Procedures for Transportation Workplace Drug and Alcohol Testing Programs; Final Rule DEPARTMENT OF TRANSPORTATION

SUMMARY: The Department of Transportation is making a series of minor

or technical amendments to its drug and alcohol testing procedures. The

most significant of these include revising the initial test cutoff

level for marijuana metabolites, changing split specimen collection

procedures to be consistent with those of the Department of Health and

Human Services, revising the temperature range for urine drug

specimens, revising the drug testing custody and control form and

modifying the alcohol testing form, clarifying laboratory reporting

procedures to consortiums, deleting a requirement for a second ``air

blank'' after alcohol confirmation tests, specifying procedures related

to the display of the sequential number for alcohol tests, and

clarifying chain of custody requirements. The changes have the purposes

of updating the procedures to be consistent with Department of Health

and Human Services guidelines and addressing implementation problems of

which the Department has become aware.

DATES: This rule is effective September 19, 1994, with the following

exceptions:

(1) The amendments to Sec. 40.23(a) are effective February 16,

1995, but compliance with these amendments is authorized on August 19,

1994;

(2) The amendments to Secs. 40.25(f)(10)(ii) (B) and (C) and

40.29(b)(1) are effective August 15, 1994;

(3) The amendments to Sec. 40.29 (e) and (f) are effective

September 1, 1994; and

(4) The amendments to Sec. 40.25 (c) and (h) are effective on

August 19, 1994. Comments should be received by September 19, 1994,

except that comments on the amendment to Sec. 40.23 should be received

by October 18, 1994. Late-filed comments will be considered to the

extent practicable.

FOR FURTHER INFORMATION CONTACT: Robert C. Ashby, Deputy Assistant

General Counsel for Regulation and Enforcement, 400 7th Street, S.W.,

Room 10424. 202-366-9306. Information may also be obtained from the

Office of Drug Enforcement and Program Compliance, 202-366-3784.

SUPPLEMENTARY INFORMATION: The Department is publishing this final rule

to make several minor or technical amendments to its drug and alcohol

testing procedures, 49 CFR Part 40. The changes to Part 40 are

described below. The changes are intended, among other things, to

conform Part 40 to a number of provisions in the recently revised

Department of Health and Human Services (DHHS) guidelines (59 FR 29908;

June 9, 1994) and to correct a misinterpretation of the Department's

chain of custody requirements. The Department is seeking comments on

these amendments and will publish a notice in the Federal Register

responding to comments received including, if appropriate, any changes

to the amendments based on the comments.

The Drug Testing Custody and Control Form

As the result of a lengthy process of consultation among the

Department of Transportation, the Department of Health and Human

Services (DHHS), and other interested parties, the Department has made

modifications to the drug testing custody and control form. This form

will be used in Federal employee testing as well as testing under DOT

rules. The form is reproduced in Appendix A. OMB has approved the form

under the Paperwork Reduction Act.

Under the current rule, program participants have had the

discretion to modify the drug testing custody and control form, as long

as the contents of the form met the requirements of the regulatory text

describing the form in Sec. 40.23(a). In the Department's experience,

this has led to a proliferation of different forms, with consequent

confusion and increased probability of error. In the alcohol testing

procedures, we required employers to use the Department's alcohol

testing form without modification. Now that we have an improved drug

testing custody and control form, we believe that it should be used

universally in the program, without exception and without modification.

For this reason, we are amending Sec. 40.23 to delete the regulatory

text description of the form (which is no longer needed, since everyone

would be using exactly the form printed in Appendix A) and to require

participants in the program to use the Department's form without

modification.

We recognize that participants have stocks of existing forms. To

provide participants a reasonable time to exhaust these stocks and

begin to obtain new forms, this amendment will not be made effective

until February 16, 1995. In addition, we are providing 60 days for

interested persons to comment on this amendment (i.e., on the

requirement to use the form without modification, not on the content or

format of the form itself). Employers and other participants are

authorized to use the new form immediately. We believe it would be very

useful for those employers who must begin split sample testing on

August 15, 1994, to begin using the new form as soon as possible, since

we believe the new form is better suited to split sample testing than

its predecessors.

We emphasize that seven-part forms must be used in all cases for

split samples. Older seven-part split sample forms may continue to be

used during the six month transition period (six-part forms may never

be used in split sample testing). After that, the new seven-part form

must be used. RSPA and Coast Guard employers who choose to use single

sample collection may continue to use old six-part forms during the six

month transition period, and thereafter must use the new form,

discarding copy three.

The Alcohol Testing Form and Log Book

Currently, Copy 1 of the Alcohol Testing Form (the original) is

designated as the breath alcohol technician's (BAT's) copy of the form,

for which there is no record retention requirement stated. Copy 3 is

designated the employer's copy, which the employer must retain. It

makes more sense, in our view, for the original of the form to be

retained by the employer, rather than a copy. Consequently, we are

switching the form designations, so that Copy 1 will be the employer's

copy and Copy 3 will be the BAT's copy. The statement to be signed by

the employee in Step 4 of the form is reworded slightly to emphasize

the employee's agreement that the test reflected on the form is the

test that the employee took and that the result is recorded accurately.

In Sec. 40.59(c), in the context of the discussion of the log book,

the rule requires the notation of the ``quantified test result.'' The

Department intends that this result be the numerical result displayed

by the EBT. The term has the same meaning as the term ``result

displayed on the EBT'' elsewhere in the rule (e.g.,

Sec. 40.63(d)(1)(i)), and we are changing the term for the sake of

consistency.

Clarification of Reference to NHTSA CPL in Definition of ``EBT''

The National Highway Traffic Safety Administration (NHTSA)

Conforming Products List (CPL) for Evidential Breath Testing Devices

(EBTs) includes both devices that meet September 1993 amendments to

NHTSA's model specifications and devices that meet only the previous

version of the model specifications. Only those devices on the CPL that

meet the September 1993 model specifications may be used in the DOT

alcohol testing program. Other devices on the CPL (those designated by

an asterisk on the published CPL; see for instance 59 FR 18840 (April

20, 1994)) are not authorized for use in DOT-mandated alcohol testing

programs. We are adding a reference to the September 1993 model

specifications in the definition of ``EBT'' in Sec. 40.3 to clarify

this point.

Split Sample Collection Procedures

The Department's procedures for collecting split samples for drug

testing direct the collection site person to pour the urine from a

collection container into one or two specimen bottles (depending on the

collection method used). Some concern has been raised that this

requirement would preclude the use of newer technologies that would

subdivide a specimen into a primary and a split specimen without the

necessity of a collection site person physically pouring the urine from

one vessel into another. The Department does not intend its procedures

to preclude the use of such methods or systems, as long as they result

in primary and split samples that can be transmitted to laboratories

and tested in ways that fully comply with Part 40 requirements. We have

added language to this effect. The Department does not endorse drug

testing products, and this change should not be construed as an

endorsement of any particular product.

In using whichever of the authorized methods of collecting split

samples, the Department advises collectors that we believe the

preferred practice is to have temperature strips attached to the

collection container, which can reduce the time lag in checking the

temperature and reduce the likelihood of errors or delays. The

temperature should be read, of course, from the collection container

itself, rather than from another bottle into which the split specimen

may be poured.

Section 40.25(f)(10)(ii)(C) of the Department's current regulation

describes one of the alternative split specimen collection procedures.

In this procedure, a single specimen bottle is used as the collection

container. The collection site person pours 30 ml of the urine from

this container into a second specimen bottle, which is then used as the

primary specimen. The urine remaining in the collection container

becomes the split specimen. When DHHS published its revised drug

testing guidelines, however, DHHS provided that, in this situation, the

collection site person would pour 15 ml of the urine into the second

bottle, to be used as the split specimen, with 30 ml remaining in the

collection container, to be used as the primary specimen. In other

words, the DHHS procedure was the reverse of the one we issued in

February. While there are advantages to the procedure in the current

Part 40, we believe, on balance, that it is more important that the

DHHS guidelines and Part 40 be consistent on this point. Consequently,

we are changing our procedures to conform with those of DHHS.

Change in Temperature Range

The revised DHHS guidelines modify the temperature range within

which a specimen must fall in order to avoid creating a reason to

believe that a urine specimen has been altered or substituted. The old

range is 32.5-37.7C/90.5-99.8F. The new range is 32-38C/90-100F. Part

40 references are being changed to conform with the DHHS revision.

Clarification of Chain of Custody Requirement

Section 40.25 contains a number of references to use of chain of

custody documentation in the handling and transportation of urine

specimens. Recently, an arbitrator misinterpreted these provisions,

determining that a chain of custody was invalid, and that the test must

be canceled, because persons involved solely in the transportation of

the intact shipping container did not make a chain of custody entry.

This interpretation is contrary to Part 40 procedures, wholly

unnecessary in order to preserve the integrity of the process, and, if

followed, would result in a wholesale disruption of the DOT testing

program. As DHHS recently pointed out in its revised drug testing

guidelines, ``Since specimens are sealed in packages that would

indicate any tampering during transit to the laboratory and couriers,

express carriers, and postal service personnel do not have access to

the chain of custody forms, there is no requirement that such personnel

document chain of custody for the package during transit.''

The Department interprets its existing regulatory provisions as not

requiring couriers, postal employees, and other personnel involved in

the transportation of urine specimens to make chain of custody form

entries. Likewise, the Department interprets its existing rules as not

requiring making entries on the chain of custody form when a sealed

shipping container is put into or removed from temporary, secure

storage. In present Sec. 40.25(c), for example, handling or

transportation of a specimen from one ``place'' to another must be

accomplished through chain of custody procedures. The Department

interprets this as meaning that as long as there is an entry from an

individual authorized to release the specimen from the collection site

( ``Place'' #1) and another from an individual authorized to receive it

on behalf of the laboratory (``Place'' #2), the persons who perform

intervening, ministerial transportation services (e.g., couriers, truck

drivers, airplane pilots, postal service employees, mail room

employees) need not make such entries.

Present paragraph 40.25(h) authorizes chain of custody

documentation to be ``enclosed'' in the shipping container for shipment

to the laboratory. This container is sealed with tamper-evident tape.

As a program matter, the Department recommends enclosing chain of

custody documentation in the shipping container, as opposed to

attaching it to the exterior of the container, since this minimizes the

likelihood of loss of or damage to the documents. Interpreting the rule

to require persons performing intervening transportation services to

make chain of custody entries would nullify this important provision of

the rule. In order to make chain of custody entries, intervening

transportation personnel would have to break the tamper-evident seal,

dig out the documentation, make an entry, reinsert the documentation,

and re-seal the container. Of course, a shipping container with a seal

that had been broken and re-sealed a number of times would make it

unlikely, if not impossible, for a valid test to be conducted of the

specimen it contained. The Department could not interpret its

regulations to create such an absurd result.

Present Sec. 40.25 (k) directs the use of a chain of custody form

``from the point of collection to the final disposition of the

specimen.'' This provision directs that every individual ``in the

chain'' be identified. Unlike authorized collection site and laboratory

personnel, who actually handle the specimen, intervening transportation

personnel are not, properly speaking, ``in the chain'' at all, a point

which the Department has understood to be consistent with long-standing

case law in a variety of contexts. Consequently, the Department never

understood or intended this language to require that intervening

transportation personnel make chain of custody entries.

A related issue, raised in the same arbitration decision, concerns

temporary secure storage. That is, a collection site person conducts

the test, fills out the custody and control form, places the specimen

and form in a sealed shipping container, and places the container in

secure, temporary storage at the collection site, where a courier picks

it up subsequently for transportation to the laboratory. Again, any

tampering would be revealed by the tamper-evident seal. Here, too,

requiring an entry in the chain of custody for putting the package into

and removing it from the temporary secure storage is unnecessary and

disruptive. Alternatives, such as not sealing the chain of custody

documentation in the shipping container until immediately before

pickup, or attaching the chain of custody documentation to the outside

of the shipping container when it is ready for pickup, multiply the

possibilities for error. We emphasize that the collector should, as a

matter of good practice, document in its own records the times at which

sealed shipping containers are put into and removed from temporary

secure storage.

Notwithstanding the Department's reasonable construction of its

existing regulatory language, which has been communicated in the past

to persons raising the question, at least one arbitrator did

misinterpret these provisions. To prevent the possibility of any such

mistakes in the future, the Department it taking this opportunity to

clarify its regulations. To this end, we are adding language very

similar to that of DHHS to Sec. 40.25 (c), (h), and (k), as well as an

additional sentence that strongly emphasizes and underlines that chains

of custody need not include entries from such personnel in order to be

valid. In addition, the amendments to these paragraphs make clear that

the absence of entries in the chain of custody relating to the putting

the package into or retrieving it from temporary secure storage of the

collection site does not invalidate the chain of custody.

The Department is making this amendment effective immediately,

because it is essential to protect DOT drug testing procedures from

misinterpretations that, if followed, could invalidate virtually all

chains of custody for DOT drug tests, even though they follow Part 40

requirements. This necessity constitutes the good cause required by the

Administrative Procedure Act to make a regulation effective without the

normal 30-day effective date.

Untestable, Inadequate, or Unavailable Split Specimens

In split sample testing, there could be situations in which the

primary specimen reaches the laboratory unscathed, but the split

specimen does not. Instead, the split specimen is untestable,

inadequate, or unavailable. For example, the split specimen container

may have leaked, leaving an inadequate amount of urine for testing.

What is a laboratory to do? To answer this question, which the

Department has been asked on a number of occasions, we are adding a

paragraph to Sec. 40.29. The paragraph directs the laboratory to go

ahead and test the primary specimen in the usual way. The laboratory

then sends the result of the test of the primary specimen to the MRO in

the usual way. If the test result from the laboratory was a confirmed

positive, and the MRO verifies the result as positive, then the

employee has 72 hours to request a test of the split specimen. If the

employee does so, the MRO will pass the request on to the laboratory.

It is only at this point, and not before, that the laboratory informs

the MRO that the split specimen is untestable, inadequate, or

unavailable. The MRO would then cancel the test. This approach is

consistent with existing DOT guidance and the DHHS guidelines.

The vast majority of tests of primary specimens have negative

results. Of those that test positive, a portion are verified negative

by MROs. Of those verified positive by MROs, not all will result in a

timely request by the employee for a test of the split specimen. In

view of these facts, it would be counterproductive for the laboratory

to reject an otherwise testable primary specimen because the split

specimen was unavailable, inadequate, or untestable. Nor would it be

cost-effective for the laboratory to notify the MRO of the problem with

the split specimen at an earlier stage of the process, which could

result in the cancellation of tests that may otherwise stand up. There

is no loss of protection to the employee, who will be in no worse

position than if there was a testable split specimen. As a general

matter, employers using split sample collection should not, as a matter

of prudence, take irrevocable action (e.g., terminate, as opposed to

suspend) against an employee until the result of the split specimen is

available.

Split specimens may become unavailable for testing at other stages

of the process (e.g., the receiving laboratory mishandles or loses the

split specimen in storage, the split specimen is lost in transit

between the receiving laboratory and the second laboratory which would

analyze the split). In all these cases, the same rule applies. The MRO

is not notified of the unavailability, inadequacy, or untestability of

the split specimen unless and until there is a verified positive test

and the employee has made a timely request for a test of the split

specimen.

Reduction of Marijuana Initial Test Level

In its June 9, 1994, revision to its drug testing guidelines, DHHS

reduced the initial test level for marijuana metabolites from 100 ng/ml

to 50 ng/ml. This rule changes the initial test level for marijuana in

Part 40 to conform with the revised DHHS guidelines. This change is

consistent with the existing language of Sec. 40.29(e)(2), which states

that the initial test levels for drugs are subject to change by DHHS.

Since the new DHHS guidelines go into effect September 1, 1994, this

provision will be effective on that date, so that DHHS and DOT testing

level requirements remain consistent with one another.

Methamphetamine Levels

The Department is also adding to the chart in this section showing

confirmation test levels a new footnote 3, stating that, to be

confirmed positive, a specimen containing methamphetamine must also

contain amphetamine at a concentration equal to or greater than 200 ng/

ml. This footnote is also added to be consistent with the revised DHHS

guidelines.

Reports to Employers and Consortia

Section 40.29(g)(6), concerning monthly statistical summary reports

from laboratories to employers, has been the subject of some confusion

since it does not specify the role of consortia in the reporting chain.

Laboratories had expressed concern that they were not authorized, by

the present language of the paragraph, to provide these reports to a

consortium instead of to individual employers. The Department is

revising this paragraph to clarify this matter. Suppose a laboratory

tests specimens originating with employers 1-100, all of whom are part

of Consortium X. The laboratory may send its report summary only to

Consortium X, rather than sending 100 single reports to each of the

employers. However, the data provided to Consortium X must include

employer-specific information for each of the employers and, within 14

days of receiving the laboratory report, Consortium X is responsible

for sending the employer-specific data to each of the 100 employers.

When, as provided in the last sentence of Sec. 40.29(g)(6), employer-

specific data is withheld because no testing pertinent to the employer

was held, or because release of the data would permit inferences about

individual employees' identity, the written reports concerning the

withholding of the data may also be provided to the employer via the

consortium, through the mechanism described above.

MRO Conflicts of Interest

In its revised guidelines, DHHS has added a new provision

prohibiting relationships between laboratories and medical review

officers (MROs) that could have the reality or create the appearance of

a conflict of interest. DHHS added this provision in the belief, with

which DOT concurs, that any such relationship that could be construed

as a conflict of interest may be sufficient to undermine the integrity

of the program. For this reason and to remain consistent with DHHS

guidelines on this important issue, the Department is adding the DHHS

language to Sec. 40.29(n).

Removal of Requirement for Second Air Blank

The alcohol testing procedures in Subpart C, as originally issued,

contained a requirement that the breath alcohol technician conduct an

``air blank'' (i.e., an internal check of calibration) both before and

after every confirmation test. Failure to do so, or a result for an air

blank that exceeded 0.00, is a ``fatal flaw'' that automatically

invalidates a test. We have decided, on further reflection, that the

air blank after the confirmation test is unnecessary. The main point of

an air blank is to ensure that each employee has a testing device that

is a ``clean slate,'' unaffected by any alcohol from previous tests or

other sources. The pre-test air blank accomplishes this objective

fully; the post-test air blank is not necessary for this purpose.

Moreover, on some breath testing devices, particularly where a test has

shown a high alcohol concentration, it may take several minutes for all

alcohol to clear from the device. Under the existing rule, if the

breath alcohol technician were to do a post-test air blank under these

circumstances too soon, it could result in a reading above 0.00,

invalidating an otherwise valid test. Because it is unnecessary, and to

avoid problems of this kind, we are deleting the provision requiring a

post-test air blank and the provision making the failure to conduct

such a test a ``fatal flaw.''

Display of Sequential Test Numbers

Section 40.53(b)(2) requires that EBTs used for confirmation tests

be capable of assigning a unique sequential number to each test, which

can be read by the BAT and the employee before the test and printed out

on each copy of the test result. Section 40.79(a)(7) makes it a ``fatal

flaw'' if the sequential number displayed on the EBT before the test is

not the same as the sequential number printed on the test result.

However, the existing regulation leaves a gap between these two points,

since the procedures for conducting alcohol tests (Secs. 40.63 and

40.65) do not specify the handling of sequential numbers in the testing

process.

The Department is adding language to fill this gap. Section

40.65(e) is being revised to require the BAT to ensure that the BAT and

the employee read the displayed sequential number before the

confirmation test, and Sec. 40.65(h)(3) is revised to direct the BAT to

enter in the ``Remarks'' section of the form any disparity between that

number and the sequential test number on the printed result. Such a

disparity, per Sec. 40.79, is a fatal flaw. We have made parallel

changes to Sec. 40.63 (d)(1) and (e)(2), which apply to situations in

which a screening test is conducted with an EBT that has the features

specified in Sec. 40.53(b) for EBTs that can be used for confirmation

tests.

Record Retention Requirement for BAT Training

The alcohol testing requirements of Part 40 currently call on

employers or their agents to keep records of breath alcohol technician

(BAT) training and proficiency for two years. The Department is

concerned that, for BATs who work as such for longer than two years,

this record retention requirement may not be sufficient. The Department

requests comment on whether this record retention requirement should be

extended (e.g., to require retention of records of the training of a

BAT for as long as that BAT works for the employer). Such an extension

would not apply, presumably, to BATs who were no longer working for the

employer.

Regulatory Analyses and Notices

This is not a significant rule under Executive Order 12866 or under

the Department's Regulatory Policies and Procedures. It does not impose

costs on regulated parties and may, to a limited extent, reduce

regulatory burdens (e.g., the provisions concerning reporting and post-

test air blanks). Consequently, a regulatory evaluation has not been

prepared.

The Department finds, for purposes of the Administrative Procedure

Act, that issuance of a notice of proposed rulemaking on these subjects

is unnecessary, impracticable, or contrary to the public interest. This

is because the amendments are conforming changes to actions of the

Department of Health and Human Services or joint DOT/DHHS actions (the

change in the marijuana initial test level, the new Federal drug

testing custody and control form), important clarifications the rapid

issuance of which is in the public interest (the clarifications to the

split sample collection procedures, the chain of custody requirements,

and the laboratory reporting procedures regarding consortia), or a

correction of what we have come to regard as a mistake in procedures

that have not been implemented (removal of the post-test air blank

requirement).

The particular effective dates are established for the following

reasons. The 180-day effective date for the requirement to use the new

drug testing custody and control form is established in order to give

participants time to exhaust stocks of existing forms and also to give

interested persons a 60-day opportunity to comment on this matter. The

August 15 effective date for amendments pertaining to split sample

testing procedures was established in view of the August 15 starting

date for mandatory split sample testing in the aviation, motor carrier,

and railroad industries. The September 1 effective date for the

amendments to the initial test level for marijuana is established to be

consistent with the September 1 effective date of the revised DHHS

guidelines, with which the Department's requirements in this matter

should be consistent. The immediate effective date for the amendments

to the chain of custody is established because of the necessity of

immediately correcting an error that could create potentially serious

damage to the program.

List of Subjects in 49 CFR Part 40

Drug testing, Alcohol testing, Laboratories, Reporting and

recordkeeping requirements, Safety, Transportation.

Issued this 10th day of August 1994, at Washington, DC.

Federico Pena,

Secretary of Transportation.

For the reasons set forth in the preamble, the Department of

Transportation amends Title 49, Code of Federal Regulations, part 40,

as follows:

PART 40--PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL

TESTING PROGRAMS

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

follows:

Authority: 49 U.S.C. 102,301,322; 49 U.S.C. app. 1301nt., app.

1434nt., app. 2717, app. 1618a.

Sec. 40.3 [Amended]

2. In Sec. 40.3, the definition of the term ``EBT'' is amended by

changing the period at the end of the definition to a comma and by

adding the following: ``and identified on the CPL as conforming with

the model specifications available from the National Highway Traffic

Safety Administration, Office of Alcohol and State Programs.''

3. Section 40.23(a) is revised to read as follows:

Sec. 40.23 Preparation for testing.

* * * * *

(a) Use of the drug testing custody and control form prescribed

under this Part. This form is found in Appendix A to this part.

Employers and other participants in the DOT drug testing program may

not modify or revise this form, except that the drug testing custody

and control form may include such additional information as may be

required for billing or other legitimate purposes necessary to the

collection, provided that personal identifying information on the donor

(other than the social security number or other employee ID number) may

not be provided to the laboratory. Donor medical information may appear

only on the copy provided to the donor.

* * * * *

4. Sec. 40.25(c) is revised to read as follows:

Sec. 40.25 Specimen collection procedures.

* * * * *

(c) Chain of Custody. The chain of custody block of the drug

testing custody and control form shall be properly executed by

authorized collection site personnel upon receipt of specimens.

Handling and transportation of urine specimens from one authorized

individual or place to another shall always be accomplished through

chain of custody procedures. Since specimens and documentation are

sealed in shipping containers that would indicate any tampering during

transit to the laboratory and couriers, express carriers, and postal

service personnel do not have access to the chain of custody forms,

there is no requirement that such personnel document chain of custody

for the shipping container during transit. Nor is there a requirement

that there be a chain of custody entry when a specimen which is sealed

in such a shipping container is put into or taken out of secure storage

at the collection site prior to pickup by such personnel. This means

that the chain of custody is not broken, and a test shall not be

canceled, because couriers, express carriers, postal service personnel,

or similar persons involved solely with the transportation of a

specimen to a laboratory, have not documented their participation in

the chain of custody documentation or because the chain of custody does

not contain entries related to putting the specimen into or removing it

from secure temporary storage at the collection site. Every effort

shall be made to minimize the number of persons handling specimens.

5. In Sec. 40.25(e)(2)(i), the words ``32 deg.-38 deg. C/90 deg.-

100 deg. F'' are substituted for the words ``32.5 deg.-37.7 deg. C/

90.5 deg.-99.8 deg. F''.

6. Sec. 40.25(f)(10)(ii)(B) and (C) are revised to read as follows:

Sec. 40.25 Specimen collection procedures.

* * * * *

(f) * * *

(10) * * *

(ii) * * *

(B)(1) If a collection container is used, the collection site

person, in the presence of the donor, pours the urine into two specimen

bottles. Thirty (30) ml shall be poured into one specimen bottle, to be

used as the primary specimen. At least 15 ml shall be poured into the

other bottle, to be used as the split specimen.

(2) If a single specimen bottle is used as a collection container,

the collection site person, in the presence of the donor, shall pour 15

ml of urine from the specimen bottle into a second specimen bottle (to

be used as the split specimen) and retain the remainder (at least 30

ml) in the collection bottle (to be used as the primary specimen).

(C) Nothing in this section precludes the use of a collection

method or system that does not involve the physical pouring of urine

from one container or bottle to another by the collection site person,

provided that the method or system results in the subdivision of the

specimen into a primary (30 ml) and a split (at least 15 ml) specimen

that can be transmitted to the laboratory and tested in accordance with

the requirements of this Subpart.

* * * * *

7. In Sec. 40.25(f)(13), the words ``32 deg.-38 deg. C/90 deg.-

100 deg. F'' are substituted for the words ``32.5 deg.-37.7 deg. C/

90.5 deg.-99.8 deg. F''.

8. Sec. 40.25(h) is revised to read as follows:

Sec. 40.25 Specimen collection procedures.

* * * * *

(h) Transportation to Laboratory. Collection site personnel shall

arrange to ship the collected specimen to the drug testing laboratory.

The specimens shall be placed in shipping containers designed to

minimize the possibility of damage during shipment (e.g., specimen

boxes and/or padded mailers); and those containers shall be securely

sealed to eliminate the possibility of undetected tampering with the

specimen and/or the form. On the tape sealing the shipping container,

the collection site person shall sign and enter the date specimens were

sealed in the shipping container for shipment. The collection site

person shall ensure that the chain of custody documentation is enclosed

in each container sealed for shipment to the drug testing laboratory.

Since specimens and documentation are sealed in shipping containers

that would indicate any tampering during transit to the laboratory and

couriers, express carriers, and postal service personnel do not have

access to the chain of custody forms, there is no requirement that such

personnel document chain of custody for the shipping container during

transit. Nor is there a requirement that there be a chain of custody

entry when a specimen which is sealed in such a shipping container is

put into or taken out of secure storage at the collection site prior to

pickup by such personnel. This means that the chain of custody is not

broken, and a test shall not be canceled, because couriers, express

carriers, postal service personnel, or similar persons involved solely

with the transportation of a specimen to a laboratory, have not

documented their participation in the chain of custody documentation or

because the chain of custody does not contain entries related to

putting the specimen into or removing it from secure temporary storage

at the collection site.

* * * * *

9. Sec. 40.25(k) is revised to read as follows:

Sec. 40.25 Specimen collection procedures.

* * * * *

(k) Use of chain of custody form. A chain of custody form (and a

laboratory internal chain of custody document, where applicable), shall

be used for maintaining control and accountability of each specimen

from the point of collection to final disposition of the specimen. The

date and purpose shall be documented on the form each time a specimen

is handled or transferred and every individual in the chain of custody

shall be identified. Since specimens and documentation are sealed in

shipping containers that would indicate any tampering during transit to

the laboratory and couriers, express carriers, and postal service

personnel do not have access to the chain of custody forms, there is no

requirement that such personnel document chain of custody for the

shipping container during transit. Nor is there a requirement that

there be a chain of custody entry when a specimen which is sealed in

such a shipping container is put into or taken out of secure storage at

the collection site prior to pickup by such personnel. This means that

the chain of custody is not broken, and a test shall not be canceled,

because couriers, express carriers, postal service personnel, or

similar persons involved solely with the transportation of a specimen

to a laboratory, have not documented their participation in the chain

of custody documentation or because the chain of custody does not

contain entries related to putting the specimen into or removing it

from secure temporary storage at the collection site. Every effort

shall be made to minimize the number of persons handling specimens.

10. The existing text of Sec. 40.29(b)(1) is redesignated as

Sec. 40.29(b)(1)(i), and a new Sec. 40.29(b)(1)(ii) is added, to read

as follows:

Sec. 40.29 Laboratory analysis procedures.

* * * * *

(b) * * *

(1) * * *

(ii) Where the employer has used the split sample method, and the

laboratory observes that the split specimen is untestable, inadequate,

or unavailable for testing, the laboratory shall nevertheless test the

primary specimen. The laboratory does not inform the MRO or the

employer of the untestability, inadequacy, or unavailability of the

split specimen until and unless the primary specimen is a verified

positive test and the MRO has informed the laboratory that the employee

has requested a test of the split specimen.

* * * * *

11. In Sec. 40.29(e), the chart is revised to read as follows:

(e) * * *

------------------------------------------------------------------------

Initial test

cutoff levels

(ng/ml)

------------------------------------------------------------------------

Marijuana metabolites................................... 50

Cocaine metabolites..................................... 300

Opiate metabolites...................................... *300

Phencyclidine........................................... 25

Amphetamines............................................ 1,000

------------------------------------------------------------------------

*-25 ng/ml if immunoassay specific for free morphine.

12. In Sec. 40.29(f), the chart is revised to read as follows:

(f) * * *

------------------------------------------------------------------------

Confirmatory

test cutoff

levels (ng/ml)

------------------------------------------------------------------------

Marijuana metabolite\1\................................. 15

Cocaine metabolite\2\................................... 150

Opiates

Morphine.............................................. 300

Codeine............................................... 300

Phencyclidine........................................... 25

Amphetamines:

Amphetamine........................................... 500

Methamphetamine \3\................................... 500

------------------------------------------------------------------------

\1\Delta-9-tetrahydrocannabinol-9-carboxylic acid.

\2\Benzoylecgonine.

\3\Specimen must also contain amphetamine at a concentration greater

than or equal to 200 ng/ml.

13. Sec. 40.29(g)(6) is revised to read as follows:

Sec. 40.29 Laboratory analysis procedures.

* * * * *

(g) * * *

* * * * *

(6) The laboratory shall provide the employer an aggregate

quarterly statistical summary of urinalysis testing of the employer's

employees. Laboratories may provide the report to a consortium provided

that the laboratory provides employer-specific data and the consortium

forwards the employer-specific data to the respective employers within

14 days of receipt of the laboratory report. The laboratory shall

provide the report to the employer or consortium not more than 14

calendar days after the end of the quarter covered by the summary.

Laboratory confirmation data only shall be included from test results

reported within that quarter. The summary shall contain only the

following information:

(i) Number of specimens received for testing;

(ii) Number of specimens confirmed positive for--

(A) Marijuana metabolite

(B) Cocaine metabolite

(C) Opiates;

(D) Phencyclidine;

(E) Amphetamines;

(iii) Number of specimens for which a test was not performed.

Quarterly reports shall not contain personal identifying

information or other data from which it is reasonably likely that

information about individuals' tests can be readily inferred. If

necessary, in order to prevent disclosure of such data, the laboratory

shall not send such a report until data are sufficiently aggregated to

make such an inference unlikely. In any quarter in which a report is

withheld for this reason, or because no testing was conducted, the

laboratory shall so inform the consortium/employer in writing.

14. A new paragraph (n)(6) is added to Sec. 40.29(n), to read as

follows:

Sec. 40.29 Laboratory analysis procedures.

* * * * *

(n) * * *

* * * * *

(6) The laboratory shall not enter into any relationship with an

employer's MRO that may be construed as a potential conflict of

interest or derive any financial benefit by having an employer use a

specific MRO.

15. Sec. 40.59(b) is revised to read as follows:

Sec. 40.59 The breath alcohol testing form and log book.

* * * * *

(b) The form shall provide triplicate (or three consecutive

identical) copies. Copy 1 (white) shall be transmitted to the employer.

Copy 2 (green) shall be provided to the employee. Copy 3 (blue) shall

be retained by the BAT. Except for a form generated by an EBT, the form

shall be 8\1/2\ by 11 inches in size.

* * * * *

16. In Sec. 40.59(c), the words ``result displayed on the EBT'' are

substituted for the words ``quantified test result''.

17. In Sec. 40.63, paragraphs (d)(1), (2), and (3) are redesignated

as paragraphs (d)(2), (3), and (4), respectively, and a new paragraph

(d)(1) is added to read as follows:

Sec. 40.63 Procedures for screening tests.

* * * * *

(d)(1) If the EBT does meet the requirements of Sec. 40.53(b)(1)

through (3), the BAT shall ensure, before the screening test is

administered for each employee, that he or she and the employee read

the sequential test number displayed by the EBT.

* * * * *

18. In Sec. 40.63, paragraphs (e)(2), (3), and (4) are respectively

redesignated as paragraphs (e)(3), (4), and (2).

19. Redesignated Sec. 40.63(e)(3) is revised to read as follows:

Sec. 40.63 Procedures for screening tests.

* * * * *

(e) * * *

(3) If a test result printed by the EBT (see paragraph (d)(3) or

(d)(4) of this section) does not match the displayed result, or if a

sequential test number printed by the EBT does not match the sequential

test number displayed by the EBT prior to the screening test (see

paragraph (d)(1) of this section), the BAT shall note the disparity in

the ``Remarks'' section. Both the employee and the BAT shall initial

and sign the notation. In accordance with Sec. 40.79, the test is

invalid and the employee shall be so advised.

* * * * *

20. Sec. 40.65 (d) and (e) are revised to read as follows:

Sec. 40.65 Procedures for confirmation tests.

* * * * *

(d) Before the confirmation test is administered for each employee,

the BAT shall ensure that the EBT registers 0.00 on an air blank. If

the reading is greater than 0.00, the BAT shall conduct one more air

blank. If the reading is greater than 0.00, testing shall not proceed

using that instrument, which shall be taken out of service. However,

testing may proceed on another instrument. Any EBT taken out of service

because of failure to perform an air blank accurately shall not be used

for testing until a check of external calibration is completed and the

EBT is found to be within tolerance limits.

(e) Before the confirmation test is administered for each employee,

the BAT shall ensure that he or she and the employee read the

sequential test number displayed by the EBT.

* * * * *

21. Sec. 40.65(h) (2) and (3) are revised to read as follows:

Sec. 40.65 Procedures for confirmation tests.

* * * * *

(h) * * *

* * * * *

(2) If the employee does not sign the certification in Step 4 of

the form, it shall not be considered a refusal to be tested. In this

event, the BAT shall note the employee's failure to sign in the

``Remarks'' section.

(3) If a test result printed by the EBT (see paragraph (g)(1) or

(g)(2) of this section) does not match the displayed result, or if a

sequential test number printed by the EBT does not match the sequential

test number displayed by the EBT prior to the confirmation test (see

paragraph (e) of this section), the BAT shall note the disparity in the

``Remarks'' section. Both the employee and the BAT shall initial and

sign the notation. In accordance with Sec. 40.79, the test is invalid

and the employee shall be so advised.

* * * * *

Sec. 40.65 [Amended]

22. Sec. 40.65(h)(4) is removed.

23. In Sec. 40.65(i)(2), the comma after the words ``in writing''

is removed and the words ``(the employer copy (Copy 1) of the breath

alcohol testing form),'' are added at that place.

Sec. 40.79 [Amended]

24. In Sec. 40.79(a)(3), following the words ``0.00 prior to,'' the

words ``or after'' are removed.

25. Appendix A to part 40 is revised to read as follows:

Appendix A to Part 40--Federal Drug Testing Custody and Control

Form

BILLING CODE 4910-62-P

TR19AU94.035

TR19AU94.036

TR19AU94.037

TR19AU94.038

TR19AU94.039

TR19AU94.040

TR19AU94.041

TR19AU94.042

TR19AU94.043

TR19AU94.044

BILLING CODE 4910-62-C

26. Appendix A to Subpart C of Part 40 is redesignated as Appendix

B to Part 40 and revised to read as follows:

Appendix B to Part 40--The Breath Alcohol Testing Form

BILLING CODE 4910-62-P

TR19AU94.045

TR19AU94.046

TR19AU94.047

TR19AU94.048

TR19AU94.049

TR19AU94.050

[FR Doc. 94-20447 Filed 8-16-94; 3:09 pm]

BILLING CODE 4910-62-C