# Procedures for Transportation Workplace Drug and Alcohol Testing Programs

- **operation:** document
- **citation:** 73 FR 62910
- **title:** Procedures for Transportation Workplace Drug and Alcohol Testing Programs
- **source type:** rulemaking
- **agency:** Office of the Secretary
- **status:** historical
- **official:** true
- **published on:** 2008-10-22
- **effective on:** 2008-06-25
- **summary:** The Department is issuing this notice to respond to comments on the amendment to 49 CFR 40.67(b) issued as part of a final rule on June 25, 2008. The Department is not changing this amendment, which will go into effect, as scheduled, on November 1, 2008. Beginning on that date, direct observation collections will be required for all return-to-duty and follow-up tests. When additional testing methodologies appropriate for use in return-to-duty and follow-up testing (e.g., oral fluid and sweat specimens) are approved by the Department of Health and Human Services and adopted by the Department, the Department intends to make these methods available to employers and employees as an alternative to direct observation urine testing in these situations.
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- **source url:** https://www.federalregister.gov/documents/2008/10/22/E8-25102/procedures-for-transportation-workplace-drug-and-alcohol-testing-programs
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Federal Register, Volume 73 Issue 205 (Wednesday, October 22, 2008) [Federal Register Volume 73, Number 205 (Wednesday, October 22, 2008)] [Rules and Regulations] [Pages 62910-62918] From the Federal Register Online via the Government Publishing Office [ www.gpo.gov ] [FR Doc No: E8-25102] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF TRANSPORTATION Office of the Secretary 49 CFR Part 40 [Docket OST-2003-15245] RIN 2105-AD55 Procedures for Transportation Workplace Drug and Alcohol Testing Programs AGENCY: Office of the Secretary, DOT. ACTION: Response to comments. ----------------------------------------------------------------------- SUMMARY: The Department is issuing this notice to respond to comments on the amendment to 49 CFR 40.67(b) issued as part of a final rule on June 25, 2008. The Department is not changing this amendment, which will go into effect, as scheduled, on November 1, 2008. Beginning on that date, direct observation collections will be required for all return-to-duty and follow-up tests. When additional testing methodologies appropriate for use in return-to-duty and follow-up testing (e.g., oral fluid and sweat specimens) are approved by the Department of Health and Human Services and adopted by the Department, the Department intends to make these methods available to employers and employees as an alternative to direct observation urine testing in these situations. DATES: The effective date of 49 CFR 40.67(b), as amended by the Department on June 25, 2008, and delayed on August 26, 2008, is November 1, 2008. FOR FURTHER INFORMATION CONTACT: Jim L. Swart, Director, U.S. Department of Transportation, Office of Drug and Alcohol Policy and Compliance, 1200 New Jersey Avenue, SE., Washington, DC 20590; (202) 366-3784 (voice), (202) 366-3897 (fax), or [email&#160;protected] ; or Robert C. Ashby, Deputy Assistant General Counsel for Regulation and Enforcement, U.S. Department of Transportation, same address, (202) 366-9310 (voice), (202) 366-9313 (fax), or [email&#160;protected] . SUPPLEMENTARY INFORMATION: Background On October 31, 2005, the Department of Transportation issued a notice of proposed rulemaking (NPRM) to amend 49 CFR Part 40, the Department's drug and alcohol testing procedures rule (70 FR 62276). The primary purpose of the NPRM was to propose making specimen validity testing (SVT) mandatory. Mandatory SVT is an important step in combating the safety problem of cheating on drug tests. Based on this NPRM, the Department issued a final rule on June 25, 2008 (73 FR 35961). The final rule included two provisions (49 CFR 40.67(b) and (i)) concerning the use of direct observation (DO) collections, another significant tool the Department uses to combat cheating. Petitioners, including the Association of American Railroads (AAR), joined by the American Short Line and Regional Railroad Association; the Transportation Trades Department (TTD) of the American Federation of Labor and Congress of Industrial Organizations (AFL-CIO); the International Brotherhood of Teamsters; and the Air Transport Association (ATA), joined by the Regional Airline Association (RAA), asked the Department to delay the effective date of these two provisions, seek further comment on them, and reconsider them. In response to these petitions, the Department issued a notice delaying the effective date of 49 CFR 40.67(b) until November 1, 2008 (73 FR 50222; August 26, 2008). We opened a comment period on that provision, which closed on September 25, 2008. The Department did not delay the effective date of 49 CFR 40.67(i), which went into effect, as scheduled, on August 25, 2008. The history of DO collections under Part 40 goes back to the beginnings of the Department's drug testing program. The principle that animates this history is that DO, because it is intrusive, is not appropriate to use in the great mass of testing situations (e.g., all pre-employment and random tests), but only in those situations in which there is a heightened incentive to cheat or circumstances demonstrating the likelihood of cheating. In this way, the Department has maintained the proper balance between the legitimate privacy [[Page 62911]] expectations of employees and the safety and program integrity interests of the Department. As a result, DO collections constitute only a tiny percentage of the drug collections conducted each year under DOT drug testing rules. DO collections have always required the use of a same-gender observer and for the observer to watch the flow of urine from the individual's body into the collection container. In the December 1, 1989, preamble to Part 40 (54 FR 49854), we said that the limitations on using observed collections in only four circumstances would be maintained despite the fact that some comments requested that the Department allow greater discretion for observed collections. The Department decided that ``existing safeguards in Part 40 are adequate to prevent tampering and that direct observation, because of its increased intrusiveness, should be strictly limited.'' The Department considered that limiting the circumstances that would result in a DO collection is ``one factor in the balance between privacy and safety necessity considered by the courts.'' The preamble went on to say that some commenters specifically opposed direct observation ``as part of follow-up (i.e., post-positive) testing, while other commenters favored this practice.'' We said that the Department ``believes that direct observation may be a useful tool in follow-up testing.'' There was concern expressed about drug use relapses, especially for cocaine. We went on to say, ``An individual who has returned to work after rehabilitation but has suffered such a relapse may have a greater incentive to attempt to beat a follow-up test, because the employer may not provide a second opportunity for rehabilitation.'' Regarding directly observed follow-up testing, the preamble concludes, ``If the employer or EAP [employee assistance program] counselor believes that this may be the case, the opportunity for direct observation should exist.'' Currently, section 40.67(a) requires that employers direct immediate collections under direct observation in three circumstances: (1) When the laboratory reported an invalid specimen (e.g., one that has an interfering substance preventing a normal result but the laboratory cannot identify a specific adulterant) and the Medical Review Officer (MRO) reported that there was not an adequate medical explanation for the result; (2) when the MRO reports to the employer that the original positive, adulterated, or substituted test result had to be cancelled because there was not a split specimen available for testing; and (3) when the MRO reports a negative-dilute specimen with a creatinine concentration greater than or equal to 2 mg/dL or less than or equal to 5 mg/dL. We added the third provision in 2003 in an interim final rule (68 FR 31624) and revised it in an interim final rule (69 FR 64865). All these situations involve results indicating a heightened risk of cheating or that an attempt to cheat had taken place. Direct observation is also mandated at collection sites if the collector finds materials brought to the collection site to tamper with a specimen (section 40.61(f)(5)(i)), determines that a specimen is out of temperature range (section 40.65(b)(5)) or detects other evidence indicating an attempt to tamper with a specimen (section 40.65 (c)(1)). These are also situations involving evidence indicating an attempt to cheat. In addition, employers are currently allowed, but not required, to order a directly observed test under section 40.67(b) for return-to- duty and follow-up tests. We acknowledge that DO collections are, and always have been, controversial. The Department is well aware that they intrude on personal privacy to a greater extent than non-observed collection methods, and consequently we have limited the use of DO to situations where we believe using this approach is necessary to protect the integrity of the testing process and strengthen the safety objectives of the program. In the December 19, 2000 preamble to a major update to part 40 (65 FR 79462), about observed collections we said, ``Directly observed specimens are controversial because of their greater impact on employee privacy. They can be useful because they reduce the opportunity for tampering. On privacy grounds, some commenters, including unions and some service agents, would prefer not to conduct directly observed collections at all.'' (65 FR at 79489) These commenters opposed adding any situations in which direct observation was authorized or required. The 2000 preamble went on to say, ``Other commenters said that the benefit of greater protection against specimen tampering warranted direct observation in situations that suggested a heightened risk of tampering.'' (65 FR at 79489) The Department agreed with these commenters. In circumstances that pose a higher risk or greater risk for tampering, ``the interests of the integrity of the testing process, with its safety implications, outweigh the additional privacy impact of the direct observation process.'' (65 FR at 79489-79490) More recently, there has been a sharply increased emphasis, at the level of national policy, on the problem of cheating and how to deal with it. The Department has been aware for several years of the increasing proliferation of products designed and sold to help workers who use drugs defeat drug tests. As a result we have worked on specimen validity testing rulemaking. Also, based upon our concerns and those expressed to us by collection site personnel and medical review officers about use of these products, we issued in July 2007 an interpretation outlining additional examples of an employee's failure to cooperate with the testing process that would cause a refusal to test. In that interpretation we said that one refusal to test would be: ``The employee is found to have a device--such as a prosthetic appliance--the purpose of which is to interfere with providing an actual urine specimen.'' We also gave instructions to collectors about how to handle this situation. Not only was the Department working on the specimen validity testing rulemaking between 2005 and 2008, but also the United States Congress was conducting its own inquiries on the issues. During a May 17, 2005 hearing before the Investigations Committee on Energy and Commerce, the Department of Health and Human Services (HHS) provided the following testimony regarding prosthetic devices delivering synthetic or drug-free human urine: The most cumbersome, yet highly effective, way to beat a urine drug test is to use a physical belt-like device hidden under the clothing which contains a reservoir to unobtrusively hold real human urine from another person that is free from drugs, and deliver that bogus specimen into the collection container through a straw-like tube, or through a prosthetic device that looks like real human anatomy, color-matched. This last described device is heavily marketed for workplace drug testing and criminal justice urine collection situations that require directly observed urine specimens to be provided. Synthetic urine can be used in place of real human drug free urine. [Testimony before the Subcommittee on Oversight and Investigations Committee on Energy and Commerce United States House of Representatives Products Used to Thwart Detection in Drug Testing Programs, Statement of Robert L. Stephenson II, M.P.H., Director, Division of Workplace Programs Center for Substance Abuse Prevention, Substance Abuse and Mental Health Services Administration, U.S. Department of Health and Human Services at pages 4-5]. Also at the 2005 hearing, the United States Government Accountability Office (GAO) testified that: In summary, we found that products to defraud drug tests are easily obtained. They [[Page 62912]] are brazenly marketed on Web sites by vendors who boast of periodically reformulating their products so that they will not be detected in the drug test process. In addition to an array of products designed to dilute, cleanse, or substitute urine specimens submitted to testers by drug users, approximately 400 different products are available to adulterate urine samples. The sheer number of these products, and the ease with which they are marketed and distributed through the Internet, present formidable obstacles to the integrity of the drug testing process. [Testimony Statement of Robert J. Cramer, Managing Director, Office of Special Investigations, the United States Government Accountability Office (GAO), before the Chairman, Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives, GAO-05-653T, May 1, 2005]. On November 1, 2007, following media coverage regarding compromised collection integrity and security issues, the Congressional Subcommittee on Transportation and Infrastructure held a hearing on the problem of cheating on DOT-required tests. At the hearing, the GAO testified about the threat to the integrity of the testing program posed by the devices being used to substitute urine in DO collections. In its final report issued in May 2008, the GAO noted that the ease of subverting the testing process was a factor contributing to failures to detect drug use. Specifically, GAO noted that transportation employees ``are successfully adulterating or substituting their urine specimens with products that are widely available and marketed as * * * [ways to beat a test.]'' [GAO Report No. GAO-08-600, Motor Carrier Safety: Improvements to Drug Testing Programs Could Better Identify Illegal Drug Users and Keep them off the Road, May 2008 at pages 2-3.] The GAO further found that ``Several hundred products designed to dilute, cleanse, or substitute urine specimens can be easily obtained.'' [GAO Report No. GAO-08-600 at page 20.] In light of the by-now well-recognized availability of substances and devices for substituting or adulterating specimens, the Department's premise for the changes it made to section 40.67 was that taking additional steps to combat cheating on drug tests was appropriate. Such steps are needed to avoid placing the traveling public in danger of workers who try to cheat on their drug tests. Given the greater availability of means to cheat on tests, compared to the late 1980s, the Department took the position in the June 25 final rule that it is appropriate to strike the balance between the Department's interests in safety and program integrity and employees' interest in privacy at a different point than it did two decades ago. In the Omnibus Transportation Employee Testing Act of 1991, Congress recognized that, while privacy is a very important value in the drug testing process, it is not an absolute value. The Act directs the Department to ``promote, to the maximum extent practicable, individual privacy in the collection of specimens'' (49 U.S.C. 20140(c)(1), emphasis added). In issuing the June 25 final rule, the Department, took the position that it is no longer ``practicable'' to operate a drug testing program without adding countermeasures to well- publicized cheating techniques and devices. With respect specifically to the new section 40.67(b), the Department, in the June 25 final rule, said that DO collections would be required for all follow-up and return-to-duty tests. The new requirement, aimed at counteracting cheating in these tests, was included as section 40.67(b). It read, ``As an employer, you must direct a collection under direct observation of an employee if the drug test is a return-to-duty test or a follow-up test.'' Under Part 40 as it existed before this amendment, employers had the discretion to require direct observation in follow-up and return-to-duty tests, but were not mandated to do so. It is significant that employers rarely exercised this important option. Notably, the November 1, 2007 GAO report indicated that even when collectors followed the appropriate procedures for integrity and security of specimens, the GAO inspectors were able to bring adulterants into the collection sites and successfully adulterate their specimens. These adulterants went undetected during laboratory testing. The GAO report said: Even in cases where the collector followed DOT protocol and asked our investigator to empty his pockets, our investigators simply hid these products in their pockets and elsewhere in their clothing.* * * Investigators determined that there is information on the Internet about concealing drug-masking products. For example, one Web site noted that ``although most testing sites will require you to remove items from your pockets, it is still possible to sneak in another specimen.'' In the Department's view, this new requirement mandating DO for return-to-duty and follow-up testing was a logical outgrowth of the development of the Department's increasing efforts to deal with the problem of cheating in drug tests. Even though we did not foresee in 1989 the degree to which products designed to beat the drug test would later become available, the Department was concerned about specimen tampering and about the heightened motivation of those employees returning to safety sensitive positions after positive tests or refusals to tamper with their specimens. That concern has increased in recent years as information about the widespread availability of cheating products has become available. As a consequence, the Department believed, in adding this provision, that it was important for us to be consistent with the other DO collection provisions, which make DO collections mandatory in circumstances involving heightened motivation for or evidence suggesting attempts to cheat (see sections 40.61(f)(5)(i); 40.65(b)(5) and (c)(1); 40.67(a)). In all these cases, use of DO is mandatory. If safety necessitates a DO in one of these circumstances, then, the Department believed, safety likewise necessitates DO collections as part of follow-up and return-to-duty tests. The Department was mindful that everyone who has to take a return-to-duty or follow-up test had already violated the rule (e.g., by testing positive or refusing to test), showing that he or she has knowingly chosen to act in a way that presents an increased risk to transportation safety. Such employees will be acutely aware that they must test negative on all return-to- duty and follow-up tests in order to regain or retain their ability to perform safety-sensitive functions. These circumstances, the Department believed, present just the sort of heightened incentive for cheating on a test that DO collections are intended to combat. It was but a modest, incremental step from the current regulation's authorization of DO in follow-up and return-to-duty situations to the June 25 final rule's requirement for DO in these situations. Consequently, the Department believed that taking this step was timely and appropriate. Nevertheless, the NPRM had not specifically requested comments on this subject, and the Department consequently opened a comment period on this provision and delayed its effective date until November 1, 2008. In considering all issues regarding drug testing, the Department keeps squarely in mind the vital safety purposes of its program. Recent multi-fatality transportation accidents in which drug use by safety- sensitive personnel was involved underline the importance of deterring use of illegal drugs by transportation workers. When workers who use drugs believe they can get away with their misconduct by cheating, the deterrent effect of the [[Page 62913]] Department's rules is undermined. This is detrimental to public safety, and the Department cannot tolerate it. Comments and DOT Responses The docket includes 86 comments. The breakdown of comments by source is the following: Substance Abuse Professionals: 20 Unions or other employee organizations: 17 Collection sites or collection site organizations: 16 Individual employees: 10 Other individuals: 9 Employers or employer organizations: 9 Third-party Administrators: 3 Laboratories: 1 Medical Review Officers: 1 Some union and employer commenters are represented twice in this breakdown (e.g., because the docket includes a petition requesting an opportunity for further comment and an additional comment from the same organization once the docket was opened). Many of the individual comments from employees and others were submitted anonymously. Comments on Direct Observation Procedure (Section 40.67(I)) The August 26, 2008, notice opening a comment period sought comments only on the provision of section 40.67(b) that would make DO mandatory, rather than optional, in follow-up and return-to-duty testing. The notice specifically said that comments were not sought on the provisions of section 40.67(i). This section, which went into effect August 25, 2006, requires observers in directly observed collections to direct employees to raise and lower clothing and turn around, so that the observer can note any prosthetic or other device that the employee may possess in an attempt to cheat on the test. Nevertheless, a number of parties did comment on 40.67(i). One union and a comment from two employer organizations said that the Department should have postponed the effective date for this provision and opened a comment period, since in their view the notice of proposed rulemaking leading to the June 25 rule did not provide sufficient notice concerning the provision. Twenty commenters, mostly unions and individual employees, but also including a few collection sites, objected to the idea of the revised observation procedure, saying that it was too great an intrusion on employees' privacy. Many of these commenters also said that there was insufficient evidence that people in transportation industries were actually using prosthetic and other devices, and that therefore the Department's countermeasure was unnecessary. Two commenters expressed the concern that the rule could create confusion among collectors between cheating devices and medically-necessary prostheses, or devices used as a form of sexual expression, with the result that users of legitimate devices could unfairly be determined to have refused to test. Two Substance Abuse Professionals (SAPs) who commented on the provision and a Third Party Administrator (TPA) supported its inclusion, as a useful measure to counter attempts to cheat. DOT Response Because matters concerning section 40.67(i) are outside the scope of the August 26 notice, these comments are not relevant to the decision the Department is making in this document: whether the provisions of section 40.67(b) should be retained, removed, or modified. We would note, however, that the basic procedure of body-to-bottle direct observation of certain tests involving a heightened risk of cheating, or evidence of a possible attempt to cheat, has been part of the Department's testing procedure since the program's beginnings in the 1980s. As attempts to cheat even on direct observation tests have become more sophisticated over the years--the Department's 1988-89 testing procedure rules did not need to take prosthetic and other cheating devices into account, in particular--it is important for the Department's procedures to change to accommodate new circumstances. People who believe they can use cheating devices to get away with using illegal drugs while continuing to perform safety-sensitive functions are a threat to public safety. Some commenters argued that the Department has not provided data on how often prosthetic and other cheating devices are being used, so the Department need not take measures to prevent their use. The anecdotal evidence provided by several commenters to the docket, along with experience the Department has gained through the compliance activities of the DOT Agencies, provides sufficient justification to us that such devices are not only readily available, but are actually being used. The successful use of prosthetic and other cheating devices is, by nature, a matter of stealth. If someone uses such a device, and gets away with it, the drug test result will be a negative test result. Consequently, the cheater's action will never turn up in drug testing statistics. It is illogical to argue that the Department cannot take action to prevent cheating because successful cheating is absent from the program's statistics. The Department disagrees with commenters who said that there was insufficient notice of this anti-prosthetic provision in the NPRM. The Department explicitly sought comment in its October 2005 NPRM (70 FR 62281) on whether collectors should check to make sure that employees providing a specimen under DO are not using a prosthetic or other device to cheat on the test (e.g., by having an employee lower his pants and underwear so that the collector or observer could determine whether the employee was using such a device). This notice fully meets the requirement of the Administrative Procedure Act (APA) for a meaningful participation from the public by fairly apprising interested persons of the issues in the rulemaking. While DOT and agencies commonly do publish proposed rule text, there is no statutory requirement in the APA to do so, and doing so is not a mandatory prerequisite to issuing a final rule. A ``description of the subjects and issues involved'' (5 U.S.C. 553(b)(3)) is sufficient. That the notice did provide interested persons a meaningful opportunity to comment on this issue is evidenced by the comments that the Department in fact received. In the preamble to the Department's final rule based on this NPRM (73 FR 35968), the Department responded to comments on this proposal. This response set forth the Department's rationale for adopting the new provision, found in section 40.67(i), requiring employees to raise and lower their clothing to show the collector or observer that the employee does not possess a prosthetic or other device designed to beat the test. The Department has fully explained in regulation text, guidelines, and supportive materials that the devices subject to the new procedures would be those expressly designed to interfere with the collection process (e.g., designed to carry ``clean'' urine or urine substitutes into the collection site). Likewise, our guidelines have always had provisions for those employees whose medical conditions require them to provide urine via indwelling catheters or external urine bags. Comments Favoring Mandatory Direct Observation Testing on Return-to- Duty and Follow-Up Tests The Department received 29 comments favoring the concept of DO collections in general and/or the mandatory application of DO to follow-up and return-to-duty testing. The [[Page 62914]] majority of these comments were from SAPs, though a few collection sites, a testing industry association, an MRO, an employer, and a few individuals took this view as well. The common theme among these commenters was that conducting direct observations on return-to-duty and follow-up tests is important to safety. SAP commenters generally said, based on their personal experience of working with individuals who had failed or refused drug tests, that people with addiction or other substance abuse problems had a great deal of difficulty in changing their behavior. They often exhibit denial of their problems and have a powerful drive to cheat in order to continue using the substances to which they are attached while continuing to work. One of the SAPs commented that for an individual who had failed or refused a drug test, being subject to DO and a return-to-duty or follow-up test is a consequence of substance abuse problems and/or a violation of Federal law, and as such was justified. Some commenters pointed to the fact that many treatment programs use direct observations for their own testing during rehabilitation, so many who have undergone treatment would expect direct observations. A number of SAPs indicated that when they recommended DO, employers responded by saying they would not have employees observed. Some employers were alleged to have stopped using SAPs who made these recommendations. In essence, SAPs said that employers were undermining the entire purpose of having the DO option. For this reason, one SAP recommended that any violation related to an employee's attempt to beat the test by adulteration, substitution, or other refusal should be met with long-term, if not permanent, removal from safety sensitive duties. The collection site organization that commented noted that DO collections make up a very small number of all DOT tests and can be an effective deterrent against cheating on return-to-duty and follow-up tests. One SAP commented that making DO mandatory in the return-to-duty and follow-up contexts would counteract what he viewed as hesitancy on the part of many employers under the present discretionary rule. This timidity, in his view, has led to a significant amount of cheating on these tests. Finally, some employer associations, while objecting to making DO mandatory for all follow-up and return-to-duty tests, supported requiring DO when the follow-up and return-to-duty tests resulted from a refusal to test, as distinct from a positive test. DOT Response The Department believes that the expertise of SAPs--the individuals in the drug testing system who most often have first-hand, day-to-day observation of the individuals who violate DOT drug testing rules and the behaviors and motivations of these individuals--carries a great deal of weight in this discussion. They are the ``Gatekeepers'' of the return-to-duty process. SAPs have the education, qualifications, and experience that vest them with a significant role in evaluation, treatment, return-to-duty recommendations, and follow-up testing plans of the individuals who have violated Part 40 through their refusals and/or positive test results. Their nearly unanimous view that DO collections, particularly in the context of return-to-duty and follow- up testing, is a necessary and appropriate response to the predictable behaviors of many violators strongly supports the Department's view that there is a heightened risk of cheating by individuals who are seeking to reclaim or retain the ability to perform safety-sensitive work after a violation. We also agree with SAPs who pointed out that individuals in recovery often need support to help them in their efforts to remain abstinent from drugs. They point out that people with substance abuse problems or who suffer from addiction are prone to having problems dealing with their drug use and in changing their drug use behavior, even after rehabilitation. In short, these employees are prone to relapse into drug use. We agree with SAPs who believe that DO collections would help these employees in their struggle to stop drug use. We also agree with SAPs comments indicating that drug treatment and education programs require DO collections during their program efforts. Therefore, most employees coming back into the workplace after testing positive or refusing a DOT test would be accustomed to having their collections observed. Employees who fail or refuse a drug test, and who are offered the opportunity by their employer to return to work, are frequently covered by a ``last chance agreement,'' a ``two strikes and out'' policy that means that a second violation will result in the individual being fired. In the aviation industry, the statutory ``permanent bar'' means that employees who fail a second test will never work in a particular occupation again. Where an individual cannot resist the powerful pull of drug dependence, and realizes that a positive result can cost him or her a job or even a career, cheating using one of the readily available techniques can prove an attractive option. We agree with the point that tests requiring DO collections make up only a small percentage of all DOT drug tests, and hence do not affect the vast majority of workers who take and pass DOT drug tests. We want to correct the misunderstanding of some commenters, who appeared to believe that all DOT tests would be directly observed under the new rules. To the contrary, people taking pre-employment, random, reasonable suspicion, and post-accident tests are not subject to DO, unless their actions trigger a suspicion that they are trying to cheat. The only workers who are affected by DO testing are those who by their conduct at the collection site or by the results of their tests have demonstrated that they are willing to endanger public safety through violating Federal law prohibiting illegal drug use. As a joint comment from two employer associations noted, the propensity to avoid accountability for drug use is particularly marked among individuals who refuse to take a drug test. Comments Opposing Mandatory Direct Observation Testing on Return-to- Duty and Follow-Up Tests Sixteen commenters, including several unions and a number of individuals, opposed DO in general. They said it was too intrusive, violated employees' privacy, and would work a particular hardship on people who had anxiety disorders that made it difficult for them to urinate when someone was watching. A number of union commenters also said that they believed that expanding the scope of mandatory DO testing to all follow-up and return-to-duty tests would exceed the Department's constitutional authority as outlined in the 1989 Supreme Court case (Skinner v. Railway Labor Executives' Association, 489 U.S. 602 (1989)) that upheld the constitutionality of Federal Railroad Administration (FRA) drug testing requirements applying to the rail industry. In addition, some of these comments cited the provision of the Omnibus Transportation Employee Testing Act of 1991 directing the Department to ``promote, to the maximum extent practicable, individual privacy in the collection of specimens'' (see 49 U.S.C. 31306(c)(1) and parallel sections). Three unions suggested that DO testing was not needed for return- to-duty and follow-up tests because employees who had tested positive had, in effect, shown themselves to be [[Page 62915]] willing to submit to testing without cheating. The unions reasoned that these employees were not the sort of people who had the motivation or propensity to cheat on tests. Moreover, one of the unions said, employees it represented must go through a detailed SAP evaluation process as well as vetting by DOT before returning to duty, so are likely to be drug-free. One of the most frequent comments made by commenters opposing the mandatory use of DO for return-to-duty and follow-up tests was that there was insufficient evidence of the need to take this step. Sixteen comments, mostly from unions and some employer groups, took this view. One union said that the low overall violation rate and the small number of recorded cases of adulteration and substitution showed that DO collections were not needed. In addition, the commenter said, individuals had shown a SAP that they were successfully rehabilitated by the time they got to the follow-up test stage of the process. Four other unions said that there was no evidence demonstrating a higher level of adulterated or substituted tests in the return-to-duty and follow-up contexts, and there was no documentation that transportation employees actually used prosthetic and other cheating devices, or that DOT agency personnel had not seen evidence of cheating. Eleven commenters, among which were unions, employers or employer associations, and collection sites or TPAs, urged the Department to retain the existing rule that makes the use of DO an employer option in the follow-up and return-to-duty contexts. One union said that DO should not be required for follow-up and return-to-duty tests unless there were specific findings or medical determinations backing the requirement for a given employee. Two other unions suggested that SAPs were in a good position to determine when DO was appropriate for an individual subject to return-to-duty and follow-up tests, and their findings could be a basis for such a decision. Another union suggested that the employer's designated employer representative (DER) could appropriately make this decision. On the other hand, two unions and a collection site operator said that, under existing DOT rules and guidance, DERs had too much discretion to direct that a test be conducted under DO. Twelve commenters, mostly collection sites, expressed the concern that they would be unable to find enough people to act as observers. The rule requires observers to be the same gender as the employee being tested, they noted, and their experience was that most or all collection site personnel were women while most employees reporting for testing were men. Seven commenters said that making DO mandatory in follow-up and return-to-duty testing would significantly increase the total number of DO collections. One employer association said that of the approximately 4000 such tests in its industry, employers found it necessary to use DO only rarely. A large employer said it chose to use DO in only a small number of the approximately 1200 return-to-duty and follow-up tests it administered per year. Another employer association predicted that the number of DO collections would double. A union projected that there would be a dramatic increase in the number of employees subject to DO tests and the number of such tests conducted, if all follow-up and return-to-duty tests are directly observed. Some commenters said that there would be increased costs, since in many cases a second person, other than the collector, would have to be paid to observe the tests. Five commenters, including a TPA, two collection sites, an employer, and an individual, said they feared that mandatory DO in follow-up and return-to-duty testing would lead to a decrease in the availability of collection facilities. Two commenters said that the prospect of additional costs had already persuaded a few collection sites to stop doing DOT testing. In other comments, a TPA expressed concern that mandatory DO would lead employers to fire people rather than giving them a chance to return to work, because of extra costs of DO testing. A collection site said that only medical personnel should be observers in DO collections, while another collection site organization said that employer representatives should be able to act as observers. DOT Response The Department agrees with commenters that DO collections are intrusive. The Department's rule has always recognized that there is a subset of cases in which this intrusion is justified in the interests of program integrity and public safety. When employees' conduct at the collection site shows the likelihood of an attempt to tamper with a specimen, when unexplained invalid test results come back from the laboratory, or when employees test positive or refuse to take a test, the Department's regulations have always recognized that there is a higher risk of cheating and a higher risk to safety. In these situations, the Department's existing rules require or permit the use of DO testing in order to deter and/or detect attempts to cheat. The Supreme Court's decision in Skinner held that the FRA's post- accident drug testing program for railroad employees was constitutional, notwithstanding the absence of individualized suspicion of drug use by employees subject to testing. A companion case (National Treasury Employees' Union v. Von Raab, 489 U.S. 656 (1989)) concerning the testing of Federal customs personnel and a subsequent case concerning the Federal Aviation Administration's (FAA) drug testing program (Bluestein v. Skinner, 908 F.2d 451 (9th Cir., 1990), cert. denied 498 U.S
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