5722 Federal Register / Vol. 75, No. 23 / Thursday, February 4, 2010 / Proposed Rules 

52.203–12 [Amended] 

66. Amend section 52.203–12 by 

removing from the clause heading ‘‘(Sep 

2007)’’ and adding ‘‘(Date)’’ in its place; 

and removing from paragraphs (g)(1) 

and (g)(3) ‘‘$100,000’’ and adding 

‘‘$150,000’’ in its place. 

52.204–8 [Amended] 

67. Amend section 52.204–8 by 

removing from the provision heading 

‘‘(Feb 2009)’’ and adding ‘‘(Date)’’ in its 

place; and removing from paragraph 

(c)(1)(ii) ‘‘$100,000’’ and adding 

‘‘$150,000’’ in its place. 

52.212–3 [Amended] 

68. Amend section 52.212–3 by 

removing from the provision heading 

‘‘(Aug 2009)’’ and adding ‘‘(Date)’’ in its 

place; and removing from paragraph (e) 

‘‘$100,000’’ and adding ‘‘$150,000’’ in its 

place. 

52.212–5 [Amended] 

69. Amend section 52.212–5 by— 

a. Removing from the clause heading 

‘‘(Dec 2009)’’ and adding ‘‘(Date)’’ in its 

place; 

b. Removing from paragraph (b)(11)(i) 

‘‘(Apr 2008)’’ and adding ‘‘(Date)’’ in its 

place; 

c. Removing from paragraph (b)(24) 

‘‘(Jun 1998)’’ and adding ‘‘(Date)’’ in its 

place; 

d. Removing from paragraph (e)(1)(ii) 

‘‘$550,000’’ and adding ‘‘$650,000’’ in its 

place, and removing ‘‘$1,000,000’’ and 

adding ‘‘$1.5 million’’ in its place; 

e. Removing from paragraph (e)(1)(vi) 

‘‘(Jun 1998)’’ and adding ‘‘(Date)’’ in its 

place; and 

f. In Alternate II by— 

1. Removing from the Alternate 

heading ‘‘(Dec 2009)’’ and adding 

‘‘(Date)’’ in its place; 

2. Removing from paragraph 

(e)(1)(ii)(C) ‘‘$550,000’’ and adding 

‘‘$650,000’’ in its place, and removing 

‘‘$1,000,000’’ and adding ‘‘$1.5 million’’ 

in its place; and 

3. Removing from paragraph 

(e)(1)(ii)(F) ‘‘(June 1998)’’ and adding 

‘‘(Date)’’ in its place. 

52.213–4 [Amended] 

70. Amend section 52.213–4 by— 

a. Removing from the clause heading 

‘‘(Dec 2009)’’ and adding ‘‘(Date)’’ in its 

place; 

b. Removing from paragraph (a)(2)(vi) 

‘‘(Dec 2009)’’ and adding ‘‘(Date)’’ in its 

place; 

c. Removing from paragraph (b)(1)(ii) 

‘‘(Dec 1996)’’ and adding ‘‘(Date)’’ in its 

place, and removing ‘‘$10,000’’ and 

adding ‘‘$15,000’’ in its place; and 

d. Removing from paragraph (b)(1)(iv) 

‘‘(June 1998)’’ and adding ‘‘(Date)’’ in its 

place, and removing ‘‘$10,000’’ and 

adding ‘‘$15,000’’ in its place. 

52.219–9 [Amended] 

71. Amend section 52.219–9 by— 

a. Removing from the clause heading 

‘‘(Apr 2008)’’ and adding ‘‘(Date)’’ in its 

place; 

b. Removing from paragraph (d)(9) 

‘‘$550,000’’ and adding ‘‘$650,000’’ in its 

place, and removing ‘‘$1,000,000’’ and 

adding ‘‘$1.5 million’’ in its place; 

c. Removing from the introductory 

text of paragraph (d)(11)(iii) ‘‘$100,000’’ 

and adding ‘‘$150,000’’ in its place; and 

d. Removing from paragraph 

(l)(2)(i)(C) ‘‘$550,000’’ and adding 

‘‘$650,000’’ in its place, and removing 

‘‘$1,000,000’’ and adding ‘‘$1.5 million’’ 

in its place. 

52.222–20 [Amended] 

72. Amend section 52.222–20 by 

removing from the clause heading ‘‘(Dec 

1996)’’ and adding ‘‘(Date)’’ in its place; 

and removing from the introductory 

paragraph ‘‘$10,000’’ and adding 

‘‘$15,000’’ in its place. 

52.222–36 [Amended] 

73. Amend section 52.222–36 by 

removing from the clause heading ‘‘(Jun 

1998)’’ and adding ‘‘(Date)’’ in its place; 

and removing from paragraph (d) 

‘‘$10,000’’ and adding ‘‘$15,000’’ in its 

place. 

52.225–8 [Amended] 

74. Amend section 52.225–8 by 

removing from the clause heading ‘‘(Feb 

2000)’’ and adding ‘‘(Date)’’ in its place; 

and removing from the introductory 

texts of paragraphs (c)(1) and (j)(2) 

‘‘$10,000’’ and adding ‘‘$15,000’’ in its 

place. 

52.228–15 [Amended] 

75. Amend section 52.228–15 by 

removing from the clause heading ‘‘(Nov 

2006)’’ and adding ‘‘(Date)’’ in its place; 

and removing from the introductory text 

of paragraph (b) ‘‘$100,000’’ and adding 

‘‘$150,000’’ in its place. 

52.244–6 [Amended] 

76. Amend section 52.244–6 by— 

a. Removing from the clause heading 

‘‘(Dec 2009)’’ and adding ‘‘(Date)’’ in its 

place; 

b. Removing from paragraph (c)(1)(iii) 

‘‘$550,000’’ and adding ‘‘$650,000’’ in its 

place, and removing ‘‘$1,000,000’’ and 

adding ‘‘$1.5 million’’ in its place; and 

c. Removing from paragraph (c)(1)(vi) 

‘‘(Jun 1998)’’ and adding ‘‘(Date)’’ in its 

place. 

52.248–1 [Amended] 

77. Amend section 52.248–1 by 

removing from the clause heading ‘‘(Feb 

2000)’’ and adding ‘‘(Date)’’ in its place; 

and removing from paragraph (l) 

‘‘$100,000’’ and adding ‘‘$150,000’’ in its 

place. 

52.248–3 [Amended] 

78. Amend section 52.248–3 by 

removing from the clause heading ‘‘(Sep 

2006)’’ and adding ‘‘(Date)’’ in its place; 

and removing from paragraph (h) 

‘‘$55,000’’ and adding ‘‘$65,000’’ in its 

place. 

[FR Doc. 2010–2318 Filed 2–3–10; 8:45 am] 

BILLING CODE 6820–EP–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: Notice of proposed rulemaking. 

SUMMARY: The Department of 

Transportation is proposing to amend 

certain provisions of its drug testing 

procedures dealing with laboratory 

testing of urine specimens. Some of the 

proposed changes will also affect the 

roles and standards applying to 

collectors and Medical Review Officers. 

The proposed changes are intended to 

create consistency with new 

requirements established by the U.S. 

Department of Health and Human 

Services Mandatory Guidelines. 

DATES: Comments to the notice of 

proposed rulemaking should be 

submitted by April 5, 2010. Late-filed 

comments will be considered to the 

extent practicable. 

ADDRESSES: To ensure that you do not 

duplicate your docket submissions, 

please submit them by only one of the 

following means: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov and follow 

the online instructions for submitting 

comments. 

• Mail: Docket Management Facility, 

U.S. Department of Transportation, 1200 

New Jersey Ave., SE., West Building 

Ground Floor Room W12–140, 

Washington, DC 20590–0001; 

• Hand Delivery: West Building 

Ground Floor, Room W–12–140 1200 

New Jersey Ave., SE., between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. The telephone 

number is 202–366–9329; 


jlentini on DSKJ8SOYB1PROD with PROPOSALS
Federal Register / Vol. 75, No. 23 / Thursday, February 4, 2010 / Proposed Rules 5723 

Instructions: You must include the 

agency name and docket number DOT– 

OST—or the Regulatory Identification 

Number (RIN) for the rulemaking at the 

beginning of your comments. All 

comments received will be posted 

without change to http:// 

www.regulations.gov, including any 

personal information provided 

FOR FURTHER INFORMATION CONTACT: 

Mark Snider, Senior Policy Advisor (S– 

1), Office of Drug and Alcohol Policy 

and Compliance, 1200 New Jersey Ave., 

SE., Washington, DC 20590; telephone 

number 202–366–3784 (voice), 202– 

366–3897 (fax), or mark.snider@dot.gov 

(e-mail). 

SUPPLEMENTARY INFORMATION: 

Purpose 

In its final rule of December 2000 [65 

FR 79562, Dec. 19, 2000], the U.S. 

Department of Transportation (DOT) 

made significant changes to the drug 

testing rules to include making 

specimen validity testing (SVT) 

mandatory for the transportation 

industry contingent upon U.S. 

Department of Health and Human 

Services (HHS) publishing its 

Mandatory Guidelines on SVT. In late 

2001, the DOT amended part 40 [66 FR 

41944, Aug. 9, 2001] to remove the 

mandatory requirement because HHS 

had not finalized its Mandatory 

Guidelines regarding SVT. We said that 

SVT would remain authorized but not 

required. 

On April 13, 2004, HHS published a 

Federal Register notice revising its 

Mandatory Guidelines [69 FR 19644] 

with an effective date of November 1, 

2004. Among the revisions contained in 

the HHS Mandatory Guidelines were the 

requirements that laboratories modify 

substituted specimen and diluted 

specimen testing and reporting criteria. 

HHS revised laboratory requirements for 

adulterated specimen testing. HHS also 

required each Federal agency to conduct 

SVT to determine if urine specimens 

collected under HHS Federal Workplace 

Drug Testing Programs have been 

adulterated or substituted. 

In an interim final rule (IFR) [69 FR 

64865, Nov. 9, 2004], the DOT changed 

a number of items in its regulation to 

make part 40 and the HHS Mandatory 

Guidelines consistent. We did this to 

avoid conflicting requirements that 

implementation of both rules would 

have had on laboratories and Medical 

Review Officers (MROs). 

In the 2004 IFR, we indicated that we 

intended to fully address all aspects of 

the HHS changes to their Mandatory 

Guidelines in a future DOT notice of 

proposed rulemaking (NPRM). In an 

NPRM [70 FR 62276, Oct. 31, 2005], the 

DOT sought comments to include SVT 

mandatory for the transportation 

industry, and the instructions that were 

given to MROs, laboratories, and 

employers with respect to adulterated, 

substituted, diluted, and invalid drug 

testing results. In a final rulemaking [73 

FR 35961, Jun. 25, 2008] the DOT 

finalized these requirements to include 

making SVT mandatory for the 

transportation industry. 

On November 25, 2008, HHS issued a 

Notice of Revisions to the Mandatory 

Guidelines for Federal Workplace Drug 

Testing Programs (Revisions to 

Mandatory Guidelines) [73 FR 71858, 

Nov 28, 2008]. The HHS revised some 

of their requirements for collecting and 

testing urine specimens, initiated 

requirements for the certification of 

Instrumented Initial Test Facilities 

(IITFs), and expanded upon the roles of 

and standards for collectors and MROs. 

We are issuing this notice of proposed 

rulemaking to offer changes to 49 CFR 

Part 40 in an effort to create consistency 

with this latest set of requirements 

established by HHS. 

Principal Policy Issues 

Harmonization With HHS 

In this NPRM we are seeking to 

harmonize our proposals for 

laboratories, collectors, MROs, and 

employers with the new requirements 

contained in the revised HHS 

Mandatory Guidelines. Here are the 

most noteworthy of the coordinated 

proposals: 

1. We propose to modify some of our 

definitions and add a few new 

definitions in order to make them 

consistent with the HHS Mandatory 

Guidelines definitions. 

2. We propose to allow DOT 

employers to choose between a full 

service laboratory and an IITF. An IITF 

would only be able to provide results to 

employers for negative and negative 

dilute specimens, as well as specimens 

they reject for testing. All other 

specimens would be forwarded to an 

HHS certified laboratory. 

3. We propose to modify regulations 

to add IITFs to the laboratory section of 

this regulation and spell-out how an 

IITF should perform urine testing. An 

ITTF could conduct Initial Tests and 

SVT for all DOT employer programs. 

When an IITF discovers a non-negative 

drug test result, it will have to forward 

that result to a full service laboratory to 

perform a full analysis of the specimen 

and report the results to the employer’s 

MRO. 

4. The DOT is also proposing to adopt 

the following HHS laboratory testing 

requirements: 

• Conduct Initial Testing for 

Methylenedioxymethamphetamine 

(MDMA); 

• Conduct Confirmatory Testing for 

MDMA, Methylenedioxyamphetamine 

(MDA), and 

Methylenedioxyethylamphetamine 

(MDEA); 

• Conduct Initial Testing for 6– 

Acetylmorphines. 

• Lower the Initial Test and 

Confirmatory Test cutoff concentrations 

for Amphetamines; and 

• Lower the Initial Test and 

Confirmatory Test cutoff concentrations 

for Cocaine. 

We would note here that 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. Also, DOT is 

required by the Omnibus Transportation 

Employee Testing Act of 1991 to adhere 

with the HHS on these important 

laboratory testing matters. 

5. We are also proposing to amend 

Appendix B so that IITFs will be 

required to report semi-annual test 

reports to employers, as appropriate. 

Appendix C would also be modified to 

require IITFs to report semi-annual test 

data to the DOT. 

6. Finally, the HHS Mandatory 

Guidelines will require that nationallyrecognized 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 DOT is seeking comment on 

whether part 40 should require these 

groups to be approved. Would the DOT 

program be better served if we sought a 

shared approval process with the HHS? 

In addition, the DOT is seeking 

comments on whether part 40, at 49 

CFR Part 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 recertified 

every five years by an MRO certification 

board or subspecialty board. We believe 

this is a cost neutral proposition, and 

may even prove less costly because 

many MROs obtain both the 12 CEUs 

every 3 years and the MRO 

recertification every 5 years. 

While we have sought to harmonize 

our proposed regulations with the new 


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5724 Federal Register / Vol. 75, No. 23 / Thursday, February 4, 2010 / Proposed Rules 

HHS requirements, there remain some 

for which we have not proposed 

changes to some of our longstanding 

procedures. For items left unchanged in 

the HHS Guidelines from previous 

iterations, we believe there is no need 

to address them again. We have found 

that our procedures have worked well 

within and for the transportation 

industries. In addition, we must 

consider program costs and the value 

added in adopting some of the new HHS 

Mandatory Guidelines procedures. 

For example, the DOT does not 

propose to require observers to receive 

advanced formalized training to learn 

about the steps necessary to perform a 

direct observation collection (DO 

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 DO collection is very 

appropriate and has been for years. That 

way, the Department can be assured that 

the requisite instructions are provided 

each time that a DO collection 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) do 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 of the DO 

collection. The DOT is not aware of any 

cases where it was not effective to have 

the qualified and trained collector 

instruct the observer at the time the DO 

collection is to occur, and to do so each 

time a DO collection is required. 

Also, the DOT does not propose to 

change our longstanding regulatory 

position that a collector need not obtain 

prior approval from collection site 

supervisor before performing a DO 

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 

unnecessarily the DO process. We 

believe the collectors should continue to 

make these DO collection decisions and 

to continue basing those decision upon 

the clear requirements set forth in part 

40. 

Also, we will not propose to change 

the duration of the paperwork retention 

requirement for collectors. HHS will 

require collectors to keep Copy 3 for two 

years. The DOT believes the current 30 

days is sufficient in the DOT program. 

Retention for 30 days has proven a 

sufficient amount of time in which 

ensure that a CCF copy with the 

employee’s signature would be available 

to the MRO’s CCF copy were not 

available. Requiring document retention 

for three 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 5 percent or a 

maximum of 50 of their collection sites. 

DOT believes that creating a parallel 

requirement for transportation industry 

employers would be very expensive to 

employers in the DOT program in terms 

of time and resources, with few 

efficiency and/or safety benefits. The 

DOT would anticipate seeing more 

effective monitoring by the collection 

site parent organizations in an effort to 

ensure employers that sites under their 

organization umbrellas, with which 

employers are contracting, are properly 

conducting collections. The DOT 

Agencies and United States Coast Guard 

also provide on-site audits and 

inspections of collection sites. They 

have also increased their efforts to 

include mock collections and more 

clandestine inspections. All of these 

provide added oversight to determine 

whether collection site personnel are 

properly performing collections and 

whether collection sites adhere to the 

DOT’s security and integrity 

requirements. 

The revised HHS Mandatory 

Guidelines will require at least 3 

percent blind specimen testing, 

compared to DOT’s current 1 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 via the DOT requirements are 

quite ample. 

The new HHS Mandatory Guidelines 

require MROs to retain records for two 

years. The current DOT regulations 

currently require that MROs to follow 

the employer’s recordkeeping 

requirements, one year for negative 

results and 5 years for non-negative 

results. The DOT is comfortable with 

the existing provision, but seeks 

comments about what types of MRO 

records should be covered under the 

record keeping requirements. Is it 

normal practice for an MRO to include 

in his or her paperwork personal notes 

and conversations with laboratory 

personnel? What other types of records 

would MROs normally be required to 

keep as part of this paperwork 

requirement? The DOT would like for 

MROs to provide comment upon what 

they believe are records DOT inspectors 

or auditors could expect to see when 

reviewing MROs records as part of the 

overall compliance audit of a DOTregulated employer. 

In addition, we propose to limit IITF 

and MRO relationships similar to the 

limits placed upon laboratory and MRO 

relationships. We are also proposing 

that MROs treat MDMA positives like 

any other Schedule I drug for which we 

test: MROs must not accept an assertion 

that there is a legitimate medical 

explanation for the presence of MDMA 

in a specimen. 

Section-by-Section NPRM Issues 

1. Index Changes—We would modify 

some existing section headings and add 

new section headings in order to reflect 

regulation text changes. All told, 39 

sections of our regulation are proposed 

to be modified or added. 

2. Definition changes—In order to 

align our definitions section (§ 40.3) 

more closely with definitions contained 

in the HHS Mandatory Guidelines, we 

propose to modify some of our existing 

definitions and add some new ones. We 

revised the definitions of ‘‘adulterated 

specimen,’’ ‘‘blind specimen or blind 

performance test specimen,’’ ‘‘cancelled 

test,’’ ‘‘confirmatory drug test,’’ 

‘‘confirmatory validity test,’’ ‘‘initial drug 

test (also known as a screening drug 

test,’’ ‘‘invalid result,’’ ‘‘laboratory,’’ 

‘‘limit of detection (LOD),’’ ‘‘performance 

testing (PT) sample,’’ ‘‘primary 

specimen,’’ and ‘‘split specimen.’’ We 

also added several new definitions. 

3. Appendix Items—At Appendix B, 

we propose to modify the semi-annual 

laboratory report to employers so that it 

will have the same information required 

by the HHS Mandatory Guidelines. The 

report will also require laboratories to 

report the number of positive results for 

MDMA. We also provide additional 

clarification to IITFs about what data 

they should report and how they are to 

report it to employers. The proposed 

changes, while not dramatic, will help 

laboratories and IITFs avoid needing 


jlentini on DSKJ8SOYB1PROD with PROPOSALS
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two different report formats, one for 

DOT and one for HHS. 

At Appendix C, we provide 

clarification to IITFs about what data 

they should report and how they are to 

report it to the DOT on a semi-annual 

basis. 

Other Issues 

The Department is aware that HHS is 

preparing an NPRM which will propose 

changes to the current Federal Drug 

Testing Custody and Control Form 

(CCF). If changes are adopted by HHS, 

they would likely have some impact 

upon the DOT procedural requirements 

for collectors, laboratories, and MRO’s. 

When the HHS rule on the revised CCF 

is published, the Department will make 

necessary changes to part 40. 

Some individuals have recently raised 

issues about screening and confirmation 

of 6–AM at 10 ng/mL without the need 

show the presence of morphine in the 

specimen. If there are factual, evidencebased concerns, we would like to hear 

them. If there are such valid concerns, 

are there viable laboratory testing 

resolutions to the issue? Or must the 

regulation provide additional 

instruction to MROs about how to deal 

with a positive heroin result? What 

would that instruction be? 

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 

Department of Transportation Act (49 

U.S.C. 322). 

This rule is not significant for 

purposes of Executive Order 12866 or 

the DOT’s regulatory policies and 

procedures. It proposes modifications to 

our overall part 40 procedures and is 

intended only to further align our 

laboratory procedures and processes, as 

well as a few collection and MRO 

procedures, with those requirements 

that are being directed by the HHS 

Guidelines which were considered nonsignificant. Their economic effects will 

be negligible for DOT regulated 

employers. Consequently, the DOT 

certifies, under the Regulatory 

Flexibility Act, this rule will not have 

a significant economic impact on a 

substantial number of small entities. 

We would note that all HHS-certified 

laboratories must have the capability to 

accurately test for MDMA in order to 

pass certification requirements of the 

National Laboratory Certification 

Program. In addition, Federal Agency 

employee testing programs will have to 

test for MDMA, as well as amphetamine 

and cocaine at the new cutoffs. Our 

harmonizing on these matters will only 

bring clarity and consistency to the 

efforts of the Federal testing programs, 

programs that are internal to the Federal 

Government and those that are regulated 

by the Federal Government. 

HHS has estimated that there may be 

10% more users of amphetamine and 

cocaine identified using the lowered 

cutoffs and testing for new drugs. HHS 

says the incidence and prevalence of 

amphetamines and cocaine use is very 

low. Our data supports this fact. From 

July 1, 2008 through June 30, 2009, the 

DOT’s regulated-transportation industry 

program had 14,440 amphetamine 

positive and 15,675 cocaine positive 

laboratory results in the 5,444,255 total 

test results reported. These relatively 

small numbers mean that MRO review 

costs and burdens resulting from 

additional requirements in the proposed 

rule should be minimal. 

In the DOT-regulated industries, more 

positive results should not impose a 

significant economic impact or burdens 

on testing laboratories. The Department 

has obtained information on costs for 

MDMA and 6–AM testing at 11 

laboratories representing about 3.6 

million DOT tests, approximately 67 

percent of the 5,444,255 tests mentioned 

above for the July 2008—June 2009 

period. Because the cost per test varies 

among laboratories (from a low of $0.06 

per MDMA or 6–AM test to a high of 

$1.27 per test for MDMA tests and $2.27 

per test for 6–AM tests), appearing to 

depend in part on the volume of tests at 

each laboratory, the Department 

calculated a weighted average cost per 

test for the industry. Given the number 

of tests conducted by each laboratory, 

MDMA tests would have cost a 

weighted average of $0.09 per test; 6– 

AM tests would have a weighted 

average cost of $0.26 per test. The actual 

dollar cost of the tests at the 11 

laboratories would have been $392,125 

for MDMA, $569,024 for 6–AM, and 

$961,419 combined. Extrapolating the 

weighted average costs per test to the 

100 percent of the DOT tests would 

result in an estimated cost of $489,982 

for MDMA tests, $871,081 for 6–AM 

tests, and $1,361,063 combined. 

We have concluded that this rule is 

not significant for purposes of Executive 

Order 12866 or the DOT’s regulatory 

policies and procedures. In addition to 

its low costs, it proposes modifications 

to our overall part 40 procedures and is 

intended only 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 non-significant rules. 

List of Subjects in 49 CFR Part 40 

Administrative practice and 

procedures, Alcohol abuse, Alcohol 

testing, Drug abuse, Drug testing, 

Laboratories, Reporting and 

recordkeeping requirements, Safety, 

Transportation. 

Issued this 20th day of January 2010 at 

Washington, DC. 

Ray LaHood, 

Secretary of Transportation. 

For reasons discussed in the 

preamble, the Department of 

Transportation proposes to amend part 

40 of Title 49 Code of Federal 

Regulations, 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. Section 40.3 is amended as follows: 

A. Revise the definitions of 

Adulterated specimen, Blind Specimen 

or blind performance test specimen, 

Cancelled test, Confirmatory drug test, 

Initial drug test, Invalid result, 

Laboratory, and Limit of Detection. 

B. Add definitions of Alternate 

Responsible Technician, Certifying 

Scientist (CS), Certifying Technician 

(CT), Instrumented Initial Test Facility 

(IITF), Limit of Quantitation, Negative 

result, Positive result, Reconfirmed, 

Rejected for testing, Responsible Person 

(RP), Responsible Technician (RT), and 

Split specimen collection in 

alphabetical order. 

The revisions and additions read as 

follows: 

§ 40.3 What do the terms used in this 

regulation 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. 

* * * * * 

Alternate Responsible Technician. 

The person who assumes professional, 

organizational, educational, and 

administrative responsibility for the 

day-to-day management of the HHScertified IITF when the responsible 


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technician is unable to fill these 

obligations. 

* * * * * 

Blind Specimen or blind performance 

test specimen. A specimen submitted to 

an HHS-certified laboratory or an HHScertified IITF for quality control testing 

purposes, with a fictitious identifier, so 

that the laboratory or IITF cannot 

distinguish it from an employee 

specimen. 

* * * * * 

Cancelled test. The result reported by 

the MRO to the employer when a 

specimen has been reported to the MRO 

as invalid result (and the donor has no 

legitimate explanation) or rejected for 

testing, when a split specimen fails to 

reconfirm, or when the MRO determines 

that a fatal flaw or unrecovered 

correctable error exists in the forensic 

records. 

Certifying Scientist (CS). The 

individual responsible for verifying the 

chain of custody and scientific 

reliability of any test result reported by 

an HHS-certified laboratory. 

Certifying Technician (CT). The 

individual responsible for verifying the 

chain of custody and scientific 

reliability of negative, negative/dilute, 

and rejected for testing results reported 

by a laboratory or IITF. 

* * * * * 

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. The test used to 

differentiate a negative specimen from 

one that requires further testing for 

drugs or drug metabolites. 

* * * * * 

Instrumented Initial Test Facility 

(IITF). A permanent location where 

initial testing, reporting of results, and 

recordkeeping are performed under the 

supervision of a responsible technician. 

Any U.S. IITF certified by HHS under 

the National Laboratory Certification 

Program as meeting the IITF minimum 

standards of Subpart I of the HHS 

Mandatory Guidelines for Federal 

Workplace Drug Testing Programs; or, in 

the case of foreign laboratories, an IITF 

approved for participation by DOT 

under this part. (The HHS Mandatory 

Guidelines for Federal Workplace Drug 

Testing Programs are available on the 

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

workpl.htm or from the Division of 

Workplace Programs, 1 Choke Cherry 

Road, Room 2–1035, Rockville, MD 

20857). 

* * * * * 

Invalid result. The result reported by 

an HHS-certified laboratory in 

accordance with the criteria established 

in HHS Guidelines when a positive, 

negative, adulterated, or substituted 

result cannot be established for a 

specific drug or specimen validity test. 

Laboratory. A permanent location 

where initial and confirmatory testing, 

reporting of results, and recordkeeping 

is performed under the supervision of a 

responsible person. Any U.S. laboratory 

certified by HHS under the National 

Laboratory Certification Program as 

meeting the laboratory minimum 

standards of Subpart I 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. 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 or an HHScertified IITF to an MRO when a 

specimen contains no drug or the 

concentration of the drug is less than 

the cutoff concentration for that 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 concentration. 

* * * * * 

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 

or HHS-certified IITF when no tests are 

performed for a specimen because of a 

fatal flaw or a correctable flaw that is 

not corrected. 

Responsible Person (RP). The person 

who assumes professional, 

organizational, educational, and 

administrative responsibility for the 

day-to-day management of the HHScertified laboratory. 

Responsible Technician (RT). The 

person who assumes professional, 

organizational, educational, and 

administrative responsibility for the 

day-to-day management of the HHScertified IITF. 

* * * * * 

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 § 40.13, paragraph (c) is revised, 

to read as follows: 

§ 40.13 How do DOT drug and alcohol 

tests relate to non-DOT tests? 

* * * * * 

(c) Except as provided in paragraph 

(d) of this section, you must not perform 

any tests on DOT urine or breath 

specimens other than those specifically 

authorized by this part or DOT agency 

regulations. For example, you must not 

test a DOT urine specimen for 

additional drugs; and a laboratory or 

IITF is prohibited from making a DOT 

urine specimen available for a DNA test 

or other types of specimen identity 

testing. 

* * * * * 

4. Section 40.27 is revised, to read as 

follows: 

§ 40.27 May an employer require an 

employee to sign a consent or release in 

connection with the DOT drug and alcohol 

testing program? 

No, as an employer, you must not 

require an employee to sign a consent, 

release, waiver of liability, or 

indemnification agreement with respect 

to any part of the drug or alcohol testing 

process covered by this part (including, 

but not limited to, collections, 

laboratory or IITF testing, MRO and SAP 

services). 

5. In § 40. 41, paragraph (c) is revised, 

to read as follows: 

§ 40.41 Where does a urine collection for 

a DOT drug test take place? 

* * * * * 

(c) If you are operating a collection 

site, you must have all necessary 

personnel, materials, equipment, 

facilities and supervision to provide for 

the collection, temporary storage, and 

shipping of urine specimens to a 

laboratory or IITF, and a suitable clean 

surface for writing. 

* * * * * 

6. In § 40.45, paragraphs (b) and (d) 

are revised, to read as follows: 

§ 40.45 What form is used to document a 

DOT urine collection? 

* * * * * 

(b) You must not use a non-Federal 

form or an expired Federal form to 


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conduct a DOT urine collection. As a 

laboratory or IITF, C/TPA or other party 

that provides CCFs to employers, 

collection sites, or other customers, you 

must not provide copies of an expired 

Federal form to these participants. You 

must also notify these participants that 

they must not use an expired Federal 

form. 

* * * * * 

(d) Under no circumstances may the 

CCF transmit personal identifying 

information about an employee (other 

than a social security number (SSN) or 

other employee identification (ID 

number)) to a laboratory or IITF. 

* * * * * 

7. Section 40.51 is revised, to read as 

follows: 

§ 40.51 What materials are used to send 

urine specimens to the laboratory or IITF? 

(a) Except as provided in paragraph 

(b) of this section, you must use a 

shipping container that adequately 

protects the specimen bottles from 

shipment damage in the transport of 

specimens from the collection site to the 

laboratory or IITF. 

(b) You are not required to use a 

shipping container if a laboratory or 

IITF courier hand-delivers the 

specimens from the collection site to the 

laboratory or IITF. 

8. In § 40.73, paragraphs (a)(2), 

(a)(8)(iii), and (b) are revised, to read as 

follows: 

§ 40.73 How is the collection process 

completed? 

(a) * * * 

(2) Complete the chain of custody on 

the CCF (Step 4) by printing your name 

(Note: You may pre-print your name), 

recording the time and date of the 

collection, signing the statement, and 

entering the name of the delivery 

service transferring the specimen to the 

laboratory or IITF, 

(8) * * * 

(iii) If a laboratory or IITF courier 

hand-delivers the specimens from the 

collection site to the laboratory or IITF, 

prepare the sealed plastic bag for 

shipment as directed by the courier 

service. 

* * * * * 

(b) As a collector or collection site, 

you must ensure that each specimen 

you collect is shipped to a laboratory or 

IITF as quickly as possible, but in any 

case within 24 hours or during the next 

business day. 

9. In § 40.81, the section heading and 

paragraphs (b) through (d) are revised, 

and paragraphs (e) and (f) are added, to 

read as follows: 

§ 40.81 What laboratories or IITFs may be 

used for DOT drug testing? 

* * * * * 

(b) As an IITF located in the U.S., you 

are permitted to participate in DOT drug 

testing only if you are certified by HHS 

under the NLCP for initial testing 

required under this part. 

(c) As a drug testing laboratory 

located in Canada or Mexico which is 

not certified by HHS under the NLCP, 

you are permitted to participate in DOT 

drug testing only if: 

(1) The DOT, based on a written 

recommendation from HHS, has 

approved your laboratory as meeting 

HHS laboratory verification standards, 

or deemed your laboratory or IITF fully 

equivalent to a laboratory meeting HHS 

laboratory certification standards for 

testing required under this part; or 

(2) The DOT, based on a written 

recommendation from HHS, has 

recognized a Canadian or Mexican 

certifying organization as having 

equivalent laboratory certification 

standards and procedures to those of 

HHS, and the Canadian or Mexican 

certifying organization has certified 

your laboratory under those equivalent 

standards and procedures. 

(d) As an IITF located in Canada or 

Mexico which is not certified by HHS 

under the NLCP, you are permitted to 

participate in DOT drug testing only if: 

(1) The DOT, based on a written 

recommendation from HHS, has 

approved your IITF as meeting HHS 

laboratory verification standards, or 

deemed your laboratory or IITF fully 

equivalent to a laboratory meeting HHS 

laboratory certification standards for 

testing required under this part; or 

(2) The DOT, based on a written 

recommendation from HHS, has 

recognized a Canadian or Mexican 

certifying organization as having 

equivalent IITF certification standards 

and procedures to those of HHS, and the 

Canadian or Mexican certifying 

organization has certified your IITF 

under those equivalent standards and 

procedures. 

(e) As a laboratory or IITF 

participating in the DOT drug testing 

program, you must comply with the 

requirements of this part. You must also 

comply with all applicable requirements 

of HHS in testing DOT specimens, 

whether or not the HHS requirements 

are explicitly stated in this part. 

(f) If DOT determines that you are in 

noncompliance with this part, you 

could be subject to PIE proceedings 

under Subpart R of this part. If the 

Department issues a PIE with respect to 

you, you are ineligible to participate in 

the DOT drug testing program even if 

you continue to meet the requirements 

of paragraph (a), (b), (c), or (d) of this 

section. 

10. In § 40.83, the section heading, the 

introductory text, and paragraphs 

(h)(1)(i), (h)(1)(iii), (h)(1)(iv), (h)(2), and 

(i) are revised, to read as follows: 

§ 40.83 How do laboratories or IITFs 

process incoming specimens? 

As the laboratory or IITF, you must do 

the following when you receive a DOT 

specimen from a collection site: 

(a) You are authorized to receive only 

copy (1) of the CCF. You are not 

authorized to receive other copies of the 

CCF nor any copies of the alcohol 

testing form. 

* * * * * 

(h) * * * 

(1) * * * 

(i) The primary specimen appears to 

have leaked out of its sealed bottle and 

the laboratory believes a sufficient 

amount of urine exists in the split 

specimen to conduct all appropriate 

primary laboratory or IITF testing; or 

(ii) * * * 

(iii) The laboratory or IITF opens the 

split specimen instead of the primary 

specimen, the primary specimen 

remains sealed, and the laboratory or 

IITF believes a sufficient amount of 

urine exists in the split specimen to 

conduct all appropriate primary 

laboratory or IITF testing; or 

(iv) The primary specimen seal is 

broken but the split specimen remains 

sealed and the laboratory or IITF 

believes a sufficient amount of urine 

exists in the split specimen to conduct 

all appropriate primary laboratory 

testing. 

(2) In situations outlined in paragraph 

(h)(1) of this section, the laboratory or 

IITF shall mark through the ‘‘A’’ and 

write ‘‘B,’’ then initial and date the 

change. A corresponding change shall 

be made to the other bottle by marking 

through the ‘‘B’’ and writing ‘‘A,’’ and 

initialing and dating the change. 

(i) A notation shall be made on Copy 

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

laboratory or IITF internal chain of 

custody documents, as appropriate, for 

any fatal or correctable flaw. 

11. A new § 40.84 is added, to read as 

follows: 

§ 40.84 How do laboratories process and 

test specimens received from an IITF? 

(a) As a laboratory, you must process 

each specimen received from an IITF 

you must do so following the 

appropriate procedures outlined in the 

HHS Mandatory Guidelines. 

(b) You must test each specimen 

received from an IITF in the same 

manner as if it had not been previously 

tested. 


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12. Section 40.85 is revised, to read as 

follows: 

§ 40.85 For what drugs do laboratories or 

IITFs test? 

As a laboratory or IITF, you must test 

for the following five drugs or classes of 

drugs in a DOT drug test. You must not 

test ‘‘DOT specimens’’ for any other 

drugs. 

(a) Marijuana metabolites. 

(b) Cocaine metabolites. 

(c) Amphetamines. 

(d) Opiate metabolites. 

(e) Phencyclidine (PCP). 

13. Section 40.87 is revised, to read as 

follows: 

§ 40.87 What are the cutoff concentrations 

for initial and confirmation tests? 

(a) As a laboratory, you must use the 

Initial Test and Confirmatory Test cutoff 

concentrations displayed in the 

following table. As an IITF, you must 

use the Initial Test cutoff concentrations 

displayed in the following table. 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/Morphine 2 .......................... 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. 

Amphetamines: 3

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

Methamphetamine 5 ............................... 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). 

(b) As a laboratory or IITF, on an 

initial drug test you must report a result 

below the cutoff concentration as 

negative. 

(c) If the result is at or above the cutoff 

concentration: 

(1) As a laboratory, you must conduct 

a confirmation test. 

(2) As an IITF, you must forward the 

specimen and its split to an HHScertified laboratory; and you must do so 

following the appropriate procedures 

outlined in the HHS Mandatory 

Guidelines. 

(d) As a laboratory, on a confirmation 

drug test you must report a result below 

the cutoff concentration as negative and 

a result at or above the cutoff 

concentration as confirmed positive. 

(e) As a laboratory, you must report 

quantitative values for morphine or 

codeine at 15,000 ng/mL or above. 

14. In § 40.89, the section heading and 

paragraph (b) are revised, to read as 

follows: 

§ 40.89 What is validity testing, and are 

laboratories or IITFs required to conduct it? 

* * * * * 

(b) As a laboratory or IITF you must 

conduct validity testing. 

15. Section 40.91 is revised to read as 

follows: 

§ 40.91 What validity tests must 

laboratories and IITFs conduct on primary 

specimens? 

As a laboratory or IITF, when you 

conduct validity testing under § 40.89, 

you must conduct it in accordance with 

the requirements of this section; and 

you must ensure that the following 

specimen validity tests are conducted 

on each specimen: 

(a) You must determine the creatinine 

concentration on every specimen; 

(b) You must determine the specific 

gravity on every specimen for which the 

creatinine concentration is less than 20 

mg/dL; 

(c) You must determine the pH on 

every specimen; and 

(d) You must perform one or more 

specimen validity tests for oxidizing 

adulterants on every specimen. 

(e) If a specimen exhibits abnormal 

physical characteristics (e.g., unusual 

odor or color, semi-solid 

characteristics), causes reactions or 

responses characteristic of an adulterant 

during initial or confirmatory drug tests 

(e.g., non-recovery of standards, unusual 

response), or contains an unidentified 

substance that interferes with the 

confirmatory analysis, then additional 

testing may be performed. 

(f) As a laboratory, if you determine 

that the specimen is invalid and HHS 

Guidelines direct you to contact the 

MRO, you must contact the MRO and 

together decide if testing the primary 

specimen by another HHS certified 

laboratory would be useful in being able 

to report a positive or adulterated test 

result. 

(g) As an IITF, if you determine that 

a specimen is adulterated, substituted, 

or invalid you must forward that 

specimen and its split to a HHS certified 

laboratory. 

16. A new § 40.92 is added to read as 

follows: 

§ 40.92 What specimen validity test criteria 

must be met in order for an IITF to send 

specimens to an HHS-certified laboratory? 

(a) As an IITF, you must forward 

specimens to an HHS-certified 

laboratory when the creatinine test 

result is equal to or less than 5.0 mg/dL 

or when the screening specific gravity 

test result is less than 1.002. 

(b) As an IITF, you must forward 

specimens to an HHS-certified 


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laboratory when the pH is less than 4.5 

or equal to or greater than 9.0. 

(c) As an IITF, your must forward 

specimens to an HHS-certified 

laboratory when the nitrite 

concentration is equal to or greater than 

200 mcg/mL must be forwarded to an 

HHS-certified laboratory. 

(d) As an IITF, you must forward 

specimens to an HHS-certified 

laboratory if the oxidizing adulterant 

result is equal to or greater than the 

cutoff. 

(e) As an IITF, you must forward 

specimens to an HHS-certified 

laboratory in accordance with the 

invalid test result criteria required by 

the HHS Guidelines. 

17. A new § 40.98 is added to read as 

follows: 

§ 40.98 What do IITFs report and how do 

they report it? 

(a) As an IITF, you may only report 

negative results and rejected for testing 

results. 

(b) When a specimen is found to be 

negative, you must report the test result 

as being one of the following: 

(1) Negative, or 

(2) Negative-dilute, with numerical 

values for creatinine and specific 

gravity. The creatinine values must be 

greater than 5 mg/dL but less than 20 

mg/dL; and the specific gravity values 

must be equal to or greater than 1.002 

but less than 1.003. 

(c) As an IITF, you must report the 

results directly, and only, to the MRO at 

his or her place of business. You must 

not report results to or through the DER 

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

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

electronically transmit a legible image 

or copy of the fully-completed Copy 1 

of the CCF which has been signed by the 

certifying technician, or you may 

provide the IITF results report 

electronically (i.e., computer data file). 

(i) If you elect to provide 

electronically the IITF results report, 

you must include the following 

elements, as a minimum, in the report 

format: 

(A) IITF name and address; 

(B) Employer’s name (you may 

include I.D. or account number); 

(C) Medical review officer’s name; 

(D) Specimen I.D. number; 

(E) Donor’s SSN or employee I.D. 

number, if provided; 

(F) Reason for test, if provided; 

(G) Collector’s name and telephone 

number; 

(H) Date of the collection; 

(I) Date received at the IITF; 

(J) Certifying Technician’s name; 

(K) Date Certifying Technician 

released the results; 

(L) Results (i.e., Negative, NegativeDilute (with values for creatinine and 

specific gravity), or Rejected for Testing 

(with reason). 

(ii) [Reserved] 

(2) [Reserved] 

(d) As an IITF, any primary specimen 

that tested positive, adulterated, 

substituted, or invalid you must forward 

the remaining specimen and split 

specimen to a HHS certified laboratory, 

following the procedures outlined in the 

HHS Mandatory Guidelines. 

18. A new § 40.100 is added to read 

as follows 

§ 40.100 How long must an IITF retain a 

specimen? 

A specimen that is negative, negativedilute, or rejected for testing is 

discarded. 

19. Section 40.101 is revised, to read 

as follows: 

§ 40.101 What relationship may a 

laboratory or IITF have with an MRO? 

(a) As a laboratory or IITF, you must 

not enter into any relationship with an 

MRO that creates a conflict of interest or 

the appearance of a conflict of interest 

with the MRO’s responsibilities for the 

employer. You must not derive any 

financial benefit by having an employer 

use a specific MRO. 

(b) The following are examples of 

relationships between laboratories or 

IITFs and MROs that the Department 

regards as creating conflicts of interest, 

or the appearance of such conflicts. This 

following list of examples is not 

intended to be exclusive or exhaustive: 

(1) The laboratory or IITF employs an 

MRO who reviews test results produced 

by the laboratory or IITF; 

(2) The laboratory or IITF has a 

contract or retainer with the MRO for 

the review of test results produced by 

the laboratory or IITF; 

(3) The laboratory or IITF designates 

which MRO the employer is to use, 

gives the employer a slate of MROs from 

which to choose, or recommends certain 

MROs; 

(4) The laboratory or ITTF gives the 

employer a discount or other incentive 

to use a particular MRO; 

(5) The laboratory or IITF has its place 

of business co-located with that of an 

MRO or MRO staff who review test 

results produced by the laboratory or 

IITF; or 

(6) The laboratory or IITF permits an 

MRO, or an MRO’s organization, to have 

a financial interest in the laboratory or 

IITF. 

20. In § 40.103, the section heading, 

paragraphs (a) and (b), paragraph (c) 

introductory text, paragraph (d) 

introductory text, and paragraph (d)(1) 

are revised, to read as follows: 

§ 40.103 What are the requirements for 

submitting blind specimens to a laboratory 

or IITF? 

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

aggregate of 2000 or more DOT-covered 

employees, you must send blind 

specimens to laboratories or IITFs you 

use. If you have an aggregate of fewer 

than 2000 DOT-covered employees, you 

are not required to provide blind 

specimens. 

(b) To each laboratory or IITF to 

which you send at least 100 specimens 

in a year, you must transmit a number 

of blind specimen’s equivalent to one 

percent of the specimens you send to 

that laboratory or IITF, up to a 

maximum of 50 blind specimens in each 

quarter (i.e., January–March, April– 

June, July–September, October– 

December). As a C/TPA, you must apply 

this percentage to the total number of 

DOT-covered employees’ specimens you 

send to the laboratory or IITF. Your 

blind specimen submissions must be 

evenly spread throughout the year. The 

following examples illustrate how this 

requirement works: 

Example 1 to Paragraph (b). You send 2500 

specimens to Lab or IITF X in Year 1. In this 

case, you would send 25 blind specimens to 

Lab or IITF X in Year 1. To meet the even 

distribution requirement, you would send 6 

in each of three quarters and 7 in the other. 

Example 2 to Paragraph (b). You send 2000 

specimens to Lab or IITF X and 1000 

specimens to Lab or IITF Y in Year 1. In this 

case, you would send 20 blind specimens to 

Lab or IITF X and 10 to Lab or IITF Y in Year 

1. The even distribution requirement would 

apply in a similar way to that described in 

Example 1. 

Example 3 to Paragraph (b). Same as 

Example 2, except that you also send 20 

specimens to Lab or IITF Z. In this case, you 

would send blind specimens to Labs or IITFs 

X and Y as in Example 2. You would not 

have to send any blind specimens to Lab or 

IITF Z, because you sent fewer than 100 

specimens to Lab or IITF Z. 

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

TPA sending 2000 specimens to Lab or IITF 

X in Year 1. These 2000 specimens represent 

200 small employers who have an average of 

10 covered employees each. In this case 

you—not the individual employers—send 20 

blind specimens to Lab or IITF X in Year 1, 

again ensuring even distribution. The 

individual employers you represent are not 

required to provide any blind specimens on 

their own. 

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

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

IITF Y in Year 1. One percent of that figure 

is 400. However, the 50 blind specimen per 

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

50 blind specimens per quarter, rather than 

the 100 per quarter you would have to send 

to meet the one percent rate. Your annual 

total would be 200, rather than 400, blind 

specimens. 

(c) Approximately 75 percent of the 

specimens you submit must be negative 


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(i.e., containing no drugs, nor 

adulterated or substituted). 

Approximately 15 percent must be 

positive for one or more of the five 

drugs involved in DOT tests, and 

approximately 10 percent must either be 

adulterated with a substance cited in 

HHS guidance or substituted (i.e., 

having specific gravity and creatinine 

meeting the criteria of § 40.93(b)). 

* * * * * 

(d) You must ensure that each blind 

specimen is indistinguishable to the 

laboratory or IITF from a normal 

specimen. 

(1) You must submit blind specimens 

to the laboratory or IITF using the same 

channels (e.g., via a regular collection 

site) through which employees’ 

specimens are sent to the laboratory or 

IITF. 

* * * * * 

21. In § 40.105, the section heading 

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

to read as follows: 

§ 40.105 What happens if the laboratory or 

IITF reports a result different from that 

expected for a blind specimen? 

* * * * * 

(b) If the unexpected result is a false 

negative, you must provide the 

laboratory or IITF with the expected 

results (obtained from the supplier of 

the blind specimen), and direct the 

laboratory or IITF to determine the 

reason for the discrepancy. 

(c) If the unexpected result is a false 

positive, adulterated, or substituted 

result, you must provide the laboratory 

or IITF with the expected results 

(obtained from the supplier of the blind 

specimen), and direct the laboratory or 

IITF to determine the reason for the 

discrepancy. You must also notify 

ODAPC of the discrepancy by telephone 

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

listed on the ODAPC Web site, http:// 

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

notify HHS who will take appropriate 

action. 

22. Section 40.107 is revised, to read 

as follows: 

§ 40.107 Who may inspect laboratories or 

IITFs? 

As a laboratory or IITF, you must 

permit an inspection, with or without 

prior notice, by ODAPC, a DOT agency, 

or a DOT-regulated employer that 

contracts with the laboratory or IITF for 

drug testing under the DOT drug testing 

program, or the designee of such an 

employer. 

23. Section 40.109 is revised, to read 

as follows: 

§ 40.109 What documentation must the 

laboratory or IITF keep and for how long? 

(a) As a laboratory or IITF, you must 

retain all records pertaining to each 

employee urine specimen for a 

minimum of two years. 

(b) As a laboratory or IITF, you must 

also keep for two years employerspecific data required in § 40.111. 

(c) Within the two-year period, the 

MRO, the employee, the employer, or a 

DOT agency may request in writing that 

you retain the records for an additional 

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

preserving evidence for litigation or a 

safety investigation). If you receive such 

a request, you must comply with it. If 

you do not receive such a request, you 

may discard the records at the end of 

the two-year period. 

24. Section 40.111 is revised, to read 

as follows: 

§ 40.111 When and how must a laboratory 

or IITF disclose statistical summaries and 

other information it maintains? 

(a) As a laboratory or IITF, you must 

transmit an aggregate statistical 

summary, by employer, of the data 

listed in Appendix B to this part to the 

employer on a semi-annual basis. 

(1) The summary must not reveal the 

identity of any employee. 

(2) In order to avoid sending data 

from which it is likely that information 

about an employee’s test result can be 

readily inferred, you must not send a 

summary if the employer has fewer than 

five aggregate tests results. 

(3) The summary must be sent by 

January 20 of each year for July 1 

through December 31 of the prior year. 

(4) The summary must also be sent by 

July 20 of each year for January 1 

through June 30 of the current year. 

(b) When the employer requests a 

summary in response to an inspection, 

audit, or review by a DOT agency, you 

must provide it unless the employer had 

fewer than five aggregate test results. In 

that case, you must send the employer 

a report indicating that not enough 

testing was conducted to warrant a 

summary. You may transmit the 

summary or report by hard copy, fax, or 

other electronic means. 

(c) You must also release information 

to appropriate parties as provided in 

§§ 40.329 and 40.331. 

(d) As a laboratory or IITF, you must 

transmit an aggregate statistical 

summary of the data listed in Appendix 

C to this part to DOT on a semi-annual 

basis. The summary must be sent by 

January 31 of each year for July 1 

through December 31 of the prior year; 

it must be sent by July 31 of each year 

for January 1 through June 30 of the 

current year. 

25. Section 40.113 is revised, to read 

as follows: 

§ 40.113 Where is other information 

concerning laboratories or IITFs found in 

this regulation? 

You can find more information 

concerning laboratories in several 

sections of this part: 

Sec. 

40.3 Definition. 

40.13 Prohibition on making specimens 

available for other purposes. 

40.31 Conflicts of interest concerning 

collectors. 

40.47 Laboratory or IITF rejections of test 

for improper form. 

40.125 Conflicts of interest concerning 

MROs. 

40.175 Role of first laboratory in split 

specimen tests. 

40.177 Role of second laboratory in split 

specimen tests (drugs). 

40.179 Role of second laboratory in split 

specimen tests (adulterants). 

40.181 Role of second laboratory in split 

specimen tests (substitution). 

40.183–40.185 Transmission of split 

specimen test results to MRO. 

40.201–40.205 Role in correcting errors. 

40.329 Release of information to employees. 

40.331 Limits on release of information. 

40.355 Role with respect to other service 

agents. 

26. In § 40.123, paragraph (b)(1) is 

revised, to read as follows: 

§ 40.123 What are the MRO’s 

responsibilities in the DOT drug testing 

program? 

* * * * * 

(b) * * * 

(1) Ensuring the review of the CCF on 

all specimen collections for the 

purposes of determining whether there 

is a problem that may cause a test to be 

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

MRO, you are not required to review 

laboratory or IITF internal chain of 

custody documentation. No one is 

permitted to cancel a test because you 

have not reviewed this documentation; 

* * * * * 

27. Section 40.125 is revised, to read 

as follows: 

§ 40.125 What relationship may an MRO 

have with a laboratory or IITF? 

As an MRO, you must not enter into 

any relationship with an employer’s 

laboratory or IITF that creates a conflict 

of interest or the appearance of a 

conflict of interest with your 

responsibilities to that employer. You 

must not derive any financial benefit by 

having an employer use a specific 

laboratory or IITF. For examples of 

relationships between laboratories and 

MROs that the Department views as 

creating a conflict of interest or the 

appearance of such a conflict, see 

§ 40.101(b). 


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Federal Register / Vol. 75, No. 23 / Thursday, February 4, 2010 / Proposed Rules 5731 

28. In § 40.127, the introductory text 

and paragraphs (b), (c)(2), (d), (g) 

introductory text, and (g)(3) to read as 

follows: 

§ 40.127 What are the MRO’s functions in 

reviewing negative test results? 

As the MRO, you must do the 

following with respect to negative drug 

test results you receive from a laboratory 

or IITF, prior to verifying the result and 

releasing it to the DER: 

* * * * * 

(b) Review the negative laboratory or 

IITF test result and ensure that it is 

consistent with the information 

contained on the CCF. 

(c) * * * 

(2) A legible copy (fax, photocopy, 

image) of Copy 1 of the CCF or the 

electronic laboratory or IITF results 

report that conveys the negative 

laboratory test result. 

(d) If the copy of the documentation 

provided to you by the collector or 

laboratory or IITF appears unclear, you 

must request that the collector or 

laboratory or IITF send you a legible 

copy. 

* * * * * 

(g) Staff under your direct, personal 

supervision may perform the 

administrative functions of this section 

for you, but only you can cancel a test. 

If you cancel a laboratory or IITFconfirmed negative result, check the 

‘‘Test Cancelled’’ box (Step 6) on Copy 

2 of the CCF, make appropriate 

annotation in the ‘‘Remarks’’ line, 

provide your name, and sign, initial or 

stamp and date the verification 

statement. 

* * * * * 

(3) Your review must, as a minimum, 

include the CCF, negative laboratory or 

IITF test result, any accompanying 

corrective documents, and the report 

sent to the employer. You must correct 

any errors that you discover. You must 

take action as necessary to ensure 

compliance by your staff with this part 

and document your corrective action. 

You must attest to the quality assurance 

review by initialing the CCFs that you 

review. 

* * * * * 

29. 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, or MDMA in a specimen. There are 

no legitimate medical explanations for 

the presence of these substances 

* * * * * 

30. In § 40.155, paragraph (a) is 

revised, to read as follows: 

§ 40.155 What does the MRO do when a 

negative or positive test result is also 

dilute? 

(a) When the laboratory or IITF 

reports that a specimen is dilute, you 

must, as the MRO, report to the DER 

that the specimen, in addition to being 

negative or positive, is dilute. 

* * * * * 

31. In § 40.161, the introductory text 

is revised, to read as follows: 

§ 40.161 What does the MRO do when a 

drug test specimen is rejected for testing? 

As the MRO, when the laboratory or 

IITF reports that the specimen is 

rejected for testing (e.g., because of a 

fatal or uncorrected flaw), you must do 

the following: 

* * * * * 

32. In § 40.203, paragraphs (a) and 

(d)(3) are revised, to read as follows: 

§ 40.203 What problems cause a drug test 

to be cancelled unless they are corrected? 

(a) As the MRO, when a laboratory or 

IITF discovers a ‘‘correctable flaw’’ 

during its processing of incoming 

specimens (see § 40.83), the laboratory 

or IITF will attempt to correct it. If the 

laboratory or IITF is unsuccessful in this 

attempt, it will report to you that the 

specimen has been ‘‘Rejected for 

Testing’’ (with the reason stated). 

* * * * * 

(d) * * * 

(3) The collector uses a non-Federal 

form or an expired Federal form for the 

test. This flaw may be corrected through 

the procedure set forth in § 40.205(b)(2), 

provided that the collection testing 

process has been conducted in 

accordance with the procedures of this 

part in an HHS-certified laboratory or 

IITF. If the problem is not corrected, you 

must cancel the test. 

33. In § 40.205, paragraphs (b) 

introductory text and (b)(2) are revised, 

to read as follows: 

§ 40.205 How are drug test problems 

corrected? 

* * * * * 

(b) If, as a collector, laboratory or IITF, 

MRO, employer, or other person 

implementing these drug testing 

regulations, you become aware of a 

problem that can be corrected (see 

§ 40.203), but which has not already 

been corrected under paragraph (a) of 

this section, you must take all 

practicable action to correct the problem 

so that the test is not cancelled. 

* * * * * 

(2) If the problem is the use of a nonFederal form or an expired Federal 

form, you must provide a signed 

statement (i.e., a memorandum for the 

record). It must state that the incorrect 

form contains all the information 

needed for a valid DOT drug test, and 

that the incorrect form was used 

inadvertently or as the only means of 

conducting a test, in circumstances 

beyond your control. The statement 

must also list the steps you have taken 

to prevent future use of non-Federal 

forms or expired Federal forms for DOT 

tests. For this flaw to be corrected, the 

test of the specimen must have occurred 

at a HHS-certified laboratory or IITF 

where it was tested consistent with the 

requirements of this part. You must 

supply this information on the same 

business day on which you are notified 

of the problem, transmitting it by fax or 

courier. 

* * * * * 

34. In § 40.208, paragraph (a) is 

revised, to read as follows: 

§ 40.208 What problem requires corrective 

action but does not result in the 

cancellation of a test? 

(a) If, as a laboratory or IITF, collector, 

employer, or other person implementing 

the DOT drug testing program, you 

become aware that the specimen 

temperature on the CCF was not 

checked and the ‘‘Remarks’’ line did not 

contain an entry regarding the 

temperature being out of range, you 

must take corrective action, including 

securing a memorandum for the record 

explaining the problem and taking 

appropriate action to ensure that the 

problem does not recur. 

* * * * * 

35. In § 40.209, the section heading 

and paragraphs (a) and (b)(9) are 

revised, to read as follows: 

§ 40.209 What procedural problems do not 

result in the cancellation of a test and do 

not require corrective action? 

(a) As a collector, laboratory or IITF, 

MRO, employer or other person 

administering the drug testing process, 

you must document any errors in the 

testing process of which you become 

aware, even if they are not considered 

problems that will cause a test to be 

cancelled as listed in this subpart. 

Decision about the ultimate impact of 

these errors will be determined by other 

administrative or legal proceeding, 

subject to limitation of paragraph (b) of 

this section. 

(b) * * * 

(9) Personal identifying information is 

inadvertently contained on the CCF 

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

on the laboratory or IITF copy 1); or 

* * * * * 


jlentini on DSKJ8SOYB1PROD with PROPOSALS
5732 Federal Register / Vol. 75, No. 23 / Thursday, February 4, 2010 / Proposed Rules 

36. In § 40.329, the section heading 

and paragraph (b) are revised, to read as 

follows: 

§ 40.329 What information must 

laboratories, MROs, and other service 

agents release to employees? 

* * * * * 

(b) As a laboratory or IITF, you must 

provide, within 10 business days of 

receiving a written request from an 

employee, and made through the MRO, 

the records relating to the results of the 

employee’s drug test (i.e., laboratory or 

IITF) report and data package). You may 

charge no more than the cost of 

preparation and reproduction for copies 

of these records. 

* * * * * 

37. In § 40.355, the introductory text, 

paragraphs (a) through (c), and 

paragraph (l) are revised, to read as 

follows: 

§ 40.355 What limitations apply to the 

activities of service agents? 

As a service agent, you are subject to 

the following limitations concerning 

your activities in the DOT drug and 

alcohol testing program. 

(a) You must not require an employee 

to sign a consent, release, waiver of 

liability, or indemnification agreement 

with respect to any part of the drug or 

alcohol testing process covered by this 

part (including, but not limited to, 

collections, laboratory or IITF testing, 

MRO, and SAP services). No one may 

do so on behalf of a service agent. 

(b) You must not act as an 

intermediary in the transmission of drug 

test results from the laboratory or IITF 

to the MRO. That is, the laboratory or 

IITF must not send results to you, with 

you in turn sending them to the MRO 

for verification. For example, a practice 

in which the laboratory or IITF 

transmits results to your computer 

system, and you then assign the results 

to a particular MRO is not permitted. 

(c) You must not transmit drug test 

results directly from the laboratory or 

IITF to the employer (by electronic or 

other means) or to a service agent who 

forwards them to the employer. All 

confirmed laboratory or IITF results 

must be processed by the MRO before 

they are released to any other party. 

* * * * * 

(l) In transmitting documents to 

laboratories or IITFs, you must ensure 

that you send to the laboratory or IITF 

that conducts testing only the laboratory 

copy of the CCF. You must not transmit 

other copies of the CCF or any ATFs to 

the laboratory or IITF. 

* * * * * 

38. Appendix B is revised, to read as 

follows: 

Appendix B to Part 40—DOT Drug 

Testing Semi-Annual Laboratory or 

IITF Report to Employers 

Laboratory Report to Employer 

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) 

(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) 

IITF Report to Employer 

The following items are required on each 

IITF report: 

Reporting Period: (inclusive dates) 

IITF 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. Number of specimens forwarded to an 

HHS-certified laboratory for additional 

drug testing and/or specimen validity 

testing. 

39. Appendix C is revised, to read as 

follows: 

Appendix C to Part 40—DOT Drug 

Testing Semi-Annual Laboratory or 

IITF 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 

laboratory report: 

Reporting Period: (inclusive dates) 

Laboratory Identification: (name and address) 

1. DOT Specimen Results Reported (number) 

2. Negative Results Reported (number) 

Negative (number) 

Negative-Dilute (number) 

3. Rejected for Testing Reported (number) 

By Reason (number) 

4. Positive Results Reported (number) 

By Drug (number) 

5. Adulterated Results Reported (number) 

By Reason (number) 

6. Substituted Results Reported (number) 

7. Invalid Results Reported (number) 

By Reason (number) 

The following items are required on each 

IITF report: 

Reporting Period: (inclusive dates) 

IITF Identification: (name and address) 

1. DOT Specimen Results Reported (number) 

2. Negative Results Reported (number) 

Negative (number) 

Negative-Dilute (number) 

3. Rejected for Testing Reported (number) 

By Reason (number) 

4. Specimens forwarded to an HHS-certified 

laboratory for additional testing 

(number) 

For Drugs (number) 

For SVT (number) 

[FR Doc. 2010–2315 Filed 2–3–10; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

50 CFR Part 17 

[FWS–R2–ES–2009–0077; 92220–1113– 

0000; ABC Code: C3] 

RIN 1018–AW63 

Endangered and Threatened Wildlife 

and Plants; Establishment of a 

Nonessential Experimental Population 

of Sonoran Pronghorn in 

Southwestern Arizona 

AGENCY: Fish and Wildlife Service, 

Interior. 


jlentini on DSKJ8SOYB1PROD with PROPOSALS