[Federal Register Volume 66, Number 154 (Thursday, August 9, 2001)]
[Rules and Regulations]
[Pages 41944-41955]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-19232]



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Part II





Department of Transportation





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Office of the Secretary



49 CFR Part 40



Federal Aviation Administration

14 CFR Part 121



Coast Guard

46 CFR Parts 4, 5, and 16



Research and Special Programs Administration

49 CFR Part 199



Federal Railroad Administration

49 CFR Part 219



Federal Motor Carrier Safety Administration

49 CFR Part 382



Federal Transit Administration

49 CFR Parts 653, 654, and 655



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Procedures for Transportation Workplace Drug and Alcohol Testing 
Programs; Antidrug and Alcohol Misuse Prevention Programs for Personnel 
Engaged in Specified Aviation Activities; Final Rules

  Federal Register / Vol. 66, No. 154 / Thursday, August 9, 2001 / 
Rules and Regulations  

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

49 CFR Part 40

[Docket OST-99-6578]
RIN 2105-AD02


Procedures for Transportation Workplace Drug and Alcohol Testing 
Programs; Technical Amendments

AGENCY: Office of the Secretary, DOT.

ACTION: Final rule.

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SUMMARY: The Department of Transportation is making a series of 
technical amendments to its drug and alcohol testing procedural rule, 
which goes into effect August 1, 2001. The purpose of these technical 
amendments is to clarify certain provisions of the rule and address 
omissions or problems which have been called to our attention since the 
publication of the final rule in December 2000.

DATES: This rule 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 [email protected] (e-mail); or Kenneth Edgell, Acting 
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 [email protected] (e-mail).

SUPPLEMENTARY INFORMATION: The Department of Transportation published 
revised procedures for its drug and alcohol testing program (49 CFR 
Part 40) on December 19, 2000 (65 FR 79462). This revised rule goes 
into effect, in its entirety, on August 1, 2001, replacing the previous 
version of Part 40. The new Part 40 is a comprehensive revision of the 
Department's testing procedures, making numerous and detailed 
substantive and organizational changes in the regulation. Not 
surprisingly for a document of this magnitude, we have noticed--and 
interested persons have called to our attention--instances in which the 
text of various sections of the regulation should be clarified or 
errors, omissions, or problems should be corrected.
    This technical amendments document is intended to make these 
clarifications and corrections. The technical amendments were prepared 
with the intention of going into effect on August 1, 2001, so that 
users of the regulation will have the opportunity to use the amended 
version of the regulation without any delay. In the event that 
publication of the rule does not occur until after August 1, we request 
that interested parties be guided by the amended provisions of the 
rule, which we will have posted on our docket and web site by that 
date. In particular, we emphasize the Department's intention that 
validity testing remain voluntary at this time. Because we realize that 
regulated parties will have had little time to incorporate these 
technical amendments, the Department, in its implementation and 
enforcement work, will provide a reasonable time to permit parties to 
make necessary changes in their procedures to comply with these 
amendments.

Section 40.3  Definitions

    The Department is adding a new definition of ``invalid drug test.'' 
This term is used in the new Federal Custody and Control Form (CCF) 
that becomes mandatory on August 1, but was not previously defined in 
Part 40. This definition is also expected to be included in the 
forthcoming Department of Health and Human Services (HHS) proposed 
amendments to their Mandatory Guidelines for drug testing.
    In the definition of ``designated employer representative (DER),'' 
we are making a clarification by explicitly adding the function of 
``causing employees to be removed from these [i.e., safety-sensitive] 
functions.'' This addition is to cover the situation where the DER does 
not personally and directly remove the individual from safety-sensitive 
functions, but, for example, calls the individual's supervisor, who 
effects the actual removal.

Section 40.27  May an Employer Require an Employee To Sign a Consent or 
Release in Connection With the DOT Drug and Alcohol Testing Program?

    Part 40 states that service agents cannot require an employee to 
sign a consent, release, waiver of liability, or indemnification 
agreement with respect to any part of the DOT drug or alcohol testing 
process. We inadvertently omitted language applying this same 
prohibition to employers. Lately, we have become aware that some 
employers and others are forcing employees to sign such documents. We 
want to clarify that no one can do so either on their own or a service 
agent's behalf. This new section and a parallel change in Sec. 40.355 
provide this clarification.

Section 40.33  What Training Requirements Must a Collector Meet?

    In new Sec. 40.208, the Department is changing the procedure for 
handling a situation in which a collector fails to record the specimen 
temperature. Since this mistake is no longer one that will require 
cancellation of a test, error correction training will not apply in 
that case. The purpose of the amendment to Sec. 40.33(c)(2) is to 
clarify that we intend all monitors (i.e., persons who make sure that 
collector trainees successfully complete the mock collections required 
by the rule) to have successfully completed qualification training for 
collectors, even if they have had a year's training experience or a 
train the trainer course.

Section 40.45  What Form Is Used To Document a DOT Urine Collection?

    The Department has become aware that employers and collection 
sites, in some cases, are having a very difficult time obtaining copies 
of the new CCF that becomes mandatory on August 1, 2001. There may be 
some confusion among laboratories and other parties concerning whether 
DOT and HHS really mean that all Federal collections beginning August 1 
must be conducted on the new form. The Department has added a paragraph 
to this section to emphasize that use of the new form is mandatory and 
that participants must stop using the old form.
    This new paragraph provides that participants must not use a non-
Federal form or an expired Federal form (like the old CCF) to conduct a 
DOT urine collection. Laboratories, C/TPAs and other parties that 
distribute CCFs to employers, collection sites, or other customers must 
not send any more copies of the old CCF to these participants. Parties 
who distribute forms must also affirmatively notify other participants 
that they must not use the expired Federal form.
    The Department is also making changes to Secs. 40.83, 40.203, and 
40.205 concerning the requirement to use the new CCF and corrective 
action that must be taken if the old CCF is used.
    In addition, we are aware that some employers may wish to use C/
TPAs to receive and maintain CCFs that come directly from the 
collection site. When this is the case--and we emphasize that this is 
the employer's choice, not the C/TPA's--the employer may use the C/
TPA's mailing address in place of its own. Other employer information, 
such as name, telephone, and fax number, must remain on the CCF. The 
entry would read like this: Joe's Trucking

[[Page 41945]]

Company; Phone 202-555-5555; (fax) 202-555-5556; c/o CTPA's name and 
address.

Section 40.47  May Employers Use the CCF for Non-Federal Collections or 
Non-Federal Forms for DOT Collections?

    We have changed the word ``non-DOT'' to ``non-Federal'' to avoid 
confusion. The CCF is a joint DOT-HHS product that may be used for 
Federal drug testing programs subject to the HHS Mandatory Guidelines 
as well as to the DOT drug testing program.

Section 40.65  What Does the Collector Check for When the Employee 
Presents a Specimen?

    Section 40.65 (c)(3) describes a situation where an employee 
refuses to provide another specimen where required. The current rule 
requires the collector to first notify the DER and then discard the 
specimen. This procedure should be reversed, i.e., the collector should 
discard the specimen first and then notify the DER. Otherwise the 
collector, who may not be able to get hold of the DER right away, would 
have to retain the urine specimen until such time that the DER is 
contacted. Also the reference to Sec. 40.191(a)(3) is inappropriate for 
this paragraph and has been corrected to refer to Sec. 40.191(a)(4).

Section 40.67  When and How Is a Directly Observed Collection 
Conducted?

    Section 40.67(d)(2) directs the collector to ``explain to the 
employee the reason under this part for a directly observed collection 
under paragraph (c)(2) through (4) of this section.'' However, there is 
no paragraph (4). Additionally, paragraph (c)(1) should be included in 
the collector's explanation of why an observed collection is being 
conducted, i.e., because the employer required it; the employee, if not 
told by the employer, is certainly entitled to know this and the 
collector would have that information. A corrected reference is needed 
in paragraph (c)(1). Lastly, the collector will inform the employee of 
the reason for a direct observation collection if the collector knows 
the reason. If all the collector knows is that the employer ordered the 
direct observation collection, then that is all the information that 
the collector will be able to provide the employee.
    When a collector learns that a directly observed test should have 
occurred, but did not, it is the collector's responsibility to correct 
the omission. For example, suppose the initial specimen was out of 
temperature range, but the collector forgot to require a directly 
observed recollection. When the laboratory points out this problem to 
the collector, the collector would contact the employer. The employer, 
in turn, would contact the employee and direct the employee to undergo 
an immediate recollection under direct observation, even though some 
time may have passed since the original collection.

Section 40.69  How Is a Monitored Collection Conducted?

    There have been some questions as to whether or not we meant to 
change the meaning of ``medical professional'' mentioned at Sec. 40.69 
with respect to someone acting as a collection monitor. We did not. We 
still want doctors, nurses, and licensed medical technicians to be able 
to be monitors even if not the same gender, and we do not believe 
secretaries, receptionists, or records clerks are appropriate to 
perform this function (unless of the same gender as the donor). If 
there is any doubt about the qualifications of others, such as an 
Emergency Medical Technician or a phlebotomist, the ``litmus test'' 
would be whether or not that individual is licensed or certified to 
practice as a medical professional in a state (i.e., approved by state 
action). If they meet that requirement, they would be allowed to be 
opposite-gender monitors. In paragraph (c), we are correcting the 
language to refer to the ``monitor'' rather than the ``observer.''

Section 40.71  How Does the Collector Prepare the Specimens?

    Section 40.71 tells the collector how to prepare the specimen; it 
does not state what to do with any ``left over'' urine. There have been 
questions about the employee being able to take the ``excess'' urine 
with him/her, if any adulteration tests could be performed, or if any 
additional medical tests could be conducted on the excess specimen. 
This new paragraph clarifies these matters and incorporates an existing 
DOT interpretation that excess urine can be used in clinical urinalysis 
(e.g., specific gravity, protein, glucose) if the DOT specimen is 
collected in conjunction with a physical examination required by a DOT 
agency.

Section 40.73  How Is the Collection Process Completed?

    Paragraph (a)(9) of this section mentions that the collector must 
fax or otherwise transmit the appropriate CCF copies to the MRO and 
DER. While we do not believe a regulatory text is change is necessary 
to make the point, we want to clarify that we view documents sent by 
fax as originals for purposes of this section. For example, the 
collector may fax the MRO copy of the CCF to the MRO. Since the MRO now 
has what we regard as an original, the collector could discard the MRO 
copy 30 days later.

Section 40.83  How Do Laboratories Process Incoming Specimens?

    We have revised this section to clarify the handling of certain 
problems concerning collections. As provided in new Sec. 40.208 below, 
we are no longer requiring the cancellation of a test because the 
collector omitted checking the temperature box and did not include a 
comment concerning the omission in the remarks section of the CCF. 
While this error still must be corrected, we do not believe it is 
necessary to cancel the test, since this is an error that does not 
diminish the rule's protections for the fairness of the testing process 
to the employee.
    In addition, this section is changed be consistent with the 
clarification of the responsibilities of laboratories, C/TPAs and other 
parties to distribute and use only the new CCF. For three months, until 
the end of October 2001, use of expired ``old'' CCF, will not result in 
cancellation or rejection of a test, even if an appropriate correction 
is not made. Beginning November 1, the laboratory must report this 
situation (i.e., expired form used, correction not made) as ``rejected 
for testing'' with the appropriate remarks. We note that this change in 
timing applies only to use of the expired Federal CCF. When a non-
Federal form is used at any time, the error must be corrected or the 
test must be rejected.

Section 40.89  What Is Validity Testing, and Are Laboratories Required 
To Conduct It?

    When the Department published its final rule in December 2000, we 
anticipated that HHS would amend its Mandatory Guidelines for drug 
testing establishing final requirements for validity testing by HHS-
certified laboratories. HHS is continuing to work on this project, but 
the HHS amendment will not be published by August 1, 2001. The 
Department believes that it is advisable to wait until HHS has 
completed its amendment to make validity testing mandatory for all DOT 
specimens. Consequently, we are changing the language of paragraph (b) 
of this section to eliminate the requirement that laboratories conduct 
validity tests on each DOT specimen. In its place, we are inserting 
language from our existing regulation providing that laboratories are 
authorized to conduct validity testing. This means that no change in 
validity testing will take place on August 1, 2001. We will amend this

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section again to mandate validity testing when HHS issues its final 
amendment.

Section 40.97  What Do Laboratories Report and How Do They Report It?

    Current Sec. 40.97(a) limits reporting to one result. We have 
already seen incidents where multiple results can occur because of 
adulterants. Recently one laboratory had a confirmed cocaine positive, 
but an adulterant prevented the laboratory from obtaining a 
satisfactory result for marijuana (neither negative, positive or 
adulterated). The final result should have been ``positive--cocaine'' 
as well as ``invalid--with remark.'' By adding ``or more'' to the 
introductory text of paragraph (a), we are clarifying that it is proper 
to report such a multiple result.
    The changes to paragraph (b)(1)(i) and (2) are designed to clarify 
the information to be provided on an electronic results report. The MRO 
needs to know where the test was performed. Since some laboratories 
have multiple laboratory sites, a name of the laboratory on the 
electronic report will not suffice to identify where the test was 
performed. HHS has indicated that the MRO's name and the certifying 
scientist's name would help laboratory inspectors who will be comparing 
electronic results with CCFs. The MRO name is also needed to ensure 
that the report goes to the right person. The Certifying Scientist's 
name is also needed in case the MRO needs to contact the laboratory for 
additional information and communication. The collector's name and 
phone number are needed in case someone needs to contact the collector 
for information or to take corrective action. Laboratories have been 
utilizing electronic reports since the outset of the program. Many of 
these reports contain information that is not contained on the CCF--the 
``official `` report. Since it is likely that the electronic results 
report will replace the CCF for the majority of negative reports, 
additional information should no longer appear on the electronic 
report.

Section 40.121  Who Is Qualified To Act as an MRO?

    There have been questions about when the first round of CEU hours 
and refresher training are required for previously trained MROs and 
BATs/STTs, respectively. The Department did not intend to have people 
who had already met qualification training requirements to face an 
immediate CEU or refresher-training requirement as soon as the 
regulations went into effect. Therefore, we are clarifying this section 
to specify that all MROs who were trained and examined before August 1, 
2001 have until August 1, 2004 to complete their first round of CEUs. 
Likewise BATs/STTs who completed qualification training before January 
1, 1998 would have until January 1, 2003, to complete refresher 
training, and we have amended Sec. 40.213 to this effect.

Section 40.127  What Are the MRO's Functions in Reviewing Negative Test 
Results?

    We have corrected paragraph (g) by inserting the word ``perform,'' 
which had been omitted. We also added a sentence to provide 
instructions on how to complete the CCF when a negative result is 
canceled.

Section 40.129  What Are the MRO's Functions in Reviewing Laboratory 
Confirmed Positive, Adulterated, Substituted, or Invalid Test Results?

    The current Sec. 40.129 does not contain instructions on completing 
the CCF when the MRO cancels a positive, adulterated, substituted, or 
invalid drug test report. This amendment provides clarified 
instructions on how the MRO should complete the CCF in this 
circumstance.

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?

    We have been asked whether Sec. 40.131(d) means that the employee 
can contact the MRO at his or her leisure, just as long as it is within 
the next 72 hours. We are clarifying the provision to direct the 
employer to tell the employee to contact the MRO immediately. The 
employee would not violate the rule by not doing so, however. Of 
course, if the employee fails to contact the MRO within 72 hours, the 
MRO may declare the test a ``non-contact positive.'' This amendment 
would also direct the employer to warn the employee of this 
consequence.

Section 40.135  What Does the MRO Tell the Employee at the Beginning of 
the Verification Interview?

    Part 40 requires that MROs must report the use of any legally 
prescribed medication that could make the employee medically 
unqualified or pose a significant safety risk. Before doing so, 
however, this section tells MRO to contact the employee's physician to 
determine if the medication could be changed to one that does not make 
the employee unqualified to perform safety sensitive functions. We 
believe that it is likely to be easier and faster for the employee to 
contact his or her own physician and instruct that physician to contact 
the MRO. This would be more efficient than to require that the MRO 
repeatedly call the other physician. Employees can greatly assist the 
likelihood of this conversation by explaining their desire and 
motivation to their own treatment physician, and instructing that 
physician to contact the MRO on their behalf.
    In addition, because the employee's use of the medication can pose 
a safety problem immediately, we believe that the contact with the 
prescribing physician should occur after, rather than before, the 
provision of information to the employer. To facilitate this process, 
the revised paragraph (e) of this section gives the employee 5 days to 
have his or her physician contact the MRO for this purpose. If the 
prescribing physician comes up with a prescription that will obviate 
the safety problem, the MRO would so inform the employer.

Section 40.149  May the MRO Change a Verified Positive Test Result or 
Refusal To Test?

    The Department has received a number of questions about the 
provision of this section, which provides, in its present form, that 
the MRO is the only person authorized to change a verified test result. 
Most of the questions concerned the effect of this provision on the 
authority of arbitrators, grievance examiners, etc. to review test 
results.
    The Department makes the MRO the key person in determining the 
disposition of a non-negative laboratory result. The MRO is directed to 
bring his or her professional training and experience to bear on 
questions such as whether there is a legitimate medical explanation for 
a positive, adulterated, or substituted test result. The Department 
believes strongly that the medical judgment of the MRO on these 
questions should not be overturned by arbitrators, employers, or other 
participants in the drug testing program. Consequently, we have 
clarified paragraph (c) to emphasize that MROs have sole authority to 
make medical judgments about drug test results and that arbitrators and 
other participants in the system do not have authority to overturn 
these judgments.
    This is not to say that an arbitrator is precluded from requiring a 
test result to be canceled on other grounds (e.g., a fatal flaw in the 
chain of custody, the failure of the MRO to provide an opportunity for 
the employee to present evidence of an alleged legitimate medical 
explanation, the denial of the right to have a split specimen tested). 
But an arbitrator could not decide, in the face of an MRO's judgment 
that

[[Page 41947]]

there was not a legitimate medical explanation, that the employee had 
presented a legitimate medical explanation. This rule is intended to 
prevent such a substitution of judgment about a matter committed to the 
expertise of the MRO.

Section 40.151  What Are MROs Prohibited From Doing as Part of the 
Verification Process?

    Despite a clear explanation of the present Sec. 40.151(b) in the 
preamble, some MROs have misunderstood the present provision to be more 
sweeping than intended, and to constitute a sort of gag rule on MROs 
concerning contacts with collectors. The objective of this provision is 
not to preclude discussions between MROs and collectors. It is to 
protect MROs from being cast in the role of judge and jury in ``he 
said/she said'' disputes between employees about what occurred during 
the collection.
    For example, suppose the employee tells the MRO that the collector 
left the open collection container unguarded and unobserved in a public 
space. The collector just as strongly denies the allegation. The MRO is 
not in a good position to evaluate the facts of the dispute or the 
credibility of the employee and collector. That is a function best left 
to other decisionmakers, such as arbitrators or the courts. Based on 
language in the final rule's preamble, paragraph (b) has been rewritten 
to focus on this point. Note that this paragraph focuses on disputes: 
nothing in the paragraph precludes an MRO from taking corrective action 
in a situation in which it is undisputed that an error took place 
(e.g., the collector and employee agree that a mistake requiring 
correction was made).

Section 40.155  What Does the MRO Do When a Negative or Positive Test 
Result Is Also Dilute?

    The current 40.155(c) instructs MROs in handling dilute test 
results--both positive and negative. Laboratories are provided 
instructions for reporting two categories of test results in 40.97--
negative results and non-negative results. The requirements of 
40.155(c) treat a negative-dilute result as a non-negative result (by 
requiring that the MRO receive Copy 1 from the laboratory). A negative-
dilute result is still a negative result and to change the laboratory 
reporting requirements may connote undue suspicion on the result. The 
Department places negative and negative-dilute test results in the 
negative reporting category. All other results are considered non-
negative. Effective and efficient notification can be made to the 
employer for a negative-dilute result in the same manner that 
notification is made for a negative result. Any further action on a 
negative-dilute (see Sec. 40.197) would be a function of the employer's 
policy.

Section 40.163  How Does the MRO Report Drug Test Results?

    Commenters on the Part 40 proposed rule advocated greater use of 
electronic means to transmit negative results from MROs to employers. 
In the final rule preamble, we said that we agreed. One area in which 
greater reliance on electronic methods appears workable is the 
treatment of negative test reporting in this section.
    Allowing for electronic reporting of negatives by MROs is 
consistent with the direction in which we have headed allowing more 
utilization of electronic capabilities (e.g., 40.97) by laboratories. 
However, current Sec. 40.163 does not specifically allow anything 
special for electronic reports for negatives as the preamble suggested 
we favored; in fact, reporting requirements in current Sec. 40.163 
reference all reports being ``in writing.'' We have modified this 
section to remove this obstacle to electronic reporting of negatives.
    A related change involves duplicate instructions of Secs. 40.127 
and 40.163. Currently, both require MRO to initial or sign the CCF. The 
second initial/signing has been removed from Sec. 40.163.

Section 40.167  How Are MRO Reports of Drug Results Transmitted to 
Employers?

    The Department is revising paragraph (c) of this section to clarify 
reporting requirements in view of the greater authorization for 
electronic reporting of negative results. In addition, we are adding a 
new paragraph (e) to parallel the prohibition of reversals of MROs 
medical judgments as provided in Sec. 40.149(c).

Section 40.187  What Does the MRO Do With Split Specimen Laboratory 
Results?

    The Department is adding two new paragraphs to this section to fill 
gaps that have been called to our attention since we published the 
final rule. The first is a situation in which, for example, the primary 
specimen tests positive for a drug but the split specimen test is 
invalid (see new paragraph (e)). In this case (parallel to the 
situation in which the split specimen is unavailable for testing) the 
test is cancelled and the employer must require the employee to undergo 
an immediate recollection under direct observation.
    The second is a hopefully rare situation in which the primary 
specimen tests positive for a drug, and the split specimen does not 
reconfirm the presence of the drug but the laboratory determines that 
an adulterant is present (see new paragraph (f)). In this case, we do 
not have a reconfirmed positive drug test. On the other hand, we do 
have a laboratory finding that, were it made with respect to the 
primary specimen, would be the basis of a refusal result.
    We do not believe it is sound policy, and consistent with our 
safety objectives, to ignore this adulteration result. On the other 
hand, we believe it is important to provide appropriate due process 
protections for employees in this situation. Consequently, the MRO will 
contact the employee and ask whether there is any legitimate medical 
explanation for the presence of the adulterant in the split specimen. 
If there is a legitimate medical explanation, the entire test is 
cancelled. If not, the MRO reports the test to the employee and DER as 
a refusal. The employee will have 72 hours to request a test of the 
primary specimen to determine if the adulterant is present there as 
well. Except that this is a test of the primary specimen, taking place 
at the laboratory that originally tested the primary specimen, this 
test is intended to parallel the testing of the split specimen in the 
more usual type of case. If the test of the primary specimen reconfirms 
the presence of the adulterant found in the split specimen, then the 
refusal result is reconfirmed. If not, then the test is cancelled and 
the ``split invalid'' procedure of paragraph (e) applies.

Section 40.191  What Is a Refusal To Take a DOT Drug Test, and What Are 
the Consequences?

    In paragraph (a) of this section, we are making a number of changes 
to clarify the application of the refusal provisions of the rule to 
pre-employment testing. In the case of pre-employment testing, it is 
very possible for applicants to fail to appear for a test for a number 
of legitimate reasons (e.g., took another job, decided they did not 
want to change their present job, decided they didn't want to work for 
a particular employer). In this situation, we believe it would be 
unfair to visit the consequences of a refusal (e.g., having to complete 
the return-to-duty process, certificate actions under some DOT agency 
regulations) on the applicant (Sec. 40.191(a)(1)).
    For example, suppose someone has applied to both Company A and 
Company B for a job. Both companies tell him that they want to offer 
him a

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job, but that he will have to have a pre-employment test before they 
can actually hire him. Each company schedules the employee for a pre-
employment test. Before the tests occur, the employee decides that 
since Company A will pay him more, he prefers to work for Company A. He 
takes the pre-employment test scheduled by Company A, but not the one 
scheduled by Company B, since he is no longer interested in working for 
Company B. In this situation, we would not view the individual as 
having refused a test by not having attended Company B's scheduled 
test. In addition, in the pre-employment test context, there can be 
situations in which an employee could legitimately leave a collection 
site before the test actually commences (e.g., there is a long wait for 
the test and the employee has another obligation). By the commencement 
of the test, we mean the actions listed in Sec. 40.63(c), in which the 
collector or employee selects a collection container. Once the 
collection has commenced, the donor has committed to the process, and 
must complete it. If the employee then leaves before the process is 
complete, or takes another action listed in this section as a refusal, 
the consequences of a refusal attach. However, if the employee leaves 
the site before the test commences, then the employee is in the same 
situation as someone who does not appear at all for the pre-employment 
test. The consequences of a refusal do not attach in this situation 
(Sec. 40.191(a)(2) and (3)).
    If a medical evaluation or examination is required as part of a 
pre-employment drug test process, the requirement could raise questions 
of consistency with the employment provisions of the Americans with 
Disabilities Act, as implemented by Equal Employment Opportunity 
Commission (EEOC) regulations and guidance. It is not the drug test 
itself that raises these issues, only the medical examination or 
evaluation that follows it (e.g., in the context of a ``shy bladder'' 
situation). To avoid raising ADA issues, we have added a sentence 
providing that an employee is deemed to have refused to test on the 
basis of not undergoing such an examination only if the pre-employment 
test is conducted following a contingent offer of employment 
(Sec. 40.191(a)(7)).
    We are also making two minor changes to this section. In paragraph 
(a)(1), we are adding a reference to consistency with DOT agency drug 
regulations, which may establish time frames for sending employees for 
random or other tests. In paragraph (d), we have deleted a potentially 
confusing reference to use of a separate document and clarify that the 
employee's name should be entered on Copy 2 of the CCF.
    We also note that there may be a few situations in which an 
employee may legitimately not go the collection site for a pre-
employment test.

Section 40.193  What Happens When an Employee Does Not Provide a 
Sufficient Amount of Urine for a Drug Test?

    For consistency with other parts of the rule, we have deleted the 
word ``working'' from the phrase ``five working days.'' We have also 
added a requirement to document on the CCF the time at which the three-
hour period to drink fluids begins and ends in a ``shy bladder'' 
situation. The intent of this requirement is to avoid questions about 
whether the proper amount of time was given to the employee. If the 
collector omits this information, it does not result in the 
cancellation of the test (see Sec. 40.209). We have also clarified the 
rule by saying that an employee who leaves the collection site before 
the ``shy bladder'' collection process is complete has refused to test.

Section 40.195  What Happens When an Individual Is Unable To Provide a 
Sufficient Amount of Urine for a Pre-Employment, Follow-Up, or Return-
to Duty Test Because of a Permanent or Long-term Medical Condition?

    We have added follow-up tests to this provision since they, like 
pre-employment and return-to-duty tests, require employees to have a 
negative test result in order to meet regulatory requirements for 
safety-sensitive employment.

Section 40.203  What Problems Cause a Drug Test To Be Cancelled Unless 
They Are Corrected?

    There are two changes to this section. We are no longer treating 
the failure of the collector to check the temperature box and to 
annotate the remarks section concerning temperature as a flaw that 
results in cancellation unless it is corrected. This is still an error 
in the collection that needs to be corrected (see Sec. 40.208 below), 
but it is not a mistake that undermines the protections afforded the 
employee. Checking the temperature is important as a means of detecting 
attempts to adulterate or substitute the specimen, but omitting this 
step does not make the process less fair for the employee.
    The second change underlines the importance of using the new CCF, 
which becomes mandatory on August 1, 2001. Beginning on that date, the 
old Federal CCF will have expired, and its use is no longer authorized. 
It will have the same status as a non-Federal form. That is, if a non-
Federal or expired Federal form is used for a test, the test must be 
cancelled unless the error is corrected as provided in Sec. 40.205. We 
are concerned about reports that, almost a year after use of the new 
form was authorized, many employers and collection sites are having 
difficulty obtaining copies of the new CCF from their laboratories and/
or C/TPAs. We are providing a 90-day grace period during which the 
failure to correct the use of an obsolete Federal form will not result 
in the cancellation of a test. After that, participants who fail to 
correct the use of the expired Federal form will bear the consequences 
of a cancelled test.

Section 40.205  How Are Drug Test Problems Corrected?

    We have amended paragraph (b)(2) to specify that this correction 
procedure applies to the use of expired Federal forms as well as to 
non-Federal forms. The content of the correction document has also been 
clarified.

Section 40.208  What Problem Requires Corrective Action But Does Not 
Result in the Cancellation of a Test?

    This is a new section focusing on the temperature box checkoff 
issue described in connection with Sec. 40.203 above. This section 
requires correction of the error (i.e., through an MFR). However, the 
error does not result in the cancellation of a test. When a collector 
makes this error, the collector is not required to undergo error 
correction training. However, the employer, C/TPA, collection site, 
etc. responsible for the collector should take appropriate steps to 
ensure that the collector does not repeat the mistake.

Section 40.209  What Procedural Problems Do Not Result in the 
Cancellation of a Test and Do Not Require Corrective Action?

    We have modified the title of this section to avoid confusion with 
the title of new Sec. 40.208. We also have added reference to service 
agents as a party who are subject to potential consequences for errors 
that do not result in the cancellation of tests, through the ``PIE'' 
provisions of Subpart R of the rule.

Section 40.213  What Training Requirements Must STTs and BATs Meet?

    The final rule inadvertently changed the number of mock tests BAT 
and STT trainees had to complete. We have amended this section to 
maintain the status quo with respect to the testing

[[Page 41949]]

requirements established by the DOT Model Course. In addition, to avoid 
requiring some previously trained BATs and STTs to complete refresher 
training too quickly, we have added a sentence saying individuals 
trained before January 1, 1998, have until January 1, 2003, to get 
refresher training.

Section 40.225  What Form Is Used for an Alcohol Test?

    To make the transition to use of the new alcohol testing form 
easier, we are making use of the new ATF mandatory as of February 1, 
2002. Use of the new form is authorized now. To maintain consistency 
between use of the old form and the instructions in new Part 40, 
employees should be asked to sign Statement 4 only if their test result 
is .02 or higher. We have also modified paragraph (b)(4) to clarify 
that there are a number of options for the coloring of ATFs.

Section 40.229  What Devices Are Used To Conduct Alcohol Screening 
Tests?

    Only alcohol screening devices (ASDs) on the National Highway 
Traffic Safety Administration's Conforming Products List (CPL) may be 
used for DOT alcohol screening tests. This is a necessary, but not 
sufficient, condition for using an ASD. It is possible that there may 
be devices added to the CPL that do not have instructions for their use 
incorporated in Part 40. Until and unless instructions for properly 
using the device in the context of DOT alcohol testing appear in Part 
40, it is not permissible to use such a device for DOT alcohol tests. 
The Department is adding a sentence to this section making this point 
explicit.

Section 40.253  What Are the Procedures for Conducting an Alcohol 
Confirmation Test?

    We have substituted the word ``unique'' for the word ``sequential'' 
to avoid any unnecessary conflict with EBTs that may not, as such, 
provide sequential numbers. Unique numbers for each test, even if not 
sequential, provide sufficient identification of the test.

Section 40.261  What Is Refusal To Take an Alcohol Test, and What Are 
the Consequences?

    We have modified Sec. 40.261(a)(1)-(3) to be consistent with 
Sec. 40.191, with respect to refusals of pre-employment tests.

Section 40.281  Who Is Qualified To Act as a SAP?

    In the final rule's preamble discussion concerning qualification 
training for substance abuse professionals (SAPs), the Department 
commented that ``* * * the Department does not believe that this 
examination needs to be a formally designed and validated 
examination,'' suggesting that the examination could be simpler than 
the examinations administered by existing MRO training groups (65 FR 
79507). In discussions with participants in the drug and alcohol 
testing program, this approach has been questioned. As a result of this 
discussion, we have re-thought this position. No regulatory text 
changes are needed as a result of this change in our thinking.
    It is now the Department's policy that a nationally-recognized SAP 
training organization that constructs an examination should have the 
examination validated by an outside test evaluation organization (as 
MRO groups have done for their tests) or by an effective peer review. 
The validation process would include a discussion of test items, areas 
of knowledge tested, and the effectiveness with which the test items 
measure the areas of knowledge involved. It should also include a 
psychometric review that evaluates how the items and questions are 
structured. The review should suggest modifications to the examination, 
if needed, to improve its quality.
    We emphasize that we are not requiring that an outside organization 
actually develop, administer, score, or grade the test, but simply 
review and evaluate the examination to make sure it was a good measure 
of what SAP trainees are supposed to learn. For this reason, we believe 
the cost of the process is modest. The information we have learned from 
sources in the testing business suggests that one could expect a review 
of the kind we envision for around $10,000.

Section 40.329  What Information Must Laboratories, MROs, and Other 
Service Agents Release to Employees?

    Part 40 requires a Substance Abuse Professional (SAP) to provide an 
employee, upon request, a copy of SAP reports. We have heard concerns 
expressed by SAPs and employers that providing a report containing the 
follow-up testing plan will give the employee the number and frequency 
of follow-up testing. We do not believe that an employee returning to 
duty following a rule violation should have access to the follow-up 
testing plan, which could lessen the deterrent effect of follow-up 
tests. Therefore, we are directing SAPs to remove follow-up testing 
information from SAP reports they provide to employees.

Section 40.331  To What Additional Parties Must Employers and Service 
Agents Release Information?

    The Department is concerned that DOT agency representatives may not 
be able to effectively inspect or audit electronically stored records, 
data, and information. Therefore, the Department will require that all 
records and data be presented in such a way that they can be easily 
reviewed. If electronic records do not meet this ``auditable'' 
standard, the electronic documentation must be changed into printed 
format. This is a reasonable requirement to impose on employers and 
other parties who take advantage of the greater flexibility and cost 
savings provided by opportunities for electronic data management 
permitted under Part 40. In addition, to avoid any possible confusion, 
we have specifically directed both employers and service agents to meet 
DOT agency timing requirements for production of records to inspectors 
or other DOT officials (e.g., two business days for FMCSA).

Section 40.333  What Records Must Employers Keep?

    We have received questions asking whether the regulation is 
intended to require the retention of information concerning blind as 
well as employee specimens. We do intend for blind specimen records to 
be retained. To avoid potential uncertainty on this point, we have 
removed the word ``employee'' from paragraphs (a)(1)(i) and (ii) of 
this section, so that the language refers to all specimens. We have 
also added a new paragraph (e), which parallels the language discussed 
under Sec. 40.331 above concerning ``auditable'' electronic records.

Section 40.349  What Records May a Service Agent Receive and Maintain?

    We made this change for terminological consistency with 
Sec. 40.333(d).

Section 40.355  What Limitations Apply to the Activities of Service 
Agents?

    One of the limitations on service agent activities is a prohibition 
on requiring employees to sign consents, waivers etc. We have added a 
sentence to this paragraph to specify that no one else (e.g., an 
employer) can do so for the service agent. In addition, in response to 
comments on the DOT agency

[[Page 41950]]

conforming rules, we have deleted the requirement for DOT agency rule 
authorization for C/TPAs to declare a refusal in the case of an owner-
operator who fails to appear for a test.

Section 40.403  Must a Service Agent Notify Its Clients When the 
Department Issues a PIE?

    We made this change for terminological consistency with other 
provisions of the rule.

Appendix F

    We have added a few sections to the drug testing information list 
in this appendix to correspond to other changes we have made in Part 40 
or to correct earlier omissions.

Regulatory Notices and Analyses

    This rule is a non-significant rule both for purposes of Executive 
Order 12886 and the Department of Transportation's Regulatory Policies 
and Procedures. The Department certifies that it will not have a 
significant economic effect on a substantial number of small entities, 
for purposes of the Regulatory Flexibility Act. The Department makes 
these statements on the basis that, as a series of technical amendments 
that correct or clarify existing regulatory provisions, this rule will 
not impose any significant costs on anyone. The costs of the underlying 
Part 40 final rule were analyzed in connection with its issuance in 
December 2000. Therefore, it has not been necessary for the Department 
to conduct a regulatory evaluation or Regulatory Flexibility Analysis 
for this final rule.
    This rule imposes no information collection requirements for which 
Paperwork Reduction Act approval is needed. It has no Federalism 
impacts that would warrant a Federalism assessment. The amendments made 
in this rule are technical, corrective, and clarifying changes to an 
existing rule that went through an extensive public notice and comment 
process. The amendments do not make significant substantive changes to 
Part 40, and we would not anticipate the receipt of meaningful comments 
on them. However, it is essential that these technical amendments take 
effect on August 1, 2001, with the rest of the new Part 40. Delaying 
these amendments for a prior comment period would be unnecessary and 
contrary to the public interest, as it would result in participants 
having to implement an uncorrected version of the rule and then make 
changes in the midst of implementing the new rule. For the same 
reasons, the Department has good cause to make the changes effective in 
less than 30 days.

List of Subjects in 49 CFR Part 40

    Administrative practice and procedure, Alcohol abuse, Alcohol 
testing, Drug abuse, Drug testing, Reporting and recordkeeping 
requirements, Safety, Transportation.

    Issued this 24th day of July, 2001, at Washington, DC.
Norman Y. Mineta,
Secretary of Transportation.

    For the reasons set forth in the preamble, the Department of 
Transportation amends 49 CFR Part 40 as follows:

PART 40--PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL 
TESTING PROGRAMS

    1. The authority citation for 49 CFR Part 40 continues to read as 
follows:

    Authority: 49 U.S.C. 102, 301, 322, 5331, 20140, 31306, and 
45101 et seq.

    2. Amend Sec. 40.3 as follows:
    a. In the definition of ``Designated employer representative 
(DER)'', add the words ``, or cause employees to be removed from these 
covered duties,'' after the word ``duties'';
    b. Add a definition of ``Invalid drug test'' in alphabetical order 
to read as follows:


Sec. 40.3  What do the terms used in this regulation mean?

* * * * *
    Invalid drug test. The result of a drug test for a urine specimen 
that contains an unidentified adulterant or an unidentified interfering 
substance, has abnormal physical characteristics, or has an endogenous 
substance at an abnormal concentration that prevents the laboratory 
from completing or obtaining a valid drug test result.
* * * * *

    3. In subpart B, redesignate Sec. 40.27 as Sec. 40.29, and add a 
new Sec. 40.27, to read as follows:


Sec. 40.27  May an employer require an employee to sign a consent or 
release in connection with the DOT drug and alcohol testing program?

    No, as an employer, 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).


Sec. 40.33  [Amended]

    4. Amend Sec. 40.33 (c)(2) introductory test, in the second 
sentence, to remove the words ``an individual'' and add in their place 
the words ``a qualified collector''.

    5. Amend Sec. 40.45 as follows:
    a. In paragraph (a), revise the HHS web site address ``(http://www.health.org/workpl.htm)'' to read ``(http://www.workplace.samhsa.gov)''.
    b. Redesignate paragraphs (b), (c), and (d), as paragraphs (c), 
(d), and (e), respectively.
    c. Add a new paragraph (b).
    d. Add a sentence at the end of newly redesignated paragraph (c)(2) 
to read as follows:


Sec. 40.45  What form is used to document a DOT urine collection?

* * * * *
    (b) You must not use a non-Federal form or an expired Federal form 
to conduct a DOT urine collection. As a laboratory, C/TPA or other 
party that provides CCFs to employers, collection sites, or other 
customers, you must not provide copies of an expired Federal form to 
these participants. You must also affirmatively notify these 
participants that they must not use an expired Federal form (e.g., that 
beginning August 1, 2001, they may not use the old 7-part Federal CCF 
for DOT urine collections).
    (c) * * *
    (2) * * * The employer may use a C/TPA's address in place of its 
own, but must continue to include its name, telephone number, and fax 
number.
* * * * *


Sec. 40.47  [Amended]

    6. Amend Sec. 40.47 by removing the word ``non-DOT'' and adding in 
its place the word ``non-Federal'' in the heading of the section, in 
paragraph (a), and in paragraph (b)(2).

    7. Amend Sec. 40.65 by revising paragraph (c)(3) to read as 
follows:


Sec. 40.65  What does the collector check for when the employee 
presents a specimen?

* * * * *
    (c) * * *
    (3) In a case where the employee refuses to provide a specimen 
under direct observation (see Sec. 40.191(a)(4)), you must discard any 
specimen the employee provided previously during the collection 
procedure. Then you must notify the DER as soon as practicable.

    8. Amend Sec. 40.67 by revising paragraphs (c)(1) and (d)(2) and 
adding a new paragraph (m), to read as follows:

[[Page 41951]]

Sec. 40.67  When and how is a directly observed collection conducted?

* * * * *
    (c) * * *
    (1) You are directed by the DER to do so (see paragraphs (a) and 
(b) of this section); or
* * * * *
    (d) * * *
    (2) As the collector, you must explain to the employee the reason, 
if known, under this part for a directly observed collection under 
paragraphs (c)(1) through (3) of this section.
* * * * *
    (m) As the collector, when you learn that a directly observed 
collection should have been collected but was not, you must inform the 
employer that it must direct the employee to have an immediate 
recollection under direct observation.

    9. Amend Sec. 40.69 by revising paragraphs (b) and (c) to read as 
follows:


Sec. 40.69  How is a monitored collection conducted?

* * * * *
    (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, technologist, or 
technician licensed or certified to practice in the jurisdiction in 
which the collection takes place). 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 the procedures of paragraphs (d) and (e) 
of this section. If you, the collector, are the monitor, you must 
follow these procedures.
* * * * *

    10. Amend Sec. 40.71 by adding a new paragraph (b)(8), to read as 
follows:


Sec. 40.71  How does the collector prepare the specimens?

* * * * *
    (b) * * *
    (8) You must discard any urine left over in the collection 
container after both specimen bottles have been appropriately filled 
and sealed. There is one exception to this requirement: you may use 
excess urine to conduct clinical tests (e.g., protein, glucose) if the 
collection was conducted in conjunction with a physical examination 
required by a DOT agency regulation. Neither you nor anyone else may 
conduct further testing (such as adulteration testing) on this excess 
urine and the employee has no legal right to demand that the excess 
urine be turned over to the employee.

    11. Amend Sec. 40.83 by revising paragraphs (e) and (f); 
redesignating paragraphs (g) and (h) as paragraphs (h) and (i), 
respectively; and adding a new paragraph (g) to read as follows:


Sec. 40.83  How do laboratories process incoming specimens?

* * * * *
    (e) You must inspect each CCF for the presence of the collector's 
signature on the certification statement in Step 4 of the CCF. Upon 
finding that the signature is omitted, 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 Sec. 40.205(b)(1).
    (3) If the flaw is not corrected, report the result as rejected for 
testing in accordance with Sec. 40.97(a)(3).
    (f) If you determine that the specimen temperature was not checked 
and the ``Remarks'' line did not contain an entry regarding the 
temperature being outside of range, you must then attempt to correct 
the problem by following the procedures of Sec. 40.208.
    (1) In such a case, you must continue your efforts to correct the 
problem for five business days, before you report the result.
    (2) When you have obtained the correction, or five business days 
have elapsed, report the result in accordance with Sec. 40.97(a).
    (g) If you determine that a CCF that fails to meet the requirements 
of Sec. 40.45(a) (e.g., a non-Federal form or an expired Federal form 
was used for the collection), you must attempt to correct the use of 
the improper form by following the procedures of Sec. 40.205(b)(2).
    (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 problem.
    (2) During the period August 1-October 31, 2001, you are not 
required to reject a test conducted on an expired Federal CCF because 
this problem is not corrected. Beginning November 1, 2001, if the 
problem(s) is not corrected, you must reject the test and report the 
result in accordance with Sec. 40.97(a)(3).
* * * * *


Sec. 40.89  [Amended]

    12. Amend Sec. 40.89(b) by removing the word ``must'' and adding in 
its place the words ``are authorized to''.

    13. Amend Sec. 40.97 by revising the introductory text of paragraph 
(a) and paragraphs (b)(1)(i) and (b)((1)(ii) to read as follows:


Sec. 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 or more of the following:
* * * * *
    (b) * * *
    (1) * * *
    (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 and address;
    (B) Employer's name (you may include I.D. or account number);
    (C) Medical review officer's name;
    (D) Specimen I.D. number;
    (E) Donor's SSN or employee I.D. number, if provided;
    (F) Reason for test, if provided;
    (G) Collector's name and telephone number;
    (H) Date of the collection;
    (I) Date received at the laboratory;
    (J) Date certifying scientist released the results;
    (K) Certifying scientist's name;
    (L) Results (e.g., positive, adulterated) as listed in paragraph 
(a) of this section; and
    (M) Remarks section, with an explanation of any situation in which 
a correctable flaw has been corrected.
    (ii) You may release the laboratory results report only after 
review and approval by the certifying scientist. It must reflect the 
same test result information as contained on the CCF signed by the 
certifying scientist. The information contained in the laboratory 
results report may not contain information that does not appear on the 
CCF.
* * * * *

    14. Amend Sec. 40.121 by adding a new paragraph (d)(3), to read as 
follows:


Sec. 40.121  Who is qualified to act as an MRO?

* * * * *
    (d) * * *
    (3) If you are an MRO who completed the qualification training and 
examination requirements prior to August 1, 2001, you must complete 
your first increment of 12 CEU hours before August 1, 2004.
* * * * *

    15. Amend Sec. 40.127 by revising the introductory text of 
paragraph (g) to read as follows:


Sec. 40.127  What are the MRO's functions in reviewing negative test 
results?

* * * * *

[[Page 41952]]

    (g) Staff under your direct, personal supervision may perform the 
administrative functions of this section for you, but only you can 
cancel a test. If you cancel a laboratory-confirmed negative result, 
check the ``Test Cancelled'' box (Step 6) on Copy 2 of the CCF, make 
appropriate annotation in the ``Remarks'' line, provide your name, and 
sign, initial or stamp and date the verification statement.
* * * * *

    16. Amend Sec. 40.129 by redesignating paragraphs (d), (e), and (f) 
as paragraphs (e), (f), and (g) respectively, and by adding a new 
paragraph (d), to read as follows:


Sec. 40.129  What are the MRO's functions in reviewing laboratory 
confirmed positive, adulterated, substituted, or invalid test results?

* * * * *
    (d) If you cancel a laboratory confirmed positive, adulterated, 
substituted, or invalid drug test report, check the ``test cancelled'' 
box (Step 6) on Copy 2 of the CCF, make appropriate annotation in the 
``Remarks'' line, sign, provide your name, and date the verification 
statement.
* * * * *

    17. Amend Sec. 40.131 by revising the introductory text of 
paragraph (d) to read as follows:


Sec. 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?

* * * * *
    (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 should 
contact the MRO immediately. You must also inform the employee of the 
consequences of failing to contact the MRO within the next 72 hours 
(see Sec. 40.133(a)(2)).
* * * * *

    18. Amend Sec. 40.135 by revising paragraph (e) to read as follows:


Sec. 40.135  What does the MRO tell the employee at the beginning of 
the verification interview?

* * * * *
    (e) You must also advise the employee that, after informing any 
third party about any medication the employee is using pursuant to a 
legally valid prescription under the Controlled Substances Act, you 
will allow 5 days for the employee to have the prescribing physician 
contact you 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. If, as an MRO, you receive such information 
from the prescribing physician, you must transmit this information to 
any third party to whom you previously provided information about the 
safety risks of the employee's other medication.

    19. Amend Sec. 40.149 by revising paragraph (c) to read as follows:


Sec. 40.149  May the MRO change a verified positive test result or 
refusal to test?

* * * * *
    (c) You are the only person permitted to change a verified test 
result, such as a verified positive test result or a determination that 
an individual has refused to test because of adulteration or 
substitution. This is because, as the MRO, you have the sole authority 
under this part to make medical determinations leading to a verified 
test (e.g., a determination that there was or was not a legitimate 
medical explanation for a laboratory test result). For example, an 
arbitrator is not permitted to overturn the medical judgment of the MRO 
that the employee failed to present a legitimate medical explanation 
for a positive, adulterated, or substituted test result of his or her 
specimen.

    20. Amend Sec. 40.151 by revising paragraph (b) to read as follows:


Sec. 40.151  What are MROs prohibited from doing as part of the 
verification process?

* * * * *
    (b) It is not your function to make decisions about factual 
disputes between the employee and the collector concerning matters 
occurring at the collection site that are not reflected on the CCF 
(e.g., concerning allegations that the collector left the area or left 
open urine containers where other people could access them).
* * * * *


Sec. 40.155  [Amended]

    21. Amend Sec. 40.155 by removing paragraph (c) and redesignating 
paragraph (d) as new paragraph (c).

    22. Revise Sec. 40.163 to read as follows:


Sec. 40.163  How does the MRO report drug test results?

    (a) As the MRO, it is your responsibility to report all drug test 
results to the employer.
    (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, if indicated on the CCF (e.g., random, 
post-accident);
    (4) Date of the collection;
    (5) Date you received Copy 2 of the CCF;
    (6) Result of the test (i.e., positive, negative, dilute, refusal 
to test, test cancelled) and the date the result was verified by the 
MRO;
    (7) For verified positive tests, the drug(s)/metabolite(s) for 
which the test was positive;
    (8) For cancelled tests, the reason for cancellation; and
    (9) 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) As an exception to the reporting requirements of paragraph (b) 
and (c) of this section, the MRO may report negative results using an 
electronic data file.
    (1) If you report negatives using an electronic data file, the 
report must contain, as a minimum, the information specified in 
paragraph (c) of this section, as applicable for negative test results.
    (2) In addition, the report must contain your name, address, and 
phone number, the name of any person other than you reporting the 
results, and the date the electronic results report is released.
    (e) 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. If you 
use the electronic data file to report negatives, you must maintain a 
retrievable copy of that report in a format suitable for inspection and 
auditing by a DOT representative.
    (f) You must not use Copy 1 of the CCF to report drug test results.
    (g) 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 
Sec. 40.293(g)).

[[Page 41953]]


    23. Amend Sec. 40.167 by revising the section heading and paragraph 
(c), and adding a new paragraph (e), to read as follows:


Sec. 40.167  How are MRO reports of drug results transmitted to the 
employer?

* * * * *
    (c) You must transmit the MRO's report(s) of verified tests to the 
DER so that the DER receives it within two days of verification by the 
MRO.
    (1) You must fax, courier, mail, or electronically transmit a 
legible image or copy of either the signed or stamped and dated Copy 2 
or the written report (see Sec. 40.163(b) and (c)).
    (2) Negative results reported electronically (i.e., computer data 
file) do not require an image of Copy 2 or the written report.
* * * * *
    (e) MRO reports are not subject to modification or change by anyone 
other than the MRO, as provided in Sec. 40.149(c).

    24. Amend Sec. 40.187 by redesignating paragraphs (e) and (f) as 
paragraphs (g) and (h), respectively, and adding new paragraphs (e) and 
(f), to read as follows:


Sec. 40.187  What does the MRO do with split specimen laboratory 
results?

* * * * *
    (e) Failed to Reconfirm: Specimen Results Invalid. (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) Using the format in Appendix D to this part, notify ODAPC of 
the failure to reconfirm.
    (f) Failed to Reconfirm: Split Specimen Adulterated. (1) Contact 
the employee and inform the employee that the laboratory has determined 
that his or her split specimen is adulterated.
    (2) Follow the procedures of Sec. 40.145 to determine if there is a 
legitimate medical explanation for the laboratory finding of 
adulteration.
    (3) If you determine that there is a legitimate medical explanation 
for the adulterated test result, report to the DER and the employee 
that the test is cancelled. Using the format in Appendix D to this 
part, notify ODAPC of the result.
    (4) If you determine that there is not a legitimate medical 
explanation for the adulterated test result, take the following steps:
    (i) Report the test to the DER and the employee as a verified 
refusal to test. Inform the employee that he or she has 72 hours to 
request a test of the primary specimen to determine if the adulterant 
found in the split specimen also is present in the primary specimen.
    (ii) Except that the request is for a test of the primary specimen 
and is being made to the laboratory that tested the primary specimen, 
follow the procedures of Secs. 40.153, 40.171, 40.173, 40.179, and 
40.185.
    (iii) As the laboratory that tests the primary specimen to 
reconfirm the presence of the adulterant found in the split specimen, 
report your result to the MRO on a photocopy (faxed, mailed, scanned, 
couriered) of Copy 1 of the CCF .
    (iv) If the test of the primary specimen reconfirms the 
adulteration finding of the split specimen, as the MRO you must report 
the test result as a refusal as provided in Sec. 40.187(a)(2).
    (v) If the test of the primary specimen fails to reconfirm the 
adulteration finding of the split specimen, as the MRO you cancel the 
test. Follow the procedures of paragraph (e) of this section in this 
situation.
* * * * *

    25. Amend Sec. 40.191 by revising paragraphs (a)(1), (2), (3), and 
(7) and the introductory text of paragraph (d), to read as follows as 
follows:


Sec. 40.191  What is a refusal to take a DOT drug test, and what are 
the consequences?

    (a) * * *
    (1) Fail to appear for any test (except a pre-employment test) 
within a reasonable time, as determined by the employer, consistent 
with applicable DOT agency regulations, 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 a C/TPA (see 
Sec. 40.61(a));
    (2) Fail to remain at the testing site until the testing process is 
complete; Provided, That an employee who leaves the testing site before 
the testing process commences (see Sec. 40.63 (c)) for a pre-employment 
test is not deemed to have refused to test;
    (3) Fail to provide a urine specimen for any drug test required by 
this part or DOT agency regulations; Provided, That an employee who 
does not provide a urine specimen because he or she has left the 
testing site before the testing process commences (see Sec. 40.63 (c)) 
for a pre-employment test is not deemed to have refused to test;
* * * * *
    (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 under Sec. 40.193(d). In the case of a pre-employment drug 
test, the employee is deemed to have refused to test on this basis only 
if the pre-employment test is conducted following a contingent offer of 
employment; or
* * * * *
    (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 (including, in 
the case of the collector, printing the employee's name on Copy 2 of 
the CCF), 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.
* * * * *

    26. Amend Sec. 40.193 as follows:
    a. Revise paragraphs (b)(2) and (b)(3)
    b. In paragraph (c) introductory text, remove the word ``working'' 
before the word ``days''.
    c. Add and reserve paragraph (c)(2). The revisions read as follows:


Sec. 40.193  What happens when an employee does not provide a 
sufficient amount of urine for a drug test?

* * * * *
    (b) * * *
    (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. Document on the Remarks line of the CCF (Step 2), and inform the 
employee of, the time at which the three-hour period begins and ends.
    (3) If the employee refuses to make the attempt to provide a new 
urine specimen or leaves the collection site before the collection 
process is complete, 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.
* * * * *


Sec. 40.195  [Amended]

    27. Amend Sec. 40.195 by adding, in the section heading and in the 
introductory text of paragraph (a), after the word

[[Page 41954]]

``pre-employment'', the words ``, follow-up,''.

    28. Amend Sec. 40.203 by revising paragraphs (b) and (d)(3) to read 
as follows:


Sec. 40.203  What problems cause a drug test to be cancelled unless 
they are corrected?

* * * * *
    (b) The following is a ``correctable flaw'' that laboratories must 
attempt to correct: The collector's signature is omitted on the 
certification statement on the CCF.
* * * * *
    (d) * * *
    (3) The collector uses a non-Federal form or an expired Federal 
form for the test. This flaw may be corrected through the procedure set 
forth in Sec. 40.205(b)(2), provided that the collection testing 
process has been conducted in accordance with the procedures of this 
part in an HHS-certified laboratory. During the period August 1-October 
31, 2001, you are not required to cancel a test because of the use of 
an expired Federal form. Beginning November 1, 2001, if the problem is 
not corrected, you must cancel the test.

    29. Amend Sec. 40.205 by revising paragraph (b)(2) to read as 
follows:


Sec. 40.205  How are drug test problems corrected?

* * * * *
    (b) * * *
    (2) If the problem is the use of a non-Federal form or an expired 
Federal form, you must provide a signed statement (i.e., a memorandum 
for the record). It must state that the incorrect form contains all the 
information needed for a valid DOT drug test, and 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 or 
expired Federal forms for DOT tests. For this flaw to be corrected, the 
test of the specimen must have occurred at a HHS-certified laboratory 
where it was tested consistent with the requirements of 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.
* * * * *

    30. Add a new Sec. 40.208, to read as follows:


Sec. 40.208  What problem requires corrective action but does not 
result in the cancellation of a test?

    (a) If, as a laboratory, collector, employer, or other person 
implementing the DOT drug testing program, you become aware that the 
specimen temperature on the CCF was not checked and the ``Remarks'' 
line did not contain an entry regarding the temperature being out of 
range, you must take corrective action, including securing a memorandum 
for the record explaining the problem and taking appropriate action to 
ensure that the problem does not recur.
    (b) This error does not result in the cancellation of the test.
    (c) As an employer or service agent, this error, even though not 
sufficient to cancel a drug test result, may subject you to enforcement 
action under DOT agency regulations or Subpart R of this part.

    31. Amend Sec. 40.209 as follows:
    a. Revise the heading of the section.
    b. In paragraph (c), after the word ``employer'' add the words ``or 
service agent''.
    c. In paragraph (c), after the word ``regulations'' add the words 
``or action under Subpart R of this part''.
    The revision reads as follows:


Sec. 40.209  What procedural problems do not result in the cancellation 
of a test and do not require correction?

* * * * *

    32. Amend Sec. 40.213 as follows:
    a. Amend the introductory text of paragraph (c) by removing the 
words ``three consecutive error-free mock tests'' and adding in their 
place the words ``seven consecutive error-free mock tests (BATs) or 
five consecutive error-free tests (STTs)''.
    b. Amend paragraph (e) by adding a sentence at the end of the 
paragraph, to read as follows:


Sec. 40.213  What training requirements must STTs and BATs meet?

* * * * *
    (e) * * * If you are a BAT or STT who completed qualification 
training before January 1, 1998, you are not required to complete 
refresher training until January 1, 2003.
* * * * *

    33. Amend Sec. 40.225 as follows:
    a. In paragraph (a), after the word ``test'' add the words 
``beginning February 1, 2002''.
    b. Revise paragraph (b)(4) to read as follows:


Sec. 40.225  What form is used for an alcohol test?

* * * * *
    (b) * * *
    (4) You may use an ATF in which all pages are printed on white 
paper. You may modify the ATF by using colored paper, or have clearly 
discernable borders or designation statements on Copy 2 and Copy 3. 
When colors are used, they must be green for Copy 2 and blue for Copy 
3.
* * * * *

    34. Amend Sec. 40.229 by adding a new sentence after the first 
sentence to read as follows:


Sec. 40.229  What devices are used to conduct alcohol screening tests?

    * * * You may use an ASD that is on the NHTSA CPL for DOT alcohol 
tests only if there are instructions for its use in this part. * * *


Sec. 40.253  [Amended]

    35. Amend Sec. 40.253(c) by removing the word ``sequential'' and 
adding in its place the word ``unique''.

    36. Amend Sec. 40.261 as follows:
    a. Revise paragraphs (a)(1) through (a)(3).
    b. In paragraph (a)(6), remove the words ``Sec. 40.241(b)(7));'' 
and add, in their place, the words ``Secs. 40.241(g) and 40.251(d));''
    The revisions read as follows:


Sec. 40.261  What is a refusal to take an alcohol test, and what are 
the consequences?

    (a) * * *
    (1) Fail to appear for any test (except a pre-employment test) 
within a reasonable time, as determined by the employer, consistent 
with applicable DOT agency regulations, 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 a C/TPA (see 
Sec. 40.241(a));
    (2) Fail to remain at the testing site until the testing process is 
complete; Provided, That an employee who leaves the testing site before 
the testing process commences (see Sec. 40.243(a)) for a pre-employment 
test is not deemed to have refused to test;
    (3) Fail to provide an adequate amount of saliva or breath for any 
alcohol test required by this part or DOT agency regulations; Provided, 
That an employee who does not provide an adequate amount of breath or 
saliva because he or she has left the testing site before the testing 
process commences (see Sec. 40.243(a)) for a pre-employment test is not 
deemed to have refused to test;
* * * * *

    37. Amend Sec. 40.329 by revising paragraph (c) to read as follows:


Sec. 40.329  What information must laboratories, MROs, and other 
service agents release to employees?

* * * * *

[[Page 41955]]

    (c) As a SAP, you must make available to an employee, on request, a 
copy of all SAP reports (see Sec. 40.311). However, you must redact 
follow-up testing information from the report before providing it to 
the employee.

    38. Amend Sec. 40.331 by revising paragraphs (b)(2) and (c)(2), and 
adding new paragraphs (b)(3) and (c)(3), to read as follows:


Sec. 40.331  To what additional parties must employers and service 
agents release information?

* * * * *
    (b) * * *
    (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. You must provide this information 
at your principal place of business in the time required by the DOT 
agency.
    (3) All items in paragraph (b)(2) of this section must be easily 
accessible, legible, and provided in an organized manner. If electronic 
records do not meet these standards, they must be converted to printed 
documentation that meets these standards.
    (c) * * *
    (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. You must provide this information 
at your principal place of business in the time required by the DOT 
agency.
    (3) All items in paragraph (c)(2) of this section must be easily 
accessible, legible, and provided in an organized manner. If electronic 
records do not meet these standards, they must be converted to printed 
documentation that meets these standards.
* * * * *

    39. Amend Sec. 40.333 as follows:
    a. In paragraphs (a)(1)(i) and (a)(1)(ii), remove the word 
``employee''.
    b. In paragraph (d), remove the word ``working'' and add in its 
place the word ``business''.
    c. Add a new paragraph (e), to read as follows:


Sec. 40.333  What records must employers keep?

* * * * *
    (e) If you store records electronically, where permitted by this 
part, you must ensure that the records are easily accessible, legible, 
and formatted and stored in an organized manner. If electronic records 
do not meet these criteria, you must convert them to printed 
documentation in a rapid and readily auditable manner, at the request 
of DOT agency personnel.


Sec. 40.349  [Amended]

    40. Amend Sec. 40.349(e) by adding the word ``business'' after the 
word ``two''.

    41. Amend Sec. 40.355 as follows:
    a. Add a sentence at the end of paragraph (a).
    b. In paragraph (j)(1), remove the words ``You are authorized by a 
DOT agency regulation to do so, you'' and add the word ``You'' in their 
place.
    The addition reads as follows:


Sec. 40.355  What limitations apply to the activities of service 
agents?

* * * * *
    (a) * * * No one may do so on behalf of a service agent.
* * * * *


Sec. 40.403  [Amended]

    42. Amend Sec. 40.403(a) by removing the word ``working'' and 
adding in its place the word ``business''.

    43. Amend Appendix F to Part 40 by revising the list entitled 
``Drug Testing Information, to read as follows:

Appendix F to Part 40--Drug and Alcohol Testing Information That C/TPAs 
May Transmit to Employers

* * * * *

Drug Testing Information

Sec. 40.25: Previous two years' test results
Sec. 40.35: Notice to collectors of contact information for DER
Sec. 40.61(a): Notification to DER that an employee is a ``no show'' 
for a drug test
Sec. 40.63(e): Notification to DER of a collection under direct 
observation
Sec. 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
Sec. 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.)
Sec. 40.111(a): Transmission of laboratory statistical report to 
employer
Sec. 40.127(f): Report of test results to DER
Secs. 40.127(g), 40.129(d), 40.159(a)(4)(ii); 40.161(b): Reports to 
DER that test is cancelled
Sec. 40.129 (d): Report of test results to DER
Sec. 40.129(g)(1): Report to DER of confirmed positive test in 
stand-down situation
Secs. 40.149(b): Report to DER of changed test result
Sec. 40.155(a): Report to DER of dilute specimen
Sec. 40.167(b) and (c): Reports of test results to DER
Sec. 40.187(a)-(f) Reports to DER concerning the reconfirmation of 
tests
Sec. 40.191(d): Notice to DER concerning refusals to test
Sec. 40.193(b)(3): Notification to DER of refusal in shy bladder 
situation
Sec. 40.193(b)(4): Notification to DER of insufficient specimen
Sec. 40.193(b)(5): Transmission of CCF copies to DER (not to MRO)
Sec. 40.199: Report to DER of cancelled test and direction to DER 
for additional collection
Sec. 40.201: Report to DER of cancelled test

* * * * *
[FR Doc. 01-19232 Filed 8-2-01; 4:41 p.m.]
BILLING CODE 4910-62-U