79462 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

DEPARTMENT OF TRANSPORTATION

Office of the Secretary

49 CFR Part 40

[Docket OST–99–6578]

RIN 2105–AC49

Procedures for Transportation

Workplace Drug and Alcohol Testing

Programs

AGENCY: Office of the Secretary, DOT.

ACTION: Final rule.

SUMMARY: The Department of

Transportation is revising its drug and

alcohol testing procedures regulation.

The purposes of the revision are to make

the organization and language of the

regulation clearer, to incorporate

guidance and interpretations of the rule

into its text, and to update the rule to

include new provisions responding to

changes in technology, the testing

industry, and the Department’s program.

EFFECTIVE DATES: The amendments to

the current 49 CFR part 40 are effective

January 18, 2001. The revised 49 CFR

Part 40 is effective August 1, 2001.

FOR FURTHER INFORMATION CONTACT:

Robert C. Ashby, Deputy Assistant

General Counsel for Regulation and

Enforcement, 400 7th Street, SW., Room

10424, Washington DC, 20590, 202–

366–9310 (voice), 202–366–9313 (fax),

or bob.ashby@ost.dot.gov (e-mail); Mary

Bernstein, Director, Office of Drug and

Alcohol Policy and Compliance

(ODAPC), 400 7th Street, SW., Room

10403, Washington DC, 20590, 202–

366–3784 (voice), 202–366–3897 (fax),

or mary.bernstein@ost.dot.gov (e-mail);

or Jim L. Swart, Drug and Alcohol

Policy Advisor, ODAPC , same address

and phone numbers as above,

jim.swart@ost.dot.gov (e-mail).

SUPPLEMENTARY INFORMATION:

Background

The Department of Transportation

first published its drug testing

procedures regulation (49 CFR part 40)

on November 21, 1988 (53 FR 47002), as

an interim final rule. We based the rule

on the Department of Health and

Human Services (HHS) guidelines for

Federal agency employee drug testing,

with some changes to fit the

transportation workplace. The

Department published a final rule

responding to comments on the interim

rule a year later (54 FR 49854; December

1, 1989).

The Department added alcohol testing

procedures to Part 40 in a February 1994

final rule. This rule also made other

changes to Part 40, including

requirements for split samples in four

operating administration rules. Since

that time, the Department has amended

specific provisions of Part 40 on various

occasions (e.g., with respect to nonevidential alcohol screening devices and

‘‘shy bladder’’ procedures).

In the years since Part 40 was first

published, the Department issued a

large volume of guidance and over 100

written interpretations, as well as a

significant amount of informal advice.

Most of this material has not previously

been incorporated into the rule text.

There have been changes in testing

technology, the structure of the drug

and alcohol testing business, and the

functioning of the Department’s drug

and alcohol testing programs that make

it desirable to update our regulatory

provisions. Because the rule was

originally based on that of another

agency (i.e., HHS), there are some

provisions that never were a close fit for

the Department’s programs. Moreover,

the rule’s organization and language do

not meet the objectives of the Clinton

Administration’s current ‘‘Plain

Language’’ policies. Under section 610

of the Regulatory Flexibility Act,

agencies are directed to review existing

rules from time to time with an eye to

their effects on small businesses and

other small entities.

For all these reasons, the Department

decided to review Part 40. As a first

step, we issued an advance notice of

proposed rulemaking (ANPRM) on April

29, 1996 (61 FR 18713), asking for

suggestions for change in the rule. We

received 30 comments in response to

this ANPRM. We then issued a notice of

proposed rulemaking (NPRM) on

December 9, 1999 (64 FR 69076). This

NPRM proposed a comprehensive

revision to Part 40. In response to the

NPRM, we received letters from over

400 commenters, making around 4000

individual suggestions concerning the

rule. We also held three public listening

sessions, at which numerous interested

parties commented further on the

Department’s proposals, and we held an

internet forum. The final rule responds

to all the comments and makes

significant alterations to the existing

rules governing the Department’s drug

and alcohol testing programs.

Structure of the Rule

Perhaps the first thing readers will

notice about this final rule is that we

have thoroughly restructured Part 40,

with subparts organized by subject

matter area. Like the NPRM, and in

contrast to the existing rule, the text is

divided into many more sections, with

fewer paragraphs each on average, to

make it easier to find regulatory

provisions. The rule uses a questionanswer format, with language

specifically directing particular parties

to take particular actions (e.g., ‘‘As an

employer, you must * * *’’). We have

also tried to express the requirements of

the rule in plain language. Commenters

were very complimentary about the

reorganization of the rule, generally

praising it as much clearer and easier to

follow than the existing rule. The

Department received a plain language

award, known as the ‘‘No Gobbledygook

Award,’’ from Vice President Gore’s

National Partnership for Reinventing

Government in recognition of the

improved clarity of the regulation. We

have retained the NPRM’s format and

organization, which we believe will

help drug and alcohol testing program

participants understand and effectively

carry out this rule.

What matters most in a rulemaking is

not the number of letters favoring or

opposing a particular proposal. Our

central concern is with the substance of

the comments. In discussing comments

on this rule and our response to them,

we will focus on the substance of

positions that commenters expressed,

and on why we did or did not make

changes in response to various

comments. In writing the preamble, we

have avoided counting up the number of

comments supporting a given position

except in the most general way,

believing that doing so would distract

from the discussion of substantive

issues.

Effective Dates

The Department has decided to

establish an August 1, 2001, effective

date for the revised Part 40. We

recognize that there is always some

difficulty for everyone involved in the

transition between an existing rule and

a new rule. We hope that this delayed

effective date will ease the transition.

During the period between publication

and August 1, program participants will

have the opportunity to learn about new

provisions before having to implement

them. During this period, the

Department expects to develop and

issue guidance (e.g., a revised medical

review officer (MRO) manual) and make

presentations at a significant number of

conferences and training sessions. In

addition, August 1 is the date on which

use of the new Federal Drug Testing

Custody and Control Form (CCF), to

which the text of the revised Part 40

refers, becomes mandatory.

However, we believe it is important to

begin implementing some new

provisions sooner, since they enhance

the fairness and integrity of the process.

To do so, we must amend the existing

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79463

Part 40 to include these provisions, so

that they are in effect during the period

before the August 1 effective date of the

entire new version of the regulation.

Come August 1, the existing Part 40

(including the amendments we are

issuing today) will be replaced, in its

entirety, by the new Part 40. Since the

substance of today’s amendments will

be the same in both versions of the

document, there will be no change in

how we implement them after August 1.

The provisions requiring MRO review

and split specimen testing following

adulteration and substitution findings

will go into effect in 30 days. The

majority of laboratories already perform

validity testing on a voluntary basis.

Making the MRO review and split

specimen procedures effective in 30

days will make these additional

protections available in connection with

this existing validity testing. At the

same time, a provision explicitly

authorizing the continuation of this

existing practice under the new rule

will go into effect. To the extent that the

Department’s September 1998 guidance

memorandum concerning adulterated,

substituted, dilute, and unsuitable tests

is inconsistent with any provisions of

these amendments, we regard that

guidance as having been superseded on

the effective date of the amendments.

HHS is currently working mandatory

requirements for validity testing. HHS is

projecting completion of this project by

August 1, 2001. We believe that, to

avoid any potential uncertainty about

the standards and procedures for

mandatory validity testing, DOT should

put its mandate for validity testing into

effect simultaneously with the new HHS

requirements. Consequently, in the

event HHS has not issued its new

requirements by that date, we will

publish a subsequent Federal Register

notice postponing the Auust 1, 2001,

effective date for mandatory validity

testing.

Another provision that we are

including in the amendments to the

existing Part 40, and that will go into

effect in 30 days, is the public interest

exclusion system. These provisions are

very important to ensuring

accountability in the provision of drug

and alcohol testing. In addition, we are

making the provisions of § 40.5 effective

in 30 days as § 40.203, since the

Department expects to be issuing

guidance materials on the new Part 40

before August 1, 2001.

For readers’ convenience, here is a

table of the relationship between the

section numbers in the amendments to

current Part 40 that go into effect in 30

days and the section numbers of the

corresponding sections of the new,

revised Part 40 that goes into effect on

August 1, 2001:

Amended current part

40 New revised part 40

40.201 ......................... 40.3

40.203 ......................... 40.5

40.205 ......................... 40.89

40.206 ......................... 40.91

40.209 ......................... 40.93

40.211 ......................... 40.95

40.213 ......................... 40.99

40.215 ......................... 40.145

40.217 ......................... 40.179

40.219 ......................... 40.181

40.221 ......................... 40.183

40.223 ......................... 40.187

40.225 ......................... 40.191

Subpart F (same section numbers).Subpart R

Principal Policy Issues

In addition to often very detailed

paragraph-by-paragraph comments on

the text of the NPRM, commenters

focused on several major policy issues.

These included employee stand-down,

validity testing, the public interest

exclusion mechanism, the return-toduty process, transmission of test results

and other information through consortia

and third-party administrators,

reporting and storing information

through electronic means, and reporting

violations to DOT agencies. Issues also

arose concerning confidentiality of

information, conflicts of interest among

service providers, training, and the

collection process. In this preamble, we

will discuss these policy issues first.

After that, we will proceed to a sectionby-section discussion of the rule,

including the Department’s responses to

specific comments.

Stand-Down

Stand-down refers to an employer

practice of temporarily removing an

employee from performance of safetysensitive duties upon learning that the

individual had a confirmed laboratory

positive drug test, but before the MRO

has completed the verification process.

The existing regulation prohibits standdown. MROs are not permitted to

inform employers about the existence of

a confirmed laboratory positive test

pending verification, and employers are

not allowed to take any action

concerning an employee until they

receive the MRO’s notification of a

verified positive test.

The preamble to the NPRM noted the

reasons for the current policy: standdown undercuts the rationale for MRO

review, can compromise the

confidentiality of test results, and may

result in unfair stigmatization of an

employee as a drug user. While the

rationale for stand-down is that it

enhances safety, the Department has no

evidence that the current policy has

compromised safety. For example, we

are not aware of any case in which an

employee has had a drug-related

accident while verification of a

confirmed positive drug test was

pending.

The preamble also noted that some

employers advocated the use of standdown as a measure to enhance safety

and reduce liability. They wanted to use

this approach to eliminate, as far as

possible, any risk that someone who had

tested positive would be involved in an

accident before the MRO could

complete the verification process. We

noted that, essentially for this reason,

the Department’s own internal drug

testing program stood down some

employees (e.g., air traffic controllers) in

some circumstances following a report

of a confirmed positive laboratory test.

The NPRM regulatory text proposed

two alternatives, one of which

prohibited, and the other of which

permitted, stand-down. The alternative

that permitted stand-down included

requirements to help safeguard

employees’ interests in confidentiality

and fairness.

Comments

Comments were sharply, and fairly

evenly, divided on this issue. Some

commenters, mostly employers and

some service agents, supported standdown. A few of these comments went

further and urged that stand-down be

made mandatory, while a greater

number said that it should be

discretionary with each employer. A

smaller number of commenters,

including all unions and other

employee organizations as well as some

employers and service agents, opposed

permitting stand-down.

The most important argument cited by

stand-down supporters was safety.

Safety is a more important objective

than confidentiality, many of them said.

Even if there have not been documented

cases of safety problems occurring in the

absence of stand-down, no employer

wants to be the first to face such a

situation. Many employers may feel it so

important to stand down employees on

safety grounds that they would have an

incentive to violate this prohibition.

Avoiding unnecessary liability is also a

consideration: It would be unwise,

commenters said, to force a company to

permit an employee it knew had a

confirmed positive laboratory test to

continue driving a commercial truck or

flying a plane during the verification

process.

79464 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

Supporters also noted that, in most

cases, there were very low rates of

confirmed laboratory positive tests

being verified negative (indeed, some

drugs, like PCP, have no legitimate

medical uses that would support a

negative verification). Therefore, they

said, stand-down would not adversely

affect more than the small number of

drivers with confirmed positive

laboratory results that an MRO later

verified negative. Other commenters

said that adverse consequences for

employees could be minimized by

employers choosing to keep employees

in non-safety-sensitive positions until

verification or ensuring that employees

whose tests were ultimately verified

negative did not suffer any loss of pay

or other adverse consequences.

Opponents of stand-down said that

the practice embodied a ‘‘guilty until

proved innocent’’ approach that was

manifestly unfair and ignored the

purpose of having MRO review of

positive tests. Confidentiality provisions

would likely be inadequate. In practice,

the ‘‘word’’ would get out that the

employee had a confirmed laboratory

test result and the employee—even if

the MRO ultimately verified the test as

negative—would be stigmatized in the

workplace as a drug user. This would

upset the regulatory balance between

safety interests and the protection of

employees from unfair consequences of

the process. One motor carrier

association said that this would be a

particular problem in its industry. In

large carriers, an employee cannot be

taken out of service without

involvement by multiple management

employees. For unionized carriers in

which assignments are made by

seniority, it would be impossible to take

a driver out of service without other

drivers knowing it.

Some commenters contested the

safety rationale of stand-down by

pointing out that a positive drug test

does not indicate impairment. Other

commenters said that the risk to the

public from the current ‘‘no standdown’’ policy was minimal, given that

there were no known instances of

accidents resulting from the absence of

stand-down. Opponents also cited pay,

privacy, and personnel consequences, as

well as potential Americans with

Disabilities Act and other issues

potentially comploicating

implementation of stand-down.

An associated issue concerns pay

status. If a company stands down an

employee, should the company be

required to pay the employee during

this period, pending verification?

Several commenters directly addressed

this issue. About half of them, including

a union and some employers and their

associations, favored paying employees

while they were in a stand-down status.

The remainder said either that the

regulation should be silent on the issue,

with labor-management negotiations

deciding the matter in each case, or that

employees should not be paid while in

stand-down status.

While a number of comments

addressed confidentiality and privacy

issues, they provided little detail in the

way of suggestions for how best to

accomplish these objectives in a standdown situation. Likewise, while a few

commenters noted that confidentiality

might be a more difficult issue in small

companies, they did not provide any

suggestions for how to address the issue.

There was a suggestion that, to deal

with the situation of owner-operators in

the motor carrier industry, service

agents be empowered to stand down

these individuals.

DOT Response

At the time of the NPRM, the

Department recognized enough merit on

both sides of this argument to propose

alternative provisions. Having reviewed

the comments, we remain convinced

that advocates of both basic positions on

the issue make some strong points. The

Department is also aware that potential

future changes in drug testing

technology, such as the advent of HHSapproved on-site testing and alternative

testing methods, may alter the response

the Department’s procedures take

concerning stand-down in the future.

Consequently, the Department is taking

a middle-ground position on this

difficult issue.

The general rule will remain that

stand-down is prohibited. The reasons

for this general rule are the reasons

articulated in the existing rule, the

NPRM, and the comments from standdown opponents. However, we believe

it is necessary to respond to the genuine

and plausible safety concerns of

commenters favoring stand-down, the

fact that safety is the Department’s

highest priority, and the fact that the

Department’s internal program uses a

form of stand-down. Therefore, the

Department will establish a waiver

mechanism that permits employers, on

a case-by-case basis, to request DOT

agency approval for a specific, wellfounded stand-down plan that

effectively protect the interests of

employees.

This approach makes the

Department’s approach to its internal

and external programs consistent with

one another. When the Department, in

its role as an employer, wanted to use

a stand-down approach, it sought and

received a waiver from HHS, whose

drug testing guidelines also generally

prohibit stand-down. Under the final

rule, employers in the external program

who wish to employ stand-down can, in

an analogous way, seek a waiver from

the Department of Transportation.

We realize that some employers have

employees that are regulated by more

than one DOT agency. To avoid

unnecessary administrative burdens in

the waiver process, such an employer

would have to submit only one waiver

request, to the DOT agency that

regulated the largest number of its

employees. The various DOT agencies

involved would coordinate internally

before the lead agency responded to the

employer.

The Department intends to grant

waivers only to employers who present

a sound factual basis for their request

and will have in place a number of

provisions to protect employees’

legitimate interests. The final rule

(§ 40.21) lists several types of

information that the employer would

submit to the DOT agency in support of

its request. This information is intended

to give the DOT agency a picture of the

employer’s organization and safety

situation. For example, the size or

structure of the organization may affect

the ability of an employer to carry out

confidentiality requirements for the

grant of a waiver. An organization that

has an in-house MRO may be in a better

position to control access to testing

information than one that does not. An

organization that stands employees

down for reasons other than substance

abuse testing may be in a better position

to safeguard confidentiality than one

that does not. Organizations’ drug and

alcohol testing history may be a relevant

factor in determining whether standdown is useful in a particular company.

None of these kinds of information is

intended to establish a litmus test for

granting a waiver. DOT agencies will

make a case-by-case decision about the

merits of a stand-down petition with

respect to each company that applies for

one. DOT agencies will respond to each

petition in writing, with reasons for the

decision. DOT agencies are intended to

have wide discretion in making these

judgments. For example, two companies

might present stand-down policies that

are nearly identical on paper. However,

contextual factors in one company may

make its confidentiality assurances

credible as a practical matter, while in

the other case may suggest that

confidentiality could not practically be

maintained, despite the company’s good

faith efforts. DOT agencies could make

different decisions in the two cases. We

also point out that petitions for waivers

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79465

will be considered on a company-bycompany basis. DOT agencies will not,

for example, consider a petition from a

trade association or C/TPA on behalf of

an industry or segment of an industry.

As a condition for receiving a waiver,

the rule requires the employer to submit

its proposed written stand-down policy.

These requirements pertain to

confidentiality and protection of

legitimate employee interests and are

described in greater detail in the

discussion of § 40.21 below. One of

these requirements is that an employer

must continue to pay a worker who is

in stand-down status, in the same way

it would have in the absence of standdown. This is a matter of fairness. To

assume that the employee’s test will be

verified positive is to fall into the trap

of presuming the employee guilty until

proved innocent. In addition,

continuing normal pay status for the

employee should not be a major burden

for employers, given the usually short

interval before verification is completed.

As a major employer association

commented, most employers would not

object to paying the employees for a

reasonable amount of stand-down time

if they believe they will gain a

substantial safety benefit. An employer

who articulated a safety rationale for

stand-down but who objected to paying

employees in the brief interim would

seem to be an employer reluctant to

expend resources commensurate with

its expressed commitment to safety.

These conditions are intentionally

stringent. The Department wants to

ensure that only employers who are able

to maintain a successful balance

between the potential safety benefits of

stand-down and the legitimate privacy

interests of employees are permitted to

operate a stand-down policy. A DOT

agency can impose additional

conditions on a waiver or, if necessary,

revoke a waiver it once granted. A DOT

agency could also take enforcement

action against an employer that violated

the terms of its waiver.

Some comments suggested that standdown be permitted for confirmed

laboratory tests for some drugs (e.g.,

PCP) but not others (e.g., opiates), based

primarily on the lower or higher

probabilities of verified negatives for

these substances. The Department is not

including such a provision as a general

matter, out of concern that such a

provision might lead to confusion.

Public Interest Exclusions (PIE)

The NPRM proposed that service

agents—persons and organizations that

provide drug and alcohol testing

services to employers, such as

laboratories, MROs, substance abuse

professionals (SAPs), collectors, breath

alcohol technicians (BATs), screening

test technicians (STTs), consortia and

third-party administrators (C/TPAs)—

should be accountable for serious

noncompliance with Part 40. The NPRM

proposed a mechanism based on the

Department’s existing non-procurement

suspension and debarment rules (49

CFR part 29). This mechanism would

permit the Department, following a

series of procedures designed to ensure

fairness, to impose a public interest

exclusion (PIE). A PIE would direct

DOT-regulated employers not to use the

service agent for a period of time. The

Department proposed to use this

mechanism only in cases of serious

misconduct where the service agent has

not implemented prompt corrective

action following notice by a DOT

agency. The preamble noted that this

mechanism rested on the Department’s

existing authority to establish

requirements for the conduct of the drug

and alcohol testing process and to direct

employers to use only products and

services that met these standards.

Comments

The PIE proposal generated a good

deal of comment. Almost a hundred

written comments to the docket

addressed the proposal, which was also

the subject of extended discussion at the

Department’s three listening sessions,

where the Department convened forums

specifically on the subject. A strong

majority of employers and all unions

addressing the proposal favored it.

Among service agents and their

organizations, and other commenters

submitting written comments, about 60

percent opposed the proposal, as

written. Some service agent commenters

urged postponing consideration of the

provision and addressing it in a separate

rulemaking.

Even the commenters who opposed

the proposal said that they believed

service agents should be accountable for

their conduct, at least in principle.

Their reasons for opposing the proposal

included doubting the need for such a

mechanism and the Department’s

authority to implement it, a belief that

the proposed process was insufficiently

defined and did not provide enough

procedural safeguards for service agents,

a concern that DOT auditors and

inspectors might initiate PIE

proceedings arbitrarily, a preference for

other alternatives (e.g., additional

industry standards, certification,

training programs, litigation), or support

for other options mentioned in the

preamble to the NPRM (e.g.,

certification or self-certification by all

service agents with a DOT

decertification process).

Proponents of the proposal cited

examples of misconduct by service

agents for which there was no present

remedy. They said that employers,

especially small employers, often had to

take on faith the quality of service

agents, and the PIE process could help

them to know which service agents to

avoid. Employers also believed that it

was unfair for them to be solely

accountable for serious problems in the

testing process. Service agents who

supported the proposal said that it

would enhance the overall quality of

performance by service agents. Some

service agents cut corners to reduce

costs, putting more conscientious

service agents at a competitive

disadvantage, these commenters said,

and then ‘‘whined’’ when the

Department proposed a meaningful

accountability mechanism.

Commenters had a number of

thoughts on specific aspects of the

proposal. Many asked for greater

specificity concerning the kinds of

‘‘offenses’’ that would lead to a PIE

proceeding. DOT staff pointed out,

during the listening sessions and in

writing, that the PIE mechanism was

intended, both for policy and resource

reasons, to be used only in the case of

‘‘egregious’’ misconduct. However,

commenters pointed out that this

statement was not made in the proposed

regulatory text. They feared that

differences in interpretation among

inspectors and other DOT staff could

lead to the inconsistent or arbitrary use

of PIE proceedings. Some of these

commenters desired a specific list of the

actions that would lead to a PIE

proceeding, while others suggested the

Department should at least provide

examples.

Another frequently-made comment

concerned the scope of PIEs. The NPRM

said that a PIE would apply to all

divisions, organizational elements, and

types of services provided by a service

agent, unless the ODAPC Director

decided to limit its scope. Affiliates and

individual officers and employees could

also be subject to a PIE. A number of

service agents and employers objected

to this aspect of the proposal, saying it

was too broad. It was unfair, they said,

to prohibit employers from using a

service agent’s other services because of

a problem in one area. If a TPA has

violated the rule with respect to MRO

services, for example, why should a PIE

prevent an employer from using the

TPA for collection or SAP services?

Many commenters who made this point

favored an approach that came to be

known, in the listening sessions, as the

79466 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

‘‘slice of PIE.’’ Under this approach, a

PIE would apply only to the type of

service in which noncompliance had

taken place. Some commenters said the

‘‘slice’’ should be even narrower,

applying only to the specific employer,

facility, or individual service agent staff

members who had been involved in the

noncompliance. A few laboratories said

that laboratories should not be subject to

the PIE process, since HHS already

regulates laboratories through its

certification process. Another

commenter thought that it would be

better to fine erring service agents rather

than issuing a PIE.

Commenters raised two issues

concerning the role of the ODAPC

Director in the PIE process. A few

service agents suggested that the

Director would not be an objective

decisionmaker, because he or she would

be too sympathetic to the position of

DOT staff. Others suggested that the

‘‘firewall’’ between the Director and

other staff be made more explicit in the

regulatory text. Several service agent

commenters also asked for criteria for

determining the length of a PIE, as well

as a regulatory time frame for the

Director’s consideration of a service

agent’s petition to lift a PIE.

Smaller numbers of commenters

suggested other procedural changes in

the PIE provisions. One

recommendation was that the initiating

official’s burden of proof be ‘‘clear and

convincing evidence’’ instead of a

preponderance of the evidence. Others

asked for specific rules of evidence to

apply to PIE proceedings. Some asked

that the Department contact the service

agent first, to check on alleged facts,

before initiating a proceeding. A number

of employers asked for periods longer

than the proposed 90 days to replace a

service agent that was subject to a PIE,

or for the possibility of extensions of

that period. Some service agents asked

to delay the effective date of the PIE

provision by a year or two, to give

organizations time to get used to the

requirements of the new final rule. A

commenter asked that the rule provide

for a private right of action by

employers against service agents. Other

commenters disagreed with the

statement in the proposed rule text that

the purpose of a PIE was not

punishment.

DOT Response

1. Basic Rationale for the PIE Provisions

Service agents perform the bulk of

drug and alcohol testing services for

transportation employers. Employers,

particularly small employers,

necessarily rely on service agents to

comply with their testing obligations.

These employers often do not have the

expertise in testing matters that would

enable them to evaluate independently

the quality, or even the regulatory

compliance, of the work that service

agents perform for them. Yet an

employer’s compliance with DOT

regulations is largely dependent on its

service agents’ performance. If a service

agent makes a serious mistake that

results in the employer being out of

compliance with a DOT rule, the

employer alone is now accountable. The

employer may be subject to civil

penalties from a DOT agency. The

employer can be subject to litigation

resulting from personnel action it took

on the basis of the service agent’s

noncomplying services. Most

importantly, the employer’s efforts to

ensure the safety of its operations may

be damaged, as when an employee who

apparently uses drugs is returned to

duty because of a service agent’s

noncompliance. In many cases, there are

now no consequences to a service agent

who creates such problems, even if the

problems are serious.

The experience of DOT agencies,

which are responsible for reviewing

employers’ compliance, is that the vast

majority of employer noncompliance

results from service agent errors. (Given

the pervasive role of service agents in

performing testing functions, this is

probably not a disproportionate effect.)

FAA staff informally estimate, for

example, that more than nine out of ten

deficiencies their inspectors discover

result from service agent errors. In

addition, the Department’s drug and

alcohol testing office staff, from time to

time, encounter serious noncompliance

with DOT rules by service agents, for

which there is no present remedy. Here

are a few examples of actual cases we

have encountered:

• An MRO verified many tests

positive without conducting verification

interviews. As a result, the tests had to

be cancelled, and the employer had to

return the employees to duty, incurring

extra safety risks and costs.

• Another MRO, who had counterfeit

medical credentials, verified several

tests positive, bringing into question the

integrity of the verification process.

• In defiance of the clear language of

Part 40, a letter from the Department,

and a finding by a court, a laboratory

refused to provide an employee

information to which she was entitled.

• A service agent made false claims

that its personnel were certified by

DOT. DOT wrote them a letter telling

them to stop. Years later, the same

service agent’s letterhead continues to

make the same claims.

• A consortium and a laboratory were

engaged in a billing dispute with one

another. As a result, numerous preemployment results were not

transmitted to employers for a number

of months. No one informed the

employers of the problem, and some of

the employers, in the apparent belief

that ‘‘no news is good news,’’ placed

some of the workers—including one

who tested positive—in safety-sensitive

positions.

• A major employer used a service

agent for SAP services. The SAPs

provided by the service agent

established a long-standing pattern of

returning virtually all employees who

have tested positive to work quickly,

without education or treatment.

• Personnel of a major laboratory

engaged in misconduct apparently

involving the backdating and attempted

destruction of documents relevant to

litigation concerning a drug test result.

Attempting to deal with service agent

problems one employer at a time is both

inefficient and potentially unfair. It is

inefficient because service agents work

for many employers. It is potentially

unfair because employers may be

unwitting victims of service agent

misconduct. Conducting civil penalty

proceedings against several employers

because of the actions of one service

agent, moreover, does little if anything

to correct the conduct of the service

agent or protect other employers from

the consequences of its noncompliance.

In addition, service agents often work

for employers in more than one

transportation industry. For example, if

FRA takes action with respect to a

railroad whose noncompliance is

caused by service agent errors, this does

nothing to protect a motor carrier who

uses the same service agent.

The Department believes that, in this

situation, an accountability mechanism

that protects the public interest,

employers, and employees is

appropriate and necessary. A few

commenters appear to have

misunderstood the nature of the PIE

proposal. It is not an assertion of new

regulatory authority over service agents.

It makes use of the Department’s longstanding authority to direct

transportation employers not to use

products and services that do not meet

Federal standards. Employers may not

use laboratories that are not HHScertified. They may not use evidential

breath testing devices (EBTs) that are

not on the National Highway Traffic

Safety Administration (NHTSA)

conforming products list (CPL). They

may not use SAPs and MROs who fail

to meet regulatory qualifications. There

is no difference in legal principle

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79467

between these well-established

prohibitions and a requirement not to

use a service agent who has been found

to have seriously noncomplied with Part

40. A PIE is simply one additional

directive to transportation employers to

ensure that the employers use only

service providers that meet regulatory

requirements.

Procedurally, the PIE process is

modeled on a well-established

procedure for handling nonprocurement suspensions and

debarments. While not identical to the

non-procurement suspension and

debarment rules of the Department (49

CFR part 29), the PIE process draws on

Part 29 for many of its details. Modeling

PIE on an existing program that affords

due process to participants ensures that

PIE will be an effective and fair

approach to serious noncompliance in

the drug and alcohol testing program.

2. Legal Authority

The Department looked carefully at

the issue of legal authority before

proposing the PIE process in the NPRM.

As noted in the preamble to that

document, there is ample legal authority

to implement this proposal. First, there

is specific statutory authority for

rulemaking in this area. Section 322 of

the DOT Act provides general

rulemaking authority to the Secretary of

Transportation. It states that ‘‘[t]he

Secretary of Transportation may

prescribe regulations to carry out the

duties and powers of the Secretary.’’

Further, the 1991 Omnibus Act

authorizes the Secretary of

Transportation to continue in effect,

amend, or further supplement

regulations governing the use of alcohol

or a controlled substance. See 49 U.S.C.

31306(i), 49 U.S.C. 20140(f), 49 U.S.C.

5331(f)(3), and 49 U.S.C. 45106(c). Upon

review of the Act, it is clear that

Congress—while not explicitly

mentioning a particular mechanism to

ensure compliance—intended the

Secretary to use his or her discretion to

devise appropriate regulatory methods

to carry out the Department’s drug and

alcohol testing responsibilities.

Moreover, under well-settled case

law, specific statutory authority is not

needed in order for an agency to have

authority to impose a reasonable

requirement. There are many court

decisions that support this point,

particularly cases following Chevron v.

Natural Resources Defense Council, 467

U.S. 837 (1984). Chevron stands for the

proposition that courts will defer to

‘‘permissible’’ agency interpretations

where the statute is ‘‘silent or

ambiguous’’. In Chevron, the leading

case on the regulatory and interpretive

authority of agencies, the Supreme

Court articulated the following

standard:

When a court reviews an agency’s

construction of the statute it administers, it

is confronted with two questions. First,

always, is the question of whether Congress

has directly spoken to the precise question at

issue. If the intent of Congress is clear, that

is the end of the matter; for the court, as well

as the agency, must give effect to the

unambiguously expressed intent of Congress.

If, however, the court determines Congress

has not directly addressed the precise

question at issue, the court does not simply

impose its own construction of the statute, as

would be necessary in the absence of an

administrative interpretation. Rather, if the

statute is silent or ambiguous with respect to

the specific issue, the question for the court

is whether the agency’s answer is based on

a permissible construction of the statute. (Id.

at 842–43).

Numerous cases have reaffirmed this

standard. When courts have applied the

Chevron analysis to strike down an

agency regulation or interpretation, they

have not done so on the basis that a

statute did not speak to the issue at

hand. Rather, they did so because

something in the statute specifically

precluded the action the agency had

taken. It is clear that nothing in the

Department’s statutes precludes the

Department from instituting a procedure

like PIE.

To the contrary, the most important

statute authorizing the DOT drug and

alcohol testing program, the Omnibus

Transportation Employee Testing Act of

1991, confirms the Department’s broad

authority to carry out its drug and

alcohol testing responsibilities.

Congress intended that the Secretary use

his or her discretion and issue

supplementing regulations when

necessary to carry out the Department’s

drug and alcohol testing

responsibilities.

The DOT agency drug testing

regulations and Part 40 were originally

adopted in 1988–89 without any

specific statutory authority. These rules

were based on the DOT agencies’

general safety rulemaking authority and

the Department’s general rulemaking

authority. These DOT agency safety

statutes are silent with respect to drug

and alcohol testing. They do not

describe drugs to be tested, types of

tests, random testing rates, laboratories,

medical review officers, return-to-duty

procedures, testing equipment or

personnel, or any of the other subjects

addressed by DOT agency substance

testing rules and Part 40. Before the

Omnibus Act, these statutes provided

the only authority for the DOT agency

drug testing rules, and they still provide

the only authority for the RSPA and

Coast Guard rules. There was never any

question—aside from the original transit

rule—about the authority of the DOT

agencies to issue these rules. When

plaintiffs challenged these rules, they

and the courts focused on the

constitutional issues, mentioning the

agency’s authority for the rules only in

passing, since it was so clear.

Under Chevron, when the intent of

Congress is clear, as is the case here, no

further inquiry is necessary. This makes

it unnecessary for any reviewing court

to move on to the second prong of

Chevron. If a court did examine the PIE

provision under the second prong

however, there is little doubt that the

Department’s action is based on a

permissible construction of the statute.

The Department ’s decision to facilitate

employer compliance and protect

employers and employees from the

consequences of services that are

inconsistent with regulatory

requirements is reasonable. Each of the

requirements of Part 40 is important to

ensure the accuracy, integrity, privacy

and fairness of the testing process as

well as the safety of the public. If a

service agent fails or refuses to meet

these requirements, then these

important interests are adversely

affected.

As the testing program and the role of

service agents have evolved over ten

years, the Department has learned that

additional measures are needed to

ensure the proper provision of testing

services to employers. In every respect,

the proposed PIE process comes

squarely within the range of agency

actions which courts, applying Chevron,

have approved.

3. Alternatives

The Department believes that efforts

by industry groups to establish

certification programs, training

programs, and industry standards are

laudable and helpful. Such efforts,

however, do not address the issue of

accountability for service agents whose

noncompliance is serious. These

programs cannot respond, in a legally

binding way, with real consequences, to

protect employers and employees from

the misconduct of a party who makes

serious errors or chooses to noncomply

to gain an economic advantage.

An accountability mechanism like

that proposed in the NPRM would

effectively complement voluntary

industry efforts. By attaching tangible

consequences to serious

noncompliance, an accountability

mechanism would assist industry

groups in getting service agents to take

certification, training, and industry

standards programs seriously.

79468 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

Some commenters favored one or

more of the options discussed in the

NPRM preamble, such as certification or

self-certification followed by a DOT

decertification procedure or a contractbased mechanism. With respect to the

contract mechanism, comment was,

however, very divided, with many

commenters (in response to the PIE

proposals or proposed § 40.11) saying

that the contract clause requirement was

too burdensome or ineffective (i.e., with

respect to parties who typically do not

have written contracts). The Department

does not have the resources to operate

a Department-wide active certification

program (especially with respect to the

motor carrier industry). Maintaining a

data base for a self-certification program

would be difficult for the Department,

and there are significant issues

concerning keeping such a data base up

to date. For these reasons, we do not

believe that these options are preferable

to the PIE provisions the NPRM

proposed.

A few commenters supported reliance

on the legal system (i.e., court litigation)

as a tool for employers to use to address

problems caused by service agent

noncompliance. Nothing prevents

employers from resorting to private

litigation now or in the future. By

nature, however, such private litigation

focuses on vindicating the private

interests of the employer involved, not

in more broadly protecting testing

program participants and the public

interest. For this reason, we do not view

private litigation as a substitute for the

PIE provisions.

4. How Does a PIE Proceeding Begin?

Many service agent commenters asked

for greater clarity and specificity

concerning what ‘‘offenses’’ would be

sufficient to warrant starting a PIE

proceeding. They expressed the concern

that the NPRM proposal would give

DOT officials, including auditors and

inspectors, too much discretion to start

PIE proceedings based on minor

problems, despite the Department’s

statements that PIEs were intended to be

used in cases of ‘‘egregious’’

noncompliance.

As DOT officials said during the

listening sessions in PIE roundtables,

we do not think it is a good idea to have

a definitive list of offenses that would

trigger a proceeding. The Department’s

experience with this program suggests

that new situations will always arise.

We cannot possibly specify them all at

this time. A list that appeared definitive

could lead to arguments that the

Department was precluded from starting

a PIE proceeding because the underlying

conduct was not on a regulatory list.

Nevertheless, the Department does

believe it would make our intent and

policy clearer to state in the regulatory

text that this process is intended to be

used only for serious noncompliance.

We provide several examples of the

kind of noncompliance that would, as a

policy matter, have a level of

seriousness sufficient to warrant starting

a PIE proceeding. This regulatory text

provision also states that the list is not

exclusive or exhaustive: we retain the

discretion to start PIE proceedings in

situations not on the list and we are not

required to start a PIE proceeding every

time something on the list comes up.

We also make clear that not everyone

with a DOT ID card is authorized to start

a PIE proceeding. Only certain officials,

such as DOT agency drug and alcohol

program managers, are authorized to do

so. They may rely on credible

information from any source, including

but not limited to DOT auditors and

inspectors, as the basis for starting a

proceeding. As several commenters

requested, the final rule text provides

that the initiating official must contact

the service agent to get its side of the

story and any facts it can provide before

taking further action, such as issuing a

correction notice or a notice of proposed

exclusion (NOPE).

One issue on which commenters

spoke concerns the relationship of the

PIE process and the HHS certification

process for laboratories. With respect to

matters on which HHS takes

certification action against a laboratory,

the Department would defer to the HHS

action. That is, as a policy matter, the

Department would not start a PIE action

is HHS had already taken a certification

action against a laboratory on the same

matter. We do not believe it would be

an economical use of resources to have

two Federal proceedings in progress

with respect to the same laboratory, on

the same issues, at the same time.

However, if DHHS decided that it was

not appropriate to begin certification

action (e.g., because the laboratory’s

conduct did not trigger the HHS

‘‘imminent harm’’ standard), DOT could

consider whether to begin a PIE

proceeding.

One of the concerns that some

commenters expressed was that the very

existence of a PIE proceeding, regardless

of its ultimate outcome, could have

adverse economic effects on a service

agent. They asked that such proceedings

be kept confidential. The Department

does not believe that it is possible to

keep a PIE proceeding, or the events

leading up to it (e.g., a factual inquiry,

a correction notice) secret. For example,

in seeking to establish whether there is

a factual basis for a PIE proceeding,

DOT personnel might well have to ask

questions of a number of employers

about the service agent’s activities. On

the other hand, the Department will not

affirmatively seek to make pending

proceedings public knowledge, prior to

the issuance of a NOPE. For example,

we do not intend to issue a press release

or make other kinds of public

announcements at the time that we send

a correction notice to a service agent.

The issuance of a NOPE and the

Director’s decision, however, are

matters of public record.

5. Scope of PIE Proceedings

Section 40.379 of the NPRM proposed

that a PIE would apply to all the

divisions, organizational elements, and

types of services provided by the service

agent involved, unless the Director

limited the scope of the proceeding.

Under some circumstances, affiliates

and individuals could also be subject to

a PIE. Many service agent commenters

thought the scope of a PIE should be

narrower, limited to a particular type of

activity, affected employer, etc.

The intent of the PIE proposal is to

protect the public from the misconduct

of an organization. Allowing the

organization to segment its activities,

and contend that the public should be

protected only from some of what it

does, is contrary to this objective.

Nevertheless, the Department believes

that it is appropriate to decide, on a

case-by-case basis, whether a

compliance problem is limited to one

facet of a service agent’s activities or

pervades the service agent’s

organization. The Department is

therefore making a procedural change

from the NPRM. Instead of saying that

a PIE would apply to everything a

service agent does, the final rule makes

the scope of the PIE an issue in the

proceeding.

That is, the initiating official would

propose a scope for the proposed PIE,

depending on that official’s view of how

pervasive the noncompliance was in the

service agent’s organization. It might be

one activity or organizational element; it

might be more than one; it might be the

totality of the service agent’s activities.

The service agent could contest the

initiating official’s scope proposal, and

the Director would make an explicit

decision about scope. This is not quite

the ‘‘slice of pie’’ proposal advanced by

some service agents, since the

Department would not necessarily be

limited by rule to applying a PIE only

to the type of activity or organizational

element directly involved in the

noncompliance. But the initiating

official would have the burden of

persuading the Director that the

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79469

proposed scope of the PIE was

appropriate in light of the facts of the

case. The final rule text provides several

examples to illustrate the way this scope

procedure is intended to work.

6. Procedural Issues

Like the NPRM, the final rule requires

initiating officials to send a correction

notice to a service agent before starting

a PIE proceeding. This notice gives the

service agent 60 days to fix a problem

or change its procedures before a more

adversarial process begins. We have

added greater specificity concerning the

NOPE that begins a PIE proceeding (e.g.,

specifically requiring information on the

proposed scope and duration of the

PIE).

We believe that the ODAPC Director

is the appropriate person to make

decisions in PIE cases. The ODAPC

Director is someone who is

knowledgeable about the DOT program

and regulations but who is not directly

involved in their enforcement by the

DOT agencies. We disagree with

contentions that the Director is

inherently biased in potential PIE

matters. It is the Director’s job to

consider such matters fairly and in

accordance with the Department’s rules,

and nothing in the comments persuades

us that the Director will be unable to do

the job right.

To reassure participants further about

the objectivity of the process, we have

added language to the final rule

specifically prohibiting the ODAPC

Director from playing any role in the

initiation of a PIE and establishing a

‘‘firewall’’ between the initiating official

and the Director. This firewall would

prohibit any ex parte contacts between

the two. In any situation in which it

would be inappropriate for the Director

to act as the decisionmaker (e.g., the

Director had recent professional ties to

the service agent who was the subject of

the PIE proceeding, the Director has had

substantial involvement in a matter

before it becomes the subject of a PIE

proceeding), the rule the Director would

designate another person to decide the

case. In addition, the final rule lists the

elements of the Director’s decision,

including not only the basic decision

about whether to issue a PIE but also

decisions about disputed matters of

material fact, the scope of a PIE, and the

duration of a PIE.

The standard of proof in a PIE

proceeding will remain ‘‘the

preponderance of the evidence.’’ There

is no policy or legal basis apparent for

raising this burden to the higher ‘‘clear

and convincing evidence’’ level.

Contrary to a few comments, there is no

‘‘presumption of guilt’’ on the part of a

service agent in a PIE proceeding. The

initiating official bears the burden of

proof. Administrative proceedings in

many kinds of matters, including

suspension and debarment proceedings

under Part 29, are conducted informally,

without formal rules of evidence of the

kind used in the court system, with

evidence accepted on a general

relevance standard. The final rule makes

clear that PIE proceedings will be

conducted in this way.

The Department takes no position on

whether Part 40 creates a private right

of action, deferring to the courts or to

DOT agency regulations on this issue.

While the Department recognizes that a

PIE will have adverse consequences for

a service agent, we continue to believe

that the purpose of a PIE is to protect

the public interest, not punishment.

This language, which is derived from

Part 29, is an accurate statement of the

intent of the PIE provision and we are

retaining it. A few commenters asked for

a time frame for PIE decisions by the

Department. We have responded by

saying that the Director will generally

make a decision within 60 days of the

completion of the record in the case,

though the Director can extend this

period for good cause.

Some commenters requested

additional clarification of the standards

for determining the duration of a PIE. In

response, we have added a new section

listing examples of the kinds of factors

that the Director will consider in

determining the appropriateness, scope,

and duration of a PIE. Since the

proposed duration of a PIE is one of the

elements of a proceeding that service

agents can contest, service agents and

initiating officials will have the

opportunity to refer to these factors in

their arguments about duration. In

general, we say in the final regulatory

text that a PIE stays in effect for one to

five years. In deciding on the duration

of a PIE, the Director will take into

account the seriousness of the

noncompliance and other factors listed

in the rule. Nine months after the

Director issues a PIE, the service agent

can apply to the Director in writing to

terminate or reduce a PIE. The rule

spells out the grounds for such a

request.

As noted in the Effective Dates

section of the preamble, the Department

is making the PIE provisions of the rule

30 days from the date of publication.

The effect of this action is to make PIE

proceedings available to the Department

with respect to noncompliance with the

existing Part 40 rule between the

publication date of this revision and the

August 1 effective date of the complete

revised Part 40. We are doing so in order

to emphasize to service agents that they

are accountable for their actions. In

some recent instances (e.g., the apparent

laboratory evidence tampering incident

referred to in ‘‘Basic Rationale for PIE

Provisions’’ above), the Department

would have had grounds for considering

the use of PIE proceedings, had they

been available to us.

Return-to-Duty Process

The NPRM raised a number of issues

surrounding the return-to-duty process.

We proposed to consolidate this

material in Part 40. One issue concerned

the minimum number of follow-up tests

that SAPs should prescribe. Should

there be an increase over the current

rule’s requirement of six tests over the

first 12 months following an employee’s

return to duty (e.g., to 12 tests over one

or two years)? Another issue was

‘‘aftercare.’’ That is, SAPs often make

recommendations for continuing

assistance after the employee returns to

work. The NPRM proposed that

employers would have to monitor

employees’ compliance with these

recommendations. A third issue was

whether SAPs should routinely receive

drug test quantitations.

Comments

Comments from a mixture of

employers, employees, and service

agents directly addressed the question

of whether the Department should

increase the minimum number of

follow-up tests. A substantial majority

of these commenters opposed any

change in the current requirement of a

minimum of six tests over the first year

following the employee’s return to duty,

and a few of these suggested reducing

that minimum. These commenters did

not oppose retaining the SAP’s

discretion to prescribe a higher number

of tests or testing that went beyond the

first year. Some additional commenters

said that number of tests should be

determined at the SAP’s discretion, or

in negotiation between the SAP and

employer. On the other hand, a few

commenters favored increasing the

minimum to 12 tests.

With respect to aftercare, several

motor carriers and motor carrier

associations opposed the proposal for

employers to monitor employee

compliance with SAP

recommendations. They said it would

be too burdensome and went beyond

their expertise, which centered on

running trucks, not aftercare. A few

service agents supported the proposed

change. There was also concern

expressed, principally in discussions at

the listening sessions, that some SAPs

were reluctant to recommend assistance

79470 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

even after employees tested positive,

whether out of over-reliance on

employee’s excuses, claims that the

testing process was flawed, or the SAP’s

personal opinions about the justification

for or utility of the testing process. Some

commenters asserted that the very fact

of a violation showed that an individual

was in need of some education or

treatment, so it was inconsistent with

the purpose of the rules to permit SAPs

to find that an individual was not in

need of assistance.

Commenters were divided on the

issue of whether SAPs should routinely

receive reports of the quantitation of

drugs in the specimens of individuals

who tested positive. Those who favored

this approach, including most of the

employers who spoke to this issue and

some of the SAPs, said that it would be

useful to know the levels of drugs in the

employees’ specimens. This would be

helpful to SAPs as they try to evaluate

an employee’s situation and determine

what sort of treatment was appropriate.

The majority of commenters opposed

providing this information on a routine

basis, saying that the quantitation of

drugs in a specimen was usually

irrelevant to evaluation and treatment

and could sometimes be diagnostically

misleading. Testing was never intended

to diagnose addiction, and urine test

quantitations rarely provide a good basis

for evaluating an employee’s drug

problems. A laboratory added that

requiring laboratories to report this

information to SAPs would be

burdensome.

DOT Response

With respect to follow-up tests, the

Department has decided that it is not

necessary to increase the minimum

number. We believe that follow-up tests

are very important. They are the best

tool we have to make sure that an

individual who has returned to duty

after a violation remains in compliance

while experiencing the actual stresses

and temptations of the work

environment. However, requiring a

greater number of tests could be

unnecessarily burdensome in those

cases in which SAPs are satisfied that

six tests are sufficient. We will keep in

place the basic provisions of the existing

rule: a minimum of six such tests in the

first year of safety-sensitive work

following the employee’s return to duty.

SAPs will continue to have discretion to

require a greater number of tests over a

period of up to 60 months, as in the

current rule.

The Department has become

convinced that there is no basis for a

SAP ever determining that an individual

who has tested positive or otherwise

violated the drug and alcohol rules does

not need education or treatment as well

as follow up testing. For someone who

performs safety-sensitive transportation

functions, the very fact of a violation

indicates a disregard of safety that must

be addressed, corrected, and monitored

in order to ensure safe performance of

those functions in the future. Therefore,

the final rule will require the SAP to

mandate some level of assistance in

every case, as well as to prescribe at

least the minimum number of follow-up

tests for each employee who returns to

duty following any violation of the

rules. We also clarify that the SAP must

present a copy of his or her written

follow-up testing plan to the designated

employer representative (DER). The rule

text also cautions SAPs against basing

any decisions, even in part, on

employee claims of flaws in the testing

process or any private opinions of the

SAP about the validity or utility of the

testing process.

In response to comments, the

regulation clarifies that the follow-up

testing requirement follows the

employee from one job to another and

persists through a break in service. That

is, if after returning to duty with an

employer, the employee changes jobs

before completing all required follow-up

tests, the employee is responsible for

completing the follow-up tests with his

or her new employer. Likewise, if the

employee returns to work, is laid off for

several months, and then comes back to

work with the same employer, the

employee must complete the series of

follow-up tests ordered by the SAP.

With respect to employer monitoring

of aftercare, the Department is

persuaded by the objections of employer

commenters that we should not require

employers to take on this task. SAPs

have the obligation to make

recommendations for aftercare where

they believe such assistance is needed

to maintain sobriety or abstinence from

illegal drugs. These recommendations

should carry a good deal of weight,

because they in effect declare that

employee compliance with them is

important to ensure safe performance of

safety-sensitive functions. The rule

states the employee’s obligation to

comply with these recommendations.

Rather than requiring employer

monitoring, however, the rule provides

the employer discretion to take a variety

of steps. These could include putting

compliance with SAP recommendations

into return-to-duty agreements,

disciplining employees for

noncompliance, and using the services

of SAPs or employee assistance

programs (EAPs) to assist and monitor

employees’ aftercare activities. The rule

notes that employers can choose to

monitor these activities, and that

employees who fail to carry out the

recommendations can be subject to

sanctions from their employers. We note

that this discussion concerns employer

discretion with respect to aftercare (e.g.,

treatment and education) activities only.

Employers do not have discretion with

respect to follow-up tests. Employers

must carry out the follow-up test

instructions they receive from SAPs.

The Department believes that the

commenters who opposed routinely

providing drug test quantitations to

SAPs have the better of the argument.

SAPs take a variety of factors—

including a face-to-face interview with

the employee—into account when

determining what assistance the

employee needs. The amount of a

particular drug in an employee’s

specimen at a particular time does not

determine what sort of treatment is most

appropriate for the individual.

Consequently, we will not provide for

quantitations to be given to SAPs on a

routine basis. We do provide, however,

that SAPs can consult with MROs (who

must cooperate with SAPs) and receive

information that the MRO has gathered

as part of the verification process.

Through this process, SAPs can get

additional information that may be of

use to them in the evaluation process.

We want to emphasize that neither

the rule nor the Department requires

employers to fire employees who violate

the Department’s drug and alcohol

testing rules. There is no national

policy, and certainly no policy

articulated by the Federal government,

that commands this result. We would

not have this detailed return-to-duty

procedure if we believed that no one

should be returned to duty after a

violation.

As has been true from the beginning,

all the Department requires is that an

employee who violates the rule not

perform safety-sensitive functions until

and unless he or she successfully

completes the return-to-duty process.

Decisions about discipline and

termination are left to the discretion of

the employer or labor-management

negotiations. Where employer policy, or

labor-management negotiations, have

delegated personnel decisions of this

kind to an arbitrator, the Department

intends that the arbitrator’s decision

determines the personnel action that the

employer takes. The Supreme Court has

recently affirmed these principles.

Eastern Associated Coal Corporation v.

United Mine Workers of America,

District 17, et. al, 531 U.S. ll (2000).

Of course, an arbitrator cannot order

an employer to return an employee to

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79471

the performance of safety-sensitive

functions until the employee has

successfully completed the return-toduty process. Nor can an arbitrator or an

employer change the laboratory’s

findings about a specimen or an MRO’s

decision about whether there is a

legitimate medical explanation for a test

result.

Collector Training

Competent performance of drug and

alcohol testing functions by collectors,

BATs and STTs, MROs, SAPs and

others involved in the testing process is

obviously very important to the integrity

and fairness of the Department’s

program. The Department’s NPRM

asked questions and offered proposals

for the training and qualifications of

these personnel. This discussion focuses

on collector training, which was the

subject of more comment than training

for other personnel. Training and

qualifications for other personnel are

discussed in the section-by-section

portion of the preamble.

Comments

Training for collectors in the drug

testing program was the subject of

comment from a wide variety of parties,

including service agents, employers,

and unions. Commenters differed on

most of the subjects under discussion,

including the basic point of the extent

of current problems in the collection

area. Most commenters on the subject

believed that collections were the

weakest point of the testing process,

though some argued that there was a

low rate of collection errors in their

experience. Some commenters said that

it would reduce collection errors if the

Federal Custody and Control Form

(CCF) were simplified.

Some commenters favored a formal

instruction course for collectors, like the

Department’s BAT course. Most of these

and some other commenters opposed

the notions of self-instruction and selfcertification for collectors, saying that

they were meaningless. They believed

that there should be some sort of formal

training, with an examination or other

means of ensuring that a collector

deserved to be certified. Some

commenters also supported a ‘‘train-thetrainer’’ course requirement to certify

trainers.

Other commenters, however, opposed

any formal training requirements for

collectors, saying it was expensive,

burdensome, and might make it harder

to find collectors, especially in less

densely populated areas. A maritime

employer group asked for some

exceptions to training requirements for

people who were not regularly

collectors but might occasionally have

to conduct a collection, as in a postaccident situation.

Commenters who thought the NPRM’s

training proposals were too extensive

often objected to requirements for

classroom training or other training

modes involving a live instructor or

monitor. They said the requirements

should be more flexible, and provide for

training through such approaches as

videos, internet-based courses, or

instruction and monitoring through

telephone or interactive computer

methods.

A number of commenters objected to

the term ‘‘sufficiently knowledgeable,’’

which the NPRM used to describe the

personnel who trained collectors. The

commenters said the term was too

vague. Some of these commenters asked

that the rule include more specific

qualifications for trainers. Some

commenters also objected to the

proposal that trainees be required to

complete five error-free mock

collections, saying that the requirement

was either too burdensome (some

suggested the number of mock

collections be reduced) or insufficient.

Some commenters also took issue with

the requirement that a collector who

made a ‘‘fatal flaw’’ mistake should have

to be retrained, particularly since they

felt it might threaten the validity of

subsequent collections the collector

conducted prior to the retraining. Others

thought it would be better to have a

slower trigger for the retraining

requirement (e.g., two fatal flaws in two

years).

DOT Response

The Department believes that making

collector training more effective will be

an important step in reducing errors in

the drug testing process. The collection

of urine specimens is the step in the

process with the greatest potential for

administrative error, and our own

experience confirms the comments of

persons who said that collections are a

fertile source of mistakes. When our

inspectors and program personnel visit

collection sites in the field, they

commonly find a wide variety of

mistakes and misunderstandings in the

collection process. We also agree that

self-certification is inadequate. For these

reasons, we will require additional

training of collectors, compared to the

present rule. We believe that this

training should be provided in as

flexible a manner as possible. Section

40.33 contains the Department’s

resolution of collector training issues.

Part 40 contains much information

about how collections must be

conducted. It is essential that collectors

become knowledgeable about the

relevant portions of the new Part 40,

DOT collections guidance and relevant

DOT agency rule provisions, and we

will require them to do so. We also

believe that more formal training is

needed to ensure that collectors

understand and can carry out the

requirements of this part. We believe

that, as commenters noted, the training

can be provided in a number of ways

(e.g., classroom sessions, videos,

internet courses). We are not prescribing

a particular curriculum as we have for

alcohol testing personnel, and we will

not require that collectors be ‘‘certified.’’

By taking this approach, we achieve the

objective of additional training while

allowing flexibility and minimizing

costs. In-person involvement of a trainer

is not required for this part of the

training process.

To demonstrate that they can

practically apply what they have

learned, collectors must conduct five

consecutive error-free mock collections.

We believe this is an extremely

important requirement, because

collectors must deal with real people

and real specimens in their job, not just

regulatory text or computer simulations.

By mock collections, we mean

collections that are not real collections

of employees subject to testing under

DOT regulations. The five collections

must include both uneventful and

‘‘problem’’ testing scenarios. Another

person must monitor and evaluate the

mock collections to ensure that they are

error-free. This part of the process does

involve the in-person participation of

someone to monitor and evaluate the

trainee’s performance (unless some

technology is used that permits the realtime, step-by-step observation and

evaluation of the trainee’s performance

without a person in the same room with

the trainee).

The monitor must be someone who

has demonstrated necessary knowledge,

skills, and experience (1) by regularly

conducting DOT drug test collections

for a period of at least a year, (2) by

having conducted collector training

under this part for a year, or (3) by

successfully having completed a ‘‘trainthe-trainer’’ course. The Department sets

out these alternatives for qualifying as a

trainer in response to comments that

said ‘‘sufficiently knowledgeable’’ was

too vague.

All new collectors must meet these

training requirements. In addition,

current collectors must meet the

requirement within 21⁄2 years after the

effective date of this rule (December

2003). This will provide adequate time

for current collectors to get the

79472 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

necessary qualification training, if they

have not already done so.

Collectors would have to get refresher

training every five years. We believe

that, just as other professionals in the

drug and alcohol testing business need

continuing education, it is important for

collectors to brush up on the rules and

techniques of their part of the drug

testing process, in order to ensure that

they perform at the highest level. This

training would also focus on any

changes in collection technology that

had come into use in the meantime.

One of the most important occasions

for training is following a mistake that

actually results in a test being cancelled.

This requirement does not apply every

time there is a cancelled test, only when

the cancellation is the result of the

collector’s error. The training would

focus on the subject matter that was

involved with the error, and would also

involve three monitored error-free mock

collections. This training would have to

take place within 30 days of the

collector’s being notified of the error.

The reason for this training is obvious:

if someone makes a mistake once, we

want to make sure he or she does not

make a similar mistake again.

Commenters noted that it might be

very burdensome for employers, or even

some service agents, to keep training

records for each of their possible many

and widespread collectors. To avoid this

problem, we are requiring that collectors

(like other service providers) keep their

own training records, which would have

to be made available to employers, other

service agents (e.g., C/TPAs) involved

with the collector’s provision of

services, and DOT. In addition, we

specify in § 40.209 that a test is not

invalidated because a collector has not

fulfilled a training requirement. For

example, suppose someone collects a

specimen correctly but has not

completed required training or

retraining. The test would not be

cancelled because the training

requirement was not met, though the

collector, other service agents, and

employer involved might be found in

noncompliance as the result of the

failure to meet training requirements.

Transmission of Information Through

Consortia and Third-Party

Administrators

When the Department began the drug

testing program in 1988–89, we had in

mind a perhaps simplistic model of how

the program would work. We imagined

that most employers would have an inhouse testing program that would

perform most of the tasks the rules

required, except that employers would

contract directly with laboratories for

specimen testing services and perhaps

with MROs for medical review services.

We thought that owner-operators and

other very small employers might well

band together in consortia to gain

economies of scale in purchasing

testing-related services.

The program has developed in quite

different directions, to the point where

most employers’ drug and alcohol

testing programs are outsourced, often

operated by C/TPAs. These

organizations often bundle their services

to employers. Only a minority of

employers, usually large ones, operate

their own programs.

One of the Department’s tasks in

revising Part 40 is to make appropriate

adaptations to the altered shape of the

drug and alcohol testing business. We

have no desire to stand as King Canute

before the marketplace sea. Nor do we

wish to surrender to purely economic

considerations features of the program

we regard as critical to its integrity. The

goal of finding an appropriate balance

has influenced our efforts in a number

of areas as part of this rulemaking,

including the functions of MROs and

SAPs and the issue of how test results

are reported to employers.

In the NPRM, the Department

proposed keeping sharp lines of

demarcation between different

participants in the program.

Specifically, we proposed putting into

regulatory text the interpretation we

have maintained under the existing rule

with respect to the transmission of drug

test results from MROs to employers.

That is, MROs must report the results

directly to employers. C/TPAs could not

act as intermediaries in this process.

This position was based on the premise

that indirect reporting was likely to be

slower, and more prone to error and

compromise of confidentiality, than

direct reporting.

Comments

The bulk of comments on this issue

came from TPAs, who asserted that they

should be permitted to act as

intermediaries in the transmission of

drug testing results. There were also

comments from employers and unions,

most of which supported the TPAs’

position. During discussions of this

issue in the listening sessions, DOT staff

asked TPAs to address the question of

how it was as or more efficient and

effective to move a result from Point A

(the MRO) to point B (the employer)

through Point C (a TPA), rather than

sending it directly from Point A to Point

B. Many of the C/TPA comments did

address this question.

A common response was that many

MROs do not have the staff or electronic

capability to receive, process, and

transmit results to clients. Indeed, many

smaller doctors’ offices would find it

burdensome to handle all the

paperwork. It is more efficient division

of labor to have doctors concentrating

on medical review and TPAs on

information distribution, some said.

TPAs, commenters said, are set up to act

as electronic transfer points for data,

allowing for the more efficient and

timely delivery of results. Requiring the

MRO to transmit the results directly

would increase rather than decrease

processing time and add costs.

Commenters favoring change in this

proposal also said that TPAs know the

rules and regulations well, since this is

their full-time business. Small

employers find it easier to call one

place—the TPA—for all drug program

information rather than having to deal

with a variety of sources. Some of these

commenters noted that, in the Coast

Guard program, TPAs had played this

role successfully for some time. They

said there was no evidence of any

detriment to public safety in this case,

or in other cases where TPAs (contrary

to existing rules) have transmitted

results.

Some MROs and TPAs disagreed with

this point of view, citing concerns about

delays, administrative errors, and risks

to confidentiality. Commenters said that

many MROs are fully capable of

transmitting results information directly

to employers, and that if an employer

found that it was not receiving results

in a timely fashion, it could change

MROs. In addition, direct MRO

transmission may provide greater value

to employers, because MROs can answer

questions about the result and help the

employer resolve procedural issues.

Comment on this issue focused on

MRO transmission of verified drug

testing results to employers. However,

many commenters mentioned other

areas in which similar issues arise, such

as laboratory transmission of results to

MROs, transmission of SAP reports to

employers, and transmission of alcohol

test results from BATs to employers.

A related, but distinct, issue

concerned who could appropriately

play the role of the designated employer

representative (DER). Some commenters

said that C/TPAs should be able to act

for employers as DERs, at least in small

companies. Some of these comments

alleged that the role of the DER was a

complex, multifaceted one, and that it

would be very costly, particularly for

small companies, to hire a DER.

DOT Response

The Department is persuaded by the

comments on this subject that C/TPAs

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79473

have the ability to transmit verified drug

test results to employers as or more

efficiently than MROs who transmit the

information directly. While we

understand, and to an extent share,

concerns about potential delays, errors,

and breaches of confidentiality when

intermediaries are used, we do not have

any evidence in the record that these

problems actually occur in any

significant way. The Coast Guard

experience, as reported by commenters

(including some employer and union

commenters) and verified by Coast

Guard staff, suggests that the parties

concerned in that industry are satisfied

with this approach.

Consequently, the final rule (see

—40.345) gives employers the choice of

receiving drug test results directly from

the MRO or via a C/TPA. We emphasize

that it is up to the employer—not the C/

TPA—to make this choice. The

employer can make this choice for any

or all of the items listed in Appendix F

(e.g., an employer may choose to receive

some items via the TPA and others

directly from an MRO). The rule

authorizes C/TPAs to act as

intermediaries in the transmittal of

information to employers only with

respect to the specific provisions of the

rule listed in Appendix F. C/TPAs are

prohibited from acting as an

intermediary in transmitting

information not listed in Appendix F.

For example, C/TPAs are not allowed

to act as an intermediary who transmits

laboratory test results to MROs , SAP

reports to employers, or medical

information from MROs to employers.

In the case of the laboratory reports, we

believe that the direct link between

laboratories and MROs is critical to the

timely and independent medical review

of those results. (Certainly laboratories

have the electronic capability to readily

transmit results directly to MROs in a

timely and accurate fashion.) With

respect to SAP reports, we are

concerned that using an intermediary

creates the opportunity and temptation

to alter the SAP’s recommendations (a

problem that DOT staff have noted in

the current program). With respect to

medical information, we believe this is

confidential medical data that should

not pass through an additional hand on

its way from the MRO to the employer.

The discussion of this issue among

commenters focused mainly, though not

exclusively, on drug test information. A

few commenters mentioned that similar

considerations should apply to alcohol

testing information. With respect to

‘‘negative’’ alcohol test results (i.e.,

results of less than 0.02), we agree. The

same rationale that supports permitting

drug testing information to be conveyed

by C/TPAs applies to this information.

However, we draw a distinction with

respect to alcohol testing results of 0.02

or higher. These results—unlike positive

drug test results or negative drug or

alcohol test results—mean that an

employee is, to some extent, impaired

by alcohol. As a safety matter, the

employer must immediately remove the

employee from performance of safetysensitive functions. This is a situation

where time is of the essence, and we

therefore will continue to require BATs

to transmit these results directly to

employers. C/TPAs are not authorized

to act as an intermediary in this

situation.

We believe that it is essential that

someone employed by the actual

transportation employer act as the DER.

The DER’s function is to receive

information about certain kinds of test

results and take required action, such as

removing an employee from the

performance of safety-sensitive

functions. Someone who is an employee

of a C/TPA, rather than of the actual

transportation employer, is less well

situated to perform these functions,

especially since a C/TPA representative

generally does not have line authority

over a transportation employer’s

employees.

Much of the comment on this issue

appears based on a significant

misunderstanding of the role of a DER.

A DER is not a drug and alcohol

program manager. A DER does not need

extensive knowledge about the DOT

drug and alcohol testing program and

need not spend extensive time on DER

duties. The DER is simply someone who

can act immediately to remove an

employee from safety-sensitive

functions, or take other appropriate

action, upon receipt of information that

the employee has violated the rules or

needs to be subject to certain testing

requirements. Particularly for small

companies (e.g., a 3-10 driver trucking

company), the DER is likely to perform

this function on a collateral duty basis,

fielding a rare phone call (i.e., there are

not many tests per year and only a small

percentage of tests result in violations)

and removing an employee from safetysensitive functions on those occasions.

This is not a time-or resources-intensive

activity, and it would certainly not

require hiring an extra human resources

staff person.

The one exception the final rule

makes concerns owner-operators. Under

the FMCSA rule, owner-operators are, in

effect, required to get at least random

testing services through a C/TPA. In an

owner-operator, the driver is his or her

own boss, so there is no one else in his

or her own organization to direct him or

her to stop performing safety-sensitive

functions. In this situation, we think it

is probably better to permit the C/TPA

to perform what otherwise would be a

DER function.

Collection Process Issues

Commenters were interested in a

variety of issues in the drug testing

collection process. These included

dilution issues, the consequences of

refusing to drink fluids and the length

of the interval before the second

collection attempt in ‘‘shy bladder’’

situations, retests under direct

observation when a split specimen is

unavailable for testing, using split

specimen collections in all DOT modes,

and having employees remove boots as

part of the preparation for a collection.

Comments

The first issue in this category is

whether, when there is a specimen that

is both negative and dilute, there should

be an immediate recollection under

direct observation. Commenters took a

number of positions on the issue. Some

employers and service agents favored

making retests under direct observation

mandatory, on the ground that a dilute

specimen effectively formed a basis for

a reasonable suspicion that the

employee had tried to conceal drug use.

Some unions and service agents

opposed such a requirement because it

would intrude on employees’ privacy,

might well result from innocent

consumption of water, and was of

dubious value in deterring and detecting

illegal drug use.

A plurality of commenters favored

making a recollection, as well as the

decision about whether to use direct

observation, optional with the

employer. This approach, they said,

would recognize the variety of

situations in which a dilute specimen

may occur. It could be done in

consultation with MROs, to ensure that

there was some medical input into the

employer’s decision.

The second, related issue is whether

an employer should be able to disregard

a negative dilute result. For example,

suppose an employer receives such a

result on an applicant’s pre-employment

test. Should the employer be able to

require the applicant to take another test

to get a ‘‘real negative’’ before beginning

safety-sensitive work? Most employers,

and some service agents, who

commented on this issue favored this

approach, especially in pre-employment

testing. They did so in the belief that a

negative dilute result was, at best,

questionable. Even if it did not result

from a deliberate attempt to cheat on a

test, it was not as definite a

79474 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

demonstration of compliance as a

negative test from a more concentrated

specimen. Unions and some service

agents disagreed, saying that this would

unnecessarily burden employees,

including many who could achieve

dilute (as distinct from substituted)

results naturally, by drinking a lot of

water (which some commenters made a

point of noting was a legal substance).

This approach would involve a ‘‘guilty

until proved innocent’’ approach, in this

view.

Most, though not all, employers said

that an employee who refuses to drink

additional liquids after failing in his or

her initial attempt to produce a

sufficient specimen should be regarded

as having refused to test. These

commenters saw refusals to drink as

attempts by employees who had used

drugs to avoid a positive test. They also

viewed it as a waste of up to three hours

of time that the employee remained off

the job (but presumably in paid status).

Some service agents also shared this

point of view. Unions and other service

agents disagreed. They said that an

employee could have legitimate health

or other reasons for not wanting to drink

additional fluids. Moreover, if an

employee fails to drink fluids, and

consequently fails to produce a

sufficient specimen on the second try,

the employee will be referred to a

physician for an evaluation. If the

physician does not find that a medical

condition produced, or could have

produced, the inability to provide a

sufficient specimen, the employee will

be treated as having refused the test.

This consequence is sufficient, these

commenters said.

When an employee has a verified

positive test, the Omnibus Employee

Testing Act gives the employee the right

to request a test of the split specimen.

The Department has long taken the

position that if the employee makes a

timely request to test the split specimen,

and the split specimen is unavailable for

testing (e.g., the split specimen was

never collected, leaked away, or was

lost), the test must be cancelled. While

we believe this outcome is necessary as

a matter of law, it raises a safety

concern. In such cases, we have an

apparently valid, verified positive

result, indicating that the employee

used illegal drugs. However, because of

the accidental unavailability of the split

specimen, the employee can continue to

perform safety-sensitive functions.

In response to this concern, the NPRM

sought comment on the idea of requiring

a recollection under direct observation

in these cases. This might detect drug

use by the employee and result in his or

her removal from the performance of

safety-sensitive functions. The rationale

for the direct observation aspect of the

procedure reflects the belief that an

employee, having recently tested

positive, may have an additional

incentive to cheat on the second test.

Comment was divided on this issue.

Employers generally supported the

proposal to require recollection under

direct observation on the safety

rationale mentioned above. Unions and

some service agents opposed the

proposal, saying that it undermined the

employee’s right to a test of the split

specimen. Some added that the second

test would not really answer the

question of whether the employee has

tested positive on the first test.

Opponents of the proposal particularly

objected to the direct observation aspect

of it, on intrusiveness and violation of

privacy grounds. Why, they asked,

should someone suffer a directly

observed test because the collector made

an error?

Currently, those DOT agencies

covered by the Omnibus Transportation

Employee Testing Act—FRA, FAA,

FTA, and FMCSA—are required to

collect split specimens. RSPA and Coast

Guard, whom the Act does not cover,

give employers the choice of collecting

single or split specimens. Commenters

on this point almost unanimously

favored requiring split specimens in all

DOT agency programs. They said that

this would be much simpler and less

confusing, and likely would reduce the

incidence of errors (e.g., failure to

collect split specimens where required).

Split specimen collections are not any

more expensive than single specimens,

one commenter said. One commenter

questioned the Department’s authority

to require split specimen testing in

RSPA and the Coast Guard absent

legislation.

The Department has heard concerns,

over the years, that some employees

have concealed adulterants or other

means of tampering with tests in their

boots (e.g., cowboy boots). For this

reason, the NPRM proposed that

collectors would ask employees to

remove their boots, so that collectors

could check them for such items.

Commenters almost unanimously

panned this proposal, asserting that it

was intrusive, ineffective, and

inconsistent (i.e., vis a vis the rule’s

treatment of other footwear and

clothing). Commenters raised specters

ranging from confrontations between

employees and collectors to exposing

collectors to unpleasant foot odors.

DOT Response

With respect to the issue of negative

dilute tests, the Department has decided

to give employers discretion about how

to handle these situations (see

—40.197). There are reasonable

arguments on both sides of this

question, and the Department is not

persuaded that that there is a single,

across-the-board, right answer. The

variety of circumstances among

employers appears too wide to permit a

unitary solution. In response to

concerns about recollections being

unduly burdensome on employees, the

Department will require that a given

employer treat all employees equally, to

avoid the possibility of arbitrary

selections of individuals for

recollection. That is, an employer would

have to treat all situations in a given

category the same way (e.g., require

recollections in all pre-employment test

situations that had negative dilute

results). This would prevent employers

from singling out disfavored employees.

In addition, employers would be limited

to a total of two tests (the original

negative dilute result and one

recollection). They could not conduct

additional tests if the recollection were

also a negative dilute, for example. This

provision limits the potential burden on

employees.

If an employer chooses to conduct

another test, it could not be conducted

under direct observation, unless one of

the other circumstances permitting or

requiring direct observation occurred.

We use direct observation primarily to

counter the likelihood of tampering at

the collection site. This makes sense in

situations where we are mostly

concerned about adulteration or

substitution. Most dilution cases,

however, arise because an individual

hydrates his or her system before going

to the collection site. Privacy issues

aside, then, direct observation seems off

point in the dilution situation. What is

useful is giving an employee the

shortest possible interval between

notice of the test and the conduct of the

test, so that the individual does not have

time to overhydrate. For this reason, the

rule requires employers to provide no

advance notice of the recollection to

employees.

The Department will not include any

general provision requiring or

authorizing employers to disregard the

results of negative dilute tests. Given the

structure of the rule, such a provision is

unnecessary. Employers have the

discretion to conduct one recollection

following a negative dilute result. If the

employer chooses not to conduct a

recollection, then the negative result is

the only result it has, and the employer

will rely on the result just as is does in

any other case. If the employer does

conduct a recollection, then the result of

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79475

the recollection—not the original test—

becomes the result on which the

employer relies for all purposes. The

original test would be cancelled in this

situation, and not reported for

management information system (MIS)

purposes.

The bottom line in any ‘‘shy bladder’’

situation is that, if, by the end of the

collection process, the employee has not

produced a sufficient specimen, the

employee must be evaluated by a

physician. Unless the physician finds

that a medical condition resulted, or

could have resulted, in the inability to

provide a sufficient specimen, the

employee is regarded as having refused

to test (see —40.193). Given this

provision, we believe it is unnecessary

to say that a refusal to drink fluids,

standing alone, is a refusal to test.

As some commenters said, there may

be legitimate reasons for an employee’s

decision not to drink fluids in this

situation. In any case, if the employee

declines to drink, subsequently does not

produce a sufficient specimen, and

cannot establish a medical condition

explaining his or her inability to

provide the specimen, a refusal to test

will be established. While having

employees waiting in a collection site

for three hours, with or without

drinking, may annoy employers and

collectors, we do not believe this is a

sufficient reason to terminate the shy

bladder process because the employee

does not choose to drink during that

period.

We believe that there is a strong safety

rationale for requiring a recollection

under direct observation following a

verified positive, adulterated, or

substituted test that is cancelled because

the split specimen is unavailable for

testing. In this situation, we know that

there were drugs or an adulterant in, or

substitution of, the primary specimen,

and that there was no legitimate medical

explanation. Split specimens fail to

reconfirm the result of the test of the

primary specimen in only a tiny

minority of cases. If we do not collect

another specimen in this case, there is

a very high probability that we will be

permitting an employee who has used

illegal drugs, or tried to tamper with a

test, to continue performing safetysensitive functions. That is a significant

safety concern.

By recollecting another specimen, we

have some possibility of detecting

continuing drug use. Knowing that

recollections will occur in this situation

may also have some deterrent effect on

employees. By recollecting another

specimen under direct observation, we

can limit the opportunities for

tampering, for which there is a

heightened incentive in this situation.

We do not view this provision as

penalizing an employee because a

laboratory or collector erred. Rather, in

the face of a laboratory or collector

error, we view this provision as closing

an inappropriate loophole for an

employee who appears to have used

illegal drugs or tried to defeat a test.

We agree with commenters that it

makes much more sense for all DOT

agencies to have consistent

requirements concerning split

specimens. Therefore, Part 40 requires

all collections to be split specimen

collections, and RSPA and Coast Guard

will amend their rules accordingly. We

will delete from Part 40 all references to

single specimen collections. There is no

legal authority issue here: RSPA and

Coast Guard base their rules on their

statutory general safety authority, which

does not contain specific requirements

or prohibitions concerning how drug

specimens are collected. There is no

legal difference between these agencies

using their discretion in implementing

their general safety authorities by

requiring split specimen testing and

using it to give employers an option

between split specimen or single

specimen collections.

We are persuaded by commenters that

we should not go forward with the

proposal to have collectors remove and

inspect boots. The problems of this

approach likely outweigh the benefits.

Therefore, we have booted this

provision out of the final rule.

Information Release Issues

MROs sometimes find themselves in a

dilemma. They verify a positive test

result on an employee of Employer A.

They also know that the same employee

works in a DOT-regulated safetysensitive position for Employer B.

Consistent with safety and

confidentiality responsibilities, what

should the MRO do? The NPRM sought

comment on this issue. The NPRM also

asked for comment on whether MROs

and other parties (e.g., C/TPAs) should

report positive tests and other rule

violations to DOT operating agencies, so

that they could take enforcement action.

Comments

There was a variety of comment on

the idea of MROs sharing test

information with other employers.

Many employers, MROs, unions and

other parties opposed allowing MROs to

do so because it would breach employee

confidentiality. Given the large data

bases that some service agents maintain,

this breach could be very wide, some

commenters said. Some service agents

questioned whether the proposed rule’s

language would have the effect of

creating a duty on service agents to

conduct searches of such data bases.

Other MROs and employers favored

giving MROs this discretion, in order to

enhance safety and help MROs who find

themselves in this dilemma.

Commenters cited potential liability

concerns on both sides of the question.

Other commenters suggested that more

systematic approaches to this problem

might be more productive, such as

creating a national data base of persons

who had violated rules or requiring

employers hiring new workers to check

with previous employers about past test

results (as FMCSA’s rule already does).

Canadian commenters also mentioned a

concern that information release to third

parties without individual employee

consent may violate Canadian law.

Commenters addressed the issue of

release of information in legal

proceedings. The existing rule and the

NPRM focus on legal proceedings

brought by an employee (e.g., an unjust

termination suit). What about personal

injury cases in which the employee’s

test result is a relevant issue,

commenters asked.

Some commenters thought that

having service agents report rule

violations to the DOT agencies was a

good idea that would enhance safety.

For example, if an owner-operator fails

to show up for a test and continues to

drive, only the C/TPA may know of the

refusal. If the C/TPA does not report the

problem to FMCSA, the likelihood of

the owner-operator getting away with

his or her refusal is heightened. Others

raised confidentiality concerns and

thought that there could be problems if

service agents reported incomplete or

erroneous information to the DOT

agencies. Some service agents also

feared that if they had authority to

report violations to DOT agencies, even

if this were not mandatory under the

rule, they would be liable for not doing

so. Others thought that this would

create a difficult conflict of interest

situation for service agents.

DOT Response

The Department has decided to drop

the proposal to permit or require MROs

to pass on to third party employers

information about the results of tests the

employee took at the direction of

another employer. The Department

understands that confidentiality rules

sometimes place MROs in a difficult

position. Nevertheless, confidentiality is

a cornerstone of the balance between

safety and employee privacy that is

crucial to the acceptance and

constitutionality of the testing program.

The Department is also concerned that

79476 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

it would be very difficult to draft a

provision that solved the ‘‘doctor’s

dilemma’’ situation without opening the

floodgates to widespread searching of

large data bases for information on

employee testing records that could

severely compromise confidentiality.

We do not think our NPRM language

succeeded at this task. Consequently, as

under the current rule, MROs will be

prohibited from passing such

information on to third party employers

without the employee’s consent. As

described in the discussion of § 40.25,

we are adding a requirement to query

previous employers for drug and alcohol

test information in place of the

proposed provision, based on an

existing FMCSA provision.

Another alternative to the proposal

would be to create a Federal data base

that would include all test results,

which authorized employers could

search to learn authorized information

about current or prospective employees.

This is a significant issue, but not one

we are able to resolve at this time. We

do believe that, in order to be effective,

a data base of this sort would have to

be national in scope under Federal

supervision, rather than a mixture of

state, local, and private data bases. It

would also have to successfully solve

security, access, due process, and

updating issues. Creation of such a data

base remains a matter for further study.

The Department has decided to

broaden the scope of release of

information in the context of legal

proceedings. We have added a provision

(see § 40.323) that would permit

employers to release test information in

a criminal or civil court proceeding

resulting from an employee’s

performance of safety-sensitive duties, if

the court orders it. For example, in

personal injury litigation following a

truck or bus collision, the court could

determine that a post-accident drug test

result of an employee is relevant to

determining whether the driver or the

driver’s employer was negligent. The

employer would be authorized to

respond to the court’s order to produce

the records.

There would be limits on the use of

this information, however. The

employer could release the information

only to the decisionmaker, such as the

judge in a lawsuit. It could be released

only subject to a binding stipulation or

protective order that the decisionmaker

to whom it is released will make it

available only to the parties to the

proceeding, who could not disseminate

it further or use it for other purposes.

The Department believes that this

approach provides for relevant use of

test information without permitting the

information to be spread about too

widely. These limits also apply in

situations where the information is

made available in a proceeding brought

by the employee (e.g., a grievance,

arbitration, or lawsuit concerning

personnel action following a violation).

The Department has decided against

requiring service agents to report

apparent violations of the rules to the

DOT agencies. Service agents can do so

in any situation in which DOT agency

rules already permit them to do so. The

principal reason for this decision is that

the Department’s enforcement resources

are limited. The DOT agencies must take

great care in prioritizing the use of those

resources, so that the greatest safety

benefit is derived from their allocation.

Service Agent Contract Language

The NPRM proposed that every

contract or agreement between an

employer and a service agent would

have to include an assurance of

compliance with DOT rules. The

purpose of this proposal was to ensure

that the obligation to comply with Part

40 and other DOT rules was not only a

matter of regulation, but also a key part

of the contractual relationship among

participants in the testing program.

Comments

Some employers and unions favored

the proposed requirement, saying that it

would help them ensure that services

were provided properly. They said it

would create universally understood

contract remedies if service agents failed

to provide appropriate services. Most of

the commenters on this proposal were

service agents, and they almost

unanimously opposed the proposal.

They said it would add substantially to

the paperwork burden of the rule and

would add costs (e.g., for attorney

involvement in the contracting process).

Moreover, opponents said, there are

many times in which employers do not

have written contracts with some

service agents (e.g., collection sites

remote from the employer’s principal

place of business), so there is no

contract in which to incorporate such a

clause. Requiring written contracts

where none now exist would also be

unnecessarily burdensome, they said. A

mandatory contract clause could also

lead to litigation, some commenters

feared.

DOT Response

The purpose of the proposed

requirement was to ensure that

compliance by service agents with this

and other DOT rules was an enforceable

contractual responsibility. The

Department now believes that this

purpose can be achieved by other

means. We have replaced the proposed

written contract clause requirement

with a regulatory statement (see

§ 40.11(c)). It provides that all

agreements and arrangements, written

or unwritten, between employers and

service agents are deemed, as a matter

of law, to require compliance with all

applicable provisions of this part and

DOT agency drug and alcohol testing

regulations. The rule declares that

compliance with these provisions is a

material term of all such agreements and

arrangements. Combined with the PIE

provisions of Subpart R, this provision

ensures that when a service agent is in

noncompliance, DOT (through a PIE) or

an employer (through a contract action)

can respond effectively to service agent

noncompliance. These provisions will

achieve the Department’s objective

without incurring the paperwork burden

and other problems cited by

commenters with the NPRM provision.

We also did not want to create potential

compliance problems for service agents

and employers based on the lack of a

written agreement.

Electronic Technology Applications

The NPRM asked for comment on

how best to incorporate electronic

technology into the drug and alcohol

testing process to a greater extent.

Comments

A substantial majority of all

commenters on this issue strongly

supported the wider use of electronic

technology throughout the DOT drug

and alcohol testing program. The

suggested applications included such

things as electronic signatures by

various participants, an electronic CCF,

and electronic storage and transmission

of data. One of the goals mentioned in

some comments was the ‘‘paperless

lab.’’ Supporters emphasized the greater

speed and efficiency of these

applications, contrasted to a paperbased system. Some commenters noted

that electronic applications of this kind

were already in wide use in the private,

non-regulated sector of drug and alcohol

testing, and that the Food and Drug

Administration had approved the use of

electronic signatures in some contexts.

Commenters mentioned that, in order

to do the job right, electronic

applications had to ensure the integrity

and security of information, but many

commenters also said that appropriate

technological tools for this purpose

already existed. Some commenters

sounded cautionary notes, particularly

with respect to the Department being

assured of the effectiveness of system

safeguards and the forensic acceptability

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79477

of electronic records and signatures

before authorizing additional use of

electronic applications in the program.

DOT Response

The Department believes that the

increased use of electronic methods in

the program is both inevitable and

beneficial. At the same time, we want to

make sure that there are good,

consistent minimum standards for the

use of this technology, so that the

integrity and confidentiality

requirements of the program continue to

be met. For this reason, the Department,

in cooperation with HHS and the Office

and Management and Budget (OMB),

intend to form an advisory committee

under the Federal Advisory Committee

Act. Many of the interested parties

began meeting this past summer to

discuss the issues under the auspices of

an OMB information technology

initiative.

This committee would be charged

with making recommendations to DOT

and HHS concerning changes in our

regulations we could make to

accommodate electronic technology.

The committee would also make

recommendations about consistent

minimum standards for the technology

used in Federal drug and alcohol testing

programs. The Department anticipates

that, following the receipt of the

committee’s recommendations, DOT

and HHS will propose changes to Part

40 and the HHS Guidelines that will

result in authorizing the more

widespread use of electronic technology

in the program.

Meanwhile, the Department will make

some modest changes to its

requirements. For example, we will

permit greater use of faxes and scanned

computer images for reporting test

results. Additionally, we are permitting

laboratories to send electronic results

reports to the MROs, provided that the

laboratory and the MRO ensure that the

information is accurate and can be

transmitted in such a manner as to

prevent unauthorized access or release

of this information while it is

transmitted or stored. The Department,

at this point, is not requiring specific

transmission or security standards, but

as these are developed in the future, we

will provide them as guidance for

laboratories and MROs. Even when the

Department has changed its regulations

to permit greater use of electronic

methods, we expect to retain the option

to use a paper-based system, however.

This is because many of the participants

in our program, such as small

transportation employers, may not be

equipped to participate in a fully

electronic system.

MRO/Laboratory Conflicts of Interest

The Department has long believed

that the MRO has a uniquely important

responsibility for maintaining the

integrity of the Department’s drug

testing system. For that reason, since the

beginning of the Department’s program,

we have been concerned about the

potential of conflicts of interest between

MROs and other participants in the

system, particularly the laboratory. For

example, if an MRO is reviewing results

of a laboratory with which the MRO has

a financial relationship, it could

happen, or appear to happen, that the

MRO would be less likely to bring

problems in the laboratory’s test results

to light. In the NPRM, the Department

asked commenters for their thoughts on

conflicts of interest, particularly

whether the Department should state

with greater specificity the kinds of

relationship that involve conflicts or the

appearance of conflicts.

Comments

Some commenters questioned the

NPRM’s focus on the MRO-laboratory

relationship, saying there were other

relationships among participants that

could be as or more troubling (e.g.,

laboratory-collection site relationships).

Commenters also differed about what

the rule should say about laboratoryMRO relationships. Some commenters

favored a strict separation of roles,

while others said that the program

would be more efficient and less costly

if MROs and laboratories could

collaborate more closely. Some

commenters, in response to a preamble

question, supported adding more

specific guidance to the rule on what

sorts of relationships were considered

inappropriate.

A large majority of comments on this

issue said it was important for the rule

text to list the kinds of relationships that

the Department regarded as creating

conflicts of interest between MROs and

laboratories. The comments

acknowledged the significance of

maintaining laboratory/MRO

relationships that were free of such

conflicts, in order to maintain the

integrity of the program. In the absence

of specificity, however, a general

provision prohibiting conflicts or

requiring a certification that there were

none would be ineffective, they said.

Commenters generally agreed with the

list of conflicts listed in the NPRM

preamble, as a means of ensuring the

necessary separation of functions among

participants. Commenters who

dissented from this position usually

argued that to prohibit close MRO/

laboratory relationships would interfere

with the integrated organizational

arrangements that were most efficient in

providing services to customers

economically (e.g., one-stop shopping or

‘‘turnkey’’ programs).

DOT Response

We agree that other relationships in

the program might create conflict of

interest issues. However, we continue to

believe that the focus on the MROlaboratory relationship is appropriate. In

our view, the MRO is a key participant

in the process, whose role is to be the

most important protector of the

accuracy and integrity of the process. A

potential conflict of interest between an

MRO and a laboratory, whose results the

MRO must review, oversee, and, if

necessary, question, is a particularly

sensitive matter for the integrity of the

program. We urge appropriate caution,

use of firewalls, etc. to avoid potential

conflicts of interest among all

participants, but we believe that clear

regulatory guidance is important in the

MRO/laboratory relationship.

While we recognize that commenters’

views differ, we believe the program is

best served by avoiding MRO/laboratory

conflicts of interest or their appearance.

We believe that a clear separation of

their respective roles is necessary for

this purpose. We have maintained this

separation under the current rule, and

we do not have evidence that this has

unduly hampered the efficiency of the

program.

In response to comments, we have

added list of actions that we view as

creating the reality or appearance of a

conflict of interest. These examples are

not new creations: they codify guidance

that the Department has given in several

specific situations over the years. They

are essentially the same examples listed

in the preamble to the NPRM, with the

clarification that they apply to MROs

who actually review test results

produced by the laboratory in question.

This list of examples is not exclusive or

exhaustive: other situations may arise

that would constitute conflicts. The list

is the following:

(1) The laboratory employs an MRO

who reviews test results produced by

the laboratory.

(2) The laboratory has a contract or

retainer with the MRO for the review of

test results produced by the laboratory.

(3) The laboratory designates which

MRO the employer is to use,

recommends certain MROs, or gives the

employer a slate of MROs from which

to choose. We do not interpret this

provision to prohibit laboratories from

referring employers to a large, global list

of MROs (e.g., a list of all MROs who

have been certified by one of the

79478 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

national MRO training organizations), so

long as the laboratory does not edit the

list or express a preference or

recommendation among the MROs on

the list.

(4) The laboratory gives the employer

a discount or other incentive to use a

particular MRO.

(5) The laboratory has its place of

business co-located with that of an MRO

or MRO staff who review test results

produced by the laboratory;

(6) The laboratory derives a financial

or other benefit from having an

employer use a particular MRO; or

(7) The laboratory permits an MRO, or

an MRO’s organization, to have a

significant financial interest in the

laboratory.

Validity Testing

By validity testing, we mean testing

that laboratories conduct to deter and

detect tampering with tests. The two

most important categories of tampering

are adulterating a specimen (e.g.,

putting a substance into a specimen

designed to mask or destroy the drug or

drug metabolite that the specimen may

contain) or substituting a specimen (e.g.,

supplying water or some other

substance in place of urine). The NPRM

proposed to require laboratories to

conduct validity testing on all

specimens. It asked for comment on

whether MRO review and split

specimen testing should be applied to

specimens that laboratories found to be

adulterated or substituted, as they are to

specimens that test positive for drugs.

Validity testing is probably the most

difficult and controversial issue in this

rulemaking.

Comments

1. Adulteration

A significant majority of commenters

on the subject supported the idea of

testing for adulterants. Commenters said

that the purpose of such testing was to

counteract tampering, which some said

appeared to be on the rise in their

experience. They cited the increased

availability of substances and

techniques claiming to protect drug

users from testing positive for drugs,

which are quite commonly advertised in

publications and on the internet.

Many commenters cited the volatility

of the adulterant market, noting that the

popularity of particular adulterants rise

and fall. As countermeasures to one

substance are found, other adulterants

come into prominence, in a continuing

‘‘arms race’’ between those who try to

facilitate and those who try to deter and

detect ways of ‘‘beating the test.’’

Therefore, commenters said, there needs

to be flexibility in the ‘‘adulteration

panels’’ that laboratories use, to allow

them to keep up with an ever-changing

adulterant market. It is not helpful, in

view of this need for flexibility, to

mandate testing for specific substances

such as nitrites, several commenters

said.

Two employee groups said that there

was no evidence supporting the need for

adulterant testing. They also said that

adulterant testing was too burdensome.

One laboratory suggested that adulterant

testing should remain discretionary

with laboratories, rather than mandated

by the rule. Another commenter said

that there should be standardized DHHS

testing methodologies for adulterants,

just as there are for drugs. Several

commenters supported extending the

blind testing program to adulterated and

substituted specimens as a further

safeguard. A few commenters addressed

the issue of cost, but they did not agree

with one another about whether

adulterant testing would add significant

costs to the program. Supporters of

alternative testing methods (e.g., saliva,

hair, on-site testing) argued that their

methods would be quicker and more

effective at detecting adulterants than

the present laboratory-based urine

testing system.

2. Substitution

Generally, commenters who

supported testing for adulteration also

supported testing for substitution.

However, a number of commenters had

greater concerns about substitution

testing. Some comments, including one

extensive comment submitted by a

union, contended that the criteria for

substitution developed by HHS, and

incorporated in the NPRM, were faulty

and based on inadequate studies. In

particular, this comment criticized the

HHS criteria because the literature on

which the specific gravity and

creatinine levels had been based

included very few ‘‘paired studies’’

looking at both criteria at once. Other

comments criticized the studies because

they had not specifically covered certain

employee subgroups. A few comments

suggested changing the name of this sort

of specimen from ‘‘substituted,’’ which

they found too conclusory, to ‘‘hyperdilute’’ or something similar, which

they believed to be more neutral and

descriptive.

During the listening sessions and in

written comments, a number of

individuals said they, or people they

know, had been unfairly terminated on

the basis of substitution. These

individuals were not drug users, they

said, but had consumed large quantities

of water over a long work period. In

addition, they were often small-framed

minority women, vegetarians in some

cases. They suggested that a

combination of these circumstances

could have resulted in the natural,

innocent production of urine meeting

the substitution criteria. They sought

additional procedural protections and

revision of the substitution criteria to

prevent people from being unfairly

found to have substituted a specimen.

3. Split Specimen Testing

The Department presented three basic

options for comment concerning the

application of split specimen testing to

findings of adulteration and

substitution. The first option would

have continued the Department’s

current policy of prohibiting split

specimen testing in these cases. The

second option would require split

specimen testing in adulteration and

substitution cases, on the same model as

the current requirement for drug

positives. The third option would add to

the present system a requirement for the

laboratory to test an additional aliquot

of the specimen to ensure that the result

could be replicated.

All unions who commented favored

the second option. They believed this

was necessary if the system was to be

fair and provide due process to

employees whose specimens were

found to be adulterated or substituted.

They asserted that the scientific basis

and technical standards for adulteration

and substitution findings were weaker

than in the case of drug positives, but

pointed out that the consequences were

equivalent (or more severe, in some

cases). Employees should have the same

chance to double-check the former as

the latter. Some employers and service

agents also supported this approach,

principally on fairness grounds.

Supporters of the first and third

options, including a number of

employers and service agents, opposed

split specimen testing in adulteration

and substitution as providing a second

opportunity for an employee to beat the

test. In addition, they said that the

properties of many adulterants were

unknown, and an adulterant might

degrade in so short a time so that it

would fail to reconfirm on a split

specimen test. Variations in the findings

about the urine could result from

something as simple as the freezing and

thawing of the split specimen, one

commenter said. Among commenters in

this group, a number supported Option

3 in preference to Option 1 because it

would provide some additional

protection for employees without

having the disadvantages of opening the

split specimen.

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79479

4. MRO Review

Generally speaking, commenters lined

up in the same way concerning whether

MROs should review and verify

adulterated and substituted test results

as they did concerning split specimen

testing for these results. Unions and

other supporters said that MRO review,

parallel to that for drug positives,

should be made available as a matter of

fairness. For example, if a small female

flight attendant who has consumed a lot

of water on a long flight gets a

substituted test result, she should have

the opportunity to offer an explanation

to the MRO. If she made her case, the

MRO should verify the result negative,

just as in the case of a drug positive with

a legitimate medical explanation.

Opponents of MRO review for

adulteration and substitution cases said

that it would be cumbersome. Also,

there are not established standards for a

‘‘legitimate medical explanation’’ in the

adulteration and substitution area as

there are with respect to drugs, meaning

that MROs would be acting in a less

well informed way. Some commenters

said that there were no legitimate

medical explanations for the presence of

adulterants, so the medical review

process would be an empty exercise.

DOT Response

We begin with the premise that

tampering with drug tests is a bad thing

and a serious safety concern. When

people do so, it is probably because they

want to continue using drugs while also

continuing to perform safety-sensitive

duties. Continuing to do both these

things is precisely what the DOT drug

testing program, in the interest of safety,

is designed to prevent. To the extent

that people believe that they can

successfully beat a test, the deterrent

effect of the program is diminished. One

can oppose the concept of testing to

catch tampering only if one believes that

it is acceptable for people both to

continue using drugs and to continue

performing safety-sensitive duties.

There were no commenters who said

that they opposed the concept of testing

to catch tampering with drug tests.

Some commenters, however, said that it

was not proven that tampering was so

serious a problem as to warrant validity

testing. The majority of commenters

disagreed, and many were parties

(laboratories, MROs, C/TPAs) who have

significant experience in reviewing

specimens and test results. Our own

experience in working with participants

in the program is consistent with that of

commenters who believe that

adulteration and substitution are

relatively prevalent, serious issues

requiring a regulatory response. The

wide public advertising of substances

and techniques to protect drug users

from tests is further suggestive of a

thriving cottage industry designed to

help people beat drug tests.

The Department consequently will

make validity testing mandatory.

Laboratories will test all incoming

primary specimens for dilution,

substitution, and adulteration. We

believe that mandating that all

laboratories test all primary specimens

will result in greater uniformity of

testing methods. Testing methods must

be consistent with HHS requirements

and guidance (HHS Program Documents

35 and 37 at the present time), upon

which DOT will rely for purposes of this

rule. As noted above, we will coordinate

the effective date for mandatory validity

testing with the issuance of HHS

mandatory requirements on validity

testing. The Department is convinced

that testing in accordance with HHS

requirements and guidance results in

scientifically valid tests for pH,

creatinine, specific gravity, and various

adulterants.

Consistent with comments that it was

not advisable to list specific adulterants

in the rule, since they change rapidly,

the Department will simply rely on HHS

rules and guidance, which can change

to reflect new adulterants for

laboratories to test. The Department’s

final rule also minimizes statements of

requirements for laboratory testing

methodology, since that is also an area

in which we rely on HHS requirements

and guidance. We do not believe that

extensive duplication is necessary.

The Department has thought a great

deal about the HHS substitution criteria,

which were the subject of extensive

comment. HHS developed these criteria

based on an extensive review of the

literature (‘‘NLCP: STATE OF THE

SCIENCE—UPDATE # 1—Urine

Specimen Validity Testing: Evaluation

of the Scientific Data Used to Define a

Urine Specimen as Substituted

(February 14, 2000)’’). We are aware that

this literature review included only a

few ‘‘paired studies’’ that

simultaneously looked at both the

specific gravity and creatinine criteria.

Nevertheless, there is nothing in the

HHS literature review that suggests any

other criteria that would be more

appropriate for determining substitution

or that the existing criteria are

erroneous. Notwithstanding the critique

in the comment we received, no

scientific paper of which we are aware

has suggested criteria that it claimed

was more appropriate. It is very

significant that even the most vocal

opponents of the substitution criteria

were unable to provide a single

documented instance of an individual

meeting both substitution criteria

through natural means in a controlled

setting.

We are also aware that most of the

studies in the HHS literature review

were studies of the general population

that did not focus on specific subgroups.

This is an acceptable practice in

medical and scientific studies.

Moreover, the Department does not

believe that, to adopt generally

applicable substitution criteria, it must

demonstrate the suitability of the

criteria over and over again for every

conceivable subset of the population.

To provide further information about

these issues, the Department conducted

its own study. The text of this study is

available on the ODAPC web site

(www.dot.gov/ost/dapc). The study was

designed specifically to focus on two

issues on which commenters criticized

the HHS literature review, the absence

of paired studies and insufficient study

of female subjects. The DOT study made

paired measurements of urine creatinine

and specific gravity in a predominately

female (40 of 56) group of subjects.

All participants in the study were of

reasonable working age (19–56). All

participants volunteered to consume at

least 80 ounces of fluid spread evenly

over six consecutive hours. The protocol

asked for 40 ounces to be consumed

within the first three hours of this sixhour test period. This would be

immediately followed by the

consumption of at least another 40

ounces in the last three hours of the sixhour test period. Urine specimens were

collected prior to the start of the sixhour period and at the end of each

subsequent hour in the test period.

Urine specimens were also collected on

awakening the morning of the test day

and on awakening the morning

following the test day (this amounted to

a total of nine urine specimens being

requested from each participant).

Each participant was asked to

document the amount and type (water,

coffee) of fluid consumed from

awakening through completion of the

six-hour period, along with the total

amount of urine produced from

awakening through the six-hour period.

Height, weight, age, gender, ethnicity,

eating habits, and medications taken

regularly and on the day of the

collections were also documented. All

urine specimens were sent to an HHScertified laboratory where creatinine

and specific gravity were measured

using well-established laboratory

techniques.

The 56 subjects provided a total of

500 urine specimens. 504 specimens

79480 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

were expected; however, three

individuals did not collect one of the

specimens on awakening, and one

person was unable to complete the

second three hours of drinking per the

test protocol. Two participants were

unable to consume the minimum

amount of fluid originally intended

(total of 80 ounces, or approximately

2370 mL, spread evenly over the six

hours). The remainder consumed at

least the minimum requested. Twelve

participants (five men and seven

women) consumed over one gallon of

fluid by the end of their test periods.

Not one of the 500 specimens was

identified as ‘‘substituted’’ based on the

HHS criteria. This point deserves

emphasis. The DOT research involved

paired studies of predominately female

subjects who drank copious quantities

of water under controlled conditions.

This examination of paired values of

creatinine and specific gravity from 500

specimens collected under water

loading conditions strongly supports the

criteria developed by HHS. There was

no evidence that individuals, regardless

of gender or other factors and despite

consuming unusually large amounts of

fluids, are capable of physiologically

producing urine meeting the HHS

substitution criteria. We do note that

113 of the specimens did meet the

criteria for ‘‘dilute’’ specimens, as

defined by HHS. Under Part 40, a dilute

specimen does not constitute a refusal

to test.

The propriety of the HHS substitution

criteria was not the only area on which

comments were received on validity

testing. Several commenters questioned

the tests used to determine validity as

not being equivalent to the tests used in

drug testing. Specifically at issue was

whether or not the use of two different

technologies is required for the initial

and confirmatory tests.

These comments, and their references

to statements by two professional

toxicology organizations—the American

Academy of Forensic Sciences (AAFS)

and the Society of Forensic

Toxicologists (SOFT)—do not

successfully make a case that the HHSapproved testing methods for

adulteration and substitution are faulty.

Not all types of tests are the same. In

testing for the ‘‘HHS five’’ drugs, we are

looking for chemically complex

substances that we do not expect to find

in most specimens. We use an

immunoassay followed by gas

chromatography/mass spectrometry

(GC/MS). As applied, for example, to

amphetamines, the immunossay test

identifies a broader category of

substances including, but not limited to,

amphetamine and methamphetamine.

The GC/MS test is used to increase the

specificity of the testing process and

accurately prove the presence of

amphetamine or methamphetamine.

By contrast, creatinine is a very

simple substance that we always expect

to find in urine. It is readily identified

by colorimetric techniques, in which a

chemical is added to urine to cause a

color change and a special instrument

measures light absorbed by the solution.

It is not necessary with creatinine to

differentiate specific complex

substances from other substances that

may be present in the specimen.

Therefore, a second analytical technique

to provide greater specificity is not

needed. A single analytic technique

repeated on a second specimen to

ensure that we have a reproducible

result is much more to the point.

In the case of creatinine, the initial

validity test result is analogous to that

of a confirmation drug test result. It

produces a quantified result suitable for

use in determining whether the

specimen is substituted or diluted. The

second validity test performed on the

specimen is sufficient to support fully

the first validity test result. Because of

the nature of the creatinine, it is not

necessary to use two different testing

technologies to establish a test result

with certainty. (A similar point can be

made about alcohol.) The quoted AAFS

and SOFT statements, which apply

principally to tests for drugs and drug

metabolites, do not conflict with this

analysis.

We also point out that one important

purpose of the initial immunoassay test

for drugs is to eliminate negatives in a

cost-effective manner. It would be

possible to run two consecutive GC/MS

tests on a specimen and never use the

separate immunoassay technique. Such

an approach would lead to results that

are completely accurate and reliable, but

the reason we do not require this

approach is that it would be much more

expensive.

In the case of substitution, the specific

gravity test corroborates the creatinine

result. This provides a level of forensic

certainty equivalent to immunoassay

followed by GC/MS in the drug testing

case. Although the specific gravity tests

appear to be based on simple

technology, they have been established

as reliable through extensive use over

the many years in many clinical

settings.

One commenter suggested replacing

specific gravity with osmolality,

asserting that measurements of osmotic

concentration of urine are considered

more valid than specific gravity

measurements. HHS and DOT believe

that there is not a significant difference

between osmolality and specific gravity

for validity testing purposes. In fact,

specific gravity is used clinically much

more than osmometry. HHS-certified

drug testing laboratories have 12 years

of successful experience in testing for

creatinine and specific gravity testing

under the HHS guidelines, and we do

not believe that commenters have made

a compelling case for change.

We also note that there are additional

testing methods available for such

substances as creatinine, nitrites,

glutaraldehyde, chromium, and various

possible adulterants. The fact that other

tests exist does not mean that they must

be used to produce an accurate result.

The key point is that the methods we do

use must be accurate and above

reproach. DOT and HHS are convinced

that the methods we use do produce the

required accuracy for correct results.

Contrary to one commenter’s

assertion, the Department’s approach to

validity testing does not create a

‘‘presumption of guilt.’’ A confirmed

laboratory finding, whether for drugs,

adulterants, or substitution, is a matter

that calls for explanation. In the absence

of a satisfactory explanation, we are

justified in basing regulatory

consequences on the finding.

The Department, in short, has a

rational and sound scientific basis for

using the adulteration and substitution

criteria we have chosen. Nonetheless, to

ensure fairness and to provide

safeguards parallel to those available in

cases of positive drug tests, the

Department will add split specimen

testing and MRO review to its

procedures in these cases.

The Department is not legally

compelled to include split specimen

testing and MRO review in validity

cases. As explained in the preamble to

the NPRM (see 64 FR at 69081–82;

December 9, 1999), these additional

safeguards are required neither by the

Constitution nor by statute. The

Department’s decision is a matter of

policy, in the interest of providing

greater fairness to employees in the drug

testing program. The Department notes

that situations in which an adulterant is

naturally found or a substitution

naturally occurs are likely to be

extremely rare. At the present time, we

do not know of any such situations.

However, our policy to allow medical

review and use of the split specimen

will provide employees with an

additional level of protection and an

added degree of fairness.

With respect to the use of split

specimens in validity testing, the

Department’s process will parallel the

existing split specimen procedure in the

case of drug positives. Within 72 hours

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79481

of being notified by the MRO that his or

her test has been verified adulterated or

substituted, the employee may request a

test of the split specimen. A second

laboratory will test the split specimen.

Laboratories will use the testing

criteria set forth in HHS rules or

guidance. Under current HHS criteria

for adulterants, the test of the split

specimen is for the presence of an

adulterant, or, in the case of an

adulteration finding based on pH, to

ensure that the pH of the specimen

meets the same regulatory criteria as for

the primary specimen. In the case of

substitution, the split specimen must

meet the same regulatory criteria as for

the primary specimen in order to be

reconfirmed. As with drug positives, the

consequence of a failure to reconfirm is

a cancelled test.

With respect to MRO review, the

Department’s process will also parallel

the existing procedure for drug

positives. The employee will have the

opportunity to present a legitimate

medical explanation. The employee, as

is the case for all drugs except opiates,

has the burden of proof to demonstrate

to the MRO that a legitimate medical

explanation exists. To meet this burden

in the case of an adulterated specimen,

the employee will have to demonstrate

that the adulterant entered his or her

specimen through physiological means.

This will not be easy to do. Most

adulterants are substances that do not

naturally occur in urine. There is no

way one can physiologically produce

urine that includes such substances as

bleach, glutaraldehyde, or soap, for

example. There cannot be a legitimate

medical explanation for the presence of

these substances in urine, any more

than there can be a legitimate medical

explanation for the presence of PCP in

a specimen.

In cases where there is no reasonable

apparent legitimate medical

explanation, the MRO would verify the

adulterated result. However, if an

employee presents what the MRO

believes could be a legitimate medical

explanation, the MRO will tell the

employee he or she may obtain

additional evaluation from another

physician, acceptable to the MRO, who

has expertise relevant to the

explanation. This would ensure that the

MRO, standing alone, would not be

called on to make a decision for which

he or she lacked the needed expertise.

The referral physician would make a

recommendation about whether there

was a legitimate medical explanation.

The referral physician would evaluate

any information presented by the

employee in making his or her

determination. If the referral physician

found that there was a legitimate

medical explanation, the MRO would

review the referral physician’s

recommendation and, if appropriate in

the MRO’s judgment, cancel the test.

MROs would follow the same process

in the case of a substitution result. The

MRO review provision for substitution

emphasizes that it is not enough for the

employee to show that he or she has a

medical condition or has certain

personal characteristics. The employee

must establish the link between these

facts and the ability to physiologically

produce urine meeting the substitution

criteria. For example, a replication of

the employee’s original test result,

under carefully controlled conditions

(including direct observation) could

establish such a link.

To meet our fairness objectives, we

believe it is necessary to provide MRO

review that can result in the

cancellation of a test if the employee

provides a legitimate medical

explanation. Nevertheless, the

Department emphasizes that it is the

employee’s burden to prove that such an

explanation exists. The MRO is not

responsible for disproving an

employee’s assertions.

The Department will retain the word

‘‘substitution,’’ rather than changing to

a term like ‘‘hyper-dilute.’’ Given the

structure of the final rule, it seems clear

that a laboratory ‘‘substituted’’ result is

simply a confirmed result that must be

verified by an MRO before becoming

final, just like a confirmed drug

positive. HHS uses this term in the

Federal employee program, and it is

useful to keep terms as consistent as

possible between the two related

programs.

The Department works closely with

HHS on validity testing issues, and the

Department will use validity testing

criteria set forth in HHS requirements

and guidance. Validity testing is a

subject that HHS, like DOT, takes very

seriously, and HHS will issue additional

guidance, as needed, to support the

DOT validity testing program. We will

work with HHS to ensure that validity

testing remains as technically sound as

the rest of the DOT program. The

updated and clarified collection

procedures in this final rule will help

insure the integrity of the urine

specimen. In addition, each laboratory

will conduct validity testing under

specific HHS guidance and quality

control review, and the blind specimen

quality control program will include

adulterated and substituted specimens.

Validity testing has now become a factor

in the HHS evaluation of laboratories for

certification and recertification. In

addition, the application of split

specimen testing and MRO review to

validity tests will provide further

safeguards for employees, parallel to the

existing drug testing program.

Laboratory Problems

In September 2000, the Department

learned of a significant series of errors

by one laboratory involved in validity

testing. The first error that came to our

attention involved apparent misconduct

by laboratory personnel. Following a

test result that met HHS substitution

criteria, laboratory personnel apparently

backdated documents explaining a

minor irregularity in laboratory controls

used to check the accuracy of testing

machinery. These documents were then

placed in the ‘‘litigation package’’

intended for use in an FAA certification

proceeding involving the employee. To

make matters worse, someone allegedly

tore up a purported photocopy of the

original of the backdated documents,

and the laboratory official who signed

the litigation package (no longer

employed by the laboratory) allegedly

had claimed credentials he did not

have. These events undermined the

credibility of the laboratory in this case

so much that FAA enforcement

attorneys felt compelled to settle the

certification action.

Second, the laboratory made

significant errors in reading test results.

One error was the practice of

‘‘truncating’’ creatinine measurements

(i.e., expressing results only in whole

numbers). This practice, which was not

specifically mentioned in HHS Program

Document 35 but was specifically

contrary to Program Document 37,

causes any result in the 5 to 5.9 range

to be reported as a 5. Since a result of

5 or less is one of the criteria for

substitution, this practice could have

the effect of causing a specimen that

was outside the creatinine criterion for

substitution to be interpreted as meeting

this criterion. This throws into question

substitution results where the creatinine

measurement was a 5. (It does not affect

results where the creatinine result was

below 5.) In addition, laboratory

personnel apparently interpreted an

error message (‘‘LLL’’) from a machine

used to measure specific gravity as a

measurement of 1.000. There is not a

sound basis for making this

interpretation.

When we learned of these problems,

we immediately involved HHS. The

DOT and HHS Inspector Generals

reviewed the apparent evidencetampering. In addition, this situation led

us to add tampering with

documentation by a laboratory as a type

of noncompliance that can be subject to

a PIE proceeding (see § 40.365). The

79482 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

employer who had used the laboratory

in question terminated its contract with

the laboratory and offered to rehire five

employees whose test results had been

thrown into question by the laboratory’s

errors. The laboratory director

subsequently resigned.

HHS promptly conducted a special

inspection of the laboratory. Following

the inspection, HHS determined that the

laboratory had corrected the resultreading problems with substitution and

had been, since January 2000, in full

compliance with DOT and HHS

requirements. HHS also surveyed all

other laboratories to determine if any

had made similar errors in reading

results and to determine whether they

were in compliance. No one else had

made the error message interpretation

mistake concerning specific gravity.

However, HHS determined that, for

varying periods of time (in many cases

before the specific guidance on this

point was issued in Program Document

37, but in some cases after), 40 or more

laboratories had engaged in

‘‘truncating’’ creatinine results. All the

laboratories involved subsequently

stopped this practice, and all are now

reading these results properly.

In addition to these problems, HHS

also discovered that in some cases,

laboratories had reported tests as

substituted that did not meet both HHS

substitution criteria. That is, the

laboratories reported tests as substituted

that met the creatinine criterion, even

though they did not also meet the

specific gravity criterion.

HHS has examined each individual

substitution and adulteration test result

that a laboratory has reported since

September 1998, when Program

Document 35 took effect. In any case in

which a substitution result was based

on a creatinine reading of 5 at a

laboratory that was truncating results at

the time, or in which a substitution

result was reported that did not meet all

HHS criteria, HHS and DOT are working

to remedy the problem as it may have

affected individual employees. HHS is

in the process of sending a letter to each

MRO involved with one of the

approximately 300 specimens involved

informing the MRO that the test must be

cancelled. The letter directs the MRO to

inform the employer of the cancellation

and to tell the employer to attempt to

contact the employee with this

information. The employer is also told

to take any appropriate personnel action

in light of the cancellation.

HHS is also conducting special

certification inspections of each

laboratory that is performing validity

testing to ensure that all its validity

testing procedures are fully consistent

with HHS guidance. These inspections

will be completed this month. The

laboratories involved full compliance

with HHS validity testing requirements

will now be a condition of maintaining

their certification to participate in the

Federal and DOT drug testing programs.

We are deeply concerned about this

situation, because laboratory problems

of this kind can result in unfair

treatment of employees and adversely

affect the credibility and integrity of our

program. We point out, however, that

nothing in this situation suggests that

there is anything wrong with the criteria

and methods for validity testing. The

problems in this case were human

implementation errors, now corrected,

involving the reading of results and the

documentation and reporting of tests,

not in the testing process itself or the

scientific basis for it. The Department

believes that it is appropriate to

continue to implement validity testing

as called for in this rule.

Section-by-Section Discussion

The following part of the preamble

discusses each of the final rule’s

sections, including responses to

comments on each section.

Subpart A—Administrative Provisions

Section 40.1 Who Does This

Regulation Cover?

This section attracted little comment.

One commenter expressed concern

about potential coverage of volunteers

in one FTA program, while another

wanted to specify that contractors could

also be covered. The final rule specifies

that contractors, volunteers, and others

would be covered by Part 40 to the

extent that they are subject to other DOT

agency drug and alcohol rules.

The Federal Railroad Administration

(FRA) operates a post-accident drug and

alcohol testing program that antedates

Part 40 and differs in a number of ways

from the rest of the Department’s

programs (e.g., with respect to fluids

tested, drugs that are tested for). We do

not intend to interfere with the

implementation of this long-standing

program, and we have added a

paragraph making this clear.

Section 40.3 What Do the Terms Used

in This Regulation Mean?

Commenters expressed interest in

several of the definitions of terms in the

NPRM. A commenter made a technical

point that some kinds of evidential

breath testing devices (EBTs) do not

literally sample the ambient air, as the

definition of ‘‘air blank’’ provides. We

added a sentence to the definition

noting that for some devices, the ‘‘air

blank’’ is a reading of the device’s

internal standard.

A commenter noted that the

definition of ‘‘alcohol use’’ talks of

‘‘drinking or swallowing’’ rather than

‘‘consumption,’’ as in the past. The

reason for this change is to avoid

interpretations by enforcement

personnel that such actions as using an

inhaler that contain alcohol are ‘‘alcohol

use’’ for purposes of this part. For

example, the use of rubbing alcohol,

applied topically rather than imbibed, is

not intended to be a violation of this

part.

Commenters interested in the role of

service agents in the program asked for

definitions of ‘‘consortium’’ and ‘‘third

party administrator.’’ One commenter

provided proposed definitions, which

included a requirement for individuals

with certain certifications to play key

roles in the organization. We considered

the possibility of separate definitions for

‘‘consortium’’ and ‘‘third-party

administrator,’’ but we did not find any

basis for defining the terms separately.

There are no meaningful conceptual or

operational distinctions between

organizations that call themselves one

thing or the other of which we are aware

or which commenters explained. In the

way the terms are used in the

regulation, they are for all practical

purposes interchangeable.

Consequently, the final rule uses the

term consortium/third party

administrator (C/TPA) to refer to any

organization, however structured, that

provides or coordinates a variety of drug

and alcohol testing services to

employers. Organizations would not

have to change their names to conform

to this definition (i.e., a C/TPA that

currently calls itself a ‘‘consortium’’

would not have to call itself something

else).

Some commenters asked that C/TPAs

be regarded as ‘‘employers’’ (especially

consortia that serve small transportation

companies). (This comment is related to

the issue of C/TPAs serving as DERs,

discussed above in the ‘‘Principal Policy

Issues’’ portion of the preamble.) While

this rule broadens the authorized role of

C/TPAs in a number of respects, we

believe that the program works best

when C/TPAs and employers stay

within their respective roles. An

employer is an organization like an

airline, trucking company, transit

authority, etc. that provides

transportation services and employs

safety-sensitive workers. C/TPAs do

none of these things. They contract with

employers to provide drug and alcohol

testing services. We believe the

distinction between ‘‘employers’’ and C/

TPAs helps to avoid confusion and

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79483

counterproductive overlap in roles

between the two types of organizations,

and we are retaining the NPRM’s

statement that C/TPAs are not

employers. Any statements to the

contrary in DOT agency rules would be

changed in the agencies’ proposed

conforming amendments to this rule.

One commenter expressed concern

that it was troublesome to have service

agents contact a DER when there was

another company representative on the

scene of a testing event. This comment

appeared to assume that an employer

can have only one DER. This is not the

case. An employer can designate as

many DERs as it needs to carry out its

program effectively.

Several comments on the definitions

of ‘‘medical review officer’’ (MRO) and

‘‘substance abuse professional’’ (SAP)

asked that other professions or members

of professional groups be included

within the definitions. We will discuss

these issues in connection with the

MRO and SAP provisions of the rule.

Training and qualification matters are

found in substantive sections of the rule

(e.g., § 40.121 for MROs), and it is not

necessary to duplicate them here.

However, we have added to this section

definitions of terms that are used to

label different types of training for

MROs, SAPs, collectors, and BATs/

STTs (e.g., qualification training,

refresher training).

With respect to the term ‘‘chain of

custody,’’ we note that the definition of

this term is not intended to suggest that

the MRO is responsible, as part of his or

her chain of custody review, to examine

the internal laboratory chain of custody.

The MRO need only review the CCF

itself.

Commenters questioned the

definitions of ‘‘dilute’’ and

‘‘substituted’’ specimens. One

commenter noted that it was

unnecessary to suggest that a ‘‘dilute’’

specimen had been watered down by

the improper action of an employee. We

agree, and have expressed the

definition, like that of ‘‘substitution,’’ in

neutral, descriptive terms. These

definitions are augmented later in the

rule by quantitative criteria for dilute

and substituted specimens.

One commenter suggested slightly

rewording several definitions of terms

for the alcohol testing part of the

program. These suggestions generally

did not result in any significant

substantive changes in these definitions,

and we have left the definitions as they

were in the NPRM. A few commenters

asked for a different term in place of

‘‘service agent,’’ one suggesting

‘‘substance abuse service professional

(SASP).’’ The Department believes the

‘‘service agent’’ term is short, easily

understood, and inclusive, so we are

retaining it. Finally, for greater clarity,

we have added definitions of the ‘‘Office

of Drug and Alcohol Policy and

Compliance (ODAPC)’’ and ‘‘validity

testing’’ to this section.

Section 40.5 Who Issues Authoritative

Interpretations of This Regulation?

Section 40.7 How Can You Get an

Exemption From a Requirement in This

Regulation?

There were few comments about these

administrative provisions. One

commenter asked how to obtain answers

to interpretation questions, and another

asked how one might object to

interpretations of Part 40. We

recommend calling or writing ODAPC.

A commenter suggested publishing all

interpretations in the Federal Register

periodically. We believe that it is useful

to make all interpretations widely

available, and we will post them on the

ODAPC web site (www.dot.gov/ost/

dapc). We will also consider whether

publication in the Federal Register

would be a useful additional step.

This interpretation authority applies

to the application factual situations of

the provisions of this rule. The

Department is often asked whether, for

example, the rule requires the

cancellation of a test in a particular

circumstance. The answer to this

question is, in effect, an interpretation

of the text of the rule as applied to the

facts of the situation. ODAPC and the

General Counsel’s office work closely

with the operating administrations to

ensure consistency of all such

interpretations with both Part 40 and

the other DOT agency rules.

We will retain the provision that

makes only new guidance, issued after

publication of this rule, valid. We have

substantially rewritten Part 40. Much of

the substance of interpretations of the

former version of the rule is found in

the text of the new rule. Other guidance

pertains to a version of the rule that will

no longer exist. We anticipate

publishing additional guidance

pertaining to the new Part 40 (e.g., an

MRO manual) before the effective date

of the new rule.

We want to emphasize that an

exemption is not the same thing as a

waiver. An exemption is, in effect, a

rulemaking of particular applicability

that responds to an unusual situation,

not contemplated in the rulemaking and

not having general application to a wide

variety of situations. An agency cannot

properly make de facto generally

applicable amendments to a rule

through exemptions, because this would

circumvent the rulemaking process

requirements of the Administrative

Procedure Act. A waiver, on the other

hand, is a generally applicable provision

in a rule that permits regulated parties

to comply through an alternative means,

if certain conditions are met (e.g.,

§ 40.21).

Part 40 is an Office of the Secretary

(OST) rule. Consequently it is OST, and

only OST, that has the authority to grant

exemptions from it. Since Part 40 is

applied to regulated employers through

the other DOT agency drug and alcohol

testing regulations, exemptions to Part

40 are implemented via the other DOT

agency regulations. There may be

situations in which DOT agency

regulations impose requirements that go

beyond those of Part 40. In such a case,

a regulated party might need to obtain

an exemption from the additional DOT

agency provision as well as from a Part

40 provision.

Subpart B—Employer Responsibilities

Section 40.11 What Are the General

Responsibilities of Employers Under

This Regulation?

Most of the comments about this

section concerned proposed paragraphs

(d)–(f), which would have required

contracts or written agreements between

service agents and employers to include

a clause making compliance with Part

40 a material term of the contract. These

comments and the Department’s

response are discussed in the ‘‘Principal

Policy Issues’’ portion of the preamble.

A few commenters also objected to

language in the proposed paragraph (b)

saying that employers must ensure that

service agents comply with their

regulatory responsibilities. The thrust of

these comments was that employers do

not have the resources or expertise to

monitor the compliance of their

sometimes far-flung service agents. In

response, we have merged language of

paragraph (b) with § 40.15(c). It no

longer places an active compliance

monitoring responsibility on employers,

but simply says that the employer’s

good faith use of a service agent is not

a defense to a DOT enforcement action.

For example, if an employer’s MRO fails

to conduct verification interviews, the

employer could be subject to civil

penalties from a DOT agency (the MRO

could independently be subject to a PIE

proceeding). As an employer, you can

contract out your drug and alcohol

testing program functions, but you

cannot contract away your compliance

responsibilities.

79484 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

Proposed § 40.13 Nuclear Regulatory

Commission (NRC) Program

The NPRM proposed that there be

reciprocity between the DOT and NRC

drug and alcohol testing programs. A

number of commenters favored this

approach in principle, some asking that

the notion of reciprocity be extended to

other Federal testing programs. A few

commenters opposed the proposal,

saying that NRC rules did not measure

up to DOT rules. Other commenters

pointed to numerous differences

between the two regulatory programs,

with respect to program concepts,

specific requirements, forms, and

administration. Some suggested that a

reciprocity agreement be created

between the two agencies detailing how

these differences would be handled.

Others said that the more stringent of

the two rules on each particular point

should govern.

The Department has concluded that

the wide variety of program differences

between the DOT and NRC regulations

make it impractical to establish

reciprocity between the two systems.

These differences involve such matters

as testing methods, consequences of

some alcohol test results, alcohol testing

forms, reporting and recordkeeping,

inspection and enforcement procedures

and responsibilities, and return-to-duty

procedures. We believe it would be very

difficult to craft a provision that did

justice to both programs and decreased,

rather than increased, confusion among

employers and employees. While we

believe reciprocity and ‘‘one-stop

shopping’’ are worthwhile objectives,

we do not believe they are practically

achievable in this case. In addition, the

numbers of double-covered employees

and employers (either with NRC or

other Federal agencies) are quite small

in comparison to the total number of

parties covered by the DOT program.

For these reasons, we are not making

this proposed section part of the final

rule.

Section 40.13 How Do DOT Drug and

Alcohol Tests Relate to Non-DOT Tests?

This section is based on proposed

§ 40.15 of the NPRM. It continues to

require that DOT and non-DOT tests be

kept strictly separate. Comments were

generally supportive of this concept, but

some asked for clarification. Paragraph

(b), for example, clearly concerns

collections rather than other parts of the

testing process, and the text has been

changed to make this explicit. This

provision does not, as one commenter

wondered, mean that laboratories must

process DOT and non-DOT specimens

in separate batches. Another commenter

suggested that the ‘‘firewall’’ between

DOT and non-DOT tests would be

stronger if we required that an employer

use separate laboratories for the two

types of tests. We have not become

aware of any problems that use of the

same laboratory has created, and we

think that this idea would increase costs

and administrative complexity for

employers.

A few commenters mentioned a desire

to permit tests for other drugs, beyond

the ‘‘HHS five.’’ This is a long-standing

issue in the program, and DOT

continues to take the position that we

ought not go beyond the testing that

HHS has authorized and for which HHS

has certified laboratories. We agree with

comments that inadvertent use of nonFederal forms should be a correctable

flaw and that employers may

appropriately use the CCF for Federallyregulated tests (i.e., under the HHS

program for Federal agencies). The final

text makes changes to these effects. The

Department does not object to

laboratories creating a standard form for

non-DOT tests.

One of the most important provisions

of this section prohibits the use of DOT

specimens for tests other than the ones

explicitly authorized by this part. For

example, the rule forbids laboratories

and other parties from making a DOT

specimen available for DNA testing.

This incorporates in the rule text a longstanding DOT interpretation of Part 40.

We say this for two main reasons. First,

under these regulations, a properly

completed chain of custody

conclusively establishes the identity of

a specimen. No additional tests are

required for this purpose.

Second, the only thing a DNA test can

do is to determine, to a high level of

probability, whether a specimen and a

reference specimen were produced by

the same individual. If the DNA test

establishes a high probability that the

original specimen tested for drugs and

a reference specimen came from

different individuals, this may mean

one of four things. It could mean that

there was an error in the collection,

transmission, or handling of the

specimen. It could mean that the

employee provided a substituted

specimen (e.g., someone else’s urine) at

the original collection and provided his

or her own urine for the reference

specimen. It could mean that the

employee provided his or her own urine

at the original collection and substituted

someone else’s urine for the reference

specimen. It could mean that the

individual provided substituted

specimens from two different sources at

the original collection and for the

reference specimen. A DNA test cannot

distinguish among these possibilities.

Given a proper chain of custody, the last

three possibilities are significantly more

probable in practice than the first. A

DNA finding of difference between the

two specimens is not, then, a valid basis

for canceling a test.

Even if a DNA test is performed,

contrary to these rules, this section

prohibits employers from changing or

disregarding a verified positive test. In

such a case, regardless of the result of

the unauthorized test, the employer

cannot return the employee to the

performance of safety-sensitive

functions until and unless the employee

successfully completes the return-toduty process. The same point applies to

other unauthorized tests (e.g., if the

employee goes to his or her own doctor

and gets a second urine test or a blood

test).

Section 40.15 May an Employer Use a

Service Agent to Meet DOT Drug and

Alcohol Testing Requirements?

This provision is based on § 40.17 of

the NPRM. It provides that an employer

may use a service agent to carry out

drug and alcohol testing program tasks.

There were not many comments on this

section, and they generally supported

the provision. Some commenters sought

to limit the responsibility of employers,

saying they should not be accountable if

they failed to comply with the rules

because a service agent erred. As noted

above, we disagree: employers always

remain accountable for noncompliance,

whether they run their own programs or

outsource them. Another comment

suggested laboratories should not be

subject to DOT regulations, since they

are regulated by HHS. It is certainly true

that DOT relies on HHS for laboratory

certification matters. However,

laboratories have responsibilities under

Part 40 independent of their HHS

responsibilities (e.g., with respect to

relationships with MROs, release of

information, and validity testing), and

laboratories must be accountable to DOT

in those matters.

We agree, however, that we should

not require employers to have active

monitoring responsibilities with respect

to service agents, though employers may

choose to monitor their service agents’

performance. Therefore, we have altered

paragraph (b) to require employers

simply to make sure that service agents

meet regulatory qualifications. To this

end, employers may ask to see

documentation from service agents, who

are obligated to provide it.

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79485

Section 40.17 Is an Employer

Responsible for Obtaining Information

From its Service Agents?

This is a new section, responding to

problems that the Department has

encountered in the enforcement process.

It is closely related to the point, made

in previous sections, that an employer is

responsible for its own compliance with

DOT rules even in the face of mistakes

by service agents. The section says that

an employer has an affirmative

responsibility to get information from

service agents that is needed for

compliance purposes. For example,

suppose an applicant for a safetysensitive job takes a pre-employment

drug test, but there is a significant delay

in the receipt of the test result from an

MRO or C/TPA. The employer must not

assume that ‘‘no news is good news’’

and permit the applicant to perform

safety-sensitive duties before receiving

the result. Rather, the employer would

have to seek out the information about

the test result from the service agent

before putting the employee to work.

Section 40.21 May an Employer Stand

Down an Employee Before the MRO Has

Completed the Verification Process?

Proposed §§ 40.19–40.21 have been

relocated to Subpart Q, and we will

respond to comments on them in the

corresponding part of the preamble.

There is no § 40.19 in the final rule.

Section 40.21 concerns the issue of

stand-down. This issue was raised by

proposed § 40.159(a) of the NPRM. We

have relocated the section here since it

pertains primarily to the responsibilities

of the employer. We discussed the

general policy issues surrounding standdown in the ‘‘Principal Policy Issues’’

portion of the preamble.

The comments responding to

proposed § 40.159(a) focused almost

exclusively on the pros and cons of

stand-down as a policy. They did not

address the details of how a stand-down

policy would be implemented. In

formulating § 40. 21 of the final rule, we

have crafted provisions specifically

responsive both to the safely and

privacy/employee protections sides of

the issue that commenters raised.

Paragraph (a) states the general policy

prohibiting stand-down, except where a

DOT agency grants a waiver. We note

that this prohibition, and waivers of it,

apply in adulteration and substitution

cases as well as cases in which there is

a confirmed test result for drugs or drug

metabolites. Paragraph (b) tells

employers to send their waiver requests

to the DOT agency whose rules apply to

the majority of the employer’s covered

employees. For many employers, whose

employees are covered by only one DOT

rule, the decision is obvious. An

employer with covered employees in

more than one DOT agency category

would count the employees in each

category. For example, an employer

with 500 aviation personnel and 1000

truck drivers would send its request to

FMCSA. In such a case, FMCSA would

coordinate with FAA before making a

decision on the waiver request.

Paragraph (c) lists the items that an

employer must include in a waiver

request. The first set of items are

information that DOT agencies will use

in determining whether to grant a

waiver. It should be emphasized that

none of the items in paragraphs (d)(1)

are intended to create mandatory

prerequisites to receiving a waiver. That

is, we do not require that an

organization be a particular size, or have

an in-house MRO, or have had an

accident during the period before

verification was completed, in order for

its waiver request to be granted.

Any organization that wants a waiver

to do stand-down must have a written

company policy on the subject. An

employer must include its proposed

policy with its waiver request, making

sure that it covers seven mandatory

elements. The first is distribution of the

written policy to all covered employees.

Each employee subject to stand-down

must receive an individual copy of the

policy: posting on bulletin boards or

web sites is not sufficient. The second

pertains to confidentiality. There must

be an effective means of ensuring that

only those persons with a need to

know—the employee, the DER, and the

MRO—are told that the employee is

being stood down because of a

confirmed laboratory positive,

adulterated, or substituted test result.

We understand, of course, that the

employee’s supervisor will need to

know that the employee is being

removed from performance of safetysensitive functions, but the supervisor

must not be told the reason for the

action. It is sufficient that the supervisor

be given a general explanation (e.g.,

medical qualification reasons, personnel

evaluation reasons).

The third item is equality of treatment

within a given job category. An

employer cannot pick and choose the

employees to whom it will apply a

stand-down policy. That would be

unfair. The employer must choose to

stand-down all DOT-regulated

employees in each job category or none.

For example, an airline’s policy could

provide that all pilots would be subject

to stand-down, but mechanics would

not. However, the airline could not

choose to stand down some pilots, but

not others. When we use the term ‘‘job

categories’’ in this paragraph, we mean

broad, inclusive categories of

employees, rather than narrower subsets

of employee categories that might be

used for pay or personnel purposes.

The fourth item is a means of

ensuring that stand-down is applied

only with respect to the performance of

safety-sensitive duties. For example,

suppose a motor carrier’s policy calls for

stand-down with respect to drivers. The

laboratory reports a confirmed positive

drug test for Driver X. Driver X is

scheduled to drive a commercial motor

vehicle over the next few days. The

company would stand Driver X down,

so the driver would not be performing

a safety-sensitive function during the

verification period. The laboratory also

reports a confirmed positive drug test

for Driver Y. However, during the next

few days, Driver Y is scheduled to be in

training or to be on personal leave. The

motor carrier would take no action with

respect to Driver Y (including

notification of a supervisor), because he

or she would not be performing safetysensitive duties during the verification

period.

The fifth item, concerning pay status

of employees, is a very important matter

of policy. As discussed above,

employers who stand employees down

must continue to pay them until and

unless there is a verified adulterated,

substituted, or positive test result. This

obligation is to pay the employee in

exactly the same way he or she would

have been paid but for the stand-down.

For example, suppose an employer

stands down an employee from Monday

through Thursday. If the employee

would have been paid for 8 hours of

work on each of the four days in the

absence of the stand-down, then the

employee would be paid for this amount

of work. If the employee would only

have worked on, and been paid for, only

Tuesday and Wednesday, then the

employer would pay the employee for

these two days’ work. We note that this

obligation to pay the employee ends

with a verification of a positive,

adulterated, or substituted test, even if

the employee subsequently asks for a

test of the split specimen.

For the sake of both employers and

employees, it is very important that

verifications proceed quickly when an

employee is in a stand-down status.

Therefore, the sixth condition is that the

verification process must start at once

and take no more than five days (a time

period consistent with requirements for

the verification process elsewhere in the

rule). The process could exceed this

five-day limit only for extenuating

circumstances (i.e., the MRO provides a

79486 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

written statement to the employer that

a longer time is needed to complete

verification).

The seventh mandatory part of the

employer policy is that, if an employee

is stood down and the MRO verifies the

test negative or cancels it, the employer

must immediately return the employee

to safety-sensitive duties. The employee

must not suffer any adverse personnel

or financial consequences. The

employer must not maintain any

individually identifiable records of the

confirmed positive laboratory test. That

is, the employer would have to expunge

any individually identifiable record of

the confirmed positive laboratory test

and maintain only the record of the

individual’s verified negative or

canceled test. This places both the

employer and employee in the same

position they would be in if the

employer did not have a stand-down

policy. The MRO will have a record of

the laboratory test result that inspectors

can access if necessary.

This provision goes into effect on

August 1, 2001. DOT agencies will not

consider petitions for waivers before

this effective date. In considering

waivers, each DOT agency will use its

own procedures applicable to waivers

from its regulatory requirements. The

concerned DOT agency Administrator,

or his or her designee, will make each

decision about whether to grant a

waiver considering both the safety and

the employee protection aspects of the

matter. Administrators will informally

coordinate proposed responses to

waiver requests with ODAPC and other

affected DOT agencies, in order to

ensure intermodal consistency in the

Department’s responses. DOT agencies

will respond to all waiver requests in

writing, stating the reasons for their

decisions.

An Administrator can impose

additional conditions on the grant of a

waiver. The Administrator can also

revoke a waiver if the employer fails to

implement mandatory provisions of its

stand-down policy or conditions the

Administrator has placed on it. Finally,

if an employer implements a standdown policy without having a waiver,

or violates the terms of the waiver (e.g.,

tests some employees but not others in

a job category, fails to implement

confidentiality safeguards, fails to pay

employees during stand-down periods),

the employer will be subject to DOT

agency enforcement action (e.g., civil

penalties), just as in any other case in

which an employer violates DOT agency

drug and alcohol regulations.

Section 40.23 What Actions Do

Employers Take After Receiving Test

Results?

This section is based, in part, on

§ 40.159(b)–(g) of the NPRM. We have

added some material to it and placed it

in Subpart B in order to provide

employers with a convenient summary

of their obligations when they receive

various kinds of drug and alcohol test

results. We believe that the regulatory

text is self-explanatory, so we need not

comment on it further here.

There were very few comments on

§ 40.159(b)–(g). One commenter said

that the company should wait for the

signed report from the MRO before

taking action to remove an employee

from safety-sensitive functions after a

violation. We understand the usefulness

of having paper in hand, but we believe

that speed is more essential for safety

reasons once the MRO or BAT informs

the employer of a violation. Of course,

the requirement to immediately remove

an employee from the performance of

safety-sensitive duties necessarily

implies that employers may not ‘‘stay’’

this action pending any administrative

or legal proceeding (e.g., grievance,

arbitration, lawsuit) resulting from the

outcome of the testing process.

Paragraph (i) prohibits employers

from changing test results (e.g.,

determining that the laboratory result

was incorrect or that the MRO’s

judgment on a verification issue should

be overturned). Obviously, there may be

some cases in which a court or

administrative hearing officer will

require a test result to be expunged from

the record, or a test cancelled, because

of a problem in the testing process (e.g.,

a previously undiscovered fatal flaw).

However, this action does not involve

altering the laboratory finding or MRO

determination, as such.

Section 40.25 Must an Employer

Check on the Drug and Alcohol Testing

Record of Employees It Is Intending To

Use To Perform Safety-Sensitive Duties?

The NPRM (proposed § 40.329) would

have required MROs to transmit drug

test result information to additional

employers in certain circumstances. If

an MRO had personal knowledge that

an employee whose test the MRO had

verified positive worked in a safetysensitive position for another DOTregulated employer, the MRO would,

under certain conditions, tell the second

employer about the positive test,

without the employee’s consent. As

described in the ‘‘Principal Policy

Issues’’ section of the preamble, we are

not adopting this proposal as part of the

final rule.

In place of the proposed § 40.329, and

in the absence of a Federal data base,

the Department is incorporating in the

final rule a provision based on an

existing FMCSA provision. This

provision requires employers to check

on the drug and alcohol testing

background of new hires and other

employees beginning safety-sensitive

work. Employers would have to get

written consent from the applicant (in

the absence of which the employer

would not hire the person). The

employer sends the request for

information and the employee’s consent

to all other DOT-regulated employers for

whom the employee had worked within

the previous two years.

The employer cannot let the employee

perform safety-sensitive duties for more

than 30 days unless the employer has

obtained, or made and documented a

good faith effort to obtain, the required

information from previous employers

(as well as from firms to whom the

employee applied for safety-sensitive

work, where there was a positive test

result or a refusal). Of course, if the

employer finds that the employee has a

violation on his record, and the

employee has not successfully

completed the return-to-duty process,

the employer must immediately stop

using the employee to perform safetysensitive functions.

The Department believes that this

section will help to achieve some of the

purposes of the proposal to allow MROs

to share test results, with fewer

drawbacks. Admittedly, it affects only

new employees rather than current

safety-sensitive employees. However,

FMCSA has had success implementing

this provision, and it will help to screen

out employees who are not eligible to

perform safety-sensitive functions. It

will also ensure that employees who

violate the rules will have to go through

the SAP/return-to-duty process before

performing safety-sensitive duties. It

will therefore have safety benefits.

Because a substantial majority of all

DOT-regulated employees and

employers are in the motor carrier

industry, this provision will result in

only a modest increase in the

information collection burden of the

DOT program. The written consent

provision of the section avoids some of

the privacy concerns of the MRO

information sharing proposal.

In addition to seeking information

from previous employers, this section

also requires employers to ask

prospective employees if they have

failed or refused a DOT drug or alcohol

pre-employment test within the past

two years from an employer who did

not hire them. While we recognize that

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79487

applicants may not always tell the truth

about such events, we believe that it is

important to make this inquiry to help

ensure that employees are not put to

work in safety-sensitive positions

following a pre-employment test

violation without having completed

return-to-duty process requirements.

Section 40.27 Where Is Other

Information on Employer

Responsibilities Found in This

Regulation?

This is a new section, parallel to

several sections (e.g., concerning MROs)

in the NPRM. It is a list of other sections

of the rule that touch on matters of

particular interest to employers. We

believe it will make the rule easier for

employers to use if they have a quick

guide to other references in the rule to

employer responsibilities.

Subpart C—Urine Collection Personnel

Section 40.31 Who May Collect Urine

Specimens for DOT Drug Testing?

This introductory section to the urine

collection personnel subpart states that

only collectors meeting Subpart C

requirements can collect specimens in

DOT-regulated tests. They must meet

§ 40.33 training requirements. The only

subject of significant comment on this

section had to do with the requirement

that supervisors could not collect urine

specimens from employees they

supervise, unless no other qualified

collector was available and DOT agency

drug and alcohol regulations permitted

the supervisor to act in this capacity.

The intent of this provision is to

prevent potential conflicts between

supervisors and subordinates, as well as

to avoid any claims that a supervisor

was out to get an employee through

manipulation of the testing process.

However, commenters asked for

clarification of who we meant to cover

when we applied this prohibition to

supervisors. Several suggested we

should limit the prohibition to

‘‘immediate supervisors,’’ so that

individuals higher in the organizational

chain of command, who did not

supervise the employee day-to-day,

could act as collectors. The Department

agrees, and we have added this language

to the section.

Section 40.33 What Training

Requirements Must a Collector Meet?

There is a strong, though not

unanimous, consensus among people

familiar with the DOT drug testing

program that collections is the area of

the program where the most errors occur

that cause tests to be cancelled. For this

reason, the NPRM proposed several

requirements to strengthen training for

collectors, though it did not go so far as

to propose an equivalent of the BAT

course used for alcohol testing

personnel. We discussed the key points

of this issue in the ‘‘Principal Policy

Issues’’ section of the preamble.

We note here two additional changes

we made to reduce paperwork burdens.

In response to comments, we dropped

the proposed requirement that called on

collectors to ‘‘attest in writing’’ that they

have read and understood the rules and

DOT guidance. We also eliminated

requirements (from proposed § 40.35)

requiring organizations employing

collectors to maintain records of their

training. Collectors will maintain their

own training documentation, which

they must show on request to DOT

agency representatives as well as

employers or C/TPAs who use their

services.

In this section and a number of others,

the final rule makes reference to

guidance documents being available on

the ODAPC web site. These will be true

statements by the time the rule becomes

effective in August 2001. At the present

time, however, these documents are

‘‘under construction,’’ and they have not

yet made their debut in cyberspace.

Section 40.35 What Information About

the DER Must Employers Provide to

Collectors?

This section is not based on proposed

§ 40.35 of the NPRM which, as

mentioned above, is not included in the

final rule. It is a new section

incorporating a brief statement that

employers must make sure that

collectors have the name of and contact

information for the employer’s DER, so

that the collector can contact the

employer concerning any problems that

come up in the collection process (e.g.,

no shows, refusals). We recognize that

there may be some situations (e.g., postaccident tests at locations remote from

the employer’s place of business) where

this may not be feasible.

Section 40.37 Where Is Other

Information on the Role of Collectors

Found in This Regulation?

This is a section listing other sections

in the rule that collectors will find

useful in understanding their functions

in the drug testing program.

Subpart D—Collection Sites, Forms,

Equipment and Supplies Used in DOT

Urine Collections

Section 40.41 Where Does a Urine

Collection for a DOT Drug Test Take

Place?

Most comments on this section

focused on two issues. The first was the

conditions on use of a multistall

restroom. The NPRM proposed that a

multistall restroom could be used only

if a closed room for urination was not

available, and could be used only for

monitored collections. The proposed

rule text also said that a multistall

restroom must provide aural privacy to

the extent practicable. Several

commenters said these conditions were

too restrictive and would effectively

preclude employers from using

multistall restrooms for collections. This

was a problem, they said, because in

some industries, this was the most

readily available type of urination

facility. Some commenters also noted

what they viewed as an inconsistency

between the aural privacy provision of

this section and the provision in § 40.69

that called on monitors to listen for

sounds that might indicate tampering.

Some commenters also thought that

provisions of the proposal concerning

closed room urination facilities were too

restrictive, particularly the statement

that the room should have an external

water source, if practicable. They said

that many such facilities (e.g., patient

rest rooms in doctors’ offices) had

internal water sources, and the ‘‘if

practicable’’ language could lead to legal

challenges. They said it would be better

simply to require collection sites to

secure all water sources.

The Department has modified this

section in response to these comments.

The final rule provides that either a

closed room or multistall urination

facility is acceptable. In the former,

while it is preferable to have an external

water source, the rule makes clear that

a facility that has an internal water

source is also acceptable, if all sources

of water and potential adulterants are

secured and moist towelettes are

provided. This kind of urination facility

must have a full-length privacy door.

This means a door that is both opaque

and solid. For example, a glass door, a

door with a window or other means of

viewing the interior of the room from

outside, or a curtain is not adequate for

this purpose. Nor would it be

appropriate to have a video camera or

microphone monitoring the room.

If a multistall restroom is used as the

urination facility, the facility must meet

either of two requirements. First, a

multistall restroom may be used without

a monitor if all sources of water and

potential adulterants are secured.

Second, if these sources are not secured,

the collection must be a monitored

collection, meeting the requirements of

§ 40.69. The facility must have a partiallength privacy door (i.e., for the stall in

which urination takes place) to provide

as much visual privacy as possible. We

79488 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

have deleted the references in this

section to aural privacy and in § 40.69

to ‘‘active listening’’ by the monitor.

Regardless of which type of urination

facility a collection site uses, the

employee is the only person permitted

in the urination facility during the

collection of a specimen. This

requirement is intended to safeguard

both the employee’s privacy and the

integrity of the process. The only

exceptions to this rule are the observer

in a directly observed collection or the

monitor in a monitored collection.

Section 40.43 What Steps Must

Operators of Collection Sites Take To

Protect the Security and Integrity of

Urine Collections?

Commenters made a number of

suggestions about this section. One

commenter said that the requirement to

ensure that the collection site is secure

before each collection was too much

work. We disagree. Making this check is

vital to the integrity of the program.

Several commenters suggested that we

clarify the requirement that a collector

can have only one collection going on

at a time to allow a collector to continue

other collections while another

employee was drinking fluids in a ‘‘shy

bladder’’ situation. We think this is a

good idea that would avoid potential

delays at collection sites, and we have

added language to this effect.

The NPRM proposed that the collector

should keep the collection container

within view ‘‘to the greatest extent [he

or she] can.’’ A few commenters thought

this requirement should be absolute,

with the consequence being a fatal flaw

if the collector let the container out of

his or her sight. We do not believe that

the requirement should be absolute.

While it is important for the collector

and the employee to keep the specimen

in sight, a brief absence by the collector

ought not be a reason for cancelling a

test that otherwise meets Part 40

requirements.

As commenters suggested, we

clarified that authorized personnel who

may be present at the collection site

may include employer representatives,

that no one but direct observers and

monitors could be in the urination

facility with an employee, and that

collectors can remove a disruptive

person from the collection site.

Section 40.45 What Form Is Used To

Document a DOT Urine Collection?

Earlier this year (June 23, 2000), HHS

issued a new CCF for use in both the

Federal employee and DOT drug testing

programs. The references to the CCF in

this rule are to the new form. Most

provisions of this rule become effective

on August 1, 2001, the same date use of

the HHS form becomes mandatory for

use in the Federal employee program.

(Before August 1, 2001, participants in

both programs have the option of using

either the old or the new form.)

Consequently, there will be no

disconnect between the HHS form

requirements and the requirements of

this rule.

A few comments suggested allowing

the collector to sign CCFs in advance,

presumably to save time during

collections. We think this idea is fraught

with potential for misuse or theft of

signed forms, and we will maintain the

prohibition on this short cut. We have

added a specific requirement for the

MRO’s phone and fax numbers, as a

commenter suggested. A few

commenters also suggested allowing the

use of foreign-language versions of the

form in the U.S., as well as in other

countries. We have incorporated this

suggestion, with the stipulation that use

of a non-English version of the form that

ODAPC has reviewed is allowable in

any situation (here or in another

country) only if both the employee and

collector understand and can use the

form in that language. For example, a

collector who does not read French

could not use a French language form,

even for a French-speaking employee.

Section 40.47 May Employers Use the

CCF for Non-DOT Collections or NonFederal Forms for DOT Collections?

Some commenters supported

permitting the use of the Federal CCF

for non-DOT collections. Some of these

comments favored adding boxes to the

form that collectors could check for

‘‘DOT’’ or ‘‘non-DOT’’ collections. We

have believed since the beginnings of

the DOT program that it is very

important to maintain ‘‘truth in testing.’’

If a form says ‘‘DOT’’ or ‘‘Federal’’ on

it, despite whatever fine print

qualifications or check boxes might be

included, the form may easily imply to

the employee that he or she is being

tested under Federal law. If this is not

true, as in the case of a ‘‘company

policy’’ test, then we are knowingly

misinforming the employee. That is

unfair. Moreover, ‘‘company policy’’

tests that do not meet DOT

requirements, but are conducted using

the CCF, could implicate the DOT

program in legal challenges to the nonDOT tests. We will maintain the existing

prohibition.

Generally, most commenters on the

subject agreed with the NPRM’s

proposal to make use of a non-Federal

form in a DOT test a ‘‘correctable flaw.’’

A few comments questioned the need

for the written correction. Correcting the

flaw will ensure that there was an

appropriate explanation for use of the

non-DOT form (e.g., a post-accident test

where nothing else was available, a

simple mistake) and will help to

educate the collector involved about the

need to use the correct form. We will

also keep this provision in the final rule.

Section 40.49 What Materials Are

Used To Collect Urine Specimens?

There were few comments on this

section, which requires the use of a

‘‘DOT Kit’’ (see Appendix A for details).

Laboratories and MROs should treat as

a ‘‘red flag’’ any situation in which a

non-conforming kit is used. While use

of a non-conforming kit is not a fatal or

correctable flaw in the testing process,

laboratories and MROs should, if they

discover that a non-conforming kit was

used for a collection, check to make sure

that correct collection procedures were

used and that no fatal flaws occurred.

Use of a nonconforming kit is a rule

violation that can subject the user to

consequences under DOT agency rules.

Section 40.51 What Materials Are

Used To Send Urine Specimens to the

Laboratory?

This provision concerns shipping

containers. In response to a comment,

we have omitted a reference to a

standard ‘‘box,’’ leaving the provision as

a performance standard requiring a

container that adequately protects the

specimen from damage during shipping.

Subpart E—Drug Test Collections

Section 40.61 What Are the

Preliminary Steps in the Collection

Process?

Commenters responded to a variety of

detailed issues in this section. With

respect to employees who showed up

late for a test or not at all, several

commenters said it was common for

employees not to have appointments. As

a result, employees simply appeared at

the collection site, and collection site

people had no notion whether they were

on time or not. Commenters suggested

that the proposed ‘‘no show’’ provision

be limited to situations in which the

collection site was at the employee’s

worksite or an appointment had been

scheduled. We agree, and have added

language to this effect.

Some commenters thought it was

unreasonable to ask collection sites to

do their work on a timely basis, and

they therefore objected to the proposed

requirement that the collection process

begin without delay. We believe that, for

the sake of both employers and

employees, timeliness is essential for

decent customer service. However, we

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79489

will respond to concerns about the

flexibility of this provision by adding

the modifier ‘‘undue.’’ We will also note

in § 40.209 that a collector delay is not

a ‘‘fatal flaw.’’

The NPRM stated that when alcohol

and drug tests were being given to the

same employee at the same site, the

alcohol test should be given first. In

response to comments concerned about

backups in the testing process, we have

provided additional flexibility and

added an example of a situation in

which an employee’s urine collection

might be conducted first.

The NPRM would have prohibited the

collection of urine from an unconscious

employee by means of catheterization. A

few comments asked for clarification in

other situations involving catheters.

Some also suggested testing by

alternative means in these cases (e.g.,

hair, saliva). The Department is

clarifying this section to prohibit

collecting urine by catheterization not

only from an unconscious employee,

but also from a conscious employee.

The former raises consent issues, and

the latter, even given consent, raises

safety issues. However, in the case of an

employee who normally voids through

self-catheterization (e.g., for medical

purposes), the collector must require the

employee to provide a specimen in that

manner.

With respect to alternative testing

technologies such as hair testing, saliva

testing, and on-site testing, which

commenters recommended in context of

several sections of the NPRM, the

Department will wait upon the action of

HHS before proposing to incorporate

additional methods. Approval of these

or other methods, and establishment of

requirements and procedures for them,

are matters primarily within the

expertise of HHS, which is currently

considering them with the assistance of

the Drug Testing Advisory Board

(DTAB).

Concerning identification of

employees, commenters suggested that a

driver’s license or similar governmentissued ID would be acceptable in lieu of

an employer-issued credential. On the

other hand, some comments pointed out

that the credibility of employer-issued

ID might be doubtful in the case of a

self-employed individual. We have

modified the section on both points. A

driver’s license or other governmentissued photo ID will be acceptable, and

an employer-issued ID from an owneroperator or other self-employed person

will not.

Many of the same commenters who

objected to the proposed requirement to

have collectors search boots also

objected, for similar reasons, to the

proposed requirement (similar to that of

the existing rule) to have employees

empty their pockets. We believe that

taking objects out of one’s pockets is a

minimal intrusion into the employee’s

privacy, which can help deter and

detect some attempts to cheat on tests.

In addition, this is a provision that is

paralleled in HHS guidelines. The final

rule retains the proposed requirement.

A few commenters objected to the

provision that would bar requiring

employees to sign consent forms,

waivers, releases, etc. concerning the

collection and testing process. These

comments did not explain the reason

why exacting signatures on such

documents was necessary for the DOT

testing process, and we do not believe

that it is. We have retained it, but

moved it to Subpart Q and made it

applicable to all service agents, not just

collection sites. One comment suggested

that collection sites be able to have

employees sign consent forms with

respect to non-DOT tests. This rule does

not limit employers’ or collection sites’

actions concerning non-DOT tests, but

the rule does require strict separation

between DOT and non-DOT testing

procedures. This includes separate

paperwork for a DOT and non-DOT test

conducted with respect to the same

employee during his or her visit to a

collection site. Such a consent form

must not be part of the paperwork for

a DOT test, and it could not apply to the

DOT test or be filled out at the same

time the employee was filling out the

paperwork for the DOT test.

Section 40.63 What Steps Does the

Collector Take in the Collection Process

Before the Employee Provides a Urine

Specimen?

Commenters raised few issues

concerning this section. A commenter

wanted to eliminate the prohibition on

the employee flushing the toilet after

providing the sample, but we will retain

this provision because it limits

opportunities to flush away evidence of

adulteration. (However, inadvertantly

flushing the toilet does not create a

‘‘fatal flaw.’’) Another commenter

suggested training collectors in how to

detect attempts to tamper with

specimens. We think this is a good idea,

and our guidance will suggest it.

However, we do not think it is necessary

to incorporate it in rule text.

Section 40.65 What Does the Collector

Check for When the Employee Presents

a Specimen?

Some commenters noted that the

NPRM omitted the existing provision

concerning taking an employee’s body

temperature when the specimen

temperature was out of range. This was

intended. Many collectors are not

medically trained, and the accuracy of

some thermometers is not certain. The

provision has not been too useful under

the existing rule, and we will not

include it in the final rule. Other

comments requested revision of the

temperature range (e.g., to be between

94 and 100 degrees). While this idea has

some appeal, we believe we need to

keep Part 40 consistent with HHS

provisions on this matter.

Other commenters asked for

clarification whether, when one

specimen has not met regulatory

requirements (e.g., out of temperature

range, insufficient volume), the

specimen should be sent to the

laboratory for testing, as well as any

subsequent specimen that is collected.

We agree, and have included specific

directions on this point. For example,

when the first specimen is out of

temperature range, and a second

specimen is collected under direct

observation, both specimens would be

sent to the laboratory and tested. On the

other hand, if the first specimen were

out of temperature range, and the

employee refused to provide a second

specimen under direct observation, the

first specimen would be discarded and

the event simply treated as a refusal.

Section 40.67 When and How Is a

Directly Observed Collection

Conducted?

Directly observed specimens are

controversial because of their greater

impact on employee privacy. They can

be useful because they reduce the

opportunity for tampering. On privacy

grounds, some commenters, including

unions and some service agents, would

prefer not to conduct directly observed

collections at all. In any case, these

commenters opposed adding any

situations in which direct observation

was required or authorized. Other

commenters said that the benefit of

greater protection against specimen

tampering warranted direct observation

in situations that suggested a heightened

risk of tampering.

The Department agrees with the latter

comments. In situations that may create

a higher risk or greater incentive for

tampering (e.g., the previous collection

was verified positive, adulterated, or

substituted, but the test had to be

cancelled because the split specimen

was unavailable for testing; the previous

specimen was invalid and there was no

adequate medical explanation;

temperature out of range; apparent

tampering with the specimen at the

collection site), the interests of the

integrity of the testing process, with its

79490 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

safety implications, outweigh the

additional privacy impact of the direct

observation process. On the other hand,

dilute specimens may have a number of

innocent causes (e.g., someone likes to

drink a lot of water). A dilute specimen

does not necessarily imply the same

higher risk of tampering upon

recollection, so the final rule does not

authorize direct observation in this case.

The existing rule and the NPRM both

called for use of a same-gender direct

observer. Some comments objected to

this requirement, saying it created

practical problems in collection sites

that were staffed by only one collector.

Other commenters insisted on retaining

this requirement as a matter of privacy.

We believe there is no alternative to

retaining the same-gender observer

requirement. Use of opposite gender

observers would not only go counter to

deeply held societal norms of privacy

(i.e., the basic reason for separate men’s

and women’s rest rooms in public

places), but might raise genuine safety

concerns, particularly on the part of

female participants. We would point out

that the observer need not be a trained

collector, so that another same-gender

person could be enlisted for the task.

One commenter recommended we

add a provision telling the collector or

employer, as appropriate, to explain to

the employee why a directly observed

collection needs to be conducted. We

believe that this is a good idea, and we

have included a requirement in the rule

to this effect.

Section 40.69 How Is a Monitored

Collection Conducted?

Much of the comment on this section

echoed the comments on § 40.41,

supporting the use of multistall

restrooms as urination facilities and

urging the Department to permit the use

of monitored collections at the

collection sites at the employer’s

discretion. The discussion of multistall

restrooms and monitored collections in

§ 40.41 is the Department’s resolution of

these issues. This section sets forth the

procedures to be used for monitored

collections.

A few commenters focused on the use

of toilet bluing agents in monitored

collections. They suggested that bluing

not be required except in the toilet the

employee is using while providing the

specimen. We agree with this point with

respect to a monitored collection. In a

case in which a collection uses a

multistall restroom as a urination

facility but does not conduct monitored

collections, however, all toilets must be

secured, including the use of bluing.

A number of commenters again

objected to the requirement that the

monitor be of the same gender as the

employee, essentially for the same

reasons that commenters objected to the

same gender requirement for direct

observers. They added that, in the case

of monitors, there is a less intense

privacy concern because the monitors

do not actually watch the employee

urinate. We agree that the privacy

concern is less intense in this case, and

for that reason we permit the use of

opposite-gender monitors who are

medical professionals. Medical

professionals are trained to conduct

themselves properly and are less likely

than other persons to raise privacy and

safety concerns among employees. But

legitimate privacy and safety concerns

still exist to a degree in the monitored

collection situation, and we believe that

monitors who are not medical

professionals should continue to be the

same gender as the employee, as under

the current rule.

Section 40.71 How Does the Collector

Prepare the Specimens?

Proposed § 40.71, concerning single

specimen collection procedures, has

been deleted, as all collections will now

be split specimen collections. This

section is based on proposed § 40.73.

There were few comments on this

section. One suggested that the failure of

the employee to initial the tamperevident seals be regarded as a refusal to

test. We do not think that that is the best

solution to this problem. The individual

has, after all, provided a specimen. By

having the collector note the problem in

the remarks line of the form, we

preserve a record that the collection

proceeded properly. In this section, we

also clarify at several points that the

collector, not the employee, performs

several tasks.

Section 40.73 How Is the Collection

Process Completed?

This section is based on § 40.75 of the

NPRM. Commenters addressed a

number of technical points. Some

commenters wanted to put a time line

in the section to expedite proceedings.

We agree, and we have added a 24-hour/

next business day requirement for

transmittal of relevant copies of the CCF

and the specimen itself. As another

commenter suggested, we do encourage

the immediate faxing of CCF copies to

the MRO and DER.

A commenter asked that we

specifically prohibit employees from

providing medical information on the

CCF. We agree, and we have spelled out

this point in § 40.61(g). Another

commenter suggested deleting the

requirement for a ‘‘box’’ as the shipping

container. We have deleted this

requirement as a matter of flexibility,

both here and in Appendix A, though

we retain mention of a box as an

example of something that can be a

shipping container.

A commenter suggested that we

eliminate the proposed requirement to

note the entry for a specific courier or

shipping service on the CCF. This

requirement is part of the HHS CCF and

instructions, so for consistency’s sake

we will retain it. However, we also

specify in § 40.209 that omitting this

information is not a fatal flaw.

As indicated previously, the shipping

container seal was used primarily to

seal the shipping container (box).

Laboratories still tested the specimens

when the shipping container seal was

broken, provided the seals on the bottles

remained intact. Based on this fact, we

have removed the requirement for a

shipping container seal to be placed on

a shipping container. The same

rationale applies to placing a shipping

container seal on the plastic bag. The

construction of the plastic bag is such

that any tampering will be evident, even

without the seal. Consequently, the final

rule does not include any requirement

for placing a shipping container seal

across the opening of the plastic bag or

for the collector to sign or initial and

date such a seal.

Subpart F—Drug Testing Laboratories

Section 40.81 What Laboratories May

Be Used for DOT Drug Testing?

The only comments on this section

concerned the application of the PIE

process to laboratories. Some

laboratories and other commenters

believed laboratories should not be

subject to PIEs, since they are subject to

HHS certification requirements. We

believe that laboratories are service

agents providing services to DOTregulated employers no less than other

parties subject to the PIE provision.

Moreover, some Part 40 requirements

affecting laboratories (e.g., information

release, conflicts of interest, validity

testing requirement) are not enforced by

HHS through its certification

procedures. For these reasons, we

believe laboratories should remain

subject to the PIE process. However, we

specify in § 40.365 that the Department

does not intend, as a matter of policy,

to initiate a PIE proceeding concerning

a laboratory with respect to matters on

which HHS has taken action under its

certification process.

Section 40.83 How Do Laboratories

Process Incoming Specimens?

We have added a provision to this

section specifically requiring

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79491

laboratories to comply with HHS

guidelines concerning accessioning and

processing specimens. We do not

believe it is necessary to duplicate

significant portions of the HHS

guideline provisions concerning

laboratory processing of specimens, and

we have therefore eliminated some

provisions of the proposed Subpart F,

such as § 40.87 and portions of this

section and § 40.95.

Some commenters addressed the

portion of the NPRM that discussed

situations in which the color of the

primary and split specimen differ.

Because we will require a standardized

collection kit using a single collection

container, we believe that specimens

failing to be color-coordinated should

no longer be a problem, so we have

deleted this provision. This material is

covered in the HHS guidelines, so we do

not need to repeat it here. We did

incorporate a commenter’s suggestion to

direct the laboratory to retain a

specimen for five working days while

waiting for the correction of a

correctable flaw.

A few commenters recommended

that, when a laboratory notes that a split

specimen is unavailable for testing, the

laboratory should cancel the test then

and there. We disagree. Most tests turn

out to be negative, and employees do

not request a test of the split specimen

in all other cases. Therefore, there is a

good probability that the test of the

primary specimen will not turn out to

be futile.

Section 40.85 What Drugs Do

Laboratories Test for?

Section 40.87 What Are the Cutoff

Concentrations for Initial and

Confirmation Tests?

These technical sections have

changed very little from the existing

rule. A few commenters supported, and

a few others opposed, allowing to test

for other drugs (e.g., barbiturates,

benzodiazopenes, ‘‘designer drugs’’) in

addition to the ‘‘HHS five.’’ This issue

has been debated from the inception of

the program. As the Department has

said in the past, we believe the stability

and reliability of the program are well

served by limiting testing to the ‘‘HHS

five.’’ HHS has established testing

protocols and cutoffs for these drugs,

and laboratories are subject to HHS

certification for testing of these five

drugs. This is not true for other drugs.

Section 40.89 Are Laboratories

Required To Conduct Validity Testing?

Section 40.91 What Validity Tests

Must Laboratories Conduct on Primary

Specimens?

Section 40.93 What Criteria Do

Laboratories Use To Establish That a

Specimen Is Dilute or Substituted?

Section 40.95 What Criteria Do

Laboratories Use To Establish That a

Specimen Is Adulterated?

These sections are the laboratoryrelated provisions concerning validity

testing. We discussed validity testing

extensively in the ‘‘Principal Policy

Issues’’ portion of the preamble,

including issues pertaining to the

scientific validity of adulteration and

substitution criteria.

Section 40.89(b) states that

laboratories continue to be authorized to

conduct validity testing. This sentence

is included to avoid anyone mistakenly

concluding that, until validity testing

becomes mandatory, there is a question

about whether it can remain a voluntary

part of the DOT drug testing program, as

it is today. (The parallel section of the

amendments to current Part 40,

§ 40.205(b), is for the same purpose.)

When HHS issues its mandatory

requirements on validity testing, DOT

will amend § 40.89(c) to insert a date on

which DOT will require all DOT

specimens to be subject to validity

testing. We would not make this date

earlier than August 1, 2001, even if HHS

issues its requirements before that date.

As noted in that discussion, this rule

will not specify adulterants that must be

tested, given the changes that can be

expected in the popularity of various

substances. However, we expect

laboratories to be able to identify all

those listed in up-to-date HHS guidance

or rules. For example, we have not

listed nitrites in this rule, but current

HHS guidance calls on laboratories to

test for nitrites. If nitrites cease to be a

significant adulterant, and other

substances arise to take its place, HHS

guidance or rules will change as well.

One point we believe to be quite

important is that laboratories should

remain vigilant for new adulterants. If a

laboratory finds a substance it cannot

identify that appears to act as an

adulterant or interfering substance, the

rule directs the laboratory, after

checking with another laboratory, to

inform ODAPC and HHS about it. Doing

so will enable us to react as quickly as

possible to new adulterants being

marketed.

We also note that, while the

requirements for split specimen testing

for adulterated and substituted

specimens and MRO review will take

effect within 30 days of the publication

of this rule, mandatory validity testing

is not required to begin until further

notice from DOT. We will issue this

notice in conjunction with the issuance

by HHS of its mandatory requirements

for validity testing. We hope that this

will be on or before August 1, 2001.

This should give those laboratories who

currently are not conducting validity

testing sufficient time to prepare to

implement these requirements fully.

Section 40.97 What Do Laboratories

Report and How Do They Report It?

This section is based on parts of

proposed §§ 40.95 and 40.97. Some

portions have been deleted as

duplicative of HHS materials. The topic

of greatest interest to commenters was

the proposal to continue the current

requirement that laboratories transmit

test results directly to MROs, without

using a C/TPA or some other party as an

intermediary. C/TPAs made many of the

same arguments on this point as they

did with respect to the transmission of

results from the MRO to the employer.

There is only one party in the DOT

drug testing system who is entitled to

see a confirmed laboratory result. That

is the MRO. Other parties, including

collectors, employers (except in a

limited way if a stand-down waiver is

granted), SAPs, and C/TPAs are not.

These other parties are entitled to learn

of a result only after the MRO has

verified it. To permit a C/TPA to receive

a confirmed laboratory result and then

transmit it to the MRO would directly

violate this key principle. We do not

think that, in the present state of the

health care industry, there should be

serious problems with MROs having

appropriate technology to receive

results.

As discussed in the ‘‘Primary Policy

Issues’’ part of the preamble, the

Department has agreed to permit C/

TPAs to act as intermediaries in

transmitting results from MROs to

employers. However, we believe that

this situation is quite different from

allowing C/TPAs to act as an

intermediary in transmitting laboratory

results to the MRO.

A number of commenters supported

allowing the electronic transmission of

result reports, especially negatives.

Paragraph (b) of this section does permit

considerable use of electronic methods.

Beyond that, the Department will

consider additional use of electronic

methods through the advisory

committee process discussed in the

‘‘Primary Policy Issues’’ portion of the

preamble.

79492 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

The NPRM mentioned transmitting

negative results within 72 hours. Some

commenters thought this period should

be shortened to 24 or 48 hours, while

one laboratory thought it would be too

burdensome to use couriers on

weekends to meet this goal. The final

rule says that results should be

transmitted to the MRO on the same day

or business day after review by the

certifying scientist is complete. Besides

taking care of any weekend worries, this

provision, in tandem with the use of

electronic methods permitted under the

rule, should result in expeditious

transmission of results.

Section 40.99 How Long Does the

Laboratory Retain Specimens After

Testing?

We have simplified this section.

Specimens which were positive,

adulterated, substituted, or invalid must

be kept for one year. In response to

requests from commenters, we have

provided that the laboratory must keep

the specimens longer only if they

receive a request from an employer,

employee, MRO, C/TPA, or DOT agency

representative. Absent such a request,

the laboratory may discard the

specimen. This rule applies to primary

and split specimens alike. With respect

to negative tests and specimens rejected

for testing (e.g., because of a fatal or

uncorrected flaw), the laboratory should

follow HHS guidance. We do not believe

it is necessary to restate the guidance

here.

Section 40.101 What Relationship May

a Laboratory Have With an MRO?

This section focuses on potential

conflicts of interest between MROs and

laboratories. We discussed comments on

this issue and the Department’s

responses in the ‘‘Principal Policy

Issues’’ portion of the preamble.

Section 40.103 What Are the

Requirements for Submitting Blind

Specimens to a Laboratory?

The NPRM proposed to reduce the

number of blind specimens employers

and other program participants were

required to send to laboratories. We

made this proposal because it would

reduce costs and burdens and because

the laboratory testing program appears

to be running very smoothly. Comments

were divided on this issue. A majority

of commenters, especially from

employers and their groups, supported

the proposal. Some said they had never

heard of a laboratory error. Others said

that blind specimen testing had outlived

its usefulness and should be eliminated.

On the other hand, a number of

commenters said that to reduce the

number of blind specimens would

endanger the accuracy and integrity of

the laboratory testing program.

We also received a number of

comments saying that if we make

validity testing mandatory, adulterated

and substituted samples should also be

included in the blind testing program.

Some commenters expressed concern

about being able to find adulterated

blind specimens. A few comments from

TPAs suggested that they should not

have to send in blind specimens, even

when they submitted more than 2000

specimens in the aggregate, because

doing so should remain the individual

employer’s responsibility.

The Department believes the NPRM

proposed a good balance between

considerations of reducing burdens and

maintaining an effective check on

laboratory performance. We have had

few if any laboratory accuracy problems

over the history of the program, and we

believe that we can continue to ensure

that this pattern continues while

reducing burdens and costs on

participants. We agree that adulterated

and substituted specimens should be

made part of the blind specimen testing

program, and we have consequently

changed the proportions of specimens

in the program to be 75 percent

negative, 15 percent positive, and 10

percent adulterated or substituted. This

is particularly important given the

recent problems at some laboratories

concerning validity testing. Given that

this provision will not take effect until

next August, we think that producers

will have time to market adulterated

and substituted blind specimens.

We believe that any organization that

transmits to laboratories the requisite

number of specimens in the aggregate

should be responsible for participating

in the blind testing program. This is true

no matter whether the organization is an

employer, a C/TPA, or some other

service agent. The structure of the

organization is irrelevant for this

purpose. To decide otherwise would

permit large gaps in the blind testing

program. If 100 employers with 20

employees each are served by a C/TPA,

and the C/TPA does not submit blind

specimens, then no one will submit

such specimens with respect to these

employees, since each of the employers

is too small on its own to be required

to participate. Permitting this gap to

exist would be disadvantageous from

the program integrity standpoint.

We would also point out that C/TPAs,

in virtually every other area of program

administration, assert that they can

perform a multitude of functions for

everyone involved in the program. We

do not see any compelling reason for

looking differently at their involvement

in blind specimen testing.

Section 40.105 What Happens if the

Laboratory Reports a Result Different

From That Expected for a Blind

Specimen?

Some commenters objected to the

proposed requirement for notification of

DOT in the event of a laboratory error,

or to the idea that ODAPC could direct

laboratories to take corrective action.

The main argument of these comments

was that HHS had what they viewed as

exclusive jurisdiction over testing

matters, on which DOT should not

infringe. We have refocused the section

on unexpected blind specimen results.

The Department would always

coordinate closely with HHS on matters

affecting laboratories, as indeed we have

done in drafting this provision. The fact

remains that many MROs and other

participants in the DOT program have

their primary Federal agency

relationship with DOT agencies, and it

makes sense to have them report

problems to DOT. It is also important to

realize that testing laboratories, while

certified by HHS, receive significantly

more specimens as a result of the DOT

program than as a result of the Federal

employee testing program. Under these

circumstances, a DOT role in noting and

helping to correct any laboratory-related

problems affecting the DOT program

seems most appropriate.

Because we are requiring blind

specimens in connection with validity

testing, this section necessarily covers

errors in validity testing.

Section 40.107 Who May Inspect

Laboratories?

In response to comments, we are

clarifying that the employers who may

inspect laboratories are those who use

or are negotiating to use its services for

DOT-regulated testing.

Section 40.109 What Documentation

Must the Laboratory Keep, and for How

Long?

The Department has simplified this

section and acted to reduce paperwork

burdens, as a number of commenters

recommended. All records supporting

test results and those cited in § 40.111

must be kept for two years, unless an

MRO, employer, employee, or DOT

agency representatives requests an

extension within the two-year period

(e.g., for litigation purposes). If no such

request is received, the laboratory may

discard the records.

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79493

Section 40.111 When and How Must a

Laboratory Disclose Statistical

Summaries and Other Information It

Maintains?

The NPRM proposed to reduce

paperwork burdens by reducing the

reporting frequency for this information

from quarterly to semi-annually. A

number of comments supported this

reduction. Other commenters favored

eliminating the requirement altogether,

or at least for small employers, on

burden and cost reduction grounds. We

believe that cutting the reporting burden

in half is a sufficient burden reduction

on this item and that even small

employers will find summarized

information on their workforce’s

participation useful. We underline the

fact that the smallest employers,

laboratories and C/TPAs will not

experience the burden of sending ‘‘nonreports,’’ since there is no requirement

to send a letter saying there is nothing

to report unless specifically requested as

part of a DOT audit. This will further

reduce the paperwork burden of the

rule.

Section 40.113 Where Is Other

Information Concerning Laboratories

Found in This Regulation?

This is a cross-reference section to

inform readers where they may find

other material relevant to laboratories’

participation in the program.

Subpart G—Medical Review Officers

and the Verification Process

Section 40.121 Who Is Qualified To

Act as an MRO?

The Department believes that MROs

play a key role in maintaining a fair and

accurate drug testing program. Ensuring

that MROs are in the best possible

position to play this role requires, in our

view, that they be well trained both in

the substance of drug testing issues and

the rules they are called on to apply. For

these reasons, the NPRM proposed that

MROs participate in a training course

every two years or, in the alternative,

self-certify that they have reviewed and

understand these rules.

Commenters raised a number of

issues. First, some commenters said that

groups of health professionals other

than physicians, like chiropractors,

nurse practitioners, and physicians’

assistants, should be able to be MROs.

They perform other functions like

physicians (e.g., DOT physical

examinations for commercial drivers)

and are qualified to perform this one,

commenters asserted. The Department

does not agree with this assertion. That

other health professionals have some

training similar to that of physicians is

undeniable, but the Department believes

that the variety and depth of expertise

needed to carry out MRO

responsibilities effectively is unlikely to

be found in other health professionals.

There are clearly differences in the level

of training needed to qualify for the

various health professions, and we

believe that only those professionals

with the highest level of training should

play this key role. Being qualified to

perform routine physical examinations,

for example, is not necessarily the same

thing as being able to make capably the

difficult judgment calls that MROs are

called upon to make.

Second, many commenters disagreed

with the proposal to allow selfcertification of training. More formal

training, including a certification

program, was necessary, commenters

said. Commenters pointed to three

existing MRO training and certification

programs as models for what the

Department should require. These have

a five-year retraining cycle, and a

number of commenters thought that five

years, as opposed to two, was sensible.

On the other hand, a smaller number of

commenters opposed additional training

requirements for MROs, saying it would

drive up the cost and difficulty of being

an MRO, and hence reduce the supply

of MROs available to employers.

The Department is modifying this

section in response to these comments.

We are persuaded that MROs, given

their critical role, should not only have

the highest professional credentials to

begin with, but also receive formal

training in the rules and decision

process of their critical role in this

program. Therefore, we are dropping the

self-certification proposal of the NPRM.

We will require MROs to take a formal

training course, like one of the three

national programs currently being

offered. We will also require an

examination administered by a

nationally-recognized MRO professional

certification board. We are not requiring

‘‘certification’’ of MROs, as such,

however. While people who take the

MRO courses typically get a

‘‘certificate’’ from the program, DOT is

not certifying doctors in a way

analogous to the way that the FAA

certificates pilots. We believe that

certification by professional

organizations is beneficial, but we

believe that there are sufficient market

incentives for certification that we do

not need to require it in this rule.

Finally, we are adding a continuing

education requirement to ensure that

MROs keep up with changes and

developments in the field and the DOT

program.

The final rule establishes a phase-in

period for this training requirement. For

example, if a doctor is currently acting

as an MRO, but has not yet had a formal

training course, the doctor would have

until January 2003 to meet the

requirement. This should prevent any

difficulty caused by lack of training sites

or dates convenient for a particular

physician.

Costs for existing MRO training

courses tend to average around $750,

including the examination, and the

courses take a weekend. This low cost

and time commitment suggest that this

training requirement should not dry up

the supply of MROs.

Like other participants, MROs would

have to maintain their own

documentation of training and

qualification, which they must provide

on request to representatives of the

Department and employers and service

agents who are using or negotiating to

use their services.

One issue about which the

Department inquired in the preamble to

the NPRM concerned issues of MRO

work that goes across state lines.

Commenters expressed the concern that

some state medical regulatory

organizations may attempt to assert that

only doctors licensed in a particular

state could perform MRO services with

respect to employees located in that

state. The Department shares these

commenters’ concern. This is a national

program, and MROs often perform their

duties for employees located in many

states. Consequently, this section

specifically provides that a physician

licensed to practice in any jurisdiction

(e.g., a state or province of the United

States, Canada or Mexico, consistent

with NAFTA requirements) and meeting

other MRO requirements is authorized

to act as an MRO with respect to

employees located in any jurisdiction.

We would regard any attempt by a state

medical regulatory organization to limit

the geographic scope of an MRO’s work

as pre-empted under the pre-emption

provisions of DOT agency rules.

Section 40.123 What Are the MRO’s

Responsibilities in the DOT Drug

Testing Program?

There were a few comments on this

section. One commenter liked, and

another disliked, referring to the MRO

as a gatekeeper for the accuracy and

integrity of the process. Another

suggested that the MRO should be an

advocate for the accuracy and integrity

of the process. We have kept the

gatekeeper term and added the idea of

being a program advocate. As other

commenters agreed, independence and

79494 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

impartiality are essential to the MRO’s

role.

One commenter thought that the

NPRM assumed, incorrectly, that MROs

were solo practitioners. This commenter

pointed out that there are MRO

organizations with multiple MROs who

perform drug testing program functions.

We are very aware of this phenomenon,

which is not surprising given the

emphasis on group practice in today’s

health care industry. Nevertheless, each

MRO retains individual responsibility

for his or her actions. Groups don’t

verify test results; individual doctors do.

It is the individual doctor who must

make a decision and sign off on the

result.

One employer organization was

concerned that the NPRM placed in the

hands of MROs tasks that, in its view,

properly belong to the employer, like

providing feedback to collection sites

and laboratories on performance issues.

We have added ‘‘employers’’ to the list

of persons with whom it is appropriate

for MROs to communicate. At the same

time, however, we do not believe that it

is consistent with the independence and

impartiality of the MRO for employers

to limit the contact of MROs with other

parties.

In particular, we believe that no other

party may legitimately attempt to

interfere with the opportunity of an

MRO to communicate with DOT agency

representatives about drug testing

program matters. For this reason, we

have added language specifically

prohibiting anyone from interfering

with an MRO’s access to DOT personnel

or retaliating against an MRO for

communicating with the Department.

We became convinced of the necessity

of this provision, in part, because of an

instance in which an MRO raised an

issue about a decision of a major

transportation employer, who had in

turn been given questionable advice by

a service agent. The MRO brought the

matter to the Department’s attention.

The Department wrote a letter to the

employer correcting its understanding

of the issue in question. The employer

responded by directing the MRO not to

communicate with DOT and

subsequently terminated the MRO’s

services. The Department wants to put

all parties on notice that conduct of this

kind is not permitted by the new

regulation and in future will subject

violators to enforcement action by DOT

agencies, in the case of employers, or

PIE proceedings, in the case of service

agents.

As a number of commenters noted,

since MROs will be involved in

reviewing validity testing results, they

will need to be prepared for the

verification process in adulteration and

substitution situations. This section

now refers to this facet of the MRO’s

duties.

In addition, the rule does not deem

MROs, in working with employees

under this program, to have established

a doctor-patient relationship with them.

Doctors are not diagnosing or treating

employees they encounter in their role

as MROs; they are using their medical

expertise to make decisions in the

context of a forensic program. In the

Department’s view, drug and alcohol

tests are not properly viewed as medical

examinations or procedures,

notwithstanding the involvement of

medically-trained personnel in their

administration.

Section 40.125 What Relationship May

an MRO Have With a Laboratory?

This section is the reciprocal of

§ 40.101, prohibiting improper MROlaboratory relationships. It refers to the

same improper relationships listed in

§ 40.101 and directs MROs to sign a

statement that they have no conflicts of

interest or other improper relationships

with laboratories.

Commenters generally concurred with

this provision, agreeing with the need to

keep MRO and laboratory functions

separate. One commenter said that

MROs should be able to provide a list

of laboratories to customers and

laboratories should be able to refer

customers to MRO certifying

organizations. We do not endorse this

practice, though the names of HHScertified laboratories and groups that

train MROs are matters of public record

that no one can be forbidden from

sharing. Another commenter asked how

the provisions of this section would be

enforced. The answer is through the PIE

process. Another commenter asked that

we specifically prohibit having MROs or

MRO staff within a lab facility. The list

of prohibited relationships in § 40.101

includes this item.

Section 40.127 What are the MRO’s

Functions in Reviewing Negative Test

Results?

Commenters raised two main issues

concerning this section. While some

commenters, mindful of the necessary

role of the MRO in quality control for

the testing process, supported MRO

review of negative test results, most of

those commenting said that the review

requirements were too burdensome. It

was not necessary for MROs to review

10 percent of negative results, they said,

and this would raise costs that would be

passed on to employers. These

commenters appeared to view the

processing of negative results as a

simple administrative task that could

safely be delegated to staff. If MROs

were to review negative results at all,

these commenters suggested, the

amount of review should be reduced

(e.g., to five percent or a numerical

maximum).

Reviewing negative test result records

is an administrative task, to be sure, and

we anticipate that MRO staffs will do

most of the work involved. But quality

control is an important function for

which MROs themselves must remain

responsible. In response to comments,

we will reduce the number of reviews

by MROs to five percent of results,

including all that have required some

corrective action (e.g., to fix a

correctable flaw), to a maximum of 500

results per calendar quarter. This will

reduce the potential burden on MROs,

while retaining their oversight

responsibility.

The second major issue was the

proposed language that required review

of negative results to be done by staff

under the direct personal supervision of

MROs. Some commenters objected to

this language, believing it meant that

MROs would have to be co-located with

all staff and provide face-to-face

supervision. This would be contrary to

common working arrangements of

service agents, they said.

The Department does not intend,

through use of this language, to mandate

that MROs must share the same physical

space with all their staff members at all

times. As commenters noted, direct

personal supervision need not be

physically face-to-face on an all-day,

every day basis. Supervision can also

take place through using a variety of

electronic communications. However,

the direct personal supervision must be

meaningful. It involves personal

oversight of staff members’ work;

personal involvement in evaluation,

hiring, and firing; line authority over the

staff for decisions, direction and control;

and regular contact and oversight

concerning drug testing program

matters. It also means that the MRO’s

supervision and control of the staff

members cannot be superseded by or

delegated to anyone else with respect to

test result review and other functions

staff members perform for the MRO. In

addition, CCFs may not contain

fictitious addresses for MROs, and

MROs must be personally involved with

the review process when a confirmed

positive, adulterated, or substituted

result is received.

There were also some comments

advocating the use of electronic means

of transmitting negative results from

MROs to employers. We agree, and

provide for this in § 40.163. A number

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79495

of comments to this section also touted

transmission of negative results to

employers via C/TPAs, which we permit

in § 40.165 and Appendix F. Some

commenters also supported eliminating

a requirement that the MRO have any

copies of the CCF before verifying a

negative result. We do not believe it is

advisable to make this change, because

it is important that the MRO have the

MRO copy of the CCF. This allows the

MRO to double-check the accuracy of a

result to ensure, for example, that an

employer does not allow someone to

begin work in a safety-sensitive position

on the basis of a mistaken or

misidentified negative result on a preemployment test. Instead, we have

tightened the requirements for

appropriate copies of the CCF to reach

the MRO in a more timely fashion.

Section 40.129 What are the MRO’s

Functions in Reviewing Laboratory

Confirmed Positive, Adulterated,

Substituted, or Invalid Drug Test

Results?

Virtually all the comment in this

section concerned its references to the

stand-down issue. The comments on

this section were essentially the same

with respect to proposed § 40.159, and

we discussed this issue in the

‘‘Principal Policy Issues’’ portion of the

preamble. Since we decided to allow

employers to ask for a waiver to have a

stand-down policy, this section now

tells MROs either to inform the DER that

there is a confirmed laboratory

adulterated, substituted, invalid or

positive test result (if the employer has

a stand-down waiver in place) or to

avoid telling the employer about such a

result, pending verification (if there is

no such waiver in place). Since MRO

review will now apply to adulterated

and substituted results as well as

invalid and positive results, this section

and all those that follow reference all

four kinds of results.

Section 40.131 How Does the MRO or

DER Notify an Employee of the

Verification Process After a Confirmed

Positive, Adulterated, Substituted, or

Invalid Test Result?

Most of the discussion of this section

concerned the proposed requirement,

based on the Department’s current rules

and guidance, that MRO staff may make

initial contacts with employees but not

gather medical information or

information pertaining to a legitimate

medical explanation. A number of

commenters said that staff, especially

medically trained staff like physicians’

assistants and nurses, should be able to

perform these functions. This happens

in the normal course of doctors’ office

and clinic work, they said, and would

make the process less costly and more

efficient. Other commenters thought the

proposal was important for protecting

employees’ rights in the system.

The Department believes that this

situation is distinguishable from the

day-to-day operation of a doctor’s office.

We are talking here about a key function

in protecting the constitutional rights

and livelihoods of employees, a

function that has no parallel in daily

clinical work. Our experience is that, if

employees talk to staff about substantive

matters, they sometimes think they have

talked to the MRO and need not have

further contact with the MRO. They

therefore do not take full advantage of

the protections the rule makes available

for them. We also are concerned that

clinic staff may not have the background

to talk effectively with employees about

legitimate medical explanations for

confirmed positive, adulterated,

substituted, or invalid test results. Staff

can still play a useful role by advising

employees to gather all prescriptions

and other information together so as to

be prepared to have a productive

discussion with the MRO, as well as by

scheduling the discussion with the

MRO.

We agree with commenters who

pointed out that discussions with the

MRO need not be in person. Most MRO

operations use telephone contacts, and

we have no objection to continuing that

practice. We also agree with a

commenter that, in instances where the

MRO has been unable to contact the

employee, MRO staff can contact the

DER to take the next steps in the

process.

The NPRM proposed that the MRO

make at least two attempts to contact the

employee over a 24-hour period. There

was disagreement about this point.

Some union and other commenters

thought the period was too brief, while

some employer and other commenters

thought it was too long. We believe 24

hours is a reasonable middle ground

that will provide a fair chance to contact

the employee to exercise an important

right while not allowing a situation to

drag on interminably.

However, we have increased the

minimum number of attempts to three,

in order to provide a greater chance for

attempts to contact the employee to be

successful. These attempts need to be

separated in time. It would be useless to

call the employee, get no answer, and

call back five minutes later to get no

answer again. The attempts must be

spread reasonably over the 24-hour

period involved. There may also be

circumstances in which the employee

has provided incorrect phone numbers.

If both phone numbers are ‘‘bad

numbers’’ (disconnected, employee not

known at that number), the MRO need

not wait 24 hours to take the next

actions the rules call for, since it would

be futile to do so.

Section 40.133 Under What

Circumstances May the MRO Verify a

Test as Positive, or as a Refusal To Test

Because of Adulteration or Substitution,

Without Interviewing the Employee?

Commenters on this section were

mainly concerned about time frames.

While there was relatively little

disagreement with the idea that the

MRO could verify a test after 72 hours

had passed from an MRO or DER

contact with an employee (one

commenter suggested 48), many

commenters said that 14 days was too

long a time for the MRO to wait before

verifying a test when no one was able

to contact the employee. A number of

these comments suggested 5 or 7 days.

The Department will respond to these

comments by shortening the time period

to 10 days. We do not believe it is

necessary to shorten the period further.

Obviously, if the MRO or DER cannot

contact the employee in that amount of

time, either the employee is not

performing safety-sensitive functions

(e.g., is away on vacation without a

forwarding phone number) or is as

unreachable to be pulled off safetysensitive duties as he or she is with

respect to talking to the MRO. There is

no additional safety risk in either case.

Section 40.135 What Does the MRO

Tell the Employee at the Beginning of

the Verification Interview?

Commenters generally supported this

provision, which tells MROs to inform

employees about the verification

process, what will be expected of the

employee, and about what information

can later be made available to employers

and others. One commenter requested

that MROs make explicit what specific

medications might be reported to

employers. This is potentially a very

comprehensive list, and we do not

believe that this suggestion is practical.

Section 40.137 On What Basis Does

the MRO Verify Test Results Involving

Marijuana, Cocaine, Amphetamines,

and PCP?

One of the important provisions of

this section, which the final rule makes

explicit, is that employees bear the

burden of proof that there is a legitimate

medical explanation for the presence of

these drugs in their specimens. One

commenter asked that we not ‘‘shift’’ the

burden of proof to the employee. There

79496 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

is no ‘‘shift.’’ The employee has always

had this responsibility.

Consistent with similar provisions in

the validity testing context, we are

requiring employees to present their

explanation and supporting evidence at

the time of the verification interview.

The MRO’s staff will already have told

the employee to gather prescription and

other relevant information for this

purpose. This should help to expedite

the verification process. However, if the

employee persuades the MRO that there

is a reasonable basis to believe that the

employee can produce additional

relevant evidence, the MRO can grant

up to five additional days to produce

the evidence. This is not mandatory:

The MRO should grant more time only

if it appears that there is a good reason

to do so.

We agree with one comment that

pointed out that there are no legitimate

medical explanations for the use of PCP.

This is also true of 6AM, a heroinspecific substance found in some opiate

specimens. Section 40.151 now tells

MROs not to accept any medical

explanations for these substances.

The NPRM mentioned that an MRO

could consider the employee’s use of

legally obtained foreign medication.

One commenter objected to this

provision. We believe it is appropriate

to consider the fact that an employee

obtained medication legally in a foreign

country, when medically appropriate,

even if that medication is not legally

available in the U.S. To do otherwise

could penalize legal, innocent conduct.

We have adopted, as part of the rule

text, the principles underlying the

Department’s existing guidance on the

foreign medications issue.

We intend that, under this provision,

MROs have broad discretion to

determine whether the use of

medications legally obtained within a

foreign country should be viewed as a

legitimate medical. In doing so, MROs

must exercise their best professional

judgment. MROs are neither required to

find a legitimate medical explanation in

any particular case nor prohibited from

doing so (except to the extent that one

of the principles set forth in this section

requires the MRO to find that there was

not a legitimate medical explanation).

One of the reasons for the prominent

position given MROs in the DOT drug

testing program is precisely that we

believe trained MROs are the bestequipped persons in the program to

make these difficult medical judgment

calls. We are confident that MROs will

be thoughtful in considering the issues.

The rule articulates three principles

for MROs use in exercising their

discretion. First, there can be a

legitimate medical explanation only

with respect to a medication that is

legally obtained in a foreign country.

Second there can be a legitimate

medical explanation only with respect

to a substance that has a legitimate

medical use. Even if one obtains a

substance abroad legally, it cannot form

the basis of a legitimate medical

explanation if it does not have a

legitimate medical use. For example,

drugs of abuse like heroin, marijuana,

and PCP have no legitimate medical

uses, and they cannot form the basis of

a legitimate medical explanation in any

case. Likewise, use of substance

which—if obtained in the United

States—would not form the basis of a

legitimate medical explanation (e.g.,

hemp products, coca leaf teas) cannot

form the basis of a legitimate medical

explanation when obtained abroad.

Third, a foreign medication can form

the basis of a legitimate medical

explanation only if it is used

consistently with its proper and

intended medical purpose. When

someone uses a medication, the person

has an obligation to use the substance

for its appropriate purpose and in

keeping with medical instructions for its

use. In addressing this issue, the MRO

should look at a number of factors. Did

the employee have a genuine medical

need for using the substance (e.g., an

acute condition that arose while the

employee was in the foreign country)?

Did the employee use the medication for

an appropriate medical purpose (e.g., as

opposed to using a medication intended

for one purpose for a different, and

inappropriate, purpose)? Is the quantity

of the substance in the individual’s

specimen consistent with its proper

medical use?

In applying these principles, it is very

important for the employee to provide

the MRO with adequate documentation.

Travel documentation (visa, passport

stamps, airline tickets, etc.) can help to

check an employee’s assertion that he or

she was in the foreign country in

question at the time he or she said the

medication was obtained and/or

consumed. Especially where a

prescription drug is involved,

discussions with a foreign physician or

pharmacist are relevant to confirming

the prescription for the foreign

medication and the reason for it. It is

important to note that, in some cases,

drugs may be prescribed for purposes in

foreign countries different from the

purposes for which the medications are

prescribed in the U.S. In the case of any

foreign medication, the MRO should

review documentation of purchase.

Ultimately, it is the employee’s burden

to produce this information, though the

MRO may need to be involved in some

aspects of the effort, such as discussing

medications with a foreign doctor.

In assessing situations in which an

employee obtains a medication abroad

and consumes it after returning to the

U.S., the MRO should take special care

to ensure that the employee is using the

medication for its intended, appropriate

medical purpose. Import and use of

some medications in the U.S. may be

inconsistent with U.S. drug laws or

Customs rules. This heightens the

concern that an employee who is using

such a medication in the U.S. may not

be doing so consistent with its

appropriate, intended medical purpose.

In particular, routine or frequent use of

such a medication in the U.S., as

distinct from a one-time or infrequent,

inadvertent, or emergency use of the

medication, may support an inference

that an individual is not using the

medication for its intended, appropriate

medical purpose. If an employee should

have consulted with a U.S. physician

before using a foreign medication in the

U.S., it can be relevant for the MRO to

ask whether such a consultation took

place. As a general matter, we view the

U.S. use of foreign medication as more

problematic than the use of the

medication abroad, and we advise

MROs to be more conservative in their

determinations where U.S. use is

involved.

As in cases involving drugs obtained

domestically, verification of a test as

negative does not end the MRO’s job. If

use of a substance, even though not a

violation of DOT agency drug and

alcohol testing rules, creates safety or

fitness-for-duty problems, MROs have a

mandate to report this information to

employers (see § 40.327). An employee

may be medically unfit for safetysensitive duties because of the use of a

legal medication, foreign or domestic.

Section 40.139 On What Basis Does

the MRO Verify Test Results Involving

Opiates?

Most of the discussion on this section

concerned the use of the 15,000 ng/mL

level of opiates in a specimen for

shifting the burden of proof from the

MRO (who in most opiate cases must

show clinical evidence of unauthorized

use) to the employee to show a

legitimate medical explanation, as is the

case in § 40.137 for other drugs. As

noted in the preamble to the NPRM (see

64 FR 60980; December 9, 1999), the

Department has good reason to believe

that this is an appropriate level (i.e., one

high enough to avoid imposing an

unfair burden on people who eat poppy

seeds or otherwise engage in legal

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79497

activities for which there are not

legitimate medical explanations).

Some commenters appeared confused

about the relationship of this threshold

to the 2000 ng/mL cutoff for a confirmed

positive test result. The two are

different, and they are used for different

purposes. The latter establishes a

confirmed positive test; the former

establishes that the employee, rather

than the MRO, has the burden of proof

in the verification process. In one

Canadian commenter’s example,

codeine medications are legally

available in Canada, and might produce

test levels in excess of 15,000 ng/mL. In

such a case, the employee would have

the burden of proof with respect to a

legitimate medical explanation, which

the employee could meet through

showing that he or she had used a legal

over-the-counter medication.

When an employee cannot establish a

legitimate medical explanation for

opiate levels (morphine or codeine)

above the 15,000 ng/mL, then the MRO

would verify the test positive. There

would be no need for the MRO to find

clinical evidence of unauthorized use.

A commenter suggested, and we

agree, that the MRO or other physician’s

encounter with an employee to

determine if there is clinical evidence of

unauthorized opiate use is better styled

an ‘‘examination’’ than an ‘‘interview,’’

and we have changed the language

accordingly.

The Department notes that a situation

could arise in which the primary

specimen is positive for opiates and 6–

AM. The MRO verifies the test as

positive, without determining whether

there is a legitimate medical explanation

or clinical signs of unauthorized use,

since these steps are not necessary when

a specimen is positive for 6–AM. The

split specimen reconfirms the presence

of opiates but not the presence of 6–AM.

In this case, the test would not be

cancelled. Rather, the MRO would take

additional verification steps. If the

amount of morphine or codeine in the

primary specimen were 15,000 ng/mL or

more, the MRO would ask the employee

to provide information on any legitimate

medical explanation there might be for

the presence of the opiates in the

specimen. If the amount of morphine or

coedine were less than 15,000 ng/mL,

the MRO would examine the employee

for clinical signs of unauthorized use or

refer him or her to another physician for

this purpose. The MRO would then

make a decision about whether to verify

the result as positive. The MRO would

make this decision without reference to

6–AM, since the specimen had failed to

reconfirm for 6–AM.

Section 40.141 How Does the MRO

Obtain Information for the Verification

Decision?

There were few comments to this

section. One that we adopted suggested

that in addition to reviewing evidence

on its face, the MRO should take all

reasonable and necessary steps to verify

the authenticity of the evidence. We

have deleted a provision authorizing the

MRO to tell the laboratory to conduct a

reanalysis of the primary specimen.

Because this rule no longer provides for

single specimen collections, we believe

that this language is superfluous.

Reanalysis of the primary specimen is

no longer authorized.

Section 40.145 On What Basis Does

the MRO Verify Test Results Involving

Adulteration or Substitution?

This section adds MRO review

provisions concerning the results of

validity tests. The basic policy issue of

MRO review for validity testing was

discussed in the ‘‘Principal Policy

Issues’’ section of the preamble, which

also describes the provisions of these

sections. As noted above, MRO review

of validity testing results will begin 30

days after the publication of this rule.

One point we want to emphasize is

that it is not enough for an employee to

come up with a reason that allegedly

accounts for the result (e.g., a medical

condition, personal characteristics,

proximity to a chemical). To meet his or

her burden of proof, the employee must

demonstrate a link between the alleged

reason and the ability to physiologically

produce the laboratory result obtained.

For example, if an employee shows he

has medical condition X, then he must

also show a medical/scientific basis for

getting from X to a creatinine result

below 5 and a specific gravity below

1.001. If the employee shows he had

topical exposure to chemical Z, he must

also demonstrate medical/scientific

evidence that topical exposure to Z in

the concentration he experienced leads

to the physiological production of the

levels of Z in his specimen that the

laboratory found. Any such evidence

must meet medical/scientific criteria for

controls, methodology etc., in order to

have credibility.

In any case in which the MRO cancels

an adulterated or substituted test result

because the employee has established a

legitimate medical explanation, the

MRO must make a written report to

ODAPC. The purpose of this report is to

permit ODAPC and HHS to examine the

circumstances. This examination could

lead to additional guidance to MROs or

laboratories concerning the matters that

led to the cancellation. ODAPC would

not, in such a case, act as a ‘‘court of

appeals’’ that would overturn the results

of the MRO review process.

Under the final rule, the MRO

reviewing an adulterated or substituted

test result could direct the employee to

obtain, within 5 days, a further medical

evaluation from someone with expertise

in the medical issues raised by the

employee’s explanation. This individual

could be a specialist in a particular field

of practice, but need not be. What is

important is that the referral physician

have enough expertise to deal

effectively with the particular issues in

the case.

The Department is aware that, in

some cases, it may be difficult for an

employee to secure, on his or her own,

an appointment for this evaluation in a

short period of time. Consequently, the

Department does not regard it as a

refusal to test if the employee is unable,

after making good faith efforts, to get the

appointment within the 5-day period.

However, the MRO and the employer

should do everything feasible to assist

the employee in finding and getting an

appointment with an appropriate

physician.

Section 40.149 May the MRO Change a

Verified Positive Drug Test Result or

Refusal To Test?

This provision is based on proposed

§ 40.161. There were relatively few

comments. A small number of

commenters suggested that the

employer should be able to change an

MRO’s action the employer believed to

be erroneous, perhaps by referring the

matter to another MRO for a second

opinion. We do not believe that it would

be advisable to authorize this sort of

forum shopping. Under the new

regulation, MROs will be even better

trained in their duties. It would erode

the finality of MRO’s decisions and the

protections the MRO system affords to

employees to allow employers a second

bite at the apple.

Some commenters also believed the

60-day period during which an MRO

could reverse a decision he or she had

made was too long. One commenter

thought that 14 days was a more

reasonable time period. The point of

this provision is to allow employees to

present evidence that was not originally

available. There need be no rush to

foreclose this opportunity, which has no

adverse safety implications, since the

MRO will have already communicated

the verification decision to the

employer, who will have removed the

employee from safety-sensitive duties.

We will leave this provision unchanged,

except to add a reference to adulteration

and substitution cases.

79498 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

Here is a hypothetical case illustrating

how the provision would work, in

concert with the five-day extension

provision of the §§ 40.137 and 40.145.

The MRO interviews the employee, who

says she has a legitimate medical

explanation. She asks for, and receives,

a 3-day extension to find evidence of the

explanation, but is unable to do so. The

MRO verifies the test as a refusal

because of adulteration or substitution.

The MRO reports the verified refusal

result to the employer, who removes the

employee from safety-sensitive duties.

Six weeks later, she returns to the

MRO with additional data, including a

study performed by the referral

physician, acceptable to the MRO, who

she has retained. The study, performed

under carefully controlled conditions,

shows that the employee was able to

replicate the laboratory result through

physiological means. The MRO

determines that this is a legitimate

medical explanation and, after

discussing the matter with ODAPC,

reverses the original verification result.

At this point, the employee no longer

has an obligation to complete the returnto-duty process before working again in

a safety-sensitive position.

Section 40.151 What Are MROs

Prohibited From Doing as Part of the

Verification Process?

This section is based on § 40.143 of

the NPRM. There was little comment. A

few comments recommended that MROs

should be able to consider evidence

extrinsic to the testing process, such as

procedural errors not reflected on the

CCF, tests of additional specimens (e.g.,

a hair test), or use of ‘‘medical

marijuana’’ in a state with a law

authorizing such use. The Department is

not adopting these suggestions, which

would authorize collateral attacks on

the validity of the testing process. This

regulation prescribes the testing process;

if the procedures in a given test meet

this part’s requirements, that is enough

to make the test valid. The MRO should

not go beyond the rule’s requirements to

accept other reasons to cancel a test.

We do not believe it is appropriate to

place MROs in the position of having to

decide factual disputes between

employees and collectors about what

did or did not occur at the collection

site (e.g., allegations that the collector

left the area or left open urine

containers where other people could

access them) or about whether someone

was properly selected for testing.

Therefore, this section directs MROs not

to become involved in issues extrinsic

to the documents in reviewing the CCF.

We do not intend, through this

provision, to preclude MROs from

taking action to cancel a test if the MRO

determines that a fatal flaw has occurred

in the testing process.

We have, as some commenters

suggested, added provisions related to

validity testing. Certain substances

cannot be produced physiologically in

urine, and urine cannot have a zero

creatinine content. Likewise, there is no

legitimate medical explanation for PCP

or 6–AM. The rule specifies that MROs

cannot find that a legitimate medical

explanation exists in these

circumstances. Following a

commenter’s suggestion, we have also

added coca leaf tea explanations to the

same category of explanations (along

with use of hemp products) that MROs

may not accept.

Section 40.153 How Does the MRO

Notify Employees of Their Right to a

Test of the Split Specimen?

Commenters said that if, as § 40.145 of

the NPRM proposed, MROs tell

employees with verified positive,

adulterated, and substituted tests (1)

that they have a right to a test of the

split specimen if they make a timely

request, and (2) that they are not

required to pay for the test from their

own funds before the test takes place,

then employees will frequently request

tests of split specimens. This, in the

view of a significant number of

commenters, would be a bad thing: Few

split specimens fail to reconfirm and

testing them is an expensive annoyance

that merely serves to delay the

inevitable. On the other hand, as one

commenter suggested, requiring

advance payment from the employee’s

own funds would have the benefit of

eliminating most split specimen tests,

since they are most often a ploy used by

a guilty employee in the hopes that the

split is unavailable for testing or that the

specimen will not reconfirm.

The problem with these commenters’

analysis is that a test of a split specimen

is a right guaranteed to employees by

the Omnibus Transportation Employee

Testing Act. We agree with commenters

that if we do not make employees aware

of this right and permit employers to

financially deter employees from

exercising it, then fewer employees are

likely to request a test of the split

specimen. However, we must disagree

with the proposition that reducing the

frequency of requests of a test of the

split specimen is an appropriate

objective.

When Congress guarantees a right to

employees (and we believe we must

treat all DOT-regulated employees in

our program alike, even if they are not

covered by the Omnibus Act), our

obligation as a Federal agency is to

faithfully execute that legislative

decision. The statute provides a series of

other protections to employees as a

matter of right, such as the use of an

HHS-certified laboratory and resort to

MRO review for the five HHS drugs. An

employer could not say that employees

could have their specimen tested at an

HHS laboratory only if they paid in

advance a higher price to have their

specimen tested there instead of a local

hospital. Nor could an employer say

that it would make MRO review

available only if the employee paid in

advance for the MRO’s services. The

same rationale applies to a test of the

split specimen. When the statute and

rule say that a certain procedure must

be made available to an employee, then

the employer is responsible for making

it happen.

Through collective bargaining or

subsequent attempts at securing

reimbursement, an employer may seek

to have the employee ultimately pay

part or all of the cost of a split

specimen. But when the employee with

a verified positive, adulterated, or

substituted test result makes a timely

request for a test of the split specimen,

it is required that the test take place,

and this requirement cannot be made

contingent on advance payment by the

employee. The Department will retain

its NPRM language on this point. (This

approach is consistent with the

Department’s longstanding

interpretation of the current rule.)

Another issue in the comments was

how to define ‘‘timely.’’ The NPRM, like

the present rule, says the right to a test

of the split specimen is triggered if the

employee makes the request within 72

hours of being notified by the MRO of

a verified positive test. On request of a

number of commenters, we are making

explicit that it is the notification of the

verified test result that starts this time

period running. Some commenters

pointed out that RSPA would have to

change its rule (which currently permits

up to 60 days for such a request) to be

consistent with this provision. RSPA

will propose such a change as part of its

conforming amendments to this rule.

Employers also asked whether they

may take action during this 72-hour

period. In fact, employers must remove

employees from safety-sensitive duties

as soon as they are notified of a verified

positive, adulterated, or substituted test

result. In addition, employers are free to

take personnel action once they receive

the verified result, although we believe

it would be wise to avoid taking final

action (e.g., termination) until the 72

hours are up or, where the employee

requests a test of the split specimen,

until the MRO reports the second

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79499

laboratory’s split specimen test result to

the employer. Nothing requires the

employee to be in paid status during

this period, in any case.

A number of commenters noted that

MROs sometimes authorize tests of the

split specimen well after the 72-hour

period has elapsed (e.g., weeks or

months later). Nothing in the rule

precludes an MRO from doing so.

However, an employee has a right to a

test of the split specimen only if he or

she requests it within 72 hours. The

employee cannot insist on having the

split specimen tested after that time,

and the employer is not obligated,

financially or otherwise, to make the

test happen.

A few commenters suggested that the

request for a test of the split specimen

should be made in writing. It seems to

us that a careful employee would make

a written request, in order to have his

timely request on the record. But we do

not think it is necessary to require this

action. Another commenter thought that

the rule should not direct the MRO to

tell employees that DNA or other tests

are not authorized. The Department

believes that this provision is beneficial

as a means of avoiding unnecessary

requests for these tests, and we have

retained it.

Section 40.155 What Does the MRO Do

When a Negative or Positive Test Result

Is Also Dilute?

This section is based on proposed

§ 40.147 of the NPRM. There was little

comment on this section, most of which

concerned the issue of whether a dilute

specimen should be an occasion for a

recollection under direct observation.

Such a recollection is not necessary in

the case of a test result that is both

positive and dilute. For a test that is

both negative and dilute, we have

decided (see § 40.197(b)) to allow the

employer the discretion to conduct an

immediate recollection, but not under

direct observation, since there can be

many innocent reasons for a dilute

specimen. This is a change from the

existing rule, which permitted tests

under direct observation on the next

occasion when the individual would be

tested (e.g., in the random program).

Section 40.159 What Does the MRO Do

When a Drug Test Result Is Invalid?

This section is based on § 40.151 of

the NPRM. Consistent with HHS

guidelines, we are using the term

‘‘invalid’’ rather than ‘‘unsuitable for

testing’’ to describe such test results.

There were a variety of comments on

this section. Some commenters thought

we should treat invalid tests as refusals

to test, the same way we treat

adulterated and substituted tests.

Another commenter thought it would

save time and effort if we simply

cancelled invalid tests, with an

unannounced recollection under direct

observation, rather than going through

the MRO inquiry process proposed in

the NPRM.

We believe that the Department chose

a reasonable middle ground in the

NPRM, and we will use this approach

in the final rule. When an adulterant has

not identified, it has not been

conclusively shown that the employee

has tampered with the specimen.

Recollection under direct observation is

an appropriate response to the suspicion

of tampering that an invalid result

raises. On the other hand, there may be

medical reasons for an invalid result.

Where these exist, it would be unfair to

impose a directly observed collection on

the employee.

A commenter suggested that, when an

employee admits to adulterating or

substituting a specimen, the MRO get a

written statement from the employee or

make his own contemporaneous written

statement of the employee’s admission.

We think that having the MRO

document such admissions is a good

idea, and we have added it to paragraph

(c).

Section 40.161 What Does the MRO Do

When a Drug Test Specimen Is Rejected

for Testing?

This section is based on § 40.155 of

the NPRM. Most comments were to the

effect that it was unnecessary to have

the MRO investigate the reason for the

rejection, which commenters said was

usually obvious. In response, we have

removed this requirement and

simplified this section. It now just

recites the paperwork steps the MRO

follows when he or she receives a

rejected result.

This section no longer calls for a

recollection following a rejected result.

There does not seem to be any strong

reason for requiring a recollection

because of what, in most cases, is an

administrative error. Of course, in

situations (e.g., pre-employment) where

a negative test result is required, there

will have to be another test in order to

attempt to obtain the negative result.

Section 40.163 How Does the MRO

Report Drug Test Results?

Section 40.165 To Whom Does the

MRO Transmit Reports of Drug Test

Results?

Section 40.167 How Are MRO Reports

of Drug Results Transmitted to the

Employer?

These sections are all based on

proposed § 40.157. We split the

proposed section into three parts to

make it easier to understand. The

greatest number of comments on the

proposed section concerned the use of

C/TPAs as intermediaries to transmit

results from MROs to employers. We

discussed this issue in the ‘‘Principal

Policy Issues’’ portion of the preamble

and incorporated our decision in

§ 40.345. Section 40.165 of the new rule

references this decision, by saying that

the MRO transmits results either to the

DER or to a C/TPA acting as an

intermediary. We emphasize that it is

the employer’s choice that determines

whether the MRO transmits the

information directly or permits a C/TPA

to act as an intermediary.

A number of comments concerned the

electronic transmission of results (e.g.,

by fax or secure computer link).

Electronic signature issues were also

raised in this context. The Department’s

advisory committee will take up these

issues in greater detail. For now, we will

retain the NPRM language that

telephone contact is the preferred means

for transmitting non-negative results.

We also note that one commenter

appeared to misunderstand proposed

§ 40.157(b)(3), which has become

§ 40.167(c)(3) in the final rule. We do

not require the MRO’s verbal report to

include all the points required in the

documentation of the report, which

must follow the verbal report. We have

also decided to delete the information

item concerning the address of the

collection site, because we do not

believe it is necessary for this report.

Some commenters felt that the report

format was too complex and would lead

to practical difficulties. In connection

with the new CCF, we have simplified

these requirements. All reports can be

made on a stamped (negatives) or signed

(all other results) copy of Copy 2 of the

CCF. Otherwise, the MRO must

compose a letter with several

information items for each result. We

prefer that MROs use copies of Copy 2

of the CCF for this purpose, which will

result in generating much less

paperwork.

79500 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

Section 40.169 Where is Other

Information Concerning the Role of

MROs Found in This Regulation?

This is another in the series of

sections providing, for readers’

convenience, references to other

sections of the regulation that concern,

in this case, the role and activities of

MROs.

Subpart H—Split Specimen Tests

Section 40.171 How Does an Employee

Request a Test of a Split Specimen?

There were few comments on this

section. A number of commenters

wanted to require that requests for tests

of split specimens be in writing. One

reason given for this request was that

some employees, if the split specimen

test reconfirmed, would deny asking for

the test when the employer asked for

reimbursement. We do not think it

necessary to require these requests to be

in writing, which in some instances

could delay or burden the employee’s

right to have the split specimen retested.

However, so that there is a written

record of the request, the NPRM and

this final rule direct MROs to document

the date and time of the employee’s

request.

Section 40.173 Who Is Responsible for

Paying for the Test of a Split Specimen?

This section is related to the provision

concerning payment for split specimen

tests in § 40.153, and commenters took

very similar positions on the issues. Not

surprisingly, unions and some service

agents liked the proposal better than

employers. The Department’s rationale

for incorporating this provision in the

final rule is essentially the same as

discussed under § 40.153 above.

Employers did want assurance that they

could seek reimbursement from

employees, and paragraph (c) of both

the NPRM and final rule makes that

point clear. We added an example of

how employers could ensure that testing

occurs on time (establishing accounts

with laboratories, which they could do

on their own or through a C/TPA).

Section 40.175 What Steps Does the

First Laboratory Take With a Split

Specimen?

There were few comments concerning

this section. Some commenters asked

that tests be cancelled when a split

specimen was unavailable. For reasons

discussed above, the Department

believes it is better to test the primary

specimen in such cases. Some

commenters addressed proposed

§ 40.175(c), which we have deleted

because it duplicated laboratory

procedure matters in HHS guidance.

Laboratories will follow this HHS

guidance with respect to specimen

retention requirements. Commenters

asked for clarification of who gets to

choose the laboratory that tests the split

specimen. This is an issue on which the

Department does not have a position.

We are satisfied as long as the parties

use an HHS-certified laboratory.

Section 40.177 What Does the Second

Laboratory Do With the Split Specimen

When It Is Being Tested To Reconfirm

the Presence of a Drug or Drug

Metabolite?

Section 40.179 What Does the Second

Laboratory Do With the Split Specimen

When It Is Being Tested To Reconfirm

an Adulterated Test Result?

Section 40.181 What Does the Second

Laboratory Do With the Split Specimen

When It Is Being Tested To Reconfirm

a Substituted Test Result?

These sections are all based on

proposed § 40.177. Most of the

comments on proposed § 40.177

concerned the addition of validity

testing to the split specimen portion of

the program, discussed in greater detail

in the ‘‘Primary Policy Issues’’ portion

of the preamble.

Existing HHS guidance (Program

Documents 35 and 37) establish criteria

for testing of the primary specimen for

adulteration and substitution. These are

the criteria referenced in §§ 40.93 and

40.95. These Program Documents do

not, on their face, apply to testing of the

split specimen. HHS is planning to

incorporate split specimen testing

criteria for adulteration in forthcoming

mandatory requirements for validity

testing. Pending completion of this

formal HHS issuance, and because we

believe it is important to begin split

specimen testing in the validity testing

program as soon as possible, the

Department in §§ 40.179 and 40.181 is

requiring that the split specimen meet

exactly the same criteria as the primary

specimen in order to be considered

reconfirmed. These criteria already exist

in HHS guidance (Program Documents

35 and 37) and have a sound technical

basis. When HHS issues its final

mandatory requirements for split

specimen tests in adulteration and

substitution cases, the Department will,

if necessary, amend these provisions to

refer to the HHS issuance.

Section 40.183 What Information Do

Laboratories Report to MROs Regarding

Split Specimen Results?

This section is based on proposed

§ 40.181 of the NPRM. There were no

substantive comments. We have

adopted the section as proposed, except

that we have added notations applicable

to split specimen tests in adulteration

and substitution situations. We also

clarified that laboratories must sign and

date the appropriate CCF copy.

Section 40.185 Through What Methods

and to Whom Must a Laboratory

Transmit Split Specimen Results?

This section is based on proposed

§ 40.179 of the NPRM. Comments

focused on two issues: the use of

electronic means of transmission and

use of service agents as intermediaries

between laboratories and MROs. In

response to comments favoring greater

use of electronic means, the final rule

will permit results to be sent by

electronic image, as well as other

means. However, for the same reasons

applicable to transmission of primary

specimen test results, we will not

permit C/TPAs to receive split specimen

results from laboratories.. Laboratories

must promptly send split specimen

results directly to MROs.

Section 40.187 What Does the MRO Do

With Split Specimen Laboratory

Results?

This section is based on proposed

§ 40.183 of the NPRM. Some

commenters objected to a retest under

direct observation as the consequence of

a failure to reconfirm due to the

unavailability of the split specimen for

testing. As noted above, this situation

involves strong evidence of a violation

of the rules (e.g., a verified positive test),

with the test being cancelled only

because of a process problem (e.g., the

split leaked away). In this situation,

there is a stronger than usual incentive

for the employee to attempt to beat the

next test, hence the need for direct

observation on the recollection.

The Department deleted proposed

§ 40.185, concerning retests of single

specimen collections, since all

collections under the new rule will be

split specimen collections.

Section 40.189 Where Is Other

Information Concerning Split

Specimens Found in This Regulation?

This is another in the series of crossreference sections designed to help

readers find related material.

Subpart I—Problems in Drug Tests

Section 40.191 What Is a Refusal To

Take a DOT Drug Test, and What Are

the Consequences?

If an employee declines to take a drug

test or takes a number of other actions

that obstruct the drug testing process,

the employee is deemed to have refused

to test. For the most part, the

consequences of a refusal are the same

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79501

or more severe as for any other violation

of DOT agency drug and alcohol

regulations.

Commenters generally agreed with the

list of actions in this section that

constitute a refusal to test. One

commenter wanted refusals on non-DOT

tests to count as refusals under this part.

They cannot, because this part does not

require anyone to take a non-DOT test.

A few comments also urged use of

alternative testing technologies, such

hair testing and on-site testing, in

potential refusal situations. The

Department will defer to HHS on

alternative testing technology issues.

HHS has not yet authorized these

approaches to testing. We have added a

specific reference to verified adulterated

or substituted test results as a ground for

determining that an employee has

refused to test.

Section 40.193 What Happens When

an Employee Does Not Provide a

Sufficient Amount of Urine for a Drug

Test?

This is the so-called ‘‘shy bladder’’

provision of the rule. The proposed

section would keep the core of the

Department’s current shy bladder

procedures in place, and commenters

did not question the direction of this

provision. Commenters did address a

number of specific issues concerning

the section. Some commenters wanted

to specify that the physician performing

an evaluation of potential medical

reasons for a shy bladder situation be a

urologist or other specialist, on the

theory that a non-specialist was not as

well equipped for this function. The

Department agrees, and, in parallel with

the language concerning MRO review of

adulteration and substitution

provisions, the final rule calls for the

use of a licensed physician with

expertise in the medical issues

surrounding a failure to provide a

sufficient specimen.

Commenters disagreed about who

ought to select the physician for this

evaluation. Some said the referral

physician should be acceptable to the

employer. Others said the referral

physician should be acceptable to the

employee. We take the view that the

rule should not specify who makes the

selection of the referral physician, but

we do think that he or she should be

acceptable to the MRO. The MRO is in

a better position than either the

employee or the employer to determine

if a particular referral physician is

appropriate to this task.

Under the final rule, the an employee

in a shy bladder situation would be

directed to obtain within 5 days, a

further medical evaluation from

someone with expertise in the medical

issues raised by the employee’s

situation. This physician could be a

specialist (e.g., a urologist), but need not

be. What is important is that the referral

physician have sufficient expertise to

deal effectively with the medical issues

in the employee’s case.

The Department is aware that, in

some cases, it may be difficult for an

employee to secure, on his or her own,

an appointment for this evaluation in a

short period of time. Consequently, the

Department does not regard it as a

refusal to test if the employee is unable,

after making good faith efforts, to get the

appointment within the 5-day period.

However, the MRO and the employer

should do everything feasible to assist

the employee in finding and getting an

appointment with an appropriate

referral physician.

Commenters raised in this context the

issue of whether a refusal to drink fluids

in a shy bladder situation should

constitute a refusal to test. We do not

believe that a refusal to drink fluids

should be considered a refusal to test,

and we have incorporated this view into

the text of this section.

Some commenters suggested that,

during the five days that may elapse

between an employee’s provision of an

insufficient specimen and the

determination of whether this

constitutes a refusal to test, the

employee should be stood down from

performing safety-sensitive functions.

We are not adopting this suggestion.

Until and unless a refusal is determined

to have occurred, there is no evidence

of violation of the rules on which to

base a temporary removal from

performance of safety-sensitive duties

(unlike the situation under a standdown waiver, where there is the

evidence of a confirmed positive test).

A few comments questioned the

three-hour waiting/fluid consumption

period following an employee’s

provision of an insufficient specimen.

One comment said blood should be

drawn after two hours. Other comments

said it made more sense to go

immediately to an alternative specimen,

such as saliva or hair. We believe that

the three-hour period is by now well

established in the DOT program, and

comments did not make a compelling

case for changing it. As noted above, we

are waiting for HHS action before

making any further decisions

concerning alternative specimens.

We incorporated in this section an

existing DOT interpretation concerning

psychological conditions alleged as

reasons for a failure to provide a

sufficient specimen. The meaning of

this interpretation (see paragraph (e)) is

that to be regarded as a pre-existing

psychological disorder, it is not

necessary that the condition be

diagnosed before the time of the test, but

the symptoms have to have been

medically documented before the time

of the test. For example, an individual

may have brought urination problems to

the attention of his urologist over a

period of time, but the urologist did not

enter a specific diagnosis of a

psychological disorder into the medical

records. In this situation, the examining

physician has the discretion to

determine that there was a pre-existing

psychological condition, if the

physician is convinced that the

medically documented symptoms

support such a diagnosis.

Section 40.195 What Happens When

an Individual Is Unable To Provide a

Sufficient Amount of Urine for a PreEmployment or Return-to-Duty Drug

Test Because of a Permanent or LongTerm Medical Condition?

This section is intended to address a

rare, but difficult, issue that may arise

in these types of testing. In a preemployment or return-to-duty test, an

employee who is not now performing

safety-sensitive duties must have a

negative test result in order to begin or

resume performing safety-sensitive

duties. In a ‘‘shy bladder’’ situation, if

there is an adequate medical reason for

the inability to provide a sufficient

specimen, the test result is cancelled,

not negative. If a permanent or longterm medical condition is the cause of

the inability to provide a sufficient

specimen, the employee might never be

physically capable of obtaining a

negative result. This could be very

unfair to the employee, and it could

raise Americans with Disabilities Act

issues as well.

Some commenters expressed the view

that this provision should apply to other

types of testing as well (e.g., random).

We do not believe it is necessary to do

so, because employees in these

situations do not need a negative test

result to perform safety-sensitive

functions. A cancelled test is not a

violation of DOT rules that compels

employers to remove employees from

safety-sensitive duties.

In response to a comment, we added

language that the MRO can conduct, or

cause to be conducted, the further

medical evaluation the section requires.

We have also clarified that, as part of

this evaluation, the physician may use

alternative testing methods, including

but not limited to blood testing, to help

determine whether the employee shows

clinical evidence of drug abuse.

Particularly given that we do not apply

79502 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

this procedure to random testing, we do

not agree with a suggestion that an

individual covered by this section

should be taken out of the random

testing pool. Doing so would also affect

the probability that other individuals

would be selected for testing. As in

other situations calling for medical

evaluations, the rule requires that the

physician conducting the evaluation be

acceptable to the MRO, rather than to

the employer or employee.

Under this section and § 40.193, the

referral physician reports to the MRO

the basis for any conclusion that the

individual has a permanent, long-term

disability that prevents providing a

sufficient specimen. However, for

privacy reasons, neither the referral

physician or the MRO passes on to the

employer any information about the

nature of the disability. The employer is

simply told that there is a permanent,

long-term condition.

We have not included similar

language in the rule concerning alcohol

testing, because pre-employment

alcohol testing is not mandatory. In the

rare situation in which an employee is

required to have a negative alcohol test

in a return-to-duty or follow-up test

situation, and could not produce

sufficient breath because of a

permanent, long-term disability, we

would apply the reasoning of this

section to that situation.

Section 40.197 What Happens When

an Employer Receives a Report of a

Dilute Specimen?

This section is based on §§ 40.147(a)

and 40.159(d) of the NPRM. The NPRM,

like the existing rule, would have given

employers discretion to use direct

observation the next time the employee

was selected for testing (e.g., in random

testing). Comments on this issue and the

Department’s responses are discussed

under ‘‘Collection Issues’’ in the

‘‘Principal Policy Issues’’ portion of this

preamble. It should be noted that,

unlike the existing rule and the NPRM,

this provision authorizes a new

collection immediately following a

negative-dilute result, rather than on the

next occasion when an employee is

selected for testing. This recollection is

not conducted under direct observation.

Section 40.199 What Problems Always

Cause a Drug Test to be Cancelled?

This section, listing ‘‘fatal flaws’’ that

invariably result in the cancellation of a

test, is based on § 40.197 of the NPRM.

The list of fatal flaws in the final rule

is somewhat different from that in the

proposed rule. Proposed paragraph (b),

concerning the lack of a specimen ID

number, is really an instance of the flaw

cited in paragraph (a), a mismatch

between the specimen ID numbers on

the specimen bottle and the CCF. The

former is included in the latter, so we

have deleted the proposed paragraph

(b). Consistent with HHS guidelines, we

have added a new paragraph (b),

concerning a situation in which the

printed collector’s name and collector’s

signature are both missing. This

section’s list of fatal flaws is now

consistent with the HHS list of fatal

flaws.

A few comments suggested either that

fatal flaws automatically cancel a test,

without MRO involvement, or that the

employer have the authority to cancel a

test when a fatal flaw appears. We

believe that, as the key ‘‘gatekeeper’’

and quality control person in the

system, the MRO is the best party to

make the actual pronouncement of a

cancellation based on a fatal flaw.

Another comment suggested that an

error in the chain of custody

documentation should result in the

cancellation of a test. The problem here

is that not all errors are created equal.

Depending on the seriousness of an

error and our ability to fix it, an error

on the CCF can be a fatal flaw, a

correctable flaw, or a de minimis error

that does not result in cancellation.

Finally, a commenter asked whether

Bottle B may be redesignated as Bottle

A, as the final paragraph of this section

suggests. This has been an interpretation

issue under the existing rule, but we are

clear in this final rule that such

redesignations can take place.

Section 40.201 What Problems Always

Cause a Drug Test To Be Cancelled and

May Result in a Requirement for

Another Collection?

This section is based on § 40.199 of

the NRPM. One commenter suggested

treating invalid test results as refusals.

As we have discussed above, the

Department did not adopt this

suggestion. There were no other

substantive comments on this section,

which we have adopted with some

editorial changes and the addition of a

paragraph pertaining to the failure of an

adulterated or substituted result to

reconfirm.

Section 40.203 What Problems Cause a

Drug Test To Be Cancelled Unless They

are Corrected?

This section is based on § 40.201 of

the NPRM and concerns ‘‘correctable

flaws.’’ Commenters generally approved

the proposed provision, but had varied

suggestions. As in the case of fatal flaws,

one suggestion was to allow employers

to cancel tests in the case of an

uncorrected flaw. As we said in that

case, we believe that MROs are the best

party to take all such actions in the drug

testing program. Two commenters

disagreed concerning the situation of a

missing employee signature coupled

with a lack of collector notation of the

omission: one said it should be a fatal

flaw and the other said it need not be

even a correctable flaw. We believe that

the NPRM formulation of making this

situation a correctable flaw makes the

most sense, giving due regard both to

the need for completeness of the

documentation and the ability to work

around inadvertent administrative

mistakes.

A commenter suggested that an

incorrect employee social security

number (SSN) or other ID number (e.g.,

a transposition of numbers) should not

be a fatal or correctable flaw. We agree

with this comment. We also believe that

a minor transposition error is the kind

of irregularity that would not cause a

test to be cancelled (see § 40.209). If an

ID number is completely wrong (e.g.,

appears to be a different number

altogether) is too badly garbled to be

useful in establishing the employee’s

identity, we view the number as having

been omitted, which is a correctable

flaw under paragraph (c). Another

commenter suggested that the

combination of a wrong ID number and

a missing employee signature should be

a fatal flaw. In our view, both of these

items independently are correctable

flaws, meaning that if either is left

uncorrected the test is cancelled. This is

a sufficient safeguard, we believe.

Section 40.205 How Are Drug Test

Problems Corrected?

This provision is based on proposed

§ 40.203 and concerns how correctable

flaws and other problems are corrected.

There were few comments on this

section. One commenter said there

should be a time limit (e.g., five days)

for making corrections, and that errors

should be taken into account during

verification. We agree that corrections

should be timely, and while we do not

believe that an absolute ‘‘statute of

limitations’’ is appropriate, we have

added language directing parties to

supply this information on the same

business day on which they are notified

of the problem, transmitting it by fax or

courier. Aside from fatal or uncorrected

flaws that cause a test to be cancelled,

there is no role for consideration of

these kinds of mistakes in the

verification process, which focuses on

whether there is a legitimate medical

explanation for a test result.

Another comment suggested that the

use of a non-DOT form could be

corrected by annotating the remarks

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79503

section of the non-DOT form with the

needed information. We do not object to

this form of correction in the situation

where the form was used out of

necessity (e.g., only form available for a

post-accident test), though we do not

think it is necessary to include this

point in the rule text. It would

obviously be contradictory to use this

approach where the non-DOT form was

allegedly used ‘‘inadvertently,’’ since a

collector who noticed the use of the

form sufficiently to make the annotation

would clearly have been aware of what

form he or she was using.

Section 40.207 What Is the Effect of a

Cancelled Drug Test?

This section is based on § 40.205 of

the NPRM. There was only one

comment, which asked for guidance on

what to do if an employee with a

confirmed positive test had his or her

test cancelled because of a fatal or

uncorrected flaw. Other provisions of

this part determine what action the

employer is authorized or required to

take. For example, following a

cancellation of a verified positive test

because a split specimen was

unavailable for testing, there must be an

immediate recollection under direct

observation.

Section 40.209 What is the Effect of

Procedural Problems That Are Not

Sufficient to Cancel a Drug Test?

There were few comments on this

section, which is based on § 40.207 of

the NPRM. The NPRM version stated a

general principle: tests cannot be

cancelled based on an error that does

not have a significant adverse effect on

the right of the employee to have a fair

and accurate test. The point of this

proposal was to prevent administrative

or judicial decisions invalidating drug

tests that were fair and correct, but had

certain de minimis irregularities. One

commenter objected to this principle,

saying that tests should be cancelled in

these situations. Other commenters

were supportive.

Because of comments to other

sections of the rule asking for

clarification about whether certain

mistakes in the process should be the

basis for cancellation, and on the basis

of the Department’s experience in

dealing with issues in many drug testing

cases, we have decided to add to this

section a list of matters that, consistent

with this principle, never result in the

cancellation of a test. This is not an

exclusive or exhaustive list. These

matters must be documented, and may

result in corrective action for employers

or service agents involved, but the

proper remedy is not to cancel the test.

This is a safety rule, and it is not

consistent with safety to permit

someone with a positive drug test to

continue performing safety-sensitive

functions because a collector made a

minor paperwork error that does not

compromise the fairness or accuracy of

the test.

One of the points we make in this

section is that a urine collection or an

alcohol test must not be cancelled solely

because the collector, BAT, or STT has

not met training requirements. Such a

test would be cancelled only if there

were a fatal flaw or other circumstances

requiring cancellation. However, an

organization that had a pattern or

practice of using untrained collectors,

BATs, or STTs would be subject to DOT

enforcement action (in the case of an

employer) or a PIE (in the case of a C/

TPA or other service agent).

Subpart J—Alcohol Testing Personnel

Generally speaking, there were far

fewer comments on the alcohol testing

portions of the rule than on the drug

testing and other sections. Throughout

much of the alcohol testing portion of

the rule, one commenter provided

extensive rewrites of the proposed

regulatory text. These comments were

clearly the product of substantial and

thoughtful work on the commenter’s

part. For the most part, however, the

suggested rewrites did not propose

significant substantive changes in the

proposed text. We will not discuss these

rewrites on a paragraph-by-paragraph

basis, except where they raise a

substantive point that calls for a

response.

Section 40.211 Who Conducts DOT

Alcohol Tests?

The only comments on this section

had to do with the limitation on

supervisors serving as BATs or STTs for

their own subordinates. Some

commenters said that this restriction

should be modified, since many

supervisors had been trained as BATs

and there were some situations, such as

ships at sea, where supervisors might be

the only BATs or STTs available. We

note that the proposed regulation

already permitted supervisors to serve

as BATs and STTs if no one else were

available and DOT agency alcohol

testing regulations allowed this practice.

As in the case of collectors in the drug

testing program, we have used the term

‘‘immediate’’ supervisors to indicate

that someone higher up in the chain of

command was not limited by this

restriction.

Section 40.213 What Training

Requirements Must STTs and BATs

Meet?

The Department has revised this

training both in response to comments

and to parallel, as much as feasible, the

training requirements for collectors in

the drug testing program. One comment

we adopted in both places was to permit

use of a variety of training media (e.g.,

classroom instruction, internet, video,

CD–ROM) for the academic portion of

the training. For the proficiency

demonstration part of the training,

however, absent technological means of

real-time monitoring and evaluation of

actual proficiency demonstrations, inperson monitoring would be necessary.

We also replaced the proposed

‘‘sufficiently knowledgeable’’ language

referring to trainers, which commenters

said was too vague, with a series of

criteria relating to experience or course

work in the testing field.

One commenter suggested a list of

scenarios that should be randomly

included in the three consecutive errorfree collections needed to demonstrate

proficiency for BATs. Without

specifically endorsing the commenter’s

list, we believe that this is a useful

suggestion. The Department’s guidance

on training will include a list of this

type for use of persons conducting

training.

As in the case of collectors in the drug

testing program, BATs and STTs would

have to undergo refresher every five

years, and error correction training

when needed. Most commenters on the

subject favored these kinds of training,

though some had reservations about

what they viewed as the higher costs of

the training. In this matter, we believe

that insistence on high training

standards is no vice, and moderation in

the pursuit of a well-trained work force

is no virtue. Such a work force is vital

to the integrity of the program.

As in the drug testing collector

training, some commenters favored

waiting until more than one error

resulting in cancellation of a test had

occurred before requiring error

correction training. As in that case, we

believe that any such event creates an

important training opportunity, to make

sure that the individual does not make

the same mistake in the future.

Section 40.215 What Information

About the DER do Employers Have To

Provide to BATs and STTs?

Proposed § 40.215 proposed various

record retention and information

requirements for organizations

employing BATs and STTs. Because we

believe it would relieve paperwork

79504 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

burdens for employers and C/TPAs to

have BATs and STTs maintain

documentation of their training and

qualifications (as § 40.213 provides), the

only remaining portion of this section is

proposed paragraph (c). This paragraph,

on which there were no substantive

comments, tells employers to provide to

BATs and STTs the name and phone

number of a DER.

Section 40.217 Where is Other

Information on the Role of STTs and

BATs Found in This Regulation?

This is another in the series of crossreference sections, pointing readers to

other sections of the rule relevant to the

functions of BATs and STTs.

Subpart K—Testing Sites, Forms,

Equipment and Supplies Used in

Alcohol Testing

Section 40.221 Where Does an Alcohol

Test Take Place?

We adopted this provision without

substantive change.

Section 40.223 What Steps Must be

Taken To Protect the Security of

Alcohol Testing Sites?

We adopted a comment to include

ASDs in the requirement to secure

testing devices when they are not being

used. In response to another comment,

we created an exception to the rule that

BATs and STTs may not leave the

testing site when a test is in progress.

The exception is for a situation in which

the BAT or STT must notify a

supervisor or contact a DER for

assistance in the case an employee or

other person who obstructs, interferes

with, or unnecessarily delays the testing

process. Otherwise we have adopted the

proposed section without substantive

change.

Section 40.225 What Form Is Used for

an Alcohol Test?

Most of the comments on this section

focused on changes commenters sought

in the ATF. The form has been revised,

and we have included it at Appendix F.

Its use will become mandatory on

August 1, 2001. We have also modified

the language concerning foreignlanguage versions of the form to be

consistent with the parallel provision

concerning the CCF.

Section 40.227 May Employers Use the

ATF for non-DOT Tests, or non-DOT

Forms for DOT Tests?

This section parallels the

requirements for use of the CCF in the

drug testing program. The few

comments on the section were

supportive of the Department’s

approach.

Section 40.229 What Devices Are Used

To Conduct Alcohol Screening Tests?

We adopted one comment, including

a clarifying note in § 40.231 that only

EBTs listed in the NHTSA CPL without

an asterisk can be used in the DOT

alcohol testing program.

Section 40.231 What Devices Are Used

To Conduct Alcohol Confirmation

Tests?

We adopted one of several editorial

comments we received on this section

from a commenter, which is to remove

the word ‘‘sequential’’ from the

requirement that an EBT print a unique

number on each copy of the result. As

the commenter noted, the important

thing is for the same unique test number

to be displayed before the test and

printed out on the result.

Section 40.233 What Are the

Requirements for Proper Use and Care

of EBTs?

A number of commenters said it was

unclear in the proposed version of this

section who was responsible for what.

To address this problem, we place

responsibility on the user of the EBT,

who could be an employer or a service

agent. We asked in the preamble to the

NPRM whether we should retain the

requirement for quality assurance plans

(QAPs). Most commenters favored

retaining this requirement, and we have

done so. We are not specifying in the

rule, however, who is authorized to

perform various maintenance,

calibration, etc., functions, as one

commenter suggested. We are not in a

good position to determine who can best

perform these functions.

Section 40.235 What Are the

Requirements for Proper Use and Care

of ASDs?

Most of the comments on this section

were editorial. One commenter

expressed concern that the section

appeared to focus on saliva ASDs to the

exclusion of breath ASDs. This is not

the case. These sections are derived

from provisions of the existing

regulation that apply to breath devices

as well as saliva devices. Because the

‘‘use and care’’ requirements for EBTs of

§ 40.233 also apply to breath ASDs, we

have added a cross reference to § 40.233

for clarity.

Subpart L—Alcohol Screening Tests

Section 40.241 What Are the First

Steps in Any Alcohol Screening Test?

Many comments on this section were

parallel to the comments on § 40.61. In

response to the concern about tests not

being scheduled in advance, we

changed the language to refer to

situations in which tests were

scheduled. We also added language

telling BATs and STTs to begin testing

without ‘‘undue’’ delay. We did not

adopt comments suggesting that it was

appropriate for the testing process to

wait upon the arrival of employer or

employee representatives.

One commenter noted an

inconsistency between the way the

NPRM treated refusals to sign the

certification on the drug and alcohol

testing forms, respectively. In the drug

testing case, the collector is directed to

note the problem in the remarks section

of the form and continue with the test.

In the alcohol testing case, the BAT or

STT is directed to treat the problem as

a refusal to test. We agree that these

provisions should be consistent, and we

have changed the alcohol procedure to

be like the drug procedure.

Section 40.243 What Is the Procedure

for an Alcohol Screening Test Using an

EBT or Non-Evidential Breath ASD?

Commenters had a variety of concerns

about this section. One commenter

asked if showing the employee the

sequential number displayed on the

device has been omitted from this

provision. It has, and the omission was

intended. We do not believe that this

action is necessary to maintain the

integrity of the process. In addition,

these number displays are not available

on all devices, such as some types of

ASDs.

Another commenter had several

suggestions for elaborating on

instructions to the BAT or STT as part

of the preliminary portion of the testing

process. We will consider including

these suggestions in guidance. Another

commenter asked us to specify the

number of times an employee could

blow into a breath device. We do not

think that this is necessary. The point is

to complete the test successfully. If it

becomes apparent that the employee

cannot provide sufficient breath to

activate the device, then we expect the

BAT or STT to use good judgment in

determining when to begin the ‘‘shy

lung’’ procedure.

A commenter suggested allowing the

result printout to be attached either to

the front or the back of the ATF. We will

adopt this comment in our pending

revision of the ATF. Another suggestion

was to use tamper-evident tapes that do

not discolor over time. We think that

this is a good idea, but not one that we

need to mandate in rule text. We have

adopted a commenter’s suggestion that

a self-adhesive label that is tamperevident can be used to affix a result

printout to the ATF.

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79505

Section 40.245 What Is the Procedure

for an Alcohol Screening Test Using a

Saliva ASD?

The Department is adopting the

proposed section without substantive

change. One commenter asked to

include material pertaining to new

evidentiary saliva devices. At the time

of the publication of this rule, NHTSA

is looking at such devices, but NHTSA’s

review is not complete. NHTSA is

considering modifying its model

specifications for evidential breath

testers to accommodate technologies

that measure alcohol in other bodily

fluids, such as saliva. If adopted, such

changes would also require technical

adjustments to Part 40 so that both the

NHTSA action and Part 40 requirements

worked smoothly in concert.

Subsequent to this revision of Part 40,

any proposed modifications to NHTSA

model specifications or Part 40 to

accommodate the above advances in

technology would be published in the

Federal Register, so that the public may

comment on them before any changes

are made final.

Another commenter said that the ATF

can get too sloppy when the STT

attempts to use the same form for two

separate devices. There is no mandate to

use the same form. If one form is getting

too cluttered, the STT can use a new

form for the part of the process

involving the second device. This

commenter also said that, in the event

the device does not activate on the first

try, the STT should not have to place

the device in the employee’s mouth for

the second attempt. We believe that

maintaining this requirement is useful

to ensure that the second attempt is

more likely to succeed (e.g., in a

situation in which the employee has

used the device incorrectly at first). This

commenter also suggested that there

may be situations in which it is not

possible to conduct a new test on an

EBT, when the STT could not

successfully follow ASD procedures. We

agree with the commenter that the

regulation should include language to

address this situation, and we have

added a provision to § 40.271(a)(3) for

this purpose.

Section 40.247 What Procedures Does

the BAT or STT Follow After a

Screening Test Result?

This section is also substantively

unchanged from the NPRM. One

commenter preferred splitting the

section into several sections, believing

that this would make the requirements

more clear. Paragraphs (a), (b), and (c)

each are devoted to a single situation

(test result of less than 0.02, result of

0.02 or greater, invalid result). We

believe this organization is sufficiently

clear. This commenter also suggested

that we clarify that the employee must

be observed during the waiting period

in all circumstances. We agree, and we

have added language to this effect to

§ 40.251(a)(1). The purpose of this

observation is to ensure that the

employee remains under the control of

responsible personnel during the

waiting period and does not take any

actions that could interfere with the

successful completion of the testing

process.

Several comments asked that BATs be

able to transmit test results to employers

via C/TPAs, acting as intermediaries.

Consistent with the Department’s

decisions in the drug testing part of the

rule, the final rule will permit

transmission of negative results by this

means. (We will not permit positive

results to be sent in this way. For

safety’s sake it is essential that these

results be transmitted immediately and

directly since, unlike drug test results,

positive alcohol test results involve

impairment.) Another commenter

suggested that the ATF include a

provision for a statement or check box

to indicate that the employee had

received instruction about the waiting

period between the screening and

confirmation tests. We will consider

doing so as part of our pending revision

of the ATF.

Subpart M—Alcohol Confirmation

Tests

Section 40.251 What Are the First

Steps in Any Alcohol Confirmation

Test?

One commenter suggested editorial

changes to clarify the timing of the

waiting period and the confirmation

test, in paragraph (a)(1). We have

adopted this language. We have not

adopted other editorial suggestions for

this section, because we believe they are

not necessary to clarify the proposed

language. We disagree with a comment

suggesting that conducting a

confirmation test more than 30 minutes

after the screening test should not be

permitted. While, as paragraph (a)(1)

states, it is desirable that the

confirmation test begin within 30

minutes, we realize that circumstances

(e.g., transportation from the screening

test site to a different confirmation test

site) could delay the test past this point.

Better a delayed test than none at all.

Section 40.253 What Are the

Procedures for Conducting an Alcohol

Confirmation Test?

At a commenter’s suggesting, we

added the word ‘‘conducting’’ to the

first line of this section. Consistent with

§ 40.243, we have added language

saying that a self-adhesive label that is

tamper-evident can be used to affix a

result printout to the ATF. The section

is otherwise unchanged from the NPRM

version. We do not believe extensive

editorial changes are needed. One

commenter said that all test results of

0.02 or greater made on a defective

machine before corrective action is

taken must be cancelled. This point is

covered by § 40.267(c)(5). We will leave

the word ‘‘sequential’’ in paragraph (f).

This section involves the use of EBTs,

all of which have sequential test number

displays.

Section 40.255 What Happens Next

After the Alcohol Confirmation Test

Result?

Aside from a few editorial changes

and additional requests that C/TPAs be

able to act as intermediaries in the

transmission of results, there were no

comments on this sections. We have

addressed the C/TPA transmission issue

elsewhere. We have adopted the

proposed section without change.

Subpart N—Problems in Alcohol

Testing

Section 40.261 What Is a Refusal To

Take an Alcohol Test, and What Are Its

Consequences?

In response to a comment, we added

language clarifying that the failure to

remain at a testing site until the testing

process was complete constitutes a

refusal to test. We have deleted the

provision treating refusal of the

employee to sign the ATF certification

in Step 4 as a refusal to test. Otherwise,

the section is substantively unchanged

from the NPRM. We have not made

extensive editorial changes.

Section 40.263 What Happens When

an Employee Does Not Provide a

Sufficient Amount of Saliva for an

Alcohol Screening Test?

There was no substantive comment on

this section, and we have adopted it

unchanged from the NPRM.

Section 40.265 What Happens When

an Employee Does Not Provide a

Sufficient Amount of Breath for an

Alcohol Test?

We have revised this provision to be

parallel, in many respects, with the ‘‘shy

bladder’’ procedure in the drug testing

portion of the rule. These changes

79506 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

include providing that the evaluating

physician must have expertise in the

issues raised by the employee’s failure

to provide a sufficient amount of breath

and that the employee must obtain the

evaluation within five days. (The

physician could be a specialist, but need

not be. What is important is that the

physician have sufficient expertise to

deal effectively with the issues

presented in the employee’s case.) Three

commenters suggested that this time

period should be changed to one, three,

or seven days rather than five days. We

believe that the five-day period should

be generally sufficient and is consistent

with other medical evaluation

provisions of the rule.

However, the Department is aware

that, in some cases, it may be difficult

for an employee to secure, on his or her

own, an appointment for this evaluation

in a short period of time. Consequently,

the Department does not regard it as a

refusal to test if the employee is unable,

after making good faith efforts, to get the

appointment within the 5-day period.

However, the employer should do

everything feasible to assist the

employee in finding and getting an

appointment with an appropriate

physician.

A commenter suggested giving

employees additional attempts to

provide a sufficient amount of breath to

complete a test. We have modified this

section to permit an additional attempt,

if the BAT or STT believes that it would

be useful (e.g., because the employee

came close on the second attempt or

made a mistake in using the device that

could be readily corrected). It is not

mandatory for the BAT or STT to

provide this third attempt. At this

commenter’s suggestion, we have also

added language telling the BAT or STT

to instruct the employee on the proper

use of the device.

Section 40.267 What Problems Always

Cause an Alcohol Test To Be Cancelled?

One commenter disliked the use of

the word ‘‘cancelled,’’ preferring

‘‘invalid.’’ The term ‘‘invalid’’ has a

specific meaning in the drug testing part

of the rule, so we think it better to avoid

the word here. ‘‘Cancelled’’ has the

same meaning here as it does in drug

testing, and should not cause any

confusion. A commenter suggested

adding rule text requiring BATs and

STTs to notify DERs within 48 hours of

the discovery of a fatal flaw. We agree

that prompt notification is important,

and we have added language to § 40.273

to this effect. We put this provision into

§ 40.273 so that it applies to all

cancellations.

Section 40.269 What Problems Cause

an Alcohol Test To Be Cancelled Unless

They Are Corrected?

There were no substantive comments

on this section, which is unchanged

from the NPRM.

Section 40.271 How Are Alcohol

Testing Problems Corrected?

As discussed above, we have added a

new paragraph (a)(3) to this section,

concerning situations in which a new

testing device is not available at the

testing site. We have also added a new

paragraph (c), clarifying that when a

correctable flaw cannot be corrected, the

test must be cancelled. We did not

receive substantive comments on this

section, which is otherwise unchanged

from the NPRM.

Section 40.273 What Is the Effect of a

Cancelled Alcohol Test?

There were no substantive comments

on this section, the proposed text of

which is unchanged from the NPRM.

We have added new paragraphs ( c) and

(d), which respectively call for

notification of the DER and state that a

cancelled test is not intended to provide

a basis for a subsequent test under

company policy,

Section 40.275 What Is the Effect of

Procedural Problems That Are Not

Sufficient To Cancel an Alcohol Test?

Section 40.277 Are Alcohol Tests

Other Than Saliva or Breath for

Screening and Breath for Confirmation

Permitted Under These Regulations?

There were no substantive comments

on these sections, which are unchanged

from the NPRM.

Subpart O—Substance Abuse

Professionals and the Return-to-Duty

Process

Section 40.281 Who Is Qualified To

Act as a SAP?

Section 40.283 How Does a

Certification Organization Obtain

Recognition for Its Members as SAPs?

These sections were both based on

proposed § 40.281. We received

extensive comment on the question of

who should be viewed as eligible to

perform SAP functions. Many

individuals, professional organizations,

and certification organizations (e.g., for

drug and alcohol counselors, marriage

and family therapists, licensed

professional counselors) asserted that

their qualifications were as appropriate,

if not more so, than groups and

professions which the rule views as

eligible. Without denigrating the

qualifications of any individuals,

professions, and organizations, the

Department believes that the proposed

rule continues to identify those

professions and organizations that

currently are best equipped to perform

the SAP function in the DOT drug and

alcohol testing program.

This is a program that is national in

scope, and we believe that, for persons

who wish to act as SAPs based on

membership in a licensed or certified

profession, it is reasonable to require

that the licensure or certification be

available in all U.S. states. For persons

who wish to act as SAPs based on an

organizational certification, the

Department has set forth criteria in

Appendix E for the requirements that

must lie behind such certifications. The

Department developed these criteria

under the existing rule as a means of

evaluating applications to the

Department for SAP eligibility, and they

are consistent with the requirements of

certification organizations that are

already part of the SAP program.

The NPRM proposed to require

organizations that certify counselors to

obtain National Commission for

Certifying Agencies (NCCA)

accreditation before submitting their

requests to have the Department

consider their certified counselors for

inclusion in the SAP definition. The

NPRM also proposed that the two

certifying organizations whose

counselors are already in the SAP

definition (i.e., the National Association

of Alcoholism and Drug Abuse

Counselors Certification Commission

(NAADAC) and the International

Certification Reciprocity Consortium/

Alcohol and Other Drug Abuse (ICRC))

would not be required to have NCCA

accreditation because they have already

been through a rigorous Department

process prior to their inclusion.

Commenters overwhelmingly

supported the concept of having

certification organizations obtain NCCA

accreditation prior to submitting their

requests to have their certified

counselors considered for inclusion to

the Department. A few organizations

opposed any type of review by any

organization, including the Department,

prior to having their certified counselors

added to the SAP definition. A few

commenters wanted the Department to

maintain total control of the review

process—a process that proved entirely

too burdensome and time consuming for

us. Still other commenters wanted us to

clarify that the NCCA accreditation

requirement (and Appendix F of Part

40) applied solely to certifying

organizations wishing to have their

counselors included in the SAP

definition and not to physicians, social

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79507

workers, psychologists, and employee

assistance professionals; and not to

NAADAC and ICRC. Those who

commented on NAADAC and ICRC, did

not believe NCCA accreditation was

necessary for those two groups.

Part 40 will require certification

organizations wishing to have their

certified counselors included in the SAP

definition to meet the requirements

(which includes NCCA accreditation) at

Appendix F of Part 40 prior to asking

the Department to review their

inclusion proposals. The Department

will still receive and review all

proposals for inclusion based upon

Appendix F standards. It is important to

note that NCCA accreditation is simply

one of the prerequisites for inclusion,

but it represents an area of review that

the Department found to be the largest

barrier to our streamlining the process

for reviewing certification groups’

application materials and for evaluating

the quality of those groups’ certification

testing processes.

Because NAADAC and ICRC excelled

in the Department’s previous review

process, they will be compelled neither

to have NCCA accreditation nor to

complete the process again. Physicians,

social workers, psychologists, and

employee assistance professionals were

never intended to have NCCA

accreditation. This requirement is not

for them: it is only for certification

organizations wishing to have their

certified counselors added to those of

NAADAC and ICRC.

A few commenters suggested that all

SAPs be certified by the Department.

One suggested that we support any

future proposals by the Substance

Abuse and Mental Health Services

Administration to certify drug and

alcohol counselors. While we support

efforts to ensure that SAPs are better

trained (and Part 40 has new training

requirements for SAPs), the Department

lacks the expertise, personnel, and time

needed to establish and operate a SAP

counselor certification effort. Like the

lone commenter mentioned in this

paragraph, we would support efforts by

HHS to develop certification standards

and subsequently certify all drug and

alcohol counselors.

As was the case with commenters on

MRO training, most commenters on SAP

training thought that self-certification

was not adequate. Many comments

favored more formal training

requirements for SAPs, like those

proposed for MROs. Some of these

comments mentioned situations in

which they believed SAPs had made

poor decisions based on an incomplete

understanding of their role under the

DOT rules.

The Department is persuaded that

more formal SAP training is

appropriate. Like MROs, SAPs are

highly-qualified professionals. They

play a key role in the return-to-duty

process, which has important safety

implications. In addition to their

professional qualifications, they need to

be very aware of their role in

implementing DOT agency drug and

alcohol testing rules. Consequently, the

Department is revising SAP training

requirements to parallel the training

requirements for MROs. The

Department is aware that there are not

currently an array of SAP courses

analogous to the MRO courses that

medical groups currently present. For

this reason, the SAP qualification

training deadline has been extended to

December 2003. However, the

Department anticipates that, in the time

permitted for new and current SAPs to

meet this requirement (see

§ 40.281(c)(3)), the demand for training

will lead to a supply becoming

available. We believe that organizations

will take the opportunity to create

appropriate training courses and

materials.

Like qualification training for MROs,

SAP qualification training includes a

requirement for an examination.

However, the Department does not

believe that this examination need be a

formally designed and validated

examination. SAP functions are

narrower in scope and less complex

than MRO functions, and the

examination can therefore be simpler, in

our view. The purpose of SAP training

and the examination is not to teach

people how to be clinicians, but rather

to help SAPs learn how to operate in

their specialized role within the DOT

regulatory framework.

As with MROs, we have added a

continuing education requirement to

keep SAPs current on program

requirements and issues. This

continuing education must involve a

test or other assessment tool to help

SAPs determine whether they have

successfully learned the material.

Section 40.285 When Is a SAP

Evaluation Required?

This section is based on § 40.283 of

the NPRM. Consistent with other

provisions of the rule, we have added

adulteration and substitution results to

the situations requiring SAP

evaluations. We disagree with a

commenter who said that an alcohol test

result of 0.04 or greater was not a

violation of DOT agency alcohol

regulations. It is a violation, and a SAP

evaluation is a necessary part of the

return-to-duty process following such a

violation. Some comments questioned

whether a SAP evaluation was

necessary in all cases (e.g., including

pre-employment tests) following a

violation. It is, and we have added some

clarifying language to this effect. In the

case of a pre-employment test violation,

the employer to whom the individual

had applied would be responsible for

providing the individual information

about SAP resources and the return-toduty process, even if the employer

wanted no further relationship with the

individual.

A commenter asked whether a SAP

evaluation would be needed for an

employee who had a DUI/DWI charge

against him or her in a private

automobile. The answer is no: under

Part 40 only a violation of DOT agency

drug and alcohol testing rules triggers

the requirement for a SAP evaluation

(though DOT agency rules may impose

additional requirements in some cases).

Another commenter recommended that

applicants who test positive on preemployment tests should be required to

present evidence of having completed

the return-to-duty process before being

able to work in a safety-sensitive

position for another employer. We have

addressed this issue in § 40.25,

concerning inquiries about previous test

results.

Section 40.287 What Information Is an

Employer Required To Provide

Concerning SAP Services to an

Employee Who Has a DOT Drug and

Alcohol Regulation Violation?

This section is based on proposed

§ 40.285 of the NPRM. There were few

comments. One asked whether the

employer or the employee was to select

the SAP. This section does not address

selection of a SAP: it just says that the

employer has to provide the employee

a list of SAPs and how to reach them.

The provision does clarify that this

requirement applies to all violation

situations, including pre-employment

tests. If an applicant fails a preemployment test, the employer must

provide this information even if the

employer intends not to hire the

applicant.

Section 40.289 Are Employers

Required To Provide SAP and

Treatment Services to Employees?

This provision is based on proposed

§ 40.287 of the NPRM. Paragraphs (a)

and (c) emphasize the employer’s

provision of SAP services. An employer

may or may not provide SAP-related

services to employees. An employer

may or may not pay for such services.

These are matters the Department leaves

to employer discretion or laborVerDate 11<MAY>2000 18:26 Dec 18, 2000 Jkt 190000 PO 00000 Frm 00047 Fmt 4701 Sfmt 4700 E:\FR\FM\19DER2.SGM pfrm02 PsN: 19DER2
79508 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

management negotiations. One

commenter suggested that employers be

required to cover these services in their

health plans. We believe that, as the

commenter acknowledged, imposing

coverage requirements on health care

providers or insurers is outside the

Department’s jurisdiction.

The proposed § 40.287 included two

paragraphs telling employers that they

must ensure the SAPs used to evaluate

employees before they return to duty

meet certain qualifications. In view of

the SAP training and qualification

provisions of § 40.281 of the final rule,

we believe these paragraphs are

duplicative, and we have deleted them.

This section continues to emphasize

that, before an employee who has

violated a DOT agency drug and alcohol

testing regulation may return to safetysensitive duties, the employee must

successfully complete the SAP

evaluation/return-to-duty process.

Section 40.291 What Is the Role of the

SAP in the Evaluation, Referral, and

Treatment Process of an Employee Who

Has Violated DOT Agency Drug and

Alcohol Testing Regulations?

The content of proposed § 40.291 has

been moved to § 40.355(a). This section

now concerns a different subject, stating

the general duties of SAPs.

Section 40.293 What is the SAP’s

Function in Conducting the Initial

Evaluation of an Employee?

The final rule has no equivalent to

proposed § 40.289, the content of which

duplicates other provisions in this

subpart. There were few comments

concerning § 40.293, and they were

mostly supportive. Some comments did

favor allowing C/TPAs to transmit SAP

reports to employers. As discussed in

the ‘‘Principal Policy Issues’’ section of

the preamble, we have chosen not to

permit this, as a means of preventing

anyone from having the opportunity to

alter the SAP’s report and

recommendations.

We have added three new points to

this section. First, as discussed in the

‘‘Principal Policy Issues’’ section of the

preamble, we believe that there are no

circumstances in which it is appropriate

for a SAP to find that a violator of our

regulations is not in need of education

and/or treatment. Therefore, paragraph

(b) requires that SAPs make a

recommendation for education and/or

treatment in every case. Second, we

have become concerned that we have

not previously given SAPs guidance

with respect to employees’ stories that

minimize the seriousness of their

violations, analogous to the guidance we

give MROs with respect to legitimate

medical explanations. Therefore,

paragraph (f) specifically forbids SAPs

from taking certain kinds of factors into

account in making their

recommendations.

Third, while we are not making

quantitations routinely available to

SAPs in drug testing cases (see

discussion in ‘‘Principal Policy Issues’’),

we believe it is very important for MROs

and SAPs to have good communications

about employees. Paragraph (g)

explicitly authorizes SAPs to consult

with MROs, and tells MROs they must

cooperate with SAPs in these

consultations.

Section 40.295 Can Employees or

Employers Seek a Second SAP

Evaluation if They Disagree With the

First SAP’s Recommendations?

The purpose of this section is to

prevent employers and employees from

forum shopping until they get a SAP

evaluation they like. Most comments

supported the proposed prohibition on

second opinions, though one

commenter thought this should be

permitted if the original SAP does a bad

job. The difficulty with this suggestion

is that a party’s perception of the quality

of the SAP’s work is likely to be

influenced on whether the SAP made a

recommendation the party feels is in its

interest. We believe that a prohibition

on second opinions is the only way to

prevent forum shopping.

One commenter suggested that we

remove the reference to the SAP being

suitable to the employer. We believe the

proposed language in this section is

unnecessary, and we have deleted it.

Also, to tighten the provision, we have

added a sentence saying that if,

notwithstanding the regulatory

prohibition, an employee gets an

evaluation from a second SAP, the

employer must not pay any attention to

it.

Section 40.297 Does Anyone Have the

Authority To Change a SAP’s Initial

Evaluation?

Several commenters noted that the

language of the proposed section

appeared to prevent even the SAP who

originally made the recommendation

from modifying his or her own

recommendation. We did not intend to

prevent SAPs from modifying their own

recommendations, and we have added

clarifying language that permits SAPs to

do so when they receive new or

additional information.

Section 40.299 What Is the SAP’s Role

and What Are the Limits on a SAP’s

Discretion in Referring Employees for

Treatment and Education?

A number of commenters appeared to

prefer stating one of the exceptions to

the rule against self-referral in terms of

SAPs located in ‘‘rural and remote

areas’’ rather than the NPRM’s ‘‘general

commuting area’’ language. The

Department does not believe that this

would improve the clarity of the

section, since ‘‘rural’’ and ‘‘remote’’ are

rather subjective terms. The exception is

intended to apply, in any case, to a

situation in which there is no other

source of services reasonably available

in the vicinity. For example, if an

employee had to make an overnight trip

to get to another source of services, we

would not consider it reasonably

available.

One commenter wanted to consider

referrals to spouses as prohibited by this

section. We believe this is covered by

the prohibition on referrals to people

with whom the SAP shares a financial

interest. Another commenter wanted to

create a fifth exception for in-house

corporate SAPs. We believe that the

second and third exceptions are

adequate to cover this situation. We also

received a suggestion to delete the

signed statement requirement of

proposed paragraph (d). Given the

specificity of the other requirements of

the section, we do not believe that this

signed statement adds much of

substance, and we have deleted it in the

interest of reducing paperwork.

Section 40.301 What Is the SAP’s

Function in the Follow-Up Evaluation of

an Employee?

Comments were generally supportive

of this section. A few comments pointed

out that some current DOT agency

regulations do not make use of the SAP

process. This is true. However, DOT

agencies will amend their regulations to

conform to Part 40 before the effective

date of this part. Another commenter

asked for clarification of who makes a

return-to-duty determination. SAPs

simply determine whether an employee

has successfully demonstrated

compliance with the SAP’s

recommendations. As this section and

§ 40.305 make clear, only the employer

decides whether, after all prerequisites

have been met, the employee returns to

safety-sensitive duties. In response to

comments that employers should be

notified if the SAP process is taking

longer than expected (e.g., because the

employee has not made expected

progress in treatment), we have added a

provision requiring the SAP to provide

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79509

written notice to the employer when the

employee has not demonstrated

successful compliance on follow-up

evaluation.

The Department understands that not

every employee will make strides in

dealing with a drug or alcohol problem

sufficient to receiving a SAP follow-up

report indicating that he or she has

demonstrated successful compliance

with the SAP’s recommendation. When

this happens, we believe that it is

important that the employer receive a

SAP follow-up report outlining the

reason(s) why the employee has not

demonstrated successful compliance.

We understand that some employees

may be actively involved in carrying out

their education and/or treatment plan

and simply need additional time to

complete the work. Others may have

been non-participants in a SAPrecommended program. Therefore,

when the SAP determines that the

employee has failed to demonstrate

successful compliance, we have no

objection to having the employer

deciding to allow an additional SAP

follow-up evaluation to be made

consistent with the employee’s progress

(or lack of progress) and with employer

policy and/or labor-management

agreements. Nor will the Department

object if the employer chooses instead to

take other personnel actions consistent

with employer policy and/or labormanagement agreements.

Section 40.303 What Happens if the

SAP Believes the Employee Needs

Additional Treatment, Aftercare, or

Support Group Services Even After the

Employee Returns to Safety-Sensitive

Duties?

As discussed in the ‘‘Principal Policy

Issues’’ section of the preamble, we have

deleted a proposed requirement that

employers ‘‘monitor’’ returned

employees’’ aftercare. This was the

subject of the bulk of the comments on

this section. The section now gives

discretion to employers concerning their

monitoring and enforcement of SAP

aftercare recommendations. We strongly

recommend that employers play an

active role in ensuring that employees

who have returned to work following a

violation comply with aftercare

recommendations. This is very

important both for safety and the

welfare of the employees. The rule also

states that employees are obligated to

comply with these SAP

recommendations and are subject to

employer discipline if they do not.

Section 40.305 How Does the Returnto-Duty Process Conclude?

This section underlines the point that

it is the employer, and the employer

alone, who is responsible for deciding

whether an employee who has violated

DOT agency drug and alcohol testing

rules will return to work. A

determination by the SAP that the

employee has successfully complied

with the SAP’s recommendations is a

prerequisite to the employee’s return to

duty. So is a negative result on a

subsequent return-to-duty test. But only

the employer can decide whether or not

to put the person back to work. SAPs do

not make ‘‘fitness for duty’’ decisions,

and employers should not ask them to

do so. Commenters asked that we make

these points clear. We think this section

is as clear on this point as we can make

it.

Section 40.307 What Is the SAP’s

Function in Prescribing the Employee’s

Follow-up Tests?

Section 40.309 What Are the

Employer’s Responsibilities With

Respect to the SAP’s Directions for

Follow-up Tests?

As discussed in the ‘‘Principal Policy

Issues’’ section of the preamble, the

Department has decided to retain the ‘‘at

least six follow-up tests in the first 12

months’’ formulation for follow-up

testing. In response to requests from

commenters, we have clarified that this

follow-up testing requirement ‘‘follows

the employee’’ through job changes and

breaks in safety-sensitive service. The

six tests must occur during the first 12

months of safety-sensitive service after

return-to-duty, regardless of for whom

or when that service is performed.

Of course, SAPs have the discretion to

require more follow-up tests than the

minimum. One commenter suggested

that SAPs negotiate the number of

follow-up tests over the minimum with

the employer. We did not adopt this

suggestion, because this is intended to

be a clinical determination, not subject

to economic or policy give-and-take.

Employers are obligated to follow the

SAP’s follow-up testing plan. All parties

involved should be aware that, under

this rule, all employees who return to

work after a violation will have a

follow-up testing requirement with

which employers and employees must

comply.

Section 40.311 What Are

Requirements Concerning SAP Reports?

Most of the comment on this section

concerned the issue of C/TPAs acting as

intermediaries in the transmission of

SAP reports to employers. As discussed

above, the Department is not permitting

C/TPAs to act in this capacity. SAPs

must send their reports directly to the

DER. The report must be on the SAP’s

own letterhead, not that of a C/TPA or

another service agent.

In response to a comment on the

content of the SAP report, we have used

the term ‘‘date(s)’’ rather than ‘‘date’’ to

cover the possibility that assessments

will happen over a period of time longer

than a single meeting. We have also

clarified that ‘‘reason for the

assessment’’ refers to the date and

nature of the violation of DOT rules, as

a commenter requested, and as DOT’s

SAP Guidelines outline.

Section 40.313 Where Is Other

Information on SAP Functions Found in

This Regulation?

This is the last of the regulation’s

sections providing informational crossreferences to other provisions

concerning, in this case, SAP functions.

Subpart P—Confidentiality and Release

of Information

Section 40.321 What Is the General

Confidentiality Rule for Drug and

Alcohol Test Information?

Several commenters disagreed with

the proposal to continue the

Department’s ban on blanket releases.

These commenters believed that

permitting blanket releases would

facilitate the flow of information among

parties who needed to know, for

example, whether an applicant for a job

had previously violated a DOT

regulation. Other commenters favored

retaining this proposal in order to

protect employee privacy. The

Department believes that the principle

of specific written consent for any

release of test result or medical

information to third parties is critical to

protect employees’ legitimate

expectations of privacy and

confidentiality in the testing program.

Permitting blanket releases is directly

contrary to this principle. The

Department will include the proposed

provision in the final rule.

Section 40.323 May Program

Participants Release Drug or Alcohol

Test Information in Connection With

Legal Proceedings?

The existing rule and the NPRM both

provide that in a proceeding brought by,

or on behalf of, an employee, resulting

from a positive test (e.g., a lawsuit or

grievance), the employer may release

employee test result information

without the employee’s consent. One

commenter suggested that we add

references to substituted and

79510 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

adulterated tests and other refusals to

test. We have done so.

Another commenter raised the issue

of a different kind of legal proceeding.

The commenter asked whether

otherwise confidential information

could be released in a personal injury

lawsuit where the employee’s conduct

was an issue (e.g., a truck or bus driver

involved in a collision). We believe that,

if a court orders the production of such

information because it is relevant in

such a proceeding, it is reasonable for

the employer to provide it without

getting the employee’s consent. In this

situation, the requirements of justice in

the litigation outweigh the employee’s

privacy interest. We have added a

paragraph to this effect. We also added

a paragraph telling a service agent who

is holding this information to provide it

to the employer when the employer

requests it for use in a legal proceeding

covered by this section.

Section 40.327 When Must the MRO

Report Medical Information Gathered in

the Verification Process?

This section provides that, under

certain circumstances, MROs must

provide certain otherwise confidential

information to employers and certain

other parties. The purpose of providing

this information is to enhance safety.

Commenters had a variety of concerns

about this section. One comment

suggested that the medical information

be provided in writing in all cases. We

think that a prudent MRO may choose

to do so, but we do not believe that a

regulatory requirement is needed.

Some commenters objected to the

paragraph that allows MROs to consult

with the employee’s own physician to

see if alternate medication might be

available that would be less likely to

adversely affect safety, saying that

MROs should stay out of what looks like

a doctor-patient relationship with

employees. A few commenters

supported this proposal. Under the

proposal, the MRO would take this step

only with the employee’s consent, and

for the purpose of helping the employee

find medication that would be

compatible with safe job performance.

From both the point of view of

employee interests and safety, we

believe that this proposal is sound, and

we have retained it.

One commenter said that Canadian

law would preclude a doctor from

releasing this information to an

employer. We have added a provision

saying that if the law of a foreign

country, such as Canada, prohibits

MROs from providing medical

information to the employer, the MROs

may comply with that prohibition.

Another commenter pointed out that

not only physicians, but also other

medical professionals, may make

determinations about whether an

employee meets physical qualification

standards. We have adopted the

commenter’s suggestion that the MRO

can release information to the ‘‘health

care provider’’ involved in this activity.

Consistent with the SAP provisions of

the rule, we have included SAPs who

are evaluating employees as part of the

return-to-duty process as a party to

whom the MRO can provide

information under this section.

Finally, as some commenters

requested, we have made it mandatory

for MROs to release information under

this section if the information is likely

to result in the employee being

medically unqualified for performance

of safety-sensitive duties under a DOT

regulation or if the information

indicates that continued performance by

the employee of his or her safetysensitive function is likely to pose a

significant safety risk. In this case, the

Department believes that the safety

interest served by the information

release outweighs the confidentiality

interest of the employee.

We point out that the medical

information described in this section

cannot be transmitted to employers or

other parties using a C/TPA or other

service agent as an intermediary. MROs

must transmit this information directly

to the employer.

Section 40.329 What Information Must

Laboratories and Other Service Agents

Release to Employees?

Proposed § 40.329, concerning release

of information by MROs to third-party

employers, has been deleted, for the

reasons given in the ‘‘Principal Policy

Issues’’ section of the preamble. This

section is based on proposed § 40.331 of

the NPRM.

One commenter requested that the

Department require that laboratories

provide all records requested by an

employee, as well as a laboratory person

to testify in a legal proceeding who has

firsthand knowledge of the laboratory,

its records, and operating procedures.

This commenter also requested that the

rule require the laboratory to make

records available within 10 days, rather

than waiting for payment from the

employee. This section does require that

laboratories and other service agents

provide a ‘‘data package’’ (sometimes

referred to as a ‘‘litigation package’’)

upon the employee’s request. We do

require that they provide it within 10

business days. The rule also limits the

charge the service agent can make for

the cost of copying and preparation. We

believe these provisions adequately

protect employee interests. We do not

believe it is necessary, as another

commenter suggested, to list the

contents of a litigation package, which

is quite standard and well understood

among laboratories.

We have not adopted the suggestion

that laboratories be required to produce

witnesses for appearances at legal

proceedings. Such an open-ended

requirement would impose, in our view,

unnecessary costs and burdens on

laboratories and other service agents.

There are adequate means (e.g.,

documentary evidence) through which

employees can raise issues about the

testing process.

The NPRM proposed that laboratories

provide to employees, on written

request, information relating to the

results of relevant HHS certification

reviews. One comment supported this

proposal, which is consistent with longstanding DOT interpretation of the

existing Part 40, while another

commenter proposed that the

laboratory’s obligation be limited to the

latest HHS Federal Register notice

listing the laboratory as certified. Based

on conversations with HHS staff, we

have decided to delete this provision.

HHS staff believe that providing this

information would unnecessarily

intrude on the HHS-laboratory

relationship and could result in the

introduction of misleading information

about the laboratory certification

process in legal proceedings involving

drug test results.

Section 40.331 To What Additional

Parties Must Employers and Service

Agents Release Information?

This section is based on § 40.333 of

the NPRM. Some commenters objected

to being required to permit DOT

representatives to see a broad array of

drug and alcohol testing information.

DOT has significant safety

responsibilities for transportation

industries, of which our drug and

alcohol testing rules are an important

part. As part of its safety mandate, DOT

must be able to inspect regulated

employers and those who carry out their

drug and alcohol testing program

responsibilities. DOT cannot do this job

unless we have access to all relevant

information. We believe it is vital to

maintain this provision in the final rule.

We would point out, particularly in

response to a comment that Canadian

MROs could not legally release certain

information, that this paragraph focuses

on the inspection and review of

documents as part of the DOT oversight

process, not on release of information to

third parties.

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79511

Commenters pointed out that, in some

jurisdictions, state laws or rules require

employers or service agents to provide

drug test result information to state law

enforcement or safety agencies. To

ensure that there is no conflict between

Part 40 and these state laws or rules, we

have added language (already found in

some DOT agency rules) to this section.

It says that if requested by a state or

local safety agency with regulatory

authority over the employer or

employee, employers and service agents

must provide drug and alcohol test

records concerning the employee to the

agency. This paragraph also covers

Federal agency requests (including

requests by DOT, HHS, and the National

Transportation Safety Board) for drug

and alcohol test records. It should be

noted that this paragraph applies only to

testing records. It does not authorize

provision of specimens.

We have also added a paragraph

stating in rule text the advice we have

frequently given to employers and

service agents faced with subpoenas or

other orders directing them, contrary to

Part 40 requirements, to produce

specimens where Part 40 does not

permit. What is a laboratory or other

party to do if it gets a request to produce

a urine specimen or aliquot for an

unauthorized test? The first thing the

laboratory should do is to ‘‘just say no,’’

giving this DOT regulatory mandate as

the reason. If someone seeks a subpoena

or other court order directing the

production of the specimen, the

laboratory’s attorneys should seek to

quash or resist the action, asserting on

the basis of this section that such an

order is contrary to Federal law and

subject to Federal pre-emption (under

the existing pre-emption provisions of

DOT agency drug and alcohol

regulations). In such cases, we suggest

that laboratories call the Department to

consult about the matter. If a court

ultimately issues a binding order

requiring the production of the

specimen, the laboratory may comply

(we do not seek to make laboratories

subject to contempt citations). However,

as noted above, employers must

continue to implement all consequences

of a verified positive test required by

DOT rules, regardless of the outcome of

the unauthorized test or any personnel

process decisions flowing from it.

Section 40.333 What Records Must

Employers Keep?

This section is based on § 40.335 of

the NPRM. In response to a number of

comments and consistent with decisions

reflected elsewhere in this document,

proposed requirements for the retention

of records concerning training of service

agents and signed agreements with

service agents have been deleted. Under

the final rule, collectors, BATs, MROs

etc. will maintain their own training

records, and employers will not have

this responsibility. The requirement to

have signed agreements among

employers and all service agents has

been deleted.

In response to a comment, we have

deleted the word ‘‘secure’’ from

paragraph (c), since we agree that

control of access is the key point. One

comment suggested that service agents

should have up to five business days to

get information to employers who are

being audited. In our view, each DOT

agency’s rules and inspection practices

should determine how quickly an

employer must produce records. The

service agent is responsible for meeting

the employer’s need to comply with

DOT agency requirements.

Subpart Q—Roles and Responsibilities

of Service Agents

Section 40.341 Must Service Agents

Comply With DOT Drug and Alcohol

Testing Requirements?

There was only one comment on the

proposed § 40.341. AC/TPA wanted C/

TPAs to be authorized to act as a DER

and to be required to have a certified

MRO or administrator in charge. For

reasons we have discussed elsewhere,

we are not permitting C/TPAs to act as

DERs. While we think that training and

certification programs for program

administrators are a good idea, we do

not believe that it is necessary to make

them mandatory at this point.

Section 40.343 What Tasks May a

Service Agent Perform for An Employer?

This is a new section that makes the

basic point that service agents can

perform for employers those functions

authorized by DOT rules. Proposed

§ 40.343 dealt with a different issue.

DOT has become aware of reports that,

particularly in some industries, service

agents have imposed requirements on

covered entities that exceed the

requirements of DOT rules. Some

service agents have made compliance

with these extra requirements a

condition of approval of an employer’s

DOT drug and alcohol testing program.

The proposed section was intended

specifically to prevent excesses of this

kind.

There were few comments on the

proposed section. One said that service

agents work for employers in capacities

other than compliance with DOT rules.

This is doubtless true, but is an issue

outside the scope of this rulemaking.

One commenter suggested that there

was a reverse problem, in that

sometimes employers asked service

agents (e.g., SAPs) to perform tasks

beyond what DOT rules require (e.g.,

make fitness for duty decisions). We

have strengthened language elsewhere

in Part 40 to emphasize that it is

inappropriate to call on SAPs to make

these decisions for employers. A third

commenter was concerned that the

section might inhibit the ability of

service agents to advise employers to

recommend provisions not covered by

DOT rules. Service agents can

recommend provisions not covered by

DOT rules, but they cannot make

adoption of these recommendations a

condition of approving employers’ plans

for DOT compliance purposes.

The Department has relocated this

provision to § 40.355(l).

Section 40.345 In What Circumstances

May a C/TPA Act as an Intermediary in

the Transmission of Drug and Alcohol

Testing Information to Employers?

The proposed § 40.345 made the point

that a service agent that did not comply

with DOT regulations was subject to PIE

proceedings. Comments to this proposal

were along the lines of comments on the

PIE proposal itself, to which we

responded in the ‘‘Principal Policy

Issues’’ section of the preamble. The

substance of this proposed section has

been incorporated in § 40.341 of the

final rule.

The new § 40.345 incorporates the

Department’s decision, discussed at

length under ‘‘Principal Policy Issues,’’

to permit employers to use C/TPAs for

a variety of information transmission

functions, such as passing drug and

alcohol test results from MROs or BATs

to employers. We emphasize four

points. First, with respect to any and all

of the functions that C/TPAs may

perform, the employer has the choice of

using a C/TPA as an intermediary or

getting the information directly from the

party (e.g., the MRO) who generates the

information. Second, we direct readers’

attention to Appendix F. C/TPAs may

act as intermediaries only with respect

to the functions listed in Appendix F.

Third, when C/TPAs act as an

intermediary, they must meet all

requirements (e.g., concerning

confidentiality and timing) that would

apply if the party generating the

information (e.g., an MRO or collector)

sent the information directly to the

employer. For example, if a C/TPA

transmits the MRO’s drug testing results

to DERs, it must transmit each drug test

result to the DER in compliance with

the requirements for MROs set forth in

§ 40.167. Fourth, as noted in connection

with § 40.15, employers remain fully

79512 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

responsible for receiving all information

and taking all actions required under

Part 40 and other DOT agency rule.

Section 40.347 What Functions May

C/TPAs Perform With Respect to

Administering Testing?

One comment on this section

suggested that it refer to C/TPAs

specifically, rather than service agents

generally, because the content of the

section covered functions that C/TPAs

perform and other service agents (e.g.,

MROs, laboratories) either should not or

typically do not perform. We agree with

this comment, and we have changed the

language of the section accordingly.

Another commenter appeared to be

confused about the provision telling

service agents not to select employees

randomly for testing from a ‘‘follow-up’’

pool. This point—which applies to

employers as well as C/TPAs—is that

follow-up tests are scheduled

individually for employees who have

returned to safety-sensitive duties after

a violation, consistent with the SAP’s

plan. It is never appropriate to put

returned employees into a pool and

select them randomly for follow-up

testing. Employees never get advance

notice of the time of a follow-up test,

but follow-up testing is in no way

random. On the other hand, in addition

to being subject to follow-up testing,

returned employees must be in the

regular random testing pool, and are

subject to selection for random testing

on the same basis as all other covered

employees.

Section 40.349 What Records May a

Service Agent Receive and Maintain?

Some commenters on this section

were concerned that because the

proposed rule used the general term

‘‘service agent’’ in this section, the

section glossed over restrictions on the

activities of MROs and laboratories.

They suggested that, as in the case of

§ 40.347, we limit the section to

C/TPAs. While we agree that C/TPAs

perform many record management

functions, it does not appear to us that

the provisions of this section apply only

to C/TPAs. However, in response to the

commenters’ concerns, we are prefacing

this section with an ‘‘except where

otherwise specified in this part’’

statement (we did the same in § 40.347).

The import of this language is that,

where MRO, laboratory, or other

provisions of the rule impose

requirements or restrictions beyond

those of this section, those requirements

or restrictions control.

Another comment suggested

clarifying that DOT access to service

agent records and facilities does not

apply to records and facilities not

involved in the DOT drug and alcohol

testing program. This point seems clear

on the face of the proposed and final

provisions, so we will not restate the

obvious. Another comment objected to

requiring this access, and asked for a

justification. This is equally obvious: in

order to maintain proper oversight of an

important safety program, the

Department needs access to the records

and facilities of those who actually

perform program tasks.

Section 40.351 What Confidentiality

Requirements Apply to Service Agents?

This section is also based on parts of

proposed § 40.349. A number of

comments pertained to proposed

§ 40.349(e), relating to handling of the

CCF. There is no equivalent to this

proposed paragraph in the final rule. A

few comments also supported allowing

‘‘blanket’’ releases of information. As

under the present rule, we believe that

blanket releases compromise the

confidentiality of employee-specific

records and are subject to abuse. The

final rule continues this prohibition.

§ 40.353 What Principles Govern the

Interaction Between MROs and Other

Service Agents?

This section is based on § 40.351 of

the NPRM. Much of the comment

concerned the discretion of C/TPAs,

acting as an intermediary, to transmit

laboratory results to MRO and MRO

verification decisions to the employer.

As discussed in ‘‘Principal Policy

Issues’’ and in connection with § 40.345,

the final rule permits the latter and

prohibits the former.

Some commenters appeared to believe

that the proposed section required

MROs to exercise full-time, in-person,

over-the-shoulder supervision of their

staffs. This is not the case. As long as

MROs really supervise their staff, this

supervision need not always take place

at the same site. We are aware that MRO

operations may have more than one site

and that an MRO cannot be everywhere

at once. On the other hand, the rule is

intended to prohibit C/TPA staff,

working on their own or under C/TPA

rather than MRO supervision, from

performing MRO staff functions.

To reduce paperwork, we have

deleted a proposed requirement for

written agreements between MROs and

other service agents.

§ 40.355 What Limitations Apply to

the Activities of Service Agents?

Some commenters on this section

favored allowing C/TPAs to act as DERs

and to act as an intermediary in

transmitting results from laboratories to

MROs. Another commenter opposed

any ‘‘firewalls’’ between C/TPAs and

MROs. As we have explained above, the

final rule does not permit C/TPAs to act

as DERs or to transmit laboratory results

to MROs. In our view, some firewalls

between MROs and other participants in

the testing process are essential to

maintaining the necessary

independence of MROs.

Another commenter said that

employers, not SAPs, should make

follow-up testing determinations. SAPs

are used in the return-to-duty process

because of their expertise in evaluating

individuals with drug and alcohol

problems. We believe that their

expertise should be used to determine

follow-up testing requirements.

Employers may know their workers, of

course, but they are not typically

experts in drug and alcohol abuse

evaluation and treatment.

One commenter suggested adding a

sentence specifying that MROs could

determine that an individual had

refused a test, in the context of an

adulteration or substitution finding. We

agree, and we have added this language.

We have added a paragraph

concerning a problem that the

Department has occasionally

encountered. It states that service agents

must not intentionally delay the

transmission of drug or alcohol testingrelated documents because of a payment

dispute or other reasons. Parties can

work out disputes among themselves,

but it is essential to the safety purposes

of this program that drug and alcohol

testing results and other information

flow freely. As a safety matter, this

information must not be held hostage to

business disagreements.

Subpart R—Public Interest Exclusions

The Department discussed PIEs

extensively in the ‘‘Principal Policy

Issues’’ portion of the preamble. We will

not repeat this discussion here, focusing

instead on points in the individual

sections of Subpart R that should be

highlighted.

§ 40.361 What Is The Purpose of a

Public Interest Exclusion (PIE)?

Section 40.363 On What Basis May the

Department Issue a PIE?

Section 40.365 What Is the

Department’s Policy Concerning

Starting a PIE Proceeding?

These sections emphasize that the

basic purpose of PIEs is to protect the

public from serious noncompliance on

the part of service agents. PIEs are not

an exclusive remedy: We can take other

actions (e.g., sanctions against

employers, referral to the DOT Inspector

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79513

General) if circumstances warrant. The

basic grounds for issuing a PIE are

serious noncompliance with Part 40 or

DOT agency drug and alcohol testing

regulations and failure to cooperate with

DOT oversight and enforcement efforts.

Section 40.365 includes a list

illustrating the kinds of misconduct that

we believe warrant initiating a PIE

proceeding. We emphasize that this is

not an exhaustive or exclusive list. We

can and will initiate PIEs on the basis

of other fact situations, if warranted.

However, this list should give interested

persons a good idea of the Department’s

policy concerning the level of

seriousness that we intend to be the

basis for PIE actions. The items on the

list all concern such matters as safety,

the outcomes of test results, privacy and

confidentiality, due process and fairness

for employees, the honesty and integrity

of the testing program, and cooperation

with or provision of information to DOT

agency representatives. Many of the

items are drawn from problems the

Department has noted under the

existing Part 40.

We note that the PIE provisions of the

rule are not intended to have retroactive

effect. That is, the Department would

not initiate a PIE proceeding on the

basis of conduct that occurred before the

PIE provisions took effect.

Section 40.367 Who Initiates a PIE

Proceeding?

Section 40.369 What Is the Discretion

of an Initiating Official in Starting a PIE

Proceeding?

Section 40.371 On What Information

Does an Initiating Official Rely in

Deciding Whether To Start a PIE

Proceeding?

Section 40.411 What Is the Role of the

DOT Inspector General’s Office?

These sections concern the

Department’s decision about whether to

begin a PIE proceeding. Only selected

DOT officials are authorized to begin

such a proceeding: DOT agency drug

and alcohol program managers, an

official of ODAPC other than the

Director (who, as the decisionmaker, is

precluded from any role in initiating or

prosecuting a PIE proceeding), or the

designee of these officials. We

emphasize that individual inspectors

and subordinate staff members, while

they may provide information to

initiating officials, are not themselves

authorized to initiate PIE proceedings.

Initiating officials have broad

discretion in deciding whether to start

a PIE proceeding, though this discretion

must be exercised with the policy

expressed § 40.365 in mind. DOT is

never required to start a PIE proceeding.

An initiating official can take into

account such factors as his or her

judgment of the seriousness of the

matter and the availability of resources

to investigate and prosecute a matter

adequately.

An initiating official can rely on

credible information from any source in

deciding whether to start a proceeding.

As many commenters requested, the

initiating official will make an informal

contact with the service agent before

sending a correction notice, in an

attempt to determine if the service agent

has any information that would help the

initiating official make his or her

decision to initiate a proceeding.

While the DOT inspector general (IG)

is not an initiating official in the PIE

process, the IG can investigate

complaints concerning waste, fraud, and

abuse in the drug and alcohol testing

program. The initiating official can use

information from IG investigations and

audits as the basis to begin a PIE

proceeding. The IG can also take action

leading to criminal or civil action

against a service agent or employer if

the facts warrant.

Section 40.373 Before Starting a PIE

Proceeding, Does the Initiating Official

Give the Service Agent an Opportunity

To Correct Problems?

Section 40.375 How Does the Initiating

Official Start a PIE Proceeding?

These sections describe the first

formal steps in any PIE proceeding.

Before taking other action, the initiating

official sends a correction notice,

outlining the compliance problem and

giving the service agent 60 days to

correct it. If the service agent documents

correction of the problem in this period,

the official does not pursue a PIE

proceeding. If not, the official sends a

notice of proposed exclusion (NOPE) to

the service agent, detailing the basis for

the proposed exclusion and informing

the service agent of the next procedural

steps.

There may be some problems that

cannot be corrected, or some

misconduct so serious that subsequent

corrective steps are insufficient to make

up for the effects of noncompliance. For

example, an MRO who has counterfeit

medical credentials probably cannot

correct this problem. A laboratory that

has demonstrated a significant lack of

business integrity by falsifying evidence

or a pattern or practice of careless

conduct resulting in the cancellation of

numerous tests might have great

difficulty demonstrating that it has

made adequate changes to make up for

the problems it caused. The Department

is not limited, in deciding whether to

initiate a PIE proceeding, to purely

prospective considerations (e.g.,

analogous to the ‘‘imminent [future]

harm’’ standard HHS uses in deciding to

take certification action against a

laboratory). Nor is the Department

required to accept, on face value,

assurances from a service agent that it

has learned its lesson and will comply

in the future. The Department will make

judgments of this kind on a case-by-case

basis.

Section 40.377 Who Decides Whether

To Issue a PIE?

This sections focuses on the role of

the ODAPC Director as decisionmaker.

Section 40.377 articulates the firewall

between the Director and the initiating

official, to ensure impartiality. The

Director can delegate the

decisionmaking role to another official

(e.g., in a case where the Director would

be unavailable to decide the case or

recused himself or herself because of a

potential conflict of interest), who

would then be subject to the same

firewall requirements.

Section 40.379 How Do You Contest

the Issuance of a PIE?

Section 40.381 What Information Do

You Present to Contest the Proposed

Issuance of a PIE?

Section 40.383 What Procedures Apply

if You Contest the Issuance of a PIE?

Section 40.385 Who Bears the Burden

of Proof in a PIE Proceeding?

These sections cover an important

part of the administrative due process

protections built into the PIE provisions

of the rule. Within 30 days of getting a

NOPE, a service agent must contact the

Director and make arrangements to

present information and arguments. If

the service agent asks to meet with the

Director, the Director will schedule a

meeting. At this meeting, or in a written

presentation, the service agent may

provide any arguments or factual

information it believes relevant to the

proposed issuance of a PIE, its scope

and duration. We emphasize that the

opportunity to meet with the Director is

not a ‘‘hearing’’ or ‘‘trial,’’ with formal

rules of evidence. The Director will

consider any relevant evidence and

listen to any witnesses the initiating

official or the service agent presents.

Because the initiating official is the

proponent of the PIE action, he or she

bears the burden of proof (by a

preponderance of the evidence) on all

issues. To justify issuing a PIE, the

Director must find that the service agent

failed or refused to perform drug and/

or alcohol testing services as required by

this part or is in serious noncompliance

79514 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

with a DOT agency drug and alcohol

regulation.

Section 40.387 What Matters Does the

Director Decide Concerning a Proposed

PIE?

Section 40.389 What Factors May the

Director Consider?

Section 40.391 What Is the Scope of a

PIE?

Section 40.393 How Long Does a PIE

Stay in Effect?

Section 40.407 May a Service Agent

Ask To Have a PIE Reduced or

Terminated?

These sections concern what

decisions the Director makes and which

factors the Director considers in

deciding on whether to issue a PIE, as

well as the scope and duration of a PIE.

When the Director receives the NOPE

and the service agent’s response to it,

the Director can dismiss the proceeding

(e.g., for not raising a sufficiently

serious noncompliance issue to warrant

issuing a PIE), remand it to the initiating

official for more fact finding, or

continue with the proceeding.

Whenever a proceeding does go to

decision, the Director would make

determinations concerning disputed

factual issues, whether the facts support

issuing a PIE, and the scope and

duration of a PIE. The factors the

Director considers in making these

decisions include the seriousness of the

noncompliance, the pervasiveness of the

noncompliance within the service

agent’s organization, and the

compliance disposition of the service

agent.

The scope of a PIE was the subject of

many comments. In the final rule, the

initiating official proposes a scope for

the PIE, the service agent can contest the

proposal, and the Director decides what

the scope should be. The general rule is

that a PIE applies to parts of an

organization or types of services that are

affected by the service agent’s

noncompliance. The more pervasive the

misconduct, the broader the scope of the

PIE. The rule text provides several

examples of the Department’s thinking

on how to view the proper scope of a

PIE.

There are also situations in which the

PIE can apply to individual officers or

employees of the service agent, if they

are responsible for the noncompliance

that formed the basis for the PIE. This

provision is intended to prevent

individuals from going into business

under a different business or corporate

name while a PIE remains in effect

against the service agent they worked

for. The same is true of businesses

affiliated with the service agent

concerning which the Department

issued a PIE.

A PIE stays in effect from one to five

years. Like the scope of a PIE, the

duration of a PIE is proposed by the

initiating official, may be contested by

the service agent, and is decided upon

by the ODAPC Director. The Director’s

decision is based on such factors as the

seriousness of the noncompliance on

which the PIE is based and the

continued need to protect employers

and employees from the service agent’s

noncompliance. The Director considers

factors such as those listed in § 40.387

in making this decision.

After a PIE has been in effect for nine

months, the service agent can apply to

have its duration shortened. If the

Director verifies that the sources of

noncompliance have been eliminated

and that all drug or alcohol testingrelated services the service agent would

provide to DOT-regulated employers

will be consistent with the requirements

of this part, the Director may issue a

notice terminating or reducing the PIE.

We emphasize that this process is

limited to the issues of duration and

scope: it is not an appeal or

reconsideration of the decision to issue

the PIE.

Section 40.395 Can You Settle a PIE

Proceeding?

Section 40.397 When Does the Director

Make a PIE Decision?

Section 40.399 How Does the

Department Notify Service Agents of Its

Decision?

Section 40.401 How Does the

Department Notify Employers and the

Public About a PIE?

Section 40.403 Must a Service Agent

Notify Its Clients When the Department

Issues a PIE?

Section 40.405 May the Federal Courts

Review PIE Decisions?

Section 40.413 How Are Notices Sent

to Service Agents?

The next group of provisions concern

the mechanics of making PIE decisions

and informing people about them. The

initiating official and the service agent

can settle a PIE proceeding at any time

before the Director issues a decision.

The Director must concur in the

settlement, which could include, for

example, provisions to ensure

compliance or a period of voluntary

exclusion during which the service

agent agrees not to provide certain

services to DOT-regulated employers

while it fixes noncompliance problems.

The Director is normally responsible

for making a decision within 60 days of

the record of the proceeding being

completed. The Director can extend this

normal decision period for 30 days at a

time for good cause. It is the

Department’s policy to expedite these

important decisions, however. Once the

Director issues a decision, it is a final

administrative action of the Department,

subject, like all such actions, to judicial

review under the Administrative

Procedure Act.

The Director must provide written

notice of a PIE to the service agent,

including a statement of the basis for his

or her decision and the scope and

duration of the PIE. The Department

also informs the public about the PIE

though a web site posting and a Federal

Register notice. We also anticipate

informing employer and testing industry

groups about the action, so that they can

inform their members. The service agent

also has an affirmative responsibility to

inform customers about the PIE, so that

they can obtain services from and

transfer records to other service agents.

Finally, § 40.113 concerns the

mechanics of how notices are sent to

service agents and when they are

deemed to have been received. As a

policy matter, the initiating official will

make reasonable efforts to follow up

with the service agent to ensure that the

service agent has received and

understood the notice.

Section 40.409 What Does the

Issuance of a PIE Mean to

Transportation Employers?

Employers have an affirmative

responsibility to stop using the services

of a service agent that is subject to a PIE.

This obligation begins 90 days after the

Director issues the PIE, to give the

employer time to find another service

provider. The obligation applies to

services provided through an affiliate of

the service agent subject to the PIE as

well as the service agent itself, and it

applies to employers in all DOTregulated industries. It is important to

note that a PIE does not invalidate

otherwise proper drug and alcohol tests

in which the service agent was involved

before, and for 90 days after, the

issuance of the PIE. The rule text spells

out the operation of this provision in

more detail.

Appendices

Appendix A

During the last decade of drug testing,

the Department has not regulated nor

standardized the materials (i.e.,

collection containers, specimen bottles,

etc.) used in DOT-mandated drug

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79515

testing. During the first few years of

drug testing, only one specimen bottle

was required. Subsequent to the

Omnibus Act, split specimen collections

became a requirement for four of the six

DOT agencies. In general, each

laboratory provided to the collection

site or the employer laboratory specific

collection kits, many of which differed

in composition.

The introduction of the split, the fact

that in the pipeline and maritime

industry split collection was an

employer option, and the wide variance

among the laboratories’ kits, resulted in

significant problems and numerous tests

had to be cancelled based on collector

error that, at times, was due to the

differences in the makeup of the kits.

Several years ago, the Department

requested all laboratories to provide

samples of their urine collection kits.

These were reviewed against the then

current regulatory requirements (e.g.,

tamper-evident seals on the bottles,

availability and use of shipping

container seals, collection instructions),

and a majority of kits did not meet the

regulatory requirements. Laboratories

were notified and corrective action was

recommended, but the Department did

not take any specific action to

standardize these kits at that time.

The Department is convinced that the

new requirement for all DOT agencies to

use splits, and the development of a

standard kit, will result in fewer

mistakes and cancellations of drug tests.

In that light, Appendix A spells out

broad criteria for the composition of

urine collection kits.

The requirement for a collection

container should minimize the need to

give the employee both bottles, when

there is no collection container in the

kit, and request the employee to urinate

into only one bottle. In some cases,

employees fill both bottles and

collectors submit these, resulting in

splits that do not reconfirm. In some

cases, the two bottles contained urine of

different colors, but collectors submitted

them anyway.

The requirement that the collection

container and the bottles be wrapped or

sealed in a plastic bag was established

earlier to prevent accusations by the

employee that either the collector or

someone at the collection site

introduced some foreign substance into

the containers, causing a positive result.

The standards specifically spell out that

the collection container needs to be

securely wrapped separately from the

specimen bottles and that the bottles

must be either shrink wrapped or sealed

in plastic bags or may be secured with

other methodology provided that the

tamper-evident mechanism is effective

and easily discernable to the employee.

For example, the use of a tiny

filament between the bottle and the cap

which breaks when the bottle is first

opened may be effective in determining

if the bottle was opened, but only if the

employee has this pointed out to him or

her. Even at that, the employee would

have to look very closely to see if the

filament is or is not attached. Most

collectors will not spend the time to go

through this process and employees can

say they were not really able to tell if

the filament was in place. It is much

easier to defend and remember that a

bottle was wrapped in a plastic bag,

rather than argue that the employee was

or was not specifically shown the

filament or that he or she actually did

or did not see the filament. Conversely,

a bottle that has a paper label.

The use of a leak-resistant plastic bag

has been in place for a number of years,

driven primarily by U.S. Postal Service

and courier and shipping services

requirements as a safety issue related to

transportation of biological specimens.

Under the new standards, the plastic

bags must not only be leak-resistant (no

zip locked bags), but must also be

tamper-evident. In other words, once

the bag is sealed it cannot be opened

without the opening becoming obvious.

Under current rules, there is a

requirement that the shipping container

be sealed with a shipping container seal

that is initialed or signed and dated by

the collector. In the NPRM, we proposed

to use a tamper-evident seal on the

plastic bag instead of the shipping

container, since in many cases,

collectors may collect several specimens

in plastic bags and hold or store them

until they have several which can then

be placed into a shipping contained

which is subsequently sealed. There

were few comments related to the kit,

but laboratories did indicate that when

a shipping container, usually a box,

arrives at the laboratory with a broken

seal, the specimens are tested provided

the specimen bottle seals are intact. To

date, the Department is not aware of any

problems related to this practice.

However, it does call into question the

purpose of the second (shipping

container) seal. The Department’s

position is that if the leak-resistant

plastic bag is tamper-evident, that serves

as the secondary protection, which is

currently ensured by the shipping seal.

The primary concern is, and always

has been, the integrity of the specimen

bottle seals. As long as the integrity of

the specimen bottle seals is intact, the

condition of the shipping container seal

is not relevant. The standards listed in

Appendix A, therefore, do not include

a requirement for a shipping container

or plastic bag seal.

The current regulatory requirement is

that the ‘‘specimens shall be placed in

shipping containers designed to

minimize the possibility of damage

during shipment (e.g., specimen boxes

and/or padded mailers)’’. In many cases,

kits contain cardboard boxes designed

to hold only two bottles for shipment.

In some cases, collection sites may, and

do, place a number of specimens in

plastic bags and then into one large

shipping container or box, and transport

the specimens in that manner. With the

advent of stronger plastics, some

laboratories are requesting collection

sites to transport bottles wrapped in

leak-resistant plastic bags which are

placed into larger plastic envelopes,

contending that because the specimen

bottles are constructed of stronger

plastic, this is an acceptable practice.

The Department has discussed this

issue of transporting specimens with

two of the largest courier services and

both have expressed their concerns

about leakage of urine specimens in

transit and concern for the safety of

their employees. Both courier services

require a watertight primary receptacle

(bottle) and a secondary watertight

container, which in this case would be

the leak-resistant plastic bag. One

courier requires a sturdy outer package

consisting of corrugated fiberboard,

wood, metal, or rigid plastic; Styrofoam

boxes, plastic bags, and paper envelopes

are not acceptable as outer packaging.

The second major courier requires that

the primary container (bottle) meet a

150-pound crush test. If it meets that

test, it may be placed in a leak-resistant

plastic bag or container and then may be

placed in a secondary leak-resistant

plastic envelope without further

packaging. Conversely, if the bottle(s)

does not meet the crush test, it must be

placed into a secondary package, which

meets the 150-pound crush test. The

secondary package may then be placed

into a plastic shipping envelope.

The Department has determined that

current shipping regulations and

requirements are sufficient to ensure

that specimens are shipped in a manner

that will protect them from damage.

Therefore, the standards direct that the

specimen bottles be shipped in

containers that can sufficiently protect

them from damage; the standards do not

specify the type of material or the extent

of weight (crush test) that the shipping

containers should meet. The standards

also permit the specimens to be

transported to a laboratory in the leakresistant plastic bag provided they are

hand-carried by a laboratory courier. In

other words, the courier picks the

79516 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

specimens up in whatever is a

convenient shipping or carrying

container and does not subsequently

place them into a system (automated

transportation, another delivery courier,

or on a plane, railroad, or truck), but

personally delivers them to the

laboratory.

Appendix B

Appendix B is simply a list of the data

elements and format for the semi-annual

laboratory report provided to employers.

Laboratories should follow this format

when they compose these reports.

Appendix D

This appendix identifies the format

and type of information that the MRO

needs to submit to DOT when a split

specimen test fails to reconfirm the

presence of the drug/drug metabolite,

adulterant, or the substitution finding

found in the primary specimen.

There has been a long-standing

practice under the current rule that

when the employee requests a test of the

split specimen and the test of the split

fails to reconfirm the presence of the

drug/drug metabolite that was found in

the primary specimen, or if the split was

not available (i.e., not collected or

leaked in transit), the MRO was required

to report this result to the Department.

The purpose of this report was to

determine if this was an administrative

or collection error (e.g., the primary

bottle and the split bottle were not the

same urine) or if the failure to reconfirm

was one of a technical nature, requiring

review by HHS. Although the majority

of ‘‘failures to reconfirm’’ have been due

to the unavailability of the split

specimen, some of the technical

problems led to the discovery of the

various adulterants that are currently

used to circumvent the testing process.

Based on this, the Department will

continue to require this reporting by the

MRO.

The Department has also decided to

permit an employee to request the test

of the split specimen when the primary

specimen is reported as adulterated or

substituted. Based on that decision, we

have determined that should the split

fail to indicate the adulterant or the

substitution is not supported by the test

of the split or the MRO cancels the test

based on medical evidence, the MRO

needs to report this cancellation to the

Department in the same manner as if it

was a positive result which failed to

reconfirm.

There is not a standard ‘‘report’’ that

the MRO needs to fill out. However, for

consistency of information, Appendix D

provides the format for the information

that the Department needs to fully

assess if there are any technical

problems in the testing process. For ease

of use, the same format can be used for

reporting cancellation of a positive as

well as for adulteration and

substitution.

Appendix E

This Appendix lists the 12 criteria the

Department examines in determining

whether certification organizations

should be accepted under §§ 40.281–

40.283 for participation in the SAP

program. The first eleven items are the

same criteria the Department has used

in evaluating other certification

organizations that are already part of the

program (e.g., ICRC). The twelfth item is

NCCA accreditation, discussed in the

preamble to § 40.281.

Appendix F

This Appendix is a list of the drug

and alcohol testing information

transmission functions that C/TPAs are

authorized to perform (see § 40.345) C/

TPAs may, acting as an intermediary,

transmit the information in the listed

regulatory sections to the DER for an

employer, if the employer chooses to

have the C/TPA do so. These are the

only items that C/TPAs are permitted to

transmit to the employer as an

intermediary. The use of service agent

intermediaries is prohibited in all other

cases, such as transmission of laboratory

drug test results to MROs, the

transmission of SAP reports to

employers, and the transmission of

positive alcohol test results.

In every case, the C/TPA must ensure

that, in transmitting the information, it

meets all requirements (e.g., concerning

confidentiality and timing) that would

apply if the party originating the

information (e.g., an MRO or collector)

sent the information directly to the

employer. For example, if a C/TPA

transmits MROs’ drug testing results to

DERs, you must transmit each drug test

result to the DER in compliance with

the requirements for MROs set forth in

§ 40.157.

Appendix G

The ATF included in Appendix G is

a slight modification of the existing

alcohol testing form. One commenter

suggested that a new alcohol testing

form be developed that incorporated

requirements proposed by the NPRM

(e.g., the name of the DER, whether an

STT used a saliva device). We believe

that a revised form will serve the

program better by allowing us to capture

the necessary information. At the same

time, it will no longer require the

employee to sign in Step 4 if the alcohol

concentration is less than 0.02. This

signature will only be necessary if the

alcohol concentration is 0.02 or higher

on the confirmation test. Consistent

with the CCF, all pages of the form may

be white, with the distribution legend at

the bottom of pages 2 and 3 following

the colors of the current form. The OMB

control number of the new form will be

OMB 2105–0529, the same as for the

current form. Program participants may

start using the form January 18, 2001.

Use of the form will become mandatory

on August 1, 2001.

Regulatory Analyses and Notices

Executive Order 12866 and DOT

Regulatory Policies and Procedures

This rule is a significant rule for

purposes of Executive Order 12866. It is

significant because of its policy

importance and its impact upon sizeable

industries. It is not, however, an

economically significant regulation. It is

a reworking of existing requirements,

imposing few new mandates, and

should not have significant incremental

costs. Because of its multimodal impact

and policy interest to regulated parties

and service agents, it is a significant rule

for purposes of the DOT Regulatory

Policies and Procedures. Throughout

this regulation, we have attempted to

balance the costs of new requirements

with the cost savings accrued through

the elimination of some current

requirements.

Economic Impacts

There are two features of the

regulation that would add new

requirements having economic impacts.

The first is the requirement for validity

testing. As the result of work by HHS

and the laboratories, these protocols are

already in place and are being used by

most laboratories, so we expect the

incremental costs of this requirement to

be modest. The Department believes

that public safety is well-served by these

steps to identify and hold accountable

employees in safety-sensitive positions

who attempt to tamper with the testing

process.

Second, the rule includes additional

training requirements for some service

agents. Errors in the testing process

resulting from lack of training can lead

to increased employer program costs

and increased paperwork required to

document the errors and repeat the

testing process. The rule upgrades

requirements for collectors, MROs, and

SAPs. Well-attended training courses for

MROs already exist, as do some

collector and SAP courses.

At the same time, the Department

anticipates cost savings from some

provisions of the regulation, such as the

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79517

reductions in blind specimen

requirements and mitigation of some

reporting requirements. The additional

training requirements discussed in the

previous paragraphs will help to reduce

costs from errors in the system. For

example, every time a better-trained

collector conducts a collection properly

instead of making a mistake, the costs of

developing memorandums for

correction, preparing laboratory

litigation packages, arbitration or court

proceedings, and reversing personnel

actions are avoided.

The Department has estimated cost

increases and decreases that could be

expected if the proposed rule’s

provisions are made final. It is

important to understand that this is a

big program, touching some 8.34 million

employees working for about 673,413

employers. Around 30,000 individuals

and organizations work as service

agents.

In terms of new costs, the Department

estimates an annual cost of about $1.4

million for validity testing. With respect

to training for SAPs. MROs, BATs,

STTs, and collectors, we anticipate that

annual costs will run about $4 million.

In addition, we estimate that there will

be one-time costs for a variety of

administrative requirements in the first

year of implementation of

approximately $1.93 million.

On the other hand, we anticipate

saving at least $4.3 million per year

from the reduction in blind specimen

testing (the savings will probably be

somewhat greater, because fewer

organizations will be required to submit

blind specimens). By changing the

current quarterly laboratory report

requirement to require a semiannual

report, we anticipate saving another

$2.5 million annually. By permitting

positive, adulterated, and substituted

test results to be faxed rather than sent

by overnight express, we project an

annual $3.3 million saving. These

annual savings are greater than the

additional annual costs we anticipate

for the proposed rule. In total, then, we

estimate that the new rule will result in

about $7.4 million in incremental costs

versus $10.1 million in incremental

savings, compared to the existing rule.

The Department has placed in the

docket for this rulemaking a document

describing the basis for these estimates

in greater detail.

Executive Order 13132 and Federalism

This final rule does not have

sufficient Federalism impacts to warrant

further action under Executive Order

13132. The Department notes that the

provisions of Part 40 are incorporated

by reference in the other DOT agency

drug and alcohol testing regulations,

which have existing pre-emption

provisions in them. Consequently, for

example, a provision of a state or local

law or regulation that conflicted with a

provision of Part 40 could be subject to

pre-emption on the basis of this existing

operating administration authority.

Regulatory Flexibility Act

With respect to the Regulatory

Flexibility Act, the Department certifies

that this rule does not have a significant

economic impact on a substantial

number of small entities, so a

Regulatory Flexibility analysis has not

been prepared. It is clear that the rule

affects large numbers of small entities.

Many thousands of covered employers

are small businesses (e.g., small trucking

companies, small transit authorities), as

are many service agents (e.g.,

occupational health clinics). Given the

small, and overall favorable, net change

in regulatory costs compared to the

present rule, spread over these

thousands of small entitites, the cost

impact per entity is expected to be

negligible.

We have also taken some steps, such

as the reduction in blind specimens, the

reduced frequency of some reports, and

the discretion we have given C/TPAs to

act as intermediaries in some situations,

that should assist small entities in

complying and reduce their burdens.

For the smallest entities (e.g., owneroperators), we have also permitted C/

TPAs to perform some additional

functions. The PIE provision should

reduce costs to small employers as the

result of noncompliance by service

agents. Our ability to create special

provisions for small entities is limited

by the need to have uniform

requirements to ensure safety and

fairness to employees. There must be a

single standard for the accuracy and

integrity of the program and the

protection of legitimate employee

interests that cannot vary with the size

of the employer or service agent.

This rulemaking resulted from a ‘‘610

Review’’ under the Regulatory

Flexibility Act. We have reviewed the

existing program to identify areas in

which the rule can be improved with

the effect of assisting small businesses

to comply in a rational and costeffective manner. In addition to the

general clarification of the program this

rule provides, we have identified some

specific areas (e.g., blind specimen

requirements, the addition of the public

interest exclusion provision, the

reduction in reporting frequencies, the

discretionary use of C/TPAs to transmit

information) that should be particularly

helpful to small regulated employers.

Paperwork Reduction Act

Since the inception of the

Department’s drug and alcohol testing

program, each individual DOT agency

has complied with the requirements of

the Paperwork Reduction Act (PRA) by

submitting a justification to the Office of

Management and Budget (OMB). These

PRA submissions reflected requirements

derived from the respective DOT agency

drug and alcohol regulations as well as

from Part 40. The submissions were

never presented to OMB in a

coordinated fashion, nor were they

reviewed together to ensure that all drug

and alcohol program requirements were

reflected in a manner that was

consistent, accurate, and nonduplicative.

In January 2000, the Department

began an effort to evaluate prior PRA

submissions in an attempt to address

disparities between DOT agency

estimates as well as the aggregate

burden and cost estimates. A One-DOT

group was formed. Its goals were to

bring consistency and simplicity to

DOT’s PRA submissions; eliminate PRA

submission duplication between and

among DOT agencies, OST, and other

Federal agencies; eliminate PRA

submission discrepancies; and, more

importantly perhaps, ensure accuracy of

submissions. In addition, the group

decided to standardize cost, hour, and

wage indicators, where possible, and to

identify task commonalities in DOT

agency regulations and standardize how

they are reported to OMB. The group

sought to determine where program

PRA responsibilities for specific drug

and alcohol program elements lie—with

the DOT agencies, OST, or other Federal

agencies.

The group identified a total of 37 PRA

tasks contained in one or more of the

regulations of six DOT agencies (i.e.,

that properly reside in the operating

administration rules rather than in Part

40). Some tasks were shared by all or

some DOT agencies, while other tasks

were peculiar to only one DOT agency.

The operating administrations

subsequently made PRA submissions to

OMB for these items, which OMB

approved. These submissions resulted

in a reduction in the paperwork burden

attributable to operating administration

rules, both because Part 40-related

burdens were kept separate and because

a significant overestimate of the burden

connected with one of the operating

administration programs was corrected.

The total reduction was over 50 million

hours.

Next, the Department constructed a

baseline for the information collection

burden attributable to the existing Part

79518 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

40 (most of which had not previously

been accounted for in PRA submissions

or had been subsumed under operating

administration submissions). This

baseline is approximately 2.23 million

hours. The Department submitted a PRA

request to OMB concerning this

material, which OMB has approved.

Third, the Department compared the

information collection burden of the

existing Part 40 baseline to the

estimated burden for the new Part 40.

Comparing the existing rule to the new

rule, there are some items that increase

(e.g., obtaining test results from

previous employers, MRO review of

negative test documentation, employer

SAP lists being provided to employees),

in part because they previously were

accounted for under operating

administration rules. Other items

decreased (e.g., changing from quarterly

to semi-annual laboratory reports). The

largest decrease resulted from the drug

testing form’s burden hours being

accounted for under the PRA

responsibility of HHS. Cumulatively,

the new Part 40’s information collection

burden is approximately about 842

thousand hours, or about 1.39 million

hours less than that of the existing Part

40.

For informational purposes, the

Department has placed its entire

Paperwork Reduction Act package on

the internet, on the same Docket

Management System web site on which

comments on this rulemaking are

posted. Interested persons may review

this material electronically. The

following web address provides

instructions and access to the DOT

electronic docket: http://dms.dot.gov/

search/. To find the material on the Part

40 rulemaking, just enter the number

6578 in the ‘‘docket number’’ search

dialog box.

In addition, we note that § 40.25,

which requires employers to obtain

information from applicants about

previous drug and alcohol test results,

was not previously the subject of PRArelated comment. While this section is

part of the PRA package OMB has

approved in connection with Part 40,

you may comment about the

information collection aspects of the

section. Please send any comments to

Jim L. Swart, Drug and Alcohol Policy

Advisor, Office of Drug and Alcohol

Policy and Compliance (ODAPC), 400

7th Street, SW., Room 10403,

Washington, DC 20590, 202–366–3784

(voice), 202–366–3897 (fax), or

jim.swart@ost.dot.gov (e-mail).

Other Executive Orders

There are a number of other Executive

Orders that can affect rulemakings.

These include Executive Orders 13084

(Consultation and Coordination with

Indian Tribal Governments), 12988

(Civil Justice Reform), 12875 (Enhancing

the Intergovernmental Partnership),

12630 (Governmental Actions and

Interference with Constitutionally

Protected Property Rights), 12898

(Federal Actions to Address

Environmental Justice in Minority

Populations and Low-Income

Populations), 13045 (Protection of

Children from Environmental Health

Risks and Safety Risks), and 12889

(Implementation of North American

Free Trade Agreement). We have

considered these Executive Orders in

the context of this rule, and we believe

that the rule does not directly affect the

matters that the Executive Orders cover.

We have prepared this rulemaking in

accordance with the Presidential

Directive on Plain Language.

List of Subjects in 49 CFR Part 40

Administrative practice and

procedures, Alcohol abuse, Alcohol

testing, Drug abuse, Drug testing,

Laboratories, Reporting and

recordkeeping requirements, Safety,

Transportation.

Issued this 1st day of December 2000, at

Washington, DC.

Rodney E. Slater,

Secretary of Transportation.

For the reasons set forth in the

preamble, the Department of

Transportation amends 49 CFR subtitle

A as follows:

1. Effective January 18, 2001, amend

the current 49 CFR part 40 as follows:

PART 40—[AMENDED]

a. The authority citation for Part 40 is

revised to read as follows:

Authority: 49 U.S.C. 102, 301, 322, 5331,

20140, 31306, and 45101 et seq.

b. Add Subparts E and F to read as

follows:

Subpart E—Additional Administrative

Provisions and Validity Testing

Sec.

40.201 Additional definitions.

40.203 Who issues authoritative

interpretations of this regulation?

40.205 What is validity testing, and are

laboratories authorized to conduct it?

40.207 What validity tests must laboratories

conduct on primary specimens?

40.209 What criteria do laboratories use to

establish that a specimen is dilute or

substituted?

40.211 What criteria do laboratories use to

establish that a specimen is adulterated?

40.213 How long does the laboratory retain

specimens after testing?

40.215 On what basis does the MRO verify

test results involving adulteration or

substitution?

40.217 What does the second laboratory do

with the split specimen when it is tested

to reconfirm an adulterated test result?

40.219 What does the second laboratory do

with the split specimen when it is tested

to reconfirm a substituted test result?

40.221 What information do laboratories

report to MROs regarding split specimen

results?

40.223 What does the MRO do with split

specimen laboratory results?

40.225 What is a refusal to take a DOT drug

test, and what are the consequences?

Subpart F—Public Interest Exclusions

40.301–40.359 [Reserved]

40.361 What is the purpose of a public

interest exclusion (PIE)?

40.363 On what basis may the Department

issue a PIE?

40.365 What is the Department’s policy

concerning starting a PIE proceeding?

40.367 Who initiates a PIE proceeding?

40.369 What is the discretion of an

initiating official in starting a PIE

proceeding?

40.371 On what information does an

initiating official rely in deciding

whether to start a PIE proceeding?

40.373 Before starting a PIE proceeding,

does the initiating official give the

service agent an opportunity to correct

problems?

40.375 How does the initiating official start

a PIE proceeding?

40.377 Who decides whether to issue a PIE?

40.379 How do you contest the issuance of

a PIE?

40.381 What information do you present to

contest the proposed issuance of a PIE?

40.383 What procedures apply if you

contest the issuance of a PIE?

40.385 Who bears the burden of proof in a

PIE proceeding?

40.387 What matters does the Director

decide concerning a proposed PIE?

40.389 What factors may the Director

consider?

40.391 What is the scope of a PIE?

40.393 How long does a PIE stay in effect?

40.395 Can you settle a PIE proceeding?

40.397 When does the Director make a PIE

decision?

40.399 How does the Department notify

service agents of its decision?

40.401 How does the Department notify

employers and the public about a PIE?

40.403 Must a service agent notify its

clients when the Department issues a

PIE?

40.405 May the Federal courts review PIE

decisions?

40.407 May a service agent ask to have a

PIE reduced or terminated?

40.409 What does the issuance of a PIE

mean to transportation employers?

40.411 What is the role of the DOT

Inspector General’s office?

40.413 How are notices sent to service

agents?

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79519

Subpart E—Additional Administrative

Provisions and Validity Testing

§ 40.201 Additional definitions.

The following definitions apply to the

provisions of this subpart E and subpart

F of this part:

Adulterated specimen. A specimen

that contains a substance that is not

expected to be present in human urine,

or contains a substance expected to be

present but is at a concentration so high

that it is not consistent with human

urine.

Affiliate. Persons are affiliates of one

another if, directly or indirectly, one

controls or has the power to control the

other, or a third party controls or has the

power to control both. Indicators of

control include, but are not limited to:

interlocking management or ownership;

shared interest among family members;

shared facilities or equipment; or

common use of employees. Following

the issuance of a public interest

exclusion, an organization having the

same or similar management,

ownership, or principal employees as

the service agent concerning whom a

public interest exclusion is in effect is

regarded as an affiliate. This definition

is used in connection with the public

interest exclusion procedures of Subpart

F of this part.

Confirmation (or confirmatory)

validity test. A second test performed on

a urine specimen to further support a

validity test result.

Dilute specimen. A specimen with

creatinine and specific gravity values

that are lower than expected for human

urine.

Initial validity test. The first test used

to determine if a specimen is

adulterated, diluted, or substituted.

Office of Drug and Alcohol Policy and

Compliance (ODAPC). The office in the

Office of the Secretary, DOT, that is

responsible for coordinating drug and

alcohol testing program matters within

the Department and providing

information concerning the

implementation of this part.

Split specimen. In drug testing, a part

of the urine specimen that is sent to a

first laboratory and retained unopened,

and which is transported to a second

laboratory in the event that the

employee requests that it be tested

following a verified positive test of the

primary specimen or a verified

adulterated or substituted test result.

Substituted specimen. A specimen

with creatinine and specific gravity

values that are so diminished that they

are not consistent with human urine.

§ 40.203 Who issues authoritative

interpretations of this regulation?

ODAPC and the DOT Office of

General Counsel (OGC) provide written

interpretations of the provisions of this

part. These written DOT interpretations

are the only official and authoritative

interpretations concerning the

provisions of this part. DOT agencies

may incorporate ODAPC/OGC

interpretations in written guidance they

issue concerning drug and alcohol

testing matters.

§ 40.205 What is validity testing, and are

laboratories authorized to conduct it?

(a) Specimen validity testing is the

evaluation of the specimen to determine

if it is consistent with normal human

urine. The purpose of validity testing is

to determine whether certain

adulterants or foreign substances were

added to the urine, if the urine was

diluted, or if the specimen was

substituted.

(b) As a laboratory, you are authorized

to conduct validity testing.

§ 40.207 What validity tests must

laboratories conduct on primary

specimens?

As a laboratory, if you conduct

validity testing under the authorization

of § 40.205(b), you must conduct it in

accordance with the requirements of

this section.

(a) You must test each primary

specimen for creatinine. You must also

determine its specific gravity if you find

that the creatinine concentration is less

than 20 mg/dL.

(b) You must measure the pH of each

primary specimen.

(c) You must test each primary

specimen to determine if it contains

substances that may be used to

adulterate the specimen. Your tests

must have the capability of determining

whether any substance identified in

current HHS requirements or specimen

validity guidance is present in the

specimen.

(d) If you suspect the presence of an

interfering substance/adulterant that

could make a test result invalid, but you

are unable to identify it (e.g., a new

adulterant), you may, as the first

laboratory, send the specimen to

another HHS certified laboratory that

has the capability of doing so.

(e) If you identify a substance in a

specimen that appears to be an

adulterant, but which is not listed in

current HHS requirements or guidance,

you must report the finding in writing

to ODAPC and the Division of

Workplace Programs, HHS, within three

business days. You must also complete

testing of the specimen for drugs, to the

extent technically feasible.

(f) You must conserve as much as

possible of the specimen for possible

future testing.

§ 40.209 What criteria do laboratories use

to establish that a specimen is dilute or

substituted?

(a) As a laboratory you must consider

the primary specimen to be dilute if the

creatinine concentration is less than 20

mg/dL and the specific gravity is less

than 1.003, unless the criteria for a

substituted specimen are met.

(b) As a laboratory you must consider

the primary specimen to be substituted

if the creatinine concentration is less

than or equal to 5 mg/dL and the

specific gravity is less than or equal to

1.001 or greater than or equal to 1.020.

§ 40.211 What criteria do laboratories use

to establish that a specimen is adulterated?

(a) As a laboratory, you must consider

the primary specimen to be adulterated

if you determine that—

(1) A substance that is not expected to

be present in human urine is identified

in the specimen;

(2) A substance that is expected to be

present in human urine is identified at

a concentration so high that it is not

consistent with human urine; or

(3) The physical characteristics of the

specimen are outside the normal

expected range for human urine.

(b) In making your determination

under paragraph (a) of this section, you

must apply the criteria in current HHS

requirements or specimen validity

guidance.

§ 40.213 How long does the laboratory

retain specimens after testing?

(a) As a laboratory testing the primary

specimen, you must retain a specimen

that was reported with positive,

adulterated, substituted, or invalid

results for a minimum of one year.

(b) You must keep such a specimen in

secure, long-term, frozen storage in

accordance with HHS requirements.

(c) Within the one-year period, the

MRO, the employee, the employer, or a

DOT agency may request in writing that

you retain a specimen for an additional

period of time (e.g., for the purpose of

preserving evidence for litigation or a

safety investigation). If you receive such

a request, you must comply with it. If

you do not receive such a request, you

may discard the specimen at the end of

the year.

(d) If you have not sent the split

specimen to another laboratory for

testing, you must retain the split

specimen for an employee’s test for the

same period of time that you retain the

primary specimen and under the same

storage conditions.

79520 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

(e) As the laboratory testing the split

specimen, you must meet the

requirements of paragraphs (a) through

(c) of this section with respect to the

split specimen.

§ 40.215 On what basis does the MRO

verify test results involving adulteration or

substitution?

(a) As an MRO, when you receive a

laboratory report that a specimen is

adulterated or substituted, you must

treat that report in the same way you

treat the laboratory’s report of a

confirmed positive test for a drug or

drug metabolite.

(b) You must follow the same

procedures used for verification of a

confirmed positive test for a drug or

drug except as otherwise provided in

this section.

(c) In the verification interview, you

must explain the laboratory findings to

the employee and address technical

questions or issues the employee may

raise.

(d) You must offer the employee the

opportunity to present a legitimate

medical explanation for the laboratory

findings with respect to presence of the

adulterant in, or the creatinine and

specific gravity findings for, the

specimen.

(e) The employee has the burden of

proof that there is a legitimate medical

explanation.

(1) To meet this burden in the case of

an adulterated specimen, the employee

must demonstrate that the adulterant

found by the laboratory entered the

specimen through physiological means.

(2) To meet this burden in the case of

a substituted specimen, the employee

must demonstrate that he or she did

produce or could have produced urine,

through physiological means, meeting

the creatinine and specific gravity

criteria of § 40.209(b).

(3) The employee must present

information meeting this burden at the

time of the verification interview. As the

MRO, you have discretion to extend the

time available to the employee for this

purpose for up to five days before

verifying the specimen, if you determine

that there is a reasonable basis to believe

that the employee will be able to

produce relevant evidence supporting a

legitimate medical explanation within

that time.

(f) As the MRO or the employer, you

are not responsible for arranging,

conducting, or paying for any studies,

examinations or analyses to determine

whether a legitimate medical

explanation exists.

(g) As the MRO, you must exercise

your best professional judgment in

deciding whether the employee has

established a legitimate medical

explanation.

(1) If you determine that the

employee’s explanation does not

present a reasonable basis for

concluding that there may be a

legitimate medical explanation, you

must report the test to the DER as a

verified refusal to test because of

adulteration or substitution, as

applicable.

(2) If you believe that the employee’s

explanation may present a reasonable

basis for concluding that there is a

legitimate medical explanation, you

must direct the employee to obtain,

within the five-day period set forth in

paragraph (e)(3) of this section, a further

medical evaluation. This evaluation

must be performed by a licensed

physician (the ‘‘referral physician’’),

acceptable to you, with expertise in the

medical issues raised by the employee’s

explanation. (The MRO may perform

this evaluation if the MRO has

appropriate expertise.)

(i) As the MRO or employer, you are

not responsible for finding or paying a

referral physician. However, on request

of the employee, you must provide

reasonable assistance to the employee’s

efforts to find such a physician. The

final choice of the referral physician is

the employee’s, as long as the physician

is acceptable to you.

(ii) As the MRO, you must consult

with the referral physician, providing

guidance to him or her concerning his

or her responsibilities under this

section. As part of this consultation, you

must provide the following information

to the referral physician:

(A) That the employee was required to

take a DOT drug test, but the laboratory

reported that the specimen was

adulterated or substituted, which is

treated as a refusal to test;

(B) The consequences of the

appropriate DOT agency regulation for

refusing to take the required drug test;

(C) That the referral physician must

agree to follow the requirements of

paragraphs (g)(3) through (g)(4) of this

section; and

(D) That the referral physician must

provide you with a signed statement of

his or her recommendations.

(3) As the referral physician, you must

evaluate the employee and consider any

evidence the employee presents

concerning the employee’s medical

explanation. You may conduct

additional tests to determine whether

there is a legitimate medical

explanation. Any additional urine tests

must be performed in an HHS-certified

laboratory.

(4) As the referral physician, you must

then make a written recommendation to

the MRO about whether the MRO

should determine that there is a

legitimate medical explanation. As the

MRO, you must seriously consider and

assess the referral physician’s

recommendation in deciding whether

there is a legitimate medical

explanation.

(5) As the MRO, if you determine that

there is a legitimate medical

explanation, you must cancel the test

and inform ODAPC in writing of the

determination and the basis for it (e.g.,

referral physician’s findings, evidence

produced by the employee).

(6) As the MRO, if you determine that

there is not a legitimate medical

explanation, you must report the test to

the DER as a verified refusal to test

because of adulteration or substitution.

(h) The following are examples of

types of evidence an employee could

present to support an assertion of a

legitimate medical explanation for a

substituted result:

(1) Medically valid evidence

demonstrating that the employee is

capable of physiologically producing

urine meeting the creatinine and

specific gravity criteria of § 40.209(b).

(i) To be regarded as medically valid,

the evidence must have been gathered

using appropriate methodology and

controls to ensure its accuracy and

reliability.

(ii) Assertion by the employee that his

or her personal characteristics (e.g., with

respect to race, gender, weight, diet,

working conditions) are responsible for

the substituted result does not, in itself,

constitute a legitimate medical

explanation. To make a case that there

is a legitimate medical explanation, the

employee must present evidence

showing that the cited personal

characteristics actually result in the

physiological production of urine

meeting the creatinine and specific

gravity criteria of § 40.209 (b).

(2) Information from a medical

evaluation under paragraph (g) of this

section that the individual has a

medical condition that has been

demonstrated to cause the employee to

physiologically produce urine meeting

the creatinine and specific gravity

criteria of § 40.209(b).

(i) A finding or diagnosis by the

physician that an employee has a

medical condition, in itself, does not

constitute a legitimate medical

explanation.

(ii) To establish there is a legitimate

medical explanation, the employee must

demonstrate that the cited medical

condition actually results in the

physiological production of urine

meeting the creatinine and specific

gravity criteria of § 40.209(b).

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79521

§ 40.217 What does the second laboratory

do with the split specimen when it is tested

to reconfirm an adulterated test result?

As the laboratory testing the split

specimen, you must test the split

specimen for the adulterant detected in

the primary specimen using the same

criteria that were used for the primary

specimen or HHS guidance, as

applicable. The result of the primary

specimen is reconfirmed if the split

specimen meets these criteria.

§ 40.219 What does the second laboratory

do with the split specimen when it is tested

to reconfirm a substituted test result?

As the laboratory testing the split

specimen, you must test the split

specimen using the criteria of

§ 40.209(b), just as you would do for a

primary specimen. The result of the

primary specimen is reconfirmed if the

split specimen meets these criteria.

§ 40.221 What information do laboratories

report to MROs regarding split specimen

results?

(a) As the laboratory responsible for

testing the split specimen, and you are

using the Federal Testing Custody and

Control Form (CCF) issued by HHS on

June 23, 2000, you must report split

specimen test results in adulteration

and substitution situations by checking

the ‘‘Reconfirmed’’ box or the ‘‘Failed to

Reconfirm’’ box (Step 5(b)) on Copy 1 of

the CCF.

(b) If you check the ‘‘Failed to

Reconfirm’’ box, one of the following

statements must be included (as

appropriate) on the ‘‘Reason’’ line (Step

5(b)):

(1) Drug(s)/metabolite(s) not

detected.’’

(2) ‘‘Adulterant not found within

criteria.’’

(3) ‘‘Specimen not consistent with

substitution criteria [specify creatinine,

specific gravity, or both]’’

(4) ‘‘Specimen not available for

testing.’’

(c ) If you are using the CCF issued

by HHS prior to June 23, 2000, enter the

information referenced in paragraph (b)

(2), (3), or (4) of this section on the

‘‘remarks’’ line.

(d) As the laboratory certifying

scientist, enter your name, sign, and

date the CCF.

§ 40.223 What does the MRO do with split

specimen laboratory results?

As an MRO, you must take the

following actions when a laboratory

reports the following results of split

specimen tests concerning adulterated

or substituted specimens:

(a) Reconfirmed. (1) In the case of a

reconfirmed positive test for a drug or

drug metabolite, report the

reconfirmation to the DER and the

employee.

(2) In the case of a reconfirmed

adulterated or substituted result, report

to the DER and the employee that the

specimen was adulterated or

substituted, either of which constitutes

a refusal to test. Therefore, ‘‘refusal to

test’’ is the final result.

(b) Failed to Reconfirm: Drug(s)/Drug

Metabolite(s) Not Detected. (1) Report to

the DER and the employee that both

tests must be cancelled.

(2) Inform ODAPC of the failure to

reconfirm.

(c) Failed to Reconfirm: Adulterated

or Substituted (as appropriate); Criteria

Not Met. (1) Report to the DER and the

employee that both tests must be

cancelled.

(2) Inform ODAPC of the failure to

reconfirm.

(d) Failed to Reconfirm: Specimen not

Available for Testing. (1) Report to the

DER and the employee that both tests

must be cancelled and the reason for

cancellation.

(2) Direct the DER to ensure the

immediate collection of another

specimen from the employee under

direct observation, with no notice given

to the employee of this collection

requirement until immediately before

the collection.

(3) Inform ODAPC of the failure to

reconfirm.

(e) Enter your name, sign and date the

appropriate copy of the CCF.

(f) Send a legible copy of the

appropriate copy of the CCF (or a signed

and dated letter) to the employer and

keep a copy for your records.

§ 40.225 What is a refusal to take a DOT

drug test, and what are the consequences?

(a) [Reserved]

(b) As an employee, if the MRO

reports that you have a verified

adulterated or substituted test result,

you have refused to take a drug test.

(c) As an employee, if you refuse to

take a drug test, you incur the

consequences specified under DOT

agency regulations for a violation of

those DOT agency regulations.

(d) [Reserved]

(e) [Reserved]

Subpart F—Public Interest Exclusions

§§ 40.301–40.359 [Reserved]

§ 40.361 What is the purpose of a public

interest exclusion (PIE)?

(a) To protect the public interest,

including protecting transportation

employers and employees from serious

noncompliance with DOT drug and

alcohol testing rules, the Department’s

policy is to ensure that employers

conduct business only with responsible

service agents.

(b) The Department therefore uses

PIEs to exclude from participation in

DOT’s drug and alcohol testing program

any service agent who, by serious

noncompliance with this part or other

DOT agency drug and alcohol testing

regulations, has shown that it is not

currently acting in a responsible

manner.

(c) A PIE is a serious action that the

Department takes only to protect the

public interest. We intend to use PIEs

only to remedy situations of serious

noncompliance. PIEs are not used for

the purpose of punishment.

(d) Nothing in this subpart precludes

a DOT agency or the Inspector General

from taking other action authorized by

its regulations with respect to service

agents or employers that violate its

regulations.

§ 40.363 On what basis may the

Department issue a PIE?

(a) If you are a service agent, the

Department may issue a PIE concerning

you if we determine that you have failed

or refused to provide drug or alcohol

testing services consistent with the

requirements of this part or a DOT

agency drug and alcohol regulation.

(b) The Department also may issue a

PIE if you have failed to cooperate with

DOT agency representatives concerning

inspections, complaint investigations,

compliance and enforcement reviews, or

requests for documents and other

information about compliance with this

part or DOT agency drug and alcohol

regulations.

§ 40.365 What is the Department’s policy

concerning starting a PIE proceeding?

(a) It is the Department’s policy to

start a PIE proceeding only in cases of

serious, uncorrected noncompliance

with the provisions of this part,

affecting such matters as safety, the

outcomes of test results, privacy and

confidentiality, due process and fairness

for employees, the honesty and integrity

of the testing program, and cooperation

with or provision of information to DOT

agency representatives.

(b) The following are examples of the

kinds of serious noncompliance that, as

a matter of policy, the Department views

as appropriate grounds for starting a PIE

proceeding. These examples are not

intended to be an exhaustive or

exclusive list of the grounds for starting

a PIE proceeding. We intend them to

illustrate the level of seriousness that

the Department believes supports

starting a PIE proceeding. The examples

follow:

(1) For an MRO, verifying tests

positive without interviewing the

79522 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

employees as required by this part or

providing MRO services without

meeting the qualifications for an MRO

required by this part;

(2) For a laboratory, refusing to

provide information to the Department,

an employer, or an employee as

required by this part; or a pattern or

practice of testing errors that result in

the cancellation of tests. (As a general

matter of policy, the Department does

not intend to initiate a PIE proceeding

concerning a laboratory with respect to

matters on which HHS initiates

certification actions under its laboratory

guidelines.);

(3) For a collector, a pattern or

practice of directly observing collections

when doing so is unauthorized, or

failing or refusing to directly observe

collections when doing so is mandatory;

(4) For collectors, BATs, or STTs, a

pattern or practice of using forms,

testing equipment, or collection kits that

do not meet the standards in this part;

(5) For a collector, BAT, or STT, a

pattern or practice of ‘‘fatal flaws’’ or

other significant uncorrected errors in

the collection process;

(6) For a laboratory, MRO or C/TPA,

failing or refusing to report tests results

as required by this part or DOT agency

regulations;

(7) For a laboratory, falsifying,

concealing, or destroying

documentation concerning any part of

the drug testing process, including, but

not limited to, documents in a

‘‘litigation package’’;

(8) For SAPs, providing SAP services

while not meeting SAP qualifications

required by this part or performing

evaluations without face-to-face

interviews;

(9) For any service agent, maintaining

a relationship with another party that

constitutes a conflict of interest under

this part (e.g., a laboratory that derives

a financial benefit from having an

employer use a specific MRO);

(10) For any service agent,

representing falsely that the service

agent or its activities is approved or

certified by the Department or a DOT

agency;

(11) For any service agent, disclosing

an employee’s test result information to

any party this part or a DOT agency

regulation does not authorize, including

by obtaining a ‘‘blanket’’ consent from

employees or by creating a data base

from which employers or others can

retrieve an employee’s DOT test results

without the specific consent of the

employee;

(12) For any service agent, interfering

or attempting to interfere with the

ability of an MRO to communicate with

the Department, or retaliating against an

MRO for communicating with the

Department;

(13) For any service agent, directing or

recommending that an employer fail or

refuse to implement any provision of

this part; or

(14) With respect to noncompliance

with a DOT agency regulation, conduct

that affects important provisions of

Department-wide concern (e.g., failure

to properly conduct the selection

process for random testing).

§ 40.367 Who initiates a PIE proceeding?

The following DOT officials may

initiate a PIE proceeding:

(a) The drug and alcohol program

manager of a DOT agency;

(b) An official of ODAPC, other than

the Director; or

(c) The designee of any of these

officials.

§ 40.369 What is the discretion of an

initiating official in starting a PIE

proceeding?

(a) Initiating officials have broad

discretion in deciding whether to start

a PIE proceeding.

(b) In exercising this discretion, the

initiating official must consider the

Department’s policy regarding the

seriousness of the service agent’s

conduct (see § 40.365) and all

information he or she has obtained to

this point concerning the facts of the

case. The initiating official may also

consider the availability of the resources

needed to pursue a PIE proceeding.

(c) A decision not to initiate a PIE

proceeding does not necessarily mean

that the Department regards a service

agent as being in compliance or that the

Department may not use other

applicable remedies in a situation of

noncompliance.

§ 40.371 On what information does an

initiating official rely in deciding whether to

start a PIE proceeding?

(a) An initiating official may rely on

credible information from any source as

the basis for starting a PIE proceeding.

(b) Before sending a correction notice

(see § 40.373), the initiating official

informally contacts the service agent to

determine if there is any information

that may affect the initiating official’s

determination about whether it is

necessary to send a correction notice.

The initiating official may take any

information resulting from this contact

into account in determining whether to

proceed under this subpart.

§ 40.373 Before starting a PIE proceeding,

does the initiating official give the service

agent an opportunity to correct problems?

(a) If you are a service agent, the

initiating official must send you a

correction notice before starting a PIE

proceeding.

(b) The correction notice identifies the

specific areas in which you must come

into compliance in order to avoid being

subject to a PIE proceeding.

(c) If you make and document changes

needed to come into compliance in the

areas listed in the correction notice to

the satisfaction of the initiating official

within 60 days of the date you receive

the notice, the initiating official does

not start a PIE proceeding. The initiating

official may conduct appropriate fact

finding to verify that you have made

and maintained satisfactory corrections.

When he or she is satisfied that you are

in compliance, the initiating official

sends you a notice that the matter is

concluded.

§ 40.375 How does the initiating official

start a PIE proceeding?

(a) As a service agent, if your

compliance matter is not correctable

(see § 40.373(a)), or if have not resolved

compliance matters as provided in

§ 40.373(c), the initiating official starts a

PIE proceeding by sending you a notice

of proposed exclusion (NOPE). The

NOPE contains the initiating official’s

recommendations concerning the

issuance of a PIE, but it is not a decision

by the Department to issue a PIE.

(b) The NOPE includes the following

information:

(1) A statement that the initiating

official is recommending that the

Department issue a PIE concerning you;

(2) The factual basis for the initiating

official’s belief that you are not

providing drug and/or alcohol testing

services to DOT-regulated employers

consistent with the requirements of this

part or are in serious noncompliance

with a DOT agency drug and alcohol

regulation;

(3) The factual basis for the initiating

official’s belief that your noncompliance

has not been or cannot be corrected;

(4) The initiating official’s

recommendation for the scope of the

PIE;

(5) The initiating official’s

recommendation for the duration of the

PIE; and

(6) A statement that you may contest

the issuance of the proposed PIE, as

provided in § 40.379.

(c) The initiating official sends a copy

of the NOPE to the ODAPC Director at

the same time he or she sends the NOPE

to you.

§ 40.377 Who decides whether to issue a

PIE?

(a) The ODAPC Director, or his or her

designee, decides whether to issue a

PIE. If a designee is acting as the

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79523

decisionmaker, all references in this

subpart to the Director refer to the

designee.

(b) To ensure his or her impartiality,

the Director plays no role in the

initiating official’s determination about

whether to start a PIE proceeding.

(c) There is a ‘‘firewall’’ between the

initiating official and the Director. This

means that the initiating official and the

Director are prohibited from having any

discussion, contact, or exchange of

information with one another about the

matter, except for documents and

discussions that are part of the record of

the proceeding.

§ 40.379 How do you contest the issuance

of a PIE?

(a) If you receive a NOPE, you may

contest the issuance of the PIE.

(b) If you want to contest the

proposed PIE, you must provide the

Director information and argument in

opposition to the proposed PIE in

writing, in person, and/or through a

representative. To contest the proposed

PIE, you must take one or more of the

steps listed in this paragraph (b) within

30 days after you receive the NOPE.

(1) You may request that the Director

dismiss the proposed PIE without

further proceedings, on the basis that it

does not concern serious

noncompliance with this part or DOT

agency regulations, consistent with the

Department’s policy as stated in

§ 40.365.

(2) You may present written

information and arguments, consistent

with the provisions of § 40.381,

contesting the proposed PIE.

(3) You may arrange with the Director

for an informal meeting to present your

information and arguments.

(c) If you do not take any of the

actions listed in paragraph (b) of this

section within 30 days after you receive

the NOPE, the matter proceeds as an

uncontested case. In this event, the

Director makes his or her decision based

on the record provided by the initiating

official (i.e., the NOPE and any

supporting information or testimony)

and any additional information the

Director obtains.

§ 40.381 What information do you present

to contest the proposed issuance of a PIE?

(a) As a service agent who wants to

contest a proposed PIE, you must

present at least the following

information to the Director:

(1) Specific facts that contradict the

statements contained in the NOPE (see

§ 40.375(b)(2) and (3)). A general denial

is insufficient to raise a genuine dispute

over facts material to the issuance of a

PIE;

(2) Identification of any existing,

proposed or prior PIE; and

(3) Identification of your affiliates, if

any.

(b) You may provide any information

and arguments you wish concerning the

proposed issuance, scope and duration

of the PIE (see § 40.375(b)(4) and (5).

(c) You may provide any additional

relevant information or arguments

concerning any of the issues in the

matter.

§ 40.383 What procedures apply if you

contest the issuance of a PIE?

(a) DOT conducts PIE proceedings in

a fair and informal manner. The Director

may use flexible procedures to allow

you to present matters in opposition.

The Director is not required to follow

formal rules of evidence or procedure in

creating the record of the proceeding.

(b) The Director will consider any

information or argument he or she

determines to be relevant to the decision

on the matter.

(c) You may submit any documentary

evidence you want the Director to

consider. In addition, if you have

arranged an informal meeting with the

Director, you may present witnesses and

confront any person the initiating

official presents as a witness against

you.

(d) In cases where there are material

factual issues in dispute, the Director or

his or her designee may conduct

additional fact-finding.

(e) If you have arranged a meeting

with the Director, the Director will make

a transcribed record of the meeting

available to you on your request. You

must pay the cost of transcribing and

copying the meeting record.

§ 40.385 Who bears the burden of proof in

a PIE proceeding?

(a) As the proponent of issuing a PIE,

the initiating official bears the burden of

proof.

(b) This burden is to demonstrate, by

a preponderance of the evidence, that

the service agent was in serious

noncompliance with the requirements

of this part for drug and/or alcohol

testing-related services or with the

requirements of another DOT agency

drug and alcohol testing regulation.

§ 40.387 What matters does the Director

decide concerning a proposed PIE?

(a) Following the service agent’s

response (see § 40.379(b)) or, if no

response is received, after 30 days have

passed from the date on which the

service agent received the NOPE, the

Director may take one of the following

steps:

(1) In response to a request from the

service agent (see § 40.379(b)(1)) or on

his or her own motion, the Director may

dismiss a PIE proceeding if he or she

determines that it does not concern

serious noncompliance with this part or

DOT agency regulations, consistent with

the Department’s policy as stated in

§ 40.365.

(i) If the Director dismisses a

proposed PIE under this paragraph (a),

the action is closed with respect to the

noncompliance alleged in the NOPE.

(ii) The Department may initiate a

new PIE proceeding against you on the

basis of different or subsequent conduct

that is in noncompliance with this part

or other DOT drug and alcohol testing

rules.

(2) If the Director determines that the

initiating official’s submission does not

have complete information needed for a

decision, the Director may remand the

matter to the initiating official. The

initiating official may resubmit the

matter to the Director when the needed

information is complete. If the basis for

the proposed PIE has changed, the

initiating official must send an amended

NOPE to the service agent.

(b) The Director makes determinations

concerning the following matters in any

PIE proceeding that he or she decides on

the merits:

(1) Any material facts that are in

dispute;

(2) Whether the facts support issuing

a PIE;

(3) The scope of any PIE that is

issued; and

(4) The duration of any PIE that is

issued.

§ 40.389 What factors may the Director

consider?

This section lists examples of the kind

of mitigating and aggravating factors

that the Director may consider in

determining whether to issue a PIE

concerning you, as well as the scope

and duration of a PIE. This list is not

exhaustive or exclusive. The Director

may consider other factors if

appropriate in the circumstances of a

particular case. The list of examples

follows:

(a) The actual or potential harm that

results or may result from your

noncompliance;

(b) The frequency of incidents and/or

duration of the noncompliance;

(c) Whether there is a pattern or prior

history of noncompliance;

(d) Whether the noncompliance was

pervasive within your organization,

including such factors as the following:

(1) Whether and to what extent your

organization planned, initiated, or

carried out the noncompliance;

(2) The positions held by individuals

involved in the noncompliance, and

79524 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

whether your principals tolerated their

noncompliance; and

(3) Whether you had effective

standards of conduct and control

systems (both with respect to your own

organization and any contractors or

affiliates) at the time the noncompliance

occurred;

(e) Whether you have demonstrated

an appropriate compliance disposition,

including such factors as the following:

(1) Whether you have accepted

responsibility for the noncompliance

and recognize the seriousness of the

conduct that led to the cause for

issuance of the PIE;

(2) Whether you have cooperated fully

with the Department during the

investigation. The Director may

consider when the cooperation began

and whether you disclosed all pertinent

information known to you;

(3) Whether you have fully

investigated the circumstances of the

noncompliance forming the basis for the

PIE and, if so, have made the result of

the investigation available to the

Director;

(4) Whether you have taken

appropriate disciplinary action against

the individuals responsible for the

activity that constitutes the grounds for

issuance of the PIE; and

(5) Whether your organization has

taken appropriate corrective actions or

remedial measures, including

implementing actions to prevent

recurrence;

(f) With respect to noncompliance

with a DOT agency regulation, the

degree to which the noncompliance

affects matters common to the DOT drug

and alcohol testing program;

(g) Other factors appropriate to the

circumstances of the case.

§ 40.391 What is the scope of a PIE?

(a) The scope of a PIE is the

Department’s determination about the

divisions, organizational elements,

types of services, affiliates, and/or

individuals (including direct employees

of a service agent and its contractors) to

which a PIE applies.

(b) If, as a service agent, the

Department issues a PIE concerning

you, the PIE applies to all your

divisions, organizational elements, and

types of services that are involved with

or affected by the noncompliance that

forms the factual basis for issuing the

PIE.

(c) In the NOPE (see § 40.375(b)(4)),

the initiating official sets forth his or her

recommendation for the scope of the

PIE. The proposed scope of the PIE is

one of the elements of the proceeding

that the service agent may contest (see

§ 40.381(b)) and about which the

Director makes a decision (see

§ 40.387(b)(3)).

(d) In recommending and deciding the

scope of the PIE, the initiating official

and Director, respectively, must take

into account the provisions of

paragraphs (e) through (j) of this section.

(e) The pervasiveness of the

noncompliance within a service agent’s

organization (see § 40.389(d)) is an

important consideration in determining

the scope of a PIE. The appropriate

scope of a PIE grows broader as the

pervasiveness of the noncompliance

increases.

(f) The application of a PIE is not

limited to the specific location or

employer at which the conduct that

forms the factual basis for issuing the

PIE was discovered.

(g) A PIE applies to your affiliates, if

the affiliate is involved with or affected

by the conduct that forms the factual

basis for issuing the PIE.

(h) A PIE applies to individuals who

are officers, employees, directors,

shareholders, partners, or other

individuals associated with your

organization in the following

circumstances:

(1) Conduct forming any part of the

factual basis of the PIE occurred in

connection with the individual’s

performance of duties by or on behalf of

your organization; or

(2) The individual knew of, had

reason to know of, approved, or

acquiesced in such conduct. The

individual’s acceptance of benefits

derived from such conduct is evidence

of such knowledge, acquiescence, or

approval.

(i) If a contractor to your organization

is solely responsible for the conduct that

forms the factual basis for a PIE, the PIE

does not apply to the service agent itself

unless the service agent knew or should

have known about the conduct and did

not take action to correct it.

(j) PIEs do not apply to drug and

alcohol testing that DOT does not

regulate.

(k) The following examples illustrate

how the Department intends the

provisions of this section to work:

Example 1 to § 40.391. Service Agent P

provides a variety of drug testing services. P’s

SAP services are involved in a serious

violation of this Part 40. However, P’s other

services fully comply with this part, and P’s

overall management did not plan or concur

in the noncompliance, which in fact was

contrary to P’s articulated standards. Because

the noncompliance was isolated in one area

of the organization’s activities, and did not

pervade the entire organization, the scope of

the PIE could be limited to SAP services.

Example 2 to § 40.391. Service Agent Q

provides a similar variety of services. The

conduct forming the factual basis for a PIE

concerns collections for a transit authority.

As in Example 1, the noncompliance is not

pervasive throughout Q’s organization. The

PIE would apply to collections at all

locations served by Q, not just the particular

transit authority or not just in the state in

which the transit authority is located.

Example 3 to § 40.391. Service Agent R

provides a similar array of services. One or

more of the following problems exists: R’s

activities in several areas—collections,

MROs, SAPs, protecting the confidentiality of

information—are involved in serious

noncompliance; DOT determines that R’s

management knew or should have known

about serious noncompliance in one or more

areas, but management did not take timely

corrective action; or, in response to an

inquiry from DOT personnel, R’s

management refuses to provide information

about its operations. In each of these three

cases, the scope of the PIE would include all

aspects of R’s services.

Example 4 to § 40.391. Service Agent W

provides only one kind of service (e.g.,

laboratory or MRO services). The Department

issues a PIE concerning these services.

Because W only provides this one kind of

service, the PIE necessarily applies to all its

operations.

Example 5 to § 40.391. Service Agent X, by

exercising reasonably prudent oversight of its

collection contractor, should have known

that the contractor was making numerous

‘‘fatal flaws’’ in tests. Alternatively, X

received a correction notice pointing out

these problems in its contractor’s collections.

In neither case did X take action to correct

the problem. X, as well as the contractor,

would be subject to a PIE with respect to

collections.

Example 6 to § 40.391. Service Agent Y

could not reasonably have known that one of

its MROs was regularly failing to interview

employees before verifying tests positive.

When it received a correction notice, Y

immediately dismissed the erring MRO. In

this case, the MRO would be subject to a PIE

but Y would not.

Example 7 to § 40.391. The Department

issues a PIE with respect to Service Agent Z.

Z provides services for DOT-regulated

transportation employers, a Federal agency

under the HHS-regulated Federal employee

testing program, and various private

businesses and public agencies that DOT

does not regulate. The PIE applies only to the

DOT-regulated transportation employers with

respect to their DOT-mandated testing, not to

the Federal agency or the other public

agencies and private businesses. The PIE

does not prevent the non-DOT regulated

entities from continuing to use Z’s services.

§ 40.393 How long does a PIE stay in

effect?

(a) In the NOPE (see § 40.375(b)(5)),

the initiating official proposes the

duration of the PIE. The duration of the

PIE is one of the elements of the

proceeding that the service agent may

contest (see § 40.381(b)) and about

which the Director makes a decision

(see § 40.387(b)(4)).

(b) In deciding upon the duration of

the PIE, the Director considers the

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79525

seriousness of the conduct on which the

PIE is based and the continued need to

protect employers and employees from

the service agent’s noncompliance. The

Director considers factors such as those

listed in § 40.389 in making this

decision.

(c) The duration of a PIE will be

between one and five years, unless the

Director reduces its duration under

§ 40.407.

§ 40.395 Can you settle a PIE proceeding?

At any time before the Director’s

decision, you and the initiating official

can, with the Director’s concurrence,

settle a PIE proceeding.

§ 40.397 When does the Director make a

PIE decision?

The Director makes his or her

decision within 60 days of the date

when the record of a PIE proceeding is

complete (including any meeting with

the Director and any additional factfinding that is necessary). The Director

may extend this period for good cause

for additional periods of up to 30 days.

§ 40.399 How does the Department notify

service agents of its decision?

If you are a service agent involved in

a PIE proceeding, the Director provides

you written notice as soon as he or she

makes a PIE decision. The notice

includes the following elements:

(a) If the decision is not to issue a PIE,

a statement of the reasons for the

decision, including findings of fact with

respect to any material factual issues

that were in dispute.

(b) If the decision is to issue a PIE—

(1) A reference to the NOPE;

(2) A statement of the reasons for the

decision, including findings of fact with

respect to any material factual issues

that were in dispute;

(3) A statement of the scope of the

PIE; and

(4) A statement of the duration of the

PIE.

§ 40.401 How does the Department notify

employers and the public about a PIE?

(a) The Department maintains a

document called the ‘‘List of Excluded

Drug and Alcohol Service Agents.’’ This

document may be found on the

Department’s web site (http://

www.dot.gov/ost/dapc). You may also

request a copy of the document from

ODAPC.

(b) When the Director issues a PIE, he

or she adds to the List the name and

address of the service agent, and any

other persons or organizations, to whom

the PIE applies and information about

the scope and duration of the PIE.

(c) When a service agent ceases to be

subject to a PIE, the Director removes

this information from the List.

(d) The Department also publishes a

Federal Register notice to inform the

public on any occasion on which a

service agent is added to or taken off the

List.

§ 40.403 Must a service agent notify its

clients when the Department issues a PIE?

(a) As a service agent, if the

Department issues a PIE concerning

you, you must notify each of your DOTregulated employer clients, in writing,

about the issuance, scope, duration, and

effect of the PIE. You may meet this

requirement by sending a copy of the

Director’s PIE decision or by a separate

notice. You must send this notice to

each client within three working days of

receiving from the Department the

notice provided for in § 40.399(b).

(b) As part of the notice you send

under paragraph (a) of this section, you

must offer to transfer immediately all

records pertaining to the employer and

its employees to the employer or to any

other service agent the employer

designates. You must carry out this

transfer as soon as the employer

requests it.

§ 40.405 May the Federal courts review PIE

decisions?

The Director’s decision is a final

administrative action of the Department.

Like all final administrative actions of

Federal agencies, the Director’s decision

is subject to judicial review under the

Administrative Procedure Act (5 U.S.C.

551 et seq.).

§ 40.407 May a service agent ask to have

a PIE reduced or terminated?

(a) Yes, as a service agent concerning

whom the Department has issued a PIE,

you may request that the Director

terminate a PIE or reduce its duration

and/or scope. This process is limited to

the issues of duration and scope. It is

not an appeal or reconsideration of the

decision to issue the PIE.

(b) Your request must be in writing

and supported with documentation.

(c) You must wait at least nine

months from the date on which the

Director issued the PIE to make this

request.

(d) The initiating official who was the

proponent of the PIE may provide

information and arguments concerning

your request to the Director.

(e) If the Director verifies that the

sources of your noncompliance have

been eliminated and that all drug or

alcohol testing-related services you

would provide to DOT-regulated

employers will be consistent with the

requirements of this part, the Director

may issue a notice terminating or

reducing the PIE.

§ 40.409 What does the issuance of a PIE

mean to transportation employers?

(a) As an employer, you are deemed

to have notice of the issuance of a PIE

when it appears on the List mentioned

in § 40.401(a) or the notice of the PIE

appears in the Federal Register as

provided in § 40.401(d). You should

check this List to ensure that any service

agents you are using or planning to use

are not subject to a PIE.

(b) As an employer who is using a

service agent concerning whom a PIE is

issued, you must stop using the services

of the service agent no later than 90

days after the Department has published

the decision in the Federal Register or

posted it on its web site. You may apply

to the ODAPC Director for an extension

of 30 days if you demonstrate that you

cannot find a substitute service agent

within 90 days.

(c) Except during the period provided

in paragraph (b) of this section, you

must not, as an employer, use the

services of a service agent that are

covered by a PIE that the Director has

issued under this subpart. If you do so,

you are in violation of the Department’s

regulations and subject to applicable

DOT agency sanctions (e.g., civil

penalties, withholding of Federal

financial assistance).

(d) You also must not obtain drug or

alcohol testing services through a

contractor or affiliate of the service

agent to whom the PIE applies.

Example to Paragraph (d). Service Agent R

was subject to a PIE with respect to SAP

services. As an employer, not only must you

not use R’s own SAP services, but you also

must not use SAP services you arrange

through R, such as services provided by a

subcontractor or affiliate of R or a person or

organization that receives financial gain from

its relationship with R.

(e) This section’s prohibition on using

the services of a service agent

concerning which the Director has

issued a PIE applies to employers in all

industries subject to DOT drug and

alcohol testing regulations.

Example to Paragraph (e). The initiating

official for a PIE was the FAA drug and

alcohol program manager, and the conduct

forming the basis of the PIE pertained to the

aviation industry. As a motor carrier, transit

authority, pipeline, railroad, or maritime

employer, you are also prohibited from using

the services of the service agent involved in

connection with the DOT drug and alcohol

testing program.

(f) The issuance of a PIE does not

result in the cancellation of drug or

alcohol tests conducted using the

service agent involved before the

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issuance of the Director’s decision or up

to 90 days following its publication in

the Federal Register or posting on the

Department’s web site, unless otherwise

specified in the Director’s PIE decision

or the Director grants an extension as

provided in paragraph (b) of this

section.

Example to Paragraph (f). The Department

issues a PIE concerning Service Agent N on

September 1. All tests conducted using N’s

services before September 1, and through

November 30, are valid for all purposes

under DOT drug and alcohol testing

regulations, assuming they meet all other

regulatory requirements.

§ 40.411 What is the role of the DOT

Inspector General’s office?

(a) Any person may bring concerns

about waste, fraud, or abuse on the part

of a service agent to the attention of the

DOT Office of Inspector General.

(b) In appropriate cases, the Office of

Inspector General may pursue criminal

or civil remedies against a service agent.

(c) The Office of Inspector General

may provide factual information to

other DOT officials for use in a PIE

proceeding.

§ 40.413 How are notices sent to service

agents?

(a) If you are a service agent, DOT

sends notices to you, including

correction notices, notices of proposed

exclusion, decision notices, and other

notices, in any of the ways mentioned

in paragraph (b) or (c) of this section.

(b) DOT may send a notice to you,

your identified counsel, your agent for

service of process, or any of your

partners, officers, directors, owners, or

joint venturers to the last known street

address, fax number, or e-mail address.

DOT deems the notice to have been

received by you if sent to any of these

persons.

(c) DOT considers notices to be

received by you—

(1) When delivered, if DOT mails the

notice to the last known street address,

or five days after we send it if the letter

is undeliverable;

(2) When sent, if DOT sends the

notice by fax or five days after we send

it if the fax is undeliverable; or

(3) When delivered, if DOT sends the

notice by e-mail or five days after DOT

sends it if the e-mail is undeliverable.

2. Effective August 1, 2001, revise 49

CFR Part 40 to read as follows:

PART 40—PROCEDURES FOR

TRANSPORTATION WORKPLACE

DRUG AND ALCOHOL TESTING

PROGRAMS

Subpart A—Administrative Provisions

Sec.

40.1 Who does this regulation cover?

40.3 What do the terms used in this

regulation mean?

40.5 Who issues authoritative

interpretations of this regulation?

40.7 How can you get an exemption from a

requirement in this regulation?

Subpart B—Employer Responsibilities

40.11 What are the general responsibilities

of employers under this regulation?

40.13 How do DOT drug and alcohol tests

relate to non-DOT tests?

40.15 May an employer use a service agent

to meet DOT drug and alcohol testing

requirements?

40.17 Is an employer responsible for

obtaining information from its service

agents?

40.19 [Reserved]

40.21 May an employer stand down an

employee before the MRO has completed

the verification process?

40.23 What actions do employers take after

receiving verified test results?

40.25 Must an employer check on the drug

and alcohol testing record of employees

it is intending to use to perform safetysensitive duties?

40.27 Where is other information on

employer responsibilities found in this

regulation?

Subpart C—Urine Collection Personnel

40.31 Who may collect urine specimens for

DOT drug testing?

40.33 What training requirements must a

collector meet?

40.35 What information about the DER

must employers provide to collectors?

40.37 Where is other information on the

role of collectors found in this

regulation?

Subpart D—Collection Sites, Forms,

Equipment and Supplies Used in DOT Urine

Collections

40.41 Where does a urine collection for a

DOT drug test take place?

40.43 What steps must operators of

collection sites take to protect the

security and integrity of urine

collections?

40.45 What form is used to document a

DOT urine collection?

40.47 May employers use the CCF for nonDOT collections or non-Federal forms for

DOT collections?

40.49 What materials are used to collect

urine specimens?

40.51 What materials are used to send urine

specimens to the laboratory?

Subpart E—Urine Specimen Collections

40.61 What are the preliminary steps in the

collection process?

40.63 What steps does the collector take in

the collection process before the

employee provides a urine specimen?

40.65 What does the collector check for

when the employee presents a specimen?

40.67 When and how is a directly observed

collection conducted?

40.69 How is a monitored collection

conducted?

40.71 How does the collector prepare the

specimens?

40.73 How is the collection process

completed?

Subpart F—Drug Testing Laboratories

40.81 What laboratories may be used for

DOT drug testing?

40.83 How do laboratories process

incoming specimens?

40.85 What drugs do laboratories test for?

40.87 What are the cutoff concentrations for

initial and confirmation tests?

40.89 What is validity testing, and are

laboratories required to conduct it?

40.91 What validity tests must laboratories

conduct on primary specimens?

40.93 What criteria do laboratories use to

establish that a specimen is dilute or

substituted?

40.95 What criteria do laboratories use to

establish that a specimen is adulterated?

40.97 What do laboratories report and how

do they report it?

40.99 How long does the laboratory retain

specimens after testing?

40.101 What relationship may a laboratory

have with an MRO?

40.103 What are the requirements for

submitting blind specimens to a

laboratory?

40.105 What happens if the laboratory

reports a result different from that

expected for a blind specimen?

40.107 Who may inspect laboratories?

40.109 What documentation must the

laboratory keep, and for how long?

40.111 When and how must a laboratory

disclose statistical summaries and other

information it maintains?

40.113 Where is other information

concerning laboratories found in this

regulation?

Subpart G—Medical Review Officers and

the Verification Process

40.121 Who is qualified to act as an MRO?

40.123 What are the MRO’s responsibilities

in the DOT drug testing program?

40.125 What relationship may an MRO

have with a laboratory?

40.127 What are the MRO’s functions in

reviewing negative test results?

40.129 What are the MRO’s functions in

reviewing laboratory confirmed positive,

adulterated, substituted, or invalid drug

test results?

40.131 How does the MRO or DER notify an

employee of the verification process after

a confirmed positive, adulterated,

substituted, or invalid test result?

40.133 Under what circumstances may the

MRO verify a test as positive, or as a

refusal to test because of adulteration or

substitution, without interviewing the

employee?

40.135 What does the MRO tell the

employee at the beginning of the

verification interview?

40.137 On what basis does the MRO verify

test results involving marijuana, cocaine,

amphetamines, or PCP?

40.139 On what basis does the MRO verify

test results involving opiates?

40.141 How does the MRO obtain

information for the verification decision?

40.143 [Reserved]

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79527

40.145 On what basis does the MRO verify

test results involving adulteration or

substitution?

40.147 [Reserved]

40.149 May the MRO change a verified

positive drug test result or refusal to test?

40.151 What are MROs prohibited from

doing as part of the verification process?

40.153 How does the MRO notify

employees of their right to a test of the

split specimen?

40.155 What does the MRO do when a

negative or positive test result is also

dilute?

40.157 [Reserved]

40.159 What does the MRO do when a drug

test result is invalid?

40.161 What does the MRO do when a drug

test specimen is rejected for testing?

40.163 How does the MRO report drug test

results?

40.165 To whom does the MRO transmit

reports of drug test results?

40.167 How are MRO reports of drug results

transmitted to the employer?

40.169 Where is other information

concerning the role of MROs and the

verification process found in this

regulation?

Subpart H—Split Specimen Tests

40.171 How does an employee request a

test of a split specimen?

40.173 Who is responsible for paying for

the test of a split specimen?

40.175 What steps does the first laboratory

take with a split specimen?

40.177 What does the second laboratory do

with the split specimen when it is tested

to reconfirm the presence of a drug or

drug metabolite?

40.179 What does the second laboratory do

with the split specimen when it is tested

to reconfirm an adulterated test result?

40.181 What does the second laboratory do

with the split specimen when it is tested

to reconfirm a substituted test result?

40.183 What information do laboratories

report to MROs regarding split specimen

results?

40.185 Through what methods and to

whom must a laboratory report split

specimen results?

40.187 What does the MRO do with split

specimen laboratory results?

40.189 Where is other information

concerning split specimens found in this

regulation?

Subpart I—Problems in Drug Tests

40.191 What is a refusal to take a DOT drug

test, and what are the consequences?

40.193 What happens when an employee

does not provide a sufficient amount of

urine for a drug test?

40.195 What happens when an individual

is unable to provide a sufficient amount

of urine for a pre-employment or returnto-duty test because of a permanent or

long-term medical condition?

40.197 What happens when an employer

receives a report of a dilute specimen?

40.199 What problems always cause a drug

test to be cancelled?

40.201 What problems always cause a drug

test to be cancelled and may result in a

requirement for another collection?

40.203 What problems cause a drug test to

be cancelled unless they are corrected?

40.205 How are drug test problems

corrected?

40.207 What is the effect of a cancelled

drug test?

40.209 What is the effect of procedural

problems that are not sufficient to cancel

a drug test?

Subpart J—Alcohol Testing Personnel

40.211 Who conducts DOT alcohol tests?

40.213 What training requirements must

STTs and BATs meet?

40.215 What information about the DER do

employers have to provide to BATs and

STTs?

40.217 Where is other information on the

role of STTs and BATs found in this

regulation?

Subpart K—Testing Sites, Forms,

Equipment and Supplies Used in Alcohol

Testing

40.221 Where does an alcohol test take

place?

40.223 What steps must be taken to protect

the security of alcohol testing sites?

40.225 What form is used for an alcohol

test?

40.227 May employers use the ATF for nonDOT tests, or non-DOT forms for DOT

tests?

40.229 What devices are used to conduct

alcohol screening tests?

40.231 What devices are used to conduct

alcohol confirmation tests?

40.233 What are the requirements for

proper use and care of EBTs?

40.235 What are the requirements for

proper use and care of ASDs?

Subpart L—Alcohol Screening Tests

40.241 What are the first steps in any

alcohol screening test?

40.243 What is the procedure for an alcohol

screening test using an EBT or nonevidential breath ASD?

40.245 What is the procedure for an alcohol

screening test using a saliva ASD?

40.247 What procedures does the BAT or

STT follow after a screening test result?

Subpart M—Alcohol Confirmation Tests

40.251 What are the first steps in an alcohol

confirmation test?

40.253 What are the procedures for

conducting an alcohol confirmation test?

40.255 What happens next after the alcohol

confirmation test result?

Subpart N—Problems in Alcohol Testing

40.261 What is a refusal to take an alcohol

test, and what are the consequences?

40.263 What happens when an employee is

unable to provide a sufficient amount of

saliva for an alcohol screening test?

40.265 What happens when an employee is

unable to provide a sufficient amount of

breath for an alcohol test?

40.267 What problems always cause an

alcohol test to be cancelled?

40.269 What problems cause an alcohol test

to be cancelled unless they are

corrected?

40.271 How are alcohol testing problems

corrected?

40.273 What is the effect of a cancelled

alcohol test?

40.275 What is the effect of procedural

problems that are not sufficient to cancel

an alcohol test?

40.277 Are alcohol tests other than saliva or

breath permitted under these

regulations?

Subpart O—Substance Abuse

Professionals and the Return-to-Duty

Process

40.281 Who is qualified to act as a SAP?

40.283 How does a certification

organization obtain recognition for its

members as SAPs?

40.285 When is a SAP evaluation required?

40.287 What information is an employer

required to provide concerning SAP

services to an employee who has a DOT

drug and alcohol regulation violation?

40.289 Are employers required to provide

SAP and treatment services to

employees?

40.291 What is the role of the SAP in the

evaluation, referral, and treatment

process of an employee who has violated

DOT agency drug and alcohol testing

regulations?

40.293 What is the SAP’s function in

conducting the initial evaluation of an

employee?

40.295 May employees or employers seek a

second SAP evaluation if they disagree

with the first SAP’s recommendations?

40.297 Does anyone have the authority to

change a SAP’s initial evaluation?

40.299 What is the SAP’s role and what are

the limits on a SAP’s discretion in

referring employees for education and

treatment?

40.301 What is the SAP’s function in the

follow-up evaluation of an employee?

40.303 What happens if the SAP believes

the employee needs additional

treatment, aftercare, or support group

services even after the employee returns

to safety-sensitive duties?

40.305 How does the return-to-duty process

conclude?

40.307 What is the SAP’s function in

prescribing the employee’s follow-up

tests?

40.309 What are the employer’s

responsibilities with respect to the SAP’s

directions for follow-up tests?

40.311 What are requirements concerning

SAP reports?

40.313 Where is other information on SAP

functions and the return-to-duty process

found in this regulation?

Subpart P—Confidentiality and Release of

Information

40.321 What is the general confidentiality

rule for drug and alcohol test

information?

40.323 May program participants release

drug or alcohol test information in

connection with legal proceedings?

40.325 [Reserved]

40.327 When must the MRO report medical

information gathered in the verification

process?

40.329 What information must laboratories,

MROs, and other service agents release

to employees?

79528 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

40.331 To what additional parties must

employers and service agents release

information?

40.333 What records must employers keep?

Subpart Q—Roles And Responsibilities of

Service Agents

40.341 Must service agents comply with

DOT drug and alcohol testing

requirements?

40.343 What tasks may a service agent

perform for an employer?

40.345 In what circumstances may a C/TPA

act as an intermediary in the

transmission of drug and alcohol testing

information to employers?

40.347 What functions may C/TPAs

perform with respect administering

testing?

40.349 What records may a service agent

receive and maintain?

40.351 What confidentiality requirements

apply to service agents?

40.353 What principles govern the

interaction between MROs and other

service agents?

40.355 What limitations apply to the

activities of service agents?

Subpart R—Public Interest Exclusions

40.361 What is the purpose of a public

interest exclusion (PIE)?

40.363 On what basis may the Department

issue a PIE?

40.365 What is the Department’s policy

concerning starting a PIE proceeding?

40.367 Who initiates a PIE proceeding?

40.369 What is the discretion of an

initiating official in starting a PIE

proceeding?

40.371 On what information does an

initiating official rely in deciding

whether to start a PIE proceeding?

40.373 Before starting a PIE proceeding,

does the initiating official give the

service agent an opportunity to correct

problems?

40.375 How does the initiating official start

a PIE proceeding?

40.377 Who decides whether to issue a PIE?

40.379 How do you contest the issuance of

a PIE?

40.381 What information do you present to

contest the proposed issuance of a PIE?

40.383 What procedures apply if you

contest the issuance of a PIE?

40.385 Who bears the burden of proof in a

PIE proceeding?

40.387 What matters does the Director

decide concerning a proposed PIE?

40.389 What factors may the Director

consider?

40.391 What is the scope of a PIE?

40.393 How long does a PIE stay in effect?

40.395 Can you settle a PIE proceeding?

40.397 When does the Director make a PIE

decision?

40.399 How does the Department notify

service agents of its decision?

40.401 How does the Department notify

employers and the public about a PIE?

40.403 Must a service agent notify its

clients when the Department issues a

PIE?

40.405 May the Federal courts review PIE

decisions?

40.407 May a service agent ask to have a

PIE reduced or terminated?

40.409 What does the issuance of a PIE

mean to transportation employers?

40.411 What is the role of the DOT

Inspector General’s office?

40.413 How are notices sent to service

agents?

Appendix A to Part 40—DOT Standards for

Urine Collection Kits

Appendix B to Part 40—DOT Drug Testing

Semi-annual Laboratory Report

Appendix C to Part 40—[Reserved]

Appendix D to Part 40—Report Format: Split

Specimen Failure to Reconfirm

Appendix E to Part 40—SAP Equivalency

Requirements for Certification

Organizations

Appendix F to Part 40—Drug and Alcohol

Testing Information that C/TPAs May

Transmit to Employers

Appendix G to Part 40—Alcohol Testing

Form (ATF)

Authority: 49 U.S.C. 102, 301, 322, 5331,

20140, 31306, and 45101 et seq.

Subpart A—Administrative Provisions

§ 40.1 Who does this regulation cover?

(a) This part tells all parties who

conduct drug and alcohol tests required

by Department of Transportation (DOT)

agency regulations how to conduct these

tests and what procedures to use.

(b) This part concerns the activities of

transportation employers, safetysensitive transportation employees

(including self-employed individuals,

contractors and volunteers as covered

by DOT agency regulations), and service

agents.

(c) Nothing in this part is intended to

supersede or conflict with the

implementation of the Federal Railroad

Administration’s post-accident testing

program (see 49 CFR 219.200).

§ 40.3 What do the terms used in this

regulation mean?

In this part, the terms listed in this

section have the following meanings:

Adulterated specimen. A specimen

that contains a substance that is not

expected to be present in human urine,

or contains a substance expected to be

present but is at a concentration so high

that it is not consistent with human

urine.

Affiliate. Persons are affiliates of one

another if, directly or indirectly, one

controls or has the power to control the

other, or a third party controls or has the

power to control both. Indicators of

control include, but are not limited to:

interlocking management or ownership;

shared interest among family members;

shared facilities or equipment; or

common use of employees. Following

the issuance of a public interest

exclusion, an organization having the

same or similar management,

ownership, or principal employees as

the service agent concerning whom a

public interest exclusion is in effect is

regarded as an affiliate. This definition

is used in connection with the public

interest exclusion procedures of Subpart

R of this part.

Air blank. In evidential breath testing

devices (EBTs) using gas

chromatography technology, a reading

of the device’s internal standard. In all

other EBTs, a reading of ambient air

containing no alcohol.

Alcohol. The intoxicating agent in

beverage alcohol, ethyl alcohol or other

low molecular weight alcohols,

including methyl or isopropyl alcohol.

Alcohol concentration. The alcohol in

a volume of breath expressed in terms

of grams of alcohol per 210 liters of

breath as indicated by a breath test

under this part.

Alcohol confirmation test. A

subsequent test using an EBT, following

a screening test with a result of 0.02 or

greater, that provides quantitative data

about the alcohol concentration.

Alcohol screening device (ASD). A

breath or saliva device, other than an

EBT, that is approved by the National

Highway Traffic Safety Administration

(NHTSA) and placed on a conforming

products list (CPL) for such devices.

Alcohol screening test. An analytic

procedure to determine whether an

employee may have a prohibited

concentration of alcohol in a breath or

saliva specimen.

Alcohol testing site. A place selected

by the employer where employees

present themselves for the purpose of

providing breath or saliva for an alcohol

test.

Alcohol use. The drinking or

swallowing of any beverage, liquid

mixture or preparation (including any

medication), containing alcohol.

Blind specimen or blind performance

test specimen. A specimen submitted to

a laboratory for quality control testing

purposes, with a fictitious identifier, so

that the laboratory cannot distinguish it

from an employee specimen.

Breath Alcohol Technician (BAT). A

person who instructs and assists

employees in the alcohol testing process

and operates an evidential breath testing

device.

Cancelled test. A drug or alcohol test

that has a problem identified that

cannot be or has not been corrected, or

which this part otherwise requires to be

cancelled. A cancelled test is neither a

positive nor a negative test.

Chain of custody. The procedure used

to document the handling of the urine

specimen from the time the employee

gives the specimen to the collector until

the specimen is destroyed. This

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79529

procedure uses the Federal Drug Testing

Custody and Control Form (CCF).

Collection container. A container into

which the employee urinates to provide

the specimen for a drug test.

Collection site. A place selected by

the employer where employees present

themselves for the purpose of providing

a urine specimen for a drug test.

Collector. A person who instructs and

assists employees at a collection site,

who receives and makes an initial

inspection of the specimen provided by

those employees, and who initiates and

completes the CCF.

Confirmation (or confirmatory) drug

test. A second analytical procedure

performed on a urine specimen to

identify and quantify the presence of a

specific drug or drug metabolite.

Confirmation (or confirmatory)

validity test. A second test performed on

a urine specimen to further support a

validity test result.

Confirmed drug test. A confirmation

test result received by an MRO from a

laboratory.

Consortium/Third-party administrator

(C/TPA). A service agent that provides

or coordinates the provision of a variety

of drug and alcohol testing services to

employers. C/TPAs typically perform

administrative tasks concerning the

operation of the employers’ drug and

alcohol testing programs. This term

includes, but is not limited to, groups of

employers who join together to

administer, as a single entity, the DOT

drug and alcohol testing programs of its

members. C/TPAs are not ‘‘employers’’

for purposes of this part.

Continuing education. Training for

medical review officers (MROs) and

substance abuse professionals (SAPs)

who have completed qualification

training and are performing MRO or

SAP functions, designed to keep MROs

and SAPs current on changes and

developments in the DOT drug and

alcohol testing program.

Designated employer representative

(DER). An employee authorized by the

employer to take immediate action(s) to

remove employees from safety-sensitive

duties and to make required decisions

in the testing and evaluation processes.

The DER also receives test results and

other communications for the employer,

consistent with the requirements of this

part. Service agents cannot act as DERs.

Dilute specimen. A specimen with

creatinine and specific gravity values

that are lower than expected for human

urine.

DOT, The Department, DOT agency.

These terms encompass all DOT

agencies, including, but not limited to,

the United States Coast Guard (USCG),

the Federal Aviation Administration

(FAA), the Federal Railroad

Administration (FRA), the Federal

Motor Carrier Safety Administration

(FMCSA), the Federal Transit

Administration (FTA), the National

Highway Traffic Safety Administration

(NHTSA), the Research and Special

Programs Administration (RSPA), and

the Office of the Secretary (OST). These

terms include any designee of a DOT

agency.

Drugs. The drugs for which tests are

required under this part and DOT

agency regulations are marijuana,

cocaine, amphetamines, phencyclidine

(PCP), and opiates.

Employee. Any person who is

designated in a DOT agency regulation

as subject to drug testing and/or alcohol

testing. The term includes individuals

currently performing safety-sensitive

functions designated in DOT agency

regulations and applicants for

employment subject to pre-employment

testing. For purposes of drug testing

under this part, the term employee has

the same meaning as the term ‘‘donor’’

as found on CCF and related guidance

materials produced by the Department

of Health and Human Services.

Employer. A person or entity

employing one or more employees

(including an individual who is selfemployed) subject to DOT agency

regulations requiring compliance with

this part. The term includes an

employer’s officers, representatives, and

management personnel. Service agents

are not employers for the purposes of

this part.

Error Correction Training. Training

provided to BATs, collectors, and

screening test technicians (STTs)

following an error that resulted in the

cancellation of a drug or alcohol test.

Error correction training must be

provided in person or by a means that

provides real-time observation and

interaction between the instructor and

trainee.

Evidential Breath Testing Device

(EBT). A device approved by NHTSA for

the evidential testing of breath at the .02

and .04 alcohol concentrations, placed

on NHTSA’s Conforming Products List

(CPL) for ‘‘Evidential Breath

Measurement Devices’’ and identified

on the CPL as conforming with the

model specifications available from

NHTSA’s Traffic Safety Program.

HHS. The Department of Health and

Human Services or any designee of the

Secretary, Department of Health and

Human Services.

Initial drug test. The test used to

differentiate a negative specimen from

one that requires further testing for

drugs or drug metabolites.

Initial validity test. The first test used

to determine if a specimen is

adulterated, diluted, or substituted.

Laboratory. Any U.S. laboratory

certified by HHS under the National

Laboratory Certification Program as

meeting the minimum standards of

Subpart C of the HHS Mandatory

Guidelines for Federal Workplace Drug

Testing Programs; or, in the case of

foreign laboratories, a laboratory

approved for participation by DOT

under this part. (The HHS Mandatory

Guidelines for Federal Workplace Drug

Testing Programs are available on the

internet at http://www.health.org/

workpl.htm or from the Division of

Workplace Programs, 5600 Fishers Lane,

Rockwall II Building, Suite 815,

Rockville, MD 20857.)

Medical Review Officer (MRO). A

person who is a licensed physician and

who is responsible for receiving and

reviewing laboratory results generated

by an employer’s drug testing program

and evaluating medical explanations for

certain drug test results.

Office of Drug and Alcohol Policy and

Compliance (ODAPC). The office in the

Office of the Secretary, DOT, that is

responsible for coordinating drug and

alcohol testing program matters within

the Department and providing

information concerning the

implementation of this part.

Primary specimen. In drug testing, the

urine specimen bottle that is opened

and tested by a first laboratory to

determine whether the employee has a

drug or drug metabolite in his or her

system; and for the purpose of validity

testing. The primary specimen is

distinguished from the split specimen,

defined in this section.

Qualification Training. The training

required in order for a collector, BAT,

MRO, SAP, or STT to be qualified to

perform their functions in the DOT drug

and alcohol testing program.

Qualification training may be provided

by any appropriate means (e.g.,

classroom instruction, internet

application, CD–ROM, video).

Refresher Training. The training

required periodically for qualified

collectors, BATs, and STTs to review

basic requirements and provide

instruction concerning changes in

technology (e.g., new testing methods

that may be authorized) and

amendments, interpretations, guidance,

and issues concerning this part and

DOT agency drug and alcohol testing

regulations. Refresher training can be

provided by any appropriate means

(e.g., classroom instruction, internet

application, CD–ROM, video).

Screening Test Technician (STT). A

person who instructs and assists

79530 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

employees in the alcohol testing process

and operates an ASD.

Secretary. The Secretary of

Transportation or the Secretary’s

designee.

Service agent. Any person or entity,

other than an employee of the employer,

who provides services specified under

this part to employers and/or employees

in connection with DOT drug and

alcohol testing requirements. This

includes, but is not limited to,

collectors, BATs and STTs, laboratories,

MROs, substance abuse professionals,

and C/TPAs. To act as service agents,

persons and organizations must meet

the qualifications set forth in applicable

sections of this part. Service agents are

not employers for purposes of this part.

Shipping container. A container that

is used for transporting and protecting

urine specimen bottles and associated

documents from the collection site to

the laboratory.

Specimen bottle. The bottle that, after

being sealed and labeled according to

the procedures in this part, is used to

hold the urine specimen during

transportation to the laboratory.

Split specimen. In drug testing, a part

of the urine specimen that is sent to a

first laboratory and retained unopened,

and which is transported to a second

laboratory in the event that the

employee requests that it be tested

following a verified positive test of the

primary specimen or a verified

adulterated or substituted test result.

Stand-down. The practice of

temporarily removing an employee from

the performance of safety-sensitive

functions based only on a report from a

laboratory to the MRO of a confirmed

positive test for a drug or drug

metabolite, an adulterated test, or a

substituted test, before the MRO has

completed verification of the test result.

Substance Abuse Professional (SAP).

A person who evaluates employees who

have violated a DOT drug and alcohol

regulation and makes recommendations

concerning education, treatment,

follow-up testing, and aftercare.

Substituted specimen. A specimen

with creatinine and specific gravity

values that are so diminished that they

are not consistent with human urine.

Verified test. A drug test result or

validity testing result from an HHScertified laboratory that has undergone

review and final determination by the

MRO.

§ 40.5 Who issues authoritative

interpretations of this regulation?

ODAPC and the DOT Office of

General Counsel (OGC) provide written

interpretations of the provisions of this

part. These written DOT interpretations

are the only official and authoritative

interpretations concerning the

provisions of this part. DOT agencies

may incorporate ODAPC/OGC

interpretations in written guidance they

issue concerning drug and alcohol

testing matters. Only Part 40

interpretations issued after August 1,

2001, are considered valid.

§ 40.7 How can you get an exemption from

a requirement in this regulation?

(a) If you want an exemption from any

provision of this part, you must request

it in writing from the Office of the

Secretary of Transportation, under the

provisions and standards of 49 CFR part

5. You must send requests for an

exemption to the following address:

Department of Transportation, Deputy

Assistant General Counsel for

Regulation and Enforcement, 400 7th

Street, SW., Room 10424, Washington,

DC 20590.

(b) Under the standards of 49 CFR

part 5, we will grant the request only if

the request documents special or

exceptional circumstances, not likely to

be generally applicable and not

contemplated in connection with the

rulemaking that established this part,

that make your compliance with a

specific provision of this part

impracticable.

(c) If we grant you an exemption, you

must agree to take steps we specify to

comply with the intent of the provision

from which an exemption is granted.

(d) We will issue written responses to

all exemption requests.

Subpart B—Employer Responsibilities

§ 40.11 What are the general

responsibilities of employers under this

regulation?

(a) As an employer, you are

responsible for meeting all applicable

requirements and procedures of this

part.

(b) You are responsible for all actions

of your officials, representatives, and

agents (including service agents) in

carrying out the requirements of the

DOT agency regulations.

(c) All agreements and arrangements,

written or unwritten, between and

among employers and service agents

concerning the implementation of DOT

drug and alcohol testing requirements

are deemed, as a matter of law, to

require compliance with all applicable

provisions of this part and DOT agency

drug and alcohol testing regulations.

Compliance with these provisions is a

material term of all such agreements and

arrangements.

§ 40.13 How do DOT drug and alcohol

tests relate to non-DOT tests?

(a) DOT tests must be completely

separate from non-DOT tests in all

respects.

(b) DOT tests must take priority and

must be conducted and completed

before a non-DOT test is begun. For

example, you must discard any excess

urine left over from a DOT test and

collect a separate void for the

subsequent non-DOT test.

(c) Except as provided in paragraph

(d) of this section, you must not perform

any tests on DOT urine or breath

specimens other than those specifically

authorized by this part or DOT agency

regulations. For example, you may not

test a DOT urine specimen for

additional drugs, and a laboratory is

prohibited from making a DOT urine

specimen available for a DNA test or

other types of specimen identity testing.

(d) The single exception to paragraph

(c) of this section is when a DOT drug

test collection is conducted as part of a

physical examination required by DOT

agency regulations. It is permissible to

conduct required medical tests related

to this physical examination (e.g., for

glucose) on any urine remaining in the

collection container after the drug test

urine specimens have been sealed into

the specimen bottles.

(e) No one is permitted to change or

disregard the results of DOT tests based

on the results of non-DOT tests. For

example, as an employer you must not

disregard a verified positive DOT drug

test result because the employee

presents a negative test result from a

blood or urine specimen collected by

the employee’s physician or a DNA test

result purporting to question the

identity of the DOT specimen.

(f) As an employer, you must not use

the CCF or the ATF in your non-DOT

drug and alcohol testing programs. This

prohibition includes the use of the DOT

forms with references to DOT programs

and agencies crossed out. You also must

always use the CCF and ATF for all your

DOT-mandated drug and alcohol tests.

§ 40.15 May an employer use a service

agent to meet DOT drug and alcohol testing

requirements?

(a) As an employer, you may use a

service agent to perform the tasks

needed to comply with this part and

DOT agency drug and alcohol testing

regulations, consistent with the

requirements of Subpart Q and other

applicable provisions of this part.

(b) As an employer, you are

responsible for ensuring that the service

agents you use meet the qualifications

set forth in this part (e.g., § 40.121 for

MROs). You may require service agents

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79531

to show you documentation that they

meet the requirements of this part (e.g.,

documentation of MRO qualifications

required by § 40.121(e)).

(c) You remain responsible for

compliance with all applicable

requirements of this part and other DOT

drug and alcohol testing regulations,

even when you use a service agent. If

you violate this part or other DOT drug

and alcohol testing regulations because

a service agent has not provided

services as our rules require, a DOT

agency can subject you to sanctions.

Your good faith use of a service agent

is not a defense in an enforcement

action initiated by a DOT agency in

which your alleged noncompliance with

this part or a DOT agency drug and

alcohol regulation may have resulted

from the service agent’s conduct.

(d) As an employer, you must not

permit a service agent to act as your

DER.

§ 40.17 Is an employer responsible for

obtaining information from its service

agents?

Yes, as an employer, you are

responsible for obtaining information

required by this part from your service

agents. This is true whether or not you

choose to use a C/TPA as an

intermediary in transmitting

information to you. For example,

suppose an applicant for a safetysensitive job takes a pre-employment

drug test, but there is a significant delay

in your receipt of the test result from an

MRO or C/TPA. You must not assume

that ‘‘no news is good news’’ and permit

the applicant to perform safety-sensitive

duties before receiving the result. This

is a violation of the Department’s

regulations.

§ 40.19 [Reserved]

§ 40.21 May an employer stand down an

employee before the MRO has completed

the verification process?

(a) As an employer, you are

prohibited from standing employees

down, except consistent with a waiver

a DOT agency grants under this section.

(b) You may make a request to the

concerned DOT agency for a waiver

from the prohibition of paragraph (a) of

this section. Such a waiver, if granted,

permits you to stand an employee down

following the MRO’s receipt of a

laboratory report of a confirmed positive

test for a drug or drug metabolite, an

adulterated test, or a substituted test

pertaining to the employee.

(1) For this purpose, the concerned

DOT agency is the one whose drug and

alcohol testing rules apply to the

majority of the covered employees in

your organization. The concerned DOT

agency uses its applicable procedures

for considering requests for waivers.

(2) Before taking action on a waiver

request, the concerned DOT agency

coordinates with other DOT agencies

that regulate the employer’s other

covered employees.

(3) The concerned DOT agency

provides a written response to each

employer that petitions for a waiver,

setting forth the reasons for the agency’s

decision on the waiver request.

(c) Your request for a waiver must

include, as a minimum, the following

elements:

(1) Information about your

organization:

(i) Your determination that standing

employees down is necessary for safety

in your organization and a statement of

your basis for it, including any data on

safety problems or incidents that could

have been prevented if a stand-down

procedure had been in place;

(ii) Data showing the number of

confirmed laboratory positive,

adulterated, and substituted test results

for your employees over the two

calendar years preceding your waiver

request, and the number and percentage

of those test results that were verified

positive, adulterated, or substituted by

the MRO;

(iii) Information about the work

situation of the employees subject to

stand-down, including a description of

the size and organization of the unit(s)

in which the employees work, the

process through which employees will

be informed of the stand-down, whether

there is an in-house MRO, and whether

your organization has a medical

disqualification or stand-down policy

for employees in situations other than

drug and alcohol testing; and

(iv) A statement of which DOT

agencies regulate your employees.

(2) Your proposed written company

policy concerning stand-down, which

must include the following elements:

(i) Your assurance that you will

distribute copies of your written policy

to all employees that it covers;

(ii) Your means of ensuring that no

information about the confirmed

positive, adulterated, or substituted test

result or the reason for the employee’s

temporary removal from performance of

safety-sensitive functions becomes

available, directly or indirectly, to

anyone in your organization (or

subsequently to another employer) other

than the employee, the MRO and the

DER;

(iii) Your means of ensuring that all

covered employees in a particular job

category in your organization are treated

the same way with respect to standdown;

(iv) Your means of ensuring that a

covered employee will be subject to

stand-down only with respect to the

actual performance of safety-sensitive

duties;

(v) Your means of ensuring that you

will not take any action adversely

affecting the employee’s pay and

benefits pending the completion of the

MRO’s verification process. This

includes continuing to pay the

employee during the period of the

stand-down in the same way you would

have paid him or her had he or she not

been stood down;

(vi) Your means of ensuring that the

verification process will commence no

later than the time an employee is

temporarily removed from the

performance of safety-sensitive

functions and that the period of standdown for any employee will not exceed

five days, unless you are informed in

writing by the MRO that a longer period

is needed to complete the verification

process; and

(vii) Your means of ensuring that, in

the event that the MRO verifies the test

negative or cancels it—

(A) You return the employee

immediately to the performance of

safety-sensitive duties;

(B) The employee suffers no adverse

personnel or financial consequences as

a result; and

(C) You maintain no individually

identifiable record that the employee

had a confirmed laboratory positive,

adulterated, or substituted test result

(i.e., you maintain a record of the test

only as a negative or cancelled test).

(d) The Administrator of the

concerned DOT agency, or his or her

designee, may grant a waiver request

only if he or she determines that, in the

context of your organization, there is a

high probability that the procedures you

propose will effectively enhance safety

and protect the interests of employees in

fairness and confidentiality.

(1) The Administrator, or his or her

designee, may impose any conditions he

or she deems appropriate on the grant

of a waiver.

(2) The Administrator, or his or her

designee, may immediately suspend or

revoke the waiver if he or she

determines that you have failed to

protect effectively the interests of

employees in fairness and

confidentiality, that you have failed to

comply with the requirements of this

section, or that you have failed to

comply with any other conditions the

DOT agency has attached to the waiver.

(e) You must not stand employees

down in the absence of a waiver, or

inconsistent with the terms of your

waiver. If you do, you are in violation

79532 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

of this part and DOT agency drug testing

regulations, and you are subject to

enforcement action by the DOT agency

just as you are for other violations of

this part and DOT agency rules.

§ 40.23 What actions do employers take

after receiving verified test results?

(a) As an employer who receives a

verified positive drug test result, you

must immediately remove the employee

involved from performing safetysensitive functions. You must take this

action upon receiving the initial report

of the verified positive test result. Do

not wait to receive the written report or

the result of a split specimen test.

(b) As an employer who receives a

verified adulterated or substituted drug

test result, you must consider this a

refusal to test and immediately remove

the employee involved from performing

safety-sensitive functions. You must

take this action on receiving the initial

report of the verified adulterated or

substituted test result. Do not wait to

receive the written report or the result

of a split specimen test.

(c) As an employer who receives an

alcohol test result of 0.04 or higher, you

must immediately remove the employee

involved from performing safetysensitive functions. If you receive an

alcohol test result of 0.02—0.39, you

must temporarily remove the employee

involved from performing safetysensitive functions, as provided in

applicable DOT agency regulations. Do

not wait to receive the written report of

the result of the test.

(d) As an employer, when an

employee has a verified positive,

adulterated, or substituted test result, or

has otherwise violated a DOT agency

drug and alcohol regulation, you must

not return the employee to the

performance of safety-sensitive

functions until or unless the employee

successfully completes the return-toduty process of Subpart O of this part.

(e) As an employer who receives a

drug test result indicating that the

employee’s specimen was dilute, take

action as provided in § 40.197.

(f) As an employer who receives a

drug test result indicating that the

employee’s specimen was invalid and

that a second collection must take place

under direct observation—

(1) You must immediately direct the

employee to provide a new specimen

under direct observation.

(2) You must not attach consequences

to the finding that the test was invalid

other than collecting a new specimen

under direct observation.

(3) You must not give any advance

notice of this test requirement to the

employee.

(4) You must instruct the collector to

note on the CCF the same reason (e.g.

random test, post-accident test) as for

the original collection.

(g) As an employer who receives a

cancelled test result when a negative

result is required (e.g., pre-employment,

return-to-duty, or follow-up test), you

must direct the employee to provide

another specimen immediately.

(h) As an employer, you may also be

required to take additional actions

required by DOT agency regulations

(e.g., FAA rules require some positive

drug tests to be reported to the Federal

Air Surgeon).

(i) As an employer, you must not alter

a drug or alcohol test result transmitted

to you by an MRO, BAT, or C/TPA.

§ 40.25 Must an employer check on the

drug and alcohol testing record of

employees it is intending to use to perform

safety-sensitive duties?

(a) Yes, as an employer, you must,

after obtaining an employee’s written

consent, request the information about

the employee listed in paragraph (b) of

this section. This requirement applies

only to employees seeking to begin

performing safety-sensitive duties for

you for the first time (i.e., a new hire,

an employee transfers into a safetysensitive position). If the employee

refuses to provide this written consent,

you must not permit the employee to

perform safety-sensitive functions.

(b) You must request the information

listed in this paragraph (b) from DOTregulated employers who have

employed the employee during any

period during the two years before the

date of the employee’s application or

transfer:

(1) Alcohol tests with a result of 0.04

or higher alcohol concentration;

(2) Verified positive drug tests;

(3) Refusals to be tested (including

verified adulterated or substituted drug

test results);

(4) Other violations of DOT agency

drug and alcohol testing regulations;

and

(5) With respect to any employee who

violated a DOT drug and alcohol

regulation, documentation of the

employee’s successful completion of

DOT return-to-duty requirements

(including follow-up tests). If the

previous employer does not have

information about the return-do-duty

process (e.g., an employer who did not

hire an employee who tested positive on

a pre-employment test), you must seek

to obtain this information from the

employee.

(c) The information obtained from a

previous employer includes any drug or

alcohol test information obtained from

previous employers under this section

or other applicable DOT agency

regulations.

(d) If feasible, you must obtain and

review this information before the

employee first performs safety-sensitive

functions. If this is not feasible, you

must obtain and review the information

as soon as possible. However, you must

not permit the employee to perform

safety-sensitive functions after 30 days

from the date on which the employee

first performed safety-sensitive

functions, unless you have obtained or

made and documented a good faith

effort to obtain this information.

(e) If you obtain information that the

employee has violated a DOT agency

drug and alcohol regulation, you must

not use the employee to perform safetysensitive functions unless you also

obtain information that the employee

has subsequently complied with the

return-to-duty requirements of Subpart

O of this part and DOT agency drug and

alcohol regulations.

(f) You must provide to each of the

employers from whom you request

information under paragraph (b) of this

section written consent for the release of

the information cited in paragraph (a) of

this section.

(g) The release of information under

this section must be in any written form

(e.g., fax, e-mail, letter) that ensures

confidentiality. As the previous

employer, you must maintain a written

record of the information released,

including the date, the party to whom

it was released, and a summary of the

information provided.

(h) If you are an employer from whom

information is requested under

paragraph (b) of this section, you must,

after reviewing the employee’s specific,

written consent, immediately release the

requested information to the employer

making the inquiry.

(i) As the employer requesting the

information required under this section,

you must maintain a written,

confidential record of the information

you obtain or of the good faith efforts

you made to obtain the information.

You must retain this information for

three years from the date of the

employee’s first performance of safetysensitive duties for you.

(j) As the employer, you must also ask

the employee whether he or she has

tested positive, or refused to test, on any

pre-employment drug or alcohol test

administered by an employer to which

the employee applied for, but did not

obtain, safety-sensitive transportation

work covered by DOT agency drug and

alcohol testing rules during the past two

years. If the employee admits that he or

she had a positive test or a refusal to

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79533

test, you must not use the employee to

perform safety-sensitive functions for

you, until and unless the employee

documents successful completion of the

return-to-duty process (see paragraphs

(b)(5) and (e) of this section).

§ 40.27 Where is other information on

employer responsibilities found in this

regulation?

You can find other information on the

responsibilities of employers in the

following sections of this part:

§ 40.3—Definition.

§ 40.35—Information about DERs that

employers must provide collectors.

§ 40.45—Modifying CCFs, Use of foreignlanguage CCFs.

§ 40.47—Use of non-Federal forms for DOT

tests or Federal CCFs for non-DOT tests.

§ 40.67—Requirements for direct observation.

§§ 40.103–40.105—Blind specimen

requirements.

§ 40. 173—Responsibility to ensure test of

split specimen.

§ 40.193—Action in ‘‘shy bladder’’ situations.

§ 40.197—Actions following report of a dilute

specimen.

§ 40.207—Actions following a report of a

cancelled drug test.

§ 40.209—Actions following and

consequences of non-fatal flaws in drug

tests.

§ 40.215—Information about DERs that

employers must provide BATs and STTs.

§ 40.225—Modifying ATFs; use of foreignlanguage ATFs.

§ 40.227—Use of non-DOT forms for DOT

tests or DOT ATFs for non-DOT tests.

§ 40.235 (c) and (d)—responsibility to follow

instructions for ASDs.

§ 40.255 (b)—receipt and storage of alcohol

test information.

§ 40.265 (c)–(e)—actions in ‘‘shy lung’’

situations.

§ 40.267—Cancellation of alcohol tests.

§ 40.271—Actions in ‘‘correctable flaw’’

situations in alcohol tests.

§ 40.273—Actions following cancelled tests

in alcohol tests.

§ 40.275—Actions in ‘‘non-fatal flaw’’

situations in alcohol tests.

§§ 40.287–40.289—Responsibilities

concerning SAP services.

§§ 40.295–40.297—Prohibition on seeking

second SAP evaluation or changing SAP

recommendation.

§ 40.303—Responsibilities concerning

aftercare recommendations.

§ 40.305—Responsibilities concerning returnto-duty decision.

§ 40.309—Responsibilities concerning

follow-up tests.

§ 40.321—General confidentiality

requirement.

§ 40.323—Release of confidential information

in litigation.

§ 40.331—Other circumstances for the release

of confidential information.

§ 40.333—Record retention requirements.

§ 40.345—Choice of who reports drug testing

information to employers.

Subpart C—Urine Collection Personnel

§ 40.31 Who may collect urine specimens

for DOT drug testing?

(a) Collectors meeting the

requirements of this subpart are the only

persons authorized to collect urine

specimens for DOT drug testing.

(b) A collector must meet training

requirements of § 40.33.

(c) As the immediate supervisor of an

employee being tested, you may not act

as the collector when that employee is

tested, unless no other collector is

available and you are permitted to do so

under DOT agency drug and alcohol

regulations.

(d) You must not act as the collector

for the employee being tested if you

work for a HHS-certified laboratory (e.g.,

as a technician or accessioner) and

could link the employee with a urine

specimen, drug testing result, or

laboratory report.

§ 40.33 What training requirements must a

collector meet?

To be permitted to act as a collector

in the DOT drug testing program, you

must meet each of the requirements of

this section:

(a) Basic information. You must be

knowledgeable about this part, the

current ‘‘DOT Urine Specimen

Collection Procedures Guidelines,’’ and

DOT agency regulations applicable to

the employers for whom you perform

collections, and you must keep current

on any changes to these materials. The

DOT Urine Specimen Collection

Procedures Guidelines document is

available from ODAPC (Department of

Transportation, 400 7th Street, SW.,

Room 10403, Washington DC, 20590,

202–366–3784, or on the ODAPC web

site (http://www.dot.gov/ost/dapc).

(b) Qualification training. You must

receive qualification training meeting

the requirements of this paragraph.

Qualification training must provide

instruction on the following subjects:

(1) All steps necessary to complete a

collection correctly and the proper

completion and transmission of the

CCF;

(2) ‘‘Problem’’ collections (e.g.,

situations like ‘‘shy bladder’’ and

attempts to tamper with a specimen);

(3) Fatal flaws, correctable flaws, and

how to correct problems in collections;

and

(4) The collector’s responsibility for

maintaining the integrity of the

collection process, ensuring the privacy

of employees being tested, ensuring the

security of the specimen, and avoiding

conduct or statements that could be

viewed as offensive or inappropriate;

(c) Initial Proficiency Demonstration.

Following your completion of

qualification training under paragraph

(b) of this section, you must

demonstrate proficiency in collections

under this part by completing five

consecutive error-free mock collections.

(1) The five mock collections must

include two uneventful collection

scenarios, one insufficient quantity of

urine scenario, one temperature out of

range scenario, and one scenario in

which the employee refuses to sign the

CCF and initial the specimen bottle

tamper-evident seal.

(2) Another person must monitor and

evaluate your performance, in person or

by a means that provides real-time

observation and interaction between the

instructor and trainee, and attest in

writing that the mock collections are

‘‘error-free.’’ This person must be an

individual who has demonstrated

necessary knowledge, skills, and

abilities by—

(i) Regularly conducting DOT drug

test collections for a period of at least

a year;

(ii) Conducting collector training

under this part for a year; or

(iii) Successfully completing a ‘‘train

the trainer’’ course.

(d) Schedule for qualification training

and initial proficiency demonstration.

The following is the schedule for

qualification training and the initial

proficiency demonstration you must

meet:

(1) If you became a collector before

August 1, 2001, and you have already

met the requirements of paragraphs (b)

and (c) of this section, you do not have

to meet them again.

(2) If you became a collector before

August 1, 2001, and have yet to meet the

requirements of paragraphs (b) and (c) of

this section, you must do so no later

than January 31, 2003.

(3) If you become a collector on or

after August 1, 2001, you must meet the

requirements of paragraphs (b) and (c) of

this section before you begin to perform

collector functions.

(e) Refresher training. No less

frequently than every five years from the

date on which you satisfactorily

complete the requirements of

paragraphs (b) and (c) of this section,

you must complete refresher training

that meets all the requirements of

paragraphs (b) and (c) of this section.

(f) Error Correction Training. If you

make a mistake in the collection process

that causes a test to be cancelled (i.e., a

fatal or uncorrected flaw), you must

undergo error correction training. This

training must occur within 30 days of

the date you are notified of the error that

led to the need for retraining.

(i) Error correction training must be

provided and your proficiency

79534 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

documented in writing by a person who

meets the requirements of paragraph

(c)(2) of this section.

(ii) Error correction training is

required to cover only the subject matter

area(s) in which the error that caused

the test to be cancelled occurred.

(iii) As part of the error correction

training, you must demonstrate your

proficiency in the collection procedures

of this part by completing three

consecutive error-free mock collections.

The mock collections must include one

uneventful scenario and two scenarios

related to the area(s) in which your

error(s) occurred. The person providing

the training must monitor and evaluate

your performance and attest in writing

that the mock collections were ‘‘errorfree.’’

(g) Documentation. You must

maintain documentation showing that

you currently meet all requirements of

this section. You must provide this

documentation on request to DOT

agency representatives and to employers

and C/TPAs who are using or

negotiating to use your services.

§ 40.35 What information about the DER

must employers provide to collectors?

As an employer, you must provide to

collectors the name and telephone

number of the appropriate DER (and C/

TPA, where applicable) to contact about

any problems or issues that may arise

during the testing process.

§ 40.37 Where is other information on the

role of collectors found in this regulation?

You can find other information on the

role and functions of collectors in the

following sections of this part:

§ 40.3—Definition.

§ 40.43—Steps to prepare and secure

collection sites.

§§ 40.45–40.47—Use of CCF.

§§ 40.49–40.51—Use of collection kit and

shipping materials.

§§ 40.61–40.63—Preliminary steps in

collections.

§ 40.65—Role in checking specimens.

§ 40.67—Role in directly observed

collections.

§ 40.69—Role in monitored collections.

§ 40.71—Role in split specimen collections.

§ 40.73—Chain of custody completion and

finishing the collection process.

§ 40.103—Processing blind specimens.

§ 40.191—Action in case of refusals to take

test.

§ 40.193—Action in ‘‘shy bladder’’ situations.

§ 40.199–40.205—Collector errors in tests,

effects, and means of correction.

Subpart D—Collection Sites, Forms,

Equipment and Supplies Used in DOT

Urine Collections

§ 40.41 Where does a urine collection for

a DOT drug test take place?

(a) A urine collection for a DOT drug

test must take place in a collection site

meeting the requirements of this

section.

(b) If you are operating a collection

site, you must ensure that it meets the

security requirements of § 40.43.

(c) If you are operating a collection

site, you must have all necessary

personnel, materials, equipment,

facilities and supervision to provide for

the collection, temporary storage, and

shipping of urine specimens to a

laboratory, and a suitable clean surface

for writing.

(d) Your collection site must include

a facility for urination described in

either paragraph (e) or paragraph (f) of

this section.

(e) The first, and preferred, type of

facility for urination that a collection

site may include is a single-toilet room,

having a full-length privacy door,

within which urination can occur.

(1) No one but the employee may be

present in the room during the

collection, except for the observer in the

event of a directly observed collection.

(2) You must have a source of water

for washing hands, that, if practicable,

should be external to the closed room

where urination occurs. If an external

source is not available, you may meet

this requirement by securing all sources

of water and other substances that could

be used for adulteration and

substitution (e.g., water faucets, soap

dispensers) and providing moist

towelettes outside the closed room.

(f) The second type of facility for

urination that a collection site may

include is a multistall restroom.

(1) Such a site must provide

substantial visual privacy (e.g., a toilet

stall with a partial-length door) and

meet all other applicable requirements

of this section.

(2) If you use a multi-stall restroom,

you must either—

(i) Secure all sources of water and

other substances that could be used for

adulteration and substitution (e.g., water

faucets, soap dispensers) and place

bluing agent in all toilets or secure the

toilets to prevent access; or

(ii) Conduct all collections in the

facility as monitored collections (see

§ 40.69 for procedures). This is the only

circumstance in which you may

conduct a monitored collection.

(3) No one but the employee may be

present in the multistall restroom

during the collection, except for the

monitor in the event of a monitored

collection or the observer in the event

of a directly observed collection.

(g) A collection site may be in a

medical facility, a mobile facility (e.g.,

a van), a dedicated collection facility, or

any other location meeting the

requirements of this section.

§ 40.43 What steps must operators of

collection sites take to protect the security

and integrity of urine collections?

(a) Collectors and operators of

collection sites must take the steps

listed in this section to prevent

unauthorized access that could

compromise the integrity of collections.

(b) As a collector, you must do the

following before each collection to deter

tampering with specimens:

(1) Secure any water sources or

otherwise make them unavailable to

employees (e.g., turn off water inlet,

tape handles to prevent opening

faucets);

(2) Ensure that the water in the toilet

is blue;

(3) Ensure that no soap, disinfectants,

cleaning agents, or other possible

adulterants are present;

(4) Inspect the site to ensure that no

foreign or unauthorized substances are

present;

(5) Tape or otherwise secure shut any

movable toilet tank top, or put bluing in

the tank;

(6) Ensure that undetected access

(e.g., through a door not in your view)

is not possible;

(7) Secure areas and items (e.g.,

ledges, trash receptacles, paper towel

holders, under-sink areas) that appear

suitable for concealing contaminants;

and

(8) Recheck items in paragraphs (b)(1)

through (7) of this section following

each collection to ensure the site’s

continued integrity.

(c) If the collection site uses a facility

normally used for other purposes, like a

public rest room or hospital examining

room, you must, as a collector, also

ensure before the collection that:

(1) Access to collection materials and

specimens is effectively restricted; and

(2) The facility is secured against

access during the procedure to ensure

privacy to the employee and prevent

distraction of the collector. Limitedaccess signs must be posted.

(d) As a collector, you must take the

following additional steps to ensure

security during the collection process:

(1) To avoid distraction that could

compromise security, you are limited to

conducting a collection for only one

employee at a time. However, during the

time one employee is in the period for

drinking fluids in a ‘‘shy bladder’’

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79535

situation (see § 40.193(b)), you may

conduct a collection for another

employee.

(2) To the greatest extent you can,

keep an employee’s collection container

within view of both you and the

employee between the time the

employee has urinated and the

specimen is sealed.

(3) Ensure you are the only person in

addition to the employee who handles

the specimen before it is poured into the

bottles and sealed with tamper-evident

seals.

(4) In the time between when the

employee gives you the specimen and

when you seal the specimen, remain

within the collection site.

(5) Maintain personal control over

each specimen and CCF throughout the

collection process.

(e) If you are operating a collection

site, you must implement a policy and

procedures to prevent unauthorized

personnel from entering any part of the

site in which urine specimens are

collected or stored.

(1) Only employees being tested,

collectors and other collection site

workers, DERs, employee and employer

representatives authorized by the

employer (e.g., employer policy,

collective bargaining agreement), and

DOT agency representatives are

authorized persons for purposes of this

paragraph (e).

(2) Except for the observer in a

directly observed collection or the

monitor in the case of a monitored

collection, you must not permit anyone

to enter the urination facility in which

employees provide specimens.

(3) You must ensure that all

authorized persons are under the

supervision of a collector at all times

when permitted into the site.

(4) You or the collector may remove

any person who obstructs, interferes

with, or causes a delay in the collection

process.

(f) If you are operating a collection

site, you must minimize the number of

persons handling specimens.

§ 40.45 What form is used to document a

DOT urine collection?

(a) The Federal Drug Testing Custody

and Control Form (CCF) must be used

to document every urine collection

required by the DOT drug testing

program. The CCF must be a five-part

carbonless manifold form. You may

view this form on the Department’s web

site (http://www.dot.gov/ost/dapc) or

the HHS web site (http://

www.health.org/workpl.htm).

(b) As a participant in the DOT drug

testing program, you are not permitted

to modify or revise the CCF except as

follows:

(1) You may include, in the area

outside the border of the form, other

information needed for billing or other

purposes necessary to the collection

process.

(2) The CCF must include the names,

addresses, telephone numbers and fax

numbers of the employer and the MRO,

which may be preprinted, typed, or

handwritten. The MRO information

must include the specific physician’s

name and address, as opposed to only

a generic clinic, health care

organization, or company name. This

information is required, and it is

prohibited for an employer, collector,

service agent or any other party to omit

it. In addition, a C/TPA’s name, address,

fax number, and telephone number may

be included, but is not required.

(3) As an employer, you may add the

name of the DOT agency under whose

authority the test occurred as part of the

employer information.

(4) As a collector, you may use a CCF

with your name, address, telephone

number, and fax number preprinted, but

under no circumstances may you sign

the form before the collection event.

(c) Under no circumstances may the

CCF transmit personal identifying

information about an employee (other

than a social security number (SSN) or

other employee identification (ID)

number) to a laboratory.

(d) As an employer, you may use an

equivalent foreign-language version of

the CCF approved by ODAPC. You may

use such a non-English language form

only in a situation where both the

employee and collector understand and

can use the form in that language.

§ 40.47 May employers use the CCF for

non-DOT collections or non-Federal forms

for DOT collections?

(a) No, as an employer, you are

prohibited from using the CCF for nonDOT urine collections. You are also

prohibited from using non-Federal

forms for DOT urine collections. Doing

either subjects you to enforcement

action under DOT agency regulations.

(b) (1) In the rare case where the

collector, either by mistake or as the

only means to conduct a test under

difficult circumstances (e.g., postaccident or reasonable suspicion test

with insufficient time to obtain the

CCF), uses a non-Federal form for a DOT

collection, the use of a non-Federal form

does not present a reason for the

laboratory to reject the specimen for

testing or for an MRO to cancel the

result.

(2) The use of the non-DOT form is a

‘‘correctable flaw.’’ As an MRO, to

correct the problem you must follow the

procedures of § 40.205(b)(2).

§ 40.49 What materials are used to collect

urine specimens?

For each DOT drug test, you must use

a collection kit meeting the

requirements of Appendix A of this

part.

§ 40.51 What materials are used to send

urine specimens to the laboratory?

(a) Except as provided in paragraph

(b) of this section, you must use a

shipping container that adequately

protects the specimen bottles from

shipment damage in the transport of

specimens from the collection site to the

laboratory.

(b) You are not required to use a

shipping container if a laboratory

courier hand-delivers the specimens

from the collection site to the

laboratory.

Subpart E—Urine Specimen

Collections

§ 40.61 What are the preliminary steps in

the collection process?

As the collector, you must take the

following steps before actually

beginning a collection:

(a) When a specific time for an

employee’s test has been scheduled, or

the collection site is at the employee’s

work site, and the employee does not

appear at the collection site at the

scheduled time, contact the DER to

determine the appropriate interval

within which the DER has determined

the employee is authorized to arrive. If

the employee’s arrival is delayed

beyond that time, you must notify the

DER that the employee has not reported

for testing. In a situation where a C/TPA

has notified an owner/operator or other

individual employee to report for testing

and the employee does not appear, the

C/TPA must notify the employee that he

or she has refused to test (see

§ 40.191(a)(1)).

(b) Ensure that, when the employee

enters the collection site, you begin the

testing process without undue delay.

For example, you must not wait because

the employee says he or she is not ready

or is unable to urinate or because an

authorized employer or employee

representative is delayed in arriving.

(1) If the employee is also going to

take a DOT alcohol test, you must, to the

greatest extent practicable, ensure that

the alcohol test is completed before the

urine collection process begins.

Example to Paragraph (b)(1): An employee

enters the test site for both a drug and an

alcohol test. Normally, the collector would

wait until the BAT had completed the

alcohol test process before beginning the

drug test process. However, there are some

situations in which an exception to this

normal practice would be reasonable. One

79536 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

such situation might be if several people

were waiting for the BAT to conduct alcohol

tests, but a drug testing collector in the same

facility were free. Someone waiting might be

able to complete a drug test without unduly

delaying his or her alcohol test. Collectors

and BATs should work together, however, to

ensure that post-accident and reasonable

suspicion alcohol tests happen as soon as

possible (e.g., by moving the employee to the

head of the line for alcohol tests).

(2) If the employee needs medical

attention (e.g., an injured employee in

an emergency medical facility who is

required to have a post-accident test), do

not delay this treatment to collect a

specimen.

(3) You must not collect, by

catheterization or other means, urine

from an unconscious employee to

conduct a drug test under this part. Nor

may you catheterize a conscious

employee. However, you must inform

an employee who normally voids

through self-catheterization that the

employee is required to provide a

specimen in that manner.

(4) If, as an employee, you normally

void through self-catheterization, and

decline to do so, this constitutes a

refusal to test.

(c) Require the employee to provide

positive identification. You must see a

photo ID issued by the employer (other

than in the case of an owner-operator or

other self-employed individual) or a

Federal, state, or local government (e.g.,

a driver’s license). You may not accept

faxes or photocopies of identification.

Positive identification by an employer

representative (not a co-worker or

another employee being tested) is also

acceptable. If the employee cannot

produce positive identification, you

must contact a DER to verify the identity

of the employee.

(d) If the employee asks, provide your

identification to the employee. Your

identification must include your name

and your employer’s name, but does not

have to include your picture, address, or

telephone number.

(e) Explain the basic collection

procedure to the employee, including

showing the employee the instructions

on the back of the CCF.

(f) Direct the employee to remove

outer clothing (e.g., coveralls, jacket,

coat, hat) that could be used to conceal

items or substances that could be used

to tamper with a specimen. You must

also direct the employee to leave these

garments and any briefcase, purse, or

other personal belongings with you or in

a mutually agreeable location. You must

advise the employee that failure to

comply with your directions constitutes

a refusal to test.

(1) If the employee asks for a receipt

for any belongings left with you, you

must provide one.

(2) You must allow the employee to

keep his or her wallet.

(3) You must not ask the employee to

remove other clothing (e.g., shirts,

pants, dresses, underwear), to remove

all clothing, or to change into a hospital

or examination gown (unless the urine

collection is being accomplished

simultaneously with a DOT agencyauthorized medical examination).

(4) You must direct the employee to

empty his or her pockets and display

the items in them to ensure that no

items are present which could be used

to adulterate the specimen. If nothing is

there that can be used to adulterate a

specimen, the employee can place the

items back into his or her pockets. As

the employee, you must allow the

collector to make this observation.

(5) If, in your duties under paragraph

(f)(4) of this section, you find any

material that could be used to tamper

with a specimen, you must:

(i) Determine if the material appears

to be brought to the collection site with

the intent to alter the specimen, and, if

it is, conduct a directly observed

collection using direct observation

procedures (see § 40.67); or

(ii) Determine if the material appears

to be inadvertently brought to the

collection site (e.g., eye drops), secure

and maintain it until the collection

process is completed and conduct a

normal (i.e., unobserved) collection.

(g) You must instruct the employee

not to list medications that he or she is

currently taking on the CCF. (The

employee may make notes of

medications on the back of the

employee copy of the form for his or her

own convenience, but these notes must

not be transmitted to anyone else.)

§ 40.63 What steps does the collector take

in the collection process before the

employee provides a urine specimen?

As the collector, you must take the

following steps before the employee

provides the urine specimen:

(a) Complete Step 1 of the CCF.

(b) Instruct the employee to wash and

dry his or her hands at this time. You

must tell the employee not to wash his

or her hands again until after delivering

the specimen to you. You must not give

the employee any further access to

water or other materials that could be

used to adulterate or dilute a specimen.

(c) Select, or allow the employee to

select, an individually wrapped or

sealed collection container from

collection kit materials. Either you or

the employee, with both of you present,

must unwrap or break the seal of the

collection container. You must not

unwrap or break the seal on any

specimen bottle at this time. You must

not allow the employee to take anything

from the collection kit into the room

used for urination except the collection

container.

(d) Direct the employee to go into the

room used for urination, provide a

specimen of at least 45 mL, not flush the

toilet, and return to you with the

specimen as soon as the employee has

completed the void.

(1) Except in the case of an observed

or a monitored collection (see §§ 40.67

and 40.69 ), neither you nor anyone else

may go into the room with the

employee.

(2) As the collector, you may set a

reasonable time limit for voiding.

(e) You must pay careful attention to

the employee during the entire

collection process to note any conduct

that clearly indicates an attempt to

tamper with a specimen (e.g., substitute

urine in plain view or an attempt to

bring into the collection site an

adulterant or urine substitute). If you

detect such conduct, you must require

that a collection take place immediately

under direct observation (see § 40.67 )

and note the conduct and the fact that

the collection was observed in the

‘‘Remarks’’ line of the CCF (Step 2). You

must also, as soon as possible, inform

the DER and collection site supervisor

that a collection took place under direct

observation and the reason for doing so.

§ 40.65 What does the collector check for

when the employee presents a specimen?

As a collector, you must check the

following when the employee gives the

collection container to you:

(a) Sufficiency of specimen. You must

check to ensure that the specimen

contains at least 45 mL of urine.

(1) If it does not, you must follow

‘‘shy bladder’’ procedures (see

§ 40.193(b)).

(2) When you follow ‘‘shy bladder’’

procedures, you must discard the

original specimen, unless another

problem (i.e., temperature out of range,

signs of tampering) also exists.

(3) You are never permitted to

combine urine collected from separate

voids to create a specimen.

(4) You must discard any excess

urine.

(b) Temperature. You must check the

temperature of the specimen no later

than four minutes after the employee

has given you the specimen.

(1) The acceptable temperature range

is 32–38 °C/90–100 °F.

(2) You must determine the

temperature of the specimen by reading

the temperature strip attached to the

collection container.

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79537

(3) If the specimen temperature is

within the acceptable range, you must

mark the ‘‘Yes’’ box on the CCF (Step 2).

(4) If the specimen temperature is

outside the acceptable range, you must

mark the ‘‘No’’ box and enter in the

‘‘Remarks’’ line (Step 2) your findings

about the temperature.

(5) If the specimen temperature is

outside the acceptable range, you must

immediately conduct a new collection

using direct observation procedures (see

§ 40.67).

(6) In a case where a specimen is

collected under direct observation

because of the temperature being out of

range, you must process both the

original specimen and the specimen

collected using direct observation and

send the two sets of specimens to the

laboratory. This is true even in a case in

which the original specimen has

insufficient volume but the temperature

is out of range. You must also, as soon

as possible, inform the DER and

collection site supervisor that a

collection took place under direct

observation and the reason for doing so.

(7) In a case where the employee

refuses to provide another specimen

(see § 40.191(a)(3)) or refuses to provide

another specimen under direct

observation (see § 40.191(a)(4)), you

must notify the DER. As soon as you

have notified the DER, you must discard

any specimen the employee has

provided previously during the

collection procedure.

(c) Signs of tampering. You must

inspect the specimen for unusual color,

presence of foreign objects or material,

or other signs of tampering (e.g., if you

notice any unusual odor).

(1) If it is apparent from this

inspection that the employee has

tampered with the specimen (e.g., blue

dye in the specimen, excessive foaming

when shaken, smell of bleach), you

must immediately conduct a new

collection using direct observation

procedures (see § 40.67 ).

(2) In a case where a specimen is

collected under direct observation

because of showing signs of tampering,

you must process both the original

specimen and the specimen collected

using direct observation and send the

two sets of specimens to the laboratory.

This is true even in a case in which the

original specimen has insufficient

volume but it shows signs of tampering.

You must also, as soon as possible,

inform the DER and collection site

supervisor that a collection took place

under direct observation and the reason

for doing so.

(3) In a case where the employee

refuses to provide another specimen

(see § 40.191(a)(3)) or refuses to provide

a specimen under direct observation

(see § 40.193(a)(4)), you must notify the

DER. As soon as you have notified the

DER, you must discard any specimen

the employee has provided previously

during the collection procedure.

§ 40.67 When and how is a directly

observed collection conducted?

(a) As an employer you must direct an

immediate collection under direct

observation with no advance notice to

the employee, if:

(1) The laboratory reported to the

MRO that a specimen is invalid, and the

MRO reported to you that there was not

an adequate medical explanation for the

result; or

(2) The MRO reported to you that the

original positive, adulterated, or

substituted test result had to be

cancelled because the test of the split

specimen could not be performed.

(b) As an employer, you may direct a

collection under direct observation of an

employee if the drug test is a return-toduty test or a follow-up test.

(c) As a collector, you must

immediately conduct a collection under

direct observation if:

(1) You are directed by the DER to do

so (see paragraphs (a) and (c) of this

section); or

(2) You observed materials brought to

the collection site or the employee’s

conduct clearly indicates an attempt to

tamper with a specimen (see

§§ 40.61(f)(5)(i) and 40.63(e)); or

(3) The temperature on the original

specimen was out of range (see

§ 40.65(b)(5)); or (4) The original

specimen appeared to have been

tampered with (see § 40.65(c)(1)).

(d)(1) As the employer, you must

explain to the employee the reason for

a directly observed collection under

paragraph (a) or (b) of this section.

(2) As the collector, you must explain

to the employee the reason under this

part for a directly observed collection

under paragraphs (c)(2) through (4) of

this section.

(e) As the collector, you must

complete a new CCF for the directly

observed collection.

(1) You must mark the ‘‘reason for

test’’ block (Step 1) the same as for the

first collection.

(2) You must check the ‘‘Observed,

(Enter Remark)’’ box and enter the

reason (see § 40.67(b)) in the ‘‘Remarks’’

line (Step 2).

(f) In a case where two sets of

specimens are being sent to the

laboratory because of suspected

tampering with the specimen at the

collection site, enter on the ‘‘Remarks’’

line of the CCF (Step 2) for each

specimen a notation to this effect (e.g.,

collection 1 of 2, or 2 of 2) and the

specimen ID number of the other

specimen.

(g) As the collector, you must ensure

that the observer is the same gender as

the employee. You must never permit

an opposite gender person to act as the

observer. The observer can be a different

person from the collector and need not

be a qualified collector.

(h) As the collector, if someone else

is to observe the collection (e.g., in order

to ensure a same gender observer), you

must verbally instruct that person to

follow procedures at paragraphs (i) and

(j) of this section. If you, the collector,

are the observer, you too must follow

these procedures.

(i) As the observer, you must watch

the employee urinate into the collection

container. Specifically, you are to watch

the urine go from the employee’s body

into the collection container.

(j) As the observer but not the

collector, you must not take the

collection container from the employee,

but you must observe the specimen as

the employee takes it to the collector.

(k) As the collector, when someone

else has acted as the observer, you must

include the observer’s name in the

‘‘Remarks’’ line of the CCF (Step 2).

(l) As the employee, if you decline to

allow a directly observed collection

required or permitted under this section

to occur, this is a refusal to test.

§ 40.69 How is a monitored collection

conducted?

(a) As the collector, you must secure

the room being used for the monitored

collection so that no one except the

employee and the monitor can enter it

until after the collection has been

completed.

(b) As the collector, you must ensure

that the monitor is the same gender as

the employee, unless the monitor is a

medical professional (e.g., nurse, doctor,

physician’s assistant). The monitor can

be a different person from the collector

and need not be a qualified collector.

(c) As the collector, if someone else is

to monitor the collection (e.g., in order

to ensure a same gender monitor), you

must verbally instruct that person to

follow procedures at paragraphs (d) and

(e) of this section. If you, the collector,

are the observer, you too must follow

these procedures.

(d) As the monitor, you must not

watch the employee urinate into the

collection container. If you hear sounds

or make other observations indicating

an attempt to tamper with a specimen,

there must be an additional collection

under direct observation (see

§§ 40.63(e), 40.65(c), and 40.67(b)).

79538 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

(e) As the monitor, you must ensure

that the employee takes the collection

container directly to the collector as

soon as the employee has exited the

enclosure.

(f) As the collector, when someone

else has acted as the monitor, you must

note that person’s name in the

‘‘Remarks’’ line of the CCF (Step 2).

(g) As the employee being tested, if

you decline to permit a collection

authorized under this section to be

monitored, it is a refusal to test.

§ 40.71 How does the collector prepare the

specimens?

(a) All collections under DOT agency

drug testing regulations must be split

specimen collections.

(b) As the collector, you must take the

following steps, in order, after the

employee brings the urine specimen to

you. You must take these steps in the

presence of the employee.

(1) Check the box on the CCF (Step 2)

indicating that this was a split specimen

collection.

(2) You, not the employee, must first

pour at least 30 mL of urine from the

collection container into one specimen

bottle, to be used for the primary

specimen.

(3) You, not the employee, must then

pour at least 15 mL of urine from the

collection container into the second

specimen bottle to be used for the split

specimen.

(4) You, not the employee, must place

and secure (i.e., tighten or snap) the

lids/caps on the bottles.

(5) You, not the employee, must seal

the bottles by placing the tamperevident bottle seals over the bottle caps/

lids and down the sides of the bottles.

(6) You, not the employee, must then

write the date on the tamper-evident

bottle seals.

(7) You must then ensure that the

employee initials the tamper-evident

bottle seals for the purpose of certifying

that the bottles contain the specimens

he or she provided. If the employee fails

or refuses to do so, you must note this

in the ‘‘Remarks’’ line of the CCF (Step

2) and complete the collection process.

§ 40.73 How is the collection process

completed?

(a) As the collector, you must do the

following things to complete the

collection process. You must complete

the steps called for in paragraphs (a)(1)

through (a)(7) of this section in the

employee’s presence.

(1) Direct the employee to read and

sign the certification statement on Copy

2 (Step 5) of the CCF and provide date

of birth, printed name, and day and

evening contact telephone numbers. If

the employee refuses to sign the CCF or

to provide date of birth, printed name,

or telephone numbers, you must note

this in the ‘‘Remarks’’ line (Step 2) of

the CCF, and complete the collection. If

the employee refuses to fill out any

information, you must, as a minimum,

print the employee’s name in the

appropriate place.

(2) Complete the chain of custody on

the CCF (Step 5) by printing your name

(note: you may pre-print your name),

recording the time and date of the

collection, signing the statement, and

entering the name of the delivery

service transferring the specimen to the

laboratory,

(3) Ensure that all copies of the CCF

are legible and complete.

(4) Remove Copy 5 of the CCF and

give it to the employee.

(5) Place the specimen bottles and

Copy 1 of the CCF in the appropriate

pouches of the plastic bag.

(6) Secure both pouches of the plastic

bag.

(7) Advise the employee that he or she

may leave the collection site.

(8) To prepare the sealed plastic bag

containing the specimens and CCF for

shipment you must:

(i) Place the sealed plastic bag in a

shipping container (e.g., standard

courier box) designed to minimize the

possibility of damage during shipment.

(More than one sealed plastic bag can be

placed into a single shipping container

if you are doing multiple collections.)

(ii) Seal the container as appropriate.

(iii) If a laboratory courier handdelivers the specimens from the

collection site to the laboratory, prepare

the sealed plastic bag for shipment as

directed by the courier service.

(9) Send Copy 2 of the CCF to the

MRO and Copy 4 to the DER. You must

fax or otherwise transmit these copies to

the MRO and DER within 24 hours or

during the next business day. Keep

Copy 3 for at least 30 days, unless

otherwise specified by applicable DOT

agency regulations.

(b) As a collector or collection site,

you must ensure that each specimen

you collect is shipped to a laboratory as

quickly as possible, but in any case

within 24 hours or during the next

business day.

Subpart F—Drug Testing Laboratories

§ 40.81 What laboratories may be used for

DOT drug testing?

(a) As a drug testing laboratory

located in the U.S., you are permitted to

participate in DOT drug testing only if

you are certified by HHS under the

National Laboratory Certification

Program (NLCP) for all testing required

under this part.

(b) As a drug testing laboratory

located in Canada or Mexico which is

not certified by HHS under the NLCP,

you are permitted to participate in DOT

drug testing only if:

(1) The DOT, based on a written

recommendation from HHS, has

approved your laboratory as meeting

HHS laboratory certification standards

or deemed your laboratory fully

equivalent to a laboratory meeting HHS

laboratory certification standards for all

testing required under this part; or

(2) The DOT, based on a written

recommendation from HHS, has

recognized a Canadian or Mexican

certifying organization as having

equivalent laboratory certification

standards and procedures to those of

HHS, and the Canadian or Mexican

certifying organization has certified

your laboratory under those equivalent

standards and procedures.

(c) As a laboratory participating in the

DOT drug testing program, you must

comply with the requirements of this

part. You must also comply with all

applicable requirements of HHS in

testing DOT specimens, whether or not

the HHS requirements are explicitly

stated in this part.

(d) If DOT determines that you are in

noncompliance with this part, you

could be subject to PIE proceedings

under Subpart R of this part. If the

Department issues a PIE with respect to

you, you are ineligible to participate in

the DOT drug testing program even if

you continue to meet the requirements

of paragraph (a) or (b) of this section.

§ 40.83 How do laboratories process

incoming specimens?

As the laboratory, you must do the

following when you receive a DOT

specimen:

(a) You are authorized to receive only

the laboratory copy of the CCF. You are

not authorized to receive other copies of

the CCF nor any copies of the alcohol

testing form.

(b) You must comply with applicable

provisions of the HHS Guidelines

concerning accessioning and processing

urine drug specimens.

(c) You must inspect each specimen

and CCF for the following ‘‘fatal flaws:’’

(1) The specimen ID numbers on the

specimen bottle and the CCF do not

match;

(2) The specimen bottle seal is broken

or shows evidence of tampering, unless

a split specimen can be redesignated

(see paragraph (g) of this section);

(3) The collector’s printed name and

signature are omitted from the CCF; and

(4) There is an insufficient amount of

urine in the primary bottle for analysis,

unless the specimens can be

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79539

redesignated (see paragraph (g) of this

section).

(d) When you find a specimen

meeting the criteria of paragraph (c) of

this section, you must document your

findings and stop the testing process.

Report the result in accordance with

§ 40.97(a)(3) .

(e) You must inspect each specimen

and CCF for the following ‘‘correctable

flaws’’:

(1) The specimen temperature was not

checked and the ‘‘Remarks’’ line did not

contain an entry regarding the

temperature being outside of range; and

(2) The collector’s signature is omitted

on the certification statement on the

CCF.

(f) Upon finding that a specimen

meets the criteria of paragraph (e) of this

section, document the flaw and

continue the testing process.

(1) In such a case, you must retain the

specimen for a minimum of 5 business

days from the date on which you

initiated action to correct the flaw.

(2) You must then attempt to correct

the flaw by following the procedures of

§ 40.205(b).

(3) If the flaw is not corrected, report

the result in accordance with

§ 40.97(a)(3).

(g) If the CCF is marked indicating

that a split specimen collection was

collected and if the split specimen does

not accompany the primary, has leaked,

or is otherwise unavailable for testing,

you must still test the primary specimen

and follow appropriate procedures

outlined in § 40.175(b) regarding the

unavailability of the split specimen for

testing.

(1) The primary specimen and the

split specimen can be redesignated (i.e.,

Bottle B is redesignated as Bottle A, and

vice-versa) if:

(i) The primary specimen appears to

have leaked out of its sealed bottle and

the laboratory believes a sufficient

amount of urine exists in the split

specimen to conduct all appropriate

primary laboratory testing; or

(ii) The primary specimen is labeled

as Bottle B, and the split specimen as

Bottle A; or

(iii) The laboratory opens the split

specimen instead of the primary

specimen, the primary specimen

remains sealed, and the laboratory

believes a sufficient amount of urine

exists in the split specimen to conduct

all appropriate primary laboratory

testing; or

(iv) The primary specimen seal is

broken but the split specimen remains

sealed and the laboratory believes a

sufficient amount of urine exists in the

split specimen to conduct all

appropriate primary laboratory testing.

(2) In situations outlined in paragraph

(g)(1) of this section, the laboratory shall

mark through the ‘‘A’’ and write ‘‘B,’’

then initial and date the change. A

corresponding change shall be made to

the other bottle by marking through the

‘‘B’’ and writing ‘‘A,’’ and initialing and

dating the change.

(h) A notation shall be made on Copy

1 of the CCF (Step 5a) and on any

laboratory internal chain of custody

documents, as appropriate, for any fatal

or correctable flaw.

§ 40.85 What drugs do laboratories test

for?

As a laboratory, you must test for the

following five drugs or classes of drugs

in a DOT drug test. You must not test

‘‘DOT specimens’’ for any other drugs.

(a) Marijuana metabolites.

(b) Cocaine metabolites.

(c) Amphetamines.

(d) Opiate metabolites.

(e) Phencyclidine (PCP).

§ 40.87 What are the cutoff concentrations

for initial and confirmation tests?

(a) As a laboratory, you must use the

cutoff concentrations displayed in the

following table for initial and

confirmation drug tests. All cutoff

concentrations are expressed in

nanograms per milliliter (ng/mL). The

table follows:

Type of drug or metabolite Initial test Confirmation test

(1) Marijuana metabolites .............................................................

(i) Delta-9-tetrahydrocanna-binol-9-carboxylic acid (THC) ...........

50

15

(2) Cocaine metabolites (Benzoylecgonine) ................................. 300 150

(3) Phencyclidine (PCP) ................................................................ 25 25

(4) Amphetamines ......................................................................... 1000

(i) Amphetamine ............................................................................ .................... 500

(ii) Methamphetamine ................................................................... .................... 500 (Specimen must also contain amphetamine at a concentration of greater than or equal to 200 ng/mL.)

(5) Opiate metabolites ................................................................... 2000

(i) Codeine ..................................................................................... .................... 2000

(ii) Morphine .................................................................................. .................... 2000

(iii) 6-acetylmorphine (6–AM) ........................................................ .................... 10 (Test for 6–AM in the specimen. Conduct this test only

when specimen contains morphine at a concentration greater

than or equal to 2000 ng/mL.)

(b) On an initial drug test, you must

report a result below the cutoff

concentration as negative. If the result is

at or above the cutoff concentration, you

must conduct a confirmation test.

(c) On a confirmation drug test, you

must report a result below the cutoff

concentration as negative and a result at

or above the cutoff concentration as

confirmed positive.

(d) You must report quantitative

values for morphine or codeine at

15,000 ng/mL or above.

§ 40.89 What is validity testing, and are

laboratories required to conduct it?

(a) Specimen validity testing is the

evaluation of the specimen to determine

if it is consistent with normal human

urine. The purpose of validity testing is

to determine whether certain

adulterants or foreign substances were

added to the urine, if the urine was

diluted, or if the specimen was

substituted.

(b) As a laboratory, you must conduct

validity testing.

§ 40.91 What validity tests must

laboratories conduct on primary

specimens?

As a laboratory, when you conduct

validity testing under § 40.89, you must

conduct it in accordance with the

requirements of this section.

(a) You must test each primary

specimen for creatinine. You must also

determine its specific gravity if you find

that the creatinine concentration is less

than 20 mg/dL.

(b) You must measure the pH of each

primary specimen.

(c) You must test each primary

specimen to determine if it contains

79540 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

substances that may be used to

adulterate the specimen. Your tests

must have the capability of determining

whether any substance identified in

current HHS requirements or specimen

validity guidance is present in the

specimen.

(d) If you suspect the presence of an

interfering substance/adulterant that

could make a test result invalid, but you

are unable to identify it (e.g., a new

adulterant), you must, as the first

laboratory, send the specimen to

another HHS certified laboratory that

has the capability of doing so.

(e) If you identify a substance in a

specimen that appears to be an

adulterant, but which is not listed in

current HHS requirements or guidance,

you must report the finding in writing

to ODAPC and the Division of

Workplace Programs, HHS, within three

business days. You must also complete

testing of the specimen for drugs, to the

extent technically feasible.

(f) You must conserve as much as

possible of the specimen for possible

future testing.

§ 40.93 What criteria do laboratories use to

establish that a specimen is dilute or

substituted?

(a) As a laboratory you must consider

the primary specimen to be dilute if the

creatinine concentration is less than 20

mg/dL and the specific gravity is less

than 1.003, unless the criteria for a

substituted specimen are met.

(b) As a laboratory you must consider

the primary specimen to be substituted

if the creatinine concentration is less

than or equal to 5 mg/dL and the

specific gravity is less than or equal to

1.001 or greater than or equal to 1.020.

§ 40.95 What criteria do laboratories use to

establish that a specimen is adulterated?

(a) As a laboratory, you must consider

the primary specimen to be adulterated

if you determine that—

(1) A substance that is not expected to

be present in human urine is identified

in the specimen;

(2) A substance that is expected to be

present in human urine is identified at

a concentration so high that it is not

consistent with human urine; or

(3) The physical characteristics of the

specimen are outside the normal

expected range for human urine.

(b) In making your determination

under paragraph (a) of this section, you

must apply the criteria in current HHS

requirements or specimen validity

guidance.

§ 40.97 What do laboratories report and

how do they report it?

(a) As a laboratory, you must report

the results for each primary specimen

tested as one of the following:

(1) Negative;

(2) Negative—dilute;

(3) Rejected for testing, with

remark(s);

(4) Positive, with drug(s)/metabolite(s)

noted;

(5) Positive, with drug(s)/metabolite(s)

noted—dilute;

(6) Adulterated, with remark(s);

(7) Substituted, with remark(s); or

(8) Invalid result, with remark(s).

(b) As a laboratory, you must report

laboratory results directly, and only, to

the MRO at his or her place of business.

You must not report results to or

through the DER or a service agent (e.g.,

C/TPA).

(1) Negative results: You must fax,

courier, mail, or electronically transmit

a legible image or copy of the fullycompleted Copy 1 of the CCF which has

been signed by the certifying scientist,

or you may provide the laboratory

results report electronically (i.e.,

computer data file).

(i) If you elect to provide the

laboratory results report, you must

include the following elements, as a

minimum, in the report format:

(A) Laboratory name;

(B) Employer’s name (you may

include I.D. or account number;

(C) Specimen I.D. number;

(D) Donor’s SSN or employee I.D.

number, if provided; ‘

(E) Reason for test, if provided;

(F) Date of the collection;

(G) Date received at the laboratory;

(H) Date certifying scientist released

the results;

(I) Results (e.g., positive, adulterated)

as listed in paragraph (a) of this section;

and

(J) Remarks section, with an

explanation of any situation in which a

correctable flaw has been corrected.

(ii) The laboratory results report may

be released only after review and

approval by the certifying scientist and

must reflect the same test result

information as contained on the CCF

signed by the certifying scientist.

(iii) The results report may be

transmitted through any means that

ensures accuracy and confidentiality.

You, as the laboratory, together with the

MRO, must ensure that the information

is adequately protected from

unauthorized access or release, both

during transmission and in storage.

(2) Non-negative results: You must

fax, courier, mail, or electronically

transmit a legible image or copy of the

fully-completed Copy 1 of the CCF that

has been signed by the certifying

scientist. In addition, you may provide

the electronic laboratory results report

following the format and procedures set

forth in paragraphs (b)(1)(i) and (ii) of

this section.

(c) In transmitting laboratory results

to the MRO, you, as the laboratory,

together with the MRO, must ensure

that the information is adequately

protected from unauthorized access or

release, both during transmission and in

storage. If the results are provided by

fax, the fax connection must have a

fixed telephone number accessible only

to authorized individuals.

(d) You must transmit test results to

the MRO in a timely manner, preferably

the same day that review by the

certifying scientist is completed.

(e) You must provide quantitative

values for confirmed positive drug,

adulterated, and substituted test results

to the MRO when the MRO requests you

to do so in writing. The MRO’s request

may either be a general request covering

all such results you send to the MRO or

a specific case-by-case request.

(f) You must provide quantitative

values for confirmed opiate results for

morphine or codeine at 15,000 ng/mL or

above, even if the MRO has not

requested quantitative values for the test

result.

§ 40.99 How long does the laboratory

retain specimens after testing?

(a) As a laboratory testing the primary

specimen, you must retain a specimen

that was reported with positive,

adulterated, substituted, or invalid

results for a minimum of one year.

(b) You must keep such a specimen in

secure, long-term, frozen storage in

accordance with HHS requirements.

(c) Within the one-year period, the

MRO, the employee, the employer, or a

DOT agency may request in writing that

you retain a specimen for an additional

period of time (e.g., for the purpose of

preserving evidence for litigation or a

safety investigation). If you receive such

a request, you must comply with it. If

you do not receive such a request, you

may discard the specimen at the end of

the year.

(d) If you have not sent the split

specimen to another laboratory for

testing, you must retain the split

specimen for an employee’s test for the

same period of time that you retain the

primary specimen and under the same

storage conditions.

(e) As the laboratory testing the split

specimen, you must meet the

requirements of paragraphs (a) through

(d) of this section with respect to the

split specimen.

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79541

§ 40.101 What relationship may a

laboratory have with an MRO?

(a) As a laboratory, you may not enter

into any relationship with an MRO that

creates a conflict of interest or the

appearance of a conflict of interest with

the MRO’s responsibilities for the

employer. You may not derive any

financial benefit by having an employer

use a specific MRO.

(b) The following are examples of

relationships between laboratories and

MROs that the Department regards as

creating conflicts of interest, or the

appearance of such conflicts. This

following list of examples is not

intended to be exclusive or exhaustive:

(1) The laboratory employs an MRO

who reviews test results produced by

the laboratory;

(2) The laboratory has a contract or

retainer with the MRO for the review of

test results produced by the laboratory;

(3) The laboratory designates which

MRO the employer is to use, gives the

employer a slate of MROs from which

to choose, or recommends certain

MROs;

(4) The laboratory gives the employer

a discount or other incentive to use a

particular MRO;

(5) The laboratory has its place of

business co-located with that of an MRO

or MRO staff who review test results

produced by the laboratory; or

(6) The laboratory permits an MRO, or

an MRO’s organization, to have a

financial interest in the laboratory.

§ 40.103 What are the requirements for

submitting blind specimens to a

laboratory?

(a) As an employer or C/TPA with an

aggregate of 2000 or more DOT-covered

employees, you must send blind

specimens to laboratories you use. If

you have an aggregate of fewer than

2000 DOT-covered employees, you are

not required to provide blind

specimens.

(b) To each laboratory to which you

send at least 100 specimens in a year,

you must transmit a number of blind

specimens equivalent to one percent of

the specimens you send to that

laboratory, up to a maximum of 50 blind

specimens in each quarter (i.e., January–

March, April–June, July–September,

October–December). As a C/TPA, you

must apply this percentage to the total

number of DOT-covered employees’

specimens you send to the laboratory.

Your blind specimen submissions must

be evenly spread throughout the year.

The following examples illustrate how

this requirement works:

Example 1 to Paragraph (b). You send 2500

specimens to Lab X in Year 1. In this case,

you would send 25 blind specimens to Lab

X in Year 1. To meet the even distribution

requirement, you would send 6 in each of

three quarters and 7 in the other.

Example 2 to Paragraph (b). You send 2000

specimens to Lab X and 1000 specimens to

Lab Y in Year 1. In this case, you would send

20 blind specimens to Lab X and 10 to Lab

Y in Year 1. The even distribution

requirement would apply in a similar way to

that described in Example 1.

Example 3 to Paragraph (b). Same as

Example 2, except that you also send 20

specimens to Lab Z. In this case, you would

send blind specimens to Labs X and Y as in

Example 2. You would not have to send any

blind specimens to Lab Z, because you sent

fewer than 100 specimens to Lab Z.

Example 4 to Paragraph (b). You are a C/

TPA sending 2000 specimens to Lab X in

Year 1. These 2000 specimens represent 200

small employers who have an average of 10

covered employees each. In this case you—

not the individual employers—send 20 blind

specimens to Lab X in Year 1, again ensuring

even distribution. The individual employers

you represent are not required to provide any

blind specimens on their own.

Example 5 to Paragraph (b). You are a large

C/TPA that sends 40,000 specimens to Lab Y

in Year 1. One percent of that figure is 400.

However, the 50 blind specimen per quarter

‘‘cap’’ means that you need send only 50

blind specimens per quarter, rather than the

100 per quarter you would have to send to

meet the one percent rate. Your annual total

would be 200, rather than 400, blind

specimens.

(c) Approximately 75 percent of the

specimens you submit must be blank

(i.e., containing no drugs, nor

adulterated or substituted).

Approximately 15 percent must be

positive for one or more of the five

drugs involved in DOT tests, and

approximately 10 percent must either be

adulterated with a substance cited in

HHS guidance or substituted (i.e.,

having specific gravity and creatinine

meeting the criteria of § 40.93(b)).

(1) The blind specimens that you

submit that contain drugs, that are

adulterated with a substance cited in

HHS guidance, or that are substituted

must be validated as to their contents by

the supplier using initial and

confirmatory tests.

(2) The supplier must provide

information regarding the shelf life of

the blind specimens.

(3) If the blind specimen is drug

positive, the concentration of drug it

contains must be between 1.5 and 2

times the initial drug test cutoff

concentration.

(4) If the blind specimen is

adulterated with nitrite, the

concentration of nitrite it contains must

be between 1.5 and 2 times the initial

validity test cutoff concentration.

(5) If the blind specimen is

adulterated by altering pH, the pH must

be less than or equal to 2, or greater than

or equal to 12.

(6) If the blind specimen is

substituted, the creatinine must be less

than or equal to 2, and the specific

gravity must be 1.000.

(d) You must ensure that each blind

specimen is indistinguishable to the

laboratory from a normal specimen.

(1) You must submit blind specimens

to the laboratory using the same

channels (e.g., via a regular collection

site) through which employees’

specimens are sent to the laboratory.

(2) You must ensure that the collector

uses a CCF, places fictional initials on

the specimen bottle label/seal, indicates

for the MRO on Copy 2 that the

specimen is a blind specimen, and

discards Copies 4 and 5 (employer and

employee copies).

(3) You must ensure that all blind

specimens include split specimens.

§ 40.105 What happens if the laboratory

reports a result different from that expected

for a blind specimen?

(a) If you are an employer, MRO, or

C/TPA who submits a blind specimen,

and if the result reported to the MRO is

different from the result expected, you

must investigate the discrepancy.

(b) If the unexpected result is a false

negative, you must provide the

laboratory with the expected results

(obtained from the supplier of the blind

specimen), and direct the laboratory to

determine the reason for the

discrepancy.

(c) If the unexpected result is a false

positive, you must provide the

laboratory with the expected results

(obtained from the supplier of the blind

specimen), and direct the laboratory to

determine the reason for the

discrepancy. You must also notify

ODAPC of the discrepancy by telephone

(202–366–3784) or e-mail (addresses are

listed on the ODAPC web site, http://

www.dot.gov/ost/dapc). ODAPC will

notify HHS who will take appropriate

action.

§ 40.107 Who may inspect laboratories?

As a laboratory, you must permit an

inspection, with or without prior notice,

by ODAPC, a DOT agency, or a DOTregulated employer that contracts with

the laboratory for drug testing under the

DOT drug testing program, or the

designee of such an employer.

§ 40.109 What documentation must the

laboratory keep, and for how long?

(a) As a laboratory, you must retain all

records pertaining to each employee

urine specimen for a minimum of two

years.

(b) As a laboratory, you must also

keep for two years employer-specific

data required in § 40.111.

79542 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

(c) Within the two-year period, the

MRO, the employee, the employer, or a

DOT agency may request in writing that

you retain the records for an additional

period of time (e.g., for the purpose of

preserving evidence for litigation or a

safety investigation). If you receive such

a request, you must comply with it. If

you do not receive such a request, you

may discard the records at the end of

the two-year period.

§ 40.111 When and how must a laboratory

disclose statistical summaries and other

information it maintains?

(a) As a laboratory, you must transmit

an aggregate statistical summary, by

employer, of the data listed in Appendix

B to this part to the employer on a semiannual basis.

(1) The summary must not reveal the

identity of any employee.

(2) In order to avoid sending data

from which it is likely that information

about an employee’s test result can be

readily inferred, you must not send a

summary if the employer has fewer than

five aggregate tests results.

(3) The summary must be sent by

January 20 of each year for July 1

through December 31 of the prior year.

(4) The summary must also be sent by

July 20 of each year for January 1

through June 30 of the current year.

(b) When the employer requests a

summary in response to an inspection,

audit, or review by a DOT agency, you

must provide it unless the employer had

fewer than five aggregate test results. In

that case, you must send the employer

a report indicating that not enough

testing was conducted to warrant a

summary. You may transmit the

summary or report by hard copy, fax, or

other electronic means.

(c) You must also release information

to appropriate parties as provided in

§§ 40.329 and 40.331.

§ 40.113 Where is other information

concerning laboratories found in this

regulation?

You can find more information

concerning laboratories in several

sections of this part:

§ 40.3—Definition.

§ 40.13—Prohibition on making specimens

available for other purposes.

§ 40.31—Conflicts of interest concerning

collectors.

§ 40.47—Laboratory rejections of test for

improper form.

§ 40.125—Conflicts of interest concerning

MROs.

§ 40.175—Role of first laboratory in split

specimen tests.

§ 40.177—Role of second laboratory in split

specimen tests (drugs).

§ 40.179—Role of second laboratory in split

specimen tests (adulterants).

§ 40.181—Role of second laboratory in split

specimen tests (substitution).

§§ 40.183–40.185—Transmission of split

specimen test results to MRO.

§§ 40.201–40.205—Role in correcting errors.

§ 40.329—Release of information to

employees.

§ 40.331—Limits on release of information.

§ 40.355—Role with respect to other service

agents.

Subpart G—Medical Review Officers

and the Verification Process

§ 40.121 Who is qualified to act as an

MRO?

To be qualified to act as an MRO in

the DOT drug testing program, you must

meet each of the requirements of this

section:

(a) Credentials. You must be a

licensed physician (Doctor of Medicine

or Osteopathy). If you are a licensed

physician in any U.S., Canadian, or

Mexican jurisdiction and meet the other

requirements of this section, you are

authorized to perform MRO services

with respect to all covered employees,

wherever they are located. For example,

if you are licensed as an M.D. in one

state or province in the U.S., Canada, or

Mexico, you are not limited to

performing MRO functions in that state

or province, and you may perform MRO

functions for employees in other states

or provinces without becoming licensed

to practice medicine in the other

jurisdictions.

(b) Basic knowledge. You must be

knowledgeable in the following areas:

(1) You must be knowledgeable about

and have clinical experience in

controlled substances abuse disorders,

including detailed knowledge of

alternative medical explanations for

laboratory confirmed drug test results.

(2) You must be knowledgeable about

issues relating to adulterated and

substituted specimens as well as the

possible medical causes of specimens

having an invalid result.

(3) You must be knowledgeable about

this part, the DOT MRO Guidelines, and

the DOT agency regulations applicable

to the employers for whom you evaluate

drug test results, and you must keep

current on any changes to these

materials. The DOT MRO Guidelines

document is available from ODAPC

(Department of Transportation, 400 7th

Street, SW., Room 10403, Washington,

DC 20590, 202–366–3784, or on the

ODAPC web site (http://www.dot.gov/

ost/dapc)).

(c) Qualification training. You must

receive qualification training meeting

the requirements of this paragraph (c).

(1) Qualification training must

provide instruction on the following

subjects:

(i) Collection procedures for urine

specimens;

(ii) Chain of custody, reporting, and

recordkeeping;

(iii) Interpretation of drug and validity

tests results;

(iv) The role and responsibilities of

the MRO in the DOT drug testing

program;

(v) The interaction with other

participants in the program (e.g., DERs,

SAPs); and

(vi) Provisions of this part and DOT

agency rules applying to employers for

whom you review test results, including

changes and updates to this part and

DOT agency rules, guidance,

interpretations, and policies affecting

the performance of MRO functions, as

well as issues that MROs confront in

carrying out their duties under this part

and DOT agency rules.

(2) Following your completion of

qualification training under paragraph

(c)(1) of this section, you must

satisfactorily complete an examination

administered by a nationally-recognized

MRO certification board or subspecialty

board for medical practitioners in the

field of medical review of DOTmandated drug tests. The examination

must comprehensively cover all the

elements of qualification training listed

in paragraph (c)(1) of this section.

(3) The following is the schedule for

qualification training you must meet:

(i) If you became an MRO before

August 1, 2001, and have already met

the qualification training requirement,

you do not have to meet it again.

(ii) If you became an MRO before

August 1, 2001, but have not yet met the

qualification training requirement, you

must do so no later than January 31,

2003.

(iii) If you become an MRO on or after

August 1, 2001, you must meet the

qualification training requirement

before you begin to perform MRO

functions.

(d) Continuing Education. During

each three-year period from the date on

which you satisfactorily complete the

examination under paragraph (c)(2) of

this section, you must complete

continuing education consisting of at

least 12 professional development hours

(e.g., Continuing Education Medical

Units) relevant to performing MRO

functions.

(1) This continuing education must

include material concerning new

technologies, interpretations, recent

guidance, rule changes, and other

information about developments in

MRO practice, pertaining to the DOT

program, since the time you met the

qualification training requirements of

this section.

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79543

(2) Your continuing education

activities must include assessment tools

to assist you in determining whether

you have adequately learned the

material.

(e) Documentation. You must

maintain documentation showing that

you currently meet all requirements of

this section. You must provide this

documentation on request to DOT

agency representatives and to employers

and C/TPAs who are using or

negotiating to use your services.

§ 40.123 What are the MRO’s

responsibilities in the DOT drug testing

program?

As an MRO, you have the following

basic responsibilities:

(a) Acting as an independent and

impartial ‘‘gatekeeper’’ and advocate for

the accuracy and integrity of the drug

testing process.

(b) Providing a quality assurance

review of the drug testing process for

the specimens under your purview. This

includes, but is not limited to:

(1) Ensuring the review of the CCF on

all specimen collections for the

purposes of determining whether there

is a problem that may cause a test to be

cancelled (see §§ 40.199–40.203 ). As an

MRO, you are not required to review

laboratory internal chain of custody

documentation. No one is permitted to

cancel a test because you have not

reviewed this documentation;

(2) Providing feedback to employers,

collection sites and laboratories

regarding performance issues where

necessary; and

(3) Reporting to and consulting with

the ODAPC or a relevant DOT agency

when you wish DOT assistance in

resolving any program issue. As an

employer or service agent, you are

prohibited from limiting or attempting

to limit the MRO’s access to DOT for

this purpose and from retaliating in any

way against an MRO for discussing drug

testing issues with DOT.

(c) You must determine whether there

is a legitimate medical explanation for

confirmed positive, adulterated,

substituted, and invalid drug tests

results from the laboratory.

(d) While you provide medical review

of employees’ test results, this part does

not deem that you have established a

doctor-patient relationship with the

employees whose tests you review.

(e) You must act to investigate and

correct problems where possible and

notify appropriate parties (e.g., HHS,

DOT, employers, service agents) where

assistance is needed, (e.g., cancelled or

problematic tests, incorrect results,

problems with blind specimens).

(f) You must ensure the timely flow of

test results and other information to

employers.

(g) You must protect the

confidentiality of the drug testing

information.

(h) You must perform all your

functions in compliance with this part

and other DOT agency regulations.

§ 40.125 What relationship may an MRO

have with a laboratory?

As an MRO, you may not enter into

any relationship with an employer’s

laboratory that creates a conflict of

interest or the appearance of a conflict

of interest with your responsibilities to

that employer. You may not derive any

financial benefit by having an employer

use a specific laboratory. For examples

of relationships between laboratories

and MROs that the Department views as

creating a conflict of interest or the

appearance of such a conflict, see

§ 40.101(b).

§ 40.127 What are the MRO’s functions in

reviewing negative test results?

As the MRO, you must do the

following with respect to negative drug

test results you receive from a

laboratory, prior to verifying the result

and releasing it to the DER:

(a) Review Copy 2 of the CCF to

determine if there are any fatal or

correctable errors that may require you

to initiate corrective action or to cancel

the test (see §§ 40.199 and 40.203).

(b) Review the negative laboratory test

result and ensure that it is consistent

with the information contained on the

CCF.

(c) Before you report a negative test

result, you must have in your

possession the following documents:

(1) Copy 2 of the CCF, a legible copy

of it, or any other CCF copy containing

the employee’s signature; and

(2) A legible copy (fax, photocopy,

image) of Copy 1 of the CCF or the

electronic laboratory results report that

conveys the negative laboratory test

result.

(d) If the copy of the documentation

provided to you by the collector or

laboratory appears unclear, you must

request that the collector or laboratory

send you a legible copy.

(e) On Copy 2 of the CCF, place a

check mark in the ‘‘Negative’’ box (Step

6), provide your name, and sign, initial,

or stamp and date the verification

statement.

(f) Report the result in a confidential

manner (see §§ 40.163–40.167).

(g) Staff under your direct, personal

supervision may the administrative

functions of this section for you, but

only you can cancel a test.

(1) On specimen results that are

reviewed by your staff, you are

responsible for assuring the quality of

their work.

(2) You are required to personally

review at least 5 percent of all CCFs

reviewed by your staff on a quarterly

basis, including all results that required

a corrective action. However, you need

not review more than 500 negative

results in any quarter.

(3) Your review must, as a minimum,

include the CCF, negative laboratory test

result, any accompanying corrective

documents, and the report sent to the

employer. You must correct any errors

that you discover. You must take action

as necessary to ensure compliance by

your staff with this part and document

your corrective action. You must attest

to the quality assurance review by

initialing the CCFs that you review.

(4) You must make these CCFs easily

identifiable and retrievable by you for

review by DOT agencies.

§ 40.129 What are the MRO’s functions in

reviewing laboratory confirmed positive,

adulterated, substituted, or invalid drug test

results?

(a) As the MRO, you must do the

following with respect to confirmed

positive, adulterated, substituted, or

invalid drug tests you receive from a

laboratory, before you verify the result

and release it to the DER:

(1) Review Copy 2 of the CCF to

determine if there are any fatal or

correctable errors that may require you

to cancel the test (see §§ 40.199 and

40.203). Staff under your direct,

personal supervision may conduct this

administrative review for you, but only

you may verify or cancel a test.

(2) Review Copy 1 of the CCF and

ensure that it is consistent with the

information contained on Copy 2, that

the test result is legible, and that the

certifying scientist signed the form. You

are not required to review any other

documentation generated by the

laboratory during their analysis or

handling of the specimen (e.g., the

laboratory internal chain of custody).

(3) If the copy of the documentation

provided to you by the collector or

laboratory appears unclear, you must

request that the collector or laboratory

send you a legible copy.

(4) Except in the circumstances

spelled out in § 40.133 , conduct a

verification interview. This interview

must include direct contact in person or

by telephone between you and the

employee. You may initiate the

verification process based on the

laboratory results report.

(5) Verify the test result as either

negative, positive, test cancelled, or

79544 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

refusal to test because of adulteration or

substitution, consistent with the

requirements of §§ 40.135–40.145 and

40.159 .

(b) Before you report a verified

negative, positive, test cancelled, refusal

to test because of adulteration or

substitution, you must have in your

possession the following documents:

(1) Copy 2 of the CCF, a legible copy

of it, or any other CCF copy containing

the employee’s signature; and

(2) A legible copy (fax, photocopy,

image) of Copy 1 of the CCF, containing

the certifying scientist’s signature.

(c) With respect to verified positive

test results, place a check mark in the

‘‘Positive’’ box (Step 6) on Copy 2 of the

CCF, indicate the drug(s)/ metabolite(s)

detected on the ‘‘Remarks’’ line, sign

and date the verification statement.

(d) Report the result in a confidential

manner (see §§ 40.163–40.167 ).

(e) With respect to adulteration or

substitution test results, check the

‘‘refusal to test because:’’ box (Step 6) on

Copy 2 of the CCF, check the

‘‘Adulterated’’ or ‘‘Substituted’’ box, as

appropriate, make appropriate

annotation in the ‘‘Remarks’’ line, sign

and date the verification statement.

(f) As the MRO, your actions

concerning reporting confirmed

positive, adulterated, or substituted

results to the employer before you have

completed the verification process are

also governed by the stand-down

provisions of § 40.21 .

(1) If an employer has a stand-down

policy that meets the requirements of

§ 40.21 , you may report to the DER that

you have received an employee’s

laboratory confirmed positive,

adulterated, or substituted test result,

consistent with the terms of the waiver

the employer received. You must not

provide any further details about the

test result (e.g., the name of the drug

involved).

(2) If the employer does not have a

stand-down policy that meets the

requirements of § 40.21 , you must not

inform the employer that you have

received an employee’s laboratory

confirmed positive, adulterated, or

substituted test result until you verify

the test result. For example, as an MRO

employed directly by a company, you

must not tell anyone on the company’s

staff or management that you have

received an employee’s laboratory

confirmed test result.

§ 40.131 How does the MRO or DER notify

an employee of the verification process

after a confirmed positive, adulterated,

substituted, or invalid test result?

(a) When, as the MRO, you receive a

confirmed positive, adulterated,

substituted, or invalid test result from

the laboratory, you must contact the

employee directly (i.e., actually talk to

the employee), on a confidential basis,

to determine whether the employee

wants to discuss the test result. In

making this contact, you must explain

to the employee that, if he or she

declines to discuss the result, you will

verify the test as positive or as a refusal

to test because of adulteration or

substitution, as applicable.

(b) As the MRO, staff under your

personal supervision may conduct this

initial contact for you.

(1) This staff contact must be limited

to scheduling the discussion between

you and the employee and explaining

the consequences of the employee’s

declining to speak with you (i.e., that

the MRO will verify the test without

input from the employee). If the

employee declines to speak with you,

the staff person must document the

employee’s decision, including the date

and time.

(2) A staff person must not gather any

medical information or information

concerning possible explanations for the

test result.

(3) A staff person may advise an

employee to have medical information

(e.g., prescriptions, information forming

the basis of a legitimate medical

explanation for a confirmed positive test

result) ready to present at the interview

with the MRO.

(4) Since you are required to speak

personally with the employee, face-toface or on the phone, your staff must not

inquire if the employee wishes to speak

with you.

(c) As the MRO, you or your staff

must make reasonable efforts to reach

the employee at the day and evening

telephone numbers listed on the CCF.

Reasonable efforts include, as a

minimum, three attempts, spaced

reasonably over a 24-hour period, to

reach the employee at the day and

evening telephone numbers listed on

the CCF. If you or your staff cannot

reach the employee directly after

making these efforts, you or your staff

must take the following steps:

(1) Document the efforts you made to

contact the employee, including dates

and times. If both phone numbers are

incorrect (e.g., disconnected, wrong

number), you may take the actions listed

in paragraph (c)(2) of this section

without waiting the full 24-hour period.

(2) Contact the DER, instructing the

DER to contact the employee.

(i) You must simply direct the DER to

inform the employee to contact you.

(ii) You must not inform the DER that

the employee has a confirmed positive,

adulterated, substituted, or invalid test

result.

(iii) You must document the dates and

times of your attempts to contact the

DER, and you must document the name

of the DER you contacted and the date

and time of the contact.

(d) As the DER, you must attempt to

contact the employee immediately,

using procedures that protect, as much

as possible, the confidentiality of the

MRO’s request that the employee

contact the MRO. If you successfully

contact the employee (i.e., actually talk

to the employee), you must document

the date and time of the contact, and

inform the MRO. You must inform the

employee that he or she must contact

the MRO within the next 72 hours and

tell the employee the consequences of

failing to do so (see § 40.133(a)(2)).

(1) As the DER, you must not inform

anyone else working for the employer

that you are seeking to contact the

employee on behalf of the MRO.

(2) If, as the DER, you have made all

reasonable efforts to contact the

employee but failed to do so, you may

place the employee on temporary

medically unqualified status or medical

leave. Reasonable efforts include, as a

minimum, three attempts, spaced

reasonably over a 24-hour period, to

reach the employee at the day and

evening telephone numbers listed on

the CCF.

(i) As the DER, you must document

the dates and times of these efforts.

(ii) If, as the DER, you are unable to

contact the employee within this 24-

hour period, you must leave a message

for the employee by any practicable

means (e.g., voice mail, e-mail, letter) to

contact the MRO and inform the MRO

of the date and time of this attempted

contact.

§ 40.133 Under what circumstances may

the MRO verify a test as positive, or as a

refusal to test because of adulteration or

substitution, without interviewing the

employee?

(a) As the MRO, you normally may

verify a confirmed positive test (for any

drug or drug metabolite, including

opiates), or as a refusal to test because

of adulteration or substitution, only

after interviewing the employee as

provided in §§ 40.135–40.145 .

However, there are three circumstances

in which you may verify such a result

without an interview:

(1) You may verify a test result as a

positive or refusal to test, as applicable,

if the employee expressly declines the

opportunity to discuss the test with you.

You must maintain complete

documentation of this occurrence,

including notation of informing, or

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79545

attempting to inform, the employee of

the consequences of not exercising the

option to speak with the you.

(2) You may verify a test result as a

positive or refusal to test, as applicable,

if the DER has successfully made and

documented a contact with the

employee and instructed the employee

to contact you and more than 72 hours

have passed since the time the DER

contacted the employee.

(3) You may verify a test result as a

positive or refusal to test, as applicable,

if neither you nor the DER, after making

and documenting all reasonable efforts,

has been able to contact the employee

within ten days of the date on which the

MRO receives the confirmed test result

from the laboratory.

(b) As the MRO, when you verify a

test result as a positive or refusal to test

under this section, you must document

the date, time and reason, following the

instructions in § 40.163 .

(c) As the MRO, after you have

verified a test result as a positive or

refusal to test under this section and

reported the result to the DER, you must

allow the employee to present

information to you within 60 days of the

verification documenting that serious

illness, injury, or other circumstances

unavoidably precluded contact with the

MRO and/or DER in the times provided.

On the basis of such information, you

may reopen the verification, allowing

the employee to present information

concerning whether there is a legitimate

medical explanation for the confirmed

test result.

§ 40.135 What does the MRO tell the

employee at the beginning of the

verification interview?

(a) As the MRO, you must tell the

employee that the laboratory has

determined that the employee’s test

result was positive, adulterated,

substituted, or invalid, as applicable.

You must also tell the employee of the

drugs for which his or her specimen

tested positive, or the basis for the

finding of adulteration or substitution.

(b) You must explain the verification

interview process to the employee and

inform the employee that your decision

will be based on information the

employee provides in the interview.

(c) You must explain that, if further

medical evaluation is needed for the

verification process, the employee must

comply with your request for this

evaluation and that failure to do so is

equivalent of expressly declining to

discuss the test result.

(d) As the MRO, you must warn an

employee who has a confirmed positive,

adulterated, substituted or invalid test

that you are required to provide to third

parties drug test result information and

medical information affecting the

performance of safety-sensitive duties

that the employee gives you in the

verification process without the

employee’s consent (see § 40.327).

(1) You must give this warning to the

employee before obtaining any medical

information as part of the verification

process.

(2) For purposes of this paragraph (d),

medical information includes

information on medications or other

substances affecting the performance of

safety-sensitive duties that the employee

reports using or medical conditions the

employee reports having.

(3) For purposes of this paragraph (d),

the persons to whom this information

may be provided include the employer,

a SAP evaluating the employee as part

of the return to duty process (see

§ 40.293(g)), DOT, another Federal

safety agency (e.g., the NTSB), or any

state safety agency as required by state

law.

(e) You must also advise the employee

that, before informing any third party

about any medication the employee is

using pursuant to a legally valid

prescription under the Controlled

Substances Act, you will, if the

employee consents, contact the

prescribing physician to determine if

the medication can be changed to one

that does not make the employee

medically unqualified or does not pose

a significant safety risk.

§ 40.137 On what basis does the MRO

verify test results involving marijuana,

cocaine, amphetamines, or PCP?

(a) As the MRO, you must verify a

confirmed positive test result for

marijuana, cocaine, amphetamines, and/

or PCP unless the employee presents a

legitimate medical explanation for the

presence of the drug(s)/metabolite(s) in

his or her system.

(b) You must offer the employee an

opportunity to present a legitimate

medical explanation in all cases.

(c) The employee has the burden of

proof that a legitimate medical

explanation exists. The employee must

present information meeting this burden

at the time of the verification interview.

As the MRO, you have discretion to

extend the time available to the

employee for this purpose for up to five

days before verifying the test result, if

you determine that there is a reasonable

basis to believe that the employee will

be able to produce relevant evidence

concerning a legitimate medical

explanation within that time.

(d) If you determine that there is a

legitimate medical explanation, you

must verify the test result as negative.

Otherwise, you must verify the test

result as positive.

(e) In determining whether a

legitimate medical explanation exists,

you may consider the employee’s use of

a medication from a foreign country.

You must exercise your professional

judgment consistently with the

following principles:

(1) There can be a legitimate medical

explanation only with respect to a

substance that is obtained legally in a

foreign country.

(2) There can be a legitimate medical

explanation only with respect to a

substance that has a legitimate medical

use. Use of a drug of abuse (e.g., heroin,

PCP, marijuana) or any other substance

(see § 40.151(f) and (g)) that cannot be

viewed as having a legitimate medical

use can never be the basis for a

legitimate medical explanation, even if

the substance is obtained legally in a

foreign country.

(3) Use of the substance can form the

basis of a legitimate medical

explanation only if it is used

consistently with its proper and

intended medical purpose.

(4) Even if you find that there is a

legitimate medical explanation under

this paragraph (e) and verify a test

negative, you may have a responsibility

to raise fitness-for-duty considerations

with the employer (see § 40.327).

§ 40.139 On what basis does the MRO

verify test results involving opiates?

As the MRO, you must proceed as

follows when you receive a laboratory

confirmed positive opiate result:

(a) If the laboratory detects the

presence of 6-acetylmorphine (6-AM) in

the specimen, you must verify the test

result positive.

(b) In the absence of 6-AM, if the

laboratory detects the presence of either

morphine or codeine at 15,000 ng/mL or

above, you must verify the test result

positive unless the employee presents a

legitimate medical explanation for the

presence of the drug or drug metabolite

in his or her system, as in the case of

other drugs (see § 40.137). Consumption

of food products (e.g., poppy seeds)

must not be considered a legitimate

medical explanation for the employee

having morphine or codeine at these

concentrations.

(c) For all other opiate positive

results, you must verify a confirmed

positive test result for opiates only if

you determine that there is clinical

evidence, in addition to the urine test,

of unauthorized use of any opium,

opiate, or opium derivative (i.e.,

morphine, heroin, or codeine).

(1) As an MRO, it is your

responsibility to use your best

79546 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

professional and ethical judgement and

discretion to determine whether there is

clinical evidence of unauthorized use of

opiates. Examples of information that

you may consider in making this

judgement include, but are not limited

to, the following:

(i) Recent needle tracks;

(ii) Behavioral and psychological

signs of acute opiate intoxication or

withdrawal;

(iii) Clinical history of unauthorized

use recent enough to have produced the

laboratory test result;

(iv) Use of a medication from a foreign

country. See § 40.137(e) for guidance on

how to make this determination.

(2) In order to establish the clinical

evidence referenced in paragraphs

(c)(1)(i) and (ii) of this section, personal

observation of the employee is essential.

(i) Therefore, you, as the MRO, must

conduct, or cause another physician to

conduct, a face-to-face examination of

the employee.

(ii) No face-to-face examination is

needed in establishing the clinical

evidence referenced in paragraph

(c)(1)(iii) or (iv) of this section.

(3) To be the basis of a verified

positive result for opiates, the clinical

evidence you find must concern a drug

that the laboratory found in the

specimen. (For example, if the test

confirmed the presence of codeine, and

the employee admits to unauthorized

use of hydrocodone, you do not have

grounds for verifying the test positive.

The admission must be for the

substance that was found).

(4) As the MRO, you have the burden

of establishing that there is clinical

evidence of unauthorized use of opiates

referenced in this paragraph (c). If you

cannot make this determination (e.g.,

there is not sufficient clinical evidence

or history), you must verify the test as

negative. The employee does not need

to show you that a legitimate medical

explanation exists if no clinical

evidence is established.

§ 40.141 How does the MRO obtain

information for the verification decision?

As the MRO, you must do the

following as you make the

determinations needed for a verification

decision:

(a) You must conduct a medical

interview. You must review the

employee’s medical history and any

other relevant biomedical factors

presented to you by the employee. You

may direct the employee to undergo

further medical evaluation by you or

another physician.

(b) If the employee asserts that the

presence of a drug or drug metabolite in

his or her specimen results from taking

prescription medication, you must

review and take all reasonable and

necessary steps to verify the

authenticity of all medical records the

employee provides. You may contact

the employee’s physician or other

relevant medical personnel for further

information.

§ 40.143 [Reserved]

§ 40.145 On what basis does the MRO

verify test results involving adulteration or

substitution?

(a) As an MRO, when you receive a

laboratory report that a specimen is

adulterated or substituted, you must

treat that report in the same way you

treat the laboratory’s report of a

confirmed positive test for a drug or

drug metabolite.

(b) You must follow the same

procedures used for verification of a

confirmed positive test for a drug or

drug metabolite (see §§ 40.129–40.135,

40.141, 40.151), except as otherwise

provided in this section.

(c) In the verification interview, you

must explain the laboratory findings to

the employee and address technical

questions or issues the employee may

raise.

(d) You must offer the employee the

opportunity to present a legitimate

medical explanation for the laboratory

findings with respect to presence of the

adulterant in, or the creatinine and

specific gravity findings for, the

specimen.

(e) The employee has the burden of

proof that there is a legitimate medical

explanation.

(1) To meet this burden in the case of

an adulterated specimen, the employee

must demonstrate that the adulterant

found by the laboratory entered the

specimen through physiological means.

(2) To meet this burden in the case of

a substituted specimen, the employee

must demonstrate that he or she did

produce or could have produced urine,

through physiological means, meeting

the creatinine and specific gravity

criteria of § 40.93(b).

(3) The employee must present

information meeting this burden at the

time of the verification interview. As the

MRO, you have discretion to extend the

time available to the employee for this

purpose for up to five days before

verifying the specimen, if you determine

that there is a reasonable basis to believe

that the employee will be able to

produce relevant evidence supporting a

legitimate medical explanation within

that time.

(f) As the MRO or the employer, you

are not responsible for arranging,

conducting, or paying for any studies,

examinations or analyses to determine

whether a legitimate medical

explanation exists.

(g) As the MRO, you must exercise

your best professional judgment in

deciding whether the employee has

established a legitimate medical

explanation.

(1) If you determine that the

employee’s explanation does not

present a reasonable basis for

concluding that there may be a

legitimate medical explanation, you

must report the test to the DER as a

verified refusal to test because of

adulteration or substitution, as

applicable.

(2) If you believe that the employee’s

explanation may present a reasonable

basis for concluding that there is a

legitimate medical explanation, you

must direct the employee to obtain,

within the five-day period set forth in

paragraph (e)(3) of this section, a further

medical evaluation. This evaluation

must be performed by a licensed

physician (the ‘‘referral physician’’),

acceptable to you, with expertise in the

medical issues raised by the employee’s

explanation. (The MRO may perform

this evaluation if the MRO has

appropriate expertise.)

(i) As the MRO or employer, you are

not responsible for finding or paying a

referral physician. However, on request

of the employee, you must provide

reasonable assistance to the employee’s

efforts to find such a physician. The

final choice of the referral physician is

the employee’s, as long as the physician

is acceptable to you.

(ii) As the MRO, you must consult

with the referral physician, providing

guidance to him or her concerning his

or her responsibilities under this

section. As part of this consultation, you

must provide the following information

to the referral physician:

(A) That the employee was required to

take a DOT drug test, but the laboratory

reported that the specimen was

adulterated or substituted, which is

treated as a refusal to test;

(B) The consequences of the

appropriate DOT agency regulation for

refusing to take the required drug test;

(C) That the referral physician must

agree to follow the requirements of

paragraphs (g)(3) through (g)(4) of this

section; and

(D) That the referral physician must

provide you with a signed statement of

his or her recommendations.

(3) As the referral physician, you must

evaluate the employee and consider any

evidence the employee presents

concerning the employee’s medical

explanation. You may conduct

additional tests to determine whether

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79547

there is a legitimate medical

explanation. Any additional urine tests

must be performed in an HHS-certified

laboratory.

(4) As the referral physician, you must

then make a written recommendation to

the MRO about whether the MRO

should determine that there is a

legitimate medical explanation. As the

MRO, you must seriously consider and

assess the referral physician’s

recommendation in deciding whether

there is a legitimate medical

explanation.

(5) As the MRO, if you determine that

there is a legitimate medical

explanation, you must cancel the test

and inform ODAPC in writing of the

determination and the basis for it (e.g.,

referral physician’s findings, evidence

produced by the employee).

(6) As the MRO, if you determine that

there is not a legitimate medical

explanation, you must report the test to

the DER as a verified refusal to test

because of adulteration or substitution.

(h) The following are examples of

types of evidence an employee could

present to support an assertion of a

legitimate medical explanation for a

substituted result.

(1) Medically valid evidence

demonstrating that the employee is

capable of physiologically producing

urine meeting the creatinine and

specific gravity criteria of § 40.93(b) .

(i) To be regarded as medically valid,

the evidence must have been gathered

using appropriate methodology and

controls to ensure its accuracy and

reliability.

(ii) Assertion by the employee that his

or her personal characteristics (e.g., with

respect to race, gender, weight, diet,

working conditions) are responsible for

the substituted result does not, in itself,

constitute a legitimate medical

explanation. To make a case that there

is a legitimate medical explanation, the

employee must present evidence

showing that the cited personal

characteristics actually result in the

physiological production of urine

meeting the creatinine and specific

gravity criteria of § 40.93(b) .

(2) Information from a medical

evaluation under paragraph (g) of this

section that the individual has a

medical condition that has been

demonstrated to cause the employee to

physiologically produce urine meeting

the creatinine and specific gravity

criteria of § 40.93(b) .

(i) A finding or diagnosis by the

physician that an employee has a

medical condition, in itself, does not

constitute a legitimate medical

explanation.

(ii) To establish there is a legitimate

medical explanation, the employee must

demonstrate that the cited medical

condition actually results in the

physiological production of urine

meeting the creatinine and specific

gravity criteria of § 40.93(b) .

§ 40.147 [Reserved]

§ 40.149 May the MRO change a verified

positive drug test result or refusal to test?

(a) As the MRO, you may change a

verified positive or refusal to test drug

test result only in the following

situations:

(1) When you have reopened a

verification that was done without an

interview with an employee (see

§ 40.133(c)).

(2) If you receive information, not

available to you at the time of the

original verification, demonstrating that

the laboratory made an error in

identifying (e.g., a paperwork mistake)

or testing (e.g., a false positive or

negative) the employee’s primary or

split specimen. For example, suppose

the laboratory originally reported a

positive test result for Employee X and

a negative result for Employee Y. You

verified the test results as reported to

you. Then the laboratory notifies you

that it mixed up the two test results, and

X was really negative and Y was really

positive. You would change X’s test

result from positive to negative and

contact Y to conduct a verification

interview.

(3) If, within 60 days of the original

verification decision—

(i) You receive information that could

not reasonably have been provided to

you at the time of the decision

demonstrating that there is a legitimate

medical explanation for the presence of

drug(s)/metabolite(s) in the employee’s

specimen; or

(ii) You receive credible new or

additional evidence that a legitimate

medical explanation for an adulterated

or substituted result exists.

Example to Paragraph (a)(3): If the

employee’s physician provides you a valid

prescription that he or she failed to find at

the time of the original verification, you may

change the test result from positive to

negative if you conclude that the prescription

provides a legitimate medical explanation for

the drug(s)/ metabolite(s) in the employee’s

specimen.

(4) If you receive the information in

paragraph (a)(3) of this section after the

60-day period, you must consult with

ODAPC prior to changing the result.

(5) When you have made an

administrative error and reported an

incorrect result.

(b) If you change the result, you must

immediately notify the DER in writing,

as provided in §§ 40.163–40.165.

(c) You are the only person permitted

to change a verified test result.

§ 40.151 What are MROs prohibited from

doing as part of the verification process?

As an MRO, you are prohibited from

doing the following as part of the

verification process:

(a) You must not consider any

evidence from tests of urine samples or

other body fluids or tissues (e.g., blood

or hair samples) that are not collected or

tested in accordance with this part. For

example, if an employee tells you he

went to his own physician, provided a

urine specimen, sent it to a laboratory,

and received a negative test result or a

DNA test result questioning the identity

of his DOT specimen, you are required

to ignore this test result.

(b) In reviewing the CCF, you must

not consider evidence extrinsic to the

CCF in determining whether the test is

valid. For example, you must review

only what is on the face of the CCF for

this purpose, not assertions by the

employee that the CCF does not

accurately reflect what happened at the

collection site.

(c) It is not your function to determine

whether the employer should have

directed that a test occur. For example,

if an employee tells you that the

employer misidentified her as the

subject of a random test, or directed her

to take a reasonable suspicion or postaccident test without proper grounds

under a DOT agency drug or alcohol

regulation, you must inform the

employee that you cannot play a role in

deciding these issues.

(d) It is not your function to consider

explanations of confirmed positive,

adulterated, or substituted test results

that would not, even if true, constitute

a legitimate medical explanation. For

example, an employee may tell you that

someone slipped amphetamines into her

drink at a party, that she unknowingly

ingested a marijuana brownie, or that

she traveled in a closed car with several

people smoking crack. MROs are

unlikely to be able to verify the facts of

such passive or unknowing ingestion

stories. Even if true, such stories do not

present a legitimate medical

explanation. Consequently, you must

not declare a test as negative based on

an explanation of this kind.

(e) You must not verify a test negative

based on information that a physician

recommended that the employee use a

drug listed in Schedule I of the

Controlled Substances Act. (e.g., under

a state law that purports to authorize

such recommendations, such as the

79548 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

‘‘medical marijuana’’ laws that some

states have adopted).

(f) You must not accept an assertion

of consumption or other use of a hemp

or other non-prescription marijuanarelated product as a basis for verifying

a marijuana test negative. You also must

not accept such an explanation related

to consumption of coca teas as a basis

for verifying a cocaine test result as

negative. Consuming or using such a

product is not a legitimate medical

explanation.

(g) You must not accept an assertion

that there is a legitimate medical

explanation for the presence of PCP or

6-AM in a specimen. There are no

legitimate medical explanations for the

presence of these substances.

(h) You must not accept, as a

legitimate medical explanation for an

adulterated specimen, an assertion that

soap, bleach, or glutaraldehyde entered

a specimen through physiological

means. There are no physiological

means through which these substances

can enter a specimen.

(i) You must not accept, as a

legitimate medical explanation for a

substituted specimen, an assertion that

an employee can produce urine with no

detectable creatinine. There are no

physiological means through which a

person can produce a urine specimen

having this characteristic.

§ 40.153 How does the MRO notify

employees of their right to a test of the split

specimen?

(a) As the MRO, when you have

verified a drug test as positive for a drug

or drug metabolite, or as a refusal to test

because of adulteration or substitution,

you must notify the employee of his or

her right to have the split specimen

tested. You must also notify the

employee of the procedures for

requesting a test of the split specimen.

(b) You must inform the employee

that he or she has 72 hours from the

time you provide this notification to

him or her to request a test of the split

specimen.

(c) You must tell the employee how

to contact you to make this request. You

must provide telephone numbers or

other information that will allow the

employee to make this request. As the

MRO, you must have the ability to

receive the employee’s calls at all times

during the 72 hour period (e.g., by use

of an answering machine with a ‘‘time

stamp’’ feature when there is no one in

your office to answer the phone).

(d) You must tell the employee that if

he or she makes this request within 72

hours, the employer must ensure that

the test takes place, and that the

employee is not required to pay for the

test from his or her own funds before

the test takes place. You must also tell

the employee that the employer may

seek reimbursement for the cost of the

test (see § 40.173 ).

(e) You must tell the employee that

additional tests of the specimen e.g.,

DNA tests) are not authorized.

§ 40.155 What does the MRO do when a

negative or positive test result is also

dilute?

(a) When the laboratory reports that a

specimen is dilute, you must, as the

MRO, report to the DER that the

specimen, in addition to being negative

or positive, is dilute.

(b) You must check the ‘‘dilute’’ box

(Step 6) on Copy 2 of the CCF.

(c) You may only report a dilute test

result when you are in possession of a

legible copy of Copy 1 of the CCF. In

addition, you must have Copy 2 of the

CCF, a legible copy of it, or any other

copy of the CCF containing the

employee’s signature.

(d) When you report a dilute

specimen to the DER, you must explain

to the DER the employer’s obligations

and choices under § 40.197.

§ 40.157 [Reserved]

§ 40.159 What does the MRO do when a

drug test result is invalid?

(a) As the MRO, when the laboratory

reports that the test result is an invalid

result, you must do the following:

(1) Discuss the laboratory results with

a certifying scientist to obtain more

specific information.

(2) Contact the employee and inform

the employee that the specimen was

invalid or contained an unexplained

interfering substance. In contacting the

employee, use the procedures set forth

in § 40.131.

(3) After explaining the limits of

disclosure (see §§ 40.135(d) and 40.327),

you should inquire as to medications

the employee may have taken that may

interfere with some immunoassay tests.

(4) If the employee gives an

explanation that is acceptable, you

must:

(i) Place a check mark in the ‘‘Test

Cancelled’’ box (Step 6) on Copy 2 of

the CCF and enter ‘‘Invalid Result’’ and

‘‘direct observation collection not

required’’ on the ‘‘Remarks’’ line.

(ii) Report to the DER that the test is

cancelled, the reason for cancellation,

and that no further action is required

unless a negative test result is required

(i.e., pre-employment, return-to-duty, or

follow-up tests).

(5) If the employee is unable to

provide an explanation and/or a valid

prescription for a medication that

interfered with the immunoassay test

but denies having adulterated the

specimen, you must:

(i) Place a check mark in the ‘‘Test

Cancelled’’ box (Step 6) on Copy 2 of

the CCF and enter ‘‘Invalid Result’’ and

‘‘direct observation collection required’’

on the ‘‘Remarks’’ line.

(ii) Report to the DER that the test is

cancelled, the reason for cancellation,

and that a second collection must take

place immediately under direct

observation.

(iii) Instruct the employer to ensure

that the employee has the minimum

possible advance notice that he or she

must go to the collection site.

(b) You may only report an invalid

test result when you are in possession

of a legible copy of Copy 1 of the CCF.

In addition, you must have Copy 2 of

the CCF, a legible copy of it, or any

other copy of the CCF containing the

employee’s signature.

(c) If the employee admits to having

adulterated or substituted the specimen,

you must, on the same day, write and

sign your own statement of what the

employee told you. You must then

report a refusal to test in accordance

with § 40.163 .

§ 40.161 What does the MRO do when a

drug test specimen is rejected for testing?

As the MRO, when the laboratory

reports that the specimen is rejected for

testing (e.g., because of a fatal or

uncorrected flaw), you must do the

following:

(a) Place a check mark in the ‘‘Test

Cancelled’’ box (Step 6) on Copy 2 of

the CCF and enter the reason on the

‘‘Remarks’’ line.

(b) Report to the DER that the test is

cancelled and the reason for

cancellation, and that no further action

is required unless a negative test is

required (e.g., in the case of a preemployment, return-to-duty, or followup test).

(c) You may only report a test

cancelled because of a rejected for

testing test result when you are in

possession of a legible copy of Copy 1

of the CCF. In addition, you must have

Copy 2 of the CCF, a legible copy of it,

or any other copy of the CCF containing

the employee’s signature.

§ 40.163 How does the MRO report drug

test results?

(a) As the MRO, it is your

responsibility to report the drug test

results to the employer in writing.

(1) You or a staff member may rubber

stamp a report of negative results. If you

use a rubber stamp, you or your staff

must also initial the stamp to identify

who affixed the stamp to the report.

(2) You, as the MRO, must sign

reports of all other results.

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79549

(b) You may use a signed or stamped

and dated legible photocopy of Copy 2

of the CCF to report test results.

(c) If you do not report test results

using Copy 2 of the CCF for this

purpose, you must provide a written

report (e.g., a letter) for each test result.

This report must, as a minimum,

include the following information:

(1) Full name, as indicated on the

CCF, of the employee tested;

(2) Specimen ID number from the CCF

and the donor SSN or employee ID

number;

(3) Reason for the test as indicated on

the CCF (e.g., random, post-accident);

(4) Date of the collection;

(5) Result of the test (i.e., positive,

negative, dilute, refusal to test, test

cancelled) and the date the result was

verified by the MRO;

(6) For verified positive tests, the

drug(s)/metabolite(s) for which the test

was positive;

(7) For cancelled tests, the reason for

cancellation; and

(8) For refusals to test, the reason for

the refusal determination (e.g., in the

case of an adulterated test result, the

name of the adulterant).

(d) You must retain a signed or

stamped and dated copy of Copy 2 of

the CCF in your records. If you do not

use Copy 2 for reporting results, you

must maintain a copy of the signed or

stamped and dated letter in addition to

the signed or stamped and dated Copy

2.

(e) You must not use Copy 1 of the

CCF to report drug test results.

(f) You must not provide quantitative

values to the DER or C/TPA for drug or

validity test results. However, you must

provide the test information in your

possession to a SAP who consults with

you (see § 40.293(g)).

§ 40.165 To whom does the MRO transmit

reports of drug test results?

(a) As the MRO, you must report all

drug test results to the DER, except in

the circumstances provided for in

§ 40.345 .

(b) If the employer elects to receive

reports of results through a C/TPA,

acting as an intermediary as provided in

§ 40.345 , you must report the results

through the designated C/TPA.

§ 40.167 How are MRO reports of drug

results transmitted to the employer?

As the MRO or C/TPA who transmits

drug test results to the employer, you

must comply with the following

requirements:

(a) You must report the results in a

confidential manner.

(b) You must transmit to the DER on

the same day the MRO verifies the result

or the next business day all verified

positive test results, results requiring an

immediate collection under direct

observation, adulterated or substituted

specimen results, and other refusals to

test.

(1) Direct telephone contact with the

DER is the preferred method of

immediate reporting. Follow up your

phone call with appropriate

documentation (see § 40.163).

(2) You are responsible for identifying

yourself to the DER, and the DER must

have a means to confirm your

identification.

(3) The MRO’s report that you

transmit to the employer must contain

all of the information required by

§ 40.163 .

(c) You must transmit the MRO’s

written report of verified test to the DER

so that the DER receives them within

two days of verification by the MRO.

(d) In transmitting test results, you or

the C/TPA and the employer must

ensure the security of the transmission

and limit access to any transmission,

storage, or retrieval systems.

§ 40.169 Where is other information

concerning the role of MROs and the

verification process found in this

regulation?

You can find more information

concerning the role of MROs in several

sections of this part:

§ 40.3—Definition.

§ § 40.47–40.49—Correction of form and kit

errors.

§ 40.67—Role in direct observation and other

atypical test situations.

§ 40.83—Laboratory handling of fatal and

correctable flaws.

§ 40.97—Laboratory handling of test results

and quantitative values.

§ 40.99—Authorization of longer laboratory

retention of specimens.

§ 40.101—Relationship with laboratories;

avoidance of conflicts of interest.

§ 40.105—Notification of discrepancies in

blind specimen results.

§ 40.171—Request for test of split specimen.

§ 40.187—Action concerning split specimen

test results.

§ 40.193—Role in ‘‘shy bladder’’ situations.

§ 40.195—Role in cancelling tests.

§§ 40.199–40.203—Documenting errors in

tests.

§ 40.327—Confidentiality and release of

information.

§ 40.347—Transfer of records.

§ 40.353—Relationships with service agents.

Subpart H—Split Specimen Tests

§ 40.171 How does an employee request a

test of a split specimen?

(a) As an employee, when the MRO

has notified you that you have a verified

positive drug test or refusal to test

because of adulteration or substitution,

you have 72 hours from the time of

notification to request a test of the split

specimen. The request may be verbal or

in writing. If you make this request to

the MRO within 72 hours, you trigger

the requirements of this section for a

test of the split specimen.

(b)(1) If, as an employee, you have not

requested a test of the split specimen

within 72 hours, you may present to the

MRO information documenting that

serious injury, illness, lack of actual

notice of the verified test result,

inability to contact the MRO (e.g., there

was no one in the MRO’s office and the

answering machine was not working), or

other circumstances unavoidably

prevented you from making a timely

request.

(2) As the MRO, if you conclude from

the employee’s information that there

was a legitimate reason for the

employee’s failure to contact you within

72 hours, you must direct that the test

of the split specimen take place, just as

you would when there is a timely

request.

(c) When the employee makes a

timely request for a test of the split

specimen under paragraphs (a) and (b)

of this section, you must, as the MRO,

immediately provide written notice to

the laboratory that tested the primary

specimen, directing the laboratory to

forward the split specimen to a second

HHS-certified laboratory. You must also

document the date and time of the

employee’s request.

§ 40.173 Who is responsible for paying for

the test of a split specimen?

(a) As the employer, you are

responsible for making sure (e.g., by

establishing appropriate accounts with

laboratories for testing split specimens)

that the MRO, first laboratory, and

second laboratory perform the functions

noted in §§ 40.175–40.185 in a timely

manner, once the employee has made a

timely request for a test of the split

specimen.

(b) As the employer, you must not

condition your compliance with these

requirements on the employee’s direct

payment to the MRO or laboratory or the

employee’s agreement to reimburse you

for the costs of testing. For example, if

you ask the employee to pay for some

or all of the cost of testing the split

specimen, and the employee is

unwilling or unable to do so, you must

ensure that the test takes place in a

timely manner, even though this means

that you pay for it.

(c) As the employer, you may seek

payment or reimbursement of all or part

of the cost of the split specimen from

the employee (e.g., through your written

company policy or a collective

bargaining agreement). This part takes

79550 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

no position on who ultimately pays the

cost of the test, so long as the employer

ensures that the testing is conducted as

required and the results released

appropriately.

§ 40.175 What steps does the first

laboratory take with a split specimen?

(a) As the laboratory at which the

primary and split specimen first arrive,

you must check to see whether the split

specimen is available for testing.

(b) If the split specimen is unavailable

or appears insufficient, you must then

do the following:

(1) Continue the testing process for

the primary specimen as you would

normally. Report the results for the

primary specimen without providing

the MRO information regarding the

unavailable split specimen.

(2) Upon receiving a letter from the

MRO instructing you to forward the

split specimen to another laboratory for

testing, report to the MRO that the split

specimen is unavailable for testing.

Provide as much information as you can

about the cause of the unavailability.

(c) As the laboratory that tested the

primary specimen, you are not

authorized to open the split specimen

under any circumstances (except when

the split specimen is redesignated as

provided in § 40.83).

(d) When you receive written notice

from the MRO instructing you to send

the split specimen to another HHScertified laboratory, you must forward

the following items to the second

laboratory:

(1) The split specimen in its original

specimen bottle, with the seal intact;

(2) A copy of the MRO’s written

request; and

(3) A copy of Copy 1 of the CCF,

which identifies the drug(s)/

metabolite(s) or the validity criteria to

be tested for.

(e) You must not send to the second

laboratory any information about the

identity of the employee. Inadvertent

disclosure does not, however, cause a

fatal flaw.

(f) This subpart does not prescribe

who gets to decide which HHS-certified

laboratory is used to test the split

specimen. That decision is left to the

parties involved.

§ 40.177 What does the second laboratory

do with the split specimen when it is tested

to reconfirm the presence of a drug or drug

metabolite?

(a) As the laboratory testing the split

specimen, you must test the split

specimen for the drug(s)/drug

metabolite(s) detected in the primary

specimen.

(b) You must conduct this test

without regard to the cutoff

concentrations of § 40.87 .

(c) If the test fails to reconfirm the

presence of the drug(s)/drug

metabolite(s) that were reported positive

in the primary specimen, you must

conduct validity tests in an attempt to

determine the reason for being unable to

reconfirm the presence of the drug(s)/

metabolite(s). You should conduct the

same validity tests as you would

conduct on a primary specimen set forth

in § 40.91 .

(d) In addition, if the test fails to

reconfirm the presence of the drugs/

drugs metabolites or validity criteria

that were reported in the primary

specimen, you may transmit the

specimen or an aliquot of it to another

HHS-certified laboratory that will

conduct another reconfirmation test.

§ 40.179 What does the second laboratory

do with the split specimen when it is tested

to reconfirm an adulterated test result?

As the laboratory testing the split

specimen, you must test the split

specimen for the adulterant detected in

the primary specimen, using the criteria

of § 40.95 just as you would do for a

primary specimen. The result of the

primary specimen is reconfirmed if the

split specimen meets these criteria.

§ 40.181 What does the second laboratory

do with the split specimen when it is tested

to reconfirm a substituted test result?

As the laboratory testing the split

specimen, you must test the split

specimen using the criteria of § 40.93(b),

just as you would do for a primary

specimen. The result of the primary

specimen is reconfirmed if the split

specimen meets these criteria.

§ 40.183 What information do laboratories

report to MROs regarding split specimen

results?

(a) As the laboratory responsible for

testing the split specimen, you must

report split specimen test results by

checking the ‘‘Reconfirmed’’ box or the

‘‘Failed to Reconfirm’’ box (Step 5(b)) on

Copy 1 of the CCF.

(b) If you check the ‘‘Failed to

Reconfirm’’ box, one of the following

statements must be included (as

appropriate) on the ‘‘Reason’’ line (Step

5(b)):

(1) ‘‘Drug(s)/Drug Metabolite(s) Not

Detected.’’

(2) ‘‘Adulterant not found within

criteria.’’

(3) ‘‘Specimen not consistent with

substitution criteria [specify creatinine,

specific gravity, or both]’’

(4) ‘‘Specimen not available for

testing.’’

(c) As the laboratory certifying

scientist, enter your name, sign, and

date the CCF.

§ 40.185 Through what methods and to

whom must a laboratory report split

specimen results?

(a) As the laboratory testing the split

specimen, you must report laboratory

results directly, and only, to the MRO at

his or her place of business. You must

not report results to or through the DER

or another service agent (e.g., a C/TPA).

(b) You must fax, courier, mail, or

electronically transmit a legible image

or copy of the fully-completed Copy 1

of the CCF, which has been signed by

the certifying scientist.

(c) You must transmit the laboratory

result to the MRO immediately,

preferably on the same day or next

business day as the result is signed and

released.

§ 40.187 What does the MRO do with split

specimen laboratory results?

As an MRO, you must take the

following actions when a laboratory

reports the following results of split

specimen tests:

(a) Reconfirmed. (1) In the case of a

reconfirmed positive test for a drug or

drug metabolite, report the

reconfirmation to the DER and the

employee.

(2) In the case of a reconfirmed

adulterated or substituted result, report

to the DER and the employee that the

specimen was adulterated or

substituted, either of which constitutes

a refusal to test. Therefore, ‘‘refusal to

test’’ is the final result.

(b) Failed to Reconfirm: Drug(s)/Drug

Metabolite(s) Not Detected. (1) Report to

the DER and the employee that both

tests must be cancelled.

(2) Using the format in Appendix D to

this part, inform ODAPC of the failure

to reconfirm.

(c) Failed to Reconfirm: Adulteration

or Substitution (as appropriate) Criteria

Not Met. (1) Report to the DER and the

employee that both tests must be

cancelled.

(2) Using the format in Appendix D to

this part, inform ODAPC of the failure

to reconfirm.

(d) Failed to Reconfirm: Specimen not

Available for Testing. (1) Report to the

DER and the employee that both tests

must be cancelled and the reason for

cancellation.

(2) Direct the DER to ensure the

immediate collection of another

specimen from the employee under

direct observation, with no notice given

to the employee of this collection

requirement until immediately before

the collection.

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79551

(3) Using the format in Appendix D to

this part, notify ODAPC of the failure to

reconfirm.

(e) Enter your name, sign and date

(Step 7) of Copy 2 of the CCF.

(f) Send a legible copy of Copy 2 of

the CCF (or a signed and dated letter,

see § 40.163 ) to the employer and keep

a copy for your records. Transmit the

document as provided in § 40.167.

§ 40.189 Where is other information

concerning split specimens found in this

regulation?

You can find more information

concerning split specimens in several

sections of this part:

§ 40.3—Definition.

§ 40.65—Quantity of split specimen.

§ 40.67—Directly observed test when split

specimen is unavailable.

§§ 40.71–40.73—Collection process for split

specimens.

§ 40.83—Laboratory accessioning of split

specimens.

§ 40.99—Laboratory retention of split

specimens.

§ 40.103—Blind split specimens.

§ 40.153—MRO notice to employees on tests

of split specimen.

§§ 40.193 and 40.201—MRO actions on

insufficient or unavailable split

specimens.

Appendix D to Part 40—Report format for

split specimen failure to reconfirm.

Subpart I—Problems in Drug Tests

§ 40.191 What is a refusal to take a DOT

drug test, and what are the consequences?

(a) As an employee, you have refused

to take a drug test if you:

(1) Fail to appear for any test within

a reasonable time, as determined by the

employer, after being directed to do so

by the employer. This includes the

failure of an employee (including an

owner-operator) to appear for a test

when called by C/TPA (see § 40.61(a));

(2) Fail to remain at the testing site

until the testing process is complete;

(3) Fail to provide a urine specimen

for any drug test required by this part

or DOT agency regulations;

(4) In the case of a directly observed

or monitored collection in a drug test,

fail to permit the observation or

monitoring of your provision of a

specimen (see §§ 40.67(l) and 40.69(g));

(5) Fail to provide a sufficient amount

of urine when directed, and it has been

determined, through a required medical

evaluation, that there was no adequate

medical explanation for the failure (see

§ 40.193(d)(2));

(6) Fail or decline to take a second test

the employer or collector has directed

you to take;

(7) Fail to undergo a medical

examination or evaluation, as directed

by the MRO as part of the verification

process, or as directed by the DER as

part of the ‘‘shy bladder’’ procedures of

this part (see § 40.193(d)); or

(8) Fail to cooperate with any part of

the testing process (e.g., refuse to empty

pockets when so directed by the

collector, behave in a confrontational

way that disrupts the collection

process).

(b) As an employee, if the MRO

reports that you have a verified

adulterated or substituted test result,

you have refused to take a drug test.

(c) As an employee, if you refuse to

take a drug test, you incur the

consequences specified under DOT

agency regulations for a violation of

those DOT agency regulations.

(d) As a collector or an MRO, when

an employee refuses to participate in the

part of the testing process in which you

are involved, you must terminate the

portion of the testing process in which

you are involved, document the refusal

on the CCF (or in a separate document

which you cause to be attached to the

form), immediately notify the DER by

any means (e.g., telephone or secure fax

machine) that ensures that the refusal

notification is immediately received. As

a referral physician (e.g., physician

evaluating a ‘‘shy bladder’’ condition or

a claim of a legitimate medical

explanation in a validity testing

situation), you must notify the MRO,

who in turn will notify the DER.

(1) As the collector, you must note the

refusal in the ‘‘Remarks’’ line (Step 2),

and sign and date the CCF.

(2) As the MRO, you must note the

refusal by checking the ‘‘refused to test

because’’ box (Step 6) on Copy 2 of the

CCF, and add the reason on the

‘‘Remarks’’ line. You must then sign and

date the CCF.

(e) As an employee, when you refuse

to take a non-DOT test or to sign a nonDOT form, you have not refused to take

a DOT test. There are no consequences

under DOT agency regulations for

refusing to take a non-DOT test.

§ 40.193 What happens when an employee

does not provide a sufficient amount of

urine for a drug test?

(a) This section prescribes procedures

for situations in which an employee

does not provide a sufficient amount of

urine to permit a drug test (i.e., 45 mL

of urine).

(b) As the collector, you must do the

following:

(1) Discard the insufficient specimen,

except where the insufficient specimen

was out of temperature range or showed

evidence of adulteration or tampering

(see § 40.65(b) and (c)).

(2) Urge the employee to drink up to

40 ounces of fluid, distributed

reasonably through a period of up to

three hours, or until the individual has

provided a sufficient urine specimen,

whichever occurs first. It is not a refusal

to test if the employee declines to drink.

(3) If the employee refuses to make

the attempt to provide a new urine

specimen, you must discontinue the

collection, note the fact on the

‘‘Remarks’’ line of the CCF (Step 2), and

immediately notify the DER. This is a

refusal to test.

(4) If the employee has not provided

a sufficient specimen within three hours

of the first unsuccessful attempt to

provide the specimen, you must

discontinue the collection, note the fact

on the ‘‘Remarks’’ line of the CCF (Step

2), and immediately notify the DER.

(5) Send Copy 2 of the CCF to the

MRO and Copy 4 to the DER. You must

send or fax these copies to the MRO and

DER within 24 hours or the next

business day.

(c) As the DER, when the collector

informs you that the employee has not

provided a sufficient amount of urine

(see paragraph (b)(4) of this section),

you must, after consulting with the

MRO, direct the employee to obtain,

within five working days, an evaluation

from a licensed physician, acceptable to

the MRO, who has expertise in the

medical issues raised by the employee’s

failure to provide a sufficient specimen.

(The MRO may perform this evaluation

if the MRO has appropriate expertise.)

(1) As the MRO, if another physician

will perform the evaluation, you must

provide the other physician with the

following information and instructions:

(i) That the employee was required to

take a DOT drug test, but was unable to

provide a sufficient amount of urine to

complete the test;

(ii) The consequences of the

appropriate DOT agency regulation for

refusing to take the required drug test;

(iii) That the referral physician must

agree to follow the requirements of

paragraphs (d) through (g) of this

section.

(d) As the referral physician

conducting this evaluation, you must

recommend that the MRO make one of

the following determinations:

(1) A medical condition has, or with

a high degree of probability could have,

precluded the employee from providing

a sufficient amount of urine. As the

MRO, if you accept this

recommendation, you must:

(i) Check ‘‘Test Cancelled’’ (Step 6) on

the CCF; and

(ii) Sign and date the CCF.

(2) There is not an adequate basis for

determining that a medical condition

has, or with a high degree of probability

could have, precluded the employee

79552 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

from providing a sufficient amount of

urine. As the MRO, if you accept this

recommendation, you must:

(i) Check ‘‘Refusal to test because’’

(Step 6) on the CCF and enter reason in

the remarks line; and

(ii) Sign and date the CCF.

(e) For purposes of this paragraph, a

medical condition includes an

ascertainable physiological condition

(e.g., a urinary system dysfunction) or a

medically documented pre-existing

psychological disorder, but does not

include unsupported assertions of

‘‘situational anxiety’’ or dehydration.

(f) As the referral physician making

the evaluation, after completing your

evaluation, you must provide a written

statement of your recommendations and

the basis for them to the MRO. You

must not include in this statement

detailed information on the employee’s

medical condition beyond what is

necessary to explain your conclusion.

(g) If, as the referral physician making

this evaluation in the case of a preemployment test, you determine that the

employee’s medical condition is a

serious and permanent or long-term

disability that is highly likely to prevent

the employee from providing a

sufficient amount of urine for a very

long or indefinite period of time, you

must set forth your determination and

the reasons for it in your written

statement to the MRO. As the MRO,

upon receiving such a report, you must

follow the requirements of § 40.195,

where applicable.

(h) As the MRO, you must seriously

consider and assess the referral

physician’s recommendations in making

your determination about whether the

employee has a medical condition that

has, or with a high degree of probability

could have, precluded the employee

from providing a sufficient amount of

urine. You must report your

determination to the DER in writing as

soon as you make it.

(i) As the employer, when you receive

a report from the MRO indicating that

a test is cancelled as provided in

paragraph (d)(1) of this section, you take

no further action with respect to the

employee. The employee remains in the

random testing pool.

§ 40.195 What happens when an individual

is unable to provide a sufficient amount of

urine for a pre-employment or return-toduty test because of a permanent or longterm medical condition?

(a) This section concerns a situation

in which an employee has a medical

condition that precludes him or her

from providing a sufficient specimen for

a pre-employment or return-to-duty test

and the condition involves a permanent

or long-term disability. As the MRO in

this situation, you must do the

following:

(1) You must determine if there is

clinical evidence that the individual is

an illicit drug user. You must make this

determination by personally

conducting, or causing to be conducted,

a medical evaluation and through

consultation with the employee’s

physician and/or the physician who

conducted the evaluation under

§ 40.193(d).

(2) If you do not personally conduct

the medical evaluation, you must ensure

that one is conducted by a licensed

physician acceptable to you.

(3) For purposes of this section, the

MRO or the physician conducting the

evaluation may conduct an alternative

test (e.g., blood) as part of the medically

appropriate procedures in determining

clinical evidence of drug use.

(b) If the medical evaluation reveals

no clinical evidence of drug use, as the

MRO, you must report the result to the

employer as a negative test with written

notations regarding results of both the

evaluation conducted under § 40.193(d)

and any further medical examination.

This report must state the basis for the

determination that a permanent or longterm medical condition exists, making

provision of a sufficient urine specimen

impossible, and for the determination

that no signs and symptoms of drug use

exist.

(1) Check ‘‘Negative’’ (Step 6) on the

CCF.

(2) Sign and date the CCF.

(c) If the medical evaluation reveals

clinical evidence of drug use, as the

MRO, you must report the result to the

employer as a cancelled test with

written notations regarding results of

both the evaluation conducted under

§ 40.193(d) and any further medical

examination. This report must state that

a permanent or long-term medical

condition exists, making provision of a

sufficient urine specimen impossible,

and state the reason for the

determination that signs and symptoms

of drug use exist. Because this is a

cancelled test, it does not serve the

purposes of a negative test (i.e., the

employer is not authorized to allow the

employee to begin or resume performing

safety-sensitive functions, because a

negative test is needed for that purpose).

(d) For purposes of this section,

permanent or long-term medical

conditions are those physiological,

anatomic, or psychological

abnormalities documented as being

present prior to the attempted

collection, and considered not amenable

to correction or cure for an extended

period of time, if ever.

(1) Examples would include

destruction (any cause) of the

glomerular filtration system leading to

renal failure; unrepaired traumatic

disruption of the urinary tract; or a

severe psychiatric disorder focused on

genito-urinary matters.

(2) Acute or temporary medical

conditions, such as cystitis, urethritis or

prostatitis, though they might interfere

with collection for a limited period of

time, cannot receive the same

exceptional consideration as the

permanent or long-term conditions

discussed in paragraph (d)(1) of this

section.

§ 40.197 What happens when an employer

receives a report of a dilute specimen?

(a) As the employer, if the MRO

informs you that a positive drug test was

dilute, you simply treat the test as a

verified positive test. You must not

direct the employee to take another test

based on the fact that the specimen was

dilute.

(b) If the MRO informs you that a

negative drug test was dilute, you may,

but are not required to, direct the

employee to take another test

immediately. Such recollections must

not be collected under direct

observation, unless there is another

basis for use of direct observation (see

§ 40.67(b) and (c)).

(c) You must treat all employees the

same for this purpose. For example, you

must not retest some employees and not

others. You may, however, establish

different policies for different types of

tests (e.g., conduct retests in preemployment test situations, but not in

random test situations). You must

inform your employees in advance of

your decisions on these matters.

(d) If you direct the employee to take

another test, you must ensure that the

employee is given the minimum

possible advance notice that he or she

must go to the collection site.

(e) If you direct the employee to take

another test, the result of the second

test—not that of the original test—

becomes the test of record, on which

you rely for purposes of this part.

(f) If you require employees to take

another test, and the second test is also

negative and dilute, you are not

permitted to make the employee take a

third test because the second test was

dilute.

(g) If you direct the employee to take

another test and the employee declines

to do so, the employee has refused the

test for purpose of this part and DOT

agency regulations.

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79553

§ 40.199 What problems always cause a

drug test to be cancelled?

(a) As the MRO, when the laboratory

discovers a ‘‘fatal flaw’’ during its

processing of incoming specimens (see

§ 40.83), the laboratory will report to

you that the specimen has been

‘‘Rejected for Testing’’ (with the reason

stated). You must always cancel such a

test.

(b) The following are ‘‘fatal flaws’’:

(1) There is no printed collector’s

name and no collector’s signature;

(2) The specimen ID numbers on the

specimen bottle and the CCF do not

match;

(3) The specimen bottle seal is broken

or shows evidence of tampering (and a

split specimen cannot be redesignated,

see § 40.83(g)); and

(4) Because of leakage or other causes,

there is an insufficient amount of urine

in the primary specimen bottle for

analysis and the specimens cannot be

redesignated (see § 40.83(g)).

(c) You must report the result as

provided in § 40.161 .

§ 40.201 What problems always cause a

drug test to be cancelled and may result in

a requirement for another collection?

As the MRO, you must cancel a drug

test when a laboratory reports that any

of the following problems have

occurred. You must inform the DER that

the test was cancelled. You must also

direct the DER to ensure that an

additional collection occurs

immediately, if required by the

applicable procedures specified in

paragraphs (a) through (e) of this

section.

(a) The laboratory reports an ‘‘Invalid

Result.’’ You must follow applicable

procedures in § 40.159 (recollection

under direct observation may be

required).

(b) The laboratory reports the result as

‘‘Rejected for Testing.’’ You must follow

applicable procedures in § 40.161 (a

recollection may be required).

(c) The laboratory’s test of the primary

specimen is positive and the split

specimen is reported by the laboratory

as ‘‘Failure to Reconfirm: Drug(s)/Drug

Metabolite(s) Not Detected.’’ You must

follow applicable procedures in

§ 40.187(b) (no recollection is required

in this case).

(d) The laboratory’s test result for the

primary specimen is adulterated or

substituted and the split specimen is

reported by the laboratory as

‘‘Adulterant not found within criteria,’’

or ‘‘ specimen not consistent with

substitution criteria, as applicable. You

must follow applicable procedures in

§ 40.187(c) (no recollection is required

in this case).

(e) The laboratory’s test of the primary

specimen is positive, adulterated, or

substituted and the split specimen is

unavailable for testing. You must follow

applicable procedures in § 40.187(d)

(recollection under direct observation is

required in this case).

(f) The examining physician has

determined that there is an acceptable

medical explanation of the employee’s

failure to provide a sufficient amount of

urine. You must follow applicable

procedures in § 40.193(d)(1) (no

recollection is required in this case).

§ 40.203 What problems cause a drug

test to be cancelled unless they are

corrected?

(a) As the MRO, when a laboratory

discovers a ‘‘correctable flaw’’ during its

processing of incoming specimens (see

§ 40.83), the laboratory will attempt to

correct it. If the laboratory is

unsuccessful in this attempt, it will

report to you that the specimen has been

‘‘Rejected for Testing’’ (with the reason

stated).

(b) The following are ‘‘correctable

flaws’’ that laboratories must attempt to

correct:

(1) The collector’s signature is omitted

on the certification statement on the

CCF.

(2) The specimen temperature was not

checked and the ‘‘Remarks’’ line did not

contain an entry regarding the

temperature being out of range.

(c) As the MRO, when you discover a

‘‘correctable flaw’’ during your review

of the CCF, you must cancel the test

unless the flaw is corrected.

(d) The following are correctable

flaws that you must attempt to correct:

(1) The employee’s signature is

omitted from the certification statement,

unless the employee’s failure or refusal

to sign is noted on the ‘‘Remarks’’ line

of the CCF.

(2) The certifying scientist’s signature

is omitted on the laboratory copy of the

CCF for a positive, adulterated,

substituted, or invalid test result.

(3) The collector uses a non-DOT form

for the test, provided that the collection

and testing process is conducted in

accordance with DOT procedures in an

HHS-certified laboratory following DOT

initial and confirmation test criteria.

§ 40.205 How are drug test problems

corrected?

(a) As a collector, you have the

responsibility of trying to successfully

complete a collection procedure for

each employee.

(1) If, during or shortly after the

collection process, you become aware of

any event that prevents the completion

of a valid test or collection (e.g., a

procedural or paperwork error), you

must try to correct the problem

promptly, if doing so is practicable. You

may conduct another collection as part

of this effort.

(2) If another collection is necessary,

you must begin the new collection

procedure as soon as possible, using a

new CCF and a new collection kit.

(b) If, as a collector, laboratory, MRO,

employer, or other person implementing

these drug testing regulations, you

become aware of a problem that can be

corrected (see § 40.203 ), but which has

not already been corrected under

paragraph (a) of this section, you must

take all practicable action to correct the

problem so that the test is not cancelled.

(1) If the problem resulted from the

omission of required information, you

must, as the person responsible for

providing that information, supply in

writing the missing information and a

statement that it is true and accurate.

For example, suppose you are a

collector, and you forgot to make a

notation on the ‘‘Remarks’’ line of the

CCF that the employee did not sign the

certification. You would, when the

problem is called to your attention,

supply a signed statement that the

employee failed or refused to sign the

certification and that your statement is

true and accurate. You must supply this

information on the same business day

on which you are notified of the

problem, transmitting it by fax or

courier.

(2) If the problem is the use of a nonFederal form, you must, as the person

responsible for the use of the incorrect

form, provide a signed statement that

the incorrect form contains all the

information needed for a valid DOT

drug test, that the incorrect form was

used inadvertently or as the only means

of conducting a test, in circumstances

beyond your control. The statement

must also list the steps you have taken

to prevent future use of non-Federal

forms for DOT tests. For this flaw to

have been corrected, the test of the

specimen must have occurred at a HHScertified laboratory where it was tested

using the testing protocol in this part.

You must supply this information on

the same business day on which you are

notified of the problem, transmitting it

by fax or courier.

(3) You must maintain the written

documentation of a correction with the

CCF.

(4) You must mark the CCF in such a

way (e.g., stamp noting correction) as to

make it obvious on the face of the CCF

that you corrected the flaw.

(c) If the correction does not take

place, as the MRO you must cancel the

test.

79554 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

§ 40.207 What is the effect of a cancelled

drug test?

(a) A cancelled drug test is neither

positive nor negative.

(1) As an employer, you must not

attach to a cancelled test the

consequences of a positive test or other

violation of a DOT drug testing

regulation (e.g., removal from a safetysensitive position).

(2) As an employer, you must not use

a cancelled test for the purposes of a

negative test to authorize the employee

to perform safety-sensitive functions

(i.e., in the case of a pre-employment,

return-to-duty, or follow-up test).

(3) However, as an employer, you

must not direct a recollection for an

employee because a test has been

cancelled, except in the situations cited

in paragraph (a)(2) of this section or

other provisions of this part that require

another test to be conducted (e.g.,

§§ 40.159(a)(5) and 40.187(b)).

(b) A cancelled test does not count

toward compliance with DOT

requirements (e.g., being applied toward

the number of tests needed to meet the

employer’s minimum random testing

rate).

(c) A cancelled DOT test does not

provide a valid basis for an employer to

conduct a non-DOT test (i.e., a test

under company authority).

§ 40.209 What is the effect of procedural

problems that are not sufficient to cancel a

drug test?

(a) As a collector, laboratory, MRO,

employer or other person administering

the drug testing process, you must

document any errors in the testing

process of which you become aware,

even if they are not considered

problems that will cause a test to be

cancelled as listed in this subpart.

Decisions about the ultimate impact of

these errors will be determined by other

administrative or legal proceedings,

subject to the limitations of paragraph

(b) of this section.

(b) No person concerned with the

testing process may declare a test

cancelled based on an error that does

not have a significant adverse effect on

the right of the employee to have a fair

and accurate test. Matters that do not

result in the cancellation of a test

include, but are not limited to, the

following:

(1) A minor administrative mistake

(e.g., the omission of the employee’s

middle initial, a transposition of

numbers in the employee’s social

security number);

(2) An error that does not affect

employee protections under this part

(e.g., the collector’s failure to add bluing

agent to the toilet bowl, which adversely

affects only the ability of the collector

to detect tampering with the specimen

by the employee);

(3) The collection of a specimen by a

collector who is required to have been

trained (see § 40.33), but who has not

met this requirement;

(4) A delay in the collection process

(see § 40.61(a));

(5) Verification of a test result by an

MRO who has the basic credentials to be

qualified as an MRO (see § 40.121(a)

through (b)) but who has not met

training and/or documentation

requirements (see § 40.121(c) through

(e));

(6) The failure to directly observe or

monitor a collection that the rule

requires or permits to be directly

observed or monitored, or the

unauthorized use of direct observation

or monitoring for a collection;

(7) The fact that a test was conducted

in a facility that does not meet the

requirements of § 40.41;

(8) If the specific name of the courier

on the CCF is omitted or erroneous;

(9) Personal identifying information is

inadvertently contained on the CCF

(e.g., the employee signs his or her name

on the laboratory copy); or

(10) Claims that the employee was

improperly selected for testing.

(c) As an employer, these types of

errors, even though not sufficient to

cancel a drug test result, may subject

you to enforcement action under DOT

agency regulations.

Subpart J—Alcohol Testing Personnel

§ 40.211 Who conducts DOT alcohol

tests?

(a) Screening test technicians (STTs)

and breath alcohol technicians (BATs)

meeting their respective requirements of

this subpart are the only people

authorized to conduct DOT alcohol

tests.

(b) An STT can conduct only alcohol

screening tests, but a BAT can conduct

alcohol screening and confirmation

tests.

(c) As a BAT- or STT-qualified

immediate supervisor of a particular

employee, you may not act as the STT

or BAT when that employee is tested,

unless no other STT or BAT is available

and DOT agency regulations do not

prohibit you from doing so.

§ 40.213 What training requirements must

STTs and BATs meet?

To be permitted to act as a BAT or

STT in the DOT alcohol testing

program, you must meet each of the

requirements of this section:

(a) Basic information. You must be

knowledgeable about the alcohol testing

procedures in this part and the current

DOT guidance. These documents and

information are available from ODAPC

(Department of Transportation, 400 7th

Street, SW., Room 10403, Washington

DC, 20590, 202–366–3784, or on the

ODAPC web site, http://www.dot.gov/

ost/dapc)).

(b) Qualification training. You must

receive qualification training meeting

the requirements of this paragraph (b).

(1) Qualification training must be in

accordance with the DOT Model BAT or

STT Course, as applicable. The DOT

Model Courses are available from

ODAPC (Department of Transportation,

400 7th Street, SW., Room 10403,

Washington DC, 20590, 202–366–3784,

or on the ODAPC web site, http://

www.dot.gov/ost/dapc). The training

can also be provided using a course of

instruction equivalent to the DOT

Model Courses. On request, ODAPC will

review BAT and STT instruction

courses for equivalency.

(2) Qualification training must

include training to proficiency in using

the alcohol testing procedures of this

part and in the operation of the

particular alcohol testing device(s) (i.e.,

the ASD(s) or EBT(s)) you will be using.

(3) The training must emphasize that

you are responsible for maintaining the

integrity of the testing process, ensuring

the privacy of employees being tested,

and avoiding conduct or statements that

could be viewed as offensive or

inappropriate.

(4) The instructor must be an

individual who has demonstrated

necessary knowledge, skills, and

abilities by regularly conducting DOT

alcohol tests as an STT or BAT, as

applicable, for a period of at least a year,

who has conducted STT or BAT

training, as applicable, under this part

for a year, or who has successfully

completed a ‘‘train the trainer’’ course.

(c) Initial Proficiency Demonstration.

Following your completion of

qualification training under paragraph

(b) of this section, you must

demonstrate proficiency in alcohol

testing under this part by completing

three consecutive error-free mock tests.

(1) Another person must monitor and

evaluate your performance, in person or

by a means that provides real-time

observation and interaction between the

instructor and trainee, and attest in

writing that the mock collections are

‘‘error-free.’’ This person must be an

individual who meets the requirements

of paragraph (b)(4) of this section.

(2) These tests must use the alcohol

testing devices (e.g., EBT(s) or ASD(s))

that you will use as a BAT or STT.

(3) If you are an STT who will be

using an ASD that indicates readings by

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changes, contrasts, or other readings in

color, you must demonstrate as part of

the mock test that you are able to

discern changes, contrasts, or readings

correctly.

(d) Schedule for qualification training

and initial proficiency demonstration.

The following is the schedule for

qualification training and the initial

proficiency demonstration you must

meet:

(1) If you became a BAT or STT before

August 1, 2001, you were required to

have met the requirements set forth in

paragraphs (b) and (c) of this section,

and you do not have to meet them again.

(2) If you become a BAT or STT on

or after August 1, 2001, you must meet

the requirements of paragraphs (b) and

(c) of this section before you begin to

perform BAT or STT functions.

(e) Refresher training. No less

frequently than every five years from the

date on which you satisfactorily

complete the requirements of

paragraphs (b) and (c) of this section,

you must complete refresher training

that meets all the requirements of

paragraphs (b) and (c) of this section.

(f) Error Correction Training. If you

make a mistake in the alcohol testing

process that causes a test to be cancelled

(i.e., a fatal or uncorrected flaw), you

must undergo error correction training.

This training must occur within 30 days

of the date you are notified of the error

that led to the need for retraining.

(1) Error correction training must be

provided and your proficiency

documented in writing by a person who

meets the requirements of paragraph

(b)(4) of this section.

(2) Error correction training is

required to cover only the subject matter

area(s) in which the error that caused

the test to be cancelled occurred.

(3) As part of the error correction

training, you must demonstrate your

proficiency in the alcohol testing

procedures of this part by completing

three consecutive error-free mock tests.

The mock tests must include one

uneventful scenario and two scenarios

related to the area(s) in which your

error(s) occurred. The person providing

the training must monitor and evaluate

your performance and attest in writing

that the mock tests were error-free.

(g) Documentation. You must

maintain documentation showing that

you currently meet all requirements of

this section. You must provide this

documentation on request to DOT

agency representatives and to employers

and C/TPAs who are negotiating to use

your services.

(h) Other persons who may serve as

BATs or STTs. (1) Anyone meeting the

requirements of this section to be a BAT

may act as an STT, provided that the

individual has demonstrated initial

proficiency in the operation of the ASD

that he or she is using, as provided in

paragraph (c) of this section.

(2) Law enforcement officers who

have been certified by state or local

governments to conduct breath alcohol

testing are deemed to be qualified as

BATs. They are not required to also

complete the training requirements of

this section in order to act as BATs. In

order for a test conducted by such an

officer to be accepted under DOT

alcohol testing requirements, the officer

must have been certified by a state or

local government to use the EBT or ASD

that was used for the test.

§ 40.215 What information about the DER

do employers have to provide to BATs and

STTs?

As an employer, you must provide to

the STTs and BATs the name and

telephone number of the appropriate

DER (and C/TPA, where applicable) to

contact about any problems or issues

that may arise during the testing

process.

§ 40.217 Where is other information on the

role of STTs and BATs found in this

regulation?

You can find other information on the

role and functions of STTs and BATs in

the following sections of this part:

§ 40.3—Definitions.

§ 40.223—Responsibility for supervising

employees being tested.

§§ 40.225–40.227—Use of the alcohol testing

form.

§§ 40.241–40.245—Screening test procedures

with ASDs and EBTs.

§§ 40.251–40.255—Confirmation test

procedures.

§ 40.261—Refusals to test.

§§ 40.263–40.265—Insufficient saliva or

breath.

§ 40.267—Problems requiring cancellation of

tests.

§§ 40.269–40.271—Correcting problems in

tests.

Subpart K—Testing Sites, Forms,

Equipment and Supplies Used in

Alcohol Testing

§ 40.221 Where does an alcohol test take

place?

(a) A DOT alcohol test must take place

at an alcohol testing site meeting the

requirements of this section.

(b) If you are operating an alcohol

testing site, you must ensure that it

meets the security requirements of

§ 40.223.

(c) If you are operating an alcohol

testing site, you must ensure that it

provides visual and aural privacy to the

employee being tested, sufficient to

prevent unauthorized persons from

seeing or hearing test results.

(d) If you are operating an alcohol

testing site, you must ensure that it has

all needed personnel, materials,

equipment, and facilities to provide for

the collection and analysis of breath

and/or saliva samples, and a suitable

clean surface for writing.

(e) If an alcohol testing site fully

meeting all the visual and aural privacy

requirements of paragraph (c) is not

readily available, this part allows a

reasonable suspicion or post-accident

test to be conducted at a site that

partially meets these requirements. In

this case, the site must afford visual and

aural privacy to the employee to the

greatest extent practicable.

(f) An alcohol testing site can be in a

medical facility, a mobile facility (e.g.,

a van), a dedicated collection facility, or

any other location meeting the

requirements of this section.

§ 40.223 What steps must be taken to

protect the security of alcohol testing sites?

(a) If you are a BAT, STT, or other

person operating an alcohol testing site,

you must prevent unauthorized

personnel from entering the testing site.

(1) The only people you are to treat

as authorized persons are employees

being tested, BATs, STTs, and other

alcohol testing site workers, DERs,

employee representatives authorized by

the employer (e.g., on the basis of

employer policy or labor-management

agreement), and DOT agency

representatives.

(2) You must ensure that all persons

are under the supervision of a BAT or

STT at all times when permitted into

the site.

(3) You may remove any person who

obstructs, interferes with, or causes

unnecessary delay in the testing

process.

(b) As the BAT or STT, you must not

allow any person other than you, the

employee, or a DOT agency

representative to actually witness the

testing process (see §§ 40.241–40.255).

(c) If you are operating an alcohol

testing site, you must ensure that when

an EBT or ASD is not being used for

testing, you store it in a secure place.

(d) If you are operating an alcohol

testing site, you must ensure that no one

other than BATs or other employees of

the site have access to the site when an

EBT is unsecured.

(e) As a BAT or STT, to avoid

distraction that could compromise

security, you are limited to conducting

an alcohol test for only one employee at

a time.

(1) When an EBT screening test on an

employee indicates an alcohol

79556 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

concentration of 0.02 or higher, and the

same EBT will be used for the

confirmation test, you are not allowed to

use the EBT for a test on another

employee before completing the

confirmation test on the first employee.

(2) As a BAT who will conduct both

the screening and the confirmation test,

you are to complete the entire screening

and confirmation process on one

employee before starting the screening

process on another employee.

(3) You are not allowed to leave the

alcohol testing site while the testing

process for a given employee is in

progress, except to notify a supervisor or

contact a DER for assistance in the case

an employee or other person who

obstructs, interferes with, or

unnecessarily delays the testing process.

§ 40.225 What form is used for an alcohol

test?

(a) The DOT Alcohol Testing Form

(ATF) must be used for every DOT

alcohol test. The ATF must be a threepart carbonless manifold form. The ATF

is found in Appendix G to this part. You

may view this form on the ODAPC web

site (http://www.dot.gov/ost/dapc).

(b) As an employer in the DOT

alcohol testing program, you are not

permitted to modify or revise the ATF

except as follows:

(1) You may include other

information needed for billing purposes,

outside the boundaries of the form.

(2) You may use a ATF directly

generated by an EBT which omits the

space for affixing a separate printed

result to the ATF, provided the EBT

prints the result directly on the ATF.

(3) You may use an ATF that has the

employer’s name, address, and

telephone number preprinted. In

addition, a C/TPA’s name, address, and

telephone number may be included, to

assist with negative results.

(4) You may use an ATF in which all

pages are printed on white paper. The

white pages must have either clearly

discernible borders in the specified

color for each page or designation

statements for each copy in the

specified color.

(5) As a BAT or STT, you may add,

on the ‘‘Remarks’’ line of the ATF, the

name of the DOT agency under whose

authority the test occurred.

(6) As a BAT or STT, you may use a

ATF that has your name, address, and

telephone number preprinted, but under

no circumstances can your signature be

preprinted.

(c) As an employer, you may use an

equivalent foreign-language version of

the ATF approved by ODAPC. You may

use such a non-English language form

only in a situation where both the

employee and BAT/STT understand and

can use the form in that language.

§ 40.227 May employers use the ATF for

non-DOT tests, or non-DOT forms for DOT

tests?

(a) No, as an employer, BAT, or STT,

you are prohibited from using the ATF

for non-DOT alcohol tests. You are also

prohibited from using non-DOT forms

for DOT alcohol tests. Doing either

subjects you to enforcement action

under DOT agency regulations.

(b) If the STT or BAT, either by

mistake, or as the only means to

conduct a test under difficult

circumstances (e.g., post-accident test

with insufficient time to obtain the

ATF), uses a non-DOT form for a DOT

test, the use of a non-DOT form does

not, in and of itself, require the

employer or service agent to cancel the

test. However, in order for the test to be

considered valid, a signed statement

must be obtained from the STT or BAT

in accordance with § 40.271(b) .

§ 40.229 What devices are used to conduct

alcohol screening tests?

EBTs and ASDs on the NHTSA

conforming products lists (CPL) for

evidential and non-evidential devices

are the only devices you are allowed to

use to conduct alcohol screening tests

under this part. An ASD can be used

only for screening tests for alcohol, and

may not be used for confirmation tests.

§ 40.231 What devices are used to conduct

alcohol confirmation tests?

(a) EBTs on the NHTSA CPL for

evidential devices that meet the

requirements of paragraph (b) of this

section are the only devices you may

use to conduct alcohol confirmation

tests under this part. Note that, among

devices on the CPL for EBTs, only those

devices listed without an asterisk (*) are

authorized for use in confirmation

testing in the DOT alcohol testing

program.

(b) To conduct a confirmation test,

you must use an EBT that has the

following capabilities:

(1) Provides a printed triplicate result

(or three consecutive identical copies of

a result) of each breath test;

(2) Assigns a unique number to each

completed test, which the BAT and

employee can read before each test and

which is printed on each copy of the

result;

(3) Prints, on each copy of the result,

the manufacturer’s name for the device,

its serial number, and the time of the

test;

(4) Distinguishes alcohol from acetone

at the 0.02 alcohol concentration level;

(5) Tests an air blank; and

(6) Performs an external calibration

check.

§ 40.233 What are the requirements for

proper use and care of EBTs?

(a) As an EBT manufacturer, you must

submit, for NHTSA approval, a quality

assurance plan (QAP) for your EBT

before NHTSA places the EBT on the

CPL.

(1) Your QAP must specify the

methods used to perform external

calibration checks on the EBT, the

tolerances within which the EBT is

regarded as being in proper calibration,

and the intervals at which these checks

must be performed. In designating these

intervals, your QAP must take into

account factors like frequency of use,

environmental conditions (e.g.,

temperature, humidity, altitude) and

type of operation (e.g., stationary or

mobile).

(2) Your QAP must also specify the

inspection, maintenance, and

calibration requirements and intervals

for the EBT.

(b) As the manufacturer, you must

include, with each EBT, instructions for

its use and care consistent with the

QAP.

(c) As the user of the EBT (e.g.,

employer, service agent), you must do

the following:

(1) You must follow the

manufacturer’s instructions (see

paragraph (b) of this section), including

performance of external calibration

checks at the intervals the instructions

specify.

(2) In conducting external calibration

checks, you must use only calibration

devices appearing on NHTSA’s CPL for

‘‘Calibrating Units for Breath Alcohol

Tests.’’

(3) If an EBT fails an external check

of calibration, you must take the EBT

out of service. You may not use the EBT

again for DOT alcohol testing until it is

repaired and passes an external

calibration check.

(4) You must maintain records of the

inspection, maintenance, and

calibration of EBTs as provided in

§ 40.333(a)(2) .

(5) You must ensure that inspection,

maintenance, and calibration of the EBT

are performed by its manufacturer or a

maintenance representative certified

either by the manufacturer or by a state

health agency or other appropriate state

agency.

§ 40.235 What are the requirements for

proper use and care of ASDs?

(a) As an ASD manufacturer, you

must submit, for NHTSA approval, a

QAP for your ASD before NHTSA places

the ASD on the CPL. Your QAP must

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79557

specify the methods used for quality

control checks, temperatures at which

the ASD must be stored and used, the

shelf life of the device, and

environmental conditions (e.g.,

temperature, altitude, humidity) that

may affect the ASD’s performance.

(b) As a manufacturer, you must

include with each ASD instructions for

its use and care consistent with the

QAP. The instructions must include

directions on the proper use of the ASD,

and, where applicable the time within

which the device must be read, and the

manner in which the reading is made.

(c) As the user of the ADS (e.g.,

employer, STT), you must follow the

QAP instructions.

(d) You are not permitted to use an

ASD that does not pass the specified

quality control checks or that has passed

its expiration date.

(e) As an employer, with respect to

breath ASDs, you must also follow the

device use and care requirements of

§ 40.233 .

Subpart L—Alcohol Screening Tests

§ 40.241 What are the first steps in any

alcohol screening test?

As the BAT or STT you will take the

following steps to begin all alcohol

screening tests, regardless of the type of

testing device you are using:

(a) When a specific time for an

employee’s test has been scheduled, or

the collection site is at the employee’s

worksite, and the employee does not

appear at the collection site at the

scheduled time, contact the DER to

determine the appropriate interval

within which the DER has determined

the employee is authorized to arrive. If

the employee’s arrival is delayed

beyond that time, you must notify the

DER that the employee has not reported

for testing. In a situation where a C/TPA

has notified an owner/operator or other

individual employee to report for testing

and the employee does not appear, the

C/TPA must notify the employee that he

or she has refused to test.

(b) Ensure that, when the employee

enters the alcohol testing site, you begin

the alcohol testing process without

undue delay. For example, you must not

wait because the employee says he or

she is not ready or because an

authorized employer or employee

representative is delayed in arriving.

(1) If the employee is also going to

take a DOT drug test, you must, to the

greatest extent practicable, ensure that

the alcohol test is completed before the

urine collection process begins.

(2) If the employee needs medical

attention (e.g., an injured employee in

an emergency medical facility who is

required to have a post-accident test), do

not delay this treatment to conduct a

test.

(c) Require the employee to provide

positive identification. You must see a

photo ID issued by the employer (other

than in the case of an owner-operator or

other self-employer individual) or a

Federal, state, or local government (e.g.,

a driver’s license). You may not accept

faxes or photocopies of identification.

Positive identification by an employer

representative (not a co-worker or

another employee being tested) is also

acceptable. If the employee cannot

produce positive identification, you

must contact a DER to verify the identity

of the employee.

(d) If the employee asks, provide your

identification to the employee. Your

identification must include your name

and your employer’s name but is not

required to include your picture,

address, or telephone number.

(e) Explain the testing procedure to

the employee, including showing the

employee the instructions on the back of

the ATF.

(f) Complete Step 1 of the ATF.

(g) Direct the employee to complete

Step 2 on the ATF and sign the

certification. If the employee refuses to

sign this certification, you must

document this refusal on the ‘‘Remarks’’

line of the ATF and immediately notify

the DER. This is a refusal to test.

§ 40.243 What is the procedure for an

alcohol screening test using an EBT or nonevidential breath ASD?

As the BAT or STT, you must take the

following steps:

(a) Select, or allow the employee to

select, an individually wrapped or

sealed mouthpiece from the testing

materials.

(b) Open the individually wrapped or

sealed mouthpiece in view of the

employee and insert it into the device

in accordance with the manufacturer’s

instructions.

(c) Instruct the employee to blow

steadily and forcefully into the

mouthpiece for at least six seconds or

until the device indicates that an

adequate amount of breath has been

obtained.

(d) Show the employee the displayed

test result.

(e) If the device is one that prints the

test number, testing device name and

serial number, time, and result directly

onto the ATF, you must check to ensure

that the information has been printed

correctly onto the ATF.

(f) If the device is one that prints the

test number, testing device name and

serial number, time and result, but on a

separate printout rather than directly

onto the ATF, you must affix the

printout of the information to the

designated space on the ATF with

tamper-evident tape or use a selfadhesive label that is tamper-evident.

(g) If the device is one that does not

print the test number, testing device

name and serial number, time, and

result, or it is a device not being used

with a printer, you must record this

information in Step 3 of the ATF.

§ 40.245 What is the procedure for an

alcohol screening test using a saliva ASD?

As the STT, you must take the

following steps:

(a) Check the expiration date on the

device and show it to the employee.

You may not use the device after its

expiration date.

(b) Open an individually wrapped or

sealed package containing the device in

the presence of the employee.

(c) Offer the employee the

opportunity to use the device. If the

employee uses it, you must instruct the

employee to insert it into his or her

mouth and use it in a manner described

by the device’s manufacturer.

(d) If the employee chooses not to use

the device, or in all cases in which a

new test is necessary because the device

did not activate (see paragraph (g) of

this section), you must insert the device

into the employee’s mouth and gather

saliva in the manner described by the

device’s manufacturer. You must wear

single-use examination or similar gloves

while doing so and change them

following each test.

(e) When the device is removed from

the employee’s mouth, you must follow

the manufacturer’s instructions

regarding necessary next steps in

ensuring that the device has activated.

(f)(1) If you were unable to

successfully follow the procedures of

paragraphs (c) through (e) of this section

(e.g., the device breaks, you drop the

device on the floor), you must discard

the device and conduct a new test using

a new device.

(2) The new device you use must be

one that has been under your control or

that of the employer before the test.

(3) You must note on the ‘‘Remarks’’

line of the ATF the reason for the new

test. (Note: You may continue using the

same ATF with which you began the

test.)

(4) You must offer the employee the

choice of using the device or having you

use it unless the employee, in the

opinion of the STT or BAT, was

responsible (e.g., the employee dropped

the device) for the new test needing to

be conducted.

(5) If you are unable to successfully

follow the procedures of paragraphs (c)

79558 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

through (e) of this section on the new

test, you must end the collection and

put an explanation on the ‘‘Remarks’’

line of the ATF.

(6) You must then direct the employee

to take a new test immediately, using an

EBT for the screening test.

(g) If you are able to successfully

follow the procedures of paragraphs (c)–

(e) of this section, but the device does

not activate, you must discard the

device and conduct a new test, in the

same manner as provided in paragraph

(f) of this section. In this case, you must

place the device into the employee’s

mouth to collect saliva for the new test.

(h) You must read the result displayed

on the device no sooner than the

device’s manufacturer instructs. In all

cases the result displayed must be read

within 15 minutes of the test. You must

then show the device and its reading to

the employee and enter the result on the

ATF.

(i) You must never re-use devices,

swabs, gloves or other materials used in

saliva testing.

(j) You must note the fact that you

used a saliva ASD in Step 3 of the ATF.

§ 40.247 What procedures does the BAT or

STT follow after a screening test result?

(a) If the test result is an alcohol

concentration of less than 0.02, as the

BAT or STT, you must do the following:

(1) Sign and date Step 3 of the ATF;

and

(2) Transmit the result to the DER in

a confidential manner, as provided in

§ 40.255 .

(b) If the test result is an alcohol

concentration of 0.02 or higher, as the

BAT or STT, you must direct the

employee to take a confirmation test.

(1) If you are the BAT who will

conduct the confirmation test, you must

then conduct the test using the

procedures beginning at § 40.251 .

(2) If you are not the BAT who will

conduct the confirmation test, direct the

employee to take a confirmation test,

sign and date Step 3 of the ATF, and

give the employee Copy 2 of the ATF.

(3) If the confirmation test will be

performed at a different site from the

screening test, you must take the

following additional steps:

(i) Advise the employee not to eat,

drink, put anything (e.g., cigarette,

chewing gum) into his or her mouth, or

belch;

(ii) Tell the employee the reason for

the waiting period required by

§ 40.251(a) (i.e., to prevent an

accumulation of mouth alcohol from

leading to an artificially high reading);

(iii) Explain that following your

instructions concerning the waiting

period is to the employee’s benefit;

(iv) Explain that the confirmation test

will be conducted at the end of the

waiting period, even if the instructions

have not been followed;

(v) Note on the ‘‘Remarks’’ line of the

ATF that the waiting period instructions

were provided;

(vi) Instruct the person accompanying

the employee to carry a copy of the ATF

to the BAT who will perform the

confirmation test; and

(vii) Ensure that you or another BAT,

STT, or employer representative observe

the employee as he or she is transported

to the confirmation testing site. You

must direct the employee not to attempt

to drive a motor vehicle to the

confirmation testing site.

(c) If the screening test is invalid, you

must, as the BAT or STT, tell the

employee the test is cancelled and note

the problem on the ‘‘Remarks’’ line of

the ATF. If practicable, repeat the

testing process (see § 40. 271).

Subpart M—Alcohol Confirmation

Tests

§ 40.251 What are the first steps in an

alcohol confirmation test?

As the BAT for an alcohol

confirmation test, you must follow these

steps to begin the confirmation test

process:

(a) You must carry out a requirement

for a waiting period before the

confirmation test, by taking the

following steps:

(1) You must ensure that the waiting

period lasts at least 15 minutes, starting

with the completion of the screening

test. After the waiting period has

elapsed, you should begin the

confirmation test as soon as possible,

but not more than 30 minutes after the

completion of the screening test.

(i) If the confirmation test is taking

place at a different location from the

screening test (see § 40.247(b)(3)) the

time of transit between sites counts

toward the waiting period if the STT or

BAT who conducted the screening test

provided the waiting period

instructions.

(ii) If you cannot verify, through

review of the ATF, that waiting period

instructions were provided, then you

must carry out the waiting period

requirement.

(iii) You or another BAT or STT, or

an employer representative, must

observe the employee during the

waiting period.

(2) Concerning the waiting period,

you must tell the employee:

(i) Not to eat, drink, put anything (e.g.,

cigarette, chewing gum) into his or her

mouth, or belch;

(ii) The reason for the waiting period

(i.e., to prevent an accumulation of

mouth alcohol from leading to an

artificially high reading);

(iii) That following your instructions

concerning the waiting period is to the

employee’s benefit; and

(iv) That the confirmation test will be

conducted at the end of the waiting

period, even if the instructions have not

been followed.

(3) If you become aware that the

employee has not followed the

instructions, you must note this on the

‘‘Remarks’’ line of the ATF.

(b) If you did not conduct the

screening test for the employee, you

must require positive identification of

the employee, explain the confirmation

procedures, and use a new ATF. You

must note on the ‘‘Remarks’’ line of the

ATF that a different BAT or STT

conducted the screening test.

(c) Complete Step 1 of the ATF.

(d) Direct the employee to complete

Step 2 on the ATF and sign the

certification. If the employee refuses to

sign this certification, you must

document this refusal on the ‘‘Remarks’’

line of the ATF and immediately notify

the DER. This is a refusal to test.

(e) Even if more than 30 minutes have

passed since the screening test result

was obtained, you must begin the

confirmation test procedures in

§ 40.253, not another screening test.

(f) You must note on the ‘‘Remarks’’

line of the ATF the time that elapsed

between the two events, and if the

confirmation test could not begin within

30 minutes of the screening test, the

reason why.

(g) Beginning the confirmation test

procedures after the 30 minutes have

elapsed does not invalidate the

screening or confirmation tests, but it

may constitute a regulatory violation

subject to DOT agency sanction.

§ 40.253 What are the procedures for

conducting an alcohol confirmation test?

As the BAT conducting an alcohol

confirmation test, you must follow these

steps in order to complete the

confirmation test process:

(a) In the presence of the employee,

you must conduct an air blank on the

EBT you are using before beginning the

confirmation test and show the reading

to the employee.

(1) If the reading is 0.00, the test may

proceed. If the reading is greater than

0.00, you must conduct another air

blank.

(2) If the reading on the second air

blank is 0.00, the test may proceed. If

the reading is greater than 0.00, you

must take the EBT out of service.

(3) If you take an EBT out of service

for this reason, no one may use it for

testing until the EBT is found to be

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79559

within tolerance limits on an external

check of calibration.

(4) You must proceed with the test of

the employee using another EBT, if one

is available.

(b) You must open a new individually

wrapped or sealed mouthpiece in view

of the employee and insert it into the

device in accordance with the

manufacturer’s instructions.

(c) You must ensure that you and the

employee read the sequential test

number displayed on the EBT.

(d) You must instruct the employee to

blow steadily and forcefully into the

mouthpiece for at least six seconds or

until the device indicates that an

adequate amount of breath has been

obtained.

(e) You must show the employee the

result displayed on the EBT.

(f) You must show the employee the

result and unique test number that the

EBT prints out either directly onto the

ATF or onto a separate printout.

(g) If the EBT provides a separate

printout of the result, you must attach

the printout to the designated space on

the ATF with tamper-evident tape, or

use a self-adhesive label that is tamperevident.

§ 40.255 What happens next after the

alcohol confirmation test result?

(a) After the EBT has printed the

result of an alcohol confirmation test,

you must, as the BAT, take the

following additional steps:

(1) Sign and date Step 3 of the ATF.

(2) If the alcohol confirmation test

result is lower than 0.02, nothing further

is required of the employee. As the

BAT, you must sign and date Step 3 of

the ATF.

(3) If the alcohol confirmation test

result is 0.02 or higher, direct the

employee to sign and date Step 4 of the

ATF. If the employee does not do so,

you must note this on the ‘‘Remarks’’

line of the ATF. However, this is not

considered a refusal to test.

(4) If the test is invalid, tell the

employee the test is cancelled and note

the problem on the ‘‘Remarks’’ line of

the ATF. If practicable, conduct a retest. (see § 40.271).

(5) Immediately transmit the result

directly to the DER in a confidential

manner.

(i) You may transmit the results using

Copy 1 of the ATF, in person, by

telephone, or by electronic means. In

any case, you must immediately notify

the DER of any result of 0.02 or greater

by any means (e.g., telephone or secure

fax machine) that ensures the result is

immediately received by the DER. You

must not transmit these results through

C/TPAs or other service agents.

(ii) If you do not make the initial

transmission in writing, you must

follow up the initial transmission with

Copy 1 of the ATF.

(b) As an employer, you must take the

following steps with respect to the

receipt and storage of alcohol test result

information:

(1) If you receive any test results that

are not in writing (e.g., by telephone or

electronic means), you must establish a

mechanism to establish the identity of

the BAT sending you the results.

(2) You must store all test result

information in a way that protects

confidentiality.

Subpart N—Problems in Alcohol

Testing

§ 40.261 What is a refusal to take an

alcohol test, and what are the

consequences?

(a) As an employee, you are

considered to have refused to take an

alcohol test if you:

(1) Fail to appear for any test within

a reasonable time, as determined by the

employer, after being directed to do so

by the employer. This includes the

failure of an employee (including an

owner-operator) to appear for a test

when called by C/TPA (see

§ 40.241(b)(1));

(2) Fail to remain at the testing site

until the testing process is complete;

(3) Fail to attempt to provide a saliva

or breath specimen, as applicable, for

any test required by this part or DOT

agency regulations;

(4) Fail to provide a sufficient breath

specimen, and the physician has

determined, through a required medical

evaluation, that there was no adequate

medical explanation for the failure (see

§ 40.265(c));

(5) Fail to undergo a medical

examination or evaluation, as directed

by the employer as part of the

insufficient breath procedures outlined

at § 40.265(c);

(6) Fail to sign the certification at Step

2 of the ATF (see § 40.241(b)(7)); or

(7) Fail to cooperate with any part of

the testing process.

(b) As an employee, if you refuse to

take an alcohol test, you incur the same

consequences specified under DOT

agency regulations for a violation of

those DOT agency regulations.

(c) As a BAT or an STT, or as the

physician evaluating a ‘‘shy lung’’

situation, when an employee refuses to

test as provided in paragraph (a) of this

section, you must terminate the portion

of the testing process in which you are

involved, document the refusal on the

ATF (or in a separate document which

you cause to be attached to the form),

immediately notify the DER by any

means (e.g., telephone or secure fax

machine) that ensures the refusal

notification is immediately received.

You must make this notification directly

to the DER (not using a C/TPA as an

intermediary).

(d) As an employee, when you refuse

to take a non-DOT test or to sign a nonDOT form, you have not refused to take

a DOT test. There are no consequences

under DOT agency regulations for such

a refusal.

§ 40.263 What happens when an employee

is unable to provide a sufficient amount of

saliva for an alcohol screening test?

(a) As the STT, you must take the

following steps if an employee is unable

to provide sufficient saliva to complete

a test on a saliva screening device (e.g.,

the employee does not provide

sufficient saliva to activate the device).

(1) You must conduct a new screening

test using a new screening device.

(2) If the employee refuses to make

the attempt to complete the new test,

you must discontinue testing, note the

fact on the ‘‘Remarks’’ line of the ATF,

and immediately notify the DER. This is

a refusal to test.

(3) If the employee has not provided

a sufficient amount of saliva to complete

the new test, you must note the fact on

the ‘‘Remarks’’ line of the ATF and

immediately notify the DER.

(b) As the DER, when the STT informs

you that the employee has not provided

a sufficient amount of saliva (see

paragraph (a)(3) of this section), you

must immediately arrange to administer

an alcohol test to the employee using an

EBT or other breath testing device.

§ 40.265 What happens when an employee

is unable to provide a sufficient amount of

breath for an alcohol test?

(a) If an employee does not provide a

sufficient amount of breath to permit a

valid breath test, you must take the

steps listed in this section.

(b) As the BAT or STT, you must

instruct the employee to attempt again

to provide a sufficient amount of breath

and about the proper way to do so.

(1) If the employee refuses to make

the attempt, you must discontinue the

test, note the fact on the ‘‘Remarks’’ line

of the ATF, and immediately notify the

DER. This is a refusal to test.

(2) If the employee again attempts and

fails to provide a sufficient amount of

breath, you may provide another

opportunity to the employee to do so if

you believe that there is a strong

likelihood that it could result in

providing a sufficient amount of breath.

(3) When the employee’s attempts

under paragraph (b)(2) of this section

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have failed to produce a sufficient

amount of breath, you must note the fact

on the ‘‘Remarks’’ line of the ATF and

immediately notify the DER.

(4) If you are using an EBT that has

the capability of operating manually,

you may attempt to conduct the test in

manual mode.

(5) If you are qualified to use a saliva

ASD and you are in the screening test

stage, you may change to a saliva ASD

only to complete the screening test.

(c) As the employer, when the BAT or

STT informs you that the employee has

not provided a sufficient amount of

breath, you must direct the employee to

obtain, within five days, an evaluation

from a licensed physician who is

acceptable to you and who has expertise

in the medical issues raised by the

employee’s failure to provide a

sufficient specimen.

(1) You are required to provide the

physician who will conduct the

evaluation with the following

information and instructions:

(i) That the employee was required to

take a DOT breath alcohol test, but was

unable to provide a sufficient amount of

breath to complete the test;

(ii) The consequences of the

appropriate DOT agency regulation for

refusing to take the required alcohol

test;

(iii) That the physician must provide

you with a signed statement of his or

her conclusions; and

(iv) That the physician, in his or her

reasonable medical judgment, must base

those conclusions on one of the

following determinations:

(A) A medical condition has, or with

a high degree of probability could have,

precluded the employee from providing

a sufficient amount of breath. The

physician must not include in the

signed statement detailed information

on the employee’s medical condition. In

this case, the test is cancelled.

(B) There is not an adequate basis for

determining that a medical condition

has, or with a high degree of probability

could have, precluded the employee

from providing a sufficient amount of

breath. This constitutes a refusal to test.

(C) For purposes of paragraphs

(c)(1)(iv)(A) and (B) of this section, a

medical condition includes an

ascertainable physiological condition

(e.g., a respiratory system dysfunction)

or a medically documented pre-existing

psychological disorder, but does not

include unsupported assertions of

‘‘situational anxiety’’ or

hyperventilation.

(2) As the physician making the

evaluation, after making your

determination, you must provide a

written statement of your conclusions

and the basis for them to the DER

directly (and not through a C/TPA

acting as an itermediary). You must not

include in this statement detailed

information on the employee’s medical

condition beyond what is necessary to

explain your conclusion.

(3) Upon receipt of the report from the

examining physician, as the DER you

must immediately inform the employee

and take appropriate action based upon

your DOT agency regulations.

§ 40.267 What problems always cause an

alcohol test to be cancelled?

As an employer, a BAT, or an STT,

you must cancel an alcohol test if any

of the following problems occur. These

are ‘‘fatal flaws.’’ You must inform the

DER that the test was cancelled and

must be treated as if the test never

occurred. These problems are:

(a) In the case of a screening test

conducted on a saliva ASD:

(1) The STT reads the result either

sooner than or later than the time

allotted by the manufacturer (see

§ 40.245(h));

(2) The device does not activate (see

§ 40.245(g)); or

(3) The device is used for a test after

the expiration date printed on its

package (see § 40.245(a)).

(b) In the case of a screening or

confirmation test conducted on an EBT,

the sequential test number or alcohol

concentration displayed on the EBT is

not the same as the sequential test

number or alcohol concentration on the

printed result (see § 40.253(c), (e) and

(f)).

(c) In the case of a confirmation test:

(1) The BAT conducts the

confirmation test before the end of the

minimum 15-minute waiting period (see

§ 40.251(a)(1));

(2) The BAT does not conduct an air

blank before the confirmation test (see

§ 40.253(a));

(3) There is not a 0.00 result on the

air blank conducted before the

confirmation test (see § 40.253(a)(1) and

(2));

(4) The EBT does not print the result

(see § 40.253(f)); or

(5) The next external calibration

check of the EBT produces a result that

differs by more than the tolerance stated

in the QAP from the known value of the

test standard. In this case, every result

of 0.02 or above obtained on the EBT

since the last valid external calibration

check is cancelled (see § 40.233(a)(1)

and (d)).

§ 40.269 What problems cause an alcohol

test to be cancelled unless they are

corrected?

As a BAT or STT, or employer, you

must cancel an alcohol test if any of the

following problems occur, unless they

are corrected. These are ‘‘correctable

flaws.’’ These problems are:

(a) The BAT or STT does not sign the

ATF (see § § 40.247(a)(1) and

40.255(a)(1)).

(b) The BAT or STT fails to note on

the ‘‘Remarks’’ line of the ATF that the

employee has not signed the ATF after

the result is obtained (see

§ 40.255(a)(2)).

(c) The BAT or STT uses a non-DOT

form for the test (see § 40.225(a)).

§ 40.271 How are alcohol testing problems

corrected?

(a) As a BAT or STT, you have the

responsibility of trying to complete

successfully an alcohol test for each

employee.

(1) If, during or shortly after the

testing process, you become aware of

any event that will cause the test to be

cancelled (see § 40.267 ), you must try

to correct the problem promptly, if

practicable. You may repeat the testing

process as part of this effort.

(2) If repeating the testing process is

necessary, you must begin a new test as

soon as possible. You must use a new

ATF, a new sequential test number, and,

if needed, a new ASD and/or a new

EBT. It is permissible to use additional

technical capabilities of the EBT (e.g.,

manual operation) if you have been

trained to do so in accordance with

§ 40.213(c) .

(3) If repeating the testing process is

necessary, you are not limited in the

number of attempts to complete the test,

provided that the employee is making a

good faith effort to comply with the

testing process.

(4) If another testing device is not

available for the new test at the testing

site, you must immediately notify the

DER and advise the DER that the test

could not be completed. As the DER

who receives this information, you must

make all reasonable efforts to ensure

that the test is conducted at another

testing site as soon as possible.

(b) If, as an STT, BAT, employer or

other service agent administering the

testing process, you become aware of a

‘‘correctable flaw’’ (see § 40.269 ) that

has not already been corrected, you

must take all practicable action to

correct the problem so that the test is

not cancelled.

(1) If the problem resulted from the

omission of required information, you

must, as the person responsible for

providing that information, supply in

writing the missing information and a

signed statement that it is true and

accurate. For example, suppose you are

a BAT and you forgot to make a notation

on the ‘‘Remarks’’ line of the ATF that

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79561

the employee did not sign the

certification. You would, when the

problem is called to your attention,

supply a signed statement that the

employee failed or refused to sign the

certification after the result was

obtained, and that your signed

statement is true and accurate.

(2) If the problem is the use of a nonDOT form, you must, as the person

responsible for the use of the incorrect

form, certify in writing that the incorrect

form contains all the information

needed for a valid DOT alcohol test.

You must also provide a signed

statement that the incorrect form was

used inadvertently or as the only means

of conducting a test, in circumstances

beyond your control, and the steps you

have taken to prevent future use of nonDOT forms for DOT tests. You must

supply this information on the same

business day on which you are notified

of the problem, transmitting it by fax or

courier.

(c) If you cannot correct the problem,

you must cancel the test.

§ 40.273 What is the effect of a cancelled

alcohol test?

(a) A cancelled alcohol test is neither

positive nor negative.

(1) As an employer, you must not

attach to a cancelled test the

consequences of a test result that is 0.02

or greater (e.g., removal from a safetysensitive position).

(2) As an employer, you must not use

a cancelled test in a situation where an

employee needs a test result that is

below 0.02 (e.g., in the case of a returnto-duty or follow-up test to authorize

the employee to perform safety-sensitive

functions).

(3) As an employer, you must not

direct a recollection for an employee

because a test has been cancelled,

except in the situations cited in

paragraph (a)(2) of this section or other

provisions of this part.

(b) A cancelled test does not count

toward compliance with DOT

requirements, such as a minimum

random testing rate.

(c) When a test must be cancelled, if

you are the BAT, STT, or other person

who determines that the cancellation is

necessary, you must inform the affected

DER within 48 hours of the cancellation.

(d) A cancelled DOT test does not

provide a valid basis for an employer to

conduct a non-DOT test (i.e., a test

under company authority).

§ 40.275 What is the effect of procedural

problems that are not sufficient to cancel an

alcohol test?

(a) As an STT, BAT, employer, or a

service agent administering the testing

process, you must document any errors

in the testing process of which you

become aware, even if they are not

‘‘fatal flaws’’ or ‘‘correctable flaws’’

listed in this subpart. Decisions about

the ultimate impact of these errors will

be determined by administrative or legal

proceedings, subject to the limitation of

paragraph (b) of this section.

(b) No person concerned with the

testing process may declare a test

cancelled based on a mistake in the

process that does not have a significant

adverse effect on the right of the

employee to a fair and accurate test. For

example, it is inconsistent with this part

to cancel a test based on a minor

administrative mistake (e.g., the

omission of the employee’s middle

initial) or an error that does not affect

employee protections under this part.

Nor does the failure of an employee to

sign in Step 4 of the ATF result in the

cancellation of the test. Nor is a test to

be cancelled on the basis of a claim by

an employee that he or she was

improperly selected for testing.

(c) As an employer, these errors, even

though not sufficient to cancel an

alcohol test result, may subject you to

enforcement action under DOT agency

regulations.

§ 40.277 Are alcohol tests other than

saliva or breath permitted under these

regulations?

No, other types of alcohol tests (e,g.,

blood and urine) are not authorized for

testing done under this part. Only saliva

or breath for screening tests and breath

for confirmation tests using approved

devices are permitted.

Subpart O—Substance Abuse

Professionals and the Return-to-Duty

Process

§ 40.281 Who is qualified to act as a SAP?

To be permitted to act as a SAP in the

DOT drug testing program, you must

meet each of the requirements of this

section:

(a) Credentials. You must have one of

the following credentials:

(1) You are a licensed physician

(Doctor of Medicine or Osteopathy);

(2) You are a licensed or certified

social worker;

(3) You are a licensed or certified

psychologist;

(4) You are a licensed or certified

employee assistance professional; or

(5) You are a drug and alcohol

counselor certified by the National

Association of Alcoholism and Drug

Abuse Counselors Certification

Commission (NAADAC) or by the

International Certification Reciprocity

Consortium/Alcohol and Other Drug

Abuse (ICRC).

(b) Basic knowledge. You must be

knowledgeable in the following areas:

(1) You must be knowledgeable about

and have clinical experience in the

diagnosis and treatment of alcohol and

controlled substances-related disorders.

(2) You must be knowledgeable about

the SAP function as it relates to

employer interests in safety-sensitive

duties.

(3) You must be knowledgeable about

this part, the DOT agency regulations

applicable to the employers for whom

you evaluate employees, and the DOT

SAP Guidelines, and you keep current

on any changes to these materials. These

documents are available from ODAPC

(Department of Transportation, 400 7th

Street, SW., Room 10403, Washington

DC, 20590 (202–366–3784), or on the

ODAPC web site (http://www.dot.gov/

ost/dapc).

(c) Qualification training. You must

receive qualification training meeting

the requirements of this paragraph (c).

(1) Qualification training must

provide instruction on the following

subjects:

(i) Background, rationale, and

coverage of the Department’s drug and

alcohol testing program;

(ii) 49 CFR Part 40 and DOT agency

drug and alcohol testing rules;

(iii) Key DOT drug testing

requirements, including collections,

laboratory testing, MRO review, and

problems in drug testing;

(iv) Key DOT alcohol testing

requirements, including the testing

process, the role of BATs and STTs, and

problems in alcohol tests;

(v) SAP qualifications and

prohibitions;

(vi) The role of the SAP in the returnto-duty process, including the initial

employee evaluation, referrals for

education and/or treatment, the followup evaluation, continuing treatment

recommendations, and the follow-up

testing plan;

(vii) SAP consultation and

communication with employers, MROs,

and treatment providers;

(viii) Reporting and recordkeeping

requirements;

(ix) Issues that SAPs confront in

carrying out their duties under the

program.

(2) Following your completion of

qualification training under paragraph

(c)(1) of this section, you must

satisfactorily complete an examination

administered by a nationally-recognized

professional or training organization.

The examination must comprehensively

cover all the elements of qualification

training listed in paragraph (c)(1) of this

section.

(3) The following is the schedule for

qualification training you must meet:

79562 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

(i) If you became a SAP before August

1, 2001, you must meet the qualification

training requirement no later than

December 31, 2003.

(ii) If you become a SAP between

August 1, 2001, and December 31, 2003,

you must meet the qualification training

requirement no later than December 31,

2003.

(iii) If you become a SAP on or after

January 1, 2004, you must meet the

qualification training requirement

before you begin to perform SAP

functions.

(d) Continuing education. During each

three-year period from the date on

which you satisfactorily complete the

examination under paragraph (c)(2) of

this section, you must complete

continuing education consisting of at

least 12 professional development hours

(e.g., CEUs) relevant to performing SAP

functions.

(1) This continuing education must

include material concerning new

technologies, interpretations, recent

guidance, rule changes, and other

information about developments in SAP

practice, pertaining to the DOT program,

since the time you met the qualification

training requirements of this section.

(2) Your continuing education

activities must include documentable

assessment tools to assist you in

determining whether you have

adequately learned the material.

(e) Documentation. You must

maintain documentation showing that

you currently meet all requirements of

this section. You must provide this

documentation on request to DOT

agency representatives and to employers

and C/TPAs who are using or

contemplating using your services.

§ 40.283 How does a certification

organization obtain recognition for its

members as SAPs?

(a) If you represent a certification

organization that wants DOT to

authorize its certified drug and alcohol

counselors to be added to § 40.281(a)(5),

you may submit a written petition to

DOT requesting a review of your

petition for inclusion.

(b) You must obtain the National

Commission for Certifying Agencies

(NCCA) accreditation before DOT will

act on your petition.

(c) You must also meet the minimum

requirements of Appendix E to this part

before DOT will act on your petition.

§ 40.285 When is a SAP evaluation

required?

(a) As an employee, when you have

violated DOT drug and alcohol

regulations, you cannot again perform

any DOT safety-sensitive duties for any

employer until and unless you complete

the SAP evaluation, referral, and

education/treatment process set forth in

this subpart and in applicable DOT

agency regulations. The first step in this

process is a SAP evaluation.

(b) For purposes of this subpart, a

verified positive DOT drug test result, a

DOT alcohol test with a result

indicating an alcohol concentration of

0.04 or greater, a refusal to test

(including by adulterating or

substituting a urine specimen) or any

other violation of the prohibition on the

use of alcohol or drugs under a DOT

agency regulation constitutes a DOT

drug and alcohol regulation violation.

§ 40.287 What information is an employer

required to provide concerning SAP

services to an employee who has a DOT

drug and alcohol regulation violation?

As an employer, you must provide to

each employee (including an applicant

or new employee) who violates a DOT

drug and alcohol regulation a listing of

SAPs readily available to the employee

and acceptable to you, with names,

addresses, and telephone numbers. You

cannot charge the employee any fee for

compiling or providing this list. You

may provide this list yourself or through

a C/TPA or other service agent.

§ 40.289 Are employers required to

provide SAP and treatment services to

employees?

(a) As an employer, you are not

required to provide a SAP evaluation or

any subsequent recommended

education or treatment for an employee

who has violated a DOT drug and

alcohol regulation.

(b) However, if you offer that

employee an opportunity to return to a

DOT safety-sensitive duty following a

violation, you must, before the

employee again performs that duty,

ensure that the employee receives an

evaluation by a SAP meeting the

requirements of § 40.281 and that the

employee successfully complies with

the SAP’s evaluation recommendations.

(c) Payment for SAP evaluations and

services is left for employers and

employees to decide and may be

governed by existing management-labor

agreements and health care benefits.

§ 40.291 What is the role of the SAP in the

evaluation, referral, and treatment process

of an employee who has violated DOT

agency drug and alcohol testing

regulations?

(a) As a SAP, you are charged with:

(1) Making a face-to-face clinical

assessment and evaluation to determine

what assistance is needed by the

employee to resolve problems

associated with alcohol and/or drug use;

(2) Referring the employee to an

appropriate education and/or treatment

program;

(3) Conducting a face-to-face followup evaluation to determine if the

employee has actively participated in

the education and/or treatment program

and has demonstrated successful

compliance with the initial assessment

and evaluation recommendations;

(4) Providing the DER with a followup drug and/or alcohol testing plan for

the employee; and

(5) Providing the employee and

employer with recommendations for

continuing education and/or treatment.

(b) As a SAP, you are not an advocate

for the employer or employee. Your

function is to protect the public interest

in safety by professionally evaluating

the employee and recommending

appropriate education/treatment,

follow-up tests, and aftercare.

§ 40.293 What is the SAP’s function in

conducting the initial evaluation of an

employee?

As a SAP, for every employee who

comes to you following a DOT drug and

alcohol regulation violation, you must

accomplish the following:

(a) Provide a comprehensive face-toface assessment and clinical evaluation.

(b) Recommend a course of education

and/or treatment with which the

employee must demonstrate successful

compliance prior to returning to DOT

safety-sensitive duty.

(1) You must make such a

recommendation for every individual

who has violated a DOT drug and

alcohol regulation.

(2) You must make a recommendation

for education and/or treatment that will,

to the greatest extent possible, protect

public safety in the event that the

employee returns to the performance of

safety-sensitive functions.

(c) Appropriate education may

include, but is not limited to, self-help

groups (e.g., Alcoholics Anonymous)

and community lectures, where

attendance can be independently

verified, and bona fide drug and alcohol

education courses.

(d) Appropriate treatment may

include, but is not limited to, in-patient

hospitalization, partial in-patient

treatment, out-patient counseling

programs, and aftercare.

(e) You must provide a written report

directly to the DER highlighting your

specific recommendations for assistance

(see § 40.311(c)).

(f) For purposes of your role in the

evaluation process, you must assume

that a verified positive test result has

conclusively established that the

employee committed a DOT drug and

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79563

alcohol regulation violation. You must

not take into consideration in any way,

as a factor in determining what your

recommendation will be, any of the

following:

(1) A claim by the employee that the

test was unjustified or inaccurate;

(2) Statements by the employee that

attempt to mitigate the seriousness of a

violation of a DOT drug or alcohol

regulation (e.g., related to assertions of

use of hemp oil, ‘‘medical marijuana’’

use, ‘‘contact positives,’’ poppy seed

ingestion, job stress); or

(3) Personal opinions you may have

about the justification or rationale for

drug and alcohol testing.

(g) In the course of gathering

information for purposes of your

evaluation in the case of a drug-related

violation, you may consult with the

MRO. As the MRO, you are required to

cooperate with the SAP and provide

available information the SAP requests.

It is not necessary to obtain the consent

of the employee to provide this

information.

§ 40.295 May employees or employers

seek a second SAP evaluation if they

disagree with the first SAP’s

recommendations?

(a) As an employee with a DOT drug

and alcohol regulation violation, when

you have been evaluated by a SAP, you

must not seek a second SAP’s

evaluation in order to obtain another

recommendation.

(b) As an employer, you must not seek

a second SAP’s evaluation if the

employee has already been evaluated by

a qualified SAP. If the employee,

contrary to paragraph (a) of this section,

has obtained a second SAP evaluation,

as an employer you may not rely on it

for any purpose under this part.

§ 40.297 Does anyone have the authority

to change a SAP’s initial evaluation?

(a) Except as provided in paragraph

(b) of this section, no one (e.g., an

employer, employee, a managed-care

provider, any service agent) may change

in any way the SAP’s evaluation or

recommendations for assistance. For

example, a third party is not permitted

to make more or less stringent a SAP’s

recommendation by changing the SAP’s

evaluation or seeking another SAP’s

evaluation.

(b) The SAP who made the initial

evaluation may modify his or her initial

evaluation and recommendations based

on new or additional information (e.g.,

from an education or treatment

program).

§ 40.299 What is the SAP’s role and what

are the limits on a SAP’s discretion in

referring employees for education and

treatment?

(a) As a SAP, upon your

determination of the best

recommendation for assistance, you will

serve as a referral source to assist the

employee’s entry into a education and/

or treatment program.

(b) To prevent the appearance of a

conflict of interest, you must not refer

an employee requiring assistance to

your private practice or to a person or

organization from which you receive

payment or to a person or organization

in which you have a financial interest.

You are precluded from making referrals

to entities with which you are

financially associated.

(c) There are four exceptions to the

prohibitions contained in paragraph (b)

of this section. You may refer an

employee to any of the following

providers of assistance, regardless of

your relationship with them:

(1) A public agency (e.g., treatment

facility) operated by a state, county, or

municipality;

(2) The employer or a person or

organization under contract to the

employer to provide alcohol or drug

treatment and/or education services

(e.g., the employer’s contracted

treatment provider);

(3) The sole source of therapeutically

appropriate treatment under the

employee’s health insurance program

(e.g., the single substance abuse inpatient treatment program made

available by the employee’s insurance

coverage plan); or

(4) The sole source of therapeutically

appropriate treatment reasonably

available to the employee (e.g., the only

treatment facility or education program

reasonably located within the general

commuting area).

§ 40.301 What is the SAP’s function in the

follow-up evaluation of an employee?

(a) As a SAP, after you have

prescribed assistance under § 40.293,

you must re-evaluate the employee to

determine if the employee has

successfully carried out your education

and/or treatment recommendations.

(1) This is your way to gauge for the

employer the employee’s ability to

demonstrate successful compliance with

the education and/or treatment plan.

(2) Your evaluation may serve as one

of the reasons the employer decides to

return the employee to safety-sensitive

duty.

(b) As the SAP making the follow-up

evaluation determination, you must:

(1) Confer with or obtain appropriate

documentation from the appropriate

education and/or treatment program

professionals where the employee was

referred; and

(2) Conduct a face-to-face clinical

interview with the employee to

determine if the employee demonstrates

successful compliance with your initial

evaluation recommendations.

(c) (1) If the employee has

demonstrated successful compliance,

you must provide a written report

directly to the DER highlighting your

clinical determination that the

employee has done so with your initial

evaluation recommendation (see

§ 40.311(d)).

(2) You may determine that an

employee has successfully

demonstrated compliance even though

the employee has not yet completed the

full regimen of education and/or

treatment you recommended or needs

additional asssitance. For example, if

the employee has successfully

completed the 30-day in-patient

program you prescribed, you may make

a ‘‘successful compliance’’

determination even though you

conclude that the employee has not yet

completed the out-patient counseling

you recommended or should continue

in an aftercare program.

(d)(1) As the SAP, if you believe, as

a result of the follow-up evaluation, that

the employee has not demonstrated

successful compliance with your

recommendations, you must provide

written notice directly to the DER (see

§ 40.311(e)).

(2) As an employer who receives the

SAP’s written notice that the employee

has not successfully complied with the

SAP’s recommendations, you must not

return the employee to the performance

of safety-sensitive duties.

(3) As the SAP, you may conduct

additional follow-up evaluation(s) if the

employer determines that doing so is

consistent with the employee’s progress

as you have reported it and with the

employer’s policy and/or labormanagement agreements.

(4) As the employer, following a SAP

report that the employee has not

demonstrated successful compliance,

you may take personnel action

consistent with your policy and/or

labor-management agreements.

§ 40.303 What happens if the SAP believes

the employee needs additional treatment,

aftercare, or support group services even

after the employee returns to safetysensitive duties?

(a) As a SAP, if you believe that

ongoing services (in addition to followup tests) are needed to assist an

employee to maintain sobriety or

abstinence from drug use after the

79564 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

employee resumes the performance of

safety-sensitive duties, you must

provide recommendations for these

services in your follow-up evaluation

report (see § 40.311(d)(10)).

(b) As an employer receiving a

recommendation for these services from

a SAP, you may, as part of a return-toduty agreement with the employee,

require the employee to participate in

the recommended services. You may

monitor and document the employee’s

participation in the recommended

services. You may also make use of SAP

and employee assistance program (EAP)

services in assisting and monitoring

employees’ compliance with SAP

recommendations. Nothing in this

section permits an employer to fail to

carry out its obligations with respect to

follow-up testing (see § 40.309 ).

(c) As an employee, you are obligated

to comply with the SAP’s

recommendations for these services. If

you fail or refuse to do so, you may be

subject to disciplinary action by your

employer.

§ 40.305 How does the return-to-duty

process conclude?

(a) As the employer, if you decide that

you want to permit the employee to

return to the performance of safetysensitive functions, you must ensure

that the employee takes a return-to-duty

test. This test cannot occur until after

the SAP has determined that the

employee has successfully complied

with prescribed education and/or

treatment. The employee must have a

negative drug test result and/or an

alcohol test with an alcohol

concentration of less than 0.02 before

resuming performance of safetysensitive duties.

(b) As an employer, you must not

return an employee to safety-sensitive

duties until the employee meets the

conditions of paragraph (a) of this

section. However, you are not required

to return an employee to safety-sensitive

duties because the employee has met

these conditions. That is a personnel

decision that you have the discretion to

make, subject to collective bargaining

agreements or other legal requirements.

(c) As a SAP or MRO, you must not

make a ‘‘fitness for duty’’ determination

as part of this re-evaluation unless

required to do so under an applicable

DOT agency regulation. It is the

employer, rather than you, who must

decide whether to put the employee

back to work in a safety-sensitive

position.

§ 40.307 What is the SAP’s function in

prescribing the employee’s follow-up tests?

(a) As a SAP, for each employee who

has committed a DOT drug or alcohol

regulation violation, and who seeks to

resume the performance of safetysensitive functions, you must establish

a written follow-up testing plan. You do

not establish this plan until after you

determine that the employee has

successfully complied with your

recommendations for education and/or

treatment.

(b) You must present a copy of this

plan directly to the DER (see

§ 40.311(d)(9)).

(c) You are the sole determiner of the

number and frequency of follow-up tests

and whether these tests will be for

drugs, alcohol, or both, unless otherwise

directed by the appropriate DOT agency

regulation. For example, if the employee

had a positive drug test, but your

evaluation or the treatment program

professionals determined that the

employee had an alcohol problem as

well, you should require that the

employee have follow-up tests for both

drugs and alcohol.

(d) However, you must, at a

minimum, direct that the employee be

subject to six unannounced follow-up

tests in the first 12 months of safetysensitive duty following the employee’s

return to safety-sensitive functions.

(1) You may require a greater number

of follow-up tests during the first 12-

month period of safety-sensitive duty

(e.g., you may require one test a month

during the 12-month period; you may

require two tests per month during the

first 6-month period and one test per

month during the final 6-month period).

(2) You may also require follow-up

tests during the 48 months of safetysensitive duty following this first 12-

month period.

(3) You are not to establish the actual

dates for the follow-up tests you

prescribe. The decision on specific dates

to test is the employer’s.

(4) As the employer, you must not

impose additional testing requirements

(e.g., under company authority) on the

employee that go beyond the SAP’s

follow-up testing plan.

(e) The requirements of the SAP’s

follow-up testing plan ‘‘follow the

employee’’ to subsequent employers or

through breaks in service.

Example 1 to Paragraph (e): The employee

returns to duty with Employer A. Two

months afterward, after completing the first

two of six follow-up tests required by the

SAP’s plan, the employee quits his job with

Employer A and begins to work in a similar

position for Employer B. The employee

remains obligated to complete the four

additional tests during the next 10 months of

safety-sensitive duty, and Employer B is

responsible for ensuring that the employee

does so. Employer B learns of this obligation

through the inquiry it makes under § 40.25.

Example 2 to Paragraph (e): The employee

returns to duty with Employer A. Three

months later, after the employee completes

the first two of six follow-up tests required

by the SAP’s plan, Employer A lays the

employee off for economic or seasonal

employment reasons. Four months later,

Employer A recalls the employee. Employer

A must ensure that the employee completes

the remaining four follow-up tests during the

next nine months.

(f) As the SAP, you may modify the

determinations you have made

concerning follow-up tests. For

example, even if you recommended

follow-up testing beyond the first 12-

months, you can terminate the testing

requirement at any time after the first

year of testing. You must not, however,

modify the requirement that the

employee take at least six follow-up

tests within the first 12 months after

returning to the performance of safetysensitive functions.

§ 40.309 What are the employer’s

responsibilities with respect to the SAP’s

directions for follow-up tests?

(a) As the employer, you must carry

out the SAP’s follow-up testing

requirements. You may not allow the

employee to continue to perform safetysensitive functions unless follow-up

testing is conducted as directed by the

SAP.

(b) You should schedule follow-up

tests on dates of your own choosing, but

you must ensure that the tests are

unannounced with no discernable

pattern as to their timing, and that the

employee is given no advance notice.

(c) You cannot substitute any other

tests (e.g., those carried out under the

random testing program) conducted on

the employee for this follow-up testing

requirement.

(d) You cannot count a follow-up test

that has been cancelled as a completed

test. A cancelled follow-up test must be

recollected.

§ 40.311 What are the requirements

concerning SAP reports?

(a) As the SAP conducting the

required evaluations, you must send the

written reports required by this section

in writing directly to the DER and not

to a third party or entity for forwarding

to the DER (except as provided in

§ 40.355(e)). You may, however, forward

the document simultaneously to the

DER and to a C/TPA.

(b) As an employer, you must ensure

that you receive SAP written reports

directly from the SAP performing the

evaluation and that no third party or

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79565

entity changed the SAP’s report in any

way.

(c) The SAP’s written report,

following an initial evaluation that

determines what level of assistance is

needed to address the employee’s drug

and/or alcohol problems, must be on the

SAP’s own letterhead (and not the

letterhead of another service agent)

signed and dated by the SAP, and must

contain the following delineated items:

(1) Employee’s name and SSN;

(2) Employer’s name and address;

(3) Reason for the assessment (specific

violation of DOT regulations and

violation date);

(4) Date(s) of the assessment;

(5) SAP’s education and/or treatment

recommendation; and

(6) SAP’s telephone number.

(d) The SAP’s written report

concerning a follow-up evaluation that

determines the employee has

demonstrated successful compliance

must be on the SAP’s own letterhead

(and not the letterhead of another

service agent), signed by the SAP and

dated, and must contain the following

items:

(1) Employee’s name and SSN;

(2) Employer’s name and address;

(3) Reason for the initial assessment

(specific violation of DOT regulations

and violation date);

(4) Date(s) of the initial assessment

and synopsis of the treatment plan;

(5) Name of practice(s) or service(s)

providing the recommended education

and/or treatment;

(6) Inclusive dates of employee’s

program participation;

(7) Clinical characterization of

employee’s program participation;

(8) SAP’s clinical determination as to

whether the employee has demonstrated

successful compliance;

(9) Follow-up testing plan;

(10) Employee’s continuing care

needs with specific treatment, aftercare,

and/or support group services

recommendations; and

(11) SAP’s telephone number.

(e) The SAP’s written report

concerning a follow-up evaluation that

determines the employee has not

demonstrated successful compliance

must be on the SAP’s own letterhead

(and not the letterhead of another

service agent), signed by the SAP and

dated, and must contain the following

items:

(1) Employee’s name and SSN;

(2) Employer’s name and address;

(3) Reason for the initial assessment

(specific DOT violation and date);

(4) Date(s) of initial assessment and

synopsis of treatment plan;

(5) Name of practice(s) or service(s)

providing the recommended education

and/or treatment;

(6) Inclusive dates of employee’s

program participation;

(7) Clinical characterization of

employee’s program participation;

(8) Date(s) of the first follow-up

evaluation;

(9) Date(s) of any further follow-up

evaluation the SAP has scheduled;

(10) SAP’s clinical reasons for

determining that the employee has not

demonstrated successful compliance;

and

(11) SAP’s telephone number.

(f) As a SAP, you must also provide

these written reports directly to the

employee if the employee has no

current employer and to the gaining

DOT regulated employer in the event

the employee obtains another

transportation industry safety-sensitive

position.

(g) As a SAP, you are to maintain

copies of your reports to employers for

5 years, and your employee clinical

records in accordance with Federal,

state, and local laws regarding record

maintenance, confidentiality, and

release of information. You must make

these records available, on request, to

DOT agency representatives (e.g.,

inspectors conducting an audit or safety

investigation) and representatives of the

NTSB in an accident investigation.

(h) As an employer, you must

maintain your reports from SAPs for 5

years from the date you received them.

§ 40.313 Where is other information on

SAP functions and the return-to-duty

process found in this regulation?

You can find other information on the

role and functions of SAPs in the

following sections of this part:

§ 40.3—Definition.

§ 40.347—Service agent assistance with SAPrequired follow-up testing.

§ 40.355—Transmission of SAP reports.

§ 40.329(c)—Making SAP reports available to

employees on request.

Appendix E to Part 40—SAP Equivalency

Requirements for Certification

Organizations.

Subpart P—Confidentiality and

Release of Information

§ 40.321 What is the general confidentiality

rule for drug and alcohol test information?

Except as otherwise provided in this

subpart, as a service agent or employer

participating in the DOT drug or alcohol

testing process, you are prohibited from

releasing individual test results or

medical information about an employee

to third parties without the employee’s

specific written consent.

(a) A ‘‘third party’’ is any person or

organization to whom other subparts of

this regulation do not explicitly

authorize or require the transmission of

information in the course of the drug or

alcohol testing process.

(b) ‘‘Specific written consent’’ means

a statement signed by the employee that

he or she agrees to the release of a

particular piece of information to a

particular, explicitly identified, person

or organization at a particular time.

‘‘Blanket releases,’’ in which an

employee agrees to a release of a

category of information (e.g., all test

results) or to release information to a

category of parties (e.g., other employers

who are members of a C/TPA,

companies to which the employee may

apply for employment), are prohibited

under this part.

§ 40.323 May program participants release

drug or alcohol test information in

connection with legal proceedings?

(a) As an employer, you may release

information pertaining to an employee’s

drug or alcohol test without the

employee’s consent in certain legal

proceedings.

(1) These proceedings include a

lawsuit (e.g., a wrongful discharge

action), grievance (e.g., an arbitration

concerning disciplinary action taken by

the employer), or administrative

proceeding (e.g., an unemployment

compensation hearing) brought by, or on

behalf of, an employee and resulting

from a positive DOT drug or alcohol test

or a refusal to test (including, but not

limited to, adulterated or substituted

test results).

(2) These proceedings also include a

criminal or civil action resulting from

an employee’s performance of safetysensitive duties, in which a court of

competent jurisdiction determines that

the drug or alcohol test information

sought is relevant to the case and issues

an order directing the employer to

produce the information. For example,

in personal injury litigation following a

truck or bus collision, the court could

determine that a post-accident drug test

result of an employee is relevant to

determining whether the driver or the

driver’s employer was negligent. The

employer is authorized to respond to the

court’s order to produce the records.

(b) In such a proceeding, you may

release the information to the

decisionmaker in the proceeding (e.g.,

the court in a lawsuit). You may release

the information only with a binding

stipulation that the decisionmaker to

whom it is released will make it

available only to parties to the

proceeding.

(c) If you are a service agent, and the

employer requests its employee’s drug

or alcohol testing information from you

to use in a legal proceeding as

authorized in paragraph (a) of this

79566 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

section (e.g., the laboratory’s data

package), you must provide the

requested information to the employer.

(d) As an employer or service agent,

you must immediately notify the

employee in writing of any information

you release under this section.

§ 40.325 [Reserved]

§ 40.327 When must the MRO report

medical information gathered in the

verification process?

(a) As the MRO, you must, except as

provided in paragraph (c) of this

section, report drug test results and

medical information you learned as part

of the verification process to third

parties without the employee’s consent

if you determine, in your reasonable

medical judgment, that:

(1) The information is likely to result

in the employee being determined to be

medically unqualified under an

applicable DOT agency regulation; or

(2) The information indicates that

continued performance by the employee

of his or her safety-sensitive function is

likely to pose a significant safety risk.

(b) The third parties to whom you are

authorized to provide information by

this section include the employer, a

physician or other health care provider

responsible for determining the medical

qualifications of the employee under an

applicable DOT agency safety

regulation, a SAP evaluating the

employee as part of the return to duty

process (see § 40.293(g)), a DOT agency,

or the National Transportation Safety

Board in the course of an accident

investigation.

(c) If the law of a foreign country (e.g.,

Canada) prohibits you from providing

medical information to the employer,

you may comply with that prohibition.

§ 40.329 What information must

laboratories, MROs, and other service

agents release to employees?

(a) As an MRO or service agent you

must provide, within 10 business days

of receiving a written request from an

employee, copies of any records

pertaining to the employee’s use of

alcohol and/or drugs, including records

of the employee’s DOT-mandated drug

and/or alcohol tests. You may charge no

more than the cost of preparation and

reproduction for copies of these records.

(b) As a laboratory, you must provide,

within 10 business days of receiving a

written request from an employee, and

made through the MRO, the records

relating to the results of the employee’s

drug test (i.e., laboratory report and data

package). You may charge no more than

the cost of preparation and reproduction

for copies of these records.

(c) As a SAP, you must make available

to an employee, on request, a copy of all

SAP reports (see § 40.311).

§ 40.331 To what additional parties must

employers and service agents release

information?

As an employer or service agent you

must release information under the

following circumstances:

(a) If you receive a specific, written

consent from an employee authorizing

the release of information about that

employee’s drug or alcohol tests to an

identified person, you must provide the

information to the identified person. For

example, as an employer, when you

receive a written request from a former

employee to provide information to a

subsequent employer, you must do so.

In providing the information, you must

comply with the terms of the

employee’s consent.

(b) If you are an employer, you must,

upon request of DOT agency

representatives, provide the following:

(1) Access to your facilities used for

this part and DOT agency drug and

alcohol program functions.

(2) All written, printed, and

computer-based drug and alcohol

program records and reports (including

copies of name-specific records or

reports), files, materials, data,

documents/documentation, agreements,

contracts, policies, and statements that

are required by this part and DOT

agency regulations.

(c) If you are a service agent, you

must, upon request of DOT agency

representatives, provide the following:

(1) Access to your facilities used for

this part and DOT agency drug and

alcohol program functions.

(2) All written, printed, and

computer-based drug and alcohol

program records and reports (including

copies of name-specific records or

reports), files, materials, data,

documents/documentation, agreements,

contracts, policies, and statements that

are required by this part and DOT

agency regulations.

(d) If requested by the National

Transportation Safety Board as part of

an accident investigation, you must

provide information concerning postaccident tests administered after the

accident.

(e) If requested by a Federal, state or

local safety agency with regulatory

authority over you or the employee, you

must provide drug and alcohol test

records concerning the employee.

(f) Except as otherwise provided in

this part, as a laboratory you must not

release or provide a specimen or a part

of a specimen to a requesting party,

without first obtaining written consent

from ODAPC. If a party seeks a court

order directing you to release a

specimen or part of a specimen contrary

to any provision of this part, you must

take necessary legal steps to contest the

issuance of the order (e.g., seek to quash

a subpoena, citing the requirements of

§ 40.13 ). This part does not require you

to disobey a court order, however.

§ 40.333 What records must employers

keep?

(a) As an employer, you must keep the

following records for the following

periods of time:

(1) You must keep the following

records for five years:

(i) Records of employee alcohol test

results indicating an alcohol

concentration of 0.02 or greater;

(ii) Records of employee verified

positive drug test results;

(iii) Documentation of refusals to take

required alcohol and/or drug tests

(including substituted or adulterated

drug test results);

(iv) SAP reports; and

(v) All follow-up tests and schedules

for follow-up tests.

(2) You must keep records for three

years of information obtained from

previous employers under § 40.25

concerning drug and alcohol test results

of employees.

(3) You must keep records of the

inspection, maintenance, and

calibration of EBTs, for two years.

(4) You must keep records of negative

and cancelled drug test results and

alcohol test results with a concentration

of less than 0.02 for one year.

(b) You do not have to keep records

related to a program requirement that

does not apply to you (e.g., a maritime

employer who does not have a DOTmandated random alcohol testing

program need not maintain random

alcohol testing records).

(c) You must maintain the records in

a location with controlled access.

(d) A service agent may maintain

these records for you. However, you

must ensure that you can produce these

records at your principal place of

business in the time required by the

DOT agency. For example, as a motor

carrier, when an FMCSA inspector

requests your records, you must ensure

that you can provide them within two

working days.

Subpart Q—Roles and Responsibilities

of Service Agents

§ 40.341 Must service agents comply with

DOT drug and alcohol testing

requirements?

(a) As a service agent, the services you

provide to transportation employers

must meet the requirements of this part

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79567

and the DOT agency drug and alcohol

testing regulations.

(b) If you do not comply, DOT may

take action under the Public Interest

Exclusions procedures of this part (see

Subpart R of this part) or applicable

provisions of other DOT agency

regulations.

§ 40.343 What tasks may a service agent

perform for an employer?

As a service agent, you may perform

for employers the tasks needed to

comply with DOT agency drug and

alcohol testing regulations, subject to

the requirements and limitations of this

part.

§ 40.345 In what circumstances may a C/

TPA act as an intermediary in the

transmission of drug and alcohol testing

information to employers?

(a) As a C/TPA or other service agent,

you may act as an intermediary in the

transmission of drug and alcohol testing

information in the circumstances

specified in this section only if the

employer chooses to have you do so.

Each employer makes the decision

about whether to receive some or all of

this information from you, acting as an

intermediary, rather than directly from

the service agent who originates the

information (e.g., an MRO or BAT).

(b) The specific provisions of this part

concerning which you may act as an

intermediary are listed in Appendix F to

this part. These are the only situations

in which you may act as an

intermediary. You are prohibited from

doing so in all other situations.

(c) In every case, you must ensure

that, in transmitting information to

employers, you meet all requirements

(e.g., concerning confidentiality and

timing) that would apply if the service

agent originating the information (e.g.,

an MRO or collector) sent the

information directly to the employer.

For example, if you transmit drug

testing results from MROs to DERs, you

must transmit each drug test result to

the DER in compliance with the MRO

requirements set forth in § 40.167 .

§ 40.347 What functions may C/TPAs

perform with respect to administering

testing?

As a C/TPA, except as otherwise

specified in this part, you may perform

the following functions for employers

concerning random selection and other

selections for testing.

(a) You may operate random testing

programs for employers and may assist

(i.e., through contracting with

laboratories or collection sites,

conducting collections) employers with

other types of testing (e.g., preemployment, post-accident, reasonable

suspicion, return-to-duty, and followup).

(b) You may combine employees from

more than one employer or one

transportation industry in a random

pool if permitted by all the DOT agency

drug and alcohol testing regulations

involved.

(1) If you combine employees from

more than one transportation industry,

you must ensure that the random testing

rate is at least equal to the highest rate

required by each DOT agency.

(2) Employees not covered by DOT

agency regulations may not be part of

the same random pool with DOT

covered employees.

(c) You may assist employers in

ensuring that follow-up testing is

conducted in accordance with the plan

established by the SAP. However,

neither you nor the employer are

permitted to randomly select employees

from a ‘‘follow-up pool’’ for follow-up

testing.

§ 40.349 What records may a service agent

receive and maintain?

(a) Except where otherwise specified

in this part, as a service agent you may

receive and maintain all records

concerning DOT drug and alcohol

testing programs, including positive,

negative, and refusal to test individual

test results. You do not need the

employee’s consent to receive and

maintain these records.

(b) You may maintain all information

needed for operating a drug/alcohol

program (e.g., CCFs, ATFs, names of

employees in random pools, random

selection lists, copies of notices to

employers of selected employees) on

behalf of an employer.

(c) If a service agent originating drug

or alcohol testing information, such as

an MRO or BAT, sends the information

directly to the DER, he or she may also

provide the information simultaneously

to you, as a C/TPA or other service agent

who maintains this information for the

employer.

(d) If you are serving as an

intermediary in transmitting

information that is required to be

provided to the employer, you must

ensure that it reaches the employer in

the same time periods required

elsewhere in this part.

(e) You must ensure that you can

make available to the employer within

two days any information the employer

is asked to produce by a DOT agency

representative.

(f) On request of an employer, you

must, at any time on the request of an

employer, transfer immediately all

records pertaining to the employer and

its employees to the employer or to any

other service agent the employer

designates. You must carry out this

transfer as soon as the employer

requests it. You are not required to

obtain employee consent for this

transfer. You must not charge more than

your reasonable administrative costs for

conducting this transfer. You may not

charge a fee for the release of these

records.

(g) If you are planning to go out of

business or your organization will be

bought by or merged with another

organization, you must immediately

notify all employers and offer to transfer

all records pertaining to the employer

and its employees to the employer or to

any other service agent the employer

designates. You must carry out this

transfer as soon as the employer

requests it. You are not required to

obtain employee consent for this

transfer. You must not charge more than

your reasonable administrative costs for

conducting this transfer. You may not

charge a fee for the release of these

records.

§ 40.351 What confidentiality requirements

apply to service agents?

Except where otherwise specified in

this part, as a service agent the

following confidentiality requirements

apply to you:

(a) When you receive or maintain

confidential information about

employees (e.g., individual test results),

you must follow the same

confidentiality regulations as the

employer with respect to the use and

release of this information.

(b) You must follow all confidentiality

and records retention requirements

applicable to employers.

(c) You may not provide individual

test results or other confidential

information to another employer

without a specific, written consent from

the employee. For example, suppose

you are a C/TPA that has employers X

and Y as clients. Employee Jones works

for X, and you maintain Jones’ drug and

alcohol test for X. Jones wants to change

jobs and work for Y. You may not

inform Y of the result of a test

conducted for X without having a

specific, written consent from Jones.

Likewise, you may not provide this

information to employer Z, who is not

a C/TPA member, without this consent.

(d) You must not use blanket consent

forms authorizing the release of

employee testing information.

(e) You must establish adequate

confidentiality and security measures to

ensure that confidential employee

records are not available to

unauthorized persons. This includes

protecting the physical security of

79568 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

records, access controls, and computer

security measures to safeguard

confidential data in electronic data

bases.

§ 40.353 What principles govern the

interaction between MROs and other

service agents?

As a service agent other than an MRO

(e.g., a C/TPA), the following principles

govern your interaction with MROs:

(a) You may provide MRO services to

employers, directly or through contract,

if you meet all applicable provisions of

this part.

(b) If you employ or contract for an

MRO, the MRO must perform duties

independently and confidentially.

When you have a relationship with an

MRO, you must structure the

relationship to ensure that this

independence and confidentiality are

not compromised. Specific means

(including both physical and

operational measures, as appropriate) to

separate MRO functions and other

service agent functions are essential.

(c) Only your staff who are actually

under the day-to-day supervision and

control of an MRO with respect to MRO

functions may perform these functions.

This does not mean that those staff may

not perform other functions at other

times. However, the designation of your

staff to perform MRO functions under

MRO supervision must be limited and

not used as a subterfuge to circumvent

confidentiality and other requirements

of this part and DOT agency regulations.

You must ensure that MRO staff operate

under controls sufficient to ensure that

the independence and confidentiality of

the MRO process are not compromised.

(d) Like other MROs, an MRO you

employ or contract with must

personally conduct verification

interviews with employees and must

personally make all verification

decisions. Consequently, your staff

cannot perform these functions.

§ 40.355 What limitations apply to the

activities of service agents?

As a service agent, you are subject to

the following limitations concerning

your activities in the DOT drug and

alcohol testing program.

(a) You must not require an employee

to sign a consent, release, waiver of

liability, or indemnification agreement

with respect to any part of the drug or

alcohol testing process covered by this

part (including, but not limited to,

collections, laboratory testing, MRO,

and SAP services).

(b) You must not act as an

intermediary in the transmission of drug

test results from the laboratory to the

MRO. That is, the laboratory may not

send results to you, with you in turn

sending them to the MRO for

verification. For example, a practice in

which the laboratory transmits results to

your computer system, and you then

assign the results to a particular MRO,

is not permitted.

(c) You must not transmit drug test

results directly from the laboratory to

the employer (by electronic or other

means) or to a service agent who

forwards them to the employer. All

confirmed laboratory results must be

processed by the MRO before they are

released to any other party.

(d) You must not act as an

intermediary in the transmission of

alcohol test results of 0.02 or higher

from the STT or BAT to the DER.

(e) Except as provided in paragraph (f)

of this section, you must not act as an

intermediary in the transmission of

individual SAP reports to the actual

employer. That is, the SAP may not

send such reports to you, with you in

turn sending them to the actual

employer. However, you may maintain

individual SAP summary reports and

follow-up testing plans after they are

sent to the DER, and the SAP may

transmit such reports to you

simultaneously with sending them to

the DER.

(f) As an exception to paragraph (e) of

this section, you may act as an

intermediary in the transmission of SAP

report from the SAP to an owneroperator or other self-employed

individual.

(g) Except as provided in paragraph

(h) of this section, you must not make

decisions to test an employee based

upon reasonable suspicion, postaccident, return-to-duty, and follow-up

determination criteria. These are duties

the actual employer cannot delegate to

a C/TPA. You may, however, provide

advice and information to employers

regarding these testing issues and how

the employer should schedule required

testing.

(h) As an exception to paragraph (g)

of this section, you may make decisions

to test an employee based upon

reasonable suspicion, post-accident,

return-to-duty, and follow-up

determination criteria with respect to an

owner-operator or other self-employed

individual.

(i) Except as provided in paragraph (j)

of this section, you must not make a

determination that an employee has

refused a drug or alcohol test. This is a

non-delegable duty of the actual

employer. You may, however, provide

advice and information to employers

regarding refusal-to-test issues.

(j) As an exception to paragraph (i) of

this section, you may make a

determination that an employee has

refused a drug or alcohol test, if:

(1) You are authorized by a DOT

agency regulation to do so, you schedule

a required test for an owner-operator or

other self-employed individual, and the

individual fails to appear for the test

without a legitimate reason; or

(2) As an MRO, you determine that an

individual has refused to test on the

basis of adulteration or substitution.

(k) You must not act as a DER. For

example, while you may be responsible

for transmitting information to the

employer about test results, you must

not act on behalf of the employer in

actions to remove employees from

safety-sensitive duties.

(l) In transmitting documents to

laboratories, you must ensure that you

send to the laboratory that conducts

testing only the laboratory copy of the

CCF. You must not transmit other

copies of the CCF or any ATFs to the

laboratory.

(m) You must not impose conditions

or requirements on employers that DOT

regulations do not authorize. For

example, as a C/TPA serving employers

in the pipeline or motor carrier

industry, you must not require

employers to have provisions in their

DOT plans that RSPA or FMCSA

regulations do not require.

(n) You must not intentionally delay

the transmission of drug or alcohol

testing-related documents concerning

actions you have performed, because of

a payment dispute or other reasons.

Example 1 to Paragraph (n): A laboratory

that has tested a specimen must not delay

transmitting the documentation of the test

result to an MRO because of a billing or

payment dispute with the MRO or a C/TPA.

Example 2 to Paragraph (n): An MRO or

SAP who has interviewed an employee must

not delay sending a verified test result or

SAP report to the employer because of such

a dispute with the employer or employee.

Example 3 to Paragraph (n): A collector

who has performed a urine specimen

collection must not delay sending the drug

specimen and CCF to the laboratory because

of a payment or other dispute with the

laboratory or a C/TPA.

Example 4 to Paragraph (n): A BAT who

has conducted an alcohol test must not delay

sending test result information to an

employer or C/TPA because of a payment or

other dispute with the employer or C/TPA.

(o) While you must follow the DOT

agency regulations, the actual employer

remains accountable to DOT for

compliance, and your failure to

implement any aspect of the program as

required in this part and other

applicable DOT agency regulations

makes the employer subject to

enforcement action by the Department.

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79569

Subpart R—Public Interest Exclusions

§ 40.361 What is the purpose of a public

interest exclusion (PIE)?

(a) To protect the public interest,

including protecting transportation

employers and employees from serious

noncompliance with DOT drug and

alcohol testing rules, the Department’s

policy is to ensure that employers

conduct business only with responsible

service agents.

(b) The Department therefore uses

PIEs to exclude from participation in

DOT’s drug and alcohol testing program

any service agent who, by serious

noncompliance with this part or other

DOT agency drug and alcohol testing

regulations, has shown that it is not

currently acting in a responsible

manner.

(c) A PIE is a serious action that the

Department takes only to protect the

public interest. We intend to use PIEs

only to remedy situations of serious

noncompliance. PIEs are not used for

the purpose of punishment.

(d) Nothing in this subpart precludes

a DOT agency or the Inspector General

from taking other action authorized by

its regulations with respect to service

agents or employers that violate its

regulations.

§ 40.363 On what basis may the

Department issue a PIE?

(a) If you are a service agent, the

Department may issue a PIE concerning

you if we determine that you have failed

or refused to provide drug or alcohol

testing services consistent with the

requirements of this part or a DOT

agency drug and alcohol regulation.

(b) The Department also may issue a

PIE if you have failed to cooperate with

DOT agency representatives concerning

inspections, complaint investigations,

compliance and enforcement reviews, or

requests for documents and other

information about compliance with this

part or DOT agency drug and alcohol

regulations.

§ 40.365 What is the Department’s policy

concerning starting a PIE proceeding?

(a) It is the Department’s policy to

start a PIE proceeding only in cases of

serious, uncorrected noncompliance

with the provisions of this part,

affecting such matters as safety, the

outcomes of test results, privacy and

confidentiality, due process and fairness

for employees, the honesty and integrity

of the testing program, and cooperation

with or provision of information to DOT

agency representatives.

(b) The following are examples of the

kinds of serious noncompliance that, as

a matter of policy, the Department views

as appropriate grounds for starting a PIE

proceeding. These examples are not

intended to be an exhaustive or

exclusive list of the grounds for starting

a PIE proceeding. We intend them to

illustrate the level of seriousness that

the Department believes supports

starting a PIE proceeding. The examples

follow:

(1) For an MRO, verifying tests

positive without interviewing the

employees as required by this part or

providing MRO services without

meeting the qualifications for an MRO

required by this part;

(2) For a laboratory, refusing to

provide information to the Department,

an employer, or an employee as

required by this part; failing or refusing

to conduct a validity testing program

when required by this part; or a pattern

or practice of testing errors that result in

the cancellation of tests. (As a general

matter of policy, the Department does

not intend to initiate a PIE proceeding

concerning a laboratory with respect to

matters on which HHS initiates

certification actions under its laboratory

guidelines.);

(3) For a collector, a pattern or

practice of directly observing collections

when doing so is unauthorized, or

failing or refusing to directly observe

collections when doing so is mandatory;

(4) For collectors, BATs, or STTs, a

pattern or practice of using forms,

testing equipment, or collection kits that

do not meet the standards in this part;

(5) For a collector, BAT, or STT, a

pattern or practice of ‘‘fatal flaws’’ or

other significant uncorrected errors in

the collection process;

(6) For a laboratory, MRO or C/TPA,

failing or refusing to report tests results

as required by this part or DOT agency

regulations;

(7) For a laboratory, falsifying,

concealing, or destroying

documentation concerning any part of

the drug testing process, including, but

not limited to, documents in a

‘‘litigation package’’;

(8) For SAPs, providing SAP services

while not meeting SAP qualifications

required by this part or performing

evaluations without face-to-face

interviews;

(9) For any service agent, maintaining

a relationship with another party that

constitutes a conflict of interest under

this part (e.g., a laboratory that derives

a financial benefit from having an

employer use a specific MRO);

(10) For any service agent,

representing falsely that the service

agent or its activities is approved or

certified by the Department or a DOT

agency;

(11) For any service agent, disclosing

an employee’s test result information to

any party this part or a DOT agency

regulation does not authorize, including

by obtaining a ‘‘blanket’’ consent from

employees or by creating a data base

from which employers or others can

retrieve an employee’s DOT test results

without the specific consent of the

employee;

(12) For any service agent, interfering

or attempting to interfere with the

ability of an MRO to communicate with

the Department, or retaliating against an

MRO for communicating with the

Department;

(13) For any service agent, directing or

recommending that an employer fail or

refuse to implement any provision of

this part; or

(14) With respect to noncompliance

with a DOT agency regulation, conduct

that affects important provisions of

Department-wide concern (e.g., failure

to properly conduct the selection

process for random testing).

§ 40.367 Who initiates a PIE proceeding?

The following DOT officials may

initiate a PIE proceeding:

(a) The drug and alcohol program

manager of a DOT agency;

(b) An official of ODAPC, other than

the Director; or

(c) The designee of any of these

officials.

§ 40.369 What is the discretion of an

initiating official in starting a PIE

proceeding?

(a) Initiating officials have broad

discretion in deciding whether to start

a PIE proceeding.

(b) In exercising this discretion, the

initiating official must consider the

Department’s policy regarding the

seriousness of the service agent’s

conduct (see § 40.365) and all

information he or she has obtained to

this point concerning the facts of the

case. The initiating official may also

consider the availability of the resources

needed to pursue a PIE proceeding.

(c) A decision not to initiate a PIE

proceeding does not necessarily mean

that the Department regards a service

agent as being in compliance or that the

Department may not use other

applicable remedies in a situation of

noncompliance.

§ 40.371 On what information does an

initiating official rely in deciding whether to

start a PIE proceeding?

(a) An initiating official may rely on

credible information from any source as

the basis for starting a PIE proceeding.

(b) Before sending a correction notice

(see § 40.373), the initiating official

informally contacts the service agent to

determine if there is any information

that may affect the initiating official’s

79570 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

determination about whether it is

necessary to send a correction notice.

The initiating official may take any

information resulting from this contact

into account in determining whether to

proceed under this subpart.

§ 40.373 Before starting a PIE proceeding,

does the initiating official give the service

agent an opportunity to correct problems?

(a) If you are a service agent, the

initiating official must send you a

correction notice before starting a PIE

proceeding.

(b) The correction notice identifies the

specific areas in which you must come

into compliance in order to avoid being

subject to a PIE proceeding.

(c) If you make and document changes

needed to come into compliance in the

areas listed in the correction notice to

the satisfaction of the initiating official

within 60 days of the date you receive

the notice, the initiating official does

not start a PIE proceeding. The initiating

official may conduct appropriate fact

finding to verify that you have made

and maintained satisfactory corrections.

When he or she is satisfied that you are

in compliance, the initiating official

sends you a notice that the matter is

concluded.

§ 40.375 How does the initiating official

start a PIE proceeding?

(a) As a service agent, if your

compliance matter is not correctable

(see § 40.373(a)), or if have not resolved

compliance matters as provided in

§ 40.373(c), the initiating official starts a

PIE proceeding by sending you a notice

of proposed exclusion (NOPE). The

NOPE contains the initiating official’s

recommendations concerning the

issuance of a PIE, but it is not a decision

by the Department to issue a PIE.

(b) The NOPE includes the following

information:

(1) A statement that the initiating

official is recommending that the

Department issue a PIE concerning you;

(2) The factual basis for the initiating

official’s belief that you are not

providing drug and/or alcohol testing

services to DOT-regulated employers

consistent with the requirements of this

part or are in serious noncompliance

with a DOT agency drug and alcohol

regulation;

(3) The factual basis for the initiating

official’s belief that your noncompliance

has not been or cannot be corrected;

(4) The initiating official’s

recommendation for the scope of the

PIE;

(5) The initiating official’s

recommendation for the duration of the

PIE; and

(6) A statement that you may contest

the issuance of the proposed PIE, as

provided in § 40.379.

(c) The initiating official sends a copy

of the NOPE to the ODAPC Director at

the same time he or she sends the NOPE

to you.

§ 40.377 Who decides whether to issue a

PIE?

(a) The ODAPC Director, or his or her

designee, decides whether to issue a

PIE. If a designee is acting as the

decisionmaker, all references in this

subpart to the Director refer to the

designee.

(b) To ensure his or her impartiality,

the Director plays no role in the

initiating official’s determination about

whether to start a PIE proceeding.

(c) There is a ‘‘firewall’’ between the

initiating official and the Director. This

means that the initiating official and the

Director are prohibited from having any

discussion, contact, or exchange of

information with one another about the

matter, except for documents and

discussions that are part of the record of

the proceeding.

§ 40.379 How do you contest the issuance

of a PIE?

(a) If you receive a NOPE, you may

contest the issuance of the PIE.

(b) If you want to contest the

proposed PIE, you must provide the

Director information and argument in

opposition to the proposed PIE in

writing, in person, and/or through a

representative. To contest the proposed

PIE, you must take one or more of the

steps listed in this paragraph (b) within

30 days after you receive the NOPE.

(1) You may request that the Director

dismiss the proposed PIE without

further proceedings, on the basis that it

does not concern serious

noncompliance with this part or DOT

agency regulations, consistent with the

Department’s policy as stated in

§ 40.365.

(2) You may present written

information and arguments, consistent

with the provisions of § 40.381,

contesting the proposed PIE.

(3) You may arrange with the Director

for an informal meeting to present your

information and arguments.

(c) If you do not take any of the

actions listed in paragraph (b) of this

section within 30 days after you receive

the NOPE, the matter proceeds as an

uncontested case. In this event, the

Director makes his or her decision based

on the record provided by the initiating

official (i.e., the NOPE and any

supporting information or testimony)

and any additional information the

Director obtains.

§ 40.381 What information do you present

to contest the proposed issuance of a PIE?

(a) As a service agent who wants to

contest a proposed PIE, you must

present at least the following

information to the Director:

(1) Specific facts that contradict the

statements contained in the NOPE (see

§ 40.375(b)(2) and (3)). A general denial

is insufficient to raise a genuine dispute

over facts material to the issuance of a

PIE;

(2) Identification of any existing,

proposed or prior PIE; and

(3) Identification of your affiliates, if

any.

(b) You may provide any information

and arguments you wish concerning the

proposed issuance, scope and duration

of the PIE (see § 40.375(b)(4) and (5)).

(c) You may provide any additional

relevant information or arguments

concerning any of the issues in the

matter.

§ 40.383 What procedures apply if you

contest the issuance of a PIE?

(a) DOT conducts PIE proceedings in

a fair and informal manner. The Director

may use flexible procedures to allow

you to present matters in opposition.

The Director is not required to follow

formal rules of evidence or procedure in

creating the record of the proceeding.

(b) The Director will consider any

information or argument he or she

determines to be relevant to the decision

on the matter.

(c) You may submit any documentary

evidence you want the Director to

consider. In addition, if you have

arranged an informal meeting with the

Director, you may present witnesses and

confront any person the initiating

official presents as a witness against

you.

(d) In cases where there are material

factual issues in dispute, the Director or

his or her designee may conduct

additional fact-finding.

(e) If you have arranged a meeting

with the Director, the Director will make

a transcribed record of the meeting

available to you on your request. You

must pay the cost of transcribing and

copying the meeting record.

§ 40.385 Who bears the burden of proof in

a PIE proceeding?

(a) As the proponent of issuing a PIE,

the initiating official bears the burden of

proof.

(b) This burden is to demonstrate, by

a preponderance of the evidence, that

the service agent was in serious

noncompliance with the requirements

of this part for drug and/or alcohol

testing-related services or with the

requirements of another DOT agency

drug and alcohol testing regulation.

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79571

§ 40.387 What matters does the Director

decide concerning a proposed PIE?

(a) Following the service agent’s

response (see § 40.379(b)) or, if no

response is received, after 30 days have

passed from the date on which the

service agent received the NOPE, the

Director may take one of the following

steps:

(1) In response to a request from the

service agent (see § 40.379(b)(1)) or on

his or her own motion, the Director may

dismiss a PIE proceeding if he or she

determines that it does not concern

serious noncompliance with this part or

DOT agency regulations, consistent with

the Department’s policy as stated in

§ 40.365.

(i) If the Director dismisses a

proposed PIE under this paragraph (a),

the action is closed with respect to the

noncompliance alleged in the NOPE.

(ii) The Department may initiate a

new PIE proceeding against you on the

basis of different or subsequent conduct

that is in noncompliance with this part

or other DOT drug and alcohol testing

rules.

(2) If the Director determines that the

initiating official’s submission does not

have complete information needed for a

decision, the Director may remand the

matter to the initiating official. The

initiating official may resubmit the

matter to the Director when the needed

information is complete. If the basis for

the proposed PIE has changed, the

initiating official must send an amended

NOPE to the service agent.

(b) The Director makes determinations

concerning the following matters in any

PIE proceeding that he or she decides on

the merits:

(1) Any material facts that are in

dispute;

(2) Whether the facts support issuing

a PIE;

(3) The scope of any PIE that is

issued; and

(4) The duration of any PIE that is

issued.

§ 40.389 What factors may the Director

consider?

This section lists examples of the kind

of mitigating and aggravating factors

that the Director may consider in

determining whether to issue a PIE

concerning you, as well as the scope

and duration of a PIE. This list is not

exhaustive or exclusive. The Director

may consider other factors if

appropriate in the circumstances of a

particular case. The list of examples

follows:

(a) The actual or potential harm that

results or may result from your

noncompliance;

(b) The frequency of incidents and/or

duration of the noncompliance;

(c) Whether there is a pattern or prior

history of noncompliance;

(d) Whether the noncompliance was

pervasive within your organization,

including such factors as the following:

(1) Whether and to what extent your

organization planned, initiated, or

carried out the noncompliance;

(2) The positions held by individuals

involved in the noncompliance, and

whether your principals tolerated their

noncompliance; and

(3) Whether you had effective

standards of conduct and control

systems (both with respect to your own

organization and any contractors or

affiliates) at the time the noncompliance

occurred;

(e) Whether you have demonstrated

an appropriate compliance disposition,

including such factors as the following:

(1) Whether you have accepted

responsibility for the noncompliance

and recognize the seriousness of the

conduct that led to the cause for

issuance of the PIE;

(2) Whether you have cooperated fully

with the Department during the

investigation. The Director may

consider when the cooperation began

and whether you disclosed all pertinent

information known to you;

(3) Whether you have fully

investigated the circumstances of the

noncompliance forming the basis for the

PIE and, if so, have made the result of

the investigation available to the

Director;

(4) Whether you have taken

appropriate disciplinary action against

the individuals responsible for the

activity that constitutes the grounds for

issuance of the PIE; and

(5) Whether your organization has

taken appropriate corrective actions or

remedial measures, including

implementing actions to prevent

recurrence;

(f) With respect to noncompliance

with a DOT agency regulation, the

degree to which the noncompliance

affects matters common to the DOT drug

and alcohol testing program;

(g) Other factors appropriate to the

circumstances of the case.

§ 40.391 What is the scope of a PIE?

(a) The scope of a PIE is the

Department’s determination about the

divisions, organizational elements,

types of services, affiliates, and/or

individuals (including direct employees

of a service agent and its contractors) to

which a PIE applies.

(b) If, as a service agent, the

Department issues a PIE concerning

you, the PIE applies to all your

divisions, organizational elements, and

types of services that are involved with

or affected by the noncompliance that

forms the factual basis for issuing the

PIE.

(c) In the NOPE (see § 40.375(b)(4)),

the initiating official sets forth his or her

recommendation for the scope of the

PIE. The proposed scope of the PIE is

one of the elements of the proceeding

that the service agent may contest (see

§ 40.381(b)) and about which the

Director makes a decision (see

§ 40.387(b)(3)).

(d) In recommending and deciding the

scope of the PIE, the initiating official

and Director, respectively, must take

into account the provisions of

paragraphs (e) through (j) of this section.

(e) The pervasiveness of the

noncompliance within a service agent’s

organization (see § 40.389(d)) is an

important consideration in determining

the scope of a PIE. The appropriate

scope of a PIE grows broader as the

pervasiveness of the noncompliance

increases.

(f) The application of a PIE is not

limited to the specific location or

employer at which the conduct that

forms the factual basis for issuing the

PIE was discovered.

(g) A PIE applies to your affiliates, if

the affiliate is involved with or affected

by the conduct that forms the factual

basis for issuing the PIE.

(h) A PIE applies to individuals who

are officers, employees, directors,

shareholders, partners, or other

individuals associated with your

organization in the following

circumstances:

(1) Conduct forming any part of the

factual basis of the PIE occurred in

connection with the individual’s

performance of duties by or on behalf of

your organization; or

(2) The individual knew of, had

reason to know of, approved, or

acquiesced in such conduct. The

individual’s acceptance of benefits

derived from such conduct is evidence

of such knowledge, acquiescence, or

approval.

(i) If a contractor to your organization

is solely responsible for the conduct that

forms the factual basis for a PIE, the PIE

does not apply to the service agent itself

unless the service agent knew or should

have known about the conduct and did

not take action to correct it.

(j) PIEs do not apply to drug and

alcohol testing that DOT does not

regulate.

(k) The following examples illustrate

how the Department intends the

provisions of this section to work:

Example 1 to § 40.391. Service Agent P

provides a variety of drug testing services. P’s

SAP services are involved in a serious

violation of this Part 40. However, P’s other

79572 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

services fully comply with this part, and P’s

overall management did not plan or concur

in the noncompliance, which in fact was

contrary to P’s articulated standards. Because

the noncompliance was isolated in one area

of the organization’s activities, and did not

pervade the entire organization, the scope of

the PIE could be limited to SAP services.

Example 2 to § 40.391. Service Agent Q

provides a similar variety of services. The

conduct forming the factual basis for a PIE

concerns collections for a transit authority.

As in Example 1, the noncompliance is not

pervasive throughout Q’s organization. The

PIE would apply to collections at all

locations served by Q, not just the particular

transit authority or not just in the state in

which the transit authority is located.

Example 3 to § 40.391. Service Agent R

provides a similar array of services. One or

more of the following problems exists: R’s

activities in several areas—collections,

MROs, SAPs, protecting the confidentiality of

information—are involved in serious

noncompliance; DOT determines that R’s

management knew or should have known

about serious noncompliance in one or more

areas, but management did not take timely

corrective action; or, in response to an

inquiry from DOT personnel, R’s

management refuses to provide information

about its operations. In each of these three

cases, the scope of the PIE would include all

aspects of R’s services.

Example 4 to § 40.391. Service Agent W

provides only one kind of service (e.g.,

laboratory or MRO services). The Department

issues a PIE concerning these services.

Because W only provides this one kind of

service, the PIE necessarily applies to all its

operations.

Example 5 to § 40.391. Service Agent X, by

exercising reasonably prudent oversight of its

collection contractor, should have known

that the contractor was making numerous

‘‘fatal flaws’’ in tests. Alternatively, X

received a correction notice pointing out

these problems in its contractor’s collections.

In neither case did X take action to correct

the problem. X, as well as the contractor,

would be subject to a PIE with respect to

collections.

Example 6 to § 40.391. Service Agent Y

could not reasonably have known that one of

its MROs was regularly failing to interview

employees before verifying tests positive.

When it received a correction notice, Y

immediately dismissed the erring MRO. In

this case, the MRO would be subject to a PIE

but Y would not.

Example 7 to § 40.391. The Department

issues a PIE with respect to Service Agent Z.

Z provides services for DOT-regulated

transportation employers, a Federal agency

under the HHS-regulated Federal employee

testing program, and various private

businesses and public agencies that DOT

does not regulate. The PIE applies only to the

DOT-regulated transportation employers with

respect to their DOT-mandated testing, not to

the Federal agency or the other public

agencies and private businesses. The PIE

does not prevent the non-DOT regulated

entities from continuing to use Z’s services.

§ 40.393 How long does a PIE stay in

effect?

(a) In the NOPE (see § 40.375(b)(5)),

the initiating official proposes the

duration of the PIE. The duration of the

PIE is one of the elements of the

proceeding that the service agent may

contest (see § 40.381(b)) and about

which the Director makes a decision

(see § 40.387(b)(4)).

(b) In deciding upon the duration of

the PIE, the Director considers the

seriousness of the conduct on which the

PIE is based and the continued need to

protect employers and employees from

the service agent’s noncompliance. The

Director considers factors such as those

listed in § 40.389 in making this

decision.

(c) The duration of a PIE will be

between one and five years, unless the

Director reduces its duration under

§ 40.407.

§ 40.395 Can you settle a PIE proceeding?

At any time before the Director’s

decision, you and the initiating official

can, with the Director’s concurrence,

settle a PIE proceeding.

§ 40.397 When does the Director make a

PIE decision?

The Director makes his or her

decision within 60 days of the date

when the record of a PIE proceeding is

complete (including any meeting with

the Director and any additional factfinding that is necessary). The Director

may extend this period for good cause

for additional periods of up to 30 days.

§ 40.399 How does the Department notify

service agents of its decision?

If you are a service agent involved in

a PIE proceeding, the Director provides

you written notice as soon as he or she

makes a PIE decision. The notice

includes the following elements:

(a) If the decision is not to issue a PIE,

a statement of the reasons for the

decision, including findings of fact with

respect to any material factual issues

that were in dispute.

(b) If the decision is to issue a PIE—

(1) A reference to the NOPE;

(2) A statement of the reasons for the

decision, including findings of fact with

respect to any material factual issues

that were in dispute;

(3) A statement of the scope of the

PIE; and

(4) A statement of the duration of the

PIE.

§ 40.401 How does the Department notify

employers and the public about a PIE?

(a) The Department maintains a

document called the ‘‘List of Excluded

Drug and Alcohol Service Agents.’’ This

document may be found on the

Department’s web site (http://

www.dot.gov/ost/dapc). You may also

request a copy of the document from

ODAPC.

(b) When the Director issues a PIE, he

or she adds to the List the name and

address of the service agent, and any

other persons or organizations, to whom

the PIE applies and information about

the scope and duration of the PIE.

(c) When a service agent ceases to be

subject to a PIE, the Director removes

this information from the List.

(d) The Department also publishes a

Federal Register notice to inform the

public on any occasion on which a

service agent is added to or taken off the

List.

§ 40.403 Must a service agent notify its

clients when the Department issues a PIE?

(a) As a service agent, if the

Department issues a PIE concerning

you, you must notify each of your DOTregulated employer clients, in writing,

about the issuance, scope, duration, and

effect of the PIE. You may meet this

requirement by sending a copy of the

Director’s PIE decision or by a separate

notice. You must send this notice to

each client within three working days of

receiving from the Department the

notice provided for in § 40.399(b).

(b) As part of the notice you send

under paragraph (a) of this section, you

must offer to transfer immediately all

records pertaining to the employer and

its employees to the employer or to any

other service agent the employer

designates. You must carry out this

transfer as soon as the employer

requests it.

§ 40.405 May the Federal courts review PIE

decisions?

The Director’s decision is a final

administrative action of the Department.

Like all final administrative actions of

Federal agencies, the Director’s decision

is subject to judicial review under the

Administrative Procedure Act (5 U.S.C.

551 et. seq).

§ 40.407 May a service agent ask to have

a PIE reduced or terminated?

(a) Yes, as a service agent concerning

whom the Department has issued a PIE,

you may request that the Director

terminate a PIE or reduce its duration

and/or scope. This process is limited to

the issues of duration and scope. It is

not an appeal or reconsideration of the

decision to issue the PIE.

(b) Your request must be in writing

and supported with documentation.

(c) You must wait at least nine

months from the date on which the

Director issued the PIE to make this

request.

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79573

(d) The initiating official who was the

proponent of the PIE may provide

information and arguments concerning

your request to the Director.

(e) If the Director verifies that the

sources of your noncompliance have

been eliminated and that all drug or

alcohol testing-related services you

would provide to DOT-regulated

employers will be consistent with the

requirements of this part, the Director

may issue a notice terminating or

reducing the PIE.

§ 40.409 What does the issuance of a PIE

mean to transportation employers?

(a) As an employer, you are deemed

to have notice of the issuance of a PIE

when it appears on the List mentioned

in § 40.401(a) or the notice of the PIE

appears in the Federal Register as

provided in § 40.401(d). You should

check this List to ensure that any service

agents you are using or planning to use

are not subject to a PIE.

(b) As an employer who is using a

service agent concerning whom a PIE is

issued, you must stop using the services

of the service agent no later than 90

days after the Department has published

the decision in the Federal Register or

posted it on its web site. You may apply

to the ODAPC Director for an extension

of 30 days if you demonstrate that you

cannot find a substitute service agent

within 90 days.

(c) Except during the period provided

in paragraph (b) of this section, you

must not, as an employer, use the

services of a service agent that are

covered by a PIE that the Director has

issued under this subpart. If you do so,

you are in violation of the Department’s

regulations and subject to applicable

DOT agency sanctions (e.g., civil

penalties, withholding of Federal

financial assistance).

(d) You also must not obtain drug or

alcohol testing services through a

contractor or affiliate of the service

agent to whom the PIE applies.

Example to Paragraph (d): Service Agent R

was subject to a PIE with respect to SAP

services. As an employer, not only must you

not use R’s own SAP services, but you also

must not use SAP services you arrange

through R, such as services provided by a

subcontractor or affiliate of R or a person or

organization that receives financial gain from

its relationship with R.

(e) This section’s prohibition on using

the services of a service agent

concerning which the Director has

issued a PIE applies to employers in all

industries subject to DOT drug and

alcohol testing regulations.

Example to Paragraph (e): The initiating

official for a PIE was the FAA drug and

alcohol program manager, and the conduct

forming the basis of the PIE pertained to the

aviation industry. As a motor carrier, transit

authority, pipeline, railroad, or maritime

employer, you are also prohibited from using

the services of the service agent involved in

connection with the DOT drug and alcohol

testing program.

(f) The issuance of a PIE does not

result in the cancellation of drug or

alcohol tests conducted using the

service agent involved before the

issuance of the Director’s decision or up

to 90 days following its publication in

the Federal Register or posting on the

Department’s web site, unless otherwise

specified in the Director’s PIE decision

or the Director grants an extension as

provided in paragraph (b) of this

section.

Example to Paragraph (f): The Department

issues a PIE concerning Service Agent N on

September 1. All tests conducted using N’s

services before September 1, and through

November 30, are valid for all purposes

under DOT drug and alcohol testing

regulations, assuming they meet all other

regulatory requirements.

§ 40.411 What is the role of the DOT

Inspector General’s office?

(a) Any person may bring concerns

about waste, fraud, or abuse on the part

of a service agent to the attention of the

DOT Office of Inspector General.

(b) In appropriate cases, the Office of

Inspector General may pursue criminal

or civil remedies against a service agent.

(c) The Office of Inspector General

may provide factual information to

other DOT officials for use in a PIE

proceeding.

§ 40.413 How are notices sent to service

agents?

(a) If you are a service agent, DOT

sends notices to you, including

correction notices, notices of proposed

exclusion, decision notices, and other

notices, in any of the ways mentioned

in paragraph (b) or (c) of this section.

(b) DOT may send a notice to you,

your identified counsel, your agent for

service of process, or any of your

partners, officers, directors, owners, or

joint venturers to the last known street

address, fax number, or e-mail address.

DOT deems the notice to have been

received by you if sent to any of these

persons.

(c) DOT considers notices to be

received by you—

(1) When delivered, if DOT mails the

notice to the last known street address,

or five days after we send it if the letter

is undeliverable;

(2) When sent, if DOT sends the

notice by fax or five days after we send

it if the fax is undeliverable; or

(3) When delivered, if DOT sends the

notice by e-mail or five days after DOT

sends it if the e-mail is undeliverable.

Appendix A to Part 40—DOT Standards

for Urine Collection Kits

The Collection Kit Contents

1. Collection Container

a. Single-use container, made of plastic,

large enough to easily catch and hold at least

55 mL of urine voided from the body.

b. Must have graduated volume markings

clearly noting levels of 45 mL and above.

c. Must have a temperature strip providing

graduated temperature readings 32–38 °C/90–

100 °F, that is affixed or can be affixed at a

proper level on the outside of the collection

container. Other methodologies (e.g.,

temperature device built into the wall of the

container) are acceptable provided the

temperature measurement is accurate and

such that there is no potential for

contamination of the specimen.

d. Must be individually wrapped in a

sealed plastic bag or shrink wrapping; or

must have a peelable, sealed lid or other

easily visible tamper-evident system.

e. May be made available separately at

collection sites to address shy bladder

situations when several voids may be

required to complete the testing process.

2. Plastic Specimen Bottles

a. Each bottle must be large enough to hold

at least 35 mL; or alternatively, they may be

two distinct sizes of specimen bottles

provided that the bottle designed to hold the

primary specimen holds at least 35 mL of

urine and the bottle designed to hold the

split specimen holds at least 20 mL.

b. Must have screw-on or snap-on caps that

prevent seepage of the urine from the bottles

during shipment.

c. Must have markings clearly indicating

the appropriate levels (30 mL for the primary

specimen and 15 mL for the split) of urine

that must be poured into the bottles.

d. Must be designed so that the required

tamper-evident bottle seals made available on

the CCF fit with no damage to the seal when

the employee initials it nor with the chance

that the seal overlap would conceal printed

information.

e. Must be wrapped (with caps) together in

a sealed plastic bag or shrink wrapping

separate from the collection container; or

must be wrapped (with cap) individually in

sealed plastic bags or shrink wrapping; or

must have peelable, sealed lid or other easily

visible tamper-evident system.

f. Plastic material must be leach resistant.

3. Leak-Resistant Plastic Bag

a. Must have two sealable compartments or

pouches which are leak-resistant; one large

enough to hold two specimen bottles and the

other large enough to hold the CCF

paperwork.

b. The sealing methodology must be such

that once the compartments are sealed, any

tampering or attempts to open either

compartment will be evident.

4. Absorbent material

Each kit must contain enough absorbent

material to absorb the entire contents of both

specimen bottles. Absorbent material must be

designed to fit inside the leak-resistant

79574 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

plastic bag pouch into which the specimen

bottles are placed.

5. Shipping Container

a. Must be designed to adequately protect

the specimen bottles from shipment damage

in the transport of specimens from the

collection site to the laboratory (e.g., standard

courier box, small cardboard box, plastic

container).

b. May be made available separately at

collection sites rather than being part of an

actual kit sent to collection sites.

c. A shipping container is not necessary if

a laboratory courier hand-delivers the

specimen bottles in the plastic leak-proof

bags from the collection site to the laboratory.

Appendix B to Part 40—DOT Drug

Testing Semi-Annual Laboratory

Report

The following items are required on each

report:

Reporting Period: (inclusive dates)

Laboratory Identification: (name and address)

Employer Identification: (name; may include

billing code or ID code)

C/C/TPA Identification: (where applicable;

name and address)

1. Number of specimen results reported:

(total number)

By test type:

(a) Pre-employment testing: (number)

(b) Post-accident testing: (number)

(c) Random testing: (number)

(d) Reasonable suspicion/cause testing:

(number)

(e) Return-to-duty testing: (number)

(f) Follow-up testing: (number)

(g) Type not noted on CCF: (number)

2. Number of specimens reported as

(a) Negative: (total number)

(b) Negative-dilute: (number)

3. Number of specimens reported as Rejected

for Testing: (total number)

By reason:

(a) Fatal flaw: (number)

(b) Uncorrected flaw: (number)

4. Number of specimens reported as Positive:

(total number)

By drug:

(a) Marijuana Metabolite: (number)

(b) Cocaine Metabolite: (number)

(c) Opiates:

(1) Codeine: (number)

(2) Morphine: (number)

(3) 6–AM: (number)

(d) Phencyclidine: (number)

(e) Amphetamines: (number)

(1) Amphetamine: (number)

(2) Methamphetamine: (number):

5. Adulterated: (number)

6. Substituted: (number)

7. Invalid results: (number)

Appendix C to Part 40—[Reserved]

Appendix D to Part 40—Report Format: Split

Specimen Failure to Reconfirm

Fax or mail to: Department of

Transportation, Office of Drug and Alcohol

Policy and Compliance, 400 7th Street, SW.,

Room 10403, Washington, DC 20590 (fax)

202–366–3897.

1. MRO name, address, phone number, and

fax number.

2. Collection site name, address, and phone

number.

3. Date of collection.

4. Specimen I.D. number.

5. Laboratory accession number.

6. Primary specimen laboratory name,

address, and phone number.

7. Date result reported or certified by

primary laboratory.

8. Split specimen laboratory name,

address, and phone number.

9. Date split specimen result reported or

certified by split specimen laboratory.

10. Primary specimen results (e.g., name of

drug, adulterant) in the primary specimen.

11. Reason for split specimen failure-toreconfirm result (e.g., drug or adulterant not

present, specimen invalid, split not collected,

insufficient volume).

12. Actions taken by the MRO (e.g.,

notified employer of failure to reconfirm and

requirement for recollection).

13. Additional information explaining the

reason for cancellation.

14. Name of individual submitting the

report (if not the MRO).

Appendix E to Part 40—SAP

Equivalency Requirements for

Certification Organizations

1. Experience: Minimum requirements are

for three years of full-time supervised

experience or 6,000 hours of supervised

experience as an alcoholism and/or drug

abuse counselor. The supervision must be

provided by a licensed or certified

practitioner. Supervised experience is

important if the individual is to be

considered a professional in the field of

alcohol and drug abuse evaluation and

counseling.

2. Education: There exists a requirement of

270 contact hours of education and training

in alcoholism and/or drug abuse or related

training. These hours can take the form of

formal education, in-service training, and

professional development courses. Part of

any professional counselor’s development is

participation in formal and non-formal

education opportunities within the field.

3. Continuing Education: The certified

counselor must receive at least 40–60 hours

of continuing education units (CEU) during

each two year period. These CEUs are

important to the counselor’s keeping abreast

of changes and improvements in the field.

4. Testing: A passing score on a national

test is a requirement. The test must

accurately measure the application of the

knowledge, skills, and abilities possessed by

the counselor. The test establishes a national

standard that must be met to practice.

5. Testing Validity: The certification

examination must be reviewed by an

independent authority for validity

(examination reliability and relationship to

the knowledge, skills, and abilities required

by the counseling field). The reliability of the

exam is paramount if counselor attributes are

to be accurately measured. The examination

passing score point must be placed at an

appropriate minimal level score as gauged by

statistically reliable methodology.

6. Measurable Knowledge Base: The

certification process must be based upon

measurable knowledge possessed by the

applicant and verified through collateral data

and testing. That level of knowledge must be

of sufficient quantity to ensure a high quality

of SAP evaluation and referral services.

7. Measurable Skills Base: The certification

process must be based upon measurable

skills possessed by the applicant and verified

through collateral data and testing. That level

of skills must be of sufficient quality to

ensure a high quality of SAP evaluation and

referral services.

8. Quality Assurance Plan: The

certification agency must ensure that a means

exists to determine that applicant records are

verified as being true by the certification

staff. This is an important check to ensure

that true information is being accepted by the

certifying agency.

9. Code of Ethics: Certified counselors

must pledge to adhere to an ethical standard

for practice. It must be understood that code

violations could result in de-certification.

These standards are vital in maintaining the

integrity of practitioners. High ethical

standards are required to ensure quality of

client care and confidentiality of client

information as well as to guard against

inappropriate referral practices.

10. Re-certification Program: Certification

is not just a one-time event. It is a continuing

privilege with continuing requirements.

Among these are continuing education,

continuing state certification, and

concomitant adherence to the code of ethics.

Re-certification serves as a protector of client

interests by removing poor performers from

the certified practice.

11. Fifty State Coverage: Certification must

be available to qualified counselors in all 50

states and, therefore, the test must be

available to qualified applicants in all 50

states. Because many companies are multistate operators, consistency in SAP

evaluation quality and opportunities is

paramount. The test need not be given in all

50 states but should be accessible to

candidates from all states.

12. National Commission for Certifying

Agencies (NCCA) Accreditation: Having

NCCA accreditation is a means of

demonstrating to the Department of

Transportation that your certification has

been reviewed by a panel of impartial experts

that have determined that your

examination(s) has met stringent and

appropriate testing standards.

Appendix F to Part 40—Drug and

Alcohol Testing Information that C/

TPAs May Transmit to Employers

1. If you are a C/TPA, you may, acting as

an intermediary, transmit the information in

the following sections of this part to the DER

for an employer, if the employer chooses to

have you do so. These are the only items that

you are permitted to transmit to the employer

as an intermediary. The use of C/TPA

intermediaries is prohibited in all other

cases, such as transmission of laboratory drug

test results to MROs, the transmission of

medical information from MROs to

employers, the transmission of SAP reports

to employers, the transmission of positive

alcohol test results, and the transmission of

medical information from MROs to

employers.

2. In every case, you must ensure that, in

transmitting the information, you meet all

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79575

requirements (e.g., concerning confidentiality

and timing) that would apply if the party

originating the information (e.g., an MRO or

collector) sent the information directly to the

employer. For example, if you transmit

MROs’ drug testing results to DERs, you must

transmit each drug test result to the DER in

compliance with the requirements for MROs

set forth in § 40.167.

Drug Testing Information

§ 40.25: Previous two years’ test results

§ 40.35: Notice to collectors of contact

information for DER

§ 40.61(a): Notification to DER that an

employee is a ‘‘no show’’ for a drug test

§ 40.63(e): Notification to DER of a collection

under direct observation

§ 40.65(b)(6) and (7) and (c)(2) and (3):

Notification to DER of a refusal to

provide a specimen or an insufficient

specimen

§ 40.73(a)(9): Transmission of CCF copies to

DER (However, MRO copy of CCF must

be sent by collector directly to the MRO,

not through the C/TPA.)

§ 40.111(a): Transmission of laboratory

statistical report to employer

§ 40.129 (d): Report of test results to DER

§ 40.129(f)(1): Report to DER of confirmed

positive test in stand-down situation

§ 40.149(b): Report to DER of changed test

result

§ 40.155(a): Report to DER of dilute specimen

§§ 40.159(a)(4)(ii); 40.161(b): Reports to DER

that test is cancelled

§ 40.167(b) and (c): Reports of test results to

DER

§ 40.187(a), (b)(1), (c)(1), (d)(1) and (2):

Reports to DER concerning the

reconfirmation of tests

§ 40.191(d): Notice to DER concerning

refusals to test

§ 40.193(b)(3): Notification to DER of refusal

in shy bladder situation

§ 40.193(b)(4): Notification to DER of

insufficient specimen

§ 40.193(b)(5): Transmission of CCF copies to

DER (not to MRO)

§ 40.199: Report to DER of cancelled test and

direction to DER for additional collection

§ 40.201: Report to DER of cancelled test

Alcohol Testing Information

§ 40.215: Notice to BATs and STTs of contact

information for DER

§ 40.241(b)(1): Notification to DER that an

employee is a ‘‘no show’’ for an alcohol

test

§ 40.247(a)(2): Transmission of alcohol

screening test results only when the test

result is less than 0.02

§ 40.255(a)(4): Transmission of alcohol

confirmation test results only when the

test result is less than 0.02

§ 40.263(a)(3) and 263(b)(3): Notification of

insufficient saliva and failure to provide

sufficient amount of breath

Appendix G to Part 40—Alcohol

Testing Form

The following form is the alcohol testing

form required for use in the DOT alcohol

testing program beginning August 1, 2001.

Use of the form is authorized beginning

January 18, 2001.

BILLING CODE 4910–62–P

79576 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79577

79578 Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations

Federal Register / Vol. 65, No. 244 / Tuesday, December 19, 2000 / Rules and Regulations 79579

[FR Doc. 00–31251 Filed 12–14–00; 2:49 pm]

BILLING CODE 4910–62–C