49850 Federal Register / Vol. 75, No. 157 / Monday, August 16, 2010 / Rules and Regulations 

negotiated basis) to determine the nature and 

extent of required repairs. 

(2) Upon determination by the Contracting 

Officer of what work is necessary, the 

Contractor, if requested by the Contracting 

Officer, shall negotiate prices for 

performance of that work. The prices agreed 

upon shall be set forth in a modification of 

the job order. 

(3) Failure of the parties to agree upon the 

price shall constitute a dispute under the 

Disputes clause. In the meantime, the 

Contractor shall diligently proceed to 

perform the work ordered. 

(End of clause) 

[FR Doc. 2010–20168 Filed 8–13–10; 8:45 am] 

BILLING CODE 5001–08–P 

DEPARTMENT OF TRANSPORTATION 

Office of the Secretary 

49 CFR Part 40 

[Docket OST–2010–0026] 

RIN 2105–AD95 

Procedures for Transportation 

Workplace Drug and Alcohol Testing 

Programs 

AGENCY: Office of the Secretary, DOT. 

ACTION: Final rule. 

SUMMARY: The Department of 

Transportation (the Department or DOT) 

is amending certain provisions of its 

drug testing procedures dealing with 

laboratory testing of urine specimens. 

Some of the changes will also affect the 

training of and procedures used by 

Medical Review Officers. The changes 

are intended to create consistency with 

many, but not all, of the new 

requirements established by the U.S. 

Department of Health and Human 

Services. 

DATES: This rule is effective October 1, 

2010. 

FOR FURTHER INFORMATION CONTACT: 

Mark Snider, Senior Policy Advisor (S– 

1), Office of Drug and Alcohol Policy 

and Compliance, 1200 New Jersey 

Avenue, SE., Washington, DC 20590; 

telephone number 202–366–3784 

(voice), 202–366–3897 (fax), or 

mark.snider@dot.gov (e-mail). 

SUPPLEMENTARY INFORMATION: 

Background and Purpose 

On November 25, 2008 (73 FR 7185), 

the U.S. Department of Health and 

Human Services (HHS) Substance 

Abuse and Mental Health Services 

Administration (SAMHSA) issued a 

Final Notice of Revisions to the HHS 

Mandatory Guidelines for Federal 

Workplace Drug Testing Programs (HHS 

Mandatory Guidelines) that included 

changes to the procedures for collection 

and testing of urine specimens, creation 

of and requirements for the certification 

of Instrumented Initial Test Facilities 

(IITFs), collection site oversight 

requirements, and changes to the role of 

and standards for collectors and 

Medical Review Officers (MROs). The 

HHS Mandatory Guidelines were to 

become effective May 1, 2010, but on 

April 30, 2010 (75 FR 22809), HHS 

postponed implementation until 

October 1, 2010. 

On February 4, 2010, DOT published 

a Notice of Proposed Rulemaking 

(NPRM) (75 FR 5722) seeking comments 

about changing part 40 to be consistent 

with certain aspects of the HHS 

Mandatory Guidelines. The final rule 

responds to the comments and makes a 

number of changes to the existing rules 

governing the Department’s drug testing 

program. 

Principal Policy Issues 

Requirements of the Omnibus 

Transportation Employee Testing Act of 

1991 

Several commenters questioned 

whether and to what extent the 

Department must follow the HHS 

Mandatory Guidelines. Some 

commenters urged the Department to 

choose a different approach from the 

HHS regarding the drugs for which 

testing occurs, the initial testing of all 

specimens for 6–Acetylmorphine (6– 

AM), and the use of IITFs. Although 

since its passage, the Department has 

cited the Omnibus Transportation 

Employee Testing Act of 1991, 49 U.S.C. 

31300, et seq., 49 U.S.C. 20100, et seq., 

49 U.S.C. 5330, et seq., and 49 U.S.C. 

45100, et seq. (Omnibus Act), as the 

definitive authority for our reliance on 

the HHS Mandatory Guidelines for 

scientific testing issues, several of the 

commenters have challenged this or 

otherwise asked the Department to 

clarify what the Omnibus Act requires. 

Even before the Omnibus Act, the 

Department looked to the HHS 

Mandatory Guidelines for guidance on 

scientific matters. In a 1988 Interim 

Final Rule (IFR) the Department relied 

upon the HHS for testing methodologies 

to determine the drugs for which testing 

would be done and which laboratories 

to use. Specifically, the Department 

noted that under ‘‘the HHS Guidelines, 

a Federal agency may test a urine 

sample only for certain specified drugs. 

The Department’s Procedures echo this 

requirement.’’ (53 FR 47002, Nov. 21, 

1988; emphasis in the original) In the 

same IFR, the Department required 

regulated transportation employers to 

use only laboratories certified under the 

HHS Mandatory Guidelines for Federal 

Workplace Drug Testing Programs. 

While deciding to utilize many aspects 

of the HHS Mandatory Guidelines, the 

Department acknowledged ‘‘that the 

Guidelines, as written by HHS to apply 

to testing by Federal agencies, do not fit 

perfectly the circumstances of 

employers regulated by DOT * * *. 

Obviously, the circumstances of 

industries regulated by DOT are very 

different from those of Federal 

agencies.’’ (53 FR 47002) Thus, the 

Department began to lay the foundation 

for using the technical expertise of the 

HHS for the scientific aspects of DOT’s 

testing program while relying upon the 

Department’s own authority and that of 

DOT agencies to tailor many procedural 

aspects of DOT testing to fit the 

transportation industries. 

In a 1989 final rule, we discussed the 

applicability of the Fourth Amendment 

of the United States Constitution to both 

the Federal agency programs covered by 

the HHS Mandatory Guidelines and the 

testing that transportation employers 

would conduct in response to the 

Department’s requirements. The 

Department acknowledged that the HHS 

Mandatory Guidelines had passed 

Constitutional scrutiny by the Federal 

courts, all the way up to the Supreme 

Court of the United States. The Federal 

courts concluded that HHS had met the 

Fourth Amendment balancing of the 

Federal need to ensure safety by drug 

testing versus individuals’ strong 

interests in their right to privacy. The 

HHS Mandatory Guidelines had set up 

a testing system with sound 

methodology that ensured privacy and 

accuracy. Given these considerations, 

the Department decided to rely on HHS 

for the science of DOT’s testing program 

and for the drugs for which we test, the 

testing methodologies, and the integrity 

of the HHS certified laboratories. (54 FR 

49854, Dec. 1, 1989) 

Congress endorsed the Department’s 

decision by explicitly directing, in the 

Omnibus Act, the Department to 

incorporate the HHS scientific and 

technical guidelines for laboratories and 

testing procedures for controlled 

substances. The Omnibus Act 

specifically requires that we incorporate 

the HHS scientific and technical 

guidelines that ‘‘establish 

comprehensive standards for all aspects 

of laboratory controlled substances 

testing’’ in order to ensure full reliability 

and accuracy in testing. [49 U.S.C. 

31306(c)(2)(A), 49 U.S.C. 20140(c)(2)(A), 

49 U.S.C. 5331(d)(2)(A) and 49 U.S.C. 

45104(2)(A)] The legislative history for 

the Omnibus Act indicates the following 

intent: ‘‘Incorporating the HHS 

WReier-Aviles on DSKGBLS3C1PROD with RULES

Federal Register / Vol. 75, No. 157 / Monday, August 16, 2010 / Rules and Regulations 49851 

guidelines relating to laboratory 

standards and procedures for testing 

controlled substances, as proposed by 

the reported bill and as DOT has done 

in part 40 of title 49 CFR, as it exists at 

this writing, is an essential component 

of the procedural safeguard.’’ Senate 

Report 102–54, Omnibus Transportation 

Employee Testing Act of 1991, Report of 

the Senate Committee on Commerce, 

Science and Transportation on S.676, 

102nd Congress, 1st Session, May 2, 

1991, page 26 (Senate Report 102–54) 

(emphasis added). The Omnibus Act 

also requires the Department and DOT 

agencies to look to the HHS for 

laboratory certification, the procedures 

for reviewing laboratories for 

certification, and the procedures for the 

revocation of such certification. In 

addition, the Department must follow 

the HHS Mandatory Guidelines 

regarding establishing the list of drugs 

for which we test and the procedures for 

use of the Federal Drug Testing Custody 

and Control Form (CCF) to establish the 

chain of custody of specimens. 

The legislative history of the Omnibus 

Act indicates that Congress wanted the 

Department and DOT agencies to 

continue use of the HHS scientific and 

technical guidelines and the HHS 

certified laboratories to ensure accuracy, 

fairness, and the constitutionality of 

DOT’s drug testing program. While the 

Omnibus Act was being drafted, 

opponents of drug testing warned that 

employees were in danger of ‘‘false 

positives’’ that would result from initial 

screening of urine that might indicate 

levels of illegal drugs. The Senate noted 

that it had addressed this concern: ‘‘By 

incorporating laboratory certification 

and testing procedures developed by 

HHS and DOT and by providing for the 

subdivision of specimens and the 

opportunity for an independent test of 

positive samples, the Committee has 

taken affirmative steps to ensure 

accuracy.’’ Senate Report 102–54, pages 

6–7. The legislative history for the 

Omnibus Act makes numerous 

additional references to the 

understanding that the Department 

would work with HHS to ensure testing 

accuracy. 

There is also clear indication in the 

legislative history that Congress 

recognized that the HHS standards were 

likely to be modified over time. The 

Omnibus Act itself explicitly refers to 

incorporating the HHS ‘‘scientific and 

technical guidelines dated April 11, 

1988, and any subsequent amendments 

thereto * * *’’ 49 U.S.C. 31306(c)(2), 49 

U.S.C. 20140(c)(2), 49 U.S.C. 5331(d)(2) 

and 49 U.S.C. 45104(2). Allowing for 

subsequent amendments, however, did 

not mean that Congress wanted to lower 

the standards for testing. ‘‘Realizing that 

these guidelines possibly are subject to 

future modification, the Committee has 

acted to specify that the basic elements 

of certain provisions now in effect are 

mandated, including the need for 

comprehensive standards and 

procedures for all aspects of laboratory 

testing of drugs, the establishment of a 

minimum list of controlled substances 

for which employees may be tested, the 

establishment of standards and 

procedures for the periodic review of 

laboratories, and the development of 

criteria for laboratory certification.’’ 

Senate Report 102–54, pages 21–22, 26 

and 32. 

When the Omnibus Act requires the 

Department to follow HHS on specified 

scientific matters, we adhere to the 

requirements. When the Omnibus Act 

allows the Department the option of 

following HHS, we have always and 

will continue to weigh the costs and 

benefits of following HHS in light of our 

mission. However, when the Omnibus 

Act specifically requires the Department 

to take a direction different from that 

which HHS takes, then the Department 

is prohibited from following HHS on 

such matters. 

In reviewing the Omnibus Act, its 

legislative history, and the regulatory 

history of the Department’s testing 

program, it remains clear that, since the 

inception of our program, the 

Department has been tied to HHS for the 

scientific methodology, for 

identification of the drugs for which we 

will require testing; the certified 

laboratories we are to use; and the 

technical expertise for certifying and 

decertifying laboratories. These are the 

core scientific laboratory functions 

necessary for the Department’s program. 

However, it is important to note that 

the Department has discretion 

concerning many other aspects of the 

regulations governing testing in the 

transportation industries’ regulated 

programs. 

As far back as 1988, our regulations 

established the fundamental roles and 

concepts for the current DOT regulated 

industry testing program. Our early 

regulations established how collections 

were to be done, who could be an MRO 

or a Substance Abuse Professional 

(SAP), and the respective training for 

and responsibilities of these important 

gatekeepers. While relying on HHS for 

certain scientific efforts, we did not 

necessarily follow HHS regarding 

collection issues, laboratory reporting 

requirements, how MROs handle certain 

test results, the rehabilitation and the 

return-to-duty process, and other areas 

covered by the HHS Mandatory 

Guidelines. The Department’s regulation 

and the regulations of DOT agencies set 

their own processes and procedures for 

all aspects leading up to and through 

specimen collection and then picking 

up from what processes and procedures 

would occur after a laboratory 

confirmed a drug test result, including 

the return-to-duty process for 

individuals who have non-negative test 

results. In shaping our program to fit the 

needs of the transportation industries, 

the Department and DOT agencies have 

made adaptations to meet the changing 

needs of the transportation industries. 

In some cases we have consequently 

chosen a different path from the one 

chosen by HHS on the same or similar 

non-scientific issues. 

The Omnibus Act acknowledged that 

such Departmental and DOT agency 

regulations were in place with respect to 

non-scientific issues. Congress 

explicitly allowed these regulations to 

continue in effect, with the option for 

the Department and DOT agencies to 

amend or further supplement their 

respective regulations in the future. 49 

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

49 U.S.C. 45106(c). 

One example of the Department’s 

divergence from HHS on non-scientific 

matters covered in the HHS Mandatory 

Guidelines is the issue of how to 

conduct direct observation collections. 

On June 25, 2008, the Department 

issued a final rule (73 FR 35961) that, 

among other amendments, modified 49 

CFR part 40 at section 40.67(b) and 

added a new paragraph 40.67(i) to 

improve direct observation procedures 

to better address known adulteration 

and substitution threats. Although HHS 

addresses direct observation collections 

in the HHS Mandatory Guidelines, the 

Department chose to use a different 

procedure because of evidence 

regarding cheating and our experience 

in regulating the transportation 

industries. In explaining our rationale, 

we noted that the use of direct 

observation collections is ‘‘a very 

significant tool the Department employs 

to combat attempts by employees to 

cheat on their tests.’’ (74 FR 37949, July 

30, 2009) In addition, we stated in the 

final rule reinstating the direct 

observation provisions after the court 

victory, ‘‘the Department remains 

convinced that conducting all return-toduty and follow-up tests under direct 

observation is the most prudent course 

from the viewpoint of safety.’’ (74 FR 

37950, quoting the October 22, 2008 

final rule preamble at 73 FR 62918) 

The Department’s regulations 

concerning direct observation 

procedures were affirmed by a 

unanimous court. (BNSF Railway 

Company v. Department of 

WReier-Aviles on DSKGBLS3C1PROD with RULES

49852 Federal Register / Vol. 75, No. 157 / Monday, August 16, 2010 / Rules and Regulations 

Transportation, 566 F.3d 200 (DC Cir. 

2009) In upholding the rule, the U.S. 

Court of Appeals for the D.C. Circuit 

noted that the Department had 

experience, comments, and evidence to 

support the need to make the 

improvements to the direct observation 

procedures. BNSF Railway Company v. 

Department of Transportation, 566 F.3d 

at 204. The Court further found that the 

improved procedures were 

constitutional, stating, ‘‘[g]iven the 

combination of the vital importance of 

transportation safety, the employees’ 

participation in a pervasively regulated 

industry, their prior violations of the 

drug regulations, and the ease of 

obtaining cheating devices capable of 

defeating standard testing procedures, 

we find the challenged regulations 

facially valid under the Fourth 

Amendment.’’ Id. at 208. Hence, the 

Department chose a different approach 

from HHS on direct observation 

procedures, tailored them to the needs 

identified, and the Court upheld this 

approach as constitutional. 

Some of the commenters asked the 

Department to consider deviating from 

the HHS Mandatory Guidelines 

regarding the drugs for which testing is 

required. Some commenters want the 

Department to exclude 

Methylenedioxymethamphetamine 

(MDMA) from the list of drugs, while 

others want the Department to include 

synthetic opiates, and others want 

alternative testing methodologies to be 

employed. 

It is not unusual for the Department 

to receive requests from commenters to 

move away from the illegal drugs for 

which HHS has set the protocols; 

however, the Department has remained 

consistent in our responses and our 

reliance upon HHS as the scientific 

experts in these matters. What the 

Department stated in response to similar 

requests in the late 1990s to move 

beyond the HHS minimums still 

remains true: ‘‘This is a long-standing 

issue in the program, and DOT 

continues to take the position that we 

ought not to go beyond the testing that 

HHS has authorized and for which HHS 

has certified laboratories.’’ (65 FR 79484, 

Dec. 19, 2000) In response to those who 

have urged DOT to go beyond the drugs 

for which HHS tests, we have 

consistently stated: ‘‘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.’’ 

(65 FR 79491, Dec. 19, 2000) Although 

the HHS has now expanded its panel to 

include an additional amphetamine, 

MDMA, the same reasoning holds true 

and the Department will continue to 

follow the HHS testing protocols for the 

reasons we explained in 2000. 

Also in 2000, the Department 

explained, ‘‘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.’’ (65 FR 79489, Dec. 

19, 2000) Furthermore, in the preamble 

to our Specimen Validity Testing final 

rule in 2008 (SVT Final Rule), we stated 

that the Omnibus Act ‘‘provides only 

one way to determine that an employee 

has tested positive for illicit drug use— 

a drug test confirmed by an HHScertified laboratory using HHS scientific 

and testing protocols and verified by an 

MRO.’’ (73 FR 35966, June 25, 2008) 

The Department, as required by the 

Omnibus Act, has consistently 

specifically followed HHS on laboratory 

certification matters, but we have also 

created responsibilities for laboratories 

under part 40 that do not impinge upon 

the scientific and technical aspects of 

drug testing. As the Department stated 

in 2000, ‘‘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.’’ (65 FR 79484, Dec. 19, 

2000) 

At times, we have had to adapt certain 

aspects of technical drug testing matters 

to fit the needs of the transportation 

industries. For example, in 2003, the 

Department issued an interim final rule 

(2003 IFR) concerning laboratory 

substitution criteria. (68 FR 31624, May 

28, 2003) In the 2003 IFR, we did not, 

and could not, change the HHSestablished laboratory testing 

substitution criteria, but instead 

addressed how laboratories were to 

report out their findings to the MROs on 

the CCF, what subsequent actions 

would be required of the MROs with 

respect to the reported result, and 

whether to tell the employer to send the 

employee back in for a direct 

observation collection. In short, we said 

that specimens reported by laboratories 

as substituted with creatinine 

concentration in the 2–5 ng/mL range 

would not be considered by MROs to be 

refusals to test. Instead, transportation 

employees with such results would 

require immediate recollections under 

direct observation. 

In a July 2008 interpretation, which is 

being incorporated in this final rule at 

section 40.159, the Department 

instructed MROs on how to ‘‘handle 

laboratory results reported as invalid 

because of pH greater than or equal to 

9.0 but less than or equal to 9.5.’’ This 

is another example of how the 

Department has adapted the HHS 

scientific requirements established for 

laboratories to the needs of the 

transportation industries. In fact, the 

HHS Mandatory Guidelines have 

adopted our MRO provisions for 

invalids due to pH in the 9.0–9.5 range. 

We read the Omnibus Act to require 

the Department to follow the HHS on 

the drugs for which we test and the 

testing protocols, but the Omnibus Act 

allows us to, and we have chosen to, 

diverge from the HHS and the HHS 

Mandatory Guidelines on collections, 

MROs, and what laboratories can report. 

As we said in our 2008 SVT Final Rule 

preamble, ‘‘Since Congress specifically 

limited the scientific testing 

methodology upon which DOT can rely 

in making its drug and alcohol testing 

regulations; we follow the HHS 

scientific and technical guidelines, 

including the amendments to their 

Mandatory Guidelines.’’ (73 FR 35961, 

June 25, 2008) In the 2008 SVT Final 

Rule, we also explained that the 

‘‘Omnibus Act requires the DOT to 

incorporate the HHS scientific and 

technical guidelines, and we do not 

have the authority to impose additional 

scientific and technical requirements 

upon the laboratories.’’ (73 FR 35963, 

June 25, 2008) 

In response to the commenters who 

would like us to consider alternative 

specimens such as hair testing and point 

of collection testing, we reiterate what 

we said in response to comments on our 

direct observation final rule in late 

2008: ‘‘The Department is not opposed 

to the use of alternative, less intrusive, 

testing methods as a means of 

accomplishing the safety purposes of 

the program while preventing 

individuals from cheating. Under the 

Omnibus Transportation Employee 

Testing Act of 1991, however, the 

Department is authorized to use only 

testing methods that have been 

approved by the Department of Health 

and Human Services (HHS). To date, 

HHS has not approved any specimen 

testing except urine.’’ (73 FR 62917, Oct. 

22, 2008) Therefore, we cannot consider 

alternative specimens at this particular 

point in time. In fact, DOT would not 

desire to do so without the HHS 

WReier-Aviles on DSKGBLS3C1PROD with RULES

Federal Register / Vol. 75, No. 157 / Monday, August 16, 2010 / Rules and Regulations 49853 

scientific and laboratory certification 

processes being in place. 

Several commenters have asked us to 

explain how the Omnibus Act affects 

the Department’s determination of 

whether it will and will not follow HHS. 

In response, as we explained above, 

where the Omnibus Act requires the 

Department to follow the HHS—for the 

laboratory and testing procedures, the 

Department will follow the scientific 

and technical aspects prescribed by the 

HHS. Where the Omnibus Act limits or 

otherwise prohibits the Department 

from following the HHS, the Department 

must decline to follow the lead of the 

HHS. For example, when HHS did not 

embrace a split specimen requirement, 

the Department departed from the HHS 

Mandatory Guidelines due to the 

Omnibus Act’s requirements for split 

specimens. Where the HHS takes a 

position that we are neither required to 

follow nor prohibited from following, 

the Department will continue to view 

the HHS position as optional. We 

recognize that the HHS has expertise in 

the Federal employee testing program 

for these optional matters, but the 

Department has its own expertise as the 

regulator of the largest workplace drug 

and alcohol testing program in the 

world. As such, we will consider the 

optional matters in light of 

transportation safety, the costs and 

benefits to our regulated industries, and 

scientific and forensic considerations. 

Use of Instrumented Initial Test 

Facilities 

In our NPRM, we proposed allowing 

DOT employers to choose between full 

service laboratories and IITFs. An IITF 

would be able to provide results to 

employers only for negative and certain 

negative dilute specimens, as well as 

specimens they reject for testing. All 

other specimens would be forwarded to 

an HHS certified, full service laboratory. 

We requested comments as to how this 

process would impact the industry, 

specifically employers. The majority of 

commenters felt that use of IITFs would 

be detrimental to the turnaround time 

for reporting of non-negative results and 

most did not favor use of IITFs. Other 

commenters believed IITFs would be 

very useful, accurate, and afford the 

ability for a rapid turnaround time for 

their negative results. 

DOT Response 

The Omnibus Act actually prohibits 

the Department from following HHS on 

the issue of IITFs. The Omnibus Act 

requires ‘‘that all laboratories involved 

in the controlled substances testing of 

any individual under this section shall 

have the capability and facility, at such 

laboratory, of performing screening and 

confirmation tests.’’ (49 U.S.C. 

31306(c)(3), 49 U.S.C. 20140(c)(3), 49 

U.S.C. 5331(d)(3) and 49 U.S.C. 

45104(3)) An IITF can conduct the 

initial screening for drugs in a urine 

specimen, but is not certified to provide 

a confirmation test. 

Since IITFs do not have any 

confirmation testing capabilities, the 

Department must not use them in part 

40. The Senate Report for S. 676, the bill 

that subsequently became the Omnibus 

Act, indicates the intent behind this 

requirement was to ensure that ‘‘[a]ny 

testing program would be required to 

include procedures to protect individual 

privacy, incorporate laboratory 

certification and testing procedures 

developed by [HHS] * * * require that 

all laboratories involved in testing for 

drugs have the capability of performing 

screening and confirmation tests at such 

laboratory.’’ Senate Report 102–54, 

pages 10–11. Because IITFs do not offer 

confirmation testing, the Department is 

prohibited by the Omnibus Act from 

using laboratory facilities that lack the 

capability to perform both screening and 

confirmation tests. Therefore, DOT 

employers do not have the option of 

using IITFs. For this reason there are no 

provisions in this final rule for IITFs, 

and they will not be authorized for use 

in DOT’s program by our regulated 

employers. 

MDMA Testing 

In the NPRM, we proposed to 

incorporate testing for MDMA into part 

40. 

Comments 

A majority of commenters favored 

testing for MDMA. A few commenters 

indicated that their data showed that 

there would be relatively few positive 

test results, creating an unnecessary cost 

burden to employers. One laboratory 

group opposed the inclusion of MDMA 

and suggested the Department test 

instead for ‘‘hydromorphone, 

hydrocodone, oxycodone, and 

oxymorphone.’’ 

Those who favored testing MDMA 

represented a wide range of interests— 

MRO groups, third-party administrators, 

a major employer association, a major 

service agent association, among them. 

Most who supported testing for MDMA 

said that many employers were already 

testing for MDMA in their non-DOT 

testing programs. They supported 

putting MDMA testing into the Federal 

testing arena. 

Some commenters presented 

information about the use of MDMA, 

saying that MDMA was no longer a 

threat; MDMA is strictly a drug for 

younger persons; MDMA is a ‘‘club’’ 

drug that is not being used by 

transportation employees. 

Others presented data showing that 

MDMA use is on the rise and the 

implication is that the threat of MDMA 

use will become greater as the current 

transportation population is replaced 

via attrition by a younger population. 

DOT Response 

In this rulemaking, we are adopting 

the HHS laboratory testing requirements 

of conducting initial testing for MDMA, 

conducting confirmatory testing for 

MDMA, Methylenedioxyamphetamine 

(MDA), and 

Methylenedioxyethylamphetamine 

(MDEA). As we stated in our NPRM, 

regarding such matters, ‘‘past experience 

has shown that DOT has never deviated 

from HHS on laboratory testing 

matters—the drugs for which we test, 

the specimens we test, specimen 

validity testing values, initial and 

confirmatory cutoff values, and 

laboratory testing processes and 

procedures, among others. The DOT is 

required by the Omnibus Transportation 

Employee Testing Act of 1991 to adhere 

with the HHS on these important 

laboratory testing matters.’’ (75 FR 5722– 

5723, Feb. 4, 2010) We can provide 

additional guidance to MROs, as 

appropriate, so that these changes fit the 

transportation industries. However, we 

do not read our authority as allowing us 

to depart from HHS on this subject. 

Aside from the fact that the Omnibus 

Act requires us to test the drugs for 

which HHS labs are certified to test, we 

note that, as some commenters said, 

MDMA is not just a ‘‘club drug’’ any 

more, it is being marketed to a much 

larger population in American 

communities. 

The Department of Justice National 

Drug Intelligence Center’s 2010 National 

Drug Threat Assessment (http:// 

www.justice.gov/ndic/pubs38/38661/ 

38661p.pdf ) supports DOT’s conclusion 

with regard to MDMA availability, 

finding: 

‘‘Asian DTOs [Drug Trafficking 

Organizations] are responsible for a 

resurgence in MDMA availability in the 

United States, particularly since 2005. These 

groups produce large quantities of the drug 

in Canada and smuggle it into the United 

States across the Northern Border. The 

smuggling of MDMA into the United States 

from Canada fueled an increase in the 

availability of the drug that began in 2005, 

although availability appears to be 

stabilizing. Data regarding MDMA 

availability are limited; nonetheless, analysis 

of National Forensic Laboratory Information 

System (NFLIS) data shows a 76 percent 

increase in the number of MDMA 

submissions from 2005 to 2008, although 

WReier-Aviles on DSKGBLS3C1PROD with RULES

49854 Federal Register / Vol. 75, No. 157 / Monday, August 16, 2010 / Rules and Regulations 

MDMA submissions make up a much smaller 

percentage of submissions than other illicit 

drugs, including cannabis, cocaine, 

methamphetamine, and heroin. National 

Drug Threat Survey (NDTS) data also provide 

an indication of MDMA availability. The 

percentage of state and local law enforcement 

agencies that reported moderate or high 

availability of MDMA in their areas increased 

from 47.2 percent in 2005 to 51.5 percent in 

2009. 

Seizure data show that the amount of 

MDMA seized along the U.S.-Canada border 

increased 156 percent from 2007 to 2008 and 

that more MDMA was seized at the Northern 

Border in 2008 than in any year since 2005. 

MDMA seizure totals declined in 2009 but 

still exceeded 2007 totals. Although most 

Northern Border seizures occur at POEs 

(Points of Entry), the amount of MDMA 

seized between POEs appears to be 

increasing, likely because increased scrutiny 

at POEs has forced smugglers to develop new 

routes and smuggling methods in an attempt 

to circumvent law enforcement. 

For example, in 2008, more than 243,000 

dosage units of MDMA were seized between 

POEs, compared with none the previous year; 

seizures between POEs in 2009 exceeded 

those in 2008. 

MDMA seizures along the Southwest 

Border and through commercial air have also 

increased, albeit on a much smaller scale. 

Seizures at or near the Southwest Border 

show an increase from 114,286 dosage units 

in 2006 to 387,143 dosage units in 2009. 

Furthermore, commercial air seizures spiked 

in 2008, with a 91.4 percent increase from 

2007 to 2008 (433,571 dosage units to 

829,857 dosage units); MDMA commercial 

air seizure totals for 2009 decreased, 

resulting in levels comparable to 2007 levels. 

Ready availability of MDMA has enabled 

distributors to expand their customer base to 

include new user groups, most notably 

African American and Hispanic users. Asian 

DTOs have begun distributing MDMA to 

African American and Hispanic street gangs, 

which distribute the drug along with other 

illicit drugs in markets throughout the United 

States, most notably in the Southeast, 

Southwest, and Great Lakes Regions. 

Moreover, MDMA is no longer exclusively 

viewed as a ‘‘rave’’ or club drug, which also 

aids distributors in selling it to 

nontraditional abusers.’’ 

One laboratory group urged DOT to 

require testing prescription medications 

and synthetic drugs, rather than MDMA. 

While DOT shares the group’s concern 

about unauthorized use of the 

prescription medications and the use of 

synthetic drugs, testing for prescription 

medications and synthetic drug and 

testing for MDMA are separate issues. 

As part of their non-DOT testing 

programs, regulated employers can test 

for prescription medications or 

synthetic drugs and in many instances 

it may be appropriate to do so. 

Some DOT agencies and the United 

States Coast Guard (USCG), for instance, 

have medical qualification standards— 

for Commercial Drivers License holders, 

certified pilots and aviation mechanics, 

and licensed mariners—that focus upon 

the underlying medical conditions that 

would require use of prescription 

medications. Evaluating medical 

professionals are trained to seek 

information that would shed light on an 

individual’s use of medicines and their 

qualification to perform safety sensitive 

duties. 

It is also important to note that 

employers can expand upon the 

Department’s regulatory requirements, 

as long as they do not represent the test 

as being required by DOT. Under their 

non-DOT testing programs, DOTregulated companies may test for other 

drugs of their choosing. Therefore, 

companies are not prohibited by DOT 

from testing for additional drugs that 

may be of concern within their 

communities and companies. 

Lowering Laboratory Cutoff Criteria for 

Cocaine and Amphetamines 

The Department proposed, in the 

NRPM, to adopt the HHS-lowered 

laboratory testing cutoffs for cocaine 

and amphetamines. Initial test cutoffs 

for cocaine metabolites would go from 

300 to 150 ng/mL, while confirmation 

test cutoffs would go from 150 to 100 

ng/mL. 

For amphetamines, initial test cutoffs 

would go from 1000 to 500 ng/mL, 

while confirmation tests for 

amphetamines and methamphetamines 

would go from 500 to 250 ng/mL. 

Comments 

Most commenters support the 

Department’s conforming to the HHS 

Mandatory Guidelines in lowering the 

cutoffs for both cocaine and 

amphetamines. Most believe doing so 

will enhance the safety of the traveling 

public because more users of illicit 

drugs and more users of non-prescribed 

medications will be identified. There 

was no controversy about the new 

screening and confirmation test levels 

for cocaine. 

Some commenters believed that there 

could be ‘‘false positive’’ drug tests 

stemming from the new cutoffs for 

amphetamines. Some others believed 

the amphetamine cutoffs could even 

cause laboratories to report over-thecounter (OTC) medications as confirmed 

positive test results. Some others 

believed that lowering the screening 

cutoffs for amphetamines will provide 

little value in the confirmation process, 

serving only to increase the cost of the 

program. 

Some commenters cited the data from 

one of the laboratories—Clinical 

Research Laboratory (CRL)—as reason to 

support the new cutoffs, while others 

cited the same data as reason to oppose 

the new cutoffs. 

DOT Response 

As stated earlier in this document, the 

Department must follow the laboratory 

testing protocols and standards that are 

established by HHS. Therefore, we must 

and will adhere to the screening and 

confirmation drug testing cutoffs that 

HHS has established for the laboratories 

and for which the laboratories are 

certified. In addition, taken with the 

comment data from Quest Laboratories, 

we believe the laboratory data sets from 

both Quest and CRL lead likely to some, 

but not all, of the same conclusions. 

Regarding cocaine, based upon data 

provided by both Quest and CRL, we 

can expect a marked increase in cocaine 

users identified using the new screening 

and confirmation cutoffs that HHS has 

established. The Department, like the 

overwhelming number of commenters, 

considers this to be a beneficial change. 

In 2009, there were nearly 13,000 

positive DOT drug test results reported 

by laboratories as having confirmed 

positives for cocaine. Quest and CRL 

data show that we can expect a 

significant number of confirmed 

positive test results for cocaine using 

the new cutoffs. These new lower 

cutoffs should result in the Department 

identifying more cocaine users, further 

assuring the traveling public that the 

transportation system is the safest it can 

be. Doing so will also permit us to 

continue to further deter drug use in the 

transportation industries and get those 

identified as using drugs referred for 

evaluation and treatment. 

Regarding amphetamine and 

methamphetamine, the Quest data 

report on 68,000 regulated and 132,000 

non-regulated specimens and indicate 

that a 40% increase in screening and a 

30% increase in confirmation rates are 

expected; hence, a large number of 

currently non-detected users would be 

identified. 

A second submission of amphetamine 

and methamphetamine test data, this 

from CRL, includes the reanalysis of a 

much smaller number of regulated 

specimens. Several important facts 

about the CRL study protocols and 

results were not fully explained or 

clarified in their data submission. As a 

result, we are concerned that other 

commenters may have misinterpreted 

the CRL data as meaning that there will 

be ‘‘false positive’’ tests results for 

amphetamines and that some OTC 

medications—ephedrine, 

pseudoephedrine, and 

phenylpropanolamine—will be 

confirmed and reported as positives by 

laboratories. 

WReier-Aviles on DSKGBLS3C1PROD with RULES

Federal Register / Vol. 75, No. 157 / Monday, August 16, 2010 / Rules and Regulations 49855 

We want to address these 

commenters’ statements that testing at 

the new amphetamine screening cutoffs 

will yield ‘‘false positive’’ test results. 

Neither CRL nor Quest even alluded to 

there being a ‘‘false positive’’ testing 

issue with the new amphetamine 

cutoffs. Concerns about the risks of 

‘‘false positive’’ test results are not 

supported by the available data. In fact, 

no reportable positive test results were 

identified in the CRL and Quest data on 

specimens that did not, in fact, screen 

and confirm positive for a drug for 

which DOT tests. 

In addition, we want to clarify that no 

OTC medication that CRL chose to test 

for—ephedrine, pseudoephedrine, and 

phenylpropanolamine—would confirm 

positive on a DOT test and would be 

reported on a DOT test. We are 

concerned that the CRL confirmation 

testing on these specimens may have 

proven misleading to the groups who 

read the data and believed that our tests 

for amphetamines would identify these 

particular OTC medications. It is our 

opinion that CRL’s inclusion of this 

confirmation test data does not support 

CRL’s conclusion. Laboratories simply 

will not conduct confirmation testing 

for or identify these OTC medications in 

DOT’s program. 

It is also important to note that only 

confirmed positive drug tests are 

reported to the MRO as positive. No 

results screened positive are reported as 

positive until and unless they are also 

positive on a laboratory confirmation 

test and for the drugs for which we test. 

And, no test result is reported to the 

employer until the MRO properly 

verifies the result by determining if the 

employee has a legitimate medical 

explanation for the positive. If the 

employee has a legitimate medical 

explanation, the MRO will report the 

result to the employer as a negative test. 

These are ‘‘due process’’ steps that have 

always been an integral part of DOT’s 

testing program. 

We realize that laboratories will 

certainly screen specimens for 

amphetamines at the new HHS cutoffs 

and will not realize the same return rate 

on confirmed positive testing as they 

observe now, as CRL points out 

effectively in their data. CRL is 

concerned that the cost of confirming 

the increased number of screened 

positive tests does not warrant the 

expense for such a small number of 

confirmed positives, as shown by their 

data. 

It is important to note that the 

confirmation rates for opiates and 

amphetamines is now generally less 

than that for THC, cocaine, and PCP. 

Therefore, it is not unusual to see a 

disparity between screening rates and 

subsequent confirmation rates, 

especially for opiates and 

amphetamines. 

However, we will urge HHS to closely 

monitor this screening issue for 

amphetamines during the first year the 

new cutoffs are in place. We believe that 

the issue will be properly evaluated by 

HHS with DOT, the Center for 

Substance Abuse Prevention Drug 

Testing Advisory Board (CSAP DTAB), 

and laboratories in determining if the 

screening cutoffs for amphetamine 

would need to be modified upward if 

the added cost largely outweighed the 

benefits. The CSAP DTAB provides 

advice to the Administrator, SAMHSA, 

regarding the drug testing laboratory 

certification program. 

Laboratory Testing for 6– 

Acetylmorphine (6–AM) 

In the NPRM, we proposed to 

incorporate new HHS criteria for initial 

testing for 6–AM, a marker for heroin. 

We also asked if there were factual, 

evidence-based concerns about the need 

to show morphine with a 6–AM 

confirmed positive result. Also, if there 

were evidence-based systematic 

research and studies showing that 

morphine must also be present and 

quantitations reported, we asked for 

solutions by laboratories and/or MROs 

to adequately address the issue. 

Comments 

A slight majority of commenters 

expressed support for the new HHS 

screening and confirmation cutoffs for 

6–AM. Some who support the tests for 

6–AM do so because they believe 

transportation safety will be enhanced 

when more heroin users are identified 

and removed from their safety-sensitive 

duties. Several who do not support the 

provision express concern about the 

new cutoffs no longer requiring a test for 

morphine—something they say is 

imperative to ensure that the person is 

actually a heroin user. At least one 

commenter believes no additional 

heroin users will be identified and 

expresses concern about the cost of 

having only one supplier of laboratory 

reagent for 6–AM. 

Several laboratory entities and experts 

weighed in on the issue. RTI 

International (RTI) agreed with HHS for 

screening all specimens for 6–AM and 

for dropping the requirement to ensure 

a presence of morphine above 2000 ng/ 

mL. RTI indicated that the new testing 

will increase the positive rate by 8— 

29%, but failed to explain the basis for 

its concern. They also quote three 

studies as supporting the HHS decision. 

Clinical Research Laboratory (CRL) 

quoted their own study—for which we 

have no way to assess the adequacy of 

the study protocols—and stated that out 

of 820 tests for opiates and 6–AM, all 

screened at 3 ng/mL, versus the HHS 

cutoff of 10 ng/mL, and all except one 

had opiate positive results above the 

2,000ng/mL cutoff. CRL did not attempt 

to explain why this sample tested 

positive for 6–AM but did not test for 

morphine. They concluded that there is 

no published explanation for the 

detection of 6–AM without the presence 

of morphine. Therefore, CRL 

recommended that the Department 

provide guidance to MROs and 

laboratories about conferring with one 

another if there were ever 6–AM 

without the presence of morphine. 

Quest Laboratories reviewed 1.2 

million test results. Of those specimen 

results, 112 tested positive for 6–AM 

(heroin). The Quest study data indicated 

that 7 of those 112 6–AM positives also 

tested positive for morphine in the 300– 

2000 ng/mL range. The remaining 105 

6–AM positives had morphine 

confirmed above 2000 ng/mL. Quest 

suggested that ‘‘only’’ six tests out of a 

million would test positive for 6–AM 

and not have morphine that was present 

reported to the MRO. Therefore, Quest 

recommended that DOT provide 

additional guidance to MROs to speak 

with laboratories related to morphine 

that may be present but not reported by 

the laboratory. 

DOT Response 

As stated earlier in this document, the 

Department must follow the laboratory 

testing protocols and standards that are 

established by HHS. Therefore, we must 

adhere to the screening and 

confirmation drug testing cutoffs that 

HHS has established for the laboratories 

and for which the laboratories are 

certified. 

6–AM is a unique metabolite 

produced when a person uses the illicit 

drug heroin. 6–AM is both excreted in 

the urine and further metabolized to 

morphine. Morphine can also be 

excreted in the urine as a result of 

codeine or morphine use. Thus, 

morphine is a common metabolite of 

both heroin and codeine. 

It is well established that, in some 

instances, individuals who are positive 

for 6–AM are atypically low in the 

coincident morphine concentration 

found in urine. That is, their morphine 

concentrations are below the HHS/DOT 

cutoff of 2000 ng/mL and even below 

300 ng/mL. Therefore, testing programs 

focused on the morphine concentration 

as the screening discriminator will fail 

to identify a number of heroin users 

WReier-Aviles on DSKGBLS3C1PROD with RULES

49856 Federal Register / Vol. 75, No. 157 / Monday, August 16, 2010 / Rules and Regulations 

(estimated by some studies referenced 

in the docket to be about 10% of the 

opiate positives). 

While morphine positives in the 

absence of 6–AM require significant 

MRO intervention to differentiate 

legitimate morphine or codeine sources 

for morphine, 6–AM is a definitive 

marker for heroin use and thus requires 

no MRO intervention. There are simply 

no legitimate medical explanations for 

6–AM positive tests. Although there has 

been from time to time some anecdotal 

suggestion that 6–AM can be produced 

from morphine, existing scientific 

evidence does not support such a claim. 

The atypical finding of a 6–AM 

positive in the absence of significant 

morphine findings by CRL may be the 

result of recent heroin use close to the 

time of sampling, a metabolic defect in 

the metabolism of 6–AM resulting in 

prolonged excretion, shunting of 

metabolic pathways away from 

morphine, or interaction with other 

substances not identified. Therefore, the 

6–AM testing does not require 

confirmation by the simultaneous 

detection of a specified quantity of 

morphine. 

Multiple scientific publications have 

concluded that a portion of the 

population shows urinary 

concentrations of 6–AM above 10 ng/mL 

with morphine concentrations below 

300 ng/mL, even though the Quest study 

showed that none of their 6–AM 

positive results had morphine below a 

300 ng/mL cutoff. 

Therefore, the salient facts are: 

• 6–AM confirmed positive tests do 

not need a morphine marker; 

• Data show that when one looks for 

morphine as a marker, it most always 

exists above the morphine confirmation 

cutoffs or above Limit of Detection 

(LOD); and 

• If the morphine marker does not 

exist on a 6–AM positive result, there is 

ample scientific reason to strongly 

suggest recent heroin use. 

Despite these facts and until more 

information is gathered from DOT’s 

experience with 6–AM testing, when a 

6–AM confirmed positive result is 

reported and morphine for that 

specimen is not reported at or above the 

2000 ng/mL confirmed positive cutoff, 

the laboratory and MRO must confer to 

determine if there was confirmed 

morphine below the 2000 ng/mL, and if 

not, whether further testing is needed to 

quantify the amount of morphine 

present. The laboratory must report the 

amount of morphine from the test to the 

MRO. 

If a laboratory finds no detectable 

morphine at its LOD upon further 

testing, the laboratory must report that 

fact to DOT’s Office of Drug and Alcohol 

Policy and Compliance (ODAPC) 

immediately. Based upon the scientific 

evidence that exists today, we simply do 

not think that 6–AM with no morphine 

detected will occur. But we will 

determine what our first year of 6–AM 

screening and confirmation testing 

reveals in this matter. We would work 

directly with MROs on these cases, if 

there would be any. We would also 

work with HHS to determine if 

additional action is necessary. 

Ultimately, the MRO, with ODAPC’s 

assistance, would make a verified result 

determination following these 

discussions. 

Last year, HHS-certified laboratories 

conducted approximately 5.2 million 

DOT tests. Quest estimates that there 

will be 6 tests per one million that 

would be reported to MROs for 6–AM 

with morphine concentrations below 

the established confirmation cutoffs. 

Extrapolated, this would mean 

approximately 30 6–AM positive 

specimen tests a year will be reported to 

MROs with morphine below 2000 ng/ 

mL. As with other 6–AM positives, the 

MRO must not accept an assertion that 

there is a legitimate explanation for the 

presence of 6–AM in the employee’s 

specimen. 

Approval of Medical Review Officer 

Training and Examination Groups 

The HHS Mandatory Guidelines will 

require that nationally-recognized MRO 

certification entities or subspecialty 

boards for medical practitioners in the 

field of medical review must have their 

qualifications, training programs, and 

examinations approved by HHS on an 

annual basis. The Department requested 

comments on whether part 40 should 

require these groups to be approved and 

if the Department should seek a shared 

approval process with HHS. 

Comments 

Commenters were rather evenly 

divided about whether the Department 

should require or join the approval 

process of the nationally-recognized 

MRO certification and subspecialty 

boards. Some who support DOT’s 

involvement expressed concern that 

HHS would be the only approving 

authority if the Department does not 

share in that responsibility. Some who 

did not support the Department’s 

involvement in the approval process 

also tended not to support HHS 

approval of these boards, either. Some 

commenters offered suggestions about 

basic standards for national certification 

groups. 

DOT Response 

While we believe the current MRO 

training and examination boards have 

very strong standards, we want to be 

certain that these groups continue to 

present well and accurately the 

Department’s part 40 and DOT agency, 

including the USCG, drug rules. After 

all, no MRO wants to be in violation of 

the Department’s regulations because of 

erroneous information presented during 

training or on a certification 

examination. Consequently, it makes 

sense to consider the benefits of 

additional oversight of MRO 

certification groups. 

Some of the basic standards suggested 

by one commenter were very similar to 

our Subpart O requirements for national 

drug and alcohol counselor certification 

organizations. Our experience with 

these counselor certification 

organizations taught us that having 

standard requirements rules out upfront substandard counseling 

organizations. Our SAP experience also 

taught us that, from the beginning, the 

major MRO organizations had 

established highly reputable training 

and examination modalities. In fact, we 

used some of the MRO testing standards 

in laying out the examination 

requirements that SAP testing 

organizations now follow. 

We liked the idea submitted by one of 

the commenters for basic standards for 

the MRO certification organizations and 

will pass these ideas to HHS. However, 

we see no pressing need for the 

Department to use our limited staff time 

and personnel to participate in or 

require approval for these established 

organizations. Again, our experience has 

been that these national organizations 

effectively train, test, and certify MROs. 

As long as they continue to do so, and 

as long as there are no new MRO 

certification organizations on the 

horizon, we see no reason to expend 

additional resources approving those 

who have already demonstrated their 

competence. 

We will continue our practice of 

helping MRO training and examination 

groups to accurately update DOT’s 

portions of their course materials, 

manuals, and examination content. We 

believe our assistance will enable us to 

make sure that content is DOT-specific 

and accurate. 

We anticipate that HHS approval 

standards would include all Federal 

testing programs. However, we do not 

intend to become involved in this 

approval process, unless HHS identifies 

significant deficits with any of the 

training and examination efforts by any 

of these boards that affect DOT’s 

WReier-Aviles on DSKGBLS3C1PROD with RULES

Federal Register / Vol. 75, No. 157 / Monday, August 16, 2010 / Rules and Regulations 49857 

1 ‘‘Proctored Versus Unproctored Online Exams: 

Studying the Impact of Exam Environment on 

Student Performance,’’ Kimberly K. Hollister and 

Mark L. Berenson Decision Sciences Journal of 

Innovative Education Volume 7 Issue 1, Pages 271– 

294 Published Online: 16 Jan 2009 © 2010 Decision 

Sciences Institute. 

‘‘On-line instruction: Are the outcomes the 

same?’’ Warren, L., & Holloman, Jr., H. (2005). 

Journal of Instructional Psychology, 32(2), 148–151. 

‘‘Questioning the hybrid model: Student 

outcomes in different course formats’’ Reasons, S., 

Valadares, K., & Slavkin, M., Journal of 

Asynchronous Learning Networks, (2005) 9(1). 

‘‘Comparison of outcomes on like exams 

administered to in-residence and asynchronous 

distance-based Pharm. D. students.’’ Ragan, R. & 

Kleoppel, J. (2004). Journal of Asynchronous 

Learning Networks, 8(4). 

‘‘The Relationship Between Performance Levels 

and Test Delivery Methods,’’ Patricia Royal, Paul 

Bell; International Journal of Instructional 

Technology and Distance Learning, July 2008 Vol. 

5. No. 7. 

‘‘Traditional versus Online Content Delivery and 

Assessment,’’ Margaret D. Anderson and Mark 

Connell, International Journal of Instructional 

Technology and Distance Learning, February 2009, 

Vol. 6. No. 2. 

program. For now, DOT will not require 

these MRO training and examination 

organizations to obtain HHS approval. 

Furthermore, MROs in the DOT program 

will not be required to be trained by an 

HHS-approved group, as long as the 

MROs meet DOT’s qualification training 

and requalification training 

requirements. 

Some of the commenters noted that 

one MRO certification organization 

reportedly provides an on-line 

examination. These commenters ask the 

Department to put a stop to this practice 

by requiring only proctored testing. One 

commenter indicated that at least the 

examination for the initial MRO 

certification should be proctored. We 

will defer action on the issue of 

proctored versus on-line examinations 

until we know more about the HHS 

approval process. We would note, 

however, that the entire issue of 

proctored versus on-line examinations 

remains largely unresolved—with 

supporters in both corners and with 

studies and literature supporting both 

camps.1

Medical Review Officer Recurrent 

Requalification Training and 

Examination 

In our NPRM we sought comments on 

whether part 40, at 49 CFR 40.121(d), 

should be amended by removing the 

requirement that MROs must complete 

12 Continuing Education Units (CEUs) 

pertaining to DOT and MRO practices 

every three years, and instead require 

MROs to be requalified every five years 

by an MRO certification board or 

subspecialty board for medical 

practitioners. 

Comments 

Most commenters supported the idea 

that the Department require MROs to be 

requalified by being certified on a 

regular basis. Most also wanted DOT to 

continue to require MROs to have 

continuing education (or, Continuing 

Medical Education) related to their 

MRO work. Several commenters 

indicated that they did not see any 

benefit to changing the requirements, 

believing that initial qualification 

training and the continuing education 

requirement the Department established 

in 2000 has proven adequate. 

DOT Response 

Medical review of drug test results is 

more complex today than when we 

established the continuing education 

requirement in 2000. Therefore, we have 

decided to side with the overwhelming 

majority of commenters supporting 

MRO requalification training and 

reexamination on a regular basis. We 

will require MRO requalification every 

five years. However, to offset the 

associated costs, we will not maintain 

the requirement for continuing 

education. 

Over the years, it has been somewhat 

difficult for us to know whether the 12 

CEU hours obtained by many MROs 

every three years were indeed related to 

DOT’s testing program, as required. 

However, based on our experience to 

date, we believe that a requalification 

requirement every five years will assure 

DOT agency auditors and inspectors and 

regulated employers that MROs are 

appropriately qualified. 

We anticipate that MROs will 

continue to obtain CEUs by virtue of 

their MD and DO licensure 

requirements. In addition, the MRO 

certification boards provide their 

members with MRO manuals and 

periodic newsletters in an effort to keep 

everyone up-to-date on the 

Department’s program requirements. 

The MRO plays a key role in our 

important Federal safety program and 

maintains the Constitutionally 

mandated balance between the safety 

and privacy objectives of the program. 

The MRO’s role in gathering and 

evaluating the medical evidence and 

providing due process is imperative. 

These are duties that must be carried 

out by the MRO and cannot be delegated 

to anyone. 

The MRO is charged with certain 

important medical and administrative 

duties. The MRO must have detailed 

knowledge of the effects of medications 

and other potential alternative medical 

explanations for laboratory reported 

drug test results. He or she is 

responsible for determining whether 

legitimate medical explanations are 

available to explain an employee’s drug 

test result. This medical review process 

has become far more complex as a result 

of specimen validity testing and the 

myriad of medical explanations for 

adulterated, substituted, and invalid 

laboratory test results. These 

complexities have made MRO 

knowledge of the effects of drugs and 

medications even more important than 

it was in 2000. 

Part 40 also requires the MRO to 

confer with prescribing physicians in 

making decisions about prescription 

changes so that alternative medications 

can be used that will not impact public 

safety. Similarly, the MRO is required to 

report to employers the employees’ 

prescription and over-the-counter 

medication use (or dangerous 

combinations of use) that the MRO 

believes will negatively affect duty 

performance. In addition, the MRO is 

required to medically assess referral 

physician examinations and evaluations 

in certain positive and refusal-to-test 

situations. These, too, have become 

more complex over time. 

For these reasons, we think 

qualification training and examination 

followed by requalification and an 

examination every five years will be 

much more effective than the current 

one-time training and examination 

requirement with periodic CEUs. To 

ensure that MROs are well qualified, the 

requalification process must be very 

similar to the original qualification 

training (i.e., a full training program 

addressing all issues required by part 

40) and an examination administered by 

a nationally recognized MRO 

certification board or subspecialty board 

for medical practitioners in the field of 

medical review of DOT-mandated drug 

tests. A mere ‘‘update’’ type of training 

will be considered a violation of part 40. 

This regulation text lays out the 

requirements for when this new 

requalification training is to take place. 

MROs must maintain documentation 

about their qualification training and 

any subsequent continuing education. 

MROs would simply be required to 

complete the new requalification 

training and examination no later than 

five years from the date of having last 

met either their qualification training or 

continuing education requirements. 

Following the completion of the new 

requalification requirements, MROs will 

be required to complete requalification 

training and examination every five 

years thereafter. 

DOT will continue to use the term 

‘‘qualification training’’ rather than 

‘‘certification training’’ and will use 

WReier-Aviles on DSKGBLS3C1PROD with RULES

49858 Federal Register / Vol. 75, No. 157 / Monday, August 16, 2010 / Rules and Regulations 

‘‘requalification training’’ rather than 

‘‘recertification training’’ in part 40. 

Medical Review Officer Records 

Maintenance 

In the NPRM we asked for discussion 

related to MRO records; primarily we 

asked what documentation of 

consultation and deliberation should be 

in MRO records. In the NPRM, we stated 

that our current recordkeeping 

requirements for negative and nonnegative test results would not change 

based upon the new HHS MRO 

recordkeeping requirements. 

Comments 

Six commenters addressed the issue 

of MRO records. All supported the idea 

that MROs should keep records and that 

the time frame should be the same as 

that required for employers. 

One association said that DOT 

inspectors are not qualified to question 

MRO judgments regarding medical 

information and its relevance. Another 

commenter indicated that personal 

information, which was not defined, 

should be confidential and not part of 

the MRO file. This same commenter 

provided a long list of items that should 

be part of the record, including various 

dates and times of MRO contacts and 

conversations with various Designated 

Employer Representatives (DERs), 

collectors, and employers. In addition, 

this commenter believed that 

information should be included related 

to contacts with other physicians, 

laboratories, and pharmacies, although 

without specific detail. 

DOT Response 

The DOT agrees with commenters that 

MRO records are very important and 

integral to the MRO review process. We 

believe that records and notes generated 

by the review process need to be 

maintained. The purpose of any record 

is to ensure that proper procedures and 

results were achieved under part 40 

requirements. MRO records must show 

why a particular specimen is negative or 

non-negative. At times, the test result 

must withstand legal challenges. 

DOT regulations already require 

MROs to follow the employer’s record 

retention requirements—five years for 

non-negatives and one year for 

negatives. Those will not change. 

The notes recorded by the MRO are 

considered by the Department to be part 

of the record. These notes generally 

contain all the information that was 

discussed by the MRO with the 

employee and any supplemental 

information the MRO uses to support 

the various reasons the employee 

provides as legitimate medical 

explanation for a non-negative result. 

The MRO records may include copies of 

prescriptions, letters from other 

physicians, and consultations by the 

MRO with physicians, pharmacy 

personnel, laboratory personnel, and 

other appropriate individuals. 

However, a listing of these contacts 

without specific references as to what 

was discussed would not be effective. 

There must be a specific comment or 

rationale to which the MRO can 

subsequently refer for support and 

reasoning about the outcome of the 

verification process. This is especially 

true if a decision is challenged in a 

court or an administrative hearing 

proceeding. 

During the verification interview, the 

employee may share personal 

information. Unless a specific issue, 

such as the use of psychotropic 

medication, is used as a medical 

explanation for a drug positive, the 

MRO should not include the other 

sensitive, unrelated personal 

information in the record. From a 

practical point of view, MROs will 

primarily record information that is 

specific to the issue at hand or may have 

an impact upon safety. The Department 

is comfortable that MROs are trained, 

both in their role as physicians and as 

MROs, to maintain a clear balance 

between recording of pertinent 

information versus not recording 

sensitive information which is not 

relevant to the verification process or 

transportation safety. 

In reference to inspectors’ 

qualifications to question MROs 

medical decisions, we want to point out 

that the purpose of an inspection is not 

to challenge a physician’s medical 

expertise, but rather to ensure that the 

MRO is abiding by regulations and 

current requirements. In most cases, the 

issue would be whether there is 

adequate documentation for whatever 

action the MRO took. For example, if 

the MRO had his or her staff confer with 

the pharmacist or a prescribing 

physician—instead of doing so himself 

or herself, as the regulations require— 

the MRO’s procedures would be 

contrary to part 40. 

When a positive result is downgraded 

to a negative result, the inspector would 

look at the reason for this downgrade. If 

there is a legitimate medical 

explanation, the inspector would expect 

to see this clearly spelled out in the 

record. For example, if a THC positive 

confirmed laboratory result were 

downgraded to negative because of an 

explanation of ‘‘medical marijuana’’ use, 

the inspector would rightfully view that 

as a serious matter, because it remains 

unacceptable for any safety-sensitive 

employee subject to DOT drug testing 

rules to use marijuana. 

Additional areas of concern by DOT 

inspectors and auditors focus upon the 

person(s) who actually talk(s) with the 

employee following a non-negative 

result (e.g., the MRO vs. the MRO staff), 

how requests for split specimen testing 

are handled and whether requests are 

handled in timely manner, and how 

DERs are notified about non-negative 

results. The Department also knows that 

inspectors and auditors are trained to 

address all of these issues, and they are 

sensitive to the fact that these MRO 

records contain medical information 

and that they must be handled 

appropriately. We want to reaffirm that 

inspecting and auditing MRO records 

has been, and will continue to be, one 

of the mechanisms that inspectors and 

auditors use to ensure compliance with 

DOT regulations. 

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. 

Table of Contents 

The Department proposed, in the 

NPRM, to modify some existing section 

headings in order to reflect regulation 

text changes. In all, three section 

headings have been modified and one 

has been added. § 40.3, § 40.87, and 

§ 40.139 have been revised, and § 40.140 

has been added. 

Section 40.3 What do the terms in this 

part mean? 

In order to align more closely the 

definitions in § 40.3 with definitions 

contained in the HHS Mandatory 

Guidelines, in the NPRM, the 

Department proposed modifying some 

existing definitions and adding several 

new ones. 

Five commenters supported this 

proposal and responded by making 

suggested additions or changes to this 

section. Several commenters did not 

support the changes, contending that 

the Department should not allow DOTregulated employers to use IITFs. 

Because the Department is not allowing 

IITFs, no definitions related to IITFs 

will be added. A few commenters did 

not want the Department to change its 

definition of ‘‘cancelled test’’ because 

the proposed definition was confusing. 

After reviewing the comments the 

Department agrees with the commenters 

and will keep the current definition of 

‘‘cancelled test.’’ Other commenters did 

not want the Department to add 

definitions that were only applied to the 

HHS program and not to the DOT 

WReier-Aviles on DSKGBLS3C1PROD with RULES

Federal Register / Vol. 75, No. 157 / Monday, August 16, 2010 / Rules and Regulations 49859 

program. We have reviewed those 

definitions and decided that most will 

be in the regulation. It is necessary to 

harmonize our terms with HHS 

definitions, in order that laboratories 

and others in the drug testing industry 

have consistent terms with which to 

operate. 

In all, 13 definitions will be modified 

or added to harmonize with HHS 

definitions, and one will be removed. 

The new or modified definitions are 

‘‘Adulterated specimen,’’ ‘‘Confirmatory 

drug test,’’ ‘‘Initial drug test (also known 

as a Screening drug test),’’ ‘‘Initial 

specimen validity test,’’ ‘‘Invalid drug 

test,’’ ‘‘Laboratory,’’ ‘‘Limit of Detection 

(LOD),’’ ‘‘Limit of Quantitation,’’ 

‘‘Negative result,’’ ‘‘Positive result,’’ 

‘‘Reconfirmed,’’ ‘‘Rejected for testing,’’ 

and ‘‘Split specimen collection.’’ The 

term ‘‘Initial validity test’’ was removed. 

Section 40.87 What are the cutoff 

concentrations for drug tests? 

The Department will require 

conducting initial and confirmation 

testing for MDMA, MDA, and MDEA, 

conducting initial testing for 6–AM, 

lowering the initial and confirmation 

cutoff concentrations for amphetamines, 

and lowering the initial and 

confirmation cutoff concentrations for 

cocaine. We include certain instructions 

for laboratories (and MROs) related to 

6–AM testing. Specific discussions of 

these issues are included under 

‘‘Principal Policy Issues’’ in this 

preamble. 

Section 40.97 What do laboratories 

report and how do they report it? 

The Department added a paragraph to 

this section instructing the laboratory to 

contact ODAPC if it ever confirms 6– 

AM with no detectable morphine at its 

LOD, upon further testing. A fuller 

discussion of this matter is in ‘‘Principal 

Policy Issues.’’ 

Section 40.121 Who is qualified to act 

as an MRO? 

Commenters had a number of 

suggestions related to ongoing training 

for MROs. The DOT reviewed the 

comments and, as discussed in the 

‘‘Principal Policy Issues,’’ will require 

MRO requalification, including training 

and examination, every five years. 

Section 40.139 On what basis does the 

MRO verify test results for codeine and 

morphine? 

The Department has revised this 

section by limiting the section to how 

MROs are to verify laboratory-confirmed 

codeine and morphine test results. We 

removed 6–AM verification from this 

section and moved it to a new section. 

We also revised the section’s heading. 

Section 40.140 On what basis does the 

MRO verify test results for 6- 

acetylmorphine (6–AM)? 

This new section provides 

instructions to MROs on how they are 

to verify confirmed positive 6–AM 

results from laboratories. Instructions 

include how MROs are to handle 6–AM 

confirmed positive results when 

morphine is above the confirmation 

cutoff, when morphine is confirmed 

below the confirmation cutoff, when 

morphine is confirmed above LOD, and 

if ever morphine is not detected at LOD 

upon further testing. A fuller discussion 

of this matter is in ‘‘Principal Policy 

Issues.’’ 

Section 40.151 What are MROs 

prohibited from doing as part of the 

verification process? 

The Department has revised this 

section by adding MDMA, MDA, and 

MDEA as being among the drugs for the 

presence of which there exist no 

legitimate medical explanations. This 

instruction is consistent with what the 

Department has said about PCP and 6– 

AM. 

Section 40.159 What does the MRO do 

when a drug test is invalid? 

In response to the commenters’ 

concerns related to pH, this section is 

based on a July 2008 guidance 

authorizing MROs to consider time and 

temperature in making their verification 

decisions if pH is in the 9.0–9.5 range. 

A fuller discussion of this matter is in 

‘‘Principal Policy Issues.’’ 

Section 40.163 How does the MRO 

report drug test results? 

The majority of the commenters 

wanted DOT to be clear about the 

records MROs should keep and how 

long MROs should keep them. Based 

upon the comments, we have decided to 

put more specificity about this issue 

into the MRO rule text section. MROs 

keep negative and cancelled drug test 

reports and records for one year, and all 

positive and refusal drug test reports 

and records for five years. A fuller 

discussion of this matter is in ‘‘Principal 

Policy Issues.’’ 

Appendix B to Part 40—DOT Drug 

Testing Semi-Annual Laboratory Report 

to Employers 

The Department has modified the 

requirements for the semi-annual 

laboratory reports to employers. The 

changes require laboratories to also 

report the total number of MDMA, 

MDA, and MDEA positive drug test 

results. 

Appendix C to Part 40—DOT Drug 

Testing Semi-Annual Laboratory Report 

to DOT 

The Department has modified the 

requirements for the semi-annual 

laboratory reports to DOT. The changes 

require laboratories to also delineate the 

positives for the newly added MDMA, 

MDA, and MDEA. We are also breaking 

out the other drugs for which we test in 

order to make it simpler for laboratories 

to report and for our staff to tally the 

reports. 

Other Issues 

There were several comments that 

addressed editorial changes and 

included typographical errors. We 

appreciate these comments and 

incorporated a good many of the 

suggestions and edits. 

The Department also received several 

comments that we consider to be 

outside of the scope for this rulemaking. 

However, in order to try to bring closure 

to these issues, we will provide some 

explanation and clarification. 

One commenter said that section 

40.25 stated that the employer was 

required to obtain consent from the 

applicant, but the commenter believed 

that section 40.27 prohibited the 

employer from obtaining consent for 

release of the 40.25 information. We 

would like to point out that section 

40.25 requires the employee to sign this 

written consent in order to perform 

safety-sensitive duties and is very 

specific as to the purpose of this 

consent. Section 40.27 prohibits an 

employer from requiring the employee 

to sign a form consenting to 

participation in the program, a blanket 

release form for all drug and alcohol 

testing information, or any type of 

waiver of indemnification or liability. 

There is no contradiction between these 

two requirements. 

Another commenter believed that the 

HHS employer option for a second 

collection, if the first test result was 

‘‘negative dilute,’’ was not adopted by 

DOT. We would point out that this 

authorization has already been part of 

our rule for some time and is clearly 

spelled out in section 40.197. 

One commenter wanted the 

Department to establish a time limit on 

how long an employee had to wait at a 

collection site before providing a urine 

specimen. This commenter thought that 

two hours should be the maximum 

timeframe an employee had to wait to 

provide a specimen. This same 

commenter also wanted clarification 

about what constituted a ‘‘drug failure’’ 

WReier-Aviles on DSKGBLS3C1PROD with RULES

49860 Federal Register / Vol. 75, No. 157 / Monday, August 16, 2010 / Rules and Regulations 

and that leaving the collection site for 

a short time should not be considered a 

refusal, unless the employee left the 

collection area where the urine sample 

is actually taken. Additionally, this 

commenter wanted some grievance 

procedures to be established should 

there be problems at a collection site. 

Although this commenter was 

concerned about how long an employee 

may have to wait to provide a specimen, 

we would like to emphasize that section 

40.61(b) clearly directs the collection 

site to ‘‘begin the testing process without 

undue delay.’’ The Department’s 

position has always been that testing 

should start as soon as possible after the 

employee’s arrival at the site. The 

Department’s position has always been 

that the employee cannot leave the 

collection site, i.e., the waiting area, 

even for a short time. Leaving the site 

provides employees the opportunity to 

adulterate or substitute their specimens. 

And finally, collection site problems 

encountered by employees should be 

raised to the employer following the 

collection. The employer is ultimately 

responsible for the proper operation of 

its drug testing program. 

One association asked for clarification 

as to what the Department intended by 

the term ‘‘same business day’’ as it 

applies under section 40.205. This 

section directs that if a problem is 

identified in the testing process, anyone 

involved in it should make an attempt 

to correct the problem on the same 

business day that notification is 

received about the problem. This 

commenter provided several scenarios 

where the employer, the collection site, 

or the service agent offices are closed, 

but the information is transmitted to 

them. The question is how these entities 

can meet the requirement of responding 

on the same day that they are notified 

about a problem. 

If an office is closed when 

information is received, common sense 

dictates that the next day the office is 

open is the business day it is received. 

Several commenters asked about other 

HHS Mandatory Guidelines procedures 

and whether the Department would 

adopt them. As discussed in the NPRM, 

the Department identified those HHS 

Mandatory Guidelines we proposed to 

adopt and which ones we did not. In 

this final rule, we have again 

highlighted those we have adopted. 

For example, the Department will not 

require observers to receive advanced, 

formalized training to learn about the 

steps necessary to directly observe a 

collection. The current process of 

having a qualified and trained collector 

provide immediate, precise, and 

relevant instructions to an observer at 

the time of a directly observed 

collection is very appropriate and 

effective and has been for years. That 

way, the Department can be assured that 

the requisite instructions are provided 

each time that direct observation is 

required, no matter how many, or few, 

an observer has already accomplished. 

In addition, the costs associated with 

formally training observers (and the 

resulting limitation on available 

observers) does not outweigh any 

minimal benefits to arguably be 

obtained by training observers in 

advance instead of providing timely and 

relevant instructions on site at the time 

direct observation is required. The 

Department is not aware of any cases 

where it was not effective to have the 

qualified and trained collector instruct 

the observer at the time a direct 

observation must occur, and to do so 

each and every time, no matter whether 

the observer has already been trained 

and properly informed. 

Also, DOT will not change our 

longstanding regulatory position that a 

collector need not obtain prior approval 

from a collection site supervisor before 

performing a directly observed 

collection. Requiring collectors to get 

approval from collection site 

supervisors would create difficult 

logistical issues that would complicate 

the process. There are numerous 

instances where the collector is alone or 

does not have immediate access to a 

collection site supervisor. In fact, the 

collector may be the site supervisor. 

Many collections occur off-site or in the 

middle of the night, where and when 

supervisors would not be available, and 

requiring consultation with an 

unavailable supervisor would prove 

onerous and serve only to delay the 

process unnecessarily. We believe 

qualified collectors should continue to 

make these direct observation collection 

decisions and to continue basing those 

decisions upon the clear requirements 

set forth in part 40. 

Also, we will not change the duration 

of the paperwork retention requirement 

for collectors. HHS will require 

collectors to keep Copy 3 for two years. 

The Department believes the current 30 

days is sufficient in DOT’s program. 

Retention for 30 days has proven a 

sufficient amount of time in which to 

ensure that a CCF copy with the 

employee’s signature would be available 

to the MRO when the MRO’s CCF copy 

was not available. Requiring document 

retention for two years would greatly 

increase the paperwork burden without 

any added safety or efficiency benefit. 

Under the revised HHS Mandatory 

Guidelines, Federal agencies will be 

required to audit five percent or a 

maximum of 50 of their collection sites 

annually. The Department believes that 

creating a parallel requirement for 

transportation industry employers 

would be very expensive to employers 

in DOT’s program in terms of time and 

resources, with few efficiency and/or 

safety benefits. The Department would 

anticipate seeing more effective 

monitoring by the collection site parent 

organizations in an effort to ensure for 

employers that sites under their 

organization umbrellas, with which 

employers are contracting, are properly 

conducting collections. The DOT 

agencies and the U.S. Coast Guard also 

provide on-site audits and inspections 

of collection sites. They have also 

increased their mock collection 

inspections and their clandestine 

inspections. All of these provide added 

oversight to determine whether 

collection site personnel are properly 

performing collections and whether 

collection sites adhere to DOT’s strong 

security and integrity requirements. 

The revised HHS Mandatory 

Guidelines will require at least three 

percent blind specimen testing, 

compared to DOT’s current one percent. 

We believe our current requirements 

represent a good balance between 

considerations of reducing burdens and 

maintaining an effective check upon 

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. Coupled with the 

HHS requirements and the additional 

proficiency testing required for 

laboratory certification, the blinds 

submitted to laboratories for quality 

control testing purposes via DOT 

requirements are quite ample. 

In the NPRM, the Department 

estimated the total annual cost of testing 

for MDMA and 6–AM to be $1,361,063. 

One commenter believed that estimate 

to be too low, but did not offer any 

recommended cost figure. We believe 

there will be approximately 5 million 

DOT tests per year, and an MDMA test 

will cost on average $ 0.09 per test, and 

6–AM will cost on average $.26 per test. 

MDMA will cost approximately $450 

thousand per year, and 6–AM will cost 

approximately $1.3 million per year, for 

a total of $1.75 million per year. 

Regulatory Analyses and Notices 

The statutory authority for this rule 

derives from the Omnibus 

Transportation Employee Testing Act of 

1991 (49 U.S.C. 102, 301, 322, 5331, 

20140, 31306, and 45101 et seq.) and the 

WReier-Aviles on DSKGBLS3C1PROD with RULES

Federal Register / Vol. 75, No. 157 / Monday, August 16, 2010 / Rules and Regulations 49861 

Department of Transportation Act (49 

U.S.C. 322). 

The Department estimates there will 

be approximately 5 million DOT tests 

per year. An MDMA test will cost on 

average $0.09 per test, and 6–AM will 

cost on average $.26 per test. MDMA 

will cost approximately $450 thousand 

per year, and 6–AM will cost 

approximately $1.3 million per year, for 

a total of $1.75 million per year. Based 

upon the data discussed in the 

‘‘Principal Policy Issues,’’ the increased 

detection of amphetamine, 

methamphetamine, and cocaine use 

through drug testing is estimated to be 

approximately 30% more for 

amphetamines/methamphetamines, and 

30% more for cocaine. In 2009, HHScertified laboratories reported to DOT 

that there were 14,195 confirmed DOT 

positive results for amphetamines/ 

methamphetamines. So, we estimate an 

increase of over 4,000 confirmed 

positive amphetamine/ 

methamphetamine test results. Also in 

2009, laboratories reported 12,918 DOT 

cocaine confirmed positive results. 

Therefore, we estimate an increase of 

nearly 4,000 confirmed cocaine results. 

We estimate the cost associated with 

this increase of 8,000 positive test 

results for cocaine and amphetamines/ 

methamphetamines to be $500 

thousand. The total program cost of the 

new regulation will be $2.25 million. 

It stands to reason that it will be cost 

beneficial to identify the illegal drug use 

of an additional 8,000 safety-sensitive 

transportation employees annually, 

across all modes—on roads, rails, water, 

or in the air, over land and 

underground. Furthermore, if 

identifying the illicit drug use by these 

employees prevents a single serious 

accident, then the economic benefits of 

the rule will outweigh its costs. As we 

have stated throughout this preamble, 

the Omnibus Act requires us to follow 

HHS on these specific drug testing 

matters. 

We have concluded that this rule is 

not significant for purposes of Executive 

Order 12866 or DOT’s regulatory 

policies and procedures. In addition to 

its low costs, it modifies our overall part 

40 procedures and is intended to further 

align our laboratory procedures and 

processes, as well as some collection 

and MRO procedures, in order to 

harmonize DOT procedures with 

requirements that are being directed by 

HHS Mandatory Guidelines, which were 

themselves deemed to be nonsignificant rules. The DOT also certifies, 

under the Regulatory Flexibility Act, 

that this rule will not have a significant 

economic impact on a substantial 

number of small entities. Given the 

small net change in regulatory costs 

compared to the present rule, spread 

over the many thousands of small 

entities in the transportation industries, 

the cost impact per entity is expected to 

be negligible. 

There are no new information 

collection requirements that would be 

subject to the Paperwork Reduction Act. 

This rule has been analyzed in 

accordance with the principles and 

criteria contained in Executive Order 

13132 (‘‘Federalism’’). This rule does not 

include requirements that (1) have 

substantial direct effects on the States, 

the relationship between the national 

government and the States, or the 

distribution of power and 

responsibilities among the various 

levels of government, (2) impose 

substantial direct compliance costs on 

State and local governments, or (3) 

preempt State law. Therefore, the 

consultation and funding requirements 

of Executive Order 13132 do not apply. 

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. 

49 CFR subtitle A, Authority and 

Issuance. 

Issued August 10, 2010, at Washington DC. 

Ray LaHood, 

Secretary of Transportation. 

■ For reasons discussed in the 

preamble, the Department of 

Transportation amends Title 49 of the 

Code of Federal Regulations, 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: 40 U.S.C. 102, 301, 322, 5331, 

20140, 31306, and 54101 et seq. 

* * * * * 

■ 2. § 40.3 is amended as follows: 

■ A. Revise the section heading. 

■ B. Revise the definitions of 

Adulterated specimen, Confirmatory 

drug test, Initial drug test (also known 

as a Screening drug test), Invalid drug 

test, Laboratory, and Limit of detection 

(LOD). 

■ C. Add in alphabetical order 

definitions of Initial specimen validity 

test, Limit of Quantitation, Negative 

result, Positive result, Reconfirmed, 

Rejected for testing, and Split specimen 

collection. 

■ D. Remove the definition of Initial 

validity test. 

The revisions and additions read as 

follows: 

§ 40.3 What do the terms used in this part 

mean? 

* * * * * 

Adulterated specimen. A specimen 

that has been altered, as evidenced by 

test results showing either a substance 

that is not a normal constituent for that 

type of specimen or showing an 

abnormal concentration of an 

endogenous substance. 

* * * * * 

Confirmatory drug test. A second 

analytical procedure performed on a 

different aliquot of the original 

specimen to identify and quantify the 

presence of a specific drug or drug 

metabolite. 

* * * * * 

Initial drug test (also known as a 

‘‘Screening drug test’’). The test used to 

differentiate a negative specimen from 

one that requires further testing for 

drugs or drug metabolites. 

Initial specimen validity test. The first 

test used to determine if a urine 

specimen is adulterated, diluted, 

substituted, or invalid. 

Invalid drug test. The result reported 

by an HHS-certified laboratory in 

accordance with the criteria established 

by HHS Mandatory Guidelines when a 

positive, negative, adulterated, or 

substituted result cannot be established 

for a specific drug or specimen validity 

test. 

* * * * * 

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. 

* * * * * 

Limit of Detection (LOD). The lowest 

concentration at which a measurand can 

be identified, but (for quantitative 

assays) the concentration cannot be 

accurately calculated. 

Limit of Quantitation. For quantitative 

assays, the lowest concentration at 

which the identity and concentration of 

the measurand can be accurately 

established. 

* * * * * 

Negative result. The result reported by 

an HHS-certified laboratory to an MRO 

when a specimen contains no drug or 

the concentration of the drug is less 

than the cutoff concentration for the 

WReier-Aviles on DSKGBLS3C1PROD with RULES

49862 Federal Register / Vol. 75, No. 157 / Monday, August 16, 2010 / Rules and Regulations 

drug or drug class and the specimen is 

a valid specimen. 

* * * * * 

Positive result. The result reported by 

an HHS-certified laboratory when a 

specimen contains a drug or drug 

metabolite equal to or greater than the 

cutoff concentrations. 

* * * * * 

Reconfirmed. The result reported for 

a split specimen when the second 

laboratory is able to corroborate the 

original result reported for the primary 

specimen. 

* * * * * 

Rejected for testing. The result 

reported by an HHS-certified laboratory 

when no tests are performed for a 

specimen because of a fatal flaw or a 

correctable flaw that is not corrected. 

* * * * * 

Split specimen collection. A 

collection in which the urine collected 

is divided into two separate specimen 

bottles, the primary specimen (Bottle A) 

and the split specimen (Bottle B). 

* * * * * 

■ 3. In § 40. 87, the section heading and 

paragraph (a) are revised, and paragraph 

(e) is added, to read as follows: 

§ 40.87 What are the cutoff concentrations 

for drug tests? 

(a) As a laboratory, you must use the 

cutoff concentrations displayed in the 

following table for initial and 

confirmatory drug tests. All cutoff 

concentrations are expressed in 

nanograms per milliliter (ng/mL). The 

table follows: 

Initial test analyte Initial test cutoff concentration Confirmatory test analyte Confirmatory test cutoff concentration 

Marijuana metabolites .................... 50 ng/mL ....................................... THCA1 .......................................... 15 ng/mL. 

Cocaine metabolites ...................... 150 ng/mL ..................................... Benzoylecgonine .......................... 100 ng/mL. 

Opiate metabolites 

Codeine/Morphine2 ........................ 2000 ng/mL ................................... Codeine ........................................ 2000 ng/mL.

Morphine ....................................... 2000 ng/mL. 

6–Acetylmorphine .......................... 10 ng/mL ....................................... 6–Acetylmorphine ......................... 10 ng/mL. 

Phencyclidine ................................. 25 ng/mL ....................................... Phencyclidine ................................ 25 ng/mL. 

Amphetamines3

AMP/MAMP4 .......................... 500 ng/mL ..................................... Amphetamine ................................ 250 ng/mL. 

Methamphetamine5 ...................... 250 ng/mL. 

MDMA6 .......................................... 500 ng/mL ..................................... MDMA ........................................... 250 ng/mL. 

MDA7 ............................................ 250 ng/mL. 

MDEA8 .......................................... 250 ng/mL 

1 Delta-9-tetrahydrocannabinol-9-carboxylic acid (THCA). 

2 Morphine is the target analyte for codeine/morphine testing. 

3Either a single initial test kit or multiple initial test kits may be used provided the single test kit detects each target analyte independently at 

the specified cutoff. 4 Methamphetamine is the target analyte for amphetamine/methamphetamine testing. 

5To be reported positive for methamphetamine, a specimen must also contain amphetamine at a concentration equal to or greater than 100 

ng/mL. 6 Methylenedioxymethamphetamine (MDMA). 

7 Methylenedioxyamphetamine (MDA). 

8 Methylenedioxyethylamphetamine (MDEA). 

* * * * * 

(e) On a 6–AM confirmed positive 

result: 

(1) When a 6–AM confirmed positive 

result is reported and morphine for that 

specimen is not reported at or above the 

2000 per ng/mL confirmed positive 

cutoff, you must confer with the MRO 

to determine if there was confirmed 

morphine below 2000 ng/mL. 

(2) If morphine was not confirmed 

below 2000 ng/mL, you and the MRO 

must determine whether further testing 

is needed to quantify the amount of 

morphine concentration present. 

(3) If you find no detectable morphine 

at LOD upon further testing, you must 

report that fact to ODAPC immediately. 

■ 4. In § 40.97, paragraph (g) is added to 

read as follows: 

§ 40.97 What do laboratories report and 

how do they report it? 

* * * * * 

(g) If you confirm 6–AM and find no 

detectable morphine at LOD upon 

further testing, you must report that fact 

to ODAPC immediately. 

■ 5. In § 40.121, paragraph (d) is revised 

to read as follows: 

§ 40.121 Who is qualified to act as an 

MRO? 

* * * * * 

(d) Requalification Training. During 

each five-year period from the date on 

which you satisfactorily completed the 

examination under paragraph (c)(2) of 

this section or have successfully 

completed the required continuing 

education requirements which were 

mandatory prior to October 1, 2010, you 

must complete requalification training. 

(1) This requalification training must 

meet the requirements of the 

qualification training under paragraph 

(c)(1) of this section. 

(2) Following your completion of 

requalification training, 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. 

* * * * * 

■ 6. § 40.139 is revised to read as 

follows: 

§ 40.139 On what basis does the MRO 

verify test results for codeine and 

morphine? 

As the MRO, you must proceed as 

follows when you receive a laboratory 

confirmed positive morphine or codeine 

test result: 

(a) 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. 

WReier-Aviles on DSKGBLS3C1PROD with RULES

Federal Register / Vol. 75, No. 157 / Monday, August 16, 2010 / Rules and Regulations 49863 

(b) 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 

professional and ethical judgment and 

discretion to determine whether there is 

clinical evidence of unauthorized use of 

opiates. Examples of information that 

you may consider in making this 

judgment 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 

(b)(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 

(b)(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 paragraph (b) of this 

section. 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. 

■ 7. A new § 40.140 is added to read as 

follows: 

§ 40.140 On what basis does the MRO 

verify test results for 6-acetylmorphine (6– 

AM)? 

As the MRO, you must proceed as 

follows when you receive a laboratory 

confirmed 6–AM test result: 

(a) If the laboratory confirms the 

presence of 6–AM in the specimen and 

there is also any level of quantitation of 

morphine, you must verify the test 

result positive. 

(b) When a laboratory 6–AM 

confirmed positive result is reported 

and morphine for that specimen is not 

reported at or above the 2000 per ng/mL 

confirmed positive cutoff, you must 

confer with the laboratory to determine 

if there was confirmed morphine below 

2000 ng/mL. 

(1) If there was confirmed morphine 

below 2000 ng/mL, you must verify the 

test result positive. 

(2) If morphine was not confirmed 

below 2000 ng/mL, you and the 

laboratory must determine whether 

further testing is needed to quantify the 

amount of morphine present. 

(c) If a laboratory finds detectable 

morphine at its LOD upon further 

testing, you must verify the test result 

positive. 

(d) If a laboratory finds no detectable 

morphine at its LOD upon further 

testing, you and the laboratory must 

report that fact to the ODAPC 

immediately. Following your discussion 

with ODAPC, you will make a verified 

result determination. 

■ 8. In § 40.151, paragraph (g) is revised 

to read as follows: 

§ 40.151 What are MROs prohibited from 

doing as part of the verification process? 

* * * * * 

(g) You must not accept an assertion 

that there is a legitimate medical 

explanation for the presence of PCP, 6– 

AM, MDMA, MDA, or MDEA in a 

specimen. 

* * * * * 

■ 9. In § 40.159, paragraph (a)(6) is 

added to read as follows: 

§ 40.159 What does the MRO do when a 

drug test is invalid? 

(a) * * * 

(6) When the test result is invalid 

because pH is greater than or equal to 

9.0 but less than or equal to 9.5 and the 

employee has no other medical 

explanation for the pH, you should 

consider whether there is evidence of 

elapsed time and increased temperature 

that could account for the pH value. 

(i) You are authorized to consider the 

temperature conditions that were likely 

to have existed between the time of 

collection and transportation of the 

specimen to the laboratory, and the 

length of time between the specimen 

collection and arrival at the laboratory. 

(ii) You may talk with the collection 

site and laboratory to discuss time and 

temperature issues, including any 

pertinent information regarding 

specimen storage. 

(iii) If you determine that time and 

temperature account for the pH value, 

you must cancel the test and take no 

further action, as provided at paragraph 

(a)(4) of this section. 

(iv) If you determine that time and 

temperature fail to account for the pH 

value, you must cancel the test and 

direct another collection under direct 

observation, as provided at paragraph 

(a)(5) of this section. 

* * * * * 

■ 10. In § 40.163, paragraph (h) is added 

to read as follows: 

§ 40.163 How does the MRO report drug 

test results? 

* * * * * 

(h) You must maintain reports and 

records related to negatives and 

cancelled results for one year; you must 

maintain reports and records related to 

positives and refusals for five years, 

unless otherwise specified by applicable 

DOT agency regulations. 

■ 11. Appendix B to part 40 is revised 

to read as follows: 

Appendix B to Part 40—DOT Drug 

Testing Semi-Annual Laboratory 

Report to Employers 

The following items are required on each 

laboratory report: 

Reporting Period: (inclusive dates) 

Laboratory Identification: (name and address) 

Employer Identification: (name; may include 

Billing Code or ID code) 

C/TPA Identification: (where applicable; 

name and address) 

1. Specimen Results Reported (total number) 

By Test Reason 

(a) Pre-employment (number) 

(b) Post-Accident (number) 

(c) Random (number) 

(d) Reasonable Suspicion/Cause (number) 

(e) Return-to-Duty (number) 

(f) Follow-up (number) 

(g) Type of Test Not Noted on CCF 

(number) 

2. Specimens Reported 

(a) Negative (number) 

(b) Negative and Dilute (number) 

3. Specimens Reported as Rejected for 

Testing (total number) 

By Reason 

(a) Fatal flaw (number) 

(b) Uncorrected Flaw (number) 

4. Specimens Reported as Positive (total 

number) By Drug 

(a) Marijuana Metabolite (number) 

(b) Cocaine Metabolite (number) 

(c) Opiates (number) 

(1) Codeine (number) 

(2) Morphine (number) 

WReier-Aviles on DSKGBLS3C1PROD with RULES

49864 Federal Register / Vol. 75, No. 157 / Monday, August 16, 2010 / Rules and Regulations 

(3) 6–AM (number) 

(d) Phencyclidine (number) 

(e) Amphetamines (number) 

(1) Amphetamine (number) 

(2) Methamphetamine (number) 

(3) MDMA (number) 

(4) MDA (number) 

(5) MDEA (number) 

5. Adulterated (number) 

6. Substituted (number) 

7. Invalid Result (number) 

■ 12. Appendix C to part 40 is revised 

to read as follows: 

Appendix C to Part 40—DOT Drug 

Testing Semi-Annual Laboratory 

Report to DOT 

Mail, fax, or e-mail to: U.S. Department of 

Transportation, Office of Drug and Alcohol 

Policy and Compliance, W62–300, 1200 New 

Jersey Avenue, SE., Washington, DC 20590. 

Fax: (202) 366–3897. E-mail: 

ODAPCWebMail@dot.gov. 

The following items are required on each 

report: 

Reporting Period: (inclusive dates) 

Laboratory Identification: (name and address) 

1. DOT Specimen Results Reported (total 

number) 

2. Negative Results Reported (total number) 

Negative (number) 

Negative-Dilute (number) 

3. Rejected for Testing Results Reported (total 

number) 

By Reason 

(a) Fatal flaw (number) 

(b) Uncorrected Flaw (number) 

4. Positive Results Reported (total number) 

By Drug 

(a) Marijuana Metabolite (number) 

(b) Cocaine Metabolite (number) 

(c) Opiates (number) 

(1) Codeine (number) 

(2) Morphine (number) 

(3) 6–AM (number) 

(d) Phencyclidine (number) 

(e) Amphetamines (number) 

(1) Amphetamine (number) 

(2) Methamphetamine (number) 

(3) MDMA (number) 

(4) MDA (number) 

(5) MDEA (number) 

5. Adulterated Results Reported (total 

number) 

By Reason (number) 

6. Substituted Results Reported (total 

number) 

7. Invalid Results Reported (total number) 

By Reason (number) 

[FR Doc. 2010–20095 Filed 8–13–10; 8:45 am] 

BILLING CODE 4910–9X–P 

WReier-Aviles on DSKGBLS3C1PROD with RULES