62276 Federal Register / Vol. 70, No. 209 / Monday, October 31, 2005 / Proposed Rules 

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Dated: October 25, 2005. 

Brent Fewell, 

Acting Assistant Administrator Office of 

Water. 

[FR Doc. 05–21527 Filed 10–28–05; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF TRANSPORTATION 

Office of the Secretary 

49 CFR Part 40 

[Docket OST–2003–15245] 

RIN 2105–AD55 

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 and 

alcohol testing procedures to change 

instructions to laboratories, medical 

review officers, and employers with 

respect to adulterated, substituted, 

diluted, and invalid specimen results. 

These proposed changes are intended to 

create consistency with specimen 

validity requirements established by the 

U.S. Department of Health and Human 

Services and to modify some measures 

taken in two of our own interim final 

rules. This NPRM also proposes to make 

specimen validity testing mandatory 

within the regulated transportation 

industries. 

DATES: Comments to the notice of 

proposed rulemaking should be 

submitted by December 30, 2005. Latefiled comments will be considered to 

the extent practicable. 

ADDRESSES: You may submit comments 

[identified by DOT DMS Docket Number 

15245] by any of the following methods: 

• Web Site: http://dms.dot.gov. 

Follow the instructions for submitting 

comments on the DOT electronic docket 

site. 

• Fax: 1–202–493–2251. 

• Mail: Docket Management Facility; 

U.S. Department of Transportation, 400 

Seventh Street, SW., Nassif Building, 

Room PL–401, Washington, DC 20590–

0001. 

• Hand Delivery: Room PL–401 on 

the plaza level of the Nassif Building, 

400 Seventh Street, SW., Washington, 

DC, between 9 am and 5 pm, Monday 

through Friday, except Federal 

Holidays. 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov. Follow the 

online instructions for submitting 

comments. 

Instructions: All submissions must 

include the agency name and docket 

number or Regulatory Identification 

Number (RIN) for this rulemaking. For 

detailed instructions on submitting 

comments and additional information 

on the rulemaking process, see the 

Public Participation heading of the 

Supplementary Information section of 

this document. Note that all comments 

received will be posted without change 

to http://dms.dot.gov. including any 

personal information provided. Please 

see the Privacy Act heading under 

Regulatory Notices. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

dms.dot.gov at any time or to Room PL–

401 on the plaza level of the Nassif 

Building, 400 Seventh Street, SW., 

Washington, DC, between 9 am and 5 

pm, Monday through Friday, except 

Federal Holidays. 

FOR FURTHER INFORMATION CONTACT: Jim 

L. Swart, Deputy Director (S–1), Office 

of Drug and Alcohol Policy and 

Compliance, 400 Seventh Street, SW., 

Washington, DC 20590; telephone 

number 202–366–3784 (voice), 202–

366–3897 (fax), or jim.swart@dot.gov (email). 

SUPPLEMENTARY INFORMATION: 

Purpose 

In its final rule of December 2000 [65 

FR 79526], the U.S. Department of 

Transportation (DOT) made 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 

41952, August 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 

specimen validity testing (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] published on November 9, 2004, 

the DOT changed a number of items in 

part 40 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 notice of proposed 

rulemaking (NPRM). We also indicated 

that we would also take into 

consideration any subsequent HHS 

handbook materials (e.g., HHS MRO 

Manual) and update our cost figures for 

SVT in the context of making SVT 

mandatory. In this NPRM, we have 

considered the HHS Guidelines as well 

as the HHS MRO Manual, we propose 

to make SVT mandatory, and we have 

updated our cost figures accordingly. 

In the 2004 IFR and an earlier IFR [68 

FR 31626] from May 28, 2003, we 

solicited comments regarding SVT and 

substituted specimens. We will address 

the docket comments to both IFRs in 

this preamble. 

Background 

We issued the 2003 IFR in order to 

respond to scientific and medical 

information suggesting we modify 

testing criteria for some specimens that 

had been considered to be substituted 

and ultimately were treated as refusals 

to test. The 2003 IFR modified how 

MROs would deal with any substituted 

result with creatinine concentration 

greater than or equal to 2 mg/dL. It did 

not change the HHS substitution criteria 

that we had used. 

In the 2004 IFR, we changed a number 

of items in part 40 to harmonize part 40 

and the new HHS Mandatory Guidelines 

on SVT to avoid a number of 

inconsistent requirements that the 

Federal Register / Vol. 70, No. 209 / Monday, October 31, 2005 / Proposed Rules 62277 

application of both rules would likely 

have created for laboratories and MROs. 

While the HHS Mandatory Guidelines 

approach to substituted test results 

allowed DOT to simplify its guidance to 

MROs on how to deal with those results, 

there were several important items upon 

which the 2004 IFR and the HHS 

Guidelines differed. The most important 

among them was the fact that SVT, 

though authorized by part 40 and the 

IFR, was not yet required. 

The 2000 part 40 anticipated that 

HHS would, sometime in 2001, amend 

its Mandatory Guidelines to establish 

SVT requirements for HHS-certified 

laboratories. When it appeared that HHS 

would not establish final SVT 

requirements in 2001, we amended part 

40 to remove the mandatory 

requirement. This was because we 

believed it was advisable to wait until 

HHS completed its amendment before 

making SVT mandatory throughout the 

transportation industries for all DOT 

specimens. This NPRM proposes that 

SVT be made mandatory, as the DOT 

said it intended to do in its final rule of 

December 2000. 

Principal Policy Issues 

Harmonization With HHS 

In this NPRM we have sought to 

harmonize our SVT proposals for 

laboratories, MROs, and employers with 

the requirements contained in the HHS 

Mandatory Guidelines and the HHS 

Medical Review Officer Manual. Here 

are the most noteworthy of the 

coordinated proposals: 

1. We propose to make SVT 

mandatory—like it is now with the HHS 

Federal employee testing program. 

2. We would continue to utilize HHS 

instructions to laboratories for 

establishing and directing laboratory 

actions for SVT. We will also continue 

to look to HHS for establishing 

appropriate cutoffs. An HHS-certified 

laboratory’s testing equipment and SVT 

parameters are all HHS-driven. Our 

proposed tables related to adulterated 

and invalid laboratory results are 

primarily designed to explain and 

instruct HHS criteria rather than 

establish new criteria. 

3. We propose to modify some of our 

definitions and add a few new 

definitions in order to make them 

consistent with HHS Mandatory 

Guidelines definitions. 

4. We would continue to require 

laboratories to contact MROs when the 

laboratories find specific types of 

invalid results. 

5. Regarding multiple results actions 

and reporting for primary specimens, 

we would generally adopt HHS 

procedures both for laboratories and 

MROs. Uniquely to part 40, we propose 

‘‘categories’’ of results in order to make 

it easier for MROs to understand what 

they are to do when verifying laboratory 

results and reporting their verified 

results. 

6. Regarding the numerous possible 

laboratory and MRO actions for split 

specimens, we would generally adopt 

HHS procedures both for laboratories 

and MROs. As with primary specimen 

results, we propose categories of split 

results designed to make it easier for 

MROs to verify and report results. 

7. We propose to clarify that split 

testing is still not offered for invalid 

results. The HHS MRO Manual makes 

this a clear point. 

8. We propose that if a second invalid 

result (collected under direct 

observation) occurs but for a different 

reason than the first invalid result, the 

verified result of the test event will be 

a refusal. This is also consistent with 

the HHS MRO Manual. 

9. We propose to adopt HHS blind 

specimen certification criteria. 

10. We propose to adopt HHS SemiAnnual Laboratory Report items. 

While we have sought to harmonize 

our requirements with those of HHS, 

there remain a few issues for which we 

have not proposed changes to 

procedures that were in the 2004 IFR or 

in part 40. Perhaps the most important 

one is that we have not proposed to 

modify the requirement that MROs treat 

laboratory reported negative-dilute 

results with creatinine levels greater 

than or equal to 2 mg/dL but less than 

or equal to 5 mg/dL (hereafter ‘‘2–5mg/ 

dL range’’) as negative-dilutes that 

require immediate recollections under 

direct observation. We also have not 

proposed changes to the employer 

policy recollection option for other 

negative-dilutes. By contrast, HHS treats 

all negative-dilutes in the same 

fashion—a Federal agency may collect 

the employee’s specimen under direct 

observation during the employee’s next 

scheduled test event. 

While we believe there are employees 

normally able to produce these 2–5 mg/ 

dL range negative-dilute specimen 

results, there are others who cannot 

produce them without tampering with 

their specimens. We are also aware of 

challenges an employer faces in tracking 

an employee’s test selection in order to 

have the next collection directly 

observed, especially as time passes 

between testing events. Therefore, some 

negative-dilutes will continue to require 

recollection under direct observation 

while others may continue to follow the 

employer policy options of immediate 

recollections not under direct 

observation. 

There is also a difference between the 

HHS Mandatory Guidelines and this 

NPRM concerning how we intend to 

address an MRO’s receiving a series of 

invalid test results from the same 

employee for the same testing event. If 

the employee presents two invalid 

results for the same reason or when the 

employee has a long-term medical 

condition that causes an invalid result, 

we propose a way to have MROs obtain 

a negative result if one is needed for 

pre-employment, return-to-duty, and 

follow-up testing. Also, we propose to 

have MROs deal with an invalid result 

when the specimen is also positive, 

substituted, and/or adulterated. 

For instance, the HHS MRO Manual 

directs MROs to report negative results 

if the initial invalid results and the 

subsequent directly observed results are 

invalid for the same reason. The DOT 

will continue to consider these to be 

cancelled tests because laboratories do 

not report invalid-negative results. If a 

negative result is needed because the 

testing event is pre-employment, returnto-duty, or follow-up, the NPRM 

proposes to have the MRO determine if 

there is clinical evidence that the 

employee is an illicit drug user. We 

propose the same clinical evidence 

determination if the employee has a 

long-term medical condition that causes 

the invalid result and needs a negative 

result. These clinical evidence 

evaluations are proposed to be identical 

to the evaluation currently required at 

§ 40.195 when an employee is unable to 

provide a sufficient amount of urine 

because of a permanent or long-term 

medical condition. 

Like HHS, we would have MROs 

follow review procedures, as 

appropriate, for all laboratory reported 

results and to report all verified results 

to employers. But unlike HHS, we 

propose having an exception that deals 

with MROs reporting multiple results 

when one of them is invalid. The NPRM 

would not require an MRO to report an 

invalid result if the MRO also verifies 

any other laboratory result for the 

specimen as positive and/or refusal to 

test. MROs have told us it is problematic 

for them to report cancelled-invalid 

tests in conjunction with positives or 

refusals. MROs and employers have 

questioned whether the required recollection under direct observation 

needs to take place. 

We have not proposed adopting the 

HHS MRO Manual requirement that an 

MRO report a negative result if the 

medical explanation for a substituted 

specimen appears legitimate to the 

MRO. We believe that HHS has taken 

62278 Federal Register / Vol. 70, No. 209 / Monday, October 31, 2005 / Proposed Rules 

ample measures to accurately identify 

substituted specimens by adjusting the 

creatinine concentration criteria 

laboratories need in order to report 

specimens as substituted. Part 40 will 

continue to have MROs report these 

verified results as cancelled, and report 

their determinations and basis for them 

to us. If the DOT begins to receive 

reports that MROs are canceling 

substituted specimen results because of 

legitimate medical reasons, we would be 

prepared to take measures needed for 

employees to obtain negative results 

(when negatives are needed for preemployment, return-to-duty, and followup testing), perhaps by considering 

ways for MROs to determine if there is 

clinical evidence that an employee is an 

illicit drug user. 

Making SVT Mandatory 

As we said in 2000, mandatory 

laboratory testing for specimen validity 

is an appropriate response to those who 

would tamper with the DOT’s drug test 

results. Again, we propose the same 

position. It was the correct position in 

2000, and we think it is the correct 

position now. Over the past several 

years, there have been an increasing 

number of products designed and 

marketed to adulterate specimens. 

Currently, there are more than 400 

different products available for 

adulterating specimens, although many 

contain the same component 

adulterants. There are also devices 

marketed with the promise to hide drug 

use by substituting ‘‘clean’’ urine for a 

drug user’s own urine. The cheating 

industry is real, and we must counter it. 

Furthermore, cheating on a drug test 

through adulteration or substitution is a 

deliberate and direct attempt to thwart 

the testing process. Therefore, we are 

proposing to require SVT for all DOT 

specimens. 

In their Mandatory Guidelines, HHS 

established SVT requirements with 

which laboratories must comply in 

order to become and remain HHScertified. HHS has stated that their SVT 

standards are designed to produce the 

most accurate, reliable, and correctly 

interpreted test results. Currently, when 

DOT specimens are tested for validity, 

the SVT adheres to HHS procedural 

standards. 

In 2000, we estimated an annual cost 

associated with SVT of about $1.4 

million. At that time, a majority of HHScertified laboratories were already 

conducting SVT. The larger laboratories, 

who were receiving the vast majority of 

transportation industry specimens, were 

all conducting SVT. These facts led us 

to estimate approximately 80% of 

industry specimens were being tested 

for specimen validity in 2000. 

Because employers are deeply 

concerned about specimen tampering 

and because HHS certification relies (in 

part) upon a laboratory’s ability to 

conduct SVT, we estimate that an even 

higher percentage of transportation 

industry specimens are undergoing SVT 

now than in 2000. We estimate that 95% 

of industry specimens are undergoing 

SVT, up from 80% in 2000. 

That higher percentage coupled with 

the fact that fewer specimens are being 

collected now than were collected in 

2000, leads us to believe the increased 

cost of requiring SVT for those 

specimens not currently undergoing 

SVT will be even less than our 2000 cost 

estimate. There were 6.67 million 

industry tests conducted in 2005, down 

from 7 million industry tests in 2000. 

Therefore, we estimate that the cost of 

new SVT will be about $1 million, 

down from the $1.4 million figure 

estimated in 2000. 

2003 IFR Comments to the Docket 

The comments to the May 28, 2003 

IFR were generally supportive of the 

DOT’s decision to modify the creatinine 

levels required to call a substituted 

specimen ‘‘a refusal to test.’’ Some 

supported the DOT’s diligence in 

pursuing the subject of creatinine levels 

of substituted specimens, and a few 

others expressed the desire to do away 

with SVT altogether. Another 

commenter said we were making an 

accommodation for a situation that was 

likely not to exist, so this commenter 

recommended that the DOT make no 

change with regard to substituted 

specimen refusals. 

Most comments to the docket 

expressed, in one form or another, the 

desire to have SVT laboratory standards 

developed and issued in final guidance 

by HHS. That way, commenters 

reasoned, all laboratories would be 

responsible for adhering to the SVT 

standards and would be held 

accountable for them. These 

commenters had a variety opinions 

related to the cutoff levels and testing 

ranges for SVT. Most indicated that they 

had provided similar comments to HHS 

when it proposed SVT for the 

Mandatory Guidelines. A few 

commenters discussed procedural 

issues for MROs in dealing with 

substituted specimens with creatinine 

in the 2–5 mg/dL range and with the 

period of time the IFR allowed for an 

employee’s obtaining a required for 

medical evaluation. 

Additionally, several comments (from 

an employee, two employee 

associations, and an attorney) expressed 

the desire to have the DOT remedy the 

records of employees whose refusals to 

test prior to May, 2003, had been the 

result of having substituted specimens. 

Their specific gravity levels had been in 

the substituted range, but their 

creatinine had apparently been in the 2–

5 mg/dL range. At least two commenters 

brought up issues totally unrelated to 

SVT. 

2004 IFR Comments to the Docket 

The comments to the November 9, 

2004 IFR, especially those from 

laboratories, were favorable about the 

DOT’s decision to take measures to align 

part 40 with HHS SVT procedures. One 

association requested that we go further 

with the alignment by making SVT 

mandatory rather than leaving it 

optional. One Third Party Administrator 

(TPA) recommended that we provide 

guidance on who (e.g., employer, 

laboratory, TPA) makes the decision to 

authorize SVT. 

Two MROs favored the DOT’s 

decision to keep their 2003 IFR 

requirement to order an immediate 

recollection under direct observation 

when a verified negative-dilute that 

contained creatinine in the 2–5 mg/dL 

range. One of those MROs spoke about 

what he considered the high rate of 

positive results for those recollections. 

However, one employee association was 

opposed to the recollection requirement 

for creatinine in the 2–5 mg/dL range. 

In fact, the association wanted the DOT 

to do away with the below 2 creatinine 

substitution criteria established by HHS, 

in essence wanting there to be no 

specimens considered substituted. 

Additionally, the association also 

expressed a desire to have the DOT 

expunge the records of those employees 

with substitution refusals prior to May, 

2003. Their specific gravity levels had 

been in the substituted range, but their 

creatinine had tested in the 2–5 mg/dL 

range. 

A laboratory requested that we require 

laboratories to report quantitative values 

on all dilutes (not just negative-dilutes) 

because, in the event a positive-dilute 

was downgraded by the MRO, the 

creatinine level would be important for 

the MRO to know. About negativedilutes, one of the MROs suggested the 

category of dilute specimens having 

creatinine above 5 mg/dL was 

superfluous to the process. He suggested 

doing away with that category of dilute 

results altogether. 

One of the TPAs recommended the 

Department find an easier way for 

employers to determine which 

laboratories use two SVT 

methodologies, rather than one, so that 

the number of invalid results would be 

Federal Register / Vol. 70, No. 209 / Monday, October 31, 2005 / Proposed Rules 62279 

kept to a minimum. The TPA 

recommended that HHS amend its 

laboratory certification list to 

accommodate this request. Also, the 

TPA recommended that we use [for 

example], ‘‘As an MRO, you must 

‘‘***’’ throughout part 40 as a means 

of making it easier to figure out whose 

actions are being directed. 

DOT Response to the 2003 and 2004 IFR 

Comments to the Docket 

A major factor in the DOT’s decisions 

to withdraw part 40’s mandatory SVT 

(in 2001) and to create the 2003 IFR 

regarding MRO actions on laboratory 

reported substituted specimens was the 

fact that HHS had not finalized or 

updated SVT in their Mandatory 

Guidelines. Likewise, our decisions to 

establish the 2004 IFR—which served to 

bring part 40’s SVT more in-line with 

the HHS—and to write this NPRM were 

based upon the fact that HHS finalized 

and published its Mandatory Guidelines 

effective November 1, 2004. 

The HHS Mandatory Guidelines have 

gone far toward alleviating many of the 

concerns of the commenters. 

Specifically, IFR commenters explained 

that no mandatory SVT standards 

existed for laboratories to follow. They 

were also concerned that the DOT 

program operated with different SVT 

criteria than the HHS program. They 

noted the laboratories were not certified 

for their abilities to conduct SVT, and 

that appropriate procedures and cutoff 

criteria for SVT had not been 

established by HHS. Under the new 

HHS Mandatory Guidelines, HHS has 

set mandatory SVT standards. HHS 

certification depends upon laboratory 

SVT capabilities (among other things), 

and HHS has established appropriate 

SVT reporting criteria and cutoff levels. 

Nonetheless, there will continue to be 

some disagreement between those who 

desire to have no SVT and those who 

believe the established SVT criteria are 

not stringent enough. However, we are 

proposing that all DOT specimens be 

tested for all SVT, and that those tests 

will follow procedures and cutoff 

criteria established in the HHS 

Mandatory Guidelines. We believe the 

HHS has presented well-reasoned 

Mandatory Guidelines and have, in the 

preamble to that document, forthrightly 

explained their ongoing review and 

analysis of SVT results and scientific 

criteria. 

Also, we believe the Mandatory 

Guidelines work well in harmonizing 

with the 2000 part 40’s positions to 

make SVT mandatory, to grant 

employees the right of MRO review and 

split specimen testing for SVT, and to 

provide (in certain instances) for the 

retesting of the primary specimen for 

SVT if the split specimen fails to 

reconfirm a drug metabolite. In 

addition, the Mandatory Guidelines 

reflect the DOT’s desire (as made 

operational by the 2003 IFR) to change 

the creatinine criteria needed (in 

addition to the long-required specific 

gravity criteria) to call a specimen 

substituted. 

IFR issues related to a laboratory’s use 

of two SVT methodologies versus one, 

MRO and employer actions with 

negative-dilute specimens having 

creatinine in the 2–5 mg/dL range, and 

laboratories reporting creatinine values 

for positive-dilute specimens are fully 

expanded in a later section called Other 

NPRM Issues and Questions. 

Regarding the 2004 IFR comment 

asking us to clarify which persons or 

entities currently provide authorization 

for a laboratory to conduct SVT under 

the DOT program, the authorization 

comes from part 40. Having said that, 

until part 40 makes SVT mandatory 

(rather than authorized), employers 

need to take active roles in determining 

the SVT they want laboratories to 

conduct on their behalf. The contracts 

between employers and laboratories are 

important. A laboratory needs to let 

employers know the SVT available to 

them and whether the laboratory uses 

two separate methodologies or one 

when conducting SVT. The more 

prudent employers will likely select a 

full range of SVT. The DOT appreciates 

the fact that most DOT-regulated 

specimens are undergoing SVT and 

would encourage employers to conduct 

the full range of SVT. 

Finally, the DOT views the NPRM as 

an opportunity to consider our positions 

on SVT and propose modifications 

accordingly. It was not our intention to 

conduct a full review of part 40. Nor 

was it our intention to focus on issues 

that fall under the sole purviews of HHS 

Mandatory Guidelines (e.g., the contents 

of the HHS laboratory listing) and DOT 

agency regulations (e.g., the make-up of 

‘‘actual knowledge’’ provisions). 

Therefore, we have no responses to IFR 

comments addressing such topics. 

DOT Response to 2003 and 2004 IFR 

Comments Requesting That the 

Department Rectify Past Substitution 

Refusals 

In both the 2003 and 2004 IFRs, there 

were calls for the DOT to take action to 

rectify what several commenters 

believed to be a mischaracterization of 

some employee refusals to test. Some of 

the comments suggest that we take 

measures to clear employee records of 

refusals to test if their substituted 

refusals showed creatinine in the 2–5 

mg/dL range and those refusals were 

reported between September 1998 and 

May 2003. 

For this discussion, there are several 

important time-lines and actions to take 

into consideration: 

1. In September 1998, HHS 

established guidance regarding 

laboratory testing requirements for 

determining if a urine specimen should 

be reported to the MRO as being 

substituted. Specimens had two testing 

criteria in order to be reported as 

substituted: The specimen’s creatinine 

level must have been 5 mg/dL or less 

and the specimen’s specific gravity 

must have been less than or equal to 

1.001 or greater than or equal to 1.020. 

2. In December 2000, part 40 

implemented procedures for MRO 

review and for split specimen testing for 

SVT, to include substituted specimens. 

Therefore, employees could show MROs 

that they had medical reasons for 

producing the result and proof they 

could naturally produce substituted 

specimens. By doing so, their results 

would be cancelled. 

3. We issued the 2003 IFR so that 

MROs would not treat substituted 

specimens with creatinine 

concentration in the 2–5 mg/dL range as 

substituted specimens. 

4. Nearly a year later, HHS revised 

their Mandatory Guidelines with an 

effective date of November 1, 2004. 

Among the revisions contained in the 

HHS Mandatory Guidelines was the 

requirement that laboratories modify 

substituted specimen criteria. As a 

result, there are no specimens with 

creatinine levels greater than or equal to 

2 mg/dL being reported by laboratories 

as substituted. 

The question now is whether we 

should so do something about those 

employees who may have been 

incorrectly charged with refusing their 

drug tests because they had substituted 

specimens with creatinine in the 2–5 

mg/dL range. The answer is that we 

should. 

Consequently, the DOT will issue an 

Informational Notice, separately from 

this NPRM, directing action on this 

matter. The notice permits employees to 

present information to us showing that 

they had a refusal to test before May 

2003. The reason for the refusal must be 

based upon the employee’s having a 

substituted specimen result with a 

creatinine concentration in the 2–5 mg/ 

dL range. Employees will also have to 

present proof that they are able to 

produce such specimens by virtue of 

medical evaluations. If the DOT 

determines that an employee’s refusal 

fell within these parameters and the 

supporting documentation shows that 

62280 Federal Register / Vol. 70, No. 209 / Monday, October 31, 2005 / Proposed Rules 

the employee can produce such 

specimens, we will reconsider the 

employee’s original refusal-to-test 

result. 

Section-by-Section NPRM Issues 

1. Index Changes—We would modify 

some existing section headings and 

added three new section headings in 

order to reflect regulation text changes. 

All told, eight section headings have 

been modified or added. 

2. Definition changes—In order to 

align more closely our definitions 

section (§ 40.3) with definitions 

contained in the HHS Mandatory 

Guidelines, we propose to modify some 

of our existing definitions and add some 

new ones. Eleven definitions would be 

modified or added to harmonize with 

HHS definitions. 

3. SVT Mandatory—We would make 

SVT mandatory by removing the option 

to conduct SVT (at § 40.89) and adding 

text requiring SVT. This text is similar 

to the wording that had been removed 

from part 40 in 2001. 

4. Adulterant and Invalid Testing 

Cutoffs—We propose to add two tables 

(one at the existing § 40.95, the other at 

a new § 40.96) which will serve to 

inform MROs and others about the 

cutoffs and procedures laboratories are 

directed by HHS to use in reporting 

adulterants and invalid test results. 

However, we seek comment on whether 

this information will be helpful to 

MROs and other service agents or 

whether it will prove to be too much 

information that is too complicated to 

add value to the testing process. 

5. Primary Specimen Laboratory 

Results—Laboratories are reporting and 

MROs are reviewing a variety of test 

results, to include multiple test results 

for the same testing event. We believe 

that proposed changes to § 40.97—

which highlight categories of primary 

results—and the sections related to 

medical review and reporting, 

especially §§ 40.159(f) and 40.162, will 

make it easier for laboratories and MROs 

to understand how to deal with and 

report multiple test results. Comments 

from MROs regarding these categories of 

results will prove especially useful to 

us. 

6. Reporting Invalid Results with No 

Employee Interview—MROs have 

informed us of situations in which 

neither they nor the employers were 

able to contact employees to complete 

the interview process for invalid results. 

These MROs have wondered how they 

are to close these results. We propose to 

modify § 40.133 so that invalids will be 

handled parallel to part 40’s directives 

on positive, adulterated, and substituted 

specimens when the employee cannot 

be interviewed. 

7. Closing the Invalid Loops—The 

NPRM addresses the issues an MRO 

faces when the employee produces a 

second invalid result after providing a 

recollection under direct observation 

because of an initial invalid result. The 

NPRM also addresses what an MRO is 

to do after an invalid test result is 

cancelled by the MRO because of a 

legitimate reason and a negative result 

is required (i.e., because the test type is 

pre-employment, return-to-duty, or 

follow-up). 

a. Regarding a second invalid result 

for the same reason, we would amend 

§ 40.159 to require the MRO to report 

the test result as canceled after 

confirming with the collector that the 

collection had been properly observed. 

b. Regarding a second invalid result 

for a different reason, we would amend 

§ 40.159 to require the MRO to report 

the test result as a refusal after 

confirming with the collector that the 

collection had been properly observed. 

At § 40.191, we would add this to the 

list of what constitutes a refusal to take 

a DOT test. This refusal requirement is 

in alignment with the HHS MRO 

Manual. 

c. Regarding obtaining a negative 

result when a valid test result cannot be 

produced and a negative result is 

needed, we propose to add a new 

§ 40.160 which requires the MRO to 

determine if there is clinical evidence 

that the individual is an illicit drug 

user. The evaluation requirements in 

this section would be parallel to existing 

part 40 requirements at § 40.195 when a 

permanent or long term medical 

condition is the cause of the inability to 

provide a sufficient specimen and a 

negative result is needed. Like § 40.195, 

the medical procedures would apply 

only when a negative result is needed 

for pre-employment, return-to-duty, and 

follow-up testing. Also, we seek 

comments about findings of illicit drug 

use during these medical evaluations. 

Currently, a finding of illicit drug use 

during the medical evaluation under 

§ 40.195 causes the test to be cancelled. 

Should the DOT continue to require that 

the tests be cancelled or treat them as 

positives? 

8. Split Specimen Results—Because of 

the myriad of possible test results, 

perhaps no section of the HHS 

Mandatory Guidelines is more complex 

than the one dedicated to split 

specimens. In the NPRM, we have 

attempted to categorize the split 

results—much the same way we did for 

the primary results—in order to make it 

easier for MROs to understand their 

responsibilities should they receive any 

of the more complicated split result 

possibilities. Comments from MROs 

regarding these categories of results will 

prove especially useful to us. Also, we 

seek comments on whether a table in 

the Appendix would help make the 

MRO’s split specimen requirements 

easier to understand. 

a. We would amend § 40.171 to state 

that there is no split specimen testing 

for an invalid result. This is consistent 

with current part 40 split request 

procedures and with the HHS MRO 

Manual. 

b. We propose to amend §§ 40.177, 

40.179, and 40.181 so that a provision 

currently contained only in § 40.177 is 

expanded to the adulterated and 

substituted split sections. Under the 

proposal, we would provide 

authorization for the split laboratory to 

forward the split specimen or a portion 

of it to another HHS-certified laboratory 

if the split fails to reconfirm the 

presence of validity criteria. We believe 

the provision fits well into these 

adulterated and substituted sections. We 

seek comment on whether providing 

authorization to the split laboratory 

would be sufficient, or should the DOT 

require them to forward the split 

specimen or portion of it. 

c. The NPRM would simplify the 

many possibilities for split specimen 

results by placing them into five distinct 

categories in § 40.187. One category 

contains MRO actions for split 

specimens that reconfirm all or some of 

the primary specimen results. Another 

contains MRO actions when the split 

fails to reconfirm all the primary 

specimen results because drugs were 

not detected and/or validity criteria 

were not met. The third category 

outlines MRO actions when the split 

fails to reconfirm all the primary 

specimen results and the split is 

reported as invalid, adulterated, and/or 

substituted. A fourth category details 

actions an MRO is to take when the split 

fails to confirm some but not all of the 

primary specimen results and the split 

is also reported as invalid, adulterated, 

and/or substituted. The final category 

delineates MRO responsibility when the 

split specimen is not available for 

testing or there is no split laboratory 

available to test the split specimen. 

d. The NPRM would modify § 40.187 

so that if a split fails to reconfirm all 

primary results but is reported as 

substituted, the MRO will be required to 

follow medical review procedures for 

substituted specimens and offer retest of 

the primary specimen if the MRO 

verifies the result as a refusal to test. 

This requirement is the same as the 

current part 40 procedures for MRO and 

laboratory actions after the split fails to 

Federal Register / Vol. 70, No. 209 / Monday, October 31, 2005 / Proposed Rules 62281 

reconfirm the primary results but is 

reported as adulterated. 

9. Recollections—In §§ 40.197 and 

40.201, we propose to change the 

regulation to clarify issues related to 

recollections for dilute specimens, for 

splits that are reported as invalid, and 

for a situation in which there is no split 

laboratory available to test the split 

specimen. 

10. Appendix Items—At Appendix B, 

we propose to modify the semi-annual 

laboratory report so that it will have the 

same information required by the HHS 

Mandatory Guidelines. The three 

proposed changes, while not dramatic, 

will help laboratories avoid needing two 

different report formats, one for DOT 

and one for HHS. We would also amend 

some Appendix F citations so that they 

will accurately reflect NPRM text 

changes. 

Other NPRM Issues and Questions 

1. MROs, TPAs, and collectors have 

asked the Department to clarify issues of 

multiple results reporting. Multiple 

results can be reported by laboratories 

because of several reasons. For instance, 

two collections (one unobserved, the 

other observed) occur during the same 

testing event because the first collection 

was out of temperature range or showed 

signs of tampering; a primary specimen 

had multiple test results; or a test result 

was one that required a subsequent 

collection. 

We believe the NPRM clearly 

delineates our proposals for MRO 

actions in multiple results situations 

and would like to have your comment 

about them. However, we also want to 

know your thoughts about the relative 

worth of continuing to have the 

collector send in two specimens (i.e., a 

temperature out of range specimen or 

one that showed signs of tampering and 

the subsequent observed specimen) 

instead of sending only the specimen 

collected under direct observation. 

Do the complications caused by 

linking (or failure to link) the two 

collections outweigh the possibility that 

the initial specimen will be nonnegative while the observed specimen 

will be negative or cancelled? What are 

some of the complications employers 

and MROs have experienced by having 

two different results on the two 

specimens for the same testing event? 

Can MROs report the verified results for 

two specimens for the same testing 

event on the same report? Do we simply 

need to make it clearer in part 40 that 

a non-negative result(s) for one 

specimen takes precedence over a 

negative or cancelled result for the other 

specimen? 

2. Invalid result rates have risen 

slightly and adulterated specimen rates 

decreased slightly since HHS required 

laboratories to utilize two separate SVT 

methodologies before they can report 

results as adulterated. If the laboratory 

identifies the possible presence of 

adulterant in a urine specimen using 

one testing methodology, they will call 

the specimen invalid. This does not 

apply to pH testing using a pH meter for 

both the initial and confirmation tests. 

Please provide us with your comments 

on the benefits of requiring all 

laboratories conducting DOT testing to 

utilize two methodologies for SVT 

(except pH) or for directing employers 

to use only laboratories that employ two 

methodologies. What will be the 

associated costs to laboratories and 

employers for requiring laboratories to 

utilize two methodologies? 

For invalid results, are required 

recollections under direct observation 

timely enough to identify drug use? 

Before laboratories report invalid 

results, are they contacting MROs (as 

required by the DOT and HHS) to 

discuss if sending the specimen to 

another HHS-certified laboratory will be 

useful? 

3. We propose no change to the 2004 

IFR in the treatment of negative-dilute 

specimens with creatinine in the 2–5 

mg/dL range as needing to be 

recollected under direct observation. 

The result of the second specimen will 

continue to be the result of record even 

if it is again negative-dilute. MROs have 

informed us that a number of the 

recollected observed specimens have 

produced positive results. Some of the 

reports we have received indicate that 

while some employees can normally 

produce specimens with creatinine in 

the 2–5 mg/dL range, others cannot 

achieve those results without tampering 

with their specimens. We are interested 

in your comments as to whether the 

DOT should continue to require 

recollection under direct observation for 

these negative-dilute results. 

Are the negative-dilute recollections 

under direct observation yielding results 

that show employee drug use? Given the 

threat to public safety, what percentage 

of positive results on these recollections 

would be considered too low to justify 

conducting them? 

4. Neither DOT nor HHS has required 

laboratories to report numerical values 

for creatinine and specific gravity for 

positive-dilute specimens, like we do 

for negative-dilute results. When MROs 

downgrade positive results to negative 

based upon legitimate medical reasons 

for these positive-dilute specimens, 

there is no additional MRO action 

because the dilute numerical values are 

not reported. Therefore, employers are 

not able to take the additional 

recollection actions afforded other 

negative-dilute specimen results. 

Should MROs have the same 

reporting responsibilities for 

downgraded negative-dilute results as 

they have for any other negative-dilute 

result? Should employers have the same 

responsibilities to recollect under direct 

observation when the creatinine 

concentration is in the 2–5 mg/dL range 

or the same recollection options if 

creatinine is above 5 mg/dL? 

5. Realistic-looking prosthetic devices 

which hold and heat urine (or water 

mixed with powdered urine) are 

available for purchase and are known to 

have been used during observed 

collections. They are available in a 

variety of colors making them difficult 

to detect. We are interested in your 

comments as to the appropriateness of 

having a collector make sure that the 

employee is not using a prosthetic 

device during an observed collection. 

For example, would it be appropriate 

to require that collectors and observers, 

as appropriate, check for these devices 

by having male employees lower their 

pants and underwear just before 

observed collections take place? What 

should be the consequence if a device 

is found? 

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 to further align our laboratory 

and MRO procedures with those 

requirements that are being directed by 

HHS. Their economic effects will be 

negligible. 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. 

In the 2000 part 40, we estimated that 

approximately 80% of industry 

specimens were being tested for SVT 

and that the costs associated with 

making SVT mandatory would be about 

$1.4 million annually. Current estimates 

are that 95% of industry specimens are 

already undergoing SVT on a voluntary 

basis. This higher percentage, coupled 

with the fact that fewer specimens are 

being collected now than were collected 

in 2000, leads us to believe the 

62282 Federal Register / Vol. 70, No. 209 / Monday, October 31, 2005 / Proposed Rules 

1The lower number of tests may result from two 

factors. First, the 2000 number was an estimate, 

while the 2005 number is based on actual reporting. 

It is possible that the 2000 number was on the high 

side. Second, the operating administrations believe 

that employment and turnover in some industries 

(e.g., the motor carrier industry) may have declined 

in recent years, resulting in fewer tests. 

incremental cost of SVT for those 

specimens not currently undergoing 

SVT will be even less than our 2000 cost 

estimate. There were 6.67 million 

industry tests conducted in 2005, down 

from 7 million industry tests in 2000.1

Therefore, we estimate that the annual 

cost of new SVT will be about $1 

million. 

Anyone is able to search the 

electronic form of all comments 

received into any of our dockets by the 

name of the individual submitting the 

comment (or signing the comment, if 

submitted on behalf of an association, 

business, labor union, etc.). You may 

review DOT’s complete Privacy Act 

Statement in the Federal Register 

published on April 11, 2000 (Volume 

65, Number 70; Pages 19477–78) or you 

may visit http://dms.dot.gov. 

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. 

Dated: October 21, 2005. 

Norman Y. Mineta, 

Secretary of Transportation. 

49 CFR Subtitle A—Authority and 

Issuance 

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 

1–2. 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. 

3. Section 40.3 is proposed to be 

amended by revising the definitions of 

‘‘adulterated specimen,’’ ‘‘confirmation 

(or confirmatory) drug test,’’

‘‘confirmation (or confirmatory) validity 

test,’’ ‘‘dilute specimen,’’ ‘‘initial drug 

test,’’ ‘‘initial validity test,’’ ‘‘invalid 

result,’’ and ‘‘substituted specimen’’ and 

adding definitions for ‘‘limit of 

detection,’’ ‘‘non-negative specimen,’’

‘‘oxidizing adulterant,’’ and ‘‘screening 

test’’ in alphabetical order, all to read as 

follows: 

§ 40.3 What do the terms in this regulation 

mean? 

* * * * * 

Adulterated specimen. A urine 

specimen containing a substance that is 

not a normal constituent or containing 

an endogenous substance at a 

concentration that is not a normal 

physiological concentration. 

* * * * * 

Confirmatory drug test. A second 

analytical procedure to identify the 

presence of a specific drug or metabolite 

which is independent of the initial test 

and which uses a different technique 

and chemical principle from that of the 

initial test in order to ensure reliability 

and accuracy. (Gas chromatography/ 

mass spectrometry (GC/MS) is the only 

authorized confirmation method for 

cocaine, marijuana, opiates, 

amphetamines, and phencyclidine). 

Confirmatory validity test. A second 

test performed on a different aliquot of 

the original urine specimen to further 

support a validity test result. 

* * * * * 

Dilute specimen. A urine specimen 

with creatinine and specific gravity 

values that are lower than expected for 

human urine. 

* * * * * 

Initial drug test (also known as a 

Screening drug test). An immunoassay 

test to eliminate ‘‘negative’’ urine 

specimens from further consideration 

and to identify the presumptively 

positive specimens that require 

confirmation or further testing. 

Initial validity test. The first test used 

to determine if a urine specimen is 

adulterated, diluted, or substituted. 

Invalid result. Refers to the result 

reported by a laboratory for a urine 

specimen that contains an unidentified 

adulterant, contains an unidentified 

interfering substance, has an abnormal 

physical characteristic, or has an 

endogenous substance at an abnormal 

concentration that prevents the 

laboratory from completing testing or 

obtaining a valid drug test result. 

* * * * * 

Limit of Detection (LOD). The lowest 

concentration at which an analyte can 

be reliably shown to be present under 

defined conditions. 

* * * * * 

Non-negative specimen. A urine 

specimen that is reported as adulterated, 

substituted, positive (for drug(s) or drug 

metabolite(s)), and/or invalid. 

* * * * * 

Oxidizing adulterant. A substance 

that acts alone or in combination with 

other substances to oxidize drugs or 

drug metabolites to prevent the 

detection of the drug or drug 

metabolites, or affects the reagents in 

either the initial or confirmatory drug 

test. Examples of these agents include, 

but are not limited to, nitrites, 

pyridinium chlorochromate, chromium 

(VI), bleach, iodine, halogens, 

peroxidase, and peroxide. 

* * * * * 

Screening drug test. See Initial drug 

test definition above. 

* * * * * 

Substituted specimen. A specimen 

with creatinine and specific gravity 

values that are so diminished or so 

divergent that they are not consistent 

with normal human urine. 

* * * * * 

4. Section 40.23 is proposed to be 

amended by revising paragraph (f) 

introductory text and adding paragraph 

(f)(5), to read as follows: 

§ 40.23 What actions do employers take 

after receiving verified test results? 

* * * * * 

(f) As an employer who receives a 

drug test result indicating that the 

employee’s specimen was cancelled 

because it was invalid and that a second 

collection must take place under direct 

observation—

* * * * * 

(5) You must ensure that the collector 

conducts the collection under direct 

observation. 

* * * * * 

5. Section 40.83 is proposed to be 

amended by revising paragraph (g)(2) to 

read as follows: 

§ 40.83 How do laboratories process 

incoming specimens? 

* * * * * 

(g) * * * 

(2) If the problem(s) is not corrected, 

you must reject the test and report the 

result in accordance with § 40.97(a)(3). 

* * * * * 

6–7. Section 40.89 is proposed to be 

amended by revising paragraph (b) to 

read as follows: 

§ 40.89 What is validity testing, and are 

laboratories required to conduct it? 

* * * * * 

(b) As a laboratory, you must conduct 

validity testing. 

8. Section 40.95 and its heading are 

proposed to be revised to read: 

§ 40.95 What are the adulterant cutoff 

concentrations for initial and confirmation 

tests? 

(a) As a laboratory, you must use the 

cutoff concentrations displayed in the 

following table for the initial and 

Federal Register / Vol. 70, No. 209 / Monday, October 31, 2005 / Proposed Rules 62283 

confirmation adulterant tests. The table 

follows: 

Adulterant test Initial test Confirmation test 

(1) pH ................................... Less than 3 or greater than 11 ....................................... Less than 3 or greater than 11. 

(2) Nitrite .............................. Greater than 500 mcg/mL ............................................... Greater than 500 mcg/mL. 

(3) Presence of Chromium 

(VI).

Greater than or equal to 50 mcg/mL .............................. Chromium (VI) concentration greater than or equal to 

the Level of Detection (LOD). 

(4) Presence of Halogen ...... Greater than or equal to 200 mcg/mL nitrite equivalent 

cutoff or 

Specific halogen concentration greater than or equal to 

the LOD. 

Greater than or equal to 50 mcg/mL Chromium (VI) 

equivalent cutoff or 

Halogen concentration greater than or equal to the 

LOD.

(5) Presence of 

Glutaraldehyde.

Aldehyde present or 

Characteristic immunoassay response on drug test ......

Glutaraldehyde concentration greater than or equal to 

the LOD. 

(6) Presence of Pyridine ...... Greater than or equal to 200 mcg/mL nitrite equivalent 

cutoff or 

Pyridine concentration greater than or equal to the 

LOD. 

Greater than or equal to 50 mcg/mL Chromium (VI) 

equivalent cutoff or 

Greater than or equal to 50 mcg/mL Chromium (VI) 

concentration.

(7) Presence of Surfactant 

(dodecylbenzene 

sulfonate-equivalent).

Greater than or equal to 100 mcg/mL ............................ Greater than or equal to 100 mcg/mL. 

(8) Presence of other 

adulterant.

Greater than or equal to the LOD ................................... Greater than or equal to the LOD. 

(b) As a laboratory, you must report 

results at or above the cutoffs (or for pH, 

at or above or below the values, as 

appropriate) as adulterated and provide 

the numerical values that support the 

adulterated result. 

9. A new § 40.96 is proposed to be 

added, to read as follows: 

§ 40.96 What criteria do laboratories use to 

establish that a specimen is invalid? 

(a) As a laboratory, you must use the 

invalid test result criteria displayed in 

the following table. The table follows: 

Invalid test category Initial test Confirmation test 

(1) Creatinine & Specific 

Gravity.

Creatinine less than 2 mg/dL and specific gravity is 

greater than 1.0010 but less than 1.0200 or 

Creatinine less than 2 mg/dL and specific gravity is 

greater than 1.0010 but less than 1.0200 

Specific gravity is less than or equal to 1.0010 and creatinine is greater than or equal to 2 mg/dL.Specific gravity is less than or equal to 1.0010 and creatinine is greater than or equal to 2 mg/dL. 

(2) pH ................................... Greater than or equal to 3 and less than 4.5 using a 

colorimetric pH test or pH meter or 

Greater than or equal to 3 and less than 4.5 using a pH 

meter. 

Greater than or equal to 9 and less than 11 using a 

colorimetric pH test or pH meter.

Greater than or equal to 9 and less than 11 using a pH 

meter. 

(3) Nitrite .............................. Greater than or equal to 200 mcg/mL using a nitrite colorimetric test or Greater than or equal to 200 mcg/mL but less than 500 

mcg/ml using a different confirmatory test. 

Greater than or equal to the equivalent of 200 mcg/mL 

nitrite using a general oxidant colorimetric test or 

Greater than or equal to 200 mcg/mL but less than 500 

mcg/mL using the same general oxidant colorimetric 

test. 

Greater than or equal to the equivalent of 200 mcg/mL 

using a general oxidant colorimetric test.

Greater than or equal to 200 mcg/mL but less than 500 

mcg/ml using a different confirmatory test. 

(4) Chromium (VI) ................ Greater than or equal to 50 mcg/mL using a chromium 

(VI) colorimetric test.

Greater than or equal to 50 mcg/mL using the same 

chromium (VI) colorimetric test. 

(5) Halogen .......................... Greater than or equal to the LOD using a hologen colorimetric test or Greater than or equal to the LOD using the same halogen test colorimetric test. 

Odor of the specimen ..................................................... Greater than or equal to the LOD using a halogen colorimetric test. 

(6) Glutaraldehyde ............... Aldehyde present using an aldehyde test or Aldehyde present using the same aldehyde test. 

Characteristic immunoassay response on initial drug 

test.

Characteristic immunoassay response on confirmatory 

drug test. 

(7) Oxidizing Adulterant ....... Greater than or equal to 200 mcg/mL nitrite-equivalent 

using a general oxidant colorimetric test or 

Greater than or equal to 200 mcg/mL nitrite-equivalent 

using the same general oxidant colorimetric test. 

Greater than or equal to 50 mcg/mL chromium (VI)- 

equivalent using a general oxidant colorimetric test or 

Greater than or equal to 50 mcg/mL chromium (VI)- 

equivalent using the same general oxidant colorimetric test. 

Greater than or equal to the LOD halogen concentration using a general oxidant colorimetric test.Greater than or equal to the LOD halogen concentration using the same general oxidant colorimetric test. 

(8) Surfactant ....................... Greater than or equal to 100 mcg/ml dodecylbenzene 

sulfonate-equivalent using a surfactant colorimetric 

test or 

Greater than or equal to 100 mcg/ml dodecylbenzene 

sulfonate-equivalent using a the same surfactant colorimetric test. 

62284 Federal Register / Vol. 70, No. 209 / Monday, October 31, 2005 / Proposed Rules 

Invalid test category Initial test Confirmation test 

Foam/shake test .............................................................. Greater than or equal to 100 mcg/ml dodecylbenzene

sulfonate-equivalent using a surfactant colorimetric 

test. 

(9) Interference on 

immunoassay drug tests.

Valid drug test cannot be obtained ................................. Valid drug test cannot be obtained. 

(10) Interference with the 

GC/MS drug confirmation 

assay.

No interfering substance can be identified ..................... No interfering substance can be identified. 

(11) Physical appearance of 

the specimen is such that 

it may damage laboratory 

equipment..

(12) Physical appearance of 

Bottles A and B are clearly different and Bottle A 

result is as stated in 1 

through 11, as appropriate, on this table..

(b) To obtain one of the invalid results 

outlined at 1 through 10 of this table, as 

a laboratory, you must use two separate 

aliquots—one for the initial test and 

another for the confirmation test. 

(c) For a specimen having an invalid 

result for one of the reasons outlined at 

4 through 12 of this table, as a 

laboratory, you must contact the MRO to 

discuss whether sending the specimen 

to another HHS certified laboratory for 

testing would be useful in being able to 

report a positive or adulterated result. 

(d) As a laboratory, you must report 

the reason a test result is invalid. 

10. Section 40.97 is proposed to be 

amended by adding the words, ‘‘and 

Rejected for Testing’’ between ‘‘Nonnegative’’ and ‘‘results’’ at paragraph 

(b)(2) and by revising paragraph (a) to 

read as follows: 

§ 40.97 What do laboratories report and 

how do they report it? 

(a) As a laboratory, you must report 

the results for each primary specimen. 

The result of a primary specimen will 

fall into one of three categories. They 

are as follows: 

(1) Category 1: Negative Results. 

When a specimen is found to be 

negative, as a laboratory, you must 

report the test result as being one of the 

following, as appropriate: 

(i) Negative, or 

(ii) Negative-dilute, with numerical 

values for creatinine and specific 

gravity. 

(2) Category 2: Non-negative Results. 

When a specimen is found to be nonnegative, as a laboratory, you must 

report the test result as being one or 

more of the following, as appropriate: 

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

noted; 

(ii) Positive-dilute, with drug(s)/ 

metabolite(s) noted, with numerical 

values for creatinine and specific 

gravity; 

(iii) Adulterated, with adulterant(s) 

noted, with numerical values (when 

applicable), and with remarks(s); 

(iv) Substituted, with numerical 

values for creatinine and specific 

gravity; or 

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

(3) Category 3: Rejected for Testing. 

When a specimen is rejected for testing, 

as a laboratory you must report the 

result as being Rejected for Testing, with 

remark(s). 

* * * * * 

11. Section 40.103 is proposed to be 

amended by removing the word ‘‘blank’’

and adding in its place the word 

‘‘negative’’ in paragraph (c) introductory 

text, by revising paragraphs (c)(1) 

through (5), and removing paragraphs 

(c)(6) to read as follows: 

§ 40.103 What are the requirements for 

submitting blind specimens to a 

laboratory? 

* * * * * 

(c) * * * 

(1) All negative, positive, adulterated, 

and substituted blind specimens you 

submit must be certified by the supplier 

and must have supplier-provided 

expiration dates. 

(2) Negative specimens must be 

certified by immunoassay and GC/MS to 

contain no drugs. 

(3) Drug positive blind specimens 

must be certified by immunoassay and 

GC/MS to contain a drug(s)/ 

metabolite(s) between 1.5 and 2 times 

the initial drug test cutoff concentration. 

(4) Adulterated blind specimens must 

be certified to be adulterated with a 

specific adulterant using appropriate 

confirmatory validity test(s). 

(5) Substituted blind specimens must 

be certified for creatinine concentration 

and specific gravity to satisfy the criteria 

for a substituted specimen using 

confirmatory creatinine and specific 

gravity tests, respectively. 

* * * * * 

§ 40.105 [Amended] 

12. Section 40.105 is proposed to be 

amended by adding in paragraph (c) the 

words ‘‘adulterated, or substituted 

result’’ after the word ‘‘positive,’’ and 

before the word ‘‘you’. 

13. Section 40.129 is proposed to be 

amended by revising the section 

heading and paragraph (a)(5) to read as 

follows: 

§ 40.129 What are the MRO’s functions in 

reviewing laboratory confirmed nonnegative drug test results? 

(a) * * * 

(5) Verify the test result, consistent 

with the requirements of §§ 40.135–

40.145, 40.159, and 40.160, as: 

(i) Negative; or 

(ii) Cancelled; or 

(iii) Positive, and/or refusal to test 

because of adulteration or substitution. 

* * * * * 

14. Section 40.131 is proposed to be 

amended by revising the section 

heading to read as follows: 

§ 40.131 How does the MRO or DER notify 

an employee of the verification process 

after laboratory confirmed non-negative 

drug test results? 

* * * * * 

15. Section 40.133 is proposed to be 

amended by revising the section 

heading, redesignating paragraphs (b) 

and (c) as (c) and (d), respectively, 

revising them, and adding paragraph (b) 

to read as follows: 

§ 40.133 Under what circumstances may 

the MRO verify a test result as positive, or 

as a refusal to test because of adulteration 

or substitution, or as cancelled-invalid, 

without interviewing the employee? 

* * * * * 

Federal Register / Vol. 70, No. 209 / Monday, October 31, 2005 / Proposed Rules 62285 

(b) As the MRO, you may verify a test 

result as cancelled-invalid (with 

instructions to recollect immediately 

under direct observation) without 

interviewing the employee, as provided 

at § 40.159, if: 

(1) The employee expressly declines 

the opportunity to discuss the test with 

you; 

(2) If the DER has successfully made 

and documented a contact with the 

employee and instructed the employee 

to contact you and more than 72 hours 

have passed since the time the DER 

contacted the employee; or 

(3) If neither you nor the DER, after 

making all reasonable efforts, has been 

able to contact the employee within ten 

days of the date on which you received 

the confirmed invalid test result from 

the laboratory. 

(c) As the MRO, after you verify a test 

result as a positive or refusal to test or 

as a cancelled-invalid result under this 

section, you must document the date 

and time and reason, following the 

instructions in § 40.163, and, for a 

cancelled-invalid result, at 

§ 40.159(a)(5)(i). 

(d) As the MRO, after you have 

verified a test result under this section 

and reported the result to the DER, you 

must allow the employee to present 

information to you within 60 days of the 

verification documenting that serious 

illness, injury, or other circumstances 

unavoidably precluded contact with the 

MRO and/or DER in the times provided. 

On the basis of such information, you 

may reopen the verification, allowing 

the employee to present information 

concerning whether there is a legitimate 

medical explanation of the confirmed 

test result. 

16. Section 40.149 is proposed to be 

amended by revising the section 

heading, removing the words ‘‘positive 

or refusal to test’’ in paragraph (a), and 

removing, in paragraph (a)(1), the 

reference to ‘‘§ 40.133(c)’’ and adding in 

its place ‘‘§ 40.133(d)’’ to read as 

follows: 

§ 40.149 May the MRO change a verified 

drug test result? 

* * * * * 

17. Section 40.155 is proposed to be 

amended by adding paragraph (d) to 

read as follows: 

§ 40.155 What does the MRO do when a 

negative or positive test result is also 

dilute? 

* * * * * 

(d) If the employee’s recollection 

under direct observation, in paragraph 

(c) of this section, results in another 

negative-dilute, as the MRO, you must: 

(1) Obtain verification from the 

collector that the recollection was 

directly observed. 

(2) If the recollection was directly 

observed, report this result to the DER 

as a negative-dilute result. 

(3) If the recollection was not directly 

observed as required, do not report a 

result but again explain to the DER that 

there must be an immediate recollection 

under direct observation. 

18. Section 40.159 is proposed to be 

amended by revising paragraphs (a)(1) 

through (3), adding paragraphs 

(a)(4)(iii), and (d) through (f) to read as 

follows: 

§ 40.159 What does the MRO do when a 

drug test is invalid? 

(a) * * * 

(1) Discuss the laboratory results with 

the certifying scientist to determine if 

the primary specimen should be tested 

at another HHS certified laboratory. If 

the laboratory did not carried out its 

requirements to contact you at 

§§ 40.91(e) and 40.96(c), you must 

contact the laboratory. 

(2) If you and the laboratory have 

determined that no further testing is 

necessary, contact the employee and 

inform the employee that the specimen 

was invalid. In contacting the employee, 

use the procedures set forth in § 40.131. 

(3) After explaining the limits of 

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

you must determine if the employee has 

a medical explanation for the invalid 

result. You should inquire about the 

medications the employee may have 

taken. 

(4) * * * 

(iii) If a negative test result is required 

and the medical explanation concerns a 

situation in which the employee has a 

permanent or long-term physiological or 

anatomic abnormality that precludes 

him or her from providing a valid 

specimen, as the MRO, you must follow 

the procedures outlined at § 40.160 for 

determining if there is clinical evidence 

that the individual is an illicit drug 

user. 

* * * * * 

(d) If the employee’s recollection 

(required at paragraph (a)(5) of this 

section) results in another invalid result 

for the same reason reported for the first 

specimen, as the MRO, you must: 

(1) Obtain verification from the 

collector that the recollection was 

directly observed. 

(2) If the recollection was directly 

observed, document that the employee 

had another specimen with an invalid 

result. 

(3) Follow the recording and reporting 

procedures at (a)(4)(i) and (ii) of this 

section. 

(4) If a negative result is required (i.e., 

pre-employment, return-to-duty, or 

follow-up tests), follow the procedures 

at § 40.160 for determining if there is 

clinical evidence that the individual is 

an illicit drug user. 

(5) If the recollection was not directly 

observed as required, do not report a 

result but again explain to the DER that 

there must be an immediate recollection 

under direct observation. 

(e) If the employee’s recollection 

(required at paragraph (a)(5) of this 

section) results in another invalid result 

for a different reason reported for the 

first specimen, as the MRO, you must 

report the test result as being a refusal. 

(f) If, as the MRO, you receive a 

laboratory invalid result in conjunction 

with a positive, adulterated, and/or 

substituted result and you verify any of 

those results as being a positive and/or 

refusal to test, you do not report the 

cancelled-invalid result unless the split 

specimen fails to reconfirm the result(s) 

of the primary specimen. 

19. Section 40.160 is proposed to be 

added to read as follows: 

§ 40.160 What does the MRO do when a 

valid test result cannot be produced and a 

negative result is required? 

(a) If a valid test result cannot be 

produced and a negative result is 

required, (under § 40.159 (a)(4)(iii) and 

(d)(4)), as the MRO, you must determine 

if there is clinical evidence that the 

individual is an illicit drug user. You 

must make this determination by 

personally conducting, or causing to be 

conducted, a medical evaluation and 

through consultation with the 

employee’s physician (if appropriate). 

(b) If you do not personally conduct 

the medical evaluation, as the MRO, you 

must ensure that one is conducted by a 

licensed physician acceptable to you. 

(c) For purposes of this section, the 

MRO or the physician conducting the 

evaluation may conduct an alternative 

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

appropriate procedures in determining 

clinical evidence of drug use. 

(d) If the medical evaluation reveals 

no clinical evidence of drug use, as the 

MRO, you must report the result to the 

employer as a negative test with written 

notations regarding the medical 

examination. The report must also state 

why the medical examination was 

required (i.e., either the basis for the 

determination that a permanent or longterm medical condition exists or 

because the recollection under direct 

observation resulted another invalid 

result for the same reason, as 

appropriate) and for the determination 

that no signs and symptoms of drug use 

exist. 

62286 Federal Register / Vol. 70, No. 209 / Monday, October 31, 2005 / Proposed Rules 

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

CCF. 

(2) Sign and date the CCF. 

(e) If the medical evaluation reveals 

clinical evidence of drug use, as the 

MRO, you must report the result to the 

employer as a cancelled test with 

written notations regarding results of 

the medical examination. The report 

must also state why the medical 

examination was required (i.e., either 

the basis for the determination that a 

permanent or long-term medical 

condition exists or because the 

recollection under direct observation 

resulted another invalid result for the 

same reason, as appropriate) and for the 

determination that signs and symptoms 

of drug use exist. Because this is a 

cancelled test, it does not serve the 

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

employer is not authorized to allow the 

employee to begin or resume performing 

safety-sensitive functions, because a 

negative test is needed for that purpose). 

20. Section 40.162 is proposed to be 

added to read as follows: 

§ 40.162 What must MROs do with multiple 

verified results for the same testing event? 

(a) If the testing event is one in which 

there was one specimen collection with 

multiple verified non-negative results, 

as the MRO, you must report them all 

to the DER. For example, if you verified 

the specimen as being positive for 

marijuana and cocaine and as being a 

refusal to test because the specimen was 

also adulterated, as the MRO, you 

would report the positives and the 

refusal to the DER. 

(b) If the testing event was one in 

which two separate specimen 

collections (e.g., a specimen out of 

temperature range and the subsequent 

observed collection) were sent to the 

laboratory, as the MRO, you must: 

(1) If both specimens were verified 

negative, report the result as negative. 

(2) If either of the specimens was 

verified negative and the other was 

verified non-negative(s), report the nonnegative result(s). For example, if you 

verified one specimen as negative and 

other as a refusal to test because the 

specimen was substituted, as the MRO 

you would report the only the refusal to 

the DER. 

(3) If both specimens were verified 

non-negative, report all of the nonnegative results. For example, if you 

verified one specimen as positive and 

the other as a refusal to test because the 

specimen was adulterated, as the MRO 

you would report the positive and the 

refusal results to the DER. 

(c) As an exception to paragraphs (a) 

and (b) of this section, as the MRO you 

must follow procedures at 

§ 40.159(f)when any verified nonnegative result is also invalid. 

21. Section 40.171 is proposed to be 

amended by revising paragraph (a) to 

read as follows: 

§ 40.171 How does an employee request a 

test of a split specimen? 

(a) As an employee, when the MRO 

has notified you that you have a verified 

positive drug test and/or refusal to test 

because of adulteration or substitution, 

you have 72 hours from the time of 

notification to request a test of the split 

specimen. The request may be verbal or 

in writing. If you make this request to 

the MRO within 72 hours, you trigger 

the requirements of this section for a 

test of the split specimen. There is no 

split specimen testing for an invalid 

result. 

* * * * * 

22. Section 40.177 is proposed to be 

amended by revising paragraph (d) to 

read as follows: 

§ 40.177 What does the second laboratory 

do with the split specimen when it is tested 

to reconfirm the presence of a drug or drug 

metabolite? 

* * * * * 

(d) In addition, if the test fails to 

reconfirm the presence of the drug(s)/ 

drug metabolite(s) that were reported in 

the primary specimen, you may transmit 

the specimen or an aliquot of it for 

testing at another HHS-certified 

laboratory that has the capability to 

conduct another reconfirmation test. 

23. Section 40.179 is proposed to be 

amended by revising the section to read 

as follows: 

§ 40.179 What does the second laboratory 

do with the split specimen when it is tested 

to reconfirm an adulterated test result? 

(a) As the laboratory testing the split 

specimen, you must test the split 

specimen for the adulterant detected in 

the primary specimen, using the criteria 

of § 40.95, just as you would do for a 

primary specimen. 

(b) In addition, if the test fails to 

reconfirm validity criteria reported in 

the primary specimen, you may transmit 

the specimen or an aliquot of it for 

testing at another HHS-certified 

laboratory that has the capability to 

conduct another reconfirmation test. 

24. Section 40.181 is proposed to be 

amended by revising the section to read 

as follows: 

§ 40.181 What does the second laboratory 

do with the split specimen when it is tested 

to reconfirm a substituted test result? 

(a) As the laboratory testing the split 

specimen, you must test the split 

specimen using the criteria of § 40.93(b), 

just as you would do for a primary 

specimen. 

(b) In addition, if the test fails to 

reconfirm validity criteria reported in 

the primary specimen, you may transmit 

the specimen or an aliquot of it for 

testing at another HHS-certified 

laboratory that has the capability to 

conduct another reconfirmation test. 

25. Section 40.183 is proposed to be 

amended by revising paragraph (a), 

removing paragraph (b), and redesignating paragraph (c) as paragraph 

(b), to be read as follows: 

§ 40.183 What information do laboratories 

report to MROs regarding split specimen 

results? 

(a) As the laboratory responsible for 

testing the split specimen, you must 

report split specimen test results by 

checking the ‘‘Reconfirmed’’ box and/or 

the ‘‘Failed to Reconfirm’’ box (Step 

5(b)) on Copy 1 of the CCF, as 

appropriate, and by providing clarifying 

remarks using current HHS Mandatory 

Guidelines requirements. 

* * * * * 

26. Section 40.187 is proposed to be 

amended by revising the section to read 

as follows: 

§ 40.187 What does the MRO do with split 

specimen laboratory results? 

As the MRO, the split specimen 

laboratory results you receive will fall 

into five categories. You must take the 

following action, as appropriate, when a 

laboratory reports split specimen results 

to you. 

(a) Category 1: The laboratory 

reconfirmed all or some of the primary 

specimen results. 

(1) As the MRO, you must report to 

the DER and employee which result(s) 

was/were reconfirmed. 

(2) In the case of a reconfirmed 

positive test(s) for drug(s) or drug 

metabolite(s), the positive is the final 

result. 

(3) In the case of a reconfirmed 

adulterated or substituted result, the 

refusal to test is the final result. 

(4) In the case of combination positive 

and refusal to test results, the final 

result is both positive and refusal to test. 

(b) Category 2: The laboratory failed to 

reconfirm all of the primary specimen 

results because, as appropriate, drug(s)/ 

drug metabolite(s) were not detected; 

adulteration criteria were not met; and/ 

or substitution criteria were not met. 

(1) As the MRO, you must report to 

the DER and the employee that the test 

must be cancelled. 

(2) As the MRO, you must inform 

ODAPC of the failure to reconfirm using 

the format in Appendix D to this part. 

(3) In a case where the split failed to 

reconfirm because the substitution 

Federal Register / Vol. 70, No. 209 / Monday, October 31, 2005 / Proposed Rules 62287 

criteria were not met because the split 

specimen creatinine concentration was 

greater than 2mg/dL but less than or 

equal to 5mg/dL, as the MRO, you must, 

in addition to steps at (b)(1) and (2) of 

this paragraph, direct the DER to ensure 

the immediate collection of another 

specimen from the employee under 

direct observation, with no notice given 

to the employee of this collection 

requirement until immediately before 

the collection. 

(c) Category 3: The laboratory failed to 

reconfirm all of the primary specimen 

results, and also reported that the split 

specimen was invalid, adulterated, and/ 

or substituted. 

(1) In the case where the laboratory 

failed to reconfirm all of the primary 

specimen results and the split was 

reported as invalid, as the MRO, you 

must: 

(i) Report to the DER and the 

employee that the test must be cancelled 

and the reason for cancellation. 

(ii) Direct the DER to ensure the 

immediate collection of another 

specimen from the employee under 

direct observation, with no notice given 

to the employee of this collection 

requirement until immediately before 

the collection. 

(iii) Inform ODAPC of the failure to 

reconfirm using the format in Appendix 

D to this part. 

(2) In the case where the laboratory 

failed to reconfirm any of the primary 

specimen results, and the split was 

reported as adulterated and/or 

substituted, as the MRO, you must: 

(i) Contact the employee and inform 

the employee that the laboratory has 

determined that his or her split 

specimen is adulterated and/or 

substituted, as appropriate. 

(ii) Follow the procedures of § 40.145 

to determine if there is a legitimate 

medical explanation for the laboratory 

finding of adulteration and/or 

substitution, as appropriate. 

(iii) If you determine that there is a 

legitimate medical explanation for the 

adulterated and/or substituted test 

result, report to the DER and the 

employee that the test must be 

cancelled; and inform ODAPC of the 

failure to reconfirm using the format in 

Appendix D to this part. 

(iv) If you determine that there is not 

a legitimate medical explanation for the 

adulterated and/or substituted test 

result, take the following steps: 

(A) Report the test to the DER and the 

employee as a verified refusal to test. 

Inform the employee that he or she has 

72 hours to request a test of the primary 

specimen to determine if the adulterant 

found in the split specimen also is 

present in the primary specimen and/or 

to determine if the primary specimen 

meets appropriate substitution criteria. 

(B) Except that the request is for a test 

of the primary specimen and is being 

made to the laboratory that tested the 

primary specimen, follow the 

procedures of §§ 40.153, 40.171, 40.173, 

40.179, 40.181, and 40.185, as 

appropriate. 

(C) As the laboratory that tests the 

primary specimen to reconfirm the 

presence of the adulterant found in the 

split specimen and/or determine that 

the primary specimen meets appropriate 

substitution criteria, report your result 

to the MRO on a photocopy (faxed, 

mailed, scanned, couriered) of Copy 1 of 

the CCF. 

(D) If the test of the primary specimen 

reconfirms the adulteration and/or 

substitution finding of the split 

specimen, as the MRO you must report 

the result as a refusal to test as provided 

in paragraph (a)(3) of this section. 

(E) If the test of the primary specimen 

fails to reconfirm the adulteration and/ 

or substitution finding of the split 

specimen, as the MRO you must cancel 

the test, following procedures in 

paragraph (b) of this section. 

(d) Category 4: The laboratory failed 

to reconfirm some but not all of the 

primary specimen results, and also 

reported that the split specimen was 

invalid, adulterated, and/or substituted. 

(1) In the case where the laboratory 

reconfirmed one or more of the primary 

specimen result(s), as the MRO, you 

must follow procedures in paragraph (a) 

of this section and: 

(2) Report that the split was reported 

also as being invalid, adulterated, and/ 

or substituted (as appropriate). 

(3) Inform the DER to take action only 

on the reconfirmed result(s). 

(e) Category 5: The split specimen was 

not available for testing or there was no 

split laboratory available to test the 

specimen. 

(1) As the MRO, you must report to 

the DER and the employee that the test 

must be cancelled and the reason for the 

cancellation. 

(2) As the MRO, you must also direct 

the DER to ensure the immediate 

recollection of another specimen from 

the employee under direct observation, 

with no notice given to the employee of 

this collection requirement until 

immediately before the collection. 

(3) As the MRO, you must notify 

ODACP of the failure to reconfirm using 

the format in Appendix D to this part. 

(f) For all split specimen results, as 

the MRO you must: 

(1) Enter your name, sign and date 

(Step 7) of Copy 2 of the CCF. 

(2) Send a legible copy of Copy 2 of 

the CCF (or a signed and dated letter, 

see § 40.163) to the employer and keep 

a copy for your records. Transmit the 

document as provided in § 40.167. 

27. Section 40.191 is proposed to be 

amended by redesignating paragraphs 

(c) through (e) as (d) through (f), 

respectively, and adding paragraph (c) 

to read as follows: 

§ 40.191 What is a refusal to take a DOT 

drug test, and what are the consequences? 

* * * * * 

(c) As an employee, if you have a 

recollection under direct observation 

because of an invalid test result and the 

MRO reports the result of the observed 

specimen as being invalid for a different 

reason than the first specimen, you have 

refused to take a drug test. 

* * * * * 

28. Section 40.197 is proposed to be 

amended by revising paragraph (c)(3), 

redesignating paragraph (c)(4) as (c)(5), 

and adding paragraph (c)(4) to read as 

follows: 

§ 40.197 What happens when an employer 

receives a report of a dilute specimen? 

* * * * * 

(c) * * * 

(3) If the result of the test you directed 

the employee to take under paragraph 

(b)(1) of this section is also negative and 

dilute, you are not permitted to make 

the employee take an additional test 

because the result was dilute. 

(4) If the result of the test you directed 

the employee to take under paragraph 

(b)(2) of this section is also negative and 

dilute, you are not permitted to make 

the employee take an additional test 

because the result was dilute. Provided, 

however, that if the MRO directs you to 

conduct a recollection under direct 

observation under paragraph (b)(1) of 

this section, you must immediately do 

so. 

* * * * * 

29. Section 40.201 is proposed to be 

amended by revising paragraphs (c), (d), 

and (e) to read as follows: 

§ 40.201 What problems always cause a 

drug test to be cancelled and may result in 

a requirement for another collection? 

* * * * * 

(c) The split specimen failed to 

reconfirm all of the primary specimen 

results because drug(s)/drug 

metabolite(s) were not detected; 

adulteration criteria were not met; and/ 

or substitution criteria were not met. 

You must follow the applicable 

procedures in 40.187(b) (no recollection 

is required in this case, unless the 

specimen creatinine concentration for a 

substituted specimen was greater than 

2mg/dL but less than or equal to 5mg/ 

dL—which requires recollection under 

direct observation). 

62288 Federal Register / Vol. 70, No. 209 / Monday, October 31, 2005 / Proposed Rules 

(d) The split specimen failed to 

reconfirm all of the primary specimen 

results, and reported that the split 

specimen was invalid. You must follow 

the procedures in 40.187(c)(1) 

(recollection under direct observation is 

required in this case). 

(e) The split specimen failed to 

reconfirm all of the primary specimen 

results because the split specimen was 

not available for testing or there was no 

split laboratory available to test the 

specimen. You must follow applicable 

procedures in 40.187(e) (recollection 

under direct observation is required in 

this case). 

* * * * * 

§ 40.207 [Amended] 

30. Section 40.207 is proposed to be 

amended by removing, in paragraph 

(a)(3), the reference to ‘‘40.187(b)’’ and 

adding in its place ‘‘40.187(b)(3), (c)(1), 

and (e)’’. 

31. Appendix B to Part 40 is proposed 

to be amended by revising it to read as 

follows: 

Appendix B to Part 40—DOT Drug 

Testing Semi-Annual Laboratory 

Report 

The summary report shall contain the 

following information: 

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 Type of Test 

(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) 

5. Adulterated (number) 

6. Substituted (number) 

7. Invalid Result (number) 

Appendix F to Part 40—[Amended] 

32. Appendix F to Part 40 is proposed 

to be amended by removing the 

references to § 40.187(a)–(f) and 

§ 40.191(d) and adding in their place 

§ 40.187(a)–(e) and § 40.191(e), 

respectively. 

[FR Doc. 05–21488 Filed 10–28–05; 8:45 am] 

BILLING CODE 4910–62–P 

DEPARTMENT OF TRANSPORTATION 

Office of the Secretary 

49 CFR Part 71 

[OST Docket No. 2005–22114] 

RIN 2105–AD53 

Standard Time Zone Boundary in the 

State of Indiana 

AGENCY: Office of the Secretary (OST), 

Department of Transportation (DOT). 

ACTION: Notice of proposed rulemaking. 

SUMMARY: DOT tentatively proposes to 

relocate the time zone boundary in 

Indiana to move St. Joseph, Starke, 

Knox, Pike, and Perry Counties from the 

eastern time zone to the central time 

zone at the request of the County 

Commissioners. We are tentatively not 

proposing to change the time zone 

boundary to move Marshall, Pulaski, 

Fulton, Benton, White, Carroll, Cass, 

Vermillion, Sullivan, Daviess, Dubois, 

Martin, and Lawrence Counties from the 

eastern time zone to the central time 

zone based on the petitions from the 

commissioners in these counties. If 

additional information is provided that 

indicates that the time zone boundary 

should be drawn differently, either to 

include counties currently excluded or 

to exclude counties that are currently 

included in this proposal, we will make 

the change at the final rule stage of this 

proceeding. 

DATES: Any County Commissioners from 

the counties that have submitted 

petitions who wish to provide 

additional data to justify a change from 

the eastern time zone to the central time 

zone should do so by November 10, 

2005. Other comments should be 

received by November 30, 2005 to be 

assured of consideration. Comments 

received after that date will be 

considered to the extent practicable. If 

the time zone boundary is changed as a 

result of this rulemaking, the effective 

date would be no earlier than 2 a.m. 

EST Sunday, April 2, 2006, which is the 

changeover from standard time to 

daylight saving time. 

ADDRESSES: You may submit comments 

by any of the following methods: 

• Web Site: http://dms.dot.gov. 

Follow the instructions for submitting 

comments on the DOT electronic docket 

site. 

• Fax: 1–202–493–2251. 

• Mail: Docket Management Facility; 

U.S. Department of Transportation, 400 

Seventh Street, SW., Nassif Building, 

Room PL–401, Washington, DC 20590–

001. 

• Hand Delivery: Room PL–401 on 

the plaza level of the Nassif Building, 

400 Seventh Street, SW., Washington, 

DC, between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal 

Holidays. 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov. Follow the 

online instructions for submitting 

comments. 

Instructions: All submissions must 

include the agency name and docket 

number (OST Docket Number 2005–

22114) or Regulatory Identification 

Number (RIN) (2105–AD53) for this 

rulemaking. Note that all comments 

received will be posted without change 

to http://dms.dot.gov including any 

personal information provided. Please 

see the Privacy Act heading under 

Regulatory Notices. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

dms.dot.gov at any time or to Room PL–

401 on the plaza level of the Nassif 

Building, 400 Seventh Street, SW., 

Washington, DC, between 9 a.m. and 5 

p.m., Monday through Friday, except 

Federal Holidays. 

Public Hearings: In addition to the 

submission of written comments, an 

opportunity for oral comments will be 

provided at four public hearings in 

Jasper, Logansport, South Bend, and 

Terre Haute. These hearings will be 

chaired by a representative of DOT in 

November. We will publish the date and 

time in a separate document that will be 

posted in the docket and published in 

the Federal Register. 

The hearings will be informal and 

will be tape-recorded for inclusion in 

the docket. The DOT representative will 

provide an opportunity to speak for all 

those wishing to do so, to the greatest 

extent possible. The hearing locations 

will be accessible for persons with 

disabilities. If you need a sign language 

interpreter, please let us know no later 

than one week before the hearing. 

FOR FURTHER INFORMATION CONTACT: 

Joanne Petrie, Office of the Assistant 

General Counsel for Regulation and 

Enforcement, U.S. Department of 

Transportation, Room 10424, 400