

laboratory or to the licensee’s testing

facility to decrease the chance that

specimens will be degraded between the

time they are collected and the time

they are screened and confirmation

tested (Section 2.4 (i)). Reports from

several licensees have suggested that

specimen degradation during shipment

has been the cause of ‘‘false negative’’

test results. The NRC has been advised

that specimens not kept chilled during

storage or transit may have become

contaminated because of the buildup of

bacteria and their wastes to an extent

sufficient to possibly alter laboratory

test results. Information on this

phenomenon is limited and there are

conflicting opinions regarding the

seriousness of the problem. For

example, one MRO stated that 19 of 21

on-site screening test positives were not

confirmed because of degradation of the

samples during shipment. (See

Appendix B to NUREG/CR–5784.) Also,

the reasons for unsatisfactory results of

blind performance tests reported by the

HHS-certified laboratories are that the

blind specimens degraded below the

cutoff levels or that the specimen

containers adsorbed some of the drugs

or metabolites. Therefore, the NRC has

conducted pilot tests to gain additional

insight on whether specimen

degradation was a problem. These pilot

tests detected a significant level of

cocaine metabolite deterioration when

urine specimens with a high relative

acidity/alkalinity (pH) level were stored

at relatively high temperatures (i.e.,

100°F) for 36 hours or more. A modest

study by one licensee showed a definite

decrease in the concentration levels of

THC in specimen bottles stored at room

temperature for one week (e.g., from 199

to 178 ng/mL); where the specimen was

allowed to touch the inside of the cap

sealer, the concentration was reduced

more than one half (e.g., from 199 to

77.8 ng/mL). The NRC specifically

invites comments regarding the

proposed revisions concerning

specimen degradation and whether rule

changes should be made or the

information published in report form for

voluntary use. In particular, the NRC is

interested in data that licensees

conducting on-site testing could

provide. Of specific interest would be

examples of on-site unconfirmed

positives that had degraded during

shipment. Licensees or other parties

submitting such information should

include any known factors, such as

temperatures and duration of exposure

to the suspect condition, that may have

contributed to the problem.

At this time, the NRC proposes two

specific revisions intended to address

this specimen degradation problem. The

first revision would continue to require

that urine specimens be shipped to the

HHS-certified laboratory within six

hours of collection or cooled to not

more than six degrees centigrade

pending shipment (as previously

required by 2.7(c)). The second revision

would require that the time between

specimen shipment and receipt of the

specimen at the HHS-certified

laboratory not exceed 48 hours, or that

the time between shipment and the

screening test at the HHS-certified

laboratory not exceed 72 hours.

The NRC proposes several other

minor editorial revisions to Section 2.4

in response to industry experience.

These revisions do not substantially

alter the intent of the original rule.

Changes to Section 2.4(i) would

simplify the tracking system for the

courier and the laboratory. The NRC

proposes that collection personnel

should report incidents when an

individual refuses to cooperate in the

testing process to an appropriate

authority (Section 2.4(j)), as designated

by the licensee, rather than through the

MRO to appropriate management. The

NRC believes the MRO need not be a

key player because refusals to cooperate

are administrative concerns rather than

medical problems.

Section 2.6 Licensee Testing Facility

Personnel

A change conforming to the HHS

guidelines is proposed to assure that

training of licensee testing facility

managers includes maintenance of

chain-of-custody.

Section 2.7 Laboratory and Testing

Facility Analysis Procedures

Proposed revisions to this section

further clarify wording and procedures

discussed in previous sections.

The NRC proposes several changes in

this section that would be consistent

with the recent revisions to the HHS

guidelines. The NRC proposes to reduce

the screening cutoff level for marijuana

from 100 nanograms per milliliter (ng/

ml) to 50 ng/ml (Section 2.7(f) formerly

2.7(e)). Current testing technology is

capable of supporting reliable and valid

results at this level. In addition, analysis

of results in nuclear industry drug

testing programs shows that positive test

rates (indicating increased detection)

increased substantially when the

screening level was lowered to 50 ng/ml

from 100 ng/ml. These proposed

changes would make the NRC’s FFD

rule consistent with the HHS Guidelines

(59 FR 29908; June 9, 1994) and the

cutoff levels used by all other Federal

agencies. This change is needed to

ensure that licensees’ specimens are

tested by a process certified by HHS

(any cutoff level different than the HHScertified process must be accompanied

by appropriate QA measures). The NRC

proposes a revision to eliminate the

requirement that test results be reported

in batches (Section 2.7(h)(1)). In

addition to being consistent with the

recent revisions to the HHS guidelines

and the current general practice, this

would significantly decrease the amount

of time required for licensees to receive

certain types of test results from the

laboratory.

The NRC proposes to clarify its

original intent that licensees which

retain split specimens must use a

different HHS-certified laboratory in

cases where a split specimen is being

tested for an appeal (§ 2.7(k)). The NRC

was informed by HHS that requiring a

different laboratory essentially

guarantees a different process for

preparing the specimen which would

provide a high assurance of detection of

any laboratory error or inaccuracy of test

results. In one instance, the same

laboratory that produced a positive test

retested the specimen during an appeal

and, using the same method, made the

same mistake and produced a second

false positive test. The false positive was

discovered in response to repeated

appeals by comparing this laboratory’s

results with the results reported by

another laboratory. Although suspected

false positives have been extremely rare,

this proposed revision would further

reduce the possibility for recurrence of

a false positive due to a laboratory error.
Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules 21123

The NRC is proposing a number of

revisions to this section aimed at

enhancing the effectiveness and

reliability of licensee FFD program by

requiring testing to determine the

validity of specimens; this adaptation of

a recent change to the HHS guidelines

would detect evidence of adulteration or

dilution, thereby reducing the potential

for subversion of the testing process.

This change would also address

concerns that the rule does not require

the laboratories to report the results of

tests, such as pH, specific gravity (SG),

and creatinine, to the extent these tests

are performed. Licensees have

encountered various practices, such as

adulteration and dilution, by substance

abusers to avoid detection and the NRC

desires to minimize the vulnerabilities

in the testing process that have been

exploited. One of these measures would

be to determine specimen validity.

Licensees conducting onsite testing

would be required to determine the

validity of all specimens collected; this

would avoid disposal of specimens that

would have been determined invalid by

the laboratory. The validity of the

specimens would be determined

through the addition of testing for

specific gravity on arrival of the

specimens at the licensee’s onsite

testing facility or the HHS-certified

laboratory (Section 2.7(e)). The NRC

requests comments on whether these

tests for determining specimen validity

should include tests for acidity/

alkalinity (pH), creatinine, and other

tests for adulterants and whether these

tests should be conducted as part of the

collection process so that a second

specimen can be collected immediately

and under direct observation. To protect

those being tested from incorrect

conclusions about the validity of a

specimen, the NRC is proposing that

those specimens determined to be

outside of specification would be

subjected to both screening and

confirmation tests at the limit of

detection that the laboratory is capable

of performing. The NRC understands

that this may not be technically feasible

for specimens containing some

adulterants. In those cases, the

laboratory would not test to limit of

detection (LOD) and would report the

specimen condition. The NRC

understands that some HHS-certified

laboratories have an LOD much lower

than the established cutoff values, while

others may not be able to achieve an

LOD less than 40 percent of established

cut off levels. Therefore, the NRC

requests comments on the desirability of

requiring that tests of specimens which

are outside of specifications (i.e., show

evidence of adulteration or dilution) be

performed at the HHS-certified

laboratory’s LOD and depending on

licensees to select laboratories capable

of achieving the lower LODs and to

develop appropriate quality controls.

Recognizing the ability of HHS-certified

laboratories to identify drug metabolites

at lower concentration levels found in

dilute specimens in a forensically sound

manner, the NRC believes this is an

appropriate approach to reducing the

potential for incorrect conclusions about

the validity of a specimen.

The NRC believes that the information

developed during these procedures

would enable the MRO to make an

accurate determination of whether a

specimen of questionable validity has

actually been adulterated or diluted. If

the specimen has been heavily

adulterated or diluted, specimen

validity test results would indicate an

obvious attempt to subvert the testing

process. If the specimen is moderately

diluted, with no drugs detected, and the

worker’s health habits reveal

consumption of appropriate quantities

of liquids, the MRO would determine no

attempt to subvert the testing process. If

drugs are detected, the MRO would

conclude that the worker has attempted

to subvert the testing process.

In keeping with this proposed change

to reduce subversion of the testing

process, the NRC proposes to require (in

Section 2.7(d)) that the Medical Review

Officer report any adulteration or

dilution evidence (excluding hydration

resulting from an acceptable reason) to

licensee management in order to enable

licensee management to more

vigorously pursue subversion attempts

(Section 2.7(h)(1), formerly Section

2.7(g)(1)). Hydration resulting from

acceptable reasons (e.g., drinking fluids

for health reasons) would be excluded

because this type of hydration occurs

frequently, especially in warm climates.

Another revision would add urine

specimens that are determined on site to

be questionable for adulteration or

dilution to those specimens that

licensees must ship to an HHS-certified

laboratory for testing (Section 2.7(d)). By

a related revision, all specimens that

have been adulterated or diluted, or that

the licensee specifies have been

associated with personnel actions for

other reasons, would be subject to longterm frozen storage for at least one year

by HHS-certified laboratories (Section

2.7(i)). The NRC recognizes that these

changes are minor clarifications or

modifications to existing requirements

and understands that many licensees are

currently performing these proposed

actions.

The NRC proposes four changes to the

requirements for testing. First, the NRC

proposes that a test for d (dextro) and l

(levo) isomers of methamphetamine be

required for all positive tests for

amphetamines (an additional two days

are provided the laboratory for

processing specimens suspected of

containing amphetamines) (Section

2.7(g)(6)). Some legal drugs (e.g., Vicks

inhaler) contain amphetamine

compounds that may yield a laboratoryconfirmed positive for amphetamine

use. Laboratory confirmatory tests for

the d and l isomers are able to

differentiate between compounds and to

identify those positive test results that

are the result of legal use. Many

licensees have already been using this

test as further confirmation of positive

test results for amphetamines. This

proposed revision would mandate the

use of this test by all licensees and be

consistent with current laboratory

practice described by HHS in its

Technical Advisory of March 11, 1991.

Second, a new Section 2.7(f)(3) would

permit multiple screening tests only in

certain limited situations. This would

adopt with some modification a 1994

change HHS made to its guidelines

which is intended to be limited to

amphetamines to reduce the effect of

possible cross reactivity due to

structural analogs, and to unique testing

problems. However, a few licensees

have expressed concern when they

learned their laboratory was routinely

using multiple screening tests on all

specimens. Multiple screening tests

should not be used on a routine basis

because of the increased number of false

negative test results that could occur.

Third, the NRC is also proposing to

reduce the time that licensees must wait

for laboratories to provide testing results

and, thereby, enable licensees to grant

unescorted access to new employees

and to conclude activities related to

drug testing in a more timely manner

(Section 2.7(h)(1)). It is the NRC staff’s

understanding that most HHS certified

laboratories can, and usually do, report

negative results to the licensee within

24 hours of receipt of specimens. A

laboratory-confirmed positive result

usually requires another 24 to 48 hours.

Exceptions are when a positive test

result for amphetamine requires further

testing for d and l isomers or an opiate

positive requires further testing for 6-

acetylmorphine (6-AM) at a few

laboratories. The reduced period of time

provided to laboratories to report results

assures that licensees will receive

results in a timely manner and will

reduce the time that new employees

will have to wait for their unescorted
21124 Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules

access, thereby reducing costs to the

licensee. Fourth, the NRC proposes to

require that a methamphetamine

confirmatory test result contain at least

200 ng/ml of amphetamine for the result

to be reported as a laboratory positive

(Section 2.7(g)). This revision would

conform with a similar change made to

the HHS Guidelines on June 9, 1994 (59

FR 29908). This requirement was

adopted by HHS to prevent false

positive methamphetamine results that

can be caused by chromatographic

resolution problems in the confirmatory

testing process.

In a related matter, the NRC

understands that a significant

percentage of laboratory-confirmed

positives for opiates are determined to

be negative by the MROs based on use

of prescription medication, poppy seed

consumption, no clinical evidence, or

other reasons. In several public

meetings, MROs and other FFD program

personnel have expressed concern that

the current opiate testing levels are not

properly targeting opiate abusers. The

concern is that the program is not

effective in deterring or detecting heroin

use (the rule requires clinical signs of

abuse for the MRO to determine the test

result as positive, yet heroin is

frequently smoked or inhaled leaving no

clinical signs of abuse), and large

numbers of laboratory confirmed

positives for opiates are determined

negative, which imposes an unnecessary

burden on the MROs and costs to the

licensees. Data from eight licensees

summarized in Table 3.12 of NUREG/CR

5784 indicate that only 2 of 124

laboratory-confirmed opiate positives

were confirmed by MROs as positive

(both of these positive results were

reported by one licensee). These data

are consistent with anecdotal reports

from HHS and DOT officials and MROs.

The NRC understands that the

Department of Defense (DOD) has raised

its screening test cutoff level for opiates

to 2,000 ng/ml and the confirmatory test

cutoff levels for morphine to 4,000 ng/

ml, codeine to 2,000 ng/ml, and 6-AM

(a metabolite specific for heroin) to 10

ng/ml.

The NRC is specifically interested in

public comments and supporting data as

to whether it should raise the cutoff

levels for screening and confirmation

tests for opiates. Should the NRC set its

levels consistent with those set by the

DOD and proposed by HHS on

November 16, 1995 ( 60 FR 57587)?

Given the level of concern for safety in

the nuclear industry, should the NRC

retain the current levels?

Two revisions related to the shortterm refrigerated storage of specimens

are also being proposed (Section 2.7(c)).

This section currently requires that

specimens that do not receive a

screening test within seven days of

arrival at the HHS-certified laboratory

be chilled in secure refrigeration units.

The NRC has determined through pilot

experiments that at least one drug

metabolite is subject to deterioration if

a urine specimen containing this

metabolite is allowed to stand for more

than 32 hours at relatively high

temperatures. The NRC has also become

aware of anecdotal evidence that

indicates that, when specimens are

shipped or stored at warm temperatures,

there is a potential for drug or

metabolite deterioration such that

specimens containing drugs or

metabolites over the cutoff level at the

time they were submitted can be found

to be negative in either screening or

later confirmatory tests. The NRC is,

therefore, proposing to require that

specimens that will not receive a

screening test and, if appropriate, a

confirmatory test within one day of

arrival at the HHS-certified laboratory

be stored in a chilled condition until

tested.

The NRC proposes several

modifications that would clarify or

modify requirements in light of industry

experience. These modifications do not

significantly affect the rule’s original

intent and are intended to reduce

unnecessary problems in the

implementation of the rule. First,

Sections 2.7 (f)(1) and (g)(2), formerly

Sections 2.7(e)(1) and (f)(2), would be

modified to clarify that licensees using

lower cutoff levels are not required to

perform two different tests at different

cutoff levels. Instead, they are expected

to use extrapolation techniques to

provide the required estimates of the

number of positive test results from

HHS-certified laboratories that would

have occurred using the NRC cutoff

level. Second, the NRC proposes to

delete the requirement that licensees

have emergency power equipment

available for refrigeration units in the

event of a power outage (Section 2.7(c)).

Instead, the proposed revision would

require only that licensees have some

kind of contingency measures available

to maintain specimens in a chilled state.

Third, the NRC proposes to allow

routine administrative tasks now

assigned to the MRO to be performed by

the administrative staff of the MRO

(Section 2.7(h)(2)), formerly Section

2.7(g)(2). Licensee experience has found

that the duties of the MRO are extensive

and that many of the duties prescribed

in the rule could be performed equally

well by the MRO’s staff without

compromising the privacy of

individuals. Fourth, the NRC proposes

to make explicit that licensee contracts

with HHS-certified laboratories provide

that the licensee and the NRC should be

able to obtain from the laboratory all

information and documentation that is

reasonably necessary for the licensee’s

inspection or audit of the laboratory,

including, but not limited to, copies of

the laboratory’s HHS certification

results (Section 2.7(n), formerly Section

2.7(m)). In addition, this revision

provides for reduced licensee inspection

activities in those areas currently

inspected under the HHS certification

program. Fifth, the NRC proposes to add

to Section 2.7(n) a provision that would

permit, in the event that a licensee’s

HHS-certified laboratory loses its

certification, the licensee to use for up

to 3 months an HHS-certified laboratory

that has been audited by another NRC

licensee that shares the same drug

testing and cutoff standards. In such

cases, the licensee would be required to

audit the newly contracted laboratory

within three months. Sixth, the NRC

proposes to revise Section 2.7(h)(5)

(formerly Section 2.7(g)(5)) to clarify

that the laboratories, which are now

required to provide expert testimony

covering drug test results, would retain

the originals of the specimen chain-ofcustody form in order to assure that

evidence is available for appeals. The

documents would be retained by the

laboratory consistent with the proposed

retention requirements in Section 2.2(a)

of the Appendix. Seventh, the NRC

proposes to clarify the original intent of

Section 2.7(k) (formerly Section 2.7(j))

with regard to the applicability of the

quantification of test results to split

specimens. In a related matter, the NRC

considered but decided not to adopt a

change to Section 2.7(h)(3) to further

clarify that the laboratory must provide

quantitation of test results to the MRO

when requested. Some laboratories have

been reluctant to provide such

requested information. Eighth, the NRC

proposes to clarify that the individual

must be informed of his/her option to

test the split sample (Section 2.7(k)).

Inspections have indicated that, for

various reasons, not all individuals are

so informed. Ninth, the NRC proposes to

make explicit that all standards used to

calibrate alcohol breath analysis

equipment and equipment used at

licensees’ testing facilities for

conducting screening tests must be

current and valid for their purpose

(Section 2.7(p)(2), formerly Section

2.7(o)(2)). The NRC has received

comments from licensees regarding the

receipt of out-of-date calibration

standards for alcohol breath analysis
Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules 21125

and regarding the inability of some

screening test equipment to test at

required levels. The NRC is also aware

of the deliberate use of expired

calibration standards.

The NRC also proposes to revise

Section 2.7(k) by requiring an

individual’s request that his or her split

specimen be tested in a timely manner.

Current wording of the rule does not

establish a time limit for an individual

to request a test of a split specimen. The

proposed revision would permit

licensees to establish a definition of

‘‘timely,’’ but it could not be restricted

to less than 72 hours from the time the

individual is notified of the violation.

Although recently revised HHS

guidelines established a maximum time

limit of 72 hours, the NRC believes

licensees should be provided the

flexibility to determine appropriate time

limits for split specimen testing requests

that meet particular demands associated

with the licensee’s notification

experience (e.g., notification of result

occurring just before a long holiday

period or the individual out sick). This

revision would also ensure that

individuals’ rights are protected by

establishing the minimum 72 hour

period within which they may make a

request for split specimen analysis.

A proposed revision to Section

2.7(p)(3) (formerly Section 2.7(o)(3))

would allow use of alcohol breath

analysis equipment that conforms to the

September 17, 1993, amendments to the

National Highway Traffic Safety

Administration’s (NHTSA) Model

Specifications for evidential breath

testing devices originally published in

1984. While these amendments reflect

new lower evaluation thresholds for

devices to measure breath alcohol,

licensees need not acquire new devices

that meet these amended standards.

Breath analysis equipment that meets

the 1984 NHTSA standards will

continue to be acceptable in NRC FFD

programs.

The NRC considered a potential

revision to test for agents used to mask

the presence of THC and other drugs.

An analysis of specimens producing

negative screening tests to assure that

they do not contain agents that mask the

presence of THC and other drugs could

be specified by rule. Products that can

be added to urine as masking agents are

currently available and tests for these

products are currently used by some

laboratories. Testing for these products

would increase the detection of attempts

at subverting the testing process. While

it has decided not to propose this

revision at this time, the NRC invites

public comment on both the need for

and the resource impact of such a

requirement.

The NRC has received requests from

several licensees and vendors to permit

the on-site use of non-instrumented

qualitative immunoassay methods that

involve the use of inexpensive,

disposable devices. Convenience and

speed in obtaining results appear to be

the main advantages of these devices.

Such testing does not use laboratory

analysis techniques, can be performed

quickly, and can produce virtually

immediate results. These compact and

portable testing devices show promise

as a quick and easy method for testing

in certain circumstances such as

physician’s diagnostic needs when the

presence of drugs or alcohol can affect

what treatment is suitable for

emergency-room patients. These testing

devices may also be well adapted to

some criminal justice applications,

roadside testing, or testing in remote

locations. They are generally able to

identify the five drugs or drug

metabolites of concern to the NRC.

While Part 26 does not currently

preclude the use of such noninstrumented devices for screening

tests, the NRC is aware that there are

several technical variables involved in

the use of these devices that may

prevent them from achieving the high

levels of specificity, accuracy, and

repeatability demanded in licensees’

FFD drug testing programs. Temperature

and barometric pressure can alter the

amount of urine being tested and the

repeatability of the test. Temperature

variations may affect the reactivity of

the chemical reagents and indicator

strips being used. These effects alter the

amount of urine being tested and the

repeatability of the test. The NRC’s

concern is whether these types of

technical variations will have sufficient

impact to alter the specificity, accuracy,

and repeatability of the test results. The

NRC is concerned that the use of such

devices may lead to a number of false

negative screening test results. (The

concern for false positive screening test

results is minimal since all positively

screened specimens must be tested at an

HHS-certified laboratory and any

positive results from the laboratory

followed by a review of the results by

an MRO.) The Commission believes that

the use of testing devices that might

increase the number of false negative

screening test results is not consistent

with the goals of FFD testing or to the

credibility of the program to those

subject to testing.

The NRC is also concerned that there

are not sufficient procedural safeguards

currently in place that would ensure

reliably accurate screening test results if

these non-instrumented devices were to

be used by licensees. There are, for

example, no quality control procedures

known to the Commission that could be

used to validate the results produced by

the use of these devices, nor is there any

mechanism in place to validate

industry-wide results over time. For

example, accurate tests at the beginning

and end of a batch of specimens tested

with an instrumented test would

indicate all specimens in the batch were

accurately tested. On the other hand,

‘‘batch’’ testing with these noninstrumented devices is probably not

feasible. Likewise, the potential for

subversion that could be introduced by

the use of these devices has not yet been

adequately investigated or addressed.

Requirements may need to be developed

to protect an employee’s right to privacy

and to minimize the chances for

subversion of the testing process. No

procedural safeguards exist in the text of

the rule or in Appendix A that would

address opportunities for subversion of

the testing process which may be

created by the use of these new devices.

Given the uncertainties surrounding

the potential use of non-instrumented

testing devices, the NRC would prefer

that these devices not be used for

screening tests in licensees’ FFD

programs at this time. The NRC is aware

that HHS has been mandated to

investigate the accuracy and reliability

of these devices. The NRC will monitor

the HHS investigation and continue to

pursue its own inquiry into the

feasibility of the use of these devices for

FFD screening tests. As part of this

effort, the NRC will determine whether

new guidelines, quality assurance

procedures, and performance standards

that would govern their use should be

added to Part 26.

To aid in this effort, the NRC invites

public comment on the advisability of

its creating guidelines, procedures, or

standards for non-instrumented testing

devices. The NRC would welcome

specific recommendations as to how

Part 26 could be amended or other

means that would address the concerns

discussed above and other issues

surrounding the use of such devices.

Alternatively, the NRC invites public

comment on the advisability of its

waiting until procedures or standards

governing the use of non-instrumented

testing devices are developed by other

agencies and then evaluating and

adapting those standards to the nuclear

power industry’s requirements. Should

there be a Conforming Products List for

these devices similar to that published

by the NHTSA for evidential breath

measurement devices, and who should

administer such a program? The NRC
21126 Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules

also would be interested in learning

under what conditions, if any, would

the use of non-instrumented drug

testing devices produce cost savings as

compared to licensees’ current means of

screening.

The NRC notes that Section 2.7(h)(4)

(formerly Section 2.7(g)(4)) requires that

HHS-certified laboratories transmit drug

test results to MROs in a manner

designed to protect the confidentiality

of that information. In order to promote

the efficient administration of FFD

programs, it is the Commission’s policy

that FFD program personnel can assist

MROs in the receipt and processing of

the laboratory reports. While some

programs have chosen to require that

test results be received only by their

MROs, others have allowed other

program personnel under the

supervision of an MRO to receive the

results and forward them to the MRO.

The NRC believes that both approaches

are acceptable as long as the procedures

for receiving and handling test results

within the program are designed to

preserve the confidentiality of the test

results and actually accomplish that

purpose. The NRC reiterates that a test

result reported as a confirmed positive

by an HHS-certified laboratory must not

be considered a violation of a licensee’s

FFD policy until such result is reviewed

by the MRO to determine if it

constitutes evidence of such a violation.

Therefore, the procedures through

which the MROs receive test results

from HHS-certified laboratories should

contain explicit safeguards against

improper disclosure of the report and

premature actions such as the

laboratory-confirmed test result being

recorded in the employee’s personnel

file, an employment action being taken,

or licensee management being notified

of the positive result until after the MRO

has determined that there is not an

acceptable medical explanation for the

positive result.

Section 2.8 Quality Assurance and

Quality Control

A proposed revision to Section 2.8(b)

would clarify that the current

requirement that licensee testing

facilities ‘‘process’’ blind performance

specimens means that licensees

conducting on-site testing must perform

an immunoassay test on all such

performance specimens before they are

submitted to the HHS-certified

laboratory. This revision is intended to

make clearer the NRC’s original intent

regarding this requirement. A further

revision would make explicit the

requirement that licensees must

evaluate the results of their HHScertified laboratory’s testing of the blind

performance test specimens and a

sampling of specimens screened as

negative submitted by the licensee and

take corrective action as appropriate.

The NRC, after consulting with

SAMHSA, proposes an adaptation of

recent changes to the HHS guidelines

for blind performance test specimens

(Section 2.8(e)). As HHS did with its

guidelines, the modifications would

reduce the percentage of blind

performance specimens, reduce the

proportion of blind performance tests

relative to the total number of tests

submitted, and reduce the maximum

required number of blind performance

test specimens. These changes are

intended to ensure that the number of

blind performance test specimens

required to be submitted are adequate to

assure quality in the testing process and

particularly in the HHS-certified

laboratory.

The NRC proposes to reduce the

percentage of blind performance tests

from 50 percent to 20 percent for the

initial 90-day period and from 10

percent to 3 percent after the initial

period, consistent with changes made to

the HHS guidelines and the Department

of Transportation’s rules. The maximum

number of blind performance test

specimens required to be submitted

both in the initial 90-day period and

after is also lowered in the proposed

revision. However, the NRC believes a

maximum number less than that

established by the HHS guidelines

would assure adequate quality in the

testing process. Whereas HHS lowered

the maximum number of blind

specimens to be submitted during the

initial 90 day period from 500 samples

to 200, the NRC proposes a further

reduction to 100 specimens. The

maximum number of specimens

submitted thereafter during each quarter

was reduced from 250 to 100 by HHS;

NRC proposes a further reduction to 25

blind specimens per quarter.

Because the NRC permits on-site

testing and very few specimens with

unconfirmed positive test results would

be submitted to laboratories at these

sites, the NRC, in consultation with

SAMHSA, proposes that there should be

a minimum number of blind specimens

(10 per quarter is recommended) to

ensure that a sufficient number are

submitted to assure the quality of the

testing process.

The NRC intends that utilities with

multiple collection sites submitting

specimens to the same HHS-certified

laboratory meet the percentage

requirement for each collection site.

However, a licensee may combine the

number of specimens collected from its

multiple sites to meet the total

minimum requirement for all collection

sites. That is, if one or more of the

utility’s collection sites and the

corporate office contract with the same

laboratory, they may pool their number

of regular test specimens to meet

requirements for the minimum number

of blind performance test specimens.

The NRC expects that blind specimens

will be submitted to the laboratories

from each collection site and that

submission will be uniformly

distributed throughout each quarter to

correspond with the submission rate for

other specimens.

The NRC also proposes to lower the

percentage of blind performance test

specimens which would be blank and

raise the percentage which would be

positive for one or more drugs (Section

2.8(e)(3)). Increasing the percentage of

positive specimens would help offset

the reduction in the minimum

percentage requirements for blind

performance test specimens and would

assure that an adequate number of

positive performance tests for each drug

are submitted for quality control. Also,

the NRC proposes that 10 percent of the

positive blind specimens be

appropriately adulterated or diluted and

‘‘spiked’’ to 60 percent of the cutoff

value to challenge the laboratory’s

ability to determine specimen validity

as proposed in Section 2.7(e) of the

Appendix.

The third proposed revision would

clarify that licensees must investigate

any testing errors or unsatisfactory

performance identified throughout the

testing process or during the appeals

process (new Section 2.8(f), formerly

Section 2.8(e) (4), (5), and (6)). The NRC

intended, in the original rule, that

testing or process errors discovered in

any part of the program, including the

appeals process, be investigated as an

unsatisfactory performance of a test.

Thorough investigation and reporting of

such test results will continue to assist

the NRC, the licensees, HHS, and the

HHS-certified laboratories in preventing

future occurrences.

The NRC also proposes to clarify

Section 2.8(e)(2) by modifying the

reference to ‘‘the initial 90-day period of

any new drug testing program’’ to read

‘‘the initial 90-day period of any

contract with an HHS-certified

laboratory.’’ The clarification would

help assure that intensified quality

testing is performed during the initial

phase of testing by any new laboratory,

as originally intended. (See previous

discussions in item number 10.5.6 of

NUREG–1354 and item number 4.15 of

NUREG–1385.)

The NRC proposes revising Section

2.8(e)(1) by clarifying the criteria that
Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules 21127

licensees must follow when purchasing

blind quality control specimens.

Currently requirements only ensure that

blind quality control materials be

purchased from labs certified by HHS or

a HHS-recognized certification program.

Due to the fact that not all suppliers of

blind quality control materials adhered

to uniform standards for preparation

and certification, unacceptable blind

quality control specimens have been

used. These unacceptable blind quality

control test results, e.g., false negatives

or false positives, lead to increased costs

and lowered efficiency because of

additional tests and follow-up actions

necessary to validate the results of

previously tested actual specimens.

More importantly, the unacceptable

results may tend to cause loss of

confidence in the testing process. In

order to eliminate these problems, the

NRC proposes to explicitly state the

criteria, as HHS did in its recent

revisions to its guidelines, in order to

clarify for licensees the standards for

blind quality control materials and

make the rule consistent with existing

practice.

Section 2.9 Reporting and Review of

Results

The NRC proposes a number of

revisions to this section to clarify the

original intent of the rule.

Section 2.9(d) requires the MRO to

determine if there is clinical evidence of

opiate abuse before verifying a test

result to be positive for that drug

(meaning a clinical examination of all

persons whose specimen was reported

by the laboratory as positive for

morphine or codeine). The NRC has

become aware that some MROs believe

that the opportunity for an individual to

discuss a positive test result and related

matters in a telephone conversation

rather than at a face-to-face interview is

sufficient to comply with this section.

Providing the opportunity for only

telephone conversations in some

situations may not be adequate,

particularly in cases where opiate use is

in question. FFD experience

demonstrates that personal, face-to-face,

contact between the MRO and the

subject individual can play an

important part in arriving at fair and

defensible judgments as to whether a

violation of FFD policy has occurred.

This process will be further clarified in

the near future by HHS through

revisions to its Medical Review Officer

Manual.

The NRC proposes to clarify that the

standards applied to the determination

of whether clinical evidence of opiate

abuse exists would include a range of

evidence, including substantial

evidence of lack of reliability and

results inconsistent with ingestion of

food or medication. Some MROs have

interpreted this section of the regulation

as restricting the types of evidence they

should consider (Section 2.9(d)), in

some cases resulting in ‘‘pro forma’’

rejection of all laboratory positives for

opiates.

With regard to legal drugs, the NRC

proposes to remove the requirement that

Medical Review Officers determine

whether there is clinical evidence of

unauthorized use of over-the-counter

and prescription drugs (Section 2.9(d)).

This requirement has created difficulties

for Medical Review Officers because

there is little guidance that can be

developed regarding what constitutes

clinical signs of abuse for these

substances.

The NRC notes that during the first

five years of program operations, there

has been programmatic inconsistency in

MROs’ decisions concerning the abuse

of legal drugs, such as the use of drugs

prescribed for one’s spouse. This

inconsistency has resulted in significant

variance in management actions taken

in response to this type of drug use. The

NRC is not proposing a revision to this

section. Instead, the NRC expects MROs

to use prudent judgment in dealing with

those situations which raise significant

FFD concerns.

The NRC proposes clarifying that a

medical determination of fitness be

conducted (Section 2.9(g)) in the

following cases: (1) Where there is a

reason to believe that on-duty

impairment may exist (whether or not

there is an FFD policy violation), (2) in

the evaluation of all for-cause tests

results, (3) before making return-to-duty

recommendations, (4) before granting

unescorted access to the protected area

when a record of a prior FFD violation

exists, and (5) if a history of substance

abuse is otherwise identified. The

licensed physician or Medical Review

Officer is to report to licensee

management both determinations of

FFD violations and determinations of

any condition under which an

individual may not be able to safely and

competently perform his or her duties.

These requirements are intended to

increase assurance that a medical

evaluation is performed for

circumstances where fitness may be

questionable. The NRC wishes to

emphasize that the determination of an

impairment problem that does not

constitute an FFD violation must not

result in punitive action toward the

individual.

The NRC proposes to require Medical

Review Officers to review BAC readings

between 0.02 percent and 0.04 percent

and to extrapolate the results of breath

analysis for alcohol, or GC analysis of

blood, back in time when appropriate

(Section 2.9(h)). This would ensure that

individuals who can reasonably be

concluded to have had a BAC at or

above 0.04 percent while on duty will

be found to be in violation of the FFD

policy.

The NRC proposes to revise Section

2.9(e) by clarifying what constitutes a

‘‘timely’’ request by an individual that

an aliquot be reanalyzed. This would be

an adaptation of the timeliness standard

for testing split specimens recently

adopted in the HHS Guidelines.

However, under the HHS approach the

split specimen ‘‘belongs’’ to the donor

and the primary specimen ‘‘belongs’’ to

the employer; therefore, the HHS

guidelines are silent on timeliness for

reanalysis of the primary specimen.

Current wording of this paragraph in the

NRC’s rule requires an MRO to

authorize a reanalysis of the original

aliquot on the timely request of the

individual tested. This ambiguity could

be problematic for licensees who must

determine how ‘‘timely’’ such a request

actually is. The proposed revision

would permit licensees to establish a

definition of ‘‘timely’’, but it could not

be restricted to less than 72 hours from

the time the individual is notified of the

violation. The NRC believes licensees

should be provided the flexibility to

determine appropriate time limits for

requests for retesting specimens that

meet particular demands associated

with the notification of the worker (e.g.,

notification occurring just before a long

holiday period or extended illness), yet

this revision would also ensure that

individuals’ rights are protected by

affording them a minimum of 72 hours

within which they may make a request

for reanalysis of the specimen. In

addition, the NRC is allowing licensees

the flexibility to dispose of test results,

based on scientific insufficiency, after

three years.

The NRC proposes adding a new

Section 2.7(p)(6) and amending Section

2.9(b) by restricting the types of

arrangements that can exist between the

MRO and the HHS-certified laboratory

or the operating contractor of an on-site

testing facility. The NRC proposes to

require that the MRO not be an

employee, an agent of, or have any

financial interest in the laboratory or onsite testing facility operator for which

the MRO is reviewing drug testing

results. Similarly, the laboratory and onsite testing facility operator shall not

have any relationship with the MRO

that may be construed as a conflict of

interest. These restrictions are

consistent with recent changes to the
21128 Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules

HHS guidelines and the NRC believes

that they will assist in eliminating any

conflict of interest between the MRO

and the contract laboratory and on-site

testing facility operator that may affect

the impartiality and objectivity of the

MRO in reporting testing deficiencies or

errors to licensee.

Section 3.2 Individual Access to Test

and Laboratory Certification Results

The NRC proposes to delete this

section and incorporate relevant

portions of it as Section 26.29(c).

Section 4.1 Use of HHS-Certified

Laboratories

The NRC proposes to add a caution,

upon the advice of SAMHSA, that the

HHS certification process applies only

to the drugs and cutoff levels specified

by HHS and that the defensibility of the

results of tests at more stringent cutoff

levels than those required under HHS

guidelines, for analyses of blood

specimens for alcohol, and tests for

substances other than the 5 covered

under HHS guidelines depends on

appropriate measures by licensees to

assure that the reported results are

valid.

Environmental Impact: Categorical

Exclusion

The NRC has determined that this

proposed rule is the type of action

described as a categorical exclusion in

10 CFR 51.22(c)(2). Therefore, neither

an environmental impact statement nor

an environmental assessment has been

prepared for this proposed rule.

Paperwork Reduction Act Statement

This proposed rule amends

information collection requirements that

are subject to the Paperwork Reduction

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

This rule has been submitted to the

Office of Management and Budget for

review and approval of the information

collection and paperwork requirements.

The proposed rule will relax existing

information collection requirements and

will contain new information

collections. The overall effect will also

reduce existing information collection

requirements, and the overall public

burden of this collection of information

is expected to be decreased by 170

hours per year per site. These estimates

for both reduction and addition to

burden include the time required for

reviewing instructions, searching

existing data sources, gathering and

maintaining the data needed, and

completing and reviewing the collection

of information.

The U.S. Nuclear Regulatory

Commission is seeking public comment

on the potential impact of the collection

of information contained in the

proposed rule. Comments to the OMB

on the collection of information or on

the following issues must be submitted

by June 10, 1996.

1. Is the proposed collection of

information necessary for the proper

performance of the functions of the

NRC, including whether the information

will have practical utility?

2. Is the burden estimate accurate?

3. Is there a way to enhance the

quality, utility, and clarity of the

information to be collected?

4. How can the burden of the

information collection be minimized,

including the use of automated

collection techniques?

Send comments regarding these

burden estimates or any other aspect of

this collection of information, including

suggestions for reducing the burden, to

the Information and Records

Management Branch (T–6 F33), U.S.

Nuclear Regulatory Commission,

Washington, DC 20555–0001, and to the

Desk Officer, Office of Information and

Regulatory Affairs, NEOB–10202,

(3150–0146), Office of Management and

Budget, Washington, DC 20503.

The NRC may not conduct or sponsor,

and a person is not required to respond

to, a collection of information unless it

displays a currently valid OMB control

number.

Regulatory Analysis

The Commission has prepared a draft

regulatory analysis on this proposed

rule. The analysis examines the benefits,

cost savings, and costs of the

alternatives considered by the

Commission. The draft analysis is

available for inspection in the NRC

Public Document Room, 2120 L Street

NW. (Lower Level), Washington, DC.

Single copies may be obtained from

Loren L. Bush, Jr., Office of Nuclear

Reactor Regulation, U.S. Nuclear

Regulatory Commission, Washington,

DC, telephone (301) 415–2944.

Regulatory Flexibility Act Certification

In accordance with the Regulatory

Flexibility Act of 1980, (5 U.S.C.

605(b)), the Commission certifies that

this rule will not have a significant

economic impact on a substantial

number of small entities. This proposed

rule affects only the licensing and

operation of nuclear power plants and

activities associated with the possession

or transportation of Category I material.

The companies that own these plants do

not fall within the scope of the

definition of ‘‘small entities’’ set forth in

the Regulatory Flexibility Act or the size

standards adopted by the NRC on April

11, 1995 (60 FR 18344—10 CFR 2.810).

Backfit Analysis

This proposed rule would modify a

prior Commission position by adding

new requirements and reducing other

requirements. The modifications are

intended to improve the effectiveness of

the rule in the light of demonstrated

program performance and lessons

learned since the implementation of the

rule and to enhance overall program

integrity. Some of the modifications

would be made to make the rule

consistent with modifications to the

national standards on drug testing

promulgated by the Department of

Health and Human Services. Other

modifications are intended to prevent

subversion of the testing process

(examples include: limiting the time

between notification and testing, using

a narrower temperature range to make it

more difficult to submit a surrogate

sample), further ensure the accuracy

and integrity of testing (examples

include: determining specimen quality,

using a narrower temperature range, and

requiring timely shipping and testing of

specimens to prevent degradation of

specimens), clarify actions for removal

and return to service, incorporate

advances in technology (example:

measures to eliminate ‘‘false positives’’

from legitimate use of amphetamines),

and protect individual rights.

The proposed changes are, for the

most part, minor program adjustments

or clarifications and do not alter the

Commission’s original intent.

Furthermore, the modifications would

better achieve the level of assurance in

the accuracy of results and the integrity

of the testing process which was

originally intended. The NRC believes

that some of the changes are needed to

minimize the vulnerabilities that are

being exploited by substance abusers.

To facilitate public consideration of

these proposed changes, the

Commission has placed the proposed

rule changes into the three groups

appearing below. The first group

consists of those changes intended to

conform the rule to the HHS Mandatory

Guidelines that have been modified

since the rule was last revised.

Subgroup IA lists those changes

intended to make the NRC rule

compatible with the HHS Guidelines as

revised. Because the Commission

continues to desire to permit more

stringent programs than set forth in the

HHS Guidelines, it was necessary to

adjust some of the new HHS

requirements to meet the needs of the

nuclear power industry. These are listed

in subgroup IB.
Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules 21129

The second group consists of those

rule changes that would reduce

licensees’ regulatory burden. Subgroup

IIA lists those changes in this category

for which the Commission was able to

calculate specific monetary savings to

licensees. Some of the proposed changes

in the second group would provide

licensees with FFD program

administrative flexibility that would

provide some indeterminate reduction

in burden. These changes are found in

subgroup IIB.

Group III contains several proposed

revisions that the Commission believes

to be worthwhile and necessary to better

accomplish the FFD rule’s objectives.

Subgroup IIIA consists of those

proposed revisions that are particularly

important to achieving the rule’s

objectives. These include revisions

designed to reduce the incidence of

subversion of drug and alcohol testing

and to enhance the rule’s protection of

the rights of workers subject to the rule.

The proposed changes appearing in

subgroup IIIB would serve to clarify the

rule’s existing requirements, reduce

ambiguities that have often resulted in

interpretative debates, and make other

administrative changes. Some of the

Group III changes, such as establishing

a more restrictive temperature range,

would result in a departure from the

HHS guidelines.

Whether the proposed changes would,

considered as a whole or individually,

provide a substantial increase in overall

protection of the public health and

safety is a significant question. NRC

staff is of the preliminary view that

these changes, although desirable,

would not provide a substantial

increase. Public comment is specifically

requested on this question of

substantiality.

If the Commission were unable to

conclude at the final rulemaking stage

that these changes would provide a

substantial increase in overall

protection, the further question arises

whether the rule should nevertheless go

forward. One approach to continuation

of the rulemaking would be to view the

rule as a whole and to conclude, if

warranted, that the rule’s cumulative

effect is to ease licensee burdens or

leave them essentially the same, rather

than to increase them. This would be

consistent with an interpretation that

the backfit rule does not apply to

relaxations of requirements. However,

the mandatory nature of the proposed

rule, and effects on interested persons

other than licensees, could present

complicating factors. Alternatively, the

question is presented whether those

subject to the rule would decide not to

object to the new requirements in view

of a perceived overall benefit and, if so,

whether non-objection could be grounds

for not applying the backfit rule. The

basis here would be that the backfit rule

was solely directed at controlling

objectionable impositions of additional

requirements. Public comment on these

considerations is specifically invited.

LIST OF PROPOSED CHANGES TO 10 CFR

PART 26

Group I: Adoption of National

Standards

A. Changes To Ensure Compatibility

With the HHS Guidelines as Revised in

June 1994

§ 26.24

(f) MRO to report FFD policy violation

in writing.

(g) Ensure all collected specimens are

tested and results are reported.

Section 1.2 of Appendix A

• Delete definition of permanent

record book

Section 2.4 of Appendix A

(d) Courier signature not needed on

chain-of-custody documents.

(g)(4) Eliminate requirement that

tester request list of medications prior to

specimen collection.

(g)(9)+(24) Eliminate the requirement

for a permanent record book.

(g)(10)+(15)+(23)+(24) Allow

accompaniment or observation by

person of same gender, other than a

collection site person.

(g)(11) Clarify fluid intake to assist in

providing specimen.

(g)(13) Specify the temperature range

for an acceptable urine specimen in

whole numbers.

(i) Clarify requirements concerning

use of second, tamper-evident shipping

container.

Section 2.6 of Appendix A

• Assure training of licensee testing

facility managers includes maintenance

of chain of custody.

Section 2.7 of Appendix A

(f) Lower the cutoff level for

marijuana screening tests from 100 ng/

ml to 50 ng/ml.

(g) Modify the criteria for determining

that a specimen is positive for

amphetamines.

(g) Require testing for d and l isomers

of amphetamines.

(h) Eliminate batch reporting of

results.

(p) Laboratory shall not have a

conflict of interest with licensee’s MRO.

Section 2.8 of Appendix A

(e) Require blind quality control

materials meet standards for

preparation, certification, and stability.

Section 2.9 of Appendix A

(b) MROs shall not have a conflict of

interest with certified laboratories.

Section 4.1 of Appendix A

(b) Note that licensees need to take

appropriate measures when testing

outside HHS certification process.

B. Changes To Conform HHS Guidelines

Revisions to the Framework of the

Original FFD Rule

§ 26.24

(d)(1)+(g) Require licensees to ensure

that all collected specimens are tested

and results reported.

Section 2.4 of Appendix A

(g)(11) Reduce required minimum

quantity of each urine specimen from 60

ml to at least 30 ml (Where licensee

chooses to test on site, split specimens,

or to test for additional drugs, more than

30 ml will be necessary).

Section 2.7 of Appendix A

(e) Validity of specimens, i.e., tests for

adulteration and dilution at HHS

laboratory.

(f) Permit multiple immunoassay

(screening) tests for the same drug or

drug class.

(k) Clarifications to split specimen

collection and dispatch procedures and

laboratory selection.

(k) Minimum time for requests by

individuals to have split specimen

tested at another HHS laboratory.

Section 2.8 of Appendix A

(e) Reduce the maximum number and

percentage of blind performance

specimens to be submitted per quarter

but require a minimum.

Section 2.9 of Appendix A

(e) Minimum time for request by

individual for reanalysis of original

specimen added.

Group II: Reduction in Burden

A. Changes With Quantitative Monetary

Benefits

§ 26.2

(f) Eliminate duplicate testing under

multiple programs.

§ 26.20

(f) Credit for unescorted access status

granted by another licensee.
21130 Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules

§ 26.21

(b) Refresher training intervals

extended from 1 to 2 years.

(b) Acceptance of generic portions of

training provided by another licensee.

§ 26.22

(c) Acceptance of generic portions of

training provided by another licensee.

§ 26.24

(a)(1) Flexibility in pre-access testing

—Tests within past 60 days may be

considered pre-access tests if they

meet the standards of Part 26

—Access may be granted pending test

results for individuals covered by an

acceptable FFD program for 2

consecutive weeks in the past 6

months

—No pre-access test for those

transferring from another program

who have been covered by an FFD

program meeting the requirements of

Part 26 for 30 of the past 60 days.

(a)(2) Persons off site and unavailable

when chosen for random testing may be

tested when next on site.

(a)(3) People tested for-cause for

alcohol can return to duty while

awaiting urinalysis results.

(a)(5) Clarify existing testing

requirements for persons unavailable for

testing for short periods and insure

consistency with the access

authorization program.

(e) Limit time between notification

and specimen collection.

§ 26.27

(a) Fitness history need not be

obtained for those covered by other

programs or absent for 30 days or less.

§ 26.71

(d) Reduce frequency of program

performance reports.

§ 26.80

(a) Change to performance based audit

as the basis for reducing required

frequency.

Section 2.2 of Appendix A

(a) Permit prompt destruction of

chain-of-custody forms showing

negative test results.

Section 2.3 of Appendix A

• Extend reinvestigation interval for

FFD program personnel from 3 to 5

years.

Section 2.4 of Appendix A

(g)(18) Eliminate second breath

specimen when test shows no alcohol.

Section 2.7 of Appendix A

(e) Test questionable specimens to

level of detection.

(h) Permit MRO staff to perform

certain support functions.

(n) Eliminate need to audit areas

covered by HHS inspections.

B. Changes That Provide Greater

Flexibility and Indeterminate Monetary

Benefits

§ 26.2

(e) Reduce requirements during

decommissioning.

§ 26.22

(c) Refresher training intervals may be

extended from 12 to 36 months if

written exam is given every 12 months.

§ 26.24

(a)(3) Provide flexibility in timeliness

of for-cause test.

(f) MRO to complete review as soon

as practicable and inform management

if determination of test result is delayed

more than 14 days after collection

instead of completing review and

notifying within 10 days after screening

test.

(i) Flexibility for unusual medical

conditions.

§ 26.27

(a) Certain aspects of fitness history to

be limited to 5 years.

(a) Power reactor licensees usually

need not obtain statements responding

to activities related to possession or

transport of Category I nuclear material.

(c) Allow records of FFD violations to

be discarded after 5 years.

§ 26.29

(b) Permit provision of personal

information for judicial or

administrative proceedings initiated by

the subject individual.

(b) Permit provision of personal

information to contractors and vendors.

Section 2.2 of Appendix A

(a) Reduce time for retention of chainof-custody forms showing violations.

Section 2.4 of Appendix A

(g)(13) Allow licensees to set

temperature range within rule limits.

(g)(24) MRO or other designated

medical person can authorize an

observed collection.

(j) Flexibility on licensee internal

reporting and actions when individual

fails to cooperate.

Section 2.7 of Appendix A

(c) Flexibility in means of keeping

specimens chilled.

(f)+(g) When licensee uses more

stringent cutoff levels, tests at level set

by the rule can be calculated and need

not be conducted.

(h) Reduce time for laboratories to

report results.

(n) Flexibility provided if lab loses

certification.

(p) Flexibility to use old or new

NHTSA standards for breath analysis

equipment.

Section 2.8 of Appendix A

(f) Allow disposal of records of

investigative findings after 3 years.

Section 2.9 of Appendix A

(d) Delete requirement for MRO

determination of clinical evidence of

legal drugs.

(i) Allow disposal of records of

negative test results, based on scientific

insufficiency, after 3 years.

Group III: Other Worthwhile Changes

A. Improvements Based on Experiences

That the NRC Believes Are Needed and

Proposes To Adopt

§ 26.24

(a)(5) Require return-to-duty testing

after extended absences or denial of

access.

(d)(1) Require onsite testers to

determine validity of specimens on site.

(h) Require back calculations for

BACs between 0.02 and 0.04.

§ 26.27

(b)(3)+(4) Minimum sanctions for

positive test for alcohol or the use of

alcohol within the protected area.

§ 26.28

• Assure that appeal rights cover all

types of violations, including confirmed

positive test results from applicants for

unescorted access and determinations of

subversion.

• Assure that relevant records are

corrected if appeal is successful.

§ 26.29

(c) Assure provision of copies of

records to individuals upon written

request.

Section 2.4 of Appendix A

(g)(13)+(15) More restrictive

temperature range for an acceptable

urine specimen.

(i) Laboratory must receive specimens

within 48 hours of shipment.

Section 2.7 of Appendix A

(d) Specimens questionable for

adulteration or dilution at licensees’

testing facilities must be shipped to

HHS laboratory for testing.

(e) Require onsite testers to determine

validity of specimens on site.
Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules 21131

B. Clarifications to Existing

Requirements, Changes To Reduce

Interpretive Debates, and

Administrative Changes Which Are Also

Proposed

§ 26.2

(a) FFD program personnel to be

covered by FFD rule.

§ 26.3

• To support other rule changes,

revise existing definitions, create new

definitions, and relocate some

definitions from Section 1.2 of

Appendix A.

§ 26.7

• New section ensures

communications are sent to Document

Control Desk.

§ 26.8

(c) Section regarding burden estimates

deleted.

§ 26.20

• Minor clarifying and conforming

edits (Introduction, (c), (d), (e)(2)).

(a) Offsite involvement with drugs,

subversion of the testing process, and

refusals to test added to policy

statement.

(a) Clear and concise policy statement

must be readily available.

(a) Policy must address impairment

from legal drug use.

(d)(3)+(4) Policy must specify actions

to be taken for subversion and refusal to

provide a specimen.

(e)(1) Declaration of fitness to perform

tasks assigned when contacted for callin.

(f) Statement regarding Commission’s

right to review licensee policy is

deleted.

§ 26.21

(a) Minor administrative and

clarifying edits.

§ 26.22

(c) Supervisory training for licensee

employees must be completed as soon

as feasible following assignment to

supervisory duty.

(c) Supervisory training for contractor

employees must be completed no later

than 10 days following assignment to

supervisory duty.

§ 26.23

(a) Clarify that persons with a known

(to the contractor or vendor) history of

substance abuse must not receive

assignments to the protected area

without the knowledge and consent of

the licensee.

§ 26.24

(a)(1) Specify that all testing prior to

granting unescorted access is to be

called pre-access testing.

(a)(1) Clarify that negative pre-access

test result must be obtained prior to

access.

(a)(2) Random testing must be

conducted on weekends, backshifts, and

holidays.

(a)(2) Individuals selected for random

testing during an absence of 60 days or

more to be tested only once to meet both

random and return-to-duty testing

requirements (see § 26.24 (a) (5)); tests to

be reported as random.

(a)(3) Clarify conditions that initiate

for-cause test.

(a)(3) Ensure removal of unfit persons

and determination of fitness prior to

return to duty.

(a)(4) Relocate follow-up testing

requirements from § 26.27(b)(4/5) and

clarify testing is to be unpredictable and

tailored to medical history.

(a)(4)+(c)+(d)+(f)+(g)+(h) Minor

clarifying edits.

(h) Clarify that blood testing for

alcohol is for purposes of appeal.

(h) Clarify that any detectable

quantity of alcohol in a blood specimen

may be considered to determine FFD

violation.

§ 26.25

• Clarify that EAPs must be designed

to achieve early intervention and must

assure confidentiality.

§ 26.27

(a)+(b) Clarifying and conforming

edits.

(b)(1)+(3)+(5) Clarification of

requirements with respect to access

denial, removal, and return to service.

(b)(2) Conforming change regarding

the threshold for alcohol policy

violation.

(b)(3) People suspended must still be

covered by behavioral observation,

chemical testing, and sanctions for

violations.

(c) Clarify that acts of subversion must

be violations of policy and result in

denial of unescorted access for 3 years

and that the specific cause for removal

must be provided in response to an

inquiry.

(d) Clarify licensee handling of NRC

contractors believed to be unfit.

§ 26.28

• Clarify that the appeals process

must be objective and conducted by

persons not associated with the FFD

program.

• Clarify that an individual may

submit additional relevant information

§ 26.29

(b)+(c) Clarifying and conforming

edits.

§ 26.70

(a) Clarifies the records that NRC may

inspect.

§ 26.71

(b)+(c) Conforming edit.

(d) Include number of subversion

attempts by type in program

performance reports.

§ 26.73

(a) Conforming changes.

(a) Provides additional examples of

significant FFD events.

§ 26.80

(c) Conforming edit.

Section 1.1 of Appendix A

• Minor clarifying edits.

Section 1.2 of Appendix A

• Delete terms defined elsewhere in

Part 26 or relocated to § 26.3.

• Add definition of limit of detection

(LOD).

Section 2.1 of Appendix A

(a) Conforming editorial changes.

(b) Conforming editorial changes.

(e) Minor edit.

Section 2.2 of Appendix A

(a)+(d) Minor and conforming edits.

Section 2.3 of Appendix A

• Minor clarifying edits.

• Fitness-for-duty program personnel

tested by independent personnel to the

extent practicable.

Section 2.4 of Appendix A

(f) Minor clarifying changes.

(f) Current or previous specimen that

fails to meet normal standards

constitutes a reason to require observed

testing.

(g) Minor clarifying changes.

(g)(14)+ (15)+ (18)+ (19)+ (20)+ (23)+

(24)+ (27) Conforming and clarifying

changes.

(g)(23) Require secure sealing of

specimen bottle.

(h)+(i) Minor clarification of sealing

and labeling requirements.

(i) Continue to require specimens to

be shipped to HHS laboratory or cooled

within 6 hours of collection as

previously required by § 2.7 (c).

(i)+(j) Conforming changes.

Section 2.5 of Appendix A

• Minor clarifying edits.

Section 2.7 of Appendix A

(b)+(d)+(f)+(g)+(h)+(i)+(k)+(l)+(m)

Minor clarifying edits.
21132 Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules

(c) Require chilling or testing within

one day of arrival at HHS laboratory.

(d) MRO to report adulteration or

dilution to management immediately.

(f)+(g) Standards for BAC established.

(h) Evidence of subversion must be

reported by HHS laboratory.

(h) Laboratory retention of original

chain-of-custody form.

(i) Specimens associated with

subversion to be placed in long-term

storage.

(j) Retesting of adulterated or diluted

specimens need only confirm specimen

not valid.

(m) HHS laboratories must have blood

analysis capabilities.

(n) Specify that licensee contracts

with HHS laboratories will assure that

copies of records are available to

licensees and NRC inspectors.

(p) Calibration standards (for

calibrating equipment used to test for

alcohol and screen for drugs) must be

current and valid.

(p) Two-year retention period for

laboratory procedure manuals after end

of contract with licensee.

(p) Licensee to retain latest testing

procedure manual until it is no longer

performing onsite testing.

Section 2.8 of Appendix A

(a)+(b)+(c)+(e)+(f) Minor clarifying

and conforming edits.

(b) Laboratory results on blind

performance specimens must be

evaluated and appropriate corrective

actions taken.

(e) Change the proportion of blank

and positive blind performance test

specimens.

(e) Assure regularity of submission of

blind test specimens.

(e) Adulterate or dilute and spike

some blind performance specimens.

(e) Specify that initial 90-day period

for blind performance testing rate

applies to all new contracts with HHS

laboratories.

(f) Investigation of testing process

errors and inclusion of report of action

taken.

(f) All false positive errors must be

reported to NRC.

Section 2.9 of Appendix A

(a) Minor conforming edits.

(b)+(c)+(d)+(e)+(f) Clarifying and

conforming changes to MRO duties for

reporting and review of results.

(d) Clarification of clinical evidence

of abuse.

(f)+(g) Medical determination of

fitness to perform duties defined.

(h) Conforming language for

extrapolation of BAC results between

0.02 and 0.04

(i) Minor clarifying edits.

Section 3.2 of Appendix A

• Section deleted and incorporated

into § 26.29(c).

Section 4.1 of Appendix A

(a) SAMHSA replaces NIDA and

change of room number.

List of Subjects in 10 CFR Part 26

Alcohol abuse, Alcohol testing,

Appeals, Chemical testing, Drug abuse,

Drug testing, Employee assistance

programs, Fitness for duty, Management

actions, Nuclear power reactors,

Protection of information, Reporting and

recordkeeping requirements, Sanctions.

For the reasons set out in the

preamble and under the authority of the

Atomic Energy Act of 1954, as amended,

the Energy Reorganization Act of 1974,

as amended, and 5 U.S.C. 553, the NRC

is proposing to adopt the following

amendments to 10 CFR Part 26.

PART 26—[AMENDED]

1. The authority citation for part 26 is

revised to read as follows:

Authority: Secs. 53, 81, 103, 104, 107, 161,

68 Stat. 930, 935, 936, 937, 939, 948, as

amended, (42 U.S.C. 2073, 2111, 2112, 2133,

2134, 2137, 2201); secs. 201, 202, 206, 88

Stat. 1242, 1244, 1246, as amended (42 U.S.C.

5841, 5842, 5846).

2. In § 26.2, paragraphs (a) and (d) are

revised, and new paragraphs (e), and (f)

are added to read as follows:

§ 26.2 Scope.

(a) The regulations in this part apply

to licensees authorized to operate a

nuclear power reactor, to possess or use

formula quantities of SSNM, or to

transport formula quantities of SSNM.

Each licensee shall implement a fitnessfor-duty program which complies with

this part. The provisions of the fitnessfor-duty program must apply to:

(1) All persons granted unescorted

access to nuclear power plant protected

areas;

(2) Licensee, vendor, or contractor

personnel required to physically report

to a licensee’s Technical Support Center

(TSC) or Emergency Operations Facility

(EOF) in accordance with licensee

emergency plans and procedures;

(3) SSNM licensee and transporter

personnel who:

(i) Are granted unescorted access to

Category IA Material;

(ii) Create or have access to

procedures or records for safeguarding

SSNM; and

(iii) Make measurements of Category

IA Material;

(iv) Transport or escort Category IA

Material; or

(v) Guard Category IA Material; and

(4) FFD program personnel who:

(i) Can link test results with the

person who was tested;

(ii) Make removal and return-to-work

recommendations or decisions;

(iii) Are involved in the selection and

notification of employees for testing and

in the collection and on-site testing of

specimens.

* * * * *

(d) The regulations in this part apply

to the Corporation required to obtain a

certificate of compliance or an approved

compliance plan under part 76 of this

chapter only if the Corporation elects to

engage in activities involving formula

quantities of strategic special nuclear

material. When applicable, the

requirements apply only to the

Corporation and personnel carrying out

the activities specified in § 26.2(a)(3).

(e) For facilities in the process of

being decommissioned, the scope of a

fitness-for-duty program may be

reduced to persons and specified areas

as deemed appropriate by the NRC to

protect public health and safety.

(f) Persons performing activities under

this part who are covered by a program

regulated by another Federal agency or

State that meets the general performance

objectives of this part need only be

covered by those aspects of a licensee’s

fitness-for-duty program not included in

the Federal agency or state program.

3. Section 26.3 is amended by

removing the definitions for follow-up

testing, random test, and suitable

inquiry, revising aliquot, confirmatory

test, and confirmatory positive test, and

adding in alphabetical order the

following definitions, abuse of legal

drugs, behavioral observation, blood

alcohol concentration (BAC), HHScertified laboratory, laboratoryconfirmed positive, licensee’s testing

facility, medical determination of

fitness, screening test, substance abuse,

subversion and subvert the testing

process, supervisor, and unconfirmed

positive test result.

§ 26.3 Definitions.

Abuse of legal drugs means the use of

a legal drug (e.g., alcohol, prescription,

over-the-counter drugs) in a manner that

constitutes a health or safety hazard to

the individual or to others, including

on-the-job impairment. Legal or

employment actions against an

individual for use of legal drugs

constitute evidence of the existence of a

health or safety hazard.

Aliquot means a portion of a

specimen used for testing. It is taken as

a sample representing the whole

specimen.

Behavioral observation means

observation by supervisors in the course
Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules 21133

of their contacts with other personnel to

detect degradations in performance,

signs of impairment, or changes in

behavior which may indicate the need

to evaluate an individual’s fitness for

duty.

Blood Alcohol Concentration (BAC)

means a measure of the mass of alcohol

in a volume of blood.

* * * * *

Confirmatory test means a second

analytical procedure to identify the

presence of a specific drug or drug

metabolite which is independent of the

screening test and which uses a

different technique and chemical

principle from that of the screening test

in order to ensure reliability and

accuracy. (At this time, gas

chromatography/mass spectrometry

(GC/MS) is the only authorized

confirmation method for cocaine,

marijuana, opiates, amphetamines, and

phencyclidine.) For determining blood

alcohol levels, a ‘‘confirmatory test’’

means a second test using another

breath alcohol analysis device.

Additional information may be obtained

by gas chromatography analysis of

blood.

Confirmed positive test means a

laboratory confirmed positive test result

that has been verified as a violation of

FFD policy by the Medical Review

Officer (MRO) after evaluation. A

‘‘confirmed positive test’’ for alcohol is

obtained as a result of a confirmation of

blood alcohol levels of 0.04 percent or

higher with a second breath analysis

without MRO evaluation or as the result

of an extrapolation back in time (back

calculation) performed by the MRO.

* * * * *

HHS-certified laboratory means a

urine testing laboratory that maintains

certification to perform drug testing

under the Department of Health and

Human Services (HHS) ‘‘Mandatory

Guidelines for Federal Workplace Drug

Testing Programs.’’

* * * * *

Laboratory confirmed positive means

the result of a confirmatory test that has

established the presence of drugs, or

drug metabolites, at a sufficient level to

be an indication of prohibited drug use.

Licensee’s testing facility means a

drug testing facility operated by the

licensee or one of its vendors or

contractors to perform on site the initial

testing of urine specimens.

Medical determination of fitness

means the process whereby a licensed

physician, who may be the MRO,

qualified to make such determination

examines and interviews an individual

and reviews any appropriate and

relevant medical records, in accordance

with standard clinical procedures, in

order to determine whether there are

indications that the individual may be

in violation of the licensee’s FFD policy

or is otherwise unable to safely and

competently perform duties. The

qualifications for making the

determination are related to the fitness

issues presented by the patient.

* * * * *

Screening test means an immunoassay

screen for drugs or drug metabolites to

eliminate ‘‘negative’’ urine specimens

from further consideration, or the first

breathalyzer test for alcohol. Initial

screening may be performed at the

licensee’s testing facility; a second

screen and confirmation testing for

drugs or drug metabolites must be

conducted by a HHS-certified

laboratory.

Substance abuse means the use, sale,

or possession of illegal drugs or the

abuse of legal drugs (e.g., alcohol,

prescription drugs, and over-the-counter

drugs) or other substances.

Subversion and Subvert the testing

process mean an act intended to avoid

being tested or to bring about an

inaccurate drug or alcohol test result for

oneself or others. Acts of subversion can

occur at any stage of the testing program

including selection and notification of

individuals for testing, specimen

collection, specimen analysis, and

testing result reporting processes and

can include providing a surrogate urine

specimen, diluting a specimen, (in vivo

or in vitro) and adding an adulterant to

a specimen.

* * * * *

Supervisor means any person who has

the immediate oversight responsibilities

to direct activities of any other person

or persons within the protected area or

has ongoing responsibility for the

supervision of an individual with

unescorted access status while that

individual is not in the protected area.

* * * * *

Unconfirmed positive test result

means the result of a screening test for

drugs and drug metabolites that

indicates the presence of some drug or

drug metabolite and that has the

potential to be confirmed through GC/

MS testing by an HHS-certified

laboratory as a laboratory confirmed

positive test result, or the result of a

screening test for alcohol indicating a

blood alcohol content of 0.02 percent or

greater.

* * * * *

4. Section 26.7 is added to read as

follows:

§ 26.7 Communications.

Except where otherwise specified in

this part, all communications and

reports concerning the regulations in

this part must be addressed to the NRC

Document Control Desk, U.S. Nuclear

Regulatory Commission, Washington,

DC 20555–0001. Copies of all

communications must be sent to the

appropriate regional office and resident

inspector. Communications and reports

may be delivered in person at the

Commission’s offices at 2120 L Street,

NW., Washington, DC, or at 11555

Rockville Pike, One White Flint North,

Rockville, Maryland.

§ 26.8 [Amended].

5. In § 26.8, paragraph (c) is removed.

6. In § 26.20, the introductory text and

paragraphs (a), (c), (d), (e), introductory

text, (e)(1), (e)(2), and (f) are revised to

read as follows:

§ 26.20 Written policy and procedures.

Each licensee subject to this part shall

establish and implement written

policies and procedures designed to

meet the general performance objectives

and specific requirements of this part.

Each licensee shall retain a copy of its

latest written policy and procedures as

a record until the Commission

terminates the licenses for which for

which the policy and procedures were

developed. If any portion of the policies

and procedures are superseded, the

superseded material must be retained

for at least three years. As a minimum,

written policies and procedures must

address fitness for duty through the

following:

(a) An overall description of licensee

policy on fitness for duty. The policy

must address use of and offsite

involvement with illegal drugs, abuse of

legal drugs (e.g., alcohol, prescription

and over-the-counter drugs), subversion

of the testing process, and refusals to

provide a specimen for testing. A clear

and concise written statement of this

policy must be prepared and be in

sufficient detail to provide affected

individuals with informtion on what is

expected of them, and what

consequences may result from lack of

adherence to the policy. This statement

must be readily available to all persons

subject to the policy.

(1) As a minimum, the written policy

must prohibit the consumption of

alcohol—

(i) Within an abstinence period of at

least 5 hours preceding any scheduled

working tour; and

(ii) During the period of any working

tour.

(2) Licensee policy should also

address other factors that could affect
21134 Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules

fitness for duty such as mental stress,

fatigue, illness, and the use of

prescription and over-the-counter

medications that could cause

impairment.

* * * * *

(c) Procedures to be utilized in testing

for drugs and alcohol, including

procedures for protecting individuals

providing a specimen and the integrity

of the specimen, and the quality

controls used to ensure the test results

are valid and attributable to the correct

individual.

(d) A description of immediate and

follow-on actions which will be taken,

and the procedures to be utilized, in

those cases where persons who are

employed by licensees, vendors, or

contractors, and are assigned to duties

within the scope of this part, are

determined to have—

(1) Been involved in the use, sale, or

possession of illegal drugs;

(2) Consumed alcohol during the

mandatory pre-work abstinence period,

while on duty, or to excess before

reporting to duty as demonstrated with

a test that can be used to determine

blood alcohol concentration;

(3) Attempted to subvert the testing

process by adulterating or diluting

specimens (in vivo or in vitro),

substituting specimens, or by any other

means; or

(4) Refused to provide a specimen for

analysis.

(e) A procedure that will ensure that

persons called in to perform an

unscheduled working tour are fit to

perform the task assigned. As a

minimum, this procedure must—

(1) Require a statement to be made by

a called-in person when contacted as to

whether he or she considers himself or

herself fit to perform the task assigned

and whether he or she has consumed

alcohol within the length of time stated

in the pre-duty abstinence policy;

(2) If alcohol has been consumed

within this period, require a

determination of fitness for duty by

breath analysis or other means

(collection of urine under § 26.24(a)(3)

is not required); and

* * * * *

(f) Licensees seeking to grant

unescorted access pursuant to 10 CFR

73.56 to personnel covered by another

licensee’s FFD program that complies

with this part may credit that licensee’s

program through verification that the

individual is currently and will

continue to be subject to the random

testing and behavioral observation

programs of either his or her employer

or those of the host licensee.

7. In § 26.21, the introductory text of

paragraph (a) and paragraphs (a)(2) and

(b) are revised to read as follows:

§ 26.21 Policy communications and

awareness training.

(a) Persons assigned to activities

within the scope of this part must be

provided with appropriate training to

ensure they understand—

* * * * *

(2) The personal and public health

and safety hazards associated with the

use of illegal drugs and the abuse of

legal drugs including alcohol;

* * * * *

(b) Initial training in the five topics in

paragraph (a) of this section must be

completed before assignment to

activities within the scope of this part.

Refresher training in those five topics

must be completed on a nominal 24

month frequency or more frequently

where the need is indicated. A record of

the training must be retained for a

period of at least three years. Licensees

may accept training of individuals who

have been subject to another Part 26

program and who have had initial or

refresher training within the 24 months

before assignment provided that training

by the accepting licensees in the sitespecific topics covered by paragraphs (a)

(1), (4), and (5) of this section is

completed before the granting of

unescorted access to the protected area.

8. In § 26.22, the introductory text of

paragraph (a) and paragraphs (a)(4) and

(c) are revised to read as follows:

§ 26.22 Training of supervisors and

escorts.

(a) Managers and supervisors of

activities within the scope of this part

must be provided appropriate training

to ensure they understand—

* * * * *

(4) Behavioral observation techniques

for detecting degradation in

performance, impairment, or changes in

an individual’s behavior; and

* * * * *

(c) Initial training for escorts and

licensee employees’ supervisors must be

completed before assignment of duties

within the scope of this part, except that

after an initial supervisory assignment,

the initial training must be completed as

soon as feasible but no later than 3

months following the assignment of

supervisory duties. Initial training for

supervisors of contractor personnel

must be completed before assignment of

the supervised contractor personnel to

duties within the scope of this part or

within 10 days after initial supervisory

assignment, whichever is later.

Refresher training must be completed on

a nominal 12-month frequency, or more

frequently where the need is indicated.

A written examination on the training

material given on a nominal 12-month

frequency may be used in lieu of

refresher training. The written

examination must require a

demonstration of adequate knowledge of

the areas covered in paragraph (a) of this

section. Refresher training must be

completed on a nominal 36-month

frequency even if examinations are used

to fulfill this requirement during the

interim period. A record of the training

or examination in lieu of training must

be retained for a period of at least three

years. Licensees may accept training of

individuals who have been subject to a

part 26 program and who have had

initial or refresher training within the 12

months before assignment provided that

training by the accepting licensee in the

topics covered by paragraphs (a)(1), (2),

and (5) of this section is completed

before granting unescorted access to the

protected area.

9. In § 26.23, the introductory text of

paragraph (a) and paragraph (a)(2) are

revised to read as follows:

§ 26.23 Contractors and vendors.

(a) All contractor and vendor

personnel performing activities within

the scope of this part for a licensee must

be subject to either the licensee’s

program relating to fitness for duty, or

to a program, formally reviewed and

approved by the licensee, which meets

the requirements of this part. Written

agreements between licensees and

contractors or vendors for activities

within the scope of this part must be

retained for the life of the contract and

will clearly show that—

* * * * *

(2) Personnel with a known history of

substance abuse or having been denied

access or removed from activities within

the scope of this part at any nuclear

power plant for violations of a fitnessfor-duty policy will not be assigned to

work within the scope of this part

without the knowledge and consent of

the licensee.

* * * * *

10. In § 26.24, paragraphs (a), (c),

(d)(1), the introductory text of (d)(2),

(d)(2)(i) and (d)(2)(iv) are revised,

paragraphs (e), (f), and (g) are

redesignated as paragraphs (f), (g), and

(h) and revised, and new paragraphs (e)

and (i) are added to read as follows:

§ 26.24 Chemical testing.

(a) To provide a means to deter and

detect substance abuse, the licensee

shall implement the following chemical

testing programs for persons subject to

this part:
Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules 21135

(1)(i) Preaccess testing for drugs and

alcohol must be conducted within 60

days before the initial granting of

unescorted access to protected areas or

assignment to activities within the

scope of this part unless the individual:

(A) Has been covered by a program

meeting the requirements of this part for

at least 30 days during the 60 days

immediately previous to the granting of

unescorted access; and

(B) Has no history of substance abuse.

(ii) Any negative drug and alcohol test

meeting the standards of this part and

performed within 60 days before

granting unescorted access may serve as

the preaccess test. A negative test result

must be obtained before the granting of

unescorted access unless the individual

has no history indicating the use of

illegal drugs or the abuse of legal drugs

(e.g., alcohol, prescription, and over-thecounter drugs) and has either had a

negative test result on a test meeting the

standards of this part performed within

six months before granting unescorted

access or has been covered by a program

meeting the standards of this part for

two consecutive weeks during that

period.

(2) Unannounced drug and alcohol

tests must be imposed in a statistically

random and unpredictable manner so

that all persons in the population

subject to testing have an approximately

equal probability of being selected and

tested. Random testing must include

testing during all types of work periods,

including weekends, backshifts, and

holidays. The tests must be

administered so that a person

completing a test is immediately eligible

for another unannounced test. At a

minimum, tests must be administered

on a nominal weekly frequency and at

various times during the day.

Reasonable efforts must be made to test

persons selected for random testing.

Persons off site when selected for

testing, and not reasonably available for

testing in a timely manner, must be

tested upon returning to the site. For

persons off site for more than sixty days,

such tests will fulfill the requirement for

return-to-duty testing and should be

reported to the NRC as random tests.

Random testing must be conducted at an

annual rate equal to at least 50 percent

of the workforce.

(3)(i) For-cause drug and alcohol

testing must be conducted:

(A) Following any observed behavior

or physical condition that creates a

reasonable suspicion of possible

substance abuse including attempts to

subvert the testing process;

(B) After accidents involving a failure

in individual performance resulting in

personal injury, in a radiation exposure

or release of radioactivity in excess of

regulatory limits, or actual or potential

substantial degradations of the level of

safety of the plant if there is reasonable

suspicion that the individual’s

performance contributed to the event;

and

(C) after receiving credible

information that an individual is

abusing drugs or alcohol.

(ii) The individual’s unescorted

access status must be suspended until

pronounced fit for duty based on a

medical determination of fitness. If the

test is based on suspected use of alcohol

and the breath analysis is negative, the

individual, if determined fit for duty by

a medical determination of fitness, may

be returned to duty pending results of

urinalysis for drugs. For-cause drug and

alcohol testing must be conducted as

soon as practicable, but within no more

than 2 hours for an alcohol test and 8

hours for specimen collection for a drug

test.

(4) Follow-up testing must be

conducted on an unannounced and

unpredictable basis to verify continued

abstention from the use of substances as

covered under this part. An individual:

(i) Whose unescorted access is

reinstated after a suspension under

§ 26.27(b)(3); or

(ii) Is granted unescorted access after

removal under § 26.27(b) (3) or (4) must

be subject to follow-up testing that is

tailored to the individual’s medical

history but not less frequently than once

every month for four months and at

least once every three months for the

next two years and eight months after

unescorted access is reinstated.

(5) Return-to-duty testing must be

conducted when a person seeks to

regain unescorted access to protected

areas of the site in question after an

absence from the possibility of being

tested under that site licensee’s program

for more than 60 days or when a person

seeks to regain unescorted access after

having been denied access under the

provisions of § 26.27(b). Any negative

drug and alcohol test meeting the

standards of this part and performed

within 60 days before the granting of

unescorted access may serve as the

return-to-duty test except in the case of

those who have been denied access

under the provisions of § 26.27(b). A

negative test result must be obtained

before the granting of unescorted access

unless the individual has no history

indicating the use of illegal drugs or the

abuse of legal drugs (e.g., alcohol,

prescription and over-the-counter drugs)

and either has had a negative test result

on a test meeting the standards of this

part performed within six months before

the reinstatement of unescorted access

or has been covered by a program

meeting the standards of this part for

two consecutive weeks during that

period.

* * * * *

(c) Licensees shall test specimens

collected under each type of test listed

in § 26.24(a) for all substances described

in paragraph 2.1(a) of the NRC

Guidelines (Appendix A to part 26). In

addition, licensees may consult with

local law enforcement authorities,

hospitals, and drug counseling services

to determine whether other substances

with abuse potential are being used in

the geographical locale of the facility

and the local workforce. When

appropriate, other substances so

identified may be added to the panel of

substances for testing. Appropriate cutoff limits must be established by the

licensee for these substances.

(d)(1) All collected urine and blood

specimens must be forwarded to a

laboratory certified by the Department

of Health and Human Services (HHS),

except that licensees may conduct tests

of aliquots to determine which

specimens are negative and need no

further testing, provided the licensee’s

staff possesses the necessary training

and skills for the tasks assigned, the

staff’s qualifications are documented,

and adequate quality controls for the

testing are implemented. All such

testing of specimens must include tests

to ensure specimen validity as required

by section 2.7(e) of Appendix A to part

26. Quality control procedures for

screening tests by a licensee’s testing

facility must include the processing of

blind performance test specimens and

the submission to the HHS-certified

laboratory of a sampling of specimens

initially analyzed as negative. Except for

the purposes discussed in § 26.24(d)(2),

access to the results of the above

screening tests must be limited to the

licensee’s testing staff, the Medical

Review Officer (MRO), the Fitness-forDuty Program Manager, and employee

assistance program staff, when

appropriate.

(2) An individual may not be removed

or temporarily suspended from

unescorted access or be subjected to

other administrative action based solely

on an unconfirmed positive result from

any drug test, other than for marijuana

(THC) or cocaine, unless other evidence

indicates that the individual is impaired

or might otherwise pose a safety hazard.

With respect to on-site screening tests

for marijuana (THC) and cocaine,

licensee management may be informed

and licensees may temporarily suspend

individuals from unescorted access or

from normal duties or take lesser
21136 Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules

administrative actions against the

individual based on an unconfirmed

positive test result provided the licensee

complies with the following conditions:

(i) For the drug for which action will

be taken, at least 85 percent of the

unconfirmed positive test results from

on-site screening tests during the last

12-month data reporting period

submitted to the Commission under

§ 26.71(d) were subsequently reported

as positive by the HHS-certified

laboratory as the result of a GC/MS

confirmatory test.

* * * * *

(iv) No disclosure of the temporary

removal or suspension of, or other

administrative action against, an

individual whose test is not

subsequently confirmed as a violation of

FFD policy may be made in response to

a suitable inquiry conducted under the

provisions of § 26.27(a), a background

investigation conducted under the

provisions of § 73.56, or to any other

inquiry or investigation. For the purpose

of assuring that no records have been

retained, access to the system of files

and records must be provided to

licensee personnel conducting appeal

reviews, inquiries into an allegation, or

audits under the provisions of § 26.80,

or to an NRC inspector or other Federal

officials. The tested individual must be

provided a statement that the records

specified in paragraph (d)(2)(iii) of this

section have not been retained and must

be informed in writing that the

temporary removal or suspension or

other administrative action that was

taken will not be disclosed and need not

be disclosed by the individual in

response to requests for information

concerning removals, suspensions,

administrative actions or history of

substance abuse.

(e) The period of time allowed

between the notification of the

individual and the actual collection of

a specimen must be kept at a minimum

consistent with operational constraints.

Whenever practicable, the individual

should not be allowed the time or

opportunity to obtain materials or take

any action that would subvert the

testing process or the test results.

(f) The Medical Review Officer shall

complete the review of test results

reported by the HHS-certified laboratory

and notify licensee management as soon

as practicable. The MRO shall report all

determinations of violations of the

licensee’s FFD policy (e.g., positive test

results and attempts to avoid detection)

to management in writing and in a

manner designed to ensure

confidentiality of the information. To

assure that action is taken immediately,

provisions must be made to ensure that

the MRO is able to contact appropriate

licensee management at any time.

Should the MRO’s review not be

completed within 14 days of the

collection of a specimen, licensee

management must be advised of

available test results, the status of the

review, the reasons for the delay, and

appropriate recommendations.

(g) All testing of urine specimens for

drugs, except screening tests performed

by licensees under paragraph (d) of this

section, must be performed in a

laboratory certified by the U.S.

Department of Health and Human

Services (HHS) for that purpose

consistent with its standards and

procedures for certification. Except for

suspect specimens submitted for special

processing (section 2.7(d) of Appendix

A to part 26), all specimens sent to

HHS-certified laboratories must be

subject to screening analysis by the

laboratory and all specimens screened

as unconfirmed positives must be

subject to confirmatory testing by gas

chromatography/mass spectroscopy

analysis by the laboratory. Licensees

shall submit blind performance test

specimens to HHS-certified laboratories

in accordance with the NRC Guidelines.

Licensees must ensure that all collected

specimens are tested and that

laboratories report results for all

specimens sent for testing, including

blind performance test specimens.

(h) Tests for alcohol must be

administered by breath analysis using

breath alcohol analyses devices meeting

evidential standards described in

section 2.7(p)(3) of Appendix A to part

26. If the screening test shows a breath

alcohol content indicating a BAC of 0.02

percent or greater, a confirmatory test

for alcohol must be performed using

another breath measurement

instrument. A confirmatory test result

showing a breath alcohol content

indicating a BAC between 0.02 percent

and 0.04 percent must be forwarded to

the MRO for evaluation as described in

section 2.9(h) of Appendix A to part 26.

A confirmatory test for alcohol

indicating a blood alcohol concentration

(BAC) of 0.04 percent or greater must be

declared a positive test. Further testing

for alcohol must be administered if

demanded by the individual for the

purposes of obtaining additional

information that could be considered

during an appeal pursuant to § 26.28.

Any such test must be a gas

chromatography analysis of blood

performed on a blood specimen drawn,

with the consent of the individual,

promptly after the confirmatory breath

analysis. Any detectable quantity of

alcohol in the blood specimen may be

considered, including extrapolation

back in time, to determine if a violation

of the FFD policy occurred.

(i) If an individual has a medical

condition that makes collection of

breath, blood, or urine specimens

difficult or hazardous, the MRO, in

consultation with the treating or

personal physician, may authorize an

alternative evaluation process, tailored

to the individual case, for determining

whether a violation of fitness-for-duty

policy has occurred, provided this

process includes measures to prevent

subversion and can achieve results

comparable to those produced by

urinalysis for illegal drugs and breath

analysis for alcohol.

11. Section 26.25 is revised to read as

follows:

§ 26.25 Employee assistance programs

(EAP).

Each licensee subject to this part shall

maintain an employee assistance

program to strengthen fitness-for-duty

programs by offering assessment, shortterm counseling, referral services, and

treatment monitoring to employees with

problems that could adversely affect the

performance of activities within the

scope of this part. Employee assistance

programs must be designed to achieve

early intervention. The EAP must also

provide for confidential assistance

except that the employee assistance

program staff shall inform licensee

management when a determination has

been made that any individual’s

condition constitutes a hazard to

himself or herself or others (including

those who have self-referred).

12. Section 26.27 is revised to read as

follows:

§ 26.27 Management actions and

sanctions to be imposed.

(a)(1)(i) Before the initial granting of

activities within the scope of this part,

as described in § 26.2(a), the licensee

shall obtain a written statement from the

individual as to whether he or she:

(A) Has in the past 5 years used, sold,

or possessed any illegal drugs, or had a

legal or employment action taken

against him or her for alcohol or drug

use;

(B) Has in the past 5 years been

determined to have violated a fitnessfor-duty policy, or as a result of action

taken in accordance with an FFD policy

been denied initial assignment to

activities within the scope of this part

as described in § 26.2(a), or has been

subject to a plan for treating substance

abuse (except for self-referral for

treatment); or

(C) Has at any time as a result of

action taken in accordance with an FFD
Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules 21137

policy been removed from activities

within the scope of this part as

described in § 26.2(a).

(ii) Power reactor licensees need not

obtain statements responding to the

activities listed in § 26.2(a)(3) unless the

background investigation conducted in

accordance with 10 CFR 73.56 indicates

the person was previously employed by

a licensee authorized to possess or

transport Category I nuclear material.

(2) The statement must include the

individual’s declaration as to the

specific type, duration, and resolution

of any such matter.

(3) The licensee shall complete a

suitable inquiry on a best-efforts basis to

verify the accuracy of the individual’s

written statement under paragraphs

(a)(1) and (a)(2) of this section. This

suitable inquiry should cover at least

the past 5 years but in no case less than

the past 3 years.

(4) If a record of the type described in

paragraphs (a) (1), (2), and (3) of this

section is established which raises a

concern about the person’s history of

alcohol or drug use, the new assignment

to activities within the scope of this part

or granting of unescorted access must be

based upon a management and medical

determination of fitness for duty and the

establishment of an appropriate followup testing program, as specified in

§ 26.24(a)(4). The restrictions of

paragraph (b) of this section must be

observed. To meet the suitable inquiry

requirement, the identity of persons

denied unescorted access or removed

under the provisions of this part and the

circumstances for the denial or removal,

including test results, will be made

available in response to a licensee’s,

contractor’s, or vendor’s inquiry

supported by a release signed by the

individual being investigated that

authorizes the disclosure of the

information. A suitable inquiry need not

be conducted for any period of 30 days

or less that the individual was not

covered by an FFD program meeting the

requirements of this part.

(5) Failure by an individual to list

reasons for removal or revocation of

unescorted access or failure to authorize

the release of information is sufficient

cause for denial of unescorted access.

Temporary unescorted access pursuant

to 10 CFR 73.56 may not be affected by

this part provided that the applicant for

unescorted access passes a chemical test

conducted according to the

requirements of § 26.24(a)(1).

(b) Each licensee subject to this part

shall, at a minimum, take the following

actions. The requirements of this

paragraph do not prohibit the licensee

from taking more stringent action.

(1) Personnel, including applicants,

who are impaired, those whose fitness

may be questionable, and those

determined to have violated the

licensee’s fitness-for-duty policy shall

be immediately denied unescorted

access or otherwise removed from

activities within the scope of this part.

These persons may be assigned to or

returned to their duties only after

impairing or questionable conditions are

resolved and the individual is

determined to be fit to safely and

competently perform activities within

the scope of this part by an appropriate

manager and a licensed physician

qualified to make the medical

determination of fitness.

(2) Lacking any other evidence to

indicate the use, sale, or possession of

illegal drugs or use of alcohol on site,

the following must be presumed to be

an indication of off-site drug or alcohol

use in violation of the company FFD

policy:

(i) A laboratory confirmed positive

test result that is verified by the MRO

as a policy violation; and

(ii) A confirmatory breath test for

alcohol that indicates the individual

had a BAC of 0.04 percent or greater

during any scheduled working tour.

(3) The first violation of the FFD

policy involving a confirmed positive

drug or alcohol determination must, at

a minimum, result in immediate

removal from activities within the scope

of this part for at least 14 days and

referral to the EAP for assessment and

counseling during any suspension

period. Plans for treatment, follow-up,

and future employment, if applicable,

must be developed, and any

rehabilitation program deemed

appropriate must be initiated during

such suspension period. Although the

individual must be removed from

activities covered by this part, the

individual must continue to be covered

during any suspension period by the

licensee’s FFD program with respect to

behavioral observation if in a work

status, chemical testing, and sanctions

for violations of the licensee’s FFD

policy. Before an individual is

permitted to be returned to duty or

assigned to perform activities within the

scope of this part, the individual must

be determined to be fit to safely and

competently perform such activities by

an appropriate manager and a licensed

physician qualified to make the medical

determination of fitness. A return-toduty test under § 26.24(a)(5) must be

conducted before the individual may be

returned to duty and follow-up testing

under § 26.24(a)(4) must be conducted

to verify continued abstinence from the

use of substances. Any subsequent

violation of FFD policy, including

during an assessment or treatment

period, must immediately result in

removal from activities described in

§ 26.2(a) for a minimum of 3 years from

the date of removal.

(4) Any individual determined to

have been involved in the sale, use, or

possession of illegal drugs or the use of

alcohol while, as applicable, within a

protected area of any nuclear power

plant, within a facility that is licensed

to possess or use SSNM, or within a

transporter’s facility or vehicle, must

immediately be removed from activities

within the scope of this part as

described in § 26.2(a) for a minimum of

5 years from the date of removal.

(5) Persons removed for periods of

three years or more under the provisions

of paragraphs (b)(2), (b)(3), (b)(4), and (c)

of this section and who would have

been removed under the current

standards of a hiring licensee, may be

granted unescorted access and assigned

duties within the scope of this part by

a licensee subject to this part only when

the hiring licensee receives satisfactory

medical assurance that the person has

abstained from the use of illegal drugs

or the abuse of legal drugs (e.g., alcohol,

prescription and over-the-counter drugs)

for at least three years. Before an

individual is permitted to be returned or

assigned to perform activities within the

scope of this part, the individual must

be determined to be fit to safely and

competently perform these activities by

an appropriate manager and a licensed

physician qualified to make the medical

determination of fitness. A return-toduty test under § 26.24(a)(5) must be

conducted before the individual may be

assigned duties and follow-up testing

under § 26.24(a)(4) must be conducted

to verify continued abstinence from the

use of substances. Any further violation

of FFD policy must immediately result

in permanent denial from activities

described in § 26.2(a).

(6) Paragraphs (b) (2), (3), (4), and (5)

of this section do not apply to valid

prescriptions or over-the-counter drugs.

Licensee sanctions for confirmed abuse

of valid prescription and over-thecounter drugs must be sufficient to deter

abuse of legally obtainable substances as

a substitute for abuse of proscribed

drugs.

(c) Any act or attempted act to subvert

the testing process must be a violation

of the licensee’s FFD policy and must

result in denial of unescorted access for

a minimum of 3 years. A refusal to

provide a specimen, effort to subvert the

testing process, or resignation before

removal for violation of company

fitness-for-duty policy concerning drugs

and alcohol must be recorded and
21138 Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules

provided in response to a suitable

inquiry. The specific cause for a

removal, e.g., that a laboratory

confirmed positive test result was

obtained and that the individual

resigned before an MRO review, must

also be provided in response to a

suitable inquiry. A record of these

actions must be retained for five years

following denial of any access

authorization for the purpose of meeting

the requirements of § 26.27(a).

(d) If a licensee has a reasonable belief

that an NRC employee or NRC

contractor may be under the influence

of any substance, or otherwise unfit for

duty, the licensee may not deny access

but shall escort the individual. In any

instance of this occurrence, the

appropriate Regional Administrator

must be notified immediately by

telephone. During other than normal

working hours, the NRC Operations

Center must be notified.

13. Section 26.28 is revised to read as

follows:

§ 26.28 Appeals.

Each licensee subject to this part, and

each contractor or vendor implementing

a fitness-for-duty program under the

provisions of § 26.23, shall establish a

procedure for licensee and contractor or

vendor employees and applicants for

unescorted access to appeal a

determination of a violation of FFD

policy. The procedure must provide

notice to the individual of the grounds

for the determination of a violation of

FFD policy, and must provide an

opportunity to respond and to submit

additional relevant information. The

procedure must provide for an objective,

impartial review of the facts relating to

the determination of a violation of FFD

policy. The review must be conducted

by persons not associated with the

administration of the FFD program, as

described in § 26.2(a)(4), and may

include internal management. If the

appeal is successful, the relevant

records must be corrected. A licensee

review procedure need not be provided

to employees of contractors or vendors

when the contractor or vendor is

administering its own alcohol and drug

testing.

14. In § 26.29, paragraph (b) is revised

and paragraph (c) is added to read as

follows:

§ 26.29 Protection of information.

* * * * *

(b) Licensees, contractors, and

vendors may not disclose the personal

information collected and maintained to

persons other than assigned Medical

Review Officers, other licensees,

contractors or vendors, or their

authorized representatives legitimately

seeking the information as required by

this part for unescorted access decisions

and who have obtained a release from

current or prospective employees or

contractor personnel, NRC

representatives, appropriate law

enforcement officials under court order,

the subject individual or his or her

representative, or to those licensee

representatives who have a need to have

access to the information in performing

assigned duties, including medical

determinations of fitness and audits of

licensee, contractor, and vendor

programs, to the presiding officer in a

judicial or administrative proceeding

initiated by the subject individual, to

persons deciding matters on review or

appeal, and to other persons pursuant to

court order. This section does not

authorize the licensee, contractor, or

vendor to withhold evidence of criminal

conduct from law enforcement officials.

(c) Upon receipt of a written request

by the subject individual, the licensee,

contractor, or vendor possessing such

records shall promptly provide copies of

all records pertaining to the

determination of a violation of the

licensee’s FFD policy, including test

results, MRO reviews, and management

determinations of results pertaining to

the subject individual. Records relating

to the results of any relevant laboratory

certification review or revocation of

certification proceeding shall be

obtained from the relevant laboratory

and provided to the subject individual

upon request.

15. In § 26.70, paragraph (b)(2) is

revised to read as follows:

§ 26.70 Inspections.

* * * * *

(b) * * *

(2) Duly authorized representatives of

the Commission may inspect, copy, or

take away copies of any licensee,

contractor, or vendor documents,

records, and reports related to

implementation of the licensee,

contractor, or vendor fitness-for-duty

program under the scope of the

contracted activities. This includes

documents, records, and reports of FFD

service contractors (e.g., contracted HHS

laboratory, MRO, EAP, and specimen

collection services) related to licensee,

contractor, or vendor FFD programs.

16. In § 26.71, paragraphs (b), (c) and

(d) are revised to read as follows:

§ 26.71 Recordkeeping requirements.

* * * * *

(b) Retain relevant records pertaining

to the determination of a violation of the

FFD policy and the related personnel

actions for a period of at least five years;

(c) Retain records of persons made

ineligible for three years or longer for

assignment to activities within the

scope of this part under the provisions

of § 26.27(b) (3), (4), and (5) or (c), until

the Commission terminates each license

under which the records were created;

and

(d) Collect and compile fitness-forduty program performance data on a

standard form and submit these data

covering the calendar year January 1st

through December 31st to the

Commission by March 1st of the

following year. The data for each site

(corporate and other support staff

locations may be separately

consolidated) must include: random

testing rate; drugs tested for and cut-off

levels, including results of tests using

lower cut-off levels and tests for other

drugs; workforce populations tested;

numbers of tests and results by

population, and type of test (i.e., preaccess, random, for-cause, etc.);

substances identified; summary of

management actions; number of

subversion attempts by type; and a list

of events reported. The data must be

analyzed and appropriate actions taken

to correct program weaknesses. The data

and analysis must be retained for three

years. Any licensee choosing to

temporarily suspend individuals under

the provisions of § 26.24(d) shall report

test results by process stage (i.e., on-site

screening, laboratory screening,

confirmatory tests, and MRO

determinations) and the number of

temporary suspensions or other

administrative actions taken against

individuals based on on-site

unconfirmed screening positives for

marijuana (THC) and for cocaine.

17. In § 26.73, paragraph (a) is revised

to read as follows:

§ 26.73 Reporting requirements.

(a) Each licensee subject to this part

shall inform the Commission of

significant fitness-for-duty events

including, but not limited to:

(1) Sale, distribution, use, possession,

or presence of illegal drugs or use of

alcohol within the protected area;

(2) Any acts by any person licensed

under 10 CFR part 55 to operate a power

reactor, by any supervisory personnel

assigned to perform duties within the

scope of this part, or by any FFD

program personnel as specified in

§ 26.2(a)(4)—

(i) Involving the sale, use, or

possession of a controlled substance;

(ii) Resulting in determinations that

such an individual has violated the

licensee’s FFD policy;

(iii) Involving use of alcohol within

the protected area; or
Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules 21139

(iv) Resulting in a determination of

unfitness for scheduled work due to the

consumption of alcohol;

(3) Any act that would cast doubt on

the honesty and integrity of the FFD

program personnel specified in

§ 26.2(a)(4); and

(4) Arrest of a worker for sale,

distribution, use, or possession of illegal

drugs on or off site.

* * * * *

18. In § 26.80, paragraphs (a) and (c)

are revised to read as follows:

§ 26.80 Audits.

(a) Each licensee subject to this part

shall audit the fitness-for-duty program

as needed but no less frequently than

every 36 months. Licensees are

responsible for determining the

appropriate frequency, scope, and depth

of auditing activities within the threeyear period based on review of program

performance indicators such as the

frequency, nature, and severity of

discovered problems, testing errors,

personnel or procedural changes,

previous audit findings, and ‘‘lessons

learned.’’ As soon as reasonably

practicable, but not later than 12 months

after a significant change in fitness-forduty personnel, procedures, or

equipment, licensees shall audit the

particular program element(s) affected

by that change to assure continued

program effectiveness. Program

elements which must continue to be

audited nominally every 12 months

include FFD program elements

implemented by contractors and

vendors under the provisions of § 26.23,

testing performed at HHS-certified

laboratories, and FFD services provided

to the licensee by contractors and

vendors off site or not under the direct

daily supervision or observation of

licensee personnel. Licensees may

accept audits of contractors and vendors

conducted by other licensees and need

not re-audit the same contractor or

vendor for the same period of time. Each

sharing utility shall maintain a copy of

the audit report, to include findings,

recommendations, and corrective

actions. Licensees retain responsibility

for the effectiveness of contractor and

vendor programs and the

implementation of appropriate

corrective action.

* * * * *

(c) The result of the audit, along with

recommendations, if any, must be

documented and reported to senior

corporate and site management. The

resolution of the audit findings and

corrective actions must be documented.

The documents must be retained for

three years.

Appendix A to Part 26—Guidelines for

Drug and Alcohol Testing Programs

19. Section 1.1 of Appendix A to part 26

is revised to read as follows:

1.1 Applicability

(a) These guidelines apply to licensees

authorized to operate nuclear power reactors

and licensees who are authorized to possess,

use, or transport formula quantities of

strategic special nuclear material (SSNM).

(b) Licensees may set more stringent cutoff levels than specified herein or test for

substances other than specified herein and

shall inform the Commission of such

deviation within 60 days of implementing

such change. Licensees may not deviate from

the other provisions of these guidelines

without the written approval of the

Commission.

(c) Only laboratories which are HHScertified are authorized to perform urine drug

testing for NRC licensees, vendors, and

licensee contractors.

20. Section 1.2 of Appendix A to part 26

is amended by removing all definitions

except chain-of-custody, collection site, and

collection site person, adding the definition

of limit of detection LOD, and revising the

introductory text to read as follows:

1.2 Definitions

In addition to the definitions contained in

§ 26.3, the following definitions apply:

* * * * *

Limit of Detection (LOD) means the lowest

concentration of an analyte that an analytical

procedure can reliably detect, which should

be significantly lower than the established

cut-off levels.

21. In section 2.1 of Appendix A to part 26,

paragraphs (a), (b), and (e) are revised to read

as follows:

2.1 The Substances

(a) Licensees shall, as a minimum, test for

marijuana, cocaine, opiates, amphetamines,

phencyclidine, and alcohol for pre-access,

for-cause, random, follow-up, and return-toduty tests.

(b) Licensees may test for any illegal drugs

and may consider any detected drugs or

metabolites when determining appropriate

action during a for-cause test or analysis of

any specimen suspected of being adulterated

or diluted (in vivo or in vitro), substituted,

or tampered with by any other means.

* * * * *

(e) This section does not prohibit

procedures reasonably incident to analysis of

a specimen for controlled substances (e.g.,

determination of pH or tests for specific

gravity, creatinine concentration, or presence

of adulterants).

22. In section 2.2 of Appendix A to part 26,

paragraphs (a), the introductory text to

paragraph (d), (d)(2) and (d)(4) are revised to

read as follows:

2.2 General Administration of Testing

(a) Use of a chain-of-custody form. The

original must accompany the specimen to the

HHS-certified laboratory. A copy must

accompany any split specimen. The form

must be a record on which is retained

identity data (or codes) on the individual

providing the specimen and information on

the specimen collection process and transfers

of custody of the specimen. Chain-of-custody

forms related to determinations of violations

of the FFD policy must be retained for a

period of at least five years following

termination of the individual’s unescorted

access authorization as required by

§ 26.71(b), or the completion of all legal

proceedings related to a positive test,

whichever is later. Chain-of-custody forms

recording specimens with negative test

results and no FFD violations or anomalies

may be destroyed after appropriate summary

information has been recorded for program

administration purposes.

* * * * *

(d) Written procedures, instructions, and

training must be provided as follows:

* * * * *

(2) A non-medical collection site person

shall receive training in compliance with this

appendix and shall demonstrate proficiency

in the application of this appendix before

serving as a collection site person. A medical

professional, technologist, or technician

licensed or otherwise approved to practice in

the jurisdiction in which collection occurs

may serve as a collection site person if that

person is provided the instructions described

in section 2.2(d)(3) of this appendix and

performs collections in accordance with

those instructions.

* * * * *

(4) The option to provide a blood specimen

for the purposes of obtaining additional

information that could be considered during

an appeal pursuant to § 26.28 following a

positive confirmatory breath test must be

specified in the written instructions provided

to individuals tested.

23. Section 2.3 of Appendix A to part 26

is revised to read as follows:

2.3 Preventing Subversion of Testing

Licensees shall carefully select and

monitor persons responsible for

administering the testing program (e.g.,

collection site persons, on-site testing facility

technicians, medical review officers, and

those selecting and notifying personnel to be

tested), based upon the highest standards for

honesty and integrity, and shall implement

measures to ensure that these standards are

maintained. At a minimum, these measures

must ensure that the integrity of such persons

is not compromised or subject to efforts to

compromise due to personal relationships

with any individuals subject to testing. At a

minimum:

(1) Supervisors, co-workers, and relatives

of the individual being tested shall not

perform any collection, assessment, or

evaluation procedures.

(2) Appropriate background checks and

psychological evaluations of the FFD

program personnel specified in § 26.2(a) must

be completed before assignment of tasks

directly associated with the licensee’s

administration of the program, and must be

conducted at least once every five years.

(3) Persons, specified in § 26.2(a),

responsible for administering the testing

program shall be subjected to a behavioral
21140 Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules

observation program designed to assure that

they continue to meet the highest standards

for honesty and integrity.

(4) FFD program personnel, specified in

§ 26.2(a), responsible for the administration

of testing must be subject to drug and alcohol

testing as specified in § 26.24(a). Fitness-forduty program personnel shall be tested by

personnel independent of the administration

of the FFD program to the extent practicable.

24. In section 2.4 of Appendix A to part 26,

paragraphs (d), (f), the introductory text of

paragraph (g), (g)(4), (5), (9) through (11), (13)

through (15), (18) through (20), (23) through

(25), and (27), (h), (i) and (j) are revised to

read as follows:

2.4 Specimen Collection Procedures.

* * * * *

(d) ‘‘Chain-of-Custody.’’ Licensee chain-ofcustody forms must be properly executed by

authorized collection site personnel upon

receipt of specimens. Handling and

transportation of urine and blood specimens

from one authorized individual or place to

another must always be accomplished

through chain-of-custody procedures. The

signature of the person (courier) picking up

the specimen being shipped to the HHScertified laboratory does not have to be

included on the chain-of-custody form as

long as specimens are sealed in tamperevident containers and there is a tracking

system that identifies the courier company

conveying the specimens to the laboratory,

includes a shipment billing or control

number, and requires the signature of the

courier. Every effort must be made to

minimize the number of persons handling

the specimens.

* * * * *

(f) ‘‘Privacy.’’ Procedures for collecting

urine specimens must allow individual

privacy unless there is reason to believe that

a particular individual may alter or substitute

the specimen to be provided. For purposes of

this appendix the following circumstances

are the exclusive grounds constituting a

reason to believe that the individual may

alter or substitute a urine specimen:

(1) The individual has presented, at this or

any previous collection, a urine specimen

that fails to meet the standards for an

acceptable specimen as provided in

paragraph (g)(15) of this section, or the

specimen is determined to be of questionable

validity under the provisions of

section 2.7 (e) of this appendix.

(2) The individual has presented a urine

specimen that falls outside the normal

temperature range, and the individual

declines to provide a measurement of oral

body temperature by sterile thermometer, as

provided in paragraph (g)(15) of this section,

or the oral temperature does not equal or

exceed that of the specimen.

(3) The last urine specimen provided by

the individual (i.e., on a previous occasion)

was determined to have a specific gravity of

less than 1.003 or a creatinine concentration

below .2 g/L.

(4) The collection site person observes

conduct clearly and unequivocally indicating

an attempt to substitute or adulterate the

specimen.

(5) The individual has previously been

determined to have used a substance

inappropriately or without medical

authorization and the particular test is being

conducted as a part of a rehabilitation

program or on return to service after

evaluation and/or treatment for a confirmed

positive test result.

(g) ‘‘Integrity and Identity of Specimens.’’

Licensees shall take precautions to ensure

that a urine specimen is not adulterated,

diluted, or tampered with during the

collection procedure, that a surrogate

specimen is not provided, that a blood

specimen or breath exhalent tube cannot be

substituted or tampered with, and that the

information on the specimen container and

in the chain-of-custody form can identify the

individual from whom the specimen was

collected. The following minimum

precautions must be taken to ensure that

authentic specimens are obtained and

correctly identified:

* * * * *

(4) After the individual has been positively

identified, the collection site person shall ask

the individual to sign a consent-to-testing

form. The individual shall not be required to

list prescription medications or over-thecounter preparations that he or she can

remember using.

(5) The collection site person shall ask the

individual to remove any unnecessary outer

garments such as a coat or jacket that might

conceal items or substances that could be

used to tamper with or adulterate the

individual’s urine specimen. The collection

site person shall ensure that all personal

belongings such as a purse or briefcase

remain with the outer garments outside of the

room in which the urine specimen is

collected. The individual may retain his or

her wallet.

* * * * *

(9) The collection site person shall note

any unusual behavior or appearance on the

chain-of-custody form.

(10) In the exceptional event that a

designated collection site is inaccessible and

there is an immediate requirement for urine

specimen collection (e.g., an accident

investigation), a public or on-site rest room

may be used according to the following

procedures. A collection site person of the

same gender as the individual shall

accompany the individual into the rest room

which shall be made secure during the

collection procedure. If practicable, a toilet

bluing agent must be placed in the bowl and

any accessible toilet tank. The collection site

person shall remain in the rest room, but

outside the stall, until the specimen is

collected. If no bluing agent is available to

deter specimen dilution, the collection site

person shall instruct the individual not to

flush the toilet until the specimen is

delivered to the collection site person. After

the collection site person has possession of

the specimen, the individual will be

instructed to flush the toilet and to

participate with the collection site person in

completing the chain-of-custody procedures.

If a collection site person of the same gender

is not available, the licensee shall select a

same gender person to accompany the

individual. This person shall be briefed on

relevant collection procedures.

(11) Upon receiving a urine specimen from

the individual, the collection site person

shall determine that it contains a quantity of

urine sufficient to meet specific licensee

testing program requirements. The quantity

collected must include at least 30 milliliters

for the primary specimen, and a sufficient

quantity for any on-site testing and testing for

any additional drugs. Where collected

specimens are split under the provisions of

section 2.7(k) of this appendix, an additional

15 milliliters must be collected. The total to

be collected should be of sufficient quantity

for all analyses and reanalyses and must be

predetermined by each licensee. If there is

less than the required quantity of urine in the

container, additional urine must be collected

to reach the required quantity. Each

successive void must be collected in a

separate container. (The temperature of any

partial specimen in its separate container

must be measured in accordance with

paragraph (g)(13) of this section, and the

partial specimens must be inspected and

sealed as described below for a full

specimen. Upon obtaining the required

amount, the partial specimens must be

combined in one container.) The individual

may be given a reasonable amount of liquid

to drink for this purpose (e.g., normally, an

8 oz. glass of water every 30 minutes, but not

to exceed a maximum of 24 oz.). If the

individual fails for any reason to provide a

sufficient quantity of urine, the collection

site person shall contact the appropriate

authority to obtain guidance on the action to

be taken.

* * * * *

(13) Immediately after the urine specimen

is collected, the collection site person shall

measure the temperature of the specimen.

The temperature measuring device used must

accurately reflect the temperature of the

specimen and not contaminate the specimen.

The licensee shall determine the temperature

range within which the specimen

temperature must fall based on the type of

temperature measuring devices used, and

shall clearly specify the temperature range in

its collection procedures. The temperature

range of an acceptable urine specimen must

be designated by the licensee and must be

within a band of 3 °C/6 °F or less, with a

lower limit not lower than 34 °C/94 °F. The

time from urination to temperature

measurement is critical and must in no case

exceed 4 minutes.

(14) Immediately after a urine specimen is

collected, the collection site person shall also

inspect the specimen to determine its color

and clarity and look for any signs of

contaminants or adulteration. Any unusual

findings must be noted on the chain-ofcustody form.

(15) An acceptable specimen is free of any

contaminants, meets the required quantity of

at least 30 ml, and is within the acceptable

temperature range and not less than 34 °C/

94 °F.

(i) An individual may volunteer to have his

or her oral temperature taken to provide

evidence to counter the reason to believe the

individual may have altered or substituted

the specimen caused by the specimen’s

temperature falling outside the prescribed

range.
Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules 21141

(ii) If there is a reason to believe that the

individual may have altered or substituted

the specimen because one or more of the

acceptance criteria is not met or there is other

reason to believe that the individual is

attempting to subvert the testing process,

another specimen must be collected

immediately under direct observation of a

same gender collection site person. If a

collection site person of the same gender is

not available, the licensee shall select a same

gender observer. The same measurements

must be performed on the second specimen,

and both specimens must be forwarded to the

laboratory for testing.

* * * * *

(18) Alcohol breath tests must be

performed by using evidential-grade

equipment as specified in section 2.7(o)(3) of

this appendix. The equipment must be

operated in accordance with the

manufacturer’s instructions by individuals

trained and proficient in the use of the

equipment. The screening test consists of

analyzing two breath specimens on the same

piece of equipment. If there is reason to

believe a source of alcohol in the mouth

exists (e.g., breath freshener or stomach

contents) and the testing device does not

have built-in protection for the condition, the

collection of the first screening breath

specimen must be delayed 15 minutes to

allow for dissipation of the material. If the

analysis of the first breath specimen is

essentially zero (less than 0.01 percent BAC),

the test is considered negative and no further

testing is required. For each individual

whose first screening breath specimen is at

or above 0.01 percent BAC, a second breath

specimen is to be collected and compared

after two minutes but no later than 10

minutes after the first specimen is collected.

If the two specimens are within plus or

minus 10 percent of the average of the two

measurements, then the test result is

considered accurate. If the tests of the two

specimens are not accurate, the series of two

breath tests must be repeated on another

evidential-grade breath analysis device

ensuring that the plus or minus 10 percent

accuracy is achieved. If the result of this

screening test is greater or equal to 0.02

percent BAC, a confirmatory test is to be

accomplished. The confirmatory test is a

repeat of the screening test procedure done

on another evidential-grade breath analysis

device.

(19) If the alcohol breath tests indicate that

the individual is positive for a BAC at or

above the 0.04 percent cut-off level or that

the individual may have been positive for a

BAC at or above the 0.04 percent cut-off level

during any scheduled working tour (i.e., has

a confirmatory test result between 0.02

percent BAC and 0.04 percent BAC), the

individual may request a blood test, at his or

her discretion, for the purposes of obtaining

additional information that could be

considered during an appeal. The blood

specimen should be drawn immediately, if

possible. If a blood specimen cannot be

drawn immediately, the procedure for

calculating a BAC level from delayed

collection of breath specimens and the

extrapolation of BAC results (as per section

26.24(h) and described in section 2.9(i) of

this appendix) must be followed for the

blood specimen. All vacuum tube and needle

assemblies used for blood collection must be

factory-sterilized. The collection site person

shall ensure that they remain properly sealed

until used. Antiseptic swabbing of the skin

must be performed with a nonethanol

antiseptic. Sterile procedures must be

followed when drawing blood and

transferring the blood to a storage container;

in addition, the container must be sterile and

sealed.

(20) Both the individual being tested and

the collection site person shall keep urine

and blood specimens in view at all times

before their being sealed and labeled. If a

urine specimen is split (as described in

section 2.7(k)) and if any specimen is

transferred to a second container, the

collection site person shall request the

individual to observe the splitting of the

urine sample or the transfer of the specimen

and the placement of the tamper-evident seal

over the container caps and down the sides

of the containers.

* * * * *

(23) The individual shall initial the

identification labels on the specimen bottles

for the purpose of certifying that it is the

specimen collected from him or her. The

specimen bottles must be securely sealed to

prevent undetected tampering. The

individual must also be asked to read and

sign a statement on the chain-of-custody form

certifying that the specimens identified as

having been collected from him or her are in

fact the specimens he or she provided.

(24) Agreement of the MRO, other

designated medical professional, or a higher

level supervisor of the collection site person,

must be obtained in advance of each decision

to obtain a urine specimen under direct

observation as specified in paragraph (g)(15)

of this section.

(25) The collection site person shall

complete the chain-of-custody forms for both

the primary specimen and the split

specimen, if collected, and shall certify

proper completion of the collection.

* * * * *

(27) While any part of the above chain-ofcustody procedures is being performed, it is

essential that the specimens and custody

documents be under the control of the

involved collection site person. The

collection site person must not leave the

collection site in the interval between

presentation of the specimen by the

individual and securement of the specimens

with identifying labels bearing the

individual’s specimen identification numbers

and seals initialed by the individual. If the

involved collection site person leaves his or

her work station momentarily, the sealed

specimens and chain-of-custody forms must

be taken with him or her or must be secured.

If the collection site person is leaving for an

extended period of time, the specimens must

be packaged for transfer to the laboratory

before he or she leaves the collection site.

(h) ‘‘Collection Control.’’ To the maximum

extent possible, collection site personnel

must keep the individual’s specimen

containers within sight both before and after

the individual has urinated or provided a

blood specimen. After the specimen is

collected and whenever urine specimens are

split, they must be properly sealed and

labeled to prevent undetected tampering. The

collection site person shall sign or initial and

date the specimen seal. A chain-of-custody

form must be used for maintaining control

and accountability of each specimen

including split specimens from the point of

collection to final disposition of the

specimen. The date and purpose must be

documented on the chain-of-custody form

each time a specimen is handled or

transferred, and every individual in the chain

of custody must be identified. Every effort

must be made to minimize the number of

persons handling specimens.

(i) ‘‘Specimen Preparation and

Transportation to Laboratory or Testing

Facility.’’ Collection site personnel shall

arrange to transfer the collected specimens to

the drug testing laboratory or licensee testing

facility. To minimize false negative results

from specimen degradation, specimens must

be sent to the HHS-certified laboratory as

soon as reasonably possible but in no case

should the time between specimen shipment

and receipt of the specimen at the HHScertified laboratory exceed 48 hours, or the

time between shipment and screening test at

the HHS-certified laboratory exceed 72 hours.

Collected urine specimens must be shipped

to the HHS-certified laboratory, or cooled to

not more than 6 degrees centigrade (42.8°F),

within 6 hours of collection. Sealed and

labeled specimen bottles being transferred

from the collection site to the drug testing

laboratory must be placed in a second,

tamper-evident shipping container which

must be designed to minimize the possibility

of damage to the specimen during shipment

(e.g., specimen boxes, padded mailers, or

bulk insulated shipping containers with that

capability) so that the contents of the

shipping containers are no longer accessible

without breaking a tamper-evident seal. The

collection site personnel shall ensure that the

chain-of-custody documentation is attached

to each urine specimen bottle.

(j) ‘‘Failure to Cooperate.’’ If the individual

refuses to cooperate with the urine collection

or breath analysis process (e.g., refusal to

provide a complete specimen, complete

paperwork, initial specimen), then the

collection site person shall inform the

appropriate authority and shall document the

non-cooperation on the specimen chain-ofcustody form. The failure to cooperate must

be reported immediately to the Medical

Review Officer, the FFD Program Manager, or

to other management having a need to know,

as appropriate, for further action. The

provision of a blood specimen for use in an

appeal of a positive breath test for alcohol

must be entirely voluntary, and must be at

the individual’s option.

25. In section 2.5 of Appendix A to part 26,

paragraph (a)(5) is revised to read as follows:

2.5 HHS-Certified Laboratory Personnel

(a) * * *

(5) This individual shall be responsible for

the laboratory’s having a procedure manual

which is complete, up-to-date, available for

personnel performing tests, and followed by

those personnel. The procedure manual must

be reviewed, signed, and dated by this
21142 Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules

responsible individual whenever procedures

are first placed into use or changed or when

a new individual assumes responsibility for

management of the laboratory. Copies of all

procedures and dates on which they are in

effect must be maintained. (Specific contents

of the procedure manual are described in

section 2.7(p) of this appendix).

* * * * *

26. In section 2.6 of Appendix A to part 26,

paragraph (a) is revised to read as follows:

2.6 Licensee Testing Facility Personnel

(a) ‘‘Day-to-Day Management of

Operations.’’ Any licensee testing facility

shall have an individual to be responsible for

day-to-day operations and to supervise the

testing technicians. This individual(s) shall

have at least a bachelor’s degree in the

chemical or biological sciences, medical

technology, or equivalent. He or she shall

have training and experience in the theory

and practice of the procedures used in the

licensee testing facility, resulting in his or

her thorough understanding of quality

control practices and procedures; the review,

interpretation, and reporting of test results;

maintenance of chain of custody; and proper

remedial actions to be taken in response to

detecting aberrant test or quality control

results.

* * * * *

27. Section 2.7 of Appendix A to part 26,

paragraphs (e) through (o) are redesignated (f)

through (p), new paragraphs (e), (f)(3), (g)(6),

and (p)(6) are added, and paragraphs (b)(1),

(c), (d), (f)(1), (g) (1), (2), (3), and (5), (h) (1),

(2), (3), (5), and (6), (i), (j), (k), (m)(2), (n), and

(p) (1), (2), and (3)(ii) are revised to read as

follows:

2.7 Laboratory and Testing Facility

Analysis Procedures

* * * * *

(b) ‘‘Receiving.’’ (1) When a shipment of

specimens is received, laboratory and the

licensee’s testing facility personnel shall

inspect each package for evidence of possible

tampering and compare information on

specimen containers within each package to

the information on the accompanying chainof-custody forms. Any direct evidence of

tampering or discrepancies in the

information on specimen containers and the

licensee’s chain-of-custody forms must be

reported by the HHS-certified laboratory

within 24 hours to the licensee and must be

noted on the laboratory’s chain-of-custody

form which must accompany the specimens

while they are in the laboratory’s possession.

Indications of tampering with specimens at a

testing facility operated by a licensee must be

reported within 8 hours to senior licensee

management.

* * * * *

(c) ‘‘Short-Term Refrigerated Storage.’’

Specimens that do not receive a screening

test and, if appropriate, a confirmatory test

within one day of arrival at the HHS-certified

laboratory, or are not shipped within 6 hours

of collection from the licensee’s collection or

testing facility, as well as any retained split

specimens, must be placed in secure

refrigeration units or other means of securely

maintaining the specimens in a chilled

condition until testing or shipment.

Temperatures must not exceed 6 °C/43 °F.

Contingency measures must be available to

maintain the specimens in a chilled state in

case of prolonged power failure.

(d) ‘‘Specimen Processing.’’ Urine

specimens identified as unconfirmed positive

or as questionable for adulteration or dilution

by a licensee’s testing facility must be

shipped to an HHS-certified laboratory for

testing. Laboratory facilities for drug testing

will normally process urine specimens by

grouping them into batches. The number of

specimens in each batch may vary

significantly depending on the size of the

laboratory and its workload. When

conducting either screening or confirmatory

tests at either the licensee’s testing facility or

an HHS-certified laboratory, every batch

must contain an appropriate number of

standards for calibrating the instrumentation

and a minimum of 10 percent controls. Both

quality control and blind performance test

specimens must appear as ordinary

specimens to laboratory analysts. Special

processing may be conducted to analyze

specimens suspected of being adulterated or

diluted (including hydration). Any evidence

of adulteration or dilution, and any detected

trace amounts of drugs or metabolites, must

be reported to the Medical Review Officer.

The Medical Review Officer shall report any

adulteration or dilution evidence (excluding

hydration resulting from an acceptable

reason) to management immediately.

(e) ‘‘Determining Specimen Validity.’’

Specimens must be tested at a licensee’s

testing facility, if the licensee conducts

screening tests, and at an HHS-certified

laboratory to determine their validity and to

detect evidence of adulteration or dilution.

At a minimum, such testing must include

analysis of specific gravity (SG) before being

subjected to screening testing. Devices used

to determine validity of the specimen must

be accurate and not contaminate the

specimen. A specimen acceptable for testing

using the cut-off levels in paragraphs (f)(1)

and (g)(2) of this section has a specific gravity

greater than 1.003 and is free of detectable

adulterants. Specimens determined to be of

questionable validity that show evidence of

dilution must be subject to both screening

and confirmation testing using the limit of

detection (LOD) that the laboratory is capable

of performing. If the specimen’s specific

gravity (SG) is less than 1.001, or if there is

reason to believe that the specimen has been

adulterated, the laboratory need not conduct

LOD testing and must report the possibly

adulterated or diluted condition to the

Medical Review Officer. When the MRO

cannot determine if the specimen is valid or

invalid, another specimen must be collected

as soon as possible under the provisions of

section 2.4(f) of this appendix.

(f) ‘‘ Onsite and Laboratory Screening

Tests.’’

(1) For the analysis of urine specimens, any

screening test performed by a licensee’s

testing facility and the screening test

performed by an HHS-certified laboratory

must use an immunoassay which meets the

requirements of the Food and Drug

Administration for commercial distribution.

The screening test of breath for alcohol

performed at the collection site must use a

breath measurement device which meets the

requirements of paragraph (p)(3) of this

section. The following initial cut-off levels

must be used when screening specimens to

determine whether they are negative for the

indicated substances:

SCREENING TEST CUT-OFF LEVEL

(ng/ml)

Marijuana metabolites .............. 50.

Cocaine metabolites ................. 300.

Opiate metabolites 1 ................. 300.

Phencyclidine ........................... 25.

Amphetamines .......................... 1,000.

Alcohol 2 .................................... 0.04% BAC.

1 25 ng/ml is immunoassay specific for free

morphine. 2Percent, by weight, of alcohol in a person’s

blood shall be based upon grams of alcohol

per 100 milliliters of blood or grams of alcohol

per 210 liters of breath.

In addition, licensees may specify more

stringent cut-off levels. In such cases, the

results of HHS screening tests must be

reported for both levels. Only the more

stringent tests need be conducted, and the

results for the cut-off levels above may be

calculated.

* * * * *

(3) Multiple screening tests (also known as

rescreening) for the same drug class may be

performed on:

(i) Unconfirmed positive specimens (e.g.,

an unconfirmed positive for amphetamines)

only when needed to reduce the effect of

possible cross reactivity due to structural

analogs;

(ii) Those specimens where a valid

analytical result cannot be obtained using

one particular immunoassay technique due

to interference in the assay (e.g., prescription

medication); or

(iii) Unconfirmed positive specimens that

appear to have a high concentration of drugs

or metabolites to determine an appropriate

dilution requirement for GC/MS confirmation

analysis.

(g) ‘‘Confirmatory Test.’’ (1) Specimens

which test negative as a result of a screening

test must be reported as negative to the

licensee and will not be subject to any further

testing unless special processing of the

specimen is desired because adulteration or

dilution is suspected.

(2) All urine specimens identified as

unconfirmed positive on the screening test

performed by a HHS-certified laboratory

must be confirmed using gas

chromatography/mass spectrometry (GC/MS)

techniques at the cut-off values listed in this

paragraph for each drug, or at the cut-off

values required by the licensee’s unique

program, where differences exist. All

confirmations must be made by quantitative

analysis. Concentrations which exceed the

linear region of the standard curve must be

documented in the laboratory record as

‘‘greater than highest standard curve value.’’
Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules 21143

CONFIRMATORY TEST CUT-OFF LEVEL

(ng/ml)

Marijuana metabolite 1 .............. 15.

Cocaine metabolite 2 ................. 150.

Opiates:

Morphine ............................... 300.

Codeine ................................. 300.

Phencyclidine 25.

Amphetamines: .....................

Amphetamine ........................ 500.

Methamphetamine 3 .............. 500.

Alcohol 4 ................................ 40.04%

BAC.

1 1Delta-9-tetrahydrocannabinol-9-carboxylic

acid. 2Benzoylecgonine.

3Specimen must also contain amphetamine

at a concentration ≥200 ng/ml. 4Percent, by weight, of alcohol in a person’s

blood shall be based upon grams of alcohol

per 100 milliliters of blood or grams of alcohol

per 210 liters of breath.

In addition, licensees may specify more

stringent cut-off levels. In such cases, the

results must be reported for both levels. Only

the more stringent tests need be conducted,

and the results for the cut-off levels above

may be calculated.

(3) The analytic procedure for analysis of

blood specimens voluntarily provided by

individuals testing positive for alcohol on a

breath test must be gas chromatography

analysis.

* * * * *

(5) Confirmatory tests for opiates must

include a test for 6-acetylmorphine (AM).

(6) Specimens that have a positive GC/MS

test result for amphetamines must be tested

for the d and l isomers. The results of this

additional test must be reported to the MRO.

Laboratory quality control and inspection

criteria must be included for this additional

test.

(h) ‘‘Reporting Results.’’ (1) The HHScertified laboratory shall report test results to

the licensee’s Medical Review Officer within

4 working days (6 for suspected

amphetamines) after receipt of the specimen

by the laboratory. Before any test result is

reported, the results of screening tests,

confirmatory tests, and quality control data,

as applicable, must be reviewed and the test

certified as an accurate report by the

responsible individual at the laboratory. The

report must identify the substances tested for,

whether positive or negative; the cut-off(s) for

each; the specimen number assigned by the

licensee; any indications of tampering,

adulteration, or dilution that may be present;

and the drug testing laboratory specimen

identification number.

(2) The HHS-certified laboratory and any

licensee testing facility shall report as

negative all specimens, except suspect

specimens being analyzed under special

processing, which are negative on the

screening test or negative on the confirmatory

test. Specimens testing positive on the

confirmatory analysis must be reported

positive for a specific substance. Except as

provided in § 26.24(d), unconfirmed positive

results of screening testing at the licensee’s

testing facility will not be reported to

licensee management. The MRO’s staff may

perform routine administrative support

functions, including receipt of test results

and scheduling interviews for the MRO.

(3) The Medical Review Officer may

routinely obtain from the HHS-certified

laboratory, and the laboratory must provide,

quantitation of test results. The Medical

Review Officer may only disclose

quantitation of test results for an individual

to licensee management if required in an

appeals process, or to the individual under

the provisions of § 26.29(c). (This does not

preclude the provision of program

performance data under the provisions of 10

CFR 26.71(d).) Quantitation of negative tests

for urine specimens shall not be disclosed,

except where deemed appropriate by the

Medical Review Officer for proper

disposition of the results of tests of suspect

specimens. Alcohol quantitation for a blood

specimen must be provided to licensee

management with the Medical Review

Officer’s evaluation.

* * * * *

(5) The laboratory shall retain the original

chain-of-custody form and must send only to

the Medical Review Officer certified true

copies of the original chain-of-custody form

and the test report. In the case of a

laboratory-confirmed positive or special

processing of suspect specimens, the

document must be signed by the individual

responsible for day-to-day management of the

drug testing laboratory or the individual

responsible for attesting to the validity of the

test reports. Laboratories must retain these

documents consistent with the requirements

contained in section 2.2(a) of this appendix.

(6) The HHS-certified laboratory and the

licensee’s testing facility shall provide to the

licensee official responsible for coordination

of the fitness-for-duty program a monthly

statistical summary of urinalysis and blood

testing and shall not include in the summary

any personal identifying information. Initial

test data from the licensee’s testing facility

and the HHS-certified laboratory, and

confirmation data from HHS-certified

laboratories must be included for test results

reported within that month. Normally this

summary must be forwarded from HHScertified laboratories by registered or certified

mail and from the licensee’s testing facility

not more than 14 calendar days after the end

of the month covered by the summary. The

summary must contain the following

information:

(i) Screening Testing:

(A) Number of specimens received;

(B) Number of specimens reported out; and

(C) Number of specimens screened positive

for:

(1) Marijuana metabolites;

(2) Cocaine metabolites;

(3) Opiate metabolites;

(4) Phencyclidine;

(5) Amphetamines; and

(6) Alcohol.

* * * * *

(i) ‘‘Long-Term Storage.’’ Long-term frozen

storage (¥20 °C or less) ensures that any

urine specimens that have been associated

with personnel actions will be available for

any necessary retest during administrative or

disciplinary proceedings. Unless otherwise

authorized in writing by the licensee, HHScertified laboratories shall retain and place in

properly secured long-term frozen storage for

a minimum of 1 year all specimens that have

been confirmed positive, or that have been

adulterated or diluted. Within this 1-year

period, a licensee or the NRC may request the

laboratory to retain the specimen for an

additional period of time. If no such request

is received, the laboratory may discard the

specimen after the end of 1 year. The

laboratory must maintain any specimens

under legal challenge for an indefinite

period. Any split specimens retained by the

licensee must be transferred into long-term

storage upon determination by the Medical

Review Officer that the specimen has a

laboratory confirmed positive test.

(j) ‘‘Retesting Specimens.’’ Because some

analytes deteriorate or are lost during

freezing and/or storage, quantitation for a

retest is not subject to a specific cut-off

requirement but must provide data sufficient

to confirm the presence of the drug or

metabolite. For the retesting of specimens

that have been determined to have been

adulterated or diluted, the retest need only

confirm that the specimen is not valid.

(k) ‘‘Split Specimens.’’ Urine specimens

may be split, at the licensee’s discretion, into

two parts at the collection site. One half of

such specimens (hereafter called the primary

specimen) must be analyzed by the licensee’s

testing facility or the HHS-certified

laboratory for the licensee’s purposes as

described in this appendix. The other half of

the specimen (hereafter called the split

specimen) may be withheld from transfer to

the laboratory, sealed, and stored in a secure

manner by the licensee until all processing

of the primary specimen has been completed.

If the primary specimen is determined to be

negative and free of any evidence of

subversion, the split specimen in storage may

be destroyed. If the unconfirmed positive

result of a screening test has been confirmed,

or if the primary specimen is determined to

have been subject to adulteration, dilution, or

other means of testing subversion, the tested

individual may request in a timely manner

(as established by the licensee, but not to be

restricted to less than 72 hours from the time

of the individual’s notification of the

screening test result) that the split specimen

be tested. The individual must be informed

of this option. The split specimen must be

forwarded on the day of the request to

another HHS-certified laboratory that did not

test the primary specimen. The chain-ofcustody and testing procedures to which the

split specimen is subject must be the same

as those used to test the primary specimen

and must meet the standards for retesting

specimens. In other words, the quantification

of the result is not subject to a specific cutoff requirement but must provide data

sufficient to confirm the presence of the drug

or metabolite (section 2.7(j) of this appendix).

The quantitative results of any second testing

process shall be made available to the

Medical Review Officer and to the individual

tested. Except as noted in this section, all

other requirements of this appendix

applicable to primary specimens shall also be

applicable to split specimens.

* * * * *
21144 Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules

(m) ‘‘Laboratory Facilities.’’

* * * * *

(2) HHS-certified laboratories must have

the capability, at the same laboratory

premises, of performing screening and

confirmatory tests for each drug and drug

metabolite for which service is offered and

for blood analysis for alcohol content (BAC).

Any licensee testing facilities must have the

capability, at the same premises, of

performing screening tests for each drug and

drug metabolite for which testing is

conducted. Breath tests for alcohol may be

performed at the collection site.

(n) ‘‘Inspections and Audits.’’ The NRC

and any licensee utilizing an HHS-certified

laboratory reserves the right to inspect or

audit the laboratory at any time. Licensee

contracts with HHS-certified laboratories for

drug testing and analyses of blood for alcohol

content (BAC), as well as contracts for

collection site services, must permit the NRC

and the licensee to conduct unannounced

inspections and audits and to obtain all

information and documentation reasonably

relevant to the inspections and audits.

Licensee contracts with HHS-certified

laboratories must also provide the licensee

and the NRC with the ability to obtain copies

of any documents, including reviews and

inspections pertaining to the laboratory’s

certification by HHS, and any other data that

may be needed to assure that the laboratory

is performing its testing and quality control

functions properly and that laboratory staff

and procedures meet applicable

requirements. Annual licensee inspections

and audits of HHS-certified laboratories must

include review of inspection reports made

under the HHS-certification program but

need not duplicate areas covered by the HHS

inspection. In addition, before the award of

a contract, the licensee shall carry out preaward inspections and evaluation of the

procedural aspects of the laboratory’s drug

testing operation. If an HHS-certified

laboratory loses its certification, in whole or

in part, a licensee is permitted to

immediately use an HHS-certified laboratory

that has been audited by another NRC

licensee having a compatible drug panel and

cut-off standards. The licensee shall audit the

newly contracted HHS-certified laboratory

within three months. The NRC reserves the

right to inspect a licensee’s testing facility at

any time.

* * * * *

(p) ‘‘Additional Requirements for HHSCertified Laboratories and Licensees’ Testing

Facilities.’’

(1) ‘‘Procedure manual.’’ Each laboratory

and licensee’s testing facility shall have a

procedure manual which includes the

principles of each test, preparation of

reagents, standards and controls, calibration

procedures, derivation of results, linearity of

methods, sensitivity of the methods, cut-off

values, mechanisms for reporting results,

controls, criteria for unacceptable specimens

and results, remedial actions to be taken

when the test systems are outside of

acceptable limits, reagents and expiration

dates, and references. Copies of all

procedures and dates on which they are in

effect must be maintained as part of the

manual. Each HHS-certified laboratory shall

retain a copy of its latest procedure manual

as a record until at least 2 years after it is no

longer under contract to an NRC licensee to

test specimens of urine for drugs. Each

licensee shall retain a copy of its latest

procedure manual as a record until it is no

longer conducting on-site testing of

specimens of urine for drugs. Superseded

material must be retained for at least three

years.

(2) ‘‘Standards and controls.’’ HHScertified laboratory standards shall be

prepared with pure drug standards which are

properly labeled as to content and

concentration. The standards must be labeled

with the following dates: when received;

when prepared or opened; when placed in

service; and expiration date. All standards

used to calibrate alcohol breath analysis

equipment and equipment used at licensees’

testing facilities for conducting screening

tests must be current and valid for their

purpose.

(3) ‘‘Instruments and equipment.’’

* * * * *

(ii) Alcohol breath analysis equipment

must be an evidential-grade breath alcohol

analysis device of a brand and model that

conforms to National Highway Traffic Safety

Administration (NHTSA) standards (49 FR

48855; December 14, 1984 or 58 FR 48705;

September 17, 1993) and to any applicable

State statutes.

* * * * *

(6) ‘‘Restrictions.’’ The laboratory shall not

enter into any relationship with a licensee’s

MRO that may be construed as a potential

conflict of interest or derive any financial

benefit by having a licensee use a specific

MRO.

28. In section 2.8 of Appendix A to part 26,

paragraphs (a), (b), (c), and (e) are revised,

and new paragraph (f) is added to read as

follows:

2.8 Quality Assurance and Quality Control

(a) ‘‘General.’’ HHS-certified laboratories

and the licensee’s testing facility shall have

a quality assurance program which

encompasses all aspects of the testing process

including, but not limited to, specimen

acquisition, chain of custody, security,

reporting of results, screening and

confirmatory testing, and validation of

analytical procedures. Quality assurance

procedures must be designed, implemented,

and reviewed to monitor the conduct of each

step of the process of testing for drugs.

(b) ‘‘Licensee’s Testing Facility Quality

Control Requirements for Screening Tests.’’

Because all unconfirmed positive licensee

facility screening tests for drugs are

forwarded to an HHS-certified laboratory for

screening and confirmatory testing when

appropriate, the NRC does not require

licensees to assess their testing facility’s false

positive rates for drugs. To ensure that the

rate of false negative tests is kept to the

minimum that the immunoassay technology

supports, licensees shall perform an

immunoassay test on all blind performance

test specimens and submit these and a

sampling of specimens screened as negative

from every test run to the HHS-certified

laboratory. The results reported by the

certified laboratory must be evaluated and

appropriate corrective actions taken. The

manufacturer-required performance tests of

the breath analysis equipment used by the

licensee must be conducted as set forth in the

manufacturer’s specifications.

(c) ‘‘Laboratory Quality Control

Requirements for Screening Tests at HHSCertified Laboratories.’’ (1) Each analytical

run of specimens to be screened must

include:

(i) Urine specimens certified to contain no

drug;

(ii) Urine specimens fortified with known

standards; and

(iii) Positive controls with the drug or

metabolite at or near the threshold (cut-off).

(2) In addition, with each batch of

specimens, a sufficient number of standards

must be included to ensure and document

the linearity of the assay method over time

in the concentration area of the cut-off. After

acceptable values are obtained for the known

standards, those values will be used to

calculate specimen data. Implementation of

procedures to ensure that carryover does not

contaminate the testing of an individual’s

specimen must be documented. A minimum

of 10 percent of all test specimens must be

quality control specimens. Laboratory quality

control specimens prepared from spiked

urine specimens of determined

concentration, must be included in the run

and should appear as normal specimens to

laboratory analysts. One percent of each run,

with a minimum of at least one specimen,

must be the laboratory’s own quality control

specimens.

* * * * *

(e) ‘‘Licensee Blind Performance Test

Procedures.’’ (1) Licensees shall only

purchase blind quality control materials that:

(i) Have been certified by immunoassay

and GC/MS; and

(ii) Have stability data which verify

performance of those materials over time.

(2) During the initial 90-day period of any

contract with an HHS-certified laboratory

(not including rewritten or renewed

contracts), each licensee shall submit blind

performance test specimens to the laboratory

within the amount of at least 20 percent of

the total number of specimens submitted (up

to a maximum of 100 specimens) or 30 blind

performance test specimens, whichever is

greater. Following the initial 90-day period,

a minimum of 3 percent of all specimens (to

a maximum of 25) or 10 blind performance

test specimens, whichever is greater, must be

submitted per quarter. Licensees should

make an attempt to submit blind performance

test specimens during the initial 90-day

period and per quarter thereafter at a

frequency that corresponds with the

submission frequency for other specimens.

(3) Approximately 50 percent of the blind

performance test specimens must be blank

(i.e., certified to contain no drug) and the

remaining specimens must be positive for

one or more drugs per specimen in a

distribution such that all the drugs for which

the licensee is testing are included in

approximately equal frequencies of

challenge. The positive specimens must be

spiked only with those drugs for which the

licensee is testing. In addition, 10 percent of

the positive blind specimens must be
Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules 21145

appropriately adulterated or diluted and

‘‘spiked’’ to 60 percent of the cut-off value to

challenge the laboratory’s ability to

determine specimen validity, as required by

section 2.7 (e) of this appendix.

(f) ‘‘Investigation of Errors and Other

Matters.’’

(1) The licensee shall investigate any

testing errors or unsatisfactory performance

discovered in 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 reflect adversely on the integrity of the

testing process. The investigation must

determine relevant facts and identify the root

cause(s) of the testing or process error when

possible. The licensee and the laboratory

shall take action to correct the cause of any

errors or the unsatisfactory performance that

are within their control. A record must be

made and retained for a minimum of three

years of the investigative findings and the

corrective action taken, and, where

applicable, that record must be dated and

signed by the individuals responsible for the

day-to-day management and operation of the

HHS-certified laboratory. The licensee shall

submit to the NRC a report of any incident

and action taken or planned within 30 days

of completion of the investigation. The NRC

shall ensure notification of the finding to

HHS.

(2) Should a false positive error occur on

a blind performance test specimen or on a

regular test specimen, the licensee shall

promptly notify the NRC. The licensee shall

require the laboratory to take corrective

action to minimize the occurrence of the

particular error in the future. If there is

reason to believe the error could have been

systematic, the licensee may also require

review and reanalysis of previously run

specimens.

(3) Should a false positive error be

determined to be technical or

methodological, the licensee shall instruct

the laboratory to submit to it all quality

control data from the batch of specimens

which included any false positive specimen.

In addition, the licensee shall require the

laboratory to retest all specimens analyzed

positive for that drug or metabolite from the

time of final resolution of the error back to

the time of the last satisfactory performance

test cycle. This retesting must be documented

by a statement signed by the individual

responsible for day-to-day management of the

laboratory’s substance testing program. The

licensee and the NRC may require an on-site

review of the laboratory which may be

conducted unannounced during any hours of

operation of the laboratory. Based on

information provided by the NRC, HHS has

the option of revoking or suspending the

laboratory’s certification or recommending

that no further action be taken if the case is

one of less serious error in which corrective

action has already been taken, thus

reasonably assuring that the error will not

occur again.

29. Section 2.9 of Appendix A to part 26

is revised to read as follows:

2.9 Reporting and Review of Results

(a) ‘‘Medical Review Officer shall review

results.’’ An essential part of a licensee’s

testing program is the final review of results.

A laboratory confirmed positive test result

does not automatically identify a nuclear

power plant worker as having used

substances in violation of the NRC’s

regulations or the licensee’s company

policies. An individual with a detailed

knowledge of possible alternate medical

explanations is essential to the review of

results. This review must be performed by

the Medical Review Officer before the

transmission of results to licensee

management officials.

(b) ‘‘Medical Review Officer—

qualifications and responsibilities.’’ The

Medical Review Officer shall be a licensed

physician with knowledge of substance abuse

disorders. The MRO may be a licensee or

contract employee. However, the MRO shall

not be an employee or agent of or have any

financial interest in a laboratory or a

contracted operator of an on-site testing

facility whose drug testing results the MRO

is reviewing for the licensee. Additionally,

the MRO shall not derive any financial

benefit by having the licensee use a specific

drug testing laboratory or on-site testing

facility operating contractor or have any

agreement with such parties that may be

construed as a potential conflict of interest.

The role of the Medical Review Officer is to

review and interpret laboratory confirmed

positive test results obtained through the

licensee’s testing program and to identify

evidence of subversion of the testing process.

The MRO is also responsible for identifying

issues associated with the collection and

testing of specimens, and advising and

assisting management in the planning and

oversight of the overall FFD program. In

carrying out this responsibility, the Medical

Review Officer shall examine alternate

medical explanations for any laboratory

confirmed positive test result (this does not

include confirmation of blood alcohol levels

obtained through the use of a breath alcohol

analysis device). This action could include

conducting a medical interview with the

individual, review of the individual’s

medical history, or review of any other

relevant biomedical factors. The Medical

Review Officer shall review all medical

records made available by the tested

individual when a laboratory confirmed

positive test could have resulted from legally

prescribed medication. The Medical Review

Officer shall not consider the results of tests

that are not obtained or processed in

accordance with this appendix, although he

or she may consider the results of tests on

split specimens in making his or her

determination, as long as those split

specimens have been stored and tested in

accordance with the procedures described in

this appendix.

(c) ‘‘MRO Verification of Positive Test

Results.’’ Before making a final decision to

verify a laboratory confirmed positive test

result, the Medical Review Officer shall give

the individual an opportunity to discuss the

test result with him or her. Following

verification of a laboratory confirmed

positive test result as a violation of FFD

policy, the Medical Review Officer shall, as

provided in the licensee’s policy,

immediately notify the applicable employee

assistance program and the licensee’s

management official empowered to

recommend or take administrative action (or

the official’s designated agent). Unconfirmed

test results must not be reported except as

provided by § 26.24(d).

(d) ‘‘Verification for opiates.’’ Before the

Medical Review Officer verifies a laboratory

confirmed positive result as a violation of

FFD policy and the licensee takes action for

opiates, he or she shall determine that there

is reasonable and substantial clinical

evidence—in addition to the urine test—of

unauthorized use of any opium, opiate, or

opium derivative (e.g., morphine/codeine).

Clinical evidence may include substantial

evidence of a significant lack of reliability or

trustworthiness on the part of the worker.

Clinical signs of abuse include recent needle

tracks or test results that are inconsistent

with the ingestion of food or medication

including prescription medications

containing opiates (e.g., 6–AM test); clinical

signs of abuse also include behavioral and

psychological signs of acute opiate

intoxication or withdrawal. This requirement

does not apply if the GC/MS confirmation

testing for opiates confirms the presence of

6-acetylmorphine.

(e) ‘‘Reanalysis authorized.’’ Should any

question arise as to the accuracy or validity

of a laboratory confirmed positive test result,

only the Medical Review Officer is

authorized to order a reanalysis of the

original specimen and such retests are

authorized only at laboratories certified by

HHS. The Medical Review Officer shall

authorize a reanalysis of the original aliquot

on timely request (as established by the

licensee, but not to be restricted to less than

72 hours from the time of the individual’s

notification of the laboratory confirmed

positive test result) of the individual tested,

and shall also authorize an analysis of any

split specimen stored by or for the licensee

under the provisions of section 2.7(k) of this

appendix.

(f) ‘‘Results consistent with responsible

substance use.’’ If the Medical Review Officer

determines that there is a legitimate medical

explanation for the laboratory confirmed

positive test result, and that the use of the

substance identified through testing was in

the manner and at the dosage prescribed, and

the results do not reflect a lack of reliability

or trustworthiness, then there has not been a

violation of licensee policy. The Medical

Review Officer shall report the test result to

the licensee as negative. The Medical Review

Officer shall further evaluate the result and

medical explanation to determine if there is

a potential risk to public health and safety of

the individual being impaired on duty from

the substance or from the medical condition.

If the MRO determines that such a risk exists,

he or she shall conduct a medical

determination of fitness.

(g) ‘‘Medical determination of fitness.’’ (1)

Occasions when a medical determination of

fitness, as defined in § 26.3, must be

conducted include, but are not limited to, the

following:

(i) When an alternative medical

explanation explains the test result but there

is a basis for believing impairment on duty

could exist, as described in paragraph (f) of

this section;
21146 Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Proposed Rules

(ii) In the evaluation of all for-cause test

results;

(iii) Before making return-to-duty

recommendations subsequent to a worker’s

removal from duty in accordance with

§ 26.27(b) or the licensee’s fitness-for-duty

policy;

(iv) Before an individual being granted

unescorted access when a statement from an

individual obtained pursuant to § 26.27(a)

shows a history of substance abuse or record

of prior fitness-for-duty violations; and

(v) If a history of substance abuse is

otherwise identified.

(2)(i) If the licensed physician or MRO

determines that there is neither conclusive

evidence of a policy violation nor a

significant basis for concern that the

individual may be impaired while on duty,

then he or she shall report the result as

negative.

(ii) If the licensed physician or MRO

determines that there is not conclusive

evidence of a policy violation but that there

is a significant basis for concern that the

individual may be impaired while on duty,

then he or she shall report the result as not

representing an FFD violation but as a

condition under which the individual may

not be able to safely and competently

perform duties. Because these results should

not constitute a violation of the licensee’s

policy or the NRC rule, punitive actions

under the rule should not be taken based

upon the results. However, the licensed

physician, MRO, or the licensee management

personnel who are empowered to take

appropriate actions shall initiate actions to

ensure that any possible limiting condition

does not represent a threat to workplace or

public health and safety. When deemed

appropriate, the matter may also be referred

to the EAP.

(h) Breath alcohol content indicating a

blood alcohol concentration between 0.02

percent and 0.04 percent must be reported to

the MRO for review and evaluation. The

MRO shall determine whether it is

appropriate to extrapolate back in time to

estimate the highest BAC that the worker had

while on duty with the assumption that no

alcohol was consumed while on duty. In

these cases, the MRO will calculate a range

of possible peak BACs that could have

existed while the worker was on duty and

make a determination whether the result is

a confirmed positive test for alcohol. A

similar extrapolation process must be

conducted for the results of an analysis of a

blood specimen for alcohol, as provided by

§ 26.24(h).

(i) ‘‘Result scientifically insufficient.’’

Additionally, the Medical Review Officer,

based on review of inspection reports, quality

control data, multiple specimens, and other

pertinent results, may determine that the

result is scientifically insufficient for further

action and declare the test specimen

negative. In this situation, the Medical

Review Officer may request reanalysis of the

original specimen before making this

decision. The Medical Review Officer may

request that reanalysis be performed by the

same laboratory, or that an aliquot of the

original specimen be sent for reanalysis to an

alternate laboratory which is certified in

accordance with the HHS Guidelines. The

licensee’s testing facility and the HHScertified laboratory shall assist in this review

process as requested by the Medical Review

Officer by making available the individual(s)

responsible for day-to-day management of the

licensee’s test facility, of the HHS-certified

laboratory or other individuals who are

forensic toxicologists or who have equivalent

forensic experience in urine drug testing, to

provide specific consultation as required by

the licensee. The licensee shall maintain for

a minimum of three years, records that

summarize any negative findings based on

scientific insufficiency and shall make them

available to the NRC on request, but shall not

include any personal identifying information

in such reports.

Appendix A [Amended]

30. Section 3.2 of Appendix A is removed.

31. In section 4.1 of Appendix A to part 26

is revised to read as follows:

4.1 Use of HHS-Certified Laboratories

(a) Licensees subject to this part and their

contractors shall use only laboratories

certified under the HHS ‘‘Mandatory

Guidelines for Federal Workplace Drug

Testing Programs’’, Subpart C—‘‘Certification

of Laboratories Engaged in Urine Drug

Testing for Federal Agencies,’’ (53 FR 11970,

11986–11989) dated April 11, 1988, and

subsequent amendments thereto for

screening and confirmatory testing except for

screening tests at a licensee’s testing facility

conducted in accordance with § 26.24(d).

Information concerning the current

certification status of laboratories is available

from: The Division of Workplace Programs,

Substance Abuse and Mental Health Services

Administration, Room 13–A–54, 5600

Fishers Lane, Rockville, Maryland 20857.

(b) Licensees or their contractors may use

only HHS-certified laboratories that agree to

follow the same rigorous chemical testing,

quality control, and chain-of-custody

procedures when testing for more stringent

cut-off levels as may be specified by licensees

for the classes of drugs identified in this part,

for analysis of blood specimens for alcohol,

and for any other substances included in

licensees’ drug panels. Because the HHScertification process does not apply to these

matters, the defensibility of such tests

depends on appropriate measures by

licensees to assure the reported test results

are valid.

(c) All contracts related to this part

between licensees and their contractors and

HHS-certified laboratories must require

implementation of all obligations of this

appendix applicable to HHS-certified

laboratories.

Dated at Rockville, Maryland, this 29th day

of April, 1996.

For the Nuclear Regulatory Commission.

John C. Hoyle,

Secretary of the Commission.

[FR Doc. 96–11046 Filed 5–8–96; 8:45 am]

BILLING CODE 7590–01–P

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. 96–CE–16–AD]

RIN 2120–AA64

Airworthiness Directives; Pilatus

Britten-Norman Ltd. (formerly BrittenNorman) BN–2A and BN2A MK. 111

Series Airplanes

AGENCY: Federal Aviation

Administration, DOT.

ACTION: Notice of proposed rulemaking

(NPRM).

SUMMARY: This document proposes to

supersede Airworthiness Directive (AD)

75–26–15, which currently requires

repetitively inspecting the aileron mass

balance clamp unit attachment for

looseness on Pilatus Britten-Norman

Ltd. (Pilatus Britten-Norman) BN–2A

and BN2A MK. 111 series airplanes, and

modifying the aileron and mass balance

clamp unit if any looseness is found.

The Federal Aviation Administration’s

policy on aging commuter-class aircraft

is to eliminate or, in certain instances,

reduce the number of certain repetitive

short-interval inspections when

improved parts or modifications are

available. The proposed action would

retain the repetitive inspections

required by AD 75–26–15, and would

require modifying the aileron and mass

balance unit (at a certain time) as

terminating action for the repetitive

inspections. The actions specified in the

proposed AD are intended to prevent

failure of the aileron mass balance

attachment, which could result in loss

of control of the airplane.

DATES: Comments must be received on

or before July 19, 1996.

ADDRESSES: Submit comments on the

proposal in triplicate to the Federal

Aviation Administration (FAA), Central

Region, Office of the Assistant Chief

Counsel, Attention: Rules Docket No.

96–CE–16–AD, Room 1558, 601 E. 12th

Street, Kansas City, Missouri

64106.Comments may be inspected at

this location between 8 a.m. and 4 p.m.,

Monday through Friday, holidays

excepted.

Service information that applies to the

proposed AD may be obtained from

Pilatus Britten-Norman Limited,

Bembridge, Isle of Wight, United

Kingdom PO35 5PR; telephone 44–1983

872511; facsimile 44–1983 873246. This

information also may be examined at

the Rules Docket at the address above.

FOR FURTHER INFORMATION CONTACT: Ms.

Dorenda Baker, Program Officer,