# Procedures for Transportation Workplace Drug and Alcohol Testing Programs: Addition of Oral Fluid Specimen Testing for Drugs

- **operation:** document
- **citation:** 87 FR 11156
- **title:** Procedures for Transportation Workplace Drug and Alcohol Testing Programs: Addition of Oral Fluid Specimen Testing for Drugs
- **source type:** rulemaking
- **agency:** Office of the Secretary
- **status:** proposed
- **official:** true
- **published on:** 2022-02-28
- **effective on:** Not available
- **summary:** The U.S. Department of Transportation is proposing to amend the transportation industry drug testing program procedures regulation to include oral fluid testing. This will give employers a choice that will help combat employee cheating on urine drug tests and provide a more economical, less intrusive means of achieving the safety goals of the program. The proposal includes other provisions to update the Department's regulation, and to harmonize, as needed, with the new Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid established by the U.S. Department of Health and Human Services.
- **machine formats:** - **json:** https://regulus.evalyn.ai/document/federal-register-2022-02364.json
- **markdown:** https://regulus.evalyn.ai/document/federal-register-2022-02364.md
- **app url:** https://regulus.evalyn.ai/document/federal-register-2022-02364
- **source url:** https://www.federalregister.gov/documents/2022/02/28/2022-02364/procedures-for-transportation-workplace-drug-and-alcohol-testing-programs-addition-of-oral-fluid
**body:**

Federal Register, Volume 87 Issue 39 (Monday, February 28, 2022) [Federal Register Volume 87, Number 39 (Monday, February 28, 2022)] [Proposed Rules] [Pages 11156-11186] From the Federal Register Online via the Government Publishing Office [ www.gpo.gov ] [FR Doc No: 2022-02364] [[Page 11155]] Vol. 87 Monday, No. 39 February 28, 2022 Part II Department of Transportation ----------------------------------------------------------------------- 49 CFR Part 40 Procedures for Transportation Workplace Drug and Alcohol Testing Programs: Addition of Oral Fluid Specimen Testing for Drugs; Proposed Rule Federal Register / Vol. 87 , No. 39 / Monday, February 28, 2022 / Proposed Rules [[Page 11156]] ----------------------------------------------------------------------- DEPARTMENT OF TRANSPORTATION Office of the Secretary 49 CFR Part 40 [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, U.S. Department of Transportation (DOT). ACTION: Notice of proposed rulemaking. ----------------------------------------------------------------------- SUMMARY: The U.S. Department of Transportation is proposing to amend the transportation industry drug testing program procedures regulation to include oral fluid testing. This will give employers a choice that will help combat employee cheating on urine drug tests and provide a more economical, less intrusive means of achieving the safety goals of the program. The proposal includes other provisions to update the Department's regulation, and to harmonize, as needed, with the new Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid established by the U.S. Department of Health and Human Services. DATES: Comments to the notice of proposed rulemaking should be submitted by March 30, 2022. Late-filed comments will be considered to the extent practicable. ADDRESSES: To ensure that you do not duplicate your docket submissions, please submit them by only one of the following means: Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for submitting comments. Mail: Docket Management Facility, U.S. Department of Transportation, 1200 New Jersey Ave. SE, West Building Ground Floor Room W12-140, Washington, DC 20590-0001. Hand delivery: West Building Ground Floor, Room W-12-140, 1200 New Jersey Ave. SE, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The telephone number is 202-366-9329. Instructions: To ensure proper docketing of your comment, please include the agency name and docket number DOT-OST-2021-0093 or the Regulatory Identification Number (RIN), 2105-AE94 for the rulemaking at the beginning of your comments. All comments received will be posted without change to http://www.regulations.gov , including any personal information provided. FOR FURTHER INFORMATION CONTACT: 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] . SUPPLEMENTARY INFORMATION: I. Purpose The Department of Transportation (DOT) is issuing this notice of proposed rulemaking (NPRM) to revise part 40 of title 49 of the Code of Federal Regulations (Part 40), ``Procedures for Transportation Workplace Drug and Alcohol Testing Programs'' to add the oral fluid testing procedures to the existing urine drug testing procedures for safety-sensitive transportation employees subject to drug testing under Part 40 (hereinafter referred to as ``employees''). This action is based on the Department of Health and Human Services' (HHS) establishment of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG) for Federal workplace drug testing programs. HHS determined that oral fluid testing conducted in accordance with the OFMG provides ``the same scientific and forensic supportability of drug test results as the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine . . . .'' (84 FR 57554). The OFMG final rule was published on October 25, 2019, and became effective January 1, 2020. In addition to adding oral fluid as a drug testing method and harmonizing with pertinent OFMG sections, we also propose to clarify certain Part 40 provisions that cover urine drug testing procedures; to remove provisions that no longer are necessary; to add clarifying language to other provisions such as updated definitions and web links, as appropriate; and to update provisions to reflect issues that have arisen in recent practice. II. 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 HHS Mandatory Guidelines, including amendments, into the Department's regulations for testing and laboratory requirements for aviation, rail, 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. Effective January 1, 2020, the OFMG allowed the option to use oral fluid specimens for Federal drug testing. As described in the OFMG rulemaking, the advantage of every oral fluid collection is that it will be directly observed, as opposed to most urine collections, which are unobserved. While 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, directly observed urine collection may only be done in certain circumstances due to employee privacy concerns (see 49 CFR 40.67). Unlike directly observed urine collections, an oral fluid collection is much less intrusive on the tested employee's privacy. By providing the option of collecting an oral fluid specimen, DOT is broadening options for the testing of safety-sensitive employees in the transportation industries. As discussed below, oral fluid collection can also reduce costs of compliance with Part 40. III. Background On November 21, 1988, the Department first published its drug testing program procedures regulation, 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 prohibited use of the specified 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) (53 FR 47002, Nov. 21, 1988) called for [[Page 11157]] a direct observed collection (i.e., body-to-bottle observation). In December of 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 are potentially invasive searches and seizures of private citizens, 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 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 visual and aural privacy for employees undergoing urine testing. Allowing directly observed collections only for ``cause'' (i.e., suspicious activity at the collection site or as determined by the laboratory testing of a specimen) is another protection. Yet, because the vast majority of DOT-regulated urine drug collections are unobserved, the program remains vulnerable to cheating by employees at the collection site, which can result in adulteration or substitution. In June 2008, the Department added provisions to strengthen directly observed 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, June 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, July 30, 2019). This action was based on the unanimous decision of the United States Court of Appeals for the District of Columbia Circuit. The court's decision 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 upon 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 a point where HHS is able to determine that oral fluid testing is an appropriate alternative testing method for identifying illicit drug use in the Federal workplace. As such, HHS proposed adding oral fluid testing to the Federal employee workplace testing program (80 FR 28054, May 15, 2015) and finalized this proposal, which became effective for Federal employee workplace testing on January 1, 2020 (84 FR 57554, Oct. 25, 2019). The Department is proposing to add oral fluid testing as an alternative testing method because, as noted above, it has been determined by HHS to be scientifically viable for Federal workplace programs and because it provides a directly observed collection for every test. The collection of oral fluid is less invasive than directly observed urine collection and, therefore, 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. The Department's testing statutes specifically require that the Department incorporate the HHS Mandatory Guidelines, which are scientific and technical guidelines that ``establish comprehensive standards for all aspects of laboratory-controlled substances testing'' to ensure full reliability and accuracy in testing. Because HHS has published its final OFMG, thereby approving oral fluid testing as a reliable means of detecting illicit drug use for Federal employees, the Department is proposing to allow, but not require, oral fluid specimen testing as an alternative method under Part 40, for use by DOT- regulated employers for required transportation industry workplace testing. Specifically, we are seeking comments as to whether there are circumstances where either urine or oral fluid should be mandatory. We are also proposing to amend some of our provisions that pertain to both urine and oral fluid testing to harmonize with pertinent sections of the urine and oral fluid HHS Mandatory Guidelines. We are proposing to clarify certain existing Part 40 provisions that cover the handling of urine specimens, remove provisions that are no longer necessary (such as erroneous compliance dates), add clarifying language to other provisions (such as updated definitions and web links where necessary), and modify 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) should be allowed to conduct evaluations virtually). IV. Principal Policy Considerations Oral Fluid as an Alternative Drug Testing Method for Workplace Testing Since 2004, when HHS previously considered oral fluid testing, the scientific viability of that testing has advanced. 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 its 2019 OFMG, HHS recognized that products have emerged that can help people to adulterate a urine specimen. HHS emphasized that establishing oral fluid as a testing method would allow Federal agencies greater flexibility to address testing needs while minimizing the opportunity for specimen adulteration or substitution. (84 FR 57554, 57571; Oct. 25, 2019). Adulterating and substituting unobserved urine specimens is not a new issue to drug testing. In upholding the Office of Drug and Alcohol Policy and Compliance's (ODAPC) 2008 final rule allowing additional direct observation procedures, the U.S. Court of Appeals for the District of Columbia Circuit recognized the ``cheating'' problem: ``especially in light of [[Page 11158]] evidence of a growing proliferation of products that facilitate cheating on drug tests, the Department solicited comment on additional procedures to strengthen testing integrity.'' BNSF Railway v. US Department of Transportation, 566 F.3d at 202. In the BNSF court case, the D.C. Circuit upheld directly observed urine collections under the specific circumstances imposed by the Department because of the imminent threat of individuals cheating on drug tests. The court acknowledged that ``the Department determined that it was `not practicable' to ignore the cheating problem.'' Id. at 204. The court also accepted that oral fluid testing was not an acceptable method because HHS had not yet approved any specimen testing except urine. Id. at 205. With all of this considered, the court upheld the Department's direct observation procedures. Id. at 208-209. If the proposal to allow oral fluid testing is adopted, we could allow the use of oral fluid testing in lieu of observed urine tests to assist in addressing the cheating problem acknowledged in the BNSF case. While the Department does not have data on how much cheating is occurring, the problem exists and poses a direct threat to transportation safety. The court in BNSF noted: ``Acknowledging that it had no statistics on the rates of actual use of such devices, the Department inferred their use from the anecdotal evidence of their availability.'' Because the successful use of a cheating device would produce a negative drug test result, this would not show up in statistical reports as ``cheating.'' Thus, the court agreed with DOT that ``it was `illogical' to require statistical evidence of cheating. Given that people presumably buy cheating devices to use them, we think this approach quite reasonable . . .'' Consequently, the court recognized that the DOT could not base the rulemaking on statistical data on cheating. The court concluded, `` `It is one thing to set aside agency action under the Administrative Procedure Act because of failure to adduce empirical data that can readily be obtained. It is something else to insist upon obtaining the unobtainable. BNSF, 566 F.3d at 204 (internal citations omitted)). The Department recognizes that the court upheld directly observed urine tests in specific circumstances covered in the regulation. In this rulemaking, the Department is proposing, as an option to employers, a specimen collection methodology that is inherently a directly observed collection and a much less invasive form of direct observation drug test collection. 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, 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 use of marijuana while eliminating possibilities of positive tests resulting from passive exposure, as directed by the SUPPORT for Patients and Communities Act, Public Law 115-271, 8107(b). (See 84 FR at 57558; Oct. 25, 2019). HHS has verified the science, set the cutoffs for testing, and begun the laboratory certification process for oral fluid testing. Pursuant to the statutory directive to incorporate HHS's scientific and technical guidelines, the Department proposes to offer oral fluid testing to DOT-regulated employers as an alternative to urine testing. Using Oral Fluid Testing as an Alternative Method Can Reduce Costs We recognize that oral fluid testing is generally less expensive than urine testing. We understand that an oral fluid test can cost between $10 to $20 less than a urine testing (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 are seeking public comment on the costs of oral fluid testing as compared to urine testing so that we can affirm or adjust that cost assumption. We also seek public comment on whether DOT-regulated employers would continue to utilize the services of external qualified collectors for oral fluid, or whether employers would train their own company personnel to become qualified collectors for oral fluid testing purposes. If companies train internal personnel instead of contracting with external providers, would this be due to costs, convenience or other reasons, and what would be the cost implications of the two approaches? In addition to flexibility for employers, there are potential cost savings in the ``shy bladder'' collection procedures and related medical examinations. Currently there are situations in which a urine specimen collection is attempted but not completed. For example, when an employee is unable to provide a sufficient quantity of urine, Part 40 provides an alternative process with multiple steps. The employee receives up to three hours of time to provide a sufficient specimen and is urged to consume up to 40 ounces of fluids. If after three hours these procedures do not result in a sufficient urine specimen, the employee must be medically evaluated to determine whether there is an adequate medical explanation why the employee could not provide sufficient urine. (49 CFR 40.193 and 40.195). This involves much time on the part of the collector, employee, employer, MRO, and physician. In addition, there are the costs of medical examinations for individuals who have short-term and long-term medical conditions that cause, or are claimed to cause, an inability to provide a sufficient urine specimen. Since the Part 40 comprehensive rewrite in the late 1990s, groups representing individuals with ``Paruresis'' have raised concerns that a urine collection is problematic for individuals with this condition. Also, employees who are undergoing dialysis treatments or who have significant prostate issues could have difficulty providing a urine specimen and may require referrals to evaluating physicians to determine the legitimacy of their medical inability to provide a urine specimen. With the above in mind, collecting an oral fluid specimen may eliminate the need for a medical evaluation and result in a shorter employee visit to the collection site. Allowing Alternative Specimens Provides Flexibility to Employers In proposing oral fluid testing, the Department is not requiring employers to use oral fluid testing instead of urine testing, or for every test reason (e.g., pre-employment, random, etc.). Instead, we are proposing to offer employers the flexibility in the type of specimen they collect. That flexibility will provide several benefits. For example, when an employer determines that a DOT post-accident or a reasonable cause/suspicion test is needed, oral fluid collections could be done at the scene of the accident or the incident. The collection could be done by any oral fluid collector qualified under Part 40- either an external contractor or a DOT-regulated company employee. There are fewer requirements for oral fluid collection sites, as discussed below. The ready availability of collectors and the reduced expectations for collection site requirements should facilitate prompt, less expensive collections for post- [[Page 11159]] accident and reasonable cause/suspicion testing. We would appreciate public comments on these matters. Understanding Windows of Detection In proposing oral fluid testing, the Department is offering an alternative specimen for drug testing; however, we are not proposing to eliminate urine drug testing. Each specimen type offers different benefits to assist employers in detecting and deterring illegal drug use, and no single specimen type is perfect for every situation. It is important to understand the benefits and limitations of each method. There are different windows of detection that employers should consider when deciding whether to use a urine test or an oral fluid test as the preferred form of testing for any specific test reason. We have reviewed various scientific sources referenced below to compile the list of windows of detection, and we invite public comment, especially from oral fluid device manufacturers and laboratories, as to the accuracy of the information presented in the chart below. Any additional public comments pertaining to the accuracy and completeness of the table below would also be appreciated. ---------------------------------------------------------------------------------------------------------------- Oral fluid testing window of Urine testing window of Category of drug \1\ detection detection ---------------------------------------------------------------------------------------------------------------- Amphetamines............................. 1-3 days \2\......................... 1-9 days \2\. Methamphetamines......................... 1-4 days \2\......................... 2-4 days \2\. Cocaine.................................. 1-4 days \2\ \3\..................... 1-5 days \2\ \3\. Opioids.................................. 1-2 days \2\......................... 2-4 days \2\. Marijuana................................ Up to 24 hours \2\ \4\............... 3-67 days \2\ \5\. Phencyclidine (PCP)...................... 1-3 days \6\......................... Up to 5 days \6\. ---------------------------------------------------------------------------------------------------------------- \1\ Detection windows in the sources are dependent on amount of drug ingested, situations such as regular heavy use, and cutoff concentrations used. \2\ Cone E.J., Huestis MA. Ann N.Y. Acad Sci. 2007;1098:51-103, pp. 35-37, 42, 45-51, 54 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2700061/pdf/nihms118888.pdf . \3\ Jufer R., Walsh S.L., Cone E.J., et al. J Anal Toxicol. 2006;30(7):458-462, 460. https://academic.oup.com/jat/article/30/7/458/711502 jat/article/30/7/458/711502. \4\ Newmeyer M.N., Desrosiers N.A., Lee D., et al. Drug Test Anal. 2014;6(10):1002-1010 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4169757/pdf/nihms578748.pdf . \5\ Huestis M.A., Mitchell J.M., Cone EJ. J Anal Toxicol. 1996;20(6):441-452 https://academic.oup.com/jat/article/20/6/441/777647 article/20/6/441/777647. \6\ Cook C.E., Brine D.S., Jeffcoat A.R., et al. Clinical Pharmacology and Therapeutics. 1982; 31(5)625-634-- While the authors did not report oral fluid concentrations, they did report correlation between plasma levels and oral fluid levels. As PCP was detectable in plasma for 72 h (last time point) it is reasonable to assume PCP can also be detected in oral fluid that long. If an employer is looking to detect recent drug use, (i.e., reasonable cause/suspicion, post-accident), an employer may find that the more immediate window of detection associated with oral fluid is acceptable. However, if an employer is looking to detect a pattern of intermittent drug use through pre-employment, random, return-to-duty, follow-up testing, the delayed windows of detection in urine may be preferable. We seek comment on whether oral fluid or urine should be mandated, or prohibited, for certain test reasons, based on windows of detection. Should an employer and its service agent be allowed to opt for a different methodology if the first test cannot be completed because of an insufficient specimen or other reason? Because there is no drug testing that determines impairment, oral fluid is being introduced to detect use, as urine has done throughout the history of the DOT-regulated drug testing program. Substance Abuse Professional Remote Evaluations During the COVID-19 public health emergency, the Department recognized that it might not be possible or advisable for a SAP to meet face-to-face with a client. As a result, we issued a guidance document on April 4, 2020 to allow remote evaluations for a period of time, and we extended the guidance several times. The Department's COVID guidance was issued in 2020-2021 and can be viewed at: www.transportation.gov/odapc/Statement_of_Enforcement_Discretion_SAPs_and_Service_Agents . We said that, while a remote evaluation may not provide as much information as an in-person meeting, it is preferable to not having a SAP evaluation at all. To make a remote evaluation as effective as possible, the guidance document recommended certain technical parameters and added that SAPs should document the format of the assessment in the final SAP report. We also said that we would not view a remote evaluation as being an act of serious noncompliance meriting resort to the Public Interest Exclusion (PIE) process. Based on informal contacts with the SAP community, we believe this guidance has been well received, with a considerable use of remote evaluations by SAPs since the inception of the guidance. Moreover, it is plausible that telehealth will become a regular part of medical practice in a wide variety of fields in the future. To make remote evaluations or assessments a regular option for the SAP's practice under Part 40, we are proposing amendments to several sections of the regulation. Consistent with guidance issued in the context of the COVID-19 public health emergency, this proposal would give SAPs the option of choosing to conduct evaluations remotely in lieu of face-to-face meetings. Part 40 currently requires all SAP assessments to be done face-to-face. An in-person evaluation provides SAPs with the opportunity to objectively evaluate ``non-verbals''-- physical cues to internal feelings, thoughts, and behaviors. It allows the SAP to be aware of the client's appearance, posture, carriage, ability to make eye contact, and ability to relate in person, as well as other physical characteristics that might be indicative of problems associated with alcohol abuse and/or drug use. The most important proposed change regarding SAP evaluations is to Sec. 40.291(a)(1). The amendment would replace the current requirement for a face-to-face meeting with an option: The SAP could do the evaluation either face-to-face or remotely. If the evaluation is to be done remotely, there would be three criteria that the process would need to meet, to ensure that the SAP can still objectively evaluate ``non-verbals'' and physical characteristics to a sufficient extent. These criteria are also based on the provisions of the Department's guidance document. First, the technology used must permit real-time two-way audio and visual interaction between the SAP and the employee. A phone conversation not [[Page 11160]] including video would not meet this criterion. Second, the quality of the technology (e.g., speed of the internet connection, clarity of the display), would have to be sufficient to allow the SAP to gather all the visual and audible information the SAP would normally observe in a face-to-face interaction. In addition, the technology would have to have sufficiently robust security to protect the confidentiality of the conversation. Third, a SAP could only use the technology in question if the SAP's State-issued license authorizes the SAP to do so. The SAP's use of the technology would have to stay within the parameters of that authority (e.g., a State license may permit a practitioner to work only with clients in the State of licensure). We are also seeking public comment, especially from SAPs, regarding whether their respective State license would allow them to evaluate individuals who live in a different State from where the SAP is licensed. Is this already allowed? Now that virtual video evaluations are often done outside of the DOT-regulated context, would evaluation of individuals not in one's State of licensure be allowed? For a SAP remotely evaluating an individual outside of the SAP's locality, what steps could ensure a working knowledge of quality programs and qualified counselors available to the employee? While we continue to believe that face-to-face interactions are the ``gold standard'' for the SAP evaluations, we also believe that the remote evaluation option may have considerable merit, and we seek comment on the proposed approach, as well as on the specific technical parameters under which SAPs would perform remote virtual evaluations. We welcome comments regarding the experience of both SAP and employees under the COVID-19 guidance. We also seek comment on whether remote virtual evaluations and assessments should be limited to certain circumstances, e.g., natural disasters, pandemic situations, and where there are few or no SAPs available. Other Matters of Interest As noted above, the Department works closely with HHS on matters concerning workplace drug testing. On September 10, 2020, HHS published a notice of proposed Mandatory Guidelines proposing to add hair testing to the drug testing specimen types authorized for the Federal employee testing program. (85 FR 56108). Because HHS is still considering amendments to its Mandatory Guidelines to permit hair testing, comments to DOT concerning the use of hair testing are not relevant at this time. In addition, we are proposing to amend Sec. 40.67 to address situations where a same gender observer is not available for the collection of urine specimens. Specifically, we request public comment on allowing direct observations by any licensed or certified medical professional legally authorized to take part in a medical examination in the jurisdiction where the collection takes place. Currently, per Sec. 40.141(b), MROs must personally contact pharmacies to verify a prescription that an employee has cited as a potential legitimate medical explanation for a laboratory-confirmed positive test. We believe it would increase efficiency and assist MRO office workflow if MRO staff were able to make these inquiries. The Department seeks comment on whether this change is advisable and what the estimated cost savings would be. In addition to the above, we request comments on whether there are situations in which a test, once cancelled, should be ``uncancelled'' if circumstances dictate (e.g., a test is cancelled because paperwork is missing or delayed, but the paperwork is later found and provided to the MRO). Or, alternatively, should a test, once cancelled, remain cancelled to ensure finality? We specifically seek comment from MROs on the practicality of administering such a process, and from employers on the effect that an ``uncancelled'' test would have when administering their drug testing program. To be clear, this would not apply to those specimens ``rejected'' by the laboratory because of a fatal flaw and ultimately reported by the MRO as cancelled. We have proposed language in Sec. 40.207(d) to address this circumstance. We have also included a requirement for a party seeking to reverse a cancellation to consult ODAPC if the decision is being made more than 60 days after the cancellation, which is the same consultation requirement we have in Sec. 40.149(a)(4), where we allow an MRO to reopen a verified test after 60 days. Providing this information helps ODAPC to provide advice to MROs regarding what to consider and potential concerns. V. Section-by-Section Analysis In drafting the proposed oral fluid amendments to Part 40, the Department is not creating a separate subpart of Part 40 concerning oral fluid testing. Since many of the provisions of Part 40 can be applied to specimen types in addition to urine, we have sought to integrate provisions concerning oral fluid testing within the current Part 40 structure. However, since the provisions applicable to Alcohol Testing, SAPs, the PIE process, and some other provisions would not change based on which specimen types are authorized, we are not proposing changes to those provisions. Consistent with changes made in the substantive provisions of the rule, we propose to modify some section titles as well as adding new sections. In many cases, the modifications revise current titles specifying urine testing so that they address oral fluid and potential future testing matrices. 40.3 What do the terms used in this part mean? In addition to proposing to delete the definition of ``screening drug test'' because the term is not used in Part 40, the proposed rule would delete the definition of ``Invalid drug test'' because that is a term that HHS does not use, as such. The term ``invalid result'' is an HHS term with a very specific meaning and HHS does not have a defined term of ``Invalid drug test.'' The term ``invalid'' is sometimes misunderstood in arbitrations, courtrooms, and other settings to incorrectly suggest a lack of certainty about the underlying testing event. A laboratory reporting an invalid result to the MRO does not mean that the underlying drug testing event was not valid. For example, when the laboratory reports that there was an ``invalid result,'' it is not a characterization of the employer's authority to conduct the testing, the collection process, etc. The ``invalid result'' refers only to the fact that the laboratory has not been able to complete testing or obtain a valid drug test result (e.g., because of an unidentified adulterant, an interfering substance, or an abnormal physical characteristic). Also, for consistency with HHS terminology, we are removing the defined term ``invalid drug test'' in the definitions section, Sec. 40.3, and are updating Sec. Sec. 40.123(c), 40.129(a) and 40.129(d) to use the term ``invalid result''. The proposal would add definitions of seven terms as part of our effort to harmonize Part 40 with the HHS Guidelines and to update Part 40 as needed. An ``alternative specimen'' is an authorized specimen of a type other than the one previously collected. For example, in a case where the initial collection was urine, oral fluid would be an alternative specimen. The ``cutoff'' is the quantitative point distinguishing a need for further testing or whether a laboratory result, for example, is [[Page 11161]] positive or negative (e.g., 2 ng/ml is the confirmatory test cutoff for a positive vs. negative oral fluid result reported by the laboratory for THC). We are also proposing to add definitions for ``oral fluid specimen'' and ``urine specimen.'' ``Specimen'' is the generic term for any fluid, breath or material collected from someone for a drug or alcohol test. We are proposing to add ``Undiluted (neat) oral fluid'', using the same language HHS uses in Section 1.5 of its Oral Fluid Mandatory Guidelines. We have also added a definition for the FMCSA's Commercial Driver's License (CDL) Drug and Alcohol Clearinghouse (Clearinghouse). We are also proposing to add a new definition for ``SSN or Employee ID No.'', and some minor changes to rule language in Sec. Sec. 40.14, 40.45, 40.97, 40.163 and 40.311 for the following reasons. Since its inception in 1988, Part 40 has required program participants to use the donor's Social Security Number (SSN) or an employee identification (ID) number in various sections. For example, the employer must supply the collection site with the ``Donor SSN, Employee I.D., or CDL State and No.'' as referenced on the Federal Drug Testing Custody and Control Form (CCF). For the Alcohol Testing Form (ATF), the employer must supply the donor's ``SSN or Employee ID No.'' In addition to the unique specimen ID number on the CCF and the specimen seals, having the SSN or employee ID number on the form assists the MRO in matching the Copy 1 of the CCF from the laboratory with their copy, Copy 2 of the CCF. The SSN or the employee ID number may be used by the employer to, for example, run random selection lists and ensure that test results are associated with the correct employee. The SAP is required to utilize the SSN on the SAP initial and final reports to the employer. In the Federal Motor Carrier Safety Administration's (FMCSA) Commercial Driver's License Clearinghouse final rule (81 FR 87686; Dec. 5, 2016), which required the creation of the Drug and Alcohol Clearinghouse database (Clearinghouse), the FMCSA amended 49 CFR 382.123(a) and (b) to require that, for FMCSA-regulated drivers undergoing DOT-regulated testing, the employer use a Commercial Driver's License (CDL) number and State of issuance, instead of the SSN or other employee ID number, on the CCF and Alcohol Testing Form (ATF) for all drug and alcohol tests conducted under part 382. It is important to note that the Clearinghouse final rule did not affect or otherwise allow use of the CDL number for a CDL driver operating under another DOT agency's regulation and subject to a test not under Part 382 (e.g., employers of CDL drivers under PHMSA or FTA).
- **truncated:** true
- **body characters:** 214722