{"operation":"document","citation":null,"title":"Procedures for Transportation Workplace Drug and Alcohol Testing Programs and Proposed Model Specifications for Screening Devices To Measure Alcohol in Bodily Fluids; Final Rule, Proposed Rule, Notice DEPARTMENT OF TRANSPORTATION","source_type":"rulemaking","agency":"Office of the Federal Register","status":"historical","official":true,"published_on":"1994-02-15","effective_on":"1994-03-17","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 rule establishes uniform testing procedures that would be used by all Department of Transportation operating administrations conducting alcohol testing programs under the Act or conducting alcohol testing programs modeled on those required by the Act. This rule also implements changes required by the statute in the Department's drug testing procedures.","machine_formats":{"json":"https://regulus.evalyn.ai/document/federal-register-94-2030.json","markdown":"https://regulus.evalyn.ai/document/federal-register-94-2030.md"},"app_url":"https://regulus.evalyn.ai/document/federal-register-94-2030","source_url":"https://www.federalregister.gov/documents/1994/02/15/94-2030/procedures-for-transportation-workplace-drug-and-alcohol-testing-programs-and-proposed-model","body":"Federal Register, Volume 59 Issue 31 (Tuesday, February 15, 1994) [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: 94-2030] [[Page Unknown]] [Federal Register: February 15, 1994] _______________________________________________________________________ Part III Department of Transportation _______________________________________________________________________ Office of the Secretary National Highway Traffic Safety Administration _______________________________________________________________________ 49 CFR Part 40 Procedures for Transportation Workplace Drug and Alcohol Testing Programs and Proposed Model Specifications for Screening Devices To Measure Alcohol in Bodily Fluids; Final Rule, Proposed Rule, Notice DEPARTMENT OF TRANSPORTATION Office of the Secretary 49 CFR Part 40 [Docket 48513] RIN 2105-AB95 Procedures for Transportation Workplace Drug and Alcohol Testing Programs AGENCY: Office of the Secretary, DOT. ACTION: Final rule. ----------------------------------------------------------------------- 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 rule establishes uniform testing procedures that would be used by all Department of Transportation operating administrations conducting alcohol testing programs under the Act or conducting alcohol testing programs modeled on those required by the Act. This rule also implements changes required by the statute in the Department's drug testing procedures. DATES: Effective Dates: This rule is effective March 17, 1994, except Sec. 40.25(f)(10)(i)(B), which is effective August 15, 1994. Compliance Date: Compliance with Sec. 40.25(f)(10)(i)(B) is authorized beginning March 17, 1994. 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: Background The Omnibus Transportation Employee Testing Act of 1991, enacted October 28, 1991, directed significant changes in the Department of Transportation's substance abuse-related programs for most transportation industries that the Department regulates. These changes are discussed in detail in the Common Preamble published in today's Federal Register. With respect to drug testing procedures, the Act added a requirement for using the ``split sample'' approach to testing, which Congress believed would provide an additional safeguard for employees. The Act also imposes a variety of requirements for alcohol testing procedures, which this regulation also implements. The Coast Guard is not amending its existing alcohol testing regulations (33 CFR part 95 and 46 CFR part 4), and will continue to use separate procedures for that testing. The Department's drug testing procedures, 49 CFR part 40, have governed drug testing under all six operating administration drug testing rules since 1988. Likewise, this rule governs alcohol testing procedures for the five modes affected (the Coast Guard is not covered by the alcohol testing procedures of this part). Under the rule, the existing drug testing procedures become a separate subpart of the regulation, and we are adding new subpart containing the alcohol testing procedures. Having all the Department's uniform drug and alcohol testing procedures in a single regulation will simplify compliance for covered parties and avoid confusion by permitting all parties to look to one source for information on these issues. This should be particularly helpful to those employers who have employees covered by more than one DOT operating administration. However, employers regulated solely by the Coast Guard should continue to refer to 33 CFR part 95 and 46 CFR part 4 for alcohol testing requirements and procedures. The Department published the Notice of Proposed Rulemaking (NPRM) for this rule on December 15, 1992, at the same time as the operating administrations (OAs) published their proposed alcohol and, in some cases, drug testing rules. We received over 250 comments to the part 40 docket. In addition, the OAs' dockets received some comments on the testing procedure issues raised by the part 40 NPRM. The Department considered all these comments. Comments and Responses Split Sample Procedures for Drug Testing This discussion concerns how we will carry out a statutory requirement to use the ``split sample'' method for collecting and analyzing urine samples for purposes of the Department's drug testing program. The Act requires split samples to be used for testing under the Federal Highway Administration (FHWA), Federal Aviation Administration (FAA), Federal Transit Administration (FTA), and Federal Railroad Administration (FRA) rules. Mandatory Use of Split Sample Method The NPRM proposed to implement the statutory requirement for split samples in drug testing by making mandatory the optional split sample procedure in the existing part 40. The procedure would remain optional under the Research and Special Programs Administration (RSPA) and Coast Guard drug testing rules, which are not affected by the Act. Several commenters wanted the split sample procedure to remain optional in all modes. Because the statute requires the use of split samples in the four OAs mentioned above, the Department cannot adopt this comment. In order to give employers time to prepare to use the split sample collection method, the rule does not require affected employers to begin using this method until 6 months from the date of this rule's publication. Employers, who under the existing rule have the option of using this approach, may begin using the split sample method at any time. Sample Volume The NPRM proposed that the total amount of urine collected be 45 ml (30 ml for the primary specimen and 15 ml for the split specimen). The existing rule calls for a 60 ml collection; the Department believed that this was a greater quantity than is needed. Eighteen comments supported the NPRM proposal; two commenters opposed the proposal, one of whom supported collecting 60 ml each for the primary and split specimens. Based on information about laboratory testing needs gained over the course of four years of implementing a drug testing program, the Department is persuaded that 45 ml (30 ml for the primary specimen and 15 ml for the split specimen) is sufficient. This reduction from the current 60 ml minimum should also reduce ``shy bladder'' situations in which a test is canceled for lack of sufficient specimen volume. Time Period for Requesting Test of Split Specimen Another subject of interest to commenters was the time frame in which employees could request a test of a split specimen. The NPRM proposed a 72-hour period, following the employee's being informed of a verified positive test, during which he or she could request a test of the split specimen. Twenty commenters favored this approach, saying that this period was sufficient to allow an employee to make a choice about whether to request the test of the split specimen. Some of these commenters also asserted that allowing the much longer times permitted under some OA regulations (e.g., 60 days) could lead to tests of deteriorated samples and unreasonably postpone employer disciplinary actions. Seven commenters suggested a longer time frame (e.g., a week, 20 days, 30 days, or 60 days). One of these comments asserted that employees needed a longer time to become aware of their rights, study their options, and seek representation. Three commenters favored a uniform time frame applicable to all OA rules, while one favored allowing each OA to set its own time frame. One commenter asked whether medical review officers (MROs) were required to inform employees of the time period available to request a test of a split specimen. The Department will adopt, on a uniform basis, the 72-hour time period. The Act requires the Department's procedures to provide for a test of the split specimen ``if the individual requests the independent test within 3 days of being advised of the results of the confirmation test.'' To comply with the statute, the Department is not required to provide a time period longer than 72 hours. Moreover, the Department has not seen a persuasive rationale for permitting a longer time period. Nothing prevents an employee who is told of a verified positive test from deciding in a very short time to seek a test of the split specimen. For example, some employees testing positive admit that they used drugs. Such employees may well not believe that testing the split specimen is necessary. If the employee concedes that the test was accurate, but contends that the MRO should have verified the test negative based on information concerning legitimate use of a drug, the employee is likely to seek redress other than a test of the split specimen. If, on the other hand, the employee is adamant that he or she never used a prohibited substance, or believes that the laboratory erred, the employee may well seek a test of the split specimen. None of these decisions on the employee's part need take more than 72 hours. Decisions concerning legal options, representation etc. can be made in the time frames appropriate to the processes involved: the decision on whether to seek a test of a split specimen need not wait on a decision about whether or how to make use of a grievance procedure, for example. By saying that the 72-hour time period for requesting a test of the split specimen is a uniform requirement, we mean that any time an employee makes a request for a split specimen test within 72 hours of being informed of a verified positive test, the split specimen must be tested. Except in the limited circumstances discussed below, employers or MROs are not required by part 40 to provide for a test of a split specimen if the employee makes the request more than 72 hours after being informed of a verified positive test. There is no information in the rulemaking record to support the need of employees in any particular industry for a longer time period. Nothing in this provision prohibits an employer from voluntarily (e.g., as part of a labor- management agreement) honoring a request for a test of a split specimen made after 72 hours. The suggestion that MROs inform employees of this time period is a good one. To make the 72-hour period for making a choice on testing a split specimen meaningful, it is necessary to ensure that the employee knows about the timeframe. For this reason, we have added to the final rule a requirement that the MRO notify each employee about this choice. We have inserted parallel language concerning requests for the reanalysis of the primary specimen in situations (i.e., under the Coast Guard and RSPA drug rules) where the split sample collection method is not used. Under the final rule, when the MRO tells the employee that he or she has a confirmed positive test, the MRO must also tell the employee that he or she will have 72 hours following notice of a verified positive test in which to request a test of the split specimen. This notification is required in all cases of confirmed positive laboratory results, except in those situations in which an employee has effectively waived the opportunity to talk to the MRO. The 72-hour clock does not start to run until the time when the employee is notified, whether by the MRO or the employer, that the test result is a verified positive. The employee is not required to wait until after a verified positive test in order to request an analysis of the split specimen. An employee could, if he or she chose, ask the MRO at the time of the notification of a confirmed positive test to initiate the test of the split specimen. The MRO would satisfy this request. The verification process would continue, and the MRO would notify the employer of the verified result in the usual way. The verification and notification processes would not be on hold pending the result of the analysis of the split specimen. Such a delay in removing from performance of a safety-sensitive function an individual with a verified positive test could not be justified on safety grounds. Once a test is verified as positive, the employee must be removed from safety-sensitive functions. The employee may not again perform safety-sensitive duties until he or she has met the conditions of the applicable operating administration rule for return to duty, pending the result of the test of the split specimen. In any situation in which the MRO does not personally notify the employee of a verified positive test, we advise the MRO, upon receipt of a request from an employee to test the split specimen, to contact the employer or other party for verification of the time the employee was notified of the verified positive test. This should help to avoid potential questions about whether the employee has made a timely request. In addition, to ensure that employees are not unfairly deprived of the opportunity to request a test of the split specimen, the Department is adding a provision to allow an employee who fails to request this test within 72 hours to present information to the MRO that the failure to make a timely request was caused by circumstances beyond the employee's control. This provision is similar to one in the existing rule concerning an employee's opportunity to convince the MRO that there was a good reason for the employee's failure to contact the MRO for verification purposes (see Sec. 40.33(c)(6)). If the employee persuades the MRO, the MRO would initiate a test of split specimen, even though the employee's request had been made after the 72-hour period ended. Number of Collection Containers With respect to the collection itself, the NPRM proposed that the employee provide the specimen into a collection container, which would, in most cases, be subdivided and poured into two separate specimen bottles. One commenter favored the proposed approach; six others said that a two-container, rather than three-container approach, made more sense. That is, in all situations--not just unusual situations, as the NPRM proposed--the employee should urinate into a specimen bottle, which would become one specimen. The collection site person would then pour an amount of the urine from that bottle into a second bottle, which would become the other specimen. Commenters said this approach would save time and money. The Department believes that these comments have merit, and the final rule permits either approach. The employer could use a collection container with the specimen subdivided and poured into two specimen bottles. Alternatively, the employer could use a specimen bottle capable of holding at least 60 ml, into which the employer would urinate. The specimen would then be subdivided, with 30 ml being poured into a second specimen bottle, which becomes the primary specimen for testing purposes. The original specimen bottle, into which the employee had urinated, would become the split specimen. This latter point may seem counter-intuitive, but there is a reason for it. We want to make sure that there is a 30 ml primary specimen. Pouring 30 ml of the void into the second specimen bottle ensures that this will be the case. If the instructions were to pour 15 ml of the void into the second bottle, to be used for the split specimen, the primary specimen might wind up with less than 30 ml of urine if the collection site person overpoured. Laboratories have informed the Department that they intend to provide only 60 ml bottles to collection sites, because of the economies of mass producing a single size container and to avoid confusion by collection site personnel. For this reason, the final rule's procedure should not result in extra costs. Storage of Split Specimens Three commenters recommended that employers be authorized to store split specimens at the collection site rather than send them to the laboratory, in order to reduce shipping costs. The Department is not adopting this suggestion. Generally, laboratories have better, more secure storage facilities than many collection sites. The chances of loss, deterioration, tampering, etc. of a specimen are likely to increase in non-laboratory locations. A uniform procedure for storage and re-shipment of split specimens is likely to reduce opportunities for error in the system. The rule also addresses the issue of how long the split specimen should remain in storage. As noted above, the employee must notify the MRO within 72 hours of being informed of a verified positive test to trigger a requirement for a test of the split specimen. Consequently, it is not necessary for the laboratory to retain the split specimen for a prolonged period. In the Department's view, it is sufficient to require the split specimen to be stored 60 days from the date it arrives at the laboratory, if a request for testing it has not been received. (The primary specimen would remain in storage for one year, as under the existing rule.) Choice of Alcohol Testing Methods and Devices NPRM Proposal The NPRM for alcohol testing procedures proposed that both the initial and confirmation tests would be done on an evidential breath testing device (EBT). An EBT is a breath testing device that is on the National Highway Traffic Safety Administration's (NHTSA) Conforming Products List (CPL), a list of breath testing devices that NHTSA has approved for use by law enforcement agencies in drunk driving cases. In addition, the EBTs would have to print out results and assign a sequential number to tests, to ensure that test results were preserved in a way that minimized the chances for human error or collusion (e.g., the disregarding of an initial positive test by an employer who did not want to lose an employee's services). The NPRM also proposed training requirements for breath alcohol technicians (BATs), who would administer the tests, and maintenance and calibration requirements for EBTs. In requiring EBTs for all testing, DOT proposed that other testing methods--blood, saliva, urine, non- evidential breath, performance testing--could not be used for either screening or confirmation tests. In summary, the Department made this proposal because EBTs are a well-established, reliable, and accurate testing method; EBTs are minimally intrusive; EBTs can provide an on- the-spot result that allows employers to take action that prevents potential safety risks; and EBTs can produce a printed record of the test result that will prevent disputes about the accuracy and integrity of the testing process. Comments Overview This proposal generated more comments than any other feature of the NPRM. Approximately 190 of the comments to part 40 addressed some aspect of testing methodology. These comments came from a variety of sources, including employers in all the industries covered by the proposed regulations, unions, laboratories, manufacturers of testing equipment and products, and consortia and third-party testing service providers. The most consistent theme among comments on this subject was a desire for greater flexibility in the choice of testing methodology than the NPRM proposed. Support for NPRM Proposal Twenty-six comments, representing employers in several industries, unions, third-party testing services, manufacturers of breath testing equipment, state police agencies, and the National Transportation Safety Board, supported the NPRM proposal. They cited as reasons for their support the non-invasiveness of breath testing, its long acceptance by courts and employees, its provision of a quantitative readout, simplicity compared to blood or urine testing, and the relatively low operating costs involved. Some of these commenters qualified their support of the NPRM proposal by saying that breath testing, while a good method, should be one of an array of options available to employers, or required only for certain types of testing (e.g., pre-employment and random) where the employer has control over the time and place of testing. Concerns About Cost of NPRM Proposal Eighty commenters, representing principally employers in all the regulated industries, third-party testing service providers, and manufacturers of other testing devices that compete with EBTs, said using EBTs for both screening and confirmation tests was too expensive. They quoted capital costs per EBT between $2-10 thousand (some EBT manufacturers who commented agreed with the lower end of this range). This cost would be multiplied, they believe, by a need to obtain EBTs for all the locations in which employers operate. For example, a trucking association cited a motor carrier that would have to buy an EBT for each of its 600 locations, at an estimated cost of $1.2 million. In addition, there would be BAT training, maintenance, and calibration costs. Commenters who talked in cost per test terms cited estimates of between $20-100 per test, which they said was much higher than for competing methods. Railroad industry employers (who now use breath testing for alcohol) said that, to reduce capital costs, EBTs should not be required to have the sequential numbering and printout capabilities proposed in the NPRM (which they said would add $1500 to the cost of an EBT). Concerns About Difficulty in Implementing NPRM Proposal Some commenters feared that there would be insufficient numbers of EBTs, BATs, and testing sites available to implement the proposal. There would be a rapid expansion of the need for EBTs (one commenter estimated a 3000-4000 percent increase in the market) that manufacturers may be unable to fulfill, as well as a rapid training need for thousands of BATs that would take substantial time to meet. Seventeen commenters (including a number of third-party service providers and employers) said that the cost of obtaining EBTs and training BATs, the unfamiliarity of many third-party testing sites with breath testing, and liability concerns would deter many potential third-party service providers from participating. This would particularly be a problem in small towns and rural areas, where the low volume of testing would make the needed investment too costly. Concern About Confrontations Twenty-eight commenters (principally third-party service providers and employers) expressed concern about the possibility of confrontations between BATs and employees. These confrontations would occur, commenters said, because the BAT--not an employer representative with supervisory authority over the employee--would be the messenger of bad news about a test result. Several commenters cited the image of a 90-pound female BAT having to deal with an angry (and perhaps intoxicated) 300-pound truck driver who had just been told he had failed an alcohol test. Other Comments About NPRM Proposal Commenters expressed other concerns about the EBT-EBT approach. Some found the process too time-consuming. Others pointed out that the collection site is commonly recognized as the weak point of the drug testing process, and that conducting the alcohol testing process there increased the chance of error. Other comments said that there were too many opportunities for human and mechanical error in the breath testing process, which, together with what they regarded as the unreliability of EBTs at low alcohol concentrations, created numerous opportunities for litigation. Some commenters also said that, if all screening and confirmation testing were done on EBTs, the two tests should be run on different machines. Legal Issues Several commenters raised legal challenges to the proposal. Nine commenters (primarily manufacturers of competing devices and unions) said that the statute requires split samples (i.e., the subdivision and retention of a portion of a sample for an additional test at a laboratory as a safeguard for the accuracy of the process) in all cases. Generally, EBTs do not retain breath samples. Therefore, these comments said, methods that permitted split samples (e.g., blood, urine, saliva) must be used. Thirty-one comments said that the statute contemplated the use of different methods for the screening and confirmation test, respectively. Eleven comments said that, since the results of EBT tests would be used to refer persons for rehabilitation or treatment, they would be considered medical devices subject to Department of Health and Human Services (DHHS) regulation. Since DHHS had not approved EBTs as medical devices, their use could be blocked. Desire for More Flexibility Seventy-five commenters (representing a wide variety of equipment manufacturers, employers, and third-party service providers) favored allowing employers to choose the best testing method for them. In addition to the virtue of flexibility, this approach would permit each employer to choose the most cost-effective method of compliance in its own circumstances. Most of these commenters appeared to favor testing methods that would use two different testing methods (e.g., non-evidential breath or saliva screening test, blood test for confirmation). Ten commenters disagreed on this point, saying that non-evidential screening tests should never be permitted. Their primary concern was about the accuracy of these testing methods. Several commenters who favored using non- evidential screening tests conceded that it would probably be necessary to suspend an employee's performance of safety sensitive functions pending a confirmation test of a positive non-evidential screening test. Most commenters who addressed confirmation procedures in a two- method system said that confirmation tests (of whatever body fluid) should be done on GC (gas chromatography, the same highly accurate method used for confirmation tests under the drug testing program). Specific Comments on Other Testing Methods Non-Evidential Breath Testing Devices (e.g., tubes filled with materials that turn a certain color when alcohol-laden breath is blown into them or small, hand-held electronic devices that register the presence or absence of alcohol concentration in breath) Twenty-nine commenters, including a variety of employers and manufacturers of the devices, supported using non-evidential breath testing devices. Most commenters cited cost (estimated at between $90- 550 for various models of non-evidential breath testing machines, and about $2-4 each for disposable devices) and convenience as reasons. A few opponents of non-evidential breath testing devices said their accuracy was questionable, both with respect to false positives and false negatives. Saliva Testing (i.e., a device which registers a particular alcohol concentration when a swab with saliva from the employee's mouth is inserted into it) Forty-five commenters favored the use of saliva testing. These commenters included a variety of employers, third-party service providers, equipment manufacturers, and others. Commenters claimed several advantages for use of screening saliva tests: modest cost (estimated at between $5-20 per test); simplicity of use, little need for training; existing ``approvals'' from NHTSA and Food and Drug Administration (FDA) for some devices (though in contexts other than a workplace testing program); non-invasive nature of the devices; sufficient accuracy for screening tests. Two commenters also said that, while it was most typical to use blood testing for confirmation after a saliva screen, saliva specimens could also be used for confirmation, as laboratories could run a gas chromatography analysis on saliva. A few commenters expressed concerns about saliva testing devices. A union provided data that it said showed that saliva devices had a mixed record for accuracy. Other commenters said saliva remained an unproven method, that saliva devices were not ethanol-specific, and that saliva alcohol and blood alcohol results may differ. Proponents of saliva testing devices conceded that chain of custody forms would be needed and that there was no method of automatically generating permanent records of test results that positively identified a particular employee with a particular result. They said that keeping paper records was adequate for this purpose, however. Blood Testing Forty-eight commenters (again representing a variety of employers, plus third-party providers, laboratories and others) favored allowing the use of blood testing as a confirmation test method. The advantages cited for this method included well-established scientific and legal acceptance for accuracy, the availability almost anywhere of technicians trained in drawing blood, and utility for post-accident testing on employees who are unconscious. Some of these commenters said that, while blood testing is admittedly more invasive than other methods, employees accept it because of its reputation for accuracy. Also, they said, the low expected positive rates on screening tests will mean that few blood confirmation tests would have to be performed. Commenters estimated costs to be in the $20-60 range per test. Seven commenters opposed the use of blood testing, primarily on the ground that it is too invasive. In addition, a few commenters said that DHHS or DOT would have to develop laboratory certification standards for blood testing. Some comments said that employees might have to be required to ``stand down'' during the interval between the blood collection and the return of the test result from the laboratory. Urine Testing Eight commenters favored allowing the use of urine testing, including some employers who now use this approach to their satisfaction and laboratories that do urine testing. One advantage cited for this approach is that alcohol could simply be added to the list of substances for which urine samples taken for drug testing are tested, at a low incremental cost. Commenters said that DOT or DHHS should develop laboratory certification procedures and cutoff levels. Some commenters also noted that detailed collection procedures would have to be developed, since urine testing for alcohol is more complicated than urine testing for drugs (e.g., two voids, twenty minutes apart, are recommended to measure alcohol concentration in urine). Performance Testing Five commenters, most of whom were manufacturers of the devices, supported the use of performance tests for the screening or screening test. (A performance test does not measure alcohol concentration; it measures deviations from a personal norm of reaction time, motor coordination, etc.) One commenter opposed performance testing devices as inappropriate for this program. Responses to Comments on Testing Methods Legal Issues The Act provides, with respect to confirmation testing, that all tests * * * shall be confirmed by a scientifically recognized method of testing capable of providing quantitative data regarding alcohol * * * Some comments asserted that this provision requires that a different testing method be used for the screen and confirmation tests, respectively. The statute says no such thing, stating only that the confirmation test must use a ``scientifically recognized'' method that can provide ``quantitative data'' regarding alcohol. As long as the method of confirmation meets these criteria, the statutory requirement is satisfied. Breath testing is scientifically and legally recognized as a method for accurately testing alcohol concentration, and devices meeting the Department's requirements provide quantitative data. (Blood testing, of course, also meets the statutory criteria.) The ability of a method of confirmation testing to pass these statutory tests is not dependent on the choice of a method of screening testing. Testing of breath for confirmation, as provided in this rule, is equally valid under the statute whether evidential breath testing, non-evidential breath testing, or saliva is used for the screening test. Testing of blood for confirmation is equally valid under the statute whether blood, breath, saliva or urine is used for the screening test. All that matters is that the confirmation testing method meet the statutory criteria in its own right. With respect to split samples, the Act requires the Department's regulations to provide that each specimen sample be subdivided * * * and that a portion thereof be retained in a secure manner to prevent the possibility of tampering, so that in the event the individual's confirmation tests results are positive the individual has an opportunity to have the retained portion assayed by a confirmation test done independently at a second certified laboratory if the individual requests the independent test within 3 days after being advised of the result of the confirmation test * * * Some commenters asserted that this language should be read to require that split samples be used in all alcohol testing, with the implication that a method that did not permit the use of split samples could not be used. Since most EBTs--including those proposed by the Department in the NPRM--do not retain a sample that could theoretically be subdivided and preserved for testing of a split specimen, some of these commenters asserted not only that blood or other liquid-based testing methods were required, but that breath testing was prohibited. This interpretation is flatly contrary to the statute, which specifically contemplates the use of breath testing (see, e.g., sec. 3(a) of the Act, adding section 614(d)(6) to the Federal Aviation Act). Breath testing is a well-recognized form of alcohol testing, and there is no evidence that Congress had any intention of prohibiting its use, either indirectly by requiring split samples or otherwise. The legislative history makes clear that the Senate sponsors of the legislation intended that breath testing be used and that split samples were not mandated for breath testing. In the floor debate, during a colloquy between Senators Danforth and Hollings, Senator Hollings stated [t]here are also requirements for split samples, primarily included in the legislation to allow urine samples to be retested. DOT would have the authority to determine that blood samples should be similarly handled. This specific requirement is not relevant in the case of breath testing for alcohol, but DOT is directed by this legislation to provide necessary safeguards in this area to ensure the validity of test results. 137 Cong. Rec S 14764, 14770. There is also internal evidence in the wording of the statutory provision that supports the reasonable interpretation that the split sample requirement is intended to apply to liquid body fluids like urine and blood, but not to breath. The statute uses the word ``samples'' in ways that refer primarily to samples of liquid body fluids. For example, section 614(d)((1) of the amended Federal Aviation Act refers to the need for ``privacy in the collection of specimen samples.'' Privacy is very important with respect to collection of urine samples for drug testing. Because elimination functions are not involved, privacy is not as important in breath collections. In paragraph (d)(6) of the same section, the statute refers to detecting and quantifying ``alcohol in breath and body fluid samples, including urine and blood.'' In this language, the phrase ``including urine and blood'' is best understood as modifying ``body fluid samples,'' as opposed to ``breath.'' Given the way that the term ``sample'' is used in these portions of the statute, the use in paragraph (d)(5) of ``sample'' should also be used to refer to liquid body fluid samples (i.e., urine and blood). When this paragraph speaks of the ``specimen sample be[ing] subdivided,'' then, it is imposing a split sample requirement on blood and urine, not on breath. Some commenters argued that the language mentioned above from paragraph (d)(6), requiring the Department to ``ensure appropriate safeguards for testing to detect and quantify alcohol in breath and body fluid samples, including urine and blood * * *,'' creates a right for employees to have a screening test confirmed by blood testing. This language, on its face, does not create such a requirement, since it does not specify any particular sort of test for either screening or confirmation purposes. There is ambiguous legislative history on the point, with the Senate report on the Act saying both that ``an employee testing positive for alcohol using a specimen other than blood shall be entitled, at that employees [sic] option, to a blood test'' and that ``the Committee has not specified the type of test to be used in either the screening or confirmation test.'' Given that the statute does not explicitly require blood testing for confirmation, and that the portion of the statute that mandates confirmation testing requires only a ``scientifically recognized'' confirmation test that can produce ``quantitative data'' (criteria that breath testing clearly meets), the Department does not believe it would be reasonable to view this ambiguous legislative history as a mandate for the availability of blood confirmation testing in all cases. The Department does not believe that regulations of the Food and Drug Administration (FDA) would interfere with the implementation of breath testing under this rule. FDA does regulate the safety, labeling, etc. of medical devices. It is our understanding that FDA may be considering initiatives to regulate EBTs used as medical devices in medical settings. FDA does not, however, regulate or certify the precision or accuracy of EBTs that are currently used for law enforcement purposes or that would be used under the DOT alcohol testing program. (These would not be viewed as medical devices used in medical settings.) We believe that current FDA rules are, and future FDA rules would be, consistent with NHTSA certification of EBTs. Flexibility and Cost Many commenters made flexibility in testing methods a high priority. The Department agrees that flexibility is desirable. However, the Department also believes that any testing system should meet a series of criteria, each of which is necessary to execute the statute faithfully and to ensure that the safety and accuracy goals of the program are met. The Department cannot emphasize too strongly the importance of ensuring accuracy and reliability of testing devices and methods, at both the screening and confirmation test stages. This is needed, among other reasons, to protect employees from even temporarily being identified as misusers of alcohol. In the context of drug testing litigation, the courts, in upholding the Department's program, relied to a substantial extent on the reliability and accuracy safeguards in that program. Within these constraints, our objective is to provide maximum flexibility and minimum cost. The Department's criteria for carrying out its objectives in this area are the following: As required by the statute, the method used for confirmation should be scientifically recognized and able to produce a quantitative result. The method should meet NHTSA Conforming Products List (CPL) standards at 0.02 and higher alcohol concentrations. The confirmation method should be alcohol-specific (i.e., does not produce a reading for acetone). The confirmation method should generally provide documentation of quality control/calibration and be admissible as forensic evidence in administrative proceedings. The testing method used for confirmation should provide a result at the time and place of the test, so that an employee whose continued performance of a safety sensitive function may present a safety risk can be removed from performing that function. The testing met","truncated":true,"body_characters":153409}