94-2031. Procedures for Transportation Workplace Drug and Alcohol Testing Programs  

  • [Federal Register Volume 59, Number 31 (Tuesday, February 15, 1994)]
    [Unknown Section]
    [Page 0]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 94-2031]
    
    
    [[Page Unknown]]
    
    [Federal Register: February 15, 1994]
    
    
    DEPARTMENT OF TRANSPORTATION
    
    Office of the Secretary
    
    49 CFR Part 40
    
    [Docket 49384, Notice 94-3]
    RIN 2105-AB95
    
     
    
    Procedures for Transportation Workplace Drug and Alcohol Testing 
    Programs
    
    AGENCY: Office of the Secretary, DOT.
    
    ACTION: Notice of proposed rulemaking.
    
    -----------------------------------------------------------------------
    
    SUMMARY: Under the Omnibus Transportation Employee Testing Act of 1991, 
    the Department of Transportation is required to implement alcohol 
    testing programs in various transportation industries. This proposed 
    rule would establish circumstances in which blood alcohol testing could 
    be used in these programs and procedures that would be used for blood 
    alcohol testing.
    
    DATES: Comments on this notice of proposed rulemaking should be 
    received by May 16, 1994. Late-filed comments will be considered to the 
    extent practicable.
    
    ADDRESSES: Comments should be sent to Docket Clerk, Att: Docket No. 
    49384, Department of Transportation, 400 7th Street, SW., room 4107, 
    Washington DC, 20590. For the convenience of persons wishing to review 
    the docket, it is requested that comments be sent in duplicate. Persons 
    wishing their comments to be acknowledged should enclose a stamped, 
    self-addressed postcard with their comment. The docket clerk will date 
    stamp the postcard and return it to the sender. Comments may be 
    reviewed at the above address from 9 a.m. through 5:30 p.m. Monday 
    through Friday.
    
    FOR FURTHER INFORMATION CONTACT: Donna Smith, Acting Director, 
    Department of Transportation Office of Drug Enforcement and Program 
    Compliance, 400 7th Street, SW., , Washington DC, 20590, room 9404, 
    202-366-3784; or Robert C. Ashby, Deputy Assistant General Counsel for 
    Regulation and Enforcement, 400 7th Street, SW., room 10424. 202-366-
    9306.
    
    SUPPLEMENTARY INFORMATION: Department published in today's Federal 
    Register a final rule (49 CFR part 40) establishing testing procedures 
    for the Department's new alcohol testing rules. The Department's 
    December 1992 NPRM for these procedures did not propose to permit blood 
    alcohol testing. Therefore, it did not include any proposed blood 
    alcohol testing procedures. Today's NPRM proposes limited circumstances 
    in which blood alcohol testing would be permitted for the covered 
    operating administrations and procedures that would be used for this 
    purpose. We seek comments on these proposed procedures and on any 
    additions, deletions, or modifications we should make to them. In 
    addition, we seek comment on the broader question of whether the 
    Department should adopt blood alcohol testing at all.
    
    Section-by-Section Analysis
    
    Section 40.71  Authorized Uses for Blood Alcohol Testing
    
        We propose to allow blood alcohol testing only in a limited set of 
    circumstances. Blood alcohol testing could be used in reasonable 
    suspicion and post-accident testing, where an evidential breath testing 
    device (EBT) is not readily available, and in place of a medical 
    evaluation in ``shy lung'' situations. If breath testing were not 
    readily available for a reasonable suspicion or post-accident test, 
    employers would have to use blood alcohol testing to meet their 
    regulatory obligations.-
        We are aware of certain advantages to blood alcohol testing. It is 
    accurate, does not require expenditures for expensive new equipment, 
    and can be conducted by qualified personnel who are generally readily 
    available even in remote locations. At the same time, blood alcohol 
    testing has a number of disadvantages, all of which are exacerbated 
    with extensive use. It is the most intrusive form of testing, it does 
    not provide an immediate confirmed result, and it necessitates 
    additional procedural complexities such as collection, laboratory, and 
    chain of custody requirements. There could be additional costs and 
    litigation. Nevertheless, because we are aware that, in some 
    circumstances the unavailability of EBTs meeting part 40 requirements 
    may make breath testing impracticable, we believe that it may be useful 
    to allow some flexibility. We think it better, in these circumstances, 
    to allow testing using a method with some disadvantages than to be 
    unable to complete a test at all. -
        Reasonable suspicion and post-accident tests are more likely than 
    other kinds of test to happen at unpredictable times and in remote 
    locations. (The time and, to some extent, place of random and pre-
    employment testing are more likely to be under the employer's control.) 
    Consequently, as commenters suggested, unless an employer incurs the 
    expense of having EBTs in all of its locations, or has an extensive 
    rapid-deployment capability, it may be substantially easier and less 
    costly to arrange for a blood alcohol test in these circumstances. In 
    some cases, it may be impossible to get an EBT to a remote location in 
    time to conduct a meaningful test.
        Particularly in remote locations, there could be situations in 
    which the only person trained to conduct alcohol tests is the 
    supervisor of an employee subject to a post-accident or reasonable 
    suspicion test. Our current rules permit a supervisor to conduct breath 
    alcohol tests, if the supervisor is a trained BAT and another BAT is 
    not available, as long as operating administration rules do not 
    prohibit this action by the supervisor. In the case of reasonable 
    suspicion tests, the operating administration rules prohibit the 
    supervisor who has made the reasonable suspicion determination from 
    conducting either the screening or confirmation test. The purpose of 
    this NPRM is to increase flexibility in post-accident and reasonable 
    suspicion testing in circumstances in which testing would otherwise be 
    difficult to accomplish. With that purpose in mind, would it make sense 
    to permit supervisors to conduct screening tests in these situations? 
    Should blood testing be treated any differently from breath testing for 
    these purposes? -
        Moreover, the number of post-accident and reasonable suspicion 
    tests is likely to be substantially lower than the numbers of pre-
    employment and random tests. This means that the disadvantages of blood 
    alcohol testing noted above will occur in a limited number of cases. 
    (The Department estimates that there will be around 2500 blood alcohol 
    tests per year under this proposal and seeks comment on whether this 
    estimate is reasonable.) If employers ``stand down'' employees on the 
    basis of the event leading to the test, the safety impact of the lack 
    of an immediate result may be further reduced.
        One of the key conditions for allowing the use of blood alcohol 
    testing is that EBTs not be ``readily available.'' Because of its 
    greater invasiveness and because it does not produce an immediate 
    result, the use of blood alcohol testing is intended to be used only in 
    those reasonable suspicion and post-accident testing circumstances 
    where it is not practicable to use breath testing. Blood alcohol 
    testing is not intended, under the proposal, to be an equal alternative 
    method that an employer can choose as a matter of preference. -
        We seek comment on when the final rule should regard an EBT as 
    being ``readily available.'' For example, if a breath test can be 
    arranged within a given time (e.g., two hours) of the event requiring 
    the test, should breath testing be regarded as readily available? What 
    should the time frame be? What if the cost of obtaining an EBT and 
    bringing it to the site for testing is a certain multiple of the cost 
    of conducting blood alcohol testing in that case? What if it were 
    simply more convenient or less expensive to use a blood alcohol test 
    rather than breath testing in a particular case? Are there other 
    criteria that could be used to determine when breath testing was 
    readily available? Should this be left to the judgment of the employer? 
    If so, how would the Department judge when this discretion had been 
    exercised properly? Should the Department require the employer to 
    document the facts that led to a decision to use blood alcohol 
    testing?-
        In context of this discussion of ``readily available,'' we would 
    point out that the EBT involved need not be one that the employer owns. 
    It could also be a device that is owned by another employer or a third-
    party provider. We do not think that it should be necessary for an 
    employer to pre-position an EBT (or enter into a contract) at every 
    possible testing location. However, we do believe it is fair to expect 
    employers to make arrangements for the use of EBTs either through 
    purchase, lease or contract, assuming normal deployment to do routine 
    random and pre-employment testing. The Department seeks comment on 
    whether, and how, these expectations should be made part of the text of 
    the final rule.--
        The NPRM proposes that, if no EBT were readily available for even 
    the screening test, a blood sample would be collected and sent to the 
    laboratory, where two tests would be conducted on the primary specimen. 
    Alternatively, if an EBT were available for the screening test, but an 
    EBT meeting part 40 requirements for use in a confirmation test were 
    not available, a blood confirmation test could be performed. Some 
    questions arise about the former situation. Would this provision 
    discourage employers from obtaining the less expensive alcohol 
    screening devices permitted by part 40? Would employers be deterred 
    from using blood as a collection method by fear of confrontations with 
    or litigation by employees who resented the intrusiveness of blood 
    alcohol testing all the more for the absence of a breath screening 
    test? Would additional supervisor training be needed? On the other 
    hand, would the majority of situations in which blood could be used 
    under this proposal likely be situations in which no EBTs at all were 
    available, so that using blood for both screening and confirmation 
    testing would be necessary in order to make the proposal meaningful?-
        The NPRM also proposes that employers could use blood alcohol 
    testing for an employee covered under the ``shy lung'' provision of the 
    Department's new alcohol testing procedures. If an employee was unable 
    to provide sufficient breath for a breath test, the employer could 
    choose either to refer the employee for a medical evaluation or to draw 
    a blood sample as provided in this NPRM. -
        Whether for liability reasons or on the basis of the events leading 
    to a post-accident or reasonable suspicion test, many employers might 
    prefer to ``stand down'' the employee pending the receipt of the 
    laboratory result of the blood alcohol test. Is it necessary for the 
    Department's regulations to address this subject? If so, what should 
    the rules provide?
    
    Section 40.73  Collection Procedures for Blood Alcohol Tests-
    
        We think it will not be necessary to establish extensive new 
    procedures for collecting blood samples, given the limited 
    circumstances in which use of this method would be authorized. (The 
    situation would probably be different if blood testing were being 
    proposed for pre-employment and random testing as well.) Collection of 
    blood specimens for forensic purposes such as law enforcement is 
    considered standard procedure at many medical facilities. For these 
    reasons, we believe that we should depend, to the extent possible, on 
    existing resources and programs. We propose that anyone who is 
    licensed, certified, or otherwise authorized under state law to draw 
    blood could do so in the State for purposes of the DOT program. In most 
    states, physicians, nurses, phlebotomists, and sometimes other medical 
    personnel, have this authority. -
        It is our understanding that states, for law enforcement and other 
    forensic purposes, have approved procedures for collecting blood 
    specimens for the purpose of alcohol testing. Except to the extent that 
    DOT rules specify certain requirements, the NPRM would allow a blood 
    specimen to be collected for purposes of the DOT program in accordance 
    with these existing state procedures. As with personnel qualifications 
    and specimen collection procedures, chain of custody requirements would 
    follow state requirements for law enforcement and other forensic blood 
    collections. The Department seeks comment on whether reliance on state 
    requirements would produce too much confusion or inconsistency, such 
    that nationwide, uniform DOT procedures would be preferable. On the 
    other hand, would such uniform DOT procedures make it too difficult to 
    operate a blood testing program for a relatively small number of 
    samples, reducing flexibility that this proposal is designed to permit?
        The NPRM would require 20 ml of blood to be drawn for the test. As 
    explained in the preamble to the final rule for part 40 published 
    today, there is a statutory requirement for collecting split samples of 
    body fluids in FAA, FTA, FRA, and FHWA programs. In this situation, the 
    sample would be subdivided into two 10 ml tubes. Collections under the 
    RSPA rule, where split samples are not required, would require only 10 
    ml of blood, placed in one tube. The NPRM would require certain 
    standard testing materials to be used, which would be provided by 
    testing laboratories in a sealed kit. The kit would include the blood 
    tubes, labels, chain of custody form, blood extraction device, and 
    swab. We seek comment on whether it is advisable to require the 
    inclusion of blood extraction devices. That is, is including these 
    materials needed, in light of the resources available at testing sites? 
    Would including them give rise to concerns about theft? We also seek 
    comment on whether the kit should also include standardized collection 
    instructions. The employer would be responsible for ensuring the kit 
    was available at the testing location.
    
    Section 40.75  Laboratories for Blood Alcohol Testing
    
        The regulatory text of this proposed section is a place-holder. One 
    of the most difficult questions facing the Department is how to ensure 
    that appropriately well-qualified laboratories test blood specimens for 
    alcohol. Absent a satisfactory answer to this question, the viability 
    of this proposed rule is in question.
        One approach the Department could take, which is consistent with 
    the approach of using existing resources to the extent practicable, is 
    to rely on those laboratories--whether state-operated or private--that 
    conduct forensic blood alcohol tests for law enforcement and other 
    purposes in each state. The final rule would assume, in effect, that a 
    laboratory whose findings were deemed sufficient under state law to act 
    as the basis for criminal or civil penalties against persons in DUI or 
    similar cases was adequate for DOT workplace testing program purposes. 
    In order for this approach to work, there would have to be state or 
    state-approved laboratories in a sufficient number of states that had 
    the willingness and capacity to accept and process ``DOT'' blood 
    specimens. We see no reason why laboratories in every state would 
    necessarily have to participate. Since we expect few blood alcohol 
    tests, large numbers of laboratories would not be necessary, and 
    specimens could be sent to a laboratory in any state that accepts 
    commercial business. The Department seeks comments on the capacity and 
    suitability of such laboratories.
        A second approach would be to construct a system based on the 
    laboratories certified by the Department of Health and Human Services 
    (DHHS) for urine drug testing. DHHS has carefully reviewed the overall 
    proficiency and forensic capability of these laboratories, and they are 
    available to users throughout the country. Many DHHS-certified 
    laboratories currently perform blood alcohol testing, but there is no 
    blood alcohol testing proficiency requirement involved with DHHS 
    certification. Under this approach, the Department, in cooperation with 
    DHHS, could develop a proficiency requirement for blood alcohol 
    testing. Such a requirement could be implemented through a DOT-DHHS 
    agreement calling for DHHS certification and inspection for blood 
    alcohol testing purposes.
        This approach would require DOT and DHHS to work out an agreement. 
    The cost of the certification program--both to the Department and to 
    laboratories--is not yet known, though the Department is working with 
    DHHS to develop this information. The cost to the Federal government of 
    this certification program would have to be recovered from the 
    laboratories via user fees. Given the small number of tests, it is 
    questionable whether laboratories would find it cost-effective to 
    become certified for blood alcohol testing, though there could be some 
    pressure from customers to process blood as well as urine samples. The 
    Department seeks comments on the advantages and disadvantages of this 
    approach.
        There are other possibilities. For example, the Department could 
    use laboratories certified by private certifying bodies, though the 
    Department has expressly declined to do so in its drug testing program. 
    DOT and DHHS both believe that the DHHS approval process for 
    laboratories provides a more thorough and intense review of laboratory 
    quality than existing private certification programs. The Department 
    could also contract with one or more laboratories to conduct the needed 
    tests. It is likely that user fees would be needed to fund such an 
    approach. The Department seeks comment on any additional approaches 
    that commenters believe have merit.
        This discussion of the need for laboratory certification is in the 
    context of a testing program that does not provide for evidentiary 
    proceedings in which an individual could challenge test results. 
    Existing Coast Guard alcohol testing regulations provide for post-
    accident blood testing in some situations. The validity of these 
    proceedings is subject to evidentiary hearings, has long been 
    recognized in administrative and court decisions, and is not brought 
    into question by the Department's proposals concerning laboratory 
    certification.
    
    Section 40.77  Testing of Blood Specimens
    
        The basic scheme of this provision is similar to the process the 
    laboratory uses for drug testing. An aliquot of the primary specimen is 
    tested by gas chromatography (GC) or enzyme assay. (Because testing for 
    alcohol is simpler chemically than testing for drug metabolites, mass 
    spectrometry is not needed.) If the alcohol concentration is less than 
    0.04, the laboratory reports a negative test to the employer. If the 
    result is 0.04 or above, then the laboratory conducts a GC test on a 
    second aliquot of the primary specimen. If the alcohol concentration is 
    less than 0.04, the laboratory reports a negative test to the employer. 
    If the result is 0.04 or above, the laboratory reports the quantitative 
    (positive) result to the employer.
        The split sample procedure also operates in an analogous way to the 
    drug testing procedures. If the employee requests a test of the split 
    specimen within 72 hours of being informed of the positive result, the 
    employer tells the laboratory to send the split specimen to a second 
    laboratory, which runs a single GC test on the split specimen. As under 
    the drug testing procedures, the employee would have the opportunity to 
    present evidence that he or she had been unable to make the request 
    within the 72-hour time frame. If the result is 0.04 or above, the 
    positive test result stands. If the result is less than 0.04, the test 
    result is invalid. The consequences of the test result would not be 
    stayed pending the test of the split specimen; the employee would 
    remain barred from performing safety-sensitive functions pending the 
    receipt of the analysis of the split specimen, unless the employee had 
    met the conditions in the applicable operating administration rule for 
    return to duty.-
        Because the time when one could gain a safety benefit from removing 
    from safety-sensitive functions an employee testing between 0.02 and 
    .039 will long since have passed, these procedures do not call for 
    taking any action with respect to a test result in this range. The 
    Department seeks comment on whether this approach makes sense and on 
    whether there are any reasons to report such results to the employer. 
    The Department also notes that the proposed procedure calls for two 
    tests to be conducted on the primary specimen even if there has been a 
    screening test on a preliminary EBT. The reason for this requirement is 
    to avoid confusion at the laboratory by requiring a standard procedure 
    in all cases, even where one of the two tests is, strictly speaking, 
    unnecessary. The Department also seeks comment on this proposal.
    
    Section 40.79(b)  Invalid Tests
    
        This paragraph would be added to the existing list of fatal flaws 
    for breath alcohol tests. It would spell out those actions that would 
    automatically cause a test to be deemed invalid. The paragraph is 
    intended to provide protections for the accuracy of the process 
    equivalent to those provided for breath alcohol testing and urine drug 
    testing.
        We seek comment on whether it should be a fatal flaw if an 
    unauthorized person has succeeded in drawing a blood sample from an 
    employee. Once the sample has been drawn, does the lack of 
    authorization of the individual drawing the sample affect its accuracy? 
    Should this be a fatal flaw simply as a means of ensuring that 
    appropriately qualified people draw blood, regardless of the effects on 
    sample accuracy?
        In some circumstances, it may be unclear to the personnel involved 
    what state a test occurs in (e.g., a post-accident test on a bridge 
    between two states). The procedures of the two states may differ. 
    Should the rule be modified to avoid the invalidation of a test just 
    because the procedures used turned out to pertain to the wrong state?
    
    Regulatory Analyses and Notices
    
        Because of substantial public interest and substantial impacts on a 
    wide range of private and public sector organizations, the Department 
    has determined that this proposed rule--in conjunction with the 
    operating administrations' alcohol and drug testing rules and the 
    remainder of the alcohol testing portion of part 40--is significant 
    under Executive Order 12866. OMB has reviewed this NPRM under that 
    Order. The NPRM is also significant under the Department's regulatory 
    policies and procedures.
        The Department has prepared a regulatory evaluation for the alcohol 
    portion of part 40, which we have included in the docket. The costs of 
    the application of part 40 procedures to the programs of the various 
    operating administrations are estimated in each of the operating 
    administrations' regulatory evaluations for their final alcohol rules 
    being published today. At the time of a final rule based on this NPRM, 
    the covered operating administrations will supplement their part 40 
    alcohol testing rule regulatory evaluations as needed with respect to 
    blood alcohol testing.
        The Department expects that this proposal, if implemented, will 
    lower costs to employers by providing more flexibility and decreasing 
    the number of EBTs needed. As noted above, the Department estimates 
    that there would be about 2500 blood alcohol tests annually, under all 
    five affected operating administration rules. The Department expects 
    that the amount of employee time involved in drawing blood would be 
    about the same time involved in breath testing. We seek comment on 
    these matters.
        This NPRM, in conjunction with the operating administration drug 
    and alcohol testing rules, is likely to have a significant economic 
    impact on a substantial number of small entities. These impacts are 
    assessed in the operating administrations' supplements to their alcohol 
    testing rule regulatory evaluations. The Federalism impacts of this 
    rule are either minimal or required by statute; for these reasons, we 
    have not prepared a Federalism assessment.
    
    List of Subjects in 49 CFR Part 40
    
        Drug testing, Reporting and recordkeeping requirements, Safety, 
    Transportation.
    
        Issued this 25th day of January 1994, at Washington, DC.----
    Federico Pena,
    Secretary of Transportation.
    
    David R. Hinson,
    Administrator, Federal Aviation Administration.
    
    Rodney E. Slater,
    Administrator, Federal Highway Administration.
    
    Jolene M. Molitoris,
    Administrator, Federal Railroad Administration.
    
    Gordon J. Linton,
    Administrator, Federal Transit Administration.
    
    Ana Sol Gutierrez,
    Acting Administrator, Research and Special Programs Administration.
        For the reasons set forth in the preamble, the Department of 
    Transportation proposes to amend title 49, Code of Federal Regulations, 
    part 40, as follows:-
    
    PART 40--PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL 
    TESTING PROGRAMS
    
        1. The authority for part 40 is proposed to continue 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 of part 40, the period following the end of the 
    definition of ``alcohol concentration'' in section 40.3 is proposed to 
    be removed, and the following words added: ``or the blood alcohol 
    concentration indicated by a blood alcohol test under this part. `` In 
    the definition of ``screening test,'' the words ``(or, where 
    authorized, blood)'' are proposed to be added between the word 
    ``breath''and the word ``specimen.''
        3. A new paragraph (d)(1) is proposed to be added to section 40.69, 
    to read as follows:
    
    
    Sec. 40.69  Inability to provide an adequate amount of breath.
    
    * * * * *-
        (d) * * * -
        (1) The employer may direct the employee to submit to a blood 
    alcohol test in accordance with the procedures of Sec. Sec.  40.71 
    through 40.77; or
    * * * * *
        4. and 5. New sections Secs. 40.71 through 40.77 are proposed to be 
    added to subpart C of part 40, to read as follows:
    
    
    Sec. 40.71  Authorized uses of blood alcohol testing.
    
        Blood alcohol testing is authorized only in the following 
    circumstances:-
        (a) When operating administration rules require a post-accident or 
    reasonable suspicion test, and an EBT is not readily available for 
    either screening or confirmation tests, blood alcohol testing shall be 
    used for both screening and confirmation test purposes.-
        (b) When operating administration rules require a post-accident or 
    reasonable suspicion test, and an EBT is readily available for the 
    screening test but an EBT suitable for confirmation testing is not 
    readily available, blood alcohol testing shall be used for confirmation 
    test purposes.-
        (c) When the employee attempts and fails to provide an adequate 
    amount of breath, blood alcohol testing may be used for both screening 
    and confirmation test purposes.-
    
    
    Sec. 40.73  Collection procedures for blood alcohol tests.-
    
        (a) Personnel who conduct blood alcohol tests shall be licensed, 
    certified, or otherwise authorized under state law to draw blood in the 
    State in which the test takes place.
        (b) The drawing of blood shall be conducted using a blood alcohol 
    test kit containing the following items:-
        (1) Two evacuated gray-capped glass tubes (except that for a kit to 
    be used only for testing under the Research and Special Programs 
    Administration (RSPA) rule, there is required to be only one such 
    tube);
        (2) A chain of custody form;
        (3) A label for each tube;
        (4) A sterile, non-alcohol swab; and
        (5) An appropriate, disposable blood extraction device.
        (c) The employer shall use only a blood alcohol test kit obtained 
    from a laboratory meeting the requirements of Sec. 40.75. Employers 
    shall use kits in accordance with the supplier's instructions, and 
    shall not use a kit after its expiration date. Employers shall not re-
    use a blood extraction device.-
        (d) The drawing of blood shall be conducted in accordance with 
    forensic blood alcohol collection procedures approved in the State in 
    which the test takes place.-
        (e) (1) Except as provided in this paragraph, at least 20 ml of 
    venous blood shall be drawn and subdivided into two equal portions of 
    10 ml each. The collector shall place each portion in a separate 
    evacuated gray-capped tube, and label and seal the tubes. The collector 
    shall designate one of the tubes as the primary specimen and the other 
    as the split specimen.-
        (2) Blood samples collected pursuant to the RSPA alcohol testing 
    rule are not required to be subdivided. For tests required by only the 
    RSPA alcohol testing rule, the collector shall draw 10 ml of venous 
    blood and place it in an evacuated gray-capped tube, and label and seal 
    the tube. -
        (f) Blood specimens shall be shipped to the laboratory, together 
    with documentation of the chain of custody meeting forensic standards 
    acceptable under the law of the State in which the test takes place.
    
    
    Sec. 40.75  Laboratories for blood alcohol testing.-
    
        Blood alcohol testing under this part shall be conducted only in 
    laboratories where such testing is authorized by Department of 
    Transportation regulations. -
    
    
    Sec. 40.77  Testing of blood specimens.-
    
        (a) When the split sample method has been used, the laboratory 
    shall retain the tube designated as the split specimen in secure 
    refrigerated storage, with the seal intact. If the seal on the tube 
    designated as the primary specimen has been broken, or the primary 
    specimen is otherwise unavailable for testing, the laboratory shall use 
    the tube designated as the split specimen in its place.-
        (b) The laboratory shall analyze an aliquot of the primary (or 
    sole) specimen for its alcohol concentration, using gas chromatography 
    or an enzyme assay, at a cutoff level of 0.04. If the result of this 
    analysis is an alcohol concentration of less than 0.04, the laboratory 
    shall report the result of the test to the employer as negative. In 
    this case, the laboratory may discard the split specimen. If the 
    alcohol concentration is 0.04 or greater, the laboratory shall analyze 
    a second aliquot of the primary specimen, using gas chromatography. --
        (c) If the result of the analysis of the second aliquot is an 
    alcohol concentration of less than 0.04, the laboratory shall report 
    the result of the test to the employer as negative. In this case, the 
    laboratory may discard the split specimen.
        (d) If the result of the analysis of the second aliquot is an 
    alcohol concentration of 0.04 or greater, the laboratory shall report 
    the quantitative result to the employer. In this case, where the split 
    sample collection method has been used, the laboratory will retain the 
    split specimen in secure refrigerated or frozen storage, with the seal 
    intact, for 60 days from the date the laboratory acquires the sample.
        (e) (1) At the time the employer informs the employee that the 
    employee's test result is 0.04 or greater, the employer shall inform 
    the employee that the employee has 72 hours in which to request a test 
    of the split specimen. If the employee requests a test of the split 
    specimen within 72 hours, the employer shall direct the laboratory to 
    release the split specimen for testing.
        (2) If an employee has not contacted the employer within 72 hours, 
    as provided in paragraph (e)(1) of this section, the employee may 
    present to the employer information documenting that serious illness, 
    injury, inability to contact the employer, lack of actual notice of the 
    verified positive test, or other circumstances unavoidably prevented 
    the employee from timely contacting the employer. If the employer 
    concludes that there is a legitimate explanation for the employee's 
    failure to contact the employer within 72 hours, the employer shall 
    direct that the analysis of the split specimen be performed.
        (3) Pending receipt of the result of the analysis of the split 
    specimen, the employee shall not perform safety-sensitive functions, 
    unless the employee has met conditions in the applicable operating 
    administration rule for return to safety-sensitive functions following 
    a test result of 0.04 or greater.
        (4) The laboratory shall ship the split specimen, with seal intact, 
    and with appropriate chain of custody documentation, to a second 
    laboratory meeting the requirements of Sec. 40.75. The second 
    laboratory shall analyze the split specimen for its alcohol 
    concentration, using gas chromatography, at a cutoff level of 0.04.
        (5) If the result of the analysis of the split specimen is an 
    alcohol concentration of 0.04 or above, the laboratory shall report to 
    the employer that the result of the test of the primary specimen has 
    been reconfirmed. -
        (6) If the result of this test is an alcohol concentration of less 
    than 0.04, or if any of the circumstances set forth in Sec. 40.79(b)(8) 
    occur, the laboratory shall report to the employer that the result of 
    the test of the primary specimen has not been reconfirmed, and 
    therefore, the test is invalid.
        6. A new paragraph (b) is proposed to be added to Sec. 40.79, to 
    read as follows:
    
    
    Sec. 40.79  Invalid tests.-
    
    * * * * *
        (b) A blood alcohol test shall be invalid under the following 
    circumstances:-
        (1) The person who draws the blood sample from the employee is not 
    authorized to do so under the law of the State in which the sample is 
    drawn;-
        (2) The test was not conducted in accordance with forensic blood 
    alcohol collection procedures approved in the State in which the test 
    takes place;-
        (3) The chain of custody does not meet forensic standards 
    acceptable under the law of the State in which the blood is drawn or 
    there is a break in the chain of custody;
        (4) The volume of the specimen used for the primary blood alcohol 
    test (i.e., as distinct from the split specimen) is less than 10 ml; 
    except that if, upon arrival at the laboratory, the specimen volume is 
    not less than 8 ml, the laboratory may accept the specimen if the 
    laboratory can ensure that sufficient volume will be available for 
    testing and any necessary reanalyses for quality control;
        (5) The seal on both specimens (or the only specimen) is broken or 
    shows evidence of tampering;
        (6) The test did not take place in a laboratory meeting the 
    requirements of Sec. 40.75.
        (7) The testing methods prescribed in Sec. 40.77(b) are not used;-
        (8) If, after an employee makes a timely request for a test of the 
    split specimen under Sec. 40.77(e)--
        (i) The split specimen is unavailable for testing;-
        (ii) There is insufficient blood to permit a valid reconfirmation 
    test to be conducted;
        (iii) The seal on the tube containing the split specimen has been 
    broken prior to testing at the second laboratory, or otherwise shows 
    evidence of tampering;
        (iv) The split specimen has not been retained in secure and 
    refrigerated storage prior to being transmitted to the second 
    laboratory;-
        (v) The inter-laboratory chain of custody is incomplete; or-
        (vi) The test of the split specimen fails to reconfirm the presence 
    of alcohol at a level of at least 0.04.
    
    [FR Doc. 94-2031 Filed 02-03-94; 1:00 pm]
    BILLING CODE 4910-62-U
    
    
    

Document Information

Published:
02/15/1994
Department:
Transportation Department
Entry Type:
Uncategorized Document
Action:
Notice of proposed rulemaking.
Document Number:
94-2031
Dates:
Comments on this notice of proposed rulemaking should be received by May 16, 1994. Late-filed comments will be considered to the extent practicable.
Pages:
0-0 (1 pages)
Docket Numbers:
Federal Register: February 15, 1994, Docket 49384, Notice 94-3
RINs:
2105-AB95
CFR: (7)
49 CFR 40.3
49 CFR 40.69
49 CFR 40.71
49 CFR 40.73
49 CFR 40.75
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