{"operation":"document","citation":"88 FR 27596","title":"Procedures for Transportation Workplace Drug and Alcohol Testing Programs: Addition of Oral Fluid Specimen Testing for Drugs","source_type":"rulemaking","agency":"Federal Transit Administration","status":"historical","official":true,"published_on":"2023-05-02","effective_on":"2023-06-01","summary":"This final rule amends the U.S. Department of Transportation's regulated industry drug testing program to include oral fluid testing. This additional methodology for drug testing will give employers a choice that will help combat employee cheating on urine drug tests and provide a less intrusive means of achieving the safety goals of the program. In order for an employer to implement oral fluid testing under the Department's regulation, the U.S. Department of Health and Human Services will need to certify at least two laboratories for oral fluid testing, which has not yet been done. The final rule includes other provisions to update the Department's regulation and to harmonize, as needed, with the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid established by the U.S. Department of Health and Human Services. In addition, this rule amends the FAA, FMCSA, FRA and FTA regulations to ensure consistency within the Department of Transportation and by removing or adjusting references to the word \"urine\" and/or add references to oral fluid, as well as removing or amending some definitions for conformity and to make other miscellaneous technical changes or corrections.","machine_formats":{"json":"https://regulus.evalyn.ai/document/federal-register-2023-08041.json","markdown":"https://regulus.evalyn.ai/document/federal-register-2023-08041.md"},"app_url":"https://regulus.evalyn.ai/document/federal-register-2023-08041","source_url":"https://www.federalregister.gov/documents/2023/05/02/2023-08041/procedures-for-transportation-workplace-drug-and-alcohol-testing-programs-addition-of-oral-fluid","body":"Federal Register, Volume 88 Issue 84 (Tuesday, May 2, 2023) [Federal Register Volume 88, Number 84 (Tuesday, May 2, 2023)] [Rules and Regulations] [Pages 27596-27653] From the Federal Register Online via the Government Publishing Office [ www.gpo.gov ] [FR Doc No: 2023-08041] [[Page 27595]] Vol. 88 Tuesday, No. 84 May 2, 2023 Part II Department of Transportation ----------------------------------------------------------------------- Federal Aviation Administration Office of the Secretary Federal Railroad Administration Federal Motor Carrier Safety Administration Federal Transit Administration ----------------------------------------------------------------------- 14 CFR Part 120 49 CFR Parts 40, 219, 240, et al. Procedures for Transportation Workplace Drug and Alcohol Testing Programs: Addition of Oral Fluid Specimen Testing for Drugs; Final Rule Federal Register / Vol. 88 , No. 84 / Tuesday, May 2, 2023 / Rules and Regulations [[Page 27596]] ----------------------------------------------------------------------- DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 120 Office of the Secretary 49 CFR Part 40 Federal Railroad Administration 49 CFR Parts 219, 240, and 242 Federal Motor Carrier Safety Administration 49 CFR Part 382 Federal Transit Administration 49 CFR Part 655 [Docket DOT-OST-2021-0093] RIN 2105-AE94 Procedures for Transportation Workplace Drug and Alcohol Testing Programs: Addition of Oral Fluid Specimen Testing for Drugs AGENCY: Office of the Secretary of Transportation (OST), Federal Aviation Administration (FAA), Federal Motor Carrier Safety Administration (FMCSA), Federal Railroad Administration (FRA), and Federal Transit Administration (FTA); U.S. Department of Transportation (DOT). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This final rule amends the U.S. Department of Transportation's regulated industry drug testing program to include oral fluid testing. This additional methodology for drug testing will give employers a choice that will help combat employee cheating on urine drug tests and provide a less intrusive means of achieving the safety goals of the program. In order for an employer to implement oral fluid testing under the Department's regulation, the U.S. Department of Health and Human Services will need to certify at least two laboratories for oral fluid testing, which has not yet been done. The final rule includes other provisions to update the Department's regulation and to harmonize, as needed, with the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid established by the U.S. Department of Health and Human Services. In addition, this rule amends the FAA, FMCSA, FRA and FTA regulations to ensure consistency within the Department of Transportation and by removing or adjusting references to the word ``urine'' and/or add references to oral fluid, as well as removing or amending some definitions for conformity and to make other miscellaneous technical changes or corrections. DATES: This final rule is effective on June 1, 2023. FOR FURTHER INFORMATION CONTACT: For OST, Patrice M. Kelly, JD, Office of Drug and Alcohol Policy and Compliance, 1200 New Jersey Avenue SE, Washington, DC 20590; telephone number 202-366-3784; [email protected] . For FAA, Nancy Rodriguez-Brown, Deputy Director, Office of Aerospace Medicine, Drug Abatement Division, AAM-800, FAA, 800 Independence Avenue SW, Washington, DC 20591 (telephone: 202-267- 8442; [email protected] ). For FMCSA, Bryan Price, Chief, Drug and Alcohol Programs Division, Office of Safety Programs, FMCSA, 1200 New Jersey Avenue SE, Washington, DC 20590-0001 (telephone: 202-366-2995; email: [email protected] ). For FRA, Gerald Powers, Drug and Alcohol Program Manager, Office of Railroad Safety--Office of Program Management, FRA RRS-25, 1200 New Jersey Avenue SE, Washington, DC 20590-0001 (telephone: 202-493-6313; email: [email protected] ). For FTA, Iyon Rosario, Senior Drug and Alcohol Program Manager, Office of Transit Safety and Oversight (TSO), FTA, 1200 New Jersey Avenue SE, Washington, DC 20590-0001 (telephone: 202-366-2010; email: [email protected] ). SUPPLEMENTARY INFORMATION: I. Authority for This Rulemaking This rulemaking is promulgated under the authority originally enacted in the Omnibus Transportation Employee Testing Act (OTETA) of 1991, codified at 49 U.S.C. 45102 and 45104 (aviation industry testing), 49 U.S.C. 20140 (rail), 49 U.S.C. 31306 (motor carrier), and 49 U.S.C. 5331 (transit). OTETA requires that the Department incorporate the Department of Health and Human Services' (HHS) Mandatory Guidelines, including amendments, into the Department's regulations for testing and laboratory requirements for aviation, rail (except for rail post-accident testing),\\1\\ motor carrier, and transit testing. Additional authority at 5 U.S.C. 7301 note and Executive Order 12564, establish HHS as the agency that establishes scientific and technical guidelines for Federal workplace drug testing programs and standards for certification of laboratories engaged in such drug testing. While DOT has discretion concerning many aspects of its regulations governing testing in the transportation industries' regulated programs, DOT follows the HHS Mandatory Guidelines for the laboratory and specimen testing procedures. --------------------------------------------------------------------------- \\1\\ As will be discussed further below, post-accident toxicological testing conducted under FRA authority is not subject to the OTETA mandate and therefore does not follow Part 40 procedures. See 49 U.S.C. 20140(f), 40.1(c), 219.205(a), and 219.701(a)-(b). --------------------------------------------------------------------------- On October 25, 2019, HHS published a final rule establishing the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG), which became effective January 1, 2020. (84 FR 57554, Oct. 25, 2019). As of the time of the publication of this final rule, there have been no laboratories yet certified by HHS for oral fluid testing. II. Background On November 21, 1988, the Department first published its drug testing program regulation, ``Procedures for Transportation Workplace Drug and Alcohol Testing Programs'', part 40 of Title 49 of the Code of Federal Regulations (part 40), as an interim final rule (53 FR 47002). The Department based the scientific requirements in that rule on the 1988 HHS Mandatory Guidelines for Federal Agency Employee Drug Testing Programs (53 FR 11970, Apr. 11, 1988), which set forth the scientific procedures for laboratories to analyze urine specimens for the presence of specified drugs at the HHS-required cutoff levels for the initial and confirmation tests for each specific drug in urine testing. These cutoff levels for urine were established at levels to show use of the specified prohibited drugs. When the Department adopted its first drug testing final rule, we established a procedure for urine collections generally to take place with visual and aural privacy afforded to each employee, unless suspicious activity under 49 CFR 40.25(f)(14), (16) and (23) called for a direct observed collection (i.e., body-to-bottle observation). (53 FR 47002, Nov. 21, 1988). In December 2000, the Department comprehensively rewrote part 40 into plain language. The direct observation provisions for urine were placed in 49 CFR 40.67, with the body-to-bottle observation requirement remaining unchanged. (65 FR 79462, Dec. 19, 2000). Urine collections of private citizens are potentially invasive searches and seizures subject to scrutiny under the Fourth Amendment of the United States Constitution. Consequently, the Department has always approached the collection of urine from transportation safety-sensitive employees with a [[Page 27597]] concern for employee privacy, which must be balanced carefully against the Department's need to protect transportation safety. The Department protects individual rights by ensuring privacy for employees undergoing urine testing. Allowing directly observed urine collections only for ``cause'' (e.g., suspicious activity at the collection site, previous violations, or irregularities determined by the laboratory testing of a specimen), but not for all urine collections under part 40, is another protection for employees undergoing testing. In June 2008, the Department strengthened direct observation collection requirements to include more effective observation procedures and expanded the circumstances that would warrant a direct observation procedure to address cheating on drug tests. (73 FR 35961, Jun. 25, 2008). Although the 2008 final rule was challenged in court and initially stayed, the stay was lifted, and the final rule was reinstated. (74 FR 37949, Jul. 30, 2019). The United States Court of Appeals for the District of Columbia Circuit unanimously affirmed the Department's enhanced direct observation procedures to prevent the use of prosthetic devices used for cheating and to expand direct observation to tests of people who had already violated the rules (e.g., return-to-duty and follow-up tests for persons who had tested positive or refused to test). See BNSF Railway Company v. Department of Transportation, 566 F.3d 200 (D.C. Cir. 2009). Before the Department's move to expand the direct observation procedures, HHS was aware of the potential for cheating on urine tests and had begun its own rulemaking to explore alternative testing methods. In 2004, HHS solicited public comment on the following alternative testing methods, all of which would be directly observed: oral fluid, hair, and sweat testing. (69 FR 19673, Apr. 13, 2004). HHS stated: ``Addition of these specimens to the Federal Workplace Drug Testing Program would complement urine drug testing and aid in combating the threat from industries devoted to subverting drug testing through adulteration, substitution, and dilution.'' (Id. at 19675). HHS noted that there were problems with all three of the proposed alternative matrices but asked for additional scientific information and sought information on appropriate levels for proficiency testing for these alternatives. While the science supporting oral fluid testing did not meet the standards of HHS in 2004, science and research studies have now reached the point where HHS has been able to determine that oral fluid testing is an appropriate alternate testing method for identifying illicit drug use in the Federal workplace. The scientific viability of oral fluid testing has greatly advanced since 2004 to the point where HHS determined, in 2019, that the methodology is accurate and appropriate for Federal employee testing. In its 2019 final rule, HHS stated that ``[t]he scientific basis for the use of oral fluid as an alternative specimen for drug testing has now been broadly established and the advances in the use of oral fluid in detecting drugs have made it possible for this alternative specimen to be used in Federal programs with the same level of confidence that has been applied to the use of urine.'' (84 FR 57554; Oct. 25, 2019). Importantly, HHS stated that its ``OFMG provide the same scientific and forensic supportability of drug test results as the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine. . . .'' Id. In evaluating the progress of science of oral fluid testing and its scientific viability, HHS also looked at its forensic defensibility in workplace testing. Specifically, in its preamble to the OFMG, HHS addressed concerns about passive exposure as the result of someone else's drug use (e.g., from second-hand smoke) in the context of cutoffs or metabolites used in oral fluid testing, particularly with regard to marijuana. (84 FR 57557, 57558; Oct. 25, 2019). HHS concluded that a 4 ng/mL screening test cutoff for THC would detect marijuana use while eliminating possibilities of positive tests resulting from passive exposure, as directed by the SUPPORT for Patients and Communities Act, Public Law 115-271, Sec. 8107(b). (See 84 FR at 57558; Oct. 25, 2019). We recognize directly observed urine specimen collections have long been the most effective method for preventing individuals from cheating on their drug tests by substituting or adulterating their specimens, but directly observed urine collection may only be done in certain circumstances due to employee privacy concerns (see 49 CFR 40.67). All oral fluid collections are directly observed because they are always collected in front of the collector. Unlike a directly observed urine collection, an oral fluid collection is much less intrusive on the tested employee's privacy. Therefore, adding oral fluid testing as an option is consistent with the careful balancing of an individual's right to privacy with the Department's strong interest in preserving transportation safety by deterring illicit drug use. OTETA specifically requires the Department to follow the HHS Mandatory Guidelines, which are the scientific and technical guidelines that establish comprehensive standards for all aspects of laboratory- controlled substances testing to ensure full reliability and accuracy in testing. Consequently, the Department published a notice of proposed rulemaking (NPRM) that proposed to revise part 40 to add the oral fluid testing procedures to its existing urine drug testing procedures for safety-sensitive transportation employees subject to drug testing under part 40 (hereinafter referred to as ``employees''). (87 FR 11156; Feb. 28, 2022). In response to public comments requesting an extension of the comment period, we provided additional time through April 29, 2022. (87 FR 16160; Mar. 22, 2022). Like HHS in its OFMG, we proposed, and are now including in this final rule, the option for employers to use either urine or oral fluid testing (except for FRA post-accident toxicological testing).\\2\\ By providing the option for an employer to choose collecting an oral fluid specimen or a urine specimen, DOT is broadening options for the testing of safety-sensitive employees in the transportation industries. --------------------------------------------------------------------------- \\2\\ Because FRA post-accident toxicological testing requirements in part 219, subpart C are not subject to the OTETA mandate and do not follow Part 40 procedures, this rule does not allow oral fluid testing for FRA post-accident toxicological testing, which still requires urine and blood specimens, as well as body fluid and tissue specimens for post-mortem tests. See Sec. Sec. 40.1(c), 219.203(a)(1), 219.205(a), and 219.207(a). --------------------------------------------------------------------------- Importantly, in order for an employer to implement oral fluid testing there must be at least two HHS-certified laboratories for oral fluid testing. There must be one HHS-certified laboratory to conduct the screening and confirmation drug testing on the primary specimen. There must be a different HHS-certified laboratory to conduct the split specimen drug testing on the secondary specimen, if the employee requests split specimen testing for a non-negative result. As of the date of the publication of this final rule, HHS has not yet certified any laboratories to conduct oral fluid testing. The following is a link to HHS-certified laboratories: https://www.samhsa.gov/workplace/drug-testing-resources/certified-lab-list As a reminder, if the employee requests the testing of their split specimen and there is not a second HHS-certified laboratory to test it, then the positive/adulterated/ substituted test result would be cancelled per Sec. 40.187(e) because there [[Page 27598]] would not be a way for the employee to have their split specimen tested and this would undermine the fairness and accuracy of the underlying test. Thus, for the reasons set forth above, oral fluid testing under part 40 cannot be fully implemented until HHS certifies at least two laboratories. The Department has amended some provisions of part 40 to harmonize with pertinent sections of the urine and oral fluid HHS Mandatory Guidelines. We have clarified certain existing part 40 provisions that cover the handling of urine specimens, removed provisions that are no longer necessary (such as erroneous compliance dates), added clarifying language to other provisions (such as updated definitions and web links where necessary), and modified a few substantive provisions to address issues that have arisen in practice (such as whether a test cancelled by a medical review officer (MRO) can ever be uncancelled, and whether a Substance Abuse Professional (SAP) can conduct evaluations virtually and across State lines). We have also modified some proposed revisions and added some new provisions to part 40, in response to public comments. This final rule also makes changes to the regulations of some DOT agencies, to ensure harmonization within the Department with the part 40 regulation. There were 417 commenters, most of whom provided multiple substantive and valuable points within each comment. The Department appreciates the time and effort the commenters expended in providing literally thousands of meaningful points. As we explained in our final rule in December of 2000, what matters the most is not a count of how many commenters favored or opposed a particular proposal. Instead, the Department's ``central concern is with the substance of the comments. In discussing comments on this rule and our response to them, we will focus on the substance of positions that commenters expressed, and on why we did or did not make changes in response to various comments.'' (65 FR 79462, Dec. 19, 2000). Similarly, in this preamble, with thousands of substantive comments, we have not ``counted the number of comments supporting a given position except in the most general way, believing that doing so would distract from the discussion of substantive issues.'' Id. However, we have attempted to meaningfully address all comments, including the questions and concerns expressed therein. As the final part of this Background section, we are providing readers with a Redesignation Table to provide what sections in the existing part 40 are changing and what their new redesignations are. Redesignation Table Beginning with subpart D (see below), the Department is redesignating (i.e., renumbering and reordering) numerous sections of part 40 to provide a more easily followed flow for users of the regulation provisions specific to oral fluid drug testing. Redesignations of Sections in Part 40 ------------------------------------------------------------------------ Old section New section ------------------------------------------------------------------------ 40.35..................................... 40.36. 40.41..................................... 40.42. 40.45..................................... 40.40. 40.47..................................... 40.41. 40.49..................................... 40.44. 40.51..................................... 40.45. 40.73..................................... 40.79. 40.85..................................... 40.82. 40.87..................................... 40.85. 40.89..................................... 40.86. 40.91..................................... 40.87. 40.93..................................... 40.88. 40.95..................................... 40.89. 40.96..................................... 40.90. 40.99..................................... 40.84. Appendix B................................ Appendix D. Appendix C................................ Appendix E. Appendix D................................ Appendix F. Appendix E................................ Appendix G. Appendix F................................ Appendix H. Appendix G................................ Appendix I. Appendix H................................ Appendix J. ------------------------------------------------------------------------ III. Principal Policy Considerations Oral Fluid as an Alternate Drug Testing Method for Workplace Testing When the HHS finalized its OFMG in 2019, it opened oral fluid testing to Federal agencies as an alternate methodology to choose and not as a replacement for urine drug testing. Similarly, the Department has determined that oral fluid testing will be an option for regulated employers and not a replacement for urine testing. The commenters expressed many different opinions on whether oral fluid testing should be mandated in some or all circumstances; whether it should be purely the employer's choice; whether it should be the employee's choice; and whether it should be the collector's choice. There were suggestions to allow only oral fluid testing for reasonable suspicion and post-accident testing. Some commenters wanted to see oral fluid testing prohibited for pre-employment and random testing because they preferred the potentially longer windows of detection of urine versus oral fluid testing. Individuals who were concerned with paruresis wanted the employee to be able to choose oral fluid for every test and some of those commenters wanted urine testing banned. Some commenters were concerned that, if we mandated oral fluid testing in any circumstances, then every collector would need to be trained in oral fluid collections and every collection site would need to purchase oral fluid testing kits at an additional expense to such small businesses. The commenters who opposed oral fluid testing generally said they were concerned that oral fluid specimens would be used for DNA testing, or the commenters wanted drug testing of safety sensitive employees to stop. As discussed earlier, HHS has determined oral fluid drug testing, like urine drug testing, is accurate and defensible. With both drug testing methodologies being scientifically accurate and forensically defensible, there is no reason to eliminate either methodology. Similarly, we see no reason to mandate either methodology. However, we will discuss below, in reference to problem collection scenarios covered by Sec. 40.67 (direct observation collections) and Sec. 40.193 (insufficient specimen ``shy bladder'' cases), that we strongly suggest employers consider moving to an oral fluid testing methodology. Employers should communicate to their consortium/third party administrator (C/TPA) and to their collection sites whether they want to utilize urine testing, oral fluid testing, or some combination of both. Employers should also provide their service agents with the specific instances that would trigger a different methodology (e.g., an insufficient oral fluid collection should immediately become a urine collection or vice-versa). If we were to mandate an alternate methodology be used, but the collection kit was not available at the collection site, the test would likely not occur at that site. If no test occurs, that would not be in the best interest of safety. Those who commented that not every collection site will offer oral fluid testing have a valid point. It is possible a collection site will make a business decision not to offer oral fluid testing because of costs or training issues. Although it is the ultimate duty of the employer to ensure their collection sites are able and available to perform testing in accordance with part 40, it would be helpful for collections sites to notify their DOT-regulated clients that they will not offer oral fluid collections. It is also important to remember that under Sec. 40.209(b)(3), if an unqualified collector were to conduct a collection, it would not cancel the test. As we said in our 2000 preamble to Sec. 40.209, ``a test is [[Page 27599]] not invalidated because a collector has not fulfilled a training requirement. For example, suppose someone collects a specimen correctly but has not completed required training or retraining. The test would not be cancelled because the training requirement was not met.'' 65 FR 79472. To reflect this point, we have updated Sec. 40.209(b)(3) to add a reference to Sec. 40.35 for oral fluid collector training, in addition to the existing reference to Sec. 40.33 for urine collector training. Although it would not cancel the test result if the collector has not been trained in accordance with part 40, the collector, other service agents, and employer involved might be found in noncompliance as the result of the failure to meet training requirements. Since the inception of DOT-regulated alcohol testing in 1994, we have allowed screening testing to be conducted using saliva testing devices, and we have required all confirmation testing to be conducted on an evidential breath testing (EBT) device. See 49 CFR 40.231. A facility that conducts alcohol saliva screening but that does not have an EBT must work expeditiously with the employer to ensure that the confirmation test takes place on an EBT. Similarly, if a collection site only offers urine collections and an insufficient specimen is presented or if a direct observation collection is triggered, that collection site is expected to work expeditiously with the employer to ensure that the oral fluid collection occurs if the employer wants an oral fluid collection performed for an employee. Collection sites need to make business decisions about whether they will offer urine collections, oral fluid collections or both. Thus, not every collector needs to be trained on both urine and oral fluid collections unless they offer both. The Owner-Operator Independent Drivers Association (OOIDA) asked that we ``continue educating industry stakeholders about the scientific and forensic supportability of oral fluid testing . . . (and) about how oral fluid testing would be implemented and administered.'' OOIDA reminded us that State and local law enforcement execute roadside testing, and OOIDA wanted us to differentiate and address concerns in the trucking industry about the differences between roadside oral fluid drug tests and DOT's regulated laboratory tests. The Department will continue educating industry stakeholders, as we have always done, for urine testing and for part 40 compliance. Traditionally, State and local law enforcement have implemented their own testing entirely outside DOT-regulated drug testing and will continue to do so. Often, law enforcement entities have chosen point- of-collection testing (POCT) devices that provide initial screening test results, instead of laboratory-based screening testing. The POCT testing can cover the same drugs for which we test and more (or fewer) substances. The cutoff levels of the drugs being tested for in POCT devices differ widely among POCT devices. Thus, the differences are varying and may be significant. We will educate our regulated industries about DOT's regulated oral fluid testing alone. However, we welcome our industry partners to continue to educate their memberships about the differences they are encountering beyond DOT-regulated testing. In buffered collections, the employee's oral fluid is collected on a device and then the device is subdivided into Bottles A and B, which contain a buffering solution. The buffering solution draws the oral fluid from the device, so that the liquid can be analyzed by the laboratory for the drugs for which we test. OOIDA raised concerns about whether drugs sufficiently enter the buffering solution. In its oversight of laboratory testing under the OFMG, HHS sets the standards for the devices and recovery of drug from the same. These are assessed two times: first, by the manufacturer and second, during laboratory validation of the collection device. While HHS does not certify or validate the collection devices or the buffer, the NLCP laboratory inspection process does ensure accuracy of the results obtained by the laboratories as evidenced by each laboratory's method of validation documentation which must specify the collection device(s) used. HHS will approve each specific HHS-certified oral fluid laboratory to use only one or more specific devices for which the laboratory can ensure the accuracy of the results. For further discussion of this subject, see the HHS final rule on oral fluid testing at 84 FR 57559, 57584 (Oct. 25, 2019). Also, OOIDA stated they do not want hair testing in the DOT regulated program. It is important to note hair testing is outside the scope of this rulemaking, as we will discuss further in this preamble. Finally, in response to the commenters who opposed the proposal to allow oral fluid testing due to concerns about DNA information or who oppose the principle of drug testing of safety-sensitive employees, we disagree on both points. As for DNA testing, part 40 already prohibits the DNA testing of any specimen collected for a DOT-regulated test. In fact, this rulemaking proposed to update the prohibitions on DNA testing contained in Sec. Sec. 40.13(c) and (e) (now Sec. Sec. 40.13(c) and (f)) to ensure that they extend to oral fluid testing. As for the commenters who generally opposed drug testing, they offered no data to support why eliminating drug testing would be in the best interest of transportation safety. Instead, they merely said that transportation safety-sensitive employees should be permitted to use marijuana. However, it is important to remember that the beginning of DOT-regulated testing in 1988 was prompted by marijuana-related accidents that occurred in 1985 (two New York City subway accidents) and 1987 (one railroad accident in Chase, Maryland). Whether Using Oral Fluid Testing as an Alternate Method Can Reduce Costs In the proposal for this rulemaking, we stated that oral fluid testing is generally less expensive than urine testing. We said an oral fluid test can cost between $10 to $20 less than a urine test (e.g., about $50 for a typical urine testing process, vs. about $35 for an oral fluid testing process, with the largest part of the difference being attributable to the collection process). We asked for public comment on the costs of oral fluid testing as compared to urine testing to affirm or adjust this cost assumption. The majority of commenters on this point said the cost of an oral fluid test would be more expensive than a urine test, but that there were other, mostly unquantifiable benefits that oral fluid testing would bring. Specifically, those benefits included: eliminating the costs of shy bladder evaluations; alleviating the burden on individuals who cannot produce a sufficient urine specimen due to a psychological and/or physical medical condition; opening transportation safety- sensitive employment possibilities to many who have disabilities rendering them unable to produce an adequate urine specimen; and the thwarting of cheating. Many commenters said these benefits would outweigh the additional costs of conducting an oral fluid specimen collection. Several commenters who conduct non-DOT collections said laboratories currently conducting oral fluid testing charge about $4.00 per buffered collection device, versus urine collection devices that are provided at no charge. A number of commenters in the laboratory and manufacturing businesses explained the need to charge because the buffering solutions included [[Page 27600]] in the oral fluid collection tubes are an added expense. Urine specimen collection devices are empty plastic containers, with no solutions involved, and are thus less expensive to provide and need no Food and Drug Administration (FDA) approval. In addition, the oral fluid collection kits expire, often as soon as twelve months after manufacturing because of the limited shelf life of the buffering solution and sometimes the collection pads themselves, which are included in the collection kits. Collection sites noted that they not only pay the $4.00 per oral fluid collection kit, but then they must discard each kit that expires before it is used. Of course, urine collection kits do not expire. We proposed the use of a single oral fluid collection device that would be subdivided in the presence of the donor, as required by OTETA. Some commenters expressed appreciation that DOT would use a single device versus two separate devices. Those commenters noted that even if the single device were to be subdivided, it might cost more than $4.00, but was not likely to be the same expense as two separate kits at $4.00 each, which could have different expiration dates. Some commenters suggested the new devices would cost no more than $4.00 each, giving the new devices appeal in the non-DOT oral fluid market, also. They said the oral fluid device manufacturers and the laboratories would want to keep up with the DOT's requirements for DOT-regulated testing and they would not want to price themselves out of the market for non- DOT testing, since many in the non-DOT market would follow DOT's requirements, as they now do. We had a tremendous number of comments from individuals who have an inability to provide a sufficient quantity of urine due to a psychological condition known as paruresis. Individuals in this group told stories of losing their careers due to an inability to provide a sufficient quantity of urine. Others said they chose not to pursue transportation safety-sensitive careers because of the requirements of urine testing. Some commenters told of aspirations of becoming commercial truck drivers or airline pilots, once the perceived barrier of urine testing is removed. With the option of oral fluid testing methodology, these individuals emphasized their marketability in the transportation workplace would increase. While part 40 has a process for a medical evaluation to be conducted to determine if one's inability to provide urine is legitimate under Sec. 40.193, the commenters noted the process was arduous for them and expensive. In addition, such individuals often do not have a diagnosis of a pre-existing psychological condition that would substantiate their inability to provide a sufficient quantity of urine. We received comments from the International Paruresis Association (IPA), who thoroughly explained the condition of paruresis. The IPA and the individual commenters applauded DOT for proposing to allow oral fluid testing. Many asked for the Department to end urine testing or to allow employees to choose the methodology that would be used for their testing. By allowing the employee to choose the methodology, they believed those with paruresis could receive a reasonable accommodation without needing to disclose their disability to their respective employer or prospective employer. We asked for public comment about the number of shy bladder evaluations that are occurring and how much they cost. We did not receive any public comment to add clarity to those points. Overall, the commenters did not provide specific data on the numbers we sought clarification on through the public notice and comment process, but they did provide many comments about the qualitative improvements to DOT drug testing that would be added through the adoption of oral fluid testing. Consequently, we adjusted our approach to the economic analysis for this rule. Instead of the quantitative economic analysis we began in the NPRM, we have conducted a qualitative analysis for this final rule. As discussed above under Oral Fluid as an Alternate Methodology section, we have decided to make oral fluid testing available to employers as an alternate methodology to urine testing. We are not eliminating urine testing. We are including oral fluid testing as an option available to employers. Whether an oral fluid or urine test is administered is the employer's choice and not the choice of the employee, for the reasons explained in this preamble. Who will perform the oral fluid collection? Recognizing that employers often utilize the services of external qualified collectors for urine testing, we asked for comment as to whether this would continue for oral fluid testing, or if employers would train their own company personnel to become qualified collectors for oral fluid testing purposes. We also specifically asked if companies thought they would train internal personnel instead of contracting with external providers, whether this would this be due to costs, convenience or other reasons, and what would be the cost implications of the two approaches. The majority of commenters disagreed with the concept of employers conducting their own collections. The commenters cited concerns such as invasion of privacy by supervisors and a lack of professionalism if an employer's own staff conducted oral fluid collections. Other commenters said allowing a co-worker to conduct oral fluid collections would lead to fraud because an employee with a substance use disorder might influence the objectivity of a colleague who is collecting. Some employers said that they would not want to incur the training costs or liability for their corporate employees to conduct collections. Some commenters wondered if internal collectors would thwart the testing process so that their fellow employees would not test positive. A few external collectors worried that in-house collections would lead to less demand for external collectors, thereby driving up costs for those who still want to use external collectors. One collection company polled its clients and found that 90 percent of their clients would continue to use external collectors. Even those who favored internal collections agreed that there should be limitations on internal collectors within an employer's organization. They supported the proposal to make it clear that employees, relatives, and close friends of the employees cannot conduct collections, consistent with existing guidance in the Department's Urine Specimen Collection Guidelines, which can be found at: https://www.transportation.gov/odapc/urine-specimen-collection-guidelines . Interestingly, many of those commenters appeared not to realize that employers have been allowed to collect urine specimens in-house for more than 30 years. For example, some of the large employers in the transportation industries have on-site clinics and regularly conduct many urine collections, including those requiring direct observation collections. Thus, we were asking more about whether oral fluid collections would occur externally or in-house, and were separately proposing the existing constraints regarding employees, relatives, and close friends of the employees as we have in urine testing. We have amended Sec. 40.31 to separately specify the requirements for collectors of urine and oral fluid specimens, respectively. We have adopted wording to require oral fluid collectors to be qualified. The final rule clarifies that employees, relatives, and [[Page 27601]] close friends of the employees cannot conduct collections, consistent with existing guidance in the Department's Urine Specimen Collection Guidelines. Allowing Alternate Specimens Provides Flexibility to Employers The Department proposed to offer employers flexibility in the type of specimen they collect. This final rule provides flexibility to employers in most situations, although we strongly encourage employers to consider having an alternate methodology ready and available to plan for contingencies (e.g., an employee's inability to produce a sufficient specimen as a permanent, long-term, or short-term condition; direct observation urine collections that could be handled easily by switching to oral fluid testing; reasonable accommodation requests; etc.). In addition, when an employer offers both oral fluid and urine testing, this can afford flexibility and other benefits. For example, when an employer determines that a DOT post-accident or a reasonable cause/suspicion test is needed, an oral fluid collection could be done at the scene of the accident or the workplace without the need to provide access to a bathroom. Oral fluid testing all","truncated":true,"body_characters":416086}